Food and Drugs

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21 Parts 170 to 199 Revised as of April 1, 2004

Food and Drugs

Containing a codification of documents of general applicability and future effect

As of April 1, 2004

With Ancillaries

Published by Office of the Federal Register National Archives and Records Administration

A Special Edition of the Federal Register

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For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; DC area (202) 512-1800 Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402–0001

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Page Explanation ...... v

Title 21:

Chapter I—Food and Drug Administration, Department of Health and Human Services (Continued) ...... 3

Finding Aids:

Material Approved for Incorporation by Reference ...... 583

Table of CFR Titles and Chapters ...... 599

Alphabetical List of Agencies Appearing in the CFR ...... 617

List of CFR Sections Affected ...... 627

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To cite the regulations in this volume use title, part and section number. Thus, 21 CFR 170.3 refers to title 21, part 170, section 3.

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The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further sub- divided into parts covering specific regulatory areas. Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis approximately as follows: Title 1 through Title 16...... as of January 1 Title 17 through Title 27 ...... as of April 1 Title 28 through Title 41 ...... as of July 1 Title 42 through Title 50...... as of October 1 The appropriate revision date is printed on the cover of each volume. LEGAL STATUS The contents of the Federal Register are required to be judicially noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text of the original documents (44 U.S.C. 1510). HOW TO USE THE CODE OF FEDERAL REGULATIONS The Code of Federal Regulations is kept up to date by the individual issues of the Federal Register. These two publications must be used together to determine the latest version of any given rule. To determine whether a Code volume has been amended since its revision date (in this case, April 1, 2004), consult the ‘‘List of CFR Sections Affected (LSA),’’ which is issued monthly, and the ‘‘Cumulative List of Parts Affected,’’ which appears in the Reader Aids section of the daily Federal Register. These two lists will identify the Federal Register page number of the latest amendment of any given rule. EFFECTIVE AND EXPIRATION DATES Each volume of the Code contains amendments published in the Federal Reg- ister since the last revision of that volume of the Code. Source citations for the regulations are referred to by volume number and page number of the Federal Register and date of publication. Publication dates and effective dates are usually not the same and care must be exercised by the user in determining the actual effective date. In instances where the effective date is beyond the cut- off date for the Code a note has been inserted to reflect the future effective date. In those instances where a regulation published in the Federal Register states a date certain for expiration, an appropriate note will be inserted following the text. OMB CONTROL NUMBERS The Paperwork Reduction Act of 1980 (Pub. L. 96–511) requires Federal agencies to display an OMB control number with their information collection request.

VerDate jul<14>2003 12:50 May 06, 2004 Jkt 203066 PO 00000 Frm 00005 Fmt 8008 Sfmt 8092 Y:\SGML\203066F.XXX 203066F Many agencies have begun publishing numerous OMB control numbers as amendments to existing regulations in the CFR. These OMB numbers are placed as close as possible to the applicable recordkeeping or reporting requirements. OBSOLETE PROVISIONS Provisions that become obsolete before the revision date stated on the cover of each volume are not carried. Code users may find the text of provisions in effect on a given date in the past by using the appropriate numerical list of sections affected. For the period before January 1, 2001, consult either the List of CFR Sections Affected, 1949–1963, 1964–1972, 1973–1985, or 1986–2000, published in 11 separate volumes. For the period beginning January 1, 2001, a ‘‘List of CFR Sections Affected’’ is published at the end of each CFR volume. INCORPORATION BY REFERENCE What is incorporation by reference? Incorporation by reference was established by statute and allows Federal agencies to meet the requirement to publish regulations in the Federal Register by referring to materials already published else- where. For an incorporation to be valid, the Director of the Federal Register must approve it. The legal effect of incorporation by reference is that the material is treated as if it were published in full in the Federal Register (5 U.S.C. 552(a)). This material, like any other properly issued regulation, has the force of law. What is a proper incorporation by reference? The Director of the Federal Register will approve an incorporation by reference only when the requirements of 1 CFR part 51 are met. Some of the elements on which approval is based are: (a) The incorporation will substantially reduce the volume of material published in the Federal Register. (b) The matter incorporated is in fact available to the extent necessary to afford fairness and uniformity in the administrative process. (c) The incorporating document is drafted and submitted for publication in accordance with 1 CFR part 51. Properly approved incorporations by reference in this volume are listed in the Finding Aids at the end of this volume. What if the material incorporated by reference cannot be found? If you have any problem locating or obtaining a copy of material listed in the Finding Aids of this volume as an approved incorporation by reference, please contact the agency that issued the regulation containing that incorporation. If, after contacting the agency, you find the material is not available, please notify the Director of the Federal Register, National Archives and Records Administration, Washington DC 20408, or call (202) 741–6010. CFR INDEXES AND TABULAR GUIDES A subject index to the Code of Federal Regulations is contained in a separate volume, revised annually as of January 1, entitled CFR INDEX AND FINDING AIDS. This volume contains the Parallel Table of Statutory Authorities and Agency Rules (Table I). A list of CFR titles, chapters, and parts and an alphabetical list of agencies publishing in the CFR are also included in this volume. An index to the text of ‘‘Title 3—The President’’ is carried within that volume. The Federal Register Index is issued monthly in cumulative form. This index is based on a consolidation of the ‘‘Contents’’ entries in the daily Federal Reg- ister. A List of CFR Sections Affected (LSA) is published monthly, keyed to the revision dates of the 50 CFR titles.

VerDate jul<14>2003 12:50 May 06, 2004 Jkt 203066 PO 00000 Frm 00006 Fmt 8008 Sfmt 8092 Y:\SGML\203066F.XXX 203066F REPUBLICATION OF MATERIAL There are no restrictions on the republication of material appearing in the Code of Federal Regulations. INQUIRIES For a legal interpretation or explanation of any regulation in this volume, contact the issuing agency. The issuing agency’s name appears at the top of odd-numbered pages. For inquiries concerning CFR reference assistance, call 202–741–6000 or write to the Director, Office of the Federal Register, National Archives and Records Administration, Washington, DC 20408 or e-mail [email protected]. SALES The Government Printing Office (GPO) processes all sales and distribution of the CFR. For payment by credit card, call toll free, 866–512–1800 or DC area, 202– 512–1800, M–F, 8 a.m. to 4 p.m. e.s.t. or fax your order to 202–512–2250, 24 hours a day. For payment by check, write to the Superintendent of Documents, Attn: New Orders, P.O. Box 371954, Pittsburgh, PA 15250–7954. For GPO Customer Serv- ice call 202–512–1803. ELECTRONIC SERVICES The full text of the Code of Federal Regulations, The United States Govern- ment Manual, the Federal Register, Public Laws, Public Papers, Weekly Compila- tion of Presidential Documents and the Privacy Act Compilation are available in electronic format at www.gpoaccess.gov/nara. For more information, contact Electronic Information Dissemination Services, U.S. Government Printing Office. Phone 202–512–1530, or 888–293–6498 (toll-free). E-mail, [email protected]. The Office of the Federal Register also offers a free service on the National Archives and Records Administration’s (NARA) World Wide Web site for public law numbers, Federal Register finding aids, and related information. Connect to NARA’s web site at www.archives.gov/federallregister. The NARA site also contains links to GPO Access.

RAYMOND A. MOSLEY, Director, Office of the Federal Register. April 1, 2004.

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Title 21—FOOD AND DRUGS is composed of nine volumes. The parts in these volumes are arranged in the following order: Parts 1–99, 100–169, 170–199, 200–299, 300–499, 500–599, 600–799, 800–1299 and 1300–end. The first eight volumes, containing parts 1–1299, comprise Chapter I—Food and Drug Administration, Department of Health and Human Services. The ninth volume, containing part 1300 to end, includes Chapter II—Drug Enforcement Administration, Department of Justice, and Chapter III—Office of National Drug Control Policy. The contents of these volumes represent all current regulations codified under this title of the CFR as of April 1, 2004.

For this volume, Bonnie Fritts was Chief Editor. The Code of Federal Regula- tions publication program is under the direction of Frances D. McDonald, assisted by Alomha S. Morris.

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VerDate jul<14>2003 12:50 May 06, 2004 Jkt 203066 PO 00000 Frm 00010 Fmt 8092 Sfmt 8092 Y:\SGML\203066F.XXX 203066F CFRORDR.FRM Title 21—Food and Drugs

(This book contains parts 170 to 199)

Part

CHAPTER I—Food and Drug Administration, Department of Health and Human Services (Continued) ...... 170

CROSS REFERENCES: Food Safety and Inspection Service, Department of Agriculture: See Meat and Poultry Inspection, 9 CFR chapter III. Federal Trade Commission: See Commercial Practices, 16 CFR chapter I. United States Customs Service, Department of the Treasury: See Customs Duties, 19 CFR chapter I. Internal Revenue Service, Department of the Treasury: See Internal Revenue, 26 CFR chapter I. Bureau of Alcohol, Tobacco, and Firearms, Department of the Treasury: See Alcohol, To- bacco Products and Firearms, 27 CFR chapter I.

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(Parts 170 to 199)

EDITORIAL NOTE: The Food and Drug Administration published a document at 49 FR 41019, Oct. 19, 1984, establishing July 1, 1987, as a uniform effective date for compliance for regulations affecting the labeling of food products. At 51 FR 34085, Sept. 25, 1986, FDA established January 1, 1989 as a new uniform effective date for compliance. The new uniform effective date will apply only to final FDA food labeling regulations published after July 1, 1986, and before January 1, 1988. At 55 FR 276, Jan. 4, 1990, FDA established January 1, 1993 as a new uniform effective date for compliance. The new uniform effective date will apply only to final FDA food labeling regulations published after January 1, 1990 and before January 1, 1992. EDITORIAL NOTE: For nomenclature changes to chapter I see 59 FR 14366, Mar. 28, 1994.

SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (CONTINUED)

Part Page 170 Food additives ...... 5 171 Food additive petitions ...... 24 172 Food additives permitted for direct addition to food for human consumption ...... 30 173 Secondary direct food additives permitted in food for human consumption ...... 117 174 Indirect food additives: General ...... 148 175 Indirect food additives: Adhesives and components of coatings ...... 149 176 Indirect food additives: Paper and paperboard components ...... 191 177 Indirect food additives: Polymers ...... 229 178 Indirect food additives: Adjuvants, production aids, and sanitizers ...... 348 179 Irradiation in the production, processing and handling of food ...... 440 180 Food additives permitted in food or in contact with food on an interim basis pending additional study ...... 446 181 Prior-sanctioned food ingredients ...... 451 182 Substances generally recognized as safe ...... 456 3

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Part Page 184 Direct food substances affirmed as generally recognized as safe ...... 469 186 Indirect food substances affirmed as generally recognized as safe ...... 567 189 Substances prohibited from use in human food ...... 572 190 Dietary supplements ...... 577 191–199 [Reserved]

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PART 170—FOOD ADDITIVES 170.106 Notification for a food contact substance formulation (NFCSF). Subpart A—General Provisions AUTHORITY: 21 U.S.C. 321, 341, 342, 346a, 348, 371. Sec. 170.3 Definitions. SOURCE: 42 FR 14483, Mar. 15, 1977, unless 170.6 Opinion letters on food additive sta- otherwise noted. tus. EDITORIAL NOTE: Nomenclature changes to 170.10 Food additives in standardized foods. part 170 appear at 66 FR 56035, Nov. 6, 2001 170.15 Adoption of regulation on initiative and 69 FR 13717, Mar. 24, 2004. of Commissioner. 170.17 Exemption for investigational use and procedure for obtaining authoriza- Subpart A—General Provisions tion to market edible products from experimental animals. § 170.3 Definitions. 170.18 Tolerances for related food additives. For the purposes of this subchapter, 170.19 Pesticide chemicals in processed the following definitions apply: foods. (a) Secretary means the Secretary of Health and Human Services. Subpart B—Food Additive Safety (b) Department means the Department 170.20 General principles for evaluating the of Health and Human Services. safety of food additives. (c) Commissioner means the Commis- 170.22 Safety factors to be considered. sioner of Food and Drugs. 170.30 Eligibility for classification as gen- (d) As used in this part, the term act erally recognized as safe (GRAS). means the Federal Food, Drug, and 170.35 Affirmation of generally recognized as safe (GRAS) status. Cosmetic Act approved June 25, 1936, 52 170.38 Determination of food additive sta- Stat. 1040 et seq., as amended (21 U.S.C. tus. 301–392). 170.39 Threshold of regulation for sub- (e)(1) Food additives includes all substances used in food-contact articles. stances not exempted by section 201(s) of the act, the intended use of which Subpart C—Specific Administrative Rulings results or may reasonably be expected and Decisions to result, directly or indirectly, either 170.45 Fluorine-containing compounds. in their becoming a component of food 170.50 Glycine (aminoacetic acid) in food for or otherwise affecting the characteris- human consumption. tics of food. A material used in the pro- 170.60 Nitrites and/or nitrates in curing pre- duction of containers and packages is mixes. subject to the definition if it may reasonably be expected to become a com- Subpart D—Premarket Notifications ponent, or to affect the characteristics, 170.100 Submission of a premarket notifica- directly or indirectly, of food packed in tion for a food contact substance (FCN) the container. ‘‘Affecting the charac- to the Food and Drug Administration teristics of food’’ does not include such (FDA). physical effects, as protecting contents 170.101 Information in a premarket notification for a food contact substance (FCN). of packages, preserving shape, and pre- 170.102 Confidentiality of information in a venting moisture loss. If there is no premarket notification for a food contact migration of a packaging component substance (FCN). from the package to the food, it does 170.103 Withdrawal without prejudice of a not become a component of the food premarket notification for a food contact and thus is not a food additive. A sub- substance (FCN). stance that does not become a compo- 170.104 Action on a premarket notification nent of food, but that is used, for exam- for a food contact substance (FCN). 170.105 The Food and Drug Administration’s ple, in preparing an ingredient of the (FDA’s) determination that a premarket food to give a different flavor, texture, notification for a food contact substance or other characteristic in the food, (FCN) is no longer effective. may be a food additive.

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(2) Uses of food additives not requiring (j) The term nonperishable processed a listing regulation. Use of a substance food means any processed food not sub- in a food contact article (e.g., food- ject to rapid decay or deterioration packaging or food-processing equip- that would render it unfit for consump- ment) whereby the substance migrates, tion. Examples are flour, sugar, cere- or may reasonably be expected to mi- als, packaged cookies, and crackers. grate, into food at such levels that the Not included are hermetically sealed use has been exempted from regulation foods or manufactured dairy products as a food additive under § 170.39, and and other processed foods requiring re- food contact substances used in accord- frigeration. ance with a notification submitted (k) General recognition of safety shall under section 409(h) of the act that is be determined in accordance with effective. § 170.30. (3) A food contact substance is any sub- (l) Prior sanction means an explicit stance that is intended for use as a component of materials used in manu- approval granted with respect to use of facturing, packing, packaging, trans- a substance in food prior to September porting, or holding food if such use is 6, 1958, by the Food and Drug Adminis- not intended to have any technical ef- tration or the United States Depart- fect in such food. ment of Agriculture pursuant to the (f) Common use in food means a sub- Federal Food, Drug, and Cosmetic Act, stantial history of consumption of a the Poultry Products Inspection Act, substance for food use by a significant or the Meat Inspection Act. number of consumers. (m) Food includes human food, sub- (g) The word substance in the defini- stances migrating to food from food- tion of the term ‘‘food additive’’ in- contact articles, pet food, and animal cludes a food or food component con- feed. sisting of one or more ingredients. (n) The following general food cat- (h) Scientific procedures include those egories are established to group spe- human, animal, analytical, and other cific related foods together for the pur- scientific studies, whether published or pose of establishing tolerances or limi- unpublished, appropriate to establish tations for the use of direct human the safety of a substance. food ingredients. Individual food prod- (i) Safe or safety means that there is ucts will be included within these cat- a reasonable certainty in the minds of egories according to the detailed clas- competent scientists that the sub- sifications lists contained in Exhibit stance is not harmful under the in- 33B of the report of the National Acad- tended conditions of use. It is impos- emy of Sciences/National Research sible in the present state of scientific Council report, ‘‘A Comprehensive Sur- knowledge to establish with complete vey of Industry on the Use of Food certainty the absolute harmlessness of Chemicals Generally Recognized as the use of any substance. Safety may Safe’’ (September 1972), which is incor- be determined by scientific procedures porated by reference. Copies are avail- or by general recognition of safety. In able from the National Technical Infor- determining safety, the following fac- mation Service (NTIS), 5285 Port Royal tors shall be considered: Rd., Springfield, VA 22161, or available (1) The probable consumption of the substance and of any substance formed for inspection at the Office of the Fed- in or on food because of its use. eral Register, 800 North Capitol Street, (2) The cumulative effect of the sub- NW., suite 700, Washington, DC 20408: stance in the diet, taking into account (1) Baked goods and baking mixes, in- any chemically or pharmacologically cluding all ready-to-eat and ready-to- related substance or substances in such bake products, flours, and mixes re- diet. quiring preparation before serving. (3) Safety factors which, in the opin- (2) Beverages, alcoholic, including ion of experts qualified by scientific malt beverages, wines, distilled liq- training and experience to evaluate the uors, and cocktail mix. safety of food and food ingredients, are (3) Beverages and beverage bases, generally recognized as appropriate. nonalcoholic, including only special or

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spiced teas, soft drinks, coffee sub- containing dishes, salads, appetizers, or stitutes, and fruit and vegetable fla- sandwich spreads made therefrom. vored gelatin drinks. (19) Fresh vegetables, tomatoes, and (4) Breakfast cereals, including potatoes, including only fresh and ready-to-eat and instant and regular home-prepared vegetables. hot cereals. (20) Frozen dairy desserts and mixes, (5) Cheeses, including curd and whey including ice cream, ice milks, sher- cheeses, cream, natural, grating, proc- bets, and other frozen dairy desserts essed, spread, dip, and miscellaneous and specialties. cheeses. (21) Fruit and water ices, including (6) Chewing gum, including all forms. all frozen fruit and water ices. (7) Coffee and tea, including regular, (22) Gelatins, puddings, and fillings, decaffeinated, and instant types. including flavored gelatin desserts, (8) Condiments and relishes, includ- puddings, custards, parfaits, pie filling plain seasoning sauces and spreads, ings, and gelatin base salads. olives, pickles, and relishes, but not (23) Grain products and pastas, in- spices or herbs. cluding macaroni and noodle products, (9) Confections and frostings, includ- rice dishes, and frozen multicourse ing candy and flavored frostings, meals, without meat or vegetables. marshmallows, baking chocolate, and (24) Gravies and sauces, including all brown, lump, rock, maple, powdered, meat sauces and gravies, and tomato, and raw sugars. milk, buttery, and specialty sauces. (10) Dairy product analogs, including (25) Hard candy and cough drops, in- nondairy milk, frozen or liquid cream- cluding all hard type candies. ers, coffee whiteners, toppings, and (26) Herbs, seeds, spices, seasonings, other nondairy products. blends, extracts, and flavorings, includ- (11) Egg products, including liquid, ing all natural and artificial spices, frozen, or dried eggs, and egg dishes blends, and flavors. made therefrom, i.e., egg roll, egg foo (27) Jams and jellies, home-prepared, young, egg salad, and frozen multi- including only home-prepared jams, course egg meals, but not fresh eggs. jellies, fruit butters, preserves, and (12) Fats and oils, including mar- sweet spreads. garine, dressings for salads, butter, (28) Jams and jellies, commercial, in- salad oils, shortenings and cooking cluding only commercially processed oils. jams, jellies, fruit butters, preserves, (13) Fish products, including all pre- and sweet spreads. pared main dishes, salads, appetizers, (29) Meat products, including all frozen multicourse meals, and spreads meats and meat containing dishes, sal- containing fish, shellfish, and other ads, appetizers, frozen multicourse aquatic animals, but not fresh fish. meat meals, and sandwich ingredients (14) Fresh eggs, including cooked prepared by commercial processing or eggs and egg dishes made only from using commercially processed meats fresh shell eggs. with home preparation. (15) Fresh fish, including only fresh (30) Milk, whole and skim, including and frozen fish, shellfish, and other only whole, lowfat, and skim fluid aquatic animals. milks. (16) Fresh fruits and fruit juices, in- (31) Milk products, including flavored cluding only raw fruits, citrus, melons, milks and milk drinks, dry milks, top- and berries, and home-prepared ‘‘ades’’ pings, snack dips, spreads, weight con- and punches made therefrom. trol milk beverages, and other milk or- (17) Fresh meats, including only fresh igin products. or home-frozen beef or veal, pork, lamb (32) Nuts and nut products, including or mutton and home-prepared fresh whole or shelled tree nuts, peanuts, co- meat-containing dishes, salads, appe- conut, and nut and peanut spreads. tizers, or sandwich spreads made there- (33) Plant protein products, including from. the National Academy of Sciences/Na- (18) Fresh poultry, including only tional Research Council ‘‘reconstituted fresh or home-frozen poultry and game vegetable protein’’ category, and meat, birds and home-prepared fresh poultry- poultry, and fish substitutes, analogs,

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and extender products made from plant North Capitol Street, NW., suite 700, proteins. Washington, DC 20408: (34) Poultry products, including all (1) ‘‘Anticaking agents and free-flow poultry and poultry-containing dishes, agents’’: Substances added to finely salads, appetizers, frozen multicourse powdered or crystalline food products poultry meals, and sandwich ingredi- to prevent caking, lumping, or agglom- ents prepared by commercial proc- eration. essing or using commercially processed (2) ‘‘Antimicrobial agents’’: Sub- poultry with home preparation. stances used to preserve food by pre- (35) Processed fruits and fruit juices, venting growth of microorganisms and including all commercially processed subsequent spoilage, including fungi- fruits, citrus, berries, and mixtures; stats, mold and rope inhibitors, and the salads, juices and juice punches, con- effects listed by the National Academy centrates, dilutions, ‘‘ades’’, and drink of Sciences/National Research Council substitutes made therefrom. under ‘‘preservatives.’’ (36) Processed vegetables and vege- (3) ‘‘Antioxidants’’: Substances used table juices, including all commer- to preserve food by retarding deteriora- cially processed vegetables, vegetable tion, rancidity, or discoloration due to dishes, frozen multicourse vegetable oxidation. meals, and vegetable juices and blends. (4) ‘‘Colors and coloring adjuncts’’: (37) Snack foods, including chips, Substances used to impart, preserve, or pretzels, and other novelty snacks. enhance the color or shading of a food, (38) Soft candy, including candy bars, including color stabilizers, color fixa- chocolates, fudge, mints, and other tives, color-retention agents, etc. chewy or nougat candies. (5) ‘‘Curing and pickling agents’’: (39) Soups, home-prepared, including Substances imparting a unique flavor meat, fish, poultry, vegetable, and and/or color to a food, usually pro- combination home-prepared soups. ducing an increase in shelf life sta- (40) Soups and soup mixes, including bility. commercially prepared meat, fish, poultry, vegetable, and combination (6) ‘‘Dough strengtheners’’: Sub- soups and soup mixes. stances used to modify starch and glu- (41) Sugar, white, granulated, includ- ten, thereby producing a more stable ing only white granulated sugar. dough, including the applicable effects (42) Sugar substitutes, including listed by the National Academy of granulated, liquid, and tablet sugar Sciences/National Research Council substitutes. under ‘‘dough conditioner.’’ (43) Sweet sauces, toppings, and syr- (7) ‘‘Drying agents’’: Substances with ups, including chocolate, berry, fruit, moisture-absorbing ability, used to corn syrup, and maple sweet sauces and maintain an environment of low mois- toppings. ture. (o) The following terms describe the (8) ‘‘Emulsifiers and emulsifier physical or technical functional effects salts’’: Substances which modify sur- for which direct human food ingredi- face tension in the component phase of ents may be added to foods. They are an emulsion to establish a uniform dis- adopted from the National Academy of persion or emulsion. Sciences/National Research Council na- (9) ‘‘Enzymes’’: Enzymes used to im- tional survey of food industries, re- prove food processing and the quality ported to the Food and Drug Adminis- of the finished food. tration under the contract title ‘‘A (10) ‘‘Firming agents’’: Substances Comprehensive Survey of Industry on added to precipitate residual pectin, the Use of Food Chemicals Generally thus strengthening the supporting tis- Recognized as Safe’’ (September 1972), sue and preventing its collapse during which is incorporated by reference. processing. Copies are available from the National (11) ‘‘Flavor enhancers’’: Substances Technical Information Service (NTIS), added to supplement, enhance, or mod- 5285 Port Royal Rd., Springfield, VA ify the original taste and/or aroma of a 22161, or available for inspection at the food, without imparting a char- Office of the Federal Register, 800 acteristic taste or aroma of its own.

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(12) ‘‘Flavoring agents and adju- (24) ‘‘Processing aids’’: Substances vants’’: Substances added to impart or used as manufacturing aids to enhance help impart a taste or aroma in food. the appeal or utility of a food or food (13) ‘‘Flour treating agents’’: Sub- component, including clarifying stances added to milled flour, at the agents, clouding agents, catalysts, floc- mill, to improve its color and/or baking culents, filter aids, and crystallization qualities, including bleaching and ma- inhibitors, etc. turing agents. (25) ‘‘Propellants, aerating agents, (14) ‘‘Formulation aids’’: Substances and gases’’: Gases used to supply force used to promote or produce a desired to expel a product or used to reduce the physical state or texture in food, in- amount of oxygen in contact with the cluding carriers, binders, fillers, plasti- food in packaging. cizers, film-formers, and tableting aids, (26) ‘‘Sequestrants’’: Substances etc. which combine with polyvalent metal (15) ‘‘Fumigants’’: Volatile sub- ions to form a soluble metal complex, stances used for controlling insects or to improve the quality and stability of pests. products. (16) ‘‘Humectants’’: Hygroscopic sub- (27) ‘‘Solvents and vehicles’’: Sub- stances incorporated in food to pro- stances used to extract or dissolve an- mote retention of moisture, including other substance. moisture-retention agents and anti- (28) ‘‘Stabilizers and thickeners’’: dusting agents. Substances used to produce viscous so- (17) ‘‘Leavening agents’’: Substances lutions or dispersions, to impart body, used to produce or stimulate produc- improve consistency, or stabilize emul- tion of carbon dioxide in baked goods sions, including suspending and body- to impart a light texture, including ing agents, setting agents, jellying yeast, yeast foods, and calcium salts agents, and bulking agents, etc. listed by the National Academy of (29) ‘‘Surface-active agents’’: Sub- Sciences/National Research Council stances used to modify surface prop- under ‘‘dough conditioners.’’ erties of liquid food components for a (18) ‘‘Lubricants and release agents’’: variety of effects, other than emulsi- Substances added to food contact sur- fiers, but including solubilizing agents, faces to prevent ingredients and fin- dispersants, detergents, wetting ished products from sticking to them. agents, rehydration enhancers, whip- (19) ‘‘Non-nutritive sweeteners’’: Sub- ping agents, foaming agents, and de- stances having less than 2 percent of foaming agents, etc. the caloric value of sucrose per equiva- (30) ‘‘Surface-finishing agents’’: Sub- lent unit of sweetening capacity. stances used to increase palatability, (20) ‘‘Nutrient supplements’’: Sub- preserve gloss, and inhibit discolora- stances which are necessary for the tion of foods, including glazes, polishes, body’s nutritional and metabolic proc- waxes, and protective coatings. esses. (31) ‘‘Synergists’’: Substances used to (21) ‘‘Nutritive sweeteners’’: Sub- act or react with another food ingre- stances having greater than 2 percent dient to produce a total effect different of the caloric value of sucrose per or greater than the sum of the effects equivalent unit of sweetening capacity. produced by the individual ingredients. (22) ‘‘Oxidizing and reducing agents’’: (32) ‘‘Texturizers’’: Substances which Substances which chemically oxidize affect the appearance or feel of the or reduce another food ingredient, food. thereby producing a more stable prod- [42 FR 14483, Mar. 15, 1977, as amended at 47 uct, including the applicable effect list- FR 11835, Mar. 19, 1982; 53 FR 16546, May 10, ed by the National Academy of 1988; 54 FR 24896, June 12, 1989; 60 FR 36595, Sciences/National Research Council July 17, 1995; 67 FR 35729, May 21, 2002] under ‘‘dough conditioners.’’ (23) ‘‘pH control agents’’: Substances § 170.6 Opinion letters on food addi- added to change or maintain active tive status. acidity or basicity, including buffers, (a) Over the years the Food and Drug acids, alkalies, and neutralizing Administration has given informal agents. written opinions to inquiries as to the

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safety of articles intended for use as such letter forwards a copy of each to components of, or in contact with, the Department of Health and Human food. Prior to the enactment of the Services, Food and Drug Administra- Food Additives Amendment of 1958 tion, Center for Food Safety and Ap- (Pub. L. 85–929; Sept. 6, 1958), these plied Nutrition, 5100 Paint Branch opinions were given pursuant to sec- Pkwy., College Park, MD 20740, along tion 402(a)(1) of the Federal Food, with a copy of his letter of inquiry, on Drug, and Cosmetic Act, which reads in or before July 23, 1970. part: ‘‘A food shall be deemed to be (f) This section does not apply to food adulterated if it bears or contains any additive status opinion letters per- poisonous or deleterious substance taining to articles that were considered which may render it injurious to by the Food and Drug Administration health’’. to be food additives nor to articles in- (b) Since enactment of the Food Ad- cluded in regulations in parts 170 ditives Amendment, the Food and Drug through 189 of this chapter if the arti- Administration has advised such in- cles are used in accordance with the re- quirers that an article: quirements of such regulations. (1) Is a food additive within the meaning of section 201(s) of the act; or [42 FR 14483, Mar. 15, 1977, as amended at 54 (2) Is generally recognized as safe FR 24896, June 12, 1989] (GRAS); or (3) Has prior sanction or approval § 170.10 Food additives in standardized foods. under that amendment; or (4) Is not a food additive under the (a) The inclusion of food ingredients conditions of intended use. in parts 170 through 189 of this chapter (c) In the interest of the public does not imply that these ingredients health, such articles which have been may be used in standardized foods un- considered in the past by the Food and less they are recognized as optional in- Drug Administration to be safe under gredients in applicable food standards. the provisions of section 402(a)(1), or to Where a petition is received for the be generally recognized as safe for issuance or amendment of a regulation their intended use, or to have prior establishing a definition and standard sanction or approval, or not to be food of identity for a food under section 401 additives under the conditions of in- of the Act, which proposes the inclu- tended use, must be reexamined in the sion of a food additive in such defini- light of current scientific information tion and standard of identity, the pro- and current principles for evaluating visions of the regulations in this part the safety of food additives if their use shall apply with respect to the infor- is to be continued. mation that must be submitted with (d) Because of the time span in- respect to the food additive. Since sec- volved, copies of many of the letters in tion 409(b)(5) of the Act requires that which the Food and Drug Administra- the Secretary publish notice of a petition has expressed an informal opinion tion for the establishment of a food-ad- concerning the status of such articles ditive regulation within 30 days after may no longer be in the file of the Food filing, notice of a petition relating to a and Drug Administration. In the ab- definition and standard of identity sence of information concerning the shall also be published within that names and uses made of all the articles time limitation if it includes a request, referred to in such letters, their safety so designated, for the establishment of of use cannot be reexamined. For this a regulation pertaining to a food addi- reason all food additive status opinions tive. of the kind described in paragraph (c) (b) If a petition for a definition and of this section given by the Food and standard of identity contains a pro- Drug Administration are hereby re- posal for a food-additive regulation, voked. and the petitioner fails to designate it (e) The prior opinions of the kind de- as such, the Commissioner, upon deter- scribed in paragraph (c) of this section mining that the petition includes a will be replaced by qualified and cur- proposal for a food-additive regulation, rent opinions if the recipient of each shall so notify the petitioner and shall

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thereafter proceed in accordance with products as food has been requested by the regulations in this part. the sponsor, and authorization has (c) A regulation will not be issued al- been granted by the Food and Drug Ad- lowing the use of a food additive in a ministration in accordance with § 511.1 food for which a definition and stand- of this chapter or by the Department of ard of identity is established, unless its Agriculture in accordance with 9 CFR issuance is in conformity with section 309.17, and it bears a label which states 401 of the Act or with the terms of a prominently, in addition to the other temporary permit issued under § 130.17 information required by the Act, the of this chapter. When the contemplated warning: use of such additive complies with the Caution. Contains a new food additive for terms of a temporary permit, the food use only in investigational animals. Not for additive regulation will be conditioned use in humans. on such compliance and will expire Edible products of investigational animals with the expiration of the temporary are not to be used for food unless authoriza- permit. tion has been granted by the U.S. Food and Drug Administration or by the U.S. Depart- § 170.15 Adoption of regulation on ini- ment of Agriculture. tiative of Commissioner. (c) If intended for nonclinical labora- (a) The Commissioner upon his own tory studies in food-producing animals, initiative may propose the issuance of the study is conducted in compliance a regulation prescribing, with respect with the regulations set forth in part 58 to any particular use of a food additive, of this chapter. the conditions under which such additive may be safely used. Notice of such [42 FR 14483, Mar. 15, 1977, as amended at 43 FR 60021, Dec. 22, 1978] proposal shall be published in the FED- ERAL REGISTER and shall state the rea- § 170.18 Tolerances for related food ad- sons for the proposal. ditives. (b) Action upon a proposal made by (a) Food additives that cause similar the Commissioner shall proceed as pro- or related pharmacological effects will vided in part 10 of this chapter. be regarded as a class, and in the ab- [42 FR 14486, Mar. 15, 1977, as amended at 42 sence of evidence to the contrary, as FR 15673, Mar. 22, 1977] having additive toxic effects and will be considered as related food additives. § 170.17 Exemption for investigational (b) Tolerances established for such use and procedure for obtaining au- related food additives may limit the thorization to market edible products from experimental animals. amount of a common component that may be present, or may limit the A food additive or food containing a amount of biological activity (such as food additive intended for investiga- cholinesterase inhibition) that may be tional use by qualified experts shall be present or may limit the total amount exempt from the requirements of sec- of related food additives that may be tion 409 of the Act under the following present. conditions: (c) Where food additives from two or (a) If intended for investigational use more chemicals in the same class are in vitro or in laboratory research ani- present in or on a food, the tolerance mals, it bears a label which states for the total of such additives shall be prominently, in addition to the other the same as that for the additive hav- information required by the act, the ing the lowest numerical tolerance in warning: this class, unless there are available Caution. Contains a new food additive for methods that permit quantitative de- investigational use only in laboratory re- termination of the amount of each food search animals or for tests in vitro. Not for additive present or unless it is shown use in humans. that a higher tolerance is reasonably (b) If intended for use in animals required for the combined additives to other than laboratory research animals accomplish the physical or technical and if the edible products of the ani- effect for which such combined addi- mals are to be marketed as food, per- tives are intended and that the higher mission for the marketing of the edible tolerance will be safe.

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(d) Where residues from two or more mixing with other foods to reduce the additives in the same class are present residue in the mixed food below the tol- in or on a food and there are available erance prescribed for the raw agricul- methods that permit quantitative de- tural commodity. termination of each residue, the quantity of combined residues that are Subpart B—Food Additive Safety within the tolerance may be determined as follows: § 170.20 General principles for evalu- (1) Determine the quantity of each ating the safety of food additives. residue present. (a) In reaching a decision on any pe- (2) Divide the quantity of each res- tition filed under section 409 of the idue by the tolerance that would apply if it occurred alone, and multiply by Act, the Commissioner will give full 100 to determine the percentage of the consideration to the specific biological permitted amount of residue present. properties of the compound and the (3) Add the percentages so obtained adequacy of the methods employed to for all residues present. demonstrate safety for the proposed (4) The sum of the percentage shall use, and the Commissioner will be not exceed 100 percent. guided by the principles and procedures for establishing the safety of food addi- § 170.19 Pesticide chemicals in proc- tives stated in current publications of essed foods. the National Academy of Sciences-Na- When pesticide chemical residues tional Research Council. A petition occur in processed foods due to the use will not be denied, however, by reason of raw agricultural commodities that of the petitioner’s having followed pro- bore or contained a pesticide chemical cedures other than those outlined in in conformity with an exemption the publications of the National Acad- granted or a tolerance prescribed under emy of Sciences-National Research section 408 of the Act, the processed Council if, from available evidence, the food will not be regarded as adulter- Commissioner finds that the proce- ated so long as good manufacturing dures used give results as reliable as, practice has been followed in removing or more reliable than, those reasonably any residue from the raw agricultural to be expected from the use of the out- commodity in the processing (such as lined procedures. In reaching a deci- by peeling or washing) and so long as sion, the Commissioner will give due the concentration of the residue in the weight to the anticipated levels and processed food when ready to eat is not patterns of consumption of the additive greater than the tolerance prescribed specified or reasonably inferrable. For for the raw agricultural commodity. the purposes of this section, the prin- But when the concentration of residue ciples for evaluating safety of additives in the processed food when ready to eat set forth in the abovementioned publi- is higher than the tolerance prescribed cations will apply to any substance for the raw agricultural commodity, that may properly be classified as a the processed food is adulterated unless food additive as defined in section the higher concentration is permitted 201(s) of the Act. by a tolerance obtained under section (b) Upon written request describing 409 of the Act. For example, if fruit the proposed use of an additive and the bearing a residue of 7 parts per million proposed experiments to determine its of DDT permitted on the raw agricul- safety, the Commissioner will advise a tural commodity is dried and a residue person who wishes to establish the in excess of 7 parts per million of DDT safety of a food additive whether he be- results on the dried fruit, the dehy- lieves the experiments planned will drated fruit is adulterated unless the yield data adequate for an evaluation higher tolerance for DDT is authorized of the safety of the additive. by the regulations in this part. Food that is itself ready to eat, and which § 170.22 Safety factors to be consid- contains a higher residue than allowed ered. for the raw agricultural commodity, In accordance with section may not be legalized by blending or 409(c)(5)(C) of the Act, the following

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safety factors will be applied in deter- achieve general recognition of safety mining whether the proposed use of a only through scientific procedures. food additive will be safe: Except where (2) A substance used in food prior to evidence is submitted which justifies January 1, 1958, may be generally rec- use of a different safety factor, a safety ognized as safe through experience factor in applying animal experimen- based on its common use in food when tation data to man of 100 to 1, will be that use occurred exclusively or pri- used; that is, a food additive for use by marily outside of the United States if man will not be granted a tolerance the information about the experience that will exceed 1⁄100th of the maximum establishes that the use of the sub- amount demonstrated to be without stance is safe within the meaning of harm to experimental animals. the act (see § 170.3(i)). Common use in food prior to January 1, 1958, that oc- § 170.30 Eligibility for classification as curred outside of the United States generally recognized as safe shall be documented by published or (GRAS). other information and shall be corrobo- (a) General recognition of safety may rated by information from a second, be based only on the views of experts independent source that confirms the qualified by scientific training and ex- history and circumstances of use of the perience to evaluate the safety of sub- substance. The information used to stances directly or indirectly added to document and to corroborate the his- food. The basis of such views may be ei- tory and circumstances of use of the ther (1) scientific procedures or (2) in substance must be generally available; the case of a substance used in food that is, it must be widely available in prior to January 1, 1958, through expe- the country in which the history of use rience based on common use in food. has occurred and readily available to General recognition of safety requires interested qualified experts in this common knowledge about the sub- country. Persons claiming GRAS sta- stance throughout the scientific com- tus for a substance based on its community knowledgeable about the safety mon use in food outside of the United of substances directly or indirectly States should obtain FDA concurrence added to food. that the use of the substance is GRAS. (b) General recognition of safety (d) The food ingredients listed as based upon scientific procedures shall GRAS in part 182 of this chapter or af- require the same quantity and quality firmed as GRAS in part 184 or § 186.1 of of scientific evidence as is required to this chapter do not include all sub- obtain approval of a food additive regu- stances that are generally recognized lation for the ingredient. General rec- as safe for their intended use in food. ognition of safety through scientific Because of the large number of sub- procedures shall ordinarily be based stances the intended use of which re- upon published studies which may be sults or may reasonably be expected to corroborated by unpublished studies result, directly or indirectly, in their and other data and information. becoming a component or otherwise af- (c)(1) General recognition of safety fecting the characteristics of food, it is through experience based on common impracticable to list all such sub- use in food prior to January 1, 1958, stances that are GRAS. A food ingre- may be determined without the quan- dient of natural biological origin that tity or quality of scientific procedures has been widely consumed for its nutri- required for approval of a food additive ent properties in the United States regulation. General recognition of safe- prior to January 1, 1958, without known ty through experience based on com- detrimental effects, which is subject mon use in food prior to January 1, only to conventional processing as 1958, shall be based solely on food use practiced prior to January 1, 1958, and of the substance prior to January 1, for which no known safety hazard ex- 1958, and shall ordinarily be based upon ists, will ordinarily be regarded as generally available data and informa- GRAS without specific inclusion in tion. An ingredient not in common use part 182, part 184 or § 186.1 of this chap- in food prior to January 1, 1958, may ter.

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(e) Food ingredients were listed as (6) Substances of natural biological GRAS in part 182 of this chapter during origin intended for consumption for 1958–1962 without a detailed scientific other than their nutrient properties. review of all available data and infor- (g) A food ingredient that is not mation relating to their safety. Begin- GRAS or subject to a prior sanction re- ning in 1969, the Food and Drug Admin- quires a food additive regulation pro- istration has undertaken a systematic mulgated under section 409 of the act review of the status of all ingredients before it may be directly or indirectly used in food on the determination that added to food. they are GRAS or subject to a prior (h) A food ingredient that is listed as sanction. All determinations of GRAS GRAS in part 182 of this chapter or af- status or food additive status or prior firmed as GRAS in part 184 or § 186.1 of sanction status pursuant to this review this chapter shall be regarded as GRAS shall be handled pursuant to §§ 170.35, only if, in addition to all the requirements in the applicable regulation, it 170.38, and 180.1 of this chapter. Affir- also meets all of the following require- mation of GRAS status shall be an- ments: nounced in part 184 or § 186.1 of this (1) It complies with any applicable chapter. food grade specifications of the Food (f) The status of the following food Chemicals Codex, 2d Ed. (1972), or, if ingredients will be reviewed and af- specifically indicated in the GRAS affirmed as GRAS or determined to be a firmation regulation, the Food Chemi- food additive or subject to a prior sanc- cals Codex, 3d Ed. (1981), which are in- tion pursuant to § 170.35, § 170.38, or corporated by reference, except that § 180.1 of this chapter: any substance used as a component of (1) Any substance of natural biologi- articles that contact food and affirmed cal origin that has been widely con- as GRAS in § 186.1 of this chapter shall sumed for its nutrient properties in the comply with the specifications therein, United States prior to January 1, 1958, or in the absence of such specifications, without known detrimental effect, for shall be of a purity suitable for its in- which no health hazard is known, and tended use. Copies may be obtained which has been modified by processes from the National Academy Press, 2101 first introduced into commercial use Constitution Ave. NW., Washington, after January 1, 1958, which may rea- DC 20418, or may be examined at the sonably be expected significantly to Office of the Federal Register, 800 alter the composition of the substance. North Capitol Street, NW., suite 700, (2) Any substance of natural biologi- Washington, DC 20408. cal origin that has been widely con- (2) It performs an appropriate func- sumed for its nutrient properties in the tion in the food or food-contact article United States prior to January 1, 1958, in which it is used. without known detrimental effect, for (3) It is used at a level no higher than necessary to achieve its intended pur- which no health hazard is known, that pose in that food or, if used as a compo- has had significant alteration of com- nent of a food-contact article, at a position by breeding or selection after level no higher than necessary to January 1, 1958, where the change may achieve its intended purpose in that ar- be reasonably expected to alter the nu- ticle. tritive value or the concentration of (i) If a substance is affirmed as GRAS toxic constituents. in part 184 or § 186.1 of this chapter with (3) Distillates, isolates, extracts, and no limitation other than good manu- concentration of extracts of GRAS sub- facturing practice, it shall be regarded stances. as GRAS if its conditions of use are not (4) Reaction products of GRAS sub- significantly different from those re- stances. ported in the regulation as the basis on (5) Substances not of a natural bio- which the GRAS status of the sub- logical origin, including those for stance was affirmed. If the conditions which evidence is offered that they are of use are significantly different, such identical to a GRAS counterpart of use of the substance may not be GRAS. natural biological origin. In such a case a manufacturer may not

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rely on the regulation as authorizing data and information and/or file com- the use but must independently estab- ments with the Division of Dockets lish that the use is GRAS or must use Management. Copies of all comments the substance in accordance with a received shall be made available for ex- food additive regulation. amination in the Division of Dockets (j) If an ingredient is affirmed as Management’s office. GRAS in part 184 or § 186.1 of this chap- (3) The Commissioner will evaluate ter with specific limitation(s), it may all comments received. If he concludes be used in food only within such limi- that there is convincing evidence that tation(s) (including the category of the substance is GRAS as described in food(s), the functional use(s) of the in- § 170.30, he will publish a notice in the gredient, and the level(s) of use). Any FEDERAL REGISTER listing the sub- use of such an ingredient not in full stance as GRAS in part 182, part 184, or compliance with each such established part 186 of this chapter, as appropriate. limitation shall require a food additive (4) If, after evaluation of the com- regulation. ments, the Commissioner concludes (k) Pursuant to § 170.35, a food ingre- that there is a lack of convincing evi- dient may be affirmed as GRAS in part dence that the substance is GRAS and 184 or § 186.1 of this chapter for a spe- that it should be considered a food ad- cific use(s) without a general evalua- ditive subject to section 409 of the Act, tion of use of the ingredient. In addi- he shall publish a notice thereof in the tion to the use(s) specified in the regu- FEDERAL REGISTER in accordance with lation, other uses of such an ingredient § 170.38. may also be GRAS. Any affirmation of (c)(1) Persons seeking the affirmation GRAS status for a specific use(s), with- of GRAS status of substances as pro- out a general evaluation of use of the vided in § 170.30(e), except those subject ingredient, is subject to reconsider- to the NAS/NRC GRAS list survey (36 ation upon such evaluation. FR 20546; October 23, 1971), shall submit (l) New information may at any time a petition for GRAS affirmation pursu- require reconsideration of the GRAS ant to part 10 of this chapter. Such pe- status of a food ingredient. Any change tition shall contain information to es- in part 182, part 184, or § 186.1 of this tablish that the GRAS criteria as set chapter shall be accomplished pursuant forth in § 170.30 (b) or (c) have been met, to § 170.38. in the following form: [42 FR 14483, Mar. 15, 1977, as amended at 49 (i) Description of the substance, in- FR 5610, Feb. 14, 1984; 53 FR 16546, May 10, cluding: 1988] (a) Common or usual name. (b) Chemical name. § 170.35 Affirmation of generally recognized as safe (GRAS) status. (c) Chemical Abstract Service (CAS) registry number. (a) The Commissioner, either on his (d) Empirical formula. initiative or on the petition of an interested person, may affirm the GRAS (e) Structural formula. status of substances that directly or (f) Specifications for food grade ma- indirectly become components of food. terial, including arsenic and heavy (b)(1) If the Commissioner proposes metals. (Recommendation for any on his own initiative that a substance change in the Food Chemicals Codex is entitled to affirmation as GRAS, he monograph should be included where will place all of the data and informa- applicable.) tion on which he relies on public file in (g) Quantitative compositions. the office of the Division of Dockets (h) Manufacturing process (excluding Management and will publish in the any trade secrets). FEDERAL REGISTER a notice giving the (ii) Use of the substance, including: name of the substance, its proposed (a) Date when use began. uses, and any limitations proposed for (b) Information and reports or other purposes other than safety. data on past uses in food. (2) The FEDERAL REGISTER notice will (c) Foods in which used, and levels of allow a period of 60 days during which use in such foods, and for what pur- any interested person may review the poses.

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(iii) Methods for detecting the sub- petitioner at the time the original is stance in food, including: sent to the FEDERAL REGISTER. (a) References to qualitative and (3)(i) If intended uses of the sub- quantitative methods for determining stance include uses in meat, meat food the substance(s) in food, including the product, or poultry product subject to type of analytical procedures used. regulation by the U.S. Department of (b) Sensitivity and reproducibility of Agriculture (USDA) under the Poultry such method(s). Products Inspection Act (PPIA) (21 (iv) Information to establish the safe- U.S.C. 451 et seq.) or Federal Meat In- ty and functionality of the substance spection Act (FMIA) (21 U.S.C. 601 et in food. Published scientific literature, seq.), FDA shall, upon filing of the peti- evidence that the substance is identical tion, forward a copy of the petition or to a GRAS counterpart of natural bio- relevant portions thereof to the Food logical origin, and other data may be Safety and Inspection Service, USDA, submitted to support safety. Any ad- for simultaneous review under the verse information or consumer com- PPIA and FMIA. plaints shall be included. Complete bib- (ii) FDA will ask USDA to advise liographic references shall be provided whether the proposed meat and poultry where a copy of the article is not pro- uses comply with the FMIA and PPIA or, if not, whether use of the substance vided. would be permitted in products under (v) A statement signed by the person USDA jurisdiction under specified con- responsible for the petition that to the ditions or restrictions. best of his knowledge it is a represent- (4) The notice of filing in the FED- ative and balanced submission that in- ERAL REGISTER will allow a period of 60 cludes unfavorable information, as well days during which any interested per- as favorable information, known to son may review the petition and/or file him pertinent to the evaluation of the comments with the Division of Dockets safety and functionality of the sub- Management. Copies of all comments stance. received shall be made available for ex- (vi) If nonclinical laboratory studies amination in the Division of Dockets are involved, additional information Management’s office. and data submitted in support of filed (5) The Commissioner will evaluate petitions shall include, with respect to the petition and all available informa- each nonclinical study, either a state- tion including all comments received. ment that the study was conducted in If the petition and such information compliance with the requirements set provide convincing evidence that the forth in part 58 of this chapter, or, if substance is GRAS as described in the study was not conducted in compli- § 170.30 he will publish an order in the ance with such regulations, a brief FEDERAL REGISTER listing the sub- statement of the reason for the non- stance as GRAS in part 182, part 184, or compliance. part 186 of this chapter, as appropriate. (vii) [Reserved] (6) If, after evaluation of the petition (viii) A claim for categorical exclu- and all available information, the Com- sion under § 25.30 or § 25.32 of this chap- missioner concludes that there is a ter or an environmental assessment lack of convincing evidence that the under § 25.40 of this chapter. substance is GRAS and that it should (2) Within 30 days after the date of be considered a food additive subject to filing the petition, the Commissioner section 409 of the Act, he shall publish will place the petition on public file in a notice thereof in the FEDERAL REG- the office of the Division of Dockets ISTER in accordance with § 170.38. Management and will publish a notice (7) The notice of filing in the FED- of filing in the FEDERAL REGISTER giv- ERAL REGISTER will request submission ing the name of the petitioner and a of proof of any applicable prior sanc- brief description of the petition includ- tion for use of the ingredient under ing the name of the substance, its pro- conditions different from those proposed use, and any limitations proposed to be determined to be GRAS. posed for reasons other than safety. A The failure of any person to come for- copy of the notice will be mailed to the ward with proof of such an applicable

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prior sanction in response to the notice otherwise exempt from the definition of filing will constitute a waiver of the of a food additive in section 201(s) of right to assert or rely on such sanction the Act, he will publish a notice there- at any later time. The notice of filing of in the FEDERAL REGISTER. If he con- will also constitute a proposal to estab- cludes that there is convincing evi- lish a regulation under part 181 of this dence that the substance is GRAS, he chapter, incorporating the same provi- will publish an order in the FEDERAL sions, in the event that such a regula- REGISTER listing the substance as tion is determined to be appropriate as GRAS in part 182, part 184, or part 186 a result of submission of proof of such of this chapter, as appropriate. an applicable prior sanction in response to the notice of filing. (c) A FEDERAL REGISTER notice determining that a substance is a food addi- (Information collection requirements were tive shall provide for the use of the ad- approved by the Office of Management and ditive in food or food contact surfaces Budget under control number 0910–0132) as follows: [42 FR 14488, Mar. 15, 1977, as amended at 50 (1) It may promulgate a food additive FR 7492, Feb. 22, 1985; 50 FR 16668, Apr. 26, regulation governing use of the addi- 1985; 53 FR 16547, May 10, 1988; 62 FR 40599, July 29, 1997; 65 FR 51762, Aug. 25, 2000] tive. (2) It may promulgate an interim § 170.38 Determination of food addi- food additive regulation governing use tive status. of the additive. (a) The Commissioner may, in ac- (3) It may require discontinuation of cordance with § 170.35(b)(4) or (c)(5), the use of the additive. publish a notice in the FEDERAL REG- (4) It may adopt any combination of ISTER determining that a substance is the above three approaches for dif- not GRAS and is a food additive sub- ferent uses or levels of use of the addi- ject to section 409 of the Act. tive. (b)(1) The Commissioner, on his own (d) If the Commissioner of Food and initiative or on the petition of any in- Drugs is aware of any prior sanction terested person, pursuant to part 10 of for use of the substance, he will con- this chapter, may issue a notice in the currently propose a separate regulation FEDERAL REGISTER proposing to determine that a substance is not GRAS and covering such use of the ingredient is a food additive subject to section 409 under part 181 of this chapter. If the of the Act. Any petition shall include Commissioner is unaware of any such all relevant data and information of applicable prior sanction, the proposed the type described in § 171.130(b). The regulation will so state and will re- Commissioner will place all of the data quire any person who intends to assert and information on which he relies on or rely on such sanction to submit public file in the office of the Division proof of its existence. Any regulation of Dockets Management and will in- promulgated pursuant to this section clude in the FEDERAL REGISTER notice constitutes a determination that ex- the name of the substance, its known cluded uses would result in adultera- uses, and a summary of the basis for tion of the food in violation of section the determination. 402 of the Act, and the failure of any (2) The FEDERAL REGISTER notice will person to come forward with proof of allow a period of 60 days during which such an applicable prior sanction in re- any interested person may review the sponse to the proposal will constitute a data and information and/or file com- waiver of the right to assert or rely on ments with the Division of Dockets such sanction at any later time. The Management. Copies of all comments notice will also constitute a proposal shall be made available for examina- to establish a regulation under part 181 tion in the Division of Dockets Man- of this chapter, incorporating the same agement’s office. (3) The Commissioner will evaluate provisions, in the event that such a all comments received. If he concludes regulation is determined to be appro- that there is a lack of convincing evi- priate as a result of submission of proof dence that the substance is GRAS or is

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of such an applicable prior sanction in the Food and Drug Administration’s response to the proposal. files or from other appropriate sources; [42 FR 14488, Mar. 15, 1977, as amended at 42 (3) The substance has no technical ef- FR 15673, Mar. 22, 1977; 54 FR 24896, June 12, fect in or on the food to which it mi- 1989] grates; and (4) The substance use has no signifi- § 170.39 Threshold of regulation for cant adverse impact on the environ- substances used in food-contact articles. ment. (b) Notwithstanding paragraph (a) of (a) A substance used in a food-con- this section, the Food and Drug Admin- tact article (e.g., food-packaging or istration reserves the right to decline food-processing equipment) that mi- to grant an exemption in those cases in grates, or that may be expected to mi- which available information estab- grate, into food will be exempted from regulation as a food additive because it lishes that the proposed use may pose a becomes a component of food at levels public health risk. The reasons for the that are below the threshold of regula- agency’s decision to decline to grant an tion if: exemption will be explained in the (1) The substance has not been shown Food and Drug Administration’s re- to be a carcinogen in humans or ani- sponse to the requestor. mals, and there is no reason, based on (c) A request for the Food and Drug the chemical structure of the sub- Administration to exempt a use of a stance, to suspect that the substance is substance from regulation as a food ad- a carcinogen. The substance must also ditive shall include three copies of the not contain a carcinogenic impurity or, following information (If part of the if it does, must not contain a carcino- submitted material is in a foreign lan- genic impurity with a TD50 value based guage, it must be accompanied by an on chronic feeding studies reported in English translation verified to be com- the scientific literature or otherwise plete and accurate in accordance with available to the Food and Drug Admin- § 10.20(c)(2) of this chapter): istration of less than 6.25 milligrams (1) The chemical composition of the per kilogram bodyweight per day (The substance for which the request is TD50, for the purposes of this section, is made, including, whenever possible, the feeding dose that causes cancer in the name of the chemical in accord- 50 percent of the test animals when ance with current Chemical Abstract corrected for tumors found in control Service (CAS) nomenclature guidelines animals. If more than one TD50 value and a CAS registry number, if avail- has been reported in the scientific lit- able; erature for a substance, the Food and (2) Detailed information on the con- Drug Administration will use the low- ditions of use of the substance (e.g., est appropriate TD50 value in its re- temperature, type of food with which view.); the substance will come into contact, (2) The substance presents no other the duration of the contact, and wheth- health or safety concerns because: er the food-contact article will be for (i) The use in question has been shown to result in or may be expected repeated or single use applications); to result in dietary concentrations at (3) A clear statement as to whether or below 0.5 parts per billion, cor- the request for exemption from regula- responding to dietary exposure levels tion as a food additive is based on the at or below 1.5 micrograms/person/day fact that the use of the substance in (based on a diet of 1,500 grams of solid the food-contact article results in a di- food and 1,500 grams of liquid food per etary concentration at or below 0.5 person per day); or parts per billion, or on the fact that it (ii) The substance is currently regu- involves the use of a regulated direct lated for direct addition into food, and food additive for which the dietary ex- the dietary exposure to the substance posure is at or below 1 percent of the resulting from the proposed use is at or acceptable dietary intake (ADI); below 1 percent of the acceptable daily (4) Data that will enable the Food intake as determined by safety data in and Drug Administration to estimate

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the daily dietary concentration result- posed use of the substance. The request ing from the proposed use of the sub- should contain either a claim for cat- stance. These data should be in the egorical exclusion as specified in § 25.32 form of: of this chapter or an environmental as- (i) Validated migration data obtained sessment as specified in § 25.40 of this under worst-case (time/temperature) chapter. intended use conditions utilizing ap- (d) Data to be reviewed under this propriate food simulating solvents; section shall be submitted to the Food (ii) Information on the amount of the and Drug Administration’s Office of substance used in the manufacture of Premarket Approval (HFS–200), 5100 the food-contact article; or Paint Branch Pkwy., College Park, MD (iii) Information on the residual level 20740. of the substance in the food-contact ar- (e) The Food and Drug Administra- ticle. For repeat-use articles, an esti- tion will inform the requestor by letter mate of the amount of food that con- whether the specific food-contact ap- tacts a specific unit of surface area plication is exempt from regulation as over the lifetime of the article should a food additive or not. Although a sub- also be provided. (In cases where data stance that migrates to food at a level are provided only in the form of manu- that results in a dietary concentration facturing use levels or residual levels at or below the threshold of regulation of the substance present in the food- contact article, the Food and Drug Ad- will not be the subject of a regulation ministration will calculate a worst- published in the FEDERAL REGISTER case dietary concentration level as- and will not appear in the Code of Fed- suming 100 percent migration.) A de- eral Regulations, the Food and Drug tailed description of the analytical Administration will maintain a list of method used to quantify the substance substances exempted from regulation should also be submitted along with as food additives under this section on data used to validate the detection display at the Division of Dockets limit. Management. This list will include the (iv) In cases where there is no detect- name of the company that made the re- able migration into food or food quest, the chemical name of the sub- simulants, or when no residual level of stance, the specific use for which it has a substance is detected in the food-con- received an exemption from regulation tact article by a suitable analytical as a food additive, and any appropriate method, the Food and Drug Adminis- limitations on its use. The list will not tration will, for the purposes of esti- include any trade names. This list will mating the dietary concentration, con- enable interested persons to see the sider the validated detection limit of types of uses of food-contact materials the method used to analyze for the sub- being exempted under the regulation. stance. Interested persons may also obtain a (5) The results of an analysis of exist- copy of the list of exempted substances ing toxicological information on the by contacting the Food and Drug Ad- substance and its impurities. This in- ministration’s Office of Premarket Ap- formation on the substance is needed proval (HFS–200), 5100 Paint Branch to show whether an animal carcinogen Pkwy., College Park, MD 20740. For ac- bioassay has been carried out, or tions requiring an environmental as- whether there is some other basis for sessment, the agency’s finding of no suspecting that the substance is a car- significant impact and the evidence cinogen or potent toxin. This type of supporting that finding, contained in information on the impurities is need- the petitioner’s environmental assess- ed to show whether any of them are ment, also will be available for public carcinogenic, and, if carcinogenic, inspection at the Division of Dockets whether their TD50 values are greater Management in accordance with than 6.25 milligrams per kilogram § 25.51(b)(2) of this chapter. Requests for bodyweight per day in accordance with copies of releasable information con- paragraph (a)(1) of this section. tained in submissions requesting ex- (6) Information on the environmental emptions from the food additive regu- impact that would result from the pro- lations will be handled in accordance

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with the Food and Drug Administra- and Drug Administration plans to no- tion’s Freedom of Information Act pro- tify other manufacturers by means of a cedures, as described in part 20 of this notice published in the FEDERAL REG- chapter. In particular, data and infor- ISTER of its decision to revoke an ex- mation that fall within the definitions emption issued for a specific use of a of a trade secret or confidential com- substance in a food contact article. mercial or financial information are (h) Guidance documents to assist re- not available for public disclosure in questors in the preparation of submis- accordance with § 20.61(c) of this chap- sions seeking exemptions from the food ter. additive regulations are available from (f) If the request for an exemption the Food and Drug Administration’s from regulation as a food additive is Office of Premarket Approval (HFS– not granted, the requestor may submit 200), 5100 Paint Branch Pkwy., College a petition to the Food and Drug Ad- Park, MD 20740. Interested persons are ministration for reconsideration of the encouraged to obtain specific guidance decision in accordance with the provi- from the Food and Drug Administra- sions of § 10.33 of this chapter. tion on the appropriate protocols to be (g) If the Food and Drug Administra- used for obtaining migration data, on tion receives significant new informa- the validation of the analytical meth- tion that raises questions about the di- ods used to quantify migration levels, etary concentration or the safety of a on the procedures used to relate migra- substance that the agency has exempt- tion data to dietary exposures, and on ed from regulation, the Food and Drug any other issue not specifically covered Administration may reevaluate the in the Food and Drug Administration’s substance. If the Food and Drug Ad- guidance documents. ministration tentatively concludes [60 FR 36595, July 17, 1995, as amended at 62 that the information that is available FR 40599, July 29, 1997; 65 FR 56479, Sept. 19, about the substance no longer supports 2000] an exemption for the use of the food- contact material from the food addi- Subpart C—Specific Administra- tive regulations, the agency will notify tive Rulings and Decisions any persons that requested an exemption for the substance of its tentative § 170.45 Fluorine-containing com- decision. The requestors will be given pounds. an opportunity to show why the use of The Commissioner of Food and Drugs the substance should not be regulated has concluded that it is in the interest under the food additive provisions of of the public health to limit the addi- the act. If the requestors fail to ade- tion of fluorine compounds to foods (a) quately respond to the new evidence, to that resulting from the fluoridation the agency will notify them that fur- of public water supplies as stated in ther use of the substance in question § 250.203 of this chapter, (b) to that re- for the particular use will require a sulting from the fluoridation of bottled food additive regulation. This notifica- water within the limitation established tion will be placed on public display at in § 103.35(d) of this chapter, and (c) to the Division of Dockets Management that authorized by regulations (40 CFR as part of the file of uses of substances part 180) under section 408 of the Act. exempted from regulation as food additives. The Food and Drug Administra- § 170.50 Glycine (aminoacetic acid) in tion recognizes that manufacturers food for human consumption. other than those that actually made a (a) Heretofore, the Food and Drug request for exemption may also be Administration has expressed the opin- using exempted substances in food-con- ion in trade correspondence that gly- tact articles under conditions of use cine is generally recognized as safe for (e.g., use levels, temperature, type of certain technical effects in human food food contacted, etc.) that are similar to when used in accordance with good those for which the exemption was manufacturing practice; however: issued. Because only requestors will be (1) Reports in scientific literature in- notified as part of the revocation proc- dicate that adverse effects were found ess described in this section, the Food in cases where high levels of glycine

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were administered in diets of experi- (b) Nitrites and/or nitrates, when mental animals. packaged separately from flavoring (2) Current usage information indi- and seasoning in curing premixes, may cates that the daily dietary intake of continue to be used under prior sanc- glycine by humans may be substan- tions in the commercial curing of meat tially increasing due to changing use and meat products and poultry prod- patterns in food technology. ucts and in accordance with the provi- Therefore, the Food and Drug Adminis- sions of §§ 172.170 and 172.175 of this tration no longer regards glycine and chapter that apply to meat curing its salts as generally recognized as safe preparations for the home curing of for use in human food and all out- meat and meat products, including standing letters expressing sanction for poultry and wild game. To assure safe such use are rescinded. use of such ingredients the labeling of (b) The Commissioner of Food and the premixes shall bear instructions to Drugs concludes that by May 8, 1971, the user that such separately packaged manufacturers: ingredients are not to be combined (1) Shall reformulate food products until just prior to use. Encapsulating for human use to eliminate added gly- or coating some or all of the ingredi- cine and its salts; or ents does not constitute separate pack- (2) Shall bring such products into aging. compliance with an authorizing food additive regulation. A food additive pe- Subpart D—Premarket tition supported by toxicity data is re- Notifications quired to show that any proposed level of glycine or its salts added to foods for SOURCE: 67 FR 35729, May 21, 2002, unless human consumption will be safe. otherwise noted. (c) The status of glycine as generally recognized as safe for use in animal § 170.100 Submission of a premarket feed, as prescribed in § 582.5049 of this notification for a food contact subchapter, remains unchanged because stance (FCN) to the Food and Drug the additive is considered an essential Administration (FDA). nutrient in certain animal feeds and is (a) An FCN is effective for the food safe for such use under conditions of contact substance manufactured or good feeding practice. prepared by the manufacturer or supplier identified in the FCN submission. § 170.60 Nitrites and/or nitrates in curing premixes. If another manufacturer or supplier wishes to market the same food con- (a) Nitrites and/or nitrates are food tact substance for the same use, that additives when combined in curing pre- manufacturer or supplier must also mixes with spices and/or other fla- submit an FCN to FDA. voring or seasoning ingredients that (1) An FCN must contain all of the contain or constitute a source of sec- information described in § 170.101. ondary or tertiary amines, including (2) An FCN may incorporate by ref- but not limited to essential oils, disodium inosinate, disodium guanylate, erence any information in FDA’s files hydrolysates of animal or plant origin provided that the manufacturer or sup- (such as hydrolyzed vegetable protein), plier is authorized to reference the in- oleoresins of spices, soy products, and formation. The FCN must include in- spice extractives. Such food additives formation establishing that the manu- may be used only after the establish- facturer or supplier is authorized to ment of an authorizing food additive reference information in FDA’s files. regulation. A food additive petition (3) Any material submitted in or ref- submitted pursuant to §§ 171.1 and erenced by an FCN that is in a foreign 171.100 of this chapter, supported by language must be accompanied by an data demonstrating that nitrosamines English translation verified to be com- are not formed in curing premixes con- plete and accurate. taining such food additives, is required (b) FDA may choose not to accept an to establish safety. FCN for either of the following:

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(1) A use of a food contact substance (b) All data and other information that is the subject of a regulation in that form the basis of the determina- parts 173 through 189 of this chapter; or tion that the food contact substance is (2) A use of a food contact substance safe under the intended conditions of that is the subject of an exemption use. Data must include primary bio- under the threshold of regulation proc- logical data and chemical data. ess described in § 170.39. (c) A good laboratory practice state- (c) A petition must be submitted ment for each nonclinical laboratory under § 171.1 of this chapter to author- study, as defined under § 58.3(d) of this ize the safe use of a food contact subchapter, that is submitted as part of stance in either of the following cir- the FCN, in the form of either: cumstances, unless FDA agrees to ac- (1) A signed statement that the study cept an FCN for the proposed use. was conducted in compliance with the (1) The use of the food contact sub- good laboratory practice regulations stance increases the cumulative die- under part 58 of this chapter; or tary concentration to a certain level. (2) A brief signed statement listing For a substance that is a biocide (e.g., the reason(s) that the study was not it is intended to exert microbial tox- conducted in compliance with part 58 icity), this level is equal to or greater of this chapter. than 200 parts per billion in the daily (3) Data from any study conducted diet (0.6 milligram (mg)/person/day). after 1978 but not conducted in compli- For a substance that is not a biocide, ance with part 58 of this chapter must this level is equal to or greater than 1 be validated by an independent third part per million in the daily diet (3 mg/ party prior to submission to the Food person/day); or and Drug Administration (FDA), and (2) There exists a bioassay on the the report and signed certification of food contact substance, FDA has not the validating party must be submitted reviewed the bioassay, and the bio- as part of the notification. assay is not clearly negative for car- (d) Information to address FDA’s re- cinogenic effects. sponsibility under the National Envi- (d) A manufacturer or supplier for ronmental Policy Act, in the form of which a notification is effective must either: keep a current address on file with (1) A claim of categorical exclusion FDA. under § 25.30 or § 25.32 of this chapter; or (1) The current address may be either (2) An environmental assessment the manufacturer’s (or supplier’s) ad- complying with § 25.40 of this chapter. dress or the address of the manufactur- (e) A completed and signed FDA er’s (or supplier’s) agent. Form No. 3480. (2) FDA will deliver correspondence to the manufacturer’s or supplier’s cur- § 170.102 Confidentiality of informa- rent address. tion in a premarket notification for a food contact substance (FCN). § 170.101 Information in a premarket (a) During the 120-day period of the notification for a food contact sub- Food and Drug Administration (FDA) stance (FCN). review of an FCN, FDA will not dis- An FCN must contain the following: close publicly any information in that (a) A comprehensive discussion of the FCN. basis for the manufacturer’s or sup- (b) FDA will not disclose publicly the plier’s determination that the use of information in an FCN that is with- the food contact substance is safe. This drawn prior to the completion of FDA’s discussion must: review. (1) Discuss all information and data (c) Once FDA completes its review of submitted in the notification; and an FCN, the agency will make its con- (2) Address any information and data clusion about the FCN publicly avail- that may appear to be inconsistent able. For example, if FDA objects to a with the determination that the pro- notification 90 days after the date of posed use of the food contact substance receipt, the agency would make avail- is safe. able its objection at that time.

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(d) By submitting an FCN to FDA, ing to the FCN or FDA has issued an the manufacturer or supplier waives objection letter. any claim to confidentiality of the information required to adequately de- § 170.104 Action on a premarket notifi- scribe the food contact substance and cation for a food contact substance (FCN). the intended conditions of use that are the subject of that FCN. (a) If the Food and Drug Administra- (e) The following data and information (FDA) does not object to an FCN tion in an FCN are available for public within the 120-day period for FDA re- disclosure, unless extraordinary cir- view, the FCN becomes effective. cumstances are shown, on the 121st day (b) If an FCN is complete when re- after receipt of the notification by ceived, the 120-day review period begins FDA, except that no data or informa- on the date FDA receives the FCN. tion are available for public disclosure (1) If any element required under if the FCN is withdrawn under § 170.103. § 170.101 is missing from an FCN, then (1) All safety and functionality data FDA will not accept that FCN and FDA and information submitted with or in- will send an FCN nonacceptance letter corporated by reference into the notifi- to the manufacturer or supplier. If the cation. Safety and functionality data manufacturer or supplier submits the include all studies and tests of a food missing information before FDA sends contact substance on animals and hu- an FCN nonacceptance letter, the 120- mans and all studies and tests on a day review period begins on the date of food contact substance for establishing receipt of the missing information. (2) If FDA accepts an FCN, then FDA identity, stability, purity, potency, will acknowledge in writing its receipt performance, and usefulness. of that FCN. (2) A protocol for a test or study, un- (c) Objection to an FCN: less it is exempt from disclosure under (1) If FDA objects to an FCN, then § 20.61 of this chapter. FDA will send an FCN objection letter. (3) A list of all ingredients contained The date of the letter will be the date in a food contact substance, excluding of FDA’s objection for purposes of sec- information that is exempt from dis- tion 409(h)(2)(A) of the act. closure under § 20.61 of this chapter. (2) If FDA objects to an FCN within Where applicable, an ingredient list the 120-day period for FDA review, the will be identified as incomplete. FCN will not become effective. (4) An assay method or other analyt- (3) FDA may object to an FCN if any ical method, unless it serves no regu- part of FDA’s 120-day review occurs latory or compliance purpose and is ex- during a period when this program is empt from disclosure under § 20.61 of not funded as required in section this chapter. 409(h)(5) of the act. (5) All correspondence and written (d) If FDA and a manufacturer or summaries of oral discussions relating supplier agree that the notifier may to the notification, except information submit a food additive petition pro- that is exempt for disclosure under posing the approval of the food contact § 20.61 of this chapter. substance for the use in the manufac- (6) All other information not subject turer’s or supplier’s FCN, FDA will to an exemption from disclosure under consider that FCN to be withdrawn by subpart D of part 20 of this chapter. the manufacturer or supplier on the date the petition is received by FDA. § 170.103 Withdrawal without prejudice of a premarket notification for § 170.105 The Food and Drug Adminis- a food contact substance (FCN). tration’s (FDA’s) determination that A manufacturer or supplier may a premarket notification for a food withdraw an FCN without prejudice to contact substance (FCN) is no a future submission to the Food and longer effective. Drug Administration (FDA) if FDA has (a) If data or other information avail- not completed review of the FCN. For able to FDA, including data not sub- the purpose of this section, FDA’s re- mitted by the manufacturer or sup- view is completed when FDA has al- plier, demonstrate that the intended lowed 120 days to pass without object- use of the food contact substance is no

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longer safe, FDA may determine that PART 171—FOOD ADDITIVE the authorizing FCN is no longer effec- PETITIONS tive. (b) If FDA determines that an FCN is Subpart A—General Provisions no longer effective, FDA will inform the manufacturer or supplier in writing Sec. of the basis for that determination. 171.1 Petitions. 171.6 Amendment of petition. FDA will give the manufacturer or sup- 171.7 Withdrawal of petition without preju- plier an opportunity to show why the dice. FCN should continue to be effective 171.8 Threshold of regulation for substances and will specify the time that the man- used in food-contact articles. ufacturer or supplier will have to respond. Subpart B—Administrative Actions on Applications (c) If the manufacturer or supplier fails to respond adequately to the safe- 171.100 Regulation based on petition. ty concerns regarding the notified use, 171.102 Effective date of regulation. FDA will publish a notice of its deter- 171.110 Procedure for objections and hear- mination that the FCN is no longer ef- ings. 171.130 Procedure for amending and repeal- fective. FDA will publish this notice in ing tolerances or exemptions from toler- the FEDERAL REGISTER, stating that a ances. detailed summary of the basis for AUTHORITY: 21 U.S.C. 321, 342, 348, 371. FDA’s determination that the FCN is no longer effective has been placed on SOURCE: 42 FR 14489, Mar. 15, 1977, unless otherwise noted. public display and that copies are available upon request. The date that the notice publishes in the FEDERAL Subpart A—General Provisions REGISTER is the date on which the noti- § 171.1 Petitions. fication is no longer effective. (d) FDA’s determination that an FCN (a) Petitions to be filed with the is no longer effective is final agency Commissioner under the provisions of section 409(b) of the Federal Food, action subject to judicial review. Drug, and Cosmetic Act (the act) shall § 170.106 Notification for a food con- be submitted in triplicate (quadru- tact substance formulation plicate, if intended uses include use in (NFCSF). meat, meat food product, or poultry product). If any part of the material (a) In order for the Food and Drug submitted is in a foreign language, it Administration (FDA) to accept an shall be accompanied by an accurate NFCSF, any food additive that is a and complete English translation. The component of the formulation must be petition shall state petitioner’s post of- authorized for its intended use in that fice address to which published notices NFCSF. or orders issued or objections filed pur- (b) FDA may publish a notice in the suant to section 409 of the Act may be FEDERAL REGISTER stating that the sent. agency has insufficient resources to re- (b) Pertinent information may be in- view NFCSFs. From the date that this corporated in, and will be considered as notice publishes in the FEDERAL REG- part of, a petition on the basis of spe- ISTER, FDA will no longer accept cific reference to such information sub- NFCSFs. mitted to and retained in the files of (c) An NFCSF must contain the fol- the Food and Drug Administration. lowing: However, any reference to unpublished (1) A completed and signed FDA information furnished by a person other than the applicant will not be Form No. 3479; and considered unless use of such informa- (2) Any additional documentation re- tion is authorized in a written state- quired to establish that each compo- ment signed by the person who sub- nent of the formulation already may be mitted it. Any reference to published marketed legally for its intended use. information offered in support of a food

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additive petition should be accom- be followed by a complete quantitative panied by reprints or photostatic cop- statement of composition. Reasonable alter- ies of such references. natives for any listed substance may be specified. (c) Petitions shall include the fol- If the petitioner does not himself perform lowing data and be submitted in the all the manufacturing, processing, and pack- following form: ing operations for a food additive, the petition shall identify each person who will per- (Date) form a part of such operations and designate Name of petitioner lllllllllllll the part. Post-office address lllllllllllll The petition shall include stability data, Date lllllllllllllllllllll and, if the data indicate that it is needed to Name of food additive and proposed use ll insure the identity, strength, quality, or pu- llllllllllllllllllllllll rity of the additive, the expiration date that Petitions Control Branch will be employed. Food and Drug Administration B. The amount of the food additive pro- Department of Health and Human Services posed for use and the purposes for which it is Washington, DC 20204. proposed, together with all directions, rec- ommendations, and suggestions regarding DEAR SIRS: the proposed use, as well as specimens of the The undersigned, lllll submits this labeling proposed for the food additive and petition pursuant to section 409(b)(1) of the any labeling that will be required by applica- Federal Food, Drug, and Cosmetic Act with ble provisions of the Federal Food, Drug, and respect to lllll Cosmetic Act on the finished food by reason (Name of the food additive and proposed use) of the use of the food additive. If the additive results or may reasonably be expected to re- Attached hereto, in triplicate (quadru- sult from the use of packaging material, the plicate, if intended uses include use in meat, petitioner shall show how this may occur meat food product, or poultry product), and and what residues may reasonably be antici- constituting a part of this petition are the pated. following: (Typewritten or other draft-labeling copy A. The name and all pertinent information will be accepted for consideration of the pe- concerning the food additive, including tition, provided a statement is made that chemical identity and composition of the final printed labeling identical in content to food additive, its physical, chemical, and bi- the draft copy will be submitted as soon as ological properties, and specifications pre- available and prior to the marketing of the scribing the minimum content of the desired food additive.) component(s) and identifying and limiting (If the food additive is one for which a tol- the reaction byproducts and other impuri- erance limitation is required to assure its ties. Where such information is not avail- safety, the level of use proposed should be no able, a statement as to the reasons why it is higher than the amount reasonably required not should be submitted. to accomplish the intended physical or other When the chemical identity and composi- technical effect, even though the safety data tion of the food additive is not known, the may support a higher tolerance.) petition shall contain information in suffi- C. Data establishing that the food additive cient detail to permit evaluation regarding will have the intended physical or other the method of manufacture and the analyt- technical effect or that it may reasonably be ical controls used during the various stages expected to become a component, or to affect of manufacturing, processing, or packing of the characteristics, directly or indirectly, of the food additive which are relied upon to es- food and the amount necessary to accom- tablish that it is a substance of reproducible plish this. These data should include infor- composition. Alternative methods and con- mation in sufficient detail to permit evalua- trols and variations in methods and controls tion with control data. within reasonable limits that do not affect D. A description of practicable methods to the characteristics of the substance or the determine the amount of the food additive in reliability of the controls may be specified. the raw, processed, and/or finished food and If the food additive is a mixture of chemi- of any substance formed in or on such food cals, the petition shall supply a list of all because of its use. The test proposed shall be substances used in the synthesis, extraction, one that can be used for food-control pur- or other method of preparation, regardless of poses and that can be applied with consistent whether they undergo chemical change in results by any properly equipped and trained the process. Each substance should be identi- laboratory personnel. fied by its common English name and com- E. Full reports of investigations made with plete chemical name, using structural for- respect to the safety of the food additive. mulas when necessary for specific identifica- (A petition may be regarded as incomplete tion. If any proprietary preparation is used unless it includes full reports of adequate as a component, the proprietary name should tests reasonably applicable to show whether

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or not the food additive will be safe for its tioner. Nothing herein shall prevent intended use. The reports ordinarily should reference to published data. include detailed data derived from appro- (g) A petition shall be retained but priate animal and other biological experi- shall not be filed if any of the data pre- ments in which the methods used and the results obtained are clearly set forth. The peti- scribed by section 409(b) of the Act are tion shall not omit without explanation any lacking or are not set forth so as to be reports of investigations that would bias an readily understood. evaluation of the safety of the food additive.) (h)(1) The following data and infor- F. Proposed tolerances for the food addi- mation in a food additive petition are tive, if tolerances are required in order to in- available for public disclosure, unless sure its safety. A petitioner may include a extraordinary circumstances are proposed regulation. shown, after the notice of filing of the G. If submitting petition to modify an existing regulation issued pursuant to section petition is published in the FEDERAL 409(c)(1)(A) of the Act, full information on REGISTER or, if the petition is not each proposed change that is to be made in promptly filed because of deficiencies the original regulation must be submitted. in it, after the petitioner is informed The petition may omit statements made in that it will not be filed because of the the original petition concerning which no deficiencies involved: change is proposed. A supplemental petition (i) All safety and functionality data must be submitted for any change beyond and information submitted with or in- the variations provided for in the original petition and the regulation issued on the corporated by reference in the petition. basis of the original petition. (ii) A protocol for a test or study, un- H. The petitioner is required to submit ei- less it is shown to fall within the ex- ther a claim for categorical exclusion under emption established for trade secrets § 25.30 or 25.32 of this chapter or an environ- and confidential commercial informa- mental assessment under § 25.40 of this chap- tion in § 20.61 of this chapter. ter. (iii) Adverse reaction reports, prod- Yours very truly, uct experience reports, consumer com- Petitioner llllllllllllllllll plaints, and other similar data and in- By llllllllllllllllllllll formation, after deletion of: (Indicate authority) (a) Names and any information that (d) The petitioner will be notified of would identify the person using the the date on which his petition is filed; product. and an incomplete petition, or one that (b) Names and any information that has not been submitted in triplicate, would identify any third party involved will usually be retained but not filed as with the report, such as a physician or a petition under section 409 of the Act. hospital or other institution. The petitioner will be notified in what (iv) A list of all ingredients contained respects his petition is incomplete. in a food additive, whether or not it is (e) The petition must be signed by in descending order of predominance. A the petitioner or by his attorney or particular ingredient or group of ingre- agent, or (if a corporation) by an au- dients shall be deleted from any such thorized official. list prior to public disclosure if it is (f) The data specified under the sev- shown to fall within the exemption es- eral lettered headings should be sub- tablished in § 20.61 of this chapter, and mitted on separate sheets or sets of a notation shall be made that any such sheets, suitably identified. If such data ingredient list is incomplete. have already been submitted with an (v) An assay method or other analyt- earlier application, the present peti- ical method, unless it serves no regu- tion may incorporate it by specific ref- latory or compliance purpose and is erence to the earlier. If part of the data shown to fall within the exemption es- have been submitted by the manufac- tablished in § 20.61 of this chapter. turer of the food additive as a master (2) The following data and informa- file, the petitioner may refer to the tion in a food additive petition are not master file if and to the extent he ob- available for public disclosure unless tains the manufacturer’s written per- they have been previously disclosed to mission to do so. The manufacturer the public as defined in § 20.81 of this may authorize specific reference to the chapter or they relate to a product or data without disclosure to the peti- ingredient that has been abandoned

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and they no longer represent a trade tioner does not wish to supplement or secret or confidential commercial or fi- explain the petition and requests in nancial information as defined in § 20.61 writing that it be filed as submitted, of this chapter: the petition shall be filed and the peti- (i) Manufacturing methods or proc- tioner so notified. esses, including quality control proce- (iii) Notwithstanding paragraph dures. (i)(1)(ii) of this section, the petition (ii) Production, sales, distribution, shall not be filed if the Food and Drug and similar data and information, ex- Administration determines that the cept that any compilation of such data use identified in the petition should be and information aggregated and pre- the subject of an FCN under section pared in a way that does not reveal 409(h) of the act rather than a petition. data or information which is not avail- (2) The Commissioner will publish in able for public disclosure under this the FEDERAL REGISTER within 30 days provision is available for public disclo- from the date of filing of such petition, sure. a notice of the filing, the name of the (iii) Quantitative or semiquantita- petitioner, and a brief description of tive formulas. the proposal in general terms. In the (3) All correspondence and written case of a food additive which becomes a summaries of oral discussions relating component of food by migration from to a food additive petition are avail- packaging material, the notice shall able for public disclosure in accordance include the name of the migratory sub- with the provisions of part 20 of this stance, and where it is different from chapter when the food additive regula- that of one of the original components, tion is published in the FEDERAL REG- the name of the parent component, the ISTER. maximum quantity of the migratory (4) For purposes of this regulation, substance that is proposed for use in safety and functionality data include food, and the physical or other tech- all studies and tests of a food additive nical effect which the migratory sub- on animals and humans and all studies stance or its parent component is in- and tests on a food additive for iden- tended to have in the packaging mate- tity, stability, purity, potency, per- rial. A copy of the notice will be formance, and usefulness. mailed to the petitioner when the (i)(1)(i) Within 15 days after receipt, original is forwarded to the FEDERAL the Food and Drug Administration will REGISTER for publication. notify the petitioner of the acceptance (j) The Commissioner may request a or nonacceptance of a petition, and if full description of the methods used in, not accepted, the reasons therefor. If and the facilities and controls used for, accepted, the petitioner will be sent a the production of the food additive, or letter stating this and the date of the a sample of the food additive, articles letter shall become the date of filing used as components thereof, or of the for the purposes of section 409(b)(5) of food in which the additive is proposed the act. In cases in which the Food and to be used, at any time while a petition Drug Administration agrees that a pre- is under consideration. The Commis- market notification for a food contact sioner shall specify in the request for a substance (Food Contact Notification sample of the food additive, or articles (FCN)) submitted under section 409(h) used as components thereof, or of the of the act may be converted to a peti- food in or on which the additive is pro- tion, the withdrawal date for the FCN posed to be used, a quantity deemed will be deemed the date of receipt for adequate to permit tests of analytical the petition. methods to determine quantities of the (ii) If the petitioner desires, he may food additive present in foods for which supplement a deficient petition after it is intended to be used or adequate being notified regarding deficiencies. If for any study or investigation reason- the supplementary material or expla- ably required with respect to the safety nation of the petition is deemed ac- of the food additive or the physical or ceptable, the petitioner shall be noti- technical effect it produces. The date fied. The date of such notification be- used for computing the 90-day limit for comes the date of filing. If the peti- the purposes of section 409(c)(2) of the

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Act shall be moved forward 1 day for USDA jurisdiction under specified con- each day after the mailing date of the ditions or restrictions. request taken by the petitioner to sub- [42 FR 14489, Mar. 15, 1977, as amended at 42 mit the sample. If the information or FR 15674, Mar. 22, 1977; 46 FR 8952, Jan. 27, sample is requested a reasonable time 1981; 50 FR 7492, Feb. 22, 1985; 50 16668, Apr. 26, in advance of the 180 days, but is not 1985; 62 FR 40599, July 29, 1997; 65 FR 51763, submitted within such 180 days after Aug. 25, 2000; 67 FR 35731, May 21, 2002] filing of the petition, the petition will EFFECTIVE DATE NOTE: At 65 FR 51763, Aug. be considered withdrawn without prej- 25, 2000, § 171.1 was amended in paragraph (a) udice. by revising the first sentence, in paragraph (k) If nonclinical laboratory studies (c) in the petition by revising the introduc- are involved, petitions filed with the tory paragraph preceding paragraph A., and Commissioner under section 409(b) of by adding paragraph (n). The revised and the act shall include, with respect to added text contains information collection and recordkeeping requirements and will not each nonclinical study contained in the become effective until approval has been petition, either a statement that the given by the Office of Management and study has been, or will be, conducted in Budget. compliance with the good laboratory practice regulations as set forth in part § 171.6 Amendment of petition. 58 of this chapter, or, if any such study After a petition has been filed, the was not conducted in compliance with petitioner may submit additional in- such regulations, a brief statement of formation or data in support thereof. the reason for the noncompliance. In such cases, if the Commissioner de- (l) [Reserved] termines that the additional informa- (m) If clinical investigations involv- tion or data amount to a substantive ing human subjects are involved, peti- amendment, the petition as amended tions filed with the Commissioner will be given a new filing date, and the under section 409(b) of the Act shall in- time limitation will begin to run anew. clude statements regarding each such If nonclinical laboratory studies are in- clinical investigation relied upon in volved, additional information and the petition that it either was con- data submitted in support of filed peti- ducted in compliance with the require- tions shall include, with respect to ments for institutional review set forth each nonclinical study, either a state- in part 56 of this chapter, or was not ment that the study was conducted in subject to such requirements in accord- compliance with the requirements set ance with § 56.104 or § 56.105, and that it forth in part 58 of this chapter, or, if was conducted in compliance with the the study was not conducted in compli- requirements for informed consent set ance with such regulations, a brief forth in part 50 of this chapter. statement of the reason for the non- (n)(1) If intended uses of the food ad- compliance. ditive include uses in meat, meat food [50 FR 7492, Feb. 22, 1985, as amended at 50 product, or poultry product subject to 16668, Apr. 26, 1985] regulation by the U.S. Department of Agriculture (USDA) under the Poultry § 171.7 Withdrawal of petition without Products Inspection Act (PPIA) (21 prejudice. U.S.C. 451 et seq.) or the Federal Meat (a) In some cases the Commissioner Inspection Act (FMIA) (21 U.S.C. 601 et will notify the petitioner that the peti- seq.), FDA shall, upon filing of the petition, while technically complete, is in- tion, forward a copy of the petition or adequate to justify the establishment relevant portions thereof to the Food of a regulation or the regulation re- Safety and Inspection Service, USDA, quested by petitioner. This may be due for simultaneous review under the to the fact that the data are not suffi- PPIA and FMIA. ciently clear or complete. In such (2) FDA will ask USDA to advise cases, the petitioner may withdraw the whether the proposed meat and poultry petition pending its clarification or the uses comply with the FMIA and PPIA, obtaining of additional data. This with- or if not, whether use of the substance drawal will be without prejudice to a would be permitted in products under future filing. Upon refiling, the time

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limitation will begin to run anew from mitted to remain in or on such food, the date of refiling. the manner in which such additive may (b) At any time before the order pro- be added to or used in or on such food, vided for in § 171.100(a) has been for- and any directions or other labeling or warded to the FEDERAL REGISTER for packaging requirements for such addi- publication, the petitioner may with- tive deemed necessary by him to assure draw the petition without prejudice to the safety of such use), and prior to the a future filing. Upon refiling the time forwarding of the order to the FEDERAL limitation will begin to run anew. REGISTER for publication shall notify (c) Any petitioner who has a food ad- the petitioner of such order and the ditive petition pending before the agen- reasons for such action; or by order cy and who subsequently submits a deny the petition, and shall notify the premarket notification for a food con- petitioner of such order and of the rea- tact substance (FCN) for a use or uses sons for such action. described in such petition shall be (b) The regulation shall describe the deemed to have withdrawn the petition conditions under which the substance for such use or uses without prejudice may be safely used in any meat prod- to a future filing on the date the FCN uct, meat food product, or poultry is received by the Food and Drug Ad- product subject to the Federal Meat In- ministration. spection Act (FMIA) (21 U.S.C. 601 et [42 FR 14489, Mar. 15, 1977, as amended at 67 seq.) or the Poultry Products Inspec- FR 35731, May 21, 2002] tion Act (PPIA) (21 U.S.C. 451 et seq.). (c) If the Commissioner determines § 171.8 Threshold of regulation for that additional time is needed to study substances used in food-contact ar- and investigate the petition, he shall ticles. by written notice to the petitioner ex- Substances used in food-contact arti- tend the 90-day period for not more cles (e.g., food-packaging or food-proc- than 180 days after the filing of the pe- essing equipment) that migrate or that tition. may be expected to migrate into food [42 FR 14489, Mar. 15, 1977, as amended at 65 at negligible levels may be reviewed FR 51763, Aug. 25, 2000] under § 170.39 of this chapter. The Food and Drug Administration will exempt § 171.102 Effective date of regulation. substances whose uses it determines A regulation published in accordance meet the criteria in § 170.39 of this with § 171.100(a) shall become effective chapter from regulation as food addi- upon publication in the FEDERAL REG- tives and, therefore, a food additive pe- ISTER. tition will not be required for the exempted use. § 171.110 Procedure for objections and [60 FR 36596, July 17, 1995] hearings. Objections and hearings relating to Subpart B—Administrative Actions food additive regulations under section on Applications 409 (c), (d), or (h) of the Act shall be governed by part 12 of this chapter. § 171.100 Regulation based on petition. [42 FR 14491, Mar. 15, 1977, as amended at 42 (a) The Commissioner will forward FR 15674, Mar. 22, 1977] for publication in the FEDERAL REG- ISTER, within 90 days after filing of the § 171.130 Procedure for amending and petition (or within 180 days if the time repealing tolerances or exemptions is extended as provided for in section from tolerances. 409(c)(2) of the Act), a regulation pre- (a) The Commissioner, on his own scribing the conditions under which initiative or on the petition of any in- the food additive may be safely used terested person, pursuant to part 10 of (including, but not limited to, speci- this chapter, may propose the issuance fications as to the particular food or of a regulation amending or repealing a classes of food in or on which such ad- regulation pertaining to a food additive ditive may be used, the maximum or granting or repealing an exception quantity that may be used or per- for such additive.

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(b) Any such petition shall include an 172.260 Oxidized polyethylene. assertion of facts, supported by data, 172.270 Sulfated butyl oleate. showing that new information exists 172.275 Synthetic paraffin and succinic de- with respect to the food additive or rivatives. 172.280 Terpene resin. that new uses have been developed or old uses abandoned, that new data are Subpart D—Special Dietary and Nutritional available as to toxicity of the chem- Additives ical, or that experience with the existing regulation or exemption may jus- 172.310 Aluminum nicotinate. tify its amendment or repeal. New data 172.315 Nicotinamide-ascorbic acid complex. shall be furnished in the form specified 172.320 Amino acids. 172.325 Bakers yeast protein. in §§ 171.1 and 171.100 for submitting pe- 172.330 Calcium pantothenate, calcium chlo- titions. ride double salt. [42 FR 14491, Mar. 15, 1977, as amended at 42 172.335 D-Pantothenamide. FR 15674, Mar. 22, 1977] 172.340 Fish protein isolate. 172.345 Folic acid (folacin). 172.350 Fumaric acid and salts of fumaric PART 172—FOOD ADDITIVES PER- acid. MITTED FOR DIRECT ADDITION TO 172.365 Kelp. FOOD FOR HUMAN CONSUMP- 172.370 Iron-choline citrate complex. 172.372 N-Acetyl-L-methionine. TION 172.375 Potassium iodide. 172.380 Vitamin D3. Subpart A—General Provisions 172.385 Whole fish protein concentrate. 172.395 Xylitol. Sec. 172.399 Zinc methionine sulfate. 172.5 General provisions for direct food additives. Subpart E—Anticaking Agents Subpart B—Food Preservatives 172.410 Calcium silicate. 172.430 Iron ammonium citrate. 172.105 Anoxomer. 172.110 BHA. 172.480 Silicon dioxide. 172.115 BHT. 172.490 Yellow prussiate of soda. 172.120 Calcium disodium EDTA. 172.130 Dehydroacetic acid. Subpart F—Flavoring Agents and Related 172.133 Dimethyl dicarbonate. Substances 172.135 Disodium EDTA. 172.140 Ethoxyquin. 172.510 Natural flavoring substances and 172.145 Heptylparaben. natural substances used in conjunction 172.150 4-Hydroxymethyl-2,6-di-tert-butyl- with flavors. phenol. 172.515 Synthetic flavoring substances and 172.155 Natamycin (pimaricin). adjuvants. 172.160 Potassium nitrate. 172.520 Cocoa with dioctyl sodium sulfo- 172.165 Quaternary ammonium chloride succinate for manufacturing. combination. 172.530 Disodium guanylate. 172.170 Sodium nitrate. 172.535 Disodium inosinate. 172.175 Sodium nitrite. 172.540 DL-Alanine. 172.177 Sodium nitrite used in processing 172.560 Modified hop extract. smoked chub. 172.575 Quinine. 172.180 Stannous chloride. 172.580 Safrole-free extract of sassafras. 172.185 TBHQ. 172.585 Sugar beet extract flavor base. 172.190 THBP. 172.590 Yeast-malt sprout extract.

Subpart C—Coatings, Films and Related Subpart G—Gums, Chewing Gum Bases Substances and Related Substances 172.210 Coatings on fresh citrus fruit. 172.610 Arabinogalactan. 172.215 Coumarone-indene resin. 172.615 Chewing gum base. 172.225 Methyl and ethyl esters of fatty 172.620 Carrageenan. acids produced from edible fats and oils. 172.623 Carrageenan with polysorbate 80. 172.230 Microcapsules for flavoring sub- 172.626 Salts of carrageenan. stances. 172.655 Furcelleran. 172.235 Morpholine. 172.660 Salts of furcelleran. 172.250 Petroleum naphtha. 172.665 Gellan gum. 172.255 Polyacrylamide. 172.695 Xanthan gum.

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Subpart H—Other Specific Usage Additives 172.863 Salts of fatty acids. 172.864 Synthetic fatty alcohols. 172.710 Adjuvants for pesticide use dilu- 172.866 Synthetic glycerin produced by the tions. hydrogenolysis of carbohydrates. 172.712 1,3–Butylene glycol. 172.867 Olestra. 172.715 Calcium lignosulfonate. 172.868 Ethyl cellulose. 172.720 Calcium lactobionate. 172.869 Sucrose oligoesters. 172.723 Epoxidized soybean oil. 172.870 Hydroxypropyl cellulose. 172.725 Gibberellic acid and its potassium 172.872 Methyl ethyl cellulose. salt. 172.874 Hydroxypropyl methylcellulose. 172.730 Potassium bromate. 172.876 Castor oil. 172.735 Glycerol ester of wood rosin. 172.878 White mineral oil. 172.755 Stearyl monoglyceridyl citrate. 172.880 Petrolatum. 172.765 Succistearin (stearoyl propylene gly- 172.882 Synthetic isoparaffinic petroleum col hydrogen succinate). hydrocarbons. 172.770 Ethylene oxide polymer. 172.884 Odorless light petroleum hydro- 172.775 Methacrylic acid-divinylbenzene co- carbons. polymer. 172.886 Petroleum wax. Subpart I—Multipurpose Additives 172.888 Synthetic petroleum wax. 172.890 Rice bran wax. 172.800 Acesulfame potassium. 172.892 Food starch-modified. 172.802 Acetone peroxides. 172.894 Modified cottonseed products in- 172.804 Aspartame. tended for human consumption. 172.806 Azodicarbonamide. 172.896 Dried yeasts. 172.808 Copolymer condensates of ethylene 172.898 Bakers yeast glycan. oxide and propylene oxide. AUTHORITY: 21 U.S.C. 321, 341, 342, 348, 371, 172.809 Curdlan. 379e. 172.810 Dioctyl sodium sulfosuccinate. 172.811 Glyceryl tristearate. SOURCE: 42 FR 14491, Mar. 15, 1977, unless 172.812 Glycine. otherwise noted. 172.814 Hydroxylated lecithin. 172.816 Methyl glucoside-coconut oil ester. EDITORIAL NOTE: Nomenclature changes to 172.818 Oxystearin. part 172 appear at 61 FR 14482, Apr. 2, 1996, 66 172.820 Polyethylene gylcol (mean molec- FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, ular weight 200–9,500). 2001, and 68 FR 15355, Mar. 31, 2003. 172.822 Sodium lauryl sulfate. 172.824 Sodium mono- and dimethyl naph- Subpart A—General Provisions thalene sulfonates. 172.826 Sodium stearyl fumarate. § 172.5 General provisions for direct 172.828 Acetylated monoglycerides. food additives. 172.829 Neotame. 172.830 Succinylated monoglycerides. (a) Regulations prescribing condi- 172.831 Sucralose. tions under which food additive sub- 172.832 Monoglyceride citrate. stances may be safely used predicate 172.833 Sucrose acetate isobutyrate (SAIB). usage under conditions of good manu- 172.834 Ethoxylated mono- and diglycerides. facturing practice. For the purposes of 172.836 Polysorbate 60. 172.838 Polysorbate 65. this part, good manufacturing practice 172.840 Polysorbate 80. shall be defined to include the fol- 172.841 Polydextrose. lowing restrictions. 172.842 Sorbitan monostearate. (1) The quantity of the substance 172.844 Calcium stearoyl-2-lactylate. added to food does not exceed the 172.846 Sodium stearoyl lactylate. amount reasonably required to accom- 172.848 Lactylic esters of fatty acids. plish its intended physical, nutritive, 172.850 Lactylated fatty acid esters of glycerol and propylene glycol. or other technical effect in food. 172.852 Glyceryl-lacto esters of fatty acids. (2) Any substance intended for use in 172.854 Polyglycerol esters of fatty acids. or on food is of appropriate food grade 172.856 Propylene glycol mono- and diesters and is prepared and handled as a food of fats and fatty acids. ingredient. 172.858 Propylene glycol alginate. (b) The existence of a regulation pre- 172.859 Sucrose fatty acid esters. scribing safe conditions of use for a 172.860 Fatty acids. 172.861 Cocoa butter substitute from coco- food additive shall not be construed to nut oil, palm kernel oil, or both oils. relieve the use of the substance from 172.862 Oleic acid derived from tall oil fatty compliance with any other provision of acids. the Act.

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(c) The existence of any regulation Nutrition (HFS–200), Food and Drug prescribing safe conditions of use for a Administration, 5100 Paint Branch nutrient substance does not constitute Pkwy., College Park, MD 20740, or a finding that the substance is useful available for inspection at the Office of or required as a supplement to the diet the Federal Register, 800 North Capitol of humans. Street, NW., suite 700, Washington, DC 20408. Subpart B—Food Preservatives (4) Heavy metals as lead (as Pb), not more than 10 parts per million. Arsenic § 172.105 Anoxomer. (as As), not more than 3 parts per mil- Anoxomer as identified in this sec- lion. Mercury (as Hg), not more than 1 tion may be safely used in accordance part per million. with the following conditions: (c) Anoxomer may be safely used as (a) Anoxomer is 1,4-benzenediol, 2- an antioxidant in food at a level of not (1,1-dimethylethyl)-polymer with more than 5,000 parts per million based diethenylbenzene, 4-(1,1-dimethyl- on fat and oil content of the food. ethyl)phenol, 4- methoxyphenol, 4,4′-(1- [48 FR 18798, Apr. 26, 1983, as amended at 54 methylethylidene)bis(phenol) and 4- FR 24896, June 12, 1989] methylphenol (CAS Reg. No. 60837–57–2) prepared by condensation polymeriza- § 172.110 BHA. tion of divinylbenzene (m- and p-) with The food additive BHA (butylated hy- tert-butylhydroquinone, tert-butyl- droxyanisole) alone or in combination phenol, hydroxyanisole, p-cresol and with other antioxidants permitted in 4,4′-isopropylidenediphenol. food for human consumption in this (b) The polymeric antioxidant meets subpart B may be safely used in or on the following specifications: (1) Polymer, not less than 98.0 per- specified foods, as follows: cent as determined by an ultraviolet (a) The BHA meets the following method entitled ‘‘Ultraviolet Assay, specification: ‘‘1982, which is incorporated by ref- Assay (total BHA), 98.5 percent minimum. erence. Copies are available from the Melting point 48 °C minimum. Center for Food Safety and Applied Nu- (b) The BHA is used alone or in com- trition (HFS–200), Food and Drug Ad- bination with BHT, as an antioxidant ministration, 5100 Paint Branch Pkwy., in foods, as follows: College Park, MD 20740, or available for inspection at the Office of the Federal Limitations Register, 800 North Capitol Street, (total BHA Food and BHT) NW., suite 700, Washington, DC 20408. parts per (2) Molecular weight: Total mono- million mers, dimers and trimers below 500 not Dehydrated potato shreds ...... 50 more than 1 percent as determined by a Active dry yeast ...... 1 1,000 method entitled ‘‘Low Molecular Beverages and desserts prepared from dry Weight Anoxomer Analysis,’’ 1982, mixes ...... 1 2 Dry breakfast cereals ...... 50 which is incorporated by reference. Dry diced glazed fruit ...... 1 32 Copies are available from the Center Dry mixes for beverages and desserts ...... 1 90 for Food Safety and Applied Nutrition Emulsion stabilizers for shortenings ...... 200 (HFS–200), Food and Drug Administra- Potato flakes ...... 50 Potato granules ...... 10 tion, 5100 Paint Branch Pkwy., College Sweet potato flakes ...... 50 Park, MD 20740, or available for inspec- 1 BHA only. tion at the Office of the Federal Reg- ister, 800 North Capitol Street, NW., (c) To assure safe use of the additive: suite 700, Washington, DC 20408. (1) The label of any market package (3) Phenol content: Not less than 3.2 of the additive shall bear, in addition milliequivalent/gram and not more to the other information required by than 3.8 milliequivalent/gram as deter- the Act, the name of the additive. mined by a method entitled ‘‘Total (2) When the additive is marketed in Phenols,’’ 1982, which is incorporated a suitable carrier, in addition to meet- by reference. Copies are available from ing the requirement of paragraph (c)(1) the Center for Food Safety and Applied of this section, the label shall declare

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the percentage of the additive in the (1) Alone, in the following foods at mixture. not to exceed the levels prescribed, cal- (3) The label or labeling of dry mixes culated as the anhydrous compound: for beverages and desserts shall bear Limita- adequate directions for use to provide tion that beverages and desserts prepared Food (parts Use per mil- from the dry mixes contain no more lion) than 2 parts per million BHA. Cabbage, pickled ...... 220 Promote color, flavor, § 172.115 BHT. and texture retention. Canned carbonated soft 33 Promote flavor reten- The food additive BHT (butylated hy- drinks. tion. droxytoluene), alone or in combination Canned white potatoes 110 Promote color retention. Clams (cooked canned) 340 Promote color retention. with other antioxidants permitted in Crabmeat (cooked 275 Retard struvite forma- this subpart B may be safely used in or canned). tion; promote color on specified foods, as follows: retention. (a) The BHT meets the following Cucumbers pickled ...... 220 Promote color, flavor, and texture retention. specification: Assay (total BHT) 99 per- Distilled alcoholic bev- 25 Promote stability of cent minimum. erages. color, flavor, and/or (b) The BHT is used alone or in com- product clarity. Dressings, nonstandard- 75 Preservative. bination with BHA, as an antioxidant ized. in foods, as follows: Dried lima beans 310 Promote color retention. (cooked canned). Limitations Egg product that is 1 200 Preservative. (total BHA hard-cooked and con- Food and BHT) sists, in a cylindrical parts per million shape, of egg white with an inner core of Dehydrated potato shreds ...... 50 egg yolk. Fermented malt bev- 25 Antigushing agent. Dry breakfast cereals ...... 50 erages. Emulsion stabilizers for shortenings ...... 200 French dressing ...... 75 Preservative. Potato flakes ...... 50 Legumes (all cooked 365 Promote color retention. Potato granules ...... 10 canned, other than Sweetpotato flakes ...... 50 dried lima beans, pink beans, and red (c) To assure safe use of the additive: beans). Mayonnaise ...... 75 Do. (1) The label of any market package Mushrooms (cooked 200 Promote color retention. of the additive shall bear, in addition canned). to the other information required by Oleomargarine ...... 75 Preservative. the Act, the name of the additive. Pecan pie filling ...... 100 Promote color retention. Pink beans (cooked 165 Promote color retention. (2) When the additive is marketed in canned). a suitable carrier, in addition to meet- Potato salad ...... 100 Preservative. ing the requirement of paragraph (c)(1) Processed dry pinto 800 Promote color retention. of this section, the label shall declare beans. Red beans (cooked 165 Promote color retention. the percentage of the additive in the canned). mixture. Salad dressing ...... 75 Preservative. Sandwich spread ...... 100 Do. § 172.120 Calcium disodium EDTA. Sauces ...... 75 Do. Shrimp (cooked 250 Retard struvite forma- The food additive calcium disodium canned). tion; promote color EDTA (calcium disodium ethylene- retention. Spice extractives in 60 Promote color and fla- diaminetetraacetate) may be safely soluble carriers. vor retention. used in designated foods for the pur- Spreads, artificially col- 100 Promote color retention. poses and in accordance with the condi- ored and lemon-fla- tions prescribed, as follows: vored or orange-flavored. (a) The additive contains a minimum of 99 percent by weight of either the di- 1 By weight of egg yolk portion. hydrate C10H12O8N2CaNa2·2H2O or the (2) With disodium EDTA (disodium trihydrate C10H12O8N2CaNa2·3H2O, or ethylenediaminetetraacetate) in the any mixture of the two. following foods at not to exceed, in (b) It is used or intended for use as combination, the levels prescribed, cal- follows: culated as anhydrous C10H12O8N2CaNa2: 33

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Limita- accordance with the following pre- tion scribed conditions: Food (parts Use per mil- (a) The additive meets the following lion) specifications: Dressings, nonstandardized .... 75 Preservative. (1) The additive has a purity of not French dressing ...... 75 Do. less than 99.8 percent as determined by Mayonnaise ...... 75 Do. the following titration method: Salad dressing ...... 75 Do. Sandwich spread ...... 100 Do. PRINCIPLES OF METHOD Sauces ...... 75 Do. Dimethyl dicarbonate (DMDC) is mixed with excess diisobutylamine with which it (c) To assure safe use of the additive: reacts quantitatively. The excess amine is (1) The label and labeling of the addi- backtitrated with acid. tive container shall bear, in addition to the other information required by the APPARATUS Act, the name of the additive. 250-milliliter (mL) Beaker (2) The label or labeling of the addi- 100-mL Graduate cylinder tive container shall bear adequate use 25-mL Pipette 10-mL Burette (automatic, eg., Metrohm bu- directions to provide a final food prod- rette) uct that complies with the limitations Stirrer provided in paragraph (b) of this sec- Device for potentiometric titration tion. Reference electrode (d) In the standardized foods listed in Glass electrode paragraph (b) of this section, the addi- REAGENTS tives are used only in compliance with the applicable standards of identity for Acetone, analytical-grade Solution of 1 N diisobutylamine in chloro- such foods. benzene, distilled [42 FR 14491, Mar. 15, 1977, as amended at 48 1 N Acetic Acid FR 10815, Mar. 15, 1983; 58 FR 52222, Oct. 7, PROCEDURE 1993; 60 FR 33710, June 29, 1995; 65 FR 48379, Aug. 8, 2000] Accurately weigh in about 2 grams of the sample (W) and dissolve in 100 mL acetone. § 172.130 Dehydroacetic acid. Add accurately 25 mL of the 1 N diisobutylamine solution by pipette and allow to stand The food additive dehydroacetic acid for 5 minutes. Subsequently, titrate the re- and/or its sodium salt may be safely action mixture potentiometrically with 1 N used in accordance with the following hydrochloric acid (consumption=a mL) while prescribed conditions: stirring. For determining the blank con- (a) The food additive meets the fol- sumption, carry out the analysis without a lowing specifications: sample (consumption=b mL). Dehydroacetic acid: Melting point, 109 °C–111 CALCULATION °C; assay, minimum 98 percent (dry basis). Sodium salt of dehydroacetic acid: Assay, ()ba− ×13. 4 minimum 98 percent (dry basis). = % DMDC (b) It is used or intended for use as a W preservative for cut or peeled squash, NOTE: For adding the diisobutylamine so- and is so used that no more than 65 lution, always use the same pipette and wait for a further three drops to fall when the parts per million expressed as dehydro- flow has stopped. acetic acid remains in or on the pre- (2) The additive contains not more pared squash. than 2,000 ppm (0.2 percent) dimethyl (c) The label or labeling of any pack- carbonate as determined by a method age of the additive intended for use in entitled ‘‘Gas Chromatography Method food shall bear adequate directions for for Dimethyl Carbonate Impurity in use to insure compliance with this sec- Dimethyl Dicarbonate,’’ whichis incor- tion. porated by reference in accordance with 5 U.S.C. 552(a). Copies are avail- § 172.133 Dimethyl dicarbonate. able from the Center for Food Safety Dimethyl dicarbonate (CAS Reg. No. and Applied Nutrition (HFS–200), 5100 4525–33–1) may be safely used in food in Paint Branch Pkwy., College Park, MD

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20740, or available for inspection at the (a) The additive contains a minimum Office of the Federal Register, 800 of 99 percent disodium ethylenedia- North Capitol Street, NW., suite 700, minetetraacetate dihydrate Washington, DC 20408. (C10H14O8N2Na2·2H2O). (b) The additive is used or intended (b) It is used or intended for use as for use as a microbial control agent in follows: the following beverages under normal (1) Alone, in the following foods at circumstances of bottling, canning, or not to exceed the levels prescribed, cal- other forms of final packaging, where culated as anhydrous calcium disodium the viable microbial load has been re- EDTA: duced to 500 microorganisms per milli- Limita- liter or less by current good manufac- tion turing practices such as heat treat- Food (parts Use per mil- ment, filtration, or other technologies lion) prior to the use of dimethyl dicarbonate: Aqueous multivitamin prep- 150 With iron salts as a (1) In wine, dealcoholized wine, and arations. stabilizer for vitamin B 12 in liquid low alcohol wine in an amount not to multivitamin prep- exceed 200 parts per million. arations. (2) In ready–to–drink teas in an Canned black-eyed peas .... 145 Promote color re- amount not to exceed 250 parts per mil- tention. Canned kidney beans ...... 165 Preservative. lion. Canned strawberry pie filling 500 Promote color re- (3) In carbonated or noncarbonated, tention. nonjuice–containing (less than or equal Cooked sausage ...... 36 As a cure accelerator with so- to 1 percent juice), flavored or dium ascorbate unflavored beverages containing added or ascorbic acid. electrolytes (5–20 milliequivalents/liter Dressings, nonstandardized 75 Preservative. sodium ion (Na+) and 3–7 milli- French dressing ...... 75 Do. Frozen white potatoes in- 100 Promote color re- equivalents/liter potassium ion (K+)) in cluding cut potatoes. tention. an amount not to exceed 250 parts per Gefilte fish balls or patties in 1 50 Inhibit discoloration. million. packing medium. (4) In carbonated, dilute beverages Legumes (all cooked 165 Promote color re- canned, other than black- tention. containing juice, fruit flavor, or both, eyed peas). with juice content not to exceed 50 per- Mayonnaise ...... 75 Preservative. cent, in an amount not to exceed 250 Ready-to-eat cereal prod- 2 315 Promote color re- parts per million. ucts containing dried ba- tention. nanas. (c) To ensure the safe use of the food Salad dressing ...... 75 Preservative. additive, the label of the package con- Sandwich spread ...... 100 Do. taining the additive shall bear, in addi- Sauces ...... 75 Do. tion to other information required by 1 Based on total weight of finished product including packing the Federal Food, Drug, and Cosmetic medium. 2 In dried banana component of cereal product. Act: (1) The name of the additive ‘‘di- (2) With calcium disodium EDTA methyl dicarbonate.’’ (calcium disodium ethylenediamine- (2) The intended use of the additive. tetraacetate; calcium disodium (3) Adequate directions for use to en- (ethylenedinitrilo) tetraacetate), in the sure compliance with this section. following foods at not to exceed, in combination, the levels prescribed, cal- [53 FR 41329, Oct. 21, 1988, as amended at 58 FR 6091, Jan. 26, 1993; 59 FR 5319, Feb. 4, 1994; culated as anhydrous C10H12O8N2CaNa2: 61 FR 14245, Apr. 1, 1996; 61 FR 26788, May 29, Limita- 1996; 66 FR 13653, Mar. 7, 2001] tion Food (parts Use per mil- § 172.135 Disodium EDTA. lion) The food additive disodium EDTA Dressings, nonstandardized 75 Preservative. (disodium ethylenediaminetetraace- French dressing ...... 75 Do. tate) may be safely used in designated Mayonnaise ...... 75 Do. foods for the purposes and in accord- Salad dressing ...... 75 Do. ance with the following prescribed con- Sandwich spread ...... 100 Do. ditions: Sauces ...... 75 Do.

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(3) Alone, as a sequestrant in the (1) In fermented malt beverages in nonnutritive sweeteners that are listed amounts not to exceed 12 parts per mil- in § 180.37 of this chapter and that, in lion. addition, are designed for aqueous solu- (2) In noncarbonated soft drinks and tion: Provided, That the amount of the fruit-based beverages in amounts not additive, calculated as anhydrous cal- to exceed 20 parts per million, when cium disodium EDTA, does not exceed standards of identity established under 0.1 percent by weight of the dry non- section 401 of the Act (21 U.S.C. 341) do nutritive sweetener. not preclude such use. (c) To assure the safe use of the additive: § 172.150 4-Hydroxymethyl-2,6-di-tert- (1) The label and labeling of the addi- butylphenol. tive container shall bear, in addition to The food additive 4-hydroxymethyl- the other information required by the 2,6-di-tert-butylphenol may be safely act, the name of the additive. used in food in accordance with the fol- (2) The label or labeling of the addi- lowing prescribed conditions: tive container shall bear adequate use (a) The additive has a solidification directions to provide a final food prod- point of 140 °C–141 °C. uct that complies with the limitations (b) The additive is used as an anti- provided in paragraph (b) of this sec- oxidant alone or in combination with tion. other permitted antioxidants. (d) In the standardized foods listed in (c) The total amount of all anti- paragraphs (b) (1) and (2) of this section oxidants added to such food shall not the additives are used only in compli- exceed 0.02 percent of the oil or fat con- ance with the applicable standards of tent of the food, including the essential identity for such foods. (volatile) oil content of the food. [42 FR 14491, Mar. 15, 1977, as amended at 65 FR 48379, Aug. 8, 2000] § 172.155 Natamycin (pimaricin). (a) Natamycin (CAS Reg. No. 7681–93– § 172.140 Ethoxyquin. 8), also known as pimaricin, is a pol- (a) Ethoxyquin (1,2-dihydro-6-ethoxy- yene macrolide antimycotic substance 2,2,4-trimethylquinoline) may be safely possessing an empirical formula of used as an antioxidant for preservation C33H47NO13 and a molecular weight of of color in the production of chili pow- 665.7. der, paprika, and ground chili at levels (b) The additive shall conform to the not in excess of 100 parts per million. following specifications: (b) In order to provide for the safe ± use of the additive in feed prepared in Purity: 97 percent 2 percent on an anhydrous basis. accordance with §§ 573.380 and 573.400 of Arsenic: Not more than 1 part per million. this chapter, tolerances are established Heavy metals (as Pb): Not more than 20 parts for residues of ethoxyquin in or on edi- per million. ble products of animals as follows: (c) The additive may be applied on 5 parts per million in or on the uncooked fat cheese, as an antimycotic, in amounts of meat from animals except poultry. not to exceed 20 milligrams per kilo- 3 parts per million in or on the uncooked liver and fat of poultry. gram (20 parts per million) in the fin- 0.5 part per million in or on the uncooked ished product as determined by Inter- muscle meat of animals. national Dairy Federation (IDF) Stand- 0.5 part per million in poultry eggs. ard 140A:1992, ‘‘Cheese and Cheese Zero in milk. Rind-Determination of Natamycin Con- tent-Method by Molecular Absorption § 172.145 Heptylparaben. Spectrometry and by High-Perform- (a) The food additive heptylparaben ance Liquid Chromatography,’’ which is the chemical n-heptyl p-hydroxy- is incorporated by reference. The Di- benzoate. rector of the Office of the Federal Reg- (b) It may be safely used to inhibit ister approves this incorporation by microbiological spoilage in accordance reference in accordance with 5 U.S.C. with the following prescribed condi- 552(a) and 1 CFR part 51. Copies are tions: available from the Division of Product

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Policy (HFS–206), Center for Food Safe- Component Parts per ty and Applied Nutrition, Food and million Drug Administration, 5100 Paint n-Dodecyl dimethyl ethylbenzyl ammonium Branch Pkwy., College Park, MD 20740, chloride ...... 3.4–13.5 or may be examined at the Center for n-Hexadecyl dimethyl benzyl ammonium chlo- Food Safety and Applied Nutrition’s ride ...... 1.5–6.0 n-Octadecyl dimethyl benzyl ammonium chlo- Library, 5100 Paint Branch Pkwy., Col- ride ...... 0.25–1.0 lege Park, MD 20740, or at the Office of n-Tetradecyl dimethyl benzyl ammonium chlo- the Federal Register, 800 North Capitol ride ...... 3.0–12.0 n-Tetradecyl dimethyl ethylbenzyl ammonium St. NW., suite 700, Washington, DC. chloride ...... 1.6–6.5 [47 FR 26823, June 22, 1982, as amended at 50 FR 49536, Dec. 3, 1985; 63 FR 66015, Dec. 1, [50 FR 3890, Jan. 29, 1985] 1998; 66 FR 13847, Mar. 8, 2001] § 172.170 Sodium nitrate. § 172.160 Potassium nitrate. The food additive sodium nitrate The food additive potassium nitrate may be safely used in or on specified may be safely used as a curing agent in foods in accordance with the following the processing of cod roe, in an amount prescribed conditions: not to exceed 200 parts per million of (a) It is used or intended for use as the finished roe. follows: § 172.165 Quaternary ammonium chlo- (1) As a preservative and color fixa- ride combination. tive, with or without sodium nitrite, in smoked, cured sablefish, smoked, cured The food additive, quaternary ammo- salmon, and smoked, cured shad, so nium chloride combination, may be that the level of sodium nitrate does safely used in food in accordance with not exceed 500 parts per million and the the following conditions: (a) The additive contains the fol- level of sodium nitrite does not exceed 200 parts per million in the finished lowing compounds: n-dodecyl dimethyl benzyl ammonium chloride (CAS Reg. product. No. 139–07–1); n-dodecyl dimethyl ethyl- (2) As a preservative and color fixa- benzyl ammonium chloride (CAS Reg. tive, with or without sodium nitrite, in No. 27479–28–3); n-hexadecyl dimethyl meat-curing preparations for the home benzyl ammonium chloride (CAS Reg. curing of meat and meat products (in- No. 122–18–9); n-octadecyl dimethyl cluding poultry and wild game), with benzyl ammonium chloride (CAS Reg. directions for use which limit the No. 122–19–0); n-tetradecyl dimethyl amount of sodium nitrate to not more benzyl ammonium chloride (CAS Reg. than 500 parts per million in the fin- No. 139–08–2); n-tetradecyl dimethyl ished meat product and the amount of ethylbenzyl ammonium chloride (CAS sodium nitrite to not more than 200 Reg. No. 27479–29–4). parts per million in the finished meat (b) The additive meets the following product. specifications: pH (5 percent active so- (b) To assure safe use of the additive, lution) 7.0–8.0; total amines, maximum in addition to the other information re- 1 percent as combined free amines and quired by the Act: amine hydrochlorides. (1) The label of the additive or of a (c) The additive is used as an anti- mixture containing the additive shall microbial agent, as defined in bear: § 170.3(o)(2) of this chapter, in raw sugar (i) The name of the additive. cane juice. It is added prior to clari- (ii) A statement of the concentration fication when further processing of the of the additive in any mixture. sugar cane juice must be delayed. (2) If in a retail package intended for (d) The additive is applied to the household use, the label and labeling of sugar juice in the following quantities, the additive, or of a mixture con- based on the weight of the raw cane: taining the additive, shall bear adequate directions for use to provide a Component Parts per final food product that complies with million the limitations prescribed in paragraph n-Dodecyl dimethyl benzyl ammonium chloride 0.25–1.0 (a) of this section.

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(3) If in a retail package intended for ditive, shall bear the statement ‘‘Keep household use, the label of the additive out of the reach of children’’. or of a mixture containing the additive, shall bear the statement ‘‘Keep § 172.177 Sodium nitrite used in proc- out of the reach of children’’. essing smoked chub. The food additive sodium nitrite may § 172.175 Sodium nitrite. be safely used in combination with salt The food additive sodium nitrite may (NaCl) to aid in inhibiting the out- be safely used in or on specified foods growth and toxin formation from Clos- in accordance with the following pre- tridium botulinum type E in the com- scribed conditions: mercial processing of smoked chub in (a) It is used or intended for use as accordance with the following pre- follows: scribed conditions: (1) As a color fixative in smoked (a) All fish in smoking establish- cured tunafish products so that the ments shall be clean and wholesome level of sodium nitrite does not exceed and shall be expeditiously processed, 10 parts per million (0.001 percent) in packed, and stored under adequate san- the finished product. itary conditions in accordance with (2) As a preservative and color fixa- good manufacturing practice. tive, with or without sodium nitrate, (b) The brining procedure is con- in smoked, cured sablefish, smoked, trolled in such a manner that the cured salmon, and smoked, cured shad water phase portion of the edible por- so that the level of sodium nitrite does tion of the finished smoked product has not exceed 200 parts per million and the a salt (NaCl) content of not less than level of sodium nitrate does not exceed 3.5 percent, as measured in the loin 500 parts per million in the finished muscle, and the sodium nitrite content product. of the edible portion of the finished (3) As a preservative and color fixa- smoked product is not less than 100 tive, with sodium nitrate, in meat-cur- parts per million and not greater than ing preparations for the home curing of 200 parts per million, as measured in meat and meat products (including the loin muscle. poultry and wild game), with directions (c) Smoked chub shall be heated by a for use which limit the amount of so- controlled heat process which provides dium nitrite to not more than 200 parts a monitoring system positioned in as per million in the finished meat prod- many strategic locations in the smoke- uct, and the amount of sodium nitrate house as necessary to assure a contin- to not more than 500 parts per million uous temperature throughout each fish in the finished meat product. of at least 160 °F for a minimum of 30 (b) To assure safe use of the additive, minutes. in addition to the other information re- (d) The finished product shall be quired by the Act: cooled to a temperature of 50 °F or (1) The label of the additive or of a below within 3 hours after smoking and mixture containing the additive shall further cooled to a temperature of 38 °F bear: or below within 12 hours after smoking. (i) The name of the additive. A temperature of 38 °F or below shall (ii) A statement of the concentration be maintained during all subsequent of the additive in any mixture. storage and distribution. All shipping (2) If in a retail package intended for containers, retail packages, and ship- household use, the label and labeling of ping records shall indicate with appro- the additive, or of a mixture con- priate notice the perishable nature of taining the additive, shall bear ade- the product and specify that the prod- quate directions for use to provide a uct shall be held under refrigeration (38 final food product which complies with °F or below) until consumed. the limitations prescribed in paragraph (e) To assure safe use of the additive: (a) of this section. (1) The label and labeling of the addi- (3) If in a retail package intended for tive container shall bear, in addition to household use, the label of the addi- the other information required by the tive, or of a mixture containing the ad- Act, the name of the additive.

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(2) The label or labeling of the addi- used in food in accordance with the fol- tive container shall bear adequate di- lowing prescribed conditions: rections to assure use in compliance (a) The food additive has a melting with the provisions of this section. point of 149 °C–153 °C. (b) It is used as an antioxidant alone § 172.180 Stannous chloride. or in combination with other permitted The food additive stannous chloride antioxidants. may be safely used for color retention (c) The total antioxidant content of a in asparagus packed in glass, with lids food containing the additive will not lined with an inert material, in an exceed 0.02 percent of the oil or fat con- amount not to exceed 20 parts per million calculated as tin (Sn). tent of the food, including the essential (volatile) oil content of the food. § 172.185 TBHQ. The food additive TBHQ, which is the Subpart C—Coatings, Films and chemical 2-(1,1-dimethylethyl)-1,4-benz- Related Substances enediol (Chemical Abstracts Service Registry Number 1948–33–0), also known § 172.210 Coatings on fresh citrus fruit. as tertiary butylhydroquinone, may be Coatings may be applied to fresh cit- safely used in food in accordance with rus fruit for protection of the fruit in the following prescribed conditions: accordance with the following condi- (a) The food additive has a melting point of 126.5 °C–128.5 °C. tions: (b) It is used as an antioxidant alone (a) The coating is applied in the min- or in combination with BHA and/or imum amount required to accomplish BHT. the intended effect. (c) The total antioxidant content of a (b) The coating may be formulated food containing the additive will not from the following components, each exceed 0.02 percent of the oil or fat con- used in the minimum quantity required tent of the food, including the essential to accomplish the intended effect: (volatile) oil content of the food. (1) Substances generally recognized as safe for the purpose or previously § 172.190 THBP. sanctioned for the purpose. The food additive THBP (2,4,5-tri- (2) One or more of the following: hydroxybutyrophenone) may be safely

Component Limitations

Fatty acids ...... Complying with § 172.860. Oleic acid derived from tall oil fatty acids ...... Complying with § 172.862. Partially hydrogenated rosin ...... Catalytically hydrogenated to a maximum refractive index of 1.5012 at 100 °C. Color of WG or paler. Pentaerythritol ester of maleic anhydride-modi- Acid number of 134–145; drop-softening point of 127 °C–173 °C; saponifica- fied wood rosin. tion number of less than 280; and a color of M or paler. Do ...... Acid number of 176–186; drop-softening point of 110 °C–118 °C; saponification number of less than 280; and a color of M or paler. Polyethylene glycol ...... Complying with § 172.820. As a defoamer and dispersing adjuvant. Polyhydric alcohol diesters of oxidatively refined Complying with § 178.3770 of this chapter and having a dropping point of 77 (Gersthofen process) montan wax acids. to 83 °C (170.6 to 181.4 °F), as determined by ASTM Method D566–76 (Reapproved 1982), ‘‘Standard Test Method for Dropping Point of Lubri- cating Grease,’’ which is incorporated by reference (copies are available from the American Society for Testing and Materials, 1916 Race St., Phila- delphia, PA 19103, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408) using as a solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene- ethyl alcohol in a 2:1 ratio. Sodium lauryl sulfate ...... Complying with § 172.822. As a film former. Wood rosin ...... Color of K or paler.

(3) In lieu of the components listed in the following copolymer and one or paragraph (b) (2) and (4) of this section, more of the listed adjuvants.

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Component Limitations

Vinyl chloride-vinylidene chloride copolymer ...... As an aqueous dispersion containing a minimum of 75 percent water when applied. Polyethylene glycol ...... Complying with § 172.820. As a defoamer and dispersing adjuvant. Polyvinylpyrrolidone ...... As an adjuvant. Potassium persulfate ...... Do. Propylene glycol alginate ...... Do. Sodium decylbenzenesulfonate ...... Do.

(4) In lieu of the components listed in the following rosin derivative and ei- paragraph (b) (2) and (3) of this section, ther or both of the listed adjuvants:

Component Limitations

Calcium salt of partially dimerized rosin ...... Having a maximum drop-softening point of 197 °C and a color of H or paler. It is prepared by reaction with not more than 7 parts hydrated lime per 100 parts of partially dimerized rosin. The partially dimerized rosin is rosin that has been dimerized by sulfuric acid catalyst to a drop-softening point of 95 °C to 105 °C and a color of WG or paler. Petroleum naphtha ...... As adjuvant. Complying with § 172.250. Sperm oil ...... As adjuvant.

[42 FR 14491, Mar. 15, 1977; 49 FR 5747, Feb. 15, 1984, as amended at 51 FR 2693, Jan. 21, 1986; 52 FR 18911, May 20, 1987; 61 FR 14245, Apr. 1, 1996]

§ 172.215 Coumarone-indene resin. (c) It is used or intended for use as a protective coating for grapefruit, lem- The food additive coumarone-indene ons, limes, oranges, tangelos, and tan- resin may be safely used on grapefruit, gerines whereby the maximum amount lemons, limes, oranges, tangelos, and of the resin remaining on the fruit does tangerines in accordance with the fol- not exceed 200 parts per million on a lowing prescribed conditions: fresh-weight basis. (a) The food additive is manufactured (d) To assure safe use of the additive: by the polymerization of a crude, (1) The label of the market package heavy coal-tar solvent naphtha meet- or any intermediate premix of the ad- ing the following specifications: ditive shall bear, in addition to the (1) It is a mixture of indene, indan other information required by the act: (hydrindene), substituted benzenes, and (i) The name of the additive, cou- related compounds. marone-indene resin. (2) It contains no more than 0.25 per- (ii) A statement of the concentration cent tar bases. of the additive therein. (3) 95 percent distills in the range 167 (2) The label or accompanying label- °C–184 °C. ing shall bear adequate directions that, (b) The food additive meets the fol- if followed, will result in a finished lowing specifications: food not in conflict with the require- (1) Softening point, ring and ball: 126 ments of this section. ° C minimum as determined by ASTM [42 FR 14491, Mar. 15, 1977, as amended at 49 method E28–67 (Reapproved 1982), FR 10103, Mar. 19, 1984] ‘‘Standard Test Method for Softening Point by Ring-and-Ball Apparatus,’’ § 172.225 Methyl and ethyl esters of which is incorporated by reference. fatty acids produced from edible Copies may be obtained from the Amer- fats and oils. ican Society for Testing Materials, 1916 Methyl esters and ethyl esters of Race St., Philadelphia, PA 19103, or fatty acids produced from edible fats may be examined at the Office of the and oils may be safely used in food, Federal Register, 800 North Capitol subject to the following prescribed con- Street, NW., suite 700, Washington, DC ditions: 20408. (a) The additive consists of a mixture (2) Refractive index (n25/D) 1.63–1.64. of either methyl or ethyl esters of

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fatty acids produced from edible fats COMPONENT AND LIMITATIONS and oils and meets the following speci- Petroleum wax—Complying with § 172.886. fications: Not to exceed 50 percent by combined (1) Not less than 90 percent methyl or weight of the microcapsule and spice-fla- ethyl esters of fatty acids. voring substance. (2) Not more than 1.5 percent unsa- (b) The microcapsules produced from ponifiable matter. the components listed in paragraphs (a) (b) The additive is used or intended (1), (2), and (3) of this section may be for use at the level not to exceed 3 per- used for encapsulating authorized fla- cent by weight in an aqueous emulsion voring oils for use, in accordance with in dehydrating grapes to produce rai- good manufacturing practice, in foods sins, whereby the residue of the addi- for which standards of identity estab- tive on the raisins does not exceed 200 lished under section 401 of the Act do parts per million. not preclude such use, except that microcapsules formulated from compo- [57 FR 12711, Apr. 13, 1992] nents listed in paragraph (a)(2) of this section may be used only for encap- § 172.230 Microcapsules for flavoring substances. sulating lemon oil, distilled lime oil, orange oil, peppermint oil, and spear- Microcapsules may be safely used for mint oil for use in dry mixes for pud- encapsulating discrete particles of fla- dings and gelatin desserts. voring substances that are generally (c) The microcapsules produced from recognized as safe for their intended the components listed in paragraphs (a) use or are regulated under this part, in (1) and (4) of this section may be used accordance with the following condi- only for encapsulating authorized tions: spice-flavoring substances for use, in (a) The microcapsules may be formu- accordance with good manufacturing lated from the following components, practice, in frozen pizzas which are to each used in the minimum quantity re- be further processed by heat. Such piz- quired to accomplish the intended ef- zas shall bear labels or labeling includ- fect: ing adequate directions for use to en- (1) Substances generally recognized sure heating to temperatures which as safe for the purpose. will melt the wax to release the spice- (2) One or more of the following com- flavoring substances. ponents: [45 FR 48123, July 18, 1980]

COMPONENT AND LIMITATIONS § 172.235 Morpholine. Succinylated gelatin—Not to exceed 15 per- Morpholine may be safely used as a cent by combined weight of the microcapsule and flavoring oil. Succinic acid con- component of food, subject to the fol- tent of the gelatin is 4.5 to 5.5 percent. lowing restrictions. Arabinogalactan—Complying with § 172.610; (a) It is used as the salt(s) of one or as adjuvant. more of the fatty acids meeting the re- Silicon dioxide—Complying with § 172.480; as quirements of § 172.860, as a component adjuvant. of protective coatings applied to fresh fruits and vegetables. (3) In lieu of the components listed in (b) It is used at a level not in excess paragraph (a)(2) of this section, the fol- of that reasonably required to produce lowing components: its intended effect.

COMPONENT AND LIMITATIONS § 172.250 Petroleum naphtha. Glutaraldehyde—As cross-linking agent for Petroleum naphtha may be safely insolubilizing a coacervate of gum arabic used in food in accordance with the fol- and gelatin. lowing conditions: n-Octyl alcohol—As a defoamer. (a) The additive is a mixture of liquid (4) In lieu of the components listed in hydrocarbons, essentially paraffinic paragraphs (a)(2) and (3) of this section, and naphthenic in nature obtained the following component: from petroleum,

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(b) The additive is refined to meet under instrument operating conditions for the following specifications when sub- these absorbance measurements, the spectro- jected to the procedures described in photometer shall also meet the following this paragraph. performance requirements: (1) Boiling-point range: 175 °F–300 °F. Absorbance repeatability, ±0.01 at 0.4 absorb- (2) Nonvolatile residue: 0.002 gram ance. 1 ± per 100 milliliters maximum. Absorbance accuracy, 0.05 at 0.4 absorbance. (3) Ultraviolet absorbance limits, as Wavelength repeatability, ±0.2 millimicron. follows: Wavelength accuracy, ±1.0 millimicron. Maximum Ultraviolet lamp. Long wavelength (3400– absorb- 3800A°). ance per Wavelength (milli-microns) centimeter optical REAGENTS pathlength Isooctane (2,2,4-trimethylpentane). Use 180 280–289 ...... 0.15 milliliters in a 250-milliliter Erlenmeyer 290–299 ...... 13 flask, add 1 milliliter of purified n-hexa- 300–359 ...... 08 decane, insert the head assembly, allow ni- 360–400 ...... 02 trogen gas to flow into the inlet tube and connect the outlet tube to a solvent trap and ANALYTICAL SPECIFICATION FOR PETROLEUM vacuum line in such a way as to prevent any NAPHTHA back flow of condensate into the flask. The contents of the flask are evaporated on a GENERAL INSTRUCTIONS steam bath until 1 milliliter of residue re- All glassware should be scrupulously mains. Dissolve the 1 milliliter of hexa- cleaned to remove all organic matter such as decane residue in isooctane and make up to oil, grease, detergent residues, etc. Examine 25 milliliters. Determine the absorbance in a all glassware, including stoppers and stop- 5-centimeter path length cell compared to cocks, under ultraviolet light to detect any isooctane as reference. The absorbance residual fluorescent contamination. As a pre- should not exceed 0.01 per centimeter path cautionary measure, it is recommended prac- length between 280–400 mµ. If necessary, iso- tice to rinse all glassware with purified isooctane may be purified by passage through a octane immediately before use. No grease is column of activated silica gel (Grade 12, Da- to be used on stopcocks or joints. Great care vidson Chemical Co., Baltimore, Md., or to avoid contamination of petroleum naph- equivalent) or by distillation. tha samples in handling and to assure ab- Methyl alcohol, A.C.S. reagent grade. Use 10 sence of any extraneous material arising milliliters and proceed as with isooctane. from inadequate packaging is essential. Be- The absorbance per centimeter of path cause some of the polynuclear hydrocarbons length should be 0.00 between 280–400 mµ. sought in this test are very susceptible to Methyl alcohol may be purified by simple photo-oxidation, the entire procedure is to distillation or by refluxing in the presence of be carried out under subdued light. potassium hydroxide (10 grams/2 liters) and zinc dust (25 grams/2 liters) for 3 hours fol- APPARATUS lowed by distillation. n-Hexadecane, 99 percent olefin-free. Dilute Separatory funnels. 250-milliliter, and 2,000- 1.0 milliliter of n-hexadecane to 25 milliliters milliliter capacity, equipped with tetra- with isooctane and determine the absorbance fluoroethylene polymer stopcocks. Erlenmeyer flask. 125-milliliter with 24/40 standard taper neck. 1 As determined by procedure using potas- Evaporation flask. 250-milliliter capacity sium chromate for reference standard and all-glass flask equipped with 24/40 standard described in National Bureau of Standards taper stopper having inlet and outlet tubes Circular 484, Spectrophotometry, U.S. De- to permit passage of nitrogen across the sur- partment of Commerce, (1949). The accuracy face of the container liquid to be evaporated. is to be determined by comparison with the Condenser. 24/40 joints, fitted with drying standard values at 290, 345, and 400 milli- tube, length optional. microns. The procedure is incorporated by Spectrophotometric cells. Fused quartz cells, reference. Copies of the material incor- optical path length in the range of 5,000 cen- porated by reference are available from the timeters ±0.005 centimeter; also for checking Center for Food Safety and Applied Nutri- spectrophotometer performance only, optical tion (HFS–200), Food and Drug Administra- path length in the range 1,000 centimeter tion, 5100 Paint Branch Pkwy., College Park, ±0.005 centimeter. With distilled water in the MD 20740, or available for inspection at the cells, determine any absorbance difference. Office of the Federal Register, 800 North Cap- Spectrophotometer. Spectral range 250–400 itol Street, NW., suite 700, Washington, DC mµ with spectral slit width of 2 mµ or less; 20408.

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in a 5-centimeter cell compared to isooctane and transfer to the second separatory funnel. as reference between 280–400 mµ. The absorb- Shake the funnel for 1 minute. After separa- ance per centimeter path length shall not ex- tion of the layers, draw off the aqueous layer ceed 0.00 in this range. Purify, if necessary, into the first separatory funnel. Transfer the by percolation through activated silica gel isooctane in the second funnel to the volu- or by distillation. metric flask. Again wash the Erlenmeyer Sodium borohydride. 98 percent. flask with an additional 6 milliliters of iso- Water. All distilled water must be ex- octane, swirl, and transfer to the first sepa- tracted with isooctane before use. A series of ratory funnel. Shake the funnel for 1 minute. three successive extracts of 1.5 liters of dis- After separation of the layers, draw off the tilled water with 100-milliliter portions of aqueous layer and discard. Transfer the iso- isooctane is satisfactory. octane layer to the volumetric flask and adjust the volume to 25 milliliters of isooctane. PROCEDURE Mix the contents well, then transfer to the Determination of ultraviolet absorbance. Add first separatory funnel and wash twice with a 25-milliliter aliquot of the hydrocarbon 50-milliliter portions of distilled water. Dis- solvent together with 1 milliliter of hexa- card the aqueous layers after each wash. decane to the 125-milliliter Erlenmeyer Determine the ultraviolet absorbance of flask. While flushing with nitrogen, evapo- the isooctane extract in 5-centimeter path rate to 1 milliliter on a steam bath. Nitrogen length cells compared to isooctane as ref- ± is admitted through a 8 1-milliliter outer-di- erence between 280–400 mµ. Determine a rea- ± ameter tube, drawn out into a 2 1-centimeter gent blank concurrently with the sample, ± long and 1 0.5-millimeter inner-diameter using 25 milliliters of purified isooctane in- capillary tip. This is positioned so that the stead of a solvent sample and measuring the capillary tip extends 4 centimeters into the ultraviolet absorbance of the blank between flask. The nitrogen flow rate is such that the 280–400mµ. surface of the liquid is barely disturbed. After the volume is reduced to that of the 1 The reagent blank absorbance should not milliliter of hexadecane, the flask is left on exceed 0.04 per centimeter path length be- µ µ the steam bath for 10 more minutes before tween 280–289 m ; 0.020 between 290–359 m ; removing. Add 10 milliliters of purified iso- and 0.010 between 360–400 mµ. octane to the flask and reevaporate the solu- Determination of boiling-point range. Use tion to a 1-milliliter volume in the same ASTM method D86–82, ‘‘Standard Method for manner as described above, except do not Distillation of Petroleum Products,’’ which heat for an added 10 minutes. Repeat this op- is incorporated by reference. Copies may be eration twice more. Let the flask cool. obtained from the American Society for Add 10 milliliters of methyl alcohol and Testing Materials, 1916 Race St., Philadel- about 0.3 gram of sodium borohydride. (Mini- phia, PA 19103, or may be examined at the mize exposure of the borohydride to the at- Office of the Federal Register, 800 North Cap- mosphere; a measuring dipper may be used.) itol Street, NW., suite 700, Washington, DC Immediately fit a water-cooled condenser 20408. equipped with a 24/40 joint and with a drying Determination of nonvolatile residue. For hy- tube into the flask, mix until the sodium drocarbons boiling below 121 °C, determine borohydride is dissolved, and allow to stand the nonvolatile residue by ASTM method for 30 minutes at room temperature, with D1353–78, ‘‘Standard Test Method for Non- intermittent swirling. At the end of this volatile Matter in Volatile Solvents for Use time, disconnect the flask and evaporate the in Paint, Varnish, Lacquer, and Related methyl alcohol on the steam bath under ni- Products;’’ for those boiling above 121 °C, use trogen until sodium borohydride begins to ASTM method D381–80, ‘‘Standard Test drop out of solution. Remove the flask and Method for Existent Gum in Fuels by Jet let it cool. Evaporation,’’ which methods are incor- Add 6 milliliters of isooctane to the flask porated by reference. Copies may be obtained and swirl to wash the crystalline slurry. from the American Society for Testing Ma- Carefully transfer the isooctane extract to a terials, 1916 Race St., Philadelphia, PA 19103, 250-milliliter separatory funnel. Dissolve the or may be examined at the Office of the Fed- crystals in the flask with about 25 milliliters eral Register, 800 North Capitol Street, NW., of distilled water and pour this also into the suite 700, Washington, DC 20408. separatory funnel. Adjust the water volume in the separatory funnel to about 100 milli- (c) Petroleum naphtha containing liters and shake for 1 minute. After separa- antioxidants shall meet the specified tion of the layers, draw off the aqueous layer ultraviolet absorbance limits after cor- into a second 250-milliliter separatory fun- rection for any absorbance due to the nel. Transfer the hydrocarbon layer in the first funnel to a 25-milliliter volumetric antioxidants. Petroleum naphtha may flask. contain antioxidants authorized for use Carefully wash the Erlenmeyer flask with in food in an amount not to exceed an additional 6 milliliters of isooctane, swirl, that reasonably required to accomplish

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the intended effect or to exceed any § 172.270 Sulfated butyl oleate. prescribed limitations. Sulfate butyl oleate may be safely (d) Petroleum naphtha is used or in- used in food, subject to the following tended for use as a solvent in protec- prescribed conditions: tive coatings on fresh citrus fruit in (a) The additive is prepared by sul- compliance with § 172.210. fation, using concentrated sulfuric [42 FR 14491, Mar. 15, 1977, as amended at 47 acid, of a mixture of butyl esters pro- FR 11835, Mar. 19, 1982; 49 FR 10104, Mar. 19, duced by transesterification of an edi- 1984; 54 FR 24896, June 12, 1989] ble vegetable oil using 1-butanol. Fol- lowing sulfation, the reaction mixture § 172.255 Polyacrylamide. is washed with water and neutralized with aqueous sodium or potassium hy- Polyacrylamide containing not more droxide. Prior to sulfation, the butyl than 0.2 percent of acrylamide mon- oleate reaction mixture meets the fol- omer may be safely used as a film lowing specifications: former in the imprinting of soft-shell (1) Not less than 90 percent butyl ole- gelatin capsules when the amount used ate. is not in excess of the minimum re- (2) Not more than 1.5 percent unsa- quired to produce the intended effect. ponifiable matter. (b) The additive is used or intended § 172.260 Oxidized polyethylene. for use at a level not to exceed 2 per- Oxidized polyethylene may be safely cent by weight in an aqueous emulsion used as a component of food, subject to in dehydrating grapes to produce rai- the following restrictions: sins, whereby the residue of the addi- (a) Oxidized polyethylene is the basic tive on the raisins does not exceed 100 resin produced by the mild air oxida- parts per million. tion of polyethylene. The polyethylene [57 FR 12711, Apr. 13, 1992] used in the oxidation process conforms to the density, maximum n-hexane ex- § 172.275 Synthetic paraffin and suc- tractable fraction, and maximum xy- cinic derivatives. lene soluble fraction specifications pre- Synthetic paraffin and succinic described in item 2.3 of the table in rivatives identified in this section may § 177.1520(c) of this chapter. The be safely used as a component of food, oxidized polyethylene has a minimum subject to the following restrictions: number average molecular weight of (a) The additive is prepared with 50 1,200, as determined by high tempera- percent Fischer-Tropsch process syn- ture vapor pressure osmometry; con- thetic paraffin, meeting the definition tains a maximum of 5 percent by and specifications of § 172.615, and 50 weight of total oxygen; and has an acid percent of such synthetic paraffin to value of 9 to 19. which is bonded succinic anhydride and succinic acid derivatives of isopropyl (b) The additive is used or intended alcohol, polyethylene glycol, and poly- for use as a protective coating or com- propylene glycol. It consists of a mix- ponent of protective coatings for fresh ture of the Fischer-Tropsch process avocados, bananas, beets, coconuts, paraffin (alkane), alkyl succinic anhy- eggplant, garlic, grapefruit, lemons, dride, alkyl succinic anhydride iso- limes, mango, muskmelons, onions, or- propyl half ester, dialkyl succinic an- anges, papaya, peas (in pods), pine- hydride polyethylene glycol half ester, apple, plantain, pumpkin, rutabaga, and dialkyl succinic anhydride poly- squash (acorn), sweetpotatoes, tan- propylene glycol half ester, where the gerines, turnips, watermelon, Brazil alkane (alkyl) has a chain length of 30– nuts, chestnuts, filberts, hazelnuts, pe- 70 carbon atoms and the polyethylene cans, and walnuts (all nuts in shells). and polypropylene glycols have molec- (c) The additive is used in accordance ular weights of 600 and 260, respec- with good manufacturing practice and tively. in an amount not to exceed that re- (b) The additive meets the following quired to produce the intended effect. specifications: Molecular weight, 880– 930; melting point, 215°–217 °F; acid

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number, 43–47; and saponification num- § 172.315 Nicotinamide-ascorbic acid ber, 75–78. complex. (c) It is used or intended for use as a Nicotinamide-ascorbic acid complex protective coating or component of may be safely used in accordance with protective coatings for fresh grape- the following prescribed conditions: fruit, lemons, limes, muskmelons, or- (a) The additive is the product of the anges, sweetpotatoes, and tangerines. controlled reaction between ascorbic (d) It is used in an amount not to ex- acid and nicotinamide, melting in the ceed that required to produce the in- range 141 °C to 145 °C. tended effect. (b) It is used as a source of ascorbic acid and nicotinamide in multivitamin § 172.280 Terpene resin. preparations.

The food additive terpene resin may § 172.320 Amino acids. be safely used in accordance with the following prescribed conditions: The food additive amino acids may be safely used as nutrients added to (a) The food additive is the beta- foods in accordance with the following pinene polymer obtained by polym- conditions: erizing terpene hydrocarbons derived (a) The food additive consists of one from wood. It has a softening point of or more of the following individual ° ° 112 C–118 C, as determined by ASTM amino acids in the free, hydrated or an- method E28–67 (Reapproved 1982), hydrous form or as the hydrochloride, ‘‘Standard Test Method for Softening sodium or potassium salts: Point By Ring-and-Ball Apparatus,’’ which is incorporated by reference. L-Alanine Copies may be obtained from the Amer- L-Arginine L-Asparagine ican Society for Testing Materials, 1916 L-Aspartic acid Race St., Philadelphia, PA 19103, or L-Cysteine may be examined at the Office of the L-Cystine Federal Register, 800 North Capitol L-Glutamic acid Street, NW., suite 700, Washington, DC L-Glutamine 20408. Aminoacetic acid (glycine) L-Histidine (b) It is used or intended for use as L-Isoleucine follows: L-Leucine (1) As a moisture barrier on soft gela- L-Lysine tin capsules in an amount not to ex- DL-Methionine (not for infant foods) ceed 0.07 percent of the weight of the L-Methionine L-Phenylalanine capsule. L-Proline (2) As a moisture barrier on powders L-Serine of ascorbic acid or its salts in an L-Threonine amount not to exceed 7 percent of the L-Tryptophan weight of the powder. L-Tyrosine L-Valine [42 FR 14491, Mar. 15, 1977, as amended at 49 (b) The food additive meets the fol- FR 10104, Mar. 19, 1984] lowing specifications: (1) As found in ‘‘Food Chemicals Subpart D—Special Dietary and Codex,’’ National Academy of Sciences/ Nutritional Additives National Research Council (NAS/NRC), 3d Ed. (1981), which is incorporated by § 172.310 Aluminum nicotinate. reference (copies may be obtained from Aluminum nicotinate may be safely the National Academy Press, 2101 Con- used as a source of niacin in foods for stitution Ave. NW., Washington, DC special dietary use. A statement of the 20418, or may be examined at the Office concentration of the additive, ex- of the Federal Register, 800 North Cap- pressed as niacin, shall appear on the itol Street, NW., suite 700, Washington, label of the food additive container or DC 20408) for the following: on that of any intermediate premix L-Alanine prepared therefrom. L-Arginine

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L-Arginine Monohydrochloride (2) The additive(s) results in a pro- L-Cysteine Monohydrochloride tein efficiency ratio (PER) of protein L-Cystine in the finished ready-to-eat food equiv- Aminoacetic acid (glycine) alent to casein as determined by the L-Leucine DL-Methionine method specified in paragraph (d) of L-Methionine this section. L-Tryptophan (3) Each amino acid (or combination L-Phenylalanine of the minimum number necessary to L-Proline achieve a statistically significant in- L-Serine crease) added results in a statistically L-Threonine significant increase in the PER as de- Glutamic Acid Hydrochloride termined by the method described in L-Isoleucine L-Lysine Monohydrochloride paragraph (d) of this section. The min- Monopotassium L-glutamate imum amount of the amino acid(s) to L-Tyrosine achieve the desired effect must be used L-Valine and the increase in PER over the primarily-intact naturally occurring pro- (2) As found in ‘‘Specifications and tein in the food must be substantiated Criteria for Biochemical Compounds,’’ as a statistically significant difference NAS/NRC Publication, 3rd Ed. (1972), with at least a probability (P) value of which is incorporated by reference less than 0.05. (copies are available from the Center (4) The amount of the additive added for Food Safety and Applied Nutrition for nutritive purposes plus the amount (HFS–200), Food and Drug Administra- naturally present in free and combined tion, 5100 Paint Branch Pkwy., College (as protein) form does not exceed the Park, MD 20740, or available for inspec- following levels of amino acids ex- tion at the Office of the Federal Reg- pressed as percent by weight of the ister, 800 North Capitol Street, NW., total protein of the finished food: suite 700, Washington, DC 20408) for the following: Percent by weight of L-Asparagine total pro- L-Aspartic acid tein (expressed as L-Glutamine free amino L-Histidine acid)

(c) The additive(s) is used or intended L-Alanine ...... 6.1 for use to significantly improve the bi- L-Arginine ...... 6.6 L-Aspartic acid (including L-asparagine) ...... 7.0 ological quality of the total protein in L-Cystine (including L-cysteine) ...... 2.3 a food containing naturally occurring L-Glutamic acid (including L-glutamine) ...... 12.4 primarily-intact protein that is consid- Aminoacetic acid (glycine) ...... 3.5 ered a significant dietary protein L-Histidine ...... 2.4 L-Isoleucine ...... 6.6 source, provided that: L-Leucine ...... 8.8 (1) A reasonable daily adult intake of L-Lysine ...... 6.4 the finished food furnishes at least 6.5 L- and DL-Methionine ...... 3.1 L-Phenylalanine ...... 5.8 grams of naturally occurring primarily L-Proline ...... 4.2 intact protein (based upon 10 percent of L-Serine ...... 8.4 the daily allowance for the ‘‘reference’’ L-Threonine ...... 5.0 L-Tryptophan ...... 1.6 adult male recommended by the Na- L-Tyrosine ...... 4.3 tional Academy of Sciences in ‘‘Rec- L-Valine ...... 7.4 ommended Dietary Allowances,’’ NAS Publication No. 1694, 7th Ed. (1968), (d) Compliance with the limitations which is incorporated by reference. concerning PER under paragraph (c) of Copies are available from the Center this section shall be determined by the for Food Safety and Applied Nutrition method described in sections 43.212– (HFS–200), Food and Drug Administra- 43.216, ‘‘Official Methods of Analysis of tion, 5100 Paint Branch Pkwy., College the Association of Official Analytical Park, MD 20740, or available for inspec- Chemists,’’ 13th Ed. (1980), which is in- tion at the Office of the Federal Reg- corporated by reference. Copies may be ister, 800 North Capitol Street, NW., obtained from the Association of Offi- suite 700, Washington, DC 20408. cial Analytical Chemists International,

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481 North Frederick Ave., suite 500, § 172.325 Bakers yeast protein. Gaithersburg, MD 20877–2504, or may be Bakers yeast protein may be safely examined at the Office of the Federal used in food in accordance with the fol- Register, 800 North Capitol Street, lowing conditions: NW., suite 700, Washington, DC 20408. (a) Bakers yeast protein is the insol- Each manufacturer or person employ- uble proteinaceous material remaining ing the additive(s) under the provisions after the mechanical rupture of yeast of this section shall keep and maintain cells of Saccharomyces cerevisiae and re- throughout the period of his use of the moval of whole cell walls by cen- additive(s) and for a minimum of 3 trifugation and separation of soluble years thereafter, records of the tests cellular materials. required by this paragraph and other (b) The additive meets the following records required to assure effectiveness specifications on a dry weight basis: and compliance with this regulation (1) Zinc salts less than 500 parts per and shall make such records available million (ppm) as zinc. upon request at all reasonable hours by (2) Nucleic acid less than 2 percent. any officer or employee of the Food (3) Less than 0.3 ppm arsenic, 0.1 ppm and Drug Administration, or any other cadmium, 0.4 ppm lead, 0.05 ppm mer- officer or employee acting on behalf of cury, and 0.3 ppm selenium. the Secretary of Health and Human (c) The viable microbial content of Services and shall permit such officer the finished ingredient is: or employee to conduct such inven- tories of raw and finished materials on (1) Less than 10,000 organisms/gram by aerobic plate count. hand as he deems necessary and otherwise to check the correctness of such (2) Less than 10 yeasts and molds/ gram. records. (3) Negative for Salmonella, E. coli, (e) To assure safe use of the additive, coagulase positive Staphylococci, Clos- the label and labeling of the additive tridium perfringens, Clostridium botu- and any premix thereof shall bear, in linum, or any other recognized micro- addition to the other information re- bial pathogen or any harmful microbial quired by the Act, the following: toxin. (1) The name of the amino acid(s) (d) The ingredient is used in food as contained therein including the spe- a nutrient supplement as defined in cific optical and chemical form. § 170.3(o)(20) of this chapter. (2) The amounts of each amino acid contained in any mixture. § 172.330 Calcium pantothenate, cal- (3) Adequate directions for use to cium chloride double salt. provide a finished food meeting the The food additive calcium chloride limitations prescribed by paragraph (c) double salt of calcium pantothenate of this section. may be safely used in foods for special (f) The food additive amino acids dietary uses in accordance with good added as nutrients to special dietary manufacturing practice and under the foods that are intended for use solely following prescribed conditions: under medical supervision to meet nu- (a) The food additive is of the d (dex- tritional requirements in specific med- trorotatory) or the dl (racemic) form. ical conditions and comply with the re- (b) To assure safe use of the additive, quirements of part 105 of this chapter the label and labeling of the food addi- are exempt from the limitations in tive container, or that of any inter- paragraphs (c) and (d) of this section mediate premixes prepared therefrom, and may be used in such foods at levels shall bear, in addition to the other in- not to exceed good manufacturing formation required by the Act, the fol- practices. lowing: [42 FR 14491, Mar. 15, 1977; 42 FR 56728, Oct. (1) The name of the additive ‘‘cal- 28, 1977, as amended at 47 FR 11836, Mar. 19, cium chloride double salt of d-calcium 1982; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, pantothenate’’ or ‘‘calcium chloride June 12, 1989; 59 FR 14550, Mar. 29, 1994; 61 FR double salt of dl-calcium panto- 14480, Apr. 2, 1996] thenate’’, whichever is appropriate.

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(2) A statement of the appropriate Free Samples (20)—Official Final Ac- concentration of the additive, ex- tion. pressed as pantothenic acid. (2) Moisture content shall not be more than 10 percent by weight of the § 172.335 D-Pantothenamide. final product, as determined by the The food additive D-pantothenamide method described in section 24.003, Air as a source of pantothenic acid activ- Drying (1)—Official First Action. ity, may be safely used in foods for spe- (3) Fat content shall not be more cial dietary use in an amount not in than 0.5 percent by weight of the final excess of that reasonably required to product, as determined by the method produce its intended effect. described in section 24.005, Crude Fat or Ether Extract—Official Final Ac- § 172.340 Fish protein isolate. tion. (a) The food additive fish protein iso- (4) Solvent residues in the final prod- late may be safely used as a food sup- uct shall not be more than 5 parts per plement in accordance with the fol- million of hexane and 3.5 percent eth- lowing prescribed conditions: anol by weight. (1) The additive shall consist prin- [46 FR 38072, July 24, 1981, as amended at 47 cipally of dried fish protein prepared FR 53344, Nov. 26, 1982; 54 FR 24897, June 12, from the edible portions of fish after 1989] removal of the heads, fins, tails, bones, scales, viscera, and intestinal contents. § 172.345 Folic acid (folacin). (2) The additive shall be derived only Folic acid (CAS Reg. No. 59–30–3), from species of bony fish that are gen- also known as folacin or folate, may be erally recognized by qualified sci- safely used in food as a nutrient in ac- entists as safe for human consumption cordance with the following prescribed and that can be processed as prescribed conditions: to meet the required specifications. (a) Folic acid is the chemical N-[4- (3) Only wholesome fresh fish other- [[(2-amino-1,4-dihydro-4-oxo-6-pteri- wise suitable for human consumption dinyl)methyl]amino]benzoyl]-L-glu- may be used. The fish shall be handled tamic acid. expeditiously under sanitary condi- (b) Folic acid meets the specifications. These conditions shall be in actions of the ‘‘Food Chemicals Codex,’’ cordance with recognized good manu- 4th ed. (1996), pp. 157–158, which is in- facturing practice for fish to be used as corporated by reference in accordance human food. with 5 U.S.C. 552(a) and 1 CFR part 51. (4) The additive shall be prepared by Copies are available from the National extraction with hexane and food-grade Academy Press, Box 285, 2101 Constitu- ethanol to remove fat and moisture. tion Ave. NW., Washington, DC 20055 Solvent residues shall be reduced by (Internet address http://www.nap.edu), drying. or may be examined at the Center for (b) The food additive meets the fol- Food Safety and Applied Nutrition’s lowing specifications: (Where methods Library, Food and Drug Administra- of determination are specified, they are tion, 5100 Paint Branch Pkwy., College Association of Official Analytical Park, MD 20740, or at the Office of the Chemists Methods, 13th ed., 1980, which Federal Register, 800 North Capitol St. are incorporated by reference). 1 × NW., suite 700, Washington, DC. (1) Protein content, as N 6.25, shall (c) Folic acid may be added to foods not be less than 90 percent by weight of subject to a standard of identity estab- the final product, as determined by the lished under section 401 of the Federal method described in section 2.057, Im- Food, Drug, and Cosmetic Act (the act) proved Kjeldahl Method for Nitrate- when the standard of identity specifically provides for the addition of folic 1 Copies are available from: Association of acid. Official Analytical Chemists International, (d) Folic acid may be added, at levels 481 North Frederick Ave., suite 500, Gaithers- µ burg, MD 20877–2504, or examined at the Of- not to exceed 400 micrograms ( g) per fice of the Federal Register, 800 North Cap- serving, to breakfast cereals, as defined itol Street, NW., suite 700, Washington, DC under § 170.3(n)(4) of this chapter, and 20408. to corn grits at a level such that each

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pound of corn grits contains not more amount reasonably required to accom- than 1.0 milligram of folic acid. plish the intended effect. (e) Folic acid may be added to infant (c) Ferrous fumarate is used as a formula in accordance with section source of iron in foods for special die- 412(i)(1) of the act or with regulations tary use, when the use is consistent issued under section 412(i)(2) of the act with good nutrition practice. which are codified in § 107.100 of this chapter. § 172.365 Kelp. (f) Folic acid may be added to a med- Kelp may be safely added to a food as ical food, as defined in section 5(b)(3) of a source of the essential mineral io- the Orphan Drug Act (21 U.S.C. dine, provided the maximum intake of 360ee(b)(3)), at levels not to exceed the the food as may be consumed during a amount necessary to meet the distinc- period of one day, or as directed for use tive nutritional requirements of the in the case of a dietary supplement, disease or condition for which the food will not result in daily ingestion of the is formulated. additive so as to provide a total (g) Folic acid may be added to food amount of iodine in excess of 225 for special dietary use at levels not to micrograms for foods labeled without exceed the amount necessary to meet reference to age or physiological state; the special dietary needs for which the and when age or the conditions of preg- food is formulated. nancy or lactation are specified, in ex- (h) Folic acid may be added to foods cess of 45 micrograms for infants, 105 represented as meal-replacement prod- micrograms for children under 4 years ucts, in amounts not to exceed: of age, 225 micrograms for adults and (1) Four hundred µg per serving if the children 4 or more years of age, and 300 food is a meal-replacement that is rep- micrograms for pregnant or lactating resented for use once per day; or women. The food additive kelp is the (2) Two hundred µg per serving if the dehydrated, ground product prepared food is a meal-replacement that is rep- from Macrocystis pyrifera, Laminaria resented for use more than once per digitata, Laminaria saccharina, and Lam- day. inaria cloustoni. [61 FR 8807, Mar. 5, 1996, as amended at 61 FR 27779, June 3, 1996; 64 FR 1758, Jan. 12, 1999] § 172.370 Iron-choline citrate complex. § 172.350 Fumaric acid and salts of fu- Iron-choline citrate complex made by maric acid. reacting approximately equimolecular quantities of ferric hydroxide, choline, Fumaric acid and its calcium, fer- and citric acid may be safely used as a rous, magnesium, potassium, and so- source of iron in foods for special die- dium salts may be safely used in food tary use. in accordance with the following prescribed conditions: § 172.372 N-Acetyl-L-methionine. (a) The additives meet the following specifications: The food additive N-acetyl-L-methio- (1) Fumaric acid contains a minimum nine may be safely added to food (ex- of 99.5 percent by weight of fumaric cept infant foods and foods containing acid, calculated on the anhydrous added nitrites/nitrates) as a source of basis. L-methionine for use as a nutrient in (2) The calcium, magnesium, potas- accordance with the following condi- sium, and sodium salts contain a min- tions: imum of 99 percent by weight of the re- (a) N-Acetyl-L-methionine (Chemical spective salt, calculated on the anhy- Abstracts Service Registry No. 65–82–7) drous basis. Ferrous fumarate contains is the derivative of the amino acid me- a minimum of 31.3 percent total iron thionine formed by addition of an and not more than 2 percent ferric acetyl group to the alpha-amino group iron. of methionine. It may be in the free, (b) With the exception of ferrous fu- hydrated or anhydrous form, or as the marate, fumaric acid and the named sodium or potassium salts. salts are used singly or in combination (b) The additive meets the following in food at a level not in excess of the specifications:

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(1) Purity assay, on a dry basis: Min- the Association of Official Analytical imum 99 percent. Chemists,’’ 13th Ed. (1980), which is in- (2) Residue on ignition: Maximum 0.1 corporated by reference. Copies may be percent. obtained from the Association of Offi- (3) Specific optical rotation cial Analytical Chemists International, 20 [alpha] D: Between ¥19° and ¥23°. 481 North Frederick Ave., suite 500, (4) The additive may contain residues Gaithersburg, MD 20877–2504, or may be of not more than 500 ppm ethyl ace- examined at the Office of the Federal tate; 50 ppm ethyl alcohol; 10 ppm Register, 800 North Capitol Street, methyl alcohol; and 10 ppm acetone, NW., suite 700, Washington, DC 20408. when used as processing solvents. Each manufacturer or person employ- (c) The additive is used or intended ing the additive under the provisions of for use as a source of L-methionine to this section shall keep and maintain improve significantly the biological throughout the period of use of the ad- quality of the total protein in a food ditive and for a minimum of 3 years containing naturally occurring pri- thereafter, records of the tests required marily intact vegetable protein that is by this paragraph and other records re- considered a significant dietary protein quired to assure effectiveness and com- source, provided that: pliance with this regulation. Those (1) A reasonable daily adult intake of the finished food furnishes at least 6.5 records shall be made available upon grams of naturally occurring primarily request at all reasonable hours by any intact vegetable protein. officer or employee acting on behalf of (2) The additive results in a protein the Secretary of Health and Human efficiency ratio (PER) of protein in the Services. Those officers or employees finished ready-to-eat food equivalent shall be permitted to conduct inven- to casein as determined by the method tories of raw and finished materials on specified in paragraph (d) of this sec- hand as are deemed necessary to verify tion. the records. (3) The use of the additive results in (e) To assure safe use of the additive, a statistically significant increase in the label and labeling of the additive the PER as determined by the method and any premix thereof shall bear, in described in paragraph (d) of this sec- addition to the other information re- tion. The minimum amount of the ad- quired by the Act, the following: ditive to achieve the desired effect (1) The name of the additive con- must be used, and the increase in PER tained therein. over the primarily intact naturally oc- (2) The amounts of additive and each curring vegetable protein in the food amino acid contained in any mixture. must be substantiated as a statis- (3) Adequate directions for use to tically significant difference with at provide a finished food meeting the least a probability (P) value of less limitations prescribed by paragraph (c) than 0.05. of this section. (4) The amount of the additive added (f) When the food additive is added as for nutritive purpose shall not exceed a nutrient to special dietary foods that the level that will provide a total of 3.1 are intended for use solely under med- percent L- and DL-methionine (ex- ical supervision to meet nutritional re- pressed as the free amino acid) by quirements in specific medical condi- weight of the total protein of the fin- tions and these foods comply with the ished food, including the amount natu- requirements of part 105 of this chap- rally present in free and combined (as ter, the food additive is exempt from protein) form. the limitations in paragraphs (c)(1) (5) The additive shall not be added to infant foods or to foods containing through (4) and (d) of this section and added nitrites/nitrates. may be used in those foods at levels (d) Compliance with the limitations not to exceed good manufacturing concerning PER under paragraph (c) of practices. the section shall be determined by the [43 FR 27784, June 27, 1978, as amended at 46 method described in sections 43.212– FR 59968, Dec. 8, 1981; 49 FR 10104, Mar. 19, 43.216, ‘‘Official Methods of Analysis of 1984; 54 FR 24897, June 12, 1989]

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§ 172.375 Potassium iodide. Drug Administration, 5100 Paint The food additive potassium iodide Branch Pkwy., College Park, MD 20740, may be safely used in accordance with or the Office of the Federal Register, the following prescribed conditions: 800 North Capitol St. NW., suite 700, (a) Potassium iodide may be safely Washington, DC. added to a food as a source of the es- (c) Vitamin D3 may be added, at lev- sential mineral iodine, provided the els not to exceed 100 International maximum intake of the food as may be Units (IU) per serving, to 100 percent consumed during a period of one day, fruit juices, as defined under or as directed for use in the case of a § 170.3(n)(35) of this chapter, excluding dietary supplement, will not result in fruit juices that are specially formu- daily ingestion of the additive so as to lated or processed for infants, that are provide a total amount of iodine in ex- fortified with greater than 33 percent cess of 225 micrograms for foods labeled of the Recommended Daily Intake without reference to age or physio- (RDI) of calcium per Reference Amount logical state; and when age or the con- Customarily Consumed (RACC). ditions of pregnancy or lactation are (d) Vitamin D3 may be added, at lev- specified, in excess of 45 micrograms els not to exceed 100 IU per serving, to for infants, 105 micrograms for children fruit drinks, as defined under under 4 years of age, 225 micrograms § 170.3(n)(35) of this chapter, excluding for adults and children 4 or more years fruit drinks that are specially formu- of age, and 300 micrograms for preg- lated or processed for infants, that are nant or lactating women. fortified with greater than 10 percent (b) To assure safe use of the additive, of the RDI of calcium per RACC. in addition to the other information re- [68 FR 9003, Feb. 27, 2003] quired by the Act, the label of the additive shall bear: § 172.385 Whole fish protein con- (1) The name of the additive. centrate. (2) A statement of the concentration The food additive whole fish protein of the additive in any mixture. concentrate may be safely used as a food supplement in accordance with § 172.380 Vitamin D3. the following prescribed conditions: The food additive may be used safely (a) The additive is derived from in foods as a nutrient supplement de- whole, wholesome hake and hakelike fined under § 170.3(o)(20) of this chapter fish, herring of the genera Clupea, men- in accordance with the following pre- haden, and anchovy of the species En- scribed conditions: graulis mordax, handled expeditiously (a) Vitamin D3, also known as chole- and under sanitary conditions in ac- calciferol, is the chemical 9,10- cordance with good manufacturing seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. practices recognized as proper for fish Vitamin D3 occurs in and is isolated that are used in other forms for human from fish liver oils. It also is manufac- food. tured by ultraviolet irradiation of 7-de- (b) The additive consists essentially hydrocholesterol produced from choles- of a dried fish protein processed from terol and is purified by crystallization. the whole fish without removal of (b) Vitamin D3 meets the specifica- heads, fins, tails, viscera, or intestinal tions of the Food Chemicals Codex, 4th contents. It is prepared by solvent ex- ed. (1996), p. 434, which is incorporated traction of fat and moisture with iso- by reference. The Director of the Office propyl alcohol or with ethylene dichlo- of the Federal Register approves this ride followed by isopropyl alcohol, ex- incorporation by reference in accord- cept that the additive derived from ance with 5 U.S.C. 552(a) and 1 CFR herring, menhaden and anchovy is pre- part 51. You may obtain copies from pared by solvent extraction with iso- the National Academy Press, 2101 Con- propyl alcohol alone. Solvent residues stitution Ave. NW., Washington, DC are reduced by conventional heat dry- 20418 (Internet address http:// ing and/or microwave radiation and www.nap.edu. Copies may be examined there is a partial removal of bone. at the Center for Food Safety and Ap- (c) The food additive meets the fol- plied Nutrition’s Library, Food and lowing specifications:

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(1) Protein content (N × 6.25) shall this source shall not exceed 20 grams not be less than 75 percent by weight of per day (about one heaping table- the final product, as determined by the spoon). method described in section 2.057 in (e) When the additive is used as a ‘‘Official Methods of Analysis of the protein supplement in manufactured Association of Official Analytical food, the total fluoride content (ex- Chemists’’ (AOAC), 13th Ed. (1980). Pro- pressed as F) of the finished food shall tein quality shall not be less than 100, not exceed 8 ppm based on the dry as determined by the method described weight of the food product. in sections 43.212–43.216 of the AOAC. (f) To assure safe use of the additive, The 13th Ed. is incorporated by refin addition to the other information re- erence, and copies may be obtained quired by the Act: from the Association of Official Ana- (1) The label of consumer-sized or lytical Chemists International, 481 bulk containers of the additive shall North Frederick Ave., suite 500, Gai- bear the name ‘‘whole fish protein con- thersburg, MD 20877–2504, or may be ex- centrate’’. amined at the Office of the Federal (2) The label or labeling of containers Register, 800 North Capitol Street, of the additive shall bear adequate di- NW., suite 700, Washington, DC 20408. rections for use to comply with the (2) Moisture content shall not exceed limitations prescribed by paragraphs 10 percent by weight of the final prod- (d) and (e) of this section. uct, as determined by the method de- (3) Labels of manufactured foods con- scribed in section 24.003 of the AOAC. taining the additive shall bear, in the See paragraph (c)(1) of this section for ingredient statement, the name of the availability of the material incor- additive, ‘‘whole fish protein con- porated by reference. centrate’’ in the proper order of de- (3) Fat content shall not exceed 0.5 creasing predominance in the finished percent by weight of the final product, food. as determined by the method described in section 24.005 of the AOAC. See para- [42 FR 14491, Mar. 15, 1977, as amended at 49 graph (c)(1) of the this section for FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989] availability of the material incorporated by reference. § 172.395 Xylitol. (4) The additive may contain residues of isopropyl alcohol and ethylene di- Xylitol may be safely used in foods chloride not in excess of 250 parts per for special dietary uses, provided the million and 5 parts per million, respec- amount used is not greater than that tively, when used as solvents in the ex- required to produce its intended effect. traction process. (5) Microwave radiation meeting the § 172.399 Zinc methionine sulfate. requirements of § 179.30 of this chapter Zinc methionine sulfate, CAS Reg. may be used to reduce residues of the No. 56329–42–1, may be safely used in solvents used in the extraction process. accordance with the following pre- (6) The additive shall contain not in scribed conditions: excess of 100 parts per million fluorides (a) The additive is the product of the (expressed as F). reaction between equimolar amounts of (7) The additive shall be free of Esch- zinc sulfate and DL-methionine in puri- erichia coli and pathogenic organisms, fied water. including Salmonella, and shall have a (b) The additive meets the following total bacterial plate count of not more specifications: than 10,000 per gram. Zinc content—19 to 22 percent. (8) The additive shall have no more C5H11NO2S ‘‘DL-methionine’’—46 to 50 per- than a faint characteristic fish odor cent. and taste. Cadmium—not more than 0.05 part per mil- (d) When the additive is used or in- lion. tended for use in the household as a (c) The additive is used in tablet form protein supplement in food for regular as a source of dietary zinc. consumption by children up to 8 years of age, the amount of the additive from [46 FR 58297, Dec. 1, 1981]

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Subpart E—Anticaking Agents (c) It is used or intended for use as a stabilizer in the production of beer, and § 172.410 Calcium silicate. is removed from the beer by filtration Calcium silicate, including synthetic prior to final processing. calcium silicate, may be safely used in (d) It is used or intended for use as an food in accordance with the following adsorbent for dl-a-tocopheryl acetate prescribed conditions: and pantothenyl alcohol in tableted (a) It is used as an anticaking agent foods for special dietary use, in an in food in an amount not in excess of amount not greater than that required that reasonably required to produce its to accomplish the intended physical or intended effect. technical effect. (b) It will not exceed 2 percent by weight of the food, except that it may § 172.490 Yellow prussiate of soda. be present up to 5 percent by weight of (a) The food additive yellow prussiate baking powder. of soda (sodium ferrocyanide decahydrate; Na Fe(CN) ·10H O contains a § 172.430 Iron ammonium citrate. 4 6 2 minimum of 99 percent by weight of so- Iron ammonium citrate may be safe- dium ferrocyanide decahydrate. ly used in food in accordance with the (b) The additive is used or intended following prescribed conditions: for use as an anticaking agent in salt (a) The additive is the chemical and as an adjuvant in the production of green ferric ammonium citrate. dendritic crystals of salt in an amount (b) The additive is used, or intended needed to produce its intended effect for use as an anticaking agent in salt for human consumption so that the but not in excess of 13 parts per million level of iron ammonium citrate does calculated as anhydrous sodium ferro- not exceed 25 parts per million (0.0025 cyanide. percent) in the finished salt. [42 FR 14491, Mar. 15, 1977, as amended at 58 (c) To assure safe use of the additive FR 17098, Apr. 1, 1993] the label or labeling of the additive shall bear, in addition to the other in- Subpart F—Flavoring Agents and formation required by the Act: (1) The name of the additive. Related Substances (2) Adequate directions to provide a § 172.510 Natural flavoring substances final product that complies with the and natural substances used in con- limitations prescribed in paragraph (b) junction with flavors. of this section. Natural flavoring substances and § 172.480 Silicon dioxide. natural adjuvants may be safely used The food additive silicon dioxide may in food in accordance with the fol- be safely used in food in accordance lowing conditions. with the following conditions: (a) They are used in the minimum (a) The food additive is manufactured quantity required to produce their in- by vapor phase hydrolysis or by other tended physical or technical effect and means whereby the particle size is such in accordance with all the principles of as to accomplish the intended effect. good manufacturing practice. (b) It is used as an anticaking agent, (b) In the appropriate forms (plant subject to the following conditions: parts, fluid and solid extracts, con- (1) It is used in only those foods in cretes, absolutes, oils, gums, balsams, which the additive has been dem- resins, oleoresins, waxes, and dis- onstrated to have an anticaking effect. tillates) they consist of one or more of (2) It is used in an amount not in ex- the following, used alone or in com- cess of that reasonably required to bination with flavoring substances and produce its intended effect. adjuvants generally recognized as safe (3) [Reserved] in food, previously sanctioned for such (4) It is used in an amount not to ex- use, or regulated in any section of this ceed 2 percent by weight of the food. part.

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Common name Scientific name Limitations

Aloe ...... Aloe perryi Baker, A. barbadensis Mill., A. ferox Mill., and hybrids of this sp. with A. africana Mill. and A. spicata Baker. Althea root and flowers ...... Althea officinalis L. Amyris (West Indian sandalwood) ...... Amyris balsamifera L. Angola weed ...... Roccella fuciformis Ach ...... In alcoholic beverages only Arnica flowers ...... Arnica montana L., A. fulgens Pursh, A. sororia Do. Greene, or A. cordifolia Hooker. Artemisia (wormwood) ...... Artemisia spp ...... Finished food thujone free1 Artichoke leaves ...... Cynara scolymus L ...... In alcoholic beverages only Benzoin resin ...... Styrax benzoin Dryander, S. paralleloneurus Per- kins, S. tonkinensis (Pierre) Craib ex Hartwich, or other spp. of the Section Anthostyrax of the genus Styrax. Blackberry bark ...... Rubus, Section Eubatus. Boldus (boldo) leaves ...... Peumus boldus Mol ...... Do. Boronia flowers ...... Boronia megastigma Nees. Bryonia root ...... Bryonia alba L., or B. diocia Jacq ...... Do. Buchu leaves ...... Barosma betulina Bartl. et Wendl., B. crenulata (L.) Hook. or B. serratifolia Willd. Buckbean leaves ...... Menyanthes trifoliata L ...... Do. Cajeput ...... Melaleuca leucadendron L. and other Melaleuca spp. Calumba root ...... Jateorhiza palmata (Lam.) Miers ...... Do. Camphor tree ...... Cinnamomum camphora (L.) Nees et Eberm ...... Safrole free Cascara sagrada ...... Rhamnus purshiana DC. Cassie flowers ...... Acacia farnesiana (L.) Willd. Castor oil ...... Ricinus communis L. Catechu, black ...... Acacia catechu Willd. Cedar, white (aborvitae), leaves and twigs ... Thuja occidentalis L ...... Finished food thujone free1 Centuary ...... Centaurium umbellatum Gilib ...... In alcoholic beverages only Cherry pits ...... Prunus avium L. or P. cerasus L ...... Not to exceed 25 p.p.m. prussic acid Cherry-laurel leaves ...... Prunus laurocerasus L ...... Do. Chestnut leaves ...... Castanea dentata (Marsh.) Borkh. Chirata ...... Swertia chirata Buch.-Ham ...... In alcoholic beverages only Cinchona, red, bark ...... Cinchona succirubra Pav. or its hybrids ...... In beverages only; not more than 83 p.p.m. total cinchona alkaloids in finished beverage Cinchona, yellow, bark ...... Cinchona ledgeriana Moens, C. calisaya Wedd., or Do. hybrids of these with other spp. of Cinchona.. Copaiba ...... South American spp. of Copaifera L. Cork, oak ...... Quercus suber L., or Q. occidentalis F. Gay ...... In alcoholic beverages only Costmary ...... Chrysanthemum balsamita L ...... Do. Costus root ...... Saussurea lappa Clarke. Cubeb ...... Piper cubeba L. f. Currant, black, buds and leaves ...... Ribes nigrum L. Damiana leaves ...... Turnera diffusa Willd. Davana ...... Artemisia pallens Wall. Dill, Indian ...... Anethum sowa Roxb. (Peucedanum graveolens Benth et Hook., Anethum graveolens L.). Dittany (fraxinella) roots ...... Dictamnus albus L ...... Do. Dittany of Crete ...... Origanum dictamnus L. Dragon’s blood (dracorubin) ...... Daemonorops spp. Elder tree leaves ...... Sambucus nigra L ...... In alcoholic beverages only; not to exceed 25 p.p.m. prussic acid in the flavor Elecampane rhizome and roots ...... Inula helenium L ...... In alcoholic beverages only Elemi ...... Canarium commune L. or C. luzonicum Miq. Erigeron ...... Erigeron canadensis L. Eucalyptus globulus leaves ...... Eucalyptus globulus Labill. Fir (‘‘pine’’) needles and twigs ...... Abies sibirica Ledeb., A. alba Mill., A. sachalinesis Masters or A. mayriana Miyabe et Kudo. Fir, balsam, needles and twigs ...... Abies balsamea (L.) Mill. Galanga, greater ...... Alpinia galanga Willd ...... Do.

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Common name Scientific name Limitations

Galbanum ...... Ferula galbaniflua Boiss. et Buhse and other Ferula spp. Gambir (catechu, pale) ...... Uncaria gambir Roxb. Genet flowers ...... Spartium junceum L. Gentian rhizome and roots ...... Gentiana lutea L. Gentian, stemless ...... Gentiana acaulis L ...... Do. Germander, chamaedrys ...... Teucrium chamaedrys L ...... Do. Germander, golden ...... Teucrium polium L ...... Do. Guaiac ...... Guaiacum officinale L., G. santum L., Bulnesia sarmienti Lor. Guarana ...... Paullinia cupana HBK. Haw, black, bark ...... Viburnum prunifolium L. Hemlock needles and twigs ...... Tsuga canadensis (L.) Carr. or T. heterophylla (Raf.) Sarg. Hyacinth flowers ...... Hyacinthus orientalis L. Iceland moss ...... Cetraria islandica Ach ...... Do. Imperatoria ...... Peucedanum ostruthium (L.). Koch (Imperatoria ostruthium L.). Iva ...... Achillea moschata Jacq ...... Do. Labdanum ...... Cistus spp. Lemon-verbena ...... Lippia citriodora HBK ...... Do. Linaloe wood ...... Bursera delpechiana Poiss. and other Bursera spp. Linden leaves ...... Tillia spp ...... Do. Lovage ...... Levisticum officinale Koch. Lungmoss (lungwort) ...... Sticta pulmonacea Ach. Maidenhair fern ...... Adiantum capillus-veneris L ...... Do. Maple, mountain ...... Acer spicatum Lam. Mimosa (black wattle) flowers ...... Acacia decurrens Willd. var. dealbata. Mullein flowers ...... Verbascum phlomoides L. or V. thapsiforme Schrad Do. Myrrh ...... Commiphora molmol Engl., C. abyssinica (Berg) Engl., or other Commiphora spp. Myrtle leaves ...... Myrtus communis L ...... Do. Oak, English, wood ...... Quercus robur L ...... Do. Oak, white, chips ...... Quercus alba L. Oak moss ...... Evernia prunastri (L.) Ach., E. furfuracea (L.) Mann, Finished food thujone and other lichens. Olibanum ...... Boswellia carteri Birdw. and other Boswellia spp. Opopanax (bisabolmyrrh) ...... Opopanax chironium Koch (true opopanax) of Commiphora erythraea Engl. var. Llabrescens. Orris root ...... Iris germanica L. (including its variety florentina Dykes) and I. pallida Lam. Pansy ...... Viola tricolor L ...... In alcoholic beverages only Passion flower ...... Passiflora incarnata L. Patchouly ...... Pogostemon cablin Benth. and P. heyneanus Benth. Peach leaves ...... Prunus persica (L.) Batsch ...... In alcoholic beverages only; not to exceed 25 p.p.m. prussic acid in the flavor Pennyroyal, American ...... Hedeoma pulegioides (L.) Pers. Pennyroyal, European ...... Mentha pulegium L. Pine, dwarf, needles and twigs ...... Pinus mugo Turra var. pumilio (Haenke) Zenari. Pine, Scotch, needles and twigs ...... Pinus sylvestris L. Pine, white, bark ...... Pinus strobus L ...... In alcoholic beverages only Pine, white oil ...... Pinus palustris Mill., and other Pinus spp. Poplar buds ...... Populus balsamifera L. (P. tacamahacca Mill.), P. Do. candicans Ait., or P. nigra L. Quassia ...... Picrasma excelsa (Sw.) Planch, or Quassia amara L. Quebracho bark ...... Aspidosperma quebracho-blanco Schlecht, or Schinopsis lorentzii (Quebrachia lorentzii (Griseb)). (Griseb.) Engl. Quillaia (soapbark) ...... Quillaja saponaria Mol. Red saunders (red sandalwood) ...... Pterocarpus san alinus L ...... In alcoholic beverages only Rhatany root ...... Krameria triandra Ruiz et Pav. or K. argentea Mart. Rhubarb, garden root ...... Rheum rhaponticum L ...... Do. Rhubarb root ...... Rheum officinale Baill., R. palmatum L., or other spp. (excepting R. rhaponticum L.) or hybrids of Rheum grown in China. Roselle ...... Hibiscus sabdariffa L ...... Do. Rosin (colophony) ...... Pinus palustris Mill., and other Pinus spp ...... Do. St. Johnswort leaves, flowers, and caulis ...... Hypericum perforatum L ...... Hypericin-free alcohol distillate form only; in alcoholic beverages only

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Common name Scientific name Limitations

Sandalwood, white (yellow, or East Indian) ... Santalum album L. Sandarac ...... Tetraclinis articulata (Vahl.), Mast ...... In alcoholic beverages only Sarsaparilla ...... Smilax aristolochiaefolia Mill., (Mexican sarsaparilla), S. regelii Killip et Morton (Honduras sarsaparilla), S. febrifuga Kunth (Ecuadorean sarsaparilla), or undetermined Smilax spp. (Ecuadorean or Central American sarsaparilla). Sassafras leaves ...... Sassafras albidum (Nutt.) Nees ...... Safrole free Senna, Alexandria ...... Cassia acutifolia Delile. Serpentaria (Virginia snakeroot) ...... Aristolochia serpentaria L ...... In alcoholic beverages only Simaruba bark ...... Simaruba amara Aubl ...... Do. Snakeroot, Canadian (wild ginger) ...... Asarum canadense L. Spruce needles and twigs ...... Picea glauca (Moench) Voss or P. mariana (Mill.) BSP. Storax (styrax) ...... Liquidambar orientalis Mill. or L. styraciflua L. Tagetes (marigold) ...... Tagetes patula L., T. erecta L., or T. minuta L. (T. As oil only glandulifera Schrank). Tansy ...... Tanacetum vulgare L ...... In alcoholic beverages only; finished alcoholic beverage thujone free1 Thistle, blessed (holy thistle) ...... Onicus benedictus L ...... In alcoholic beverages only Thymus capitatus (Spanish ‘‘origanum’’) ...... Thymus capitatus Hoffmg. et Link. Tolu ...... Myroxylon balsamum (L.) Harms. Turpentine ...... Pinus palustris Mill. and other Pinus spp. which yield terpene oils exclusively. Valerian rhizome and roots ...... Valeriana officinalis L. Veronica ...... Veronica officinalis L ...... Do. Vervain, European ...... Verbena officinalis L ...... Do. Vetiver ...... Vetiveria zizanioides Stapf ...... Do. Violet, Swiss ...... Viola calcarata L. Walnut husks (hulls), leaves, and green nuts Juglans nigra L. or J. regia L. Woodruff, sweet ...... Asperula odorata L ...... In alcoholic beverages only Yarrow ...... Achillea millefolium L ...... In beverages only; finished beverage thujone free1 Yerba santa ...... Eriodictyon californicum (Hook, et Arn.) Torr. Yucca, Joshua-tree ...... Yucca brevifolia Engelm. Yucca, Mohave ...... Yucca schidigera Roezl ex Ortgies (Y. mohavensis Sarg.). 1 As determined by using the method (or, in other than alcoholic beverages, a suitable adaptation thereof) in section 9.129 of the ‘‘Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederic Ave., suite 500, Gaithersburg, MD 20877–2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408

[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 14644, Apr. 7, 1978; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989]

§ 172.515 Synthetic flavoring sub- food, prior-sanctioned for such use, or stances and adjuvants. regulated by an appropriate section in Synthetic flavoring substances and this part. adjuvants may be safely used in food in Acetal; acetaldehyde diethyl acetal. accordance with the following condi- Acetaldehyde phenethyl propyl acetal. tions. Acetanisole; 4′-methoxyacetophenone. (a) They are used in the minimum Acetophenone; methyl phenyl ketone. quantity required to produce their in- Allyl anthranilate. tended effect, and otherwise in accord- Allyl butyrate. ance with all the principles of good Allyl cinnamate. Allyl cyclohexaneacetate. manufacturing practice. Allyl cyclohexanebutyrate. (b) They consist of one or more of the Allyl cyclohexanehexanoate. following, used alone or in combination Allyl cyclohexaneproprionate. with flavoring substances and adju- Allyl cyclohexanevalerate. vants generally recognized as safe in Allyl disulfide.

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Allyl 2-ethylbutyrate. Benzyl propionate. Allyl hexanoate; allyl caproate. Benzyl salicylate. Allyl a-ionone; 1-(2,6,6-trimethyl-2-cyclo-hex- Birch tar oil. ene-1-yl)-1,6-heptadiene-3-one. Borneol; d-camphanol. Allyl isothiocyanate; mustard oil. Bornyl acetate. Allyl isovalerate. Bornyl formate. Allyl mercaptan; 2-propene-1-thiol. Bornyl isovalerate. Allyl nonanoate. Bornyl valerate. Allyl octanoate. b-Bourbonene; 1,2,3,3a,3bb,4,5,6,6ab,6ba-deca- Allyl phenoxyacetate. hydro-la-isopropyl-3aa-methyl-6-meth- Allyl phenylacetate. ylene-cyclobuta [1,2:3,4] dicyclopentene. Allyl propionate. 2-Butanol. Allyl sorbate; allyl 2,4-hexadienoate. 2-Butanone; methyl ethyl ketone. Allyl sulfide. Butter acids. Allyl tiglate; allyl trans-2-methyl-2- Butter esters. butenoate. Butyl acetate. Allyl 10-undecenoate. Butyl acetoacetate. Ammonium isovalerate. Butyl alcohol; 1-butanol. Ammonium sulfide. Butyl anthranilate. Amyl alcohol; pentyl alcohol. Butyl butyrate. Amyl butyrate. Butyl butyryllactate; lactic acid, butyl a-Amylcinnamaldehyde. ester, butyrate. a-Amylcinnamaldehyde dimethyl acetal. a-Butylcinnamaldehyde. a-Amylcinnamyl acetate. Butyl cinnamate. a-Amylcinnamyl alcohol. Butyl 2-decenoate. a-Amylcinnamyl formate. Butyl ethyl malonate. a-Amylcinnamyl isovalerate. Butyl formate. Amyl formate. Butyl heptanoate. Amyl heptanoate. Butyl hexanoate. Amyl hexanoate. Butyl p-hydroxybenzoate. Amyl octanoate. Butyl isobutyrate. Anisole; methoxybenzene. Butyl isovalerate. Anisyl acetate. Butyl lactate. Anisyl alcohol; p-methoxybenzyl alcohol. Butyl laurate. Anisyl butyrate Butyl levulinate. Anisyl formate. Butyl phenylacetate. Anisyl phenylacetate. Butyl propionate. Anisyl propionate. Butyl stearate. Beechwood creosote. Butyl sulfide. Benzaldehyde dimethyl acetal. Butyl 10-undecenoate. Benzaldehyde glyceryl acetal; 2-phenyl-m-di- Butyl valerate. oxan-5-ol. Butyraldehyde. Benzaldehyde propylene glycol acetal; 4- Cadinene. methyl-2-phenyl-m-dioxolane. Camphene; 2,2-dimethyl-3-methylene- Benzenethiol; thiophenol. norbornane. Benzoin; 2-hydroxy-2-phenylacetophenone. d-Camphor. Benzophenone; diphenylketone. Carvacrol; 2-p-cymenol. Benzyl acetate. Carvacryl ethyl ether; 2-ethoxy-p-cymene. Benzyl acetoacetate. Carveol; p-mentha-6,8-dien-2-ol. Benzyl alcohol. 4-Carvomenthenol; 1-p-menthen-4-ol; 4- Benzyl benzoate. terpinenol. Benzyl butyl ether. cis Carvone oxide; 1,6-epoxy-p-menth-8-en-2- Benzyl butyrate. one. Benzyl cinnamate. Carvyl acetate. Benzyl 2,3–dimethylcrotonate; benzyl methyl Carvyl propionate. tiglate. b-Caryophyllene. Benzyl disulfide; dibenzyl disulfide. Caryophyllene alcohol. Benzyl ethyl ether. Caryophyllene alcohol acetate. Benzyl formate. b-Caryophyllene oxide; 4-12,12-trimethyl-9- 3-Benzyl-4-heptanone; benzyl dipropyl ke- methylene-5-oxatricylo [8.2.0.04, 6] dode- tone. cane. Benzyl isobutyrate. Cedarwood oil alcohols. Benzyl isovalerate. Cedarwood oil terpenes. Benzyl mercaptan; a-toluenethiol. 1,4-Cineole. Benzyl methoxyethyl acetal; acetaldehyde Cinnamaldehyde ethylene glycol acetal. benzyl b-methoxyethyl acetal. Cinnamic acid. Benzyl phenylacetate. Cinnamyl acetate.

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Cinnamyl alcohol; 3-phenyl-2-propen-1-ol. a,a-Dimethylbenzyl isobutyrate; phenyldi- Cinnamyl benzoate. methylcarbinyl isobutyrate. Cinnamyl butyrate. 2,6-Dimethyl-5-heptenal. Cinnamyl cinnamate. 2,6-Dimethyl octanal; isodecylaldehyde. Cinnamyl formate. 3,7-Dimethyl-1-octanol; tetrahydrogeraniol. Cinnamyl isobutyrate. a,a-Dimethylphenethyl acetate; benzyl- Cinnamyl isovalerate. propyl acetate; benzyldimethylcarbinyl ac- Cinnamyl phenylacetate. etate. Cinnamyl propionate. a,a-Dimethylphenethyl alcohol; dimethyl- Citral diethyl acetal; 3,7-dimethyl-2,6-octa- benzyl carbinol. dienal diethyl acetal. a,a-Dimethylphenethyl butyrate; benzyl- Citral dimethyl acetal; 3,7-dimethyl-2,6-octa- dimethylcarbinyl butyrate. dienal dimethyl acetal. a,a-Dimethylphenethyl formate; benzyldi- Citral propylene glycol acetal. methylcarbinyl formate. Citronellal; 3,7-dimethyl-6-octenal; rhodinal. Dimethyl succinate. Citronellol; 3,7-dimethyl-6-octen-1-ol; d-cit- 1,3-Diphenyl-2-propanone; dibenzyl ketone. ronellol. delta-Dodecalactone; 5-hydroxydodecanoic Citronelloxyacetaldehyde. acid, deltalactone. Citronellyl acetate. g-Dodecalactone; 4-hydroxydodecanoic acid g- Citronellyl butyrate. lactone. Citronellyl formate. 2-Dodecenal. Citronellyl isobutyrate. Estragole. Citronellyl phenylacetate. r-Ethoxybenzaldehyde. Citronellyl propionate. Ethyl acetoacetate. Citronellyl valerate. Ethyl 2-acetyl-3-phenylpropionate; ethyl- p-Cresol. benzyl acetoacetate. Cuminaldehyde; cuminal; p-isopropyl benz- Ethyl aconitate, mixed esters. aldehyde. Ethyl acrylate. Cyclohexaneacetic acid. Ethyl r-anisate. Cyclohexaneethyl acetate. Ethyl anthranilate. Cyclohexyl acetate. Ethyl benzoate. Cyclohexyl anthranilate. Ethyl benzoylacetate. Cyclohexyl butyrate. a-Ethylbenzyl butyrate; a-phenylpropyl bu- Cyclohexyl cinnamate. tyrate. Cyclohexyl formate. Ethyl brassylate; tridecanedioic acid cyclic Cyclohexyl isovalerate. ethylene glycol diester; cyclo 1,13-ethyl- Cyclohexyl propionate. enedioxytridecan-1,13-dione. p-Cymene. 2-Ethylbutyl acetate. g-Decalactone; 4-hydroxy-decanoic acid, g- 2-Ethylbutyraldehyde. lactone. 2-Ethylbutyric acid. g-Decalactone; 5-hydroxy-decanoic acid, d- Ethyl cinnamate. lactone. Ethyl crotonate; trans-2-butenoic acid ethyl- Decanal dimethyl acetal. ester. 1-Decanol; decylic alcohol. Ethyl cyclohexanepropionate. 2-Decenal. Ethyl decanoate. 3-Decen-2-one; heptylidene acetone. 2-Ethylfuran. Decyl actate. Ethyl 2-furanpropionate. Decyl butyrate. 4-Ethylguaiacol; 4-ethyl-2-methoxyphenol. Decyl propionate. Ethyl heptanoate. Dibenzyl ether. 2-Ethyl-2-heptenal; 2-ethyl-3-butylacrolein. 4,4-Dibutyl-g-butyrolactone; 4,4-dibutyl-4-hy- Ethyl hexanoate. droxy-butyric acid, g-lactone. Ethyl isobutyrate. Dibutyl sebacate. Ethyl isovalerate. Diethyl malate. Ethyl lactate. Diethyl malonate; ethyl malonate. Ethyl laurate. Diethyl sebacate. Ethyl levulinate. Diethyl succinate. Ethyl maltol; 2-ethyl-3-hydroxy-4H-pyran-4- Diethyl tartrate. one. 2,5-Diethyltetrahydrofuran. Ethyl 2-methylbutyrate. Dihydrocarveol; 8-p-menthen-2-ol; 6-methyl- Ethyl myristate. 3-isopropenylcyclohexanol. Ethyl nitrite. Dihydrocarvone. Ethyl nonanoate. Dihydrocarvyl acetate. Ethyl 2-nonynoate; ethyl octyne carbonate. m-Dimethoxybenzene. Ethyl octanoate. p-Dimethoxybenzene; dimethyl hydro- Ethyl oleate. quinone. Ethyl phenylacetate. 2,4-Dimethylacetophenone. Ethyl 4-phenylbutyrate.

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Ethyl 3-phenylglycidate. w-6-Hexadecenlactone; 16-hydroxy-6- Ethyl 3-phenylpropionate; ethyl hydro- hexadecenoic acid, w-lactone; cinnamate. ambrettolide. Ethyl propionate. g-Hexalactone; 4-hydroxyhexanoic acid, g-lac- Ethyl pyruvate. tone; tonkalide. Ethyl salicylate. Hexanal; caproic aldehyde. Ethyl sorbate; ethyl 2,4-hexadienoate. 2,3-Hexanedione; acetyl butyryl. Ethyl tiglate; ethyl trans-2-methyl-2- Hexanoic acid; caproic acid. butenoate. 2-Hexenal. Ethyl undecanoate. 2-Hexen-1-ol. Ethyl 10-undecenoate. 3-Hexen-1-ol; leaf alcohol. Ethyl valerate. 2-Hexen-1-yl acetate. Eucalyptol; 1,8-epoxy-p-menthane; cineole. 3-Hexenyl isovalerate. Eugenyl acetate. 3-Hexenyl 2-methylbutyrate. Eugenyl benzoate. 3-Hexenyl phenylacetate; cis-3-hexenyl phen- Eugenyl formate. ylacetate. Eugenyl methyl ether; 4-allylveratrole; Hexyl acetate. methyl eugenol. 2-Hexyl-4-acetoxytetrahydrofuran. Farnesol; 3,7,11-trimethyl-2,6,10-dodecatrien- Hexyl alcohol. 1-ol. Hexyl butyrate. d-Fenchone; d-1,3,3-trimethyl-2-nor- a-Hexylcinnamaldehyde. bornanone. Hexyl formate. Fenchyl alcohol; 1,3,3-trimethyl-2-nor- Hexyl hexanoate. bornanol. 2-Hexylidene cyclopentanone. Formic acid Hexyl isovalerate. (2-Furyl)-2-propanone; furyl acetone. Hexyl 2-methylbutyrate. 1-Furyl-2-propanone; furyl acetone. Hexyl octanoate. Fusel oil, refined (mixed amyl alcohols). Hexyl phenylacetate; n-hexyl phenylacetate. Geranyl acetoacetate; trans-3,7-dimethyl-2, 6- Hexyl propionate. octadien-1-yl acetoacetate. Hydroxycitronellal; 3,7-dimethyl-7-hydroxy- Geranyl acetone; 6,10-dimethyl-5,9- octanal. undecadien-2-one. Hydroxycitronellal diethyl acetal. Geranyl benzoate. Hydroxycitronellal dimethyl acetal. Geranyl butyrate. Hydroxycitronellal; 3,7-dimethyl-1,7- Geranyl formate. octanediol. Geranyl hexanoate N-(4-Hydroxy-3-methoxybenzyl)-nonanamide; Geranyl isobutyrate. pelargonyl vanillylamide. Geranyl isovalerate. 5-Hydroxy-4-octanone; butyroin. Geranyl phenylacetate. 4-(p-Hydroxyphenyl)-2-butanone; p-hydroxy- Geranyl propionate. benzyl acetone. Glucose pentaacetate. Indole. Guaiacol; µ-methoxyphenol. a-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1- Guaiacyl acetate; µ-methoxyphenyl acetate. yl)-3-buten-2-one. Guaiacyl phenylacetate. b-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1- Guaiene; 1,4-dimethyl-7-isopropenyl-D9,10- yl)-3-buten-2-one. octahydroazulene. a-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene- Guaiol acetate; 1,4-dimethyl-7-(a-hydroxy- 1-yl)-3-buten-2-one; 6-methylionone. isopropyl)-d9,10-octahydroazulene acetate. Isoamyl acetate. g-Heptalactone; 4-hydroxyheptanoic acid, g- Isoamyl acetoacetate. lactone. Isoamyl alcohol; isopentyl alcohol; 3-methyl- Heptanal; enanthaldehyde. 1-butanol. Heptanal dimethyl acetal. Isoamyl benzoate. Heptanal 1,2-glyceryl acetal. Isoamyl butyrate. 2,3-Heptanedione; acetyl valeryl. Isoamyl cinnamate. 3-Heptanol. Isoamyl formate. 2-Heptanone; methyl amyl ketone. Isoamyl 2-furanbutyrate; a-isoamyl furfuryl- 3-Heptanone; ethyl butyl ketone. propionate. 4-Heptanone; dipropyl ketone. Isoamyl 2-furanpropionate; a-isoamyl fur- cis-4-Heptenal; cis-4-hepten-1-al. furylacetate. Heptyl acetate. Isoamyl hexanoate. Heptyl alcohol; enanthic alcohol. Isoamyl isobutyrate. Heptyl butyrate. Isoamyl isovalerate. Heptyl cinnamate. Isoamyl laurate. Heptyl formate. Isoamyl-2-methylbutyrate; isopentyl-2- Heptyl isobutyrate. methylbutyrate. Heptyl octanoate. Isoamyl nonanoate. 1-Hexadecanol; cetyl alcohol. Isoamyl octanoate.

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Isoamyl phenylacetate. Isoquinoline. Isoamyl propionate. Isovaleric acid. Isoamyl pyruvate. cis-Jasmone; 3-methyl-2-(2-pentenyl)-2-cyclo- Isoamyl salicylate. penten-1-one. Isoborneol. Lauric aldehyde; dodecanal. Isobornyl acetate. Lauryl acetate. Isobornyl formate. Lauryl alcohol; 1-dodecanol. Isobornyl isovalerate. Lepidine; 4-methylquinoline. Isobornyl propionate. Levulinic acid. Isobutyl acetate. Linalool oxide; cis- and trans-2-vinyl-2-meth- Isobutyl acetoacetate. yl-5-(1′-hydroxy-1′-methylethyl) tetra- Isobutyl alcohol. hydrofuran. Isobutyl angelate; isobutyl cis-2-methyl-2- Linalyl anthranilate; 3,7-dimethyl-1,6- butenoate. octadien-3-yl anthranilate. Isobutyl anthranilate. Linalyl benzoate. Isobutyl benzoate. Linalyl butyrate. Isobutyl butyrate. Linalyl cinnamate. Isobutyl cinnamate. Linalyl formate. Isobutyl formate. Linalyl hexanoate. Isobutyl 2-furanpropionate. Linalyl isobutyrate. Isobutyl heptanoate. Linalyl isovalerate. Isobutyl hexanoate. Linalyl octanoate. Isobutyl isobutyrate. Linalyl propionate. a-Isobutylphenethyl alcohol; isobutyl benzyl Maltol; 3-hydroxy-2-methyl-4H-pyran-4-one. carbinol; 4-methyl-1-phenyl-2-pentanol. Menthadienol; p-mentha-1,8(10)-dien-9-ol. Isobutyl phenylacetate. p-Mentha-1,8-dien-7-ol; perillyl alcohol. Isobutyl propionate. Menthadienyl acetate; p-mentha-1,8(10)-dien- Isobutyl salicylate. 9-yl acetate. 2-Isobutylthiazole. p-Menth-3-en-1-ol. Isobutyraldehyde. 1-p-Menthen-–9-yl acetate; p-menth-1-en-9-yl Isobutyric acid. acetate. Isoeugenol; 2-methoxy-4-propenylphenol. Menthol; 2-isopropyl-5-methylcyclohexanol. Isoeugenyl acetate. Menthone; p-menthan-3-one. Isoeugenyl benzyl ether; benzyl isoeugenol. Menthyl acetate; p-menth-3-yl acetate. Isoeugenyl ethyl ether; 2-ethoxy-5-propenyl- Menthyl isovalerate; p-menth-3-yl iso- anisole; ethyl isoeugenol. valerate. Isoeugenyl formate. o-Methoxybenzaldehyde. Isoeugenyl methyl ether; 4-propenyl- p-Methoxybenzaldehyde; p-anisaldehyde. veratrole; methyl isoeugenol. o-Methoxycinnamaldehyde. Isoeugenyl phenylacetate. 2-Methoxy-4-methylphenol; 4-methyl- Isojasmone; mixture of 2-hexylidenecyclo- guaiacol; 2-methoxy-p-cresol. pentanone and 2-hexyl-2-cyclopenten-1-one. 4-(p-Methoxyphenyl)-2-butanone; anisyl ace- a-Isomethylionone; 4-(2,6,6-trimethyl-2- tone. cyclohexen-1-yl)-3-methyl-3-buten-2-one; 1-(4-Methoxyphenyl)-4-methyl-1-penten-3- methyl g-ionone. one; methoxystyryl isopropyl ketone. Isopropyl acetate. 1-(p-Methoxyphenyl)-1-penten-3-one; a- r-Isopropylacetophenone. methylanisylidene acetone; ethone. Isopropyl alcohol; isopropanol. 1-(p-Methoxyphenyl)-2-propanone; Isopropyl benzoate. anisylmethyl ketone; anisic ketone. r-Isopropylbenzyl alcohol; cuminic alcohol; 2-Methoxy-4-vinylphenol; p-vinylguaiacol. r-cymen-7-ol. Methyl acetate. Isopropyl butyrate. 4′-Methylacetophenone; p-methylaceto- Isopropyl cinnamate. phenone; methyl p-tolyl ketone. Isopropyl formate. 2-Methylallyl butyrate; 2-methyl-2-propenl- Isopropyl hexanoate. yl butyrate. Isopropyl isobutyrate. Methyl anisate. Isopropyl isovalerate. o-Methylanisole; o-cresyl methyl ether. r-Isopropylphenylacetaldehyde; r-cymen-7- p-Methylanisole; p-cresyl methyl ether; p- carboxaldehyde. methoxytoluene. Isopropyl phenylacetate. Methyl benzoate. 3-(r-Isopropylphenyl)-propionaldehyde; r-iso- Methylbenzyl acetate, mixed o-,m-,p-. propylhydrocinnamaldehyde; cuminyl ac- a-Methylbenzyl acetate; styralyl acetate. etaldehyde. a-Methylbenzyl alcohol; styralyl alcohol. Isopropyl propionate. a-Methylbenzyl butyrate; styralyl butyrate. Isopulegol; p-menth-8-en-3-ol. a-Methylbenzyl isobutyrate; styralyl iso- Isopulegone; p-menth-8-en-3-one. butyrate. Isopulegyl acetate. a-Methylbenzyl formate; styralyl formate. 60

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a-Methylbenzyl propionate; styralyl propio- 2-Methyl-4-phenyl-2-butyl acetate; dimethyl- nate. phenylethyl carbinyl acetate. 2-Methyl-3-buten-2-ol. 2-Methyl-4-phenyl-2-butyl isobutyrate; 2-Methylbutyl isovalerate. dimethylphenyl ethylcarbinyl isobutyrate. Methyl p-tert-butylphenylacetate. 3-Methyl-2-phenylbutyraldehyde; a-isopropyl 2-Methylbutyraldehyde; methyl ethyl acetal- phenylacetaldehyde. dehyde. Methyl 4-phenylbutyrate. 3-Methylbutyraldehyde; isovaleraldehyde. 4-Methyl-1-phenyl-2-pentanone; benzyl iso- Methyl butyrate. butyl ketone. 2-Methylbutyric acid. Methyl 3-phenylpropionate; methyl hydro- a-Methylcinnamaldehyde. cinnamate. p-Methylcinnamaldehyde. Methyl propionate. Methyl cinnamate. 3-Methyl-5-propyl-2-cyclohexen-1-one. 2-Methyl-1,3-cyclohexadiene. Methyl sulfide. Methylcyclopentenolone; 3-methylcyclopen- 3-Methylthiopropionaldehyde; methional. tane-1,2-dione. 2-Methyl-3-tolylpropionaldehyde, mixed o-, Methyl disulfide; dimethyl disulfide. m-, p-. Methyl ester of rosin, partially hydrogenated 2-Methylundecanal; methyl nonyl acetal- (as defined in § 172.615); methyl dehyde. dihydroabietate. Methyl 9-undecenoate. Methyl heptanoate. Methyl 2-undecynoate; methyl decyne car- 2-Methylheptanoic acid. bonate. 6-Methyl-3,5-heptadien-2-one. Methyl valerate. Methyl-5-hepten-2-ol. 2-Methylvaleric acid. 6-Methyl-5-hepten-2-one. Myrcene; 7-methyl-3-methylene-1,6-octa- diene. Methyl hexanoate. Myristaldehyde; tetradecanal. Methyl 2-hexanoate. d-Neomenthol; 2-isopropyl-5-methylcyclo- Methyl p-hydroxybenzoate; methylparaben. hexanol. Methyl -ionone; 5-(2,6,6-trimethyl-2-cyclo- a Nerol; cis-3,7-dimethyl-2,6-octadien-1-ol. hexen-1-yl)-4-penten-3-one. Nerolidol; 3,7,11-trimethyl-1,6,10-dodecatrien- Methyl -ionone; 5-(2,6,6-trimethyl-1-cyclo- b 3-ol. hexen-1-yl)-4-penten-3-one. Neryl acetate. Methyl D-ionone; 5-(2,6,6-trimethyl-3-cyclo- Neryl butyrate. hexen-1-yl-)-4-penten-3-one. Neryl formate. Methyl isobutyrate. Neryl isobutyrate. 2-Methyl-3-(p-isopropylphenyl)-propionalde- Neryl isovalerate. hyde; a-methyl-p-isopropylhydro- Neryl propionate. cinnamaldehyde; cyclamen aldehyde. 2,6-Nonadien-1-ol. Methyl isovalerate. g-Nonalactone; 4-hydroxynonanoic acid, g- Methyl laurate. lactone; aldehyde C–18. Methyl mercaptan; methanethiol. Nonanal; pelargonic aldehyde. Methyl o-methoxybenzoate. 1,3-Nonanediol acetate, mixed esters. Methyl N-methylanthranilate; dimethyl an- Nonanoic acid; pelargonic acid. thranilate. 2-Nonanone; methylheptyl ketone. Methyl 2-methylbutyrate. 3-Nonanon-1-yl acetate; 1-hydroxy-3- Methyl-3-methylthiopropionate. nonanone acetate. Methyl 4-methylvalerate. Nonyl acetate. Methyl myristate. Nonyl alcohol; 1-nonanol. Methyl b-naphthyl ketone; 2′-acetonaph- Nonyl octanoate. thone. Nonyl isovalerate. Methyl nonanoate. Nootkatone; 5,6-dimethyl-8-isopropenyl- Methyl 2-nonenoate. bicyclo[4,4,0]-dec-1-en-3-one. Methyl 2-nonynoate; methyloctyne car- Ocimene; trans-b-ocimene; 3,7-dimethyl-1,3,6- bonate. octatriene. 2-Methyloctanal; methyl hexyl acetaldehyde. g-Octalactone; 4-hydroxyoctanoic acid, g-lac- Methyl octanoate. tone. Methyl 2-octynoate; methyl heptine car- Octanal; caprylaldehyde. bonate. Octanal dimethyl acetal. 4-Methyl-2,3-pentanedione; acetyl iso- 1-Octanol; octyl alcohol. butyryl. 2-Octanol. 4-Methyl-2-pentanone; methyl isobutyl ke- 3-Octanol. tone. 2-Octanone; methyl hexyl ketone. b-Methylphenethyl alcohol; hydratropyl al- 3-Octanone; ethyl amyl ketone. cohol. 3-Octanon-1-ol. Methyl phenylacetate. 1-Octen-3-ol; amyl vinyl carbinol. 3-Methyl-4-phenyl-3-butene-2-one. 1-Octen-3-yl acetate.

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Octyl acetate. 3-Phenylpropyl formate. 3-Octyl acetate. 3-Phenylpropyl hexanoate. Octyl butyrate. 2-Phenylpropyl isobutyrate. Octyl formate. 3-Phenylpropyl isobutyrate. Octyl heptanoate. 3-Phenylpropyl isovalerate. Octyl isobutyrate. 3-Phenylpropyl propionate. Octyl isovalerate. 2-(3-Phenylpropyl)-tetrahydrofuran. Octyl octanoate. a-Pinene; 2-pinene. Octyl phenylacetate. b-Pinene; 2(10)-pinene. Octyl propionate. Pine tar oil. w-Pentadecalactone; 15-hydroxypentadeca- Pinocarveol; 2(10)-pinen-3-ol. noic acid, w-lactone; pentadecanolide; an- Piperidine. gelica lactone. Piperine. 2,3-Pentanedione; acetyl propionyl. d-Piperitone; p-menth-1-en-3-one. 2-Pentanone; methyl propyl ketone. Piperitenone; p-mentha-1,4(8)-dien-3-one. 4-Pentenoic acid. Piperitenone oxide; 1,2-epoxy-p-menth-4-(8)- 1-Penten-3-ol. en-3-one. Perillaldehyde; 4-isopropenyl-1-cyclohexene- Piperonyl acetate; heliotropyl acetate. 1-carboxaldehyde;p-mentha-1,8-dien-7-al. Piperonyl isobutyrate. Perillyl acetate; p-mentha-1,8-dien-7-yl ace- Polylimonene. tate. Polysorbate 20; polyoxyethylene (20) sorbitan a-Phellandrene; r-mentha-1,5-diene. monolaurate. Phenethyl acetate. Polysorbate 60; polyoxyethylene (20) sorbitan Phenethyl alcohol; b-phenylethyl alcohol. monostereate. Phenethyl anthranilate. Polysorbate 80; polyoxyethylene (20) sorbitan Phenethyl benzoate. monooleate. Phenethyl butyrate. Potassium acetate. Phenethyl cinnamate. Propenylguaethol; 6-ethoxy-m-anol. Phenethyl formate. Propionaldehyde. Phenethyl isobutyrate. Propyl acetate. Phenethyl isovalerate. Propyl alcohol; 1-propanol. Phenethyl 2-methylbutyrate. p-Propyl anisole; dihydroanethole. Phenethyl phenylacetate. Propyl benzoate. Phenethyl propionate. Propyl butyrate. Phenethyl salicylate. Propyl cinnamate. Phenethyl senecioate; phenethyl 3,3-di- Propyl disulfide. methylacrylate. Propyl formate. Phenethyl tiglate. Propyl 2-furanacrylate. Phenoxyacetic acid. Propyl heptanoate. 2-Phenoxyethyl isobutyrate. Propyl hexanoate. Phenylacetaldehyde; a-toluic aldehyde. Propyl p-hydroxybenzoate; propylparaben. Phenylacetaldehyde 2,3-butylene glycol ace- 3-Propylidenephthalide. tal. Propyl isobutyrate. Phenylacetaldehyde dimethyl acetal. Propyl isovalerate. Phenylacetaldehyde glyceryl acetal. Propyl mercaptan. Phenylacetic acid; a-toluic acid. a-Propylphenethyl alcohol. 4-Phenyl-2-butanol; phenylethyl methyl car- Propyl phenylacetate. binol. Propyl propionate. 4-Phenyl-3-buten-2-ol; methyl styryl car- Pulegone; p-menth-4(8)-en-3-one. binol. Pyridine. 4-Phenyl-3-buten-2-one. Pyroligneous acid extract. 4-Phenyl-2-butyl acetate; phenylethyl meth- Pyruvaldehyde. yl carbinyl acetate. Pyruvic acid. 1-Phenyl-3-methyl-3-pentanol; phenylethyl Rhodinol; 3,7-dimethyl-7-octen-1-ol; l- methyl ethyl carbinol. citronellol. 1-Phenyl-1-propanol; phenylethyl carbinol. Rhodinyl acetate. 3-Phenyl-1-propanol; hydrocinnamyl alcohol. Rhodinyl butyrate. 2-Phenylpropionaldehyde; hydratropalde- Rhodinyl formate. hyde. Rhodinyl isobutyrate. 3-Phenylpropionaldehyde; hydrocinnamal- Rhodinyl isovalerate. dehyde. Rhodinyl phenylacetate. 2-Phenylpropionalde-hyde dimethyl acetal; Rhodinyl propionate. hydratropic aldehyde dimethyl acetal. Rum ether; ethyl oxyhydrate. 3-Phenylpropionic acid; hydrocinnamic acid. Salicylaldehyde. 3-Phenylpropyl acetate. Santalol, a and b. 2-Phenylpropyl butyrate. Santalyl acetate. 3-Phenylpropyl cinnamate. Santalyl phenylacetate.

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Skatole. spectively, in accordance with § 166.110 Sorbitan monostearate. of this chapter. Styrene. (d) BHA (butylated hydroxyanisole) Sucrose octaacetate. a-Terpinene. may be used as an antioxidant in fla- g-Terpinene. voring substances whereby the additive a-Terpineol; p-menth-1-en-8-ol. does not exceed 0.5 percent of the es- b-Terpineol. sential (volatile) oil content of the fla- Terpinolene; p-menth-1,4(8)-diene. voring substance. Terpinyl acetate. Terpinyl anthranilate. [42 FR 14491, Mar. 15, 1977, as amended at 42 Terpinyl butyrate. FR 23148, May 6, 1977; 43 FR 19843, May 9, Terpinyl cinnamate. 1978; 45 FR 22915, Apr. 4, 1980; 47 FR 27810, Terpinyl formate. June 25, 1982; 48 FR 10812, Mar. 15, 1983; 48 FR Terpinyl isobutyrate. 51907, Nov. 15, 1983; 49 FR 5747, Feb. 15, 1984; Terpinyl isovalerate. 50 FR 42932, Oct. 23, 1985; 54 FR 7402, Feb. 21, Terpinyl propionate. 1989; 61 FR 14245, Apr. 1, 1996] Tetrahydrofurfuryl acetate. Tetrahydrofurfuryl alcohol. § 172.520 Cocoa with dioctyl sodium Tetrahydrofurfuryl butyrate. sulfosuccinate for manufacturing. Tetrahydrofurfuryl propionate. Tetrahydro-pseudo-ionone; 6,10-dimethyl-9- The food additive ‘‘cocoa with dioctyl undecen-2-one. sodium sulfosuccinate for manufac- Tetrahydrolinalool; 3,7-dimethyloctan-3-ol. turing,’’ conforming to § 163.117 of this Tetramethyl ethylcyclohexenone; mixture of chapter and § 172.810, is used or in- 5-ethyl-2,3,4,5-tetramethyl-2-cyclohexen-1- tended for use as a flavoring substance one and 5-ethyl-3,4,5,6-tetramethyl-2-cyclo- in dry beverage mixes whereby the hexen-1-one. 2-Thienyl mercaptan; 2-thienylthiol. amount of dioctyl sodium sulfo- Thymol. succinate does not exceed 75 parts per Tolualdehyde glyceryl acetal, mixed o, m, p. million of the finished beverage. The Tolualdehydes, mixed o, m, p. labeling of the dry beverage mix shall p-Tolylacetaldehyde. bear adequate directions to assure use o-Tolyl acetate; o-cresyl acetate. in compliance with this section. p-Tolyl acetate; p-cresyl acetate. 4-(p-Tolyl)-2-butanone; p-methylbenzylace- § 172.530 Disodium guanylate. tone. p-Tolyl isobutyrate. Disodium guanylate may be safely p-Tolyl laurate. used as a flavor enhancer in foods, at a p-Tolyl phenylacetate. level not in excess of that reasonably 2-(p-Tolyl)-propionaldehyde; p-methylhydra- required to produce the intended effect. tropic aldehyde. Tributyl acetylcitrate. 2-Tridecenal. § 172.535 Disodium inosinate. 2,3-Undecadione; acetyl nonyryl. The food additive disodium inosinate g-Undecalactone; 4-hydroxyundecanoic acid may be safely used in food in accord- g-lactone; peach aldehyde; aldehyde C–14. ance with the following prescribed con- Undecenal. 2-Undecanone; methyl nonyl ketone. ditions: 9-Undecenal; undecenoic aldehyde. (a) The food additive is the disodium 10-Undecenal. salt of inosinic acid, manufactured and Undecen-1-ol; undecylenic alcohol. purified so as to contain no more than 10-Undecen-1-yl acetate. 150 parts per million of soluble barium Undecyl alcohol. in the compound disodium inosinate Valeraldehyde; pentanal. with seven and one-half molecules of Valeric acid; pentanoic acid. Vanillin acetate; acetyl vanillin. water of crystallization. Veratraldehyde. (b) The food additive is used as a fla- Verbenol; 2-pinen-4-ol. voring adjuvant in food. Zingerone; 4-(4-hydroxy-3-methoxyphenyl)-2- butanone. § 172.540 DL–Alanine. (c) D-Decalactone and D- DL–Alanine (a racemic mixture of D- dodecalactone when used separately or and L-alanine; CAS Reg. No. 302–72–7) in combination in oleomargarine are may be safely used as a flavor enhancer used at levels not to exceed 10 parts per for sweeteners in pickling mixtures at million and 20 parts per million, re- a level not to exceed 1 percent of the

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pickling spice that is added to the and fractionations, using methylene pickling brine. chloride, hexane, and methyl alcohol as [56 FR 6968, Feb. 21, 1991] solvents, followed by isomerization by sodium hydroxide treatment. Residues § 172.560 Modified hop extract. of the solvents in the modified hop ex- The food additive modified hop extract shall not exceed 5 parts per mil- tract may be safely used in beer in ac- lion of methylene chloride, 25 parts per cordance with the following prescribed million of hexane, and 100 parts per conditions: million of methyl alcohol. (a) The food additive is used or in- (4) The additive is manufactured tended for use as a flavoring agent in from hops by a sequence of extractions the brewing of beer. and fractionations, using benzene, light (b) The food additive is manufactured petroleum spirits, methyl alcohol, n- by one of the following processes: butyl alcohol, and ethyl acetate as sol- (1) The additive is manufactured vents, followed by isomerization by po- from a hexane extract of hops by si- tassium carbonate treatment. Residues multaneous isomerization and selec- of solvents in the modified hop extract tive reduction in an alkaline aqueous shall not exceed 1.0 part per million of medium with sodium borohydride, benzene, 1.0 part per million of light whereby the additive meets the fol- petroleum spirits, 50 parts per million lowing specifications: of methyl alcohol, 50 parts per million (i) A solution of the food additive sol- of n-butyl alcohol, and 1 part per mil- ids is made up in approximately 0.012 n lion of ethyl acetate. The light petro- alkaline methyl alcohol (6 milliliters leum spirits and benzene solvents shall of 1 n sodium hydroxide diluted to 500 comply with the specifications in milliliters with methyl alcohol) to § 172.250 except that the boiling point show an absorbance at 253 millimicrons range for light petroleum spirits is 150 of 0.6 to 0.9 per centimeter. (This ab- °F to 300 °F. sorbance is obtained by approximately (5) The additive is manufactured 0.03 milligram solids permilliliter.) The from hops by an initial extraction and ultraviolet absorption spectrum of this fractionation using one or more of the solution exhibits the following charac- following solvents: Ethylene dichlo- teristics: An absorption peak at 253 ride, hexane, isopropyl alcohol, methyl millimicrons; no absorption peak at 325 alcohol, methylene chloride, trichloro- to 330 millimicrons; the absorbance at 268 millimicrons does not exceed the ethylene, and water; followed by absorbance at 272 millimicrons. isomerization by calcium chloride or (ii) The boron content of the food ad- magnesium chloride treatment in ditive does not exceed 310 parts per ethylene dichloride, methylene chlo- million (0.0310 percent), calculated as ride, or trichloroethylene and a further boron. sequence of extractions and fraction- (2) The additive is manufactured ations using one or more of the sol- from hops by a sequence of extractions vents set forth in this paragraph. Resi- and fractionations, using benzene, light dues of the solvents in the modified petroleum spirits, and methyl alcohol hop extract shall not exceed 125 parts as solvents, followed by isomerization per million of hexane; 150 parts per mil- by potassium carbonate treatment. lion of ethylene dichloride, methylene Residues of solvents in the modified chloride, or trichloroethylene; or 250 hop extract shall not exceed 1.0 part parts per million of isopropyl alcohol per million of benzene, 1.0 part per mil- or methyl alcohol. lion of light petroleum spirits, and 250 (6) The additive is manufactured parts per million of methyl alcohol. from hops by an initial extraction and The light petroleum spirits and ben- fractionation using one or more of the zene solvents shall comply with the solvents listed in paragraph (b)(5) of specifications in § 172.250 except that this section followed by: Hydro- the boiling point range for light petro- genation using palladium as a catalyst leum spirits is 150 °F–300 °F. in methyl alcohol, ethyl alcohol, or (3) The additive is manufactured isopropyl alcohol acidified with hydro- from hops by a sequence of extractions chloric or sulfuric acid; oxidation with

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peracetic acid; isomerization by cal- (a) The additive is the aqueous ex- cium chloride or magnesium chloride tract obtained from the root bark of treatment in ethylene dichloride, the plant Sassafras albidum (Nuttall) methylene chloride, or trichloro- Nees (Fam. Lauraceae). ethylene (alternatively, the hydro- (b) It is obtained by extracting the genation and isomerization steps may bark with dilute alcohol, first concen- be performed in reverse order); and a trating the alcoholic solution by vacu- further sequence of extractions and um distillation, then diluting the con- fractionations using one or more of the centrate with water and discarding the solvents listed in paragraph (b)(5) of oily fraction. this section. The additive shall meet (c) The purified aqueous extract is the residue limitations as prescribed in safrole-free. paragraph (b)(5) of this section. (d) It is used as a flavoring in food. (7) The additive is manufactured from hops as set forth in paragraph § 172.585 Sugar beet extract flavor (b)(6) of this section followed by reduc- base. tion with sodium borohydride in aque- Sugar beet extract flavor base may ous alkaline methyl alcohol, and a se- be safely used in food in accordance quence of extractions and fraction- with the provisions of this section. ations using one or more of the sol- (a) Sugar beet extract flavor base is vents listed in paragraph (b)(5) of this the concentrated residue of soluble section. The additive shall meet the sugar beet extractives from which residue limitations as prescribed in sugar and glutamic acid have been re- paragraph (b)(5) of this section, and a covered, and which has been subjected boron content level not in excess of 300 to ion exchange to minimize the con- parts per million (0.0300 percent), cal- centration of naturally occurring trace culated as boron. minerals. (8) The additive is manufactured (b) It is used as a flavor in food. from hops as a nonisomerizable nonvolatile hop resin by an initial extrac- § 172.590 Yeast-malt sprout extract. tion and fractionation using one or Yeast-malt sprout extract, as de- more of the solvents listed in para- scribed in this section, may be safely graph (b)(5) of this section followed by used in food in accordance with the fol- a sequence of aqueous extractions and lowing prescribed conditions: removal of nonaqueous solvents to less (a) The additive is produced by par- than 0.5 percent. The additive is added tial hydrolysis of yeast extract (de- to the wort before or during cooking in rived from Saccharomyces cereviseae, the manufacture of beer. Saccharomyces fragilis, or Candida utilis) using the sprout portion of malt barley § 172.575 Quinine. as the source of enzymes. The additive Quinine, as the hydrochloride salt or contains a maximum of 6 percent 5′ nu- sulfate salt, may be safely used in food cleotides by weight. in accordance with the following condi- (b) The additive may be used as a fla- tions: vor enhancer in food at a level not in excess of that reasonably required to Uses Limitations produce the intended effect. In carbonated bev- Not to exceed 83 parts per million, as erages as a flavor. quinine. Label shall bear a promi- Subpart G—Gums, Chewing Gum nent declaration of the presence of quinine either by the use of the Bases and Related Substances word ‘‘quinine’’ in the name of the article or through a separate dec- § 172.610 Arabinogalactan. laration. Arabinogalactan may be safely used in food in accordance with the fol- § 172.580 Safrole-free extract of sas- lowing conditions: safras. (a) Arabinogalactan is a poly- The food additive safrole-free extract saccharide extracted by water from of sassafras may be safely used in ac- Western larch wood, having galactose cordance with the following prescribed units and arabinose units in the ap- conditions: proximate ratio of six to one.

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(b) It is used in the following foods in of chewing gum in accordance with the the minimum quantity required to following prescribed conditions: produce its intended effect as an emul- (a) The food additive consists of one sifier, stabilizer, binder, or bodying or more of the following substances agent: Essential oils, nonnutritive that meet the specifications and limi- sweeteners, flavor bases, nonstandard- tations prescribed in this paragraph, ized dressings, and pudding mixes. used in amounts not to exceed those re- § 172.615 Chewing gum base. quired to produce the intended physical or other technical effect. The food additive chewing gum base may be safely used in the manufacture

MASTICATORY SUBSTANCES NATURAL (COAGULATED OR CONCENTRATED LATICES) OF VEGETABLE ORIGIN

Family Genus and species

Sapotaceae: Chicle ...... Manilkara zapotilla Gilly and Manilkara chicle Gilly. Chiquibul ...... Manilkara zapotilla Gilly. Crown gum ...... Manilkara zapotilla Gilly and Manilkara chicle Gilly. Gutta hang kang ...... Palaquium leiocarpum Boerl. and Palaquium oblongifolium Burck. Massaranduba balata (and the solvent-free Manilkara huberi (Ducke) Chevalier. resin extract of Massaranduba balata). Massaranduba chocolate ...... Manilkara solimoesensis Gilly. Nispero ...... Manilkara zapotilla Gilly and Manilkara chicle Gilly. Rosidinha (rosadinha) ...... Micropholis (also known as Sideroxylon) spp. Venezuelan chicle ...... Manilkara williamsii Standley and related spp. Apocynaceae: Jelutong ...... Dyera costulata Hook, F. and Dyera lowii Hook, F. Leche caspi (sorva) ...... Couma macrocarpa Barb. Rodr. Pendare ...... Couma macrocarpa Barb. Rodr. and Couma utilis (Mart.) Muell. Arg. Perillo ...... Couma macrocarpa Barb. Rodr. and Couma utilis (Mart.) Muell. Arg. Moraceae: Leche de vaca ...... Brosimum utile (H.B.K.) Pittier and Poulsenia spp.; also Lacmellea standleyi (Woodson), Monachino (Apocynaceae). Niger gutta ...... Ficus platyphylla Del. Tunu (tuno) ...... Castilla fallax Cook. Euphorbiaceae: Chilte ...... Cnidoscolus (also known as Jatropha) elasticus Lundell and Cnidoscolus tepiquensis (Cost. and Gall.) McVaugh. Natural rubber (smoked sheet and latex sol- Hevea brasiliensis. ids).

Synthetic Specifications

Butadiene-styrene rubber ...... Basic polymer. Isobutylene-isoprene copolymer (butyl rub- Do. ber). Paraffin ...... Synthesized by Fischer-Tropsch process from carbon monoxide and hydrogen which are catalytically converted to a mixture of paraffin hydrocarbon. Lower molecular weight fractions are removed by distillation. The residue is hydrogenated and further treated by percolation through activated charcoal. The product has a congealing point of 93°–99 °C as determined by ASTM method D938–71 (Reapproved 1981), ‘‘Standard Test Method for Con- gealing Point of Petroleum Waxes, Including Petrolatum,’’ a maximum oil content of 0.5 percent as determined by ASTM method D721–56T, ‘‘Ten- tative Method of Test for Oil Content of Petroleum Waxes,’’ and an absorptivity of less than 0.01 at 290 millimicrons in decahydronaphthalene at 88 °C as determined by ASTM method D2008–80, ‘‘Standard Test Method for Ultraviolet Absorbance and Absorptivity of Petroleum Products,’’ which are incorporated by reference. Copies may be obtained from the American So- ciety for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Petroleum wax ...... Complying with § 172.886. Petroleum wax synthetic ...... Complying with § 172.888. Polyethylene ...... Molecular weight 2,000–21,000. Polyisobutylene ...... Minimum molecular weight 37,000 (Flory). Polyvinyl acetate ...... Molecular weight, minimum 2,000.

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MASTICATORY SUBSTANCES—Continued NATURAL (COAGULATED OR CONCENTRATED LATICES) OF VEGETABLE ORIGIN

Family Genus and species

PLASTICIZING MATERIALS (SOFTENERS)

Glycerol ester of partially dimerized rosin ...... Having an acid number of 3–8, a minimum drop-softening point of 109 °C, and a color of M or paler. Glycerol ester of partially hydrogenated gum or Having an acid number of 3–10, a minimum drop-softening point of 79 °C, wood rosin. and a color of N or paler. Glycerol ester of polymerized rosin ...... Having an acid number of 3–12, a minimum melting-point of 80 °C, and a color of M or paler. Glycerol ester of gum rosin ...... Having an acid number of 5–9, a minimum drop-softening point of 88 °C, and a color of N or paler. The ester is purified by steam stripping. Glycerol ester of tall oil rosin ...... Having an acid number of 2–12, a softening point (ring and ball) of 80°–88 °C, and a color of N or paler. The ester is purified by steam stripping. Glycerol ester of wood rosin ...... Having an acid number of 3–9, a drop-softening point of 88 °C–96 °C, and a color of N or paler. The ester is purified by steam stripping. Lanolin ...... Methyl ester of rosin, partially hydrogenated ...... Having an acid number of 4–8, a refractive index of 1.5170–1.5205 at 20 °C, and a viscosity of 23–66 poises at 25 °C. The ester is purified by steam stripping. Pentaerythritol ester of partially hydrogenated Having an acid number of 7–18, a minimum drop-softening point of 102 °C, gum or wood rosin. and a color of K or paler. Pentaerythritol ester of gum or wood rosin ...... Having an acid number of 6–16, a minimum drop-softening point of 109 °C, and a color of M or paler. Rice bran wax ...... Complying with § 172.890. Stearic acid ...... Complying with § 172.860. Sodium and potassium stearates ...... Complying with § 172.863.

TERPENE RESINS

Synthetic resin ...... Consisting of polymers of apinene, bpinene, and/or dipentene; acid value less than 5, saponification number less than 5, and color less than 4 on the Gardner scale as measured in 50 percent mineral spirit solution. Natural resin ...... Consisting of polymers of a-pinene; softening point minimum 155 °C, determined by U.S.P. closed-capillary method, United States Pharmacopeia XX (1980) (page 961).

ANTIOXIDANTS

Butylated hydroxyanisole ...... Not to exceed antioxidant content of 0.1% when used alone or in any combination. Butylated hydroxytoluene ...... Do. Propyl gallate ...... Do.

MISCELLANEOUS

Sodium sulfate ...... Sodium sulfide ...... Reaction-control agent in synthetic polymer production.

(b) In addition to the substances list- ingredients named and so defined in ed in paragraph (a) of this section, paragraph (a) of this section. chewing gum base may also include [42 FR 14491, Mar. 15, 1977, as amended at 45 substances generally recognized as safe FR 56051, Aug. 22, 1980; 49 FR 5747, Feb. 15, in food. 1984; 49 FR 10105, Mar. 19, 1984; 66 FR 38153, (c) To assure safe use of the additive, July 23, 2001; 66 FR 53711, Oct. 24, 2001] in addition to the other information required by the act, the label and label- § 172.620 Carrageenan. ing of the food additive shall bear the The food additive carrageenan may name of the additive, ‘‘chewing gum be safely used in food in accordance base.’’ As used in this paragraph, the with the following prescribed condi- term ‘‘chewing gum base’’ means the tions: manufactured or partially manufac- (a) The food additive is the refined tured nonnutritive masticatory sub- hydrocolloid prepared by aqueous ex- stance comprised of one or more of the traction from the following members of

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the families Gigartinaceae and Solier- exist unless the standards provide for iaceae of the class Rodophyceae (red the use of carrageenan, or salts of car- seaweed): rageenan, combined with polysorbate 80. Chondrus crispus. Chondrus ocellatus. (e) The carrageenan and salts of car- Eucheuma cottonii. rageenan produced in accordance with Eucheuma spinosum. this section, and foods containing the Gigartina acicularis. same, in addition to the other require- Gigartina pistillata. ments of the Act, are labeled to show Gigartina radula. the presence of polysorbate 80, and the Gigartina stellata. label or labeling of the carrageenan (b) The food additive conforms to the and salts of carrageenan so produced following conditions: bear adequate directions for use. (1) It is a sulfated polysaccharide the dominant hexose units of which are ga- § 172.626 Salts of carrageenan. lactose and anhydrogalactose. The food additive salts of carra- (2) Range of sulfate content: 20 per- geenan may be safely used in food in cent to 40 percent on a dry-weight accordance with the following pre- basis. scribed conditions: (c) The food additive is used or in- (a) The food additive consists of car- tended for use in the amount necessary rageenan, meeting the provisions of for an emulsifier, stabilizer, or thick- § 172.620, modified by increasing the ener in foods, except for those stand- concentration of one of the naturally ardized foods that do not provide for occurring salts (ammonium, calcium, such use. potassium, or sodium) of carrageenan (d) To assure safe use of the additive, to the level that it is the dominant salt the label and labeling of the additive in the additive. shall bear the name of the additive, (b) The food additive is used or in- carrageenan. tended for use in the amount necessary for an emulsifier, stabilizer, or thick- § 172.623 Carrageenan with poly- ener in foods, except for those stand- sorbate 80. ardized foods that do not provide for Carrageenan otherwise meeting the such use. definition and specifications of § 172.620 (c) To assure safe use of the additive, (a) and (b) and salts of carrageenan the label and labeling of the additive otherwise meeting the definition of shall bear the name of the salt of car- § 172.626(a) may be safely produced with rageenan that dominates the mixture the use of polysorbate 80 meeting the by reason of the modification, e.g., specifications and requirements of ‘‘sodium carrageenan’’, ‘‘potassium § 172.840 (a) and (b) in accordance with carrageenan’’, etc. the following prescribed conditions: (a) The polysorbate 80 is used only to § 172.655 Furcelleran. facilitate separation of sheeted carra- The food additive furcelleran may be geenan and salts of carrageenan from safely used in food in accordance with drying rolls. the following prescribed conditions: (b) The carrageenan and salts of car- (a) The food additive is the refined rageenan contain not more than 5 per- hydrocolloid prepared by aqueous ex- cent by weight of polysorbate 80, and traction of furcellaria fastigiata of the the final food containing the additives class Rodophyceae (red seaweed). contains polysorbate 80 in an amount (b) The food additive conforms to the not to exceed 500 parts per million. following: (c) The carrageenan and salts of car- (1) It is a sulfated polysaccharide the rageenan so produced are used only in dominant hexose units of which are ga- producing foods in gel form and only lactose and anhydrogalactose. for the purposes defined in §§ 172.620(c) (2) Range of sulfate content: 8 per- and 172.626(b), respectively. cent to 19 percent, on a dry-weight (d) The carrageenan and salts of car- basis. rageenan so produced are not used in (c) The food additive is used or in- foods for which standards of identity tended for use in the amount necessary

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for an emulsifier, stabilizer, or thick- (c) The additive is produced by a ener in foods, except for those stand- process that renders it free of viable ardized foods that do not provide for cells of P. elodea. such use. (d) The additive meets the following (d) To assure safe use of the additive, specifications: the label and labeling of the additive (1) Positive for gellan gum when sub- shall bear the name of the additive, jected to the following identification furcelleran. tests: (i) A 1-percent solution is made by § 172.660 Salts of furcelleran. hydrating 1 gram of gellan gum in 99 milliliters of distilled water. The mix- The food additive salts of furcelleran ture is stirred for about 2 hours, using may be safely used in food in accord- a motorized stirrer and a propeller- ance with the following prescribed con- type stirring blade. A small amount of ditions: the above solution is drawn into a wide (a) The food additive consists of fur- bore pipet and transferred into a solu- celleran, meeting the provisions of tion of 10-percent calcium chloride. A § 172.655, modified by increasing the tough worm-like gel will form in- concentration of one of the naturally stantly. occurring salts (ammonium, calcium, (ii) To the 1-percent distilled water potassium, or sodium) of furcelleran to solution prepared for identification the level that it is the dominant salt in test (i), 0.50 gram of sodium chloride is the additive. added. The solution is heated to 80 °C (b) The food additive is used or in- with stirring, held at 80 °C for 1 tended for use in the amount necessary minute, and allowed to cool to room for an emulsifier, stabilizer, or thick- temperature without stirring. A firm ener in foods, except for those stand- gel will form. ardized foods that do not provide for (2) Residual isopropyl alcohol (IPA) such use. not to exceed 0.075 percent as deter- (c) To assure safe use of the additive, mined by the procedure described in the label and labeling of the additive the Xanthan Gum monograph, the shall bear the name of the salt of fur- ‘‘Food Chemicals Codex,’’ 4th ed. (1996), celleran that dominates the mixture by pp. 437–438, which is incorporated by reason of the modification, e.g., ‘‘so- reference in accordance with 5 U.S.C. dium furcelleran’’, ‘‘potassium furcel- 552(a) and 1 CFR part 51. Copies are leran’’, etc. available from the National Academy Press, Box 285, 2101 Constitution Ave. § 172.665 Gellan gum. NW., Washington, DC 20055 (Internet address http://www.nap.edu), or may be The food additive gellan gum may be examined at the Center for Food Safety safely used in food in accordance with and Applied Nutrition’s Library, Food the following prescribed conditions: and Drug Administration, 5100 Paint (a) The additive is a high molecular Branch Pkwy., College Park, MD 20740, weight polysaccharide gum produced or at the Office of the Federal Register, from Pseudomonas elodea by a pure cul- 800 North Capitol St. NW., suite 700, ture fermentation process and purified Washington, DC. by recovery with isopropyl alcohol. It (e) The additive is used or intended is composed of tetrasaccharide repeat for use in accordance with current good units, each containing one molecule of manufacturing practice as a stabilizer rhamnose and glucuronic acid, and two and thickener as defined in § 170.3(o)(28) molecules of glucose. The glucuronic of this chapter. The additive may be acid is neutralized to a mixed potas- used in foods where standards of iden- sium, sodium, calcium, and magnesium tity established under section 401 of salt. The polysaccharide may contain the Federal Food, Drug, and Cosmetic acyl (glyceryl and acetyl) groups as the Act do not preclude such use. O-glycosidically linked esters. (f) To assure safe use of the additive: (b) The strain of P. elodea is non- (1) The label of its container shall pathogenic and nontoxic in man and bear, in addition to other information animals. required by the Federal Food, Drug,

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and Cosmetic Act, the name of the ad- Set the beaker and its contents aside to ditive and the designation ‘‘food cool in the absence of agitation. Allow a grade’’. minimum time of 2 hours for cooling. Exam- (2) The label or labeling of the food ine the cooled beaker contents for a firm rubbery gel formation after the temperature additive container shall bear adequate drops below 40 °C. directions for use. In the event that a gel is obtained, make [55 FR 39614, Sept. 28, 1990, as amended at 57 up a 1 percent solution of the polysaccharide FR 55445, Nov. 25, 1992; 64 FR 1758, Jan. 12, to be tested in 200 milliliters of distilled 1999] water previously heated to 80 °C (omit the locust bean gum). Allow the solution to cool § 172.695 Xanthan gum. without agitation as before. Formation of a gel on cooling indicates that the sample is a The food additive xanthan gum may gelling polysaccharide and not xanthan gum. be safely used in food in accordance Record the sample as ‘‘positive’’ for xan- with the following prescribed condi- than gum if a firm, rubbery gel forms in the tions: presence of locust bean gum but not in its (a) The additive is a polysaccharide absence. Record the sample as ‘‘negative’’ for gum derived from Xanthomonas xanthan gum if no gel forms or if a soft or campestris by a pure-culture fermenta- brittle gel forms both with locust bean gum tion process and purified by recovery and in a 1 percent solution of the sample (containing no locust bean gum). with isopropyl alcohol. It contains D- glucose, D-mannose, and D-glucuronic (4) Positive for xanthan gum when acid as the dominant hexose units and subjected to the following procedure: is manufactured as the sodium, potassium, or calcium salt. PYRUVIC ACID TEST (b) The strain of Xanthomonas Pipet 10 milliliters of an 0.6 percent solu- campestris is nonpathogenic and tion of the polysaccharide in distilled water nontoxic in man or other animals. (60 milligrams of water-soluble gum) into a (c) The additive is produced by a 50-milliliter flask equipped with a standard process that renders it free of viable taper glass joint. Pipet in 20 milliliters of 1N cells of Xanthomonas campestris. hydrochloric acid. Weigh the flask. Reflux (d) The additive meets the following the mixture for 3 hours. Take precautions to avoid loss of vapor during the refluxing. Cool specifications: the solution to room temperature. Add dis- (1) Residual isopropyl alcohol not to tilled water to make up any weight loss from exceed 750 parts per million. the flask contents. (2) An aqueous solution containing 1 Pipet 1 milliliter of a 2,4-dinitrophenyl- percent of the additive and 1 percent of hydrazine reagent (0.5 percent in 2N hydro- potassium chloride stirred for 2 hours chloric acid) into a 30-milliliter separatory has a minimum viscosity of 600 centi- funnel followed by a 2-milliliter aliquot (4 poises at 75 °F, as determined by milligrams of water-soluble gum) of the Brookfield Viscometer, Model LVF (or polysaccharide hydrolyzate. Mix and allow the reaction mixture to stand at room tem- equivalent), using a No. 3 spindle at 60 perature for 5 minutes. Extract the mixture r.p.m., and the ratio of viscosities at 75 with 5 milliliters of ethyl acetate. Discard °F and 150 °F is in the range of 1.02 to the aqueous layer. 1.45. Extract the hydrazone from the ethyl ace- (3) Positive for xanthan gum when tate with three 5 milliliter portions of 10 per- subjected to the following procedure: cent sodium carbonate solution. Dilute the combined sodium carbonate extracts to 100 milliliters with additional 10 percent sodium LOCUST BEAN GUM GEL TEST carbonate in a 10-milliliter volumetric flask. Blend on a weighing paper or in a weighing Measure the optical density of the sodium pan 1.0 gram of powdered locust bean gum carbonate solution at 375 millimicrons. with 1.0 gram of the powdered polysaccharide Compare the results with a curve of the op- to be tested. Add the blend slowly (approxi- tical density versus concentration of an au- mately 1⁄2 minute) at the point of maximum thentic sample of pyruvic acid that has been agitation to a stirred solution of 200 milli- run through the procedure starting with the liters of distilled water previously heated to preparation of the hydrazone. 80 °C in a 400-milliliter beaker. Continue me- Record the percent by weight of pyruvic chanical stirring until the mixture is in solu- acid in the test polysaccharide. Note ‘‘position, but stir for a minimum time of 30 min- tive’’ for xanthan gum if the sample contains utes. Do not allow the water temperature to more than 1.5 percent of pyruvic acid and drop below 60 °C. ‘‘negative’’ for xanthan gum if the sample

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contains less than 1.5 percent of pyruvic acid the blend shall be in the range of 4–14 or 30– by weight. 70. (e) The additive is used or intended Ethylene dichloride. Polyglyceryl phthalate ester of coconut oil for use in accordance with good manu- fatty acids. facturing practice as a stabilizer, emul- a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]- sifier, thickener, suspending agent, omega-hydroxypoly(oxyethylene) produced bodying agent, or foam enhancer in by the condensation of 1 mole of p-(1,1,3,3- foods for which standards of identity tetramethylbutyl) phenol with an average of established under section 401 of the Act 4–14 or 30–70 moles of ethylene oxide; if a do not preclude such use. blend of products is used, the average num- (f) To assure safe use of the additive: ber of moles of ethylene oxide reacted to (1) The label of its container shall produce any product that is a component of bear, in addition to other information the blend shall be in the range of 4–14 or 30– 70. required by the Act, the name of the a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]- additive and the designation ‘‘food omega-hydroxypoly(oxyethylene) produced grade’’. by the condensation of 1 mole of p-(1,1,3,3- (2) The label or labeling of the food tetramethylbutyl) phenol with 1 mole of additive container shall bear adequate ethylene oxide. directions for use. Sodium acrylate and acrylamide copolymer with a minimum average molecular weight of 10,000,000 in which 30 percent of the Subpart H—Other Specific Usage polymer is comprised of acrylate units and 70 Additives percent acrylamide units, for use as a drift control agent in herbicide formulations ap- § 172.710 Adjuvants for pesticide use plied to crops at a level not to exceed 0.5 dilutions. ounces of the additive per acre. The following surfactants and related adjuvants may be safely added to pes- § 172.712 1,3-Butylene glycol. ticide use dilutions by a grower or ap- The food additive 1,3-butylene glycol plicant prior to application to the (CAS Reg. No. 107–88–0) may be safely growing crop: used in food in accordance with the following prescribed conditions: n-Alkyl (C8-C18) amine acetate, where the alkyl groups (C8-C18) are derived from coco- (a) It is prepared by the aldol con- nut oil, as a surfactant in emulsifier blends densation of acetaldehyde followed by at levels not in excess of 5 percent by weight catalytic hydrogenation. of the emulsifier blends that are added to (b) The food additive shall conform herbicides for application to corn and sorghum. to the identity and specifications listed in the monograph entitled ‘‘1,3-Butyl- Di-n-alkyl (C8-C18) dimethyl ammonium chloride, where the alkyl groups (C8-C18) are ene Glycol’’ in the Food Chemicals derived from coconut oil, as surfactants in Codex, 4th ed. (1996), p. 52, which is in- emulsifier blends at levels not in excess of 5 corporated by reference in accordance percent by weight of emulsifier blends that with 5 U.S.C. 552(a) and 1 CFR part 51. are added to herbicides for application to Copies are available from the Office of corn or sorghum. Premarket Approval, Center for Food Diethanolamide condensate based on a mixture of saturated and unsaturated soy- Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD bean oil fatty acids (C16-C18) as a surfactant in emulsifier blends that are added to the 20740, or may be examined at the Cen- herbicide atrazine for application to corn. ter for Food Safety and Applied Nutri- Diethanolamide condensate based on tion’s Library, Food and Drug Admin- stripped coconut fatty acids (C10 C18) as a istration, 5100 Paint Branch Pkwy., surfactant in emulsifier blends that are College Park, MD 20740, or at the Office added to the herbicide atrazine for applica- of the Federal Register, 800 North Cap- tion to corn. a-(p-Dodecylphenyl)-omega-hydroxypoly itol St. NW., suite 700, Washington, DC. (oxyethylene) produced by the condensation (c) It is used in the manufacture of of 1 mole of dodecylphenol (dodecyl group is sausage casings as a formulation aid as a proplyene tetramer isomer) with an aver- defined in § 170.3(o)(14) of this chapter age of 4–14 or 30–70 moles of ethylene oxide; and as a processing aid as defined in if a blend of products is used, the average § 170.3(o)(24) of this chapter. number of moles of ethylene oxide reacted to produce any product that is a component of [62 FR 26228, May 13, 1997]

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§ 172.715 Calcium lignosulfonate. 1–25, ‘‘Iodine Value of Fats and Oils Calcium lignosulfonate may be safely Wijs Method,’’ revised 1993, which is in- used in or on food, subject to the provi- corporated by reference in accordance sions of this section. with 5 U.S.C. 552(a) and 1 CFR part 51. (a) Calcium lignosulfonate consists of The availability of this incorporation sulfonated lignin, primarily as calcium by reference is given in paragraph and sodium salts. (b)(1) of this section. (b) It is used in an amount not to ex- (3) The heavy metals (as Pb) content ceed that reasonably required to ac- cannot be more than 10 parts per mil- complish the intended physical or tech- lion, as determined by the ‘‘Heavy Met- nical effect when added as a dispersing als Test,’’ of the ‘‘Food Chemicals agent and stabilizer in pesticides for Codex,’’ 4th ed. (1996), pp. 760–761, Meth- preharvest or postharvest application od II (with a 2-gram sample and 20 to bananas. microgram of lead ion in the control), which is incorporated by reference in § 172.720 Calcium lactobionate. accordance with 5 U.S.C. 552(a) and 1 The food additive calcium CFR part 51. Copies are available from lactobionate may be safely used in food the National Academy Press, Box 285, in accordance with the following pre- 2101 Constitution Ave. NW., Wash- scribed conditions: ington, DC 20055 (Internet address (a) The food additive is the calcium http://www.nap.edu), or may be exam- salt of lactobionic acid (4-(b,D- ined at the Center for Food Safety and galactosido)-D-gluconic acid) produced Applied Nutrition’s Library, Food and by the oxidation of lactose. Drug Administration, 5100 Paint (b) It is used or intended for use as a Branch Pkwy., College Park, MD 20740, firming agent in dry pudding mixes at or at the Office of the Federal Register, a level not greater than that required 800 North Capitol St. NW., suite 700, to accomplish the intended effect. Washington, DC. (c) The additive is used as a halogen § 172.723 Epoxidized soybean oil. stabilizer in brominated soybean oil at Epoxidized soybean oil may be safely a level not to exceed 1 percent. used in accordance with the following [60 FR 32903, June 26, 1995, as amended at 64 prescribed conditions: FR 1759, Jan. 12, 1999] (a) The additive is prepared by reacting soybean oil in toluene with hydro- § 172.725 Gibberellic acid and its po- gen peroxide and formic acid. tassium salt. (b) It meets the following specifica- The food additives gibberellic acid tions: and its potassium salt may be used in (1) Epoxidized soybean oil contains the malting of barley in accordance oxirane oxygen, between 7.0 and 8.0 percent, as determined by the American with the following prescribed condi- Oil Chemists’ Society (A.O.C.S.) meth- tions: od Cd 9–57, ‘‘Oxirane Oxygen,’’ re- (a) The additives meet the following approved 1989, which is incorporated by specifications: reference in accordance with 5 U.S.C (1) The gibberellic acid is produced 552(a) and 1 CFR part 51. Copies are by deep-culture fermentation of a suit- available from the American Oil Chem- able nutrient medium by a strain of ists’ Society, P. O. Box 3489, Cham- Fusarium moniliforme or a selection of paign, IL 61826–3489, or may be exam- this culture. ined at the Division of Petition Control (2) The gibberellic acid produced is of (HFS–215), Center for Food Safety and 80 percent purity or better. Applied Nutrition, Food and Drug Ad- (3) The empirical formula of ministration, 1110 Vermont Ave. NW., gibberellic acid is represented by suite 1200, Washington, DC, or at the C19H22O6. Office of the Federal Register, 800 (4) Potassium gibberellate is the po- North Capitol St. NW., suite 700, Wash- tassium salt of the specified gibberellic ington, DC. acid. (2) The maximum iodine value is 3.0, (5) The potassium gibberellate is of 80 as determined by A.O.C.S. method Cd percent purity or better.

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(6) The gibberellic acid or potassium whereby the amount of the additive gibberellate may be diluted with sub- present in the malt from the treatment stances generally recognized as safe in does not exceed 75 parts per million of foods or with salts of fatty acids con- bromate (calculated as Br), and the forming to § 172.863. treated malt is used only in the pro- (b) They are used or intended for use duction of fermented malt beverages or in the malting of barley under condi- distilled spirits. tions whereby the amount of either or (2) The total residue of inorganic bro- both additives present in the malt is mides in fermented malt beverages, re- not in excess of 2 parts per million ex- sulting from the use of the treated pressed as gibberellic acid, and the malt plus additional residues of inor- treated malt is to be used in the pro- ganic bromides that may be present duction of fermented malt beverages or distilled spirits only, whereby the fin- from uses in accordance with other reg- ished distilled spirits contain none and ulations in this chapter promulgated the finished malt beverage contains under sections 408 and/or 409 of the act, not more than 0.5 part per million of does not exceed 25 parts per million of gibberellic acid. bromide (calculated as Br). No toler- (c) To insure the safe use of the food ance is established for bromide in dis- additives the label of the package shall tilled spirits because there is evidence bear, in addition to the other informa- that inorganic bromides do not pass tion required by the Act: over in the distillation process. (1) The name of the additive, (b) To assure safe use of the additive, ‘‘gibberellic acid’’ or ‘‘potassium the label or labeling of the food addi- gibberellate’’, whichever is appro- tive shall bear, in addition to the other priate. information required by the Act, the (2) An accurate statement of the con- following: centration of the additive contained in (1) The name of the additive. the package. (2) Adequate directions for use. (3) Adequate use directions to provide (c) To assure safe use of the additive, not more than 2 parts per million of gibberellic acid in the finished malt. the label or labeling of the treated (4) Adequate labeling directions to malt shall bear, in addition to other in- provide that the final malt is properly formation required by the Act, the labeled as described in paragraph (d) of statement, ‘‘Brewer’s Malt—To be used this section. in the production of fermented malt (d) To insure the safe use of the addi- beverages only’’, or ‘‘Distiller’s Malt— tive the label of the treated malt shall To be used in the production of dis- bear, in addition to the other informa- tilled spirits only’’, whichever is the tion required by the Act, the state- case. ments: (1) ‘‘Contains not more than 2 parts § 172.735 Glycerol ester of wood rosin. per million lll’’, the blank being Glycerol ester of wood rosin may be filled in with the words ‘‘gibberellic safely used in food in accordance with acid’’ or ‘‘potassium gibberellate’’, the following prescribed conditions: whichever is appropriate; and (a) It has an acid number of 3 to 9, a (2) ‘‘Brewer’s malt—To be used in the drop-softening point of 88 °C–96 °C; and production of fermented malt bev- a color of N or paler as determined in erages only’’ or ‘‘Distiller’s malt—To be used in the production of distilled accordance with Official Naval Stores spirits only’’, whichever is appropriate. Standards of the United States. It is purified by countercurrent steam dis- § 172.730 Potassium bromate. tillation. The food additive potassium bromate (b) It is used to adjust the density of may be safely used in the malting of citrus oils used in the preparation of barley under the following prescribed beverages whereby the amount of the conditions: additive does not exceed 100 parts per (a)(1) It is used or intended for use in million of the finished beverage. the malting of barley under conditions

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§ 172.755 Stearyl monoglyceridyl cit- § 172.770 Ethylene oxide polymer. rate. The polymer of ethylene oxide may The food additive stearyl be safely used as a foam stabilizer in monoglyceridyl citrate may be safely fermented malt beverages in accord- used in food in accordance with the fol- ance with the following conditions. lowing provisions: (a) It is the polymer of ethylene (a) The additive is prepared by con- oxide having a minimum viscosity of trolled chemical reaction of the fol- 1,500 centipoises in a 1 percent aqueous lowing: solution at 25 °C. (b) It is used at a level not to exceed Reactant Limitations 300 parts per million by weight of the Citric acid ...... fermented malt beverage. Monoglycerides of fatty Prepared by the glycerolysis of ed- (c) The label of the additive bears di- acids. ible fats and oils or derived from fatty acids conforming with rections for use to insure compliance § 172.860. with paragraph (b) of this section. Stearyl alcohol...... Derived from fatty acids conforming with § 172.860, or de- § 172.775 Methacrylic acid- rived synthetically in conformity divinylbenzene copolymer. with § 172.864. Methacrylic acid-divinylbenzene co- (b) The additive stearyl polymer may be safely used in food in monoglyceridyl citrate, produced as accordance with the following pre- described under paragraph (a) of this scribed conditions: section, meets the following specifica- (a) The additive is produced by the tions: polymerization of methacrylic acid and Acid number 40 to 52. divinylbenzene. The divinylbenzene Total citric acid 15 to 18 percent. functions as a cross-linking agent and Saponification number 215–255. constitutes a minimum of 4 percent of the polymer. (c) The additive is used or intended (b) Aqueous extractives from the ad- for use as an emulsion stabilizer in or ditive do not exceed 2 percent (dry with shortenings containing emulsi- basis) after 24 hours at 25 °C. fiers. (c) The additive is used as a carrier of vitamin B in foods for special dietary § 172.765 Succistearin (stearoyl pro- 12 pylene glycol hydrogen succinate). use. The food additive succistearin (stearoyl propylene glycol hydrogen succi- Subpart I—Multipurpose Additives nate) may be safely used in food in ac- § 172.800 Acesulfame potassium. cordance with the following prescribed conditions: Acesulfame potassium (CAS Reg. No. (a) The additive is the reaction prod- 55589–62–3), also known as acesulfame uct of succinic anhydride, fully hydro- K, may be safely used as a general-pur- genated vegetable oil (predominantly pose sweetener and flavor enhancer in C16 or C18 fatty acid chain length), and foods generally, except in meat and propylene glycol. poultry, in accordance with current (b) The additive meets the following good manufacturing practice and in an specifications: amount not to exceed that reasonably required to accomplish the intended Acid number 50–150. technical effect in foods for which Hydroxyl number 15–50. standards of identity established under Succinated ester content 45–75 percent. section 401 of the Federal Food, Drug, (c) The additive is used or intended and Cosmetic Act do not preclude such for use as an emulsifier in or with use, under the following conditions: shortenings and edible oils intended for (a) Acesulfame potassium is the po- use in cakes, cake mixes, fillings, tassium salt of 6-methyl-1,2,3- icings, pastries, and toppings, in ac- oxathiazine-4(3H)-one-2,2-dioxide. cordance with good manufacturing (b) The additive meets the following practice. specifications:

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(1) Purity is not less than 99 percent quantity not more than sufficient for on a dry basis. The purity shall be de- such effect; and (2) as a dough-condi- termined by a method titled tioning agent in bread and roll produc- ‘‘Acesulfame Potassium Assay,’’ which tion at not to exceed the quantity of is incorporated by reference. Copies are hydrogen peroxide equivalent nec- available from the Center for Food essary for the artificial maturing ef- Safety and Applied Nutrition (HFS– fect. 200), Food and Drug Administration, (d) To insure safe use of the additive, 5100 Paint Branch Pkwy., College Park, the label of the food additive container MD 20740, or available for inspection at and any intermediate premix thereof the Office of the Federal Register, 800 shall bear, in addition to the other in- North Capitol Street, NW., suite 700, formation required by the act: Washington, DC 20408. (1) The name of the additive, ‘‘ace- (2) Fluoride content is not more than tone peroxides’’. 30 parts per million, as determined by (2) The concentration of the additive method III of the Fluoride Limit Test expressed in hydrogen peroxide equiva- of the Food Chemicals Codex, 3d Ed. lents per 100 grams. (1981), p. 511, which is incorporated by (3) Adequate use directions to provide reference. Copies are available from a final product that complies with the the National Academy Press, 2101 Con- limitations prescribed in paragraph (c) stitution Ave. NW., Washington, DC of this section. 20418, or available for inspection at the Office of the Federal Register, 800 § 172.804 Aspartame. North Capitol Street, NW., suite 700, The food additive aspartame may be Washington, DC 20408. safely used in food in accordance with (c) If the food containing the additive good manufacturing practice as a is represented to be for special dietary sweetening agent and a flavor enhancer uses, it shall be labeled in compliance in foods for which standards of identity with part 105 of this chapter. established under section 401 of the act [53 FR 28382, July 28, 1988, as amended at 57 do not preclude such use under the fol- FR 57961, Dec. 8, 1992; 59 FR 61540, 61543, 61545, lowing conditions: Dec. 1, 1994; 60 FR 21702, May 3, 1995; 63 FR (a) Aspartame is the chemical 1- 36362, July 6, 1998; 68 FR 75413, Dec. 31, 2003] methyl N-L-a-aspartyl-L-phenylalanine (C14H18N2O5). § 172.802 Acetone peroxides. (b) The additive meets the specifica- The food additive acetone peroxides tions of the ‘‘Food Chemicals Codex,’’ may be safely used in flour, and in 3d Ed. (1981) pp. 28–29 and First Supple- bread and rolls where standards of ment p. 5, which is incorporated by ref- identity do not preclude its use, in ac- erence in accordance with 5 U.S.C. cordance with the following prescribed 552(a). Copies are available from the conditions: National Academy Press, 2101 Constitu- (a) The additive is a mixture of tion Ave. NW., Washington, DC 20418, monomeric and linear dimeric acetone or may be examined at the Center for peroxide, with minor proportions of Food Safety and Applied Nutrition’s higher polymers, manufactured by re- Library, Food And Drug Administra- action of hydrogen peroxide and ace- tion, 5100 Paint Branch Pkwy., College tone. Park, MD 20740, or at the Office of the (b) The additive may be mixed with Federal Register, 800 North Capitol St. an edible carrier to give a concentra- NW., suite 700, Washington, DC. tion of: (1) 3 grams to 10 grams of hy- (c)(1) When aspartame is used as a drogen peroxide equivalent per 100 sugar substitute tablet for sweetening grams of the additive, plus carrier, for hot beverages, including coffee and tea, use in flour maturing and bleaching; or L-leucine may be used as a lubricant in (2) approximately 0.75 gram of hydro- the manufacture of such tablets at a gen peroxide equivalent per 100 grams level not to exceed 3.5 percent of the of the additive, plus carrier, for use in weight of the tablet. dough conditioning. (2) When aspartame is used in baked (c) It is used or intended for use: (1) goods and baking mixes, the amount of In maturing and bleaching of flour in a the additive is not to exceed 0.5 percent

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by weight of ready-to-bake products or (e) If the food containing the additive of finished formulations prior to bak- purports to be or is represented for spe- ing. Generally recognized as safe cial dietary uses, it shall be labeled in (GRAS) ingredients or food additives compliance with part 105 of this chap- approved for use in baked goods shall ter. be used in combination with aspartame to ensure its functionality as a sweet- [39 FR 27319, July 26, 1974] ener in the final baked product. The EDITORIAL NOTE: For FEDERAL REGISTER ci- level of aspartame used in these prod- tations affecting § 172.804, see the List of CFR ucts is determined by an analytical Sections Affected, which appears in the method entitled ‘‘Analytical Method Finding Aids section of the printed volume for the Determination of Aspartame and on GPO Access. and Diketopiperazine in Baked Goods § 172.806 Azodicarbonamide. and Baking Mixes,’’ October 8, 1992, which was developed by the Nutrasweet The food additive azodicarbonamide Co. Copies are available from the Office may be safely used in food in accord- of Premarket Approval (HFS–200), Cen- ance with the following prescribed con- ter for Food Safety and Applied Nutri- ditions: tion, 5100 Paint Branch Pkwy., College (a) It is used or intended for use: Park, MD 20740, or are available for in- (1) As an aging and bleaching ingre- spection at the Center for Food Safety dient in cereal flour in an amount not and Applied Nutrition’s Library, Food to exceed 2.05 grams per 100 pounds of and Drug Administration, 5100 Paint flour (0.0045 percent; 45 parts per mil- Branch Pkwy., College Park, MD 20740 lion). 20204, and the Office of the Federal (2) As a dough conditioner in bread Register, 800 North Capitol St. NW., baking in a total amount not to exceed suite 700, Washington, DC. 0.0045 percent (45 parts per million) by (d) To assure safe use of the additive, weight of the flour used, including any in addition to the other information re- quantity of azodicarbonamide added to quired by the Act: flour in accordance with paragraph (1) The principal display panel of any (a)(1) of this section. intermediate mix of the additive for (b) To assure safe use of the additive: manufacturing purposes shall bear a (1) The label and labeling of the addi- statement of the concentration of the tive and any intermediate premix pre- additive contained therein; pared therefrom shall bear, in addition (2) The label of any food containing to the other information required by the additive shall bear, either on the the Act, the following: principal display panel or on the infor- (i) The name of the additive. mation panel, the following statement: (ii) A statement of the concentration or the strength of the additive in any PHENYLKETONURICS: CONTAINS intermediate premixes. PHENYLALANINE (2) The label or labeling of the food The statement shall appear in the la- additive shall also bear adequate direc- beling prominently and conspicuously tions for use. as compared to other words, statements, designs or devices and in bold § 172.808 Copolymer condensates of type and on clear contrasting back- ethylene oxide and propylene oxide. ground in order to render it likely to Copolymer condensates of ethylene be read and understood by the ordinary oxide and propylene oxide may be safe- individual under customary conditions ly used in food under the following pre- of purchase and use. scribed conditions: (3) When the additive is used in a (a) The additive consists of one of the sugar substitute for table use, its label following: shall bear instructions not to use in (1) a-Hydro-omega-hydroxy-poly (oxy- cooking or baking. ethylene) poly(oxypropylene)-(55–61 (4) Packages of the dry, free-flowing moles)poly(oxyethylene) block copoly- additive shall prominently display the mer, having a molecular weight range sweetening equivalence in teaspoons of of 9,760–13,200 and a cloud point above sugar. 100 °C in 1 percent aqueous solution.

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(2) a-Hydro-omega-hydroxy-poly (oxy- tive dose not exceed 0.5 percent by ethylene)poly(oxypropylene)-(53–59 weight of the flour used. moles)poly(oxyethylene)(14–16 moles) [42 FR 14491, Mar. 15, 1977, as amended at 46 block copolymer, having a molecular FR 57476, Nov. 24, 1981] weight range of 3,500–4,125 and a cloud point of 9 °C–12 °C in 10 percent aqueous § 172.809 Curdlan. solution. Curdlan may be safely used in ac- (3) a-Hydro-omega-hydroxy-poly(ox- cordance with the following conditions: yethylene)/poly(oxypropylene) (min- (a) Curdlan is a high molecular imum 15 moles)/poly(oxyethylene) weight polymer of glucose (b-1,3- block copolymer, having a minimum glucan; CAS Reg. No. 54724–00–4) pro- average molecular weight of 1900 and a duced by pure culture fermentation minimum cloud point of 9 °C–12 °C in 10 from the nonpathogenic and percent aqueous solution. nontoxicogenic bacterium Alcaligenes (4) a-Hydro-omega-hydroxy-poly(ox- faecalis var. myxogenes. yethylene) poly (oxypropylene)-(51–57 (b) Curdlan meets the following spec- moles) poly(oxyethylene) block copoly- ifications when it is tested according mer, having an average molecular to the methods described or referenced weight of 14,000 and a cloud point above in the document entitled ‘‘Analytical 100 °C in 1 percent aqueous solution. Methods for Specification Tests for (b) The additive is used or intended Curdlan,’’ by Takeda Chemical Indus- for use as follows: tries, Ltd., 12–10 Nihonbashi, 2–Chome, (1) The additive identified in para- Chuo-ku, Tokyo, 103, Japan, 1996, which graph (a)(1) of this section is used in is incorporated by reference in accord- practice as a solubilizing and stabi- ance with 5 U.S.C. 552(a) and 1 CFR lizing agent in flavor concentrates part 51. Copies are available from the (containing authorized flavoring oils) Division of Petition Control (HFS–215), for use in foods for which standards of Center for Food Safety and Applied Nu- identity established under section 401 trition, Food and Drug Administration, of the Act do not preclude such use, 5100 Paint Branch Pkwy., College Park, provided that the weight of the addi- MD 20740, or may be examined at the tive does not exceed the weight of the Center for Food Safety and Applied Nu- flavoring oils in the flavor concentrate. trition’s Library, Food and Drug Ad- (2) The additive identified in para- ministration, 5100 Paint Branch Pkwy., graph (a)(2) of this section is used as a College Park, MD 20740, or at the Office processing aid and wetting agent in of the Federal Register, 800 North Cap- combination with dioctyl sodium sulfo- itol St. NW., suite 700, Washington, DC. succinate for fumaric acid as pre- (1) Positive for curdlan. scribed in § 172.810. (2) Assay for curdlan (calculated as (3) The additive identified in para- anhydrous glucose), not less than 80 graph (a)(3) of this section is used: percent. (i) As a surfactant and defoaming (3) pH of 1 percent aqueous suspen- agent, at levels not to exceed 0.05 persion, 6.0–7.5. cent by weight, in scald baths for poul- (4) Lead, not more than 0.5 mg/kg. try defeathering, followed by potable (5) Heavy metals (as Pb), not more water rinse. The temperatures of the than 0.002 percent. scald baths shall be not less than 125 (6) Total nitrogen, not more than 0.2 °F. percent. (ii) As a foam control and rinse adju- (7) Loss on drying, not more than 10 vant in hog dehairing machines at a percent. use level of not more than 5 grams per (8) Residue on ignition, not more hog. than 6 percent. (4) The additive identified in para- (9) Gel strength of 2 percent aqueous graph (a)(4) of this section is used as a suspension, not less than 600x103 dyne dough conditioner in yeast-leavened per square centimeter. bakery products for which standards of (10) Aerobic plate count, not more identity established under section 401 than 103 per gram. of the Act do not preclude such use, (11) Coliform bacteria, not more than provided that the amount of the addi- 3 per gram.

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(c) Curdlan is used or intended for (d) As an emulsifying agent for cocoa use in accordance with good manufac- fat in noncarbonated beverages con- turing practice as a formulation aid, taining cocoa, whereby the amount of processing aid, stabilizer and thick- the additive does not exceed 25 parts ener, and texturizer in foods for which per million of the finished beverage. standards of identity established under (e) As a dispersing agent in ‘‘cocoa section 401 of the act do not preclude with dioctyl sodium sulfosuccinate for such use. manufacturing’’ that conforms to the provisions of § 163.117 of this chapter [61 FR 65941, Dec. 16, 1996] and the use limitations prescribed in § 172.810 Dioctyl sodium sulfosuc- § 172.520, in an amount not to exceed 0.4 cinate. percent by weight thereof. (f) As a processing aid and wetting The food additive dioctyl sodium agent in combination with a-hydro- sulfosuccinate, which meets the speci- omega -hydroxy - poly(oxyethylene) - fications of the Food Chemicals Codex, poly-(oxypropylene) (53–59 moles) 3d Ed. (1981), pp. 102–104, which is incor- poly(oxyethylene) (14–16 moles) block porated by reference (copies may be ob- copolymer, having a molecular weight tained from the National Academy range of 3,500–4,125 and a cloud point of Press, 2101 Constitution Ave. NW., 9 °C–12 °C in 10 percent aqueous solu- Washington, DC 20418, or may be exam- tion, for fumaric acid used in fumaric ined at the Office of the Federal Reg- acid-acidulated dry beverage base and ister, 800 North Capitol Street, NW., in fumaric acid-acidulated fruit juice suite 700, Washington, DC 20408), may drinks, when standards of identity do be safely used in food in accordance not preclude such use. The labeling of with the following prescribed condi- the dry beverage base shall bear ade- tions: quate directions for use, and the addi- (a) As a wetting agent in the fol- tives shall be used in such an amount lowing fumaric acid-acidulated foods: that the finished beverage or fruit juice Dry gelatin dessert, dry beverage base, drink will contain not in excess of a and fruit juice drinks, when standards total of 10 parts per million of the of identity do not preclude such use. dioctyl sodium sulfosuccinate-block The labeling of the dry gelatin dessert copolymer combination. and dry beverage base shall bear adequate directions for use, and the addi- [42 FR 14491, Mar. 15, 1977, as amended at 49 tive shall be used in such an amount FR 10105, Mar. 19, 1984] that the finished gelatin dessert will § 172.811 Glyceryl tristearate. contain not in excess of 15 parts per million of the additive and the finished The food additive glyceryl tristearate beverage or fruit juice drink will con- may be safely used in food in accord- tain not in excess of 10 parts per mil- ance with the following prescribed con- lion of the additive. ditions: (b) As a processing aid in sugar fac- (a) The food additive (CAS Reg. No. tories in the production of unrefined 555–43–1) is prepared by reacting stearic cane sugar, in an amount not in excess acid with glycerol in the presence of a of 0.5 part per million of the additive suitable catalyst. per percentage point of sucrose in the (b) The food additive meets the fol- juice, syrup, or massecuite being proc- lowing specifications: essed, and so used that the final molas- Acid number: Not to exceed 1.0. ses will contain no more than 25 parts Iodine number: Not to exceed 1.0. per million of the additive. Saponification number: 186–192. (c) As a solubilizing agent on gums Hydroxyl number: Not to exceed 5.0. and hydrophilic colloids to be used in Free glycerol content: Not to exceed 0.5 per- food as stabilizing and thickening cent. agents, when standards of identity do Unsaponifiable matter: Not to exceed 0.5 percent. not preclude such use. The additive is ° ° used in an amount not to exceed 0.5 Melting point (Class II): 69 C–73 C. percent by weight of the gums or hy- (c) The additive is used or intended drophilic colloids. for use as follows when standards of

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identity established under section 401 Uses Limitations of the Act do not preclude such use: As a masking agent for the Not to exceed 0.2 percent in bitter aftertaste of sac- the finished beverage. Uses Limitations charin used in manufactured beverages and bev- 1. As a crystallization accel- Not to exceed 1 percent of erage bases. erator in cocoa products, in the combined weight of imitation chocolate, and in the formulation. As a stabilizer in mono- and Not to exceed 0.02 percent of compound coatings. diglycerides prepared by the mono- and the glycerolysis of edible diglycerides. 2. As a formulation aid as de- Not to exceed 0.5 percent. fats or oils. fined in § 170.3(o)(14) of this chapter, lubricant and release agent as defined in (c) To assure safe use of the additive, § 170.3(o)(18) of this chapter, in addition to the other information re- and surface-finishing agent as defined in § 170.3(o)(30) of quired by the Act: this chapter in food. (1) The labeling of the additive shall 3. As a formulation aid as de- Not to exceed 3.0 percent bear adequate directions for use of the fined in § 170.3(o)(14) of this of the combined weight chapter in confections. of the formulation. additive in compliance with the provi- 4. As a formulation aid as de- Not to exceed 1.0 percent sions of this section. fined in § 170.3(o)(14) of this of the combined weight (2) The labeling of beverage bases chapter in fats and oils as de- of the formulation. fined in § 170.3 (n)(12) of this containing the additive shall bear ade- chapter. quate directions for use to provide that 5. As a winterization and frac- Not to exceed 0.5 percent beverages prepared therefrom shall tionation aid in fat and oil by weight of the proc- processing. essed fat or oil. contain no more than 0.2 percent glycine. (d) To assure safe use of the additive: [42 FR 14491, Mar. 15, 1977, as amended at 49 (1) In addition to the other informa- FR 10105, Mar. 19, 1984] tion required by the act, the label or labeling of the additive shall bear the § 172.814 Hydroxylated lecithin. name of the additive. The food additive hydroxylated (2) The label of the additive shall lecithin may be safely used as an emul- bear adequate directions to provide a sifier in foods in accordance with the final product that complies with the following conditions: limitations prescribed in paragraph (c) (a) The additive is obtained by the of this section. treatment of lecithin in one of the fol- [53 FR 21632, June 9, 1988, as amended at 59 lowing ways, under controlled condi- FR 24924, May 13, 1994] tions whereby the separated fatty acid fraction of the resultant product has § 172.812 Glycine. an acetyl value of 30 to 38: The food additive glycine may be (1) With hydrogen peroxide, benzoyl safely used for technological purposes peroxide, lactic acid, and sodium hy- in food in accordance with the fol- droxide. lowing prescribed conditions: (2) With hydrogen peroxide, acetic (a) The additive complies with the acid, and sodium hydroxide. specifications of the ‘‘Food Chemicals (b) It is used or intended for use, in Codex,’’ 3d Ed. (1981), p. 140, which is in- accordance with good manufacturing corporated by reference. Copies may be practice, as an emulsifier in foods, ex- obtained from the National Academy cept for those standardized foods that Press, 2101 Constitution Ave. NW., do not provide for such use. Washington, DC 20418, or may be exam- (c) To assure safe use of the additive, ined at the Office of the Federal Reg- the label of the food additive container ister, 800 North Capitol Street, NW., shall bear, in addition to the other in- suite 700, Washington, DC 20408. formation required by the Act: (b) The additive is used or intended (1) The name of the additive, for use as follows: ‘‘hydroxylated lecithin’’. (2) Adequate directions for its use.

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§ 172.816 Methyl glucoside-coconut oil the limitations prescribed in paragraph ester. (b) of this section. Methyl glucoside-coconut oil ester § 172.820 Polyethylene glycol (mean may be safely used in food in accord- molecular weight 200–9,500). ance with the following conditions: (a) It is the methyl glucoside-coconut Polyethylene glycol identified in this oil ester having the following specifica- section may be safely used in food in tions: accordance with the following prescribed conditions: Acid number: 10–20 (a) Identity. (1) The additive is an ad- Hydroxyl number: 200–300 dition polymer of ethylene oxide and pH (5% aqueous): 4.8–5.0 water with a mean molecular weight of Saponification number: 178–190 200 to 9,500. (b) It is used or intended for use as (2) It contains no more than 0.2 per- follows: cent total by weight of ethylene and (1) As an aid in crystallization of su- diethylene glycols when tested by the crose and dextrose at a level not to ex- analytical methods prescribed in para- ceed the minimum quantity required to graph (b) of this section. produce its intended effect. (b) Analytical method. (1) The analyt- (2) As a surfactant in molasses at a ical method prescribed in the National level not to exceed 320 parts per million Formulary XV (1980), page 1244, for pol- in the molasses. yethylene glycol 400 shall be used to determine the total ethylene and § 172.818 Oxystearin. diethylene glycol content of poly- The food additive oxystearin may be ethylene glycols having mean molec- safely used in foods, when such use is ular weights of 450 or higher. not precluded by standards of identity (2) The following analytical method in accordance with the following condi- shall be used to determine the total tions: ethylene and diethylene glycol content (a) The additive is a mixture of the of polyethylene glycols having mean glycerides of partially oxidized stearic molecular weights below 450. and other fatty acids obtained by heating hydrogenated cottonseed or soy- ANALYTICAL METHOD bean oil under controlled conditions, in the presence of air and a suitable cata- ETHYLENE GLYCOL AND DIETHYLENE GLYCOL CONTENT OF POLYETHYLENE GLYCOLS lyst which is not a food additive as so defined. The resultant product meets The analytical method for determining the following specifications: ethylene glycol and diethylene glycol is as follows: Acid number: Maximum 15. Iodine number: Maximum 15. APPARATUS Saponification number: 225–240. Gas chromatograph with hydrogen flame Hydroxyl number: 30–45. ionization detector (Varian Aerograph 600 D Unsaponifiable material: Maximum 0.8 per- or equivalent). The following conditions cent. shall be employed with the Varian ± ° Refractive index (butyro): 60 1 at 48 C. Aerograph 600 D gas chromatograph: (b) It is used or intended for use as a Column temperature: 165 °C. ° crystallization inhibitor in vegetable Inlet temperature: 260 C. Carrier gas (nitrogen) flow rate: 70 milli- oils and as a release agent in vegetable liters per minute. oils and vegetable shortenings, where- Hydrogen and air flow to burner: Optimize by the additive does not exceed 0.125 to give maximum sensitivity. percent of the combined weight of the Sample size: 2 microliters. oil or shortening. Elution time: Ethylene glycol: 2.0 minutes. (c) To insure safe use of the additive, Diethylene glycol: 6.5 minutes. the label and labeling of the additive Recorder: ¥0.5 to +1.05 millivolt, full span, container shall bear, in addition to the 1 second full response time. Syringe: 10-microliter (Hamilton 710 N or other information required by the Act: equivalent). (1) The name of the additive. Chromatograph column: 5 feet × 1⁄8 inch. (2) Adequate directions to provide an I.D. stainless steel tube packed with sorbitol oil or shortening that complies with (Mathieson-Coleman-Bell 2768 Sorbitol

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SX850, or equivalent) 12 percent in H2O by (3) As an adjuvant in dispersing vita- weight on 60–80 mesh nonacid washed diato- min and/or mineral preparations. maceous earth (Chromosorb W. Johns-Man- (4) As a coating on sodium nitrite to ville, or equivalent). inhibit hygroscopic properties. REAGENTS AND MATERIALS (d) Limitations. (1) It is used in an amount not greater than that required Carrier gas, nitrogen: Commercial grade in cylinder equipped with reducing regulator to to produce the intended physical or provide 50 p.s.i.g. to the gas chromatograph. technical effect. Ethylene glycol: Commercial grade. Purify (2) A tolerance of zero is established if necessary, by distillation. for residues of polyethylene glycol in Diethylene glycol: Commercial grade. Pu- milk. rify, if necessary, by distillation. Glycol standards: Prepare [42 FR 14491, Mar. 15, 1977, as amended at 49 chromatographic standards by dissolving FR 10105, Mar. 19, 1984] known amounts of ethylene glycol and diethylene glycol in water. Suitable con- § 172.822 Sodium lauryl sulfate. centrations for standardization range from 1 The food additive sodium lauryl sul- to 6 milligrams of each component per milli- fate may be safely used in food in ac- liter (for example 10 milligrams diluted to cordance with the following conditions: volume in a 10-milliliter volumetric flask is equivalent to 1 milligram per milliliter). (a) The additive meets the following specifications: STANDARDIZATION (1) It is a mixture of sodium alkyl Inject a 2-microliter aliquot of the glycol sulfates consisting chiefly of sodium standard into the gas chromatograph em- lauryl sulfate [CH2(CH2)10CH2OSO2Na]. ploying the conditions described above. (2) It has a minimum content of 90 Measure the net peak heights for the ethyl- percent sodium alkyl sulfates. ene glycol and for the diethylene glycol. (b) It is used or intended for use: Record the values as follows: (1) As an emulsifier in or with egg A=Peak height in millimeters of the ethyl- whites whereby the additive does not ene glycol peak. B=milligrams of ethylene glycol per milli- exceed the following limits: liter of standard solution. Egg white solids, 1,000 parts per million. C=Peak height in millimeters of the Frozen egg whites, 125 parts per million. diethylene glycol peak. Liquid egg whites, 125 parts per million. D=Milligrams of diethylene glycol per milliliter of standard solution. (2) As a whipping agent at a level not to exceed 0.5 percent by weight of gela- PROCEDURE tine used in the preparation of marsh- Weigh approximately 4 grams of poly- mallows. ethylene glycol sample accurately into a 10- (3) As a surfactant in: milliliter volumetric flask. Dilute to volume (i) Fumaric acid-acidulated dry bev- with water. Mix the solution thoroughly and erage base whereby the additive does inject a 2-microliter aliquot into the gas not exceed 25 parts per million of the chromatograph. Measure the heights, in millimeters, of the ethylene glycol peak and of finished beverage and such beverage the diethylene glycol peak and record as E base is not for use in a food for which and F, respectively. a standard of identity established under section 401 of the Act precludes Percent ethylene glycol=(E×B)/(A×sample weight in grams) such use. (ii) Fumaric acid-acidulated fruit Percent diethylene glycol=(F×D)/(C×sample juice drinks whereby the additive does weight in grams) not exceed 25 parts per million of the (c) Uses. It may be used, except in finished fruit juice drink and it is not milk or preparations intended for addi- used in a fruit juice drink for which a tion to milk, as follows: standard of identity established under (1) As a coating, binder, plasticizing section 401 of the Act precludes such agent, and/or lubricant in tablets used use. for food. (4) As a wetting agent at a level not (2) As an adjuvant to improve flavor to exceed 10 parts per million in the and as a bodying agent in nonnutritive partition of high and low melting frac- sweeteners identified in § 180.37 of this tions of crude vegetable oils and ani- chapter. mal fats, provided that the partition

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step is followed by a conventional re- § 172.826 Sodium stearyl fumarate. fining process that includes alkali neu- Sodium stearyl fumarate may be tralization and deodorization of the safely used in food in accordance with fats and oils. the following conditions: (c) To insure the safe use of the addi- (a) It contains not less than 99 per- tive, the label of the food additive con- cent sodium stearyl fumarate cal- tainer shall bear, in addition to the culated on the anhydrous basis, and other information required by the Act: not more than 0.25 percent sodium ste- (1) The name of the additive, sodium aryl maleate. lauryl sulfate. (b) The additive is used or intended (2) Adequate use directions to provide for use: a final product that complies with the (1) As a dough conditioner in yeast- limitations prescribed in paragraph (b) leavened bakery products in an amount of this section. not to exceed 0.5 percent by weight of [42 FR 14491, Mar. 15, 1977, as amended at 43 the flour used. FR 18668, May 2, 1978] (2) As a conditioning agent in dehydrated potatoes in an amount not to § 172.824 Sodium mono- and dimethyl exceed 1 percent by weight thereof. naphthalene sulfonates. (3) As a stabilizing agent in The food additive sodium mono- and nonyeast-leavened bakery products in dimethyl naphthalene sulfonates may an amount not to exceed 1 percent by be safely used in accordance with the weight of the flour used. following prescribed conditions: (4) As a conditioning agent in proc- (a) The additive has a molecular essed cereals for cooking in an amount weight range of 245–260. not to exceed 1 percent by weight of (b) The additive is used or intended the dry cereal, except for foods for for use: which standards of identity preclude (1) In the crystallization of sodium such use. carbonate in an amount not to exceed (5) As a conditioning agent in starch- 250 parts per million of the sodium car- thickened or flour-thickened foods in bonate. Such sodium carbonate is used an amount not to exceed 0.2 percent by or intended for use in potable water weight of the food. systems to reduce hardness and aid in sedimentation and coagulation by rais- § 172.828 Acetylated monoglycerides. ing the pH for the efficient utilization of other coagulation materials. The food additive acetylated monoglycerides may be safely used in (2) As an anticaking agent in sodium or on food in accordance with the fol- nitrite at a level not in excess of 0.1 percent by weight thereof for author- lowing prescribed conditions: ized uses in cured fish and meat. (a) The additive is manufactured by: (c) In addition to the general labeling (1) The interesterification of edible requirements of the Act: fats with triacetin and in the presence (1) Sodium carbonate produced in ac- of catalytic agents that are not food cordance with paragraph (b)(1) of this additives or are authorized by regula- section shall be labeled to show the tion, followed by a molecular distilla- presence of the additive and its label or tion or by steam stripping; or labeling shall bear adequate directions (2) The direct acetylation of edible for use. monoglycerides with acetic anhydride (2) Sodium nitrite produced in ac- without the use of catalyst or molec- cordance with paragraph (b)(2) of this ular distillation, and with the removal section shall bear the labeling required by vacuum distillation, if necessary, of by § 172.175 and a statement declaring the acetic acid, acetic anhydride, and the presence of sodium mono- and di- triacetin. methyl naphthalene sulfonates. (b) The food additive has a Reichert- Meissl value of 75–200 and an acid value [42 FR 14491, Mar. 15, 1977, as amended at 63 of less than 6. FR 7069, Feb. 12, 1998]

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(c) The food additive is used at a ance with current good manufacturing level not in excess of the amount rea- practice, in an amount not to exceed sonably required to produce its in- that reasonably required to accomplish tended effect in food, or in food-proc- the intended technical effect, in foods essing, food-packing, or food-storage for which standards of identity estab- equipment. lished under section 401 of the Federal [42 FR 14491, Mar. 15, 1977, as amended at 50 Food, Drug, and Cosmetic Act do not FR 3508, Jan. 25, 1985] preclude such use. (d) When neotame is used as a sugar § 172.829 Neotame. substitute tablet, L-leucine may be (a) Neotame is the chemical N-[N- used as a lubricant in the manufacture (3,3-dimethylbutyl)-L-a-aspartyl]-L- of tablets at a level not to exceed 3.5 phenylalanine-1-methyl ester (CAS percent of the weight of the tablet. Reg. No. 165450–17–9). (e) If the food containing the additive (b) Neotame meets the following purports to be or is represented to be specifications when it is tested accord- for special dietary use, it shall be la- ing to the methods described or ref- beled in compliance with part 105 of erenced in the document entitled this chapter. ‘‘Specifications and Analytical Meth- [67 FR 45310, July 9, 2002] ods for Neotame’’ dated April 3, 2001, by the NutraSweet Co., 699 North § 172.830 Succinylated monoglycerides. Wheeling Rd., Mount Prospect, IL The food additive succinylated 60056. The Director of the Office of the monoglycerides may be safely used in Federal Register has approved the in- food in accordance with the following corporation by reference of this mate- prescribed conditions: rial in accordance with 5 U.S.C. 552(a) (a) The additive is a mixture of semi- and 1 CFR part 51. Copies are available and neutral succinic acid esters of from the Office of Food Additive Safety mono- and diglycerides produced by the (HFS–200), Center for Food Safety and succinylation of a product obtained by Applied Nutrition, 5100 Paint Branch the glycerolysis of edible fats and oils, Pkwy., College Park, MD 20740. Copies or by the direct esterification of glyc- may be examined at the Center for erol with edible fat-forming fatty Food Safety and Applied Nutrition’s acids. Library, 5100 Paint Branch Pkwy., rm. (b) The additive meets the following 1C–100, College Park, MD 20740, or at specifications: the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Wash- Succinic acid content: 14.8%–25.6% Melting point: 50 °C–60 °C. ington, DC 20001. Acid number: 70–120 (1) Assay for neotame, not less than 97.0 percent and not more than 102.0 (c) The additive is used or intended percent on a dry basis. for use in the following foods: (2) Free dipeptide acid (N-[N-(3,3- (1) As an emulsifier in liquid and dimethylbutyl)-L-a-aspartyl]-L- plastic shortenings at a level not to ex- phenylalanine), not more than 1.5 per- ceed 3 percent by weight of the short- cent. ening. (3) Other related substances, not (2) As a dough conditioner in bread more than 2.0 percent. baking, when such use is permitted by (4) Lead, not more than 2.0 milli- an appropriate food standard, at a level grams per kilogram. not to exceed 0.5 percent by weight of (5) Water, not more than 5.0 percent. the flour used. (6) Residue on ignition, not more than 0.2 percent § 172.831 Sucralose. (7) Specific rotation, determined at (a) Sucralose is the chemical 1,6- 20 °C [a]D: ¥40.0° to 43.4° calculated on dichloro-1,6-dideoxy-β-D- a dry basis. fructofuranosyl-4-chloro-4-deoxy-α-D- (c) The food additive neotame may be galactopyranoside (CAS Reg. No. 56038– safely used as a sweetening agent and 13–2). flavor enhancer in foods generally, ex- (b) The additive meets the specifica- cept in meat and poultry, in accord- tions of the ‘‘Food Chemicals Codex,’’

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4th ed. (1996), pp. 398–400, which is in- lowed, will result in a food that com- corporated by reference in accordance plies with the requirements of this sec- with 5 U.S.C. 552(a) and 1 CFR part 51. tion. Copies are available from the the Divi- sion of Product Policy (HFS–206), Cen- § 172.833 Sucrose acetate isobutyrate ter for Food Safety and Applied Nutri- (SAIB). tion, Food and Drug Administration, Sucrose acetate isobutyrate may be 5100 Paint Branch Pkwy., College Park, safely used in foods in accordance with MD 20740, or may be examined at the the following prescribed conditions: Center for Food Safety and Applied Nu- (a) Sucrose acetate isobutyrate (CAS trition’s Library, 5100 Paint Branch Reg. No. 27216–37–1), or SAIB, is the Pkwy., College Park, MD 20740 20204– 0001, or the Office of the Federal Reg- chemical alpha-D-glucopyranoside, O- ister, 800 North Capitol St. NW., suite acetyl-tris-O-(2-methyl-1-oxopropyl)- 700, Washington, DC. beta-D-fructofuranosyl, acetate tris(2- (c) The additive may be used as a methyl propanoate). sweetener in foods generally, in accord- (b) SAIB, a pale, straw-colored liquid, ance with current good manufacturing meets the following specifications: (1) practice in an amount not to exceed Assay: Not less than 98.8 percent and that reasonably required to accomplish not more than 101.9 percent, based on the intended effect. the following formula: (d) If the food containing the additive Assay = ((SV 0.10586) ÷ 56.1) × 100 purports to be or is represented to be Where SV = Saponification value for special dietary use, it shall be la- (2) Saponification value: 524–540 de- beled in compliance with part 105 of termined using 1 gram of sample by the this chapter. ‘‘Guide to Specifications for General [63 FR 16433, Apr. 3, 1998, as amended at 64 Notices, General Analytical Tech- FR 43909, Aug. 12, 1999] niques, Identification Tests, Test Solu- tions, and Other Reference Materials,’’ § 172.832 Monoglyceride citrate. in the ‘‘Compendium of Food Additive A food additive that is a mixture of Specifications, Addendum 4, Food and glyceryl monooleate and its citric acid Agriculture Organization of the United monoester manufactured by the reac- Nations (FAO), Food and Nutrition tion of glyceryl monooleate with citric Paper 5, Revision 2’’ (1991), pp. 203 and acid under controlled conditions may 204, which is incorporated by reference, be safely used as a synergist and solu- in accordance with 5 U.S.C. 552(a) and 1 bilizer for antioxidants in oils and fats, CFR part 51. Copies are available from when used in accordance with the con- the Office of Premarket Approval, Cen- ditions prescribed in this section. ter for Food Safety and Applied Nutri- (a) The food additive meets the fol- tion (HFS–200), Food and Drug Admin- lowing specifications: istration, 5100 Paint Branch Pkwy., Acid number, 70–100. College Park, MD 20740, or may be ex- Total citric acid (free and combined), 14 per- amined at the Center for Food Safety cent–17 percent. and Applied Nutrition’s Library, 5100 (b) It is used, or intended for use, in Paint Branch Pkwy., College Park, MD antioxidant formulations for addition 20740, or at the Office of the Federal to oils and fats whereby the additive Register, 800 North Capitol St. NW., does not exceed 200 parts per million of suite 700, Washington, DC. the combined weight of the oil or fat (3) Acid value: Not to exceed 0.20 de- and the additive. termined using 50 grams of sample by (c) To assure safe use of the additive: the ‘‘Guide to Specifications for Gen- (1) The container label shall bear, in eral Notices, General Analytical Tech- addition to the other information re- niques, Identification Tests, Test Solu- quired by the Act, the name of the ad- tions, and Other Reference Materials,’’ ditive. in the ‘‘Compendium of Food Additive (2) The label or accompanying labeling shall bear adequate directions for Specifications, Addendum 4, FAO Food the use of the additive which, if fol- and Nutrition Paper 5, Revision 2,’’ p.

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189 (1991), which is incorporated by ref- (1) Glycerolysis of edible fats pri- erence; see paragraph (b)(2) of this sec- marily composed of stearic, palmitic, tion for availability of the incorpora- and myristic acids; or tion by reference. (2) Direct esterification of glycerol (4) Lead: Not to exceed 1.0 milli- with a mixture of primarily stearic, grams/kilogram determined by the palmitic, and myristic acids; ‘‘Atomic Absorption to yield a product with less than 0.3 Spectrophotometric Graphite Furnace acid number and less than 0.2 percent Method, Method I,’’ in the ‘‘Food water, which is then reacted with Chemicals Codex,’’ 4th ed. (1996), pp. 763 ethylene oxide. and 764, with an attached modification (b) The additive meets the following to the sample digestion section in Ap- specifications: pendix III.B (July 1996), which is incorporated by reference. Copies are avail- Saponification number, 65–75. able from the National Academy Press, Acid number, 0–2. 2101 Constitution Ave. NW., Box 285, Hydroxyl number, 65–80. Washington, DC 20055 (Internet http:// Oxyethylene content, 60.5–65.0 percent. www.nap.edu), or may be examined at (c) The additive is used or intended the Center for Food Safety and Applied for use in the following foods when Nutrition’s Library, 5100 Paint Branch standards of identity established under Pkwy., College Park, MD 20740, or at section 401 of the Act do not preclude the Office of the Federal Register, 800 such use: North Capitol St. NW., suite 700, Wash- ington, DC. Use Limitations (5) Triacetin: Not to exceed 0.10 per- 1. As an emulsifier in pan-re- Not to exceed levels required cent determined by gas chroma- lease agents for and as a to produce the intended ef- tography as described in the ‘‘Guide to dough conditioner in yeast- fects, total not to exceed leavened bakery products. 0.5 percent by weight of Specifications for General Notices, the flour used. General Analytical Techniques, Identi- 2. As an emulsifier in cakes Not to exceed 0.5 percent by fication Tests, Test Solutions, and and cake mixes. weight of the dry ingredients. Other Reference Materials,’’ in the 3. As an emulsifier in Not to exceed 0.45 percent ‘‘Compendium of Food Additive Speci- whipped vegetable oil top- by weight of the finished fications, Addendum 4, FAO Food and pings and topping mixes. whipped vegetable oil toppings. Nutrition Paper 5, Revision 2,’’ (1991), 4. As an emulsifier in icings Not to exceed 0.5 percent by pp. 13–26, which is incorporated by ref- and icing mixes. weight of the finished erence; see paragraph (b)(2) of this sec- icings. tion for availability of the incorpora- 5. As an emulsifier in frozen Not to exceed 0.2 percent by desserts. weight of the finished fro- tion by reference. zen desserts. (c) The food additive is used as a sta- 6. As an emulsifier in edible Not to exceed 0.4 percent by bilizer (as defined in § 170.3(o)(28) of this vegetable fat-water emul- weight of the finished vege- sions intended for use as table fat-water emulsions. chapter) of emulsions of flavoring oils substitutes for milk or in nonalcoholic beverages. cream in beverage coffee. (d) The total SAIB content of a beverage containing the additive does not (d) When the name ‘‘polyglycerate exceed 300 milligrams/kilogram of the 60’’ is used in labeling it shall be fol- finished beverage. lowed by either ‘‘polyoxyethylene (20) mono-and diglycerides of fatty acids’’ [64 FR 29958, June 4, 1999; 64 FR 43072, Aug. 9, 1999] or ‘‘ethoxylated mono- and diglycerides’’ in parentheses. § 172.834 Ethoxylated mono- and [42 FR 14491, Mar. 15, 1977, as amended at 42 diglycerides. FR 37973, July 26, 1977; 50 FR 49536, Dec. 3, The food additive ethoxylated mono- 1985] and diglycerides (polyoxyethylene (20) mono- and diglycerides of fatty acids) § 172.836 Polysorbate 60. (polyglycerate 60) may be safely used The food additive polysorbate 60 in food in accordance with the fol- (polyoxyethylene (20) sorbitan mono- lowing prescribed conditions: stearate) which is a mixture of (a) The food additive is manufactured polyoxyethylene ethers of mixed par- by: tial stearic and palmitic acid esters of

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sorbitol anhydrides and related com- in nonstandardized confectionery coat- pounds, may be safely used in food in ings and standardized cacao products accordance with the following pre- specified in §§ 163.123, 163.130, 163.135, scribed conditions: 163.140, 163.145, and 163.150 of this chap- (a) The food additive is manufactured ter, as follows: by reacting stearic acid (usually con- (i) It is used alone in an amount not taining associated fatty acids, chiefly to exceed 0.5 percent of the weight of palmitic) with sorbitol to yield a prod- the finished nonstandardized confec- uct with a maximum acid number of 10 tionery coating or standardized cacao and a maximum water content of 0.2 product. percent, which is then reacted with (ii) It is used with sorbitan mono- ethylene oxide. stearate in any combination of up to (b) The food additive meets the fol- 0.5 percent of polysorbate 60 and up to lowing specifications: 1 percent of sorbitan monostearate: Provided, That the total combination Saponification number 45–55. Acid number 0–2. does not exceed 1 percent of the weight Hydroxyl number 81–96. of the finished nonstandardized confec- Oxyethylene content 65 percent–69.5 percent. tionery coating or standardized cacao product. (c) It is used or intended for use as (4) [Reserved] follows: (5) As an emulsifier in cake icings (1) As an emulsifier in whipped edible and cake fillings, with or without one oil topping with or without one or a or a combination of the following: combination of the following: (i) Polysorbate 65. (i) Sorbitan monostearate; (ii) Sorbitan monostearate. (ii) Polysorbate 65; (iii) Polysorbate 80; When used alone, the maximum amount of polysorbate 60 shall not ex- whereby the maximum amount of the ceed 0.46 percent of the weight of the additive or additives used does not ex- cake icings and cake fillings. When ceed 0.4 percent of the weight of the used with polysorbate 65 and/or sorbi- finished whipped edible oil topping; ex- tan monostearate, it shall not exceed cept that a combination of the additive 0.46 percent, nor shall the polysorbate with sorbitan monostearate may be 65 exceed 0.32 percent or the sorbitan used in excess of 0.4 percent, provided monostearate exceed 0.7 percent, and that the amount of the additive does no combination of these emulsifiers not exceed 0.77 percent and the amount shall exceed 1 percent of the weight of of sorbitan monostearate does not ex- the cake icing or cake filling. ceed 0.27 percent of the weight of the (6) To impart greater opacity to finished whipped edible oil topping. sugar-type confection coatings where- (2) As an emulsifier in cakes and cake by the maximum amount of the addi- mixes, with or without one or a com- tive does not exceed 0.2 percent of the bination of the following: weight of the finished sugar coating. (i) Polysorbate 65. (7) As an emulsifier in nonstandard- (ii) Sorbitan monostearate. ized dressings whereby the maximum When used alone, the maximum amount of the additive does not exceed amount of polysorbate 60 shall not ex- 0.3 percent of the weight of the finished ceed 0.46 percent of the cake or cake dressings. mix, on a dry-weight basis. When used (8) As an emulsifier, alone or in com- with polysorbate 65 and/or sorbitan bination with polysorbate 80, in monostearate, it shall not exceed 0.46 shortenings and edible oils intended for percent, nor shall the polysorbate 65 use in foods as follows, when standards exceed 0.32 percent or the sorbitan of identity established under section monostearate exceed 0.61 percent, and 401 of the act do not preclude such use: no combination of these emulsifiers (i) It is used alone in an amount not shall exceed 0.66 percent of the cake or to exceed 1 percent of the weight of the cake mix, all calculated on a dry- finished shortening or oil. weight basis. (ii) It is used with polysorbate 80 in (3) As an emulsifier, alone or in com- any combination providing no more bination with sorbitan monostearate, than 1 percent of polysorbate 60 and no

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more than 1 percent of polysorbate 80, (ii) In sugar-based gelatin dessert provided that the total combination mixes in an amount not to exceed 0.5 does not exceed 1 percent of the fin- percent by weight of the mix. ished shortening or oil. (iii) In artificially sweetened gelatin (iii) The 1–percent limitation speci- dessert mixes in an amount not to ex- fied in paragraph (c)(8) (i) and (ii) of ceed 3.6 percent by weight of the mix. this section may be exceeded in premix (iv) In sugar-based pudding mixes in concentrates of shortening or edible oil an amount not to exceed 0.5 percent by if the labeling complies with the re- weight of the mix. quirements of paragraph (d) of this sec- (v) In artificially sweetened pudding tion. mixes in an amount not to exceed 0.5 (9) As an emulsifier in solid-state, ed- percent by weight of the mix. ible vegetable fat-water emulsions in- (16) As an emulsifier in ice cream, tended for use as substitutes for milk frozen custard, fruit sherbet, and non- or cream in beverage coffee, with or standardized frozen desserts when used without one or a combination of the alone or in combination with poly- following: sorbate 65 and/or polysorbate 80, where- (i) Polysorbate 65. by the maximum amount of the addi- (ii) Sorbitan monostearate. tives, alone or in combination, does not exceed 0.1 percent of the finished frozen The maximum amount of the additive dessert. or additives shall not exceed 0.4 per- (d) To assure safe use of the additive, cent by weight of the finished edible in addition to the other information re- vegetable fat-water emulsion. quired by the Act: (10) As a foaming agent in non- (1) The label of the additive and any alcoholic mixes, to be added to alco- intermediate premixes shall bear: holic beverages in the preparation of (i) The name of the additive. mixed alcoholic drinks, at a level not (ii) A statement of the concentration to exceed 4.5 percent by weight of the or strength of the additive in any in- nonalcoholic mix. termediate premixes. (11) As a dough conditioner in yeast- (2) The label or labeling shall bear leavened bakery products in an amount adequate directions to provide a final not to exceed 0.5 percent by weight of product that complies with the limita- the flour used. tions prescribed in paragraph (c) of this (12) As an emulsifier, alone or in section. combination with sorbitan monostea- [42 FR 14491, Mar. 15, 1977, as amended at 43 rate, in the minimum quantity re- FR 2871, Jan. 25, 1978; 45 FR 58836, Sept. 5, quired to accomplish the intended ef- 1980; 46 FR 8466, Jan. 27, 1981; 64 FR 57976, fect, in formulations of white mineral Oct. 28, 1999] oil conforming with § 172.878 and/or petroleum wax conforming with § 172.886 § 172.838 Polysorbate 65. for use as protective coatings on raw The food additive polysorbate 65 fruits and vegetables. (polyoxyethylene (20) sorbitan (13) As a dispersing agent in artifi- tristearate), which is a mixture of cially sweetened gelatin desserts and in polyoxyethylene ethers of mixed ste- artificially sweetened gelatin dessert aric acid esters of sorbitol anhydrides mixes, whereby the amount of the addi- and related compounds, may be safely tive does not exceed 0.5 percent on a used in food in accordance with the fol- dry-weight basis. lowing prescribed conditions: (14) As an emulsifier in chocolate fla- (a) The food additive is manufactured vored syrups, whereby the maximum by reacting stearic acid (usually con- amount of the additive does not exceed taining associated fatty acids, chiefly 0.05 percent in the finished product. palmitic) with sorbitol to yield a prod- (15) As a surfactant and wetting uct with a maximum acid number of 15 agent for natural and artificial colors and a maximum water content of 0.2 in food as follows: percent, which is then reacted with (i) In powdered soft drink mixes in an ethylene oxide. amount not to exceed 4.5 percent by (b) The food additive meets the fol- weight of the mix. lowing specifications:

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Saponification number 88–98. (ii) Polysorbate 60. Acid number 0–2. Hydroxyl number 44–60. When used alone, the maximum Oxyethylene content 46 percent–50 percent. amount of polysorbate 65 shall not exceed 0.32 percent of the weight of the (c) The additive is used, or intended cake icing or cake filling. When used for use, as follows: with sorbitan monostearate and/or (1) As an emulsifier in ice cream, fro- polysorbate 60, it shall not exceed 0.32 zen custard, ice milk, fruit sherbet and percent, nor shall the sorbitan mono- nonstandardized frozen desserts when stearate exceed 0.7 percent or the poly- used alone or in combination with sorbate 60 exceed 0.46 percent, and no polysorbate 80, whereby the maximum combination of these emulsifiers shall amount of the additives, alone or in exceed 1 percent of the weight of the combination, does not exceed 0.1 per- cake icing or cake filling. cent of the finished frozen dessert. (d) To assure safe use of the additive, (2) As an emulsifier in cakes and cake in addition to the other information re- mixes, with or without one or a com- quired by the Act: bination of the following: (1) The label of the additive and any (i) Sorbitan monostearate. intermediate premixes shall bear: (ii) Polysorbate 60. (i) The name of the additive. When used alone, the maximum (ii) A statement of the concentration amount of polysorbate 65 shall not ex- or strength of the additive in any in- ceed 0.32 percent of the cake or cake termediate premixes. mix, on a dry-weight basis. When used (2) The label or labeling shall bear with sorbitan monostearate and/or adequate directions to provide a final polysorbate 60, it shall not exceed 0.32 product that complies with the limita- percent, nor shall the sorbitan mono- tions prescribed in paragraph (c) of this stearate exceed 0.61 percent or the section. polysorbate 60 exceed 0.46 percent, and [42 FR 14491, Mar. 15, 1977, as amended at 43 no combination of these emulsifiers FR 2871, Jan. 20, 1978] shall exceed 0.66 percent of the cake or cake mix, all calculated on a dry- § 172.840 Polysorbate 80. weight basis. The food additive polysorbate 80 (3) As an emulsifier in whipped edible (polyoxyethylene (20) sorbitan oil topping with or without one or a monooleate), which is a mixture of combination of the following: polyoxyethylene ethers of mixed par- (i) Sorbitan monostearate; tial oleic acid esters of sorbitol anhy- (ii) Polysorbate 60; drides and related compounds, may be (iii) Polysorbate 80; safely used in food in accordance with whereby the maximum amount of the the following prescribed conditions: additive or additives used does not ex- (a) The food additive is manufactured ceed 0.4 percent of the weight of the by reacting oleic acid (usually con- finished whipped edible oil topping. taining associated fatty acids) with (4) As an emulsifier in solid-state, ed- sorbitol to yield a product with a max- ible vegetable fat-water emulsions in- imum acid number of 7.5 and a max- tended for use as substitutes for milk imum water content of 0.5 percent, or cream in beverage coffee, with or which is then reacted with ethylene without one or a combination of the oxide. following: (b) The food additive meets the fol- (i) Sorbitan monostearate. lowing specifications: (ii) Polysorbate 60. Saponification number 45–55. The maximum amount of the additive Acid number 0–2. or additives shall not exceed 0.4 per- Hydroxyl number 65–80. cent by weight of the finished edible Oxyethylene content 65 percent–69.5 percent. vegetable fat-water emulsion. (c) The additive is used or intended (5) As an emulsifier in cake icings for use as follows: and cake fillings, with or without one (1) An emulsifier in ice cream, frozen or a combination of the following: custard, ice milk, fruit sherbet, and (i) Sorbitan monostearate. nonstandardized frozen desserts, when

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used alone or in combination with of identity established under section polysorbate 65 whereby the maximum 401 of the act do not preclude such use: amount of the additives, alone or in (i) It is used alone in an amount not combination, does not exceed 0.1 per- to exceed 1 percent of the weight of the cent of the finished frozen dessert. finished shortening or oil. (2) In yeast-defoamer formulations (ii) It is used with polysorbate 60 in whereby the maximum amount of the any combination providing no more additive does not exceed 4 percent of than 1 percent of polysorbate 80 and no the finished yeast defoamer and the more than 1 percent of polysorbate 60, maximum amount of the additive in provided that the total combination the yeast from such use does not ex- does not exceed 1 percent of the fin- ceed 4 parts per million. ished shortening or oil. (3) As a solubilizing and dispersing (iii) The 1–percent limitation speci- agent in pickles and pickle products, fied in paragraph (c)(8) (i) and (ii) of whereby the maximum amount of the this section may be exceeded in premix additive does not exceed 500 parts per concentrates of shortening or edible oil million. if the labeling complies with the re- (4) As a solubilizing and dispersing quirements of paragraph (d) of this sec- agent in: tion. (i) Vitamin-mineral preparations (9) As an emulsifier in whipped edible containing calcium caseinate in the ab- oil topping with or without one or a sence of fat-soluble vitamins, whereby combination of the following: the maximum intake of polysorbate 80 (i) Sorbitan monostearate; shall not exceed 175 milligrams from (ii) Polysorbate 60; the recommended daily dose of the (iii) Polysorbate 65; preparations. (ii) Fat-soluble vitamins in vitamin whereby the maximum amount of the and vitamin-mineral preparations con- additive or additives used does not ex- taining no calcium caseinate, whereby ceed 0.4 percent of the weight of the the maximum intake of polysorbate 80 finished whipped edible oil topping. shall not exceed 300 milligrams from (10) It is used as a wetting agent in the recommended daily dose of the scald water for poultry defeathering, preparations. followed by potable water rinse. The (iii) In vitamin-mineral preparations concentration of the additive in the containing both calcium caseinate and scald water does not exceed 0.0175 per- fat-soluble vitamins, whereby the max- cent. imum intake of polysorbate 80 shall (11) As a dispersing agent in gelatin not exceed 475 milligrams from the rec- desserts and in gelatin dessert mixes, ommended daily dose of the prepara- whereby the amount of the additive tions. does not exceed 0.082 percent on a dry- (5) As a surfactant in the production weight basis. of coarse crystal sodium chloride (12) As an adjuvant added to herbi- whereby the maximum amount of the cide use and plant-growth regulator additive in the finished sodium chlo- use dilutions by a grower or applicator ride does not exceed 10 parts per mil- prior to application of such dilutions to lion. the growing crop. Residues resulting (6) In special dietary foods, as an from such use are exempt from the re- emulsifier for edible fats and oils, with quirement of a tolerance. When so used directions for use which provide for the or intended for use, the additive shall ingestion of not more than 360 milli- be exempt from the requirements of grams of polysorbate 80 per day. paragraph (d)(1) of this section. (7) As a solubilizing and dispersing (13) As a defoaming agent in the prep- agent for dill oil in canned spiced green aration of the creaming mixture for beans, not to exceed 30 parts per mil- cottage cheese and lowfat cottage lion. cheese, as identified in §§ 133.128 and (8) As an emulsifier, alone or in com- 133.131 of this chapter, respectively, bination with polysorbate 60, in whereby the amount of the additive shortenings and edible oils intended for does not exceed .008 percent by weight use in foods as follows, when standards of the finished products.

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(14) As a surfactant and wetting (c) Polydextrose is used in accord- agent for natural and artificial colors ance with current good manufacturing for use in barbecue sauce where the practices as a bulking agent, formula- level of the additive does not exceed tion aid, humectant, and texturizer in 0.005 percent by weight of the barbecue the following foods when standards of sauce. identity established under section 401 (d) To assure safe use of the additive, of the act do not preclude such use: in addition to the other information re- (1) Baked goods and baking mixes (required by the Act: stricted to fruit, custard, and pudding- (1) The label of the additive and any filled pies, cakes, cookies, and similar intermediate premixes shall bear: baked products); (i) The name of the additive. (2) Chewing gum; (ii) A statement of the concentration (3) Confections and frostings; or strength of the additive in any in- (4) Dressings for salads; termediate premixes. (5) Film coatings on single and mul- (2) The label or labeling shall bear tiple vitamin and mineral supplement adequate directions to provide a final tablets; product that complies with the limita- (6) Frozen dairy desserts and mixes; tions prescribed in paragraph (c) of this (7) Fruit and water ices; section. (8) Fruit spreads; (9) Gelatins, puddings and fillings; [42 FR 14491, Mar. 15, 1977, as amended at 43 (10) Hard and soft candy; FR 2871, Jan. 20, 1978; 45 FR 58835, Sept. 5, 1980; 46 FR 8466, Jan. 27, 1981] (11) Peanut spread; (12) Sweet sauces, toppings, and syr- § 172.841 Polydextrose. ups; Polydextrose as identified in this sec- (13) Tablespreads. (d) If the food containing the additive tion may be safely used in food in ac- purports to be or is represented for spe- cordance with the following prescribed cial dietary uses, it shall be labeled in conditions: (a)(1) Polydextrose (CAS Reg. No. compliance with part 105 of this chap- 68424–04–4) is a partially metabolizable ter. (e) The label and labeling of food a water-soluble polymer prepared by the single serving of which would be ex- condensation of a melt which consists pected to exceed 15 grams of the addi- either of approximately 89 percent D- tive shall bear the statement: ‘‘Sen- glucose, 10 percent sorbitol, and 1 per- sitive individuals may experience a cent citric acid or of approximately 90 laxative effect from excessive con- percent D-glucose, 10 percent sorbitol, sumption of this product’’. and 0.1 percent phosphoric acid, on a weight basis. [46 FR 30081, June 5, 1981, as amended at 59 (2) Polydextrose may be partially FR 37421, July 22, 1994; 60 FR 54425, Oct. 24, neutralized with potassium hydroxide, 1995; 61 FR 14480, Apr. 2, 1996; 62 FR 30985, or partially reduced by transition June 6, 1997; 63 FR 57597, Oct. 28, 1998; 65 FR metal catalytic hydrogenation in aque- 64605, Oct. 30, 2000; 65 FR 79719, Dec. 20, 2000] ous solution. § 172.842 Sorbitan monostearate. (b) The additive meets the specifications of the ‘‘Food Chemicals Codex,’’ The food additive sorbitan monostea- 4th ed. (1996), pp. 297–300, which is in- rate, which is a mixture of partial ste- corporated by reference in accordance aric and palmitic acid esters of sorbitol with 5 U.S.C. 552(a) and 1 CFR part 51. anhydrides, may be safely used in or on Copies are available from the National food in accordance with the following Academy Press, 2101 Constitution Ave. prescribed conditions: NW., Washington, DC 20418, or may be (a) The food additive is manufactured examined at the Center for Food Safety by reacting stearic acid (usually con- and Applied Nutrition’s Library, Food taining associated fatty acids, chiefly and Drug Administration, 5100 Paint palmitic) with sorbitol to yield essen- Branch Pkwy., College Park, MD 20740, tially a mixture of esters. or at the Office of the Federal Register, (b) The food additive meets the fol- 800 North Capitol St. NW., suite 700, lowing specifications: Washington, DC. Saponification number, 147–157

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Acid number, 5–10 nonstandardized confectionery coating Hydroxyl number, 235–260 or standardized cacao product. (c) It is used or intended for use, (4) As an emulsifier in cake icings alone or in combination with poly- and cake fillings, with or without one sorbate 60 as follows: or a combination of the following: (1) As an emulsifier in whipped edible (i) Polysorbate 65. oil topping with or without one or a (ii) Polysorbate 60. combination of the following: (i) Polysorbate 60; When used alone, the maximum (ii) Polysorbate 65; amount of sorbitan monostearate shall (iii) Polysorbate 80; not exceed 0.7 percent of the weight of the cake icing or cake filling. When whereby the maximum amount of the used with polysorbate 65 and/or poly- additive or additives used does not exceed 0.4 percent of the weight of the sorbate 60, it shall not exceed 0.7 per- finished whipped edible oil topping; ex- cent, nor shall the polysorbate 65 except that a combination of the additive ceed 0.32 percent or the polysorbate 60 with polysorbate 60 may be used in ex- exceed 0.46 percent, and no combina- cess of 0.4 percent: Provided, That the tion of these emulsifiers shall exceed 1 amount of the additive does not exceed percent of the weight of the cake icing 0.27 percent and the amount of poly- or cake filling. sorbate 60 does not exceed 0.77 percent (5) As an emulsifier in solid-state, ed- of the weight of the finished whipped ible vegetable fat-water emulsions in- edible oil topping. tended for use as substitutes for milk (2) As an emulsifier in cakes and cake or cream in beverage coffee, with or mixes, with or without one or a com- without one or a combination of the bination of the following: following: (i) Polysorbate 65. (i) Polysorbate 60. (ii) Polysorbate 60. (ii) Polysorbate 65. When used alone, the maximum The maximum amount of the additive amount of sorbitan monostearate shall or additives shall not exceed 0.4 per- not exceed 0.61 percent of the cake or cent by weight of the finished edible cake mix, on a dry-weight basis. When used with polysorbate 65 and/or poly- vegetable fat-water emulsion. sorbate 60, it shall not exceed 0.61 per- (6) It is used alone as a rehydration cent, nor shall the polysorbate 65 ex- aid in the production of active dry ceed 0.32 percent or the polysorbate 60 yeast in an amount not to exceed 1 per- exceed 0.46 percent, and no combina- cent by weight of the dry yeast. tion of the emulsifiers shall exceed 0.66 (7) As an emulsifier, alone or in com- percent of the weight of the cake or bination with polysorbate 60, in the cake mix, calculated on a dry-weight minimum quantity required to accom- basis. plish the intended effect, in formula- (3) As an emulsifier, alone or in com- tions of white mineral oil conforming bination with polysorbate 60 in non- with § 172.878 and/or petroleum wax standardized confectionery coatings conforming with § 172.886 for use as pro- and standardized cacao products speci- tective coatings on raw fruits and vege- fied in §§ 163.123, 163.130, 163.135, 163.140, tables. 163.145, and 163.150 of this chapter, as (d) To assure safe use of the additive, follows: in addition to the other information re- (i) It is used alone in an amount not quired by the Act: to exceed 1 percent of the weight of the (1) The label of the additive and any finished nonstandardized confectionery intermediate premixes shall bear: coating or standardized cacao product. (ii) It is used with polysorbate 60 in (i) The name of the additive. any combination of up to 1 percent sor- (ii) A statement of the concentration bitan monostearate and up to 0.5 per- or strength of the additive in any in- cent polysorbate 60 provided that the termediate premixes. total combination does not exceed 1 (2) The label or labeling shall bear percent of the weight of the finished adequate directions to provide a final

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product that complies with the limita- that complies with the limitations pre- tions prescribed in paragraph (c) of this scribed in paragraph (c) of this section. section. § 172.846 Sodium stearoyl lactylate. [42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978] The food additive sodium stearoyl lactylate (CAS Reg. No. 25–383–997) may § 172.844 Calcium stearoyl-2-lactylate. be safely used in food in accordance The food additive calcium stearoyl-2- with the following prescribed condi- lactylate may be safely used in or on tions: food in accordance with the following (a) The additive, which is a mixture prescribed conditions: of sodium salts of stearoyl lactylic (a) The additive, which is a mixture acids and minor proportions of sodium of calcium salts of stearoyl lactylic salts of related acids, is manufactured acids and minor proportions of other by the reaction of stearic acid and lac- calcium salts of related acids, is manu- tic acid and conversion to the sodium factured by the reaction of stearic acid salts. and lactic acid and conversion to the (b) The additive meets the specifica- calcium salts. tions of the ‘‘Food Chemicals Codex,’’ (b) The additive meets the following 3d Ed. (1981), pp. 300–301, which is incor- specifications: porated by reference. Copies may be obtained from the National Academy Acid number, 50–86. Press, 2101 Constitution Ave. NW., Calcium content, 4.2–5.2 percent. Washington, DC 20418, or may be exam- Lactic acid content, 32–38 percent. ined at the Office of the Federal Reg- Ester number, 125–164. ister, 800 North Capitol Street, NW., (c) It is used or intended for use as suite 700, Washington, DC 20408. follows: (c) It is used or intended for use as (1) As a dough conditioner in yeast- follows when standards of identity es- leavened bakery products and prepared tablished under section 401 of the Act mixes for yeast-leavened bakery prod- do not preclude such use: ucts in an amount not to exceed 0.5 (1) As a dough strengthener, emulsi- part for each 100 parts by weight of fier, or processing aid in baked prod- flour used. ucts, pancakes, and waffles, in an (2) As a whipping agent in: amount not to exceed 0.5 part for each (i) Liquid and frozen egg white at a 100 parts by weight of flour used. level not to exceed 0.05 percent. (2) As a surface-active agent, emulsi- (ii) Dried egg white at a level not to fier, or stabilizer in icings, fillings, exceed 0.5 percent. puddings, and toppings, at a level not (iii) Whipped vegetable oil topping at to exceed 0.2 percent by weight of the a level not to exceed 0.3 percent of the finished food. weight of the finished whipped vege- (3) As an emulsifier or stabilizer in table oil topping. liquid and solid edible fat-water emul- (3) As a conditioning agent in dehy- sions intended for use as substitutes drated potatoes in an amount not to for milk or cream in beverage coffee, at exceed 0.5 percent by weight thereof. a level not to exceed 0.3 percent by (d) To assure safe use of the additive: weight of the finished edible fat-water (1) The label and labeling of the food emulsion. additive and any intermediate premix (4) As a formulation aid, processing prepared therefrom shall bear, in addi- aid, or surface-active agent in dehy- tion to the other information required drated potatoes, in an amount not to by the act, the following: exceed 0.5 percent of the dry weight of (i) The name of the additive. the food. (ii) A statement of the concentration (5) As an emulsifier, stabilizer, or or strength of the additive in any in- texturizer in snack dips, at a level not termediate premixes. to exceed 0.2 percent by weight of the (2) The label or labeling of the food finished product. additive shall also bear adequate direc- (6) As an emulsifier, stabilizer, or tions of use to provide a finished food texturizer in cheese substitutes and

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imitations and cheese product sub- § 172.850 Lactylated fatty acid esters stitutes and imitations, at a level not of glycerol and propylene glycol. to exceed 0.2 percent by weight of the The food additive lactylated fatty finished food. acid esters of glycerol and propylene (7) As an emulsifier, stabilizer, or glycol may be safely used in food in ac- texturizer in sauces or gravies, and the cordance with the following prescribed products containing the same, in an conditions: amount not to exceed 0.25 percent by (a) The additive is a mixture of esters weight of the finished food. produced by the lactylation of a prod- (8) In prepared mixes for each of the uct obtained by reacting edible fats or foods listed in paragraphs (c) (1) oils with propylene glycol. through (7) of this section, provided the (b) The additive meets the following additive is used only as specified in specifications: Water insoluble com- each of those paragraphs. bined lactic acid, 14–18 percent; and (9) As an emulsifier, stabilizer, or acid number, 12 maximum. texturizer in cream liqueur drinks, at a (c) It is used in amounts not in excess level not to exceed 0.5 percent by of that reasonably required to produce weight of the finished product. the intended physical effect as an emulsifier, plasticizer, or surface-ac- [45 FR 51767, Aug. 5, 1980, as amended at 49 tive agent in food. FR 10105, Mar. 19, 1984; 50 FR 49536, Dec. 3, 1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333, Jan. § 172.852 Glyceryl-lacto esters of fatty 27, 1986; 65 FR 60859, Oct. 13, 2000] acids. § 172.848 Lactylic esters of fatty acids. Glyceryl-lacto esters of fatty acids (the lactic acid esters of mono- and Lactylic esters of fatty acids may be diglycerides) may be safely used in safely used in food in accordance with food in accordance with the following the following prescribed conditions: prescribed conditions: (a) They are prepared from lactic (a) They are manufactured from glyc- acid and fatty acids meeting the re- erin, lactic acid, and fatty acids con- quirements of § 172.860(b) and/or oleic forming with § 172.860 and/or oleic acid acid derived from tall oil fatty acids derived from tall oil fatty acids con- meeting the requirements of § 172.862. forming with § 172.862 and/or edible fats (b) They are used as emulsifiers, plas- and oils. ticizers, or surface-active agents in the (b) They are used in amounts not in following foods, when standards of excess of those reasonably required to identity do not preclude their use: accomplish their intended physical or technical effect as emulsifiers and plas- Foods Limitations ticizers in food. Bakery mixes ...... Baked products ...... § 172.854 Polyglycerol esters of fatty Cake icings, fillings, and toppings acids. Dehydrated fruits and vegetables Polyglycerol esters of fatty acids, up Dehydrated fruit and vegetable juices. to and including the decaglycerol Edible vegetable fat-water emul- As substitutes for milk or esters, may be safely used in food in ac- sions. cream in beverage cof- cordance with the following prescribed fee. conditions: Frozen desserts ...... (a) They are prepared from corn oil, Liquid shortening ...... For household use. Pancake mixes ...... cottonseed oil, lard, palm oil from Precooked instant rice ...... fruit, peanut oil, safflower oil, sesame Pudding mixes ...... oil, soybean oil, and tallow and the fatty acids derived from these sub- (c) They are used in an amount not stances (hydrogenated and nonhydro- greater than required to produce the genated) meeting the requirements of intended physical or technical effect, § 172.860(b) and/or oleic acid derived and they may be used with shortening from tall oil fatty acids meeting the and edible fats and oils when such are requirements of § 172.862. required in the foods identified in para- (b) They are used as emulsifiers in graph (b) of this section. food, in amounts not greater than that

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required to produce the intended phys- Office of the Federal Register, 800 ical or technical effect. North Capitol Street, NW., suite 700, (c) Polyglycerol esters of a mixture Washington, DC 20408), and the addi- of stearic, oleic, and coconut fatty tional specification that it shall have acids are used as a cloud inhibitor in up to 85 percent of the carboxylic acid vegetable and salad oils when use is groups esterified with the remaining not precluded by standards of identity. groups either free or neutralized. The fatty acids used in the production (b) The additive is used or intended of the polyglycerol esters meet the re- for use in the following foods as defined quirements of § 172.860(b), and the in § 170.3(n) of this chapter, when stand- polyglycerol esters are used at a level ards of identity established under sec- not in excess of the amount required to tion 401 of the act do not preclude such perform its cloud-inhibiting effect. use: Oleic acid derived from tall oil fatty (1) As a stabilizer in frozen dairy des- acids conforming with § 172.862 may be serts, in fruit and water ices, and in used as a substitute for or together confections and frostings at a level not with the oleic acid permitted by this to exceed 0.5 percent by weight of the paragraph. finished product. (d) Polyglycerol esters of butter oil (2) As an emulsifier, flavoring adju- fatty acids are used as emulsifiers in vant, stabilizer, or thickener in baked combination with other approved emul- goods at a level not to exceed 0.5 per- sifiers in dry, whipped topping base. cent by weight of the finished product. The fatty acids used in the production (3) As an emulsifier, stabilizer, or of the polyglycerol esters meet the re- thickener in cheeses at a level not to quirements of § 172.860(b), and the exceed 0.9 percent by weight of the fin- polyglycerol esters are used at a level ished product. not in excess of the amount required to (4) As an emulsifier, stabilizer, or perform their emulsifying effect. thickener in fats and oils at a level not to exceed 1.1 percent by weight of the § 172.856 Propylene glycol mono- and finished product. diesters of fats and fatty acids. (5) As an emulsifier, stabilizer, or Propylene glycol mono- and diesters thickener in gelatins and puddings at a of fats and fatty acids may be safely level not to exceed 0.6 percent by used in food, subject to the following weight of the finished product. prescribed conditions: (6) As a stabilizer or thickener in gra- (a) They are produced from edible vies and in sweet sauces at a level not fats and/or fatty acids in compliance to exceed 0.5 percent by weight of the with § 172.860 and/or oleic acid derived finished product. from tall oil fatty acids in compliance (7) As a stabilizer in jams and jellies with § 172.862. at a level not to exceed 0.4 percent by (b) They are used in food in amounts weight of the finished product. not in excess of that reasonably re- (8) As an emulsifier, stabilizer, or quired to produce their intended effect. thickener in condiments and relishes at a level not to exceed 0.6 percent by § 172.858 Propylene glycol alginate. weight of the finished product. The food additive propylene glycol (9) As a flavoring adjunct or adjuvant alginate (CAS Reg. No. 9005–37–2) may in seasonings and flavors at a level not be used as an emulsifier, flavoring ad- to exceed 1.7 percent by weight of the juvant, formulation aid, stabilizer, sur- finished product. factant, or thickener in foods in ac- (10) As an emulsifier, flavoring adju- cordance with the following prescribed vant, formulation aid, stabilizer or conditions: thickener, or surface active agent in (a) The additive meets the specifica- other foods, where applicable, at a tions of the Food Chemicals Codex, 3d level not to exceed 0.3 percent by Ed. (1981), p. 256, which is incorporated weight of the finished product. by reference (copies are available from (c) To ensure safe use of the additive, the National Academy Press, 2101 Con- the label of the food additive container stitution Ave. NW., Washington, DC shall bear, in addition to the other in- 20418, or available for inspection at the formation required by the act:

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(1) The name of the additive, ‘‘pro- 200), Food and Drug Administration, pylene glycol alginate’’ or ‘‘propylene 5100 Paint Branch Pkwy., College Park, glycol ester of alginic acid’’. MD 20740, or available for inspection at (2) Adequate directions for use. the Office of the Federal Register, 800 [47 FR 29950, July 9, 1982] North Capitol Street, NW., suite 700, Washington, DC 20408. § 172.859 Sucrose fatty acid esters. (6) Arsenic is not more than 3 parts Sucrose fatty acid esters identified in per million. this section may be safely used in ac- (7) Total heavy metal content (as Pb) cordance with the following prescribed is not more than 50 parts per million. conditions: (8) Lead is not more than 10 parts per (a) Sucrose fatty acid esters are the million. mono-, di-, and tri-esters of sucrose (9) The total content of methyl ethyl with fatty acids and are derived from ketone or of methanol shall not be sucrose and edible tallow or hydro- more than 10 parts per million as deter- genated edible tallow or edible vege- mined by a method titled ‘‘Methyl table oils. The only solvents which Ethyl Ketone Test; Methyl Alcohol may be used in the preparation of su- Test,’’ which is incorporated by ref- crose fatty acid esters are those gen- erence. Copies are available from the erally recognized as safe in food or reg- Center for Food Safety and Applied Nu- ulated for such use by an appropriate trition (HFS–200), Food and Drug Ad- section in this part. Ethyl acetate or ministration, 5100 Paint Branch Pkwy., methyl ethyl ketone or dimethyl sulf- College Park, MD 20740, or available for oxide and isobutyl alcohol (2-methyl-1- inspection at the Office of the Federal propanol) may be used in the prepara- Register, 800 North Capitol Street, tion of sucrose fatty acid esters. NW., suite 700, Washington, DC 20408. (b) Sucrose fatty acid esters meet the (10) The total dimethyl sulfoxide con- following specifications: tent is not more than 2 parts per mil- (1) The total content of mono-, di-, lion as determined by a method enti- and tri-esters is not less than 80 percent as determined by a method title tled ‘‘Determination of Dimethyl Sulf- ‘‘Sucrose Fatty Acid Esters, Method of oxide,’’ which is incorporated by ref- Assay,’’ which is incorporated by reference. Copies are available from the erence. Copies are available from the Center for Food Safety and Applied Nu- Center for Food Safety and Applied Nu- trition (HFS–200), Food and Drug Ad- trition (HFS–200), Food and Drug Ad- ministration, 5100 Paint Branch Pkwy., ministration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for College Park, MD 20740, or available for inspection at the Office of the Federal inspection at the Office of the Federal Register, 800 North Capitol Street, Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. NW., suite 700, Washington, DC 20408. (11) The total isobuytl alcohol (2- (2) The free sucrose content is not methyl-1-propanol) content is not more more than 5 percent as determined by than 10 parts per million as determined Test S.2 in the method titled ‘‘Sucrose by a method entitled ‘‘Determination Fatty Acid Esters, Method of Assay,’’ of Isobutyl Alcohol,’’ which is incor- which is incorporated by reference. The porated by reference. Copies are avail- availability of this incorporation by able from the Center for Food Safety reference is given in paragraph (b)(1) of and Applied Nutrition (HFS–200), Food this section. and Drug Administration, 5100 Paint (3) The acid value is not more than 6. Branch Pkwy., College Park, MD 20740, (4) The residue on ignition (sulfated or available for inspection at the Office ash) is not more than 2 percent. of the Federal Register, 800 North Cap- (5) The total ethyl acetate content is itol Street, NW., suite 700, Washington, not more than 350 parts per million as DC 20408. determined by a method titled ‘‘Deter- (c) Sucrose fatty acid esters may be mination of Ethyl Acetate,’’ which is used as follows when standards of iden- incorporated by reference. Copies are tity established under section 401 of available from the Center for Food the Federal Food, Drug, and Cosmetic Safety and Applied Nutrition (HFS– Act do not preclude such use:

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(1) As emulsifiers as defined in (2) It is free of chick-edema factor: § 170.3(o)(8) of this chapter, or as stabi- (i) As evidenced during the bioassay lizers as defined in § 170.3(o)(28) of this method for determining the chick- chapter, in baked goods and baking edema factor as prescribed in para- mixes as defined in § 170.3(n)(1) of this graph (c)(2) of this section; or chapter, in chewing gum as defined in (ii) As evidenced by the absence of § 170.3(n)(6) of this chapter, in coffee chromatographic peaks with a reten- and tea beverages with added dairy in- tion time relative to aldrin (RA) be- gredients and/or dairy product ana- tween 10 and 25, using the gas logues, in confections and frostings as chromatographic-electron capture defined in § 170.3(n)(9) of this chapter, method prescribed in paragraph (c)(3) in dairy product analogues as defined of this section. If chromatographic in § 170.3(n)(10) of this chapter, in frozen peaks are found with RA values be- dairy desserts and mixes as defined in tween 10 and 25, the food additive shall § 170.3(n)(20) of this chapter, and in meet the requirements of the bioassay whipped milk products. method prescribed in paragraph (c)(2) (2) As texturizers as defined in of this section for determining chick- § 170.3(o)(32) of this chapter in biscuit edema factor. mixes, in chewing gum as defined in (c) For the purposes of this section: § 170.3(n)(6) of this chapter, in confections and frostings as defined in (1) Unsaponifiable matter shall be de- § 170.3(n)(9) of this chapter, and in termined by the method described in surimi-based fabricated seafood prod- the 13th Ed. (1980) of the ‘‘Official ucts. Methods of Analysis of the Association (3) As components of protective coat- of Official Analytical Chemists,’’ which ings applied to fresh apples, avocados, is incorporated by reference. Copies are bananas, banana plantains, limes, mel- available from the Association of Offi- ons (honeydew and cantaloupe), pa- cial Analytical Chemists International, paya, peaches, pears, pineapples, and 481 North Frederick Ave., suite 500, plums to retard ripening and spoiling. Gaithersburg, MD 20877–2504, or avail- (d) Sucrose fatty acid esters are used able for inspection at the Office of the in accordance with current good manu- Federal Register, 800 North Capitol facturing practice and in an amount Street, NW., suite 700, Washington, DC not to exceed that reasonably required 20408. to accomplish the intended effect. (2) Chick-edema factor shall be determined by the bioassay method de- [47 FR 55475, Dec. 10, 1982, as amended at 48 scribed in ‘‘Official Methods of Anal- FR 38226, Aug. 23, 1983; 52 FR 10883, Apr. 6, 1987; 53 FR 22294, 22297, June 15, 1988; 54 FR ysis of the Association of Official Ana- 24897, June 12, 1989; 60 FR 44756, Aug. 29, 1995] lytical Chemists,’’ 13th Ed. (1980), sections 28.127–28.130, which is incor- § 172.860 Fatty acids. porated by reference. Copies may be The food additive fatty acids may be obtained from the Association of Offi- safely used in food and in the manufac- cial Analytical Chemists International, ture of food components in accordance 481 North Frederick Ave., suite 500, with the following prescribed condi- Gaithersburg, MD 20877–2504, or may be tions: examined at the Office of the Federal (a) The food additive consists of one Register, 800 North Capitol Street, or any mixture of the following NW., suite 700, Washington, DC 20408. straight-chain monobasic carboxylic (3) The gas chromatographic-electron acids and their associated fatty acids capture method for testing fatty acids manufactured from fats and oils de- for chick-edema shall be the method rived from edible sources: Capric acid, described in the ‘‘Journal of the Asso- caprylic acid, lauric acid, myristic ciation of Official Analytical Chem- acid, oleic acid, palmitic acid, and ste- ists,’’ Volume 50 (No. 1), pages 216–218 aric acid. (1967), or the modified method using a (b) The food additive meets the fol- sulfuric acid clean-up procedure, as de- lowing specifications: scribed in the ‘‘Journal of the Associa- (1) Unsaponifiable matter does not tion of the Offical Analytical Chem- exceed 2 percent. ists,’’ Volume 51 (No. 2), pages 489–490

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(1968), which are incorporated by ref- unless permitted by the standard of erence. See paragraph (c)(2) of this sec- identity. tion for availability of these ref- (d) The ingredient is used in accord- erences. ance with current good manufacturing (d) It is used or intended for use as practice and in an amount not to ex- follows: ceed that reasonably required to ac- (1) In foods as a lubricant, binder, complish the intended effect. and as a defoaming agent in accordance with good manufacturing practice. [56 FR 66970, Dec. 27, 1991; 57 FR 2814, Jan. 23, 1992] (2) As a component in the manufacture of other food-grade additives. § 172.862 Oleic acid derived from tall (e) To assure safe use of the additive, oil fatty acids. the label and labeling of the additive The food additive oleic acid derived and any premix thereof shall bear, in from tall oil fatty acids may be safely addition to the other information re- used in food and as a component in the quired by the act, the following: manufacture of food-grade additives in (1) The common or usual name of the accordance with the following pre- acid or acids contained therein. scribed conditions: (2) The words ‘‘food grade,’’ in jux- (a) The additive consists of purified taposition with and equally as promi- oleic acid separated from refined tall nent as the name of the acid. oil fatty acids. [42 FR 14491, Mar. 15, 1977, as amended at 47 (b) The additive meets the following FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, specifications: 1984; 54 FR 24897, June 12, 1989] (1) Specifications for oleic acid prescribed in the ‘‘Food Chemicals § 172.861 Cocoa butter substitute from coconut oil, palm kernel oil, or both Codex.’’ 3d Ed. (1981), pp. 207–208, which oils. is incorporated by reference, except that titer (solidification point) shall The food additive, cocoa butter sub- not exceed 13.5 °C and unsaponifiable stitute from coconut oil, palm kernel matter shall not exceed 0.5 percent. oil, or both oils, may be safely used in Copies of the material incorporated by food in accordance with the following reference may be obtained from the conditions: National Academy Press, 2101 Constitu- (a) Cocoa butter substitute from co- tion Ave. NW., Washington, DC 20418, conut oil, palm kernel oil (CAS Reg. or may be examined at the Office of the No. 85665–33–4), or both oils is a mixture Federal Register, 800 North Capitol of triglycerides. It is manufactured by Street, NW., suite 700, Washington, DC esterification of glycerol with food- 20408. grade fatty acids (complying with (2) The resin acid content does not § 172.860) derived from edible coconut exceed 0.01 as determined by ASTM oil, edible palm kernel oil, or both oils. method D1240–82, ‘‘Standard Test Meth- (b) The ingredient meets the fol- od for Rosin Acids in Fatty Acids,’’ lowing specifications: which is incorporated by reference. Acid number: Not to exceed 0.5. Copies may be obtained from the Amer- Saponification number: 220 to 260. ican Society for Testing Materials, 1916 Iodine number: Not to exceed 3. Race St., Philadelphia, PA 19103, or Melting range: 30 to 44 °C. may be examined at the Office of the (c) The ingredient is used or intended Federal Register, 800 North Capitol for use as follows: Street, NW., suite 700, Washington, DC (1) As coating material for sugar, 20408. table salt, vitamins, citric acid, suc- (3) The requirements for absence of cinic acid, and spices; and chick-edema factor as prescribed in (2) In compound coatings, cocoa § 172.860. creams, cocoa-based sweets, toffees, (c) It is used or intended for use as caramel masses, and chewing sweets as follows: defined in § 170.3 (n)(9) and (n)(38) of (1) In foods as a lubricant, binder, this chapter, except that the ingredient and defoaming agent in accordance may not be used in a standardized food with good manufacturing practice.

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(2) As a component in the manufac- trialkylaluminum with purified ethyl- ture of other food-grade additives. ene (minimum 99 percent by volume (d) To assure safe use of the additive, C2H4), and utilizing the hydrocarbon the label and labeling of the additive solvent as defined in paragraph (b) of and any premix thereof shall bear, in this section, such that: addition to the other information re- (i) Hexyl, octyl, decyl, lauryl, and quired by the Act, the following: myristyl alcohols contain not less than (1) The common or usual name of the 99 percent of total alcohols and not less acid. than 96 percent of straight chain alco- (2) The words ‘‘food grade’’ in jux- hols. Any nonalcoholic impurities are taposition with and equally as promi- primarily paraffins. nent as the name of the acid. (ii) Cetyl and stearyl alcohols con- [42 FR 14491, Mar. 15, 1977, as amended at 49 tain not less than 98 percent of total FR 10105, Mar. 19, 1984] alcohols and not less than 94 percent of straight chain alcohols. Any non- § 172.863 Salts of fatty acids. alcoholic impurities are primarily The food additive salts of fatty acids paraffins. may be safely used in food and in the (iii) The synthetic fatty alcohols con- manufacture of food components in ac- tain no more than 0.1 weight percent of cordance with the following prescribed total diols as determined by a method conditions: available upon request from the Com- (a) The additive consists of one or missioner of Food and Drugs. any mixture of two or more of the alu- (2) Hexyl, octyl, and decyl; manufac- minum, calcium, magnesium, potas- tured by fractional distillation of alco- sium, and sodium salts of the fatty hols obtained by a sequence of oxida- acids conforming with § 172.860 and/or tion, hydrolysis, and catalytic hydro- oleic acid derived from tall oil fatty genation (catalyst consists of copper, acids conforming with § 172.862. chromium, and nickel) of organo-alu- (b) The food additive is used or in- minums generated by the controlled re- tended for use as a binder, emulsifier, action of low molecular weight and anticaking agent in food in accord- trialkylaluminum with purified ethyl- ance with good manufacturing prac- ene (minimum 99 percent by volume tice. C2H4), and utilizing an external coolant (c) To assure safe use of the additive, such that these alcohols meet the spec- the label and labeling of the additive ifications prescribed in paragraph (a)(1) and any premix thereof shall bear, in (i) and (iii) of this section. addition to the other information re- (b) The hydrocarbon solvent used in quired by the Act, the following: the process described in paragraph (1) The common or usual name of the (a)(1) of this section is a mixture of liq- fatty acid salt or salts contained there- uid hydrocarbons essentially paraffinic in. in nature, derived from petroleum and (2) The words ‘‘food grade,’’ in jux- refined to meet the specifications de- taposition with and equally as promi- scribed in paragraph (b)(1) of this sec- nent as the name of the salt. tion when subjected to the procedures described in paragraph (b) (2) and (3) of § 172.864 Synthetic fatty alcohols. this section. Synthetic fatty alcohols may be safe- (1) The hydrocarbon solvent meets ly used in food and in the synthesis of the following specifications: food components in accordance with (i) Boiling-point range: 175 °C–275 °C. the following prescribed conditions: (ii) Ultraviolet absorbance limits as (a) The food additive consists of any follows: one of the following fatty alcohols: Maximum (1) Hexyl, octyl, decyl, lauryl, absorb- myristyl, cetyl, and stearyl; manufac- ance per Wavelength (millicrons) centimeter tured by fractional distillation of alco- optical hols obtained by a sequence of oxida- path length tion and hydrolysis of organo-alu- 280–289 ...... 0.15 minums generated by the controlled re- 290–299 ...... 12 action of low molecular weight 300–359 ...... 05

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Maximum drilled holes (one-eighth inch in diameter) to absorb- the one-fourth-inch tube, one on each side at ance per the 5-, 7.5-, 10- and 12.5-inch points; the one- Wavelength (millicrons) centimeter optical eighth-inch copper tubes are bent to conform path length with the inner periphery of the oven. Beakers. 250-milliliter and 500-milliliter ca- 360–400 ...... 02 pacity. Graduated cylinders. 25-milliliter, 50-milli- (2) Use ASTM method D86–82, liter, and 150-milliliter capacity. ‘‘Standard Method for Distillation of Tuberculin syringe. 1-milliliter capacity, Petroleum Products,’’ which is incor- with 3-inch, 22-gauge needle. porated by reference, to determine Volumetric flask. 5-milliliter capacity. boiling point range. Copies of the ma- Spectrophotometric cells. Fused quartz terial incorporated by reference may ground glass stoppered cells, optical path length in the range of 1.000 centimeter ±0.005 be obtained from the American Society centimeter. With distilled water in the cells, for Testing Materials, 1916 Race St., determine any absorbance difference. Philadelphia, PA 19103, or may be ex- Spectrophotometer. Spectral range 250 milli- amined at the Office of the Federal microns—400 millimicrons with spectral slit Register, 800 North Capitol Street, width of 2 millimicrons or less: under instru- NW., suite 700, Washington, DC 20408. ment operating conditions for these absorb- (3) The analytical method for deter- ance measurements, the spectrophotometer mining ultraviolet absorbance limits is shall also meet the following performance requirements: as follows: Absorbance repeatability, ±0.01 at 0.4 absorbance. GENERAL INSTRUCTIONS Absorbance accuracy,1 ±0.05 at 0.4 absorb- All glassware should be scrupulously ance. ± cleaned to remove all organic matter such as Wavelength repeatability, 0.2 milli- oil, grease, detergent residues, etc. Examine micron. ± all glassware, including stoppers and stop- Wavelength accuracy, 1.0 millimicron. cocks, under ultraviolet light to detect any Nitrogen cylinder. Water-pumped or equiva- residual fluorescent contamination. As a pre- lent purity nitrogen in cylinder equipped cautionary measure, it is recommended prac- with regulator and valve to control flow at 5 tice to rinse all glassware with purified iso- p.s.i.g. octane immediately before use. No grease is REAGENTS AND MATERIALS to be used on stopcocks or joints. Great care to avoid contamination of hydrocarbon sol- Organic solvents. All solvents used through- vent samples in handling and to assure about the procedure shall meet the specifica- sence of any extraneous material arising tions and tests described in this specifica- from inadequate packaging is essential. Be- tion. The isooctane, benzene, hexane, and 1,2- cause some of the polynuclear hydrocarbons dichloroethane designated in the list fol- sought in this test are very susceptible to lowing this paragraph shall pass the fol- photo-oxidation, the entire procedure is to lowing test: be carried out under subdued light. To the specified quantity of solvent in a 250-milliliter beaker, add 1 milliliter of puri- APPARATUS fied n-hexadecane and evaporate in the vacu- Chromatographic tube. 450 millimeters in um oven under a stream of nitrogen. Dis- length (packing section), inside diameter 19 continue evaporation when not over 1 milli- millimeters ±1 millimeter, equipped with a liter of residue remains. (To the residue from wad of clean Pyrex brand filtering wool (Cor- ning Glass Works Catalog No. 3950 or equiva- 1 As determined by using potassium chro- lent). The tube shall contain a 250-milliliter mate for reference standard and described in reservoir and a 2-millimeter tetrafluoro- National Bureau of Standards Circular 484, ethylene polymer stopcock at the opposite Spectrophotometry, U.S. Department of end. Overall length of the tube is 670 milli- Commerce, (1949). The accuracy is to be de- meters. termined by comparison with the standard Stainless steel rod. 2 feet in length, 2 to 4 values at 290, 345, and 400 millimicrons. Cir- millimeters in diameter. cular 484 is incorporated by reference. Copies Vacuum oven. Similar to Labline No. 3610 are available from the Center for Food Safe- but modified as follows: A copper tube one- ty and Applied Nutrition (HFS–200), Food fourth inch in diameter and 13 inches in and Drug Administration, 5100 Paint Branch length is bent to a right angle at the 4-inch Pkwy., College Park, MD 20740, or available point and plugged at the opposite end; eight for inspection at the Office of the Federal copper tubes one-eighth inch in diameter and Register, 800 North Capitol Street, NW., 5 inches in length are silver soldered in suite 700, Washington, DC 20408.

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benzene add a 5-milliliter portion of purified PROCEDURE isooctane, reevaporate, and repeat once to insure complete removal of benzene.) Determination of ultraviolet absorbance. Be- Dissolve the 1 milliliter of hexadecane res- fore proceeding with the analysis of a sample idue in isooctane and make to 5 milliliters determine the absorbance in a 1-centimeter volume. Determine the absorbance in the 1- path cell for the reagent blank by carrying centimeter path length cells compared to out the procedure without a sample. Record isooctane as reference. The absorbance of the the absorbance in the wavelength range of solution of the solvent residue shall not ex- 280 to 400 millimicrons. Typical reagent ceed 0.02 per centimeter path length between blank absorbance in this range should not 280 and 300 mµ and shall not exceed 0.01 per exceed 0.04 in the 280 to 299 millimicron centimeter path length between 300 and 400 range, 0.02 in the 300 to 359 millimicron mµ. range, and 0.01 in the 360 to 400 millimicron Isooctane (2,2,4-trimethylpentane). Use 10 range. If the characteristic benzene peaks in milliliters for the test described in the pre- the 250 to 260 millimicron region are present, ceding paragraph. If necessary, isooctane remove the benzene by the procedure de- may be purified by passage through a column scribed above under ‘‘Reagents and Mate- of activated silica gel (Grade 12, Davison rials,’’ ‘‘Organic Solvents,’’ and record ab- Chemical Co., Baltimore, Md., or equiva- sorbance again. lent). Transfer 50 grams of silica gel to the Benzene, spectro grade (Burdick and Jackson chromatographic tube for sample analysis. Laboratories, Inc., Muskegon, Mich., or equiva- Raise and drop the column on a semisoft, lent). Use 80 milliliters for the test. If nec- clean surface for about 1 minute to settle the essary, benzene may be purified by distillation or otherwise. gel. Pour 100 milliliters of hexane into the Hexane, spectro grade (Burdick and Jackson column with the stopcock open and allow to Laboratories, Inc., Muskegon, Mich., or equiva- drain to about one-half inch above the gel. lent). Use 650 milliliters for the test. If nec- Turn off the stopcock and allow the column essary, hexane may be purified by distilla- to cool for 30 minutes. After cooling, vibrate tion or otherwise. the column to eliminate air and stir the top 1,2-Dichloroethane, spectro grade (Matheson, 1 to 2 inches with a small diameter stainless Coleman, and Bell, East Rutherford, N.J., or steel rod. Take care not to get the gel above equivalent). Use 20 milliliters for test. If nec- the liquid and onto the sides of the column. essary, 1,2-dichloroethane may be purified by Weigh out 40 grams ±0.1 gram of the hydro- distillation. carbon solvent sample into a 250-milliliter Eluting mixtures: beaker, add 50 milliliters of hexane, and pour 1. 10 percent 1,2-dichloroethane in hexane. the solution into the column. Rinse the Pipet 100 milliliters of 1,2-dichloroethane beaker with 50 milliliters of hexane and add into a 1-liter glass-stoppered volumetric this to the column. Allow the hexane sample flask and adjust to volume with hexane, with solution to elute into a 500-milliliter beaker mixing. until the solution is about one-half inch 2. 40 percent benzene in hexane. Pipet 400 above the gel. Rinse the column three times milliliters of benzene into a 1-liter glass- with 50-milliliter portions of hexane. Allow stoppered volumetric flask and adjust to vol- each hexane rinse to separately elute to ume with hexane, with mixing. about one-half inch above the gel. Replace n-Hexadecane, 99 percent olefin-free. Dilute the eluate beaker (discard the hexane eluate) 1.0 milliliter of n-hexadecane to 5 milliliters with a 250-milliliter beaker. Add two sepa- with isooctane and determine the absorbance rate 25-milliliter portions of 10 percent 1,2- in a 1-centimeter cell compared to isooctane dichloroethane and allow each to separately as reference between 280 mµ-400mµ. The ab- elute as before. Finally, add 150 milliliters of sorbance per centimeter path length shall 10 percent 1,2-dichloroethane for a total of not exceed 0.00 in this range. If necessary, n- 200 milliliters. When the final 10 percent 1,2- hexadecane may be purified by percolation through activated silica gel or by distilla- dichloroethane fraction is about one-half tion. inch above the top of the gel bed, replace the Silica gel, 28–200 mesh (Grade 12, Davison receiving beaker (discard the 1,2- Chemical Co., Baltimore, Md., or equivalent). dichloroethane eluate) with a 250-milliliter Activate as follows: Weigh about 900 grams beaker containing 1 milliliter of hexadecane. into a 1-gallon bottle, add 100 milliliters of Adjust the elution rate to 2 to 3 milliliters de-ionized water, seal the bottle and shake per minute, add two 25-milliliter portions of and roll at intervals for 1 hour. Allow to 40 percent benzene and allow each to sepa- equilibrate overnight in the sealed bottle. rately elute as before to within about one- Activate the gel at 150 °C for 16 hours, in a half inch of the gel bed. Finally, add 150 mil- 2-inch × 7-inch × 12-inch porcelain pan loose- liliters of 40 percent benzene for a total of 200 ly covered with aluminum foil, cool in a milliliters. Evaporate the benzene in the dessicator, transfer to a bottle and seal. oven with vacuum and sufficient nitrogen

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flow to just ripple the top of the benzene so- oils or fatty acid sources that are gen- lution. When the benzene is removed (as de- erally recognized as safe or approved termined by a constant volume of hexa- for use as food ingredients. The chain decane) add 5 milliliters of isooctane and evaporate. Repeat once to insure complete lengths of the fatty acids are no less removal of benzene. Remove the beaker and than 12 carbon atoms. cover with aluminum foil (previously rinsed (b) Olestra meets the following speci- with hexane) until cool. fications: Quantitatively transfer the hexadecane (1) The total content of octa-, hepta- residue to a 5-milliliter volumetric flask and dilute to volume with isooctane. Determine , and hexa-esters is not less than 97 per- the absorbance of the solution in 1-centi- cent as determined by a method enti- meter path length cells between 280 and 400 tled ‘‘Determination of Olestra by Size millimicrons using isooctane as a reference. Exclusion Chromatography,’’ dated De- Correct the absorbance values for any ab- cember 19, 1995, which is incorporated sorbance derived from reagents as deter- by reference in accordance with 5 mined by carrying out the procedure without a sample. If the corrected absorbance does U.S.C. 552(a) and 1 CFR part 51. Copies not exceed the limits prescribed in para- are available from the Office of Pre- graph (b)(1)(ii) of this section, the sample market Approval, Center for Food meets the ultraviolet absorbance specifica- Safety and Applied Nutrition (HFS– tions for hydrocarbon solvent. 200), Food and Drug Administration, (c) Synthetic fatty alcohols may be 5100 Paint Branch Pkwy., College Park, used as follows: MD 20740, or may be examined at the (1) As substitutes for the cor- Center for Food Safety and Applied Nu- responding naturally derived fatty al- trition’s Library, 5100 Paint Branch cohols permitted in food by existing Pkwy., College Park, MD 20740, or at regulations in this part or part 173 of the Office of the Federal Register, 800 this chapter provided that the use is in North Capitol Street, NW., suite 700, compliance with any prescribed limita- Washington, DC. tions. (2) The content of octa-ester is not (2) As substitutes for the cor- less than 70 percent as determined by a responding naturally derived fatty al- method entitled ‘‘Measurement of the cohols used as intermediates in the Relative Ester Distribution of Olestra synthesis of food additives and other Test Material’’ dated December 19, substances permitted in food. 1995, which is incorporated by reference [42 FR 14491, Mar. 15, 1977, as amended at 47 in accordance with 5 U.S.C. 552(a) and 1 FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, CFR part 51. Copies are available from 1984; 54 FR 24897, June 12, 1989] the Office of Premarket Approval, Cen- ter for Food Safety and Applied Nutri- § 172.866 Synthetic glycerin produced by the hydrogenolysis of carbo- tion (HFS–200), Food and Drug Admin- hydrates. istration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be ex- Synthetic glycerin produced by the amined at the Center for Food Safety hydrogenolysis of carbohydrates may and Applied Nutrition’s Library, 5100 be safely used in food, subject to the Paint Branch Pkwy., College Park, MD provisions of this section: (a) It shall contain not in excess of 20740, or at the Office of the Federal 0.2 percent by weight of a mixture of Register, 800 North Capitol Street, butanetriols. NW., suite 700, Washington, DC. (b) It is used or intended for use in an (3) The content of hexa-ester is not amount not to exceed that reasonably more than 1 percent as determined by required to produce its intended effect. the method listed in paragraph (b)(2) of this section. § 172.867 Olestra. (4) The content of penta-ester is not Olestra, as identified in this section, more than 0.5 percent as determined by may be safely used in accordance with the method listed in paragraph (b)(2) of the following conditions: this section. (a) Olestra is a mixture of octa-, (5) The unsaturated fatty acid con- hepta-, and hexa-esters of sucrose with tent is not less than 25 percent (thus fatty acids derived from edible fats and not more than 75 percent saturated

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fatty acid) and not more than 83 per- amined at the Center for Food Safety cent as determined by a method enti- and Applied Nutrition’s Library, 5100 tled ‘‘Measurement of the Fatty Acid Paint Branch Pkwy., College Park, MD Composition of Olestra Test Material,’’ 20740, or at the Office of the Federal dated December 19, 1995, which is incor- Register, 800 North Capitol Street, porated by reference in accordance NW., suite 700, Washington, DC. with 5 U.S.C. 552(a) and 1 CFR part 51. (10) The total heavy metal content Copies are available from the Office of (as Pb) is not more than 10 parts per Premarket Approval, Center for Food million. Safety and Applied Nutrition (HFS– (11) Lead is not more than 0.1 part 200), Food and Drug Administration, per million, as determined by a method 5100 Paint Branch Pkwy., College Park, entitled ‘‘Atomic Absorption MD 20740, or may be examined at the Spectrophotometric Graphite Furnace Center for Food Safety and Applied Nu- Method,’’ Food Chemicals Codex, 3d Ed. trition’s Library, 5100 Paint Branch 3d Supp. p. 168 (1992), which is incor- Pkwy., College Park, MD 20740, or at porated by reference in accordance the Office of the Federal Register, 800 with 5 U.S.C. 552(a) and 1 CFR part 51. North Capitol Street, NW., suite 700, Copies are available from the National Washington, DC. Research Council Press, 2101 Constitu- (6) The content of C12 and C14 fatty tion Ave. NW., Washington, DC, or may acids is each not more than 1 percent, be examined at the Center for Food and total C20 and longer fatty acids is Safety and Applied Nutrition’s Li- not more than 20 percent. C16 and C18 brary, 5100 Paint Branch Pkwy., Col- fatty acids make up the remainder lege Park, MD 20740, or at the Office of with total content not less than 78 per- the Federal Register, 800 North Capitol cent as determined by the method list- Street, NW., suite 700, Washington, DC. ed in paragraph (b)(5) of this section. (7) The free fatty acid content is not (12) Water is not more than 0.1 per- more than 0.5 percent as determined by cent, as determined by a method enti- a method entitled ‘‘Free Fatty Acids’’ tled ‘‘Moisture,’’ Official Methods and published in the Official Methods and Recommended Practices of the American Recommended Practices of the American Oil Chemists’ Society, 4th Ed. (1989), vol. Oil Chemists’ Society, 3d Ed. (1985) vol. 1, 1, which is incorporated by reference in which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from CFR part 51. Copies are available from the American Oil Chemists Society, the American Oil Chemists Society, 1608 Broadmoor Dr., Champaign, IL 1608 Broadmoor Dr., Champaign, IL 61821, or may be examined at the Cen- 61821, or may be examined at the Cen- ter for Food Safety and Applied Nutri- ter for Food Safety and Applied Nutri- tion’s Library, 5100 Paint Branch tion’s Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at Pkwy., College Park, MD 20740, or at the Office of the Federal Register, 800 the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, North Capitol Street, NW., suite 700, Washington, DC. Washington, DC. (13) Peroxide value is not more than (8) The residue on ignition (sulfated 10 meq/kg as determined by a method ash) is not more than 0.5 percent. entitled ‘‘Peroxide Value,’’ Official (9) Total methanol content is not Methods and Recommended Practices of more than 300 parts per million as de- the American Oil Chemists’ Society, 4th termined by the ‘‘Total Available Ed. (1989) vol. 1, which is incorporated Methanol Method,’’ dated December 19, by reference in accordance with 5 1995, which is incorporated by reference U.S.C. 552(a) and 1 CFR part 51. Copies in accordance with 5 U.S.C. 552(a) and 1 are available from the American Oil CFR part 51. Copies are available from Chemists Society, 1608 Broadmoor Dr., the Office of Premarket Approval, Cen- Champaign, IL 61821, or may be exam- ter for Food Safety and Applied Nutri- ined at the Center for Food Safety and tion (HFS–200), Food and Drug Admin- Applied Nutrition’s Library, 5100 Paint istration, 5100 Paint Branch Pkwy., Branch Pkwy., College Park, MD 20740, College Park, MD 20740 or may be ex- or at the Office of the Federal Register,

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800 North Capitol Street, NW., suite (2) Olestra shall not be considered as 700, Washington, DC. a source of fat or calories for purposes (14) The stiffness is not less than 50 of §§ 101.9 and 101.13 of this chapter. kiloPascals/second, as determined by a (f) Consistent with its obligation to method entitled ‘‘Method for Measure- monitor the safety of all additives in ment of the Stiffness of Olestra,’’ dated the food supply, including olestra, the December 19, 1995, which is incor- Food and Drug Administration will re- porated by reference in accordance view and evaluate all data and infor- with 5 U.S.C. 552(a) and 1 CFR part 51. mation bearing on the safety of olestra received by the agency after the effec- Copies are available from the Office of tive date of this regulation, and will Premarket Approval, Center for Food present such data, information, and Safety and Applied Nutrition (HFS– evaluation to the agency’s Food Advi- 200), Food and Drug Administration, sory Committee within 30 months of 5100 Paint Branch Pkwy., College Park, the effective date of this regulation. MD 20740, or may be examined at the The purpose of such presentation will Center for Food Safety and Applied Nu- be to receive advice from the Com- trition’s Library, 5100 Paint Branch mittee on whether there continues to Pkwy., College Park, MD 20740, or at be reasonable certainty that use of the Office of the Federal Register, 800 olestra in compliance with this regula- North Capitol St. NW., suite 700, Wash- tion is not harmful. The agency will ington, DC. hold such additional Food Advisory (c) Olestra may be used in place of Committee meetings on olestra as the fats and oils in prepackaged ready-to- agency determines, in its discretion, to eat savory (i.e., salty or piquant but be necessary. Based upon the results of not sweet) snacks. In such foods, the this entire process, the FDA will ini- additive may be used in place of fats tiate any appropriate regulatory pro- and oils for frying or baking, in dough ceedings. conditioners, in sprays, in filling ingre- [61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, dients, or in flavors. 1996, as amended at 68 FR 46402, Aug. 5, 2003] (d) To compensate for any inter- ference with absorption of fat soluble § 172.868 Ethyl cellulose. vitamins, the following vitamins shall The food additive ethyl cellulose may be added to foods containing olestra: be safely used in food in accordance 1.9 milligrams alpha-tocopherol equiva- with the following prescribed condi- lents per gram olestra; 51 retinol tions: equivalents per gram olestra (as (a) The food additive is a cellulose retinyl acetate or retinyl palmitate); 12 ether containing ethoxy (OC2H5) groups IU vitamin D per gram olestra; and 8 µg attached by an ether linkage and containing on an anhydrous basis not more vitamin K1 per gram olestra. (e)(1) Vitamins A, D, E, and K present than 2.6 ethoxy groups per in foods as a result of the requirement anhydroglucose unit. (b) It is used or intended for use as in paragraph (d) of this section shall be follows: declared in the listing of ingredients. (1) As a binder and filler in dry vita- Such vitamins shall not be considered min preparations. in determining nutrient content for the (2) As a component of protective nutritional label or for any nutrient coatings for vitamin and mineral tab- claims, express or implied. lets. (i) An asterisk shall follow vitamins (3) As a fixative in flavoring com- A, D, E, and K in the listing of ingredi- pounds. ents; (ii) The asterisk shall appear as a su- § 172.869 Sucrose oligoesters. perscript following each vitamin; Sucrose oligoesters, as identified in (iii) Immediately following the ingre- this section, may be safely used in ac- dient list an asterisk and statement, cordance with the following conditions: ‘‘Dietarily insignificant’’ shall appear (a) Sucrose oligoesters consist of prominently and conspicuously as spec- mixtures of sucrose fatty acid esters ified in § 101.2(c) of this chapter; with an average degree of

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esterification ranging from four to cited for determining compliance with seven. It is produced by each specification are incorporated by interesterification of sucrose with reference, in accordance with 5 U.S.C. methyl esters of fatty acids derived 552(a) and 1 CFR part 51. Copies of the from edible fats and oils (including hy- methods may be examined at the Cen- drogenated fats and oils). The only sol- ter for Food Safety and Applied Nutri- vents which may be used in the prepa- tion’s Library, room 1C–100, 5100 Paint ration of sucrose oligoesters are di- Branch Pkwy., College Park, MD 20740, methyl sulfoxide, isobutyl alcohol, and or at the Office of the Federal Register, those solvents generally recognized as 800 North Capitol St. NW., suite 700, safe in food. Washington, DC. Copies of the methods (b) Sucrose oligoesters meet the specifications in the methods listed in the are available from the sources listed in table in this paragraph. The methods the table in this paragraph:

Specification Limit Method Cited Source for Obtaining Method

(1) Sucrose esters ...... Not less than 90% ...... ‘‘Method for Analyzing the Pu- Office of Food Additive Safe- rity of Sucrose Fatty Acid ty, Center for Food Safety Esters,’’ issued by and Applied Nutrition (HFS– Mitsubishi Chemical Corp., 200), Food and Drug Ad- June 17, 1998. ministration, 5100 Paint Branch Pkwy., College Park, MD 20740.

(2) Mono-, di-, and tri-esters ... Not more than 45% ...... ‘‘Method for Measuring the Do. Ester Distribution of Su- crose Oligoesters,’’ issued by Mitsubishi Chemical Corp., June 17, 1998.

(3) Tetra-, penta-, hexa-, and Not less than 50% ...... Do. Do. hepta-esters.

(4) Octa-esters ...... Not more than 40% ...... Do. Do.

(5) Free Sucrose ...... Not more than 0.5% ...... ‘‘Free Sucrose Method,’’ Do. issued by Mitsubishi Chem- ical Corp., June 17, 1998.

(6) Acid Value ...... Not more than 4.0 ...... ‘‘Acid Value,’’ Appendix VII, National Academy Press, Method I (Commercial Fatty 2101 Constitution Ave. NW, Acids), in the Food Chemi- Washington, DC 20418 cals Codex, 4th ed. (1996), (Internet: http:// p. 820. www.nap.edu).

(7) Residue on Ignition ...... Not more than 0.7% ...... ‘‘Residue on Ignition, Appen- Do. dix IIC, Method I, in the Food Chemicals Codex, 4th ed. (1996), pp. 751–752, (using a 1-gram sample).

(8) Residual Methanol ...... Not more than 10 milligrams/ Method listed in the mono- Do. kilogram. graph for ‘‘Sucrose Fatty Acid Esters’’ in the First Supplement to the 4th ed. of the Food Chemicals Codex (1997), pp. 44–45.

(9) Residual Dimethyl Sulf- Not more than 2.0 milligrams/ Do. Do. oxide. kilogram.

(10) Residual Isobutyl Alcohol Not more than 10 milligrams/ Do. Do. kilogram.

(11) Lead ...... Not more than 1.0 milligram/ ‘‘Atomic Absorption Do. kilogram. Spectrophotometric Graph- ite Furnace Method,’’ Meth- od I, in the Food Chemicals Codex, 4th ed. (1996), pp. 763–765.

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(c) The additive is used as an emulsi- § 172.872 Methyl ethyl cellulose. fier (as defined in § 170.3(o)(8) of this The food additive methyl ethyl cel- chapter) or stabilizer (as defined in lulose may be safely used in food in ac- § 170.3(o)(28) of this chapter) in chocolate and in butter-substitute spreads, cordance with the following prescribed at a level not to exceed 2.0 percent; ex- conditions. cept that the additive may not be used (a) The additive is a cellulose ether in a standardized food unless permitted having the general formula [C6H(10–x– by the standard of identity. y)O5(CH3)x(C2H5)y]n, where x is the number of methyl groups and y is the num- [68 FR 50072, Aug. 20, 2003] ber of ethyl groups. The average value of x is 0.3 and the average value of y is § 172.870 Hydroxypropyl cellulose. 0.7. The food additive hydroxypropyl cel- (b) The additive meets the following lulose may be safely used in food, ex- specifications: cept standardized foods that do not (1) The methoxy content shall be not provide for such use, in accordance less than 3.5 percent and not more than with the following prescribed condi- 6.5 percent, calculated as OCH3, and the tions: ethoxy content shall be not less than (a) The additive consists of one of the 14.5 percent and not more than 19 per- following: cent, calculated as OC2H5, both meas- (1) A cellulose ether containing pro- ured on the dry sample. pylene glycol groups attached by an (2) The viscosity of an aqueous solu- ether linkage which contains, on an an- tion, 2.5 grams of the material in 100 hydrous basis, not more than 4.6 milliliters of water, at 20 °C, is 20 to 60 hydroxypropyl groups per centipoises. anhydroglucose unit. The additive has a minimum viscosity of 145 centipoises (3) The ash content on a dry basis has for 10 percent by weight aqueous solu- a maximum of 0.6 percent. tion at 25 °C. (c) The food additive is used as an (2) A cellulose ether containing pro- aerating, emulsifying, and foaming pylene glycol groups attached by an agent, in an amount not in excess of ether linkage having a hydroxypropoxy that reasonably required to produce its intended effect. (OC3H6OH) content of 5 to 16 percent weight in weight (w/w) on an anhydrous basis, i.e., 0.1 to 0.4 hydroxypropyl § 172.874 Hydroxypropyl groups per anhydroglucose unit. The methylcellulose. common name for this form of the ad- The food additive hydroxypropyl ditive is low substituted hydroxypropyl methylcellulose (CAS Reg. No. 9004–65– cellulose. 3) may be safely used in food, except in (b) The additive is used or intended standardized foods which do not pro- for use as follows: vide for such use if: (1) The additive identified in para- (a) The additive complies with the graph (a)(1) of this section is used or definition and specifications prescribed intended for use as an emulsifier, film in the National Formulary, 12th edi- former, protective colloid, stabilizer, tion. suspending agent, or thickener, in ac- (b) It is used or intended for use as an cordance with good manufacturing emulsifier, film former, protective col- practice. loid, stabilizer, suspending agent, or (2) The additive identified in para- thickener, in accordance with good graph (a)(2) of this section is used or manufacturing practice. intended for use as a binder and dis- (c) To insure safe use of the additive, integrator in tablets or wafers con- the container of the additive, in addi- taining dietary supplements of vita- tion to being labeled as required by the mins and/or minerals. The additive is general provisions of the act, shall be used in accordance with good manufac- accompanied by labeling which con- turing practice. tains adequate directions for use to [46 FR 50065, Oct. 9, 1981] provide a final product that complies

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with the limitations prescribed in para- (1) It meets the test requirements of graph (b) of this section. the United States Pharmacopeia XX [42 FR 14491, Mar. 15, 1977, as amended at 47 (1980) for readily carbonizable sub- FR 38273, Aug. 31, 1982] stances (page 532). (2) It meets the test requirements of § 172.876 Castor oil. U.S.P. XVII for sulfur compounds (page The food additive castor oil may be 400). safely used in accordance with the fol- (3) It meets the specifications pre- lowing conditions: scribed in the ‘‘Journal of the Associa- (a) The additive meets the specification of Official Analytical Chemists,’’ tions of the United States Pharma- Volume 45, page 66 (1962), which is in- copeia XX (1980). corporated by reference, after correc- (b) The additive is used or intended tion of the ultraviolet absorbance for for use as follows: any absorbance due to added anti- Use and Limitations oxidants. Copies of the material incorporated by reference are available from Hard candy production—As a release agent the Center for Food Safety and Applied and antisticking agent, not to exceed 500 parts per million in hard candy. Nutrition (HFS–200), Food and Drug Vitamin and mineral tablets—As a compo- Administration, 5100 Paint Branch nent of protective coatings. Pkwy., College Park, MD 20740, or [42 FR 14491, Mar. 15, 1977, as amended at 49 available for inspection at the Office of FR 10105, Mar. 19, 1984] the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC § 172.878 White mineral oil. 20408. White mineral oil may be safely used (b) White mineral oil may contain in food in accordance with the fol- any antioxidant permitted in food by lowing conditions: regulations issued in accordance with (a) White mineral oil is a mixture of section 409 of the Act, in an amount liquid hydrocarbons, essentially par- not greater than that required to affinic and naphthenic in nature ob- produce its intended effect. tained from petroleum. It is refined to (c) White mineral oil is used or in- meet the following specifications: tended for use as follows:

Limitation (inclusive of all petroleum hydro- Use carbons that may be used in combination with white mineral oil)

1. As a release agent, binder, and lubricant in or on capsules and tablets con- Not to exceed 0.6% of the capsule or tab- taining concentrates of flavoring, spices, condiments, and nutrients intended for let. addition to food, excluding confectionery. 2. As a release agent, binder, and lubricant in or on capsules and tablets con- Not to exceed 0.6% of the capsule or tab- taining food for special dietary use. let. 3. As a float on fermentation fluids in the manufacture of vinegar and wine to pre- In an amount not to exceed good manu- vent or retard access of air, evaporation, and wild yeast contamination during facturing practice. fermentation. 4. As a defoamer in food ...... In accordance with § 173.340 of this chapter. 5. In bakery products, as a release agent and lubricant ...... Not to exceed 0.15% of bakery products. 6. In dehydrated fruits and vegetables, as a release agent ...... Not to exceed 0.02% of dehydrated fruits and vegetables. 7. In egg white solids, as a release agent ...... Not to exceed 0.1% of egg white solids. 8. On raw fruits and vegetables, as a protective coating ...... In an amount not to exceed good manufacturing practice. 9. In frozen meat, as a component of hot-melt coating ...... Not to exceed 0.095% of meat. 10. As a protective float on brine used in the curing of pickles ...... In an amount not to exceed good manufacturing practice. 11. In molding starch used in the manufacture of confectionery ...... Not to exceed 0.3 percent in the molding starch. 12. As a release agent, binder, and lubricant in the manufacture of yeast ...... Not to exceed 0.15 percent of yeast. 13. As an antidusting agent in sorbic acid for food use ...... Not to exceed 0.25 percent in the sorbic acid. 14. As release agent and as sealing and polishing agent in the manufacture of Not to exceed 0.2 percent of confectionery. confectionery. 15. As a dust control agent for wheat, corn, soybean, barley, rice, rye, oats, and Applied at a level of no more than 0.02 sorghum. percent by weight of grain.

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Limitation (inclusive of all petroleum hydro- Use carbons that may be used in combination with white mineral oil)

16. As a dust control agent for rice ...... ISO 100 oil viscosity (100 centistokes (cSt) at 100°F) applied at a level of no more than 0.08 percent by weight of the rice grain.

[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 8764, Mar. 2, 1982; 47 FR 11838, Mar. 19, 1982; 48 FR 55728, Dec. 15, 1983; 49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 63 FR 66014, Dec. 1, 1998]

§ 172.880 Petrolatum. subjected to the analytical procedure described in § 172.886(b): Petrolatum may be safely used in food, subject to the provisions of this Ultraviolet absorbance per centimeter section. path length: (a) Petrolatum complies with the Millimicrons Maximum specifications set forth in the United States Pharmacopeia XX (1980) for 280–289 ...... 0.25 290–299 ...... 20 white petrolatum or in the National 300–359 ...... 14 Formulary XV (1980) for petrolatum. 360–400 ...... 04 (b) Petrolatum meets the following ultraviolet absorbance limits when (c) Petrolatum is used or intended for use as follows:

Limitation (inclusive of all petroleum hydrocarbons Use that may be used in combination with petrolatum)

In bakery products; as release agent and lubricant ...... With white mineral oil, not to exceed 0.15 percent of bakery product. In confectionery; as release agent and as sealing and polishing agent ... Not to exceed 0.2 percent of confectionery. In dehydrated fruits and vegetables; as release agent ...... Not to exceed 0.02 percent of dehydrated fruits and vegetables. In egg white solids; as release agent ...... Not to exceed 0.1 percent of egg white solids. On raw fruits and vegetables; as protective coating ...... In an amount not to exceed good manufacturing practice. In beet sugar and yeast; as defoaming agent ...... As prescribed in § 173.340 of this chapter.

(d) Petrolatum may contain any Distillation of Petroleum Products,’’ which antioxidant permitted in food by regu- is incorporated by reference. Copies may be lations issued in accordance with sec- obtained from the American Society for Testing Materials, 1916 Race St., Philadel- tion 409 of the Act, in an amount not phia, PA 19103, or may be examined at the greater than that required to produce Office of the Federal Register, 800 North Cap- its intended effect. itol Street, NW., suite 700, Washington, DC 20408. [42 FR 14491, Mar. 15, 1977, as amended at 49 Ultraviolet absorbance: FR 10105, Mar. 19, 1984] 260–319 millimicrons—1.5 maximum. 320–329 millimicrons—0.08 maximum. § 172.882 Synthetic isoparaffinic petro- 330–350 millimicrons—0.05 maximum. leum hydrocarbons. Nonvolatile residual: 0.002 gram per 100 Synthetic isoparaffinic petroleum milliliters maximum. hydrocarbons may be safely used in Synthetic isoparaffinic petroleum hydrocarbons containing antioxidants shall meet food, in accordance with the following the specified ultraviolet absorbance limits conditions: after correction for any absorbance due to (a) They are produced by synthesis the antioxidants. The ultraviolet absorbance from petroleum gases and consist of a shall be determined by the procedure de- mixture of liquid hydrocarbons meet- scribed for application of mineral oil, dis- ing the following specifications: regarding the last sentence of the procedure, under ‘‘Specifications’’ on page 66 of the Boiling point 93–260 °C as determined by ‘‘Journal of the Association of Official Ana- ASTM method D86–82, ‘‘Standard Method for lytical Chemists,’’ Volume 45 (February

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1962), which is incorporated by reference. (a) The additive is a mixture of liquid Copies are available from the Center for hydrocarbons derived from petroleum Food Safety and Applied Nutrition (HFS– or synthesized from petroleum gases. 200), Food and Drug Administration, 5100 The additive is chiefly paraffinic, Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of isoparaffinic, or naphthenic in nature. the Federal Register, 800 North Capitol (b) The additive meets the following Street, NW., suite 700, Washington, DC 20408. specifications: For hydrocarbons boiling below 250 °F, the (1) Odor is faint and not kerosenic. nonvolatile residue shall be determined by (2) Initial boiling point is 300 °F min- ASTM method D1353–78, ‘‘Standard Test imum. Method for Nonvolatile Matter in Volatile Solvents for Use in Paint, Varnish, Lacquer, (3) Final boiling point is 650 °F max- and Related Products;’’ for those boiling imum. above 121 °C, ASTM method D381–80, ‘‘Stand- (4) Ultraviolet absorbance limits de- ard Test Method for Existent Gum in Fuels termined by method specified in by Jet Evaporation’’ shall be used. These § 178.3620(b)(1)(ii) of this chapter, as fol- methods are incorporated by reference. Cop- lows: ies may be obtained from the American Soci- ety for Testing Materials, 1916 Race St., Maximum Philadelphia, PA 19103, or may be examined absorb- at the Office of the Federal Register, 800 µ ance per Wavelength m centimeter North Capitol Street, NW., suite 700, Wash- optical ington, DC 20408. pathlength

(b) Isoparaffinic petroleum hydro- 280–289 ...... 4.0 carbons may contain antioxidants au- 290–299 ...... 3.3 thorized for use in food in an amount 300–329 ...... 2.3 not to exceed that reasonably required 330–360 ...... 8 to accomplish the intended technical effect nor to exceed any prescribed lim- (c) The additive is used as follows: itations. Use Limitations (c) Synthetic isoparaffinic petroleum hydrocarbons are used or intended for As a coating on shell eggs ...... In an amount not to exceed good manufac- use as follows: turing practice. As a defoamer in processing beet Complying with Uses Limitations sugar and yeast. § 173.340 of this chapter. 1. In the froth-flotation cleaning of In an amount not to ex- As a float on fermentation fluids in In an amount not to ex- vegetables. ceed good manufac- the manufacture of vinegar and ceed good manufacturing practice. wine to prevent or retard ac- turing practice. 2. As a component of insecticide Do. cess of air, evaporation, and formulations for use on proc- wild yeast contamination during essed foods. fermentation. 3. As a component of coatings on Do. In the froth-flotation cleaning of Do. fruits and vegetables. vegetables. 4. As a coating on shell eggs ...... Do. As a component of insecticide for- Do. 5. As a float on fermentation Do. mulations used in compliance fluids in the manufacture of vin- with regulations issued in parts egar and wine and on brine 170 through 189 of this chapter. used in curing pickles, to prevent or retard access of air, evaporation, and contamination § 172.886 Petroleum wax. with wild organisms during fermentation. Petroleum wax may be safely used in or on food, in accordance with the fol- [42 FR 14491, Mar. 15, 1977, as amended at 47 lowing conditions: FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, (a) Petroleum wax is a mixture of 1984; 54 FR 24897, June 12, 1989] solid hydrocarbons, paraffinic in nature, derived from petroleum, and re- § 172.884 Odorless light petroleum hy- fined to meet the specifications pre- drocarbons. scribed by this section. Odorless light petroleum hydro- (b) Petroleum wax meets the fol- carbons may be safely used in food, in lowing ultraviolet absorbance limits accordance with the following pre- when subjected to the analytical proce- scribed conditions: dure described in this paragraph.

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Maximum Condenser. 24/40 joints, fitted with a drying ultraviolet tube, length optional. absorbance per Evaporation flask (optional). 250–milliliter centimeter or 500–milliliter capacity all-glass flask path length equipped with standard taper stopper having inlet and outlet tubes to permit passage of 280–289 millimicrons ...... 0.15 nitrogen across the surface of contained liq- 290–299 millimicrons ...... 0.12 300–359 millimicrons ...... 0.08 uid to be evaporated. 360–400 millimicrons ...... 0.02 Vacuum distillation assembly. All glass (for purification of dimethyl sulfoxide); 2–liter distillation flask with heating mantle; ANALYTICAL SPECIFICATION FOR PETROLEUM Vigreaux vacuum-jacketed condenser (or WAX equivalent) about 45 centimeters in length GENERAL INSTRUCTIONS and distilling head with separable cold finger condenser. Use of tetrafluoroethylene poly- Because of the sensitivity of the test, the mer sleeves on the glass joints will prevent possibility of errors arising from contamina- freezing. Do not use grease on stopcocks or tion is great. It is of the greatest importance joints. that all glassware be scrupulously cleaned to Spectrophotometric cells. Fused quartz cells, remove all organic matter such as oil, optical path length in the range of 5.000 cen- grease, detergent residues, etc. Examine all timeters ±0.005 centimeter; also for checking glassware, including stoppers and stopcocks, spectrophotometer performance only, optical under ultraviolet light to detect any residual path length in the range 1.000 centimeter fluorescent contamination. As a pre- ±0.005 centimeter. With distilled water in the cautionary measure it is recommended prac- cells, determine any absorbance differences. tice to rinse all glassware with purified iso- Spectrophotometer. Spectral range 250 milli- octane immediately before use. No grease is microns–400 millimicrons with spectral slit to be used on stopcocks or joints. Great care width of 2 millimicrons or less, under instru- to avoid contamination of wax samples in ment operating conditions for these absorb- handling and to assure absence of any extra- ance measurements, the spectrophotometer neous material arising from inadequate shall also meet the following performance packaging is essential. Because some of the requirements: polynuclear hydrocarbons sought in this test Absorbance repeatability, ±0.01 at 0.4 ab- are very susceptible to photo-oxidation, the sorbance. entire procedure is to be carried out under Absorbance accuracy, 1 ±0.05 at 0.4 absorb- subdued light. ance. ± APPARATUS Wavelength repeatability, 0.2 millimicron. Separatory funnels. 250–milliliter, 500–milli- Wavelength accuracy, ±1.0 millimicron. liter, 1,000–milliliter, and preferably 2,000– Nitrogen cylinder. Water-pumped or equiva- milliliter capacity, equipped with tetra- lent purity nitrogen in cylinder equipped fluoroethylene polymer stopcocks. with regulator and valve to control flow at 5 Reservoir. 500–milliliter capacity, equipped p.s.i.g. with a 24/40 standard taper male fitting at the bottom and a suitable ball-joint at the REAGENTS AND MATERIALS top for connecting to the nitrogen supply. Organic solvents. All solvents used through- The male fitting should be equipped with out the procedure shall meet the specifica- glass hooks. tions and tests described in this specifica- Chromatographic tube. 180 millimeters in tion. The isooctane, benzene, acetone, and length, inside diameter to be 15.7 millimeters ±0.1 millimeter, equipped with a coarse, fritted-glass disc, a tetrafluoroethylene polymer 1 As determined by using potassium chro- stopcock, and a female 24/40 standard tapered mate for reference standard and described in fitting at the opposite end. (Overall length of National Bureau of Standards Circular 484, the column with the female joint is 235 milli- Spectrophotometry, U.S. Department of meters.) The female fitting should be Commerce, (1949). The accuracy is to be de- equipped with glass hooks. termined by comparison with the standard Disc. Tetrafluoroethylene polymer 2–inch values at 290, 345, and 400 millimicrons. Cir- diameter disc approximately 3⁄16–inch thick cular 484 is incorporated by reference. Copies with a hole bored in the center to closely fit are available from the Center for Food Safe- the stem of the chromatographic tube. ty and Applied Nutrition (HFS–200), Food Heating jacket. Conical, for 500–milliliter and Drug Administration, 5100 Paint Branch separatory funnel. (Used with variable trans- Pkwy., College Park, MD 20740, or available former heat control.) for inspection at the Office of the Federal Suction flask. 250–milliliter or 500–milliliter Register, 800 North Capitol Street, NW., filter flask. suite 700, Washington, DC 20408.

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methyl alcohol designated in the list fol- necessary, by percolation through activated lowing this paragraph shall pass the fol- silica gel or by distillation. lowing test: Methyl alcohol, A.C.S. reagent grade. Use To the specified quantity of solvent in a 10.0 milliliters of methyl alcohol. Purify, if 250–milliliter Erlenmeyer flask, add 1 milli- necessary, by distillation. liter of purified n-hexadecane and evaporate Dimethyl sulfoxide. Pure grade, clear, on the steam bath under a stream of nitro- water-white, m.p. 18° minimum. Dilute 120 gen (a) loose aluminum foil jacket around milliliters of dimethyl sulfoxide with 240 the flask will speed evaporation). Dis- milliliters of distilled water in a 500–milli- continue evaporation when not over 1 milliliter separatory funnel, mix and allow to liter of residue remains. (To the residue from cool for 5–10 minutes. Add 40 milliliters of benzene add a 10–milliliter portion of puri- isooctane to the solution and extract by fied isooctane, reevaporate, and repeat once shaking the funnel vigorously for 2 minutes. to insure complete removal of benzene.) Draw off the lower aqueous layer into a sec- Alternatively, the evaporation time can be ond 500–milliliter separatory funnel and re- reduced by using the optional evaporation peat the extraction with 40 milliliters of iso- flask. In this case the solvent and n-hexa- octane. Draw off and discard the aqueous decane are placed in the flask on the steam layer. Wash each of the 40–milliliter extrac- bath, the tube assembly is inserted, and a tives three times with 50–milliliter portions stream of nitrogen is fed through the inlet of distilled water. Shaking time for each tube while the outlet tube is connected to a wash is 1 minute. Discard the aqueous lay- solvent trap and vacuum line in such a way ers. Filter the first extractive through anhy- as to prevent any flow-back of condensate drous sodium sulfate prewashed with iso- into the flask. octane (see Sodium sulfate under ‘‘Reagents Dissolve the 1 milliliter of hexadecane res- and Materials’’ for preparation of filter), into idue in isooctane and make to 25 milliliters a 250–milliliter Erlenmeyer flask, or option- volume. Determine the absorbance in the 5– ally into the evaporating flask. Wash the centimeter path length cells compared to first separatory funnel with the second 40– isooctane as reference. The absorbance of the milliliter isooctane extractive, and pass solution of the solvent residue (except for through the sodium sulfate into the flask. methyl alcohol) shall not exceed 0.01 per cen- Then wash the second and first separatory timeter path length between 280 and 400 mµ. funnels successively with a 10–milliliter por- For methyl alcohol this absorbance value tion of isooctane, and pass the solvent shall be 0.00. through the sodium sulfate into the flask. Isooctane (2,2,4–trimethylpentane). Use 180 Add 1 milliliter of n-hexadecane and evapo- milliliters for the test described in the pre- rate the isooctane on the steam bath under ceding paragraph. Purify, if necessary, by nitrogen. Discontinue evaporation when not passage through a column of activated silica over 1 milliliter of residue remains. To the gel (Grade 12, Davison Chemical Company, residue, add a 10–milliliter portion of iso- Baltimore, Maryland, or equivalent) about 90 octane and reevaporate to 1 milliliter of centimeters in length and 5 centimeters to 8 hexadecane. Again, add 10 milliliters of iso- centimeters in diameter. octane to the residue and evaporate to 1 mil- Benzene, A.C.S. reagent grade. Use 150 milli- liliter of hexadecane to insure complete re- liters for the test. Purify, if necessary, by moval of all volatile materials. Dissolve the distillation or otherwise. 1 milliliter of hexadecane in isooctane and Acetone, A.C.S. reagent grade. Use 200 milli- make to 25–milliliter volume. Determine the liters for the test. Purify, if necessary, by reference. The absorbance of the solution distillation. should not exceed 0.02 per centimeter path Eluting mixtures: length in the 280 mµ–400 mµ range. (NOTE.— 1. 10 percent benzene in isooctane. Pipet 50 Difficulty in meeting this absorbance speci- milliliters of benzene into a 500–milliliter fication may be due to organic impurities in glass-stoppered volumetric flask and adjust the distilled water. Repetition of the test to volume with isooctane, with mixing. omitting the dimethyl sulfoxide will disclose 2. 20 percent benzene in isooctane. Pipet 50 their presence. If necessary to meet the spec- milliliters of benzene into a 250–milliliter ification, purify the water by redistillation, glass-stoppered volumetric flask, and adjust passage through an ion-exchange resin, or to volume with isooctane, with mixing. otherwise.) 3. Acetone-benzene-water mixture. Add 20 Purify, if necessary, by the following pro- milliliters of water to 380 milliliters of ace- cedure: To 1,500 milliliters of dimethyl sulf- tone and 200 milliliters of benzene, and mix. oxide in a 2–liter glass-stoppered flask, add n-Hexadecane, 99 percent olefin-free. Dilute 6.0 milliliters of phosphoric acid and 50 1.0 milliliter of n-hexadecane to 25 milliliters grams of Norit A (decolorizing carbon, alka- with isooctane and determine the absorbance line) or equivalent. Stopper the flask, and in a 5–centimeter cell compared to isooctane with the use of a magnetic stirrer (tetra- as reference point between 280 mµ–400 mµ. fluoroethylene polymer coated bar) stir the The absorbance per centimeter path length solvent for 15 minutes. Filter the dimethyl shall not exceed 0.00 in this range. Purify, if sulfoxide through four thicknesses of fluted

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paper (18.5 centimeters, Schleicher & prewash to provide such filters required in Schuell, No. 597, or equivalent). If the initial the method: Place approximately 35 grams of filtrate contains carbon fines, refilter anhydrous sodium sulfate in a 30–milliliter through the same filter until a clear filtrate coarse, fritted-glass funnel or in a 65–milli- is obtained. Protect the sulfoxide from air meter filter funnel with glass wool plug; and moisture during this operation by cov- wash with successive 15–milliliter portions of ering the solvent in the funnel and collection the indicated solvent until a 15–milliliter flask with a layer of isooctane. Transfer the portion of the wash shows 0.00 absorbance filtrate to a 2–liter separatory funnel and per centimeter path length between 280 mµ draw off the dimethyl sulfoxide into the 2– and 400 mµ when tested as prescribed under liter distillation flask of the vacuum dis- ‘‘Organic solvents.’’ Usually three portions tillation assembly and distill at approxi- of wash solvent are sufficient. mately 3–millimeter Hg pressure or less. Dis- Before proceeding with analysis of a sam- card the first 200–milliliter fraction of the distillate and replace the distillate collec- ple, determine the absorbance in a 5–centi- µ µ tion flask with a clean one. Continue the dis- meter path cell between 250 m and 400 m tillation until approximately 1 liter of the for the reagent blank by carrying out the sulfoxide has been collected. procedure, without a wax sample, at room At completion of the distillation, the rea- temperature, recording the spectra after the gent should be stored in glass-stoppered bot- extraction stage and after the complete pro- tles since it is very hygroscopic and will cedure as prescribed. The absorbance per react with some metal containers in the centimeter path length following the extrac- presence of air. tion stage should not exceed 0.040 in the Phosphoric acid. 85 percent A.C.S. reagent wavelength range from 280 mµ to 400 mµ; the grade. absorbance per centimeter path length fol- Sodium borohydride. 98 percent. lowing the complete procedure should not Magnesium oxide (Sea Sorb 43, Food Machin- exceed 0.070 in the wavelength range from 280 ery Company, Westvaco Division, distributed by mµ to 299 mµ, inclusive, nor 0.045 in the chemical supply firms, or equivalent). Place 100 wavelength range from 300 mµ to 400 mµ. If in grams of the magnesium oxide in a large either spectrum the characteristic benzene beaker, add 700 milliliters of distilled water peaks in the 250 mµ–260 mµ region are to make a thin slurry, and heat on a steam present, remove the benzene by the proce- bath for 30 minutes with intermittent stir- dure under ‘‘Organic solvents’’ and record ring. Stir well initially to insure that all the absorbance again. absorbent is completely wetted. Using a Place 300 milliliters of dimethyl sulfoxide Buchner funnel and a filter paper (Schleicher in a 1–liter separatory funnel and add 75 mil- & Schuell No. 597, or equivalent) of suitable liliters of phosphoric acid. Mix the contents diameter, filter with suction. Continue suc- of the funnel and allow to stand for 10 min- tion until water no longer drips from the utes. (The reaction between the sulfoxide funnel. Transfer the absorbent to a glass and the acid is exothermic. Release pressure trough lined with aluminum foil (free from after mixing, then keep funnel stoppered.) rolling oil). Break up the magnesia with a Add 150 milliliters of isooctane and shake to clean spatula and spread out the absorbent preequilibrate the solvents. Draw off the in- on the aluminum foil in a layer about 1 cen- dividual layers and store in glass-stoppered timeter to 2 centimeters thick. Dry for 24 hours at 160 °C ±1 °C. Pulverize the magnesia flasks. with mortar and pestle. Sieve the pulverized Place a representative 1–kilogram sample absorbent between 60–180 mesh. Use the mag- of wax, or if this amount is not available, the nesia retained on the 180–mesh sieve. entire sample, in a beaker of a capacity Celite 545. Johns-Manville Company, diato- about three times the volume of the sample maceous earth, or equivalent. and heat with occasional stirring on a steam Magnesium oxide-Celite 545 mixture (2+ 1) by bath until the wax is completely melted and weight. Place the magnesium oxide (60–180 homogeneous. Weigh four 25–gram ±0.2 gram mesh) and the Celite 545 in 2 to 1 propor- portions of the melted wax in separate 100– tions, respectively, by weight in a glass- milliliter beakers. Reserve three of the por- stoppered flask large enough for adequate tions for later replicate analyses as nec- mixing. Shake vigorously for 10 minutes. essary. Pour one weighed portion imme- Transfer the mixture to a glass trough lined diately after remelting (on the steam bath) with aluminum foil (free from rolling oil) into a 500–milliliter separatory funnel con- and spread it out on a layer about 1 centi- taining 100 milliliters of the preequilibrated meter to 2 centimeters thick. Reheat the sulfoxide-phosphoric acid mixture that has mixture at 160 °C ±1 °C for 2 hours, and store been heated in the heating jacket at a tem- in a tightly closed flask. perature just high enough to keep the wax Sodium sulfate, anhydrous, A.C.S. reagent melted. (NOTE: In preheating the sulfoxide- grade, preferably in granular form. For each acid mixture, remove the stopper of the sepa- bottle of sodium sulfate reagent used, estab- ratory funnel at intervals to release the lish as follows the necessary sodium sulfate pressure.)

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Promptly complete the transfer of the liter portion of isooctane, reevaporate to 1 sample to the funnel in the jacket with por- milliliter of hexadecane, and repeat this op- tions of the preequilibrated isooctane, warm- eration once. ing the beaker, if necessary, and using a Quantitatively transfer the residue with total volume of just 50 milliliters of the sol- isooctane to a 25–milliliter volumetric flask, vent. If the wax comes out of solution during make to volume, and mix. Determine the ab- these operations, let the stoppered funnel re- sorbance of the solution in the 5–centimeter main in the jacket until the wax redissolves. path length cells compared to isooctane as (Remove stopper from the funnel at intervals reference between 280 mµ–400 mµ (take care to release pressure.) When the wax is in solu- to lose none of the solution in filling the tion, remove the funnel from the jacket and sample cell). Correct the absorbance values shake it vigorously for 2 minutes. Set up for any absorbance derived from reagents as three 250–milliliter separatory funnels with determined by carrying out the procedure each containing 30 milliliters of without a wax sample. If the corrected ab- preequilibrated isooctane. After separation sorbance does not exceed the limits pre- of the liquid phases, allow to cool until the scribed in this paragraph (b), the wax meets main portion of the wax-isooctane solution the ultraviolet absorbance specifications. If begins to show a precipitate. Gently swirl the corrected absorbance per centimeter the funnel when precipitation first occurs on path length exceeds the limits prescribed in the inside surface of the funnel to accelerate this paragraph (b), proceed as follows: this process. Carefully draw off the lower Quantitatively transfer the isooctane solu- layer, filter it slowly through a thin layer of tion to a 125–milliliter flask equipped with glass wool fitted loosely in a filter funnel into the first 250–milliliter separatory fun- 24/40 joint and evaporate the isooctane on nel, and wash in tandem with the 30–milli- the steam bath under a stream of nitrogen to liter portions of isooctane contained in the a volume of 1 milliliter of hexadecane. Add 250–milliliter separatory funnels. Shaking 10 milliliters of methyl alcohol and approxi- time for each wash is 1 minute. Repeat the mately 0.3 gram of sodium borohydride. extraction operation with two additional (Minimize exposure of the borohydride to the portions of the sulfoxide-acid mixture, re- atmosphere. A measuring dipper may be placing the funnel in the jacket after each used.) Immediately fit a water-cooled con- extraction to keep the wax in solution and denser equipped with a 24/40 joint and with a washing each extractive in tandem through drying tube into the flask, mix until the the same three portions of isooctane. borohydride is dissolved, and allow to stand Collect the successive extractives (300 mil- for 30 minutes at room temperature, with liliters total) in a separatory funnel (pref- intermittent swirling. At the end of this pe- erably 2–liter), containing 480 milliliters of riod, disconnect the flask and evaporate the distilled water, mix, and allow to cool for a methyl alcohol on the steam bath under ni- few minutes after the last extractive has trogen until the sodium borohydride begins been added. Add 80 milliliters of isooctane to to come out of the solution. Then add 10 mil- the solution and extract by shaking the fun- liliters of isooctane and evaporate to a vol- nel vigorously for 2 minutes. Draw off the ume of about 2–3 milliliters. Again, add 10 lower aqueous layer into a second separatory milliliters of isooctane and concentrate to a funnel (preferably 2–liter) and repeat the ex- volume of approximately 5 milliliters. Swirl traction with 80 milliliters of isooctane. the flask repeatedly to assure adequate Draw off and discard the aqueous layer. washing of the sodium borohydride residues. Wash each of the 80–milliliter extractives Fit the tetrafluoroethylene polymer disc three times with 100–milliliter portions of on the upper part of the stem of the distilled water. Shaking time for each wash chromatographic tube, then place the tube is 1 minute. Discard the aqueous layers. Fil- with the disc on the suction flask and apply ter the first extractive through anhydrous the vacuum (approximately 135 millimeters sodium sulfate prewashed with isooctane (see Hg pressure). Weight out 14 grams of the 2:1 Sodium Sulfate under ‘‘Reagents and Mate- magnesium oxide-Celite 545 mixture and rials’’ for preparation of filter) into a 250– pour the adsorbent mixture into the milliliter Erlenmeyer flask (or optionally chromatographic tube in approximately 3– into the evaporation flask). Wash the first centimeter layers. After the addition of each separatory funnel with the second 80–milli- layer, level off the top of the adsorbent with liter isooctane extractive and pass through a flat glass rod or metal plunger by pressing the sodium sulfate. Then wash the second down firmly until the adsorbent is well and first separatory funnels successively packed. Loosen the topmost few millimeters with a 20–milliliter portion of isooctane and of each adsorbent layer with the end of a pass the solvent through the sodium sulfate metal rod before the addition ofthe next into the flask. Add 1 milliliter of n-hexa- layer. Continue packing in this manner until decane and evaporate the isooctane on the all the 14 grams of the adsorbent is added to steam bath under nitrogen. Discontinue the tube. Level off the top of the adsorbent evaporation when not over 1 milliliter of res- by pressing down firmly with a flat glass rod idue remains. To the residue, add a 10–milli- or metal plunger to make the depth of the

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adsorbent bed approximately 12.5 centimeter path length cells compared to iso- meters in depth. Turn off the vacuum and re- octane as reference between 250 mµ–400 mµ. move the suction flask. Fit the 500–milliliter Correct for any absorbance derived from the reservoir onto the top of the reagents as determined by carrying out the chromatographic column and prewet the col- procedure without a wax sample. If either umn by passing 100 milliliters of isooctane spectrum shows the characteristic benzene through the column. Adjust the nitrogen peaks in the 250 mµ–260 mµ region, evaporate pressure so that the rate of descent of the the solution to remove benzene by the proce- isooctane coming off of the column is be- dure under ‘‘Organic Solvents.’’ Dissolve the tween 2–3 milliliters per minute. Discontinue residue, transfer quantitatively, and adjust pressure just before the last of the isooctane to volume in isooctane in a 25–milliliter vol- reaches the level of the adsorbent. (CAUTION: umetric flask. Record the absorbance again. Do not allow the liquid level to recede below If the corrected absorbance does not exceed the adsorbent level at any time.) Remove the the limits prescribed in this paragraph (b), reservoir and decant the 5–milliliter iso- the wax meets the ultraviolet absorbance octane concentrate solution onto the column specifications. and with slight pressure again allow the liquid level to recede to barely above the ad- (c) Petroleum wax may contain one sorbent level. Rapidly complete the transfer or more of the following adjuvants in similarly with two 5–milliliter portions of amounts not greater than that re- isooctane, swirling the flask repeatedly each quired to produce their intended effect: time to assure adequate washing of the res- (1) Antioxidants permitted in food by idue. Just before the final 5–milliliter wash regulations issued in accordance with reaches the top of the adsorbent, add 100 mil- section 409 of the act. liliters of isooctane to the reservoir and con- (2) Poly(alkylacrylate) (CAS Reg. No. tinue the percolation at the 2–3 milliliter per minute rate. Just before the last of the iso- 27029–57–8), made from long chain (C16- octane reaches the adsorbent level, add 100 C22) alcohols and acrylic acid, or milliliters of 10 percent benzene in isooctane poly(alkylmethacrylate) (CAS Reg. No. to the reservoir and continue the percolation 179529–36–3), made from long chain (C18- at the aforementioned rate. Just before the C22) methacrylate esters, having: solvent mixture reaches adsorbent level, add (i) A number average molecular 25 milliliters of 20 percent benzene in iso- weight between 40,000 and 100,000; octane to the reservoir and continue the per- (ii) A weight average molecular colation at 2–3 milliliters per minute until all this solvent mixture has been removed weight (MWw) to number average mo- from the column. Discard all the elution sol- lecular weight (MWn) ratio (MWw/MWn) vents collected up to this point. Add 300 mil- of not less than 3; and liliters of the acetone-benzene-water mixture (iii) Unreacted alkylacrylate or to the reservoir and percolate through the alkylmethacrylate monomer content column to elute the polynuclear compounds. not in excess of 14 percent, as deter- Collect the eluate in a clean 1–liter sepa- mined by a method entitled ‘‘Method ratory funnel. Allow the column to drain for Determining Weight-Average and until most of the solvent mixture is removed. Wash the eluate three times with Number-Average Molecular Weight and 300–milliliter portions of distilled water, for Determining Alkylacrylate Mon- shaking well for each wash. (The addition of omer Content of Poly(alkylacrylate) small amounts of sodium chloride facilitates used as Processing Aid in Manufacture separation.) Discard the aqueous layer after of Petroleum Wax,’’ which is incor- each wash. After the final separation, filter porated by reference in accordance the residual benzene through anhydrous so- with 5 U.S.C. 552(a) and 1 CFR part 51. dium sulfate prewashed with benzene (see So- Copies are available from the Office of dium sulfate under ‘‘Reagents and Materials’’ for preparation of filter) into a 250–milliliter Premarket Approval (HFS–200), Center Erlenmeyer flask (or optionally into the for Food Safety and Applied Nutrition, evaporation flask). Wash the separatory fun- Food and Drug Administration, 5100 nel with two additional 20–milliliter portions Paint Branch Pkwy., College Park, MD of benzene which are also filtered through 20740, or may be examined at the Cen- the sodium sulfate. Add 1 milliliter of n- ter for Food Safety and Applied Nutri- hexadecane and completely remove the ben- tion’s Library, Food and Drug Admin- zene by evaporation under nitrogen, using istration, 5100 Paint Branch Pkwy., the special procedure to eliminate benzene College Park, MD 20740 or at the Office as previously described under ‘‘Organic Sol- vents.’’ Quantitatively transfer the residue of the Federal Register, 800 North Cap- with isooctane to a 25–milliliter volumetric itol St. NW., suite 700, Washington, DC. flask and adjust to volume. Determine the Petroleum wax shall contain not more absorbance of the solution in the 5–centi- than 1,050 parts per million of

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poly(alkylacrylate) or Use Limitations poly(alkylmethacrylate) residues as determined by a method entitled In chewing gum base, as a In accordance with § 172.615 masticatory substance. in an amount not to exceed ‘‘Method for Determining Residual good manufacturing prac- Level of Poly(alkylacrylate) in Petro- tice. leum Wax,’’ which is incorporated by On cheese and raw fruits and In an amount not to exceed vegetables as a protective good manufacturing prac- reference. Copies are available from coating. tice. the addresses cited in this paragraph. As a defoamer in food ...... In accordance with § 173.340 (d) Petroleum wax is used or intended of this chapter. for use as follows: [42 FR 14491, Mar. 15, 1977, as amended at 59 Use Limitations FR 10986, Mar. 9, 1994] In chewing gum base, as a mas- In an amount not to ex- ticatory substance. ceed good manufac- § 172.890 Rice bran wax. turing practice. On cheese and raw fruits and Do. Rice bran wax may be safely used in vegetables as a protective coat- food in accordance with the following ing. conditions: As a defoamer in food ...... In accordance with § 173.340 of this chap- (a) It is the refined wax obtained ter. from rice bran and meets the following As a component of microcapsules In accordance with specifications: for spice-flavoring substances. § 172.230 of this chapter. Melting point 75 °C to 80 °C. Free fatty acids, maximum 10 percent. [42 FR 14491, Mar. 15, 1977, as amended at 45 Iodine number, maximum 20. FR 48123, July 18, 1980; 47 FR 11838, Mar. 19, Saponification number 75 to 120. 1982; 50 FR 32561, Aug. 13, 1985; 51 FR 19544, (b) It is used or intended for use as May 30, 1986; 54 FR 24897, June 12, 1989; 64 FR 44122, Aug. 13, 1999] follows:

Food Limitation in food Use § 172.888 Synthetic petroleum wax. Synthetic petroleum wax may be Candy ...... 50 p.p.m ...... Coating. Fresh fruits and fresh ...... do ...... Do. safely used in or on foods in accordance vegetables. with the following conditions: Chewing gum ...... 21⁄2 pct ...... Plasticizing (a) Synthetic petroleum wax is a material. mixture of solid hydrocarbons, paraffinic in nature, prepared by either § 172.892 Food starch-modified. catalytic polymerization of ethylene or Food starch-modified as described in copolymerization of ethylene with lin- this section may be safely used in food. ear (C3 to C12) alpha-olefins, and refined to meet the specifications prescribed in The quantity of any substance em- this section. ployed to effect such modification shall (b) Synthetic petroleum wax meets not exceed the amount reasonably re- the ultraviolet absorbance limits of quired to accomplish the intended § 172.886(b) when subjected to the ana- physical or technical effect, nor exceed lytical procedure described therein. any limitation prescribed. To insure (c) Synthetic petroleum wax has a safe use of the food starch-modified, number average molecular weight of the label of the food additive container not less than 500 nor greater than 1,200 shall bear the name of the additive as determined by vapor pressure os- ‘‘food starch-modified’’ in addition to mometry. other information required by the Act. (d) Synthetic petroleum wax may Food starch may be modified by treat- contain any antioxidant permitted in ment prescribed as follows: food by regulations issued in accord- (a) Food starch may be acid-modified ance with section 409 of the act, in an by treatment with hydrochloric acid or amount not greater than that required sulfuric acid or both. to produce its intended effect. (b) Food starch may be bleached by (e) Synthetic petroleum wax is used treatment with one or more of the fol- or intended for use as follows: lowing:

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Limitations Limitations

Active oxygen obtained from hy- Sodium tripolyphosphate and so- Residual phosphate in drogen peroxide and/or per- dium trimetaphosphate. food starch-modified acetic acid, not to exceed 0.45 not to exceed 0.4 per- percent of active oxygen. cent calculated as Ammonium persulfate, not to ex- phosphorus. ceed 0.075 percent and sulfur Succinic anhydride, not to exceed dioxide, not to exceed 0.05 per- 4 percent. cent. Vinyl acetate ...... Acetyl groups in food Chlorine, as calcium hypochlorite, The finished food starch- starch-modified not to not to exceed 0.036 percent of modified is limited to exceed 2.5 percent. dry starch. use only as a component of batter for com- (e) Food starch may be etherified by mercially processed foods. treatment with one of the following: Chlorine, as sodium hypochlorite, not to exceed 0.0082 pound of Limitations chlorine per pound of dry starch. Potassium permanganate, not to Residual manganese Acrolein, not to exceed 0.6 per- exceed 0.2 percent. (calculated as Mn), not cent. to exceed 50 parts per Epichlorohydrin, not to exceed million in food starch- 0.3 percent. modified. Epichlorohydrin, not to exceed Residual propylene Sodium chlorite, not to exceed 0.5 0.1 percent, and propylene chlorohydrin not more percent. oxide, not to exceed 10 per- than 5 parts per million cent, added in combination or in food starch-modified. in any sequence. (c) Food starch may be oxidized by Epichlorohydrin, not to exceed Do. treatment with chlorine, as sodium hy- 0.1 percent, followed by pro- pochlorite, not to exceed 0.055 pound of pylene oxide, not to exceed 25 chlorine per pound of dry starch. percent. Propylene oxide, not to exceed Do. (d) Food starch may be esterified by 25 percent. treatment with one of the following: (f) Food starch may be esterified and Limitations etherified by treatment with one of the Acetic anhydride ...... Acetyl groups in food following: starch-modified not to exceed 2.5 percent. Limitations Adipic anhydride, not to exceed Do. 0.12 percent, and acetic anhy- Acrolein, not to exceed 0.6 per- Acetyl groups in food dride. cent and vinyl acetate, not to starch-modified not to Monosodium orthophosphate ...... Residual phosphate in exceed 7.5 percent. exceed 2.5 percent. food starch-modified Epichlorohydrin, not to exceed 0.3 Acetyl groups in food not to exceed 0.4 per- percent, and acetic anhydride. starch-modified not to cent calculated as exceed 2.5 percent. phosphorus. Epichlorohydrin, not to exceed 0.3 1–Octenyl succinic anhydride, not percent, and succinic anhy- to exceed 3 percent. dride, not to exceed 4 percent. 1–Octenyl succinic anhydride, not Phosphorus oxychloride, not to Residual propylene to exceed 2 percent, and alu- exceed 0.1 percent, and pro- chlorohydrin not more minum sulfate, not to exceed 2 pylene oxide, not to exceed 10 than 5 parts per million percent. percent. in food starch-modi- 1-Octenyl succinic anhydride, not Limited to use as a sta- fied. to exceed 3 percent, followed bilizer or emulsifier in by treatment with a beta-amy- beverages and bev- (g) Food starch may be modified by lase enzyme that is either an erage bases as de- approved food additive of is fined in § 170.3(n)(3) of treatment with one of the following: generally recognized as safe. this chapter. Phosphorus oxychloride, not to Limitations exceed 0.1 percent. Phosphorus oxychloride, not to Acetyl groups in food Chlorine, as sodium hypochlorite, Residual propylene exceed 0.1 percent, followed by starch-modified not to not to exceed 0.055 pound of chlorohydrin not more either acetic anhydride, not to exceed 2.5 percent. chlorine per pound of dry than 5 parts per million exceed 8 percent, or vinyl ace- starch; 0.45 percent of active in food starch-modi- tate, not to exceed 7.5 percent. oxygen obtained from hydrogen fied. peroxide; and propylene oxide, Sodium trimetaphosphate ...... Residual phosphate in not to exceed 25 percent. food starch-modified not to exceed 0.04 Sodium hydroxide, not to exceed percent, calculated as 1 percent. phosphorus.

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(h) Food starch may be modified by a (2) It contains no added arsenic com- combination of the treatments pre- pound and therefore may not exceed a scribed by paragraphs (a), (b), and/or (i) maximum natural background level of of this section and any one of the 0.2 part per million total arsenic, cal- treatments prescribed by paragraph (c), culated as As. (d), (e), (f), or (g) of this section, sub- (c) To assure safe use of the additive, ject to any limitations prescribed by the label of the food additive container the paragraphs named. shall bear, in addition to other infor- (i) Food starch may be modified by mation required by the act, the name treatment with the following enzymes: of the additive as follows: (1) The additive identified in para- Enzyme Limitations graph (a)(1) of this section as ‘‘par- Alpha-amylase (E.C. 3.2.1.1) ...... The enzyme must be tially defatted, cooked cottonseed generally recognized flour’’. as safe or approved as (2) The additive identified in para- a food additive for this purpose. The resulting graph (a)(2) of this section as ‘‘defatted nonsweet nutritive sac- cottonseed flour’’. charide polymer has a (3) The additive identified in para- dextrose equivalent of less than 20. graph (a)(3) of this section as ‘‘roasted Beta-amylase (E.C. 3.2.1.2) ...... glandless cottonseed kernels’’. Glucoamylase (E.C. 3.2.1.3) ...... (4) The additive identified in para- Isoamylase (E.C. 3.2.1.68) ...... graph (a)(4) of this section as ‘‘raw Pullulanase (E.C. 3.2.1.41) ...... glandless cottonseed kernels for use in cooked hard candy’’. [42 FR 14491, Mar. 15, 1977, as amended at 43 (d) The Food and Drug Administra- FR 11697, Mar. 21, 1978; 46 FR 32015, June 19, 1981; 57 FR 54700, Nov. 20, 1992; 58 FR 21100, tion and the Environmental Protection Apr. 19, 1993; 66 FR 17509, Apr. 2, 2001] Agency have determined that glandless cottonseed kernels permitted for use § 172.894 Modified cottonseed products by this section are a distinct com- intended for human consumption. modity from glanded cottonseed. The food additive modified cottonseed products may be used for human § 172.896 Dried yeasts. consumption in accordance with the Dried yeast (Saccharomyces cerevisiae following prescribed conditions: and Saccharomyces fragilis) and dried (a) The additive is derived from: torula yeast (Candida utilis) may be (1) Decorticated, partially defatted, safely used in food provided the total cooked, ground cottonseed kernels; or folic acid content of the yeast does not (2) Decorticated, ground cottonseed exceed 0.04 milligram per gram of yeast kernels, in a process that utilizes n- (approximately 0.008 milligram of hexane as an extracting solvent in such pteroyglutamic acid per gram of a way that no more than 60 parts per yeast). million of n-hexane residues and less than 1 percent fat by weight remain in § 172.898 Bakers yeast glycan. the finished product; or Bakers yeast glycan may be safely (3) Glandless cottonseed kernels used in food in accordance with the fol- roasted to attain a temperature of not lowing conditions: less than 250 °F in the kernel for not (a) Bakers yeast glycan is the less than 5 minutes for use as a snack comminuted, washed, pasteurized, and food, or in baked goods, or in soft dried cell walls of the yeast, Saccharo- candy; or myces cerevisiae. It is composed prin- (4) Raw glandless cottonseed kernels cipally of long chain carbohydrates, may be used in hard candy where the not less than 85 percent on a dry solids kernel temperature during cooking basis. The carbohydrate is composed of will exceed 250 °F for not less than 5 glycan and mannan units in approxi- minutes. mately a 2:1 ratio. (b) The additive is prepared to meet (b) The additive meets the following the following specifications: specifications on a dry weight basis: (1) Free gossypol content not to ex- Less than 0.4 part per million (ppm) ar- ceed 450 parts per million. senic, 0.13 ppm cadmium, 0.2 ppm lead,

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0.05 ppm mercury, 0.09 ppm selenium, PART 173—SECONDARY DIRECT and 10 ppm zinc. FOOD ADDITIVES PERMITTED IN (c) The viable microbial content of FOOD FOR HUMAN CONSUMP- the finished ingredient is: TION (1) Less than 10,000 organisms/gram by aerobic plate count. Subpart A—Polymer Substances and (2) Less than 10 yeasts and molds/ Polymer Adjuvants for Food Treatment gram. Sec. (3) Negative for Salmonella, E. coli, 173.5 Acrylate-acrylamide resins. coagulase positive Staphylococci, Clos- 173.10 Modified polyacrylamide resin. tridium perfringens, Clostridium botu- 173.20 Ion-exchange membranes. linum, or any other recognized micro- 173.21 Perfluorinated ion exchange mem- bial pathogen or any harmful microbial branes. 173.25 Ion-exchange resins. toxin. 173.40 Molecular sieve resins. (d) The additive is used or intended 173.45 Polymaleic acid and its sodium salt. for use in the following foods when 173.50 Polyvinylpolypyrrolidone. standards of identity established under 173.55 Polyvinylpyrrolidone. section 401 of the Act do not preclude 173.60 Dimethylamine-epichlorohydrin copolymer. such use: 173.65 Divinylbenzene copolymer. 173.70 Chloromethylated aminated styrene- Use Limitations divinylbenzene resin. (1) In salad dressings as an emul- Not to exceed a con- 173.73 Sodium polyacrylate. sifier and emulsifier salt as de- centration of 5 percent 173.75 Sorbitan monooleate. fined in § 170.3(o)(8) of this of the finished salad chapter, stabilizer and thickener dressing. Subpart B—Enzyme Preparations and as defined in § 170.3(o)(28) of Microorganisms this chapter, or texturizer as defined in § 170.3(o)(32) of this 173.110 Amyloglucosidase derived from chapter. Rhizopus niveus. (2) In frozen dessert analogs as a In an amount not to ex- 173.115 Alpha-acetolactate decarboxylase ( - stabilizer and thickener as de- ceed good manufac- a fined in § 170.3(o)(28) of this turing practice. ALDC) enzyme preparation derived from chapter, or texturizer as defined a recombinant Bacillus subtilis. in § 170.3(o)(32) of this chapter. 173.120 Carbohydrase and cellulase derived (3) In sour cream analogs as a Do. from Aspergillus niger. stabilizer and thickener as de- 173.130 Carbohydrase derived from Rhizopus fined in § 170.3(o)(28) of this oryzae. chapter, or texturizer as defined 173.135 Catalase derived from Microccocus in § 170.3(o)(32) of this chapter. lysodeikticus. (4) In cheese spread analogs as Do. 173.140 Esterase-lipase derived from Mucor a stabilizer and thickener as defined in § 170.3(o)(28) of this miehei. chapter, or texturizer as defined 173.145 Alpha-Galactosidase derived from in § 170.3(o)(32) of this chapter. Mortierella vinaceae var. raffinoseutilizer. (5) In cheese-flavored and sour Do. 173.150 Milk-clotting enzymes, microbial. cream-flavored snack dips as a 173.160 Candida guilliermondii. stabilizer and thickener as de- 173.165 Candida lipolytica. fined in § 170.3(o)(28) of this 173.170 Aminoglycoside 3′- chapter, or texturizer as defined phosphotransferase II. in § 170.3(o)(32) of this chapter. Subpart C—Solvents, Lubricants, Release (e) The label and labeling of the in- Agents and Related Substances gredient shall bear adequate directions to assure that use of the ingredient 173.210 Acetone. complies with this regulation. 173.220 1,3–Butylene glycol. 173.228 Ethyl acetate. [42 FR 14491, Mar. 15, 1977, as amended at 45 173.230 Ethylene dichloride. FR 58836, Sept. 5, 1980] 173.240 Isopropyl alcohol. 173.250 Methyl alcohol residues. 173.255 Methylene chloride. 173.270 Hexane. 173.275 Hydrogenated sperm oil. 173.280 Solvent extraction process for citric acid. 173.290 Trichloroethylene.

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Subpart D—Specific Usage Additives (b) The additive contains not more than 0.05 percent of residual monomer 173.300 Chlorine dioxide. calculated as acrylamide. 173.310 Boiler water additives. 173.315 Chemicals used in washing or to as- (c) The additive is used or intended sist in the peeling of fruits and vegeta- for use as follows: bles. (1) The additive identified in para- 173.320 Chemicals for controlling micro- graph (a) (1) of this section is used as a organisms in cane-sugar and beet-sugar flocculent in the clarification of beet mills. sugar juice and liquor or cane sugar 173.322 Chemicals used in delinting cotton- juice and liquor or corn starch seed. 173.325 Acidified sodium chlorite solutions. hydrolyzate in an amount not to ex- 173.340 Defoaming agents. ceed 5 parts per million by weight of 173.342 Chlorofluorocarbon 113 and the juice or 10 parts per million by perfluorohexane. weight of the liquor or the corn starch 173.345 Chloropentafluoroethane. hydrolyzate. 173.350 Combustion product gas. (2) The additive identified in para- 173.355 Dichlorodifluoromethane. graph (a)(2) of this section is used to 173.357 Materials used as fixing agents in control organic and mineral scale in the immobilization of enzyme preparations. beet sugar juice and liquor or cane 173.360 Octafluorocyclobutane. sugar juice and liquor in an amount 173.368 Ozone. not to exceed 2.5 parts per million by 173.370 Peroxyacids. weight of the juice or liquor. 173.385 Sodium methyl sulfate. 173.395 Trifluoromethane sulfonic acid. [42 FR 14526, Mar. 15, 1977, as amended at 46 173.400 Dimethyldialkylammonium chlo- FR 30494, June 9, 1981] ride. § 173.10 Modified polyacrylamide AUTHORITY: 21 U.S.C. 321, 342, 348. resin. SOURCE: 42 FR 14526, Mar. 15, 1977, unless Modified polyacrylamide resin may otherwise noted. be safely used in food in accordance EDITORIAL NOTE: Nomenclature changes to with the following prescribed condi- part 173 appear at 61 FR 14482, Apr. 2, 1996, 66 tions: FR 56035, Nov. 6, 2001, and 66 FR 66742, Dec. (a) The modified polyacrylamide 27, 2001. resin is produced by the copolymerization of acrylamide with not more than Subpart A—Polymer Substances 5–mole percent b-methacrylyloxyethy- and Polymer Adjuvants for ltrimethylammonium methyl sulfate. Food Treatment (b) The modified polyacrylamide resin contains not more than 0.05 per- § 173.5 Acrylate-acrylamide resins. cent residual acrylamide. Acrylate-acrylamide resins may be (c) The modified polyacrylamide safely used in food under the following resin is used as a flocculent in the clar- prescribed conditions: ification of beet or cane sugar juice in (a) The additive consists of one of the an amount not exceeding 5 parts per following: million by weight of the juice. (1) Acrylamide-acrylic acid resin (d) To assure safe use of the additive, (hydrolyzed polyacrylamide) is pro- the label and labeling of the additive duced by the polymerization of acryl- shall bear, in addition to the other in- amide with partial hydrolysis, or by formation required by the act, ade- copolymerization of acrylamide and quate directions to assure use in com- acrylic acid, with the greater part of pliance with paragraph (c) of this sec- the polymer being composed of acryl- tion. amide units. (2) Sodium polyacrylate-acrylamide § 173.20 Ion-exchange membranes. resin is produced by the polymerization Ion-exchange membranes may be and subsequent hydrolysis of acrylo- safely used in the processing of food nitrile in a sodium silicate-sodium hy- under the following prescribed condi- droxide aqueous solution, with the tions: greater part of the polymer being com- (a) The ion-exchange membrane is posed of acrylate units. prepared by subjecting a polyethylene

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base conforming to § 177.1520 of this may include substances used in accord- chapter to polymerization with styrene ance with § 174.5 of this chapter. until the polystyrene phase of the base (c) Conditions of use. (1) is not less than 16 percent nor more Perfluorinated ion exchange mem- than 30 percent by weight. The base is branes described in paragraph (a) of then modified by reaction with this section may be used in contact chloromethyl methyl ether, and by with all types of liquid foods at tem- subsequent amination with trimethyl- peratures not exceeding 70° (158 °F). amine, dimethylamine, diethylene- (2) Maximum thickness of the copoly- triamine, or dimethylethanolamine. mer membrane is 0.007 inch (0.017 centi- (b) The ion-exchange membrane is meter). manufactured so as to comply with the (3) Perfluorinated ion exchange mem- following extraction limitations when branes shall be maintained in a sani- subjected to the described procedure: tary manner in accordance with cur- Separate square-foot samples of mem- rent good manufacturing practice so as brane weighing approximately 14 grams to prevent microbial adulteration of food. each are cut into small pieces and (4) To assure their safe use, refluxed for 4 hours in 150 cubic centi- perfluorinated ionomer membranes meters of the following solvents: Dis- shall be thoroughly cleaned prior to tilled water, 5 percent acetic acid, and their first use in accordance with cur- 50 percent alcohol. Extraction from rent good manufacturing practice. each sample will not exceed 0.4 percent by weight of sample. [59 FR 15623, Apr. 4, 1994] (c) The ion-exchange membrane will § 173.25 Ion-exchange resins. be used in the production of grapefruit juice to adjust the ratio of citric acid Ion-exchange resins may be safely to total solids of the grapefruit juice used in the treatment of food under the produced. following prescribed conditions: (a) The ion-exchange resins are pre- § 173.21 Perfluorinated ion exchange pared in appropriate physical form, and membranes. consist of one or more of the following: (1) Sulfonated copolymer of styrene Substances identified in paragraph and divinylbenzene. (a) of this section may be safely used as (2) Sulfonated anthracite coal meet- ion exchange membranes intended for ing the requirements of ASTM method use in the treatment of bulk quantities D388–38, Class I, Group 2, ‘‘Standard of liquid food under the following pre- Specifications for Classification of Coal scribed conditions: by Rank,’’ which is incorporated by (a) Identity. The membrane is a co- reference. Copies are available from polymer of ethanesulfonyl fluoride, 2- University Microfilms International, [1-[difluoro-[(trifluoro- 300 N. Zeeb Rd., Ann Arbor, MI 48106, or ethenyl)oxy]methyl]-1,2,2,2-tetrafluoro- available for inspection at the Office of ethoxy]-1,1,2,2,-tetrafluoro-, with tetra- the Federal Register, 800 North Capitol fluoroethylene that has been subse- Street, NW., suite 700, Washington, DC quently treated to hydrolyze the 20408. sulfonyl fluoride group to the sulfonic (3) Sulfite-modified cross-linked phe- acid. The Chemical Abstracts Service nol-formaldehyde, with modification name of this polymer is ethanesulfonic resulting in sulfonic acid groups on acid, 2-[1-[difluoro-[(trifluoro- side chains. ethenyl)oxy]methyl]-1,2,2,2-tetrafluoro- (4) Methacrylic acid-divinylbenzene ethoxy]-1,1,2,2,-tetrafluoro-, polymer copolymer. with tetrafluoroethane (CAS Reg. No. (5) Cross-linked polystyrene, first 31175–20–9). chloromethylated then aminated with (b) Optional adjuvant substances. The trimethylamine, dimethylamine, dibasic polymer identified in paragraph ethylenetriamine, or dimethylethanol- (a) of this section may contain optional amine. adjuvant substances required in the (6) Diethylenetriamine, triethylene- production of such basic polymer. tetramine, or tetraethylenepentamine These optional adjuvant substances cross-linked with epichlorohydrin.

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(7) Cross-linked phenol-formaldehyde (19) Epichlorohydrin cross-linked activated with one or both of the fol- with ammonia and then quaternized lowing: Triethylene tetramine and with methyl chloride to contain not tetraethylenepentamine. more than 18 percent strong base ca- (8) Reaction resin of formaldehyde, pacity by weight of total exchange ca- acetone, and tetraethylenepentamine. pacity [Chemical Abstracts Service (9) Completely hydrolyzed copoly- name: Oxirane (chloromethyl)-, polymers of methyl acrylate and mer with ammonia, reaction product divinylbenzene. with chloromethane; CAS Reg. No. (10) Completely hydrolyzed 68036–99–7]. terpolymers of methyl acrylate, (20) Regenerated cellulose, cross- divinylbenzene, and acrylonitrile. linked and alkylated with epichloro- (11) Sulfonated terpolymers of sty- hydrin and propylene oxide, then sulfo- rene, divinylbenzene, and acrylonitrile nated whereby the amount of epi- or methyl acrylate. chlorohydrin plus propylene oxide em- (12) Methyl acrylate-divinylbenzene ployed does not exceed 250 percent by copolymer containing not less than 2 weight of the starting quantity of cel- percent by weight of divinylbenzene, lulose. aminolyzed with dimethylaminopro- (b) Ion-exchange resins are used in pylamine. the purification of foods, including po- (13) Methyl acrylate-divinylbenzene table water, to remove undesirable ions copolymer containing not less than 3.5 or to replace less desirable ions with percent by weight of divinylbenzene, one or more of the following: bicarbon- aminolyzed with dimethylaminopro- ate, calcium, carbonate, chloride, hy- pylamine. drogen, hydroxyl, magnesium, potas- (14) Epichlorohydrin cross-linked sium, sodium, and sulfate except that: with ammonia. The ion-exchange resin identified in (15) Sulfonated tetrapolymer of sty- paragraph (a)(12) of this section is used rene, divinylbenzene, acrylonitrile, and only in accordance with paragraph methyl acrylate derived from a mix- (b)(1) of this section, the ion-exchange ture of monomers containing not more resin identified in paragraph (a)(13) of than a total of 2 percent by weight of acrylonitrile and methyl acrylate. this section is used only in accordance (16) Methyl acrylate-divinylbenzene- with paragraph (b)(2) of this section, diethylene glycol divinyl ether the resin identified in paragraph (a)(16) terpolymer containing not less than 3.5 of this section is used only in accord- percent by weight of divinylbenzene ance with paragraph (b)(1) or (b)(2) of and not more than 0.6 percent by this section, the ion-exchange resin weight of diethylene glycol divinyl identified in paragraph (a)(17) of this ether, aminolyzed with dimethyl- section is used only in accordance with aminopropylamine. paragraph (b)(3) of this section, the (17) Styrene-divinylbenzene cross- ion-exchange resin identified in para- linked copolymer, first graph (a)(18) of this section is used only chloromethylated then aminated with in accordance with paragraph (b)(4) of dimethylamine and oxidized with hy- this section, and the ion-exchange drogen peroxide whereby the resin con- resin identified in paragraph (a)(20) of tains not more than 15 percent by this section is used only in accordance weight of vinyl N,N-dimethylbenzyl- with paragraphs (b)(5) and (d) of this amine-N-oxide and not more than 6.5 section. percent by weight of nitrogen. (1) The ion-exchange resins identified (18) Methyl acrylate-divinylbenzene- in paragraphs (a) (12) and (16) of this diethylene glycol divinyl ether section are used to treat water for use terpolymer containing not less than 7 in the manufacture of distilled alco- percent by weight of divinylbenzene holic beverages, subject to the fol- and not more than 2.3 percent by lowing conditions: weight of diethylene glycol divinyl (i) The water is subjected to treat- ether, aminolyzed with dimethyl- ment through a mixed bed consisting of aminopropylamine and quaternized one of the resins identified in para- with methyl chloride. graph (a) (12) or (16) of this section and

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one of the strongly acidic cation-ex- only of the types identified under cat- change resins in the hydrogen form egories I, II, and VI–B in Table 1 of identified in paragraphs (a) (1), (2), and § 176.170(c) of this chapter, Provided, (11) of this section; or that either: (ii) The water is first subjected to (A) The temperature of the water or one of the resins identified in para- food passing through the resin bed is graph (a) (12) or (16) of this section and maintained at 50 °C or less and the flow is subsequently subjected to treatment rate of the water or food passing through a bed of activated carbon or through the bed is not less than 0.5 gal- one of the strongly acidic cation-ex- lon per cubic foot per minute; or change resins in the hydrogen form (B) Extracts of the resin will be found identified in paragraphs (a) (1), (2), and to contain no more than 1 milligram/ (11) of this section. kilogram dimethylaminopropylamine (iii) The temperature of the water in each of the food simulants, distilled passing through the resin beds identi- water and 10 percent ethanol, when, fied in paragraphs (b)(1) (i) and (ii) of following washing and pretreatment of this section is maintained at 30 °C or the resin in accordance with less, and the flow rate of the water § 173.25(c)(1), the resin is subjected to passing through the beds is not less the following test under conditions than 2 gallons per cubic foot per simulating the actual temperature and minute. flow rate of use: ‘‘The Determination of (iv) The ion-exchange resins identi- 3-Dimethylaminopropylamine in Food fied in paragraph (a) (12) or (16) of this Simulating Extracts of Ion Exchange section are exempted from the require- Resins,’’ February 4, 1998, which is in- ments of paragraph (c)(4) of this sec- corporated by reference in accordance tion, but the strongly acidic cation-ex- with 5 U.S.C. 552(a) and 1 CFR part 51. change resins referred to in paragraphs Copies are available from the Division (b)(1) (i) and (ii) of this section used in of Petition Control (HFS–215), Center the process meet the requirements of for Food Safety and Applied Nutrition, paragraph (c)(4) of this section, except Food and Drug Administration, 5100 for the exemption described in para- Paint Branch Pkwy., College Park, MD graph (d) of this section. 20740, or may be examined at the Cen- (2) The ion-exchange resins identified ter for Food Safety and Applied Nutri- in paragraphs (a) (13) and (16) of this tion’s Library, 5100 Paint Branch section are used to treat water and Pkwy., College Park, MD 20740, or at aqueous food only of the types identi- the Office of the Federal Register, 800 fied under Categories I, II, and VI–B in North Capitol St. NW., suite 700, Wash- table 1 of § 176.170(c) of this chapter: ington, DC. Provided, That the temperature of the (3) The ion-exchange resin identified water or food passing through the resin in paragraph (a)(17) of this section is beds is maintained at 50 °C or less and used only for industrial application to the flow rate of the water or food pass- treat bulk quantities of aqueous food, ing through the beds is not less than 0.5 including potable water, or for treat- gallon per cubic foot per minute. ment of municipal water supplies, sub- (i) The ion-exchange resin identified ject to the condition that the tempera- in paragraph (a)(13) of this section is ture of the food or water passing used to treat water and aqueous food through the resin bed is maintained at only of the types identified under cat- 25 °C or less and the flow rate of the egories I, II, and VI–B in Table 1 of food or water passing through the bed § 176.170(c) of this chapter: Provided, is not less than 2 gallons per cubic foot That the temperature of the water or per minute. food passing through the resin bed is (4) The ion-exchange resin identified maintained at 50 °C or less and the flow in paragraph (a)(18) of this section is rate of the water or food passing used to treat aqueous sugar solutions through the bed is not less than 0.5 gal- subject to the condition that the tem- lon per cubic foot per minute. perature of the sugar solution passing (ii) The ion-exchange resin identified through the resin bed is maintained at in paragraph (a)(16) of this section is 82 °C (179.6 °F) or less and the flow rate used to treat water and aqueous food of the sugar solution passing through

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the bed is not less than 46.8 liters per tilled water, 15 percent (by volume) cubic meter (0.35 gallon per cubic foot) ethyl alcohol, and 5 percent (by weight) of resin bed volume per minute. acetic acid. The first liter of effluent (5) The ion-exchange resin identified from each solvent is discarded, then in paragraph (a)(20) of this section is the next 2 liters are used to determine limited to use in aqueous process organic extractives. The 2-liter sample streams for the isolation and purifi- is carefully evaporated to constant cation of protein concentrates and iso- weight at 105 °C; this is total extrac- lates under the following conditions: tives. This residue is fired in a muffle (i) For resins that comply with the furnace at 850 °C to constant weight; requirements in paragraph (d)(2)(i) of this is ash. Total extractives, minus this section, the pH range for the resin ash equals the organic extractives. If shall be no less than 3.5 and no more the organic extractives are greater than 9, and the temperatures of water than 1 part per million of the solvent and food passing through the resin bed used, a blank should be run on the sol- shall not exceed 25 °C. vent and a correction should be made (ii) For resins that comply with the by subtracting the total extractives ob- requirements in paragraph (d)(2)(ii) of this section, the pH range for the resin tained with the blank from the total shall be no less than 2 and no more extractives obtained in the resin test. than 10, and the temperatures of water The solvents used are to be made as and food passing through the resin follows: shall not exceed 50 °C. Distilled water (de-ionized water is distilled). (c) To insure safe use of ion-exchange 15 percent ethyl alcohol made by mixing 15 resins, each ion-exchange resin will be: volumes of absolute ethyl alcohol A.C.S. (1) Subjected to pre-use treatment by reagent grade, with 85 volumes of distilled the manufacturer and/or the user in ac- de-ionized water. cordance with the manufacturer’s di- 5 percent acetic acid made by mixing 5 parts rections prescribed on the label or la- by weight of A.C.S. reagent grade glacial beling accompanying the resins, to acetic acid with 95 parts by weight of dis- guarantee a food-grade purity of ion- tilled de-ionized water. exchange resins, in accordance with In addition to the organic extractives good manufacturing practice. limitation prescribed in this para- (2) Accompanied by label or labeling graph, the ion-exchange resin identi- to include directions for use consistent fied in paragraph (a)(17) of this section, with the intended functional purpose of when extracted with each of the named the resin. solvents, distilled water, 50 percent al- (3) Used in compliance with the label cohol, and 5 percent acetic acid, will be or labeling required by paragraph (c)(2) of this section. found to result in not more than 7 (4) Found to result in no more than 1 parts per million of nitrogen extrac- part per million of organic extractives tives (calculated as nitrogen) when the obtained with each of the named sol- resin in the free-base form is subjected vents, distilled water, 15 percent alco- to the following test immediately be- hol, and 5 percent acetic acid when, fore each use: Using a separate 1–inch having been washed and otherwise diameter glass ion-exchange column treated in accordance with the manu- for each solvent, prepare each column facturer’s directions for preparing using 100 milliliters of ready to use ion- them for use with food, the ion-ex- exchange resin that is to be tested. change resin is subjected to the fol- With the bottom outlet closed, fill each lowing test: Using a separate ion-ex- ion-exchange column with one of the change column for each solvent, pre- three solvents at a temperature of 25 °C pare columns using 50 milliliters of the until the solvent level is even with the ready to use ion-exchange resin that is top of the resin bed. Seal each column to be tested. While maintaining the at the top and bottom and store in a highest temperature that will be en- vertical position at a temperature of 25 countered in use pass through these °C. After 96 hours, open the top of each beds at the rate of 350–450 milliliters column, drain the solvent into a collec- per hour the three test solvents dis- tion vessel, and analyze each drained

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solvent and a solvent blank for nitro- prior to their first use in contact with gen by a standard micro-Kjeldahl food. method. (c) Molecular sieve resins are used as (d)(1) The ion-exchange resins identi- the gel filtration media in the final pu- fied in paragraphs (a)(1), (a)(2), (a)(11), rification of partially delactosed whey. and (a)(15) of this section are exempted The gel bed shall be maintained in a from the acetic acid extraction re- sanitary manner in accordance with quirement of paragraph (c)(4) of this good manufacturing practice so as to section. prevent microbial build-up on the bed (2) The ion-exchange resin identified and adulteration of the product. in paragraph (a)(20) of this section shall comply either with: § 173.45 Polymaleic acid and its so- (i) The extraction requirement in dium salt. paragraph (c)(4) of this section by using Polymaleic acid (CAS Reg. No. 26099– dilute sulfuric acid, pH 3.5 as a sub- 09–2) and its sodium salt (CAS Reg. No. stitute for acetic acid; or 70247–90–4) may be safely used in food (ii) The extraction requirement in in accordance with the following pre- paragraph (c)(4) of this section by using scribed conditions: reagent grade hydrochloric acid, diluted to pH 2, as a substitute for acetic (a) The additives have a weight-aver- acid. The resin shall be found to result age molecular weight in the range of in no more than 25 parts per million of 540 to 850 and a number-average molec- organic extractives obtained with each ular weight in the range of 520 to 650, of the following solvents: Distilled calculated as the acid. Molecular water; 15 percent alcohol; and hydro- weights shall be determined by a meth- chloric acid, pH 2. Blanks should be run od entitled ‘‘Determination of Molec- for each of the solvents, and correc- ular Weight Distribution of tions should be made by subtracting Poly(Maleic) Acid,’’ March 17, 1992, pro- the total extractives obtained with the duced by Ciba-Geigy, Inc., Seven Sky- blank from the total extractives ob- line Dr., Hawthorne, NY 10532–2188, tained in the resin test. which is incorporated by reference in (e) Acrylonitrile copolymers identi- accordance with 5 U.S.C. 552(a) and 1 fied in this section shall comply with CFR part 51. Copies are available from the provisions of § 180.22 of this chap- the Division of Product Policy, Center ter. for Food Safety and Applied Nutrition [42 FR 14526, Mar. 15, 1977, as amended at 46 (HFS–205), Food and Drug Administra- FR 40181, Aug. 7, 1981; 46 FR 57033, Nov. 20, tion, 5100 Paint Branch Pkwy., College 1981; 49 FR 28830, July 17, 1984; 56 FR 16268, Park, MD 20740, or are available for in- Apr. 22, 1991; 62 FR 7679, Feb. 20, 1997; 64 FR spection at the Center for Food Safety 14609, Mar. 26, 1999; 64 FR 56173, Oct. 18, 1999] and Applied Nutrition’s Library, 5100 Paint Branch Pkwy., College Park, MD § 173.40 Molecular sieve resins. 20740, or at the Office of the Federal Molecular sieve resins may be safely Register, 800 North Capitol St. NW., used in the processing of food under the suite 700, Washington, DC. following prescribed conditions: (b) The additives may be used, indi- (a) The molecular sieve resins consist vidually or together, in the processing of purified dextran having an average of beet sugar juice and liquor or of cane molecular weight of 40,000, cross-linked sugar juice and liquor to control min- with epichlorohydrin in a ratio of 1 eral scale. part of dextran to 10 parts of (c) The additives are to be used so epichlorohydrin, to give a stable three that the amount of either or both addi- dimensional structure. The resins have tives does not exceed 4 parts per mil- a pore size of 2.0 to 3.0 milliliters per gram of dry resin (expressed in terms lion (calculated as the acid) by weight of water regain), and a particle size of of the beet or cane sugar juice or liquor 10 to 300 microns. process stream. (b) The molecular sieve resins are [51 FR 5315, Feb. 13, 1986, as amended at 61 thoroughly washed with potable water FR 386, Jan. 5, 1996]

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§ 173.50 Polyvinylpolypyrrolidone. § 173.55 Polyvinylpyrrolidone. The food additive polyvinylpoly- The food additive polyvinylpyrroli- pyrrolidone may be safely used in ac- done may be safely used in accordance cordance with the following prescribed with the following prescribed condi- conditions: tions: (a) The additive is a homopolymer of (a) The additive is a polymer of puri- purified vinylpyrrolidone catalytically fied vinylpyrrolidone catalytically pro- produced under conditions producing duced, having an average molecular polymerization and cross-linking such that an insoluble polymer is produced. weight of 40,000 and a maximum (b) The food additive is so processed unsaturation of 1 percent, calculated as that when the finished polymer is the monomer, except that the refluxed for 3 hours with water, 5 per- polyvinylpyrrolidone used in beer is cent acetic acid, and 50 percent alco- that having an average molecular hol, no more than 50 parts per million weight of 360,000 and a maximum of extractables is obtained with each unsaturation of 1 percent, calculated as solvent. the monomer. (c) It is used or intended for use as a (b) The additive is used or intended clarifying agent in beverages and vin- for use in foods as follows: egar, followed by removal with filtration.

Food Limitations

Beer ...... As a clarifying agent, at a residual level not to exceed 10 parts per million. Flavor concentrates in tablet form ...... As a tableting adjuvent in an amount not to exceed good manufacturing practice. Nonnutritive sweeteners in concentrated liquid As a stabilizer, bodying agent, and dispersant, in an amount not to exceed form. good manufacturing practice. Nonnutritive sweeteners in tablet form ...... As a tableting adjuvant in an amount not to exceed good manufacturing practice. Vitamin and mineral concentrates in liquid form .... As a stabilizer, bodying agent, and dispersant, in an amount not to exceed good manufacturing practice. Vitamin and mineral concentrates in tablet form .... As a tableting adjuvant in an amount not to exceed good manufacturing practice. Vinegar ...... As a clarifying agent, at a residual level not to exceed 40 parts per million. Wine ...... As a clarifying agent, at a residual level not to exceed 60 parts per million.

§ 173.60 Dimethylamine- imum viscosity of 175 centipoises at 25 epichlorohydrin copolymer. °C as determined by LVT-series Brook- Dimethylamine-epichlorohydrin co- field viscometer using a No. 2 spindle polymer (CAS Reg. No. 25988–97–0) may at 60 RPM (or by another equivalent be safely used in food in accordance method). with the following prescribed condi- (3) The additive contains not more tions: than 1,000 parts per million of 1,3- (a) The food additive is produced by dichloro-2-propanol and not more than copolymerization of dimethylamine 10 parts per million epichlorohydrin. and epichlorohydrin in which not more The epichlorohydrin and 1,3-dichloro-2- than 5 mole-percent of dimethylamine propanol content is determined by an may be replaced by an equimolar analytical method entitled ‘‘The Deter- amount of ethylenediamine, and in mination of Epichlorohydrin and 1,3- which the mole ratio of total amine to Dichloro-2-Propanol in Dimethyl- epichlorohydrin is approximately 1:1. amine-Epichlorohydrin Copolymer,’’ (b) The additive meets the following which is incorporated by reference. specifications: Copies are available from the Center (1) The nitrogen content of the co- for Food Safety and Applied Nutrition polymer is 9.4 to 10.8 weight percent on (HFS–200), Food and Drug Administra- a dry basis. tion, 5100 Paint Branch Pkwy., College (2) A 50-percent-by-weight aqueous solution of the copolymer has a min-

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Park, MD 20740, or available for inspec- recommendation to remove the extraction at the Office of the Federal Reg- tion solvent to guarantee a food-grade ister, 800 North Capitol Street, NW., purity of the resin at the time of use, suite 700, Washington, DC 20408. in accordance with current good manu- (4) Heavy metals (as Pb), 2 parts per facturing practice. million maximum. (c) The temperature of the aqueous (5) Arsenic (as As), 2 parts per million food stream contacting the polymer is maximum. maintained at 79.4 °C (175 °F) or less. (c) The food additive is used as a decolorizing agent and/or flocculant in (d) The copolymer may be used in the clarification of refinery sugar liq- contact with food only of Types I, II, uors and juices. It is added only at the and VI–B (excluding carbonated bev- defecation/clarification stage of sugar erages) described in table 1 of para- liquor refining at a concentration not graph (c) of § 176.170 of this chapter. to exceed 150 parts per million of co- [50 FR 61, Jan. 2, 1985] polymer by weight of sugar solids. (d) To assure safe use of the additive, § 173.70 Chloromethylated aminated the label and labeling of the additive styrene-divinylbenzene resin. shall bear, in addition to other information required by the Act, adequate Chloromethylated aminated styrene- directions to assure use in compliance divinylbenzene copolymer (CAS Reg. with paragraph (c) of this section. No. 60177–39–1) may be safely used in food in accordance with the following [48 FR 37614, Aug. 19, 1983, as amended at 54 prescribed conditions: FR 24897, June 12, 1989] (a) The additive is an aqueous disper- § 173.65 Divinylbenzene copolymer. sion of styrene-divinylbenzene copoly- Divinylbenzene copolymer may be mers, first chloromethylated then used for the removal of organic sub- aminated with trimethylamine, having stances from aqueous foods under the an average particle size of not more following prescribed conditions: than 2.0 microns. (a) The copolymer is prepared in ap- (b) The additive shall contain no propriate physical form and is derived more than 3.0 percent nonvolatile, by the polymerization of a grade of soluble extractives when tested as fol- divinylbenzene which comprises at lows: One hundred grams of the addi- least 79 weight-percent divinylbenzene, tive is centrifuged at 17,000 r/min for 2 15 to 20 weight-percent ethylvinyl- hours. The resulting clear supernatant benzene, and no more than 4 weight- is removed from the compacted solids percent nonpolymerizable impurities. and concentrated to approximately 10 (b) In accordance with the manufac- grams on a steam bath. The 10-gram turer’s directions, the copolymer de- sample is again centrifuged at 17,000 r/ scribed in paragraph (a) of this section min for 2 hours to remove any residual is subjected to pre-use extraction with insoluble material. The supernatant a water soluble alcohol until the level from the second centrifugation is then of divinylbenzene in the extract is less removed from any compacted solids than 50 parts per billion as determined by a method titled, ‘‘The Determina- and dried to constant residual weight tion of Divinylbenzene in Alcohol Ex- using a steam bath. The percent non- tracts of Amberlite XAD–4,’’ which is volatile solubles is obtained by divid- incorporated by reference. Copies of ing the weight of the dried residue by this method are available from the the weight of the solids in the original Center for Food Safety and Applied Nu- resin dispersion. trition (HFS–200), Food and Drug Ad- (c) The additive is used as a decol- ministration, 5100 Paint Branch Pkwy., orizing and clarification agent for College Park, MD 20740, or available for treatment of refinery sugar liquors and inspection at the Office of the Federal juices at levels not to exceed 500 parts Register, 800 North Capitol Street, of additive solids per million parts of NW., suite 700, Washington, DC 20408. sugar solids. The copolymer is then treated with water according to the manufacturer’s [50 FR 29209, July 18, 1985]

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§ 173.73 Sodium polyacrylate. (2) The additive is used in an amount not to exceed 0.70 part per million in Sodium polyacrylate (CAS Reg. No. sugar juice and 1.4 parts per million in 9003–04–7) may be safely used in food in sugar liquor. accordance with the following prescribed conditions: [51 FR 11720, Apr. 7, 1986] (a) The additive is produced by the polymerization of acrylic acid and sub- Subpart B—Enzyme Preparations sequent hydrolysis of the polyacrylic and Microorganisms acid with an aqueous sodium hydroxide solution. As determined by a method § 173.110 Amyloglucosidase derived entitled ‘‘Determination of Weight Av- from Rhizopus niveus. erage and Number Average Molecular Amyloglucosidase enzyme product, Weight of Sodium Polyacrylate,’’ consisting of enzyme derived from which is incorporated by reference in Rhizopus niveus, and diatomaceous sili- accordance with 5 U.S.C. 552(a), the ad- ca as a carrier, may be safely used in ditive has— food in accordance with the following (1) A weight average molecular conditions: weight of 2,000 to 2,300; and (a) Rhizopus niveus is classified as fol- (2) A weight average molecular lows: Class, Phycomycetes; order, weight to number average molecular Mucorales; family, Mucoraceae; genus, weight ratio of not more than 1.3. Cop- Rhizopus; species, niveus. ies of the method are available from (b) The strain of Rhizopus niveus is the Center for Food Safety and Applied nonpathogenic and nontoxic in man or Nutrition (HFS–200), Food and Drug other animals. Administration, 5100 Paint Branch (c) The enzyme is produced by a proc- Pkwy., College Park, MD 20740, or ess which completely removes the or- available for inspection at the Office of ganism Rhizopus niveus from the the Federal Register, 800 North Capitol amyloglucosidase. Street, NW., suite 700, Washington, DC (d) The additive is used or intended 20408. for use for degrading gelatinized starch (b) The additive is used to control into constituent sugars, in the produc- mineral scale during the evaporation of tion of distilled spirits and vinegar. beet sugar juice or cane sugar juice in (e) The additive is used at a level not the production of sugar in an amount to exceed 0.1 percent by weight of the not to exceed 3.6 parts per million by gelatinized starch. weight of the raw juice. § 173.115 Alpha-acetolactate [53 FR 39456, Oct. 7, 1988; 53 FR 49823, Dec. 9, decarboxylase (α-ALDC) enzyme 1988] preparation derived from a recombinant Bacillus subtilis. § 173.75 Sorbitan monooleate. The food additive alpha-acetolactate Sorbitan monooleate may be safely decarboxylase (a-ALDC) enzyme prepa- used in accordance with the following ration, may be safely used in accord- prescribed conditions: ance with the following conditions: (a) The additive is produced by the (a) The food additive is the enzyme esterification of sorbitol with commer- preparation derived from a modified cial oleic acid. Bacillus subtilis strain that contains the (b) It meets the following specifica- gene coding for a-ALDC from Bacillus tions: brevis. (1) Saponification number, 145–160. (b)(1) The manufacturer produces the (2) Hydroxyl number, 193–210. additive from a pure culture fermenta- (c) The additive is used or intended tion of a strain of Bacillus subtilis that for use as follows: is nonpathogenic and nontoxigenic in (1) As an emulsifier in polymer dis- man or other animals. persions that are used in the clarifica- (2) The manufacturer may stabilize tion of cane or beet sugar juice or liq- the enzyme preparation with uor in an amount not to exceed 7.5 per- glutaraldehyde or with other suitable cent by weight in the final polymer dis- approved food additives or generally persion. recognized as safe substances.

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(3) The enzyme preparation must § 173.130 Carbohydrase derived from meet the general and additional re- Rhizopus oryzae. quirements for enzyme preparations in Carbohydrase from Rhizopus oryzae the Food Chemicals Codex, 4th ed., 1996, may be safely used in the production of pp. 133–134, which is incorporated by dextrose from starch in accordance reference. The Director of the Office of with the following prescribed condi- the Federal Register approves this in- tions: corporation by reference in accordance (a) Rhizopus oryzae is classified as fol- with 5 U.S.C. 552(a) and 1 CFR part 51. lows: Class, Phycomycetes; order, Copies may be obtained from the Na- Mucorales; family, Mucoraceae; genus, tional Academy Press, 2101 Constitu- Rhizopus; species, Rhizopus oryzae. tion Ave. NW., Washington, DC 20055, (b) The strain of Rhizopus oryzae is or may be examined at the Center for nonpathogenic and nontoxic. Food Safety and Applied Nutrition, (c) The carbohydrase is produced 5100 Paint Branch Pkwy., College Park, under controlled conditions to main- MD 20740, or at the Office of the Fed- tain nonpathogenicity and nontoxicity, eral Register, 800 North Capitol St. including the absence of aflatoxin. NW., suite 700, Washington, DC. (d) The carbohydrase is produced by a (c) The additive is used in an amount process which completely removes the not in excess of the minimum required organism Rhizopus oryzae from the to produce its intended effect as a proc- carbohydrase product. essing aid in the production of alco- (e) The carbohydrase is maintained holic malt beverages and distilled liq- under refrigeration from production to uors. use and is labeled to include the neces- sity of refrigerated storage. [66 FR 27022, May 16, 2001] § 173.135 Catalase derived from Micro- § 173.120 Carbohydrase and cellulase coccus lysodeikticus. derived from Aspergillus niger. Bacterial catalase derived from Carbohydrase and cellulase enzyme Micrococcus lysodeikticus by a pure cul- preparation derived from Aspergillus ture fermentation process may be safe- niger may be safely used in food in ac- ly used in destroying and removing hy- cordance with the following prescribed drogen peroxide used in the manufac- conditions: ture of cheese, in accordance with the (a) Aspergillus niger is classified as following conditions. follows: Class, Deuteromycetes; order, (a) The organism Micrococcus Moniliales; family, Moniliaceae; genus, lysodeikticus from which the bacterial Aspergillus; species, niger. catalase is to be derived is demonstrated to be nontoxic and nonpatho- (b) The strain of Aspergillus niger is genic. nonpathogenic and nontoxic in man or (b) The organism Micrococcus other animals. lysodeikticus is removed from the bac- (c) The additive is produced by a terial catalase prior to use of the bac- process that completely removes the terial catalase. organism Aspergillus niger from the (c) The bacterial catalase is used in carbohydrase and cellulase enzyme an amount not in excess of the min- product. imum required to produce its intended (d) The additive is used or intended effect. for use as follows: (1) For removal of visceral mass (bel- § 173.140 Esterase-lipase derived from lies) in clam processing. Mucor miehei. (2) As an aid in the removal of the Esterase-lipase enzyme, consisting of shell from the edible tissue in shrimp enzyme derived from Mucor miehei var. processing. Cooney et Emerson by a pure culture fer- (e) The additive is used in an amount mentation process, with maltodextrin not in excess of the minimum required or sweet whey as a carrier, may be to produce its intended effect. safely used in food in accordance with the following conditions:

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(a) Mucor miehei var. Cooney et Emer- Variety: raffinoseutilizer. son is classified as follows: Class, (c) The additive is used or intended Phycomycetes; subclass, Zygomycetes; for use in the production of sugar (su- order, Mucorales; family, Mucoraceae; crose) from sugar beets by addition as genus, Mucor; species, miehei; variety mycelial pellets to the molasses to in- Cooney et Emerson. crease the yield of sucrose, followed by (b) The strain of Mucor miehei var. removal of the spent mycelial pellets Cooney et Emerson is nonpathogenic and by filtration. nontoxic in man or other animals. (d) The enzyme removal is such that (c) The enzyme is produced by a proc- there are no enzyme or mycelial resi- ess which completely removes the or- dues remaining in the finished sucrose. ganism Mucor miehei var. Cooney et Emerson from the esterase-lipase. [42 FR 14526, Mar. 15, 1977, as amended at 54 (d) The enzyme is used as a flavor FR 24897, June 12, 1989] enhancer as defined in § 170.3(o)(12). § 173.150 Milk-clotting enzymes, micro- (e) The enzyme is used at levels not bial. to exceed current good manufacturing Milk-clotting enzyme produced by practice in the following food cat- pure-culture fermentation process may egories: cheeses as defined in be safely used in the production of § 170.3(n)(5) of this chapter; fat and oils cheese in accordance with the fol- as defined in § 170.(3)(n)(12) of this chap- lowing prescribed conditions: ter; and milk products as defined in (a) Milk-clotting enzyme is derived § 170.(3)(n)(31) of this chapter. Use of from one of the following organisms by this food ingredient is limited to a pure-culture fermentation process: nonstandarized foods and those foods (1) Endothia parasitica classified as for which the relevant standards of follows: Class, Ascomycetes; order, identity permit such use. Sphaeriales; family, Diaporthacesae; (f) The enzyme is used in the min- genus, Endothia; species, parasitica. imum amount required to produce its (2) Bacillus cereus classified as fol- limited technical effect. lows: Class, Schizomycetes; order, [47 FR 28090, June 29, 1982; 48 FR 2748, Jan. 21, Eubacteriales; family, Bacillaceae; 1983] genus, Bacillus; species, cereus (Frankland and Frankland). § 173.145 Alpha-Galactosidase derived (3) Mucor pusillus Lindt classified as from Mortierella vinaceae var. follows: Class, Phycomycetes; subclass, raffinoseutilizer. Zygomycetes; order, Mucorales; fam- The food additive alpha-galactosidase ily, Mucoraceae; genus, Mucor; species, and parent mycelial microorganism pusillus; variety, Lindt. Mortierella vinaceae var. raffinoseutilizer (4) Mucor miehei Cooney et Emerson may be safely used in food in accord- classified as follows: Class, ance with the following conditions: Phycomycetes; subclass, Zygomycetes; (a) The food additive is the enzyme order, Mucorales; family, Mucoraceae; alpha-galactosidase and the mycelia of genus, Mucor; species, miehei; variety, the microorganism Mortierella vinaceae Cooney et Emerson. var. raffinoseutilizer which produces the (5) Aspergillus oryzae modified by re- enzyme. combinant deoxyribonucleic (DNA) (b) The nonpathogenic microorga- techniques to contain the gene coding nism matches American Type Culture for aspartic proteinase from Collection (ATCC) No. 20034, 1 and is Rhizomucor miehei var. Cooney et Emer- classified as follows: son as defined in paragraph (a)(4) of this section, and classified as follows: Class: Phycomycetes. Order: Mucorales. Class, Blastodeuteromycetes Family: Mortierellaceae. (Hyphomycetes); order, Phialidales Genus: Mortierella. (Moniliales); genus, Aspergillus; species Species: vinaceae. oryzae. (b) The strains of organism identified 1 Available from: American Type Culture in paragraph (a) of this section are Collection, 12301 Parklawn Drive, Rockville, nonpathogenic and nontoxic in man or MD 20852. other animals.

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(c) The additive is produced by a mentation process for the production process that completely removes the of citric acid using an acceptable aque- generating organism from the milk- ous carbohydrate substrate. clotting enzyme product. (2) The organism Candida (d) The additive is used in an amount quilliermondii is made nonviable and is not in excess of the minimum required completely removed from the citric to produce its intended effect in the acid during the recovery and purifi- production of those cheeses for which cation process. it is permitted by standards of identity (d) The additive is so used that the established pursuant to section 401 of citric acid produced conforms to the the Act. specifications of the ‘‘Food Chemicals [42 FR 14526, Mar. 15, 1977; 42 FR 56728, Oct. Codex,’’ 3d Ed. (1981), under ‘‘Citric 28, 1977, as amended at 62 FR 59284, Nov. 3, acid,’’ pp. 86–87, which is incorporated 1997] by reference. Copies may be obtained from the National Academy Press, 2101 § 173.160 Candida guilliermondii. Constitution Ave. NW., Washington, The food additive Candida DC 20418, or may be examined at the guilliermondii may be safely used as the Office of the Federal Register., 800 organism for fermentation production North Capitol Street, NW., suite 700, of citric acid in accordance with the Washington, DC 20408. following conditions: (a) The food additive is the enzyme [42 FR 14526, Mar. 15, 1977, as amended at 47 system of the viable organism Candida FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, guilliermondii and its concomitant me- 1984; 54 FR 24897, June 12, 1989] tabolites produced during the fer- § 173.165 Candida lipolytica. mentation process. (b)(1) The nonpathogenic and The food additive Candida lipolytica nontoxicogenic organism descending may be safely used as the organism for from strain, American Type Culture fermentation production of citric acid Collection (ATCC) No. 20474,1 is classi- in accordance with the following condi- fied as follows: tions: (a) The food additive is the enzyme Class: Deuteromycetes. Order: Moniliales. system of the organism Candida Family: Cryptococcaceae. lipolytica and its concimitant metabo- Genus: Candida. lites produced during the fermentation Species: guilliermondii. process. Variety: guilliermondii. (b)(1) The nonpathogenic organism is (2) The toxonomic characteristics of classified as follows: the reference culture strain ATCC No. Class: Deuteromycetes. 20474 agree in the essentials with the Order: Moniliales. standard description for Candida Family: Cryptococcaceae. guilliermondii variety guilliermondii list- Genus: Candida. ed in ‘‘The Yeasts—A Toxonomic Species: lipolytica. Study;’’ 2d Ed. (1970), by Jacomina Lodder, which is incorporated by ref- (2) The taxonomic characteristics of erence. Copies are available from the the culture agree in essential with the Center for Food Safety and Applied Nu- standard description for Candida trition (HFS–200), Food and Drug Ad- lipolytica variety lipolytica listed in ministration, 5100 Paint Branch Pkwy., ‘‘The Yeasts—A Toxonomic Study,’’ 2d College Park, MD 20740, or available for Ed. (1970), by Jacomina Lodder, which inspection at the Office of the Federal is incorporated by reference. Copies are Register, 800 North Capitol Street, available from the Center for Food NW., suite 700, Washington, DC 20408. Safety and Applied Nutrition (HFS– (c)(1) The additive is used or intended 200), Food and Drug Administration, for use as a pure culture in the fer- 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at 1 Available from: American Type Culture the Office of the Federal Register, 800 Collection, 12301 Parklawn Drive, Rockville, North Capitol Street, NW., suite 700, MD 20852. Washington, DC 20408.

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(c) The additive is used or intended 4. Rotary vacuum evaporator, Buchi or for use as a pure culture in the fer- equivalent. mentation process for the production 5. Spectrophotometer—Spectral range 250– of citric acid from purified normal 400 nanometers with spectral slit width of 2 nanometers or less; under instrument oper- alkanes. ating conditions for these absorbance meas- (d) The additive is so used that the urements, the spectrophotometer shall also citric acid produced conforms to the meet the following performance require- specifications of the ‘‘Food Chemicals ments: Codex,’’ 3d Ed. (1981), pp. 86–87, which is Absorbance repeatability, ±0.01 at 0.4 ab- incorporated by reference. Copies may sorbance. ± be obtained from the National Acad- Wavelength repeatability, 0.2 nanometer. Wavelength accuracy, ±1.0 nanometer. emy Press, 2101 Constitution Ave. NW., The spectrophotometer is equipped with Washington, DC 20418, or may be exam- matched 1 centimeter path length quartz ined at the Office of the Federal Reg- microcuvettes with 0.5-milliliter volume ca- ister, 800 North Capitol Street, NW., pacity. suite 700, Wasington, DC 20408. The ad- 6. Vacuum oven, minimum inside dimen- ditive meets the following ultraviolet sions: 200 mm × 200 mm × 300 mm deep. absorbance limits when subjected to REAGENTS AND MATERIALS the analytical procedure described in this paragraph: Organic solvents. All solvents used throughout the procedure shall meet the specifica- Ultraviolet absorbance per centimeter path tions and tests described in this specifica- length Maximum tion. The methyl alcohol, isooctane, benzene, hexane and 1,2-dichloroethane designated in 280 to 289 millimicrons ...... 0.25 the list following this paragraph shall pass 290 to 299 millimicrons ...... 0.20 300 to 359 millimicrons ...... 0.13 the following test: 360 to 400 millimicrons ...... 0.03 The specified quantity of solvent is added to a 250-milliliter round bottom flask containing 0.5 milliliter of purified n-hexa- ANALYTICAL PROCEDURE FOR CITRIC ACID decane and evaporated on the rotary evapo- GENERAL INSTRUCTIONS rator at 45 °C to constant volume. Six milliliters of purified isooctane are added to this Because of the sensitivity of the test, the residue and evaporated under the same con- possibility of errors arising from contamina- ditions as above for 5 minutes. Determine tion is great. It is of the greatest importance the absorbance of the residue compared to that all glassware be scrupulously cleaned to purified n-hexadecane as reference. The ab- remove all organic matter such as oil, sorbance of the solution of the solvent res- grease, detergent residues, etc. Examine all idue shall not exceed 0.03 per centimeter glassware including stoppers and stopcocks, path length between 280 and 299 nanometers under ultraviolet light to detect any residual and 0.01 per centimeter path length between fluorescent contamination. As a pre- 300 and 400 nanometers. cautionary measure it is recommended prac- Methyl alcohol, A.C.S. reagent grade. Use 100 tice to rinse all glassware with purified iso- milliliters for the test described in the pre- octane immediately before use. No grease is ceding paragraph. If necessary, methyl alco- to be used on stopcocks or joints. Great care hol may be purified by distillation through a to avoid contamination of citric acid sam- Virgreaux column discarding the first and ples in handling is essential to assure ab- last ten percent of the distillate or other- sence of any extraneous material arising wise. from inadequate packaging. Because some of Benzene, spectrograde (Burdick and Jackson the polynuclear hydrocarbons sought in this Laboratories, Inc., Muskegon, Mich., or equiva- test are very susceptible to photo-oxidation, lent). Use 80 milliliters for the test. If nec- the entire procedure is to be carried out essary, benzene may be purified by distilla- under subdued light. tion or otherwise. Isooctane (2,2,4-trimethylpentane). Use 100 APPARATUS milliliters for the test. If necessary, iso- 1. Aluminum foil, oil free. octane may be purified by passage through a 2. Separatory funnels, 500-milliliter capac- column of activated silica gel, distillation or ity, equipped with tetrafluoroethylene poly- otherwise. mer stopcocks. Hexane, spectrograde (Burdick and Jackson 3. Chromatographic tubes: (a) 80-milli- Laboratories, Inc., Muskegon, Mich., or equiva- meter ID × 900-millimeter length equipped lent). Use 100 milliliters for the test. If nec- with tetrafluoroethylene polymer stopcock essary, hexane may be purified by distilla- and course fritted disk; (b) 18-millimeter ID tion or otherwise. × 300-millimeter length equipped with tetra- 1,2-Dichloroethane, spectrograde (Matheson, fluoroethylene polymer stopcock. Coleman and Bell, East Rutherford, N.J., or

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equivalent). Use 100 milliliters for the test. If grams of anhydrous citric acid into a 500 mil- necessary, 1,2-dichloroethane may be puri- liliter flask and dissolve in 200 milliliters of fied by distillation or otherwise. pure water. Heat the solution to 60 °C and transfer to a 500 milliliter separatory funnel. ELUTING MIXTURES Rinse the flask with 50 milliliters of iso- 1. 10 percent 1,2-dichloroethane in hexane. octane and add the isooctane to the sepa- Prepare by mixing the purified solvents in ratory funnel. Gently shake the mixture 90 the volume ratio of 1 part of 1,2- times (caution: vigorous shaking will cause dichloroethane to 9 parts of hexane. emulsions) with periodic release of the pres- 2. 40 percent benzene in hexane. Prepare by sure caused by shaking. mixing the purified solvents in the volume Allow the phases to separate for at least 5 ratio of 4 parts of benzene to 6 parts of minutes. Draw off the lower aqueous layer hexane. into a second 500-milliliter separatory funnel n-Hexadecane, 99 percent olefin-free. Deter- and repeat the extraction with a second ali- mine the absorbance compared to isooctane quot of 50 milliliters of isooctane. After sep- as reference. The absorbance per centimeter aration of the layers, draw off and discard path length shall not exceed 0.00 in the range the water layer. Combine both isooctane ex- of 280–400 nanometers. If necessary, n-hexa- tracts in the funnel containing the first ex- decane may be purified by percolation tract. Rinse the funnel which contained the through activated silica gel, distillation or second extract with 10 milliliters of iso- otherwise. octane and add this portion to the combined Silica gel, 28–200 mesh (Grade 12, Davison isooctane extract. Chemical Co., Baltimore, MD, or equivalent). A chromatographic column containing 5.5 Activate as follows: Slurry 900 grams of sili- grams of silica gel and 3 grams of anhydrous ca gel reagent with 2 liters of purified water sodium sulfate is prepared for each citric in a 3-liter beaker. Cool the mixture and acid sample as follows: Fit 18 × 300 column pour into a 80 × 900 chromatographic column with a small glass wool plug. Rinse the in- with coarse fritted disc. Drain the water, side of the column with 10 milliliters of puri- wash with an additional 6 liters of purified fied isooctane. Drain the isooctane from the water and wash with 3,600 milliliters of puri- column. Pour 5.5 grams of activated silica fied methyl alcohol at a relatively slow rate. gel into the column. Tap the column ap- Drain all of the solvents and transfer the proximately 20 times on a semisoft, clean silica gel to an aluminum foil-lined drying surface to settle the silica gel. Carefully dish. Place foil over the top of the dish. Acti- pour 3 grams of anhydrous sodium sulfate vate in a vacuum oven at low vacuum (ap- onto the top of the silica gel in the column. proximately 750 millimeters Mercury or 27 Carefully drain the isooctane extract of inches of Mercury below atmospheric pres- the citric acid solution into the column in a sure) at 173° to 177 °C for at least 20 hours. series of additions while the isooctane is Cool under vacuum and store in an amber draining from the column at an elution rate bottle. of approximately 3 milliliters per minute. Sodium sulfate, anhydrous, A.C.S. reagent Rinse the separatory funnel with 10 milli- grade. This reagent should be washed with liters of isooctane after the last portion of purified isooctane. Check the purity of this the extract has been applied to the column reagent as described in § 172.886 of this chap- and add this rinse to the column. After all of ter. the extract has been applied to the column Water, purified. All water used must meet and the solvent layer reaches the top of the the specifications of the following test: sulfate bed, rinse the column with 25 milli- Extract 600 milliliters of water with 50 milliters of isooctane followed by 10 milliliters liliters of purified isooctane. Add 1 milliliter of a 10-percent dichloroethane in hexane so- of purified n-hexadecane to the isooctane ex- lution. For each rinse solution, drain the col- tract and evaporate the resulting solution to umn until the solvent layer reaches the top 1 milliliter. The absorbance of this residue of the sodium sulfate bed. Discard the rinse shall not exceed 0.02 per centimeter path solvents. Place a 250-milliliter round bottom length between 300–400 nanometers and 0.03 flask containing 0.5 milliliter of purified n- per centimeter path length between 280–299 hexadecane under the column. Elute the nanometers. If necessary, water may be puri- polynuclear aromatic hydrocarbons from the fied by distillation, extraction with purified column with 30 milliliters of 40-percent ben- organic solvents, treatment with an absorb- zene in hexane solution. Drain the eluate ent (e.g., activated carbon) followed by fil- until the 40-percent benzene in the hexane tration of the absorbent or otherwise. solvent reaches the top of the sodium sulfate bed. PROCEDURE Evaporate the 40-percent benzene in Separate portions of 200 milliliters of puri- hexane eluate on the rotary vacuum evapo- fied water are taken through the procedure rator at 45 °C until only the n-hexadecane for use as control blanks. Each citric acid residue of 0.5 milliliter remains. Treat the n- sample is processed as follows: Weigh 200 hexadecane residue twice with the following

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wash step: Add 6 milliliters of purified iso- oleoresins when present therein as a octane and remove the solvents by vacuum residue from the extraction of spice. evaporation at 45 °C to constant volume, i.e., 0.5 milliliter. Cool the n-hexadecane residue § 173.220 1,3-Butylene glycol. and transfer the solution to an 0.5-milliliter microcuvette. Determine the absorbance of 1,3-Butylene glycol (1,3-butanediol) this solution compared to purified n-hexa- may be safely used in food in accord- decane as reference. Correct the absorbance ance with the following prescribed con- values for any absorbance derived from the ditions: control reagent blank. If the corrected absorbance does not exceed the limits pre- (a) The substance meets the fol- scribed, the samples meet the ultraviolet ab- lowing specifications: sorbance specifications. (1) 1,3-Butylene glycol content: Not The reagent blank is prepared by using 200 less than 99 percent. milliliters of purified water in place of the (2) Specific gravity at 20/20 °C: 1.004 citric acid solution and carrying the water sample through the procedure. The typical to 1.006. control reagent blank should not exceed 0.03 (3) Distillation range: 200°–215 °C. absorbance per centimeter path length be- (b) It is used in the minimum amount tween 280 and 299 nanometers, 0.02 absorb- required to perform its intended effect. ance per centimeter path length between 300 (c) It is used as a solvent for natural and 359 nanometers, and 0.01 absorbance per centimeter path length between 360 and 400 and synthetic flavoring substances ex- nanometers. cept where standards of identity issued under section 401 of the act preclude [42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, such use. 1984; 54 FR 24897, June 12, 1989] § 173.228 Ethyl acetate. § 173.170 Aminoglycoside 3′-phospho- Ethyl acetate (CAS Reg. No. 141–78–6) transferase II. may be safely used in food in accord- The food additive aminoglycoside 3′- ance with the following conditions: phosphotransferase II may be safely (a) The additive meets the specifica- used in the development of genetically tions of the Food Chemicals Codex, 1 modified cotton, oilseed rape, and to- (Ethyl Acetate; p. 372, 3d Ed., 1981), matoes in accordance with the fol- which are incorporated by reference. lowing prescribed conditions: (b) The additive is used in accordance (a) The food additive is the enzyme with current good manufacturing prac- ′ aminoglycoside 3 -phosphotransferase tice as a solvent in the decaffeination II (CAS Reg. No. 58943–39–8) which cata- of coffee and tea. lyzes the phosphorylation of certain aminoglycoside antibiotics, including [47 FR 146, Jan. 5, 1982, as amended at 49 FR kanamycin, neomycin, and gentamicin. 28548, July 13, 1984] (b) Aminoglycoside 3′-phosphotransferase II is encoded by the kanr gene § 173.230 Ethylene dichloride. originally isolated from transposon Tn5 A tolerance of 30 parts per million is of the bacterium Escherichia coli. established for ethylene dichloride in (c) The level of the additive does not spice oleoresins when present therein exceed the amount reasonably required as a residue from the extraction of for selection of plant cells carrying the spice; Provided, however, That if resi- kanr gene along with the genetic mate- dues of other chlorinated solvents are rial of interest. also present the total of all residues of [59 FR 26711, May 23, 1994] such solvents shall not exceed 30 parts per million. Subpart C—Solvents, Lubricants, Release Agents and Related 1 Copies may be obtained from: National Substances Academy Press, 2101 Constitution Ave. NW., § 173.210 Acetone. Washington, DC 20418 or examined at the Of- fice of the Federal Register, 800 North Cap- A tolerance of 30 parts per million is itol Street, NW., suite 700, Washington, DC established for acetone in spice 20408.

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§ 173.240 Isopropyl alcohol. (1) The hops extract is added to the wort before or during cooking in the Isopropyl alcohol may be present in manufacture of beer. the following foods under the condi- (2) The label of the hops extract iden- tions specified: tifies the presence of the methylene (a) In spice oleoresins as a residue chloride and provides for the use of the from the extraction of spice, at a level hops extract only as prescribed by not to exceed 50 parts per million. paragraph (b)(1) of this section. (b) In lemon oil as a residue in pro- (c) In coffee as a residue from its use duction of the oil, at a level not to ex- as a solvent in the extraction of caf- ceed 6 parts per million. feine from green coffee beans, at a level (c) In hops extract as a residue from not to exceed 10 parts per million (0.001 the extraction of hops at a level not to percent) in decaffeinated roasted coffee exceed 2.0 percent by weight: Provided, and in decaffeinated soluble coffee ex- That, tract (instant coffee). (1) The hops extract is added to the wort before or during cooking in the § 173.270 Hexane. manufacture of beer. Hexane may be present in the fol- (2) The label of the hops extract lowing foods under the conditions spec- specifies the presence of the isopropyl ified: alcohol and provides for the use of the (a) In spice oleoresins as a residue hops extract only as prescribed by from the extraction of spice, at a level paragraph (c)(1) of this section. not to exceed 25 parts per million. (b) In hops extract as a residue from § 173.250 Methyl alcohol residues. the extraction of hops, at a level not to Methyl alcohol may be present in the exceed 2.2 percent by weight; Provided, following foods under the conditions That: specified: (1) The hops extract is added to the (a) In spice oleoresins as a residue wort before or during cooking in the from the extraction of spice, at a level manufacture of beer. not to exceed 50 parts per million. (2) The label of the hops extract specifies the presence of the hexane (b) In hops extract as a residue from and provides for the use of the hops ex- the extraction of hops, at a level not to tract only as prescribed by paragraph exceed 2.2 percent by weight; Provided, (b)(1) of this section. That: (1) The hops extract is added to the § 173.275 Hydrogenated sperm oil. wort before or during cooking in the The food additive hydrogenated manufacture of beer. sperm oil may be safely used in accord- (2) The label of the hops extract ance with the following prescribed con- specifies the presence of methyl alco- ditions: hol and provides for the use of the hops (a) The sperm oil is derived from ren- extract only as prescribed by para- dering the fatty tissue of the sperm graph (b)(1) of this section. whale or is prepared by synthesis of § 173.255 Methylene chloride. fatty acids and fatty alcohols derived from the sperm whale. The sperm oil Methylene chloride may be present in obtained by rendering is refined. The food under the following conditions: oil is hydrogenated. (a) In spice oleoresins as a residue (b) It is used alone or as a component from the extraction of spice, at a level of a release agent or lubricant in bak- not to exceed 30 parts per million; Pro- ery pans. vided, That, if residues of other (c) The amount used does not exceed chlorinated solvents are also present, that reasonably required to accomplish the total of all residues of such sol- the intended lubricating effect. vents shall not exceed 30 parts per million. § 173.280 Solvent extraction process (b) In hops extract as a residue from for citric acid. the extraction of hops, at a level not to A solvent extraction process for re- exceed 2.2 percent, Provided, That: covery of citric acid from conventional

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Aspergillus niger fermentation liquor Subpart D—Specific Usage may be safely used to produce food- Additives grade citric acid in accordance with the following conditions: § 173.300 Chlorine dioxide. (a) The solvent used in the process consists of a mixture of n-octyl alcohol Chlorine dioxide (CAS Reg. No. 10049– meeting the requirements of § 172.864 of 04–4) may be safely used in food in ac- this chapter, synthetic isoparaffinic cordance with the following prescribed petroleum hydrocarbons meeting the conditions: requirements of § 172.882 of this chap- (a) The additive is generated by one ter, and tridodecyl amine. of the following methods: Treating an (b) The component substances are aqueous solution of sodium chlorite used solely as a solvent mixture and in with either chlorine gas or a mixture of a manner that does not result in for- sodium hypochlorite and hydrochloric mation of products not present in con- acid, or treating an aqueous solution of ventionally produced citric acid. sodium chlorate with hydrogen per- (c) The citric acid so produced meets oxide in the presence of sulfuric acid. the specifications of the ‘‘Food Chemi- In either case, the generator effluent cals Codex,’’ 3d Ed. (1981), pp. 86–87, contains at least 90 percent (by weight) which is incorporated by reference (copies may be obtained from the Na- of chlorine dioxide with respect to all tional Academy Press, 2101 Constitu- chlorine species as determined by tion Ave. NW., Washington, DC 20418, Method 4500–ClO2 E in the ‘‘Standard or may be examined at the Office of the Methods for the Examination of Water Federal Register, 800 North Capitol and Wastewater,’’ 18th ed., 1992, or an Street, NW., suite 700, Washington, DC equivalent method. Method 4500–ClO2 E 20408), and the polynuclear aromatic is incorporated by reference in accord- hydrocarbon specifications of § 173.165. ance with 5 U.S.C. 552(a) and 1 CFR (d) Residues of n-octyl alcohol and part 51. Copies are available from the synthetic isoparaffinic petroleum hy- Center for Food Safety and Applied Nu- drocarbons are removed in accordance trition (HFS–200), Food and Drug Ad- with good manufacturing practice. Cur- ministration, 5100 Paint Branch Pkwy., rent good manufacturing practice re- College Park, MD 20740, and the Amer- sults in residues not exceeding 16 parts ican Public Health Association, 1015 per million (ppm) n-octyl alcohol and Fifteenth St. NW., Washington, DC 0.47 ppm synthetic isoparaffinic petro- 20005, or may be examined at the Office leum hydrocarbons in citric acid. of the Federal Register, 800 North Cap- (e) Tridodecyl amine may be present itol St. NW., suite 700, Washington, DC. as a residue in citric acid at a level not to exceed 100 parts per billion. (b)(1) The additive may be used as an antimicrobial agent in water used in [42 FR 14491, Mar. 15, 1977, as amended at 49 poultry processing in an amount not to FR 10106, Mar. 19, 1984] exceed 3 parts per million (ppm) resid- § 173.290 Trichloroethylene. ual chlorine dioxide as determined by Method 4500–ClO E, referenced in para- Tolerances are established for resi- 2 graph (a) of this section, or an equiva- dues of trichloroethylene resulting lent method. from its use as a solvent in the manufacture of foods as follows: (2) The additive may be used as an Decaffeinated ground 25 parts per million. antimicrobial agent in water used to coffee. wash fruits and vegetables that are not Decaffeinated soluble 10 parts per million. raw agricultural commodities in an (instant) coffee extract. Spice oleoresins ...... 30 parts per million (pro- amount not to exceed 3 ppm residual vided that if residues chlorine dioxide as determined by of other chlorinated Method 4500–ClO E, referenced in para- solvents are also 2 present, the total of all graph (a) of this section, or an equiva- residues of such sol- lent method. Treatment of the fruits vents in spice and vegetables with chlorine dioxide oleoresins shall not exceed 30 parts per mil- shall be followed by a potable water lion).

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rinse or by blanching, cooking, or can- (a) The amount of additive is not in ning. excess of that required for its func- [60 FR 11900, Mar. 3, 1995. Redesignated at 61 tional purpose, and the amount of FR 14245, Apr. 1, 1996, as amended at 61 FR steam in contact with food does not ex- 14480, Apr. 2, 1996; 63 FR 38747, July 20, 1998; ceed that required to produce the in- 65 FR 34587, May 31, 2000] tended effect in or on the food. (b) The compounds are prepared from § 173.310 Boiler water additives. substances identified in paragraphs (c) Boiler water additives may be safely and (d) of this section, and are subject used in the preparation of steam that to the limitations, if any, prescribed: will contact food, under the following (c) List of substances: conditions:

Substances Limitations

Acrylamide-sodium acrylate resin ...... Contains not more than 0.05 percent by weight of acrylamide monomer. Acrylic acid/2-acrylamido-2-methyl propane sulfonic acid copoly- Total not to exceed 20 parts per million (active) in boiler mer having a minimum weight average molecular weight of feedwater. 9,900 and a minimum number average molecular weight of 5,700 as determined by a method entitled ‘‘Determination of Weight Average and Number Average Molecular Weight of 60/40 AA/AMPS’’ (October 23, 1987), which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies may be obtained from the Center for Food Safety and Applied Nu- trition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC. Ammonium alginate. Cobalt sulfate (as catalyst). 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809–21–4) and its sodium and potassium salts. Lignosulfonic acid. Monobutyl ethers of polyethylene-polypropylene glycol produced Minimum mol. wt. 1,500. by random condensation of a 1:1 mixture by weight of ethylene oxide and propylene oxide with butanol. Poly(acrylic acid-co-hypophosphite), sodium salt (CAS Reg. No. Total not to exceed 1.5 parts per million in boiler feed water. 71050–62–9), produced from a 4:1 to a 16:1 mixture by Copolymer contains not more than 0.5 percent by weight of weight of acrylic acid and sodium hypophosphite. acrylic acid monomer (dry weight basis). Polyethylene glycol ...... As defined in § 172.820 of this chapter. Polymaleic acid [CAS Reg. No. 26099–09–2], and/or its sodium Total not to exceed 1 part per million in boiler feed water (cal- salt. [CAS Reg. No. 30915–61–8 or CAS Reg. No. 70247– culated as the acid). 90–4]. Polyoxypropylene glycol ...... Minimum mol. wt. 1,000. Potassium carbonate. Potassium tripolyphosphate. Sodium acetate. Sodium alginate. Sodium aluminate. Sodium carbonate. Sodium carboxymethylcellulose...... Contains not less than 95 percent sodium carboxymethylcellulose on a dry-weight basis, with maximum substitution of 0.9 carboxymethylcellulose groups per anhydroglucose unit, and with a minimum viscosity of 15 centipoises for 2 percent by weight aqueous solution at 25 °C; by the method prescribed in the ‘‘Food Chemicals Codex,’’ 4th ed. (1996), pp. 744–745, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address http://www.nap.edu), or may be examined at the Center for Food Safety and Applied Nutri- tion’s Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. Sodium glucoheptonate...... Less than 1 part per million cyanide in the sodium glucoheptonate. Sodium hexametaphosphate. Sodium humate. Sodium hydroxide.

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Substances Limitations

Sodium lignosulfonate. Sodium metabisulfite. Sodium metasilicate. Sodium nitrate. Sodium phosphate (mono-, di-, tri-). Sodium polyacrylate. Sodium polymethacrylate. Sodium silicate. Sodium sulfate. Sodium sulfite (neutral or alkaline). Sodium tripolyphosphate. Sorbitol anhydride esters: a mixture consisting of sorbitan The mixture is used as an anticorrosive agent in steam boiler monostearate as defined in § 172.842 of this chapter; poly- distribution systems, with each component not to exceed 15 sorbate 60 ((polyoxyethylene (20) sorbitan monostearate)) as parts per million in the steam. defined in § 172.836 of this chapter; and polysorbate 20 ((polyoxyethylene (20) sorbitan monolaurate)), meeting the specifications of the Food Chemicals Codex, 4th ed. (1996), pp. 306–307, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitu- tion Ave. NW., Box 285, Washington, DC 20055 (Internet http://www.nap.edu), or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. Tannin (including quebracho extract). Tetrasodium EDTA. Tetrasodium pyrophosphate.

(d) Substances used alone or in combination with substances in paragraph (c) of this section:

Substances Limitations

Cyclohexylamine ...... Not to exceed 10 parts per million in steam, and excluding use of such steam in contact with milk and milk products. Diethylaminoethanol ...... Not to exceed 15 parts per million in steam, and excluding use of such steam in contact with milk and milk products. Hydrazine ...... Zero in steam. Morpholine ...... Not to exceed 10 parts per million in steam, and excluding use of such steam in contact with milk and milk products. Octadecylamine ...... Not to exceed 3 parts per million in steam, and excluding use of such steam in contact with milk and milk products. Trisodium nitrilotriacetate ...... Not to exceed 5 parts per million in boiler feedwater; not to be used where steam will be in contact with milk and milk products.

(e) To assure safe use of the additive, (2) Adequate directions for use to as- in addition to the other information re- sure compliance with all the provisions quired by the Act, the label or labeling of this section. shall bear: [42 FR 14526, Mar. 15, 1977, as amended at 45 (1) The common or chemical name or FR 73922, Nov. 7, 1980; 45 FR 85726, Dec. 30, names of the additive or additives. 1980; 48 FR 7439, Feb. 22, 1983; 49 FR 5748, Feb. 15, 1984; 49 FR 10106, Mar. 19, 1984; 50 FR 49536, Dec. 3, 1985; 53 FR 15199, Apr. 28, 1988; 54 FR 31012, July 26, 1989; 55 FR 12172, Apr. 2, 1990; 61 FR 14245, Apr. 1, 1996; 64 FR 1759, Jan. 12, 1999; 64 FR 29227, June 1, 1999]

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§ 173.315 Chemicals used in washing (a) The chemicals consist of one or or to assist in the peeling of fruits more of the following: and vegetables. (1) Substances generally recognized Chemicals may be safely used to as safe in food or covered by prior sanc- wash or to assist in the peeling of tions for use in washing fruits and vegetables. fruits and vegetables in accordance (2) Substances identified in this sub- with the following conditions: paragraph and subject to such limitations as are provided:

Substances Limitations

A mixture of alkylene oxide adducts of alkyl alcohols and phosphate May be used at a level not to exceed 0.2 percent in esters of alkylene oxide adducts of alkyl alcohols consisting of: a-alkyl lye-peeling solution to assist in the lye peeling of (C12-C18)-omega-hydroxy-poly (oxyethylene) (7.5–8.5 moles)/poly fruit and vegetables. (oxypropylene) block copolymer having an average molecular weight of 810; a-alkyl (C12-C18)-omega-hydroxy-poly (oxyethylene) (3.3–3.7 moles) polymer having an average molecular weight of 380, and subsequently esterified with 1.25 moles phosphoric anhydride; and a-alkyl (C10-C12)-omega-hydroxypoly (oxyethylene) (11.9–12.9 moles)/poly (oxypropylene) copolymer, having an average molecular weight of 810, and subsequently esterified with 1.25 moles phosphoric anhydride. Aliphatic acid mixture consisting of valeric, caproic, enanthic, caprylic, May be used at a level not to exceed 1 percent in lye and pelargonic acids. peeling solution to assist in the lye peeling of fruits and vegetables. Polyacrylamide ...... Not to exceed 10 parts per million in wash water. Contains not more than 0.2 percent acrylamide monomer. May be used in the washing of fruits and vegetables. Potassium bromide ...... May be used in the washing or to assist in the lye peeling of fruits and vegetables. Sodium n-alkylbenzene-sulfonate (alkyl group predominantly C12 and C13 Not to exceed 0.2 percent in wash water. May be and not less than 95 percent C10 to C16). used in washing or to assist in the lye peeling of fruits and vegetables. Sodium dodecylbenzene-sulfonate (alkyl group predominantly C12 and Do. not less than 95% C10 to C16). Sodium 2 ethyl-hexyl sulfate ...... Do. Sodium hypochlorite ...... May be used in the washing or to assist in the lye peeling of fruits and vegetables. Sodium mono- and dimethyl naphthalene sulfonates (mol. wt. 245–260) Not to exceed 0.2 percent in wash water. May be used in the washing or to assist in the lye peeling of fruits and vegetables.

(3) Sodium mono- and dimethyl naph- Substance Limitations thalene sulfonates (mol. wt. 245–260) Dialkanolamide produced by con- Not to exceed 2 ppm. may be used in the steam/scald vacuum densing 1 mole of methyl lau- peeling of tomatoes at a level not to rate with 1.05 moles of exceed 0.2 percent in the condensate or diethanolamine. scald water. Triethanolamine ...... Do. Ethylene glycol monobutyl ether .. Not to exceed 1 ppm. (4) Substances identified in this para- Oleic acid conforming with Do. graph (a)(4) for use in flume water for § 172.860 of this chapter. washing sugar beets prior to the slicing Tetrapotassium pyrophosphate .... Not to exceed 0.3 ppm. operation and subject to the limita- Monoethanolamine ...... Do. Ethylene dichloride ...... Not to exceed 0.2 ppm. tions as are provided for the level of Tetrasodium ethylenediamine- Not to exceed 0.1 ppm. the substances in the flume water: tetraacetate.

Substance Limitations (5) Substances identified in this para- a-Alkyl-omega-hydroxypoly-(oxy- Not to exceed 3 ppm. graph (a)(5) for use on fruits and vege- ethylene) produced by con- tables that are not raw agricultural densation of 1 mole of C11- commodities and subject to the limita- C486315 straight chain randomly substituted secondary al- tions provided: cohols with an average of 9 moles of ethylene oxide. Linear undecylbenzenesulfonic Do. acid.

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Substances Limitations Parts per mil- Hydrogen peroxide ...... Used in combination with acetic lion acid to form peroxyacetic acid. Not to exceed 59 ppm in wash Disodium cyanodithioimidocarbonate ...... 2.5 water. Ethylenediamine ...... 1.0 1-Hydroxyethylidene-1,1- May be used only with peroxy- Potassium N-methyldithiocarbamate ...... 3.5 diphosphonic acid. acetic acid. Not to exceed 4.8 ppm in wash water. (2) Combination for cane-sugar mills: Peroxyacetic acid ...... Prepared by reacting acetic acid with hydrogen peroxide. Not to Parts exceed 80 ppm in wash water. per million

(b) The chemicals are used in Disodium ethylenebisdithiocarbamate ...... 3.0 amounts not in excess of the minimum Sodium dimethyldithiocarbamate ...... 3.0 required to accomplish their intended effect. (3) Combinations for cane-sugar mills (c) The use of the chemicals listed and beet-sugar mills: under paragraphs (a)(1), (a)(2), and Parts (a)(4) is followed by rinsing with pota- per mil- ble water to remove, to the extent pos- lion sible, residues of the chemicals. (i) Disodium ethylenebisdithiocarbamate ...... 3.0 (d) To assure safe use of the additive: Ethylenediamine ...... 2.0 Sodium dimethyldithiocarbamate ...... 3.0 (1) The label and labeling of the addi- (ii) Disodium cyanodithioimidocarbonate ...... 2.9 tive container shall bear, in addition to Potassium N-methyldithiocarbamate ...... 4.1 the other information required by the act, the name of the additive or a (4) Single additive for cane-sugar statement of its composition. mills and beet-sugar mills. (2) The label or labeling of the addi- Parts per million tive container shall bear adequate use directions to assure use in compliance 2,2-Dibromo-3-nitrilopropionamide (CAS Not more than with all provisions of this section. Reg. No. 10222–01–2). Limitations: By- 10.0 and not product molasses, bagasse, and pulp less than 2.0. [42 FR 14526, Mar. 15, 1977, as amended at 42 containing residues of 2,2-dibromo-3- nitrilopropionamide are not authorized FR 29856, June 10, 1977; 42 FR 32229, June 24, for use in animal feed. 1977; 43 FR 54926, Nov. 24, 1978; 61 FR 46376, 46377, Sept. 3, 1996; 63 FR 7069, Feb. 12, 1998; (5) Combination for cane-sugar mills: 64 FR 38564, July 19, 1999] Parts per mil- § 173.320 Chemicals for controlling lion microorganisms in cane-sugar and n-Dodecyl dimethyl benzyl ammonium chlo- beet-sugar mills. ride ...... 0.05±0.005 Agents for controlling microorga- n-Dodecyl dimethyl ethylbenzyl ammonium chloride ...... 0.68±0.068 nisms in cane-sugar and beet-sugar n-Hexadecyl dimethyl benzyl ammonium mills may be safely used in accordance chloride ...... 0.30±0.030 with the following conditions: n-Octadecyl dimethyl benzyl ammonium chloride ...... 0.05±0.005 (a) They are used in the control of n-Tetradecyl dimethyl benzyl ammonium microorganisms in cane-sugar and/or chloride ...... 0.60±0.060 beet-sugar mills as specified in para- n-Tetradecyl dimethyl ethylbenzyl ammo- graph (b) of this section. nium chloride ...... 0.32±0.032 (b) They are applied to the sugar mill grinding, crusher, and/or diffuser sys- Limitations. Byproduct molasses, ba- tems in one of the combinations listed gasse, and pulp containing residues of in paragraph (b) (1), (2), (3), or (5) of these quaternary ammonium salts are this section or as a single agent listed not authorized for use in animal feed. in paragraph (b) (4) or (6) of this sec- (6) Single additive for beet-sugar tion. Quantities of the individual addi- mills: tives in parts per million are expressed Parts per million in terms of the weight of the raw cane or raw beets. Glutaraldehyde (CAS Reg. No. Not more than 250. 111–30–8). (1) Combination for cane-sugar mills:

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(c) To assure safe use of the addi- the intact carcass in a prechiller or tives, their label and labeling shall chiller tank; conform to that registered with the (ii) In a prechiller or chiller solution Environmental Protection Agency. for application to the intact carcass; (iii) As a component of a spray or dip [42 FR 14526, Mar. 15, 1977, as amended at 47 FR 35756, Aug. 17, 1982; 50 FR 3891, Jan. 29, solution for application to poultry car- 1985; 57 FR 8065, Mar. 6, 1992] cass parts; (iv) In a prechiller or chiller solution § 173.322 Chemicals used in delinting for application to poultry carcass cottonseed. parts; or Chemicals may be safely used to as- (v) As a component of a post-chill sist in the delinting of cottonseed in carcass spray or dip solution when ap- accordance with the following condi- plied to poultry meat, organs, or re- tions: lated parts or trim. (a) The chemicals consist of one or (2) When used in a spray or dip solu- more of the following: tion, the additive is used at levels that (1) Substances generally recognized result in sodium chlorite concentra- as safe for direct addition to food. tions between 500 and 1,200 parts per (2) Substances identified in this para- million (ppm), in combination with any graph and subject to such limitations GRAS acid at a level sufficient to as are provided: achieve a solution pH of 2.3 to 2.9. (3) When used in a prechiller or chill- Substances Limitations er solution, the additive is used at lev- alpha-Alkyl-omega- May be used at an applica- els that result in sodium chlorite con- hydroxypoly-(oxyethylene) tion rate not to exceed 0.3 centrations between 50 and 150 ppm, in produced by condensation percent by weight of cot- combination with any GRAS acid at of a linear primary alcohol tonseeds to enhance containing an average delinting of cottonseeds in- levels sufficient to achieve a solution chain length of 10 carbons tended for the production pH of 2.8 to 3.2. with poly(oxyethylene) hav- of cottonseed oil. Byprod- (c) The additive is used as an anti- ing an average of 5 ethyl- ucts including lint, hulls, ene oxide units. and meal may be used in microbial agent in accordance with animal feed. current industry practice in the proc- An alkanomide produced by May be used at an applica- essing of red meat, red meat parts, and condensation of coconut oil tion rate not to exceed 0.2 organs as a component of a spray or in fatty acids and dietha- percent by weight of cot- nolamine, CAS Reg. No. tonseeds to enhance the processing of red meat parts and 068603–42–9. delinting of cottonseeds in- organs as a component of a dip. Applied tended for the production as a dip or spray, the additive is used of cottonseed oil. Byprod- ucts including lint, hulls, at levels that result in sodium chlorite and meal may be used in concentrations between 500 and 1,200 animal feed. ppm in combination with any GRAS acid at levels sufficient to achieve a so- [47 FR 8346, Feb. 26, 1982] lution pH of 2.5 to 2.9. (d) The additive is used as an anti- § 173.325 Acidified sodium chlorite so- microbial agent in water and ice that lutions. are used to rinse, wash, thaw, trans- Acidified sodium chlorite solutions port, or store seafood in accordance may be safely used in accordance with with current industry standards of the following prescribed conditions: good manufacturing practice. The addi- (a) The additive is produced by mix- tive is produced by mixing an aqueous ing an aqueous solution of sodium chlo- solution of sodium chlorite with any rite (CAS Reg. No. 7758–19–2) with any GRAS acid to achieve a pH in the range generally recognized as safe (GRAS) of 2.5 to 2.9 and diluting this solution acid. with water to achieve an actual use (b)(1) The additive is used as an anti- concentration of 40 to 50 parts per mil- microbial agent in poultry processing lion (ppm) sodium chlorite. Any sea- water in accordance with current in- food that is intended to be consumed dustry practice under the following raw shall be subjected to a potable conditions: water rinse prior to consumption. (i) As a component of a carcass spray (e) The additive is used as an anti- or dip solution prior to immersion of microbial agent on raw agricultural

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commodities in the preparing, packing, dip treatment only, and must be pre- or holding of the food for commercial ceded by a potable water rinse and fol- purposes, consistent with section lowed by a potable water rinse and a 201(q)(1)(B)(i) of the act, and not ap- 24-hour holding period prior to con- plied for use under section sumption. When used in a spray or dip 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or solution, the additive is used at levels (q)(1)(B)(i)(III) of the act, in accordance that result in sodium chlorite con- with current industry standards of centrations between 500 and 1,200 ppm, good manufacturing practice. Applied in combination with any GRAS acid at as a dip or a spray, the additive is used a level sufficient to achieve a solution at levels that result in chlorite con- pH of 2.3 to 2.9. centrations of 500 to 1200 parts per mil- (h) The concentration of sodium chlo- lion (ppm), in combination with any rite is determined by a method entitled GRAS acid at levels sufficient to ‘‘Determination of Sodium Chlorite: 50 achieve a pH of 2.3 to 2.9. Treatment of ppm to 1500 ppm Concentration,’’ Sep- the raw agricultural commodities with tember 13, 1995, developed by Alcide acidified sodium chlorite solutions Corp., Redmond, WA, which is incor- shall be followed by a potable water porated by reference in accordance rinse, or by blanching, cooking, or can- with 5 U.S.C. 552(a) and 1 CFR part 51. ning. Copies are available from the Division (f) The additive is used as an anti- of Petition Control (HFS–215), Center microbial agent on processed, for Food Safety and Applied Nutrition, comminuted or formed meat food prod- Food and Drug Administration, 5100 ucts (unless precluded by standards of Paint Branch Pkwy., College Park, MD identity in 9 CFR part 319) prior to 20740, or may be examined at the Cen- packaging of the food for commercial ter for Food Safety and Applied Nutri- purposes, in accordance with current tion’s Library, 5100 Paint Branch industry standards of good manufac- Pkwy., College Park, MD 20740 20204– turing practice. Applied as a dip or 0001, or the Office of the Federal Reg- spray, the additive is used at levels ister, 800 North Capitol St. NW., Suite that result in sodium chlorite con- 700, Washington, DC. centrations of 500 to 1200 ppm, in combination with any GRAS acid at levels [61 FR 17829, Apr. 23, 1996, as amended at 63 sufficient to achieve a pH of 2.5 to 2.9. FR 11119, Mar. 6, 1998; 64 FR 44123, Aug. 13, (g) The additive is used as an anti- 1999; 64 FR 49982, Sept. 15, 1999; 65 FR 1776, microbial agent in the water applied to Jan. 12, 2000; 65 FR 16312, Mar. 28, 2000; 66 FR processed fruits and processed root, 22922, May 7, 2001; 66 FR 31841, June 13, 2001; 67 FR 15720, Apr. 3, 2002] tuber, bulb, legume, fruiting (i.e., eggplant, groundcherry, pepino, pepper, § 173.340 Defoaming agents. tomatillo, and tomato), and cucurbit vegetables in accordance with current Defoaming agents may be safely used industry standards of good manufac- in processing foods, in accordance with turing practices, as a component of a the following conditions: spray or dip solution, provided that (a) They consist of one or more of the such application be followed by a pota- following: ble water rinse and a 24-hour holding (1) Substances generally recognized period prior to consumption. However, by qualified experts as safe in food or for processed leafy vegetables (i.e., covered by prior sanctions for the use vegetables other than root, tuber, bulb, prescribed by this section. legume, fruiting, and cucurbit vegeta- (2) Substances listed in this para- bles) and vegetables in the Brassica graph (a)(2) of this section, subject to [Cole] family, application must be by any limitations imposed:

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Substances Limitations

Dimethylpolysiloxane (substantially free from hydrolyzable chlo- 10 parts per million in food, or at such level in a concentrated ride and alkoxy groups; no more than 18 percent loss in food that when prepared as directed on the labels, the food weight after heating 4 hours at 200 °C; viscosity 300 to 1,050 in its ready-for-consumption state will have not more than centistokes at 25 °C; refractive index 1.400–1.404 at 25 °C). 10 parts per million except as follows: Zero in milk; 110 parts per million in dry gelatin dessert mixes labeled for use whereby no more than 16 parts per million is present in the ready-to-serve dessert; 250 parts per million in salt labeled for cooking purposes, whereby no more than 10 parts per million is present in the cooked food. Formaldehyde ...... As a preservative in defoaming agents containing dimethylpolysiloxane, in an amount not exceeding 1.0 percent of the dimethylpolysiloxane content. a-Hydro-omega-hydroxy-poly (oxyethylene)/poly(oxypropylene) For use as prescribed in § 172.808(b)(3) of this chapter. (minimum 15 moles)/poly(oxyethylene) block copolymer (CAS Reg. No. 9003–11–6) as defined in § 172.808(a)(3) of this chapter. Polyacrylic acid, sodium salt ...... As a stabilizer and thickener in defoaming agents containing dimethylpolysiloxane in an amount reasonably required to accomplish the intended effect. Polyethylene glycol ...... As defined in § 172.820 of this chapter. Polyoxyethylene 40 monostearate ...... As defined in U.S.P. XVI. Polysorbate 60 ...... As defined in § 172.836 of this chapter. Polysorbate 65 ...... As defined in § 172.838 of this chapter. Propylene glycol alginate ...... As defined in § 172.858 of this chapter. Silicon dioxide ...... As defined in § 172.480 of this chapter. Sorbitan monostearate ...... As defined in § 172.842 of this chapter. White mineral oil: Conforming with §172.878 of this chapter ...... As a component of defoaming agents for use in wash water for sliced potatoes at a level not to exceed 0.008 percent of the wash water.

(3) Substances listed in this para- use in processing beet sugar and yeast, graph (a)(3), provided they are compo- and subject to any limitations im- nents of defoaming agents limited to posed:

Substances Limitations

Aluminum stearate ...... As defined in § 172.863 of this chapter. Butyl stearate. BHA ...... As an antioxidant, not to exceed 0.1 percent by weight of defoamer. BHT ...... Do. Calcium stearate ...... As defined in § 172.863 of this chapter. Fatty acids ...... As defined in § 172.860 of this chapter. Formaldehyde ...... As a preservative. Hydroxylated lecithin ...... As defined in § 172.814 of this chapter. Isopropyl alcohol. Magnesium stearate ...... As defined in § 172.863 of this chapter. Mineral oil: Conforming with § 172.878 of this chapter ...... Not more than 150 p.p.m. in yeast, measured as hydrocarbons. Odorless light petroleum hydrocarbons: Conforming with § 172.884 of this chapter. Petrolatum: Conforming with § 172.880 of this chapter ...... Petroleum wax: Conforming with § 172.886 of this chapter. Petroleum wax, synthetic. Polyethylene glycol (400)dioleate: Conforming with § 172.820(a)(2) of As an emulsifier not to exceed 10 percent by weight this chapter and providing the oleic acid used in the production of this of defoamer formulation. substance complies with § 172.860 or § 172.862 of this chapter. Synthetic isoparaffinic petroleum hydrocarbons: Conforming with § 172.882 of this chapter. Oleic acid derived from tall oil fatty acids ...... Complying with § 172.862 of this chapter. Oxystearin ...... As defined in § 172.818 of this chapter. Polyoxyethylene (600) dioleate. Polyoxyethylene (600) monoricinoleate. Polypropylene glycol ...... Molecular weight range, 1,200–3,000. Polysorbate 80 ...... As defined in § 172.840 of this chapter. Potassium stearate ...... As defined in § 172.863 of this chapter. Propylene glycol mono- and diesters of fats and fatty acids ...... As defined in § 172.856 of this chapter. Soybean oil fatty acids, hydroxylated. Tallow, hydrogenated, oxidized or sulfated. Tallow alcohol, hydrogenated.

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(4) The substances listed in this para- with the following prescribed condi- graph (a)(4), provided they are compo- tions: nents of defoaming agents limited to (a) The additive chlorofluorocarbon use in processing beet sugar only, and 113 has a purity of not less than 99.99 subject to the limitations imposed: percent.

Substances Limitations (b) The additive mixture is intended for use to quickly cool or crust-freeze n-Butoxypoly(oxyethylene)- Viscosity range, 4,850–5,350 chickens sealed in intact bags com- poly(oxypropylene)glycol. Saybolt Universal Seconds (SUS) at 37.8 °C (100 °F). posed of substances regulated in parts The viscosity range is de- 174, 175, 177, 178, and § 179.45 of this termined by the method chapter and conforming to any limita- ‘‘Viscosity Determination of n-butoxypoly(oxyethylene)- tions or specifications in such regula- poly(oxypropylene) glycol’’ tions. dated April 26, 1995, developed by Union Carbide [55 FR 8913, Mar. 9, 1990] Corp., P.O. Box 670, Bound Brook, NJ 08805, § 173.345 Chloropentafluoroethane. which is incorporated by reference in accordance The food additive with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the chloropentafluoroethane may be safely material incorporated by used in food in accordance with the fol- reference are available lowing prescribed conditions: from the Division of Petition Control, Center for Food (a) The food additive has a purity of Safety and Applied Nutri- not less than 99.97 percent, and con- tion (HFS–215), Food and tains not more than 200 parts per mil- Drug Administration, 5100 Paint Branch Pkwy., Col- lion saturated fluoro compounds and 10 lege Park, MD 20740, and parts per million unsaturated fluoro may be examined at the compounds as impurities. Center for Food Safety and Applied Nutrition’s Library, (b) The additive is used or intended 5100 Paint Branch Pkwy., for use alone or with one or more of the College Park, MD 20740, following substances: Carbon dioxide, or at the Office of the Fed- eral Register, 800 North nitrous oxide, propane, and Capitol St. NW., suite 700, octafluorocyclobutane complying with Washington, DC. § 173.360, as an aerating agent for Monoester of alpha-hydro- omega-hydroxy- foamed or sprayed food products, with poly(oxyethylene) any propellant effect being incidental poly(oxypropylene) and no more than is minimally nec- poly(oxyethylene) (15 mole minimum) blocked copoly- essary to achieve the aerating func- mer derived from low eru- tion, except that use is not permitted cic acid rapeseed oil. for those standardized foods that do (b) They are added in an amount not not provide for such use. in excess of that reasonably required to (c) To assure safe use of the additive inhibit foaming. (1) The label of the food additive container shall bear, in addition to the [42 FR 14526, Mar. 15, 1977, as amended at 43 other information required by the act, FR 2872, Jan. 20, 1978; 46 FR 30493, June 9, 1981; 46 FR 57476, Nov. 24, 1981; 60 FR 54036, the following: Oct. 19, 1995; 61 FR 632, Jan. 9, 1996; 63 FR (i) The name of the additive, 29134, May 28, 1998] chloropentafluoroethane. (ii) The percentage of the additive § 173.342 Chlorofluorocarbon 113 and present in the case of a mixture. perfluorohexane. (iii) The designation ‘‘food grade’’. A mixture of 99 percent (2) The label or labeling of the food chlorofluorocarbon 113 (1,1,2-trichloro- additive container shall bear adequate 1,2,2-trifluoroethane) (CAS Reg. No. 76– directions for use. 13–1, also known as fluorocarbon 113, CFC 113 and FC 113) and 1 percent [42 FR 14526, Mar. 15, 1977, as amended at 43 perfluorohexane (CAS Reg. No. 355–42– FR 11317, Mar. 17, 1978; 43 FR 14644, Apr. 7, 0) may be safely used in accordance 1978]

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§ 173.350 Combustion product gas. against isooctane of the same spectral purity in 5-centimeter cells. (This absorbance will The food additive combustion prod- be approximately 0.30.) uct gas may be safely used in the proc- Solvent. The solvent used is pure grade iso- essing and packaging of the foods des- octane having an ultraviolet absorbance not ignated in paragraph (c) of this section to exceed 0.05 measured against distilled for the purpose of removing and dis- water as a reference. Upon passage of puri- placing oxygen in accordance with the fied inert gas through some isooctane under following prescribed conditions: the identical conditions of the test, a low- ering of the absorbance value has been ob- (a) The food additive is manufactured served. The absorbance of isooctane to be by the controlled combustion in air of used in this procedure shall not be more than butane, propane, or natural gas. The 0.02 lower in the range 255 millimicrons to combustion equipment shall be pro- 310 millimicrons, inclusive, than that of the vided with an absorption-type filter ca- untreated solvent as measured in a 5-centi- pable of removing possible toxic impu- meter cell. If necessary to obtain the pre- rities, through which all gas used in scribed purities, the isooctane may be passed the treatment of food shall pass; and through activated silica gel. Apparatus. To assure reproducible results, with suitable controls to insure that the additive is passed into the isooctane so- any combustion products failing to lution through a gas-absorption train con- meet the specifications provided in this sisting of the following components and nec- section will be prevented from reaching essary connections: the food being treated. 1. A gas flow meter with a range up to 30 (b) The food additive meets the fol- liters per hour provided with a constant dif- lowing specifications: ferential relay or other device to maintain a (1) Carbon monoxide content not to constant flow rate independent of the input pressure. exceed 4.5 percent by volume. 2. An absorption apparatus consisting of an (2) The ultraviolet absorbance in iso- inlet gas dispersion tube inserted to the bot- octane solution in the range 255 milli- tom of a covered cylindrical vessel with a microns to 310 millimicrons not to ex- suitable outlet on the vessel for effluent gas. ceed one-third of the standard ref- The dimensions and arrangement of tube and erence absorbance when tested as de- vessel are such that the inlet tube introduces scribed in paragraph (e) of this section. the gas at a point not above 51⁄4 inches below (c) It is used or intended for use to the surface of the solvent through a sintered glass outlet. The dimensions of the vessel are displace or remove oxygen in the proc- such, and both inlet and vessel are so de- essing, storage, or packaging of bev- signed, that the gas can be bubbled through erage products and other food, except 60 milliliters of isooctane solvent at a rate fresh meats. up to 30 liters per hour without mechanical (d) To assure safe use of the additive loss of solvent. The level corresponding to 60 in addition to the other information re- milliliters should be marked on the vessel. quired by the act, the label or labeling 3. A cooling bath containing crushed ice of the combustion device shall bear and water to permit immersion of the absorption vessel at least to the solvent level adequate directions for use to provide a mark. combustion product gas that complies Caution. The various parts of the absorp- with the limitations prescribed in para- tion train must be connected by gas-tight graph (b) of this section, including in- tubing and joints composed of materials structions to assure proper filtration. which will neither remove components from (e) The food additive is tested for nor add components to the gas stream. The compliance with paragraph (b)(2) by gas source is connected in series to the flow- the following empirical method: rate device, the flow meter, and the absorption apparatus in that order. Ventilation Spectrophotometric measurements. All meas- should be provided for the effluent gases urements are made in an ultraviolet spectro- which may contain carbon monoxide. photometer in optical cells of 5 centimeters Sampling procedure. Immerse the gas-ab- in length, and in the range of 255 milli- sorption apparatus containing 60 milliliters microns to 310 millimicrons, under the same of isooctane in the coolant bath so that the instrumental conditions. The standard ref- solvent is completely immersed. Cool for at erence absorbance is the absorbance at 275 least 15 minutes and then pass 120 liters of millimicrons of a standard reference solution the test gas through the absorption train at of naphthalene (National Bureau of Stand- a rate of 30 liters per hour or less. Maintain ards Material No. 577 or equivalent in purity) the coolant bath at 0 °C throughout. Remove containing a concentration of 1.4 milligrams the absorption vessel from the bath, disper liter in purified isooctane, measured connect, and warm to room temperature.

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Add isooctane to bring the contents of the (i) The name of the additive, dichlo- absorption vessel to 60 milliliters, and mix. rodifluoromethane, with or without the Determine the absorbance of the solution in parenthetical name ‘‘Food Freezant the 5-centimeter cell in the range 255 millimicrons to 310 millimicrons, inclusive, com- 12’’. pared to isooctane. The absorbance of the so- (ii) The designation ‘‘food grade’’. lution of combustion product gas shall not (2) The label or labeling of the food exceed that of the isooctane solvent at any additive container shall bear adequate wavelength in the specified range by more than one-third of the standard reference ab- directions for use. sorbance. § 173.357 Materials used as fixing § 173.355 Dichlorodifluoromethane. agents in the immobilization of enzyme preparations. The food additive dichlorodifluoromethane may be safely used in Fixing agents may be safely used in food in accordance with the following the immobilization of enzyme prepara- prescribed conditions: tions in accordance with the following (a) The additive has a purity of not conditions: less than 99.97 percent. (a) The materials consist of one or (b) It is used or intended for use, in more of the following: accordance with good manufacturing (1) Substances generally recognized practice, as a direct-contact freezing as safe in food. agent for foods. (2) Substances identified in this sub- (c) To assure safe use of the additive: paragraph and subject to such limita- (1) The label of its container shall bear, in addition to the other informa- tions as are provided: tion required by the act, the following:

Substances Limitations

Acrylamide-acrylic acid resin: Complying May be used as a fixing material in the immobilization of glucose isomerase en- with § 173.5(a)(1) and (b) of this chapter. zyme preparations for use in the manufacture of high fructose corn syrup, in accordance with § 184.1372 of this chapter. Cellulose triacetate ...... May be used as a fixing material in the immobilization of lactase for use in reducing the lactose content of milk. Diethylaminoethyl-cellulose ...... May be used as a fixing material in the immobilization of glucose isomerase enzyme preparations for use in the manufacture of high fructose corn syrup, in accordance with § 184.1372 of this chapter. Dimethylamine-epichlorohydrin resin: May be used as a fixing material in the immobilization of glucose isomerase en- Complying with § 173.60(a) and (b) of zyme preparations for use in the manufacture of high fructose corn syrup, in ac- this chapter. cordance with § 184.1372 of this chapter. Glutaraldehyde ...... Do. Periodic acid (CAS Reg. No. 10450–60– 9)..

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Substances Limitations

Polyethylenimine reaction product with May be used as a fixing material in the immobilization of glucoamylase enzyme 1,2-dichloroethane (CAS Reg.No. preparations from Aspergillus niger for use in the manufacture of beer. 68130–97–2) is the reaction product of May be used as a fixing material in the immobilization of: homopolymerization of ethylenimine in 1. Glucose isomerase enzyme preparations for use in the manufacture of high fruc- aqueous hydrochloric acid at 100 °C tose corn syrup, in accordance with § 184.1372 of this chapter. and of cross-linking with 1,2- 2. Glucoamylase enzyme preparations from Aspergillus niger for use in the manu- dichloroethane. The finished polymer facture of beer. Residual ethylenimine in the finished polyethylenimine polymer has an average molecular weight of will be less than 1 part per million as determined by gas chromatography-mass 50,000 to 70,000 as determined by gel spectrometry. The residual ethylenimine is determined by an analytical method permeation chromatography. The analyt- entitled ‘‘Methodology for Ethylenimine Detection in Polyethylenimine,’’ which is ical method is entitled ‘‘Methodology for incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Molecular Weight Detection of Residual 1,2-dichloroethane in the finished polyethylenimine polymer will be less Polyethylenimine,’’ which is incorporated than 1 part per million as determined by gas chromatography. The residual 1,2- by reference in accordance with 5 dichloroethane is determined by an analytical method entitled, ‘‘Methodology for U.S.C. 552(a) and 1 CFR part 51. Cop- Ethylenedichloride Detection in Polyethylenimine,’’ which is incorporated by ref- ies may be obtained from the Division of erence in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be Petition Control, Center for Food Safety obtained from the Division of Petition Control, Center for Food Safety and Applied and Applied Nutrition (HFS–200), 5100 Nutrition (HFS–215), 5100 Paint Branch Pkwy., College Park, MD 20740, or may Paint Branch Pkwy., College Park, MD be examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 20740, and may be examined at the Paint Branch Pkwy., College Park, MD 20740, or the Office of the Federal Reg- Center for Food Safety and Applied Nu- ister, 800 North Capitol St. NW., suite 700, Washington, DC. trition’s Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Wash- ington, DC.

(b) The fixed enzyme preparation is (i) The name of the additive, washed to remove residues of the fixing octafluorocyclobutane. materials. (ii) The percentage of the additive present in the case of a mixture. [48 FR 5716, Feb. 8, 1983, as amended at 52 FR (iii) The designation ‘‘food grade’’. 39512, Oct. 22, 1987; 55 FR 12172, Apr. 2, 1990; (2) The label or labeling of the food 59 FR 36937, July 20, 1994; 61 FR 4873, Feb. 9, 1996; 61 FR 14245, Apr. 1, 1996; 67 FR 42716, additive container shall bear adequate June 25, 2002] directions for use.

§ 173.360 Octafluorocyclobutane. § 173.368 Ozone. Ozone (CAS Reg. No. 10028–15–6) may The food additive octafluorocyclo-bu- be safely used in the treatment, stor- tane may be safely used as a propellant age, and processing of foods, including and aerating agent in foamed or meat and poultry (unless such use is sprayed food products in accordance precluded by standards of identity in 9 with the following conditions: CFR part 319), in accordance with the (a) The food additive meets the fol- following prescribed conditions: lowing specifications: (a) The additive is an unstable, color- 99.99 percent octafluorocyclobutane. less gas with a pungent, characteristic Less than 0.1 part per million fluoroolefins, odor, which occurs freely in nature. It calculated as perfluoroisobutylene. is produced commercially by passing electrical discharges or ionizing radi- (b) The additive is used or intended ation through air or oxygen. for use alone or with one or more of the (b) The additive is used as an anti- following substances: Carbon dioxide, microbial agent as defined in nitrous oxide, and propane, as a propel- § 170.3(o)(2) of this chapter. lant and aerating agent for foamed or (c) The additive meets the specifica- sprayed food products, except for those tions for ozone in the Food Chemicals standardized foods that do not provide Codex, 4th ed. (1996), p. 277, which is infor such use. corporated by reference. The Director (c) To assure safe use of the additive: of the Office of the Federal Register (1) The label of the food additive con- approves this incorporation by ref- tainer shall bear, in addition to the erence in accordance with 5 U.S.C. other information required by the act, 552(a) and 1 CFR part 51. Copies are the following: available from the National Academy

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Press, 2101 Constitution Ave. NW., oxide is 110 ppm, and the maximum Washington, DC 20055, or may be exam- concentration of 1-hydroxyethylidene- ined at the Office of Premarket Ap- 1,1-diphosphonic acid (HEDP) is 13 ppm. proval (HFS–200), Center for Food Safe- (c) The concentrations of peroxyacids ty and Applied Nutrition, Food and and hydrogen peroxide in the additive Drug Administration, 5100 Paint are determined by a method entitled Branch Pkwy., College Park, MD 20740, ‘‘Hydrogen Peroxide and Peracid (as and the Office of the Federal Register, Peracetic Acid) Content,’’ July 26, 2000, 800 North Capitol St. NW., suite 700, developed by Ecolab, Inc., St. Paul, Washington, DC. MN, which is incorporated by ref- (d) The additive is used in contact erence. The concentration of 1- with food, including meat and poultry hydroxyethylidene-1,1-diphosphonic (unless such use is precluded by stand- acid is determined by a method enti- ards of identity in 9 CFR part 319 or 9 tled ‘‘Determination of 1- CFR part 381, subpart P), in the gas- hydroxyethylidene-1,1-diphosphonic eous or aqueous phase in accordance acid (HEDP) Peroxyacid/Peroxide-Con- with current industry standards of taining Solutions,’’ August 21, 2001, de- good manufacturing practice. veloped by Ecolab, Inc., St. Paul, MN, (e) When used on raw agricultural which is incorporated by reference. The commodities, the use is consistent with Director of the Office of the Federal section 201(q)(1)(B)(i) of the Federal Register approves these incorporations Food, Drug, and Cosmetic Act (the act) by reference in accordance with 5 and not applied for use under section U.S.C. 552(a) and 1 CFR part 51. You 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or may obtain copies of these methods (q)(1)(B)(i)(III) of the act. from the Division of Petition Review, [66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, Center for Food Safety and Applied Nu- 2002] trition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, § 173.370 Peroxyacids. MD 20740, or you may examine a copy Peroxyacids may be safely used in ac- at the Center for Food Safety and Ap- cordance with the following prescribed plied Nutrition’s Library, 5100 Paint conditions: Branch Pkwy., College Park, MD 20740, (a) The additive is a mixture of per- or at the Office of the Federal Register, oxyacetic acid, octanoic acid, acetic 800 North Capitol St. NW., suite 700, acid, hydrogen peroxide, Washington, DC. peroxyoctanoic acid, and 1- [65 FR 70660, Nov. 27, 2000, as amended at 66 hydroxyethylidene-1,1-diphosphonic FR 48208, Sept. 19, 2001; 67 FR 61784, Oct. 2, acid. 2002] (b)(1) The additive is used as an antimicrobial agent on meat carcasses, § 173.385 Sodium methyl sulfate. parts, trim, and organs in accordance Sodium methyl sulfate may be with current industry practice where present in pectin in accordance with the maximum concentration of the following conditions. peroxyacids is 220 parts per million (a) It is present as the result of (ppm) as peroxyacetic acid, and the methylation of pectin by sulfuric acid maximum concentration of hydrogen and methyl alcohol and subsequent peroxide is 75 ppm. treatment with sodium bicarbonate. (2) The additive is used as an anti- (b) It does not exceed 0.1 percent by microbial agent on poultry carcasses, weight of the pectin. poultry parts, and organs in accordance with current industry standards § 173.395 Trifluoromethane sulfonic of good manufacturing practice (unless acid. precluded by the U.S. Department of Trifluoromethane sulfonic acid has Agriculture’s standards of identity in 9 the empirical formula CF3SO3H (CAS CFR part 381, subpart P) where the Reg. No. 1493–13–6). The catalyst maximum concentration of (Trifluoromethane sulfonic acid) may peroxyacids is 220 parts per million safely be used in the production of (ppm) as peroxyacetic acid, the max- cocoa butter substitute from palm oil imum concentration of hydrogen per- (1-palmitoyl-2-oleoyl-3-stearin) (see

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§ 184.1259 of this chapter) in accordance ammonium chloride. The additive may with the following conditions: contain residues of isopropyl alcohol (a) The catalyst meets the following not in excess of 18 percent by weight specifications: when used as a processing solvent. Appearance, Clear liquid. (2) Ammonolysis of natural tallow Color, Colorless to amber. fatty acids to form amines that are Neutralization equivalent, 147–151. then reacted with 2-ethylhexanal, re- Water, 1 percent maximum. duced, methylated, and subsequently Fluoride ion, 0.03 percent maximum. reacted with methyl chloride to form Heavy metals (as Pb), 30 parts per million maximum. the quaternary ammonium compound Arsenic (as As), 3 parts per million max- known as dimethyl(2-ethylhexyl) hy- imum. drogenated tallow ammonium chloride (b) It is used at levels not to exceed and consisting primarily of dimethyl(2- 0.2 percent of the reaction mixture to ethylhexyl)octadecylammonium chlo- catalyze the directed esterification. ride and dimethyl(2-ethyl- (c) The esterification reaction is hexyl)hexadecylammonium chloride. quenched with steam and water and (b) The food additive described in the catalyst is removed with the aque- paragraph (a)(1) of this section con- ous phase. Final traces of catalyst are tains not more than a total of 2 percent removed by washing batches of the by weight of free amine and amine hy- product three times with an aqueous drochloride. The food additive de- solution of 0.5 percent sodium bicar- scribed in paragraph (a)(2) of this sec- bonate. tion contains not more than 3 percent (d) No residual catalyst may remain by weight, each, of free amine and in the product at a detection limit of amine hydrochloride as determined by 0.2 part per million fluoride as deter- A.O.C.S. method Te 3a–64, ‘‘Acid Value mined by the method described in ‘‘Of- and Free Amine Value of Fatty Quater- ficial Methods of Analysis of the Asso- nary Ammonium Chlorides,’’ 2d print- ciation of Official Analytical Chem- ing including additions and revisions ists,’’ sections 25.049–25.055, 13th Ed. 1990, which is incorporated by reference (1980), which is incorporated by refin accordance with 5 U.S.C. 552(a) and 1 erence. Copies may be obtained from CFR part 51. Copies are available from the Association of Official Analytical the Center for Food Safety and Applied Chemists International, 481 North Nutrition (HFS–200), Food and Drug Frederick Ave., suite 500, Gaithersburg, Administration, 5100 Paint Branch MD 20877–2504, or may be examined at Pkwy., College Park, MD 20740, and the Office of the Federal Register, 800 from the American Oil Chemists’ Soci- North Capitol Street, NW., suite 700, ety, P.O. Box 5037, Station A, Cham- Washington, DC 20408. paign, IL 61820, or available for inspec- [43 FR 54237, Nov. 11, 1978, as amended at 49 tion at the Office of the Federal Reg- FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, ister, 800 North Capitol Street, NW., 1989] suite 700, Washington, DC. § 173.400 Dimethyldialkylammonium (c) The food additive is used as a de- chloride. colorizing agent in the clarification of refinery sugar liquors under the fol- Dimethyldialkylammonium chloride lowing limitations: may be safely used in food in accordance with the following prescribed con- (1) The food additive described in ditions: paragraph (a)(1) of this section is added (a) The food additive is produced by only at the defecation/clarification one of the following methods: stage of sugar liquor refining in an (1) Ammonolysis of natural tallow amount not to exceed 700 parts per mil- fatty acids to form amines that are lion by weight of sugar solids. subsequently reacted with methyl chlo- (2) The food additive described in ride to form the quaternary ammonium paragraph (a)(2) of this section is used compounds consisting primarily of under the following conditions: dimethyldioctadecylammonium chlo- (i) The additive is adsorbed onto a ride and dimethyldihexadecyl- support column composed of suitable

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polymers that are regulated for con- more than reasonably required to ac- tact with aqueous food. Excess non- complish the intended physical or tech- adsorbed additive shall be rinsed away nical effect in the food-contact article; with potable water prior to passage of shall not exceed any prescribed limita- sugar liquor through the column. tions; and shall not be intended to ac- (ii) The residue of the additive in the complish any physical or technical ef- decolorized sugar liquor prior to crys- fect in the food itself, except as such tallization shall not exceed 1 part per may be permitted by regulations in million of sugar as determined by a parts 170 through 189 of this chapter. method entitled ‘‘Colorimetric Deter- mination of Residual Quaternary Am- (2) Any substance used as a compo- monium Compounds (Arquad HTL8) in nent of articles that contact food shall Sugar and Sugar Solutions,’’ June 13, be of a purity suitable for its intended 1990, which is incorporated by reference use. in accordance with 5 U.S.C. 552(a) and 1 (b) The existence in the subchapter B CFR part 51. Copies are available from of a regulation prescribing safe condi- the Center for Food Safety and Applied tions for the use of a substance as an Nutrition (HFS–200), Food and Drug article or component of articles that Administration, 5100 Paint Branch contact food shall not be construed to Pkwy., College Park, MD 20740, or relieve such use of the substance or ar- available for inspection at the Office of ticle from compliance with any other the Federal Register, 800 North Capitol provision of the Federal Food, Drug, Street, NW., suite 700, Washington, DC. and Cosmetic Act. For example, if a (d) To assure safe use of the additive, regulated food-packaging material the label and labeling of the additive were found on appropriate test to im- shall bear, in addition to other infor- part odor or taste to a specific food mation required by the Federal Food, product such as to render it unfit with- Drug, and Cosmetic Act, adequate directions to assure use in compliance in the meaning of section 402(a)(3) of with paragraph (c) of this section. the Act, the regulation would not be construed to relieve such use from [56 FR 42686, Aug. 29, 1991] compliance with section 402(a)(3). (c) The existence in this subchapter B PART 174—INDIRECT FOOD of a regulation prescribing safe condi- ADDITIVES: GENERAL tions for the use of a substance as an article or component of articles that Sec. contact food shall not be construed as 174.5 General provisions applicable to indi- implying that such substance may be rect food additives. 174.6 Threshold of regulation for substances safely used as a direct additive in food. used in food–contact articles. (d) Substances that under conditions AUTHORITY: 21 U.S.C. 321, 342, 348, 371. of good manufacturing practice may be safely used as components of articles § 174.5 General provisions applicable that contact food include the fol- to indirect food additives. lowing, subject to any prescribed limi- (a) Regulations prescribing condi- tations: tions under which food additive sub- (1) Substances generally recognized stances may be safely used predicate as safe in or on food. usage under conditions of good manu- (2) Substances generally recognized facturing practice. For the purpose of as safe for their intended use in food this part and parts 175, 176, and 177 of packaging. this chapter, good manufacturing prac- (3) Substances used in accordance tice shall be defined to include the fol- with a prior sanction or approval. lowing restrictions: (1) The quantity of any food additive (4) Substances permitted for use by substance that may be added to food as regulations in this part and parts 175, a result of use in articles that contact 176, 177, 178 and § 179.45 of this chapter. food shall not exceed, where no limits (5) Food contact substances used in are specified, that which results from accordance with an effective pre- use of the substance in an amount not market notification for a food contact

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substance (FCN) submitted under sec- EDITORIAL NOTE: Nomenclature changes to tion 409(h) of the act. part 175 appear at 61 FR 14482, Apr. 2, 1996, and 66 FR 56035, Nov. 6, 2001. [42 FR 14534, Mar. 15, 1977, as amended at 67 FR 35731, May 21, 2002] Subpart A [Reserved] § 174.6 Threshold of regulation for substances used in food-contact ar- Subpart B—Substances for Use ticles. Only as Components of Adhesives Substances used in food-contact articles (e.g., food-packaging or food-proc- § 175.105 Adhesives. essing equipment) that migrate, or that may be expected to migrate, into (a) Adhesives may be safely used as food at negligible levels may be re- components of articles intended for use viewed under § 170.39 of this chapter. in packaging, transporting, or holding The Food and Drug Administration food in accordance with the following will exempt substances whose uses it prescribed conditions: determines meet the criteria in § 170.39 (1) The adhesive is prepared from one of this chapter from regulation as food or more of the optional substances additives and, therefore, a food addi- named in paragraph (c) of this section, tive petition will not be required for subject to any prescribed limitations. the exempted use. (2) The adhesive is either separated from the food by a functional barrier or [60 FR 36596, July 17, 1995] used subject to the following additional limitations: PART 175—INDIRECT FOOD ADDI- (i) In dry foods. The quantity of adhe- TIVES: ADHESIVES AND COMPO- sive that contacts packaged dry food NENTS OF COATINGS shall not exceed the limits of good manufacturing practice. Subpart A [Reserved] (ii) In fatty and aqueous foods. (a) The quantity of adhesive that contacts Subpart B—Substances for Use Only as packaged fatty and aqueous foods shall Components of Adhesives not exceed the trace amount at seams Sec. and at the edge exposure between pack- 175.105 Adhesives. aging laminates that may occur within 175.125 Pressure-sensitive adhesives. the limits of good manufacturing practice. Subpart C—Substances for Use as (b) Under normal conditions of use Components of Coatings the packaging seams or laminates will 175.210 Acrylate ester copolymer coating. remain firmly bonded without visible 175.230 Hot-melt strippable food coatings. separation. 175.250 Paraffin (synthetic). (b) To assure safe usage of adhesives, 175.260 Partial phosphoric acid esters of pol- the label of the finished adhesive con- yester resins. 175.270 Poly(vinyl fluoride) resins. tainer shall bear the statement ‘‘food- 175.300 Resinous and polymeric coatings. packaging adhesive’’. 175.320 Resinous and polymeric coatings for (c) Subject to any limitation pre- polyolefin films. scribed in this section and in any other 175.350 Vinyl acetate/crotonic acid copoly- regulation promulgated under section mer. 409 of the Act which prescribes safe 175.360 Vinylidene chloride copolymer coatings for nylon film. conditions of use for substances that 175.365 Vinylidene chloride copolymer coat- may be employed as constituents of ad- ings for polycarbonate film. hesives, the optional substances used 175.380 Xylene-formaldehyde resins con- in the formulation of adhesives may in- densed with 4,4′-isopropylidenediphenol- clude the following: epichlorohydrin epoxy resins. (1) Substances generally recognized 175.390 Zinc-silicon dioxide matrix coatings. as safe for use in food or food pack- AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. aging. SOURCE: 42 FR 14534, Mar. 15, 1977, unless (2) Substances permitted for use in otherwise noted. adhesives by prior sanction or approval

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and employed under the specific condi- (5) Substances permitted for use in tions of use prescribed by such sanc- adhesives by other regulations in this tion or approval. subchapter and substances named in (3) Flavoring substances permitted this subparagraph: Provided, however, for use in food by regulations in this That any substance named in this part, provided that such flavoring subparagraph and covered by a specific stances are volatilized from the adhe- regulation in this subchapter, must sives during the packaging fabrication meet any specifications in such regula- process. tion. (4) Color additives approved for use in food.

Substances Limitations

Abietic acid. Acetone. Acetone-formaldehyde condensate (CAS Reg. No. 25619–09–4). Acetone-urea-formaldehyde resin. N-Acetyl ethanolamine. Acetyl tributyl citrate. Acetyl triethyl citrate. 2-Acrylamido-2-methyl-propanesulfonic acid, homopolymer, sodium salt (CAS Reg. No. 35641–59–9). Albumin, blood. (2-Alkenyl) succinic anhydrides in which the alkenyl groups are derived from olefins which contain not less than 78 percent C30 and higher groups (CAS Reg. No. 70983–55–0). 4-[2-[2-2-(Alkoxy (C12-C15) ethoxy) ethoxy]ethyl] disodium sulfosuccinate. 1-Alkyl (C6-C18) amino-3-amino-propane monoacetate. Alkylated (C4 and/or C8) phenols. Alkyl (C7-C12) benzene. Alkyl (C10-C20) dimethylbenzyl ammonium chloride. n-Alkyl(C12, C14, C16, or C18) dimethyl (ethylbenzyl) ammonium For use as preservative only. cyclohexylsulfamate. Alkyl ketene dimers as described in § 176.120 of this chapter. Alkyl (C7-C12) naphthalene. alpha Olefin sulfonate [alkyl group is in the range of C10-C18 with not less than 50 percent C14-C16], ammonium, calcium, magnesium, potassium, and sodium salts. 2-[(2-aminoethyl)amino]ethanol (CAS Reg. No. 111–41–1). 3-Aminopropanediol ...... For use only in the preparation of polyurethane resins. Aluminum. Aluminum acetate. Aluminum di(2-ethylhexoate). Aluminum potassium silicate. N-b-Aminoethyl-gamma-aminopropyl trimethoxysilane. 3-(Aminomethyl)-3,5,5-trimethylcyclohexylamine. Aminomethylpropanol. Ammonium benzoate ...... For use as preservative only. Ammonium bifluoride ...... For use only as bonding agent for aluminum foil, stabilizer or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesive. Ammonium borate. Ammonium citrate. Ammonium persulfate. Ammonium polyacrylate. Ammonium potassium hydrogen phosphate. Ammonium silico-fluoride ...... For use only as bonding agent for aluminum foil, stabilizer, or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesive. Ammonium sulfamate. Ammonium thiocyanate. Ammonium thiosulfate. Amyl acetate. Anhydroenneaheptitol. Animal glue as described in § 178.3120 of this chapter. 2-Anthraquinone sulfonic acid, sodium salt ...... For use only as polymerization-control agent. Antimony oxide. Asbestos. Asphalt, paraffinic and naphthenic.

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Substances Limitations

Azelaic acid. Azo-bis-isobutyronitrile. Balata rubber. Barium acetate. Barium peroxide. Barium sulfate. Bentonite. Benzene (benzol). 1,4-Benzenedicarboxylic acid, bis[2-(1,1-dimethylethyl)-6-[[3-(1,1- For use as a stabilizer. dimethylethyl)-2-hydroxy-5-methylphenyl]methyl]-4-methyl-phenyl]ester (CAS Reg. No. 57569–40–1). 1,2–Benzisothiazolin–3–one (CAS Registry No. 2634–33–5) ...... For use as preservative only. Benzothiazyldisulfide. p-Benzoxyphenol ...... For use as preservative only. Benzoyl peroxide. Benzyl alcohol. Benzyl benzoate. Benzyl bromoacetate ...... For use as preservative only. p-Benzyloxyphenol ...... Do. BHA (butylated hydroxyanisole). BHT (butylated hydroxytoluene). Bicyclo[2.2.1]hept-2-ene-6-methyl acrylate. 2-Biphenyl diphenyl phosphate. Bis(benzoate-O)(2-propanolato)aluminum (CAS Reg. No. 105442–85–1) For use only as a reactant in the preparation of polyester resins. 1,2-Bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)hy-drazine (CAS Reg. For use at a level not to exceed 2 percent by weight No. 32687–78–8). of the adhesive. 1,3-Bis(2-benzothiazolylmercaptomethyl) urea. 4,4′-Bis(a,a-dimethylbenzyl)diphenylamine. 2,6-Bis(1,1-dimethylethyl)-4-(1-methylpropyl)phenol (CAS Reg. No. For use as an antioxidant and/or stabilizer only. 17540–75–9). 2,6-Bis (1-methylheptadecyl)-p-cresol. 4-[[4, 6-Bis(octylthio)6-Bis(octylthio)6-Bis(octylthio)-s-triazin-2-yl]amino]- 2,6-di-tert-butylphenol (CAS Reg. No. 991–84–4). Bis(tri-n-butyltin) oxide ...... For use as preservative only. Bis(trichloromethyl)sulfone C.A. Registry No. 3064–70–8 ...... Do. Borax. Boric acid. 2-Bromo-2-nitro-1, 3-propanediol (CAS Reg. No. 52–51–7) ...... For use only as an antibacterial preservative. Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium salt (also For use as a surface active agent in adhesives. known as butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt [CAS Reg. No. 144093–88–9]).. 1,3-Butanediol. 1,4-Butanediol. 1,4-Butanediol modified with adipic acid. Butoxy polyethylene polyproplyene glycol (molecular weight 900–4,200). Butyl acetate. Butyl acetyl ricinoleate. Butyl alcohol. Butylated reaction product of p-cresol and dicyclopentadiene ...... As identified in § 178.2010(b) of this chapter. Butylated, styrenated cresols identified in § 178.2010(b) of this chapter. Butyl benzoate. Butyl benzyl phthalate. Butyldecyl phthalate ...... 1,3-Butylene glycoldiglycolic acid copolymer. tert-Butyl hydroperoxide. 4,4′-Butylidenebis(6-tert-butyl-m-cresol). Butyl lactate. Butyloctyl phthalate. p-tert-Butylphenyl salicylate. Butyl phthalate butyl glycolate. p-tert-Butylpyrocatechol ...... For use only as polymerization-control agent. Butyl ricinoleate. Butyl rubber polymer. Butyl stearate. Butyl titanate, polymerized. Butyraldehyde. Calcium ethyl acetoacetate. Calcium nitrate. Calcium metasilicate. Camphor. Camphor fatty acid esters. Candelilla wax. epsilon-Caprolactam-(ethylene-ethyl acrylate) graft polymer.

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Substances Limitations

Carbon black, channel process. Carbon disulfide-1,1′-methylenedipiperidine reaction product. Carbon tetrachloride. Carboxymethylcellulose. Castor oil, polyoxyethylated (4–84 moles ethylene oxide). Cellulose acetate butyrate. Cellulose acetate propionate. Ceresin wax (ozocerite). Cetyl alcohol. Chloracetamide. Chloral hydrate. Chlorinated liquid n-paraffins with chain lengths of C10-C17, containing 40–70 percent chlorine by weight. Chlorinated pyridine mixture with active ingredients consisting of 2,3,5,6- For use as preservative only. tetrachloro-4-(methylsulfonyl) pyridine, 2,3,5,6-tetrachloro-4- (methylsulfinyl) pyridine and pentachloropyridine. Chlorinated rubber polymer (natural rubber polymer containing approximately 67 percent chlorine). 1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride ...... For use as preservative only. Chlorobenzene. 4-Chloro-3,5-dimethylphenol (p-chloro-m-xylenol) ...... For use as preservative only. 4-Chloro-3-methylphenol ...... Do. 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172–55–4) and For use only as an antimicrobial agent in polymer 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682–20–4) mixture at a latex emulsions. ratio of 3 parts to 1 part, manufactured from methyl-3- mercaptopropionate (CAS Reg. No. 2935–90–2). The mixture may contain magnesium nitrate (CAS Reg. No. 10377–60–3) at a concentration equivalent to the isothiazolone active ingredients (weight/ weight). Chloroform. Chloroprene. Chromium caseinate. Chromium nitrate. Chromium potassium sulfate. Cobaltous acetate. Coconut fatty acid amine salt of tetrachlorophenol ...... For use as preservative only. Copal. Copper 8-quinolinolate ...... For use as preservative only. Coumarone-indene resin. Cresyl diphenyl phosphate. Cumene hydroperoxide. Cyanoguanidine. Cyclized rubber as identified in § 176.170(b)(2) of this chapter. Cyclohexane. 1,4-Cyclohexanedimethanoldibenzoate (CAS Reg. No. 35541–81–2). Cyclohexanol. Cyclohexanone resin. Cyclohexanone-formaldehyde condensate. N-Cyclohexyl p-toluene sulfonamide. (h5-Cyclopentadienyl)-(h6-isopropylbenzene)iron(II) hexafluorophosphate For use only as a photoinitiator. (CAS Reg. No. 32760–80–8). Damar. Defoaming agents as described in § 176.210 of this chapter. Dehydroacetic acid ...... Diacetone alcohol. Diacetyl peroxide. N,N′-Dialkoyl-4,4′-diaminodiphenylmethane mixtures where; the alkoyl groups are derived from marine fatty acids (C12-C24). 2,5-Di-tert-amylhydroquinone. Diamines derived from dimerized vegetable oil acids. Diaryl-p-phenylenediamine, where the aryl group may be phenyl, tolyl, or xylyl. 1,2–Dibromo–2,4–dicyanobutane (CAS Registry No. 3569–65–7) ...... For use as a preservative only. 2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No. 10222–01–2)...... For use as a preservative only. Di(butoxyethyl) phthalate. 2,5-Di-tert-butylhydroquinone. Dibutyl maleate. 2,6-Di-tert-butyl-4-methylphenol ...... For use as preservative only. Di(C7, C9-alkyl)adipate. Dibutyl phthalate. Dibutyl sebacate. Dibutyltin dilaurate for use only as a catalyst for polyurethane resins. 1,2-Dichloroethylene (mixed isomers). Dicumyl peroxide.

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Substances Limitations

Dicyclohexyl phthalate. Diethanolamine. Diethanolamine condensed with animal or vegetable fatty acids. Diethylamine. Diethylene glycol. Diethylene glycol adipic acid copolymer. Diethylene glycol dibenzoate. Diethylene glycol hydrogenated tallowate monoester. Diethylene glycol laurate. Diethylene glycol monobutyl ether. Diethylene glycol monobutyl ether acetate. Diethylene glycol monoethyl ether. Diethylene glycol monoethyl ether acetate. Diethylene glycol monomethyl ether. Diethylene glycol monooleate. Diethylene glycol monophenyl ether. Diethylene glycol copolymer of adipic acid and phthalic anhydride. Di(2-ethylhexyl) adipate. Di(2-ethylhexyl)hexahydrophthalate. Di(2-ethylhexyl)phthalate. Diethyl oxalate. Diethyl phthalate. Dihexyl phthalate. Dihydroabietylphthalate. Di(2-hydroxy-5-tert-butylphenyl) sulfide. 2,2′-Dihydroxy-5,5′-dichlorodiphenylmethane (dichlorophene). 4,5-Dihydroxy-2-imidazolidinone. 4-(Diiodomethylsulfonyl) toluene CA Registry No.: 20018–09–01 ...... For use as an antifungal preservative only. Diisobutyl adipate. Diisobutyl ketone. Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride. Diisobutyl phthalate. Diisodecyl adipate. Diisodecyl phthalate. Diisooctyl phthalate. Diisopropylbenzene hydroperoxide. N,N-Dimethylcyclohexylamine dibutyldithiocarbamate. Dimethyl formamide. Dimethyl hexynol. 2,2-Dimethyl-1,3-propanediol dibenzoate. Dimethyl octynediol. N-(1,1-dimethyl-3-oxobutyl) acrylamide. Dimethyl phthalate. 3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione ...... For use as preservative only. Di-b-naphthyl-p-phenylenediamine. 4,6-Dinonyl-o-cresol. Dinonylphenol. Di-n-octyldecyl adipate. Dioctyldiphenylamine. Dioctylphthalate. Dioctylsebacate. Dioxane. Dipentaerythritol pentastearate. Dipentamethylene-thiuram-tetrasulfide. Dipentene ...... Dipentene resins. Dipentene-beta-pinene-styrene resins ...... Dipentene–styrene resin (CAS Registry No. 64536–06–7). Diphenyl-2-ethylhexyl phosphate. Diphenyl, hydrogen ated. N,N′-Diphenyl-p-phenylenediamine. Diphenyl phthalate. 1,3-Diphenyl-2-thiourea. Dipropylene glycol. Dipropylene glycol dibenzoate. Dipropylene glycol monomethyl ether. Dipropylene glycol copolymer of adipic acid and phthalic anhydride. Disodium cyanodithioimidocarbonate. Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294–49–8). N,N′-Distearoylethylenediamine. Distearyl thiodipropionate. 3,5-Di-tert-butyl-4-hydroxyhydrocinnamic acid triester with 1,3,5-tris(2-hy- For use as antioxidant only. droxyethyl)-s-triazine-2,4,6(1H, 3H, 5H)-trione. 4,4′-Dithiodimorpholine.

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Substances Limitations

n-Dodecylmercaptan. tert-Dodecylmercaptan. Dodecylphenoxybenzene-disulfonic acid and/or its calcium, magnesium, and sodium salts. Elemi gum. Epichlorohydrin-4,4′-isopropylidenediphenol resin. Epichlorohydrin-4,4′-sec-butylidenediphenol resin. Epichlorohydrin-4,4′-isopropylidene-di-o-cresol resin. Epichlorohydrin-phenolformaldehyde resin. Erucamide (erucylamide). Ethanolamine. Ethoxylated primary linear alcohols of greater than 10 percent ethylene oxide by weight having molecular weights of 390 to 7,000 (CAS Reg. No. 97953–22–5). Ethoxypropanol butyl ether. Ethyl alcohol (ethanol). 5-Ethyl-1,3-diglycidyl-5-methylhydantoin (CAS Reg. No. 15336–82–0). Ethylene-acrylic acid-carbon monoxide copolymer (CAS Reg. No. 97756–27–9). Ethylene-acrylic acid copolymer, partial sodium salt containing no more than 20 percent acrylic acid by weight, and no more than 16 percent of the acrylic acid as the sodium salt (CAS Reg. No. 25750–82–7). Ethylenediamine. Ethylenediaminetetra-acetic acid, calcium, ferric, potassium, or sodium salts, single or mixed. Ethylene dichloride. Ethylene glycol. Ethylene glycol monobutyl ether. Ethylene glycol monobutyl ether acetate. Ethylene glycol monoethyl ether. Ethylene glycol monoethyl ether acetate. Ethylene glycol monoethyl ether ricinoleate. Ethylene glycol monomethyl ether. Ethylene glycol monophenyl ether. Ethylene-carbon monoxide copolymer (CAS Reg. No. 25052–62–4) containing not more than 30 weight percent of the units derived from carbon monoxide. Ethylene-maleic anhydride copolymer, ammonium or potassium salt. Ethylene-methacrylic acid copolymer partial salts: Ammonium, calcium, magnesium, sodium, and/or zinc. Ethylene-methacrylic acid-vinyl acetate copolymer partial salts: Ammo- nium, calcium, magnesium, sodium, and/or zinc. Ethylene-octene-1 copolymers containing not less than 70 weight percent ethylene (CAS Reg. No. 26221–73–8). Ethylene-propylene-dicyclopentadiene copolymer rubber. Ethylene, propylene, 1,4-hexadiene and 2,5-norbornadiene tetrapolymer. Ethylene-vinyl acetate carbon monoxide terpolymer (CAS Registry No. 26337–35–9) containing not more than 15 weight percent of units derived from carbon monoxide. 2,2′-Ethylidenebis (4,6-di-tert-butylphenol) (CAS Reg. No. 35958–30–6). Ethyl-p-hydroxybenzoate ...... For use as preservative only. Ethyl hydroxyethylcellulose. Ethyl lactate. 2,2′-Ethylidenebis(4,6-di-tert-butylphenyl)fluorophosphonite (CAS Reg. For use as an antioxidant and/or stabilizer only. No. 118337–09–0). Ethyl phthalyl ethyl glycolate. Ethyl-p-toluene sulfonamide ...... Fats and oils derived from animal or vegetable sources, and the hydrogenated, sulfated, or sulfonated forms of such fats and oils. Fatty acids derived from animal or vegetable fats and oils; and salts of such acids, single or mixed, as follows: Aluminum. Ammonium. Calcium. Magnesium. Potassium. Sodium. Zinc. Ferric chloride. Fluosilicic acid (hydrofluosilicic acid) ...... For use only as bonding agent for aluminum foil, stabilizer, or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesive. Formaldehyde.

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Substances Limitations

Formaldehyde o- and p-toluene sulfonamide. Formamide. Fumaratochromium (III) nitrate. Furfural. Furfuryl alcohol. Fumaric acid. gamma-Aminopropyltrimethoxysilane (CAS Reg. No. 13822–56–5). Glutaraldehyde. Glycerides, di- and monoesters. Glycerol polyoxypropylene triol, minimum average molecular weight 250 For use only in the preparation of polyester and poly- (CAS Reg. No. 25791–96–2). urethane resins in adhesives. Glyceryl borate (glycol boriborate resin). Glyceryl ester of damar, copal, elemi, and sandarac. Glyceryl monobutyl ricinoleate. Glyceryl monohydroxy stearate. Glyceryl monohydroxy tallowate. Glyceryl polyoxypropylene triol (average molecular weight 1,000). Glyceryl tribenzoate. Glycol diacetate. Glyoxal. Heptane. Hexamethylenetetramine. Hexane. Hexanetriols. Hexylene glycol. Hydroabietyl alcohol. Hydrocarbon resins (produced by polymerization of mixtures of mono- and di-unsaturated hydrocarbons of the aliphatic, alicyclic, and monobenzenoid type derived both from cracked petroleum and terpene stocks) (CAS Reg. No. 68239–99–6). Hydrocarbon resins (produced by the polymerization of styrene and alpha-methyl styrene), hydrogenated (CAS Reg. No. 68441–37–2). Hydrofluoric acid ...... For use only as bonding agent for aluminum foil, stabilizer, or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesive. Hydrogen peroxide. Hydrogenated dipentene resin (CAS Reg. No. 106168–39–2). Hydrogenated dipentene-styrene copolymer resin (CAS Reg. No. 106168–36–9). Hydrogenated-beta-pinene-alpha-pinene-dipentene copolymer resin (CAS Reg. No. 106168–37–0). a-Hydro-omega-hydroxypoly-(oxytetramethylene) ...... For use only in the preparation of polyurethane resins. Hydroquinone. Hydroquinone monobenzyl ether. Hydroquinone monoethyl ether. 2(2′-Hydroxy-3′,5′ di-tert-amylphenyl) benzotriazole. Hydroxyacetic acid. 7-Hydroxycoumarin. Hydroxyethylcellulose. 2–Hydroxy-1-[4-(2-hydroxyethoxy)phenyl]-2-methyl-1-propanone(CAS For use only as a photoinitiator at a level not to ex- Reg. No. 106797–53–9). ceed 5 percent by weight of the adhesive. 1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2 alkyl (C6-C17) imidazolinium chloride. Hydroxyethyldiethylenetriamine. b-Hydroxyethyl pyridinium 2-mercaptobenzothiazol. Hydroxyethyl starch. Hydroxyethylurea ...... Hydroxylamine sulfate. 5-Hydroxymethoxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, 5- For use only as an antibacterial preservative. hydroxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, and 5-hydroxypoly- [methyleneoxy]methyl-1-aza-3,7-dioxabicyclo[3.3.0] octane mixture. Hydroxypropyl methylcellulose. 2-(Hydroxymethyl)-2-methyl-1,3-propanediol tribenzoate. 2-Imidazolidinone. 3–Iodo–2–propynyl-N-butyl carbamate (CAS Reg. No. 55406–53–6) ...... For use only as an antifungal preservative. Iodoform ...... For use only as polymerization-control agent. Isoascorbic acid. Isobutyl alcohol (isobutanol). Isobutylene-isoprene copolymer. Isodecyl benzoate (CAS Reg. No. 131298–44–77). Isophorone. Isopropanolamine (mono-, di-, tri-).

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Substances Limitations

Isopropyl acetate. Isopropyl alcohol (isopropanol). Isopropyl-m- and p-cresol (thymol derived). 4,4′-Isopropylidenediphenol. 4,4′-Isopropylidenediphenol, polybutylated mixture ...... For use as preservative only. Isopropyl peroxydicarbonate. p-Isopropoxy diphenylamine. 4,4′-Isopropylidene-bis(p-phenyleneoxy)-di-2-propanol. Itaconic acid. Japan wax. Kerosene. Lauroyl peroxide. Lauroyl sulfate salts: Ammonium. Magnesium. Potassium. Sodium. Lauryl alcohol. Lauryl pyridinium 5-chloro-2-mercaptobenzothiazole. Lignin calcium sulfonate. Lignin sodium sulfonate. Linoleamide (linoleic acid amide). Magnesium fluoride ...... For use only as bonding agent for aluminum foil, stabilizer, or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesives. Magnesium glycerophosphate. Maleic acid. Maleic anhydride-diisobutylene copolymer, ammonium or sodium salt. Manganese acetate. Marine oil fatty acid soaps, hydrogenated. Melamine. Melamine-formaldehyde copolymer. 2-Mercaptobenzothiazole. 2-Mercaptobenzothiazole and dimethyl dithiocarbamic acid mixture, so- For use as preservative only. dium salt. 2-Mercaptobenzothiazole, sodium or zinc salt ...... For use as preservative only. Methacrylate-chromic chloride complex, ethyl or methyl ester. p-Menthane hydroperoxide. Methyl acetate. Methyl acetyl ricinoleate. Methyl alcohol (methanol). Methylcellulose. Methylene chloride. 4,4′-Methylenebis(2,6-di-tert-butylphenol). 2,2-Methylenebis (4-ethyl-6-tert-butylphenol). 2,2-Methylenebis (4-methyl-6-nonylphenol). 2,2-Methylenebis (4-methyl-6-tert-butylphenol). Methyl ethyl ketone. Methyl ethyl ketone-formaldehyde condensate. 2-Methylhexane. 1-Methyl-2-hydroxy-4-isopropyl benzene. Methyl isobutyl ketone. Methyl oleate. Methyl oleate-palmitate mixture. Methyl phthalyl ethyl glycolate. Methyl ricinoleate. Methyl salicylate. a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1 a methylstyrene to 3 vinyltoluene). Methyl tallowate. Mineral oil. Monochloracetic acid. Monooctyldiphenylamine. Montan wax. Morpholine. Myristic acid-chromic chloride complex. Myristyl alcohol. Naphtha. Naphthalene, monosulfonated. Naphthalene sulfonic acid-formaldehyde condensate, sodium salt. a-Naphthylamine. a,a′,a″,a″′-Neopentane tetrayltetrakis [omega-hydroxypoly (oxypropylene) (1–2 moles)], average molecular weight 400.

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Substances Limitations

Nitric acid. µ-Nitrobiphenyl. Nitrocellulose. 2-Nitropropane. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters; the nonyl group is a propylene trimer isomer and the poly (oxyethylene) content averages 6–9 moles or 50 moles. a(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of p-nonylphenol (nonyl group is a propylene trimer isomer) with an average of 1–40 moles of ethylene oxide. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) sulfate, ammonium salt: the nonyl group is a propylene trimer isomer and the poly (oxyethylene) content averages 9 or 30 moles. endo-cis-5-Norbornene-2,3-dicarboxylic anhydride. α-cis-9-Octadecenyl-omega-hydroxypoly (oxyethylene); the octadecenyl group is derived from oleyl alcohol and the poly (oxyethylene) content averages 20 moles. Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate. Octyl alcohol. Octyldecyl phthalate. Octylphenol. Octylphenoxyethanols. Octylphenoxypolyethoxy-polypropoxyethanol (13 moles of ethylene oxide and propylene oxide). Odorless light petroleum hydrocarbons. Oleamide (oleic acid amide). Oleic acid, sulfated. 2,2′-Oxamidobis[ethyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate] (CAS Reg. No. 70331–94–1). Oxazoline. a-(oxiranylmethyl)-w-(oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], For use as a reactant in the preparation of epoxy- (alternative name: epichlorohydrin-polypropylene glycol) (CAS Reg. based resins. No. 26142–30–3). 2,2’-[oxybis[(methyl-2,1-ethanediyl)-oxymethylene]]bisoxirane, (alternative For use as a reactant in the preparation of epoxy- name: epichlorohydrin-dipropylene glycol) (CAS Reg. No. 41638–13– based resins. 5). n-Oxydiethylene-benzothiazole. Palmitamide (palmitic acid amide). Paraffin (C12-C20) sulfonate. Paraformaldehyde. Pentachlorophenol. Pentaerythritol ester of maleic anhydride. Pentaerythritol monostearate ...... For use as preservative only. Pentaerythritol tetrabenzoate [CAS Registry No. 4196–86–5]. Pentaerythritol tetrastearate. 2,4-Pentanedione. Pentasodium diethylenetriaminepentaacetate (CAS Reg. No. 140–01–2). Perchloroethylene. Petrolatum. Petroleum hydrocarbon resin (cyclopentadiene type), hydrogenated. Petroleum hydrocarbon resin (produced by the catalytic polymerization and subsequent hydrogenation of styrene, vinyltoluene, and indene types from distillates of cracked petroleum stocks). Petroleum hydrocarbon resins (produced by the homo-and copolymerization of dienes and olefins of the aliphatic, alicyclic, and monobenzenoid arylalkene types from distillates of cracked petroleum stocks). Phenol ...... For use as preservative only. Phenol-coumarone-indene resin. Phenolic resins as described in § 175.300(b)(3)(vi). Phenothiazine ...... For use only as polymerization-control agent. Phenyl-b-naphthylamine (free of b-naphthylamine). o-Phenylphenol ...... For use as preservative only. o-Phthalic acid. Pimaric acid ...... Pine oil. Piperazine. Piperidinium pentamethylenedithiocarbamate. Poly(acrylamide-[2-acrylamide-2-methylpropylsulfonate]-dimethylidiallyl ammonium chloride) sodium salt (CAS Reg. No. 72275-68-4). Polyamides derived from reaction of one or more of the following acids with one or more of the following amines: Acids: Azelaic acid.

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Substances Limitations

Dimerized vegetable oil acids. Amines: Bis(hexamethylene) triamine and higher homologues. Diethylenetriamine. Diphenylamine. Ethylenediamine. Hexamethylenediamine. Poly(oxypropylene)diamine (weight average molecular weight 2010) (CAS Reg. No. 9046–10–0). Poly(oxypropylene)diamine (weight average molecular weight 440) (CAS Reg. No. 9046–10–0). Tetraethylenepentamine. Triethylenetetramine. Polybutene, hydrogenated. Polybutylene glycol (molecular weight 1,000). Poly [2(diethylamino) ethyl methacrylate] phosphate. Polyester of adipic acid, phthalic acid, and propylene glycol, terminated with butyl alcohol. Polyester of diglycolic acid and propylene glycol containing ethylene glycol monobutyl ether as a chain stopper. Polyester resins (including alkyd type), as the basic polymer, formed as esters when one or more of the following acids are made to react with one or more of the following alcohols: Acids: Azelaic acid. Dimethyl 1,4-cyclohexanedicarboxylate (CAS Reg. No. 94–60–0). Dimethyl-5-sulfoisophthalic acid (CAS Reg. No. 50975–82–1) and/or its sodium salt (CAS Reg. No. 3965–55–7). Polybasic and monobasic acids identified in § 175.300(b)(3)(vii)(a) and (b). 5-sulfo-1,3-benzenedicarboxylic acid, monosodium salt (CAS Reg. No. 6362–79–4). Tetrahydrophthalic acid. Alcohols: 1,4-Cyclohexanedimethanol. 2,2-Dimethyl-1,3-propanediol. 1,6-Hexanediol (CAS Reg. No. 629–11–8). Polyhydric and monohydric alcohols identified in § 175.300(b)(3)(vii)(c) and (d). Polyethyleneadipate modified with ethanolamine with the molar ratio of For use only in the preparation of polyurethan resins. the amine to the adipic acid less than 0.1 to 1. Polyethylene glycol (molecular weight 200–6,000). Polyethylene glycol mono-isotridecyl ether sulfate, sodium salt (CAS Reg. No. 150413–26–6). Polyethyleneglycol alkyl(C10-C12) ether sulfosuccinate, disodium salt (CAS Reg. No. 68954–91–6). Polyethylene, oxidized. Polyethylene resins, carboxyl modified, identified in § 177.1600 of this chapter. Polyethylenimine. Polyethylenimine-epichlorohydrin resins. Poly(ethyloxazoline) (CAS Reg. No. 25805-17-8). Polyisoprene. Polymeric esters of polyhydric alcohols and polycarboxylic acids prepared from glycerin and phthalic anhydride and modified with benzoic acid, castor oil, coconut oil, linseed oil, rosin, soybean oil, styrene, and vinyl toluene. Polymers: Homopolymers and copolymers of the following monomers:. Acrylamide. Acrylic acid. Acrylonitrile. Allylmethacrylate (CAS Reg. No. 00096–05–09). Butadiene. Butene. N-tert-Butylacrylamide. Butyl acrylate. 1,3-Butylene glycol dimethacrylate. Butyl methacrylate. Crotonic acid. Decyl acrylate. Diallyl fumarate. Diallyl maleate.

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Substances Limitations

Diallyl phthalate. Dibutyl fumarate. Dibutyl itaconate. Dibutyl maleate. Di(2-ethylhexyl) maleate. Dimethyl-a-methylstyrene. Dioctyl fumarate. Dioctyl maleate. Divinylbenzene. Ethyl acrylate. Ethylene. Ethylene cyanohydrin. 2-Ethylhexyl acrylate. Ethyl methacrylate. Fatty acids, C10-13-branched, vinyl esters (CAS Reg. No. 184785– 38–4). Fumaric acid and/or its methyl, ethyl, propyl, butyl, amyl hexyl, heptyl and octyl esters. Glycidyl methacrylate. 1–Hexene (CAS Reg. No. 592–41–6). 2-Hydroxyethyl acrylate. 2-Hydroxyethyl methacrylate. 2-Hydroxypropyl methacrylate. Isobutyl acrylate. Isobutylene. Itaconic acid. Maleic acid, diester with 2-hydroxyethanesulfonic acid, sodium salt. Maleic anhydride. Methacrylic acid. Methyl acrylate. N,N′-Methylenebisacrylamide. Methyl methacrylate. N-Methylolacrylamide. Methyl styrene. -Methyl styrene. Monoethyl maleate. Monomethyl maleate. Mono (2-ethylhexyl) maleate. 5-Norbornene-2 3-dicarboxylic acid, mono-n-butyl ester. 1-Octene (CAS Reg. No. 111–66–0). Propyl acrylate. Propylene. Styrene. Triallyl cyanurate. Vinyl acetate. Vinyl alcohol (from alcoholysis or hydrolysis of vinyl acetate units). Vinyl butyrate. Vinyl chloride. Vinyl crotonate. Vinyl ethyl ether. Vinyl hexoate. Vinylidene chloride. Vinyl methyl ether. Vinyl pelargonate. Vinyl propionate. Vinyl pyrrolidone. Vinyl stearate. Polyoxyalkylated-phenolic resin (phenolic resin obtained from formaldehyde plus butyl- and/or amylphenols, oxyalkylated with ethylene oxide and/or propylene oxide). Poly(oxycaproyl) diols and triols (minimum molecular weight 500). Polyoxyethylated (40 moles) tallow alcohol sulfate, sodium salt. Polyoxyethylene (20 mol)—anhydrous lanolin adduct. Polyoxyethylene (molecular weight 200) dibenzoate. Polyoxyethylene (molecular weight 200–600) esters of fatty acids derived from animal or vegetable fats and oils (including tall oil). Polyoxyethylene (15 moles) ester of rosin. Polyoxyethylene (4–5 moles) ether of phenol. Polyoxyethylene (25 moles)—glycerol adduct. Polyoxyethylene (40 moles) stearate. Polyoxyethylene (5–15 moles) tridecyl alcohol. Polyoxypropylene (3 moles) tridecyl alcohol sulfate. Polyoxypropylene (20 moles) butyl ether. Polyoxypropylene (40 moles) butyl ether.

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Substances Limitations

Polyoxypropylene (20 moles) oleate butyl ether. Polyoxypropylene-polyoxyethylene condensate (minimum molecular weight 1,900). Polypropylene glycol (minimum molecular weight 150). Polypropylene glycol (3–4 moles) triether with 2-ethyl-2-(hydroxymethyl)- 1,3-propane-diol, average molecular weight 730. Polypropylene glycol dibenzoate (CAS Reg. No. 72245–46–6) ...... For use as a plasticizer at levels not to exceed 20 percent by weight of the finished adhesive. Polypropylene, noncrystalline. Polysiloxanes: Diethyl polysiloxane. Dihydrogen polysiloxane. Dimethyl polysiloxane. Diphenyl polysiloxane. Ethyl hydrogen polysiloxane. Ethyl phenyl polysiloxane. Methyl ethyl polysiloxane. Methyl hydrogen polysiloxane. Methyl phenyl polysiloxane. Phenyl hydrogen polysiloxane. Polysorbate 60. Polysorbate 80. Polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate). Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate). Poly[styrene-co-disodium maleate-co-a-(p-nonyl-phenyl)-omega-(p-vinyl- benzyl)poly(oxyethylene)] terpolymer. Polytretrafluoroethylene. Polyurethane resins produced by: (1) reacting diisocyanates with one or more of the polyols or polyesters named in this paragraph, or (2) reacting the chloroformate derivatives of one or more of the polyols or polyesters named in this paragraph with one or more of the polyamines named in this paragraph, or (3) reacting toluene diisocyanate or 4,4′ methylenebis(cyclohexylisocyanate) (CAS Reg. No. 5124–30–1) with: (i) one or more of the polyols or polyesters named in this paragraph and with either N-methyldiethanolamine (CAS Reg. No. 105–59–9) and dimethyl sulfate (CAS Reg. No. 77–78–1) or dimethylolpropionic acid (CAS Reg. No. 4767–03–7) and triethylamine (CAS Reg. No. 121–44–8), or (ii) a fumaric acid-modified polypropylene glycol or fumaric acid-modified tripropylene glycol), triethylamine (CAS Reg. No. 107–15–3), and ethylenediamine (CAS Reg. No. 121–44–8), or (4) reacting meta-tetramethylxylene diisocyanate (CAS Reg. No. 2778–42–9) with one or more of the polyols and polyesters listed in this paragraph and with dimethylolpropionic acid (CAS Reg. No. 4767–03–7) and triethylamine (CAS Reg. No. 121–44–8), N-methyldiethanolamine (CAS Reg. No. 105–59–9), 2–dimethylaminoethanol (CAS Reg. No. 108–01–0), 2– dimethylamino–2–methyl–1–propanol (CAS Reg. No. 7005–47–2), and/or 2–amino–2–methyl–1–propanol (CAS Reg. No. 124–68–5). Polyvinyl alcohol modified so as to contain not more than 3 weight percent of comonomer units derived from 1-alkenes having 12 to 20 carbon atoms. Polyvinyl butyral. Polyvinyl formal. Potassium ferricyanide ...... For use only as polymerization-control agent. Potassium N-methyldithiocarbamate. Potassium pentachlorophenate ...... For use as preservative only. Potassium permanganate. Potassium persulfate. Potassium phosphates (mono-, di-, tribasic). Potassium tripolyphosphate. a, a′, a″-1,2,3-Propanetriyltris [omega-(2,3-epoxypropoxy) poly (oxypropylene) (24 moles)]. b-Propiolactone. Propyl alcohol (propanol). Propylene carbonate. Propylene glycol and p-p′-isopropylidenediphenol diether. Propylene glycol dibenzoate (CAS Reg. No. 19224–26–1) ...... For use as a plasticizer at levels not to exceed 20 percent by weight of the finished adhesive. Propylene glycol esters of coconut fatty acids. Propylene glycol monolaurate. Propylene glycol monomethyl ether. Propylene glycol monostearate. a, a′, a″-[Propylidynetris (methylene)] tris [omega-hydroxypoly (oxypropylene) (1.5 moles minimum)], minimum molecular weight 400.

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Substances Limitations

Quaternary ammonium chloride (hexadecyl, octadecyl derivative) ...... For use as preservative only. Rosin (wood, gum, and tall oil rosin), rosin dimers, decarboxylated rosin (including rosin oil, disproportionated rosin, and these substances as modified by one or more of the following reactants:. Alkyl (C1-C9) phenolformaldehyde. Ammonia. Ammonium caseinate-p-Cyclohexylphenolformaldehyde. Diethylene glycol. Dipentaerythritol. Ethylene glycol. Formaldehyde. Fumaric acid. Glycerin. Hydrogen. Isophthalic acid. 4,4′-Isopropylidenediphenol-epichlorohydrin (epoxy). 4,4′-Isopropylidenediphenol-formaldehyde. Maleic anhydride. Methyl alcohol. Pentaerythritol. Phthalic anhydride. Polyethylene glycol. Phenol-formaldehyde. Phenyl µ-cresol-formaldehyde. p-Phenylphenol-formaldehyde. Sulfuric acid. Triethylene glycol. Xylenol-formaldehyde. Rosin salts (salts of wood, gum, and tall oil rosin, and the dimers thereof, decarboxylated rosin disproportionated rosin, hydrogenated rosin): Aluminum. Ammonium. Calcium. Magnesium. Potassium. Sodium. Zinc. Rosin, gasoline-insoluble fraction. Rubber hydrochloride polymer. Rubber latex, natural. Salicylic acid ...... For use as preservative only. Sandarac. Sebacic acid. Shellac. Silicon dioxide as defined in § 172.480(a) of this chapter. Sodium alkyl (C2-C13.5 aliphatic) benezenesulfonate. Sodium aluminum pyrophosphate. Sodium aluminum sulfate. Sodium bisulfate. Sodium calcium silicate. Sodium capryl polyphosphate. Sodium carboxymethylcellulose. Sodium chlorate. Sodium chlorite. Sodium chromate. Sodium decylsulfate. Sodium dehydroacetate ...... For use as preservative only. Sodium di-(2-ethylhexoate). Sodium di-(2-ethylhexyl) pyrophosphate. Sodium dihexylsulfosuccinate. Sodium dissobutylphenoxydiethoxyethyl sulfonate. Sodium diisobutylphenoxymonoethoxyethyl sulfonate. Sodium diisopropyl- and triisopropylnaphthalenesulfonate. Sodium dimethyldithiocarbamate. Sodium dioctylsulfosuccinate. Sodium n-dodecylpolyethoxy (50 moles) sulfate. Sodium ethylene ether of nonylphenol sulfate. Sodium 2-ethylhexyl sulfate. Sodium fluoride ...... For use only as bonding agent for aluminum foil, stabilizer, or preservative. Total fluoride for all sources not to exceed 1 percent by weight of the finished adhesive. Sodium formaldehyde sulfoxylate. Sodium formate.

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Substances Limitations

Sodium heptadecylsulfate. Sodium hypochlorite. Sodium isododecylphenoxypolyethoxy (40 moles) sulfate. Sodium N-lauroyl sarcosinate. Sodium metaborate. Sodium a-naphthalene sulfonate. Sodium nitrate. Sodium nitrite. Sodium oleoyl isopropanolamide sulfosuccinate. Sodium pentachlorophenate ...... For use as preservative only. Sodium perborate. Sodium persulfate. Sodium µ-phenylphenate ...... For use as preservative only. Sodium polyacrylate. Sodium polymethacrylate. Sodium polystyrene sulfonate. Sodium salicylate ...... For use as preservative only. Sodium salt of 1-hydroxy 2(1H)-pyridine thione ...... Do. Sodium tetradecylsulfate. Sodium thiocyanate. Sodium bis-tridecylsulfosuccinate. Sodium xylene sulfonate. Sorbitan monooleate. Sorbitan monostearate. Soybean oil, epoxidized. Spermaceti wax. Sperm oil wax. Stannous 2-ethylhexanoate ...... For use only as a catalyst for polyurethane resins. Stannous stearate. Starch hydrolysates. Starch or starch modified by one or more of the treatments described in §§ 172.892 and 178.3520 of this chapter. Starch, reacted with a urea-formaldehyde resin. Starch, reacted with formaldehyde. Stearamide (stearic acid amide). Stearic acid. Stearic acid-chromic chloride complex. Stearyl-cetyl alcohol, technical grade, approximately 65 percent–80 percent stearyl and 20 percent–35 percent cetyl. Strontium salicylate. Styrenated phenol. Styrene block polymers with 1,3-butadiene. Styrene-maleic anhydride copolymer, ammonium or potassium salt. Styrene-maleic anhydride copolymer (partially methylated) sodium salt. Styrene-methacrylic acid copolymer, potassium salt. Sucrose acetate isobutyrate. Sucrose benzoate. Sucrose octaacetate. 2–sulfoethyl methacrylate (CAS Registry No. 10595–80–9) ...... For use at levels not to exceed 2 percent by weight of the dry adhesive. a-Sulfo-omega-(dodecyloxy)poly (oxyethylene), ammonium salt. Sulfonated octadecylene (sodium form). Sulfosuccinic acid 4-ester with polyethylene glycol dodecyl ether disodium salt (alcohol moiety produced by condensation of 1 mole of n- dodecyl alcohol and an average of 5–6 moles of ethylene oxide, Chemical Abstracts Service Registry No. 039354–45–5). Sulfosuccinic acid 4-ester with polyethylene glycol nonylphenyl ether, disodium salt (alcohol moiety produced by condensation of 1 mole of nonylphenol and an average of 9–10 moles of ethylene oxide) (CAS Reg. No. 9040–38–4). Sulfur. Synthetic primary linear aliphatic alcohols whose weight average molecular weight is greater than 400 (CAS Reg. No. 71750–71–5). Synthetic wax polymer as described in § 176.170(a)(5) of this chapter. Tall oil. Tall oil fatty acids, linoleic and oleic. Tall oil fatty acid methyl ester. Tall oil, methyl ester. Tall oil pitch. Tall oil soaps. Tallow alcohol (hydrogenated). Tallow amine, secondary (hexadecyl, octadecyl), of hard tallow. Tallow, blown (oxidized). Tallow, propylene glycol ester.

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Substances Limitations

Terpene resins (a-and b-pinene) homopolymers, copolymers, and condensates with phenol, formaldehyde, coumarone, and/or indene. Terphenyl. Terphenyl, hydrogenated. Terpineol. Tetraethylene pentamine. Tetraethylthiuram disulfide. Tetrahydrofuran. Tetrahydrofurfuryl alcohol. Tetra-isopropyl titanate. Tetrakis[methylene (3,5-di-tert-butyl-4-hydroxy-hydro-cinnamate)] methane. A[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxypoly-(oxyethylene) produced by the condensation of 1 mole of p-(1,1,3,3-tetramethylbutyl) phenol with an average of 1–40 moles of ethylene oxide. A-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxy-poly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and their sodium, potassium, and ammonium salts having a poly(oxyethylene) content averaging 6–9 or 40 moles. Tetramethyl decanediol. Tetramethyl decynediol. Tetramethyl decynediol plus 1–30 moles of ethylene oxide. Tetramethylthiuram monosulfide. Tetrasodium N-(1,2-dicarboxyethyl)N-octadecylsulfosuccinamate. 4,4′-Thiobis-6-tert-butyl-m-cresol. Thiodiethylene-bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate). 2,2′-(2,5-Thiophenediyl) bis[5-tert-butylbenzoxazole]. Thiram. Thymol ...... For use as preservative only. Titanium dioxide. Titanium dioxide-barium sulfate. Titanium dioxide-calcium sulfate. Titanium dioxide-magnesium silicate. Toluene. Toluene 2,4-diisocyanate. Toluene 2,6-diisocyanate. o- and p-Toluene ethyl sulfonamide. o- and p-Toluene sulfonamide. p-Toluene sulfonic acid. p-(p′-Toluene-sulfonylamide)-diphenylamide. Triazine-formaldehyde resins as described in § 175.300(b)(3)(xiii). Tributoxyethyl phosphate. Tributylcitrate. Tri-tert-butyl-p-phenyl phenol ...... For use as preservative only. Tributyl phosphate. Tributyltin chloride complex of ethylene oxide condensate of For use as preservative only. dehydroabietylamine. Tri-n-butyltin acetate ...... For use as preservative only. Tri-n-butyltin neodecanoate ...... Do. 1,1,1-Trichloroethane. 1,1,2-Trichloroethane. Trichloroethylene. Tri-b-chloroethylphosphate. Tridecyl alcohol. Triethanolamine. 3-(Triethoxysilyl) propylamine. Triethylene glycol. Triethylene glycol dibenzoate. Triethylene glycol di(2-ethylhexoate). Triethylene glycol polyester of benzoic acid and phthalic acid. Triethylhexyl phosphate. Triethylphosphate. 2,4,5-Trihydroxy butyrophenone. Triisopropanolamine. Trimethylol propane. 2,2,4-Trimethylpentanediol-1,3-diisobutyrate. Trimeric aromatic amine resin from diphenylamine and acetone of molecular weight approximately 500. Tri(nonylphenyl) phosphite-formaldehyde resins ...... As identified in § 177.2600(c)(4)(iii) of this chapter. For use only as a stabilizer. Triphenylphosphate. Tripropylene glycol monomethyl ether. 1,3,5-Tris (3,5-di-tert-butyl-4-hydroxy-benzyl)-triazine-2,4,6 (1H,3H,5H)- trione.

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Substances Limitations

Tris (p-tertiary butyl phenyl) phosphate. Tris(2-methyl-4-hydroxy-5-tert-butyl-phenyl)butane. Trisodium N-hydroxyethylethylenediaminetriacetate (CAS Reg. No. 139– 89–9). Turpentine. Urea-formaldehyde resins as described in § 175.300(b)(3)(xii). Vegetable oil, sulfonated or sulfated, potassium salt. Vinyl acetate-maleic anhydride copolymer, sodium salt. Waxes, petroleum. Wax, petroleum, chlorinated (40% to 70% chlorine). Waxes, synthetic paraffin (Fischer-Tropsch process). 3-(2-Xenolyl)-1,2-epoxypropane. Xylene. Xylene (or toluene) alkylated with dicyclopentadiene. Zein. Zinc acetate. Zinc ammonium chloride. Zinc dibenzyl dithiocarbamate. Zinc dibutyldithiocarbamate. Zinc diethyldithiocarbamate. Zinc di(2-ethylhexoate). Zinc formaldehyde sulfoxylate. Zinc naphthenate and dehydroabietylamine mixture. Zinc nitrate. Zinc orthophosphate. Zinc resinate. Zinc sulfide. Zineb (zinc ethylenebis-dithiocarbamate). Ziram (zinc dimethyldithiocarbamate).

[42 FR 14534, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 175.105, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§ 175.125 Pressure-sensitive adhesives. (5) Polyethylene, oxidized; complying with the identity prescribed in Pressure-sensitive adhesives may be § 177.1620(a) of this chapter. safely used as the food-contact surface (6) 4-[[4, 6-Bis(octylthio)-s-triazin-2- of labels and/or tapes applied to food, yl]amino]-2,6-di-tert-butylphenol (CAS in accordance with the following pre- Reg. No. 991–84–4) as an antioxidant/ scribed conditions: stabilizer at a level not to exceed 1.5 (a) Pressure-sensitive adhesives pre- percent by weight of the finished pres- pared from one or a mixture of two or sure-sensitive adhesive. more of the substances listed in this (7) 2,2′-(2,5-Thiophenediyl)-bis(5-tert- paragraph may be used as the food-con- butylbenzoxazole) (CAS Reg. No. 7128– tact surface of labels and/or tapes ap- 64–5) as an optical brightener at a level plied to poultry, dry food, and proc- not to exceed 0.05 percent by weight of essed, frozen, dried, or partially dehy- the finished pressure-sensitive adhe- drated fruits or vegetables. sive. (1) Substances generally recognized (8) 2-Hydroxy-1-[4-(2-hydroxyethoxy) as safe in food. phenyl]-2-methyl-1-propanone (CAS (2) Substances used in accordance Reg. No. 106797–53–9) as a photoinitiator with a prior sanction or approval. at a level not to exceed 5 percent by (3) Color additives listed for use in or weight of the pressure-sensitive adhe- on food in parts 73 and 74 of this chap- sive. ter. (9) Butanedioic acid, sulfo-1,4-di-(C9- (4) Substances identified in § 172.615 of C11 alkyl) ester, ammonium salt (also this chapter other than substances known as butanedioic acid sulfo-1, 4- used in accordance with paragraph diisodecyl ester, ammonium salt [CAS (a)(2) of this section. Reg. No. 144093–88–9]) as a surface active agent at a level not to exceed 3.0

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percent by weight of the finished pres- the provisions of § 180.22 of this chap- sure-sensitive adhesive. ter. (b) Pressure-sensitive adhesives pre- [42 FR 14534, Mar. 15, 1977, as amended at 42 pared from one or a mixture of two or FR 15674, Mar. 22, 1977; 48 FR 15617, Apr. 12, more of the substances listed in this 1983; 63 FR 3464, Jan. 23, 1998; 63 FR 51528, paragraph may be used as the food-con- Sept. 28, 1998; 64 FR 48291, Sept. 3, 1999] tact surface of labels and/or tapes applied to raw fruit and raw vegetables. Subpart C—Substances for Use as (1) Substances listed in paragraphs Components of Coatings (a)(1), (a)(2), (a)(3), (a)(5), (a)(6), (a)(7), (a)(8), and (a)(9) of this section, and § 175.210 Acrylate ester copolymer those substances prescribed by para- coating. graph (a)(4) of this section that are not Acrylate ester copolymer coating identified in paragraph (b)(2) of this may safely be used as a food-contact section. surface of articles intended for pack- (2) Substances identified in this sub- aging and holding food, including heat- paragraph and subject to the limita- ing of prepared food, subject to the pro- tions provided: visions of this section: BHA. (a) The acrylate ester copolymer is a BHT. fully polymerized copolymer of ethyl Butadiene-acrylonitrile copolymer. acrylate, methyl methacrylate, and Butadiene-acrylonitrile-styrene copolymer. methacrylic acid applied in emulsion Butadiene-styrene copolymer. form to molded virgin fiber and heat- Butyl rubber. cured to an insoluble resin. Butylated reaction product of p-cresol and (b) Optional substances used in the dicyclopentadiene produced by reacting p- preparation of the polymer and in the cresol and dicyclopentadiene in an approxi- preparation and application of the mate mole ratio of 1.5 to 1.0, respectively, emulsion may include substances followed by alkylation with isobutylene so that the butyl content of the final product named in this paragraph, in an amount is not less than 18 percent, for use at levels not to exceed that required to accom- not to exceed 1.0 percent by weight of the plish the desired technical effect and adhesive formulation. subject to any limitation prescribed: Chlorinated natural rubber. Provided, however, That any substance Isobutylene-styrene copolymer. named in this paragraph and covered Petrolatum. by a specific regulation in subchapter Polybutene-1. B of this chapter must meet any speci- Polybutene, hydrogenated; complying with fications in such regulation. the identity prescribed under § 178.3740(b) of this chapter. List of substances Limitations Polyisobutylene. cis-1,4-Polyisoprene. Aluminum stearate. Ammonium lauryl sulfate. Polystyrene. Borax ...... Not to exceed the Propyl gallate. amount required as a Rapeseed oil, vulcanized. preservative in emul- Rosins and rosin derivatives as provided in sion defoamer. § 178.3870 of this chapter. Disodium hydrogen phosphate ..... Do. Rubber hydrochloride. Formaldehyde. Glyceryl monostearate. Rubber (natural latex solids or crepe, Methyl cellulose. smoked or unsmoked). Mineral oil. Terpene resins (a- and b-pinene), Paraffin wax. homopolymers, copolymers, and conden- Potassium hydroxide. sates with phenol, formaldehyde, cou- Potassium persulfate. marone, and/or indene. Tallow. Tetrasodium pyrophosphate. Tetrasodium ethylenediaminetetraacetate. Titanium dioxide. Tri(mixed mono- and dinonylphenyl) phosphite (which may contain not more (c) The coating in the form in which than 1 percent by weight of it contacts food meets the following triisopropanolamine). tests: (c) Acrylonitrile copolymers identi- (1) An appropriate sample when ex- fied in this section shall comply with posed to distilled water at 212 °F for 30

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minutes shall yield total chloroform- (b) Synthetic paraffin shall conform soluble extractables not to exceed 0.5 to the following specifications: milligram per square inch. (1) Congealing point. There is no speci- (2) An appropriate sample when ex- fication for the congealing point of posed to n-heptane at 120 °F for 30 min- synthetic paraffin components, except utes shall yield total chloroform-solu- those components that have a con- ble extractables not to exceed 0.5 milli- gealing point below 50 °C when used in gram per square inch. contact with food Types III, IVA, V, § 175.230 Hot-melt strippable food VIIA, and IX identified in table 1 of coatings. § 176.170(c) of this chapter and under Hot-melt strippable food coatings conditions of use E, F, and G described may be safely applied to food, subject in table 2 of § 176.170(c) of this chapter to the provisions of this section. shall be limited to a concentration not (a) The coatings are applied to and exceeding 15 percent by weight of the used as removable coatings for food. finished coating. The congealing point (b) The coatings may be prepared, as shall be determined by ASTM method mixtures, from the following sub- D938–71 (Reapproved 1981), ‘‘Standard stances: Test Method for Congealing Point of (1) Substances generally recognized Petroleum Waxes, Including Petro- as safe in food. latum,’’ which is incorporated by ref- (2) Substances identified in this sub- erence. Copies may be obtained from paragraph. the American Society for Testing Ma- List of substances Limitations terials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office Acetylated monoglycerides ...... Complying with 172.828 of the Federal Register, 800 North Cap- of this chapter. Cellulose acetate butyrate. itol Street, NW., suite 700, Washington, Cellulose acetate propionate. DC 20408. Mineral oil, white ...... For use only as a component of hot-melt (2) Oil content. The substance has an strippable food coat- oil content not exceeding 2.5 percent as ings applied to frozen determined by ASTM method D721–56T, meats and complying with § 172.878 of this ‘‘Tentative Method of Test for Oil Con- chapter. tent of Petroleum Waxes’’ (Revised 1956), which is incorporated by ref- § 175.250 Paraffin (synthetic). erence. See paragraph (b)(1) of this sec- Synthetic paraffin may be safely tion for availability of the incorpora- used as an impregnant in, coating on, tion by reference. or component of coatings on articles (3) Absorptivity. The substance has an used in producing, manufacturing, absorptivity at 290 millimicrons in packing, processing, preparing, treat- decahydronaphthalene at 88 °C not ex- ing, packaging, transporting, or hold- ceeding 0.01 as determined by ASTM ing food in accordance with the fol- method E131–81a, ‘‘Standard Defini- lowing prescribed conditions: tions of Terms and Symbols Relating (a) The additive is synthesized by the to Molecular-Spectroscopy,’’ which is Fischer-Tropsch process from carbon incorporated by reference. See para- monoxide and hydrogen, which are cat- graph (b)(1) of this section for avail- alytically converted to a mixture of ability of the incorporation by ref- paraffin hydrocarbons. Lower molec- erence. ular-weight fractions are removed by (c) The provisions of this section are distillation. The residue is hydro- not applicable to synthetic paraffin genated and may be further treated by used in food-packaging adhesives com- percolation through activated char- plying with § 175.105. coal. This mixture can be fractionated into its components by a solvent sepa- [42 FR 14534, Mar. 15, 1977, as amended at 47 ration method, using synthetic FR 11839, Mar. 19, 1982; 49 FR 10106, Mar. 19, isoparaffinic petroleum hydrocarbons 1984; 51 FR 47010, Dec. 30, 1986; 60 FR 39645, complying with § 178.3530 of this chap- Aug. 3, 1995] ter.

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§ 175.260 Partial phosphoric acid reference. Copies may be obtained from esters of polyester resins. the American Society for Testing Ma- Partial phosphoric acid esters of pol- terials, 1916 Race St., Philadelphia, PA yester resins identified in this section 19103, or may be examined at the Office and applied on aluminum may be safely of the Federal Register, 800 North Cap- used as food-contact coatings, in ac- itol Street, NW., suite 700, Washington, cordance with the following prescribed DC 20408. conditions: (1) Solvent. N,N-Dimethylacetamide, (a) For the purpose of this section, technical grade. partial phosphoric acid esters of poly- (2) Solution. Powdered resin and sol- ester resins are prepared by the reac- vent are heated at 120 °C until the resin tion of trimellitic anhydride with 2,2- is dissolved. dimethyl-1,3-propanediol followed by (3) Temperature. Flow times of the reaction of the resin thus produced solvent and solution are determined at with phosphoric acid anhydride to 110 °C. produce a resin having an acid number (4) Viscometer. Cannon-Ubbelohde size of 81 to 98 and a phosphorus content of 50 semimicro dilution viscometer (or 4.05 to 4.65 percent by weight. equivalent). (b) The coating is chemically bonded (5) Calculation. The calculation meth- to the metal and cured at temperatures od used is that described in appendix X exceeding 450 °F. 1.3 (ASTM method D1243–79, ‘‘Standard (c) The finished food-contact coating, Test Method for Dilute Solution Vis- when extracted with the solvent or sol- cosity of Vinyl Chloride Polymers,’’ vents characterizing the type of food which is incorporated by reference; see and under the conditions of time and paragraph (b) of this section for avail- temperature characterizing the condi- ability of the incorporation by ref- tions of its intended use, as determined erence) with the reduced viscosity de- from tables 1 and 2 of § 175.300(d), yields termined for three concentration levels total extractives in each extracting not greater than 0.5 gram per deciliter solvent not to exceed 0.3 milligrams and extrapolated to zero concentration per square inch of food-contact surface, for intrinsic viscosity. The following as determined by the methods de- formula is used for determining re- scribed in § 175.300(e), and the coating duced viscosity: yields 2,2-dimethyl-1,3-propanediol in each extracting solvent not to exceed Reduced viscosity in terms tto− 0.3 micrograms per square inch of food- = contact surface. In testing the finished of deciliters per gram to× c food-contact articles, a separate test where: sample is to be used for each required t=Solution efflux time. extracting solvent. to=Solvent efflux time. c=Concentration of solution in terms of § 175.270 Poly(vinyl fluoride) resins. grams per deciliter. Poly(vinyl fluoride) resins identified [42 FR 14534, Mar. 15, 1977, as amended at 47 in this section may be safely used as FR 11839, Mar. 19, 1982; 49 FR 10107, Mar. 19, components of food-contact coatings 1984] for containers having a capacity of not less than 5 gallons, subject to the pro- § 175.300 Resinous and polymeric coat- visions of this section. ings. (a) For the purpose of this section, Resinous and polymeric coatings poly(vinyl fluoride) resins consist of may be safely used as the food-contact basic resins produced by the polym- surface of articles intended for use in erization of vinyl fluoride. producing, manufacturing, packing, (b) The poly(vinyl fluoride) basic res- processing, preparing, treating, pack- ins have an intrinsic viscosity of not aging, transporting, or holding food, in less than 0.75 deciliter per gram as de- accordance with the following pre- termined by ASTM method D1243–79, scribed conditions: ‘‘Standard Test Method for Dilute So- (a) The coating is applied as a contin- lution Viscosity of Vinyl Chloride uous film or enamel over a metal sub- Polymers,’’ which is incorporated by strate, or the coating is intended for

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repeated food-contact use and is ap- solvent extraction, or modified by com- plied to any suitable substrate as a bination with maleic anhydride. continuous film or enamel that serves (ii) Reconstituted oils from as a functional barrier between the triglycerides or fatty acids derived food and the substrate. The coating is from the oils listed in paragraph characterized by one or more of the fol- (b)(3)(i) of this section to form esters lowing descriptions: with: (1) Coatings cured by oxidation. Butylene glycol. (2) Coatings cured by polymerization, Ethylene glycol. condensation, and/or cross-linking Pentaerythritol. without oxidation. Polyethylene glycol. (3) Coatings prepared from prepoly- Polypropylene glycol. merized substances. Propylene glycol. (b) The coatings are formulated from Sorbitol. optional substances that may include: Trimethylol ethane. (1) Substances generally recognized Trimethylol propane. as safe in food. (iii) Synthetic drying oils, as the (2) Substances the use of which is basic polymer: permitted by regulations in this part or which are permitted by prior sanc- Butadiene and methylstyrene copolymer. tion or approval and employed under Butadiene and styrene copolymer, blown or the specific conditions, if any, of the unblown. Maleic anhydride adduct of butadiene sty- prior sanction or approval. rene. (3) Any substance employed in the Polybutadiene. production of resinous and polymeric coatings that is the subject of a regula- (iv) Natural fossil resins, as the basic tion in subchapter B of this chapter resin: and conforms with any specification in Copal. such regulation. Substances named in Damar. this paragraph (b)(3) and further identi- Elemi. fied as required: Gilsonite. (i) Drying oils, including the Glycerol ester of damar, copal, elemi, and triglycerides or fatty acids derived sandarac. therefrom: Sandarac. Shellac. Beechnut. Utah coal resin. Candlenut. Castor (including dehydrated). (v) Rosins and rosin derivatives, with Chinawood (tung). or without modification by polymeriza- Coconut. tion, isomerization, incidental Corn. decarboxylation, and/or hydrogenation, Cottonseed. as follows: Fish (refined). (a) Rosins, refined to color grade of K Hempseed. or paler: Linseed. Oiticica. Gum rosin. Perilla. Tall oil rosin. Poppyseed. Wood rosin. Pumpkinseed. (b) Rosin esters formed by reacting Safflower. Sesame. rosin (paragraph (b)(3)(v)(a) of this sec- Soybean. tion) with: Sunflower. 4,4′-sec-Butylidenediphenol-epichlorohydrin Tall oil. (epoxy). Walnut. Diethylene glycol. Ethylene glycol. The oils may be raw, heat-bodied, or Glycerol. blown. They may be refined by filtra- 4,4′-Isopropylidenediphenol-epichlorohydrin tion, degumming, acid or alkali wash- (epoxy). ing, bleaching, distillation, partial de- Methyl alcohol. hydration, partial polymerization, or Pentaerythritol.

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(c) Rosin esters (paragraph (b)(3)(v)(b) 4,4-Bis(4′-hydroxyphenyl)-pentanoic acid. of this section) modified by reaction tert-Butyl benzoic acid. with: Fatty acids derived from oils listed in paragraph (b)(3)(i) of this section. Maleic anhydride. Rosins listed in paragraph (b)(3)(v)(a) of this o-, m-, and p-substituted phenol-formalde- section, for use only as reactants in oil- hydes listed in paragraph (b)(3)(vi) of this based or fatty acid-based alkyd resins. section. (c) Polyhydric alcohols: Phenol-formaldehyde. (d) Rosin salts: Butylene glycol. Diethylene glycol. Calcium resinate (limed rosin). 2,2-Dimethyl-1,3-propanediol for use only in Zinc resinate. forming polyester resins for coatings intended for use in contact with non-alco- (vi) Phenolic resins as the basic poly- holic foods. mer formed by reaction of phenols with Ethylene glycol. formaldehyde: Glycerol. (a) Phenolic resins formed by reac- Mannitol. tion of formaldehyde with: a-Methyl glucoside. Pentaerythritol. Alkylated (methyl, ethyl, propyl, isopropyl, Propylene glycol. butyl) phenols. Sorbitol. p-tert-Amylphenol. Triethylene glycol, for use as a component in 4,4′-sec-Butylidenediphenol. polyester resins for coatings not exceeding p-tert-Butylphenol. a coating weight of 4 milligrams per square o-, m-, and p-Cresol. inch and that are intended for contact p-Cyclohexylphenol. under conditions of use D, E, F or G de- 4,4′-Isopropylidenediphenol. scribed in table 2 of paragraph (d) of this p-Nonylphenol. section with alcoholic beverages con- p-Octylphenol. taining less than 8 percent alcohol. 3-Pentadecyl phenol mixture obtained from Trimethylol ethane. cashew nut shell liquid. Trimethylol propane. Phenol. (d) Monohydric alcohols: Phenyl o-cresol. p-Phenylphenol. Cetyl alcohol. Xylenol. Decyl alcohol. Lauryl alcohol. (b) Adjunct for phenolic resins: Alu- Myristyl alcohol. minum butylate. Octyl alcohol. (vii) Polyester resins (including Stearyl alcohol. alkyd-type), as the basic polymers, (e) Catalysts: formed as esters of acids listed in paragraph (b)(3)(vii) (a) and (b) of this sec- Dibutyltin oxide (CAS Reg. No. 818–08–6), not tion by reaction with alcohols in para- to exceed 0.2 percent of the polyester resin. graph (b)(3)(vii) (c) and (d) of this sec- Hydroxybutyltin oxide (CAS Reg. No. 2273– tion. 43–0), not to exceed 0.2 percent of the polyester resin. (a) Polybasic acids: Monobutyltin tris(2-ethylhexoate) (CAS Reg. Adipic. No. 23850–94–4), not to exceed 0.2 percent of 1,4-cyclohexanedicarboxylic (CAS Reg. No. the polyester resin. 1076–97–7). (viii) Epoxy resins, catalysts, and ad- Dimerized fatty acids derived from oils listed juncts: in paragraph (b)(3)(i) of this section. Fumaric. (a) Epoxy resins, as the basic poly- Isophthalic. mer: Maleic. (Alkoxy C10-C16)-2,3-epoxypropane, in which 2,6-Naphthalenedicarboxylic. the alkyl groups are even numbered and 2,6-Naphthalenedicarboxylic, dimethyl ester. consist of a maximum of 1 percent C10 car- Orthophthalic. bon atoms and a minimum of 48 percent C12 Sebacic. carbon atoms and a minimum of 18 percent Terephthalic. C14 carbon atoms, for use only in coatings Terpene-maleic acid adduct. that are intended for contact with dry bulk Trimellitic. foods at room temperature. (b) Monobasic acids: 4,4′-sec-Butylidenediphenol-epichlorohydrin. 4,4′-sec-Butylidenediphenol-epichlorohydrin Benzoic acid. reacted with one or more of the drying oils

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or fatty acids listed in paragraph (b)(3)(i) Benzyl alcohol (CAS Reg. No. 100–51–6), for of this section. use only in coatings at a level not to ex- 4,4′-sec-Butylidenediphenol-epichlorohydrin ceed 4 percent by weight of the resin when chemically treated with one or more of such coatings are intended for repeated use the following substances: in contact with foods only of the types Allyl ether of mono-, di-, or trimethylol identified in paragraph (d) of this section, phenol. table 1, under Types I, II, and III, under 4,4′-sec-Butylidenediphenol-formaldehyde. conditions of use C, D, E, or F as described 4,4′-Isopropylidenediphenol-formaldehyde. in table 2 of paragraph (d) of this section; Melamine-formaldehyde. or when such coatings are intended for re- Phenol-formaldehyde. peated use in contact with foods of the Urea-formaldehyde. types identified in paragraph (d) of this Epoxidized polybutadiene. section, table 1, under Types V, VI, VII, Glycidyl ethers formed by reacting and VIII, under conditions of use E or F as phenolnovolak resins with described in table 2 of paragraph (d) of this epichlorohydrin. section. Use shall be limited to coatings 4,4′-Isopropylidenediphenol-epichlorohydrin. for tanks of capacity greater than 530,000 4,4′-Isopropylidenediphenol-epichlorohydrin gallons. reacted with one or more of the drying oils Catalysts and cross-linking agents for epoxy or fatty acids listed in paragraph (b)(3)(i) resins: of this section. 3-Aminomethyl-3,5,5- 4,4′-Isopropylidenediphenol-epichlorohydrin trimethylcyclohexylamine (CAS Reg. No. chemically treated with one or more of 2855–0913–092). the following substances: Cyanoguanidine. Allyl ether of mono-, di-, or trimethylol Dibutyl phthalate, for use only in coatings phenol. for containers having a capacity of 1,000 4,4′-sec-Butylidenediphenol-formaldehyde. gallons or more when such containers are 4,4′-Isopropylidenediphenol-formaldehyde. intended for repeated use in contact with Melamine-formaldehyde. alcoholic beverages containing up to 8 per- 2,2′-[(1-methylethylidene)bis[4,1- cent of alcohol by volume. phenyleneoxy[1-(butoxymethyl)-2,1- 3-Diethylaminopropylamine (CAS Reg. No. ethanediyl]oxymethylene]]bisoxirane, 104–78–9), for use in coatings at a level not CAS Reg. No. 71033–08–4, for use only in to exceed 6 percent by weight of the resin coatings intended for contact with bulk when such coatings are intended for redry foods at temperatures below 100 °F. peated use in contact with foods only of Phenol-formaldehyde. the types identified in paragraph (d) of this Urea-formaldehyde. section, table 1, under Types I, II, and III, (b) Catalysts and cross-linking agents under conditions of use C, D, E, or F as de- for epoxy resins: scribed in table 2 of paragraph (d) of this section; or when such coatings are in- 3-(Aminomethyl)-3,5,5-trimethylcyclohexyl- tended for repeated use in contact with amine reacted with phenol and formalde- foods of the types identified in paragraph hyde in a ratio of 2.6:1.0:2.0, for use only in (d) of this section, table 1, under Types V, coatings intended for repeated use in con- VI, VII, and VIII, under conditions of use E tact with foods only of the types identified or F as described in table 2 of paragraph (d) in paragraph (d) of this section, table 1, of this section. Use shall be limited to under Category I and Category VIII, at coatings for tanks of capacity greater than temperatures not exceeding 88 °C (190 °F). 530,000 gallons. N-Beta-(aminoethyl)-gamma-aminopropyltri- Diethylenetriamine. methoxysilane (CAS Reg. No. 1760–24–3), for Diphenylamine. use only in coatings at a level not to ex- Ethylenediamine. ceed 1.3 percent by weight of the resin Isophthalyl dihydrazide for use only in coat- when such coatings are intended for re- ings subject to the provisions of paragraph peated use in contact with foods only of (c) (3) or (4) of this section. the types identified in paragraph (d) of this 4,4′-Methylenedianiline, for use only in coat- section, table 1, under Types I, II, and III, ings for containers having a capacity of under conditions of use C, D, E, or F as de- 1,000 gallons or more when such containers scribed in table 2 of paragraph (d) of this are intended for repeated use in contact section; or when such coatings are in- with alcoholic beverages containing up to 8 tended for repeated use in contact with percent of alcohol by volume. foods of the types identified in paragraph N-Oleyl-1,3-propanediamine with not more (d) of this section, table 1, under Types V, than 10 percent by weight of VI, VII, and VIII, under conditions of use E diethylaminoethanol. or F as described in table 2 of paragraph (d) 3-Pentadecenyl phenol mixture (obtained of this section. Use shall be limited to from cashew nutshell liquid) reacted with coatings for tanks of capacity greater than formaldehyde and ethylenediamine in a 530,000 gallons. ratio of 1:2:2 (CAS Reg. No. 68413–28–5).

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Polyamine produced when 1 mole of the and G described in table 2 of paragraph (d) chlorohydrin diether of polyethylene gly- of this section. col 400 is made to react under Trimellitic anhydride adducts of ethylene dehydrohalogenating conditions with 2 glycol and glycerol, prepared by the reac- moles of N-octadecyltrimethylenediamine tion of 1 mole of trimellitic anhydride with for use only in coatings that are subject to 0.4–0.6 mole of ethylene glycol and 0.04–0.12 the provisions of paragraph (c) (3) or (4) of mole of glycerol, for use only as a cross- this section and that contact food at tem- linking agent at a level not to exceed 10 peratures not to exceed room temperature. percent by weight of the cured coating, Polyethylenepolyamine (CAS Reg. No. 68131– provided that the cured coating only con- 73–7), for use only in coatings intended for tacts food containing not more than 8 per- repeated use in contact with food, at tem- cent alcohol. peratures not to exceed 180 °F (82 °C). Meta-Xylylenediamine (1,3-benzenedi- Salicylic acid, for use only in coatings for methanamine, CAS Reg. No. 1477–55–0), for containers having a capacity of 1,000 gal- use only in coatings at a level not to ex- lons or more when such containers are in- ceed 3 percent by weight of the resin when tended for repeated use in contact with al- such coatings are intended for repeated use coholic beverages containing up to 8 per- in contact with foods only of the types cent of alcohol by volume. identified in paragraph (d) of this section, Salicylic acid (CAS Reg. No. 69–72–7), for use table 1, under Types I, II, and III, under only in coatings at a level not to exceed conditions of use C, D, E or F as described 0.35 percent by weight of the resin when in table 2 of paragraph (d) of this section; such coatings are intended for repeated use or when such coatings are intended for re- in contact with foods only of the types peated use in contact with foods of the identified in paragraph (d) of this section, types identified in paragraph (d) of this table 1, under Types I, II, and III, under section, table 1, under Types V, VI, VII, conditions of use C, D, E, or F as described and VIII, under conditions of use E or F as in table 2 of paragraph (d) of this section; described in table 2 of paragraph (d) of this or when such coatings are intended for re- section. Use shall be limited to coatings peated use in contact with foods of the for tanks of capacity greater than 530,000 types identified in paragraph (d) of this gallons. section, table 1, under Types V, VI, VII, Para-Xylylenediamine (1,4 benzenedimethan- and VIII, under conditions of use E or F as amine, CAS Reg. No. 539–48–0), for use only described in table 2 of paragraph (d) of this in coatings at a level not to exceed 0.6 per- section. Use shall be limited to coatings cent by weight of the resin when such coat- for tanks of capacity greater than 530,000 ings are intended for repeated use in con- gallons. tact with foods only of the types identified Stannous 2-ethylhexanoate for use only as a in paragraph (d) of this section, table 1, catalyst at a level not to exceed 1 percent under Types I, II, III, under conditions of by weight of the resin used in coatings that use C, D, E, or F as described in table 2 of are intended for contact with food under paragraph (d) of this section; or when such conditions of use D, E, F, and G described coatings are intended for repeated use in in table 2 of paragraph (d) of this section. contact with foods of the types identified Styrene oxide, for use only in coatings for in paragraph (d) of this section, table 1, containers having a capacity of 1,000 gal- under Types V, VI, VII, and VIII, under lons or more when such containers are in- conditions of use E and F as described in tended for repeated use in contact with al- table 2 of paragraph (d) of this section. Use coholic beverages containing up to 8 per- shall be limited to coatings for tanks of ca- cent of alcohol by volume. pacity greater than 530,000 gallons. Tetraethylenepentamine. (c) Adjuncts for epoxy resins: Tetraethylenepentamine reacted with equimolar quantities of fatty acids. Aluminum butylate. Tri(dimethylaminomethyl) phenol and its Benzoic acid, for use as a component in salts prepared from the fatty acid moieties epoxy resins for coatings not exceeding a of the salts listed in paragraph coating weight of 4 milligrams per square (b)(3)(xxii)(b) of this section, for use only inch and that are intended for contact in coatings subject to the provisions of under conditions of use D, E, F or G de- paragraph (c) (3) or (4) of this section. scribed in table 2 of paragraph (d) of this Triethylenetetramine. section with alcoholic beverages con- Trimellitic anhydride (CAS Reg. No. 552–30– taining less than 8 percent alcohol. 7) for use only as a cross-linking agent at Polyamides from dimerized vegetable oils a level not to exceed 15 percent by weight and the amine catalysts listed in para- of the resin in contact with food under all graph (b)(3)(viii)(b) of this section, as the conditions of use, except that resins in- basic polymer. tended for use with foods containing more Silane coupled silica, prepared from the re- than 8 percent alcohol must contact such action of microcrystalline quartz with N- food only under conditions of use D, E, F, beta-(N-vinylbenzylamino) ethyl-gamma-

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aminopropyltrimethoxy silane, mono- Triethanolamine. hydrogen chloride, for use only in coatings Melamine-formaldehyde chemically modified intended for repeated use in contact with with methyl, ethyl, propyl, isopropyl, foods only of the types identified in para- butyl, or isobutyl alcohol. graph (d) of this section, table 1, under Category I and Category VIII, at tempera- (b) Curing (cross-linking) catalyst for tures not exceeding 88 °C (190 °F). triazine-formaldehyde resins: Succinic anhydride, for use as a component Dodecyl benzenesulfonic acid (C.A. Registry in epoxy resins for coatings not exceeding No. 27176–87–0). a coating weight of 4 milligrams per square inch, and that are intended for contact (xiv) Modifiers (for oils and alkyds, under conditions of use D, E, F or G de- including polyesters), as the basic poly- scribed in table 2 of paragraph (d) of this mer: section with alcoholic beverages containing less than 8 percent alcohol. Butyl methacrylate. Cyclopentadiene. (ix) Coumarone-indene resin, as the Methyl, ethyl, butyl, or octyl esters of acryl- basic polymer. ic acid. (x) Petroleum hydrocarbon resin Methyl methacrylate. (cyclopentadiene type), as the basic Styrene. Vinyl toluene. polymer. (xi) Terpene resins, as the basic poly- (xv) Vinyl resinous substance, as the mer, from one or more of the following: basic polymers: Dipentene. Polyvinyl acetate. Hydrogenated dipentene resin (CAS Reg. No. Polyvinyl alcohol. 106168–39–2). For use only with coatings in Polyvinyl butyral. contact with acidic and aqueous foods. Polyvinyl chloride. Hydrogenated-beta-pinene-alpha-pinene- Polyvinyl formal. dipentene copolymer resin (CAS Reg. No. Polyvinylidene chloride. 106168–37–0). For use only with coatings in Polyvinyl pyrrolidone. contact with acidic and aqueous foods. Polyvinyl stearate. a-Pinene. Vinyl chloride-acetate-2,3-epoxypropyl meth- b-Pinene. acrylate copolymers containing not more than 10 weight percent of total polymer (xii) Urea-formaldehyde, resins and units derived from 2,3-epoxypropyl meth- their curing catalyst: acrylate and not more than 0.1 weight per- (a) Urea-formaldehyde resins, as the cent of unreacted 2,3-epoxypropyl meth- basic polymer: acrylate monomer for use in coatings for containers. Urea-formaldehyde. Vinyl chloride-acetate, hydroxyl-modified Urea-formaldehyde chemically modified with copolymer. methyl, ethyl, propyl, isopropyl, butyl, or Vinyl chloride-acetate, hydroxyl-modified isobutyl alcohol. copolymer, reacted with trimellitic anhy- Urea-formaldehyde chemically modified with dride. one or more of the amine catalysts listed Vinyl chloride copolymerized with acryl- in paragraph (b)(3)(viii)(b) of this section. amide and ethylene in such a manner that the finished copolymers have a minimum (b) Curing (cross-linking) catalyst for weight average molecular weight of 30,000 urea-formaldehyde resins: and contain not more than 3.5 weight per- Dodecyl benzenesulfonic acid (C.A. Registry cent of total polymer units derived from No. 27176–87–0). acrylamide; the acrylamide portion may or may not be subsequently partially (xiii) Triazine-formaldehyde resins hydrolyzed. and their curing catalyst: Vinyl chloride copolymerized with one or (a) Triazine-formaldehyde resins, as more of the following substances: the basic polymer: Acrylonitrile. Fumaric acid and/or its methyl, ethyl, Benzoguanamine-formaldehyde. propyl, butyl, amyl, hexyl, heptyl, or octyl Melamine-formaldehyde. esters. Melamine-formaldehyde chemically modified Maleic acid and/or its methyl, ethyl, propyl, with one or more of the following amine butyl, amyl, hexyl, heptyl, or octyl esters. catalysts: 5-Norbornene-2,3-dicarboxylic acid, mono-n- Amine catalysts listed in paragraph butyl ester; for use such that the finished (b)(3)(viii)(b) of this section. vinyl chloride copolymers contain not Dimethylamine-2-methyl-1-propanol. more than 4 weight percent of total poly- Methylpropanolamine. mer units derived from this comonomer.

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Vinyl acetate. (HFS–200), Food and Drug Administration, Vinylidene chloride. 5100 Paint Branch Pkwy., College Park, Vinyl chloride-vinylidene chloride-2,3- MD 20740, or available for inspection at the epoxypropyl methacrylate copolymers con- Office of the Federal Register, 800 North taining not more than 10 weight percent of Capitol Street, NW., suite 700, Washington, total polymer units derived from 2,3- DC 20408. epoxypropyl methacrylate and not more than 0.05 weight percent of unreacted 2,3- (xx) Acrylics and their copolymers, epoxypropyl methacrylate monomer based as the basic polymer: on polymer solids for use only in coatings Acrylamide with ethylacrylate and/or sty- for containers intended for contact with rene and/or methacrylic acid, subsequently foods under conditions B, C, D, E, F, G, or reacted with formaldehyde and butanol. H described in table 2 of paragraph (d) of Acrylic acid and the following esters thereof: this section. Ethyl. (xvi) Cellulosics, as the basic poly- Methyl. mer: Butyl acrylate-styrene-methacrylic acid-hydroxyethyl methacrylate copolymers con- Carboxymethylcellulose. taining no more than 20 weight percent of Cellulose acetate. total polymer units derived from meth- Cellulose acetate-butyrate. acrylic acid and containing no more than 7 Cellulose acetate-propionate. weight percent of total polymer units de- Ethylcellulose. rived from hydroxyethyl methacrylate; for Ethyl hydroxyethylcellulose. use only in coatings that are applied by Hydroxyethylcellulose. electrodeposition to metal substrates. Hydroxypropyl methylcellulose. Butyl acrylate-styrene-methacrylic acid- Methylcellulose. hydroxypropyl methacrylate copolymers Nitrocellulose. containing no more than 20 weight percent (xvii) Styrene polymers, as the basic of total polymer units derived from methacrylic acid and containing no more than 7 polymer: weight percent of total polymer units de- Polystyrene. rived from hydroxypropyl methacrylate; a-Methyl styrene polymer. for use only in coatings that are applied by Styrene copolymerized with one or more of electrodeposition to metal substrates and the following: that are intended for contact, under condi- Acrylonitrile. tion of use D, E, F, or G described in table a-Methylstyrene. 2 of paragraph (d) of this section, with food containing no more than 8 percent of alco- (xviii) Polyethylene and its copoly- hol. mers as the basic polymer: Ethyl acrylate-styrene-methacrylic acid copolymers for use only as modifiers for Ethylene-ethyl acrylate copolymer. epoxy resins listed in paragraph Ethylene-isobutyl acrylate copolymers con- (b)(3)(viii)(a) of this section. taining no more than 35 weight percent of Ethyl acrylate-methyl methacrylate-sty- total polymer units derived from isobutyl rene-methacrylic acid copolymers for use acrylate. only as modifiers for epoxy resins listed in Ethylene-vinyl acetate copolymer. paragraph (b)(3)(viii)(a) of this section. Polyethylene. 2-Ethylhexyl acrylate-ethyl acrylate copoly- (xix) Polypropylene as the basic polymers prepared by copolymerization of 2- mer: ethylhexyl acrylate and ethyl acrylate in a 7/3 weight ratio and having a number aver- Polypropylene. age molecular weight range of 5,800 to 6,500 Maleic anhydride adduct of polypropylene and a refractive index, nD25° (40 percent in The polypropylene used in the manufac- 2,2,4-trimethyl pentane) of 1.4130–1.4190; for ture of the adduct complies with use as a modifier for nylon resins com- § 177.1520(c), item 1.1; and the adduct has a plying with § 177.1500 of this chapter and for maximum combined maleic anhydride con- phenolic and epoxy resins listed in para- tent of 0.8 percent and a minimum intrin- graph (b)(3) (vi) and (viii) of this section, sic viscosity of 0.9, determined at 135 °C on respectively, at a level not to exceed 1.5 a 0.1 percent solution of the modified poly- percent of the coating. propylene in decahydronaphthalene as de- 2-Ethylhexyl acrylate-methyl methacrylate- termined by a method titled ‘‘Method for acrylic acid copolymers for use only as Determination of Intrinsic Viscosity of modifiers for epoxy resins listed in para- Maleic Anhydride Adduct of Poly- graph (b)(3)(viii) of this section. propylene,’’ which is incorporated by ref- Methacrylic acid and the following esters erence. Copies are available from the Cen- thereof: ter for Food Safety and Applied Nutrition Butyl.

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Ethyl. Aluminum. Methyl. Calcium. Methacrylic acid or its ethyl and methyl Cerium. esters copolymerized with one or more of Cobalt. the following: Iron. Acrylic acid. Lithium. Ethyl acrylate. Magnesium. Methyl acrylate. Manganese. n-Butyl acrylate-styrene-methacrylic acid- Zinc. hydroxyethyl methacrylate copolymers Zirconium. containing no more than 2 weight percent (b) Salts: of total polymer units derived from methacrylic acid and containing no more than Caprate. 9.5 weight percent of total polymer units Caprylate. derived from hydroxyethyl methacrylate; Isodecanoate. for use only in coatings in contact with dry Linoleate. food (food type VIII in table 1 of paragraph Naphthenate. (d) of this section). 2-(Dimethylamino) eth- Neodecanoate. anol (C.A.S. Registry No. 108–01–0) may be Octoate (2-ethylhexoate). employed as an optional adjuvant sub- Oleate. stance limited to no more than 2 weight Palmitate. percent based on polymer solids in the Resinate. coating emulsion. Ricinoleate. Styrene polymers made by the polymeriza- Soyate. tion of any combination of styrene or Stearate. alpha methyl styrene with acrylic acid, Tallate. methacrylic acid, 2-ethyl hexyl acrylate, methyl methacrylate, and butyl acrylate. (xxiii) Waxes: The styrene and alpha methyl styrene, in- Paraffin, Type I. dividually, may constitute from 0 to 80 Paraffin, Type II. weight percent of the polymer. The other Polyethylene. monomers, individually, may be from 0 to Sperm oil. 40 weight percent of the polymer. The poly- Spermaceti. mer number average molecular weight (Mn) shall be at least 2,000 (as determined by gel (xxiv) Plasticizers: permeation chromatography). The acid Acetyl tributyl citrate. number of the polymer shall be less than Acetyl triethyl citrate. 250. The monomer content shall be less Butyl phthalyl butyl glycolate. than 0.5 percent. The polymers are for use Butyl stearate. only in contact with food of Types IV–A, V, p-tert-Butyl phenyl salicylate. VII in table 1 of paragraph (d) of this sec- Dibutyl sebacate. tion, under use conditions E through G in Diethyl phthalate. table 2 of paragraph (d), and with food of Diisobutyl adipate. Type VIII without use temperature restric- Diisooctyl phthalate. tion. Epoxidized soybean oil (iodine number max- (xxi) Elastomers, as the basic poly- imum 14; oxirane oxygen content 6% min- mer: imum), as the basic polymer. Ethyl phthalyl ethyl glycolate. Butadiene-acrylonitrile copolymer. 2-Ethylhexyl diphenyl phosphate. Butadiene-acrylonitrile-styrene copolymer. di-2-Ethylhexyl phthalate. Butadiene-styrene copolymer. Glycerol. Butyl rubber. Glyceryl monooleate. Chlorinated rubber. Glyceryl triacetate. 2-Chloro-1,3-butadiene (neoprene). Monoisopropyl citrate. Natural rubber (natural latex or natural Propylene glycol. latex solids, smoked or unsmoked). Sorbitol. Polyisobutylene. Mono-, di-, and tristearyl citrate. Rubber hydrochloride. Triethyl citrate. Styrene-isobutylene copolymer. Triethylene glycol. 3-(2-Xenolyl)-1,2-epoxypropane. (xxii) Driers made by reaction of a metal from paragraph (b)(3)(xxii)(a) of (xxv) Release agents, as the basic this section with acid, to form the salt polymer, when applicable: listed in paragraph (b)(3)(xxii)(b) of this N,N′-Dioleoylethylenediamine (CAS Reg. No. section: 110–31–6) for use only in ionomeric resins (a) Metals: complying with § 177.1330 of this chapter

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and in ethylene vinyl acetate copolymers 3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. complying with § 177.1350 of this chapter at 107–54–0), at a level not to exceed 0.53 a level not to exceed 0.0085 milligram per weight-percent; square centimeter (0.055 milligram per 1-Ethynylcyclohexene (CAS Reg. No. 931–49– square inch) in the finished food-contact 7), at a level not to exceed 0.64 weight-per- article. cent; N,N′-Distearoyl ethylenediamine. Bis(methoxymethyl)ethyl maleate (CAS Reg. Linoleic acid amide. No. 102054–10–4), at a level not to exceed 1.0 Oleic acid amide. weight-percent; Palmitic acid amide. Methylvinyl cyclosiloxane (CAS Reg. No. Petrolatum. 68082–23–5); and Tetramethyltetravinylcyclotetrasiloxane Polyethylene wax. (CAS Reg. No. 2554–06–5). Polyoxyethylene glycol monooleate (mol. wt. of the polyoxyethylene glycol moiety (b) Curing (cross-linking) catalysts greater than 300). for silicones (the maximum amount of Polytetrafluoroethylene. tin catalyst used shall be that required Silicones (not less than 300 centistokes vis- to effect optimum cure but shall not cosity): Dimethylpolysiloxanes and/or exceed 1 part of tin per 100 parts of si- methylphenylpolysiloxanes. The methylphenylpolysiloxanes contain not more than loxane resins solids): 2.0 percent by weight of cyclosiloxanes Dibutyltin dilaurate. having up to and including 4 siloxy units. Stannous oleate. Silicones (not less than 100 centistokes vis- Tetrabutyl titanate. cosity): Dimethylpolysiloxanes and/or methylphenylpolysiloxanes limited to use (xxix) Surface active agents: only on metal substrates. The Ethylene oxide adduct of 2,4,7,9-tetramethyl- methylphenylpolysiloxanes contain not 5-decyn-4,7-diol (CAS Reg. No. 9014–85–1). more than 2.0 percent by weight of Poly[2-(diethylamino) ethyl methacrylate] cyclosiloxanes having up to and including 4 phosphate (minimum intrinsic viscosity in siloxy units. water at 25 °C is not less than 9.0 deciliters (xxvi) Colorants used in accordance per gram as determined by ASTM method D1243–79, ‘‘Standard Test Method for Dilute with § 178.3297 of this chapter. Solution Viscosity of Vinyl Chloride Poly- (xxvii) Surface lubricants: mers,’’ which is incorporated by reference Cottonseed oil and other edible oils. (copies may be obtained from the Amer- ican Society for Testing Materials, 1916 Dibutyl sebacate. Race St., Philadelphia, PA 19103, or may be Dioctyl sebacate. examined at the Office of the Federal Reg- Glyceryl monostearate. ister, 800 North Capitol Street, NW., suite Lanolin. 700, Washington, DC 20408), for use only as Mineral oil, white. a suspending agent in the manufacture of Palm oil. vinyl chloride copolymers and limited to Paraffin, Type I. use at levels not to exceed 0.1 percent by Paraffin, Type II. weight of the copolymers. Petrolatum. Sodium dioctyl sulfosuccinate. Stearic acid. Sodium dodecylbenzenesulfonate Sodium lauryl sulfate. (xxviii) Silicones and their curing 2,4,7,9-Tetramethyl-5-decyn-4,7-diol (C.A.S. catalysts: Reg. No. 126-86-3), for use only in can coat- (a) Silicones as the basic polymer: ings which are subsequently dried and cured at temperatures of at least 193 °C (380 Siloxane resins originating from methyl hy- °F) for 4 minutes. drogen polysiloxane, dimethyl polysiloxane, and methylphenyl (xxx) Antioxidants: polysiloxane. Butylated hydroxyanisole. Siloxane resins originating from the plat- Butylated hydroxytoluene. inum-catalyzed reaction product of vinyl- Gum guaiac. containing dimethylpolysiloxane (CAS Dilauryl thiodipropionate. Reg. No. 68083–18–1 and CAS Reg. No. 68083– Nordihydroguaiaretic acid. 19–2) with methylhydrogen polysiloxane Propyl gallate. (CAS Reg. No. 63148–57–2) and Distearyl thiodipropionate. dimethylmethylhydrogen polysiloxane Thiodipropionic acid. (CAS Reg. No. 68037–59–2), where the plat- 2,4,5-Trihydroxybutyrophenone. inum content does not exceed 150 parts per million. The following substances may be (xxxi) Can end cements (sealing com- used as optional polymerization inhibitors: pounds used for sealing can ends only):

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In addition to the substances listed in 4,4′-Bis(alpha,alpha-dimethyl- paragraph (b) of this section and those benzyl)diphenylamine, CAS Reg. No. 10081– listed in § 177.1210(b)(5) of this chapter, 67–1. the following may be used: Ethyl toluene sulfonamide. N,N′-Hexamethylenebis(3,5-di-tert-butyl-4- Butadiene-styrene-divinylbenzene copolymer hydroxyhydrocinnamide), CAS Reg. No. (CAS Reg. No. 26471–45–4) for use only at 23128–74–7. levels not to exceed 23.8 percent by weight Polyamides consisting of the following: of the cement solids in can end cements. Copolymer of omega-laurolactam and Butadiene-styrene-fumaric acid copolymer. espilon-caprolactam, CAS Reg. No. 25191– 4,4′-Butylidenebis (6-tert-butyl-m-cresol). 04–2 (Nylon 12/6). Dibenzamido phenyl disulfide. Homopolymer of omega-aminododecanoic Di-b-naphthyl phenylenediamine. acid, CAS Reg. No. 24937–16–4. Dipentamethylene thiuram tetrasulfide. Homopolymer of omega-laurolactam, CAS Isobutylene-isoprene-divinylbenzene copoly- Reg. No. 25038–74–8 (Nylon 12). mers for use only at levels not to exceed 15 Polyamides derived from the following acids percent by weight of the dry cement com- and amines: position. Acids: Naphthalene sulfonic acid-formaldehyde con- Adipic. densate, sodium salt, for use only at levels Azelaic. not to exceed 0.6 percent by weight of the Sebacic. cement solids in can end cements for con- Vegetable oil acids (with or without tainers having a capacity of not less than dimerization). 5 gallons. Sodium decylbenzene sulfonate. Amines: Sodium nitrite for use only at levels not to Diethylenetriamine. exceed 0.3 percent by weight of the cement Diphenylamine. solids in can end cements for containers Ethylenediamine. having a capacity of not less than 5 gal- Hexamethylenediamine. lons. Tetraethylenepentamine. Sodium pentachlorophenate for use as a pre- Triethylenetetramine. servative at 0.1 percent by weight in can- Polypropylene glycol CAS Reg. No. 25322–69– sealing compounds on containers having a 4. capacity of 5 gallons or more. Sodium pentachlorophenate for use as a pre- Sodium phenylphenate. servative at 0.1 percent by weight in can- Styrene-maleic anhydride resin, partial sealing compounds on containers having a methyl and butyl (sec- or iso-) esters, for capacity of 5 gallons or more. use only at levels not in excess of 3 percent Tetrakis [methylene(3,5-di-tert-butyl-4- of the cement solids in can end cement for- hydroxyhydrocinnamate)]methane, CAS mulations. Reg. No. 6683–19–8. Tetrasodium EDTA (tetrasodium ethylene- Toluene sulfonamide formaldehyde resin diaminetetraacetate). (basic polymer). Tri (mixed mono- and dinonylphenyl) Triethylene glycol methacrylate for use only phosphite. as polymerization cross-linking agent in Zinc dibutyldithiocarbamate. side seam cements for containers intended (xxxii) Side seam cements: In addi- for use in contact with food only of the types identified in paragraph (d) of this tion to the substances listed in para- section, table 1, under Categories I, II, and graph (b)(3) (i) to (xxx), inclusive, of VI. this section, the following may be used. Urea. p-tert-Butyl perbenzoate as a catalyst for (xxxiii) Miscellaneous materials: epoxy resin. epsilon-Caprolactam-(ethylene-ethyl acry- Ammonium citrate. late) graft polymer. Ammonium potassium phosphate. Dicumyl peroxide for use only as polymeriza- Bentonite, modified by reaction with benzyl tion catalyst. dimethyl alkyl ammonium chloride, where 4–(Diiodomethylsulfonyl) toluene (CAS Reg. the alkyl groups are derived from hydro- No. 20018–09–1) for use as a preservative at genated tallow (CAS Reg. No. 71011–24–0). a level not to exceed 0.3 percent by weight For use only as a rheological agent in coat- in can–sealing cements. ings intended to contact food under re- Diisodecyl phthalate for use only as plasti- peated use conditions. cizer in side seam cements for containers Bentonite, modified by reaction with sodium intended for use in contact with food only stearate and benzyl dimethyl alkyl ammo- of the types identified in paragraph (d) of nium chloride, where the alkyl groups are this section, table 1, under Categories I, II, derived from hydrogenated tallow (CAS and VI. Reg. No. 121888–68–4). For use as a

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rheological agent only in coatings in- amined at the Office of the Federal Reg- tended to contact dry food under repeated- ister, 800 North Capitol Street, NW., suite use conditions. 700, Washington, DC 20408. For use only in Calcium acetate. contact with nonalcoholic and nonfatty Calcium ethyl acetoacetate. foods under conditions of use E, F, and G, Calcium glycerophosphate. described in table 2 of paragraph (d) this Calcium, sodium, and potassium oleates. section. Calcium, sodium, and potassium Decyl alcohol. ricinoleates. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg No. Calcium, sodium, and potassium stearates. 35691–65–7). For use as an antimicrobial Castor oil, hydrogenated. agent at levels not to exceed 500 milli- Castor oil, hydrogenated polymer with ethyl- grams per kilogram in emulsion-based sili- enediamine, 12-hydroxyoctadecanoic acid cone coatings. and sebacic acid (CAS Reg. No. 68604–06–8). Disodium hydrogen phosphate. The condensation product formed by the Ethyl acetoacetate. reaction of hydrogenated castor oil with Hectorite, modified by reaction with a mix- polyamide derived from ethylenediamine, ture of benzyl methyl dialkyl ammonium sebacic acid and 12-hydroxystearic acid, for chloride and dimethyl dialkyl ammonium use only in coatings at a level not to ex- chloride, where the alkyl groups are de- ceed 3.2 percent by weight of the resin rived from hydrogenated tallow (CAS Reg. when such coatings are intended for re- No. 121888–67–3). For use as a rheological peated use in contact with foods only of agent only in coatings intended to contact the types identified in paragraph (d) of this dry food under repeated-use conditions. section, table 1, under Types I, II, and III, Lauryl alcohol. under conditions of use C, D, E, or F as de- Lecithin. scribed in table 2 of paragraph (d) of this Magnesium, sodium, and potassium citrate. section; or when such coatings are in- Magnesium glycerophosphate. tended for repeated use in contact with Magnesium stearate. foods of the types identified in paragraph Mono-, di-, and tricalcium phosphate. (d) of this section, table 1, under Types V, Monodibutylamine pyrophosphate as VI, VII, and VIII, under conditions of use E sequestrant for iron. or F as described in table 2 of paragraph (d) Mono-, di-, and trimagnesium phosphate. of this section. Use shall be limited to Myristyl alcohol. coatings for tanks of capacity greater than Octyl alcohol. 530,000 gallons. Phosphoric acid. Castor oil, sulfated, sodium salt (CAS Reg. Polybutene, hydrogenated; complying with No. 68187–76–8), for use only in coatings for the identity and limitations prescribed by containers intended for repeated use. § 178.3740 of this chapter. Cetyl alcohol. Poly(ethylene oxide). 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Siloxanes and silicones, dimethyl, 3- Reg. No. 26172–55–4) and 2-methyl-4- hydroxypropyl group-terminated, diesters isothiazolin-3-one (CAS Reg. No. 2682–20–4) with poly(2-oxepanone), diacetates (CAS mixture, at a ratio of 3 parts to 1 part, re- Reg. No. 116810–47–0) at a level not to ex- spectively, manufactured from methyl-3- ceed 0.025 weight percent of the finished mercaptopropionate (CAS Reg. No. 2935–90– coating having no greater than a 0.5 mil 2) and optionally containing magnesium thickness for use as a component of poly- nitrate (CAS Reg. No. 10377–60–3) at a con- ester, epoxy, and acrylic coatings com- centration equivalent to the isothiazolone plying with paragraphs (b)(3)(vii), (viii), active ingredients (weight/weight). For use and (xx) of this section, respectively. only as an antimicrobial agent in emul- Silver chloride-coated titanium dioxide for sion-based silicone coatings at a level not use only as a preservative in latex emul- to exceed 50 milligrams per kilogram sions at a level not to exceed 2.2 parts per (based on isothiazolone active ingredient) million (based on silver ion concentration) in the coating formulations. in the dry coating. Cyclohexanone-formaldehyde resin produced Sodium pyrophosphate. when 1 mole of cyclohexanone is made to Stannous chloride. react with 1.65 moles of formaldehyde such Stannous stearate. that the finished resin has an average mo- Stannous sulfate. lecular weight of 600–610 as determined by Stearyl alcohol. ASTM method D2503–82, ‘‘Standard Test 2-Sulfoethyl methacrylate, sodium salt (CAS Method for Molecular Weight (Relative Reg. No. 1804–87–1). For use only in copoly- Molecular Mass) of Hydrocarbons by Ther- mer coatings on metal under conditions of moelectric Measurement of Vapor Pres- use E, F, and G described in table 2 of para- sure,’’ which is incorporated by reference. graph (d) of this section, and limited to use Copies may be obtained from the American at a level not to exceed 2.0 percent by Society for Testing Materials, 1916 Race weight of the dry copolymer coating. St., Philadelphia, PA 19103, or may be ex- Tetrasodium pyrophosphate.

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Tridecyl alcohol produced from for use in contact with aqueous foods tetrapropylene by the oxo process, for use and alcoholic foods containing not only as a processing aid in polyvinyl chlo- more than 20 percent (by volume) of al- ride resins. cohol under conditions of use D, E, F, Trimethylolpropane (CAS Reg. No. 77–99–6). For use as a pigment dispersant at levels and G described in table 2 of § 176.170 of not to exceed 0.45 percent by weight of the this chapter. The resin shall contain no pigment. more than 30 weight percent of 2,2-di- Vinyl acetate-dibutyl maleate copolymers methyl-1,3-propanediol. produced when vinyl acetate and dibutyl (c) The coating in the finished form maleate are copolymerized with or without in which it is to contact food, when ex- one of the monomers: Acrylic acid or tracted with the solvent or solvents glycidyl methacrylate. For use only in characterizing the type of food, and coatings for metal foil used in contact with foods that are dry solids with the surface under conditions of time and tempera- containing no free fat or oil. The finished ture characterizing the conditions of copolymers shall contain at least 50 its intended use as determined from ta- weight-percent of polymer units derived bles 1 and 2 of paragraph (d) of this sec- from vinyl acetate and shall contain no tion, shall yield chloroform-soluble ex- more than 5 weight-percent of total poly- tractives, corrected for zinc extractives mer units derived from acrylic acid or as zinc oleate, not to exceed the fol- glycidyl methacrylate. lowing: (xxxiv) Polyamide resins derived (1) From a coating intended for or from dimerized vegetable oil acids employed as a component of a con- (containing not more than 20 percent of tainer not to exceed 1 gallon and in- monomer acids) and ethylenediamine, tended for one-time use, not to exceed as the basic resin, for use only in coat- 0.5 milligram per square inch nor to ex- ings that contact food at temperatures ceed that amount as milligrams per not to exceed room temperature. square inch that would equal 0.005 per- (xxxv) Polyamide resins having a cent of the water capacity of the con- maximum acid value of 5 and a max- tainer, in milligrams, divided by the imum amine value of 8.5 derived from area of the food-contact surface of the dimerized vegetable oil acids (con- container in square inches. From a fab- taining not more than 10 percent of ricated container conforming with the monomer acids), ethylenediamine, and description in this paragraph (c)(1), the 4,4-bis (4-hydroxyphenyl) pentanoic extractives shall not exceed 0.5 milli- acid (in an amount not to exceed 10 gram per square inch of food-contact percent by weight of said polyamide surface nor exceed 50 parts per million resins); as the basic resin, for use only of the water capacity of the container in coatings that contact food at tem- as determined by the methods provided peratures not to exceed room tempera- in paragraph (e) of this section. ture provided that the concentration of (2) From a coating intended for or the polyamide resins in the finished employed as a component of a con- food-contact coating does not exceed 5 tainer having a capacity in excess of 1 milligrams per square inch of food-con- gallon and intended for one-time use, tact surface. not to exceed 1.8 milligrams per square (xxxvi) Methacrylonitrile grafted inch nor to exceed that amount as mil- polybutadiene copolymers containing ligrams per square inch that would no more than 41 weight percent of total equal 0.005 percent of the water capac- polymer units derived from ity of the container in milligrams, di- methacrylonitrile; for use only in coat- vided by the area of the food-contact ings that are intended for contact, surface of the container in square under conditions of use D, E, F, or G inches. described in table 2 of paragraph (d) of (3) From a coating intended for or this section, with food containing no employed as a component of a con- more than 8 percent of alcohol. tainer for repeated use, not to exceed (xxxvii) Polymeric resin as a coating 18 milligrams per square inch nor to component prepared from terephthalic exceed that amount as milligrams per acid, isophthalic acid, succinic anhy- square inch that would equal 0.005 per- dride, ethylene glycol, diethylene gly- cent of the water capacity of the con- col, and 2,2-dimethyl-1,3-propanediol tainer in milligrams, divided by the

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area of the food-contact surface of the TABLE 1—TYPES OF FOOD—Continued container in square inches. II. Acidic (pH 5.0 or below), aqueous products; may contain salt or sugar or both, and including oil-in-water emulsions (4) From coating intended for re- of low- or high-fat content. peated use, and employed other than as III. Aqueous, acid or nonacid products containing free oil or a component of a container, not to ex- fat; may contain salt, and including water-in-oil emulsions ceed 18 milligrams per square inch of of low- or high-fat content. IV. Dairy products and modifications: coated surface. A. Water-in-oil emulsion, high- or low-fat. (d) Tables: B. Oil-in-water emulsion, high- or low-fat. V. Low moisture fats and oils. VI. Beverages: ABLE YPES OF OOD T 1—T F A. Containing alcohol. I. Nonacid (pH above 5.0), aqueous products; may contain B. Nonalcoholic. salt or sugar or both, and including oil-in-water emulsions VII. Bakery products. of low- or high-fat content. VIII. Dry solids (no end test required). TABLE 2—TEST PROCEDURES FOR DETERMINING THE AMOUNT OF EXTRACTIVES FROM RESINOUS OR POLYMERIC COATINGS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES

Extractant Types of food (see Condition of use 12 8 percent alcohol table 1) Water (time and Heptane (time (time and tempera- temperature) and temperature) ture)

A. High temperature heat-sterilized I, IV–B ...... 250 °F, 2 hr ...... (e.g., over 212 °F). III, IV–A, VII ...... do ...... 150 °F, 2 hr. B. Boiling water sterilized ...... II ...... 212 °F, 30 min ...... III, VII ...... do ...... 120 °F, 30 min. C. Hot filled or pasteurized above 150 II, IV–B ...... Fill boiling, cool to ...... °F. 100 °F. III, IV–A ...... do ...... V ...... 120 °F, 15 min...... do ...... D. Hot filled or pasteurized below 150 II, IV–B, VI–B ...... 150 °F, 2 hr ...... °F. III, IV–A ...... do ...... 100 °F, 30 min. 150 °F, 2 hr V ...... do ...... VI–A ...... E. Room temperature filled and stored I, II, IV–B, VI–B ..... 120 °F, 24 hr ...... (no thermal treatment in the con- III, IV–A ...... do ...... 70 °F, 30 min. 120 °F, 24 hr tainer). V, VII ...... do ...... VI–A ...... F. Refrigerated storage, no thermal I, II, III, IV–A, IV–B, 70 °F, 48 hr ...... treatment in the container). VI–B, VII. 70 °F, 48 hr VI–A ...... G. Frozen storage (no thermal treat- I, II, III, IV–B, VII ... 70 °F, 24 hr ...... ment in the container). H. Frozen storage: Ready-prepared foods intended to be reheated in container at time of use:. 1. Aqueous or oil in water emulsion I, II, IV–B ...... 212 °F, 30 min. of high or low fat. 2. Aqueous, high or low free oil or III, IV–A, VII ...... do ...... 120 °F, 30 min. fat. 1 Heptane extractant not to be used on wax-lined containers. 2 Heptane extractivity results must be divided by a factor of five in arriving at the extractivity for a food product.

(e) Analytical methods—(1) Selection of and the time-temperature exaggera- extractability conditions. First ascertain tions of the container-use conditions. the type of food product (table 1, para- Aqueous products (Types I, II, IV–B, graph (d) of this section) that is being and VI–B) require only a water- packed commercially in the test con- extractability test at the temperature tainer and the normal conditions of and time conditions shown for the thermal treatment used in packaging most severe ‘‘conditions of use.’’ Aque- the type of food involved. Using table 2 ous products with free oil or fat, and (paragraph (d) of this section), select water-oil emulsions (types III, IV–A, the food-simulating solvent or solvents and VII) will require determinations of (demineralized distilled water, both water extractability and heptane heptane, and/or 8 percent ethyl alcohol) extractability. Low-moisture fats and

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oils (type V with no free water) require this pressure for 2 hours. Slowly re- only the heptane extractability. Alco- lease the pressure, open the pressure holic beverages (type VI–A) require cooker when the pressure reads zero, only the 8 percent alcohol extractant. and composite the water of each rep- Having selected the appropriate ex- licate immediately in a clean Pyrex tractant or extractants simulating var- flask or beaker. Proceed with the de- ious types of foods and beverages and termination of the amount of extrac- the time-temperature exaggerations tives by the method described in para- over normal use, follow the applicable graph (e)(5) of this section. extraction procedure. Adapt the proce- (ii) Water (212 °F for 30 minutes), simu- dure, when necessary, for containers lating boiling water sterilization. Fill the having a capacity of over 1 gallon. container within 1⁄4-inch of the top (2) Selection of coated-container sam- with a measured volume of boiling, ples. For consumer-sized containers up demineralized distilled water. Cover to 1 gallon, quadruplicate samples of the container with clean aluminum foil representative containers (using for and place the container on a rack in a each replicate sample the number of pressure cooker in which a small containers nearest to an area of 180 amount of demineralized distilled square inches) should be selected from water is boiling. Do not close the pres- the lot to be examined. sure vent, but operate at atmospheric (3) Cleaning procedure preliminary to pressure so that there is a continuous determining the amount of extractables escape of a small amount of steam. from coated containers. Quadruplicate Continue to heat for 30 minutes, then samples of representative containers remove the test container and com- should be selected from the lot to be posite the contents of each replicate examined and must be carefully rinsed immediately in a clean Pyrex flask or to remove extraneous material prior to beaker. Proceed with the determina- the actual extraction procedure. Soda tion of the amount of extractives by fountain pressure-type hot water rins- the method described in paragraph ing equipment, consisting in its sim- (e)(5) of this section. plest form of a 1⁄8-inch–1⁄4-inch internal ° diameter metal tube attached to a hot (iii) Water (from boiling to 100 F), sim- water line and bent so as to direct a ulating hot fill or pasteurization above 150 ° 1 stream of water upward, may be used. F. Fill the container within ⁄4-inch of Be sure hot water has reached a tem- the top with a measured volume of perature of 190 °F–200 °F before starting boiling, demineralized distilled water. to rinse the container. Invert the con- Insert a thermometer in the water and tainer over the top of the fountain and allow the uncovered container to stand direct a strong stream of hot water in a room at 70 °F–85 °F. When the tem- against the bottom and all sides for 1 perature reads 100 °F, composite the minute, drain, and allow to dry. water from each replicate immediately (4) Exposure conditions—(i) Water (250 in a clean Pyrex flask or beaker. Pro- °F for 2 hours), simulating high-tempera- ceed with the determination of the ture heat sterilization. Fill the container amount of extractives by the method within 1⁄4-inch of the top with a meas- described in paragraph (e)(5) of this ured volume of demineralized distilled section. water. Cover the container with clean (iv) Water (150° for 2 hours), simulating aluminum foil and place the container hot fill or pasteurization below 150 °F. on a rack in a pressure cooker. Add a Preheat demineralized distilled water small amount of demineralized dis- to 150 °F in a clean Pyrex flask. Fill tilled water to the pressure cooker, but the container within 1⁄4-inch of the top do not allow the water to touch the with a measured volume of the 150 °F bottom of the container. Close the water and cover with clean aluminum cooker securely and start to heat over foil. Place the test container in an a suitable burner. When a steady oven maintained at 150 °F. After 2 stream of steam emerges from the hours, remove the test container from vent, close the vent and allow the pres- the oven and immediately composite sure to rise to 15 pounds per square the water of each replicate in a clean inch (250 °F) and continue to maintain Pyrex flask or beaker. Proceed with

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the determination of the amount of ex- tilled water is boiling. Do not close the tractives by the method described in pressure vent, but operate at atmos- paragraph (e)(5) of this section. pheric pressure so that there is a con- (v) Water (120 °F for 24 hours), simu- tinuous escape of a small amount of lating room temperature filling and stor- steam. Continue to heat for 30 minutes, age. Preheat demineralized distilled then remove the test container and water to 120 °F in a clean Pyrex flask. composite the contents of each rep- Fill the container within 1⁄4-inch of the licate immediately in a clean Pyrex top with a measured volume of the 120 flask or beaker. Proceed with the de- °F water and cover with clean alu- termination of the amount of extrac- minum foil. Place the test container in tives by the method described in para- an incubator or oven maintained at 120 graph (e)(5) of this section. ° F. After 24 hours, remove the test con- (ix) Heptane (150 °F for 2 hours) simu- tainer from the incubator and imme- lating high-temperature heat sterilization diately composite the water of each for fatty foods only. Preheat redistilled replicate in a clean Pyrex flask or reagent-grade heptane (boiling point beaker. Proceed with the determina- 208 °F) carefully in a clean Pyrex flask tion of the amount of extractives by on a water bath or nonsparking hot the method described in paragraph plate in a well-ventilated hood to 150 (e)(5) of this section. °F. At the same time preheat a pres- (vi) Water (70 °F for 48 hours), simu- sure cooker or equivalent to 150 °F in lating refrigerated storage. Bring an incubator. This pressure cooker is demineralized distilled water to 70 °F to serve only as a container for the in a clean Pyrex flask. Fill the con- heptane-containing test package inside tainer within 1⁄4-inch of the top with a the incubator in order to minimize the measured volume of the 70 °F water, and cover with clean aluminum foil. danger of explosion. Fill the test con- 1 Place the test container in a suitable tainer within ⁄4-inch of the top with a ° room maintained at 70 °F. After 48 measured volume of the 150 F heptane hours, immediately composite the and cover with clean aluminum foil. water of each replicate in a clean Place the test container in the Pyrex flask or beaker. Proceed with preheated pressure cooker and then put ° the determination of the amount of ex- the assembly into a 150 F incubator. tractives by the method described in After 2 hours, remove the pressure paragraph (e)(5) of this section. cooker from the incubator, open the as- (vii) Water (70 °F for 24 hours), simu- sembly, and immediately composite lating frozen storage. Bring the heptane of each replicate in a clean demineralized distilled water to 70 °F Pyrex flask or beaker. Proceed with in a clean Pyrex flask. Fill the con- the determination of the amount of ex- tainer within 1⁄4-inch of the top with a tractives by the method described in measured volume of the 70 °F water paragraph (e)(5) of this section. and cover with clean aluminum foil. (x) Heptane (120 °F for 30 minutes), sim- Place the container in a suitable room ulating boiling water sterilization of fatty maintained at 70 °F. After 24 hours, im- foods only. Preheat redistilled reagent- mediately composite the water of each grade heptane (boiling point 208 °F) replicate in a clean Pyrex flask or carefully in a clean Pyrex flask on a beaker. Proceed with the determina- water bath or nonsparking hot plate in tion of the amount of extractives by a well-ventilated hood to 120 °F. At the the method described in paragraph same time, preheat a pressure cooker (e)(5) of this section. or equivalent to 120 °F in an incubator. (viii) Water (212 °F for 30 minutes), sim- This pressure cooker is to serve only as ulating frozen foods reheated in the con- a vented container for the heptane-container. Fill the container to within 1⁄4- taining test package inside the incu- inch of the top with a measured volume bator in order to minimize the danger of boiling, demineralized distilled of explosion. Fill the test container water. Cover the container with clean within 1⁄4-inch of the top with a meas- aluminum foil and place the container ured volume of the 120 °F heptane and on a rack in a pressure cooker in which cover with clean aluminum foil. Place a small amount of demineralized dis- the test container in the preheated

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pressure cooker and then put the as- cooker from the incubator, open the assembly into a 120 °F incubator. After 30 sembly and immediately composite the minutes, remove the pressure cooker heptane of each replicate in a clean from the incubator, open the assembly, Pyrex flask or beaker. Proceed with and immediately composite the the determination of the amount of ex- heptane of each replicate in a clean tractives by the method described in Pyrex flask or beaker. Proceed with paragraph (e)(5) of this section. the determination of the amount of ex- (xiii) Heptane (70 °F for 30 minutes), tractives by the method described in simulating room temperature filling and paragraph (e)(5) of this section. storage of fatty foods only. Fill the test (xi) Heptane (120 °F for 15 minutes), container within 1⁄4-inch of the top simulating hot fill or pasteurization above with a measured volume of the 70 °F 150 °F for fatty foods only. Preheat re- heptane and cover with clean alu- distilled reagent-grade heptane (boiling minum foil. Place the test container in point 208 °F) carefully in a clean Pyrex a suitable room maintained at 70 °F. flask on a water bath or nonsparking After 30 minutes, composite the hot plate in a well-ventilated hood to heptane of each replicate in a clean 120 °F. At the same time, preheat a Pyrex flask or beaker. Proceed with pressure cooker or equivalent to 120 °F the determination of the amount of ex- in an incubator. This pressure cooker tractives by the method described in is to serve only as a container for the paragraph (e)(5) of this section. heptane-containing test package inside (xiv) Heptane (120 °F for 30 minutes), the incubator in order to minimize the simulating frozen fatty foods reheated in danger of explosion. Fill the test con- the container. Preheat redistilled rea- tainer within 1⁄4-inch of the top with a gent-grade heptane (boiling point 208 measured volume of the 120 °F heptane °F) carefully in a clean Pyrex flask on and cover with clean aluminum foil. a water bath or hot plate in a well-ven- Place the test container in the tilated hood to 120 °F. At the same preheated pressure cooker and then put time, preheat a pressure cooker to 120 the assembly into a 120 °F incubator. °F in an incubator. This pressure cook- After 15 minutes, remove the pressure er is to serve only as a container for cooker from the incubator, open the as- the heptane-containing test package sembly, and immediately composite inside the incubator in order to mini- the heptane of each replicate in a clean mize the danger of explosion. Fill the Pyrex flask or beaker. Proceed with test container within 1⁄4-inch of the top the determination of the amount of ex- with a measured volume of the 120 °F tractives by the method described in heptane and cover with clean alu- paragraph (e)(5) of this section. minum foil. Place the test container in (xii) Heptane (100 °F for 30 minutes), the preheated pressure cooker and then simulating hot fill or pasteurization below put the assembly into a 120 °F incu- 150 °F for fatty foods only. Preheat re- bator. After 30 minutes, remove the distilled reagent-grade heptane (boiling pressure cooker from the incubator, point 208 °F) carefully in a clean Pyrex open the assembly and immediately flask on a water bath or nonsparking composite the heptane from each rep- hot plate in a well-ventilated hood to licate into a clean Pyrex flask. Proceed 100 °F. At the same time, preheat a with the determination of the amount pressure cooker or equivalent to 100 °F of extractives by the method described in an incubator. This pressure cooker in paragraph (e)(5) of this section. is to serve only as a container for the (xv) Alcohol—8 percent (150 °F for 2 heptane-containing test package inside hours), simulating alcoholic beverages hot the incubator in order to minimize the filled or pasteurized below 150 °F. Pre- danger of explosion. Fill the test con- heat 8 percent (by volume) ethyl alco- tainer within 1⁄4-inch of the top with a hol in demineralized distilled water to measured volume of the 100 °F heptane 150 °F in a clean Pyrex flask. Fill the and cover with clean aluminum foil. test container with within 1⁄4-inch of Place the test container in the the top with a measured volume of the preheated pressure cooker and then put 8 percent alcohol. Cover the container the assembly into a 100 °F incubator. with clean aluminum foil and place in After 30 minutes, remove the pressure an oven maintained at 150 °F. After 2

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hours, remove the container from the rate to a few milliliters on a non- oven and immediately composite the sparking low-temperature hotplate. alcohol from each replicate in a clean The last few milliliters should be evap- Pyrex flask. Proceed with the deter- orated in an oven maintained at a tem- mination of the amount of extractives perature of 212 °F. Cool the platinum by the method described in paragraph dish in a desiccator for 30 minutes and (e)(5) of this section. weigh the residue to the nearest 0.1 (xvi) Alcohol—8 percent (120 °F for 24 milligram (e). Calculate the extractives hours), simulating alcoholic beverages in milligrams per square inch and in room-temperature filled and stored. Pre- parts per million for the particular size heat 8 percent (by volume) ethyl alco- of container being tested and for the hol in demineralized distilled water to specific food-simulating solvent used. 120 °F in a clean Pyrex flask. Fill the (a) Water and 8-percent alcohol. test container within 1⁄4-inch of the top with a measured volume of the 8 per- Milligrams extractives e cent alcohol, cover the container with = clean aluminum foil and place in an per square inch s ° oven or incubator maintained at 120 F. Ex= ( e )( a )(1000) After 24 hours, remove the container Extractives residue = from the oven or incubator and imme- ()()cs diately composite the alcohol from each replicate into a clean Pyrex flask. (b) Heptane. Proceed with the determination of the e amount of extractives by the method Milligrams extractives = described in paragraph (e)(5) of this per square inch section. ()()sF (xvii) Alcohol—8 percent (70 °F for 48 Ex= ( e )( a )(1000) hours), simulating alcoholic beverages in Extractives residue = refrigerated storage. Bring 8 percent (by volume) ethyl alcohol in demineralized ()()()csF distilled water to 70 °F in a clean Pyrex where: flask. Fill the test container within 1⁄4- Ex=Extractives residue in ppm for any con- inch of the top with a measured volume tainer size. of the 8 percent alcohol. Cover the con- e=Milligrams extractives per sample tested. tainer with clean aluminum foil. Place a=Total coated area, including closure in the test container in a suitable room square inches. maintained at 70 °F. After 48 hours, im- c=Water capacity of container, in grams. mediately composite the alcohol from s=Surface of coated area tested, in square inches. each replicate into a clean Pyrex flask. F=Five, the ratio of the amount of extrac- Proceed with the determination of the tives removed from a coated container by amount of extractives by the method heptane under exaggerated time-tempera- described in paragraph (e)(5) of this ture test conditions compared to the section. amount extracted by a fat or oil from a container tested under exaggerated condi- NOTE: The tests specified in paragraph tions of thermal sterilization and use. (e)(4) (i) through (xvii) of this section are ap- e′=Chloroform-soluble extractives residue. plicable to flexible packages consisting of ′ coated metal contacting food, in which case ee =Zinc corrected chloroform-soluble ex- the closure end is double-folded and clamped tractive residue. ′ ′ with metal spring clips by which the package e or ee is substituted for e in the above equa- can be suspended. tions when necessary. (5) Determination of amount of extrac- If when calculated by the equations in tives—(i) Total residues. Evaporate the paragraph (e)(5)(i) (a) and (b) of this food-simulating solvents from para- section, the concentration of extrac- graph (e)(4) (i) to (xvii), inclusive, of tives residue (Ex) exceeds 50 parts per this section to about 100 milliliters in million or the extractives in milli- the Pyrex flask and transfer to a clean, grams per square inch exceed the limi- tared platinum dish, washing the flask tations prescribed in paragraph (c) of three times with the solvent used in this section for the particular con- the extraction procedure, and evapo- tainer size, proceed to paragraph

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(e)(5)(ii) of this section (method for de- million and must not exceed in milli- termining the amount of chloroform- grams per square inch the limitations soluble extractives residue). for the particular article as prescribed (ii) Chloroform-soluble extractives resin paragraph (c) of this section. idue. Add 50 milliliters of chloroform (f) Equipment and reagent require- (freshly distilled reagent grade or a ments—(1) Equipment. grade having an established consist- Rinsing equipment, soda fountain pressure- ently low blank) to the dried and type hot water, consisting in simplest form weighed residue, (e), in the platinum of a 1⁄8-inch–1⁄4-inch inside diameter metal dish, obtained in paragraph (e)(5)(i) of tube attached to a hot water line delivering this section. Warm carefully, and filter 190 °F–200 °F water and bent so as to direct through Whatman No. 41 filter paper in a stream of water upward. a Pyrex funnel, collecting the filtrate Pressure cooker, 21-quart capacity with pressure gage, safety release, and removable in a clean, tared platinum dish. Repeat rack, 12.5 inches inside diameter × 11 inches the chloroform extraction, washing the inside height, 20 pounds per square inch safe filter paper with this second portion of operating pressure. chloroform. Add this filtrate to the Oven, mechanical convection, range to in- original filtrate and evaporate the clude 120 °F–212 °F explosion-proof, inside di- total down to a few milliliters on a mensions (minimum), 19″ × 19″ × 19″, constant ± ° low-temperature hotplate. The last few temperature to 2 F (water bath may be substituted). milliliters should be evaporated in an Incubator, inside dimensions (minimum) oven maintained at 212 °F. Cool the 19″ × 19″ × 19″ for use at 100 °F±2 °F explosion platinum dish in a desiccator for 30 proof (water bath may be substituted). minutes and weigh to the nearest 0.1 Constant-temperature room or chamber 70 milligram to get the chloroform-solu- °F±2 °F minimum inside dimensions 19″ × 19″ ble extractives residue (e′). This e′ is × 19″. substituted for e in the equations in Hot plate, nonsparking (explosion proof), top 12″ × 20″, 2,500 watts, with temperature paragraph (e)(5)(i) (a) and (b) of this control. section. If the concentration of extrac- Platinum dish, 100-milliliter capacity min- tives (Ex) still exceeds 50 parts per mil- imum. lion or the extractives in milligrams All glass, Pyrex or equivalent. per square inch exceed the limitations (2) Reagents. prescribed in paragraph (c) of this section for the particular container size, Water, all water used in extraction proce- proceed as follows to correct for zinc dure should be freshly demineralized (deion- extractives (‘‘C’’ enamels only): Ash ized) distilled water. Heptane, reagent grade, freshly redistilled the residue in the platinum dish by before use, using only material boiling at 208 heating gently over a Meeker-type °F. burner to destroy organic matter and Alcohol, 8 percent (by volume), prepared hold at red heat for about 1 minute. from undenatured 95 percent ethyl alcohol Cool in the air for 3 minutes, and place diluted with demineralized or distilled the platinum dish in the desiccator for water. 30 minutes and weigh to the nearest 0.1 Chloroform, reagent grade, freshly redistilled before use, or a grade having an estab- milligram. Analyze this ash for zinc by lished, consistently low blank. standard Association of Official Agri- Filter paper, Whatman No. 41 or equiva- cultural Chemists methods or equivalent. lent. Calculate the zinc in the ash as (g) In accordance with good manufac- zinc oleate, and subtract from the turing practice, finished coatings in- weight of chloroform-soluble extrac- tended for repeated food-contact use tives residue (e′) to obtain the zinc-cor- shall be thoroughly cleansed prior to rected chloroform-soluble extractives ′ ′ their first use in contact with food. residue (ee ). This ee is substituted for (h) Acrylonitrile copolymers identi- e in the formulas in paragraph (e)(5)(i) fied in this section shall comply with (a) and (b) of this section. To comply the provisions of § 180.22 of this chap- with the limitations in paragraph (c) of ter. this section, the chloroform-soluble extractives residue (but after correction [42 FR 14534, Mar. 15, 1977] for the zinc extractives in case of ‘‘C’’ EDITORIAL NOTE: For FEDERAL REGISTER ci- enamels) must not exceed 50 parts per tations affecting § 175.300, see the List of CFR

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Sections Affected, which appears in the with § 177.1520 of this chapter. The base Finding Aids section of the printed volume polyolefin film may contain optional and on GPO Access. adjuvant substances permitted for use § 175.320 Resinous and polymeric coat- in polyolefin film by applicable regula- ings for polyolefin films. tions in parts 170 through 189 of this chapter. Resinous and polymeric coatings may be safely used as the food-contact (b) The coatings are formulated from surface of articles intended for use in optional substances which are: producing, manufacturing, packing, (1) Substances generally recognized processing, preparing, treating, pack- as safe for use in or on food. aging, transporting, or holding food, in (2) Substances the use of which is accordance with the following pre- permitted under applicable regulations scribed conditions: in parts 170 through 189 of this chapter, (a) The coating is applied as a contin- by prior sanctions, or approvals. uous film over one or both sides of a (3) Substances identified in this para- base film produced from one or more of graph (b)(3) and subject to such limita- the basic olefin polymers complying tions as are provided:

List of substances Limitations

(i) Resins and polymers: Acrylic acid polymer and its ethyl or methyl esters. Acrylamide copolymerized with ethyl acrylate and/or styrene and/or methacrylic acid, and the copolymer subsequently reacted with formaldehyde and butanol. Butadiene-acrylonitrile copolymer. Butadiene-acrylonitrile-styrene terpolymer. Butyl rubber. N,N′-Diphenyl-p-phenylenediamine ...... For use only as a polymerization inhibitor in 2-sulfoethyl methacrylate, sodium salt. 2-Ethylhexyl acrylate copolymerized with one or more of the following: Acrylonitrile. Itaconic acid. Methacrylonitrile. Methyl acrylate. Methyl methacrylate. 4,4′-Isopropylidenediphenolepichlorohydrin average molecular weight 900. Melamine-formaldehyde as the basic polymer or chemically modified with methyl alcohol. Methacrylic acid and its ethyl or methyl esters copolymerized with one or more of the following: Acrylic acid. Ethyl acrylate. Methyl acrylate. a-Methyl styrene polymer. a-Methylstyrene-vinyltoluene copolymer resins (molar ratio For use only in coatings that contact food under conditions of 1 a-methylstyrene to 3 vinyltoluene). use D, E, F, or G described in table 2 of § 176.170(c) of this chapter, provided that the concentration of a-methylstyrene- vinyltoluene copolymer resins in the finished food-contact coating does not exceed 1.0 milligram per square inch of food-contact surface. Petroleum alicyclic hydrocarbon resins ...... As defined in § 176.170 of this chapter. Blended with butyl rubber for use as a component of coatings on polyolefin fabric for bulk packaging of raw fruits and vegetables and used at a level not to exceed 30 percent by weight of the total coating solids. Polyamide resins (CAS Reg. No. 68139–70–8), as the For use only in coatings for polypropylene films that contact basic resin, derived from: food at temperatures not to exceed room temperature. Dimerized vegetable oil or tall oil acids containing not more than 20 percent of monomer acids. Azelaic acid (CAS Reg. No. 123–99–9) in an amount not to exceed 3.7 percent by weight of the polyamide resin. Ethylenediamine (CAS Reg. No. 107–15–3). Piperazine (CAS Reg. No. 110–85–0) in an amount not to exceed 6.4 percent by weight of the polyamide resin.

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List of substances Limitations

Polyamide resins, derived from dimerized vegetable oil For use only in coatings for polyolefin films that contact food at acids (containing not more than 20% of monomer acids) temperatures not to exceed room temperature. and ethylenediamine, as the basic resin. Polyamide resins having a maximum acid value of 5 and a For use only in coatings that contact food at temperatures not maximum amine value of 8.5 derived from dimerized to exceed room temperature provided that the concentration vegetable oil acids (containing not more than 10 percent of the polyamide resins in the finished food-contact coating of monomer acids), ethylenediamine, and 4,4-bis (4- does not exceed 5 milligrams per square inch of food-con- hydroxyphenyl) pentanoic acids (in an amount not to ex- tact surface. ceed 10 percent by weight of said polyamide resins); as the basic resin. Polyester resins formed by reaction of one or more of the following polybasic acids and monobasic acids with one or more of the following polyhydric alcohols: Polybasic acids: Adipic. Azelaic ...... For use in forming polyester resins intended for use in coatings that contact food only of the type identified in § 176.170(c) of this chapter, table 1, under Category VIII, and under conditions of use E, F, or G, described in table 2 of § 176.170(c) of this chapter. Dimerized fatty acids derived from: Animal, marine or vegetable fats and oils. Tall oil. Fumaric. Isophthalic. Maleic. o-Phthalic. Sebacic. Terephthalic. Trimellitic. Monobasic acids: Fatty acids derived from: Animal, marine, or vegetable fats and oils. Gum rosin ...... As defined in § 178.3870 of this chapter. For use in forming polyester resins intended for use in coatings that contact food only of the type identified in § 176.170(c) of this chapter, table 1, under Category VIII, and under conditions of use E, F, or G described in table 2 of § 176.170(c) of this chapter. Polyhydric alcohols: 1,3-Butylene glycol. Diethylene glycol. 2,2-Dimethyl-1,3-propanediol. Dipropylene glycol. Ethylene glycol. Glycerol. Mannitol. a-Methyl glucoside. Pentaerythritol. Propylene glycol. Sorbitol. Trimethylol ethane. Trimethylol propane. Polyethylenimine ...... For use only as a primer subcoat to anchor epoxy surface coatings to the base sheet. Polystyrene. Polyvinyl acetate. Polyvinyl chloride ...... Siloxanes and silicones: platinum-catalyzed reaction product of Platinum content not to exceed 150 parts per million. vinyl-containing dimethylpolysiloxane (CAS Reg. No. 68083– 18–1 and CAS Reg. No. 68083–19–2) with methylhydrogen polysiloxane (CAS Reg. No. 63148–57–2) and dimethylmethylhydrogen polysiloxane (CAS Reg. No. 68037– 59–2). The following substances may be used as optional polymerization inhibitors:. 3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. 107–54–0), at a level not to exceed 0.53 weight percent;. 1-Ethynylcyclohexene (CAS Reg. No. 931–49–7), at a level not to exceed 0.64 weight percent;. Bis(methoxymethyl)ethyl maleate (CAS Reg. No. 102054–10–4), at a level not to exceed 1.0 weight percent;. Methylvinyl cyclosiloxane (CAS Reg. No. 68082–23–5); and.

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List of substances Limitations

Tetramethyltetravinylcyclotetrasiloxane (CAS Reg. No. 2554–06–5).. Siloxanes and silicones; platinum-catalyzed reaction product of Platinum content not to exceed 100 parts per million. For use vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a surface coating under the following conditions: 68083–19–2 and 68083–18–1), with methyl hydrogen 1. In coatings for olefin polymers provided the coating contacts polysiloxane (CAS Reg. No. 63148–57–2). Dimethyl maleate food only of the types identified in § 176.170(c) of this chap- (CAS Reg. No. 624–48–6) and vinyl acetate (CAS Reg. No. ter, table 1, under Types I, II, VI, and VII–B when used 108–05–4) may be used as optional polymerization inhibitors. under conditions of use E, F, and G described in table 2 in § 176.170(c) of this chapter. 2. In coatings for olefin polymers provided the coating contacts food only of the types identified in § 176.170(c) of this chapter, table 1, under Types III, IV, V, VII–A, VIII, and IX when used under conditions of use A through H described in table 2 in § 176.170(c) of this chapter. Siloxanes and silicones; platinum-catalyzed reaction product of Platinum content not to exceed 100 parts per million. For use vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a release coating for pressure sensitive adhesives. 68083–19–2 and 68083–18–1), with methyl hydrogen polysiloxane (CAS Reg. No. 63148–57–2). Dimethyl maleate (CAS Reg. No. 624–48–6), vinyl acetate (CAS Reg. No. 108–05–4), dibutyl maleate (CAS Reg. No. 105–76–0) and diallyl maleate (CAS Reg. No. 999–21–3) may be used as optional polymerization inhibitors. The polymer may also contain C16-C18 olefins (CAS Reg. No. 68855–60–7) as a control release agent. Styrene copolymerized with one or more of the following: Acrylonitrile. a-Methyl styrene. Styrene polymers made by the polymerization of any com- For use only in contact with foods of Types IV–A, V, and VII in bination of styrene or alpha methyl styrene with acrylic table 1 of § 176.170(c) of this chapter, under use conditions acid, methacrylic acid, 2-ethyl hexyl acrylate, methyl E through G in table 2 of § 176.170(c), and with foods of methacrylate, and butyl acrylate. The styrene and alpha Types VIII and IX without use temperature restriction. methyl styrene, individually, may constitute from 0 to 80 weight percent of the polymer. The other monomers, individually, may be from 0 to 40 weight percent of the polymer. The polymer number average molecular weight (Mn) shall be at least 2,000 (as determined by gel permeation chromatography). The acid number of the polymer shall be less than 250. The monomer content shall be less than 0.5 percent. Styrene-isobutylene copolymer. Terpene resins consisting of polymers of a-pinene, b-pinene, and/or dipentene; acid value less than 5, saponification number less than 5, and color less than 4 on the Gardner scale as measured in 50 percent mineral spirits solution. 2-Sulfoethyl methacrylate, sodium salt Chemical Abstracts For use only in copolymer coatings under conditions of use E, Service No. 1804–87–1]. F, and G described in table 2 of § 176.170(c) of this chapter and limited to use at a level not to exceed 2.0 percent by weight of the dry copolymer coating. Vinyl chloride-acetate, hydroxyl-modified copolymer or maleic acid-modified copolymer. Vinyl chloride copolymerized with one or more of the following: Acrvlonitrile. Vinyl acetate. Vinylidene chloride. Vinylidene chloride copolymerized with one or more of the following: Acrylic acid and its methyl, ethyl, propyl, butyl, or octyl esters. Acrylonitrile. Itaconic acid. Methacrylic acid and its methyl, ethyl, propyl, butyl, or octyl esters. Methacrylonitrile. Vinyl chloride. (ii) Plasticizers: Acetyl tributyl citrate. Acetyl triethyl citrate. Butyl phthalyl butyl glycolate. Butyl stearate. Dibutyl sebacate. Diethyl phthalate. 2-Ethylhexyl diphenyl phosphate.

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List of substances Limitations

Ethyl phthalyl ethyl glycolate. Glycerol monooleate ...... Glycerol triacetate. Triethyl citrate. (iii) Adjuvants (release agents, waxes, and dispersants): Acetone. Amides (unsubstituted) of fatty acids from vegetable or animal oils. n-Butyl acetate. n-Butyl alcohol. Candelilla wax. Carnauba wax. 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172– For use only as an antimicrobial agent in emulsion-based sili- 55–4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. cone coatings at a level not to exceed 50 milligrams per kilo- 2682–20–4) mixture, at a ratio of 3 parts to 1 part, respec- gram (based on isothiazolone active ingredient) in the coat- tively, manufactured from methyl-3-mercaptopropionate (CAS ing formulation. Reg. No. 2935–90–2) and optionally containing magnesium nitrate (CAS Reg. No. 10377–60–3) at a concentration equivalent to the isothiazolone active ingredients (weight/ weight).. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65– For use as an antimicrobial agent at levels not to exceed 500 7). milligrams per kilogram in emulsion-based silicone coating. Ethyl acetate. Fatty acids from vegetable or animal oils and their aluminum, ammonium, calcium, magnesium, and sodium salts. Hexane. Methyl ethyl ketone. N,N′-Dioleoylethylenediamine (CAS Reg. No. 110–31–6) ... For use only in ionomeric resins complying with § 177.1330 of this chapter and in ethylene vinyl acetate copolymers complying with § 177.1350 of this chapter at a level not to exceed 0.0085 milligram per square centimeter (0.055 milligram per square inch) in the finished food-contact article. Petroleum waxes conforming to specifications included in a regulation in subchapter B of this chapter. Polyvinyl alcohol, minimum viscosity of 4% aqueous solu- For use only as a dispersing agent at levels not to exceed 6% tion at 20 °C of 4 centipoises and percent alcoholysis of of total coating weight in coatings for pol-yolefin films pro- 87–100. vided the finished polyolefin films contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types V, VIII, and IX. Sodium dioctyl sulfosuccinate. Sodium dodecylbenzenesulfonate. Sodium lauryl sulfate. Sorbitan and sorbitol esters of fatty acids from vegetable or animal oils. Spermaceti wax. Tetrahydrofuran. Toluene. (iv) Preservatives: Silver chloride-coated titanium dioxide ...... For use only as a preservative in latex emulsions at a level not to exceed 2.2 parts per million (based on silver ion concentration) in the dry coating.

(c) The coating in the finished form the provisions of § 180.22 of this chap- in which it is to contact food, when ex- ter. tracted with the solvent or solvents [42 FR 14534, Mar. 15, 1977, as amended at 43 characterizing the type of food, and FR 7206, Feb. 21, 1978; 45 FR 6541, Jan. 29, under conditions of time and tempera- 1980; 47 FR 22512, May 25, 1982; 49 FR 36497, ture characterizing the conditions of Sept. 18, 1984; 50 FR 47209, Nov. 15, 1985; 56 FR its intended use as determined from ta- 49674, Oct. 1, 1991; 61 FR 14246, Apr. 1, 1996; 63 bles 1 and 2 of § 176.17(c) of this chapter, FR 71017, Dec. 23, 1998; 64 FR 2568, Jan. 15, shall yield net chloroform-soluble ex- 1999; 65 FR 6892, Feb. 11, 2000; 65 FR 37041, tractives not to exceed 0.5 milligram June 13, 2000] per square inch of coated surface. (d) Acrylonitrile copolymers identified in this section shall comply with

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§ 175.350 Vinyl acetate/crotonic acid used as a coating or as a component of copolymer. a coating for polyolefin films for pack- A copolymer of vinyl acetate and aging bakery products and confec- crotonic acid may be safely used as a tionery. coating or as a component of a coating which is the food-contact surface of § 175.360 Vinylidene chloride copolymer coatings for nylon film. polyolefin films intended for packaging food, subject to the provisions of this Vinylidene chloride copolymer coat- section. ings identified in this section and ap- (a) The copolymer may contain added plied on nylon film may be safely used optional substances to impart desired as food-contact surfaces, in accordance properties. with the following prescribed condi- (b) The quantity of any optional sub- tions: stance does not exceed the amount rea- (a) The coating is applied as a contin- sonably required to accomplish the in- uous film over one or both sides of a tended physical or technical effect nor base film produced from nylon resins any limitations further provided. complying with § 177.1500 of this chap- (c) Any optional substance that is ter. the subject of a regulation in parts 174, (b) The coatings are prepared from 175, 176, 177, 178, and § 179.45 of this vinylidene chloride copolymers pro- chapter conforms with any specifica- duced by copolymerizing vinylidene tions in such regulation. chloride with one or more of the mono- (d) Optional substances as provided mers acrylic acid, acrylonitrile, ethyl in paragraph (a) of this section include: acrylate, methacrylic acid, methyl ac- (1) Substances generally recognized rylate, methyl methacrylate (CAS Reg. as safe in food. No. 80–62–6; maximum use level 6 (2) Substances subject to prior sanc- weight percent) and 2-sulfoethyl meth- tion or approval for uses with a copoly- acrylate (CAS Reg. No. 10595–80–9; max- mer of vinyl acetate and crotonic acid imum use level 1 weight percent). The and used in accordance with such sanc- finished copolymers contain at least 50 tion or approval. weight percent of polymer units de- (3) Substances identified in this sub- rived from vinylidene chloride. The fin- paragraph and subject to such limita- ished coating produced from vinylidene tions as are provided: chloride copolymers produced by co- List of substances Limitations polymerizing vinylidene chloride with methyl methacrylate and/or 2- Silica. sulfoethyl methacrylate, or with meth- Japan wax. yl methacrylate and/or 2-sulfoethyl (e) Copolymer of vinyl acetate and methacrylate together with one or crotonic acid used as a coating or as a more of the other monomers from this component of a coating conforming section, is restricted to use at or below with the specifications of paragraph room temperature. (e)(1) of this section are used as pro- (c) Optional adjuvant substances em- vided in paragraph (e)(2) of this sec- ployed in the production of the coat- tion. ings or added thereto to impart desired (1) Specifications. (i) The chloroform- properties may include sodium soluble portion of the water extractives dodecylbenzenesulfonate. of the coated film obtained with dis- (d) The coating in the finished form tilled water at 120 °F for 24 hours does in which it is to contact food, when ex- not exceed 0.5 milligram per square tracted with the solvent or solvents inch of coated surface. characterizing the type of food, and (ii) The chloroform-soluble portion of under conditions of time and tempera- the n-heptane extractives of the coated ture characterizing the conditions of film obtained with n-heptane at 70 °F its intended use as determined from ta- for 30 minutes does not exceed 0.5 milli- bles 1 and 2 of § 176.170(c) of this chap- gram per square inch of coated surface. ter, shall yield net chloroform-soluble (2) Conditions of use. The copolymer extractives not to exceed 0.5 milligram of vinyl acetate and crotonic acid is per square inch of coated surface when

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tested by the methods described in § 175.380 Xylene-formaldehyde resins § 176.170(d) of this chapter. condensed with 4,4′- (e) Acrylonitrile copolymers identi- isopropylidenediphenol- fied in this section shall comply with epichlorohydrin epoxy resins. the provisions of § 180.22 of this chap- The resins identified in paragraph (a) ter. of this section may be safely used as a [42 FR 14534, Mar. 15, 1977, as amended at 43 food-contact coating for articles in- FR 7206, Feb. 21, 1978; 45 FR 76998, Nov. 21, tended for use in contact with food, in 1980; 47 FR 54430, Dec. 3, 1982] accordance with the following prescribed conditions. § 175.365 Vinylidene chloride copoly- (a) The resins are produced by the mer coatings for polycarbonate film. condensation of xylene-formaldehyde resin and 4,4′-isopropylidenediphenol- Vinylidene chloride copolymer coat- epichlorohydrin epoxy resins, to which ings identified in this section and ap- may have been added certain optional plied on polycarbonate film may be adjuvant substances required in the safely used as food-contact surfaces, in production of the resins or added to im- accordance with the following pre- part desired physical and technical scribed conditions: properties. The optional adjuvant sub- (a) The coating is applied as a contin- stances may include resins produced by uous film over one or both sides of a the condensation of allyl ether of base film produced from polycarbonate mono-, di-, or trimethylol phenol and resins complying with § 177.1580 of this capryl alcohol and also may include chapter. substances identified in § 175.300(b)(3), (b) The coatings are prepared from with the exception of paragraph (b)(3) vinylidene chloride copolymers pro- (xxxi) and (xxxii) of that section. duced by copolymerizing vinylidene chloride with acrylonitrile, methyl ac- (b) The resins identified in paragraph rylate, and acrylic acid. The finished (a) of this section may be used as a copolymers contain at least 50 weight- food-contact coating for articles in- percent of polymer units derived from tended for contact at temperatures not ° vinyldene chloride. to exceed 160 F with food of Types I, (c) Optional adjuvant substances em- II, VI–A and B, and VIII described in ployed in the production of the coat- table 1 of § 176.170(c) of this chapter ings or added thereto to impart desired provided that the coating in the fin- properties may include sodium ished form in which it is to contact dodecylbenzenesulfonate in addition to food meets the following extractives substances described in § 174.5(d) of this limitations when tested by the meth- chapter. ods provided in § 175.300(e): (d) The coating in the finished form (1) The coating when extracted with in which it is to contact food, when ex- distilled water at 180 °F for 24 hours tracted with the solvent or solvents yields total extractives not to exceed characterizing the type of food, and 0.05 milligram per square inch of food- under the conditions of time and tem- contact surface. perature characterizing the conditions (2) The coating when extracted with 8 of its intended use as determined from percent (by volume) ethyl alcohol in tables 1 and 2 of § 176.170(c) of this chap- distilled water at 160 °F for 4 hours ter, shall yield net chloroform-soluble yields total extractives not to exceed extractives in each extracting solvent 0.05 milligram per square inch of food- not to exceed 0.5 milligram per square contact surface. inch of coated surface as determined by (c) The resins identified in paragraph the methods described in § 176.170(d) of (a) of this section may be used as a this chapter. In testing the finished food-contact coating for articles in- food-contact articles, a separate test tended for contact at temperatures not sample is to be used for each required to exceed room temperature with food extracting solvent. of Type VI–C described in table 1 of (e) Acrylonitrile copolymers identi- § 176.170(c) of this chapter provided the fied in this section shall comply with coating in the finished form in which it the provisons of § 180.22 of this chapter. is to contact food meets the following

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extractives limitations when tested by tractives not to exceed 0.025 milligram the methods provided in § 175.300(e): per square inch of surface; and chro- (1) The coating when extracted with mium extractives not to exceed 0.05 distilled water at 180 °F for 24 hours microgram per square inch of surface. yields total extractives not to exceed (e) The coatings are used as food-con- 0.05 milligram per square inch of food- tact surfaces for bulk reusable con- contact surface. tainers intended for storing, handling, (2) The coating when extracted with and transporting food. 50 percent (by volume) ethyl alcohol in distilled water at 180 °F for 24 hours PART 176—INDIRECT FOOD ADDI- yields total extractives not to exceed TIVES: PAPER AND PAPERBOARD 0.05 milligram per square inch. COMPONENTS § 175.390 Zinc-silicon dioxide matrix coatings. Subpart A [Reserved] Zinc-silicon dioxide matrix coatings Subpart B—Substances for Use Only as may be safely used as the food-contact Components of Paper and Paperboard surface of articles intended for use in producing, manufacturing, packing, Sec. processing, preparing, treating, pack- 176.110 Acrylamide-acrylic acid resins. 176.120 Alkyl ketene dimers. aging, transporting, or holding food, 176.130 Anti-offset substances. subject to the provisions of this sec- 176.150 Chelating agents used in the manu- tion; facture of paper and paperboard. (a) The coating is applied to a metal 176.160 Chromium (Cr III) complex of N- surface, cured, and washed with water ethyl-N-heptadecylfluoro-octane sulfonyl to remove soluble substances. glycine. (b) The coatings are formulated from 176.170 Components of paper and paperboard in contact with aqueous and fatty foods. optional substances which include: 176.180 Components of paper and paperboard (1) Substances generally recognized in contact with dry food. as safe. 176.200 Defoaming agents used in coatings. (2) Substances for which safe condi- 176.210 Defoaming agents used in the manu- tions of use have been prescribed in facture of paper and paperboard. § 175.300. 176.230 3,5-Dimethyl-1,3,5,2H- (3) Substances identified in para- tetrahydrothiadiazine-2-thione. graph (c) of this section, subject to the 176.250 Poly-1,4,7,10,13-pentaaza-15- hydroxyhexadecane. limitations prescribed. 176.260 Pulp from reclaimed fiber. (c) The optional substances per- 176.300 Slimicides. mitted are as follows: 176.320 Sodium nitrate-urea complex. 176.350 Tamarind seed kernel powder. List of substances Limitations AUTHORITY: 21 U.S.C. 321, 342, 346, 348, 379e. Ethylene glycol ...... As a solvent removed by water washing. SOURCE: 42 FR 14554, Mar. 15, 1977, unless Iron oxide. otherwise noted. Lithium hydroxide ...... Removed by water washing. EDITORIAL NOTE: Nomenclature changes to Methyl orange ...... As an acid-base indicator. Potassium dichromate ...... Removed by water washing. part 176 appear at 61 FR 14482, Apr. 2, 1996, Silica gel. and 66 FR 56035, Nov. 6, 2001. Sodium silicate. Zinc, as particulate metal. Subpart A [Reserved] (d) The coating in the finished form in which it is to contact food, when ex- Subpart B—Substances for Use tracted with the solvent or solvents Only as Components of Paper characterizing the type of food, and and Paperboard under the conditions of its intended use as shown in table 1 and 2 of § 175.300(d) § 176.110 Acrylamide-acrylic acid res- (using 20 percent alcohol as the solvent ins. when the type of food contains approxi- Acrylamide-acrylic acid resins may mately 20 percent alcohol) shall yield be safely used as components of arti- total extractives not to exceed those cles intended for use in producing, prescribed in § 175.300(c)(3); lithium ex- manufacturing, packing, processing,

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preparing, treating, packaging, trans- (b) Anti-offset powders are prepared porting, or holding food, subject to the from substances that are generally rec- provisions of this section. ognized as safe in food, substances for (a) Acrylamide-acrylic acid resins are which prior sanctions or approvals produced by the polymerization of ac- were granted and which are used in acrylamide with partial hydrolysis or by cordance with the specific provisions of the copolymerization of acrylamide such sanction or approval, and sub- and acrylic acid. stances named in paragraph (c) of this (b) The acrylamide-acrylic acid res- section. ins contain less than 0.2 percent resid- (c) The substances permitted are as ual monomer. follows: (c) The resins are used as adjuvants Substances Limitations in the manufacture of paper and paperboard in amounts not to exceed that Carbon tetrachloride. Methyl hydrogen necessary to accomplish the technical polysiloxanes. effect and not to exceed 2 percent by Industrial starch—modified .... Complying with § 178.3520 of weight of the paper or paperboard. this chapter. Stannous oleate. Zinc-2-ethyl hexoate. § 176.120 Alkyl ketene dimers. Alkyl ketene dimers may be safely § 176.150 Chelating agents used in the used as a component of articles in- manufacture of paper and paper- tended for use in producing, manufac- board. turing, packing, processing, preparing, The substances named in paragraph treating, packaging, transporting, or (a) of this section may be safely used in holding food, subject to the provisions the manufacture of paper and paper- of this section. board, in accordance with the condi- (a) The alkyl ketene dimers are man- tions prescribed in paragraphs (b) and ufactured by the dehydrohalogenation (c) of this section: of the acyl halides derived from the (a) Chelating agents: fatty acids of animal or vegetable fats and oils. List of substances Limitations (b) The alkyl ketene dimers are used Ammonium fructoheptonate. as an adjuvant in the manufacture of Ammonium glucoheptonate. Disodium ethylenediamine tetraacetate. paper and paperboard under such condi- Pentasodium salt of diethylenetriamine tions that the alkyl ketene dimers and pentaacetate. their hydrolysis products dialkyl Sodium fructoheptonate. ketones do not exceed 0.4 percent by Sodium glucoheptonate. Tetrasodium ethylenediamine tetra- weight of the paper or paperboard. acetate. (c) The alkyl ketene dimers may be Trisodium N-hydroxyethyl ethylene- used in the form of an aqueous emul- diamine triacetate. sion which may contain sodium (b) Any one or any combination of lignosulfonate as a dispersant. the substances named is used or in- § 176.130 Anti-offset substances. tended for use as chelating agents. (c) The substances are added in an Substances named in paragraphs (b) amount not greater than that required and (c) of this section may be safely to accomplish the intended technical used to prevent the transfer of inks effect nor greater than any specific employed in printing and decorating limitation, where such is provided. paper and paperboard used for food packaging in accordance with the pro- § 176.160 Chromium (Cr III) complex visions of this section: of N-ethyl-N-heptadecylfluoro-oc- (a) The substances are applied to the tane sulfonyl glycine. nonfood contact, printed side of the The chromium (Cr III) complex of N- paper or paperboard in an amount not ethyl - N -heptadecylfluoro-octane greater than that required to accom- sulfonyl glycine containing up to 20 plish the technical effect nor greater percent by weight of the chromium (Cr than any specific limitations, where III) complex of heptadecylfluoro-octane such are provided. sulfonic acid may be safely used as a

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component of paper for packaging dry 1 in paragraph (c) of this section are food when used in accordance with the subject to the provisions of § 176.180. following prescribed conditions. (a) Substances identified in para- (a) The food additive is used as a graph (a) (1) through (5) of this section component of paper in an amount not may be used as components of the food- to exceed 0.5 percent by weight of the contact surface of paper and paper- paper. board. Paper and paperboard products (b)(1) The food-contact surface of the shall be exempted from compliance paper is overcoated with a polymeric or with the extractives limitations prescribed in paragraph (c) of this section: resinous coating at least 1⁄3-mil in thickness, that meets the provision of Provided, That the components of the § 176.170; or food-contact surface consist entirely of one or more of the substances identi- (2) The treated paper forms one or fied in this paragraph: And provided fur- more plies of a paper in a multiwall ther, That if the paper or paperboard bag and is separated from the food by when extracted under the conditions at least one ply of packaging films or prescribed in paragraph (c) of this sec- grease-resistant papers which serves as tion exceeds the limitations on extrac- a functional barrier between the food tives contained in paragraph (c) of this additive and the food. Such packaging section, information shall be available films or grease-resistant papers con- from manufacturing records from form with appropriate food additive which it is possible to determine that regulations. only substances identified in this para- (c) The labeling of the food additive graph (a) are present in the food-con- shall contain adequate directions for tact surface of such paper or paper- its use to insure compliance with the board. requirements of paragraphs (a) and (b) (1) Substances generally recognized of this section. as safe in food. (2) Substances generally recognized § 176.170 Components of paper and pa- as safe for their intended use in paper perboard in contact with aqueous and paperboard products used in food and fatty foods. packaging. Substances identified in this section (3) Substances used in accordance may be safely used as components of with a prior sanction or approval. the uncoated or coated food-contact (4) Substances that by regulation in surface of paper and paperboard in- parts 170 through 189 of this chapter tended for use in producing, manufac- may be safely used without extractives turing, packaging, processing, pre- limitations as components of the paring, treating, packing, transporting, uncoated or coated food-contact sur- or holding aqueous and fatty foods, face of paper and paperboard in contact subject to the provisions of this sec- with aqueous or fatty food, subject to tion. Components of paper and paper- the provisions of such regulation. board in contact with dry food of the (5) Substances identified in this para- type identified under Type VIII of table graph, as follows:

List of Substances Limitations

Acetyl peroxide ...... For use only as polymerization catalyst. Acrylamide-methacrylic acid-maleic anhydride copolymers con- For use only as a retention aid employed prior to the sheet- taining not more than 0.2 percent of residual acrylamide forming operation in the manufacture of paper and paper- monomer and having an average nitrogen content of 14.9 board in such an amount that the finished paper and paper- percent such that a 1 percent by weight aqueous solution board will contain the additive at a level not in excess of has a minimum viscosity of 600 centipoises at 75 °F, as de- 0.05 percent by weight of dry fibers in the finished paper and termined by LVG-series Brookfield viscometer (or equivalent) paperboard. using a No. 2 spindle at 30 r.p.m. Acrylamide-b-methacrylyloxyethyltrimethylammonium methyl For use only as a retention aid and flocculant employed prior sulfate copolymer resins containing not more than 10 molar to the sheet-forming operation in the manufacture of paper percent of b-methacrylyloxyethyltrimethylammonium methyl and paperboard. sulfate and containing less than 0.2% of residual acrylamide monomer. Acrylic acid, sodium salt copolymer with polyethyleneglycol allyl For use only in paper mill boilers. ether (CAS Reg. No. 86830–15–1).

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List of Substances Limitations

Acrylic acid copolymer with 2-acrylamido-2-methylpropane-sul- For use only as a scale inhibitor prior to the sheet-forming op- fonic acid (CAS Reg. No. 40623–75–4) and/or its ammo- eration in the manufacture of paper and paperboard and nium/alkali metal mixed salts. The copolymer is produced by used at a level not to exceed 1.0 kilogram (2.2 pounds) of poly-merization of acrylic acid and 2-acrylamido-2- copolymer per 907 kilograms (1 ton) of dry paper and paper- methylpropane-sulfonic acid in a weight ratio of 60/40, such board fibers. that a 28 percent by weight aqueous solution of the polymer has a viscosity of 75–150 centipoises at 25 °C as determined by LV-series Brookfield viscometer (or equivalent) using a No. 2 spindle at 60 r.p.m. Acrylonitrile polymer, reaction product with ethylenediamine For use only as a size promoter and retention aid at a level not sulfate having a nitrogen content of 22.5–25.0 percent (Kjel- to exceed 0.5 percent by weight of the dry paper and paper- dahl dry basis) and containing no more than 0.075 percent board. monomer as ethylenediamine. The finished resin in a 24 percent by weight aqueous solution has a viscosity of 1,000– 2,000 centipoises at 25 °C as determined by LVT-series Brookfield viscometer using a No. 4 spindle at 50 r.p.m. (or by other equivalent method). Acrylonitrile polymer with styrene, reaction product with ethyl- 1. For use only as a sizing material applied after the sheet- enediamine acetate, having a nitrogen content of 7.4–8.3 forming operation in the manufacture of paper and paper- percent (Kjeldahl dry basis) and containing no more than board in such amount that the paper and paperboard will 0.25 percent monomer as ethylenediamine. contain the additive at a level not in excess of 0.25 percent by weight of the dry paper and paperboard. 2. For use only as a sizing material applied prior to the sheet- forming operation in the manufacture of paper and paperboard in such amount that the paper and paperboard will contain the additive at a level not in excess of 1.0 percent by weight of the dry paper and paperboard. 1-Alkenyl olefins, containing not less than 72 percent of C30 For use only under the following conditions: and higher olefins. 1. In coatings for paper and paperboard with food of Types I, II, IV–B, and VII–B described in table 1 of paragraph (c) of this section under conditions of use E, F, and G described in table 2 of paragraph (c) of this section. 2. In coatings for paper and paperboard with food of Type VIII described in table I of paragraph (c) of this section under conditions of use A through H described in table 2 of paragraph (c) of this section. (2-Alkenyl) succinic anhydrides mixture, in which the alkenyl For use only as a sizing agent employed prior to the sheet- groups are derived from olefins which contain not less than forming operation in the manufacture of paper and paper- 95 percent of C15-C21 groups. board and limited to use at a level not to exceed 1 percent by weight of the finished dry paper and paperboard fibers. Alkyl(C12-C20)methacrylatemethacrylic acid copolymers (CAS For use only as stabilizers employed prior to the sheet–forming Reg. No. 27401–06–5). operation in the manufacture of paper and paperboard. tert-Alkyl(C8-C16)mercaptans ...... For use only as polymerization-control agent. Aluminum acetate. 2-Amino-2-methyl-1-propanol (CAS Reg. No. 124–68–5) ...... For use as a dispersant for pigment suspension at a level not to exceed 0.25 percent by weight of pigment. The suspension is used as a component of coatings for paper and paperboard under conditions of use described in paragraph (c) of this section, table 2, conditions of use E through G. Ammonium bis(N-ethyl-2-perfluoroalkylsulfonamido ethyl) For use only as an oil and water repellant at a level not to ex- phosphates, containing not more than 15% ammonium mono ceed 0.17 pound (0.09 pound of fluorine) per 1,000 square (N-ethyl-2-perfluoroalkylsulfonamido ethyl) phosphates, feet of treated paper or paperboard of a sheet basis weight where the alkyl group is more than 95% C8 and the salts of 100 pounds or less per 3,000 square feet of paper or pa- have a fluorine content of 50.2% to 52.8% as determined on perboard, and at a level not to exceed 0.5 pound (0.26 a solids basis. pound of fluorine) per 1,000 square feet of treated paper or paperboard having a sheet basis weight greater than 100 lb. per 3,000 square feet as determined by analysis for total fluorine in the treated paper or paperboard without correction for any fluorine that might be present in the untreated paper or paperboard, when such paper or paperboard is used as follows: 1. In contact, under conditions of use C, D, E, F, G, or H described in table 2 of paragraph (c) of this section, with nonalcoholic food. 2. In contact with bakery products of Type VII, VIII, and IX described in table I of paragraph (c) of this section under good manufacturing practices of commercial and institutional baking. Ammonium persulfate. Ammonium thiosulfate. Ammonium zirconium carbonate (CAS Reg. No. 32535–84–5) For use only as an insolubilizer for binders used in coatings for and its tartaric acid adduct. paper and paperboard, and limited to use at a level not to exceed 2.5 percent by weight of coating solids.

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Ammonium zirconium citrate (CAS Reg. No. 149564–62–5), For use as insolubilizers with protein binders in coatings for ammonium zirconium lactate-citrate (CAS Reg. No. 149564– paper and paperboard, at a level not to exceed 1.4 percent 64–7), ammonium zirconium lactate (CAS Reg. No. 149564– by weight of coating solids. 63–6). Anionic polyurethane, produced by reacting the preliminary For use only as a surface sizing agent at a level not to exceed adduct formed from the reaction of glyceryl monostearate 0.1 percent by weight of dry paper and paperboard. and 2,4-toluenediisocyanate with not more than 10 mole percent N-methyldiethanolamine and not less than 90 mole percent dimethylolpropionic acid. The final product is a 15 to 20 percent by weight aqueous solution, having a Brookfield viscosity of 25 to 100 centipoises at 24 °C (75 °F). 9,10–Anthraquinone (Chemical Abstracts Service Registry No. For use only as a pulping aid in the alkaline pulping of 84–65–1) which has a purity of not less than 98 percent. lignocellulosic material at levels not to exceed 0.1 percent by weight of the raw lignocellulosic material. Aromatic petroleum hydrocarbon resin, hydrogenated (CAS For use only as modifiers in wax polymer blend coatings for Reg. No. 88526–47–0), produced by the catalytic polym- paper and paperboard at a level not to exceed 50 weight- erization of aromatic substituted olefins from low boiling dis- percent of the coating solids under conditions of use E, F, tillates of cracked petroleum stocks with a boiling point no and G identified in table 2 of paragraph (c) of this section. greater than 220 °C (428 °F), and the subsequent catalytic reduction of the resulting aromatic petroleum hydrocarbon resin. The resin meets the following specifications: softening point 85 °C (185 °F) minimum, as determined by ASTM Method E 28–67 (Reapproved 1982), ‘‘Standard Test Meth- od for Softening Point by Ring-and-Ball Apparatus,’’ and aniline point 70 °C (158 °F) minimum, as determined by ASTM Method D 611–82, ‘‘Standard Test Methods for Aniline Point and Mixed Aniline Point of Petroleum Products and Hydro- carbon Solvents,’’ which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the American Society for Testing and Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC. Azo-bisisobutyronitrile ...... For use only as polymerization catalyst. 1,2-Benzisothiazolin-3-one (CAS Registry No. 2634–33–5) ...... For use only as a preservative in paper coating compositions and limited to use at a level not to exceed 0.01 mg/in2 (0.0016 mg/cm2) of the finished paper and paperboard. Benzoyl peroxide ...... Do. N,N-Bis(2-hydroxyethyl)alkyl (C12-C18)amide ...... For use only as an adjuvant to control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet forming operation. Bis(methoxymethyl)tetrakis-[(octadecyloxy)-methyl]melamine For use only under the following conditions: resins having a 5.8–6.5 percent nitrogen content (CAS Reg. 1. As a water repellant employed prior to the sheet-forming op- No. 68412–27–1). eration in the manufacture of paper and paperboard in such amount that the finished paper and paperboard will contain the additive at a level not in excess of 1.6 percent by weight of the finished dry paper and paperboard fibers. 2. The finished paper and paperboard will be used in contact with nonalcoholic foods only. 3. As a water repellant employed after the sheet-forming operation in the manufacture of paper and paperboard in such amount that the finished paper and paperboard will contain the additive at a level not to exceed 1.6 percent by weight of the finished dry paper and paperboard fibers. The finished paper and paperboard will be used only in contact with food of Types I, II, IV–B, VI, VII–B, and VIII described in table 1 of paragraph (c) of this section. 2-Bromo-2-nitro-1,3-propanediol (CAS Reg. No. 52–51–7) ...... For use only as an antimicrobial/preservative in fillers, pigment slurries, starch sizing solutions, and latex coatings at levels not to exceed 0.01 percent by weight of those components. Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium For use as a surface active agent in package coating inks at salt (also known as butanedioic acid, sulfo-1,4-diisodecyl levels not to exceed 3 percent by weight of the coating ink. ester, ammonium salt [CAS Reg. No. 144093–88–9]).. tert-Butyl hydroperoxide ...... For use only as polymerization catalyst. tert-Butyl peroxide ...... Do. Calcium isostearate ...... For use only with n-decyl alcohol as a stabilizing material for aqueous calcium stearate dispersions intended for use as components of coatings for paper and paperboard. Carrageenan and salts of carrageenan as described in §§ 172.620 and 172.626 of this chapter. Castor oil, hydrogenated. Castor oil, sulfated, ammonium, potassium, or sodium salt. Cellulose, regenerated. Chloracetamide ...... For use only as polymerization-control agent.

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Cobaltous acetate ...... For use only as polymerization catalyst. Cumene hydroperoxide ...... Do. Cyanoguanidine ...... For use only: 1. As a modifier for amino resins. 2. As a fluidizing agent in starch and protein coatings for paper and paperboard. n-Decyl alcohol ...... For use only with calcium isostearate as a stabilizing material for aqueous calcium stearate dispersions intended for use as components of coatings for paper and paperboard. Dialdehyde guar gum ...... For use only as a wet-strength agent employed prior to the sheet-forming operation in the manufacture of paper and paperboard and used at a level not to exceed 1% by weight of the finished dry paper and paperboard fibers. Dialdehyde locust bean gum ...... Do.

Dialkyl(C16-C18)carbamoyl chloride (CAS Reg. No. 41319–54– For use as a sizing agent at a level not to exceed 0.2 percent 4) manufactured by the reaction of secondary amines de- by weight of the dry fiber. rived from fatty acids of animal or vegetable sources with phosgene. Diallyldimethyl ammonium chloride polymer with acrylamide For use only as a retention and/or drainage aid employed prior and potassium acrylate, produced by copolymerizing either to the sheet-forming operations in the manufacture of paper (1) diallyldimethyl ammonium chloride and acrylamide in a and paperboard and limited to use at a level not to exceed weight ratio of 50/50, with 4.4 percent of the acrylamide sub- 0.05 percent by weight of the finished paper and paper- sequently hydrolyzed to potassium acrylate or (2) polym- board. erized diallyldimethyl ammonium chloride, acrylamide and potassium acrylate (as acrylic acid) in a weight ratio of 50/ 47.8/2.2, respectively, so that the finished resin in a 1 percent by weight aqueous solution (active polymer) has a viscosity of more than 22 centipoises at 22 °C (72 °F) as determined by LVF series, Brookfield Viscometer using No. 1 spindle at 60 RPM (or by other equivalent method) (CAS Reg. No. 25136–75–8). Diallyldimethylammonium chloride with acrylamide (CAS Reg. For use only as a drainage and/or retention aid employed prior No. 26590–05–6). The copolymer is produced by copolym- to the sheet-forming operation in the manufacture of paper erizing diallyldimethylammonium chloride with acrylamide in and paperboard and limited to use at a level not to exceed a weight ratio of 50–50 so that the finished resin in a 1 per- 0.05 percent by weight of the finished paper and paper- cent by weight aqueous solution (active polymer) has a vis- board. cosity of more than 22 centipoises at 22 °C (71.6 °F), as determined by LVF-series Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or by other equivalent method). Diallyldiethylammonium chloride polymer with acrylamide, and diallyldimethylammonium chloride, produced by copolymerizing acrylamide, diallyldiethylammonium chloride, and diallyldimethylammonium chloride, respectively, in the following weight ratios and having viscosities determined at 22 °C, by LVF-series Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or by other equivalent method), as follows:. 1. Weight ratio: 50–2.5–47.5. The finished resin in a 1 per- For use only as a retention aid employed prior to the sheet- cent by weight aqueous solution has a minimum vis- forming operation in the manufacture of paper and paper- cosity of 22 centipoises. board and limited to use at a level not to exceed 0.05 percent by weight of the finished paper and paperboard. 2. Weight ratio: 25–2.5–72.5. The finished resin in a 0.20 For use only as a drainage and/or retention aid employed prior percent by weight aqueous solution has a minimum vis- to the sheet-forming operation in the manufacture of paper cosity of 20 centipoises. and paperboard and limited to use at a level not to exceed 0.075 percent by weight of the finished paper and paperboard. 3. Weight ratio: 80–2.5–17.5. The finished resin in a 0.30 For use only as a drainage and/or retention aid employed prior percent by weight aqueous solution has a minimum vis- to the sheet-forming operation in the manufacture of paper cosity of 50 centipoises. and paperboard and limited to use at a level not to exceed 0.075 percent by weight of the finished paper and paperboard.

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Diallyldiethylammonium chloride polymer with acrylamide, po- For use only as a retention aid employed prior to the sheet- tassium acrylate, and diallyldimethylammonium chloride. The forming operation in the manufacture of paper and paper- polymer is produced by copolymerizing either: (1) acryl- board and limited to use at a level not to exceed 0.05 per- amide, diallyldiethylammonium chloride, and cent by weight of the finished paper and paperboard. diallyldimethylammonium chloride in a weight ratio of 50– 2.5–47.5, respectively, with 4.4 percent of the acrylamide subsequently hydrolyzed to potassium acrylate, or (2) acrylamide, potassium acrylate (as acrylic acid), diallyldiethylammonium chloride, and diallyldimethylammonium chloride in a weight ratio of 47.8– 2.2–2.5–47.5, so that the finished resin in a 1 percent by weight aqueous solution has a minimum viscosity of 22 centipoises at 22 °C, as determined by LVF-series Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or by other equivalent method). Diallyldimethylammonium chloride polymer with acrylamide, re- For use only as a dry and wet strength agent employed prior action product with glyoxal, produced by copolymerizing not to the sheet-forming operation in the manufacture of paper less than 90 weight percent of acrylamide and not more than and paperboard in such an amount that the finished paper 10 weight percent of diallyldimethylammonium chloride, and paperboard will contain the additive at a level not in ex- which is then cross-linked with not more than 30 weight per- cess of 2 percent by weight of the dry fibers in the finished cent of glyoxal, such that a 10 percent aqueous solution has paper and paperboard. a minimum viscosity of 25 centipoises at 25 °C as determined by Brookfield viscometer Model RVF, using a No. 1 spindle at 100 r.p.m. 2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No.10222–01–2). For use as a preservative at a level not to exceed 100 parts per million in coating formulations and in component slurries and emulsions, used in the production of paper and paperboard and coatings for paper and paperboard. 2,5-Di-tert-butyl hydroquinone ...... For use only as an antioxidant for fatty based coating adjuvants provided it is used at a level not to exceed 0.005% by weight of coating solids. Diethanolamine ...... For use only: 1. As an adjuvant to control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet-forming operation. 2.In paper mill boilers. Diethanolamine salts of mono- and bis (1H,1H,2H,2H-perfluo- For use only as an oil and water repellant at a level not to ex- roalkyl) phosphates where the alkyl group is even-numbered ceed 0.17 pound (0.09 pound of fluorine) per 1,000 square in the range C8-C18 and the salts have a fluorine content of feet of treated paper or paperboard, as determined by anal- 52.4% to 54.4% as determined on a solids basis. ysis for total fluorine in the treated paper or paperboard without correction for any fluorine which might be present in the untreated paper or paperboard, when such paper or paperboard is used in contact with nonalcoholic foods under the conditions of use described in paragraph (c) of this section, table 2, conditions of use (B) through (H). Diethyl(2-hydroxyethyl) methylammonium methyl sulfate, acry- For use only as a retention aid and drainage aid employed late, polymer with acrylamide, chemical abstract service reg- prior to the sheet-forming operation in the manufacture of istry No. [26796–75–8] having 90–95 mole pct. acrylamide, a paper and paperboard at a level not to exceed 0.15 pct. by nitrogen content of not more than 19.7 pct. (Kjeldahl, dry weight of finished dry paper and paperboard fibers. basis), and a residual acrylamide monomer content of not more than 0.1 pct. The finished polymer in a 1 pct. by weight aqueous solution has a minimum viscosity of 900 centipoises at 25 °C as determined by LVT-series Brookfield viscometer using a No. 2 spindle at 12 r.p.m. (or by equivalent method). Diethylenetriamine ...... For use only as a modifier for amino resins. N,N-Diisopropanolamide of tallow fatty acids ...... For use only as an adjuvant to control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet-forming operation. Dimethylamine-epichlorohydrin copolymer in which not more For use only: than 5 mole-percent of dimethylamine may be replaced by 1. As a retention aid employed before the sheet-forming oper- an equimolar amount of ethylenediamine and in which the ation in the manufacture of paper and paperboard and lim- ratio of total amine to epichlorohydrin does not exceed 1:1. ited to use at a level not to exceed 1 percent by weight of The nitrogen content of the copolymer shall be 9.4 to 10.8 the finished paper and paperboard. weight percent on a dry basis and a 10 percent by weight 2. At the size press at a level not to exceed 0.017 percent by aqueous solution of the final product has a minimum vis- weight of the finished paper and paperboard. cosity of 5.0 centipoises at 25 °C, as determined by LVT-series Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or by other equivalent method). N-[(Dimethylamino)methyl]-acrylamide polymer with acrylamide For use only as a dry-strength agent employed prior to the and styrene having a nitrogen content of not more than 16.9 sheet-forming operation in the manufacture of paper and pa- percent and a residual acrylamide monomer content of not perboard and used at a level not to exceed 1 percent by more than 0.2 percent on a dry basis. weight of finished dry paper or paperboard fibers. N,N′-Dioleoylethylenediamine.

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Diphenylamine ...... For use only as an antioxidant for fatty based coating adjuvants provided it is used at a level not to exceed 0.005% by weight of coating solids. Dipropylene glycol. Disodium salt of 1,4-dihydro-9,10-dihydroxyanthracene (CAS For use only as a catalyst in the alkaline pulping of Reg. No. 73347–80–5). lignocellulosic materials at levels not to exceed 0.1 percent by weight of the raw lignocellulosic materials. N,N′-Distearoylethylenediamine. n-Dodecylguanidine acetate ...... For use only as an antimicrobial agent in paper and paperboard under the following conditions:

1. For contact only with nonalcoholic food having a pH above 5 and provided it is used at a level not to exceed 0.4 percent by weight of the paper and paperboard. 2. For use in the outer ply of multiwall paper bags for contact with dry food of Type VIII described in table I of paragraph (c) of this section and provided it is used at a level of 0.8 percent by weight of the paper. n-Dodecylguanidine hydrochloride ...... For use only as an antimicrobial agent in paper and paperboard under the following conditions: 1. For contact only with nonalcoholic food having a pH above 5 and provided it is used at a level not to exceed 0.4 percent by weight of the paper and paperboard. 2. For use in the outer ply of multiwall paper bags for contact with dry food of Type VIII described in table I of paragraph (c) of this section and provided it is used at a level of 0.8 percent by weight of the paper. Fatty acids derived from animal and vegetable fats and oils and salts of such acids, single or mixed, as follows: Aluminum. Ammonium. Calcium. Magnesium. Potassium. Sodium. Zinc. Ferric chloride. Ferrous ammonium sulfate. Fish oil, hydrogenated. Fish oil, hydrogenated, potassium salt. Furcelleran and salts of furcelleran as described in §§ 172.655 and 172.660 of this chapter. Glutaraldehyde (CAS Reg. No. 111–30–8) ...... For use only as an antimicrobial agent in pigment and filler slurries used in the manufacture of paper and paperboard at levels not to exceed 300 parts per million by weight of the slurry solids. Glyceryl lactostearate. Glyceryl mono-1,2-hydroxystearate. Glyceryl monoricinoleate. Guar gum modified by treatment with b-diethylaminoethyl For use only as a retention aid and/or drainage aid employed chloride hydrochloride. prior to the sheet-forming operation in the manufacture of paper and paperboard. Guar gum modified by treatment with not more than 25 weight For use only as a retention aid and/or internal size employed percent of 2,3-epoxypropyltri-methylammonium chloride such prior to the sheet-forming operation in the manufacture of that the finished product has a maximum chlorine content of paper and paperboard, and limited to use at a level: (1) Not 4.5 percent, a maximum nitrogen content of 3.0 percent, and to exceed 0.15 percent by weight of the finished dry paper a minimum viscosity in 1-percent-by-weight aqueous solution and paperboard fibers intended for use in contact with all of 1,000 centipoises at 77 °F, as determined by RV-series types of foods, except (2) not to exceed 0.30 pct. by weight Brookfield viscometer (or equivalent) using a No. 3 spindle at of the finished dried paper and paperboard fibers for use 20 r.p.m. with nonalcoholic and nonfatty food of types identified under Types I, II, IV–B, VI–B, VII–B, and VIII of table I in par. (c) of this section. N, N, N′,N′,N″,N″-Hexakis (methoxymethyl)-1,3,5-triazine-2,4,6- For use only as a water-repellent applied to the surface of triamine polymer with stearyl alcohol, a-octadecenyl-omega- paper and paperboard at levels not to exceed 1 percent by hydroxypoly(oxy-1,2-ethanediyl), and alkyl (C20+) alcohols weight of the finished dry paperboard fibers. The finished (CAS Reg. No. 130328–24–4). paper and paperboard will be used in contact with aqueous foods under conditions of use B through G as described in table 2 of paragraph (c) of this section. Hexamethylenetetramine ...... For use only as polymerization cross-linking agent for protein, including casein. Hydroquinone and the monomethyl or monoethyl ethers of hy- For use only as an inhibitor for monomers. droquinone.

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Hydroxymethyl-5,5-dimethylhydantoin (CAS Reg. No. 27636– For use only as a preservative in clay-type fillers at a level not 82–4), mixture with 1,3-bis(hydroxymethyl)-5,5- to exceed a combined total of 1,200 milligrams/kilograms dimethylhydantoin (CAS Reg. No. 6440–58–0). hydroxymethyl-5,5-dimethylhydantoin and 1,3- bis(hydroxymethyl)-5,5-dimethylhydantoin in the filler. Hydroxypropyl guar gum having a minimum viscosity of 5,000 For use only as a dry strength and formation aid agent em- centipoises at 25 °C., as determined by RV-series Brookfield ployed prior to the sheet-forming operation in the manufac- viscometer using a No. 4 spindle at 20 r.p.m. (or other suit- ture of paper and paperboard and used at a level not to ex- able method) and using a test sample prepared by dissolving ceed 1.5 percent by weight of finished dry paper or paper- 5 grams of moisture-free hydroxypropyl guar gum in 495 mil- board fibers. liliters of a 70 percent by weight aqueous propylene glycol solution. 12-Hydroxystearic acid-polyethylene glycol block copolymers For use only as a surfactant for dispersions of polyacrylamide (CAS Reg. No. 70142–34–6) produced by the reaction of retention and drainage aids employed prior to the sheet polyethylene glycol (minimum molecular weight 200) with 12- forming operation in the manufacture of paper and paper- hydroxystearic acid. board. Imidazolium compounds, 2–(C17 and C17-unsaturated alkyl)-1– For use only at a level not to exceed 0.5 percent by weight of [2–(C18 and C18-unsaturated amido)ethyl]-4,5-dihydro-1- the dry paper and paperboard. methyl, methyl sulfates (CAS Reg. No. 72749–55–4).. Isopropyl m- and p-cresols (thymol derived) ...... For use only as an antioxidant for fatty based coating adjuvants provided it is used as a level not to exceed 0.005% by weight of coating solids. Isopropyl peroxydicarbonate ...... For use only as polymerization catalyst. Japan wax. Lanolin. Lauryl peroxide ...... For use only as polymerization catalyst. Lauryl sulfate salts: Ammonium. Magnesium. Potassium. Sodium. Lecithin, hydroxylated. Lignin sulfonate and its calcium, potassium, and sodium salts. Maleic anhydride, polymer with ethyl acrylate and vinyl acetate, For use only as a deposit control additive prior to the sheet hydrolyzed (CAS Reg. No. 113221–69–5) and/or its ammo- forming operation to prevent scale buildup in the manufac- nium, potassium, and sodium salts. ture of paper and paperboard in contact with food, at a level not to exceed 0.075 percent (as the acid) by weight of the dry paper and paperboard. Methacrylic acid-acrylic acid copolymer (CAS Reg. No. 25751– For use only as a boiler water additive at a level not to exceed 21–7). 50 parts per million in the boiler water. N-methyldiallylamine hydrochloride polymer with For use only as a retention aid, flocculating agent, and wet- epichlorohydrin having a nitrogen content of 4.8 to 5.9 per- strength agent employed in the manufacture of paper and cent (Kjeldahl dry basis) such that a 20 percent by weight paperboard prior to the sheet-forming operation and limited aqueous solution has a minimum viscosity of 30 centipoises to use at a level not to exceed 1.5 percent by weight of the and maximum viscosity of 100 centipoises at 25 °C, as de- dry paper and paperboard. termined by LVF Model Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or equivalent method). Methyl naphthalene sulfonic acid-formaldehyde condensate, For use only as an adjuvant to control pulp absorbency and sodium salt. pitch content in the manufacture of paper and paperboard prior to the sheet-forming operation. N-methyl-N-(tall oil acyl) taurine, sodium salt (CAS Reg. No. For use only to control scale formation in the manufacture of 61791–41–1). paper and paperboard prior to the sheetforming operation at a level not to exceed 0.015 percent by weight of the dry paper and paperboard. Mineral oil, white. Mono-, di-, tri-(1-methyl-1-phenylethyl)-phenol, ethoxylated, For use only as an emulsifier for rosin based sizing at a level sulfated, ammonium salt with an average of 12 to 16 moles not to exceed 0.03 percent by weight of the finished dry of ethylene oxide (CAS Reg. No. 68130–71–2). paper and paperboard. Monoglyceride citrate. Monoisopropanolamine (CAS Reg. No. 78–96–6) ...... For use as a dispersant for titanium dioxide suspensions at a level not to exceed 0.68 percent by weight of titanium dioxide. The finished paper and paperboard will be used in contact with all food types under conditions of use E through G described in table 2 of paragraph (c) of this section. Mustardseed oil, sulfated, ammonium, potassium, or sodium salt. Naphthalene sulfonic acid-formaldehyde condensate, sodium For use only as an adjuvant to control pulp absorbency and salt. pitch content in the manufacture of paper and paperboard prior to the sheet-forming operation. Nitrocellulose, 10.9–12.2% nitrogen. Oleic acid, sulfated, ammonium, potassium, or sodium salt. N-Oleoyl-N′-stearoylethylenediamine. Oxystearin. Paraformaldehyde ...... For use only as setting agent for protein.

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Pentanoic acid, 4,4–bis [(gamma-omega-perfluoro-C8–20- For use only as an oil and water repellent and used at a level alkyl)thio] derivatives, compounds with diethanolamine (CAS not to exceed 8 pounds per ton of the finished paper or pa- Reg. No. 71608–61–2). perboard when such paper or paperboard is used in contact with nonalcoholic foods under conditions of use E through H described in table 2 of paragraph (c) of this section. Perfluoroalkyl acrylate copolymer (CAS Reg. No. 92265–81–1) For use only as an oil and water repellent at a level not to ex- containing 35 to 40 weight percent fluorine, produced by the ceed 0.5 percent by weight of the finished paper and paper- copolymerization of ethanaminium, N,N,N-trimethyl-2-[(2- board in contact with nonalcoholic foods under conditions of methyl-1-oxo-2-propenyl)-oxy]-, chloride; 2-propenoic acid, 2- use C, D, E, F, G, or H described in table 2 of paragraph (c) methyl-, oxiranylmethyl ester; 2-propenoic acid, 2-ethoxyethyl of this section. ester; and 2-propenoic acid, 2[[(heptadecafluoro- octyl)sulfonyl] methyl amino]ethyl ester. Perfluoroalkyl substituted phosphate ester acids, ammonium For use only as an oil and water repellant at a level not to ex- salts formed by the reaction of 2,2-bis[ (g,w-perfluoroC4-20 ceed 0.44 percent perfluoroalkyl actives by weight of the fin- alkylthio) methyl]-1,3-propanediol, polyphosphoric acid and ished paper and paperboard in contact with non-alcoholic ammonium hydroxide. foods under condition of use H as described in table 2 of paragraph (c) of this section; and in contact with food of types III, IV–A, V, VII–A, and IX described in table 1 of paragraph (c) of this section under conditions of use C through G as described in table 2 of paragraph (c) of this section.. Petrolatum ...... Complying with § 178.3700 of this chapter. Petroleum asphalt, steam and vacuum refined to meet the fol- For use only as a component of internal sizing of paper and lowing specifications: Softening point 88° C to 93° C, as de- paperboard intended for use in contact only with raw fruits, termined by ASTM method D36–76, ‘‘Standard Test Method raw vegetables, and dry food of the type identified under for Softening Point of Bitumen (Ring-and-Ball Apparatus);’’ Type VIII of table 1 in paragraph (c) of this section, and pro- penetration at 25° C not to exceed 0.3 mm, as determined by vided that the asphalt is used at a level not to exceed 5% by ASTM method D5–73 (Reapproved 1978), ‘‘Standard Test weight of the finished dry paper and paperboard fibers. Method for Penetration of Bituminous Materials,’’ which are incorporated by reference (copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408); and maximum weight loss not to exceed 3% when distilled to 371° C, nor to exceed an additional 1.1% when further distilled between 371° C and thermal decomposition. Petroleum wax, synthetic ...... Complying with § 178.3720 of this chapter. Phenothiazine ...... For use only as antioxidant in dry rosin size. Phenyl acid phosphate ...... For use only as polymerization catalyst in melamine-formaldehyde modified alkyd coatings and limited to use at a level not to exceed 2% by weight of the coating solids. Phenyl-b-naphthylamine ...... For use only as antioxidant in dry rosin size and limited to use at a level not to exceed 0.4% by weight of the dry rosin size. Phosphoric acid esters and polyesters (and their sodium salts) For use as an adjuvant prior to the sheet forming operation to of triethanolamine formed by the reaction of triethanolamine control pitch and scale formation in the manufacture of paper with polyphosphoric acid to produce a mixture of esters hav- and paperboard intended for use in contact with food only of ing an average nitrogen content of 1.5 percent and an aver- the types identified in paragraph (c) of this section, table 1, age phosphorus content of 32 percent (as PO4). under Types I, IV, V, VII, VIII, and IX, and used at a level not to exceed 0.075 percent by weight of dry paper or paperboard fibers. Poly[acrylamide-acrylic acid-N-(dimethyl-aminomethyl)acryl- For use only as a drainage aid and retention aid employed amide], produced by reacting 2.40 to 3.12 parts by weight of prior to the sheet-forming operation in the manufacture of polyacrylamide with 1.55 parts dimethylamine and 1 part paper and paperboard for use in contact with fatty foods formaldehyde, and containing no more than 0.2 percent under conditions of use described in paragraph (c) of this monomer as acrylamide. section, table 2, conditions of use E, F, and G. Poly(2-aminoethyl acrylate nitrate-co-2-hydroxypropyl acrylate) For use only as a retention and drainage aid employed prior to produced when one mole of hydroxypropyl acrylate and the sheet-forming operation in the manufacture of paper and three moles of acrylic acid are reacted with three moles of paperboard at a level not to exceed 0.2 percent by weight of ethylenimine and three moles of nitric acid, such that a 35 dry paper or paperboard fiber. percent by weight aqueous solution has a minimum viscosity of 150 centipoises at 72 °F., as determined by RVF-series Brookfield viscometer (or equivalent) using a No. 2 spindle at 20 r.p.m. Polyacrolein (1 part) -sodium bisulfite (0.7 part) adduct, con- For use only as an agent in modifying starches and starch taining excess bisulfite (ratio of excess bisulfite to adduct not gums used in the production of paper and paperboard and to exceed 1.5 to 1). limited to use at a level not to exceed 0.09 mg/in2 of the finished paper and paperboard.

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Poly[acrylamide-acrylic acid-N-(dimethylaminomethyl) acryl- For use only as a drainage aid, retention aid, or dry-strength amide] (C.A. Registry No. 53800–41–2), produced by react- agent employed prior to the sheet-forming operation in the ing 9.6–16.4 parts by weight of polyacrylamide with 1.6 parts manufacture of paper and paperboard at a level not to ex- dimethylamine and 1 part formaldehyde, and containing no ceed 0.25 percent by weight of finished dry paper and pa- more than 0.2% monomer as acrylamide, such that a 20% perboard fibers, when such paper or paperboard is used in aqueous solution has a minimum viscosity of 4,000 cP at 25 contact with fatty foods under conditions of use described in °C., as determined by Brookfield viscometer model RVT, paragraph (c) of this section, table 2, conditions of use E, F, using a No. 5 spindle at 20 r/min (or equivalent method). and G. Polyamide-epichlorohydrin modified resin produced by reacting For use only as a retention aid and flocculant employed prior adipic acid with diethylene triamine to produce a basic poly- to the sheet-forming operation in the manufacture of paper amide which is modified by reaction with formic acid and and paperboard and used at a level not to exceed 0.2 per- formaldehyde and further reacted with epichlorohydrin in the cent dry resin by weight of finished dry paper or paperboard presence of ammonium hydroxide to form a water-soluble fibers. cationic resin having a nitrogen content of 13–16 percent (Kjeldahl, dry basis) such that a 35 percent by weight aqueous solution has a minimum viscosity of 75 centipoises at 25 °C, as determined by Brookfield viscometer using a No. 1 spindle at 12 r.p.m. Polyamide-epichlorohydrin water-soluble thermosetting resins For use only under the following conditions: [CAS Reg. No. 68583–79–9] prepared by reacting adipic 1. As a retention aid employed prior to the sheet-forming oper- acid with diethylenetriamine to form a basic polyamide and ation in the manufacture of paper and paperboard and lim- further reacting the polyamide with an epichlorohydrin and ited to use at a level not to exceed 0.12 percent by weight of dimethylamine mixture such that the finished resins have a dry paper or paperboard. nitrogen content of 17.0 to 18.0 percent of a dry basis, and 2. The finished paper or paperboard will be used in contact that a 30-percent-by-weight aqueous solution has a minimum with food only of the types identified in paragraph (c) of this viscosity of 350 centipoises at 20 °C, as determined by a section, table 1, under types I and IV–B and under condi- Brookfield viscometer using a No. 3 spindle at 30 r.p.m. (or tions of use described in paragraph (c) of this section, table equivalent method). 2, conditions of use F and G. Polyamide-epichlorohydrin water-soluble thermosetting resin For use only as a wet strength agent and/or retention aid em- (CAS Reg. No. 96387–48–3) prepared by reacting N-methyl- ployed prior to the sheet-forming operation in the manufac- bis(3-aminopropyl) amine with oxalic acid and urea to form a ture of paper and paperboard and used at a level not to ex- basic polyamide and further reacting the polyamide with ceed 1.5 percent by weight of dry paper and paperboard fi- epichlorohydrin. bers. Polyamide-epichlorohydrin water-soluble thermosetting resins For use only in the manufacture of paper and paperboard prepared by reacting adipic acid, isophthalic acid, itaconic under conditions such that the resins do not exceed 1.5 peracid or dimethyl glutarate with diethylenetriamine to form a cent by weight of the paper or paperboard. basic polyamide and further reacting the polyamide with one of the following: Epichlorohydrin. Epichlorohydrin and ammonia mixture. Epichlorohydrin and sodium hydrosulfite mixture. Polyamidoamine-ethyleneimine-epichlorohydrin resin prepared For use only as a retention aid employed prior to the sheet- by reacting hexanedioic acid, N-(2-aminoethyl)-1,2- forming operation in the manufacture of paper and paper- ethanediamine, (chloromethyl)oxirane, ethyleneimine board at a level not to exceed 0.12 percent resin by weight (aziridine), and polyethylene glycol, partly neutralized with of the finished dry paper or paperboard. sulfuric acid (CAS Reg. No. 167678–45–7). Polyamidol-epichlorohydrin modified resin produced by reacting For use only as a wet strength agent employed prior to the glutaric acid dimethyl ester with diethylene-triamine to sheet-forming operation in the manufacture of paper and pa- produce a basic polyamide which is modified by reaction perboard, and used at a level not to exceed 2.5 percent by with formaldehyde and further reacted with epicholorohydrin weight of dry paper and paperboard fibers when such paper to form a water soluble cationic resin having a nitrogen con- or paperboard is used in contact with food under conditions tent of 10.9–11.9 percent and a chlorine content of 13.8– of use E through G described in table 2 of paragraph (c) of 14.8 percent, on a dry basis, and a minimum viscosity, in this section. 12.5 percent by weight aqueous solution, of 10 centipoises at 25 °C, as determined by a Brookfield Model LVF viscometer using a No. 1 spindle at 60 r.p.m. (or equivalent method). Polyamine-epichlorohydrin resin produced by the reaction of For use only as a flocculant, drainage aid, formation aid, reten- epichlorohydrin with monomethylamine to form a prepolymer tion aid, or strength additive employed prior to the sheet- and further reaction of this prepolymer with N,N,N′,N′- forming operation in the manufacture of paper and paper- tetramethylethylenediamine such that the finished resin hav- board, and used at a level not to exceed 0.12 percent by ing a nitrogen content of 11.6 to 14.8 percent and a chlorine weight of dry paper and paperboard fibers. content of 20.8 to 26.4 percent and a minimum viscosity, in 25 percent by weight aqueous solution, of 500 centipoises at 25 °C, as determined by LV-series Brookfield viscometer using a No. 2 spindle at 12 r.p.m. (or by other equivalent method).

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Polyamine-epichlorohydrin resin produced by the reaction of For use only as a clarifier in the treatment of influent water to N,N-dimethyl-1,3-propanediamine with epichlorohydrin and be used in the manufacture of paper and paperboard, and further reacted with sulfuric acid, Chemical Abstracts Service used at a level not to exceed 20 parts per million of the influ- Registry Number [27029–41–0], such that the finished resin ent water. has a maximum nitrogen content of 14.4 percent (dry basis) and a minimum viscosity in 30 percent by weight aqueous solution (pH 4–6) of 50 centipoises at 25 °C, as determined by Brookfield LVT model viscometer, using a No. 1 spindle at 12 r.p.m. (or equivalent method). Polyamine-epichlorohydrin water-soluble thermosetting resin For use only as a wetstrength agent and/or retention aid em- produced by reacting epichlorohydrin with: (i) polyamines ployed prior to the sheet-forming operation in the manufac- comprising at least 95 percent by weight C4 to C6 aliphatic ture of paper and paperboard, and used at a level not to ex- diamines and/or their self-condensation products, and/or (ii) ceed 1 percent by weight of dry paper and paperboard fi- prepolymers produced by reacting 1,2-dichloroethane with bers. the polyamines in (i). The finished resin has a nitrogen content of 5.0 to 9.0 percent, a chlorine content of 18.0 to 35.0 percent on a dry basis, and a minimum viscosity, in a 25 percent by weight aqueous solution, of 50 centipoises at 20 °C (68 °F), as determined by Brookfield HAT model viscometer using a No. 1H spindle at 50 r.p.m. (or equivlent method). Polyamine-epichlorohydrin water-soluble thermosetting resin For use only as a wet-strength agent and/or retention aid em- produced by reacting epichlorohydrin with: (i) polyamines ployed prior to the sheet-forming operation in the manufac- comprising at least 95 percent by weight C4 to C6 aliphatic ture of paper and paperboard, and used at a level not to ex- diamines and/or their seIf-condensation products and/or (ii) ceed 1 percent by weight of dry paper and paperboard fi- hexamethylenediamine, and/or (iii) bis(hexamethylene) tri- bers. amine and higher homologues, and/or (iv) prepolymers produced by reacting 1,2-dichloroethane with the polyamines in (i) and/or (ii) and/or (iii). The finished resin has a nitrogen content of 5.0 to 9.0 percent, a chlorine content of 18.0 to 35.0 percent on a dry basis, and a minimum viscosity, in a 25 percent by weight aqueous solution, of 50 centipoises at 20 °C (68 °F), as determined by Brookfield HAT model viscometer using a No. 1H spindle at 50 r.p.m. (or equivalent method). Polyamine-epichlorohydrin water soluble thermosetting resin For use only as a wet-strength agent and/or retention aid em- prepared by reacting hexamethylenediamine with 1,2-di- ployed prior to the sheet-forming operation in the manufac- chloroethane to form a prepolymer and further reacting this ture of paper and paperboard, and used at a level not to ex- prepolymer with epichlorohydrin. This resin is then reacted ceed 1 percent by weight of dry paper and paperboard fi- with nitrilotris (methylene-phosphonic acid), pentasodium bers. salt, such that the finished resin has a nitrogen content of 5.0–5.3 percent; a chlorine content of 29.7–31.3 percent; and a phosphorus content of 2.0–2.2 percent, on a dry basis, and a minimum viscosity, in 25 percent by weight aqueous solution, of 50 centipoises at 25 °C., as determined on a Brookfield HAT model viscometer using a No. 1H spindle at 50 r.p.m. (or equivalent method). Polyamine resin produced by the reaction of 1,2-dichloroethane For use only as a retention aid and/or flocculent employed with bis(hexamethylene)triamine and higher homologues prior to the sheet-forming operation in the manufacture of such that the finished resin has a nitrogen content of 13.0– paper and paperboard and used at a level not to exceed 0.1 15.0 percent on a dry basis, and a minimum viscosity in 25- percent by weight of dry paper or paperboard fibers. percent-by-weight aqueous solution of 75 centipoises at 25 °C., as determined by Brookfield HAT model viscometer using a No. 1 spindle at 50 r.p.m. (or equivalent method). Polyaminoamide-epichlorohydrin modified resin produced by For use only as a wet-strength agent and/or retention aid em- reacting adipic acid with diethylenetriamine to produce a pol- ployed prior to the sheet-forming operation in the manufac- yamide which is modified by reaction with ture of paper and paperboard, and used at a level not to ex- diethylaminopropylamine and further reacted with dichlor- ceed 0.5 percent by weight of the finished dry paper and pa- oethyl ether to form a polyamide intermediate. This poly- perboard. amide intermediate is then reacted with epichlorohydrin such that the finished resins have a nitrogen content of 10.9–12.4 percent (Kjeldahl, dry basis) and a minimum viscosity in 40 percent-by-weight aqueous solution of 250 centipoises at 22 °C, as determined by a Brookfield Model LVT viscometer using a No. 2 spindle at 30 r.p.m. (or equivalent method). Polybutene, hydrogenated; complying with the identity pre- For use only as provided in §§ 175.300, 178.3740 and scribed under § 178.3740(b) of this chapter. 178.3860 of this chapter.

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Poly(diallyldimethylammonium chloride) (CAS Reg. No. 26062– For use only: 79–3) produced by the polymerization of 1. As a pigment dispersant and/or retention aid prior to the (diallyldimethylammonium chloride) so that the finished resin sheet-forming operation in the manufacture of paper and pa- has a nitrogen content of 8.66±0.4 percent on a dry weight perboard, and used at a level not to exceed 10 pounds of basis and a minimum viscosity in a 40 percent by weight active polymer per ton of finished paper and paperboard. aqueous solution of 1,000 centipoises at 25 °C (77 °F), de- 2. As a pigment dispersant in coatings at a level not to exceed termined by LVF Model Brookfield Viscometer using a No. 3 3.5 pounds of active polymer per ton of finished paper and spindle at 30 r.p.m. (or equivalent method). The level of re- paperboard. sidual monomer is not to exceed 1 percent by weight of the polymer (dry basis). Poly (diallyldimethylammonium chloride) (CAS Reg. No. For use only as a flocculant employed prior to the sheet-form- 26062–79–3) produced by the polymerization of ing operation in the manufacture of paper and paperboard, diallyldimethylammonium chloride so that the finished resin and used at a level not to exceed 10 mg/L (10 parts per mil- has a nitrogen content of 8.66±0.4 percent on a dry basis lion) of influent water. and a minimum viscosity in a 15 weight-percent aqueous solution of 10 centipoises at 25 °C (77 °F), as determined by LVF Model Brookfield viscometer using a No. 1 spindle at 60 r/min (or equivalent method). The level of residual monomer is not to exceed 1 weight-percent of the polymer (dry basis). Poly(1,2-dimethyl-5-vinylpyridinium methyl sulfate) having a ni- For use only as an adjuvant employed in the manufacture of trogen content of 5.7 to 7.3 percent and a sulfur content of paper and paperboard prior to the sheet-forming operation. 11.7 to 13.3 percent by weight on a dry basis and having a minimum viscosity in 30-percent-by-weight aqueous solution of 2,000 centipoises at 25 °C., as determined by LV-series Brookfield viscometer (or equivalent) using a No. 4 spindle at 60 r.p.m. Polyester resin produced by reacting dimethylolpropionic acid For use only as a surface-sizing compound applied after the (CAS Registry No. 4767–03–7) as a comonomer, at no more sheet-forming operation in the manufacture of paper and pa- than 30 percent by weight of total polymer solids in reaction perboard and limited to use at levels not to exceed 0.1 per- with 2,2-dimethyl-1,3-propanediol, phthalic anhydride and cent by weight of finished dry paper or paperboard. isophthalic acid, such that the polyester resin has a viscosity of 200–600 centipoises at 80 °F as determined by a Brook- field RVT viscometer using a number 3 spindle at 50 rpm (or equivalent method). Polyethylene, oxidized; complying with the identity prescribed For use only as component of coatings that contact food only in § 177.1620(a) of this chapter. of the type identified under Type VII–B of table 1 in paragraph (c) of this section, and limited to use at a level not to exceed 50 percent by weight of the coating solids. Polyethyleneamine mixture produced when 1 mole of ethylene For use only as a retention aid employed prior to the sheet- dichloride, 1.05 moles of ammonia, and 2 moles of sodium forming operation in the manufacture of paper and paper- hydroxide are made to react so that a 10 percent aqueous board. solution has a minimum viscosity of 40 centipoises at 77 °F, as determined by Brookfield viscometer using a No. 1 spindle at 60 r.p.m. Polyethylene glycol (200) dilaurate ...... For use only as an adjuvant employed in the manufacture of paper and paperboard prior to the sheet-forming operation. Polyethylene glycol (400) dioleate. Polyethylene glycol (400) esters of coconut oil fatty acids. Polyethylene glycol (600) esters of tall oil fatty acids. Polyethylene glycol (400) monolaurate. Polyethylene glycol (600) monolaurate. Polyethylene glycol (400) monooleate. Polyethylene glycol (600) monooleate. Polyethylene glycol (400) monostearate. Polyethylene glycol (600) monostearate. Polyethylene glycol (3,000) monostearate. Polyethylenimine, produced by the polymerization of For use only as an adjuvant employed prior to sheet formation ethylenimine. in paper-making systems operated at a pH of 4.5 or higher, and limited to use at a level not to exceed 5% by weight of finished dry paper or paperboard fibers. Poly(isobutene)/maleic anhydride adduct, diethanolamine reac- For use only as a surfactant for dispersions of polyacrylamide tion product. The mole ratio of poly(isobutene)/maleic retention and drainage aids employed prior to the sheet for- anydride adduct to diethanolamine is 1:1. mation operation in the manufacture of paper and paperboard. Polymethacrylic acid, sodium salt, having a viscosity in 30-per- For use only as a coating adjuvant for controlling viscosity cent-by-weight aqueous solution of 125–325 centipoises at when used at a level not to exceed 0.3% by weight of coat- 25 °C as determined by LV-series Brookfield viscometer (or ing solids. equivalent) using a No. 2 spindle at 60 r.p.m. Polymethacrylic acid, sodium salt, having a viscosity in 40-per- For use only as a coating adjuvant for controlling viscosity cent-by-weight aqueous solution of 400–700 centipoises at when used at a level not to exceed 0.1% by weight of coat- 25 °C, as determined by LV-series Brookfield viscometer (or ing solids. equivalent) using a No. 2 spindle at 30 r.p.m.

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Poly[(methylimino)(2-hydroxytrimethylene)hydrochloride] pro- For use only as a retention aid employed prior to the sheet- duced by reaction of 1:1 molar ratio of methylamine and forming operation in such an amount that finished paper and epichlorohydrin so that a 31-percent aqueous solution at paperboard will contain the additive at a level not in excess 25° C has a Stokes viscosity range of 2.5-4.0 as determined of 1 percent by weight of the dry paper and paperboard. by ASTM method D1545–76 (Reapproved; 1981), ‘‘Standard Test Method for Viscosity of Transparent Liquids by Bubble Time Method,’’ which is incorporated by reference. Copies may be obtained from the American Society for Testing Ma- terials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Poly[oxyethylene (dimethyliminio) ethylene (dimethyliminio) For use only to improve dry-strength of paper and paperboard ethylene dichloride] produced by reacting equimolar quan- and as a retention and drainage aid employed prior to the tities of N,N,N,N-tetramethylethylene-diamine and sheet-forming operation in the manufacture of paper and pa- dichlorethyl ether to yield a solution of the solid polymer in perboard and limited to use at a level not to exceed 0.1 per- distilled water at 25° C with a reduced viscosity of not less cent by weight of the finished dry paper and paperboard fi- than 0.15 deciliter per gram as determined by ASTM method bers. D1243–79, ‘‘Standard Test Method for -Dilute Solution Vis- cosity of Vinyl Chloride Polymers,’’ which is incorporated by reference. Copies may be obtained from the American Soci- ety for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Wash- ington, DC 20408). The following formula is used for determining reduced viscosity:.

Reduced viscosity in terms of deciliters per gram=(t¥t0)/ (t¥C), where: t=Solution efflux time

to=Water efflux time C=Concentration of solution in terms of grams per deciliter Polypropylene glycol (minimum molecular weight 1,000). Potassium persulfate. 2-Propenoic acid, telomer with sodium 2-methyl-2-[(1-oxo-2- For use only as a deposit control additive employed prior to propenyl)amino]-1-propane sulfonate and sodium phos- the sheet forming operation in the manufacture of paper and phinate (CAS Reg. No. 110224–99–2). paperboard and at a level not to exceed 0.15 percent by weight of the dry paper and paperboard. Propylene glycol alginate. Protein hydrolysate from animal hides or soybean protein condensed with oleic and/or stearic acid. Rapeseed oil, sulfated ammonium, potassium, or sodium salt. Ricebran oil, sulfated ammonium, potassium, or sodium salt. Rosin and rosin derivatives ...... As provided in § 178.3870 of this chapter. Siloxanes (silicones), dimethyl, isopropyl methyl, methyl 1- For use only as a component of polyolefin coatings with methyl-C9-49-alkyl (CAS Reg. No. 144635–08–5). § 177.1520 of this chapter at a level not to exceed 3 percent by weight. The finished coating will be used only for paper and paperboard that contact food of types VI–A and VI–B of table 1 in paragraph (c) of this section, and under conditions of use C, D, and E, as described in table 2 in paragraph (c) of this section, with a maximum hot fill temperature of 200 °F (94 °C). Silver chloride-coated titanium dioxide ...... For use only as a preservative in polymer latex emulsions at a level not to exceed 2.2 parts per million (based on silver ion concentration) in the dry coating. Sodium carboxymethyl guar gum having a minimum viscosity For use only as a dry-strength and formation-aid agent em- of 2,700 centipoises at 25 °C after 24 hours as determined ployed prior to the sheet-forming operation in the manufac- by RV-series Brookfield viscometer (or equivalent) using a ture of paper and paperboard and used at a level not to ex- No. 4 spindle at 20 r.p.m. and using a test sample prepared ceed 1% by weight of finished dry paper or paperboard fi- by dissolving 8 grams of sodium carboxymethyl guar gum in bers. 392 milliliters of 0.2-percent-by-weight aqueous sodium o- phenylphenate solution. Sodium dioctyl sulfosuccinate. Sodium formaldehyde sulfoxylate ...... For use only as polymerization catalyst. Sodium hypochlorite. Sodium N-methyl-N-oleyltaurate ...... For use only as an adjuvant to control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet-forming operation.

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Sodium nitrite ...... For use only: 1. At levels not to exceed 0.2% by weight of lubricants or release agents applied at levels not to exceed 1 lb. per ton of finished paper or paperboard. 2. As an anticorrosion agent at levels not to exceed 0.2% by weight of wax emulsions used as internal sizing in the manufacture of paper and paperboard prior to the sheet-forming operation. Sodium persulfate. Sodium polyacrylate ...... For use only: 1. As a thickening agent for natural rubber latex coatings, provided it is used at a level not to exceed 2 percent by weight of coating solids. 2. As a pigment dispersant in coatings at a level not to exceed 0.25 percent by weight of pigment. Sodium poly(isopropenylphosphonate) (CAS Reg. No. 118632– For use only in paper mill boilers. 18–1). Sodium zinc potassium polyphosphate (CAS Reg. No. 65997– For use only as a pigment dispersant in coatings at a level not 17–3). to exceed 1 percent by weight of pigment. Sperm oil, sulfated, ammonium, potassium, or sodium salt. Stannous oleate. Stearyl-2-lactylic acid and its calcium salt. Styrene-butadiene copolymers produced by copolymerizing styrene-butadiene with one or more of the monomers: acrylamide, acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid, methacrylic acid, and N-methylolacrylamide (CAS Reg. No. 53504–31–7). The finished copolymers shall contain not more than 10 weight percent of total polymer units derived from acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid, and methacrylic acid, and shall contain not more than 3 weight percent of total polymer units derived from N-methylolacrylamide, and shall contain not more than 2 weight percent of polymer units derived from acrylamide.. Styrene-maleic anhydride copolymer, amidated, ammonium so- For use only as a surface size at a level not to exceed 1 per- dium salt; having, in a 25 percent by weight aqueous solu- cent by weight of paper or paperboard substrate. tion at pH 8.8, a minimum viscosity of 600 centipoises at 25 °C as determined by Brookfield model LVT viscometer using a No. 3 spindle at 60 r.p.m. (or equivalent method). Styrene-maleic anhydride copolymer, sodium salt (minimum For use only: molecular weight 30,000). 1. As a coating thickening agent at a level not to exceed 1% by weight of coating solids. 2. As surface size at a level not to exceed 1% by weight of paper or paperboard substrate. Styrene-methacrylic acid copolymer, potassium salt (minimum For use only as a coating thickening agent at a level not to ex- molecular weight 30,000). ceed 1% by weight of coating solids. Synthetic wax polymer prepared by the catalytic polymerization For use only as a component of petroleum wax and/or syn- of alpha olefins such that the polymer has a maximum iodine thetic petroleum wax complying with § 178.3710 or number of 18 and a minimum number average molecular § 178.3720 of this chapter at levels not to exceed 5 percent weight of 2,400. by weight of the wax: 1. Under conditions of use F and G described in table 2 of paragraph (c) of this section for all foods. 2. Under conditions of use E described in table 2 of paragraph (c) of this section for food Types I, II, IV–B, VI, VII–B and VIII as described in table 1 of paragraph (c) of this section. Tallow. Tallow alcohol. Tallow alcohol, hydrogenated. Tallow fatty acid, hydrogenated. Tallow hydrogenated. Tallow sulfated, ammonium, potassium, or sodium salt. Tetraethylenepentamine ...... For use only as a modifier for amino resins. 1,4,4a,9a-Tetrahydro-9, 10-anthracenedione (CAS Reg. No. For use only as a catalyst in the alkaline pulping of 56136–14–2). lignocellulosic materials at levels not to exceed 0.1 percent by weight of the raw lignocellulosic materials. N,N,N′, N′-Tetramethylethylenediamine polymer with bis-(2- For use only as a flocculent, drainage aid or retention aid em- chloroethyl) ether, first reacted with not more than 5 percent ployed prior to the sheet forming operation in the manufac- by weight 1-chloro-2,3-epoxypropane and then reacted with ture of paper and paperboard and limited to use at a level not more than 5 percent by weight poly (acrylic acid) such not to exceed 0.2 percent by weight of the finished dry paper that a 50 percent by weight aqueous solution of the product and paperboard fibers. has a nitrogen content of 4.7–4.9 percent and viscosity of 350–700 centipoises at 25 °C as determined by LV series Brookfield viscometer using a No. 2 spindle at 60 r.p.m. (or by other equivalent method).

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List of Substances Limitations

Tetrasodium N- (1,2-dicarboxyethyl) - N - octadecylsulfo–suc- For use only as an emulsifier in aqueous dispersions of rosin cinamate. sizes complying with § 178.3870(a)(4) of this chapter and limited to use prior to the sheet-forming operation in the manufacture of paper and paperboard at a level not to exceed 0.02 pct by weight of finished paper and paperboard. Triethanolamine ...... For use only to adjust pH during the manufacture of amino resins permitted for use as components of paper and paperboard. Triethylene glycol adipic acid monoester produced by reacting For use only as a curl-control agent at a level not to exceed equimolar quantities of triethylene glycol and adipic acid. 2% by weight of coated or uncoated paper and paperboard. Triethylenetetramine ...... For use only as a modifier for amino resins. 1,3,5-Triethylhexahydro-1,3,5-triazine (CAS Registry No. 7779– For use only as an antimicrobial agent for coating, binder, pig- 27–3). ment, filler, sizing, and similar formulations added prior to the heat drying step in the manufacture of paper and paperboard and limited to use at a level between 0.05 and 0.15 percent by weight of the formulation. Undecafluorocyclohexanemethanol ester mixture of dihydrogen For use only as an oil repellent at a level not to exceed 0.087 phosphate, compound with 2,2′ iminodiethanol (1:1); hydro- lb (0.046 lb of fluorine) per 1,000 ft2 of treated paper or pa- gen phosphate, compound with 2,2′-iminodiethanol (1:1); and perboard, as determined by analysis for total fluorine in the P,P′-dihydrogen pyrophosphate, compound with 2,2′- treated paper or paperboard without correction for any fluo- iminodiethanol (1:2); where the ester mixture has a fluorine rine which might be present in the untreated paper or paper- content of 48.3 pct to 53.1 pct as determined on a solids board, when such paper or paperboard is used in contact basis. with food only of the types identified in paragraph (c) of this section, table 1, under Types IVA, V, VIIA, VIII, and IX, and under the conditions of use B through G described in table 2 of paragraph (c) of this section. Viscose rayon fibers. Wax, petroleum ...... Complying with § 178.3710 of this chapter. Xanthan gum, conforming to the identity and specifications pre- For use only at a maximum level of 0.125 percent by weight of scribed in § 172.695 of this chapter, except that the residual finished paper as a suspension aid or stabilizer for aqueous isopropyl alcohol shall not exceed 6,000 parts per million. pigment slurries employed in the manufacture of paper and paperboard. Xylene sulfonic acid-formaldehyde condensate, sodium salt ..... For use only as an adjuvant to control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet-forming operation. Zeolite Na-A (CAS Reg. No. 68989–22–0) ...... For use as a pigment extender at levels not to exceed 5.4 percent by weight of the finished paper and paperboard. Zinc formaldehyde sulfoxylate ...... For use only as polymerization catalyst. Zinc octoate. Zirconium oxide ...... For use only as a component of waterproof coatings where the zirconium oxide is present at a level not to exceed 1 percent by weight of the dry paper or paperboard fiber and where the zirconium oxide is produced by hydrolysis of zirconium acetate.

(b) Substances identified in para- (1) Substances identified in graphs (b) (1) and (2) of this section § 175.300(b)(3) of this chapter with the may be used as components of the food- exception of those identified in para- contact surface of paper and paper- graphs (b)(3) (v), (xv), (xx), (xxvi), board, provided that the food-contact (xxxi), and (xxxii) of that section and surface of the paper or paperboard com- paragraph (a) of this section. plies with the extractives limitations (2) Substances identified in this para- prescribed in paragraph (c) of this sec- graph (b)(2) follow: tion.

List of substances Limitations

Acrylamide copolymerized with ethyl acrylate and/or stryene and/or methacrylic acid, subsequently reacted with formaldehyde and butyl alcohol. Acrylamide copolymerized with ethylene and vinyl chloride in For use only as coatings or components of coatings. such a manner that the finished copolymers have a minimum weight average molecular weight of 30,000 and contain not more than 3.5 weight percent of total polymer units derived from acrylamide, and in such a manner that the acrylamide portion may or may not be subsequently partially hydrolyzed. 2-Acrylamido-2-methyl-propanesulfonic acid, homopolymer, so- For use only in coatings at a level not to exceed 0.01 mg/in2 dium salt (CAS Reg. No. 35641–59–9). Acrylic and modified acrylic polymers ...... Complying with § 177.1010 of this chapter.

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List of substances Limitations

Acrylic copolymers produced by copolymerizing 2 or more of the acrylate monomers butyl acrylate, ethyl acrylate, ethyl methacrylate, methyl acrylate, methyl methacrylate, and n- propyl methacrylate, or produced by copolymerizing one or more of such acrylate monomers together with one or more of the monomers acrylic acid, acrylonitrile, butadiene, 2- ethyl-hexyl acrylate, fumaric acid, glycidyl methacrylate, n- hexyl-methacrylate, itaconic acid, methacrylic acid, styrene, vinyl acetate, vinyl chloride, and vinylidene chloride. The finished copolymers shall contain at least 50 weight percent of polymer units derived from one or more of the monomers butyl acrylate, ethyl acrylate, ethyl methacrylate, methyl acrylate, methyl methacrylate, and n-propyl methacrylate; and shall contain not more than 5 weight percent of total polymer units derived from acrylic acid, fumaric acid, glycidyl methacrylate, n-hexyl methacrylate, itaconic acid, and methacrylic acid. The provision limiting the finished acrylic copolymers to not more than 5 units derived from acrylic acid, fumaric acid, glycidyl methacrylate, n-hexyl methacrylate, itaconic acid, and methacrylic acid is not applicable to finished acrylic copolymers used as coating adjuvants at a level not exceeding 2 weight percent of total coating solids. Alkyl mono- and disulfonic acids, sodium salts (produced from For use only: n-alkanes in the range of C10-C18 with not less than 50 per- 1. As emulsifiers for vinylidene chloride copolymer coatings cent C14-C16).. and limited to use at levels not to exceed 2 percent by weight of the coating solids. 2. As emulsifiers for vinylidene chloride copolymer or homopolymer coatings at levels not to exceed a total of 2.6 percent by weight of coating solids. The finished polymer contacts food only of types identified in paragraph (c) of this section, table 1, under Types I, II, III, IV, V, VIA, VIB, VII, VIII, and IX and under conditions of use E, F, and G described in table 2 of paragraph (c) of this section. 2-Bromo-4′-hydroxyacetophenone ...... For use only as a preservative for coating formulations, binders, pigment slurries, and sizing solutions at a level not to exceed 0.006 percent by weight of the coating, solution, slurry or emulsion. Butylbenzyl phthalate ...... Complying with § 178.3740 of this chapter. Butyl oleate, sulfated, ammonium, potassium, or sodium salt. Butyraldehyde. Captan (N-trichloromethylmercapto-4-cyclohexene-1, 2- For use only as a mold- and mildew-proofing agent in coatings dicarboximide). intended for use in contact with food only of the types identified in paragraph (c) of this section, table 1, under Type I, II, VI–B, and VIII. Castor Oil, polyoxyethylated (42 moles ethylene oxide) ...... For use only as an emulsifier in nitrocellulose coatings for paper and paperboard intended for use in contact with food only of the types identified in paragraph (c) of this section, table 1, under Types IV A, V, VII A, VIII, and IX; and limited to use at a level not to exceed 8 percent by weight of the coating solids. 1-(3-Chloroallyl)-3,5,7-triaza-1- azoniaadamantane chloride For use only: (CAS Reg. No. 4080–31–3). 1. As a preservative at a level of 0.3 weight percent in latexes used as pigment binders in paper and paperboard intended for use in contact with nonacidic, nonalcoholic food and under the conditions of use described in paragraph (c) of this section, table 2, conditions of use E, F, and G. 2. As a preservative at a level not to exceed 0.07 weight percent in latexes and 0.05 weight percent in pigment slurries used as components of coatings for paper and paperboard intended for use in contact with food. 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172– For use only: 55–4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 1. As an antimicrobial agent for polymer latex emulsions in 2682–20–4) mixture at a ratio of 3 parts to 1 part, manufac- paper coatings at a level not to exceed 50 parts per mil- tured from methyl-3-mercaptopropionate (CAS Reg. No. lion (based on isothiazolone active ingredients) in the 2935–90–2). The mixture may contain magnesium nitrate coating formulation. (CAS Reg. No. 10377–60–3) at a concentration equivalent to 2. As an antimicrobial agent for finished coating formulations the isothiazolone active ingredients (weight/weight). and for additives used in the manufacture of paper and paperboard including fillers, binders, pigment slurries, and sizing solutions at a level not to exceed 25 parts per million (based on isothiazolone active ingredients) in the coating formulations and additives. Copper 8-quinolinolate ...... For use only as preservative for coating formulations.

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List of substances Limitations

Cyclized rubber produced when natural pale crepe rubber dis- For use only in coatings for paper and paperboard intended for solved in phenol is catalytically cyclized so that the finished use in contact with food only of the types identified in para- cyclized rubber has a melting point of 145 °C to 155 °C as graph (c) of this section, table 1, under Types VIII and IX. determined by ASTM method E28–67 (Reapproved 1982), ‘‘Standard Test Method for Softening Point by Ring-and-Ball Apparatus,’’ which is incorporated by reference (copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408), and contains no more than 4000 ppm of residual-free phenol as determined by a gas liquid chromatographic procedure titled ‘‘Determination of Free Phenol in Cyclized Rubber Resin,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65–7) .. For use only as a preservative at levels not more than 0.05 weight percent and not less than 0.01 weight percent: in latexes used as pigment binders in coatings; in pigment slurries used in coatings; and/or in coatings themselves. The total level of the preservative in the finished coating shall not exceed 0.04 weight percent of the finished coating solids. Dibutyl phthalate. Dibutyl sebacate.

Di(C7,C9-alkyl) adipate ...... Complying with § 178.3740 of this chapter. Dicyclohexyl phthalate. Diethylene glycol dibenzoate (CAS Reg. No. 120–55–8) ...... For use only as a plasticizer for polyvinyl acetate coatings at a level not to exceed 5 percent by weight of the coating solids under conditions described in paragraph (c) of this section, table 2, conditions of use E, F, and G. Diethylene glycol ester of the adduct of terpene and maleic anhydride. Dihydroxy dichlorodiphenyl methane ...... For use only as preservative for coating formulations. Dimethylpolysiloxane, 100 centistokes viscosity. Dimethylpolysiloxane-beta-phenylethyl methyl polysiloxane copolymer (2:1), 200 to 400 centistokes viscosity. N,N′-Diphenyl-p-phenylenediamine ...... For use only as polymerization inhibitor in 2-sulfoethyl methacrylate, sodium salt. Dipropylene glycol dibenzoate (CAS Reg. No. 27138–31–4) ..... 1. For use only as a plasticizer for polyvinyl acetate coatings at a level not to exceed 5 percent by weight of the coating solids under conditions described in paragraph (c) of this section, table 2, condition of use E. 2. For use only as a plasticizer for polyvinyl acetate coatings at a level not to exceed 10 percent by weight of the coating solids under conditions described in paragraph (c) of this section, table 2, conditions of use F and G. Disodium N-octadecylsulfosuccinamate ...... For use only as an emulsifier in resin latex coatings and limited to use at a level not to exceed 0.05% by weight of the coating solids. EDTA (ethylenediaminetetraacetic acid) and its sodium and/or calcium salts. Ethanedial, polymer with tetrahydro-4-hydroxy-5-methyl- For use only as an insolubilizer for starch-based coatings and 2(1H)pyrimidinone, propoxylated (CAS Reg. No. 118299-90- limited to use at a level not to exceed 5.0 percent by weight 4). of the coating. Ethylene-acrylic acid copolymers produced by the copolymerization of ethylene and acrylic acid and/or their partial ammonium salts. The finished copolymer shall contain no more than 25 weight percent of polymer units derived from acrylic acid and no more than 0.35 weight percent of residual monomeric acrylic acid, and have a melt index not to exceed 350 as determined by ASTM method D1238–82, ‘‘Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer,’’ which is incorporated by reference. Copies may be obtained from the American Society for Testing Ma- terials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Formaldehyde ...... For use only as preservative for coating formulations.

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List of substances Limitations

Glyoxal ...... For use only as an insolubilizing agent in starch- and protein- based coatings that contact nonalcoholic foods, and limited to use at a level not to exceed 6 percent by weight of the starch or protein fraction of the coating solids. Glyceryl monobutyl ricinoleate. Hydroxymethyl derivatives (mixture of mono and poly) of [N-(1, For use only as a comonomer in polyvinyl acetate latex coat- 1-dimethyl-3-oxobutyl) acrylamide] produced by reacting 1 ings and limited to use at a level not to exceed 1 percent by mole of the [N-(1,1-dimethyl-3-oxobutyl) acrylamide] with 3 weight of dry polymer solids. moles of formaldehyde such that the finished product has a maximum nitrogen content of 6.2 percent and a maximum hydroxyl content of 15 percent by weight on a dry basis. Isobutyl oleate, sulfated, ammonium, potassium, or sodium salt. Maleic anhydride adduct of butadiene-styrene copolymer. a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1a- methylstyrene to 3 vinyltoluene). Modified kaolin clay (CAS Reg. No. 1344–00–9) is produced For use only as a component of coatings in paper and paper- by the reaction of sodium silicate (CAS Reg. No. 1344–09– board products at a level not to exceed 9 percent by weight 8) and kaolinite clay (CAS Reg. No. 1332–58–7) under hy- of the coating intended for use in contact with food of Types drothermal conditions. The reaction product has a molecular I through IX described in table 1 of paragraph (c) of this sec- weight between 246 and 365 and consists of 46 to 55 per- tion under conditions of use C through H described in table cent silicon dioxide (Si02), 28 to 42 percent aluminum oxide 2 of paragraph (c) of this section. (A1203), and 2 to 7 percent of sodium oxide (Na20). The reaction product will not consist of more than 70 percent modified kaolin clay. Naphthalene sulfonic acid-formaldehyde condensate, sodium salt. Oleyl alcohol. Oxazolidinylethylmethacrylate (CAS Registry No. 46236–15–1) For use only as a binder for pigment coatings as a binder level copolymer with ethyl acrylate and methyl methacrylate, and not to exceed 4.0 percent by weight of dry paper or paper- containing not more than 6 percent by weight of board. oxazolidinylethylmethacrylate. Maximum nitrogen content shall be 0.5 percent and number average molecular weight of that portion of the copolymer soluble in tetrahydrofuran shall be not less than 50,000. Pentaerythritol tetrastearate. Petroleum alicyclic hydrocarbon resins, or the hydrogenated For use only as modifiers in waxpolymer blend coatings for product thereof, meeting the following specifications: Soft- corrugated paperboard intended for use in bulk packaging or ening point 97 °C minimum, as determined by ASTM method raw fruits, raw vegetables, iced meat, iced fish, and iced E28–67 (Reapproved 1982), ‘‘Standard Test Method for Soft- poultry; and limited to use at a level not to exceed 30 ening Point by Ring and Ball Apparatus;’’ aniline point 120 weight-percent of the coating solids. °C minimum, as determined by ASTM method D611–82, ‘‘Standard Test Methods for Aniline Point and Mixed Aniline Point of Petroleum Products and Hydrocarbon Solvents,’’ which are incorporated by reference (copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408). Specific gravity 0.96–0.99 (20 °C/20 °C). Such petroleum hydrocarbon resins are produced by the catalytic polymerization of dienes and olefins from low-boiling distillates of cracked petroleum stocks that contain no material boiling over 200 °C and that meet the ultraviolet absorbance limits prescribed in § 172.880(b) of this chapter when subjected to the analytical procedure described in § 172.886(b) of this chapter, modified as follows: Treat the product as in the first paragraph under ‘‘Procedure’’ in § 172.250(b)(3) of this chapter. Then proceed with § 172.886(b) of this chapter, starting with the paragraph commencing with ‘‘Promptly complete transfer of the sample * * *’’. Polyester resin formed by the reaction of the methyl ester of rosin, phthalic anhydride, maleic anhydride and ethylene glycol, such that the polyester resin has an acid number of 4 to 11, a drop-softening point of 70 °C–92 °C., and a color of K or paler. Polyester resin produced by reacting the acid groups in montan wax with ethylene glycol. Polyethylene, oxidized ...... Complying with § 177.1620 of this chapter. Polyethylene reacted with maleic anhydride such that the modified polyethylene has a saponification number not in excess of 6 after Soxhlet extraction for 24 hours with anhydrous ethyl alcohol. Polyoxyethylated (40 moles) tallow alcohol sulfate, sodium salt Not to exceed 300 p.p.m. in finished coated paper or paperboard.

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List of substances Limitations

Polyoxypropylene-polyoxyethylene block polymers (minimum molecular weight 6,800). Polyvinyl acetate. Polyvinyl alcohol (minimum viscosity of 4% aqueous solution at 20 °C. of 4 centipoises). Polyvinyl butyral. Polyvinyl formal. Polyvinylidene chloride. Polyvinyl pyrrolidone. Polyvinyl stearate. Propylene glycol mono- and diesters of fats and fatty acids. Siloxanes and silicones; platinum-catalyzed reaction product of For use only as a surface coating. Platinum content not to ex- vinyl-containing dimethyl polysiloxane (CAS Reg. Nos. ceed 200 parts per million. 68083–19–2 and 68083–18–1) with methyl hydrogen 1. In coatings for paper and paperboard provided the coating polysiloxane (CAS Reg. No. 63148–57–2) or dimethyl (meth- contacts food only of the types identified in paragraph (c) of yl hydrogen) polysiloxane (CAS Reg. No. 68037–59–2). this section, table 1, under Types I, II, VI, and VII–B when Diallyl maleate (CAS Reg No. 999–21–3), dimethyl maleate used under conditions of use E, F, and G described in table (CAS Reg. No. 624–48–6), 1-ethynyl-1-cyclohexanol (CAS 2 of paragraph (c) of this section. Reg. No. 78–27–3) and vinyl acetate (CAS Reg. No. 108– 2. In coatings for paper and paperboard provided the coating 05–4) may be used as optional polymerization inhibitors. contacts food only of the types identified in paragraph (c) of this section, table 1, under Types III, IV, V, VII–A, VIII, and IX when used under conditions of use A through H described in table 2 of paragraph (c) of this section. Siloxanes and silicones; platinum-catalyzed reaction product of Platinum content not to exceed 100 parts per million. For use vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a release coating for pressure sensitive adhesives. 68083–19–2 and 68083–18–1), with methyl hydrogen polysiloxane (CAS Reg. No. 63148–57–2). Dimethyl maleate (CAS Reg. No. 624–48–6), vinyl acetate (CAS Reg. No. 108–05–4), dibutyl maleate (CAS Reg. No. 105–76–0) and diallyl maleate (CAS Reg. No. 999–21–3) may be used as optional polymerization inhibitors. The polymer may also contain C16-C18 olefins (CAS Reg. No. 68855–60–7) as a control release agent. Sodium decylbenzenesulfonate. Sodium dihexyl sulfosuccinate. Sodium n-dodecylpolyethoxy (50 moles) sulfate-sodium For use only as an emulsifier in coatings that contact food only isododecylphenoxypolyethoxy (40 moles) sulfate mixtures. of the types identified in paragraph (c) of this section, table 1, under Types IV–A, V, VII, VIII, and IX; and limited to use at levels not to exceed 0.75 percent by weight of the coating solids. Sodium 2-ethylhexyl sulfate. Sodium oleoyl isopropanolamide sulfosuccinate. Sodium pentachlorophenate ...... For use only as preservative for coating formulations. Sodium o-phenylphenate ...... Do. Sodium vinyl sulfonate polymerized. Sodium xylenesulfonate (CAS Reg. No. 1300–72–7) ...... For use only in paper and paperboard coatings at levels not to exceed 0.01 percent by weight of the finished paper and paperboard. Styrene copolymers produced by copolymerizing styrene with For use only as a coating or component of coatings and limited maleic anhydride and its methyl and butyl (sec- or iso-) to use at a level not to exceed 1% by weight of paper or pa- esters. Such copolymers may contain b-nitrostyrene as a po- perboard substrate. lymerization chain terminator. Styrene polymers made by the polymerization of any combina- For use only in contact with foods of Types IV–A, V, and VII in tion of styrene or alpha methyl styrene with acrylic acid, table 1 of paragraph (c) of this section, under use conditions methacrylic acid, 2-ethyl hexyl acrylate, methyl methacrylate, E through G in table 2 of paragraph (c), and with foods of and butyl acrylate. The styrene and alpha methyl styrene, in- Types VIII and IX without use temperature restriction. dividually, may constitute from 0 to 80 weight percent of the polymer. The other monomers, individually, may be from 0 to 40 weight percent of the polymer. The polymer number average molecular weight (Mn) shall be at least 2,000 (as determined by gel permeation chromatography). The acid number of the polymer shall be less than 250. The monomer content shall be less than 0.5 percent. Styrene-acrylic copolymers (CAS Reg. No. 25950–40–7 pro- For use only as a component of coatings and limited to use at duced by polymerizing 77 to 83 parts by weight of styrene a level not to exceed 20 percent by weight of the coating with 13 to 17 parts of methyl methacrylate, 3 to 4 parts of solids. butyl methacrylate, 0.5 to 2.5 parts of methacrylic acid, and 0.1 to 0.3 part of butyl acrylate such that the finished copolymers have a minimum number average molecular weight greater than 100,000 and a level of residual styrene monomer in the polymer not to exceed 0.1 percent by weight.

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List of substances Limitations

Styrene-butadiene copolymers produced by copolymerizing styrene-butadiene with one or more of the monomer: acrylamide, acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid, and methacrylic acid. The finished copolymers shall contain not more than 10 weight percent of total polymer units derived from acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid and methacrylic acid, and shall contain not more than 2 weight percent of polymer units derived from acrylamide. Styrene-butadiene copolymers with 2-hydroxyethyl acrylate and acrylic acid containing not more than 15 weight percent acrylic acid and no more than 20 weight percent of a combination of 2-hydroxyethyl acrylate and acrylic acid. Styrene-butadiene-vinylidene chloride copolymers containing For use only as coatings or components of coatings. not more than 40 weight percent of vinylidene chloride in the finished copolymers. The finished copolymers may contain not more than 10 weight percent of total polymer units derived from acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid, and/or methacrylic acid. Styrene-dimethylstyrene-a-methylstyrene copolymers produced For use only in coatings for paper and paperboard intended for by polymerizing equimolar ratios of the three comonomers use in contact with nonfatty food and limited to use at a level such that the finished copolymers have a minimum average not to exceed 50% by weight of the coating solids. molecular weight of 835 as determined by ASTM method D2503–82, ‘‘Standard Test Method for Molecular Weight (Relative Molecular Mass) of Hydrocarbons by Thermo- electric Measurement of Vapor Pressure,’’ which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Styrene-isobutylene copolymers (weight average molecular For use only in coatings for paper and paperboard intended for weight not less than 6,300). use in contact under conditions of use D G described in table 2 of paragraph (c) of this section, with food of Types I, II, IV–B, VI–B, VII–B, and VIII described in table 1 of paragraph (c) of this section; and limited to use at a level not to exceed 40 percent by weight of the coating solids. Styrene-maleic anhydride copolymers ...... For use only as a coating or component of coatings and limited for use at a level not to exceed 2 percent by weight of paper or paperboard substrate. Styrene-methacrylic acid copolymers containing no more than 5 weight percent of polymer units derived from methacrylic acid. Styrene-vinylidene chloride copolymers containing not more For use only as coatings or components of coatings. than 40 weight percent of vinylidene chloride in the finished copolymers. The finished copolymers may contain not more than 5 weight percent of total polymer units derived from acrylic acid, fumaric acid, itaconic acid, and/or methacrylic acid. 2-Sulfoethyl methacrylate, sodium salt [Chemical Abstracts For use only in copolymer coatings under conditions of use E, Service No. 1804–87–1]. F, and G described in paragraph (c) of this section, table 2, and limited to use at a level not to exceed 2.0 percent by weight of the dry copolymer coating. a[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxypoly (oxy- For use only as a surface-active agent at levels not to exceed ethylene) hydrogen sulfate, sodium salt mixture with a-[p- 3 percent by weight of vinyl acetate polymer with ethylene (1,1,3,3-tetramethylbutyl)-phenyl]-omega-hydroxypoly (oxy- and N-(hydroxymethyl) acrylamide intended for use in coat- ethylene) with both substances having a poly(oxyethylene) ings for paper and paperboard intended for use in contact content averaging 3 moles. with foods: 1. Of the types identified in paragraph (c) of this section, table 1, under Types I, II, III, IV, VI–B, and VII, and under the conditions of use described in paragraph (c) of this section, table 2, conditions of use E, F, and G. 2. Of the types identified in paragraph (c) of this section, table 1, under Types V, VIII and IX and under the conditions of use described in paragraph (c) of this section, table 2, conditions of use C, D, E, F, and G. Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecylsulfo-succina- For use only as an emulsifier in resin latex coatings, and lim- mate. ited to use at a level not to exceed 0.05% by weight of the coating solids. Toluenesulfonamide-formaldehyde resins.

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List of substances Limitations

Vinyl acetate copolymers produced by copolymerizing vinyl acetate with one or more of the monomers acrylamide, acrylic acid, acrylonitrile, bicyclo-[2.2.1]hept-2-ene-6-methylacrylate, butyl acrylate, crotonic acid, decyl acrylate, diallyl fumarate, diallyl maleate, diallyl phthalate, dibutyl fumarate, dibutyl itaconate, dibutylmaleate, di(2-ethylhexyl) maleate, divinyl benzene, ethyl acrylate, 2-ethyl-hexyl acrylate, fumaric acid, itaconic acid, maleic acid, methacrylic acid, methyl acrylate, methyl methacrylate, mono(2-ethylhexyl) maleate, monoethyl maleate, styrene, vinyl butyrate, vinyl crotonate, vinyl hexoate, vinylidene chloride, vinyl pelargonate, vinyl propionate, vinyl pyrrolidone, vinyl stearate, and vinyl sulfonic acid. The finished copolymers shall contain at least 50 weight percent of polymer units derived from vinyl acetate and shall contain no more than 5 weight percent of total polymer units derived from acrylamide, acrylic acid, crotonic acid, decyl acrylate, dibutyl itaconate, di(2-ethylhexyl) maleate, fumaric acid, itaconic acid, maleic acid, methacrylic acid, mono(2- ethylhexyl) maleate, monoethyl maleate, vinyl butyrate, vinyl hexoate, vinyl pelargonate, vinyl propionate, vinyl stearate, and vinyl sulfonic acid. Vinyl acetate polymer with ethylene and N-(hydroxymethyl) ac- For use only in coatings for paper and paperboard intended for rylamide containing not more than 6 weight percent of total use in contact with foods: polymer units derived from N-(hydroxymethyl) acrylamide. 1. Of the types identified in paragraph (c) of this section, table 1, under Types I, II, III, IV, VI B, and VII and under the conditions of use described in paragraph (c) of this section, table 2, conditions of use E, F, and G. 2. Of the types identified in paragraph (c) of this section, table 1, under Types V, VIII, and IX and under the conditions of use described in paragraph (c) of this section, table 2, conditions of use C, D, E, F, and G. Vinyl chloride copolymers produced by copolymerizing vinyl chloride with one or more of the monomers acrylonitrile; fumaric acid and its methyl, ethyl, propyl, butyl, amyl, hexyl, heptyl, or octyl esters; maleic acid and its methyl, ethyl, propyl, butyl, amyl, hexyl, heptyl, or octyl esters; maleic anhydride; 5-norbornene-2, 3-dicarboxylic acid, mono-n-butyl ester; vinyl acetate-and vinylidene chloride. The finished copolymers shall contain at least 50 weight percent of polymer units derived from vinyl chloride: shall contain no more than 5 weight percent of total polymer units derived from fumaric and/or maleic acid and/or their methyl, ethyl, propyl, butyl, amyl, heptyl, or octyl monoesters or from maleic anhydride or from mono-n-butyl ester of 5-norbornene-2, 3-dicarboxylic acid (however, in any case the finished copolymers shall contain no more than 4 weight percent of total polymer units derived from mono-n-butyl ester of 5-norbornene-2,3- dicarboxylic acid). Vinyl chloride-vinyl acetate hydroxyl-modified copolymers. Vinyl chloride-vinyl acetate hydroxyl-modified copolymers reacted with trimellitic anhydride. Vinylidene chloride copolymers produced by copolymerizing vinylidene chloride with one or more of the monomers acrylamide acrylic acid, acrylonitrile, butyl acrylate, butyl methacrylate ethyl acrylate, ethyl methacrylate, fumaric acid, itaconic acid, methacrylic acid, methyl acrylate, methyl methacrylate, octadecyl methacrylate, propyl acrylate, propyl methacrylate, vinyl chloride and vinyl sulfonic acid. The finished copolymers shall contain at least 50 weight percent of polymer units derived from vinylidene chloride; and shall contain no more than 5 weight percent of total polymer units derived from acrylamide, acrylic acid, fumaric acid, itaconic acid, methacrylic acid, octadecyl methacrylate, and vinyl sulfonic acid. Colorants:. Aluminum ...... For use as a colorant only. Aluminum hydrate ...... Do. Aluminum and potassium silicate (mica) ...... Do. Aluminum mono-, di-, and tristearate ...... Do. Aluminum silicate (China clay) ...... Do. Barium sulfate ...... Do. Bentonite ...... Do. Bentonite, modified with dimethyldioctadecylammonium ion Do. Burnt umber ...... Do.

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List of substances Limitations

Calcium carbonate ...... Do. Calcium silicate ...... Do. Calcium sulfate ...... Do. Carbon black (channel process) ...... Do. Cobalt aluminate ...... Do. Diatomaceous earth ...... Do. Iron oxides ...... Do. Magnesium oxide ...... Do. Magnesium silicate (talc) ...... Do. Phthalocyanine blue (C.I. pigment blue 15, 15:1, 15:2, Do. 15:3, and 15:4; C.I. No. 74160; CAS Reg. No. 147–14– 8). Raw sienna ...... Do. Silica ...... Do. Tartrazine lake (certified FD&C Yellow No. 5 only) ...... Do. Titanium dioxide ...... Do. Titanium dioxide-barium sulfate ...... Do. Titanium dioxide-magnesium ...... Do. silicate. Zinc carbonate ...... Do. Zinc oxide ...... Do.

(c) The food-contact surface of the TABLE 1—TYPES OF RAW AND PROCESSED paper and paperboard in the finished FOODS—Continued form in which it is to contact food, II. Acid, aqueous products; may contain salt or sugar or when extracted with the solvent or sol- both, and including oil-in-water emulsions of low- or high- fat content. vents characterizing the type of food, III. Aqueous, acid or nonacid products containing free oil or and under conditions of time and tem- fat; may contain salt, and including water-in-oil emulsions perature characterizing the conditions of low- or high-fat content. of its intended use as determined from IV. Dairy products and modifications: A. Water-in-oil emulsions, high- or low-fat. tables 1 and 2 of this paragraph, shall B. Oil-in-water emulsions, high- or low-fat. yield net chloroform-soluble extrac- V. Low-moisture fats and oil. tives (corrected for wax, petrolatum, VI. Beverages: mineral oil and zinc extractives as zinc A. Containing up to 8 percent of alcohol. oleate) not to exceed 0.5 milligram per B. Nonalcoholic. C. Containing more than 8 percent alcohol. square inch of food-contact surface as VII. Bakery products other than those included under Types determined by the methods described VIII or IX of this table: in paragraph (d) of this section. A. Moist bakery products with surface containing free fat or oil. TABLE 1—TYPES OF RAW AND PROCESSED B. Moist bakery products with surface containing no free fat or oil. FOODS VIII. Dry solids with the surface containing no free fat or oil I. Nonacid, aqueous products; may contain salt or sugar or (no end test required). both (pH above 5.0). IX. Dry solids with the surface containing free fat or oil. TABLE 2—TEST PROCEDURES WITH TIME TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF EXTRACTIVES FROM THE FOOD-CONTACT SURFACE OF UNCOATED OR COATED PAPER AND PAPER- BOARD, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES

Food-simulating solvents 8 percent al- 50 percent al- Types of food Water Heptane 1 Condition of use (see table 1) cohol cohol Time and Time and Time and Time and tem- temperature temperature temperature perature

A. High temperature heat-sterilized (e.g., I, IV–B, VII–B ..... 250 °F, 2 hr ...... over 212 °F). III, IV–A, VII–A ...... do ...... 150 °F, 2 hr ...... B. Boiling water sterilized ...... II, VII–B ...... 212 °F, 30 ...... min. III, VII–A ...... do ...... 120 °F, 30 ...... min. C. Hot filled or pasteurized above 150 °F .... II, IV–B, VII–B .... Fill boiling, ...... cool to 100 °F.

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TABLE 2—TEST PROCEDURES WITH TIME TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF EXTRACTIVES FROM THE FOOD-CONTACT SURFACE OF UNCOATED OR COATED PAPER AND PAPER- BOARD, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES—Continued

III, IV–A, VII–A ...... do ...... 120 °F, 15 ...... min. V, IX ...... do ...... D. Hot filled or pasteurized below 150 °F ..... II, IV–B, VI–B, ...... VII–B ...... 150 °F, 2 hr ...... III, IV–A, VII–A ...... do ...... 100 °F, 30 ...... min. V, IX ...... do ...... VI–A ...... 150 °F, 2 hr ...... VI–C ...... 150 °F, 2 hr. E. Room temperature filled and stored (no I, II, IV–B, VI–B, 120 °F, 24 hr ...... thermal treatment in the container). VII–B. III, IV–A, VII–A ...... do ...... 70 °F, 30 ...... min. V, IX ...... do ...... VI–A ...... 120 °F, 24 hr ...... VI–C ...... 120 °F, 24 hr. F. Refrigerated storage (no thermal treat- III, IV–A, VII–A ... 70 °F, 48 hr 70 °F, 30 ...... ment in the container). min. I, II, IV–B, VI–B, ...... do ...... VII–B. VI–A ...... 70 °F, 48 hr ...... VI–C ...... 70 °F, 48 hr. G. Frozen storage (no thermal treatment in I, II, IV–B, VII–B 70 °F, 24 hr ...... the container). III, VII–A ...... do ...... 70 °F, 30 ...... min. H. Frozen or refrigerated storage: Ready- prepared foods intended to be reheated in container at time of use: 1. Aqueous or oil-in-water emulsion of I, II, IV–B, VII–B 212 °F, 30 ...... high- or low-fat. min. 2. Aqueous, high- or low-free oil or fat .. III, IV–A, VII–A, ...... do ...... 120 °F, 30 ...... IX. min. 1 Heptane extractability results must be divided by a factor of five in arriving at the extractability for a food product having water-in-oil emulsion or free oil or fat. Heptane food-simulating solvent is not required in the case of wax-polymer blend coatings for corrugated paperboard containers intended for use in bulk packaging of iced meat, iced fish, and iced poultry.

(d) Analytical methods—(1) Selection of freshly demineralized (deionized) dis- extractability conditions. First ascertain tilled water. the type of food product (table 1, para- (ii) n-Heptane. Reagent grade, freshly graph (c) of this section) that is being redistilled before use, using only mate- packed commercially in the paper or rial boiling at 208 °F. paperboard and the normal conditions (iii) Alcohol. 8 or 50 percent (by vol- of thermal treatment used in pack- ume), prepared from undenatured 95 aging the type of food involved. Using percent ethyl alcohol diluted with table 2, paragraph (c) of this section, demineralized (deionized) distilled select the food-simulating solvent or water. solvents and the time-temperature ex- (iv) Chloroform. Reagent grade, fresh- aggerations of the paper or paperboard ly redistilled before use, or a grade use conditions. Having selected the ap- having an established consistently low propriate food-simulating solvent or blank. solvents and the time-temperature ex- (3) Selection of test method. Paper or aggeration over normal use, follow the paperboard ready for use in packaging applicable extraction procedure. shall be tested by use of the extraction (2) Reagents—(i) Water. All water used cell described in ‘‘Official Methods of in extraction procedures should be Analysis of the Association of Official

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Analytical Chemists,’’ 13th Ed. (1980), (i) Five 21⁄2-inch-square aluminum sections 21.010–21.015, under ‘‘Exposing screens (standard aluminum window Flexible Barrier Materials for Extrac- screening is acceptable). tion,’’ which is incorporated by ref- (j) One wire capable of supporting erence (copies may be obtained from sample stack. the Association of Official Analytical (ii) Procedure. (a) For each extrac- Chemists International, 481 North tion, accurately cut eight 21⁄2-inch- Frederick Ave., suite 500, Gaithersburg, square samples from the formed paper MD 20877–2504, or may be examined at or paperboard product to be tested. the Office of the Federal Register, 800 (b) Carefully stack the eight 21⁄2-inch- North Capitol Street, NW., suite 700, square samples and the five 21⁄2-inch- Washington, DC 20408); also described square aluminum screens in sandwich in ASTM method F34–76 (Reapproved form such that the food-contact side of 1980), ‘‘Standard Test Method for Liq- each sample is always next to an alu- uid Extraction of Flexible Barrier Ma- minum screen, as follows: Screen, sam- terials,’’ which is incorporated by ref- ple, sample, screen, sample, sample, erence (copies may be obtained from screen, etc. Clip the sandwich together the American Society for Testing Ma- carefully with a No. 2 paper clip, leav- terials, 1916 Race St., Philadelphia, PA ing just enough space at the top to slip 19103, or may be examined at the Office a wire through. of the Federal Register, 800 North Cap- (c) Place an 800-milliliter beaker con- itol Street, NW., suite 700, Washington, taining 100-milliliters of the appro- DC 20408), except that formed paper and priate food-simulating solvent into the paperboard products may be tested in constant temperature bath, cover with the container by adapting the in-con- a watch glass and condition at the de- tainer methods described in § 175.300(e) sired temperature. of this chapter. Formed paper and pa- (d) After conditioning, carefully perboard products such as containers lower the sample sandwich with tongs and lids, that cannot be tested satisfac- into the beaker. torily by any of the above methods (e) At the end of the extraction pe- may be tested in specially designed ex- riod, using the tongs, carefully lift out traction equipment, usually consisting the sample sandwich and hang it over of clamping devices that fit the closure the beaker with the wire. or container so that the food-contact (f) After draining, pour the food-sim- surface can be tested, or, if flat sam- ulating solvent solution into a tared ples can be cut from the formed paper 250-milliliter beaker. Rinse the 800-mil- or paperboard products without de- liliter beaker three times, using a total stroying the integrity of the food-con- of not more than 50 milliliters of the tact surface, they may be tested by required solvent. adapting the following ‘‘sandwich’’ (g) Determine total nonvolatile ex- method: tractives in accordance with paragraph (i) Apparatus. (a) Thermostated (±1.0 (d)(5) of this section. °F) water bath, variable between 70 °F (4) Selection of samples. Quadruplicate and 120 °F water bath cover capable of samples should be tested, using for holding at least one 800-milliliter beak- each replicate sample the number of er partially submersed in bath. cups, containers, or preformed or con- (b) Analytical balance sensitive to 0.1 verted products nearest to an area of milligram with an approximate capac- 100 square inches. ity of 100 grams. (5) Determination of amount of extrac- (c) Tongs. tives—(i) Total residues. At the end of (d) Hood and hot-plate facilities. the exposure period, remove the test (e) Forced draft oven. container or test cell from the oven and combine the solvent for each rep- For each extraction, the following ad- licate in a clean Pyrex (or equivalent) ditional apparatus is necessary: flask or beaker being sure to rinse the (f) One No. 2 paper clip. test container or cell with a small (g) One 800-milliliter beaker with quantity of clean solvent. Evaporate watch-glass cover. the food-simulating solvents to about (h) One 250-milliliter beaker. 100 milliliters in the flask or beaker,

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and transfer to a clean, tared evaporate the total down to a few mil- evaporating dish (platinum or Pyrex), liliters on a low-temperature hotplate. washing the flask three times with The last few milliliters should be evap- small portions of solvent used in the orated in an oven maintained at ap- extraction procedure, and evaporate to proximately 221 °F. Cool the a few milliliters on a nonsparking, low- evaporating dish in a desiccator for 30 temperature hotplate. The last few minutes and weigh to the nearest 0.1 milliliters should be evaporated in an milligram to get the chloroform-solu- oven maintained at a temperature of ble extractives residue (′). This ′ is sub- approximately 221 °F. Cool the stituted for e in the equations in para- evaporating dish in a desiccator for 30 graph (d)(5)(i) (a) and (b) of this sec- minutes and weigh the residue to the tion. If the chloroform-soluble extrac- nearest 0.1 milligram, (e). Calculate the tives in milligrams per square inch extractives in milligrams per square still exceeds the limitation prescribed inch of the container or sheeted paper in paragraph (c) of this section, proceed or paperboard surface. to paragraph (d)(5)(iii) of this section (a) Water and 8- and 50-percent alcohol. (method for determining corrected Milligrams extractives per square chloroform-soluble extractives res- inch=(e)/(s). (b) Heptane. Milligrams extractives idue). per square inch=(e)/(s)(F) (iii) Corrected chloroform-soluble extractives residue—(a) Correction for zinc where: extractives. Ash the residue in the e=Milligrams extractives per sample tested. evaporating dish by heating gently s=Surface area tested, in square inches. F=Five, the ratio of the amount of extrac- over a Meker-type burner to destroy tives removed by heptane under exagger- organic matter and hold at red heat for ated time-temperature test conditions about 1 minute. Cool in the air for 3 compared to the amount extracted by a fat minutes, and place the evaporating or oil under exaggerated conditions of dish in the desiccator for 30 minutes thermal sterilization and use. and weigh to the nearest 0.1 milligram. e′=Chloroform-soluble extractives residue. ee′=Corrected chloroform-soluble extractives Analyze this ash for zinc by standard residue. Association of Official Agricultural e′ or ee′ is substituted for e in the above equa- Chemists methods or equivalent. Cal- tions when necessary. culate the zinc in the ash as zinc oleate, and subtract from the weight of If when calculated by the equations in chloroform-soluble extractives residue paragraph (d)(5)(i) ( ) and ( ) of this a b (′) to obtain the zinc-corrected chloro- section, the extractives in milligrams form-soluble extractives residue (e′). per square inch exceeds the limitations This e′ is substituted for e in the equa- prescribed in paragraph (c) of this sections in paragraph (d)(5)(i) (a) and (b) of tion, proceed to paragraph (d)(5)(ii) of this section. this section (method for determining the amount of chloroform-soluble ex- (b) Correction for wax, petrolatum, and tractives residues). mineral oil—(1) Apparatus. Standard 10 (ii) Chloroform-soluble extractives res- millimeter inside diameter × 60 centi- idue. Add 50 milliliters of chloroform meter chromatographic column (or (freshly distilled reagent grade or a standard 50-milliliter buret with an in- grade having an established consist- side diameter of 10–11 millimeters) ently low blank) to the dried and with a stopcock of glass, weighed residue, (e), in the evaporating perfluorocarbon resin, or equivalent dish obtained in paragraph (d)(5)(i) of material. The column (or buret) may this section. Warm carefully, and filter be optionally equipped with an integral through Whatman No. 41 filter paper coarse, fritted glass disc and the top of (or equivalent) in a Pyrex (or equiva- the column (or buret) may be option- lent) funnel, collecting the filtrate in a ally fitted with a 100-millimeter sol- clean, tared evaporating dish (platinum vent reservoir. or Pyrex). Repeat the chloroform ex- (2) Preparation of column. Place a traction, washing the filter paper with snug pledget of fine glass wool in the this second portion of chloroform. Add bottom of the column (or buret) if the this filtrate to the original filtrate and column (or buret) is not equipped with

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integral coarse, fritted glass disc. Over- the evaporating dish to dryness on a lay the glass wool pledget (or fritted steam bath. Dry the residue for 15 min- glass disc) with a 15–20 millimeter deep utes in an oven maintained at a tem- layer of fine sand. Measure in a grad- perature of approximately 221 °F. Cool uated cylinder 15 milliliters of the evaporating dish in a desiccator for chromatographic grade aluminum 30 minutes and weigh the residue to the oxide (80–200 mesh) that has been tight- nearest 0.1 milligram. Subtract the ly settled by tapping the cylinder. weight of the residue from the weight Transfer the aluminum oxide to the of chloroform-soluble extractives res- chromatographic tube, tapping the idue (′) to obtain the wax-, petrolatum- tube during and after the transfer so as , and mineral oil-corrected chloroform- to tightly settle the aluminum oxide. soluble extractives residue (e′). This e′ Overlay the layer of aluminum oxide is substituted for e in the equations in with a 1.0–1.5 centimeter deep layer of paragraph (d)(5)(i) (a) and (b) of this anhydrous sodium sulfate and on top of section. this place an 8–10 millimeter thick plug of fine glass wool. Next carefully add (ii) For chloroform residues weighing about 25 milliliters of heptane to the more than 0.5 gram. Redissolve the column with stopcock open, and allow dried and weighed chloroform-soluble the heptane to pass through the col- extract residue as described in para- umn until the top level of the liquid graph (d)(5)(iii)(b)(3)(i) of this section just passes into the top glass wool plug using proportionately larger quantities in the column, and close stopcock. of heptane. Transfer the heptane solu- (3) Chromatographing of sample ex- tion to an appropriate-sized volumetric tract—(i) For chloroform residues weigh- flask (i.e., a 250-milliliter flask for ing 0.5 gram or less. To the dried and about 2.5 grams of residue) and adjust weighed chloroform-soluble extract to volume with additional heptane. Pi- residue in the evaporating dish, ob- pette out an aliquot (about 50 milli- tained in paragraph (d)(5)(ii) of this liters) calculated to contain 0.1–0.5 section, add 20 milliliters of heptane gram of the chloroform-soluble extract and stir. If necessary, heat carefully to residue and analyze dissolve the residue. Additional chromatographically as described in heptane not to exceed a total volume of paragraph (d)(5)(iii)(b)(3)(i) of this sec- 50 milliliters may be used if necessary tion. In this case the weight of the to complete dissolving. Cool to room dried residue from the heptane eluate temperature. (If solution becomes must be multiplied by the dilution fac- cloudy, use the procedure in paragraph tor to obtain the weight of wax, petro- (d)(5)(iii)(b)(3)(ii) of this section to ob- latum, and mineral oil residue to be tain an aliquot of heptane solution cal- subtracted from the weight of chloro- culated to contain 0.1–0.5 gram of chlo- form-soluble extractives residue (′) to roform-soluble extract residue.) Trans- obtain the wax-, petrolatum-, and min- fer the clear liquid solution to the col- eral oil-corrected chloroform-soluble umn (or buret). Rinse the dish with 10 extractives residue (e′). This e′ is sub- millimeters of additional heptane and stituted for e in the equations in para- add to column. Allow the liquid to pass graph (d)(5)(i) (a) and (b) of this sec- through the column into a clean, tared tion. (Note: In the case of chloroform- evaporating dish (platinum or Pyrex) at a dropwise rate of about 2 milliliters soluble extracts which contain high per minute until the liquid surface melting waxes (melting point greater ° reaches the top glass wool plug; then than 170 F), it may be necessary to di- close the stopcock temporarily. Rinse lute the heptane solution further so the Pyrex flask which contained the that a 50-milliliter aliquot will contain filtrate with an additional 10–15 milli- only 0.1–0.2 gram of the chloroform- liters of heptane and add to the col- soluble extract residue.) umn. Wash (elute) the column with (e) Acrylonitrile copolymers identi- more heptane collecting about 100 mil- fied in this section shall comply with liliters of total eluate including that the provisions of § 180.22 of this chap- already collected in the evaporating ter, except where the copolymers are dish. Evaporate the combined eluate in restricted to use in contact with food

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only of the type identified in paragraph subject to the provisions of this sec- (c), table 1 under Category VIII. tion. [42 FR 14554, Mar. 15, 1977] (a) The substances are used in amounts not to exceed that required to EDITORIAL NOTE: For FEDERAL REGISTER ci- accomplish their intended physical or tations affecting § 176.170, see the List of CFR technical effect, and are so used as to Sections Affected, which appears in the Finding Aids section of the printed volume accomplish no effect in food other than and on GPO Access. that ordinarily accomplished by packaging. § 176.180 Components of paper and pa- (b) The substances permitted to be perboard in contact with dry food. used include the following: The substances listed in this section (1) Substances that by § 176.170 and may be safely used as components of other applicable regulations in parts the uncoated or coated food-contact 170 through 189 of this chapter may be surface of paper and paperboard in- safely used as components of the tended for use in producing, manufac- uncoated or coated food-contact sur- turing, packing, processing, preparing, face of paper and paperboard, subject treating, packaging, transporting, or to the provisions of such regulation. holding dry food of the type identified (2) Substances identified in the fol- in § 176.170(c), table 1, under Type VIII, lowing list:

List of substances Limitations

Acrylamide polymer with sodium 2-acrylamido-2- For use at a level not to exceed 0.015 weight percent of dry methylpropane-sulfonate (CAS Reg. No. 38193–60–1). fiber. (2-Alkenyl) succinic anhydrides in which the alkenyl groups are derived from olefins which contain not less than 78 percent C30 and higher groups (CAS Reg. No. 70983–55–0).. 4-[2-[2-(2-Alkoxy(C12-C15) ethoxy) ethoxy]ethyl]disodium sulfo- For use as a polymerization emulsifier and latex emulsion sta- succinate. bilizer at levels not to exceed 5 percent by weight of total emulsion solids. Alkyl mono- and disulfonic acids, sodium salts (produced from n-alkanes in the range of C10-C18 with not less than 50 percent C14-C16).. Aluminum and calcium salts of FD & C dyes on a substrate of Colorant. alumina. Ammonium nitrate.. Amylose.. Barium metaborate ...... For use as preservative in coatings and sizings. 1,2-Benzisothiazolin-3-one (CAS Registry No. 2634–33–5) ...... For use only as a preservative in paper coating compositions and limited to use at a level not to exceed 0.02 mg/in2 (0.0031 mg/cm2) of finished paper and paperboard. N,N′-Bis(hydroxyethyl)lauramide. Bis(trichloromethyl) sulfone C.A. Registry No. 3064–70–8 ...... For use only as a preservative in coatings. Borax ...... For use as preservative in coatings. Boric acid ...... Do. sec-Butyl alcohol.. Butyl benzyl phthalate.. Candelilla wax.. Carbon tetrachloride.. Castor oil, polyoxyethylated (42 moles ethylene oxide).. Cationic soy protein hydrolyzed (hydrolyzed soy protein isolate For use only as a coating adhesive, pigment structuring agent, modified by treatment with 3-chloro-2-hydroxypropyl- and fiber retention aid. trimethylammonium chloride). Cationic soy protein (soy protein isolate modified by treatment For use only as a coating adhesive, pigment structuring agent, with 3-chloro-2-hydroxypropyltrimethyl-ammonium chloride). and fiber retention aid. Chloral hydrate ...... Polymerization reaction-control agent. N-Cyclohexyl-p-toluene sulfonamide.. 2,5-Di-tert-butyl hydroquinone. Diethanolamine.. Diethylene glycol dibenzoate (CAS Reg. No. 120–55–8) ...... For use only as a plasticizer in polymeric substances. Diethylene glycol monobutyl ether.. Diethylene glycol monoethyl ether.. Diethylenetriamine.. N,N-Diisopropanolamide of tallow fatty acids.. N-[(dimethylamino)methyl]acrylamide polymer with acrylamide and styrene..

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List of substances Limitations

N,N-Dioleoylethylenediamine, N,N-dilinoeoyl-ethylenediamine, and N-oleoyl-N-linoleoyl-ethylenediamine mixture produced when tall oil fatty acids are made to react with ethylenediamine such that the finished mixture has a melting point of 212°–228 °F, as determined by ASTM method D127–60, and an acid value of 10 maximum. ASTM Method D127–60 ‘‘Standard Method of Test for Melting Point of Petrolatum and Microcrystalline Wax’’ (Revised 1960) is incorporated by reference. Copies are available from University Microfilms International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.. Diphenylamine.. Dipropylene glycol dibenzoate (CAS Reg. No. 27138–31–4) ..... For use only as plasticizer in polymeric substances. Disodium N-octadecylsulfosuccinamate.. tert-Dodecyl thioether of polyethylene glycol.. Erucamide (erucylamide).. Ethanedial, polymer with tetrahydro-4-hydroxy-5-methyl- 2(1H)pyrimidinone, propoxylated.. Ethylene oxide ...... Fumigant in sizing. Ethylene oxide adduct of mono-(2-ethylhexyl) o-phosphate..

Fatty acid (C12-C18) diethanolamide.. Fish oil fatty acids, hydrogenated, potassium salt.. Formaldehyde.. Glyceryl monocaprate.. Glyceryl tribenzoate (CAS Reg. No. 614–33–5) ...... For use only as a plasticizer in polymeric coatings. Glyoxal.. Glyoxal-urea-formaldehyde condensate (CAS Reg. No. 27013– For use as an insolubilizer for starch in coatings. 01–0) formed by reaction in the molar ratio of approximately 47:33:15, respectively. The reaction product has a number average molecular weight of 278±14 as determined by a suitable method. Glyoxal-urea polymer (CAS Reg. No. 53037–34–6) ...... For use as an insolubilizer for starch. Hexamethylenetetramine ...... Polymerization crosslinking agent for protein, including casein. As neutralizing agent with myristochromic chloride complex and stearato-chromic chloride complex. Hexylene glycol (2-methyl-2,4-pentanediol).. Hydroabietyl alcohol.. 5-Hydroxymethoxymethyl-1-aza-3,7-dioxabicyclo[3.3.0] octane, For use only as an antibacterial preservative. 5-hydroxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, and 5- hydroxypoly-[methyleneoxy]methyl-1-aza-3,7- dioxabicyclo[3.3.0] octane mixture.

Imidazolium compounds, 2–(C17 and C17-unsaturated alkyl)-1– For use only at levels not to exceed 0.5 percent by weight of [2–(C18 and C18-unsaturated amido)ethyl]-4,5-dihydro-1- the dry paper and paperboard. methyl, methyl sulfates (CAS Reg. No. 72749–55–4).. Isopropanolamine hydrochloride.. Isopropyl m- and p-cresol (thymol derived).. Itaconic acid.. Maleic anhydride-diisobutylene copolymer, ammonium or sodium salt.. Melamine-formaldehyde modified with: Basic polymer. Alcohols (ethyl, butyl, isobutyl, propyl, or isopropyl). Diethylenetriamine. Imino-bis-butylamine. Imino-bis-ethyleneimine. Imino-bis-propylamine. Polyamines made by reacting ethylenediamine or trimethylenediamine with dichloroethane or dichloropropane. Sulfanilic acid. Tetraethylenepentamine. Triethylenetetramine. Methyl alcohol.. Methyl esters of mono-, di-, and tripropylene glycol.. Methyl napthalene sulfonic acid-formaldehyde condensate, sodium salt.. Methylated poly(N-1,2-dihydroxyethylene-1,3-imidazolidin-2- For use only only as an in solubilizer for starch. one).

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List of substances Limitations

Modified polyacrylamide resulting from an epichlorohydrin addi- For use only as a dry strength and pigment retention aid agent tion to a condensate of formaldehyde-dicyandiamide- employed prior to the sheetforming operation in the manu- diethylene triamine and which product is then reacted with facture of paper and paperboard and used at a level not to polyacrylamide and urea to produce a resin having a nitro- exceed 1 percent by weight of dry fibers. gen content of 5.6 to 6.3 percent and having a minimum viscosity in 56 percent-by-weight aqueous solution of 200 centipoises at 25 °C, as determined by LVT-series Brookfield viscometer using a No. 4 spindle at 60 r.p.m. (or equivalent method). Mono- and di(2-alkenyl)succinyl esters of polyethylene glycol For use only as an emulsifier. containing not less than 90 percent of the diester product and in which the alkenyl groups are derived from olefins that contain not less than 95 percent of C15-C21 groups. Monoglyceride citrate.. Myristo chromic chloride complex.. Napthalene sulfonic acid-formaldehyde condensate, sodium salt.. Nickel.. b-Nitrostyrene ...... Basic polymer. Octadecanoic acid, reaction products with 2-[(2- For use prior to sheet forming at levels not to exceed 12 aminoethyl)amino]ethanol and urea (CAS Reg. No. 68412– pounds per ton of paper. 14–6), and the acetate salts thereof (CAS Reg. No. 68784– 21–4), which may be emulsified with ethoxylated tallow alkyl amines (CAS Reg. No. 61791–26–2). a-cis-9-Octadecenyl-omega-hydroxypoly (oxyethylene); the octadecenyl group is derived from oleyl alcohol and the poly(oxyethylene) content averages not less than 20 moles.. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) sulfate, ammonium salt; the nonyl group is a propylene trimer isomer and the poly (oxyethylene) content averages 9 or 30 moles.. Oleic acid reacted with N-alkyl-(C16-C18) trimethylenediamine.. Oxidized soy isolate having 50 to 70 percent of its cystine resi- For use as a binder adhesive component of coatings. dues oxidized to cysteic acid. Petroleum alicyclic hydrocarbon resins, or the hydrogenated For use as modifiers at levels up to 30 weight-percent of the product thereof, complying with the identity prescribed in solids content of wax-polymer blend coatings. § 176.170(b)(2). Petroleum hydrocarbon resins (produced by the catalytic polymerization and subsequent hydrogenation of styrene, vinyltoluene, and indene types from distillates of cracked petroleum stocks).. Petroleum hydrocarbons, light and odorless.. o-Phthalic acid modified hydrolyzed soy protein isolate.. Pine oil.. Poly(2-aminoethyl acrylate nitrate-co-2-hydroxypropyl acrylate) complying with the identity described in § 176.170(a).. Polyamide-epichloro hydrin modified resins resulting from the reaction of the initial caprolactam-itaconic acid product with diethylenetriamine and then condensing this prepolymer with epichlorohydrin to form a cationic resin having a nitrogen content of 11–15 percent and chlorine level of 20–23 percent on a dry basis.. Polyamide-ethyleneimine-epichlorohydrin resin is prepared by reacting equimolar amounts of adipic acid and three amines (21 mole percent of 1,2-ethanediamine, 51 mole percent of N-(2-aminoethyl)-1,3-propanediamine, and 28 mole percent of N, N′-1,2-ethanediylbis(1,3-propanediamine)) to form a basic polyamidoamine which is modified by reaction with ethyleneimine (5.5:1.0 ethyleneimine:polyamidoamine). The modified polyamidoamine is reacted with a crosslinking agent made by condensing approximately 34 ethylene glycol units with (chloromethyl)oxirane, followed by pH adjustment with formic acid or sulfuric acid to provide a finished product as a formate (CAS Reg. No. 114133–44–7) or a sulfate (CAS Reg. No. 167678–43–5), having a weight-average molecular weight of 1,300,000 and a number-average molecular weight of 16,000.. Polyamide-ethyleneimine-epichlorohydrin resin (CAS Reg. No. 115340–77–7), prepared by reacting equimolar amounts of adipic acid and N-(2-aminoethyl)-1,2-ethanediamine to form a basic polyamidoamine which is modified by reaction with ethyleneimine, and further reacted with formic acid and (chloromethyl)oxirane-a-hydro-omega-hydroxypoly(oxy-1,2- ethanediyl)..

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List of substances Limitations

Polybutene, hydrogenated; complying with the identity prescribed under § 178.3740(b) of this chapter.. Poly [2-(diethylamino) ethyl methacrylate] phosphate.. Polyethylene glycol (200) dilaurate.. Polyethylene glycol monoisotridecyl ether sulfate, sodium salt For use only as a surfactant at levels not to exceed 3 percent (CAS Reg. No. 150413–26–6). in latex formulations used in pigment binders for paper and paperboard. Polymers: Homopolymers and copolymers of the following Basic polymer. monomers: Acrylamide. Acrylic acid and its methyl, ethyl, butyl, propyl, or octyl esters. Acrylonitrile. Butadiene. Crotonic acid. Cyclol acrylate. Decyl acrylate. Diallyl fumarate. Diallyl maleate. Diallyl phthalate. Dibutyl fumarate. Dibutyl itaconate. Dibutyl maleate. Di(2-ethylhexyl) maleate. Dioctyl fumarate. Dioctyl maleate. Divinylbenzene. Ethylene. 2-Ethylhexyl acrylate. Fumaric acid. Glycidyl methacrylate. 2-Hydroxyethyl acrylate. N-(Hydroxymethyl) acrylamide. Isobutyl acrylate. Isobutylene. Isoprene. Itaconic acid. Maleic anhydride and its methyl or butyl esters. Methacrylic acid and its methyl, ethyl, butyl, or propyl esters. Methylstyrene. Mono(2-ethylhexyl) maleate. Monoethyl maleate. 5-Norbornene-2,3-dicarboxylic acid, mono-n-butyl ester. Styrene. Vinyl acetate. Vinyl butyrate. Vinyl chloride. Vinyl crotonate. Vinyl hexoate. Vinylidene chloride. Vinyl pelargonate. Vinyl propionate. Vinyl pyrrolidone. Vinyl stearate. Vinyl sulfonic acid. Polymer prepared from urea, ethanedial, formaldehyde, and For use only as a starch and protein reactant in paper and pa- propionaldehyde (CAS Reg. No. 106569–82–8). perboard coatings. Polyoxyethylene (minimum 12 moles) ester of tall oil (30%– 40% rosin acids).. Polyoxypropylene-polyoxyethylene glycol (minimum molecular weight 1,900).. Polyvinyl alcohol.. Potassium titanate fibers produced by calcining titanium dioxide, potassium chloride, and potassium carbonate, such that the finished crystalline fibers have a nominal diameter of 0.20–0.25 micron, a length-to-diameter ratio of approximately 25:1 or greater, and consist principally of K2Ti4O9 and K2Ti 6O13.. Sodium diisobutylphenoxy diethoxyethyl sulfonate.. Sodium diisobutylphenoxy monoethoxy ethylsulfonate.. Sodium n-dodecylpolyethoxy (50 moles) sulfate.. Sodium isododecylphenoxypolyethoxy (40 moles) sulfate.. Sodium N-methyl-N-oleyl taurate.. Sodium methyl siliconate..

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List of substances Limitations

Sodium nitrite.. Sodium polyacrylate.. Sodium bis-tridecylsulfosuccinate.. Sodium xylene sulfonate.. Stearato chromic chloride complex.. Styrene-allyl alcohol copolymers.. Styrene-methacrylic acid copolymer, potassium salt.. Tetraethylenepentamine ...... Polymerization cross-linking agent. a-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-omega hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and their sodium, potassium, and ammonium salts having a poly(oxyethylene) content averaging 6–9 or 40 moles.. a-[p-(1,1,3,3-Tetramethylbutyl)phenyl or p-nonylphenyl]-omega- hydroxypoly (oxyethylene) where nonyl group is a propylene trimer isomer.. Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecyl sulfosuccinamate.. Toluene.. Triethanolamine.. Triethylenetetramine ...... Polymerization cross-linking agent. Triethylenetetramine monoacetate, partially stearoylated.. Urea-formaldehyde chemically modified with: Alcohol (methyl, ethyl, butyl, isobutyl, propyl, or isopropyl). Aminomethylsulfonic acid. Diaminobutane. Diaminopropane. Diethylenetriamine. N,N′-Dioleoylethylenediamine. Diphenylamine. N,N′-Distearoylethylenediamine. Ethylenediamine. Guanidine. Imino-bis-butylamine. Imino-bis-ethylamine. Imino-bis-propylamine. N-Oleoyl-N′-stearoylethylenediamine. Polyamines made by reacting ethylenediamine or triethylenediamine with dichloroethane or dichloropropane. Tetraethylenepentamine. Triethylenetetramine. Xylene.. Xylene sulfonic acid-formaldehyde condensate, sodium salt.. Zinc stearate..

[42 FR 14554, Mar. 15, 1977]

EDITORIAL NOTE: For additional FEDERAL REGISTER citations affecting § 176.180, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§ 176.200 Defoaming agents used in foaming agents does not exceed the coatings. amount reasonably required to accom- The defoaming agents described in plish the intended physical or technical this section may be safely used as com- effect in the defoaming agents or any ponents of articles intended for use in limitation further provided. producing, manufacturing, packing, (c) Any substance employed in the processing, preparing, treating, pack- production of defoaming agents and aging, transporting, or holding food, which is the subject of a regulation in subject to the provisions of this sec- parts 174, 175, 176, 177, 178 and § 179.45 of tion. this chapter conforms with any speci- (a) The defoaming agents are pre- fication in such regulation. pared as mixtures of substances de- (d) Substances employed in the for- scribed in paragraph (d) of this section. mulation of defoaming agents include: (b) The quantity of any substance (1) Substances generally recognized employed in the formulation of de- as safe in food.

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(2) Substances subject to prior sanc- (3) Substances identified in this para- tion or approval for use in defoaming graph (d)(3) and subject to such limita- agents and used in accordance with tions as are provided: such sanction or approval.

List of substances Limitations

n-Butyl alcohol. tert-Butyl alcohol. Butyl stearate. Castor oil, sulfated, ammonium, potassium, or sodium salt. Cetyl alcohol. Cyclohexane. Cyclohexanol. Diethylene glycol monolaurate. Diethylene glycol monostearate. Dimers and trimers of unsaturated C18 fatty acids derived from: For use only at levels not to exceed 0.1% by weight of total coating solids. Animal and vegetable fats and oils. Tall oil. Dimethylpolysiloxane. a-(Dinonylphenyl)-w-hydroxy-poly(oxy-1,2-ethanediyl), con- For use only in defoaming agents for the production of styrene- taining 7 to 24 moles of ethylene oxide per mole of butadiene coatings at a level not to exceed 0.05 percent by dinonylphenol (CAS Reg. No. 9014–93–1). weight of the finished coating. Dipropylene glycol. Ethyl alcohol. Fats and oils derived from animal, marine, or vegetable sources: Fatty acids derived from animal, marine, or vegetable fats and oils, and salts of such acids, single or mixed, as follows: Aluminum.. Ammonium.. Calcium.. Magnesium.. Potassium.. Sodium.. Zinc.. Formaldehyde ...... For use as preservative of defoamer only. Glyceryl mono-12-hydroxystearate. Glyceryl monostearate. Hexane. Hexylene glycol (2-methyl-2,4-pentanediol). Isobutyl alcohol. Isopropyl alcohol. Kerosene. Lecithin hydroxylated. Methyl alcohol. Methylcellulose. Methyl esters of fatty acids derived from animal, marine, or vegetable fats and oils. Methyl oleate. Methyl palmitate. Mineral oil. Mustardseed oil, sulfated, ammonium, potassium, or sodium salt. Myristyl alcohol. Naphtha. b-Naphthol ...... For use as preservative of defoamer only. Nonylphenol. Odorless light petroleum hydrocarbons ...... As defined in § 178.3650 of this chapter. Oleic acid, sulfated, ammonium, potassium, or sodium salt. Parachlorometacresol ...... For use as preservative of defoamer only. Peanut oil, sulfated, ammonium, potassium, or sodium salt. Petrolatum. Pine oil. Polyacrylic acid, sodium salt ...... As a stabilizer and thickener in defoaming agents containing dimethylpolysiloxane. Polyethylene. Polyethylene, oxidized. Polyethylene glycol (200) dilaurate. Polyethylene glycol (400) dioleate. Polyethylene glycol (600) dioleate. Polyethylene glycol (400) esters of coconut oil fatty acids. Polyethylene glycol (400) monooleate.

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List of substances Limitations

Polyethylene glycol (600) monooleate. Polyethylene glycol (600) monoricinoleate. Polyethylene glycol (400) monostearate. Polyoxybutylene-polyoxypropylene-polyoxyethylene glycol (min. mol. wt. 3,700). Polyoxyethylated (min. 3 mols) cetyl alcohol. Polyoxyethylated (min. 5 mols) oleyl alcohol. Polyoxyethylated (min. 1.5 mols) tridecyl alcohol. Polyoxyethylene (min. 15 mols) ester of rosin. Polyoxyethylene (min. 8 mols) monooleate. Polyoxyethylene (40) stearate. Polyoxypropylated (min. 20 mols) butyl alcohol. Polyoxypropylene glycol (min. mol. wt. 200). Polyoxypropylene (min. 20 mols) oleate butyl ether. Polyoxypropylene-polyoxyethylene glycol (min. mol. wt. 1,900). Polyoxypropylene (min. 40 mols) stearate butyl ether. Potassium pentachlorophenate ...... For use as preservative of defoamer only. Potassium trichlorophenate ...... Do. Propylene glycol monoester of soybean oil fatty acids. Propylene glycol monoester of tallow fatty acids. Ricebran oil, sulfated, ammonium, potassium, or sodium salt. Rosins and rosin derivatives ...... As provided in § 178.3870 of this chapter. Silica. Sodium 2-mercaptobenzothiazole ...... For use as preservative of defoamer only. Sodium pentachlorophenate ...... Do. Sodium trichlorophenate ...... Do. Sperm oil, sulfated, ammonium, potassium, or sodium salt. Stearyl alcohol. Tall oil fatty acids. Tallow fatty acids, hydrogenated or sulfated. Tallow, sulfated, ammonium, potassium, or sodium salt. Triethanolamine. Triisopropanolamine. Waxes, petroleum.

(e) The defoaming agents are used as (b) The defoaming agents are used to follows: prevent or control the formation of (1) The quantity of defoaming agent foam during the manufacture of paper or agents used shall not exceed the and paperboard prior to and during the amount reasonably required to accom- sheet-forming process. plish the intended effect, which is to (c) The quantity of defoaming agent prevent or control the formation of or agents added during the manufac- foam. turing process shall not exceed the (2) The defoaming agents are used in amount necessary to accomplish the the preparation and application of intended technical effect. coatings for paper and paperboard. (d) Substances permitted to be used in the formulation of defoaming agents [42 FR 14554, Mar. 15, 1977, as amended at 62 FR 39772, July 24, 1997] include substances subject to prior sanctions or approval for such use and § 176.210 Defoaming agents used in the employed subject to the conditions of manufacture of paper and paper- such sanctions or approvals, substances board. generally recognized as safe for use in Defoaming agents may be safely used food, substances generally recognized in the manufacture of paper and paper- as safe for use in paper and paperboard, board intended for use in packaging, and substances listed in this para- transporting, or holding food in accord- graph, subject to the limitations, if ance with the following prescribed con- any, prescribed. ditions: (1) Fatty triglycerides, and the fatty (a) The defoaming agents are pre- acids, alcohols, and dimers derived pared from one or more of the sub- therefrom: stances named in paragraph (d) of this Beef tallow. section, subject to any prescribed limi- Castor oil. tations. Coconut oil.

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Corn oil. Butoxy polyethylene polypropylene glycol Cottonseed oil. molecular weight 900–4,200. Fish oil. Butoxy-polyoxypropylene molecular weight Lard oil. 1,000–2,500. Linseed oil. Butylated hydroxyanisole. Mustardseed oil. Butylated hydroxytoluene. Palm oil. Calcium lignin sulfonate. Peanut oil. Capryl alcohol. Rapeseed oil. p-Chlorometacresol. Ricebran oil. Cyclohexanol. Soybean oil. Diacetyltartaric acid ester of tallow mono- Sperm oil. glyceride. Tall oil. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65–7), for use as a preservative at a (2) Fatty triglycerides, and marine level not to exceed 0.05 weight-percent of oils, and the fatty acids and alcohols the defoaming agent. derived therefrom (paragraph (d)(1) of Diethanolamine. this section) reacted with one or more Diethylene triamine. of the following, with or without dehy- Di-(2-ethylhexyl) phthalate. 2,6-Dimethyl heptanol-4 (nonyl alcohol). dration, to form chemicals of the cat- Dimethylpolysiloxane. egory indicated in parentheses: Di-tert-butyl hydroquinone. Aluminum hydroxide (soaps). Dodecylbenzene sulfonic acids. Ammonia (amides). Ethanol. Butanol (esters). 2-Ethylhexanol. Butoxy-polyoxypropylene, molecular weight Ethylenediamine tetraacetic acid tetra- 1,000–2,500 (esters). sodium salt. Butylene glycol (esters). Formaldehyde. Calcium hydroxide (soaps). Heavy oxo-fraction (a still-bottom product of Diethanolamine (amides). iso-octyl alcohol manufacture, of approxi- Diethylene glycol (esters). mate composition: Octyl alcohol 5 percent Ethylene glycol (esters). nonyl alcohol 10 percent, decyl and higher Ethylene oxide (esters and ethers). alcohols 35 percent, esters 45 percent, and Glycerin (mono- and diglycerides). soaps 5 percent). Hydrogen (hydrogenated compounds). 2-Heptadecenyl-4-methyl-4-hydroxymethyl-2- Hydrogen (amines). oxazoline. Isobutanol (esters). Hexylene glycol (2-methyl-2-4-pentanediol). 12-Hydroxystearic acid. Isopropanol (esters). Isobutanol. Magnesium hydroxide (soaps). Isopropanol. Methanol (esters). Isopropylamine salt of dodecylbenzene sul- Morpholine (soaps). fonic acid. Oxygen (air-blown oils). Kerosine. Pentaerythritol (esters). Lanolin. Polyoxyethylene, molecular weights 200, 300, Methanol. 400, 600, 700, 1,000, 1,540, 1,580, 1,760, 4,600 Methyl 12-hydroxystearate. (esters). Methyl taurine-oleic acid condensate, molec- Polyoxypropylene, molecular weight 200– ular weight 486. 2,000 (esters). a,a′-[Methylenebis[4-(1,1,3,3-tetramethylbu- Potassium hydroxide (soaps). tyl)-o-phenylene]]bis[omega-hydroxypoly Propanol (esters). (oxyethylene)] having 6–7.5 moles of ethyl- Propylene glycol (esters). ene oxide per hydroxyl group. Propylene oxide (esters). Mineral oil. Sodium hydroxide (soaps). Mono-, di-, and triisopropanolamine. Sorbitol (esters). Mono- and diisopropanolamine stearate. Sulfuric acid (sulfated and sulfonated com- Monobutyl ether of ethylene glycol. pounds). Monoethanolamine. Triethanolamine (amides and soaps). Morpholine. Triisopropanolamine (amides and soaps). Myristyl alcohol. Trimethylolethane (esters). Naphtha. Zinc hydroxide (soaps). b-Naphthol. (3) Miscellaneous: Nonylphenol. Odorless light petroleum hydrocarbons. Alcohols and ketone alcohols mixture (still- Oleyl alcohol. bottom product from C12-C18 alcohol manu- Petrolatum. facturing process). o-Phenylphenol. Amyl alcohol. Pine oil.

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Polybutene, hydrogenated; complying with Tridecyl alcohol. the identity prescribed under § 178.3740(b) of Triethanolamine. this chapter. Triethylene glycol di(2-ethyl hexanoate). Polyethylene. Tri-(2-ethylhexyl) phosphate. Polyethylene, oxidized (air-blown). Tristearyl phosphate. Polymer derived from N-vinyl pyrrolidone Wax, petroleum, Type I and Type II. and copolymers derived from the mixed Wax, petroleum (oxidized). alkyl (C12-C15, C16, C18, C20, and C22) methacrylate esters, butyl methacrylate (CAS Wax (montan). Reg. No. 97–88–1), isobutyl methacrylate [42 FR 14554, Mar. 15, 1977, as amended at 47 (CAS Reg. No. 97–86–9) and methyl meth- FR 17986, Apr. 27, 1982; 47 FR 46495, Oct. 19, acrylate (CAS Reg. No. 80–62–6); the com- 1982; 47 FR 56845, Dec. 21, 1982; 54 FR 24897, bined polymer contains no more than 5 June 12, 1989; 57 FR 31313, July 15, 1992; 61 FR weight percent of polymer units derived 14246, Apr. 1, 1996] from N-vinyl pyrrolidone and is present at a level not to exceed 7 parts per million by § 176.230 3,5-Dimethyl-1,3,5,2H- weight of the finished dry paper and paper- tetrahydrothiadiazine-2-thione. board fibers. Polyoxyethylene (4 mols) decyl phosphate. 3,5-Dimethyl-1,3,5,2H-tetrahydrothi- Polyoxyethylene (4 mols) di(2-ethyl hexano- adiazine-2-thione may safely be used as ate). a preservative in the manufacture and Polyoxyethylene (15 mols) ester of rosin. coating of paper and paperboard in- Polyoxyethylene (3–15 mols) tridecyl alcohol. tended for use in contact with food in Polyoxypropylene, molecular weight 200– accordance with the following pre- 2,000. Polyoxypropylene-polyoxethylene conden- scribed conditions: sate, minimum molecular weight 950. (a) It is used as follows: Polyoxypropylene-ethylene oxide condensate (1) In the manufacture of paper and of ethylene diamine, molecular weight paperboard as a preservative for sub- 1,700–3,800. stances added to the pulp suspension Polyvinyl pyrrolidone, molecular weight prior to the sheet-forming operation 40,000. Potassium distearyl phosphate. provided that the preservative is vola- Potassium pentachlorophenate. tilized by heat in the drying and fin- Potassium trichlorophenate. ishing of the paper and paperboard. Rosins and rosin derivatives identified in (2) As a preservative for coatings for § 175.105(c)(5) of this chapter. paper and paperboard, Provided, That Silica. the preservative is volatilized by heat Siloxanes and silicones, dimethyl, methylhydrogen, reaction products with poly- in the drying and finishing of the coat- ethylene-polypropylene glycol monoallyl ed paper or paperboard. ether (CAS Reg. No. 71965–38–3). (b) The quantity used shall not ex- Sodium alkyl (C9-C15) benzene-sulfonate. ceed the least amount reasonably re- Sodium dioctyl sulfosuccinate. quired to accomplish the intended Sodium distearyl phosphate. technical effect and shall not be in- Sodium lauryl sulfate. tended to nor, in fact, accomplish any Sodium lignin sulfonate. Sodium 2-mercaptobenzothiazole. physical or technical effect in the food Sodium naphthalenesulfonic acid (3 mols) itself. condensed with formaldehyde (2 mols). (c) The use of a preservative in any Sodium orthophenylphenate. substance or article subject to any reg- Sodium pentachlorophenate. ulation in parts 174, 175, 176, 177, 178 Sodium petroleum sulfonate, molecular and § 179.45 of this chapter must comply weight 440–450. with any specifications and limitations Sodium trichlorophenate. Stearyl alcohol. prescribed by such regulation for the a-[p-(1,1,3,3-Tetramethylbutyl) phenyl-, p- substance or article. nonylphenyl-, or p-dodecylphenyl]-omega- hydroxypoly(oxyethylene) produced by the § 176.250 Poly-1,4,7,10,13-pentaaza-15- condensation of 1 mole of p-alkylphenol hydroxyhexadecane. (alkyl group is 1,1,3,3-tetramethylbutyl, a Poly-1,4,7,10,13-pentaaza-15-hydrox- propylene trimer isomer, or a propylene yhexadecane may be safely used as a tetramer isomer) with an average of 1.5–15 moles of ethylene oxide. retention aid employed prior to the Tetrahydrofurfuryl alcohol. sheet-forming operation in the manu- Tributoxyethyl phosphate. facture of paper and paperboard in- Tributyl phosphate. tended for use in contact with food in

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an amount not to exceed that nec- lations promulgated under sections 406 essary to accomplish the intended and 409 of the act or (ii) has been used physical or technical effect and not to for shipping or handling any such sub- exceed 6 pounds per ton of finished stance. paper or paperboard. § 176.300 Slimicides. § 176.260 Pulp from reclaimed fiber. (a) Slimicides may be safely used in (a) Pulp from reclaimed fiber may be the manufacture of paper and paper- safely used as a component of articles board that contact food, in accordance used in producing, manufacturing, with the following prescribed condi- packing, processing, preparing, treat- tions: ing, packaging, transporting, or hold- (1) Slimicides are used as anti- ing food, subject to the provisions of microbial agents to control slime in paragraph (b) of this section. the manufacture of paper and paper- (b) Pulp from reclaimed fiber is pre- board. pared from the paper and paperboard (2) Subject to any prescribed limita- products described in paragraphs (b) (1) and (2) of this section, by repulping tions, slimicides are prepared from one with water to recover the fiber with or more of the slime-control substances the least possible amount of nonfibrous named in paragraph (c) of this section substances. to which may be added optional adju- (1) Industrial waste from the manu- vant substances as provided for under facture of paper and paperboard prod- paragraph (d) of this section. ucts excluding that which bears or con- (3) Slimicides are added to the proc- tains any poisonous or deleterious sub- ess water used in the production of stance which is retained in the recov- paper or paperboard, and the quantity ered pulp and that migrates to the added shall not exceed the amount nec- food, except as provided in regulations essary to accomplish the intended promulgated under sections 406 and 409 technical effect. of the Federal Food, Drug, and Cos- (b) To insure safe usage, the label or metic Act. labeling of slimicides shall bear ade- (2) Salvage from used paper and pa- quate directions for use. perboard excluding that which (i) bears (c) Slime-control substances per- or contains any poisonous or delete- mitted for use in the preparation of rious substance which is retained in slimicides include substances subject the recovered pulp and that migrates to prior sanction or approval for such to the food, except as provided in regu- use and the following:

List of substances Limitations

Acrolein. Alkenyl (C16-C18) dimethylethyl-ammonium bromide. n-Alkyl (C12-C18) dimethyl benzyl ammonium chloride. 1,2-Benzisothiazolin-3-one ...... At a level of 0.06 pound per ton of dry weight fiber. Bis(1,4-bromoacetoxy)-2-butene. 5,5-Bis(bromoacetoxymethyl) m-dioxane. 2,6-Bis(dimethylaminomethyl) cyclohexanone. 1,2-Bis(monobromoacetoxy) ethane [CA Reg. No. 3785–34–0] At a maximum level of 0.10 pound per ton of dry weight fiber. Bis(trichloromethyl)sulfone. 4-Bromoacetoxymethyl-m-dioxolane. 2-Bromo-4′-hydroxyacetophenone. 2-Bromo-2-nitropropane-1,3-diol (CAS Reg. No. 52–51–7) ...... At a maximum level of 0.6 pound per ton of dry weight fiber. b-Bromo-b-nitrostyrene ...... At a maximum level of 1 pound per ton of dry weight fiber. Chloroethylenebisthiocyanate. 5-Chloro-2 - methyl - 4 - isothiazolin-3-one calcium chloride At a level of 2.5 pounds per ton of dry weight fiber. and 2-methyl-4-isothiazolin-3-one calcium chloride mixture at a ratio of 3 parts to 1 part. Chlorinated levulinic acids. Chloromethyl butanethiolsulfonate. Cupric nitrate. n-Dialkyl (C12-C18) benzylmethylammonium chloride. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65–7) .. At a maximum level of 0.005% of dry weight fiber. 2,2-Dibromo-3-nitrilopropionamide ...... At a maximum level of 0.1 lb/ton of dry weight fiber. 2,3-Dibromopropionaldehyde. 4,5-dichloro-1, 2-dithiol-3-one (CAS Reg. No. 1192–52–5) ...... For use only at levels not to exceed 10 milligrams per kilogram in the pulp slurry.

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List of substances Limitations

1,3-Dihalo-5,5-dimethylhydantoin (where the dihalo (halogen) At a maximum level of 1.0 kilogram (kg) per 1,000 kg of dry may be bromine and/or chlorine) that may contain no more weight fiber. than 20 weight percent 1,3-dihalo-5-ethyl-5-methylhydantoin (where the dihalo (halogen) may be bromine and/or chlorine).. 4-(Diiodomethylsulfonyl) toluene (CAS Reg. No. 20018–09–01). At a maximum level of 0.2 pound per ton (100 grams/1,000 kilograms) of dry weight fiber. 3,5-Dimethyl 1,3,5,2H-tetrahydrothiadiazine-2-thione. Dipotassium and disodium ethylenebis(dithiocarba-mate). Disodium cyanodithioimidocarbonate. n-Dodecylguanidine hydrochloride ...... At a maximum level of 0.20 pound per ton of dry weight fiber. Glutaraldehyde (CAS Reg. No. 111-30-8). 2-(p-hydroxyphenyl) glyoxylohydroximoyl chloride (CAS Reg- At a level of 0.02 pound per ton of dry weight fiber. istry No. 34911–46–1). 2-Hydroxypropyl methanethiol sulfonate. 2-Mercaptobenzothiazole. Methylenebisbutanethiolsulfonate. Methylenebisthiocyanate. 2-Nitrobutyl bromoacetate [CA Reg. No. 32815–96–6] ...... At a maximum level of 0.15 pound per ton of dry weight fiber. N-[a-(Nitroethyl)benzyl] ethylenediamine. Potassium 2-mercaptobenzothiazole. Potassium N-hydroxymethyl-N-methyldithiocarba-mate. Potassium N-methyldithiocarbamate. Potassium pentachlorophenate. Potassium trichlorophenate. Silver fluoride ...... Limit of addition to process water not to exceed 0.024 pound, calculated as silver fluoride, per ton of paper produced. Silver nitrate. Sodium dimethyldithiocarbamate. Sodium 2-mercaptobenzothiazole. Sodium pentachlorophenate. Sodium trichlorophenate. 1,3,6,8-Tetraazatricyclo[6.2.1.13,6] dodecane. 3,3,4,4-Tetrachlorotetrahydrothiophene-1,1-dioxide. Tetrakis(hydroxymethyl)phosphonium sulfate (CAS Reg. No. Maximum use level of 84 mg/kg in the pulp slurry. The additive 55566–30–8). may also be added to water, which when introduced into the pulp slurry, results in a concentration in the pulp slurry not to exceed 84 mg/kg. 2-(Thiocyanomethylthio) benzothiazole. Vinylene bisthiocyanate.

(d) Adjuvant substances permitted to Monomethyl ethers of mono-, di-, and tri- be used in the preparation of slimicides propylene glycol. include substances generally recog- Nonylphenol reaction product with 9 to 12 nized as safe for use in food, substances molecules of ethylene oxide. generally recognized as safe for use in Octylphenol reaction product with 25 mol- paper and paperboard, substances per- ecules of propylene oxide and 40 molecules mitted to be used in paper and paper- of ethylene oxide. board by other regulations in this [42 FR 14554, Mar. 15, 1977, as amended at 42 chapter, and the following: FR 41854, Aug. 19, 1977; 44 FR 75627, Dec. 21, 1979; 46 FR 36129, July 14, 1981; 49 FR 5748, Acetone. Feb. 15, 1984; 51 FR 19059, May 27, 1986; 51 FR Butlylene oxide. 43734, Dec. 4, 1986; 54 FR 18103, Apr. 27, 1989; Dibutyl phthalate. 55 FR 31825, Aug. 6, 1990; 64 FR 46130, Aug. 24, Didecyl phthalate. 1999; 64 FR 69900, Dec. 15, 1999; 65 FR 40497, N,N-Dimethylformamide. June 30, 2000; 65 FR 70790, Nov. 28, 2000] Dodecyl phthalate. Ethanolamine. § 176.320 Sodium nitrate-urea complex. Ethylene glycol. Sodium nitrate-urea complex may be Ethylenediamine. safely used as a component of articles N-methyl-2-pyrrolidone (CAS Reg. No. 872– intended for use in producing, manu- 50–4). a,a′-[Methylenebis[4-(1,1,3,3-tetramethyl- facturing, packing, processing, pre- butyl)-o-phenylene]] bis[omega-hydroxypoly paring, treating, packaging, trans- (oxyethylene)] having 6–7.5 moles of ethyl- porting, or holding food, subject to the ene oxide per hydroxyl group. provisions of this section.

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(a) Sodium nitrate-urea complex is a 177.1211 Cross-linked polyacrylate copoly- clathrate of approximately two parts mers. urea and one part sodium nitrate. 177.1240 1,4-Cyclohexylene dimethylene (b) Sodium nitrate-urea complex con- terephthalate and 1,4-cyclohexylene dimethylene isophthalate copolymer. forming to the limitations prescribed 177.1310 Ethylene-acrylic acid copolymers. in paragraph (b)(1) of this section is 177.1312 Ethylene-carbon monoxide copoly- used as provided in paragraph (b)(2) of mers. this section. 177.1315 Ethylene-1,4-cyclohexylene (1) Limitations. (i) It is used as a plas- dimethylene terephthalate copolymers. ticizer in glassine and greaseproof 177.1320 Ethylene-ethyl acrylate copoly- paper. mers. (ii) The amount used does not exceed 177.1330 Ionomeric resins. that required to accomplish its in- 177.1340 Ethylene-methyl acrylate copolymer resins. tended technical effect or exceed 15 177.1345 Ethylene/1,3-phenylene oxyethylene percent by weight of the finished paper. isophthalate/terephthalate copolymer. (2) Conditions of use. The glassine and 177.1350 Ethylene-vinyl acetate copolymers. greaseproof papers are used for pack- 177.1360 Ethylene-vinyl acetate-vinyl alco- aging dry food or as the food-contact hol copolymers. surface for dry food. 177.1380 Fluorocarbon resins. 177.1390 Laminate structures for use at tem- § 176.350 Tamarind seed kernel pow- peratures of 250 °F and above. der. 177.1395 Laminate structures for use at temperatures between 120 °F and 250° F. Tamarind seed kernel powder may be 177.1400 Hydroxyethyl cellulose film, water- safely used as a component of articles insoluble. intended for use in producing, manu- 177.1420 Isobutylene polymers. facturing, packing, processing, pre- 177.1430 Isobutylene-butene copolymers. paring, treating, packaging, trans- 177.1440 4,4′-Isopropylidenediphenol- porting, or holding food, subject to the epichlorohydrin resins minimum molec- provisions of this section. ular weight 10,000. (a) Tamarind seed kernel powder is 177.1460 Melamine-formaldehyde resins in molded articles. the ground kernel of tamarind seed 177.1480 Nitrile rubber modified acrylo- (Tamarindus indica L.) after removal of nitrile-methyl acrylate copolymers. the seed coat. 177.1500 Nylon resins. (b) It is used in the manufacture of 177.1520 Olefin polymers. paper and paperboard. 177.1550 Perfluorocarbon resins. 177.1555 Polyarylate resins. 177.1556 Polyaryletherketone resins. PART 177—INDIRECT FOOD 177.1560 Polyarylsulfone resins. ADDITIVES: POLYMERS 177.1570 Poly-1-butene resins and butene/ ethylene copolymers. Subpart A [Reserved] 177.1580 Polycarbonate resins. 177.1585 Polyestercarbonate resins. Subpart B—Substances for Use as Basic 177.1590 Polyester elastomers. Components of Single and Repeated 177.1595 Polyetherimide resin. Use Food Contact Surfaces 177.1600 Polyethylene resins, carboxyl modified. Sec. 177.1610 Polyethylene, chlorinated. 177.1010 Acrylic and modified acrylic plas- 177.1615 Polyethylene, fluorinated. tics, semirigid and rigid. 177.1620 Polyethylene, oxidized. 177.1020 Acrylonitrile/butadiene/styrene co– 177.1630 Polyethylene phthalate polymers. polymer. 177.1632 Poly (phenyleneterephthalamide) 177.1030 Acrylonitrile/butadiene/styrene/ resins. methyl methacrylate copolymer. 177.1635 Poly(p-methylstyrene) and rubber- 177.1040 Acrylonitrile/styrene copolymer. modified poly(p-methylstyrene). 177.1050 Acrylonitrile/styrene copolymer 177.1637 Poly(oxy-1,2- modified with butadiene/styrene elas- ethanediyloxycarbonyl-2,6- tomer. naphthalenediylcarbonyl) resins. 177.1060 n-Alkylglutarimide/acrylic copoly- 177.1640 Polystyrene and rubber-modified mers. polystyrene. 177.1200 Cellophane. 177.1650 Polysulfide polymer-polyepoxy res- 177.1210 Closures with sealing gaskets for ins. food containers. 177.1655 Polysulfone resins.

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177.1660 Poly (tetramethylene FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, terephthalate). 2001, and 68 FR 15355, Mar. 31, 2003. 177.1670 Polyvinyl alcohol film. 177.1680 Polyurethane resins. 177.1810 Styrene block polymers. Subpart A [Reserved] 177.1820 Styrene-maleic anhydride copolymers. Subpart B—Substances for Use as 177.1830 Styrene-methyl methacrylate co- Basic Components of Single polymers. 177.1850 Textryls. and Repeated Use Food Con- 177.1900 Urea-formaldehyde resins in molded tact Surfaces articles. 177.1950 Vinyl chloride-ethylene copoly- § 177.1010 Acrylic and modified acrylic mers. plastics, semirigid and rigid. 177.1960 Vinyl chloride-hexene-1 copoly- Semirigid and rigid acrylic and modi- mers. 177.1970 Vinyl chloride-lauryl vinyl ether fied acrylic plastics may be safely used copolymers. as articles intended for use in contact 177.1980 Vinyl chloride-propylene copoly- with food, in accordance with the fol- mers. lowing prescribed conditions. The 177.1990 Vinylidene chloride/methyl acry- acrylic and modified acrylic polymers late copolymers. or plastics described in this section 177.2000 Vinylidene chloride/methyl acry- also may be safely used as components late/methyl methacrylate polymers. of articles intended for use in contact Subpart C—Substances for Use Only as with food. Components of Articles Intended for (a) The optional substances that may Repeated Use be used in the formulation of the semirigid and rigid acrylic and modi- 177.2210 Ethylene polymer, fied acrylic plastics, or in the formula- chlorosulfonated. tion of acrylic and modified acrylic 177.2250 Filters, microporous polymeric. components of articles, include sub- 177.2260 Filters, resin-bonded. 177.2280 4,4′-Isopropylidenediphenol- stances generally recognized as safe in epichlorohydrin thermosetting epoxy food, substances used in accordance resins. with a prior sanction or approval, sub- 177.2355 Mineral reinforced nylon resins. stances permitted for use in such plas- 177.2400 Perfluorocarbon cured elastomers. tics by regulations in parts 170 through 177.2410 Phenolic resins in molded articles. 189 of this chapter, and substances 177.2415 Poly(aryletherketone) resins. 177.2420 Polyester resins, cross-linked. identified in this paragraph. At least 50 177.2430 Polyether resins, chlorinated. weight-percent of the polymer content 177.2440 Polyethersulfone resins. of the acrylic and modified acrylic ma- 177.2450 Polyamide-imide resins. terials used as finished articles or as 177.2460 Poly(2,6-dimethyl-1,4-phenylene) components of articles shall consist of oxide resins. polymer units derived from one or 177.2465 Polymethylmethacrylate/poly(tri more of the acrylic or methacrylic methoxysilylpropyl) methacrylate copolymers. monomers listed in paragraph (a)(1) of 177.2470 Polyoxymethylene copolymer. this section. 177.2480 Polyoxymethylene homopolymer. (1) Homopolymers and copolymers of 177.2490 Polyphenylene sulfide resins. the following monomers: 177.2500 Polyphenylene sulfone resins. 177.2510 Polyvinylidene fluoride resins. n-Butyl acrylate. 177.2550 Reverse osmosis membranes. n-Butyl methacrylate. 177.2600 Rubber articles intended for re- Ethyl acrylate. peated use. 2-Ethylhexyl acrylate. 177.2710 Styrene-divinylbenzene resins, Ethyl methacrylate. cross-linked. Methyl acrylate. 177.2800 Textiles and textile fibers. Methyl methacrylate. 177.2910 Ultra-filtration membranes. (2) Copolymers produced by copolym- AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. erizing one or more of the monomers SOURCE: 42 FR 14572, Mar. 15, 1977, unless listed in paragraph (a)(1) of this section otherwise noted. with one or more of the following monomers: EDITORIAL NOTE: Nomenclature changes to part 177 appear at 61 FR 14482, Apr. 2, 1996, 66 Acrylonitrile.

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Methacrylonitrile. tion reactions, occur when they are a-Methylstyrene. mixed: Styrene. Vinyl chloride. Butadiene-acrylonitrile copolymers. Vinylidene chloride. Butadiene-acrylonitrile-styrene copolymers. Butadiene-acrylonitrile-styrene-methyl (3) Polymers identified in paragraphs methacrylic copolymers. (a)(1) and (2) of this section containing Butadiene-styrene copolymers. no more than 5 weight-percent of total Butyl rubber. polymer units derived by copolym- Natural rubber. erization with one or more of the Polybutadiene. monomers listed in paragraph (a)(3)(i) Poly (3-chloro-1,3-butadiene). and (ii) of this section. Monomers list- Polyester identified in § 175.300(b)(3)(vii) of ed in paragraph (a)(3)(ii) of this section this chapter. are limited to use only in plastic arti- Polyvinyl chloride. Vinyl chloride copolymers complying with cles intended for repeated use in con- § 177.1980. tact with food. Vinyl chloride-vinyl acetate copolymers. (i) List of minor monomers: (5) Antioxidants and stabilizers iden- Acrylamide. tified in § 175.300(b)(3)(xxx) of this chap- Acrylic acid ter and the following: 1,3-Butylene glycol dimethacrylate. 1,4-Butylene glycol dimethacrylate. Di-tert-butyl-p-cresol. Diethylene glycol dimethacrylate. 2-Hydroxy-4-methoxybenzophenone. Diproplylene glycol dimethacrylate. 2-Hydroxy-4-methoxy-2- Divinylbenzene. carboxybenzophenone. Ethylene glycol dimethacrylate. 3-Hydroxyphenyl benzoate. Itaconic acid. p-Methoxyphenol. Methacrylic acid. Methyl salicylate. N-Methylolacrylamide. Octadecyl 3,5-di-tert-butyl-4-hydroxyhydro- N-Methylolmethacrylamide. cinnamate (CAS Reg. No. 2082–79–3): For 4-Methyl-1,4-pentanediol dimethacrylate. use only: (1) At levels not exceeding 0.2 Propylene glycol dimethacrylate. percent by weight in semirigid and rigid Trivinylbenzene. acrylic and modified acrylic plastics, (ii) List of minor monomers limited where the finished articles contact foods to use only in plastic articles intended containing not more than 15 percent alco- for repeated use in contact with food: hol; and (2) at levels not exceeding 0.01 percent by weight in semirigid and rigid Allyl methacrylate [Chemical Abstracts acrylic and modified acrylic plastics in- Service Registry No. 96–05–9] tended for repeated food-contact use where tert-Butyl acrylate. the finished article may be used for foods tert-Butylaminoethyl methacrylate. containing more than 15 percent alcohol. sec-Butyl methacrylate. Phenyl salicylate. tert-Butyl methacrylate. Cyclohexyl methacrylate. (6) Release agents: Fatty acids de- Dimethylaminoethyl methacrylate. rived from animal and vegetable fats 2-Ethylhexyl methacrylate. and oils, and fatty alcohols derived Hydroxyethyl methacrylate. from such acids. Hydroxyethyl vinyl sulfide. (7) Surface active agent: Sodium Hydroxypropyl methacrylate. dodecylbenzenesulfonate. Isobornyl methacrylate. Isobutyl methacrylate. (8) Miscellaneous materials: Isopropyl acrylate. Di(2-ethylhexyl) phthalate, for use only as a Isopropyl methacrylate. flow promoter at a level not to exceed 3 Methacrylamide. weight-percent based on the monomers. Methacrylamidoethylene urea. Dimethyl phthalate. Methacryloxyacetamidoethylethylene urea. Oxalic acid, for use only as a polymerization Methacryloxyacetic acid. catalyst aid. n-Propyl methacrylate. Tetraethylenepentamine, for use only as a 3,5,5-Trimethylcyclohexyl methacrylate. catalyst activator at a level not to exceed (4) Polymers identified in paragraphs 0.5 weight-percent based on the monomers. (a)(1), (2), and (3) of this section are Toluene. mixed together and/or with the fol- Xylene. lowing polymers, provided that no (b) The semirigid and rigid acrylic chemical reactions, other than addi- and modified acrylic plastics, in the

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finished form in which they are to con- n-heptane shall be spectrophotometric tact food, when extracted with the sol- grade. Adequate precautions must be vent or solvents characterizing the taken to keep all solvents dust-free. type of food and under the conditions (4) Blank values on solvents. (i) Dupli- of time and temperature as determined cate determinations of residual solids from tables 1 and 2 of § 176.170(c) of this shall be run on samples of each solvent chapter, shall yield extractives not to that have been exposed to the tempera- exceed the following, when tested by ture-time conditions of the extraction the methods prescribed in paragraph test without the plastic sample. Sixty (c) of this section. The acrylic and milliliters of exposed solvent is modified acrylic polymers or plastics pipetted into a clean, weighed plat- intended to be used as components of inum dish, evaporated to 2–5 milliliters articles also shall yield extractives not on a nonsparking, low-temperature hot to exceed the following limitations plate and dried in 212 °F oven for 30 when prepared as strips as described in minutes. The residue for each solvent paragraph (c)(2) of this section: shall be determined by weight and the (1) Total nonvolatile extractives not average residue weight used as the to exceed 0.3 milligram per square inch blank value in the total solids deter- of surface tested. mination set out in paragraph (c)(6) of (2) Potassium permanganate oxidiz- this section. The residue for an acceptable distilled water and 8 and 50 per- able solvent sample shall not exceed 0.5 cent alcohol extractives not to exceed milligram per 60 milliliters. an absorbance of 0.15. (ii) For acceptability in the ultra- (3) Ultraviolet-absorbing distilled violet absorbers test, a sample of each water and 8 and 50 percent alcohol ex- solvent shall be scanned in an ultra- tractives not to exceed an absorbance violet spectrophotometer in 5-centi- of 0.30. meter silica spectrophotometric ab- (4) Ultraviolet-absorbing n-heptane sorption cells. The absorbance of the extractives not to exceed an absorb- distilled water when measured versus ance of 0.10. air in the reference cell shall not ex- (c) Analytical methods—(1) Selection of ceed 0.03 at any point in the wave- extractability conditions. These are to be length region of 245 to 310 mµ. The ab- chosen as provided in § 176.170(c) of this sorbance of the 8 percent alcohol when chapter. measured versus distilled water in the (2) Preparation of samples. Sufficient reference cell shall not exceed 0.01 at samples to allow duplicates of all ap- any point in the wavelength region of plicable tests shall be cut from the ar- 245 to 310 mµ. The absorbance of the 50 ticles or formed from the plastic com- percent alcohol when measured versus position under tests, as strips about 2.5 distilled water in the reference cell inches by about 0.85-inch wide by about shall not exceed 0.05 at any point in the 0.125-inch thick. The total exposed sur- wavelength region of 245 to 310 mµ. The face should be 5 square inches ±0.5- absorbance of the heptane when meas- square inch. The samples, after prepa- ured versus distilled water in the ref- ration, shall be washed with a clean erence cell shall not exceed 0.15 at 245, brush under hot tapwater, rinsed under 0.09 at 260, 0.04 at 270, and 0.02 at any running hot tapwater (140 °F min- point in the wavelength region of 280 to imum), rinsed with distilled water, and 310 mµ. air-dried in a dust-free area or in a des- (iii) Duplicate ultraviolet blank de- iccator. terminations shall be run on samples of (3) Preparation of solvents. The water each solvent that has been exposed to used shall be double-distilled water, the temperature-time conditions of the prepared in a still using a block tin extraction test without the plastic condenser. The 8 and 50 percent (by vol- sample. An aliquot of the exposed sol- ume) alcohol solvents shall be prepared vent shall be measured versus the un- from ethyl alcohol meeting the speci- exposed solvent in the reference cell. fications of the United States Pharma- The average difference in the copeia XX and diluted with double-dis- absorbances at any wavelength in the tilled water that has been prepared in a region of 245 to 310 mµ shall be used as still using a tin block condenser. The a blank correction for the ultraviolet

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absorbers measured at the same wave- test tube. Pour the contents of the test length according to paragraph (c)(8)(ii) tube into a clean, weighed platinum of this section. dish. Wash the tube with 5 milliliters (iv) The acceptability of the solvents of the appropriate solvent and add the for use in the permanganate test shall solvent to the platinum dish. Evapo- be determined by preparing duplicate rate the solvent to 2–5 milliliters on a permanganate test blanks according to nonsparking, low-temperature paragraph (c)(7)(iv) of this section. For hotplate. Complete the evaporation in this test, the directions referring to a 212 °F oven for 30 minutes. Cool the the sample extract shall be dis- dish in a desiccator for 30 minutes and regarded. The blanks shall be scanned weigh to the nearest 0.1 milligram. Cal- in 5-centimeter silica culate the total nonvolatile extractives spectrophotometric cells in the spec- as follows: trophotometer versus the appropriate solvent as reference. The absorbance in eb− Milligrams extractives = distilled water in the wavelength re- per square inch gion of 544 to 552 mµ should be 1.16 but s must not be less than 1.05 nor more Extractives in parts eb than 1.25. The absorbance in the 8 and =×100 50 percent alcohol must not be less per million than 0.85 nor more than 1.15. s (v) Duplicate permanganate test de- where: terminations shall be run on samples of e=Total increase in weight of the dish, in distilled water and 8 and 50 percent al- milligrams. cohol solvents that have been exposed b=Blank value of the solvent in milligrams, to the temperature-time conditions of as determined in paragraph (c)(4)(i) of this the extraction test without the plastic section. sample. The procedure shall be as de- s=Total surface of the plastic sample in square inches. scribed in paragraph (c)(7)(iv) of this section, except that the appropriate ex- (7) Determination of potassium per- posed solvent shall be substituted manganate oxidizable extractives. (i) Pi- where the directions call for sample ex- pette 25 milliliters of distilled water tract. The average difference in the into a clean 125-milliliter Erlenmeyer absorbances in the region of 544 to 552 flask that has been rinsed several mµ shall be used as a blank correction times with aliquots of distilled water. for the determination of permanganate This is the blank. Prepare a distilled oxidizable extractives according to water solution containing 1.0 part per paragraph (c)(7)(iv) of this section. million of p-methoxyphenol (melting (5) Extraction procedure. For each ex- point 54–56 °C, Eastman grade or equiv- traction, place a plastic sample in a alent). Pipette 25 milliliters of this p- clean 25 millimeters × 200 millimeters methoxyphenol solution into a rinsed hard-glass test tube and add solvent Erlenmeyer flask. Pipette exactly 3.0 equal to 10 milliliters of solvent per milliliters of 154 parts per million square inch of plastic surface. This aqueous potassium permanganate solu- amount will be between 45 milliliters tion into the p-methoxyphenol and ex- and 55 milliliters. The solvent must be actly 3.0 milliliters into the blank, in preequilibrated to the temperature of that order. Swirl both flasks to mix the the extraction test. Close the test tube contents and then transfer aliquots with a ground-glass stopper and expose from each flask into matched 5-centi- to the specified temperature for the meter spectrophotometric absorption specified time. Cool the tube and con- cells. The cells are placed in the spec- tents to room temperature if nec- trophotometer cell compartment with essary. the p-methoxyphenol solution in the (6) Determination of total nonvolatile reference beam. Spectrophotometric extractives. Remove the plastic strip measurement is conducted as in para- from the solvent with a pair of clean graph (c)(7)(iv) of this section. The ab- forceps and wash the strip with 5 milli- sorbance reading in the region 544–552 liters of the appropriate solvent, add- mµ should be 0.24 but must be not less ing the washings to the contents of the than 0.12 nor more than 0.36. This test

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shall be run in duplicate. For the pur- extracts according to paragraph pose of ascertaining compliance with (c)(7)(iv) of this section shall be multi- the limitations in paragraph (b)(2) of plied by a correction factor, calculated this section, the absorbance measure- as follows: ments obtained on the distilled water

024. = Correction factor for water extracts. Average of duplicate ρ -methoxyphenol absorbance determinations according to this paragraph (c)(7)(i) of this section

(ii) The procedure in paragraph ascertaining compliance with the limi- (c)(7)(i) of this section is repeated ex- tations prescribed in paragraph (b)(2) of cept that, in this instance, the solvent this section, the absorbance measure- shall be 8 percent alcohol. The absorb- ments obtained on the 8 percent alco- ance in the region 544–552 mµ should be hol extracts according to paragraph 0.26 but must be not less than 0.13 nor (c)(7)(iv) of this section shall be multi- more than 0.39. This test shall be run in plied by a correction factor, calculated duplicate. For the purpose of as follows:

026. = Correction factor for aqueous Average of duplicate ρ -methoxyphenol 8 percent alcohol extracts. absorbance determination according to this paragraph (c)(7)(ii) of this section

(iii) The procedure in paragraph ascertaining compliance with the limi- (c)(7)(i) of this section is repeated ex- tations prescribed in paragraph (b)(2) of cept that, in this instance, the solvent this section, the absorbance measure- shall be 50 percent alcohol. The absorb- ments obtained on the 50 percent alco- ance in the region 544–552 mµ should be hol extracts according to paragraph 0.25 but must be not less than 0.12 nor (c)(7)(iv) of this section shall be multi- more than 0.38. This test shall be run in plied by a correction factor, calculated duplicate. For the purpose of as follows:

025. = Correction factor for 50 percent Average of duplicate ρ -methoxyphenol aqueous alcohol extracts. absorbance determinations according to paragraph (c)(7)(ii) of this section

(iv) Water and 8 and 50 percent alcohol tract that has been exposed under the extracts. Pipette 25 milliliters of the ap- conditions specified in paragraph (c)(5) propriate solvent into a clean, 125-mil- of this section. Pipette exactly 3.0 milliliter Erlenmeyer flask that has been liliters of 154 parts per million aqueous rinsed several times with aliquots of potassium permanganate solution into the same solvent. This is the blank. the sample and exactly 3.0 milliliters Into another similarly rinsed flask, pi- into the blank, in that order. Before pette 25 milliliters of the sample ex-

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use, the potassium permanganate solu- and (iii) of this section. This test shall tion shall be checked as in paragraph be run in duplicate and the two results (c)(7)(i) of this section. Both flasks are averaged. swirled to mix the contents, and then (8) Determination of ultraviolet-absorb- aliquots from each flask are trans- ing extractives. (i) A distilled water so- ferred to matched 5-centimeter lution containing 1.0 part per million spectrophotometric absorption cells. of p-methoxyphenol (melting point 54 Both cells are placed in the spectro- °C–56 °C. Eastman grade or equivalent) photometer cell compartment with the shall be scanned in the region 360 to 220 sample solution in the reference beam. mµ in 5-centimeter silica spectrophoto- The spectrophotometer is adjusted for metric absorption cells versus a dis- 0 and 100 percent transmittance at 700 tilled water reference. The absorbance mµ. The spectrum is scanned on the ab- at the wavelength of maximum absorb- sorbance scale from 700 mµ to 500 mµ in ance (should be about 285 mµ) is about such a way that the region 544 mµ to 0.11 but must be not less than 0.08 nor 552 mµ is scanned within 5 minutes to more than 0.14. This test shall be run in 10 minutes of the time that permanga- duplicate. For the purpose of nate was added to the solutions. The ascertaining compliance with the limi- height of the absorbance peak shall be tations prescribed in paragraph (b) (3) measured, corrected for the blank as and (4) of this section, the absorbance determined in paragraph (c)(4)(v) of obtained on the extracts according to this section, and multiplied by the ap- paragraph (c)(8)(ii) of this section shall propriate correction factor determined be multiplied by a correction factor, according to paragraph (c)(7) (i), (ii), calculated as follows:

011. = Correction factor for ultraviolet Average of duplicate ρ -methoxyphenol absorbers test. absorbance determinations according to this paragraph (c)(8)(i) of this section

(ii) An aliquot of the extract that has the provisions of § 180.22 of this chap- been exposed under the conditions ter. specified in paragraph (c)(5) of this sec- (f) The acrylic and modified acrylic tion is scanned in the wavelength re- polymers identified in and complying gion 360 to 220 mµ versus the appro- with this section, when used as compo- priate solvent reference in matched 5- nents of the food-contact surface of an centimeter silica spectrophotometric article that is the subject of a regula- absorption cells. The height of any ab- tion in this part and in parts 174, 175, sorption peak shall be measured, cor- 176, and 178 of this chapter, shall com- rected for the blank as determined in ply with any specifications and limita- paragraph (c)(4)(iii) of this section, and tions prescribed by such regulation for multiplied by the correction factor de- the article in the finished form in which it is to contact food. termined according to paragraph (c)(8)(i) of this section. [42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. (d) In accordance with current good 28, 1977, as amended at 43 FR 54927, Nov. 24, manufacturing practice, finished 1978; 45 FR 67320, Oct. 10, 1980; 46 FR 46796, semirigid and rigid acrylic and modi- Sept. 22, 1981; 49 FR 10108, Mar. 19, 1984; 49 FR 13139, Apr. 3, 1984; 50 FR 31045, July 24, 1985] fied acrylic plastics, and articles containing these polymers, intended for § 177.1020 Acrylonitrile/butadiene/sty- repeated use in contact with food shall rene co-polymer. be thoroughly cleansed prior to their Acrylonitrile/butadiene/styrene co- first use in contact with food. polymer identified in this section may (e) Acrylonitrile copolymers identi- be safely used as an article or compo- fied in this section shall comply with nent of articles intended for use with

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all foods, except those containing alco- termination of Residual Acrylonitrile hol, under conditions of use E, F, and G and Styrene Monomers-Gas described in table 2 of § 176.170(c) of this Chromatographic Internal Standard chapter. Method,’’ which is incorporated by ref- (a) Identity. For the purpose of this erence. Copies are available from the section, the acrylonitrile/butadiene/ Center for Food Safety and Applied Nu- styrene copolymer consists of: trition (HFS–200), Food and Drug Ad- (1) Eighty-four to eighty-nine parts ministration, 5100 Paint Branch Pkwy., by weight of a matrix polymer con- College Park, MD 20740, or available for taining 73 to 78 parts by weight of acry- inspection at the Office of the Federal lonitrile and 22 to 27 parts by weight of Register, 800 North Capitol Street, styrene; and NW., suite 700, Washington, DC 20408. (2) Eleven to sixteen parts by weight (d) Extractive limitations. (1) Total of a grafted rubber consisting of (i) 8 to nonvolatile extractives not to exceed 13 parts of butadiene/styrene elastomer 0.0005 milligram per square inch sur- containing 72 to 77 parts by weight of face area when the finished food con- butadiene and 23 to 28 parts by weight tact article is exposed to distilled of styrene and (ii) 3 to 8 parts by water, 3 percent acetic acid, or n- weight of a graft polymer having the heptane for 8 days at 120 °F. same composition range as the matrix (2) The finished food-contact article polymer. shall yield not more than 0.0015 milli- (b) Adjuvants. The copolymer identi- gram per square inch of acrylonitrile fied in paragraph (a) of this section monomer when exposed to distilled may contain adjuvant substances re- water and 3 percent acetic acid at 150 quired in its production. Such adju- °F for 15 days when analyzed by a po- vants may include substances gen- larographic method titled ‘‘Extracted erally recognized as safe in food, sub- Acrylonitrile by Differential Pulse Po- stances used in accordance with prior larography,’’ which is incorporated by sanction, substances permitted in this reference. Copies are available from part, and the following: the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Substance Limitations Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 2-Mercapto- ethanol ...... The finished copolymer shall contain not more than 100 available for inspection at the Office of ppm 2-mercaptoethanol ac- the Federal Register, 800 North Capitol rylonitrile adduct as deter- Street, NW., suite 700, Washington, DC mined by a method titled ‘‘Analysis of Cycopac 20408. Resin for Residual b-(2- (e) Acrylonitrile copolymers identi- Hydroxyethylmercapto) pro- fied in this section shall comply with pionitrile,’’ which is incor- the provisions of § 180.22 of this chap- porated by reference. Cop- ies are available from the ter. Bureau of Foods (HFS– (f) Acrylonitrile copolymers identi- 200), Food and Drug Ad- fied in this section are not authorized ministration, 5100 Paint to be used to fabricate beverage con- Branch Pkwy., College Park, MD 20740, or avail- tainers. able for inspection at the Office of the Federal Reg- [42 FR 14572, Mar. 15, 1977, as amended at 42 ister, 800 North Capitol FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, Street, NW., suite 700, 1982; 54 FR 24897, June 12, 1989] Washington, DC 20408. § 177.1030 Acrylonitrile/butadiene/sty- (c) Specifications. (1) Nitrogen content rene/methyl methacrylate copoly- of the copolymer is in the range of 16 mer. to 18.5 percent as determined by Micro- Acrylonitrile/butadiene/styrene/ Kjeldahl analysis. methyl methacrylate copolymer iden- (2) Residual acrylonitrile monomer tified in this section may be safely content of the finished copolymer arti- used as an article or component of articles is not more than 11 parts per mil- cles intended for use with food identi- lion as determined by a gas fied in table 1 of § 176.170(c) of this chromatographic method titled ‘‘De- chapter as Type I, II, III, IVA, IVB, V,

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VIB, (except bottles intended to hold cles is not more than 11 parts per mil- carbonated beverages), VIIA, VIIB, VIII lion as determined by a gas and IX, under conditions of use C, D, E, chromatographic method titled ‘‘De- F, and G described in table 2 of termination of Residual Acrylonitrile § 176.170(c) of this chapter with a high and Styrene Monomers-Gas temperature limitation of 190 °F. Chromatographic Internal Standard (a) Identity. For the purpose of this Method,’’ which is incorporated by ref- section, acrylonitrile/butadiene/sty- erence. Copies are available from the rene/methyl methacrylate copolymer Center for Food Safety and Applied Nu- consists of: (1) 73 to 79 parts by weight trition (HFS–200), Food and Drug Ad- of a matrix polymer containing 64 to 69 ministration, 5100 Paint Branch Pkwy., parts by weight of acrylonitrile, 25 to College Park, MD 20740, or available for 30 parts by weight of styrene and 4 to inspection at the Office of the Federal 6 parts by weight of methyl methacry- Register, 800 North Capitol Street, late; and (2) 21 to 27 parts by weight of NW., suite 700, Washington, DC 20408. a grafted rubber consisting of (i) 16 to (d) Extractive limitations. (1) Total 20 parts of butadiene/styrene/elastomer nonvolatile extractives not to exceed containing 72 to 77 parts by weight of 0.0005 milligram per square inch sur- butadiene and 23 to 28 parts by weight face area of the food-contact article of styrene and (ii) 5 to 10 parts by when exposed to distilled water, 3 per- weight of a graft polymer having the cent acetic acid, 50 percent ethanol, same composition range as the matrix and n-heptane for 10 days at 120 °F. polymer. (2) The finished food-contact article (b) Adjuvants. The copolymer identi- shall yield not more than 0.0025 milli- fied in paragraph (a) of this section gram per square inch of acrylonitrile may contain adjuvant substances re- monomer when exposed to distilled quired in its production. Such adju- water, 3 percent acetic acid and n- vants may include substances gen- heptane at 190 °F for 2 hours, cooled to erally recognized as safe in food, sub- 120 °F (80 to 90 minutes) and main- stances used in accordance with prior tained at 120 °F for 10 days when ana- sanction, substances permitted under lyzed by a polarographic method titled applicable regulations in this part, and ‘‘Extracted Acrylonitrile by Differen- the following: tial Pulse Polarography,’’ which is incorporated by reference. Copies are Substances Limitations available from the Center for Food 2–Mercaptoethanol ...... The finished copolymer shall Safety and Applied Nutrition (HFS– contain not more than 800 200), Food and Drug Administration, ppm 2–mercaptoethanol 5100 Paint Branch Pkwy., College Park, acrylonitrile adduct as determined by a method titled MD 20740, or available for inspection at ‘‘Analysis of Cycopac the Office of the Federal Register, 800 Resin for Residual b–(2– North Capitol Street, NW., suite 700, Hydroxyethylmercapto) propionitrile,’’ which is incor- Washington, DC 20408. porated by reference. Cop- (e) Acrylonitrile copolymers identi- ies are available from the fied in this section shall comply with Bureau of Foods (HFS– 200), Food and Drug Ad- the provisions of § 180.22 of this chap- ministration, 5100 Paint ter. Branch Pkwy., College (f) Acrylonitrile copolymers identi- Park, MD 20740, or available for inspection at the fied in this section are not authorized Office of the Federal Reg- to be used to fabricate beverage con- ister, 800 North Capitol tainers. Street, NW., suite 700, Washington, DC 20408. [42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, (c) Specifications. (1) Nitrogen content 1982; 54 FR 24898, June 12, 1989] of the copolymer is in the range of 13.0 to 16.0 percent as determined by Micro- § 177.1040 Acrylonitrile/styrene copoly- Kjeldahl analysis. mer. (2) Residual acrylonitrile monomer Acrylonitrile/styrene copolymers content of the finished copolymer arti- identified in this section may be safely

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used as a component of packaging ma- erally recognized as safe in food, sub- terials subject to the provisions of this stances used in accordance with prior section. sanction, substances permitted under (a) Identity. For the purposes of this applicable regulations in this part, and section acrylonitrile/styrene copoly- those authorized in paragraph (b)(2) of mers are basic copolymers meeting the this section. specifications prescribed in paragraph (2) The optional adjuvants for the ac- (c) of this section. rylonitrile/styrene copolymer identi- (b) Adjuvants. (1) The copolymers fied in paragraphs (c) (1) and (3) of this identified in paragraph (c) of this section may contain adjuvant substances section are as follows: required in their production, with the Substances Limitation exception that they shall not contain mercaptans or other substances which Condensation polymer of toluene 0.15 pct maximum. form reversible complexes with acryl- sulfonamide and formaldehyde. onitrile monomer. Permissible adjuvants may include substances gen- (c) Specifications.

Maximum residual acrylonitrile mon- Nitrogen con- Maximum extractable fractions at Conformance with Acrylonitrile/styrene copolymers omer content tent of co- specified temperatures and times certain specifications of finished polymer article

1. Acrylonitrile/styrene copolymer 80 ppm1 ...... 17.4 to 19 Total nonvolatile extractives not to Minimum number av- consisting of the copolymer pro- pct. exceed 0.01 mg/in 2 surface erage molecular duced by polymerization of 66– area of the food contact article weight is 30,000.1 72 parts by weight of acrylo- when exposed to distilled water nitrile and 28–34 parts by weight and 3 pct acetic acid for 10 d at of styrene; for use with food of 66 °C (150 °F). Type VI–B identified in table 1 of The extracted copolymer shall not § 176.170(c) of this chapter exceed 0.001 mg/in 2 surface under conditions of use C, D, E, area of the food contact article F, G described in table 2 of when exposed to distilled water § 176.170(c) of this chapter. and 3 pct acetic acid for 10 d at 66 °C (150 °F) 1. 2. Acrylonitrile/styrene copolymer 50 ppm1 ...... 12.2 to 17.2 Extracted copolymer not to exceed Minimum 10 pct solu- consisting of the copolymer pro- pct. 2.0 ppm in aqueous extract or n- tion viscosity at 25 duced by polymerization of 45– heptane extract obtained when °C (77 °F) is 10cP.1 65 parts by weight of acrylo- 100 g sample of the basic co- nitrile and 35–55 parts by weigth polymer in the form of particles of styrene; for use with food of of a size that will pass through a Types, I, II, III, IV, V, VI (except U.S. Standard Sieve No. 6 and bottles), VII, VIII, and IX identi- that will be held on a U.S. fied in table 1 of § 176.170(c) of Standard Sieve No. 10 is ex- this chapter under conditions B tracted with 250 mil of deionized (not to exceed 93 °C (200 °F)), water or reagent grade n- C, D, E, F, G described in table heptane at reflux temperature 2 of § 176.170(c) of this chapter. for 2 h.1 3. Acrylonitrile/styrene copolymer 0.10 ppm 17.4 to 19 Total nonvolatile extractives not to Maximum carbon di- consisting of the copolymer pro- (calculated pct. exceed 0.01 mg/in 2 surface oxide permeability duced by polymerization of 66– on the area of the food contact article at 23 °C (73 °F) for 72 parts by weight of acrylo- basis of when exposed to distilled water the finished article nitrile and 28–34 parts by weight the weight and 3 pct acetic acid for 10 d at is 0.04 barrer.3 of styrene; for use with food of of the ac- 66 °C (150 °F). Types VI–A and VI–B identified rylonitrile The extracted copolymer shall not in table 1 of § 176.170(c) of this copolymer exceed 0.001 mg/in 2 surface chapter under conditions of use resin in the area of the food contact article C, D, E, F, G described in table finished ar- when exposed to distilled water 2 of § 176.170(c) of this chapter. ticles).2 and 3 pct acetic acid for 10 d at 66 °C (150 °F).1.

1 Use methods for determination of residual acrylonitrile monomer content, maximum extractable fraction, number average molecular weight, and solution viscosity, titled: ‘‘Determination of Residual Acrylonitrile and Styrene Monomers-Gas Chromatographic Internal Standard Method’’; ‘‘Infrared Spectrophotometric Determination of Polymer Extracted from Barex 210 Resin Pellets’’; ‘‘Procedure for the Determination of Molecular Weights of Acrylonitrile/Styrene Copolymers,’’ and ‘‘Analytical Method for 10% Solution Viscosity of Tyril,’’ which are incorproated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

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2 As determined by the method titled ‘‘Headspace Sampling and Gas-Solid Chromatographic Determination of Residual Acrylo- nitrile in Acrylonitrile Copolyemr Solutions,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. 3 As determined on appropriately shaped test samples of the article or acrylonitrile copolymer layer in a multilayer construction by ASTM method D–1434–82, ‘‘Standard Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), 5100 Paint Branch Pkwy., College Park, MD 20740, and the American Society for Testing Materials, 1916 Race Street, Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

(d) Interim listing. Acrylonitrile co- prior sanction, substances permitted polymers identified in this section under applicable regulations in this shall comply with the provisions of part, and the following: § 180.22 of this chapter. (e) Acrylonitrile copolymer identified Substances Limitations in this section may be used to fabricate n-Dodecylmercaptan ...... The finished copolymer shall beverage containers only if they com- contain not more than 500 ply with the specifications of item 3 in parts per million (ppm) dodecylmercaptan as paragraph (c) of this section. dodecylmercapto- propionitrile as determined [42 FR 14572, Mar. 15, 1977, as amended at 42 by the method titled, ‘‘De- FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, termination of b-Dodecyl- 1982; 49 FR 36643, Sept. 19, 1984; 52 FR 33803, mercaptopropionitrile in Sept. 8, 1987] NR–16 Polymer,’’ which is incorporated by reference. § 177.1050 Acrylonitrile/styrene copoly- Copies are available from the Center for Food Safety mer modified with butadiene/sty- and Applied Nutrition rene elastomer. (HFS–200), Food and Drug Acrylonitrile/styrene copolymer Administration, 5100 Paint Branch Pkwy., College modified with butadiene/styrene elas- Park, MD 20740, or avail- tomer identified in this section may be able for inspection at the safely used as a component of bottles Office of the Federal Reg- ister, 800 North Capitol intended for use with foods identified Street, NW., suite 700, in table I of § 176.170(c) of this chapter Washington, DC 20408. as Type VI–B under conditions for use E, F, or G described in table 2 of (c) Specifications. (1) Nitrogen content § 176.170(c) of this chapter. of the modified copolymer is in the (a) Identity. For the purpose of this range of 17.7–19.8 percent. section, acrylonitrile/styrene copoly- (2) Intrinsic viscosity of the matrix mer modified with butadiene/styrene copolymer in butyrolactone is not less elastomer consists of a blend of: than 0.5 deciliter/gram at 35 °C, as de- (1) 82–88 parts by weight of a matrix termined by the method titled ‘‘Molec- copolymer produced by polymerization ular Weight of Matrix Copolymer by of 77–82 parts by weight of acrylonitrile Solution Viscosity,’’ which is incor- and 18–23 parts of styrene; and porated by reference. Copies are avail- (2) 12–18 parts by weight of a grafted able from the Center for Food Safety rubber consisting of (i) 8–12 parts of bu- and Applied Nutrition (HFS–200), Food tadiene/styrene elastomer containing and Drug Administration, 5100 Paint 77–82 parts by weight of butadiene and Branch Pkwy., College Park, MD 20740, 18–23 parts by weight of styrene and (ii) or available for inspection at the Office 4–6 parts by weight of a graft copoly- of the Federal Register, 800 North Cap- mer consisting of 70–77 parts by weight itol Street, NW., suite 700, Washington, of acrylonitrile and 23–30 parts by DC 20408. weight of styrene. (3) Residual acrylonitrile monomer (b) Adjuvants. The modified copoly- content of the modified copolymer ar- mer identified in paragraph (a) of this ticles is not more than 11 ppm as deter- section may contain adjuvant sub- mined by a gas chromatographic meth- stances required in its production. od titled ‘‘Determination of Residual Such adjuvants may include substances Acrylonitrile and Styrene Monomers- generally recognized as safe in food, Gas Chromatographic Internal Stand- substances used in accordance with ard Method,’’ which is incorporated by

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reference. Copies are available from and cooled to room temperature. A the Center for Food Safety and Applied sample of the extracting solvent is Nutrition (HFS–200), Food and Drug then withdrawn and analyzed for acry- Administration, 5100 Paint Branch lonitrile monomer by a gas Pkwy., College Park, MD 20740, or chromatographic method titled ‘‘Gas- available for inspection at the Office of Solid Chromatographic Procedure for the Federal Register, 800 North Capitol Determining Acrylonitrile Monomer in Street, NW., suite 700, Washington, DC Acrylonitrile-Containing Polymers and 20408. Food Simulating Solvents,’’ which is (d) Extractives limitations. The fol- incorporated by reference. Copies, are lowing extractives limitations are de- available from the Center for Food termined by an infrared spectrophoto- Safety and Applied Nutrition (HFS– metric method titled ‘‘Infrared 200), Food and Drug Administration, Spectrophotometric Determination of 5100 Paint Branch Pkwy., College Park, Polymer Extracted from Borex 210 MD 20740, or available for inspection at Resin Pellets,’’ which is incorporated the Office of the Federal Register, 800 by reference. Copies are available from North Capitol Street, NW., suite 700, the Center for Food Safety and Applied Washington, DC 20408. Nutrition (HFS–200), Food and Drug (f) Acrylonitrile copolymers identi- Administration, 5100 Paint Branch fied in this section shall comply with Pkwy., College Park, MD 20740, or the provisions of § 180.22 of this chap- available for inspection at the Office of ter. the Federal Register, 800 North Capitol (g) Acrylonitrile copolymers identi- Street, NW., suite 700, Washington, DC fied in this section are not authorized 20408, and are applicable to the modi- to be used to fabricate beverage con- fied copolymers in the form of particles tainers. of a size that will pass through a U.S. Standard Sieve No. 6 and that will be [42 FR 14572, Mar. 15, 1977, as amended at 42 held on a U.S. Standard Sieve No. 10: FR 48544, Sept. 23, 1977; 47 FR 11841, Mar. 19, (1) The extracted copolymer shall not 1982; 47 FR 16775, Apr. 20, 1982; 54 FR 24898, exceed 2.0 ppm in aqueous extract ob- June 12, 1989] tained when a 100-gram sample of co- § 177.1060 n-Alkylglutarimide/acrylic polymer is extracted with 250 milli- copolymers. liters of freshly distilled water at reflux temperature for 2 hours. n-Alkylglutarimide/acrylic copoly- (2) The extracted copolymer shall not mers identified in this section may be exceed 0.5 ppm in n-heptane when a 100- safely used as articles or components gram sample of the basic copol-ymer is of articles intended for use in contact extracted with 250 milliliters spectral with food subject to provisions of this grade n-heptane at reflux temperature section and part 174 of this chapter. for 2 hours. (a) Identity. For the purpose of this (e) Accelerated extraction end test. The section, n-alkylglutarimide/acrylic co- modified copolymer shall yield acrylo- polymers are copolymers obtained by nitrile monomer not in excess of 0.4 reaction of substances permitted by ppm when tested as follows: § 177.1010(a) (1), (2), and (3) with the fol- (1) The modified copolymer shall be lowing substance: Monomethylamine in the form of eight strips 1⁄2 inch by 4 (CAS Reg. No. 74–89–5), to form n- inches by .03 inch. methylglutarimide/acrylic copolymers. (2) The modified copolymer strips (b) Adjuvants. The copolymers identi- shall be immersed in 225 milliliters of 3 fied in paragraph (a) of this section percent acetic acid in a Pyrex glass may contain adjuvant substances re- pressure bottle. quired in their production. The op- (3) The pyrex glass pressure bottle is tional adjuvant substances required in then sealed and heated to 150 °F in ei- the production of the basic polymer ther a circulating air oven or a thermo- may include substances permitted for stat controlled bath for a period of 8 such use by applicable regulations, as days. set forth in part 174 of this chapter. (4) The Pyrex glass pressure bottle is (c) Specifications. Maximum nitrogen then removed from the oven or bath content of the copolymer determined

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by micro-Kjeldahl analysis, shall not § 177.1200 Cellophane. exceed 8 percent. (d) Limitations. (1) The n-alkylglutar- Cellophane may be safely used for imide/acrylic copolymers in the fin- packaging food in accordance with the ished form in which they shall contact following prescribed conditions: food, when extracted with the solvent (a) Cellophane consists of a base or solvents characterizing the type of sheet made from regenerated cellulose food and under the conditions of time to which have been added certain op- and temperature described in tables 1 tional substances of a grade of purity and 2 of § 176.170(c) of this chapter, suitable for use in food packaging as shall yield extractives not to exceed constituents of the base sheet or as the limitations of § 177.1010(b) of this coatings applied to impart desired chapter, when prepared as strips, as de- technological properties. scribed in § 177.1010(c)(2) of this chapter. (b) Subject to any limitations pre- (2) The n-alkylglutarimide/acrylic co- scribed in this part, the optional sub- polymers shall not be used as polymer stances used in the base sheet and modifiers in vinyl chloride homo- or coating may include: copolymers. (1) Substances generally recognized (e) Conditions of use. The n- as safe in food. alkylglutarimide/acrylic copolymers (2) Substances for which prior ap- are used as articles or components of proval or sanctions permit their use in articles (other than articles composed cellophane, under conditions specified of vinyl chloride homo- or copolymers) in such sanctions and substances listed intended for use in contact with all in § 181.22 of this chapter. foods except beverages containing (3) Substances that by any regulation more than 8 percent alcohol under con- promulgated under section 409 of the ditions of use D, E, F, and G as de- act may be safely used as components scribed in table 2 of § 176.170(c) of this of cellophane. chapter. (4) Substances named in this section [54 FR 20382, May 11, 1989, as amended at 58 and further identified as required. FR 17098, Apr. 1, 1993] (c) List of substances:

Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)

Acrylonitrile-butadiene copolymer resins ...... As the basic polymer. Acrylonitrile-butadiene-styrene copolymer resins ...... Do. Acrylonitrile-styrene copolymer resins ...... Do. Acrylonitrile-vinyl chloride copolymer resins ...... Do. N-Acyl sarcosines where the acyl group is lauroyl or stearoyl ... For use only as release agents in coatings at levels not to exceed a total of 0.3 percent by weight of the finished packaging cellophane. Alkyl ketene dimers identified in § 176.120 of this chapter. Aluminum hydroxide. Aluminum silicate. Ammonium persulfate. Ammonium sulfate. Behenamide. Butadiene-styrene copolymer ...... As the basic polymer. 1,3-Butanediol. n-Butyl acetate ...... 0.1 percent. n-Butyl alcohol ...... Do. Calcium ethyl acetoacetate. Calcium stearoyl-2-lactylate identified in § 172.844 of this chap- Not to exceed 0.5 percent weight of cellophane. ter. Carboxymethyl hydroxyethylcellulose polymer. Castor oil, hydrogenated. Castor oil phthalate with adipic acid and fumaric acid-diethyl- As the basic polymer. ene glycol polyester. Castor oil phthalate, hydrogenated ...... Alone or in combination with other phthalates where total phthalates do not exceed 5 percent. Castor oil, sulfonated, sodium salt. Cellulose acetate butyrate. Cellulose acetate propionate. Cetyl alcohol. Clay, natural.

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Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)

Coconut oil fatty acid (C12-C18) diethanolamide, coconut oil For use only as an adjuvant employed during the processing of fatty acid (C12-C18) diethanolamine soap, and diethanolamine cellulose pulp used in the manufacture of cellophane base mixture having total alkali (calculated as potassium hydrox- sheet. ide) of 16–18% and having an acid number of 25–35. Copal resin, heat processed ...... As basic resin. Damar resin. Defoaming agents identified in § 176.200 of this chapter. Dialkyl ketones where the alkyl groups are lauryl or stearyl ...... Not to exceed a total of 0.35 percent. Dibutylphthalate ...... Alone or in combination with other phthalates where total phthalates do not exceed 5 percent. Dicyclohexyl phthalate ...... Do. Diethylene glycol ester of the adduct of terpene and maleic anhydride. Di(2-ethylhexyl) adipate. Di(2-ethylhexyl) phthalate...... Alone or in combination with other phthalates where total phthalates do not exceed 5 percent. Diisobutyl phthalate ...... Do. Dimethylcyclohexyl phthalate ...... Do.

Dimethyldialkyl (C8-C18) ammonium chloride ...... 0.005 percent for use only as a flocculant for slip agents. Di-n-ocyltin bis (2-ethylhexyl maleate) ...... For use only as a stabilizer at a level not to exceed 0.55 percent by weight of the coating solids in vinylidene chloride copolymer waterproof coatings prepared from vinylidene chloride copolymers identified in this paragraph, provided that such vinylidene chloride copolymers contain not less than 90 percent by weight of polymer units derived from vinylidene chloride. N,N′-Dioleoyethylenediamine, N,N′-dilinoleoylethylene-diamine 0.5 percent. and N-oleoyl-N′linoleoylethylene-diamine mixture produced when tall oil fatty acids are made to react with ethylenediamine such that the finished mixture has a melting point of 212°–228 °F., as determined by ASTM method D127–60 (‘‘Standard Method of Test for Melting Point of Petrolatum and Microcrystalline Wax’’ (Revised 1960), which is incorporated by reference; copies are available from University Microfilms International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Wash- ington, DC 20408), and an acid value of 10 maximum. N,N′-Dioleoylethylenediamine (N,N′-ethylenebisoleamide). Disodium EDTA. Distearic acid ester of di(hydroxyethyl) diethylenetriamine 0.06 percent. monoacetate. N,N′-Distearoylethylenediamine (N,N′-ethylenebis stearamide). Epoxidized polybutadiene ...... For use only as a primer subcoat to anchor surface coatings to the base sheet. Erucamide. Ethyl acetate. Ethylene-vinyl acetate copolymers complying with § 177.1350. 2-Ethylhexyl alcohol ...... 0.1 percent for use only as lubricant. Fatty acids derived from animal and vegetable fats and oils, and the following salts of such acids, single or mixed: Alu- minum, ammonium, calcium, magnesium, potassium, sodium. Ferrous ammonium sulfate. Fumaric acid. Glycerin-maleic anhydride ...... As the basic polymer. Glycerol diacetate. Glycerol monoacetate. Hydroxyethyl cellulose, water-insoluble. Hydroxypropyl cellulose identified in § 172.870 of this chapter. Isopropyl acetate ...... Residue limit 0.1 percent Isopropyl alcohol ...... Do. Itaconic acid. Lanolin. Lauryl alcohol. Lauryl sulfate salts: ammonium, magnesium, potassium, sodium. Maleic acid ...... 1 percent. Maleic acid adduct of butadienestyrene copolymer. Melamine formaldehyde ...... As the basic polymer.

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Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)

Melamine-formaldehyde modified with one or more of the fol- As the basic polymer, and used as a resin to anchor coatings lowing: Butyl alcohol, diaminopropane, diethylenetriamine, to substrate. ethyl alcohol, guanidine, imino-bis-butylamine, imino-bis-ethylamine, imino-bis-propylamine, methyl alcohol, polyamines made by reacting ethylenediamine or trimethylenediamine with dichloroethane or dichloropropane, sulfanilic acid, tetraethylenepentamine, triethanolamine, triethylenetetramine. Methyl ethyl ketone ...... Residue limit 0.1 percent Methyl hydrogen siloxane ...... 0.1 percent as the basic polymer. a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1a- methylstyrene to 3 vinyltoluene). Mineral oil, white. Mono- and bis-(octadecyldiethylene oxide) phosphates (CAS For use only as a release agent at a level not to exceed 0.6 Reg. No. 62362–49–6). percent by weight of coatings for cellophane. Naphthalenesulfonic acid-formaldehyde condensate, sodium 0.1 percent, for use only as an emulsifier. salt. Nitrocellulose, 10.9 percent–12.2 percent nitrogen. Nylon resins complying with § 177.1500. n-Octyl alcohol ...... For use only as a defoaming agent in the manufacture of cellophane base sheet. Olefin copolymers complying with § 177.1520. Oleic acid reacted with N-alkyl trimethylenediamine (alkyl C16 to C18). Oleic acid, sulfonated, sodium salt. Oleyl palmitamide. N,N′-Oleoyl-stearylethylenediamine (N-(2-stearoyl- aminoethyl)oleamide). Paraffin, synthetic, complying with § 175.250 of this chapter. Pentaerythritol tetrastearate ...... 0.1 percent. Polyamide resins derived from dimerized vegetable oil acids For use only in cellophane coatings that contact food at tem- (containing not more than 20 percent of monomer acids) and peratures not to exceed room temperature. ethylenediamine as the basic resin. Polyamide resins having a maximum acid value of 5 and a As the basic resin, for use only in coatings that contact food at maximum amine value of 8.5 derived from dimerized vege- temperatures not to exceed room temperature provided that table oil acids (containing not more than 10 percent mon- the concentration of the polyamido resins in the finished omer acids), ethylenediamine, and 4,4-bis(4- food-contact coating does not exceed 5 milligrams per hydroxyphenyl)pentanoic acid (in an amount not to exceed square inch of food-contact surface. 10 percent by weight of said polyamide resins). Polybutadiene resin (molecular weight range 2,000–10,200; For use only as an adjuvant in vinylidene chloride copolymer bromine number range 210–320). coatings. Polycarbonate resins complying with § 177.1580. Polyester resin formed by the reaction of the methyl ester of rosin, phthalic anhydride, maleic anhydride, and ethylene glycol, such that the polyester resin has an acid number of 4 to 11, a drop-softening point of 70 °C–92 °C, and a color of K or paler. Polyethylene. Polyethyleneaminostearamide ethyl sulfate produced when ste- 0.1 percent. aric acid is made to react with equal parts of diethylenetriamine and triethylenetetramine and the reaction product is quaternized with diethyl sulfate. Polyethylene glycol (400) monolaurate. Polyethylene glycol (600) monolaurate. Polyethylene glycol (400) monooleate. Polyethylene glycol (600) monooleate. Polyethylene glycol (400) monostearate. Polyethylene glycol (600) monostearate. Polyethylene, oxidized: complying with the identity prescribed in § 177.1620(a). Polyethylenimine ...... As the basic polymer, for use as a resin to anchor coatings to the substrate and for use as an impregnant in the food-contact surface of regenerated cellulose sheet in an amount not to exceed that required to improve heat-sealable bonding between coated and uncoated sides of cellophane. Polyisobutylene complying with § 177.1420. Polyoxypropylene-polyoxyethylene block polymers (molecular For use as an adjuvant employed during the processing of cel- weight 1,900–9,000). lulose pulp used in the manufacture of cellophane base sheet. Polypropylene complying with § 177.1520. Polystyrene ...... As the basic polymer. Polyvinyl acetate ...... Do.

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Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)

Polyvinyl alcohol (minimum viscosity of 4 percent aqueous solution at 20 °C of 4 centipoises). Polyvinyl chloride ...... As the basic polymer. Polyvinyl stearate ...... Do. n-Propyl acetate ...... Residue limit 0.1 percent. n-Propyl alcohol ...... Do. Rapeseed oil, blown. Rosins and rosin derivatives as provided in § 178.3870 of this chapter. Rubber, natural (natural latex solids). Silica. Silicic acid. Sodium m-bisulfite. Sodium dioctyl sulfosuccinate. Sodium dodecylbenzenesulfonate. Sodium lauroyl sarcosinate ...... 0.35 percent; for use only in vinylidene chloride copolymer coatings. Sodium oleyl sulfate-sodium cetyl sulfate mixture ...... For use only as an emulsifier for coatings; limit 0.005 percent where coating is applied to one side only and 0.01 percent where coating is applied to both sides. Sodium silicate. Sodium stearoyl-2-lactylate identified in § 172.846 of this chap- Not to exceed 0.5 percent weight of cellophane. ter. Sodium sulfate. Sodium sulfite. Spermaceti wax. Stannous oleate. 2-Stearamido-ethyl stearate. Stearyl alcohol. Styrene-maleic anhydride resins ...... As the basic polymer. Terpene resins identified in § 172.615 of this chapter. Tetrahydrofuran ...... Residue limit of 0.1 percent. Titanium dioxide. Toluene ...... Residue limit of 0.1 percent. Toluene sulfonamide formaldehyde ...... 0.6 percent as the basic polymer. Triethylene glycol. Triethylene glycol diacetate, prepared from triethylene glycol containing not more than 0.1 percent of diethylene glycol. 2,2,4-Trimethyl-1,3 pentanediol diisobutyrate ...... For use only in cellophane coatings and limited to use at a level not to exceed 10 percent by weight of the coating solids except when used as provided in § 178.3740 of this chapter Urea (carbamide). Urea formaldehyde ...... As the basic polymer. Urea formaldehyde modified with methanol, ethanol, butanol As the basic polymer, and used as a resin to anchor coatings diethylenetriamine, triethylenetetramine, tetraethylenepenta- to the substrate. mine, guanidine, sodium sulfite, sulfanilic acid, imino-bis-ethylamine, imino-bis-propylamine, imino-bis-butylamine, diaminopropane, diaminobutane, aminomethylsulfonic acid, polyamines made by reacting ethylenediamine or trimethylenediamine with dichlorethane or dichloropropane. Vinyl acetate-vinyl chloride copolymer resins ...... As the basic polymer. Vinyl acetate-vinyl chloride-maleic acid copolymer resins ...... Do. Vinylidene chloride copolymerized with one or more of the fol- Do. lowing: Acrylic acid, acrylonitrile, butyl acrylate, butyl methacrylate, ethyl acrylate, 2-ethylhexyl acrylate, 2-ethylhexyl methacrylate, ethyl methacrylate, itaconic acid, methacrylic acid, methyl acrylate, methyl methacrylate, propyl acrylate, propyl methacrylate, vinyl chloride. Vinylidene chloride-methacrylate decyloctyl copolymer ...... Do. Wax, petroleum, complying with § 178.3710 of this chapter.

(d) Any optional component listed in the provisions of § 180.22 of this chap- this section covered by a specific food ter. additive regulation must meet any [42 FR 14572, Mar. 15, 1977, as amended at 47 specifications in that regulation. FR 11842, Mar. 19, 1982; 64 FR 57978, Oct. 28, (e) Acrylonitrile copolymers identi- 1999] fied in this section shall comply with

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§ 177.1210 Closures with sealing gas- (1) Substances generally recognized kets for food containers. as safe in food. Closures with sealing gaskets may be (2) Substances used in accordance with the provisions of a prior sanction safely used on containers intended for or approval within the meaning of sec- use in producing, manufacturing, pack- tion 201(s) of the act. ing, processing, preparing, treating, (3) Substances that are the subject of packaging, transporting, or holding regulations in parts 174, 175, 176, 177, 178 food in accordance with the following and § 179.45 of this chapter and used in prescribed conditions: accordance with the conditions pre- (a) Closures for food containers are scribed. manufactured from substances gen- (4) Substances identified in para- erally recognized as safe for contact graph (b)(5) of this section, used in with food; substances that are subject amounts not to exceed those required to the provisions of prior sanctions; to accomplish the intended physical or substances authorized by regulations technical effect and in conformance in parts 174, 175, 176, 177, 178 and § 179.45 with any limitation provided; and fur- of this chapter; and closure-sealing ther provided that any substance em- gaskets, as further prescribed in this ployed in the production of closure- section. sealing gasket compositions that is the (b) Closure-sealing gaskets and over- subject of a regulation in parts 174, 175, all discs are formulated from sub- 176, 177, 178 and § 179.45 of this chapter stances identified in § 175.300(b) of this conforms with the identity or speci- chapter, with the exception of para- fications prescribed. graph (b)(3) (v), (xxxi), and (xxxii) of (5) Substances that may be employed that section, and from other optional in the manufacture of closure-sealing substances, including the following: gaskets include:

TABLE 1

Limitations (expressed as percent by weight of closure-sealing List of substances gasket composition)

Arachidy-l-behenyl amide (C20-C22fatty acid amides) ...... 5 percent. Azodicarbonamide ...... 1. 2 percent. 2. 5 percent; for use only in the manufacture of polyethylene complying with item 2.1 in § 177.1520(c) of this chapter. Balata rubber. Benzyl alcohol ...... 1 percent. Brominated isobutylene-isoprene copolymers, produced when isobutylene-isoprene copolymers complying with § 177.1420(a)(2) are modified by bromination with not more than 2.3 weight-percent of bromine and having a Mooney Viscosity (ML 1+8 (125 °C)) of 27 or higher. The viscosity is determined by the American Society for Testing and Mate- rials (ASTM) method D 1646–81, ‘‘Standard Test Method for Rubber—Viscosity and Vulcanization Characteristics (Moon- ey Viscometer),’’ which is incorporated by reference in accordance with 5 U.S.C. 522(a) and 1 CFR part 51. Copies are available from the Association of Official Analytical Chemists International, 481 North Frederick Ave., Suite 500, Gaithersburg, MD 20877-2504 and the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Ad- ministration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Wash- ington, DC. 1,3-Butanediol. Calcium tin stearate ...... 2 percent. Calcium zinc stearate ...... Do. Carbon, activated ...... 1 percent. Castor oil, hydrogenated ...... 2 percent. Chlorinated isobutylene-isoprene copolymers complying with § 177.1420. Coco amide (coconut oil fatty acids amides) ...... 2 percent. Cork (cleaned, granulated). Diebenzamide phenyl disulfide ...... 1 percent; for use only in vulcanized natural or synthetic rubber gasket compositions.

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TABLE 1—Continued

Limitations (expressed as percent by weight of closure-sealing List of substances gasket composition)

Di(C7, C9-alkyl) adipate ...... Complying with § 178.3740 of this chapter; except that, there is no limitation on polymer thickness. Di-2-ethylhexyl adipate. Di-2-ethylhexyl sebacate ...... 2 percent. Di-2-ethylhexyl terephthalate (CAS Reg. No. 006422–86–2). .... For use as a plasticizer at levels not exceeding 75 parts per hundred by weight of permitted vinyl chloride homo- and/or copolymer resins used in contact with food of Types I, II, IV– B, VI–A, VI–B, VI–C (up to 15 percent alcohol by volume), VII–B, and VIII described in § 176.170(c) of this chapter, table 1, and under conditions of use A through H described in § 176. 170 (c) of this chapter, table 2. Dihexyl ester of sodium sulfosuccinate ...... 1 percent. Diisodecyl phthalate ...... No limitation on amount used but for use only in closure-sealing gasket compositions used in contact with non-fatty foods containing no more than 8 percent of alcohol. Di-b-naphthyl-p-phenylenediamine ...... 1 percent. Dipentamethylenethiurametetrasulfide ...... 0.4 percent; for use only in vulcanized natural or synthetic rubber gasket compositions. Eicosane (technical grade) (water-white mixture of predominantly straight-chain paraffin hydrocarbons averaging 20 carbon atoms per molecule). Epoxidized linseed oil. Epoxidized linseed oil modified with trimellitic anhydride. Epoxidized safflower oil. Epoxidized safflower oil modified with trimellitic anhydride. Epoxidized soybean oil modified with trimellitic anhydride. Erucylamide ...... 5 percent. Ethylene-propylene copolymer. Ethylene-propylene modified copolymer elastomers produced when ethylene and propylene are copolymerized with 5- methylene-2-norbornene and/or 5-ethylidine-2-norbornene. The finished copolymer elastomers so produced shall contain not more than 5 weight-percent of total polymer units derived from 5-methylene-2-norbornene and/or 5-ethylidine- 2-norbornene, and shall have a minimum viscosity average molecular weight of 120,000 as determined by the method described in § 177.1520(d)(5), and a minimum Mooney viscosity of 35 as determined by the method described in § 177.1520(d)(6). Ethylene-vinyl acetate copolymer. Glyceryl mono-12-hydroxystearate (hydrogenated glyceryl 2 percent. ricinoleate). Gutta-percha. Hexamethylenetetramine ...... 1 percent. Hexylene glycol ...... 0.5 percent. Isobutylene-isoprene copolymers complying with § 177.1420. Maleic anhydride-polyethylene copolymer ...... 5 percent. Maleic anhydride-styrene copolymer ...... Do. 2,2′-Methylenebis[6-(1-methylcylcohexyl)-p-cresol] ...... 1 percent. Mixed octylated diphenylamine (CAS Reg. No. 68411–46–1) ... 0.1 percent in isobutylene-isoprene and chlorinated isobutylene-isoprene copolymers complying with § 177.1420, and brominated isobutylene-isoprene copolymers complying with this section. Napthalene sulfonic acid-formaldehyde condensate, sodium 0.2 percent. salt. Natural rubber (crepe, latex, mechanical dispersions). a-cis-9-Octadecenyl-omega-hydroxypoly (oxyethylene); the 0.5 percent. octadecenyl group is derived from oleyl alcohol and the poly (oxyethylene) content averages 20 moles. Oleyl alcohol ...... 1 percent. 4,4′-Oxybis (benzene sulfonyl hydrazide) ...... 0.5 percent. Paraformaldehyde ...... 1 percent. Polybutadiene. Poly-p-dinitroso benzene (activator for butyl rubber) ...... 1 percent; for use only in vulcanized natural or synthetic rubber gasket compositions. Polyethylene glycol 400 esters of fatty acids derived from ani- 1 percent. mal and vegetable fats and oils. Polyisobutylene complying with § 177.1420. Polyoxypropylene-polyoxyethylene condensate, average mol. 0.05 percent. wt. 2750–3000.

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TABLE 1—Continued

Limitations (expressed as percent by weight of closure-sealing List of substances gasket composition)

Polyurethane resins manufactured from diphenylmethane For use only: diisocyanate, 1,4-butanediol, and adipic acid (CAS Reg. No. No limitation on amount used, but for use only in closure 26375–23–5).. gasket compositions used in contact with food types VI–A and VI–C (up to 15 percent alcohol) under conditions of use D, E, F, and G, as described in § 176.170(c) of this chapter, tables 1 and 2, respectively. Potassium benzoate ...... 1 percent. Potassium perchlorate ...... Do. Potassium propionate ...... 2 percent. Potassium and sodium persulfate ...... 1 percent. Resorcinol ...... 0.24 percent; for use only as a reactive adjuvant substance employed in the production of gelatin-bonded cord compositions for use in lining crown closures. The gelatin so used shall be technical grade or better. Rosins and rosin derivatives as defined in § 175.300(b)(3)(v) of this chapter for use only in resinous and polymeric coatings on metal substrates; for all other uses as defined in § 178.3870 of this chapter. Sodium cetyl sulfate ...... 1 percent. Sodium decylbenzenesulfonate ...... Do. Sodium decyl sulfate ...... Do. Sodium formaldehyde sulfoxylate ...... 0.05 percent. Sodium lauryl sulfate ...... 1 percent. Sodium lignin sulfonate ...... 0.2 percent. Sodium myristyl sulfate (sodium tetradecyl sulfate) ...... 0.6 percent. Sodium nitrite ...... 0.2 percent; for use only in annular ring gaskets applied in aqueous dispersions to closures for containers having a capacity of not less than 5 gallons. Sodium o-phenylphenate ...... 0.05 percent. Sodium polyacrylate ...... 5 percent. Sodium and potassium pentachlorophenate ...... 0.05 percent. Sodium salt of trisopropyl napthalenesulfonic acid ...... 0.2 percent. Sodium tridecylsulfate ...... 0.6 percent. Stearic acid amide ...... 5 percent. Sulfur ...... For use only as a vulcanizing agent in vulcanized natural or synthetic rubber gasket compositions at a level not to exceed 4 percent by weight of the elastomer content of the rubber gasket composition. Tallow, sulfated ...... 1 percent. Tin-zinc stearate ...... 2 percent. Tri(mixed mono- and dinonylphenyl) phosphite ...... 1 percent. Vinyl chloride-vinyl stearate copolymer. Zinc dibutyldithiocarbamate ...... 0.8 percent; for use only in vulcanized natural or synthetic rubber gasket compositions.

TABLE 2—MAXIMUM EXTRACTIVES TOLERANCES TABLE 2—MAXIMUM EXTRACTIVES [In parts per million] TOLERANCES—Continued [In parts per million] Chloro- Chloro- Chloro- form form form Chloro- Type of closure-sealing gas- fraction fraction fraction Chloro- form Chloro- ket composition of water of of alco- form fraction form extrac- heptane hol ex- Type of closure-sealing gas- fraction of fraction tives extrac- tractives ket composition of water heptane of alco- tives extrac- extrac- hol ex- tives tives tractives 1. Plasticized polymers, including unvulcanized or 2. Preformed overall discs vulcanized or otherwise or annular rings of plasti- cured natural and syn- cized polymers, including thetic rubber formed in unvulcanized natural or place as overall discs or synthetic rubber ...... 50 250 50 annular rings from a hot 3. Preformed overall discs melt, solution, plastisol, or annular rings of vulcan- organisol, mechanical dis- ized plasticized polymers, persion, or latex ...... 50 500 50 including natural or synthetic rubber ...... 50 50 50

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TABLE 2—MAXIMUM EXTRACTIVES as determined from tables 3 and 4 shall TOLERANCES—Continued yield net chloroform-soluble extrac- [In parts per million] tives (corrected for zinc as zinc oleate) not to exceed the tolerances specified Chloro- Chloro- Chloro- in table 2, calculated on the basis of form form form Type of closure-sealing gas- fraction fraction fraction the water capacity of the container on ket composition of water of of alco- which the closure is to be used. Employ extrac- heptane hol ex- tives extrac- tractives the analytical method described in tives § 175.300 of this chapter, adapting the 4. Preformed overall discs procedural details to make the method or annular rings of poly- applicable to closures; such as, for ex- meric or resinous-coated ample, placing the closed glass con- paper, paperboard, plastic, or metal foil substrates 50 250 50 tainer on its side to assure contact of 5. Closures with sealing the closure’s food-contacting surface gaskets or sealing com- with the solvent. positions as described in 1, 2, 3, and 4, and including paper, paperboard, TABLE 3—TYPES OF FOOD and glassine used for dry I. Nonacid (pH above 5.0), aqueous products; may contain foods only ...... (1) (1) (1) salt or sugar or both, and including oil-in-water emulsions of low- or high-fat content. 1 Extractability tests not applicable. II. Acidic (pH 5.0 or below), aqueous products; may contain (c) The closure assembly to include salt or sugar or both, and including oil-in-water emulsions of low- or high-fat content. the sealing gasket or sealing com- III. Aqueous, acid or nonacid products containing free oil or pound, together with any polymeric or fat; may contain salt, and including water-in-oil emulsions resinous coating, film, foil, natural of low- or high-fat content. cork, or glass that forms a part of the IV. Dairy products and modifications: A. Water-in-oil emulsions, high- or low-fat. food-contact surface of the assembly, B. Oil-in-water emulsions, high- or low-fat. when extracted on a suitable glass con- V. Low-moisture fats and oils. tainer with a solvent or solvents char- VI. Beverages: acterizing the type of foods, and under A. Containing alcohol. B. Nonalcoholic. conditions of time and temperature VII. Bakery products. characterizing the conditions of its use VIII. Dry solids (no end-test required).

TABLE 4—TEST PROCEDURES WITH TIME-TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF EXTRACTIVES FROM CLOSURE-SEALING GASKETS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES

Types of food (see Extractant Conditions of use table 3) Water 2 Heptane 12 8 percent alcohol 2

A. High temperature heat-sterilized I, IV–B ...... 250 °F, 2 hr ...... (e.g., over 212 °F). III, IV–A, VII ...... do ...... 150 °F, 2 hr. B. Boiling water-sterilized ...... II ...... 212 °F, 30 min ...... III, VII ...... do ...... 120 °F, 30 min. C. Hot filled or pasteurized above 150 II, IV–B ...... Fill boiling, cool to . °F. III, IV–A ...... 100 °F. 120 °F, 15 min. V ...... do ...... do. D. Hot filled or pasteurized below 150 II, IV–B, VI–B ...... 150 °F, 2 hr ...... °F. III, IV–A ...... do ...... 100 °F, 30 min. 150 °F, 2 hr V ...... do ...... VI–A ...... E. Temperature filled and stored (no II, IV–B, VI–B ...... 120 °F, 24 hr ...... thermal treatment in the container). III, IV–A ...... do ...... 70 °F, 30 min. 120 °F, 24 hr. V ...... do ...... VI–A ...... F. Refrigerated storage (no thermal I, II, III, IV–A, IV–B, 70 °F, 48 hr ...... 70 °F, 30 min ...... treatment). VI–B, VII. 70 °F, 48 hr. VI–A ...... G. Frozen storage (no thermal treat- I, II, III, IV–B, VII ... 70 °F, 24 hr ...... ment in the container).

1 Heptane extractant not applicable to closure-sealing gaskets overcoated with wax. 2 Time and temperature.

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[42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 47 FR 22090, May 21, 1982; 49 FR 5748, Feb. 15, 1984; 55 FR 34555, Aug. 23, 1990; 61 FR 14480, Apr. 2, 1996; 65 FR 26745, May 9, 2000; 65 FR 52908, Aug. 31, 2000]

§ 177.1211 Cross-linked polyacrylate ‘‘tea bag’’ or infuser), under an applied copolymers. pressure of 0.15 pounds per square inch Cross-linked polyacrylate copoly- (for example, a 4x6 inch square pad is mers identified in paragraph (a) of this subjected to a 1.6 kilograms applied section may be safely used as articles mass). The solvent used shall be at or components of articles intended for least 60 milliliters aqueous sodium use in contact with food in accordance chloride solution per gram of copoly- with the following prescribed condi- mer. (d) Conditions of use. The copolymers tions: identified in paragraph (a)(1) of this (a) Identity. For the purpose of this section are limited to use as a fluid ab- section, the cross-linked polyacrylate sorbent in food-contact materials used copolymers consist of: in the packaging of frozen or refrig- (1) The grafted copolymer of cross- erated poultry. The copolymers identi- linked sodium polyacrylate identified fied in paragraph (a)(2) of this section as 2-propenoic acid, polymers with N,N- are limited to use as a fluid absorbent di-2-propenyl-2-propen-1-amine and in food-contact materials used in the hydrolyzed polyvinyl acetate, sodium packaging of frozen or refrigerated salts, graft (CAS Reg. No. 166164–74–5); meat and poultry. or (2) 2-propenoic acid, polymer with 2- [64 FR 28098, May 25, 1999, as amended at 65 ethyl-2-(((1-oxo-2-pro- FR 16817, Mar. 30, 2000] penyl)oxy)methyl)-1,3-propanediyl di-2- § 177.1240 1,4-Cyclohexylene propenoate and sodium 2-propenoate dimethylene terephthalate and 1,4- (CAS Reg. No. 76774–25–9). cyclohexylene dimethylene (b) Adjuvants. The copolymers identi- isophthalate copolymer. fied in paragraph (a) of this section Copolymer of 1,4-cyclohexylene may contain optional adjuvant sub- dimethylene terephthalate and 1,4- stances required in the production of cyclohexylene dimethylene isophtha- such copolymers. The optional adju- late may be safely used as an article or vant substances may include sub- component of articles used in pro- stances permitted for such use by regu- ducing, manufacturing, packing, proc- lations in parts 170 through 179 of this essing, preparing, treating, packaging, chapter, substances generally recog- transporting, or holding food, subject nized as safe in food, and substances to the provisions of this section: used in accordance with a prior sanc- (a) The copolymer is a basic poly- tion or approval. ester produced by the catalytic con- (c) Extractives limitations. The copoly- densation of dimethyl terephthalate mers identified in paragraph (a) of this and dimethyl isophthalate with 1,4- section, in the finished form in which cyclohexanedimethanol, to which may they will contact food, must yield low have been added certain optional sub- molecular weight (less than 1,000 Dal- stances required in its production or tons) extractives of no more than 0.15 added to impart desired physical and percent by weight of the total polymer technical properties. when extracted with 0.2 percent by (b) The quantity of any optional sub- weight of aqueous sodium chloride so- stance employed in the production of lution at 20 °C for 24 hours. The low the copolymer does not exceed the molecular weight extractives shall be amount reasonably required to accom- determined using size exclusion chro- plish the intended physical or technical matography or an equivalent method. effect or any limitation further pro- When conducting the extraction test, vided. the copolymer, with no other absorp- (c) Any substance employed in the tive media, shall be confined either in production of the copolymer that is the a finished absorbent pad or in any suit- subject of a regulation in parts 174, 175, able flexible porous article, (such as a 176, 177, 178 and § 179.45 of this chapter

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conforms with any specification in ic acid, when extracted with the sol- such regulation. vent or solvents characterizing the (d) Substances employed in the pro- type of food and under the conditions duction of the copolymer include: of its intended use as determined from (1) Substances generally recognized tables 1 and 2 of § 176.170(c) of this chap- as safe in food. ter, yield net acidified chloroform-solu- (2) Substances subject to prior sanc- ble extractives not to exceed 0.5 milli- tion or approval for use in the copoly- gram per square inch of food-contact mer and used in accordance with such surface when tested by the methods sanction or approval. prescribed in § 177.1330(e)(1), (3)(i) (3) Substances which by regulation in through (iv), (4), (5), and (6), except parts 174, 175, 176, 177, 178 and § 179.45 of that this chapter may be safely used as (1) The total residue method using 3 components of resinous or polymeric percent acetic acid, as prescribed in coatings and film used as food-contact § 177.1330(e)(6)(i)(a), does not apply, and surfaces, subject to the provisions of (2) The net acidified chloroform-solu- such regulation. ble extractives from paper and paper- (e) The copolymer conforms with the board complying with § 176.170 of this following specifications: chapter may be corrected for wax, pet- (1) The copolymer, when extracted rolatum, and mineral oil as provided in with distilled water at reflux tempera- § 176.170(d)(5)(iii)(b) of this chapter. ture for 2 hours, yields total extractives not to exceed 0.05 percent. If the finished food-contact article is (2) The copolymer, when extracted itself the subject of a regulation in with ethyl acetate at reflux tempera- parts 174, 175, 176, 177, 178, and § 179.45 of ture for 2 hours, yields total extrac- this chapter, it shall also comply with tives not to exceed 0.7 percent. any specifications and limitations pre- (3) The copolymer, when extracted scribed for it by that regulation. with n-hexane at reflux temperature (c) The finished food-contact layer for 2 hours, yields total extractives not made with basic copolymers containing to exceed 0.05 percent. more than 10 weight-percent but no more than 25 weight-percent of total [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, polymer units derived from acrylic 1984, as amended at 55 FR 34555, Aug. 23, 1990] acid and with a maximum thickness of § 177.1310 Ethylene-acrylic acid co- 0.0025 inch (2.5 mils) may be used in polymers. contact with food types I, II, IVB, VIA, VIB, VIIB, and VIII identified in table The ethylene-acrylic acid copolymers 1 of § 176.170(c) of the chapter under identified in paragraph (a) of this sec- conditions of use B through H as de- tion may be safely used as components scribed in table 2 of § 176.170(c) of this of articles intended for use in contact chapter, and in contact with food types with food subject to the provisions of III, IVA, V, VIIA, and IX identified in this section. table 1 of § 176.170(c) of this chapter (a) The ethylene-acrylic acid copoly- under conditions of use E through G as mers consist of basic copolymers pro- described in table 2 of § 176.170(c) of this duced by the copolymerization of chapter. ethylene and acrylic acid such that the (d) The provisions of this section are finished basic copolymers contain no not applicable to ethylene-acrylic acid more than: copolymers used in food-packaging ad- (1) 10 weight-percent of total polymer hesives complying with § 175.105 of this units derived from acrylic acid when chapter. used in accordance with paragraph (b) of this section; and [42 FR 14572, Mar. 15, 1977, as amended at 51 (2) 25 weight-percent of total polymer FR 19060, May 27, 1986; 53 FR 44009, Nov. 1, units derived from acrylic acid when 1988] used in accordance with paragraph (c) of this section. § 177.1312 Ethylene-carbon monoxide (b) The finished food-contact articles copolymers. made with no more than 10 percent The ethylene-carbon monoxide co- total polymer units derived from acryl- polymers identified in paragraph (a) of

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this section may be safely used as com- tracted with the solvent or solvents ponents of articles intended for use in characterizing the type of food and contact with food subject to the provi- under the conditions of time and tem- sions of this section. perature characterizing the conditions (a) Identity. For the purposes of this of its intended use, as determined from section, ethylene-carbon monoxide co- tables 1 and 2 of § 176.170(c) of this chap- polymers (CAS Reg. No. 25052–62–4) con- ter, yields net chloroform-soluble ex- sist of the basic polymers produced by tractives in each extracting solvent the copolymerization of ethylene and not to exceed 0.5 milligram per square carbon monoxide such that the copoly- inch of food-contact surface when test- mers contain not more than 30 weight- ed by methods described in § 176.170(d) percent of polymer units derived from of this chapter. carbon monoxide. (4) The provisions of this section are (b) Conditions of use. (1) The polymers not applicable to ethylene-carbon mon- may be safely used as components of oxide copolymers complying with the food-contact or interior core layer § 175.105 of this chapter. of multilaminate food-contact articles. (2) The polymers may be safely used [57 FR 32422, July 22, 1992] as food-contact materials at temperatures not to exceed 121 °C (250 °F). § 177.1315 Ethylene-1, 4-cyclohexylene (c) Specifications. (1) Food-contact dimethylene terephthalate copolymers. layers formed from the basic copolymer identified in paragraph (a) of this Ethylene-1, 4-cyclohexylene section shall be limited to a thickness dimethylene terephthalate copolymer of not more than 0.01 centimeter (0.004 may be safely used as articles or com- inch). ponents of articles intended for use in (2) The copolymers identified in para- contact with food subject to provisions graph (a) of this section shall have a of this section and of part 174 of this melt index not greater than 500 as de- chapter. termined by ASTM method D1238–82, (a) Identity. For the purposes of this condition E ‘‘Standard Test Method for section, ethylene-1,4-cyclohexylene Flow Rates of Thermoplastics by Ex- dimethylene terephthalate copolymers trusion Plastometer,’’ which is incor- (1,4-benzene dicarboxylic acid, di- porated by reference in accordance methyl ester, polymerized with 1,4- with 5 U.S.C. 552(a) and 1 CFR part 51. cyclohexanedimethanol and 1,2- Copies may be obtained from the Amer- ethanediol) (CAS Reg. No. 25640–14–6) or ican Society for Testing Materials, 1916 (1,4-benzenedicarboxylic acid, polym- Race St., Philadelphia, PA 19103, or erized with 1,4-cyclohexanedimethanol may be examined at the Center for and 1,2-ethanediol) (CAS Reg. No. Food Safety and Applied Nutrition 25038–91–9) are basic copolymers meet- (HFS–200), Food and Drug Administra- ing the specifications prescribed in tion, 5100 Paint Branch Pkwy., College paragraph (b) of this section, to which Park, MD 20740, or at the Office of the may have been added certain optional Federal Register, 800 North Capitol St. substances required in their production NW., suite 700, Washington, DC. or added to impart desired physical or (3) The basic copolymer identified in technical properties. paragraph (a) of this section, when ex- (b) Specifications:

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Maximum extractable fractions of the copolymer in the fin- Ethylene-1,4- ished form at specified tem- cyclohexylene peratures and times (ex- Test for dimethylene Inherent viscosity pressed in micrograms of the orientability Conditions of use terephthalate copolymers terephthaloyl moletles/square centimeter of food-contact surface)

1. Non-oriented ethyl- Inherent viscosity (1) 0.23 microgram per square No test required ... In contact with foods, in- ene-1,4-cyclohexylene of a 0.50 per- centimeter (1.5 micrograms cluding foods con- dimethylene cent solution of per square inch) of food-containing not more than terephthalate copoly- the copolymer in tact surface when extracted 25 percent (by vol- mer is the reaction phenol-tet with water added at 82.2 °C ume) aqueous alcohol, product of dimethyl rachloroethane (180 °F) and allowed to cool excluding carbonated terephthalate or ter- (60:40 ratio wt/ to 48.9 °C (120 °F) in con- beverages and beer. ephthalic acid with a wt) solvent is tact with the food-contact ar- Conditions of hot fill mixture containing 99 not less than ticle. not to exceed 82.2 °C to 66 mole percent of 0.669 as deter- (180 °F), storage at ethylene glycol and 1 mined by using temperatures not in to 34 mole percent of a Wagner vis- excess of 48.9 °C 1,4-cyclo- cometer (or (120 °F). No thermal hexanedimethanol (70 equivalent) and treatment in the con- percent trans isomer, calculated from tainer. 30 percent cls isomer). the following equation: Inher- ent viscosity = (Natural loga- rithm of (Nr)/(c) where: Nr=Ratio of flow time of the polymer solution to that of the solvent, and c=concentration of the test solution expressed in grams per 100 milliliters...... do ...... (2) 0.23 microgram per square ...... do ...... Do. centimeter (1.5 micrograms per square inch) of food-contact surface when extracted with 3 percent (by volume) aqueous acetic acid added at 82.2 °C (180 °F) and allowed to cool to 48.9 °C (120 °F) in contact with the food-contact article...... do ...... (3) 0.08 microgram per square ...... do ...... Do. centimeter (0.5 microgram per square inch) of food-contact surface when extracted for 2 hours with n-heptane at 48.9 °C (120 °F). The heptane extractable results are to be divided by a factor of 5...... do ...... (4) 0.16 microgram per square ...... do ...... Do. centimeter (1.0 microgram per square inch) of food-contact surface when extracted for 24 hours with 25 percent (by volume) aqueous ethanol at 48.9 °C (120 °F).

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2. Oriented ethylene-1,4- ...... do ...... (1) 0.23 microgram per square When extracted In contact with non- cyclohexylene centimeter (1.5 micrograms with heptane at alcoholic foods includ- dimethylene per square inch) of food-con- 65.6 °C (150 °F) ing carbonated bev- terephthalate copoly- tact surface of the oriented for 2 hours: erages. Conditions of mer is the reaction copolymer when extracted terephthaloyl hot fill not exceeding product of dimethyl with water added at 87.8 °C moieties do not 87.8 °C (190 °F), stor- terephthalate or ter- (190 °F) and allowed to cool exceed 0.09 age at temperatures ephthalic acid with a to 48.9 °C (120 °F) in con- microgram per not in excess of 48.9 mixture containing 99 tact with the food-contact ar- square centi- °C (120 °F). No ther- to 85 mole percent ticle. meter (0.60 mal treatment in the ethylene glycol and 1 microgram per container. to 15 mole percent of square inch) of 1,4-cyclohexane-di- food-contact methanol (70 percent surface. trans isomer, 30 percent cls isomer)...... do ...... (2) 0.23 microgram per square ...... do ...... Do. centimeter (1.5 micrograms per square inch) of food-contact surface of oriented copolymer when extracted with 3 percent (by volume) aqueous acetic acid added at 87.8 °C (190 °F) and allowed to cool to 48.9 °C (120 °F) in contact with the food-contact article...... do ...... (3) 0.08 microgram per square ...... do ...... Do. centimeter (0.5 microgram per square inch) of food-contact surface of oriented copolymer when extracted for 2 hours with n-heptane at 48.9 °C (120 °F). The heptane extractable results are to be divided by a factor of 5...... do ...... (4) 0.23 microgram per square ...... do ...... In contact with foods and centimeter (1.5 micrograms beverages containing per square inch) of food-con- up to 20 percent (by tact surface of oriented co- volume) alcohol. Con- polymer when extracted with ditions of thermal 20 percent (by volume) treatment in the con- aqueous ethanol heated to tainer not exceeding 65.6 °C (150 °F) for 20 min- 65.6 °C (150 °F) for utes and allowed to cool to 20 minutes. Storage at 48.9 °C (120 °F) in contact temperatures not in with the food-contact article. excess of 48.9 °C (120 °F)...... do ...... (5) 0.23 microgram per square ...... do ...... In contact with foods and centimeter (1.5 micrograms beverages containing per square inch) of food-con- up to 50 percent (by tact surface of oriented co- volume) alcohol. Con- polymer when extracted with ditions of fill and stor- 50 percent (by volume) age not exceeding aqueous ethanol at 48.9 °C 48.9 °C (120 °F). No (120 °F) for 24 hours. thermal treatment in the container.

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3. Ethylene-1,4- No test required ... For each corresponding condi- No test required ... For each corresponding cyclohexylene tion of use, must meet speci- specification, may be dimethylene fications described in used as a base sheet terephthalate copoly- § 177.1630(f), (g), (h), or (j). and base polymer in mer is the reaction accordance with con- product of dimethyl ditions of use de- terephthalate or ter- scribed in ephthalic acid with a § 177.1630(f), (g), (h), mixture containing 99 or (j). to 95 mole percent of ethylene glycol and 1 to 5 mole percent of 1,4- cyclohexanedimethanol (70 percent trans isomer, 30 percent cis isomer).

(c) Analytical method for determination with the following prescribed condi- of extractability. The total extracted tions: terephthaloyl moieties can be deter- (a) Ethylene-ethyl acrylate copoly- mined in the extracts, without evapo- mers consist of basic resins produced ration of the solvent, by measuring the by the catalytic copolymerization of ultraviolet (UV) absorbance at 240 ethylene and ethyl acrylate, to which nanometers. The spectrophotometer may have been added certain optional (Varian 635–D, or equivalent) is zeroed substances to impart desired techno- with a sample of the solvent taken logical properties to the resin. Subject from the same lot used in the extrac- to any limitations prescribed in this tion tests. The concentration of the section, the optional substances may total terephthaloyl moieties in water, 3 include: percent acetic acid, and in 8 percent (1) Substances generally recognized aqueous alcohol is calculated as bis(2- as safe in food and food packaging. hydroxyethyl terephthalate) by ref- (2) Substances the use of which is erence to standards prepared in the ap- permitted under applicable regulations propriate solvent. Concentration of the in parts 170 through 189 of this chapter, terephthaloyl moieties in heptane is prior sanction, or approvals. calculated as cyclic trimer (b) The ethyl acrylate content of the copolymer does not exceed 8 percent by (C6H4CO2C2H4CO2)3, by reference to standards prepared in 95:5 percent (v/v) weight unless it is blended with polyethylene or with one or more olefin co- heptane: tetrahydrofuran. polymers complying with § 177.1520 or [45 FR 39252, June 10, 1980, as amended at 47 with a mixture of polyethylene and one FR 24288, June 4, 1982; 49 FR 25629, June 22, or more olefin copolymers, in such pro- 1984; 51 FR 22929, June 24, 1986; 60 FR 57926, portions that the ethyl acrylate con- Nov. 24, 1995] tent of the blend does not exceed 8 percent by weight, or unless it is used in § 177.1320 Ethylene-ethyl acrylate co- a coating complying with § 175.300 or polymers. § 176.170 of this chapter, in such propor- Ethylene-ethyl acrylate copolymers tions that the ethyl acrylate content may be safely used to produce pack- does not exceed 8 percent by weight of aging materials, containers, and equip- the finished coating. ment intended for use in producing, (c) Ethylene-ethyl acrylate copoly- manufacturing, packing, processing, mers or the blend shall conform to the preparing, treating, packaging, trans- specifications prescribed in paragraph porting, or holding food, in accordance (c)(1) of this section and shall meet the

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ethyl acrylate content limits pre- § 177.1330 Ionomeric resins. scribed in paragraph (b) of this section, Ionomeric resins manufactured from and the extractability limits pre- either ethylene-methacrylic acid co- scribed in paragraph (c)(2) of this sec- polymers (and/or their ammonium, cal- tion, when tested by the methods pre- cium, magnesium, potassium, sodium, scribed for polyethylene in § 177.1520. and/or zinc partial salts), ethylene- (1) Specifications—(i) Infrared identi- methacrylic acid-vinyl acetate copoly- fication. Ethylene-ethyl acrylate co- mers (and/or their ammonium, cal- polymers can be identified by their cium, magnesium, potassium, sodium, characteristic infrared spectra. and/or zinc partial salts,), or meth- (ii) Quantitative determination of ethyl acrylic acid polymers with ethylene acrylate content. The ethyl acrylate can and isobutyl acrylate (and/or their po- be determined by the infrared spectra. tassium, sodium and/or zinc partial Prepare a scan from 10.5 microns to 12.5 salts) may be safely used as articles or microns. Obtain a baseline absorbance components of articles intended for use in contact with food, in accordance at 11.6 microns and divide by the with the following prescribed condi- plaque thickness to obtain absorbance tions: per mil. From a previously prepared (a) For the purpose of this section, calibration curve, obtain the amount of the ethylene-methacrylic acid copoly- ethyl acrylate present. mers consist of basic copolymers pro- (iii) Specific gravity. Ethylene-ethyl duced by the copolymerization of acrylate copolymers have a specific ethylene and methacrylic acid such gravity of not less than 0.920 nor more that the copolymers contain no more than 0.935, as determined by ASTM than 20 weight percent of polymer method D1505–68 (Reapproved 1979), units derived from methacrylic acid, ‘‘Standard Test Method for Density of and the ethylene-methacrylic acid- Plastics by the Density-Gradient Tech- vinyl acetate copolymers consist of nique,’’ which is incorporated by ref- basic copolymers produced by the co- erence. Copies may be obtained from polymerization of ethylene, meth- the American Society for Testing Ma- acrylic acid, and vinyl acetate such terials, 1916 Race St., Philadelphia, PA that the copolymers contain no more than 15 weight percent of polymer 19103, or may be examined at the Office units derived from methacrylic acid. of the Federal Register, 800 North Cap- (b) For the purpose of this section, itol Street, NW., suite 700, Washington, the methacrylic acid copolymers with DC 20408. ethylene and isobutyl acrylate consist (2) Limitations. Ethylene-ethyl acry- of basic copolymers produced by the late copolymers or the blend may be copolymerization of methacrylic acid, used in contact with food except as a ethylene, and isobutyl acrylate such component of articles used for pack- that the copolymers contain no less aging or holding food during cooking than 70 weight percent of polymer provided they meet the following units derived from ethylene, no more extractability limits: than 15 weight percent of polymer (i) Maximum soluble fraction of 11.3 units derived from methacrylic acid, percent in xylene after refluxing and and no more than 20 weight percent of subsequent cooling to 25 °C. polymer units derived from isobutyl (ii) Maximum extractable fraction of acrylate. From 20 percent to 70 percent 5.5 percent when extracted with n- of the carboxylic acid groups may op- hexane at 50 °C. tionally be neutralized to form sodium (d) The provisions of paragraphs (b) or zinc salts. and (c)(2) of this section are not appli- (c) The finished food-contact article described in paragraph (a) of this sec- cable to ethylene-ethyl acrylate co- tion, when extracted with the solvent polymers used in the formulation of ad- or solvents characterizing the type of hesives complying with § 175.105 of this food and under the conditions of time chapter. and temperature characterizing the [42 FR 14572, Mar. 15, 1977, as amended at 49 conditions of its intended use as deter- FR 10108, Mar. 19, 1984] mined from tables 1 and 2 of § 176.170(c)

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of this chapter, yields net acidified square inch 2(0.003 milligram/square chloroform-soluble extractives in each centimeter) of food-contact surface extracting solvent not to exceed 0.5 (water, acetic acid, or ethanol/water milligram per square inch of food-con- extractions) when extracted by the ab- tact surface when tested by the meth- breviated method cited in paragraph ods described in paragraph (e)(1) of this (e)(2)(i) of this section. section, and if the finished food-con- (ii) Alternatively, the net acidified tact article is itself the subject of a chloroform-soluble extractives shall regulation in parts 174, 175, 176, 177, 178 not exceed 0.05 milligram/square inch 3 and § 179.45 of this chapter, it shall also (0.078 mg/square centimeter) of food- comply with any specifications and contact surface (water, acetic acid, or limitations prescribed for it by that ethanol/water extractions) when ex- regulation. tracted by the equilibrium method NOTE: In testing the finished food-contact cited in paragraph (e)(2)(ii) of this sec- article, use a separate test sample for each tion. If when exposed to n-heptane, a required extracting solvent. particular film splits along die lines, (d) The finished food-contact article thus permitting exposure of both sides described in paragraph (b) of this sec- of the film to the extracting solvent, tion, when extracted according to the the results for that film sample are in- methods listed in paragraph (e)(2) of valid and the test must be repeated for this section and referenced in this that sample until no splitting by the paragraph (d), using the solvent or sol- solvent occurs. If the finished food-con- vents characterizing the type of food as tact article is itself the subject of a determined from table I of paragraph regulation in parts 174, 175, 176, 177, 178 (f) of this section, shall yield net acidi- and § 179.45 of this chapter, it shall also fied chloroform-soluble extractives as comply with any specifications and follows: limitations prescribed for it by that (1) For fatty food use. (i) For films of regulation. 2 mil (0.002 inches) thickness or less, NOTE: In testing the finished food-contact extractives shall not exceed 0.70 milli- article, use a separate test sample for each gram/square inch 1 (0.109 milligram/ required extracting solvent. (e) (1) square centimeter) of food-contact sur- Analytical methods— Selection of extractability conditions for ionomeric res- face (n-heptane extractions) when ex- ins. First ascertain the type of food tracted by the abbreviated method (table 1 of § 176.170(c) of this chapter) cited in paragraph (e)(2)(i) of this sec- that is being packed or used in contact tion. with the finished food-contact article (ii) For films of greater than 2 mils described in paragraph (a) of this sec- (0.002 inch) thickness, extractives shall 1 tion, and also ascertain the normal not exceed 0.40 milligram/square inch conditions of thermal treatment used (0.062 milligram/square centimeter) of in packaging or contacting the type of food-contact surface (n-heptane extrac- food involved. Using table 2 of § 176.170 tions) when extracted by the abbre- (c) of this chapter, select the food-sim- viated method cited in paragraph ulating solvent or solvents and the (e)(2)(i) of this section, or time-temperature test conditions that (iii) Alternatively, for films of great- correspond to the intended use of the er than 2 mils thickness, extractives finished food-contact article. Having shall not exceed 0.70 milligram/square selected the appropriate food-simu- 1 inch (0.109 milligram/square centi- lating solvent or solvents and time- meter) of food-contact surface (n- temperature exaggeration over normal heptane extractions) when extracted by use, follow the applicable extraction the equilibrium method cited in para- procedure. graph (e)(2)(ii) of this section. (2) Selection of extractability conditions (2) For aqueous foods. (i) The net for ionomeric resins. Using table I of acidified chloroform-soluble extractives shall not exceed 0.02 milligram/ 2 Average of four separate values, no single value of which differs from the average of 1 Average of four separate values, no single those values by more than ±50 percent. value of which differs from the average of 3See footnote 2 to paragraph (d)(2)(i) of this those values by more then ±10 percent. section.

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paragraph (f) of this section ascertain (ii) n-Heptane. Reagent grade, freshly the type of food that is being packed or redistilled before use, using only mate- used in contact with the finished food- rial boiling at 208 °F (97.8 °C). contact article described in paragraph (iii) Alcohol. 8 or 50 percent (by vol- (b) of this section, and also ascertain ume), prepared from undenatured 95 the food-simulating solvent or solvents percent ethyl alcohol diluted with that correspond to the intended use of demineralized (deionized), distilled the finished food-contact article. water. (i) Abbreviated test. For intended use (iv) Chloroform. Reagent grade, fresh- involving food contact at or below 120 ly redistilled before use, or a grade °F (49 °C), the appropriate food-simu- having an established, consistently low lating solvent is to contact the food- blank. contact film for the time and tempera- (v) Acetic acid. 3 percent (by weight), tures as follows: prepared from glacial acetic acid diluted with demineralized (deionized), Solvent Time Temperature distilled water. n-Heptane ...... 1 2 120 °F (49 °C). (4) Selection of test method. The fin- Water, 3% acetic acid, or 8%/ 1 48 120 °F (49 °C). ished food-contact articles shall be 50% ethanol. tested either by the extraction cell de- 1 Hours scribed in the Journal of the Association (ii) Equilibrium test. For intended use of Official Agricultural Chemists, Vol. 47, involving food contact at or below 120 No. 1, p. 177–179 (February 1964), also °F (49 °C), the appropriate food-simu- described in ASTM method F34–76 (Re- lating solvent is to contact the food- approved 1980), ‘‘Standard Test Method contact film at a temperature of 120 °F for Liquid Extraction of Flexible Bar- until equilibrium is demonstrated. rier Materials,’’ which are incorporated by reference, or by adapting the in-con- Minimum tainer methods described in § 175.300(e) extraction Solvent times of this chapter. Copies of the material (hours) incorporated by reference are available n-Heptane ...... 8, 10, 12 from the Center for Food Safety and Water, 3% acetic acid, or 8%/50% ethanol ...... 72, 96, Applied Nutrition (HFS–200), Food and 120 Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, The results from a series of extraction and the American Society for Testing times demonstrate equilibrium when Materials, 1916 Race St., Philadelphia, the net chloroform-soluble extractives PA 19103, respectively, or may be exam- are unchanging within experimental ined at the Office of the Federal Reg- error appropriate to the method as de- ister, 800 North Capitol Street, NW., scribed in paragraphs (d) (1)(i) and (2)(i) suite 700, Washington, DC 20408. of this section. Should equilibrium not (5) Selection of samples. Quadruplicate be demonstrated over the above time samples should be tested, using for series, extraction times must be ex- each replicate sample the number of tended until three successive unchang- finished articles with a food-contact ing values for extractives are obtained. surface nearest to 100 square inches. In the case where intended uses involve (6) Determination of amount of extrac- temporary food contact above 120 °F, tives—(i) Total residues. At the end of the food-simulating solvent is to be the exposure period, remove the test contacted with the food-contact article container or test cell from the oven, if under conditions of time and tempera- any, and combine the solvent for each ture that duplicate the actual condi- replicate in a clean Pyrex (or equiva- tions in the intended use. Subsequently lent) flask or beaker, being sure to the extraction is to be continued for rinse the test container or cell with a the time period and under the condi- small quantity of clean solvent. Evapo- tions specified in the above table. rate the food-simulating solvents to (3) Reagents—(i) Water. All water used about 100 milliliters in the flask, and in extraction procedures should be transfer to a clean, tared evaporating freshly demineralized (deionized) dis- dish (platinum or Pyrex), washing the tilled water. flask three times with small portions

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of solvent used in the extraction proce- dish, the filter paper, and the sepa- dure, and evaporate to a few milliliters ratory funnel with this second portion on a nonsparking, low-temperature of chloroform. Add this filtrate to the hotplate. The last few milliliters original filtrate and evaporate the should be evaporated in an oven main- total down to a few milliliters on a tained at a temperature of 221 °F (105 low-temperature hotplate. The last few °C). Cool the evaporating dish in a des- milliliters should be evaporated in an iccator for 30 minutes and weigh the oven maintained at 221 °F. Cool the residues to the nearest 0.1 milligram, e. evaporating dish in a desiccator for 30 Calculate the extractives in milligrams minutes and weigh to the nearest 0.1 per square inch of the container or ma- milligram to get the acidified chloro- terial surface. form-soluble extractives residue, e′. (a) Water, 3 percent acetic acid, and 8 This e′ is substituted for e in the equa- percent and 50 percent alcohol. Milli- tions in paragraphs (e)(6)(i) (a) and (b) grams extractives per square inch=e/s. (b) Heptane. Milligrams extractives of this section. per square inch=(e)/(s)(F) (f) The types of food and appropriate solvents are as follows: where: e=Milligrams extractives per sample tested. TABLE 1 s=Surface area tested, in square inches. F=Five, the ratio of the amount of extrac- Types of food Appropriate solvent tives removed by heptane under exaggerated time-temperature test conditions 1. Nonacid (pH above 5.0), aque- Water, n-heptane. compared to the amount extracted by a fat ous products; may contain salt or sugar or both, and including or oil under exaggerated conditions of oil-in-water emulsions of low- or thermal sterilization and use. high-fat content. e′=Acidified chloroform-soluble extractives 2. Acidic (pH 5.0 or below), aque- n-heptane, water, 3% residue. e′ is substituted for e in the above ous products; may contain salt acetic acid. equations when necessary (See paragraph or sugar or both, and including (e)(6)(ii) of this section for method to ob- oil-in-water emulsions of low- or tain e′). high-fat content. 3. Aqueous, acid or nonacid prod- Water, n-heptane, 3% If when calculated by the equations in ucts containing free oil or fat; acetic acid. may contain salt, and including paragraphs (e)(6)(i) (a) and (b) of this water-in-oil emulsions of low- or section, the extractives in milligrams high-fat content. per square inch exceed the limitations 4. Dairy products and modifica- prescribed in paragraphs (c) or (d) of tions: Water, n-heptane. this section, proceed to paragraph i. Water-in-oil emulsions, high (e)(6)(ii) of this section (method for de- or low fat. termining the amount of acidified chlo- ii. Oil-in-water emulsions, high roform-soluble extractives residue). or low fat. (ii) Acidified chloroform-soluble extrac- 5. Low moisture fats and oils ...... n-heptane. 6. Beverages: tives residue. Add 3 milliliters of 37 per- i. Containing up to 8% alcohol 8% ethanol/water. cent ACS reagent grade hydrochloric ii. Nonalcoholic ...... 3% acetic acid. acid and 3 milliliters of distilled water iii. Containing more than 8% 50% ethanol/water. to the evaporating dish containing the alcohol. dried and weighed residue, e, obtained 7. Bakery products ...... Water, n-heptane. in paragraph (e)(6)(i) of this section. 8. Dry solids (without free fat or No extraction test re- oil). quired. Mix well so every portion of the residue 9. Dry solids (with free fat or oil) .. n-heptane. is wetted with the hydrochloric acid solution. Then add 50 milliliters of (g) The provisions of paragraphs (c) chloroform. Warm carefully, and filter and (d) of this section are not applica- through Whatman No. 41 filter paper ble to the ionomeric resins that are (or equivalent) in a Pyrex (or equiva- used in food-packaging adhesives com- lent) funnel, collecting the filtrate in a plying with § 175.105 of this chapter. clean separatory funnel. Shake for 1 minute, then draw off the chloroform [45 FR 22916, Apr. 4, 1980, as amended at 49 layer into a clean tared evaporating FR 10108, Mar. 19, 1984; 49 FR 37747, Sept. 26, dish (platinum or Pyrex). Repeat the 1984; 53 FR 44009, Nov. 1, 1988; 54 FR 24898, chloroform extraction, washing the June 12, 1989]

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§ 177.1340 Ethylene-methyl acrylate co- (a) Identity. For the purpose of this polymer resins. section, ethylene/1,3-phenylene oxy- Ethylene-methyl acrylate copolymer ethylene isophthalate/terephthalate copolymer consists of the basic copoly- resins may be safely used as articles or mer produced by the catalytic components of articles intended for use polycondensation of isophthalic acid in contact with food, in accordance and terephthalic acid with ethylene with the following prescribed condi- glycol and 1,3-bis(2- tions: hydroxyethoxy)benzene such that the (a) For the purpose of this section, finished resin contains between 42 and the ethylene-methyl acrylate copoly- 48 mole-percent of isophthalic mer resins consist of basic copolymers moieties, between 2 and 8 mole-percent produced by the copolymerization of of terephthalic moieties, and not more ethylene and methyl acrylate such than 10 mole-percent of 1,3-bis(2- that the copolymers contain no more hydroxyethoxy)benzene moieties. than 25 weight percent of polymer (b) Specifications—(1) Density. Ethyl- units derived from methyl acrylate. ene/1,3-phenylene oxyethylene (b) The finished food-contact article, isophthalate/terephthalate copolymer when extracted with the solvent or sol- identified in paragraph (a) of this sec- vents characterizing the type of food tion has a density of 1.33±0.02 grams per and under the conditions of time and cubic centimeter measured by ASTM temperature characterizing the condi- Method D 1505–85 (Reapproved 1990), tions of its intended use as determined ‘‘Standard Test Method for Density of from tables 1 and 2 of § 176.170(c) of this Plastics by the Density-Gradient Tech- chapter, yields net chloroform-soluble nique,’’ which is incorporated by ref- extractives (corrected for zinc extrac- erence in accordance with 5 U.S.C. tives as zinc oleate) in each extracting 552(a) and 1 CFR part 51. Copies may be solvent not to exceed 0.5 milligram per obtained from the American Society square inch of food-contact surface for Testing and Materials, 1916 Race when tested by the methods described St., Philadelphia, PA 19103, or may be in § 176.170(d) of this chapter. If the fin- examined at the Center for Food Safety ished food-contact article is itself the and Applied Nutrition’s Library, Food subject of a regulation in parts 174, 175, and Drug Administration, 5100 Paint 176, 177, 178 and § 179.45 of this chapter, Branch Pkwy., College Park, MD 20740, it shall also comply with any specifica- and the Office of the Federal Register, tions and limitations prescribed for it 800 North Capitol St. NW., suite 700, by that regulation. Washington, DC. NOTE: In testing the finished food-contact (2) Softening point. Ethylene/1,3–phen- article, use a separate test sample for each ylene oxyethylene isophthalate/ required extracting solvent. terephthalate copolymer identified in (c) The provisions of this section are paragraph (a) of this section has a soft- not applicable to ethylene-methyl ac- ening point of 63±5 °C as measured by rylate copolymer resins used in food- ASTM Method D 1525–87, ‘‘Standard packaging adhesives complying with Test Method for VICAT Softening Tem- § 175.105 of this chapter. perature of Plastics,’’ which is incorporated by reference in accordance § 177.1345 Ethylene/1,3–phenylene oxy- with 5 U.S.C. 552(a) and 1 CFR part 51. ethylene isophthalate/ The availability of this material is pro- terephthalate copolymer. vided in paragraph (b)(1) of this sec- Ethylene/1, 3-phenylene oxyethylene tion. isophthalate/terephthalate copolymer (c) Optional adjuvant substances. (CAS Reg. No. 87365–98–8) identified in Ethylene/1,3–phenylene oxyethylene paragraph (a) of this section may be isophthalate/terephthalate copolymer, safely used, subject to the provisions of identified in paragraph (a) of this sec- this section, as the non-food-contact tion, may contain optional adjuvant layer of laminate structures subject to substances required in their produc- the provisions of § 177.1395, and in tion. The optional adjuvants may in- blends with polyethylene terephthalate clude substances used in accordance polymers complying with § 177.1630. with § 174.5 of this chapter.

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(d) Limitations. Copolymer blends de- (vi) The copolymer of vinylidene flu- scribed above shall not exceed 30 per- oride and hexafluoropropene (CAS Reg. cent by weight of ethylene/1, 3-phen- No. 9011–17–0), containing 65 to 71 per- ylene oxyethylene isophthalate/ cent fluorine and having a Mooney Vis- terephthalate copolymer. The finished cosity of at least 28, for use as a proc- blend may be used in contact with food essing aid at a level not to exceed 0.2 only under conditions of use C through percent by weight of ethylene-vinyl ac- G, as described in table 2 of § 176.170(c) etate copolymers. of this chapter, except that with food (2) Maleic anhydride-grafted ethyl- identified as Type III, IV–A, V, VII–A, ene-vinyl acetate copolymers (CAS and IX in § 176.170(c), table 1, the co- Reg. No. 28064–24–6) consist of basic res- polymer may be used under condition ins produced by the catalytic copolym- of use C at temperatures not to exceed erization of ethylene and vinyl acetate, 160 °F (71 °C). followed by reaction with maleic anhy- [57 FR 43399, Sept. 21, 1992, as amended at 59 dride. Such polymers shall contain not FR 62318, Dec. 5, 1994; 61 FR 14481, Apr. 2, more than 11 percent of polymer units 1996; 62 FR 34628, June 27, 1997] derived from vinyl acetate by weight of total polymer prior to reaction with § 177.1350 Ethylene-vinyl acetate co- maleic anhydride, and not more than 2 polymers. percent of grafted maleic anhydride by Ethylene-vinyl acetate copolymers weight of the finished polymer. Op- may be safely used as articles or com- tional adjuvant substances that may be ponents of articles intended for use in added to the copolymers include sub- producing, manufacturing, packing, stances generally recognized as safe in processing, preparing, treating, pack- food and food packaging, substances aging, transporting, or holding food in the use of which is permitted under ap- accordance with the following pre- plicable regulations in parts 170 scribed conditions: through 189 of this chapter, and sub- (a)(1) Ethylene-vinyl acetate copoly- stances identified in § 175.300(b)(3)(xxv), mers consist of basic resins produced (xxvii), (xxxiii), and (xxx) of this chap- by the catalytic copolymerization of ter and colorants for polymers used in ethylene and vinyl acetate to which accordance with the provisions of may have been added certain optional § 178.3297 of this chapter. substances to impart desired techno- (b)(1) Ethylene-vinyl acetate copoly- logical or physical properties to the mers, with or without the optional sub- resin. Subject to any limitations pre- stances described in paragraph (a) of scribed in this section, the optional this section, when extracted with the substances may include: solvent or solvents characterizing the (i) Substances generally recognized type of food, and under conditions of as safe in food and food packaging. time and temperature characterizing (ii) Substances the use of which is the conditions of their intended use as permitted under applicable regulations determined from tables 1 and 2 of in parts 170 through 189 of this chapter, § 176.170(c) of this chapter, shall yield prior sanction, or approvals. net chloroform-soluble extractives cor- (iii) Substances identified in rected for zinc as zinc oleate not to ex- § 175.300(b)(3) (xxv), (xxvii), (xxx), and ceed 0.5 milligram per square inch of an (xxxiii) of this chapter, and colorants appropriate sample. used in accordance with § 178.3297 of (2) Maleic anhydride grafted ethyl- this chapter. ene-vinyl acetate copolymers shall (iv) Erucamide as identified in have a melt flow index not to exceed 2.1 § 178.3860 of this chapter. grams per 10 minutes as determined by (v) Xanthan gum as identified in ASTM method D 1238–82, ‘‘Standard § 172.695 for use as a thickening agent Test Method for Flow Rates of Thermo- at a level not to exceed 1 percent by plastics by Extrusion Plastometer,’’ weight of coating solids in aqueous dis- which is incorporated by reference in persions of ethylene-vinyl acetate co- accordance with 5 U.S.C. 552(a). Copies polymers, where such copolymers are may be obtained from the American used only as coatings or a component Society for Testing Materials, 1916 of coatings. Race St., Philadelphia, PA 19103, or at

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the Division of Petition Control (HFS– growth of microorganisms under the 215), Center for Food Safety and Ap- following conditions: plied Nutrition, Food and Drug Admin- (1) Gamma photons emitted from a istration, 5100 Paint Branch Pkwy., cobalt–60 sealed source in the dose College Park, MD 20740, or may be ex- range of 5–50 kiloGray (0.5–5.0 amined at the Center for Food Safety megarads). and Applied Nutrition’s Library, 5100 (2) The irradiated ethylene-vinyl ace- Paint Branch Pkwy., College Park, MD tate copolymer films, when extracted 20740, or at the Office of the Federal with reagent grade n-heptane (freshly Register, 800 North Capitol St. NW., redistilled before use) according to suite 700, Washington, DC. Compliance methods described under § 176.170(d)(3) of the melt flow index specification of this chapter, at 75 °F for 30 minutes shall be determined using conditions shall yield total extractives not to ex- and procedures corresponding to those ceed 4.5 percent by weight of the film. described in the method as Condition E, Procedure A). The copolymers shall [42 FR 14572, Mar. 15, 1977, as amended at 43 be used in blends with other polymers FR 29287, July 7, 1978; 54 FR 35874, Aug. 30, at levels not to exceed 17 percent by 1989; 55 FR 18595, May 3, 1990; 56 FR 42932, Aug. 30, 1991; 64 FR 47108, Aug. 30, 1999] weight of total polymer, subject to the limitation that when contacting food § 177.1360 Ethylene-vinyl acetate-vinyl of types III, IV–A, V, VI–C, VII–A, and alcohol copolymers. IX, identified in § 176.170(c) of this chapter, Table 1, the polymers shall be used Ethylene-vinyl acetate-vinyl alcohol only under conditions of use C, D, E, F, copolymers (CAS Reg. No. 26221–27–2) and G, described in § 176.170(c) of this may be safely used as articles or com- chapter, Table 2. ponents of articles intended for use in (c) The provisions of paragraph (b) of contact with food, in accordance with this section are not applicable to ethyl- the following prescribed conditions: ene-vinyl acetate copolymers used in (a) Ethylene-vinyl acetate-vinyl alco- food-packaging adhesives complying hol copolymers are produced by the with § 175.105 of this chapter. partial or complete alcoholysis or hy- (d) Ethylene-vinyl acetate copoly- drolysis of those ethylene-vinyl acetate mers may be irradiated under the fol- copolymers complying with § 177.1350. lowing conditions to produce molecular (1) Those copolymers containing a crosslinking of the polymers to impart minimum of 55 percent ethylene and a desired properties such as increased maximum of 30 percent vinyl alcohol strength and increased ability to units by weight may be used in contact shrink when exposed to heat: with foods as described in paragraph (b) (1) Electron beam source of ionizing of this section. radiation at a maximum energy of 3 (2) Those copolymers containing a million electron volts: Maximum ab- minimum of 55 percent ethylene and a sorbed dose not to exceed 150 kiloGray maximum of 15 percent vinyl alcohol (15 megarads). units by weight may be used in contact (2) The finished food-contact film with foods as described in paragraph (c) shall meet the extractives limitations of this section. prescribed in paragraph (e)(2) of this (3) Those copolymers containing 17 to section. 40 percent ethylene and 60 to 83 percent (3) The ethylene-vinyl acetate co- vinyl alcohol units by weight may be polymer films may be further irradi- used in contact with foods as described ated in accordance with the provisions in paragraph (d) of this section. of paragraph (e)(1) of this section: Pro- (b) The finished food-contact article vided, That the total accumulated radi- shall not exceed 0.013 centimeter (0.005 ation dose from both electron beam inch) thickness and shall contact foods and gamma ray radiation does not ex- only of the types identified in table 1 of ceed 150 kiloGray (15 megarads). § 176.170(c) of this chapter in Categories (e) Ethylene-vinyl acetate copolymer I, II, IV–B, VI, VII–B, and VIII under films intended for contact with food conditions of use D through G de- may be irradiated to control the scribed in table 2 of § 176.170(c) of this

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chapter. Film samples of 0.013 centi- table 2 of § 176.170(c) of this chapter. meter (0.005) inch thickness rep- Film samples of 0.018 centimeter (0.007 resenting the finished article shall inch) thickness representing the fin- meet the following extractive limita- ished articles shall meet the following tion when tested by ASTM method extractive limitation when tested by F34–76 (Reapproved 1980), ‘‘Standard ASTM method F34–76 (Reapproved Test Method for Liquid Extraction of 1980), ‘‘Standard Test Methods for Liq- Flexible Barrier Materials,’’ which is uid Extraction of Flexible Barrier Ma- incorporated by reference. Copies may terials,’’ which is incorporated by ref- be obtained from the American Society erence. The availability of this incor- for Testing Materials, 1916 Race St., poration by reference is given in para- Philadelphia, PA 19103, or may be ex- graph (b) of this section. The film when amined at the Office of the Federal extracted with distilled water at 100 °C Register, 800 North Capitol Street, (212 °F) for 30 minutes yields ethylene- NW., suite 700, Washington, DC 20408. vinyl acetate-vinyl alcohol oligomers (1) The film when extracted with dis- not to exceed 0.093 milligram per tilled water at 21 °C (70 °F) for 48 hours square centimeter (0.6 milligram per yields total extractives not to exceed square inch) of food contact surface as 0.0047 milligram per square centimeter determined by a method entitled ‘‘An- (0.03 milligram per square inch) of alytical Method of Determining the food-contact surface. Amount of EVOH in the Extractives (2) The film when extracted with 50 Residue of EVOH Film,’’ dated March percent ethyl alcohol at 21 °C (70 °F) for 23, 1987, as developed by the Kuraray 48 hours yields total extractives not to Co., Ltd., which is incorporated by ref- exceed 0.0062 milligram per square cen- erence in accordance with 5 U.S.C. timeter (0.04 milligram per square 552(a) and 1 CFR part 51. Copies may be inch) of food-contact surface. obtained from the Office of Premarket (c) The finished food-contact article Approval (HFS–200), Center for Food shall not exceed 0.0076 centimeter (0.003 Safety and Applied Nutrition, Food and inch) thickness and shall contact foods Drug Administration, 5100 Paint only of the types identified in table 1 of Branch Pkwy., College Park, MD 20740, § 176.170(c) of this chapter in Categories or may be examined at the Center for III, IV–A, VII–A, and IX under condi- Food Safety and Applied Nutrition’s tions of use F and G described in table Library, 5100 Paint Branch Pkwy., Col- 2 of § 176.170(c) of this chapter. Film lege Park, MD 20740, or at the Office of samples of 0.0076 centimeter (0.003 inch) the Federal Register, 800 North Capitol thickness representing the finished ar- St. NW., suite 700, Washington, DC. ticles shall meet the following extrac- (e) The provisions of this section are tive limitation when tested by ASTM not applicable to ethylene-vinyl ace- method F34–76 (Reapproved 1980), tate-vinyl alcohol copolymers used in ‘‘Standard Test Method for Liquid Ex- the food-packaging adhesives com- traction of Flexible Barrier Materials,’’ plying with § 175.105 of this chapter. which is incorporated by reference. The availability of this incorporation by [47 FR 41531, Sept. 21, 1982, as amended at 49 reference is given in paragraph (b) of FR 10108, Mar. 19, 1984; 65 FR 17135, Mar. 31, this section. The film when extracted 2000] with n-heptane at 38 °C (100 °F) for 30 § 177.1380 Fluorocarbon resins. minutes yields total extractives not to exceed 0.0078 milligram per square cen- Fluorocarbon resins may be safely timeter (0.05 milligram per square used as articles or components of arti- inch) of food-contact surface, after cor- cles intended for use in contact with recting the total extractives by divid- food, in accordance with the following ing by a factor of five. prescribed conditions: (d) The finished food-contact article (a) For the purpose of this section, shall not exceed 0.018 centimeter (0.007 fluorocarbon resins consist of basic res- inch) thickness and may contact all ins produced as follows: foods, except those containing more (1) Chlorotrifluoroethylene resins than 8 percent alcohol, under condi- produced by the homopolymerization tions of use B through H described in of chlorotrifluoroethylene.

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(2) Chlorotrifluoroethylene-1,1- articles or components of articles that difluoroethylene copolymer resins pro- are intended for repeated use in con- duced by copolymerization of tact with food. chlorotrifluoroethylene and 1,1- (3) In accordance with current good difluoroethylene. manufacturing practice, those food- (3) Chlorotrifluoroethylene-1,1- contact articles intended for repeated difluoroethylene-tetrafluoroethylene use shall be thoroughly cleansed prior co-polymer resins produced by co- to their first use in contact with food. polymerization of (c) Extractives limitations are appli- chlorotrifluoroethylene, 1,1- cable to the basic resins in the form of difluoroethylene, and tetrafluoro- pellets that have been ground or cut ethylene. into small particles that will pass (4) Ethylene-chlorotrifluoroethylene through a U.S. Standard Sieve No. 6 copolymer resins produced by copolym- and that will be held on a U.S. Stand- erization of nominally 50 mole percent ard Sieve No. 10. of ethylene and 50 mole percent of (1) A 100-gram sample of the resin chlorotrifluoroethylene. The copoly- pellets, when extracted with 100 milli- mer shall have a melting point of 239 to liters of distilled water at reflux tem- ° 243 C and a melt index of less than or perature for 8 hours, shall yield total equal to 20 as determined by ASTM extractives not to exceed 0.003 percent Method D 3275–89 ‘‘Standard Specifica- by weight of the resins. tion for E–CTFE–Fluoroplastic Mold- (2) A 100-gram sample of the resin ing, Extrusion, and Coating Mate- pellets, when extracted with 100 milli- rials,’’ which is incorporated by ref- liters of 50 percent (by volume) ethyl erence in accordance with 5 U.S.C. alcohol in distilled water at reflux 552(a) and 1 CFR part 51. Copies may be temperature for 8 hours, shall yield obtained from the American Society total extractives not to exceed 0.003 for Testing and Materials, 1916 Race percent by weight of the resins. St., Philadelphia, PA 19013, or may be (3) A 100-gram sample of the resin examined at the Office of the Federal pellets, when extracted with 100 milli- Register, 800 North Capitol Street, liters of n-heptane at reflux tempera- NW., suite 700, Washington, DC. ture for 8 hours, shall yield total ex- (b) Fluorocarbon resins that are iden- tractives not to exceed 0.01 percent by tified in paragraph (a) of this section weight of the resins. and that comply with extractive limitations prescribed in paragraph (c) of [42 FR 14572, Mar. 15, 1977, as amended at 57 this section may be used as articles or FR 185, Jan. 3, 1992] components of articles intended for use in contact with food as follows: § 177.1390 Laminate structures for use ≥ (1) Fluorocarbon resins that are iden- at temperatures of 250 F and tified in paragraphs (a)(1), (a)(2), and above. (a)(3) of this section and that comply (a) The high-temperature laminates only with the extractive limitations identified in this section may be safely prescribed in paragraphs (c)(1) and used for food contact at temperatures (c)(2) of this section may be used when not exceeding 135 °C (275 °F) unless oth- such use is limited to articles or com- erwise specified. These articles are lay- ponents of articles that are intended ered constructions that are optionally for repeated use in contact with food or bonded with adhesives. The interior that are intended for one-time use in (food-contact) layer(s) may be sepa- contact with foods only of the types rated from the exterior layer(s) by a identified in § 176.170(c) of this chapter, functional barrier, such as aluminum table 1, under Types I, II, VI, VII–B, foil. Upon review of the physical prop- and VIII. erties of a particular construction, the (2) Fluorocarbon resins that are iden- Food and Drug Administration may tified in paragraph (a)(4) of this section consider other layers to serve as func- and that comply with the extractive tional barriers. This regulation is not limitations prescribed in paragraphs intended to limit these constructions (c)(1) and (c)(2) of this section may be as to shape, degree of flexibility, thick- used only when such use is limited to ness, or number of layers. These layers

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may be laminated, extruded, co- thorized food-contact materials yield extruded, or fused. no more than 0.15 milligrams of epsilon- (b) When containers subject to this caprolactam and 0.04 milligrams of regulation undergo heat sterilization omega-laurolactam per square inch to produce shelf-stable foods, certain when extracted with 95 percent ethanol control measures (in addition to the at 121 °C (250 °F) for 2 hours. food additive requirements in para- (g) Polymeric resins that comply graphs (c) and (d) of this section) are with an applicable regulation in this necessary to ensure proper food steri- chapter which permits food type and lization and package integrity. Refer time/temperature conditions to which to parts 108, 110, 113, and 114 of this the container will be exposed, includ- chapter for details. ing sterilization processing. (c) Subject to the provisions of this (ii) Adjuvants used in these layers paragraph, food-contact articles pro- must comply with an applicable regu- duced from high-temperature lami- lation that permits food type and time/ nates may be safely used to package all temperature conditions to which the food types except those containing container will be exposed, including more than 8 percent ethyl alcohol. sterilization processing. (1) Polymeric films/layers. Films or lay- (2) Adhesives. The use of adhesives in ers not separated from food by a func- these containers is optional. Adhesives tional barrier must meet the following may be formulated from the following requirements: substances, subject to the prescribed (i) Films/layers may consist of the limitations: following: (i) Any substance suitable for use in (a) Polyolefin resins complying with formulating adhesives that complies item 2.2 or 3.2 of the table in with an applicable regulation of this § 177.1520(c). chapter which permits food type and (b) Polymeric resin blends formu- time/temperature conditions to which lated from a base polymer complying the container will be exposed, includ- with item 2.2 or 3.2 of the table in ing sterilization processing. § 177.1520(c) blended with no more than (ii) Substances complying with 10 percent by weight of a copolymer of § 175.105 of this chapter may be used in ethylene and vinyl acetate complying these constructions, provided they are with § 177.1350. separated from the interior (food-con- (c) Polymeric resin blends formulated tact) layer(s) by a functional barrier as from a base polymer complying with discussed under paragraph (a) of this item 2.2 or 3.2 of the table in section. § 177.1520(c) blended with no more than (iii) Maleic anhydride adduct of poly- 38 percent by weight of a homopolymer propylene complying with § 175.300 of of isobutylene complying with this chapter. § 177.1420(a)(1). (iv) Polyester-urethane adhesive for (d) Polyethylene phthalate resins use at temperatures not exceeding 121 complying with § 177.1630(e)(4) (i) and °C (250 °F) and formulated from the fol- (ii). lowing: (e) Nylon MXD–6 resins that comply (a) Polyester-urethanediol resin pre- with item 10.3 of the table in pared by the reaction of a mixture of § 177.1500(b) of this chapter when ex- polybasic acids and polyhydric alcohols tracted with water and heptane under listed in § 175.300(b)(3)(vii) of this chap- the conditions of time and temperature ter, 3-isocyanatomethyl-3,5,5- specified for condition of use A, as set trimethylcyclohexyl isocyanate (CAS forth in Table 2 of § 176.170(c) of this Reg. No. 4098–71–9) and optional chapter. trimethoxysilane coupling agents con- (f) Nylon 6⁄12 resins (CAS Reg. No. taining amino, epoxy, ether, and/or 25191–04–2) complying with item 13.3 of mercapto groups not to exceed 3 per- the table in § 177.1500(b), for use as cent by weight of the cured adhesive. nonfood-contact layers of laminated (b) Urethane cross-linking agent films and in rigid multilaminate con- comprising not more than 25 percent structions with polypropylene outer by weight of the cured adhesive and layers. Laminate structures with au- formulated from 3-isocyanatomethyl-

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3,5,5-trimethylcyclohexyl isocyanate bis(isocyanatomethyl)benzene (CAS (CAS Reg. No. 4098–71–9) adduct of Reg. No. 25854–16–4). trimethylol propane (Cas Reg. No. 77– (vii) Polyester-polyurethane resin- 99–6) and/or 1,3-bis(isocyanatomethyl) acid dianhydride adhesives for use at benzene (CAS Reg. No. 25854–16–4) temperatures not to exceed 121 °C (250 adduct of trimethylol propane. °F), in contact only with food Types I, (v) Polyester-epoxy-urethane adhe- II, VIA, VIB, VIIB, and VIII as de- sives formulated from the following: scribed in Table I of § 176.170 of this (a) Polyester resin formed by the re- chapter, and formulated from the fol- action of polybasic acids and lowing mixture: polyhydric alcohols listed in (a)(1) Polyesterpolyurethanediol res- § 175.300(b)(3)(vii) of this chapter. Aze- ins prepared by the reaction of a mix- laic acid may also be used as a ture of polybasic acids and polyhydric polybasic acid. alcohols listed in § 175.300(b)(3)(vii) of (b) Epoxy resin listed in this chapter and 3-isocyanatomethyl- § 175.300(b)(3)(viii)(a) of this chapter and 3,5,5-trimethylcyclohexyl isocyanate comprising no more than 30 percent by (CAS Reg. No. 4098–71–9). Additionally, weight of the cured adhesive. dimethylol propionic acid and 1,6- hexanediol may be used alone or in (c) Urethane cross-linking agent com- combination as reactants in lieu of a prising no more than 14 percent weight polybasic acid and a polyhydric alco- of the cured adhesive and formulated hol. from 3-isocyanatomethyl-3,5.5- (2) Acid dianhydride formulated from trimethylcyclohexyl isocyanate 3a,4,5,7a-tetrahydro-7-methyl-5- cyanurate (CAS Reg. No. 53880–05–0). (tetrahydro-2,5-dioxo-3-furanyl)-1,3- (vi) Polyurethane-polyester resin- isobenzofurandione (CAS Reg. No. epoxy adhesives formulated from the 73003–90–4), comprising not more than following mixture: one percent of the cured adhesive. (a)(1) Polyester-polyurethanediol res- (b) Urethane cross-linking agent, ins prepared by the reaction of a mix- comprising not more than twelve per- ture of polybasic acids and polyhydric cent by weight of the cured adhesive, alcohols listed in § 175.300(b)(3)(vii) of and formulated from trimethylol pro- this chapter and 3-isocyanatomethyl- pane (CAS Reg. No. 77–99–6) adducts of 3,5,5-trimethylcyclohexyl isocyanate 3-isocyanatomethyl-3,5,5- (CAS Reg. No. 4098–71–9). trimethylcyclohexyl isocyanate (CAS (2) Polyester resin formed by the re- Reg. No. 4098–71–9) and/or 1,3- action of polybasic acids and bis(isocyanatomethyl)benzene (CAS polyhydric alcohols listed in Reg. No. 363–48–31). § 175.300(b)(3)(vii) of this chapter. Addi- (3) Test specifications. These specifica- tionally, azelaic acid and 1,6- tions apply only to materials on the hexanediol may also be used as food-contact side of a functional bar- reactants in lieu of a polyhydric alco- rier, if present. All tests must be per- hol. formed on containers made under pro- (3) Epoxy resin listed in duction conditions. Laminated struc- § 175.300(b)(3)(viii)(a) of this chapter and tures submitted to extraction proce- comprising not more than 5 percent by dures must maintain complete struc- weight of the cured adhesive. tural integrity (particularly with re- (4) Optional trimethoxy silane curing gard to delamination) throughout the agents, containing amino, epoxy, ether, test. or mercapto groups not in excess of 3 (i) Nonvolatile extractives. (a) For use percent of the cured adhesive. at temperatures not to exceed 121 °C (b) Urethane cross-linking agent, (250 °F): The container interior (food- comprising not more than 20 percent contact side) shall be extracted with by weight of the cured adhesive, and deionized distilled water at 121 °C (250 formulated from trimethylol propane °F) for 2 hours. (CAS Reg. No. 77–99–6) adducts of 3– (1) The chloroform-soluble fraction of isocyanatomethyl–3,5,5– the total nonvolatile extractives for trimethylcyclohexyl isocyanate (CAS containers using adhesives listed in Reg. No. 4098–71–9) or 1,3- paragraphs (c)(2)(i), (c)(2)(ii), (c)(2)(iii),

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(c)(2)(iv), and (c)(2)(vii) of this section Pouch Water Extracts,’’ which is incor- shall not exceed 0.0016 milligram per porated by reference. The availability square centimeter (0.01 milligram per of this incorporation by reference is square inch) as determined by a meth- given in paragraph (c)(3)(i)(a)(1) of this od entitled ‘‘Determination of Non- section. Volatile Chloroform Soluble Residues (3) The chloroform-soluble fraction of in Retort Pouch Water Extracts,’’ the total nonvolatile extractives for which is incorporated by reference. containers using adhesives listed in Copies are available from the Center paragraph (c)(2)(vi) of this section shall for Food Safety and Applied Nutrition not exceed 0.008 milligram per square (HFS–200), Food and Drug Administra- centimeter (0.05 milligram per square tion, 5100 Paint Branch Pkwy., College inch) as determined by a method enti- Park, MD 20740, and may be examined tled, ‘‘Determination of Non-volatile at the Center for Food Safety and Ap- Chloroform Soluble Residues in Retort plied Nutrition’s Library, 5100 Paint Pouch Water Extracts,’’ which is incor- Branch Pkwy., College Park, MD 20740, porated by reference in paragraph or at the Office of the Federal Register, (c)(3)(i)(a)(1) of this section. 800 North Capitol St. NW., suite 700, (ii) Volatiles. Volatile substances em- Washington, DC 20408. ployed in the manufacture of high-tem- (2) The chloroform-soluble fraction of perature laminates must be removed to the total nonvolatile extractives for the greatest extent possible in keeping containers using adhesives listed in with good manufacturing practice pre- paragraph (c)(2)(v) of this section shall scribed in § 174.5(a) of this chapter. not exceed 0.016 milligram per square (d) Nylon 12/aluminum foil high-tem- centimeter (0.10 milligram per square perature laminates: Subject to the pro- inch) as determined by a method titled visions of this paragraph, containers ‘‘Determination of Non-volatile Chlo- constructed of nylon 12 laminated to roform Soluble Residues in Retort aluminum foil may be safely used at ° Pouch Water Extracts,’’ which is incor- temperatures no greater than 250 F ° porated by reference in paragraph (121 C) in contact with all food types (c)(3)(i)(a)(1) of this section. except those containing more than 8 (b) For use at temperatures not to ex- percent alcohol. ceed 135 °C (275 °F): The container inte- (1) The container is constructed of rior (food-contact side) shall be ex- aluminum foil to which nylon 12 film is tracted with deionized distilled water fused. Prior to fusing the nylon 12, the at 135 °C (275 °F) for 1 hour. aluminum foil may be optionally precoated with a coating complying (1) The chloroform-soluble fraction of with § 175.300 of this chapter. the total nonvolatile extractives for (2) Nylon 12 resin complying with containers using no adhesive, or adhe- § 177.1500 and having an average thick- sives listed in paragraphs (c)(2) (i), (ii), ness not to exceed 0.0016 inch (41 mi- and (iii) of this section shall not exceed crons) may be used as the food-contact 0.0020 milligram per square centimeter surface of the container. (0.013 milligram per square inch) as de- (3) Container test specifications. On termined by a method titled ‘‘Deter- exposure to distilled water at 250 °F mination of Non-volatile Chloroform (121 °C) for 2 hours, extractives from Soluble Residues in Retort Pouch the food-contact side of the nylon 12 Water Extracts,’’ which is incorporated multilayered construction shall not ex- by reference. The availability of this ceed 0.05 milligram per square inch incorporation by reference is given in (0.0078 milligram per square centi- paragraph (c)(3)(i)(a)(1) of this section. meter) as total nonvolatile extractives. (2) The chloroform-soluble fraction of the total nonvolatile extractives for [45 FR 2843, Jan. 15, 1980, as amended at 47 containers using adhesives listed in FR 49639, Nov. 2, 1982; 48 FR 236, Jan. 4, 1983; paragraph (c)(2)(v) of this section shall 48 FR 15242, Apr. 8, 1983; 48 FR 17347, Apr. 22, not exceed 0.016 milligram per square 1983; 49 FR 7558, Mar. 1, 1984; 52 FR 33575, Sept. 4, 1987; 53 FR 39084, Oct. 5, 1988; 54 FR centimeter (0.10 milligram per square 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996; inch) as determined by a method titled 63 FR 55943, Oct. 20, 1998; 64 FR 4785, Feb. 1, ‘‘Determination of Non-volatile Chlo- 1999; 64 FR 46272, Aug. 25, 1999; 69 FR 15668, roform Soluble Residues in Retort Mar. 26, 2004]

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§ 177.1395 Laminate structures for use Substances Limitations at temperatures between 120 ≥F and ≥ Nylon 6/66 resins complying For use only with: 250 F. with § 177.1500(b), item 4.2 1. Nonalcoholic foods at (a) The laminates identified in this of this chapter (CAS Reg. temperatures not to ex- 24993–04–2). ceed 82.2 °C (180 °F). section may be safely used at the speci- Laminate structures with fied temperatures. These articles are authorized food-contact layered structures that are optionally materials yield no more than 0.15 milligram of ep- bonded with adhesives. In these arti- silon-caprolactam per cles, the food-contact layer does not square inch when ex- function as a barrier to migration of tracted with water at 82.2 °C (180 °F) for 5 hours. components from non-food-contact lay- 2. Nonalcoholic foods at ers. The layers may be laminated, ex- temperatures not to ex- ° ° truded, coextruded, or fused. ceed 100 C (212 F). Laminate films with au- (b) Laminate structures may be man- thorized food-contact ma- ufactured from: terials yield no more than 0.15 milligram of epsilon- (1) Polymers and adjuvants com- caprolactam per square plying with § 177.1390 of this chapter. inch when extracted with (2) Any polymeric resin listed in water at 100 °C (212 °F) for 5 hours. these regulations so long as the use of Nylon 6/69 resins complying For use with nonalcoholic the resin in the structure complies with § 177.1500(b), item 14, foods under conditions of with the conditions of use (food type of this chapter (CAS Reg. use B, C, D, E, F, G, and No. 51995–62–1). H described in table 2 of and time/temperature) specified in the § 176.170 of this chapter. regulation for that resin. Laminate structures with (3) Optional adjuvant substances used authorized food-contact materials may contain in accordance with § 174.5 of this chap- nylon 6/69 resins pro- ter. vided that the nitrogen content of aqueous ex- (4) The following substances in non- tracts of a representative food-contact layers only: laminate (obtained at 100 °C (212 °F) for 8 hours) Substances Limitations does not exceed 15 micrograms per square Ethylene/1,3–phenylene oxy- For use only with poly- centimeter (100 ethylene isophthalate/ ethylene terephthalate as micrograms per square terephthalate copolymer the food-contact layer, inch). (CAS Reg. No. 87365–98–8) complying with complying with § 177.1345. § 177.1630 under conditions of use C through G [52 FR 33575, Sept. 4, 1987, as amended at 53 described in table 2 of FR 19772, May 31, 1988; 57 FR 43399, Sept. 21, § 176.170(c) of this chap- 1992; 58 FR 32610, June 11, 1993; 62 FR 53957, ter. Laminate structures, Oct. 17, 1997] when extracted with 8 percent ethanol at 150 °F § 177.1400 Hydroxyethyl cellulose film, for 2 hours shall not yield water-insoluble. m-pheny lenedioxy-O,O′- diethyl isophthalate or cy- Water-insoluble hydroxyethyl cel- clic bis(ethylene lulose film may be safely used for isophthalate) in excess of 7.8 micrograms/square packaging food in accordance with the decimeter (0.5 following prescribed conditions: microgram/square inch) of (a) Water-insoluble hydroxyethyl cel- food-contact surface. lulose film consists of a base sheet Nylon 6/12 resins complying For use with nonalcoholic with § 177.1500(b), item foods at temperatures not manufactured by the ethoxylation of 13.2, of this chapter (CAS to exceed 100 °C (212 cellulose under controlled conditions, Reg. No. 25191–04–2). °F). Laminate structures to which may be added certain optional with authorized food-con- substances of a grade of purity suitable tact materials yield no more than 0.15 milligram for use in food packaging as constitu- of epsilon-caprolactam ents of the base sheet or as coatings and 0.04 milligram of applied to impart desired technological omega-laurolactam per square inch when ex- properties. tracted with water at 100 (b) Subject to any limitations pre- °C (212 °F) for 5 hours. scribed in parts 170 through 189 of this chapter, the optional substances used

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in the base sheet and coating may in- molar percent of isoprene such that the clude: finished polymers have a molecular (1) Substances generally recognized weight of 300,000 (Flory) or higher. as safe in food. (3) Chlorinated isobutylene-isoprene (2) Substances permitted to be used copolymers produced when in water-insoluble hydroxyethyl cel- isobutylene-isoprene copolymers (mo- lulose film by prior sanction or ap- lecular weight 300,000 (Flory) or higher) proval and under conditions specified are modified by chlorination with not in such sanctions or approval, and sub- more than 1.3 weight-percent of chlo- stances listed in part 181, subpart B of rine. this chapter. (b) The polymers identified in para- (3) Substances that by any regulation graph (a) of this section may contain promulgated under section 409 of the optional adjuvant substances required act may be safely used as components in the production of the polymers. The of water-insoluble hydroxyethyl cel- optional adjuvant substances required lulose film. in the production of the polymers may (4) Substances identified in and used include substances generally recog- in compliance with § 177.1200(c). nized as safe in food, substances used in (c) Any substance employed in the accordance with a prior sanction or ap- production of the water-insoluble hy- proval, and aluminum chloride. droxyethyl cellulose film described in (c) The provisions of this section are this section that is the subject of a reg- not applicable to polyisobutylene used ulation in parts 174, 175, 176, 177, 178 in food-packaging adhesives complying and § 179.45 of this chapter conforms with § 175.105 of this chapter. with any specification in such regulation. § 177.1430 Isobutylene-butene copolymers. § 177.1420 Isobutylene polymers. Isobutylene-butene copolymers iden- Isobutylene polymers may be safely tified in paragraph (a) of this section used as components of articles in- may be safely used as components of tended for use in producing, manufac- articles intended for use in contact turing, packing, processing, preparing, with food, subject to the provisions of treating, packaging, transporting, or this section. holding food, in accordance with the (a) For the purpose of this section, following prescribed conditions: isobutylene-butene copolymers consist (a) For the purpose of this section, of basic copolymers produced by the isobutylene polymers are those pro- copolymerization of isobutylene with duced as follows: mixtures of n-butenes such that the (1) Polyisobutylene produced by the finished basic copolymers contain not homopolymerization of isobutylene less than 45 weight percent of polymer such that the finished polymers have a units derived from isobutylene and molecular weight of 750,000 (Flory) or meet the specifications prescribed in higher. paragraph (b) of this section when test- (2) Isobutylene-isoprene copolymers ed by the methods described in para- produced by the copolymerization of graph (c) of this section. isobutylene with not more than 3 (b) Specifications:

Maximum Isobutylene-butene copolymers Molecular Viscosity (range) bromine weight (range) value

1. Used as release agents in petroleum wax complying with 300 to 5,000 ... 40 to 20,000 seconds 40 § 178.3710 of this chapter. Saybolt at 200 °F. 2. Used as plasticizers in polyethylene or polypropylene complying 300 to 5,000 ... 40 to 20,000 seconds 40 with § 177.1520, and in polystyrene complying with § 177.1640. Saybolt at 200 °F. 3. Used as components of nonfood articles complying with 300 to 5,000 ... 40 to 20,000 seconds 40 §§ 175.300, 176.170, 176.210, 177.2260(d)(2), 177.2800, and Saybolt at 200 °F. 178.3570 (provided that addition to food does not exceed 10 parts per million), or § 176.180 of this chapter. 4. Used as production aids in the manufacture of expanded 150 to 5,000 ... Less than 20,000 seconds 90. (foamed) polystyrene articles complying with § 177.1640 of this Saybolt at 200 °F. chapter.

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Maximum Isobutylene-butene copolymers Molecular Viscosity (range) bromine weight (range) value

5. Used in release coatings on backings or linings for pressure-sen- 150 to 5,000 ... Less than 20,000 seconds 90 sitive adhesive labels complying with § 175.125 of this chapter. Saybolt at 200 °F.

(c) The analytical methods for deter- preparing, treating, packaging, trans- mining whether isobutylene-butene co- porting, or holding food in accordance polymers conform to the specifications with the following prescribed condi- in paragraph (b) are as follows: tions: (1) Molecular weight. Molecular (a) 4,4′-Isopropylidenediphenol-ep- weight shall be determined by Amer- ichlorohydrin resins consist of basic ican Society for Testing and Materials resins produced by the condensation of (ASTM) method D2503–82, ‘‘Standard equimolar amounts of 4,4′- Test Method for Molecular Weight isopropylidenediphenol and (Relative Molecular Mass) of Hydro- epichlorohydrin terminated with phe- carbons by Thermoelectric Measure- nol, to which may have been added cer- ment of Vapor Pressure,’’ which is in- tain optional adjuvant substances re- corporated by reference. Copies may be quired in the production of the resins. obtained from the American Society (b) The optional adjuvant substances for Testing Materials, 1916 Race St., required in the production of the resins Philadelphia, PA 19103, or may be ex- may include substances generally rec- amined at the Office of the Federal ognized as safe in food, substances used Register, 800 North Capitol Street, in accordance with a prior sanction or NW., suite 700, Washington, DC 20408. approval, and the following: (2) Viscosity. Viscosity shall be determined by ASTM method D445–74, ‘‘Test List of substances Limitations for Kinematic Viscosity of Transparent Butyl alcohol ...... Not to exceed 300 p.p.m. as re- and Opaque Liquids,’’ which is incor- sidual solvent in finished resin. porated by reference. The availability Ethyl alcohol. of this incorporation by reference is Toluene ...... Not to exceed 1,000 p.p.m. as re- given in paragraph (c)(1) of this sec- sidual solvent in finished resin. tion. (3) Maximum bromine value. Maximum (c) 4,4′-Isopropylidenediphenol-ep- bromine value shall be determined by ichlorohydrin resins shall meet the fol- ASTM method D1492–78, ‘‘Standard lowing nonvolatile extractives limita- Test Method for Bromine Index of Aro- tions: matic Hydrocarbons by Coulometric (1) Maximum extractable nonvolatile Titration,’’ which is incorporated by fraction of 2 parts per million when ex- reference. The availability of this in- tracted with distilled water at 70 °C for corporation by reference is given in 2 hours, using a volume-to-surface paragraph (c)(1) of this section. ratio of 2 milliliters per square inch. (d) The provisions of this section are (2) Maximum extractable nonvolatile not applicable to isobutylene-butene fraction of 3 parts per million when ex- copolymers used as provided under tracted with n-heptane at 70 °C for 2 § 175.105 of this chapter. hours, using a volume-to-surface ratio of 2 milliliters per square inch. [52 FR 11641, Apr. 10, 1987, as amended at 63 FR 36175, July 2, 1998] (3) Maximum extractable nonvolatile fraction of 6 parts per million when ex- § 177.1440 4,4′-Isopropylidenediphenol- tracted with 10 percent (by volume) epichlorohydrin resins minimum ethyl alcohol in distilled water at 70 °C molecular weight 10,000. for 2 hours, using a volume-to-surface 4,4′-Isopropylidenediphenol-epichlo- ratio of 2 milliliters per square inch. rohydrin resins having a minimum mo- (d) The provisions of this section are lecular weight of 10,000 may be safely not applicable to 4,4′-isopropylidene- used as articles or components of arti- diphenol-epichlorohydrin resins listed cles intended for use in producing, in other sections of subchapter B of manufacturing, packing, processing, this chapter.

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§ 177.1460 Melamine-formaldehyde res- basic copolymers produced by the graft ins in molded articles. copolymerization of 73–77 parts by Melamine-formaldehyde resins may weight of acrylonitrile and 23–27 parts be safely used as the food-contact sur- by weight of methyl acrylate in the face of molded articles intended for use presence of 8–10 parts by weight of bu- in producing, manufacturing, packing, tadiene-acrylonitrile copolymers con- processing, preparing, treating, pack- taining approximately 70 percent by aging, transporting, or holding food in weight of polymer units derived from accordance with the following pre- butadiene. scribed conditions: (b) The nitrile rubber modified acry- (a) For the purpose of this section, lonitrile-methyl acrylate basic copoly- melamine-formaldehyde resins are mers meet the following specifications those produced when 1 mole of mel- and extractives limitations: amine is made to react with not more (1) Specifications. (i) Nitrogen content than 3 moles of formaldehyde in water is in the range 16.5–19 percent as deter- solution. mined by Kjeldahl analysis. (b) The resins may be mixed with re- (ii) Intrinsic viscosity in acetonitrile ° fined woodpulp and the mixture may at 25 C is not less than 0.29 deciliter contain other optional adjuvant sub- per gram as determined by ASTM stances which may include the fol- method D1243–79, ‘‘Standard Test Meth- lowing: od for Dilute Solution Viscosity of Vinyl Chloride Polymers,’’ which is in- List of substances Limitations corporated by reference. Copies may be obtained from the American Society Colorants used in accordance with § 178.3297 for Testing Materials, 1916 Race St., of this chapter. Philadelphia, PA 19103, or may be ex- Dioctyl phthalate ...... For use as lubricant. amined at the Office of the Federal Hexamethylenetetramine For use only as polymerization reaction control agent. Register, 800 North Capitol Street, Phthalic acid anhydride .. Do. NW., suite 700, Washington, DC 20408. Zinc stearate ...... For use as lubricant. (iii) Residual acrylonitrile monomer content is not more than 11 parts per (c) The molded melamine-formalde- million as determined by gas chroma- hyde articles in the finished form in tography. which they are to contact food, when (iv) Acetonitrile-soluble fraction extracted with the solvent or solvents after refluxing the base polymer in ace- characterizing the type of food and tonitrile for 1 hour is not greater than under the conditions of time and tem- 95 percent by weight of the basic co- perature as determined from tables 1 polymers. and 2 of § 175.300(d) of this chapter, (2) Extractives limitations. The fol- shall yield net chloroform-soluble ex- lowing extractive limitations are de- tractives not to exceed 0.5 milligram termined by an infrared per square inch of food-contact surface. spectrophotometric method titled, [42 FR 14572, Mar. 15, 1977, as amended at 56 ‘‘Infrared Spectrophotometric Deter- FR 42933, Aug. 30, 1991] mination of Polymer Extracted from Borex 210 Resin Pellets,’’ which is in- § 177.1480 Nitrile rubber modified ac- corporated by reference. Copies are rylonitrile-methyl acrylate copoly- available from the Center for Food mers. Safety and Applied Nutrition (HFS– Nitrile rubber modified acrylonitrile- 200), Food and Drug Administration, methyl acrylate copolymers identified 5100 Paint Branch Pkwy., College Park, in this section may be safely used as MD 20740, or available for inspection at components of articles intended for the Office of the Federal Register, 800 food-contact use under conditions of North Capitol Street, NW., suite 700, use D, E, F, or G described in table 2 of Washington, DC 20408, and are applica- § 176.170(c) of this chapter, subject to ble to the basic copolymers in the form the provisions of this section. of particles of a size that will pass (a) For the purpose of this section, through a U.S. standard sieve No. 6 and nitrile rubber modified acrylonitrile- that will be held on a U.S. standard methyl acrylate copolymers consist of sieve No. 10:

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(i) Extracted copolymer not to ex- (6) Nylon 6 resins are manufactured ceed 2.0 parts per million in aqueous by the polymerization of epsilon- extract obtained when a 100-gram sam- caprolactam. ple of the basic copolymers is extracted (7) Nylon 66T resins are manufac- with 250 milliliters of demineralized tured by the condensation of (deionized) water at reflux temperature hexamethyl-enediamine, adipic acid, for 2 hours. and terephthalic acid such that com- (ii) Extracted copolymer not to ex- position in terms of ingredients is ceed 0.5 part per million in n-heptane 43.1±0.2 weight percent hexamethyl- extract obtained when a 100-gram sam- enediamine, 35.3±1.2 weight percent ple of the basic copolymers is extracted adipic acid, and 21.6±1.2 weight percent with 250 milliliters of reagent grade n- terephthalic acid. heptane at reflux temperature for 2 (8) Nylon 612 resins are manufactured hours. by the condensation of hexamethylenediamine and (c) Acrylonitrile copolymers identi- dodecanedioic acid. fied in this section shall comply with (9) Nylon 12 resins are manufactured the provisions of § 180.22 of this chap- by the condensation of omega- ter. laurolactam. (d) Acrylonitrile copolymers identi- (10)(i) Impact modified Nylon MXD–6 fied in this section are not authorized resins (CAS Reg. No. 59655–05–9) manu- to be used to fabricate beverage con- factured by the condensation of adipic tainers. acid, 1,3-benzenedimethanamine, and [42 FR 14572, Mar. 15, 1977, as amended at 42 T3alpha-(3-aminopropyl)-omega-(3- FR 48544, Sept. 23, 1977; 47 FR 11843, Mar. 19, amino-propoxy)polyoxyethylene 1982; 47 FR 16775, Apr. 20, 1982; 49 FR 10109, under such conditions that the alpha- Mar. 19, 1984; 54 FR 24898, June 12, 1989; 61 FR (3-amino-propyl)-omega-(3- 14481, Apr. 2, 1996] aminopropoxy) polyoxyethylene monomer content does not exceed 7 percent § 177.1500 Nylon resins. by weight of the finished resin. The nylon resins listed in paragraph (ii) Nylon MXD–6 resins (CAS Reg. (a) of this section may be safely used to No. 25718–70–1) manufactured by the produce articles intended for use in condensation of adipic acid and 1,3- processing, handling, and packaging benzenedimethanamine. food, subject to the provisions of this (11) Nylon 12T resins are manufac- section: tured by the condensation of omega- (a) The nylon resins are manufac- laurolactam (CAS Reg. No. 0947–04–6), tured as described in this paragraph so isophthalic acid (CAS Reg. No. 0121–91– as to meet the specifications prescribed 5), and bis(4-amino-3-methylcycl- in paragraph (b) of this section when ohexyl)methane (CAS Reg. No. 6864–37– 5) such that the composition in terms tested by the methods described in ± paragraph (c) of this section. of ingredients is 34.4 1.5 weight percent omega-laurolactam, 26.8±0.4 weight per- (1) Nylon 66 resins are manufactured cent isophthalic acid, and 38.8±0.5 by the condensation of hexamethylene- weight percent bis(4-amino-3- diamine and adipic acid. methylcyclohexyl)-methane. (2) Nylon 610 resins are manufactured (12) Nylon 6I/6T resins (CAS Reg. No. by the condensation of hexamethylene- 25750–23–6) are manufactured by the diamine and sebacic acid. condensation of (3) Nylon 66/610 resins are manufac- hexamethylenediamine, terephthalic tured by the condensation of equal- acid, and isophthalic acid such that 65 weight mixtures of nylon 66 salts and to 80 percent of the polymer units are nylon 610 salts. derived from hexamethylene (4) Nylon 6/66 resins manufactured by isophthalamide. the condensation and polymerization of (13)(i) Nylon 6/12 resins (CAS Reg. No. Nylon 66 salts and epsilon-caprolactam. 25191–04–2) are manufactured by the co- (5) Nylon 11 resins are manufactured polymerization of a 1 to 1 ratio by by the condensation of 11- weight of epsilon-caprolactam and aminoundecanoic acid. omega-laurolactam.

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(ii) Nylon 6/12 resins (CAS Reg. No. (15) Nylon 46 resins (CAS Reg. No. 25191–04–2) are manufactured by the co- 50327–77–0) are manufactured by the polymerization of a ratio of at least 80 condensation of 1,4-butanediamine and weight percent of epsilon-caprolactam adipic acid. and no more than 20 weight percent of (16) Nylon resins PA 6–3–T (CAS Reg- omega-laurolactam. istry No. 26246–77–5) are manufactured (14) Nylon 6/69 resins (CAS Reg. No. by the condensation of 50 mol percent 51995–62–1) are manufactured by the 1,4-benzenedicarboxylic acid, dimethyl condensation of 49.5+0.5 weight percent ester and 50 mol percent of an equimolar mixture of 2,2,4-trimethyl- epsilon-caprolactam, 19.4+0.2 weight 1,6-hexanediamine and 2,4,4-trimethyl- percent hexamethylenediamine and 1,6-hexanediamine. 31.2+0.3 weight percent azelaic acid. (b) Specifications:

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VerDate mar<24>2004 04:23 Apr 20, 2004 Jkt 203066 PO 00000 Frm 00272 Fmt 8010 Sfmt 8010 Y:\SGML\203066T.XXX 203066T Food and Drug Administration, HHS § 177.1500 Benzene tate Ethyl ace- 95 percent ethyl alcohol pressed in percent by weight of resin) Water Maximum extractable fraction in selected solvents (ex- Viscosity No. (mL/g) ...... 1.5 2.0 1.0 ...... 1.0 .25 ...... 30 .35 .25 .3 ...... 1.5 0.2 1.0 2.0 ...... 1.0 2.0 N HC1 h. after 1 h. after 1 h. h. after 1 h. h. Solubility in boiling 4.2 enheit) Melting point (degrees Fahr- .015 375–395 Dissolves in 1 ...... do...... 015 355–375 .35 1.60 .35 .40 ...... do...... 015 335–355 1.0 2.0 1.50 1.50 .015 440–460 ...... do...... do...... 440–460 380–425 .015 2.0 1.5 .015 0.8 1.0 0.5 Insoluble .015 355–375 ...... do...... 392–446 .015 1.5 2.0 1.0 .015 482–518 Insoluble .015 482–518 ...... do...... 015 406–420 .50 1.50 .50 .50 .015 Insoluble .015 405–425 475–495 Dissolves in 1 .015 392–446 Dissolves in 1 ± ± ± ± ± ± ± ± ± ± ± ± 1.13 1.14 1.04 1.15 1.16 1.06 ...... epsi- F), and B through ° caprolactam monomer F. ° epsilon- Nylon resins Specific gravity caprolactam monomer content not to exceed with food. time use in contact with food and which are compliance with § 175.300 of this chapter. H of table 2 § 176.170(c) of this chapter, except as provided in § 177.1390(d) lon- 0.4 percent by weight. For use only as specified in § 177.1395 of this chapter (CAS Reg. No. 24993– 04–2). content not to exceed 0.7 percent by weight. content greater than 60 percent and residual time use or repeated in contact with food. a. In articles intended for repeated use in contact b. In side-seam cements for articles intended 1- having an average thickness not to exceed 0.001 in. having an average thickness not to exceed 0.001 in. for repeated use in contact with food at temperatures not to exceed 212 not to exceed 0.0016 inch intended for use in contact with nonalcoholic food under the conditions of use A (sterilization not to exceed 30 minutes at a temperature not to exceed 250 1. Nylon 66 resins ...... 2. Nylon 610 resins ...... 3.1 Nylon 66/610 resins 1.14 ...... 4.1 1.09 Nylon 6/66 resins, 4.2 1.10 Nylon 6/66 resins with combined caprolactam 5.1 Nylon 11 resins for use in articles intended 1- 5.2 Nylon 11 resins for use only: 6.1 Nylon 6 resins ...... 6.2 Nylon 6 resins for use only in food-contact films 7. Nylon 66T resins for use only in food-contact films 1.15 1.04 8. Nylon 612 resins for use only in articles intended 9. Nylon 12 resins for use only: ...... a. In food-contact films having an average thickness 1.01

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VerDate mar<24>2004 04:23 Apr 20, 2004 Jkt 203066 PO 00000 Frm 00274 Fmt 8010 Sfmt 8010 Y:\SGML\203066T.XXX 203066T Food and Drug Administration, HHS § 177.1500 3.0 ...... 1.0 1.5 0.5 od described in § 177.1500(c)(5)(ii) of this chapter...... 0.2 1.0 0.1 ...... 0.3 0.2 Greater than 160...... than 0.8 1.0 0.5 Greater > 110 ...... 0.007 0.64 0.003 0 Greater than 140 ...... 2.0 ...... 1.5 1.5 after 1 hour. h. h. h. after 1 h. hour. 0.1 N/A Insoluble 0.1 N/A ± 0.15 380–400 Dissolves in 1 Insoluble 0.03 NA 0.02 270–277 ...... >140 using the meth- 0.15 400–420 Dissolves in 1 ± ± ± 0.015 260–285 Dissolves in 1 0.015 551–09592 Dissolves in 1 ± ± ± 1.10 1.12 1.207 1.09 1.13 1.06 1.18 - - epsilon epsilon C. ° -laurolactam not to exceed 0.1 -laurolactam not to exceed 0.1 omega omega of food except alcoholic beverages containing more than 8 percent alcohol. films having an average thickness not to exceed 51 microns (0.002 inch). The finished film is intended to contact all foods except those containing more than 8 percent ethanol under conditions of use B, C, D, E, F, G, and H listed in table 2 of § 176.170(c) of this chapter. percent by weight. For use only as specified in § 177.1395 of this chapter. percent by weight. For use only as specified in § 177.1390 of this chapter. CFR 177.1395 of this chapter. brane filters intended for repeated use. The finished membrane filter is intended to contact beverages containing no more than 13 percent alcohol, under conditions of use E, F, and G listed in table 2 § 176.170(c) of this chapter. ing bottles) in contact with food of type VIA and VIB described in table 1 of § 176.170(c) of this chapter under conditions of use D through H described in table 2 of § 176.170(c) of this chapter with a hot-fill temperature limitation of 40 caprolactam not to exceed 0.5 percent by weight and residual caprolactam not to exceed 0.8 percent by weight and residual 12. Nylon 6I/6T resins for use in contact with all types 13.1 Nylon 6/12 resins for use only in food-contact 13.2 Nylon 6/12 resins with residual 13.3 Nylon 6/12 resins with residual 14. Nylon 6/69 resins for use only as specified in 21 15. Nylon 46 resins for use only in food-contact mem- 16. Nylon resins PA 6–3–T for repeated-use (exclud-

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(c) Nylon modifier—(1) Identity. Co- of Nylon modifiers listed in paragraph polyester-graft-acrylate copolymer is (c)(1) of this section may include: the substance 1,4-benzenedicarboxylic (A) Substances generally recognized acid, polymer with 1,4-butanediol, (E)- as safe for use in food and food pack- 2-butenedioic acid, 1,2-ethanediol, aging; ethyl 2-propenoate, hexanedioic acid (B) Substances subject to prior sanc- and 2-propenoic acid, graft (CAS Reg. tion or approval for use in Nylon resins No. 175419–23–5), and is derived from and used in accordance with such sanc- grafting of 25 weight percent of acrylic tions or approval; and polymer with 75 weight percent of co- (C) Optional substances required in polyester. The copolyester is polym- the production of the additive identi- erized terephthalic acid (55 mol%), fied in this paragraph and other op- adipic acid (40 mol%), and fumaric acid tional substances that may be required (5 mol%) with ethylene glycol (40 to accomplish the intended physical or mol%) and 1,4-butanediol (60 mol%). technical effect. The acrylic polymer is made from (d) Analytical methods—(1) Specific acrylic acid (70 mol%) and ethyl acry- gravity. Specific gravity shall be deter- late (30 mol%). mined by weighing a 1-gram to 5-gram (2) Specifications. The finished copoly- sample first in air and then in freshly ester-graft-acrylate copolymer shall boiled distilled water at 23 °C±2 °C. meet the following specifications: (2) Melting point. The melting point (i) Weight average molecular weight shall be determined as follows: Use a 15,000–35,000, hot-stage apparatus. The use of crossed nicol prisms with a microscope hot (ii) pH 7.2 to 8.2, and stage and reading of the thermometer (iii) Glass transition temperature when the birefringence disappears in- ¥ ¥ ° 15 to 25 C. creases the accuracy. If the crossed (3) Conditions of use. (i) Copolyester- nicol apparatus is not available, use graft acrylate copolymer described in the lowest temperature at which the paragraph (c)(1) of this section is in- sample becomes transparent or the tended to improve the adhesive quali- sharp edges or corners of the sample ties of film. It is limited for use as a become rounded as the melting point. modifier of Nylon 6 and Nylon 6 modi- In case of doubt as to the onset of fied with Nylon MXD–6 at a level not melting, the sample is prodded with a to exceed 0.17 weight percent of the ad- sharp instrument. If it sticks to the ditive in the finished film. heating block, it is considered to have (ii) The finished film is used for pack- melted. If the melting point is low, dry aging, transporting, or holding all the sample in an oven at 85 °C for 24 types of foods under conditions of use B hours in a nitrogen atmosphere then through H, described in table 2 of repeat the test. § 176.170(c) of this chapter, except that (3) Solubility in boiling 4.2N HCl. The in the case of Nylon 6 films modified test shall be run on a sample approxi- with Nylon MXD–6 (complying with mately the size of a 1⁄8-inch cube in at § 177.1500, item 10.2), the use complies least 25 milliliters of 4.2 normal hydro- with the conditions of use specified in chloric acid. table 2. (4) Maximum extractable fraction in se- (iii) Extractives. Food contact films lected solvents. The procedure for deter- described in paragraphs (c)(1) of this mining the maximum extractable frac- section, when extracted with solvent or tion of the nylon resins in selected sol- solvents prescribed for the type of food vents is as follows: and under conditions of time and tem- (i) Film should be cut with ordinary perature specified for the intended use, scissors into pieces of a convenient size shall yield total extractives not to ex- such as 1⁄4-inch squares, for the extrac- ceed 0.5 milligram per inch squared of tion tests described in this section. The food-contact surface when tested by granules of nylon molding powders are the methods described in § 176.170(d) of in the proper form for the extraction this chapter. tests. Samples of fabricated articles (iv) Optional adjuvant substances. The such as pipe, fittings, and other similar substances employed in the production articles must be cut to approximately

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the size of the molding powder. This Copies are available from the Center can be done conveniently by using a for Food Safety and Applied Nutrition small-scale commercial plastics (HFS–200), Food and Drug Administra- granulator and cutting the sample tion, 5100 Paint Branch Pkwy., College through a screen having 1⁄4-inch mesh. Park, MD 20740, or available for inspec- Fine particles should be separated from tion at the Office of the Federal Reg- the cut resin by screening through a 20- ister, 800 North Capitol Street, NW., mesh screen. The material retained on suite 700, Washington, DC 20408. the screen is suitable for the extraction (ii) The viscosity number (VN) for tests. Nylon 6/69 and Nylon PA–6–3–T resins (ii) The organic solvents must be of in a 99 percent cresol solution (5 milli- American Chemical Society analytical grams resin per milliliter) shall be de- reagent grade; distilled water is used. termined at 25 °C (77 °F) by method ISO Approximately 30 grams of the pre- 307–1984(E), ‘‘Plastics-Polyamides-De- pared sample is weighed to the nearest termination of Viscosity Number,’’ milligram. The weighed resin is trans- which is incorporated by reference. The ferred to a 500-milliliter round-bottom availability of this incorporation by flask equipped with a reflux condenser. reference is given in paragraph (d)(5)(i) Approximately 300-milliliters of sol- of this section. vent is added to the flask and the contents refluxed gently for 8 hours with a [42 FR 14572, Mar. 15, 1977] heating mantle. The solvent is then fil- EDITORIAL NOTE: For FEDERAL REGISTER ci- tered off immediately while still hot, tations affecting § 177.1500, see the List of using a Buchner funnel approximately CFR Sections Affected, which appears in the 5 inches in diameter, a suction flask, Finding Aids section of the printed volume and on GPO Access. and a hardened filter paper (Whatman No. 50 or equivalent). The paper is wet § 177.1520 Olefin polymers. with the solvent and a slight suction applied just before starting the filtra- The olefin polymers listed in para- tion. The resin is washed twice with graph (a) of this section may be safely approximately 100-milliliter portions of used as articles or components of arti- solvent and the combined filtrate and cles intended for use in contact with washings are reduced to approximately food, subject to the provisions of this 25 milliliters by evaporation at reduced section. pressure (50 millimeters to 100 millime- (a) For the purpose of this section, ters of mercury, absolute), heating as olefin polymers are basic polymers necessary. The contents of the flask manufactured as described in this para- are transferred to an evaporation dish graph, so as to meet the specifications (which has been held in a vacuum des- prescribed in paragraph (c) of this sec- iccator over anhydrous calcium sulfate tion, when tested by the methods de- until constant weight has been at- scribed in paragraph (d) of this section. tained) and carefully evaporated to (1)(i) Polypropylene consists of basic dryness. The weight of the solid residue polymers manufactured by the cata- is determined by difference after hold- lytic polymerization of propylene. ing in a vacuum desiccator over anhy- (ii) Propylene homopolymer consists drous calcium sulfate until constant of basic polymers manufactured by the weight has been attained. The percent catalytic polymerization of propylene of solids extracted is calculated by di- with a metallocene catalyst. viding the weight of the solid residue (2)(i) Polyethylene consists of basic by the weight of the sample and multi- polymers manufactured by the cata- plying by 100. lytic polymerization of ethylene. (5) Viscosity number (VN). (i) The vis- (ii) Fumaric acid-grafted poly- cosity number (VN) for Nylon 6/12 resin ethylene (CAS Reg. No. 26877–81–6) con- in a 96 percent sulfuric acid solution (5 sists of basic polymers manufactured milligrams resin per milliliter) shall be by the catalytic polymerization of determined at 25 °C (77 °F) by method ethylene followed by reaction with fu- ISO 307–1984(E), ‘‘Plastics-Polyamides- maric acid in the absence of free rad- Determination of Viscosity Number,’’ ical initiators. Such polymers shall which is incorporated by reference. contain grafted fumaric acid at levels

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not to exceed 2 percent by weight of propylene or butene-1, shall contain the finished polymer. not less than 85 weight percent poly- (3) Olefin basic copolymers consist of mer units derived from ethylene. basic copolymers manufactured by the (e) Olefin basic copolymers manufac- catalytic copolymerization of: tured by the catalytic polymerization (i) Two or more of the 1-alkenes hav- of ethylene and octene-1, or ethylene, ing 2 to 8 carbon atoms. Such olefin octene-1, and either hexene-1, butene-1, basic copolymers contain not less than propylene, or 4-methylpentene-1 shall 96 weight-percent of polymer units de- contain not less than 80 weight percent rived from ethylene and/or propylene, of polymer units derived from ethyl- except that: ene. (a)(1) Olefin basic copolymers manu- (ii) 4-Methylpentene-1 and 1-alkenes factured by the catalytic copolym- having from 6 to 18 carbon atoms. Such erization of ethylene and hexene-1 or olefin basic copolymers shall contain ethylene and octene-1 shall contain not not less than 95 molar percent of poly- less than 90 weight-percent of polymer mer units derived from 4- units derived from ethylene; methylpentene-1, except that copoly- (2) Olefin basic copolymers manufac- mers manufactured with 1-alkenes hav- tured by the catalytic copolymeriza- ing from 12 to 18 carbon atoms shall tion of ethylene and hexene-1 shall con- contain not less than 97 molar percent tain not less than 80 but not more than of polymer units derived from 4- 90 weight percent of polymer units de- methylpentene-1; or rived from ethylene. (iii) Ethylene and propylene that (3) Olefin basic copolymers manufac- may contain as modifiers not more tured by the catalytic copolymeriza- than 5 weight-percent of total polymer tion of ethylene and pentene-1 shall units derived by copolymerization with contain not less than 90 weight-percent one or more of the following mono- of polymer units derived from ethyl- mers: ene. (4) Olefin basic copolymers manufac- 5-Ethylidine-2-norbornene. tured by the catalytic polymerization 5-Methylene-2-norbornene. of ethylene and octene-1 shall contain not less than 50 weight-percent of poly- (iv) Ethylene and propylene that may mer units derived from ethylene. contain as a modifier not more than 4.5 (b) Olefin basic copolymers manufac- weight percent of total polymer units tured by the catalytic copolymeriza- derived by copolymerization with 1,4- tion of ethylene and 4-methylpentene-1 hexadiene. shall contain not less than 89 weight- (v) Ethylene and butene-1 copolymers percent of polymer units derived from (CAS Reg. No. 25087–34–7) that shall ethylene; contain not less than 80 weight percent (c)(1) Olefin basic copolymers manu- of polymer units derived from ethyl- factured by the catalytic copolym- ene. erization of two or more of the mono- (vi) Olefin basic copolymers (CAS mers ethylene, propylene, butene-1, 2- Reg. No. 61615–63–2) manufactured by methylpropene-1, and 2,4,4- the catalytic copolymerization of trimethylpentene-1 shall contain not ethylene and propylene with 1,4- less than 85 weight-percent of polymer hexadiene, followed by reaction with units derived from ethylene and/or pro- fumaric acid in the absence of free rad- pylene; ical initiators. Such polymers shall (2) Olefin basic copolymers manufac- contain not more than 4.5 percent of tured by the catalytic copolymeriza- polymer units deriving from 1,4- tion of propylene and butene-1 shall hexadiene by weight of total polymer contain greater than 15 but not greater prior to reaction with fumaric acid and than 35 weight percent of polymer not more than 2.2 percent of grafted fu- units derived from butene-1 with the maric acid by weight of the finished remainder being propylene. polymer. (d) Olefin basic terpolymers manufac- (vii) Ethylene and 2-norbornene (CAS tured by the catalytic copolymeriza- Reg. No. 26007–43–2) copolymers that tion of ethylene, hexene-1, and either shall contain not less than 30 and not

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more than 70 mole percent of polymer weight of copolymer units derived from units derived from 2-norbornene. maleic anhydride. (4) Poly(methylpentene) consists of (b) The basic olefin polymers identi- basic polymers manufactured by the fied in paragraph (a) of this section catalytic polymerization of 4- may contain optional adjuvant sub- methylpentene-1. stances required in the production of (5) Polyethylene graft copolymers such basic olefin polymers. The op- consist of polyethylene complying with tional adjuvant substances required in item 2.2 of paragraph (c) of this section the production of the basic olefin poly- which subsequently has 3a,4,7,7a- tetrahydromethyl-4,7- mers or finished food-contact articles methanoisobenzofuran-1,3-dione graft- may include substances permitted for ed onto it at a level not to exceed 1.7 such use by applicable regulations in percent by weight of the finished co- parts 170 through 189 of this chapter, polymer. substances generally recognized as safe (6) Ethylene-maleic anhydride co- in food and food packaging, substances polymers (CAS Reg. No. 9006–26–2) con- used in accordance with a prior sanc- taining no more than 2 percent by tion or approval, and the following:

Substance Limitations

Aromatic petroleum hydrocarbon resin, hydrogenated (CAS For use only as an adjuvant at levels not to exceed 25 percent Reg. No. 88526–47–0), produced by the catalytic polym- by weight in blends with polypropylene complying with para- erization of aromatic-substituted olefins from distillates of graph (c), item 1.1 of this section. The finished polymer may cracked petroleum stocks with a boiling point no greater than be used in contact with food Types I, II, IV–B, VI–A through 220 °C (428 °F), and the subsequent catalytic hydrogenation VI–C, VII–B, and VIII identified in table 1 of § 176.170(c) of of the resulting aromatic petroleum hydrocarbon resin, hav- this chapter and under conditions of use B through H de- ing a minimum softening point of 110 °C (230 °F), as deter- scribed in table 2 of § 176.170(c) of this chapter; and with mined by ASTM Method E 28–67 (Reapproved 1982), food Types III, IV–A, V, VII–A, and IX identified in table 1 of ‘‘Standard Test Method for Softening Point by Ring-and-Ball § 176.170(c) of this chapter and under conditions of use D Apparatus,’’ and a minimum aniline point of 107 °C (225 °F), through G described in table 2 of § 176.170(c) of this chap- as determined by ASTM Method D 611–82, ‘‘Standard Test ter. Methods for Aniline Point and Mixed Aniline Point of Petro- leum Products and Hydrocarbon Solvents,’’ both of which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the American Society for Testing and Materials, 1916 Race St., Philadelphia, PA 19103, or from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra- tion, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. Colorants used in accordance with § 178.3297 of this chapter. 2,5-Dimethyl-2,5-di(tert-butylperoxy)hexane (CAS Reg. No. 78– For use as an initiator in the production of propylene 63–7). homopolymer complying with § 177.1520(c), item 1.1 and olefin copolymers complying with § 177.1520(c), items 3.1 and 3.2 and containing not less than 75 weight percent of polymer units derived from propylene, provided that the maximum concentration of tert-butyl alcohol in the polymer does not exceed 100 parts per million, as determined by a method titled ‘‘Determination of tert-Butyl Alcohol in Polypropylene,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

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Substance Limitations

Methyl methacrylate/butyl acrylate-grafted polypropylene co- For use only at levels not to exceed 6 percent by weight of polymer containing methyl methacrylate/butyl acrylate-grafted olefin polymers complying with paragraph (c) of this section, polypropylene (CAS Reg. No. 121510–09–6), methyl meth- items 1.1, 3.1a, 3.2a, and 3.2b, where the copolymers com- acrylate/butyl acrylate copolymer (CAS Reg. No. 25852–37– plying with items 3.1a, 3.2a, and 3.2b contain not less than 3), methyl methacrylate homopolymer (CAS Reg. No. 9011– 85 weight-percent of polymer units derived from propylene. 14–7), and polypropylene (CAS Reg. No. 9003–07–0), resulting from the reaction of a mixture of methyl methacrylate and butyl acrylate with polypropylene. The finished product contains no more than 55 percent by weight of polymer units derived from methyl methacrylate and butyl acrylate as determined by a method entitled, ‘‘Determination of the Total Acrylic in PP–MMA/BA Polymers,’’ which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Premarket Approval, Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition’s Li- brary, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. Petroleum hydrocarbon resins (cyclopentadiene-type), hydro- For use only as an adjuvant at levels not to exceed 30 percent genated (CAS Reg. No. 68132–00–3) produced by the ther- by weight in blends with: (1) Polypropylene complying with mal polymerization of dicyclopentadiene and cyclodiene paragraph (c), item 1.1 of this section, or (2) a copolymer of codimers (consisting of a mixture of cyclopentadiene, methyl propylene and ethylene containing not less than 94 weight cyclopentadiene, and C4-C5 acyclic dienes), followed by hy- percent propylene and complying with paragraph (c), item drogenation and having a ring-and-ball softening point of 119 3.2 of this section. The average thickness of the food-con- °C minimum as determined by ASTM Method E 28–67 (Re- tact film is not to exceed 0.1 millimeter (0.004 inch). The fin- approved 1982), ‘‘Standard Test Method for Softening Point ished polymer may be used in contact with (1) Food types I, by Ring-and-Ball Apparatus,’’ and a minimum viscosity of II, IV–B, VI–A, VI–B, VII–B, and VIII identified in table 1 of 3,000 centipoise, measured at 160 °C, as determined by § 176.170(c) of this chapter and under conditions of use C ASTM Method D 3236–88, ‘‘Standard Test Method for Ap- through G described in table 2 of § 176.170(c) of this chap- parent Viscosity of Hot Melt Adhesives and Coating Mate- ter; and (2) food types III, IV–A, V, VI–C, VII–A, and IX iden- rials,’’ both of which are incorporated by reference in accord- tified in table 1 of § 176.170(c) of this chapter and under ance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are conditions of use D through G described in table 2 of available from the American Society for Testing and Mate- § 176.170(c) of this chapter. rials, 1916 Race St., Philadelphia, PA 19103, or from the Center For Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. Polymethylsilsesquioxane (CAS Reg. No. 68554–70–1) ...... For use only as a surface lubricant or anti-blocking agent in films. Poly(vinylidene fluoride) homopolymer (CAS Reg. No. 24937– For use only as a processing aid in the production of olefin 79–9), having a melt viscosity of 6 to 37 kilopoise at a shear polymers complying with paragraph (c) of this section at lev- rate of 100¥1 seconds at 232 °C as determined by ASTM els not to exceed 1.0 percent by weight of the polymer. The Method D 3835–79 (Reapproved 1983), ‘‘Standard Test finished polymers may be used only under the conditions de- Method for Rheological Properties of Thermoplastics with a scribed in § 176.170(c) of this chapter, table 2, under condi- Capillary Rheometer’’ using a capillary of 15:1 L/D, which is tions of use B though H. incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC. Polyoxyethylene-grafted polydimethylsiloxane (CAS Reg. No. For use as an extrusion aid in the production of extruded olefin 68937–54–2). polymers that comply with § 177.1520(c) at levels not to exceed 0.3 percent by weight of the polymer. The finished polymer is used in contact with foods under conditions of use B through H described in table 2 of § 176.170 of this chapter.

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Substance Limitations

Triisopropanolamine (CAS Reg. No. 122–20–3) ...... For use as a Zeigler-Natta-type catalyst deactivator and antioxidant in the production of olefin polymers complying with § 177.1520(c), items 2.1, 2.2, and 2.3, and having a minimum density of 0.94 grams per cubic centimeter, and copolymers complying with § 177.1520(c), items 3.1 and 3.2, for use in contact with all foods under the following conditions of use: (a) films with a maximum thickness of 0.102 millimeter (0.004 inch) may be used under conditions A through H defined in table 2 of § 176.170(c) of this chapter; and (b) articles with thickness greater than 0.102 millimeter (0.004 inch) may be used under conditions C through G defined in table 2 of § 176.170(c) of this chapter. Trimethylpyridine and dimethylpyridine mixture having percent For use only as an adjuvant substance in the production of by weight composition as follows: 2,4,6-trimethylpyridine propylene homopolymers complying with items 1.1, 1.2, and (CAS Reg. No. 108–75–8), not less than 60 percent; 2,3,6- 1.3, and propylene copolymers complying with items 3.1, trimethylpyridine (CAS Reg. No. 1462–84–6), not more than and 3.2 of paragraph (c) of this section provided that the ad- 27 percent; 3,5-dimethylpyridine (CAS Reg. No. 591–22–0), juvant is used at a level not to exceed 20 parts per million not more than 12 percent; and other dimethylpyridines, not by weight of the olefin polymers. more than 6 percent. Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as an extrusion aid in the production of extruded No. 9011–17–0) having a fluorine content of 65 to 71 per- olefin polymers at levels not to exceed 0.2 percent by weight cent and a Mooney viscosity of at least 28, as determined by of the polymer. The finished polymers may be used only a method entitled ‘‘Mooney Viscosity,’’ which is incorporated under the conditions described in § 176.170(c) of this chap- by reference in accordance with 5 U.S.C. 552(a). Copies are ter, table 2, under conditions of use B through H. available from the Center for Food Safety and Applied Nutri- tion (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC. Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as a processing aid in the production of olefin No. 9011–17–0), having a vinylidene fluoride content of not polymers complying with paragraph (c) of this section at lev- less than 87 percent but less than 100 percent by weight els not to exceed 1.0 percent by weight of the polymer. The and a melt viscosity of 12 to 27 kilopoise at a shear rate of finished polymers may be used only under the conditions de- 100¥1 seconds at 232 °C as determined by ASTM Method D scribed in § 176.170(c) of this chapter, table 2, under condi- 3835–79 (Reapproved 1983), ‘‘Standard Test Method for tions of use B though H. Rheological Properties of Thermoplastics with a Capillary Rheometer’’ using a capillary of 15:1 L/D, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Wash- ington, DC 20408.

Maximum extract- Maximum soluble Melting Point able fraction (ex- fraction (ex- (MP) or softening pressed as per- pressed as per- Olefin polymers Density point (SP) (De- cent by weight of cent by weight of grees Centi- the polymer) in N- polymer) in xy- grade)– hexane at speci- lene at specified fied temperatures temperatures

1.1a. Polypropylene described in paragraph 0.880–0.913 MP: 160°–180 °C 6.4 pct at reflux 9.8 pct at 25 °C (a)(1)(i) of this section temperature 1.1b. Propylene homopolymer described in 0.880–0.913– MP: 150°–180 °C 6.4 pct at reflux 9.8 pct at 25 °C paragraph (a)(1)(ii) of this section temperature 1.2. Polypropylene, noncrystalline; for use 0.80–0.88 only to plasticize polyethylene described under items 2.1 and 2.2 of this table, provided that such plasticized polymers meet the maximum extractable fraction and maximum soluble fraction specifications prescribed for such basic polyethylene

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1.3. Polypropylene, noncrystalline, for use 0.80–0.88 SP:115°–138 °C. only: To plasticize polypropylene described by item 1.1 of this table, provided that such plasticized polymers meet the maximum extractable fraction and maximum soluble fraction specifications prescribed for such basic polypropylene, and further provided that such plasticized polypropylene contacts food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, II, IV–B, VI–B, VII–B, and VIII; and for use at levels not to exceed 50 pct by weight of any mixture employed as a food- contact coating provided such coatings contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, II, IV–B, VI–B, VII–B, and VIII 2.1. Polyethylene for use in articles that con- 0.85–1.00 ...... 5.5 pct at 50 °C 11.3 pct at 25 °C tact food except for articles used for packing or holding food during cooking 2.2. Polyethylene for use in articles used for 0.85–1.00 ...... 2.6 pct at 50 °C Do. packing or holding food during cooking 2.3. Polyethylene for use only as component 0.85–1.00 ...... 53 pct at 50 °C 75 pct at 25 °C of food-contact coatings at levels up to and including 50 percent by weight of any mixture employed as a food-contact coating 2.4. Olefin polymers described in paragraph (a)(2)(ii) of this section, having a melt flow index not to exceed 17 grams/per 10 minutes as determined by the method described in paragraph (d)(7) of this section, for use in blends with other polymers at levels not to exceed 20 percent by weight of total polymer, subject to the limitation that when contacting food of types III, IV–A, V, VI–C, VII–A, and IX identified in § 176.170(c) of this chapter, Table 1, the polymers shall be used only under conditions of use C, D, E, F, and G, described in § 176.170(c) of this chapter, Table 2. 3.1a. Olefin copolymers described in para- 0.85–1.00 ...... 5.5 pct at 50 °C 30 pct at 25 °C graph (a)(3)(i) of this section for use in articles that contact food except for articles used for packing or holding food during cooking; except olefin copolymers described in paragraph (a)(3)(i)(a)(3) of this section and listed in item 3.1c of this table and olefin copolymers described in paragraph (a)(3)(i)(e) of this section and listed in item 3.1b of this table 3.1b. Olefin copolymers described in para- 0.9–1.00 ...... Do Do. graph (a)(3)(i)(e) of this section for use in contact with food only under conditions of use D, E, F, G, and H described in § 176.170(c) of this chapter, table 2 3.1c. Olefin copolymers described in para- Not less than 0.92 graph (a)(3)(i)(a)(3) of this section for use in contact with food only under conditions of use B, C, D, E, F, G, and H described in § 176.170(c) of this chapter, table 2; except that such copolymers when used in contact with food of the types identified in § 176.170(c), table 1, under types III, IVA, V, VIIA, and IX, shall be used only under conditions of use D, E, F, and G described in § 176.170(c) of this chapter, table 2

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3.2a. Olefin copolymers described in para- 0.85–1.00 ...... 2.6 pct at 50 °C Do. graph (a)(3)(i) of this section for use in articles used for packing or holding food during cooking; except olefin copolymers described in paragraph (a)(3)(i)(c)(2) of this section and listed in item 3.2b of this table; except that olefin copolymers containing 89 to 95 percent ethylene with the remainder being 4-methyl-pentene-1 contacting food Types III, IVA, V, VIIA, and IX identified in § 176.170(c) of this chapter, table 1, shall not exceed 0.051 millimeter (mm) (0.002 inch (in)) in thickness when used under conditions of use A and shall not exceed 0.102 mm (0.004 in) in thickness when used under conditions of use B, C, D, E, and H described in § 176.170(c) of this chapter, table 2. Additionally, olefin copolymers described in (a)(3)(i)(a)(2) of this section may be used only under conditions of use B, C, D, E, F, G, and H described in § 176.170(c) of this chapter, table 2, in contact with all food types identified in § 176.170(c) of this chapter, table 1 3.2b. Olefin copolymers described in para- Do. graph (a)(3)(i)(c)(2) of this section have a melt flow index no greater than 10 grams per 10 minutes as determined by the method described in paragraph (d)(7) of this section, and the thickness of the finished polymer contacting food shall not exceed 0.025 mm (0.001 in). Additionally, optional adjuvants permitted for use in olefin copolymers complying with item 3.2a of this table may be used in the production of this copolymer 3.2c. Olefin copolymers described in para- 0.85–0.92 ...... graph (a)(3)(i)(a)(4) of this section have a melt flow index no greater than 50 grams per 10 minutes as determined by the method described in paragraph (d)(7) of this section. Articles manufactured using these polymers may be used with all types of food under conditions of use C through H as described in table 2 of § 176.170(c) of this chapter 3.3a. Olefin copolymers described in para- ...... graph (a)(3)(ii) of this section and manufactured with 1-alkenes having from 6 to 10 carbon atoms 3.3b. Olefin copolymers described in paragraph (a)(3)(ii) of this section, provided that such olefin polymers have a melt temperature of 220 °C to 250 °C (428 °F to 482 °F) as determined by the method described in paragraph (d)(8) of this section and minimum intrinsic viscosity of 1.0 as determined in paragraph (d)(9) of this section.

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3.4. Olefin copolymers, primarily non-crys- 0.85–0.90 talline, described in par. (a)(3) (iii) of this section provided that such olefin polymers have a minimum viscosity average molecular weight of 120,000 as determined by the method described in par. (d)(5) of this section and a minimum Mooney viscosity of 35 as determined by the method described in par. (d)(6) of this section, and further provided that such olefin copolymers contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, II, III, IV-B, VI, VII, VIII, and IX 3.5. Olefin copolymers, primarily non-crys- 0.85–0.90 talline, described in paragraph (a)(3)(iv) of this section, provided that such olefin polymers have a minimum viscosity average molecular weight of 95,600 as determined by the method described in paragraph (d)(5) of this section, and further provided that such olefin polymers are used only in blends with olefin polymers described under items 1.1, 2.1, and 2.2 of this table at a maximum level of 25 pct by weight, and provided that such olefin copolymers contact food only of the types identified in § 176.170 (c) of this chapter, table 1, under Types I, II, IV-B, VI, VII-B, and VIII at temperatures not exceeding 190 °F 3.6. Olefin copolymers described in para- Not less than 0.88 graph (a)(3)(v) of this section for use in blends with olefin polymer resins have a melt flow index no greater than 5 grams/10 minutes as determined by the method described in paragraph (d)(7) of this section and the thickness of the finished blends shall not exceed 0.1 millimeter (0.004 inch). The ethylene/butene-1 copolymer may be used subject to the following conditions: (1) For use at a level not to exceed 20 weight percent in polypropylene as described under item 1.1 of this table. (2) For use at a level not to exceed 40 weight percent in polyethylene as described under items 2.1 and 2.2 of this table. (3) For use at a level not to exceed 40 weight percent in olefin copolymers as described under items 3.1 and 3.2 of this table

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3.7. Ethylene/propylene copolymers, meeting Not less than 0.86 the identity described in paragraph (a)(3)(i) of this section, containing not less than 80 mole-percent of polymer units derived from ethylene and having a minimum viscosity average molecular weight of 95,000 as determined by the method described in paragraph (d)(5) of this section, and a minimum Mooney viscosity of 13 as determined by the method described in paragraph (d)(6) of this section. Ethylene/propylene copolymers described in this item 3.7 are to be used only in blends with other olefin polymers complying with this section, at levels not to exceed 30 percent by weight of the total polymer blend, and in contact with food only of types identified in § 176.170(c) of this chapter, Table 1, under Types I, II, III, IV–B, VI, VII, VIII, and IX. Additionally, optional adjuvants permitted for use in olefin copolymers complying with item 3.4 of this table may be used in the production of this copolymer 3.8. Olefin polymers described in paragraph (a)(3)(vi) of this section, having a melt flow index not to exceed 9.2 grams per 10 minutes as determined by the method described in paragraph (d)(7) of this section, for use in blends with other polymers at levels not to exceed 8 percent by weight of total polymer, subject to the limitation that when contacting food of types III, IV–A, V, VI–C, VII–A, and IX, identified in § 176.170(c) of this chapter, Table 1, the polymers shall be used only under conditions of use C, D, E, F, and G, described in § 176.170(c) of this chapter, Table 2. 3.9. Olefin copolymers described in paragraph Not less than 1.0 ...... (a)(3)(vii) of this section may only be used in contact with dry foods, Type VIII, as identified in § 176.170(c) of this chapter, Table 1 4. Poly(methylpentene) 0.82–0.85 MP: 235°–250 °C 6.6 pct at reflux 7.5 pct at 25 °C temperature 5. Polyethylene copolymer described in para- Not less than 0.94 ...... 0.45 pct at 15 °C 1.8 pct at 25 °C graph (a)(5) of this section and having a melt index not to exceed 2, for use, either alone or in blends with other olefin polymers, subject to the limitation that when contacting foods of types III, IV-A, V, VI-C, VII-A, VIII, and IX identified in § 176.170(c) of this chapter, table 1, the thickness of the film (in mils) containing the polyethylene graft copolymer times the concentration of the polyethylene graft copolymer shall not exceed a value of 2 6. Ethylene-maleic anhydride copolymers de- 0.92 or greater ...... 1.36 pct at 50 °C 2.28 pct at 25 °C scribed in paragraph (a)(6) of this section for use as the adhesive component in multilaminate structures, or as the sealant layer in flexible packaging, in contact with food at temperatures not exceeding 49 °C (120 °F)

(d) The analytical methods for deter- this section are as follows, and are ap- mining whether olefin polymers con- plicable to the basic polymer in film form to the specifications prescribed in form not exceeding 4 mils in thickness.

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The film to be tested shall be cut into 2 hours and filtered at the boiling approximately 1-inch squares by any point. The filtrate is evaporated and convenient method that avoids con- the total residue weighed as a measure tamination by dust, dirt, or grease of the solvent extractable fraction. (NOTE: Do not touch samples with bare (a) Apparatus. (1) Erlenmeyer flasks, fingers—use forceps to hold or transfer 250-milliliter, with ground joint. samples). (2) Condensers, Allihn, 400-millimeter (1) Density. Density shall be deter- jacket, with ground joint. mined by ASTM method D1505–68 (Re- (3) Funnels, ribbed 75-millimeter di- approved 1979), ‘‘Standard Test Method ameter, stem cut to 40 millimeters. for Density of Plastics by the Density- (4) Funnels, Buchner type, with Gradient Technique,’’ which is incor- coarse-porosity fritted disc, 60-milli- porated by reference. Copies may be meter diameter. obtained from the American Society (5) Bell jar for vacuum filtration into for Testing Materials, 1916 Race St., beaker. Philadelphia, PA 19103, or may be ex- (b) Reagent. n-Hexane, commercial amined at the Office of the Federal grade, specific gravity 0.663–0.667 (20 °C/ Register, 800 North Capitol Street, 20 °C), boiling range 66 °C-69 °C, or NW., suite 700, Washington, DC 20408. equivalent. (2) Melting point or softening point—(i) (c) Procedure. Weigh 1 gram of sample Melting point. The melting point shall accurately and place in a 250-milliliter be determined by ASTM method D2117– Erlenmeyer flask containing two or 82, ‘‘Standard Test Method for Melting three boiling stones. Add 100 milliliters Point of Semicrystalline Polymers by of solvent, attach the flask to the con- the Hot Stage Microscopy Method,’’ denser (use no grease), and reflux the which is incorporated by reference. The mixture for 2 hours. Remove the flask availability of this incorporation by from the heat, disconnect the con- reference is given in paragraph (d)(1) of denser, and filter rapidly, while still this section. hot, through a small wad of glass wool (ii) Softening point. The softening packed in a short-stem funnel into a point shall be determined by ASTM tared 150-millimeter beaker. Rinse the method E28–67 (Reapproved 1982), flask and filter with two 10-milliliter ‘‘Standard Test Method for Softening portions of the hot solvent, and add the Point by Ring-and-Ball Apparatus,’’ rinsings to the filtrate. Evaporate the which is incorporated by reference. The filtrate on a stream bath with the aid availability of this incorporation by of a stream of nitrogen. Dry the res- reference is given in paragraph (d)(1) of idue in a vacuum oven at 110 °C for 2 this section. hours, cool in a desiccator, and weigh (3) Maximum extractable fraction in n- to the nearest 0.0001 gram. Determine hexane—(i) Olefin copolymers described the blank on 120 milliliters of solvent in paragraph (a)(3)(ii) of this section, evaporated in a tared 150-milliliter polypropylene, and poly(methylpentene). beaker. Correct the sample residue for A sample is refluxed in the solvent for this blank if significant. Calculation:

Grams of residue = Percent extractable with n-hexane. Grams of sample ×100

(ii) Olefin copolymers described in para- the extraction period to give a measure graph (a)(3)(i) of this section and poly- of the solvent extractable fraction. The ethylene. A preweighed sample is ex- maximum n-hexane-extractable frac- tracted at 50 °C for 2 hours and filtered. tion may be determined by the meth- The filtrate is evaporated and the total ods set forth in paragraphs (d)(3)(ii)(a) residue weighed as a measure of the through (d)(3)(ii)(i) of this section. solvent extractable fraction. Alter- (a) Extraction apparatus. Two-liter, natively, the sample is reweighed after straight-walled, Pyrex (or equivalent)

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resin kettles, fitted with three-hole the filtrate in a tared, glass-stoppered ground-glass covers are most conven- Erlenmeyer flask of 1-liter capacity. ient for this purpose. The cover is Determine the weight of the filtrate re- fitted with a thermometer, a gas-tight covered to the nearest gram. Recovery stirrer driven by an air motor or explo- should be at least 90 percent of the sion-proof electric motor, and a reflux original solvent. Losses due to evapo- condenser. The kettle is fitted with an ration during heating and filtering electric heating mantle of appropriate have been found not to exceed 10 per- size and shape, which is controlled by a cent. Transfer about half of the solvent variable-voltage transformer. filtrate to a 1-liter beaker placed on an (b) Evaporating apparatus. Rapid opening in the steam bath and imme- evaporation of large volumes of solvent diately cover with the special ‘‘gas’’ requires special precautions to prevent cover, the inlet tube of which has been contamination by dust. This is facili- attached with flexible tetrafluoro- tated by a special ‘‘gas’’ cover con- ethylene tubing to a source of high-pu- sisting of an inverted flat Pyrex crys- rity nitrogen in series with a stainless tallizing dish of an appropriate size (190 steel heating coil immersed directly in millimeters × 100 millimeters) to fit a the body of the steam bath. Maintain a 1-liter beaker. Through the center of positive flow of warm nitrogen gas the dish are sealed an inlet tube for throughout the evaporation of the sol- preheated, oxygen-free nitrogen, and vent, adding the remainder of the fil- an outlet tube located 1 inch off center. trate from the Erlenmeyer flask as the Nitrogen is fed from the supply source evaporation proceeds. When the volume through a coil of 1⁄4-inch stainless steel of the solvent has been reduced to tubing immersed in the same steam about 50 milliliters, transfer the con- bath used to supply heat for solvent centrated liquid to a previously tared evaporation. All connections are made weighing dish of suitable size. Wash the with flexible tetrafluoroethylene tub- beaker twice with 20–30 milliliter por- ing. tions of warm solvent, adding the (c) Reagents—(1) n-Hexane. Spectro- washings to the weighing dish while grade n-hexane. continuing to evaporate the remainder (2) Nitrogen. High-purity dry nitrogen of the solvent under the gas cover with containing less than 10 parts per mil- its flow of warm nitrogen directed to- lion of oxygen. ward the center of the dish. In the (d) Procedure. Transfer 2.5 grams (ac- event that an insoluble residue that curately weighed to nearest 0.001 gram) cannot be removed with warm solvent of the polymer to the resin kettle. Add remains in the beaker, it may be nec- 1 liter of solvent and clamp top in posi- essary to heat with a small amount of tion. Start water flowing through jack- a higher boiling solvent such as ben- et of the reflux condenser and apply air zene or toluene, transferring these pressure to the stirring motor to washings to the weighing dish before produce vigorous agitation. Turn on final evaporation to dryness. Transfer heating jacket with transformer set at the weighing dish with its residue to a a predetermined voltage to bring the vacuum desiccator, and allow it to re- temperature of the contents to 50 °C main overnight (at least 12 hours), within 20–25 minutes. As the thermom- after which the net weight of the dry eter reading approaches 45 °C–47 °C, re- residue is determined to the nearest duce the voltage to the predetermined 0.0001 gram. Correct the result for any setting that will just maintain the solvent blank equivalent to the non- temperature at 50 °C. Do not overshoot volatile matter determined to be con- the prescribed temperature. Should tained in the amount of solvents used this occur discard the test and start in the test. afresh. Exactly 2 hours after the sol- (e) Extraction apparatus for alternate vent temperature has reached 50 °C, method. Two-liter extraction vessel, disconnect the heater, remove the resin such as a resin kettle or round bottom kettle from the heating jacket, and de- flask, fitted with an Allihn condenser cant the solvent, while still warm, (size C), a 45/50 male joint with a Teflon through a coarse filter paper placed on sleeve, and a Teflon coated stir bar. top of a fritted-glass funnel, collecting Water bath maintained at 49.5 °C ±0.5

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°C containing a submersible magnetic inch squares using clean sharp scissors. stirrer motor with power supply. Other Proceed with Option 1 or 2. suitable means of maintaining tem- Option 1. Using tweezers and noting perature control, such as electric heat- the number of film pieces, transfer 2.5 ing mantles, may be used provided that grams (accurately weighed to 0.1 milli- the temperature range can be strictly gram) of polymer to the extraction ves- maintained. sel. Extract the film sample for 2 (f) Sample basket (Optional). A per- hours. Allow the vessel to cool and fil- forated stainless steel cylindrical bas- ter the contents through a fritted por- ket that is approximately 1.5 inches in celain funnel. Wash the film pieces diameter, 1.6 inches high, and has per- with fresh n-hexane, aspirate to dry- forations of 0.125 inches in diameter for ness, and transfer, using tweezers, to a 33 holes/in2, or 40 percent open area. beaker. Recount the film pieces to The basket should pass freely through verify that none were lost during the the 45/50 female joint of the extraction transfer. Place the beaker in the vacu- flask. A No. 6–32 stainless steel eye- um oven for 2 hours at 80 °C ±5 °C. After bolt is attached to the lid for posi- 2 hours, remove and place in a desic- tioning the basket in the extraction cator to cool to room temperature vessel. The positioning rod, approxi- (about 1 hour). After cooling, reweigh mately 18 inches long and made from 1/ the film pieces to the nearest 0.1 milli- 16 inch outside diameter 316 stainless gram. Calculate the percent hexane- steel welding rod or equivalent and extractables content from the weight hooked at both ends, is used to position loss of the original sample. Multiply the basket in the extraction apparatus. the result by 0.935 and compare with extraction limits in paragraph (c) of (g) Vacuum oven. Capable of main- this section. Repeat the above proce- taining 80 °C ±5 °C and a minimum of dure for successive samples. 635 millimeters of mercury pressure. Option 2. Transfer 2.5±0.05 grams of (h) Reagents. n-Hexane, reagent or the prepared 1-inch film sections into a spectrograde, aromatic free (less than 1 tared sample basket and accurately milligram per liter), minimum 85 per- weigh to the nearest 0.1 milligram. cent n-hexane. This reagent may be re- Carefully raise the condenser until the used until it contains a maximum of 1.5 hook on the positioning rod is above grams polyolefin extractables or has the neck of the 2-liter extraction ves- been used for 12 determinations. sel. The basket should be totally below (i) Procedure. Assemble the extraction the level of n-hexane solvent. Extract vessel, condenser, and magnetic stir the sample resin film for 2 hours and bar. Add n-hexane (1 liter) to the ex- then raise the basket above the solvent traction vessel and clamp the assembly level to drain momentarily. Remove into a water bath set at 49.5 °C ±0.5 °C. the basket and rinse the contents by Start the water flowing through the immersing several times in fresh n- jacket of the reflux condenser. Adjust hexane. Allow the basket to dry be- the air flow through the stirring motor tween rinsings. Remove the excess sol- to give a smooth and uniform stir rate. vent by briefly blowing the basket with Allow the n-hexane to preheat for 1 a stream of nitrogen or dry air. Place hour to bring the temperature to 49.5 the basket in the vacuum oven for 2 °C±0.5 °C. Temperature is a critical fac- hours at 80 °C ±5 °C. After 2 hours, re- tor in this analysis and it must not move and place in a desiccator to cool vary more than 1 °C. If the temperature to room temperature (about 1 hour). exceeds these limits, the test must be After cooling, reweigh the basket to discontinued and restarted. Blown, the nearest 0.1 milligram. Calculate compression molded, or extrusion cast the percent hexane extractables con- films can be tested. Ideally, the film tent from the weight loss of the origi- should be prepared by the same process nal sample. Multiply the result by 0.935 as will be used with the production and compare with extraction limits in resin. Using gloves and metal tweezers paragraph (c) of this section. Repeat to avoid sample contamination, cut the above procedure for successive about 2.7 grams of the prepared film (4 samples. The same solvent charge mils or less in thickness) into about 1- should remain clear and can be used for

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at least 12 determinations. Applica- (c) Procedure. Weigh 1 to 2 grams of tions of solvent reuse should be con- sample to the nearest 0.001 gram and firmed for each resin type before use. place in a 125-milliliter Pyrex reagent (4) Maximum soluble fraction in xy- bottle containing a 1-inch long tetra- lene—(i) Olefin copolymers described in fluoroethylene-resin-coated stirring paragraph (a)(3)(ii) of this section, poly- bar. Add 100 milliliters of solvent, set propylene, and poly(methylpen-tene). A the stopper in lightly, and place the sample is dissolved completely in xy- bottle in the heating mantle or alu- lene by heating and stirring in a bottle minum block maintained at a tempera- with little free space. The solution is ture of 120 °C, and stir with a magnetic allowed to cool without stirring, stirrer until the sample is completely whereupon the insoluble portion pre- dissolved. Remove the bottle from the cipitates and is filtered off; the total heat and allow it to cool 1 hour in the solids content of the filtrate is then de- air, without stirring. Then place the termined as a measure of the soluble bottle in a water bath maintained at 25 fraction. °C ±0.5 °C, and allow to stand 1 hour (a) Apparatus. (1) Pyrex (or equiva- without stirring. Next, remove the bot- lent) reagent bottle, 125-milliliter, tle from the water bath, shake, and glass-stoppered. pour part of the contents into the (2) Heating mantle of size for 150-mil- coarse-porosity fritted-glass funnel. liliter beaker (or suitable aluminum Apply suction, and draw 30–40 milli- block to fit the 125-milliter bottle de- liters of filtrate through, adding more scribed in paragraph (d)(4)(i)(a)(1) of slurry to the funnel, and catching the this section. filtrate in a large test tube. (If the (3) Magnetic stirrer for use under the slurry is hard to filter, add 10 grams of heating mantle (combination magnetic diatomaceous earth filter aid to the stirrer and hotplate may be used if alu- bottle and shake vigorously just prior minum block is used in place of heat- to the filtration.) Pipet a suitable ali- ing mantle). quot (preferably 20 milliliters) of the (4) Variable-voltage transformer, 7.5 filtrate into a tared aluminum dispos- amperes. able dish. Place the dish on a steam (5) Tetrafluoroethylene-resin-coated bath covered with a fresh sheet of alu- stirring bar, 1-inch long. minum foil and invert a short-stemmed (6) Constant temperature water bath 4-inch funnel over the dish. Pass nitro- maintained at 25 °C±0.5 °C. gen (heated if desired) down through (7) Aluminum dishes, 18 millimeters × the funnel at a rate sufficient to just 60 millimeters, disposable. ripple the surface of the solvent. When (8) Funnel, Buchner type, with the liquid has evaporated, place the coarse-porosity fritted disc, 30–60 milli- dish in a vacuum oven at 140 °C and meter diameter. less than 50 millimeters mercury pres- (b) Reagent. Xylene with antioxidant. sure for 2 hours. Cool in a desiccator Dissolve 0.020 gram of phenyl-b- naph- and weigh. (Note: If the residue value thylamine in 1 liter of industrial grade seems high, redry in the vacuum oven xylene having specific gravity 0.856– for one-half hour to ensure complete 0.867 (20 °C/20 °C) and boiling range 123 removal of all xylene solvent.) Calcula- °C–160 °C. tion:

Grams of residue 100 milliters ××=100 Percent soluble in xylene Grams of sample volume of aliquot in milliliters

(ii) Olefin copolymers described in para- and the total residue weighed as a graph (a)(3)(i) of this section and poly- measure of soluble fraction. ethylene. A sample is extracted in xy- (a) Apparatus—(1) Extraction appa- lene at reflux temperature for 2 hours ratus. Two-liter, straight-walled Pyrex and filtered. The filtrate is evaporated (or equivalent) resin kettles, fitted

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with ground-glass covers, are most con- idly cooled to 25 °C–30 °C by immersing venient for this purpose. The cover is in a cold water bath. Transfer the ket- equipped with a thermometer and an tle to a constant temperature bath set efficient reflux condenser. The kettle is to maintain 25 °C ±0.1 °C, and allow to fitted with an electric heating mantle equilibrate for a least 1 hour (may be of appropriate size and shape which is left overnight if convenient). Break up controlled by a variable-voltage trans- any precipitated polymers that may former. have formed, and decant the xylene so- (2) Constant temperature water bath. It lution successively through a fast filter must be large enough to permit immer- paper and then through a fritted-glass sion of the extraction kettle and set to filter into a tared 1-liter Erlenmeyer maintain 25 °C ±0.1 °C. flask, collecting only the first 450 mil- (3) Evaporating apparatus. Gas cover liliters—500 milliliters of filtrate (any consisting of a flat Pyrex crystallizing attempt to collect more of the xylene dish (190 millimeters × 100 millimeters) solution usually results in clogging the inverted to fit over a 1-liter beaker filter and risking losses). Reweigh the with 8-millimeter gas inlet tube sealed Erlenmeyer flask and calculate the through center and an outlet tube 1 weight of the filtrate obtained to the inch off center. The beaker with gas nearest 0.1 gram. Transfer the filtrate, cover is inserted in an electric heating quantitatively, from the Erlenmeyer mantle equipped with a variable-volt- flask to the 1-liter beaker, insert the age transformer. The outlet tube is at- beaker in its heating mantle, add a tached to an efficient condenser glass-coated magnetic stirring bar, and mounted on a receiving flask for sol- mount the gas cover in place, con- vent recovery and having an outlet for necting the inlet tube to the nitrogen connection to an aspirator pump. The source and the outlet to the condenser heating mantle (with the beaker) is of the receiving flask. Start a flow of mounted on a magnetic stirring device. nitrogen (2 to 3 liters per minute) into An infrared heat lamp is mounted the gas cover and connect an aspirator vertically 3–4 inches above the gas to the receiver using a free-flow rate cover to prevent condensation of the equivalent to 6–7 liters of air per solvent inside the cover. Make all con- minute. With the infrared lamp on, ad- nections with flexible tetrafluoro- just the voltage to the heating mantle ethylene tubing. to give a distillation rate of 12–13 milli- (b) Reagents—(1) Xylene. American liters per minute when the magnetic Chemical Society reagent grade that stirrer is revolving just fast enough to has been redistilled through a promote good boiling. When the vol- fractionating column to reduce the ume of solvent in the beaker has been nonvolatile residue. reduced to 30–50 milliliters, transfer (2) Nitrogen. High-purity dry nitrogen the concentrated extractive to a suit- containing less than 104 parts per mil- able weighing dish that has been pre- lion oxygen. viously tared (dry). Rinse the beaker (c) Procedure. Transfer 5 grams ±0.001 twice with 10–20 milliliter portions of gram of sample to the resin kettle, add fresh xylene, adding the rinsings to the 1,000 milliliters (840 grams) of xylene, weighing dish. Evaporate the remain- and clamp top in position after insert- der of the xylene on an electric ing a piece of glass rod to prevent hotplate set at low heat under the gas bumping during reflux. Start water cover with a stream of nitrogen di- flowing through the jacket of the rected toward the center of the dish. reflux condenser and apply full voltage Avoid any charring of the residue. (115 volts) to the heating mantle. When Transfer the weighing dish to a vacu- the xylene starts to boil, reduce the um desiccator at room temperature voltage to a level just sufficient to and allow to remain under reduced maintain reflux. After refluxing for at pressure for at least 12 hours (over- least 2 hours, disconnect the power night), after which determine the net source to the mantle, remove the ket- weight of the residue to the nearest tle, and allow to cool in air until the 0.0001 gram. Correct the result for non- temperature of the contents drops to 50 volatile solvent blank obtained by °C, after which the kettle may be rap- evaporating the equivalent amount of

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xylene under identical conditions. Cal- test conditions and procedures are as culate the weight of residue originally follows: present in the total weight of solvent (840 grams), using the appropriate fac- List of polymers Conditions/procedures tor based on the weight of filtrate Olefin copolymers described in para- Condition L, proce- evaporated. graph (a)(3)(i)(c)(2) of this section. dure A. (5) Viscosity average molecular weight Olefin copolymers described in para- Condition E, proce- olefin copolymers described in paragraphs graph (a)(3)(v) of this section. dure A. Olefin polymers described in para- Condition E, proce- (a)(3) (iii) and (iv) of this section. The graph (a)(2)(ii) of this section. dure A. viscosity average molecular weight Olefin polymers described in para- Condition E, proce- shall be determined from the kine- graph (a)(3)(vi) of this section. dure A. matic viscosity (using ASTM method D445–74, ‘‘Test for Kinematic Viscosity (8) Melting peak temperature. The melt of Transparent and Opaque Liquids’’ temperature of the olefin polymers de- (Revised 1974), which is incorporated by scribed in paragraph (a)(3)(ii) of this reference; copies are available from section shall be determined by ASTM American Society for Testing and Ma- method D 3418–82, ‘‘Standard Test terials (ASTM), 1916 Race Street, Method for Transition Temperatures of Philadelphia, PA 19103, or available for Polymers by Thermal Analysis,’’ which inspection at the Office of the Federal is incorporated by reference in accord- Register, 800 North Capitol Street, ance with 5 U.S.C. 552(a). The avail- NW., suite 700, Washington, DC 20408) of ability of this incorporation by ref- solutions of the copolymers in solvents erence is given in paragraph (d)(1) of and at temperatures as follows: this section. (i) Olefin polymers described in para- (9) Intrinsic viscosity. The intrinsic graph (a)(3)(iii) of this section in viscosity of the olefin polymers de- ° decahydronaphthalene at 135 C. scribed in paragraph (a)(3)(ii) of this (ii) Olefin polymers described in section shall be determined by ASTM paragraph (a)(3)(iv) of this section in method D 1601–78, ‘‘Standard Test ° tetrachloroethylene at 30 C. Method for Dilute Solution Viscosity (6) Mooney viscosity—olefin copolymers of Ethylene Polymers,’’ which is incor- described in paragraph (a)(3)(iii) of this porated by reference in accordance section. Mooney viscosity is determined with 5 U.S.C. 552(a). The availability of by ASTM method D1646–81, ‘‘Standard this incorporation by reference is given Test Method for Rubber—Viscosity and in paragraph (d)(1) of this section. Vulcanization Characteristics (Mooney Viscometer),’’ which is incorporated by (e) Olefin copolymers described in reference (the availability of this in- paragraph (a)(3) (i) of this section and corporation by reference is given in polyethylene, alone or in combination, paragraph (d)(1) of this section), using may be subjected to irradiation bom- the large rotor at a temperature of 100 bardment from a source not to exceed °C, except that a temperature of 127 °C 2.3 million volts intensity to cause mo- shall be used for those copolymers lecular crosslinking of the polymers to whose Mooney viscosity cannot be de- impart desired properties, such as in- termined at 100 °C. The apparatus con- creased strength and increased ability taining the sample is warmed for 1 to shrink when exposed to heat. minute, run for 8 minutes, and vis- (f) The olefin polymers identified in cosity measurements are then made. and complying with this section, when (7) Melt flow index. The melt flow used as components of the food-contact index of olefin polymers described surface of any article that is the sub- below shall be determined by ASTM ject of a regulation in parts 174, 175, method D–1238–82, ‘‘Standard Test 176, 177, 178, and § 179.45 of this chapter, Method for Flow Rates of Thermo- shall comply with any specifications plastics by Extrusion Plastometer,’’ and limitations prescribed by such reg- which is incorporated by reference in ulation for the article in the finished accordance with 5 U.S.C. 552(a). The form in which it is to contact food. availability of this incorporation by (g) The provisions of this section are reference is given in paragraph (d)(1) of not applicable to olefin polymers iden- this section. The olefin polymers and tified in § 175.105(c) (5) of this chapter

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and used in food-packaging adhesives List of substances Limitations complying with § 175.105 of this chapter. Lithium polysilicate containing For use only as a compo- [42 FR 14572, Mar. 15, 1977] not more than 20 weight per- nent of repeated-use cent silica, not more than 2.1 coatings not exceeding EDITORIAL NOTE: For FEDERAL REGISTER ci- percent lithium oxide and 0.030 millimeter (0.0012 tations affecting § 177.1520, see the List of having a maximum mole inch) in thickness where CFR Sections Affected, which appears in the ratio of Si02/Li20 of 8.5 to 1. the coatings are thermally cured at minimum sinter- Finding Aids section of the printed volume ing temperatures of 371 and on GPO Access. °C (700 °F). Lithium extractives shall not exceed § 177.1550 Perfluorocarbon resins. 1.55 milligrams per square decimeter (0.1 Perfluorocarbon resins identified in milligram per square inch) this section may be safely used as arti- of coating surface when tested in accordance with cles or components of articles intended paragraph (e)(2) of this to contact food, subject to the provi- section. sions of this section: Naphthalene sulfonic acid For use only: formaldehyde condensate, 1. As a component of re- (a) Identity. For the purpose of this sodium salt. peated-use coatings, section, perfluorocarbon resins are based on the those produced by: (1) The perfluorocarbon resin identified in paragraph homopolymerization and/or copolym- (a)(1) of this section, not erization of hexafluoropropylene and to exceed 0.030 milli- tetrafluoroethylene, and (2) the cometer (0.0012 inch) in thickness, and at a level polymerization of not to exceed 0.4 weight perfluoropropylvinylether and tetra- percent of the coating. fluoroethylene (CAS Reg. No. 26655–00– 2. As a component of repeated-use coatings, 5). The resins shall meet the extrac- based on the tives limitations in paragraph (d) of perfluorocarbon resin this section. identified in paragraph (a)(2) of this section, not (b) Optional components. The to exceed 0.10 millimeter perfluorocarbon resins identified in (0.004 inch) in thickness, and at a level not to ex- paragraph (a) of this section as well as ceed 0.4 weight percent articles or coating made from these of the coating. resins may include the following optional components except that the (c) Optional processing. Poly- tetra- resin identified in paragraph (a)(2) of fluoroethylene resins may be irradi- this section may not be used with the ated by either a cobalt-60 sealed optional component, lithium source, at a maximum dose of gamma polysilicate, mentioned in paragraph radiation not to exceed 7.5 megarads, (b)(4) of this section. or an electron beam at energy levels (1) Substances generally recognized not to exceed 2.5 million electron volts as safe (GRAS) in food or food pack- with a maximum dosage of 7.5 aging subject to any limitations cited megarads, to produce lubricant pow- on their use. ders having a particle diameter of not (2) Substances used in accordance more than 20 microns for use only as with a prior sanction or approval, sub- components of articles intended for re- ject to any limitations cited in the peated use in contact with food. prior sanction or approval. (d) Specifications—(1) Infrared identi- (3) Substances authorized under ap- fication. Perfluorocarbon resins can be plicable regulations in this part and in identified by their characteristic infra- parts 175 and 178 of this chapter and red spectra. subject to any limitations prescribed (2) Melt-viscosity. (i) The perfluoro- therein. carbon resins identified in paragraph (4) The following substances, subject (a)(1) of this section shall have a melt to any limitations prescribed: viscosity of not less than 104 poises at 380 °C (716 °F) as determined by ASTM method D1238–82, ‘‘Standard Test Meth- od for Flow Rates of Thermoplastics by

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Extrusion Plastometer,’’ which is in- of 6.45 square decimeters (100 square corporated by reference. Copies may be inches) or more and at least 1.27 milli- obtained from the American Society meters (0.05 inch) thick shall be ex- for Testing Materials, 1916 Race St., tracted at reflux temperatures for 2 Philadelphia, PA 19103, or may be ex- hours separately with distilled water, amined at the Office of the Federal 50 percent ethanol, n-heptane, and Register, 800 North Capitol Street, ethyl acetate. NW., suite 700, Washington, DC 20408. (2) Perfluorocarbon resins identified The melt viscosity of the in paragraphs (a)(1) and (2) of this sec- perfluorocarbon resins identified in tion and intended for use as coatings or paragraph (a)(1) of this section shall components of coatings shall meet not vary more than 50 percent within extractability limits prescribed in ° ° one-half hour at 380 C (716 F). paragraph (e)(3) of this section when (ii) Perfluorocarbon resins identified the resins in the form of coatings de- in paragraph (a)(2) of this section shall scribed in paragraphs (e)(2) (i) and (ii) have a melt viscosity of not less than of this section are extracted at reflux 104 poises at 372 °C (702 °F) as deter- temperatures for 2 hours separately mined by a more detailed method ti- with distilled water, 8 percent ethanol, tled ‘‘Determination of Melt Viscosity, and -heptane: Molecular Weight Distribution Index n and Viscosity Stability,’’ which is in- (i) Perfluorocarbon resin coatings corporated by reference. Copies are based on resins identified in paragraph available from the Center for Food (a)(1) of this section shall be applied to Safety and Applied Nutrition (HFS– both sides of a 0.025-millimeter (0.001 200), Food and Drug Administration, inch) thick aluminum foil to a thick- 5100 Paint Branch Pkwy., College Park, ness of 0.025 millimeter (0.001 inch) MD 20740, or available for inspection at after thermal curing at 399 °C (750 °F) the Office of the Federal Register, 800 for 10 minutes. If a primer is used, the North Capitol Street, NW., suite 700, total thickness of the primer plus top- Washington, DC 20408. coat shall equal 0.025 millimeter (0.001 (3) Thermal instability index. The ther- inch) after heat curing. mal instability index of the tetra- (ii) Perfluorocarbon resin coatings fluoroethylene homopolymer shall not based on resins identified in paragraph exceed 50 as determined by ASTM (a)(2) of this section shall be applied to method D1457–56T, ‘‘Test for Thermal both sides of a 0.025-millimeter (0.001 Instablility index of Tetrafluoro- inch) thick aluminum foil to a thick- ethylene Homopolymer’’ (Revised 1956), ness of 0.10 millimeter (0.004 inch) after which is incorporated by reference. thermal curing at 427 °C (800 °F) for 10 Copies are available from University minutes. If a primer is used, the total Microfilms International, 300 N. Zeeb thickness of the primer plus topcoat Rd., Ann Arbor, MI 48106, or available shall equal 0.10 millimeter (0.004 inch) for inspection at the Office of the Fed- after heat curing. eral Register, 800 North Capitol Street, (3) The extracted surfaces shall meet NW., suite 700, Washington, DC 20408. the following extractability limits: The requirements of this paragraph do (i) Total extractives not to exceed 3.1 not apply to polytetrafluoroethylene resin lubricant powders described in milligrams per square decimeter (0.2 paragraph (c) of this section. milligram per square inch). (e) Limitations. 1 (1) Perfluorocarbon- (ii) Fluoride extractives calculated as molded articles having a surface area fluorine not to exceed 0.46 milligram per square decimeter (0.03 milligram 1 A more detailed procedure of extraction per square inch). conditions is entitled, ‘‘Preparation of Ex- (f) Conditions of use. Perfluorocarbon tracts,’’ which is incorporated by reference. resins identified in paragraph (a)(2) of Copies are available from the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, the Federal Register, 800 North Capitol or available for inspection at the Office of Street, NW., suite 700, Washington, DC 20408.

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this section are limited to use as coat- phenylenecarbonyl-1,4-phenylene) res- ings or components of coatings for arti- ins (CAS Reg. No. 55088–54–5 and CAS cles intended for repeated food-contact Reg. No. 60015–05–6 and commonly reuse. ferred to as polyaryletherketone res- [43 FR 44834, Sept. 29, 1978, as amended at 47 ins) identified in paragraph (a) of this FR 11843, Mar. 19, 1982; 47 FR 14699, Apr. 6, section may be safely used as articles 1982; 49 FR 10109, Mar. 19, 1984; 50 FR 1502, or components of articles intended for Jan. 11, 1985; 54 FR 24898, June 12, 1989; 61 FR repeated use in contact with food, sub- 14481, Apr. 2, 1996] ject to the provisions of this section. (a) Identity. Polyaryletherketone res- § 177.1555 Polyarylate resins. ins consist of basic resins produced by Polyarylate resins (CAS Reg. No. reacting 4,4′-diphenoxy benzophenone 51706–10–6) may be safely used as arti- and terephthaloyl dichloride in such a cles or components of articles intended way that the finished resins have a for use in contact with food in accord- minimum weight average molecular ance with the following prescribed con- weight of 20,000 grams per mole, as de- ditions: termined by light scattering measure- (a) Identity. Polyarylate resins (1, 3- ments in sulfuric acid at room tem- benzenedicarboxylic acid, diphenyl perature. ester, polymer with diphenyl 1,4- (b) Optional adjuvant substances. The benzenedicarboxylate and 4-4′-(1- basic polyaryletherketone resins iden- methylethylidine) bis(phenol)) are tified in paragraph (a) of this section formed by melt polycondensation of may contain optional adjuvant sub- bisphenol-A with diphenylisophthalate stances required in the production of and diphenylterephthalate. such basic resins. These adjuvants may (b) Specifications. (1) The finished co- include substances used in accordance polymers shall contain from 70 to 80 with § 174.5 of this chapter and the fol- weight percent of polymer units de- lowing: rived from diphenylisophthalate and 20 (1) Benzoyl chloride, poly(tetrafluoro to 30 weight percent of polymer units ethylene). derived from diphenylterephthalate. (2) [Reserved] (2) Polyarylate resins shall have a minimum weight average molecular (c) Extractive limitations. The finished weight of 20,000. food-contact article yields net total ex- (3) Polyarylate resins may be identi- tractives in each extracting solvent fied by their characteristic infrared not to exceed 0.052 milligram per spectra. square inch (corresponding to 0.008 mil- (c) Extractive limitations. The finished ligram per square centimeter) of food- polyarylate resins in sheet form at contact surface, when extracted at least 0.5 millimeter (0.020 inch) thick, reflux temperature for 2 hours with the when extracted with water at 121 °C following solvents: Distilled water, 50 (250 °F) for 2 hours, shall yield total percent (by volume) ethyl alcohol in nonvolatile extractives not to exceed distilled water, 3 percent acetic acid 2.33 micrograms per square centimeter (by weight) in distilled water, and n- (15 micrograms per square inch) of the heptane. exposed resin surface. (d) In testing the finished food-con- (d) Limitations. Polyarylate resin ar- tact article made of ticles may be used in contact with all polyaryletherketone resin, use a sepa- foods except beverages containing rate test sample for each required ex- more than 8 volume percent ethanol tracting solvent. under conditions of use A through H, [61 FR 42381, Aug. 15, 1996] described in table 2 of § 176.170(c) of this chapter. § 177.1560 Polyarylsulfone resins. [52 FR 35540, Sept. 22, 1987] Polyarylsulfone resins (CAS Reg. No. 79293–56–4) may be safely used as arti- § 177.1556 Polyaryletherketone resins. cles or components of articles intended The poly(oxy-1,4-phenylenecarbonyl- for use in contact with food, at tem- 1,4-phenyleneoxy-1,4- peratures up to and including normal phenylenecarbonyl-1,4- baking temperatures, in accordance

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with the following prescribed condi- NOTE: In testing the finished polyaryl- tions: sulfone resin use a separate test sample for (a) Identity. Polyarylsulfone resins each required extracting solvent. are copolymers containing not more [50 FR 31046, July 24, 1985] than 25 percent of oxy-p-phenyleneoxy-p-phenylenesulfonyl-p-phenylene § 177.1570 Poly-1-butene resins and polymer units and not less than 75 per- butene/ethylene copolymers. cent of oxy-p-phenylenesulfonyl-p- The poly-1-butene resins and butene/ phenylene-oxy-p-phenylenesulfonyl-p- ethylene copolymers identified in this phenylene polymer units. The copoly- section may be safely used as articles mers have a minimum reduced vis- or components of articles intended for cosity of 0.40 deciliter per gram in 1- use in contact with food subject to the methyl-2-pyrrolidinone in accordance provisions of this section. with ASTM method D2857–70 (Re- (a) Identity. Poly-1-butene resins are approved 1977), ‘‘Standard Test Method produced by the catalytic polymeriza- for Dilute Solution Viscosity of Poly- tion of 1-butene liquid monomer. mers,’’ which is incorporated by ref- Butene/ethylene copolymers are pro- erence. Copies may be obtained from duced by the catalytic polymerization the American Society for Testing and of 1-butene liquid monomer in the pres- Materials, 1916 Race St., Philadelphia, ence of small amounts of ethylene PA 19103, or may be examined at the monomer so as to yield no higher than Office of the Federal Register, 800 a 6-weight percent concentration of North Capitol Street, NW., suite 700, polymer units derived from ethylene in Washington, DC 20408. the copolymer. (b) Poly- (b) Optional adjuvant substances. The Specifications and limitations. 1-butene resins and butene/ethylene co- basic polyarylsulfone resins identified polymers shall conform to the speci- in paragraph (a) of this section may fications prescribed in paragraph (b)(1) contain optional adjuvant substances of this section, and shall meet the required in the production of such extractability limits prescribed in basic copolymers. These optional adju- paragraph (b)(2) of this section. vant substances may include sub- (1) Specifications—(i) Infrared identi- stances permitted for such use by regu- fication. Poly-1-butene resins and lations in parts 170 through 179 of this butene/ethylene copolymers can be chapter, substances generally recog- identified by their characteristic infra- nized as safe in food, substances used in red spectra. accordance with a prior sanction of ap- (ii) Viscosity. Poly-1-butene resins and proval, and substances named in this the butene/ethylene copolymers have paragraph and further identified as re- an intrinsic viscosity 1.0 to 3.2 as deter- quired: mined by ASTM method D1601–78, Substances Limitations ‘‘Standard Test Method for Dilute So- lution Viscosity of Ethylene Poly- Sulfolane ..... Not to exceed 0.15 percent as residual sol- mers,’’ which is incorporated by ref- vent in the finished basic resin. erence. Copies may be obtained from the American Society for Testing Ma- (c) Extractive limitations. The finished terials, 1916 Race St., Philadelphia, PA polyarylsulfone resin when extracted 19103, or may be examined at the Office for 2 hours with the following solvents of the Federal Register, 800 North Cap- at the specified temperatures yields itol Street, NW., suite 700, Washington, total extractives in each extracting DC 20408. solvent not to exceed 0.008 milligram (iii) Density. Poly-1-butene resins per square centimeter of food-contact have a density of 0.904 to 0.920 gms/cm3, surface: distilled water at 121 °C (250 and butene/ethylene copolymers have a °F), 50 percent (by volume) ethyl alco- density of 0.890 to 0.916 gms/cm3 as de- hol in distilled water at 71.1 °C (160 °F), termined by ASTM method D1505–68 3 percent acetic acid in distilled water (Reapproved 1979), ‘‘Standard Test at 100 °C (212 °F), and n-heptane at 65.6 Method for Density of Plastics by the °C (150 °F). Density-Gradient Technique,’’ which is

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incorporated by reference. The avail- § 177.1580 Polycarbonate resins. ability of this incorporation by ref- Polycarbonate resins may be safely erence is given in paragraph (b)(1)(ii) of used as articles or components of arti- this section. cles intended for use in producing, (iv) Melt index. Poly-1-butene resins manufacturing, packing, processing, have a melt index of 0.1 to 24 and the preparing, treating, packaging, trans- butene/ethylene copolymers have a porting, or holding food, in accordance melt index of 0.1 to 20 as determined by with the following prescribed condi- ASTM method D1238–82, condition E, tions: ‘‘Standard Test Method for Flow Rates (a) Polycarbonate resins are poly- of Thermoplastics by Extrusion Plas- esters produced by: tometer,’’ which is incorporated by ref- (1) The condensation of 4,4′-iso- erence. The availability of this incor- propylidenediphenol and carbonyl chlo- poration by reference is given in para- ride to which may have been added cer- graph (b)(1)(ii) of this section. tain optional adjuvant substances re- (2) Limitations. Poly-1-butene resins quired in the production of the resins; and butene/ethylene copolymers for use or by in articles that contact food, and for (2) The reaction of molten 4,4′-iso- articles used for packing or holding propylidenediphenol with molten di- food during cooking shall yield no phenyl carbonate in the presence of the more than the following extractables: ′ (i) Poly-1-butene resins may be used disodium salt of 4,4 -isopro- as articles or components of articles pylidenediphenol. (3) The condensation of 4,4′-isopro- intended for use in contact with food, pylidenediphenol, carbonyl chloride, provided that the maximum and 0.5 percent weight maximum of extractables do not exceed 2.5 percent a2,a6-bis (6-hydroxy-m-tolyl) mesitol to by weight of the polymer when film or which may have been added certain op- molded samples are tested for 2 hours tional adjuvant substances required in at 50 °C (122 °F) in n-heptane. (ii) Butene/ethylene copolymers con- the production of branched taining no more than 6 percent by polycarbonate resins. weight of polymer units derived from (b) The optional adjuvant substances ethylene may be used as articles or required in the production of resins components of articles intended for produced by the methods described in contact with food under conditions of paragraph (a)(1) and (3) of this section use B, C, D, E, F, G, or H described in may include substances generally rec- table 2 of § 176.170(c) of this chapter, ognized as safe in food, substances used subject to the provisions of this section in accordance with a prior sanction or and provided that the maximum approval, and the following: extractables from test films 0.1 to 0.2 List of substances Limitations millimeter (0.004 to 0.008 inch) in thickness do not exceed 0.80 percent by p-tert-Butylphenol ...... Chloroform ...... weight of the polymer when extracted p-Cumylphenol (CAS Reg. For use only as a chain ter- in a soxhlet extractor for 6 hours with No. 599–64–4). minator at a level not to ex- refluxing 95 percent ethanol. ceed 5 percent by weight of the resin. (iii) Poly-1-butene resins may be used Ethylene dichloride. as articles or components of articles Heptane. intended for packaging or holding food Methylene chloride. during cooking, provided that the Monochlorobenzene ...... Not to exceed 500 p.p.m. as residual solvent in finished thickness of such polymers in the form resin. in which they contact food shall not Pentaerythritol tetrastearate For use only as a mold re- exceed 0.1 millimeter (0.004 inch) and (CAS Reg. No. 115–83–3). lease agent, at a level not to exceed 0.5 percent by yield maximum extractables of not weight of the finished resin. more than 2.5 percent by weight of the Phenol (CAS Reg. No. 108– polymer when films are extracted for 2 95–2). hours at 50 °C (122 °F) in n-heptane. Pyridine. Toluene: (CAS Reg. No. Not to exceed 800 parts per [42 FR 14572, Mar. 15, 1977, as amended at 49 108–88–3). million as residual solvent FR 10109, Mar. 19, 1984; 50 FR 31349, Aug. 2, in finished resin. Triethylamine. 1985]

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(c) Polycarbonate resins shall con- by CAS Reg. No. 114096–64–9 when pro- form to the specification prescribed in duced with the use of greater than 2 paragraph (c)(1) of this section and but not greater than 5 weight percent shall meet the extractives limitations p-cumylphenol (CAS Reg. No. 599–64–4), prescribed in paragraph (c)(2) of this as an optional adjuvant substance in section. accordance with paragraph (b)(2) of (1) Specification. Polycarbonate resins this section. can be identified by their char- (b) Optional adjuvants. The optional acteristic infrared spectrum. adjuvant substances required in the (2) Extractives limitations. The production of resins identified in para- polycarbonate resins to be tested shall graph (a) of this section may include: be ground or cut into small particles (1) Substances used in accordance that will pass through a U.S. standard with § 174.5 of this chapter. sieve No. 6 and that will be held on a (2) Substances identified in U.S. standard sieve No. 10. § 177.1580(b). (i) Polycarbonate resins, when ex- (3) Substances regulated in tracted with distilled water at reflux § 178.2010(b) of this chapter for use in temperature for 6 hours, shall yield polycarbonate resins complying with total extractives not to exceed 0.15 per- § 177.1580: cent by weight of the resins. (ii) Polycarbonate resins, when ex- Provided, That the substances are used tracted with 50 percent (by volume) in accordance with any limitation on ethyl alcohol in distilled water at concentration, conditions of use, and reflux temperature for 6 hours, shall food types specified in § 178.2010(b) of yield total extractives not to exceed this chapter. 0.15 percent by weight of the resins. (c) Polyestercarbonate resins shall (iii) Polycarbonate resins, when ex- conform to the specifications pre- tracted with n-heptane at reflux tem- scribed in paragraph (c)(1) of this sec- perature for 6 hours, shall yield total tion and shall meet the extractive lim- extractives not to exceed 0.15 percent itations prescribed in paragraph (c)(2) by weight of the resins. of this section. [42 FR 14572, Mar. 15, 1977, as amended at 46 (1) Specifications. Polyestercarbonate FR 23227, Apr. 24, 1981; 49 FR 4372, Feb. 6, resins identified in paragraph (a) of 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656, this section can be identified by their Aug. 8, 1988; 59 FR 43731, Aug. 25, 1994] characteristic infrared spectrum. The resins shall comply with either or both § 177.1585 Polyestercarbonate resins. of the following specifications: Polyestercarbonate resins may be (i) The solution intrinsic viscosity of safely used as articles or components the polyestercarbonate resins shall be of articles intended for use in pro- a minimum of 0.44 deciliter per gram, ducing, manufacturing, packing, proc- as determined by a method entitled essing, preparing, treating, packaging, ‘‘Intrinsic Viscosity (IV) of Lexan or holding food, in accordance with the Polyestercarbonate Resin by a Single following prescribed conditions: Point Method Using Dichloromethane (a) Polyestercarbonate resins (CAS as the Solvent,’’ developed by the Gen- Reg. No. 71519–80–7) are produced by the eral Electric Co., September 20, 1985, condensation of 4,4′- which is incorporated by reference in isopropylidenediphenol, carbonyl chlo- accordance with 5 U.S.C. 552(a) and 1 ride, terephthaloyl chloride, and CFR part 51. Copies are available from isophthaloyl chloride such that the fin- the Office of Premarket Approval, Cen- ished resins are composed of 45 to 85 ter for Food Safety and Applied Nutri- molepercent ester, of which up to 55 tion (HFS–215), Food and Drug Admin- mole-percent is the terephthaloyl iso- istration, 5100 Paint Branch Pkwy., mer. The resins are manufactured College Park, MD 20740, or may be ex- using a phthaloyl chloride/carbonyl amined at the Center for Food Safety chloride mole ratio of 0.81 to 5.7/1 and and Applied Nutrition’s Library, Food isophthaloyl chloride/terephthaloyl and Drug Administration, 5100 Paint chloride mole ratio of 0.81/1 or greater. Branch Pkwy., College Park, MD 20740, The resins are also properly identified or at the Office of the Federal Register,

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800 North Capitol St. NW., suite 700, of articles intended for use in contact Washington, DC; or with bulk quantities of dry food of the (ii) A minimum weight-average mo- type identified in § 176.170(c) of this lecular weight of 27,000, as determined chapter, table 1, under Type VIII, in ac- by gel permeation chromatography cordance with the following prescribed using polystyrene standards. conditions: (2) Extractives limitations. The (a) For the purpose of this section, polyestercarbonate resins to be tested polyester elastomers are those pro- shall be ground or cut into small par- duced by the ester exchange reaction ticles that will pass through a U.S. when one or more of the following standard sieve No. 6 and that will be phthalates—dimethyl terephthalate, held on U.S. standard sieve No. 10. dimethyl orthophthalate, and dimethyl (i) Polyestercarbonate resins, when isophthalate—is made to react with extracted with distilled water at reflux alpha-hydroomega-hydroxypoly temperature for 6 hours, shall yield (oxytetramethylene) and/or 1,4- total nonvolatile extractives not to ex- butanediol such that the finished elas- ceed 0.005 percent by weight of the res- tomer has a number average molecular ins. weight between 20,000 and 30,000. (ii) Polyestercarbonate resins, when (b) Optional adjuvant substances em- extracted with 50 percent (by volume) ployed in the production of the poly- ethyl alcohol in distilled water at ester elastomers or added thereto to reflux temperature for 6 hours, shall impart desired technical or physical yield total nonvolatile extractives not properties may include the following to exceed 0.005 percent by weight of the substances: resins. (iii) Polyestercarbonate resins, when List of substances Limitations extracted with n-heptane at reflux 4,4′ - Bis (alpha, alpha-di- For use only as an anti- temperature for 6 hours, shall yield methyl-benzyl) oxidant. total nonvolatile extractives not to ex- diphenylamine. ceed 0.002 percent by weight of the res- Tetrabutyl titanate ...... For use only as a catalyst. ins. (3) Residual methylene chloride levels in (c) An appropriate sample of the fin- polyestercarbonate resins. Polyester- ished polyester elastomer in the form carbonate resin articles in the finished in which it contacts food when sub- form shall not contain residual meth- jected to ASTM method D968–81, ylene chloride in excess of 5 parts per ‘‘Standard Test Methods for Abrasion million as determined by a method ti- Resistance of Organic Coatings by the tled ‘‘Analytical Method for Deter- Falling Abrasive Tester,’’ which is in- mination of Residual Methylene Chlo- corporated by reference (copies may be ride in Polyestercarbonate Resin,’’ de- obtained from the American Society veloped by the General Electric Co., for Testing Materials, 1916 Race St., July 23, 1991, which is incorporated by Philadelphia, PA 19103, or may be ex- reference in accordance with 5 U.S.C. amined at the Office of the Federal 552(a) and 1 CFR part 51. Copies are Register, 800 North Capitol Street, available from the Center for Food NW., suite 700, Washington, DC 20408), Safety and Applied Nutrition (HFS– using No. 50 emery abrasive in lieu of 200), Food and Drug Administration, Ottawa sand, shall exhibit an abrasion 5100 Paint Branch Pkwy., College Park, coefficient of not less than 100 liters MD 20740, or may be examined at the per mil of thickness. Office of the Federal Register, 800 [42 FR 14572, Mar. 15, 1977, as amended at 49 North Capitol Street, NW., suite 700, FR 10109, Mar. 19, 1984] Washington, DC. [57 FR 3940, Feb. 3, 1992, as amended at 64 FR § 177.1595 Polyetherimide resin. 27178, May 19, 1999] The polyetherimide resin identified in this section may be safely used as an § 177.1590 Polyester elastomers. article or component of an article in- The polyester elastomers identified tended for use in contact with food, in paragraph (a) of this section may be subject to the provisions of this sec- safely used as the food-contact surface tion.

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(a) Identity. For the purpose of this (a) For the purpose of this section, section, the polyetherimide resin is 1,3- carboxyl-modified polyethylene resins isobenzofurandione, 5,5′[(1-methyl- consist of basic polymers produced ethylidene)bis(4,1-phenyleneoxy)] bis- when ethylene-methyl acrylate basic polymer with 1,3-benzenediamine (CAS copolymers, containing no more than Reg. No. 61128–46–9), and is derived from 25 weight percent of polymer units de- the condensation reaction of m- rived from methyl acrylate, are made phenylenediamine and bisphenol A- to react in an aqueous medium with dianhydride. one or more of the following sub- (b) Optional adjuvants. The basic stances: polymer identified in paragraph (a) of Ammonium hydroxide. this section may contain optional adju- Calcium carbonate. vant substances required in the produc- Potassium hydroxide. tion of basic resins or finished food- Sodium hydroxide. contact articles. The optional adjuvant (b) The finished food-contact article, substances required in the production when extracted with the solvent or sol- of the basic polymer may include sub- vents characterizing the type of food stances permitted for such use by ap- and under the conditions of time and plicable regulations as set forth in part temperature characterizing the condi- 174 of this chapter. tions of its intended use as determined (c) Specifications and extractives limita- from tables 1 and 2 of § 176.170(c) of this tions—(1) Specifications. Polyetherimide chapter, yields total extractives in resin identified in paragraph (a) of this each extracting solvent not to exceed section shall have an intrinsic vis- 0.5 milligram per square inch of food- cosity in chloroform at 25 °C (77 °F) of contact surface as determined by the not less than 0.35 deciliter per gram as methods described in § 176.170(d) of this determined by a method titled ‘‘In- chapter; and if the finished food-con- trinsic Viscosity of ULTEM tact article is itself the subject of a Polyetherimide Using Chloroform as regulation in parts 174, 175, 176, 177, 178, the Solvent,’’ which is incorporated by and § 179.45 of this chapter, it shall also reference. Copies are available from comply with any specifications and the Center for Food Safety and Applied limitations prescribed for it by that Nutrition (HFS–200), Food and Drug regulation. In testing the finished food- Administration, 5100 Paint Branch contact articles, a separate test sample Pkwy., College Park, MD 20740, or is to be used for each required extract- available for inspection at the Office of ing solvent. the Federal Register, 800 North Capitol (c) The provisions of paragraph (b) of Street, NW., suite 700, Washington, DC this section are not applicable to 20408. carboxyl-modified polyethylene resins (2) Extractive limitations. Extractive used in food-packaging adhesives com- limitations are applicable to the basic plying with § 175.105 of this chapter. polyetherimide resin in the form of molded discs of thickness 0.16 centi- § 177.1610 Polyethylene, chlorinated. meter (0.063 inch). The resin discs when Chlorinated polyethylene identified ° extracted with distilled water at 121 C in this section may be safely used as ° (250 F) for 2 hours yield total nonvola- articles or components of articles that tile extractives of not more than 12.3 contact food, except for articles used micrograms per square centimeter. for packing or holding food during [50 FR 31351, Aug. 2, 1985; 50 FR 35535, Sept. cooking, subject to the provisions of 3, 1985] this section. (a) For the purpose of this section, § 177.1600 Polyethylene resins, chlorinated polyethylene consists of carboxyl modified. basic polymers produced by the direct Carboxyl-modified polyethylene res- chlorination of polyethylene con- ins may be safely used as the food-conforming to the density, maximum n- tact surface of articles intended for use hexane extractable fraction, and max- in contact with food in accordance imum xylene soluble fraction specifica- with the following prescribed conditions prescribed under item 2.1 of the tions: table in § 177.1520(c). Such chlorinated

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polyethylene contains a maximum of 60 vents characterizing the type of food percent by weight of total chlorine, as and under conditions of time and tem- determined by ASTM 1method D1303–55 perature characterizing the conditions (Reapproved 1979), ‘‘Standard Test of its intended use as determined from Method for Total Chlorine in Vinyl tables 1 and 2 of § 176.170(c) of this chap- Chloride Polymers and Copolymers,’’ ter, yields fluoride ion not to exceed 5 which is incorporated by reference parts per million calculated on the (copies may be obtained from the basis of the volume of food held by the American Society for Testing Mate- food-contact article. rials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office [48 FR 39057, Aug. 29, 1983] of the Federal Register, 800 North Cap- itol Street, NW., suite 700, Washington, § 177.1620 Polyethylene, oxidized. DC 20408), and has a 7.0 percent max- Oxidized polyethylene identified in imum extractable fraction in n-hexane paragraph (a) of this section may be at 50 °C, as determined by the method safely used as a component of food-con- described in § 177.1520(d)(3)(ii). tact articles, in accordance with the (b) Chlorinated polyethylene may be following prescribed conditions: used in contact with all types of food, (a) Oxidized polyethylene is the basic except that when used in contact with resin produced by the mild air oxida- fatty food of Types III, IV–A, V, VII–A, tion of polyethylene conforming to the and IX described in table 1 of § 176.170(c) density, maximum n-hexane extract- of this chapter, chlorinated poly- able fraction, and maximum xylene ethylene is limited to use only as a soluble fraction specifications pre- modifier admixed at levels not exceed- scribed under item 2.3 of the table in ing 15 weight percent in plastic articles § 177.1520(c). Such oxidized polyethylene prepared from polyvinyl chloride and/ has a minimum number average molec- or from vinyl chloride copolymers com- ular weight of 1,200, as determined by plying with § 177.1980. high temperature vapor pressure os- [42 FR 14572, Mar. 15, 1977, as amended at 49 mometry, contains a maximum of 5 FR 10109, Mar. 19, 1984; 59 FR 14550, Mar. 29, percent by weight of total oxygen, and 1994] has an acid value of 9 to 19. (b) The finished food-contact article, § 177.1615 Polyethylene, fluorinated. when extracted with the solvent or sol- Fluorinated polyethylene, identified vents characterizing the type of food in paragraph (a) of this section, may be and under the conditions of time and safely used as food-contact articles in temperature characterizing the condi- accordance with the following pre- tions of its intended use as determined scribed conditions: from tables 1 and 2 of § 176.170(c) of this (a) Fluorinated polyethylene food- chapter, yields net acidified chloro- contact articles are produced by modi- form-soluble extractives not to exceed fying the surface of polyethylene arti- 0.5 milligram per square inch of food- cles through action of fluorine gas in contact surface when tested by the combination with gaseous nitrogen as methods described in § 177.1330(c), ex- an inert diluent. Such modification af- cept that net acidified chloroform-solu- fects only the surface of the polymer, ble extractives from paper and paper- leaving the interior unchanged. board complying with § 176.170 of this Fluorinated polyethylene articles are chapter may be corrected for wax, pet- manufactured from basic resins con- rolatum, and mineral oil as provided in taining not less than 85 weight-percent § 176.170(d) (5)(iii)(b) of this chapter. If of polymer units derived from ethylene the finished food-contact article is and identified in § 177.1520 (a)(2) and itself the subject of a regulation in (3)(i). parts 174, 175, 176, 177, 178 and § 179.45 of (b) Fluorinated polyethylene articles this chapter, it shall also comply with conform to the specifications and use any specifications and limitations pre- limitations of § 177.1520(c), items 2.1 and scribed for it by such regulations. 3.1. (NOTE: In testing the finished food-con- (c) The finished food-contact article, tact article, use a separate test sample when extracted with the solvent or sol- for each extracting solvent.)

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(c) The provisions of this section are (d) The quantity of any optional sub- not applicable to oxidized polyethylene stance employed in the production of used as provided in §§ 175.105 and 176.210 polyethylene phthalate plastics does of this chapter, and § 177.2800. The pro- not exceed the amount reasonably revisions of paragraph (b) of this section quired to accomplish the intended are not applicable to oxidized poly- physical or technical effect or any lim- ethylene used as provided in §§ 175.125 itations further provided. Any sub- and 176.170(a)(5) of this chapter and stance employed in the production of § 177.1200. polyethylene phthalate plastics that is the subject of a regulation in parts 174, § 177.1630 Polyethylene phthalate 175, 176, 177, 178 and 179 of this chapter polymers. conforms with any specification in Polyethylene phthalate polymers such regulation. identified in this section may be safely (e) Substances employed in the pro- used as, or components of plastics duction of polyethylene phthalate plas- (films, articles, or fabric) intended for tics include: use in contact with food in accordance (1) Substances generally recognized with the following prescribed condi- as safe in food. tions: (2) Substances subject to prior sanc- (a) Polyethylene phthalate films con- tion or approval for use in poly- sist of a base sheet of ethylene ethylene phthalate plastics and used in terephthalate polymer, ethylene accordance with such sanction or ap- terephthalate-isophthalate copolymer, proval. or ethylene-1,4-cyclohexylene dimethylene terephthalate copoly- (3) Substances which by regulation in esters described in § 177.1315(b)(3), to parts 174, 175, 176, 177, 178 and § 179.45 of which have been added optional sub- this chapter may be safely used as stances, either as constituents of the components of resinous or polymeric base sheet or as constituents of coat- food-contact surfaces subject to the ings applied to the base sheet. provisions of such regulation. (b) Polyethylene phthalate articles (4) Substances identified in this para- consist of a base polymer of ethylene graph (e)(4) subject to the limitations terephthalate polymer, or ethylene-1,4- prescribed: cyclohexylene dimethylene terephthalate copolyesters described in LIST OF SUBSTANCES AND LIMITATIONS § 177.1315(b)(3), to which have been (i) Base sheet: added optional substances, either as Ethylene terephthalate copolymers: Pre- constituents of the base polymer or as pared by the condensation of dimethyl constituents of coatings applied to the terephthalate or terephthalic acid with base polymer. ethylene glycol, modified with one or more (c)(1) Polyethylene phthalate of the following: Azelaic acid, dimethyl spunbonded nonwoven fabric consist of azelate, dimethyl sebacate, sebacic acid. continuous filaments of ethylene Ethylene terephthalate copolymers: Pre- terephthalate polymer and ethylene pared by the condensation of dimethyl terephthalate-isophthalate copolymer terephthalate or terephthalic acid with ethylene glycol, modified with one or more to which may have been added optional of the following: Azelaic acid, dimethyl adjuvant substances required in their azelate, dimethyl sebacate, sebacic acid, preparation and finishing. pyromellitic dianhydride. The level of (2) The ethylene terephthalate- pyromellitic dianhydride shall not exceed isophthalate copolymer component of 0.5 percent by weight of the finished co- the fabric shall not exceed 25 percent polymer which may be used under condi- by weight. The filaments may be blend- tions of use E through H as described in ed with other fibers regulated for the table 2 of § 176.170(c) of this chapter. specific use and the spunbonded fabric Ethylene terephthalate-isophthalate copolymers: Prepared by the condensation of may be further bonded by application dimethyl terephthalate or terephthalic of heat and/or pressure. acid and dimethyl isophthalate or iso- (3) The fabric shall be used only in phthalic acid with ethylene glycol. The accordance with paragraph (i) of this finished copolymers contain either: section. (a) 77 to 83 weight percent or

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(b) At least 97 weight percent of polymer Acrylonitrile. units derived from ethylene Methacrylonitrile. terephthalate. Vinyl chloride. (ii) Base sheet and base polymer: Itaconic acid. Ethylene-1,4-cyclohexylene dimethylene Styrene-maleic anhydride resin, partial 2- terephthalate copolyesters described in butoxyethyl ester, ammonium salt (CAS § 177.1315(b)(3). Reg. No. 68890–80–2). For use only as a coat- Ethylene terephthalate polymer: Prepared ing for polyethylene phthalate films com- by the condensation of dimethyl plying with paragraph (a) of this section, terephthalate and ethylene glycol. at levels not to exceed 0.025 gram per Ethylene terephthalate polymer: Prepared square meter (0.016 milligram per square by the condensation of terephthalic acid inch) of the film, in contact with food of and ethylene glycol. types VIII and IX in table 1 of § 176.170(c) of this chapter, under use conditions E, F, (iii) Coatings: and G in table 2 of § 176.170(c) of this chap- Acrylic copolymers (CAS Reg. No. 30394–86– ter. 6): Prepared by reaction of ethyl acrylate (CAS Reg. No. 140–88–5), methyl methacry- (iv) Emulsifiers: late (CAS Reg. No. 80–62–6), and Sodium dodecylbenzenesulfonate: As an ad- methacrylamide (CAS Reg. No. 79–39–0) juvant in the application of coatings to the blended with melamine-formaldehyde resin base sheet or base polymer. (CAS Reg. No. 68002–20–0). For use in coat- Sodium lauryl sulfate: As an adjuvant in the ings for polyethylene phthalate films com- application of coatings to the base sheet or plying with paragraph (a) of this section.– base polymer. Ethylene azelate-terephthalate copolymer: 2-Sulfoethyl methacrylate, sodium salt (CAS The copolymer, dissolved in 1,1,2-trichloro- Reg. No. 1804–87–1). For use only in copoly- ethane and/or methylene chloride, may be mer coatings on polyethylene phthalate used as a heat-activated sealant on poly- film under conditions of use E, F, and G de- ethylene terephthalate film intended for scribed in table 2 of § 175.300(d) of this chap- sealing polyethylene terephthalate pouch- ter, and limited to use at a level not to ex- es that are used as containers of either ceed 2.0 percent by weight of the dry co- nonalcoholic beverages or alcoholic bev- polymer coating. erages containing not more than 15 percent ethyl alcohol. The copolymer has a (v) Modifier: terephthalate/azelate molecular ratio of 1,4-Benzenedicarboxylic acid, dimethyl ester, 1.25/1.00 and a relative viscosity of not less polymer with 1,4-butanediol and a-hydro- than 1.5 as determined by a method title omega-hydroxypoly(oxy-1,4-butanediyl) ‘‘General Procedure of Determining the CAS Reg. No. 9078–71–1) meeting the fol- Relative Viscosity of Resin Polymers,’’ lowing specifications: which is incorporated by reference. Copies Melting point: 200° to 215 °C as determined are available from the Center for Food by ASTM method D2117–82, ‘‘Standard Safety and Applied Nutrition (HFS–200), Test Method for Melting Point of Food and Drug Administration, 5100 Paint Semicrystalline Polymers by the Hot Branch Pkwy., College Park, MD 20740, or Stage Microscopy Method,’’ which is in- available for inspection, at the Office of the Federal Register, 800 North Capitol corporated by reference. Copies may be Street, NW., suite 700, Washington, DC obtained from the American Society for 20408. Total residual copolymer solvent Testing Materials, 1916 Race St., Phila- (1,1,2-trichloroethane and/or methylene delphia, PA 19103, or may be examined at chloride) shall not exceed 0.13 milligram the Office of the Federal Register, 800 per square inch of film, and food contact of North Capitol Street, NW., suite 700, the film shall be limited to not more than Washington, DC 20408. 1 square inch per 250 grams of beverage. Density: 1.15 to 1.20 as determined by ASTM 2-Ethylhexyl acrylate copolymerized with method D1505–68 (Reapproved 1979), one or more of the following: ‘‘Standard Test Method for Density of Acrylonitrile. Plastics by the Density-Gradient Tech- Methacrylonitrile. nique,’’ which is incorporated by ref- Methyl acrylate. erence. Copies may be obtained from the Methyl methacrylate. American Society for Testing Materials, Itaconic acid. 1916 Race St., Philadelphia, PA 19103, or Vinylidene chloride copolymerized with one may be examined at the Office of the or more of the following: Federal Register, 800 North Capitol Methacrylic acid and its methyl, ethyl, Street, NW., suite 700, Washington, DC propyl, butyl, or octyl esters. 20408. Acrylic acid and its methyl, ethyl, propyl, The modifier is used at a level not to ex- butyl, or octyl esters. ceed 5 percent by weight of polyethylene

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terephthalate film. The average thick- of food contact surface exposed to the ness of the finished film shall not exceed solvent. 0.016 millimeter (0.0006 inch). (2) Conditions of use. The plastics are Hexanedioic acid polymer with 1,3- benzenedimethanamine (CAS Reg. No. used for packaging, transporting, or 25718–70–1) meeting the specifications in holding alcoholic beverages that do not § 177.1500(b), item 10, when tested by the exceed 50 percent alcohol by volume. methods given in § 177.1500(c). The modi- (h) Uncoated polyethylene phthalate fier is used in polyethylene terephthalate plastics consisting of a base sheet or at a level not to exceed 30 percent by base polymer prepared as prescribed weight of the polyethylene from substances identified in para- terephthalate. Chloroform-soluble extractives shall not graphs (e)(4)(i) and (ii) of this section exceed 0.08 milligram/centimeter 2 (0.5 and conforming with the specifications milligram/inch 2) of food-contact surface prescribed in paragraph (h)(1) of this of the modified polyethylene section are used as provided in para- terephthalate article when exposed to graph (h)(2) of this section: the following solvents at temperatures (1) Specifications. (i) The food contact and times indicated: ° ° surface, when exposed to distilled (a) Distilled water at 49 C (120 F) for 24 ° hours; water at 250 F for 2 hours yields chlo- (b) n-Heptane at 49 °C (120 °F) for 24 hours; roform-soluble extractives not to ex- (c) 8 percent ethyl alcohol at 49 °C (120 °F) ceed 0.02 milligram/inch 2 of food con- for 24 hours. tact surface exposed to the solvent; and For use in contact with all types of foods (ii) The food contact surface, when except (a) those containing more than 8 exposed to n-heptane at 150 °F for 2 percent alcohol, or (b) those at temperatures over 49 °C (120 °F). hours, yields chloroform-soluble extractives not to exceed 0.02 milligram/ (f) Polyethylene phthalate plastics inch 2 of food contact surface exposed conforming with the specifications pre- to the solvent. scribed in paragraph (f)(1) of this sec- (2) Conditions of use. The plastics are tion are used as provided in paragraph used to contain foods during oven bak- (f)(2) of this section: ing or oven cooking at temperatures (1) Specifications. (i) The food contact above 250 °F. surface, when exposed to distilled (i) Polyethylene phthalate fabric, ° water at 250 F for 2 hours, yields chlo- identified in paragraph (c) of this sec- roform-soluble extractives not to ex- tion and conforming with the specifica- 2 ceed 0.5 mg/in of food contact surface tions prescribed in paragraph (i)(1) of exposed to the solvent; and this section, is used only as provided in (ii) The food contact surface, when paragraph (i)(2) of this section. exposed to n-heptane at 150 °F for 2 (1) Specifications. Chloroform-soluble hours, yields chloroform-soluble ex- extractives shall not exceed 0.2 milli- tractives not to exceed 0.5 mg/in2 of gram/inch 2 of food-contact surface food contact surface exposed to the sol- when exposed to the following solvents vent. at temperatures and times indicated: (2) Conditions of use. The plastics are (i) Distilled water at 212 °F for 2 used for packaging, transporting, or hours. holding food, excluding alcoholic bev- ° erages, at temperatures not to exceed (ii) n-Heptane at 150 F for 2 hours. ° 250 °F. (iii) 50 percent ethyl alcohol at 120 F (g) Polyethylene phthalate plastics for 24 hours. conforming with the specifications pre- (2) Conditions of use. The plastics are scribed in paragraph (g)(1) of this sec- intended for: tion are used as provided in paragraph (i) Dry food contact. (g)(2) of this section. (ii) Bulk food (excluding alcoholic (1) Specifications. (i) The food contact beverages) repeated use applications, surface meets the specifications in including filtration, at temperatures paragraph (f)(1) of this section; and not exceeding 212 °F. (ii) The food contact surface when ex- (iii) Filtration of bulk alcoholic bev- posed to 50 percent ethyl alcohol at 120 erages, not exceeding 50 percent alco- °F for 24 hours, yields chloroform-solu- hol by volume, at temperatures not ex- ble extractives not to exceed 0.5 mg/in2 ceeding 120 °F.

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(j) Polyethylene phthalate plastics, (b) Optional adjuvant substances. The composed of ethylene terephthalate- poly(phenyleneterephthalamide) resins isophthalate containing a minimum of identified in paragraph (a) of this sec- 98 weight percent of polymer units de- tion may contain the following op- rived from ethylene terephthalate, or tional adjuvant substances, subject to ethylene-1,4-cyclohexylene any limitation on their use: dimethylene terephthalate copoly- (1) Optional adjuvant substances au- esters described in § 177.1315(b)(3), con- thorized for this use in accordance with forming with the specifications pre- § 174.5 of this chapter. scribed in paragraph (j)(1) of this sec- (2) Optional finish components, total tion, are used as provided in paragraph weight not to exceed 1 percent by (j)(2) of this section. weight of the base polymer, as follows: (1) Specifications. (i) The food contact surface meets the specifications in List of substances Limitations paragraph (f)(1) of this section and Diundecylphthalate (CAS (ii)(a) Containers with greater than 500 Reg. No. 3648–20–2). Mono- and dipotassium salts mL capacity. The food-contact surface of lauryl phosphate (CAS when exposed to 95 percent ethanol at Reg. No. 39322–78–6). 120 °F for 24 hours should not yield o-Phenylphenol (CAS Reg. For use as a fungicide for fin- No. 90–43–7). ish coating materials. Not chloroform-soluble extractives in ex- to exceed 0.01 percent by cess of 0.005 mg/in 2. weight of the base poly- (b) Containers with less than or equal to mer. Poly(oxyethylene/ 500 mL capacity. The food contact sur- oxypropylen- face when exposed to 95 percent eth- e)monobutylether (CAS anol at 120 °F for 24 hours should not Reg. No. 9038–95–3). yield chloroform-soluble extractives in Poly(oxyethylene) mono(nonylphenyl)ether 2 excess of 0.05 mg/in . (CAS Reg. No. 9019–45– (2) Conditions of use. The plastics are 9). used for packaging, transporting, or Polyvinyl methylether (CAS Reg. No. 9003–09–2). holding alcoholic foods that do not ex- Poly(oxyethylene) sorbitol ceed 95 percent alcohol by volume. monolaurate tetraoleate (CAS Reg. No. 71243–28– [42 FR 14572, Mar. 15, 1977, as amended at 42 2). FR 18611, Apr. 8, 1977; 44 FR 40886, July 13, Poly(oxyethylene) sorbitol 1979; 45 FR 6541, Jan. 29, 1980; 47 FR 11844, hexaoleate (CAS Reg. No. Mar. 19, 1982; 47 FR 53346, Nov. 26, 1982; 48 FR 57171–56–9). ′ 30361, July 1, 1983; 49 FR 10110, Mar. 19, 1984; 4,4 -Butylidenebis (6-tert- For use only as an oxidation butyl-m-cresol) (CAS Reg. inhibitor for finish coating 50 FR 31047, July 24, 1985; 51 FR 3772, Jan. 30, No. 85–60–9). materials. Not to exceed 1986; 52 FR 32917, Sept. 1, 1987; 54 FR 15750, 0.01 percent by weight of Apr. 19, 1989; 54 FR 24898, June 12, 1989; 60 FR the base polymer. 57927, Nov. 24, 1995; 60 FR 61654, Dec. 1, 1995; 61 FR 46718, Sept. 5, 1996] (c) Specifications. (1) Poly(phenyleneterephthalamide) resins § 177.1632 Poly (phenyleneterephthala- in the form of continuous filament mide) resins. yarns or fibers that have been scoured Poly(phenyleneterephthalamide) resin accordance with paragraph (d)(1) of ins identified in paragraph (a) of this this section, when refluxed in a 50 per- section may be safely used as articles cent ethanol/water mixture for 24 or components of articles intended for hours, yields total extractables not ex- repeated contact with food. ceeding 0.5 percent by weight of the (a) Identity. For the purpose of this sample. section, the poly(phenylene- (2) Poly(phenyleneterephthalamide) terephthalamide) resins (CAS Reg. No. resins in the form of pulp, when 26125–61–1) are produced by the polym- refluxed in a 50 percent ethanol/water erization of terephthalolyl chloride mixture for 24 hours, yields total with p-phenylenediamine. The extractables not exceeding 0.65 percent poly(phenyleneterephthalamide) resin by weight of the sample. fibers and yarns may contain optional (d) Conditions of use. (1) adjuvant substances required in their Poly(phenyleneterephthalamide) resins preparation and finishing. in the form of continuous filament

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yarns and fibers may be used as compo- erally recognized as safe in indirect ad- nents of articles intended for repeated ditives, and substances used in accord- use in contact with food at tempera- ance with prior sanction or approval. tures not to exceed 260 °C (500 °F). All (c) Specifications. (1) Poly(p- items are scoured prior to use by agita- methylstyrene) basic polymers identi- tion in a water bath containing 0.5 fied in paragraph (a)(1) of this section gram/liter of tetrasodium shall contain not more than 1 weight pyrophosphate and 0.5 percent deter- percent of total residual p- gent. The items are agitated at 80 °C methystyrene monomer, as determined (180 °F) for 20 minutes, and then sub- by a gas chromatographic method ti- jected to a cold water rinse. (2) Poly(phenyleneterephthalamide) tled, ‘‘Gas Chromatographic Deter- resins in the form of pulp may be used mination of PMS and PET in PPMS as gaskets and packing for food proc- Basic Polymers,’’ which is incorporated essing equipment at temperatures not by reference. Copies are available from to exceed 260 °C (500 °F). the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug [57 FR 3125, Jan. 28, 1992] Administration, 5100 Paint Branch § 177.1635 Poly(p-methylstyrene) and Pkwy., College Park, MD 20740, or rubber-modified poly(p-methyl- available for inspection at the Office of styrene). the Federal Register, 800 North Capitol Poly(p-methylstyrene) and rubber- Street, NW., suite 700, Washington, DC modified poly(p-methylstyrene) identi- 20408. fied in this section may be safely used (2) Rubber-modified poly(p- as components of articles intended for methylstyrene) basic polymers identi- use in contact with food, subject to the fied in paragraph (a)(2) of this section provisions of this section: shall contain not more than 0.5 weight (a) Identity. For the purposes of this percent of total residual p- section, poly(p-methylstyrene) and methylstyrene monomer, as deter- rubber-modified poly(p-methylstyrene) mined by the method identified in are basic polymers, manufactured as paragraph (c)(1) of this section described in this paragraph, meeting (d) Other specifications and limitations. the specifications prescribed in para- The poly(p-methylstyrene) and rubber- graph (c) of this section. modified poly(p-methylstyrene) identi- (1) Poly(p-methylstyrene) (CAS Reg. fied in and complying with this sec- No. 24936–41–2) polymer produced by the polymerization of p-methylstyrene. tion, when used as components of the (2) Rubber-modified poly(p- food-contact surface of any article that methylstyrene) (CAS Reg. No. 33520–88– is the subject of a regulation in parts 6) polymer produced by combining sty- 175, 176, 177, 178 and § 179.45 of this chap- rene-butadiene copolymer and/or ter, shall comply with any specifica- polybutadiene with poly(p- tions and limitations prescribed by methylstyrene), either during or after such regulation for the article in the polymerization of the poly(p- finished form in which it is to contact methylstyrene), such that the finished food. polymers contain not less than 75 (e) Conditions of use. Poly(p- weight percent of total polymer units methylstyrene) basic polymers and derived from p-methylstyrene) mon- rubber-modified poly(p-methylstyrene) omer. basic polymers identified in paragraphs (b) Optional adjuvants. The basic (a)(1) and (a)(2), respectively, of this polymers identified in paragraph (a) of section shall be used in contact with this section may contain optional adju- food only under conditions of use B vant substances required in the produc- through H set forth in table 2 of tion of such basic polymers. Such op- § 176.170(c) of this chapter. tional adjuvant substances may include substances permitted for such [48 FR 31384, July 8, 1983, as amended at 54 use by applicable regulations in this FR 24898, June 12, 1989; 55 FR 52989, Dec. 26, chapter, substances generally recog- 1990] nized as safe in food, substances gen-

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§ 177.1637 Poly(oxy-1,2- (d) Conditions of use. The finished ethanediyloxycarbonyl-2,6- food contact article shall be: naphthalenediylcarbonyl) resins. (1) Used in contact only with food of Poly(oxy-1,2-ethanediyloxycarbonyl- Types I, II, IVB, VIA, VIB, VIIB, and 2,6-naphthalenediylcarbonyl) resins VIII identified in table 1 of § 176.170(c) identified in paragraph (a) of this sec- of this chapter, under conditions of use tion may be safely used as articles or A through H described in table 2 of § 176.170(c) of this chapter; and with components of articles intended for use food of Types III, IVA, V, VIC, VIIA, in contact with food in accordance and IX identified in table 1 of with the following conditions: § 176.170(c) of this chapter, under condi- (a) Identity. For the purpose of this tions of use C through H described in section, poly(oxy-1,2- table 2 of § 176.170(c) of this chapter; ethanediyloxycarbonyl-2,6- and naphthalenediylcarbonyl) resins (CAS (2) Identified in a manner that will Reg. No. 24968–11–4) are polymers differentiate the article from articles formed by catalytic transesterification made of other polymeric resins to fa- of 2,6-dimethylnaphthalene cilitate collection and sorting. dicarboxylate with ethylene glycol followed by catalytic polycondensation. [61 FR 14965, Apr. 4, 1996] (b) Specifications—(1) Density. The § 177.1640 Polystyrene and rubber- density of poly(oxy-1,2- modified polystyrene. ethanediyloxycarbonyl-2,6- Polystyrene and rubber-modified pol- naphthalenediylcarbonyl) resins shall ystyrene identified in this section may be between 1.33 and 1.40 grams per be safely used as components of arti- cubic centimeter. cles intended for use in contact with (2) Inherent viscosity. The finished food, subject to the provisions of this food-contact article shall have a min- section. imum inherent viscosity of 0.55 deci- (a) Identity. For the purposes of this liter per gram in a solution of 0.1 gram section, polystyrene and rubber-modi- of polymer in 100 milliliters of a 25/40/ fied polystyrene are basic polymers 35 (weight/weight/weight) solution of p- manufactured as described in this para- chlorophenol/tetrachloroethane/phenol. graph so as to meet the specifications The viscosity is determined by East- prescribed in paragraph (c) of this sec- man Chemical Co.’s method ECD-A-AC- tion when tested by the method de- G-V-1-5, ‘‘Determination of Dilute So- scribed in paragraph (d) of this section. lution Viscosity of Polyesters,’’ dated (1) Polystyrene consists of basic poly- May 31, 1988, which is incorporated by mers produced by the polymerization reference in accordance with 5 U.S.C. of styrene. 552(a) and 1 CFR part 51. Copies are (2) Rubber-modified polystyrene con- available from the Office of Premarket sists of basic polymers produced by Approval, Center for Food Safety and combining styrene-butadiene copoly- Applied Nutrition (HFS–215), Food and mers and/or polybutadiene with poly- Drug Administration, 5100 Paint styrene, either during or after polym- Branch Pkwy., College Park, MD 20740, erization of the polystyrene, such that or may be examined at the Center for the finished basic polymers contain not Food Safety and Applied Nutrition’s less than 75 weight percent of total Library, Food and Drug Administra- polymer units derived from styrene tion, 5100 Paint Branch Pkwy., College monomer. Park, MD 20740, or at the Office of the (b) Optional adjuvants. The basic Federal Register, 800 North Capitol St. polymers identified in paragraph (a) of NW., Washington, DC. this section may contain optional adju- (c) Extraction limitations. A 0.5 milli- vant substances required in the produc- meter (0.02 inch) thick sheet of resin tion of such basic polymers. Such op- when extracted with water at 121 °C tional adjuvant substances may in- (250 °F) for 2 hours shall yield total clude substances permitted for such nonvolatile extractives not exceeding use by regulations in parts 170 through 2.0 micrograms per square inch of ex- 189 of this chapter, substances gen- posed resin surface. erally recognized as safe in food, and

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substances used in accordance with a pressure and 7 pounds per square inch prior sanction or approval. of hydrogen pressure. (c) Specifications. (1) Polystyrene (iii) The attenuation of the hydrogen basic polymers identified in paragraph flame detector is set at 2×102. (a)(1) of this section shall contain not (6) Standardization. (i) Prepare a more than 1 weight percent of total re- standard solution by weighing accu- sidual styrene monomer, as determined rately 15 to 20 milligrams of styrene by the method described in paragraph monomer into a 2-ounce bottle con- (d) of this section, except that when taining 25.0 milliliters of methylene used in contact with fatty foods of chloride. Cap the bottle tightly and Types III, IV-A, V, VII-A, and IX de- shake to thoroughly mix the solution. scribed in table 1 of § 176.170(c) of this chapter, such polystyrene basic poly- (ii) By means of a microliter syringe, mers shall contain not more than 0.5 inject 1 microliter of the standard solu- weight percent of total residual sty- tion into the gas chromatograph. Meas- rene monomer. ure the area of the styrene monomer (2) Rubber-modified polystyrene peak which emerges after approxi- basic polymers identified in paragraph mately 12 minutes. (a)(2) of this section shall contain not (7) Procedure. (i) Transfer 1 gram of more than 0.5 weight percent of total sample (accurately weighed to the residual styrene monomer, as deter- nearest 0.001 gram to a 2-ounce bottle mined by the method described in para- and add several glass beads. Pipette graph (d) of this section. 25.0 milliliters of methylene chloride (d) Analytical method for determination into the bottle. Cap the bottle tightly of total residual styrene monomer con- and place on a mechanical shaker. tent—(1) Scope. This method is suitable Shake until the polymer is completely for the determination of residual sty- dissolved. If any insoluble residue re- rene monomer in all types of styrene mains, allow the bottle to stand (or polymers. centrifuge at a low speed) until a clear (2) Principle. The sample is dissolved supernatant layer appears. in methylene chloride. An aliquot of (ii) By means of a microliter syringe, the solution is injected into a gas chro- inject 3 microliters of the clear super- matograph. The amount of styrene monomer present is determined from natant liquid into the gas chro- the area of the resulting peak. matograph. (3) Apparatus—(i) Gas chromatograph. (iii) Measure the area of the resulting Beckman GC-2A gas chromatograph styrene monomer peak. Compare the with hydrogen flame detector or appa- sample peak area with the area pro- ratus of equivalent sensitivity. duced by the standard styrene mon- (ii) Chromatograph column. One-quar- omer solution. Calculation: ter inch outside diameter stainless Percent residual styrene steel tubing (0.028 inch wall thickness), monomer=Milligrams monomer in stand- 4 feet in length, packed with 20 percent ard×peak area of sample/Peak area of mon- polyethylene glycol (20,000 molecular omer standard×sample weight in grams×30 weight) on alkaline treated 60–80 mesh firebrick. (e) Other specifications and limitations. (iii) Recorder. Millivolt range of 0–1, The polystyrene and rubber-modified chart speed of 30 inches per hour. polystyrene identified in and com- (4) Reagents. Compressed air, purified; plying with this section, when used as helium gas; hydrogen gas; methylene components of the food-contact surface chloride, redistilled; and styrene mon- of any article that is the subject of a omer, redistilled. regulation in parts 174, 175, 176, 177, 178 (5) Operating conditions for the gas and § 179.45 of this chapter, shall com- chromatograph. (i) The column is oper- ply with any specifications and limita- ated at a temperature of 100 °C with a tions prescribed by such regulation for helium flow rate of 82 milliliters per the article in the finished form in minute. which it is to contact food. (ii) The hydrogen burner is operated with 15 pounds per square inch of air

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(f) Nonapplicability. The provisions of List of substances Limitations this section are not applicable to polystyrene and rubber-modified poly- Xylene ...... Solvent. styrene used in food-packaging adhe- (b) The resins are used as the food- sives complying with § 175.105 of this contact surface for dry food. chapter. (c) An appropriate sample of the fin- § 177.1650 Polysulfide polymer- ished resin in the form in which it con- polyepoxy resins. tacts food, when subjected to ASTM method D968–81, ‘‘Standard Test Meth- Polysulfide polymer-polyepoxy res- ods for Abrasion Resistance of Organic ins may be safely used as the food-con- Coatings by the Falling Abrasive Test- tact surface of articles intended for er,’’ which is incorporated by reference packaging, transporting, holding, or (copies may be obtained from the otherwise contacting dry food, in ac- American Society for Testing Mate- cordance with the following prescribed rials, 1916 Race St., Philadelphia, PA conditions: 19103, or may be examined at the Office (a) Polysulfide polymer-polyepoxy of the Federal Register, 800 North Cap- resins are the reaction products of liq- itol Street, NW., suite 700, Washington, uid polysulfide polymers and DC 20408), using No. 50 Emery abrasive polyfunctional epoxide resins, cured in lieu of Ottawa sand, shall exhibit with the aid of and abrasion coefficient of not less tri(dimethylaminomethyl) phenol, to than 20 liters per mil of film thickness. which have been added certain optional substances to impart desired techno- [42 FR 14572, Mar. 15, 1977, as amended at 49 logical properties to the resins. Subject FR 10110, Mar. 19, 1984] to any limitations prescribed in this section, the optional substances may § 177.1655 Polysulfone resins. include: Polysulfone resins identified in para- (1) Substances generally recognized graph (a) of this section may be safely as safe in food and food packaging. used as articles or components of arti- (2) Substances the use of which is cles intended for use in contact with permitted under applicable regulations food, in accordance with the following in this part, prior sanctions, or approv- prescribed conditions: als. (a) For the purpose of this section, (3) Substances named in this subpara- polysulfone resins are: graph and further identified as re- (1) Poly(oxy-p-phenylenesulfonyl-p- quired: phenyleneoxy-p- phenyleneisopropylidene-p-phenylene) List of substances Limitations resins (CAS Reg. No. 25154–01–2) con- Bis(2-chloroethyl) formal. sisting of basic resins produced when Bis(dichloropropyl) formal ...... Cross-linking agent. the disodium salt of 4,4′- Butyl alcohol ...... Solvent. Carbon black (channel process). isopropylidenediphenol is made to Chlorinated paraffins ...... Cross-linking agent. react with 4,4′-dichlorodiphenyl sulfone Epoxidized linseed oil. in such a way that the finished resins Epoxidized soybean oil. Epoxy resins (as listed in have a minimum number average mo- § 175.300(b)(3)(viii)(a) of this chap- lecular weight of 15,000, as determined ter).. by osmotic pressure in Ethylene glycol monobutyl ether ...... Solvent. Magnesium chloride. monochlorobenzene; or Methyl isobutyl ketone ...... Solvent. (2) 1,1′-Sulfonylbis[4-chlorobenzene] Naphthalene sulfonic acid-formalde- polymer with 4,4′-(1- hyde condensate, sodium salt. Sodium dibutyl naphthalene Wetting agent. methylethylidene)bis[phenol] (min- sulfonate. imum 92 percent) and 4,4′- Sodium hydrosulfide. sulfonylbis[phenol] (maximum 8 per- Sodium polysulfide. cent) (CAS Reg. No. 88285–91–0) pro- b,b′,g,g′-Tetrachloro normal propyl Cross-linking agent. ether. duced when a mixture of 4,4′- Titanium dioxide. isopropylidenediphenol (minimum 92 Toluene ...... Solvent. percent) and 4,4′-sulfonylbis[phenol] Trichloroethane ...... Cross-linking agent. 1,2,3-Trichloropropane ...... Do. (maximum 8 percent) is made to react Urea-formaldehyde resins. with 4,4′-dichlorodiphenyl sulfone in

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such a way that the finished resin has articles or components of articles in- a minimum number average molecular tended to contact food, in accordance weight of 26,000, as determined by os- with the following prescribed condi- motic pressure in dimethylformamide. tions: (b) The basic polysulfone resins iden- (a) Identity. For the purpose of this tified in paragraph (a) of this section section, poly (tetramethylene may contain optional adjuvant sub- terephthalate) is the reaction product stances required in the production of of dimethyl terephthalate with 1,4- such basic resins. The optional adju- butanediol to which may have been vant substances required in the produc- added certain optional substances to tion of the basic polysulfone resins impart desired technological properties may include substances described in to the polymer. § 174.5(d) of this chapter and the fol- (b) Optional adjuvant substances. lowing: Poly(tetramethylene terephthalate) identified in paragraph (a) of this sec- List of substances Limitations tion may contain optional adjuvant Dimethyl sulfoxide ..... Not to exceed 50 parts per million as substances. The quantity of any op- residual solvent in finished basic tional adjuvant substance employed in resin in paragraph (a)(1) of this the production of the polymer does not section. Monochlorobenzene .. Not to exceed 500 parts per million exceed the amount reasonably required as residual solvent in finished to accomplish the intended technical basic resin in paragraph (a)(1) of or physical effect. Such adjuvants may this section. include substances generally recog- N-methyl-2- Not to exceed 0.01 percent (100 pyrrolidone. parts per million) as residual sol- nized as safe in food, substances used in vent in finished basic resin in para- accordance with prior sanction, and graph (a)(2) of this section. substances permitted under applicable regulations in this part. (c) Polysulfone resins, when ex- (c) Specifications. (1) Inherent vis- tracted at reflux temperatures for 6 cosity of a 0.50 percent solution of the hours with the solvents—distilled polymer in phenol/tetrachloroethane water, 50 percent (by volume) ethyl al- (60/40 weight ratio) solvent is not less cohol in distilled water, 3 percent ace- than 0.6 as determined using a Wagner tic acid in distilled water, and n- viscometer (or equivalent) and cal- heptane, yield total extractives in each culated from the following equation: extracting solvent not to exceed 0.0078 milligram per square centimeter (0.05 (natural log arithm of N ) Inherent = r milligram per square inch) of resin sur- viscos ity face. Note: In testing the finished (c) polysulfone resins, use a separate resin where: test sample for each required extract- Nr=Ratio of flow time of the polymer solu- ing solvent. tion to that of the solvent and c=polymer (d) Polysulfone resins intended for re- concentration of the test solution in grams peated use in contact with food may be per 100 milliliters. used under conditions of use A through (2) Poly(tetramethylene H in table 2 of § 176.170(c) of this chap- terephthalate) in the finished form in ter. The resins intended for single-serv- which it is to contact food shall yield ice food-contact use may be used only total extractives as follows: under condition of use H described in (i) Not to exceed 0.08 milligram per table 2 of § 176.170(c) of this chapter. square inch of food contact surface [51 FR 882, Jan. 9, 1986; 51 FR 4165, Feb. 3, when extracted for 2 hours at 250 °F 1986; 61 FR 29475, June 11, 1996] with distilled water. (ii) Not to exceed 0.02 milligram per § 177.1660 Poly (tetramethylene square inch of food contact surface terephthalate). when extracted for 2 hours at 150 °F Poly(tetramethylene terephthalate) with n-heptane. (poly (oxytetramethyleneoxyter- (iii) Not to exceed 0.04 milligram per ephthaloyl)) [Chemical Abstracts Serv- square inch of food contact surface ice Registry No. 24968–12–5] identified when extracted for 2 hours at 212 °F in this section may be safely used as with 3 percent aqueous acetic acid.

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(iv) Not to exceed 0.02 milligram per cordance with the following prescribed square inch of food contact surface conditions: when extracted for 2 hours at 65.6 °C (a) For the purpose of this section, (150 °F) with 50 percent ethanol. polyurethane resins are those produced when one or more of the isocyanates [42 FR 14572, Mar. 15, 1977, as amended at 50 FR 20748, May 20, 1985; 52 FR 20069, May 29, listed in paragraph (a)(1) of this section 1987] is made to react with one or more of the substances listed in paragraph § 177.1670 Polyvinyl alcohol film. (a)(2) of this section: Polyvinyl alcohol film may be safely (1) Isocyanates: used in contact with food of the types Bis(isocyanatomethyl) benzene (CAS Reg. identified in § 176.170(c) of this chapter, No. 25854–16–4). table 1, under Types V, VIII, and IX, in Bis(isocyanatomethyl) cyclohexane (CAS accordance with the following pre- Reg. No. 38661–72–2). ′ ′ scribed conditions: 4,4 -Diisocyanato-3,3 -dimethylbiphenyl (bi- tolylene diisocyanate). (a) The polyvinyl alcohol film is pro- Diphenylmethane diisocyanate. duced from polyvinyl alcohol having a Hexamethylene diisocyanate. minimum viscosity of 4 centipoises 3-Isocyanatomethyl - 3,5,5 - trimethylcyclo- when a 4-percent aqueous solution is hexyl isocyanate. tested at 20 °C. 4,4-Methylenebis(cyclohexyl isocyanate). (b) The finished food-contact film for Toluene diisocyanate. use in contact with Food Types V or (2) List of substances: IX, when extracted with the solvent characterizing the type of food and Adipic acid. under the conditions of time and tem- 1,4-Butanediol. perature characterizing its intended 1,3-Butylene glycol. 1,4–Cyclohexane dimethanol (CAS Reg. No. use as determined from tables 1 and 2 105–08–8). of § 176.170(c) of this chapter, yields 2,2-Dimethyl-1,3-propanediol. total extractives not to exceed 0.078 Ethylene glycol. milligram per square centimeter (0.5 1,6–Hexanediol (CAS Reg. No. 629–11–8).a– milligram per square inch) of food-con- Hydro–w–hydroxypoly(oxy–1,4–butanediyl) tact surface when tested by ASTM (CAS Reg. No. 25190–06–1). method F34–76 (Reapproved 1980), a-Hydro-omega-hydroxypoly (oxytetra- ‘‘Standard Test Method for Liquid Ex- methylene). ′ traction of Flexible Barrier Materials,’’ a,a -(Isopropylidenedi-p-phenylene)bis[omega- hydroxypoly (oxypropylene)(3–4 moles)], which is incorporated by reference. average molecular weight 675. Copies may be obtained from the Amer- Maleic anhydride. ican Society for Testing Materials, 1916 Methyl oxirane polymer with oxirane (CAS Race St., Philadelphia, PA 19103, or Reg. No. 9003–11–6). may be examined at the Office of the Methyl oxirane polymer with oxirane, ether Federal Register, 800 North Capitol with 1,2,3–propanetriol (CAS Reg. No. 9082– Street, NW., suite 700, Washington, DC 00–2). ′ ″ ″′ 20408. a,a a ,a -Neopentanetetrayltetrakis [omega- hydroxypoly (oxypropylene) (1–2 moles)], (c) The finished food-contact film average molecular weight 400. shall not be used as a component of Pentaerythritol-linseed oil alcoholysis prod- food containers intended for use in con- uct. tact with water. Phthalic anhydride. Polybutylene glycol. [42 FR 14572, Mar. 15, 1977, as amended at 49 Polyethyleneadipate modified with ethanol- FR 10110, Mar. 19, 1984] amine with the molar ratio of the amine to the adipic acid less than 0.1 to 1. § 177.1680 Polyurethane resins. Poly(oxycarbonylpentamethylene). The polyurethane resins identified in Polyoxypropylene ethers of 4.4′-isopropyl- paragraph (a) of this section may be idenediphenol (containing an average of 2– safely used as the food-contact surface 4 moles of propylene oxide). Polypropylene glycol. of articles intended for use in contact a,a′,a″-1,2,3-Propanetriyltris [omega- with bulk quantities of dry food of the hydroxypoly (oxypropylene) (15–18 moles)], type identified in § 176.170(c) of this average molecular weight 3,000. chapter, table 1, under Type VIII, in ac- Propylene glycol.

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a,a′,a″-[Propylidynetris (methylene)] tris (b) Optional adjuvant substances em- [omega-hydroxypoly (oxypropylene) (min- ployed in the production of the poly- imum 1.5 moles)], minimum molecular urethane resins or added thereto to im- weight 400. a-[r(1,1,3,3-Tetramethylbutyl) - phenyl]- part desired technical or physical prop- omega-hydroxypoly(oxyethylene) (5 moles), erties may include the following sub- average molecular weight 425. stances: Trimethylol propane.

List of substances Limitations

1-[(2-Aminoethyl)amino]2-propanol ...... As a curing agent. 1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride ...... As a preservative. Colorants used in accordance with § 178.3297 of this chapter.. Dibutyltin diacetate ...... As a catalyst. Dibutyltin dichloride ...... Do. Dibutyltin dilaurate ...... Do. N,N-Dimethyldodecylamine ...... Do. N-Dodecylmorpholine ...... Do. a,a′-[Isopropylidenebis[p-phenyleneoxy(2-hydroxytrimethylene) As a stabilizer. ]]bis[omega-hydroxypoly-(oxyethylene) (136–170 moles)], average molecular weight 15,000. 4,4′-Methylenedianiline ...... As a curing agent. 1,1′,1″-Nitrilotri-2-propanol ...... Do. 2,2′-(p-Phenylenedioxy) diethanol ...... Do. Polyvinyl isobutyl ether. Polyvinyl methyl ether. Soyaalkyd resin ...... Conforming in composition with § 175.300 of this chapter and containing litharge not to exceed that residual from its use as the reaction catalyst and creosol not to exceed that required as an antioxidant. Tetrakis [methylene–(2,5–di-tert-butyl-4-hydroxyhydrocinna- Stabilizer. mate)]methane (CAS Reg. No. 6683–19–8). N,N,N′N′-Tetrakis (2-hydroxypropyl)ethylenediamine ...... As a curing agent. Triethanolamine ...... Do. Trimethyleneglycol di (p-aminobenzoate) (CAS Reg. No. As a curing agent. 57609–64–0).

(c) An appropriate sample of the fin- components of articles intended for use ished resin in the form in which it con- in contact with food, subject to provi- tacts food, when subjected to ASTM sions of this section. method D968–81, ‘‘Standard Test Meth- (a) For the purpose of this section, ods for Abrasion Resistance of Organic styrene block polymers are basic poly- Coatings by the Falling Abrasive Test- mers manufactured as described in this er,’’ which is incorporated by reference paragraph, so that the finished poly- (copies may be obtained from the mers meet the specifications prescribed American Society for Testing Mate- in paragraph (b) of this section, when rials, 1916 Race St., Philadelphia, PA tested by the methods described in 19103, or may be examined at the Office paragraph (c) of this section. of the Federal Register, 800 North Cap- (1) Styrene block polymers with 1,3- itol Street, NW., suite 700, Washington, butadiene are those produced by the DC 20408), using No. 50 Emery abrasive catalytic solution polymerization of in lieu of Ottawa sand, shall exhibit an styrene and 1,3-butadiene. abrasion coefficient of not less than 20 (2) Styrene block polymers with 2- liters per mil of film thickness. methyl-1,3-butadiene are those pro- [42 FR 14572, Mar. 15, 1977, as amended at 46 duced by the catalytic solution polym- FR 57033, Nov. 20, 1981; 49 FR 10110, Mar. 19, erization of styrene and 2-methyl-1,3- 1984; 50 FR 51847, Dec. 20, 1985; 56 FR 15278, butadiene. Apr. 16, 1991; 56 FR 42933, Aug. 30, 1991] (3) Styrene block polymers with 1,3- butadiene, hydrogenated are those pro- § 177.1810 Styrene block polymers. duced by the catalytic solution polym- The styrene block polymers identi- erization of styrene and 1,3-butadiene, fied in paragraph (a) of this section and subsequently hydrogenated. may be safely used as articles or as (b) Specifications:

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Maximum extract- Maximum extractable fraction in dis- able fraction in 50 Molecular Glass transi- tilled water at spec- percent ethanol at Styrene block polymers weight Solubility tion points ified temperatures, specified tempera- (minimum) times, and tures, times, and thicknesses thicknesses

1. (i) Styrene block polymers with 1,3- 29,000 Completely ¥98 °C 0.0039 mg/cm2 0.002 mg/cm2 (0.01 butadiene; for use as articles or as soluble in (¥144 °F) (0.025 mg/in2) of mg/in2) of sur- components of articles that contact toluene. to ¥71 °C surface at reflux face at 66 °C food of Types I, II, IV–B, VI, VII–B, (¥96 °F) temperature for (150 °F) for 2 hr and VIII identified in table 1 in and 86 °C 30 min on a 0.19 on a 0.19 cm § 176.170(c) of this chapter under (187 °F) to cm (0.075 in) (0.075 in) thick conditions of use D, E, F, and G de- 122 °C thick sample. sample. scribed in table 2 in § 176.170(c) of (252 °F). this chapter. (ii) Styrene block polymers with 1,3-bu- 29,000 ...... do ...... do ...... do ...... Do. tadiene; for use as components of pressure-sensitive adhesives that contact food of Types I, II, IV–B, VI, VII–B, and VIII identified in table 1 in § 176.170(c) of this chapter under conditions of use C, D, E, F and G described in table 2 in § 176.170(c) of this chapter, provided the pressure- sensitive adhesives be applied only to closure tapes for sealing containers having a capacity of not less than 160 cc (5.5 fluid ounces) and that the area of the adhesive exposed to food shall not exceed 4.03 cm2 (0.625 in2). The pressure-sensitive adhesive may contain terpene resins as identified in § 175.125(b)(2) of this chapter. 2. Styrene block polymers with 2-meth- 29,000 ...... do ...... ¥65 °C 0.002 mg/cm2 (0.01 0.002 mg/cm2 (0.01 yl-1,3-butadiene; for use as articles (¥85 °F) mg/in2) of sur- mg/in2) of sur- or as components of articles that to ¥47 °C face at reflux face at 66 °C contact food of Types I, II, IV–B, VI, (¥53 °F) temperature for 2 (150 °F) for 2 hr VII–B, and VIII identified in table 1 in and 86 °C hr on a 0.071 cm on a 0.071 cm § 176.170(c) of this chapter. (187 °F) to (0.028 in) thick (0.028 in) thick 122 °C sample. (Option- sample. (Option- (252 °F). ally, maximum ally, maximum net residue solu- net residue soluble in chloroform ble in chloroform shall not exceed shall not exceed 0.00020 mg/cm2 0.00040 mg/cm2 (0.0013 mg/in2) (0.0025 mg/in2) of surface.). of surface.) 3. (i) Styrene block polymers with 1,3- 16,000 ...... do ...... ¥50 °C 0.002 mg/cm2 (0.01 0.002 mg/cm2 (0.01 butadiene, hydrogenated (CAS Reg. (¥58 °F) mg/in2) of sur- mg/in2) of sur- No. 66070–58–4): for use as articles to ¥30 °C face at reflux face at 66 °C or as components of articles that (¥22 °F) temperature for 2 (150 °F) for 2 hr contact food of Types I, II, IV–B, VI, and 92 °C hr on a 0.071 cm on a 0.071 cm VII–B, and VIII identified in table 1 in (198 °F) to (0.028 in) thick (0.028 in) thick § 176.170(c) of this chapter. 98 °C (208 sample. sample. °F). (ii) Styrene block polymers with 1,3-bu- 16,000 ...... do ...... do ...... do ...... Do. tadiene, hydrogenated (CAS Reg. No. 66070–58–4): for use at levels not to exceed 42.4 percent by weight as a component of closures with sealing gaskets that would contact food of Types III, IV–A, V, VII–A, VIII, and IX identified in table 1 in § 176.170(c) of this chapter, and in condition of use D as described under table 2 in § 176.170(c) of this chapter.

(c) The analytical methods for deter- scribed in this section are as follows mining whether styrene block poly- and are applicable to the finished polymers conform to the specifications pre- mer.

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(1) Molecular weight. Molecular cured for 30 minutes at 153 °C to accen- weight shall be determined by intrinsic tuate the upper transition point. viscosity (or other suitable method). (3) Maximum extractable fractions in (2) Glass transition points. The glass distilled water and 50 percent ethanol and transition points shall be determined the maximum net residue solubles in chlo- by either of the following methods: roform. The maximum extractable frac- (i) ASTM method D2236–70 (‘‘Stand- tions in distilled water and 50 percent ard Method of Test for Dynamic Me- ethanol, and the maximum net residue chanical Properties of Plastics by solubles in chloroform, shall be deter- Means of Torsional Pendulum,’’ which mined in accordance with § 176.170(d)(3) is incorporated by reference; copies are of this chapter using a sandwich form available from American Society for of the finished copolymer of the speci- Testing and Materials (ASTM), 1916 fied thickness and for the time and Race Street, Philadelphia, PA 19103, or temperature specified in paragraph (b) available for inspection at the Office of of this section. the Federal Register, 800 North Capitol (d) The provisions of this section are Street, NW., suite 700, Washington, DC not applicable to butadiene-styrene co- 20408) modified by using a forced reso- polymers listed in other sections of nant vibration instead of a fixed vibra- this subpart. tion and by using frequencies of 25 to 40 (e) The provisions of this section are cycles per second instead of 0.1 to 10 not applicable to styrene block poly- cycles per second. mers with 1,3-butadiene listed in (ii) Direct reading viscoelastometric § 175.105 of this chapter. method titled ‘‘Direct Reading Viscoelastrometric Method for Deter- [42 FR 14572, Mar. 15, 1977, as amended at 42 mining Glass Transition Points of Sty- FR 43621, Aug. 30, 1977; 47 FR 11844, Mar. 19, rene Block Polymers’’ (which is incor- 1982; 51 FR 16828, May 7, 1986; 54 FR 24898, porated by reference; copies are avail- June 12, 1989; 58 FR 65546, Dec. 15, 1993] able from the Center for Food Safety and Applied Nutrition (HFS–200), Food § 177.1820 Styrene-maleic anhydride copolymers. and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, Styrene-maleic anhydride copoly- or available for inspection at the Office mers identified in paragraph (a) of this of the Federal Register, 800 North Cap- section may be safely used as articles itol Street, NW., suite 700, Washington, or components of articles intended for DC 20408), by which the glass transition use in contact with food, subject to points are determined in the tensile provisions of this section. mode of deformation at a frequency of (a) For the purpose of this section, 35 hertz using a Rheovibron Model styrene-maleic anhydride copolymers DDV–II (or equivalent) Direct Reading are those produced by the polymeriza- Viscoelastometer. Take maxima in the tion of styrene and maleic anhydride so out-of-phase component of the complex that the finished polymers meet the modulus as the glass transition points. specifications prescribed in paragraph For block polymers of low styrene con- (b) of this section, when tested by the tent or for simple block polymers, the methods described in paragraph (c) of polymer may be treated with 0.3 part this section. per hundred dicumyl peroxide and (b) Specifications:

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Maximum extract- Maximum extract- Molecular Residual able fraction in dis- able fraction in n- weight Residual sty- maleic anhy- tilled water at spec- heptane at speci- Styrene-maleic copolymers (minimum rene mon- dride mon- ified temperatures, fied temperatures, number omer omer times, and particle times, and particle average) size size

1. Styrene-maleic anhydride copoly- 70,000 0.3 weight 0.1 weight 0.006 weight per- 0.02 weight percent mers containing not more than 15 pct percent. percent. cent at reflux at 73 °F for 2 hr maleic anhydride units by weight; for temperature for 1 utilizing particles use as articles or as components of hr utilizing par- of a size that will articles that contact food of Types I, ticles of a size pass through a II, III, IV–A, IV–B, V, VI–B (except that will pass U.S. standard carbonated beverages), VII–A, VII–B, through a U.S. sieve No. 10 and VIII, and IX identified in table 1 in standard sieve will be held on a § 176.170(c) of this chapter under No. 10 and will U.S. standard conditions of use B, C, D, E, F, G, be held on a sieve No. 20. and H described in table 2 in U.S. standard § 176.170(c) of this chapter. sieve No. 20. 2. Styrene-maleic anhydride copolymer ...... 0.3 ...... 0.1 ...... 0.015 weight per- 1.0 weight percent modified with butadiene, (CAS Reg. cent at reflux at 23 °C (73 °F) No. 27288–99–9) containing not temperature for 1 for 2 hours uti- more than 15 percent maleic anhy- hour utilizing par- lizing particles of dride units by weight and not more ticles of a size a size that will than 20 percent styrene-butadiene that will pass pass through a and/or butadiene rubber units by through a U.S. U.S. standard weight; for use (except carbonated standard sieve sieve No. 10 and beverage bottles) as articles or as No. 10 and will will be held on a components of articles that contact be held on a U.S. standard food of Types I, II, III, IV–A, IV–B, V, U.S. standard sieve No. 20. VI, VII–A, VII–B, VIII, and IX identi- sieve No. 20. fied in table I in § 176.170(c) of this chapter under conditions of use B, C, D, E, F, G, and H described in table 2 in § 176.170(c) of this chapter.

(c) The analytical methods for deter- dride copolymers listed in other sec- mining conformance with specifications of this subpart. tions for styrene-maleic anhydride copolymers prescribed in this section are [42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11844, Mar. 19, 1982; 47 FR 14698, Apr. 6, as follows: 1982; 54 FR 24898, June 12, 1989] (1) Molecular weight. Molecular weight shall be determined by mem- § 177.1830 Styrene-methyl methacry- brane osmometry. late copolymers. (2) Residual styrene monomer content. Residual styrene monomer content Styrene-methyl methacrylate co- shall be determined by the method de- polymers identified in this section may scribed in § 177.1640(d). be safely used as components of plastic (3) Residual maleic anhydride monomer articles intended for use in contact content. Residual maleic anhydride with food, subject to the provisions of monomer content shall be determined this section. by a gas chromatographic method ti- (a) For the purpose of this section, tled ‘‘Determination of Residual Ma- styrene-methyl methacrylate copoly- leic Anhydride in Polymers by Gas mers consist of basic copolymers pro- Chromatography,’’ which is incor- duced by the copolymerization of sty- porated by reference. Copies are avail- rene and methyl methacrylate such able from the Center for Food Safety that the finished basic copolymers con- and Applied Nutrition (HFS–200), Food tain more than 50 weight percent of and Drug Administration, 5100 Paint polymer units derived from styrene. Branch Pkwy., College Park, MD 20740, (b) The finished plastic food-contact or available for inspection at the Office article, when extracted with the sol- of the Federal Register, 800 North Cap- vent or solvents characterizing the itol Street, NW., suite 700, Washington, type of food and under the conditions DC 20408. of time and temperature characterizing (d) The provisions of this section are the conditions of intended use as deter- not applicable to styrene-maleic anhy- mined from tables 1 and 2 of § 176.170(c)

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of this chapter, yields extractives not this section are used as prescribed in to exceed the following when tested by paragraph (d)(2) of this section. the methods prescribed in § 177.1010(c); (1) Conditions of test. Textryls, when (1) Total nonvolatile extractives not extracted with distilled water at reflux to exceed 0.3 milligram per square inch temperature for 1 hour, yield total ex- of surface tested. tractives not to exceed 1 percent. (2) Potassium permanganate oxidiz- (2) Uses. Textryls are used for pack- able distilled water and 8 and 50 per- aging or holding food at ordinary tem- cent alcohol extractives not to exceed peratures and in the brewing of hot an absorbance of 0.15. beverages. (3) Ultraviolet-absorbing distilled water and 8 and 50 percent alcohol ex- § 177.1900 Urea-formaldehyde resins in tractives not to exceed an absorbance molded articles. of 0.30. Urea-formaldehyde resins may be (4) Ultraviolet-absorbing n-heptane safely used as the food-contact surface extractives not to exceed an absorb- of molded articles intended for use in ance of 0.40. contact with food, in accordance with the following prescribed conditions: § 177.1850 Textryls. (a) For the purpose of this section, Textryls identified in this section urea-formaldehyde resins are those may be safely used as articles or com- produced when 1 mole of urea is made ponents of articles, intended for use in to react with not more than 2 moles of producing, manufacturing, packing, formaldehyde in water solution. processing, preparing, treating, pack- (b) The resins may be mixed with re- aging, transporting or holding food, fined wood pulp and the mixture may subject to the provisions of this sec- contain other optional adjuvant sub- tion. stances which may include the fol- (a) Textryls are nonwoven sheets pre- lowing: pared from natural or synthetic fibers, bonded with fibryl (Fibryl consists of a List of substances Limitations polymeric resin in fibrous form com- Hexamethylenetetramine ...... For use only as polymeriza- mingled with fiber to facilitate sheet tion-control agent. formation and subsequently heat cured Tetrachlorophthalic acid an- Do. to fuse the fibryl and effect bonding). hydride. (b) Textryls are prepared from the fi- Zinc stearate ...... For use as lubricant. bers, fibryls, and adjuvants identified (c) The finished food-contact article, in paragraph (c) of this section, and when extracted with the solvent or sol- subject to limitations prescribed in vents characterizing the type of food that paragraph, provided that any sub- and under the conditions of time and stance that is the subject of a regula- temperature characterizing the condition in parts 174, 175, 176, 177, 178 and tions of its intended use as determined § 179.45 of this chapter conforms with from tables 1 and 2 of § 175.300(d) of this any specifications in such regulation chapter, yields total extractives in for that substance as a component of each extracting solvent not to exceed polymeric resins used as food contact 0.5 milligram per square inch of food- surfaces. contact surface as determined by the (c) The fibers, fibryls, and adjuvants methods described in § 175.300(e) of this permitted are as follows: chapter. Substances Limitations NOTE: In testing the finished food-contact article, use a separate test sample for each (1) Fibers prepared from pol- Conforming with § 177.1630. required extracting solvent. yethylene terephthalate resins. (2) Fibryls prepared from As the basic polymer. § 177.1950 Vinyl chloride-ethylene co- vinyl chloride-vinyl acetate polymers. copolymer. (3) Adjuvant substance, As a solvent in the prepara- The vinyl chloride-ethylene copoly- dimethylformamide. tion of fibryl. mers identified in paragraph (a) of this section may be safely used as compo- (d) Textryls meeting the conditions nents of articles intended for contact of test prescribed in paragraph (d)(1) of with food, under conditions of use D, E,

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F, or G described in table 2 of § 176.170 (iii) Total extractives obtained by ex- (c) of this chapter, subject to the provi- tracting with water at 150 °F for 2 sions of this section. hours contain no more than 0.5 milli- (a) For the purpose of this section, gram of vinyl chloride-ethylene copol- vinyl chloride-ethylene copolymers ymer per 100 grams of sample tested as consist of basic copolymers produced determined from the organic chlorine by the copolymerization of vinyl chlo- content. The organic chlorine content ride and ethylene such that the fin- is determined as described in paragraph ished basic copolymers meet the speci- (d)(3) of this section. fications and extractives limitations (d) Analytical methods: The analyt- prescribed in paragraph (c) of this sec- ical methods for determining whether tion, when tested by the methods de- vinyl chloride-ethylene basic copoly- scribed in paragraph (d) of this section. mers conform to the extractives limi- (b) The basic vinyl chloride-ethylene tations prescribed in paragraph (c) of copolymers identified in paragraph (a) this section are as follows and are ap- of this section may contain optional plicable to the basic copolymers in adjuvant substances required in the powder form having a particle size such production of such basic copolymers. that 100 percent will pass through a The optional adjuvant substances re- U.S. Standard Sieve No. 40 and 80 per- quired in the production of the basic cent will pass through a U.S. Standard vinyl chloride-ethylene copolymers Sieve No. 80: may include substances permitted for (1) Reagents—(i) Water. All water used such use by regulations in parts 170 in these procedures shall be through 189 of this chapter, substances demineralized (deionized), freshly dis- generally recognized as safe in food, tilled water. and substances used in accordance with a prior sanction or approval. (ii) n-Heptane. Reagent grade, freshly (c) The vinyl chloride-ethylene basic distilled n-heptane shall be used. copolymers meet the following speci- (2) Determination of total amount of ex- fications and extractives limitations: tractives. All determinations shall be (1) Specifications. (i) Total chlorine done in duplicate using duplicate content is in the range of 53 to 56 per- blanks. Approximately 400 grams of cent as determined by any suitable an- sample (accurately weighed) shall be alytical procedure of generally accept- placed in a 2-liter Erlenmeyer flask. ed applicability. Add 1,200 milliliters of solvent and (ii) Intrinsic viscosity in cover the flask with aluminum foil. cyclohexanone at 30 °C is not less than The covered flask and contents are sus- 0.50 deciliter per gram as determined pended in a thermostated bath and are by ASTM method D1243–79, ‘‘Standard kept, with continual shaking at 150 °F Test Method for Dilute Solution Vis- for 2 hours. The solution is then fil- cosity of Vinyl Chloride Polymers,’’ tered through a No. 42 Whatman filter which is incorporated by reference. paper, and the filtrate is collected in a Copies may be obtained from the Amer- graduated cylinder. The total amount ican Society for Testing Materials, 1916 of filtrate (without washing) is meas- Race St., Philadelphia, PA 19103, or ured and called A milliliters. The fil- may be examined at the Office of the trate is transferred to a Pyrex (or Federal Register, 800 North Capitol equivalent) beaker and evaporated on a Street, NW., suite 700, Washington, DC steam bath under a stream of nitrogen 20408. to a small volume (approximately 50–60 (2) Extractives limitations. The fol- milliliters). The concentrated filtrate lowing extractives limitations are de- is then quantitatively transferred to a termined by the methods described in tared 100-milliliter Pyrex beaker using paragraph (d) of this section: small, fresh portions of solvent and a (i) Total extractives do not exceed rubber policeman to effect the transfer. 0.10 weight-percent when extracted The concentrated filtrate is evaporated with n-heptane at 150 °F for 2 hours. almost to dryness on a hotplate under (ii) Total extractives do not exceed nitrogen, and is then transferred to a 0.03 weight-percent when extracted drying oven at 230 °F in the case of the with water at 150 °F for 2 hours. aqueous extract or to a vacuum oven at

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150 °F in the case of the heptane extract, it is overnight under vacuum at tract. In the case of the aqueous ex- 150 °F. The residue is weighed and cor- tract, the evaporation to constant rected for the solvent blank. Calcula- weight is completed in 15 minutes at tion: 230 °F; and in the case of heptane ex-

Gramsof corrected residue 1, 200 milliliters Total extractives expressed as ××=100 Grams of sample Volume of filtrate percent by weight of sample. A in milliliters

(3) Vinyl chloride-ethylene copolymer evaporated carefully on a steam plate content of aqueous extract—(i) Principle. to a volume of approximately 50 milli- The vinyl chloride-ethylene copolymer liters and then transferred quan- content of the aqueous extract can be titatively, a little at a time, to a clean determined by determining the organic 22-milliliter Parr cup, also on the chlorine content and calculating the steam plate. The solution is evaporated amount of copolymer equivalent to the to dryness. Next 0.25 gram of sucrose organic chlorine content. and 0.5 gram of benzoic acid are added (ii) Total organic chlorine content. A to the cup. One scoop (approximately weighed sample of approximately 400 15 grams) of sodium peroxide is then grams is extracted with 1,200 milliliters added to the cup. The bomb is assem- of water at 150 °F for 2 hours, filtered, bled and ignition is conducted in the and the volume of filtrate is measured usual fashion. (A milliliters) as described in para- (d) After the bomb has cooled, it is graph (d)(2) of this section. rinsed thoroughly with distilled water (a) A slurry of Amberlite IRA–400, or and disassembled. The top of the bomb equivalent, is made with distilled is rinsed into a 250-milliliter beaker water in a 150-milliliter beaker. The with distilled water. The beaker is slurry is added to a chromatographic placed on the steam plate. The bomb column until it is filled to about half cup is placed in the beaker and care- its length. This should give a volume of resin of 15–25 milliliters. The liquid fully tipped over to allow the water to must not be allowed to drain below the leach out the combustion mixture. top of the packed column. After the bubbling has stopped, the cup (b) The column is regenerated to the is removed from the beaker and rinsed basic (OH) form by slowly passing thoroughly. The solution is cooled to through it (10–15 milliliters per minute) room temperature and cautiously neu- 10 grams of sodium hydroxide dissolved tralized with concentrated nitric acid in 200 milliliters of water. The column by slowly pouring the acid down a stir- is washed with distilled water until the ring rod until the bubbling ceases. The effluent is neutral to phenolphthalein. solution is cooled and an equal volume One drop of methyl red indicator is of acetone is added. added to the A milliliters of filtered (e) The solution is titrated with 0.005 aqueous extract and, if on the basic N silver nitrate using standard poten- side (yellow), nitric acid is added drop tiometric titration techniques with a by drop until the solution turns pink. silver electrode as indicator and a po- (c) The extract is deionized by pass- tassium nitrate modified calomel elec- ing it through the exchange column at trode as a reference electrode. An ex- a rate of 10–15 milliliters per minute. panded scale recording titrimeter. The column is washed with 200 milli- Metrohm Potentiograph 2336 or equiva- liters of distilled water. The deionized lent, should be used; a complete blank extract and washings are collected in a must be run in duplicate. 1,500-milliliter beaker. The solution is (iii) Calculations.

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Milligrams of aqueous extracted TF××64.3 = ×100 copolymer per 100-gram sample Weight of sample in grams

where: (1) Specifications. (i) Total chlorine T=Milliliters of silver nitrate (sample minus content is 53 to 56 percent as deter- blank)×normality of silver nitrate. mined by any suitable analytical pro- F=1,200/A (as defined above) cedure of generally accepted applica- (e) The vinyl chloride-ethylene co- bility. polymers identified in and complying (ii) Inherent viscosity in ° with this section, when used as compo- cyclohexanone at 30 C is not less than nents of the food-contact surface of 0.59 deciliters per gram as determined any article that is the subject of a reg- by ASTM method D1243–79, ‘‘Standard ulation in parts 174, 175, 176, 177, 178 Test Method for Dilute Solution Vis- and § 179.45 of this chapter, shall com- cosity of Vinyl Chloride Polymers,’’ ply with any specifications and limita- which is incorporated by reference. tions prescribed by such regulation for Copies may be obtained from the Amer- the article in the finished form in ican Society for Testing Materials, 1916 which it is to contact food. Race St., Philadelphia, PA 19103, or (f) The provisions of this section are may be examined at the Office of the not applicable to vinyl chloride-ethyl- Federal Register, 800 North Capitol ene copolymers used as provided in Street, NW., suite 700, Washington, DC §§ 175.105 and 176.180 of this chapter. 20408. (2) Extractives limitations. The fol- [42 FR 14572, Mar. 15, 1977, as amended at 49 lowing extractives limitations are de- FR 10110, Mar. 19, 1984] termined by the methods prescribed in § 177.1970(d). § 177.1960 Vinyl chloride-hexene-1 copolymers. (i) Total extractives do not exceed 0.01 weight percent when extracted The vinyl chloride-hexene-1 copoly- with water at 150 °F for 2 hours. mers identified in paragraph (a) of this (ii) Total extractives do not exceed section or as components of articles in- 0.30 weight percent when extracted tended for use in contact with food, with n-heptane at 150 °F for 2 hours. under conditions of use D, E, F, or G (c) Other specifications and limitations. described in table 2 of § 176.170(c) of this The vinyl chloride-hexene-1 copoly- chapter, subject to the provisions of mers identified in and complying with this section. this section, when used as components (a) Identity. For the purposes of this of the food-contact surface of any arti- section vinyl chloride-hexene-1 copoly- cle that is subject to a regulation in mers consist of basic copolymers pro- parts 174, 175, 176, 177, 178 and § 179.45 of duced by the copolymerization of vinyl this chapter, shall comply with any chloride and hexene-1 such that the fin- specifications and limitations pre- ished copolymers contain not more scribed by such regulation for the arti- than 3 mole-percent of polymer units cle in the finished form in which it is derived from hexene-1 and meet the to contact food. specifications and extractives limitations prescribed in paragraph (b) of this [42 FR 14572, Mar. 15, 1977, as amended at 49 section. The copolymers may option- FR 10110, Mar. 19, 1984] ally contain hydroxypropyl methylcellulose and trichloroethylene used as § 177.1970 Vinyl chloride-lauryl vinyl a suspending agent and chain transfer ether copolymers. agent, respectively, in their produc- The vinyl chloride-lauryl vinyl ether tion. copolymers identified in paragraph (a) (b) Specifications and limitations. The of this section may be used as an arti- vinyl chloride-hexene-1 basic copoly- cle or as a component of an article in- mers meet the following specifications tended for use in contact with food sub- and extractives limitations: ject to the provisions of this section.

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(a) Identity. For the purposes of this (d) Analytical methods. The analytical section vinyl chloride-lauryl vinyl methods for determining total extrac- ether copolymers consist of basic co- tives are applicable to the basic copolymers produced by the copolym- polymers in powder form having a par- erization of vinyl chloride and lauryl ticle size such that 100 percent will vinyl ether such that the finished co- pass through a U.S. Standard Sieve No. polymers contain not more than 3 40 and such that not more than 10 per- weight-percent of polymer units de- cent will pass through a U.S. Standard rived from lauryl vinyl ether and meet Sieve No. 200. the specifications and extractives limi- (1) Reagents—(i) Water. All water used tations prescribed in paragraph (c) of in these procedures shall be this section. demineralized (deionized), freshly dis- (b) Optional adjuvant substances. The tilled water. basic vinyl chloride-lauryl vinyl ether (ii) n-Heptane. Reagent grade, freshly copolymers identified in paragraph (a) distilled n-heptane shall be used. of this section may contain optional (2) Determination of total amount of ex- adjuvant substances required in the tractives. Place an accurately weighed production of such basic copolymers. sample of suitable size in a clean These optional adjuvant substances borosilicate flask, and for each gram of may include substances permitted for sample add 3 milliliters of solvent pre- such use by regulations in parts 170 viously heated to 150 °F. Maintain the through 189 of this chapter, substances temperature of the contents of the generally recognized as safe in food, flask at 150 °F for 2 hours using a hot and substances used in accordance with plate while also maintaining gentle a prior sanction or approval. mechanical agitation. Filter the con- (c) Specifications and limitations. The tents of the flask rapidly through No. vinyl chloride-lauryl vinyl ether basic 42 Whatman filter paper with the aid of copolymers meet the following speci- suction. Transfer the filtrate to flat fications and extractives limitations: glass dishes that are warmed on a hot (1) Specifications. (i) Total chlorine plate and evaporate the solvent with content is 53 to 56 percent as deter- the aid of a stream of filtered air. When mined by any suitable analytical pro- the volume of the filtrate has been re- cedure of generally accepted applica- duced to 10 to 15 milliliters, transfer bility. the filtrate to tared 50-milliliter (ii) Inherent viscosity in borosilicate glass beakers and com- ° cylcoHhexanone at 30 C is not less plete evaporation to a constant weight than 0.60 deciliter per gram as deter- in a 140 °F vacuum oven. Carry out a mined by ASTM method D1243–79, corresponding blank determination ‘‘Standard Test Method for Dilute So- with each solvent. Determine the lution Viscosity of Vinyl Chloride weight of the residue corrected for the Polymers,’’ which is incorporated by solvent blank and calculate the result reference. Copies may be obtained from as percent of the initial weight of the the American Society for Testing Ma- resin sample taken for analysis. terials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office (e) Other specifications and limitations. of the Federal Register, 800 North Cap- The vinyl chloride-lauryl vinyl ether itol Street, NW., suite 700, Washington, copolymers identified in and complying DC 20408. with this section, when used as compo- (2) Extractives limitations. The fol- nents of the food-contact surface of lowing extractives limitations are de- any article that is subject to a regula- termined by the method described in tion in parts 174, 175, 176, 177, 178 and paragraph (d) of this section: § 179.45 of this chapter, shall comply (i) Total extractives do not exceed with any specifications and limitations 0.03 weight-percent when extracted prescribed by such regulation for the with water at 150 °F for 2 hours. article in the finished form in which it is to contact food. (ii) Total extractives do not exceed 0.60 weight-percent when extracted [42 FR 14572, Mar. 15, 1977, as amended at 49 with n-heptane at 150 °F for 2 hours. FR 10110, Mar. 19, 1984]

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§ 177.1980 Vinyl chloride-propylene co- (i) Total extractives do not exceed polymers. 0.10 weight-percent when extracted The vinyl chloride-propylene copoly- with n-heptane at 150 °F for 2 hours. mers identified in paragraph (a) of this (ii) Total extractives do not exceed section may be safely used as compo- 0.03 weight-percent when extracted nents of articles intended for contact with water at 150 °F for 2 hours. with food, subject to the provisions of (iii) Total extractives obtained by ex- this section. tracting with water at 150 °F for 2 (a) For the purpose of this section, hours contain no more than 0.17 milli- vinyl chloride-propylene copolymers gram of vinyl chloride-propylene co- consist of basic copolymers produced polymer per 100 grams of sample tested by the copolymezation of vinyl chlo- as determined from the organic chloride and propylene such that the fin- rine content. For the purpose of this ished basic copolymers meet the speci- section, the organic chlorine content is fications and extractives limitations the difference between the total chlo- prescribed in paragraph (c) of this sec- rine and ionic chlorine contents deter- tion, when tested by the methods de- mined as described in paragraph (d) of scribed in paragraph (d) of this section. this section. (b) The basic vinyl chloride-pro- (d) Analytical methods: The analyt- pylene copolymers identified in para- ical methods for determining whether graph (a) of this section may contain vinyl chloride-propylene basic copoly- optional adjuvant substances required mers conform to the extractives limi- in the production of such basic copoly- tations prescribed in paragraph (c) of mers. The optional adjuvant sub- this section are as follows and are ap- stances required in the production of plicable to the basic copolymers in the basic vinyl chloride-propylene co- powder form having a particle size such polymers may include substances per- that 100 percent will pass through a mitted for such use by regulations in U.S. Standard Sieve No. 40 and 80 per- parts 170 through 189 of this chapter, cent will pass through a U.S. Standard substances generally recognized as safe Sieve No. 80: in food, and substances used in accord- (1) Reagents—(i) Water. All water used ance with a prior sanction or approval. in these procedures shall be (c) The vinyl chloride-propylene demineralized (deionized), freshly dis- basic copolymers meet the following tilled water. specifications and extractives limita- (ii) n-Heptane. Reagent grade, freshly tions: distilled n-heptane shall be used. (1) Specifications. (i) Total chlorine (2) Determination of total amount of ex- content is in the range of 53 to 56 per- tractives. All determinations shall be cent as determined by any suitable an- done in duplicate using duplicate alytical procedure of generally accept- blanks. Approximately 400 grams of ed applicability. sample (accurately weighed) shall be (ii) Intrinsic viscosity in cyclo- placed in a 2-liter Erlenmeyer flask. hexanone at 30 °C is not less than 0.50 Add 1,200 milliliters of solvent and deciliter per gram as determined by cover the flask with aluminum foil. ASTM method D1243–79, ‘‘Standard The covered flask and contents are sus- Test Method for Dilute Solution Vis- pended in a thermostated bath and are cosity of Vinyl Chloride Polymers,’’ kept, with continual shaking, at 150 °F which is incorporated by reference. for 2 hours. The solution is then fil- Copies may be obtained from the Amer- tered through a No. 42 Whatman filter ican Society for Testing Materials, 1916 paper, and the filtrate is collected in a Race St., Philadelphia, PA 19103, or graduated cylinder. The total amount may be examined at the Office of the of filtrate (without washing) is meas- Federal Register, 800 North Capitol ured and called A milliliters. The fil- Street, NW., suite 700, Washington, DC trate is transferred to a Pyrex (or 20408. equivalent) beaker and evaporated on a (2) Extractives limitations. The fol- steam bath under a stream of nitrogen lowing extractives limitations are de- to a small volume (approximately 50–60 termined by the methods described in milliliters). The concentrated filtrate paragraph (d) of this section: is then quantitatively transferred to a

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tared 100-milliliter Pyrex beaker using tract. In the case of the aqueous ex- small, fresh portions of solvent and a tract the evaporation to constant rubber policeman to effect the transfer. weight is completed in 15 minutes at The concentrated filtrate is evaporated 230 °F; and in the case of heptane ex- almost to dryness on a hotplate under tract, it is overnight under vacuum at nitrogen, and is then transferred to a 150 °F. The residue is weighed and cor- drying oven at 230 °F in the case of the rected for the solvent blank. Calcula- aqueous extract or to a vacuum oven at tion: 150 °F in the case of the heptane ex-

Gramsof corrected residue 1, 200 milliliters Total extractives expressed as ××=100 Grams of sample Volume of filtrate percent by weight of sample. A in milliliters

(3) Vinyl chloride-propylene copolymer ducted in the usual fashion using a content of aqueous extract—(i) Principle. Meeker burner. The heating is contin- The vinyl chloride-propylene copoly- ued for 1 minute after the water at the mer content of the aqueous extract can top has evaporated. The bomb is be determined by determining the or- quenched in water, rinsed with distilled ganic chlorine content and calculating water, and placed in a 400-milliliter the amount of copolymer equivalent to beaker. The bomb cover is rinsed with the organic chlorine content. The or- water, catching the washings in the ganic chlorine content is the difference same 400-milliliter beaker. The bomb is between the total chlorine content and covered with distilled water and a the ionic chlorine content. watch glass and heated until the melt (ii) Total chlorine content. A weighed has dissolved. The bomb is removed, sample is extracted with water at 150 rinsed, catching the rinsings in the °F for 2 hours, filtered, and the volume beaker, and the solution is acidified of filtrate is measured (A milliliters) as with concentrated nitric acid using described in paragraph (d)(2) of this section. Two drops of 50 percent by methyl purple as an indicator. The weight sodium hydroxide solution are beaker is covered with a watch glass, added to prevent loss of chloride from and the contents are boiled gently for ammonium chloride, if present, and the 10–15 minutes. After cooling to room solution is evaporated to approxi- temperature the solution is made mately 15 milliliters. The concentrated slightly alkaline with 50 percent by filtrate is quantitatively transferred to weight sodium hydroxide solution, a 22-milliliter Parr bomb fusion cup then acidified with dilute (1:5) nitric and gently evaporated to dryness. To acid. Then 1.5 milliliters of 2 N nitric the contents of the cup are added 3.5 acid per 100 milliliters of solution is grams of granular sodium peroxide, 0.1 added and the solution is titrated with gram of powdered starch, and 0.02 gram 0.005 N silver nitrate to the equivalence potassium nitrate; and the contents potential end point using an expanded are mixed thoroughly. The bomb is as- scale pH meter (Beckman Model 76, or sembled, water is added to the recess at equivalent). A complete blank must be the top of the bomb and ignition is con- run in duplicate. Calculation:

Grams of sample 1,200 milliliters Milliequivalents of total chlorine in ××=100 (B− C) Volume of filtrate aqueous extract of 100 grams of sample A in milliliters

where: A=volume of filtrate obtained in extraction.

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B=milliliters of silver nitrate solution used mately 150 milliliters. The solution is in sample titration×normality of silver ni- quantitatively transferred to a 250-mil- trate solution. liliter beaker, methyl purple indicator C=milliliters of silver nitrate solution used in blank titration×normality of silver ni- is added, and the solution is neutral- trate solution. ized with 0.1 N nitric acid. For each 100 milliliters of solution is added 1.5 mil- (iii) Ionic chlorine content. A weighed sample is extracted with water at 150 liliters of 2 N nitric acid. The solution °F for 2 hours, filtered, and the volume is titrated with 0.005 N silver nitrate to of filtrate is measured (A milliliters) as the equivalence potential end point, in paragraph (d)(2) of this section. Two using the expanded scale pH meter de- drops of 50 percent by weight sodium scribed in paragraph (d)(3)(ii) of this hydroxide solution are added and the section. A complete blank must be run solution is evaporated to approxi- in duplicate. Calculation:

DE− 1, 200 milliliters Milliequivalents of ionic chlorine in ××=100 Grams of sample Volume of filtrate aqueousextract of100 gramsof sample. A in milliliters

where: (e) The vinyl chloride-propylene co- A=volume of filtrate obtained in extraction. polymers identified in and complying D=milliliters of silver nitrate solution used with this section, when used as compo- in sample titration×normality of silver ni- nents of the food-contact surface of trate solution. any article that is the subject of a reg- E=milliliters of silver nitrate solution used ulation in parts 174, 175, 176, 177, 178 in blank titration×normality of silver ni- and § 179.45 of this chapter, shall com- trate solution. ply with any specifications and limita- (iv) Organic chlorine content and vinyl tions prescribed by such regulation for chloride-propylene copolymer content of the article in the finished form in which it is to contact food. aqueous extract. The organic chlorine (f) The provisions of this section are content and the vinyl chloride pro- not applicable to vinyl chloride-propylene copolymer content of the aque- pylene copolymers used in food-pack- ous extract is calculated as follows: aging adhesives complying with (a) Organic chlorine content. Milli- § 175.105 of this chapter. equivalents of organic chlorine in aqueous extract of 100 grams of sample [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984] equal milliequivalents of total chlorine in aqueous extract of 100 grams of sam- § 177.1990 Vinylidene chloride/methyl ple (as calculated in paragraph (d)(3)(ii) acrylate copolymers. of this section) minus milliequivalents The vinylidene chloride/methyl acry- of ionic chlorine in aqueous extract of late copolymers (CAS Reg. No. 25038– 100 grams of sample (as calculated in 72–6) identified in paragraph (a) of this paragraph (d)(3)(iii) of this section). section may be safely used as an article (b) Vinyl chloride-propylene copolymer or as a component of an article in- content. Milligrams of vinyl chloride- tended for use in contact with food sub- propylene copolymer in aqueous ex- ject to the provisions of this section. tract of 100 grams of sample equal (a) Identity. For the purposes of this milliequivalents of organic chlorine in section vinylidene chloride/methyl ac- aqueous extract of 100 grams of sample rylate copolymers consist of basic co- (as calculated in paragraph (d)(3)(iv) (a) polymers produced by the copolym- of this section) multiplied by 84.5. erization of vinylidene chloride and NOTE: The conversion factor, 84.5, is de- methyl acrylate such that the copoly- rived from the equivalent weight of chlorine mers contain not more than 15 weight- divided by the chlorine content of the percent of polymer units derived from heptane extractable fraction.) methyl acrylate.

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(b) Optional adjuvant substances. The termination of Residual Vinylidene basic vinylidene chloride/methyl acry- Chloride and Methyl Acrylate in Vinyl- late copolymers identified in paragraph idene Chloride/Methyl Acrylate Co- (a) of this section may contain optional polymer Resins and Films,’’ or, alter- adjuvant substances required in the natively, ‘‘Residual Methyl Acrylate production of such basic copolymers. and Vinylidene Chloride Monomers in These optional adjuvant substances Saran MA/VDC Resins and Pellets by may include substances permitted for Headspace Gas Chromatography,’’ such use by regulations in parts 170 dated March 3, 1986, which are incor- through 179 of this chapter, substances porated by reference in accordance generally recognized as safe in food, with 5 U.S.C. 552(a). Copies are avail- and substances used in accordance with able from the Center for Food Safety a prior sanction or approval. and Applied Nutrition (HFS–200), Food (c) Specifications. (1) The methyl acry- and Drug Administration, 5100 Paint late content is determined by an infra- Branch Pkwy., College Park, MD 20740, red spectrophotometric method titled or available for inspection at the Office ‘‘Determination of Copolymer Ratio in of the Federal Register, 800 North Cap- Vinylidene Chloride/Methyl Acrylate Copolymers,’’ which is incorporated by itol Street, NW., suite 700, Washington, reference. Copies are available from DC 20408. the Center for Food Safety and Applied (d) Extractives limitations. The basic Nutrition (HFS–200), Food and Drug copolymer resin in the form of granules Administration, 5100 Paint Branch that will pass through a U.S. Standard Pkwy., College Park, MD 20740, or Sieve No. 45 (350 microns) shall meet available for inspection at the Office of the following extractives limitations: the Federal Register, 800 North Capitol (1) 10-gram samples of the resin, Street, NW., suite 700, Washington, DC when extracted separately with 100 20408. milliliters of distilled water at 121 °C (2) The weight average molecular (250 °F) for 2 hours, and 100 milliliters weight of the copolymer is not less of n-heptane at 66 °C (150 °F) for 2 than 50,000 when determined by gel per- hours, shall yield total nonvolatile ex- meation chromatography using tetra- tractives not to exceed 0.5 percent by hydrofuran as the solvent. The gel per- weight of the resin. meation chromatograph is calibrated (2) The basic copolymer in the form with polystyrene standards. The basic of film when extracted separately with gel permeation chromatographic meth- distilled water at 121 °C (250 °F) for 2 od is described in ANSI/ASTM D3536–76, hours shall yield total nonvolatile ex- ‘‘Standard Test Method for Molecular tractives not to exceed 0.047 milligram Weight Averages and Molecular Weight per square centimeter (0.3 milligram Distribution of Polystyrene by Liquid per square inch). Exclusion Chromatography (Gel Per- (e) Conditions of use. The copolymers meation Chromatography-GPC),’’ which is incorporated by reference. may be safely used as articles or com- Copies are available from University ponents of articles intended for use in Microfilms International, 300 North producing, manufacturing, processing, Zeeb Rd., Ann Arbor, MI 48106, or avail- preparing, treating, packaging, trans- able for inspection at the Office of the porting, or holding food, including Federal Register, 800 North Capitol processing of packaged food at tem- Street, NW., suite 700, Washington, DC peratures not to exceed 135 °C (275 °F). 20408. (f) Other specifications and limitations. (3) Residual vinylidene chloride and The vinylidene chloride-methyl acry- residual methyl acrylate in the copoly- late copolymers identified in and commer in the form in which it will con- plying with this section, when used as tact food (unsupported film, barrier components of the food contact surface layer, or as a copolymer for blending) of any article that is subject to a regu- will not exceed 10 parts per million and lation in parts 174 through 178 and 5 parts per million, respectively, as de- § 179.45 of this chapter, shall comply termined by either a gas with any specifications and limitations chromatographic method titled ‘‘De- prescribed by such regulation for the

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article in the finished form in which it rived from methyl acrylate monomer is to contact food. and not more than 6 weight percent of polymer units derived from methyl [48 FR 38605, Aug. 25, 1983; 48 FR 50077, Oct. 31, 1983, as amended at 53 FR 47185, Nov. 22, methacrylate monomer. 1988; 54 FR 24898, June 12, 1989] (ii) The basic polymers are limited to a thickness of not more than 0.005 cen- § 177.2000 Vinylidene chloride/methyl timeter (0.002 inches). acrylate/methyl methacrylate poly- (2) The weight average molecular mers. weight of the basic polymer is not less The vinylidene chloride/methyl acry- than 100,000 when determined by gel late/methyl methacrylate polymers permeation chromatography using tet- (CAS Reg. No. 34364–83–5) identified in rahydrofuran as the solvent. The gel paragraph (a) of this section may be permeation chromatography is cali- safely used as articles or as a compo- brated with polystyrene standards. The nent of articles intended for use in con- basic gel permeation chromatographic tact with food subject to the provisions method is described in ANSI/ASTM of this section. D3536–76, which is incorporated by ref- (a) Identity. For the purpose of this erence. Copies are available from the section, vinylidene chloride/methyl ac- American Society for Testing Mate- rylate/methyl methacrylate polymers rials, 1916 Race St., Philadelphia, PA consist of basic polymers produced by 19103, or available for inspection at the the copolymerization of vinylidene Office of the Federal Register, 800 chloride/methyl acrylate/methyl meth- North Capitol Street, NW., suite 700, acrylate such that the basic polymers Washington, DC 20408. or the finished food-contact articles (3) The basic polymer or food-contact meet the specifications prescribed in article described in paragraph (a) of paragraph (d) of this section. this section, when extracted with the (b) Optional adjuvant substances. The solvent or solvents characterizing the basic vinylidene chloride/methyl acry- type of food and under the conditions late/methyl methacrylate polymers of time and temperature characterizing identified in paragraph (a) of this sec- the conditions of its intended use as de- tion may contain optional adjuvant termined from tables 1 and 2 of substances required in the production § 176.170(c) of this chapter, yields net of such basic polymers. These optional chloroform-soluble extractives in each adjuvant substances may include sub- extracting solvent not to exceed .08 stances permitted for such use by regu- milligram per square centimeter (0.5 lations in parts 170 through 179 of this milligram per square inch) of food-con- chapter, substances generally recog- tact surface when tested by the meth- nized as safe in food, and substances ods described in § 176.170(d). If the fin- used in accordance with a prior sanc- ished food-contact article is itself the tion of approval. subject of a regulation in parts 174 (c) Conditions of use. The polymers through 178 and § 179.45 of this chapter, may be safely used as articles or as it shall also comply with any specifica- components of articles intended for use tions and limitations prescribed for it in producing, manufacturing, proc- by the regulation. essing, preparing, treating, packaging, [49 FR 29578, July 23, 1984] transporting, or holding food, including processing of packaged food at temperatures up to 121 °C (250 °F). Subpart C—Substances for Use (d) Specifications and limitations. The Only as Components of Arti- vinylidene chloride/methyl acrylate/ cles Intended for Repeated methyl methacrylate basic polymers Use and/or finished food-contact articles meet the following specifications and § 177.2210 Ethylene polymer, chloro- limitations: sulfonated. (1)(i) The basic vinylidene chloride/ Ethylene polymer, chlorosulfonated methyl acrylate/methyl methacrylate as identified in this section may be polymers contain not more than 2 safely used as an article or component weight percent of polymer units de- of articles intended for use in contact

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with food, subject to the provisions of § 177.2250 Filters, microporous poly- this section. meric. (a) Ethylene polymer, chloro- Microporous polymeric filters identi- sulfonated is produced by chloro- fied in paragraph (a) of this section sulfonation of a carbon tetrachloride may be safely used, subject to the pro- solution of polyethylene with chlorine visions of this section, to remove par- and sulfuryl chloride. ticles of insoluble matter in producing, (b) Ethylene polymer, chloro- manufacturing, processing, and pre- sulfonated shall meet the following paring bulk quantities of liquid food. specifications: (a) Microporous polymeric filters (1) Chlorine not to exceed 25 percent consist of a suitably permeable, contin- by weight. uous, polymeric matrix of polyvinyl (2) Sulfur not to exceed 1.15 percent chloride, vinyl chloride-propylene, or by weight. vinyl chloride-vinyl acetate, in which finely divided silicon dioxide is embed- (3) Molecular weight is in the range ded. Cyclohexanone may be used as a of 95,000 to 125,000. solvent in the production of the filters. Methods for the specifications in this (b) Any substance employed in the paragraph (b), titled ‘‘Chlorine and production of microporous polymeric Bromine—Coulometric Titration Meth- filters that is the subject of a regula- od by Aminco Chloridometer,’’ tion in parts 170 through 189 of this ‘‘Hypolon Synthetic Rubber—Deter- chapter must conform with any speci- mination of Sulfur by Parr Bomb,’’ and fication in such regulation. ASTM method D2857–70 (Reapproved (c) Cyclohexanone when used as a sol- 1977), ‘‘Standard Test Method for Di- vent in the production of the filters lute Solution Viscosity of Polymers,’’ shall not exceed 0.35 percent by weight are incorporated by reference. Copies of the microporous polymeric filters. of the ASTM method may be obtained (d) The microporous polymeric filters may be colored with colorants used in from the American Society for Testing accordance with § 178.3297 of this chap- Materials, 1916 Race St., Philadelphia, ter. PA 19103. Copies of the other two meth- (e) The temperature of food being ods are available from the Center for processed through the microporous pol- Food Safety and Applied Nutrition ymeric filters shall not exceed 180 °F. (HFS–200), Food and Drug Administra- (f) The microporous polymeric filters tion, 5100 Paint Branch Pkwy., College shall be maintained in a sanitary man- Park, MD 20740. Copies of all three ner in accordance with good manufac- methods may be examined at the Office turing practice so as to prevent poten- of the Federal Register, 800 North Cap- tial microbial adulteration of the food. itol Street, NW., suite 700, Washington, (g) To assure safe use of the micro- DC 20408. porous polymeric filters, the label or (c) The additive is used as the article, labeling shall include adequate direc- or a component of articles, intended for tions for a pre-use treatment, con- use as liners and covers for reservoirs sisting of washing with a minimum of intended for the storage of water for 2 gallons of potable water at a tem- drinking purposes. perature of 180 °F for each square foot (d) Substances permitted by § 177.2600 of filter, prior to the filter’s first use in may be employed in the preparation of contact with food. ethylene polymers, chlorosulfonated, [42 FR 14572, Mar. 15, 1977, as amended at 56 subject to any limitations prescribed FR 42933, Aug. 30, 1991] therein. (e) The finished ethylene copolymers, § 177.2260 Filters, resin-bonded. chlorosulfonated shall conform to Resin-bonded filters may be safely § 177.2600(e) and (g). used in producing, manufacturing, processing, and preparing food, subject [42 FR 14572, Mar. 15, 1977, as amended at 49 to the provisions of this section. FR 10111, Mar. 19, 1984; 54 FR 24898, June 12, (a) Resin-bonded filters are prepared 1989] from natural or synthetic fibers to

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which have been added substances re- Ammonium. quired in their preparation and fin- Calcium. ishing, and which are bonded with res- Magnesium. ins prepared by condensation or polym- Potassium. Sodium. erization of resin-forming materials, Triethanolamine. together with adjuvant substances re- Fatty acid (C10-C18) mono- and diesters of quired in their preparation, applica- polyoxyethylene glycol (molecular weight tion, and curing. 400–3,000). (b) The quantity of any substance Methyl esters of fatty acids (C10-C18). employed in the production of the Mineral oil. resin-bonded filter does not exceed the Polybutene, hydrogenated; complying with the identity prescribed under § 178.3740 (b) amount reasonably required to accom- of this chapter. plish the intended physical or technical Polyoxyethylene (4 mols) ethylenediamine effect or any limitation further pro- monolauramide for use only in lubricant vided. formulations for rayon fiber finishing and (c) Any substance employed in the at a usage level not to exceed 10 percent by production of resin-bonded filters that weight of the lubricant formulations. is the subject of a regulation in parts Ricebran oil. 174, 175, 176, 177, 178 and § 179.45 of this Titanium dioxide. chapter conforms with any specifica- (3) Resins: tion in such regulation. (d) Substances employed in the pro- Acrylic polymers produced by polymerizing ethyl acrylate alone or with one or more of duction of resin-bonded filters include the monomers: Acrylic acid, acrylonitrile, the following, subject to any limita- N-methylolacrylamide, and styrene. The tions provided: finished copolymers shall contain at least 70 weight percent of polymer units derived LIST OF SUBSTANCES AND LIMITATIONS from ethyl acrylate, no more than 2 weight percent of total polymer units derived (1) Fibers: from acrylic acid, no more than 10 weight Cellulose pulp. percent of total polymer units derived Cotton. from acrylonitrile, no more than 2 weight Nylon. (From nylon resins complying with percent of total polymer units derived the provisions of applicable regulations in from N-methylolacrylamide, and no more subchapter B of this chapter. than 25 weight percent of total polymer Polyethylene terephthalate complying in units derived from styrene. For use only as composition with the provisions of provided in paragraph (m) of this section. § 177.1630; for use in inline filtration only as Melamine-formaldehyde. provided for in paragraphs (e) and (f) of Melamine-formaldehyde chemically modified this section. with one or more of the amine catalysts Rayon (viscose). identified in § 175.300(b)(3)(xiii) of this chapter. (2) Substances employed in fiber fin- Melamine-formaldehyde chemically modified ishing: with methyl alcohol. BHT. Melamine-formaldehyde chemically modified Butyl (or isobutyl) palmitate or stearate. with urea; for use only as provided for in 2,5-Di-tert-butyl hydroquinone for use only in paragraphs (e), (f), (g), (h), and (i) of this lubricant formulations for rayon fiber fin- section. ishing and at a usage level not to exceed Phenol-formaldehyde resins. 0.1 percent by weight of the lubricant for- Polyvinyl alcohol. mulations. Polyvinyl alcohol with the copolymer of Dimethylpolysiloxane. acrylic acid-allyl sucrose. 4-Ethyl-4-hexadecyl morpholinium ethyl sul- Polyvinyl alcohol with melamine formalde- fate for use only as a lubricant in the man- hyde. ufacture of polyethylene terephthalate fi- Polyvinyl acetate with melamine formalde- bers specified in paragraph (d)(1) of this hyde. p- section at a level not to exceed 0.03 percent -Toluenesulfonamide-formaldehyde chemi- by weight of the finished fibers. cally modified with one or more of the amine catalysts identified in § 175.300 Fatty acid (C10-C18) diethanolamide condensates. (b)(3)(xiii) of this chapter. Fatty acids derived from animal or vegetable (4) Adjuvant substances: fats and oils, and salts of such acids, single or mixed, as follows: Dimethyl polysiloxane with methylcellulose Aluminum. and sorbic acid (as an antifoaming agent).

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Phosphoric acid. extractives not to exceed 4 percent, by (5) Colorants: Colorants used in ac- weight, of the filter. cordance with § 178.3297 of this chapter. (2) Conditions of use. It is used in com- (e) Resin-bonded filters conforming mercial filtration of bulk quantities of with the specifications of paragraph (e) nonalcoholic, aqueous foods having a (1) of this section are used as provided pH above 5.0. in paragraph (e)(2) of this section: (j) Resin-bonded filters conforming (1) Total extractives. The finished fil- with the specifications of paragraph (j) ter, when exposed to distilled water at (1) of this section are used as provided 100 °F for 2 hours, yields total extrac- in paragraph (j)(2) of this section: tives not to exceed 2.8 percent by (1) Total extractives. The finished fil- weight of the filter. ter, when exposed to 5 percent (by (2) Conditions of use. It is used to fil- weight) acetic acid for 2 hours at a ter milk or potable water at operating temperature equivalent to, or higher temperatures not to exceed 100 °F. than, the filtration temperature of the (f) Resin-bonded filters conforming with the specifications of paragraph (f) aqueous food, yields total extractives (1) of this section are used as provided not to exceed 4 percent, by weight, of in paragraph (e)(2) of this section: the filter. (1) Total extractives. The finished fil- (2) Conditions of use. It is used in com- ter, when exposed to distilled water at mercial filtration of bulk quantities of 145 °F for 2 hours, yields total extrac- nonalcoholic, aqueous foods having a tives not to exceed 4 percent by weight pH of 5.0 or below. of the filter. (k) Resin-bonded filters conforming (2) Conditions of use. It is used to fil- with the specifications of paragraph (k) ter milk or potable water at operating (1) of this section are used as provided temperatures not to exceed 145 °F. in paragraph (k)(2) of this section: (g) Resin-bonded filters conforming (1) Total extractives. The finished fil- with the specifications of paragraph (g) ter, when exposed to 8 percent (by vol- (1) of this section are used as provided ume) ethyl alcohol in distilled water in paragraph (g)(2) of this section: for 2 hours at a temperature equivalent (1) Total extractives. The finished fil- to, or higher than, the filtration tem- ter, when exposed to n-hexane at reflux perature of the alcoholic beverage, temperature for 2 hours, yields total yields total extractives not to exceed 4 extractives not to exceed 0.5 percent by weight of the filter. percent, by weight, of the filter. (2) Conditions of use. It is used to fil- (2) Conditions of use. It is used in com- ter edible oils. mercial filtration of bulk quantities of (h) Resin-bonded filters conforming alcoholic beverages containing not with the specifications of paragraph (h) more than 8 percent alcohol. (1) of this section are used as provided (l) Resin-bonded filters conforming in paragraph (h)(2) of this section: with the specifications of paragraph (l) (1) Total extractives. The finished fil- (1) of this section are used as provided ter, when exposed to distilled water at in paragraph (l)(2) of this section: 212 °F for 2 hours, yields total extrac- (1) Total extractives. The finished fil- tives not to exceed 4 percent by weight ter, when exposed to 50 percent (by vol- of the filter. ume) ethyl alcohol in distilled water (2) Conditions of use. It is used to fil- for 2 hours at a temperature equivalent ter milk, coffee, tea, and potable water to, or higher than, the filtration tem- ° at temperatures not to exceed 212 F. perature of the alcoholic beverage, (i) Resin-bonded filters conforming yields total extractives not to exceed 4 with the specifications of paragraph (i) percent, by weight, of the filter. (1) of this section are used as provided in paragraph (i)(2) of this section: (2) Conditions of use. It is used in com- (1) Total extractives. The finished fil- mercial filtration of bulk quantities of ter, when exposed to distilled water for alcoholic beverages containing more 2 hours at a temperature equivalent to, than 8 percent alcohol. or higher than, the filtration tempera- (m) Resin-bonded filters fabricated ture of the aqueous food, yields total from acrylic polymers as provided in

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paragraph (d)(3) of this section to- 4,4′-Methylenedianiline ...... Do. gether with other substances as pro- m-Phenylenediamine ...... Do. Tetrahydrophthalic anhydride Do. vided in paragraph (d), (1), (2), and (4) of this section may be used as follows: (c) In accordance with good manufac- (1) The finished filter may be used to turing practice, finished articles con- filter milk or potable water at oper- taining the resins shall be thoroughly ating temperatures not to exceed 100 cleansed prior to their first use in con- °F, provided that the finished filter tact with food. when exposed to distilled water at 100 (d) The provisions of this section are °F for 2 hours yields total extractives not applicable to 4,4′-isopropylidenedi- not to exceed 1 percent by weight of phenol-epichlorohydrin resins listed in the filter. (2) The finished filter may be used to other sections of parts 174, 175, 176, 177, filter milk or potable water at oper- 178 and 179 of this chapter. ating temperatures not to exceed 145 [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, °F, provided that the finished filter 1984] when exposed to distilled water at 145 °F for 2 hours yields total extractives § 177.2355 Mineral reinforced nylon not to exceed 1.2 percent by weight of resins. the filter. Mineral reinforced nylon resins iden- (n) Acrylonitrile copolymers identi- tified in paragraph (a) of this section fied in this section shall comply with may be safely used as articles or com- the provisions of § 180.22 of this chap- ponents of articles intended for re- ter. peated use in contact with nonacidic [42 FR 14572, Mar. 15, 1977, as amended at 56 food (pH above 5.0) and at use tempera- FR 42933, Aug. 30, 1991] tures not exceeding 212 °F. in accordance with the following prescribed con- § 177.2280 4,4′-Isopropylidenediphenol- ditions: epichlorohydrin thermosetting (a) For the purpose of this section epoxy resins. the mineral reinforced nylon resins 4,4′-Isopropylidenediphenol-epichlo- consist of nylon 66, as identified in and rohydrin thermosetting epoxy resins complying with the specifications of may be safely used as articles or com- § 177.1500, reinforced with up to 40 ponents of articles intended for re- weight percent of calcium silicate and peated use in producing, manufac- up to 0.5 weight percent 3- turing, packing, processing, preparing, (triethoxysilyl) propylamine (Chemical treating, packaging, transporting, or Abstracts Service Registry No. holding food, in accordance with the 000919302) based on the weight of the following prescribed conditions: calcium silicate. (a) The basic thermosetting epoxy (b) The mineral reinforced nylon res- resin is made by reacting 4,4′- ins may contain up to 0.2 percent by isopropylidenediphenol with epichloro- weight of titanium dioxide as an op- hydrin. tional adjuvant substance. (b) The resin may contain one or (c) The mineral reinforced nylon res- more of the following optional sub- ins with or without the optional substances provided the quantity used stance described in paragraph (b) of does not exceed that reasonably re- this section, and in the form of 1⁄8-inch quired to accomplish the intended ef- molded test bars, when extracted with fect: the solvents, i.e., distilled water and 50 Allyl glycidyl ether ...... As curing system additive. percent (by volume) ethyl alcohol in Di- and tri-glycidyl ester mix- As modifier at levels not to ture resulting from the re- exceed equal parts by distilled water, at reflux temperature action of epichlorohydrin weight of the 4,4′- for 24 hours using a volume-to-surface with mixed dimers and isopropylidenediphenol- ratio of 2 milliliters of solvent per trimers of unsaturated C18 epichlorohydrin basic resin square inch of surface tested, shall monobasic fatty acids de- and limited to use in con- rived from animal and veg- tact with alcoholic bev- meet the following extractives limita- etable fats and oils. erages containing not more tions: than 8 percent of alcohol. (1) Total extractives not to exceed 5.0 1,2-Epoxy-3-phenoxypropane As curing system additive. Glyoxal ...... Do. milligrams per square inch of food-con- 4,4′-Isopropylidenediphenol ... Do. tact surface tested for each solvent.

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(2) The ash after ignition of the ex- (b) Optional adjuvant substances. The tractives described in paragraph (c)(1) perfluorocarbon cured elastomer iden- of this section, not to exceed 0.5 milli- tified in paragraph (a) of this section gram per square inch of food-contact may contain the following optional ad- surface tested. juvant substances, subject to any limi- (d) In accordance with good manufac- tations cited on their use: turing practice, finished articles con- (1) Substances generally recognized taining the mineral reinforced nylon as safe (GRAS) in food or food pack- resins shall be thoroughly cleansed aging. prior to their first use in contact with (2) Substances used in accordance food. with a prior sanction. (3) Substances authorized under ap- [42 FR 54533, Oct. 7, 1977, as amended at 42 FR plicable regulations in this part and in 61594, Dec. 6, 1977] parts 175 and 178 of this chapter and subject to any limitations prescribed § 177.2400 Perfluorocarbon cured therein. elastomers. (4) Substances identified in this para- Perfluorocarbon cured elastomers graph (b)(4) subject to such limitations identified in paragraph (a) of this sec- as are provided:

tion may be safely used as articles or Substances Limitations components of articles intended for repeated use in contact with nonacid Carbon black (channel proc- Not to exceed 15 parts per ess of furnace combustion 100 parts of the food (pH above 5.0), subject to the pro- process) (CAS Reg. No. terpolymer. visions of this section. 1333–86–4). (a) Identity. (1) For the purpose of Magnesium oxide (CAS Reg. Not to exceed 5 parts per No. 1309–48–4). 100 parts of the this section, perfluorocarbon cured terpolymer. elastomers are produced by terpolymerizing tetrafluorethylene (c) Specifications—(1) Infrared identi- (CAS Reg. No. 116–14–3), fication. Perfluorocarbon cured perfluoromethyl vinyl ether (CAS Reg. elastomers may be identified by the No. 1187–93–5), and perfluoro-2- characteristic infrared spectra of the phenoxypropyl vinyl ether (CAS Reg. pyrolysate breakdown product that is No. 24520–19–2) and subsequent curing of obtained by heating and decomposing the terpolymer (CAS Reg. No. 26658–70– the elastomer using the method enti- 8) using the crosslinking agent, phenol, tled ‘‘Qualitative Identification of 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl) Kalrez by Infrared Examination of ethylidene] bis-,dipotassium salt (CAS Pyrolysate.’’ This method is incor- Reg. No. 25088–69–1) and accelerator, porated by reference. Copies of the 1,4,7,10,13,16-hexaoxacyclooctadecane method are available from the Center (CAS Reg. No. 17455–13–9). for Food Safety and Applied Nutrition (2) The perfluorocarbon base polymer (HFS–200), Food and Drug Administra- tion, 5100 Paint Branch Pkwy., College shall contain no less than 40 weight- Park, MD 20740, or available for inspec- percent of polymer units derived from tion at the Office of the Federal Reg- tetrafluoroethylene, no less than 40 ister, 800 North Capitol Street, NW., weight-percent of polymer units de- suite 700, Washington, DC 20408. rived from perfluoromethyl vinyl ether (2) Thermogravimetry. Perfluorocarbon and no more than 5 weight-percent cured elastomers have a major decom- polymer units derived from perfluoro-2- position peak occurring at 490 ° ±15 °C phenoxy-propyl vinyl ether. (914 °F). Less than 1.5 percent of the (3) The composition limitations of elastomers will volatilize below 400 °C the cured elastomer, calculated as (752 °F) when run under nitrogen at a 10 parts per 100 parts of terpolymer, are °C or 18 °F per minute heating rate as follows: using a Du Pont Thermal Analyzer Phenol, 4,4′-[2,2,2-trifluoro-1- Model 1099 with Model 951 TGA unit or (trifluoromethyl)-ethylidene] bis- the equivalent. ,dipotassium salt—not to exceed 5 parts. (d) Extractive limitations. Articles fab- 1,4,7,10,13,16-Hexaoxacyclo-octadecane—not ricated from perfluorocarbon cured to exceed 5 parts. elastomers having a thickness of at

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least 1.0 millimeter (0.039 inch) when desired technical or physical properties extracted at reflux temperatures for 2 include the following: hours separately with distilled water, Asbestos fiber. 50 percent ethanol, and n-heptane, Barium hydroxide ...... For use as catalyst. shall meet the following extractability Calcium stearate ...... For use as lubricant. limits: Carbon black (channel proc- (1) Total extractives not to exceed 3.1 ess). milligrams per square decimeter (0.2 Diatomaceous earth. Glass fiber. milligrams per square inch). Hexamethylenetetramine ...... For use as curing agent. (2) Fluoride extractives calculated as Mica. fluorine not to exceed 0.47 milligram Oxalic acid ...... For use as catalyst. per square decimeter (0.03 milligram Zinc stearate ...... For use as lubricant. per square inch). (c) The finished food-contact article, (e) Conditions of use. In accordance when extracted with distilled water at with current good manufacturing prac- reflux temperature for 2 hours, using a tice, finished food contact articles con- volume-to-surface ratio of 2 milliliters taining the perfluorocarbon cured of distilled water per square inch of elastomers shall be thoroughly cleaned surface tested, shall meet the following prior to their first use in contact with extractives limitations: food. (1) Total extractives not to exceed [49 FR 43050, Oct. 26, 1984] 0.15 milligram per square inch of food- contact surface. § 177.2410 Phenolic resins in molded (2) Extracted phenol not to exceed articles. 0.005 milligram per square inch of food- Phenolic resins identified in this sec- contact surface. tion may be safely used as the food- (3) No extracted aniline when tested contact surface of molded articles in- by a spectrophotometric method sen- tended for repeated use in contact with sitive to 0.006 milligram of aniline per- nonacid food (pH above 5.0), in accord- square inch of food-contact surface. ance with the following prescribed con- (d) In accordance with good manufac- ditions: turing practice, finished molded arti- (a) For the purpose of this section, cles containing the phenolic resins the phenolic resins are those produced shall be thoroughly cleansed prior to when one or more of the phenols listed their first use in contact with food. in paragraph (a)(1) of this section are made to react with one or more of the § 177.2415 Poly(aryletherketone) res- aldehydes listed in paragraph (a)(2) of ins. this section, with or without aniline Poly(aryletherketone) resins identi- and/or anhydro-formaldehyde aniline fied in paragraph (a) of this section (hexahydro-1, 3,5-triphenyl-s-triazine): may be safely used as articles or com- (1) Phenols: ponents of articles intended for repeated use in contact with food subject p-tert-Amylphenol. p-tert-Butylphenol. to the provisions of this section. o-, m-, and p-Cresol. (a) Identity. For the purposes of this p-Octylphenol. section, poly(aryletherketone) resins Phenol. are poly(p-oxyphenylene p- o- and p-Phenylethylphenol mixture pro- oxyphenylene p-carboxyphenylene) res- duced when phenol is made to react with ins (CAS Reg. No. 29658–26–2) produced styrene in the presence of sulfuric acid cat- by the polymerization of hydroquinone alyst. and 4,4′-difluorobenzophenone, and (2) Aldehydes: have a minimum weight-average molecular weight of 12,000, as determined Acetaldehyde. by gel permeation chromatography in Formaldehyde. comparison with polystyrene stand- Paraldehyde. ards, and a minimum mid-point glass (b) Optional adjuvant substances em- transition temperature of 142 °C, as de- ployed in the production of the phe- termined by differential scanning nolic resins or added thereto to impart calorimetry.

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(b) Optional adjuvant substances. The Fumaric. basic resins identified in paragraph (a) Isophthalic. may contain optional adjuvant sub- Maleic. stances used in their production. These Methacrylic. adjuvants may include substances de- Orthophthalic. Sebacic. scribed in § 174.5(d) of this chapter and Terephthalic. the following: Trimellitic. Substance Limitations (2) Polyols and polyepoxides: Diphenyl sulfone ...... Not to exceed 0.2 percent Butylene glycol. by weight as a residual Diethylene glycol. solvent in the finished 2,2-Dimethyl-1,3-propanediol. basic resin. Dipropylene glycol. (c) Extractive limitations. The finished Ethylene glycol. Glycerol. food contact article, when extracted at 4,4′-Isopropylidenediphenol-epichlorohydrin. reflux temperatures for 2 hours with Mannitol. the following four solvents, yields in a-Methyl glucoside. each extracting solvent net chloroform Pentaerythritol. soluble extractives not to exceed 0.05 Polyoxypropylene ethers of 4,4′-isopropylide- milligrams per square inch of food con- nediphenol (containing an average of 2–7.5 tact surface: Distilled water, 50 percent moles of propylene oxide). (by volume) ethanol in distilled water, Propylene glycol. 3 percent acetic acid in distilled water, Sorbitol. and n-heptane. In testing the final food Trimethylol ethane. Trimethylol propane. contact article, a separate test sample 2,2,4-Trimethyl-1,3-pentanediol. shall be used for each extracting solvent. (3) Cross-linking agents: [63 FR 20315, Apr. 24, 1998] Butyl acrylate. Butyl methacrylate. § 177.2420 Polyester resins, cross- Ethyl acrylate. linked. Ethylhexyl acrylate. Methyl acrylate. Cross-linked polyester resins may be Methyl methacrylate. safely used as articles or components Styrene. of articles intended for repeated use in Triglycidyl isocyanurate (CAS Reg. No. 2451– contact with food, in accordance with 62–9), for use only in coatings contacting the following prescribed conditions: bulk quantities of dry food of the type (a) The cross-linked polyester resins identified in § 176.170(c) of this chapter, are produced by the condensation of table 1, under type VIII. one or more of the acids listed in para- Vinyl toluene. graph (a)(1) of this section with one or (b) Optional adjuvant substances em- more of the alcohols or epoxides listed ployed to facilitate the production of in paragraph (a)(2) of this section, fol- the resins or added thereto to impart lowed by copolymerization with one or desired technical or physical properties more of the cross-linking agents listed include the following, provided that in paragraph (a)(3) of this section: the quantity used does not exceed that (1) Acids: reasonably required to accomplish the Adipic. intended physical or technical effect Fatty acids, and dimers thereof, from nat- and does not exceed any limitations ural sources. prescribed in this section:

Limitations (limits of addition expressed as percent by weight List of substances of finished resin)

1. Inhibitors: Total not to exceed 0.08 percent. Benzoquinone ...... 0.01 percent. tert-Butyl catechol. TBHQ. Di-tert-butyl hydroquinone. Hydroquinone. 2. Accelerators: Total not to exceed 1.5 percent. Benzyl trimethyl ammonium chloride ...... 0.05 percent.

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Limitations (limits of addition expressed as percent by weight List of substances of finished resin)

Calcium naphthenate. Cobalt naphthenate. Copper naphthenate. N, N-Diethylaniline ...... 0.4 percent. N, N-Dimethylaniline ...... Do. Ethylene guanidine hydrochloride ...... 0.05 percent. 3. Catalysts: Total not to exceed 1.5 percent, except that methyl ethyl ketone peroxide may be used as the sole catalyst at levels not to exceed 2 percent. Azo-bis-isobutyronitrile. Benzoyl peroxide. tert-Butyl perbenzoate. Chlorbenzoyl peroxide. Cumene hydroperoxide. Dibutyltin oxide (CAS Reg. No. 818–08–6) ...... For use in the polycondensation reaction at levels not to exceed 0.2 percent of the polyester resin. Dicumyl peroxide. Hydroxybutyltin oxide (CAS Reg. No. 2273–43–0) ...... For use in the polycondensation reaction at levels not to exceed 0.2 percent of the polyester resin. Lauroyl peroxide. p-Menthane hydroperoxide. Methyl ethyl ketone peroxide. Monobutyltin tris(2-ethylhexoate) (CAS Reg. No. 23850– For use in the polycondensation reaction at levels not to ex- 94–4). ceed 0.2 percent of the polyester resin. 4. Solvents for inhibitors, accelerators, and catalysts: Butyl benzyl phthalate (containing not more than 1.0 percent by weight of dibenzyl phthalate). Dibutyl phthalate. Diethylene glycol ...... As a solvent for benzyl trimethyl ammonium chloride or ethylene guanidine hydrochloride only. Dimethyl phthalate. Methyl alcohol. Styrene. Triphenyl phosphate. 5. Reinforcements: Asbestos. Glass fiber. Polyester fiber produced by the condensation of one or more of the acids listed in paragraph (a)(1) of this section with one or more of the alcohols listed in paragraph (a)(2) of this section. 6. Miscellaneous materials: Castor oil, hydrogenated. a-Methylstyrene. Polyethylene glycol 6000. Silicon dioxide. Wax, petroleum ...... Complying with § 178.3710 of this chapter.

(c) The cross-linked polyester resins, lating solvent is water or 8 or 50 per- with or without the optional sub- cent alcohol. stances described in paragraph (b) of (2) Total nonvolatile extractives not this section, and in the finished form in to exceed 0.1 milligram per square inch which they are to contact food, when of food-contact surface tested when the extracted with the solvent or solvents prescribed food-simulating solvent is characterizing the type of food and heptane. under the conditions of time and tem- (d) In accordance with good manufac- perature characterizing the conditions turing practice, finished articles con- of their intended use, as determined taining the cross-linked polyester res- from tables 1 and 2 of § 176.170(c) of this ins shall be thoroughly cleansed prior chapter, shall meet the following ex- to their first use in contact with food. tractives limitations: (1) Net chloroform-soluble extrac- [42 FR 14572, Mar. 15, 1977, as amended at 48 FR 37618, Aug. 19, 1983; 54 FR 48858, Nov. 28, tives not to exceed 0.1 milligram per 1989] square inch of food-contact surface tested when the prescribed food-simu-

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§ 177.2430 Polyether resins, 800 North Capitol St. NW., suite 700, chlorinated. Washington, DC. Chlorinated polyether resins may be (b) The basic resins identified in safely used as articles or components paragraphs (a)(1) and (a)(2) of this sec- of articles intended for repeated use in tion may contain optional adjuvant producing, manufacturing, packing, substances described in § 174.5(d) of this processing, preparing, treating, pack- chapter and the following: aging, transporting, or holding food, in List of substances Limitations accordance with the following prescribed conditions: Diphenylsulfone ...... Not to exceed 0.2 percent as re- (a) The chlorinated polyether resins sidual solvent in the finished basic resin described in para- are produced by the catalytic polym- graph (a)(1) of this section. erization of 3,3-bis(chloromethyl)- Dimethyl sulfoxide ...... Not to exceed 0.01 percent as oxetane, and shall contain not more residual solvent in the finished than 2 percent residual monomer. basic resin described in paragraph (a)(1) of this section. (b) In accordance with good manufac- N-methyl-2-pyrrolidone ..... Not to exceed 0.01 percent as turing practice, finished articles con- residual solvent in the finished taining the chlorinated polyether res- basic resin described in para- ins shall be thoroughly cleansed prior graph (a)(2) of this section. to their first use in contact with food. (c) The finished food-contact article, § 177.2440 Polyethersulfone resins. when extracted at reflux temperatures for 2 hours with the following four sol- Polyethersulfone resins identified in vents, yields net chloroform-soluble ex- paragraph (a) of this section may be tractives in each extracting solvent safely used as articles or components not to exceed 0.02 milligram per square of articles intended for repeated use in inch of food-contact surface: distilled contact with food in accordance with water, 50 percent (by volume) ethyl al- the following prescribed conditions: cohol in distilled water, 3 percent ace- (a) For the purpose of this section, tic acid in distilled water, and n- polyethersulfone resins are: heptane. (Note: In testing the finished (1) Poly(oxy-p-phenylenesulfonyl-p- food-contact article, use a separate phenylene) resins (CAS Reg. No. 25667– test sample for each required extract- 42–9), which have a minimum number ing solvent.) average molecular weight of 16,000. (d) In accordance with good manufac- ′ (2) 1,1 -sulfonylbis[4-chlorobenzene] turing practice, finished food-contact ′ polymer with 4,4 -(1-methylethyl- articles containing the idene)bis[phenol] (maximum 8 percent) polyethersulfone resins shall be thor- and 4,4′-sulfonylbis[phenol] (minimum oughly cleansed before their first use 92 percent) (CAS Reg. No. 88285–91–0), in contact with food. which have a minimum number average molecular weight of 26,000. [44 FR 34493, June 15, 1979, as amended at 47 (3) In paragraphs (a)(1) and (a)(2) of FR 38885, Sept. 3, 1982; 49 FR 10111, Mar. 19, this section, the minimum number av- 1984; 50 FR 47211, Nov. 15, 1985; 60 FR 48648, erage molecular weight is determined Sept. 20, 1995] by reduced viscosity in dimethyl form- § 177.2450 Polyamide-imide resins. amide in accordance with ASTM method D2857–70 (Reapproved 1977), ‘‘Stand- Polyamide-imide resins identified in ard Test Method for Dilute Solution paragraph (a) of this section may be Viscosity of Polymers,’’ which is incor- safely used as components of articles porated by reference. Copies may be intended for repeated use in contact obtained from the American Society with food, in accordance with the fol- for Testing Materials, 1916 Race St., lowing prescribed conditions: Philadelphia, PA 19103, or may be ex- (a) Identity. (1) For the purpose of amined at the Division of Petition Con- this section the polyamide-imide resins trol (HFS–215), Center for Food Safety are derived from the condensation re- and Applied Nutrition, 1110 Vermont action of substantially equimolar parts Ave. NW., suite 1200, Washington, DC, of trimellitic anhydride and p,p′- or at the Office of the Federal Register, diphenylmethane diisocyanate.

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(2) The polyamide-imide resins (CAS 500 parts per million. Residual mono- Reg. No. 31957–38–7) derived from the mers are determined by gas chroma- condensation reaction of equimolar tography (the gas chromatography parts of benzoyl chloride-3,4- method titled ‘‘Amide-Imide Polymer dicarboxylic anhydride and 4,4′- Analysis—Analysis of Monomer Con- diphenylmethanediamine. tent,’’ is incorporated by reference in (b) Specifications. (1) Polyamide-imide accordance with 5 U.S.C. 552(a). Copies resins identified in paragraph (a)(1) of are available from the Center for Food this section shall have a nitrogen con- Safety and Applied Nutrition (HFS– tent of not less than 7.8 weight percent 200), Food and Drug Administration, and not more than 8.2 weight percent. 5100 Paint Branch Pkwy., College Park, Polyamide-imide resins identified in MD 20740, or available for inspection at paragraph (a)(2) of this section shall the Office of the Federal Register, 800 have a nitrogen content of not less North Capitol Street, NW., suite 700, than 7.5 weight percent and not more Washington, DC). than 7.8 weight percent. Nitrogen content is determined by the Dumas Nitro- (c) Extractive limitations are appli- gen Determination as set forth in the cable to the polyamide-imide resins ‘‘Official Methods of Analysis of the identified in paragraphs (a) (1) and (2) Association of Official Analytical of this section in the form of films of 1 Chemists,’’ 13th Ed. (1980), sections mil uniform thickness after coating ° 7.016–7.020, which is incorporated by and heat curing at 600 F for 15 minutes reference in accordance with 5 U.S.C. on stainless steel plates, each having 552(a). Copies may be obtained from the such resin-coated surface area of 100 Association of Official Analytical square inches. The cured-resin film Chemists International, 481 North coatings shall be extracted in accord- Frederick Ave., suite 500, Gaithersburg, ance with the method described in MD 20877–2504, or may be examined at § 176.170(d)(3) of this chapter, using a the Office of the Federal Register, 800 plurality of spaced, coated stainless North Capitol Street, NW., suite 700, steel plates, exposed to the respective Washington, DC. food simulating solvents. The resin (2) Polyamide-imide resins identified shall meet the following extractive in paragraph (a)(1) of this section shall limitations under the corresponding have a solution viscosity of not less extraction conditions: than 1.200. Polyamide-imide resins (1) Distilled water at 250 °F for 2 identified in paragraph (a)(2) of this hours: Not to exceed 0.01 milligram per section shall have a solution viscosity square inch. of not less than 1.190. Solution vis- (2) Three percent acetic acid at 212 °F cosity shall be determined by a method for 2 hours: Not to exceed 0.05 milli- titled ‘‘Solution Viscosity’’ which is in- gram per square inch. corporated by reference in accordance (3) Fifty percent ethyl alcohol at 160 with 5 U.S.C. 552(a). Copies are avail- °F for 2 hours: Not to exceed 0.03 milli- able from the Center for Food Safety gram per square inch. and Applied Nutrition (HFS–200), Food (4) n-Heptane at 150 °F for 2 hours: and Drug Administration, 5100 Paint Not to exceed 0.05 milligram per square Branch Pkwy., College Park, MD 20740, inch. or available for inspection at the Office of the Federal Register, 800 North Cap- (d) In accordance with good manufac- itol Street, NW., suite 700, Washington, turing practice, those food contact ar- DC. ticles, having as components the poly- (3) The polyamide-imide resins iden- amide-imide resins identified in para- tified in paragraph (a)(1) of this section graph (a) of this section and intended are heat cured at 600 °F for 15 minutes for repeated use shall be thoroughly when prepared for extraction tests and cleansed prior to their first use in con- the residual monomers: p,p- tact with food. diphenylmethane diisocyanate should [42 FR 14572, Mar. 15, 1977, as amended at 47 not be present at greater than 100 parts FR 11845, Mar. 19, 1982; 49 FR 10111, Mar. 19, per million and trimellitic anhydride 1984; 54 FR 24898, June 12, 1989; 54 FR 43170, should not be present at greater than Oct. 23, 1989; 61 FR 14481, Apr. 2, 1996]

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§ 177.2460 Poly(2,6-dimethyl-1,4-phen- (i) Solvent: Chloroform, reagent grade ylene) oxide resins. containing 0.01 percent tert- The poly(2,6-dimethyl-1,4-phenylene) butylcatechol. oxide resins identified in paragraph (a) (ii) Resin sample: Powdered resin ob- of this section may be used as an arti- tained from production prior to mold- cle or as a component of an article in- ing or extrusion. tended for use in contact with food sub- (iii) Viscometer: Cannno-Ubbelohde se- ject to the provisions of this section. ries 25 dilution viscometer (or equiva- (a) Identity. For the purposes of this lent). section, poly(2,6-dimethyl-1,4-phen- (iv) Calculation: The calculation ylene) oxide resins consist of basic res- method used is that described in appen- ins produced by the oxidative coupling dix X.1.3 (ASTM method D1243–79, cited of 2,6-xylenol such that the finished and incorporated by reference in para- basic resins meet the specifications graph (c)(1) of this section) with the re- and extractives limitations prescribed duced viscosity determined for three in paragraph (c) of this section. concentration levels (0.4, 0.2, and 0.1 (b) Optional adjuvant substances. The gram per deciliter) and extrapolated to basic poly(2,6-dimethyl-1,4-phenylene) zero concentration for intrinisic vis- oxide resins identified in paragraph (a) cosity. The following formula is used of this section may contain optional for determining reduced viscosity: adjuvant substances required in the − production of such basic resins. The op- Reduced viscosity in terms = tto tional adjuvant substances required in of deciliters per gram × the production of the basic poly(2,6-di- tco methyl-1,4-phenylene) oxide resins may where: include substances permitted for such t=Solution efflux time. use by regulations in parts 170 through to=Solvent efflux time. 189 of this chapter, substances gen- c=Concentration of solution in terms of erally recognized as safe in food, sub- grams per deciliter. stances used in accordance with a prior (2) Extractives limitations. Total resin sanction or approval, and the fol- extracted not to exceed 0.02 weight-per- lowing: cent when extracted with n-heptane at 160 °F for 2 hours as determined using Limitations (expressed as List of substances percent by weight of finished 200 milliliters of reagent grade n- basic resin) heptane which has been freshly dis- Diethylamine ...... Not to exceed 0.16 percent tilled before use and 25 grams of poly as residual catalyst. (2,-6-dimethyl-1,4-phenylene) oxide Methyl alcohol ...... Not to exceed 0.02 percent resin. The resin as tested is in pellet as residual solvent. Toluene ...... Not to exceed 0.2 percent as form having a particle size such that residual solvent. 100 percent of the pellets will pass through a U.S. Standard Sieve No. 6 (c) Specifications and extractives limita- and 100 percent of the pellets will be tions. The poly(2,6-dimethyl-1,4-phen- held on a U.S. Standard Sieve No. 10. ylene) oxide basic resins meet the fol- (d) Other limitations. The poly(2,6-di- lowing: methyl-1,4-phenylene) oxide resins (1) Specifications. Intrinsic viscosity identified in and complying with this is not less than 0.30 deciliter per gram section, when used as components of as determined by ASTM method D1243– the food-contact surface of any article 79, ‘‘Standard Test Method for Dilute that is the subject of a regulation in Solution Viscosity of Vinyl Chloride parts 174, 175, 176, 177, 178 and § 179.45 of Polymers,’’ which is incorporated by this chapter, shall comply with any reference, modified as follows. Copies specifications and limitations pre- of the incorporation by reference may scribed by such regulation for the arti- be obtained from the American Society cle in the finished form in which it is for Testing Materials, 1916 Race St., to contact food. Philadelphia, PA 19103, or may be ex- (e) Uses. The poly(2,6-dimethyl-1,4- amined at the Office of the Federal phenylene) oxide resins identified in Register, 800 North Capitol Street, and complying with the limitations in NW., suite 700, Washington, DC 20408. this section may be used as articles or

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components of articles intended for re- trimer of formaldehyde) and a max- peated food-contact use or as articles imum of 5 percent by weight of or components of articles intended for butanediol formal (CAS Reg. No. 25214 single-service food-contact use only 85–1). Both copolymers may have cer- under the conditions described in tain optional substances added to im- § 176.170(c) of this chapter, table 2, con- part desired technological properties to ditions of use H. the copolymer. (b) Optional adjuvant substances. The [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984; 63 FR 8852, Feb. 23, polyoxymethylene copolymer identi- 1998] fied in paragraph (a) of this section may contain optional adjuvant sub- § 177.2465 Polymethylmethacrylate/ stances required in its production. The poly(trimethoxysilylpropyl)meth- quantity of any optional adjuvant sub- acrylate copolymers. stance employed in the production of Polymethylmethacrylate/ the copolymer does not exceed the poly(trimethoxysilylpropyl) methacry- amount reasonably required to accom- late copolymers (CAS Reg. No. 26936– plish the intended technical or physical 30–1) may be safely used as components effect. Such adjuvants may include of surface primers used in conjunction substances generally recognized as safe with silicone polymers intended for re- in food, substances used in accordance peated use and complying with § 175.300 with prior sanction, substances per- of this chapter and § 177.2600, in accord- mitted under applicable regulations in ance with the following prescribed con- parts 170 through 189 of this chapter, ditions. and the following: (a) Identity. For the purpose of this (1) Stabilizers (total amount of stabi- section, polymethylmethacrylate/ lizers not to exceed 2.0 percent and poly(trimethoxysilylpropyl)methacry- amount of any one stabilizer not to ex- late copolymers are produced by the ceed 1.0 percent of polymer by weight) polymerization of methylmethacrylate Calcium ricinoleate. and Cyanoguanidine. trimethoxysilylpropylmethacrylate. Hexamethylene bis(3,5-di-tert-butyl-4- (b) Conditions of use. (1) The hydroxyhydrocinnamate) (CAS Reg. No. polymethylmethacrylate/ 35074–77–2). poly(trimethoxysilylpropyl)methacry- Melamine-formaldehyde resin. ′ late copolymers are used at levels not 2,2 -Methylenebis(4-methyl-6-tert-butylphenol). to exceed 6.0 percent by weight of the Nylon 6/66, weight ratio 2/3. primer formulation. Tetrakis [methylene (3,5-di-tert-butyl-4- (2) The copolymers may be used in hydroxyhydrocinnamate)] methane. food contact applications with all food ′ types under conditions of use B (2) Lubricant: N,N Distearoylethyl- through H as described in table 2 of enediamine. (c) (1) Polyoxymeth- § 176.170(c) of this chapter. Specifications. ylene copolymer can be identified by [59 FR 5948, Feb. 9, 1994] its characteristic infrared spectrum. (2) Minimum number average molec- § 177.2470 Polyoxymethylene copoly- ular weight of the copolymer is 15,000 mer. as determined by a method titled Polyoxymethylene copolymer identi- ‘‘Number Average Molecular Weight,’’ fied in this section may be safely used which is incorporated by reference. as an article or component of articles Copies are available from the Center intended for food-contact use in ac- for Food Safety and Applied Nutrition cordance with the following prescribed (HFS–200), Food and Drug Administra- conditions: tion, 5100 Paint Branch Pkwy., College (a) Identity. For the purpose of this Park, MD 20740, or available for inspec- section, polyoxymethylene copolymers tion at the Office of the Federal Reg- are identified as the following: The re- ister, 800 North Capitol Street, NW., action product of trioxane (cyclic suite 700, Washington, DC 20408. trimer of formaldehyde) and ethylene (d) Extractive limitations. (1) Polyoxy- oxide (CAS Reg. No. 24969–25–3) or the methylene copolymer in the finished reaction product of trioxane (cyclic form in which it is to contact food,

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when extracted with the solvent or sol- (b) Optional adjuvant substances. The vents characterizing the type of food polyoxymethylene homopolymer iden- and under conditions of time and tem- tified in paragraph (a) of this section perature as determined from tables 1 may contain optional adjuvant sub- and 2 of § 175.300(d) of this chapter, stances in its production. The quantity shall yield net chloroform-soluble ex- of any optional adjuvant substance em- tractives not to exceed 0.5 milligram ployed in the production of the per square inch of food-contact surface. homopolymer does not exceed the (2) Polyoxymethylene copolymer amount reasonably required to accom- with or without the optional sub- plish the intended effect. Such adju- stances described in paragraph (b) of vants may include substances gen- this section, when ground or cut into erally recognized as safe in food, sub- particles that pass through a U.S.A. stances used in accordance with prior Standard Sieve No. 6 and that are retained on a U.S.A. Standard Sieve No. sanction, substances permitted under 10, shall yield total extractives as fol- applicable regulations in this part, and lows: the following: (i) Not to exceed 0.20 percent by (1) Stabilizers. The homopolymer may weight of the copolymer when ex- contain one or more of the following tracted for 6 hours with distilled water stabilizers. The total amount of stabi- at reflux temperature. lizers shall not exceed 1.9 percent of (ii) Not to exceed 0.15 percent by homopolymer by weight, and the quan- weight of the copolymer when ex- tity of individual stabilizer used shall tracted for 6 hours with n-heptane at not exceed the limitations set forth reflux temperature. below: (e) Conditions of use. (1) The polyoxymethylene copolymer is for use Substances Limitations as articles or components of articles Hexamethylenebis(3,5-di-tert- At a maximum level of 1 per- intended for repeated use. butyl-4-hydroxy-hydro- cent by weight of (2) Use temperature shall not exceed cinnamate) (CAS Reg. No. homopolymer. The finished 250 °F. 35074–77–2). articles shall not be used for foods containing more (3) In accordance with good manufac- than 8 percent alcohol. turing practice, finished articles con- 2,2′-Methylenebis(4-methyl-6- At a maximum level of 0.5 taining polyoxymethylene copolymer tert-butylphenol). percent by weight of shall be thoroughly cleansed before homopolymer. Nylon 66/610/6 terpolymer, At a maximum level of 1.5 their first use in contact with food. respective proportions of percent by weight of [42 FR 14572, Mar. 15, 1977, as amended at 48 nylon polymers by weight homopolymer. are: 3/2/4. FR 56204, Dec. 20, 1983; 49 FR 5748, Feb. 15, Nylon 612/6 copolymer (CAS Do. 1984; 50 FR 1842, Jan. 14, 1985; 50 FR 20560, Reg. No. 51733-10-9), May 17, 1985; 52 FR 4493, Feb. 12, 1987, 54 FR weight ratio 6/1. 24898, June 12, 1989] Tetrakis[methylene(3,5-di-tert- At a maximum level of 0.5 butyl-4-hydroxy-hydro- percent by weight of § 177.2480 Polyoxymethylene cinnamate)] methane. homopolymer. homopolymer. ′ Polyoxymethylene homopolymer (2) Lubricant. N,N -Distearoylethyl- identified in this section may be safely enediamine. used as articles or components of arti- (3) Molding assistant. Polyethylene cles intended for food-contact use in glycol 6,000. accordance with the following pre- (c) Specifications. (1) scribed conditions: Polyoxymethylene homopolymer can (a) Identity. For the purpose of this be identified by its characteristic in- section, polyoxymethylene homopoly- frared spectrum. mer is polymerized formaldehyde (2) Minimum number average molec- [Chemical Abstracts Service Registry ular weight of the homopolymer is No. 9002–81–7]. Certain optional adju- 25,000. vant substances, described in para- (3) Density of the homopolymer is be- graph (b) of this section, may be added tween 1.39 and 1.44 as determined by to impart desired technological prop- ASTM method D1505–68 (Reapproved erties to the homopolymer.

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1979), ‘‘Standard Test Method for Den- (ii) Total extractives not to exceed sity of Plastics by the Density-Gra- 0.20 percent by weight of homopolymer dient Technique,’’ which is incor- when extracted for 6 hours with dis- porated by reference. Copies may be tilled water at reflux temperature and obtained from the American Society 0.15 percent by weight of homopolymer for Testing Materials, 1916 Race St., when extracted for 6 hours with n- Philadelphia, PA 19103, or may be ex- heptane at reflux temperature. amined at the Office of the Federal (e) Conditions of use. (1) Polyoxy- Register, 800 North Capitol Street, methylene homopolymer is for use as NW., suite 700, Washington, DC 20408. articles or components of articles in- (4) Melting point is between 172 °C tended for repeated use. and 184 °C as determined by ASTM (2) Use temperature shall not exceed method D2133–66, ‘‘Specifications for 250 °F. Acetal Resin Injection Molding and Ex- (3) In accordance with good manufac- trusion Materials’’ (Revised 1966), turing practice, finished articles con- which is incorporated by reference. taining polyoxymethylene Copies are available from American So- homopolymer shall be thoroughly ciety for Testing and Materials cleansed prior to first use in contact (ASTM), 1916 Race Street, Philadel- with food. phia, PA 19103, or available for inspection at the Office of the Federal Reg- [42 FR 14572, Mar. 15, 1977, as amended at 43 FR 44835, Sept. 29, 1978; 47 FR 11846, Mar. 19, ister, 800 North Capitol Street, NW., 1982; 47 FR 51562, Nov. 16, 1982; 49 FR 10111, suite 700, Washington, DC 20408. Mar. 19, 1984; 54 FR 24898, June 12, 1989] (d) Extractive limitations. (1) Polyoxymethylene homopolymer, in § 177.2490 Polyphenylene sulfide res- the finished form which is to contact ins. food, when extracted with the solvent Polyphenylene sulfide resins or solvents characterizing the type of (poly(1,4-phenylene sulfide) resins) may food and under conditions of time and be safely used as coatings or compo- temperature characterizing the condi- nents of coatings of articles intended tions of intended use under paragraphs for repeated use in contact with food, (c)(3) and (d) of § 175.300 of this chapter in accordance with the following pre- and as limited by paragraph (e) of this scribed conditions. section, shall yield net chloroform- (a) Polyphenylene sulfide resins con- soluble extractives not to exceed 0.5 sist of basic resins produced by the re- milligram per square inch of food-con- action of equimolar parts of p- tact surface. dichlorobenzene and sodium sulfide, (2) Polyoxymethylene homopolymer, such that the finished resins meet the with or without the optional adjuvant following specifications as determined substances described in paragraph (b) by methods titled ‘‘Oxygen Flask Com- of this section, when ground or cut into bustion-Gravimetric Method for Deter- particles that pass through a U.S.A. mination of Sulfur in Organic Com- Standard Sieve No. 6 and that are re- pounds,’’ ‘‘Determination of the Inher- tained on a U.S.A. Standard Sieve No. ent Viscosity of Polyphenylene Sul- 10, shall yield extractives as follows: fide,’’ and ‘‘Analysis for (i) Formaldehyde not to exceed 0.0050 Dichlorobenzene in Ryton percent by weight of homopolymer as Polyphenylene Sulfide,’’ which are in- determined by a method titled ‘‘Form- corporated by reference. Copies are aldehyde Release and Formaldehyde available from the Center for Food Analysis,’’ which is incorporated by Safety and Applied Nutrition (HFS– reference. Copies are available from 200), Food and Drug Administration, Center for Food Safety and Applied Nu- 5100 Paint Branch Pkwy., College Park, trition (HFS–200) Food and Drug Ad- MD 20740, or available for inspection at ministration, 5100 Paint Branch Pkwy., the Office of the Federal Register, 800 College Park, MD 20740, or available for North Capitol Street, NW., suite 700, inspection at the Office of the Federal Washington, DC 20408. Register, 800 North Capitol Street, (1) Sulfur content: 28.2–29.1 percent NW., suite 700, Washington, DC 20408. by weight of finished resin.

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(2) Minimum inherent viscosity: 0.13 § 177.2500 Polyphenylene sulfone res- deciliters per gram. ins. (3) Maximum residual p- The polyphenylene sulfone resins dichlorobenzene: 0.8 ppm. (CAS Reg. No. 31833–61–1) identified in (b) Subject to any limitations pre- paragraph (a) of this section may be scribed in parts 170 through 189 of this safely used as articles or components chapter, the following optional sub- of articles intended for repeated use in stances may be added to the contact with food, subject to the provi- polyphenylene sulfide basic resins in an sions of this section. amount not to exceed that reasonably (a) Identity. For the purpose of this required to accomplish the intended section, polyphenylene sulfone resins physical or technical effect. consist of basic resin produced by re- (1) Substances generally recognized acting polyphenylene sulfide with per- as safe in food. acetic acid such that the finished res- (2) Substances used in accordance ins meet the specifications set forth in with prior sanction or approval. paragraph (c) of this section. The (3) Substances the use of which is polyphenylene sulfide used to manufac- permitted in coatings under regula- ture polyphenylene sulfone is prepared tions in parts 170 through 189 of this by the reaction of sodium sulfide and p- chapter. (c) The finished coatings are ther- dichlorobenzene, and has a minimum mally cured at temperatures of 700 °F weight average molecular weight of and above. 5,000 Daltons. (d) Polyphenylene sulfide resin coat- (b) Optional adjuvant substances. The ings may be used in contact with food basic polyphenylene sulfone resins at temperatures not to exceed the boil- identified in paragraph (a) of this sec- ing point of water; provided that the tion may contain optional adjuvant finished cured coating, when extracted substances required in the production at reflux temperatures for 8 hours sepa- of such basic resins. These optional ad- rately with distilled water, 50 percent juvant substances may include sub- ethanol in water, and 3 percent acetic stances permitted for such use by regu- acid, yields total extractives in each lations in parts 170 through 189 of this extracting solvent not to exceed 0.02 chapter, substances generally recog- milligram per square inch of surface nized as safe in food, or substances and when extracted at reflux tempera- used in accordance with a prior sanc- ture for 8 hours with heptane yields tion or approval. total extractives not to exceed 0.1 mil- (c) Specifications. The glass transition ± ° ligram per square inch of surface. temperature of the polymer is 360 5 C (e) Polyphenylene sulfide resin coat- as determined by the use of differential ings containing perfluorocarbon resins scanning calorimetry. complying with § 177.1550 may be used [65 FR 15058, Mar. 21, 2000] in contact with food at temperatures up to and including normal baking and § 177.2510 Polyvinylidene fluoride res- frying temperatures; provided that the ins. finished cured coating, when extracted Polyvinylidene fluoride resins may at reflux temperatures for 2 hours sepa- be safely used as articles or compo- rately with distilled water, 50 percent nents of articles intended for repeated ethanol in water, 3 percent acetic acid use in contact with food, in accordance and heptane, yields total extractives in with the following prescribed condi- each extracting solvent not to exceed tions: 0.2 milligram per square inch of surface (a) For the purpose of this section, and when extracted at reflux tempera- the polyvinylidene fluoride resins con- ture for 1 hour with diphenyl ether sist of basic resins produced by the po- yields total extractives not to exceed lymerization of vinylidene fluoride. 4.5 milligrams per square inch of sur- (b) The finished food-contact article, face. when extracted at reflux temperatures [42 FR 14572, Mar. 15, 1977, as amended at 47 for 2 hours with the solvents distilled FR 11846, Mar. 19, 1982; 54 FR 24898, June 12, water, 50 percent (by volume) ethyl al- 1989] cohol in distilled water, and n-heptane,

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yields total extractives in each ex- square inch) as a thin film composite tracting solvent not to exceed 0.01 mil- on a suitable support. The maximum ligram per square inch of food-contact weight of the 2,4-toluenediisocyanate surface tested; and if the finished food- component of the thin film composite contact article is itself the subject of a is 0.47 milligrams per square decimeter regulation in parts 174, 175, 176, 177, 178 (0.03 milligrams per square inch). and § 179.45 of this chapter, it shall also (3) For the purpose of this section, comply with any specifications and the reverse osmosis membrane consists limitations prescribed for it by that of a polyaramide identified as 2,4- regulation. (NOTE: In testing the fin- diaminobenzenesulfonic acid, calcium ished food-contact article, use a sepa- salt (2:1) polymer with 1,3- rate test sample for each required ex- benzenediamine, 1,3-benzenedicarbonyl tracting solvent.) (c) In accordance with good manufac- dichloride, and 1,4-benzenedicarbonyl turing practice, finished food-contact dichloride (CAS Reg. No. 39443–76–0). articles containing the polyvinylidene The membrane is the food contact sur- fluoride resins shall be thoroughly face and may be applied as a film on a cleansed prior to their first use in con- suitable support. Its maximum weight tact with food. is 512 milligrams per square decimeter (33 milligrams per square inch). § 177.2550 Reverse osmosis mem- (4) A cross-linked high molecular branes. weight polyamide reaction product of Substances identified in paragraph poly(N-vinyl-N-methylamine) (CAS (a) of this section may be safely used as Reg. No. 31245–56–4), N,N′-bis(3- reverse osmosis membranes intended aminopropyl)ethylenediamine (CAS for use in processing bulk quantities of Reg. No. 10563–26–5), 1,3- liquid food to separate permeate from benzenedicarbonyl dichloride (CAS food concentrate or in purifying water Reg. No. 99–63–8) and 1,3,5- for food manufacturing under the fol- benzenetricarbonyl trichloride (CAS lowing prescribed conditions: Reg. No. 4422–95–1). The membrane is (a) Identity. For the purpose of this the food-contact surface. Its maximum section, reverse osmosis membranes weight is 20 milligrams per square deci- may consist of either of the following meter (1.3 milligrams per square inch) formulations: as a thin film composite on a suitable (1) A cross-linked high molecular support. weight polyamide reaction product of 1,3,5-benzenetricarbonyl trichloride (5) A polyamide reaction product of with 1,3-benzenediamine (CAS Reg. No. 1,3,5-benzenetricarbonyl trichloride 83044–99–9) or piperazine (CAS Reg. No. polymer (CAS Reg. No. 4422–95–1) with 110–85–0). The membrane is on the food- piperazine (CAS Reg. No. 110–85–0) and contact surface, and its maximum 1,2-diaminoethane (CAS Reg. No. 107– weight is 62 milligrams per square deci- 15–3). The membrane is the food-con- meter (4 milligrams per square inch) as tact layer and may be applied as a film a thin film composite on a suitable on a suitable support. Its maximum support. weight is 15 milligrams per square deci- (2) A cross-linked polyetheramine meter (1 milligram per square inch). (CAS Reg. No. 101747–84–6), identified as (b) Optional adjuvant substances. The the copolymer of epichlorohydrin, 1,2- basic polymer identified in paragraph ethanediamine and 1,2-dichloroethane, (a) of this section may contain optional whose surface is the reaction product adjuvant substances required in the of this copolymer with 2,4- production of such basic polymer. toluenediisocyanate (CAS Reg. No. of These optional adjuvant substances the final polymer is 99811–80–0) for use may include substances permitted for as the food-contact surface of reverse such use by regulations in parts 170 osmosis membranes used in processing through 186 of this chapter, substances liquid food. The composite membrane generally recognized as safe in food, is on the food-contact surface and its maximum weight is 4.7 milligrams per and substances used in accordance with square decimeter (0.3 milligrams per a prior sanction or approval.

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(c) Supports. Suitable supports for re- (1) Substances generally recognized verse osmosis membranes are mate- as safe for use in food or food pack- rials permitted for such use by regula- aging. tions in parts 170 through 186 of this (2) Substances used in accordance chapter, substances generally recog- with the provisions of a prior sanction nized as safe in food, and substances or approval. used in accordance with a prior sanc- (3) Substances that by regulation in tion or approval. parts 170 through 189 of this chapter (d) Conditions of use. (1) Reverse os- may be safely used in rubber articles, mosis membranes described in para- subject to the provisions of such regu- graphs (a)(1), (a)(2), (a)(3), and (a)(5) of lation. this section may be used in contact (4) Substances identified in this para- with all types of liquid food at tem- graph (c)(4), provided that any sub- peratures up to 80 °C (176 °F). stance that is the subject of a regula- (2) Reverse osmosis membranes de- tion in parts 174, 175, 176, 177, 178 and scribed in paragraph (a)(4) of this sec- § 179.45 of this chapter conforms with tion may be used in contact with all any specification in such regulation. types of liquid food, except food con- (i) Elastomers. taining more than 8 percent alcohol, at Acrylonitrile-butadiene copolymer. temperatures up to 80 °C (176 °F). Brominated isobutylene-isoprene copolymers (3) Reverse osmosis membranes shall complying with § 177.1210. be maintained in a sanitary manner in Butadiene-acrylonitrile-ethylene glycol accordance with current good manufac- dimethacrylate copolymers containing not turing practice so as to prevent micro- more than 5 weight percent of polymer bial adulteration of food. units derived from ethylene glycol dimethacrylate. (4) To assure their safe use, reverse Butadiene-acrylonitrile-methacrylic acid co- osmosis membranes and their supports polymer. shall be thoroughly cleaned prior to Butadiene-styrene-methacrylic acid copoly- their first use in accordance with cur- mer. rent good manufacturing practice. Chloroprene polymers. Chlorotrifluoroethylene-vinylidene fluoride [49 FR 49448, Dec. 20, 1984, as amended at 52 copolymer. FR 29668, Aug. 11, 1987; 53 FR 31835, Aug. 22, Ethylene-propylene copolymer elastomers 1988; 53 FR 32215, Aug. 24, 1988; 55 FR 8139, which may contain not more than 5 Mar. 7, 1990; 59 FR 9925, Mar. 2, 1994] weight-percent of total polymer units derived from 5-methylene-2-norbornene and/ § 177.2600 Rubber articles intended for or 5-ethylidine-2-norbornene. repeated use. Ethylene-propylene-dicyclopentadiene co- Rubber articles intended for repeated polymer. use may be safely used in producing, Ethylene-propylene-1,4-hexadiene copolymers containing no more than 8 weight manufacturing, packing, processing, percent of total polymer units derived preparing, treating, packaging, trans- from 1,4-hexadiene. porting, or holding food, subject to the Hydrogenated butadiene/acrylonitrile co- provisions of this section. polymers (CAS Reg. No. 88254–10–8) pro- (a) The rubber articles are prepared duced when acrylonitrile/butadiene copoly- from natural and/or synthetic polymers mers are modified by hydrogenation of the and adjuvant substances as described olefinic unsaturation to leave either: (1) in paragraph (c) of this section. Not more than 10 percent trans olefinic unsaturation and no a, b-olefinic (b) The quantity of any substance unsaturation as determined by a method employed in the production of rubber entitled ‘‘Determination of Residual a, b- articles intended for repeated use shall Olefinic and Trans Olefinic Unsaturation not exceed the amount reasonably re- Levels in HNBR,’’ developed October 1, quired to accomplish the intended ef- 1991, by Polysar Rubber Corp., 1256 South fect in the rubber article and shall not Vidal St., Sarnia, Ontario, Canada N7T be intended to accomplish any effect in 7MI; or (2) 0.4 percent to 20 percent olefinic food. unsaturation and Mooney viscosities greater than 45 (ML 1 + 4 @ 100 °C), as deter- (c) Substances employed in the prep- mined by ASTM Standard Method D1646– aration of rubber articles include the 92, ‘‘Standard Test Method for Rubber— following, subject to any limitations Viscosity and Vulcanization Characteris- prescribed: tics (Mooney Viscometer),’’ which are both

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incorporated by reference in accordance Silicone (Si) elastomers containing methyl with 5 U.S.C. 552(a) and 1 CFR part 51. Cop- groups. ies of these methods may be obtained from Silicone (Psi) elastomers containing meth- the Division of Petition Control (HFS–215), yl and phenyl groups. Center for Food Safety and Applied Nutri- Silicone (Vsi) elastomers containing meth- tion, Food and Drug Administration, 5100 yl and vinyl groups. Paint Branch Pkwy., College Park, MD Silicone (Fsi) elastomers containing meth- 20740, or may be examined at the Center for yl and fluorine groups. Food Safety and Applied Nutrition’s Li- Silicone (PVsi) elastomers containing brary, 5100 Paint Branch Pkwy., College phenyl, methyl, and vinyl groups. Park, MD 20740, or at the Office of the Fed- Styrene-butadiene copolymer. eral Register, 800 North Capitol St. NW., Vinylidene fluoride-hexafluoropropylene co- suite 700, Washington, DC. A copy of ASTM polymers (minimum number average mo- Standard Method D1646–92 may also be ob- lecular weight 70,000 as determined by os- tained from the American Society for Test- motic pressure in methyl ethyl ketone). ing and Materials, 100 Barr Harbor Dr., Vinylidene fluoride-hexafluoropropylene- West Conshohocken, PA 19428–2959. tetrafluoroethylene copolymers (minimum Isobutylene-isoprene copolymer. number average molecular weight 100,000 Polyamide/polyether block copolymers (CAS as determined by osmotic pressure in Reg. No. 77402–38–1 prepared by reacting a methyl ethyl ketone). copolymer of omega-laurolactam and adipic acid with poly(tetramethylene ether gly- (ii) Vulcanization materials—(a) Vul- col). The polyamide and polyether compo- canizing agents. nents are reacted in ratios such that the 4,4′-Bis(aminocyclohexyl)methane carbamate polyamide component constitutes a min- for use only as cross-linking agent in the imum of 30 weight-percent of total polymer vulcanization of vinylidene units. The copolymers may be used in con- fluoridehexafluoropropylene copolymer tact with foods of Types I, II, III, IV, V, VI, VII, VIII, and IX identified in table 1 of and vinylidene fluoride- § 176.170(c) of this chapter at temperatures hexafluoropropylene-tetrafluoroethylene not to exceed 150 °F except that those co- copolymer elastomers identified under polymers prepared with less than 50 paragraph (c)(4)(i) of this section and lim- weight-percent of polyamide are limited to ited to use at levels not to exceed 2.4 per- use in contact with such foods at tempera- cent by weight of such copolymers. tures not to exceed 100 °F. Diisopropyl xanthogen polysulfide (a 1:2:1 Polybutadiene. mixture of O,O-di(1-methylethyl)trithio- Polyester elastomers derived from the reac- bis-thioformate, O,O-di(1- tion of dimethyl terephthalate, 1,4- methylethyl)tetrathio-bis-thioformate, butanediol, and a-hydro-omega- and O,O-di(1-methylethyl)pentathio-bis- hydroxypoly (oxytetramethylene). Addi- thioformate) for use as a cross linking tionally, trimethyl trimellitate may be agent in the vulcanization of natural rub- used as a reactant. The polyester ber, styrene-butadiene copolymer, acrylo- elastomers may be used only in contact nitrile-butadiene copolymer, and ethylene- with foods containing not more than 8 per- propylene terpolymers identified under cent alcohol and limited to use in contact paragraph (c)(4)(i) of this section and lim- with food at temperatures not exceeding ited to use at levels not to exceed 2.4 per- 150 °F. cent by weight of such copolymers. Polyisoprene. Hexamethylenediamine carbamate for use Polyurethane resins (CAS Reg. Nos. 37383–28– only as cross-linking agent in the vul- 1 or 9018–04–6) derived from the reaction of canization of vinylidene fluoride- diphenylmethane diisocyanate with 1,4- hexafluoropropylene copolymer and vinyli- butanediol and polytetramethylene ether dene fluoride-hexafluoropropylene-tetra- glycol. fluoroethylene copolymer elastomers iden- Polyurethane resins derived from reactions tified under paragraph (c)(4)(i) of this sec- of diphenylmethane diisocyanate with tion and limited to use at levels not to ex- adipic acid and 1,4-butanediol. ceed 1.5 percent by weight of such copoly- Rubber, natural. mers. Silicone basic polymer as described in ASTM Sulfur, ground. method D1418–81, ‘‘Standard Practice for (b) Accelerators (total not to exceed 1.5 Rubber and Rubber Latices—Nomen- percent by weight of rubber product). clature,’’ which is incorporated by reference. Copies may be obtained from the 2-Benzothiazyl-N,N-diethylthiocarbamyl-sul- American Society for Testing Materials, fide. 1916 Race St., Philadelphia, PA 19103, or Benzoyl peroxide. may be examined at the Office of the Fed- 1,3-Bis(2-benzothiazolylmercaptomethyl) eral Register, 800 North Capitol Street, urea. NW., suite 700, Washington, DC 20408. N-tert-Butyl-2-benzothiazole sulfenamide.

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Butyraldehyde-aniline resin (iodine number Zinc butyl xanathate. 670–705). Zinc dibenzyl dithiocarbamate. Carbon disulfide-1,1′-methylenedipiperidine Zinc dibutyldithiocarbamate. reaction product. Zinc diethyldithiocarbamate. Copper dimethyldithiocarbamate. Zinc 2-mercaptobenzothiazole. N-Cyclohexyl-2-benzothiazole sulfenamide. Ziram (zinc dimethyldithiocarbamate). Dibenzoyl-p-quinone dioxime. Dibenzylamine. (c) Retarders (total not to exceed 10 per- Diisopropyl xanthogen polysulfide (a 1:2:1 cent of weight of rubber product). mixture of O,O-di(1-methylethyl)trithio- Cyanoguanidine. bis-thioformate, O,O-di(1- Phthalic anhydride. methylethyl)tetrathio-bis-thioformate, Salicylic acid. and O,O-di(1-methylethyl)pentathio-bis- thioformate). (d) Activators (total not to exceed 5 per- Di(4-methylbenzoyl) peroxide (CAS Reg. No. cent by weight of rubber product except 895–85–2) for use only as a crosslinking magnesium oxide may be used at higher agent in silicone polymers and elastomers levels). identified under paragraph (c)(4)(i) of this section at levels not to exceed 1 percent by Diethylamine. weight of such polymers and elastomers Fatty acid amines, mixed. where the total of all accelerators does not Fatty acids. exceed 1.5 percent by weight of rubber Magnesium carbonate. product. Magnesium oxide, light and heavy. Di-tert-butyl peroxide. Oleic acid, dibutylamine salt Dibutyl xanthogen disulfide. (dibutylammonium oleate). 2,4-Dichlorobenzoyl peroxide. Stannous chloride. Dicumyl peroxide. Tall oil fatty acids. N,N-Dimethylcyclohexylamine salt of Tetrachloro-p-benzoquinone. dibutyldithiocarbamic acid. Triethanolamine. 2,6-Dimethylmorpholine thiobenzothiazol. Zinc salts of fatty acids. Dipentamethylenethiuram hexasulfide (CAS Reg. No. 971–15–3). (iii) Antioxidants and antiozonants Diphenylguanidine. (total not to exceed 5 percent by weight of Diphenylguanidine phthalate. rubber product). 1,3-Diphenyl-2-thiourea. 2,2′-Dithiobis[benzothiazole]. Aldol-a-naphthylamine. 4,4′-Dithiodimorpholine. Alkylated (C4 and/or C8) phenols. N,N′-Di-o-tolylguanidine. BHT (butylated hydroxytoluene). Di-o-tolylguanidine salt of 4-[[4,6-bis(octylthio)-s-triazin-2-yl]amino]- pyrocatecholborate. 2,6-di-tert-butylphenol (CAS Reg. No. 991– Ethylenediamine carbamate. 84–4) for use only as a stabilizer at levels Heptaldehyde-aniline resin (iodine number not to exceed 0.5 percent by weight of the 430–445). finished rubber product. Hexamethylenetetramine. Butylated reaction product of p-cresol and 2-Mercaptobenzothiazole. dicyclopentadiene as identified in 2-Mercaptothiazoline. § 178.2010(b) of this chapter. N-Oxydiethylene-benzothiazole-2- Butylated, styrenated cresols identified in sulfenamide. § 178.2010(b) of this chapter. Piperidinium pentamethylenedithiocarba- 4,4′-Butylidinebis(6-tert-butyl-m-cresol). mate. N-Cyclohexyl-N′-phenylphenylenediamine. Potassium pentamethylenedithiocarbamate. p,p′-Diaminodiphenylmethane. p-Quinone dioxime. 2,5-Di-tert-amylhydroquinone. Sodium dibutyldithiocarbamate. Diaryl-p-phenylenediamine, where the aryl Sodium dimethyldithiocarbamate. group may be phenyl, tolyl, or xylyl. Stannous oleate for use only as an accel- 2,6-Di-tert-butyl-p-phenylphenol. erator for silicone elastomers. 1,2-Dihydro-2,2,4-trimethyl-6- Tetrabutylthiuram monosulfide. dodecylquinoline. Tetraethylthiuram disulfide. 1,2-Dihydro-2,2,4-trimethyl-6- (1,1,4,4-Tetramethyltetramethylene)bis [tert- ethoxyquinoline. butyl peroxide]. 1,2-Dihydro-2,2,4-trimethyl-6- Tetramethylthiuram monosulfide. phenylquinoline. Thiram (tetramethylthiuram disulfide). 4,4′-Dimethoxydiphenylamine. Triallyl cyanurate. 4,6-Dinonyl-o-cresol. Triethylenetetramine. N,N′-Dioctyl-p-phenylenediamine. 1,3,5-Triethyl-hexahydro-s-triazine Diphenylamine-acetone resin. (triethyltrimethylenetriamine). Diphenylamine-acetone-formaldehyde resin. Triphenylguanidine. N,N′-Diphenylethylenediamine.

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N,N′-Disalicylalpropylenediamine. Dibutyl sebacate. N,N′-Di-o-tolylethylenediamine. Didecyl adipate. Hydroquinone monobenzyl ether. Didecyl phthalate. Isopropoxydiphenylamine. Diisodecyl adipate. N-Isopropyl-N′-phenyl-p-phenylenediamine. Diisodecyl phthalate. 2,2′-Methylenebis(6-tert-butyl-4-ethylphenol). Diisooctyl adipate. 2,2′-Methylenebis(4-methyl-6-tert-butyl- Diisooctyl sebacate. phenol). Dioctyl adipate. 2,2′-Methylenebis(4-methyl-6-nonylphenol). Dioctyl phthalate. 2,2′-Methylenebis(4-methyl-6-tert- Dioctyl sebacate. octylphenol). Dipentene resin. Monooctyl- and dioctyldiphenylamine. Diphenyl ketone. N,N′-Di-b-naphthyl-p-phenylenediamine. Fatty acids. Phenyl-a-naphthylamine. Fatty acids, hydrogenated. Phenyl-b-naphthylamine. Isooctyl ester of tall oil fatty acids. Phenyl-b-naphthylamine-acetone aromatic Lanolin. amine resin (average molecular weight 600; a-Methylstyrene-vinyltoluene copolymer nitrogen content 5.3 percent). resins (molar ratio 1 a-methylstyrene to 3 o- and p-Phenylphenol. vinyltoluene). Polybutylated (mixture) 4,4′- Mineral oil; (1) In rubber articles complying isopropylidenediphenol. with this section, not to exceed 30 percent Sodium pentachlorophenate. by weight; (2) Alone or in combination Styrenated cresols produced when 2 moles of with waxes, petroleum, total not to exceed styrene are made to react with 1 mole of a 45 percent by weight of rubber articles that mixture of phenol and o-, m-, and p-cresols contain at least 20 percent by weight of so that the final product has a Brookfield ethylene-propylene copolymer elastomer viscosity at 25 °C of 1400 to 1700 centipoises. complying with paragraph (c)(4)(i) of this Styrenated phenol. section, in contact with foods of Types I, 4,4′-Thiobis (6-tert-butyl-m-cresol). II, III, IV, VI, VII, VIII, and IX idenified in Toluene-2,4-diamine. table 1 of § 176.170(c) of this chapter. N-o-Tolyl-N′-phenyl-p-phenylenediamine. Montan wax. p(p-Tolylsufanilamide) diphenylamine. n-Octyl n-decyl adipate. Tri(mixed mono- and dinonylphenyl) n-Octyl n-decyl phthalate. phosphite. Petrolatum. Tri(nonylphenyl) phosphite-formaldehyde Petroleum hydrocarbon resin resins produced when 1 mole of (cyclopentadiene type), hydrogenated. tri(nonylphenyl) phosphite is made to Petroleum hydrocarbon resin (produced by react with 1.4 moles of formaldehyde or the homo- and copolymerization of dienes produced when 1 mole of nonylphenol is and olefins of the aliphatic, alicyclic, and made to react with 0.36 mole of formalde- monobenzenoid arylalkene types from dis- hyde and the reaction product is then fur- tillates of cracked petroleum stocks). ther reacted with 0.33 mole of phosphorus Petroleum hydrocarbon resin (produced by trichloride. The finished resins have a min- the catalytic polymerization and subse- imum viscosity of 20,000 centipoises at 25 quent hydrogenation of styrene, °C, as determined by LV–series Brookfield vinyltoluene, and indene types from dis- viscometer (or equivalent) using a No. 4 tillates of cracked petroleum stocks). spindle at 12 r.p.m., and have an organic Petroleum oil, sulfonated. phosphorus content of 4.05 to 4.15 percent Phenol-formaldehyde resin. by weight. Pine tar. Polybutene. (iv) Plasticizers (total not to exceed 30 Polystyrene. percent by weight of rubber product un- Propylene glycol. less otherwise specified). n-Propyl ester of tall oil fatty acids. Rapeseed oil vulcanized with rubber maker’s n-Amyl n-decyl phthalate. sulfur. Butylacetyl ricinoleate. Rosins and rosin derivatives identified in n-Butyl ester of tall oil fatty acids. § 175.105(c)(5) of this chapter. Butyl laurate. Soybean oil vulcanized with rubber maker’s Butyl oleate. sulfur. Butyl stearate. Styrene-acrylonitrile copolymer. Calcium stearate. Terpene resins. Castor oil. Triethylene glycol dicaprate. Coumarone-indene resins. Triethylene glycol dicaprylate. 2,2′-Dibenzamidodiphenyl disulfide. Waxes, petroleum. Dibenzyl adipate. Xylene (or toluene) alkylated with Dibutoxyethoxyethyl adipate. dicyclopentadiene. Dibutyl phthalate. Zinc 2-benzamidothiophenate.

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(v) Fillers. Diethyl xanthogen disulfide. 4-(Diiodomethylsulfonyl) toluene, Chemical Aluminum hydroxide. Abstracts Service Registry No. 20018–09–01, Aluminum silicate. for use as an antifungal preservative at Asbestos fiber, chrysotile or crocidolite. levels not to exceed 0.3 percent by weight Barium sulfate. of the sealants and caulking materials. Carbon black (channel process or furnace Dodecyl mercaptan isomers, single or mixed. combustion process; total carbon black not 2-Ethoxyethanol. to exceed 50 percent by weight of rubber Iodoform. product; furnace combustion black content p-Menthane hydroperoxide. not to exceed 10 percent by weight of rub- a-(p-Nonylphenyl)-omega-hydroxypoly (oxy- ber products intended for use in contact ethylene) mixture of dihydrogen phosphate with milk or edible oils). and monohydrogen phosphate esters, bar- Cork. ium salt; the nonyl group is a propylene Cotton (floc, fibers, fabric). trimer isomer and the poly (oxyethylene) Mica. content averages 9 moles; for use only as Nylon (floc, fibers, fabric). residual polymerization emulsifier at lev- Silica. els not to exceed 0.7 percent by weight of Titanium dioxide. ethylene-propylene-1,4-hexadiene copoly- Zinc carbonate. mers identified under paragraph (c)(4)(i) of Zinc sulfide. this section. (vi) Colorants. Colorants used in ac- 4,4′-Oxybis (benzenesulfonhydrazide) as cordance with § 178.3297 of this chapter. chemical blowing agent. (vii) Lubricants (total not to exceed 2 Phenothiazine. Potassium persulfate. percent by weight of rubber product). Sodium formaldehyde sulfoxylate. Polyethylene. Sodium polysulfide. Sodium stearate. Sodium nitrite. Sodium salt of ethylenediamine tetraacetic (viii) Emulsifiers. acid and glycine. Sodium sulfide. Fatty acid salts, sodium or potassium. Styrene monomer. Naphthalene sulfonic acid-formaldehyde con- Tall oil. densate, sodium salt. Thioxylenois as peptizing agents. Rosins and rosin-derivatives identified in Tridecyl mercaptan. § 175.105(c)(5) of this chapter. Zinc 4-tert-butylthiophenate as peptizing Sodium decylbenzenesulfonate agent. Sodium dodecylbenzenesulfonate Sodium lauryl sulfate. (d) Rubber articles intended for use Tall oil mixed soap (calcium, potassium, and with dry food are so formulated and sodium). cured under conditions of good manu- (ix) Miscellaneous (total not to exceed 5 facturing practice as to be suitable for percent by weight of rubber product). repeated use. (e) Rubber articles intended for re- Animal glue as described in § 178.3120 of this peated use in contact with aqueous chapter. Azodicarbonamide as chemical blowing food shall meet the following specifica- agent. tions: The food-contact surface of the 2-Anthraquinone sulfonic acid sodium salt rubber article in the finished form in for use only as polymerization inhibitor in which it is to contact food, when ex- chloroprene polymers and not to exceed tracted with distilled water at reflux 0.03 percent by weight of the chloroprene temperature, shall yield total extrac- polymers. tives not to exceed 20 milligrams per 1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634–33–5) for use as a biocide in uncured square inch during the first 7 hours of liquid rubber latex not to exceed 0.02 per- extraction, nor to exceed 1 milligram cent by weight of the latex solids, where per square inch during the succeeding 2 the total of all items listed in paragraph hours of extraction. (c)(4)(ix) of this section does not exceed 5 (f) Rubber articles intended for re- percent of the rubber product. peated use in contact with fatty foods n-Butyllithium for use only as polymeriza- shall meet the following specifications: tion catalyst for polybutadiene. The food-contact surface of the rubber 4-tert-Butyl-o-thiocresol as peptizing agent. tert-Butyl peracetate. article in the finished form in which it p-tert-Butylpyrocatechol. is to contact food, when extracted with Dialkyl (C8-C18 n-hexane at reflux temperature, shall Di- and triethanolamine. yield total extractives not to exceed

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175 milligrams per square inch during (c) In accordance with good manufac- the first 7 hours of extraction, nor to turing practice, finished articles con- exceed 4 milligrams per square inch taining the resins shall be thoroughly during the succeeding 2 hours of ex- cleansed prior to their first use in con- traction. tact with food. (g) In accordance with good manufacturing practice finished rubber articles § 177.2800 Textiles and textile fibers. intended for repeated use in contact Textiles and textile fibers may safely with food shall be thoroughly cleansed be used as articles or components of ar- prior to their first use in contact with ticles intended for use in producing, food. manufacturing, packing, processing, (h) The provisions of this section are preparing, treating, packaging, trans- not applicable to rubber nursing-bottle porting, or holding food, subject to the nipples. provisions of this section. (i) Acrylonitrile copolymers identi- (a) The textiles and textile fibers are fied in this section shall comply with prepared from one or more of the fibers the provisions of § 180.22 of this chap- identified in paragraph (d) of this sec- ter. tion and from certain other adjuvant substances required in the production [42 FR 14572, Mar. 15, 1977] of the textiles or textile fibers or added EDITORIAL NOTE: For FEDERAL REGISTER ci- to impart desired properties. tations affecting § 177.2600, see the List of (b) The quantity of any adjuvant sub- CFR Sections Affected, which appears in the stance employed in the production of Finding Aids section of the printed volume textiles or textile fibers does not ex- and on GPO Access. ceed the amount reasonably required to accomplish the intended physical or § 177.2710 Styrene-divinylbenzene resins, cross-linked. technical effect or any limitation further provided. Styrene-divinylbenzene cross-linked (c) Any substance employed in the copolymer resins may be safely used as production of textiles or textile fibers articles or components of articles in- that is the subject of a regulation in tended for repeated use in producing, parts 174, 175, 176, 177, 178 and § 179.45 of manufacturing, packing, processing, this chapter conforms with any speci- preparing, treating, packaging, trans- fication in such regulation. porting, or holding food, in accordance (d) Substances employed in the pro- with the following prescribed condi- duction of or added to textiles and tex- tions: tile fibers may include: (a) The resins are produced by the co- (1) Substances generally recognized polymerization of styrene with as safe in food. divinylbenzene. (2) Substances subject to prior sanc- (b) The resins meet the extractives tion or approval for use in textiles and limitations prescribed in this para- textile fibers and used in accordance graph: with such sanction or approval. (1) The resins to be tested are ground (3) Substances generally recognized or cut into small particles that will as safe for use in cotton and cotton fab- pass through a U.S. standard sieve No. rics used in dry-food packaging. 3 and that will be held on a U.S. stand- (4) Substances that by regulation in ard sieve No. 20. this part may safely be used in the pro- (2) A 100-gram sample of the resins, duction of or as a component of tex- when extracted with 100 milliliters of tiles or textile fibers and subject to ethyl acetate at reflux temperature for provisions of such regulation. 1 hour, yields total extractives not to (5) Substances identified in this para- exceed 1 percent by weight of the res- graph (d)(5), subject to such limitations ins. as are provided:

List of substances Limitations

(i) Fibers: Cotton.

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List of substances Limitations

Polyethylene terephthalate complying in composition with For use only in the manufacture of items for repeated use. the provisions of § 177.1630(e)(4)(ii). Rayon. (ii) Adjuvant substances: Aluminum stearate. Borax ...... For use as preservative only. Butyl-acetyl ricinoleate. Colorants used in accordance with § 178.3297 of this chapter.. Di-tert-butyl hydroquinone. Dimethylpolysiloxane. Ethylenediaminetetraacetic acid, sodium salt. 4-Ethyl-4-hexadecyl morpholinium ethyl sulfate ...... For use only as a lubricant in the manufacture of polyethylene terephthalate fibers specified in paragraph (d)(5)(i) of this section at a level not to exceed 0.03 percent by weight of the finished fibers. Eugenol. Fats, oils, fatty acids, and fatty alcohols derived from castor, coconut, cottonseed, fish, mustardseed, palm, peanut, rapeseed, ricebran, soybean, sperm, and tall oils and tallow. Fats, oils, fatty acids, and fatty alcohols described in the preceding item reacted with one or more of the following substances: n-Butyl and isobutyl alcohol. Diethylene glycol. Diethanolamine. Glycerol. Hexylene glycol (2-methyl-2,4-pentanediol). Hydrogen. Isopropyl alcohol. Methyl alcohol. Oxygen. Polyethylene glycol (molecular weight 400–3,000). Potassium hydroxide. Propylene glycol. Sodium hydroxide. Sulfuric acid. Formaldehyde ...... For use as preservative only. Glyceryl mono-12-hydroxystearate. 2-(9-Heptadecenyl)-1-[2-(10-octadecenamido)ethyl-2- imidazolinium ethyl sulfate. Hexylene glycol (2-methyl,-2,4-pentanediol). Isobutyl alcohol. Isopropyl alcohol. Kerosene. Methyl ester of sulfated ricebran oil. Mineral oil ...... For use only at a level not to exceed 0.15 percent by weight of finished fibers. Mono- and diisopropylated m- and p-cresols (isothymol derivative). N-Oleyl, N′-acetyl, N′-b-hydroxy-ethylenediamine. Petrolatum. Petroleum sulfonate. Pine oil. Polybutene, hydrogenated; complying with the identity prescribed under 21 CFR 178.3740(b) of this chapter. Polyethylene, oxidized (air blown). Polyvinyl acetate. Polyvinyl alcohol. Potassium soap of a saponified sulfated castor oil. Sodium bis(2,6-dimethylheptyl-4) sulfosuccinate. Sodium dioctyl sulfosuccinate. Sodium dodecyl benzenesulfonate. Sodium fluoride ...... For use as preservative only. Sodium hydrosulfite. Sodium hypochlorite. Sodium lauryl sulfate. Sodium 2-mercaptobenzothiazole ...... Do. Sodium pentachlorophenate ...... Do. Styrene-butadiene copolymer. Sulfated butyl, isobutyl and propyl oleate. Tallow. Tallow, sulfonated. Titanium dioxide. Triethanolamine.

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List of substances Limitations

Ultramarine blue. Waxes, petroleum. Zinc hydrosulfite.

(e) Textile and textile fibers are used during the commercial processing of as articles or components of articles bulk quantities of food. that contact dry food only. (d) Ultra-filtration membranes shall (f) The provisions of this section are be maintained in a sanitary manner in not applicable to jute fibers used as accordance with good manufacturing prescribed by § 178.3620(d)(2) of this practice so as to prevent potential mi- chapter. crobial adulteration of the food. [42 FR 14572, Mar. 15, 1977, as amended at 46 (e) Ultrafiltration membranes identi- FR 37042, July 17, 1981; 49 FR 4372, Feb. 6, fied in paragraph (a)(4) may be used to 1984; 49 FR 5748, Feb. 15, 1984; 56 FR 42933, filter aqueous or acidic foods con- Aug. 30, 1991] taining up to 13 percent of alcohol at § 177.2910 Ultra-filtration membranes. temperatures not to exceed 21 °C (70 ° Ultra-filtration membranes identi- F). fied in paragraphs (a)(1), (a)(2), (a)(3), (f) To assure safe use of the ultra-fil- and (a)(4) of this section may be safely tration membranes, the label or label- used in the processing of food, under ing shall include adequate directions the following prescribed conditions; for a pre-use treatment, consisting of (a)(1) Ultra-filtration membranes conditioning and washing with a min- that consist of paper impregnated with imum of 8 gallons of potable water cured phenol-formaldehyde resin, prior to their first use in contact with which is used as a support and is coat- food. ed with a vinyl chloride-acrylonitrile (g) Acrylonitrile copolymers identi- copolymer. fied in this section shall comply with (2) Ultra-filtration membranes that the provisions of § 180.22 of this chap- consist of a sintered carbon support ter. that is coated with zirconium oxide (CAS Reg. No. 1314–23–4) containing up [42 FR 14572, Mar. 15, 1977, as amended at 53 to 12 percent yttrium oxide (CAS Reg. FR 17925, May 19, 1988; 58 FR 48599, Sept. 17, No. 1314–36–9). 1993; 60 FR 54426, Oct. 24, 1995] (3) Ultra-filtration membranes that consist of an aluminum oxide support PART 178—INDIRECT FOOD ADDI- that is coated with zirconium oxide TIVES: ADJUVANTS, PRODUCTION (CAS Reg. No. 1314–23–4) containing up to 5 percent yttrium oxide (CAS Reg. AIDS, AND SANITIZERS No. 1314–36–9). (4) Ultrafiltration membranes that Subpart A [Reserved] consist of a microporous Subpart B—Substances Utilized To Control poly(vinylidene fluoride) membrane the Growth of Microorganisms with a hydrophilic surface modifier consisting of hydroxypropyl acrylate/ Sec. tetraethylene glycol diacrylate copoly- 178.1005 Hydrogen peroxide solution. mer. 178.1010 Sanitizing solutions. (b) Any substance employed in the production of ultra-filtration mem- Subpart C—Antioxidants and Stabilizers branes that is the subject of a regulation in parts 174, 175, 176, 177, 178 and 178.2010 Antioxidants and/or stabilizers for § 179.45 of this chapter conforms with polymers. the specifications of such regulation. 178.2550 4-Hydroxymethyl-2,6-di-tert-butyl- (c) Ultra-filtration membranes are phenol. used in the physical separation of dis- 178.2650 Organotin stabilizers in vinyl chlo- solved or colloidally suspended varying ride plastics. molecular size components of liquids

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Subpart D—Certain Adjuvants and EDITORIAL NOTE: Nomenclature changes to Production Aids part 178 appear at 61 FR 14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, 178.3010 Adjuvant substances used in the 2001, and 68 FR 15355, Mar. 31, 2003. manufacture of foamed plastics. 178.3120 Animal glue. 178.3125 Anticorrosive agents. Subpart A [Reserved] 178.3130 Antistatic and/or antifogging agents in food-packaging materials. Subpart B—Substances Utilized To 178.3280 Castor oil, hydrogenated. 178.3290 Chromic chloride complexes. Control the Growth of Micro- 178.3295 Clarifying agents for polymers. organisms 178.3297 Colorants for polymers. 178.3300 Corrosion inhibitors used for steel § 178.1005 Hydrogen peroxide solution. or tinplate. 178.3400 Emulsifiers and/or surface-active Hydrogen peroxide solution identi- agents. fied in this section may be safely used 178.3450 Esters of stearic and palmitic acids. to sterilize polymeric food-contact sur- 178.3480 Fatty alcohols, synthetic. faces identified in paragraph (e)(1) of 178.3500 Glycerin, synthetic. this section. 178.3505 Glyceryl tri-(12-acetoxystearate). (a) Identity. For the purpose of this 178.3520 Industrial starch-modified. section, hydrogen peroxide solution is 178.3530 Isoparaffinic petroleum hydrocarbons, synthetic. an aqueous solution containing not 178.3570 Lubricants with incidental food more than 35 percent hydrogen per- contact. oxide (CAS Reg. No. 7722–84–1) by 178.3600 Methyl glucoside-coconut oil ester. weight, meeting the specifications pre- 178.3610 a-Methylstyrene-vinyltoluene res- scribed in paragraph (c) of this section. ins, hydrogenated. (b) Optional adjuvant substances. Hy- 178.3620 Mineral oil. drogen peroxide solution identified in 178.3650 Odorless light petroleum hydrocarbons. paragraph (a) of this section may con- 178.3690 Pentaerythritol adipate–stearate. tain substances generally recognized as 178.3700 Petrolatum. safe in or on food, substances generally 178.3710 Petroleum wax. recognized for their intended use in 178.3720 Petroleum wax, synthetic. food packaging, substances used in ac- 178.3725 Pigment dispersants. cordance with a prior sanction or ap- 178.3730 Piperonyl butoxide and pyrethrins proval, and substances permitted by as components of bags. 178.3740 Plasticizers in polymeric sub- applicable regulations in parts 174 stances. through 179 of this chapter. 178.3750 Polyethylene glycol (mean molec- (c) Specifications. Hydrogen peroxide ular weight 200–9,500). solution shall meet the specifications 178.3760 Polyethylene glycol (400) of the ‘‘Food Chemicals Codex,’’ 3d Ed. monolaurate. (1981), pp. 146–147, which is incorporated 178.3770 Polyhydric alcohol esters of by reference (copies may be obtained oxidatively refined (Gersthofen process) montan wax acids. from the National Academy Press, 2101 178.3780 Polyhydric alcohol esters of long Constitution Ave. NW., Washington, chain monobasic acids. DC 20418, or may be examined at the 178.3790 Polymer modifiers in semirigid and Office of the Federal Register, 800 rigid vinyl chloride plastics. North Capitol Street, NW., suite 700, 178.3800 Preservatives for wood. Washington, DC 20408), and the United 178.3850 Reinforced wax. States Pharmacopeia XX (1980), except 178.3860 Release agents. 178.3870 Rosins and rosin derivatives. that hydrogen peroxide may exceed the 178.3900 Sodium pentachlorophenate. concentration specified therein. 178.3910 Surface lubricants used in the man- (d) Limitations. No use of hydrogen ufacture of metallic articles. peroxide solution in the sterilization of 178.3930 Terpene resins. food packaging material shall be con- 178.3940 Tetraethylene glycol di-(2-ethyl- sidered to be in compliance if more hexoate). than 0.5 part per million of hydrogen 178.3950 Tetrahydrofuran. peroxide can be determined in distilled AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. water packaged under production con- SOURCE: 42 FR 14609, Mar. 15, 1977, unless ditions (assay to be performed imme- otherwise noted. diately after packaging).

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(e) Conditions of use. (1) Hydrogen per- § 178.1010 Sanitizing solutions. oxide solution identified in and com- Sanitizing solutions may be safely plying with the specifications in this used on food-processing equipment and section may be used by itself or in utensils, and on other food-contact ar- combination with other processes to ticles as specified in this section, with- treat food-contact surfaces to attain in the following prescribed conditions: commercial sterility at least equiva- (a) Such sanitizing solutions are lent to that attainable by thermal used, followed by adequate draining, processing for metal containers as pro- before contact with food. vided for in part 113 of this chapter. (b) The solutions consist of one of the Food-contact surfaces include the fol- following, to which may be added com- lowing: ponents generally recognized as safe Substances Limitations and components which are permitted by prior sanction or approval. Ethylene-acrylic acid Complying with § 177.1310 of this (1) An aqueous solution containing copolymers. chapter. Ethylene-carbon mon- Complying with § 177.1312 of this potassium, sodium, or calcium hypo- oxide copolymers. chapter. chlorite, with or without the bromides Ethylene-methyl acry- Complying with § 177.1340 of this of potassium, sodium, or calcium. late copolymer resins. chapter. Ethylene-vinyl acetate Complying with § 177.1350 of this (2) An aqueous solution containing copolymers. chapter. dichloroisocyanuric acid, Ionomeric resins ...... Complying with § 177.1330 of this trichloroisocyanuric acid, or the so- chapter. dium or potassium salts of these acids, Isobutylene polymers... Complying with § 177.1420 (a)(1) and (a)(2) of this chapter. with or without the bromides of potas- Olefin polymers ...... Complying with § 177.1520 of this sium, sodium, or calcium. chapter. (3) An aqueous solution containing Polycarbonate resins ... Complying with § 177.1580 of this chapter. potassium iodide, sodium p- Polyethylene- Complying with § 177.1630 of this toluenesulfonchloroamide, and sodium terephthalate poly- chapter (excluding polymers de- lauryl sulfate. mers. scribed in § 177.1630(c)) of this (4) An aqueous solution containing chapter. Poly-l-butene resins Complying with § 177.1570 of this iodine, butoxy monoether of mixed and butene/ethylene chapter. (ethylene-propylene) polyalkylene gly- copolymers. col having a cloudpoint of 90°–100 °C in Polystryrene and rub- Complying with § 177.1640 of this ber-modified poly- chapter. 0.5 percent aqueous solution and an av- styrene polymers. erage molecular weight of 3,300, and Vinylidene chloride/ Complying with § 177.1990 of this ethylene glycol monobutyl ether. Addi- methyl acrylate co- chapter. tionally, the aqueous solution may polymers. contain diethylene glycol monoethyl (2) The packaging materials identi- ether as an optional ingredient. fied in paragraph (e)(1) of this section (5) An aqueous solution containing may be used for packaging all commer- elemental iodine, hydriodic acid, a-(p- cially sterile foods except that the nonylphenyl)-omega-hydroxypoly-(oxy- olefin polymers may be used in articles ethylene) (complying with the identity for packaging foods only of the types prescribed in § 178.3400(c) and having a identified in § 176.170(c) of this chapter, maximum average molecular weight of table 1, under Categories I, II, III, IV– 748) and/or polyoxyethylene- B, V, and VI. polyoxypropylene block polymers (hav- (3) Processed foods packaged in the ing a minimum average molecular materials identified in paragraph (e)(1) weight of 1,900). Additionally, the aque- of this section shall conform with parts ous solution may contain isopropyl al- 108, 110, 113, and 114 of this chapter as cohol as an optional ingredient. applicable. (6) An aqueous solution containing elemental iodine, sodium iodide, so- [46 FR 2342, Jan. 9, 1981, as amended at 49 FR dium dioctylsulfosuccinate, and 10111, Mar. 19, 1984; 49 FR 32345, Aug. 14, 1984; polyoxyethylene-polyoxypropylene 49 FR 37747, Sept. 26, 1984; 51 FR 45881, Dec. 23, 1986; 52 FR 26146, July 13, 1987; 53 FR 47186, block polymers (having a minimum av- Nov. 22, 1988; 54 FR 5604, Feb. 6, 1989; 54 FR erage molecular weight of 1,900). 13167, Mar. 31, 1989; 54 FR 6365 Feb. 9, 1989; 55 (7) An aqueous solution containing FR 47055, Nov. 9, 1990; 57 FR 32423, July 22, dodecylbenzenesulfonic acid and either 1992] isopropyl alcohol or polyoxyethylene-

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polyoxypropylene block polymers (hav- 2,000 and 27 to 31 moles of ing a minimum average molecular polyoxypropylene). In addition to use weight of 2,800). In addition to use on on food-processing equipment and food-processing equipment and uten- utensils, this solution may be used on sils, this solution may be used on glass glass bottles and other glass containers bottles and other glass containers in- intended for holding milk. All equip- tended for holding milk. ment, utensils, glass bottles, and other (8) An aqueous solution containing glass containers treated with this sani- elemental iodine, butoxy monoether of tizing solution shall have a drainage mixed (ethylene-propylene) period of 15 minutes prior to use in polyalkylene glycol having a minimum contact with food. average molecular weight of 2,400 and (13) An aqueous solution containing a-lauroyl-omega-hydroxypoly (oxy- elemental iodine and alkyl (C12-C15) ethylene) with an average 8–9 moles of monoether of mixed (ethylene-pro- ethylene oxide and an average molec- pylene) polyalkylene glycol, having a ular weight of 400. In addition to use on cloud-point of 70°–77 °C in 1 percent food-processing equipment and uten- aqueous solution and an average mo- sils, this solution may be used on bev- lecular weight of 807. erage containers, including milk con- (14) An aqueous solution containing tainers or equipment. Rinse water iodine, butoxy monoether of mixed treated with this solution can be recir- (ethylene-propylene) polyalkylene gly- culated as a preliminary rinse. It is not col, having a cloud-point of 90°–100 °C to be used as final rinse. in 0.5 percent aqueous solution and an (9) An aqueous solution containing n- average molecular weight of 3,300, and alkyl (C12-C18) benzyldimethylam- polyoxyethylene-polyoxypropylene monium chloride compounds having block polymers (having a minimum av- average molecular weights of 351 to 380. erage molecular weight of 2,000). The alkyl groups consist principally of (15) An aqueous solution containing groups with 12 to 16 carbon atoms and lithium hypochlorite. contain not more than 1 percent each (16) An aqueous solution containing of groups with 8 and 10 carbon atoms. equal amounts of n-alkyl (C12-C18) ben- Additionally, the aqueous solution may zyl dimethyl ammonium chloride and contain either ethyl alcohol or iso- n-alkyl (C12-C14) dimethyl ethylbenzyl propyl alcohol as an optional ingre- ammonium chloride (having average dient. molecular weights of 377 to 384), with (10) An aqueous solution containing the optional adjuvant substances trichloromelamine and either sodium tetrasodium ethylenediaminetetra- lauryl sulfate or dodecyl- acetate and/or alpha-(p-nonylphenol)- benzenesulfonic acid. In addition to use omega-hydroxy poly (oxyethylene) hav- on food-processing equipment and ing an average poly- (oxyethylene) con- utensils and other food-contact arti- tent of 11 moles. Alpha-hydro-omega- cles, this solution may be used on bev- hydroxypoly-(oxyethylene) erage containers except milk con- poly(oxypropoylene) (15 to 18 mole tainers or equipment. minimum) poly (oxyethylene) block co- (11) An aqueous solution containing polymer, having a minimum molecular equal amounts of n-alkyl (C12-C18) ben- weight of 1,900 (CAS Registry No. 9003– zyl dimethyl ammonium chloride and 11–6) may be used in lieu of alpha- (p- n-alkyl (C12-C18) dimethyl ethylbenzyl nonylphenol)-omega-hydroxy- ammonium chloride (having an average poly(oxyethylene) having an average molecular weight of 384). In addition to poly(oxyethylene) content of 11 moles. use on food-processing equipment and In addition to use on food-processing utensils, this solution may be used on equipment and utensils, this solution food-contact surfaces in public eating may be used on food-contact surfaces places. in public eating places. (12) An aqueous solution containing (17) An aqueous solution containing the sodium salt of sulfonated oleic di-n-alkyl(C8-C10)dimethyl ammonium acid, polyoxyethylene- chlorides having average molecular polyoxypropylene block polymers (hav- weights of 332–361 and either ethyl al- ing an average molecular weight of cohol or isopropyl alcohol. In addition

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to use on food-processing equipment oxide, and alpha-alkyl(C12-C15)-omega- and utensils, this solution may be used hydroxy[poly(oxyethylene) on food-contact surfaces in public eat- poly(oxypropylene)] (having an average ing places. molecular weight of 965). (18) An aqueous solution containing (25) An aqueous solution containing n-alkyl(C12-C18) benzyldimethylammo- elemental iodine (CAS Reg. No. 7553–56– nium chloride, sodium metaborate, 2), potassium iodide (CAS Reg. No. alpha-terpineol and alpha[p-(1,1,3,3- 7681–11–0), and isopropanol (CAS Reg. tetramethylbutyl)phenyl] -omega-hy- No. 67–63–0). In addition to use on food droxy-poly (oxyethylene) produced processing equipment and utensils, this with one mole of the phenol and 4 to 14 solution may be used on beverage con- moles ethylene oxide. tainers, including milk containers and (19) An aqueous solution containing equipment and on food-contact sur- sodium dichloroisocyanurate and faces in public eating places. tetrasodium ethylenediaminetetra- (26) [Reserved] acetate. In addition to use on food- (27) An aqueous solution containing processing equipment and utensils, this decanoic acid (CAS Reg. No. 334–48–5), solution may be used on food-contact octanoic acid (CAS Reg. No. 124–07–2), surfaces in public eating places. and sodium 1-octanesulfonate (CAS (20) An aqueous solution containing Reg. No. 5324–84–5). Additionally, the ortho-phenylphenol, ortho-benzyl-para- aqueous solution may contain iso- chlorophenol, para- propyl alcohol (CAS Reg. No. 67–63–0) tertiaryamylphenol, sodium -alpha- as an optional ingredient. alkyl(C12-C15)-omega-hydroxypoly (oxyethylene) sulfate with the (28) An aqueous solution containing poly(oxyethylene) content averaging sulfonated 9-octadecenoic acid (CAS one mole, potassium salts of coconut Reg. No. 68988–76–1) and sodium oil fatty acids, and isopropyl alcohol or xylenesulfonate (CAS Reg. No. 1300–72– hexylene glycol. 7). (21) An aqueous solution containing (29) An aqueous solution containing sodium dodecylbenzenesulfonate. In ad- dodecyldiphenyloxidedisulfonic acid dition to use on food-processing equip- (CAS Reg. No. 30260–73–2), sulfonated ment and utensils, this solution may tall oil fatty acid (CAS Reg. No. 68309– be used on glass bottles and other glass 27–3), and neo-decanoic acid (CAS Reg. containers intended for holding milk. No. 26896–20–8). In addition to use on (22) An aqueous solution containing food-processing equipment and utensils, this solution may be used on glass (1) di-n-alkyl(C8-C10) dimethylammonium chloride com- bottles and other glass containers in- pounds having average molecular tended for holding milk. weights of 332–361, (2) n-alkyl (C12-C18) (30) An aqueous solution containing benzyldimethylammonium chloride hydrogen peroxide (CAS Reg. No. 7722– compounds having average molecular 84–1), peracetic acid (CAS Reg. No. 79– weights of 351–380 and consisting prin- 21–0), acetic acid (CAS Reg. No. 64–19– cipally of alkyl groups with 12 to 16 7), and 1-hydroxyethylidene-1,1- carbon atoms with or without not over diphosphonic acid (CAS Reg. No. 2809– 1 percent each of groups with 8 and 10 21–4). carbon atoms, and (3) ethyl alcohol. (31) An aqueous solution containing The ratio of compound (1) to compound elemental iodine, alpha-alkyl(C10-C14)- (2) is 60 to 40. omega-hydroxypoly(oxyethylene)poly- (23) An aqueous solution containing (oxypropylene) of average molecular n-alkyl (C12-C16) benzyl- weight between 768 and 837, and alpha- dimethylammonium chloride and alkyl(C12-C18)-omega- didecyldimethylammonium chloride. hydroxypoly(oxyethylene) (24) An aqueous solution containing poly(oxypropylene) of average molec- elemental iodine (CAS Reg. No. 7553–56– ular weight between 950 and 1,120. In 2), alpha-[p-(1,1,3,3-tetramethylbutyl)- addition to use on food-processing phenyl]-omega-hydroxypoly-(oxy- equipment and utensils, this solution ethylene) produced with one mole of may be used on food-contact surfaces the phenol and 4 to 14 moles ethylene in public eating places.

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(32) An aqueous solution containing 2) and a mixture of the sodium salt of (i) di-n-alkyl(C8-C10)dimethyl- ammo- naphthalenesulfonic acid (CAS Reg. nium chloride compounds having aver- No. 1321–69–3); the methyl, dimethyl, age molecular weights of 332 to 361, (ii) and trimethyl dervatives of the sodium n-alkyl(C12-C18)benzyldimethylammo- salt of naphthalenesulfonic acid; and a nium chloride compounds having aver- mixture of the sodium salt of age molecular weights of 351 to 380 and naphthalenesulfonic acid, and the consisting principally of alkyl groups methyl, dimethyl, and trimethyl de- with 12 to 16 carbon atoms with no rivatives of the sodium salt of more than 1 percent of groups with 8 naphthalenesulfonic acid alkylated at 3 and 10, (iii) ethyl alcohol, and (iv) percent by weight with C6-C9 linear alpha-(p-nonylphenyl)-omega- olefins, as components of a sanitizing hydroxypoly(oxyethylene) produced by solution to be used on food-processing the condensation of 1 mole of p- equipment and utensils. The methyl nonylphenol with 9 to 12 moles of and dimethyl substituted derivatives ethylene oxide. The ratio of compound (described within this paragraph (i) to compound (ii) is 3 to 2. (b)(35)) constitute no less than 70 per- (33) An aqueous solution containing cent by weight of the mixture of (i) di-n-alkyl-(C8-C10)- naphthalenesulfonates. dimethylammonium chloride com- (36) The sanitizing solution contains pounds having average molecular decanoic acid (CAS Reg. No. 334–48–5); weights of 332 to 361; (ii) n-alkyl(C12- octanoic acid (CAS Reg. No. 124–07–2); C18) -benzyldimethylammonium chlo- lactic acid (CAS Reg. No. 050–21–5); ride compounds having molecular phosphoric acid (CAS Reg. No. 7664–38– weights of 351 to 380 and consisting 2); a mixture of 1-octanesulfonic acid principally of alkyl groups with 12 to 16 (CAS Reg. No. 3944–72–7), and 1- carbon atoms with no more than 1 per- octanesulfonic-2-sulfinic acid (CAS cent of the groups with 8 to 10; and (iii) Reg. No. 113652–56–5) or 1,2- tetrasodium ethylenediamine octanedisulfonic acid (CAS Reg. No. tetraacetate. Additionally, the aqueous 1934210); the condensate of four moles solution contains either alpha-(p- of nonylphenyl)-omega-hydroxypoly-(oxy- poly(oxyethylene)poly(oxypropylene) ethylene) or alpha-alkyl(C11-C15)-omega- block copolymers with one mole of hydroxypoly-(oxyethylene), each pro- ethylenediamine (CAS Reg. No. 11111– duced with 9 to 13 moles of ethylene 34–5); and the optional ingredient oxide. The ratio of compound (i) to FD&C Yellow No. 5 (CAS Reg. No. compound (ii) is 3 to 2. 001934210). In addition to use on food- (34) An aqueous solution of an equi- processing equipment and utensils, this librium mixture of oxychloro species solution may be used on dairy-proc- (predominantly chlorite, chlorate, and essing equipment. chlorine dioxide) generated either (i) (37) The sanitizing solution contains by directly metering a concentrated sodium hypochlorite (CAS Reg. No. chlorine dioxide solution, prepared just 7681–52–9), trisodium phosphate (CAS prior to use, into potable water to pro- Reg. No. 7601–54–9), sodium lauryl sul- vide the concentration of available fate (CAS Reg. No. 151–21–3), and potas- chlorine dioxide stated in paragraph sium permanganate (CAS Reg. No. (c)(29) of this section, or (ii) by acidifi- 7722–64–7). Magnesium oxide (CAS Reg. cation of an aqueous alkaline solution No. 1309–48–4) and potassium bromide of oxychloro species (predominantly (CAS Reg. No. 7758–02–3) may be added chlorite and chlorate) followed by dilu- as optional ingredients to this sani- tion with potable water to provide the tizing solution. In addition to use on concentration of available chlorine di- food-processing equipment and uten- oxide described in paragraph (c)(29) of sils, this solution may be used on food- this section. contact surfaces in public eating (35) An aqueous solution containing places. decanoic acid (CAS Reg. No. 334–48–5), (38) An aqueous solution containing octanoic acid (CAS Reg. No. 124–07–2), hydrogen peroxide (CAS Reg. No. 7722– lactic acid (CAS Reg. No. 050–21–5), 84–1); peroxyacetic acid (CAS Reg. No. phosphoric acid (CAS Reg. No. 7664–38– 79–21–0); acetic acid (CAS Reg. No. 64–

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19–7); sulfuric acid (CAS Reg. No. 7664– phosphoric acid (CAS Reg. No. 7664–38– 93–9); and 2,6-pyridinedicarboxylic acid 2), propionic acid (CAS Reg No. 79–09– (CAS Reg. No. 499–83–2). In addition to 04), and sodium 1-octanesulfonate (CAS use on food-processing equipment and Reg. No. 5324–84–5). Sulfuric acid (CAS utensils, this solution may be used on Reg. No. 7664–93–9) may be added as an dairy-processing equipment. optional ingredient. In addition to use (39) An aqueous solution containing on food-processing equipment and phosphoric acid (CAS Reg. No. 7664–38– utensils, this solution may be used on 2); octenyl succinic acid (CAS Reg. No. dairy-processing equipment. 28805–58–5); N,N-dimethyloctanamine (43) An aqueous solution of iodine (CAS Reg. No. 7378–99–6); and a mixture and hypochlorous acid generated by of n-carboxylic acids (C6-C12, consisting the dilution of an aqueous acidic (21.5 of not less than 56 percent octanoic percent nitric acid) solution of iodine acid and not less than 40 percent deca- monochloride. In addition to use on noic acid). This solution may be used food-processing equipment and uten- on food-processing equipment and sils, this solution may be used on utensils, including dairy-processing dairy-processing equipment. equipment. (44) An aqueous solution of citric (40) An aqueous solution prepared by acid, disodium ethylenediaminetetra- combining elemental iodine (CAS Reg. acetate, sodium lauryl sulfate, and No. 7553–56–2); hydriodic acid (CAS Reg. monosodium phosphate. In addition to No. 10034–85–2); sodium N-cyclohexyl-N- use on food-processing equipment and palmitoyl taurate (CAS Reg. No. 132– utensils, this solution may be used on 43–4); chloroacetic acid, sodium salt re- dairy-processing equipment. action products with 4,5-dihydro-2- (45) An aqueous solution of hydrogen undecyl-1H-imidazole-1-ethanol and so- peroxide, acetic acid, peroxyacetic dium hydroxide (CAS Reg. No. 68608–66– acid, octanoic acid, peroxyoctanoic 2); dodecylbenzene sulfonic acid (CAS acid, sodium 1-octanesulfonate, and 1- Reg. No. 27176–87–0); phosphoric acid hydroxyethylidene-1,1-diphosphonic (CAS Reg. No. 7664–38–2); isopropyl alcohol (CAS Reg. No. 67–63–0); and cal- acid. In addition to use on food-proc- cium chloride (CAS Reg. No. 10043–52– essing equipment and utensils, this so- 4). In addition to use on food-proc- lution may be used on food-contact essing equipment and utensils, this so- surfaces in public eating places, sub- lution may be used on dairy-processing ject to the limitations in paragraph equipment. (c)(39) of this section. (41) An aqueous solution containing (46) An aqueous solution of chlorine dioxide and related oxychloro species n-alkyl(C12- generated by acidification of an aque- C16)benzyldimethylammonium chloride, having average molecular weights ous solution of sodium chlorite with a ranging from 351 to 380 wherein the solution of sodium gluconate, citric alkyl groups contain principally 12 to acid, phosphoric acid, and sodium 16 carbons and not more than 1 percent mono- and each of the groups with 8 and 10 carbon didodecylphenoxybenzenedisulfonate. atoms; ammonium chloride (CAS Reg. In addition to use on food-processing No. 12125–02–9); calcium stearate (CAS equipment and utensils, this solution Reg. No. 1592–23–0); sodium bicarbonate may be used on dairy-processing equip- (CAS Reg. No. 144–55–8); starch or ment. dextrin, or both starch and dextrin (c) The solutions identified in para- (CAS Reg. No. 9004–53–9); and the op- graph (b) of this section will not exceed tional ingredient methylene blue (CAS the following concentrations: Reg. No. 61–73–4). In addition to use on (1) Solutions identified in paragraph food-processing equipment and uten- (b)(1) of this section will provide not sils, this solution may be used on food- more than 200 parts per million of contact surfaces in public eating available halogen determined as avail- places. able chlorine. (42) An aqueous solution containing (2) Solutions identified in paragraph decanoic acid (CAS Reg. No. 334–48–5), (b)(2) of this section will provide not nonanoic acid (CAS Reg. No. 112–05–0), more than 100 parts per million of

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available halogen determined as avail- available chlorine and not more than 30 able chlorine. ppm lithium. (3) Solution identified in paragraph (11) Solutions identified in paragraph (b)(3) of this section will provide not (b)(16) of this section shall provide not more than 25 parts per million of ti- more than 200 parts per million of ac- tratable iodine. The solutions will con- tive quaternary compound. tain the components potassium iodide, (12) Solutions identified in paragraph sodium p-toluenesulfonchloramide and (b)(17) of this section shall provide, sodium lauryl sulfate at a level not in when ready to use, a level of 150 parts excess of the minimum required to per million of the active quaternary produce their intended functional ef- compound. fect. (13) Solutions identified in paragraph (4) Solutions identified in paragraph (b)(18) of this section shall provide not (b)(4), (5), (6), (8), (13), and (14) of this more than 200 parts per million of ac- section will contain iodine to provide tive quaternary compound and not not more than 25 parts per million of more than 66 parts per million of titratable iodine. The adjuvants used alpha[p-(1,1,3,3-tetramethylbutyl) with the iodine will not be in excess of phenyl]-omega-hydroxypoly (oxy- the minimum amounts required to ac- ethylene). complish the intended technical effect. (14) Solutions identified in paragraph (b)(19) of this section shall provide, (5) Solutions identified in paragraph when ready to use, a level of 100 parts (b)(7) of this section will provide not per million of available chlorine. more than 400 parts per million (15) Solutions identified in paragraph dodecylbenzenesulfonic acid and not (b)(20) of this section are for single use more than 80 parts per million of applications only and shall provide, polyoxyethylene-polyoxypropylene when ready to use, a level of 800 parts block polymers (having a minimum av- per million of total active phenols con- erage molecular weight of 2,800) or not sisting of 400 parts per million ortho- more than 40 parts per million of iso- phenylphenol, 320 parts per million propyl alcohol. ortho-benzyl-para-chlorophenol and 80 (6) Solutions identified in paragraph parts per million para- (b)(9) of this section shall provide when tertiaryamylphenol. ready to use no more than 200 parts per (16) Solution identified in paragraph million of the active quaternary com- (b)(21) of this section shall provide not pound. more than 430 parts per million and not (7) Solutions identified in paragraph less than 25 parts per million of sodium (b)(10) of this section shall provide not dodecylbenzenesulfonate. more than sufficient (17) Solutions identified in paragraph trichloromelamine to produce 200 parts (b)(22) of this section shall provide, per million of available chlorine and ei- when ready to use, at least 150 parts ther sodium lauryl sulfate at a level per million and not more than 400 parts not in excess of the minimum required per million of active quaternary com- to produce its intended functional ef- pound. fect or not more than 400 parts per mil- (18) Solutions identified in paragraph lion of dodecylbenzenesulfonic acid. (b)(23) of this section shall provide at (8) Solutions identified in paragraph least 150 parts per million and not (b)(11) of this section shall provide, more than 200 parts per million of the when ready to use, not more than 200 active quaternary compound. parts per million of active quaternary (19) Solutions identified in para- compound. graphs (b)(24), (b)(25), and (b)(43) of this (9) The solution identified in para- section shall provide at least 12.5 parts graph (b)(12) of this section shall proper million and not more than 25 parts vide not more than 200 parts per mil- per million of titratable iodine. The ad- lion of sulfonated oleic acid, sodium juvants used with the iodine shall not salt. be in excess of the minimum amounts (10) Solutions identified in paragraph required to accomplish the intended (b)(15) of this section will provide not technical effect. more than 200 parts per million of (20)–(21) [Reserved]

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(22) Solutions identified in paragraph the amounts required to accomplish (b)(27) of this section shall provide, the intended technical effect. when ready to use, at least 109 parts (28) Solutions identified in paragraph per million and not more than 218 parts (b)(33) of this section shall provide, per million of total active fatty acids when ready to use, at least 150 parts and at least 156 parts per million and per million and not more than 400 parts not more than 312 parts per million of per million of active quaternary com- the sodium 1-octanesulfonate. pounds. The adjuvants used with the (23) Solutions identified in paragraph quaternary compounds shall not exceed (b)(28) of this section shall provide, the amounts required to accomplish when ready to use, at least 156 parts the intended technical effect. per million and not more than 312 parts Tetrasodium ethylenediamine per million of sulfonated 9- tetraacetate shall be added at a min- octadecenoic acid, at least 31 parts per imum level of 60 parts per million. Use million and not more then 62 parts per of these sanitizing solutions shall be million of sodium xylenesulfonate. limited to conditions of water hardness (24) Solutions identified in paragraph not in excess of 300 parts per million. (b)(29) of this section will provide at (29) Solutions identified in paragraph least 237 parts per million and not (b)(34) of this section should provide, more than 474 parts per million when ready to use, at least 100 parts dodecyldiphenyloxidedisulfonic acid, at per million and not more than 200 parts least 33 parts per million and not more per million available chlorine dioxide than 66 parts per million sulfonated as determined by the method titled tall oil fatty acid, and at least 87 parts ‘‘Iodometric Method for the Deter- per million and not more than 174 parts mination of Available Chlorine Dioxide per million neo-decanoic acid. (50–250 ppm available ClO2),’’ which is incorporated by reference. Copies are (25) Solutions identified in paragraph available from the Center for Food (b)(30) of this section shall provide, Safety and Applied Nutrition (HFS– when ready to use, not less than 550 200), Food and Drug Administration, parts per million and not more than 5100 Paint Branch Pkwy., College Park, 1,100 parts per million hydrogen per- MD 20740, or available for inspection at oxide, not less than 100 parts per mil- the Office of the Federal Register, 800 lion and not more than 200 parts per North Capitol Street, NW., suite 700, million peracetic acid, not less than 150 Washington, DC 20408. parts per million and not more than 300 (30) Solutions identified in paragraph parts per million acetic acid, and not (b)(35) of this section shall provide, less than 15 parts per million and not when ready for use, at least 117 parts more than 30 parts per million 1- per million and not more than 234 parts hydroxyethylidene-1,1-diphosphonic per million of total fatty acids and at acid. least 166 parts per million and not (26) The solution identified in para- more than 332 parts per million of a graph (b)(31) of this section shall pro- mixture of naphthalenesulfonates. The vide, when ready to use, at least 12.5 adjuvants phosphoric acid and lactic parts per million and not more than 25 acid, used with decanoic acid, octanoic parts per million of titratable iodine. acid, and sodium naphthalenesulfonate The adjuvants used with the iodine will and its alkylated derivatives, will not not be in excess of the minimum be in excess of the minimum amounts amounts required to accomplish the in- required to accomplish the intended tended technical effect. technical effects. (27) Solutions identified in paragraph (31) Solutions identified in paragraph (b)(32) of this section shall provide, (b)(36) of this section shall provide, when ready to use, at least 150 parts when ready for use, at least 29 parts per per million and no more than 400 parts million and not more than 58 parts per per million of active quarternary com- million decanoic acid; at least 88 parts pounds in solutions containing no more per million and not more than 176 parts than 600 parts per million water hard- per million of octanoic acid; at least 69 ness. The adjuvants used with the parts per million and not more than 138 quarternary compounds will not exceed parts per million of lactic acid; at least

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256 parts per million and not more than parts per million of hydrogen peroxide; 512 parts per million of phosphoric not less than 200 parts per million and acid; at least 86 parts per million and not more than 315 parts per million of not more than 172 parts per million of peroxyacetic acid; not less than 200 1-octanesulfonic acid; at least 51 parts parts per million and not more than 340 per million and not more than 102 parts parts per million of acetic acid; not per million of 1-octanesulfonic-2- less than 10 parts per million and not sulfinic acid or 1,2-octanedisulfonic more than 20 parts per million of sul- acid; and at least 10 parts per million furic acid; and not less than 0.75 parts and not more than 20 parts per million per million and not more than 1.2 parts of the condensate of four moles of per million of 2,6-pyridinedicarboxylic poly(oxyethylene)poly(oxypropylene) acid. block copolymers with one mole of (34) Solutions identified in paragraph ethylenediamine. The colorant adju- (b)(39) of this section shall provide vant FD&C Yellow No. 5 shall not be when ready for use not less than 460 used in excess of the minimum amount parts per million and not more than 625 required to accomplish the intended parts per million of phosphoric acid, technical effect. and all components shall be present in (32)(i) The solution identified in para- the following proportions: 1 part phos- graph (b)(37) of this section without po- phoric acid to 0.25 octenyl succinic acid tassium bromide shall provide, when to 0.18 part N,N-dimethyloctanamine to ready to use, at least 100 parts per mil- 0.062 part of a mixture of n-carboxylic lion and not more than 200 parts per acids (C6-C12, consisting of not less million of available halogen deter- than 56 percent octanoic acid and not mined as available chlorine; at least less than 40 percent decanoic acid). 2,958 parts per million and not more (35) Solutions identified in paragraph than 5,916 parts per million of tri- (b)(40) of this section shall provide sodium phosphate; at least 1 part per when ready for use not less than 12.5 million and not more than 3 parts per parts per million and not more than million of sodium lauryl sulfate; and at 25.0 parts per million of titratable io- least 0.3 part per million and not more dine; and not less than 2.7 parts per than 0.7 part per million on potassium million and not more than 5.5 parts per permanganate. million of dodecylbenzene sulfonic (ii) The solution identified in para- acid. All components shall be present graph (b)(37) of this section with potas- in the following proportions: 1.0 part sium bromide shall provide, when dodecylbenzene sulfonic acid to 43 ready to use, at least 25 parts per mil- parts sodium N-cyclohexyl-N-palmitoyl lion and not more than 200 parts per taurate to 7.7 parts chloroacetic acid, million of available halogen deter- sodium salt, reaction products with 4,5- mined as available chlorine; at least 15 dihydro-2-undecyl-1H-imidazole-1-eth- parts per million and not more than 46 anol and sodium hydroxide to 114 parts parts per million of potassium bro- phosphoric acid to 57 parts isopropyl mide; at least 690 parts per million and alcohol to 3.0 parts calcium chloride. not more than 2,072 parts per million of (36) Solutions identified in paragraph trisodium phosphate; at least 0.3 part (b)(41) of this section shall provide, per million and not more than 1 part when ready for use, not less than 150 per million of sodium lauryl sulfate; parts per million and not more than 200 and at least 0.1 part per million and parts per million of n-alkyl(C12- not more than 0.3 part per million of C16)benzyldimethylammonium chlo- potassium permanganate. ride; and not more than 0.4 part per (iii) Magnesium oxide when used in million of the colorant methylene blue. paragraph (c)(32) (i) or (ii) of this sec- Components shall be present in the tion shall not be used in excess of the product used to prepare the solution in minimum amount required to accom- the following proportions: 1 part n- plish its intended technical effect. alkyl(C12- (33) Solutions identified in paragraph C16)benzyldimethylammonium chloride (b)(38) of this section shall provide to 0.24 part ammonium chloride to 0.08 when ready for use not less than 300 part calcium stearate to 0.60 part so- parts per million and not more than 465 dium bicarbonate to 0.08 part starch or

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dextrin, or a combination of starch and parts per million and not more than 34 dextrin. parts per million of 1- (37)(i) The solution identified in para- hydroxyethylidene-1,1-diphosphonic graph (b)(42) of this section not con- acid; and at least 36 parts per million taining sulfuric acid shall provide when and not more than 109 parts per million ready for use not less than 45 parts per of sodium 1-octanesulfonate. million and not more than 90 parts per (ii) The solution identified in para- million of decanoic acid; and all com- graph (b)(45) of this section, when used ponents shall be present in the fol- on food-contact equipment and utensils lowing proportions (weight/weight (w/ in warewashing machines, including w)): 1 part decanoic acid to 1 part nona- warewashing machines in public eating noic acid to 9.5 parts phosphoric acid to places, at temperatures no less than 120 3.3 parts propionic acid to 3.3 parts so- °F (49 °C) shall provide when ready for dium 1-octanesulfonate. use at least 30 parts per million and (ii) The solution identified in para- not more than 91 parts per million of graph (b)(42) of this section containing hydrogen peroxide; at least 19 parts per sulfuric acid shall provide when ready million and not more than 58 parts per for use not less than 45 parts per mil- million of peroxyacetic acid; at least 17 lion and not more than 90 parts per parts per million and not more than 52 million of decanoic acid; and all com- parts per million of octanoic acid (in- ponents shall be present in the fol- cluding peroxyoctanoic acid); at least lowing proportions (w/w): 1 part deca- 119 parts per million and not more than noic acid to 1 part nonanoic acid to 2.8 290 parts per million of acetic acid; at parts phosphoric acid to 3.3 parts propi- least 3 parts per million and not more onic acid to 3.3 parts sodium 1- than 14 parts per million of 1- octanesulfonate to 3.2 parts sulfuric hydroxyethylidene-1,1-diphosphonic acid. acid; and at least 15 parts per million (38) The solution identified in para- and not more than 46 parts per million graph (b)(44) of this section shall proof sodium 1-octanesulfonate. vide, when ready for use, at least 16,450 (iii) The solution identified in para- parts per million and not more than graph (b)(45) of this section, when used 32,900 parts per million of citric acid; at on dairy or beverage containers, shall least 700 parts per million and not provide when ready for use at least 36 more than 1,400 parts per million of di- parts per million and not more than 108 sodium ethylenediaminetetraacetate; parts per million of hydrogen peroxide; at least 175 parts per million and not at least 23 parts per million and not more than 350 parts per million of so- more than 69 parts per million of per- dium lauryl sulfate; and at least 175 oxyacetic acid; at least 20 parts per parts per million and not more than 350 million and not more than 61 parts per parts per million of monosodium phos- million of octanoic acid (including phate. peroxyoctanoic acid); at least 140 parts (39)(i) The solution identified in para- per million and not more than 343 parts graph (b)(45) of this section, when used per million of acetic acid; at least 3 on food processing equipment and uten- parts per million and not more than 17 sils, including dairy and beverage-proc- parts per million of 1- essing equipment but excluding food- hydroxyethylidene-1,1-diphosphonic contact surfaces in public eating places acid; and at least 18 parts per million and dairy and beverage containers, and not more than 55 parts per million shall provide when ready for use at of sodium 1-octanesulfonate. least 72 parts per million and not more (40) The solution identified in para- than 216 parts per million of hydrogen graph (b)(46) of this section shall pro- peroxide; at least 46 parts per million vide, when ready for use, at least 100 and not more than 138 parts per million parts per million and not more than 200 of peroxyacetic acid; at least 40 parts parts per million of chlorine dioxide as per million and not more than 122 parts determined by the method developed per million of octanoic acid (including by Bio-cide International, Inc., enti- peroxyoctanoic acid); at least 281 parts tled, ‘‘Iodometric Method for the De- per million and not more than 686 parts termination of Available Chlorine Di- per million of acetic acid; at least 7 oxide (50–250 ppm Available ClO2),’’ 358

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dated June 11, 1987, which is incor- Federal Insecticide, Fungicide, and porated by reference in accordance Rodenticide Act. with 5 U.S.C. 552(a) and 1 CFR part 51. [42 FR 14609, Mar. 16, 1977] Copies of this method are available from the Division of Petition Control, EDITORIAL NOTE: For FEDERAL REGISTER ci- Center for Food Safety and Applied Nu- tations affecting § 178.1010, see the List of CFR Sections Affected, which appears in the trition (HFS–215), Food and Drug Ad- Finding Aids section of the printed volume ministration, 5100 Paint Branch Pkwy., and on GPO Access. College Park, MD 20740, and may be examined at the Center for Food Safety Subpart C—Antioxidants and and Applied Nutrition’s Library, Food Stabilizers and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, § 178.2010 Antioxidants and/or stabi- or at the Office of the Federal Register, lizers for polymers. 800 North Capitol St. NW., suite 700, The substances listed in paragraph Washington, DC; at least 380 parts per (b) of this section may be safely used as million and not more than 760 parts per antioxidants and/or stabilizers in poly- million of sodium gluconate; and at mers used in the manufacture of arti- least 960 parts per million and not cles or components of articles intended more than 1,920 parts per million of so- for use in producing, manufacturing, dium mono- and packing, processing, preparing, treat- didodecylphenoxybenzenedisulfonate. ing, packaging, transporting, or hold- Other components listed under para- ing food, subject to the provisions of graph (b)(46) of this section shall be this section: used in the minimum amount nec- (a) The quantity used shall not ex- essary to produce the intended effect. ceed the amount reasonably required (d) Sanitizing agents for use in ac- to accomplish the intended technical cordance with this section will bear la- effect. beling meeting the requirements of the (b) List of substances:

Substances Limitations

N-n-Alkyl-N′-(carboxymethyl)-N,N′- For use only: trimethylenediglycine; the alkyl group is even 1. As component of nonfood articles complying with §§ 175.105 and numbered in the range C14–C18 and the nitrogen 177.2600 of this chapter. content is in the range 5.4–5.6 weight percent. 2. At levels not to exceed 1.35 percent by weight of natural rubber, butadiene-acrylonitrile, butadiene-acrylonitrile-styrene, and butadiene-styrene polymers that are used in contact with nonalcoholic food at temperatures not to exceed room temperature and that are employed in closure-sealing gaskets complying with § 177.1210 of this chapter or in coatings complying with § 175.300, § 176.170, or § 175.320 of this chapter. The average thickness of such coatings and closure-sealing gaskets shall not exceed 0.004 inch. Alkylthiophenolics: ...... For use only: 1. Acid-catalyzed condensation reaction products 1. At levels not to exceed 2 percent by weight of adhesives complying with of 4-nonylphenol, formaldehyde, and 1- § 175.105 of this chapter, of pressure-sensitive adhesives complying with dodecanethiol (CAS Reg. No. 164907–73–7).. § 175.125 of this chapter, and of rubber articles complying with § 177.2600 of this chapter. 2. Acid-catalyzed condensation reaction products 2. Do. of branched 4-nonylphenol, formaldehyde, and 1-dodecanethiol (CAS Reg. No. 203742–97–6).. p-tert-Amylphenolformaldehyde resins produced For use only at levels not to exceed 2.1 percent by weight of polyamide when one mole of p-tert-amylphenol is made to resins that are: react under acid conditions with one mole of 1. Derived from dimerized vegetable oil acids (containing not more than 20 formaldehyde. percent of monomer acids) and ethylenediamine. 2. Used in compliance with regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter. 1,4-Benzenedicarboxylic acid, bis[2-(1,1- For use only at levels not to exceed 0.075 percent by weight of olefin poly- dimethylethyl)-6-[[3-(1,1-dimethylethyl)-2-hy- mers complying with § 177.1520 of this chapter. droxy-5-methylphenyl]methyl]-4-methylphenyl]ester (CAS Reg. No. 57569–40–1). 2-(2H-Benzotriazol-2-yl)-4,6-bis(1-methyl-1- For use only: phenylethyl)phenol (CAS Reg. No. 70321–86–7). 1. At levels not to exceed 0.5 percent by weight of polyethylene phthalate polymers complying with § 177.1630 of this chapter. 2. At levels not to exceed 3.0 percent by weight of polycarbonate resins complying with § 177.1580 of this chapter.

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Substances Limitations

2-(2H-Benzotriazol-2-yl)-4-(1, 1, 3, 3- For use only at levels not to exceed 0.5 percent by weight of polycarbonate tetramethylbutyl) phenol (CAS Reg. No. 3147– resins complying with § 177.1580 of this chapter: Provided, That the fin- 75–9). ished resins contact food only under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. 2-[4,6-Bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5- For use only: (octyloxy)phenol (CAS Reg. No. 2725–22–6).. 1. At levels not to exceed 0.3 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter in contact with food types I, II, IV–B, VI, VII–B, and VIII described in § 176.170(c) of this chapter, table 1, under conditions of use D through G as described in § 176.170(c), table 2, of this chapter. 2. At levels not to exceed 0.1 percent by weight of polypropylene complying with § 177.1520(c) of this chapter, items 1.1a, 1.2, and 1.3 in contact with food under conditions of use A through H as described in § 176.170(c), table 2, of this chapter. 3. At levels not to exceed 0.04 percent by weight of polyethylene and olefin copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.1c, 3.2a, and 3.2b having a minimum density of 0.94 gram per cubic centimeter, in contact with food under conditions of use A through H as described in § 176.170, table 2, of this chapter provided that the finished articles used in contact with fatty food types III, IV–A, V, VII–A, and IX as described in table 1 of § 176.170(c) of this chapter hold a minimum of 2 gallons (7.6 liters) of food. 4. At levels not to exceed 0.4 percent by weight of ethylene copolymers complying with § 177.1520(c) of this chapter, items 3.1a, 3.1b, 3.1c, 3.2a, and 3.2b, having a density of less than 0.94 gram per cubic centimeter, in contact with food under conditions of use B through H, as described in § 176.170(c), table 2, of this chapter provided that the finished articles used in contact with fatty food types III, IV–A, V, VII–A, and IX hold a minimum of 5 gallons (18.9 liters) of food. 5. At levels not to exceed 0.04 percent by weight of polyethylene having a density of less than 0.94 gram per cubic centimeter, and olefin polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.3a, 3.3b, 3.4, 3.5, 3.6, 4, 5, and 6, in contact with food under conditions of use D through G as described in § 176.170(c) of this chapter, table 2, provided that the finished articles used in contact with fatty food types III, IV–A, V, VII–A, and IX hold a minimum of 5 gallons (18.9 liters) of food. b, 3(or 4)-Bis(octadecylthio)cyclohexylethane (CAS For use only: Reg. No. 37625–75–5); CAS synonym: 1-[(beta- 1. At levels not to exceed 0.3 percent by weight of all polymers for use in (octadecylthio)ethyl]-3(or 4)- contact with foods of Types I, II, IV-B, VI, VII-B, and VIII under conditions (octadecylthio)cyclohexane. of use B through H as described in tables 1 and 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.3 percent by weight of polyolefins complying with § 177.1520 of this chapter, for use in contact with food of types III, IV-A, V, VII-A, and IX under conditions of use C through G as described in tables 1 and 2 of § 176.170(c) of this chapter. Bis(2,2,6,6-tetramethyl-4-piperidinyl) sebacate For use only: (CAS Reg. No. 52829–07–9). 1. In adhesives complying with § 175.105 of this chapter. 2. At levels not to exceed 0.1 percent by weight of pressure-sensitive adhesives complying with § 175.125 of this chapter.

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Substances Limitations

Bis(2,4-di-tert-butyl-6-methylphenyl) ethyl For use only: phosphite (CAS Reg. No. 145650–60–8). 1. At levels not to exceed 0.3 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter. The finished polymers may only be used with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, VI-A, VI-B, VII-B, and VIII, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.1 percent by weight of propylene polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 3.2b, 3.4, or 3.5, or 3.1a (where the density of this polymer is at least 0.85 gram per cubic centimeter and less than 0.91 gram per cubic centimeter). The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories III, IV- A, V, VI-C, VII-A, and IX, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.1 percent by weight of high-density ethylene polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or 3.6 (where the density of each of these polymers is at least 0.94 gram per cubic centimeter), or 5. The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use C (maximum temperature 70 °C) through G described in table 2 of § 176.170(c) of this chapter. Pro- vided, that the finished food contact articles have a volume of at least 18.9 liters (5 gallons). 4. At levels not to exceed 0.01 percent by weight of low-density ethylene polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, or 3.6 (where the density of each of these polymers is less than 0.94 gram per cubic centimeter). The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. Provided, that the average thickness of such polymers in the form in which they contact food shall not exceed 0.001 inch. 1,2-Bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)- For use only: hydrazine (CAS Reg. No. 32687–78–8). 1. As provided in § 175.105 of this chapter. 2. At levels not exceeding 0.1 percent by weight of acrylonitrile-butadiene- styrene copolymers used in accordance with parts 175, 176, 177, and 181 of this chapter. 3. At levels not exceeding 0.1 percent by weight of polyoxymethylene copolymers complying with § 177.2470 of this chapter and of polyoxymethylene homopolymers complying with § 177.2480 of this chapter. 2,6-Bis(1-methylheptadecyl)-p-cresol ...... For use only at levels not exceeding 0.3 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4. The average thickness of such polymers in the form in which they contact fatty food or food containing more than 8 percent of alcohol shall not exceed 0.004 inch. 3,9-Bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]- For use only: 2,4,8,10-tetraoxa-3,9- 1. At levels not to exceed 0.15 percent by weight of all polymers, except as diphosphaspiro[5.5]undecane (CAS Reg. No. specified below. 154862–43–8), which may contain not more 2. At levels not to exceed 0.2 percent by weight of polycarbonate resins than 2 percent by weight of triisopropanolamine complying with § 177.1580 of this chapter. (CAS Reg. No. 122–20–3). 3. At levels not to exceed 0.3 percent by weight of polyetherimide resins complying with § 177.1595 of this chapter.

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Substances Limitations

5,7-Bis(1,1-dimethylethyl)-3-hydroxy-2(3H)- For use only: benzofuranone, reaction products with o-xylene 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- (CAS Reg. No. 181314–48–7). plying with § 177.1520(c) of this chapter. The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, Table 1, under Categories I, II, IV–B, VI–A, VI–B, VII–B, and VIII, and under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.02 percent by weight of: (a) Propylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 3.1a, 3.2a, 3.2b, 3.4, or 3.5. The finished polymer may only be used in contact with food of types identified in § 176.170(c) of this chapter, Table 1, under Categories III, IV–A, V, VI–C, VII–A, and IX, and under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter; or (b) Ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or 3.6 (where the density of each of these polymers is at least 0.94 gram per cubic centimeter), or 5. The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, Table 1, under Categories III, IV–A, V, VI–C, VII–A, and IX, and under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter; provided that the finished food-contact articles have a volume of at least 18.9 liters (5 gallons). 3. At levels not to exceed 0.02 percent by weight of ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, or 3.6 (where the density of each of these polymers is less than 0.94 gram per cubic centimeter). The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, Table 1, under Categories III, IV–A, V, VI–C, VII–A, and IX, and under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter; provided that the average thickness of such polymers in the form in which they contact food shall not exceed 50 micrometers (0.002 inch). 3,9-Bis[2-{3-(3-tert-butyl-4-hydroxy-5- For use only: methylphenyl)propionyloxy}-1,1-dimethylethyl]- 1. At levels not to exceed 0.2 percent by weight of polypropylene complying 2,4,8,10-tetraoxaspiro[5.5]undecane (CAS Reg. with § 177.1520(c), item 1.1 of this chapter. The finished polymer is to be No. 90498–90–1). used in contact with food only under conditions of use D through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.3 percent by weight of polyethylene complying with § 177.1520(c) of this chapter, item 2.1, provided that the polymer has a minimum density of 0.94 grams per cubic centimeter and is used in contact with food only under conditions of use D through G described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.3 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 3.1, and 3.2, where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from propylene. The finished polymer is to be used in contact with food of types I, II, IV–B, VI–A, VI–B, VI–C, VII–B, and VIII under conditions of use A through H described in tables 1 and 2 of § 176.170(c) of this chapter.

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Substances Limitations

4-[[4,6-Bis(octylthio)-s-triazin-2-yl]amino]-2,6-di- For use only: tert-butylphenol (CAS Reg. No. 991–84–4). 1. At levels not to exceed 0.5 percent by weight: in styrene block copolymers complying with § 177.1810 of this chapter; in rosins and rosin derivatives complying with § 175.300(b)(3)(v) of this chapter; in can end cement formulations complying with § 175.300(b)(3)(xxxi) of this chapter; in side seam cement formulations complying with § 175.300(b)(3)(xxxii) of this chapter; in petroleum alicyclic hydrocarbon resins and terpene resins complying with § 175.320(b)(3) of this chapter; in rosin and rosin derivatives complying with § 176.170(a)(5) of this chapter; in petroleum alicyclic hydrocarbon resins or their hydrogenated products complying with § 176.170(b)(2) of this chapter; in terpene resins complying with § 175.300(b)(2)(xi) of this chapter, when such terpene resins are used in accordance with § 176.170(b)(1) of this chapter; in resins and polymers complying with § 176.180(b) of this chapter; in closures with sealing gaskets complying with § 177.1210 of this chapter; in petroleum hydrocarbon resin and rosins and rosin derivatives complying with § 178.3800(b) of this chapter; and in reinforced wax complying with § 178.3850 of this chapter. 2. At levels not to exceed 0.2 percent by weight of the finished cellophane complying with § 177.1200 of this chapter. 3. At levels not to exceed 0.1 percent by weight in polystyrene and rubber- modified polystyrene complying with § 177.1640 of this chapter: Provided, That the finished polystyrene and rubber-modified polystyrene polymer contact food only under conditions of use B through G described in table 2 of § 176.170(c) of this chapter. 4. In adhesives complying with § 175.105 of this chapter; in pressure-sensitive adhesives complying with § 175.125 of this chapter; and as provided in § 177.2600 of this chapter. 4,4′-Bis(a,a-dimethylbenzyl)diphenylamine (CAS For use at levels not to exceed 0.3 percent by weight of polypropylene Reg. No. 10081–67–1). complying with § 177.1520(c) of this chapter. The polypropylene articles are limited to use in contact with non-fatty foods only. Boric acid (CAS Reg. No. 10043–35–3) ...... For use only at levels not to exceed 0.16 percent by weight of ethylene- vinyl acetate-vinyl alcohol copolymers complying with § 177.1360(a)(3) and (d) of this chapter. 1,3–Butanediol. Butylated reaction product of p-cresol and For use only: dicyclopentadiene produced by reacting p-cresol 1. As components of nonfood articles complying with §§ 175.105 and and dicyclopentadiene in an approximate mole 177.2600(c)(4)(iii) of this chapter. ratio of 1.5 to 1, respectively, followed by 2. At levels not to exceed 1.0 percent by weight of acrylonitrile/butadiene/ alkylation with isobutylene so that the butyl con- styrene copolymers. The finished copolymers may be used in contact tent of the final product is not less than 18 per- with food of Types I, II, IV–B, VI–A, VI–B, VII–B, and VIII under condi- cent. tions of use B through H, as described in tables 1 and 2 of § 176.170(c) of this chapter, and with food of Types III, IV–A, V, VI–C, VII–A, and IX under conditions of use C through G as described in tables 1 and 2 of § 176. 170(c) of this chapter. Butylated, styrenated cresols produced when For use only: equal moles of isobutylene, styrene, and a 1. As provided in §§ 175.105 and 177.2600 of this chapter. metacresol-paracresol mixture having a no more 2. At levels not to exceed 0.5 percent by weight of polystyrene, rubber- than 3 °C distillation range including 202 °C are modified polystyrene, or olefin polymers complying with § 177.1520 (c) of made to react so that the final product meets this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4, or com- the following specifications: Not less than 95 plying with other sections in parts 174, 175, 176, 177, 178 and § 179.45 percent by weight of total alkylated phenols con- of this chapter, used in articles that contact food only unded the condi- sisting of 13–25 percent by weight of butylated tions described in § 176.170(c) of this chapter, table 2, under conditions m- and p-cresols, 26–38 percent by weight of of use C through G. styrenated m- and p-cresols, 37–49 percent by weight of butylated styrenated m- and p-cresols, and not more than 10 percent by weight total of alkylated xylenols, alkylated o-cresol, alkylated phenol, and alkylated ethylphenol; acidity not more than 0.003 percent; and refractive index at 25 °C of 1.5550–1.5650, as determined by ASTM method D1218–82, ‘‘Standard Test Meth- od for Refractive Index and Refractive Disper- sion of Hydrocarbon Liquids,’’ which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Reg- ister, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

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Substances Limitations

2-tert-Butyl-a(3-tert-butyl-4-hydroxyphenyl)-p-cu- For use only: menyl bis(p-nonylphenyl) phosphite; the nonyl 1. As components of nonfood articles complying with §§ 175.105 and group is a propylene trimer isomer and the 177.2600 of this chapter. phosphorus content is in the range 3.8–4.0 2. At levels not to exceed 1.35 percent by weight of natural rubber, buta- weight percent. diene-acrylonitrile, butadiene-acrylonitrile-styrene, and butadiene-styrene polymers that are used in contact with nonalcoholic food at temperatures not to exceed room temperature and that are employed in closure-sealing gaskets complying with § 177.1210 of this chapter or in coatings complying with § 175.300, § 175.320, or § 176.170 of this chapter. The average thickness of such coatings and closure-sealing gaskets shall not exceed 0.004 inch. 2-(3′-tert-Butyl-2′-hydroxy-5′-methyl-phenyl)-5- For use only at levels not to exceed 0.5 percent by weight of olefin poly- chlorobenzotriazole with a melting point of 137– mers complying with § 177.1520(c) of this chapter, provided that the fin- 141 °C. ished polymer contacts foods only of the types identified in Categories I, II, IV-B, VI-A and B, VII-B, and VIII in table 1, § 176.170 of this chapter. 4,4′-Butylidenebis(6-tert-butyl-m-cresol) ...... For use only. 1. As provided in §§ 175.105 and 177.2600 of this chapter. 2. At levels not to exceed 0.5 percent by weight of polypropylene complying with § 177.1520 of this chapter and for use at levels not to exceed 0.3 percent by weight of polyethylene complying with § 177.1520 of this chapter, provided that the finished polypropylene and polyethylene contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, VI–B, and VIII. Butyric acid, 3,3-bis(3-tert-butyl-4- For use only: hydroxyphenyl)ethylene ester (CAS Reg. No. 1. At levels not to exceed 0.5 percent by weight of olefin copolymers com- 32509–66–3). plying with § 177.1520(c) of this chapter, items 3.1 and 3.2 except that when used in contact with foods described as types III, IV–A, V, VII–A, and IX in table 1 of § 176.170(c) of this chapter, the olefin copolymers may only be used under conditions of use E, F, and G set forth in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.5 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, item 1.1, 3.1, or 3.2 (where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight-percent of polymer units derived from propylene). 3. At levels not to exceed 0.2 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 3.1, and 3.2. Calcium benzoate..

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Substances Limitations

Calcium bis[monoethyl(3,5-di-tert-butyl-4-hydroxy- For use only: benzyl)phosphonate] (CAS Reg. No. 65140–91– 1. At levels not to exceed 0.25 percent by weight of polypropylene that 2). complies with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3. 2. At levels not to exceed 0.2 percent by weight of polyethylene and olefin copolymers that comply with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, 3.4, 3.5, and 3.6. Finished polymers having a density less than 0.94 gram per cubic centimeter shall be used in contact with food only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 3. In adhesives complying with § 175.105 of this chapter. 4. At levels not to exceed 0.5 percent by weight of pressure-sensitive adhesives complying with § 175.125 of this chapter. 5. At levels not to exceed 0.5 percent by weight of rosins and rosin derivatives complying with § 175.300(b)(3)(v) of this chapter. 6. At levels not to exceed 0.5 percent by weight of can end cement formulations complying with § 175.300(b)(3)(xxxi) of this chapter. 7. At levels not to exceed 0.5 percent by weight of side seam cement formulations complying with § 175.300(b)(3)(xxxii) of this chapter. 8. At levels not to exceed 0.5 percent by weight of petroleum alicyclic hydrocarbon resins complying with § 175.320(b)(3) of this chapter. 9. At levels not to exceed 0.5 percent by weight of rosin and rosin derivatives complying with § 176.170(a)(5) of this chapter; and petroleum alicyclic hydrocarbon resins, or the hydrogenated product thereof, complying with § 176.170(b)(2) of this chapter. 10. At levels not to exceed 0.5 percent by weight of resins and polymers used as components of paper and paperboard in contact with dry food in compliance with § 176.180 of this chapter. 11. At levels not to exceed 0.5 percent by weight of closures with sealing gaskets complying with § 177.1210 of this chapter. 12. At levels not to exceed 0.5 percent by weight of the finished rubber article complying with § 177.2600 of this chapter. 13. At levels not to exceed 0.5 percent by weight of petroleum hydrocarbon resin and rosins and rosin derivatives complying with § 178.3800(b). 14. At levels not to exceed 0.5 percent by weight of reinforced wax complying with § 178.3850. 15. At levels not to exceed 0.3 percent by weight of polyethylene phthalate polymers, complying with § 177.1630 of this chapter. Provided, that the finished polymers contact food only under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter. Calcium myristate.. Calcium ricinoleate...... For use only at levels not to exceed 1 percent by weight of polyoxymethylene copolymer as provided in § 177.2470(b)(1) of this chapter. Calcium stearate.. Carbethoxymethyl diethyl phosphonate (CAS Reg. At levels not to exceed 0.07 percent by weight of polyethylene phthalate No. 867–13–0). polymers complying with § 177.1630 of this chapter. Cerium stereate (CAS Reg. No. 10119–53–6) ...... For use only at levels not to exceed 0.5 percent by weight in rigid and semirigid vinyl chloride homo– and copolymer articles modified in accordance with § 178.3790(b)(1) of this chapter that contact food under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. Cupric acetate and lithium iodide ...... For use at levels not exceeding 0.025 percent cupric acetate and 0.065 percent lithium iodide by weight of nylon 66 resins complying with § 177.1500 of this chapter; the finished resins are used or are intended to be used to contain foods during oven baking or oven cooking at temperatures above 250 °F. The average thickness of such resins in the form in which they contact food shall not exceed 0.0012 inch. Cuprous iodide ...... For use at levels not exceeding 0.01 percent cuprous iodide by weight of nylon 66T resins complying with § 177.1500 of this chapter; the finished resins are used or are intended to be used to contain foods during oven baking or oven cooking at temperatures above 250 °F. The average thickness of such resins in the form in which they contact food shall not exceed 0.001 inch. Cuprous iodide and cuprous bromide ...... For use at levels not exceeding 0.0025 percent cuprous iodide and 0.0175 percent cuprous bromide by weight of nylon 66 resins complying with § 177.1500 of this chapter; the finished resins are used or are intended to be used to contain foods during oven baking or oven cooking at temperatures above 250 °F. The average thickness of such resins in the form in which they contact food shall not exceed 0.0015 inch. Cyanoguanidine ...... For use only at levels not to exceed 1 percent by weight of polyoxymethylene copolymer as provided in § 177.2470(b)(1) of this chapter.

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Substances Limitations

Cyclic neopentanetetrayl bis(octadecyl phosphite) For use only at levels not to exceed 0.1 percent by weight of ethylene-vinyl (CAS Reg. No. 3806–34–6); the phosphorus acetate copolymers complying with § 177.1350 of this chapter that con- content is in the range of 7.8 to 8.2 weight per- tact food under conditions of use E, F, and G described in table 2 of cent. § 176.170(c) of this chapter. Cyclic neopentanetetrayl bis(octadecyl phosphite) For use only: (CAS Reg. No. 3806–34–6) (which may contain 1. At levels not to exceed 0.25 percent by weight of olefin polymers com- not more than 1 percent by weight of plying with § 177.1520(c) of this chapter, items 1.1, 2.1, and 3.1. triisopropanolamine (CAS Reg. No. 122–20–3)); 2. At levels not to exceed 0.25 percent by weight of olefin polymers com- the phosphorus content is in the range of 7.8 to plying with § 177.1520(c) of this chapter, item 2.2, that contact food 8.2 weight percent. Types I, II, VI-A, VII-B, and VIII described in table 1 of § 176.170(c) of this chapter under conditions of use B (for boil-in-bag applications), C, D, E, F, G, and H described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.15 percent by weight of olefin polymers complying with § 177.1520, items 1.1 and 3.2, that contact food Types I, II, VI-A, VII-B, and VIII described in table 1 of § 176.170(c) of this chapter under conditions of use B (for boil-in-bag applications), C, D, E, F, G, and H described in table 2 of § 176.170(c) of this chapter. 4. At levels not to exceed 0.20 percent by weight of polystyrene and/or rubber modified polystyrene complying with § 177.1640 of this chapter that contact food under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. 4,4′-Cyclohexylidenebis(2-cyclohexylphenol) ...... For use only at levels not to exceed 0.1 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4: Provided, That the finished polymers contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, VI, VII-B, and VIII. Dicetyl thiodipropionate having a melting point of The concentration of this additive and any other permitted antioxidants in 59°–62 °C as determined by ASTM method the finished food-contact article shall not exceed a total of 0.5 milligram E324–79, ‘‘Standard Test Method for Relative per square inch of food-contact surface. Initial and Final Melting Points and the Melting Range of Organic Chemicals,’’ and a saponification value in the range 176–183 as determined by ASTM method D1962–67 (Reapproved 1979), ‘‘Standard Test Method for Saponification Value of Drying Oils, Fatty Acids, and Polym- erized Fatty Acids,’’ which are incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Wash- ington, DC 20408. Didodecyl– 1,4–dihydro–2,6–dimethyl–3,5– For use only at levels not to exceed 0.3 percenmt by weight in rigid poly- pyridinedicarboxylate (CAS Reg. No. 36265–41– mer articles modified in accordance with § 178.3790 that contact food, 5). under conditions of use E, F, and G described in table 2 of § 176.170 of this chapter. 2,6-Di(a-methyl benzyl)-4-methyl phenol [Chemical For use only at levels not to exceed 0.2 percent by weight of olefin poly- Abstracts Service Registry No. 1817–68–1]. mers complying with item 3.4 in § 177.1520(c) of this chapter, provided that such olefin polymers are limited to use at a level not to exceed 25 percent by weight in other olefin polymers complying with § 177.1520 of this chapter; and the total amount in such finished olefin polymers not to exceed 0.05 percent by weight, including the level that may be contrib- uted by its presence at 6 percent in the item ‘‘butylated, styrenated cresols * * * ’’ listed in this paragraph; and further provided that the finished olefin polymers are intended for contact with foods, except those containing more than 8 percent alcohol. 2,4-Dimethyl-6-(1-methylpentadecyl)phenol (CAS For use only: Reg. No. 134701–20–5). 1. At levels not to exceed 0.3 percent by weight of acrylonitrile-butadiene- styrene copolymers used in accordance with applicable regulations in parts 175, 176, 177, and 181 of this chapter, under conditions of use C through H as described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.033 percent by weight of rigid polyvinyl chloride, under conditions of use A through H as described in table 2 of § 176.170(c) of this chapter. Dimethyl succinate polymer with 4-hydroxy- For use only: 2,2,6,6-tetramethyl-1-piperidineethanol (CAS 1. At levels not to exceed 0.3 percent by weight of olefin polymers com- Reg. No. 65447–77–0). plying with § 177.1520 of this chapter and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.3 percent by weight of ethylene-vinyl acetate copolymers complying with § 177.1350 of this chapter and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter.

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Substances Limitations

Dimethyltin/monomethyltin For use only at levels not to exceed 2 percent by weight: isooctylmercaptoacetates consisting of 5 to 90 1. In rigid polyvinyl chloride used in the manufacture of pipes intended for percent by weight of monomethyltin tris contact with water in food-processing plants, and (isooctylmercaptoacetate) (CAS Reg. No. 2. In rigid polyvinyl chloride and in rigid vinyl chloride copolymers complying 54849–38–6) or monomethyltin tris(2- with § 177.1950 of this chapter or § 177.1980 of this chapter for use in ethylhexylmercaptoacetate) (CAS Reg. No. contact with food of Types I, II, III, IV (except liquid milk), V, VI, VII, VIII, 57583–34–3) and 10 to 95 percent by weight of and IX described in table 1 of § 176.170(c) of this chapter under condi- dimethyltin bis (isooctylmercaptoacetate) (CAS tions of use C through G described in table 2 of § 176.170(c) of this Reg. No. 26636–01–1) or dimethyltin bis(2– chapter at temperatures not to exceed 88 °C (190 °F). ethylhexylmercaptoacetate) (CAS Reg. No. 57583–35–4), and no more than 0.4 percent by weight of trimethyltin compounds, and having the following specifications: Tin content (as Sn) in the range of 15 to 21 percent and mercaptosulfur content in the range of 11 to 13.5 percent. Other alkyltin compounds are not to exceed 20 ppm. Dimyristyl thiodipropionate having a melting point Finished food-contact articles containing this additive shall meet the extrac- of 48°–52 °C as determined by ASTM method tives limitations prescribed in § 176.170(c) of this chapter. E324–79, ‘‘Standard Test Method for Relative Initial and Final Melting Points and the Melting Range of Organic Chemicals,’’ and a saponification equivalent in the range 280–290 as determined by ASTM method D1962–67 (Re- approved 1979), ‘‘Standard Test Method for Sa- ponification Value of Drying Oils, Fatty Acids, and Polymerized Fatty Acids,’’ which are incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia PA 19103, or may be examined at the Office of the Federal Reg- ister, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Di(n-octyl)tin bis(2-ethylhexyl maleate) [CAS Reg. For use only at levels not to exceed 0.5 percent by weight of acrylonitrile No. 10039–33–5] having 12.5 to 15.0 percent by copolymers complying with §§ 177.1020 and 177.1030 of this chapter and weight of tin (Sn) and having a saponification used in contact with all food types under conditions of use C through G number of 260 to 280. The additive is made described in table 2 of § 176.170(c) of this chapter. from di(n-octyl)tin oxide meeting the specifications of § 178.2650(a)(1). N,N′-Diphenylthiourea ...... For use only: 1. At levels not to exceed 0.5 percent by weight of polyvinyl chloride and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. 2. At levels not to exceed 0.5 percent by weight of vinyl chloride-vinyl acetate copolymers containing not more than 20 molar percent of vinyl acetate. 2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5- For use only hexyloxy)phenol (CAS Reg. No. 147315–50–2). 1. At levels not to exceed 0.5 percent by weight of polycarbonate resins complying with § 177.1580 of this chapter. 2. At levels not to exceed 0.5 percent by weight of polyester elastomers complying with § 177.1590 of this chapter. 3. At levels not to exceed 0.5 percent by weight of polyethylene phthalate polymers complying with § 177.1630 of this chapter, in contact with food under conditions of use A through H described in Table 2 of § 176.170(c) of this chapter. 2,6-Di-tert-butyl-4-ethylphenol ...... For use only in contact with nonalcoholic foods: 1. At levels not exceeding 0.04 mg/in 2 of food contact surface and not exceeding 0.1 percent by weight in ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, and 3.3; § 177.1340; and § 177.1350 of this chapter. The average thickness of such polymers and copolymers in the form in which they contact food shall not exceed 0.0025 in. 2. At levels not exceeding 0.04 mg/in 2 of food contact surface in ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, and 3.3; § 177.1340; and § 177.1350 of this chapter. The average thickness of such polymers and copolymers in the form in which they contact food shall be greater than 0.0025 in but shall not exceed 0.025 in.

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Substances Limitations

3,5-Di-tert-butyl-4-hydroxyhydrocinnamic acid For use only: triester with 1,3,5-tris(2-hydroxyethyl)-s-triazine- 1. At levels not to exceed 0.5 percent by weight of polypropylene complying 2,4,6-(1H,3H,5H)-trione (CAS Reg. No. 34137- with § 177.1520 of this chapter in articles that contact food not in excess 09-2). of high temperature heat-sterilized condition of use A described in § 176.170(c) of this chapter, table 2. 2. At levels not to exceed 0.5 percent by weight of polyethylene complying with § 177.1520 of this chapter in articles that contact food not in excess of high temperature heat-sterilized condition of use A described in 176.170(c) of this chapter, table 2. 3. In adhesives complying with § 175.105 of this chapter. 4. At levels not to exceed 0.25 percent by weight of olefin copolymers complying with § 177.1520(c) of this chapter, items 3.1, 3.2, 3.3, 3.4, 3.5, and 4.0. 5. At levels not to exceed 2 percent by weight of polyester elastomers, complying with § 177.1590 of this chapter, in contact with dry food only, and finished rubber articles for repeated use, complying with § 177.2600 of this chapter, in contact with all foods, at temperatures not to exceed 150 °F. Di-tert-butyl-m-cresyl phosphonite condensation For use only: product with biphenyl (CAS Reg. No. 178358– 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- 58–2) produced by the condensation of 4,6-di- plying with § 177.1520(c) of this chapter, items 1.1, 2.1, 2.2, 3.1(a), tert-butyl-m-cresol with the Friedel-Crafts addi- 3.1(b), 3.2(a), or 3.2(b). tion product (phosphorus trichloride and biphenyl) so that the food additive has a minimum phosphorus content of 5.0 percent. Di-tert-butylphenyl phosphonite condensation For use only: product with biphenyl (CAS Reg. No. 119345– 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- 01–6) produced by the condensation of 2,4-di- plying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 3.2b, 3.3a, tert-butylphenol with the Friedel-Crafts addition 3.3b, 3.4, 3.5, and 3.1a (where the density is not less than 0.85 gram per product (phosphorus trichloride and biphenyl) so cubic centimeter and not more than 0.91 gram per cubic centimeter); and that the food additive has a minimum phos- 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, and 3.6 (where the density is not less than phorus content of 5.4 percent, an acid value not 0.94 gram per cubic centimeter) and 5. exceeding 10 mg KOH/gm, and a melting range 2. At levels not to exceed 0.1 percent by weight of polycarbonate resins of 85 °C to 110 °C (185 °F to 230 °F). complying with § 177.1580 of this chapter. 3. At levels not to exceed 0.2 percent by weight of polystyrene and 0.3 percent by weight of rubber–modified polystyrene complying with § 177.1640 of this chapter. 4. At levels not to exceed 0.15 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, and 3.6 (where the polyethylene component has a density less than 0.94 gram per cubic centimeter). 5. At levels not to exceed 0.1 percent by weight of repeated use rubber articles complying with § 177.2600 of this chapter. 2,4-Di-tert-butylphenyl-3,5-di-tert-butyl-4-hydroxy- For use only: benzoate (CAS Reg. No. 4221–80–1). 1. At levels not to exceed 0.6 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, item 1.1: (1) when used in single-use articles that contact food of types I, II, IV–B, VI–A, VI–B, VII–B, and VIII, identified in table 1 of § 176.170(c) of this chapter; and (2) when used in repeated-use articles that contact food of types I, II, III, IV, V, VI, VII, VIII, and IX identified in table 1 of § 176.170(c) of this chapter. The additive is used under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.25 percent by weight of olefin polymers having a density of not less than 0.94 gram per cubic centimeter and complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 3.1, and 3.2: (1) when used in single-use articles that contact food of types I, II, IV–B, VI–A, VI– B, VII–B, and VIII, identified in table 1 of § 176.170(c) of this chapter; and (2) when used in repeated-use articles that contact food of types I, II, III, IV, V, VI, VII, VIII, and IX identified in table 1 of § 176.170(c) of this chapter. The additive is used under conditions of use B through H described in table 2 of § 176.170(c) of this chapter.

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Substances Limitations

2,4-Di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2- For use only: hydroxyphenyl)ethyl]phenyl acrylate (CAS Reg. 1. At levels not to exceed 0.2 percent by weight of polypropylene complying No. 123968–25–2). with § 177.1520 of this chapter in contact with food under conditions of use D through G as described in Table 2 of § 176.170(c) of this chapter, except that polypropylene containing the additive at levels not to exceed 0.075 percent by weight may contact food under conditions of use A through H described in Table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 1.0 percent by weight of of styrene block polymers complying with § 177.1810 of this chapter. The additive is used under conditions of use D through G as described in Table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 1.0 percent by weight of polystyrene and rubber modified polystyrene complying with § 177.1640 of this chapter in contact with food under conditions of use D through G as described in Table 2 of § 176.170(c) of this chapter. N,N″–1,2–Ethanediylbis[N–[3–[[4,6- For use only: bis[butyl(1,2,2,6,6-pentamethyl-4- 1. At levels not to exceed 0.06 percent by weight of olefin polymers com- piperidinyl)amino]-1,3,5-triazin-2- plying with § 177.1520(c) of this chapter, items 1.1a, 1.1b, 1.2, or 1.3. yl]amino]propyl]-N′,N″-dibutyl-N′,N″-bis(1,2,2,6,6- The finished polymers may only be used in contact with food of the pentamethyl-4-piperidinyl)-1,3,5-triazine-2,4,6-tri- Types III, IV–A, V, VI–C, VII–A, and IX as described in table 1 of amine] (CAS Reg. No. 106990–43–6). § 176.170(c) of this chapter, and under conditions of use A through H as described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.08 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter. The finished polymers may only be used in contact with food of the Types I, II, IV–B, VI–A, VI–B, VII–B, and VIII as described in table 1 of § 176.170(c) of this chapter, and under conditions of use A through H as described in table 2 of § 176.170(c) of this chapter. Ethylenebis(oxyethylene)-bis-(3-tert-butyl-4-hy- 1. At levels not to exceed 0.3 percent by weight of polystyrene and/or rub- droxy-5-methylhydrocinnamate) (CAS Reg. No. ber modified polystyrene polymers complying with § 177.1640 of this 36443–68–2). chapter. 2. At levels not to exceed 0.3 percent by weight of acrylonitrile-butadiene- styrene copolymers used in accordance with applicable regulations in parts 175, 176, 177, and 181 of this chapter. 3. At levels not to exceed 0.75 percent by weight of polyoxymethylene copolymers used in accordance with § 177.2470 of this chapter. The finished articles shall not be used for foods containing more than 15 percent alcohol. 4. At levels not to exceed 0.25 percent by weight of polyoxymethylene homopolymers used in accordance with § 177.2480 of this chapter. The finished articles shall not be used for foods containing more than 15 percent alcohol. 5. At levels not to exceed 0.2 percent by weight of rigid vinyl chloride plastics prepared from vinyl chloride homopolymers and/or vinly chloride copolymers used in accordance with a prior sanction or applicable regulations in parts 175, 176, and 177 of this chapter. The vinyl chloride copolymers shall contain not less than 50 weight percent of total polymer units derived from vinyl chloride. 6. At levels not to exceed 0.1 percent by weight of vinylidene chloride homopolymers and/or vinylidene chloride copolymers used in accordance with a prior sanction or applicable regulations in parts 175, 176, and 177 of this chapter. The vinylidene chloride copolymers shall contain not less than 50 weight percent of total polymer units derived from vinylidene chloride. 7. In adhesives used in accordance with § 175.105 of this chapter.

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Substances Limitations

2,2′-Ethylidenebis(4,6-di-tert-butylphenol) (CAS For use only: Reg. No. 35958–30–6). 1. At levels not to exceed 0.1 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 3.1, or 3.2 (where the polymers complying with items 3.1 and 3.2 contain primarily polymer units derived from propylene). 2. At levels not to exceed 0.05 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, item 2.1, 2.2, or 2.3. The finished polymers are to be used only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.075 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, item 2.1, 2.2, or 2.3 (where the density of each of these polymers is not less than 0.94 g/cc) and item 3.1 or 3.2 (where each of these polymers contains primarily polymer units derived from ethylene). 4. At levels not to exceed 0.05 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, item 3.3, 3.4, 3.5, or 4. 5. At levels not to exceed 0.1 percent by weight of ethylene vinyl acetate copolymers complying with § 177.1350 of this chapter and under conditions of use C through G described in table 2 of § 176.170(c) of this chapter. 6. At levels not to exceed 0.1 percent by weight of rigid or semirigid polyvinyl chloride and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 7. At levels not to exceed 0.2 percent by weight of acrylonitrile-butadiene- styrene copolymers containing less than 30 percent by weight of acrylonitrile and under conditions of use D through G described in table 2 of § 176.170(c) of this chapter. 8. At levels not to exceed 0.1 percent by weight of polystyrene complying with § 177.1640 of this chapter and under conditions of use D through G described in table 2 of § 176.170(c) of this chapter. 9. At levels not to exceed 0.2 percent by weight of rubber-modified polystyrene complying with § 177.1640 of this chapter. 10. In adhesives complying with § 175.105 of this chapter.

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2,2′-Ethylidenebis(4,6-di-tert- For use only: butylphenyl)fluorophosphonite (CAS Reg. No. 1. As provided in § 175.105 of this chapter. 118337–09–0). 2. In all polymers used in contact with food of types I, II, IV–B, VI–A, VI–B, VII–B, and VIII, under conditions of use B through H described in Tables 1 and 2 of § 176.170(c) of this chapter at levels not to exceed 0.25 percent by weight of polymers. 3. In polypropylene complying with § 177.1520(c) of this chapter, item 1.1, in contact with food of types III, IV–A, V, VII–A, and IX, under: (a) Conditions of use B through H described in Tables 1 and 2 of § 176.170(c) of this chapter at levels not to exceed 0.25 percent by weight of the polymer; or (b) Condition of use A, limited to levels not to exceed 0.1 percent by weight of the polymer; provided that the food-contact surface has an average thickness not exceeding 375 micrometers (0.015 inch). 4. In olefin copolymers complying with § 177.1520(c) of this chapter, items 3.1a or 3.2a, and containing not less than 85 percent by weight of polymer units derived from propylene, in contact with food of types III, IV–A, V, VII–A, and IX, and under: (a) Conditions of use C through G, described in Tables 1 and 2 of § 176.170(c) of this chapter, limited to levels no greater than 0.2 percent by weight of the copolymers; or (b) Conditions of use A, B, and H, limited to levels no greater than 0.1 percent by weight of the olefin copolymers; provided that the food-contact surface has an average thickness not exceeding 375 micrometers (0.015 inch). 5. In olefin polymers complying with § 177.1520(c) of this chapter, items 1.2 or 1.3 in contact with food of types III, IV–A, V, VII–A, and IX, under conditions of use A through H, described in Tables 1 and 2 of § 176.170(c) of this chapter at levels not to exceed 0.1 percent by weight of the polymers; provided that the food-contact surface has an average thickness not exceeding 375 micrometers (0.015 inch). 6. In polyethylene complying with § 177.1520(c) of this chapter, items 2.1 or 2.2, having a density of not less than 0.94, in contact with food of types III, IV–A, V, VII–A, and IX, and under: (a) Conditions of use B through H, described in Tables 1 and 2 of § 176.170(c) of this chapter limited to levels not to exceed 0.2 percent by weight of the polymers; or (b) Condition of use A, described in Tables 1 and 2 of § 176.170(c) of this chapter, limited to levels not to exceed 0.1 percent by weight of the polymer; provided that the food-contact surface has an average thickness not exceeding 125 micrometers (0.005 inch). 7. In olefin copolymers complying with § 177.1520(c) of this chapter, items 3.1a, 3.1b, 3.2a, or 3.2b, containing not less than 85 percent by weight of polymer units derived from ethylene and having a density of not less than 0.94, in contact with food of types III, IV–A, V, VII–A, and IX, and under: (a) Conditions of use C through G, described in Tables 1 and 2 of § 176.170(c) of this chapter limited to levels not to exceed 0.2 percent by weight of the copolymers; or (b) Conditions of use A, B, and H, limited to levels not to exceed 0.1 percent by weight of the copolymers; provided that the food-contact surface has an average thickness not exceeding 125 micrometers (0.005 inch). 8. In olefin polymers complying with § 177.1520(c) of this chapter, items 3.1a, 3.1b, 3.2a, or 3.2b containing not less than 85 percent by weight of polymer units derived from ethylene, in contact with food of types III, IV– A, V, VII–A, and IX, under conditions of use A through H, as described in Tables 1 and 2 of § 176.170(c) of this chapter at levels not to exceed 0.1 percent by weight of the copolymer; provided that the food-contact surface has an average thickness not exceeding 75 micrometers (0.003 inch). 9. In polyethylene phthalate polymers complying with § 177.1630 of this chapter in contact with food of types III, IV–A, V, VI–C, VII–A, and IX, and under: (a) Conditions of use B through H, described in tables 1 and 2 of § 176.170(c) of this chapter, limited to levels not to exceed 0.3 percent by weight of the polymers; or (b) Condition of use A with food of types III, IV–A, V, VII–A, and IX, and limited to levels not to exceed 0.1 percent by weight of the polymers; provided that the film thickness does not exceed 875 micrometers (0.035 inch). Hexadecyl 3,5-di-tert-butyl-4-hydroxybenzoate For use only at levels not to exceed 0.5 percent by weight of olefin poly- (CAS Reg. No. 67845–93–6). mers complying with § 177.1520 of this chapter.

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Substances Limitations

Hexamethylenebis (3,5-di-tert-butyl-4- For use only: hydroxyhydrocinnamate) (CAS Reg. No. 35074- 1. As provided in § 177.2470(b)(1) and § 177.2480(b)(1) of this chapter. 77-2). 2. In adhesives complying with § 175.105 of this chapter. 3. At levels not to exceed 1 percent by weight in pressure-sensitive adhesives complying with § 175.125 of this chapter. 4. At levels not to exceed 1 percent by weight in can end cement formulations complying with § 175.300(b)(3)(xxxi) of this chapter. 5. At levels not to exceed 1 percent by weight in side seam cement formulations complying with § 175.300(b)(3)(xxxii) of this chapter. 6. At levels not to exceed 1 percent by weight in petroleum alicyclic hydrocarbon resins, polyamide resins, and terpene resins complying with § 175.320 of this chapter. 7. At levels not to exceed 1 percent by weight in rosin and rosin derivatives when used in accordance with § 176.170(a)(5) of this chapter. 8. At levels not to exceed 1 percent by weight in petroleum alicyclic hydrocarbon resins or their hydrogenated products complying with § 176.170(b)(2) of this chapter. 9. At levels not to exceed 1 percent by weight in terpene resins complying with § 175.300(b)(3)(xi) of this chapter, when such terpene resins are used in accordance with § 176.170(b)(1) of this chapter. 10. At levels not to exceed 1 percent by weight in resins and polymers authorized for use in accordance with § 176.180 of this chapter. 11. At levels not to exceed 1 percent by weight in closures with sealing gaskets complying with § 177.1210 of this chapter. 12. At levels not to exceed 1 percent by weight in rubber articles intended for repeated use complying with § 177.2600 of this chapter. 13. At levels not to exceed 1 percent by weight in petroleum hydrocarbon resin and rosins and rosin derivatives used in accordance with § 178.3800 of this chapter. 14. At levels not to exceed 1 percent by weight in reinforced wax complying with § 178.3850 of this chapter. N,N′-Hexamethylenebis (3,5-di-tert-butyl-4- For use only: hydroxyhydrocinnamamide) (CAS Reg. No. 1. At levels not to exceed 1 percent by weight of nylon resins complying 23128–74–7). with § 177.1500(b) of this chapter, items 1 through 8, that contact food only of the types identified in categories in § 176.170(c) of this chapter, table 1 except VI–A and VI–C. 2. At levels not to exceed 0.75 percent by weight of nylon 12 resins complying with § 177.1500(b) of this chapter, item 9, that contact food only of the types identified in categories in § 176.170(c) of this chapter, table 1, except VI–A and VI–C. 3. At levels not to exceed 0.6 percent by weight of polyester resins complying with § 175.300(b)(3)(vii) of this chapter. 4. At levels not to exceed 0.6 percent by weight of closures with sealing gaskets complying with § 177.1210 of this chapter. 5. At levels not to exceed 0.6 percent by weight of repeated use rubber articles complying with § 177.2600 of this chapter. 6. At levels not to exceed 0.5 percent by weight of polyoxymethylene copolymer complying with § 177.2470 of this chapter. 7. At levels not to exceed 0.5 percent by weight of polyoxymethylene homopolymer complying with § 177.2480 of this chapter. 1,6–Hexanediamine, N, N′-bis(2,2,6,6-tetramethyl- For use only as a stabilizer at levels not to exceed 0.3 percent by weight of 4-piperidinyl)-, polymers with morpholine-2,4,6- olefin polymers complying with § 177.1520(c) of this chapter. The finished trichloro-1,3,5-triazine reaction products, polymers are to contact food only under conditions of use C, D, E, F, and methylated (CAS Reg. No. 193098–40–7). G, as described in Table 2 of § 176.170(c) of this chapter. Provided that the finished food-contact articles have a volume of at least 18.9 liters (5 gallons).

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Substances Limitations

1,6-Hexanediamine, N,N’-bis(2,2,6,6-tetramethyl-4- For use only: piperidinyl)-, polymer with 2,4,6-trichloro-1,3,5- 1. At levels not to exceed 0.5 percent by weight of propylene polymers and triazine, reaction products with N-butyl-1- copolymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, butanamine and N-butyl-2,2,6,6-tetramethyl-4- 3.1a, 3.2a, 3.2b, 3.4, or 3.5. The finished polymers may contact food only piperidinamine (CAS Reg. No. 192268–64–7). of the types identified in § 176.170(c) of this chapter, table 1, under categories I, II, IV–B, VI–A, VI–B, VII–B, and VIII, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.3 percent by weight of propylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 3.1a, 3.2a, 3.2b, 3.4, or 3.5. The finished polymers may contact food only of the types identified in § 176.170(c) of this chapter, table 1, under categories III, IV–A, V, VI–C, VII–A, and IX, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.5 percent by weight of ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or 3.6 (where the density of each of these polymers is at least 0.94 gram per cubic centimeter), or 5. The finished polymers may contact food only of the types identified in § 176.170(c) of this chapter, table 1, under categories I, II, IV–B, VI–A, VI–B, VII–B, and VIII, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 4. At levels not to exceed 0.05 percent by weight of ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or 3.6 (where the density of each of these polymers is at least 0.94 gram per cubic centimeter), or 5. The finished polymers may contact food only of the types identified in § 176.170(c) of this chapter, table 1, under categories III, IV–A, V, VI–C, VII–A, and IX, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 5. At levels not to exceed 0.5 percent by weight of ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, or 3.6 (where the density of each of these polymers is less than 0.94 gram per cubic centimeter), or 5. The finished polymers may contact food only of the types identified in § 176.170(c) of this chapter, table 1, under categories I, II, IV–B, VI–A, VI–B, VII–B, and VIII, and under conditions of use C through G described in table 2 of § 176.170(c) of this chapter. 6. At levels not to exceed 0.01 percent by weight of ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, or 3.6 (where the density of each of these polymers is less than 0.94 gram per cubic centimeter), or 5. The finished polymers may contact food only of the types identified in § 176.170(c) of this chapter, table 1, under categories III, IV–A, V, VI–C, VII–A, and IX, and under conditions of use C through G described in table 2 of § 176.170(c) of this chapter. 2-Hydroxy-4-isooctoxy-benzophenone. Chemical For use only at levels not to exceed 0.5 percent by weight of olefin copoly- Abstracts (CA) name: Methanone, [2-hydroxy-4- mers complying with § 177.1520(c) of this chapter: Items 1.1, 1.2, 1.3, (isooctyloxy) phenyl]phenyl; CA Registry No. 2.1, 2.2, 2.3, 3.1, 3.2, 3.3 or 4: Provided, That the finished polymer con- 330:59–05–1. tacts food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, VII-B and VIII under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter.

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Substances Limitations

2(2′-Hydroxy-5′-methylphenyl)benzotriazole meet- For use only: ing the following specification: melting point 1. As component of nonfood articles complying with § 177.1010 of this 126° –132 °C (258.8° –269.6 °F) (CAS Reg. No. chapter. 2440–22–4). 2. At levels not to exceed 0.25 percent by weight of rigid polyvinyl chloride and/or rigid vinyl chloride copolymers complying with § 177.1980 of this chapter. 3. In polystyrene that complies with § 177.1640 of this chapter and that is limited to use in contact with dry food of Type VIII described in table 1 of § 176.170(c) of this chapter. 4. At levels not to exceed 0.25 percent by weight of polystyrene and/or rubber-modified polystyrene polymers complying with § 177.1640 of this chapter intended to contact nonalcoholic food: Provided, That the finished basic rubber-modified polystyrene polymers in contact with fatty foods shall contain not less than 90 weight percent of total polymer units derived from styrene monomer. 5. At levels not to exceed 0.5 percent by weight of polycarbonate resins complying with § 177.1580 of this chapter. Provided, That the finished polycarbonate resins contact food only of Types I, II, III, IV, V, VI–A, VI– B, VII, VIII, and IX identified in table 1 of § 176.170(c) of this chapter and under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. 6. At levels not to exceed 0.5 percent by weight of ethylene-1,4- cyclohexylene dimethylene terephthalate copolymers complying with § 177.1315 of this chapter and of ethylene phthalate polymers complying with § 177.1630 of this chapter and that contact food only under conditions of use D through G described in table 2, § 176.170(c) of this chapter. 2-Hydroxy-4-n-octoxy-benzophenone ...... For use only at levels not to exceed 0.5 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4: Provided, That the finished polymer contacts food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, IV-B, VII-B, and VIII , and under the conditions of use B through H described in table 2 of § 176.170(c) of this chapter.

4,4′-Isopropylidenediphenol alkyl(C12-C15) For use only at levels not exceeding 1.0 percent by weight in rigid polyvinyl phosphites; the phosphorus content is in the chloride and/or rigid vinyl chloride copolymers complying with range of 5.2–5.6 weight percent. §§ 177.1950, 177.1970 or 177.1980 of this chapter, and used in contact with food, except milk, only under the conditions described in § 176.170(c) of this chapter, table 2, under conditions of use D through G. Magnesium salicylate ...... For use only in rigid polyvinyl chloride and/or in rigid vinyl chloride copolymers complying with § 177.1980 of this chapter: Provided, That total salicylates (calculated as the acid) do not exceed 0.3 percent by weight of such polymers. 2-Methyl-4,6-bis-[(octylthio)methyl] phenol (CAS For use only: Reg. No. 110553–27–0). 1. In adhesives complying with § 175.105 of this chapter. 2. At levels not to exceed 0.5 percent by weight of can-end cements and side-seam cements complying with § 175.300(b)(xxxi) and (xxxii) of this chapter. 3. At levels not to exceed 1 percent by weight of pressure sensitive adhesives complying with § 175.125 of this chapter petrolium alicyclic hydrocarbon resins complying with § 176.170 of this chapter, resins and polymers complying with § 176.180 of this chapter, and closures with sealing gaskets complying with § 177.1210 of this chapter. 4. At levels not to exceed 1.7 percent by weight of the finished rubber products complying with § 177.2600 of this chapter. 5. At levels not to exceed 0.1 percent by weight of petroleum alicyclic hydrocarbon resins complying with § 175.320 of this chapter; rubber-modified polystyrene complying with § 177.1640 of this chapter; and petroleum hydrocarbon resins and rosins and rosins and rosin derivatives complying with § 178.3800 of this chapter. 6. At levels not to exceed 0.2 percent by weight of styrene block polymenrs complying with § 177.1810 of this chapter that contact food of Types I, II, IV–B, VI, VII–B, and VIII described in table 1, § 176.170(c) of this chapter, only under conditions of use C through H described in table 2, § 176.170(c) of this chapter.

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Substances Limitations

2,2′-Methylenebis(4,6-di-tert-butylphenyl)2- For use only at levels not to exceed 0.25 percent by weight of poly- ethylhexyl phosphite (CAS Reg. No. 126050– propylene complying with § 177.1520 of this chapter. The finished poly- 54–2). mers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV–B, VI–B, VII–B, and VIII under conditions of use B through H described in table 2, § 176.170(c) of this chapter, and with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories III, IV–A, V, VI–A, VI–C, VII–A, and IX under conditions of use C through G described in table 2, § 176.170(c) of this chapter. 2,2′-Methylenebis (6-tert-butyl-4-ethylphenol) ...... For use only: 1. In acrylonitrile-butadiene-styrene copolymers at levels not to exceed 0.6 percent by weight of the copolymer. 2. In semirigid and rigid acrylic and modified acrylic plastics complying with § 177.1010 of this chapter at levels not to exceed 0.1 percent by weight of the plastic. 4,4′-Methylenebis (2,6-di-tert-butyl-phenol) ...... For use only: 1. As provided in § 175.105 of this chapter. 2. At levels not to exceed 0.25 percent by weight of petroleum hydrocarbon resins used in compliance with regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter. 3. At levels not to exceed 0.25 percent by weight of terpene resins used in compliance with regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter. 4. At levels not to exceed 0.5 percent by weight of polyethylene complying with § 177.1520 of this chapter: Provided, That the polyethylene end product contacts foods only of the types identified in Categories I, II, IV- B, VI, VII-B, and VIII in table 1, § 176.170(c) of this chapter. 5. At levels not to exceed 0.5 percent by weight of polybutadiene used in rubber articles complying with § 177.2600 of this chapter: Provided, That the rubber end product contacts foods only of the types identified in Cat- egories I, II, IV-B, VI, VII-B, and VIII in table 1, § 176.170(c) of this chapter. 2,2′-Methylenebis(4-methyl-6-tert-butylphenol) ...... For use only: 1. At levels not to exceed 0.1 percent by weight of olefin polymers complying with sec. 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4 used in articles that contact food of the types identified in sec. 176.170(c) of this chapter, table 1, under Categories I, II, IV- B, VI, VII-B, and VIII. 2. At levels not to exceed 1 percent by weight of polyoxymethylene copolymer as provided in sec. 177.2470(b)(1) of this chapter. 3. At levels not to exceed 0.5 percent by weight of polyoxymethylene homopolymer as provided in § 177.2480(b)(1) of this chapter. 2,2′-Methylenebis(4-methyl-6-tert-butylphenol) For use only: monoacrylate (CAS Reg. No. 61167–58–6). 1. At levels not to exceed 0.5 percent by weight of polystyrene and rubber- modified polystyrene complying with § 177.1640 of this chapter. 2. At levels not to exceed 0.5 percent by weight of styrene block ploymers complying with § 177.1810 of this chapter. 3. At levels not to exceed 1 percent by weight of adhesives complying with § 175.105 of this chapter and pressure sensitive adhesives complying with § 175.125 of this chapter. 4. At levels not to exceed 0.5 percent by weight of acrylonitrile-butadiene- styrene copolymers that comply with § 177.1020 of this chapter when used in articles that contact food only under conditions of use E, F, and G as described in table 2, § 176.170 (c) of this chapter. 2,2′-Methylenebis[6-(1-methylcyclo-hexyl)-p-cresol] For use only: 1. As provided in § 177.1210 of this chapter. 2. At levels not to exceed 0.2 percent by weight of polyethylene complying with § 177.1520 of this chapter: Provided, That the finished polyethylene contacts foods only of the type identified in § 176.170(c) of this chapter, table 1, under Categories I, II, VI–B, and VIII. 3. In polyethylene complying with § 177.1520 of this chapter: Provided, That the finished polyethylene contacts foods only of the types identified in § 176.170(c) of this chapter, table 1, under Categories III, IV, V, VI-A, VII, and IX, and only at temperatures not to exceed room temperature: And further provided, That percentage concentration of the antioxidant in the polyethylene, when multiplied by the thickness in inches of the finished polyethylene, shall not be greater than 0.0005. 2,2′-Methylenebis(4-methyl-6-nonylphenol) and For use only in acrylonitrile-butadiene-styrene copolymers used in contact 2,6-bis(2-hydroxy-3-nonyl-5-methyl-benzyl)-p- with nonalcoholic foods. cresol mixtures (varying proportions).

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Substances Limitations

Methyltin-2-mercaptoethyloleate sulfide, which is For use only in rigid poly(vinyl chloride) and rigid vinyl chloride copolymers defined as one or more of the following: complying with §§ 177.1950 and 177.1980 of this chapter, respectively, used in the manufacture of pipes and pipe fittings intended for contact with water in food processing plants, at levels not to exceed: 1. 1.0 percent by weight in pipes, and 2. 2.0 percent by weight in pipe fittings. 1. 9-Octadecenoic acid (Z)-, 2-mercaptoethyl ester, reaction products with dichlorodime thylstannane, sodium sulfide, and trichloromethylstannane (CAS Reg. No. 68442–12–6); 2. Fatty acids, tall oil, 2-mercaptoethyl esters, reaction products with dichlorodimethylstannane, 2-mercaptoethyl decanoate, 2-mercaptoethyl octanoate, sodium sulfide, and trichloromethylstannane (CAS Reg. No. 151436–98–5); or 3. Fatty acids, tall oil, 2-mercaptoethyl esters, reaction products with dichlorodimethylstannane, sodium sulfide, and trichloromethylstannane (CAS Reg. No. 201687–57–2);and which has the following specifications: Tin content (as Sn) 5 to 21 percent by weight; mercaptosulfur content 5 to 13 percent by weight; acid value no greater than 4. Methyltin-2-Mercaptoethyloleate sulfide may also be used with one or more of the following optional substances: 1.1a 2-Mercaptoethyl oleate (CAS Reg. No. 59118–78–4), 1.1b 2-Mercaptoethyl tallate (CAS Reg. No. 68440–24–4), 1.1c 2-Mercaptoethyl octanoate (CAS Reg. No. 57813–59–9), 1.1d 2-Mercaptoethyl decanoate (CAS Reg. No. 68928–33–6), alone or in combination; not to exceed 40 percent by weight of the stabilizer formulation; 2.1 2-Mercaptoethanol (CAS Reg. No. 60–24– 2): Not to exceed 2 percent by weight of the stabilizer formulation. 3.1 Mineral oil (CAS Reg. No. 8012–95–1): Not to exceed 40 percent by weight of the stabilizer formulation. 4.1 Butylated hydroxytoluene (CAS Reg. No. 128–37–0): Not to exceed 5 percent by weight of the stabilizer formulation. The total of the optional substances (1.1a through 4.1) shall not exceed 60 percent by weight of the stabilizer formulation. Nylon 66/610/6 terpolymer (see § 177.1500 of this For use only at levels not to exceed 1.5 percent by weight of chapter for identification) polyoxymethylene homopolymer as provided in § 177.2480 (b)(1) of this chapter. Nylon 612/6 copolymer. (CAS Reg. No. 51733– For use only at levels not to exceed 1.5 percent by weight of 10–9), weight ratio 6/1. polyoxymethylene homopolymer as provided in § 177.2480(b)(1).

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Substances Limitations

Octadecyl 3,5-di-tert-butyl-4- For use only: hydroxyhydrocinnamate (CAS Reg. No. 2082– 1. At levels not exceeding 0.25 percent by weight of olefin polymers com- 79–3). plying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4. 2. As provided in §§ 175.105 and 177.1010(a)(5) of this chapter. 3. At levels not exceeding 0.25 percent by weight of polystyrene and/or rubber-modified polystyrene polymers complying with § 177.1640 of this chapter, except that the finished basic rubber-modified polystyrene polymers in contact with fatty foods shall contain not less than 85 weight percent of total polymer units derived from styrene monomer. 4. At levels not to exceed 0.5 percent by weight of acrylonitrile-butadiene- styrene copolymers used in accordance with prior sanction or regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter. 5. At levels not exceeding 0.25 percent by weight of olefin copolymers complying with § 177.1520(c) of this chapter, items 3.4 and 3.5 as follows: (a) item 3.4, Provided, That the finished copolymer contacts foods only of types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, III, IV–B, VI, VII, VIII, and IX; (b) item 3.5, Provided, That the finished copolymer contacts non-fatty foods only of types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV–B, VI, VII– B, and VIII. 6. At levels not exceeding 0.05 percent by weight of modified semi-rigid and rigid vinyl chloride plastics modified with methacrylate-butadiene-styrene copolymers in accordance with § 178.3790. 7. At levels not exceeding 0.2 percent by weight of rigid polyvinyl chloride. 8. At levels not to exceed 0.3 percent by weight of polycarbonate resins that comply with § 177.1580 and that contact food only under conditions of use E, F, and G described in table 2, § 176.170(c) of this chapter. 9. At levels not exceeding 0.1 percent by weight of ethylene-vinyl acetate copolymers complying with § 177.1350 of this chapter. 10. At levels not to exceed 0.2 percent by weight of nitrile rubber-modified acrylonitrile-methyl acrylate copolymers that comply with § 177.1480 of this chapter when used in articles that contact food only under conditions of use D, E, F, and G described in table 2, § 176.170(c) of this chapter. 11. At levels not exceeding 0.3 percent by weight of styrene block polymers complying with § 177.1810 of this chapter when used in articles that contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV–B, VI, VII–B, and VIII, and under conditions of use D, E, F, and G described in table 2 of § 176.170(c) of this chapter. 12. At levels not exceeding 0.2 percent by weight of vinylidene chloride homopolymers and/or vinylidene chloride copolymers complying with applicable regulations in parts 175, 176, 177, 179, and 181 of this chapter. The vinylidene chloride copolymers shall contain not less than 50 weight percent of total polymer units derived from vinylidene chloride. 13. At levels not exceeding 0.025 percent by weight of chlorinated isobutylene-isoprene copolymers complying with § 177.1420(a)(3) of this chapter. 14. At levels not exceeding 0.5 percent by weight of the finished rubber article complying with § 177.2600 of this chapter.

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Substances Limitations

7-Oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21- For use only: one,2,2,4,4-tetramethyl-,hydrochloride, reaction 1. At levels not to exceed 0.5 percent by weight of olefin polymers com- products with epichlorohydrin, hydrolyzed, po- plying with § 177.1520 of this chapter, items 1.1, 3.1, and 3.2, where the lymerized (CAS Reg. No. 202483–55–4). copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from propylene; in contact with all types of food described in Table 1 of § 176.170 of this chapter, provided that the finished food-contact article will have a capacity of at least 18.9 liters (5 gallons) when in contact with food of types III, IV–A, V, VII– A, and IX, described in Table 1 of § 176.170 of this chapter. 2. At levels not to exceed 0.5 percent by weight of olefin polymers complying with § 177.1520 of this chapter, items 2.1, 2.2, 3.1, and 3.2, having a density of not less than 0.94 gram/milliliter, where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from ethylene; in contact with food only under conditions of use C, D, E, F, and G, described in Table 2 of § 176.170 of this chapter, provided that the finished food-contact article will have a capacity of at least 18.9 liters (5 gallons) when in contact with food of types III, IV–A, V, VII–A, and IX, described in Table 1 of § 176.170 of this chapter. 3. At levels not to exceed 0.3 percent by weight of olefin polymers complying with § 177.1520 of this chapter, items 2.1, 2.2, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, and 4.0, having a density of less than 0.94 gram/milliliter, in contact with food only under conditions of use D, E, F, and G, described in Table 2 of § 176.170 of this chapter, provided that the finished food-contact article will have a capacity of at least 18.9 liters (5 gallons) except that, films and molded articles containing not more than 0.2 percent by weight of the stabilizer may contact aqueous food of types I, II, IV–B, VI, and VIII, described in Table 1 of § 176.170 of this chapter with no restrictions on the amount of food contacted. Oxidized bis (hydrogenated tallow alkyl) amines ..... For use only: 1. At levels not to exceed 0.1 percent by weight of polypropylene polymers complying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 3.1a (density not less than 0.85 gram per cubic centimeter and less than 0.91 gram per cubic centimeter), 3.2b, 3.4, and 3.5. The finished polymers may be used in contact with food types I, II, IV–B, VII–B and VIII described in table 1 of § 176.170(c) of this chapter, under conditions of use B through H described in table 2 of § 176.170(c) of this chapter and with food types III, IV–A, V, VI, VII–A, and IX described in table 1 of § 176.170(c) of this chapter, under conditions of use D through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.075 percent by weight of high-density polyethylene polymers complying with § 177.1520(c) of this chapter, item 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.6 (density not less than 0.94 gram per cubic centimeter), and 5. The finished polymers may be used in contact with food types I, II, IV–B, VII–B and VIII described in table 1 of § 176.170(c) of this chapter, under conditions of use B through H described in table 2 of § 176.170(c) of this chapter, and with food types III, IV–A, V, VI, VII–A and IX described in table 1 of § 176.170(c) of this chapter, under conditions of use D through H described in table 2 of § 176.170(c) of this chapter. 2,2′-Oxamidobis[ethyl 3-(3,5-di-tert-butyl-4- For use only: hydroxyphenyl)propionate] (CAS Reg. No. 1. At levels not to exceed 0.5 percent by weight of polystyrene and rubber- 70331–94–1). modified polystyrene complying with § 177.1640 of this chapter. 2. At levels not to exceed 0.5 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3. 3. At levels not to exceed 0.5 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, 3.4, 3.5, and 4.0 that contact food Types I, II, IV–B, VI, VII–B and VIII described in table 1 of § 176.170(c) of this chapter. 4. At levels not to exceed 0.1 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, and 4.0 that contact food Types III, IV–A, V, VII–A, and IX described in table 1 of § 176.170(c) of this chapter; except that olefin copolymers complying with items 3.1 and 3.2 where the majority of polymer units are derived from propylene may contain the additive at levels not to exceed 0.5 percent by weight. 5. At levels not to exceed 0.1 percent by weight of olefin polymers complying with item 3.4 of § 177.1520(c) of this chapter, that contact food Types III, VII–A, and IX described in table 1 of § 176.170(c) of this chapter; except that olefin copolymers complying with item 3.4 where the majority of the polymer units are derived from propylene may contain the additive at levels not to exceed 0.5 percent by weight.

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Substances Limitations

Pentaerythritol and its stearate ester ...... For use only in rigid polyvinyl chloride and/or in rigid vinyl chloride copolymers complying with § 177.1980 of this chapter: Provided, That the total amount of pentaerythritol and/or pentaerythritol stearate (calculated as free pentaerythritol) does not exceed 0.4 percent by weight of such polymers. N-Phenylbenzenamine reaction products with For use at levels not to exceed 0.5 percent by weight of pressure-sensitive 2,4,4-trimethylpentenes (CAS Reg. No. 68411– adhesives complying with § 175.125 of this chapter. 46–1). Phosphoric acid triesters with triethylene glycol At levels not to exceed 0.1 percent by weight of polyethylene phthalate (CAS Reg. No. 64502–13–2). polymers complying with § 177.1630 of this chapter, such that the polymers contact foods only of Type VI–B described in table 1 of § 176.170(c) of this chapter. Phosphorous acid, cyclic butylethyl propanediol, For use only: 2,4,6-tri-tert-butylphenyl ester (CAS Reg. No. 1. At levels not to exceed 0.2 percent by weight of olefin polymers com- 161717–32–4), which may contain not more plying with § 177.1520(c) of this chapter, items 1.1, 1.2, or 1.3, and items than 1 percent by weight of triisopropanolamine 2.1, 2.2, or 2.3 (where the density of these polymers is not less than 0.94 (CAS Reg. No. 122–20–3). gram per cubic centimeter), and items 3.1 or 3.2, provided that the finished polymer contacts foods of types I, II, and VI–B as described in table 1 of § 176.170(c) of this chapter only under conditions of use B, C, D, E, F, G, and H as described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.1 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, or 1.3, that contact food of types III, IV, V, VI–A, VI–C, VII, VIII, and IX as described in table 1 of § 176.170(c) of this chapter, only under conditions of use C, D, E, F, and G as described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.1 percent by weight of olefin copolymers complying with § 177.1520(c) of this chapter, items 3.1a, 3.1b, 3.2a, or 3.2b, having a density less than 0.94 grams per cubic centimeter, in contact with food only of types III, IV, V, VI–A, VI–C, VII, VIII, and IX and under conditions of use B, C, D, E, F, G, and H as described in tables 1 and 2 of § 176.170(c) of this chapter; provided that the food-contact surface does not exceed 0.003 inch (0.076 mm) in thickness. 4. At levels not to exceed 0.1 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1(a), 3.1(b), 3.1(c), 3.2 (a), or 3.2(b), having a density not less than 0.94 grams per cubic centimeter, in contact with foods only of types III, IV, V, VI–A, VI–C, VII, VIII, and IX identified in Table 1 of § 176.170(c) of this chapter, and under conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter; provided that the food-contact surface does not exceed 0.003 inch (0.076 mm) in thickness. Phosphorous acid, cyclic neopentanetetrayl For use only at levels not to exceed 0.10 percent by weight of olefin poly- bis(2,4-di-tert-butylphenyl) ester (CAS Reg. No. mers complying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 2.1, 26741–53–7) which may contain not more than 2.2, 2.3, 3.1, or 3.2, and limited to use in contact with food only under 1 percent by weight of triisopropanolamine (CAS conditions of use B, C, D, E, F, G, and H described in table 2 of Reg. No. 122–20–3). § 176.170(c) of this chapter. Olefin polymers that contain more than 50 weight-percent of polymer units derived from ethylene shall have a density equal to or greater than 0.94 gram per cubic centimeter. Phosphorous acid, cyclic neopentanetetrayl bis For use only: (2,6-di-tert-butyl-4-methylphenyl)ester (CAS 1. At levels not to exceed 0.25 percent by weight of polypropylene Reg. No. 80693–00–1). homopolymer and copolymers complying with § 177.1520 of this chapter, for use with all food types described in table 1 of § 176.170(c) of this chapter only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.05 percent by weight of polymers complying with § 177.1520(c) of this chapter, item 3.1 or 3.2, and with a maximum thickness of 100 micrometers (0.004 inch) for use with all food types under conditions of use B, C, D, E, F, G, and H described in table 2 of § 176.170(c) of this chapter.

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Substances Limitations

Phosphorous acid, cyclic neopentanetetrayl For use only: bis(2,4-di-tert-butylphenyl)ester (CAS Reg. No. 1. At levels not to exceed 0.86 percent by weight in polyvinyl chloride and/ 26741–53–7). or vinyl chloride copolymers that comply with §§ 177.1950, 177.1960, 177.1970, or 177.1980 of this chapter for use with all food types described in table 1 of § 176.170(c) of this chapter, except those containing more than 15 percent alcohol, under conditions of use B, C, D, E, F, G, and H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.25 percent by weight of polycarbonate resins that comply with § 177.1580 of this chapter for use with all food types described in table 1 of § 176.170(c) of this chapter, except those containing more than 15 percent alcohol, under conditions of use B, C, D, E, F, G, and H described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.05 percent by weight in olefin polymers complying with § 177.1520(c) of this chapter, item 3.1, that contain more than 50 weight percent of polymer units derived from ethylene and whose density is less than 0.94 gram per cubic centimeter. The average thickness of such polymers intended for use in contact with food types V and VII–A described in table 1 of § 176.170(c) of this chapter shall not exceed 80 micrometers (0.003 inch). Poly(1,4-cyclohexylenedimethylene-3,3′- For use only: thiodipropionate) partially terminated with stearyl 1. In polypropylene complying with § 177.1520(c) of this chapter, item 1.1, alcohol and produced when approximately equal and used in contact with nonfatty, nonalcoholic food. moles of 1,4-cyclohexanedimethanol and 3,3′- 2. At levels not to exceed 0.5 percent by weight of polypropylene complying thiodipropionic acid are made to react in the with § 177.1520(c) of this chapter, item 1.1, and used in contact with presence of stearyl alcohol so that the final fatty, nonalcoholic food. The average thickness of such polymers in the product has an average molecular weight in the form in which they contact fatty nonalcoholic food shall not exceed 0.005 range of 1,800–2,200, as determined by vapor inch. pressure osmometry, and has a maximum acid value of 2.5. Poly[(1,3-dibutyldistannthianediylidene)-1,3-dithio] For use only at levels not to exceed 0.2 by percent weight in polyvinyl chlo- having the formula [C8H18Sn2S3]n (where n aver- ride resin where such resin constitutes not less than 98.7 percent of a ages 1.5–2) and produced so as to meet the fol- finished semirigid or rigid polyvinyl chloride food-contact surface, pro- lowing specifications: Softening point, 130–145 vided that the finished food-contact article is employed only to package °C; volatile components at 150 °C, less than 1.0 meat, cheese, and food Types I, VIII, and IX as described in table 1 of percent; sulphur (sulfide) content in the range § 176.170(c) of this chapter. The finished food-contact article containing 20.5–22.0 percent; tin content in the range this stabilizer, when extracted with refined cottonseed oil at 120 °F for 48 52.0–53.2 percent. hours, using a volume-to-surface ratio of 2 milliliters per square inch of surface tested, shall yield tin (Sn) not to exceed 0.0005 milligram per square inch of food-contact surface. Poly[(6-morpholino-s-triazine-2,4-diyl)[(2,2,6,6- For use only: tetramethyl-4-piperidyl)imino]hexamethylene 1. At levels not to exceed 0.3 percent by weight of polypropylene complying [(2,2,6,6-tetramethyl-4-piperidyl)imino]] (CAS with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3, and of ethyl- Reg. No. 82451–48–7). ene polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.3, and 3.1, whose specific gravity is not less than 0.94. The finished polymers are to contact food only under conditions of use D, E, F, and G described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.3 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.3, and 3.1, whose specific gravity is less than 0.94, and of olefin polymers complying with items 3.3., 3.4, 3.5, and 4.0. The finished polymers are to contact food in articles having a volume of at least 18.9 liters (5 gallons) only under conditions of use D, E, F, and G described in table 2 of § 176.170(c) of this chapter. Poly[[6-[(1,1,3,3-tetramethybutyl) amino]-s-triazine- For use only: 2,4-diyl][2,2,6,6-tetramethyl-4- 1. At levels not to exceed 0.3 percent by weight of polypropylene complying piperidyl)imino]hexamethylene[(2,2,6,6- with § 177.1520 of this chapter. tetramethyl-4-piperidyl)imino]] (CAS Reg. No. 2. At levels not to exceed 0.2 percent by weight of polyethylene complying 70624–18–9). with § 177.1520 of this chapter, that has a density equal to or greater than 0.94 gram per cubic centimeter. 3. At levels not to exceed 0.3 percent by weight of polyethylene that has a density less than 0.94 gram per cubic centimeter complying with § 177.1520 of this chapter, items 2.1, 2.2, and 2.3, and of olefin polymers and copolymers complying with items 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, and 4. The finished polymers are to contact food only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter, and when contacting fatty foods of Types III, IV–A, V, VII–A, and IX described in table 1 of § 176.170(c) of this chapter, the finished articles are to have a volume of at least 18.9 liters (5 gallons).

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Substances Limitations

Potassium bromide and either cupric acetate or For use at levels not exceeding 0.18 percent potassium bromide and 0.005 cupric carbonate. percent copper as cupric acetate or cupric carbonate by weight of nylon 66 resins complying with § 177.1500 of this chapter; the finished resins are used or are intended to be used to contain foods during oven baking or oven cooking at temperatures above 250 °F. The average thickness of such resins in the form in which they contact food shall not exceed 0.0015 inch. 1,3-propanediamine, N,N-1,2-ethanediylbis-, poly- For use only: mer with 2,4,6-trichloro-1,3,5-triazine, reaction 1. At levels not to exceed 0.3 percent by weight of polypropylene complying products with N-butyl-2,2,6,6-tetramethyl-4- with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3. piperidinamine (CAS Reg. No. 136504–96–6). 2. At levels not to exceed 0.2 percent by weight of olefin polymers having a density greater than or equal to 0.94 grams per cubic centimeter and complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, and 3.2. 3. At levels not to exceed 0.3 percent by weight of olefin polymers having a density less than 0.94 grams per cubic centimeter and complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, and 4.0. The finished polymers are to contact food only under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter, and when used in contact with fatty foods of Types III, IV–A, V, VII–A, and IX as described in Table 1 of § 176.170(c) of this chapter, the finished articles are to have a volume of at least 18.9 liters (5 gallons). N,N′-1,3-Propanediylbis (3,5-di-tert-butyl-4- For use only at levels not to exceed 0.6 percent by weight of rubber articles hydroxyhydrocinnamamide) (CAS Reg. No. for repeated use complying with § 177.2600 of this chapter. 69851–61–2). Siloxanes and silicones, methyl hydrogen, reaction For use as an ultraviolet (UV) stabilizer only at levels not to exceed 0.33 products with 2,2,6,6-tetramethyl-4-(2- percent by weight of polypropylene complying with § 177.1520(c) of this propenyloxy)piperidine (CAS Reg. No. 182635– chapter, items 1.1a, 1.1b, 1.2, and 1.3, under conditions of use D, E, F, 99–0). and G, as described in Table 2 of § 176.170 of this chapter. Stearoylbenzoylmethane (CAS Reg. No. 58446– For use only at levels not to exceed 0.5 percent by weight of vinyl chloride 52–9) consisting of a mixture of b–diketones homopolymers modified in accordance with § 178.3790(b)(1). The fin- produced by the condensation of acetophenone ished polymers may be used in contact with food containing up to 50 per- and technical methyl stearate.. cent alcohol under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. Styrenated diphenylamine (CAS Reg. No. 68442– For use only in adhesives complying with § 175.105 of this chapter and in 68–2). rubber articles intended for repeated use complying with § 177.2600 of this chapter. Tetradecanoic acid, lithium salt (CAS Reg. No. For use only at levels not to exceed 0.15 percent by weight of poly- 20336–96–3). propylene and polypropylene copolymers complying with § 177.1520(c) of this chapter, items 1.1a, 1.1b, 3.1a, 3.1b, 3.1c, 3.2a, and 3.2b. The finished polymers may only be used in contact with food of Types I, II, IV– B, VI–B, VII–B, and VIII as described in table 1 of § 176.170(c) of this chapter under conditions of use B through H as described in table 2 of § 176.170(c) of this chapter, and with food of Types III, IV–A, V, VI–A, VI–C, VII–A, and IX described in table 1 of § 176.170(c) of this chapter under conditions of use C through G as described in table 2 of § 176.170(c) of this chapter. 2-[[2,4,8,10-Tetrakis(1,1- For use only at levels not to exceed 0.075 percent by weight of olefin co- dimethylethyl)dibenzo[d,f][1,3,2]- polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, dioxaphosphepin-6-yl]oxy]-N,N-bis[2-[[2,4,8,10- 1.3, 2.1, 2.2, or 2.3: Provided, That the density of the olefin polymers tetrakis(1,1- complying with items 2.1, 2.2, or 2.3 is not less than 0.94 gram per cubic dimethylethy- centimeter: And further provided, That the finished polymers contact food l)dibenzo[d,f][1,3,2]dioxaphosphepin-6- only of Types I, II, IV–B, VI–A, VI–B, VII–B, and VIII described in table 1, yl]oxy]ethyl]ethanamine (CAS Reg. No. 80410– of § 176.170(c) of this chapter, under conditions of use B through H de- 33–9). scribed in table 2 of § 176.170(c) of this chapter and food only of Types III, IV–A, V, VI–C, VII–A, and IX described in table 1 of § 176.170(c) of this chapter, under conditions of use C through G described in table 2 of § 176.170(c) of this chapter.

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Substances Limitations

Tetrakis [methylene(3,5- di-tert-butyl-4- For use only: hydroxyhydrocinnamate)] methane (CAS Reg. 1. At levels not to exceed 0.5 percent by weight of all polymers used as in- No. 6683–19–8). direct additives in food packaging, except as specified below. 2. At levels not to exceed 0.1 percent by weight of petroleum wax or synthetic petroleum wax complying with § 176.170(a)(5) of this chapter. 3. At levels not to exceed 1.0 percent by weight of: (a) Pressure sensitive adhesives complying with § 175.125 of this chapter. (b) Can end cement formulations complying with § 175.300(b)(3)(xxxi) of this chapter. (c) Petroleum alicyclic hydrocarbon resins complying with § 175.320(b)(3) of this chapter, § 176.170(b)(2) of this chapter, or their hydrogenated products complying with § 176.170(b)(2) of this chapter. (d) Rosin and rosin derivatives used in accordance with parts 175 through 178 of this chapter. (e) Terpene resins complying with § 175.300(b)(2)(xi) of this chapter when such terpene resins are used in accordance with § 176.170(b) of this chapter. (f) Resins and polymers complying with § 176.180 of this chapter. (g) Closures with sealing gaskets complying with § 177.1210 of this chapter. (h) Polyoxymethylene copolymer as provided in § 177.2470(b)(1) of this chapter. (i) Petroleum hydrocarbon resin complying with § 178.3800. (j) Reinforced wax complying with § 178.3850. 4,4-Thiobis(6-tert-butyl-m-cresol) ...... For use only: 1. As provided in §§ 175.105 and 177.2600 of this chapter. 2. At levels not to exceed 0.25 percent by weight of polyethylene complying with § 177.1520 of this chapter: Provided, That the specific gravity of the polyethylene is not less than 0.926: And further provided, That the finished polyethylene contacts food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, VI–B, and VIII. Thiodiethylene bis(3,5-di-tert-butyl-4- For use only: hydroxyhydrocinnamate) (CAS Reg. No. 41484- 1. In adhesives complying with § 175.105 of this chapter. 35-9). 2. At levels not to exceed 0.5 percent by weight of pressure-sensitive adhesives complying with § 175.125 of this chapter, petroleum alicyclic hydrocarbon resins complying with § 176.170 of this chapter, resins and polymers complying with § 176.180 of this chapter, closures with sealing gaskets complying with § 177.1210 of this chapter, and finished rubber products complying with § 177.2600 of this chapter. Thiodipropionic acid. 1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4- For use only: hydroxybenzyl) benzene (CAS Reg. No. 1709– 1. At levels not to exceed 0.5 percent by weight of polymers except nylon 70–2). resins identified in § 177.1500 of this chapter. 2. At levels not to exceed 1 percent by weight of nylon resins identified in § 177.1500 of this chapter. Tri(mixed mono-and dinonylphenyl) phosphite (which may contain not more than 1 percent by weight of triisopropanolamine).. 1, 11-(3, 6, 9-Trioxaundecyl) bis-3-(dodecylthio) For use only as provided in § 175.300(b)(3)(xxxi) of this chapter at 4.0 parts propionate (CAS Reg. No. 64253–30–1). per 100 parts rubber. 1,3,5-Tris(3,5-di-tert-butyl-4-hydroxybenzyl)-s-tri- For use only: azine-2,4,6(1H,3H,5H)trione (CAS Reg. No. 1. At levels not to exceed 0.25 percent by weight of polypropylene com- 27676–62–6). plying with § 177.1520 of this chapter. 2. In polyethylene complying with § 177.1520 of this chapter: (a) At levels not to exceed 0.1 weight percent. (b) At levels not to exceed 0.5 weight percent in contact with nonfatty food. 3. At levels not to exceed 0.5 percent by weight of ethylene-propylene-5- ethylidine-2-norbornene terpolymers complying with § 177.1520 of this chapter. The maximum thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 4. At levels not exceeding 0.1 percent by weight of olefin copolymers complying with §177.1520(c) of this chapter, items 3.1, 3.2, 3.3, 3.4, or 3.5. 5. At levels not exceeding 0.25 percent by weight of olefin copolymers complying with § 177.1520(c) of this chapter, items 3.1 and 3.2, and also containing not less than 85 weight percent of polymer units derived from propylene. 6. At levels not to exceed 0.2 percent by weight of olefin polymers complying with § 177.1520(c)(4) of this chapter. The finished polymers may be used in contact with food under conditions of use A through H described in table 2 of § 176.170(c) of this chapter.

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Substances Limitations

1,3,5-Tris(3,5-di-tert-butyl-4-hydro- For use only in contact with nonfatty foods: xyhydrocinnamoyl) hexahydro-s-triazine. 1. At levels not to exceed 0.25 percent by weight of polypropylene complying with § 177.1520 of this chapter. 2. At levels not to exceed 0.1 percent by weight of polyethylene complying with § 177.1520 of this chapter. 3. At levels not to exceed 0.5 percent by weight of ethylene-propylene-5- ethylidine-2-norbornene terpolymers complying with § 177.1520 of this chapter. The maximum thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 1,3,5-Tris(4-tert-butyl-3-hydroxy-2,6-dimethyl- For use only: benzyl)-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione. 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- [CAS Reg. No. 40601–76–1]. plying with § 177.1520 of this chapter, under conditions of use A through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.1 percent by weight of polystyrene and rubber- modified polystyrene that comply with § 177.1640 of this chapter, provided that the finished polystyrene and rubber-modified polystyrene contact food only under the conditions described in § 176.170(c) of this chapter, table 2, under conditions of use E through G.

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Substances Limitations

Tris(2,4-di-tert-butylphenyl)phosphite. (CAS Reg. For use only: No. 31570–04–4). 1. At levels not to exceed 0.5 percent by weight of elastomers used in rubber articles complying with § 177.2600 of this chapter. 2. At levels not to exceed 1 percent by weight of nylon resins complying with § 177.1500 of this chapter: Provided, That the finished polymer contacts food only under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.3 percent by weight of polycarbonate resins complying with § 177.1580 of this chapter. 4. At levels not to exceeds 0.2 percent by weight of polystyrene and rubber-modified polystyrene polymers complying with § 177.1640 of this chapter: Provided, that the finished polymer contacts food only under conditions of use B, C, D, E, F, G, and H described in table 2 of § 176.170(c) of this chapter. 5. At levels not to exceed 0.25 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, item 1.1, 1.2, or 1.3. 6. At levels not to exceed 0.2 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1(a), 3.1(b), 3.1(c), 3.2(a), or 3.2(b). The finished polymers complying with items 2.1, 2.2, or 2.3 having a density less than 0.94 gram per cubic centimeter and a thickness greater than 0.051 millimeter (0.002 inch), either shall have a level of tris(2,4-di-tert-butylphenyl)phosphite that shall not exceed 0.062 milligram per square inch of food-contact surface or shall contact all food types identified in Table 1 of § 176.170(c) of this chapter only under conditions of use E, F, and G described in Table 2 of § 176.170(c) of this chapter. 7. At levels not to exceed 0.2 percent by weight of ethylene-vinyl-acetate copolymers complying with § 177.1350 of this chapter, and that are limited to use in contact with food only under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. The average thickness of such polymers in the form in which they contact fatty food shall not exceed 0.1 millimeter (0.004 inch). 8. At levels not to exceed 0.2 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, item 4. The finished polymers having a thickness greater than 0.051 millimeter (0.002 inch), shall contact food only under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. 9. At levels not to exceed 0.5 percent by weight of acrylic and modified acrylic plastics, semirigid and rigid, complying with § 177.1010 of this chapter. 10. At levels not to exceed 0.1 percent by weight of isobutylene polymers complying with § 177.1420 of this chapter. 11. In adhesives complying with § 175.105 of this chapter. 12. At levels not to exceed 0.5 percent by weight of pressure sensitive adhesives complying with § 175.125 of this chapter. 13. At levels not to exceed 0.5 percent by weight of can end cement formulations complying with § 175.300(b)(3) (xxxi) of this chapter. 14. At levels not to exceed 0.5 percent by weight of side seam cement formulations complying with § 175.300(b)(3) (xxxii) of this chapter. 15. At levels not to exceed 0.5 percent by weight of petroleum alicyclic hydrocarbon resins complying with § 175.320(b)(3) of this chapter. 16. At levels not to exceed 0.5 percent by weight of petroleum alicyclic hydrocarbon resins or their hydrogenated products complying with § 176.170(b) (2) of this chapter. 17. At levels not to exceed 0.5 percent by weight of resins and polymers complying with § 176.180(b) of this chapter. 18. At levels not to exceed 0.5 percent by weight of rosins and rosin derivatives complying with § 176.210(d)(3) of this chapter. 19. At levels not to exceed 0.5 percent by weight of closures with sealing gaskets complying with § 177.1210 of this chapter. 20. At levels not to exceed 0.5 percent by weight of petroleum hydrocarbon resin, and rosins and rosin derivatives complying with § 178.3800(b). 21. At levels not to exceed 0.5 percent by weight of reinforced wax complying with § 178.3850. 22. At levels not to exceed 0.5 percent by weight of olefin copolymers complying with § 177.1520(c) of this chapter, item 3.3. The finished polymers may be used in contact with food under conditions of use A through H described in table 2 of § 176.170(c) of this chapter. 23. At levels not to exceed 0.15 percent by weight of poly-1-butene resins and butene/ethylene copolymers complying with § 177.1570 of this chapter: Provided, that the finished polymer contacts food only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter.

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Substances Limitations

Tris(2-methyl-4-hydroxy-5-tert-butylphenyl)butane For use only: (CAS Reg. No. 1843–03–4). 1. At levels not to exceed 0.25 percent by weight of polymers used as provided in § 176.180 of this chapter. 2. At levels not to exceed 0.25 percent by weight of the following polymers when used in articles that contact food of Types I, II, IV–B, VI–B, VII–B, and VIII described in table 1 of § 176.170(c) of this chapter: Olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4 or complying with other sections in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter; vinyl chloride polymers; and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. 3. At levels not to exceed 0.1 percent by weight of the following polymers when used in articles that contact food of Types III, IV–A, V, VI–A, VI–C, VII–A, and IX described in table 1 of § 176.170(c) of this chapter: Olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4 or complying with other sections in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter; vinyl chloride polymers; and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. 4. As provided in § 175.105 of this chapter. 5. At levels not to exceed 0.2 percent by weight of polystyrene and/or modified polystyrene polymers identified in § 177.1640 of this chapter. 6. At levels not to exceed 0.25 percent by weight of acrylonitrile-butadiene- styrene copolymers used in contact with nonalcoholic foods. 7. At levels not to exceed 1 percent by weight of closure-sealing gasket compositions complying with § 177.1210(b) of this chapter. Zinc dibutyldithiocarbamate (CAS Reg. No. 136– For use only: 23–2). 1. At levels not to exceed 0.2 percent by weight of isobutyleneisoprene copolymers complying with § 177.1420 of this chapter: Provided, That the finished copolymers contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types V, VII, VIII, and IX. 2. At levels not to exceed 0.02 percent by weight of polypropylene polymers complying with § 177.1520(c), item 1.1 of this chapter. Zinc palmitate. Zinc salicylate ...... For use only in rigid polyvinyl chloride and/or in rigid vinyl chloride copolymers complying with § 177.1980 of this chapter: Provided, That total salicylates (calculated as the acid) do not exceed 0.3 percent by weight of such polymers. Zinc stearate. 1 Copies are available from the American Society for Testing and Materials, 1916 Race Street, Philadelphia, Pa. 19103.

[42 FR 14609, Mar. 15, 1977]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 178.2010, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§ 178.2550 4-Hydroxymethyl-2,6-di-tert- § 178.2650 Organotin stabilizers in butylphenol. vinyl chloride plastics. 4-Hydroxymethyl-2,6-di-tert-butyl- The organotin chemicals identified in phenol may be safely used as an anti- paragraph (a) of this section may be oxidant in articles intended for use in safety used alone or in combination, at contact with food, in accordance with levels not to exceed a total of 3 parts the following prescribed conditions: per hundred of resin, as stabilizers in (a) The additive has a solidification vinyl chloride homopolymers and co- point of 140°–141 °C. polymers complying with the provi- (b) The concentration of the additive sions of § 177.1950 or § 177.1980 of this and any other permitted antioxidants chapter and that are identified for use in the finished food-contact article in contact with food of types I, II, III, does not exceed a total of 0.5 milligram IV (except liquid milk), V, VI (except per square inch of food-contact surface. malt beverages and carbonated nonalcoholic beverages), VII, VIII, and IX described in table 1 of § 176.170(c) of this chapter, except for the organotin chemical identified in paragraph (a)(3)

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of this section, which may be used in (3) C10-16-Alkyl mercaptoacetates re- contact with food of types I through IX action products with at temperatures not exceeding 75 °C dichlorodioctylstannane and (167 °F), and further that the organotin trichlorooctylstannane (CAS Reg. No. chemicals identified in paragraphs (a) 83447–69–2) is an organotin chemical (5) and (6) of this section may be used mixture having 10.8 to 11.8 percent by in contact with food of types I through weight of tin (Sn) and having 8.0 to 8.6 IX at temperatures not exceeding 66 °C percent by weight of mercapto sulfur. (150 °F), conditions of use D through G It is made from a mixture of di(n- described in table 2 of § 176.170(c) of this octyl)tin dichloride and (n-octyl)tin chapter, and further that dodecyltin trichloride which has an organotin chemicals identified in paragraph (a)(7) composition that is not less than 95 of this section which may be used in percent by weight di(n-octyl)tin dichlo- contact with food of types I, II, III, IV ride/(n-octyl)tin trichloride, and not (except liquid milk), V, VI (except malt more than 1.5 percent by weight of beverages and carbonated nonalcoholic tri(n-octyl)tin chloride. The alkyl rad- beverages), VII, VIII, and IX described ical in the mercaptoacetate is derived in table 1 of § 176.170(c) of this chapter from a mixture of saturated n-alcohols at temperatures not exceeding 71 °C which has a composition that is not (160 °F), in accordance with the fol- less than 50 percent by weight lowing prescribed conditions: tetradecyl alcohol, and that is not more than 50 percent by weight total of (a) For the purpose of this section, decyl alcohol and/or dodecyl alcohol, the organotin chemicals are those list- and/or hexadecyl alcohol. ed in paragraphs (a) (1), (2), (3), (4), (5), (4) (n-Octyl)tin S,S′S″ tris(isooctyl- (6), and (7) of this section. ′ mercaptoacetate) is an octyltin chem- (1) Di(n-octyl)tin S,S - ical having the formula n- bis(isooctylmercaptoacetate) is an C8H17Sn(SCH2CO2C8H17)3 (CAS Reg. No. octyltin chemical having 15.1 to 16.4 26401–86–5) having 13.4 to 14.8 percent by percent by weight of tin (Sn) and hav- weight of tin (Sn) and having 10.9 to ing 8.1 to 8.9 percent by weight of mer- 11.9 percent by weight of mercapto sul- capto sulfur. It is made from di(n- fur. It is made from (n-octyl)tin tri- octyl)tin dichloride or di(n-octyl)tin chloride. The isooctyl radical in the oxide. The isooctyl radical in the mercaptoacetate is derived from oxo mercaptoacetate is derived from oxo process isooctyl alcohol. The (n- process isooctyl alcohol. Di(n-octyl)tin octyl)tin trichloride has an organotin dichloride has an organotin composi- composition that is not less than 95 tion that is not less than 95 percent by percent by weight of (n-octyl)tin tri- weight of di(n-octyl)tin dichloride and chloride and not more than 5 percent not more than 5 percent by weight of by weight of tri(n-octyl)tin chloride. tri(n-octyl)tin chloride. Di(n-octyl)tin (5) Bis(beta-carbobutoxyethyl)tin oxide has an organotin composition bis(isooctylmercaptoacetate) (CAS that is not less than 95 percent by Reg. No. 63397–60–4) is an estertin weight of di(n-octyl)tin oxide and not chemical having 14.0 to 15.0 percent by more than 5 percent by weight of weight of tin (Sn) and having 7.5 to 8.5 bis[tri(n-octyl)tin] oxide, and/or mono percent by weight of mercapto sulfur. n-octyltin oxide. It is made from bis(beta- (2) Di(n-octyl) tin maleate polymer is carbobutoxyethyl)tin dichloride. The an octyltin chemical having the for- isooctyl radical in the mercaptoacetate mula [(C8H17)2SnC4H2O4]n (where n is be- is derived from oxo process primary tween 2 and 4 inclusive), having 25.2 to octyl alcohols. The bis(beta- 26.6 percent by weight of tin (Sn) and carbobutoxyethyl)tin dichloride has an having a saponification number of 225 organotin composition that is not less to 255. It is made from di(n-octyl)tin di- than 95 percent by weight of bis(beta- chloride or di(n-octyl)tin oxide meet- carbobutoxyethyl)tin dichloride and ing the specifications prescribed for not more than 5 percent by weight of di(n-octyl) tin dichloride or di(n-octyl) bis(beta-carbobutoxyethyltin tri- tin oxide in paragraph (a)(1) of this sec- chloride. The triestertin chloride con- tion. tent of bis(beta-carbobutoxyethyltin)

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dichloride shall not exceed 0.02 percent. cover at least three equilibrium peri- p odic determinations, as follows: (6) Beta-carbobutoxyethyltin (i) The exposure time for the first de- tris(isooctylmercaptoacetate) (CAS termination shall be at least 72 hours Reg. No. 63438–80–2) is an estertin for aqueous solvents, and at least 6 chemical having 13.0 to 14.0 percent by hours for heptane. weight of tin (Sn) and having 10.5 to (ii) Subsequent determinations shall 11.5 percent by weight of mercapto sul- be at a minimum of 24-hour intervals fur. It is made from beta- for aqueous solvents, and 2-hour inter- carbobutoxyethyltin trichloride. The vals for heptane. These tests shall yield isooctyl radical in the mercaptoacetate total octylin stabilizers not to exceed is derived from oxo process primary 0.5 parts per million as determined by octyl alcohol. The beta- analytical method entitled ‘‘Atomic carbobutoxyethyltin trichloride has an Absorption Spectrometric Determina- organotin composition that is not less tion of Sub-part-per-Million Quantities than 95 percent by weight of beta- of Tin in Extracts and Biological Mate- carbobutoxyethyltin trichloride and rials with Graphite Furnace,’’ Analyt- not more than 5 percent total of ical Chemistry, Vol. 49, p. 1090–1093 triestertin chloride and diestertin chlo- (1977), which is incorporated by ref- ride. erence.Copies are available from the (7) The dodecyltin stabilizer is a mix- Center for Food Safety and Applied Nu- ture of 50 to 60 percent by weight of n- trition (HFS–200), Food and Drug Ad- dodecyltin S,S′,S″- ministration, 5100 Paint Branch Pkwy., tris(isooctylmercaptoacetate) (CAS College Park, MD 20740, or available for Reg. No. 67649–65–4) and 40 to 50 percent inspection at the Office of the Federal by weight of di(n-dodecyl)tin S,S′- Register, 800 North Capitol Street, di(isooctylmercaptoacetate) (CAS Reg. NW., suite 700, Washington, DC 20408. No. 84030–61–5) having 13 to 14 percent (iii) Subsequent determinations for by weight of tin (Sn) and having 8 to 9 the dodecyltin mixture described in percent by weight of mercapto sulfur. paragraph (a)(7) of this section shall be It is made from a mixture of dodecyltin at a minimum of 24-hour intervals for trichloride and di(dodecyl)tin dichlo- aqueous solvents and 2-hour intervals ride which has not more than 0.2 per- for heptane. These tests shall yield cent by weight of dodecyltin tri- di(n-octyl)tin S,S′- chloride, not more than 2 percent by bis(isooctylmercaptoacetate), or di(n- weight of dodecylbutyltin dichloride octyl)tin maleate polymer, or (C10-C16)- and not more than 3 percent by weight alkylmercaptoacetate reaction prod- of tri(dodecyl)tin chloride. The ucts with dichlorodioctylstannane and isooctyl radical in the mercaptoacetate trichlorooctylstannane, or n-octyltin is derived from oxo process primary S,S′,S″-tris(isooctylmercaptoacetate), octyl alcohols. tris(isooctylmercaptoacetate) and di(n- (b) The vinyl chloride plastic con- dodecyl)tin tainers, film or panels in the finished bis(isooctylmercaptoacetate) or any form in which they are to contact food, combination thereof, not to exceed 0.5 shall meet the following limitations: parts per million as determined by an (1) The finished plastics intended for analytical method entitled ‘‘Atomic contact with foods of the types listed Absorption Spectrophotometric Deter- in this section shall be extracted with mination of Sub-part-per-Million Quan- the solvent or solvents characterizing tities of Tin in Extracts and Biological those types of foods as determined Materials with Graphite Furnace,’’ An- from table 2 of § 176.170(c) of this chap- alytical Chemistry, Vol. 49, pp. 1090–1093 ter at the temperature reflecting the (1977), which is incorporated by ref- conditions of intended use as deter- erence in accordance with 5 U.S.C. mined therein. Additionally, extrac- 552(a). The availability of this incorpo- tion tests for acidic foods shall be in- ration by reference is given in para- cluded and simulated by 3-percent ace- graph (b)(1)(ii) of this section. tic acid at temperatures specified for (2) In lieu of the tests prescribed in water in table 2 of § 176.170(c) of this paragraph (b) (1) of this section, the chapter. The extraction tests shall finished plastics intended for contact

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with foods only of Types II, V, VI-A List of substances Limitations (except malt beverages), and VI-C may Toluene ...... For use only as a blowing agent ad- be end-tested with food-simulating sol- juvant in polystyrene at a level not vents, under conditions of time and to exceed 0.35 percent by weight temperature, as specified below, where- of finished foamed polystyrene. by such tests shall yield the octyltin residues cited in paragraph (b)(1) of [47 FR 22090, May 21, 1982, as amended at 58 this section not in excess of 0.5 ppm: FR 64895, Dec. 10, 1993]

Tem- perature § 178.3120 Animal glue. Food-simulating solvent Time (degrees (hours) Fahr- Animal glue may be safely used as a enheit) component of articles intended for use Type II ...... Acetic acid, 3 pct ...... 48 135 in producing, manufacturing, packing, Type V ...... Heptane ...... 2 100 processing, preparing, treating, pack- Type VI–A ... Ethyl alcohol, 8 pct ...... 24 120 Type VI–C ... Ethyl alcohol, 50 per- 24 120 aging, transporting, or holding food, cent. subject to the provisions of this section. [42 FR 14609, Mar. 15, 1977, as amended at 47 (a) Animal glue consists of the pro- FR 11847, Mar. 19, 1982; 48 FR 7170, Feb. 18, teinaceous extractives obtained from 1983; 48 FR 42972, Sept. 21, 1983; 48 FR 51612, hides, bones, and other collagen-rich Nov. 10, 1983; 49 FR 8432, Mar. 7, 1984; 50 FR substances of animal origin (excluding 62, Jan. 2, 1985; 50 FR 3510, Jan. 25, 1985; 50 FR 37998, Sept. 19, 1985; 50 FR 47212, Nov. 15, 1985; diseased or rotted animals), to which 54 FR 24898, June 12, 1989] may be added other optional adjuvant substances required in its production Subpart D—Certain Adjuvants and or added to impart desired properties. Production Aids (b) The quantity of any substance employed in the production of animal § 178.3010 Adjuvant substances used in glue does not exceed the amount rea- the manufacture of foamed plastics. sonably required to accomplish the in- The following substances may be tended physical or technical effect nor safely used as adjuvants in the manu- any limitation further provided. facture of foamed plastics intended for (c) Any substance employed in the use in contact with food, subject to any production of animal glue and which is prescribed limitations: the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chap- List of substances Limitations ter conforms with any specification in Azodicarbonamide ..... For use as a blowing agent in pol- such regulation. yethylene complying with item 2.1 in § 177.1520(c) of this chapter at (d) Optional adjuvant substances em- a level not to exceed 5 percent by ployed in the production of animal glue weight of finished foamed poly- include: ethylene. 1,1-Difluoroethane For use as a blowing agent in poly- (1) Substances generally recognized (CAS Reg. No. 75– styrene. as safe in food. 37–6). Isopentane ...... For use as a blowing agent in poly- (2) Substances subject to prior sanc- styrene. tion or approval for use in animal glue n-Pentane ...... Do. and used in accordance with such sanc- 1,1,2,2-Tetra- For use only as a blowing agent ad- chloroethylene. juvant in polystyrene at a level not tion or approval. to exceed 0.3 percent by weight of (3) Substances identified in this para- finished foamed polystyrene in- graph (d)(3) and subject to such limita- tended for use in contact with food only of the types identified in tions as are provided: § 176.170(c) of this chapter, table 1, under Categories I, II, VI, and VIII.

List of substances Limitations

Alum (double sulfate of aluminum and ammonium, potassium, or sodium). 4-Chloro-3-methylphenol(p-chlorome-tacresol) ...... For use as preservative only.

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List of substances Limitations

Chromium potassium sulfate (chrome alum) ...... For use only in glue used as a colloidal flocculant added to the pulp suspension prior to the sheet- forming operation in the manufacture of paper and paper board. 3,5-Dimethyl-1,3,5,H-tetrahydrothiadia-zine-2-thione ...... For use as preservative only. Disodium cyanodithioimidocarbonate ...... Do. Defoaming agents ...... As provided in § 176.210 of this chapter. Ethanolamine. Ethylenediamine. Formaldehyde ...... For use as a preservative only. Potassium N-methyldithiocarbamate ...... Do. Potassium pentachlorophenate ...... Do. Rosins and rosin derivatives ...... As provided in § 178.3870. Sodium chlorate. Sodium dodecylbenzenesulfonate. Sodium 2-mercaptobenzothiazole ...... For use as preservative only. Sodium pentachlorophenate ...... Do. Sodium o-phenylphenate ...... Do. Zinc dimethyldithiocarbamate ...... Do. Zinc 2-mercaptobenzothiazole ...... Do.

(e) The conditions of use are as fol- food-contact materials subject to the lows: provisions of this section: (1) The use of animal glue in any substance or article that is the subject of Substances Limitations a regulation in this subpart conforms Zinc hydroxy For use only as a component of resinous with any specifications or limitations phosphite and polymeric food-contact coatings in- prescribed by such regulation for the (CAS Reg. tended for repeated use in contact with No. 55799– dry foods. finished form of the substance or arti- 16–1). cle. (2) It is used as an adhesive or compo- [50 FR 21835, May 29, 1985] nent of an adhesive in accordance with the provisions of § 175.105 of this chap- § 178.3130 Antistatic and/or anti- ter. fogging agents in food-packaging (3) It is used as a colloidal flocculant materials. added to the pulp suspension prior to The substances listed in paragraph the sheet-forming operation in the (b) of this section may be safely used as manufacture of paper and paperboard. antistatic and/or antifogging agents in (4) It is used as a protective colloid in food-packaging materials, subject to resinous and polymeric emulsion coat- the provisions of this section: ings. (a) The quantity used shall not exceed the amount reasonably required § 178.3125 Anticorrosive agents. to accomplish the intended technical The substances listed in this section effect. may be used as anticorrosive agents in (b) List of substances:

List of substances Limitations

N-Acyl sarcosines where the acyl group is lauroyl, oleoyl, or For use only: derived from the combined fatty acids of coconut oil. 1. As antistatic and/or antifogging agent at levels not to exceed a total of 0.15 pct by weight of polyolefin film used for packaging meat, fresh fruits, and fresh vegetables. The average thickness of such polyolefin film shall not exceed 0.003 inch. 2. As antistatic and/or antifogging agent at levels not to exceed a total of 0.15 pct by weight of ethylene-vinyl acetate copolymer film complying with § 177.1350 of this chapter and used for packaging meat, fresh fruits, fresh vegetables, and dry food of Type VIII described in table 1 of § 176.170(c) of this chapter. The average thickness of such ethylene-vinyl acetate copolymer film shall not exceed 0.003 inch when used for packaging meat, fresh fruits, and fresh vegetables. Alpha-(Carboxymethyl)-omega-(tetradecyloxy)polyoxyethylene) For use only as an antistatic and/or antifogging agent at levels not to exceed 0.2 pct by weight in polyolefin film not exceeding 0.001 inch thickness.

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List of substances Limitations

Alkyl mono- and disulfonic acids, sodium salts (produced from For use only: n-alkanes in the range of C10-C18 with not less than 50 per- 1. As antistatic agents at levels not to exceed 0.1 percent by cent C14-C16). weight of polyolefin films that comply with § 177.1520 of this chapter: Provided, that the finished olefin polymers contact foods of Types I, II, III, IV, V, VIA, VIB, VII, VIII, and IX described in table 1 of § 176.170(c) of this chapter, and under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. 2. As antistatic agents at levels not to exceed 3.0 percent by weight of polystyrene or rubber-modified polystyrene complying with § 177.1640(c) of this chapter under conditions of use B through H described in table 2 of § 176.170(c) of this chapter.

Aluminum Borate ((9Al2O3)·2(B2O3), CAS Reg. No. 11121–16– For use only: 7) produced by reaction between aluminum oxide and/or alu- 1. At levels not to exceed 1 percent by weight of poly- minum hydroxide with boric acid and/or metaboric acid at propylene films complying with § 177.1520(c) of this chapter, temperatures in excess of 1000 °C. item 1.1, of polyethylene films complying with § 177.1520(c) of this chapter, items 2.1 and 2.2 and having a density greater than 0.94 gram per cubic centimeter, and of polyolefin copolymer films complying with § 177.1520(c) of this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b). The finished polymers may be used in contact with all food types identified in Table 1 of § 176.170(c) of this chapter, under conditions of use A through H as described in Table 2 of § 176.170(c) of this chapter. The thickness of the films shall not exceed 0.005 inch. 2. At levels not to exceed 2 percent by weight of polypropylene films complying with § 177.1520(c) of this chapter, item 1.1, of polyethylene films complying with § 177.1520(c) of this chapter, items 2.1 and 2.2 and having a density greater than 0.94 gram per cubic centimeter, and of polyolefin copolymer films complying with § 177.1520(c) of this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b). The finished polymers may be used in contact with all food types identified in Table 1 of § 176.170(c) of this chapter under conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter. The thickness of the films shall not exceed 0.005 inch.

N,N-Bis(2-hydroxyethyl)alkyl(C12-C18)amine ...... For use only as an antistatic agent at levels not to exceed 0.1 pct by weight of polyolefin food-contact films.

N,N-bis(2-hydroxyethyl)alkyl (C13-C15) amine (CAS Reg. No. For use only: 70955–14–5). 1. As an antistatic agent at levels not to exceed 0.2 percent by weight in molded or extruded high-density polyethylene (having a density ≥0.95 g/cm3 and polypropylene containers that contact food only of the types identified in § 176.170(c) of this chapter, Table 1, under types I, VI–B, VII–B, and VIII, under the conditions of use E through G described in Table 2 of § 176.170(c) of this chapter, provided such foods have a pH above 5.0. 2. As an antistatic agent at levels not to exceed 0.1 percent by weight in molded or extruded polypropylene homopolymers and copolymers that contact food only of the types identified in § 176.170(c) of this chapter, Table 1, under Types II, III, IV, V, VII–A, and IX, under the conditions of use C through G described in Table 2 of § 176.170(c) of this chapter.

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List of substances Limitations

N,N-Bis(2-hydroxyethyl) alkylamine, where the alkyl groups For use only: (C1-C18) are derived from tallow. 1. As an antistatic agent at levels not to exceed 0.15 pct by weight in molded or extruded polyethylene containers that contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, IV-B, VI-B, VII-B, and VIII, under the conditions of use E through G described in table 2 of § 176.170(c) of this chapter provided such foods have a pH above 5.0. 2. As an antistatic agent at levels not to exceed 0.10 mg. per square inch of food-contact surface in vinylidene chloride copolymer coatings complying with § 175.320, § 177.1200, or § 177.1630 of this chapter, provided that such coatings contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, IV, VII, VIII, and IX under the conditions of use E through G described in table 2 of § 176.170(c) of this chapter. The finished copolymers shall contain at least 70 weight pct of polymer units derived from vinylidene chloride; and shall contain not more than 5 weight pct of total polymer units derived from acrylamide, acrylic acid, fumaric acid, itaconic acid, methacrylic acid, octadecyl methacrylate, and vinyl sulfonic acid. N,N-Bis(2-hydroxyethyl)dodecanamide produced when For use only: diethanolamine is made to react with methyl laurate such 1. As an antistatic agent at levels not to exceed 0.5 percent by that the finished product: Has a minimum melting point of 36 weight of molded or extruded polyethylene containers in- °C; has a minimum amide assay of 90 percent; contains no tended for contact with honey, chocolate syrup, liquid sweet- more than 2 percent by weight of free diethanolamine; and eners, condiments, flavor extracts and liquid flavor con- contains no more than 0.5 percent by weight of N,N, bis(2- centrates, grated cheese, light and heavy cream, yogurt, and hydroxyethyl)piperazine, as determined by paper chroma- foods of Type VIII as described in table 1 of § 176.170(c) of tography method. this chapter. 2. As an antistatic agent at levels not to exceed 0.2 percent by weight in polypropylene films complying with § 177.1520 of this chapter, and used in contact with food of Types I, II, III, IV, V, VI–B, VII, VIII, and IX described in table 1 of § 176.170(c) of this chapter, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. The average thickness of such polypropylene film shall not exceed 0.001 inches (30 micrometers). N,N-Bis(2-hydroxyethyl) dodecanamide produced when For use only as an antistatic agent at levels not to exceed 0.5 diethanolamine is made to react with methyl laurate such percent by weight of molded or extruded polyethylene con- that the finished product: Has a minimum melting point of 36 tainers intended for contact with honey, chocolate syrup, liq- °C; has a minimum amide assay of 90 percent; contains no uid sweeteners, condiments, flavor extracts and liquid flavor more than 2 percent by weight of free diethanolamine; and concentrates, grated cheese, light and heavy cream, yogurt, contains no more than 0.5 percent by weight of N,N′-bis(2- and foods of Type VIII as described in table 1 of hydroxyethyl) piperazine, as determined by paper chroma- § 176.170(c) of this chapter. tography method. N,N-Bis(2-hydroxyethyl) octadecylamine, Chemical Abstracts For use only as an antistatic agent at levels not to exceed 0.45 Service Registry No. 10213–78–2, N-(2-hydroxyethyl)-N- percent by weight in polypropylene films complying with octadecylglycine (monosodium salt), Chemical Abstracts § 177.1520 of this chapter, and used for packaging food of Service Registry No. 66810–88–6, and N,N-Bis(2-hydroxy- Types I, II, III, IV, V, VI–B, VII, VIII, and IX described in table ethyl)-N-(carboxymethyl) octadecanaminum hydroxide (inner 1 of § 176.170(c) of this chapter, and under conditions of use salt), Chemical Abstracts Service Registry No. 24170–14–7, B through H described in table 2 of § 176.170(c). The aver- as the major components of a mixture prepared by reacting age thickness of such polypropylene film shall not exceed ethylene oxide with octadecylamine and further reacting this 0.002 inch. product with sodium monochloroacetate and sodium hydroxide, such that the final product has: A nitrogen content of 3.3–3.8 percent; a melting point of 42°–50 °C; and a pH of 10.0–11.5 in a 1 percent by weight aqueous solution. a-n-Dodecanol-omega-hydroxypoly (oxyethylene) produced by For use only as an antistatic agent at levels not to exceed 0.2 the condensation of 1 mole of n-dodecanol with an average pct by weight in low-density polyethylene film having an av- of 9.5 moles of ethylene oxide to form a condensate having erage thickness not exceeding 0.005 inch. a hydroxyl content of 2.7 to 2.9 pct and having a cloud point of 80 °C to 92 °C in 1 pct by weight aqueous solution. Glycerol ester mixtures of ricinoleic acid, containing not more As an antifogging agent at levels not exceeding 1.5 pct by than 50 percent monoricinoleate, 45 pct diricinoleate, 10 pct weight of permitted plasticized vinyl chloride homo-and/or triricinoleate, and 3.3 pct free glycerine. copolymers. N-Methacryloyloxyethyl-N, N-dimethylammonium-a-N-methyl For use only as an antistatic agent at levels not to exceed 0.2 carboxylate chloride sodium salt, octadecyl methacrylate, percent by weight of polyolefin films that contact foods under ethyl methacrylate, cyclohexyl methacrylate, N-vinyl-2- the conditions of use B through H described in table 2 of pyrrolidone copolymer (CAS Reg. No. 66822–60–4). § 176.170(c) of this chapter. The average thickness of such polyolefin film shall not exceed 0.02 centimeter (0.008 inch).

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List of substances Limitations

Octadecanoic acid 2-[2-hydroxyethyl) octadecylamino]ethyl For use only as an antistatic agent at levels such that the ester (CAS Reg. No. 52497–24–2), (octadecylimino) diethyl- product of film thickness in microns times the weight percent ene distearate (CAS Reg. No. 94945–28–5), and octadecyl additive does not exceed 16, in polypropylene films com- bis(hydroxyethyl)amine (CAS Reg. No. 10213–78–2), as the plying with § 177.1520(c)1.1 of this chapter, and used for major components of a mixture prepared by reacting ethyl- packaging food (except for food containing more than 8 per- ene oxide with octadecylamine and further reacting this prod- cent alcohol) under conditions of use B through H described uct with octadecanoic acid, such that the final product has: a in table 2 of § 176.170(c) of this chapter. maximum acid value of 5 mg KOH/g and total amine value of 86±6 mg KOH/g as determined by a method entitled ‘‘Total Amine Value,’’ which is incorporated by reference. Copies of the method are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Ad- ministration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Wash- ington, DC 20408.

[42 FR 14609, Mar. 15, 1977, as amended at 45 FR 56797, Aug. 26, 1980; 45 FR 85727, Dec. 30, 1980; 46 FR 13688, Feb. 24, 1981; 47 FR 26824, June 22, 1982; 51 FR 28932, Aug. 13, 1986; 56 FR 41457, Aug. 21, 1991; 58 FR 57556, Oct. 26, 1993; 60 FR 54430, Oct. 24, 1995; 60 FR 18351, Apr. 11, 1995; 62 FR 31511, June 10, 1997; 63 FR 38748, July 20, 1998; 64 FR 62585, Nov. 17, 1999]

§ 178.3280 Castor oil, hydrogenated. (a) The quantity used shall not ex- Hydrogenated castor oil may be safe- ceed the amount reasonably required ly used in the manufacture of articles to accomplish the intended technical or components of articles intended for effect. use in contact with food subject to the (b) The additive is used as follows: provisions of this section.

Use Limitations

1. As a lubricant for vinyl chloride polymers used in the manu- For use only at levels not to exceed 4 pct by weight of vinyl facture of articles or components of articles authorized for chloride polymers. food-contact use. 2. As a component of cellophane ...... Complying with § 177.1200 of this chapter. 3. As a component of resinous and polymeric coatings ...... Complying with § 175.300 of this chapter. 4. As a component of paper and paperboard in contact with Complying with § 176.170 of this chapter. aqueous and fatty food. 5. As a component of closures with sealing gaskets for food Complying with § 177.1210 of this chapter. containers. 6. As a component of cross-linked polyester resins ...... Complying with § 177.2420 of this chapter. 7. As a component of olefin polymers complying with For use only at levels not to exceed 2 percent by weight of the § 177.1520 of this chapter. polymer.

[42 FR 14609, Mar. 15, 1977, as amended at 55 FR 8914, Mar. 9, 1990]

§ 178.3290 Chromic chloride com- nor exceed 7 micrograms of chromium plexes. per square inch of closure area. Myristo chromic chloride complex (b) The packaging container which and stearato chromic chloride complex has its closure area treated with the may be safely used as release agents in release agent shall have a capacity of the closure area of packaging con- not less than 120 grams of food per tainers intended for use in producing, square inch of such treated closure manufacturing, packing, processing, area. preparing, treating, packaging, trans- § 178.3295 Clarifying agents for poly- porting, or holding food, subject to the mers. provisions of this section: (a) The quantity used shall not ex- Clarifying agents may be safely used ceed that reasonably required to ac- in polymers that are articles or compo- complish the intended technical effect nents of articles intended for use in

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contact with food, subject to the provisions of this section:

Substances Limitations

Aluminum, hydroxybis[2,4,8,10-tetrakis(1,1-dimethylethyl)-6-hy- For use only as a clarifying agent at levels not to exceed 0.25 droxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxidato]- percent by weight of polypropylene and polypropylene co- (CAS Reg. No. 151841–65–5). polymers complying with § 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2. The finished polymers contact food only of types I, II, IV-B, VI-B, VII-B, and VIII as identified in Table 1 of § 176.170(c) of this chapter, under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter or foods only of types III, IV-A, V, VI-A, VI-C, VII-A, and IX as identified in Table 1 of § 176.170(c) of this chapter, under conditions of use C through G described in Table 2 of § 176.170(c) of this chapter. Bis(p-ethylbenzylidene) sorbitol (CAS Reg. No. 79072–96–1) ... For use only as a clarifying agent at a level not to exceed 0.35 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1a, 1.1b, 3.1a, 3.2a, or 3.2b, where the copolymers complying with items 3.1a, 3.2a, or 3.2b contain not less than 85 weight percent of polymer units derived from propylene. Di(p-tolylidene) sorbitol (CAS Reg. No. 54686–97–4) ...... For use only as a clarifying agent at a level not to exceed 0.32 percent by weight in propylene homopolymer complying with § 177.1520(c) of this chapter, item 1.1, and in olefin copolymers complying with § 177.1520(c) of this chapter, item 3.1 (containing at least 85 weight percent of polymer units derived from propylene), in contact with all food types under conditions of use C through G described in table 2 of § 176.170(c) of this chapter. Dibenzylidene sorbitol (CAS Reg. No. 32647–67–9) formed by For use only as a clarifying agent for olefin polymers com- the condensation of two moles of benzaldehyde with one plying with § 177.1520(c) 1.1, 3.1, and 3.2 of this chapter mole of sorbitol, such that the final product has a minimum under conditions of use C, D, E, F, and G, described in table content of 95 percent dibenzylidene sorbitol. 2 of § 176.170(c) of this chapter at a level not exceeding 0.25 percent by weight of the polymer. Dimethyldibenzylidene sorbitol (CAS Reg. No. 135861–56–2) For use only as a clarifying agent at a level not to exceed 0.4 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 3.1, and 3.2, where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from polypropylene. The finished polymers shall be used in contact with food under conditions of use A through H described in table 2 of § 176.170(c) of this chapter. Polyvinylcyclohexane (CAS Reg. No. 25498–06–0) ...... For use only as a clarfiying agent for polypropylene complying with § 177.1520(c) of this chapter, item 1.1., and in propylene containing copolymers complying with § 177.1520(c) of this chapter, items 3.1 and 3.2, at a level not exceeding 0.1 percent by weight of the polyolefin. Sodium di(p-tert-butylphenyl)phosphate (CAS Reg. No. 10491– For use only as a clarifying agent at a level not exceeding 0.35 31–3). parts per hundred of the resin in olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2 (where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from propylene).

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Substances Limitations

Sodium 2,2′-methylenebis(4,6-di-tert-butylphenyl)phosphate For use only: (CAS Reg. No. 85209–91–2). 1. As a clarifying agent at a level not exceeding 0.30 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2 (where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from polypropylene). The finished polymers contact foods only of types I, II, IV-B, VI-B, VII-B, and VIII as identified in table 1 of § 176.170(c) of this chapter and limited to conditions of use B through H, described in table 2 of § 176.170(c), or foods of all types, limited to conditions of use C through H described in table 2 of § 176.170(c). 2. As a clarifying agent at levels not exceeding 0.10 percent by weight of polypropylene complying with § 177.1520(c) of this chapter, items 1.1(a) or 1.1(b) and of olefin polymers complying with § 177.1520(c) of this chapter, items 3.1(a), 3.1(b), 3.1(c), 3.2(a), or 3.2(b) (where the copolymers contain not less than 85 weight percent of the polymer units derived from polypropylene.) The finished polymers shall be used in contact with foods only under conditions of use A through H described in Table 2 of § 176.170(c) of this chapter. 3. As a clarifying agent at a level not exceeding 0.30 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, item 2.2, where the finished polymer contacts food only of types I, II, IV–B, VI–A, VI–B, and VII–B as identified in Table 1 of § 176.170(c) of this chapter, and limited to conditions of use B through H described in Table 2 of § 176.170(c) of this chapter, or foods of types III, IV–A, V, VI–C, and VII–A as identified in Table 1 of § 176.170(c) of this chapter and limited to conditions of use C through G described in Table 2 of § 176.170(c) of this chapter.

[46 FR 59236, Dec. 4, 1981, as amended at 52 FR 30920, Aug. 18, 1987; 53 FR 30049, Aug. 10, 1988; 54 FR 12432, Mar. 27, 1989; 54 FR 14734, Apr. 12, 1989; 55 FR 52990, Dec. 26, 1990; 56 FR 1085, Jan. 11, 1991; 59 FR 13650, Mar. 23, 1994; 59 FR 25323, May 16, 1994; 61 FR 33847, July 1, 1996; 61 FR 51588, Oct. 3, 1996; 61 FR 65943, Dec. 16, 1996; 63 FR 56789, Oct. 23, 1998; 63 FR 68392, Dec. 11, 1998; 64 FR 26843, May 18, 1999; 65 FR 16316, Mar. 28, 2000]

§ 178.3297 Colorants for polymers. (b) The colorant must be used in accordance with current good manufac- The substances listed in paragraph turing practice, including use levels (e) of this section may be safely used as which are not in excess of those reason- colorants in the manufacture of arti- ably required to accomplish the in- cles or components of articles intended tended coloring effect. for use in producing, manufacturing, (c) Colorants in this section must packing, processing, preparing, treat- conform to the description and speci- ing, packaging, transporting, or hold- fications indicated. If a polymer de- ing food, subject to the provisions and scribed in this section is itself the sub- definitions set forth in this section: ject of a regulation promulgated under (a) The term colorant means a dye, section 409 of the Federal Food, Drug, pigment, or other substance that is and Cosmetic Act, it shall also comply used to impart color to or to alter the with any specifications and limitations color of a food-contact material, but prescribed by that regulation. Extrac- that does not migrate to food in tion testing guidelines to conduct stud- amounts that will contribute to that ies for additional uses of colorants food any color apparent to the naked under this section are available from eye. For the purpose of this section, the term ‘‘colorant’’ includes sub- the Food and Drug Administration free stances such as optical brighteners and of charge from the Center for Food fluorescent whiteners, which may not Safety and Applied Nutrition, (HFS– themselves be colored, but whose use is 200) Food and Drug Administration, intended to affect the color of a food- 5100 Paint Branch Pkwy., College Park, contact material. MD 20740.

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(d) Color additives and their lakes chapter, may also be used as colorants listed for direct use in foods, under the for food-contact polymers. provisions of the color additive regula- (e) List of substances: tions in parts 73, 74, 81, and 82 of this

Substances Limitations

Aluminum. Aluminum hydrate. Aluminum and potassium silicate (mica). Aluminum mono-, di-, and tristearate. Aluminum silicate (China clay). 4-[[5-[[[4-(Aminocarbonyl) phenyl] amino]carbonyl]- 2- For use at levels not to exceed 1 percent by weight of poly- methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3-hy- mers. The finished articles are to contact foods only under droxy-2-naphthalene-carboxamide (C.I. Pigment Red 187, conditions of use B through H described in table 2 of CAS Reg. No. 59487–23–9). § 176.170(c) of this chapter. N-[4-(Aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H- For use at levels not to exceed 1 percent by weight of poly- benzimidazol-5-yl)amino]carbonyl]-2- mers. The finished articles are to contact food only under oxopropyl]azo]benzamide (C. I. Pigment Yellow 181, CAS conditions of use B through H described in table 2 of Reg. No. 74441–05–7). § 176.170(c) of this chapter. Anthra(2,1,9-def:(6,5,10-d′e′f)diisoquinoline-1,3,8,10(2H,9H)- For use at levels not to exceed 1% by weight of polymers. The tetrone (C.I. Pigment Violet 29; CAS Reg. No. 81–33–4). finished articles are to contact food only under conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter. Barium sulfate. Bentonite. Bentonite, modified with 3-dimethyldioctadecylammonium ion. 1,4-Bis[(2,4,6-trimethylphenyl)amino]-9,10-anthracenedione For use at levels not to exceed 0.0004 percent by weight of (CAS Reg. No. 116–75–6). polyethylene phthalate polymers complying with § 177.1630 of this chapter. 3,6-Bis(4-chlorophenyl)-2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4- For use only at levels not to exceed 1 percent by weight of dione (C.I. Pigment Red 254, CAS Reg. No. 84632–65–5). polymers. The finished articles are to contact food only under conditions of use B through H, described in table 2 of § 176.170(c) of this chapter. 4,4′-Bis(4-anilino-6-diethanolamine-a-triazin-2-ylamino)-2,2′-stil- For use only in the textile fibers specified in § 177.2800 of this bene disulfonic acid, disodium salt. chapter. 4,4′-Bis(4-anilino-6-methylethanolamine-a-triazin-2-ylamino)- Do. 2,2′-stilbene disulfonic acid, disodium salt. Burnt umber. Calcium carbonate. Calcium silicate. Calcium sulfate. Carbon black (channel process, prepared by the impingement process from stripped natural gas). 4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-pyrazol-4- For use at levels not to exceed 1.0 percent by weight of the yl]azo]-5-methylbenzenesulfonic acid, calcium salt (1:1); (C.I. finished polymers. The finished articles are to contact food Pigment Yellow 191, CAS Reg. No. 129423–54–7). only under conditions of use B through H as described in table 2 of § 176.170(c) of this chapter. 4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-pyrazol-4- For use at levels not to exceed 0.5 percent by weight of poly- yl]azo]-5-methylbenzenesulfonic acid, diammonium salt (1:2): mers. The finished articles are to contact food under condi- (C.I. Pigment Yellow 191:1, CAS Reg. No. 154946–66–4). tions of use A through H described in Table 2 of § 176.170(c) of this chapter. Chrome antimony titanium buff rutile (C.I. Pigment Brown 24, For use at levels not to exceed 1 percent by weight of poly- CAS Reg. No. 68186–90–3). mers. The finished articles are to contact food only under conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter.

Chromium oxide green, Cr2O3 (C.I. Pigment Green 17, C.I. No. For use only: 77288). 1. In polymers used in contact with food at a level not to exceed 5 percent by weight of the polymer, except as specified below. 2. In olefin polymers complying with § 177.1520 of this chapter. 3. In repeat-use rubber articles complying with § 177.2600 of this chapter; total use is not to exceed 10 percent by weight of rubber articles.

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Substances Limitations

Cobalt aluminate ...... For use only: 1. In resinous and polymeric coatings complying with § 175.300 of this chapter. 2. Melamine-formaldehyde resins in molded articles complying with § 177.1460 of this chapter. 3. Xylene-formaldehyde resins condensed with 4- 4′isopropylidenediphenol-epichlorohydrin epoxy resins complying with § 175.380 of this chapter. 4. Ethylene-vinyl acetate copolymers complying with § 177.1350 of this chapter. 5. Urea-formaldehyde resins in molded articles complying with § 177.1900 of this chapter. 6. At levels not to exceed 5 percent by weight of all polymers except those listed under limitations 1 through 5 of this item. The finished articles are to contact food under conditions of use A through H described in table 2 of § 176.170(c) of this chapter. Copper chromite black spinel (C.I. Pigment Black 28, CAS For use at levels not to exceed 5 percent by weight of poly- Reg. No. 68186–91–4). mers. The finished articles are to contact food only under conditions of use A through H as described in table 2 of § 176.170(c) of this chapter. D&C Red No. 7 and its lakes. Diatomaceous earth. 4,4′-Diamino-[1,1′-bianthracene]-9,9′,10,10′-tetrone (CAS Reg. For use at levels not to exceed 1 percent by weight of poly- No. 4051–63–2). mers. The finished articles are to contact food only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2,9-Dichloro-5,12-dihydroquinone[2,3-b]acridine-7,14-dione (C.I. For use at levels not to exceed 1.0 percent by weight of poly- Pigment Red 202, CAS Reg. No. 3089–17–6). mers. 4,5-Dichloro-2-((5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H- For use only: pyrazol-4- yl)azo)benzenesulfonic acid, calcium salt(1:1), 1. At levels not to exceed 1 percent by weight of polypropylene (C.I. Pigment Yellow 183, CAS Reg. No. 65212–77–3). polymers and copolymers complying with § 177.1520(c) of this chapter, items 1.1a, 1.1b, 1.2, 1.3, 3.1a, 3.1b, 3.1c, 3.2a, 3.2b, 3.4, or 3.5. The finished articles are to contact food only under conditions of use E through G, as described in Table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 1 percent by weight of high density polyethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.1c, 3.2a, 3.2b, 3.6 (density not less than 0.94 grams per cubic centimeter), or 5. The finished articles are to contact food only under conditions of use E through G, as described in Table 2 of § 176.170(c) of this chapter. 5-[(2,3-Dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]- For use at levels not to exceed 1 percent by weight of poly- 2,4,6(1H, 3H, 5H)-pyrimidinetrione (CAS Reg. No. 72102– mers. The finished articles are to contact food only under 84–2). conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2,9-Dimethylanthra(2,1,9-def:6,5,10-d′e′f′)diisoquinoline- For use at levels not to exceed 1 percent by weight of poly- 1,3,8,10(2H,9H)-tetrone (C.I. Pigment Red 179, CAS Reg. mers. The finished articles are to contact food only under No. 5521–31–3). conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter. 3,3′-[(2,5-Dimethyl-1,4-phenylene)bis[imino(1-acetyl-2-oxo-2,1- For use at levels not to exceed 1 percent by weight of poly- ethanediyl)azo]]bis[4-chloro-N-(5-chloro-2-methylphenyl)- mers. The finished articles are to contact food only under benzamide] (CAS Reg. No. 5280–80–8). conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 3,3′-[(2,5-Dimethyl-1,4-phenylene)bis[imino-carbonyl(2-hydroxy- For use at levels not to exceed 1 percent by weight of poly- 3,1-naphthalenediyl) azo]] bis(4-methylbenzoic acid), bis(2- mers. The finished articles are to contact food only under chloroethyl) ester (CAS Reg. No. 68259–05–2). conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2,2′-[1,2-Ethanediylbis(oxy-2,1-phenyleneazo)]bis[N-(2,3- For use at levels not to exceed 1.0 percent by weight of poly- dihydro-2-oxo-1H-benzimidazol-5-yl)]-3-oxo-butanamide (C.I. mers. The finished articles are to contact food only under Pigment Yellow 180, CAS Reg. No. 77804–81–0). conditions of use B through G described in table 2 of § 176.170(c) of this chapter. 2,2′-(1,2-Ethenediyldi-4,1-phenylene) bis(benzoxazole) (CAS For use as an optical brightener for all polymers at a level not Reg. No. 1533–45–5). to exceed 0.025 percent by weight of polymer. The finished polymer shall contact foods only of the types identified in table 1 of § 176.170(c) of this chapter, under categories I, II, IV–B, VI–A, VI–B, VII–B, and VIII at temperatures not to exceed 275 °F.

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Substances Limitations

High-purity furnace black (CAS Reg. No. 1333–86–4) con- For use at levels not to exceed 2.5 percent by weight of the taining total polynuclear aromatic hydrocarbons not to ex- polymer. ceed 0.5 parts per million, and benzo[a]pyrene not to exceed 5.0 parts per billion, as determined by a method entitled ‘‘Determination of PAH Content of Carbon Black,’’ dated July 8, 1994, as developed by the Cabot Corp., which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Office of Premarket Approval (HFS–200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition’s Li- brary, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. Iron oxides. Kaolin-modified, produced by treating kaolin with a reaction For use only in olefin polymers complying with § 177.1520 of product of isopropyl titanate and oleic acid in which 1 mole this chapter at levels not to exceed 40 percent by weight of of isopropyl titanate is reacted with 1 to 2 moles of oleic olefin polymer. acid. The reaction product will not exceed 8 percent of the modified kaolin. The oleic acid used shall meet the requirements specified in § 172.860 of this chapter. Magnesium oxide. Magnesium silicate (talc). Manganese Violet (manganese ammonium pyrophosphate; For use at levels not to exceed 2 percent by weight of poly- CAS Reg. No. 10101–66–3).. mers. The finished articles are to contact food only under conditions of use A through H as described in table 2 of § 176.170(c) of this chapter. Mixed methylated 4,4′-bis(2-benzoxazolyl)stilbenes with the For use as an optical brightener only at levels not to exceed major portion consisting of 4-(2-benzoxazolyl)-4′-(5-methyl-2- 0.05 percent by weight of rigid and semirigid polyvinyl chlo- benzoxazolyl)stilbene (CAS Registry No. 5242–49–9) and ride and not to exceed 0.03 percent by weight in all other lesser portions consisting of 4,4′-bis(5-methyl-2- polymers. The finished food-contact articles shall be used benzoxazolyl)stilbene (CAS Registry No. 2397–00–4) and only under conditions of use D, E, F, and G described in 4,4′-bis(2-benzoxazolyl)stilbene (CAS Registry No. 1533–45– table 2 of § 176.170(c) of this chapter. 5). 7-(2H-Naphtho[1,2-d]triazol-2-yl)-3-phenylcoumarin (CAS Reg. For use as an optical brightener only in: No. 3333–62–8) having a melting point of 250 °C to 251 °C 1. Olefin polymers complying with § 177.1520 of this chapter and a nitrogen content of 10.7 to 11.2 percent. only at levels such that the product of concentration of the optical brightener (expressed in parts per million by weight of the olefin polymer) multiplied by the thickness of the olefin polymer (expressed in thousandths of an inch and limited to no more than 0.400 inch) shall not exceed 500; provided that the level of the brightener shall not exceed 20 parts per million by weight of the olefin polymer, and further that the olefin polymers shall comply with specifications for items 1.1, 2.1, 3.1, 3.3, and 4 of § 177.1520(c) of this chapter. The polymer may be used under the conditions described in § 176.170(c) of this chapter, table 2, under conditions of use E, F, and G. 2. Polyethylene terephthalate specified in § 177.2800(d)(5)(i) of this chapter at a level not to exceed 0.035 percent by weight of the finished fibers. Nickel antimony titanium yellow rutile (C.I. Pigment Yellow 53, For use at levels not to exceed 1 percent by weight of poly- CAS Reg. No. 8007–18–9). mers. The finished articles are to contact food only under conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter. 1,1′-[(6-Phenyl-1,3,5-triazine-2,4-diyl)diimino]bis-9,10- For use at levels not to exceed 0.25 percent by weight of poly- anthracenedione (CAS Reg. No. 4118–16–5). ethylene phthalate polymers that comply with § 177.1630 of this chapter. The finished articles are to contact food only under conditions of use E, F, and G described in table 2, § 176.170(c) of this chapter, except, when such articles are used with food types III, IV–A, and V, described in table 1, § 176.170(c) of this chapter, the finished articles are to contact food only under conditions of use D, E, F, and G. Phthalocyanine blue (C.I. pigment blue 15, 15:1, 15:2, 15:3, and 15:4; C.I. No. 74160; CAS Reg. No. 147–14–8). Phthalocyanine green (C.I. pigment green 7, C.I. No. 74260). C.I. Pigment red 38 (C.I. No. 21120) ...... For use only in rubber articles for repeated use complying with § 177.2600 of this chapter; total use is not to exceed 10 percent by weight of rubber article. Quinacridone red (C.I. Pigment violet 19, C.I. No. 73900). Sienna (raw and burnt). Silica.

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Substances Limitations

2,3,4,5-Tetrachloro-6-cyanobenzoic acid, methyl ester reaction For use only at levels not to exceed 1 percent by weight of products with p-phenyllenediamine and sodium methoxide polymers. The finished articles are to contact food only (CAS reg. No. 106276–80–6). under conditins of use B through H, described in table 2, of § 176.170(c) of this chapter. 4,5,6,7-Tetrachloro-2-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3- For use only at levels not to exceed 1 percent by weight of dioxo-1H-inden-2-yl)-8-quinolinyl]-1H-isoindole-1,3(2H)-dione polymers. The finished articles are to contact food only (C. I. Pigment Yellow 138, CAS Reg. No.30125–47–4). under conditions of use C through H, as described in table 2 of § 176.170(c) of this chapter; provided further that the finished articles shall not be filled at temperatures exceeding 158 °F (70 °C). 2,2′-(2,5-Thiophenediyl)-bis(5-tert-butylbenzoxazole) (CAS Reg. For use as an optical brightener: No. 7128–64–5). 1. In all polymers at levels not to exceed 0.015 percent by weight of the polymer. The finished articles are to contact food only under conditions of use A through H described in table 2 of § 176.170(c) of this chapter. 2. In all polymers at levels not to exceed 0.05 percent by weight of the polymer. The finished articles shall contact foods only of the types identified in table 1 of § 176.170(c) of this chapter, under Categories I, II, IV–B, VI–A, VI–B, VI–C, VII–B, and VIII under conditions of use A through H described in table 2 of § 176.170(c) of this chapter. 3. In adhesives complying with § 175.105 of this chapter and in pressure-sensitive adhesives complying with § 175.125 of this chapter. Titanium dioxide. Titanium dioxide-barium sulfate. Titanium dioxide-magnesium silicate. Ultramarines ...... As identified in § 73.2725 of this chapter. Zinc carbonate ...... For use only: 1. In resinous and polymeric coatings complying with § 175.300 of this chapter. 2. Melamineformaldehyde resins in molded articles complying with § 177.1460 of this chapter. 3. Xylene-formaldehyde resins condensed with 4-4′- isopropylidene diphenol-epichlorohydrin epoxy resins complying with § 175.380 of this chapter. 4. Ethylene-vinyl acetate copolymers complying with § 177.1350 of this chapter. 5. Urea-formaldehyde resins in molded articles complying with § 177.1900 of this chapter. Zinc chromate ...... For use only in rubber articles for repeated use complying with § 177.2600 of this chapter; total use is not to exceed 10 percent by weight of rubber article. Zinc oxide ...... For use only: 1. In resinous and polymeric coatings complying with § 175.300 of this chapter. 2. Melamine-formaldehyde resins in molded articles complying with § 177.1460 of this chapter. 3. Xylene-formaldehyde resins condensed with 4-4′- isopropylidene-diphenol-epichlorohydrin epoxy resins complying with § 175.380 of this chapter. 4. Ethylene-vinyl acetate copolymers complying with § 177.1350 of this chapter. 5. Urea-formaldehyde resins in molded articles complying with § 177.1900 of this chapter. Zinc sulfide ...... For use at levels not to exceed 10 percent by weight.

[48 FR 46775, Oct. 14, 1983]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 178.3297, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§ 178.3300 Corrosion inhibitors used equipment, subject to the provisions of for steel or tinplate. this section. Corrosion inhibitors may be safely (a) The corrosion inhibitors are pre- used for steel or tinplate intended for pared from substances identified in this use in, or to be fabricated as, food con- section and used subject to the limita- tainers or food-processing or handling tions prescribed.

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(b) The following corrosion inhibitors emulsifiers and/or surface-active or adjuvants are used in amounts not agents in the manufacture of articles to exceed those reasonably required to or components of articles intended for accomplish the intended physical or use in producing, manufacturing, pack- technical effect: ing, processing, preparing, treating, (1) Corrosion inhibitors (active ingre- packaging, transporting, or holding dients) used in packaging materials for food, subject to the provisions of this the packaging of steel or tinplate or ar- section. ticles fabricated therefrom: (a) The quantity used shall not ex- List of substances Limitations ceed the amount reasonably required to accomplish the intended technical Dicyclohexylamine and its salts of fatty acids derived from animal effect; and the quantity that may be- or vegetable oil. come a component of food as a result of Dicyclohexylamine nitrite. such use shall not be intended to, nor Morpholine and its salts of fatty acids derived from animal or in fact, accomplish any physical or vegetable oils. technical effect in the food itself. (b) The use as an emulsifier and/or (2) Adjuvants employed in the appli- surface-active agent in any substance cation and use of corrosion inhibitors: or article that is the subject of a regu- List of substances Limitations lation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with Propylene glycol. any specifications and limitations prescribed by such regulation for the fin- § 178.3400 Emulsifiers and/or surface- ished form of the substance or article. active agents. (c) List of substances: The substances listed in paragraph (c) of this section may be safely used as

List of substances Limitations

a-Alkyl-, a-alkenyl-, and a-alkylaryl-omega- For use only at levels not to exceed 0.5 pct by weight of coat- hydroxypoly(oxyethylene) mixture consisting of 30 weight pct ings complying with § 175.320 of this chapter and limited to of a-(2,4,6-triisobutylphenyl)-omega- use as an emulsifier for polyhydric alcohol diesters used as hydroxypoly(oxyethylene) having an average provided in § 178.3770(b). The weight of the finished coating poly(oxyethylene) content of 7 moles and 70 weight pct of a shall not exceed 2 milligrams per square inch of food-contact 1:1 weight ratio mixture of a-(Z)-9-octadecenyl-omega- surface. hydroxypoly(oxyethylene) having an average poly(oxyethylene) content of 18 moles and a-alkyl(C16-C18)- omega-hydroxypoly(oxyethylene) having an average poly(oxyethylene) content of 18 moles. n-Alkylbenzenesulfonic acid (alkyl group consisting of not less For use only as emulsifiers and/or surface active agents as than 95 percent C10 to C16) and its ammonium, calcium, components of nonfood articles complying with §§ 175.300, magnesium, potassium, and sodium salts. 175.320, 175.365, 175.380, 176.170, 176.180, 177.1010, 177.1200, 177.1210, 177.1630, 177.2600, and 177.2800 of this chapter and § 178.3120. Alkyl mono- and disulfonic acids, sodium salts (produced from For use only: n-alkanes in the range of C10-C18 with not less than 50 per- 1. As provided in § 176.170 of this chapter. cent C14-C16). 2. At levels not to exceed 2 percent by weight of polyvinyl chloride and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. 3. As emulsifiers in vinylidene chloride copolymer or homopolymer coatings at levels not to exceed a total of 2.6 percent by weight of coating solids. The finished polymer contacts food only of the Types I, II, III, IV, V, VIA, VIB, VII, VIII, and IX as identified in table 1 of § 176.170(c) of this chapter, and limited to conditions of use E, F, and G described in table 2 of § 176.170 of this chapter. 4. As emulsifiers and/or surface-active agents at levels not to exceed 3.0 percent by weight of polystyrene or rubber-modified polystyrene complying with § 177.1640(c) of this chapter under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. a-Alkyl-omega-hydroxypoly(oxyethylene) produced by condensation of 1 mole of C11-C15 straight-chain randomly substitued secondary alcohols with an average of 7–20 moles of ethylene oxide.

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List of substances Limitations

alpha Olefin sulfonate [alkyl group is in the range of C10-C18 For use only: with not less than 50 percent C14-C16], ammonium, calcium, 1. In acrylonitrile-butadiene copolymers identified in magnesium, potassium, and sodium salts. § 177.2600(c)(4)(i) of this chapter. 2. At levels not to exceed 1 percent by weight of acrylic coatings complying with § 175.300(b)(3)(xx) of this chapter and having a maximum thickness of 0.051 millimeter (0.002 inch). The finished polymers contact food only of the Types V, VIII, and IX as identified in table 1 of § 176.170(c) of this chapter. 3. At levels not to exceed 2 percent by weight of vinyl chloride copolymer coatings having a maximum thickness of 0.051 millimeter (0.002 inch) and complying with § 175.300(b)(3)(xv) of this chapter. The finished polymers contact food only of the Types V, VIII, and IX as identified in table 1 of § 176.170(c) of this chapter. 4. As provided in § 175.105 of this chapter. Alpha-sulfo-omega-(dodecyloxy)poly(oxyethylene) ammonium For use only as an emulsifier at levels not to exceed 0.3 per- salt (CAS Reg. No. 30174–67–5). cent by weight of styrene-butadiene copolymer coatings for paper and paperboard complying with § 176.170 of this chapter. Ammonium salt of epoxidized oleic acid, produced from For use only: epoxidized oleic acid (predominantly dihydroxystearic and 1. As a polymerization emulsifier at levels not to exceed 1.5 acetoxyhydroxystearic acids) meeting the following specifica- pct by weight of vinyl chloride polymers used as components tions: Acid number 160–180, saponification number 210– of nonfood articles complying with §§ 175.105, 175.300, 235, iodine number 2–15, and epoxy groups 0–0.4 percent. 176.170, 176.180, and 177.1210 of this chapter. Such vinyl chloride polymers are limited to polyvinyl chloride and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. 2. As a polymerization emulsifier at levels not to exceed 1.5 pct by weight of vinyl chloride-vinyl acetate copolymers used as components of nonfood articles complying with §§ 175.105, 175.300, 176.170, 176.180, and 177.1210 of this chapter.

Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium For use as a surface active agent as provided in §§ 175.105, salt (also known as butanedioic acid, sulfo-1,4-diisodecyl 175.125, 176.170, and 176.180 of this chapter. ester, ammonium salt [CAS Reg. No. 144093–88–9]).. a-Di-sec-butylphenyl-omega-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of di-sec-butylphenol with an average of 4–14 or 30–50 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4–14 or 30–50; sec-butyl groups are predominantly (90 percent or more) o-, p-substituents. Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294–49– For use only as an emulsifier at levels not to exceed 5 percent 8). by weight of polymers intended for use in coatings. a-Dodecyl-omega-hydroxpoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 103–111 and that are produced by the esterification of the condensation product of 1 mole of n-dodecyl alcohol with 4–4.5 moles of ethylene oxide. a-(p-Dodecylphenyl)-omega-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of dodecylphenol (dodecyl group is a propylene tetramer isomer) with an average of 4–14 or 30–50 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4–14 or 30–50. Naphthalene sulfonic acid-formaldehyde condensate, sodium For use only: salt (CAS Reg. No. 9084–06–4). 1. At levels not to exceed 10 micrograms/in2 (0.16 mg/dm2) in vinylidene chloride copolymer or homopolymer coatings applied to films of propylene polymers complying with § 177.1520 of this chapter. 2. At levels not to exceed 14 micrograms/in2 (0.21 mg/dm2) in vinylidene chloride copolymer or homopolymer coatings applied to films of polyethylene phthalate polymers complying with § 177.1630 of this chapter.

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List of substances Limitations

a-(p-nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 49–59 and that are produced by the esterification of a-(p-nonylphenyl)-omega- hydroxypoly (oxyethylene) complying with the identity prescribed in § 178.3400(c) and having an average poly(oxyethylene) content of 5.5–6.5 moles. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 62–72 and that are produced by the esterification of ′-(p-nonylphenyl)omega- hydroxypoly (oxyethylene) complying with the identity prescribed in § 178.3400(c) and having an average poly(oxyethylene) content of 9–10 moles. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 98–110 and that are produced by the esterification of a-(p-nonylphenyl)-omega- hydroxypoly (oxyethylene) complying with the identity prescribed in § 178.3400(c) and having an average poly(oxyethylene) content of 45–55 moles. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of nonylphenol (nonyl group is a propylene trimer isomer) with an average of 4–14 or 30– 50 moles of ethylene oxide: if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4–14 or 30–50. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) sulfate, ammonium or sodium salt: the nonyl group is a propylene trimer isomer and the poly (oxyethylene) content average 4 moles. Polyethyleneglycol alkyl(C10-C12) ether sulfosuccinate, disodium For use only at levels not to exceed 5 percent by weight of salt (CAS Reg. No. 68954–91–6). total monomers used in the emulsion polymerization of polyvinyl acetate, acrylic, and vinyl/acrylic polymers intended for use as coatings for paper and paperboard. Poly[(methylene-p-nonylphenoxy) poly(oxypropylene)(4–12 For use in coatings at levels not to exceed 1 mg per square moles) propanol] of minimum molecular weight 3500. foot of food-contact surface. Poly(oxypropylene) (45–48 moles) block polymer with For use only as a surface-active agent at levels not to exceed poly(oxyethylene). The finished block polymers meet the fol- 0.5 percent by weight of polyolefin film or polyolefin coatings. lowing specifications: Average molecular weight 11,000– Such polyolefin film and polyolefin coatings shall have an av- 18,000; hydroxyl number 6.2–10.2; ·cloud point above 100 erage thickness not to exceed 0.005 inch and shall be lim- °C. for 10 pct solution. ited to use in contact with foods that have a pH above 5.0 and that contain no more than 8 pct of alcohol. Polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate) meeting the following specifications: Saponification number 40–50, acid number 0–2, hydroxyl number 60–108, oxyethylene content 70–74 pct. Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate) meeting the following specifications: Saponification number 41–52, oxyethylene content 66–70.5 pct. Polysorbate 60 conforming to the identity prescribed in § 172.836 of this chapter. Polysorbate 65 conforming to the identity prescribed in § 172.838 of this chapter. Polysorbate 80 conforming to the identity prescribed in § 172.840 of this chapter. Polysorbate 85 (polyoxyethylene (20) sorbitan trioleate) meeting the following specifications: Saponification number 80– 95, oxyethylene content 46–50 percent. Sodium 1,4-dicylcohexyl sulfosuccinate. Sodium 1,4-dihexyl sulfosuccinate. Sodium 1,4 diisobutyl sulfosuccinate. Sodium dioctyl sulfosuccinate. Sodium 1,4-dipentyl sulfosuccinate. Sodium 1,4-ditridecyl sulfosuccinate. Sodium lauryl sulfate. Sodium monoalkylphenoxybenzenedisulfonate and sodium dialkylphenoxybenzenedisulfonate mixtures containing not less than 70 pct of the monoalkylated product where the alkyl group is C8C16. Sorbitan monolaurate meeting the following specifications. Sa- ponification number 153–170; and hydroxyl number 330–360.

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List of substances Limitations

Sorbitan monooleate meeting the following specifications: Sa- ponification number 145–160, hydroxyl number 193–210. Sorbitan monopalmitate meeting the following specifications: Saponification No. 140–150; and hydroxyl No. 275–305. Sorbitan monostearate conforming to the identity prescribed in § 172.842 of this chapter. Sorbitan trioleate meeting the following specifications: Saponi- fication No. 170–190; and hydroxyl No. 55–70. Sorbitan tristearate meeting the following specifications: Sa- ponification No. 176–188; and hydroxyl No. 66–80. Sulfosuccinic acid 4-ester with polyethylene glycol dodecyl For use only at levels not to exceed 5 percent by weight of ether, disodium salt (CAS Reg. No. 39354–45–5). total monomers used in the emulsion polymerization of polyvinyl acetate, acrylic, and vinyl/acrylic polymers intended for use as coatings for paper and paperboard. Sulfosuccinic acid 4-ester with polyethylene glycol nonylphenyl For use only at levels not to exceed 5 percent by weight of the ether, disodium salt (alcohol moiety produced by condensa- total coating monomers used in the emulsion polymerization tion of 1 mole nonylphenol and an average of 9–10 moles of of polyvinyl acetate and vinyl-acrylate copolymers intended ethylene oxide) (CAS Reg. No. 9040–38–4). for use as coatings for paper and paperboard. a-[p-(1,1,3,3-Tetramethylbutyl)phenyl] omega- hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-(1,1,3,3-tetramethylbutyl) phenol with an average of 4–14 or 30–40 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4–14 or 30–50. Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecyl-sulfosuccinate For use only as a polymerization emulsifier for resins applied to tea-bag material. a-Tridecyl-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 75–85 and that are produced by the esterification of the condensation product of one mole of ‘‘oxo’’ process tridecyl alcohol with 5.5–6.5 moles of ethylene oxide. a-Tridecyl-omega-hydroxypoly (oxyethyl-ene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 58–70 and that are produced by the esterification of the condensation product of one mole of ‘‘oxo’’ process tridecyl alcohol with 9–10 moles of ethylene oxide.

(d) The provisions of this section are styrene intended for use in contact not applicable to emulsifiers and/or with food. surface-active agents listed in (b) They are added to the formulated § 175.105(c)(5) of this chapter and used in polymer prior to extrusion. food-packaging adhesives complying (c) The quantity used shall not ex- with § 175.105 of this chapter. ceed that required to accomplish the [42 FR 14609, Mar. 15, 1977] intended technical effect. EDITORIAL NOTE: For FEDERAL REGISTER ci- § 178.3480 Fatty alcohols, synthetic. tations affecting § 178.3400, see the List of CFR Sections Affected, which appears in the Synthetic fatty alcohols may be safe- Finding Aids section of the printed volume ly used as components of articles in- and on GPO Access. tended for use in contact with food, and in synthesizing food additives and § 178.3450 Esters of stearic and pal- other substances permitted for use as mitic acids. components of articles intended for use The ester stearyl palmitate or in contact with food in accordance palmityl stearate or mixtures thereof with the following prescribed condi- may be safely used as adjuvants in tions: food-packaging materials when used in (a) The food additive consists of fatty accordance with the following pre- alcohols meeting the specifications and scribed conditions: definition prescribed in § 172.864 of this (a) They are used or intended for use chapter, except as provided in para- as plasticizers or lubricants in poly- graph (c) of this section.

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(b) It is used or intended for use as in the synthesis of sodium lauryl sul- follows: fate used in compliance with § 178.3400. (1) As substitutes for the cor- [42 FR 14609, Mar. 15, 1977, as amended at 47 responding naturally derived fatty al- FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, cohols permitted for use as components 1989] of articles intended for use in contact with food by existing regulations in § 178.3500 Glycerin, synthetic. parts 174, 175, 176, 177, 178 and § 179.45 of Synthetic glycerin may be safely this chapter: Provided, That the use is used as a component of articles in- in compliance with any prescribed lim- tended for use in packaging materials itations. for food, subject to the provisions of (2) As substitutes for the cor- this section: responding naturally derived fatty al- (a) It is produced by the hydro- cohols used as intermediates in the genolysis of carbohydrates, and shall synthesis of food additives and other contain not in excess of 0.2 percent by substances permitted for use as compo- weight of a mixture of butanetriols. nents of food-contact articles. (b) It is used in a quantity not to ex- (c) Synthetic fatty alcohols identi- ceed that amount reasonably required fied in paragraph (c)(1) of this section to produce its intended physical or may contain not more than 0.8 weight technical effect, and in accordance percent of total diols as determined by with any limitations prescribed by ap- a method titled ‘‘Diols in Monohydroxy plicable regulations in parts 174, 175, Alcohol by Miniature Thin Layer Chro- 176, 177, 178 and 179 of this chapter. It matography (MTLC),’’ which is incor- shall not be intended to, nor in fact ac- porated by reference. Copies are avail- complish, any direct physical or tech- able from the Center for Food Safety nical effect in the food itself. and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint § 178.3505 Glyceryl tri-(12-acetoxystearate). Branch Pkwy., College Park, MD 20740, or available for inspection at the Office Glyceryl tri-(12-acetoxystearate) of the Federal Register, 800 North Cap- (CAS Reg. No. 139–43–5) may be safely itol Street, NW., suite 700, Washington, used as a component of articles in- DC 20408. tended for use in producing, manufac- (1) Synthetic fatty alcohols. (i) Hexyl, turing, packing, processing, preparing, octyl, decyl, lauryl, myristyl, cetyl, treating, packaging, transporting, or and stearyl alcohols meeting the speci- holding food, subject to the provisions fications and definition prescribed in of this section. § 172.864 of this chapter, except that (a) The additive is applied to the sur- they may contain not more than 0.8 face of calcium carbonate at a level not weight percent total diols. to exceed 1 weight-percent of the total (ii) Lauryl, myristyl, cetyl, and ste- mixture. aryl alcohols manufactured by the (b) The calcium carbonate/glyceryl process described in § 172.864(a)(2) of tri-(12-acetoxystearate) mixture is used this chapter such that lauryl and as an adjuvant in polymers in contact myristyl alcohols meet the specifica- with nonfatty foods at a level not to exceed 20 weight-percent of the poly- tions in § 172.864(a)(1)(i) of this chapter, mer. and cetyl and stearyl alcohols meet the specifications in § 172.864(a)(1)(ii) of this [50 FR 1503, Jan. 11, 1985] chapter. (2) Conditions of use. (i) Synthetic § 178.3520 Industrial starch-modified. fatty alcohols as substitutes for the Industrial starch-modified may be corresponding naturally derived fatty safely used as a component of articles alcohols permitted for use in compli- intended for use in producing, manu- ance with § 178.3910. facturing, packing, processing, pre- (ii) Synthetic lauryl alcohol as a sub- paring, treating, packaging, trans- stitute for the naturally derived lauryl porting, or holding food, subject to the alcohol permitted as an intermediate provisions of this section.

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(a) Industrial starch-modified is iden- an amount reasonably required to tified as follows: achieve the desired functional effect (1) A food starch-modified or starch but in no event in excess of any limita- or any combination thereof that has tion prescribed, with or without subse- been modified by treatment with one of quent treatment as authorized in the reactants hereinafter specified, in § 172.892 of this chapter.

List of reactants Limitations

Ammonium persulfate, not to exceed 0.3 pct. or in alkaline starch not to exceed 0.6 pct.. (4-Chlorobutene-2) trimethylammonium chloride, not to exceed Industrial starch modified by this treatment shall be used only 5 pct. as internal sizing for paper and paperboard intended for food packaging. b-Diethylaminoethyl chloride hydrochloride, not to exceed 4 pct. Dimethylaminoethyl methacrylate, not to exceed 3 pct. Dimethylol ethylene urea, not to exceed 0.375 pct ...... Industrial starch modified by this treatment shall be used only as internal sizing for paper and paperboard intended for food packaging. 2,3-Epoxypropyltrimethylammonium chloride, not to exceed 5 pct. Ethylene oxide, not to exceed 3 pct of reacted ethylene oxide in finished product. Phosphoric acid, not to exceed 6 pct and urea, not to exceed Industrial starch modified by this treatment shall be used only 20 pct. as internal sizing for paper and paperboard intended for food packaging and as surface sizing and coating for paper and paperboard that contact food only of Types IV-A, V, VII, VIII, and IX described in table 1 of § 176.170(c) of this chapter.

(2) A starch irradiated under one of (ii) An electron beam source at a the following conditions to produce maximum energy of 7 million electron free radicals for subsequent graft po- volts of ionizing radiation, maximum lymerization with the reactants listed absorbed dose not to exceed 5.0 in this paragraph (a)(2): megarads. (i) Radiation from a sealed cobalt 60 source, maximum absorbed dose not to exceed 5.0 megarads.

List of reactants Limitations

Acrylamide and [2-(methacryloyloxy) ethyl]trimethylammonium For use only as a retention aid and dry strength agent em- methyl sulfate, such that the finished industrial starch-modi- ployed before the sheet-forming operation in the manufac- fied shall contain: ture of paper and paperboard intended to contact food, and used at a level not to exceed 0.25 pct by weight of the finished dry paper and paperboard fibers. 1. Not more than 60 weight percent vinyl copolymer (of which not more than 32 weight percent is [2- (methacryloyloxy)ethyl] trimethylammonium methyl sulfate). 2. Not more than 0.20 pct residual acrylamide. 3. A minimum nitrogen content of 9.0 pct.

(b) The following adjuvants may be starch-modified,’’ and in the instance used as surface-active agents in the of an industrial starch-modified which processing of industrial starch-modi- is limited with respect to conditions of fied: use, the label of the food additive container shall contain a statement of Polyethylene glycol (400) dilaurate. such limited use. Polyethylene glycol (400) monolaurate. Polyoxyethylene (4) lauryl ether. [42 FR 14609, Mar. 15, 1977, as amended at 42 (c) To insure safe use of the indus- FR 49453, Sept. 27, 1977] trial starch-modified, the label of the food additive container shall bear the name of the additive ‘‘industrial

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§ 178.3530 Isoparaffinic petroleum hy- dure D381–80, ‘‘Standard Test Method for drocarbons, synthetic. Existent Gum in Fuels by Jet Evapo- ration,’’ which are incorporated by ref- Isoparaffinic petroleum hydro- erence. Copies may be obtained from the carbons, synthetic, may be safely used American Society for Testing Materials, in the production of nonfood articles 1916 Race St., Philadelphia, PA 19103, or intended for use in producing, manu- may be examined at the Office of the Fed- facturing, packing, processing, pre- eral Register, 800 North Capitol Street, paring, treating, packaging, trans- NW., suite 700, Washington, DC 20408. porting, or holding food, subject to the (b) Isoparaffinic petroleum hydro- provisions of this section. carbons may contain antioxidants au- (a) The isoparaffinic petroleum hy- thorized for use in food in an amount drocarbons, produced by synthesis from not to exceed that reasonably required petroleum gases consist of a mixture of to accomplish the intended technical liquid hydrocarbons meeting the fol- effect. lowing specifications: (c) Isoparaffinic petroleum hydro- Boiling point 63° –260 °C, as determined by carbons are used in the production of ASTM method D86–82, ‘‘Standard Method nonfood articles. The quantity used for Distillation of Petroleum Products,’’ shall not exceed the amount reason- which is incorporated by reference. Copies ably required to accomplish the in- may be obtained from the American Soci- tended technical effect, and the resid- ety for Testing Materials, 1916 Race St., ual remaining in the finished article Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, shall be the minimum amount reason- 800 North Capitol Street, NW., suite 700, ably attainable. Washington, DC 20408. [42 FR 14609, Mar. 15, 1977, as amended at 47 Ultraviolet absorbance: FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, 260–319 millimicrons—1.5 maximum. 1984] 320–329 millimicrons—0.08 maximum. 330–350 millimicrons—0.05 maximum. Nonvolatile residue 0.002 gram per 100 milli- § 178.3570 Lubricants with incidental liters maximum. food contact. Synthetic isoparaffinic petroleum hydro- Lubricants with incidental food con- carbons containing antioxidants shall meet tact may be safely used on machinery the specified ultraviolet absorbance limits used for producing, manufacturing, after correction for any absorbance due to packing, processing, preparing, treat- the antioxidants. The ultraviolet absorbing, packaging, transporting, or hold- ance shall be determined by the procedure ing food, subject to the provisions of described for application to mineral oil under ‘‘Specifications’’ on page 66 of the this section: ‘‘Journal of the Association of Official Ag- (a) The lubricants are prepared from ricultural Chemists,’’ Vol. 45 (February one or more of the following sub- 1962), which is incorporated by reference, stances: disregarding the last sentence of that pro- (1) Substances generally recognized cedure. For hydrocarbons boiling below 121 as safe for use in food. ° C, the nonvolatile residue shall be deter- (2) Substances used in accordance mined by ASTM method D1353–78, ‘‘Stand- ard Test Method for Nonvolatile Matter in with the provisions of a prior sanction Volatile Solvents for Use in Paint, Var- or approval. nish, Lacquer, and Related Products;’’ for (3) Substances identified in this para- those boiling above 121 °C, ASTM proce- graph (a)(3).

Substances Limitations

Aluminum stearoyl benzoyl hydroxide ...... For use only as a thickening agent in mineral oil lubricants at a level not to exceed 10 pct by weight of the mineral oil. N,N-Bis(2-ethylhexyl)-ar-methyl-1H-benzotriazole-1- For use as a copper deactivator at a level not to exceed 0.1 methanamine (CAS Reg. No. 94270–86–7). percent by weight of the lubricant. BHA. BHT. a-Butyl-omega-hydroxypoly(oxyethylene) poly(oxypropylene) Addition to food not to exceed 10 parts per million. produced by random condensation of a 1:1 mixture by weight of ethylene oxide and propylene oxide with butanol; minimum molecular weight 1,500; Chemical Abstracts Serv- ice Registry No. 9038–95–3.

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Substances Limitations

a-Butyl-omega-hydroxypoly(oxypropylene); minimum molecular Do. weight 1,500; Chemical Abstracts Service Registry No. 9003–13–8. Castor oil ...... Do. Castor oil, dehydrated ...... Do. Castor oil, partially dehydrated ...... Do. Dialkyldimethylammonium aluminum silicate (CAS Reg. No. For use only as a gelling agent in mineral oil lubricants at a 68953–58–2), which may contain up to 7 percent by weight level not to exceed 15 percent by weight of the mineral oil. 1,6-hexanediol (CAS Reg. No. 629–11–8), where the alkyl groups are derived from hydrogenated tallow fatty acids (C14-C18) and where the aluminum silicate is derived from bentonite. Dimethylpolysiloxane (viscosity greater than 300 centistokes) ... Addition to food not to exceed 1 part per million. Di (n-octyl) phosphite (CAS Reg. No. 1809–14–9) ...... For use only as an extreme pressure-antiwear adjuvant at a level not to exceed 0.5 percent by weight of the lubricant. Disodium decanedioate (CAS Reg. No. 17265–14–4) ...... For use only: 1. As a corrosion inhibitor or rust preventative in mineral oil- bentonite lubricants at a level not to exceed 2 percent by weight of the grease. 2. As a corrosion inhibitor or rust preventative only in greases at a level not to exceed 2 percent by weight of the grease. Disodium EDTA (CAS Reg. No. 139–33–3) ...... For use only as a chelating agent and sequestrant at a level not to exceed 0.06 percent by weight of lubricant at final use dilution. Ethoxylated resin phosphate ester mixture consisting of the fol- For use only as a surfactant to improve lubricity in lubricating lowing compounds: fluids complying with this section at a level not to exceed 5 percent by weight of the lubricating fluid. 1. Poly(methylene-p-tert-butyl- phenoxy)poly-(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters (0 to 40 percent of the mixture). The resin is formed by condensation of 1 mole of p-tert- butylphenol with 2 to 4 moles of formaldehyde and subsequent ethoxylation with 4 to 12 moles of ethylene oxide;. 2. Poly(methylene-p-nonylphenoxy) poly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters (0 to 40 percent of the mixture). The resin is formed by condensation of 1 mole of p-nonylphenol with 2 to 4 moles of formaldehyde and subsequent ethoxylation with 4 to 12 moles of ethylene oxide; and. 3. n-Tridecyl alcohol mixture of dihydrogen phosphate and monohydrogen phosphate esters (40 to 80 percent of the mixture; CAS Reg. No. 56831–62–0). Fatty acids derived from animal or vegetable sources, and the hydrogenated forms of such fatty acids. 2-(8-Heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol (CAS For use at levels not to exceed 0.5 percent by weight of the lu- Reg. No. 95–38–5). bricant. Hexamethylenebis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate) For use as an antioxidant at levels not to exceed 0.5 percent (CAS Reg. No. 35074–77–2). by weight of the lubricant. a-Hydro-omega-hydroxypoly (oxyethylene) poly(oxypropylene) Addition to food not to exceed 10 parts per million. produced by random condensation of mixtures of ethylene oxide and propylene oxide containing 25 to 75 percent by weight of ethylene oxide; minimum molecular weight 1,500; Chemical Abstracts Service Registry No. 9003–11–6. 12-Hydroxystearic acid. Isopropyl oleate ...... For use only as an adjuvant (to improve lubricity) in mineral oil lubricants. Magnesium ricinoleate ...... For use only as an adjuvant in mineral oil lubricants at a level not to exceed 10 percent by weight of the mineral oil. Mineral oil ...... Addition to food not to exceed 10 parts per million. N-Methyl-N-(1-oxo-9- octadecenyl)glycine (CAS Reg. No. 110– For use as a corrosion inhibitor at levels not to exceed 0.5 per- 25–8). cent by weight of the lubricant. N-phenylbenzenamine, reaction products with 2,4,4- For use only as an antioxidant at levels not to exceed 0.5 per- trimethylpentene (CAS Reg. No. 68411–46–1). cent by weight of the lubricant. Petrolatum ...... Complying with § 178.3700. Addition to food not to exceed 10 parts per million. Phenyl-a-and/or phenyl-b-naphthylamine ...... For use only, singly or in combination, as antioxidant in mineral oil lubricants at a level not to exceed a total of 1 percent by weight of the mineral oil. Phosphoric acid, mono- and dihexyl esters, compounds with For use only as an adjuvant at levels not to exceed 0.5 per- tetramethylnonylamines and C11-14 alkylamines. cent by weight of the lubricant. Phosphoric acid, mono- and diisooctyl esters, reacted with tert- For use only as a corrosion inhibitor or rust preventative alkyl and (C12-C14) primary amines (CAS Reg. No. 68187– inlubricants at a level not to exceed 0.5 percent by weight of 67–7). the lubricant.

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Substances Limitations

Phosphorothioic acid, O, O, O-triphenyl ester, tert-butyl deriva- For use only as an extreme pressure-antiwear adjuvant at a tives (CAS Reg. No. 192268–65–8). level not to exceed 0.5 percent by weight of the lubricant. Polyurea, having a nitrogen content of 9–14 percent based on For use only as an adjuvant in mineral oil lubricants at a level the dry polyurea weight, produced by reacting tolylene not to exceed 10 percent by weight of the mineral oil. diisocyanate with tall oil fatty acid (C16 and C18) amine and ethylene diamine in a 2:2:1 molar ratio. Polybutene (minimum average molecular weight 80,000) ...... Addition to food not to exceed 10 parts per million. Polybutene, hydrogenated; complying with the identity pre- Do. scribed under § 178.3740. Polyethylene ...... Do. Polyisobutylene (average molecular weight 35,000–140,000 For use only as a thickening agent in mineral oil lubricants. (Flory)). Sodium nitrite ...... For use only as a rust preventive in mineral oil lubricants at a level not to exceed 3 percent by weight of the mineral oil. Tetrakis[methylene(3,5-di-tert-butyl-4-hydroxyhydro- For use only as an antioxidant in lubricants at a level not to ex- cinnamate)]methane (CAS Reg. No. 6683–19–8). ceed 0.5 percent by weight of the lubricant. Thiodiethylenebis (3,5-di-tert-butyl-4-hydroxyhydrocinnamate) For use as an antioxidant at levels not to exceed 0.5 percent (CAS Reg. No. 41484-35-9). by weight of the lubricant. Tri[2(or 4)-C9-10-branched alkylphenyl]phosphorothioate (CAS For use only as an extreme pressure-antiwear adjuvant at lev- Reg. No. 126019–82–7). els not to exceed 0.5 percent by weight of the lubricant. Triphenyl phosphorothionate (CAS Reg. No. 597–82–0) ...... For use as an adjuvant in lubricants herein listed at a level not to exceed 0.5 percent by weight of the lubricant. Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. NO. 31570– For use only as a stabilizer at levels not to exceed 0.5 percent 04–4). by weight of the lubricant. Thiodiethylenebis(3,5-di-tert-butyl-4-hydroxy-hydro- cinnamate) For use as an antioxidant at levels not to exceed 0.5 percent (CAS Reg. No. 41484–35–9). by weight of the lubricant. Zinc sulfide ...... For use at levels not to exceed 10 percent by weight of the lubricant.

(b) The lubricants are used on food- starch, including industrial starch- processing equipment as a protective modified complying with § 178.3520, in- antirust film, as a release agent on gas- tended for use as a component of arti- kets or seals of tank closures, and as a cles that contact food. lubricant for machine parts and equipment in locations in which there is ex- § 178.3610 a-Methylstyrene- posure of the lubricated part to food. vinyltoluene resins, hydrogenated. The amount used is the minimum re- Hydrogenated a-methylstyrene- quired to accomplish the desired tech- vinyltoluene copolymer resins having a nical effect on the equipment, and the molar ratio of 1 -methylstyrene to 3 addition to food of any constituent a vinyltoluene may be safely used as identified in this section does not exceed the limitations prescribed. components of polyolefin film intended (c) Any substance employed in the for use in contact with food, subject to production of the lubricants described the following provisions: in this section that is the subject of a (a) Hydrogenated a-methylstyrene- regulation in parts 174, 175, 176, 177, 178 vinyltoluene copolymer resins have a and § 179.45 of this chapter conforms drop-softening point of 125° to 165 °C with any specification in such regula- and a maximum absorptivity of 0.17 tion. liter per gram centimeter at 266 nanometers, as determined by methods [42 FR 14609, Mar. 15, 1977] titled ‘‘Determination of Softening EDITORIAL NOTE: For FEDERAL REGISTER ci- Point (Drop Method)’’ and ‘‘Deter- tations affecting § 178.3570, see the List of mination of Unsaturation of Resin CFR Sections Affected, which appears in the Finding Aids section of the printed volume 1977,’’ which are incorporated by ref- and on GPO Access. erence. Copies are available from the Center for Food Safety and Applied Nu- § 178.3600 Methyl glucoside-coconut oil trition (HFS–200), Food and Drug Ad- ester. ministration, 5100 Paint Branch Pkwy., Methyl glucoside-coconut oil ester College Park, MD 20740, or available for identified in § 172.816(a) of this chapter inspection at the Office of the Federal may be safely used as a processing aid Register, 800 North Capitol Street, (filter aid) in the manufacture of NW., suite 700, Washington, DC 20408.

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(b) The polyolefin film is produced Maximum from olefin polymers complying with absorb- µ ance per § 177.1520 of this chapter, and the aver- Wavelength (m ) centimeter age thickness of the film in the form in optical pathlength which it contacts food does not exceed 0.002 inch. 300 to 329 ...... 2.3 330 to 350 ...... 0.8 [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, 1989] Technical white mineral oil containing antioxidants shall meet the specified § 178.3620 Mineral oil. ultraviolet absorbance limits after cor- Mineral oil may be safely used as a rection for any absorbance due to the component of nonfood articles intended antioxidants. The ultraviolet absorb- for use in contact with food, subject to ance shall be determined by the proce- the provisions of this section: dure described for application to min- (a) White mineral oil meeting the eral oil under ‘‘Specification’’ on page specifications prescribed in § 172.878 of 66 of the ‘‘Journal of the Association of this chapter may be used as a compo- Official Agricultural Chemists,’’ Vol- nent of nonfood articles provided such ume 45 (February 1962) (which is incor- use complies with any applicable limi- porated by reference; copies are avail- tations in parts 170 through 189 of this able from the Center for Food Safety chapter. The use of white mineral oil in and Applied Nutrition (HFS–200), Food or on food itself, including the use of and Drug Administration, 5100 Paint white mineral oil as a protective coat- Branch Pkwy., College Park, MD 20740, ing or release agent for food, is subject or available for inspection at the Office to the provisions of § 172.878 of this of the Federal Register, 800 North Cap- chapter. itol Street, NW., suite 700, Washington, (b) Technical white mineral oil iden- DC 20408), disregarding the last two tified in paragraph (b)(1) of this section sentences of that procedure and sub- may be used as provided in paragraph stituting therefor the following: Deter- (b)(2) of this section. mine the absorbance of the mineral oil (1) Technical white mineral oil con- extract in a 10-millimeter cell in the sists of specially refined distillates of range from 260–350 mµ, inclusive, com- virgin petroleum or of specially refined pared to the solvent control. If the ab- distillates that are produced syn- sorbance so measured exceeds 2.0 at thetically from petroleum gases. Tech- any point in range 280–350 mµ, inclu- nical white mineral oil meets the fol- sive, dilute the extract and the solvent lowing specifications: control, respectively, to twice their (i) Saybolt color 20 minimum as de- volume with dimethyl sulfoxide and re- termined by ASTM method D156–82, measure the absorbance. Multiply the ‘‘Standard Test Method for Saybolt remeasured absorbance values by 2 to Color of Petroleum Products (Saybolt determine the absorbance of the min- Chromometer Method),’’ which is in- eral oil extract per centimeter optical corporated by reference. Copies may be pathlength. obtained from the American Society (2) Technical white mineral oil may for Testing Materials, 1916 Race St., be used wherever mineral oil is per- Philadelphia, PA 19103, or may be ex- mitted for use as a component of amined at the Office of the Federal nonfood articles complying with Register, 800 North Capitol Street, §§ 175.105, 176.200, 176.210, 177.2260, NW., suite 700, Washington, DC 20408. 177.2600, and 177.2800 of this chapter and (ii) Ultraviolet absorbance limits as §§ 178.3570 and 178.3910. follows: (3) Technical white mineral oil may contain any antioxidant permitted in Maximum absorb- food by regulations issued in accord- µ ance per ance with section 409 of the Act, in an Wavelength (m ) centimeter optical amount not greater than that required pathlength to produce its intended effect. 280 to 289 ...... 4.0 (c) Mineral oil identified in para- 290 to 299 ...... 3.3 graph (c)(1) of this section may be used

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as provided in paragraph (c)(2) of this entire procedure is to be carried out under section. subdued light. (1) The mineral oil consists of virgin APPARATUS petroleum distillates refined to meet the following specifications: Separatory funnels. 250-milliliter, 500-milli- ° liter, 1,000-milliliter, and preferably 2,000- (i) Initial boiling point of 450 F min- milliliter capacity, equipped with tetra- imum. fluoroethylene polymer stopcocks. (ii) Color 5.5 maximum as determined Reservoir. 500-milliliter capacity, equipped by ASTM method D1500–82, ‘‘Standard with a 24/40 standard taper male fitting at Test Method for ASTM Color of Petro- the bottom and a suitable ball-joint at the leum Products (ASTM Color Scale),’’ top for connecting to the nitrogen supply. which is incorporated by reference. The The male fitting should be equipped with glass hooks. availability of this incorporation by Chromatographic tube. 180 millimeters in reference is given in paragraph (b)(1)(i) length, inside diameter to be 15.7 millimeters of this section. ±0.1 millimeter, equipped with a coarse, frit- (iii) Ultraviolet absorbance limits as ted-glass disc, a tetrafluoroethylene polymer follows as determined by the analytical stopcock, and a female 24/40 standard tapered method described in paragraph (c)(3) of fitting at the opposite end. (Overall length of this section: the column with the female joint is 235 millimeters.) The female fitting should be Maximum equipped with glass hooks. absorb- Disc. Tetrafluoroethylene polymer 2-inch µ ance per diameter disk approximately 3⁄16-inch thick Wavelength (m ) centimeter optical with a hole bored in the center to closely fit pathlength the stem of the chromatographic tube. Suction flask. 250-milliliter or 500-milliliter 280 to 289 ...... 0.7 filter flask. 290 to 299 ...... 0.6 Condenser. 24/40 joints, fitted with a drying 300 to 359 ...... 0.4 tube, length optional. 360 to 400 ...... 09 Evaporation flask (optional). 250-milliliter or 500-milliliter capacity all-glass flask (2) The mineral oil may be used wher- equipped with standard taper stopper having ever mineral oil is permitted for use as inlet and outlet tubes to permit passage of a component of nonfood articles com- nitrogen across the surface of contained liq- plying with §§ 175.105 and 176.210 of this uid to be evaporated. chapter and § 178.3910 (for use only in Spectrophotometric cells. Fused quartz cells, rolling of metallic foil and sheet optical path length in the range of 5,000 cen- ± stock), §§ 176.200, 177.2260, 177.2600, and timeter 0.005 centimeter; also for checking spectrophotometer performance only, optical 177.2800 of this chapter. path length in the range 1,000 centimeter (3) The analytical method for deter- ±0.005 centimeter. With distilled water in the mining ultraviolet absorbance limit is cells, determine any absorbance differences. as follows: Spectrophotometer. Spectral range 250 millimicrons—400 millimicrons with spectral slit GENERAL INSTRUCTIONS width of 2 millimicrons or less; under instru- Because of the sensitivity of the test, the ment operating conditions for these absorb- possibility of errors arising from contamina- ance measurements, the spectrophotometer tion is great. It is of the greatest importance shall also meet the following performance that all glassware be scrupulously cleaned to requirements: ± remove all organic matter such as oil, Absorbance repeatability, 0.01 at 0.4 ab- grease, detergent residues, etc. Examine all sorbance. 1 ± glassware, including stoppers and stopcocks, Absorbance accuracy 0.05 at 0.4 absorb- under ultraviolet light to detect any residual ance. fluorescent contamination. As a pre- cautionary measure it is recommended prac- 1 As determined by procedure using potas- tice to rinse all glassware with purified iso- sium chromate for reference standard and octane immediately before use. No grease is described in National Bureau of Standards to be used on stopcocks or joints. Great care Circular 484, Spectrophotometry, U.S. De- to avoid contamination of oil samples in partment of Commerce (1949). The accuracy handling and to assure absence of any extra- is to be determined by comparison with the neous material arising from inadequate standard values at 290, 345, and 400 milli- packaging is essential. Because some of the microns. Circular 484 is incorporated by ref- polynuclear hydrocarbons sought in this test erence. Copies are available from the Center are very susceptible to photo-oxidation, the Continued

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Wavelength accuracy, ±1.0 millimicron. Eluting mixtures: Nitrogen cylinder. Water-pumped or equiva- 1. 10 percent benzene in isooctane. Pipet 50 lent purity nitrogen in cylinder equipped milliliters of benzene into a 250-milliliter with regulator and valve to control flow at 5 glass-stoppered volumetric flask and adjust p.s.i.g. to volume with isooctane, with mixing. 2. 20 percent benzene in isooctane. Pipet 50 REAGENTS AND MATERIALS milliliters of benzene into a 250-milliliter Organic solvents. All solvents used through- glass-stoppered volumetric flask and adjust out the procedure shall meet the specifica- to volume with isooctane, with mixing. tions and tests described in this specifica- 3. Acetone-benzene-water mixture. Add 20 tion. The isooctane, benzene, acetone, and milliliters of water to 380 milliliters of ace- methyl alcohol designated in the list fol- tone and 200 milliliters of benzene, and mix. lowing this paragraph shall pass the fol- n-Hexadecane, 99-percent olefin-free. Dilute lowing test: 1.0 milliliter of n-hexadecane to 25 milliliters To the specified quantity of solvent in a with isooctane and determine the absorbance 250-milliliter Erlenmeyer flask, add 1 milli- in a 5-centimeter cell compared to isooctane liter of purified n-hexadecane and evaporate as reference point between 280 mµ–400 mµ. on the steam bath under a stream of nitro- The absorbance per centimeter path length gen (a loose aluminum foil jacket around the shall not exceed 0.00 in this range. Purify, if flask will speed evaporation). Discontinue necessary, by percolation through activated evaporation when not over 1 milliliter of res- silica gel or by distillation. idue remains. (To the residue from benzene Methyl alcohol, A.C.S. reagent grade. Use add a 10-milliliter portion of purified iso- 10.0 milliliters of methyl alcohol. Purify, if octane, reevaporate, and repeat once to in- necessary, by distillation. sure complete removal of benzene.) Dimethyl sulfoxide. Spectrophotometric Alternatively, the evaporation time can be grade (Crown Zellerbach Corporation, reduced by using the optional evaporation Camas, Washington, or equivalent). Absorb- flask. In this case the solvent and n-hexa- ance (1-centimeter cell, distilled water ref- decane are placed in the flask on the steam erence, sample completely saturated with ni- bath, the tube assembly is inserted, and a trogen). stream of nitrogen is fed through the inlet tube while the outlet tube is connected to a Absorb- solvent trap and vacuum line in such a way Wavelength ance (max- as to prevent any flow-back of condensate imum) into the flask. 261.5 ...... 1.00 Dissolve the 1 milliliter of hexadecane res- 270 ...... 20 idue in isooctane and make to 25 milliliters 275 ...... 09 volume. Determine the absorbance in the 5- 280 ...... 06 centimeter path length cells compared to 300 ...... 015 isooctane as reference. The absorbance of the solution of the solvent residue (except for There shall be no irregularities in the ab- methyl alcohol) shall not exceed 0.01 per cen- sorbance curve within these wavelengths. timeter path length between 280 and 400 mµ. Phosphoric acid. 85 percent A.C.S. reagent For methyl alcohol this absorbance value grade. shall be 0.00. Sodium borohydride. 98 percent. Isooctane (2,2,4-trimethylpentane). Use 180 Magnesium oxide (Sea Sorb 43, Food Machin- milliliters for the test described in the pre- ery Company, Westvaco Division, distributed by ceding paragraph. Purify, if necessary, by chemical supply firms, or equivalent). Place 100 passage through a column of activated silica grams of the magnesium oxide in a large gel (Grade 12, Davison Chemical Company, beaker, add 700 milliliters of distilled water Baltimore, Maryland, or equivalent) about 90 to make a thin slurry, and heat on a steam centimeters in length and 5 centimeters to 8 bath for 30 minutes with intermittent stir- centimeters in diameter. ring. Stir well initially to insure that all the Benzene, A.C.S. reagent grade. Use 150 milli- adsorbent is completely wetted. Using a liters for the test. Purify, if necessary, by Buchner funnel and a filter paper (Schleicher distillation or otherwise. & Schuell No. 597, or equivalent) of suitable Acetone, A.C.S. reagent grade. Use 200 milli- diameter, filter with suction. Continue suc- liters for the test. Purify, if necessary, by tion until water no longer drips from the distillation. funnel. Transfer the adsorbent to a glass trough lined with aluminum foil (free from for Food Safety and Applied Nutrition (HFS– rolling oil). Break up the magnesia with a 200), Food and Drug Administration, 5100 clean spatula and spread out the adsorbent Paint Branch Pkwy., College Park, MD 20740, on the aluminum foil in a layer about 1 cen- or available for inspection at the Office of timeter to 2 centimeters thick. Dry for 24 the Federal Register, 800 North Capitol hours at 160 °C ±1 °C. Pulverize the magnesia Street, NW., suite 700, Washington, DC 20408. with mortar and pestle. Sieve the pulverized

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adsorbent between 60–180 mesh. Use the mag- tions of preequilibrated isooctane to give a nesia retained on the 180-mesh sieve. total volume of the oil and solvent of 75 mil- Celite 545. Johns Mansville Company, diato- liliters. Shake the funnel vigorously for 2 maceous earth, or equivalent. minutes. Set up three 250-milliliter sepa- Magnesium oxide-Celite 545 mixture (2+1) by ratory funnels with each containing 30 milli- weight. Place the magnesium oxide (60–180 liters of pre-equilibrated isooctane. After mesh) and the Celite 545 in 2 to 1 propor- separation of liquid phases, carefully draw tions, respectively, by weight in a glass- off lower layer into the first 250-milliliter stoppered flask large enough for adequate separatory funnel and wash in tandem with mixing. Shake vigorously for 10 minutes. the 30-milliliter portions of isooctane con- Transfer the mixture to a glass trough lined tained in the 250-milliliter separatory fun- with aluminum foil (free from rolling oil) nels. Shaking time for each wash is 1 and spread it out on a layer about 1 centi- minute. Repeat the extraction operation meter to 2 centimeters thick. Reheat the with two additional portions of the sulf- mixture at 160 °C ±1 °C for 2 hours, and store oxide-acid mixture and wash each extractive in a tightly closed flask. in tandem through the same three portions Sodium sulfate, anhydrous, A.C.S. reagent of isooctane. grade, preferably in granular form. For each Collect the successive extractives (300 mil- bottle of sodium sulfate reagent used, estab- liliters total) in a separatory funnel (pref- lish as follows the necessary sodium sulfate erably 2-liter) containing 480 milliliters of prewash to provide such filters required in distilled water; mix, and allow to cool for a the method: Place approximately 35 grams of few minutes after the last extractive has anhydrous sodium sulfate in a 30-milliliter been added. Add 80 milliliters of isooctane to course, fritted-glass funnel or in a 65-milli- the solution and extract by shaking the fun- meter filter funnel with glass wool plug; nel vigorously for 2 minutes. Draw off the wash with successive 15-milliliter portions of lower aqueous layer into a second separatory the indicated solvent until a 15-milliliter funnel (preferably 2-liter) and repeat the ex- portion of the wash shows 0.00 absorbance traction with 80 milliliters of isooctane. per centimeter path length between 280 mµ Draw off and discard the aqueous layer. and 400 mµ when tested as prescribed under Wash each of the 80-milliliter extractives ‘‘Organic solvents.’’ Usually three portions three times with 100-milliliter portions of of wash solvent are sufficient. distilled water. Shaking time for each wash Before proceeding with analysis of a sam- is 1 minute. Discard the aqueous layers. Fil- ple, determine the absorbance in a 5-centi- ter the first extractive through anhydrous meter path cell between 250 millimicrons and sodium sulfate prewashed with isooctane (see 400 millimicrons for the reagent blank by Sodium sulfate under ‘‘Reagents and Mate- carrying out the procedure, without an oil rials’’ for preparation of filter) into a 250- sample, recording the spectra after the ex- milliliter Erlenmeyer flask (or optionally traction stage and after the complete proce- into the evaporation flask). Wash the first dure as prescribed. The absorbance per centi- separatory funnel with the second 80-millimeter pathlength following the extraction liter isooctane extractive and pass through stage should not exceed 0.02 in the wave- the sodium sulfate. Then wash the second length range from 280 mµ to 400 mµ; the ab- and first separatory funnels successively sorbance per centimeter pathlength fol- with a 20-milliliter portion of isooctane and lowing the complete procedure should not pass the solvent through the sodium sulfate exceed 0.02 in the wavelength range from 280 into the flask. Add 1 milliliter of n-hexa- mµ to 400 mµ. If in either spectrum the char- decane and evaporate the isooctane on the acteristic benzene peaks in the 250 mµ–260 steam bath under nitrogen. Discontinue mµ region are present, remove the benzene evaporation when not over 1 milliliter of res- by the procedure under ‘‘Organic solvents’’ idue remains. To the residue, add a 10-milli- and record absorbance again. liter portion of isooctane, reevaporate to 1 Place 300 milliliters of dimethyl sulfoxide milliliter of hexadecane, and repeat this opin a 1-liter separatory funnel and add 75 mil- eration once. liliters of phosphoric acid. Mix the contents Quantitatively transfer the residue with of the funnel and allow to stand for 10 min- isooctane to a 200-milliliter volumetric utes. (The reaction between the sulfoxide flask, make to volume, and mix. Determine and the acid is exothermic. Release pressure the absorbance of the solution in the 1-centi- after mixing, then keep funnel stoppered.) meter pathlength cells compared to iso- Add 150 milliliters of isooctane and shake to octane as reference between 280 mµ–400 mµ pre-equilibrate the solvents. Draw off the in- (take care to lose none of the solution in fill- dividual layers and store in glass-stoppered ing the sample cell). Correct the absorbance flasks. values for any absorbance derived from re- Weigh a 20-gram sample of the oil and agents as determined by carrying out the transfer to a 500-milliliter separatory funnel procedure without an oil sample. If the cor- containing 100 milliliters of pre-equilibrated rected absorbance does not exceed the limits sulfoxide-phosphoric acid mixture. Complete prescribed in this paragraph, the oil meets the transfer of the sample with small por- the ultraviolet absorbance specifications. If

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the corrected absorbance per centimeter sorbent level. Rapidly complete the transfer pathlength exceeds the limits prescribed in similarly with two 5–milliliter portions of this paragraph, proceed as follows: Quan- isooctane, swirling the flask repeatedly each titatively transfer the isooctane solution to time to assure adequate washing of the res- a 125-milliliter flask equipped with 24/40 idue. Just before the final 5–milliliter wash joint, and evaporate the isooctane on the reaches the top of the adsorbent, add 100 mil- steam bath under a stream of nitrogen to a liliters of isooctane to the reservoir and con- volume of 1 milliliter of hexadecane. Add 10 tinue the percolation at the 2–3 milliliters milliliters of methyl alcohol and approxi- per minute rate. Just before the last of the mately 0.3 gram of sodium borohydride. isooctane reaches the adsorbent level, add (Minimize exposure of the borohydride to the 100 milliliters of 10 percent benzene in iso- atmosphere. A measuring dipper may be octane to the reservoir and continue the per- used.) Immediately fit a water-cooled con- colation at the aforementioned rate. Just be- denser equipped with a 24/40 joint and with a fore the solvent mixture reaches adsorbent drying tube into the flask, mix until the level, add 25 milliliters of 20 percent benzene borohydride is dissolved, and allow to stand for 30 minutes at room temperature, with in isooctane to the reservoir and continue intermittent swirling. At the end of this pe- the percolation at 2–3 milliliters per minute riod, disconnect the flask and evaporate the until all this solvent mixture has been re- methyl alcohol on the steam bath under ni- moved from the column. Discard all the trogen until the sodium borohydride begins elution solvents collected up to this point. to come out of the solution. Then add 10 mil- Add 300 milliliters of the acetone-benzene- liliters of isooctane and evaporate to a vol- water mixture to the reservoir and percolate ume of about 2–3 milliliters. Again, add 10 through the column to eluate the milliliters of isooctane and concentrate to a polynuclear compounds. Collect the eluate in volume of approximately 5 milliliters. Swirl a clean 1-liter separatory funnel. Allow the the flask repeatedly to assure adequate column to drain until most of the solvent washing of the sodium borohydride residues. mixture is removed. Wash the eluate three Fit the tetrafluoroethylene polymer disc times with 300-milliliter portions of distilled on the upper part of the stem of the water, shaking well for each wash. (The addi- chromatographic tube, then place the tube tion of small amounts of sodium chloride fa- with the disc on the suction flask and apply cilitates separation.) Discard the aqueous the vacuum (approximately 135 millimeters layer after each wash. After the final separa- Hg pressure). Weigh out 14 grams of the 2:1 tion, filter the residual benzene through an- magnesium oxide-Celite 545 mixture and hydrous sodium sulfate pre-washed with ben- pour the adsorbent mixture into the zene (see Sodium sulfate under ‘‘Reagents chromatographic tube in approximately 3- and Materials’’ for preparation of filter) into centimeter layers. After the addition of each a 250-milliliter Erlenmeyer flask (or option- layer, level off the top of the adsorbent with ally into the evaporation flask). Wash the a flat glass rod or metal plunger by pressing separatory funnel with two additional 20- down firmly until the adsorbent is well milliliter portions of benzene which are also packed. Loosen the topmost few millimeters filtered through the sodium sulfate. Add 1 of each adsorbent layer with the end of a metal rod before the addition of the next milliliter of n-hexadecane and completely re- layer. Continue packing in this manner until move the benzene by evaporation under ni- all the 14 grams of the adsorbent is added to trogen, using the special procedure to elimi- the tube. Level off the top of the adsorbent nate benzene as previously described under by pressing down firmly with a flat glass rod ‘‘Organic solvents.’’ Quantitatively transfer or metal plunger to make the depth of the the residue with isooctane to a 200-milliliter adsorbent bed approximately 12.5 centi- volumetric flask and adjust to volume. De- meters in depth. Turn off the vacuum and re- termine the absorbance of the solution in the move the suction flask. Fit the 500–milliliter 1-centimeter pathlength cells compared to reservoir onto the top of the isooctane as reference between 250 mµ–400 chromatographic column and prewet the col- mµ. Correct for any absorbance derived from umn by passing 100 milliliters of isooctane the reagents as determined by carrying out through the column. Adjust the nitrogen the procedure without an oil sample. If ei- pressure so that the rate of descent of the ther spectrum shows the characteristic ben- isooctane coming off the column is between zene peaks in the 250 mµ–260 mµ region, evap- 2–3 milliliters per minute. Discontinue pres- orate the solution to remove benzene by the sure just before the last of the isooctane procedure under ‘‘Organic solvents.’’ Dis- reaches the level of the adsorbent. (Caution: solve the residue, transfer quantitatively, Do not allow the liquid level to recede below and adjust to volume in isooctane in a 200- the adsorbent level at any time.) Remove the milliliter volumetric flask. Record the ab- reservoir and decant the 5–milliliter iso- sorbance again. If the corrected absorbance octane concentrate solution onto the column does not exceed the limits proposed in this and with slight pressure again allow the liq- paragraph, the oil meets the proposed ultra- uid level to recede to barely above the ad- violet absorbance specifications.

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(d) Mineral oil identified in para- fluoroethylene polymer stopcock. The oppo- graph (d)(1) of this section may be used site end is flanged and joined to a female 24/ as provided in paragraph (d)(2) of this 40 standard taper fitting. This provides for section. accommodating the 500-milliliter reservoir described in item I.E below. (1) The mineral oil consists of virgin D. A chromatographic column made from petroleum distillates refined to meet nominal 1.7 centimeters outside diameter × the following specifications: 115 centimeters glass tubing tapered at one (i) Distillation endpoint at 760 milli- end and joined to a 2-millimeter-bore tetra- meters pressure not to exceed 371 °C, fluoroethylene polymer stopcock. The oppo- with a maximum residue not to exceed site end is flanged and joined to a 2.5 centi- 2 percent, as determined by ASTM meters outside diameter × 9.0 centimeters method D86–82, ‘‘Standard Method for glass tube having a female 24/40 standard Distillation of Petroleum Products,’’ taper fitting. This provides for accommodating the 500-milliliter reservoir described which is incorporated by reference. The in item I. E below. availability of this incorporation by E. A 500-milliliter reservoir having a 24/40 reference is given in paragraph (b)(1)(i) standard taper male fitting at bottom and a of this section. suitable ball joint at the top for connecting (ii) Ultraviolet absorbance limits as to the nitrogen supply. The female fitting of follows as determined by the method the chromatographic columns described in described in paragraph (d)(3) of this items I. C and D above and the male fitting section. of the reservoir described in this item E should both be equipped with glass hooks.

Maximum (NOTE: Rubber stoppers are not to be used. absorb- µ ance per Stopcock grease is not to be used on ground- Wavelength (m ) centimeter glass joints in this method.) optical pathlength F. A spectrophotometer equipped to auto- matically record absorbance of liquid sam- 280 to 299 ...... 2.3 300 to 319 ...... 1.2 ples in 1-centimeter pathlength cells in the 320 to 359 ...... 8 spectral region of 280–400 mµ with a spectral 360 to 400 ...... 3 slit width of 2 mµ or less. At an absorbance level of about 0.4, absorbance measurements (iii) Pyrene content not to exceed a shall be repeatable within ±0.01 and accurate maximum of 25 parts per million as de- within ±0.05. Wavelength measurements shall ± µ termined by the method described in be repeatable with 0.2 m and accurate within ±1.0 mµ. Instrument operating condi- paragraph (d)(3) of this section. tions are selected to realize this performance (2) The mineral oil may be used only under dynamic (automatic) recording oper- in the processing of jute fiber employed ations. Accuracy of absorbance measure- in the production of textile bags in- ments are determined at 290, 345, and 400 mµ, tended for use in contact with the fol- using potassium chromate as the reference lowing types of food: Dry grains and standard. (National Bureau of Standards Cir- dry seeds (for example, beans, peas, cular 484, Spectrophotometry, U.S. Depart- rice, and lentils); whole root crop vege- ment of Commerce, 1949.) tables of the types identified in 40 CFR G. Two fused quartz cells having pathlengths of 1.00±0.005 centimeter or bet- 180.34(f); unshelled and shelled nuts (inter. cluding peanuts); and dry animal feed. II. Purity of reagents and materials. Reagent- The finished processed jute fiber shall grade chemicals shall be used in all tests. It contain no more than 6 percent by is further specified that each chemical shall weight of residual mineral oil. be tested for purity in accordance with the (3) The analytical method for deter- instruction given under ‘‘Reagents and Mate- mining ultraviolet absorbance limits rials’’ in III below. In addition, a blank run and pyrene content is as follows: by the procedure shall be made on each purified lot of reagents and materials. Unless I. Apparatus. A. Assorted beakers, sepa- otherwise indicated, references to water ratory funnels fitted with tetrafluoro- shall be understood to mean distilled water. ethylene polymer stopcocks, and graduated III. Reagents and materials— A. Organic sol- cylinders. vents. All solvents used throughout the pro- B. Volumetric flasks, 200-milliliter. cedure shall meet the specifications and C. A chromatographic column made from tests described in this section III. The iso- nominal 1.3 centimeters outside diameter × octane, benzene, cyclohexane, nitromethane, 75 centimeters glass tubing tapered at one and n-hexadecane designated shall pass the end and joined to a 2-millimeter-bore tetra- following test: To the specified quantity of

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solvent in a 150-milliliter beaker, add 1 milli- store in a vacuum desiccator. Reheating liter of purified n-hexadecane and evaporate about once a week is necessary if the silica on the steam bath under a stream of nitro- gel is repeatedly removed from the desic- gen. Discontinue evaporation when not over cator. 1 milliliter of residue remains (to the residue 5. Aluminum oxide (Aluminum Co. of America, from benzene and nitromethane add a 10-mil- Grade F-20, or equivalent grade). 80–200 mesh, liliter portion of purified isooctane, re-evap- purified and activated by the following pro- orate, and repeat once to insure complete re- cedure: Place about 1 kilogram of aluminum moval of solvent). Dissolve the 1 milliliter of oxide in a large column and wash with con- n-hexadecane residue in isooctane and make taminant-free benzene until a 200-milliliter to 10-milliliter volume. Determine the ab- sample of the benzene coming off the column sorbance in 1.0-centimeter pathlength cells will pass the ultraviolet absorption test for compared to water as reference. The absorb- benzene. This test is performed as stipulated ance of the solution of solvent residue shall under ‘‘Organic solvents’’ in A under III not exceed 0.05 between 280 and 400 mµ. above. (Caution! Remove Benzene From Ad- 1. Isooctane (2,2,4-trimethylpentane). Use 240 sorbent Under Vacuum To Minimize Explo- milliliters for the above test. Purify, if nec- sion Hazard in Subsequent Heating!) When essary, by passage through a column of acti- the aluminum oxide has been sufficiently vated silica gel. cleaned and freed of solvent, activate it be- 2. Benzene. Use 200 milliliters for the above fore use by placing the 1-kilogram batch in a test. Purify, if necessary, by distillation or shallow container in a layer no greater than otherwise. 1 inch in depth. Heat in an oven at 130 °C for 3. Cyclohexane. Use 70 milliliters for the 16 hours. Upon removal from heat, store at above test. Purify, if necessary, by distilla- atmospheric pressure over 80 percent (by tion, silica gel percolation, or otherwise. weight) sulfuric acid in a desiccator for at 4. Nitromethane. Use 125 milliliters for the least 36 hours before use. This gives alu- above test. Purify, if necessary, by distilla- minum oxide with between 6 to 9.5 percent tion or otherwise. volatiles. This is determined by heating a 5. n-Hexadecane. Determine the absorbance weighed sample of the prepared aluminum on this solvent directly. Purify, if necessary, oxide at 2,000 °F for 2 hours and then quickly by silica gel percolation or otherwise. reweighing. To insure the proper adsorptive B. Other materials—1. Pyrene standard ref- properties of the aluminum oxide, perform erence. Pyrene, reagent grade, melting point the following test: range 150–152 °C. (Organic Chemical 3627, a. Weigh 50 grams ±1 gram of the activated Eastman Kodak Co., Rochester, N.Y., or aluminum oxide and pack into the equivalent). The standard reference absorb- chromatographic column (1.3 centimeters × ance is the absorbance at 334 millimicrons of 75 centimeters) described under ‘‘Apparatus’’ a standard reference solution of pyrene con- in C under I above. Use glass wool at the col- taining a concentration of 1.0 milligram per umn exit to prevent the aluminum oxide liter in purified isooctane measured against from passing through the column. isooctane of the same spectral purity in 1.0- b. Place a 250-milliliter graduated cylinder centimeter cells. (This absorbance will be ap- under the column to measure the amount of proximately 0.28.) eluate coming from the column. 2. Chrysene solution. Prepare a solution at a c. Prewet the aluminum oxide by passing concentration of 5.0 milligrams per liter by 40 milliliters of isooctane through the col- dissolving 5.0 milligrams of chrysene in puri- umn. Adjust the nitrogen pressure so that fied isooctane in a 1-liter volumetric flask. the rate of descent of the isooctane coming Adjust to volume with isooctane. off the column is between 1.5 to 2.5 milli- 3. Nitrogen gas. Water pumped or equivalent liters per minute. purity, cylinder with regulator, and valve d. Just prior to the last of the isooctane control flow at 5 p.s.i. reaching the top of the aluminum oxide bed, 4. Silica gel. 100–200 mesh (Davison Chem- add 10 milliliters of the isooctane solution ical, Baltimore, Md., Grade 923, or equiva- containing 5.0 milligrams of chrysene per lent), purified and activated by the following liter. procedure: Place about 1 kilogram of silica e. Continue percolation until the isooctane gel in a large column and wash with con- is just above the aluminum oxide. Then add taminant-free benzene until a 200-milliliter 200 milliliters of a mixture of benzene and sample of the benzene coming off the column isooctane (331⁄3 percent benzene and 662⁄3 per- will pass the ultraviolet absorption test for cent isooctane by volume) to the reservoir benzene. This test is performed as stipulated and continue percolation. under ‘‘Organic solvents’’ in A under III f. Continue percolation, collecting the above. When the silica gel has been suffi- eluates (40 milliliters of the prewet solution, ciently cleaned, activate the gel before use 10 milliliters of the sample solution, and 200 by placing the 1-kilogram batch in a shallow milliliters of the gradient solution) in the container in a layer no greater than 1 inch in 250-milliliter graduated cylinder until the depth and heating in an oven (Caution! Ex- level of the gradient solution is just above plosion Hazard) at 130 °C. for 16 hours, and the aluminum oxide. Add 200 milliliters of

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the eluting solution of benzene and isooctane voids. All percolations using aluminum oxide (90 percent benzene and 10 percent isooctane are performed under nitrogen pressure. The by volume) to the column and continue col- 500-milliliter reservoir described under ‘‘Ap- lecting until a total of 250 milliliters of solu- paratus’’ in E under I above is to be used to tion has been obtained. This may be dis- hold the elution solvents.) carded. Now begin to collect the final eluate. 5. Prewet the column by adding 40 milli- g. Place a 100-milliliter graduated cylinder liters of isooctane to the column. Adjust ni- under the column and continue the percola- trogen pressure so that rate of descent of the tion until a 100-milliliter eluate has been ob- isooctane coming off the column is 2.0 to 3.0 tained. milliliters per minute. Be careful to main- h. Measure the amount of chrysene in this tain the level of solvent in the reservoir to 100-milliliter fraction by ultraviolet anal- prevent air from entering the aluminum ysis. If the aluminum oxide is satisfactory, oxide bed. New or additional solvent is added more than 80 percent of the original amount just before the last portion of the previous of chrysene should be found in this fraction. solvent enters the bed. To minimize possible (NOTE: If the amount of chrysene recovered photo-oxidation effects, the following proce- is less than 80 percent, the original batch of dures (steps 6 through 18) shall be carried out aluminum oxide should be sieved between in subdued light. 100–160 mesh. Activation and testing of this 6. Before the last of the isooctane reaches sieved batch should indicate a satisfactory the top of the aluminum oxide bed, release aluminum oxide for use.) the nitrogen pressure and turn off the stop- IV. Sampling. Precautions must be taken to cock on the column. Transfer the n-hexa- insure that an uncontaminated sample of the decane residue from the 150-milliliter beaker mineral oil is obtained since ultraviolet ab- from procedure step 3 above onto the col- sorption is very sensitive to small amounts umn, using several washes of isooctane (total of extraneous material contaminating the volume of washes should be no greater than sample through careless handling. 10–15 milliliters). V. Procedure. A. Blank. Before proceeding 7. Open the stopcock and continue percola- with the analysis of a sample, determine the tion until the isooctane is about 1 centi- absorbance of the solvent residues by car- meter above the top of the aluminum oxide rying out the procedure without a sample. bed. Add 200 milliliters of isooctane to the B. Sample. 1. Weigh out 20.0 grams ±0.1 reservoir, and continue the percolation at gram of the mineral oil into a beaker and the specified rate. transfer to a 250-milliliter separatory funnel 8. Just before the isooctane surface reaches fitted with a tetrafluoroethylene polymer the top of the aluminum oxide bed, add 200 stopcock, using enough cyclohexane (25 mil- milliliters of a mixture of benzene and iso- liliters) to give a final total volume of 50 octane (331⁄3 percent benzene and 662⁄3 percent milliliters (mineral oil plus cyclohexane). isooctane by volume) to the reservoir, and 2. Add 25 milliliters of nitromethane satu- continue the percolation. rated with cyclohexane and shake by hand 9. Just before the surface of this mixture vigorously for 3 minutes. Recover the lower reaches the top of the aluminum oxide bed, nitromethane layer in a 150-milliliter beaker release the nitrogen pressure, turn off the containing 1 milliliter of n-hexadecane and stopcock, and discard all the elution solvents evaporate on the steam bath under nitrogen. collected up to this point. Repeat the extraction four more times, re- 10. Add to the reservoir 300 milliliters of a covering each extract in the 150-milliliter mixture of benzene and isooctane (90 percent beaker. Exercise care not to fill the beaker benzene and 10 percent isooctane by volume), to such a capacity that solvent losses may place a 25-milliliter graduated cylinder occur. Evaporate the combined under the column, continue the percolation nitromethane extracts to 1 milliliter of n- until 20 milliliters of eluate has been col- hexadecane residue containing the lected, and then discard the eluate. nitromethane-soluble mineral oil extrac- 11. At this point, place a clean 250-milli- tives. (NOTE: Complete removal of the liter Erlenmeyer flask under the column. nitromethane is essential. This can be as- Continue the percolation and collect all the sured by two successive additions of 5 milli- remaining eluate. liters of isooctane and reevaporation.) (NOTE: Allow the column to drain com- 3. Remove the beaker from the steam bath pletely. An increase in the nitrogen pressure and allow to cool. may be necessary as the last of the solvent 4. Weigh 50 grams ±1 gram of activated alu- comes off the column.) minum oxide and pack into the 12. Place 1 milliliter of n-hexadecane into a chromatographic column (1.3 centimeters × 150-milliliter beaker. Place this onto a steam 75 centimeters) described under ‘‘Apparatus’’ bath under a nitrogen stream and transfer in in C under I above. (NOTE: A small plug of small portions the eluate from step 11 above. glass wool is placed at the column exit to Wash out the Erlenmeyer flask with small prevent the aluminum oxide from passing amounts of benzene and transfer to the evap- through the column. After adding aluminum oration beaker. Evaporate until only 1 milli- oxide, tap the column lightly to remove air liter of hexadecane residue remains. (NOTE:

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Complete removal of the benzene is essen- 18. Transfer the residue with several wash- tial. This can be assured by two successive es of isooctane into a 200-milliliter volu- additions of 5 milliliters of isooctane and re- metric flask. Add isooctane to mark. evaporation.) 19. Record the spectrum of the sample solu- 13. Remove the beaker from the steam bath tion in a 1-centimeter cell compared to iso- and cool. octane from 270 to 400 mµ. After making nec- 14. Place a sample of 113.5 grams activated essary corrections in the spectrum for cell 100- 200-mesh silica gel in a 500-milliliter differences and for the blank absorbance, glass-stoppered Erlenmeyer flask. Add to the record the maximum absorbance in each of silica gel 46.2 grams (41 milliliters) of the wavelength intervals (mµ), 280–299, 300– nitromethane. Stopper and shake the flask 319, 320–359, 360–400. vigorously until no lumps of silica gel are a. If the spectrum then shows no discern- observed and then shake occasionally during ible peak corresponding to the absorbance a period of 1 hour. The resultant maximum of the pyrene reference standard µ nitromethane-treated silica gel is 29 weight- solution at 334 m , the maximum percent nitro-methane and 71 weight-percent absorbances in the respective wavelength in- silica gel. tervals recorded shall not exceed those pre- 15. Place a small plug of glass wool in the scribed in paragraph (d)(1)(ii) of this section. b. If such a peak is evident in the spectrum tapered end of the 1.7 centimeters outside di- of the sample solution, and the spectrum as ameter × 115 centimeters column, described a whole is not incompatible with that of a under ‘‘Apparatus’’ in D of I above, adjacent pyrene contaminant yielding such a peak of to the stopcock to prevent silica gel from the observed absorbance, calculate the con- passing through the stopcock. Pack the centration of pyrene that would yield this nitromethane-treated silica gel into the col- peak (334 m) by the base-line technique de- umn, tapping lightly. The resultant silica gel scribed in ASTM method E169–63 (Re- bed should be about 95 centimeters in depth. approved 1981), ‘‘Standard Recommended Place into a flask 170 milliliters of isooctane Practices for General Techniques of Ultra- saturated with nitromethane. violet Quantitative Analysis,’’ which is in- 16. Place a 100-milliliter graduated cyl- corporated by reference. The availability of inder under the column and transfer the res- this incorporation by reference is given in idue from the beaker in procedure step 13 paragraph (b)(1)(i) of this section. Correct above with several washes of the 170 milli- each of the maximum absorbances in the re- liters of isooctane, saturated with spective specified wavelength intervals by nitromethane, onto the top of the column. subtracting the absorbance due to pyrene, (Total volume of washes should be no greater determined as follows: than 10 to 15 milliliters.) Permit isooctane solution to enter the silica gel bed until the Cp × Sa liquid level is at the top bed level. Place the Absorbance due to pyrene = remaining amount of the 170 milliliters of Sp isooctane, saturated with nitromethane, in the reservoir above the bed for percolation where: through the silica gel. Apply nitrogen pres- Cp=Calculated concentration of pyrene in sure to the top of the column, adjusting the sample solution; pressure so that the isooctane is collected at Sp=Concentration of pyrene reference stand- the rate of 2.5 to 3.5 milliliters per minute, ard solution in same units of concentra- and percolate isooctane through the bed tion; until a quantity of 75.0 milliliters of eluate is Sa=Absorbance of pyrene reference standard collected. Discard the 75 milliliters of eluate. solution at wavelength of maximum ab- Turn off the stopcock and add 250 milliliters sorbance of sample solution in the respec- of benzene to the reservoir above the bed. tive specified wavelength intervals. Use a 400-milliliter beaker to collect the re- Also calculate the pyrene content of the maining eluate. oil sample in parts per million as follows: 17. Open the stopcock, renew the pressure, Pyrene content (/200 1000 )× C and percolate the remaining isooctane and = = 10C benzene through the column eluting the re- (p.p.m.) maining aromatics. Transfer the eluate in 20/ 1000 small portions from the 400 milliliter beaker where: to a 150-milliliter beaker containing 1 milli- C=Calculated concentration of pyrene in milliter of n-hexadecane and evaporate on the ligrams per liter of sample solution. steam bath under nitrogen. Rinse the 400- c. The pyrene content so determined shall milliliter beaker well with small portions of not exceed 25 p.p.m. The maximum isooctane to obtain a complete transfer. absorbances corrected for pyrene content as (NOTE: Complete removal of the described in this step 19 for each of the speci- nitromethane and benzene is essential. This fied wavelength intervals shall not exceed can be assured by successive additions of 5 the limits prescribed in paragraph (d)(1)(ii) milliliters of isooctane and reevaporation.) of this section.

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d. If the spectrum as a whole of the sample The additive is chiefly paraffinic, solution is in any respect clearly incompat- isoparaffinic, or naphthenic in nature. ible with the presence of pyrene as the (b) The additive meets the following source of the peak at 334 mµ, then the maximum absorbances in the respective wave- specifications: length intervals without correction for any (1) Odor is faint and not kerosenic. assumed pyrene content shall not exceed the (2) Initial boiling point is 300 °F min- limits prescribed in paragraph (d)(1)(ii) of imum. this section. (3) Final boiling point is 650 °F max- [42 FR 14609, Mar. 15, 1977, as amended at 47 imum. FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, (4) Ultraviolet absorbance limits de- 1984; 54 FR 24898, June 12, 1989] termined by method specified in § 178.3620(b)(1)(ii), as follows: § 178.3650 Odorless light petroleum hydrocarbons. Maximum absorb- Odorless light petroleum hydro- Wavelength (Mµ) ance per carbons may be safely used, as a com- centimeter optical ponent of nonfood articles intended for pathlength use in contact with food, in accordance with the following prescribed condi- 280 to 289 ...... 4.0 290 to 299 ...... 3.3 tions: 300 to 329 ...... 2.3 (a) The additive is a mixture of liquid 330 to 360 ...... 8 hydrocarbons derived from petroleum or synthesized from petroleum gases. (c) The additive is used as follows:

Use Limitations

As a plasticizer and absorber oil in the manufacture of In an amount not to exceed that required to produce intended polyolefin articles authorized for food contact use. effect, consistent with good manufacturing practice. As a lubricant of fibers of textiles authorized for food contact At a use level not to exceed 0.15 percent by weight of finished use. fibers. As a component of adhesives ...... Complying with § 175.105 of this chapter. As a defoamer in the manufacture of paper and paperboard .... Complying with § 176.210 of this chapter. As a defoamer in coatings ...... Complying with § 176.200 of this chapter.

§ 178.3690 Pentaerythritol adipate-ste- (b) Specifications. Pentaerythritol adi- arate. pate-stearate has the following speci- Pentaerythritol adipate-stearate fications: identified in paragraph (a) of this sec- (1) Melting point (dropping) of 55–58 tion may be safely used as a lubricant °C as determined by ASTM method in the fabrication of rigid and semi- D566–76 (Reapproved 1982), ‘‘Standard rigid polyvinyl chloride and/or vinyl Test Method for Dropping Point of Lu- chloride-propylene copolymers com- bricating Grease,’’ which is incor- plying with § 177.1980 of this chapter porated by reference. Copies may be used as articles or components of arti- obtained from the American Society cles that contact food, excluding food for Testing Materials, 1916 Race St., with alcohol content greater than 8 Philadelphia, PA 19103, or may be ex- percent under conditions of use of E, F, amined at the Office of the Federal and G described in table 2 in § 175.300(d) Register, 800 North Capitol Street, of this chapter, subject to the provi- NW., suite 700, Washington, DC 20408. sions of this section. (2) Acid value not to exceed 15 as de- (a) Identity. For the purpose of this termined by ASTM method D1386–78, section, pentaerythritol adipate-stea- ‘‘Standard Test Method for Saponifica- rate is an ester of pentaerythritol with tion Number (Empirical) of Synthetic adipic acid and stearic acid and its as- and Natural Waxes’’ (Revised 1978), sociated fatty acids (chiefly palmitic), which is incorporated by reference. with adipic acid comprising 14 percent Copies are available from American So- and stearic acid and its associated ciety for Testing and Materials acids (chiefly palmitic) comprising 71 percent of the organic moieties.

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(ASTM), 1916 Race Street, Philadel- Ultraviolet absorbance per centi- phia, PA 19103, or available for inspec- meter pathlength: tion at the Office of the Federal Reg- ister, 800 North Capitol Street, NW., Millimicrons Maximum suite 700, Washington, DC 20408. 280 to 289 ...... 0.25 (3) Saponification number of 270–280 290 to 299 ...... 20 as determined by ASTM method D1387– 300 to 359 ...... 14 78, ‘‘Standard Test Method for Acid 360 to 400 ...... 04 Number (Empirical) of Synthetic and (c) It is used or intended for use as a Natural Waxes’’ (Revised 1978), which is protective coating of the surfaces of incorporated by reference. Copies are metal or wood tanks used in fermenta- available from American Society for tion process, in an amount not in ex- Testing and Materials (ASTM), 1916 cess of that required to produce its in- Race Street, Philadelphia, PA 19103, or tended effect. available for inspection at the Office of (d) Petrolatum as defined by this sec- the Federal Register, 800 North Capitol tion may be used for the functions de- Street, NW., suite 700, Washington, DC scribed and within the limitations pre- 20408. (4) Iodine number not to exceed 2 as scribed by specific regulations in parts determined by Iodine Absorption Num- 175, 176, 177, and 178 of this chapter ber, Hanus Method, of the ‘‘Official which prescribe uses of petrolatum. Methods of Analysis of the Association For the purpose of cross-reference, of Official Analytical Chemists,’’ sec- such specific regulations include: tions 28.018–28.019, 13th Ed. (1980), which §§ 175.105, 175.125, 175.300, 176.170, 176.200, is incorporated by reference. Copies 176.210, 177.2600, 177.2800, and 178.3570 of may be obtained from the Association this chapter. of Official Analytical Chemists Inter- (e) Petrolatum may contain any anti- national, 481 North Frederick Ave., oxidant permitted in food by regula- suite 500, Gaithersburg, MD 20877–2504, tions issued pursuant to section 409 of or may be examined at the Office of the the act, in an amount not greater than Federal Register, 800 North Capitol that required to produce its intended Street, NW., suite 700, Washington, DC effect. 20408. [42 FR 14609, Mar. 15, 1977, as amended at 49 (c) The total amount of ester (cal- FR 10113, Mar. 19, 1984; 55 FR 12172, Apr. 2, culated as free pentaerythritol) shall 1990] not exceed 0.4 percent by weight of the polyvinyl chloride and/or the vinyl § 178.3710 Petroleum wax. chloride-propylene copolymers com- Petroleum wax may be safely used as plying with § 177.1980. a component of nonfood articles in contact with food, in accordance with the [45 FR 1018, Jan. 4, 1980, as amended at 47 FR 11848, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984; following conditions: 54 FR 24898, June 12, 1989; 57 FR 18082, Apr. (a) Petroleum wax is a mixture of 29, 1992] solid hydrocarbons, paraffinic in nature, derived from petroleum, and re- § 178.3700 Petrolatum. fined to meet the specifications pre- Petrolatum may be safety used as a scribed in this section. component of nonfood articles in con- (b) The petroleum wax meets the fol- tact with food, in accordance with the lowing ultraviolet absorbance limits following conditions: when subjected to the analytical proce- (a) Petrolatum complies with the dure described in § 172.886(b) of this specifications set forth in the United chapter. States Pharmacopeia XX (1980) for Ultraviolet absorbance per centi- white petrolatum or in the National meter pathlength: Formulary XV (1980) for yellow petrolatum. Millimicrons Maximum (b) Petrolatum meets the following 280 to 289 ...... 0.15 ultraviolet absorbance limits when 290 to 299 ...... 12 subjected to the analytical procedure 300 to 359 ...... 08 described in § 172.886(b) of this chapter: 360 to 400 ...... 02

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(c) Petroleum wax may contain any 27029–57–8), as described in § 172.886(c)(2) antioxidant permitted in food by regu- of this chapter, as a processing aid in lations issued in accordance with sec- the manufacture of petroleum wax. tion 409 of the act, in an amount not greater than that required to produce [42 FR 14609, Mar. 15, 1977, as amended at 51 its intended effect. FR 19545, May 30, 1986] (d) Petroleum wax may contain a total of not more than 1 weight percent § 178.3720 Petroleum wax, synthetic. of residues of the following polymers Synthetic petroleum wax may be when such residues result from use of safely used in applications and under the polymers as processing aids (filter the same conditions where naturally aids) in the production of the petro- derived petroleum wax is permitted in leum wax: Homopolymers and/or co- subchapter B of this chapter as a com- polymers derived from one or more of ponent of articles intended to contact the mixed n-alkyl (C12, C14, C16, and C18) food, provided that the synthetic petro- methacrylate esters where the C12 and leum wax meets the definition and C14 alkyl groups are derived from coco- specifications prescribed in § 172.888 of nut oil and the C16 and C18 groups are this chapter. derived from tallow. (e) Petroleum wax may contain 2-hy- § 178.3725 Pigment dispersants. droxy-4-n-octoxybenzophenone as a stabilizer at a level not to exceed 0.01 Subject to the provisions of this reg- weight percent of the petroleum wax. ulation, the substances listed in this (f) Petroleum wax may contain section may be safely used as pigment poly(alkylacrylate) (CAS Reg. No. dispersants in food-contact materials.

Substances Limitations

Dimethylolpropionic acid (CAS Reg. No. 4767–03–7) ...... For use only at levels not to exceed 0.45 percent by weight of the pigment. The pigmented articles may contact all foods under conditions of use A through H as described in Table 2 of § 176.170(c) of this chapter. Phosphorylated tall oil fatty acids (CAS Reg. No. 68604–99–9), For use only at levels not to exceed 1.0 percent by weight of prepared by the reaction of dimethyl hydrogen phosphite the pigment. The pigmented polymeric films may contact all with tall oil fatty acids. food under conditions of use D, E, F, and G described in table 2 of § 176.170(c) of this chapter. Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, compd. For use only at levels not to exceed 0.45 percent by weight of with 1,1′,1″-nitrilotris [2-propanol] (1:1) (CAS Reg. No. the pigment. The pigmented articles may contact all food 221281–21–6). under conditions of use A through H as described in Table 2 of § 176.170(c) of this chapter. Siloxanes and silicones; cetylmethyl, dimethyl, methyl 11- For use only at levels not to exceed 0.5 percent by weight of methoxy-11-oxoundecyl (CAS Reg. No. 155419–59–3). the pigment. The pigmented polymers may contact all foods under conditions of use C, D, E, F, and G described in Table 2 of § 176.170(c) of this chapter. Trimethylolethane (CAS Reg. No. 77–85–0) ...... For use only at levels not to exceed 0.45 percent by weight of inorganic pigment. The pigmented articles may contact all food under conditions of use A through H described in Table 2 of § 176.170(c) of this chapter.

[61 FR 43157, Aug. 21, 1996, as amended at 63 FR 35799, July 1, 1998; 64 FR 48292, Sept. 3, 1999; 64 FR 72273, Dec. 27, 1999; 65 FR 52909, Aug. 31, 2000]

§ 178.3730 Piperonyl butoxide and § 178.3740 Plasticizers in polymeric pyrethrins as components of bags. substances. Piperonyl butoxide in combination Subject to the provisions of this reg- with pyrethrins may be safely used for ulation, the substances listed in para- insect control on bags that are in- graph (b) of this section may be safely tended for use in contact with dried used as plasticizers in polymeric sub- feed in compliance with §§ 561.310 and stances used in the manufacture of ar- 561.340 of this chapter, or that are in- ticles or components of articles intended for use in contact with dried tended for use in producing, manufac- food in compliance with §§ 193.60 and turing, packing, processing, preparing, 193.390 of this chapter.

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treating, packaging, transporting, or to accomplish the intended technical holding food. effect. (a) The quantity used shall not ex- (b) List of substances: ceed the amount reasonably required

Substances Limitations

Butylbenzyl phthalate ...... For use only: 1. As provided in §§ 175.105 and 176.180 of this chapter. 2. In polymeric substances used in food-contact articles complying with § 175.300, § 175.320, or § 176.170 of this chapter: Provided, That the butyl benzyl phthalate contains not more than 1 percent by weight of dibenzyl phthalate. 3. In polymeric substances used in other permitted food-contact articles: Provided, That the butyl benzyl phthalate contains not more than 1 percent by weight of dibenzyl phthalate; and Provided further, That the finished food-contact article, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and temperature characterizing the conditions of its intended use as determined from tables 1 and 2 of § 175.300(d) of this chapter, shall yield net chloroform-soluble extractives not to exceed 0.5 mg. per square inch, as determined by the methods prescribed in § 175.300(e) of this chapter. 1,3-Butylene glycoladipic acid polyester (1,700– For use at levels not exceeding 33 percent by weight of polyvinyl chloride 2,200 molecular weight) terminated with a 16 homopolymers used in contact with food (except foods that contain more percent by weight mixture of myristic, palmitic, than 8 percent of alcohol) at temperatures not to exceed room tempera- and stearic acids. ture. The average thickness of such homopolymers in the form in which they contact food shall not exceed 0.004 inch.

Di(C7, C9-alkyl) adipate, in which the C7, C9-alkyl For use only under the conditions listed below, and excluding use as a groups are derived from linear alpha olefins by component of resinous and polymeric coatings described in § 175.300 of the oxo process. this chapter. 1. At levels not to exceed 24 percent by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 2. At levels not to exceed 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 3. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The average thickness of such polymer in the form in which they contact food shall not exceed 0.002 inch. 4. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch.

Di-n-alkyl adipate made from C6 C8-C10 (predomi- For use only: nately C8 and C10) or C8-C10 synthetic fatty alco- 1. At levels not exceeding 24 pct by weight of permitted vinyl chloride hols complying with § 172.864 of this chapter. homo- and/or copolymers used in contact with nonfatty foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 2. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 3. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch. 4. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in which they contact food shall not exceed 0.002 inch.

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Substances Limitations

Dicyclohexyl phthalate ...... For use only: 1. As provided in §§ 175.105, 176.170, 176.180, and 177.1200 of this chapter. 2. Alone or in combination with other phthalates, in plastic film or sheet prepared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. Such plastic film or sheet shall be used in contact with food at temperatures not to exceed room temperature and shall contain no more than 10 pct by weight of total phthalates, calculated as phthalic acid. Di(2-ethylhexyl) adipate ...... Diisononyl adipate ...... For use only: 1. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty, nonalcoholic foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 2. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact under conditions of use F and G described in table 2 of § 176.170(c) of this chapter with fatty, nonalcoholic foods having a fat and oil content not exceeding a total of 30 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 3. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty, nonalcoholic foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch. 4. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter with fatty, nonalcoholic foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch. Diisononyl phthalate ...... For use only at levels not exceeding 43 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, and VIII, at temperatures not exceeding room temperature. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. Di(2-ethylhexyl) azelate ...... For use only: 1. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty, nonalcoholic food. The average thickness of such polymers in the form in which they contact food shall not exceed 0.003 inch. 2. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter, with fatty, nonalcoholic food having a fat and oil content not exceeding a total of 30 percent by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.003 inch. Di-n-hexylazelate ...... For use only: 1. In polymeric substances used in contact with nonfatty food. 2. In polymeric substances used in contact with fatty food and limited to use at levels not exceeding 15 pct by weight of such polymeric substance except as provided under limitation 3. 3. At levels greater than 15 but not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F or G described in table 2 of § 176.170(c) of this chapter, with fatty food having a fat and oil content not exceeding a total of 30 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.003 inch. Dihexyl phthalate ...... For use only: 1. As provided in § 175.105 of this chapter. 2. In articles that contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV–B, VI–B, and VIII. Diphenyl phthalate ...... For use only: 1. As provided in § 175.105 of this chapter. 2. Alone or in combination with other phthalates, in plastic film or sheet prepared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. Such plastic film or sheet shall be used in contact with food at temperatures not to exceed room temperature and shall contain no more than 10 pct by weight of total phthalates, calculated as phthalic acid. Epoxidized butyl esters of linseed oil fatty acids .... Iodine number, maximum 5; oxirane oxygen, minimum 7.8 pct. Epoxidized linseed oil ...... Iodine number, maximum 5; oxirane oxygen, minimum 9-pct.

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Substances Limitations

Mineral oil, white. Polybutene, hydrogenated (minimum viscosity at For use only: 99 °F, 39 Saybolt Universal seconds, as deter- 1. In polymeric substances used in contact with non-fatty food. mined by ASTM methods D445–82 (‘‘Standard 2. In polyethylene complying with § 177.1520 of this chapter and used in Test Method for Kinematic Viscosity of Trans- contact with fatty food, provided that the hydrogenated polybutene is parent and Opaque Liquids (and the Calculation added in an amount not to exceed 0.5 pct by weight of the polyethylene, of Dynamic Viscosity)’’) and D2161–82 (‘‘Stand- and further provided that such plasticized polyethylene shall not be used ard Method for Conversion of Kinematic Vis- as a component of articles intended for packing or holding food during cosity to Saybolt Universal Viscosity or to cooking. Saybolt Furol Viscosity’’), and bromine number 3. In polystyrene complying with § 177.1640 of this chapter and used in of 3 or less, as determined by ASTM method contact with fatty food, provided that the hydrogenated polybutene is D1492–78 (‘‘Standard Test Method for Bromine added in an amount not to exceed 5 pct by weight of the polystyrene, Index of Aromatic Hydrocarbons by Coulometric and further provided that such plasticized polystyrene shall not be used Titration’’), which are incorporated by reference. as a component of articles intended for packing or holding food during Copies may be obtained from the American So- cooking. ciety for Testing Materials, 1916 Race St., Phila- delphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Polyisobutylene (mol weight 300–5,000) ...... For use in polyethylene complying with § 177.1520 of this chapter, provided that the polyisobutylene is added in an amount not exceeding 0.5 pct by weight of the polyethylene, and further provided that such plasticized polyethylene shall not be used as a component of articles intended for packing or holding food during cooking. Polyisobutylene complying with § 177.1420 of this chapter. Polypropylene glycol (CAS registry No. 25322–69– For use only in polystyrene plastics, identified in § 177.1640(a)(1), in an 4) (minimum mean molecular weight 1,200). amount not to exceed 6 pct by weight of the finished food-contact article. Propylene glycol azelate (average mol. weight For use only at levels not exceeding 41 pct by weight of permitted polyvinyl 3,000). chloride coatings. Such coatings shall be used only as bulk food contact surfaces of articles intended for repeated use, complying with § 177.2600 of this chapter. Triethylene glycol ...... Diethylene glycol content not to exceed 0.1 pct. 2,2,4-Trimethyl-1,3-pentanediol diisobutyrate ...... For use only in cellulosic plastics in an amount not to exceed 15 pct by weight of the finished food-contact article, provided that the finished plastic article contacts food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, VI–B, VII–B, and VIII.

(c) The use of the plasticizers in any ular weight is 350 or higher and no polymeric substance or article subject more than 0.5 percent total by weight to any regulation in parts 174, 175, 176, of ethylene and diethylene glycols if its 177, 178 and 179 of this chapter must mean molecular weight is below 350, comply with any specifications and when tested by the analytical methods limitations prescribed by such regula- prescribed in § 172.820(b) of this chapter. tion for the finished form of the sub- (c) The provisions of paragraph (b) of stance or article. this section are not applicable to poly- [42 FR 14609, Mar. 15, 1977, as amended at 42 ethylene glycols used in food-pack- FR 44223, Sept. 2, 1977; 45 FR 56052, Aug. 22, aging adhesives complying with 1980; 48 FR 5748, Feb. 15, 1984; 49 FR 10113, § 175.105 of this chapter. Mar. 19, 1984; 51 FR 47011, Dec. 30, 1986] § 178.3760 Polyethylene glycol (400) § 178.3750 Polyethylene glycol (mean monolaurate. molecular weight 200–9,500). Polyethylene glycol identified in this Polyethylene glycol (400) section may be safely used as a compo- monolaurate containing not more than nent of articles intended for use in con- 0.1 percent by weight of ethylene and/ tact with food, in accordance with the or diethylene glycol may be used at a following prescribed conditions: level not to exceed 0.3 percent by (a) The additive is an addition poly- weight of twine as a finish on twine to mer of ethylene oxide and water with a be used for tying meat provided the mean molecular weight of 200 to 9,500. twine fibers are produced from nylon (b) It contains no more than 0.2 per- resins complying with § 177.1500 of this cent total by weight of ethylene and chapter. diethylene glycols if its mean molec-

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§ 178.3770 Polyhydric alcohol esters of ican Society for Testing and Materials oxidatively refined (Gersthofen (ASTM), 1916 Race Street, Philadel- process) montan wax acids. phia, PA 19103, or available for inspec- Polyhydric alcohol esters of tion at the Office of the Federal Reg- oxidatively refined (Gersthofen proc- ister, 800 North Capitol Street, NW., ess) montan wax acids identified in this suite 700, Washington, DC 20408) using section may be safely used as compo- xylene-ethyl alcohol in a 2:1 ratio in- nents of articles intended for use in stead of ethyl alcohol in preparation of contact with food in accordance with potassium hydroxide solution. the following prescribed conditions: (4) Ultraviolet absorbance limits as (a) The polyhydric alcohol esters follows, as determined by the analyt- identified in this paragraph may be ical method described in this subpara- used as lubricants in the fabrication of graph: vinyl chloride plastic food-contact ar- Ultraviolet absorbance per centi- ticles prepared from polyvinyl chloride meter pathlength. and/or from vinyl chloride copolymers complying with § 177.1980 of this chap- Millimicrons Maximum ter. Such esters meet the following specifications and are produced by par- 280 to 289 ...... 0.07 290 to 299 ...... 06 tial esterification of oxidatively re- 300 to 359 ...... 04 fined (Gersthofen process) montan wax 360 to 400 ...... 01 acids by either ethylene glycol or 1,3- butanediol with or without neutraliza- ANALYTICAL METHOD tion of unreacted carboxylic groups with calcium hydroxide: GENERAL INSTRUCTIONS ° ° (1) Dropping point 76 –105 C, as de- Because of the sensitivity of the test, the termined by ASTM method D566–76 possibility of errors arising from contamina- (Reapproved 1982), ‘‘Standard Test tion is great. It is of the greatest importance Method for Dropping Point of Lubri- that all glassware be scrupulously cleaned to cating Grease,’’ which is incorporated remove all organic matter such as oil, by reference. Copies may be obtained grease, detergent residues, etc. Examine all from the American Society for Testing glassware, including stoppers and stopcocks, Materials, 1916 Race St., Philadelphia, under ultraviolet light to detect any residual fluorescent contamination. As a pre- PA 19103, or may be examined at the cautionary measure it is recommended prac- Office of the Federal Register, 800 tice to rinse all glassware with purified iso- North Capitol Street, NW., suite 700, octane immediately before use. No grease is Washington, DC 20408. to be used on stopcocks or joints. Great care (2) Acid value 10–20, as determined by to avoid contamination of wax samples in ASTM method D1386–78 (‘‘Standard handling and to assure absence of any extra- Test Method for Acid Number (Empir- neous material arising from inadequate ical) of Synthetic and Natural Waxes’’ packaging is essential. Because some of the polynuclear hydrocarbons sought in this test (Revised 1978), which is incorporated by are very susceptible to photo-oxidation, the reference; copies are available from entire procedure is to be carried out under American Society for Testing and Ma- subdued light. terials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available for APPARATUS inspection at the Office of the Federal Separatory funnels. 250-milliliter, 500-milli- Register, 800 North Capitol Street, liter, 1,000-milliliter, and preferably 2,000- NW., suite 700, Washington, DC 20408) milliliter capacity, equipped with tetra- using as solvent xylene-ethyl alcohol fluoroethylene polymer stopcocks. in a 2:1 ratio instead of toluene-ethyl Reservoir. 1,000-milliliter capacity, alcohol in a 2:1 ratio. equipped with a 24/40 standard taper male fit- (3) Saponification value 100–160, as ting at the bottom and a suitable balljoint at determined by ASTM method D1387–78 the top. (‘‘Standard Test Method for Saponi- Chromatographic tube. 1,200 millimeters in length, inside diameter to be 16.5 millimeters fication Number (Empirical) of Syn- ±0.5 millimeter, equipped with a coarse, frit- thetic and Natural Waxes’’ (Revised ted-glass disc, a tetrafluoroethylene polymer 1978), which is incorporated by ref- stopcock, and a female 24/40 standard tapered erence; copies are available from Amer- fitting at the opposite end. (Overall length of

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the column with the female joint is 1,255 mil- Wavelength accuracy, ±1.0 millimicron. limeters.) The female fitting should be Recording time, 50 seconds. equipped with glass hooks. Time constant, 0.6 second. Disc. Tetrafluoroethylene polymer 2-inch Sensitivity, 30. diameter disc approximately 3⁄16-inch thick Ordinate scale, 90–100 percent transmission with a hole bored in the center to closely fit through scale. the stem of the chromatographic tube. Abscissa scale, 8X. Heating jackets. Conical, for 500-milliliter Nitrogen cylinder. Water-pumped or equiva- and 1,000-milliliter separatory funnels. (Used lent purity nitrogen in cylinder equipped with variable transformer heat control.) with regulator and valve to control flow at 5 Suction flask. 250-milliliter or 500-milliliter p.s.i.g. filter flask. Condenser. 24⁄40 joints, fitted with a drying REAGENTS AND MATERIALS tube, length optional. Organic solvents. All solvents used through- Evaporation flasks (optional). A 250-milli- out the procedure shall meet the specifica- liter or 500-milliliter capacity and a 1-liter tions and tests described in this specifica- capacity all-glass flask equipped with stand- tion. The isooctane and benzene designated ard taper stopper having inlet and outlet in the list following this paragraph shall tubes to permit passage of nitrogen across pass the following test: the surface of contained liquid to be evapo- To be specified quantity of solvent in a 250- rated. milliliter Erlenmeyer flask, add 1 milliliter Vacuum distillation assembly. All glass (for of purified n-hexadecane and evaporate on purification of dimethyl sulfoxide) 2-liter the steam bath under a stream of nitrogen (a distillation flask with heating mantle; loose aluminum foil jacket around the flask Vigreaux vacuum-jacketed condenser (or will speed evaporation). Discontinue evapo- equivalent) about 45 centimeters in length ration when not over 1 milliliter of residue and distilling head with separable cold finger remains. (To the residue from benzene add a condenser. Use of tetrafluoroethylene poly- 10-milliliter portion of purified isooctane, re- mer sleeves on the glass joints will prevent evaporate, and repeat once to insure com- freezing. Do not use grease on stopcocks or plete removal of benzene.) joints. Alternatively, the evaporation time can be ° Oil bath. Capable of heating to 90 C. reduced by using the optional evaporation Spectrophotometric cells. Fused quartz cells, flask. In this case the solvent and n-hexa- optical pathlength in the range 1.000 centi- decane are placed in the flask on the steam ± meter 0.005 centimeter. With distilled water bath, the tube assembly is inserted, and a in the cells, determine any absorbance dif- stream of nitrogen is fed through the inlet ferences. tube while the outlet tube is connected to a Spectrophotometer. Spectral range 250 milli- solvent trap and vacuum line in such a way microns-400 millimicrons with spectral slit as to prevent any flow-back of condensate width of 0.2 millimicron or less; under in- into the flask. strument operating conditions for these ab- Dissolve the 1 milliliter of hexadecane res- sorbance measurements. The spectrophotom- idue in isooctane and make up to 25 milli- eter shall also meet the following perform- liters volume. Determine the absorbance in ance requirements: the 1-centimeter pathlength cells compared ± Absorbance repeatability, 0.01 at 0.4 ab- to isooctane as reference. The absorbance of sorbance. the solution of the solvent residue (except 1 ± Absorbance accuracy, 0.05 at 0.4 absorb- for methyl alcohol) shall not exceed 0.01 per ance. centimeter pathlength between 280 mµ and ± Wavelength repeatability, 0.2 milli- 400 mµ. micron. Isooctane (2,2,4-trimethylpentane). Use 180 milliliters for the test described in the pre- 1 As determined by procedure using potas- ceding paragraph. Purify, if necessary, by sium chromate for reference standard and passage through a column of activated silica described in National Bureau of Standards gel (Grade 12, Davison Chemical Co., Balti- Circular 484, Spectrometry, U.S. Department more, Md., or equivalent) about 90 centi- of Commerce (1949). The accuracy is to be de- meters in length and 5 centimeters to 8 cen- termined by comparison with the standard timeters in diameter. values at 290, 345, and 400 millimicrons. Cir- Benzene, A.C.S. reagent grade. Use 150 milli- cular 484 is incorporated by reference. Copies liters for the test. Purify, if necessary, by are available from the Center for Food Safe- distillation or otherwise. ty and Applied Nutrition (HFS–200), Food n-Hexadecane, 99 percent olefin-free. Dilute and Drug Administration, 5100 Paint Branch 1.0 milliliter of n-hexadecane to 25 milliliters Pkwy., College Park, MD 20740, or available with isooctane and determine the absorbance for inspection at the Office of the Federal in a 1-centimeter cell compared to isooctane Register, 800 North Capitol Street, NW., as reference point between 280 mµ-400 mµ. suite 700, Washington, DC 20408. The absorbance per centimeter pathlength

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shall not exceed 0.00 in this range. If nec- grams of Norit A (decolorizing carbon, alka- essary, purify by filtering through a column line) or equivalent. Stopper the flask, and containing 100 grams of aluminum oxide (use with the use of a magnetic stirrer (tetra- same grade as described below) in the lower fluoroethylene polymer coated bar) stir the half and 100 grams of activated silica gel in solvent for 15 minutes. Filter the dimethyl the upper half keeping the column at 150 °C., sulfoxide through four thicknesses of fluted for a period of 15 hours or overnight. The paper (18.5 centimeters, Schleicher & first 100 milliliters of eluate are used. Purifi- Schuell, No. 597, or equivalent). If the initial cation can also be accomplished by distilla- filtrate contains carbon fines, refilter tion. through the same filter until a clear filtrate Dimethyl sulfoxide. Pure grade, clear, is obtained. Protect the sulfoxide from air water-white, m.p. 18° minimum. Dilute 120 and moisture during this operation by cov- milliliters of dimethyl sulfoxide with 240 ering the solvent in the funnel and collection milliliters of distilled water in a 500-milli- flask with a layer of isooctane. Transfer the liter separatory funnel, mix and allow to filtrate to a 2-liter separatory funnel and cool for 5–10 minutes. Add 40 milliliters of draw off the dimethyl sulfoxide into the 2- isooctane to the solution and extract by liter distillation flask of the vacuum dis- shaking the funnel vigorously for 2 minutes. tillation assembly and distill at approxi- Draw off the lower aqueous layer into a sec- mately 3-millimeter Hg pressure or less. Dis- ond 500-milliliter separatory funnel and re- card the first 200-milliliter fraction of the peat the extraction with 40 milliliters of iso- distillate and replace the distillate collec- octane. Draw off and discard the aqueous tion flask with a clean one. Continue the dis- layer. Wash each of the 40-milliliter extrac- tillation until approximately 1 liter of the tives three times with 50-milliliter portions sulfoxide has been collected. of distilled water. Shaking time for each At completion of the distillation, the rea- wash is 1 minute. Discard the aqueous lay- gent should be stored in glass-stoppered bot- ers. Filter the first extractive through anhy- tles since it is very hygroscopic and will drous sodium sulfate prewashed with iso- react with some metal containers in the octane (see Sodium sulfate under ‘‘Reagents presence of air. and materials’’ for preparation of filter), into Phosphoric acid. 85 percent A.C.S. reagent a 250-milliliter Erlenmeyer flask, or option- grade. ally into the evaporating flask. Wash the Aluminum oxide (80–200 mesh Woelm neutral first separatory funnel with the second 40- activity grade 1 [Brockmann], Alupharm Chemi- milliliter isooctane extractive, and pass cals, New Orleans, La., or equivalent). Pipette through the sodium sulfate into the flask. 1 milliliter of distilled water into a dry 250- Then wash the second and first separatory milliliter Erlenmeyer flask equipped with a funnels successively with a 10-milliliter por- ground-glass stopper. Stopper the flask and tion of isooctane, and pass the solvent rotate it in such a manner as to completely through the sodium sulfate into the flask. wet out the inside surfaces. When this has Add 1 milliliter of n-hexadecane and evapo- been done add 180 grams of the aluminum rate the isooctane on the steam bath under oxide and shake until no lumps or wet spots nitrogen. Discontinue evaporation when not remain. Allow to stand at room temperature over 1 milliliter of residue remains. To the for a period of 2 hours. At the end of this residue, add a 10-milliliter portion of iso- time the water should be evenly distributed octane and reevaporate to 1 milliliter of throughout the aluminum oxide powder, and hexadecane. Again, add 10 milliliters of iso- it should have the same free flowing prop- octane to the residue and evaporate to 1 mil- erties as the original material (flow velocity liliter of hexadecane to insure complete re- with water 0.2 milliliter per minute). At this moval of all volatile materials. Dissolve the point the aluminum oxide has an activity of 1 milliliter of hexadecane in isooctane and 1 as expressed in Brockmann degrees, and make to 25-milliliter volume. Determine the the amount of added water is 0.5 percent by absorbance in 1-centimeter pathlength cells volume. This product is used in toto and as compared to isooctane as reference. The ab- is, without further screening. sorbance of the solution should not exceed Sodium sulfate, anhydrous, A.C.S. reagent 0.02 per centimeter pathlength in the 280 mµ- grade, preferably in granular form. For each 400 mµ range. (NOTE: Difficulty in meeting bottle of sodium sulfate reagent used, estab- this absorbance specification may be due to lish as follows the necessary sodium sulfate organic impurities in the distilled water. prewash to provide such filters required in Repetition of the test omitting the dimethyl the method: Place approximately 35 grams of sulfoxide will disclose their presence. If nec- anhydrous sodium sulfate in a 30-milliliter essary to meet the specification, purify the coarse, fritted-glass funnel or in a 65-milli- water by redistillation, passage through an meter filter funnel with glass wool plug; ion-exchange resin, or otherwise.) wash with successive 15-milliliter portions of Purify, if necessary, by the following pro- the indicated solvent until a 15-milliliter cedure: To 1,500 milliliters of dimethyl sulf- portion of the wash shows 0.00 absorbance oxide in a 2-liter glass-stoppered flask, add per centimeter pathlength between 280 mµ 6.0 milliliters of phosphoric acid and 50 and 400 mµ when tested as prescribed under

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‘‘Organic solvents.’’ Usually three portions Collect the successive extractives (300 mil- of wash solvent are sufficient. liliters total) in a separatory funnel (preferably 2-liter), containing 480 milliliters of PROCEDURE distilled water, mix, and allow to cool for a Before proceeding with analysis of a sam- few minutes after the last extractive has ple, determine the absorbance in a 1-centi- been added. Add 80 milliliters of isooctane to meter path cell between 250 mµ and 400 mµ the solution and extract by shaking the fun- for the reagent blank by carrying out the nel vigorously for 2 minutes. Draw off the procedure, without a wax sample, at room lower aqueous layer into a second separatory funnel (preferably 2-liter) and repeat the ex- temperature, recording the spectrum after traction with 80 milliliters of isooctane. the complete procedure as prescribed. The Draw off and discard the aqueous layer. absorbance per centimeter pathlength fol- Wash each of the 80-milliliter extractives lowing the complete procedure should not three times with 100-milliliter portions of exceed 0.04 in the wavelength range from 280 distilled water. Shaking time for each wash mµ to 299 mµ, inclusive, nor 0.02 in the wave- is 1 minute. Discard the aqueous layers. Fil- length range from 300 mµ to 400 mµ. If in ei- ter the first extractive through anhydrous ther spectrum the characteristic benzene sodium sulfate prewashed with isooctane (see peaks in the 250 mµ-260 mµ region are Sodium sulfate under ‘‘Reagents and Mate- present, remove the benzene by the proce- rials’’ for preparation of filter) into a 250- dure under ‘‘Organic solvents’’ and record milliliter Erlenmeyer flask (or optionally absorbance again. Place 300 milliliters of di- into the evaporation flask). Wash the first methyl sulfoxide in a 1-liter separatory fun- separatory funnel with the second 80-milli- nel and add 75 milliliters of phosphoric acid. liter isooctane extractive and pass through Mix the contents of the funnel and allow to the sodium sulfate. Then wash the second stand for 10 minutes. (The reaction between and first separatory funnels successively the sulfoxide and the acid is exothermic. Re- with a 20-milliliter portion of isooctane and lease pressure after mixing, then keep funnel pass the solvent through the sodium sulfate stoppered.) Add 150 milliliters of isooctane into the flask. Add 1 milliliter of n-hexa- and shake to preequilibrate the solvents. decane and evaporate the isooctane using an Draw off the individual layers and store in aspirator vacuum under nitrogen and in an glass-stoppered flasks. oil bath temperature of approximately 90 °C. In a 1-liter separatory funnel place a rep- Discontinue evaporation when not over 1 resentative 25-gram sample of wax, add 50 milliliter of residue remains. To the residue, milliliters of isooctane, heat gently, stir add a 10-milliliter portion of isooctane, re- until the wax is in solution; add 100 milli- evaporate to 1 milliliter of hexadecane, and liters of preequilibrated sulfoxide-phosphoric repeat this operation once. acid mixture and shake, making sure it re- Reserve the residue for column chroma- mains in solution. If the wax comes out of tography on the aluminum oxide. Fit the solution during these operations, let the tetrafluoroethylene polymer disc on the stoppered funnel remain in the jacket until upper part of the stem of the the wax redissolves. (Remove stopper from chromatographic tube, then place the tube the funnel at intervals to release pressure.) with the disc on the suction flask and apply When the wax is in solution, remove the fun- the vacuum (approximately 135 millimeters nel from the jacket and shake it vigorously Hg pressure). Weigh out 180 grams of the alu- for 2 minutes. Set up three 250-milliliter minum oxide and pour the adsorbent mixture separatory funnels with each containing 30 into the chromatographic tube in approxi- milliliters of preequilibrated isooctane. mately 30-centimeter layers. After the addi- After separation of the liquid phases, allow tion of each layer, level off the top of the ad- to cool until the main portion of the wax-iso- sorbent with a flat glass rod or metal plung- octane solution begins to show a precipitate. er by pressing down firmly until the adsorb- Gently swirl the funnel when precipitation ent is well packed. Loosen the topmost few first occurs on the inside surface of the fun- millimeters of each adsorbent layer with the nel to accelerate this process. Carefully draw end of a metal rod before the addition of the off the lower layer, filter it slowly through a next layer. Continue packing in this manner thin layer of glass wool fitted loosely in a fil- until all the 180 grams of the adsorbent is ter funnel into the first 250-milliliter sepa- added to the tube. Level off the top of the ad- ratory funnel, and wash in tandem with the sorbent by pressing down firmly with a flat 30-milliliter portions of isooctane contained glass rod or metal plunger to make the depth in the 250-milliliter separatory funnels. of the adsorbent bed approximately 80 centi- Shaking time for each wash is 1 minute. Re- meters in depth. Turn off the vacuum and repeat the extraction operation with two addi- move the suction flask. Dissolve the hexa- tional portions of the sulfoxide-acid mixture, decane residue in 10 milliliters of warm ben- replacing the funnel in the jacket after each zene and decant the solution onto the col- extraction to keep the wax in solution and umn and allow the liquid level to recede to washing each extractive in tandem through barely above the adsorbent level. Rapidly the same three portions of isooctane. complete the transfer similarly with two 10-

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milliliter portions of benzene swirling the reference; copies are available from flask repeatedly each time to assure ade- American Society for Testing and Ma- quate washing of the residue. Fix the 1,000- terials (ASTM), 1916 Race Street, milliliter reservoir onto the top of the chromatographic column. Just before the Philadelphia, PA 19103, or available for final 10-milliliter wash reaches the top of the inspection at the Office of the Federal adsorbent, add 670 milliliters of benzene to Register, 800 North Capitol Street, the reservoir and continue the percolation at NW., suite 700, Washington, DC 20408) the 2–3 milliliter per minute rate until a using as solvent xylene-ethyl alcohol total of 670 milliliters of benzene has been in a 2:1 ratio instead of toluene-ethyl utilized. Collect the eluate in a clean 1-liter alcohol in a 1:2 ratio. Erlenmeyer flask (or optionally into a 1-liter (3) Saponification value 135–150, as evaporation flask). Allow the column to drain until most of the solvent mixture is re- determined by ASTM method D1387–78 moved. Add 1 milliliter of n-hexadecane and (‘‘Standard Test Method for Saponi- completely remove the benzene by evapo- fication Number (Empirical) of Syn- ration under nitrogen, using the special pro- thetic and Natural Waxes’’ (Revised cedure to eliminate benzene as previously 1978), which is incorporated by ref- described under ‘‘Organic Solvents.’’ Quan- erence; copies are available from Amer- titatively transfer the residue with isooctane ican Society for Testing and Materials to a 25-milliliter volumetric flask and adjust (ASTM), 1916 Race Street, Philadel- to volume. Determine the absorbance of the solution in the 1-centimeter pathlength cells phia, PA 19103, or available for inspec- compared to isooctane as reference between tion at the Office of the Federal Reg- 250 mµ-400 mµ. Correct for any absorbance ister, 800 North Capitol Street, NW., derived from the reagents as determined by suite 700, Washington, DC 20408) using carrying out the procedure without a wax xylene-ethyl alcohol in a 2:1 ratio in- sample. If either spectrum shows the char- stead of ethyl alcohol in preparation of acteristic benzene peaks in the 250 mµ-260 mµ potassium hydroxide solution. region, evaporate the solution to remove (4) Ultraviolet absorbance limits benzene by the procedure under ‘‘Organic Solvents.’’ Dissolve the residue, transfer specified in paragraph (a)(4) of this sec- quantitatively, and adjust to volume in iso- tion, as determined by the analytical octane in a 25-milliliter volumetric flask. method described therein. Record the absorbance again. If the cor- (c) The polyhydric alcohol esters of rected absorbance does not exceed the limits oxidatively refined (Gersthofen proc- prescribed in paragraph (a) of this section, ess) montan wax acids, identified in the wax meets the ultraviolet absorbance paragraph (a) or (b) of this section, specifications. may also be used as a component of an (b) The polyhydric alcohol esters aqueous dispersion of vinylidene chlo- identified in this paragraph may be ride copolymers, subject to the condi- used as release agents in resinous and tions described in paragraphs (c) (1) polymeric coatings for polyolefin films and (2) of this section. complying with § 175.320 of this chapter. (1) The aqueous dispersion of the ad- Such esters meet the following speci- ditive contains not more that 18 per- fications and are produced by partial cent polyhydric alcohol esters of esterification of oxidatively refined oxidatively refined (Gersthofen proc- (Gersthofen process) montan wax acids ess) montan wax acids, not more than 2 with equimolar proportions of ethylene percent poly(oxyethylene) (minimum glycol and 1,3-butanediol: 20 moles of ethylene oxide) oleyl ether (1) Dropping point 77°–82 °C, as deter- (CAS Reg. No. 9005–98–2), and not more mined by ASTM method D566–76 (Re- than 1 percent poly(oxyethylene) (min- approved 1982), ‘‘Standard Test Method imum 3 moles ethylene oxide) cetyl al- for Dropping Point of Lubricating cohols (CAS Reg. No. 9004–95–9). Grease,’’ which is incorporated by ref- (2) The aqueous dispersion described erence. The availability of this incor- in paragraph (c)(1) of this section is poration by reference is given in para- used as an additive to aqueous disper- graph (a)(1) of this section. sions of vinylidene chloride copoly- (2) Acid value 25–35, as determined by mers, regulated in §§ 175.300, 175.320, ASTM method D1386–78 (‘‘Standard 175.360, 176.170, 176,180, and 177.1630 of Test Method for Acid Number (Empir- this chapter, at levels not to exceed 1.5 ical) of Synthetic and Natural Waxes’’ percent (solids basis) in the finished (Revised 1978), which is incorporated by coating.

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(d) The polyhydric alcohol esters § 178.3780 Polyhydric alcohol esters of identified in this paragraph may be long chain monobasic acids. used as lubricants in the fabrication of Polyhydric alcohol esters of long vinyl chloride plastic food contact arti- chain monobasic acids identified in cles prepared from vinyl chloride poly- this section may be safely used as lu- mers. Such esters meet the following bricants in the fabrication of polyvinyl specifications and are produced by par- chloride and/or polyvinyl chloride co- tial esterification of oxidatively re- polymer articles complying with fined (Gersthofen process) montan wax § 177.1980 of this chapter that contact acids with glycerol followed by neu- food of Types I, II, IV-B, VI-B, VII-B, tralization: and VIII identified in table 1 in (1) Dropping point 79 to 85 °C, as de- § 176.170(c) of this chapter under condi- termined by the American Society for tions of use E, F, and G described in Testing and Materials (ASTM), Method table 2 in § 176.170(c) of this chapter, subject to the provisions of this sec- D–566–76 (Reapproved 1982), ‘‘Standard tion. Test Method for Dropping Point of Lu- (a) Identity. For the purpose of this bricating Grease,’’ which is incor- section, polyhydric alcohol esters of porated by reference in accordance long chain monobasic acids consist of with 5 U.S.C. 552(a). The availability of polyhydric alcohol esters having num- this incorporation by reference is given ber average molecular weights in the in paragraph (a)(1) of this section. range of 1,050 to 1,700. The esters are (2) Acid value 20–30, as determined by produced by the reaction of either ASTM Method D–1386–78 ‘‘Standard ethylene glycol or glycerol with long Test Method for Acid Number (Empir- chain monobasic acids containing from ical) of Synthetic and Natural Waxes’’ 9 to 49 carbon atoms obtained by the (Revised 1978) (which is incorporated by ozonization of long chain alpha-olefins, reference in accordance with 5 U.S.C. the unreacted carboxylic acids in the 552(a); the availability of this incorpo- formation of the glycerol esters being ration by reference is given in para- neutralized with calcium hydroxide to graph (a)(2) of this section), using as a produce a composition having up to 2 solvent xylene-ethyl alcohol in a 2:1 percent by weight calcium. The alpha- ratio instead of toluene-ethyl alcohol olefins, obtained from the polymerization of ethylene, have 20 to 50 carbon in a 2:1 ratio. atoms and contain a minimum of 75 (3) Saponification value 130–160, as percent by weight straight chain alpha- determined by ASTM Method D–1387–78 olefins and not more than 25 percent ‘‘Standard Test Method for Saponifica- vinylidene compounds. tion Number (Empirical) of Synthetic (b) Specifications. The polyhydric al- and Natural Waxes’’ (Revised 1978), cohol esters have the following speci- (which is incorporated by reference in fications: accordance with 5 U.S.C. 552(a); the (1) Melting point of 60–80 °C for the availability of this incorporation by ethylene glycol ester and 90–105 °C for reference is given in paragraph (a)(3) of the glycerol ester as determined by the this section), using xylene-ethyl alco- Fisher Johns method as described in hol in a 2:1 ratio instead of ethyl alco- ‘‘Semimicro Qualitative Organic Anal- hol in the preparation of potassium hy- ysis—The Systematic Identification of droxide solution. Organic Compounds,’’ by Cheronis and (4) Ultraviolet absorbance limits Entrikin, 2d Ed., Interscience Pub- specified in paragraph (a)(4) of this sec- lishers, NY, which is incorporated by tion, as determined by the analytical reference. Copies are available from method described therein. the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug [42 FR 14609, Mar. 15, 1977, as amended at 47 Administration, 5100 Paint Branch FR 11848, Mar. 19, 1982; 49 FR 10113, Mar. 19, Pkwy., College Park, MD 20740, or 1984; 51 FR 33895, Sept. 24, 1986; 54 FR 24898, available for inspection at the Office of June 12, 1989; 55 FR 28020, July 9, 1990; 58 FR the Federal Register, 800 North Capitol 17512, Apr. 5, 1993] Street, NW., suite 700, Washington, DC 20408.

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(2) Acid value 15–25 for each ester as (i) Homopolymers and copolymers of determined by the A.O.C.S. method the following monomers: Trla-64T ‘‘Titer Test,’’ which is incor- n-Butyl acrylate. porated by reference. Copies are avail- n-Butyl methacrylate. able from American Association of Oil Ethyl acrylate. Chemists, 36 East Wacker Drive, Chi- Methyl methacrylate. cago, IL 60601, or available for inspection at the Office of the Federal Reg- (ii) Copolymers produced by co- ister, 800 North Capitol Street, NW., polymerizing one or more of the mono- suite 700, Washington, DC 20408. The mers listed in paragraph (a)(1)(i) of this method is modified to use as the acid section with one or more of the fol- solvent a 1:1 volume mixture of anhy- lowing monomers: drous isopropyl alcohol and toluene. Acrylonitrile. The solution is titrated with 0.1N Butadiene. methanolic sodium hydroxide. a-Methylstyrene. (3) Saponification value 120–160 for Styrene. the ethylene glycol ester and 90–130 for Vinylidene chloride. the glycerol ester as determined the (iii) Polymers identified in para- A.O.C.S. method Trla-64T ‘‘Saponifica- graphs (a)(1) (i) and (ii) of this section tion Value,’’ which is incorporated by containing no more than 5 weight-per- reference. Copies are available from cent of total polymer units derived by American Association of Oil Chemists, copolymerization with one or more of 36 East Wacker Drive, Chicago, IL the following monomers: 60601, or available for inspection at the Office of the Federal Register, 800 Acrylic acid. North Capitol Street, NW., suite 700, 1,3-Butylene glycol dimethacrylate. Washington, DC 20408. Divinylbenzene. Methacrylic acid. (4) Ultraviolet absorbance as specified in § 178.3770(a)(4) of this chapter (iv) Mixtures of polymers identified when tested by the analytical method in paragraph (a)(1) (i), (ii), and (iii) of described therein. this section; provided that no chemical reactions, other than addition reac- [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982; 54 FR 24899, June 12, tions, occur when they are mixed. 1989; 61 FR 14481, Apr. 2, 1996] (2) Polymers identified in paragraph (a)(1) of this section combined during § 178.3790 Polymer modifiers in their polymerization with butadiene- semirigid and rigid vinyl chloride styrene copolymers; provided that no plastics. chemical reactions, other than addi- The polymers identified in paragraph tion reactions, occur when they are (a) of this section may be safely combined. Such combined polymers admixed, alone or in mixture with may contain 50 weight-percent or more other permitted polymers, as modifiers of total polymer units derived from the in semirigid and rigid vinyl chloride butadiene-styrene copolymers. plastic food-contact articles prepared (b) The polymer content of the fin- from vinyl chloride homopolymers and/ ished plastic food-contact article con- or from vinyl chloride copolymers com- sists of: plying with § 177.1950, § 177.1970, and/or (1) Not less than 80 weight-percent of § 177.1980 of this chapter, in accordance polymer units derived from the vinyl with the following prescribed condi- chloride polymers identified in the in- tions: troduction to this section and not more (a) For the purpose of this section, than 5 weight-percent of polymer units the polymer modifiers are identified as derived from polymers identified in follows: paragraph (a)(1) of this section and (1) Acrylic polymers identified in this may optionally contain up to 15 subparagraph provided that such poly- weight-percent of polymer units de- mers contain at least 50 weight-percent rived from butadiene-styrene copoly- of polymer units derived from one or mers; or more of the monomers listed in para- (2) Not less than 50 weight-percent of graph (a)(1)(i) of this section. polymer units derived from the vinyl

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chloride polymers identified in the in- tractives not to exceed the limits pre- troduction to this section, not more scribed in § 177.1010 (b) (1), (2), (3), and than 50 weight-percent of polymer (4) of this chapter when tested by the units derived from homopolymers and/ methods prescribed in § 177.1010 (c) of or copolymers of ethyl acrylate and this chapter. methyl methacrylate, and not more (e) Acrylonitrile copolymers identi- than 30 weight-percent of polymer fied in this section shall comply with units derived from copolymers of meth- the provisions of § 180.22 of this chap- yl methacrylate, a-methylstyrene and ter. acrylonitrile and may optionally contain up to 15 weight-percent of polymer § 178.3800 Preservatives for wood. units derived from butadiene-styrene copolymers. Preservatives may be safely used on (c) No chemical reactions, other than wooden articles that are used or in- addition reactions, occur among the tended for use in packaging, trans- vinyl chloride polymers and the modi- porting, or holding raw agricultural fying polymers present in the polymer products subject to the provisions of mixture used in the manufacture of the this section: finished plastic food-contact article. (a) The preservatives are prepared (d) The finished plastic food-contact from substances identified in para- article, when extracted with the sol- graph (b) of this section and applied in vent or solvents characterizing the amounts not to exceed those necessary type of food and under the conditions to accomplish the technical effect of of time and temperature characterizing protecting the wood from decay, mil- the conditions of its intended use as de- dew, and water absorption. termined from tables 1 and 2 of (b) The substances permitted are as § 176.170(c) of this chapter, yields ex- follows:

List of substances Limitations

Copper-8-quinolinolate. Mineral spirits. Paraffin wax ...... Used singly or in combination so as to constitute not less than 50% of the solids. Petroleum hydrocarbon resin, produced by the homo- and co- Do. polymerization of dienes and olefins of the aliphatic, alicyclic, and monobenzenoid arylalkene type from distillates of cracked petroleum stocks. Pentachlorophenol and its sodium salt ...... Not to exceed 50 p.p.m. in the treated wood, calculated as pentachlorophenol. Rosins and rosin derivatives ...... As provided in § 178.3870. Zinc salt of sulfonated petroleum.

§ 178.3850 Reinforced wax. physical or technical effect or any limitation provided in this section. Reinforced wax may be safely used as (c) Any substance employed in the an article or component of articles in- production of reinforced wax, including tended for use in producing, manufac- any optional substance, that is the sub- turing, packing, processing, trans- ject of a regulation in parts 174, 175, porting, or holding food subject to the 176, 177, 178 and § 179.45 of this chapter, provisions of this section. conforms with any specification in (a) Reinforced wax consists of petro- such regulation. leum wax to which have been added (d) The substances and optional adju- certain optional substances required in vant substances employed in the pro- its production, or added to impart de- duction of or added to reinforced wax sired physical or technical properties. include: (b) The quantity of any optional ad- (1) Substances generally recognized juvant substance employed in the pro- as safe in food. duction of or added to reinforced wax does not exceed the amount reasonably (2) Substances subject to prior sanc- required to accomplish the intended tion for use in reinforced wax and used

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in accordance with such sanction or ap- at 70 °F for 48 hours shall not exceed 0.5 proval. milligram per square inch of food-con- (3) Substances identified in this sub- tact surface. paragraph and subject to any limita- (2) It is used as a packaging material tions provided therein: or component of packaging materials for cheese and cheese products. List of substances Limitations [42 FR 14609, Mar. 15, 1977, as amended at 47 Copolymer of isobutylene modified with isoprene. FR 1288, Jan. 12, 1982] Petroleum wax, Type I and Type II. § 178.3860 Release agents. Polyethylene. Rosins and rosin derivatives as Substances listed in paragraph (b) of provided in § 178.3870. this section may be safely used as re- Synthetic wax polymer as de- Not to exceed 5 percent lease agents in petroleum wax com- scribed in § 176.170(a)(5) of by weight of the petro- this chapter. leum wax. plying with § 178.3710 and in polymeric resins that contact food, subject to the (e) Reinforced wax conforming with provisions of this section. the specifications in this paragraph is (a) The quantity used shall not ex- used as provided in paragraph (e)(2) of ceed the amount reasonably required this section. to accomplish the intended technical (1) The chloroform-soluble portion of effect or any limitations prescribed in the water extract obtained by exposing this section. reinforced wax to demineralized water (b) Release agents:

List of substances Limitations

Erucamide (erucylamide). Formaldehyde, polymer with 1-naphthalenol (CAS For use only as an antiscaling or release agent, applied on the internal Reg. No. 25359–91–5). parts of reactors employed in the production of polyvinyl chloride and acrylic copolymers, provided that the residual levels of the additive in the ploymer do not exceed 4 parts per million. N,N′-Dioleoylethylenediamine ...... For use only in polyvinyl chloride films in amounts such that the concentration of the substance in these films in the form in which the films contact food shall not exceed 0.055 milligram of the substance per square inch of film. Oleyl palmitamide. Polybutene, hydrogenated; complying with the For use only subject to the limitations prescribed for hydrogenated identity prescribed under § 178.3740(b). polybutene under § 178.3740(b). Poly(vinyl acetate/vinyl N-octadecylcarbamate) For use only in application to the backing of pressuresensitive adhesive (CAS Reg. No. 70892–21–6) produced by the tapes at levels not to exceed 0.2 milligram per square centimeter (1.29 reaction between stoichiometrically equivalent milligrams per square inch) of backing. amounts of octadecyl isocyanate and vinyl alcohol/vinyl acetate copolymer; minimum average molecular weight is 500,000. Rice bran wax ...... For use only in plastics intended for contact with dry foods identified as Type VIII in table 1 of § 176.170(c) of this chapter, at levels not in excess of 1.0 percent by weight of the polymer. Saturated fatty acid amides manufactured from fatty acids derived from animal, marine, or vegetable fats and oils. Stearyl erucamide.

[42 FR 14609, Mar. 15, 1977, as amended at 44 FR 69649, Dec. 4, 1979; 46 FR 51902, Oct. 23, 1981; 61 FR 25396, May 21, 1996; 61 FR 42381, Aug. 15, 1996]

§ 178.3870 Rosins and rosin deriva- holding food, subject to the provisions tives. of this section. The rosins and rosin derivatives iden- (a) The rosins and rosin derivatives tified in paragraph (a) of this section are identified as follows: may safely be used in the manufacture (1) Rosins: of articles or components of articles in- (i) Gum rosin, refined to color grade tended for use in producing, manufac- of K or paler. turing, packing, processing, preparing, (ii) Wood rosin, refined to color grade treating, packaging, transporting, or of K or paler.

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(iii) Tall oil rosin, refined to color of 3 to 8, a drop-softening point of 109°– grade of K or paler. 119 °C, and a color of M or paler. (iv) Dark tall oil rosin, a fraction re- (iv) Glycerol ester of fully dimerized sulting from the refining of tall oil rosin, having an acid number of 5 to 16, rosin produced by multicolumnar dis- a drop-softening point of 165°–175 °C, tillation of crude tall oil to effect re- and a color of H or paler. moval of fatty acids and pitch compo- (v) Glycerol ester of maleic anhy- nents and having a saponification num- dride-modified wood rosin, having an ber of from 110–135 and 32 percent–44 acid number of 30 to 40, a drop-soft- percent rosin acids. ening point of 138°–146 °C, a color of M (v) Dark wood rosin, all or part of the or paler, and a saponification number residue after the volatile terpene oils less than 280. are distilled from the oleoresin ex- (vi) Methyl ester of rosin, partially tracted from pine wood. hydrogenated, purified by steam strip- (2) Modified rosins manufactured ping to have an acid number of 4 to 8, from rosins identified in paragraph a refractive index of 1.5170 to 1.5205 at (a)(1) of this section: 20 °C, and a viscosity of 23 to 66 poises (i) Partially hydrogenated rosin, cat- at 25 °C. alytically hydrogenated to a maximum (vii) Pentaerythritol ester of wood refractive index of 1.5012 at 100 °C, and rosin, having an acid number of 6 to 16, a color of WG or paler. a drop-softening point of 109°–116 °C, (ii) Fully hydrogenated rosin, cata- and a color of M or paler. lytically hydrogenated to a maximum (viii) Pentaerythritol ester of par- dehydroabietic acid content of 2 per- tially hydrogenated wood rosin, having cent, a minimum drop-softening point an acid number of 7 to 18, a drop-soft- of 79 °C, and a color of X or paler. ening point of 102°–110 °C, and a color of (iii) Partially dimerized rosin, K or paler. dimerized by sulfuric acid catalyst to a (ix) Pentaerythritol ester of maleic drop-softening point of 95°–105 °C and a anhydride-modified wood rosin, having color of WG or paler. an acid number of 8 to 16, a drop-soft- (iv) Fully dimerized rosin, dimerized ening point of 154°–162 °C, a color of M by sulfuric acid catalyst, and from or paler, and having a saponification which sufficient nondimerized rosin number less than 280. has been removed by distillation to (x) Pentaerythritol ester of maleic achieve a minimum drop-softening anhydride-modified wood rosin, having point of 143 °C, and a color of H or an acid number of 9 to 16, a drop-soft- paler. ening point of 130°–140 °C, a color of N (v) Disproportionated rosin, catalyt- or paler, and having a saponification ically disproportionated to a minimum number less than 280. dehydroabietic acid content of 35 per- (xi) Pentaerythritol ester of maleic cent, a maximum abietic acid content anhydride-modified wood rosin, having of 1 percent, a maximum content of an acid number of 134 to 145, a drop- substituted phenanthrenes (as retene) softening point of 127°–137 °C, a color of of 0.25 percent, and a color of WG or M or paler, and having a saponification paler. number less than 280. (3) Rosin esters manufactured from (xii) Pentaerythritol ester of maleic rosins and modified rosins identified in anhydride-modified wood rosin, having paragraphs (a)(1) and (2) of this section: an acid number of 30 to 40, a drop-soft- (i) Glycerol ester of wood rosin puri- ening point of 131°–137 °C, a color of N fied by steam stripping to have an acid or paler, and having a saponification number of 3 to 9, a drop-softening point number less than 280. of 88°–96 °C, and a color of N or paler. (xiii) Pentaerythritol ester of maleic (ii) Glycerol ester of partially hydro- anhydride-modified wood rosin, further genated wood rosin, having an acid modified by reaction with 4,4′-iso- number of 3 to 10, a drop-softening propyl-idenediphenol-formaldehyde point of 79°–88 °C, and a color of N or condensate, having an acid number of paler. 10 to 22, a drop-softening point of 162°– (iii) Glycerol ester of partially 172 °C, a color of K or paler, a saponi- dimerized rosin, having an acid number fication number less than 280, and a

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maximum ultraviolet absorbance of (iii) Maleic anhydride. 0.14 at 296 mµ (using a 1-centimeter cell (iv) Saligenin. and 200 milligrams of the rosin ester (b) The quantity used shall not ex- per liter of solvent consisting of ethyl ceed the amount reasonably required alcohol made alkaline by addition of to accomplish the intended technical 0.1 percent of potassium hydroxide). effect. (xiv) Mixed methyl and pentaeryth- (c) The use in any substance or arti- ritol ester of maleic anhydride-modi- cle that is the subject of a regulation fied wood rosin, having an acid number in parts 174, 175, 176, 177, 178 and § 179.45 of 73 to 83, a drop-softening point of of this chapter shall conform with any 113°–123 °C, a color of M or paler, and a specifications and limitations pre- saponification number less than 280. scribed by such regulation for the fin- (xv) Triethylene glycol ester of par- ished form of the substance or article. tially hydrogenated wood rosin, having (d) The provisions of this section are an acid number of 2 to 10, a color of K not applicable to rosins and rosin de- or paler, and a viscosity of 350 to 425 rivatives identified in § 175.300(b)(3)(v) seconds Saybolt at 100 °C. of this chapter and used in resinous (xvi) Glycerol ester of maleic anhy- and polymeric coatings complying with dride-modified wood rosin, having an § 175.300 of this chapter. acid number of 17 to 23, a drop-soft- (e) The provisions of this section are ening point of 136°–140 °C, a color of M not applicable to rosins and rosin de- or paler, and a saponification number rivatives identified in § 175.105(c)(5) of less than 280. For use only in cello- this chapter and used in defoaming phane complying with § 177.1200 of this agents complying with § 176.210 of this chapter. chapter, food-packaging adhesives (xvii) Citric acid-modified glycerol complying with § 175.105 of this chapter, ester of rosin, having an acid number and rubber articles complying with less than 20, a drop-softening point of § 177.2600 of this chapter. 105°–115 °C, and a color of K or paler. (f) The analytical methods for deter- For use only as a blending agent in mining whether rosins and rosin de- coatings for cellophane complying with rivatives conform to the specifications § 177.1200 of this chapter. prescribed in paragraph (a) of this sec- (xviii) Glycerol ester of tall oil rosin, tion are as follows: purified by steam stripping to have an (1) Color: Color shall be as deter- acid number of 5–12, a softening point mined by ASTM method D509–70 (Re- of 80°–88 °C, and a color of N or paler. approved 1981), ‘‘Standard Methods of (xix) Glycerol ester of maleic anhy- Sampling and Grading Rosin,’’ which is dride-modified tall oil rosin, having an incorporated by reference. Copies may acid number of 30 to 40, a drop-soft- be obtained from the American Society ening point of 141°–146 °C, a color of N for Testing Materials, 1916 Race St., or paler, and a saponification number Philadelphia, PA 19103, or may be ex- less than 280. amined at the Office of the Federal (xx) Glycerol ester of Register, 800 North Capitol Street, disproportionated tall oil rosin, having NW., suite 700, Washington, DC 20408. an acid number of 5 to 10, a drop-soft- (2) Refractive index: Refractive index ening point of 84°–93 °C, a color of WG shall be as determined by ASTM meth- or paler, and a saponification number od D1747–62 (Reapproved 1978), ‘‘Stand- less than 180. ard Test Method for Refractive Index of (4) Rosin salts and sizes—Ammo- Viscous Materials,’’ which is incor- nium, calcium, potassium, sodium, or porated by reference. The availability zinc salts of rosin manufactured by the of this incorporation by reference is partial or complete saponification of given in paragraph (f)(1) of this section. any one of the rosins or modified rosins (3) Acid number: Acid number shall identified in paragraph (a)(1) and (2) of be as determined by ASTM method this section, or blends thereof, and D465–82, ‘‘Standard Test Methods for with or without modification by reac- Acid Number of Rosin,’’ which is incor- tion with one or more of the following: porated by reference. The availability (i) Formaldehyde. of this incorporation by reference is (ii) Fumaric acid. given in paragraph (f)(1) of this section.

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(4) Viscosity: Viscosity in poises inspection at the Office of the Federal shall be as determined by ASTM meth- Register, 800 North Capitol Street, od D1824–66 (Reapproved 1980), ‘‘Stand- NW., suite 700, Washington, DC 20408. ard Test Method for Apparent Vis- cosity of Plastisols and Organosols at [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982; 49 FR 10113, Mar. 19, Low Shear Rates by Brookfield Vis- 1984; 54 FR 24899, June 12, 1989] cometer,’’ and in Saybolt seconds by ASTM method D88–81, ‘‘Standard Test § 178.3900 Sodium Method for Saybolt Viscosity,’’ which pentachlorophenate. are incorporated by reference. The Sodium pentachlorophenate may be availability of this incorporation by safely used as a preservative for ammo- reference is given in paragraph (f)(1) of nium alginate employed as a proc- this section. essing aid in the manufacture of poly- (5) Softening point: Softening point shall be as determined by ASTM meth- vinyl chloride emulsion polymers in- od E28–67, ‘‘Standard Test Method for tended for use as articles or compo- Softening Point by Ring and Ball Ap- nents of articles that contact food at paratus’’ (Reapproved 1977), which is temperatures not to exceed room tem- incorporated by reference. Copies are perature. The quantity of sodium available from American Society for pentachlorophenate used shall not ex- Testing and Materials (ASTM), 1916 ceed 0.5 percent by weight of ammo- Race St., Philadelphia, PA 19103, or nium alginate solids. available for inspection at the Office of § 178.3910 Surface lubricants used in the Federal Register, 800 North Capitol the manufacture of metallic arti- Street, NW., suite 700, Washington, DC cles. 20408. (6) Analytical methods for deter- The substances listed in this section mining drop-softening point, saponi- may be safely used in surface lubri- fication number, and any other speci- cants employed in the manufacture of fications not listed under paragraphs metallic articles that contact food, (f)(1) through (5) of this section, titled: subject to the provisions of this sec- (i) ‘‘Determination of Abeitic Acid and tion. Dehydroabietic Acid in Rosins’’; (ii) (a) The following substances may be ‘‘Determination of Softening Point of used in surface lubricants used in the Solid Resins’’; (iii) ‘‘Determination of rolling of metallic foil or sheet stock Saponification Number of Rosin provided that total residual lubricant Esters,’’ and (iv) ‘‘Determination of remaining on the metallic article in Phenolic Modification of Rosin Deriva- the form in which it contacts food does tives,’’ which are incorporated by ref- not exceed 0.015 milligram per square erence. Copies are available from the inch of metallic food-contact surface: Center for Food Safety and Applied Nu- (1) Substances identified in para- trition (HFS–200), Food and Drug Ad- graphs (b)(1) and (2) of this section. ministration, 5100 Paint Branch Pkwy., (2) Substances identified in this para- College Park, MD 20740, or available for graph.

List of substances Limitations

a-Butyl-W-–hydroxypoly (oxyethylene)-poly (oxypropylene) (CAS Reg. No. 9038–95–3) produced by random condensation of a 1:1 mixture by weight of ethylene oxide and propylene oxide with butanol and having a minimum molecular weight of 1,000. a–Butyl–W–hydroxypoly(oxypropylene) (CAS Reg. No. 9003- 13–8) having a minimum molecular weight of 1000. a–Lauroyl–W–hydroxpoly(oxyethylene) (CAS Reg. No. 9004– 81–3) having a minimum molecular weight of 200. Acetate esters derived from synthetic straight chain alcohols (complying with § 172.864 of this chapter) that have even numbers of carbon atoms in the range C8-C18. alpha-Alkyl–omega-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of C12-C15 straight chain primary alcohols with an average of 3 moles of ethylene oxide (CAS Reg. No. 6002–97–1). Benzotriazole (CAS Reg. No. 95–14–7) ......

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List of substances Limitations

Bis(hydrogenated tallow alkyl)amine (CAS Reg. No. 61789– Not to be used in combination with sodium nitrite. 79–5). Bis(hydrogenated tallow alkyl)aminoethanol (CAS Reg. No. 116438–56–3). N,N-Bis(2-hydroxyethyl)butylamine (CAS Reg. No. 102–79–4) Tert-Butyl alcohol. Di(2-ethylhexyl)phthalate. Diethyl phthalate. Diethylene glycol monobutylether (CAS Reg. No. 112–34–5) .... Dimers, trimers, and/or their partial methyl esters; such dimers For use only at a level not to exceed 10 percent by weight of and trimers are of unsaturated C18 fatty acids derived from finished lubricant formulation. animal and vegetable fats and oils and/or tall oil, and such partial methyl esters meet the following specifications: Sa- ponification value 180–200, acid value 70–130, and maximum iodine value 120. Di-n-octyl sebacate. Ethylenediaminetetraacetic acid, sodium salts. Isopropyl alcohol. Isopropyl laurate (CAS Reg. No. 10233–13–3) ...... For use at a level not to exceed 10 percent by weight of the finished lubricant formulation. Isopropyl oleate. Isotridecyl alcohol, ethoxylated (CAS Reg. No. 9043–30–5). Methyl esters of coconut oil fatty acids. Methyl esters of fatty acids (C16-C18) derived from animal and vegetable fats and oils. Polybutene, hydrogenated: complying with the identity prescribed under § 178.3740(b). Polyethylene glycol (400) monostearate. Polyisobutylene (minimum molecular weight 300). Polyoxyethylated (5 moles) tallow amine (CAS Reg. No. 61791–26–2). Polyvinyl alcohol. Sodium nitrite ...... For use only as a rust inhibitor in lubricant formulations provided the total residual sodium nitrite on the metallic article in the form in which it contacts food does not exceed 0.007 milligram per square inch of metallic food-contact surface. Sodium petroleum sulfonate, MW 440–450 (CAS Reg. No. 68608–24–4) derived from naphthenic oil having a Saybolt viscosity range of 500–600 Saybolt Universal Seconds (SUS at 37–8 °C (100 °F) as determined by ASTM method D88– 81, ‘‘Standard Test Method for Saybolt Viscosity,’’ which is incorporated by reference. Copies are available from the American Society for Testing Materials, 1961 Race St., Philadelphia, PA 19103, or available for inspection at the Of- fice of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Synthetic alcohol mixture of straight-and branched-chain alcohols that have even numbers of carbon atoms in the range C4C18 and that are prepared from ethylene, aluminum, and hydrogen such that the finished synthetic alcohol mixture contains not less than 75 pct of straight-chain primary alcohols and contains not less than 85 pct total C10 and C12 alcohols. Synthetic primary alcohol mixture of straight- and branched- For use at a level not to exceed 8 pct by weight of the finished chain alcohols that contain at least 99 pct primary alcohols lubricant formulation. consisting of the following: not less than 70 pct normal alcohols; not less than 96.5 pct C12-C15 alcohols; and not more than 2.5 pct alpha, omega C13-C16 diols. The alcohols are prepared from linear olefins from a purified kerosene fraction, carbon monoxide and hydrogen using a modified oxo process, such that the finished primary alcohol mixture meets the following specifications: Molecular weight, 207±4; hydroxyl number, 266–276. Synthetic primary alcohol mixture of straight- and branched- For use only at a level not to exceed 8 pct by weight of the fin- chain alcohols that contain at least 99 pct primary alcohols ished lubricant formulation. consisting of the following: not less than 70 percent normal alcohols; not less than 93 pct C12-C13 alcohols; not more than 5 pct C14-C15 alcohols; and not more than 2.5 pct alpha, omega, C13-C16 diols. The alcohols are prepared from linear olefins from a purified kerosene fraction, carbon monoxide and hydrogen using a modified oxo process, such that the finished primary alcohol mixture meets the following specifications: Molecular weight 194±5; hydroxyl number, 283–296.

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List of substances Limitations

Tallow, sulfonated. Triethanolamine.

(3) Mineral oil conforming to the corporated by reference. The avail- identity prescribed in § 178.3620(c). ability of this incorporation by ref- (4) Light petroleum hydrocarbons erence is given in paragraph (a)(4)(i)(a) identified in paragraph (a)(4) (i) of this of this section. section: Provided, That the total resid- (d) Aromatic component content ual lubricant on the metallic article in shall not exceed 32 percent. the form in which it contacts food (e) Conforms with ultraviolet absorb- meets the ultraviolet absorbance lim- ance limits prescribed in § 178.3620(c) as its prescribed in paragraph (a) (4) (ii) of determined by the analytical method this section as determined by the ana- described therein. lytical method described in paragraph (ii) Ultraviolet absorbance limits on (a) (4) (iii) of this section. residual lubricants are as follows: (i) Light petroleum hydrocarbons are Maximum derived by distillation from virgin pe- absorb- troleum stocks or are synthesized from ance per 5 Wavelength (mµ) centi- petroleum gases. They are chiefly par- meters op- affinic, isoparaffinic, napthenic, or aro- tical pathlength matic in nature, and meet the following specifications: 280–289 ...... 0.7 (a) Initial boiling point is 24 °C min- 290–299 ...... 6 300–359 ...... 4 imum and final boiling point is 288 °C 360–400 ...... 09 maximum, as determined by ASTM method D86–82, ‘‘Standard Method for (iii) The analytical method for deter- Distillation of Petroleum Products,’’ mining ultraviolet absorbance limits which is incorporated by reference. on residual lubricants is as follows: Copies may be obtained from the Amer- ican Society for Testing Materials, 1916 GENERAL INSTRUCTIONS Race St., Philadelphia, PA 19103, or Because of the sensitivity of the test, the may be examined at the Office of the possibility of errors arising from contamina- Federal Register, 800 North Capitol tion is great. It is of the greatest importance Street, NW., suite 700, Washington, DC that all glassware be scrupulously cleaned to 20408. remove all organic matter such as oil, grease, detergent, residues, etc. Examine all (b) Nonvolatile residue is 0.005 gram glassware including stoppers and stopcocks, per 100 milliliters, maximum, as deter- under ultraviolet light to detect any residual mined by ASTM method D381–80, fluorescent contamination. As a pre- ‘‘Standard Test Method for Existent cautionary measure it is recommended prac- Gum in Fuels by Jet Evaporation,’’ tice to rinse all glassware with purified iso- when the final boiling point is 121 °C or octane immediately before use. No grease is above and by ASTM method D1353–78, to be used on stopcocks or joints. Great care to avoid contamination of oil samples in ‘‘Standard Test Method for Nonvolatile handling and to assure absence of any extra- Matter in Volatile Solvents for Use in neous material arising from inadequate Paint, Varnish, Lacquer, and Related packaging is essential. Because some of the Products,’’ when the final boiling point polynuclear hydrocarbons sought in this test is below 121 °C. These ASTM methods are very susceptible to photo-oxidation, the are incorporated by reference. The entire procedure is to be carried out under availability of these incorporations by subdued light. reference is given in paragraph APPARATUS (a)(4)(i)(a) of this section. (c) Saybolt color 20 minimum as de- Separatory funnels. 250-milliliter, 500-milliliter, 1,000-milliliter, and preferably 2,000- termined by ASTM method D156–82, milliliter capacity, equipped with tetra- ‘‘Standard Test Method for Saybolt fluoroethylene polymer stopcocks. Color of Petroleum Products (Saybolt Evaporation flask (optional). 250-milliliter or Chromometer Method),’’ which is in- 500-milliliter capacity all-glass flask

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equipped with standard-taper stopper having flask. In this case the solvent and n-hexa- inlet and outlet tubes to permit passage of decane are placed in the flask on the steam nitrogen across the surface of contained liq- bath, the tube assembly is inserted, and a uid to be evaporated. stream of nitrogen is fed through the inlet Spectrophotometric cells. Fused quartz cells, tube while the outlet tube is connected to a optical path length in the range of 5,000 cen- solvent trap and vacuum line in such a way timeters ±0.005 centimeter; also for checking as to prevent any flow-back of condensate spectrophotometer performance only, optical into the flask. path length in the range 1.000 centimeter Dissolve the 1 milliliter of hexadecane res- ± 0.005 centimeter. With distilled water in the idue in isooctane and make to 25 milliliters cells, determine any absorbance differences. volume. Determine the absorbance in the 5- Spectrophotometer. Special range 250 centimeter path length cells compared to millicrons-400 millimicrons with spectral slit isooctane as reference. The absorbance of the width of 2 millimicrons or less; under instru- solution of the solvent residue shall not ex- ment operating conditions for these absorb- ceed 0.01 per centimeter path length between ance measurements, the spectrophotometer 280 and 400 mµ. Purify, if necessary, by pas- shall also meet the following performance sage through a column of activated silica gel requirements: (Grade 12, Davison Chemical Co., Baltimore, Absorbance repeatability, ±0.01 at 0.4 ab- Maryland, or equivalent) about 90 centi- sorbance. meters in length and 5 centimeters to 8 cen- Absorbance accuracy, 1 ±0.05 at 0.4 absorb- timeters in diameter. ance. Wavelength repeatability, ±0.2 milli- n-Hexadecane, 99-percent olefin-free. Dilute micron. 1.0 milliliter of n-hexadecane to 25 milliliters Wavelength accuracy, ±1.0 millimicron. with isooctane and determine the absorbance Soxhlet apparatus. 60-millimeter diameter in a 5-centimeter cell compared to isooctane body tubes fitted with condenser and 500-mil- as reference point between 280 mµ-400 mµ. liliter round-bottom boiling flask. A supply The absorbance per centimeter path length of paper thimbles to fit is required. shall not exceed 0.00 in this range. Purify, if Nitrogen cylinder. Water-pumped or equiva- necessary, by percolation through activated lent purity nitrogen in cylinder equipped silica gel or by distillation. with regulator and valve to control flow at 5 Dimethyl sulfoxide. Spectrophotometric p.s.i.g. grade (Crown Zellerbach Corp., Camas, Washington, or equivalent). Absorbance (1- REAGENTS AND MATERIALS centimeter cell, distilled water reference, Organic solvents. All solvents used through- sample completely saturated with nitrogen). out the procedure shall meet the specifications and tests described in this specifica- Absorb- Wavelength ance (max- tion. The isooctane (2,2,4-trimethylpentane) imum) shall pass the following test: Place 180 milliliters of solvent in a 250-mil- 261.5 ...... 1.00 liliter Erlenmeyer flask, add 1 milliliter of 270 ...... 20 purified n-hexadecane and evaporate on the 275 ...... 09 steam bath under a stream of nitrogen (a 280 ...... 06 loose aluminum foil jacket around the flask 300 ...... 015 will speed evaporation). Discontinue evaporation when not over 1 milliliter of residue There shall be no irregularities in the ab- remains. sorbance curve within these wavelengths. Alternatively, the evaporation time can be Phosphoric acid. 85 percent A.C.S. reagent reduced by using the optional evaporation grade. Sodium sulfate, anhydrous, A.C.S. reagent 1 As determined by procedure using potas- grade, preferably in granular form. For each sium chromate for reference standard and bottle of sodium sulfate reagent used, estab- described in National Bureau of Standards lish as follows the necessary sodium sulfate Circular 484, Spectrometry, U.S. Department prewash to provide such filters required in of Commerce (1949), which is incorporated by the method: Place approximately 35 grams of reference. Copies are available from the Cen- anhydrous sodium sulfate in a 30-milliliter ter for Food Safety and Applied Nutrition coarse, fritted-glass funnel or in a 65-milli- (HFS–200), Food and Drug Administration, liter filter funnel with glass wool plug; wash 5100 Paint Branch Pkwy., College Park, MD with successive 15-milliliter portions of the 20740, or available for inspection at the Office indicated solvent until a 15-milliliter portion of the Federal Register, 800 North Capitol of the wash shows 0.00 absorbance per centi- Street, NW., suite 700, Washington, DC 20408. meter path length between 280 mµ and 400 mµ The accuracy is to be determined by com- when tested as prescribed under ‘‘Organic parison with the standard values at 210, 345, solvents.’’ Usually three portions of wash and 400 millimicrons. solvent are sufficient.

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Before proceeding with analysis of a sam- 250-milliliter separatory funnel and wash in ple, determine the absorbance in a 5-centi- tandem with the 30-milliliter portion of iso- meter path cell between 250 millimicrons and octane contained in the 250-milliliter sepa- 400 millimicrons for the reagent blank by ratory funnels. Shaking time for each wash carrying out the procedure, without a metal is 1 minute. Repeat the extraction operation sample. The absorbance per centimeter path with two additional portions of the sulf- length should not exceed 0.02 in the wave- oxide-acid mixture and wash each extractive length range from 280 mµ to 400 mµ. in tandem through the same three portions Place 300 milliliters of dimethyl sulfoxide of isooctane. in a 1-liter separatory funnel and add 75 mil- Collect the successive extractives (300 milliliters of phosphoric acid. Mix the contents liliters total) in a separatory funnel (pref- of the funnel and allow to stand for 10 min- erably 2-liter) containing 480 milliliters of utes. (The reaction between the sulfoxide distilled water; mix, and allow to cool for a and the acid is exothermic. Release pressure few minutes after the last extractive has after mixing, then keep funnel stoppered.) been added. Add 80 milliliters of isooctane to Add 150 milliliters of isooctane and shake to pre-equilibrate the solvents. Draw off the in- the solution and extract by shaking the fun- dividual layers and store in glass-stoppered nel vigorously for 2 minutes. Draw off the flasks. lower aqueous layer into a second separatory funnel (preferably 2-liter) and repeat the ex- PROCEDURE traction with 80 milliliter of isooctane. Draw off and discard the aqueous layer. Wash each Sample. Select metal foil or sheet stock for of the 80 milliliter extractives three times the test which has not been previously con- with 100-milliliter portions distilled water. taminated by careless handling or exposure Shaking time for each wash is 1 minute. Dis- to atmospheric dust and fumes. A commer- card the aqueous layers. Filter the first ex- cial coil in the form supplied for spindle mounting in a packaging line or wrapping tractive through anhydrous sodium sulfate machine is most suitable. Strip off the out- pre-washed with isooctane (see sodium sul- side turn of metal and discard. Carefully fate under ‘‘Reagents and Materials’’ for avoid contamination or damage from han- preparation of filter) into a 250-milliliter Er- dling the metal (wear gloves). Remove a 16– lenmeyer flask (or optionally into the evapo- 18-foot length from the coil and place it on a ration flask). Wash the first separatory fun- flat surface protected by a length of new nel with the second 80-milliliter isooctane kraft paper. Cut four 15-foot strips from the extractive and pass through the sodium sul- sample, each 3 inches wide (avoid tearing the fate. Then wash the second and first sepa- edges of the strips). Using a piece of suitable ratory funnels successively with a 20-milli- glass rod, roll the strips of metal into loose liter portion of isooctane and pass the sol- coils and insert each into a Soxhlet thimble. vent through the sodium sulfate into the Each turn of coil should be visibly separated flask. Add 1 milliliter of n-hexadecane and from the adjacent turn. evaporate the isooctane on the steam bath Extraction. Fill each of the four Soxhlet under nitrogen. Discontinue evaporation tubes with purified isooctane (see under when not over 1 milliliter of residue remains. heading ‘‘Reagents and Materials,’’ above) To the residue, add a 10-milliliter portion of until siphon action occurs and then refill the isooctane, reevaporate to 1 milliliter of tube body. Supply heat to the boiling flask hexadecane, and repeat this operation once. and allow extraction to continue for at least Quantitatively transfer the residue with 8 hours or until repeated weighings of the isooctane to a 25-milliliter volumetric flask, dried and cooled coil show no further weight make to volume, and mix. Determine the ab- loss. sorbance of the solution in 5-centimeter Combine the isooctane extracts from the pathlength cells compared to isooctane as four Soxhlet units in a suitable beaker, rins- reference between 280mµ–400mµ (take care to ing each tube and flask into the beaker with lose none of the solution in filling the sam- fresh purified solvent. Evaporate the solvent ple cell). Correct the absorbance values for under an atmosphere of inert gas (nitrogen) any absorbance derived from reagents as de- to residual volume of 50–60 milliliters and termined by carrying out the procedure transfer this solution to a 500-milliliter sepa- without a metal sample. If the corrected ab- ratory funnel containing 100 milliliters of sorbance does not exceed the limits pre- pre-equilibrated sulfoxide-phosphoric acid scribed in this paragraph, the residue meets mixture. Complete the transfer of the sample the ultraviolet absorbance specifications. with small portions of pre-equilibrated isooctane to give a total volume of the residue (b) The following substances may be and solvent of 75 milliliters. Shake the fun- used in surface lubricants used to fa- nel vigorously for 2 minutes. Set up three 250-milliliter separatory funnels with each cilitate the drawing, stamping, or containing 30 milliliters of pre-equilibrated forming of metallic articles from rolled isooctane. After separation of liquid phases, foil or sheet stock by further proc- carefully draw off lower layer into the first essing provided that the total residual

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lubricant remaining on the metallic ar- (1) Antioxidants used in compliance ticle in the form in which it contacts with regulations in parts 170 through food does not exceed 0.2 milligram per 189 of this chapter. square inch of food-contact surface: (2) Substances identified in this subparagraph.

List of substances Limitations

Acetyl tributyl citrate. Acetyl triethyl citrate. Butyl stearate. Castor oil. Dibutyl sebacate. Di(2-ethylhexyl) azelate. Di(2-ethylhexyl) sebacate. Diisodecyl phthalate. Dimethylpolysiloxane ...... Conforming to the identity prescribed in § 181.28 of this chapter. Dipropylene glycol. Epoxidized soybean oil ...... Conforming to the identity prescribed in § 181.27 of this chapter. Fatty acids derived from animal and vegetable fats and oils, and salts of such acids, single or mixed, as follows: Aluminum Magnesium Potassium Sodium Zinc Fatty alcohols, straight-chain with even number carbon atoms (C10 or greater). Isobutyl stearate. Lanolin. Linoleic acid amide. Mineral oil ...... Conforming to the identity prescribed in § 178.3620 (a) or (b). Mono-, di-, and tristearyl citrate. Oleic acid amide. Palmitic acid amide. Petrolatum ...... Conforming to the identity prescribed in § 178.3700. Phosphoric acid, mono- and dihexyl esters, compounds with For use only at levels not to exceed 0.5 percent by weight of tetramethylnonylamines and C11–14-alkylamines (CAS Reg. the finished surface lubricant formulation. No. 80939–62–4). Polyethylene glycol (molecular weight 300 or greater) ...... Mono- and diethylene glycol content not to exceed a total of 0.2 pct. Stannous stearate. Stearic acid amide. Stearyl stearate. Tetrakis[methylene (3,5-di-tert-butyl-4-hydroxyhydrocinnamate)] For use at a level not to exceed 0.5 percent by weight of the methane (CAS Registry No. 6683–19–8). finished surface lubricant formulation. Triethylene glycol ...... Diethylene glycol content not to exceed 0.1 pct. Wax, petroleum ...... Complying with § 178.3710.

(c) The substances identified in para- plish the intended technical effect and graph (a)(2) of this section may be used shall not be intended to nor, in fact, in surface lubricants used to facilitate accomplish any technical effect in the the drawing, stamping, and forming of food itself. metallic articles from rolled foil and (e) The use of the surface lubricants sheet stock provided that total resid- in the manufacture of any article that ual lubricant remaining on the metal- is the subject of a regulation in parts lic article in the form in which it con- 174, 175, 176, 177, 178 and § 179.45 of this tacts food does not exceed 0.015 milli- chapter must comply with any speci- gram per square inch of food-contact fications prescribed by such regulation surface. for the finished form of the article. (d) Subject to any prescribed limita- (f) Any substance that is listed in tions, the quantity of surface lubricant this section and the subject of a regula- used in the manufacture of metallic ar- tion in parts 174, 175, 176, 177, 178 and ticles shall not exceed the least § 179.45 of this chapter shall comply amount reasonably required to accom-

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with any applicable specifications pre- erized with one another in any com- scribed by such regulation. bination, or it may be used as a solvent in the casting of film prepared from [42 FR 14609, Mar. 15, 1977, as amended at 48 FR 238, Jan. 4, 1983; 49 FR 10113, Mar. 19, 1984; vinyl chloride copolymers complying 49 FR 29579, July 23, 1984; 50 FR 36874, Sept. with § 177.1980 of this chapter. 10, 1985; 52 FR 10223, Mar. 31, 1987; 54 FR 6124, (b) The residual amount of tetra- Feb. 8, 1989; 54 FR 24899, June 12, 1989; 56 FR hydrofuran in the film does not exceed 55456, Oct. 28, 1991; 57 FR 23953, June 5, 1992; 1.5 percent by weight of film. 58 FR 17513, Apr. 5, 1993; 64 FR 47110, Aug. 30, 1999] PART 179—IRRADIATION IN THE § 178.3930 Terpene resins. PRODUCTION, PROCESSING AND The terpene resins identified in para- HANDLING OF FOOD graph (a) of this section may be safely used as components of polypropylene Subpart A [Reserved] film intended for use in contact with food, and the terpene resins identified Subpart B—Radiation and Radiation in paragraph (b) of this section may be Sources safely used as components of polyolefin Sec. film intended for use in contact with 179.21 Sources of radiation used for inspec- food; tion of food, for inspection of packaged (a) Terpene resins consisting of the food, and for controlling food processing. hydrogenated polymers of terpene hy- 179.25 General provisions for food irradia- drocarbons obtainable from sulfate tur- tion. pentine and meeting the following 179.26 Ionizing radiation for the treatment specifications: Drop-softening point of of food. ° ° 179.30 Radiofrequency radiation for the 118 –138 C; iodine value less than 20. heating of food, including microwave fre- (b) Terpene resins consisting of poly- quencies. mers of beta-pinene and meeting the 179.39 Ultraviolet radiation for the proc- following specifications: Acid value essing and treatment of food. less than 1; saponification number less 179.41 Pulsed light for the treatment of than 1; color less than 4 on the Gardner food. scale as measured in 50 percent mineral spirits solution. Subpart C—Packaging Materials for Irradiated Foods § 178.3940 Tetraethylene glycol di-(2- ethylhexoate). 179.45 Packaging materials for use during the irradiation of prepackaged foods. Tetraethylene glycol di-(2- AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 373, ethylhexoate) containing not more 374. than 22 parts per million ethylene and/ or diethylene glycols may be used at a SOURCE: 42 FR 14635, Mar. 15, 1977, unless level not to exceed 0.7 percent by otherwise noted. weight of twine as a finish on twine to be used for tying meat provided the Subpart A [Reserved] twine fibers are produced from nylon resins complying with § 177.1500 of this Subpart B—Radiation and chapter. Radiation Sources

§ 178.3950 Tetrahydrofuran. § 179.21 Sources of radiation used for Tetrahydrofuran may be safely used inspection of food, for inspection of in the fabrication of articles intended packaged food, and for controlling for packaging, transporting, or storing food processing. foods, subject to the provisions of this Sources of radiation for the purposes section. of inspection of foods, for inspection of (a) It is used as a solvent in the cast- packaged food, and for controlling food ing of film from a solution of poly- processing may be safely used under meric resins of vinyl chloride, vinyl ac- the following conditions: etate, or vinylidene chloride that have (a) The radiation source is one of the been polymerized singly or copolym- following:

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(1) X-ray tubes producing X-radiation the requirements of part 110 of this from operation of the tube source at a chapter and other applicable regula- voltage of 500 kilovolt peak or lower. tions. (2) Sealed units producing radiations (b) Food treated with ionizing radi- at energy levels of not more than 2.2 ation shall receive the minimum radi- million electron volts from one of the ation dose reasonably required to ac- following isotopes: Americium-241, ce- complish its intended technical effect sium-137, cobalt-60, iodine-125, krypton- and not more than the maximum dose 85, radium-226, and strontium-90. specified by the applicable regulation (3) Sealed units producing neutron for that use. radiation from the isotope Califor- (c) Packaging materials subjected to nium-252 (CAS Reg. No. 13981–17–4) to irradiation incidental to the radiation measure moisture in food. treatment and processing of pre- (4) Machine sources producing X-radi- packaged food shall be in compliance ation at energies no greater than 10 with § 179.45, shall be the subject of an million electron volts (MeV). exemption for such use under § 170.39 of (b) To assure safe use of these radi- this chapter, or shall be the subject of ation sources: an effective premarket notification for (1) The label of the sources shall a food contact substance for such use bear, in addition to the other informa- submitted under § 170.100 of this chap- tion required by the Act: ter. (i) Appropriate and accurate informa- (d) Radiation treatment of food shall tion identifying the source of radi- conform to a scheduled process. A ation. scheduled process for food irradiation (ii) The maximum energy of radi- is a written procedure that ensures ation emitted by X-ray tube sources. that the radiation dose range selected (iii) The maximum energy of X-radi- by the food irradiation processor is ation emitted by machine source. adequate under commercial processing (2) The label or accompanying label- conditions (including atmosphere and ing shall bear: temperature) for the radiation to (i) Adequate directions for installa- achieve its intended effect on a specific tion and use. product and in a specific facility. A (ii) A statement that no food shall be food irradiation processor shall operate exposed to radiation sources listed in with a scheduled process established by paragraph (a) (1) and (2) of this section qualified persons having expert knowl- so as to receive an absorbed dose in ex- edge in radiation processing require- cess of 10 grays. ments of food and specific for that food (iii) A statement that no food shall and for that irradiation processor’s be exposed to a radiation source listed treatment facility. in paragraph (a)(3) of this section so as (e) A food irradiation processor shall to receive an absorbed dose in excess of maintain records as specified in this 2 milligrays. section for a period of time that ex- (iv) A statement that no food shall be ceeds the shelf life of the irradiated exposed to a radiation source listed in food product by 1 year, up to a max- paragraph (a)(4) of this section so as to imum of 3 years, whichever period is receive a dose in excess of 0.5 gray shorter, and shall make these records (Gy). available for inspection and copy by authorized employees of the Food and [42 FR 14635, Mar. 15, 1977, as amended at 48 Drug Administration. Such records FR 46022, Oct. 11, 1983; 61 FR 14246, Apr. 1, 1996; 64 FR 69191, Dec. 10, 1999; 66 FR 18539, shall include the food treated, lot iden- Apr. 10, 2001] tification, scheduled process, evidence of compliance with the scheduled proc- § 179.25 General provisions for food ir- ess, ionizing energy source, source cali- radiation. bration, dosimetry, dose distribution in For the purposes of § 179.26, current the product, and the date of irradia- good manufacturing practice is defined tion. to include the following restrictions: [51 FR 13399, Apr. 18, 1986, as amended at 67 (a) Any firm that treats foods with FR 9585, Mar. 4, 2002; 67 FR 35731, May 21, ionizing radiation shall comply with 2002]

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§ 179.26 Ionizing radiation for the Use Limitations treatment of food. 6. For control of food-borne pathogens Not to exceed 3 Ionizing radiation for treatment of in fresh or frozen, uncooked poultry kGy (300 krad); foods may be safely used under the fol- products that are: (1) Whole car- any packaging casses or disjointed portions of such used shall not lowing conditions: carcasses that are ‘‘ready-to-cook exclude oxygen. (a) Energy sources. Ionizing radiation poultry’’ within the meaning of 9 CFR is limited to: 381.1(b)(44), or (2) mechanically sep- (1) Gamma rays from sealed units of arated poultry product (a finely comminuted ingredient produced by the radionuclides cobalt-60 or cesium- the mechanical deboning of poultry 137. carcasses or parts of carcasses). (2) Electrons generated from machine 7. For the sterilization of frozen, pack- Minimum dose 44 sources at energies not to exceed 10 aged meats used solely in the Na- kGy (4.4 Mrad). tional Aeronautics and Space Admin- Packaging mate- million electron volts. istration space flight programs. rials used need (3) X-rays generated from machine not comply with sources at energies not to exceed 5 mil- § 179.25(c) pro- lion electron volts. vided that their use is otherwise (b) Limitations. permitted by applicable regula- Use Limitations tions in parts 174 through 186 of 1. For control of Trichinella spiralis in Minimum dose 0.3 this chapter. pork carcasses or fresh, non-heat- kiloGray (kGy) 8. For control of foodborne pathogens Not to exceed 4.5 processed cuts of pork carcasses. (30 kilorad in, and extension of the shelf-life of, kGy maximum (krad)); maximum refrigerated or frozen, uncooked for refrigerated dose not to ex- products that are meat within the products; not to ceed 1 kGy (100 meaning of 9 CFR 301.2(rr), meat exceed 7.0 kGy krad). 2. For growth and maturation inhibition Not to exceed 1 byproducts within the meaning of 9 maximum for fro- of fresh foods. kGy (100 krad). CFR 301.2(tt), or meat food products zen products. 3. For disinfestation of arthropod pests Do. within the meaning of 9 CFR in food. 301.2(uu), with or without nonfluid 4. For microbial disinfection of dry or Not to exceed 10 seasoning, that are otherwise com- dehydrated enzyme preparations (in- kGy (1 megarad posed solely of intact or ground cluding immobilized enzymes). (Mrad)). meat, meat byproducts, or both meat 5. For microbial disinfection of the fol- Not to exceed 30 and meat byproducts. lowing dry or dehydrated aromatic kGy (3 Mrad). 9. For control of Salmonella in fresh Not to exceed 3.0 vegetable substances when used as shell eggs.. kGy. ingredients in small amounts solely 10. For control of microbial pathogens Not to exceed 8.0 for flavoring or aroma: culinary herbs, on seeds for sprouting.. kGy. seeds, spices, vegetable seasonings that are used to impart flavor but that (c) Labeling. (1) The label and label- are not either represented as, or appear to be, a vegetable that is eaten ing of retail packages of foods irradi- for its own sake, and blends of these ated in conformance with paragraph (b) aromatic vegetable substances. Tur- of this section shall bear the following meric and paprika may also be irradiated when they are to be used as logo along with either the statement color additives. The blends may contain sodium chloride and minor amounts of dry food ingredients ordinarily used in such blends.

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‘‘Treated with radiation’’ or the when shipped to a food manufacturer statement ‘‘Treated by irradiation’’ in or processor for further processing, la- addition to information required by beling, or packing. other regulations. The logo shall be [51 FR 13399, Apr. 18, 1986, as amended at 53 placed prominently and conspicuously FR 12757, Apr. 18, 1988; 53 FR 53209, Dec. 30, in conjunction with the required state- 1988; 54 FR 32335, Aug. 7, 1989; 55 FR 14415, ment. The radiation disclosure state- Apr. 18, 1990; 55 FR 18544, May 2, 1990; 60 FR ment is not required to be more promi- 12670, Mar. 8, 1995; 62 FR 64121, Dec. 3, 1997; 63 nent than the declaration of ingredi- FR 43876, Aug. 17, 1998; 65 FR 45282, July 21, ents required under § 101.4 of this chap- 2000; 65 FR 64607, Oct. 30, 2000] ter. As used in this provision, the term ‘‘radiation disclosure statement’’ § 179.30 Radiofrequency radiation for means the written statement that dis- the heating of food, including microwave frequencies. closes that a food has been inten- tionally subject to irradiation. Radiofrequency radiation, including (2) For irradiated foods not in pack- microwave frequencies, may be safely age form, the required logo and phrase used for heating food under the fol- ‘‘Treated with radiation’’ or ‘‘Treated lowing conditions: by irradiation’’ shall be displayed to (a) The radiation source consists of the purchaser with either (i) the label- electronic equipment producing radio ing of the bulk container plainly in waves with specific frequencies for this view or (ii) a counter sign, card, or purpose authorized by the Federal other appropriate device bearing the Communications Commission. information that the product has been (b) The radiation is used or intended treated with radiation. As an alter- for use in the production of heat in native, each item of food may be indi- food wherever heat is necessary and ef- vidually labeled. In either case, the in- fective in the treatment or processing formation must be prominently and of food. conspicuously displayed to purchasers. The labeling requirement applies only § 179.39 Ultraviolet radiation for the to a food that has been irradiated, not processing and treatment of food. to a food that merely contains an irra- Ultraviolet radiation for the proc- diated ingredient but that has not essing and treatment of food may be itself been irradiated. safely used under the following condi- (3) For a food, any portion of which is tions: irradiated in conformance with para- (a) The radiation sources consist of graph (b) of this section, the label and low pressure mercury lamps emitting labeling and invoices or bills of lading 90 percent of the emission at a wave- shall bear either the statement length of 253.7 nanometers (2,537 ‘‘Treated with radiation—do not irra- Angstroms). diate again’’ or the statement ‘‘Treated (b) The ultraviolet radiation is used by irradiation—do not irradiate again’’ or intended for use as follows:

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Irradiated food Limitations Use

Food and food products ...... Without ozone production: high fat-content food irradiated Surface microorganism con- in vacuum or in an inert atmosphere; intensity of radi- trol. ation, 1 W (of 2,537 A. radiation) per 5 to 10 ft.2. Potable water ...... Without ozone production; coefficient of absorption, 0.19 Sterilization of water used in per cm or less; flow rate, 100 gal/h per watt of 2,537 A. food production. radiation; water depth, 1 cm or less; lamp-operating temperature, 36 to 46 °C.. Juice products ...... Turbulent flow through tubes with a minimum Reynolds Reduction of human patho- number of 2,200.. gens and other microorganisms.

[42 FR 14635, Mar. 15, 1977, as amended at 65 FR 71057, Nov. 29, 2000]

§ 179.41 Pulsed light for the treatment less otherwise indicated, incidental to of food. the use of gamma, electron beam, or X- Pulsed light may be safely used for radiation in the radiation treatment of treatment of foods under the following prepackaged foods: conditions: (1) Nitrocellulose-coated or vinyli- (a) The radiation sources consist of dene chloride copolymer-coated cello- xenon flashlamps designed to emit phane complying with § 177.1200 of this broadband radiation consisting of chapter. wavelengths covering the range of 200 (2) Glassine paper complying with to 1,100 nanometers (nm), and operated § 176.170 of this chapter. so that the pulse duration is no longer (3) Wax-coated paperboard complying than 2 milliseconds (msec); with § 176.170 of this chapter. (b) The treatment is used for surface (4) Polyolefin film prepared from one microorganism control; or more of the basic olefin polymers (c) Foods treated with pulsed light complying with § 177.1520 of this chap- shall receive the minimum treatment ter. The finished film may contain: reasonably required to accomplish the (i) Adjuvant substances used in com- intended technical effect; and pliance with §§ 178.3740 and 181.22 (d) The total cumulative treatment through 181.30 of this chapter, sodium shall not exceed 12.0 Joules/square cen- citrate, sodium lauryl sulfate, poly- timeter (J/cm2.) vinyl chloride, and materials as listed [61 FR 42383, Aug. 15, 1996] in paragraph (d)(2)(i) of this section. (ii) Coatings comprising a vinylidene Subpart C—Packaging Materials chloride copolymer containing a min- for Irradiated Foods imum of 85 percent vinylidene chloride with one or more of the following co- § 179.45 Packaging materials for use monomers: Acrylic acid, acrylonitrile, during the irradiation of pre- itaconic acid, methyl acrylate, and packaged foods. methyl methacrylate. The packaging materials identified (5) Kraft paper prepared from un- in this section may be safely subjected bleached sulfate pulp to which rosin, to irradiation incidental to the radi- complying with § 178.3870 of this chap- ation treatment and processing of pre- ter, and alum may be added. The kraft packaged foods, subject to the provi- paper is used only as a container for sions of this section and to the require- flour and is irradiated with a dose not ment that no induced radioactivity is exceeding 500 grays. detectable in the packaging material (6) Polyethylene terephthalate film itself: prepared from the basic polymer as de- (a) The radiation of the food itself scribed in § 177.1630(e)(4)(i) and (ii) of shall comply with regulations in this this chapter. The finished film may part. contain: (b) The following packaging mate- (i) Adjuvant substances used in com- rials may be subjected to a dose of ra- pliance with §§ 178.3740 and 181.22 diation, not to exceed 10 kilograys, un- through 181.30 of this chapter, sodium

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citrate, sodium lauryl sulfate, poly- the American Society for Testing Ma- vinyl chloride, and materials as listed terials, 1916 Race St., Philadelphia, PA in paragraph (d)(2)(i) of this section. 19103, or may be examined at the Office (ii) Coatings comprising a vinylidene of the Federal Register, 800 North Cap- chloride copolymer containing a min- itol Street, NW., suite 700, Washington, imum of 85 percent vinylidene chloride DC 20408. The finished film may con- with one or more of the following co- tain adjuvant substances used in com- monomers: Acrylic acid, acrylonitrile, pliance with §§ 178.3740 and 181.22 itaconic acid, methyl acrylate, and through 181.30 of this chapter. methyl methacrylate. (10) Nylon 11 conforming to § 177.1500 (iii) Coatings consisting of poly- of this chapter. ethylene conforming to § 177.1520 of this (c) Ethylene-vinyl acetate copoly- chapter. mers complying with § 177.1350 of this (7) Polystyrene film prepared from chapter. The ethylene-vinyl acetate styrene basic polymer. The finished packaging materials may be subjected film may contain adjuvant substances to a dose of radiation, not to exceed 30 used in compliance with §§ 178.3740 and kilogray (3 megarads), incidental to 181.22 through 181.30 of this chapter. the use of gamma, electron beam, or X- (8) Rubber hydrochloride film pre- radiation in the radiation treatment of pared from rubber hydrochloride basic packaged foods. polymer having a chlorine content of (d) The following packaging mate- 30–32 weight percent and having a max- rials may be subjected to a dose of ra- imum extractable fraction of 2 weight diation, not to exceed 60 kilograys inci- percent when extracted with n-hexane dental to the use of gamma, electron at reflux temperature for 2 hours. The beam, or X-radiation in the radiation finished film may contain adjuvant processing of prepackaged foods: substances used in compliance with (1) Vegetable parchments, consisting §§ 178.3740 and 181.22 through 181.30 of of a cellulose material made from this chapter. waterleaf paper (unsized) treated with (9) Vinylidene chloride-vinyl chloride concentrated sulfuric acid, neutralized, copolymer film prepared from vinyli- and thoroughly washed with distilled dene chloride-vinyl chloride basic co- water. polymers containing not less than 70 (2) Films prepared from basic poly- weight percent of vinylidene chloride mers and with or without adjuvants, as and having a viscosity of 0.50–1.50 cen- follows: tipoises as determined by ASTM meth- (i) Polyethylene film prepared from od D729–81, ‘‘Standard Specification for the basic polymer as described in Vinylidene Chloride Molding Com- § 177.1520(a) of this chapter. The fin- pounds,’’ which is incorporated by ref- ished film may contain one or more of erence. Copies may be obtained from the following added substances:

Substances Limitations

Amides of erucic, linoleic, oleic, palmitic, and stearic acid ...... Not to exceed 1 pct by weight of the polymer. BHA as described in § 172.110 of this chapter ...... Do. BHT as described in § 172.115 of this chapter ...... Do. Calcium and sodium propionates ...... Do. Petroleum wax as described in § 178.3710 of this chapter ...... Do. Polypropylene, noncrystalline, as described in § 177.1520(c) of Not to exceed 2 pct by weight of the polymer. this chapter. Stearates of aluminum, calcium, magnesium, potassium, and Not to exceed 1 pct by weight of the polymer. sodium as described in § 172.863(a) of this chapter. Triethylene glycol as described in § 178.3740(b) of this chapter Do. Mineral oil as described in § 178.3620 (a) or (b) of this chapter Do.

(ii) Polyethylene terephthalate film listed in paragraph (d)(2)(i) of this sec- prepared from the basic polymer as de- tion. scribed in § 177.1630(e)(4)(ii) of this (iii) Nylon 6 films prepared from the chapter. The finished film may contain nylon 6 basic polymer as described in one or more of the added substances

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§ 177.1500(a)(6) of this chapter and meet- Subpart A—General Provisions ing the specifications of item 6.1 of the table in § 177.1500(b) of this chapter. § 180.1 General. The finished film may contain one or (a) Substances having a history of more of the added substances listed in use in food for human consumption or paragraph (d)(2)(i) of this section. in food contact surfaces may at any (iv) Vinyl chloride-vinyl acetate co- time have their safety or functionality polymer film prepared from the basic brought into question by new informa- copolymer containing 88.5 to 90.0 tion that in itself is not conclusive. An weight percent of vinyl chloride with interim food additive regulation for 10.0 to 11.5 weight percent of vinyl ace- the use of any such substance may be tate and having a maximum volatility promulgated in this subpart when new of not over 3.0 percent (1 hour at 105 °C) information raises a substantial ques- and viscosity not less than 0.30 deter- tion about the safety or functionality mined by ASTM method D1243–79, of the substance but there is a reason- ‘‘Standard Test Method for Dilute So- able certainty that the substance is lution Viscosity of Vinyl Chloride not harmful and that no harm to the Polymers,’’ Method A, which is incor- public health will result from the con- porated by reference. The availability tinued use of the substance for a lim- of this incorporation by reference is ited period of time while the question given in paragraph (b)(9) of this sec- raised is being resolved by further tion. The finished film may contain study. one or more of the added substances (b) No interim food additive regula- listed in paragraph (d)(2)(i) of this section may be promulgated if the new in- tion. formation is conclusive with respect to (e) Acrylonitrile copolymers identi- the question raised or if there is a rea- fied in this section shall comply with sonable likelihood that the substance the provisions of § 180.22 of this chap- is harmful or that continued use of the ter. substance will result in harm to the public health. [42 FR 14635, Mar. 15, 1977, as amended at 49 (c) The Commissioner, on his own ini- FR 10113, Mar. 19, 1984; 54 FR 7405, Feb. 21, 1989; 54 FR 24899, June 12, 1989; 59 FR 14551, tiative or on the petition of any inter- Mar. 29, 1994; 61 FR 14246, Apr. 1, 1996; 66 FR ested person, pursuant to part 10 of this 10575, Feb. 16, 2001] chapter, may propose an interim food additive regulation. A final order pro- PART 180—FOOD ADDITIVES PER- mulgating an interim food additive regulation shall provide that continued MITTED IN FOOD OR IN CON- use of the substance in food is subject TACT WITH FOOD ON AN IN- to each of the following conditions: TERIM BASIS PENDING ADDI- (1) Use of the substance in food or TIONAL STUDY food contact surfaces must comply with whatever limitations the Commis- Subpart A—General Provisions sioner deems to be appropriate under the circumstances. Sec. (2) Within 60 days following the effec- 180.1 General. tive date of the regulation, an inter- Subpart B—Specific Requirements for ested person shall satisfy the Commis- Certain Food Additives sioner in writing that studies adequate and appropriate to resolve the ques- 180.22 Acrylonitrile copolymers. tions raised about the substance have 180.25 Mannitol. been undertaken, or the Food and Drug 180.30 Brominated vegetable oil. Administration may undertake the 180.37 Saccharin, ammonium saccharin, cal- studies. The Commissioner may extend cium saccharin, and sodium saccharin. this 60-day period if necessary to re- AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371; view and act on proposed protocols. If 42 U.S.C. 241. no such commitment is made, or ade- EDITORIAL NOTE: Nomenclature changes to quate and appropriate studies are not part 180 appear at 61 FR 14482, Apr. 2, 1996, undertaken, an order shall imme- and 66 FR 56035, Nov. 6, 2001. diately be published in the FEDERAL

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REGISTER revoking the interim food ad- (2) The type of studies necessary and ditive regulation effective upon publi- appropriate to resolve questions raised cation. about a substance, (3) A progress report shall be filed on (3) Whether interim results indicate the studies every January 1 and July 1 the reasonable likelihood that a health until completion. If the progress report hazard exists, or is inadequate or if the Commissioner (4) Whether the data available at the concludes that the studies are not conclusion of those studies justify a being pursued promptly and diligently food additive regulation. (f) Where appropriate, an emergency or if interim results indicate a reason- action level may be issued for a sub- able likelihood that a health hazard ex- stance subject to paragraph (a) of this ists, an order will promptly be pub- section that is not an approved food ad- lished in the FEDERAL REGISTER revok- ditive, pending the issuance of a final ing the interim food additive regula- interim food additive regulation. Such tion effective upon publication. an action level shall be issued pursuant (4) If nonclinical laboratory studies to sections 306 and 402(a) of the act to are involved, studies filed with the identify, based upon available data, a Commissioner shall include, with re- safe level of use for the substance. spect to each study, either a statement Such an action level shall be issued in that the study has been or will be con- a notice published in the FEDERAL REG- ducted in compliance with the good ISTER and shall be followed as soon as laboratory practice regulations as set practicable by a proposed interim food forth in part 58 of this chapter, or, if additive regulation. Where the avail- any such study was not conducted in able data do not permit establishing an compliance with such regulations, a action level for the safe use of a sub- brief statement of the reason for the stance, use of the substance may be noncompliance. prohibited. The identification of a pro- (5) [Reserved] hibited substance may be made in part 189 of this chapter when appropriate. (6) If clinical investigations involving human subjects are involved, such in- [42 FR 14636, Mar. 15, 1977, as amended at 42 vestigations filed with the Commis- FR 15674, Mar. 22, 1977; 42 FR 52821, Sept. 30, sioner shall include, with respect to 1977; 46 FR 8952, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981; 50 FR 7492, Feb. 22, 1985; 54 FR each investigation, a statement that 39634, Sept. 27, 1989] the investigation either was conducted in compliance with the requirements for institutional review set forth in Subpart B—Specific Requirements part 56 of this chapter, or was not sub- for Certain Food Additives ject to such requirements in accord- § 180.22 Acrylonitrile copolymers. ance with §§ 56.104 or 56.105, and that it has been or will be conducted in com- Acrylonitrile copolymers may be pliance with the requirements for in- safely used on an interim basis as articles or components of articles intended formed consent set forth in part 50 of for use in contact with food, in accord- this chapter. ance with the following prescribed con- (d) Promptly upon completion of the ditions: studies undertaken on the substance, (a) Limitations for acrylonitrile the Commissioner will review all avail- monomer extraction for finished food- able data, will terminate the interim contact articles, determined by a food additive regulation, and will ei- method of analysis titled ‘‘Gas-Solid ther issue a food additive regulation or Chromatographic Procedure for Deter- will require elimination of the sub- mining Acrylonitrile Monomer in Ac- stance from the food supply. rylonitrile-Containing Polymers and (e) The Commissioner may consult Food Simulating Solvents,’’ which is with advisory committees, professional incorporated by reference. Copies are organizations, or other experts in the available from the Center for Food field, in evaluating: Safety and Applied Nutrition (HFS– (1) Whether an interim food additive 200), Food and Drug Administration, regulation is justified, 5100 Paint Branch Pkwy., College Park,

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MD 20740, or available for inspection at for Food Safety and Applied Nutrition the Office of the Federal Register, 800 (HFS–200), Food and Drug Administra- North Capitol Street, NW., suite 700, tion, 5100 Paint Branch Pkwy., College Washington, DC 20408, are as follows: Park, MD 20740, unless an extension is (1) In the case of single-use articles granted by the Food and Drug Admin- having a volume to surface ratio of 10 istration for good cause shown. Analyt- milliliters or more per square inch of ical methods for the determination of food contact surface—0.003 milligram/ acrylonitrile complexes with n- square inch when extracted to equi- dodecyl-mercaptan, n-octyl mercaptan, librium at 120 °F with food-simulating and 2-mercaptoethanol, titled ‘‘Deter- solvents appropriate to the intended mination of b-Dodecyl- conditions of use. mercaptopropionitrile in NR–16R Aque- (2) In the case of single-use articles ous Extracts’’ and ‘‘Measurement of b- having a volume to surface ratio of less (2-Hdroxyethylmercapto) Propionitrile than 10 milliliters per square inch of in Heptane Food-Simulating Solvent,’’ food contact surface—0.3 part per mil- are incorporated by reference. Copies lion calculated on the basis of the vol- are available from the Center for Food ume of the container when extracted to Safety and Applied Nutrition (HFS– ° equilibrium at 120 F with food-simu- 200), Food and Drug Administration, lating solvents appropriate to the in- 5100 Paint Branch Pkwy., College Park, tended conditions of use. MD 20740, or available for inspection at (3) In the case of repeated-use arti- the Office of the Federal Register, 800 cles—0.003 milligram/square inch when North Capitol Street, NW., suite 700, extracted at a time equivalent to ini- Washington, DC 20408. tial batch usage utilizing food-simu- (c) The following data shall be pro- lating solvents and temperatures ap- vided for finished food-contact articles propriate to the intended conditions of intended for repeated use: use. (1) Qualitative and quantitative mi- The food-simulating solvents shall in- gration values at a time equivalent to clude, where applicable, distilled initial batch usage, utilizing solvents water, 8 percent or 50 percent ethanol, and temperatures appropriate to the 3 percent acetic acid, and either n- intended conditions of use. heptane or an appropriate oil or fat. (b) Where necessary, current regula- (2) Qualitative and quantitative mi- tions permitting the use of acrylo- gration values at the time of equi- nitrile copolymers shall be revised to librium extractions, utilizing solvents specify limitations on acrylonitrile/ and temperatures appropriate to the mercaptan complexes utilized in the intended conditions of use. production of acrylonitrile copolymers. (3) Data on the volume and/or weight Such copolymers, if they contain re- of food handled during the initial batch versible acrylonitrile/mercaptan com- time period(s), during the equilibrium plexes and are used in other than re- test period, and over the estimated life peated-use conditions, shall be tested of the food-contact surface. to determine the identity of the com- (d) Where acrylonitrile copolymers plex and the level of the complex represent only a minor component of a present in the food-contact article. polymer system, calculations based on Such testing shall include determina- 100 percent migration of the acrylo- tion of the rate of decomposition of the nitrile component may be submitted in complex at temperatures of 100 °F, 160 lieu of the requirements of paragraphs °F, and 212 °F using 3 percent acetic (a), (b), and (c) of this section in sup- acid as the hydrolic agent. Acrylo- port of the continued safe use of acry- nitrile monomer levels, acrylonitrile/ lonitrile copolymers. mercaptan complex levels, acrylo- (e) On or before September 13, 1976, nitrile oligomer levels, descriptions of any interested person shall satisfy the the analytical methods used to deter- Commissioner of Food and Drugs that mine the complex and the acrylonitrile toxicological feeding studies adequate migration, and validation studies of and appropriate to establish safe condi- these analytical methods shall be sub- tions for the use of acrylonitrile co- mitted by June 9, 1977, to the Center polymers have been, or soon will be,

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undertaken. Toxicity studies of acrylo- Administration for good cause shown. nitrile monomer shall include: (1) Life- Any application for extension shall be time feeding studies with a mamma- by petition submitted in accordance lian species, preferably with animals with the requirements of part 10 of this exposed in utero to the chemical, (2) chapter. If a petition is denied, in studies of multigeneration reproduc- whole or in part, those uses subject to tion with oral administration of the the denial are thereafter unapproved test material, (3) assessment of food additives and consequently unlaw- teratogenic and mutagenic potentials, ful. (4) subchronic oral administration in a (3) Any use of acrylonitrile copoly- nonrodent mammal, (5) tests to deter- mers subject to paragraph (f)(1) of this mine any synergistic toxic effects be- section shall meet the acrylonitrile tween acrylonitrile monomer and cya- monomer extraction limitation set nide ion, and (6) a literature search on forth in paragraph (a) of this section the effects of chronic ingestion of hy- and shall be subject to the require- drogen cyanide. Data on levels of acryl- ments of paragraph (b) of this section. amide extractable from acrylonitrile (g) In addition to the requirements of copolymers shall also be submitted. this section, the use of acrylonitrile co- Protocols of testing should be sub- polymers shall comply with all applica- mitted for review to the Center for ble requirements in other regulations Food Safety and Applied Nutrition in this part. (HFS–200, Food and Drug Administra- [42 FR 14636, Mar. 15, 1977, as amended at 47 tion, 5100 Paint Branch Pkwy., College FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, Park, MD 20740. 1989; 61 FR 14246, Apr. 1, 1996] (f) Acrylonitrile copolymers may be used in contact with food only if au- § 180.25 Mannitol. thorized in parts 174 through 179 or (a) Mannitol is the chemical § 181.32 of this chapter, except that 1,2,3,4,5,6,-hexanehexol (C6H14O6) a other uses of acrylonitrile copolymers hexahydric alcohol, differing from sor- in use prior to June 14, 1976, may con- bitol principally by having a different tinue under the following conditions: optical rotation. Mannitol is produced (1) On or before August 13, 1976, each by one of the following processes: use of acrylonitrile copolymers in a (1) The electrolytic reduction or manner not authorized by § 181.32 of transition metal catalytic hydro- this chapter or parts 174 through 179 of genation of sugar solutions containing this chapter shall be the subject of a glucose or fructose. notice to the Center for Food Safety (2) The fermentation of sugars or and Applied Nutrition (HFS–200), Food sugar alcohols such as glucose, sucrose, and Drug Administration, 5100 Paint fructose, or sorbitol using the yeast Branch Pkwy., College Park, MD 20740. Zygosaccharomyces rouxii. Such notice shall be accompanied by a (b) The ingredient meets the speci- statement of the basis, including any fications of the ‘‘Food Chemicals articles and correspondence, on which Codex,’’ 3d Ed. (1981), pp. 188–190, which the user in good faith believed the use is incorporated by reference. Copies to be prior-sanctioned. The Commis- may be obtained from the National sioner of Food and Drugs shall, by no- Academy Press, 2101 Constitution Ave. tice in the FEDERAL REGISTER, identify NW., Washington, DC 20418, or may be any use of acrylonitrile copolymers not examined at the Office of the Federal in accordance with this paragraph. Register, 800 North Capitol Street, Those uses are thereafter unapproved NW., suite 700, Washington, DC 20408. food additives and consequently unlaw- (c) The ingredient is used as an ful. anticaking agent and free-flow agent as (2) Any use of acrylonitrile copoly- defined in § 170.3(o)(1) of this chapter, mers subject to paragraph (f)(1) of this formulation aid as defined in § 170.3(o) section shall be the subject of a peti- (14) of this chapter, firming agent as tion submitted on or before December defined in § 170.3(o)(10) of this chapter, 13, 1976, in accordance with § 171.1 of flavoring agent and adjuvant as defined this chapter, unless an extension of in § 170.3(o)(12) of this chapter, lubri- time is granted by the Food and Drug cant and release agent as defined in

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§ 170.3(o)(18) of this chapter, nutritive Academy Press, 2101 Constitution Ave. sweetener as defined in § 170.3(o)(21) of NW., Washington, DC 20418, or may be this chapter, processing aid as defined examined at the Office of the Federal in § 170.3(o)(24) of this chapter, sta- Register, 800 North Capitol Street, bilizer and thickener as defined in NW., suite 700, Washington, DC 20418. § 170.3(o)(28) of this chapter, surface-fin- (b) The additive is used on an interim ishing agent as defined in § 170.3(o)(30) basis as a stabilizer for flavoring oils of this chapter, and texturizer as de- used in fruit-flavored beverages, for fined in § 170.3(o)(32) of this chapter. which any applicable standards of iden- (d) The ingredient is used in food at tity do not preclude such use, in an levels not to exceed 98 percent in amount not to exceed 15 parts per mil- pressed mints and 5 percent in all other lion in the finished beverage, pending hard candy and cough drops as defined the outcome of additional toxicological in § 170.3(n)(25) of this chapter, 31 per- studies on which periodic reports at 6- cent in chewing gum as defined in month intervals are to be furnished § 170.3(n)(6) of this chapter, 40 percent and final results submitted to the Food in soft candy as defined in § 170.3(n)(38) and Drug Administration promptly of this chapter, 8 percent in confections after completion of the studies. and frostings as defined in § 170.3(n)(9) of this chapter, 15 percent in non- [42 FR 14636, Mar. 15, 1977, as amended at 49 standardized jams and jellies, commer- FR 5610, Feb. 14, 1984] cial, as defined in § 170.3(n)(28) of this chapter, and at levels less than 2.5 per- § 180.37 Saccharin, ammonium sac- cent in all other foods. charin, calcium saccharin, and so- (e) The label and labeling of food dium saccharin. whose reasonably foreseeable consump- The food additives saccharin, ammo- tion may result in a daily ingestion of nium saccharin, calcium saccharin, and 20 grams of mannitol shall bear the sodium saccharin may be safely used as statement ‘‘Excess consumption may sweetening agents in food in accord- have a laxative effect’’. ance with the following conditions, if (f) In accordance with § 180.1, ade- the substitution for nutritive sweet- quate and appropriate feeding studies eners is for a valid special dietary pur- have been undertaken for this sub- pose and is in accord with current spe- stance. Continued uses of this ingre- cial dietary food regulations and poli- dient are contingent upon timely and cies or if the use or intended use is for adequate progress reports of such tests, an authorized technological purpose and no indication of increased risk to other than calorie reduction: public health during the test period. (a) Saccharin is the chemical, 1,2- (g) Prior sanctions for this ingredient benzisothiazolin-3-one - 1,1 - dioxide different from the uses established in (C7H5NO3S). The named salts of sac- this regulation do not exist or have charin are produced by the additional been waived. neutralization of saccharin with the [42 FR 14636, Mar. 15, 1977, as amended at 49 proper base to yield the desired salt. FR 5610, Feb. 14, 1984; 61 FR 7991, Mar. 1, 1996] (b) The food additives meet the specifications of the ‘‘Food Chemicals § 180.30 Brominated vegetable oil. Codex,’’ 3d Ed. (1981), pp. 22, 62, 266–267, The food additive brominated vege- 297–299, which is incorporated by ref- table oil may be safely used in accord- erence. Copies may be obtained from ance with the following prescribed con- the National Academy Press, 2101 Con- ditions: stitution Ave. NW., Washington, DC (a) The additive complies with speci- 20418, or may be examined at the Office fications prescribed in the ‘‘Food of the Federal Register, 800 North Cap- Chemicals Codex,’’ 3d Ed. (1981), pp. 40– itol Street, NW., suite 700, Washington, 41, which is incorporated by reference, DC 20408. except that free fatty acids (as oleic) (c) Authority for such use shall ex- shall not exceed 2.5 percent and iodine pire when the Commissioner receives value shall not exceed 16. Copies of the the final reports on the ongoing studies material incorporated by reference in Canada and publishes an order on may be obtained from the National the safety of saccharin and its salts

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based on those reports and other avail- shall be that quantity of the food con- able data. taining 30 milligrams or less of the ad- (d) The additives are used or intended ditive. for use as a sweetening agent only in (iii) When the additive is used for cal- special dietary foods, as follows: orie reduction, such other labeling as is (1) In beverages, fruit juice drinks, required by part 105 or § 100.130 of this and bases or mixes when prepared for chapter. consumption in accordance with direc- [42 FR 14636, Mar. 15, 1977, as amended at 49 tions, in amounts not to exceed 12 mil- FR 5610, Feb. 14, 1984] ligrams of the additive, calculated as saccharin, per fluid ounce. (2) As a sugar substitute for cooking PART 181—PRIOR-SANCTIONED or table use, in amounts not to exceed FOOD INGREDIENTS 20 milligrams of the additive, calculated as saccharin, for each ex- Subpart A—General Provisions pressed teaspoonful of sugar sweet- Sec. ening equivalency. 181.1 General. (3) In processed foods, in amounts not 181.5 Prior sanctions. to exceed 30 milligrams of the additive, calculated as saccharin, per serving of Subpart B—Specific Prior-Sanctioned Food designated size. Ingredients (e) The additives are used or intended for use only for the following techno- 181.22 Certain substances employed in the manufacture of food-packaging mate- logical purposes: rials. (1) To reduce bulk and enhance fla- 181.23 Antimycotics. vors in chewable vitamin tablets, 181.24 Antioxidants. chewable mineral tablets, or combina- 181.25 Driers. tions thereof. 181.26 Drying oils as components of finished (2) To retain flavor and physical resins. properties of chewing gum. 181.27 Plasticizers. (3) To enhance flavor of flavor chips 181.28 Release agents. used in nonstandardized bakery prod- 181.29 Stabilizers. 181.30 Substances used in the manufacture ucts. of paper and paperboard products used in (f) To assure safe use of the additives, food packaging. in addition to the other information re- 181.32 Acrylonitrile copolymers and resins. quired by the Act: 181.33 Sodium nitrate and potassium ni- (1) The label of the additive and any trate. intermediate mixes of the additive for 181.34 Sodium nitrite and potassium nitrite. manufacturing purposes shall bear: AUTHORITY: 21 U.S.C. 321, 342, 348, 371. (i) The name of the additive. (ii) A statement of the concentration SOURCE: 42 FR 14638, Mar. 15, 1977, unless otherwise noted. of the additive, expressed as saccharin, in any intermediate mix. EDITORIAL NOTE: Nomenclature changes to (iii) Adequate directions for use to part 181 appear at 61 FR 14482, Apr. 2, 1996, provide a final food product that com- and 66 FR 56035, Nov. 6, 2001. plies with the limitations prescribed in paragraphs (d) and (e) of this section. Subpart A—General Provisions (2) The label of any finished food product containing the additive shall § 181.1 General. bear: (a) An ingredient whose use in food (i) The name of the additive. or food packaging is subject to a prior (ii) The amount of the additive, cal- sanction or approval within the mean- culated as saccharin, as follows: ing of section 201(s)(4) of the Act is ex- (a) For beverages, in milligrams per empt from classification as a food addi- fluid ounce; tive. The Commissioner will publish in (b) For cooking or table use products, this part all known prior sanctions. in milligrams per dispensing unit; Any interested person may submit to (c) For processed foods, in terms of the Commissioner a request for publi- the weight or size of a serving which cation of a prior sanction, supported by

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evidence to show that it falls within dient, or revocation to prohibit use of section 201(s)(4) of the Act. the ingredient, in order to prevent the (b) Based upon scientific data or in- adulteration of food in violation of sec- formation that shows that use of a tion 402 of the Act. prior-sanctioned food ingredient may (d) In proposing, after a general eval- be injurious to health, and thus in vio- uation of use of an ingredient, regula- lation of section 402 of the Act, the tions affirming the GRAS status of Commissioner will establish or amend substances added directly to human an applicable prior sanction regulation food in part 184 of this chapter or sub- to impose whatever limitations or con- stances in food-contact surfaces in part ditions are necessary for the safe use of 186 of this chapter, or establishing a the ingredient, or to prohibit use of the food additive regulation for substances ingredient. added directly to human food in parts (c) Where appropriate, an emergency 172 and 173 of this chapter or food addi- action level may be issued for a prior- tives in food-contact surfaces in parts sanctioned substance, pending the 174, 175, 176, 177, 178 and § 179.45 of this issuance of a final regulation in ac- chapter, the Commissioner shall, if he cordance with paragraph (b) of this sec- is aware of any prior sanction for use tion. Such an action level shall be of the ingredient under conditions dif- issued pursuant to section 402(a) of the ferent from those proposed in the regu- Act to identify, based upon available lation, concurrently propose a separate data, conditions of use of the substance regulation covering such use of the in- that may be injurious to health. Such gredient under this part. If the Com- an action level shall be issued in a no- missioner is unaware of any such appli- tice published in the FEDERAL REG- cable prior sanction, the proposed regu- ISTER and shall be followed as soon as lation will so state and will require any practicable by a proposed regulation in person who intends to assert or rely on accordance with paragraph (b) of this such sanction to submit proof of its ex- section. Where the available data dem- istence. Any food additive or GRAS onstrate that the substance may be in- regulation promulgated after a general jurious at any level, use of the sub- evaluation of use of an ingredient con- stance may be prohibited. The identi- stitutes a determination that excluded fication of a prohibited substance may uses would result in adulteration of the be made in part 189 of this chapter food in violation of section 402 of the when appropriate. Act, and the failure of any person to [42 FR 14638, Mar. 15, 1977, as amended at 42 come forward with proof of such an ap- FR 52821, Sept. 30, 1977; 54 FR 39635, Sept. 27, plicable prior sanction in response to a 1989] proposal will constitute a waiver of the right to assert or rely on such sanction § 181.5 Prior sanctions. at any later time. The notice will also (a) A prior sanction shall exist only constitute a proposal to establish a for a specific use(s) of a substance in regulation under this part, incor- food, i.e., the level(s), condition(s), porating the same provisions, in the product(s), etc., for which there was ex- event that such a regulation is deter- plicit approval by the Food and Drug mined to be appropriate as a result of Administration or the United States submission of proof of such an applica- Department of Agriculture prior to ble prior sanction in response to the September 6, 1958. proposal. (b) The existence of a prior sanction exempts the sanctioned use(s) from the Subpart B—Specific Prior- food additive provisions of the Act but Sanctioned Food Ingredients not from the other adulteration or the misbranding provisions of the Act. § 181.22 Certain substances employed (c) All known prior sanctions shall be in the manufacture of food-pack- the subject of a regulation published in aging materials. this part. Any such regulation is sub- Prior to the enactment of the food ject to amendment to impose whatever additives amendment to the Federal limitation(s) or condition(s) may be Food, Drug, and Cosmetic Act, sanc- necessary for the safe use of the ingre- tions were granted for the usage of the

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substances listed in §§ 181.23, 181.24, Cobalt caprylate. 181.25, 181.26, 181.27, 181.28, 181.29, and Cobalt linoleate. 181.30 in the manufacture of packaging Cobalt naphthenate. materials. So used, these substances Cobalt tallate. are not considered ‘‘food additives’’ Iron caprylate. within the meaning of section 201(s) of Iron linoleate. the Act, provided that they are of good Iron naphthenate. commercial grade, are suitable for as- Iron tallate. sociation with food, and are used in ac- Manganese caprylate. cordance with good manufacturing Manganese linoleate. practice. For the purpose of this sub- Manganese naphthenate. part, good manufacturing practice for Manganese tallate. food-packaging materials includes the [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. restriction that the quantity of any of 28, 1977] these substances which becomes a component of food as a result of use in § 181.26 Drying oils as components of food-packaging materials shall not be finished resins. intended to accomplish any physical or Substances classified as drying oils, technical effect in the food itself, shall when migrating from food-packaging be reduced to the least amount reason- material (as components of finished ably possible, and shall not exceed any resins) shall include: limit specified in this subpart. Chinawood oil (tung oil). [42 FR 56728, Oct. 28, 1977] Dehydrated castor oil. Linseed oil. § 181.23 Antimycotics. Tall oil. Substances classified as [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. antimycotics, when migrating from 28, 1977] food-packaging material shall include: Calcium propionate. § 181.27 Plasticizers. Methylparaben (methyl p-hydroxybenzoate). Substances classified as plasticizers, Propylparaben (propyl p-hydroxybenzoate). when migrating from food-packaging Sodium benzoate. material shall include: Sodium propionate. Sorbic acid. Acetyl tributyl citrate. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. Acetyl triethyl citrate. 28, 1977] p-tert-Butylphenyl salicylate. Butyl stearate. § 181.24 Antioxidants. Butylphthalyl butyl glycolate. Substances classified as antioxidants, Dibutyl sebacate. when migrating from food-packaging Di-(2-ethylhexyl) phthalate (for foods of high water content only). material (limit of addition to food, Diethyl phthalate. 0.005 percent) shall include: Diisobutyl adipate. Butylated hydroxyanisole. Diisooctyl phthalate (for foods of high water Butylated hydroxytoluene. content only). Dilauryl thiodipropionate. Diphenyl-2-ethylhexyl phosphate. Distearyl thiodipropionate. Epoxidized soybean oil (iodine number max- Gum guaiac. imum 6; and oxirane oxygen, minimum, 6.0 Nordihydroguairetic acid. percent). Propyl gallate. Ethylphthalyl ethyl glycolate. Thiodipropionic acid. Glycerol monooleate. 2,4,5-Trihydroxy butyrophenone. Monoisopropyl citrate. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. Mono, di-, and tristearyl citrate. 28, 1977] Triacetin (glycerol triacetate). Triethyl citrate. § 181.25 Driers. 3-(2-Xenolyl)-1,2-epoxypropane. Substances classified as driers, when [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. migrating from food-packaging mate- 28, 1977, as amended at 50 FR 49536, Dec. 3, rial shall include: 1985]

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§ 181.28 Release agents. Aliphatic polyoxyethylene ethers.* 1-Alkyl (C6-C18)3-amino-3-aminopropane Substances classified as release monoacetate.* agents, when migrating from food- Borax or boric acid for use in adhesives, packaging material shall include: sizes, and coatings.* Butadiene-styrene copolymer. Dimethylpolysiloxane (substantially free Chromium complex of perfluoro-octane from hydrolyzable chloride and alkoxy sulfonyl glycine for use on paper and pa- groups, no more than 18 percent loss in perboard which is waxed.* weight after heating 4 hours at 200 °C.; vis- Disodium cyanodithioimidocarbamate with cosity 300 centisokes, 600 centisokes at 25 ethylene diamine and potassium N-methyl °C, specific gravity 0.96 to 0.97 at 25 °C, re- dithiocarbamate and/or sodium 2- fractive index 1.400 to 1.404 at 25 °C). mercaptobenzothiazole (slimicides).* Linoleamide (linoleic acid amide). Ethyl acrylate and methyl methacrylate co- Oleamide (oleic acid amide). polymers of itaconic acid or methacrylic Palmitamide (palmitic acid amide). acid for use only on paper and paperboard Stearamide (stearic acid amide). which is waxed.* Hexamethylene tetramine as a setting agent [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. for protein, including casein.* 28, 1977] 1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2-alkyl (C6-C17) imidazolinium chloride.* § 181.29 Stabilizers. Itaconic acid (polymerized). Substances classified as stabilizers, Melamine formaldehyde polymer. when migrating from food-packaging Methyl acrylate (polymerized). material shall include: Methyl ethers of mono-, di-, and tripropylene glycol.* Aluminum mono-, di-, and tristearate. Myristo chromic chloride complex. Ammonium citrate. Nitrocellulose. Ammonium potassium hydrogen phosphate. Polyethylene glycol 400. Calcium glycerophosphate. Polyvinyl acetate. Calcium phosphate. Potassium pentachlorophenate as a slime Calcium hydrogen phosphate. control agent.* Calcium oleate. Potassium trichlorophenate as a slime con- Calcium acetate. trol agent.* Calcium carbonate. Resins from high and low viscosity polyvinyl Calcium ricinoleate. alcohol for fatty foods only. Calcium stearate. Rubber hydrochloride. Sodium pentachlorophenate as a slime con- Disodium hydrogen phosphate. trol agent.* Magnesium glycerophosphate. Sodium-trichlorophenate as a slime control Magnesium stearate. agent.* Magnesium phosphate. Stearato-chromic chloride complex. Magnesium hydrogen phosphate. Titanium dioxide.* Mono-, di-, and trisodium citrate. Urea formaldehyde polymer. Mono-, di-, and tripotassium citrate. Vinylidine chlorides (polymerized). Potassium oleate. Potassium stearate. § 181.32 Acrylonitrile copolymers and Sodium pyrophosphate. resins. Sodium stearate. Sodium tetrapyrophosphate. (a) Acrylonitrile copolymers and res- Stannous stearate (not to exceed 50 parts per ins listed in this section, containing million tin as a migrant in finished food). less than 30 percent acrylonitrile and Zinc orthophosphate (not to exceed 50 parts complying with the requirements of per million zinc as a migrant in finished paragraph (b) of this section, may be food). safely used as follows: Zinc resinate (not to exceed 50 parts per mil- (1) Films. (i) Acrylonitrile/butadiene/ lion zinc as a migrant in finished food). styrene copolymers—no restrictions. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. (ii) Acrylonitrile/butadiene copoly- 28, 1977] mers—no restrictions. (iii) Acrylonitrile/butadiene copoly- § 181.30 Substances used in the manufacture of paper and paperboard mer blended with vinyl chloride-vinyl products used in food packaging. Substances used in the manufacture *Under the conditions of normal use, these substances would not reasonably be expected of paper and paperboard products used to migrate to food, based on available sci- in food packaging shall include: entific information and data.

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acetate (optional at level up to 5 per- than 10 milliliters per square inch of cent by weight of the vinyl chloride food-contact surface—0.3 part per mil- resin) resin—for use only in contact lion calculated on the basis of the vol- with oleomargarine. ume of the container when extracted to (iv) Acrylonitrile/styrene copoly- equilibrium at 120 °F with food-simu- mer—no restrictions. lating solvents appropriate to the in- (2) Coatings. (i) Acrylonitrile/buta- tended conditions of use. diene copolymer blended with poly- (3) In the case of repeated-use arti- vinyl chloride resins—for use only on cles—0.003 milligram/square inch when paper and paperboard in contact with extracted at a time equivalent to ini- meats and lard. tial batch usage utilizing food-simu- (ii) Polyvinyl chloride resin blended lating solvents and temperatures ap- with either acrylonitrile/butadiene copolymer or acrylonitrile/butadiene sty- propriate to the intended conditions of rene copolymer mixed with neoprene, use. for use as components of conveyor The food-simulating solvents shall in- belts to be used with fresh fruits, vege- clude, where applicable, distilled tables, and fish. water, 8 percent or 50 percent ethanol, (iii) Acrylonitrile/butadiene/styrene 3 percent acetic acid, and either n- copolymer—no restrictions. heptane or an appropriate oil or fat. (iv) Acrylonitrile/styrene copoly- (c) Acrylonitrile monomer may mer—no restrictions. present a hazard to health when in- (3) Rigid and semirigid containers. (i) gested. Accordingly, any food-contact Acrylonitrile/butadiene/styrene copoly- article containing acrylonitrile copolymer—for use only as piping for han- mers or resins that yield acrylonitrile dling food products and for repeated- monomer in excess of that amount pro- use articles intended to contact food. vided for in paragraph (b) of this sec- (ii) Acrylonitrile/styrene resin—no tion shall be deemed to be adulterated restrictions. in violation of section 402 of the Act. (iii) Acrylonitrile/butadiene copolymer blended with polyvinyl chloride [42 FR 14638, Mar. 15, 1977, as amended at 47 resin—for use only as extruded pipe. FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, (b) Limitations for acrylonitrile 1989] monomer extraction for finished food- contact articles, determined by using § 181.33 Sodium nitrate and potassium the method of analysis titled ‘‘Gas- nitrate. Solid Chromatographic Procedure for Sodium nitrate and potassium ni- Determining Acrylonitrile Monomer in trate are subject to prior sanctions Acrylonitrile-Containing Polymers and issued by the U.S. Department of Agri- Food-Simulating Solvents,’’ which is culture for use as sources of nitrite, incorporated by reference. Copies are with or without sodium or potassium available from the Center for Food nitrite, in the production of cured red Safety and Applied Nutrition (HFS– meat products and cured poultry prod- 200), Food and Drug Administration, ucts. 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at [48 FR 1705, Jan. 14, 1983] the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, § 181.34 Sodium nitrite and potassium Washington, DC 20408, are as follows: nitrite. (1) In the case of single-use articles Sodium nitrite and potassium nitrite having a volume to surface ratio of 10 are subject to prior sanctions issued by milliliters or more per square inch of the U.S. Department of Agriculture for food-contact surface—0.003 milligram/ use as color fixatives and preservative square inch when extracted to equi- agents, with or without sodium or po- librium at 120 °F with food-simulating tassium nitrate, in the curing of red solvents appropriate to the intended meat and poultry products. conditions of use. (2) In the case of single-use articles [48 FR 1705, Jan. 14, 1983] having a volume to surface ratio of less

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PART 182—SUBSTANCES 182.3041 Erythorbic acid. 182.3089 Sorbic acid. GENERALLY RECOGNIZED AS SAFE 182.3109 Thiodipropionic acid. 182.3149 Ascorbyl palmitate. Subpart A—General Provisions 182.3169 Butylated hydroxyanisole. Sec. 182.3173 Butylated hydroxytoluene. 182.1 Substances that are generally recog- 182.3189 Calcium ascorbate. nized as safe. 182.3225 Calcium sorbate. 182.10 Spices and other natural seasonings 182.3280 Dilauryl thiodipropionate. and flavorings. 182.3616 Potassium bisulfite. 182.20 Essential oils, oleoresins (solvent- 182.3637 Potassium metabisulfite. free), and natural extractives (including 182.3640 Potassium sorbate. distillates). 182.3731 Sodium ascorbate. 182.40 Natural extractives (solvent-free) 182.3739 Sodium bisulfite. used in conjunction with spices, 182.3766 Sodium metabisulfite. seasonings, and flavorings. 182.3795 Sodium sorbate. 182.50 Certain other spices, seasonings, es- 182.3798 Sodium sulfite. sential oils, oleoresins, and natural ex- 182.3862 Sulfur dioxide. tracts. 182.3890 Tocopherols. 182.60 Synthetic flavoring substances and adjuvants. Subpart E—Emulsifying Agents [Reserved] 182.70 Substances migrating from cotton and cotton fabrics used in dry food pack- Subpart F—Dietary Supplements aging. [Reserved] 182.90 Substances migrating to food from paper and paperboard products. 182.99 Adjuvants for pesticide chemicals. Subpart G—Sequestrants 182.6085 Sodium acid phosphate. Subpart B—Multiple Purpose GRAS Food 182.6197 Calcium diacetate. Substances 182.6203 Calcium hexametaphosphate. 182.1045 Glutamic acid. 182.6215 Monobasic calcium phosphate. 182.1047 Glutamic acid hydrochloride. 182.6285 Dipotassium phosphate. 182.1057 Hydrochloric acid. 182.6290 Disodium phosphate. 182.1073 Phosphoric acid. 182.6757 Sodium gluconate. 182.1087 Sodium acid pyrophosphate. 182.6760 Sodium hexametaphosphate. 182.1125 Aluminum sulfate. 182.6769 Sodium metaphosphate. 182.1127 Aluminum ammonium sulfate. 182.6778 Sodium phosphate. 182.1129 Aluminum potassium sulfate. 182.6787 Sodium pyrophosphate. 182.1131 Aluminum sodium sulfate. 182.6789 Tetra sodium pyrophosphate. 182.1180 Caffeine. 182.6810 Sodium tripolyphosphate. 182.1217 Calcium phosphate. 182.1235 Caramel. Subpart H—Stabilizers 182.1320 Glycerin. 182.1480 Methylcellulose. 182.7255 Chondrus extract. 182.1500 Monoammonium glutamate. 182.1516 Monopotassium glutamate. Subpart I—Nutrients 182.1711 Silica aerogel. 182.1745 Sodium carboxymethylcellulose. 182.8013 Ascorbic acid. 182.1748 Sodium caseinate. 182.8159 Biotin. 182.1778 Sodium phosphate. 182.8217 Calcium phosphate. 182.1781 Sodium aluminum phosphate. 182.8223 Calcium pyrophosphate. 182.1810 Sodium tripolyphosphate. 182.8250 Choline bitartrate. 182.8252 Choline chloride. Subpart C—Anticaking Agents 182.8778 Sodium phosphate. 182.8890 Tocopherols. 182.2122 Aluminum calcium silicate. 182.8892 a-Tocopherol acetate. 182.2227 Calcium silicate. 182.8985 Zinc chloride. 182.2437 Magnesium silicate. 182.8988 Zinc gluconate. 182.2727 Sodium aluminosilicate. 182.8991 Zinc oxide. 182.2729 Sodium calcium aluminosilicate, hydrated. 182.8994 Zinc stearate. 182.2906 Tricalcium silicate. 182.8997 Zinc sulfate. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. Subpart D—Chemical Preservatives SOURCE: 42 FR 14640, Mar. 15, 1977, unless 182.3013 Ascorbic acid. otherwise noted.

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Subpart A—General Provisions Commissioner will offer an opinion, based on specifications and intended § 182.1 Substances that are generally use, as to whether or not a particular recognized as safe. grade or lot of the substance is of suit- (a) It is impracticable to list all sub- able purity for use in food and would stances that are generally recognized generally be regarded as safe for the as safe for their intended use. However, purpose intended, by experts qualified by way of illustration, the Commis- to evaluate its safety. sioner regards such common food in- (c) The inclusion of substances in the gredients as salt, pepper, vinegar, bak- list of nutrients does not constitute a ing powder, and monosodium glu- finding on the part of the Department tamate as safe for their intended use. that the substance is useful as a sup- This part includes additional sub- plement to the diet for humans. stances that, when used for the pur- (d) Substances that are generally rec- poses indicated, in accordance with ognized as safe for their intended use good manufacturing practice, are re- within the meaning of section 409 of garded by the Commissioner as the act are listed in this part. When generaly recognized as safe for such the status of a substance has been re- uses. evaluated, it will be deleted from this (b) For the purposes of this section, part, and will be issued as a new regu- good manufacturing practice shall be lation under the appropriate part, e.g., defined to include the following re- ‘‘affirmed as GRAS’’ under part 184 or strictions: 186 of this chapter; ‘‘food additive regu- (1) The quantity of a substance added lation’’ under parts 170 through 180 of to food does not exceed the amount this chapter; ‘‘interim food additive reasonably required to accomplish its regulation’’ under part 180 of this chap- intended physical, nutritional, or other ter; or ‘‘prohibited from use in food’’ technical effect in food; and under part 189 of this chapter. (2) The quantity of a substance that becomes a component of food as a re- [42 FR 14640, Mar. 15, 1977, as amended at 53 sult of its use in the manufacturing, FR 44875, Nov. 7, 1988] processing, or packaging of food, and which is not intended to accomplish § 182.10 Spices and other natural any physical or other technical effect seasonings and flavorings. in the food itself, shall be reduced to Spices and other natural seasonings the extent reasonably possible. and flavorings that are generally rec- (3) The substance is of appropriate ognized as safe for their intended use, food grade and is prepared and handled within the meaning of section 409 of as a food ingredient. Upon request the the Act, are as follows:

Common name Botanical name of plant source

Alfalfa herb and seed ...... Medicago sativa L. Allspice ...... Pimenta officinalis Lindl. Ambrette seed ...... Hibiscus abelmoschus L. Angelica ...... Angelica archangelica L. or other spp. of Angelica. Angelica root ...... Do. Angelica seed ...... Do. Angostura (cusparia bark) ...... Galipea officinalis Hancock. Anise ...... Pimpinella anisum L. Anise, star ...... Illicium verum Hook. f. Balm (lemon balm) ...... Melissa officinalis L. Basil, bush ...... Ocimum minimum L. Basil, sweet ...... Ocimum basilicum L. Bay ...... Laurus nobilis L. Calendula ...... Calendula officinalis L. Camomile (chamomile), English or Roman ...... Anthemis nobilis L. Camomile (chamomile), German or Hungarian ...... Matricaria chamomilla L. Capers ...... Capparis spinosa L. Capsicum ...... Capsicum frutescens L. or Capsicum annuum L. Caraway ...... Carum carvi L. Caraway, black (black cumin) ...... Nigella sativa L. Cardamom (cardamon) ...... Elettaria cardamomum Maton. Cassia, Chinese ...... Cinnamomum cassia Blume. Cassia, Padang or Batavia ...... Cinnamomum burmanni Blume.

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Common name Botanical name of plant source

Cassia, Saigon ...... Cinnamomum loureirii Nees. Cayenne pepper ...... Capsicum frutescens L. or Capsicum annuum L. Celery seed ...... Apium graveolens L. Chervil ...... Anthriscus cerefolium (L.) Hoffm. Chives ...... Allium schoenoprasum L. Cinnamon, Ceylon ...... Cinnamomum zeylanicum Nees. Cinnamon, Chinese ...... Cinnamomum cassia Blume. Cinnamon, Saigon ...... Cinnamomum loureirii Nees. Clary (clary sage) ...... Salvia sclarea L. Clover ...... Trifolium spp. Coriander ...... Coriandrum sativum L. Cumin (cummin) ...... Cuminum cyminum L. Cumin, black (black caraway) ...... Nigella sativa L. Elder flowers ...... Sambucus canadensis L. Fennel, common ...... Foeniculum vulgare Mill. Fennel, sweet (finocchio, Florence fennel) ...... Foeniculum vulgare Mill. var. duice (DC.) Alex. Fenugreek ...... Trigonella foenum-graecum L. Galanga (galangal) ...... Alpinia officinarum Hance. Geranium ...... Pelargonium spp. Ginger ...... Zingiber officinale Rosc. Grains of paradise ...... Amomum melegueta Rosc. Horehound (hoarhound) ...... Marrubium vulgare L. Horseradish ...... Armoracia lapathifolia Gilib. Hyssop ...... Hyssopus officinalis L. Lavender ...... Lavandula officinalis Chaix. Linden flowers ...... Tilia spp. Mace ...... Myristica fragrans Houtt. Marigold, pot ...... Calendula officinalis L. Marjoram, pot ...... Majorana onites (L.) Benth. Marjoram, sweet ...... Majorana hortensis Moench. Mustard, black or brown ...... Brassica nigra (L.) Koch. Mustard, brown ...... Brassica juncea (L.) Coss. Mustard, white or yellow ...... Brassica hirta Moench. Nutmeg ...... Myristica fragrans Houtt. Oregano (oreganum, Mexican oregano, Mexican Lippia spp. sage, origan). Paprika ...... Capsicum annuum L. Parsley ...... Petroselinum crispum (Mill.) Mansf. Pepper, black ...... Piper nigrum L. Pepper, cayenne ...... Capsicum frutescens L. or Capsicum annuum L. Pepper, red ...... Do. Pepper, white ...... Piper nigrum L. Peppermint ...... Mentha piperita L. Poppy seed ...... Papayer somniferum L. Pot marigold ...... Calendula officinalis L. Pot marjoram ...... Majorana onites (L.) Benth. Rosemary ...... Rosmarinus officinalis L. Saffron ...... Crocus sativus L. Sage ...... Salvia officinalis L. Sage, Greek ...... Salvia triloba L. Savory, summer ...... Satureia hortensis L. (Satureja). Savory, winter ...... Satureia montana L. (Satureja). Sesame ...... Sesamum indicum L. Spearmint ...... Mentha spicata L. Star anise ...... Illicium verum Hook. f. Tarragon ...... Artemisia dracunculus L. Thyme ...... Thymus vulgaris L. Thyme, wild or creeping ...... Thymus serpyllum L. Turmeric ...... Curcuma longa L. Vanilla ...... Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore. Zedoary ...... Curcuma zedoaria Rosc.

[42 FR 14640, Mar. 15, 1977, as amended at 43 FR 3705, Jan. 27, 1978; 44 FR 3963, Jan. 19, 1979; 50 FR 21044, May 22, 1985; 61 FR 14246, Apr. 1, 1996]

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§ 182.20 Essential oils, oleoresins (sol- ing distillates) that are generally rec- vent-free), and natural extractives ognized as safe for their intended use, (including distillates). within the meaning of section 409 of Essential oils, oleoresins (solvent- the Act, are as follows: free), and natural extractives (includ-

Common name Botanical name of plant source

Alfalfa ...... Medicago sativa L. Allspice ...... Pimenta officinalis Lindl. Almond, bitter (free from prussic acid) ...... Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch. Ambrette (seed) ...... Hibiscus moschatus Moench. Angelica root ...... Angelica archangelica L. Angelica seed ...... Do. Angelica stem ...... Do. Angostura (cusparia bark) ...... Galipea officinalis Hancock. Anise ...... Pimpinella anisum L. Asafetida ...... Ferula assa-foetida L. and related spp. of Ferula. Balm (lemon balm) ...... Melissa officinalis L. Balsam of Peru ...... Myroxylon pereirae Klotzsch. Basil ...... Ocimum basilicum L. Bay leaves ...... Laurus nobilis L. Bay (myrcia oil) ...... Pimenta racemosa (Mill.) J. W. Moore. Bergamot (bergamot orange) ...... Citrus aurantium L. subsp. bergamia Wright et Arn. Bitter almond (free from prussic acid) ...... Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch. Bois de rose ...... Aniba rosaeodora Ducke. Cacao ...... Theobroma cacao L. Camomile (chamomile) flowers, Hungarian ...... Matricaria chamomilla L. Camomile (chamomile) flowers, Roman or English Anthemis nobilis L. Cananga ...... Cananga odorata Hook. f. and Thoms. Capsicum ...... Capsicum frutescens L. and Capsicum annuum L. Caraway ...... Carum carvi L. Cardamom seed (cardamon) ...... Elettaria cardamomum Maton. Carob bean ...... Ceratonia siliqua L. Carrot ...... Daucus carota L. Cascarilla bark ...... Croton eluteria Benn. Cassia bark, Chinese ...... Cinnamomum cassia Blume. Cassia bark, Padang or Batavia ...... Cinnamomum burmanni Blume. Cassia bark, Saigon ...... Cinnamomum loureirii Nees. Celery seed ...... Apium graveolens L. Cherry, wild, bark ...... Prunus serotina Ehrh. Chervil ...... Anthriscus cerefolium (L.) Hoffm. Chicory ...... Cichorium intybus L. Cinnamon bark, Ceylon ...... Cinnamomum zeylanicum Nees. Cinnamon bark, Chinese ...... Cinnamomum cassia Blume. Cinnamon bark, Saigon ...... Cinnamomum loureirii Nees. Cinnamon leaf, Ceylon ...... Cinnamomum zeylanicum Nees. Cinnamon leaf, Chinese ...... Cinnamomum cassia Blume. Cinnamon leaf, Saigon ...... Cinnamomum loureirii Nees. Citronella ...... Cymbopogon nardus Rendle. Citrus peels ...... Citrus spp. Clary (clary sage) ...... Salvia sclarea L. Clover ...... Trifolium spp. Coca (decocainized) ...... Erythroxylum coca Lam. and other spp. of Erythroxylum. Coffee ...... Coffea spp. Cola nut ...... Cola acuminata Schott and Endl., and other spp. of Cola. Coriander ...... Coriandrum sativum L. Cumin (cummin) ...... Cuminum cyminum L. Curacao orange peel (orange, bitter peel) ...... Citrus aurantium L. Cusparia bark ...... Galipea officinalis Hancock. Dandelion ...... Taraxacum officinale Weber and T. laevigatum DC. Dandelion root ...... Do. Dog grass (quackgrass, triticum) ...... Agropyron repens (L.) Beauv. Elder flowers ...... Sambucus canadensis L. and S. nigra I. Estragole (esdragol, esdragon, tarragon) ...... Artemisia dracunculus L. Estragon (tarragon) ...... Do. Fennel, sweet ...... Foeniculum vulgare Mill. Fenugreek ...... Trigonella foenum-graecum L. Galanga (galangal) ...... Alpinia officinarum Hance. Geranium ...... Pelargonium spp. Geranium, East Indian ...... Cymbopogon martini Stapf. Geranium, rose ...... Pelargonium graveolens L’Her. Ginger ...... Zingiber officinale Rosc.

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Common name Botanical name of plant source

Grapefruit ...... Citrus paradisi Macf. Guava ...... Psidium spp. Hickory bark ...... Carya spp. Horehound (hoarhound) ...... Marrubium vulgare L. Hops ...... Humulus lupulus L. Horsemint ...... Monarda punctata L. Hyssop ...... Hyssopus officinalis L. Immortelle ...... Helichrysum augustifolium DC. Jasmine ...... Jasminum officinale L. and other spp. of Jasminum. Juniper (berries) ...... Juniperus communis L. Kola nut ...... Cola acuminata Schott and Endl., and other spp. of Cola. Laurel berries ...... Laurus nobilis L. Laurel leaves ...... Laurus spp. Lavender ...... Lavandula officinalis Chaix. Lavender, spike ...... Lavandula latifolia Vill. Lavandin ...... Hybrids between Lavandula officinalis Chaix and Lavandula latifolin Vill. Lemon ...... Citrus limon (L.) Burm. f. Lemon balm (see balm). Lemon grass ...... Cymbopogon citratus DC. and Cymbopogon lexuosus Stapf. Lemon peel ...... Citrus limon (L.) Burm. f. Lime ...... Citrus aurantifolia Swingle. Linden flowers ...... Tilia spp. Locust bean ...... Ceratonia siliqua L, Lupulin ...... Humulus lupulus L. Mace ...... Myristica fragrans Houtt. Mandarin ...... Citrus reticulata Blanco. Marjoram, sweet ...... Majorana hortensis Moench. Mate´ ...... Ilex paraguariensis St. Hil. Melissa (see balm). Menthol ...... Mentha spp. Menthyl acetate ...... Do. Molasses (extract) ...... Saccarum officinarum L. Mustard ...... Brassica spp. Naringin ...... Citrus paradisi Macf. Neroli, bigarade ...... Citrus aurantium L. Nutmeg ...... Myristica fragrans Houtt. Onion ...... Allium cepa L. Orange, bitter, flowers ...... Citrus aurantium L. Orange, bitter, peel ...... Do. Orange leaf ...... Citrus sinensis (L.) Osbeck. Orange, sweet ...... Do. Orange, sweet, flowers ...... Do. Orange, sweet, peel ...... Do. Origanum ...... Origanum spp. Palmarosa ...... Cymbopogon martini Stapf. Paprika ...... Capsicum annuum L. Parsley ...... Petroselinum crispum (Mill.) Mansf. Pepper, black ...... Piper nigrum L. Pepper, white ...... Do. Peppermint ...... Mentha piperita L. Peruvian balsam ...... Myroxylon pereirae Klotzsch. Petitgrain ...... Citrus aurantium L. Petitgrain lemon ...... Citrus limon (L.) Burm. f. Petitgrain mandarin or tangerine ...... Citrus reticulata Blanco. Pimenta ...... Pimenta officinalis Lindl. Pimenta leaf ...... Pimenta officinalis Lindl. Pipsissewa leaves ...... Chimaphila umbellata Nutt. Pomegranate ...... Punica granatum L. Prickly ash bark ...... Xanthoxylum (or Zanthoxylum) Americanum Mill. or Xanthoxylum clava- herculis L. Rose absolute ...... Rosa alba L., Rosa centifolia L., Rosa damascena Mill., Rosa gallica L., and vars. of these spp. Rose (otto of roses, attar of roses) ...... Do. Rose buds ...... Do. Rose flowers ...... Do. Rose fruit (hips) ...... Do. Rose geranium ...... Pelargonium graveolens L’Her. Rose leaves ...... Rosa spp. Rosemary ...... Rosmarinus officinalis L. Saffron ...... Crocus sativus L. Sage ...... Salvia officinalis L. Sage, Greek ...... Salvia triloba L. Sage, Spanish ...... Salvia lavandulaefolia Vahl. St. John’s bread ...... Ceratonia siliqua L.

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Common name Botanical name of plant source

Savory, summer ...... Satureia hortensis L. Savory, winter ...... Satureia montana L. Schinus molle ...... Schinus molle L. Sloe berries (blackthorn berries) ...... Prunus spinosa L. Spearmint ...... Mentha spicata L. Spike lavender ...... Lavandula latifolia Vill. Tamarind ...... Tamarindus indica L. Tangerine ...... Citrus reticulata Blanco. Tarragon ...... Artemisia dracunculus L. Tea ...... Thea sinensis L. Thyme ...... Thymus vulgaris L. and Thymus zygis var. gracilis Boiss. Thyme, white ...... Do. Thyme, wild or creeping ...... Thymus serpyllum L. Triticum (see dog grass). Tuberose ...... Polianthes tuberosa L. Turmeric ...... Curcuma longa L. Vanilla ...... Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore. Violet flowers ...... Viola odorata L. Violet leaves ...... Do. Violet leaves absolute ...... Do. Wild cherry bark ...... Prunus serotina Ehrh. Ylang-ylang ...... Cananga odorata Hook. f. and Thoms. Zedoary bark ...... Curcuma zedoaria Rosc.

[42 FR 14640, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979; 47 FR 29953, July 9, 1982; 48 FR 51613, Nov. 10, 1983; 50 FR 21043 and 21044, May 22, 1985]

§ 182.40 Natural extractives (solvent- seasonings, and flavorings that are free) used in conjunction with generally recognized as safe for their spices, seasonings, and flavorings. intended use, within the meaning of Natural extractives (solvent-free) section 409 of the Act, are as follows: used in conjunction with spices,

Common name Botanical name of plant source

Apricot kernel (persic oil) ...... Prunus armeniaca L. Peach kernel (persic oil) ...... Prunus persica Sieb. et Zucc. Peanut stearine ...... Arachis hypogaea L. Persic oil (see apricot kernel and peach kernel). Quince seed ...... Cydonia oblonga Miller.

[42 FR 14640, Mar. 15, 1977, as amended at 47 FR 47375, Oct. 26, 1982]

§ 182.50 Certain other spices, tracts that are generally recognized as seasonings, essential oils, safe for their intended use, within the oleoresins, and natural extracts. meaning of section 409 of the Act, are Certain other spices, seasonings, es- as follows: sential oils, oleoresins, and natural ex-

Common name Derivation

Ambergris ...... Physeter macrocephalus L. Castoreum ...... Castor fiber L. and C. canadensis Kuhl. Civet (zibeth, zibet, zibetum) ...... Civet cats, Viverra civetta Schreber and Viverra zibetha Schreber. Cognac oil, white and green ...... Ethyl oenanthate, so-called. Musk (Tonquin musk) ...... Musk deer, Moschus moschiferus L.

§ 182.60 Synthetic flavoring substances nized as safe for their intended use, and adjuvants. within the meaning of section 409 of Synthetic flavoring substances and the Act, are as follows: adjuvants that are generally recog- Acetaldehyde (ethanal).

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Acetoin (acetyl methylcarbinol). Zinc chloride. Anethole (parapropenyl anisole). [42 FR 14640, Mar. 15, 1977, as amended at 43 Benzaldehyde (benzoic aldehyde). FR 11698, Mar. 21, 1978; 44 FR 28323, May 15, N-Butyric acid (butanoic acid). 1979; 45 FR 6085, Jan. 25, 1980; 47 FR 27807, d- or l-Carvone (carvol). 27814, June 25, 1982; 48 FR 51150, Nov. 7, 1983; Cinnamaldehyde (cinnamic aldehyde). 48 FR 51616, Nov. 10, 1983; 48 FR 51909, Nov. 15, Citral (2,6-dimethyloctadien-2,6-al-8, gera- 1983; 48 FR 52441, 52443, 52445, 52446, Nov. 18, nial, neral). 1983; 51 FR 16830, May 7, 1986; 51 FR 27171, Decanal ( -decylaldehyde, capraldehyde, N July 30, 1986; 60 FR 62208, Dec. 5, 1995] capric aldehyde, caprinaldehyde, aldehyde C-10). § 182.90 Substances migrating to food Ethyl acetate. from paper and paperboard prod- Ethyl butyrate. ucts. 3-Methyl-3-phenyl glycidic acid ethyl ester (ethyl-methyl-phenyl-glycidate, so-called Substances migrating to food from strawberry aldehyde, C-16 aldehyde). paper and paperboard products used in Ethyl vanillin. food packaging that are generally rec- Geraniol (3,7-dimethyl-2,6 and 3,6-octadien-1- ognized as safe for their intended use, ol). within the meaning of section 409 of Geranyl acetate (geraniol acetate). Limonene (d-, l-, and dl-). the Act, are as follows: Linalool (linalol, 3,7-dimethyl-1,6-octadien-3- Alum (double sulfate of aluminum and am- ol). monium potassium, or sodium). Linalyl acetate (bergamol). Aluminum hydroxide. Methyl anthranilate (methyl-2- Aluminum oleate. aminobenzoate). Aluminum palmitate. Piperonal (3,4-methylenedioxy-benzaldehyde, Casein. heliotropin). Cellulose acetate. Vanillin. Cornstarch. [42 FR 14640, Mar. 15, 1977, as amended at 43 Diatomaceous earth filler. FR 47724, Oct. 17, 1978; 44 FR 3963, Jan. 19, Ethyl cellulose. 1979; 44 FR 20656, Apr. 6, 1979; 48 FR 51907, Ethyl vanillin. Nov. 15, 1983; 54 FR 7402, Feb. 21, 1989] Glycerin. Oleic acid. § 182.70 Substances migrating from Potassium sorbate. cotton and cotton fabrics used in Silicon dioxides. dry food packaging. Sodium aluminate. Sodium chloride. Substances migrating to food from Sodium hexametaphosphate. cotton and cotton fabrics used in dry Sodium hydrosulfite. food packaging that are generally rec- Sodium phosphoaluminate. ognized as safe for their intended use, Sodium silicate. within the meaning of section 409 of Sodium sorbate. the Act, are as follows: Sodium tripolyphosphate. Sorbitol. Beef tallow. Soy protein, isolated. Carboxymethylcellulose. Starch, acid modified. Coconut oil, refined. Starch, pregelatinized. Cornstarch. Starch, unmodified. Gelatin. Talc. Lard. Vanillin. Lard oil. Zinc hydrosulfite. Oleic acid. Zinc sulfate. Peanut oil. Potato starch. [42 FR 14640, Mar. 15, 1977] Sodium acetate. EDITORIAL NOTE: For additional FEDERAL Sodium chloride. REGISTER citations affecting § 182.90, see the Sodium silicate. List of CFR Sections Affected, which appears Sodium tripolyphosphate. in the Finding Aids section of the printed Soybean oil (hydrogenated). volume and on GPO Access. Talc. Tallow (hydrogenated). § 182.99 Adjuvants for pesticide chemi- Tallow flakes. cals. Tapioca starch. Tetrasodium pyrophosphate. Adjuvants, identified and used in ac- Wheat starch. cordance with 40 CFR 180.1001 (c) and

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(d), which are added to pesticide use di- used in accordance with good manufac- lutions by a grower or applicator prior turing practice. to application to the raw agricultural commodity, are exempt from the re- § 182.1127 Aluminum ammonium sul- quirement of tolerances under section fate. 409 of the Act. (a) Product. Aluminum ammonium sulfate. Subpart B—Multiple Purpose GRAS (b) Conditions of use. This substance Food Substances is generally recognized as safe when used in accordance with good manufac- § 182.1045 Glutamic acid. turing practice. (a) Product. Glutamic acid. § 182.1129 Aluminum potassium sul- (b) [Reserved] fate. (c) Limitations, restrictions, or expla- (a) Product. Aluminum potassium sul- nation. This substance is generally rec- fate. ognized as safe when used as a salt sub- (b) Conditions of use. This substance stitute in accordance with good manu- is generally recognized as safe when facturing practice. used in accordance with good manufacturing practice. § 182.1047 Glutamic acid hydrochloride. § 182.1131 Aluminum sodium sulfate. (a) Product. Glutamic acid hydro- (a) Product. Aluminum sodium sul- chloride. fate. (b) [Reserved] (b) Conditions of use. This substance (c) Limitations, restrictions, or expla- is generally recognized as safe when nation. This substance is generally rec- used in accordance with good manufac- ognized as safe when used as a salt sub- turing practice. stitute in accordance with good manufacturing practice. § 182.1180 Caffeine. (a) Product. Caffeine. § 182.1057 Hydrochloric acid. (b) Tolerance. 0.02 percent. (a) Product. Hydrochloric acid. (c) Limitations, restrictions, or expla- (b) [Reserved] nation. This substance is generally rec- (c) Limitations, restrictions, or expla- ognized as safe when used in cola-type nation. This substance is generally rec- beverages in accordance with good ognized as safe when used as a buffer manufacturing practice. and neutralizing agent in accordance with good manufacturing practice. § 182.1217 Calcium phosphate. (a) Product. Calcium phosphate § 182.1073 Phosphoric acid. (mono-, di-, and tribasic). (a) Product. Phosphoric acid. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing practice. turing practice. § 182.1235 Caramel. § 182.1087 Sodium acid pyrophosphate. (a) Product. Caramel. (a) Product. Sodium acid (b) Conditions of use. This substance pyrophosphate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufacturing practice. § 182.1320 Glycerin. (a) Product. Glycerin. § 182.1125 Aluminum sulfate. (b) Conditions of use. This substance (a) Product. Aluminum sulfate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice.

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§ 182.1480 Methylcellulose. § 182.1748 Sodium caseinate. (a) Product. U.S.P. methylcellulose, (a) Product. Sodium caseinate. except that the methoxy content shall (b) Conditions of use. This substance not be less than 27.5 percent and not is generally recognized as safe when more than 31.5 percent on a dry-weight used in accordance with good manufac- basis. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.1778 Sodium phosphate. used in accordance with good manufac- (a) Product. Sodium phosphate turing practice. (mono-, di-, and tribasic). (b) Conditions of use. This substance § 182.1500 Monoammonium glutamate. is generally recognized as safe when (a) Product. Monoammonium glu- used in accordance with good manufacturing practice. tamate. (b) Conditions of use. This substance § 182.1781 Sodium aluminum phos- is generally recognized as safe when phate. used in accordance with good manufac- (a) Product. Sodium aluminum phos- turing practice. phate. § 182.1516 Monopotassium glutamate. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Monopotassium glu- used in accordance with good manufac- tamate. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.1810 Sodium tripolyphosphate. used in accordance with good manufac- (a) Product. Sodium turing practice. tripolyphosphate. (b) Conditions of use. This substance § 182.1711 Silica aerogel. is generally recognized as safe when (a) Product. Silica aerogel as a finely used in accordance with good manufac- powdered microcellular silica foam turing practice. having a minimum silica content of 89.5 percent. Subpart C—Anticaking Agents (b) [Reserved] (c) Limitations, restrictions, or expla- § 182.2122 Aluminum calcium silicate. nation. This substance is generally rec- (a) Product. Aluminum calcium sili- ognized as safe when used as a compo- cate. nent of an anti-foaming agent in ac- (b) Tolerance. 2 percent. cordance with good manufacturing (c) Limitations, restrictions, or expla- practice. nation. This substance is generally recognized as safe when used in table salt § 182.1745 Sodium carboxymethylcellu- in accordance with good manufacturing lose. practice. (a) Product. Sodium carboxymethylcellulose is the sodium salt of § 182.2227 Calcium silicate. carboxymethylcellulose not less than (a) Product. Calcium silicate. 99.5 percent on a dry-weight basis, with (b) Tolerance. 2 percent and 5 percent. maximum substitution of 0.95 (c) Limitations, restrictions, or expla- carboxymethyl groups per nation. This substance is generally rec- anhydroglucose unit, and with a min- ognized as safe when used at levels not imum viscosity of 25 centipoises for 2 exceeding 2 percent in table salt and 5 percent by weight aqueous solution at percent in baking powder in accordance 25 °C. with good manufacturing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.2437 Magnesium silicate. used in accordance with good manufac- (a) Product. Magnesium silicate. turing practice. (b) Tolerance. 2 percent.

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(c) Limitations, restrictions, or expla- § 182.3109 Thiodipropionic acid. nation. This substance is generally rec- (a) Product. Thiodipropionic acid. ognized as safe when used in table salt in accordance with good manufacturing (b) Tolerance. This substance is gen- practice. erally recognized as safe for use in food when the total content of antioxidants § 182.2727 Sodium aluminosilicate. is not over 0.02 percent of fat or oil (a) Product. Sodium aluminosilicate content, including essential (volatile) (sodium silicoaluminate). oil content of the food, provided the (b) Tolerance. This substance is gen- substance is used in accordance with erally recognized as safe for use at a good manufacturing practice. level not exceeding 2 percent in accordance with good manufacturing prac- § 182.3149 Ascorbyl palmitate. tice. (a) Product. Ascorbyl palmitate. (b) Conditions of use. This substance § 182.2729 Sodium calcium is generally recognized as safe when aluminosilicate, hydrated. used in accordance with good manufac- (a) Product. Hydrated sodium calcium turing practice. aluminosilicate (sodium calcium silicoaluminate). § 182.3169 Butylated hydroxyanisole. (b) Tolerance. This substance is gen- (a) Butylated hydroxy- erally recognized as safe for use at a Product. level not exceeding 2 percent in accord- anisole. ance with good manufacturing prac- (b) Tolerance. This substance is gen- tice. erally recognized as safe for use in food when the total content of antioxidants § 182.2906 Tricalcium silicate. is not over 0.02 percent of fat or oil (a) Product. Tricalcium silicate. content, including essential (volatile) (b) Tolerance. 2 percent. oil content of food, provided the sub- (c) Limitations, restrictions, or expla- stance is used in accordance with good nation. This substance is generally rec- manufacturing practice. ognized as safe when used in table salt in accordance with good manufacturing § 182.3173 Butylated hydroxytoluene. practice. (a) Product. Butylated hydroxytoluene. Subpart D—Chemical (b) Tolerance. This substance is gen- Preservatives erally recognized as safe for use in food when the total content of antioxidants § 182.3013 Ascorbic acid. is not over 0.02 percent of fat or oil (a) Product. Ascorbic acid. content, including essential (volatile) (b) Conditions of use. This substance oil content of food, provided the sub- is generally recognized as safe when stance is used in accordance with good used in accordance with good manufac- manufacturing practice. turing practice. § 182.3189 Calcium ascorbate. § 182.3041 Erythorbic acid. (a) Product. Calcium ascorbate. (a) Product. Erythorbic acid. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing practice. turing practice.

§ 182.3089 Sorbic acid. § 182.3225 Calcium sorbate. (a) Product. Sorbic acid. (a) Product. Calcium sorbate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing practice. turing practice.

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§ 182.3280 Dilauryl thiodipropionate. used in accordance with good manufacturing practice. (a) Product. Dilauryl thiodipropionate. § 182.3739 Sodium bisulfite. (b) Tolerance. This substance is generally recognized as safe for use in food (a) Product. Sodium bisulfite. when the total content of antioxidants (b) [Reserved] is not over 0.02 percent of fat or oil (c) Limitations, restrictions, or expla- content, including essential (volatile) nation. This substance is generally rec- oil content of the food, provided the ognized as safe when used in accord- substance is used in accordance with ance with good manufacturing prac- good manufacturing practice. tice, except that it is not used in meats; in food recognized as a source of § 182.3616 Potassium bisulfite. vitamin B1; on fruits or vegetables in- (a) Product. Potassium bisulfite. tended to be served raw to consumers (b) [Reserved] or sold raw to consumers, or to be pre- (c) Limitations, restrictions, or expla- sented to the consumer as fresh. nation. This substance is generally recognized as safe when used in accord- [42 FR 14640, Mar. 15, 1977, as amended at 51 ance with good manufacturing prac- FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994] tice, except that it is not used in meats; in food recognized as a source of § 182.3766 Sodium metabisulfite. vitamin B1; on fruits and vegetables intended to be served raw to consumers (a) Product. Sodium metabisulfite. or sold raw to consumers, or to be pre- (b) [Reserved] sented to consumers as fresh. (c) Limitations, restrictions, or explanation. This substance is generally rec- [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, ognized as safe when used in accord- 1990; 59 FR 65939, Dec. 22, 1994] ance with good manufacturing practice, except that it is not used in § 182.3637 Potassium metabisulfite. meats; in food recognized as a source of (a) Product. Potassium metabisulfite. vitamin B1; on fruits or vegetables in- (b) [Reserved] tended to be served raw to consumers (c) Limitations, restrictions, or expla- or sold raw to consumers, or to be pre- nation. This substance is generally rec- sented to consumers as fresh. ognized as safe when used in accord- [42 FR 14640, Mar. 15, 1977, as amended at 51 ance with good manufacturing prac- FR 25025, July 9, 1986; 55 FR 9833, Mar. 15, tice, except that it is not used in 1990; 59 FR 65939, Dec. 22, 1994] meats; in food recognized as a source of vitamin B1; on fruits and vegetables in- § 182.3795 Sodium sorbate. tended to be served raw to consumers (a) Product. Sodium sorbate. or sold raw to consumers, or to be pre- sented to consumers as fresh. (b) Conditions of use. This substance is generally recognized as safe when [42 FR 14640, Mar. 15, 1977, as amended at 51 used in accordance with good manufac- FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, turing practice. 1990; 59 FR 65939, Dec. 22, 1994]

§ 182.3640 Potassium sorbate. § 182.3798 Sodium sulfite. (a) Product. Potassium sorbate. (a) Product. Sodium sulfite. (b) Conditions of use. This substance (b) [Reserved] is generally recognized as safe when (c) Limitations, restrictions, or expla- used in accordance with good manufac- nation. This substance is generally rec- turing practice. ognized as safe when used in accordance with good manufacturing prac- § 182.3731 Sodium ascorbate. tice, except that it is not used in (a) Product. Sodium ascorbate. meats; in food recognized as a source of (b) Conditions of use. This substance vitamin B1; on fruits or vegetables in- is generally recognized as safe when tended to be served raw to consumers

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or sold raw to consumers, or to be pre- § 182.6203 Calcium sented to consumers as fresh. hexametaphosphate. [42 FR 14640, Mar. 15, 1977, as amended at 51 (a) Product. Calcium FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, hexametaphosphate. 1990; 59 FR 65939, Dec. 22, 1994] (b) Conditions of use. This substance is generally recognized as safe when § 182.3862 Sulfur dioxide. used in accordance with good manufac- (a) Product. Sulfur dioxide. turing practice. (b) [Reserved] § 182.6215 Monobasic calcium phos- (c) Limitations, restrictions, or expla- phate. nation. This substance is generally recognized as safe when used in accord- (a) Product. Monobasic calcium phos- ance with good manufacturing prac- phate. tice, except that it is not used in (b) Conditions of use. This substance meats; in food recognized as a source of is generally recognized as safe when used in accordance with good manufac- vitamin B1; on fruits or vegetables intended to be served raw to consumers turing practice. or sold raw to consumers, or to be pre- § 182.6285 Dipotassium phosphate. sented to consumers as fresh. (a) Product. Dipotassium phosphate. [42 FR 14640, Mar. 15, 1977, as amended at 51 (b) Conditions of use. This substance FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, is generally recognized as safe when 1990; 59 FR 65939, Dec. 22, 1994] used in accordance with good manufac- § 182.3890 Tocopherols. turing practice. (a) Product. Tocopherols. § 182.6290 Disodium phosphate. (b) Conditions of use. This substance (a) Product. Disodium phosphate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufacturing practice. Subpart E—Emulsifying Agents [Reserved] § 182.6757 Sodium gluconate. (a) Product. Sodium gluconate. Subpart F—Dietary Supplements (b) Conditions of use. This substance [Reserved] is generally recognized as safe when used in accordance with good manufacturing practice. Subpart G—Sequestrants 1 § 182.6760 Sodium § 182.6085 Sodium acid phosphate. hexametaphosphate. (a) Product. Sodium acid phosphate. (a) Product. Sodium (b) Conditions of use. This substance hexametaphosphate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufacturing practice. § 182.6197 Calcium diacetate. (a) Product. Calcium diacetate. § 182.6769 Sodium metaphosphate. (b) Conditions of use. This substance (a) Product. Sodium metaphosphate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufacturing practice.

1 For the purpose of this subpart, no at- § 182.6778 Sodium phosphate. tempt has been made to designate those sequestrants that may also function as (a) Product. Sodium phosphate chemical preservatives. (mono-, di-, and tribasic).

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(b) Conditions of use. This substance § 182.8217 Calcium phosphate. is generally recognized as safe when (a) Product. Calcium phosphate used in accordance with good manufac- (mono-, di-, and tribasic). turing practice. (b) Conditions of use. This substance § 182.6787 Sodium pyrophosphate. is generally recognized as safe when used in accordance with good manufac- (a) Product. Sodium pyrophosphate. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.8223 Calcium pyrophosphate. used in accordance with good manufac- (a) Product. Calcium pyrophosphate. turing practice. (b) Conditions of use. This substance § 182.6789 Tetra sodium is generally recognized as safe when pyrophosphate. used in accordance with good manufacturing practice. (a) Product. Tetra sodium pyrophosphate. § 182.8250 Choline bitartrate. (b) Conditions of use. This substance (a) Product. Choline bitartrate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- § 182.6810 Sodium tripolyphosphate. turing practice. (a) Product. Sodium § 182.8252 Choline chloride. tripolyphosphate. (a) Product. Choline chloride. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing practice. turing practice.

Subpart H—Stabilizers § 182.8778 Sodium phosphate. (a) Product. Sodium phosphate § 182.7255 Chondrus extract. (mono-, di-, and tribasic). (a) Product. Chondrus extract (b) Conditions of use. This substance (carrageenin). is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufacturing practice. § 182.8890 Tocopherols. (a) Product. Tocopherols. Subpart I—Nutrients (b) Conditions of use. This substance is generally recognized as safe when SOURCE: 45 FR 58838, Sept. 5, 1980, unless used in accordance with good manufac- otherwise noted. turing practice.

§ 182.8013 Ascorbic acid. § 182.8892 α-Tocopherol acetate. (a) Product. Ascorbic acid. (a) Product. a-Tocopherol acetate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing practice. turing practice.

§ 182.8159 Biotin. § 182.8985 Zinc chloride. (a) Product. Biotin. (a) Product. Zinc chloride. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing practice. turing practice.

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§ 182.8988 Zinc gluconate. 184.1077 Potassium acid tartrate. 184.1081 Propionic acid. (a) Product. Zinc gluconate. 184.1090 Stearic acid. (b) Conditions of use. This substance 184.1091 Succinic acid. is generally recognized as safe when 184.1095 Sulfuric acid. used in accordance with good manufac- 184.1097 Tannic acid. turing practice. 184.1099 Tartaric acid. 184.1101 Diacetyl tartaric acid esters of § 182.8991 Zinc oxide. mono- and diglycerides. 184.1115 Agar-agar. (a) Product. Zinc oxide. 184.1120 Brown algae. (b) Conditions of use. This substance 184.1121 Red algae. is generally recognized as safe when 184.1133 Ammonium alginate. used in accordance with good manufac- 184.1135 Ammonium bicarbonate. turing practice. 184.1137 Ammonium carbonate. 184.1138 Ammonium chloride. § 182.8994 Zinc stearate. 184.1139 Ammonium hydroxide. 184.1140 Ammonium citrate, dibasic. (a) Product. Zinc stearate prepared 184.1141a Ammonium phosphate, monobasic. from stearic acid free from chickedema 184.1141b Ammonium phosphate, dibasic. factor. 184.1143 Ammonium sulfate. (b) Conditions of use. This substance 184.1148 Bacterially-derived carbohydrase is generally recognized as safe when enzyme preparation. 184.1150 Bacterially-derived protease en- used in accordance with good manufac- zyme preparation. turing practice. 184.1155 Bentonite. 184.1157 Benzoyl peroxide. § 182.8997 Zinc sulfate. 184.1165 n–Butane and iso–butane. (a) Product. Zinc sulfate. 184.1185 Calcium acetate. (b) Conditions of use. This substance 184.1187 Calcium alginate. 184.1191 Calcium carbonate. is generally recognized as safe when 184.1193 Calcium chloride. used in accordance with good manufac- 184.1195 Calcium citrate. turing practice. 184.1199 Calcium gluconate. 184.1201 Calcium glycerophosphate. PART 184—DIRECT FOOD SUB- 184.1205 Calcium hydroxide. 184.1206 Calcium iodate. STANCES AFFIRMED AS GEN- 184.1207 Calcium lactate. ERALLY RECOGNIZED AS SAFE 184.1210 Calcium oxide. 184.1212 Calcium pantothenate. Subpart A—General Provisions 184.1221 Calcium propionate. 184.1229 Calcium stearate. Sec. 184.1230 Calcium sulfate. 184.1 Substances added directly to human 184.1240 Carbon dioxide. food affirmed as generally recognized as 184.1245 Beta-carotene. safe (GRAS). 184.1250 Cellulase enzyme preparation derived from Trichoderma longibrachi- Subpart B—Listing of Specific Substances atum. Affirmed as GRAS 184.1257 Clove and its derivatives. 184.1259 Cocoa butter substitute. 184.1005 Acetic acid. 184.1260 Copper gluconate. 184.1007 Aconitic acid. 184.1261 Copper sulfate. 184.1009 Adipic acid. 184.1262 Corn silk and corn silk extract. 184.1011 Alginic acid. 184.1265 Cuprous iodide. 184.1012 a-Amylase enzyme preparation 184.1271 L-Cysteine. from Bacillus stearothermophilus. 184.1272 L-Cysteine monohydrochloride. 184.1021 Benzoic acid. 184.1277 Dextrin. 184.1024 Bromelain. 184.1278 Diacetyl. 184.1025 Caprylic acid. 184.1282 Dill and its derivatives. 184.1027 Mixed carbohydrase and protease 184.1287 Enzyme-modified fats. enzyme product. 184.1293 Ethyl alcohol. 184.1033 Citric acid. 184.1295 Ethyl formate. 184.1034 Catalase (bovine liver). 184.1296 Ferric ammonium citrate. 184.1061 Lactic acid. 184.1297 Ferric chloride. 184.1063 Enzyme-modified lecithin. 184.1298 Ferric citrate. 184.1065 Linoleic acid. 184.1301 Ferric phosphate. 184.1069 Malic acid. 184.1304 Ferric pyrophosphate.

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184.1307 Ferric sulfate. 184.1555 Rapeseed oil. 184.1307a Ferrous ascorbate. 184.1560 Ox bile extract. 184.1307b Ferrous carbonate. 184.1563 Ozone. 184.1307c Ferrous citrate. 184.1583 Pancreatin. 184.1307d Ferrous fumarate. 184.1585 Papain. 184.1308 Ferrous gluconate. 184.1588 Pectins. 184.1311 Ferrous lactate. 184.1595 Pepsin. 184.1315 Ferrous sulfate. 184.1610 Potassium alginate. 184.1316 Ficin. 184.1613 Potassium bicarbonate. 184.1317 Garlic and its derivatives. 184.1619 Potassium carbonate. 184.1318 Glucono delta-lactone. 184.1622 Potassium chloride. 184.1321 Corn gluten. 184.1625 Potassium citrate. 184.1322 Wheat gluten. 184.1631 Potassium hydroxide. 184.1323 Glyceryl monooleate. 184.1634 Potassium iodide. 184.1324 Glyceryl monostearate. 184.1635 Potassium iodate. 184.1328 Glyceryl behenate. 184.1639 Potassium lactate. 184.1329 Glyceryl palmitostearate. 184.1643 Potassium sulfate. 184.1330 Acacia (gum arabic). 184.1655 Propane. 184.1333 Gum ghatti. 184.1660 Propyl gallate. 184.1339 Guar gum. 184.1666 Propylene glycol. 184.1343 Locust (carob) bean gum. 184.1670 Propylparaben. 184.1349 Karaya gum (sterculia gum). 184.1676 Pyridoxine hydrochloride. 184.1351 Gum tragacanth. 184.1685 Rennet (animal-derived) and 184.1355 Helium. chymosin preparation (fermentation-de- 184.1366 Hydrogen peroxide. rived). 184.1370 Inositol. 184.1695 Riboflavin. 184.1372 Insoluble glucose isomerase enzyme 184.1697 Riboflavin-5′-phosphate (sodium). preparations. 184.1698 Rue. 184.1375 Iron, elemental. 184.1699 Oil of rue. 184.1386 Isopropyl citrate. 184.1702 Sheanut oil. 184.1387 Lactase enzyme preparation from 184.1721 Sodium acetate. Candida pseudotropicalis. 184.1724 Sodium alginate. 184.1388 Lactase enzyme preparation from 184.1733 Sodium benzoate. Kluyveromyces lactis. 184.1736 Sodium bicarbonate. 184.1400 Lecithin. 184.1742 Sodium carbonate. 184.1408 Licorice and licorice derivatives. 184.1751 Sodium citrate. 184.1409 Ground limestone. 184.1754 Sodium diacetate. 184.1415 Animal lipase. 184.1763 Sodium hydroxide. 184.1420 Lipase enzyme preparation derived 184.1764 Sodium hypophosphite. from Rhizopus niveus. 184.1768 Sodium lactate. 184.1425 Magnesium carbonate. 184.1769a Sodium metasilicate. 184.1426 Magnesium chloride. 184.1784 Sodium propionate. 184.1428 Magnesium hydroxide. 184.1792 Sodium sesquicarbonate. 184.1431 Magnesium oxide. 184.1801 Sodium tartrate. 184.1434 Magnesium phosphate. 184.1804 Sodium potassium tartrate. 184.1440 Magnesium stearate. 184.1807 Sodium thiosulfate. 184.1443 Magnesium sulfate. 184.1835 Sorbitol. 184.1443a Malt. 184.1845 Stannous chloride (anhydrous and 184.1444 Maltodextrin. dihydrated). 184.1445 Malt syrup (malt extract). 184.1848 Starter distillate. 184.1446 Manganese chloride. 184.1851 Stearyl citrate 184.1449 Manganese citrate. 184.1854 Sucrose. 184.1452 Manganese gluconate. 184.1857 Corn sugar. 184.1461 Manganese sulfate. 184.1859 Invert sugar. 184.1472 Menhaden oil. 184.1865 Corn syrup. 184.1490 Methylparaben. 184.1866 High fructose corn syrup. 184.1498 Microparticulated protein product. 184.1875 Thiamine hydrochloride. 184.1505 Mono- and diglycerides. 184.1878 Thiamine mononitrate. 184.1521 Monosodium phosphate derivatives 184.1890 a-Tocopherols. of mono- and diglycerides. 184.1901 Triacetin. 184.1530 Niacin. 184.1903 Tributyrin. 184.1535 Niacinamide. 184.1911 Triethyl citrate. 184.1537 Nickel. 184.1914 Trypsin. 184.1538 Nisin preparation. 184.1923 Urea. 184.1540 Nitrogen. 184.1924 Urease enzyme preparation from 184.1545 Nitrous oxide. Lactobacillus fermentum. 184.1553 Peptones. 184.1930 Vitamin A.

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184.1945 Vitamin B12. and handled as a food ingredient; and 184.1950 Vitamin D. that the quantity of the ingredient 184.1973 Beeswax (yellow and white). added to food does not exceed the 184.1976 Candelilla wax. 184.1978 Carnauba wax. amount reasonably required to accom- 184.1979 Whey. plish the intended physical, nutri- 184.1979a Reduced lactose whey. tional, or other technical effect in 184.1979b Reduced minerals whey. food. 184.1979c Whey protein concentrate. (1) If the ingredient is affirmed as 184.1983 Bakers yeast extract. GRAS with no limitations on its condi- 184.1984 Zein. tions of use other than current good 184.1985 Aminopeptidase enzyme prepara- manufacturing practice, it shall be re- tion derived from lactococcus lactis. garded as GRAS if its conditions of use AUTHORITY: 21 U.S.C. 321, 342, 348, 371. are consistent with the requirements of SOURCE: 42 FR 14653, Mar 15, 1977, unless paragraph (b), (c), and (d) of this sec- otherwise noted. tion. When the Food and Drug Admin- EDITORIAL NOTE: Nomenclature changes to istration (FDA) determines that it is part 184 appear at 66 FR 56035, Nov. 6, 2001, 66 appropriate, the agency will describe FR 66742, Dec. 27, 2001, 68 FR 15355, Mar. 31, one or more current good manufac- 2003, and 69 FR 13717, Mar. 24, 2004. turing practice conditions of use in the regulation that affirms the GRAS sta- Subpart A—General Provisions tus of the ingredient. For example, when the safety of an ingredient has § 184.1 Substances added directly to been evaluated on the basis of limited human food affirmed as generally conditions of use, the agency will de- recognized as safe (GRAS). scribe in the regulation that affirms (a) The direct human food ingredi- the GRAS status of the ingredient, one ents listed in this part have been re- or more of these limited conditions of viewed by the Food and Drug Adminis- use, which may include the category of tration and determined to be generally food(s), the technical effect(s) or func- recognized as safe (GRAS) for the pur- tional use(s) of the ingredient, and the poses and under the conditions pre- level(s) of use. If the ingredient is used scribed. The regulations in this part under conditions that are significantly shall sufficiently describe each ingre- different from those described in the dient to identify the characteristics of regulation, that use of the ingredient the ingredient that has been affirmed may not be GRAS. In such a case, a as GRAS and to differentiate it from manufacturer may not rely on the reg- other possible versions of the ingre- ulation as authorizing that use but dient that have not been affirmed as shall independently establish that that GRAS. Ingredients affirmed as GRAS use is GRAS or shall use the ingredient in this part are also GRAS as indirect in accordance with a food additive reg- human food ingredients, subject to any ulation. Persons seeking FDA approval limitations prescribed in parts 174, 175, of an independent determination that a 176, 177, 178 or § 179.45 of this chapter or use of an ingredient is GRAS may sub- in part 186 of this chapter. The purity mit a GRAS petition in accordance specifications in this part do not apply with § 170.35 of this chapter. when the ingredient is used in indirect (2) If the ingredient is affirmed as applications. However, when used in in- GRAS with specific limitation(s), it direct applications, the ingredient shall be used in food only within such must be of a purity suitable for its in- limitation(s), including the category of tended use in accordance with food(s), the functional use(s) of the in- § 170.30(h)(1) of this chapter. gredient, and the level(s) of use. Any (b) Any ingredient affirmed as GRAS use of such an ingredient not in full in this part shall be used in accordance compliance with each such established with current good manufacturing prac- limitation shall require a food additive tice. For the purpose of this part, cur- regulation. rent good manufacturing practice in- (3) If the ingredient is affirmed as cludes the requirements that a direct GRAS for a specific use, without a gen- human food ingredient be of appro- eral evaluation of use of the ingredient, priate food grade; that it be prepared other uses may also be GRAS.

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(c) The listing of a food ingredient in food processor independently to deter- this part does not authorize the use of mine that use of the ingredients will be such substance in a manner that may in accordance with any limitations and lead to deception of the consumer or to good manufacturing practice gudelines any other violation of the Federal prescribed. Food, Drug, and Cosmetic Act (the (3) Adequate directions for use to Act). provide a final food product that com- (d) The listing of more than one in- plies with any limitations prescribed gredient to produce the same techno- for the ingredient(s). logical effect does not authorize use of [42 FR 14653, Mar. 15, 1977, as amended at 42 a combination of two or more ingredi- FR 55205, Oct. 14, 1977; 48 FR 48457, 48459, Oct. ents to accomplish the same techno- 19, 1983; 62 FR 15110, Mar. 31, 1997] logical effect in any one food at a combined level greater than the highest Subpart B—Listing of Specific level permitted for one of the ingredi- Substances Affirmed as GRAS ents. (e) If the Commissioner of Food and § 184.1005 Acetic acid. Drugs is aware of any prior sanction (a) Acetic acid (C2H4O2, CAS Reg. No. for use of an ingredient under condi- 64–19–7) is known as ethanoic acid. It tions different from those proposed to occurs naturally in plant and animal be affirmed as GRAS, he will concur- tissues. It is produced by fermentation rently propose a separate regulation of carbohydrates or by organic syn- covering such use of the ingredient thesis. The principal synthetic meth- under part 181 of this chapter. If the ods currently employed are oxidation Commissioner is unaware of any such of acetaldehyde derived from ethylene, applicable prior sanction, the proposed liquid phase oxidation of butane, and regulation will so state and will re- reaction of carbon monoxide with quire any person who intends to assert methanol derived from natural gas. or rely on such sanction to submit (b) The ingredient meets the speci- proof of its existence. Any regulation fications of the Food Chemicals Codex, promulgated pursuant to this section 3d Ed. (1981), p. 8, which is incorporated constitutes a determination that ex- by reference. Copies are available from cluded uses would result in adultera- the National Academy Press, 2101 Con- tion of the food in violation of section stitution Ave. NW., Washington, DC 402 of the Act, and the failure of any 20418, or available for inspection at the person to come forward with proof of Office of the Federal Register, 800 such an applicable prior sanction in re- North Capitol Street, NW., suite 700, sponse to the proposal will constitute a Washington, DC 20408. waiver of the right to assert or rely on (c) The ingredient is used as a curing such sanction at any later time. The and pickling agent as defined in notice will also constitute a proposal § 170.3(o)(5) of this chapter; flavor to establish a regulation under part 181 enhancer as defined in § 170.3(o)(11) of of this chapter, incorporating the same this chapter; flavoring agent and adju- provisions, in the event that such a vant as defined in § 170.3(o)(12) of this regulation is determined to be appro- chapter; pH control agent as defined in priate as a result of submission of proof § 170.3(o)(23) of this chapter; as a sol- of such an applicable prior sanction in vent and vehicle as defined in response to the proposal. § 170.3(o)(27) of this chapter; and as a (f) The label and labeling of the in- boiler water additive complying with gredient and any intermediate mix of § 173.310 of this chapter. the ingredient for use in finished food (d) The ingredient is used in food at shall bear, in addition to the other la- levels not to exceed current good man- beling required by the Act: ufacturing practice in accordance with (1) The name of the ingredient, ex- § 184.1(b)(1). Current good manufac- cept where exempted from such label- turing practice results in a maximum ing in part 101 of this chapter. level as served, of 0.25 percent for (2) A statement of concentration of baked goods as defined in § 170.3(n)(1) of the ingredient in any intermediate this chapter; 0.8 percent for cheeses as mix; or other information to permit a defined in § 170.3(n)(5) of this chapter

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and dairy product analogs as defined in (2) Melting point. Not less than 195 °C § 170.3(n)(10) of this chapter; 0.5 percent and the determination results in de- for chewing gum as defined in composition of aconitic acid. § 170.3(n)(6) of this chapter; 9.0 percent (3) Heavy metals (as Pb). Not more for condiments and relishes as defined than 10 parts per million. in § 170.3(n)(8) of this chapter; 0.5 per- (4) Arsenic (as As). Not more than 3 cent for fats and oils as defined in parts per million. § 170.3(n)(12) of this chapter; 3.0 percent (5) Oxalate. Passes test. for gravies and sauces as defined in (6) Readily carbonizable substances. § 170.3(n)(24) of this chapter; 0.6 percent Passes the test for citric acid of the for meat products as defined in ‘‘Food Chemicals Codex,’’ 4th ed. (1996), § 170.3(n)(29) of this chapter; and 0.15 pp. 102–103, which is incorporated by reference in accordance with 5 U.S.C. percent or less for all other food cat- 552(a) and 1 CFR part 51. The avail- egories. The ingredient may also be ability of this incorporation by ref- used in boiler water additives at levels erence is given in paragraph (b)(1) of not to exceed current good manufac- this section. turing practice. (7) Residue on ignition. Not more than (e) Prior sanctions for this ingredient 0.1 percent as determined by the ‘‘Food different from the uses established in Chemicals Codex,’’ 4th ed. (1996), pp. this section do not exist or have been 102–103, test for citric acid, which is in- waived. corporated by reference in accordance [47 FR 27814, June 25, 1982] with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation § 184.1007 Aconitic acid. by reference is given in paragraph (b)(1) of this section. (a) Aconitic acid (1,2,3- (c) The ingredient is used as a fla- propenetricarboxylic acid (C6H6O6), voring substance and adjuvant as de- CAS Reg. No. 000499–12–7) occurs in the fined in § 170.3(o)(12) of this chapter. leaves and tubers of Aconitum napellus (d) The ingredient is used in food, in L. and other Ranunculaceae. accordance with § 184.1(b)(1), at levels Transaconitic acid can be isolated dur- not to exceed good manufacturing ing sugarcane processing, by precipita- practice. Current good manufacturing tion as the calcium salt from cane practice results in a maximum level, as sugar or molasses. It may be syn- served, of 0.003 percent for baked goods thesized by sulfuric acid dehydration of as defined in § 170.3(n)(1) of this chap- citric acid, but not by the ter, 0.002 percent for alcoholic bev- methanesulfonic acid method. erages as defined in § 170.3(n)(2) of this (b) The ingredient meets the fol- chapter, 0.0015 percent for frozen dairy lowing specifications: products as defined in § 170.3(n)(20) of (1) Assay. Not less than 98.0 percent this chapter, 0.0035 percent for soft of C3H3(COOH)3, using the ‘‘Food candy as defined in § 170.3(n)(38) of this Chemicals Codex,’’ 4th ed. (1996), pp. chapter, and 0.0005 percent or less for 102–103, test for citric acid, which is in- all other food categories. corporated by reference in accordance (e) Prior sanctions for this ingredient with 5 U.S.C. 552(a) and 1 CFR part 51, different from the uses established in and a molecular weight of 174.11. Copies this section do not exist or have been of the material incorporated by ref- waived. erence are available from the National [43 FR 47724, Oct. 17, 1978, as amended at 49 Academy Press, Box 285, 2101 Constitu- FR 5610, Feb. 14, 1984; 64 FR 1759, Jan. 12, tion Ave. NW., Washington, DC 20055 1999] (Internet address http://www.nap.edu), or may be examined at the Center for § 184.1009 Adipic acid.

Food Safety and Applied Nutrition’s (a) Adipic acid (C6H10O4, CAS Reg. Library, Food and Drug Administra- No. 00124–04–9) is also known as 1,4- tion, 5100 Paint Branch Pkwy., College butanedicarboxylic acid or hexane- Park, MD 20740, or at the Office of the dioic acid. It is prepared by nitric acid Federal Register, 800 North Capitol St. oxidation of cyclohexanol or NW., suite 700, Washington, DC. cyclohexanone or a mixture of the two.

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(b) The ingredient meets the speci- section do not exist or have been fications of the Food Chemicals Codex, waived. 3d Ed. (1981), p. 11, which is incor- [47 FR 27810, June 25, 1982] porated by reference (copies are available from the National Academy Press, § 184.1011 Alginic acid. 2101 Constitution Ave., NW., Wash- (a) Alginic acid is a colloidal, hydro- ington, DC 20418, or available for in- philic polysaccharide obtained from spection at the Office of the Federal certain brown algae by alkaline extrac- Register, 800 North Capitol Street, tion. NW., suite 700, Washington, DC 20408), (b) The ingredient meets the speci- and the following additional specifica- fications of the Food Chemicals Codex, tions: 3d Ed. (1981), p. 13, which is incor- (1) The adipic acid is converted to its porated by reference. Copies are avail- corresponding amide. The amide is pu- able from the National Academy Press, rified by recrystallization from water 2101 Constitution Ave. NW., Wash- or aqueous ethanol. The melting range ington, DC 20418, or available for in- of the amide is 219° to 220 °C. spection at the Office of the Federal (2) The adipic acid is converted to its Register, 800 North Capitol Street, corresponding bis-p-p-bromophenacyl NW., suite 700, Washington, DC 20408. ester. The ester is purified by recrys- (c) In accordance with § 184.1(b)(2), tallization from ethanol. The melting the ingredient is used in food only range of the ester is 153° to 154 °C. within the following specific limita- (c) The ingredient is used as a fla- tions: voring agent as defined in § 170.3(o)(12) Maximum level of of this chapter; leavening agent as de- Category of food use in food (as Functional use fined in § 170.3(o)(17) of this chapter; served) and pH control agent as defined in Soup and soup Not to exceed cur- Emulsifier, emulsi- § 170.3(o)(23) of this chapter. mixes, rent good manu- fier salt, (d) The ingredient is used in foods at § 170.3(n) (40) facturing prac- § 170.3(o)(8) of of this chapter. tice. this chapter; for- levels not to exceed current good man- mulation aid, ufacturing practice in accordance with § 170.3(o)(14) of § 184.1(b)(1). Current good manufac- this chapter; sta- turing practice results in maximum bilizer, thickener, § 170.3(o)(28) of levels, as served, of 0.05 percent for this chapter. baked goods as defined in § 170.3(n)(1) of this chapter; 0.005 percent for non- (d) Prior sanctions for this ingredient alcoholic beverages as defined in different from the use established in § 170.3(n)(3) of this chapter; 5.0 percent this section do not exist or have been for condiments and relishes as defined waived. in § 170.3(n)(8) of this chapter; 0.45 per- [47 FR 47375, Oct. 26, 1982] cent for dairy product analogs as defined in § 170.3(n)(10) of this chapter; 0.3 § 184.1012 α-Amylase enzyme prepara- percent for fats and oil as defined in tion from Bacillus § 170.3(n)(12) of this chapter; 0.0004 per- stearothermophilus. cent for frozen dairy desserts as defined (a) a-Amylase enzyme preparation is in § 170.3(n)(20) of this chapter; 0.55 per- obtained from the culture filtrate that cent for gelatin and puddings as de- results from a pure culture fermenta- fined in § 170.3(n)(22) of this chapter; 0.1 tion of a nonpathogenic and percent for gravies as defined in nontoxicogenic strain of Bacillus § 170.3(n)(24) of this chapter; 0.3 percent stearothermophilus. Its characterizing for meat products as defined in enzyme activity is a-amylase (1,4 a-D § 170.3(n)(29) of this chapter; 1.3 percent glucan glucanohydrolase (E.C. 3.2.1.1)). for snack foods as defined in (b) The ingredient meets the general § 170.3(n)(37) of this chapter; and 0.02 and additional requirements for en- percent or less for all other food cat- zyme preparations in the ‘‘Food Chemi- egories. cals Codex,’’ 3d ed. (1981), pp. 107–110, (e) Prior sanctions for adipic acid dif- which is incorporated by reference in ferent from the uses established in this accordance with 5 U.S.C. 552(a) and 1

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CFR part 51. Copies are available from voring agent and adjuvant as defined in the National Academy Press, 2101 Con- § 170.3(o)(12) of this chapter. stitution Ave. NW., Washington, DC (d) The ingredient is used in food at 20418, or may be examined at the Office levels not to exceed good manufac- of Premarket Approval (HFS–200), Cen- turing practice. Current usage results ter for Food Safety and Applied Nutri- in a maximum level of 0.1 percent in tion, Food and Drug Administration, food. (The Food and Drug Administra- 1110 Vermont Ave. NW., suite 1200, tion has not determined whether sig- Washington, DC, or the Office of the nificantly different conditions of use Federal Register, 800 North Capitol St. would be GRAS). NW., suite 700, Washington, DC. (e) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from those uses established in the ingredient is used in food with no this section, or different from that set limitation other than current good forth in part 181 of this chapter, do not manufacturing practices. The affirma- exist or have been waived. tion of this ingredient as GRAS as a di- [42 FR 14653, Mar. 15, 1977, as amended at 49 rect human food ingredient is based FR 5610, Feb. 14, 1984] upon the following current good manufacturing practice conditions of use: § 184.1024 Bromelain. (1) The ingredient is used as an en- (a) Bromelain (CAS Reg. No. 9001–00– zyme, as defined in § 170.3(o)(9) of this 7) is an enzyme preparation derived chapter, in the hydrolysis of edible from the pineapples Ananas comosus starch to produce maltodextrins and and A. bracteatus L. It is a white to nutritive carbohydrate sweeteners. light tan amorphous powder. Its char- (2) The ingredient is used at levels acterizing enzyme activity is that of a not to exceed current good manufac- peptide hydrolase (EC 3.4.22.32). turing practices. (b) The ingredient meets the general [60 FR 55789, Nov. 3, 1995] requirements and additional requirements for enzyme preparations in the § 184.1021 Benzoic acid. Food Chemicals Codex, 3d ed. (1981), p. (a) Benzoic acid is the chemical 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 benzenecarboxylic acid (C7H6O2), occurring in nature in free and combined CFR part 51. Copies are available from forms. Among the foods in which ben- the National Academy Press, 2101 Con- zoic acid occurs naturally are cran- stitution Ave. NW., Washington, DC, or berries, prunes, plums, cinnamon, ripe may be examined at the Office of Pre- cloves, and most berries. Benzoic acid market Approval (HFS–200), Food and is manufactured by treating molten Drug Administration, 5100 Paint phthalic anhydride with steam in the Branch Pkwy., College Park, MD 20740, presence of a zinc oxide catalyst, by and the Office of the Federal Register, the hydrolysis of benzotrichloride, or 800 North Capitol St. NW., suite 700, by the oxidation of toluene with nitric Washington, DC. acid or sodium bichromate or with air (c) In accordance with § 184.1(b)(1), in the presence of a transition metal the ingredient is used in food with no salt catalyst. limitation other than current good (b) The ingredient meets the speci- manufacturing practice. The affirma- fications of the ‘‘Food Chemicals tion of this ingredient as GRAS as a di- Codex,’’ 3d Ed. (1981), p. 35, which is in- rect food ingredient is based upon the corporated by reference. Copies may be following current good manufacturing obtained from the National Academy practice conditions of use: Press, 2101 Constitution Ave. NW., (1) The ingredient is used as an en- Washington, DC 20418, or may be exam- zyme as defined in § 170.3(o)(9) of this ined at the Office of the Federal Reg- chapter to hydrolyze proteins or ister, 800 North Capitol Street, NW., polypeptides. suite 700, Washington, DC 20408. (2) The ingredient is used in food at levels not to exceed current good man- (c) The ingredient is used as an anti- ufacturing practice. microbial agent as defined in § 170.3(o)(2) of this chapter, and as a fla- [60 FR 32910, June 26, 1995]

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§ 184.1025 Caprylic acid. the culture filtrate resulting from a pure culture fermentation of a non- (a) Caprylic acid [CH (CH ) COOH, 3 2 6 pathogenic strain of B. licheniformis. CAS Reg. No. 124–07–2] is the chemical (b) The ingredient meets the speci- name for octanoic acid. It is considered fications of the Food Chemicals Codex, to be a short or medium chain fatty 3d Ed. (1981), p. 107, which is incor- acid. It occurs normally in various porated by reference. Copies are avail- foods and is commercially prepared by able from the National Academy Press, oxidation of n-octanol or by fermenta- 2101 Constitution Ave. NW., Wash- tion and fractional distillation of the ington, DC 20418, or available for in- volatile fatty acids present in coconut spection at the Office of the Federal oil. Register, 800 North Capitol Street, (b) The ingredient meets the speci- NW., suite 700, Washington, DC 20408. fications of the ‘‘Food Chemicals (c) In accordance with § 184.1(b)(1), Codex,’’ 3d Ed. (1981), p. 207, which is in- the ingredient is used in food with no corporated by reference. Copies may be limitation other than current good obtained from the National Academy manufacturing practice. The affirma- Press, 2101 Constitution Ave. NW., tion of this ingredient as generally rec- Washington, DC 20418, or may be exam- ognized as safe as a direct human food ined at the Office of the Federal Reg- ingredient is based upon the following ister, 800 North Capitol Street, NW., current good manufacturing practice suite 700, Washington, DC 20408. conditions of use: (c) The ingredient is used as a fla- (1) The ingredient is used as an en- voring agent and adjuvant as defined in zyme, as defined in § 170.3(o)(9) of this § 170.3(o)(12) of this chapter. chapter, to hydrolyze proteins or car- (d) The ingredient is used in foods in bohydrates. accordance with § 184.1(b)(1), at levels (2) The ingredient is used in the fol- not to exceed good manufacturing lowing foods at levels not to exceed practice. Current good manufacturing current good manufacturing practice: practices result in maximum levels, as alcoholic beverages, as defined in served, of: 0.013 percent for baked goods § 170.3(n)(2) of this chapter, candy, nu- as defined in § 170.3(n)(1) of this chap- tritive sweeteners, and protein ter; 0.04 percent for cheeses as defined hydrolyzates. in § 170.3(n)(5) of this chapter; 0.005 per- [48 FR 240, Jan. 4, 1983] cent for fats and oils as defined in § 170.3(n)(12) of this chapter, for frozen § 184.1033 Citric acid. dairy desserts as defined in § 170.3(n)(20) (a) Citric acid (C H O , CAS Reg. No. of this chapter, for gelatins and pud- 6 8 7 77–92–9) is the compound 2-hydroxy- dings as defined in § 170.3(n)(22) of this 1,2,3-propanetricarboxylic acid. It is a chapter, for meat products as defined naturally occurring constituent of in § 170.3(n)(29) of this chapter, and for plant and animal tissues. It occurs as soft candy as defined in § 170.3(n)(38) of colorless crystals or a white powder this chapter; 0.016 percent for snack and may be anhydrous or contain one foods as defined in § 170.3(n)(37) of this mole of water per mole of citric acid. chapter; and 0.001 percent or less for all Citric acid may be produced by recov- other food categories. ery from sources such as lemon or pine- (e) Prior sanctions for this ingredient apple juice; by mycological fermenta- different from the uses established in tion using Candida spp., described in this section do not exist or have been §§ 173.160 and 173.165 of this chapter; and waived. by the solvent extraction process de- [43 FR 19843, May 9, 1978, as amended at 49 scribed in § 173.280 of this chapter for FR 5611, Feb. 14, 1984] the recovery of citric acid from Asper- gillus niger fermentation liquor. § 184.1027 Mixed carbohydrase and (b) The ingredient meets the speci- protease enzyme product. fications of the Food Chemicals Codex, (a) Mixed carbohydrase and protease 3d ed. (1981), pp. 86–87, and its third sup- enzyme product is an enzyme prepara- plement (March 1992), pp. 107–108, which tion that includes carbohydrase and are incorporated by reference in ac- protease activity. It is obtained from cordance with 5 U.S.C. 552(a) and 1 CFR

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part 51. Copies are available from the § 184.1061 Lactic acid. National Academy Press, 2101 Constitu- (a) Lactic acid (C H O , CAS Reg. tion Ave. NW., Washington, DC 20418, 3 6 3 Nos.: mixture, 598–82–3; -isomer, 79– and the Center for Food Safety and Ap- DL L plied Nutrition (HFS–200), 5100 Paint 33–4; D-isomer, 10326–41–7), the chemical Branch Pkwy., College Park, MD 20740, 2-hydroxypropanoic acid, occurs natu- or may be examined at the Office of the rally in several foods. It is produced Federal Register, 800 North Capitol St. commercially either by fermentation NW., suite 700, Washington, DC. of carbohydrates such as glucose, su- (c) In accordance with § 184.1(b)(1), crose, or lactose, or by a procedure in- the ingredient is used in food with no volving formation of lactonitrile from limitations other than current good acetaldehyde and hydrogen cyanide manufacturing practice. and subsequent hydrolysis to lactic (d) Prior sanctions for this ingredient acid. different from the uses established in (b) The ingredient meets the speci- this section do not exist or have been fications of the Food Chemicals Codex, waived. 3d Ed. (1981), p. 159, which is incorporated by reference. Copies are avail- [59 FR 63895, Dec. 12, 1994] able from the National Academy Press, 2101 Constitution Avenue, NW., Wash- § 184.1034 Catalase (bovine liver). ington, DC 20418, or available for in- (a) Catalase (bovine liver) (CAS Reg. spection at the Office of the Federal No. 9001–05–2) is an enzyme preparation Register, 800 North Capitol Street, obtained from extracts of bovine liver. NW., suite 700, Washington, DC 20408. It is a partially purified liquid or pow- (c) In accordance with § 184.1(b)(1), der. Its characterizing enzyme activity the ingredient is used in food with no is catalase (EC 1.11.1.6). limitation other than current good (b) The ingredient meets the general manufacturing practice. The affirma- requirements and additional require- tion of this ingredient as generally rec- ments for enzyme preparations in the ognized as safe (GRAS) as a direct Food Chemicals Codex, 3d ed. (1981), p. human food ingredient is based upon 110, which is incorporated by reference the following current good manufac- in accordance with 5 U.S.C. 552(a) and 1 turing practice conditions of use: CFR part 51. Copies are available from (1) The ingredient is used as an anti- the National Academy Press, 2101 Con- microbial agent as defined in stitution Ave., NW., Washington, DC § 170.3(o)(2) of this chapter; a curing and 20418, or may be examined at the Office pickling agent as defined in § 170.3(o)(5) of Premarket Approval (HFS–200), Food of this chapter; a flavor enhancer as de- and Drug Administration, 5100 Paint fined in § 170.3(o)(11) of this chapter; a Branch Pkwy., College Park, MD 20740, flavoring agent and adjuvant as defined and the Office of the Federal Register, in § 170.3(o)(12) of this chapter; a pH 800 North Capitol St. NW., suite 700, control agent as defined in § 170.3(o)(23) Washington, DC. of this chapter; and a solvent and vehi- (c) In accordance with § 184.1(b)(1), cle as defined in § 170.3(o)(27) of this the ingredient is used in food with no chapter. limitation other than current good (2) The ingredient is used in food, ex- manufacturing practice. The affirma- cept in infant foods and infant for- tion of this ingredient as GRAS as a di- mulas, at levels not to exceed current rect food ingredient is based upon the good manufacturing practice. following current good manufacturing practice conditions of use: (d) Prior sanctions for this ingredient (1) The ingredient is used as an en- different from the uses established in zyme as defined in § 170.3(o)(9) of this this section do not exist or have been chapter to decompose hydrogen per- waived. oxide. [49 FR 35367, Sept. 7, 1984] (2) The ingredient is used in food at levels not to exceed current good man- § 184.1063 Enzyme-modified lecithin. ufacturing practice. (a) Enzyme-modified lecithin is pre- [60 FR 32910, June 26, 1995] pared by treating lecithin with either

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phospholipase A2 (EC 3.1.1.4) or pan- ingredient is based upon the following creatin. current good manufacturing practice (b) The ingredient meets the speci- conditions of use: fications in paragraphs (b)(1) through (1) The ingredient is used as an emul- (b)(8) of this section. Unless otherwise sifier as defined in § 170.3(o)(8) of this noted, compliance with the specifica- chapter. tions listed below is determined ac- (2) The ingredient is used at levels cording to the methods set forth for not to exceed current good manufac- lecithin in the Food Chemicals Codex, turing practice. 4th ed. (1996), pp. 220–221, which are incorporated by reference in accordance [61 FR 45889, Aug. 30, 1996] with 5 U.S.C. 552(a) and 1 CFR part 51. § 184.1065 Linoleic acid. Copies are available from the National Academy Press, 2101 Constitution Ave. (a) Linoleic acid ((Z, Z)–9, 12-octadec- NW., Washington DC 20418, or may be adienoic acid (C17H31COOH) (CAS Reg. examined at the Center for Food Safety No. 60–33–3)), a straight chain unsatu- and Applied Nutrition’s Library, 5100 rated fatty acid with a molecular Paint Branch Pkwy., College Park, MD weight of 280.5, is a colorless oil at 20740, or at the Office of the Federal room temperature. Linoleic acid may Register, 800 North Capitol St. NW., be prepared from edible fats and oils by suite 700, Washington, DC. various methods including hydrolysis (1) Acetone-insoluble matter and saponification, the Twitchell (phosphatides), not less than 50.0 per- method, low pressure splitting with cent. catalyst, continuous high pressure (2) Acid value, not more than 40. counter current splitting, and medium (3) Lead, not more than 1.0 part per pressure autoclave splitting with cata- million, as determined by atomic ab- lyst. sorption spectroscopy. (b) FDA is developing food-grade (4) Heavy metals (as Pb), not more specifications for linoleic acid in co- than 20 parts per million. operation with the National Academy (5) Hexane-insoluble matter, not of Sciences. In the interim, this ingre- more than 0.3 percent. dient must be of a purity suitable for (6) Peroxide value, not more than 20. its intended use. The ingredient must (7) Water, not more than 4.0 percent. also meet the specifications in (8) Lysolecithin, 50 to 80 mole percent § 172.860(b) of this chapter. of total phosphatides as determined by (c) In accordance with § 184.1(b)(1), ‘‘Determination of Lysolecithin Con- the ingredient is used in food with no tent of Enzyme-Modified Lecithin: limitation other than current good Method I,’’ dated 1985, which is incor- manufacturing practice. The affirma- porated by reference in accordance tion of this ingredient as generally rec- with 5 U.S.C. 552(a) and 1 CFR part 51. ognized as safe (GRAS) as a direct Copies are available from the Division human food ingredient is based upon of Petition Control, Center for Food the following current good manufac- Safety and Applied Nutrition (HFS– turing practice conditions of use: 215), Food and Drug Administration, (1) The ingredient is used as a fla- 5100 Paint Branch Pkwy., College Park, voring agent and adjuvant as defined in MD 20740, or may be examined at the § 170.3(o)(12) of this chapter and as a nu- Center for Food Safety and Applied Nu- trient supplement as defined in trition’s Library, 5100 Paint Branch § 170.3(o)(20) of this chapter. Pkwy., College Park, MD 20740, or at (2) The ingredient is used in foods at the Office of the Federal Register, 800 levels not to exceed current good man- North Capitol St. NW., suite 700, Wash- ufacturing practice. The ingredient ington, DC. may be used in infant formula in ac- (c) In accordance with § 184.1(b)(1), cordance with section 412(g) of the Fed- the ingredient is used in food with no eral Food, Drug, and Cosmetic Act (the limitation other than current good act) or with regulations promulgated manufacturing practice. The affirma- under section 412(a)(2) of the act. tion of this ingredient as generally rec- (d) Prior sanctions for this ingredient ognized as safe as a direct human food different from the uses established in

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this section do not exist or have been § 184.1077 Potassium acid tartrate. waived. (a) Potassium acid tartrate (C4H5KO6, [49 FR 48534, Dec. 13, 1984] CAS Reg. No. 868–14–4) is the potassium acid salt of L¥(+)¥tartaric acid and is § 184.1069 Malic acid. also called potassium bitartrate or (a) Malic acid (C4H6O5, CAS Reg. No. cream of tartar. It occurs as colorless of L-form 97–67–6, CAS Reg. No. of DL- or slightly opaque crystals or as a form 617–48–1) is the common name for white, crystalline powder. It has a 1-hydroxy-1, 2-ethanedicarboxylic acid. pleasant, acid taste. It is obtained as a L (+) malic acid, referred to as L-malic byproduct of wine manufacture. acid, occurs naturally in various foods. (b) The ingredient meets the speci- Racemic DL-malic acid does not occur fications of the Food Chemicals Codex, naturally. It is made commercially by 3d Ed. (1981), P. 238, which is incor- hydration of fumaric acid or maleic porated by reference. Copies are avail- acid. able from the National Academy Press, (b) The ingredient meets the speci- 2101 Constitution Ave. NW., Wash- fications of the ‘‘Food Chemicals ington, DC 20418, or available for in- Codex,’’ 3d Ed. (1981), pp. 183–184, which spection at the Office of the Federal is incorporated by reference. Copies Register, 800 North Capitol Street, may be obtained from the National NW., suite 700, Washington, DC 20408. Academy Press, 2101 Constitution Ave. (c) In accordance with § 184.1(b)(1), NW., Washington, DC 20418, or may be the ingredient is used in food with no examined at the Office of the Federal limitation other than current good Register, 800 North Capitol Street, manufacturing practice. The affirma- NW., suite 700, Washington, DC 20408. tion of this ingredient as generally rec- (c) The ingredients are used as a fla- ognized as safe (GRAS) as a direct vor enhancer as defined in § 170.3(o)(11) human food ingredient is based upon of this chapter, flavoring agent and ad- the following current good manufac- juvant as defined in § 170.3(o)(12) of this turing practice conditions of use: chapter, and pH control agent as de- (1) The ingredient is used as an fined in § 170.3(o)(23) of this chapter. anticaking agent as defined in (d) The ingredients are used in food, § 170.3(o)(1) of this chapter; an anti- except baby food, at levels not to ex- microbial agent as defined in ceed good manufacturing practice in § 170.3(o)(2) of this chapter; a formula- accordance with § 184.1(b)(1). Current tion aid as defined in § 170.3(o)(14) of good manufacturing practice results in this chapter; a humectant as defined in a maximum level, as served, of 3.4 per- § 170.3(o)(16) of this chapter; a leavening cent for nonalcoholic beverages as de- agent as defined in § 170.3(o)(17) of this fined in § 170.3(n)(3) of this chapter; 3.0 chapter; A pH control agent as defined percent for chewing gum as defined in in § 170.3(o)(23) of this chapter; a proc- § 170.3(n)(6) of this chapter; 0.8 percent essing aid as defined in § 170.3(o)(24) of for gelatins, puddings, and fillings as this chapter; a stabilizer and thickener defined in § 170.3(n)(22) of this chapter; as defined in § 170.3(o)(28) of this chap- 6.9 percent for hard candy as defined in ter; and a surface-active agent as de- § 170.3(n)(25) of this chapter; 2.6 percent fined in § 170.3(o)(29) of this chapter. for jams and jellies as defined in (2) The ingredient is used in the fol- § 170.3(n)(28) of this chapter; 3.5 percent lowing foods at levels not to exceed for processed fruits and fruit juices as current good manufacturing practice: defined in § 170.3(n)(35) of this chapter; baked goods as defined in § 170.3(n)(1) of 3.0 percent for soft candy as defined in this chapter; confections and frostings § 170.3(n)(38) of this chapter; and 0.7 per- as defined in § 170.3(n)(9) of this chap- cent for all other food categories. ter; gelatins and puddings as defined in (e) Prior sanctions for malic acid dif- § 170.3(n)(22) of this chapter; hard candy ferent from the uses established in this as defined in § 170.3(n)(25) of this chap- section do not exist or have been ter; jams and jellies as defined in waived. § 170.3(n)(28) of this chapter; and soft [44 FR 20656, Apr. 6, 1979, as amended at 49 candy as defined in § 170.3(n)(38) of this FR 5611, Feb. 14, 1984] chapter.

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(d) Prior sanctions for this ingredient (b) The ingredient meets the speci- different from the uses established in fications of the Food Chemicals Codex, this section do not exist or have been 3d Ed. (1981), p. 313, which is incor- waived. porated by reference, and the require- [48 FR 52446, Nov. 18, 1983] ments of § 172.860(b)(2) of this chapter. Copies of the Food Chemicals Codex § 184.1081 Propionic acid. are available from the National Acad- emy Press, 2101 Constitution Ave. NW., (a) Propionic acid (C3H6O2, CAS Reg. No. 79–09–4) is an oily liquid having a Washington, DC 20418, or available for slightly pungent, rancid odor. It is inspection at the Office of the Federal manufactured by chemical synthesis or Register, 800 North Capitol Street, by bacterial fermentation. NW., suite 700, Washington, DC 20408. (b) The ingredient meets the speci- (c) In accordance with § 184.1(b)(1), fications of the Food Chemicals Codex, the ingredient is used in food with no 3d Ed. (1981), p. 254, which is incor- limitation other than current good porated by reference. Copies are avail- manufacturing practice. The affirma- able from the National Academy Press, tion of this ingredient as generally rec- 2101 Constitution Ave. NW., Wash- ognized as safe (GRAS) as a direct ington, DC 20418, or available for in- human food ingredient is based upon spection at the Office of the Federal the following current good manufac- Register, 800 North Capitol Street, turing practice conditions of use: NW., suite 700, Washington, DC 20408. (1) The ingredient is used as a fla- (c) In accordance with § 184.1(b)(1), voring agent and adjuvant as defined in the ingredient is used in food with no § 170.3(o)(12) of this chapter. limitation other than current good (2) The ingredient is used in foods at manufacturing practice. The affirma- levels not to exceed current good man- tion of this ingredient as generally rec- ufacturing practice. ognized as safe (GRAS) as a direct (d) Prior sanctions for this ingredient human food ingredient is based upon different from the uses established in the following current good manufac- this section do not exist or have been turing practice conditions of use: waived. (1) The ingredient is used as an antimicrobial agent as defined in [48 FR 52445, Nov. 18, 1983, as amended at 50 § 170.3(o)(2) of this chapter and a fla- FR 49536, Dec. 3, 1985] voring agent as defined in § 170.3(o)(12) of this chapter. § 184.1091 Succinic acid.

(2) The ingredient is used in foods at (a) Succinic acid (C4H6O4, CAS Reg. levels not to exceed current good man- No. 110–15–6), also referred to as amber ufacturing practice. acid and ethylenesuccinic acid, is the (d) Prior sanctions for this ingredient chemical 1,4-butanedioic acid. It is different from the uses established in commercially prepared by hydro- this section do not exist or have been genation of maleic or fumaric acid. It waived. can also be produced by aqueous alkali [49 FR 13141, Apr. 3, 1984] or acid hydrolysis of succinonitrile. (b) The ingredient meets the speci- § 184.1090 Stearic acid. fications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), pp. 314–315, which (a) Stearic acid (C16H36O2, CAS Reg. No. 57–11–4) is a white to yellowish is incorporated by reference. Copies white solid. It occurs naturally as a may be obtained from the National glyceride in tallow and other animal or Academy Press, 2101 Constitution Ave. vegetable fats and oils and is a prin- NW., Washington, DC 20418, or may be cipal constituent of most commercially examined at the Office of the Federal hydrogenated fats. It is produced com- Register, 800 North Capitol Street, mercially from hydrolyzed tallow de- NW., suite 700, Washington, DC 20408. rived from edible sources or from (c) The ingredient is used as a flavor hydrolyzed, completely hydrogenated enhancer as defined in § 170.3(o)(11) of vegetable oil derived from edible this chapter and pH control agent as sources. defined in § 170.3(o)(23) of this chapter.

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(d) The ingredient is used in food at § 170.3(n)(2) of this chapter and 0.0003 levels not to exceed good manufac- percent for cheeses as defined in turing practice in accordance with § 170.3(n)(5) of this chapter. § 184.1(b)(1). Current good manufac- (e) Prior sanctions for this ingredient turing practice results in a maximum different from the uses established in level, as served, of 0.084 percent in con- this section do not exist or have been diments and relishes as defined in waived. § 170.3(n)(8) of this chapter and 0.0061 percent in meat products as defined in [45 FR 6085, Jan. 25, 1980, as amended at 49 § 170.3(n)(29) of this chapter. FR 5611, Feb. 14, 1984] (e) Prior sanctions for this ingredient different from the uses established in § 184.1097 Tannic acid. this section do not exist or have been (a) Tannic acid (CAS Reg. No. 1401– waived. 55–4), or hydrolyzable gallotannin, is a complex polyphenolic organic struc- [44 FR 20657, Apr. 6, 1979, as amended at 49 FR 5611, Feb. 14, 1984] ture that yields gallic acid and either glucose or quinic acid as hydrolysis § 184.1095 Sulfuric acid. products. It is a yellowish-white to light brown substance in the form of an (a) Sulfuric acid (H2SO4, CAS Reg. No. 7664–93–9), also known as oil of vit- amorphous, bulky powder, glistening riol, is a clear, colorless, oily liquid. It scales, or spongy masses. It is also is prepared by reacting sulfur dioxide ordorless, or has a faint characteristic (SO ) with oxygen and mixing the re- odor, and has an astringent taste. Tan- 2 nic acid is obtained by solvent extrac- sultant sulfur trioxide (SO3) with water, or by reacting nitric oxide (NO) tion of nutgalls or excrescences that with sulfur dioxide and water. form on the young twigs of Quercus (b) The ingredient meets the speci- infectoria Oliver and related species of fications of the ‘‘Food Chemicals Quercus. Tannic acid is also obtained Codex,’’ 3d Ed. (1981), pp. 317–318, which by solvent extraction of the seed pods is incorporated by reference. Copies of Tara (Caesalpinia spinosa) or the may be obtained from the National nutgalls of various sumac species, in- Academy Press, 2101 Constitution Ave. cluding Rhus semialata, R. coriaria, R. NW., Washington, DC 20418, or may be galabra, and R. typhia. examined at the Office of the Federal (b) The ingredient meets the speci- Register, 800 North Capitol Street, fications of the Food Chemicals Codex, NW., suite 700, Washington, DC 20408. 3d Ed. (1981), p. 319, which is incor- (c) The ingredient is used as a pH porated by reference. Copies are avail- control agent as defined in § 170.3(o)(23) able from the National Academy Press, of this chapter and processing aid as 2101 Constitution Ave. NW., Wash- defined in § 170.3(o)(24) of this chapter. ington, DC 20418, or available for in- (d) The ingredient is used in food at spection at the Office of the Federal levels not to exceed good manufac- Register, 800 North Capitol Street, turing practice in accordance with NW., suite 700, Washington, DC 20408. § 184.1(b)(1). Current good manufac- (c)(1) In accordance with § 184.1(b)(2), turing practice results in a maximum the ingredient is used in food only level, as served, of 0.014 percent for al- within the following specific limita- coholic beverages as defined in tions:

Maximum level of use Category of food in food (as Functional use served) (percent)

Baked goods and baking mixes, § 170.3(n)(1) of this 0.01 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter. chapter. Alcoholic beverages, § 170.3(n)(2) of this chapter ...... 0 .015 Flavor enhancer, § 170.3(o)(11) of this chapter; flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; processing aid, § 170.3(o)(24) of this chapter. Nonalcoholic beverages and beverage bases, 0 .005 Flavoring agent and adjuvant, § 170.3(o)(12) of this § 170.3(n)(3) of this chapter and for gelatins, pud- chapter; pH control agent, § 170.3(o)(23) of this dings, and fillings, § 170.3(n)(22) of this chapter. chpater.

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Maximum level of use Category of food in food (as Functional use served) (percent)

Frozen dairy desserts and mixes, § 170.3(n)(20) of this 0 .04 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter and for soft candy, § 170.3(n)(38) of this chapter. chapter. Hard candy and cough drops, §170.3(n)(25) of this 0 .013 Do. chapter. Meat products, § 170.3(n)(29) of this chapter ...... 0.001 Do.

(2) Tannic acid may be used in ren- chapter; and a pH control agent as de- dered animal fat in accordance with 9 fined in § 170.3(o)(23) of this chapter. CFR 318.7. (2) The ingredient is used in foods at (d) Prior sanctions for this ingredient levels not to exceed current good man- different from the uses established in ufacturing practice. this section do not exist or have been (d) Prior sanctions for this ingredient waived. different from the uses established in [50 FR 21043, May 22, 1985] this section do not exist or have been waived. § 184.1099 Tartaric acid. [48 FR 52447, Nov. 18, 1983, as amended at 50 (a) Food grade tartaric acid (C4H6O6, FR 49536, Dec. 3, 1985] CAS Reg. No. 87–69–4) has the L con- figuration. The L form of tartaric acid § 184.1101 Diacetyl tartaric acid esters is dextrorotatory in solution and is of mono- and diglycerides. also known as L¥(+)¥tartaric acid. (a) Diacetyl tartaric acid esters of Tartaric acid occurs as colorless or mono- and diglycerides, also know as translucent crystals or as a white, DATEM, are composed of mixed esters crystalline powder. It is odorless and of glycerin in which one or more of the has an acid taste. It is obtained as a hydroxyl groups of glycerin has been byproduct of wine manufacture. esterified by diacetyl tartaric acid and (b) The ingredient meets the speci- by fatty acids. The ingredient is pre- fications of the Food Chemicals Codex, pared by the reaction of diacetyl tar- 3d Ed. (1981), P. 320, which is incor- taric anhydride with mono- and porated by reference. Copies are avail- diglycerides that are derived from edi- able from the National Academy Press, ble sources. 2101 Constitution Ave. NW., Wash- (b) The ingredient meets the speci- ington, DC 20418, or available for in- fications of the Food Chemicals Codex, spection at the Office of the Federal 3d. Ed. (1981), pp. 98–99, which is incor- Register, 800 North Capitol Street, porated by reference in accordance NW., suite 700, Washington, DC 20408. with 5 U.S.C. 552(a). Copies are avail- (c) In accordance with § 184.1(b)(1), able from the National Academy Press, the ingredient is used in food with no limitation other than current good 2101 Constitution Avenue NW., Wash- manufacturing practice. The affirma- ington, DC 20418, or available for in- tion of this ingredient as generally rec- spection at the Office of the Federal ognized as safe (GRAS) as a direct Register, 800 North Capitol Street, human food ingredient is based upon NW., suite 700, Washington, DC 20005. the following current good manufac- (c) In accordance with § 184.1(b)(1), turing practice conditions of use: the ingredient is used in food with no (1) The ingredient is used as a firm- limitation other than current good ing agent as defined in § 170.3(o)(10) of manufacturing practice. The affirma- this chapter; a flavor enhancer as de- tion of this ingredient as generally rec- fined in § 170.3(o)(11) of this chapter; a ognized as safe (GRAS) as a direct flavoring agent as defined in human food ingredient is based upon § 170.3(o)(12) of this chapter; a humec- the following current good manufac- tant as defined in § 170.3(o)(16) of this turing practice conditions of use:

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(1) The ingredient is used in food as ingredient diacetyl tartaric acid esters an emulsifier and emulsifier salt as de- of mono- and diglycerides. fined in § 170.3(o)(8) of this chapter and [54 FR 7403, Feb. 21, 1989, as amended at 54 a flavoring agent and adjuvant as de- FR 13168, Mar. 31, 1989; 54 FR 18382, Apr. 28, fined in § 170.3(o)(12) of this chapter. 1989; 60 FR 15872, Mar. 28, 1995] (2) The ingredient is used in the following foods at levels not to exceed § 184.1115 Agar-agar. current good manufacturing practice: (a) Agar-agar (CAS Reg. No. PM 9002– baked goods and baking mixes as de- 18–0) is a dried, hydrophyllic, colloidal fined in § 170.3(n)(l) of this chapter; polysaccharide extracted from one of a nonalcoholic beverages as defined in number of related species of red algae § 170.3(n)(3) of this chapter; confections (class Rhodophyceae). and frostings as defined in § 170.3(n)(9) (b) The ingredient meets the speci- of this chapter; dairy product analogs fications of the ‘‘Food Chemicals as defined in § 170.3(n)(10) of this chap- Codex,’’ 3d Ed. (1981), p. 11, which is inter; and fats and oils as defined in corporated by reference. Copies may be § 170.3(n)(12) of this chapter. obtained from the National Academy Press, 2101 Constitution Ave. NW., (d) Prior sanctions for this ingredient Washington, DC 20418, or may be exam- different from the uses established in ined at the Office of the Federal Reg- this section do not exist or have been ister, 800 North Capitol Street, NW., waived. suite 700, Washington, DC 20408. (e) Labeling: The acronym ‘‘DATEM’’ (c) The ingredient is used in food in may be used on food labeling as the al- accordance with § 184.1(b)(2) under the ternate common or usual name for the following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Foods (as served) Percent Functions

Baked goods and baking mixes, § 170.3(n)(1) of this 0.8 Drying agent, § 170.3(o)(7) of this chapter; flavoring agent, chapter. § 170.3(o)(12) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter. Confections and frostings, § 170.3(n)(9) of this chap- 2.0 Flavoring agent, § 170.3(o)(12) of this chapter; stabilizer, ter. thickener, § 170.3(o)(28) of this chapter; surface finisher, § 170.3(o)(30) of this chapter. Soft candy, § 170.3(n)(38) of this chapter ...... 1.2 Stabilizer and thickener, § 170.3(o)(28) of this chapter. All other food categories ...... 25 Flavoring agent, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; humectant, § 170.3(o)(16) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter.

(d) Prior sanctions for this ingredient pinnatifida. They are harvested prin- different from the uses established in cipally in coastal waters of the north- this section do not exist or have been ern Atlantic and Pacific oceans. The waived. material is dried and ground or chopped for use in food. [44 FR 19391, Apr. 3, 1979, as amended at 49 (b) The ingredient meets the speci- FR 5611, Feb. 14, 1984] fications for kelp in the Food Chemi- cals Codex, 3d Ed. (1981), p. 157, which is § 184.1120 Brown algae. incorporated by reference. Copies are (a) Brown algae are seaweeds of the available from the National Academy species Analipus japonicus, Eisenia Press, 2101 Constitution Ave. NW., bicyclis, Hizikia fusiforme, Kjellmaniella Washington, DC 20418, or available for gyrata, Laminaria angustata, Laminaria inspection at the Office of the Federal claustonia, Laminaria digitata, Lam- Register, 800 North Capitol Street, inaria japonica, Laminaria longicruris, NW., suite 700, Washington, DC 20408. Laminaria longissima, Laminaria (c) In accordance with § 184.1(b)(2), ochotensis, Laminaria saccharina, the ingredient is used in food only Macrocystis pyrifera, Petalonia fascia, within the following specific limita- Scytosiphon lomentaria and Undaria tions:

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Maximum level of this section do not exist or have been Category of food use in food (as Functional use served) waived. [47 FR 47376, Oct. 26, 1982] Spices, Not to exceed cur- Flavor enhancer, seasonings, and rent good manu- § 170.3(o)(11) of flavorings, facturing prac- this chapter; fla- § 184.1133 Ammonium alginate. § 170.3(n) (26) tice. vor adjuvant, of this chapter. § 170.3(o)(12) of (a) Ammonium alginate (CAS Reg. this chapter. No. 9005–34–9) is the ammonium salt of alginic acid, a natural polyuronide con- (d) Prior sanctions for this ingredient stituent of certain brown algae. Ammo- different from the use established in nium alginate is prepared by the neu- this section do not exist or have been tralization of purified alginic acid with waived. appropriate pH control agents. [47 FR 47376, Oct. 26, 1982] (b) The ingredient meets the specifications of the Food Chemicals Codex, § 184.1121 Red algae. 3d Ed. (1981), p. 18, which is incorporated by reference. Copies are avail- (a) Red algae are seaweeds of the spe- able from the National Academy Press, cies Gloiopeltis furcata, Porphyra 2101 Constitution Ave. NW., Wash- crispata, Porphyra deutata, Porphyra ington, DC 20418, or available for in- perforata, Porphyra suborbiculata, spection at the Office of the Federal Porphyra tenera and Rhodymenia Register, 800 North Capitol Street, palmata. Porphyra and Rhodymenia are NW., suite 700, Washington, DC 20408. harvested principally along the coasts (c) In accordance with § 184.1(b)(2), of Japan, Korea, China, Taiwan, and the ingredient is used in food only the East and West coasts of the United within the following specific limita- States. Gloiopeltis is harvested prin- tions: cipally in southern Pacific coastal waters. The material is dried and ground Maximum or chopped for use in food. level of use in (b) The ingredient meets the speci- Category of food food (as Functional use served) fications for kelp in the Food Chemi- (percent) cals Codex, 3d Ed. (1981), p. 157, which is incorporated by reference, except that Confections, frostings, 0.4 Stabilizer, thickener, the loss on drying is not more than 20 § 170.3(n)(9) of this § 170.3(o)(28) of this chapter. chapter. percent and the maximum allowable Fats and oils, 0.5 Do. level for iodine is 0.05 percent. Copies § 170.3(n)(12) of this are available from the National Acad- chapter. emy Press, 2101 Constitution Ave. NW., Gelatins, puddings, 0.5 Do. § 170.3(n)(22) of this Washington, DC 20418, or available for chapter. inspection at the Office of the Federal Gravies and sauces, 0.4 Do. Register, 800 North Capitol Street, § 170.3(n)(24) of this NW., suite 700, Washington, DC 20408. chapter. Jams and jellies, 0.4 Do. (c) In accordance with § 184.1(b)(2), § 170.3(n)(28) of this the ingredient is used in food only chapter. within the following specific limita- Sweet sauces, 0.5 Do. § 170.3(n)(43) of this tions: chapter. All other food cat- 0.1 Humectant, Maximum level of egories. § 170.3(o)(16) of this Category of food use in food (as Functional use chapter; stabilizer, served) thickener, § 170.3(o)(28) of this Spices, Not to exceed cur- Flavor enhancer, chapter. seasonings, and rent good manu- § 170.3(o)(11) of flavorings, facturing prac- this chapter; fla- § 170.3(n) (26) tice. vor adjuvant, (d) Prior sanctions for ammonium al- of this chapter. § 170.3(o)(12) of ginate different from the uses estab- this chapter. lished in this section do not exist or have been waived. (d) Prior sanctions for this ingredient different from the use established in [47 FR 29950, July 9, 1982]

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§ 184.1135 Ammonium bicarbonate. able from the National Academy Press, 2101 Constitution Ave. NW., Wash- (a) Ammonium bicarbonate ington, DC 20418, or available for in- (NH HCO , CAS Reg. No. 1066–33–7) is 4 3 spection at the Office of the Federal prepared by reacting gaseous carbon di- Register, 800 North Capitol Street, oxide with aqueous ammonia. Crystals NW., suite 700, Washington, DC 20408. of ammonium bicarbonate are precip- (c) In accordance with § 184.1(b)(1), itated from solution and subsequently the ingredient is used in food with no washed and dried. limitation other than current good (b) The ingredient meets the speci- manufacturing practice. The affirma- fications of the Food Chemicals Codex, tion of this ingredient as generally rec- 3d Ed. (1981), p. 19, which is incor- ognized as safe (GRAS) as a direct porated by reference. Copies are avail- human food ingredient is based upon able from the National Academy Press, the following current good manufac- 2101 Constitution Ave. NW., Wash- turing practice conditions of use: ington, DC 20418, or available for in- (1) The ingredient is used as a leav- spection at the Office of the Federal ening agent as defined in § 170.3(o)(17) of Register, 800 North Capitol Street, this chapter and a pH control agent as NW., suite 700, Washington, DC 20408. defined in § 170.3(o)(23) of this chapter. (c) In accordance with § 184.1(b)(1), (2) The ingredient is used in food at the ingredient is used in food with no levels not to exceed current good man- limitation other than current good ufacturing practice. manufacturing practice. The affirma- (d) Prior sanctions for this ingredient tion of this ingredient as generally rec- different from the uses established in ognized as safe (GRAS) as a direct this section do not exist or have been human food ingredient is based upon waived. the following current good manufacturing practice conditions of use: [48 FR 52439, Nov. 18, 1983] (1) The ingredient is used as a dough § 184.1138 Ammonium chloride. strengthener as defined in § 170.3(o)(6) of this chapter; a leavening agent as (a) Ammonium chloride (NH4Cl, CAS defined in § 170.3(o)(17) of this chapter; Reg. No. 12125–02–9) is produced by the a pH control agent as defined in reaction of sodium chloride and an am- § 170.3(o)(23) of this chapter; and a monium salt in solution. The less solu- texturizer as defined in § 170.3(o)(32) of ble sodium salt separates out at ele- this chapter. vated temperatures, and ammonium (2) The ingredient is used in food at chloride is recovered from the filtrate levels not to exceed current good man- on cooling. Alternatively, hydrogen ufacturing practice. chloride formed by the burning of hy- (d) Prior sanctions for this ingredient drogen in chlorine is dissolved in water different from the uses established in and then reacted with gaseous ammo- this section do not exist or have been nia. Ammonium chloride is crystallized waived. from the solution. (b) The ingredient meets the speci- [48 FR 52439, Nov. 18, 1983] fications of the Food Chemicals Codex, 3d Ed. (1981), p. 20, which is incor- § 184.1137 Ammonium carbonate. porated by reference. Copies are avail- (a) Ammonium carbonate ((NH4)2CO3, able from the National Academy Press, CAS Reg. No. 8000–73–5) is a mixture of 2101 Constitution Ave, NW., Wash- ammonium bicarbonate (NH4HCO3) and ington, DC 20418, or available for in- ammonium carbamate (NH2COONH4). spection at the Office of the Federal It is prepared by the sublimation of a Register, 800 North Capitol Street, mixture of ammonium sulfate and cal- NW., suite 700, Washington, DC 20408. cium carbonate and occurs as a white (c) In accordance with § 184.1(b)(1), powder or a hard, white or translucent the ingredient is used in food with no mass. limitation other than current good (b) The ingredient meets the speci- manufacturing practice. The affirma- fications of the Food Chemicals Codex, tion of this ingredient as generally rec- 3d Ed. (1981), p. 19, which is incor- ognized as safe (GRAS) as a direct porated by reference. Copies are avail- human food ingredient is based upon

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the following current good manufac- this section do not exist or have been turing practice conditions of use: waived. (1) The ingredient is used as a dough strengthener as defined in § 170.3(o)(6) [48 FR 52440, Nov. 18, 1983, as amended at 59 FR 14551, Mar. 29, 1994] of this chapter; a flavor enhancer as defined in § 170.3(o)(11) of this chapter; a § 184.1140 Ammonium citrate, dibasic. leavening agent as defined in § 170.3(o)(17) of this chapter; and a proc- (a) Ammonium citrate, dibasic essing aid as defined in § 107.3(o)(24) of ((NH4)2HC6H5O7, CAS Reg. No. 3012–65–5) this chapter. is the diammonium salt of citric acid. (2) The ingredient is used in food at It is prepared by partially neutralizing levels not to exceed current good man- citric acid with ammonia. ufacturing practice. (b) The Food and Drug Administra- (d) Prior sanctions for this ingredient tion, in cooperation with the National different from the uses established in Academy of Sciences, is developing this section do not exist or have been food-grade specifications for ammo- waived. nium citrate, dibasic. In the interim, this ingredient must be of a purity [48 FR 52439, Nov. 18, 1983] suitable for its intended use. § 184.1139 Ammonium hydroxide. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no (a) Ammonium hydroxide (NH OH, 4 limitation other than current good CAS Reg. No. 1336–21–6) is produced by manufacturing practice. The affirma- passing ammonia gas into water. tion of this ingredient as generally rec- (b) The ingredient meets the speci- ognized as safe (GRAS) as a direct fications of the Food Chemicals Codex, 3d Ed. (1981), p. 20, which is incor- human food ingredient is based upon porated by reference. Copies are avail- the following current good manufac- able from the National Academy Press, turing practice conditions of use: 2101 Constitution Ave. NW., Wash- (1) The ingredient is used as a flavor ington, DC 20418, or available for in- enhancer as defined in § 170.3(o)(11) of spection at the Office of the Federal this chapter and as a pH control agent Register, 800 North Capitol Street, as defined in § 170.3(o)(23) of this chap- NW., suite 700, Washington, DC 20408. ter. (c) In accordance with § 184.1(b)(1), (2) The ingredient is used in non- the ingredient is used in food with no alcoholic beverages as defined in limitation other than current good § 170.3(n)(3) of this chapter and in manufacturing practice. The affirma- cheeses as defined in § 170.3(n)(5) of this tion of this ingredient as generally rec- chapter at levels not to exceed current ognized as safe (GRAS) as a direct good manufacturing practice. human food ingredient is based upon (d) Prior sanctions for this ingredient the following current good manufac- different from the uses established in turing practice conditions of use: this section, or different from those set (1) The ingredient is used as a leav- forth in part 181 of this chapter, do not ening agent as defined in § 170.3(o)(17) of exist or have been waived. this chapter; a pH control agent as defined in § 170.3(o)(23) of this chapter; a [59 FR 63896, Dec. 12, 1994] surface-finishing agent as defined in § 184.1141a Ammonium phosphate, § 170.3(o)(30) of this chapter; and as a monobasic. boiler water additive complying with § 173.310 of this chapter. (a) Ammonium phosphate, monobasic (2) The ingredient is used in food at (NH4H2PO4, CAS Reg. No. 7722–76–1) is levels not to exceed current good man- manufactured by reacting ammonia ufacturing practice. The ingredient with phosphoric acid at a pH below 5.8. may also be used as a boiler water ad- (b) The ingredient meets the speci- ditive at levels not to exceed current fications of the Food Chemicals Codex, good manufacturing practice. 3d Ed. (1981), p. 21, which is incor- (d) Prior sanctions for this ingredient porated by reference. Copies are avail- different from the uses established in able from the National Academy Press,

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2101 Constitution Ave. NW., Wash- trol agent as defined in § 170.3(o)(23) of ington, DC 20418, or available for in- this chapter; and a processing aid as spection at the Office of the Federal defined in § 170.3(o)(24) of this chapter. Register, 800 North Capitol Street, (2) The ingredient is used in food at NW., suite 700, Washington, DC 20408. levels not to exceed current good man- (c) In accordance with § 184.1(b)(1), ufacturing practice. the ingredient is used in food with no (d) Prior sanctions for this ingredient limitation other than current good different from the uses established in manufacturing practice. The affirma- this section do not exist or have been tion of this ingredient as generally rec- waived. ognized as safe (GRAS) as a direct human food ingredient is based upon [48 FR 52440, Nov. 18, 1983] the following current good manufacturing practice conditions of use: § 184.1143 Ammonium sulfate. (1) The ingredient is used as a dough (a) Ammonium sulfate ((NH4)2SO4, strengthener as defined in § 170.3(o)(6) CAS Reg. No. 7783–20–2) occurs natu- of this chapter and a pH control agent rally and consists of colorless or white, as defined in § 170.3(o)(23) of this chap- odorless crystals or granules. It is pre- ter. pared by the neutralization of sulfuric (2) The ingredient is used in food at acid with ammonium hydroxide. levels not to exceed current good man- (b) The ingredient meets the speci- ufacturing practice. fications of the ‘‘Food Chemicals (d) Prior sanctions for this ingredient Codex,’’ 3d Ed. (1981), pp. 22–23, which is different from the uses established in incorporated by reference. Copies may this section do not exist or have been be obtained from the National Acad- waived. emy Press, 2101 Constitution Ave. NW., [48 FR 52440, Nov. 18, 1983] Washington, DC 20418, or may be examined at the Office of the Federal Reg- § 184.1141b Ammonium phosphate, di- ister, 800 North Capitol Street, NW., basic. suite 700, Washington, DC 20408. (a) Ammonium phosphate, dibasic (c) The ingredient is used as a dough ((NH4)2HPO4, CAS Reg. No. 7783–28–0) is strengthener as defined in § 170.3(o)(6) manufactured by reacting ammonia of this chapter, firming agent as de- with phosphoric acid at a pH above 5.8. fined in § 170.3(o)(10) of this chapter, (b) The ingredient meets the speci- and processing aid as defined in fications of the Food Chemicals Codex, § 170.3(o)(24) of this chapter. 3d Ed. (1981), p. 21, which is incor- (d) The ingredient is used in food at porated by reference. Copies are avail- levels not to exceed good manufac- able from the National Academy Press, turing practice in accordance with 2101 Constitution Ave. NW., Wash- § 184.1(b)(1). Current good manufac- ington, DC 20418, or available for in- turing practice results in a maximum spection at the Office of the Federal level, as served, of 0.15 percent for Register, 800 North Capitol Street, baked goods as defined in § 170.3(n)(1) of NW., suite 700, Washington, DC 20408. this chapter and 0.1 percent for gela- (c) In accordance with § 184.1(b)(1), tins and puddings as defined in the ingredient is used in food with no § 170.1(n)(22) of this chapter. limitation other than current good (e) Prior sanctions for this ingredient manufacturing practice. The affirma- different from the uses established in tion of this ingredient as generally rec- this section do not exist or have been ognized as safe (GRAS) as a direct waived. human food ingredient is based upon the following current good manufac- [45 FR 6086, Jan. 25, 1980; 45 FR 16469, Mar. 14, turing practice conditions of use: 1980, as amended at 49 FR 5611, Feb. 14, 1984] (1) The ingredient is used as a dough strengthener as defined in § 170.3(o)(6) § 184.1148 Bacterially-derived of this chapter; a firming agent as de- carbohydrase enzyme preparation. fined in § 170.3(o)(10) of this chapter; a (a) Bacterially-derived carbohydrase leavening agent as defined in enzyme preparation is obtained from § 170.3(o)(17) of this chapter; a pH con- the culture filtrate resulting from a

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pure culture fermentation of a non- (2) The ingredient is used in food at pathogenic and nontoxigenic strain of levels not to exceed current good man- Bacillus subtilis or B. amyloliquefaciens. ufacturing practice. The preparation is characterized by the [64 FR 19894, Apr. 23, 1999] presence of the enzymes a-amylase (EC 3.2.1.1) and b-glucanase (EC 3.2.1.6), § 184.1150 Bacterially-derived protease which catalyze the hydrolysis of O- enzyme preparation. glycosyl bonds in carbohydrates. (a) Bacterially-derived protease en- (b) The ingredient meets the general zyme preparation is obtained from the requirements and additional require- culture filtrate resulting from a pure ments in the monograph on enzyme culture fermentation of a nonpatho- preparations in the Food Chemicals genic and nontoxigenic strain of Bacil- Codex, 4th ed. (1996), pp. 128–135, which lus subtilis or B. amyloliquefaciens. The is incorporated by reference in accord- preparation is characterized by the ance with 5 U.S.C. 552(a) and 1 CFR presence of the enzymes subtilisin (EC part 51. Copies are available from the 3.4.21.62) and neutral proteinase (EC National Academy Press, 2101 Constitu- 3.4.24.28), which catalyze the hydrolysis tion Ave. NW., Washington, DC 20418, of peptide bonds in proteins. or may be examined at the Center for (b) The ingredient meets the general Food Safety and Applied Nutrition’s requirements and additional require- Library, 5100 Paint Branch Pkwy., Col- ments in the monograph on enzyme lege Park, MD 20740, or at the Office of preparations in the Food Chemicals the Federal Register, 800 North Capitol Codex, 4th ed. (1996), pp. 128–135, which Street, NW., Suite 700, Washington, is incorporated by reference in accord- DC. In addition, antibiotic activity is ance with 5 U.S.C. 552(a) and 1 CFR absent in the enzyme preparation when part 51. Copies are available from the determined by an appropriate validated National Academy Press, 2101 Constitu- method such as the method ‘‘Deter- tion Ave. NW., Washington, DC 20418, mination of antibiotic activity’’ in the or may be examined at the Center for Compendium of Food Additive Speci- Food Safety and Applied Nutrition’s fications, vol. 2, Joint FAO/WHO Ex- Library, 5100 Paint Branch Pkwy., Col- pert Committee on Food Additives lege Park, MD 20740, or at the Office of (JECFA), Food and Agriculture Organi- the Federal Register, 800 North Capitol zation of the United Nations, Rome, Street, NW., Suite 700 Washington, DC. 1992. Copies are available from Bernan In addition, antibiotic activity is ab- Associates, 4611–F Assembly Dr., sent in the enzyme preparation when Lanham, MD 20706, or from The United determined by an appropriate validated Nations Bookshop, General Assembly method such as the method ‘‘Deter- Bldg., rm. 32, New York, NY 10017, or mination of antibiotic activity’’ in the by inquiries sent to http://www.fao.org. Compendium of Food Additive Speci- Copies may be examined at the Center fications, vol. 2, Joint FAO/WHO Ex- for Food Safety and Applied Nutri- pert Committee on Food Additives tion’s Library, 5100 Paint Branch (JECFA), Food and Agriculture Organi- Pkwy., College Park, MD 20740. zation of the United Nations, Rome, (c) In accordance with § 184.1(b)(1), 1992. Copies are available from Bernan the ingredient is used in food with no Associates, 4611–F Assembly Dr., limitation other than current good Lanham, MD 20706, or from The United manufacturing practice. The affirma- Nations Bookshop, General Assembly Bldg., rm. 32, New York, NY 10017, or tion of this ingredient as GRAS as a di- by inquiries sent to http://www.fao.org. rect food ingredient is based upon the Copies may be examined at the Center following current good manufacturing for Food Safety and Applied Nutri- practice conditions of use: tion’s Library, 5100 Paint Branch (1) The ingredient is used as an en- Pkwy., College Park, MD 20740. zyme as defined in § 170.3(o)(9) of this (c) In accordance with § 184.1(b)(1), chapter to hydrolyze polysaccharides the ingredient is used in food with no (e.g., starch). limitation other than current good

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manufacturing practice. The affirma- § 184.1157 Benzoyl peroxide. tion of this ingredient as GRAS as a di- (a) Benzoyl peroxide ((C H CO) O , rect food ingredient is based upon the 6 5 2 2 CAS Reg. No. 94–36–0) is a colorless, following current good manufacturing rhombic crystalline solid. It is pre- practice conditions of use: pared by reaction of benzoyl chloride, (1) The ingredient is used as an en- sodium hydroxide, and hydrogen per- zyme as defined in § 170.3(o)(9) of this oxide. chapter to hydrolyze proteins or (b) The ingredient meets the speci- polypeptides. fications of the Food Chemicals Codex, (2) The ingredient is used in food at 3d Ed. (1981), p. 35, which is incor- levels not to exceed current good man- porated by reference. Copies are avail- ufacturing practice. able from the National Academy Press, [64 FR 19895, Apr. 23, 1999] 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- § 184.1155 Bentonite. spection at the Office of the Federal Register, 800 North Capitol Street, (a) Bentonite (Al2O34SiO2nH2O, CAS NW., suite 700, Washington, DC 20408. Reg. No. 1302–0978–099) is principally a (c) In accordance with § 184.1(b)(1), colloidal hydrated aluminum silicate. the ingredient is used in food with no Bentonite contains varying quantities limitation other than current good of iron, alkalies, and alkaline earths in manufacturing practice. The affirma- the commercial products. Depending on tion of this ingredient as generally rec- the cations present, natural deposits of ognized as safe (GRAS) as a direct bentonite range in color from white to human food ingredient is based upon gray, yellow, green, or blue. the following current good manufac- Bentonite’s fine particles provide large turing practice conditions of use: total surface area and, hence, pro- (1) The ingredient is used as a bleach- nounced adsorptive capability. ing agent in food. (b) FDA is developing food-grade (2) The ingredient is used in the fol- specifications for bentonite in coopera- lowing foods at levels not to exceed tion with the National Academy of current good manufacturing practice: Sciences. In the interim, the ingredient flour; milk used for production of must be of a suitable purity for its in- Asiago fresh and Asiago soft cheese tended use. (§ 133.102), Asiago medium cheese (c) In accordance with § 184.1(b)(1), (§ 133.103), Asiago old cheese (§ 133.104), the ingredient is used in food with no Blue cheese (§ 133.106), Caciocavallo limitation other than current good siciliano chesse (§ 133.111), Gorgonzola manufacturing practice. The affirma- cheese (§ 133.141), Parmesan and tion of this ingredient as generally rec- reggiano cheese (§ 133.165), Provolone ognized as safe (GRAS) as a direct cheese (§ 133.181), Romano cheese (§ 133.183), and Swiss and emmentaler human food ingredient is based upon cheese (§ 133.195) in part 133 of this the following current good manufac- chapter; and annatto-colored whey, turing practice conditions of use: such that the final bleached product (1) The ingredient is used as a proc- conforms to the descriptions and speci- essing aid as defined in § 170.3(o)(24) of fications for whey, concentrated whey, this chapter. or dried whey in § 184.1979(a) (1), (2), or (2) The ingredient is used in food at (3), respectively. levels not to exceed current good man- (d) Prior sanctions for this ingredient ufacturing practice. Current good man- different from the uses established in ufacturing practice results in no sig- this section do not exist or have been nificant residue in foods. waived. (d) Prior sanctions for this ingredient [51 FR 27173, July 30, 1986] different from the uses established in this section do not exist or have been § 184.1165 n-Butane and iso-butane. waived. (a) n-Butane and iso-butane (empir- [47 FR 43367, Oct. 1, 1982] ical formula C4H10, CAS Reg. Nos. 106– 489

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97–8 and 75–28–5, respectively) are color- processing aid as defined in § 170.3(o)(24) less, odorless, flammable gases at nor- of this chapter; sequestrant as defined mal temperatures and pressures. They in § 170.3(o)(26) of this chapter; sta- are easily liquefied under pressure at bilizer and thickener as defined in room temperature and are stored and § 170.3(o)(28) of this chapter; and shipped in the liquid state. The butanes texturizer as defined in § 170.3(o)(32) of are obtained from natural gas by frac- this chapter. tionation following absorption in oil, (d) The ingredient is used in food at adsorption to surface-active agents, or levels not to exceed current good man- refrigeration. (b) The Food and Drug Administra- ufacturing practices in accordance tion is developing food-grade specifica- with § 184.1(b)(1). Current good manu- tions for n-butane and iso-butane in co- facturing practices result in a max- operation with the National Academy imum level, as served, of 0.2 percent for of Sciences. In the interim, the ingredi- baked goods as defined in § 170.3(n)(1) of ents must be of a purity suitable for this chapter; 0.02 percent for cheese as their intended use. defined in § 170.3(n)(5) of this chapter; (c) In accordance with § 184.1(b)(1), 0.2 percent for gelatins, puddings, and these ingredients are used in food with fillings as defined in § 170.3(n)(22) of no limitations other than current good this chapter; 0.15 percent for sweet manufacturing practice. The affirma- sauces, toppings, and syrups as defined tion of these ingredients as generally in § 170.3(n)(43) of this chapter; and recognized as safe (GRAS) as direct 0.0001 percent for all other food cat- human food ingredients is based upon egories. the following current good manufac- (e) Prior sanctions for this ingredient turing practice conditions of use: different from the uses established in (1) The ingredients are used as pro- this section or in part 181 of this chap- pellants, aerating agents, and gases as defined in § 170.3(o)(25) of this chapter. ter do not exist or have been waived. (2) The ingredients are used in food [47 FR 27807, June 25, 1982] at levels not to exceed current good manufacturing practice. § 184.1187 Calcium alginate. (d) Prior sanctions for these ingredi- (a) Calcium alginate (CAS Reg. No. ents different from the uses established 9005–35–0) is the calcium salt of alginic in this section do not exist or have been waived. acid, a natural polyuronide constituent of certain brown algae. Calcium algi- [48 FR 57270, Dec. 29, 1983] nate is prepared by the neutralization of purified alginic acid with appro- § 184.1185 Calcium acetate. priate pH control agents, or from so- (a) Calcium acetate (Ca (C2H3O2)2, dium alginate by metathesis with ap- CAS Reg. No. 62–54–4), also known as propriate calcium salts. acetate of lime or vinegar salts, is the (b) The ingredient meets the speci- calcium salt of acetic acid. It may be fications of the Food Chemicals Codex, produced by the calcium hydroxide neutralization of acetic acid. 3d Ed. (1981), p. 45, which is incor- (b) The ingredient meets the speci- porated by reference. Copies are avail- fications of the Food Chemicals Codex, able from the National Academy Press, 3d Ed. (1981), p. 44, which is incor- 2101 Constitution Ave. NW., Wash- porated by reference. Copies are avail- ington, DC 20418, or available for in- able from the National Academy Press, spection at the Office of the Federal 2101 Constitution Ave. NW., Wash- Register, 800 North Capitol Street, ington, DC 20418, or available for in- NW., suite 700, Washington, DC 20408. spection at the Office of the Federal (c) In accordance with § 184.1(b)(2), Register, 800 North Capitol Street, the ingredient is used in food only NW., suite 700, Washington, DC 20408. within the following specific limita- (c) The ingredient is used as a firm- tions: ing agent as defined in § 170.3(o)(10) of this chapter; pH control agent as defined in § 170.3(o)(23) of this chapter;

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Maximum (c) In accordance with § 184.1(b)(1), level of use in the ingredient is used in food with no Category of food food (as Functional use limitation other than current good served) (percent) manufacturing practice. (d) Prior sanctions for this ingredient Baked goods, 0.002 Stabilizer, thickener, different from the uses established in § 170.3(n)(1) of this § 170.3(o)(28) of this chapter. chapter. this section, or different from that set Alcoholic beverages, 0.4 Do. forth in part 181 of this chapter, do not § 170.3(n)(2) of this exist or have been waived. chapter. Confections and 0.4 Do. [48 FR 52441, Nov. 18, 1983] frostings, § 170.3(n)(9) of this § 184.1193 Calcium chloride. chapter. Egg products, 0.6 Do. (a) Calcium chloride (CaCl2·2H2O, § 170.3(n)(11) of this CAS Reg. No. 10035–04–8) or anhydrous chapter. Fats and oils, 0.5 Do. calcium chloride (CaCl2, CAS Reg. No. § 170.3(n)(12) of this 10043–52–4) may be commercially ob- chapter. tained as a byproduct in the ammonia- Gelatins, puddings, 0.25 Do. § 170.3(n)(22) of this soda (Solvay) process and as a joint chapter. product from natural salt brines, or it Gravies and sauces, 0.4 Do. may be prepared by substitution reac- § 170.3(n)(24) of this tions with other calcium and chloride chapter. Jams and jellies, 0.5 Do. salts. § 170.3(n)(28) of this (b) The ingredient meets the speci- chapter. fications of the Food Chemicals Codex, Sweet sauces, 0.5 Do. § 170.3(n)(43) of this 3d Ed. (1981), p. 47, which is incor- chapter. porated by reference. Copies are avail- All other food cat- 0.3 Do. able from the National Academy Press, egories. 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- (d) Prior sanctions for calcium algi- spection at the Office of the Federal nate different from the uses established Register, 800 North Capitol Street, in this section do not exist or have NW., suite 700, Washington, DC 20408. been waived. (c) The ingredient is used as an [47 FR 29951, July 9, 1982] anticaking agent as defined in § 170.3(o)(1) of this chapter; anti- § 184.1191 Calcium carbonate. microbial agent as defined in (a) Calcium carbonate (CaCO3, CAS § 170.3(o)(2) of this chapter; curing or Reg. No. 471–34–1) is prepared by three pickling agent as defined in § 170.3(o)(5) common methods of manufacture: of this chapter; firming agent as de- (1) As a byproduct in the ‘‘Lime soda fined in § 170.3(o)(10) of this chapter; process’’; flavor enhancer as defined in (2) By precipitation of calcium car- § 170.3(o)(11) of this chapter; humectant bonate from calcium hydroxide in the as defined in § 170.3(o)(16) of this chap- ‘‘Carbonation process’’; or ter; nutrient supplement as defined in (3) By precipitation of calcium car- § 170.3(o)(20) of this chapter; pH control bonate from calcium chloride in the agent as defined in § 170.3(o)(23) of this ‘‘Calcium chloride process’’. chapter; processing aid as defined in (b) The ingredient meets the speci- § 170.3(o)(24) of this chapter; stabilizer fications of the Food Chemicals Codex, and thickener as defined in § 170.3(o)(28) 3d Ed. (1981), p. 46, which is incor- of this chapter; surface-active agent as porated by reference. Copies are avail- defined in § 170.3(o)(29) of this chapter; able from the National Academy Press, synergist as defined in § 170.3(o)(31) of 2101 Constitution Ave. NW., Wash- this chapter; and texturizer as defined ington, DC 20418, or available for in- in § 170.3(o)(32) of this chapter. spection at the Office of the Federal (d) The ingredient is used in foods at Register, 800 North Capitol Street, levels not to exceed current good man- NW., suite 700, Washington, DC 20408. ufacturing practices in accordance

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with § 184.1(b)(1). Current good manu- eral Register, 800 North Capitol St. facturing practices result in a max- NW., suite 700, Washington, DC. imum level, as served, of 0.3 percent for (c) In accordance with § 184.1(b)(1), baked goods as defined in § 170.3(n)(1) of the ingredient is used in food with no this chapter and for dairy product limitation other than current good analogs as defined in § 170.3(n)(10) of manufacturing practice. Calcium cit- this chapter; 0.22 percent for non- rate may also be used in infant formula alcoholic beverages and beverage bases in accordance with section 412(g) of the as defined in § 170.3(n)(3) of this chap- Federal Food, Drug, and Cosmetic Act ter; 0.2 percent for cheese as defined in (the act) or with regulations promul- § 170.3(n)(5) of this chapter and for proc- gated under section 412(a)(2) of the act. essed fruit and fruit juices as defined in (d) Prior sanctions for this ingredient § 170.3(n)(35) of this chapter; 0.32 per- different from the uses established in cent for coffee and tea as defined in this section do not exist or have been § 170.3(n)(7) of this chapter; 0.4 percent waived. for condiments and relishes as defined [59 FR 63896, Dec. 12, 1994] in § 170.3(n)(8) of this chapter; 0.2 percent for gravies and sauces as defined § 184.1199 Calcium gluconate. in § 170.3(n)(24) of this chapter; 0.1 per- (a) Calcium gluconate cent for commercial jams and jellies as ([CH2OH(CHOH)4COO]2Ca, CAS Reg. No. defined in § 170.3(n)(28) of this chapter; 299–28–5) is the calcium salt of gluconic 0.25 percent for meat products as de- acid which may be produced by neu- fined in § 170.3(n)(29) of this chapter; 2.0 tralization of gluconic acid with lime percent for plant protein products as or calcium carbonate. defined in § 170.3(n)(33) of this chapter; (b) The ingredient meets the speci- 0.4 percent for processed vegetables and fications of the Food Chemicals Codex, vegetable juices as defined in 3d Ed. (1981), p. 51, which is incor- § 170.3(n)(36) of this chapter; and 0.05 porated by reference. Copies are avail- percent for all other food categories. able from the National Academy Press, (e) Prior sanctions for this ingredient 2101 Constitution Ave. NW., Wash- different from the uses established in ington, DC 20418, or available for in- this section do not exist or have been spection at the Office of the Federal waived. Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [47 FR 27808, June 25, 1982, as amended at 61 (c) The ingredient is used as a firm- FR 14247, Apr. 1, 1996] ing agent as defined in § 170.3(o)(10) of this chapter; formulation aid as defined § 184.1195 Calcium citrate. in § 170.3(o)(14) of this chapter; (a) Calcium citrate sequestrant as defined in § 170.3(o)(26) of (Ca3(C6H5O7)2·4H2O, CAS Reg. No. 813– this chapter; stabilizer or thickener as 0994–095) is the calcium salt of citric defined in § 170.3(o)(28) of this chapter; acid. It is prepared by neutralizing cit- and texturizer as defined in § 170.3(o)(32) ric acid with calcium hydroxide or cal- of this chapter. cium carbonate. It occurs as a fine (d) The ingredient is used in foods at white, odorless powder and usually levels not to exceed current good man- contains four moles of water per mole ufacturing practices in accordance of calcium citrate. with § 184.1(b)(1). Current good manu- (b) The ingredient meets the speci- facturing practices result in a max- fications of the Food Chemicals Codex, imum level, as served, of 1.75 percent 3d ed. (1981), pp. 49 and 50, which is infor baked goods as defined in corporated by reference in accordance § 170.3(n)(1) of this chapter; 0.4 percent with 5 U.S.C. 552(a) and 1 CFR part 51. for dairy product analogs as defined in Copies are available from the National § 170.3(n)(10) of this chapter; 4.5 percent Academy Press, 2101 Constitution Ave. for gelatins and puddings as defined in NW., Washington, DC 20418, and the § 170.3(n)(22) of this chapter; and 0.01 Center for Food Safety and Applied Nu- percent for sugar substitutes as defined trition (HFS–200), 5100 Paint Branch in § 170.3(n)(42) of this chapter. Pkwy., College Park, MD 20740, or may (e) Prior sanctions for this ingredient be examined at the Office of the Fed- different from the uses established in

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this section do not exist or have been 2101 Constitution Ave. NW., Wash- waived. ington, DC 20418, or available for in- [47 FR 27808, June 25, 1982] spection at the Office of the Federal Register, 800 North Capitol Street, § 184.1201 Calcium glycerophosphate. NW., suite 700, Washington, DC 20408. (a) Calcium glycerophosphate (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no (C3H7CaO6P, CAS Reg. No. 27214–00–2) is a fine, white, odorless, almost taste- limitation other than current good less, slightly hygroscopic powder. It is manufacturing practice. prepared by neutralizing glycero- (d) Prior sanctions for this ingredient phosphoric acid with calcium hydrox- different from the uses established in ide or calcium carbonate. The commer- this section do not exist or have been cial product is a mixture of calcium b- waived. , and D-, and L- -glycerophosphate. a [49 FR 26714, June 29, 1984] (b) The ingredient meets the specifications of the ‘‘Food Chemicals § 184.1206 Calcium iodate. Codex,’’ 3d Ed. (1981), pp. 51–52, which is incorporated by reference in accord- (a) Calcium iodate [Ca(IO3)2·H2O, CAS ance with 5 U.S.C. 552(a) and 1 CFR Reg. No. 7789–80–2], also referred to as part 51. Copies may be obtained from lautarite, does not occur naturally but the National Academy Press, 2101 Con- can be prepared by passing chlorine stitution Ave. NW., Washington, DC into a hot solution of lime (CaCO3) in 20418, or may be examined at the Office which iodine has been dissolved. of the Federal Register, 800 North Cap- (b) The ingredient meets the speci- itol Street, NW., suite 700, Washington, fications of the ‘‘Food Chemicals DC. Codex,’’ 3d Ed. (1981), p. 53, which is in- (c) In accordance with § 184.1(b)(1), corporated by reference. Copies may be the ingredient is used in food with no obtained from the National Academy limitation other than current good Press, 2101 Constitution Ave. NW., manufacturing practice. The affirma- Washington, DC 20418, or may be exam- tion of this ingredient as generally rec- ined at the Office of the Federal Reg- ognized as safe (GRAS) as a direct ister, 800 North Capitol Street, NW., human food ingredient is based upon suite 700, Washington, DC 20408. the following current good manufac- (c) The ingredient is used as a dough turing practice conditions of use: strengthener as defined in § 170.3(o)(6) (1) The ingredient is used as a nutri- of this chapter. ent supplement as defined in (d) The ingredient is used in the man- § 170.3(o)(20) of this chapter. ufacture of bread in accordance with (2) The ingredient is used in gelatins, § 184.1(b)(2) of this chapter in an puddings, and fillings as defined in amount not to exceed 0.0075 percent § 170.3(n)(22) of this chapter. based on the weight of the flour. (d) Prior sanctions for this ingredient (e) Prior sanctions for this ingredient different from the uses established in this section or different from that as different from the uses established in set forth in part 181 of this chapter, do this section do not exist or have been not exist or have been waived. waived. [57 FR 10813, Mar. 31, 1992] [43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5611, Feb. 14, 1984] § 184.1205 Calcium hydroxide. § 184.1207 Calcium lactate. (a) Calcium hydroxide (Ca(OH)2, CAS Reg. No. 1305–62–0) is also known as (a) Calcium lactate (C6H10CaO6.xH2O, slaked lime or calcium hydrate. It is where x is any integer up to 5, CAS produced by the hydration of lime. Reg. No. 814–80–2) is prepared commer- (b) The ingredient meets the speci- cially by the neutralization of lactic fications of the Food Chemicals Codex, acid with calcium carbonate or cal- 3d Ed. (1981), p. 52, which is incor- cium hydroxide. porated by reference. Copies are avail- (b) The ingredient meets the speci- able from the National Academy Press, fications of the Food Chemicals Codex,

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3d Ed. (1981), p. 53, which is incor- (d) Prior sanctions for this ingredient porated by reference. Copies are avail- different from the uses established in able from the National Academy Press, this section do not exist or have been 2101 Constitution Avenue NW., Wash- waived. ington, DC 20418, or available for inspection at the Office of the Federal [49 FR 26714, June 29, 1984] Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. § 184.1212 Calcium pantothenate. (c) In accordance with § 184.1(b)(1), (a) Calcium pantothenate the ingredient is used in food with no ((C9H16NO5)2Ca, CAS Reg. No. of the D- limitation other than current good isomer, 137–08–6) is a salt of panto- manufacturing practice. The affirma- thenic acid, one of the vitamins of the tion of this ingredient as generally rec- B complex. Only the D-isomer of panto- ognized as safe (GRAS) as a direct thenic acid has vitamin activity, al- human food ingredient is based upon though both the D-isomer and the DL- the following current good manufac- racemic mixture of calcium panto- turing practice conditions of use: thenate are used in food. Commercial (1) The ingredient is used as a firm- calcium pantothenate is prepared syn- ing agent as defined in § 170.3(o)(10) of thetically from isobutyraldehyde and this chapter; a flavor enhancer as de- formaldehyde via 1,1-dimethyl-2-hy- fined in § 170.3(o)(11) of this chapter; a flavoring agent or adjuvant as defined droxy-propionaldehyde and in § 170.3(o)(12) of this chapter; a leav- pantolactone. ening agent as defined in § 170.3(o)(17) of (b) Calcium pantothenate meets the this chapter; a nutrient supplement as specifications of the Food Chemicals defined in § 170.3(o)(20) of this chapter; Codex, 3d Ed. (1981), p. 56, which is in- and a stabilizer and thickener as de- corporated by reference. Copies are fined in § 170.3(o)(28) of this chapter. available from the National Academy (2) The ingredient is used in food, ex- Press, 2101 Constitution Ave. NW., cept in infant foods and infant for- Washington, DC 20418, or available for mulas, at levels not to exceed current inspection at the Office of the Federal good manufacturing practice. Register, 800 North Capitol Street, (d) Prior sanctions for this ingredient NW., suite 700, Washington, DC 20408. different from the uses established in (c) In accordance with § 184.1(b)(1), this section do not exist or have been the ingredient is used in food with no waived. limitation other than current good [49 FR 35367, Sept. 7, 1984] manufacturing practice. The affirmation of this ingredient as generally rec- § 184.1210 Calcium oxide. ognized as safe (GRAS) as a direct (a) Calcium oxide (CaO, CAS Reg. No. human food ingredient is based upon 1305–78–8) is also known as lime, quick the following current good manufac- lime, burnt lime, or calx. It is produced turing practice conditions of use: from calcium carbonate, limestone, or (1) The ingredient is used as a nutri- oyster shells by calcination at tem- ent supplement as defined in peratures of 1,700–2,450 °F. § 170.3(o)(20) of this chapter. (b) The ingredient meets the speci- (2) The ingredient is used in foods at fications of the Food Chemicals Codex, levels not to exceed current good man- 3d Ed. (1981), p. 55, which is incor- ufacturing practice. Calcium panto- porated by reference. Copies are avail- thenate may be used in infant formula able from the National Academy Press, in accordance with section 412(g) of the 2101 Constitution Ave. NW., Wash- Federal Food, Drug, and Cosmetic Act ington, DC 20418, or available for in- (the act) or with regulations promul- spection at the Office of the Federal gated under section 412(a)(2) of the Act. Register, 800 North Capitol Street, (d) Prior sanctions for this ingredient NW., suite 700, Washington, DC 20408. different from the uses established in (c) In accordance with § 184.1(b)(1), this section do not exist or have been the ingredient is used in food with no waived. limitation other than current good manufacturing practice. [48 FR 51908, Nov. 15, 1983]

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§ 184.1221 Calcium propionate. 3d Ed. (1981), p. 64, which is incorporated by reference, and the require- (a) Calcium propionate (C H CaO , 6 10 4 ments of § 172.860(b)(2) of this chapter. CAS Reg. No. 4075–81–4) is the calcium Copies of the Food Chemicals Codex salt of propionic acid. It occurs as are available from the National Acad- white crystals or a crystalline solid, emy Press, 2101 Constitution Ave. NW., possessing not more than a faint odor Washington, DC 20418, or available for of propionic acid. It is prepared by neu- inspection at the Office of the Federal tralizing propionic acid with calcium Register, 800 North Capitol Street, hydroxide. NW., suite 700, Washington, DC 20408. (b) The ingredient meets the speci- (c) In accordance with § 184.1(b)(1), fications of the Food Chemicals Codex, the ingredient is used in food with no 3d Ed. (1981), p. 60, which is incor- limitation other than current good porated by reference. Copies are avail- manufacturing practice. The affirma- able from the National Academy Press, tion of this ingredient as generally rec- 2101 Constitution Ave. NW., Wash- ognized as safe (GRAS) as a direct ington, DC 20418, or available for in- human food ingredient is based upon spection at the Office of the Federal the following current good manufac- Register, 800 North Capitol Street, turing practice conditions of use: NW., suite 700, Washington, DC 20408. (1) The ingredient is used as a fla- (c) In accordance with § 184.1(b)(1), voring agent and adjuvant as defined in the ingredient is used in food with no § 170.3(o)(12) of this chapter; a lubricant limitation other than current good and release agent as defined in manufacturing practice. The affirma- § 170.3(o)(18) of this chapter; and a station of this ingredient as generally rec- bilizer and thickener as defined in ognized as safe (GRAS) as a direct § 170.3(o)(28) of this chapter. human food ingredient is based upon (2) The ingredient is used in foods at the following current good manufac- levels not to exceed current good man- turing practice conditions of use: ufacturing practice. (1) The ingredient is used as an anti- (d) Prior sanctions for this ingredient microbial agent as defined in different from the uses established in § 170.3(o)(2) of this chapter. this section do not exist or have been (2) The ingredient is used in the fol- waived. lowing foods at levels not to exceed current good manufacturing practice: [48 FR 52445, Nov. 18, 1983] baked goods as defined in § 170.3(n)(1) of § 184.1230 Calcium sulfate. this chapter; cheeses as defined in § 170.3(n)(5) of this chapter; confections (a) Calcium sulfate (CaSO4, CAS Reg. and frostings as defined in § 170.3(n)(9) No. 7778–18–9 or CaSO4·2H2O, CAS Reg. of this chapter; gelatins, puddings, and No. 10101–41–4), also known as plaster of fillings as defined in § 170.3(n)(22) of Paris, anhydrite, and gypsum, occurs this chapter; and jams and jellies as de- naturally and exists as a fine, white to fined in § 170.3(n)(28) of this chapter. slightly yellow-white odorless powder. (d) Prior sanctions for this ingredient The anhydrous form is prepared by different from the uses established in complete dehydration of gypsum, below ° this section do not exist or have been 300 C, in an electric oven. waived. (b) The ingredient meets the specifications of the ‘‘Food Chemicals [49 FR 13141, Apr. 3, 1984] Codex,’’ 3d Ed. (1981), p. 66, which is incorporated by reference. Copies may be § 184.1229 Calcium stearate. obtained from the National Academy (a) Calcium stearate (Ca(C17H35COO)2, Press, 2101 Constitution Ave. NW., CAS Reg. No. 1529–23–0) is the calcium Washington, DC 20418, or may be exam- salt of stearic acid derived from edible ined at the Office of the Federal Reg- sources. It is prepared as a white pre- ister, 800 North Capitol Street, NW., cipitate by mixing calcium chloride suite 700, Washington, DC 20408. and sodium stearate in aqueous solu- (c) The ingredient is used as an tion. anticaking agent as defined in (b) The ingredient meets the speci- § 170.3(o)(1) of this chapter, color and fications of the Food Chemicals Codex, coloring adjunct as defined in

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§ 170.3(o)(4) of this chapter, dough processes, and from gases found in cer- strengthener as defined in § 170.3(o)(6) tain natural springs and wells. of this chapter, drying agent as defined (b) The Food and Drug Administra- in § 170.3(o)(7) of this chapter, firming tion is developing food-grade specifica- agent as defined in § 170.3(o)(10) of this tions for carbon dioxide in cooperation chapter, flour treating agent as defined with the National Academy of in § 170.3(o)(13) of this chapter, formula- Sciences. In the interim, the ingredient tion aid as defined in § 170.3(o)(14) of must be of purity suitable for its in- this chapter, leavening agent as de- tended use. fined in § 170.3(o)(17) of this chapter, nu- (c) In accordance with § 184.1(b)(1), trient supplement as defined in the ingredient is used in food with no § 170.3(o)(20) of this chapter, pH control limitations other than current good agent as defined in § 170.3(o)(23) of this manufacturing practice. The affirma- chapter, processing aid as defined in tion of this ingredient as generally rec- § 170.3(o)(24) of this chapter, stabilizer ognized as safe (GRAS) as a direct and thickener as defined in § 170.3(o)(28) human food ingredient is based upon of this chapter, synergist as defined in § 170.3(o)(31) of this chapter, and the following current good manufac- texturizer as defined in § 170.3(o)(32) of turing practice conditions of use: this chapter. (1) The ingredient is used as a leav- (d) The ingredient is used in food at ening agent as defined in § 170.3(o)(17) of levels not to exceed good manufac- this chapter; a processing aid as de- turing practice in accordance with fined in § 170.3(o)(24) of this chapter; § 184.1(b)(1). Current good manufac- and a propellant, aerating agent, and turing practice results in a maximum gas as defined in § 170.3(o)(25) of this level, as served, of 1.3 percent for baked chapter. goods as defined in § 170.3(n)(1) of this (2) The ingredient is used in food at chapter, 3.0 percent for confections and levels not to exceed current good man- frostings as defined in § 170.3(n)(9) of ufacturing practice. this chapter, 0.5 percent for frozen (d) Prior sanctions for this ingredient dairy desserts and mixes as defined in different from the uses established in § 170.3(n)(20) of this chapter, 0.4 percent this section do not exist or have been for gelatins and puddings as defined in waived. § 170.3(n)(22) of this chapter, 0.5 percent for grain products and pastas as de- [48 FR 57270, Dec. 29, 1983] fined in § 170.3(n)(23) of this chapter, 0.35 percent for processed vegetables as § 184.1245 Beta-carotene. defined in § 170.3(n)(36) of this chapter, (a) Beta-carotene (CAS Reg. No. 7235– and 0.07 percent or less for all other 40–7) has the molecular formula C40H56. food categories. It is synthesized by saponification of (e) Prior sanctions for this ingredient vitamin A acetate. The resulting alco- different from the uses established in hol is either reacted to form vitamin A this section do not exist or have been Wittig reagent or oxidized to vitamin A waived. aldehyde. Vitamin A Wittig reagent [45 FR 6086, Jan. 25, 1980; 45 FR 26319, Apr. 18, and vitamin A aldehyde are reacted to- 1980, as amended at 49 FR 5611, Feb. 14, 1984] gether to form beta-carotene. (b) The ingredient meets the speci- § 184.1240 Carbon dioxide. fications of the Food Chemicals Codex, (a) Carbon dioxide (empirical formula 3d Ed. (1981), p. 73, which is incor- CO2, CAS Reg. No. 124–38–9) occurs as a porated by reference. Copies are avail- colorless, odorless, noncombustible gas able from the National Academy Press, at normal temperatures and pressures. 2101 Constitution Ave. NW., The solid form, dry ice, sublimes under Washingtion, DC 20418, or available for atmospheric pressure at a temperature inspection at the Office of the Federal of ¥78.5 °C. Carbon dioxide is prepared Register, 800 North Capitol Street, as a byproduct of the manufacture of NW., suite 700, Washington, DC 20408. lime during the ‘‘burning’’ of lime- (c) In accordance with § 184.1(b)(1), stone, from the combustion of carbo- the ingredient is used in food with no naceous material, from fermentation limitation other than current good

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manufacturing practice. The affirma- (c) In accordance with § 184.1(b)(1), tion of this ingredient as generally rec- the ingredient is used in food with no ognized as safe (GRAS) as a direct limitation other than current good human food ingredient is based upon manufacturing practice. The affirma- the following current good manufac- tion of this ingredient as generally rec- turing practice conditions of use: ognized as safe (GRAS) as a direct (1) The ingredient is used as a nutri- human food ingredient is based upon ent supplement as defined in the following current good manufac- § 170.3(o)(20) of this chapter. turing practice conditions of use: (2) The ingredient is used in the fol- (1) The ingredient is used in food as lowing foods at levels not to exceed an enzyme as defined in § 170.3(o)(9) of current good manufacturing practice: this chapter for the breakdown of cel- dairy product analogs as defined in lulose. § 170.3(n)(10) of this chapter; fats and (2) The ingredient is used in food at oils as defined in § 170.3(n)(12) of this levels not to exceed current good man- chapter; and processed fruits and fruit ufacturing practice. juices as defined in § 170.3(n)(35) of this [64 FR 28361, May 26, 1999] chapter. Beta-carotene may be used in infant formula as a source of vitamin A § 184.1257 Clove and its derivatives. in accordance with section 412(g) of the (a) Cloves are the dried unopened Federal Food, Drug, and Cosmetic Act flower buds and calyx tubes, harvested or with regulations promulgated under before the flowers have opened, of the section 412(g) of the act. clove tree Eugenia caryophyllata (d) Prior sanctions for this ingredient Thunberg, native to tropical Asia. different from the uses established in Their derivatives include essential oils this section do not exist or have been (cloves, CAS Reg. No. 8000–34–8; buds; waived. leaves, CAS Reg. No. 8015–97–2; stems, [52 FR 25211, July 6, 1987] CAS Reg. No. 8015–98–3; and eugenol, CAS Reg. No. 97–53–0), oleoresins, and § 184.1250 Cellulase enzyme prepara- natural extractives obtained from tion derived from Trichoderma clove buds, leaves, and stems. longibrachiatum. (b) Clove bud oil, clove leaf oil, clove (a) Cellulase enzyme preparation is stem oil, and eugenol meet the speci- derived from a nonpathogenic, fications of the ‘‘Food Chemicals nontoxicogenic strain of Trichoderma Codex,’’ 4th ed. (1996), pp. 104–105, which longibrachiatum (formerly T. reesei). The is incorporated by reference in accord- enzyme, cellulase, catalyzes the ance with 5 U.S.C. 552(a) and 1 CFR endohydrolysis of 1,4-beta-glycosidic part 51. Copies are available from the linkages in cellulose. It is obtained National Academy Press, Box 285, 2101 from the culture filtrate resulting from Constitution Ave. NW., Washington, a pure culture fermentation process. DC 20055 (Internet address http:// (b) The ingredient meets the general www.nap.edu), or may be examined at and additional requirements for en- the Center for Food Safety and Applied zyme preparations in the monograph Nutrition’s Library, Food and Drug Ad- specifications on enzyme preparations ministration, 5100 Paint Branch Pkwy., in the ‘‘Food Chemicals Codex,’’ 4th ed. College Park, MD 20740, or at the Office (1996), pp. 129 to 134, which is incor- of the Federal Register, 800 North Cap- porated by reference in accordance itol St. NW., suite 700, Washington, DC. with 5 U.S.C. 552(a) and 1 CFR part 51. As determined by analytical methods Copies are available from the National in the ‘‘Food Chemicals Codex,’’ clove Academy Press, 2101 Constitution Ave. oleoresin or other natural extractives NW., Box 285, Washington, DC 20055 (other than clove oils) meet the ‘‘Food (Internet http://www.nap.edu), or may Chemicals Codex’’ specifications for be examined at the Center for Food clove (clove bud) oil and the following Safety and Applied Nutrition’s Li- modifications: brary, 5100 Paint Branch Pkwy., Col- (1) The assay for phenols, as eugenol, lege Park, MD 20740, or at the Office of by the ‘‘Food Chemicals Codex’’ test, the Federal Register, 800 North Capitol 4th ed. (pp. 104–105), or the volatile oils St. NW., suite 700, Washington, DC. content by the ‘‘Food Chemicals

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Codex’’ test, 4th ed. (pp. 104–105) should zyme preparation that is either GRAS conform to the representation of the or has food additive approval for such vendor; use. (2) Optical rotation of the volatile oil (b) The ingredient meets the fol- between ¥2° and 0°; lowing specifications: (3) Refractive index of the volatile oil (1) Over 90 percent triglycerides, not between 1.527 and 1.538 at 20 °C; more than 7 percent diglycerides, not (4) Specific gravity of the volatile oil more than 1 percent monoglycerides, between 1.036 and 1.060; and and not more than 1 percent free fatty (5) Residual solvent free, except those acids. solvents that are GRAS or within tol- (2) Total glycerides—98 percent min- erance levels as specified in part 173, imum. subpart C, of this chapter. (3) Heavy metals (as lead), not more (c) Clove and its derivatives are used than 10 milligrams per kilogram, as de- as flavoring agents and adjuvants as termined by the Heavy Metals Test of defined in § 170.3(0)(12) of this chapter. the ‘‘Food Chemicals Codex,’’ 4th ed. (d) The ingredients are used in food (1996), pp. 760–761, which is incorporated at levels not to exceed good manufac- by reference in accordance with 5 turing practice in accordance with U.S.C. 552(a) and 1 CFR part 51. Copies § 184.1(b)(1). are available from the National Acad- (e) Prior sanctions for these ingredi- emy Press, Box 285, 2101 Constitution ents different from the uses established Ave. NW., Washington, DC 20055 (Inter- in this section do not exist or have net address http://www.nap.edu), or been waived. may be examined at the Center for [44 FR 3964, Jan 19, 1979, as amended at 47 FR Food Safety and Applied Nutrition’s 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, 1984; Library, Food and Drug Administra- 64 FR 1759, Jan. 12, 1999] tion, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the Office of the § 184.1259 Cocoa butter substitute. Federal Register, 800 North Capitol St. (a) The common or usual name for NW., suite 700, Washington, DC. the triglyceride 1-palmitoyl-2-oleoyl-3- (4) Color—clear, bright, and free from stearin is ‘‘cocoa butter substitute pri- suspended matter. marily from palm oil.’’ The common or (5) Odor and taste—free from foreign usual name for the triglyceride 1-3- and rancid odor and taste. distearoyl-2-olein is ‘‘cocoa butter sub- (6) Residual catalyst (‘‘Official Meth- stitute primarily from high-oleic saf- ods of Analysis of the Association of flower or sunflower oil.’’ Official Analytical Chemists,’’ 13th Ed. (1) The ingredient 1-palmitoyl-2-ole- (1980), sections 25.049–25.055, which is oyl-3-stearin is manufactured by: incorporated by reference), residual (i) Directed esterification of fully fluorine; limit of detection 0.2 part per saturated 1,3-diglycerides (derived from million F; multiply fluoride result by palm oil) with the anhydride of food- 2.63 to convert to residual catalyst. grade oleic acid in the presence of the Copies of the material incorporated by catalyst trifluoromethane sulfonic acid reference may be obtained from the As- (§ 173.395 of this chapter), or sociation of Official Analytical Chem- (ii) By interesterification of partially ists, P.O. Box 540, Benjamin Franklin saturated 1,2,3-triglycerides (derived Station, Washington, DC 20044, or may from palm oil) with ethyl stearate in be examined at the Office of the Fed- the presence of a suitable lipase en- eral Register, 800 North Capitol Street, zyme preparation that is either gen- NW., suite 700, Washington, DC 20408. erally recognized as safe (GRAS) or has The ingredient shall be washed three food additive approval for such use. times in batches with 0.5 percent so- (2) The ingredient 1-3-distearoyl-2- dium bicarbonate to remove catalyst olein is manufactured by residuals in accordance with good man- interesterification of partially unsatu- ufacturing practice. rated 1,2,3-triglycerides (derived from (7) Residual methanol—5 parts per high-oleic safflower or sunflower oil) million maximum. with ethyl stearate or stearic acid in (8) Residual fatty acid ethyl esters— the presence of a suitable lipase en- not more than 20 parts per million as

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determined by a ‘‘Modification of odorless crystals, or as a fine, light Japan Institute of Oils and Fats: Anal- blue powder. It is prepared by the reac- ysis Method of Residual Ethyl Esters of tion of gluconic acid solutions with cu- Fatty Acids’’ issued by the Fuji Oil pric oxide or basic cupric carbonate. Co., which is incorporated by reference. (b) The ingredient meets the speci- Copies are available from the Division fications of the Food Chemicals Codex, of Food and Color Additives, Center for 3d Ed. (1981), p. 90, which is incor- Food Safety and Applied Nutrition porated by reference. Copies are avail- (HFS–200), Food and Drug Administra- able from the National Academy Press, tion, 5100 Paint Branch Pkwy., College 2101 Constitution Ave. NW., Wash- Park, MD 20740, or available for inspec- ington, DC. 20418, or available for in- tion at the Office of the Federal Reg- spection at the Office of the Federal ister, 800 North Capitol Street, NW., Register, 800 North Capitol Street, suite 700, Washington, DC 20408. NW., suite 700, Washington, DC. 20408. (9) Hexane—not more than 5 parts per (c) In accordance with § 184.1(b)(1), million as determined by the method of the ingredient is used in food with no Dupuy et al., ‘‘Rapid Quantitative De- limitation other than current good termination of Residual Hexane in Oils manufacturing practice. The affirma- by Direct Gas Chromatography,’’ pub- tion of this ingredient as generally rec- lished in the ‘‘Journal of the American ognized as safe (GRAS) as a direct Oil Chemists’ Society,’’ Vol. 52, p. 118– human food ingredient is based upon 120, 1975, which is incorporated by ref- the following current good manufac- erence. Copies are available from the turing practice conditions of use: Division of Food and Color Additives, (1) The ingredient is used as a nutri- Center for Food Safety and Applied Nu- ent supplement as defined in trition (HFS–200), Food and Drug Ad- § 170.3(o)(20) of this chapter and as a ministration, 5100 Paint Branch Pkwy., synergist as defined in § 170.3(o)(31) of College Park, MD 20740, or available for this chapter. inspection at the Office of the Federal (2) The ingredient is used in food at Register, 800 North Capitol Street, levels not to exceed current good man- NW., suite 700, Washington, DC 20408. ufacturing practice. Copper gluconate (c) In accordance with § 184.1(b)(1), may be used in infant formula in ac- the ingredient is used in the following cordance with section 412(g) of the Fed- food categories at levels not to exceed eral Food, Drug, and Cosmetic Act (the current good manufacturing practice: Act) or with regulations promulgated Confections and frostings as defined in under section 412(a)(2) of the Act. § 170.3(n)(9) of this chapter; coatings of (d) Prior sanctions for this ingredient soft candy as defined in §170.3(n)(38) of different from the uses established in this chapter; and sweet sauces and top- this section do not exist or have been pings as defined in §170.3(n)(43) of this waived. chapter; except that the ingredient may not be used in a standardized food [49 FR 24119, June 12, 1984] unless permitted by the standard of identity. § 184.1261 Copper sulfate. (d) The ingredient is used in food in (a) Copper sulfate (cupric sulfate, accordance with § 184.1(b)(1) at levels CuSO4·5H2O, CAS Reg. No. 7758–98–7) not to exceed good manufacturing usually is used in the pentahydrate practice. form. This form occurs as large, deep [43 FR 54239, Nov. 11, 1978, as amended at 47 blue or ultramarine, triclinic crystals; FR 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, as blue granules, or as a light blue pow- 1984; 49 FR 22799, June 1, 1984; 52 FR 47920, der. The ingredient is prepared by the Dec. 17, 1987; 52 FR 48905, Dec. 28, 1987; 61 FR reaction of sulfuric acid with cupric 36290, July 10, 1996; 64 FR 1760, Jan. 12, 1999] oxide or with copper metal. (b) FDA is developing food-grade § 184.1260 Copper gluconate. specifications for copper sulfate in co- (a) Copper gluconate (cupric gluco- operation with the National Academy nate (CH2OH(CHOH)4COO)2Cu, CAS of Sciences. In the interim, this ingre- Reg. No. 527–09–3) is a substance that dient must be of a purity suitable for occurs as light blue to bluish-green, its intended use.

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(c) In accordance with § 184.1(b)(1), Maximum the ingredient is used in food with no level of Category of food use in Functional use limitation other than current good food (as manufacturing practice. The affirma- served)1 tion of this ingredient as generally rec- Frozen dairy desserts, 10 Do. ognized as safe (GRAS) as a direct § 170.3(n)(20) of this human food ingredient is based upon chapter. Soft candy, 20 Do. the following current good manufac- § 170.3(n)(38) of this turing practice conditions of use: chapter. (1) The ingredient is used as a nutri- All other food cat- 4 Do. ent supplement as defined in egories. § 170.3(o)(20) of this chapter and as a 1 Parts per million. processing aid as defined in § 170.3(o)(24) (d) Prior sanctions for this ingredient of this chapter. different from the uses established in (2) The ingredient is used in food at this section do not exist or have been levels not to exceed current good man- waived. ufacturing practice. Copper sulfate may be used in infant formula in ac- [47 FR 29953, July 9, 1982] cordance with section 412(g) of the Fed- § 184.1265 Cuprous iodide. eral Food, Drug, and Cosmetic Act (the Act) or with regulations promulgated (a) Cuprous iodide (copper (I) iodide, under section 412(a)(2) of the Act. CuI, CAS Reg. No. 7681–65–4) is a pure (d) Prior sanctions for this ingredient white crystalline powder. It is prepared by the reaction of copper sulfate with different from the uses established in potassium iodide under slightly acidic this section do not exist or have been conditions. waived. (b) FDA is developing food-grade [49 FR 24119, June 12, 1984] specifications for cuprous iodide in cooperation with the National Academy § 184.1262 Corn silk and corn silk ex- of Sciences. In the interim, this ingre- tract. dient must be of a purity suitable for (a) Corn silk is the fresh styles and its intended use. stigmas of Zea mays L. collected when (c) In accordance with § 184.1(b)(2), the corn is in milk. The filaments are the ingredient is used in food only extracted with dilute ethanol to within the following specific limita- produce corn silk extract. The extract tions: may be concentrated at a temperature Cat- not exceeding 60 °C. egory Maximum treatment Functional use (b) The Food and Drug Administra- of food level in food tion, in cooperation with the National Table 0.01 percent ...... Source of dietary iodine. Academy of Sciences, is developing salt. food-grade specifications for corn silk and corn silk extract. In the interim, (d) Prior sanctions for this ingredient this ingredient must be of a suitable different from the uses established in purity for its intended use. this section do not exist or have been (c) In accordance with § 184.1(b)(2), waived. the ingredients are used in food only [49 FR 24119, June 12, 1984] within the following specific limitations: § 184.1271 L-Cysteine.

Maximum (a) L-Cysteine is the chemical L-2- level of amino-3-mercaptopropanoic acid Category of food use in Functional use food (as (C3H7O2NS). served)1 (b) The ingredient meets the appropriate part of the specification set Baked goods and bak- 30 Flavoring agent, ing mixes, § 170.3(o)(12) of this forth in the ‘‘Food Chemicals Codex,’’ § 170.3(n)(1) of this chapter. 3d Ed. (1981), pp. 92–93, which is incor- chapter. porated by reference. Copies may be Nonalcoholic bev- 20 Do. erages, § 170.3(n)(3) obtained from the National Academy of this chapter. Press, 2101 Constitution Ave. NW.,

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Washington, DC 20418, or may be exam- trol agents and (2) drying the acid or ined at the Office of the Federal Reg- alkali treated starch. ister, 800 North Capitol Street, NW., (b) The ingredient meets the speci- suite 700, Washington, DC 20408. fication of the Food Chemicals Codex, (c) The ingredient is used to supply 3d Ed. (1981), p. 96, which is incor- up to 0.009 part of total L-cysteine per porated by reference. Copies are avail- 100 parts of flour in dough as a dough able from the National Academy Press, strengthener as defined in § 170.3(o)(6) 2101 Constitution Ave. NW., Wash- of this chapter in yeast-leavened baked ington, DC 20418, or available for in- goods and baking mixes as defined in spection at the Office of the Federal § 170.3(n)(1) of this chapter. Register, 800 North Capitol Street, (d) This regulation is issued prior to NW., suite 700, Washington, DC 20408. a general evaluation of use of this in- (c) In accordance with § 184.1(b)(1), gredient in order to affirm as GRAS the ingredient is used in food with no the specific use named. limitation other than current good manufacturing practice. The affirma- [42 FR 14653, Mar. 15, 1977, as amended at 49 tion of this ingredient as generally rec- FR 5612, Feb. 14, 1984] ognized as safe (GRAS) as a direct human food ingredient is based upon § 184.1272 L-Cysteine monohydrochloride. the following current good manufacturing practice conditions of use: (a) L-Cysteine monohydrochloride is (1) The ingredient is used as a formu- the chemical L-2-amino-3- lation aid as defined in § 170.3(o)(14) of mercaptopropanoic acid this chapter; as a processing aid as de- monohydrochloride monohydrate fined in § 170.3(o)(24) of this chapter; as (C3H7O2NS HCl H2O). a stabilizer and thickener as defined in (b) The ingredient meets the speci- § 170.3(o)(28) of this chapter; and as a fications of the ‘‘Food Chemicals surface-finishing agent as defined in Codex,’’ 3d Ed. (1981), pp. 92–93, which is § 170.3(o)(30) of this chapter. incorporated by reference. Copies may (2) The ingredient is used in food at be obtained from the National Acad- levels not to exceed current good man- emy Press, 2101 Constitution Ave. NW., ufacturing practice. Washington, DC 20418, or may be exam- (d) Prior sanctions for this ingredient ined at the Office of the Federal Reg- different from the uses established in ister, 800 North Capitol Street, NW., this section do not exist or have been suite 700, Washington, DC 20408. waived. (c) The ingredient is used to supply [48 FR 51909, Nov. 15, 1983] up to 0.009 part of total L-cysteine per 100 parts of flour in dough as a dough § 184.1278 Diacetyl. strengthener as defined in § 170.3(o)(6) (a) Diacetyl (C H O , CAS Reg. No. of this chapter in yeast-leavened baked 4 6 2 431–03–8) is a clear yellow to yellowish goods and baking mixes as defined in green liquid with a strong pungent § 170.3(n)(1) of this chapter. odor. It is also known as 2,3- (d) This regulation is issued prior to butanedione and is chemically syn- a general evaluation of use of this in- thesized from methyl ethyl ketone. It gredient in order to affirm as GRAS is miscible in water, glycerin, alcohol, the specific use named. and ether, and in very dilute water so- [42 FR 14653, Mar. 15, 1977, as amended at 49 lution, it has a typical buttery odor FR 5612, Feb. 14, 1984] and flavor. (b) The ingredient meets the speci- § 184.1277 Dextrin. fications of the Food Chemicals Codex, (a) Dextrin ((C6H10O5)n·H2O, CAS Reg. 3d Ed. (1981), p. 368, which is incor- No. 9004–53–9) is an incompletely porated by reference. Copies are avail- hydrolyzed starch. It is prepared by dry able from the National Academy Press, heating corn, waxy maize, waxy milo, 2101 Constitution Ave. NW., Wash- potato, arrowroot, wheat, rice, tapioca, ington, DC 20418, or available for in- or sago starches, or by dry heating the spection at the Office of the Federal starches after: (1) Treatment with safe Register, 800 North Capitol Street, and suitable alkalis, acids, or pH con- NW., suite 700, Washington, DC 20408.

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(c) In accordance with § 184.1(b)(1), in this section do not exist or have the ingredient is used in food with no been waived. limitation other than current good [42 FR 14653, Mar. 15, 1977, as amended at 42 manufacturing practice. The affirma- FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, tion of this ingredient as generally rec- 1984; 64 FR 1760, Jan. 12, 1999] ognized as safe (GRAS) as a direct human food ingredient is based upon § 184.1287 Enzyme-modified fats. the following current good manufac- (a) Enzyme-modified refined beef fat, turing practice conditions of use: enzyme-modified butterfat, and en- (1) The ingredient is used as a fla- zyme-modified steam-rendered chicken voring agent and adjuvant as defined in fat are prepared from refined beef fat; § 170.3(o)(12) of this chapter. butterfat or milkfat; and steam-ren- (2) The ingredient is used in food at dered chicken fat, respectively, with levels not to exceed current good man- enzymes that are generally recognized ufacturing practice. as safe (GRAS). Enzyme-modified milk (d) Prior sanctions for this ingredient powder may be prepared with GRAS enzymes from reconstituted milk pow- different from the uses established in der, whole milk, condensed or con- this section do not exist or have been centrated whole milk, evaporated waived. milk, or milk powder. The lipolysis is [48 FR 51907, Nov. 15, 1983] maintained at a temperature that is optimal for the action of the enzyme § 184.1282 Dill and its derivatives. until appropriate acid development is (a) Dill (American or European) is attained. The enzymes are then inac- the herb and seeds from Anethum tivated. The resulting product is concentrated or dried. graveolens L., and dill (Indian) is the (b) FDA is developing food-grade herb and seeds from Anethum sowa, specifications for these enzyme-modi- D.C. Its derivatives include essential fied ingredients in cooperation with oils, oleoresins, and natural extractives the National Academy of Sciences. In obtained from these sources of dill. the interim, the ingredients must be of (b) Dill oils meet the description and purity suitable for their intended use. specifications of the ‘‘Food Chemicals (c) In accordance with § 184.1(b)(1), Codex,’’ 4th ed. (1996), pp. 122–123, which the ingredients are used in food with is incorporated by reference in accord- no limitation other than current good ance with 5 U.S.C. 552(a) and 1 CFR manufacturing practice. The affirma- part 51. Copies are available from the tion of these ingredients as generally National Academy Press, Box 285, 2101 recognized as safe (GRAS) as direct Constitution Ave. NW., Washington, human food ingredients is based upon DC 20055 (Internet address http:// the following current good manufac- www.nap.edu), or may be examined at turing practice conditions of use: the Center for Food Safety and Applied (1) The ingredients are used as fla- Nutrition’s Library, Food and Drug Ad- voring agents and adjuvants as defined ministration, 5100 Paint Branch Pkwy., in § 170.3(o)(12) of this chapter. College Park, MD 20740, or at the Office (2) The ingredients are used in food of the Federal Register, 800 North Cap- at levels not to exceed current good itol St. NW., suite 700, Washington, DC. manufacturing practice. (c) Dill and its derivatives are used as (d) Prior sanctions for these ingredients different from the uses established flavoring agents and adjuvants as de- in this section do not exist or have fined in § 170.3(o)(12) of this chapter. been waived. (d) The ingredients are used in food at levels not to exceed good manufac- [52 FR 25976, July 10, 1987] turing practice. § 184.1293 Ethyl alcohol. (e) [Reserved] (f) Prior sanctions for these ingredi- (a) Ethyl alcohol (ethanol) is the ents different from the uses established chemical C2H5OH. (b) The ingredient meets the specifications of the ‘‘Food Chemicals

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Codex,’’ 4th ed. (1996), p. 136, which is goods as defined in § 170.3(n)(1) of this incorporated by reference in accord- chapter; 0.04 percent in chewing gum as ance with 5 U.S.C. 552(a) and 1 CFR defined in § 170.3(n)(6), hard candy as part 51. Copies are available from the defined in § 170.3(n)(25), and soft candy National Academy Press, Box 285, 2101 as defined in § 170.3(n)(38) of this chap- Constitution Ave. NW., Washington, ter; 0.02 percent in frozen dairy des- DC 20055 (Internet address http:// serts as defined in § 170.3(n)(20) of this www.nap.edu), or may be examined at chapter; 0.03 percent in gelatins, pud- the Center for Food Safety and Applied dings, and fillings as defined in Nutrition’s Library, Food and Drug Ad- § 170.3(n)(22) of this chapter; and 0.01 ministration, 5100 Paint Branch Pkwy., percent in all other food categories. College Park, MD 20740, or at the Office (e) Prior sanctions for ethyl formate of the Federal Register, 800 North Cap- different from the uses established in itol St. NW., suite 700, Washington, DC. this section do not exist or have been (c) The ingredient is used as an anti- waived. microbial agent as defined in § 170.3(o)(2) of this chapter on pizza [45 FR 22915, Apr. 4, 1980, as amended at 49 crusts prior to final baking at levels FR 5612, Feb. 14, 1984] not to exceed 2.0 percent by product weight. § 184.1296 Ferric ammonium citrate. (d) This regulation is issued prior to (a) Ferric ammonium citrate (iron general evaluation of use of this ingre- (III) ammonium citrate) is prepared by dient in order to affirm as GRAS the the reaction of ferric hydroxide with specific use named. citric acid, followed by treatment with [42 FR 14653, Mar. 15, 1977, as amended at 49 ammonium hydroxide, evaporating, FR 5612, Feb. 14, 1984; 64 FR 1760, Jan. 12, and drying. The resulting product oc- 1999] curs in two forms depending on the stoichiometry of the initial reactants. § 184.1295 Ethyl formate. (1) Ferric ammonium citrate (iron (a) Ethyl formate (C3H6O2, CAS Reg. (III) ammonium citrate, CAS Reg. No. No. 109–94–4) is also referred to as ethyl 1332–98–5) is a complex salt of undeter- methanoate. It is an ester of formic mined structure composed of 16.5 to acid and is prepared by esterification 18.5 percent iron, approximately 9 per- of formic acid with ethyl alcohol or by cent ammonia, and 65 percent citric distillation of ethyl acetate and formic acid and occurs as reddish brown or acid in the presence of concentrated garnet red scales or granules or as a sulfuric acid. Ethyl formate occurs brownish-yellowish powder. naturally in some plant oils, fruits, and (2) Ferric ammonium citrate (iron juices but does not occur naturally in the animal kingdom. (III) ammonium citrate, CAS Reg. No. (b) The ingredient meets the speci- 1333–00–2) is a complex salt of undeter- fications of the ‘‘Food Chemicals mined structure composed of 14.5 to 16 Codex,’’ 3d Ed. (1981), p. 376, which is in- percent iron, approximately 7.5 percent corporated by reference. Copies may be ammonia, and 75 percent citric acid obtained from the National Academy and occurs as thin transparent green Press, 2101 Constitution Ave. NW., scales, as granules, as a powder, or as Washington, DC 20418, or may be exam- transparent green crystals. ined at the Office of the Federal Reg- (b) The ingredients meet the speci- ister, 800 North Capitol Street, NW., fications of the Food Chemicals Codex, suite 700, Washington, DC 20408. 3d Ed. (1981), pp. 116–117 (Ferric ammo- (c) The ingredient is used as a fla- nium citrate, brown) and p. 117 (Ferric voring agent and adjuvant as defined in ammonium citrate, green), which is in- § 170.3(o)(12) of this chapter. corporated by reference. Copies are (d) The ingredient is used in food at available from the National Academy levels not to exceed good manufac- Press, 2101 Constitution Ave. NW., turing practice in accordance with Washington, DC 20418, or available for § 184.1(b)(1). Current good manufac- inspection at the Office of the Federal turing practice results in a maximum Register, 800 North Capitol Street, level, as served, of 0.05 percent in baked NW., suite 700, Washington, DC 20408.

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(c) In accordance with § 184.1(b)(1), with the National Academy of the ingredients are used in food as nu- Sciences. In the interim, this ingre- trient supplements as defined in dient must be of a purity suitable for § 170.3(o)(20) of this chapter, with no its intended use. limitation other than current good (c) In accordance with § 184.1(b)(1), manufacturing practice. The ingredi- the ingredient is used in food as a nu- ents may also be used in infant formula trient supplement as defined in in accordance with section 412(g) of the § 170.3(o)(20) of this chapter, with no Federal Food, Drug, and Cosmetic Act limitation other than current good (the act) (21 U.S.C. 350a(g)) or with reg- manufacturing practice. The ingre- ulations promulgated under section dient may also be used in infant for- 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). mula in accordance with section 412(g) (d) Prior sanctions for these ingredi- of the Federal Food, Drug, and Cos- ents different from the uses established metic Act (the act) (21 U.S.C. 350a(g)) in this section do not exist or have or with regulations promulgated under been waived. section 412(a)(2) of the act (21 U.S.C. [53 FR 16864, May 12, 1988] 350a(a)(2)). (d) Prior sanctions for this ingredient § 184.1297 Ferric chloride. different from the uses established in (a) Ferric chloride (iron (III) chlo- this section do not exist or have been waived. ride, FeC13, CAS Reg. No. 7705–08–0) may be prepared from iron and chlorine [53 FR 16865, May 12, 1988] or from ferric oxide and hydrogen chloride. The pure material occurs as § 184.1301 Ferric phosphate. hydroscopic, hexagonal, dark crystals. (a) Ferric phosphate (ferric Ferric chloride hexahydrate (iron (III) orthophosphate, iron (III) phosphate, chloride hexahydrate, FeC13. 6H20, CAS FePO4·xH2O, CAS Reg. No. 10045–86–0) is Reg. No. 10025–77–1) is readily formed an odorless, yellowish-white to buff- when ferric chloride is exposed to mois- colored powder and contains from one ture. to four molecules of water of hydra- (b) The Food and Drug Administra- tion. It is prepared by reaction of so- tion is developing food-grade specifica- dium phosphate with ferric chloride or tions for ferric chloride in cooperation ferric citrate. with the National Academy of (b) The ingredient meets the speci- Sciences. In the interim, this ingre- fications of the Food Chemicals Codex, dient must be of a purity suitable for 3d Ed. (1981), pp. 118–120, which is incor- its intended use. porated by reference. Copies are avail- (c) In accordance with § 184.1(b)(1) the able from the National Academy Press, ingredient is used in food as a flavoring 2101 Constitution Ave. NW., Wash- agent as defined in § 170.3(o)(12) of this ington, DC 20418, or available for in- chapter, with no limitation other than spection at the Office of the Federal current good manufacturing practice. Register, 800 North Capitol Street, (d) Prior sanctions for this ingredient NW., suite 700, Washington, DC 20408. different from the uses established in (c) In accordance with § 184.1(b)(1), this section do not exist or have been the ingredient is used in food as nutri- waived. ent supplement as defined in [53 FR 16864, May 12, 1988] § 170.3(o)(20) of this chapter, with no limitation other than current good § 184.1298 Ferric citrate. manufacturing practice. The ingre- (a) Ferric citrate (iron (III) citrate, dient may also be used in infant for- C6H5FeO7, CAS Reg. No. 2338–05–8) is mula in accordance with section 412(g) prepared from reaction of citric acid of the Federal Food, Drug, and Cos- with ferric hydroxide. It is a compound metic Act (the act) (21 U.S.C. 350a(g)) of indefinite ratio of citric acid and or with regulations promulgated under iron. section 412(a)(2) of the act (21 U.S.C. (b) The Food and Drug Administra- 350a(a)(2)). tion is developing food-grade specifica- (d) Prior sanctions for this ingredient tions for ferric citrate in cooperation different from the uses established in

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this section do not exist or have been of this chapter, with no limitation waived. other than current good manufacturing practice. [53 FR 16865, May 12, 1988] (d) Prior sanctions for this ingredient § 184.1304 Ferric pyrophosphate. different from the uses established in this section do not exist or have been (a) Ferric pyrophosphate (iron (III) waived. pyrophosphate, Fe4(P207)3·xH2O, CAS Reg. No. 10058–44–3) is a tan or yel- [53 FR 16865, May 12, 1988] lowish white colorless powder. It is prepared by reacting sodium § 184.1307a Ferrous ascorbate. pyrophosphate with ferric citrate. (a) Ferrous ascorbate (CAS Reg. No. (b) The ingredient meets the speci- 14536–17–5) is a reaction product of fer- fications of the Food Chemicals Codex, rous hydroxide and ascorbic acid. It is 3d Ed. (1981), p. 120, which is incor- a blue-violet product containing 16 per- porated by reference. Copies are avail- cent iron. able from the National Academy Press, (b) The Food and Drug Administra- 2101 Constitution Ave. NW., Wash- tion is developing food-grade specifica- ington, DC 20418, or available for in- tions for ferrous ascorbate in coopera- spection at the Office of the Federal tion with the National Academy of Register, 800 North Capitol Street, Sciences. In the interim, this ingre- NW., suite 700, Washington, DC 20408. dient must be of a purity suitable for (c) In accordance with § 184.1(b)(1), its intended use. the ingredient is used in food as a nu- (c) In accordance with § 184.1(b)(1), trient supplement as defined in the ingredient is used in food as a nu- § 170.3(o)(20) of this chapter, with no trient supplement as defined in limitation other than current good § 170.3(o)(20) of this chapter, with no manufacturing practice. The ingre- limitation other than current good dient may also be used in infant for- manufacturing practice. The ingre- mula in accordance with section 412(g) dient may also be used in infant for- of the Federal Food, Drug, and Cos- mula in accordance with section 412(g) metic Act (the act) (21 U.S.C. 350a(g)) of the Federal Food, Drug, and Cos- or with regulations promulgated under metic Act (the act) (21 U.S.C. 350a(g)) section 412(a)(2) of the act (21 U.S.C. or with regulations promulgated under 350a(a)(2)). section 412(a)(2) of the act (21 U.S.C. (d) Prior sanctions for this ingredient 350a(a)(2)). different from the uses established in (d) Prior sanctions for this ingredient this section do not exist or have been different from the uses established in waived. this section do not exist or have been waived. [53 FR 16865, May 12, 1988; 53 FR 20939, June 7, 1988] [53 FR 16865, May 12, 1988]

§ 184.1307 Ferric sulfate. § 184.1307b Ferrous carbonate. (a) Ferric sulfate (iron (III) sulfate, (a) Ferrous carbonate (iron (II) car- Fe2(SO4)3, CAS Reg. No. 10028–22–5) is a bonate, FeCO3, CAS Reg. No. 563–71–3) yellow substance that may be prepared is an odorless, white solid prepared by by oxidizing iron (II) sulfate or by treating solutions of iron (II) salts with treating ferric oxide or ferric hydrox- alkali carbonate salts. ide with sulfuric acid. (b) The Food and Drug Administra- (b) The Food and Drug Administra- tion is developing food-grade specification is developing food-grade specifications for ferrous carbonate in coopera- tions for ferric sulfate in cooperation tion with the National Academy of with the National Academy of Sciences. In the interim, this ingre- Sciences. In the interim, this ingredient must be of a purity suitable for dient must be of a purity suitable for its intended use. its intended use. (c) In accordance with § 184.1(b)(1), (c) In accordance with § 184.1(b)(1), the ingredient is used in food as a nu- the ingredient is used in food as a fla- trient supplement as defined in voring agent as defined in § 170.3(o)(12) § 170.3(o)(20) of this chapter, with no

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limitation other than current good (b) The ingredient meets the speci- manufacturing practice. The ingre- fications of the Food Chemicals Codex, dient may also be used in infant for- 3d Ed. (1981), pp. 120–122, which is incor- mula in accordance with section 412(g) porated by reference. Copies are avail- of the Federal Foods, Drug, and Cos- able from the National Academy Press, metic Act (the act) (21 U.S.C. 350a(g)) 2101 Constitution Ave NW., Wash- or with regulations promulgated under ington, DC 20418, or available for in- section 412(a)(2) of the act (21 U.S.C. spection at the Office of the Federal 350a(a)(2)). Register, 800 North Capitol Street, (d) Prior sanctions for this ingredient NW., suite 700, Washington, DC 20408. different from the uses established in (c) In accordance with § 184.1(b)(1) the this section do not exist or have been ingredient is used in food as a nutrient waived. supplement as defined in § 170.3(o)(20) of this chapter, with no limitation other [53 FR 16865, May 12, 1988] than current good manufacturing practice. The ingredient may also be used § 184.1307c Ferrous citrate. in infant formula in accordance with (a) Ferrous citrate (iron (II) citrate, section 412(g) of the Federal Food, (C6H6FeO7), CAS Reg. No. 23383–11–1) is Drug, and Cosmetic Act (the act) (21 a slightly colored powder or white U.S.C. 350a(g)), or with regulations pro- crystals. It is prepared from the reac- mulgated under section 412(a)(2) of the tion of sodium citrate with ferrous sul- act (21 U.S.C. 350a(a)(2)). fate or by direct action of citric acid on (d) Prior sanctions for this ingredient iron filings. different from the uses established in (b) The Food and Drug Administra- this section do not exist or have been tion is developing food-grade specifica- waived. tions for ferrous citrate in cooperation [53 FR 16866, May 12, 1988] with the National Academy of Sciences. In the interim, this ingre- § 184.1308 Ferrous gluconate. dient must be of a purity suitable for (a) Ferrous gluconate (iron (II) gluco- its intended use. nate dihydrate, C12H22FeO14·2H2O, CAS (c) In accordance with § 184.1(b)(1) the Reg. No. 6047-12-7) is a fine yellowish- ingredient is used in food as a nutrient gray or pale greenish-yellow powder or supplement as defined in § 170.3(o)(20) of granules. It is prepared by reacting hot this chapter, with no limitation other solutions of barium or calcium gluco- than current good manufacturing prac- nate with ferrous sulfate or by heating tice. The ingredient may also be used freshly prepared ferrous carbonate with in infant formula in accordance with gluconic acid in aqueous solution. section 412(g) of the Federal Food, (b) The ingredient meets the speci- Drug, and Cosmetic Act (the act) (21 fications of the Food Chemcials Codex, U.S.C. 350a(g)) or with regulations pro- 3d Ed. (1981), pp. 122–123, which is incor- mulgated under section 412(a)(2) of the porated by reference. Copies are avail- act (21 U.S.C. 350a(a)(2)). able from the National Academy Press, (d) Prior sanctions for this ingredient 2101 Constitution Avenue NW., Wash- different from the uses established in ington, DC 20418, or available for in- this section do not exist or have been spection at the Office of the Federal waived. Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [53 FR 16866, May 12, 1988] (c) In accordance with § 184.1(b)(1), the ingredient is used in food as a nu- § 184.1307d Ferrous fumarate. trient supplement as defined in (a) Ferrous fumarate (iron (II) fuma- § 170.3(o)(20) of this chapter, with no rate, (C4H2FeO4), CAS Reg. No. 141–01–5) limitation other than current good is an odorless, reddish-orange to red- manufacturing practice. The ingre- dish-brown powder. It may contain soft dient may also be used in infant for- lumps that produce a yellow streak mula in accordance with section 412(g) when crushed. It is prepared by of the Federal Food, Drug, and Cos- admixing hot solutions of ferrous sul- metic Act (the act) (21 U.S.C. 350a(g)) fate and sodium fumarate. or with regulations promulgated under

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section 412(a)(2) of the act (21 U.S.C. FeSO4·7H2O, CAS Reg. No. 7782–63–0) is 350a(a)(2)). prepared by the action of sulfuric acid (d) Prior sanctions for this ingredient on iron. It occurs as pale, bluish-green different from the uses established in crystals or granules. Progressive heat- this section do not exist or have been ing of ferrous sulfate heptahydrate pro- waived. duces ferrous sulfate (dried). Ferrous sulfate (dried) consists primarily of fer- [53 FR 16866, May 12, 1988; 53 FR 20939, June rous sulfate monohydrate (CAS Reg. 7, 1988] No. 17375–41–6) with varying amounts of § 184.1311 Ferrous lactate. ferrous sulfate tetrahydrate (CAS Reg. No. 20908–72–9) and occurs as a grayish- (a) Ferrous lactate (iron (II) lactate, white to buff-colored powder. C6H10FeO6, CAS Reg. No. 5905–52–2) in (b) The ingredients meet the speci- the trihydrate form is a greenish-white fications of the Food Chemicals Codex, powder or crystalline mass. It is pre- 3d Ed. (1981), p. 123 (Ferrous sulfate pared by reacting calcium lactate or heptahydrate) and p. 124 (ferrous sul- sodium lactate with ferrous sulfate, di- fate, dried), which is incorporated by rect reaction of lactic acid with iron reference. Copies are available from filings, reaction of ferrous chloride the National Academy Press, 2101 Con- with sodium lactate, or reaction of fer- stitution Ave., NW., Washington, DC rous sulfate with ammonium lactate. 20418, or available for inspection at the (b) The ingredient meets the speci- Office of Federal Register, 800 North fications of the Food Chemicals Codex, Capitol Street, NW., suite 700, Wash- 4th ed. (1996), pp. 154 to 155, which is in- ington, DC 20408. corporated by reference in accordance (c) In accordance with § 184.1(b)(1), with 5 U.S.C. 552(a) and 1 CFR part 51. the ingredients are used in food as nu- Copies are available from the National trient supplements as defined in Academy Press, 2101 Constitution Ave. § 170.3(o)(20) of this chapter and as a NW., Washington, DC 20418, or may be processing aid as defined in § 170.3(o)(24) examined at the Center for Food Safety of this chapter, with no limitation and Applied Nutrition’s library, 5100 other than current good manufacturing Paint Branch Pkwy., College Park, MD practice. The ingredients may also be 20740, or at the Office of the Federal used in infant formula in accordance Register, 800 North Capitol St. NW., with section 412(g) of the Federal Food, suite 700, Washington, DC. Drug, and Cosmetic Act (the act) (21 (c) In accordance with § 184.1(b)(1), U.S.C. 350a(g)) or with regulations pro- the ingredient is used in food as a nu- mulgated under section 412(a)(2) of the trient supplement as defined in act (21 U.S.C. 350a(a)(2)). § 170.3(o)(20) of this chapter and as a (d) Prior sanctions for these ingredi- color fixative for ripe olives, with no ents different from the uses established other limitation other than current in this section do not exist or have good manufacturing practice. The in- been waived. gredient may also be used in infant for- [53 FR 16866, May 12, 1988] mula in accordance with section 412(g) of the Federal Food, Drug, and Cos- § 184.1316 Ficin. metic Act (the act) (21 U.S.C. 350a(g)) (a) Ficin (CAS Reg. No. 9001–33–6) is or with regulations promulgated under an enzyme preparation obtained from section 412(a)(2) of the act (21 U.S.C. the latex of species of the genus Ficus, 350a(a)(2)). which include a variety of tropical fig (d) Prior sanctions for this ingredient trees. It is a white to off-white powder. different from the uses established in Its characterizing enzyme activity is this section do not exist or have been that of a peptide hydrolase (EC waived. 3.4.22.3). [53 FR 16866, May 12, 1988, as amended at 61 (b) The ingredient meets the general FR 40319, Aug. 2, 1996] requirements and additional requirements for enzyme preparations in the § 184.1315 Ferrous sulfate. Food Chemicals Codex, 3d ed. (1981), p. (a) Ferrous sulfate heptahydrate 110, which is incorporated by reference (iron (II) sulfate heptahydrate, in accordance with 5 U.S.C. 552(a) and 1

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CFR part 51. Copies are available from § 184.1318 Glucono delta-lactone. the National Academy Press, 2101 Con- (a) Glucono delta-lactone (C H O , stitution Ave., NW., Washington, DC 6 10 6 CAS Reg. No. 90–80–2), also called D- 20418, or may be examined at the Office of Premarket Approval (HFS–200), Food gluconic acid delta-lactone or D- and Drug Administration, 5100 Paint glucono-1,5-lactone, is the cyclic 1,5- Branch Pkwy., College Park, MD 20740, intramolecular ester of D-gluconic and the Office of the Federal Register, acid. It is prepared by direct crys- 800 North Capitol St., NW., suite 700, tallization from the aqueous solution Washington, DC. of gluconic acid. Gluconic acid may be (c) In accordance with § 184.1(b)(1), produced by the oxidation of D-glucose the ingredient is used in food with no with bromine water, by the oxidation limitation other than current good of D-glucose by microorganisms that manufacturing practice. The affirma- are nonpathogenic and nontoxicogenic tion of this ingredient as GRAS as a di- to man or other animals, or by the oxi- rect food ingredient is based upon the dation of D-glucose with enzymes de- following current good manufacturing rived from these microorganisms. practice conditions of use: (b) The ingredient meets the speci- (1) The ingredient is used as an en- fications of the Food Chemicals Codex, zyme as defined in § 170.3(o)(9) of this 3d Ed. (1981), p. 134, which is incor- chapter to hydrolyze proteins or porated by reference. Copies are avail- polypeptides. able from the National Academy Press, (2) The ingredient is used in food at 2101 Constitution Ave. NW., Wash- levels not to exceed current good man- ington, DC 20418, or available for in- ufacturing practice. spection at the Office of the Federal Register, 800 North Capitol Street, [60 FR 32910, June 26, 1995] NW., suite 700, Washington, DC 20408. (c) In accordance with § 184.1(b)(1), § 184.1317 Garlic and its derivatives. the ingredient is used in food with no (a) Garlic is the fresh or dehydrated limitation other than current good bulb or cloves obtained from Allium manufacturing practice. The affirma- sativum, a genus of the lily family. Its tion of this ingredient as generally rec- derivatives include essential oils, oleo- ognized as safe (GRAS) as a direct resins, and natural extractives ob- human food ingredient is based upon tained from garlic. the following current good manufac- (b) Garlic oil meets the specifications turing practice conditions of use: of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1) The ingredient is used as a curing (1981), p. 132, which is incorporated by and pickling agent as defined in reference. Copies may be obtained from § 170.3(o)(5) of this chapter, leavening the National Academy Press, 2101 Con- agent as defined in § 170.3(o)(17) of this stitution Ave. NW., Washington, DC chapter; pH control agent as defined in 20418, or may be examined at the Office § 170.3(o)(23) of this chapter; and of the Federal Register, 800 North Cap- sequestrant as defined in § 170.3(o)(26) of itol Street, NW., suite 700, Washington, this chapter. DC 20408. (2) The ingredient is used at levels (c) Garlic and its derivatives are used not to exceed current good manufac- as flavoring agents and adjuvants as turing practice. defined in § 170.3(o)(12) of this chapter. (d) Prior sanctions for this ingredient (d) The ingredients are used in food different from the uses established in at levels not to exceed good manufac- this section do not exist or have been turing practice. waived. (e) [Reserved] (f) Prior sanctions for this ingredient [51 FR 33896, Sept. 24, 1986] different from the uses established in this section do not exist or have been § 184.1321 Corn gluten. waived. (a) Corn gluten (CAS Reg. No. 66071– [42 FR 14653, Mar. 15, 1977, as amended at 42 96–3), also known as corn gluten meal, FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, is the principal protein component of 1984] corn endosperm. It consists mainly of

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zein and glutelin. Corn gluten is a by- ognized as safe (GRAS) as a direct product of the wet milling of corn for human food ingredient is based upon starch. The gluten fraction is washed the following current good manufac- to remove residual water soluble pro- turing practice conditions of use: teins. Corn gluten is also produced as a (1) The ingredient is used as a dough byproduct during the conversion of the strengthener as defined in § 170.3(o)(6) starch in whole or various fractions of of this chapter; a formulation aid as dry milled corn to corn syrups. defined in § 170.3(o)(14) of this chapter; (b) FDA is developing food-grade a nutrient supplement as defined in specifications for corn gluten in co- § 170.3(o)(20) of this chapter; a proc- operation with the National Academy essing aid as defined in § 170.3(o)(24) of of Sciences. In the interim, the ingre- this chapter; a stabilizer and thickener dient must be of a purity suitable for as defined in § 170.3(o)(28) of this chap- its intended use. ter; a surface-finishing agent as defined (c) In accordance with § 184.1(b)(1), in § 170.3(o)(30) of this chapter; and a the ingredient is used in food with no texturizing agent as defined in limitation other than current good § 170.3(o)(32) of this chapter. manufacturing practice. The affirma- (2) The ingredient is used in food at tion of this ingredient as generally rec- levels not to exceed current good man- ognized as safe (GRAS) as a direct ufacturing practice. human food ingredient is based upon (d) Prior sanctions for this ingredient the following current good manufac- different from the uses established in turing practice conditions of use: this section do not exist or have been (1) The ingredient is used as a nutri- waived. ent supplement as defined in [50 FR 8998, Mar. 6, 1985] § 170.3(o)(20) of this chapter and a texturizer as defined in § 170.3(o)(32) of § 184.1323 Glyceryl monooleate. this chapter. (a) Glyceryl monooleate is prepared (2) The ingredient is used in food at by esterification of commerical oleic levels not to exceed current good man- acid that is derived either from edible ufacturing practice. (d) Prior sanctions for this ingredient sources or from tall oil fatty acids different from the uses established in meeting the requirements of § 172.862 of this section do not exist or have been this chapter. It contains glyceryl waived. monooleate (C21H40O4, CAS Reg. No. 25496–72–4) and glyceryl esters of fatty [50 FR 8998, Mar. 6, 1985] acids present in commercial oleic acid. (b) FDA is developing food-grade § 184.1322 Wheat gluten. specifications for glyceryl monooleate (a) Wheat gluten (CAS Reg. No. 8002– in cooperation with the National Acad- 80–0) is the principal protein compo- emy of Sciences. In the interim, this nent of wheat and consists mainly of ingredient must be of a purity suitable gliadin and glutenin. Wheat gluten is for its intended use. obtained by hydrating wheat flour and (c) In accordance with § 184.1(b)(1), mechanically working the sticky mass the ingredient is used in food with no to separate the wheat gluten from the limitation other than current good starch and other flour components. manufacturing practice. The affirma- Vital gluten is dried gluten that has re- tion of this ingredient as generally rec- tained its elastic properties. ognized as safe (GRAS) as a direct (b) FDA is developing food-grade human food ingredient is based upon specifications for wheat gluten in co- the following current good manufac- operation with the National Academy turing practice conditions of use: of Sciences. In the interim, the ingre- (1) The ingredient is used as a fla- dient must be of a purity suitable for voring agent and adjuvant as defined in its intended use. § 170.3(o)(12) of this chapter and as a (c) In accordance with § 184.1(b)(1), solvent and vehicle as defined in the ingredient is used in food with no § 170.3(o)(27) of this chapter. limitation other than current good (2) The ingredient is used in the fol- manufacturing practice. The affirma- lowing foods at levels not to exceed tion of this ingredient as generally rec- current good manufacturing practice:

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baked goods and baking mixes as de- (2) Behenic acid. Between 80 and 90 fined in § 170.3(n)(1) of this chapter; percent of the total fatty acid content. nonalcoholic beverages and beverage (3) Acid value. Not more than 4. bases as defined in § 170.3(n)(3) of this (4) Saponification value. Between 145 chapter; chewing gum as defined in and 165. § 170.3(n)(6) of this chapter; and meat (5) Iodine number. Not more than 3. products as defined in § 170.3(n)(29) of (6) Heavy metals (as Pb). Not more this chapter. than 10 parts per million. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1) of different from the use established in this chapter, the ingredient is used in this section do not exist or have been waived. food with no limitation other than current good manufacturing practice. The [54 FR 7403 Feb. 21, 1989] affirmation of this ingredient is generally recognized as safe (GRAS) as a § 184.1324 Glyceryl monostearate. direct human food ingredient is based (a) Glyceryl monostearate, also upon the following current good manu- known as monostearin, is a mixture of facturing practice conditions of use: variable proportions of glyceryl mono- (1) The ingredient is used as a formu- stearate (C21H42O4, CAS Reg. No. 31566– lation aid, as defined in § 170.3(o)(14) of 31–1), glyceryl monopalmitate this chapter. (C19H38O4, CAS Reg. No. 26657–96–5) and (2) The ingredient is used in excipient glyceryl esters of fatty acids present in formulations for use in tablets at levels commercial stearic acid. Glyceryl not to exceed good manufacturing monostearate is prepared by practice. glycerolysis of certain fats or oils that are derived from edible sources or by [52 FR 42430, Nov. 5, 1987] esterification, with glycerin, of stearic acid that is derived from edible § 184.1329 Glyceryl palmitostearate. sources. (a) Glyceryl palmitostearate is a (b) FDA is developing food-grade mixture of mono-, di-, and triglyceryl specifications for glyceryl monostea- esters of palmitic and stearic acids rate in cooperation with the National made from glycerin, palmitic acid, and Academy of Sciences. In the interim, stearic acid. this ingredient must be of a purity (b) The ingredient meets the fol- suitable for its intended use. lowing specifications: (c) In accordance with § 184.1(b)(1), (1) The substance is a mixture of the ingredient is used in food with no mono-, di-, and triglycerides of pal- limitation other than current good mitic acid and stearic acid. manufacturing practice. (d) Prior sanctions for this ingredient (2) Heavy metals (as lead): Not more different from the uses established in than 10 parts per million. this section do not not exist or have (c) In accordance with § 184.1(b)(1), been waived. the ingredient is used in food with no limitation other than current good [54 FR 7403 Feb. 21, 1989] manufacturing practice. The affirmation of this ingredient as generally rec- § 184.1328 Glyceryl behenate. ognized as safe (GRAS) as a direct (a) Glyceryl behenate is a mixture of human food ingredient is based upon glyceryl esters of behenic acid made the following current good manufac- from glycerin and behenic acid (a satu- turing practice conditions of use: rated C22 fatty acid). The mixture con- (1) The ingredient is used as a formu- tains predominately glyceryl lation aid, as defined in § 170.3(o)(14) of dibehenate. this chapter. (b) The ingredient meets the fol- (2) The ingredient is used in excipient lowing specifications: formulations for use in tablets at levels (1) 10 to 20 percent monoglyceride, 47 not to exceed good manufacturing to 59 percent diglyceride, 26 to 38 per- practice. cent triglyceride, and not more than 2.5 percent free fatty acids. [60 FR 63621, Dec. 12, 1995]

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§ 184.1330 Acacia (gum arabic). corporated by reference. Copies may be obtained from the National Academy (a) Acacia (gum arabic) is the dried Press, 2101 Constitution Ave. NW., gummy exudate from stems and Washington, DC 20418, or may be exam- branches of trees of various species of ined at the Office of the Federal Reg- the genus Acacia, family Leguminosae. ister, 800 North Capitol Street, NW., (b) The ingredient meets the speci- suite 700, Washington, DC 20408. fications of the ‘‘Food Chemicals (c) The ingredient is used in food Codex,’’ 3d Ed. (1981), p. 7, which is in- under the following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Beverages and beverage bases, § 170.3(n)(3) of this 2.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; chapter. flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Chewing gum, § 170.3(n)(6) of this chapter ...... 5.6 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; humectant, § 170.3(o)(16) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chapter. Confections and frostings, § 170.3(n)(9) of this chap- 12.4 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and ter. thickener, § 170.3(o)(28) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chapter. Dairy product analogs, § 170.3(n)(10) of this chapter 1.3 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Fats and oils, § 170.3(n)(12) of this chapter ...... 1.5 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Gelatins, puddings, and fillings, § 170.3(n)(22) of this 2.5 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; chapter. formulation aid, § 170.3(o)(14) of this chapter.; stabilizer and thickener, § 170.3(o)(28) of this chapter. Hard candy and cough drops, § 170.3(n)(25) of this 46.5 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; chapter. formulation aid, § 170.3(o)(14) of this chapter. Nuts and nut products, § 170.3(n)(32) of this chapter 8.3 Formulation aid, § 170.3(o)(14) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chapter. Quiescently frozen confection products ...... 6.0 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Snack foods, §170.3(n)(37) of this chapter ...... 4.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; formulation aid, § 170.3(o)(14) of this chapter. Soft candy, §170.3(n)(38) of this chapter ...... 85.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; firming agent, § 170.3(o)(10) of this chapter; flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter, humectant, § 170.3(o)(16) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chapter. All other food categories ...... 1.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; processing aid, § 170.3(o)(24) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chapter; texturizer, § 170.3(o)(32) of this chapter.

(d) [Reserved] Anogeissus latifolia, a large tree found (e) Prior sanctions for this ingredient in the dry deciduous forests of India different from the uses established in and Ceylon. this section do not exist or have been (b) The ingredient complies with the waived. following specifications: [42 FR 14653, Mar. 15, 1977, as amended at 42 (1) Viscosity of a 1-percent solution. FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, Not less than the minimum or within 1983; 53 FR 5766, Feb. 26, 1988] the range claimed by the vendor. (2) Limits of impurities—(i) Arsenic (as § 184.1333 Gum ghatti. AL). Not more than 3 parts per million (a) Gum ghatti (Indian gum) is an (0.0003 percent); exudate from wounds in the bark of

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(ii) Ash (acid-insoluble). Not more corporated by reference (copies are than 1.75 percent; available from the Association of Offi- (iii) Ash (total). Not more than 6.0 cial Analytical Chemists, P.O. Box 540, percent; Benjamin Franklin Station, Wash- (iv) Heavy metals (as Pb). Not more ington, DC 20044, or may be examined than 40 parts per million (0.004 per- at the Office of the Federal Register, cent); and 800 North Capitol Street, NW., suite (v) Lead. Not more than 10 parts per 700, Washington, DC 20408), to 5 ml of a million (0.001 percent). cold 1-in-100 aqueous solution of the (3) Loss on drying. Not more than 14 gum. An immediate, voluminous, percent dried at 105 °C for 5 hours. opaque precipitate indicates acacia. A (4) Identification test. Add 0.2 ml of di- small precipitate or clear solution luted lead acetate as outlined in ‘‘Offi- which produces an opaque flocculent cial Methods of Analysis of the Asso- precipitate upon the additon of 1 ml of ciation of Official Analytical Chem- 3 N ammonimum hydroxide indicates ists,’’ 13th Ed. (1980), section 31.178(b), gum ghatti. p. 529, under ‘‘Dilute Basic Lead Ace- (c) The ingredient is used in food tate Standard Solution,’’ which is in- under the following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Beverages and beverage bases, nonalcoholic, 0.2 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter. § 170.3(n)(3) of this chapter. All other food categories ...... 1 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter.

(d) Prior sanctions for this ingredient (b) The ingredient meets the speci- different from the uses established in fications of the ‘‘Food Chemicals this section do not exist or have been Codex,’’ 3d Ed. (1981), p. 141, which is in- waived. corporated by reference. Copies may be [42 FR 14653, Mar. 15, 1977, as amended at 49 obtained from the National Academy FR 5612, Feb. 14, 1984] Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be exam- § 184.1339 Guar gum. ined at the Office of the Federal Reg- (a) Guar gum is the natural sub- ister, 800 North Capitol Street, NW., stance obtained from the maceration of suite 700, Washington, DC 20408. the seed of the guar plant, Cyamopsis (c) The ingredient is used in food tetragonoloba (Linne) Taub., or under the following conditions: Cyamopsis psoraloides (Lam.) D.C.

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Baked goods and baking mixes, § 170.3(n)(1) of this 0.35 Emulsifier and emulsifier salts, § 170.3(o)(8) of this chapter; chapter. formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener; § 170.3(o)(28) of this chapter. Breakfast cereals, § 170.3(n)(4) of this chapter ...... 1.2 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Cheese, § 170.3(n)(5) of this chapter ...... 8 Do. Dairy products analogs, § 170.3(n)(10) of this chap- 1.0 Firming agent, § 170.3(o)(10) of this chapter; formulation ter. aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Fats and oils, § 170.3(n)(12) of this chapter ...... 2.0 Do. Gravies and sauces, § 170.3(n)(24) of this chapter .. 1.2 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Jams and jellies, commercial, § 170.3(n)(28) of this 1.0 Do. chapter. Milk products, § 170.3(n)(31) of this chapter ...... 6 Do. Processed vegetables and vegetable juices, 2.0 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and § 170.3(n)(36) of this chapter. thickener, § 170.3(o)(28) of this chapter. Soups and soup mixes, § 170.3(n)(40) of this chap- .8 Do. ter.

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MAXIMUM USAGE LEVELS PERMITTED—Continued

Food (as served) Percent Function

Sweet sauces, toppings and syrups, § 170.3(n)(43) 1.0 Do. of this chapter. All other food categories ...... 5 Emulsifier and emulsifier salts, § 170.3(o)(8) of this chapter; firming agent, § 170.3(o)(10) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter.

(d) [Reserved] evergreen tree, with lesser quantities (e) Prior sanctions for this ingredient of seed coat and germ. different from the uses established in (b) The ingredient meets the speci- this section do not exist or have been fications of the ‘‘Food Chemicals waived. Codex,’’ 3d Ed. (1981), pp. 174–175, which is incorporated by reference. Copies [42 FR 14653, Mar. 15, 1977, as amended at 42 may be obtained from the National FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, Academy Press, 2101 Constitution Ave. 1984] NW., Washington, DC 20418, or may be examined at the Office of the Federal § 184.1343 Locust (carob) bean gum. Register, 800 North Capitol Street, (a) Locust (carob) bean gum is pri- NW., suite 700, Washington, DC 20408. marily the macerated endosperm of the (c) The ingredient is used at levels seed of the locust (carob) bean tree, not to exceed the following maximum Ceratonia siliqua (Linne), a leguminous levels:

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Baked goods and baking mixes, § 170.3(n)(1) of this 0.15 Stabilizer and thickener, § 170.3(o)(28) of this chapter. chapter. Beverages and beverage bases, nonalcoholic, .25 Do. § 170.3(n)(3) of this chapter. Cheeses, § 170.3(n)(5) of this chapter ...... 8 Do. Gelatins, puddings, and fillings, § 170.3(n)(22) of this .75 Do. chapter. Jams and jellies, commercial, § 170.3(n)(28) of this .75 Do. chapter. All other food categories ...... 5 Do.

(d) [Reserved] of trees of various species of the genus (e) Prior sanctions for this ingredient Sterculia. different from the uses established in (b) The ingredient meets the speci- this regulation do not exist or have fications of the ‘‘Food Chemicals been waived. Codex,’’ 3d Ed. (1981), p. 157, which is incorporated by reference. Copies may be [42 FR 14653, Mar. 15, 1977, as amended at 42 obtained from the National Academy FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, Press, 2101 Constitution Ave. NW., 1984] Washington, DC 20418, or may be examined at the Office of the Federal Reg- § 184.1349 Karaya gum (sterculia gum). ister, 800 North Capitol Street, NW., (a) Karaya gum (sterculia gum) is the suite 700, Washington, DC 20408. dried gummy exudate from the trunk (c) The ingredient is used in food under the following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Frozen dairy desserts and mixes, § 170.3(n)(20) of 0.3 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and this chapter. thickener, § 170.3(o)(28) of this chapter.

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MAXIMUM USAGE LEVELS PERMITTED—Continued

Food (as served) Percent Function

Milk products, § 170.3(n)(31) of this chapter ...... 02 Stabilizer and thickener, § 170.3(o)(28) of this chapter. Soft candy, §170.3(n)(38) of this chapter ...... 9 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. All other food categories ...... 002 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter.

(d) [Reserved] that grows wild in mountainous re- (e) Prior sanctions for this ingredient gions of the Middle East. different from the uses established in (b) The ingredient meets the speci- this section do not exist or have been fications of the ‘‘Food Chemicals waived. Codex,’’ 3d Ed. (1981), p. 337, which is incorporated by reference. Copies may be [42 FR 14653, Mar. 15, 1977, as amended at 42 obtained from the National Academy FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, Press, 2101 Constitution Ave. NW., 1984] Washington, DC 20418, or may be examined at the Office of the Federal Reg- § 184.1351 Gum tragacanth. ister, 800 North Capitol Street, NW., (a) Gum tragacanth is the exudate suite 700, Washington, DC 20408. from one of several species of Astrag- (c) The ingredient is used in food alus gummifier Labillardiere, a shrub under the following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Baked goods and baking mixes, § 170.3(n)(1) of this 0.2 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; chapter. formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Condiments and relishes, § 170.3(n)(8) of this chap- .7 Do. ter. Fats and oils, § 170.3(n)(12) of this chapter ...... 1.3 Do. Gravies and sauces, § 170.3(n)(24) of this chapter .. .8 Do. Meat products, § 170.3(n)(29) of this chapter ...... 2 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Processed fruits and fruit juices, § 170.3(n)(35) of .2 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; this chapter. formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. All other food categories ...... 1 Do.

(d) [Reserved] the National Academy of Sciences. In (e) Prior sanctions for this ingredient the interim, the ingredient must be of different from the uses established in a purity suitable for its intended use. this section do not exist or have been (c) In accordance with § 184.1(b)(1), waived. the ingredient is used in food with no [42 FR 14653, Mar. 15, 1977, as amended at 42 limitations other than current good FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, manufacturing practice. The affirma- 1984] tion of this ingredient as generally recognized as safe (GRAS) as a direct § 184.1355 Helium. human food ingredient is based upon (a) Helium (empirical formula He, the following current good manufac- CAS Reg. No. 7440–59–7) is a colorless, turing practice conditions of use: odorless, flavorless, nonflammable, (1) The ingredient is used as a proc- inert gas. It is lighter than air and is essing aid as defined in § 170.3(o)(24) of produced by the liquefaction and purification of natural gas. this chapter. (b) The Food and Drug Administra- (2) The ingredient is used in food at tion is developing food-grade specifica- levels not to exceed current good man- tions for helium in cooperation with ufacturing practice.

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(d) Prior sanctions for this ingredient tion of barium peroxide with sulfuric different from the uses established in or phosphoric acid; by hydrogen reduc- this section do not exist or have been tion of 2-ethylanthraquinone, followed waived. by oxidation with air, to regenerate the quinone and produce hydrogen per- [48 FR 57270, Dec. 29, 1983] oxide; or by electrical discharge through a mixture of hydrogen, oxy- § 184.1366 Hydrogen peroxide. gen, and water vapor. (a) Hydrogen peroxide (H2O2, CAS (b) The ingredient meets the speci- Reg. No. 7722–84–1) is also referred to as fications of the Food Chemicals Codex, hydrogen dioxide. It is made by the 3d ed. (1981), pp. 146–147, 1 which is in- electrolytic oxidation of sulfuric acid corporated by reference. or a sulfate to persulfuric acid or a (c) In accordance with § 184.1(b)(2), persulfuric acid salt with subsequent the ingredient is used to treat food hydrolysis and distillation of the hy- only within the following specific limi- drogen peroxide formed; by decomposi- tations:

Maximum treatment Food level in food (percent) Functional use

Milk, intended for use during the cheesemaking 0.05 ...... Antimicrobial agent as defined in § 170.3 (o)(2) of process as permitted in the appropriate stand- this chapter ards of identity for cheese and related cheese products under part 133 of this chapter. Whey, during the preparation of modified whey by 0.04 ...... do. electrodialysis methods. Dried eggs, dried egg whites, and dried egg yolks Amount sufficient for Oxidizing and reducing agent as defined in § 170.3 as in §§ 160.105, 160.145, and 160.185 of this the purpose. (o)(22) of this chapter chapter. Tripe ...... do ...... Bleaching agent. Beef feet ...... Amount sufficient for Bleaching agent. the purpose. (Hy- drogen peroxide may be in the form of a compound salt, sodium carbonate peroxide). Herring ...... Amount sufficient for do. the purpose. Wine ...... do ...... Oxidizing and reducing agent as defined in § 170.3 (o)(22) of this chapter. Starch ...... 0.15 ...... Antimicrobial agent as defined in §170.3 (o)(2) of this chapter, to produce thermophile-free starch; Remove sulfur dioxide from starch slurry following steeping and grinding operations of corn refining. Instant tea ...... Amount sufficient for Bleaching agent. the purpose. Corn syrup ...... 0.15 ...... Reduce sulfur dioxide levels in the finished corn syrup. Colored (annatto) cheese whey ...... 0.05 ...... Bleaching agent. Wine vinegar ...... Amount sufficient for Remove sulfur dioxide from wine prior to fermenta- the purpose. tion to produce vinegar. Emulsifiers containing fatty acid esters ...... 1.25 ...... Bleaching agent.

(d) Residual hydrogen peroxide is re- this section do not exist or have been moved by appropriate physical and waived. chemical means during the processing [46 FR 44439, Sept. 4, 1981, as amended at 51 of food where it has been used accord- FR 27172, July 30, 1986] ing to paragraph (c) of this section. (e) Prior sanctions for this ingredient different from the uses established in

1 Copies may be obtained from the National the Office of the Federal Register, 800 North Academy of Sciences, 2101 Constitution Ave. Capitol Street, NW., suite 700, Washington, NW, Washington, DC 20037, or examined at DC 20408.

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§ 184.1370 Inositol. that produces no antibiotics. They are fixed (rendered insoluble) for batch (a) Inositol, or myo-inositol (C H O , 6 12 6 production with GRAS ingredients or CAS Reg. No. 87–89–8), is cis-1,2,3,5- may be fixed for further immobiliza- trans-4,6-cyclohexanehexol. It occurs tion with either GRAS ingredients or naturally and is prepared from an materials approved under § 173.357 of aqueous (0.2 percent sulfur dioxide) ex- this chapter. tract of corn kernels by precipitation (b) The ingredient meets the general and hydrolysis of crude phytate. and additional requirements for en- (b) The ingredient meets the speci- zyme preparations in the Food Chemi- fications of the Food Chemicals Codex, cals Codex, 3d Ed. (1981), p. 107, which is 3d Ed. (1981), p. 150, which is incor- incorporated by reference. Copies are porated by reference. Copies are avail- available from the National Academy able from the National Academy Press, Press, 2101 Constitution Ave. NW., 2101 Constitution Ave. NW., Wash- Washington, DC 20418, or available for ington, DC 20418, or available for in- inspection at the Office of the Federal spection at the Office of the Federal Register, 800 North Capitol Street, Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. NW., suite 700, Washington, DC 20408. (c) In accordance with § 184.1(b)(1), (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no the ingredient is used in food with no limitation other than current good limitations other than current good manufacturing practice. The affirma- manufacturing practice. The affirmation of this ingredient as generally rection of this ingredient as generally recognized as safe (GRAS) as a direct ognized as safe (GRAS) as a direct human food ingredient is based upon human food ingredient is based upon the following current good manufac- the following current good manufacturing practice conditions of use: turing practice conditions of use: (1) The ingredient is used as an en- (1) The ingredient is used as a nutri- zyme, as defined in § 170.3(o)(9) of this ent supplement as defined in chapter, to convert glucose to fructose. § 170.3(o)(20) of this chapter. (2) The ingredient is used in high (2) The ingredient is used in special fructose corn syrup, at levels not to ex- dietary foods as defined in part 105 of ceed current good manufacturing prac- this chapter at levels not to exceed tice. current good manufacturing practice. It may also be used in infant formula [48 FR 5720, Feb. 8, 1983, as amended at 61 FR 43450, Aug. 23, 1996] in accordance with section 412(g) of the Act, or with regulations promulgated § 184.1375 Iron, elemental. under section 412(a)(2) of the Act. (a) Iron, elemental (CAS Reg. No. (d) Prior sanctions for this ingredient 7439–89–6) is metallic iron obtained by different from the uses established by any of the following processes: reduced this section do not exist or have been iron, electrolytic iron, and carbonyl waived. iron. [47 FR 38278, Aug. 31, 1982] (1) Reduced iron is prepared by reacting ground ferric oxide with hydrogen § 184.1372 Insoluble glucose isomerase or carbon monoxide at an elevated enzyme preparations. temperature. The process results in a (a) Insoluble glucose isomerase en- grayish-black powder, all of which zyme preparations are used in the pro- should pass through a 100-mesh sieve. duction of high fructose corn syrup de- It is lusterless or has not more than a scribed in § 184.1866. They are derived slight luster. When viewed under a mi- from recognized species of precisely croscope, it appears as an amorphous classified nonpathogenic and powder free from particles having a nontoxicogenic microorganisms, in- crystalline structure. It is stable in dry cluding Streptomyces rubiginosus, air. Actinoplanes missouriensis, Streptomyces (2) Electrolytic iron is prepared by olivaceus, Streptomyces olivochromogenes, electrodeposition. It is an amorphous, and Bacillus coagulans, that have been lusterless, grayish-black powder. It is grown in a pure culture fermentation stable in dry air.

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(3) Carbonyl iron is prepared by the (1) The ingredient is used as an anti- decomposition of iron pentacarbonyl. oxidant as defined in § 170.3(o)(3) of this It occurs as a dark gray powder. When chapter; a sequestrant as defined in viewed under a microscope, it appears § 170.3(o)(26) of this chapter; and a sol- as spheres built up with concentric vent and vehicle as defined in shells. It is stable in dry air. § 170.3(o)(27) of this chapter. (b) Iron, elemental (carbonyl, elec- (2) The ingredient is used in mar- trolytic, or reduced) meets the speci- garine in accordance with § 166.110 of fications of the Food Chemicals Codex, this chapter; in nonalcoholic beverages 3d Ed. (1981) (iron, carbonyl, p. 151; as defined in § 170.3(n)(3) of this chap- iron, electrolytic, pp. 151–152; iron, re- ter; and in fats and oils as defined in duced; pp. 152–153), which is incor- § 170.3(n)(12) of this chapter at levels porated by reference. Copies are avail- not to exceed current good manufac- able from the National Academy Press, turing practice. 2101 Constitution Ave. NW., Wash- (d) Prior sanctions for this ingredient ington, DC 20418, or available for in- different from the uses established in spection at the Office of the Federal this section, or different from those set Register, 800 North Capitol Street, forth in part 181 of this chapter, do not NW., suite 700, Washington, DC 20408. exist or have been waived. (c) In accordance with § 184.1(b)(1), the ingredient is used in food as a nu- [59 FR 63896, Dec. 12, 1994] trient supplement as defined in § 170.3(o)(20) of this chapter, with no § 184.1387 Lactase enzyme preparation limitation other than current good from Candida pseudotropicalis. manufacturing practice. The ingre- (a) This enzyme preparation is de- dient may also be used in accordance rived from the nonpathogenic, with section 412(g) of the Federal Food, nontoxicogenic yeast C. Drug, and Cosmetic Act (the act) (21 pseudotropicalis. It contains the enzyme U.S.C. 350a(g)) or with regulations pro- lactase (b-D-galactoside mulgated under section 412(a)(2) of the galactohydrolase, EC 3.2.1.23), which act (21 U.S.C. 350a(2)). converts lactose to glucose and galac- (d) Prior sanctions for this ingredient tose. It is prepared from yeast that has different from the uses established in been grown by a pure culture fermenta- this section do not exist or have been tion process. waived. (b) The ingredient meets the general [53 FR 16867, May 12, 1988] requirements and additional requirements for enzyme preparations in the § 184.1386 Isopropyl citrate. Food Chemicals Codex, 3d ed. (1981), pp. (a) Isopropyl citrate is a mixture of 107–110, which are incorporated by ref- the mono-, di-, and triisopropyl esters erence in accordance with 5 U.S.C. of citric acid. It is prepared by 552(a) and 1 CFR part 51. Copies are esterifying citric acid with available from the National Academy isopropanol. Press, 2101 Constitution Ave. NW., (b) The Food and Drug Administra- Washington, DC 20418, or may be exam- tion, in cooperation with the National ined at the Center for Food Safety and Academy of Sciences, is developing Applied Nutrition’s Library, 5100 Paint food-grade specifications for isopropyl Branch Pkwy., College Park, MD 20740, citrate. In the interim, this ingredient or at the Office of the Federal Register, must be of a purity suitable for its in- 800 North Capitol St. NW., suite 700, tended use. Washington, DC. (c) In accordance with § 184.1(b)(1), (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no the ingredient is used in food with no limitation other than current good limitations other than current good manufacturing practice. The affirma- manufacturing practice. The affirmation of this ingredient as generally rection of this ingredient as generally recognized as safe (GRAS) as a direct ognized as safe as a direct human food human food ingredient is based upon ingredient is based upon the following the following current good manufac- current good manufacturing practice turing practice conditions of use: conditions of use:

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(1) The ingredient is used as an en- dient in milk to produce lactase-treat- zyme, as defined in § 170.3(o)(9) of this ed milk, which contains less lactose chapter, to convert lactose to glucose than regular milk, or lactose-reduced and galactose. milk, which contains at least 70 per- (2) The ingredient is used in food at cent less lactose than regular milk. levels not to exceed current good manufacturing practice. Current good man- [49 FR 47387, Dec. 4, 1984] ufacturing practice is limited to use of § 184.1400 Lecithin. this ingredient to reduce the lactose content in milk and milk-derived food (a) Commercial lecithin is a natu- products where food standards do not rally occurring mixture of the preclude such use. phosphatides of choline, ethanolamine, and inositol, with smaller amounts of [61 FR 7704, Feb. 29, 1996] othe lipids. It is isolated as a gum following hydration of solvent-extracted § 184.1388 Lactase enzyme preparation from Kluyveromyces lactis. soy, safflower, or corn oils. Lecithin is bleached, if desired, by hydrogen per- (a) This enzyme preparation is de- oxide and benzoyl peroxide and dried rived from the nonpathogenic, by heating. nontoxicogenic yeast Kluyveromyces (b) The ingredient meets the speci- lactis (previously named Saccharomyces fications of the Food Chemicals Codex, lactis). It contains the enzyme B- 3d Ed. (1981), pp. 166–167, which is incor- galactoside galactohydrase (CAS Reg. porated by reference. Copies are avail- No. CBS 683), which converts lactose to able from the National Academy Press, glucose and galactose. It is prepared 2101 Constitution Ave. NW., Wash- from yeast that has been grown in a ington, DC 20418, or available for in- pure culture fermentation and by using spection at the Office of the Federal materials that are generally recognized Register, 800 North Capitol Street, as safe or are food additives that have NW., suite 700, Washington, DC 20408. been approved for this use by the Food (c) In accordance with § 184.1(b)(1), and Drug Administration. the ingredient is used in food with no (b) The ingredient meets the general limitation other than current good and additional requirements for en- manufacturing practice. zyme preparations in the Food Chemi- (d) Prior sanctions for this ingredient cals Codex, 3d Ed. (1981), p. 107–110, different from the uses established in which is incorporated by reference. this section do not exist or have been Copies are available from the National waived. Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or avail- [48 FR 51150, Nov. 7, 1983] able for inspection at the Office of the Federal Register, 800 North Capitol § 184.1408 Licorice and licorice deriva- Street, NW., suite 700, Washington, DC tives. 20408. (a)(1) Licorice (glycyrrhiza) root is (c) In accordance with § 184.1(b)(1), the dried and ground rhizome and root the ingredient is used in food with no portions of Glycyrrhiza glabra or other limitation other than current good species of Glycyrrhiza. Licorice extract manufacturing practice. The affirma- is that portion of the licorice root that tion of this ingredient as generally rec- is, after maceration, extracted by boil- ognized as safe as a direct human food ing water. The extract can be further ingredient is based upon the following purified by filtration and by treatment current good manufacturing practice with acids and ethyl alcohol. Licorice conditions of use: extract is sold as a liquid, paste (1) The ingredient is used as an en- (‘‘block’’), or spray-dried powder. zyme as defined in §170.3(o)(9) of this (2) Ammoniated glycyrrhizin is pre- chapter to convert lactose to glucose pared from the water extract of lico- and galactose. rice root by acid precipitation followed (2) The ingredient is used in food at by neutralization with dilute ammonia. levels not to exceed current good man- Monoammonium glycyrrhizinate ufacturing practice. Current good man- (C42H61O16NH45H2O, CAS Reg. No. 1407– ufacturing practice is to use this ingre- 03–0) is prepared from ammoniated

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glycyrrhizin by solvent extraction and 3d Ed. (1981), p. 466, which is incor- separation techniques. porated by reference. Copies are avail- (b) The ingredients shall meet the able from the National Academy Press, following specifications when analyzed: 2101 Constitution Ave. NW., Wash- (1) Assay. The glycyrrhizin content of ington, DC 20418, or available for in- each flavoring ingredient shall be de- spection at the Office of the Federal termined by the method in the Official Register, 800 North Capitol Street, Methods of Analysis of the Association NW., suite 700, Washington, DC 20408. of Official Analytical Chemists, 13th (3) Acid unsoluble ash. Not more than Ed., §§ 19.136–19.140, which is incor- 2.5 percent for licorice on an anhydrous porated by reference, or by methods basis as determined by the method in 19.CO1 through 19.CO4 in the Journal of the Food Chemicals Codex, 3d Ed. the Association of Official Analytical (1981), p. 466, which is incorporated by Chemists, 65:471–472 (1982), which are reference. also incorporated by reference. Copies (4) Not more of all of these methods are available Heavy metals (as Pb). from the Association of Official Ana- than 40 parts per million as determined lytical Chemists, 2200 Wilson Blvd., by method II in the Food Chemicals Suite 400, Arlington, VA 22201–3301, or Codex, 3d Ed. (1981), p. 512, which is in- available for inspection at the Office of corporated by reference. the Federal Register, 800 North Capitol (5) Arsenic (As). Not more than 3 parts Street, NW., suite 700, Washington, DC per million as determined by the meth- 20408. od in the Food Chemicals Codex. 3d Ed. (2) Ash. Not more than 9.5 percent for (1981), p. 464, which is incorporated by licorice, 2.5 percent for ammoniated reference. glycyrrhizin, and 0.5 percent for (c) In accordance with § 184.1(b)(2), monoammonium glycyrrhizinate on an these ingredients are used in food only anhydrous basis as determined by the within the following specific limita- method in the Food Chemicals Codex, tions:

Maximum level in food (percent Category of food glycyrrhizin con- Functional use tent of food) (as served)

Baked foods, §170.3(n)(1) of this chapter ...... 0 .05 Flavor enhancer, §170.3(o)(11) of this chapter; flavoring agent, §170.3(o)(12) of this chapter. Alcoholic beverages, §170.3(n)(2) of this chapter ..... 0 .1 Flavor enhancer, §170.3(o)(11) of this chapter; flavoring agent, §170.3(o)(12) of this chapter; surface-active agent, §170.3(o)(29) of this chapter. Nonalcoholic beverages, §170.3(n)(3) of this chapter 0 .15 Do. Chewing gum, §170.3(n)(6) of this chapter ...... 1.1 Flavor enhancer, §170.3(o)(11) of this chapter; flavoring agent, §170.3(n)(12) of this chapter. Hard candy, §170.3(n)(25) of this chapter ...... 16 .0 Do. Herbs and seasonings, §170.3(n)(26) of this chapter 0 .15 Do. Plant protein products, §170.3(n)(33) of this chapter 0.15 Do. Soft candy, §170.3(n)(38) of this chapter ...... 3 .1 Do. Vitamin or mineral dietary supplements ...... 0 .5 Do. All other foods except sugar substitutes, 0 .1 Do. §170.3(n)(42) of this chapter. The ingredient is not permitted to be used as a nonnutritive sweetener in sugar substitutes.

(d) Prior sanctions for this ingredient § 184.1409 Ground limestone. different from the uses established in (a) Ground limestone consists essen- this section do not exist or have been tially (not less than 94 percent) of cal- waived. cium carbonate (CaCO3) and is prepared [50 FR 21044, May 22, 1985, as amended at 54 by the crushing, grinding, and FR 24899, June 12, 1989] classifying of naturally occurring limestone. (b) The ingredient meets the specifications of the Food Chemicals Codex,

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3d Ed. (1981), p. 173, which is incor- (2) The ingredient is used in food at porated by reference. Copies are avail- levels not to exceed current good man- able from the National Academy Press, ufacturing practice. 2101 Constitution Ave. NW., Wash- [60 FR 32911, June 26, 1995] ington, DC 20418, or available for inspection at the Office of the Federal § 184.1420 Lipase enzyme preparation Register, 800 North Capitol Street, derived from Rhizopus niveus. NW., suite 700, Washington, DC 20408. (a) Lipase enzyme preparation con- (c) In accordance with § 184.1(b)(1), tains lipase enzyme (CAS Reg. No. the ingredient is used in food with no 9001–62–1), which is obtained from the limitation other than current good culture filtrate resulting from a pure manufacturing practice. culture fermentation of a nonpatho- (d) Prior sanctions for this ingredient genic and nontoxigenic strain of different from the uses established in Rhizopus niveus. The enzyme prepara- this section do not exist or have been tion also contains diatomaceous earth waived. as a carrier. The characterizing activity of the enzyme, which catalyzes the [48 FR 52442, Nov. 18, 1983] interesterification of fats and oils at the 1- and 3-positions of triglycerides, § 184.1415 Animal lipase. is triacylglycerol lipase (EC 3.1.1.3). (a) Animal lipase (CAS Reg. No. 9001– (b) The ingredient meets the general 62–1) is an enzyme preparation obtained requirements and additional require- from edible forestomach tissue of ments for enzyme preparations in the calves, kids, or lambs, or from animal monograph on Enzyme Preparations in pancreatic tissue. The enzyme prepara- the ‘‘Food Chemicals Codex,’’ 4th ed. tion may be produced as a tissue prepa- (1996), pp. 133 and 134, which is incor- ration or as an aqueous extract. Its porated by reference in accordance characterizing enzyme activity is that with 5 U.S.C. 552(a) and 1 CFR part 51. of a triacylglycerol hydrolase (EC Copies are available from the National 3.1.1.3). Academy Press, 2101 Constitution Ave. (b) The ingredient meets the general NW., Washington, DC 20418, or may be requirements and additional require- examined at the Center for Food Safety ments for enzyme preparations in the and Applied Nutrition’s Library, 5100 Food Chemicals Codex, 3d ed. (1981), p. Paint Branch Pkwy., College Park, MD 110, which is incorporated by reference 20740, or the Office of the Federal Reg- in accordance with 5 U.S.C. 552(a) and 1 ister, 800 North Capitol St. NW., suite CFR part 51. Copies are available from 700, Washington, DC. the National Academy Press, 2101 Con- (c) In accordance with § 184.1(b)(1), stitution Ave., NW., Washington, DC the ingredient is used in food with no 20418, or may be examined at the Office limitation other than current good of Premarket Approval (HFS–200), Food manufacturing practice. The affirma- and Drug Administration, 5100 Paint tion of this ingredient as generally rec- Branch Pkwy., College Park, MD 20740, ognized as safe as a direct human food and the Office of the Federal Register, ingredient is based upon the following 800 North Capitol St., NW., suite 700, current good manufacturing practice Washington, DC. conditions of use: (c) In accordance with § 184.1(b)(1), (1) The ingredient is used as an en- the ingredient is used in food with no zyme as defined in § 170.3(o)(9) of this limitation other than current good chapter for the interesterification of manufacturing practice. The affirma- fats and oils. tion of this ingredient as GRAS as a di- (2) The ingredient is used in food at rect food ingredient is based upon the levels not to exceed current good man- following current good manufacturing ufacturing practice. practice conditions of use: [63 FR 24419, May 4, 1998] (1) The ingredient is used as an enzyme as defined in § 170.3(o)(9) of this § 184.1425 Magnesium carbonate. chapter to hydrolyze fatty acid (a) Magnesium carbonate (molecular glycerides. formula approximately

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(MgCO3)4·Mg(OH)2·5H2O, CAS Reg. No. lution and crystallizing out magnesium 39409–82–0) is also known as magnesium chloride hexahydrate. carbonate hydroxide. It is a white pow- (b) The ingredient meets the speci- der formed either by adding an alkaline fications of the Food Chemicals Codex, carbonate (such as sodium carbonate) 3d Ed. (1981), p. 177, which is incor- to a solution of magnesium sulfate or porated by reference. Copies are avail- by carbonation of a slurry of magne- able from the National Academy Press, sium hydroxide followed by boiling of 2101 Constitution Ave. NW., Wash- the resulting magnesium carbonate. ington, DC 20418, or available for in- (b) The ingredient meets the speci- spection at the Office of the Federal fications of the Food Chemicals Codex, Register, 800 North Capitol Street, 3d Ed. (1981), p. 177, which is incor- NW., suite 700, Washington, DC 20408. porated by reference. Copies are avail- (c) In accordance with § 184.1(b)(1), able from the National Academy Press, the ingredient is used in food with no 2101 Constitution Ave. NW., Wash- limitation other than current good ington, DC 20418, or available for in- manufacturing practice. The affirma- spection at the Office of the Federal tion of this ingredient as generally rec- Register, 800 North Capitol Street, ognized as safe (GRAS) as a direct NW., suite 700, Washington, DC 20408. human food ingredient is based upon (c) In accordance with § 184.1(b)(1), the following current good manufac- the ingredient is used in food with no turing practice conditions of use: limitation other than current good (1) The ingredient is used as a fla- manufacturing practice. The affirma- voring agent and adjuvant as defined in tion of this ingredient as generally rec- § 170.3(o)(12) of this chapter and a nutri- ognized as safe (GRAS) as a direct ent supplement as defined in human food ingredient is based upon § 170.3(o)(20) of this chapter. the following current good manufacturing practice conditions of use: (2) The ingredient is used in foods at (1) The ingredient is used as an levels not to exceed current good man- anticaking and free-flow agent as de- ufacturing practice. The ingredient fined in § 170.3(o)(1) of this chapter; a also may be used in infant formula in flour treating agent as defined in accordance with section 412(g) of the § 170.3(o)(13) of this chapter; a lubricant Federal Food, Drug, and Cosmetic Act and release agent as defined in (the act) or with regulations promul- § 170.3(o)(18) of this chapter; a nutrient gated under section 412(a)(2) of the act. supplement as defined in § 170.3(o)(20) of (d) Prior sanctions for this ingredient this chapter; a pH control agent as de- different from the uses established in fined in § 170.3(o)(23) of this chapter; a this section do not exist or have been processing aid as defined in § 170.3(o)(24) waived. of this chapter; and a synergist as de- [50 FR 13559, Apr. 5, 1985; 50 FR 16080, Apr. 24, fined in § 170.3(o)(31) of this chapter. 1985] (2) The ingredient is used in foods at levels not to exceed current good man- § 184.1428 Magnesium hydroxide. ufacturing practice. (a) Magnesium hydroxide (Mg(OH)2, (d) Prior sanctions for this ingredient CAS Reg. No. 1309–42–8) occurs natu- different from the uses established in rally as the colorless, crystalline min- this section do not exist or have been eral brucite. It is prepared as a white waived. precipitate by the addition of sodium [50 FR 13558, Apr. 5, 1985; 50 FR 16080, Apr. 24, hydroxide to a water soluble magne- 1985] sium salt or by hydration of reactive grades of magnesium oxide. § 184.1426 Magnesium chloride. (b) The ingredient meets the speci- (a) Magnesium chloride (MgC12·6H2O, fications of the Food Chemicals Codex, CAS Reg. No. 7786–30–3) is a colorless, 3d Ed. (1981), p. 178, which is incor- deliquescent, crystalline material that porated by reference. Copies are avail- occurs naturally as the mineral able from the National Academy Press, bischofite. It is prepared by dissolving 2101 Constitution Ave. NW., Wash- magnesium oxide, hydroxide, or car- ington, DC 20418, or available for in- bonate in aqueous hydrochloric acid so- spection at the Office of the Federal

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Register, 800 North Capitol Street, tion of this ingredient as generally rec- NW., suite 700, Washington, DC 20408. ognized as safe (GRAS) as a direct (c) In accordance with § 184.1(b)(1), human food ingredient is based upon the ingredient is used in food with no the following current good manufac- limitation other than current good turing practice conditions of use: manufacturing practice. The affirma- (1) The ingredient is used as an tion of this ingredient as generally rec- anticaking and free-flow agent as de- ognized as safe (GRAS) as a direct fined in § 170.3(o)(1) of this chapter; a human food ingredient is based upon firming agent as defined in § 170.3(o)(10) the following current good manufac- of this chapter; a lubricant and release turing practice conditions of use: agent as defined in § 170.3(o)(18) of this (1) The ingredient is used as a nutri- chapter; a nutrient supplement as de- ent supplement as defined in fined in § 170.3(o)(20) of this chapter; § 170.3(o)(20) of this chapter; a pH con- and a pH control agent as defined in trol agent as defined in § 170.3(o)(23) of § 170.3(o)(23) of this chapter. this chapter; and a processing aid as (2) The ingredient is used in foods at defined in § 170.3(o)(24) of this chapter. levels not be exceed current good man- (2) The ingredient is used in foods at ufacturing practice. The ingredient levels not to exceed current good man- also may be used in infant formula in ufacturing practice. accordance with section 412(g) of the (d) Prior sanctions for this ingredient Federal Food, Drug, and Cosmetic Act different from the uses established in (the act) or with regulations promul- this section do not exist or have been gated under section 412(a)(2) of the act. waived. (d) Prior sanctions for this ingredient different from the uses established in [50 FR 13559, Apr. 5, 1985, as amended at 64 FR 405, Jan. 5, 1999] this section do not exist or have been waived. § 184.1431 Magnesium oxide. [50 FR 13559, Apr. 5, 1985] (a) Magnesium oxide (MgO, CAS Reg. No. 1309–48–4) occurs naturally as the § 184.1434 Magnesium phosphate. colorless, crystalline mineral periclase. (a) Magnesium phosphate includes It is produced either as a bulky white both magnesium phosphate, dibasic, powder (light) or a relatively dense and magnesium phosphate, tribasic. white powder (heavy) by heating mag- Magnesium phosphate, dibasic nesium hydroxide or carbonate. Heat- (MgHPO4·3H2O, CAS Reg. No. 7782–0975– ing these magnesium salts under mod- 094) occurs naturally as the white, erate conditions (400° to 900 °C for a few crystalline mineral newberyite. It is hours) produces light magnesium prepared commercially as a precipitate oxide. Heating the salts under more formed by treating a solution of mag- rigorous conditions (1200 °C for 12 nesium sulfate with disodium phos- hours) produces heavy magnesium phate under controlled conditions. oxide. Light magnesium oxide is con- Magnesium phosphate, tribasic verted to heavy magnesium oxide by (Mg3(PO4)2·xH2O, CAS Reg. No. 7727– sustained heating at high tempera- 0987–091) may contain 4, 5, or 8 mol- tures. ecules of water of hydration. It is pro- (b) The ingredient meets the speci- duced as a precipitate from a solution fications of the Food Chemicals Codex, of magnesite with phosphoric acid. 3d Ed. (1981), p. 178, which is incor- (b) Magnesium phosphate, dibasic, porated by reference. Copies are avail- meets the specifications of the Food able from the National Academy Press, Chemicals Codex, 3d Ed. (1981), p. 179, 2101 Constitution Ave. NW., Wash- which is incorporated by reference. ington, DC 20418, or available for in- Magnesium phosphate, tribasic, meets spection at the Office of the Federal the specifications of the Food Chemi- Register, 800 North Capitol Street, cals Codex, 3d Ed. (1981), p. 180, which is NW., suite 700, Washington, DC 20408. incorporated by reference. Copies are (c) In accordance with § 184.1(b)(1), available from the National Academy the ingredient is used in food with no Press, 2101 Constitution Ave. NW., limitation other than current good Washington, DC 20418, or available for manufacturing practice. The affirma- inspection at the Office of the Federal

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Register, 800 North Capitol Street, the following current good manufac- NW., suite 700, Washington, DC 20408. turing practice conditions of use: (c) In accordance with § 184.1(b)(1), (1) The ingredient is used as a lubri- the ingredient is used in food with no cant and release agent as defined in limitation other than current good § 170.3(o)(18) of this chapter; a nutrient manufacturing practice. The affirma- supplement as defined in § 170.3(o)(20) of tion of this ingredient as generally rec- this chapter; and a processing aid as ognized as safe (GRAS) as a direct defined in § 170.3(o)(24) of this chapter. human food ingredient is based upon (2) The ingredient is used in foods at the following current good manufac- levels not to exceed current good man- turing practice conditions of use: ufacturing practice. (1) The ingredient is used as a nutri- (d) Prior sanctions for this ingredient ent supplement as defined in different from the uses established in § 170.3(o)(20) of this chapter and a pH this section do not exist or have been control agent as defined in § 170.3(o)(23) waived. of this chapter. (2) The ingredient is used in foods at [50 FR 13560, Apr. 5, 1985] levels not to exceed current good man- § 184.1443 Magnesium sulfate. ufacturing practice. The ingredient also may be used in infant formula in (a) Magnesium sulfate (MgSO4·7H2O, accordance with section 412(g) of the CAS Reg. No. 10034–99–8) occurs natu- Federal Food, Drug, and Cosmetic Act rally as the mineral epsomite. It is pre- (the act) or with regulations promul- pared by neutralization of magnesium gated under section 412(a)(2) of the Act. oxide, hydroxide, or carbonate with (d) Prior sanctions for this ingredient sulfuric acid and evaporating the solu- different from the uses established in tion to crystallization. this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the Food Chemicals Codex, 3d Ed. (1981), p. 183, which is incor- [50 FR 13560, Apr. 5, 1985] porated by reference. Copies are avail- § 184.1440 Magnesium stearate. able from the National Academy Press, 2101 Constitution Ave. NW., Wash- (a) Magnesium stearate ington, DC 20418, or available for in- (Mg(C17H34COO)2, CAS Reg. No. 557–04– spection at the Office of the Federal 0) is the magnesium salt of stearic Register, 800 North Capitol Street, acid. It is produced as a white precipi- NW., suite 700, Washington, DC 20408. tate by the addition of an aqueous so- (c) In accordance with § 184.1(b)(1), lution of magnesium chloride to an the ingredient is used in food with no aqueous solution of sodium stearate de- limitation other than current good rived from stearic acid that is obtained manufacturing practice. The affirma- from edible sources and that conforms tion of this ingredient as generally rec- to the requirements of § 172.860(b)(2) of ognized as safe (GRAS) as a direct this chapter. human food ingredient is based upon (b) The ingredient meets the speci- the following current good manufac- fications of the Food Chemicals Codex, turing practice conditions of use: 3d Ed. (1981), p. 182, which is incor- (1) The ingredient is used as a flavor porated by reference. Copies are avail- enhancer as defined in § 170.3(o)(11) of able from the National Academy Press, this chapter; a nutrient supplement as 2101 Constitution Ave. NW., Wash- defined in § 170.3(o)(20) of this chapter; ington, DC 20418, or available for in- and a processing aid as defined in spection at the Office of the Federal § 170.3(o)(24) of this chapter. Register, 800 North Capitol Street, (2) The ingredient is used in foods at NW., suite 700, Washington, DC 20408. (c) In accordance with § 184.1(b)(1), levels not to exceed current good man- the ingredient is used in food with no ufacturing practice. limitation other than current good (d) Prior sanctions for this ingredient manufacturing practice. The affirma- different from the uses established in tion of this ingredient as generally rec- this section do not exist or have been ognized as safe (GRAS) as a direct waived. human food ingredient is based upon [50 FR 13560, Apr. 5, 1985]

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§ 184.1443a Malt. (2) Maltodextrin derived from potato (a) Malt is an enzyme preparation ob- starch meets the specifications of the tained from barley which has been soft- Food Chemicals Codex, 3d ed., 3d supp. ened by a series of steeping operations (1992), p. 125, which are incorporated by and germinated under controlled condi- reference in accordance with 5 U.S.C. tions. It is a brown, sweet, and viscous 552(a) and 1 CFR part 51. Copies are liquid or a white to tan powder. Its available from the National Academy characterizing enzyme activities are a- Press, 2101 Constitution Ave., NW., amylase (EC 3.2.1.1.) and b-amylase (EC Washington, DC 20418, or may be exam- 3.2.1.2). ined at the Office of the Federal Reg- (b) The ingredient meets the general ister, 800 North Capital St. NW., suite requirements and additional require- 700, Washington, DC 20408, or at the Di- ments for enzyme preparations in the vision of Petition Control (HFS–217), Food Chemicals Codex, 3d ed. (1981), p. Center for Food Safety and Applied Nu- 110, which is incorporated by reference trition, Food and Drug Administration, in accordance with 5 U.S.C. 552(a) and 1 5100 Paint Branch Pkwy., College Park, CFR part 51. Copies are available from MD 20740. the National Academy Press, 2101 Con- (3) Maltodextrin derived from rice stitution Ave., NW., Washington, DC starch meets the specifications of the 20418, or may be examined at the Office Food Chemicals Codex, 4th ed. (1996), of Premarket Approval (HFS–200), Food pp. 239 and 240, which is incorporated and Drug Administration, 5100 Paint by reference in accordance with 5 Branch Pkwy., College Park, MD 20740, U.S.C. 552(a) and 1 CFR part 51. Copies and the Office of the Federal Register, are available from the National Acad- 800 North Capitol St., NW., suite 700, emy Press, 2101 Constitution Ave. NW., Washington, DC. Washington, DC 20418, or may be exam- (c) In accordance with § 184.1(b)(1), ined at the Center for Food Safety and the ingredient is used in food with no Applied Nutrition’s Library, 5100 Paint limitation other than current good Branch Pkwy., College Park, MD 20740, manufacturing practice. The affirma- or at the Office of the Federal Register, tion of this ingredient as GRAS as a di- 800 North Capitol St. NW., suite 700, rect food ingredient is based upon the Washington, DC. following current good manufacturing (c) In accordance with § 184.1(b)(1), practice conditions of use: the ingredient is used in food with no (1) The ingredient is used as an en- limitation other than current good zyme as defined in § 170.3(o)(9) of this manufacturing practice. chapter to hydrolyze starch or starch- (d) Prior sanctions for this ingredient derived polysaccharides. different from the uses established in (2) The ingredient is used in food at this section do not exist or have been levels not to exceed current good man- waived. ufacturing practice. [48 FR 51911, Nov. 15, 1983; as amended at 60 [60 FR 32911, June 26, 1995] FR 48893, Sept. 21, 1995; 63 FR 14611, Mar. 26, 1998] § 184.1444 Maltodextrin. § 184.1445 Malt syrup (malt extract). (a) Maltodextrin ((C6H10O5)n, CAS Reg. No. 9050–36–6) is a nonsweet nutri- (a) Malt is the product of barley tive saccharide polymer that consists (Hordeum vulgare L.) germinated under of D-glucose units linked primarily by controlled conditions. Malt syrup and a-1-4 bonds and that has a dextrose malt extract are interchangeable terms equivalent (D.E.) of less than 20. It is for a viscous concentrate of water ex- prepared as a white powder or contract of germinated barley grain, with centrated solution by partial hydrol- or without added safe preservative. ysis of corn starch, potato starch, or Malt syrup is usually a brown, sweet, rice starch with safe and suitable acids and viscous liquid containing varying and enzymes. amounts of amylolytic enzymes and (b)(1) Maltodextrin derived from corn plant constituents. Barley is first soft- starch must be of a purity suitable for ened after cleaning by steeping oper- its intended use. ations and then allowed to germinate

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under controlled conditions. The ger- tion of this ingredient as generally rec- minated grain then undergoes proc- ognized as safe (GRAS) as a direct essing, such as drying, grinding, ex- human food ingredient is based upon tracting, filtering, and evaporating, to the following current good manufac- produce malt syrup (malt extract) with turing practice conditions of use: 75 to 80 percent solids or dried malt (1) The ingredient is used as a nutri- syrup with higher solids content. ent supplement as defined in (b) FDA is developing food-grade § 170.3(o)(20) of this chapter. specifications for malt syrup (malt ex- (2) The ingredient may be used in in- tract) in cooperation with the National fant formulas in accordance with sec- Academy of Sciences. In the interim, tion 412(g) of the Federal Food, Drug, the ingredient must be of a purity suit- and Cosmetic Act (the act) or with reg- able for its intended use. ulations promulgated under section (c) In accordance with § 184.1(b)(1), 412(a)(2) of the act. the ingredient is used in food with no (d) Prior sanctions for this ingredient limitation other than current good different from the uses established in manufacturing practice. The affirma- this section do not exist or have been tion of this ingredient as generally rec- waived. ognized as safe (GRAS) as a direct [50 FR 19165, May 7, 1985] human food ingredient is based upon the following current good manufac- § 184.1449 Manganese citrate. turing practice conditions of use: (a) Manganese citrate (Mn (C H O ) , (1) The ingredient is used as a fla- 3 6 5 7 2 CAS Reg. No. 1002–46–65) is a pale or- voring agent and adjuvant as defined in ange or pinkish white powder. It is ob- § 170.3(o)(12) of this chapter. tained by precipitating manganese car- (2) The ingredient is used in food at bonate from manganese sulfate and so- levels not to exceed current good man- dium carbonate solutions. The filtered ufacturing practice. (d) Prior sanctions for this ingredient and washed precipitate is digested first different from the uses established in with sufficient citric acid solution to this section do not exist or have been form manganous citrate and then with waived. sodium citrate to complete the reaction. [48 FR 51613, Nov. 10, 1983] (b) FDA is developing food-grade specifications for manganese citrate in § 184.1446 Manganese chloride. cooperation with the National Acad- (a) Manganese chloride (MnCl2·4H2O, emy of Sciences. In the interim, this CAS Reg. No. 7773–01–5) is a pink, ingredient must be of purity suitable translucent, crystalline product. It is for its intended use. also known as manganese dichloride. It (c) In accordance with § 184.1(b)(1), is prepared by dissolving manganous the ingredient is used in food with no oxide, pyrolusite ore (MnO2), or re- limitation other than current good duced manganese ore in hydrochloric manufacturing practice. The affirma- acid. The resulting solution is neutral- tion of this ingredient as generally rec- ized to precipitate heavy metals, fil- ognized as safe (GRAS) as a direct tered, concentrated, and crystallized. human food ingredient is based upon (b) The ingredient meets the speci- the following current good manufac- fications of the Food Chemicals Codex, turing practice conditions of use: 3d Ed. (1981), p. 186, which is incor- (1) The ingredient is used as a nutri- porated by reference. Copies are avail- ent supplement as defined in able from the National Academy Press, § 170.3(o)(20) of this chapter. 2101 Constitution Ave. NW., Wash- (2) The ingredient is used in the fol- ington, DC 20418, or available for in- lowing foods at levels not to exceed spection at the Office of the Federal current good manufacturing practice: Register, 800 North Capitol Street, baked goods as defined in § 170.3(n)(1) of NW., suite 700, Washington, DC 20408. this chapter; nonalcoholic beverages as (c) In accordance with § 184.1(b)(1), defined in § 170.3(n)(3) of this chapter; the ingredient is used in food with no dairy product analogs as defined in limitation other than current good § 170.3(n)(10) of this chapter; fish prod- manufacturing practice. The affirma- ucts as defined in § 170.3(n)(13) of this

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chapter; meat products as defined in chapter; and poultry products as de- § 170.3(n)(29) of this chapter; milk prod- fined in § 170.3(n)(34) of this chapter. ucts as defined in § 170.3(n)(31) of this The ingredient may be used in infant chapter; and poultry products as de- formulas in accordance with section fined in § 170.3(n)(34) of this chapter. 412(g) of the Federal Food, Drug, and The ingredient may be used in infant Cosmetic Act (the act) or with regula- formulas in accordance with section tions promulgated under section 412(g) of the Federal Food, Drug, and 412(a)(2) of the act. Cosmetic Act (the act) or with regula- (d) Prior sanctions for this ingredient tions promulgated under section different from the uses established in 412(a)(2) of the act. this section do not exist or have been (d) Prior sanctions for this ingredient waived. different from the uses established in [50 FR 19166, May 7, 1985] this section do not exist or have been waived. § 184.1461 Manganese sulfate.

[50 FR 19166, May 7, 1985] (a) Manganese sulfate (MnSO4·H2O, CAS Reg. No. 7785–0987–097) is a pale § 184.1452 Manganese gluconate. pink, granular, odorless powder. It is (a) Manganese gluconate obtained by reacting manganese com- (C12H22MnO14·2H2O, CAS Reg. No. 648– pounds with sulfuric acid. It is also ob- 0953–0998) is a slightly pink colored tained as a byproduct in the manufac- powder. It is obtained by reacting man- ture of hydroquinone. Other manufac- ganese carbonate with gluconic acid in turing processes include the action of aqueous medium and then crystallizing sulfur dioxide on a slurry of manganese the product. dioxide in sulfuric acid, and the roast- (b) The ingredient meets the speci- ing of pyrolusite (MnO2) ore with solid fications of the Food Chemicals Codex, ferrous sulfate and coal, followed by 3d Ed. (1981), p. 186, which is incor- leaching and crystallization. porated by reference. Copies are avail- (b) The ingredient meets the speci- able from the National Academy Press, fications of the Food Chemicals Codex, 2101 Constitution Ave. NW., Wash- 3d Ed. (1981), p. 188, which is incor- ington, DC 20418, or available for in- porated by reference. Copies are avail- spection at the Office of the Federal able from the National Academy Press, Register, 800 North Capitol Street, 2101 Constitution Ave. NW., Wash- NW., suite 700, Washington, DC 20408. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(1), spection at the Office of the Federal the ingredient is used in food with no Register, 800 North Capitol Street, limitation other than current good NW., suite 700, Washington, DC 20408. manufacturing practice. The affirma- (c) In accordance with § 184.1(b)(1), tion of this ingredient as generally rec- the ingredient is used in food with no ognized as safe (GRAS) as a direct limitation other than current good human food ingredient is based upon manufacturing practice. The affirma- the following current good manufac- tion of this ingredient as generally rec- turing practice conditions of use: ognized as safe (GRAS) as a direct (1) The ingredient is used as a nutri- human food ingredient is based upon ent supplement as defined in the following current good manufac- § 170.3(o)(20) of this chapter. turing practice conditions of use: (2) The ingredient is used in the fol- (1) The ingredient is used as a nutri- lowing foods at levels not to exceed ent supplement as defined in current good manufacturing practice: § 170.3(o)(20) of this chapter. baked goods as defined in § 170.3(n)(1) of (2) The ingredient is used in the fol- this chapter; nonalcoholic beverages as lowing foods at levels not to exceed defined in § 170.3(n)(3) of this chapter; current good manufacturing practice: dairy product analogs as defined in baked goods as defined in § 170.3(n)(1) of § 170.3(n)(10) of this chapter; fish prod- this chapter; nonalcoholic beverages as ucts as defined in § 170.3(n)(13) of this defined in § 170.3(n)(3) of this chapter; chapter; meat products as defined in dairy product analogs as defined in § 170.3(n)(29) of this chapter; milk prod- § 170.3(n)(10) of this chapter; fish products as defined in § 170.3(n)(31) of this ucts as defined in § 170.3(n(13) of this

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chapter; meat products as defined in Method,’’ which is incorporated by ref- § 170.3(n)(29) of this chapter; milk prod- erence in accordance with 5 U.S.C. ucts as defined in § 170.3(n)(31) of this 552(a) and 1 CFR part 51. The avail- chapter; and poultry products as de- ability of this incorporation by ref- fined in § 170.3(n)(34) of this chapter. erence is given in paragraph (a)(2)(iii) The ingredient may be used in infant of this section. formulas in accordance with section (v) Unsaponifiable matter. Not more 412(g) of the Federal Food, Drug, and than 1.5 percent as determined by the Cosmetic Act (the act) or with regula- American Oil Chemists’ Society Offi- tions promulgated under section cial Method Ca 6b–53—‘‘Unsaponifiable 412(a)(2) of the act. Matter’’ (reapproved 1989), which is in- (d) Prior sanctions for this ingredient corporated by reference in accordance different from the uses established in with 5 U.S.C. 552(a) and 1 CFR part 51. this section do not exist or have been The availability of this incorporation waived. by reference is given in paragraph (a)(2)(iii) of this section. [50 FR 19166, May 7, 1985] (vi) Free fatty acids. Not more than 0.1 percent as determined by the American § 184.1472 Menhaden oil. Oil Chemists’ Society Official Method (a) Menhaden oil. (1) Menhaden oil is Ca 5a–40—‘‘Free Fatty Acids’’ (re- prepared from fish of the genus approved 1989), which is incorporated Brevoortia, commonly known as menha- by reference in accordance with 5 den, by cooking and pressing. The re- U.S.C. 552(a) and 1 CFR part 51. The sulting crude oil is then refined using availability of this incorporation by the following steps: Storage (winteriza- reference is given in paragraph tion), degumming (optional), neutral- (a)(2)(iii) of this section. ization, bleaching, and deodorization. (vii) Peroxide value. Not more than 5 Winterization may separate the oil and milliequivalents per kilogram of oil as produce a solid fraction. determined by the American Oil Chem- (2) Menhaden oil meets the following ists’ Society Official Method Cd 8–53— specifications: ‘‘Peroxide Value, Acetic Acid—Chloro- (i) Color and state. Yellow liquid to form Method’’ (updated 1992) or Rec- white solid. ommended Practice Cd 8b–90—‘‘Per- (ii) Odor. Odorless to slightly fishy. oxide Value, Acetic Acid—Isooctane (iii) Saponification value. Between 180 Method’’ (updated 1992), which are in- and 200 as determined by the American corporated by reference in accordance Oil Chemists’ Society Official Method with 5 U.S.C. 552(a) and 1 CFR part 51. Cd 3–25—‘‘Saponification Value’’ (re- The availability of this incorporation approved 1989), which is incorporated by reference is given in paragraph by reference in accordance with 5 (a)(2)(iii) of this section. U.S.C. 552(a) and 1 CFR part 51. Copies (viii) Lead. Not more than 0.1 part of this publication are available from per million as determined by the Amer- the Office of Premarket Approval, Cen- ican Oil Chemists’ Society Official ter for Food Safety and Applied Nutri- Method Ca 18c–91—‘‘Determination of tion (HFS–200), Food and Drug Admin- Lead by Direct Graphite Furnace istration, 5100 Paint Branch Pkwy., Atomic Absorption Spectrometry’’ (re- College Park, MD 20740, or available for vised 1992), which is incorporated by inspection at the Center for Food Safe- reference in accordance with 5 U.S.C. ty and Applied Nutrition’s Library, 552(a) and 1 CFR part 51. The avail- Food and Drug Administration, 5100 ability of this incorporation by ref- Paint Branch Pkwy., College Park, MD erence is given in paragraph (a)(2)(iii) 20740, or at the Office of the Federal of this section. Register, 800 North Capitol St. NW., (ix) Mercury. Not more than 0.5 part suite 700, Washington, DC. per million as determined by the meth- (iv) Iodine number. Not less than 120 od entitled ‘‘Biomedical Test Materials as determined by the American Oil Program: Analytical Methods for the Chemists’ Society Recommended Prac- Quality Assurance of Fish Oil,’’ pub- tice Cd 1d–92—‘‘Iodine Value of Fats lished in the ‘‘NOAA Technical Memo- and Oils, Cyclohexane—Acetic Acid randum NMFS–SEFC–211,’’ F. M. Van

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Dolah and S. B. Galloway, editors, Na- (iii) Saponification value. Between 180 tional Marine Fisheries Service, U. S. and 200. Department of Commerce, pages 71–88, (iv) Iodine number. Not more than 119 November, 1988, which is incorporated for partially hydrogenated menhaden by reference in accordance with 5 oil and not more than 10 for fully hy- U.S.C. 552(a) and 1 CFR part 51. The drogenated menhaden oil. availability of this incorporation by (v) Unsaponifiable matter. Not more reference is given in paragraph than 1.5 percent.– (a)(2)(iii) of this section. (vi) Free fatty acids. Not more than 0.1 (3) In accordance with § 184.1(b)(2), percent. the ingredient may be used in food only (vii) Peroxide value. Not more than 5 within the following specific limita- milliequivalents per kilogram of oil. tions: (viii) Nickel. Not more than 0.5 part Category of food Maximum level of use per million. in food (as served) (ix) Mercury. Not more than 0.5 part Cookies, crackers, § 170.3(n)(1) of 5.0 percent per million. this chapter. (x) Arsenic (as As). Not more than 0.1 Breads, rolls (white & dark), 1.0 percent § 170.3(n)(1) of this chapter. part per million. Fruit pies, custard pies, § 170.3(n)(1) 7.0 percent (xi) Lead. Not more than 0.1 part per of this chapter. million. Cakes, § 170.3(n)(1) of this chapter .. 10.0 percent Cereals, § 170.3(n)(4) of this chapter 4.0 percent (3) Partially hydrogenated and hy- Fats, oils, § 170.3(n)(12) of this chap- 20.0 percent drogenated menhaden oils are used as ter, but not in infant formula. edible fats or oils, as defined in Yogurt, § 170.3(n)(31) of this chapter 4.0 percent § 170.3(n)(12) of this chapter, in food at Cheese products, § 170.3(n)(5) of 5.0 percent this chapter. levels not to exceed current good man- Frozen dairy products, § 170.3(n)(20) 5.0 percent ufacturing practice. of this chapter. (4) If the fat or oil is fully hydro- Meat products, § 170.3(n)(29) of this 10.0 percent chapter. genated, the name to be used on the Egg products, § 170.3(n)(11) of this 5.0 percent label of a product containing it shall chapter. include the term ‘‘hydrogenated,’’ or if Fish products, § 170.3(n)(13) of this 20.0 percent it is partially hydrogenated, the name chapter. Condiments, § 170.3(n)(8) of this 5.0 percent shall include the term ‘‘partially hy- chapter. drogenated,’’ in accordance with Soup mixes, § 170.3(n)(40) of this 3.0 percent § 101.4(b)(14) of this chapter. chapter. Snack foods, § 170.3(n)(37) of this 5.0 percent [62 FR 30756, June 5, 1997] chapter. Nut products, § 170.3(n)(32) of this 5.0 percent chapter. § 184.1490 Methylparaben. Gravies, sauces, § 170.3(n)(24) of 5.0 percent (a) Methylparaben is the chemical this chapter. methyl p-hydroxybenzoate. It is pro- (b) Hydrogenated and partially hydro- duced by the methanol esterification of genated menhaden oils. (1) Partially hy- p-hydroxybenzoic acid in the presence drogenated and hydrogenated menha- of sulfuric acid, with subsequent dis- den oils are prepared by feeding hydro- tillation. gen gas under pressure to a converter (b) The ingredient meets the speci- containing crude menhaden oil and a fications of the ‘‘Food Chemicals nickel catalyst. The reaction is begun Codex,’’ 3d Ed. (1981), p. 199, which is in- at 150 to 160 °C and after 1 hour the corporated by reference. Copies may be temperature is raised to 180 °C until obtained from the National Academy the desired degree of hydrogenation is Press, 2101 Constitution Ave. NW., reached. Hydrogenated menhaden oil is Washington, DC 20418, or may be exam- fully hydrogenated. ined at the Office of the Federal Reg- (2) Partially hydrogenated and hy- ister, 800 North Capitol Street, NW., drogenated menhaden oils meet the fol- suite 700, Washington, DC 20408. lowing specifications: (c) The ingredient is used as an anti- (i) Color. Opaque white solid. microbial agent as defined in (ii) Odor. Odorless. § 170.3(o)(2) of this chapter.

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(d) The ingredient is used in food at must be used in accordance with this levels not to exceed good manufac- requirement or its addition to food will turing practices. Current good manu- be considered by FDA to constitute the facturing practice results in a max- use of an unapproved food additive (see imum level of 0.1 percent in food. § 184.1(b)(2)). (e) Prior sanctions for this ingredient [55 FR 6391, Feb. 23, 1990] different from the uses established in this regulation do not exist or have § 184.1505 Mono- and diglycerides. been waived. (a) Mono- and diglycerides consist of [42 FR 14653, Mar. 15, 1977, as amended at 49 a mixture of glyceryl mono- and FR 5612, Feb. 14, 1984] diesters, and minor amounts of triesters, that are prepared from fats § 184.1498 Microparticulated protein or oils or fat-forming acids that are de- product. rived from edible sources. The most (a) Microparticulated protein product prevalent fatty acids include lauric, is prepared from egg whites or milk linoleic, myristic, oleic, palmitic, and protein or a combination of egg whites stearic. Mono- and diglycerides are and milk protein. These protein manufactured by the reaction of glyc- sources may be used alone or in com- erin with fatty acids or the reaction of bination with other safe and suitable glycerin with triglycerides in the pres- ingredients to form the ence of an alkaline catalyst. The prod- microparticulated product. The mix- ucts are further purified to obtain a ture of ingredients is high-shear heat mixture of glycerides, free fatty acids, processed to achieve a smooth and and free glycerin that contains at least creamy texture similar to that of fat. 90 percent-by-weight glycerides. Safe and suitable ingredients used in (b) The ingredient meets the speci- the preparation of the fications of the Food Chemicals Codex, microparticulated protein product 3d Ed. (1981), p. 201, which is incor- must be used in compliance with the porated by reference in accordance limitations of the appropriate regula- with 5 U.S.C. 552(a). Copies are avail- tions in parts 172, 182, and 184 of this able from the National Academy Press, chapter. 2101 Constitution Ave. NW., Wash- (b) The ingredient is used in food in ington, DC 20418, or available for in- accordance with § 184.1(b)(2) at levels spection at the Office of the Federal not to exceed current good manufac- Register, 800 North Capitol Street, turing practice. The affirmation of the NW., suite 700, Washington, DC 20005. use of this ingredient as generally rec- (c) In accordance with § 184.1(b)(1), ognized as safe (GRAS) as a direct the ingredient is used in food with no human food ingredient is based upon limitation other than current good the following conditions of use: manufacturing practice. The affirma- (1) The ingredient is used in food as a tion of this ingredient as generally rec- thickener as defined in § 170.3(o)(28) of ognized as safe (GRAS) as a direct this chapter or as a texturizer as de- human food ingredient is based upon fined in § 170.3(o)(32) of this chapter. the following current good manufac- (2) The ingredient is used in frozen turing practice conditions of use: dessert-type products except that the (1) The ingredient is used in food as a ingredient may not be used to replace dough strengthener as defined in the milk fat required in standardized § 170.3(o)(6) of this chapter; an emulsi- frozen desserts. fier and emulsifier salt as defined in (3) The name of the ingredient used § 170.3(o)(8) of this chapter; a flavoring in the ingredient statement on both agent and adjuvant as defined in bulk and packaged food must include § 170.3(o)(12) of this chapter; a formula- the source of the protein (e.g., tion aid as defined in § 170.3(o)(14) of ‘‘microparticulated egg white pro- this chapter; a lubricant and release tein’’), followed by a parenthetical list- agent as defined in § 170.3(o)(18) of this ing of each of the ingredients in the chapter; a solvent and vehicle as de- microparticulated protein product, in fined in § 170.3(o)(27) of this chapter; a descending order of predominance. stabilizer and thickener as defined in Microparticulated protein product § 170.3(o)(28) of this chapter; a surface-

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active agent as defined in §170.3(o)(29) this section do not exist or have been of this chapter; a surface-finishing waived. agent as defined in § 170.3(o)(30) of this [54 FR 7404, Feb. 21, 1989] chapter; and a texturizer as defined in § 170.3(o)(32) of this chapter. § 184.1530 Niacin. (2) The ingredient is used in food at levels not to exceed current good man- (a) Niacin (C6H5NO2, CAS Reg. No. 59– ufacturing practice. 67–6) is the chemical 3- (d) Prior sanctions for this ingredient pyridinecarboxylic acid (nicotinic different from the uses established in acid). It is a non-hygroscopic, stable, this section do not exist or have been white, crystalline solid that sublimes ° waived. without decomposition at about 230 C. It is soluble in water and alcohol. It is [54 FR 7403, Feb. 21, 1989, as amended at 57 insoluble in ether. FR 10616, Mar.27, 1992] (b) The ingredient meets the specifications of the ‘‘Food Chemicals § 184.1521 Monosodium phosphate derivatives of mono- and diglycerides. Codex,’’ 4th ed. (1996), p. 264, which is incorporated by reference in accord- (a) Monosodium phophate derivatives ance with 5 U.S.C. 552(a) and 1 CFR of mono- and diglycerides are com- part 51. Copies are available from the posed of glyceride derivatives formed National Academy Press, Box 285, 2101 by reacting mono- and diglycerides Constitution Ave. NW., Washington, that are derived from edible sources DC 20055 (Internet address http:// with phosphorus pentoxide www.nap.edu), or may be examined at (tetraphosphorus decoxide) followed by the Center for Food Safety and Applied neutralization with sodium carbonate. Nutrition’s Library, Food and Drug Ad- (b) FDA is developing food-grade ministration, 5100 Paint Branch Pkwy., specifications for monosodium phos- College Park, MD 20740, or at the Office phate mono- and diglycerides in co- of the Federal Register, 800 North Cap- operation with the National Academy itol St. NW., suite 700, Washington, DC. of Sciences. In the interim, this ingre- (c) In accordance with § 184.1(b)(1), dient must be of a purity suitable for the ingredient is used in food with no its intended use. limitation other than current good (c) In accordance with § 184.1(b)(1), manufacturing practice. The affirma- the ingredient is used in food with no tion of this ingredient as generally rec- limitation other than current good ognized as safe (GRAS) as direct manufacturing practice. The affirma- human food ingredient is based upon tion of this ingredient as generally rec- the following current good manufac- ognized as safe (GRAS) as a direct turing practice conditions of use: human food ingredient is based upon (1) The ingredient is used as a nutri- the following current good manufacturing practice conditions of use: ent supplement as defined in § 170.3(o)(20) of this chapter. (1) The ingredient is used in food as an emulsifier and emulsifier salt as de- (2) The ingredient is used in foods at fined in § 170.3(o)(8) of this chapter, a levels not to exceed current good man- lubricant and release agent as defined ufacturing practice. The ingredient in § 170.3(o)(18) of this chapter, and as a may also be used in infant formula in surface-active agent as defined in accordance with section 412(g) of the § 170.3(o)(29) of this chapter. Federal Food, Drug, and Cosmetic Act (2) The ingredient is used in the fol- (the Act) or with regulations promul- lowing foods at levels not to exceed gated under section 412(a)(2) of the Act. current good manufacturing practice: (d) Prior sanctions for this ingredient dairy product analogs as defined in different from the uses established in § 170.3(n)(10) of this chapter and soft this section do not exist or have been candy as defined in § 170.3(n)(38) of this waived. chapter. [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. (d) Prior sanctions for this ingredient 2, 1983, as amended at 64 FR 1760, Jan. 12, different from the uses established in 1999]

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§ 184.1535 Niacinamide. interim, this ingredient must be of a purity suitable for its intended use. (a) Niacinamide (C H N O, CAS Reg. 6 6 2 (c) In accordance with § 184.1(b)(1), No. 98–92–0) is the chemical 3- the ingredient is used in food with no pyridinecarboxylic acid amide (nicotin- limitation other than current good amide). It is a white crystalline powder manufacturing practice. The affirma- that is soluble in water, alcohol, ether, tion of this ingredient as generally rec- and glycerol. It melts between 128° and ° ognized as safe (GRAS) as a direct 131 C. human food ingredient is based upon (b) The ingredient meets the speci- the following current good manufac- fications of the Food Chemicals Codex, turing practice conditions of use: 3d Ed. (1981), p. 205, which is incor- (1) The ingredient is used as a cata- porated by reference. Copies are avail- lyst as defined in § 170.3(o)(24) of this able from the National Academy Press, chapter. 2101 Constitution Ave. NW., Wash- (2) The ingredient is used in the hy- ington, DC 20418, or available for in- drogenation of fats and oils as defined spection at the Office of the Federal in § 170.3(n)(12) of this chapter at levels Register, 800 North Capitol Street, not to exceed current good manufac- NW., suite 700, Washington, DC 20408. turing practice. Current good manufac- (c) In accordance with § 184.1(b)(1), turing practice includes the removal of the ingredient is used in food with no nickel from fats and oils following hy- limitation other than current good drogenation. manufacturing practice. The affirma- (d) Prior sanctions for this ingredient tion of this ingredient as generally rec- different from the uses established in ognized as safe (GRAS) as a direct this section do not exist or have been human food ingredient is based upon waived. the following current good manufacturing practice conditions of use: [48 FR 51618, Nov. 10, 1983] (1) The ingredient is used as a nutri- § 184.1538 Nisin preparation. ent supplement as defined in § 170.3(o)(20) of this chapter. (a) Nisin preparation is derived from (2) The ingredient is used in foods at pure culture fermentations of certain levels not to exceed current good man- strains of Streptococcus lactis ufacturing practice. The ingredient Lancefield Group N. Nisin preparation may also be used in infant formula in contains nisin (CAS Reg. No. 1414–45–5), accordance with section 412(g) of the a group of related peptides with anti- Federal Food, Drug, and Cosmetic Act biotic activity. (the act) or with regulations promul- (b) The ingredient is a concentrate or gated under section 412(a)(2) of the Act. dry material that meets the specifica- (d) Prior sanctions for this ingredient tions that follow when it is tested as different from the uses established in described in ‘‘Specifications for Iden- this section do not exist or have been tity and Purity of Some Antibiotics,’’ waived. World Health Organization, FAO Nutri- tion Meeting Report Series, No. 45A, [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. 1969, which is incorporated by ref- 2, 1983] erence. Copies are available from the Division of Dockets Management § 184.1537 Nickel. (HFA–305), Food and Drug Administra- (a) Elemental nickel (CAS Reg. No. tion, 5630 Fishers Lane, rm. 1061, Rock- 7440–02–0) is obtained from nickel ore ville, MD 20852, or available for inspec- by transforming it to nickel sulfide tion at the Office of the Federal Reg- (Ni3S2). The sulfide is roasted in air to ister, 800 North Capitol Street, NW., give nickel oxide (NiO). The oxide is suite 700, Washington, DC 20408. then reduced with carbon to give ele- (1) Nisin content, not less than 900 mental nickel. international units per milligram. (b) The Food and Drug Administra- (2) Arsenic, not more than 1 part per tion is developing food-grade specifica- million. tions for nickel in cooperation with the (3) Lead, not more than 2 parts per National Academy of Sciences. In the million.

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(4) Zinc, not more than 25 parts per the National Academy of Sciences. In million. the interim, the ingredient must be of (5) Copper, zinc plus copper not more a purity suitable for its intended use. than 50 parts per million. (c) In accordance with § 184.1(b)(1), (6) Total plate count, not more than the ingredient is used in food with no 10 per gram. limitations other than current good (7) Escherichia coli, absent in 10 manufacturing practice. The affirma- grams. tion of this ingredient as generally rec- (8) Salmonella, absent in 10 grams. ognized as safe (GRAS) as a direct (9) Coagulase positive staphylococci, human food ingredient is based upon absent in 10 grams. the following current good manufac- (c) The ingredient is used as an anti- turing practice conditions of use: microbial agent as defined in (1) The ingredient is used as a propel- § 170.3(o)(2) of this chapter to inhibit lant, aerating agent, and gas as defined the outgrowth of Clostridium botulinum in § 170.3(o)(25) of this chapter. spores and toxin formation in pasteur- (2) The ingredient is used in food at ized cheese spreads and pasteurized levels not to exceed current good man- process cheese spreads listed in ufacturing practice. § 133.175; pasteurized cheese spread with (d) Prior sanctions for this ingredient fruits, vegetables, or meats as defined different from the uses established in in § 133.176; pasteurized process cheese this section do not exist or have been spread as defined in § 133.179; pasteur- waived. ized process cheese spread with fruits, [48 FR 57270, Dec. 29, 1983] vegetables, or meats as defined in § 133.180 of this chapter. § 184.1545 Nitrous oxide. (d) The ingredient is used at levels (a) Nitrous oxide (empirical formula not to exceed good manufacturing N2O, CAS Reg. No. 10024–97–2) is also practice in accordance with § 184.1(b)(1) known as dinitrogen monoxide or of this chapter. The current good man- laughing gas. It is a colorless gas, ufacturing practice level is the quan- about 50 percent heavier than air, with tity of the ingredient that delivers a a slightly sweet smell. It does not burn maximum of 250 parts per million of but will support combustion. Nitrous nisin in the finished product as deter- oxide is manufactured by the thermal mined by the British Standards Insti- decomposition of ammonium nitrate. tution Methods, ‘‘Methods for the Esti- Higher oxides of nitrogen are removed mation and Differentiation of Nisin in by passing the dry gas through a series Processed Cheese,’’ BS 4020 (1974), of scrubbing towers. which is incorporated by reference. (b) The Food and Drug Administra- Copies are available from the Division tion is developing food-grade specifica- of Dockets Management (HFA–305), tions for nitrous oxide in cooperation Food and Drug Administration, rm. 1– with the National Academy of 23, 12420 Parklawn Dr., Rockville, MD Sciences. In the interim, the ingredient 20857, or available for inspection at the must be of a purity suitable for its in- Office of the Federal Register, 800 tended use. North Capitol Street, NW., suite 700, (c) In accordance with § 184.1(b)(1), Washington, DC 20408. the ingredient is used in food with no [53 FR 11250, Apr. 6, 1988, as amended at 59 limitations other than current good FR 14364, Mar. 28, 1994; 68 FR 24879, May 9, manufacturing practice. The affirma- 2003] tion of this ingredient as generally recognized as safe (GRAS) as a direct § 184.1540 Nitrogen. human food ingredient is based upon (a) Nitrogen (empirical formula N2, the following current good manufac- CAS Reg. No. 7727–37–9) is a colorless, turing practice conditions of use: odorless, flavorless gas that is pro- (1) The ingredient is used as a propel- duced commercially by the fraction- lant, aerating agent, and gas as defined ation of liquid air. in § 170.3(o)(25) of this chapter. (b) The Food and Drug Administra- (2) The ingredient is used in dairy tion is developing food-grade specifica- product analogs as defined in tions for nitrogen in cooperation with § 170.3(n)(10) of this chapter at levels

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not to exceed current good manufac- mixture of triglycerides in which the turing practice. fatty acid composition is a mixture of (d) Prior sanctions for this ingredient saturated fatty acids. The fatty acids different from the uses established in are present in the same porportions this section do not exist or have been which result from the full hydro- waived. genation of fatty acids occurring in [48 FR 57270, Dec. 29, 1983] natural rapeseed oil. The rapeseed oil is obtained from the napus and § 184.1553 Peptones. campestris varieties of Brassica of the (a) Peptones are a variable mixture family Cruciferae. It is prepared by of polypeptides, oligopeptides, and fully hydrogenating refined and ° amino acids that are produced by par- bleached rapeseed oil at 310–375 F, tial hydrolysis of casein, animal tissue, using a catalyst such as nickel, until soy protein isolate, gelatin, defatted the iodine number is 4 or less. fatty tissue, egg albumin, or lactal- (2) The ingredient meets the fol- bumin (whey protein). Peptones are lowing specifications: Acid value not produced from these proteins using more than 6, arsenic not more than 3 proteolytic enzymes that either are parts per million, free glycerin not considered to be generally recognized more than 7 percent, heavy metals (as as safe (GRAS) or are regulated as food Pb) not more than 10 parts per million, additives. Peptones are also produced iodine number not more than 4, residue by denaturing any of the proteins list- on ignition not more than 0.5 percent. ed in this paragraph with safe and suit- (3) The ingredient is used as a sta- able acids or heat. bilizer and thickener as defined in (b) FDA is developing food-grade § 170.3(o)(28) of this chapter in peanut specifications for peptones in coopera- butter. The use level of the ingredient tion with the National Academy of is limited by good manufacturing prac- Sciences. In the interim, these ingredi- tice (GMP) to the minimum amount re- ents must be of a purity suitable for quired to produce the intended effect. their intended use. Current good manufacturing practices (c) In accordance with § 184.1(b)(1), result in a maximum level of 2 percent these ingredients are used in food with in peanut butter. no limitation other than current good (b) Superglycerinated fully hydro- manufacturing practice. The affirma- genated rapeseed oil. (1) tion of these ingredients as GRAS as Superglycerinated fully hydrogenated direct human food ingredients is based rapeseed oil is a mixture of mono- and upon the following current good manu- diglycerides with triglycerides as a facturing practice conditions of use: minor component. The fatty acid com- (1) These ingredients are used as nu- position is a mixture of saturated fatty trient supplements as defined in acids present in the same proportions § 170.3(o)(20) of this chapter; as proc- as those resulting from the full hydro- essing aids as defined in § 170.3(o)(24) of genation of fatty acids in natural this chapter; and as surface-active rapeseed oil. It is made by adding ex- agents as defined in § 170.3(o)(29) of this cess glycerol to the fully hydrogenated chapter. rapeseed oil and heating, in the pres- (2) These ingredients are used in food ence of a sodium hydroxide catalyst, to at levels not to exceed current good 330 °F under partial vacuum and steam manufacturing practice. sparging agitation. (d) Prior sanctions for these ingredi- (2) The ingredient meets the speci- ents different from the uses established fications of the ‘‘Food Chemicals in this section do not exist or have Codex,’’ 3d Ed. (1981), p. 201, relating to been waived. mono- and diglycerides, which is incor- [49 FR 25430, June 21, 1984, as amended at 50 porated by reference. Copies may be FR 49536, Dec. 3, 1985] obtained from the National Academy Press, 2101 Constitution Ave. NW., § 184.1555 Rapeseed oil. Washington, DC 20418, or may be exam- (a) Fully hydrogenated rapeseed oil. (1) ined at the Office of the Federal Reg- Fully hydrogenated rapeseed oil is a ister, 800 North Capitol Street, NW.,

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suite 700, Washington, DC 20408. An ad- § 184.1560 Ox bile extract. ditional specification requires the iodine number to be 4 or less. (a) Ox bile extract (CAS Reg. No. (3) The ingredient is used as an emul- 8008–63–7), also known as purified sifier as defined in § 170.3(o)(8) of this oxgall or sodium choleate, is a yel- chapter in shortenings for cake mixes. lowish green, soft solid, with a partly The use level of the ingredient is lim- sweet, partly bitter, disagreeable taste. ited by good manufacturing practice It is the purified portion of the bile of (GMP) to the minimum amount re- an ox obtained by evaporating the alco- quired to produce the intended effect. hol extract of concentrated bile. Current good manufacturing practices (b) Food-grade ox bile extract shall result in a maximum level, as served, meet the specifications of the U.S. of 4 percent of the shortening or 0.5 Pharmacopeia (USP), XIV, 1950, p. 410. 1 percent of the total weight of the cake (c) The ingredient is used as a surfac- mix. tant as defined in § 170.3 (o)(29) of this (c) Low erucic acid rapeseed oil. (1) chapter. Low erucic acid rapeseed oil, also (d) The ingredient is used in food in known as canola oil, is the fully re- accordance with § 184.1(b)(1) at levels fined, bleached, and deodorized edible not to exceed good manufacturing oil obtained from certain varieties of practice. Current good manufacturing Brassica Napus or B. Campestris of the family Cruciferae. The plant varieties practice results in a maximum level, as are those producing oil-bearing seeds served, of 0.002 percent for cheese as de- with a low erucic acid content. Chemi- fined in § 170.3(n)(5) of this chapter. cally, low erucic acid rapeseed oil is a (e) Prior sanctions for this ingredient mixture of triglycerides, composed of different from the uses established in both saturated and unsaturated fatty this section do not exist or have been acids, with an erucic acid content of no waived. more than 2 percent of the component [43 FR 36064, Aug. 15, 1978. Redesignated and fatty acids. amended at 50 FR 49537, Dec. 3, 1985] (2) Low erucic acid rapeseed oil as defined in paragraph (c)(1) of this section § 184.1563 Ozone. may be partially hydrogenated to reduce the proportion of unsaturated (a) Ozone (O3, CAS Reg. No. 10028–15– fatty acids. When the partially hydro- 6) is an unstable blue gas with a pun- genated low erucic acid rapeseed oil is gent, characteristic odor, which occurs used, it shall be referred to as partially freely in nature, It is produced com- hydrogenated low erucic acid rapeseed mercially by passing electrical dis- oil. charges or ionizing radiation through (3) In addition to limiting the con- air or oxygen. tent of erucic acid to a level not ex- (b) The ingredient must be of a pu- ceeding 2 percent of the component rity suitable for its intended use in ac- fatty acids, FDA is developing other cordance with § 170.30(h)(1) of this chap- food-grade specifications for low erucic ter. acid rapeseed oil and partially hydro- (c) In accordance with § 184.1(b)(2), genated low erucic acid rapeseed oil in the ingredient is used to treat food cooperation with the National Acad- only within the following specific limi- emy of Sciences. In the interim, the in- tations: gredients must be of a purity suitable for their intended use. (4) Low erucic acid rapeseed oil and partially hydrogenated low erucic acid rapeseed oil are used as edible fats and oils in food, except in infant formula, at levels not to exceed current good manufacturing practice. [42 FR 48336, Sept. 23, 1977, as amended at 49 1 Copies may be obtained from: U.S. FR 5613, Feb. 14, 1984; 50 FR 3755, Jan. 28, Pharmacopeial Convention, Inc., 12601 1985; 53 FR 52682, Dec. 29, 1988] Twinbrook Parkway, Rockville, MD 20852.

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Maximum treat- § 184.1585 Papain. Category of food ment level in food Functional use (a) Papain (CAS Reg. No. 9001–73–4) is Bottled water that Not to exceed cur- Antimicrobial a proteolytic enzyme derived from prior to ozonation rent good man- agent, § 170.3 Carica papaya L. Crude latex con- meets the micro- ufacturing prac- (o)(2) of this biological, phys- tice. Current chapter. taining the enzyme is collected from ical, chemical, good manufac- slashed unripe papaya. The food-grade and radiological turing practice product is obtained by repeated filtra- quality standards results in a of § 165.110 maximum resid- tion of the crude latex or an aqueous (b)(2) through ual level at the solution of latex or by precipitation (b)(5) of this time of bottling from an aqueous solution of latex. The chapter. of 0.4 milligram resulting enzyme preparation may be of ozone per liter of bottled used in a liquid or dry form. water. (b) The ingredient meets the specifications of the Food Chemicals Codex, [47 FR 50210, Nov. 5, 1982, as amended at 60 3d Ed. (1981), pp. 107–110, which is incor- FR 57130, Nov. 13, 1995] porated by reference. Copies are available from the National Academy Press, § 184.1583 Pancreatin. 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- (a) Pancreatin (CAS Reg. No. 8049–47– spection at the Office of the Federal 6) is an enzyme preparation obtained Register, 800 North Capitol Street, from porcine or bovine pancreatic tis- NW., suite 700, Washington, DC 20408. sue. It is a white to tan powder. Its (c) In accordance with § 184.1(b)(1), characterizing enzyme activity that of the ingredient is used in food with no a peptide hydrolase (EC 3.4.21.36). limitation other than currect good (b) The ingredient meets the general manufacturing practice. The affirma- requirements and additional require- tion of this ingredient as generally rec- ments in the Food Chemicals Codex, 3d ognized as safe (GRAS) as a direct ed. (1981), p. 110, which is incorporated human food ingredient is based upon by reference in accordance with 5 the following current good manufac- U.S.C. 552(a) and 1 CFR part 51. Copies turing conditions of use: are available from the National Acad- (1) The ingredient is used as an en- emy Press, 2101 Constitution Ave. NW., zyme as defined in § 170.3(o)(9) of this Washington, DC 20418, or may be exam- chapter; processing aid as defined in ined at the Office of Premarket Ap- § 170.3(o)(24) of this chapter; and proval (HFS–200), Food and Drug Ad- texturizer as defined in § 170.3(o)(32) of ministration, 5100 Paint Branch Pkwy., this chapter. College Park, MD 20740, and the Office (2) The ingredient is used in food at of the Federal Register, 800 North Cap- levels not to exceed current good man- itol St. NW., suite 700, Washington, DC. ufacturing practice. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the uses established in the ingredient is used in food with no this section do not exist or have been limitation other than current good waived. manufacturing practice. The affirmation of this ingredient as GRAS as a di- [48 FR 48806, Oct. 21, 1983] rect food ingredient is based upon the § 184.1588 Pectins. following current good manufacturing practice conditions of use: (a) The pectins (CAS Reg. No. 9000– (1) The ingredient is used as an en- 69–5) are a group of complex, high mo- zyme as defined in § 170.3(o)(9) of this lecular weight polysaccharides found chapter to hydrolyze proteins or in plants and composed chiefly of partially methylated polygalacturonic polypeptides. acid units. Portions of the carboxly (2) The ingredient is used in food at group occur as methyl esters, and the levels not to exceed current good man- remaining carboxyl groups exist in the ufacturing practice. form of the free acid or as its ammo- [60 FR 32911, June 26, 1995] nium, potassium, or sodium (CAS Reg. No. 9000–59–8) salts, and in some types

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as the acid amide. Thus, the pectins ments for enzyme preparations in the regulated in this section are the high- Food Chemicals Codex, 3d ed. (1981), p. ester pectins, low-ester pectins, 110, which is incorporated by reference amidated pectins, pectinic acids, and in accordance with 5 U.S.C. 552(a) and 1 pectinates. Pectin is produced commer- CFR part 51. Copies are available from cially by extracting citrus peel, apple the National Academy Press, 2101 Con- pomace, or beet pulp with hot dilute stitution Ave. NW., Washington, DC ° ° acid (pH 1.0 to 3.5, 70 to 90 C). The ex- 20418, or may be examined at the Office tract is filtered, and pectin is then pre- of Premarket Approval (HFS–200), Food cipitated from the clear extract with and Drug Administration, 5100 Paint ethanol or isopropanol, or as the copper or aluminum salt. The acid extract Branch Pkwy., College Park, MD 20740, is sometimes spray- or roller-dried, or and the Office of the Federal Register, it is concentrated to be sold as liquid 800 North Capitol St. NW., suite 700, pectin. Washington, DC. (b) The ingredients meet the speci- (c) In accordance with § 184.1(b)(1), fications of the Food Chemical Codex, the ingredient is used in food with no 3d Ed. (1981), p. 215, which is incor- limitation other than current good porated by reference. Copies are avail- manufacturing practice. The affirma- able from the National Academy Press, tion of this ingredient as GRAS as a di- 2101 Constitution Ave. NW., Wash- rect food ingredient is based upon the ington, DC 20418, or available for in- following current good manufacturing spection at the Office of the Federal practice conditions of use: Register 800 North Capitol Street, NW., (1) The ingredient is used as an en- suite 700, Washington, DC 20408. zyme as defined in § 170.3(o)(9) of this (c) In accordance with § 184.1(b)(1), chapter to hydrolyze proteins or the ingredients are used in food with polypeptides. no limitation other than current good manufacturing practice. The affirma- (2) The ingredient is used in food at tion of these ingredients as generally levels not to exceed current good man- recognized as safe (GRAS) as direct ufacturing practice. human food ingredients is based upon [60 FR 32911, June 26, 1995] the following current good manufacturing practice conditions of use: § 184.1610 Potassium alginate. (1) The ingredients are used as emulsifiers as defined in § 170.3(o)(8) of this (a) Potassium alginate (CAS Reg. No. chapter and as stabilizers and thick- 9005–36–1) is the potassium salt of al- eners as defined in § 170.3(o)(28) of this ginic acid, a natural polyuronide con- chapter. stituent of certain brown algae. Potas- (2) The ingredients are used in food sium alginate is prepared by the neu- at levels not to exceed current good tralization of purified alginic acid with manufacturing practice. appropriate pH control agents. (d) Prior sanctions for these ingredi- (b) The ingredient meets the speci- ents different from the uses established fications of the Food Chemicals Codex, in this section do not exist or have 3d Ed. (1981), p. 239, which is incor- been waived. porated by reference. Copies are avail- [48 FR 51149, Nov. 7, 1983] able from the National Academy Press, 2101 Constitution Ave. NW., Wash- § 184.1595 Pepsin. ington, DC 20418, or available for in- (a) Pepsin (CAS Reg. No. 9001–75–6) is spection at the Office of the Federal an enzyme preparation obtained from Register, 800 North Capitol Street, the glandular layer of hog stomach. It NW., suite 700, Washington, DC 20408. is a white to light tan powder, amber (c) In accordance with § 184.1(b)(2), paste, or clear amber to brown liquid. the ingredient is used in food only Its characterizing enzyme activity is within the following specific limita- that of a peptide hydrolase (EC tions: 3.4.23.1). (b) The ingredient meets the general requirements and additional require-

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Maximum (2) The ingredient is used in food at level of use in levels not to exceed current good man- Category of food food (as Functional use ufacturing practice. served) (percent) (d) Prior sanctions for this ingredient different from the uses established in Confections and 0.1 Stabilizer, thickener, this section do not exist or have been frostings, § 170.3(o)(28) of this § 170.3(n)(9) of this chapter waived. chapter. [48 FR 52442, Nov. 18, 1983] Gelatins and puddings, 0.7 Do. § 170.3(n)(22) of this chapter. § 184.1619 Potassium carbonate. Processed fruits and 0.25 Do. fruit juices, (a) Potassium carbonate (K2CO3, CAS § 170.3(n)(35) of this Reg. No. 584–08–7) is produced by the chapter. following methods of manufacture: All other food cat- 0.01 Do. egories. (1) By electrolysis of potassium chloride followed by exposing the resultant (d) Prior sanctions for potassium al- potassium to carbon dioxide; ginate different from the uses estab- (2) By treating a solution of potas- lished in this section do not exist or sium hydroxide with excess carbon di- have been waived. oxide to produce potassium carbonate; (3) By treating a solution of potas- [47 FR 29951, July 9, 1982] sium hydroxide with carbon dioxide to § 184.1613 Potassium bicarbonate. produce potassium bicarbonate, which is then heated to yield potassium car- (a) Potassium bicarbonate (KHCO3, bonate. CAS Reg. No. 298–14–6) is made by the (b) The ingredient meets the speci- following processes: fications of the Food Chemicals Codex, (1) By treating a solution of potas- 3d Ed. (1981), p. 240, which is incor- sium hydroxide with carbon dioxide; porated by reference. Copies are avail- (2) By treating a solution of potas- able from the National Academy Press, sium carbonate with carbon dioxide. 2101 Constitution Ave. NW., Wash- (b) The ingredient meets the speci- ington, D.C. 20418, or available for in- fications of the Food Chemicals Codex, spection at the Office of the Federal 3d Ed. (1981), p. 239, which is incor- Register, 800 North Capitol Street, porated by reference. Copies are avail- NW., suite 700, Washington, DC 20408. able from the National Academy Press, (c) In accordance with § 184.1(b)(1), 2101 Constitution Ave. NW., Wash- the ingredient is used in food with no ington, DC 20418, or available for in- limitation other than current good spection at the Office of the Federal manufacturing practice. the affirma- Register, 800 North Capitol Street, tion of this ingredient as generally rec- NW., suite 700, Washington, DC 20408. ognized as safe (GRAS) as a direct (c) In accordance with § 184.1(b)(1), human food ingredient is based upon the ingredient is used in food with no the following current good manufac- limitation other than current good turing practice conditions of use: manufacturing practice. The affirmation of this ingredient as generally rec- (1) The ingredient is used in food as a ognized as safe (GRAS) as a direct flavoring agent and adjuvant as defined human food ingredient is based upon in § 170.3(o)(12) of this chapter; nutrient the following current good manufac- supplement as defined in § 170.3(o)(20) of turing practice conditions of use: this chapter; pH control agent as de- (1) The ingredient is used as a formu- fined in § 170.3(o)(23) of this chapter; lation aid as defined in § 170.3(o)(14) of and processing aid as defined in this chapter; nutrient supplemlent as § 170.3(o)(24) of this chapter. defined in § 170.3(o)(20) of this chapter; (2) The ingredient is used in food at pH control agent as defined in levels not to exceed current good man- § 170.3(o)(23) of this chapter; and proc- ufacturing practice. essing aid as defined in § 170.3(o)(24) of (d) Prior sanctions for this ingredient this chapter. different from the uses established in

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this section do not exist or have been tassium salt of citric acid. It is pre- waived. pared by neutralizing citric acid with potassium hydroxide or potassium car- [48 FR 52442, Nov. 18, 1983] bonate. It occurs as transparent crys- § 184.1622 Potassium chloride. tals or a white granular powder, is odorless and deliquescent, and contains (a) Potassium chloride (KCl, CAS one mole of water per mole of potas- Reg. No. 7447–40–7) is a white, odorless sium citrate. solid prepared from source minerals by (b) The ingredient meets the speci- fractional crystallization or flotation. fications of the Food Chemicals Codex, It is soluble in water and glycerol and 3d ed. (1981), p. 242, which is incor- has a saline taste at low concentration porated by reference in accordance levels. with 5 U.S.C. 552(a) and 1 CFR part 51. (b) The ingredient meets the speci- Copies are available from the National fications of the Food Chemicals Codex, Academy Press, 2101 Constitution Ave. 3d Ed. (1981), p. 241, which is incor- NW., Washington, DC 20418, and the porated by reference. Copies are avail- Center for Food Safety and Applied Nu- able from the National Academy Press, trition (HFS–200), 5100 Paint Branch 2101 Constitution Ave. NW., Wash- Pkwy., College Park, MD 20740, or may ington, DC 20418, or available for in- be examined at the Office of the Fed- spection at the Office of the Federal eral Register, 800 North Capitol St. Register, 800 North Capitol Street, NW., suite 700, Washington, DC. NW., suite 700, Washington, DC 20408. (c) In accordance with § 184.1(b)(1), (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no the ingredient is used in food with no limitation other than current good limitation other than current good manufacturing practice. manufacturing practice. The affirma- (d) Prior sanctions for this ingredient tion of this ingredient as generally rec- different from the uses established in ognized as safe (GRAS) as a direct this section, or different from those set human food ingredient is based upon forth in part 181 of this chapter, do not the following current good manufac- exist or have been waived. turing practice conditions of use: (1) The ingredient is used as a flavor [59 FR 63896, Dec. 12, 1994] enhancer as defined in § 170.3(o)(11) of § 184.1631 Potassium hydroxide. this chapter; as a flavoring agent as defined in § 170.3(o)(12) of this chapter; as (a) Potassium hydroxide (KOH, CAS a nutrient supplement as defined in Reg. No. 1310–58–3) is also known as § 170.3(o)(20) of this chapter; as a pH caustic potash, potash lye, and potassa. control agent as defined in §170.3(o)(23) The empirical formula is KOH. It is a of this chapter; and as a stabilizer or white, highly deliquescent caustic thickener as defined in § 170.3(o)(28) of solid, which is marketed in several this chapter. forms, including pellets, flakes, sticks, (2) The ingredient is used in food at lumps, and powders. Potassium hydrox- levels not to exceed current good man- ide is obtained commercially from the ufacturing practice. Potassium chlo- electrolysis of potassium chloride solu- ride may be used in infant formula in tion in the presence of a porous dia- accordance with section 412(g) of the phragm. (b) The ingredient meets the speci- Federal Food, Drug, and Cosmetic Act fications of the Food Chemicals Codex, (the Act) or with regulations promul- 3d Ed. (1981), which is incorporated by gated under section 412(a)(2) of the Act. reference. Copies are available from (d) Prior sanctions for this ingredient the National Academy Press, 2101 Con- different from the uses established in stitution Ave. NW., Washington, DC this section do not exist or have been 20418, or available from inspection at waived. the Office of the Federal Register, 800 [48 FR 51614, Nov. 10, 1983] North Capitol Street, NW., suite 700, Washington, DC 20408. § 184.1625 Potassium citrate. (c) In accordance with § 184.1(b)(1), (a) Potassium citrate (C6H5K3O7·H2O, the ingredient is used in food with no CAS Reg. No. 006100–0905–096) is the po- limitation other than current good

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manufacturing practice. The affirma- § 184.1635 Potassium iodate. tion of this ingredient as generally rec- (a) Potassium iodate (KIO3, CAS Reg. ognized as safe (GRAS) as a direct No. 7758–05–6) does not occur naturally human food ingredient is based upon but can be prepared by reacting iodine the following current good manufac- with potassium hydroxide. turing practice conditions of use: (b) The ingredient meets the speci- (1) The ingredient is used as a formu- fications of the ‘‘Food Chemicals lation aid as defined in § 170.3(o)(14) of Codex,’’ 3d Ed. (1981), pp. 245–246, which this chapter; a pH control agent as de- is incorporated by reference. Copies fined in § 170.3(o)(23) of the chapter; a may be obtained from the National processing aid as defined in § 170.3(o)(24) Academy Press, 2101 Constitution Ave. of this chapter; and a stabilizer and NW., Washington, DC 20418, or may be thickener as defined in § 170.3(o)(28) of examined at the Office of the Federal this chapter. Register, 800 North Capitol Street, (2) The ingredient is used in food at NW., suite 700, Washington, DC 20408. levels not to exceed current good man- (c) The ingredient is used as a dough ufacturing practice. strengthener as defined in § 170.3(o)(6) (d) Prior sanctions for this ingredient of this chapter. different from the uses established in (d) The ingredient is used in the man- this section do not exist or have been ufacture of bread in accordance with waived. § 184.1(b)(2) of this chapter in an amount not to exceed 0.0075 percent [48 FR 52444, Nov. 18, 1983] based on the weight of the flour. (e) Prior sanctions for this ingredient § 184.1634 Potassium iodide. different from the uses established in (a) Potassium iodide (KI, CAS Reg. this section do not exist or have been No. 7681–11–0) is the potassium salt of waived. hydriodic acid. It occurs naturally in [43 FR 11699, Mar. 21, 1978, as amended at 49 sea water and in salt deposits, but can FR 5613, Feb. 14, 1984] be prepared by reacting hydriodic acid (HI) with potassium bicarbonate § 184.1639 Potassium lactate.

(KHCO3). (a) Potassium lactate (C3H5O3K, CAS (b) The ingredient meets the speci- Reg. No. 996–31–6) is the potassium salt fications of the ‘‘Food Chemicals of lactic acid. It is a hydroscopic, Codex,’’ 3d Ed. (1981), pp. 246–247, which white, odorless solid and is prepared is incorporated by reference. Copies commercially by the neutralization of may be obtained from the National lactic acid with potassium hydroxide. Academy Press, 2101 Constitution Ave. (b) FDA is developing food-grade NW., Washington, DC 20418, or may be specifications for potassium lactate in examined at the Office of the Federal cooperation with the National Acad- Register, 800 North Capitol Street, emy of Sciences. In the interim, this NW., suite 700, Washington, DC 20408. ingredient must be of a purity suitable (c) The ingredient is used as a nutri- for its intended use. ent supplement as defined in (c) In accordance with § 184.1(b)(1), § 170.3(o)(20) of this chapter. the ingredient is used in food with no (d) The ingredient is used in table limitation other than current good salt in accordance with § 184.1(b)(2) of manufacturing practice. This regula- this chapter as a source of dietary io- tion does not authorize its use in infant foods and infant formulas. The af- dine at a maximum level of 0.01 per- firmation of this ingredient as gen- cent. erally recognized as safe (GRAS) as a (e) Prior sanctions for this ingredient direct human food ingredient is based different from the uses established in upon the following current good manu- this section do not exist or have been facturing practice conditions of use: waived. (1) The ingredient is used as a flavor [43 FR 11699, Mar. 21, 1978, as amended at 49 enhancer as defined in § 170.3(o)(11) of FR 5613, Feb. 14, 1984; 61 FR 14247, Apr. 1, this chapter; a flavoring agent or adju- 1996] vant as defined in § 170.3(o)(12) of this

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chapter; a humectant as defined in shipped in the liquid state. Propane is § 170.3(o)(16) of this chapter; and a pH obtained from natural gas by fraction- control agent as defined in § 170.3(o)(23) ation following absorption in oil, ad- of this chapter. sorption to surface-active agents, or re- (2) The ingredient is used in food at frigeration. levels not to exceed current good man- (b) The Food and Drug Administra- ufacturing practice. tion is developing food-grade specifica- (d) Prior sanctions for this ingredient tions for propane in cooperation with different from the uses established in the National Academy of Sciences. In this section do not exist or have been the interim, the ingredient must be of waived. a purity suitable for its intended use. [52 FR 10886, Apr. 6, 1987] (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no § 184.1643 Potassium sulfate. limitations other than current good manufacturing practice. The affirma- (a) Potassium sulfate (K2SO4, CAS Reg. No. 7778–80–5) occurs naturally and tion of this ingredient as generally rec- consists of colorless or white crystals ognized as safe (GRAS) as a direct or crystalline powder having a bitter, human food ingredient is based upon saline taste. It is prepared by the neu- the following current good manufac- tralization of sulfuric acid with potas- turing practice conditions of use: sium hydroxide or potassium car- (1) The ingredient is used as a propel- bonate. lant, aerating agent, and gas as defined (b) The ingredient meets the speci- in § 170.3(o)(25) of this chapter. fications of the ‘‘Food Chemicals (2) The ingredient is used in food at Codex,’’ 3d Ed. (1981), p. 252, which is in- levels not to exceed current good man- corporated by reference. Copies may be ufacturing practice. obtained from the National Academy (d) Prior sanctions for this ingredient Press, 2101 Constitution Ave. NW., different from the uses established in Washington, DC 20418, or may be exam- this section do not exist or have been ined at the Office of the Federal Reg- waived. ister, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [48 FR 57271, Dec. 29, 1983] (c) The ingredient is used as a flavoring agent and adjuvant as defined in § 184.1660 Propyl gallate. § 170.3(o)(12) of this chapter. (a) Propyl gallate is the n- (d) The ingredient is used in food at propylester of 3,4,5-trihydroxybenzoic levels not to exceed good manufac- acid (C10H12O5). Natural occurrence of turing practice in accordance with propyl gallate has not been reported. It § 184.1(b)(1). Current good manufac- is commercially prepared by turing practice results in a maximum esterification of gallic acid with propyl level, as served, of 0.015 percent for alcohol followed by distillation to re- nonalcoholic beverages as defined in move excess alcohol. § 170.3(n)(3) of this chapter. (b) The ingredient meets the speci- (e) Prior sanctions for this ingredient fications of the ‘‘Food Chemicals different from the uses established in Codex,’’ 3d Ed. (1981), pp. 257–258, which this section do not exist or have been is incorporated by reference. Copies waived. may be obtained from the National [45 FR 6086, Jan. 25, 1980, as amended at 49 Academy Press, 2101 Constitution Ave. FR 5613, Feb. 14, 1984] NW., Washington, DC 20418, or may be examined at the Office of the Federal § 184.1655 Propane. Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (a) Propane (empirical formula C3H8, CAS Reg. No. 74–98–6) is also known as (c) The ingredient is used as an anti- dimethylmethane or propyl hydrid. It oxidant as defined in § 170.3(o)(3) of this is a colorless, odorless, flammable gas chapter. at normal temperatures and pressures. (d) The ingredient is used in food at It is easily liquefied under pressure at levels not to exceed good manufac- room temperature and is stored and turing practice in accordance with

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§ 184.1(b)(1). Good manufacturing prac- ufacturing practice in accordance with tice results in a maximum total con- § 184.1(b)(1). Current good manufac- tent of antioxidants of 0.02 percent of turing practice results in maximum the fat or oil content, including the es- levels, as served, of 5 percent for alco- sential (volatile) oil content, of the holic beverages, as defined in food. § 170.3(n)(2) of this chapter; 24 percent (e) Prior sanctions for this ingredient for confections and frostings as defined different from the uses established in in § 170.3(n)(9) of this chapter; 2.5 per- this section, or different from that cent for frozen dairy products as de- stated in part 181 of this chapter, do fined in § 170.3(n)(20) of this chapter; 97 not exist or have been waived. percent for seasonings and flavorings [42 FR 14653, Mar. 15, 1977, as amended at 44 as defined in § 170.3(n)(26) of this chap- FR 52826, Sept. 11, 1979; 49 FR 5613, Feb. 14, ter; 5 percent for nuts and nut products 1984] as defined in § 170.3(n)(32) of this chapter; and 2.0 percent for all other food § 184.1666 Propylene glycol. categories.

(a) Propylene glycol (C3H8O2, CAS (e) Prior sanctions for this ingredient Reg. No. 57–55–6) is known as 1,2- different from the uses established in propanediol. It does not occur in na- this section do not exist or have been ture. Propylene glycol is manufactured waived. by treating propylene with chlorinated [47 FR 27812, June 25, 1982] water to form the chlorohydrin which is converted to the glycol by treatment § 184.1670 Propylparaben. with sodium carbonate solution. It is (a) Propylparaben is the chemical also prepared by heating glyercol with propyl p-hydroxybenzoate. It is pro- sodium hydroxide. duced by the n-propanol esterification (b) The ingredient meets the speci- of p-hydroxybenzoic acid in the pres- fications of the Food Chemicals Codex, ence of sulfuric acid, with subsequent 3d Ed. (1981), p. 255, which is incor- distillation. porated by reference. Copies may be (b) The ingredient meets the speci- obtained from the National Academy fications of the ‘‘Food Chemicals Press, 2101 Constitution Ave. NW., Codex,’’ 3d Ed. (1981), p. 258, which is in- Washington, DC 20418. It is also avail- corporated by reference. Copies may be able for inspection at the Office of the obtained from the National Academy Federal Register, 800 North Capitol Press, 2101 Constitution Ave. NW., Street, NW., suite 700, Washington, DC Washington, DC 20418, or may be exam- 20408. ined at the Office of the Federal Reg- (c) The ingredient is used as an ister, 800 North Capitol Street, NW., anticaking agent as defined in suite 700, Washington, DC 20408. § 170.3(o)(1) of this chapter; antioxidant (c) The ingredient is used as an anti- as defined in § 170.3(o)(3) of this chap- microbial agent as defined in ter; dough strengthener as defined in § 170.3(o)(2) of this chapter. § 170.3(o)(6) of this chapter; emulsifier (d) The ingredient is used in food at as defined in § 170.3(o)(8) of this chap- levels not to exceed good manufac- ter; flavor agent as defined in turing practices. Current good manu- § 170.3(o)(12) of this chapter; formula- facturing practice results in a max- tion aid as defined in § 170.3(o)(14) of imum level of 0.1 percent in food. this chapter; humectant as defined in (e) Prior sanctions for this ingredient § 170.3(o)(16) of this chapter; processing different from the uses established in aid as defined in § 170.3(o)(24) of this this regulation do not exist or have chapter; solvent and vehicle as defined been waived. in § 170.3(o)(27) of this chapter; stabilizer and thickener as defined in [42 FR 14653, Mar. 15, 1977, as amended at 49 § 170.3(o)(28) of this chapter; surface-ac- FR 5613, Feb. 14, 1984] tive agent as defined in § 170.3(o)(29) of this chapter; and texturizer as defined § 184.1676 Pyridoxine hydrochloride. in § 170.3(o)(32) of this chapter. (a) Pyridoxine hydrochloride (d) The ingredient is used in foods at (C8H11NO3·HCl, CAS Reg. No. 58–56–0) is levels not to exceed current good man- the chemical 3-hydroxy–4,5-

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dihydroxymethy–2-methylpyridine hy- tive enzyme rennin (CAS Reg. No. 9001– drochloride that is prepared by chem- 98–3), also known as chymosin (Inter- ical synthesis. national Union of Biochemistry En- (b) The ingredient meets the speci- zyme Commission (E.C.) 3.4.23.4). fications of the Food Chemicals Codex, Rennet is the aqueous extract prepared 3d Ed. (1981), p. 260, which is incor- from cleaned, frozen, salted, or dried porated by reference. Copies are avail- fourth stomachs (abomasa) of calves, able from the National Academy Press, kids, or lambs. Bovine rennet is the 2101 Constitution Ave. NW., Wash- product from adults of the animals list- ington, DC 20418, or available for ined above. Both products are called spection at the Office of the Federal rennet and are clear amber to dark Register, 800 North Capitol Street, brown liquid preparations or white to NW., suite 700, Washington, DC 20408. (c) In accordance with § 184.1(b)(1), tan powders. the ingredient is used in food with no (2) Chymosin preparation is a clear limitation other than current good solution containing the active enzyme manufacturing practice. The affirma- chymosin (E.C. 3.4.23.4). It is derived, tion of this ingredient as generally rec- via fermentation, from a nonpatho- ognized as safe (GRAS) as a direct genic and nontoxigenic strain of Esch- human food ingredient is based upon erichia coli K–12 containing the the following current good manufac- prochymosin gene. The prochymosin is turing practice conditions of use: isolated as an insoluble aggregate that (1) The ingredient is used as a nutri- is acid-treated to destroy residual cel- ent supplement as defined in lular material and, after solubilization, § 170.3(o)(20) of this chapter. is acid-treated to form chymosin. It (2) The ingredient is used in the fol- must be processed with materials that lowing foods at levels not to exceed are generally recognized as safe, or are current good manufacturing practice: food additives that have been approved baked goods as defined in § 170.3(n)(1) of by the Food and Drug Administration this chapter; nonalcoholic beverages for this use. and beverage bases as defined in (3) Chymosin preparation is a clear § 170.3(n)(3) of this chapter; breakfast solution containing the active enzyme cereals as defined in § 170.3(n)(4) of this chymosin (E.C. 3.4.23.4). It is derived, chapter; dairy product analogs as de- via fermentation, from a nonpatho- fined in § 170.3(n)(10) of this chapter; genic and nontoxigenic strain of meat products as defined in Kluyveromyces marxianus variety lactis, § 170.3(n)(29) of this chapter; milk prod- containing the prochymosin gene. The ucts as defined in § 170.3(n)(31) of this chapter; plant protein products as de- prochymosin is secreted by cells into fined in § 170.3(n)(33) of this chapter; fermentation broth and converted to and snack foods as defined in chymosin by acid treatment. All mate- § 170.3(n)(37) of this chapter. Pyridoxine rials used in the processing and formu- hydrochloride may be used in infant lating of chymosin must be either gen- formula in accordance with section erally recognized as safe (GRAS), or be 412(g) of the Federal Food, Drug, and food additives that have been approved Cosmetic Act (the Act) or with regula- by the Food and Drug Administration tions promulgated under section for this use. 412(a)(2) of the Act. (4) Chymosin preparation is a clear (d) Prior sanctions for this ingredient solution containing the active enzyme different from the uses established in chymosin (E.C. 3.4.23.4). It is derived, this section do not exist or have been via fermentation, from a nonpatho- waived. genic and nontoxigenic strain of Asper- [48 FR 51615, Nov. 10, 1983] gillus niger van Tieghem variety awamori (Nakazawa) Al-Musallam (syn- § 184.1685 Rennet (animal-derived) onym A. awamori Nakazawa) con- and chymosin preparation (fer- taining the prochymosin gene. mentation-derived). Chymosin is recovered from the fer- (a)(1) Rennet and bovine rennet are mentation broth after acid treatment. commercial extracts containing the ac- All materials used in the processing

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and formulating of chymosin prepara- organism Eremothecium ashbyii, or iso- tion must be either generally recog- lated from natural sources. nized as safe (GRAS) or be food addi- (b) The ingredient meets the speci- tives that have been approved by the fications of the Food Chemicals Codex, Food and Drug Administration for this 3d Ed. (1981), p. 262, which is incor- use. porated by reference. Copies are avail- (b) Rennet and chymosin preparation able from the National Academy Press, meet the general and additional re- 2101 Constitution Ave. NW., Wash- quirements for enzyme preparations of ington, DC 20418, or available for in- the ‘‘Food Chemicals Codex,’’ 3d Ed. spection at the Office of the Federal (1981), pp. 107–110, which is incorporated Register, 800 North Capitol Street, by reference in accordance with 5 NW., suite 700, Washington, DC 20408. U.S.C. 552(a). Copies are available from (c) In accordance with § 184.1(b)(1), the National Academy Press, 2101 Con- the ingredient is used in food with no stitution Avenue NW., Washington, DC limitation other than current good 20418, or are available for inspection at manufacturing practice. The affirma- the Office of the Federal Register, 800 tion of this ingredient as generally rec- North Capitol Street, NW., suite 700, ognized as safe (GRAS) as a direct Washington, DC. human food ingredient is based upon (c) In accordance with § 184.1(b)(1), the following current good manufac- the ingredient is used in food with no turing practice conditions of use: limitation other than current good (1) The ingredient is used as a nutri- manufacturing practice. The affirma- ent supplement as defined in tion of this ingredient as generally rec- § 170.3(o)(20) of this chapter. ognized as safe as a direct human food (2) The ingredient is used in foods at ingredient is based upon the following levels not to exceed current good man- current good manufacturing practice ufacturing practice. The ingredient conditions of use: may also be used in infant formula in (1) The ingredient is used as an en- accordance with section 412(g) of the zyme as defined in § 170.3(o)(9) of this Federal Food, Drug, and Cosmetic Act chapter; a processing aid as defined in (the Act) or with regulations promul- § 170.3(o)(24) of this chapter; and a sta- gated under section 412(a)(2) of the Act. bilizer and thickener as defined in § 170.3(o)(28) of this chapter. (d) Prior sanctions for this ingredient (2) The ingredient is used in the fol- different from the uses established in lowing foods at levels not to exceed this section do not exist or have been current good manufacturing practice: waived. In cheeses as defined in § 170.3(n)(5) of [48 FR 51148, Nov. 7, 1983] this chapter; frozen dairy desserts and mixes as defined in § 170.3(n)(20) of this § 184.1697 Riboflavin–5′-phosphate (so- chapter; gelatins, puddings, and fillings dium). as defined in § 170.3(n)(22) of this chap- (a) Riboflavin-5′-phosphate (sodium) ter; and milk products as defined in (C17H20N4O9PNa·2H2O, CAS Reg. No 130– § 170.3(n)(31) of this chapter. 40–5) occurs as the dihydrate in yellow (d) Prior sanctions for this ingredient to orange-yellow crystals. It is pre- different from the uses established in pared by phosphorylation of riboflavin this section do not exist or have been with chlorophosphoric acid, waived. pyrophosphoric acid, metaphosphoric [55 FR 10935, Mar. 23, 1990, as amended at 57 acid, or pyrocatechol cyclic phosphate. FR 6479, Feb. 25, 1992; 58 FR 27202, May 7, (b) The ingredient meets the speci- 1993] fications of the Food Chemicals Codex, 3d Ed. (1981), p. 263, which is incor- § 184.1695 Riboflavin. porated by reference. Copies are avail- (a) Riboflavin (C17H20N4O6, CAS Reg. able from the National Academy Press, No. 83–88–5) occurs as yellow to orange- 2101 Constitution Ave. NW., Wash- yellow needles that are crystallized ington DC 20418, or available for inspec- from 2N acetic acid, alcohol, water, or tion at the Office of the Federal Reg- pyridine. It may be prepared by chem- ister, 800 North Capitol Street, NW., ical synthesis, biosynthetically by the suite 700, Washington, DC 20408.

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(c) In accordance with § 184.1(b)(1), (b) The ingredient is used in all cat- the ingredient is used in food with no egories of food in accordance with limitation other than current good § 184.1(b)(2) of this chapter at con- manufacturing practice. The affirma- centrations not to exceed 2 parts per tion of this ingredient as generally rec- million. ognized as safe (GRAS) as a direct (c) Prior sanctions for this ingredient human food ingredient is based upon different from the uses established in the following current good manufac- this section do not exist or have been turing practice conditions of use: waived. (1) The ingredient is used as a nutri- [43 FR 3705, Jan. 27, 1978] ent supplement as defined in § 170.3(o)(20) of this chapter. § 184.1699 Oil of rue. (2) The ingredient is used in milk products, as defined in § 170.3(n)(31) of (a) Oil of rue is the natural substance this chapter, at levels not to exceed obtained by steam distillation of the current good manufacturing practice. fresh blossoming plants of rue, the pe- The ingredient may also be used in in- rennial herb of several species of fant formulas in accordance with sec- Ruta—Ruta montana L., Ruta graveolens tion 412(g) of the Federal Food, Drug, L., Ruta bracteosa L., and Ruta and Cosmetic Act (the Act) or with reg- calepensis L. ulations promulgated under section (b) Oil of rue meets the specifications 412(a)(2) of the Act. of the ‘‘Food Chemicals Codex,’’ 4th ed. (d) Prior sanctions for this ingredient (1996), pp. 342–343, which is incorporated different from the uses established in by reference in accordance with 5 this section do not exist or have been U.S.C. 552(a) and 1 CFR part 51. Copies waived. are available from the National Acad- emy Press, Box 285, 2101 Constitution [48 FR 51148, Nov. 7, 1983] Ave. NW., Washington, DC 20055 (Inter- net address http://www.nap.edu), or § 184.1698 Rue. may be examined at the Center for (a) Rue is the perennial herb of sev- Food Safety and Applied Nutrition’s eral species of Ruta (Ruta montana L., Library, Food and Drug Administra- Ruta graveolens L., Ruta bracteosa L., tion, 5100 Paint Branch Pkwy., College and Ruta calepensis L.). The leaves, Park, MD 20740, or at the Office of the buds, and stems from the top of the Federal Register, 800 North Capitol St. plant are gathered, dried, and then NW., suite 700, Washington, DC. crushed in preparation for use, or left (c) The ingredient is used in food whole. under the following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Parts per Food (as served) million Function

Baked goods and baking mixes, § 170.3(n)(1), of 10 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter. this chapter. Frozen dairy desserts and mixes, § 170.3 (n)(20) of 10 Do. this chapter. Soft candy, § 170.3(n)(38) of this chapter ...... 10 Do. All other food categories ...... 4 Do.

(d) Prior sanctions for this ingredient § 184.1702 Sheanut oil. different from the uses established in (a) Sheanut oil is produced from this section do not exist or have been sheanuts derived from the Shea tree waived. Butyrospermum parkii and is composed [42 FR 14653, Mar. 15, 1977, as amended at 49 principally of triglycerides containing FR 5613, Feb. 14, 1984; 64 FR 1760, Jan. 12, an oleic acid moiety at the 2-position 1999] and saturated fatty acids, usually stearic or palmitic acids, at the 1- and 3- positions.

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(b) The ingredient meets the fol- § 170.3(o)(12) of this chapter; and as a pH lowing specifications when tested using control agent as defined in § 170.3(o)(23) any appropriate validated method- of this chapter. ology: (d) The ingredient is used in food at (1) Saponification value of 185 to 195, levels not to exceed current good man- (2) Iodine value of 28 to 43, ufacturing practice in accordance with (3) Unsaponifiable matter not to ex- 184.1(b)(1). Current good manufacturing ceed 1.5 percent, practice results in a maximum level, as (4) Free fatty acids not more than 0.1 served, of 0.007 percent for breakfast percent as oleic acid, cereals as defined in § 170.3(n)(4) of this (5) Peroxide value not more than 10 chapter; 0.5 percent for fats and oils as milliequivalents/equivalent (meq/eq), defined in § 170.3(n)(12) of this chapter; (6) Lead not more than 0.1 part per 0.6 percent for grain products and pas- million (ppm), tas as defined in § 170.3(n)(23) of this (7) Copper not more than 0.1 ppm. chapter and snack foods as defined in (c) In accordance with § 184.1(b)(3), § 170.3(n)(37) of this chapter; 0.15 per- the ingredient is used in the following cent for hard candy as defined in food categories at levels not to exceed § 170.3(n)(25) of this chapter; 0.12 per- current good manufacturing practice, cent for jams and jellies as defined in except that the ingredient may not be § 170.3(n)(28) of this chapter and meat used in a standardized food unless per- products as defined in § 170.3(n)(29) of mitted by the standard of identity: this chapter; 0.2 percent for soft candy Confections and frostings as defined in as defined in § 170.3(n)(38) of this chap- § 170.3(n)(9) of this chapter, coatings of ter; 0.05 percent for soups and soup soft candy as defined in § 170.3(n)(38) of mixes as defined in § 170.3(n)(40) of this this chapter, and sweet sauces and top- chapter and sweet sauces as defined in pings as defined in § 170.3(n)(43) of this § 170.3(n)(43) of this chapter. chapter. (e) Prior sanctions for this ingredient different from the uses established in [63 FR 28895, May 27, 1998] this section do not exist or have been § 184.1721 Sodium acetate. waived.

(a) Sodium acetate (C2H3O2Na, CAS [47 FR 27815, June 25, 1982] Reg. No. 127–09–3 or C2H3O2Na·3H2O, CAS Reg. No. 6131–90–4) is the sodium § 184.1724 Sodium alginate. salt of acetic acid and occurs naturally (a) Sodium alginate (CAS Reg. No. in plant and animal tissues. Sodium ac- 9005–38–3) is the sodium salt of alginic etate may occur in either the anhy- acid, a natural polyuronide constituent drous or trihydrated form. It is proof certain brown algae. Sodium algi- duced synthetically by the neutraliza- nate is prepared by the neutralization tion of acetic acid with sodium car- of purified alginic acid with appro- bonate or by treating calcium acetate priate pH control agents. with sodium sulfate and sodium bicar- (b) The ingredient meets the speci- bonate. fications of the Food Chemicals Codex, (b) The ingredient meets the speci- 3d Ed. (1981), p. 274, which is incor- fications of the Food Chemicals Codex, porated by reference. Copies are avail- 3d Ed. (1981), pp. 272, 273 which is incor- able from the National Academy Press, porated by reference. Copies are avail- 2101 Constitution Ave. NW., Wash- able from the National Academy Press, ington, DC 20418, or available for in- 2101 Constitution Ave. NW., Wash- spection at the Office of the Federal ington, DC 20418, or available for in- Register, 800 North Capitol Street, spection at the Office of the Federal NW., suite 700, Washington, DC 20408. Register, 800 North Capitol Street, (c) In accordance with § 184.1(b)(2), NW., suite 700, Washington, DC 20408. the ingredient is used in food only (c) The ingredient is used as a fla- within the following specific limita- voring agent and adjuvant as defined in tions:

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Maximum level of Category of food use in food Functional use (as served) (percent)

Condiments and relishes, § 170.3(n)(8) of this chapter, 1.0 Texturizer, § 170.3(o)(32) of this chapter, formulation aid except pimento ribbon for stuffed olives. § 170.3(o)(14) of this chapter, stabilizer, thickener, § 170.3(o)(28) of this chapter. Pimento ribbon for stuffed olives ...... 6.0 Do. Confections and frostings, § 170.3(n)(9) of this chapter .. 0.3 Stabilizer, thickener, § 170.3(o)(28) of this chapter. Gelatins and puddings, § 170.3(n)(22) of this chapter ..... 4.0 Firming agent, § 170.3(o)(10) of this chapter; flavor adjuvant, § 170.3(o)(12) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter. Hard candy, § 170.3(n)(25) of this chapter ...... 10.0 Stabilizer, thickener, § 170.3(o)(28) of this chapter. Processed fruits and fruit juices, § 170.3(n)(35) of this 2.0 Formulation aid, §170.3(o)(14) of this chapter; chapter. texturizer, § 170.3(o)(32) of this chapter. All other food categories ...... 1.0 Emulsifier, § 170.3(o)(8) of this chapter; firming agent, § 170.3(o)(10) of this chapter; flavor enhancer, § 170.3(o)(11) of this chapter; flavor adjuvant, § 170.3(o)(12) of this chapter; processing aid, § 170.3(o)(24) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter; surface active agent, § 170.3(o)(29) of this chapter.

(d) Prior sanctions for sodium algi- (e) Prior sanctions for this ingredient nate different from the uses established different from the uses established in in this section do not exist or have this section, or different from that set been waived. forth in part 181 of this chapter, do not exist or have been waived. [47 FR 29951, July 9, 1982, as amended at 48 FR 52448, Nov. 18, 1983] [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984] § 184.1733 Sodium benzoate. § 184.1736 Sodium bicarbonate. (a) Sodium benzoate is the chemical benzoate of soda (C7H5NaO2), produced (a) Sodium bicarbonate (NaHCO3, by the neutralization of benzoic acid CAS Reg. No. 144–55–8) is prepared by with sodium bicarbonate, sodium car- treating a sodium carbonate or a so- bonate, or sodium hydroxide. The salt dium carbonate and sodium bicarbon- is not found to occur naturally. ate solution with carbon dioxide. As (b) The ingredient meets the speci- carbon dioxide is absorbed, a suspen- fications of the ‘‘Food Chemicals sion of sodium bicarbonate forms. The Codex,’’ 3d Ed. (1981), p. 278, which is in- slurry is filtered, forming a cake which corporated by reference. Copies may be is washed and dried. obtained from the National Academy (b) The ingredient meets the speci- Press, 2101 Constitution Ave. NW., fications of the Food Chemicals Codex, Washington, DC 20418, or may be exam- 3d Ed. (1981), p. 278, which is incor- ined at the Office of the Federal Reg- porated by reference. Copies are avail- ister, 800 North Capitol Street, NW., able from the National Academy Press, suite 700, Washington, DC 20408. 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- (c) The ingredient is used as an anti- spection at the Office of the Federal microbial agent as defined in Register, 800 North Capitol Street, § 170.3(o)(2) of this chapter, and as a fla- NW., suite 700, Washington, DC 20408. voring agent and adjuvant as defined in (c) In accordance with § 184.1(b)(1), § 170.3(o)(12) of this chapter. the ingredient is used in food with no (d) The ingredient is used in food at limitation other than current good levels not to exceed good manufac- manufacturing practice. turing practice. Current usage results (d) Prior sanctions for this ingredient in a maximum level of 0.1 percent in different from the uses established in food. (The Food and Drug Administra- this section do not exist or have been tion has not determined whether waived. significally different conditions of use would be GRAS.) [48 FR 52442, Nov. 18, 1983]

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§ 184.1742 Sodium carbonate. (b) The ingredient meets the specifications of the Food Chemicals Codex, (a) Sodium carbonate (Na CO , CAS 2 3 3d ed. (1981), pp. 283–284, which is incor- Reg. No. 497–19–8) is produced (1) from porated by reference in accordance purified trona ore that has been with 5 U.S.C. 552(a) and 1 CFR part 51. calcined to soda ash; (2) from trona ore Copies are available from the National calcined to impure soda ash and then Academy Press, 2101 Constitution Ave. purified; or (3) synthesized from lime- NW., Washington, DC 20418, and the stone by the Solvay process. Center for Food Safety and Applied Nu- (b) The ingredient meets the speci- trition (HFS–200), 5100 Paint Branch fications of the Food Chemicals Codex, Pkwy., College Park, MD 20740, or may 3d Ed. (1981), p. 280, which is incor- be examined at the Office of the Fed- porated by reference. Copies are avail- eral Register, 800 North Capitol St. able from the National Academy Press, NW., suite 700, Washington, DC. 2101 Constitution Ave. NW., Wash- (c) In accordance with § 184.1(b)(1), ington, DC 20418, or available for in- the ingredient is used in food with no spection at the Office of the Federal limitation other than current good Register, 800 North Capitol Street, manufacturing practice. NW., suite 700, Washington, DC 20408. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the uses established in the ingredient is used in food with no this section, or different from those set limitation other than current good forth in part 181 of this chapter, do not manufacturing practice. The affirma- exist or have been waived. tion of this ingredient as generally recognized as safe (GRAS) as a direct [59 FR 63896, Dec. 12, 1994] human food ingredient is based upon § 184.1754 Sodium diacetate. the following current good manufacturing practice conditions of use: (a) Sodium diacetate (C4H7O4Na·xH2O, (1) The ingredient is used in food as CAS Reg. No. 126–96–5) is a molecular an antioxidant as defined in § 170.3(o)(3) compound of acetic acid, sodium ace- of this chapter; curing and pickling tate, and water of hydration. The tech- agent as defined in § 170.3(o)(5) of this nical grade is prepared synthetically chapter; flavoring agent and adjuvant by reacting sodium carbonate with ace- as defined in § 170.3(o)(12) of this chap- tic acid. Special grades are produced by ter; pH control agent as defined in reacting anhydrous sodium acetate and § 170.3(o)(23) of this chapter; and proc- acetic acid. essing aid as defined in § 170.3(o)(24) of (b) The ingredient meets the speci- this chapter. fications of the Food Chemicals Codex, (2) The ingredient is used in food at 3d Ed. (1981), p. 284, which is incor- levels not to exceed current good man- porated by reference. Copies are available from the National Academy Press, ufacturing practice. 2101 Constitution Ave. NW., Wash- (d) Prior sanctions for this ingredient ington, DC 20418, or available for in- different from the uses established in spection at the Office of the Federal this section do not exist or have been Register, 800 North Capitol Street, waived. NW., suite 700, Washington, DC 20408. [48 FR 52442, Nov. 18, 1983, as amended at 50 (c) The ingredient is used as an anti- FR 49536, Dec. 3, 1985] microbial agent as defined in § 170.3(o)(2) of this chapter; flavoring § 184.1751 Sodium citrate. agent and adjuvant as defined in (a) Sodium citrate (C6H5Na3O7·2H2O, § 170.3(o)(12) of this chapter; and pH CAS Reg. No. 68–0904–092) is the sodium control agent as defined in § 170.3(o)(23) salt of citric acid. It is prepared by of this chapter. neutralizing citric acid with sodium (d) The ingredient is used in food at hydroxide or sodium carbonate. The levels not to exceed current good man- product occurs as colorless crystals or ufacturing practice in accordance with a white crystalline powder. It may be § 184.1(b)(1). Current good manufac- prepared in an anhydrous state or may turing practice results in a maximum contain two moles of water per mole of level, as served, 0.4 percent for baked sodium citrate. goods as defined in § 170.3(n)(1) of this

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chapter; 0.1 percent for fats and oils as this section do not exist or have been defined in § 170.3(n)(12) of this chapter, waived. meat products as defined in [48 FR 52444, Nov. 18, 1983] § 170.3(n)(29) of this chapter and soft candy as defined in § 170.3(n)(38) of this § 184.1764 Sodium hypophosphite. chapter; 0.25 percent for gravies and (a) Sodium hypophosphite (NaH2PO2, sauces as defined in § 170.3(n)(24) of this CAS Reg. No. 7681–53–0) is a white, chapter; and 0.05 percent for snack odorless, deliquescent granular powder foods as defined in § 170.3(n)(37) of this with a saline taste. It is also prepared chapter and soups and soup mixes as as colorless, pearly crystalline plates. defined in § 170.3(n)(40) of this chapter. It is soluble in water, alcohol, and (e) Prior sanctions for this ingredient glycerol. It is prepared by neutraliza- different from the uses established in tion of hypophosphorous acid or by di- this section do not exist or have been rect aqueous alkaline hydrolysis of waived. white phosphorus. (b) FDA is developing food-grade [47 FR 27815, June 25, 1982] specifications for sodium hypophosphite in cooperation with the § 184.1763 Sodium hydroxide. National Academy of Sciences. In the (a) Sodium hydroxide (NaOH, CAS interim, the ingredient must be of a Reg. No. 1310–73–2) is also known as so- suitable purity for its intended use. dium hydrate, soda lye, caustic soda, (c) In accordance with § 184.1(b)(1), white caustic, and lye. The empirical the ingredient is used in food with no formula is NaOH. Sodium hydroxide is limitations other than current good prepared commercially by the elec- manufacturing practice. The affirma- trolysis of sodium chloride solution tion of this ingredient as generally rec- and also by reacting calcium hydroxide ognized as safe (GRAS) as a direct with sodium carbonate. human food ingredient is based upon (b) The ingredient meets the speci- the following current good manufac- fications of the Food Chemicals Codex, turing practice conditions of use: 3d Ed. (1981), which is incorporated by (1) The ingredient is used as an emulsifier or stabilizer, as defined in reference. Copies are available from §§ 170.3(o)(8) and 170.3(o)(28) of this the National Academy Press, 2101 Con- chapter. stitution Ave. NW., Washington, DC (2) The ingredient is used in cod-liver 20418, or available for inspection at the oil emulsions at levels not to exceed Office of the Federal Register, 800 current good manufacturing practice. North Capitol Street, NW., suite 700, (d) Prior sanctions for this ingredient Washington, DC 20408. different from the use established in (c) In accordance with § 184.1(b)(1), this section do not exist or have been the ingredient is used in food with no waived. limitation other than current good manufacturing practice. The affirma- [47 FR 38277, Aug. 31, 1982] tion of this ingredient as generally rec- § 184.1768 Sodium lactate. ognized as safe (GRAS) as a direct human food ingredient is based upon (a) Sodium lactate (C3H5O3Na, CAS Reg. No. 72–17–3) is the sodium salt of the following current good manufac- lactic acid. It is prepared commercially turing practice conditions of use: by the neutralization of lactic acid (1) The ingredient is used as a pH with sodium hydroxide. control agent as defined in § 170.3(o)(23) (b) FDA is developing food-grade of this chapter and as a processing aid specifications for sodium lactate in co- as defined in § 170.3(o)(24) of this chap- operation with the National Academy ter. of Sciences. In the interim, this ingre- (2) The ingredient is used in foods at dient must be of a purity suitable for levels not to exceed current good man- its intended use. ufacturing practice. (c) In accordance with § 184.1(b)(1), (d) Prior sanctions for this ingredient the ingredient is used in food with no different from the uses established in limitation other than current good

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manufacturing practice. This regula- fruits, vegetables, and nuts when used tion does not authorize its use in in- in accordance with § 173.315 of this fant foods and infant formulas. The af- chapter; for use as a denuding agent in firmation of this ingredient as gen- tripe; for use as a hog scald agent in re- erally recognized as safe (GRAS) as a moving hair; and for use as a corrosion direct human food ingredient is based preventative in canned and bottled upon the following current good manu- water when used in accordance with facturing practice conditions of use: § 103.35 of this chapter. (1) The ingredient is used as an emul- (d) Prior sanctions for this ingredient sifier as defined in § 170.3(o)(8) of this different from the uses established in chapter; a flavor enhancer as defined in this section do not exist or have been § 170.3(o)(11) of this chapter; a flavoring waived. agent or adjuvant as defined in § 170.3(o)(12) of this chapter; a humec- [50 FR 38781, Sept. 25, 1985; 50 FR 42011, Oct. tant as defined in § 170.3(o)(16) of this 17, 1985] chapter; and a pH control agent as defined in § 170.3(o)(23) of this chapter. § 184.1784 Sodium propionate. (2) The ingredient is used in food at (a) Sodium propionate (C3H5NaO2, levels not to exceed current good man- CAS Reg. No. 137–40–6) is the sodium ufacturing practice. salt of propionic acid. It occurs as (d) Prior sanctions for this ingredient colorless, transparent crystals or a different from the uses established in granular crystalline powder. It is odor- this section do not exist or have been less, or has a faint acetic-butyric acid waived. odor, and is deliquescent. It is prepared [52 FR 10886, Apr. 6, 1987] by neutralizing propionic acid with sodium hydroxide. § 184.1769a Sodium metasilicate. (b) The ingredients meets the speci- (a) Sodium metasilicate (CAS Reg. fications of the Food Chemicals Codex, No. 6834–92–0) is a strongly alkaline 3d Ed. (1981), p. 296, which is incor- white powder. It does not occur natu- porated by reference. Copies are avail- rally but rather is synthesized by melt- able from the the National Academy ing sand with sodium carbonate at 1400 Press, 2101 Constitution Ave. NW., °C. The commercially available forms Washington DC 20418, or available for of sodium metasilicate are the anhy- inspection at the Office of the Federal drous form (Na SiO ), the pentahydrate Register, 800 North Capitol Street, 2 3 NW., suite 700, Washington, DC 20408. (Na2SiO3·5H2O), and the nonahydrate (c) In accordance with § 184.1(b)(1), (Na2SiO3·9H2O). (b) FDA is developing food-grade the ingredient is used in food with no specifications for sodium metasilicate limitation other than current good in cooperation with the National Acad- manufacturing practice. The affirma- emy of Sciences. In the interim, the in- tion of this ingredient as generally rec- gredient must be of a purity suitable ognized as safe (GRAS) as a direct for its intended use. human food ingredient is based upon (c) In accordance with § 184.1(b)(1), the following current good manufac- the ingredient is used in food with no turing practice conditions of use: limitation other than current good (1) The ingredient is used as an anti- manufacturing practice. The affirma- microbial agent as defined in tion of this ingredient as generally rec- § 170.3(o)(2) of this chapter and a fla- ognized as safe (GRAS) as a direct voring agent as defined in § 170.3(o)(12) human food ingredient is based upon of this chapter. the following current good manufac- (2) The ingredient is used in the fol- turing practice conditions of use: lowing foods at levels not to exceed (1) The ingredient is used as a proc- current good manufacturing practice: essing aid as defined in § 170.3(o)(24) of baked goods as defined in § 170.3(n)(1) of this chapter. this chapter; nonalcoholic beverages as (2) The ingredient is used to treat the defined in § 170.3(n)(3) of this chapter; following foods at levels not to exceed cheeses as defined in § 170.3(n)(5) of this current good manufacturing practice: chapter; confections and frostings as for use in washing and lye peeling of defined in § 170.3(n)(9) of this chapter;

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gelatins, puddings, and fillings as de- § 184.1801 Sodium tartrate. fined in § 170.3(n)(22) of this chapter; (a) Sodium tartrate (C H Na O ·2H O, jams and jellies as defined in 4 4 2 6 2 CAS Reg. No. 868–18–8) is the disodium § 170.3(n)(28) of this chapter; meat prod- salt of L¥(+)¥tartaric acid. It occurs ucts as defined in § 170.3(n)(29) of this as transparent, colorless, and odorless chapter; and soft candy as defined in crystals. It is obtained as a byproduct § 170.3(n)(38) of this chapter. of wine manufacture. (d) Prior sanctions for this ingredient (b) The ingredient meets the speci- different from the uses established in fications of the Food Chemicals Codex, this section do not exist or have been 3d Ed. (1981), p. 303, which is incor- waived. porated by reference. Copies are avail- [49 FR 13142, Apr. 3, 1984] able from the National Academy Press, 2101 Constitution Ave. NW., Wash- § 184.1792 Sodium sesquicarbonate. ington, DC 20418, or available for in- (a) Sodium sesquicarbonate spection at the Office of the Federal Register, 800 North Capitol Street, (Na2CO3·NaHCO3·2H2O, CAS Reg. No. 533–96–0) is prepared by: (1) Partial NW., suite 700, Washington, DC 20408. carbonation of soda ash solution fol- (c) In accordance with § 184.1(b)(1), lowed by crystallization, centrifuga- the ingredient is used in food with no tion, and drying; (2) double refining of limitation other than current good trona ore, a naturally occurring im- manufacturing practice. The affirma- pure sodium sesquicarbonate. tion of this ingredient as generally rec- (b) The ingredient meets the speci- ognized as safe (GRAS) as a direct fications of the Food Chemicals Codex, human food ingredient is based upon 3d Ed. (1981), p. 299, which is incor- the following current good manufac- porated by reference. Copies are avail- turing practice conditions of use: able from the National Academy Press, (1) The ingredient is used as an emul- 2101 Constitution Ave. NW., Wash- sifier as defined in § 170.3(o)(8) of this ington, DC 20418, or available for in- chapter and as a pH control agent as spection at the Office of the Federal defined in § 170.3(o)(23) of this chapter. Register, 800 North Capitol Street, (2) The ingredient is used in the fol- NW., suite 700, Washington, DC 20408. lowing foods at levels not to exceed (c) In accordance with § 184.1(b)(1), current good manufacturing practice: the ingredient is used in food with no cheeses as defined in§ 170.3(n)(5) of this limitation other than current good chapter; fats and oils as defined in manufacturing practice. The affirma- § 170.3(n)(12) of this chapter; and jams tion of this ingredient as generally rec- and jellies as defined in § 170.3(n)(28) of ognized as safe (GRAS) as a direct this chapter. human food ingredient is based upon (d) Prior sanctions for this ingredient the following current good manufac- different from the uses established in turing practice conditions of use: this section do not exist or have been (1) The ingredient is used as a pH waived. control agent as defined in § 170.3(o)(23) [48 FR 52447, Nov. 18, 1983] of this chapter. (2) The ingredient is used in cream at § 184.1804 Sodium potassium tartrate. levels not to exceed current good man- (a) Sodium potassium tartrate ufacturing practice. Current good man- (C H KNaO ·4H O, CAS Reg. No. 304–59– ufacturing practice utilizes a level of 4 4 6 2 6) is the sodium potassium salt of the ingredient sufficient to control lac- L¥(+)¥tartaric acid and is also called tic acid prior to pasteurization and the Rochelle salt. It occurs as colorless churning of cream into butter. crystals or as a white, crystalline pow- (d) Prior sanctions for this ingredient der and has a cooling saline taste. It is different from the uses established in obtained as a byproduct of wine manu- this section do not exist or have been facture. waived. (b) The ingredient meets the speci- [48 FR 52443, Nov. 18, 1983] fications of the Food Chemicals Codex,

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3d Ed. (1981), p. 296, which is incor- to exceed good manufacturing practice. porated by reference. Copies are avail- Current good manufacturing practice able from the National Academy Press, results in a maximum level, as served, 2101 Constitution Ave. NW., Wash- of 0.00005 percent for alcoholic bev- ington, DC 20418, or available for in- erages as defined in § 170.3(n)(2) of this spection at the Office of the Federal chapter and 0.1 percent for table salt as Register, 800 North Capitol Street, defined in § 170.3(n)(26) of this chapter. NW., suite 700, Washington, DC 20408. (e) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the uses established in the ingredient is used in food with no this section do not exist or have been limitation other than current good waived. manufacturing practice. The affirma- [43 FR 22938, May 30, 1978, as amended at 49 tion of this ingredient as generally rec- FR 5613, Feb. 4, 1984] ognized as safe (GRAS) as a direct human food ingredient is based upon § 184.1835 Sorbitol. the following current good manufac- (a) Sorbitol is the chemical 1,2,3,4,5,6- turing practice conditions of use: hexanehexol (C6H14O6), a hexahydric al- (1) The ingredient is used as an emul- cohol, differing from mannitol prin- sifier as defined in § 170.3(o)(8) of this cipally by having a different optical ro- chapter and as a pH control agent as tation. Sorbitol is produced by the defined in § 170.3(o)(23) of this chapter. electrolytic reduction, or the transi- (2) The ingredient is used in the fol- tion metal catalytic hydrogenation of lowing foods at levels not to exceed sugar solutions containing glucose or current good manufacturing practice: fructose. cheeses as defined in § 170.3(n)(5) of this (b) The ingredient meets the speci- chapter and jams and jellies as defined fications of the ‘‘Food Chemicals in § 170.3(n)(28) of this chapter. Codex,’’ 3d Ed. (1981), p. 308, which is in- (d) Prior sanctions for this ingredient corporated by reference. Copies may be different from the uses established in obtained from the National Academy this section do not exist or have been Press, 2101 Constitution Ave. NW., waived. Washington, DC 20418, or may be exam- [48 FR 52447, Nov. 18, 1983] ined at the Office of the Federal Reg- ister, 800 North Capitol Street, NW., § 184.1807 Sodium thiosulfate. suite 700, Washington, DC 20408.

(a) Sodium thiosulfate (Na2S2O3·5H2O, (c) The ingredient is used as an CAS Reg. No. 010102–0917–097) is also anticaking agent and free-flow agent as known as sodium hyposulfite. It is pre- defined in § 170.3(o)(1) of this chapter, pared synthetically by the reaction of curing and pickling agent as defined in sulfides and sulfur dioxide (SO2), the § 170.3(o)(5) of this chapter, drying reaction of sulfur and sulfite, or the ox- agent as defined in § 170.3(o)(7) of this idation of metal sulfides and chapter, emulsifier and emulsifier salt hydrosulfides. as defined in § 170.3(o)(8) of this chap- (b) The ingredient meets the speci- ter, firming agent as defined in fications of the ‘‘Food Chemicals § 170.3(o)(10) of this chapter, flavoring Codex,’’ 3d Ed. (1981), p. 304, which is in- agent and adjuvant as defined in corporated by reference. Copies may be § 170.3(o)(12) of this chapter, formula- obtained from the National Academy tion aid as defined in § 170.3(o)(14) of Press, 2101 Constitution Ave. NW., this chapter, humectant as defined in Washington, DC 20418, or may be exam- § 170.3(o)(16) of this chapter, lubricant ined at the Office of the Federal Reg- and release agent as defined in ister, 800 North Capitol Street, NW., § 170.3(o)(18) of this chapter, nutritive suite 700, Washington, DC 20408. sweetener as defined in § 170.3(o)(21) of (c) The ingredient is used as a formu- this chapter, sequestrant as defined in lation aid as defined in § 170.3(o)(14) of § 170.3(o)(26) of this chapter, stabilizer this chapter and reducing agent as de- and thickener as defined in § 170.3(o)(28) fined in § 170.3(o)(22) of this chapter. of this chapter, surface-finishing agent (d) The ingredient is used in alco- as defined in § 170.3(o)(30) of this chap- holic beverages and table salt in ac- ter, and texturizer as defined in cordance with § 184.1(b)(1) at levels not § 170.3(o)(32) of this chapter.

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(d) The ingredient is used in food at (c) The ingredient is used as an anti- levels not to exceed good manufac- oxidant as defined in § 170.3(o)(3) of this turing practices. Current good manu- chapter. facturing practice in the use of sorbitol (d) The ingredient is used in food at results in a maximum level of 99 per- levels not to exceed current good man- cent in hard candy and cough drops as ufacturing practice in accordance with defined in § 170.3(n)(25) of this chapter, § 184.(b)(1). Current good manufacturing 75 percent in chewing gum as defined in practice results in a maximum level, as § 170.3(n)(6) of this chapter, 98 percent served, of 0.0015 percent or less; cal- in soft candy as defined in § 170.3(n)(38) culated as tin, for all food categories. of this chapter, 30 percent in non- (e) Prior sanctions for this ingredient standardized jams and jellies, commer- different from those uses established in cial, as defined in § 170.3(n)(28) of this this section do not exist or have been chapter, 30 percent in baked goods and waived. baking mixes as defined in § 170.3(n)(1) [47 FR 27816, June 25, 1982] of this chapter, 17 percent in frozen dairy desserts and mixes as defined in § 184.1848 Starter distillate. § 170.3(n)(20) of this chapter, and 12 percent in all other foods. (a) Starter distillate (butter starter (e) The label and labeling of food distillate) is a steam distillate of the whose reasonably foreseeable consump- culture of any or all of the following tion may result in a daily ingestion of species of bacteria grown on a medium 50 grams of sorbitol shall bear the consisting of skim milk usually for- statement: ‘‘Excess consumption may tified with about 0.1 percent citric acid: have a laxative effect.’’ Streptococcus lactis, S. cremoris, S. lactis subsp. diacetylactis, Leuconostoc (f) Prior sanctions for this ingredient citrovorum, and L. dextranicum. The in- different from the uses established in gredient contains more than 98 percent this regulation do not exist or have water, and the remainder is a mixture been waived. of butterlike flavor compounds. Diace- [42 FR 14653, Mar. 15, 1977, as amended at 49 tyl is the major flavor component, con- FR 5613, Feb. 14, 1984] stituting as much as 80 to 90 percent of the mixture of organic flavor com- § 184.1845 Stannous chloride (anhy- pounds. Besides diacetyl, starter dis- drous and dihydrated). tillate contains minor amounts of acet- (a) Stannous chloride is anhydrous or aldehyde, ethyl formate, ethyl acetate, contains two molecules of water of hy- acetone, ethyl alcohol, 2-butanone, dration. Anhydrous stannous chloride acetic acid, and acetoin. (SnCl2, CAS Reg. No. 7772–99–8) is the (b) FDA is developing food-grade chloride salt of metallic tin. It is pre- specifications for starter distillate in pared by reacting molten tin with ei- cooperation with the National Acad- ther chlorine or gaseous tin tetra- emy of Sciences. In the interim, this chloride. Dihydrated stannous chloride ingredient must be of a purity suitable (SnCl2·2H2O, CAS Reg. No. 10025–0969– for its intended use. 091) is the chloride salt of metallic tin (c) In accordance with § 184.1(b)(1), that contains two molecules of water. the ingredient is used in food with no It is prepared from granulated tin sus- limitation other than current good pended in water and hydrochloric acid manufacturing practice. The affirma- or chlorine. tion of this ingredient as generally rec- (b) Both forms of the ingredient meet ognized as safe (GRAS) as a direct the specifications of the Food Chemi- human food ingredient is based upon cals Codex, 3d Ed. (1981), p. 312, which is the following current good manufac- incorporated by reference. Copies are turing practice conditions of use: available from the National Academy (1) The ingredient is used as a fla- Press, 2101 Constitution Ave. NW., voring agent and adjuvant as defined in Washington, DC 20418, or available for § 170.3(o)(12) of this chapter. inspection at the Office of the Federal (2) The ingredient is used in food at Register, 800 North Capitol Street, levels not to exceed current good man- NW., suite 700, Washington, DC 20408. ufacturing practice.

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(d) Prior sanctions for this ingredient diffusion, then clarified and evapo- different from the uses established in rated. this section do not exist or have been (b) FDA is developing food-grade waived. specifications for sucrose in cooperation with the National Academy of [48 FR 51907, Nov. 15, 1983] Sciences. In the interim, this ingre- § 184.1851 Stearyl citrate. dient must be of a purity suitable for its intended use. (a) Stearyl citrate is a mixture of the (c) In accordance with § 184.1(b)(1), mono-, di-, and tristearyl esters of cit- the ingredient is used in food with no ric acid. It is prepared by esterifying limitation other than current good citric acid with stearyl alcohol. manufacturing practice. (b) The Food and Drug Administra- (d) Prior sanctions for this ingredient tion, in cooperation with the National different from the uses established in Academy of Sciences, is developing this section do not exist or have been food-grade specifications for stearyl waived. citrate. In the interim, this ingredient must be of a purity suitable for its in- [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, tended use. 1989] (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no § 184.1857 Corn sugar. limitation other than current good (a) Corn sugar (C6H12O6, CAS Reg. No. manufacturing practice. The affirma- 50–99–7), commonly called D-glucose or tion of this ingredient as generally rec- dextrose, is the chemical a-D- ognized as safe (GRAS) as a direct glucopyranose. It occurs as the anhy- human food ingredient is based upon drous or the monohydrate form and is the following current good manufac- produced by the complete hydrolysis of turing practice conditions of use: corn starch with safe and suitable acids (1) The ingredient is used as an anti- or enzymes, followed by refinement and oxidant as defined in § 170.3(o)(3) of this crystallization from the resulting hy- chapter; an emulsifier and emulsifier drolysate. salt as defined in § 170.3(o)(8) of this (b) The ingredient meets the speci- chapter; a sequestrant as defined in fications of the Food Chemicals Codex, § 170.3(o)(26) of this chapter; and a sur- 3d Ed. (1981), pp. 97–98 under the head- face-active agent as defined in ing ‘‘Dextrose,’’ which is incorporated § 170.3(o)(29) of this chapter. by reference in accordance with 5 (2) The ingredient is used in mar- U.S.C. 552(a) and 1 CFR part 1. Copies garine in accordance with § 166.110 of are available from the National Acad- this chapter; in nonalcoholic beverages emy Press, 2101 Constitution Ave., NW., as defined in § 170.3(n)(3) of this chap- Washington, DC 20418, or available for ter; and in fats and oils as defined in inspection at the Office of the Federal § 170.3(n)(12) of this chapter at levels Register, 800 North Capitol Street, not to exceed current good manufac- NW., suite 700, Washington, DC 20408. turing practice. (c) In accordance with § 184.1(b)(1), (d) Prior sanctions for this ingredient the ingredient is used in food with no different from the uses established in limitation other than current good this section, or different from those set manufacturing practice. forth in part 181 of this chapter, do not (d) Prior sanctions for this ingredient exist or have been waived. different from the uses established in this section do not exist or have been [59 FR 63897, Dec. 12, 1994] waived. § 184.1854 Sucrose. [53 FR 44876, Nov. 7, 1988]

(a) Sucrose (C12H22O11, CAS Reg. No. 57–50–11–1) sugar, cane sugar, or beet § 184.1859 Invert sugar. sugar is the chemical b-D- (a) Invert sugar (CAS Reg. No. 8013– fructofuranosyl-a-D-glucopyranoside. 17–0) is an aqueous solution of inverted Sucrose is obtained by crystallization or partly inverted, refined or partly re- from sugar cane or sugar beet juice fined sucrose, the solids of which con- that has been extracted by pressing or tain not more than 0.3 percent by

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weight of ash. The solution is colorless, equivalent corn starch hydrolysate by odorless, and flavorless, except for partial enzymatic conversion of glu- sweetness. It is produced by the hydrol- cose (dextrose) to fructose using an in- ysis or partial hydrolysis of sucrose soluble glucose isomerase enzyme prep- with safe and suitable acids or en- aration described in § 184.1372. The zymes. product containing more than 50 per- (b) FDA is developing food-grade cent fructose (dry weight) is prepared specifications for invert sugar in co- through concentration of the fructose operation with the National Academy portion of the mixture containing less of Sciences. In the interim, this ingre- than 50 percent fructose. dient must be of a purity suitable for (b) The ingredient shall conform to its intended use. the identity and specifications listed in (c) In accordance with § 184.1(b)(1), the monograph entitled ‘‘High-Fruc- the ingredient is used in food with no tose Corn Syrup’’ in the Food Chemi- limitation other than current good cals Codex, 4th ed. (1996), pp. 191–192, manufacturing practice. which is incorporated by reference in (d) Prior sanctions for this ingredient accordance with 5 U.S.C. 552(a) and 1 different from the uses established in CFR part 51. Copies are available from this section do not exist or have been the Office of Premarket Approval, Cen- waived. ter for Food Safety and Applied Nutri- [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, tion (HFS–200), Food and Drug Admin- 1989] istration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be ex- § 184.1865 Corn syrup. amined at the Center for Food Safety (a) Corn syrup, commonly called and Applied Nutrition’s Library, 5100 ‘‘glucose sirup’’ or ‘‘glucose syrup,’’ is Paint Branch Pkwy., College Park, MD obtained by partial hydrolysis of corn 20740, or at the Office of the Federal starch with safe and suitable acids or Register, 800 North Capitol St. NW., enzymes. It may also occur in the de- suite 700, Washington, DC. hydrated form (dried glucose sirup). (c) In accordance with § 184.1(b)(1), Depending on the degree of hydrolysis, the ingredient is used in food with no corn syrup may contain, in addition to limitation other than current good glucose, maltose and higher manufacturing practice. saccharides. [61 FR 43450, Aug.23, 1996] (b) The ingredient meets the specifications as defined and determined in § 184.1875 Thiamine hydrochloride. § 168.120(b) or § 168.121(a) of this chapter, (a) Thiamine hydrochloride as appropriate. FDA, in cooperation (C12H17C1N4OS·HCl, CAS Reg. No. 67–03– with the National Academy of 8) is the chloride-hydrochloride salt of Sciences, is undertaking a study to de- thiamine. It occurs as hygroscopic termine if additional food-grade speci- white crystals or a white crystalline fications for corn syrup are necessary. powder. The usual method of preparing (c) In accordance with § 184.1(b)(1), this substance is by linking the the ingredient is used in food with no preformed thiazole and pyrimidine ring limitation other than current good systems. manufacturing practice. (b) The ingredient meets the speci- (d) Prior sanctions for this ingredient fications of the Food Chemicals Codex, different from the uses established in 3d Ed. (1981), p. 324, which is incor- this section do not exist or have been porated by reference. Copies are avail- waived. able from the National Academy Press, [53 FR 44876, Nov. 7, 1988] 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- § 184.1866 High fructose corn syrup. spection at the Office of the Federal (a) High fructose corn syrup, a sweet, Register, 800 North Capitol Street, nutritive saccharide mixture con- NW., suite 700, Washington, DC 20408. taining either approximately 42 or 55 (c) In accordance with § 184.1(b)(1), percent fructose, is prepared as a clear the ingredient is used in food with no aqueous solution from high dextrose- limitation other than current good

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manufacturing practice. The affirma- (2) The ingredient is used in food at tion of this ingredient as generally rec- levels not to exceed current good man- ognized as safe (GRAS) as a direct ufacturing practice. Thiamine mono- human food ingredient is based upon nitrate may be used in infant formula the following current good manufac- in accordance with section 412(g) of the turing practice conditions of use: Federal Food, Drug, and Cosmetic Act (1) The ingredient is used as a fla- (the Act) or with regulations promul- voring agent and adjuvant as defined in gated under section 412(a)(2) of the Act. § 170.3(o)(12) of this chapter or as a nu- (d) Prior sanctions for this ingredient trient supplement as defined in different from the uses established in § 170.3(o)(20) of this chapter. this section do not exist or have been (2) The ingredient is used in food at waived. levels not to exceed current good manufacturing practice. Thiamine hydro- [48 FR 55124, Dec. 9, 1983] chloride may be used in infant formula § 184.1890 α-Tocopherols. in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (a) The a-tocopherols that are the (the Act) or with regulations promul- subject of this GRAS affirmation regu- gated under section 412(a)(2) of the Act. lation are limited to the following: (d) Prior sanctions for this ingredient (1) d-a-Tocopherol (CAS Reg. No. 59– different from the uses established in 02–9) is the chemical [2R,4′R,8prime;R]- this section do not exist or have been 2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyl- waived. tridecyl)-6-chromanol. It occurs commercially as a concentrate and is a red, [48 FR 55124, Dec. 9, 1983] nearly odorless, viscous oil. It is obtained by vacuum steam distillation of § 184.1878 Thiamine mononitrate. edible vegetable oil products. (a) Thiamine mononitrate (2) dl-a-Tocopherol (CAS Reg. No. (C12H17N5O4S, CAS Reg. No. 532–43–4) is 10191–41–0) is a mixture of the mononitrate salt of thiamine. It stereoisomers of 2,5,7,8-tetramethyl-2- occurs as white crystals or a white (4′,8′,12′-trimethyl-tridecyl)-6- crystalline powder and is prepared chromanol. It is chemically syn- from thiamine hydrochloride by dis- thesized by condensing racemic solving the hydrochloride salt in alka- isophytol with trimethyl hydro- line solution followed by precipitation quinone. It is a pale yellow viscous oil of the nitrate half-salt with a stoichio- at room temperature. metric amount of nitric acid. (b) The ingredients meet the speci- (b) The ingredient meets the specifications of the Food Chemicals Codex, fications of the Food Chemicals Codex, 3d Ed. (1981), pp. 330–331, which is incor- 3d Ed. (1981), p. 325, which is incorporated by reference. Copies are avail- porated by reference. Copies are available from the National Academy Press, able from the National Academy Press, 2101 Constitution Ave. NW., Wash- 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- ington, DC 20418, or available for inspection at the Office of the Federal spection at the Office of the Federal Register, 800 North Capitol Street, Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. NW., suite 700, Washington, DC 20408. (c) In accordance with § 184.1(b)(3), (c) In accordance with § 184.1(b)(1), the affirmation of the ingredients as the ingredient is used in food with no generally recognized as safe is limited limitation other than current good to the following conditions of use while manufacturing practice. The affirma- the agency concludes the general eval- tion of this ingredient as generally rec- uation of all food uses of tocopherols: ognized as safe (GRAS) as a direct (1) The ingredients are used as inhibi- human food ingredient is based upon tors of nitrosamine formation. the following current good manufac- (2) The ingredients are used in pump- turing practice conditions of use: cured bacon at levels not to exceed cur- (1) The ingredient is used as a nutri- rent good manufacturing practice. ent supplement as defined in § 170.3(o)(20) of this chapter. [49 FR 13348, Apr. 4, 1984]

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§ 184.1901 Triacetin. § 170.3(n)(25) of this chapter; and soft candy as defined in § 170.3(n)(38) of this (a) Triacetin (C8 H14O6, CAS Reg. No. 102–76–1), also known as 1,2,3,- chapter. propanetriol triacetate or glyceryl (d) Prior sanctions for this ingredient triacetate, is the triester of glycerin different from the uses established in and acetic acid. Triacetin can be pre- this section do not exist or have been pared by heating glycerin with acetic waived. anhydride alone or in the presence of [54 FR 7404, Feb. 21, 1989] finely divided potassium hydrogen sulfate. It can also be prepared by the re- § 184.1903 Tributyrin. action of oxygen with a liquid-phase mixture of allyl acetate and acetic acid (a) Tributyrin (C15H26O6, CAS Reg. using a bromide salt as a catalyst. No. 60–01–5), also known as butyrin or (b) The ingredient meets the speci- glyceryl tributyrate, is the triester of fications of the Food Chemicals Codex, glycerin and butyric acid. It is pre- 3d Ed. (1981), pp. 337–338, as revised by pared by esterification of glycerin with the First Supplement to the 3d Ed., excess butyric acid. which is incorporated by reference in (b) The ingredient meets the speci- accordance with 5 U.S.C. 552(a). Copies fication of the Food Chemicals Codex, are available from the National Acad- 3d Ed. (1981), p. 416, which is incor- emy Press, 2102 Constitution Ave., NW., porated by reference in accordance Washington, DC 20418, or available for with 5 U.S.C. 552(a). Copies are avail- inspection at the Office of the Federal able from the National Academy Press, Register, 800 North Capitol Street, 2101 Constitution Ave. NW., Wash- NW., suite 700, Washington, DC 20005. (c) In accordance with § 184.1(b)(1), ington, DC 20418, or available for in- the ingredient is used in food with no spection at the Office of the Federal limitation other than current good Register, 800 North Capitol Street, manufacturing practice. The affirma- NW., suite 700, Washington, DC 20005. tion of this ingredient as generally rec- (c) In accordance with § 184.1(b)(1), ognized as safe (GRAS) as a direct the ingredient is used in food with no human food ingredient is based upon limitation other than current good the following current good manufac- manufacturing practice. The affirma- turing practice conditions of use: tion of this ingredient as generaly rec- (1) The ingredient is used in food as a ognized as safe (GRAS) as a direct flavoring agent and adjuvant as defined human food ingredient is based upon in § 170.3(o)(12) of this chapter; a formu- the following current good manufac- lation aid as defined in § 170.3(o)(14) of turing practice conditions of use: this chapter; and humectant as defined (1) The ingredient is used in food as a in § 170.3(o)(16) of this chapter; and a flavoring agent and adjuvant as defined solvent and vehicle as defined in in § 170.3(o)(12) of this chapter. § 170.3(o)(27) of this chapter. (2) The ingredient is used in the fol- (2) The ingredient is used in the following foods at levels not to exceed lowing foods at levels not to exceed current good manufacturing practice; current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of baked goods and baking mixes as de- this chapter; alcoholic beverages as defined in § 170.3(n)(1) of this chapter, alcoholic beverages as defined in fined in § 170.3(n)(2) of this chapter; § 170.3(n)(2) of this chapter; non- nonalcoholic beverages as defined in alcoholic beverages and beverage bases § 170.3(n)(3) of this chapter; fats and oils as defined in § 170.3(n)(3) of this chap- as defined in § 170.3(n)(12) of this chapter; chewing gum as defined in ter; frozen dairy desserts and mixes as § 170.3(n)(6) of this chapter; confections defined in § 170.3(n)(20) of this chapter; and frostings as defined in § 170.3(n)(9) gelatins, puddings and fillngs as de- of this chapter; frozen dairy dessert fined in § 170.3(n)(22) of this chapter; and mixes as defined in § 170.3(n)(20) of and soft candy as defined in this chapter; gelatins, puddings, and § 170.3(n)(38) of this chapter. fillngs as defined in § 170.3(n)(22) of this (d) Prior sanctions for this ingredient chapter; hard candy as defined in different from the uses established in

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this section do not exist or have been enzyme activity is that of a peptide hy- waived. drolase (EC 3.4.21.4). (b) The ingredient meets the general [54 FR 7404, Feb. 21, 1989; 54 FR 10482, Mar. 13, 1989] requirements and additional requirements for enzyme preparations in the § 184.1911 Triethyl citrate. Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference (a) Triethyl citrate (C H O , CAS 12 20 7 in accordance with 5 U.S.C. 552(a) and 1 Reg. No. 77–93–0) is the triethyl ester of CFR part 51. Copies are available from citric acid. It is prepared by esterifying the National Academy Press, 2101 Con- citric acid with ethyl alcohol and oc- stitution Ave. NW., Washington, DC curs as an odorless, practically colorless, oily liquid. 20418, or may be examined at the Office of Premarket Approval (HFS–200), Food (b) The ingredient meets the speci- and Drug Administration, 5100 Paint fications of the Food Chemicals Codex, Branch Pkwy., College Park, MD 20740, 3d ed. (1981), p. 339, which is incor- and the Office of the Federal Register, porated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 800 North Capitol St. NW., suite 700, Copies are available from the National Washington, DC. Academy Press, 2101 Constitution Ave. (c) In accordance with § 184.1(b)(1), NW., Washington, DC 20418, and the the ingredient is used in food with no Center for Food Safety and Applied Nu- limitation other than current good trition (HFS–200), 5100 Paint Branch manufacturing practice. The affirma- Pkwy., College Park, MD 20740, or may tion of this ingredient as GRAS as a di- be examined at the Office of the Fed- rect food ingredient is based upon the eral Register, 800 North Capitol St. following current good manufacturing NW., suite 700, Washington, DC. practice conditions of use: (c) In accordance with § 184.1(b)(1), (1) The ingredient is used as an en- the ingredient is used in food with no zyme as defined in § 170.3(o)(9) of this limitation other than current good chapter to hydrolyze proteins or manufacturing practice. The affirma- polypeptides. tion of this ingredient as generally rec- (2) The ingredient is used in food at ognized as safe (GRAS) as a direct levels not to exceed current good man- human food ingredient is based upon ufacturing practice. the following current good manufac- [60 FR 32911, June 26, 1995] turing practice conditions of use: (1) The ingredient is used as a fla- § 184.1923 Urea. voring agent as defined in § 170.3(o)(12) of this chapter; a solvent and vehicle as (a) Urea (CO(NH2)2, CAS Reg. No. 57– defined in § 170.3(o)(27) of this chapter; 13–6) is the diamide of carbonic acid and a surface-active agent as defined in and is also known as carbamide. It is a § 170.3(o)(29) of this chapter. white, odorless solid and is commonly (2) The ingredient is used in foods at produced from CO2 by ammonolysis or levels not to exceed current good man- from cyanamide by hydrolysis. ufacturing practice. (b) FDA is developing food-grade (d) Prior sanctions for this ingredient specifications for urea in cooperation different from the uses established in with the National Academy of this section, or different from those set Sciences. In the interim, this ingre- forth in part 181 of this chapter, do not dient must be of a purity suitable for exist or have been waived. its intended use. (c) In accordance with § 184.1(b)(1), [59 FR 63897, Dec. 12, 1994] the ingredient is used in food with no limitation other than current good § 184.1914 Trypsin. manufacturing practice. The affirma- (a) Trypsin (CAS Reg. No. 9002–07–7) tion of this ingredient as generally rec- is an enzyme preparation obtained ognized as safe as a direct human food from purified extracts of porcine or bo- ingredient is based upon the following vine pancreas. It is a white to tan current good manufacturing practice amorphous powder. Its characterizing conditions of use:

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(1) The ingredient is used as a formu- this ingredient in wine to inhibit for- lation aid as defined in § 170.3(o)(14) of mation of ethyl carbamate. this chapter and as a fermentation aid. (2) The ingredient is used in yeast- [57 FR 60473, Dec. 21, 1992] raised bakery products; in alcoholic beverages as defined in § 170.3(n)(2) of § 184.1930 Vitamin A. this chapter; and in gelatin products. (a)(1) Vitamin A (retinol; CAS Reg. (d) Prior sanctions for this ingredient No. 68–26–8) is the alcohol 9,13-di- different from the uses established in methyl-7-(1,1,5-trimethyl-6-cyclohexen- this section do not exist or have been 5-yl)-7,9,11,13-nonatetraen-15-ol. It may waived. be nearly odorless or have a mild fishy [48 FR 51616, Nov. 10, 1983, as amended at 49 odor. Vitamin A is extracted from fish FR 19816, May 10, 1984] liver oils or produced by total synthesis from b-ionone and a propargyl § 184.1924 Urease enzyme preparation halide. from Lactobacillus fermentum. (2) Vitamin A acetate (retinyl ace- (a) This enzyme preparation is de- tate; CAS Reg. No. 127–47–9) is the ace- rived from the nonpathogenic, tate ester of retinol. It is prepared by nontoxicogenic bacterium Lactobacillus esterifying retinol with acetic acid. fermentum. It contains the enzyme (3) Vitamin A palmitate (retinyl urease (CAS Reg. No. 9002–13–5), which palmitate; CAS Reg. No. 79–81–2) is the facilitates the hydrolysis of urea to palmitate ester of retinol. It is pre- ammonia and carbon dioxide. It is pro- pared by esterifying retinol with pal- duced by a pure culture fermentation mitic acid. process and by using materials that are generally recognized as safe (GRAS) or (b) The ingredient meets the speci- are food additives that have been ap- fications for vitamin A in the Food proved for this use by the Food and Chemicals Codex, 3d Ed. (1981), p. 342, Drug Administration (FDA). which is incorporated by reference. (b) The ingredient meets the general Copies are available from the National and additional requirements for en- Academy Press, 2101 Constitution Ave. zyme preparations in the ‘‘Food Chemi- NW., Washington, DC 20418, or avail- cals Codex,’’ 3d ed. (1981), pp. 107–110, able for inspection at the Office of the which is incorporated by reference in Federal Register, 800 North Capitol accordance with 5 U.S.C. 552(a) and 1 Street, NW., suite 700, Washington, DC CFR part 51. Copies are available from 20408. the National Academy Press, 2101 Con- (c) In accordance with § 184.1(b)(1), stitution Ave. NW., Washington, DC the ingredient is used in food with no 20418, or available for inspection at the limitation other than current good Office of the Federal Register, 800 manufacturing practice. The affirma- North Capitol St. NW., suite 700, Wash- tion of this ingredient as generally rec- ington, DC. ognized as safe (GRAS) as a direct (c) In accordance with § 184.1(b)(1), human food ingredient is based upon the ingredient is used in food with no the following current good manufac- limitation other than current good turing practice conditions of use: manufacturing practice. The affirma- (1) The ingredient is used in food as a tion of this ingredient as GRAS as a di- nutrient supplement as defined in rect human food ingredient is based § 170.3(o)(20) of this chapter. upon the following current good manufacturing practice conditions of use: (2) The ingredient is used in foods at (1) The ingredient is used in wine, as levels not to exceed current good man- defined in 27 CFR 2.5 and 4.10, as an en- ufacturing practice. Vitamin A may be zyme as defined in § 170.3(o)(9) of this used in infant formula in accordance chapter to convert urea to ammonia with section 412(g) of the Federal Food, and carbon dioxide. Drug, and Cosmetic Act (the act) or (2) The ingredient is used in food at with regulations promulgated under levels not to exceed current good man- section 412(a)(2) of the Act. ufacturing practice. Current good man- (d) Prior sanctions for this ingredient ufacturing practice is limited to use of different from the uses established in

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this section do not exist or have been (2) Crystalline vitamin D3 (C27H44O, waived. CAS Reg. No. 67–97–0), also known as [48 FR 51610, Nov. 10, 1983] cholecalciferol, is the chemical 9,10- seco(5Z,7E,)-5,7,10(19)-cholestatrien-3-

§ 184.1945 Vitamin B12. ol. Vitamin D3 occurs in, and is iso- (a) Vitamin B , also known as cyano- lated from, fish liver oils. It is also 12 manufactured by ultraviolet irradia- cobalamin (C63H88CoN14O14P, CAS Reg. No. 68–0919–099), is produced commer- tion of 7-dehydrocholesterol produced cially from cultures of Streptomyces from cholesterol. It is purified by crys- griseus. tallization. Vitamin D3 is the vitamin (b) The ingredient meets the speci- D form that is produced endogenously fications of the Food Chemicals Codex, in humans through sunlight activation 3d Ed. (1981), p. 343, which is incor- of 7-dehydrocholesterol in the skin. porated by reference. Copies are avail- (3) Vitamin D2 resin and vitamin D3 able from the National Academy Press, resin are the concentrated forms of ir- 2101 Constitution Ave. NW., Wash- radiated ergosterol (D2) and irradiated ington, DC 20418, or available for in- 7-dehydrocholesterol (D3) that are sepa- spection at the Office of the Federal rated from the reacting materials in Register, 800 North Capitol Street, paragraphs (a) (1) and (2) of this sec- NW., suite 700, Washington, DC 20408. tion. The resulting products are sold as (c) In accordance with § 184.1(b)(1), food sources of vitamin D without fur- the ingredient is used in food with no ther purification.

limitation other than current good (b) Vitamin D2 and vitamin D3 as manufacturing practice. The affirma- crystals meet the specifications of the tion of this ingredient as generally rec- Food Chemicals Codex, 3d Ed. (1981), ognized as safe (GRAS) as a direct pp. 344 and 345, which is incorporated human food ingredient is based upon by reference. Copies are available from the following current good manufac- the National Academy Press, 2101 Con- turing practice conditions of use: stitution Ave. NW., Washington, DC (1) The ingredient is used as a nutri- 20418, or available for inspection at the ent supplement as defined in Office of the Federal Register, 800 § 170.3(o)(20) of this chapter. North Capitol Street, NW., suite 700, (2) The ingredient is used in food at Washington, DC 20408. FDA is devel- levels not to exceed current good man- oping food-grade specifications for vi- ufacturing practice. Vitamin B12 also tamin D2 resin and vitamin D3 resin in may be used in infant formula in ac- cooperation with the National Acad- cordance with section 412(g) of the Fed- emy of Sciences. In the interim, these eral Food, Drug, and Cosmetic Act (the resins must be of a purity suitable for act) or with regulations promulgated their intended use. under section 412(a)(2) of the act. (c)(1) In accordance with § 184.1(b)(2), (d) Prior sanctions for this ingredient the ingredients are used in food as the different from the uses established in sole source of added vitamin D only this section do not exist or have been within the following specific limita- waived. tions: [50 FR 6341, Feb. 15, 1985] Category of food Maximum levels in Functional use § 184.1950 Vitamin D. food (as served) (a) Vitamin D is added to food as the Breakfast cereals, 350 (IU/100 Nutrient supple- following food ingredients: § 170.3(n)(4) of grams). ment, this chapter. § 170.3(o)(20) of (1) Crystalline vitamin D2 (C28H44O, this chapter. CAS Reg. No. 50–14–6), also known as Grain products and 90(IU/100 grams) Do. ergocalciferol, is the chemical 9,10- pastas, seco(5Z,7E,22E)-5,7,10(19),22- § 170.3(n)(23) of this chapter. ergostatetraen-3-ol. The ingredient is Milk, § 170.3(n)(30) 42 (IU/100 grams) Do. produced by ultraviolet irradiation of of this chapter. ergosterol isolated from yeast and re- Milk products, 89 (IU/100 grams) Do. lated fungi and is purified by crys- § 170.3(n)(31) of tallization. this chapter.

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(2) Vitamin D may be used in infant 0.04 percent for hard candy as defined formula in accordance with section in § 170.3(n)(25) of this chapter; 0.1 per- 412(g) of the Federal Food, Drug, and cent for soft candy as defined in Cosmetic Act (the act) or with regula- § 170.3(n)(38) of this chapter; and 0.002 tions promulgated under section percent or less for all other food cat- 412(a)(2) of the act. egories. (3) Vitamin D may be used in mar- garine in accordance with § 166.110 of [43 FR 14644, Apr. 7, 1978, as amended at 49 FR 5613, Feb. 14, 1984; 50 FR 49536, Dec. 3, this chapter. 1985] (d) Prior sanctions for these ingredients different from the uses established § 184.1976 Candelilla wax. in this section do not exist or have been waived. (a) Candelilla wax (CAS Reg. No. 8006–44–8) is obtained from the can- [50 FR 30152, July 24, 1985] delilla plant. It is a hard, yellowish- brown, opaque-to-translucent wax. § 184.1973 Beeswax (yellow and white). Candelilla wax is prepared by immers- (a) Beeswax (CAS Reg. No. 8012–89–3) ing the plants in boiling water con- is a secretory product of honey bees taining sulfuric acid and skimming off used as a structural material in honey- the wax that rises to the surface. It is combs. Beeswax is prepared from hon- composed of about 50 percent hydro- eycombs after removal of the honey by carbons with smaller amounts of esters draining or centrifuging. The combs and free acids. are melted in hot water or steam or (b) The ingredient meets the speci- with solar heat, and strained. The wax fications of the Food Chemicals Codex, is refined by melting in hot water to 3d Ed. (1981), p. 67, which is incor- which sulfuric acid or alkali may be porated by reference. Copies are avail- added to extract impurities. The re- able from the National Academy Press, sulting wax is referred to as yellow 2101 Constitution Ave. NW., Wash- beeswax. White beeswax is produced by ington, DC 20418, or available for in- bleaching the constituent pigments of spection at the Office of the Federal yellow beeswax with peroxides, or pref- Register, 800 North Capitol Street, erably it is bleached by sun light. NW., suite 700, Washington, DC 20408. (b) The ingredient meets the speci- (c) In accordance with § 184.1(b)(1), fications of the ‘‘Food Chemicals the ingredient is used in food with no Codex,’’ 3d Ed. (1981), pp. 34–35, which is limitation other than current good incorporated by reference. Copies may manufacturing practice. The affirma- be obtained from the National Acad- tion of this ingredient as generally rec- emy Press, 2101 Constitution Ave. NW., ognized as safe (GRAS) as a direct Washington, DC 20418, or may be exam- human food ingredient is based upon ined at the Office of the Federal Reg- the following current good manufac- ister, 800 North Capitol Street, NW., turing practice conditions of use: suite 700, Washington, DC 20408. (1) The ingredient is used as a lubri- (c) The ingredient is used as a fla- cant as defined in § 170.3(o)(18) of this voring agent and adjuvant as defined in chapter and as a surface-finishing § 170.3(o)(12) of this chapter, as a lubri- agent as defined in § 170.3(o)(30) of this cant as defined in § 170.3(o)(18) of this chapter. chapter, and as a surface-finishing (2) The ingredient is used in the fol- agent as defined in § 170.3(o)(30) of this lowing foods at levels not to exceed chapter. current good manufacturing practice: (d) The ingredient is used in food, in in chewing gum as defined in accordance with § 184.1(b)(1) of this § 170.3(n)(6) of this chapter and in hard chapter, at levels not to exceed good candy as defined in § 170.3(n)(25) of this manufacturing practice. Current good chapter. manufacturing practice results in a (d) Prior sanctions for this ingredient maximum level, as served, of: 0.065 per- different from the uses established in cent for chewing gum as defined in this section do not exist or have been § 170.3(n)(6) of this chapter; 0.005 per- waived. cent for confections and frostings as defined in § 170.3(n)(9) of this chapter; [48 FR 51617, Nov. 10, 1983]

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§ 184.1978 Carnauba wax. (d) Prior sanctions for this ingredient (a) Carnauba wax (CAS Reg. No. 008– different from the uses established in 015–869) is obtained from the leaves and this section do not exist or have been buds of the Brazilian wax palm waived. Copernicia cerifera Martius. The wax is [48 FR 51147, Nov. 7, 1983] hard, brittle, sparingly soluble in cold organic solvents and insoluble in § 184.1979 Whey. water. It is marketed in five grades (a)(1) Whey. Whey is the liquid sub- designated No. 1 through No. 5. Grades No. 4 and No. 5 represent the bulk of stance obtained by separating the co- the commercial trade volume. These agulum from milk, cream, or skim commercial grades consist chiefly of milk in cheesemaking. Whey obtained from a procedure, in which a signifi- C24 to C32 normal saturated monofunctional fatty acids and normal cant amount of lactose is converted to saturated monofunctional primary al- lactic acid, or from the curd formation cohols. by direct acidification of milk, is (b) The ingredient meets the speci- known as acid whey. Whey obtained fications of the Food Chemicals Codex, from a procedure in which there is in- 3d Ed. (1981), p. 73, which is incor- significant conversion of lactose to lac- porated by reference. Copies are avail- tic acid is known as sweet whey. Sweet able from the National Academy Press, whey has a maximum titratable acid- 2101 Constitution Ave. NW., Wash- ity of not more than 0.16 percent, cal- ington, DC 20418, or available for in- culated as lactic acid, and an alka- spection at the Office of the Federal linity of ash of not more than 225 milli- Register, 800 North Capitol Street, liters of 0.1N hydrochloric acid per 100 NW., suite 700, Washington, DC 20408. grams. The acidity of whey, sweet or (c) In accordance with § 184.1(b)(1), acid, may be adjusted by the addition the ingredient is used in food with no of safe and suitable pH-adjusting ingre- limitation other than current good dients. manufacturing practice. The affirma- (2) Concentrated whey. Concentrated tion of this ingredient as generally rec- whey is the liquid substance obtained ognized as safe (GRAS) as a direct by the partial removal of water from human food ingredient is based upon whey, while leaving all other constitu- the following current good manufac- ents in the same relative proportions turing practice conditions of use: as in whey. (1) The ingredient is used as an anticaking agent as defined § 170.3(o)(1) (3) Dry or dried whey. Dry or dried of this chapter; as a formulation aid as whey is the dry substance obtained by defined in § 170.3(o)(14) of this chapter; the removal of water from whey, while as a lubricant and release agent as de- leaving all other constituents in the fined in § 170.3(o)(18) of this chapter; same relative proportions as in whey. and as a surface-finishing agent as de- (b) The ingredients meet the fol- fined in § 170.3(o)(30) of this chapter. lowing specifications: (2) The ingredient is used in the fol- (1) The analysis of whey, con- lowing foods at levels not to exceed centrated whey, and dry (dried) whey, current good manufacturing practice: on a dry product basis, based on ana- baked goods and baking mixes as de- lytical methods in the referenced sec- fined in § 170.3(n)(1) of this chapter; tions of ‘‘Official Methods of Analysis chewing gun as defined in § 170.3(n)(6) of of the Association of Official Analyt- this chapter; confections and frostings ical Chemists,’’ 13th ed. (1980), which is as defined in § 170.3(n)(9) of this chap- incorporated by reference in accord- ter; fresh fruits and fruit juices as de- ance with 5 U.S.C. 552(a) and 1 CFR fined in § 170.3(n)(16) of this chapter; part 51, is given in paragraphs (b)(1)(i) gravies and sauces as defined in through (b)(1)(vii) of this section. Cop- § 170.3(n)(24) of this chapter; processed ies may be obtained from the Associa- fruits and fruit juices as defined in tion of Official Analytical Chemists § 170.3(n)(35) of this chapter; and soft International, 481 North Frederick candy as defined in § 170.3(n)(38) of this Ave., suite 500, Gaithersburg, MD 20877– chapter. 2504, or may be examined at the Center

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for Food Safety and Applied Nutri- (2) Limits of impurities are: Heavy tion’s Library, Food and Drug Admin- metals (as lead). Not more than 10 istration, 5100 Paint Branch Pkwy., parts per million (0.001 percent) as de- College Park, MD 20740, or at the Office termined by the method described in of the Federal Register, 800 North Cap- the ‘‘Food Chemicals Codex,’’ 4th ed. itol St. NW., suite 700, Washington, DC. (1996), pp. 760–761, which is incorporated (i) Protein content, 10 to 15 percent— by reference in accordance with 5 as determined by the methods pre- U.S.C. 552(a) and 1 CFR part 51. Copies scribed in section 16.036 (liquid sample), are available from the National Acad- entitled ‘‘Total Nitrogen—Official emy Press, Box 285, 2101 Constitution Final Action’’ under the heading Ave. NW., Washington, DC 20055 (Inter- ‘‘Total Solids,’’ or in section 16.193 (dry net address http://www.nap.edu), or sample), entitled ‘‘Kjeldahl Method’’ may be examined at the Center for under the heading ‘‘Protein—Official Food Safety and Applied Nutrition’s Final Action.’’ Library, Food and Drug Administra- (ii) Fat content, 0.2 to 2.0 percent—as tion, 5100 Paint Branch Pkwy., College determined by the methods prescribed Park, MD 20740, or at the Office of the in section 16.059 (liquid sample), Federal Register, 800 North Capitol St. ‘‘Reese-Gottlieb Method [Reference NW., suite 700, Washington, DC. Method] (11)—Official Final Action’’ (3) The whey must be derived from under the heading ‘‘Fat,’’ or in section milk that has been pasteurized, or the 16.199 (dry sample), entitled ‘‘Fat in whey and modified whey product must Dried Milk (45)—Official Final Action.’’ be subjected to pasteurization tech- (iii) Ash content, 7 to 14 percent—as niques or its equivalent before use in determined by the methods prescribed food. in section 16.035 (liquid sample), enti- (c) Whey, concentrated whey, and dry tled ‘‘Ash (5)—Official Final Action’’ (dried) whey may be used in food in ac- under the heading ‘‘Total Solids,’’ or in cordance with good manufacturing section 16.196 (dry sample), entitled practice as indicated in § 184.1(b)(1). ‘‘Ash—Official Final Action’’ under the (d) The label on the whey form sold heading ‘‘Dried Milk, Nonfat Dry Milk, to food manufacturers shall read as fol- and Malted Milk.’’ lows: (iv) Lactose content, 61 to 75 per- (1) For whey: ‘‘(Sweet or acid) whey’’ cent—as determined by the methods or ‘‘whey (ll% titratable acidity). prescribed in section 16.057 (liquid sam- (2) For concentrated whey: ‘‘Con- ple), entitled ‘‘Gravimetric Method— centrated (sweet or acid) whey, ll% Official Final Action’’ under the head- solids’’ or ‘‘Concentrated whey (ll% ing ‘‘Lactose,’’ or in section 31.061 (dry titratable acidity), ll% solids’’. sample), entitled ‘‘Lane-Eynon General (3) For dry (dried) whey: ‘‘Dry (dried) Volumetric Method’’ under the heading (sweet or acid) whey’’ or ‘‘dry (dried) ‘‘Lactose—Chemical Methods—Official whey, (ll% titratable acidity)’’. Final Action.’’ (e) Whey, concentrated whey, or dry (v) Moisture content, 1 to 8 percent— (dried) whey in a finished food product as determined by the methods pre- shall be listed as ‘‘whey.’’ scribed in section 16.192, entitled [46 FR 44439, Sept. 4, 1981; 47 FR 7410, Feb. 19, ‘‘Moisture (41)—Official Final Action’’ 1982, as amended at 54 FR 24899, June 12, 1989; under the heading ‘‘Dried Milk, Nonfat 64 FR 1760, Jan. 12, 1999] Dry Milk, and Malted Milk.’’ (vi) Solids content, variable—as de- § 184.1979a Reduced lactose whey. termined by the methods prescribed in (a) Reduced lactose whey is the sub- section 16.032, entitled ‘‘Method I—Offi- stance obtained by the removal of lac- cial Final Action’’ under the heading tose from whey. The lactose content of ‘‘Total Solids.’’ the finished dry product shall not ex- (vii) Titratable Acidity, variable—as ceed 60 percent. Removal of the lactose determined by the methods prescribed is accomplished by physical separation in section 16.023, entitled ‘‘Acidity (2)— techniques such as precipitation, filtra- Official Final Action’’ under the head- tion, or dialysis. As with whey, reduced ing ‘‘Milk,’’ or by an equivalent poten- lactose whey can be used as a fluid, tiometric method. concentrate, or a dry product form.

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The acidity of reduced lactose whey General Volumetric Method’’ under the may be adjusted by the addition of safe heading ‘‘Lactose—Chemical Meth- and suitable pH-adjusting ingredients. ods—Official Final Action.’’ (b) The reduced lactose whey meets (v) Moisture content, 1 to 6 percent— the following specifications: as determined by the method pre- (1) The analysis of reduced lactose scribed in section 16.192, entitled whey, on a dry product basis, based on ‘‘Moisture (41)—Official Final Action’’ analytical methods in the referenced under the heading ‘‘Dried Milk, Nonfat sections of ‘‘Official Methods of Anal- Dry Milk, and Malted Milk.’’ ysis of the Association of Official Ana- (vi) Solids content, variable—as de- lytical Chemists,’’ 13th ed. (1980), which termined by the methods prescribed in is incorporated by reference in accord- section 16.032, entitled ‘‘Method I—Offi- ance with 5 U.S.C. 552(a) and 1 CFR cial Final Action’’ under the heading part 51, is given in paragraphs (b)(1)(i) ‘‘Total Solids.’’ through (b)(1)(vii) of this section. Cop- (vii) Titratable Acidity, variable—as ies may be obtained from the Associa- determined by the methods prescribed tion of Official Analytical Chemists in section 16.023, entitled ‘‘Acidity (2)— International, 481 North Frederick Official Final Action’’ under the head- Ave., suite 500, Gaithersburg, MD 20877– ing ‘‘Milk,’’ or by an equivalent poten- 2504, or may be examined at the Center tiometric method. for Food Safety and Applied Nutri- (2) Limits of impurities are: Heavy tion’s Library, Food and Drug Admin- metals (as lead). Not more than 10 istration, 5100 Paint Branch Pkwy., parts per million (0.001 percent), as de- College Park, MD 20740, or at the Office termined by the method described in of the Federal Register, 800 North Cap- the ‘‘Food Chemicals Codex,’’ 4th ed. itol St. NW., suite 700, Washington, DC. (1996), pp. 760–761, which is incorporated (i) Protein content, 16 to 24 percent— by reference in accordance with 5 as determined by the methods pre- U.S.C. 552(a) and 1 CFR part 51. Copies scribed in section 16.036 (liquid sample), are available from the National Acad- entitled ‘‘Total Nitrogen—Official emy Press, Box 285, 2101 Constitution Final Action’’ under the heading Ave. NW., Washington, DC 20055 (Inter- ‘‘Total Solids,’’ or in section 16.193 (dry net address http://www.nap.edu), or sample), entitled ‘‘Kjeldahl Method’’ may be examined at the Center for under the heading ‘‘Protein—Official Food Safety and Applied Nutrition’s Final Action.’’ Library, Food and Drug Administra- (ii) Fat content, 1 to 4 percent—as de- tion, 5100 Paint Branch Pkwy., College termined by the methods prescribed in Park, MD 20740, or at the Office of the section 16.059 (liquid sample), ‘‘Reese- Federal Register, 800 North Capitol St. Gottlieb Method [Reference Method] NW., suite 700, Washington, DC. (11)—Official Final Action’’ under the (3) The reduced lactose whey shall be heading ‘‘Fat,’’ or in section 16.199 (dry derived from milk that has been pas- sample), entitled ‘‘Fat in Dried Milk teurized, or the reduced lactose whey (45)—Official Final Action.’’ shall be subjected to pasteurization (iii) Ash content, 11 to 27 percent—as techniques or its equivalent before use determined by the methods prescribed in food. in section 16.035 (liquid sample), enti- (c) Reduced lactose whey may be tled ‘‘Ash (5)—Official Final Action’’ used in food in accordance with good under the heading ‘‘Total Solids,’’ or in manufacturing practice as indicated in section 16.196 (dry sample), entitled § 184.1(b)(1). ‘‘Ash—Official Final Action’’ under the (d) The percent of lactose present on heading ‘‘Dried Milk, Nonfat Dry Milk, a dry product basis, i.e., ‘‘reduced lac- and Malted Milk.’’ tose whey (ll% lactose),’’ shall be de- (iv) Lactose content, not more than clared on the label of the package sold 60 percent—as determined by the meth- to food manufacturers. The percent of ods prescribed in section 16.057 (liquid lactose may be declared in 5-percent sample), entitled ‘‘Gravimetric Meth- increments, expressed as a multiple of od—Official Final Action’’ under the 5, not greater than the actual percent- heading ‘‘Lactose,’’ or in section 31.061 age of lactose in the product, or as a (dry sample), entitled ‘‘Lane–Eynon actual percentage provided that an

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analysis of the product on which the section 16.059 (liquid sample), ‘‘Reese- actual percentage is based is supplied Gottlieb Method [Reference Method] to the food manufacturer. (11)—Official Final Action’’ under the (e) The presence of reduced lactose heading ‘‘Fat,’’ or in section 16.199 (dry whey in a finished food product shall be sample), entitled ‘‘Fat in Dried Milk listed as ‘‘reduced lactose whey.’’ (45)—Official Final Action.’’ [46 FR 44440, Sept. 4, 1981, as amended at 54 (iii) Ash content, maximum 7 per- FR 24899, June 12, 1989; 64 FR 1760, Jan. 12, cent—as determined by the methods 1999] prescribed in section 16.035 (liquid sample), entitled ‘‘Ash (5)—Official Final § 184.1979b Reduced minerals whey. Action’’ under the heading ‘‘Total Sol- (a) Reduced minerals whey is the sub- ids,’’ or in section 16.196 (dry sample), stance obtained by the removal of a entitled ‘‘Ash—Official Final Action’’ portion of the minerals from whey. The under the heading ‘‘Dried Milk, Nonfat dry product shall not contain more Dry Milk, and Malted Milk.’’ than 7 percent ash. Reduced minerals (iv) Lactose content, maximum 85 whey is produced by physical separa- percent—as determined by the methods tion techniques such as precipitation, prescribed in section 16.057 (liquid sam- filtration, or dialysis. As with whey, ple), entitled ‘‘Gravimetric Method— reduced minerals whey can be used as a Official Final Action’’ under the head- fluid, concentrate, or a dry product ing ‘‘Lactose,’’ or in section 31.061 (dry form. The acidity of reduced minerals sample), entitled ‘‘Lane-Eynon General whey may be adjusted by the addi- Volumetric Method’’ under the heading tional of safe and suitable pH-adjusting ‘‘Lactose—Chemical Methods—Official ingredients. Final Action.’’ (b) The reduced minerals whey meets (v) Moisture content, 1 to 6 percent— the following specifications: as determined by the methods pre- (1) The analysis of reduced minerals scribed in section 16.192, entitled whey, on a dry product basis, based on ‘‘Moisture (41)—Official Final Action’’ analytical methods in the referenced under the heading ‘‘Dried Milk, Nonfat sections of ‘‘Official Methods of Anal- Dry Milk, and Malted Milk.’’ ysis of the Association of Official Ana- (vi) Solids content, variable—as de- lytical Chemists,’’ 13th ed. (1980), which termined by the methods prescribed in is incorporated by reference in accord- section 16.032, entitled ‘‘Method I—Offi- ance with 5 U.S.C. 552(a) and 1 CFR cial Final Action’’ under the heading part 51, is given in paragraphs (b)(1)(i) ‘‘Total Solid.’’ through (b)(1)(vii) of this section. Cop- (vii) Titratable Acidity, variable—as ies may be obtained from the Associa- determined by the methods prescribed tion of Official Analytical Chemists in section 16.023, entitled ‘‘Acidity (2)— International, 481 North Frederick Official Final Action’’ under the head- Ave., suite 500, Gaithersburg, MD 20877– ing ‘‘Milk,’’ or by an equivalent poten- 2504, or may be examined at the Center tiometric method. for Food Safety and Applied Nutri- (2) Limits of impurities are: Heavy tion’s Library, Food and Drug Admin- metals (as lead). Not more than 10 istration, 5100 Paint Branch Pkwy., parts per million (0.001 percent), as de- College Park, MD 20740, or at the Office termined by the method described in of the Federal Register, 800 North Cap- the ‘‘Food Chemicals Codex,’’ 4th ed. itol St. NW., suite 700, Washington, DC. (1996), pp. 760–761, which is incorporated (i) Protein content, 10 to 24 percent— by reference in accordance with 5 as determined by the methods pre- U.S.C. 552(a) and 1 CFR part 51. Copies scribed in section 16.036 (liquid sample), are available from the National Acad- entitled ‘‘Total Nitrogen—Official emy Press, Box 285, 2101 Constitution Final Action’’ under the heading Ave. NW., Washington, DC 20055 (Inter- ‘‘Total Solids,’’ or in section 16.193 (dry net address http://www.nap.edu), or sample), entitled ‘‘Kjeldahl Method’’ may be examined at the Center for under the heading ‘‘Protein—Official Food Safety and Applied Nutrition’s Final Action.’’ Library, Food and Drug Administra- (ii) Fat content, 1 to 4 percent—as de- tion, 5100 Paint Branch Pkwy., College termined by the methods prescribed in Park, MD 20740, or at the Office of the

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Federal Register, 800 North Capitol St. of this section. Copies may be obtained NW., suite 700, Washington, DC. from the Association of Official Ana- (3) The reduced minerals whey shall lytical Chemists International, 481 be derived from milk that has been pas- North Frederick Ave., suite 500, Gai- teurized, or the reduced minerals whey thersburg, MD 20877–2504, or may be ex- shall be subjected to pasteurization amined at the Center for Food Safety techniques or its equivalent before use and Applied Nutrition’s Library, Food in food. and Drug Administration, 5100 Paint (c) The reduced minerals whey may Branch Pkwy., College Park, MD 20740, be used in food in accordance with good or at the Office of the Federal Register, manufacturing practice as indicated in 800 North Capitol St. NW., suite 700, § 184.1(b)(1). Washington, DC. (d) The percent of minerals present (i) Protein content, minimum 25 per- on a dry product basis, i.e., ‘‘reduced cent—as determined by the methods minerals whey (ll% minerals),’’ shall prescribed in section 16.036 (liquid sam- be declared on the label of the package ple), entitled ‘‘Total Nitrogen—Offi- sold to food manufacturers. The per- cials Final Action’’ under the heading cent of minerals may be declared in 2- ‘‘Total Solids,’’ or in section 16.193 (dry percent increments expressed as a mul- sample), entitled ‘‘Kjeldahl Method’’ tiple of 2, not greater than the actual under the heading ‘‘Protein—Official percentage of minerals in the product, Final Action.’’ or as an actual percentage provided (ii) Fat content, 1 to 10 percent—as that an analysis of the product on determined by the methods prescribed which the actual percentage is based is in section 16.059 (liquid sample), supplied to the food manufacturer. ‘‘Reese-Gottlieb Method [Reference (e) The presence of reduced minerals Method] (11)—Official Final Action’’ whey in a finished food product shall be under the heading ‘‘Fat,’’ or in section listed as ‘‘reduced minerals whey’’. 16.199 (dry sample), entitled ‘‘Fat in [46 FR 44441, Sept. 4, 1981, as amended at 54 Dried Milk (45)—Official Final Action.’’ FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, (iii) Ash content, 2 to 15 percent—as 1999] determined by the methods prescribed in section 16.035 (liquid sample), enti- § 184.1979c Whey protein concentrate. tled ‘‘Ash (5)—Official Final Action’’ (a) Whey protein concentrate is the under the heading ‘‘Total Solids,’’ or in substance obtained by the removal of section 16.196 (dry sample), entitled sufficient nonprotein constituents from ‘‘Ash—Official Final Action’’ under the whey so that the finished dry product heading ‘‘Dried Milk, Nonfat Dry Milk, contains not less than 25 percent pro- and Malted Milk.’’ tein. Whey protein concentrate is pro- (iv) Lactose content, maximum 60 duced by physical separation tech- percent—as determined by the methods niques such as precipitation, filtration, prescribed in section 16.057 (liquid sam- or dialysis. As with whey, whey protein ple), entitled ‘‘Gravimetric Method— concentrate can be used as a fluid, con- Official Final Action’’ under the head- centrate, or dry product form. The ing ‘‘Lactose,’’ or in section 31.061 (dry acidity of whey protein concentrate sample), entitled ‘‘Lane-Eynon General may be adjusted by the addition of safe Volumetric Method’’ under the heading and suitable pH-adjusting ingredients. ‘‘Lactose—Chemical Methods—Official (b) The whey protein concentrate Final Action.’’ meets the following specifications: (v) Moisture content, 1 to 6 percent— (1) The analysis of whey protein con- as determined by the methods pre- centrate, on a dry product basis, based scribed in section 16.192, entitled on analytical methods in the ref- ‘‘Moisture (41)—Official Final Action’’ erenced sections of ‘‘Official Methods under the heading ‘‘Dried Milk, Nonfat of Analysis of the Association of Offi- Dry Milk, and Malted Milk.’’ cial Analytical Chemists,’’ 13th ed. (vi) Solids content, variable—as de- (1980), which is incorporated by ref- termined by the methods prescribed in erence in accordance with 5 U.S.C. section 16.032, entitled ‘‘Method I—Offi- 552(a) and 1 CFR part 51, is given in cial Final Action’’ under the heading paragraphs (b)(1)(i) through (b)(1)(vii) ‘‘Total Solids.’’

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(vii) Titratable Acidity, variable—as § 184.1983 Bakers yeast extract. determined by the methods prescribed (a) Bakers yeast extract is the food in section 16.023, entitled ‘‘Acidity (2)— ingredient resulting from concentra- Official Final Action’’ under the head- tion of the solubles of mechanically ing ‘‘Milk,’’ or by an equivalent poten- ruptured cells of a selected strain of tiometric method. yeast, Saccharomyces cerevisiae. It may (2) Limits of impurities are: Heavy be concentrated or dried. metals (as lead). Not more than 10 (b) The ingredient meets the fol- parts per million (0.001 percent), as de- lowing specifications on a dry weight termined by the method described in basis: Less than 0.4 part per million the ‘‘Food Chemicals Codex,’’ 4th ed. (ppm) arsenic, 0.13 ppm cadmium, 0.2 (1996), pp. 760–761, which is incorporated ppm lead, 0.05 ppm mercury, 0.09 ppm by reference in accordance with 5 selenium, and 10 ppm zinc. U.S.C. 552(a) and 1 CFR part 51. Copies (c) The viable microbial content of are available from the National Acad- the finished ingredient as a concentrate or dry material is: emy Press, Box 285, 2101 Constitution (1) Less than 10,000 organisms/gram Ave. NW., Washington, DC 20055 (Inter- by aerobic plate count. net address http://www.nap.edu), or (2) Less than 10 yeasts and molds/ may be examined at the Center for gram. Food Safety and Applied Nutrition’s (3) Negative for Salmonella, E. coli, Library, Food and Drug Administra- coagulase positive Staphylococci, Clos- tion, 5100 Paint Branch Pkwy., College tridium perfringens, Clostridium botu- Park, MD 20740, or at the Office of the linum, or any other recognized micro- Federal Register, 800 North Capitol St. bial pathogen or any harmful microbial NW., suite 700, Washington, DC. toxin. (3) The whey protein concentrate (d) The ingredient is used as a fla- shall be derived from milk that has voring agent and adjuvant as defined in been pasteurized, or the whey protein § 170.3(o)(12) of this chapter at a level concentrate shall be subjected to pas- not to exceed 5 percent in food. teurization techniques or its equiva- (e) This regulation is issued prior to lent before use in food. general evaluation of use of this ingredient in order to affirm as GRAS the (c) The whey protein concentrate specific use named. may be used in food in accordance with good manufacturing practice as indi- § 184.1984 Zein. cated in § 184.1(b)(1). (a) Zein (CAS Reg. No. 9010–66–6) is (d) The percent of protein present on one of the components of corn gluten. a dry product basis, i.e., ‘‘whey protein It is produced commercially by extrac- concentrate (ll% protein),’’ shall be tion from corn gluten with alkaline declared on the label of the package aqueous isopropyl alcohol containing sold to food manufacturers. The per- sodium hydroxide. The extract is then cent of protein may be declared in 5- cooled, which causes the zein to pre- percent increments, expressed as a cipitate. multiple of 5, not greater than the ac- (b) FDA is developing food-grade tual percentage of protein in the prod- specifications for zein in cooperation uct, or as an actual percentage pro- with the National Academy of vided that an analysis of the product Sciences. In the interim, the igredient on which the actual percentage is must be of a purity suitable for its in- based is supplied to the food manufac- tended use. turer. (c) In accordance with § 184.1(b)(1), (e) The presence of whey protein con- the ingredient is used in food with no centrate in a finished food product limitation other than current good manufacturing practice. The affirma- shall be listed as ‘‘whey protein con- tion of this ingredient as generally rec- centrate’’. ognized as safe (GRAS) as a direct [46 FR 44441, Sept. 4, 1981, as amended at 54 human food ingredient is based upon FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, the following current good manufac- 1999] turing practice conditions of use:

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(1) The ingredient is used as a sur- (2) The ingredient is used at levels face-finishing agent as defined in not to exceed current good manufac- § 170.3(o)(30) of this chapter. turing practice. (2) The ingredient is used in food at [60 FR 54193, Oct. 20, 1995] levels not to exceed current good manufacturing practice. PART 186—INDIRECT FOOD SUB- (d) Prior sanctions for this ingredient different from the uses established in STANCES AFFIRMED AS GEN- this section do not exist or have been ERALLY RECOGNIZED AS SAFE waived. Subpart A—General Provisions [50 FR 8999, Mar. 6, 1985] Sec. § 184.1985 Aminopeptidase enzyme 186.1 Substances added indirectly to human preparation derived from food affirmed as generally recognized as lactococcus lactis. safe (GRAS). (a) Aminopeptidase enzyme prepara- Subpart B—Listing of Specific Substances tion is derived from the nonpathogenic Affirmed as GRAS and nontoxicogenic bacterium 186.1093 Sulfamic acid. Lactococcus lactis (previously named 186.1256 Clay (kaolin). Streptococcus lactis). The preparation 186.1275 Dextrans. contains the enzyme aminopeptidase 186.1300 Ferric oxide. (CAS Reg. No. 9031–94–1; EC 3.4.11.1) and 186.1316 Formic acid. other peptidases that hydrolyze milk 186.1374 Iron oxides. proteins. The preparation is produced 186.1551 Hydrogenated fish oil. by pure culture fermentation. 186.1555 Japan wax. 186.1557 Tall oil. (b) The ingredient meets the speci- 186.1673 Pulp. fications for enzyme preparations in 186.1750 Sodium chlorite. the Food Chemicals Codex, 3d ed. (1981), 186.1756 Sodium formate. pp. 107–110, which are incorporated by 186.1770 Sodium oleate. reference in accordance with 5 U.S.C. 186.1771 Sodium palmitate. 552(a) and 1 CFR part 51. Copies are 186.1797 Sodium sulfate. available from the National Academy 186.1839 Sorbose. Press, 2101 Constitution Ave. NW., AUTHORITY: 21 U.S.C. 321, 342, 348, 371. Washington, DC 20418, or may be exam- SOURCE: 42 FR 14658, Mar. 15, 1977, unless ined at the Division of Petition Control otherwise noted. (HFS–215), Center for Food Safety and Applied Nutrition, Food and Drug Ad- Subpart A—General Provisions ministration, 1110 Vermont Ave. NW., suite 1200, Washington, DC, or at the § 186.1 Substances added indirectly to Office of the Federal Register, 800 human food affirmed as generally North Capitol St. NW., suite 700, Wash- recognized as safe (GRAS). ington, DC. (a) The indirect human food ingredi- (c) In accordance with § 184.1(b)(1), ents listed in this part have been re- the ingredient is used in food with no viewed by the Food and Drug Adminis- limitations other than current good tration and determined to be generally manufacturing practice. The affirma- recognized as safe (GRAS) for the pur- tion of this ingredient as generally rec- poses and under the conditions pre- ognized as safe as a direct human food scribed, providing they comply with ingredient is based upon the following the purity specifications listed in this current good manufacturing practice part or, in the absence of purity speci- conditions of use: fications, are of a purity suitable for (1) The ingredient is used as an en- their intended use in accordance with zyme, as defined in § 170.3(o)(9) of this § 170.30(h)(1) of this chapter. Certain in- chapter, as an optional ingredient for gredients in this part may also be used flavor development in the manufacture in food-contact surfaces in accordance of cheddar cheese, in accordance with with parts 174, 175, 176, 177, 178 or § 133.113 of this chapter, and in the § 179.45 of this chapter. Ingredients af- preparation of protein hydrolysates. firmed as GRAS for direct use in part

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184 of this chapter are also GRAS as in- mit a GRAS petition in accordance direct human food ingredients in ac- with § 170.35 of this chapter. cordance with § 184.1(a) of this chapter. (2) If the ingredient is affirmed as (b) The regulations in this part do GRAS with specific limitation(s), it not authorize direct addition of any shall be used in food-contact surfaces food ingredient to a food. They author- only within such limitation(s), includ- ize only the use of these ingredients as ing the category of food-contact sur- indirect ingredients of food, through face(s), the functional use(s) of the in- migration from their immediate wrap- gredient, and the level(s) of use. Any per, container, or other food-contact use of such an ingredient not in full surface. Any ingredient affirmed as compliance with each such established GRAS in this part shall be used in ac- limitation shall require a food additive cordance with current good manufac- regulation. turing practice. For the purpose of this (3) If the ingredient is affirmed as part, current good manufacturing prac- GRAS for a specific use, prior to gen- tice includes the requirements that an eral evaluation of use of the ingredient, indirect human food ingredient be of a other uses may also be GRAS. purity suitable for its intended use, (c) The listing of a food ingredient in and that it be used at a level no higher this part does not authorize the use of than reasonably required to achieve its such substance for the purpose of add- intended technical effect in the food- ing the ingredient to the food through contact article. extraction from the food-contact sur- (1) If the ingredient is affirmed as face. GRAS with no limitations on its conditions of use other than current good (d) The listing of a food ingredient in manufacturing practice, it shall be re- this part does not authorize the use of garded as GRAS if its conditions of use such substance in a manner that may are consistent with the requirements of lead to deception to the consumer or to paragraphs (b), (c), and (d) of this sec- any other violation of the Federal tion. When the Food and Drug Admin- Food, Drug, and Cosmetic Act (the istration (FDA) determines that it is Act). appropriate, the agency will describe (e) If the Commissioner of Food and one or more current good manufac- Drugs is aware of any prior sanction turing practice conditions of use in the for use of an ingredient under condi- regulation that affirms the GRAS sta- tions different from those proposed to tus of the indirect ingredient. For ex- be affirmed as GRAS, he will concur- ample, when the safety of an ingredient rently propose a separate regulation has been evaluated on the basis of lim- covering such use of the ingredient ited conditions of use, the agency will under part 181 of this chapter. If the describe in the regulation that affirms Commissioner is unaware of any such the GRAS status of the indirect ingre- applicable prior sanction, the proposed dient, one or more of these limited con- regulation will so state and will re- ditions of use, which may include the quire any person who intends to assert category of food-contact surface(s), or rely on such sanction to submit technical effect(s) or functional use(s) proof of its existence. Any regulation of the indirect ingredient, and the promulgated pursuant to this section level(s) of use. If the ingredient is used constitutes a determination that ex- under conditions that are significantly cluded uses would result in adultera- different from those described in the tion of the food in violation of section regulation, such use of a substance 402 of the Act, and the failure of any may not be GRAS. In such a case, a person to come forward with proof of manufacturer may not rely on the reg- such an applicable prior sanction in re- ulation as authorizing that use but sponse to the proposal will constitute a shall independently establish that the waiver of the right to assert or rely on use is GRAS or shall use the ingredient such sanction at any later time. The in accordance with a food additive reg- notice will also constitute a proposal ulation. Persons seeking FDA approval to establish a regulation under part 181 of an independent determination that a of this chapter, incorporating the same use of an ingredient is GRAS may sub- provisions, in the event that such a

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regulation is determined to be appro- (1) The ingredient is used in the man- priate as a result of submission of proof ufacture of paper and paperboard that of such an applicable prior sanction in contact food. response to the proposal. (2) The ingredient is used at levels not to exceed current good manufac- [42 FR 14658, Mar. 15, 1977, as amended at 48 FR 48457, 48459, Oct. 19, 1983] turing practice. (c) Prior sanctions for this ingredient different from the uses established in Subpart B—Listing of Specific this regulation do not exist or have Substances Affirmed as GRAS been waived. § 186.1093 Sulfamic acid. [47 FR 43367, Oct. 1, 1982]

(a) Sulfamic acid (H3NO3S, CAS Reg. § 186.1275 Dextrans. No. 5329–14–6) is a white crystalline (a) Dextrans (CAS Reg. No. 9004–54–0) solid manufactured from urea, sulfur are high molecular weight trioxide, and sulfuric acid. It is soluble polysaccharides produced by bacterial and highly ionized in water. fermentation of sucrose. Commercially (b) In accordance with § 186.1(b)(1), available dextrans are synthesized the ingredient is used as an indirect from sucrose by Leuconostoc food ingredient with no limitations mesenteroides strain NRRL B–512(F). other than current good manufacturing Partial depolymerization and purifi- practice. The affirmation of this ingre- cation of the fermented mixture shall dient as generally recognized as safe produce a product that is free of viable (GRAS) as an indirect human food in- microorganisms. gredient is based upon the current good (b) The ingredient is used or intended manufacturing practice of using this for use as a constituent of food-contact ingredient in the manufacture of paper surfaces. and paperboard that contact food. (c) The ingredient is used at levels (c) Prior sanctions for this ingredient not to exceed good manufacturing different from the uses established in practice. this section do not exist or have been (d) Prior sanctions for this ingredient waived. different from the uses established in [47 FR 29954, July 9, 1982] this section do not exist or have been waived. § 186.1256 Clay (kaolin). [43 FR 29288, July 7, 1978, as amended at 48 (a) Clay (kaolin) Al2O3.2SiO2.nH2O, Cas FR 48457, Oct. 19, 1983] Reg. No. 1332–58–7) consists of hydrated aluminum silicate. The commercial § 186.1300 Ferric oxide. products of clay (kaolin) contain vary- (a) Ferric oxide (iron (III) oxide, ing quantities of alkalies and alkaline Fe2O3, CAS Reg. No. 1309–37–1) occurs earths. Clay (kaolin) is a white to yel- naturally as the mineral hematite. It lowish or grayish fine powder. There may be prepared synthetically by heat- are at least three different minerals, ing brown iron hydroxide oxide. The kaolinite, dickite, and nacrite, classi- product is red-brown to black trigonal fied as kaolin. Kaolinite or china clay crystals. is whiter, less contaminated with ex- (b) In accordance with § 186.1(b)(1), traneous minerals, and less plastic in the ingredient is used as an indirect water. human food ingredient with no limita- (b) In accordance with § 186.1(b)(1), tion other than current good manufac- the ingredient is used as an indirect turing practice. The affirmation of this human food ingredient with no limita- ingredient as generally recognized as tion other than current good manufac- safe (GRAS) as an indirect human food turing practice. The affirmation of this ingredient is based upon the following ingredient as generally recognized as current good manufacturing practice safe (GRAS) as an indirect human food conditions of use: ingredient is based upon the following (1) The ingredient is used as a con- current good manufacturing practice stituent of paper and paperboard used conditions of use: for food packaging.

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(2) The ingredient is used at levels this section do not exist or have been not to exceed current good manufac- waived. turing practice. [53 FR 16867, May 12, 1988; 53 FR 20939, June (c) Prior sanctions for this ingredient 7, 1988] different from the uses established in this section do not exist or have been § 186.1551 Hydrogenated fish oil. waived. (a) Hydrogenated fish oil (CAS Reg. [53 FR 16867, May 12, 1988; 53 FR 20939, June No. 91078–95–4) is a class of oils pro- 7, 1988] duced by partial hydrogenation of oils expressed from fish, primarily menha- § 186.1316 Formic acid. den, and secondarily herring or tuna. Hydrogenation of fish oils uses cata- (a) Formic acid (CH2O2, CAS Reg. No. 64–18–6) is also referred to as methanoic lysts composed of either elemental acid or hydrogen carboxylic acid. It oc- nickel, elemental copper, or a mixture curs naturally in some insects and is of these elements. The crude hydro- contained in the free acid state in a genated fish oil is further processed by number of plants. Formic acid is pre- alkali refining, bleaching, and deodori- pared by the reaction of sodium for- zation by steam stripping. mate with sulfuric acid and is isolated (b) Hydrogenation of fish oils results by distillation. in a final product with a melting point (b) Formic acid is used as a con- greater than 32 °C as determined by stituent of paper and paperboard used Section Cc 1–25, Official and Tentative for food packaging. Methods of the American Oil Chemists’ (c) The ingredient is used at levels Society method (reapproved 1973) or not to exceed good manufacturing equivalent. The product has an approx- practice in accordance with § 186.1(b)(1). imate fatty acid composition of 30 to 45 percent saturated fatty acids, 40 to 55 (d) Prior sanctions for formic acid percent monoenoic fatty acids, 7 to 15 different from the uses established in percent dienoic fatty acids, 3 to 10 per- this section do not exist or have been cent trienoic fatty acids, and less than waived. 2 percent tetraenoic or higher [45 FR 22915, Apr. 4, 1980] polyenoic fatty acids. The approximate percentages of total fatty acids by car- § 186.1374 Iron oxides. bon chain length are 15 to 30 percent (a) Iron oxides (oxides of iron, CAS each of C16, C18, C20, C22, less than 10 Reg. No. 97705–33–85) are undefined mix- percent C14 or lower carbon chain tures of iron (II) oxide (CAS Reg. No. length, and less than 1 percent C24 or 1345–25–1, black cubic crystals) and iron higher carbon chain length fatty acids. (III) oxide (CAS Reg. No. 1309–37–1, red- (c) The ingredient is used as a con- brown to black trigonal crystals). stituent of cotton and cotton fabrics (b) In accordance with § 186.1(b)(1), used for dry food packaging. the ingredient is used as an indirect (d) The ingredient is used at levels human food ingredient with no limita- not to exceed good manufacturing tion other than current good manufac- practice in accordance with § 186.1(b)(1). turing practice. The affirmation of this (e) Prior sanctions for this ingredient ingredient as generally recognized as different from the use established in safe (GRAS) as an indirect human food this section do not exist or have been ingredient is based upon the following waived. current good manufacturing practice [44 FR 28323, May 15, 1979, as amended at 49 conditions of use: FR 5614, Feb. 14. 1984; 58 FR 17099, Apr. 1, (1) The ingredient is used as a con- 1993] stituent of paper and paperboard used for food packaging. § 186.1555 Japan wax. (2) The ingredient is used at levels (a) Japan wax (CAS Reg. No. 8001–39– not to exceed current good manufac- 6), also known as Japan tallow or turing practice. sumac wax, is a pale yellow vegetable (c) Prior sanctions for this ingredient tallow, containing glycerides of the different from the uses established in C19-C23 dibasic acids and a high content 570

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of tripalmitin. It is prepared from the part 181 of this chapter, do not exist or mesocarp by hot pressing of immature have been waived. fruits of the oriental sumac, Rhus [51 FR 16830, May 7, 1986] succedanea (Japan, Taiwan, and Indo- China), R. vernicifera (Japan), and R. § 186.1673 Pulp. trichocarpa (China, Indo-China, India, and Japan). Japan wax is soluble in hot (a) Pulp is the soft, spongy pith in- alcohol, benzene, and naphtha, and inside the stem of a plant such as wood, soluble in water and in cold alcohol. straw, sugarcane, or other natural (b) In accordance with paragraph plant sources. (b)(1) of this section, the ingredient is (b) The ingredient is used or intended used as an indirect human food ingre- for use as a constituent of food pack- dient with no limitation other than aging containers. current good manufacturing practice. (c) The ingredient is used in paper The affirmation of this ingredient as and paperboard made by conventional generally recognized as safe (GRAS) as paper-making processes at levels not to an indirect human food ingredient is exceed good manufacturing practice. based on the following current good (d) Prior sanctions for this ingredient manufacturing practice conditions of different from the uses established in use: this section do not exist or have been (1) The ingredient is used as a con- waived. stituent of cotton and cotton fabrics § 186.1750 Sodium chlorite. used for dry food packaging. (2) The ingredient is used at levels (a) Sodium chlorite (NaCLO2, CAS not to exceed current good manufac- Reg. No. 7758–19–2) exists as slightly turing practice. hygroscopic white crystals or flakes. It (c) Prior sanctions for this ingredient is manufactured by passing chlorine di- different from the uses established in oxide into a solution of sodium hydrox- this section do not exist or have been ide and hydrogen peroxide. waived. (b) the ingredient is used at levels from 125 to 250 parts per million as a [60 FR 62208, Dec. 5, 1995] slimicide in the manufacture of paper and paperboard that contact food. § 186.1557 Tall oil. [45 FR 16470, Mar. 14, 1980] (a) Tall oil (CAS Reg. No. 8002–26–4) is essentially the sap of the pine tree. It § 186.1756 Sodium formate. is obtained commercially from the (a) Sodium formate (CHNaO , CAS waste liquors of pinewood pulp mills 2 Reg. No. 141–53–7) is the sodium salt of and consists mainly of tall oil resin formic acid. It is produced by the reac- acids and tall oil fatty acids. tion of carbon monoxide with sodium (b) In accordance with § 186.1(b)(1), hydroxide. the ingredient is used as an indirect (b) The ingredient is used as a con- human food ingredient with no limita- stituent of paper and paperboard used tion other than current good manufac- for food packaging. turing practice. The affirmation of this (c) The ingredient is used at levels ingredient as generally recognized as not to exceed good manufacturing safe (GRAS) as an indirect human food practice in accordance with § 186.1(b)(1). ingredient is based on the following (d) Prior sanctions for sodium for- current good manufacturing practice mate different from the uses estab- conditions of use: lished in this section do not exist or (1) The ingredient is used as a con- have been waived. stituent of cotton and cotton fabrics used for dry food packaging. [45 FR 22915, Apr. 4, 1980] (2) The ingredient is used at levels not to exceed current good manufac- § 186.1770 Sodium oleate. turing practice. (a) Sodium oleate (C18H33O2Na, CAS (c) Prior sanctions for this ingredient Reg. No. 143–19–1) is the sodium salt of different from the uses established in oleic acid (cis-9-octadecenoic acid). It this section, or from those listed in exists as a white to yellowish powder

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with a slight tallow-like odor. Com- § 186.1839 Sorbose. mercially, sodium oleate is made by mixing and heating flaked sodium hy- (a) Sorbose (L-sorbose, sorbinose) droxide and oleic acid. (C6H12O6, CAS Reg. No. 87–79–6) is an (b) In accordance with § 186.1(b)(1), orthorhombic, bisphenoidal crystalline the ingredient is used as a constituent ketohexose. It was originally identifed of paper and paperboard for food pack- in the juice of mature berries from the aging and as a component of lubricants mountain ash (Sorbus aucuparia) where with incidental food contact in accord- it occurs as the result of microbial oxi- ance with § 178.3570 of this chapter, dation of sorbitol. It also occurs natu- with no limitation other than current rally in other plants. Sorbose can be good manufacturing practice. synthesized by the catalytic hydro- (c) Prior sanctions for this ingredient genation of glucose to D-sorbitol. The different from the uses established in resulting sorbitol can be oxidized by this section do not exist or have been Acetobacter xylinum or by Acetobacter waived. suboxydans. [51 FR 39372, Oct. 28, 1986] (b) The ingredient is used or intended for indirect food use as a constituent of § 186.1771 Sodium palmitate. cotton, cotton fabrics, paper, and pa- (a) Sodium palmitate (C16H31O2Na, perboard in contact with dry food. CAS Reg. No. 408–35–5) is the sodium (c) The ingredient migrates to food at salt of palmitic acid (hexadecanoic levels not to exceed good manufac- acid). It exists as a white to yellow turing practice. powder. Commercially, sodium (d) Prior sanctions for this ingredient palmitate is made by mixing and heat- different from the uses established in ing flaked sodium hydroxide and pal- this section do not exist or have been mitic acid. waived. (b) In accordance with § 186.1(b)(1), the ingredient is used as a constituent [43 FR 11698, Mar. 21, 1978, as amended at 48 of paper and paperboard for food pack- FR 48457, Oct. 19, 1983] aging with no limitation other than current good manufacturing practice. PART 189—SUBSTANCES PROHIB- (c) Prior sanctions for this ingredient different from the uses established in ITED FROM USE IN HUMAN this section do not exist or have been FOOD waived. Subpart A—General Provisions [51 FR 39372, Oct. 28, 1986] Sec. § 186.1797 Sodium sulfate. 189.1 Substances prohibited from use in

(a) Sodium sulfate (Na2SO4, CAS Reg. human food. No. 7757–82–6), also known as Glauber’s salt, occurs naturally and exists as Subpart B—Substances Generally Prohib- colorless crystals or as a fine, white ited From Direct Addition or Use as crystalline powder. It is prepared by Human Food the neutralization of sulfuric acid with 189.110 Calamus and its derivatives. sodium hydroxide. 189.113 Cinnamyl anthranilate. (b) The ingredient is used as a con- 189.120 Cobaltous salts and its derivatives. stituent of paper and paperboard used 189.130 Coumarin. for food packaging, and cotton and cot- 189.135 Cyclamate and its derivatives. ton fabric used for dry food packaging. 189.140 Diethylpyrocarbonate (DEPC). (c) The ingredient is used at levels 189.145 Dulcin. not to exceed good manufacturing 189.155 Monochloroacetic acid. practice in accordance with § 186.1(b)(1). 189.165 Nordihydroguaiaretic acid (NDGA). (d) Prior sanctions for this ingredient 189.175 P–4000. different from the uses established in 189.180 Safrole. this section do not exist or have been 189.190 Thiourea. waived. [45 FR 6086, Jan. 25, 1980]

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189.191 Chlorofluorocarbon propellants. Subpart B—Substances Generally Subpart C—Substances Prohibited From In- Prohibited From Direct Addi- direct Addition to Human Food tion or Use as Human Food Through Food-Contact Surfaces § 189.110 Calamus and its derivatives. 189.220 Flectol H. 189.240 Lead solders. (a) Calamus is the dried rhizome of 189.250 Mercaptoimidazoline and 2- Acorus calamus L. It has been used as a mercaptoimidazoline. flavoring compound, especially as the 189.280 4,4′-Methylenebis (2-chloroanaline). oil or extract. 189.300 Hydrogenated 4,4′-isopropylidene- diphenolphosphite ester resins. (b) Food containing any added 189.301 Tin–coated lead foil capsules for calamus, oil of calamus, or extract of wine bottles. calamus is deemed to be adulterated in AUTHORITY: 21 U.S.C. 321, 342, 348, 371. violation of the act based upon an order published in the FEDERAL REG- SOURCE: 42 FR 14659, Mar. 15, 1977, unless otherwise noted. ISTER of May 9, 1968 (33 FR 6967). (c) The analytical method used for EDITORIAL NOTE: Nomenclature changes to detecting oil of calamus ( -asarone) is part 189 appear at 61 FR 14482, Apr. 2, 1996, b and 66 FR 56035, Nov. 6, 2001. in the ‘‘Journal of the Association of Official Analytical Chemists,’’ Volume Subpart A—General Provisions 56, (Number 5), pages 1281 to 1283, Sep- tember 1973, which is incorporated by § 189.1 Substances prohibited from use reference. Copies are available from in human food. the Association of Official Analytical (a) The food ingredients listed in this Chemists International, 481 North section have been prohibited from use Frederick Ave., suite 500, Gaithersburg, in human food by the Food and Drug MD 20877–2504, also from the Division of Administration because of a deter- Food and Color Additives, Center for mination that they present a potential Food Safety and Applied Nutrition risk to the public health or have not (HFS–200), Food and Drug Administra- been shown by adequate scientific data tion, 5100 Paint Branch Pkwy., College to be safe for use in human food. Use of Park, MD 20740, or available for inspec- any of these substances in violation of tion at the Office of the Federal Reg- this section causes the food involved to ister, 800 North Capitol Street, NW., be adulterated in violation of the act. suite 700, Washington, DC 20408. (b) This section includes only a partial list of substances prohibited from [42 FR 14659, Mar. 15, 1977, as amended at 47 use in human food, for easy reference FR 11855, Mar. 19, 1982; 54 FR 24899, June 12, purposes, and is not a complete list of 1989] substances that may not lawfully be used in human food. No substance may § 189.113 Cinnamyl anthranilate. be used in human food unless it meets (a) The food additive cinnamyl an- all applicable requirements of the act. thranilate (C16H15NO2, CAS Reg. No. 87– (c) The Commissioner of Food and 29–6) is the ester of cinnamyl alcohol Drugs, either on his own initiative or and anthranilic acid. Cinnamyl an- on behalf of any interested person who thranilate is a synthetic chemical that has submitted a petition, may publish has not been identified in natural prod- a proposal to establish, amend, or re- ucts at levels detectable by available peal a regulation under this section on methodology. It has been used as a fla- the basis of new scientific evaluation voring agent in food. or information. Any such petition shall include an adequate scientific basis to (b) Food containing any added support the petition, pursuant to part cinnamyl anthranilate is deemed to be 10 of this chapter, and will be published adulterated in violation of the act for comment if it contains reasonable based upon an order published in the grounds. FEDERAL REGISTER of October 23, 1985. [42 FR 14659, Mar. 15, 1977, as amended at 54 [50 FR 42932, Oct. 23, 1985] FR 24899, June 12, 1989]

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§ 189.120 Cobaltous salts and its de- (b) Food containing any added or derivatives. tectable level of cyclamate is deemed (a) Cobaltous salts are the chemicals, to be adulterated in violation of the act based upon an order published in CoC4H6O4, CoCl2, and CoSO4.They have been used in fermented malt beverages the FEDERAL REGISTER of October 21, as a foam stabilizer and to prevent 1969 (34 FR 17063). (c) The analytical methods used for ‘‘gushing.’’ detecting cyclamate in food are in sec- (b) Food containing any added cobal- tions 20.162–20.172 of the ‘‘Official Meth- tous salts is deemed to be adulterated ods of Analysis of the Association of in violation of the act based upon an Official Analytical Chemists,’’ 13th Ed. order published in the FEDERAL REG- (1980), which is incorporated by ref- ISTER of August 12, 1966 (31 FR 8788). erence. Copies may be obtained from the Association of Official Analytical § 189.130 Coumarin. Chemists International, 481 North (a) Coumarin is the chemical 1,2- Frederick Ave., suite 500, Gaithersburg, benzopyrone, C9H6O2. It is found in MD 20877–2504, or may be examined at tonka beans and extract of tonka the Office of the Federal Register, 800 beans, among other natural sources, North Capitol Street, NW., suite 700, and is also synthesized. It has been Washington, DC 20408. used as a flavoring compound. (b) Food containing any added cou- [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, marin as such or as a constituent of 1989] tonka beans or tonka extract is deemed to be adulterated under the act, based § 189.140 Diethylpyrocarbonate upon an order published in the FED- (DEPC). ERAL REGISTER of March 5, 1954 (19 FR (a) Diethylpyrocarbonate is the 1239). chemical pyrocarbonic acid diethyl (c) The analytical methods used for ester, C6H10O5. It is a synthetic chem- detecting coumarin in food are in sec- ical not found in natural products at tions 19.016–19.024 of the ‘‘Official Meth- levels detectable by available method- ods of Analysis of the Association of ology and has been used as a ferment Official Analytical Chemists,’’ 13th Ed. inhibitor in alcoholic and nonalcoholic (1980), which is incorporated by ref- beverages. erence. Copies may be obtained from (b) Food containing any added or de- the Association of Official Analytical tectable level of DEPC is deemed to be Chemists International, 481 North adulterated in violation of the act Frederick Ave., suite 500, Gaithersburg, based upon an order published in the MD 20877–2504, or may be examined at FEDERAL REGISTER of August 2, 1972 (37 the Office of the Federal Register, 800 FR 15426). North Capitol Street, NW., suite 700, Washington, DC 20408. § 189.145 Dulcin. [42 FR 14659, Mar. 15, 1977, as amended at 49 (a) Dulcin is the chemical 4- FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, ethoxyphenylurea, C9H12N2O2. It is a 1989] synthetic chemical having a sweet taste about 250 times that of sucrose, is § 189.135 Cyclamate and its deriva- not found in natural products at levels tives. detectable by the official methodology, (a) Calcium, sodium, magnesium and and has been proposed for use as an ar- potassium salts of cyclohexane sul- tificial sweetener. famic acid, (C6H12NO3S)2Ca, (b) Food containing any added or de- (C6H12NO3S)Na, (C6H12NO3S)2Mg, and tectable level of dulcin is deemed to be (C6H12NO3S)K. Cyclamates are syn- adulterated in violation of the act, thetic chemicals having a sweet taste based upon an order published in the 30 to 40 times that of sucrose, are not FEDERAL REGISTER of January 19, 1950 found in natural products at levels de- (15 FR 321). tectable by the official methodology, (c) The analytical methods used for and have been used as artificial sweet- detecting dulcin in food are in sections eners. 20.173–20.176 of the ‘‘Official Methods of

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Analysis of the Association of Official of certain plants. The commercial Analytical Chemists,’’ 13th Ed. (1980), product, which is synthesized, has been which is incorporated by reference. used as an antioxidant in foods. Copies may be obtained from the Asso- (b) Food containing any added NDGA ciation of Official Analytical Chemists is deemed to be adulterated in viola- International, 481 North Frederick tion of the act based upon an order Ave., suite 500, Gaithersburg, MD 20877– published in the FEDERAL REGISTER of 2504, or may be examined at the Office April 11, 1968 (33 FR 5619). of the Federal Register, 800 North Cap- (c) The analytical method used for itol Street, NW., suite 700, Washington, detecting NDGA in food is in section DC 20408. 20.008(b) of the ‘‘Official Methods of [42 FR 14659, Mar. 15, 1977, as amended at 49 Analysis of the Association of Official FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, Analytical Chemists International,’’ 1989] 13th Ed. (1980), which is incorporated by reference. Copies may be obtained § 189.155 Monochloroacetic acid. from the Association of Official Ana- (a) Monochloroacetic acid is the lytical Chemists International, 481 chemical chloroacetic acid, C2H3C1O2. North Frederick Ave., suite 500, Gai- It is a synthetic chemical not found in thersburg, MD 20877–2504, or may be ex- natural products, and has been pro- amined at the Office of the Federal posed as a preservative in alcoholic and Register, 800 North Capitol Street, nonalcoholic beverages. NW., suite 700, Washington, DC 20408. Monochloroacetic acid is permitted in food package adhesives with an accept- [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, ed migration level up to 10 parts per 1989] billion (ppb) under § 175.105 of this chapter. The official methods do not detect § 189.175 P–4000. monochloroacetic acid at the 10 ppb level. (a) P–4000 is the chemical 5-nitro-2-n- (b) Food containing any added or de- propoxyaniline, C9H12N2O3. It is a syn- tectable level of monochloroacetic acid thetic chemical having a sweet taste is deemed to be adulterated in viola- about 4000 times that of sucrose, is not tion of the act based upon trade cor- found in natural products at levels de- respondence dated December 29, 1941 tectable by the official methodology, (TC–377). and has been proposed for use as an ar- (c) The analytical methods used for tificial sweetener. detecting monochloroacetic acid in (b) Food containing any added or de- food are in sections 20.067–20.072 of the tectable level of P–4000 is deemed to be ‘‘Official Methods of Analysis of the adulterated in violation of the act Association of Official Analytical based upon an order published in the Chemists,’’ 13th Ed. (1980), which is in- FEDERAL REGISTER of January 19, 1950 corporated by reference. Copies may be (15 FR 321). obtained from the Association of Offi- (c) The analytical methods used for cial Analytical Chemists International, detecting P–4000 in food are in sections 481 North Frederick Ave., suite 500, 20.177–20.181 of the ‘‘Official Methods of Gaithersburg, MD 20877–2504, or may be Analysis of the Association of Official examined at the Office of the Federal Analytical Chemists,’’ 13th Ed. (1980), Register, 800 North Capitol Street, which is incorporated by reference. NW., suite 700, Washington, DC 20408. Copies may be obtained from the Asso- ciation of Official Analytical Chemists [42 FR 14659, Mar. 15, 1977, as amended at 49 International, 481 North Frederick FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989] Ave., suite 500, Gaithersburg, MD 20877– 2504, or may be examined at the Office § 189.165 Nordihydroguaiaretic acid of the Federal Register, 800 North Cap- (NDGA). itol Street, NW., suite 700, Washington, (a) Nordihydroguaiaretic acid is the DC 20408. chemical 4,4′-(2,3-dimethyltetrame- [42 FR 14659, Mar. 15, 1977, as amended at 49 thylene) dipyrocatechol, C18H22O4. It oc- FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, curs naturally in the resinous exudates 1989]

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§ 189.180 Safrole. which is incorporated by reference. (a) Safrole is the chemical 4-allyl-1,2- Copies may be obtained from the Asso- ciation of Official Analytical Chemists methylenedioxy-benzene, C10H10O2. It is a natural constituent of the sassafras International, 481 North Frederick plant. Oil of sassafras is about 80 per- Ave., suite 500, Gaithersburg, MD 20877– cent safrole. Isosafrole and 2504, or may be examined at the Office dihydrosafrole are derivatives of saf- of the Federal Register, 800 North Cap- role, and have been used as flavoring itol Street, NW., suite 700, Washington, compounds. DC 20408. (b) Food containing any added saf- [42 FR 14659, Mar. 15, 1977, as amended at 49 role, oil of sassafras, isosafrole, or FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, dihydrosafrole, as such, or food con- 1989] taining any safrole, oil of sassafras, isosafrole, or dihydrosafrole, e.g., sas- § 189.191 Chlorofluorocarbon propel- safras bark, which is intended solely or lants. primarily as a vehicle for imparting The use of chlorofluorocarbons in such substances to another food, e.g., human food as propellants in self-pres- sassafras tea, is deemed to be adulter- surized containers is prohibited as pro- ated in violation of the act based upon vided by § 2.125 of this chapter. an order published in the FEDERAL REGISTER of December 3, 1960 (25 FR [43 FR 11317, Mar. 17, 1978] 12412). (c) The analytical method used for Subpart C—Substances Prohibited detecting safrole, isosafrole and dihydrosafrole is in the ‘‘Journal of the From Indirect Addition to Association of Official Analytical Human Food Through Food- Chemists,’’ Volume 54 (Number 4), Contact Surfaces pages 900 to 902, July 1971, which is incorporated by reference. Copies are § 189.220 Flectol H. available from the Division of Food (a) Flectol H is the chemical 1,2- and Color Additives, Center for Food dihydro-2,2,4-trimethylquinoline, po- Safety and Applied Nutrition (HFS– lymerized, C12H15N. It is a synthetic 200), Food and Drug Administration, chemical not found in natural prod- 5100 Paint Branch Pkwy., College Park, ucts, and has been used as a component MD 20740, or available for inspection at of food packaging adhesives. the Office of the Federal Register, 800 (b) Food containing any added or de- North Capitol Street, NW., suite 700, tectable level of this substance is Washington, DC 20408. deemed to be adulterated in violation [42 FR 14659, Mar. 15, 1977, as amended at 42 of the act based upon an order pub- FR 56729, Oct. 28, 1977; 47 FR 11855, Mar. 19, lished in the FEDERAL REGISTER of 1982; 54 FR 24900, June 12, 1989] April 7, 1967 (32 FR 5675). § 189.190 Thiourea. [42 FR 14659, Mar.15, 1977, as amended at 58 (a) Thiourea is the chemical FR 17099, Apr. 1, 1993] thiocarbamide, CH4N2S. It is a synthetic chemical, is not found in natural § 189.240 Lead solders. products at levels detectable by the of- (a) Lead solders are alloys of metals ficial methodology, and has been pro- that include lead and are used in the posed as an antimycotic for use in dip- construction of metal food cans. ping citrus. (b) Food packaged in any container (b) Food containing any added or de- that makes use of lead in can solder is tectable level of thiourea is deemed to deemed to be adulterated in violation be adulterated under the act. of the Federal Food, Drug, and Cos- (c) The analytical methods used for metic Act, based upon an order pub- detecting thiourea are in sections lished in the FEDERAL REGISTER of 20.115–20.126 of the ‘‘Official Methods of June 27, 1995. Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), [60 FR 33109, June 27, 1995]

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§ 189.250 Mercaptoimidazoline and 2- § 189.301 Tin-coated lead foil capsules mercaptoimidazoline. for wine bottles. (a) Mercaptoimidazoline and 2- (a) Tin-coated lead foil is composed mercaptoimidazoline both have the of a lead foil coated on one or both molecular formula C3H6N2S. They are sides with a thin layer of tin. Tin-coat- synthetic chemicals not found in nated lead foil has been used as a capsule ural products and have been used in the (i.e., as a covering applied over the production of rubber articles that may cork and neck areas) on wine bottles to come into contact with food. prevent insect infestation, as a barrier (b) Food containing any added or de- to oxygen, and for decorative purposes. lectable levels of these substances is Information received by the Food and deemed to be adulterated in violation Drug Administration establishes that of the act based upon an order pub- the use of such a capsule on wine bot- lished in the FEDERAL REGISTER of No- tles may reasonably be expected to re- vember 30, 1973 (38 FR 33072). sult in lead becoming a component of the wine. § 189.280 4,4′-Methylenebis (2-chloroanaline). (b) The capping of any bottles of wine after February 8, 1996, with a tin-coat- ′ (a) 4,4 -Methylenebis (2- ed lead foil capsule renders the wine chloroanaline) has the molecular for- adulterated and in violation of section mula, C13H12Cl2N2. It is a synthetic 402(a)(2)(C) of the Federal Food, Drug, chemical not found in natural products and Cosmetic Act because lead from and has been used as a polyurethane the capsule, which is an unsafe food ad- curing agent and as a component of ditive within the meaning of section food packaging adhesives and poly- 409 of the act, may reasonably be ex- urethane resins. pected to become a component of the (b) Food containing any added or de- wine. tectable level of this substance is deemed to be adulterated in violation [61 FR 4820, Feb. 8, 1996] of the act based upon an order published in the FEDERAL REGISTER of De- PART 190—DIETARY SUPPLEMENTS cember 2, 1969 (34 FR 19073).

§ 189.300 Hydrogenated 4,4′-isopropyl- Subpart A [Reserved] idene-diphenolphosphite ester resins. Subpart B—New Dietary Ingredient Notification (a) Hydrogenated 4,4′-isopropylidene- diphenolphosphite ester resins are the Sec. condensation product of 1 mole of 190.6 Requirement for premarket notifica- triphenyl phosphite and 1.5 moles of tion. ′ hydrogenated 4,4 -isopropylidene- AUTHORITY: Secs. 201(ff), 301, 402, 413, 701 of diphenol such that the finished resins the Federal Food, Drug, and Cosmetic Act have a molecular weight in the range (21 U.S.C. 321(ff), 331, 342, 350b, 371). of 2,400 to 3,000. They are synthetic SOURCE: 62 FR 49891, Sept. 23, 1997, unless chemicals not found in natural prod- otherwise noted. ucts and have been used as antioxidants and as stabilizers in vinyl EDITORIAL NOTE: Nomenclature changes to chloride polymer resins when such part 190 appear at 66 FR 56035, Nov. 6, 2001. polymer resins are used in the manufacture of rigid vinyl chloride polymer Subpart A [Reserved] bottles. (b) Food containing any added or de- Subpart B—New Dietary tectable levels of these substances is Ingredient Notification deemed to be adulterated and in violation of the Federal Food, Drug, and § 190.6 Requirement for premarket no- Cosmetic Act, based upon an order pub- tification. lished in the FEDERAL REGISTER of Sep- (a) At least 75 days before intro- tember 9, 1987 (52 FR 33929). ducing or delivering for introduction [54 FR 7188, Feb. 17, 1989] into interstate commerce a dietary

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supplement that contains a new die- the new dietary supplement will rea- tary ingredient that has not been sonably be expected to be safe. Any ref- present in the food supply as an article erence to published information offered used for food in a form in which the in support of the notification shall be food has not been chemically altered, accompanied by reprints or photostatic the manufacturer or distributor of that copies of such references. If any part of supplement, or of the new dietary in- the material submitted is in a foreign gredient, shall submit to the Office of language, it shall be accompanied by Nutritional Products, Labeling and Di- an accurate and complete English etary Supplements (HFS–820), Center translation; and for Food Safety and Applied Nutrition, (5) The signature of the person des- Food and Drug Administration, 5100 ignated by the manufacturer or dis- Paint Branch Pkwy., College Park, MD tributor of the dietary supplement that 20740, information including any cita- contains a new dietary ingredient. tion to published articles that is the (c) FDA will acknowledge its receipt basis on which the manufacturer or of a notification made under section distributor has concluded that a die- 413 of the Federal Food, Drug, and Cos- tary supplement containing such die- metic Act (the act) and will notify the tary ingredient will reasonably be ex- submitter of the date of receipt of such pected to be safe. An original and two a notification. The date that the agen- copies of this notification shall be sub- cy receives the notification submitted mitted. under paragraph (a) of this section is (b) The notification required by para- the filing date for the notification. For graph (a) of this section shall include: 75 days after the filing date, the manu- (1) The name and complete address of facturer or distributor of a dietary sup- the manufacturer or distributor of the plement that contains a new dietary dietary supplement that contains a ingredient shall not introduce, or de- new dietary ingredient, or of the new liver for introduction, into interstate dietary ingredient; commerce the dietary supplement that (2) The name of the new dietary in- contains the new dietary ingredient. gredient that is the subject of the premarket notification, including the (d) If the manufacturer or distributor Latin binomial name (including the au- of a dietary supplement that contains a thor) of any herb or other botanical; new dietary ingredient, or of the new (3) A description of the dietary sup- dietary ingredient, provides additional plement or dietary supplements that information in support of the new die- contain the new dietary ingredient in- tary ingredient notification, the agen- cluding: cy will review all submissions per- (i) The level of the new dietary ingre- taining to that notification, including dient in the dietary supplement; and responses made to inquiries from the (ii) The conditions of use rec- agency, to determine whether they are ommended or suggested in the labeling substantive and whether they require of the dietary supplement, or if no con- that the 75-day period be reset. If the ditions of use are recommended or sug- agency determines that the new sub- gested in the labeling of the dietary mission is a substantive amendment, supplement, the ordinary conditions of FDA will assign a new filing date. FDA use of the supplement; will acknowledge receipt of the addi- (4) The history of use or other evi- tional information and, when applica- dence of safety establishing that the ble, notify the manufacturer of the new dietary ingredient, when used under filing date, which is the date of receipt the conditions recommended or sug- by FDA of the information that con- gested in the labeling of the dietary stitutes the substantive amendment. supplement, will reasonably be ex- (e) FDA will not disclose the exist- pected to be safe, including any cita- ence of, or the information contained tion to published articles or other evi- in, the new dietary ingredient notifica- dence that is the basis on which the tion for 90 days after the filing date of distributor or manufacturer of the die- the notification. After the 90th day, all tary supplement that contains the new information in the notification will be dietary ingredient has concluded that placed on public display, except for any

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information that is trade secret or oth- ment that contains the new dietary in- erwise confidential commercial infor- gredient is safe or is not adulterated mation. under section 402 of the act. (f) Failure of the agency to respond [62 FR 49891, Sept. 23, 1997, as amended at 66 to a notification does not constitute a FR 17359, Mar. 30, 2001] finding by the agency that the new dietary ingredient or the dietary supple- PARTS 191–199 [RESERVED]

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A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabetical list of agencies publishing in the CFR are included in the CFR Index and Finding Aids volume to the Code of Federal Regulations which is published separately and revised annually. Material Approved for Incorporation by Reference Table of CFR Titles and Chapters Alphabetical List of Agencies Appearing in the CFR List of CFR Sections Affected

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The Director of the Federal Register has approved under 5 U.S.C. 552(a) and 1 CFR Part 51 the incorporation by reference of the following publications. This list contains only those incorporations by reference effective as of the revision date of this volume. Incorporations by reference found within a regulation are effective upon the effective date of that regulation. For more information on incorporation by reference, see the preliminary pages of this volume.

21 CFR (PARTS 170 TO 199) FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR American Oil Chemist’s Society P.O. Box 5037, Station A, Champaign, IL 61820 AOCS Method Ca 5a-40, Free Fatty Acids (Reapproved 1989) ...... 184.1472 AOCS Method Ca 6b-53, Unsaponifiable Matter (Reapproved 1989) 184.1472 AOCS Method Ca 18c-91, Determination of Lead by Direct Graphite 184.1472 Furnace Atomic Absorption Spectrometry (Revised 1992). AOCS Method Cd 9–57, ‘‘Oxirane Oxygen,’’ Reapproved 1989 ...... 172.723 AOCS Method Cd 1–25, ‘‘Iodine Value of Fats and Oils Wijs Method’’ 172.723 Revised 1993. AOCS Method Cd 3-25, Saponification Value (Reapproved 1989) ...... 184.1472 AOCS Method Cd 8-53, Peroxide Value, Acetic Acid – Chloroform 184.1472 Method (Updated 1992). AOCS Method Trla-64T Titer Test ...... 178.3780(b)(2) AOCS Method Tlla-64T Saponification Value ...... 178.3780(b)(3) AOCS Method Te 3a–64 Acid Value and Free Amine Value of Fatty 173.400(b) Quaternary Ammonium Chlorides, Second Printing including additions and revisions, 1990. Official Methods and Recommended Practices of the American Oil 172.867 Chemists’ Society, 3d Edition (1985) Vol. 1, ‘‘Free Fatty Acids’’. Official Methods and Recommended Practices of the American Oil 172.867 Chemists’ Society, 4th Ed. (1989) Vol. 1, ‘‘Moisture’’. Official Methods and Recommended Practices of the American Oil 172.867 Chemists’ Society, 4th Ed. (1989) Vol. 1, ‘‘Peroxide Value’’. Recommended Practice Cd 8b-90, Peroxide Value, Acetic Acid – 184.1472 Isooctane Method (Updated 1992). Recommended Practice Cd Id-92, Iodine Value of Fats and Oils, 184.1472 Cyclohexane – Acetic Acid Method. American Society for Testing and Materials 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, Tele- phone (610) 832-9585, FAX (610) 832-9555 ASTM D 5–73 (Reapproved 1978) Standard Method of Test for Pene- 176.170(a)(5) tration of Bituminous Materials. ASTM D 36–76 Standard Test Method for Softening Point of Asphalts 176.170(a)(5) and Tar Pitches (Ring and Ball Apparatus). 583

VerDate May<04>2004 11:24 May 05, 2004 Jkt 203066 PO 00000 Frm 00003 Fmt 8187 Sfmt 8187 Y:\SGML\203066B.XXX 203066B Title 21—Food and Drugs 21 CFR (PARTS 170 TO 199)—Continued FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES—Continued 21 CFR ASTM D 86–82 Standard Method for Distillation of Petroleum Prod- 172.250(b)(3); ucts. 172.864(b)(2); 172.882(a); 178.3530(a); 178.3620(d)(1)(i); 178.3910(a)(4)(i)(a) ASTM D 88–81 Standard Method of Test for Saybolt Viscosity ...... 178.3870(f)(4); 178.3910 ASTM D 127–60 Standard Method of Test for Melting Point of Petro- 176.180(b)(2); latum and Microcrystalline Wax. 177.1200(c) ASTM D 156–82 Standard Method of Test for Saybolt Color of 178.3620(b)(1)(i); Petroluem Products (Saybolt Chromometer Method). 178.3910(a)(4)(i)(c) ASTM D 381–80 Standard Method of Test for Existent Gum in Fuels 172.882(a); 172.250; by Jet Evaporation. 178.3530(a); 178.3910(a)(4)(i)(b) and (b)(2) ASTM D 388–38 Standard Specifications for Classification of Coals 173.25(a)(2) by Rank. ASTM D 445–74 Standard Test Method for Kinematic Viscosity of 177.1430(c)(2); Transparent and Opaque Liquids (and the Calculations of Dynamic 177.1520(d)(5); Viscosity). 178.3740(b) ASTM D 445–82 Test Method for Kinematic Viscosity of Transparent 178.3740(b) Opaque Liquids (and the Calculations of Dynamic Viscosity). ASTM D 465–82 Standard Test Methods of Test for Acid Number 178.3870(f)(3) of Rosin. ASTM D 509–70 (Reapproved 1981) Standard Methods of Sampling 178.3870(f)(1) and Grading Rosin. ASTM D 566–76 (Reapproved 1982) Standard Method for Dropping 172.210; Point of Lubricating Grease. 178.3690(b)(1); 178.3770(a)(1), (b)(1), and (d)(1) ASTM D 611–82 Standard Test Methods for Aniline Point and Mixed 176.170; 177.1520(b) Aniline Point of Petroleum Products and Hydrocarbon Solvents. ASTM D 721–56T Tentative Method of Test for Oil Content of Petro- 172.615(a); leum Waxes. 175.250(b)(2) ASTM D 729–81 Standard Specifications for Vinylidene Chloride 179.45 Molding Compounds. ASTM D 938–71 (Reapproved 1980) Standard Method of Test for 172.615(a); Congealing Point of Petroleum Waxes, including Petrolatum. 175.250(b)(1) ASTM D 968–81 Standard Test Methods for Abrasion Resistance 177.1590; 177.1650 of Organic Coatings by the Falling Abrasive Tester. ASTM D 1218–82 Standard Test Method for Refractive Index and 178.2010 Refractive Dispersion of Hydrocarbon Liquids. ASTM D 1238–82 Standard Method of Measuring Flow Rates of 176.170(b)(2); Thermoplastics by Extrusion Plastometer. 177.1312(c)(2); 177.1520(d)(7); 177.1550(d)(2); 177.1570(b)(1)(iii) ASTM D 1238–82 Standard Test Method for Flow Rates of Thermo- 177.1350(b)(2) plastics by Extrusion Plastometer. ASTM D 1240–82 Standard Method of Test for Rosin Acids in Fatty 172.862(b)(2) Acids.

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VerDate May<04>2004 11:24 May 05, 2004 Jkt 203066 PO 00000 Frm 00004 Fmt 8187 Sfmt 8187 Y:\SGML\203066B.XXX 203066B Material Approved for Incorporation by Reference 21 CFR (PARTS 170 TO 199)—Continued FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES—Continued 21 CFR ASTM D 1243–79 Standard Methods of Test for Dilute Solution 175.270(b); Viscosity of Vinyl Chloride Polymers. 175.300(b)(3) (xxix); 176.170(a)(5); 177.1480(b)(1) (ii); 177.1950(c) (1)(ii); 177.1960(b) (1)(ii); 177.2460(c)(1); 177.1970(c) (1)(ii); 177.1980(c) (1)(ii); 179.45(c)(2)(iv) ASTM D 1303–55 (Reapproved 1979) Standard Method of Test for 177.1610(a) Total Chlorine in Vinyl Chloride Polymers and Copolymers. ASTM D 1353–78 Standard Test Method for Nonvolatile Matter in 172.882; 178.3530; Volatile Solvents for Use in Paint, Varnish, Lacquer, and Related 178.3910 Products. ASTM D 1386–78 Standard Test Method for Acid Number (Empirical) 178.3690(b)(2); of Synthetic and Natural Waxes. 178.3770(a)(2), (b)(2), and (d)(2) ASTM D 1387–78 Standard Test Method for Saponification Number 178.3690(b)(3); (Empirical) of Synthetic and Natural Waxes. 178.3770(a)(3), (b)(3), and (d)(3) ASTM D 1418–81 Standard Practice for Rubber and Rubber Latices— 177.2600(c)(4)(i) Nomenclature. ASTM D 1434–82 Standard Method for Determining Gas Permeability 177.1040 Characteristics of Plastic Film and Sheeting. ASTM D 1457–56T Test for Thermal Instability Index of Tetrafluoro- 177.1550(d)(3) ethylene Homopolymer. ASTM D 1492–78 Standard Test Method for Bromine Index of Aro- 177.1430(c)(3); matic Hydrocarbons by Coulometric Titration. 178.3740 ASTM D 1500–82 Standard Method of Test for ASTM Color of Petro- 178.3620(c)(1)(ii) leum Products (ASTM Color Scale). ASTM D 1505–68 (Reapproved 1979) Standard Test Method for Den- 177.1320(c)(1)(iii); sity of Plastics by the Density-Gradient Technique. 177.1570; 177.1520(d)(1); 177.1630; 177.2480(c)(3) ASTM D 1505–85 (Reapproved 1990) Standard Test Method for Den- 177.1345(b) sity of Plastics by Density-Gradient Technique. ASTM D 1525–87 Standard Test Method for Vicat Softening Tempera- 177.1345(b) ture of Plastics. ASTM D 1545–76 (Reapproved 1981) Standard Method of Test for 176.170(a)(5) Viscosity of Transparent Liquids by Bubble Time Method. ASTM D 1601–78 Standard Test Method for Dilute Solution Viscosity 177.1520(d)(9); of Ethylene Polymers. 177.1570(b)(1)(ii) ASTM D 1646–81 Standard Test Method for Rubber-Viscosity and 177.1210(b)(5); Volcanization Characteristics (Mooney Viscometer). 177.1520(d)(6) ASTM D 1646–92 Standard Test Method for Rubber—Viscosity and 177.2600(c)(4)(i) Vulcanization Characteristics (Mooney Viscometer). ASTM D 1747–62 (Reapproved 1978) Standard Test Method for Re- 178.3870(f)(2) fractive Index of Viscous Materials and Organosols at Low Shear Rates by Brookfield Viscometer.

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VerDate May<04>2004 11:24 May 05, 2004 Jkt 203066 PO 00000 Frm 00005 Fmt 8187 Sfmt 8187 Y:\SGML\203066B.XXX 203066B Title 21—Food and Drugs 21 CFR (PARTS 170 TO 199)—Continued FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES—Continued 21 CFR ASTM D 1824–66 (Reapproved 1980) Standard Test Method for Ap- 178.3870(f)(4) parent Viscosity of Plastisols and Organosols at Low Shear Rates by Brookfield Viscometer. ASTM D 1962–67 (Reapproved 1979) Saponification Value of Drying 178.2010(b) Oils, Fatty Acids, and Polymerized Fatty Acids. ASTM D 2117–62T Tentative Method of Test for Melting Point of 177.1520(d)(2)(i); Semicrystalline Polymers by the Hot Stage Microscopy Method. 177.1630(d)(4)(v) ASTM D 2133–66 Specifications for Acetal Resin Injection Molding 177.2480(c)(4) and Extrusion Materials. ASTM D 2236–70 Standard Method of Test for Dynamic Mechanical 177.1810(c)(1)(i) Properties of Plastics by Means of a Torsional Pendulum. ASTM D 2161–66 Standard Method of Conversion of Kinematic Vis- 178.3740(b) cosity to Saybolt Universal Viscosity or to Saybolt Furol Viscosity. ASTM D 2503–82 Standard Method of Test for Molecular Weight 175.300(b)(3)(xxxiii); of Hydrocarbons by Thermoelectric Measurement of Vapor Pressure. 176.170(b)(2); 177.1430(c)(1) ASTM D 2857–70 (Reapproved 1977) Standard Method of Test for 177.1560; Dilute Solution Viscosity of Polymers. 177.2210(b); 177.2440(a) ASTM Method D 3236–88, Standard Test Method for Apparent Vis- 177.1520(b) cosity of Hot Metal Adhesives and Coating Materials. ASTM D 3275–89 Standard Specification for E–CTFE–Flouroplastic 177.1380(a)(4) Molding, Extrusion, and Coating Materials. ASTM D 3418–82 Standard Test Method for Transition Temperatures 177.1520(d)(8) of Polymers by Thermal Analysis. ASTM D 3536–76 Standard Test Method for Molecular Weight Aver- 177.1990; 177.2000 ages and Molecular Weight Distribution of Polystyrene by Liquid Exclusion Chromatography (Gel Permeation Chromatography—GPC). ASTM D 3835–79 (Reapproved 1983) Standard Test Method for 177.1520(b) Rheological Properties of Thermoplastics with a Capillary Rheom- eter. ASTM E 28–67 (Reapproved 1982) Standard Test Method for Soft- 172.215; 172.280; ening Point by Ring-and-Ball Apparatus. 176.170; 177.1520(b); (d)(2)(ii); 178.3870(b)(5) ASTM E 131–61T Definition of Terms and Symbols Relating to Ab- 175.250(b)(3) sorption Spectroscopy (Revised 1961). ASTM E 169–63 (Reapproved 1981) Recommended Practices for Gen- 178.3620(d)(3) eral Techniques of Ultraviolet Quantitative Analysis. ASTM E 324–79 Standard Test Method for Relative Initial and Final 178.2010 Melting Range of Organic Chemicals. ASTM F 34–76 (Reapproved 1980) Standard Test Methods for Liquid 176.170(d)(3); Extraction of Flexible Barrier Materials. 177.1330(e)(4); 177.1360(b); 177.1670(b) AOAC International (Association of Official Analytical Chemists) 481 N. Frederick Ave., Suite 500, Gaithersburg, MD 20877-2407 Telephone: (301) 924–7077 Journal of the Association of Official Analytical Chemists Changes in Methods: ‘‘Glycyrrhizic Acid or Glycyrrhizic Acid Salts 184.1408 in Licorice’’ Vol. 65, pp. 471–472 (1982).

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VerDate May<04>2004 11:24 May 05, 2004 Jkt 203066 PO 00000 Frm 00006 Fmt 8187 Sfmt 8187 Y:\SGML\203066B.XXX 203066B Material Approved for Incorporation by Reference 21 CFR (PARTS 170 TO 199)—Continued FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES—Continued 21 CFR ‘‘Flavors and Nonalcoholic Beverages’’ Vol. 56(5) 1281–1283 (1973) 189.110(c) ‘‘Gas Chromatographic Determination of Safrole and Related Com- 189.180(c) pounds in Nonalcoholic Beverages: Collaborative’’ Vol. 54(4) 900– 902 (1971). ‘‘Gas-Solid Chromatographic Procedures for Determining Acrylo- 177.1030(c)(2); nitrile Monomer in Acrylonitrile-Containing Polymers and Food 177.1050(e)(4); Simulating Solvents’’ (Vol. 61, No. 6, pp. 1383–1388). 180.22(a) ‘‘Headspace Sampling and Gas-Solid Chromatographic Determina- 177.1040 tion of Residual Acrylonitrile in Acrylonitrile Copolymer Solutions’’ Vol. 65, No. 2, p. 270 (1981). ‘‘Oils, Fats, and Waxes’’ Vol. 50(1) 216–218 (1967) ...... 172.860(c)(3) ‘‘Oils, Fats, and Waxes’’ Vol. 51(2) 489–490 (1968) ...... 172.860(c)(3) ‘‘Spectrophotometric Measurements under Specification’’ Vol. 45, 172.878(a)(3); p. 66 (1962). 172.882(a); 178.3530(a); 178.3620(b)(1)(ii) Official Methods of Analysis, 13th Ed., 1980 ...... 172.340(b); 172.372; 172.385; 172.510; 172.860; 173.395; 176.170(d)(3); 177.2450; 178.3690; 184.1245; 184.1366; 184.1408(b)(1); 184.1979(a) and (b)(1); 184. 1979a(b)(1); 184.1979b(b)(1); 184.1979c(b)(1); 189.130; 189.135; 189.145; 189.155; 189.165; 189.175; 189.190

National Academy Press 500 Fifth Street, NW, Lockbox 285, Washington, DC 20055 Food Chemicals Codex, 3rd Ed., 1981 ...... 172.280; 172.320(b)(1); 172.345(b); 172.723; 172.800; 172.804; 172.810; 172.812; 172.841(b); 172.846; 172.852; 172.858; 172.862; 173.160; 173.165; 173.228; 173.280; 173.310; 178.1005; 180.25; 180.30; 180.37; 182.1625; 184.1005; 184.1007; 184.1009;

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589

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Food and Drug Administration, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS–200) 5100 Paint Branch Parkway, Room 1C-100, College Park, Maryland 20740 Absorptivity Methods ‘‘Determination of Softening Point (Drop Meth- 178.3610(a) od)’’ Appendix A–2 ‘‘Determination of Unsaturation of Resin 1977’’ Appendix A–3.

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VerDate May<04>2004 11:24 May 05, 2004 Jkt 203066 PO 00000 Frm 00012 Fmt 8187 Sfmt 8187 Y:\SGML\203066B.XXX 203066B Material Approved for Incorporation by Reference 21 CFR (PARTS 170 TO 199)—Continued FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES—Continued 21 CFR Acesulfame Potassium Assay ...... 172.800(b)(1) ‘‘Amide-Imide Polymer Content—Analysis of Monomer Content’’ ...... 177.2450(b)(3) ‘‘Analysis of Cycopaco Resin for Residual B-(2-Hydroxyethyl mer- 177.1020(b); capto) propionitrile’’. 177.1030(b) ‘‘Analysis for Dicholorbenzene in Ryton Polyphenylene Sulfide’’ ...... 177.2490(a)(3) Analytical Chemistry, Vol. 49, p. 1090 (1977) ‘‘Atomic Absorption 178.2650(b)(1)(ii) Spectrometric Determination of Sub-Part-Per-Million Quantities of Tin in Extracts and Biological Materials with a Graphite Furnace’’. Analytical Method for 10% Solution Viscosity of Tyril ...... 177.1040(c)(2) Analytical Method, ‘‘Determination of Free Phenol in Cyclized Rubber 176.170(b)(2) Resin’’. Analytical Methods ‘‘Determination of Abietic Acid and 178.3870(f)(6) Dehydroabietic Acid, in Rosins,’’ ‘‘Determination of Softening Point of Solid Resins,’’ ‘‘Determination of Saponification Number of Rosin Esters,’’ and ‘‘Determination of Phenolic Modification of Rosin De- rivatives’’. ‘‘Analytical Method for the Determination of Aspartame and Diketo- 172.804(c)(23)(c)(2) piperazine in Baked Goods and Baking Mixes,’’ October 8, 1992, as developed by the NutraSweet Co.. ‘‘Analytical Method of Determining the Amount of EVOH in the 177.1360 Extractive Residue of EVOH Film,’’ dated March 23, 1987. Analytical Method for Determination of Residual Methylene Chloride 177.1585(c) in Polyestercarbonate Resin, as developed by the General Electric Co., dated July 23, 1991. Analytical Methods for Specification Tests for Curdlan, 1996 ...... 172.809(b) ‘‘Method for Measuring the Ester Distribution of Sucrose Oligoesters,’’ 172.869 dated June 17, 1998 as developed by the Mitsubishi Chemical Corporation. ‘‘Method for Analyzing the Purity of Sucrose Fatty Acid Esters,’’ 172.869 dated June 17, 1998 as developed by the Mitsubishi Chemical Corporation. ‘‘Free Sucrose Method,’’ dated June 17, 1998 as developed by the 172.869 Mitsubishi Chemical Corporation. ‘‘Biomedical Test Materials Program: Analytical Methods for the Qual- 184.1472 ity Assurance of Fish Oil’’, published in the ‘‘NOAA Technical Memorandum NMFS-SEFC-211’’, F.M. Van Dolah and S.B. Gallo- way, editors, National Marine Fisheries Service, U.S. Department of Commerce. ‘‘Chlorine and Bromine—Coulmetric Method by Aminco 177.2210(b) Chloridometer’’. Colorimetric Determination of Residual Quaternary Ammonium Com- 173.400(c) pounds (Arquad HTL8) in Sugar and Sugar Solutions, June 13, 1990. ‘‘Determination of B-Dodecylmercaplopropionitrile in NR–16 Poly- 177.1050(b) mer’’. Determination of Copolymer Ratio in Vinylidene Chloride/Methyl 177.1990 Acrylate Copolymer. ‘‘Determination of Dimethyl Sulfoxide ...... 172.859 Determination of Divinylbenzene in Alcohol Extracts in Amberlite 173.65 XAD–4. ‘‘Determination of Ethyl Acetate’’ Test Method U.1, Sept. 29, 1981 172.859 Determination of Isobutyl Alcohol ...... 172.859

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VerDate May<04>2004 11:24 May 05, 2004 Jkt 203066 PO 00000 Frm 00013 Fmt 8187 Sfmt 8187 Y:\SGML\203066B.XXX 203066B Title 21—Food and Drugs 21 CFR (PARTS 170 TO 199)—Continued FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES—Continued 21 CFR ‘‘Determination of Lysolecithin Content of Enzyme-Modified Lecithin: 184.1063(6) Method I’’, dated 1985. ‘‘Determination of Melt Viscosity, Molecular Weight Distribution 177.1550(d)(2)(ii) Index and Viscosity Stability’’. Determination of Molecular Weight Distribution of Poly (Maleic Acid) 173.45(a) dated March 17, 1992. Determination of Olestra by Size Exclusion Chromatography, dated 172.867 December 19, 1995. Determination of PAH Content of Carbon Black, dated July 8, 1994, 178.3297(e) as developed by the Cabot Corporation. ‘‘Determination of Residual Acrylonitrile and Styrene Monomers Gas 177.1020(c)(2); Chromatographic Internal Standard Method’’. 177.1030(c)(2); 177.1040(c); 177.1050(c)(3) ‘‘Determination of Residual a,b-Olefinic and Trans Olefinic 177.2600(c)(4)(i) Unsaturation Levels in HNBR,’’ developed October 1, 1991 by Polysar Rubber Corp. ‘‘Determination of Residual Maleic Anhydride in Polymers by Gas 177.1820(c)(3) Chromatography’’. Determination of Residual Vinylidene Chloride and Methyl Acrylate 177.1990(c) in Vinylidene Chloride/Methyl Acrylate Copolymer Resins and Films. Determination of Sodium Chlorite: 50 ppm to 1500 ppm Concentra- 173.325 tion, September 13, 1995. Determination of Tert-Butyl Alcohol in Polypropylene ...... 177.1520 Determination of Total Acrylic in PP-MMA/BA Polymers, dated Feb- 177.1520(b) ruary 26, 1993. Determination of Weight Average and Number Average Molecular 173.310(c) Weight of 60/40 AA/AMPS (October 23, 1987). Determination of Weight Average and Number Average Molecular 173.73(a) Weight of Sodium Polyacrylate. ‘‘Differentiation of Nisin in Processed Cheese’’, British Standards Insti- 184.1538 tution, BS 4020, 1974. Exhibit 33B of the report of the NAS/NRC A Comprehensive Survey 170.3(n) and (o) of Industry on the use of Food Chemicals—GRAS, Sept. 1972. Fishers Johns Method #18 in ‘‘Semimiero Qualitative Organic Anal- 178.3780(b)(1) ysis’’ Second Ed.. Food Chemicals Codex, 2nd Ed., 1972 ...... 172.804(b) ‘‘Formaldehyde Release and Formaldehyde Analysis’’ ...... 177.2480(d)(2)(i) Gas Chromatographic Determination of PMS and PET in PPMS Basic 177.1635(c) Polymers. Gas Chromatography Method for Dimethyl Carbonate Impurity in 172.133(a)(2) Dimethyl Dicarbonate. ‘‘General Procedure for Determining Relative Viscosity of Polymers’’ 177.1630 ‘‘Guide to Specifications for General Notices, General Analytical Tech- 172.833(b) niques, Identification Tests, Test Solutions, and Other Referenced Materials,’’ Compendium of Food Additive Specifications, Adden- dum 4, Food and Agricultural Organization of the United Nations, Food and Nutrition Paper 5, Revision 2 (1991). ‘‘Hypalon Synthetic Rubber—Determination of Sulfur by Parr Bomb’’ 177.2210(b) ‘‘Infrared Spectrophotometric Determination of Polymers Extracted 177.1050(d); from Borex 210 Resin Pellets’’. 177.1480(b)(2)

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VerDate May<04>2004 11:24 May 05, 2004 Jkt 203066 PO 00000 Frm 00014 Fmt 8187 Sfmt 8187 Y:\SGML\203066B.XXX 203066B Material Approved for Incorporation by Reference 21 CFR (PARTS 170 TO 199)—Continued FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES—Continued 21 CFR Intrinsic Viscosity (IV) of Lexan Polycarbonate Resin By a Single 177.1585(c)(1) Point Method Using Dichloromethane as the Solvent, July 23, 1991. Intrinsic Viscosity Method–E–4 ‘‘Molecular Weight of Matrix Copoly- 177.1050(c)(2) mer by Solution Viscosity’’. Intrinsic Viscosity (IV) of Lexan Polycarbonate Resin by a Single 177.1585(c) Point Method Using Dichloromethane as the Solvent, as developed by the General Electric Co., dated September 20, 1985. Intrinsic Viscosity of ULTEM Polyetherimide Using Chloroform as 177.1595 a Solvent. Iodometric Method for the Determination of Available Chlorine Diox- 178.1010(c)(29); ide (50–250 ppm available Cl02), June 11, 1987. (c)(40) Japan Institute of Fats and Oils Analysis Method of Residual Ethyl 184.1259 Esters of Fatty Acids. Journal of the American Oil Chemists’ Society, Volume 52, January 184.1259 4, 1975, ‘‘Rapid Quantitative Determination of Residual Hexane in Oils by Direct Gas Chromatography’’. Low Molecular Weight Anoxomer Analysis ...... 172.105 Measurement of Fatty Acid Composition of Olestra Test Material, 172.867 dated December 19, 1995. Measurement of Relative Esther Distribution of Olestra Test Material, 172.867 dated December 19, 1995. Method ECD-A-AC-G-V-1-5, ‘‘Determination of Dilute Solution Vis- 177.1637(b)(2) cosity of Polyesters’’, dated May 31, 1988. Method for Determination of Intrinsic Viscosity of Maleic Anhydride 175.300(b)(3)(xix) Adduct of Crystalline Polypropylene. Method for Determining Residual Level of Poly(alkylacrylate) in Petro- 172.886; 177.866 leum Wax. Method for Determining Weight-Average and Number-Average Molec- 172.886;177.866 ular Weight and for Determining Alkylcrylate Monomer Content of Poly(alkylacrylate) used as Processing Aid in Manufacture of Petroleum Wax. Method for Measurement of the Stiffness of Olestra, dated December 172.867 19, 1995. Methodology for Ethylenimine Detection in Polyethylinimine ...... 173.357 Methodology for Ethylene-dichloride Detection in Polyethylenimine 173.357 Methodology for Molecular Weight Determination of 173.357 Polyethylenimine. Measurement of B-(2-Hydroxyethylmercapto) Propionitrile in Heptane 180.22(b) Food-Stimulating Solvent. Methyl Ethyl Ketone Test; Methyl Alcohol Test ...... 172.859(b)(9) Mooney Viscosity ...... 177.1520 NBS Circular 484, U.S. Dept. of Commerce, 1949 ...... 172.250(b)(3); 172.886(b); 178.3770(a)(4); 178.3910(a)(4)(iii) Non-volative Extractives Method ‘‘Determination of Non-Volative 177.1390(c)(3)(i) Chloroform Soluble Residues in Retort Pouch Water Extractives’’. Number Average Molecular Weight 2.4 ‘‘Osmometry’’ ...... 177.2470(c)(2) Plastics-Polyamides-Determination of Viscosity Number, ISO 307– 177.1500(c)(5) 1984(E).

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VerDate May<04>2004 11:24 May 05, 2004 Jkt 203066 PO 00000 Frm 00015 Fmt 8187 Sfmt 8187 Y:\SGML\203066B.XXX 203066B Title 21—Food and Drugs 21 CFR (PARTS 170 TO 199)—Continued FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES—Continued 21 CFR Phillips Petroleum Company Method VO–65R ‘‘Oxygen Flask Combus- 177.2490(a)(1) tion-Gravemetric Method For Determination of Sulfur in Organic Compounds’’ (1965). Phillips Petroleum Company Method 6936–BH ‘‘Determination of the 177.2490(a)(2) Inherent Viscosity of Polyphenylene Sulfide (1969). ‘‘Preparation of Extracts’’ ...... 177.1550(e) ‘‘Protein,’’ NAS in RDA’s, NAS Pub. No. 1694, 7th Ed., 1968 ...... 172.320(c)(1) ‘‘Qualitative Identification of Kalrez by Infrared Examination of 177.2400(c) Pyrolystate’’. Recommended Dietary Allowances, NAS Publication No. 1694, 7th 172.320(c)(1) Ed. (1968). ‘‘Extracted Acrylonitrile Monomer by Differential Pulse Polarography’’ 177.1020(c)(2); 177.1030(d)(2); 177.1040(c) ‘‘Procedure for the Determination of Molecular Weights of Acrylo- 177.1040 nitrile/Styrene Copolymers’’. Residual Methyl Acrylate and Vinylidene Chloride Monomers in 177.1990(c)(3) Saran MA/VDC Resins and Pellets by Headspace Gas Chroma- tography, March 3, 1986. ‘‘Solution Viscosity’’ ...... 177.2450(b)(2) Specifications and Criteria for Biochemical Compounds, NAS/NRC 172.320(b)(2) Pub. 3rd Ed., 1972. Specifications and Analytical Methods for Neotame, dated April 3, 172.829 2001. ‘‘Specifications for Identity and Purity of Some Antibiotics’’, WHO, 184.1538 FAO, Nutrition Report Series, No. 45A, 1969. Standard Methods for the Examination of Water and Wastewater, 173.300 18th Ed. (1992) – Method 4500-CIO2 E. Standard Test Method for Molecular Weight Averages and Molecular 177.1990 Weight Distribution of Polystyrene by Liquid Chromatography (Gel Permation Chromatography-GPC). Sucrose Fatty Acid Esters, Method of Assay ...... 172.859 Synthetic Fatty Alcohols Method ‘‘Diols in Monohydroxy Alcohol 178.3480(c) by Miniature Thin Layer Chromatography (MTLC)’’. The Determination of 3-Dimethylaminopropylamine in Food Simu- 173.25(b) lating Extracts of Ion Exchange Resins, dated February 4, 1998. The Determination of Epichlorophydrin and 1,3-Dichloro-2-Propanol 173.60(b) in Dimethylamine-Epichlorohydrin Copolymer. Total Amine Value ...... 178.3130(b) Total Available Methanol Method, dated December 19, 1995 ...... 172.867 Viscoelastometric method ‘‘Direct Reading Viscoelastometric Method 177.1810(c)(1)(ii) for Determining Class Transition Points of Styrene Block Polymers’’. Viscosity Determination of n-butoxypoly (oxyethylene) poly 173.340(a)(4) (oxypropylene) glycol, dated April 26, 1995. ‘‘Yeasts—A Toxonomic Study,’’ 2nd Ed., 1970 by Jacomina Lodder 173.160(b)(2); 173.165(b)(2)

Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of Product Policy (HFS–206) 5100 Paint Branch Parkway, College Park, 20740

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VerDate May<04>2004 11:24 May 05, 2004 Jkt 203066 PO 00000 Frm 00016 Fmt 8187 Sfmt 8187 Y:\SGML\203066B.XXX 203066B Material Approved for Incorporation by Reference 21 CFR (PARTS 170 TO 199)—Continued FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES—Continued 21 CFR International Dairy Federation (IDF) Standard 140A: Cheese and 172.155(c) Cheese Rind—Determination of Natamycin Content—Method by Molecular Absorption Spectrometry and by High-Performance Liq- uid Chromatography, 1992. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of Petition Control (HFS–215) 5100 Paint Branch Parkway, College Park, Maryland 20740 ASTM D 1646–92: Standard Test Method for Rubber—Viscosity and 177.2600(c)(4)(i) Vulcanization Characteristics (Mooney Viscometer). ‘‘Determination of Residual a,b-Olefinic and Trans Olefinic 177.2600(c)(4)(i) Unsaturation Levels in HNBR,’’ developed October 1, 1991 by Polysar Rubber Corp. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of Petition Review 5100 Paint Branch Parkway, College Park, Maryland 20740 ‘‘Determination of 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) 173.370(c) Peroxyacid/Peroxide-Containing Solutions’’, August 21, 2001. Hydrogen Peroxide and Peracid (as Peracetic Acid) Content, dated 173.370(c) July 26, 2000.

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Title 1—General Provisions

I Administrative Committee of the Federal Register (Parts 1—49) II Office of the Federal Register (Parts 50—299) IV Miscellaneous Agencies (Parts 400—500)

Title 2 [Reserved]

Title 3—The President

I Executive Office of the President (Parts 100—199)

Title 4—Accounts

I General Accounting Office (Parts 1—99)

Title 5—Administrative Personnel

I Office of Personnel Management (Parts 1—1199) II Merit Systems Protection Board (Parts 1200—1299) III Office of Management and Budget (Parts 1300—1399) V The International Organizations Employees Loyalty Board (Parts 1500—1599) VI Federal Retirement Thrift Investment Board (Parts 1600—1699) VIII Office of Special Counsel (Parts 1800—1899) IX Appalachian Regional Commission (Parts 1900—1999) XI Armed Forces Retirement Home (Part 2100) XIV Federal Labor Relations Authority, General Counsel of the Fed- eral Labor Relations Authority and Federal Service Impasses Panel (Parts 2400—2499) XV Office of Administration, Executive Office of the President (Parts 2500—2599) XVI Office of Government Ethics (Parts 2600—2699) XXI Department of the Treasury (Parts 3100—3199) XXII Federal Deposit Insurance Corporation (Part 3201) XXIII Department of Energy (Part 3301) XXIV Federal Energy Regulatory Commission (Part 3401) XXV Department of the Interior (Part 3501) XXVI Department of Defense (Part 3601)

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XXVIII Department of Justice (Part 3801) XXIX Federal Communications Commission (Parts 3900—3999) XXX Farm Credit System Insurance Corporation (Parts 4000—4099) XXXI Farm Credit Administration (Parts 4100—4199) XXXIII Overseas Private Investment Corporation (Part 4301) XXXV Office of Personnel Management (Part 4501) XL Interstate Commerce Commission (Part 5001) XLI Commodity Futures Trading Commission (Part 5101) XLII Department of Labor (Part 5201) XLIII National Science Foundation (Part 5301) XLV Department of Health and Human Services (Part 5501) XLVI Postal Rate Commission (Part 5601) XLVII Federal Trade Commission (Part 5701) XLVIII Nuclear Regulatory Commission (Part 5801) L Department of Transportation (Part 6001) LII Export-Import Bank of the United States (Part 6201) LIII Department of Education (Parts 6300—6399) LIV Environmental Protection Agency (Part 6401) LV National Endowment for the Arts (Part 6501) LVI National Endowment for the Humanities (Part 6601) LVII General Services Administration (Part 6701) LVIII Board of Governors of the Federal Reserve System (Part 6801) LIX National Aeronautics and Space Administration (Part 6901) LX United States Postal Service (Part 7001) LXI National Labor Relations Board (Part 7101) LXII Equal Employment Opportunity Commission (Part 7201) LXIII Inter-American Foundation (Part 7301) LXV Department of Housing and Urban Development (Part 7501) LXVI National Archives and Records Administration (Part 7601) LXVII Institute of Museum and Library Services (Part 7701) LXIX Tennessee Valley Authority (Part 7901) LXXI Consumer Product Safety Commission (Part 8101) LXXIII Department of Agriculture (Part 8301) LXXIV Federal Mine Safety and Health Review Commission (Part 8401) LXXVI Federal Retirement Thrift Investment Board (Part 8601) LXXVII Office of Management and Budget (Part 8701)

Title 6—Homeland Security

I Department of Homeland Security, Office of the Secretary (Parts 0—99)

600

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SUBTITLE A—OFFICE OF THE SECRETARY OF AGRICULTURE (PARTS 0—26) SUBTITLE B—REGULATIONS OF THE DEPARTMENT OF AGRICULTURE I Agricultural Marketing Service (Standards, Inspections, Mar- keting Practices), Department of Agriculture (Parts 27—209) II Food and Nutrition Service, Department of Agriculture (Parts 210—299) III Animal and Plant Health Inspection Service, Department of Ag- riculture (Parts 300—399) IV Federal Crop Insurance Corporation, Department of Agriculture (Parts 400—499) V Agricultural Research Service, Department of Agriculture (Parts 500—599) VI Natural Resources Conservation Service, Department of Agri- culture (Parts 600—699) VII Farm Service Agency, Department of Agriculture (Parts 700— 799) VIII Grain Inspection, Packers and Stockyards Administration (Fed- eral Grain Inspection Service), Department of Agriculture (Parts 800—899) IX Agricultural Marketing Service (Marketing Agreements and Or- ders; Fruits, Vegetables, Nuts), Department of Agriculture (Parts 900—999) X Agricultural Marketing Service (Marketing Agreements and Or- ders; Milk), Department of Agriculture (Parts 1000—1199) XI Agricultural Marketing Service (Marketing Agreements and Or- ders; Miscellaneous Commodities), Department of Agriculture (Parts 1200—1299) XIV Commodity Credit Corporation, Department of Agriculture (Parts 1400—1499) XV Foreign Agricultural Service, Department of Agriculture (Parts 1500—1599) XVI Rural Telephone Bank, Department of Agriculture (Parts 1600— 1699) XVII Rural Utilities Service, Department of Agriculture (Parts 1700— 1799) XVIII Rural Housing Service, Rural Business-Cooperative Service, Rural Utilities Service, and Farm Service Agency, Depart- ment of Agriculture (Parts 1800—2099) XX Local Television Loan Guarantee Board (Parts 2200—2299) XXVI Office of Inspector General, Department of Agriculture (Parts 2600—2699) XXVII Office of Information Resources Management, Department of Agriculture (Parts 2700—2799) XXVIII Office of Operations, Department of Agriculture (Parts 2800— 2899) XXIX Office of Energy, Department of Agriculture (Parts 2900—2999) XXX Office of the Chief Financial Officer, Department of Agriculture (Parts 3000—3099)

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XXXI Office of Environmental Quality, Department of Agriculture (Parts 3100—3199) XXXII Office of Procurement and Property Management, Department of Agriculture (Parts 3200—3299) XXXIII Office of Transportation, Department of Agriculture (Parts 3300—3399) XXXIV Cooperative State Research, Education, and Extension Service, Department of Agriculture (Parts 3400—3499) XXXV Rural Housing Service, Department of Agriculture (Parts 3500— 3599) XXXVI National Agricultural Statistics Service, Department of Agri- culture (Parts 3600—3699) XXXVII Economic Research Service, Department of Agriculture (Parts 3700—3799) XXXVIII World Agricultural Outlook Board, Department of Agriculture (Parts 3800—3899) XLI [Reserved] XLII Rural Business-Cooperative Service and Rural Utilities Service, Department of Agriculture (Parts 4200—4299)

Title 8—Aliens and Nationality

I Department of Homeland Security (Immigration and Naturaliza- tion) (Parts 1—499) V Executive Office for Immigration Review, Department of Justice (Parts 1000—1399)

Title 9—Animals and Animal Products

I Animal and Plant Health Inspection Service, Department of Ag- riculture (Parts 1—199) II Grain Inspection, Packers and Stockyards Administration (Packers and Stockyards Programs), Department of Agri- culture (Parts 200—299) III Food Safety and Inspection Service, Department of Agriculture (Parts 300—599)

Title 10—Energy

I Nuclear Regulatory Commission (Parts 0—199) II Department of Energy (Parts 200—699) III Department of Energy (Parts 700—999) X Department of Energy (General Provisions) (Parts 1000—1099) XVII Defense Nuclear Facilities Safety Board (Parts 1700—1799) XVIII Northeast Interstate Low-Level Radioactive Waste Commission (Part 1800)

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I Federal Election Commission (Parts 1—9099)

Title 12—Banks and Banking

I Comptroller of the Currency, Department of the Treasury (Parts 1—199) II Federal Reserve System (Parts 200—299) III Federal Deposit Insurance Corporation (Parts 300—399) IV Export-Import Bank of the United States (Parts 400—499) V Office of Thrift Supervision, Department of the Treasury (Parts 500—599) VI Farm Credit Administration (Parts 600—699) VII National Credit Union Administration (Parts 700—799) VIII Federal Financing Bank (Parts 800—899) IX Federal Housing Finance Board (Parts 900—999) XI Federal Financial Institutions Examination Council (Parts 1100—1199) XIV Farm Credit System Insurance Corporation (Parts 1400—1499) XV Department of the Treasury (Parts 1500—1599) XVII Office of Federal Housing Enterprise Oversight, Department of Housing and Urban Development (Parts 1700—1799) XVIII Community Development Financial Institutions Fund, Depart- ment of the Treasury (Parts 1800—1899)

Title 13—Business Credit and Assistance

I Small Business Administration (Parts 1—199) III Economic Development Administration, Department of Com- merce (Parts 300—399) IV Emergency Steel Guarantee Loan Board, Department of Com- merce (Parts 400—499) V Emergency Oil and Gas Guaranteed Loan Board, Department of Commerce (Parts 500—599)

Title 14—Aeronautics and Space

I Federal Aviation Administration, Department of Transportation (Parts 1—199) II Office of the Secretary, Department of Transportation (Aviation Proceedings) (Parts 200—399) III Commercial Space Transportation, Federal Aviation Adminis- tration, Department of Transportation (Parts 400—499) V National Aeronautics and Space Administration (Parts 1200— 1299) VI Air Transportation System Stabilization (Parts 1300—1399)

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SUBTITLE A—OFFICE OF THE SECRETARY OF COMMERCE (PARTS 0— 29) SUBTITLE B—REGULATIONS RELATING TO COMMERCE AND FOREIGN TRADE I Bureau of the Census, Department of Commerce (Parts 30—199) II National Institute of Standards and Technology, Department of Commerce (Parts 200—299) III International Trade Administration, Department of Commerce (Parts 300—399) IV Foreign-Trade Zones Board, Department of Commerce (Parts 400—499) VII Bureau of Industry and Security, Department of Commerce (Parts 700—799) VIII Bureau of Economic Analysis, Department of Commerce (Parts 800—899) IX National Oceanic and Atmospheric Administration, Department of Commerce (Parts 900—999) XI Technology Administration, Department of Commerce (Parts 1100—1199) XIII East-West Foreign Trade Board (Parts 1300—1399) XIV Minority Business Development Agency (Parts 1400—1499) SUBTITLE C—REGULATIONS RELATING TO FOREIGN TRADE AGREE- MENTS XX Office of the United States Trade Representative (Parts 2000— 2099) SUBTITLE D—REGULATIONS RELATING TO TELECOMMUNICATIONS AND INFORMATION XXIII National Telecommunications and Information Administration, Department of Commerce (Parts 2300—2399)

Title 16—Commercial Practices

I Federal Trade Commission (Parts 0—999) II Consumer Product Safety Commission (Parts 1000—1799)

Title 17—Commodity and Securities Exchanges

I Commodity Futures Trading Commission (Parts 1—199) II Securities and Exchange Commission (Parts 200—399) IV Department of the Treasury (Parts 400—499)

Title 18—Conservation of Power and Water Resources

I Federal Energy Regulatory Commission, Department of Energy (Parts 1—399) III Delaware River Basin Commission (Parts 400—499) VI Water Resources Council (Parts 700—799)

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VIII Susquehanna River Basin Commission (Parts 800—899) XIII Tennessee Valley Authority (Parts 1300—1399)

Title 19—Customs Duties

I Bureau of Customs and Border Protection, Department of Home- land Security; Department of the Treasury (Parts 0—199) II United States International Trade Commission (Parts 200—299) III International Trade Administration, Department of Commerce (Parts 300—399) IV Bureau of Immigration and Customs Enforcement, Department of Homeland Security (Parts 400—599)

Title 20—Employees’ Benefits

I Office of Workers’ Compensation Programs, Department of Labor (Parts 1—199) II Railroad Retirement Board (Parts 200—399) III Social Security Administration (Parts 400—499) IV Employees Compensation Appeals Board, Department of Labor (Parts 500—599) V Employment and Training Administration, Department of Labor (Parts 600—699) VI Employment Standards Administration, Department of Labor (Parts 700—799) VII Benefits Review Board, Department of Labor (Parts 800—899) VIII Joint Board for the Enrollment of Actuaries (Parts 900—999) IX Office of the Assistant Secretary for Veterans’ Employment and Training, Department of Labor (Parts 1000—1099)

Title 21—Food and Drugs

I Food and Drug Administration, Department of Health and Human Services (Parts 1—1299) II Drug Enforcement Administration, Department of Justice (Parts 1300—1399) III Office of National Drug Control Policy (Parts 1400—1499)

Title 22—Foreign Relations

I Department of State (Parts 1—199) II Agency for International Development (Parts 200—299) III Peace Corps (Parts 300—399) IV International Joint Commission, United States and Canada (Parts 400—499) V Broadcasting Board of Governors (Parts 500—599) VII Overseas Private Investment Corporation (Parts 700—799) IX Foreign Service Grievance Board Regulations (Parts 900—999)

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X Inter-American Foundation (Parts 1000—1099) XI International Boundary and Water Commission, United States and Mexico, United States Section (Parts 1100—1199) XII United States International Development Cooperation Agency (Parts 1200—1299) XIV Foreign Service Labor Relations Board; Federal Labor Relations Authority; General Counsel of the Federal Labor Relations Authority; and the Foreign Service Impasse Disputes Panel (Parts 1400—1499) XV African Development Foundation (Parts 1500—1599) XVI Japan-United States Friendship Commission (Parts 1600—1699) XVII United States Institute of Peace (Parts 1700—1799)

Title 23—Highways

I Federal Highway Administration, Department of Transportation (Parts 1—999) II National Highway Traffic Safety Administration and Federal Highway Administration, Department of Transportation (Parts 1200—1299) III National Highway Traffic Safety Administration, Department of Transportation (Parts 1300—1399)

Title 24—Housing and Urban Development

SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (PARTS 0—99) SUBTITLE B—REGULATIONS RELATING TO HOUSING AND URBAN DE- VELOPMENT I Office of Assistant Secretary for Equal Opportunity, Department of Housing and Urban Development (Parts 100—199) II Office of Assistant Secretary for Housing-Federal Housing Com- missioner, Department of Housing and Urban Development (Parts 200—299) III Government National Mortgage Association, Department of Housing and Urban Development (Parts 300—399) IV Office of Housing and Office of Multifamily Housing Assistance Restructuring, Department of Housing and Urban Develop- ment (Parts 400—499) V Office of Assistant Secretary for Community Planning and De- velopment, Department of Housing and Urban Development (Parts 500—599) VI Office of Assistant Secretary for Community Planning and De- velopment, Department of Housing and Urban Development (Parts 600—699) [Reserved] VII Office of the Secretary, Department of Housing and Urban Devel- opment (Housing Assistance Programs and Public and Indian Housing Programs) (Parts 700—799)

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VIII Office of the Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Section 8 Housing Assistance Programs, Section 202 Di- rect Loan Program, Section 202 Supportive Housing for the El- derly Program and Section 811 Supportive Housing for Persons With Disabilities Program) (Parts 800—899) IX Office of Assistant Secretary for Public and Indian Housing, De- partment of Housing and Urban Development (Parts 900—1699) X Office of Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Interstate Land Sales Registration Program) (Parts 1700—1799) XII Office of Inspector General, Department of Housing and Urban Development (Parts 2000—2099) XX Office of Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Parts 3200—3899) XXV Neighborhood Reinvestment Corporation (Parts 4100—4199)

Title 25—Indians

I Bureau of Indian Affairs, Department of the Interior (Parts 1— 299) II Indian Arts and Crafts Board, Department of the Interior (Parts 300—399) III National Indian Gaming Commission, Department of the Inte- rior (Parts 500—599) IV Office of Navajo and Hopi Indian Relocation (Parts 700—799) V Bureau of Indian Affairs, Department of the Interior, and Indian Health Service, Department of Health and Human Services (Part 900) VI Office of the Assistant Secretary-Indian Affairs, Department of the Interior (Parts 1000—1199) VII Office of the Special Trustee for American Indians, Department of the Interior (Part 1200)

Title 26—Internal Revenue

I Internal Revenue Service, Department of the Treasury (Parts 1— 899)

Title 27—Alcohol, Tobacco Products and Firearms

I Alcohol and Tobacco Tax and Trade Bureau, Department of the Treasury (Parts 1—399) II Bureau of Alcohol, Tobacco, Firearms, and Explosives, Depart- ment of Justice (Parts 400—699)

Title 28—Judicial Administration

I Department of Justice (Parts 0—299)

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III Federal Prison Industries, Inc., Department of Justice (Parts 300—399) V Bureau of Prisons, Department of Justice (Parts 500—599) VI Offices of Independent Counsel, Department of Justice (Parts 600—699) VII Office of Independent Counsel (Parts 700—799) VIII Court Services and Offender Supervision Agency for the District of Columbia (Parts 800—899) IX National Crime Prevention and Privacy Compact Council (Parts 900—999) XI Department of Justice and Department of State (Parts 1100— 1199)

Title 29—Labor

SUBTITLE A—OFFICE OF THE SECRETARY OF LABOR (PARTS 0—99) SUBTITLE B—REGULATIONS RELATING TO LABOR I National Labor Relations Board (Parts 100—199) II Office of Labor-Management Standards, Department of Labor (Parts 200—299) III National Railroad Adjustment Board (Parts 300—399) IV Office of Labor-Management Standards, Department of Labor (Parts 400—499) V Wage and Hour Division, Department of Labor (Parts 500—899) IX Construction Industry Collective Bargaining Commission (Parts 900—999) X National Mediation Board (Parts 1200—1299) XII Federal Mediation and Conciliation Service (Parts 1400—1499) XIV Equal Employment Opportunity Commission (Parts 1600—1699) XVII Occupational Safety and Health Administration, Department of Labor (Parts 1900—1999) XX Occupational Safety and Health Review Commission (Parts 2200—2499) XXV Employee Benefits Security Administration, Department of Labor (Parts 2500—2599) XXVII Federal Mine Safety and Health Review Commission (Parts 2700—2799) XL Pension Benefit Guaranty Corporation (Parts 4000—4999)

Title 30—Mineral Resources

I Mine Safety and Health Administration, Department of Labor (Parts 1—199) II Minerals Management Service, Department of the Interior (Parts 200—299) III Board of Surface Mining and Reclamation Appeals, Department of the Interior (Parts 300—399) IV Geological Survey, Department of the Interior (Parts 400—499)

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VII Office of Surface Mining Reclamation and Enforcement, Depart- ment of the Interior (Parts 700—999)

Title 31—Money and Finance: Treasury

SUBTITLE A—OFFICE OF THE SECRETARY OF THE TREASURY (PARTS 0—50) SUBTITLE B—REGULATIONS RELATING TO MONEY AND FINANCE I Monetary Offices, Department of the Treasury (Parts 51—199) II Fiscal Service, Department of the Treasury (Parts 200—399) IV Secret Service, Department of the Treasury (Parts 400—499) V Office of Foreign Assets Control, Department of the Treasury (Parts 500—599) VI Bureau of Engraving and Printing, Department of the Treasury (Parts 600—699) VII Federal Law Enforcement Training Center, Department of the Treasury (Parts 700—799) VIII Office of International Investment, Department of the Treasury (Parts 800—899) IX Federal Claims Collection Standards (Department of the Treas- ury—Department of Justice) (Parts 900—999)

Title 32—National Defense

SUBTITLE A—DEPARTMENT OF DEFENSE I Office of the Secretary of Defense (Parts 1—399) V Department of the Army (Parts 400—699) VI Department of the Navy (Parts 700—799) VII Department of the Air Force (Parts 800—1099) SUBTITLE B—OTHER REGULATIONS RELATING TO NATIONAL DE- FENSE XII Defense Logistics Agency (Parts 1200—1299) XVI Selective Service System (Parts 1600—1699) XVIII National Counterintelligence Center (Parts 1800—1899) XIX Central Intelligence Agency (Parts 1900—1999) XX Information Security Oversight Office, National Archives and Records Administration (Parts 2000—2099) XXI National Security Council (Parts 2100—2199) XXIV Office of Science and Technology Policy (Parts 2400—2499) XXVII Office for Micronesian Status Negotiations (Parts 2700—2799) XXVIII Office of the Vice President of the United States (Parts 2800— 2899)

Title 33—Navigation and Navigable Waters

I Coast Guard, Department of Homeland Security (Parts 1—199) II Corps of Engineers, Department of the Army (Parts 200—399)

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IV Saint Lawrence Seaway Development Corporation, Department of Transportation (Parts 400—499)

Title 34—Education

SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF EDU- CATION (PARTS 1—99) SUBTITLE B—REGULATIONS OF THE OFFICES OF THE DEPARTMENT OF EDUCATION I Office for Civil Rights, Department of Education (Parts 100—199) II Office of Elementary and Secondary Education, Department of Education (Parts 200—299) III Office of Special Education and Rehabilitative Services, Depart- ment of Education (Parts 300—399) IV Office of Vocational and Adult Education, Department of Edu- cation (Parts 400—499) V Office of Bilingual Education and Minority Languages Affairs, Department of Education (Parts 500—599) VI Office of Postsecondary Education, Department of Education (Parts 600—699) XI National Institute for Literacy (Parts 1100—1199) SUBTITLE C—REGULATIONS RELATING TO EDUCATION XII National Council on Disability (Parts 1200—1299)

Title 35—Panama Canal

I Panama Canal Regulations (Parts 1—299)

Title 36—Parks, Forests, and Public Property

I National Park Service, Department of the Interior (Parts 1—199) II Forest Service, Department of Agriculture (Parts 200—299) III Corps of Engineers, Department of the Army (Parts 300—399) IV American Battle Monuments Commission (Parts 400—499) V Smithsonian Institution (Parts 500—599) VII Library of Congress (Parts 700—799) VIII Advisory Council on Historic Preservation (Parts 800—899) IX Pennsylvania Avenue Development Corporation (Parts 900—999) X Presidio Trust (Parts 1000—1099) XI Architectural and Transportation Barriers Compliance Board (Parts 1100—1199) XII National Archives and Records Administration (Parts 1200—1299) XV Oklahoma City National Memorial Trust (Part 1501) XVI Morris K. Udall Scholarship and Excellence in National Environ- mental Policy Foundation (Parts 1600—1699)

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I United States Patent and Trademark Office, Department of Commerce (Parts 1—199) II Copyright Office, Library of Congress (Parts 200—299) IV Assistant Secretary for Technology Policy, Department of Com- merce (Parts 400—499) V Under Secretary for Technology, Department of Commerce (Parts 500—599)

Title 38—Pensions, Bonuses, and Veterans’ Relief

I Department of Veterans Affairs (Parts 0—99)

Title 39—Postal Service

I United States Postal Service (Parts 1—999) III Postal Rate Commission (Parts 3000—3099)

Title 40—Protection of Environment

I Environmental Protection Agency (Parts 1—1099) IV Environmental Protection Agency and Department of Justice (Parts 1400—1499) V Council on Environmental Quality (Parts 1500—1599) VI Chemical Safety and Hazard Investigation Board (Parts 1600— 1699) VII Environmental Protection Agency and Department of Defense; Uniform National Discharge Standards for Vessels of the Armed Forces (Parts 1700—1799)

Title 41—Public Contracts and Property Management

SUBTITLE B—OTHER PROVISIONS RELATING TO PUBLIC CONTRACTS 50 Public Contracts, Department of Labor (Parts 50–1—50–999) 51 Committee for Purchase From People Who Are Blind or Severely Disabled (Parts 51–1—51–99) 60 Office of Federal Contract Compliance Programs, Equal Employ- ment Opportunity, Department of Labor (Parts 60–1—60–999) 61 Office of the Assistant Secretary for Veterans’ Employment and Training Service, Department of Labor (Parts 61–1—61–999) SUBTITLE C—FEDERAL PROPERTY MANAGEMENT REGULATIONS SYSTEM 101 Federal Property Management Regulations (Parts 101–1—101–99) 102 Federal Management Regulation (Parts 102–1—102–299) 105 General Services Administration (Parts 105–1—105–999) 109 Department of Energy Property Management Regulations (Parts 109–1—109–99) 114 Department of the Interior (Parts 114–1—114–99) 115 Environmental Protection Agency (Parts 115–1—115–99)

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128 Department of Justice (Parts 128–1—128–99) SUBTITLE D—OTHER PROVISIONS RELATING TO PROPERTY MANAGE- MENT [RESERVED] SUBTITLE E—FEDERAL INFORMATION RESOURCES MANAGEMENT REGULATIONS SYSTEM 201 Federal Information Resources Management Regulation (Parts 201–1—201–99) [Reserved] SUBTITLE F—FEDERAL TRAVEL REGULATION SYSTEM 300 General (Parts 300–1—300–99) 301 Temporary Duty (TDY) Travel Allowances (Parts 301–1—301–99) 302 Relocation Allowances (Parts 302–1—302–99) 303 Payment of Expenses Connected with the Death of Certain Em- ployees (Part 303–70) 304 Payment of Travel Expenses from a Non-Federal Source (Parts 304–1—304–99)

Title 42—Public Health

I Public Health Service, Department of Health and Human Serv- ices (Parts 1—199) IV Centers for Medicare & Medicaid Services, Department of Health and Human Services (Parts 400—499) V Office of Inspector General-Health Care, Department of Health and Human Services (Parts 1000—1999)

Title 43—Public Lands: Interior

SUBTITLE A—OFFICE OF THE SECRETARY OF THE INTERIOR (PARTS 1—199) SUBTITLE B—REGULATIONS RELATING TO PUBLIC LANDS I Bureau of Reclamation, Department of the Interior (Parts 200— 499) II Bureau of Land Management, Department of the Interior (Parts 1000—9999) III Utah Reclamation Mitigation and Conservation Commission (Parts 10000—10010)

Title 44—Emergency Management and Assistance

I Federal Emergency Management Agency, Department of Home- land Security (Parts 0—399) IV Department of Commerce and Department of Transportation (Parts 400—499)

Title 45—Public Welfare

SUBTITLE A—DEPARTMENT OF HEALTH AND HUMAN SERVICES (PARTS 1—199) SUBTITLE B—REGULATIONS RELATING TO PUBLIC WELFARE

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II Office of Family Assistance (Assistance Programs), Administra- tion for Children and Families, Department of Health and Human Services (Parts 200—299) III Office of Child Support Enforcement (Child Support Enforce- ment Program), Administration for Children and Families, Department of Health and Human Services (Parts 300—399) IV Office of Refugee Resettlement, Administration for Children and Families, Department of Health and Human Services (Parts 400—499) V Foreign Claims Settlement Commission of the United States, Department of Justice (Parts 500—599) VI National Science Foundation (Parts 600—699) VII Commission on Civil Rights (Parts 700—799) VIII Office of Personnel Management (Parts 800—899) X Office of Community Services, Administration for Children and Families, Department of Health and Human Services (Parts 1000—1099) XI National Foundation on the Arts and the Humanities (Parts 1100—1199) XII Corporation for National and Community Service (Parts 1200— 1299) XIII Office of Human Development Services, Department of Health and Human Services (Parts 1300—1399) XVI Legal Services Corporation (Parts 1600—1699) XVII National Commission on Libraries and Information Science (Parts 1700—1799) XVIII Harry S. Truman Scholarship Foundation (Parts 1800—1899) XXI Commission on Fine Arts (Parts 2100—2199) XXIII Arctic Research Commission (Part 2301) XXIV James Madison Memorial Fellowship Foundation (Parts 2400— 2499) XXV Corporation for National and Community Service (Parts 2500— 2599)

Title 46—Shipping

I Coast Guard, Department of Homeland Security (Parts 1—199) II Maritime Administration, Department of Transportation (Parts 200—399) III Coast Guard (Great Lakes Pilotage), Department of Homeland Security (Parts 400—499) IV Federal Maritime Commission (Parts 500—599)

Title 47—Telecommunication

I Federal Communications Commission (Parts 0—199) II Office of Science and Technology Policy and National Security Council (Parts 200—299)

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III National Telecommunications and Information Administration, Department of Commerce (Parts 300—399)

Title 48—Federal Acquisition Regulations System

1 Federal Acquisition Regulation (Parts 1—99) 2 Department of Defense (Parts 200—299) 3 Department of Health and Human Services (Parts 300—399) 4 Department of Agriculture (Parts 400—499) 5 General Services Administration (Parts 500—599) 6 Department of State (Parts 600—699) 7 United States Agency for International Development (Parts 700—799) 8 Department of Veterans Affairs (Parts 800—899) 9 Department of Energy (Parts 900—999) 10 Department of the Treasury (Parts 1000—1099) 12 Department of Transportation (Parts 1200—1299) 13 Department of Commerce (Parts 1300—1399) 14 Department of the Interior (Parts 1400—1499) 15 Environmental Protection Agency (Parts 1500—1599) 16 Office of Personnel Management, Federal Employees Health Benefits Acquisition Regulation (Parts 1600—1699) 17 Office of Personnel Management (Parts 1700—1799) 18 National Aeronautics and Space Administration (Parts 1800— 1899) 19 Broadcasting Board of Governors (Parts 1900—1999) 20 Nuclear Regulatory Commission (Parts 2000—2099) 21 Office of Personnel Management, Federal Employees Group Life Insurance Federal Acquisition Regulation (Parts 2100—2199) 23 Social Security Administration (Parts 2300—2399) 24 Department of Housing and Urban Development (Parts 2400— 2499) 25 National Science Foundation (Parts 2500—2599) 28 Department of Justice (Parts 2800—2899) 29 Department of Labor (Parts 2900—2999) 30 Department of Homeland Security, Homeland Security Acquisi- tion Regulation (HSAR) (Parts 3000—3099) 34 Department of Education Acquisition Regulation (Parts 3400— 3499) 35 Panama Canal Commission (Parts 3500—3599) 44 Federal Emergency Management Agency (Parts 4400—4499) 51 Department of the Army Acquisition Regulations (Parts 5100— 5199) 52 Department of the Navy Acquisition Regulations (Parts 5200— 5299) 53 Department of the Air Force Federal Acquisition Regulation Supplement (Parts 5300—5399)

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54 Defense Logistics Agency, Department of Defense (Parts 5400— 5499) 57 African Development Foundation (Parts 5700—5799) 61 General Services Administration Board of Contract Appeals (Parts 6100—6199) 63 Department of Transportation Board of Contract Appeals (Parts 6300—6399) 99 Cost Accounting Standards Board, Office of Federal Procure- ment Policy, Office of Management and Budget (Parts 9900— 9999)

Title 49—Transportation

SUBTITLE A—OFFICE OF THE SECRETARY OF TRANSPORTATION (PARTS 1—99) SUBTITLE B—OTHER REGULATIONS RELATING TO TRANSPORTATION I Research and Special Programs Administration, Department of Transportation (Parts 100—199) II Federal Railroad Administration, Department of Transportation (Parts 200—299) III Federal Motor Carrier Safety Administration, Department of Transportation (Parts 300—399) IV Coast Guard, Department of Homeland Security (Parts 400—499) V National Highway Traffic Safety Administration, Department of Transportation (Parts 500—599) VI Federal Transit Administration, Department of Transportation (Parts 600—699) VII National Railroad Passenger Corporation (AMTRAK) (Parts 700—799) VIII National Transportation Safety Board (Parts 800—999) X Surface Transportation Board, Department of Transportation (Parts 1000—1399) XI Bureau of Transportation Statistics, Department of Transpor- tation (Parts 1400—1499) XII Transportation Security Administration, Department of Home- land Security (Parts 1500—1599)

Title 50—Wildlife and Fisheries

I United States Fish and Wildlife Service, Department of the Inte- rior (Parts 1—199) II National Marine Fisheries Service, National Oceanic and Atmos- pheric Administration, Department of Commerce (Parts 200— 299) III International Fishing and Related Activities (Parts 300—399) IV Joint Regulations (United States Fish and Wildlife Service, De- partment of the Interior and National Marine Fisheries Serv- ice, National Oceanic and Atmospheric Administration, De- partment of Commerce); Endangered Species Committee Reg- ulations (Parts 400—499)

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V Marine Mammal Commission (Parts 500—599) VI Fishery Conservation and Management, National Oceanic and Atmospheric Administration, Department of Commerce (Parts 600—699)

CFR Index and Finding Aids

Subject/Agency Index List of Agency Prepared Indexes Parallel Tables of Statutory Authorities and Rules List of CFR Titles, Chapters, Subchapters, and Parts Alphabetical List of Agencies Appearing in the CFR

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VerDate May<04>2004 11:24 May 05, 2004 Jkt 203066 PO 00000 Frm 00036 Fmt 8092 Sfmt 8092 Y:\SGML\203066B.XXX 203066B Alphabetical List of Agencies Appearing in the CFR (Revised as of April 1, 2004)

CFR Title, Subtitle or Agency Chapter Administrative Committee of the Federal Register 1, I Advanced Research Projects Agency 32, I Advisory Council on Historic Preservation 36, VIII African Development Foundation 22, XV Federal Acquisition Regulation 48, 57 Agency for International Development, United States 22, II Federal Acquisition Regulation 48, 7 Agricultural Marketing Service 7, I, IX, X, XI Agricultural Research Service 7, V Agriculture Department 5, LXXIII Agricultural Marketing Service 7, I, IX, X, XI Agricultural Research Service 7, V Animal and Plant Health Inspection Service 7, III; 9, I Chief Financial Officer, Office of 7, XXX Commodity Credit Corporation 7, XIV Cooperative State Research, Education, and Extension 7, XXXIV Service Economic Research Service 7, XXXVII Energy, Office of 7, XXIX Environmental Quality, Office of 7, XXXI Farm Service Agency 7, VII, XVIII Federal Acquisition Regulation 48, 4 Federal Crop Insurance Corporation 7, IV Food and Nutrition Service 7, II Food Safety and Inspection Service 9, III Foreign Agricultural Service 7, XV Forest Service 36, II Grain Inspection, Packers and Stockyards Administration 7, VIII; 9, II Information Resources Management, Office of 7, XXVII Inspector General, Office of 7, XXVI National Agricultural Library 7, XLI National Agricultural Statistics Service 7, XXXVI Natural Resources Conservation Service 7, VI Operations, Office of 7, XXVIII Procurement and Property Management, Office of 7, XXXII Rural Business-Cooperative Service 7, XVIII, XLII Rural Development Administration 7, XLII Rural Housing Service 7, XVIII, XXXV Rural Telephone Bank 7, XVI Rural Utilities Service 7, XVII, XVIII, XLII Secretary of Agriculture, Office of 7, Subtitle A Transportation, Office of 7, XXXIII World Agricultural Outlook Board 7, XXXVIII Air Force Department 32, VII Federal Acquisition Regulation Supplement 48, 53 Air Transportation Stabilization Board 14, VI Alcohol and Tobacco Tax and Trade Bureau 27, I Alcohol, Tobacco, Firearms, and Explosives, Bureau of 27, II AMTRAK 49, VII American Battle Monuments Commission 36, IV American Indians, Office of the Special Trustee 25, VII Animal and Plant Health Inspection Service 7, III; 9, I Appalachian Regional Commission 5, IX

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VerDate May<04>2004 11:24 May 05, 2004 Jkt 203066 PO 00000 Frm 00037 Fmt 8092 Sfmt 8092 Y:\SGML\203066B.XXX 203066B CFR Title, Subtitle or Agency Chapter Architectural and Transportation Barriers Compliance Board 36, XI Arctic Research Commission 45, XXIII Armed Forces Retirement Home 5, XI Army Department 32, V Engineers, Corps of 33, II; 36, III Federal Acquisition Regulation 48, 51 Benefits Review Board 20, VII Bilingual Education and Minority Languages Affairs, Office of 34, V Blind or Severely Disabled, Committee for Purchase From 41, 51 People Who Are Broadcasting Board of Governors 22, V Federal Acquisition Regulation 48, 19 Census Bureau 15, I Centers for Medicare & Medicaid Services 42, IV Central Intelligence Agency 32, XIX Chief Financial Officer, Office of 7, XXX Child Support Enforcement, Office of 45, III Children and Families, Administration for 45, II, III, IV, X Civil Rights, Commission on 45, VII Civil Rights, Office for 34, I Coast Guard 33, I; 46, I; 49, IV Coast Guard (Great Lakes Pilotage) 46, III Commerce Department 44, IV Census Bureau 15, I Economic Affairs, Under Secretary 37, V Economic Analysis, Bureau of 15, VIII Economic Development Administration 13, III Emergency Management and Assistance 44, IV Federal Acquisition Regulation 48, 13 Fishery Conservation and Management 50, VI Foreign-Trade Zones Board 15, IV Industry and Security, Bureau of 15, VII International Trade Administration 15, III; 19, III National Institute of Standards and Technology 15, II National Marine Fisheries Service 50, II, IV, VI National Oceanic and Atmospheric Administration 15, IX; 50, II, III, IV, VI National Telecommunications and Information 15, XXIII; 47, III Administration National Weather Service 15, IX Patent and Trademark Office, United States 37, I Productivity, Technology and Innovation, Assistant 37, IV Secretary for Secretary of Commerce, Office of 15, Subtitle A Technology, Under Secretary for 37, V Technology Administration 15, XI Technology Policy, Assistant Secretary for 37, IV Commercial Space Transportation 14, III Commodity Credit Corporation 7, XIV Commodity Futures Trading Commission 5, XLI; 17, I Community Planning and Development, Office of Assistant 24, V, VI Secretary for Community Services, Office of 45, X Comptroller of the Currency 12, I Construction Industry Collective Bargaining Commission 29, IX Consumer Product Safety Commission 5, LXXI; 16, II Cooperative State Research, Education, and Extension 7, XXXIV Service Copyright Office 37, II Corporation for National and Community Service 45, XII, XXV Cost Accounting Standards Board 48, 99 Council on Environmental Quality 40, V Court Services and Offender Supervision Agency for the 28, VIII District of Columbia Customs and Border Protection Bureau 19, I Defense Contract Audit Agency 32, I Defense Department 5, XXVI; 32, Subtitle A; 40, VII

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2001 21 CFR—Continued 66 FR Page 21 CFR 66 FR Chapter I—Continued Page 181 Nomenclature change ...... 56034 Chapter I 184 Nomenclature change ....56034, 66742 170 Nomenclature change ...... 56034 189 Nomenclature change ...... 56034 172 Nomenclature change ....56034, 66742 190 Nomenclature change ...... 56034 172.133 (c)(2) redesignated as 190.6 (a) amended ...... 17359 (c)(3); (b) and new (c)(3) revised; new (c)(2) added ...... 13653 172.155 (c) revised...... 13847 2002 172.615 (a) table amended ...... 38153 21 CFR 67 FR (a) table corrected...... 53711 Page 172.892 (i) introductory text re- Chapter I vised; (i) table amended...... 17509 170.3 (e)(2) revised; (e)(3) added ...... 35729 173 Nomenclature change ....56034, 66742 170.100—170.106 (Subpart D) 173.115 Added ...... 27022 Added ...... 35729 173.325 (b)(1)(iii), (iv) and (v) 171.1 (i)(1) revised ...... 35731 amended...... 22922 171.7 (c) added ...... 35731 (f) redesignated as (g); new (f) 171.133 (b)(2) and (3) correctly re- added ...... 31841 vised; CFR correction ...... 66045 173.368 Added ...... 33830 172.829 Added ...... 45310 173.370 (b) and (c) revised ...... 48208 173.325 (g) redesignated as (h); 175 Nomenclature change ...... 56034 new (g) added ...... 15720 175.105 (c)(5) table amended...... 13654 173.357 (a)(2) table amended...... 42716 175.125 (a)(9) added; (b)(1) re- 173.368 (d) corrected ...... 271 vised...... 13654 173.370 (b)(1) revised...... 61784 176 Nomenclature change ...... 56034 174.5 (d)(5) added ...... 35731 176.170 (b)(2) table amended...... 13655 179.25 OMB number ...... 9585 176.180 (b)(2) table amended...... 13655 (c) revised ...... 35731 177 Nomenclature change ....56034, 66742 178 Nomenclature change ....56034, 66742 178.3297 (e) table amended...... 6469 2003 178.3400 (c) table amended ...... 13655 21 CFR 68 FR 179.21 (a)(4), (b)(1)(iii) and (2)(iv) Page added...... 18539 Chapter I 179.45 (b) introductory text and 172 Nomenclature change ...... 15355 (d) introductory text amend- Hearing denied...... 46403 ed ...... 10575 Technical correction ...... 57799, 57957 180 Nomenclature change ...... 56034 172.380 Added ...... 9003

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21 CFR—Continued 68 FR 2004 Page Chapter I—Continued (Regulations published from January 1, 172.615 (a) table corrected; CFR 2004, through April 1, 2004) correction ...... 17277 172.800 Introductory text and (c) 21 CFR 69 FR revised; (d) and (e) removed ...... 75413 Page 172.867 (e) revised...... 46402 Chapter I 172.869 Added ...... 50072 170 Nomenclature change ...... 13717 173 Nomenclature change ...... 15355 177.1390 (c)(1)(i)(g) added ...... 15668 177 Nomenclature change ...... 15355 177.1520 (b) table amended ...... 16481 178 Nomenclature change ...... 15355 184 Nomenclature change ...... 13717 184 Nomenclature change ...... 24879 Æ

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