21 Part 170 to 199 Revised as of April 1, 2001
Food and Drugs
Containing a codification of documents of general applicability and future effect
As of April 1, 2001
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: (202) 512-1800 Tax: (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 ...... 573
Table of CFR Titles and Chapters ...... 587
Alphabetical List of Agencies Appearing in the CFR ...... 605
Redesignation Table ...... 615
List of CFR Sections Affected ...... 617
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To cite the regulations in this volume use title, part and section num- ber. 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 agen- cies 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 deter- mine 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, 2001), 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 usu- ally 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.
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RAYMOND A. MOSLEY, Director, Office of the Federal Register. April 1, 2001.
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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, in- cludes Chapter II—Drug Enforcement Administration, Department of Justice, and Chapter III—Office of National Drug Control Policy. The contents of these vol- umes represent all current regulations codified under this title of the CFR as of April 1, 2001.
Redesignation tables for Chapter I—Food and Drug Administration appear in the Finding Aids section for the volumes containing parts 170–199 and 500–599.
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(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 chap- ter 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 regula- tions 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.
SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (CON’T.) Part Page 170 Food additives ...... 5 171 Food additive petitions ...... 21 172 Food additives permitted for direct addition to food for human consumption ...... 26 173 Secondary direct food additives permitted in food for human consumption ...... 111 174 Indirect food additives: General ...... 140 175 Indirect food additives: Adhesives and components of coatings ...... 141 176 Indirect food additives: Paper and paperboard com- ponents ...... 183 177 Indirect food additives: Polymers ...... 221 178 Indirect food additives: Adjuvants, production aids, and sanitizers ...... 340 179 Irradiation in the production, processing and han- dling of food ...... 432 180 Food additives permitted in food or in contact with food on an interim basis pending additional study ...... 438 181 Prior-sanctioned food ingredients ...... 443 182 Substances generally recognized as safe ...... 447 184 Direct food substances affirmed as generally recog- nized as safe ...... 461 3
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Part Page 186 Indirect food substances affirmed as generally rec- ognized as safe ...... 559 189 Substances prohibited from use in human food ...... 564 190 Dietary supplements ...... 569 191–199 [Reserved]
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PART 170—FOOD ADDITIVES Stat. 1040 et seq., as amended (21 U.S.C. 301–392). Subpart A—General Provisions (e)(1) Food additives includes all sub- stances not exempted by section 201(s) Sec. of the act, the intended use of which 170.3 Definitions. 170.6 Opinion letters on food additive sta- results or may reasonably be expected tus. to result, directly or indirectly, either 170.10 Food additives in standardized foods. in their becoming a component of food 170.15 Adoption of regulation on initiative or otherwise affecting the characteris- of Commissioner. tics of food. A material used in the pro- 170.17 Exemption for investigational use and procedure for obtaining authoriza- duction of containers and packages is tion to market edible products from ex- subject to the definition if it may rea- perimental animals. sonably be expected to become a com- 170.18 Tolerances for related food additives. ponent, or to affect the characteristics, 170.19 Pesticide chemicals in processed directly or indirectly, of food packed in foods. the container. ‘‘Affecting the charac- Subpart B—Food Additive Safety teristics of food’’ does not include such physical effects, as protecting contents 170.20 General principles for evaluating the of packages, preserving shape, and pre- safety of food additives. venting moisture loss. If there is no 170.22 Safety factors to be considered. migration of a packaging component 170.30 Eligibility for classification as gen- erally recognized as safe (GRAS). from the package to the food, it does 170.35 Affirmation of generally recognized not become a component of the food as safe (GRAS) status. and thus is not a food additive. A sub- 170.38 Determination of food additive sta- stance that does not become a compo- tus. nent of food, but that is used, for exam- 170.39 Threshold of regulation for sub- ple, in preparing an ingredient of the stances used in food–contact articles. food to give a different flavor, texture, Subpart C—Specific Administrative Rulings or other characteristic in the food, and Decisions may be a food additive. (2) Uses of food additives not requiring 170.45 Fluorine-containing compounds. a listing regulation. Substances used in 170.50 Glycine (aminoacetic acid) in food for human consumption. food-contact articles (e.g., food-pack- 170.60 Nitrites and/or nitrates in curing pre- aging and food-processing equipment) mixes. that migrate, or may be expected to AUTHORITY: 21 U.S.C. 321, 341, 342, 346a, 348, migrate, into food at such negligible 371. levels that they have been exempted from regulation as food additives under SOURCE: 42 FR 14483, Mar. 15, 1977, unless otherwise noted. § 170.39. (f) Common use in food means a sub- Subpart A—General Provisions stantial history of consumption of a substance for food use by a significant § 170.3 Definitions. number of consumers. For the purposes of this subchapter, (g) The word substance in the defini- the following definitions apply: tion of the term ‘‘food additive’’ in- (a) Secretary means the Secretary of cludes a food or food component con- Health and Human Services. sisting of one or more ingredients. (b) Department means the Department (h) Scientific procedures include those of Health and Human Services. human, animal, analytical, and other (c) Commissioner means the Commis- scientific studies, whether published or sioner of Food and Drugs. unpublished, appropriate to establish (d) As used in this part, the term act the safety of a substance. means the Federal Food, Drug, and (i) Safe or safety means that there is Cosmetic Act approved June 25, 1936, 52 a reasonable certainty in the minds of
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competent scientists that the sub- 33B of the report of the National Acad- stance is not harmful under the in- emy of Sciences/National Research tended conditions of use. It is impos- Council report, ‘‘A Comprehensive Sur- sible in the present state of scientific vey of Industry on the Use of Food knowledge to establish with complete Chemicals Generally Recognized as certainty the absolute harmlessness of Safe’’ (September 1972), which is incor- the use of any substance. Safety may porated by reference. Copies are avail- be determined by scientific procedures able from the National Technical Infor- or by general recognition of safety. In mation Service (NTIS), 5285 Port Royal determining safety, the following fac- Rd., Springfield, VA 22161, or available tors shall be considered: for inspection at the Office of the Fed- (1) The probable consumption of the eral Register, 800 North Capitol Street, substance and of any substance formed NW., suite 700, Washington, DC 20408: in or on food because of its use. (1) Baked goods and baking mixes, in- (2) The cumulative effect of the sub- cluding all ready-to-eat and ready-to- stance in the diet, taking into account bake products, flours, and mixes re- any chemically or pharmacologically quiring preparation before serving. related substance or substances in such (2) Beverages, alcoholic, including diet. malt beverages, wines, distilled liq- (3) Safety factors which, in the opin- uors, and cocktail mix. ion of experts qualified by scientific (3) Beverages and beverage bases, training and experience to evaluate the nonalcoholic, including only special or safety of food and food ingredients, are spiced teas, soft drinks, coffee sub- generally recognized as appropriate. stitutes, and fruit and vegetable fla- (j) The term nonperishable processed vored gelatin drinks. food means any processed food not sub- (4) Breakfast cereals, including ject to rapid decay or deterioration ready-to-eat and instant and regular that would render it unfit for consump- hot cereals. tion. Examples are flour, sugar, cere- (5) Cheeses, including curd and whey als, packaged cookies, and crackers. cheeses, cream, natural, grating, proc- Not included are hermetically sealed essed, spread, dip, and miscellaneous foods or manufactured dairy products cheeses. and other processed foods requiring re- (6) Chewing gum, including all forms. frigeration. (7) Coffee and tea, including regular, (k) General recognition of safety shall decaffeinated, and instant types. be determined in accordance with (8) Condiments and relishes, includ- § 170.30. ing plain seasoning sauces and spreads, (l) Prior sanction means an explicit olives, pickles, and relishes, but not approval granted with respect to use of spices or herbs. a substance in food prior to September (9) Confections and frostings, includ- 6, 1958, by the Food and Drug Adminis- ing candy and flavored frostings, tration or the United States Depart- marshmallows, baking chocolate, and ment of Agriculture pursuant to the brown, lump, rock, maple, powdered, Federal Food, Drug, and Cosmetic Act, and raw sugars. the Poultry Products Inspection Act, (10) Dairy product analogs, including or the Meat Inspection Act. nondairy milk, frozen or liquid cream- (m) Food includes human food, sub- ers, coffee whiteners, toppings, and stances migrating to food from food- other nondairy products. contact articles, pet food, and animal (11) Egg products, including liquid, feed. frozen, or dried eggs, and egg dishes (n) The following general food cat- made therefrom, i.e., egg roll, egg foo egories are established to group spe- young, egg salad, and frozen multi- cific related foods together for the pur- course egg meals, but not fresh eggs. pose of establishing tolerances or limi- (12) Fats and oils, including mar- tations for the use of direct human garine, dressings for salads, butter, food ingredients. Individual food prod- salad oils, shortenings and cooking ucts will be included within these cat- oils. egories according to the detailed clas- (13) Fish products, including all pre- sifications lists contained in Exhibit pared main dishes, salads, appetizers,
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frozen multicourse meals, and spreads (29) Meat products, including all containing fish, shellfish, and other meats and meat containing dishes, sal- aquatic animals, but not fresh fish. ads, appetizers, frozen multicourse (14) Fresh eggs, including cooked meat meals, and sandwich ingredients eggs and egg dishes made only from prepared by commercial processing or fresh shell eggs. using commercially processed meats (15) Fresh fish, including only fresh with home preparation. and frozen fish, shellfish, and other (30) Milk, whole and skim, including aquatic animals. only whole, lowfat, and skim fluid (16) Fresh fruits and fruit juices, in- milks. cluding only raw fruits, citrus, melons, (31) Milk products, including flavored and berries, and home-prepared ‘‘ades’’ milks and milk drinks, dry milks, top- and punches made therefrom. pings, snack dips, spreads, weight con- (17) Fresh meats, including only fresh trol milk beverages, and other milk or- or home-frozen beef or veal, pork, lamb igin products. or mutton and home-prepared fresh (32) Nuts and nut products, including meat-containing dishes, salads, appe- whole or shelled tree nuts, peanuts, co- tizers, or sandwich spreads made there- conut, and nut and peanut spreads. from. (33) Plant protein products, including (18) Fresh poultry, including only the National Academy of Sciences/Na- fresh or home-frozen poultry and game tional Research Council ‘‘reconstituted birds and home-prepared fresh poultry- vegetable protein’’ category, and meat, containing dishes, salads, appetizers, or poultry, and fish substitutes, analogs, sandwich spreads made therefrom. and extender products made from plant (19) Fresh vegetables, tomatoes, and proteins. potatoes, including only fresh and (34) Poultry products, including all home-prepared vegetables. poultry and poultry-containing dishes, (20) Frozen dairy desserts and mixes, salads, appetizers, frozen multicourse including ice cream, ice milks, sher- poultry meals, and sandwich ingredi- bets, and other frozen dairy desserts ents prepared by commercial proc- and specialties. essing or using commercially processed (21) Fruit and water ices, including poultry with home preparation. all frozen fruit and water ices. (35) Processed fruits and fruit juices, (22) Gelatins, puddings, and fillings, including all commercially processed including flavored gelatin desserts, fruits, citrus, berries, and mixtures; puddings, custards, parfaits, pie fill- ings, and gelatin base salads. salads, juices and juice punches, con- centrates, dilutions, ‘‘ades’’, and drink (23) Grain products and pastas, in- substitutes made therefrom. cluding macaroni and noodle products, rice dishes, and frozen multicourse (36) Processed vegetables and vege- meals, without meat or vegetables. table juices, including all commer- (24) Gravies and sauces, including all cially processed vegetables, vegetable meat sauces and gravies, and tomato, dishes, frozen multicourse vegetable milk, buttery, and specialty sauces. meals, and vegetable juices and blends. (25) Hard candy and cough drops, in- (37) Snack foods, including chips, cluding all hard type candies. pretzels, and other novelty snacks. (26) Herbs, seeds, spices, seasonings, (38) Soft candy, including candy bars, blends, extracts, and flavorings, includ- chocolates, fudge, mints, and other ing all natural and artificial spices, chewy or nougat candies. blends, and flavors. (39) Soups, home-prepared, including (27) Jams and jellies, home-prepared, meat, fish, poultry, vegetable, and including only home-prepared jams, combination home-prepared soups. jellies, fruit butters, preserves, and (40) Soups and soup mixes, including sweet spreads. commercially prepared meat, fish, (28) Jams and jellies, commercial, in- poultry, vegetable, and combination cluding only commercially processed soups and soup mixes. jams, jellies, fruit butters, preserves, (41) Sugar, white, granulated, includ- and sweet spreads. ing only white granulated sugar.
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(42) Sugar substitutes, including Sciences/National Research Council granulated, liquid, and tablet sugar under ‘‘dough conditioner.’’ substitutes. (7) ‘‘Drying agents’’: Substances with (43) Sweet sauces, toppings, and syr- moisture-absorbing ability, used to ups, including chocolate, berry, fruit, maintain an environment of low mois- corn syrup, and maple sweet sauces and ture. toppings. (8) ‘‘Emulsifiers and emulsifier (o) The following terms describe the salts’’: Substances which modify sur- physical or technical functional effects face tension in the component phase of for which direct human food ingredi- an emulsion to establish a uniform dis- ents may be added to foods. They are persion or emulsion. adopted from the National Academy of (9) ‘‘Enzymes’’: Enzymes used to im- Sciences/National Research Council na- prove food processing and the quality tional survey of food industries, re- of the finished food. ported to the Food and Drug Adminis- (10) ‘‘Firming agents’’: Substances tration under the contract title ‘‘A added to precipitate residual pectin, Comprehensive Survey of Industry on thus strengthening the supporting tis- the Use of Food Chemicals Generally sue and preventing its collapse during Recognized as Safe’’ (September 1972), processing. which is incorporated by reference. (11) ‘‘Flavor enhancers’’: Substances Copies are available from the National added to supplement, enhance, or mod- Technical Information Service (NTIS), ify the original taste and/or aroma of a 5285 Port Royal Rd., Springfield, VA food, without imparting a char- 22161, or available for inspection at the acteristic taste or aroma of its own. Office of the Federal Register, 800 (12) ‘‘Flavoring agents and adju- North Capitol Street, NW., suite 700, vants’’: Substances added to impart or Washington, DC 20408: help impart a taste or aroma in food. (1) ‘‘Anticaking agents and free-flow agents’’: Substances added to finely (13) ‘‘Flour treating agents’’: Sub- powdered or crystalline food products stances added to milled flour, at the to prevent caking, lumping, or agglom- mill, to improve its color and/or baking eration. qualities, including bleaching and ma- (2) ‘‘Antimicrobial agents’’: Sub- turing agents. stances used to preserve food by pre- (14) ‘‘Formulation aids’’: Substances venting growth of microorganisms and used to promote or produce a desired subsequent spoilage, including fungi- physical state or texture in food, in- stats, mold and rope inhibitors, and the cluding carriers, binders, fillers, plasti- effects listed by the National Academy cizers, film-formers, and tableting aids, of Sciences/National Research Council etc. under ‘‘preservatives.’’ (15) ‘‘Fumigants’’: Volatile sub- (3) ‘‘Antioxidants’’: Substances used stances used for controlling insects or to preserve food by retarding deteriora- pests. tion, rancidity, or discoloration due to (16) ‘‘Humectants’’: Hygroscopic sub- oxidation. stances incorporated in food to pro- (4) ‘‘Colors and coloring adjuncts’’: mote retention of moisture, including Substances used to impart, preserve, or moisture-retention agents and anti- enhance the color or shading of a food, dusting agents. including color stabilizers, color fixa- (17) ‘‘Leavening agents’’: Substances tives, color-retention agents, etc. used to produce or stimulate produc- (5) ‘‘Curing and pickling agents’’: tion of carbon dioxide in baked goods Substances imparting a unique flavor to impart a light texture, including and/or color to a food, usually pro- yeast, yeast foods, and calcium salts ducing an increase in shelf life sta- listed by the National Academy of bility. Sciences/National Research Council (6) ‘‘Dough strengtheners’’: Sub- under ‘‘dough conditioners.’’ stances used to modify starch and glu- (18) ‘‘Lubricants and release agents’’: ten, thereby producing a more stable Substances added to food contact sur- dough, including the applicable effects faces to prevent ingredients and fin- listed by the National Academy of ished products from sticking to them.
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(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- uct, including the applicable effect list- [42 FR 14483, Mar. 15, 1977, as amended at 47 ed by the National Academy of FR 11835, Mar. 19, 1982; 53 FR 16546, May 10, Sciences/National Research Council 1988; 54 FR 24896, June 12, 1989; 60 FR 36595, July 17, 1995] 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, acids, alkalies, and neutralizing (a) Over the years the Food and Drug agents. Administration has given informal (24) ‘‘Processing aids’’: Substances written opinions to inquiries as to the used as manufacturing aids to enhance safety of articles intended for use as the appeal or utility of a food or food components of, or in contact with, component, including clarifying food. Prior to the enactment of the agents, clouding agents, catalysts, floc- Food Additives Amendment of 1958 culents, filter aids, and crystallization (Pub. L. 85–929; Sept. 6, 1958), these inhibitors, etc. opinions were given pursuant to sec- (25) ‘‘Propellants, aerating agents, tion 402(a)(1) of the Federal Food, and gases’’: Gases used to supply force Drug, and Cosmetic Act, which reads in to expel a product or used to reduce the part: ‘‘A food shall be deemed to be amount of oxygen in contact with the adulterated if it bears or contains any food in packaging. poisonous or deleterious substance (26) ‘‘Sequestrants’’: Substances which may render it injurious to which combine with polyvalent metal health’’. ions to form a soluble metal complex, (b) Since enactment of the Food Ad- to improve the quality and stability of ditives Amendment, the Food and Drug products. Administration has advised such in- (27) ‘‘Solvents and vehicles’’: Sub- quirers that an article: stances used to extract or dissolve an- (1) Is a food additive within the other substance. meaning of section 201(s) of the act; or (28) ‘‘Stabilizers and thickeners’’: (2) Is generally recognized as safe Substances used to produce viscous so- (GRAS); or lutions or dispersions, to impart body, (3) Has prior sanction or approval improve consistency, or stabilize emul- under that amendment; or sions, including suspending and body- (4) Is not a food additive under the ing agents, setting agents, jellying conditions of intended use. agents, and bulking agents, etc. (c) In the interest of the public (29) ‘‘Surface-active agents’’: Sub- health, such articles which have been stances used to modify surface prop- considered in the past by the Food and erties of liquid food components for a Drug Administration to be safe under variety of effects, other than emulsi- the provisions of section 402(a)(1), or to fiers, but including solubilizing agents, be generally recognized as safe for dispersants, detergents, wetting their intended use, or to have prior agents, rehydration enhancers, whip- sanction or approval, or not to be food
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additives under the conditions of in- sion of a food additive in such defini- tended use, must be reexamined in the tion and standard of identity, the pro- light of current scientific information visions of the regulations in this part and current principles for evaluating shall apply with respect to the infor- the safety of food additives if their use mation that must be submitted with is to be continued. respect to the food additive. Since sec- (d) Because of the time span in- tion 409(b)(5) of the Act requires that volved, copies of many of the letters in the Secretary publish notice of a peti- which the Food and Drug Administra- tion for the establishment of a food-ad- tion has expressed an informal opinion ditive regulation within 30 days after concerning the status of such articles filing, notice of a petition relating to a may no longer be in the file of the Food definition and standard of identity and Drug Administration. In the ab- shall also be published within that sence of information concerning the time limitation if it includes a request, names and uses made of all the articles so designated, for the establishment of referred to in such letters, their safety a regulation pertaining to a food addi- of use cannot be reexamined. For this tive. reason all food additive status opinions (b) If a petition for a definition and of the kind described in paragraph (c) standard of identity contains a pro- of this section given by the Food and posal for a food-additive regulation, Drug Administration are hereby re- and the petitioner fails to designate it voked. as such, the Commissioner, upon deter- (e) The prior opinions of the kind de- mining that the petition includes a scribed in paragraph (c) of this section proposal for a food-additive regulation, will be replaced by qualified and cur- shall so notify the petitioner and shall rent opinions if the recipient of each thereafter proceed in accordance with such letter forwards a copy of each to the regulations in this part. the Department of Health and Human (c) A regulation will not be issued al- Services, Food and Drug Administra- lowing the use of a food additive in a tion, Center for Food Safety and Ap- food for which a definition and stand- plied Nutrition, 200 C Street SW., ard of identity is established, unless its Washington, DC 20204, along with a issuance is in conformity with section copy of his letter of inquiry, on or be- 401 of the Act or with the terms of a fore July 23, 1970. (f) This section does not apply to food temporary permit issued under § 130.17 additive status opinion letters per- of this chapter. When the contemplated taining to articles that were considered use of such additive complies with the by the Food and Drug Administration terms of a temporary permit, the food to be food additives nor to articles in- additive regulation will be conditioned cluded in regulations in parts 170 on such compliance and will expire through 189 of this chapter if the arti- with the expiration of the temporary cles are used in accordance with the re- permit. quirements of such regulations. § 170.15 Adoption of regulation on ini- [42 FR 14483, Mar. 15, 1977, as amended at 54 tiative of Commissioner. FR 24896, June 12, 1989] (a) The Commissioner upon his own § 170.10 Food additives in standard- initiative may propose the issuance of ized foods. a regulation prescribing, with respect to any particular use of a food additive, (a) The inclusion of food ingredients the conditions under which such addi- in parts 170 through 189 of this chapter tive may be safely used. Notice of such does not imply that these ingredients proposal shall be published in the FED- may be used in standardized foods un- ERAL REGISTER and shall state the rea- less they are recognized as optional in- sons for the proposal. gredients in applicable food standards. Where a petition is received for the (b) Action upon a proposal made by issuance or amendment of a regulation the Commissioner shall proceed as pro- establishing a definition and standard vided in part 10 of this chapter. of identity for a food under section 401 [42 FR 14486, Mar. 15, 1977, as amended at 42 of the Act, which proposes the inclu- FR 15673, Mar. 22, 1977]
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§ 170.17 Exemption for investigational having additive toxic effects and will use and procedure for obtaining au- be considered as related food additives. thorization to market edible prod- (b) Tolerances established for such ucts from experimental animals. related food additives may limit the A food additive or food containing a amount of a common component that food additive intended for investiga- may be present, or may limit the tional use by qualified experts shall be amount of biological activity (such as exempt from the requirements of sec- cholinesterase inhibition) that may be tion 409 of the Act under the following present or may limit the total amount conditions: of related food additives that may be (a) If intended for investigational use present. in vitro or in laboratory research ani- (c) Where food additives from two or mals, it bears a label which states more chemicals in the same class are prominently, in addition to the other present in or on a food, the tolerance information required by the act, the for the total of such additives shall be warning: the same as that for the additive hav- ing the lowest numerical tolerance in Caution. Contains a new food additive for this class, unless there are available investigational use only in laboratory re- methods that permit quantitative de- search animals or for tests in vitro. Not for termination of the amount of each food use in humans. additive present or unless it is shown (b) If intended for use in animals that a higher tolerance is reasonably other than laboratory research animals required for the combined additives to and if the edible products of the ani- accomplish the physical or technical mals are to be marketed as food, per- effect for which such combined addi- mission for the marketing of the edible tives are intended and that the higher products as food has been requested by tolerance will be safe. the sponsor, and authorization has (d) Where residues from two or more been granted by the Food and Drug Ad- additives in the same class are present ministration in accordance with § 511.1 in or on a food and there are available of this chapter or by the Department of methods that permit quantitative de- Agriculture in accordance with 9 CFR termination of each residue, the quan- 309.17, and it bears a label which states tity of combined residues that are prominently, in addition to the other within the tolerance may be deter- information required by the Act, the mined as follows: warning: (1) Determine the quantity of each residue present. Caution. Contains a new food additive for (2) Divide the quantity of each res- use only in investigational animals. Not for use in humans. idue by the tolerance that would apply Edible products of investigational animals if it occurred alone, and multiply by are not to be used for food unless authoriza- 100 to determine the percentage of the tion has been granted by the U.S. Food and permitted amount of residue present. Drug Administration or by the U.S. Depart- (3) Add the percentages so obtained ment of Agriculture. for all residues present. (c) If intended for nonclinical labora- (4) The sum of the percentage shall tory studies in food-producing animals, not exceed 100 percent. the study is conducted in compliance § 170.19 Pesticide chemicals in proc- with the regulations set forth in part 58 essed foods. of this chapter. When pesticide chemical residues [42 FR 14483, Mar. 15, 1977, as amended at 43 occur in processed foods due to the use FR 60021, Dec. 22, 1978] of raw agricultural commodities that bore or contained a pesticide chemical § 170.18 Tolerances for related food ad- in conformity with an exemption ditives. granted or a tolerance prescribed under (a) Food additives that cause similar section 408 of the Act, the processed or related pharmacological effects will food will not be regarded as adulter- be regarded as a class, and in the ab- ated so long as good manufacturing sence of evidence to the contrary, as practice has been followed in removing
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any residue from the raw agricultural lined procedures. In reaching a deci- commodity in the processing (such as sion, the Commissioner will give due by peeling or washing) and so long as weight to the anticipated levels and the concentration of the residue in the patterns of consumption of the additive processed food when ready to eat is not specified or reasonably inferrable. For greater than the tolerance prescribed the purposes of this section, the prin- for the raw agricultural commodity. ciples for evaluating safety of additives But when the concentration of residue set forth in the abovementioned publi- in the processed food when ready to eat cations will apply to any substance is higher than the tolerance prescribed that may properly be classified as a for the raw agricultural commodity, food additive as defined in section the processed food is adulterated unless 201(s) of the Act. the higher concentration is permitted (b) Upon written request describing by a tolerance obtained under section the proposed use of an additive and the 409 of the Act. For example, if fruit proposed experiments to determine its bearing a residue of 7 parts per million safety, the Commissioner will advise a of DDT permitted on the raw agricul- person who wishes to establish the tural commodity is dried and a residue safety of a food additive whether he be- in excess of 7 parts per million of DDT lieves the experiments planned will results on the dried fruit, the dehy- 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 § 170.22 Safety factors to be consid- that is itself ready to eat, and which ered. contains a higher residue than allowed 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 mixing with other foods to reduce the safety factors will be applied in deter- residue in the mixed food below the tol- mining whether the proposed use of a erance prescribed for the raw agricul- food additive will be safe: Except where tural commodity. evidence is submitted which justifies use of a different safety factor, a safety Subpart B—Food Additive Safety factor in applying animal experimen- tation data to man of 100 to 1, will be § 170.20 General principles for evalu- used; that is, a food additive for use by ating the safety of food additives. man will not be granted a tolerance (a) In reaching a decision on any pe- that will exceed 1⁄100th of the maximum tition filed under section 409 of the amount demonstrated to be without Act, the Commissioner will give full harm to experimental animals. consideration to the specific biological properties of the compound and the § 170.30 Eligibility for classification as adequacy of the methods employed to generally recognized as safe (GRAS). demonstrate safety for the proposed use, and the Commissioner will be (a) General recognition of safety may guided by the principles and procedures be based only on the views of experts for establishing the safety of food addi- qualified by scientific training and ex- tives stated in current publications of perience to evaluate the safety of sub- the National Academy of Sciences-Na- stances directly or indirectly added to tional Research Council. A petition food. The basis of such views may be ei- will not be denied, however, by reason ther (1) scientific procedures or (2) in of the petitioner’s having followed pro- the case of a substance used in food cedures other than those outlined in prior to January 1, 1958, through expe- the publications of the National Acad- rience based on common use in food. emy of Sciences-National Research General recognition of safety requires Council if, from available evidence, the common knowledge about the sub- Commissioner finds that the proce- stance throughout the scientific com- dures used give results as reliable as, munity knowledgeable about the safety or more reliable than, those reasonably of substances directly or indirectly to be expected from the use of the out- added to food.
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(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. achieve general recognition of safety (e) Food ingredients were listed as only through scientific procedures. GRAS in part 182 of this chapter during (2) A substance used in food prior to 1958–1962 without a detailed scientific January 1, 1958, may be generally rec- review of all available data and infor- ognized as safe through experience mation relating to their safety. Begin- based on its common use in food when ning in 1969, the Food and Drug Admin- that use occurred exclusively or pri- istration has undertaken a systematic marily outside of the United States if review of the status of all ingredients the information about the experience used in food on the determination that establishes that the use of the sub- they are GRAS or subject to a prior stance is safe within the meaning of sanction. All determinations of GRAS the act (see § 170.3(i)). Common use in status or food additive status or prior food prior to January 1, 1958, that oc- sanction status pursuant to this review curred outside of the United States shall be handled pursuant to §§ 170.35, shall be documented by published or 170.38, and 180.1 of this chapter. Affir- other information and shall be corrobo- mation of GRAS status shall be an- rated by information from a second, nounced in part 184 or § 186.1 of this independent source that confirms the chapter. history and circumstances of use of the (f) The status of the following food substance. The information used to ingredients will be reviewed and af- document and to corroborate the his- firmed as GRAS or determined to be a tory and circumstances of use of the food additive or subject to a prior sanc- substance must be generally available; tion pursuant to § 170.35, § 170.38, or that is, it must be widely available in § 180.1 of this chapter: the country in which the history of use (1) Any substance of natural biologi- has occurred and readily available to cal origin that has been widely con- interested qualified experts in this sumed for its nutrient properties in the country. Persons claiming GRAS sta- United States prior to January 1, 1958, tus for a substance based on its com- without known detrimental effect, for mon use in food outside of the United which no health hazard is known, and States should obtain FDA concurrence which has been modified by processes that the use of the substance is GRAS. first introduced into commercial use
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after January 1, 1958, which may rea- Office of the Federal Register, 800 sonably be expected significantly to North Capitol Street, NW., suite 700, alter the composition of the substance. Washington, DC 20408. (2) Any substance of natural biologi- (2) It performs an appropriate func- cal origin that has been widely con- tion in the food or food-contact article sumed for its nutrient properties in the in which it is used. United States prior to January 1, 1958, (3) It is used at a level no higher than without known detrimental effect, for 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 toxic constituents. (i) If a substance is affirmed as GRAS (3) Distillates, isolates, extracts, and in part 184 or § 186.1 of this chapter with concentration of extracts of GRAS sub- no limitation other than good manu- stances. facturing practice, it shall be regarded (4) Reaction products of GRAS sub- as GRAS if its conditions of use are not stances. significantly different from those re- (5) Substances not of a natural bio- ported in the regulation as the basis on logical origin, including those for which the GRAS status of the sub- which evidence is offered that they are stance was affirmed. If the conditions identical to a GRAS counterpart of of use are significantly different, such natural biological origin. use of the substance may not be GRAS. (6) Substances of natural biological In such a case a manufacturer may not origin intended for consumption for rely on the regulation as authorizing other than their nutrient properties. the use but must independently estab- (g) A food ingredient that is not lish that the use is GRAS or must use GRAS or subject to a prior sanction re- the substance in accordance with a quires a food additive regulation pro- food additive regulation. mulgated under section 409 of the act (j) If an ingredient is affirmed as before it may be directly or indirectly GRAS in part 184 or § 186.1 of this chap- added to food. ter with specific limitation(s), it may (h) A food ingredient that is listed as be used in food only within such limi- GRAS in part 182 of this chapter or af- tation(s) (including the category of firmed as GRAS in part 184 or § 186.1 of food(s), the functional use(s) of the in- this chapter shall be regarded as GRAS gredient, and the level(s) of use). Any only if, in addition to all the require- use of such an ingredient not in full ments in the applicable regulation, it compliance with each such established also meets all of the following require- limitation shall require a food additive ments: regulation. (1) It complies with any applicable food grade specifications of the Food (k) Pursuant to § 170.35, a food ingre- Chemicals Codex, 2d Ed. (1972), or, if dient may be affirmed as GRAS in part specifically indicated in the GRAS af- 184 or § 186.1 of this chapter for a spe- firmation regulation, the Food Chemi- cific use(s) without a general evalua- cals Codex, 3d Ed. (1981), which are in- tion of use of the ingredient. In addi- corporated by reference, except that tion to the use(s) specified in the regu- any substance used as a component of lation, other uses of such an ingredient articles that contact food and affirmed may also be GRAS. Any affirmation of as GRAS in § 186.1 of this chapter shall GRAS status for a specific use(s), with- comply with the specifications therein, out a general evaluation of use of the or in the absence of such specifications, ingredient, is subject to reconsider- shall be of a purity suitable for its in- ation upon such evaluation. tended use. Copies may be obtained (l) New information may at any time from the National Academy Press, 2101 require reconsideration of the GRAS Constitution Ave. NW., Washington, status of a food ingredient. Any change DC 20418, or may be examined at the in part 182, part 184, or § 186.1 of this
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chapter shall be accomplished pursuant forth in § 170.30 (b) or (c) have been met, to § 170.38. in the following form: (i) Description of the substance, in- [42 FR 14483, Mar. 15, 1977, as amended at 49 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 recog- (c) Chemical Abstract Service (CAS) nized as safe (GRAS) status. registry number. (a) The Commissioner, either on his (d) Empirical formula. initiative or on the petition of an in- (e) Structural formula. terested person, may affirm the GRAS (f) Specifications for food grade ma- status of substances that directly or terial, including arsenic and heavy indirectly become components of food. metals. (Recommendation for any (b)(1) If the Commissioner proposes change in the Food Chemicals Codex on his own initiative that a substance monograph should be included where is entitled to affirmation as GRAS, he applicable.) will place all of the data and informa- (g) Quantitative compositions. tion on which he relies on public file in (h) Manufacturing process (excluding the office of the Dockets Management any trade secrets). Branch and will publish in the FEDERAL (ii) Use of the substance, including: REGISTER a notice giving the name of (a) Date when use began. the substance, its proposed uses, and (b) Information and reports or other any limitations proposed for purposes data on past uses in food. other than safety. (c) Foods in which used, and levels of (2) The FEDERAL REGISTER notice will use in such foods, and for what pur- allow a period of 60 days during which poses. any interested person may review the (iii) Methods for detecting the sub- data and information and/or file com- stance in food, including: ments with the Dockets Management (a) References to qualitative and Branch. Copies of all comments re- quantitative methods for determining ceived shall be made available for ex- the substance(s) in food, including the amination in the Dockets Management type of analytical procedures used. Branch’s office. (b) Sensitivity and reproducibility of (3) The Commissioner will evaluate such method(s). all comments received. If he concludes (iv) Information to establish the safe- that there is convincing evidence that ty and functionality of the substance the substance is GRAS as described in in food. Published scientific literature, § 170.30, he will publish a notice in the evidence that the substance is identical FEDERAL REGISTER listing the sub- to a GRAS counterpart of natural bio- stance as GRAS in part 182, part 184, or logical origin, and other data may be part 186 of this chapter, as appropriate. submitted to support safety. Any ad- (4) If, after evaluation of the com- verse information or consumer com- ments, the Commissioner concludes plaints shall be included. Complete bib- that there is a lack of convincing evi- liographic references shall be provided dence that the substance is GRAS and where a copy of the article is not pro- that it should be considered a food ad- vided. ditive subject to section 409 of the Act, (v) A statement signed by the person he shall publish a notice thereof in the responsible for the petition that to the FEDERAL REGISTER in accordance with best of his knowledge it is a represent- § 170.38. ative and balanced submission that in- (c)(1) Persons seeking the affirmation cludes unfavorable information, as well of GRAS status of substances as pro- as favorable information, known to vided in § 170.30(e), except those subject him pertinent to the evaluation of the to the NAS/NRC GRAS list survey (36 safety and functionality of the sub- FR 20546; October 23, 1971), shall submit stance. a petition for GRAS affirmation pursu- (vi) If nonclinical laboratory studies ant to part 10 of this chapter. Such pe- are involved, additional information tition shall contain information to es- and data submitted in support of filed tablish that the GRAS criteria as set petitions shall include, with respect to
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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 Dockets Management ISTER in accordance with § 170.38. Branch and will publish a notice of fil- (7) The notice of filing in the FED- ing in the FEDERAL REGISTER giving ERAL REGISTER will request submission the name of the petitioner and a brief of proof of any applicable prior sanc- description of the petition including tion for use of the ingredient under the name of the substance, its proposed conditions different from those pro- use, and any limitations proposed for posed to be determined to be GRAS. reasons other than safety. A copy of The failure of any person to come for- the notice will be mailed to the peti- ward with proof of such an applicable tioner at the time the original is sent prior sanction in response to the notice to the FEDERAL REGISTER. of filing will constitute a waiver of the (3)(i) If intended uses of the sub- right to assert or rely on such sanction stance include uses in meat, meat food at any later time. The notice of filing product, or poultry product subject to will also constitute a proposal to estab- regulation by the U.S. Department of lish a regulation under part 181 of this Agriculture (USDA) under the Poultry chapter, incorporating the same provi- Products Inspection Act (PPIA) (21 sions, in the event that such a regula- U.S.C. 451 et seq.) or Federal Meat In- tion is determined to be appropriate as spection Act (FMIA) (21 U.S.C. 601 et a result of submission of proof of such seq.), FDA shall, upon filing of the peti- an applicable prior sanction in re- tion, forward a copy of the petition or sponse to the notice of filing. relevant portions thereof to the Food (Information collection requirements were Safety and Inspection Service, USDA, approved by the Office of Management and for simultaneous review under the Budget under control number 0910–0132) PPIA and FMIA. [42 FR 14488, Mar. 15, 1977, as amended at 50 (ii) FDA will ask USDA to advise FR 7492, Feb. 22, 1985; 50 FR 16668, Apr. 26, whether the proposed meat and poultry 1985; 53 FR 16547, May 10, 1988; 62 FR 40599, uses comply with the FMIA and PPIA July 29, 1997; 65 FR 51762, Aug. 25, 2000] or, if not, whether use of the substance would be permitted in products under § 170.38 Determination of food addi- USDA jurisdiction under specified con- tive status. ditions or restrictions. (a) The Commissioner may, in ac- (4) The notice of filing in the FED- cordance with § 170.35(b)(4) or (c)(5), ERAL REGISTER will allow a period of 60 publish a notice in the FEDERAL REG- days during which any interested per- ISTER determining that a substance is son may review the petition and/or file not GRAS and is a food additive sub- comments with the Dockets Manage- ject to section 409 of the Act. ment Branch. Copies of all comments (b)(1) The Commissioner, on his own received shall be made available for ex- initiative or on the petition of any in- amination in the Dockets Management terested person, pursuant to part 10 of Branch’s office. this chapter, may issue a notice in the (5) The Commissioner will evaluate FEDERAL REGISTER proposing to deter- the petition and all available informa- mine that a substance is not GRAS and
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is a food additive subject to section 409 applicable prior sanction, the proposed of the Act. Any petition shall include regulation will so state and will re- all relevant data and information of quire any person who intends to assert the type described in § 171.130(b). The or rely on such sanction to submit Commissioner will place all of the data proof of its existence. Any regulation and information on which he relies on promulgated pursuant to this section public file in the office of the Dockets constitutes a determination that ex- Management Branch and will include cluded uses would result in adultera- in the FEDERAL REGISTER notice the tion of the food in violation of section name of the substance, its known uses, 402 of the Act, and the failure of any and a summary of the basis for the de- person to come forward with proof of termination. such an applicable prior sanction in re- (2) The FEDERAL REGISTER notice will sponse to the proposal will constitute a allow a period of 60 days during which waiver of the right to assert or rely on any interested person may review the such sanction at any later time. The data and information and/or file com- notice will also constitute a proposal ments with the Dockets Management to establish a regulation under part 181 Branch. Copies of all comments shall of this chapter, incorporating the same be made available for examination in provisions, in the event that such a the Dockets Management Branch’s of- regulation is determined to be appro- fice. priate as a result of submission of proof (3) The Commissioner will evaluate of such an applicable prior sanction in all comments received. If he concludes response to the proposal. that there is a lack of convincing evi- dence that the substance is GRAS or is [42 FR 14488, Mar. 15, 1977, as amended at 42 otherwise exempt from the definition FR 15673, Mar. 22, 1977; 54 FR 24896, June 12, of a food additive in section 201(s) of 1989] the Act, he will publish a notice there- § 170.39 Threshold of regulation for of in the FEDERAL REGISTER. If he con- substances used in food-contact ar- cludes that there is convincing evi- ticles. dence that the substance is GRAS, he will publish an order in the FEDERAL (a) A substance used in a food-con- REGISTER listing the substance as tact article (e.g., food-packaging or GRAS in part 182, part 184, or part 186 food-processing equipment) that mi- of this chapter, as appropriate. grates, or that may be expected to mi- (c) A FEDERAL REGISTER notice deter- grate, into food will be exempted from mining that a substance is a food addi- regulation as a food additive because it tive shall provide for the use of the ad- becomes a component of food at levels ditive in food or food contact surfaces that are below the threshold of regula- as follows: tion if: (1) It may promulgate a food additive (1) The substance has not been shown regulation governing use of the addi- to be a carcinogen in humans or ani- tive. mals, and there is no reason, based on (2) It may promulgate an interim the chemical structure of the sub- food additive regulation governing use stance, to suspect that the substance is of the additive. a carcinogen. The substance must also (3) It may require discontinuation of not contain a carcinogenic impurity or, the use of the additive. if it does, must not contain a carcino- (4) It may adopt any combination of genic impurity with a TD50 value based the above three approaches for dif- on chronic feeding studies reported in ferent uses or levels of use of the addi- the scientific literature or otherwise tive. available to the Food and Drug Admin- (d) If the Commissioner of Food and istration of less than 6.25 milligrams Drugs is aware of any prior sanction per kilogram bodyweight per day (The for use of the substance, he will con- TD50, for the purposes of this section, is currently propose a separate regulation the feeding dose that causes cancer in covering such use of the ingredient 50 percent of the test animals when under part 181 of this chapter. If the corrected for tumors found in control Commissioner is unaware of any such animals. If more than one TD50 value 17
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has been reported in the scientific lit- (2) Detailed information on the con- erature for a substance, the Food and ditions of use of the substance (e.g., Drug Administration will use the low- temperature, type of food with which est appropriate TD50 value in its re- the substance will come into contact, view.); the duration of the contact, and wheth- (2) The substance presents no other er the food-contact article will be for health or safety concerns because: repeated or single use applications); (i) The use in question has been (3) A clear statement as to whether shown to result in or may be expected the request for exemption from regula- to result in dietary concentrations at tion as a food additive is based on the or below 0.5 parts per billion, cor- fact that the use of the substance in responding to dietary exposure levels the food-contact article results in a di- at or below 1.5 micrograms/person/day etary concentration at or below 0.5 (based on a diet of 1,500 grams of solid parts per billion, or on the fact that it food and 1,500 grams of liquid food per involves the use of a regulated direct person per day); or food additive for which the dietary ex- (ii) The substance is currently regu- posure is at or below 1 percent of the lated for direct addition into food, and acceptable dietary intake (ADI); the dietary exposure to the substance (4) Data that will enable the Food resulting from the proposed use is at or and Drug Administration to estimate below 1 percent of the acceptable daily the daily dietary concentration result- intake as determined by safety data in ing from the proposed use of the sub- the Food and Drug Administration’s stance. These data should be in the files or from other appropriate sources; form of: (3) The substance has no technical ef- (i) Validated migration data obtained fect in or on the food to which it mi- under worst-case (time/temperature) grates; and intended use conditions utilizing ap- (4) The substance use has no signifi- propriate food simulating solvents; cant adverse impact on the environ- (ii) Information on the amount of the ment. substance used in the manufacture of (b) Notwithstanding paragraph (a) of the food-contact article; or this section, the Food and Drug Admin- (iii) Information on the residual level istration reserves the right to decline of the substance in the food-contact ar- to grant an exemption in those cases in ticle. For repeat-use articles, an esti- which available information estab- mate of the amount of food that con- lishes that the proposed use may pose a tacts a specific unit of surface area public health risk. The reasons for the over the lifetime of the article should agency’s decision to decline to grant an also be provided. (In cases where data exemption will be explained in the are provided only in the form of manu- Food and Drug Administration’s re- facturing use levels or residual levels sponse to the requestor. of the substance present in the food- (c) A request for the Food and Drug contact article, the Food and Drug Ad- Administration to exempt a use of a ministration will calculate a worst- substance from regulation as a food ad- case dietary concentration level as- ditive shall include three copies of the suming 100 percent migration.) A de- following information (If part of the tailed description of the analytical submitted material is in a foreign lan- method used to quantify the substance guage, it must be accompanied by an should also be submitted along with English translation verified to be com- data used to validate the detection plete and accurate in accordance with limit. § 10.20(c)(2) of this chapter): (iv) In cases where there is no detect- (1) The chemical composition of the able migration into food or food substance for which the request is simulants, or when no residual level of made, including, whenever possible, a substance is detected in the food-con- the name of the chemical in accord- tact article by a suitable analytical ance with current Chemical Abstract method, the Food and Drug Adminis- Service (CAS) nomenclature guidelines tration will, for the purposes of esti- and a CAS registry number, if avail- mating the dietary concentration, con- able; sider the validated detection limit of
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the method used to analyze for the sub- copy of the list of exempted substances stance. by contacting the Food and Drug Ad- (5) The results of an analysis of exist- ministration’s Office of Premarket Ap- ing toxicological information on the proval (HFS–200), 200 C St. SW., Wash- substance and its impurities. This in- ington, DC 20204. For actions requiring formation on the substance is needed an environmental assessment, the to show whether an animal carcinogen agency’s finding of no significant im- bioassay has been carried out, or pact and the evidence supporting that whether there is some other basis for finding, contained in the petitioner’s suspecting that the substance is a car- environmental assessment, also will be cinogen or potent toxin. This type of available for public inspection at the information on the impurities is need- Dockets Management Branch in ac- ed to show whether any of them are cordance with § 25.51(b)(2) of this chap- carcinogenic, and, if carcinogenic, ter. Requests for copies of releasable whether their TD50 values are greater information contained in submissions than 6.25 milligrams per kilogram requesting exemptions from the food bodyweight per day in accordance with additive regulations will be handled in paragraph (a)(1) of this section. accordance with the Food and Drug Ad- (6) Information on the environmental ministration’s Freedom of Information impact that would result from the pro- Act procedures, as described in part 20 posed use of the substance. The request of this chapter. In particular, data and should contain either a claim for cat- information that fall within the defini- egorical exclusion as specified in § 25.32 tions of a trade secret or confidential of this chapter or an environmental as- commercial or financial information sessment as specified in § 25.40 of this are not available for public disclosure chapter. in accordance with § 20.61(c) of this (d) Data to be reviewed under this chapter. section shall be submitted to the Food (f) If the request for an exemption and Drug Administration’s Office of from regulation as a food additive is Premarket Approval (HFS–200), 200 C not granted, the requestor may submit St. SW., Washington, DC 20204. a petition to the Food and Drug Ad- (e) The Food and Drug Administra- ministration for reconsideration of the tion will inform the requestor by letter decision in accordance with the provi- whether the specific food-contact ap- sions of § 10.33 of this chapter. plication is exempt from regulation as (g) If the Food and Drug Administra- a food additive or not. Although a sub- tion receives significant new informa- stance that migrates to food at a level tion that raises questions about the di- that results in a dietary concentration etary concentration or the safety of a at or below the threshold of regulation substance that the agency has exempt- will not be the subject of a regulation ed from regulation, the Food and Drug published in the FEDERAL REGISTER Administration may reevaluate the and will not appear in the Code of Fed- substance. If the Food and Drug Ad- eral Regulations, the Food and Drug ministration tentatively concludes Administration will maintain a list of that the information that is available substances exempted from regulation about the substance no longer supports as food additives under this section on an exemption for the use of the food- display at the Dockets Management contact material from the food addi- Branch. This list will include the name tive regulations, the agency will notify of the company that made the request, any persons that requested an exemp- the chemical name of the substance, tion for the substance of its tentative the specific use for which it has re- decision. The requestors will be given ceived an exemption from regulation as an opportunity to show why the use of a food additive, and any appropriate the substance should not be regulated limitations on its use. The list will not under the food additive provisions of include any trade names. This list will the act. If the requestors fail to ade- enable interested persons to see the quately respond to the new evidence, types of uses of food-contact materials the agency will notify them that fur- being exempted under the regulation. ther use of the substance in question Interested persons may also obtain a for the particular use will require a
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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 Dockets Management Branch as that authorized by regulations (40 CFR part of the file of uses of substances ex- part 180) under section 408 of the Act. empted from regulation as food addi- tives. 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 and Drug Administration plans to no- were administered in diets of experi- tify other manufacturers by means of a mental animals. notice published in the FEDERAL REG- (2) Current usage information indi- ISTER of its decision to revoke an ex- cates that the daily dietary intake of emption issued for a specific use of a glycine by humans may be substan- substance in a food contact article. (h) Guidance documents to assist re- tially increasing due to changing use questors in the preparation of submis- patterns in food technology. sions seeking exemptions from the food Therefore, the Food and Drug Adminis- additive regulations are available from tration no longer regards glycine and the Food and Drug Administration’s its salts as generally recognized as safe Office of Premarket Approval (HFS– for use in human food and all out- 200), 200 C St. SW., Washington, DC standing letters expressing sanction for 20204. Interested persons are encour- such use are rescinded. aged to obtain specific guidance from (b) The Commissioner of Food and the Food and Drug Administration on Drugs concludes that by May 8, 1971, the appropriate protocols to be used for manufacturers: obtaining migration data, on the vali- (1) Shall reformulate food products dation of the analytical methods used for human use to eliminate added gly- to quantify migration levels, on the cine and its salts; or procedures used to relate migration (2) Shall bring such products into data to dietary exposures, and on any compliance with an authorizing food other issue not specifically covered in additive regulation. A food additive pe- the Food and Drug Administration’s tition supported by toxicity data is re- guidance documents. quired to show that any proposed level [60 FR 36595, July 17, 1995, as amended at 62 of glycine or its salts added to foods for FR 40599, July 29, 1997; 65 FR 56479, Sept. 19, human consumption will be safe. 2000] (c) The status of glycine as generally recognized as safe for use in animal Subpart C—Specific Administra- feed, as prescribed in § 582.5049 of this tive Rulings and Decisions chapter, remains unchanged because the additive is considered an essential § 170.45 Fluorine-containing com- nutrient in certain animal feeds and is pounds. safe for such use under conditions of The Commissioner of Food and Drugs good feeding practice. has concluded that it is in the interest of the public health to limit the addi- § 170.60 Nitrites and/or nitrates in cur- tion of fluorine compounds to foods (a) ing premixes. to that resulting from the fluoridation (a) Nitrites and/or nitrates are food of public water supplies as stated in additives when combined in curing pre- § 250.203 of this chapter, (b) to that re- mixes with spices and/or other fla- sulting from the fluoridation of bottled voring or seasoning ingredients that
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contain or constitute a source of sec- AUTHORITY: 21 U.S.C. 321, 342, 348, 371. ondary or tertiary amines, including SOURCE: 42 FR 14489, Mar. 15, 1977, unless but not limited to essential oils, diso- otherwise noted. dium inosinate, disodium guanylate, hydrolysates of animal or plant origin Subpart A—General Provisions (such as hydrolyzed vegetable protein), oleoresins of spices, soy products, and § 171.1 Petitions. spice extractives. Such food additives (a) Petitions to be filed with the may be used only after the establish- Commissioner under the provisions of ment of an authorizing food additive section 409(b) of the Federal Food, regulation. A food additive petition Drug, and Cosmetic Act (the act) shall submitted pursuant to §§ 171.1 and be submitted in triplicate (quadru- 171.100 of this chapter, supported by plicate, if intended uses include use in data demonstrating that nitrosamines meat, meat food product, or poultry are not formed in curing premixes con- product). If any part of the material taining such food additives, is required submitted is in a foreign language, it to establish safety. shall be accompanied by an accurate (b) Nitrites and/or nitrates, when and complete English translation. The packaged separately from flavoring petition shall state petitioner’s post of- and seasoning in curing premixes, may fice address to which published notices continue to be used under prior sanc- or orders issued or objections filed pur- tions in the commercial curing of meat suant to section 409 of the Act may be and meat products and poultry prod- sent. ucts and in accordance with the provi- (b) Pertinent information may be in- sions of §§ 172.170 and 172.175 of this corporated in, and will be considered as chapter that apply to meat curing part of, a petition on the basis of spe- preparations for the home curing of cific reference to such information sub- meat and meat products, including mitted to and retained in the files of poultry and wild game. To assure safe the Food and Drug Administration. use of such ingredients the labeling of However, any reference to unpublished the premixes shall bear instructions to information furnished by a person the user that such separately packaged other than the applicant will not be ingredients are not to be combined considered unless use of such informa- until just prior to use. Encapsulating tion is authorized in a written state- or coating some or all of the ingredi- ment signed by the person who sub- ents does not constitute separate pack- mitted it. Any reference to published aging. information offered in support of a food additive petition should be accom- PART 171—FOOD ADDITIVE panied by reprints or photostatic cop- PETITIONS ies of such references. (c) Petitions shall include the fol- Subpart A—General Provisions lowing data and be submitted in the following form: Sec. 171.1 Petitions. (Date) 171.6 Amendment of petition. Name of petitioner lllllllllllll 171.7 Withdrawal of petition without preju- Post-office address lllllllllllll dice. Date lllllllllllllllllllll 171.8 Threshold of regulation for substances Name of food additive and proposed use ll used in food–contact articles. llllllllllllllllllllllll Petitions Control Branch Subpart B—Administrative Actions on Food and Drug Administration Applications Department of Health and Human Services Washington, DC 20204. 171.100 Regulation based on petition. DEAR SIRS: 171.102 Effective date of regulation. The undersigned, lllll submits this 171.110 Procedure for objections and hear- petition pursuant to section 409(b)(1) of the ings. Federal Food, Drug, and Cosmetic Act with 171.130 Procedure for amending and repeal- respect to lllll ing tolerances or exemptions from toler- ances. (Name of the food additive and proposed use)
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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 the characteristics of the substance or the D. A description of practicable methods to reliability of the controls may be specified. determine the amount of the food additive in If the food additive is a mixture of chemi- the raw, processed, and/or finished food and cals, the petition shall supply a list of all of any substance formed in or on such food substances used in the synthesis, extraction, because of its use. The test proposed shall be or other method of preparation, regardless of one that can be used for food-control pur- whether they undergo chemical change in poses and that can be applied with consistent the process. Each substance should be identi- results by any properly equipped and trained fied by its common English name and com- laboratory personnel. plete chemical name, using structural for- E. Full reports of investigations made with mulas when necessary for specific identifica- respect to the safety of the food additive. tion. If any proprietary preparation is used (A petition may be regarded as incomplete as a component, the proprietary name should unless it includes full reports of adequate be followed by a complete quantitative tests reasonably applicable to show whether statement of composition. Reasonable alter- or not the food additive will be safe for its natives for any listed substance may be spec- intended use. The reports ordinarily should ified. include detailed data derived from appro- If the petitioner does not himself perform priate animal and other biological experi- all the manufacturing, processing, and pack- ments in which the methods used and the re- ing operations for a food additive, the peti- sults obtained are clearly set forth. The peti- tion shall identify each person who will per- tion shall not omit without explanation any form a part of such operations and designate reports of investigations that would bias an the part. evaluation of the safety of the food additive.) The petition shall include stability data, F. Proposed tolerances for the food addi- and, if the data indicate that it is needed to tive, if tolerances are required in order to in- insure the identity, strength, quality, or pu- sure its safety. A petitioner may include a rity of the additive, the expiration date that proposed regulation. will be employed. G. If submitting petition to modify an ex- B. The amount of the food additive pro- isting regulation issued pursuant to section posed for use and the purposes for which it is 409(c)(1)(A) of the Act, full information on proposed, together with all directions, rec- each proposed change that is to be made in ommendations, and suggestions regarding the original regulation must be submitted. the proposed use, as well as specimens of the The petition may omit statements made in labeling proposed for the food additive and the original petition concerning which no any labeling that will be required by applica- change is proposed. A supplemental petition ble provisions of the Federal Food, Drug, and must be submitted for any change beyond Cosmetic Act on the finished food by reason the variations provided for in the original of the use of the food additive. If the additive petition and the regulation issued on the results or may reasonably be expected to re- basis of the original petition.
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H. The petitioner is required to submit ei- (ii) A protocol for a test or study, un- ther a claim for categorical exclusion under less it is shown to fall within the ex- § 25.30 or 25.32 of this chapter or an environ- emption established for trade secrets mental assessment under § 25.40 of this chap- and confidential commercial informa- ter. tion in § 20.61 of this chapter. Yours very truly, (iii) Adverse reaction reports, prod- Petitioner llllllllllllllllll uct experience reports, consumer com- By llllllllllllllllllllll plaints, and other similar data and in- (Indicate authority) formation, after deletion of: (d) The petitioner will be notified of (a) Names and any information that the date on which his petition is filed; would identify the person using the and an incomplete petition, or one that product. has not been submitted in triplicate, (b) Names and any information that will usually be retained but not filed as would identify any third party involved a petition under section 409 of the Act. with the report, such as a physician or The petitioner will be notified in what hospital or other institution. respects his petition is incomplete. (iv) A list of all ingredients contained (e) The petition must be signed by in a food additive, whether or not it is the petitioner or by his attorney or in descending order of predominance. A agent, or (if a corporation) by an au- particular ingredient or group of ingre- thorized official. dients shall be deleted from any such (f) The data specified under the sev- list prior to public disclosure if it is eral lettered headings should be sub- shown to fall within the exemption es- mitted on separate sheets or sets of tablished in § 20.61 of this chapter, and sheets, suitably identified. If such data a notation shall be made that any such have already been submitted with an ingredient list is incomplete. earlier application, the present peti- (v) An assay method or other analyt- tion may incorporate it by specific ref- ical method, unless it serves no regu- erence to the earlier. If part of the data latory or compliance purpose and is have been submitted by the manufac- shown to fall within the exemption es- turer of the food additive as a master tablished in § 20.61 of this chapter. file, the petitioner may refer to the (2) The following data and informa- master file if and to the extent he ob- tion in a food additive petition are not tains the manufacturer’s written per- available for public disclosure unless mission to do so. The manufacturer they have been previously disclosed to may authorize specific reference to the the public as defined in § 20.81 of this data without disclosure to the peti- chapter or they relate to a product or tioner. Nothing herein shall prevent ingredient that has been abandoned reference to published data. and they no longer represent a trade (g) A petition shall be retained but secret or confidential commercial or fi- shall not be filed if any of the data pre- nancial information as defined in § 20.61 scribed by section 409(b) of the Act are of this chapter: lacking or are not set forth so as to be (i) Manufacturing methods or proc- readily understood. esses, including quality control proce- (h)(1) The following data and infor- dures. mation in a food additive petition are (ii) Production, sales, distribution, available for public disclosure, unless and similar data and information, ex- extraordinary circumstances are cept that any compilation of such data shown, after the notice of filing of the and information aggregated and pre- petition is published in the FEDERAL pared in a way that does not reveal REGISTER or, if the petition is not data or information which is not avail- promptly filed because of deficiencies able for public disclosure under this in it, after the petitioner is informed provision is available for public disclo- that it will not be filed because of the sure. deficiencies involved: (iii) Quantitative or semiquantita- (i) All safety and functionality data tive formulas. and information submitted with or in- (3) All correspondence and written corporated by reference in the petition. summaries of oral discussions relating
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to a food additive petition are avail- (j) The Commissioner may request a able for public disclosure in accordance full description of the methods used in, with the provisions of part 20 of this and the facilities and controls used for, chapter when the food additive regula- the production of the food additive, or tion is published in the FEDERAL REG- a sample of the food additive, articles ISTER. used as components thereof, or of the (4) For purposes of this regulation, food in which the additive is proposed safety and functionality data include to be used, at any time while a petition all studies and tests of a food additive is under consideration. The Commis- on animals and humans and all studies sioner shall specify in the request for a and tests on a food additive for iden- sample of the food additive, or articles tity, stability, purity, potency, per- used as components thereof, or of the formance, and usefulness. food in or on which the additive is pro- (i)(1) Within 15 days after receipt, the posed to be used, a quantity deemed Commissioner will notify the peti- adequate to permit tests of analytical tioner of acceptance or nonacceptance methods to determine quantities of the of a petition, and if not accepted the food additive present in foods for which reasons therefor. If accepted, the date it is intended to be used or adequate of the notification letter sent to peti- for any study or investigation reason- tioner becomes the date of filing for ably required with respect to the safety the purposes of section 409(b)(5) of the of the food additive or the physical or Act. If the petitioner desires, he may technical effect it produces. The date supplement a deficient petition after used for computing the 90-day limit for being notified regarding deficiencies. If the purposes of section 409(c)(2) of the the supplementary material or expla- Act shall be moved forward 1 day for nation of the petition is deemed ac- each day after the mailing date of the ceptable, petitioner shall be notified. request taken by the petitioner to sub- The date of such notification becomes mit the sample. If the information or the date of filing. If the petitioner does sample is requested a reasonable time not wish to supplement or explain the in advance of the 180 days, but is not petition and requests in writing that it submitted within such 180 days after be filed as submitted, the petition shall filing of the petition, the petition will be filed and the petitioner so notified. be considered withdrawn without prej- The date of such notification becomes udice. the date of filing. (k) If nonclinical laboratory studies (2) The Commissioner will publish in are involved, petitions filed with the the FEDERAL REGISTER within 30 days Commissioner under section 409(b) of from the date of filing of such petition, the act shall include, with respect to a notice of the filing, the name of the each nonclinical study contained in the petitioner, and a brief description of petition, either a statement that the the proposal in general terms. In the study has been, or will be, conducted in case of a food additive which becomes a compliance with the good laboratory component of food by migration from practice regulations as set forth in part packaging material, the notice shall 58 of this chapter, or, if any such study include the name of the migratory sub- was not conducted in compliance with stance, and where it is different from such regulations, a brief statement of that of one of the original components, the reason for the noncompliance. the name of the parent component, the (l) [Reserved] maximum quantity of the migratory (m) If clinical investigations involv- substance that is proposed for use in ing human subjects are involved, peti- food, and the physical or other tech- tions filed with the Commissioner nical effect which the migratory sub- under section 409(b) of the Act shall in- stance or its parent component is in- clude statements regarding each such tended to have in the packaging mate- clinical investigation relied upon in rial. A copy of the notice will be the petition that it either was con- mailed to the petitioner when the ducted in compliance with the require- original is forwarded to the FEDERAL ments for institutional review set forth REGISTER for publication. in part 56 of this chapter, or was not
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subject to such requirements in accord- forth in part 58 of this chapter, or, if ance with § 56.104 or § 56.105, and that it the study was not conducted in compli- was conducted in compliance with the ance with such regulations, a brief requirements for informed consent set statement of the reason for the non- forth in part 50 of this chapter. compliance. (n)(1) If intended uses of the food ad- [50 FR 7492, Feb. 22, 1985, as amended at 50 ditive include uses in meat, meat food 16668, Apr. 26, 1985] product, or poultry product subject to regulation by the U.S. Department of § 171.7 Withdrawal of petition without Agriculture (USDA) under the Poultry prejudice. Products Inspection Act (PPIA) (21 (a) In some cases the Commissioner U.S.C. 451 et seq.) or the Federal Meat will notify the petitioner that the peti- Inspection Act (FMIA) (21 U.S.C. 601 et tion, while technically complete, is in- seq.), FDA shall, upon filing of the peti- adequate to justify the establishment tion, forward a copy of the petition or of a regulation or the regulation re- relevant portions thereof to the Food quested by petitioner. This may be due Safety and Inspection Service, USDA, to the fact that the data are not suffi- for simultaneous review under the ciently clear or complete. In such PPIA and FMIA. cases, the petitioner may withdraw the (2) FDA will ask USDA to advise petition pending its clarification or the whether the proposed meat and poultry obtaining of additional data. This with- uses comply with the FMIA and PPIA, drawal will be without prejudice to a or if not, whether use of the substance future filing. Upon refiling, the time would be permitted in products under limitation will begin to run anew from USDA jurisdiction under specified con- the date of refiling. ditions or restrictions. (b) At any time before the order pro- [42 FR 14489, Mar. 15, 1977, as amended at 42 vided for in § 171.100(a) has been for- FR 15674, Mar. 22, 1977; 46 FR 8952, Jan. 27, warded to the FEDERAL REGISTER for 1981; 50 FR 7492, Feb. 22, 1985; 50 16668, Apr. 26, publication, the petitioner may with- 1985; 62 FR 40599, July 29, 1997; 65 FR 51763, draw the petition without prejudice to Aug. 25, 2000] a future filing. Upon refiling the time EFFECTIVE DATE NOTE: At 65 FR 51763, Aug. limitation will begin to run anew. 25, 2000, § 171.1 was amended in paragraph (a) by revising the first sentence, in paragraph § 171.8 Threshold of regulation for (c) in the petition by revising the introduc- substances used in food-contact ar- tory paragraph preceding paragraph A., and ticles. by adding paragraph (n). The revised and added text contains information collection Substances used in food-contact arti- and recordkeeping requirements and will not cles (e.g., food-packaging or food-proc- become effective until approval has been essing equipment) that migrate or that given by the Office of Management and may be expected to migrate into food Budget. at negligible levels may be reviewed under § 170.39 of this chapter. The Food § 171.6 Amendment of petition. and Drug Administration will exempt After a petition has been filed, the substances whose uses it determines petitioner may submit additional in- meet the criteria in § 170.39 of this formation or data in support thereof. chapter from regulation as food addi- In such cases, if the Commissioner de- tives and, therefore, a food additive pe- termines that the additional informa- tition will not be required for the ex- tion or data amount to a substantive empted use. amendment, the petition as amended will be given a new filing date, and the [60 FR 36596, July 17, 1995] time limitation will begin to run anew. If nonclinical laboratory studies are in- Subpart B—Administrative Actions volved, additional information and on Applications data submitted in support of filed peti- tions shall include, with respect to § 171.100 Regulation based on petition. each nonclinical study, either a state- (a) The Commissioner will forward ment that the study was conducted in for publication in the FEDERAL REG- compliance with the requirements set ISTER, within 90 days after filing of the
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petition (or within 180 days if the time § 171.130 Procedure for amending and is extended as provided for in section repealing tolerances or exemptions 409(c)(2) of the Act), a regulation pre- from tolerances. scribing the conditions under which (a) The Commissioner, on his own the food additive may be safely used initiative or on the petition of any in- (including, but not limited to, speci- terested person, pursuant to part 10 of fications as to the particular food or this chapter, may propose the issuance classes of food in or on which such ad- of a regulation amending or repealing a ditive may be used, the maximum regulation pertaining to a food additive quantity that may be used or per- or granting or repealing an exception mitted to remain in or on such food, for such additive. the manner in which such additive may (b) Any such petition shall include an be added to or used in or on such food, assertion of facts, supported by data, and any directions or other labeling or showing that new information exists packaging requirements for such addi- with respect to the food additive or tive deemed necessary by him to assure that new uses have been developed or the safety of such use), and prior to the old uses abandoned, that new data are available as to toxicity of the chem- forwarding of the order to the FEDERAL ical, or that experience with the exist- REGISTER for publication shall notify ing regulation or exemption may jus- the petitioner of such order and the tify its amendment or repeal. New data reasons for such action; or by order shall be furnished in the form specified deny the petition, and shall notify the in §§ 171.1 and 171.100 for submitting pe- petitioner of such order and of the rea- titions. sons for such action. (b) The regulation shall describe the [42 FR 14491, Mar. 15, 1977, as amended at 42 conditions under which the substance FR 15674, Mar. 22, 1977] may be safely used in any meat prod- uct, meat food product, or poultry PART 172—FOOD ADDITIVES PER- product subject to the Federal Meat In- MITTED FOR DIRECT ADDITION TO spection Act (FMIA) (21 U.S.C. 601 et FOOD FOR HUMAN CONSUMP- seq.) or the Poultry Products Inspec- TION tion Act (PPIA) (21 U.S.C. 451 et seq.). (c) If the Commissioner determines Subpart A—General Provisions that additional time is needed to study Sec. and investigate the petition, he shall 172.5 General provisions for direct food ad- by written notice to the petitioner ex- ditives. tend the 90-day period for not more than 180 days after the filing of the pe- Subpart B—Food Preservatives tition. 172.105 Anoxomer. 172.110 BHA. [42 FR 14489, Mar. 15, 1977, as amended at 65 172.115 BHT. FR 51763, Aug. 25, 2000] 172.120 Calcium disodium EDTA. 172.130 Dehydroacetic acid. § 171.102 Effective date of regulation. 172.133 Dimethyl dicarbonate. A regulation published in accordance 172.135 Disodium EDTA. 172.140 Ethoxyquin. with § 171.100(a) shall become effective 172.145 Heptylparaben. upon publication in the FEDERAL REG- 172.150 4-Hydroxymethyl-2,6-di-tert-butyl- ISTER. phenol. 172.155 Natamycin (pimaricin). § 171.110 Procedure for objections and 172.160 Potassium nitrate. hearings. 172.165 Quaternary ammonium chloride combination. Objections and hearings relating to 172.170 Sodium nitrate. food additive regulations under section 172.175 Sodium nitrite. 409 (c), (d), or (h) of the Act shall be 172.177 Sodium nitrite used in processing governed by part 12 of this chapter. smoked chub. 172.180 Stannous chloride. [42 FR 14491, Mar. 15, 1977, as amended at 42 172.185 TBHQ. FR 15674, Mar. 22, 1977] 172.190 THBP.
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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. 172.695 Xanthan gum. 172.255 Polyacrylamide. 172.260 Oxidized polyethylene. Subpart H—Other Specific Usage Additives 172.270 Sulfated butyl oleate. 172.275 Synthetic paraffin and succinic de- 172.710 Adjuvants for pesticide use dilu- rivatives. tions. 172.280 Terpene resin. 172.712 1,3–Butylene glycol. 172.715 Calcium lignosulfonate. Subpart D—Special Dietary and Nutritional 172.720 Calcium lactobionate. Additives 172.723 Epoxidized soybean oil. 172.725 Gibberellic acid and its potassium 172.310 Aluminum nicotinate. salt. 172.315 Nicotinamide-ascorbic acid complex. 172.730 Potassium bromate. 172.320 Amino acids. 172.735 Glycerol ester of wood rosin. 172.325 Bakers yeast protein. 172.755 Stearyl monoglyceridyl citrate. 172.330 Calcium pantothenate, calcium chlo- 172.765 Succistearin (stearoyl propylene gly- ride double salt. col hydrogen succinate). 172.335 D-Pantothenamide. 172.770 Ethylene oxide polymer. 172.340 Fish protein isolate. 172.775 Methacrylic acid-divinylbenzene co- 172.345 Folic acid (folacin). polymer. 172.350 Fumaric acid and salts of fumaric acid. Subpart I—Multipurpose Additives 172.365 Kelp. 172.800 Acesulfame potassium. 172.370 Iron-choline citrate complex. 172.802 Acetone peroxides. 172.372 N–Acetyl–L–methionine. 172.804 Aspartame. 172.375 Potassium iodide. 172.806 Azodicarbonamide. 172.385 Whole fish protein concentrate. 172.808 Copolymer condensates of ethylene 172.395 Xylitol. oxide and propylene oxide. 172.399 Zinc methionine sulfate. 172.809 Curdlan. 172.810 Dioctyl sodium sulfosuccinate. Subpart E—Anticaking Agents 172.811 Glyceryl tristearate. 172.812 Glycine. 172.410 Calcium silicate. 172.814 Hydroxylated lecithin. 172.430 Iron ammonium citrate. 172.816 Methyl glucoside-coconut oil ester. 172.480 Silicon dioxide. 172.818 Oxystearin. 172.490 Yellow prussiate of soda. 172.820 Polyethylene gylcol (mean molec- ular weight 200–9,500). Subpart F—Flavoring Agents and Related 172.822 Sodium lauryl sulfate. Substances 172.824 Sodium mono- and dimethyl naph- thalene sulfonates. 172.510 Natural flavoring substances and 172.826 Sodium stearyl fumarate. natural substances used in conjunction 172.828 Acetylated monoglycerides. with flavors. 172.830 Succinylated monoglycerides. 172.515 Synthetic flavoring substances and 172.831 Sucralose. adjuvants. 172.832 Monoglyceride citrate. 172.520 Cocoa with dioctyl sodium sulfo- 172.833 Sucrose acetate isobutyrate (SAIB). succinate for manufacturing. 172.834 Ethoxylated mono- and diglycerides. 172.530 Disodium guanylate. 172.836 Polysorbate 60. 172.535 Disodium inosinate. 172.838 Polysorbate 65. 172.540 DL–Alanine. 172.840 Polysorbate 80. 172.560 Modified hop extract. 172.841 Polydextrose. 172.575 Quinine. 172.842 Sorbitan monostearate. 172.580 Safrole-free extract of sassafras. 172.844 Calcium stearoyl-2-lactylate. 172.585 Sugar beet extract flavor base. 172.846 Sodium stearoyl lactylate. 172.590 Yeast-malt sprout extract. 172.848 Lactylic esters of fatty acids.
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172.850 Lactylated fatty acid esters of glyc- and is prepared and handled as a food erol and propylene glycol. ingredient. 172.852 Glyceryl-lacto esters of fatty acids. (b) The existence of a regulation pre- 172.854 Polyglycerol esters of fatty acids. 172.856 Propylene glycol mono- and diesters scribing safe conditions of use for a of fats and fatty acids. food additive shall not be construed to 172.858 Propylene glycol alginate. relieve the use of the substance from 172.859 Sucrose fatty acid esters. compliance with any other provision of 172.860 Fatty acids. the Act. 172.861 Cocoa butter substitute from coco- (c) The existence of any regulation nut oil, palm kernel oil, or both oils. 172.862 Oleic acid derived from tall oil fatty prescribing safe conditions of use for a acids. nutrient substance does not constitute 172.863 Salts of fatty acids. a finding that the substance is useful 172.864 Synthetic fatty alcohols. or required as a supplement to the diet 172.866 Synthetic glycerin produced by the of humans. hydrogenolysis of carbohydrates. 172.867 Olestra. 172.868 Ethyl cellulose. Subpart B—Food Preservatives 172.870 Hydroxypropyl cellulose. 172.872 Methyl ethyl cellulose. § 172.105 Anoxomer. 172.874 Hydroxypropyl methylcellulose. 172.876 Castor oil. Anoxomer as identified in this sec- 172.878 White mineral oil. tion may be safely used in accordance 172.880 Petrolatum. with the following conditions: 172.882 Synthetic isoparaffinic petroleum (a) Anoxomer is 1,4-benzenediol, 2- hydrocarbons. (1,1-dimethylethyl)-polymer with 172.884 Odorless light petroleum hydro- diethenylbenzene, 4-(1,1-dimethyl- carbons. ′ 172.886 Petroleum wax. ethyl)phenol, 4- methoxyphenol, 4,4 -(1- 172.888 Synthetic petroleum wax. methylethylidene)bis(phenol) and 4- 172.890 Rice bran wax. methylphenol (CAS Reg. No. 60837–57–2) 172.892 Food starch-modified. prepared by condensation polymeriza- 172.894 Modified cottonseed products in- tion of divinylbenzene (m- and p-) with tended for human consumption. tert-butylhydroquinone, tert-butyl- 172.896 Dried yeasts. phenol, hydroxyanisole, p-cresol and 172.898 Bakers yeast glycan. 4,4′-isopropylidenediphenol. AUTHORITY: 21 U.S.C. 321, 341, 342, 348, 371, (b) The polymeric antioxidant meets 379e. the following specifications: SOURCE: 42 FR 14491, Mar. 15, 1977, unless (1) Polymer, not less than 98.0 per- otherwise noted. cent as determined by an ultraviolet EDITORIAL NOTE: Nomenclature changes to method entitled ‘‘Ultraviolet Assay, part 172 appear at 61 FR 14482, Apr. 2, 1996. ‘‘1982, which is incorporated by ref- erence. Copies are available from the Subpart A—General Provisions Center for Food Safety and Applied Nu- trition (HFS–200), Food and Drug Ad- § 172.5 General provisions for direct ministration, 200 C St. SW., Wash- food additives. ington, DC 20204, or available for in- (a) Regulations prescribing condi- spection at the Office of the Federal tions under which food additive sub- Register, 800 North Capitol Street, stances may be safely used predicate NW., suite 700, Washington, DC 20408. usage under conditions of good manu- (2) Molecular weight: Total mono- facturing practice. For the purposes of mers, dimers and trimers below 500 not this part, good manufacturing practice more than 1 percent as determined by a shall be defined to include the fol- method entitled ‘‘Low Molecular lowing restrictions. Weight Anoxomer Analysis,’’ 1982, (1) The quantity of the substance which is incorporated by reference. added to food does not exceed the Copies are available from the Center amount reasonably required to accom- for Food Safety and Applied Nutrition plish its intended physical, nutritive, (HFS–200), Food and Drug Administra- or other technical effect in food. tion, 200 C St. SW., Washington, DC (2) Any substance intended for use in 20204, or available for inspection at the or on food is of appropriate food grade Office of the Federal Register, 800
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North Capitol Street, NW., suite 700, (1) The label of any market package Washington, DC 20408. of the additive shall bear, in addition (3) Phenol content: Not less than 3.2 to the other information required by milliequivalent/gram and not more the Act, the name of the additive. than 3.8 milliequivalent/gram as deter- (2) When the additive is marketed in mined by a method entitled ‘‘Total a suitable carrier, in addition to meet- Phenols,’’ 1982, which is incorporated ing the requirement of paragraph (c)(1) by reference. Copies are available from of this section, the label shall declare the Center for Food Safety and Applied the percentage of the additive in the Nutrition (HFS–200), Food and Drug mixture. Administration, 200 C St. SW., Wash- (3) The label or labeling of dry mixes ington, DC 20204, or available for in- for beverages and desserts shall bear spection at the Office of the Federal adequate directions for use to provide Register, 800 North Capitol Street, that beverages and desserts prepared NW., suite 700, Washington, DC 20408. from the dry mixes contain no more (4) Heavy metals as lead (as Pb), not than 2 parts per million BHA. more than 10 parts per million. Arsenic (as As), not more than 3 parts per mil- § 172.115 BHT. lion. Mercury (as Hg), not more than 1 The food additive BHT (butylated hy- part per million. droxytoluene), alone or in combination (c) Anoxomer may be safely used as with other antioxidants permitted in an antioxidant in food at a level of not this subpart B may be safely used in or more than 5,000 parts per million based on specified foods, as follows: on fat and oil content of the food. (a) The BHT meets the following [48 FR 18798, Apr. 26, 1983, as amended at 54 specification: Assay (total BHT) 99 per- FR 24896, June 12, 1989] cent minimum. (b) The BHT is used alone or in com- § 172.110 BHA. bination with BHA, as an antioxidant The food additive BHA (butylated hy- in foods, as follows: droxyanisole) alone or in combination Limitations with other antioxidants permitted in (total BHA Food and BHT) food for human consumption in this parts per subpart B may be safely used in or on million specified foods, as follows: Dehydrated potato shreds ...... 50 (a) The BHA meets the following Dry breakfast cereals ...... 50 specification: Emulsion stabilizers for shortenings ...... 200 Potato flakes ...... 50 Assay (total BHA), 98.5 percent minimum. Potato granules ...... 10 Melting point 48 °C minimum. Sweetpotato flakes ...... 50
(b) The BHA is used alone or in com- (c) To assure safe use of the additive: bination with BHT, as an antioxidant (1) The label of any market package in foods, as follows: of the additive shall bear, in addition Limitations to the other information required by (total BHA the Act, the name of the additive. Food and BHT) parts per (2) When the additive is marketed in million a suitable carrier, in addition to meet- ing the requirement of paragraph (c)(1) Dehydrated potato shreds ...... 50 Active dry yeast ...... 1 1,000 of this section, the label shall declare Beverages and desserts prepared from dry the percentage of the additive in the mixes ...... 1 2 mixture. Dry breakfast cereals ...... 50 Dry diced glazed fruit ...... 1 32 § 172.120 Calcium disodium EDTA. Dry mixes for beverages and desserts ...... 1 90 Emulsion stabilizers for shortenings ...... 200 The food additive calcium disodium Potato flakes ...... 50 EDTA (calcium disodium ethylene- Potato granules ...... 10 Sweet potato flakes ...... 50 diaminetetraacetate) may be safely used in designated foods for the pur- 1 BHA only. poses and in accordance with the condi- (c) To assure safe use of the additive: tions prescribed, as follows:
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(a) The additive contains a minimum (2) With disodium EDTA (disodium of 99 percent by weight of either the di- ethylenediaminetetraacetate) in the hydrate C10H12O8N2CaNa2·2H2O or the following foods at not to exceed, in trihydrate C10H12O8N2CaNa2·3H2O, or combination, the levels prescribed, cal- any mixture of the two. culated as anhydrous C10H12O8N2CaNa2: (b) It is used or intended for use as Limita- follows: tion (1) Alone, in the following foods at Food (parts Use per mil- not to exceed the levels prescribed, cal- lion) culated as the anhydrous compound: Dressings, nonstandardized .... 75 Preservative. Limita- French dressing ...... 75 Do. tion Mayonnaise ...... 75 Do. Food (parts Use Salad dressing ...... 75 Do. per mil- Sandwich spread ...... 100 Do. lion) Sauces ...... 75 Do. Cabbage, pickled ...... 220 Promote color, flavor, and texture retention. (c) To assure safe use of the additive: Canned carbonated soft 33 Promote flavor reten- (1) The label and labeling of the addi- drinks. tion. Canned white potatoes 110 Promote color retention. tive container shall bear, in addition to Clams (cooked canned) 340 Promote color retention. the other information required by the Crabmeat (cooked 275 Retard struvite forma- Act, the name of the additive. canned). tion; promote color (2) The label or labeling of the addi- retention. Cucumbers pickled ...... 220 Promote color, flavor, tive container shall bear adequate use and texture retention. directions to provide a final food prod- Distilled alcoholic bev- 25 Promote stability of uct that complies with the limitations erages. color, flavor, and/or product clarity. provided in paragraph (b) of this sec- Dressings, nonstandard- 75 Preservative. tion. ized. (d) In the standardized foods listed in Dried lima beans 310 Promote color retention. (cooked canned). paragraph (b) of this section, the addi- Egg product that is 1 200 Preservative. tives are used only in compliance with hard-cooked and con- the applicable standards of identity for sists, in a cylindrical such foods. shape, of egg white with an inner core of [42 FR 14491, Mar. 15, 1977, as amended at 48 egg yolk. FR 10815, Mar. 15, 1983; 58 FR 52222, Oct. 7, Fermented malt bev- 25 Antigushing agent. erages. 1993; 60 FR 33710, June 29, 1995; 65 FR 48379, French dressing ...... 75 Preservative. Aug. 8, 2000] Legumes (all cooked 365 Promote color retention. canned, other than § 172.130 Dehydroacetic acid. dried lima beans, pink beans, and red The food additive dehydroacetic acid beans). and/or its sodium salt may be safely Mayonnaise ...... 75 Do. used in accordance with the following Mushrooms (cooked 200 Promote color retention. canned). prescribed conditions: Oleomargarine ...... 75 Preservative. (a) The food additive meets the fol- Pecan pie filling ...... 100 Promote color retention. lowing specifications: Pink beans (cooked 165 Promote color retention. canned). Dehydroacetic acid: Melting point, 109 °C–111 Potato salad ...... 100 Preservative. °C; assay, minimum 98 percent (dry basis). Processed dry pinto 800 Promote color retention. Sodium salt of dehydroacetic acid: Assay, beans. Red beans (cooked 165 Promote color retention. minimum 98 percent (dry basis). canned). (b) It is used or intended for use as a Salad dressing ...... 75 Preservative. Sandwich spread ...... 100 Do. preservative for cut or peeled squash, Sauces ...... 75 Do. and is so used that no more than 65 Shrimp (cooked 250 Retard struvite forma- parts per million expressed as dehydro- canned). tion; promote color retention. acetic acid remains in or on the pre- Spice extractives in 60 Promote color and fla- pared squash. soluble carriers. vor retention. (c) The label or labeling of any pack- Spreads, artificially col- 100 Promote color retention. ored and lemon-fla- age of the additive intended for use in vored or orange-fla- food shall bear adequate directions for vored. use to insure compliance with this sec- 1 By weight of egg yolk portion. tion.
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§ 172.133 Dimethyl dicarbonate. with 5 U.S.C. 552(a). Copies are avail- able from the Center for Food Safety Dimethyl dicarbonate (CAS Reg. No. and Applied Nutrition (HFS–200), 200 C 4525–33–1) may be safely used in food in Street SW., Washington, DC 20204, or accordance with the following pre- available for inspection at the Office of scribed conditions: the Federal Register, 800 North Capitol (a) The additive meets the following Street, NW., suite 700, Washington, DC specifications: 20408. (1) The additive has a purity of not (b) The additive is used or intended less than 99.8 percent as determined by for use as a microbial control agent in the following titration method: the following beverages under normal PRINCIPLES OF METHOD circumstances of bottling, canning, or other forms of final packaging, where Dimethyl dicarbonate (DMDC) is mixed with excess diisobutylamine with which it the viable microbial load has been re- reacts quantitatively. The excess amine is duced to 500 microorganisms per milli- backtitrated with acid. liter or less by current good manufac- turing practices such as heat treat- APPARATUS ment, filtration, or other technologies 250-milliliter (mL) Beaker prior to the use of dimethyl dicar- 100-mL Graduate cylinder bonate: 25-mL Pipette (1) In wine, dealcoholized wine, and 10-mL Burette (automatic, eg., Metrohm bu- low alcohol wine in an amount not to rette) exceed 200 parts per million. Stirrer Device for potentiometric titration (2) In ready-to-drink teas in an Reference electrode amount not to exceed 250 parts per mil- Glass electrode lion. unflavored beverages containing added electrolytes (5–20 milli- REAGENTS equivalents/liter sodium ion (Na+) and Acetone, analytical-grade 3–7 milliequivalents/liter potassium ion Solution of 1 N diisobutylamine in chloro- (K+)) in an amount not to exceed 250 benzene, distilled parts per million. 1 N Acetic Acid (4) In carbonated, dilute beverages PROCEDURE containing juice, fruit flavor, or both, with juice content not to exceed 50 per- Accurately weigh in about 2 grams of the cent, in an amount not to exceed 250 sample (W) and dissolve in 100 mL acetone. parts per million. Add accurately 25 mL of the 1 N diisobutyl- amine solution by pipette and allow to stand (c) To ensure the safe use of the food for 5 minutes. Subsequently, titrate the re- additive, the label of the package con- action mixture potentiometrically with 1 N taining the additive shall bear, in addi- hydrochloric acid (consumption=a mL) while tion to other information required by stirring. For determining the blank con- the Federal Food, Drug, and Cosmetic sumption, carry out the analysis without a Act: sample (consumption=b mL). (1) The name of the additive ‘‘di- CALCULATION methyl dicarbonate.’’ (2) The intended use of the additive. (3) Adequate directions for use to en- ()ba− ×13. 4 = % DMDC sure compliance with this section. W [53 FR 41329, Oct. 21, 1988, as amended at 58 NOTE: For adding the diisobutylamine so- FR 6091, Jan. 26, 1993; 59 FR 5319, Feb. 4, 1994; lution, always use the same pipette and wait 61 FR 14245, Apr. 1, 1996; 61 FR 26788, May 29, for a further three drops to fall when the 1996; 66 FR 13653, Mar. 7, 2001] flow has stopped. (2) The additive contains not more § 172.135 Disodium EDTA. than 2,000 ppm (0.2 percent) dimethyl The food additive disodium EDTA carbonate as determined by a method (disodium ethylenediaminetetraace- entitled ‘‘Gas Chromatography Method tate) may be safely used in designated for Dimethyl Carbonate Impurity in foods for the purposes and in accord- Dimethyl Dicarbonate,’’ whichis incor- ance with the following prescribed con- porated by reference in accordance ditions:
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(a) The additive contains a minimum (3) Alone, as a sequestrant in the of 99 percent disodium ethylenedia- nonnutritive sweeteners that are listed minetetraacetate dihydrate in § 180.37 of this chapter and that, in (C10H14O8N2Na2·2H2O). addition, are designed for aqueous solu- (b) It is used or intended for use as tion: Provided, That the amount of the follows: additive, calculated as anhydrous cal- (1) Alone, in the following foods at cium disodium EDTA, does not exceed not to exceed the levels prescribed, cal- 0.1 percent by weight of the dry non- culated as anhydrous calcium disodium nutritive sweetener. EDTA: (c) To assure the safe use of the addi- tive: Limita- (1) The label and labeling of the addi- tion Food (parts Use tive container shall bear, in addition to per mil- the other information required by the lion) act, the name of the additive. Aqueous multivitamin prep- 150 With iron salts as a (2) The label or labeling of the addi- arations. stabilizer for vita- tive container shall bear adequate use min B 12 in liquid multivitamin prep- directions to provide a final food prod- arations. uct that complies with the limitations Canned black-eyed peas .... 145 Promote color re- provided in paragraph (b) of this sec- tention. tion. Canned kidney beans ...... 165 Preservative. Canned strawberry pie filling 500 Promote color re- (d) In the standardized foods listed in tention. paragraphs (b) (1) and (2) of this section Cooked sausage ...... 36 As a cure accel- the additives are used only in compli- erator with so- dium ascorbate ance with the applicable standards of or ascorbic acid. identity for such foods. Dressings, nonstandardized 75 Preservative. French dressing ...... 75 Do. [42 FR 14491, Mar. 15, 1977, as amended at 65 Frozen white potatoes in- 100 Promote color re- FR 48379, Aug. 8, 2000] cluding cut potatoes. tention. Gefilte fish balls or patties in 1 50 Inhibit discoloration. § 172.140 Ethoxyquin. packing medium. Legumes (all cooked 165 Promote color re- (a) Ethoxyquin (1,2-dihydro-6-ethoxy- canned, other than black- tention. 2,2,4-trimethylquinoline) may be safely eyed peas). used as an antioxidant for preservation Mayonnaise ...... 75 Preservative. of color in the production of chili pow- Ready-to-eat cereal prod- 2 315 Promote color re- ucts containing dried ba- tention. der, paprika, and ground chili at levels nanas. not in excess of 100 parts per million. Salad dressing ...... 75 Preservative. (b) In order to provide for the safe Sandwich spread ...... 100 Do. use of the additive in feed prepared in Sauces ...... 75 Do. accordance with §§ 573.380 and 573.400 of 1 Based on total weight of finished product including packing medium. this chapter, tolerances are established 2 In dried banana component of cereal product. for residues of ethoxyquin in or on edi- (2) With calcium disodium EDTA ble products of animals as follows: (calcium disodium ethylenediamine- 5 parts per million in or on the uncooked fat tetraacetate; calcium disodium of meat from animals except poultry. (ethylenedinitrilo) tetraacetate), in the 3 parts per million in or on the uncooked following foods at not to exceed, in liver and fat of poultry. combination, the levels prescribed, cal- 0.5 part per million in or on the uncooked muscle meat of animals. culated as anhydrous C10H12O8N2CaNa2: 0.5 part per million in poultry eggs. Zero in milk. Limita- tion Food (parts Use § 172.145 Heptylparaben. per mil- lion) (a) The food additive heptylparaben is the chemical n-heptyl p-hydroxy- Dressings, nonstandardized 75 Preservative. French dressing ...... 75 Do. benzoate. Mayonnaise ...... 75 Do. (b) It may be safely used to inhibit Salad dressing ...... 75 Do. microbiological spoilage in accordance Sandwich spread ...... 100 Do. with the following prescribed condi- Sauces ...... 75 Do. tions:
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(1) In fermented malt beverages in Food Safety and Applied Nutrition, amounts not to exceed 12 parts per mil- Food and Drug Administration, 200 C lion. St. SW., Washington, DC 20204, or may (2) In noncarbonated soft drinks and be examined at the Center for Food fruit-based beverages in amounts not Safety and Applied Nutrition’s Li- to exceed 20 parts per million, when brary, 200 C St. SW., rm. 3321, Wash- standards of identity established under ington, DC, or at the Office of the Fed- section 401 of the Act (21 U.S.C. 341) do eral Register, 800 North Capitol St. not preclude such use. NW., suite 700, Washington, DC.
§ 172.150 4-Hydroxymethyl-2,6-di-tert- [47 FR 26823, June 22, 1982, as amended at 50 butylphenol. FR 49536, Dec. 3, 1985; 63 FR 66015, Dec. 1, 1998; 66 FR 13847, Mar. 8, 2001] The food additive 4-hydroxymethyl- 2,6-di-tert-butylphenol may be safely § 172.160 Potassium nitrate. used in food in accordance with the fol- The food additive potassium nitrate lowing prescribed conditions: may be safely used as a curing agent in (a) The additive has a solidification the processing of cod roe, in an amount ° ° point of 140 C–141 C. not to exceed 200 parts per million of (b) The additive is used as an anti- the finished roe. oxidant alone or in combination with other permitted antioxidants. § 172.165 Quaternary ammonium chlo- (c) The total amount of all anti- ride combination. oxidants added to such food shall not The food additive, quaternary ammo- exceed 0.02 percent of the oil or fat con- nium chloride combination, may be tent of the food, including the essential safely used in food in accordance with (volatile) oil content of the food. the following conditions: (a) The additive contains the fol- § 172.155 Natamycin (pimaricin). lowing compounds: n-dodecyl dimethyl (a) Natamycin (CAS Reg. No. 7681–93– benzyl ammonium chloride (CAS Reg. 8), also known as pimaricin, is a pol- No. 139–07–1); n-dodecyl dimethyl ethyl- yene macrolide antimycotic substance benzyl ammonium chloride (CAS Reg. possessing an empirical formula of No. 27479–28–3); n-hexadecyl dimethyl C33H47NO13 and a molecular weight of benzyl ammonium chloride (CAS Reg. 665.7. No. 122–18–9); n-octadecyl dimethyl (b) The additive shall conform to the benzyl ammonium chloride (CAS Reg. following specifications: No. 122–19–0); n-tetradecyl dimethyl Purity: 97 percent ±2 percent on an anhy- benzyl ammonium chloride (CAS Reg. drous basis. No. 139–08–2); n-tetradecyl dimethyl Arsenic: Not more than 1 part per million. ethylbenzyl ammonium chloride (CAS Heavy metals (as Pb): Not more than 20 parts Reg. No. 27479–29–4). per million. (b) The additive meets the following (c) The additive may be applied on specifications: pH (5 percent active so- cheese, as an antimycotic, in amounts lution) 7.0–8.0; total amines, maximum not to exceed 20 milligrams per kilo- 1 percent as combined free amines and gram (20 parts per million) in the fin- amine hydrochlorides. ished product as determined by Inter- (c) The additive is used as an anti- national Dairy Federation (IDF) Stand- microbial agent, as defined in ard 140A:1992, ‘‘Cheese and Cheese § 170.3(o)(2) of this chapter, in raw sugar Rind–Determination of Natamycin cane juice. It is added prior to clari- Content–Method by Molecular Absorp- fication when further processing of the tion Spectrometry and by High-Per- sugar cane juice must be delayed. formance Liquid Chromatography,’’ (d) The additive is applied to the which is incorporated by reference. The sugar juice in the following quantities, Director of the Office of the Federal based on the weight of the raw cane: Register approves this incorporation Parts per by reference in accordance with 5 Component million U.S.C. 552(a) and 1 CFR part 51. Copies n-Dodecyl dimethyl benzyl ammonium chloride 0.25–1.0 are available from the Division of n-Dodecyl dimethyl ethylbenzyl ammonium Product Policy (HFS–206), Center for chloride ...... 3.4–13.5
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or of a mixture containing the addi- Component Parts per million tive, shall bear the statement ‘‘Keep n-Hexadecyl dimethyl benzyl ammonium chlo- out of the reach of children’’. ride ...... 1.5–6.0 n-Octadecyl dimethyl benzyl ammonium chlo- § 172.175 Sodium nitrite. ride ...... 0.25–1.0 n-Tetradecyl dimethyl benzyl ammonium chlo- The food additive sodium nitrite may ride ...... 3.0–12.0 be safely used in or on specified foods n-Tetradecyl dimethyl ethylbenzyl ammonium in accordance with the following pre- chloride ...... 1.6–6.5 scribed conditions: (a) It is used or intended for use as [50 FR 3890, Jan. 29, 1985] follows: § 172.170 Sodium nitrate. (1) As a color fixative in smoked cured tunafish products so that the The food additive sodium nitrate level of sodium nitrite does not exceed may be safely used in or on specified 10 parts per million (0.001 percent) in foods in accordance with the following the finished product. prescribed conditions: (2) As a preservative and color fixa- (a) It is used or intended for use as tive, with or without sodium nitrate, follows: in smoked, cured sablefish, smoked, (1) As a preservative and color fixa- cured salmon, and smoked, cured shad tive, with or without sodium nitrite, in so that the level of sodium nitrite does smoked, cured sablefish, smoked, cured not exceed 200 parts per million and the salmon, and smoked, cured shad, so level of sodium nitrate does not exceed that the level of sodium nitrate does 500 parts per million in the finished not exceed 500 parts per million and the product. level of sodium nitrite does not exceed 200 parts per million in the finished (3) As a preservative and color fixa- product. tive, with sodium nitrate, in meat-cur- (2) As a preservative and color fixa- ing preparations for the home curing of tive, with or without sodium nitrite, in meat and meat products (including meat-curing preparations for the home poultry and wild game), with directions curing of meat and meat products (in- for use which limit the amount of so- cluding poultry and wild game), with dium nitrite to not more than 200 parts directions for use which limit the per million in the finished meat prod- amount of sodium nitrate to not more uct, and the amount of sodium nitrate than 500 parts per million in the fin- to not more than 500 parts per million ished meat product and the amount of in the finished meat product. sodium nitrite to not more than 200 (b) To assure safe use of the additive, parts per million in the finished meat in addition to the other information re- product. quired by the Act: (b) To assure safe use of the additive, (1) The label of the additive or of a in addition to the other information re- mixture containing the additive shall quired by the Act: bear: (1) The label of the additive or of a (i) The name of the additive. mixture containing the additive shall (ii) A statement of the concentration bear: of the additive in any mixture. (i) The name of the additive. (2) If in a retail package intended for (ii) A statement of the concentration household use, the label and labeling of of the additive in any mixture. the additive, or of a mixture con- (2) If in a retail package intended for taining the additive, shall bear ade- household use, the label and labeling of quate directions for use to provide a the additive, or of a mixture con- final food product which complies with taining the additive, shall bear ade- the limitations prescribed in paragraph quate directions for use to provide a (a) of this section. final food product that complies with (3) If in a retail package intended for the limitations prescribed in paragraph household use, the label of the addi- (a) of this section. tive, or of a mixture containing the ad- (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’’.
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§ 172.177 Sodium nitrite used in proc- § 172.180 Stannous chloride. essing smoked chub. The food additive stannous chloride The food additive sodium nitrite may may be safely used for color retention be safely used in combination with salt in asparagus packed in glass, with lids (NaCl) to aid in inhibiting the out- lined with an inert material, in an growth and toxin formation from Clos- amount not to exceed 20 parts per mil- tridium botulinum type E in the com- lion calculated as tin (Sn). mercial processing of smoked chub in accordance with the following pre- § 172.185 TBHQ. scribed conditions: The food additive TBHQ, which is the (a) All fish in smoking establish- chemical 2-(1,1-dimethylethyl)-1,4-benz- ments shall be clean and wholesome enediol (Chemical Abstracts Service and shall be expeditiously processed, Registry Number 1948–33–0), also known packed, and stored under adequate san- as tertiary butylhydroquinone, may be itary conditions in accordance with safely used in food in accordance with good manufacturing practice. the following prescribed conditions: (b) The brining procedure is con- (a) The food additive has a melting trolled in such a manner that the point of 126.5 °C–128.5 °C. water phase portion of the edible por- (b) It is used as an antioxidant alone tion of the finished smoked product has or in combination with BHA and/or a salt (NaCl) content of not less than BHT. 3.5 percent, as measured in the loin (c) The total antioxidant content of a muscle, and the sodium nitrite content food containing the additive will not of the edible portion of the finished exceed 0.02 percent of the oil or fat con- smoked product is not less than 100 tent of the food, including the essential parts per million and not greater than (volatile) oil content of the food. 200 parts per million, as measured in the loin muscle. § 172.190 THBP. (c) Smoked chub shall be heated by a The food additive THBP (2,4,5-tri- controlled heat process which provides hydroxybutyrophenone) may be safely a monitoring system positioned in as used in food in accordance with the fol- many strategic locations in the smoke- lowing prescribed conditions: house as necessary to assure a contin- (a) The food additive has a melting uous temperature throughout each fish point of 149 °C–153 °C. of at least 160 °F for a minimum of 30 (b) It is used as an antioxidant alone minutes. or in combination with other permitted (d) The finished product shall be antioxidants. cooled to a temperature of 50 °F or (c) The total antioxidant content of a below within 3 hours after smoking and food containing the additive will not further cooled to a temperature of 38 °F exceed 0.02 percent of the oil or fat con- or below within 12 hours after smoking. tent of the food, including the essential A temperature of 38 °F or below shall (volatile) oil content of the food. be maintained during all subsequent storage and distribution. All shipping containers, retail packages, and ship- Subpart C—Coatings, Films and ping records shall indicate with appro- Related Substances priate notice the perishable nature of the product and specify that the prod- § 172.210 Coatings on fresh citrus fruit. uct shall be held under refrigeration (38 Coatings may be applied to fresh cit- °F or below) until consumed. rus fruit for protection of the fruit in (e) To assure safe use of the additive: accordance with the following condi- (1) The label and labeling of the addi- tions: tive container shall bear, in addition to (a) The coating is applied in the min- the other information required by the imum amount required to accomplish Act, the name of the additive. the intended effect. (2) The label or labeling of the addi- (b) The coating may be formulated tive container shall bear adequate di- from the following components, each rections to assure use in compliance used in the minimum quantity required with the provisions of this section. to accomplish the intended effect:
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(1) Substances generally recognized (2) One or more of the following: as safe for the purpose or previously sanctioned for the purpose.
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; saponifica- tion 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.
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. heavy coal-tar solvent naphtha meet- ing the following specifications: The food additive coumarone-indene (1) It is a mixture of indene, indan resin may be safely used on grapefruit, (hydrindene), substituted benzenes, and lemons, limes, oranges, tangelos, and related compounds. tangerines in accordance with the fol- (2) It contains no more than 0.25 per- lowing prescribed conditions: cent tar bases. (a) The food additive is manufactured (3) 95 percent distills in the range 167 by the polymerization of a crude, °C–184 °C.
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(b) The food additive meets the fol- cent by weight in an aqueous emulsion lowing specifications: in dehydrating grapes to produce rai- (1) Softening point, ring and ball: 126 sins, whereby the residue of the addi- °C minimum as determined by ASTM tive on the raisins does not exceed 200 method E28–67 (Reapproved 1982), parts per million. ‘‘Standard Test Method for Softening [57 FR 12711, Apr. 13, 1992] Point by Ring-and-Ball Apparatus,’’ which is incorporated by reference. § 172.230 Microcapsules for flavoring Copies may be obtained from the Amer- substances. ican Society for Testing Materials, 1916 Microcapsules may be safely used for Race St., Philadelphia, PA 19103, or encapsulating discrete particles of fla- may be examined at the Office of the voring substances that are generally Federal Register, 800 North Capitol recognized as safe for their intended Street, NW., suite 700, Washington, DC use or are regulated under this part, in 20408. accordance with the following condi- (2) Refractive index (n 25/D) 1.63–1.64. tions: (c) It is used or intended for use as a protective coating for grapefruit, lem- (a) The microcapsules may be formu- ons, limes, oranges, tangelos, and tan- lated from the following components, gerines whereby the maximum amount each used in the minimum quantity re- of the resin remaining on the fruit does quired to accomplish the intended ef- not exceed 200 parts per million on a fect: fresh-weight basis. (1) Substances generally recognized (d) To assure safe use of the additive: as safe for the purpose. (1) The label of the market package (2) One or more of the following com- or any intermediate premix of the ad- ponents: ditive shall bear, in addition to the COMPONENT AND LIMITATIONS other information required by the act: (i) The name of the additive, cou- Succinylated gelatin—Not to exceed 15 per- cent by combined weight of the microcap- marone-indene resin. sule and flavoring oil. Succinic acid con- (ii) A statement of the concentration tent of the gelatin is 4.5 to 5.5 percent. of the additive therein. Arabinogalactan—Complying with § 172.610; (2) The label or accompanying label- as adjuvant. ing shall bear adequate directions that, Silicon dioxide—Complying with § 172.480; as if followed, will result in a finished adjuvant. food not in conflict with the require- (3) In lieu of the components listed in ments of this section. paragraph (a)(2) of this section, the fol- [42 FR 14491, Mar. 15, 1977, as amended at 49 lowing components: FR 10103, Mar. 19, 1984] COMPONENT AND LIMITATIONS § 172.225 Methyl and ethyl esters of fatty acids produced from edible Glutaraldehyde—As cross-linking agent for fats and oils. insolubilizing a coacervate of gum arabic and gelatin. Methyl esters and ethyl esters of n-Octyl alcohol—As a defoamer. fatty acids produced from edible fats (4) In lieu of the components listed in and oils may be safely used in food, paragraphs (a)(2) and (3) of this section, subject to the following prescribed con- the following component: ditions: (a) The additive consists of a mixture of either methyl or ethyl esters of COMPONENT AND LIMITATIONS fatty acids produced from edible fats Petroleum wax—Complying with § 172.886. and oils and meets the following speci- Not to exceed 50 percent by combined fications: weight of the microcapsule and spice-fla- (1) Not less than 90 percent methyl or voring substance. ethyl esters of fatty acids. (b) The microcapsules produced from (2) Not more than 1.5 percent unsa- the components listed in paragraphs (a) ponifiable matter. (1), (2), and (3) of this section may be (b) The additive is used or intended used for encapsulating authorized fla- for use at the level not to exceed 3 per- voring oils for use, in accordance with
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good manufacturing practice, in foods Maximum absorb- for which standards of identity estab- ance per lished under section 401 of the Act do Wavelength (milli-microns) centimeter optical not preclude such use, except that pathlength microcapsules formulated from compo- nents listed in paragraph (a)(2) of this 280–289 ...... 0.15 section may be used only for encap- 290–299 ...... 13 300–359 ...... 08 sulating lemon oil, distilled lime oil, 360–400 ...... 02 orange oil, peppermint oil, and spear-
mint oil for use in dry mixes for pud- ANALYTICAL SPECIFICATION FOR PETROLEUM dings and gelatin desserts. NAPHTHA (c) The microcapsules produced from the components listed in paragraphs (a) GENERAL INSTRUCTIONS (1) and (4) of this section may be used All glassware should be scrupulously only for encapsulating authorized cleaned to remove all organic matter such as spice-flavoring substances for use, in oil, grease, detergent residues, etc. Examine accordance with good manufacturing all glassware, including stoppers and stop- practice, in frozen pizzas which are to cocks, under ultraviolet light to detect any be further processed by heat. Such piz- residual fluorescent contamination. As a pre- zas shall bear labels or labeling includ- cautionary measure, it is recommended prac- tice to rinse all glassware with purified iso- ing adequate directions for use to en- octane immediately before use. No grease is sure heating to temperatures which to be used on stopcocks or joints. Great care will melt the wax to release the spice- to avoid contamination of petroleum naph- flavoring substances. tha samples in handling and to assure ab- sence of any extraneous material arising [45 FR 48123, July 18, 1980] from inadequate packaging is essential. Be- cause some of the polynuclear hydrocarbons § 172.235 Morpholine. sought in this test are very susceptible to Morpholine may be safely used as a photo-oxidation, the entire procedure is to component of food, subject to the fol- be carried out under subdued light. lowing restrictions. APPARATUS (a) It is used as the salt(s) of one or more of the fatty acids meeting the re- Separatory funnels. 250-milliliter, and 2,000- quirements of § 172.860, as a component milliliter capacity, equipped with tetra- of protective coatings applied to fresh fluoroethylene polymer stopcocks. Erlenmeyer flask. 125-milliliter with 24/40 fruits and vegetables. standard taper neck. (b) It is used at a level not in excess Evaporation flask. 250-milliliter capacity of that reasonably required to produce all-glass flask equipped with 24/40 standard its intended effect. taper stopper having inlet and outlet tubes to permit passage of nitrogen across the sur- § 172.250 Petroleum naphtha. face of the container liquid to be evaporated. Petroleum naphtha may be safely Condenser. 24/40 joints, fitted with drying used in food in accordance with the fol- tube, length optional. lowing conditions: Spectrophotometric cells. Fused quartz cells, optical path length in the range of 5,000 cen- (a) The additive is a mixture of liquid timeters ±0.005 centimeter; also for checking hydrocarbons, essentially paraffinic spectrophotometer performance only, optical and naphthenic in nature obtained path length in the range 1,000 centimeter from petroleum, ±0.005 centimeter. With distilled water in the (b) The additive is refined to meet cells, determine any absorbance difference. the following specifications when sub- Spectrophotometer. Spectral range 250–400 jected to the procedures described in mµ with spectral slit width of 2 mµ or less; this paragraph. under instrument operating conditions for (1) Boiling-point range: 175 °F–300 °F. these absorbance measurements, the spectro- photometer shall also meet the following (2) Nonvolatile residue: 0.002 gram performance requirements: per 100 milliliters maximum. ± (3) Ultraviolet absorbance limits, as Absorbance repeatability, 0.01 at 0.4 absorb- follows: ance.
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Absorbance accuracy, 1 ±0.05 at 0.4 absorb- Water. All distilled water must be ex- ance. tracted with isooctane before use. A series of Wavelength repeatability, ±0.2 millimicron. three successive extracts of 1.5 liters of dis- Wavelength accuracy, ±1.0 millimicron. tilled water with 100-milliliter portions of isooctane is satisfactory. Ultraviolet lamp. Long wavelength (3400– ° 3800A ). PROCEDURE REAGENTS Determination of ultraviolet absorbance. Add a 25-milliliter aliquot of the hydrocarbon Isooctane (2,2,4-trimethylpentane). Use 180 solvent together with 1 milliliter of hexa- milliliters in a 250-milliliter Erlenmeyer decane to the 125-milliliter Erlenmeyer flask, add 1 milliliter of purified n-hexa- flask. While flushing with nitrogen, evapo- decane, insert the head assembly, allow ni- rate to 1 milliliter on a steam bath. Nitrogen trogen gas to flow into the inlet tube and is admitted through a 8±1-milliliter outer-di- connect the outlet tube to a solvent trap and ameter tube, drawn out into a 2±1-centimeter vacuum line in such a way as to prevent any long and 1±0.5-millimeter inner-diameter back flow of condensate into the flask. The capillary tip. This is positioned so that the contents of the flask are evaporated on a capillary tip extends 4 centimeters into the steam bath until 1 milliliter of residue re- flask. The nitrogen flow rate is such that the mains. Dissolve the 1 milliliter of hexa- surface of the liquid is barely disturbed. decane residue in isooctane and make up to After the volume is reduced to that of the 1 25 milliliters. Determine the absorbance in a milliliter of hexadecane, the flask is left on 5-centimeter path length cell compared to the steam bath for 10 more minutes before isooctane as reference. The absorbance removing. Add 10 milliliters of purified iso- should not exceed 0.01 per centimeter path octane to the flask and reevaporate the solu- length between 280–400 mµ. If necessary, iso- tion to a 1-milliliter volume in the same octane may be purified by passage through a manner as described above, except do not column of activated silica gel (Grade 12, Da- heat for an added 10 minutes. Repeat this op- vidson Chemical Co., Baltimore, Md., or eration twice more. Let the flask cool. equivalent) or by distillation. Methyl alcohol, A.C.S. reagent grade. Use 10 Add 10 milliliters of methyl alcohol and milliliters and proceed as with isooctane. about 0.3 gram of sodium borohydride. (Mini- The absorbance per centimeter of path mize exposure of the borohydride to the at- length should be 0.00 between 280–400 mµ. mosphere; a measuring dipper may be used.) Methyl alcohol may be purified by simple Immediately fit a water-cooled condenser distillation or by refluxing in the presence of equipped with a 24/40 joint and with a drying potassium hydroxide (10 grams/2 liters) and tube into the flask, mix until the sodium zinc dust (25 grams/2 liters) for 3 hours fol- borohydride is dissolved, and allow to stand lowed by distillation. for 30 minutes at room temperature, with n-Hexadecane, 99 percent olefin-free. Dilute intermittent swirling. At the end of this 1.0 milliliter of n-hexadecane to 25 milliliters time, disconnect the flask and evaporate the with isooctane and determine the absorbance methyl alcohol on the steam bath under ni- in a 5-centimeter cell compared to isooctane trogen until sodium borohydride begins to as reference between 280–400 mµ. The absorb- drop out of solution. Remove the flask and ance per centimeter path length shall not ex- let it cool. ceed 0.00 in this range. Purify, if necessary, Add 6 milliliters of isooctane to the flask by percolation through activated silica gel and swirl to wash the crystalline slurry. or by distillation. Carefully transfer the isooctane extract to a Sodium borohydride. 98 percent. 250-milliliter separatory funnel. Dissolve the crystals in the flask with about 25 milliliters of distilled water and pour this also into the 1 As determined by procedure using potas- separatory funnel. Adjust the water volume sium chromate for reference standard and in the separatory funnel to about 100 milli- described in National Bureau of Standards liters and shake for 1 minute. After separa- Circular 484, Spectrophotometry, U.S. De- tion of the layers, draw off the aqueous layer partment of Commerce, (1949). The accuracy into a second 250-milliliter separatory fun- is to be determined by comparison with the nel. Transfer the hydrocarbon layer in the standard values at 290, 345, and 400 milli- first funnel to a 25-milliliter volumetric microns. The procedure is incorporated by flask. reference. Copies of the material incor- Carefully wash the Erlenmeyer flask with porated by reference are available from the an additional 6 milliliters of isooctane, swirl, Center for Food Safety and Applied Nutri- and transfer to the second separatory funnel. tion (HFS–200), Food and Drug Administra- Shake the funnel for 1 minute. After separa- tion, 200 C St. SW., Washington, DC 20204, or tion of the layers, draw off the aqueous layer available for inspection at the Office of the into the first separatory funnel. Transfer the Federal Register, 800 North Capitol Street, isooctane in the second funnel to the volu- NW., suite 700, Washington, DC 20408. metric flask. Again wash the Erlenmeyer
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flask with an additional 6 milliliters of iso- tive coatings on fresh citrus fruit in octane, swirl, and transfer to the first sepa- compliance with § 172.210. ratory funnel. Shake the funnel for 1 minute. After separation of the layers, draw off the [42 FR 14491, Mar. 15, 1977, as amended at 47 aqueous layer and discard. Transfer the iso- FR 11835, Mar. 19, 1982; 49 FR 10104, Mar. 19, octane layer to the volumetric flask and ad- 1984; 54 FR 24896, June 12, 1989] just the volume to 25 milliliters of isooctane. Mix the contents well, then transfer to the § 172.255 Polyacrylamide. first separatory funnel and wash twice with Polyacrylamide containing not more 50-milliliter portions of distilled water. Dis- than 0.2 percent of acrylamide mon- card the aqueous layers after each wash. omer may be safely used as a film Determine the ultraviolet absorbance of former in the imprinting of soft-shell the isooctane extract in 5-centimeter path gelatin capsules when the amount used length cells compared to isooctane as ref- erence between 280–400 mµ. Determine a rea- is not in excess of the minimum re- gent blank concurrently with the sample, quired to produce the intended effect. using 25 milliliters of purified isooctane in- stead of a solvent sample and measuring the § 172.260 Oxidized polyethylene. ultraviolet absorbance of the blank between Oxidized polyethylene may be safely 280–400mµ. used as a component of food, subject to The reagent blank absorbance should not the following restrictions: exceed 0.04 per centimeter path length be- (a) Oxidized polyethylene is the basic µ µ tween 280–289 m ; 0.020 between 290–359 m ; resin produced by the mild air oxida- and 0.010 between 360–400 mµ. tion of polyethylene. The polyethylene Determination of boiling-point range. Use ASTM method D86–82, ‘‘Standard Method for used in the oxidation process conforms Distillation of Petroleum Products,’’ which to the density, maximum n-hexane ex- is incorporated by reference. Copies may be tractable fraction, and maximum xy- obtained from the American Society for lene soluble fraction specifications pre- Testing Materials, 1916 Race St., Philadel- scribed in item 2.3 of the table in phia, PA 19103, or may be examined at the § 177.1520(c) of this chapter. The Office of the Federal Register, 800 North Cap- oxidized polyethylene has a minimum itol Street, NW., suite 700, Washington, DC number average molecular weight of 20408. 1,200, as determined by high tempera- Determination of nonvolatile residue. For hy- ture vapor pressure osmometry; con- drocarbons boiling below 121 °C, determine tains a maximum of 5 percent by the nonvolatile residue by ASTM method weight of total oxygen; and has an acid D1353–78, ‘‘Standard Test Method for Non- value of 9 to 19. volatile Matter in Volatile Solvents for Use in Paint, Varnish, Lacquer, and Related (b) The additive is used or intended Products;’’ for those boiling above 121 °C, use for use as a protective coating or com- ASTM method D381–80, ‘‘Standard Test ponent of protective coatings for fresh Method for Existent Gum in Fuels by Jet avocados, bananas, beets, coconuts, Evaporation,’’ which methods are incor- eggplant, garlic, grapefruit, lemons, porated by reference. Copies may be obtained limes, mango, muskmelons, onions, or- from the American Society for Testing Ma- anges, papaya, peas (in pods), pine- terials, 1916 Race St., Philadelphia, PA 19103, apple, plantain, pumpkin, rutabaga, or may be examined at the Office of the Fed- squash (acorn), sweetpotatoes, tan- eral Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. gerines, turnips, watermelon, Brazil nuts, chestnuts, filberts, hazelnuts, pe- (c) Petroleum naphtha containing cans, and walnuts (all nuts in shells). antioxidants shall meet the specified (c) The additive is used in accordance ultraviolet absorbance limits after cor- with good manufacturing practice and rection for any absorbance due to the in an amount not to exceed that re- antioxidants. Petroleum naphtha may quired to produce the intended effect. contain antioxidants authorized for use in food in an amount not to exceed § 172.270 Sulfated butyl oleate. that reasonably required to accomplish Sulfate butyl oleate may be safely the intended effect or to exceed any used in food, subject to the following prescribed limitations. prescribed conditions: (d) Petroleum naphtha is used or in- (a) The additive is prepared by sul- tended for use as a solvent in protec- fation, using concentrated sulfuric
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acid, of a mixture of butyl esters pro- (d) It is used in an amount not to ex- duced by transesterification of an edi- ceed that required to produce the in- ble vegetable oil using 1-butanol. Fol- tended effect. lowing sulfation, the reaction mixture is washed with water and neutralized § 172.280 Terpene resin. with aqueous sodium or potassium hy- The food additive terpene resin may droxide. Prior to sulfation, the butyl be safely used in accordance with the oleate reaction mixture meets the fol- following prescribed conditions: lowing specifications: (a) The food additive is the beta- (1) Not less than 90 percent butyl ole- pinene polymer obtained by polym- ate. erizing terpene hydrocarbons derived (2) Not more than 1.5 percent unsa- from wood. It has a softening point of ponifiable matter. 112 °C–118 °C, as determined by ASTM (b) The additive is used or intended for use at a level not to exceed 2 per- method E28–67 (Reapproved 1982), cent by weight in an aqueous emulsion ‘‘Standard Test Method for Softening in dehydrating grapes to produce rai- Point By Ring-and-Ball Apparatus,’’ sins, whereby the residue of the addi- which is incorporated by reference. tive on the raisins does not exceed 100 Copies may be obtained from the Amer- parts per million. ican Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or [57 FR 12711, Apr. 13, 1992] may be examined at the Office of the Federal Register, 800 North Capitol § 172.275 Synthetic paraffin and suc- Street, NW., suite 700, Washington, DC cinic derivatives. 20408. Synthetic paraffin and succinic de- (b) It is used or intended for use as rivatives identified in this section may follows: be safely used as a component of food, (1) As a moisture barrier on soft gela- subject to the following restrictions: tin capsules in an amount not to ex- (a) The additive is prepared with 50 ceed 0.07 percent of the weight of the percent Fischer-Tropsch process syn- capsule. thetic paraffin, meeting the definition and specifications of § 172.615, and 50 (2) As a moisture barrier on powders percent of such synthetic paraffin to of ascorbic acid or its salts in an which is bonded succinic anhydride and amount not to exceed 7 percent of the succinic acid derivatives of isopropyl weight of the powder. alcohol, polyethylene glycol, and poly- [42 FR 14491, Mar. 15, 1977, as amended at 49 propylene glycol. It consists of a mix- FR 10104, Mar. 19, 1984] ture of the Fischer-Tropsch process paraffin (alkane), alkyl succinic anhy- Subpart D—Special Dietary and dride, alkyl succinic anhydride iso- Nutritional Additives propyl half ester, dialkyl succinic an- hydride polyethylene glycol half ester, § 172.310 Aluminum nicotinate. and dialkyl succinic anhydride poly- propylene glycol half ester, where the Aluminum nicotinate may be safely alkane (alkyl) has a chain length of 30– used as a source of niacin in foods for 70 carbon atoms and the polyethylene special dietary use. A statement of the and polypropylene glycols have molec- concentration of the additive, ex- ular weights of 600 and 260, respec- pressed as niacin, shall appear on the tively. label of the food additive container or (b) The additive meets the following on that of any intermediate premix specifications: Molecular weight, 880– prepared therefrom. 930; melting point, 215°–217 °F; acid number, 43–47; and saponification num- § 172.315 Nicotinamide-ascorbic acid complex. ber, 75–78. (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
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acid and nicotinamide, melting in the L-Phenylalanine range 141 °C to 145 °C. L-Proline (b) It is used as a source of ascorbic L-Serine acid and nicotinamide in multivitamin L-Threonine preparations. Glutamic Acid Hydrochloride L-Isoleucine § 172.320 Amino acids. L-Lysine Monohydrochloride Monopotassium L-glutamate The food additive amino acids may L-Tyrosine be safely used as nutrients added to L-Valine foods in accordance with the following conditions: (2) As found in ‘‘Specifications and (a) The food additive consists of one Criteria for Biochemical Compounds,’’ or more of the following individual NAS/NRC Publication, 3rd Ed. (1972), amino acids in the free, hydrated or an- which is incorporated by reference hydrous form or as the hydrochloride, (copies are available from the Center sodium or potassium salts: for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra- L-Alanine L-Arginine tion, 200 C St. SW., Washington, DC L-Asparagine 20204, or available for inspection at the L-Aspartic acid Office of the Federal Register, 800 L-Cysteine North Capitol Street, NW., suite 700, L-Cystine Washington, DC 20408) for the fol- L-Glutamic acid lowing: L-Glutamine Aminoacetic acid (glycine) L-Asparagine L-Histidine L-Aspartic acid L-Isoleucine L-Glutamine L-Leucine L-Histidine L-Lysine DL-Methionine (not for infant foods) (c) The additive(s) is used or intended L-Methionine for use to significantly improve the bi- L-Phenylalanine ological quality of the total protein in L-Proline a food containing naturally occurring L-Serine primarily-intact protein that is consid- L-Threonine ered a significant dietary protein L-Tryptophan L-Tyrosine source, provided that: L-Valine (1) A reasonable daily adult intake of the finished food furnishes at least 6.5 (b) The food additive meets the fol- grams of naturally occurring primarily lowing specifications: intact protein (based upon 10 percent of (1) As found in ‘‘Food Chemicals the daily allowance for the ‘‘reference’’ Codex,’’ National Academy of Sciences/ adult male recommended by the Na- National Research Council (NAS/NRC), tional Academy of Sciences in ‘‘Rec- 3d Ed. (1981), which is incorporated by ommended Dietary Allowances,’’ NAS reference (copies may be obtained from Publication No. 1694, 7th Ed. (1968), the National Academy Press, 2101 Con- which is incorporated by reference. stitution Ave. NW., Washington, DC Copies are available from the Center 20418, or may be examined at the Office for Food Safety and Applied Nutrition of the Federal Register, 800 North Cap- (HFS–200), Food and Drug Administra- itol Street, NW., suite 700, Washington, tion, 200 C St. SW., Washington, DC DC 20408) for the following: 20204, or available for inspection at the L-Alanine Office of the Federal Register, 800 L-Arginine North Capitol Street, NW., suite 700, L-Arginine Monohydrochloride Washington, DC 20408. L-Cysteine Monohydrochloride (2) The additive(s) results in a pro- L-Cystine tein efficiency ratio (PER) of protein Aminoacetic acid (glycine) L-Leucine in the finished ready-to-eat food equiv- DL-Methionine alent to casein as determined by the L-Methionine method specified in paragraph (d) of L-Tryptophan this section.
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(3) Each amino acid (or combination ing the additive(s) under the provisions of the minimum number necessary to of this section shall keep and maintain achieve a statistically significant in- throughout the period of his use of the crease) added results in a statistically additive(s) and for a minimum of 3 significant increase in the PER as de- years thereafter, records of the tests termined by the method described in required by this paragraph and other paragraph (d) of this section. The min- records required to assure effectiveness imum amount of the amino acid(s) to and compliance with this regulation achieve the desired effect must be used and shall make such records available and the increase in PER over the pri- upon request at all reasonable hours by marily-intact naturally occurring pro- any officer or employee of the Food tein in the food must be substantiated and Drug Administration, or any other as a statistically significant difference officer or employee acting on behalf of with at least a probability (P) value of the Secretary of Health and Human less than 0.05. Services and shall permit such officer (4) The amount of the additive added or employee to conduct such inven- for nutritive purposes plus the amount tories of raw and finished materials on naturally present in free and combined hand as he deems necessary and other- (as protein) form does not exceed the wise to check the correctness of such following levels of amino acids ex- records. pressed as percent by weight of the (e) To assure safe use of the additive, total protein of the finished food: the label and labeling of the additive and any premix thereof shall bear, in Percent by weight of addition to the other information re- total pro- quired by the Act, the following: tein (ex- pressed as (1) The name of the amino acid(s) free amino contained therein including the spe- acid) cific optical and chemical form. L-Alanine ...... 6.1 (2) The amounts of each amino acid L-Arginine ...... 6.6 contained in any mixture. L-Aspartic acid (including L-asparagine) ...... 7.0 (3) Adequate directions for use to L-Cystine (including L-cysteine) ...... 2.3 L-Glutamic acid (including L-glutamine) ...... 12.4 provide a finished food meeting the Aminoacetic acid (glycine) ...... 3.5 limitations prescribed by paragraph (c) L-Histidine ...... 2.4 of this section. L-Isoleucine ...... 6.6 L-Leucine ...... 8.8 (f) The food additive amino acids L-Lysine ...... 6.4 added as nutrients to special dietary L- and DL-Methionine ...... 3.1 foods that are intended for use solely L-Phenylalanine ...... 5.8 L-Proline ...... 4.2 under medical supervision to meet nu- L-Serine ...... 8.4 tritional requirements in specific med- L-Threonine ...... 5.0 ical conditions and comply with the re- L-Tryptophan ...... 1.6 quirements of part 105 of this chapter L-Tyrosine ...... 4.3 L-Valine ...... 7.4 are exempt from the limitations in paragraphs (c) and (d) of this section (d) Compliance with the limitations and may be used in such foods at levels concerning PER under paragraph (c) of not to exceed good manufacturing this section shall be determined by the practices. method described in sections 43.212– [42 FR 14491, Mar. 15, 1977; 42 FR 56728, Oct. 43.216, ‘‘Official Methods of Analysis of 28, 1977, as amended at 47 FR 11836, Mar. 19, the Association of Official Analytical 1982; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, Chemists,’’ 13th Ed. (1980), which is in- June 12, 1989; 59 FR 14550, Mar. 29, 1994; 61 FR corporated by reference. Copies may be 14480, Apr. 2, 1996] obtained from the Association of Offi- cial Analytical Chemists International, § 172.325 Bakers yeast protein. 481 North Frederick Ave., suite 500, Bakers yeast protein may be safely Gaithersburg, MD 20877–2504, or may be used in food in accordance with the fol- examined at the Office of the Federal lowing conditions: Register, 800 North Capitol Street, (a) Bakers yeast protein is the insol- NW., suite 700, Washington, DC 20408. uble proteinaceous material remaining Each manufacturer or person employ- after the mechanical rupture of yeast
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cells of Saccharomyces cerevisiae and re- excess of that reasonably required to moval of whole cell walls by cen- produce its intended effect. trifugation and separation of soluble cellular materials. § 172.340 Fish protein isolate. (b) The additive meets the following (a) The food additive fish protein iso- specifications on a dry weight basis: late may be safely used as a food sup- (1) Zinc salts less than 500 parts per plement in accordance with the fol- million (ppm) as zinc. lowing prescribed conditions: (2) Nucleic acid less than 2 percent. (1) The additive shall consist prin- (3) Less than 0.3 ppm arsenic, 0.1 ppm cipally of dried fish protein prepared cadmium, 0.4 ppm lead, 0.05 ppm mer- from the edible portions of fish after cury, and 0.3 ppm selenium. removal of the heads, fins, tails, bones, (c) The viable microbial content of scales, viscera, and intestinal contents. the finished ingredient is: (2) The additive shall be derived only (1) Less than 10,000 organisms/gram from species of bony fish that are gen- by aerobic plate count. erally recognized by qualified sci- (2) Less than 10 yeasts and molds/ entists as safe for human consumption gram. and that can be processed as prescribed (3) Negative for Salmonella, E. coli, to meet the required specifications. coagulase positive Staphylococci, Clos- (3) Only wholesome fresh fish other- tridium perfringens, Clostridium botu- wise suitable for human consumption linum, or any other recognized micro- may be used. The fish shall be handled bial pathogen or any harmful microbial expeditiously under sanitary condi- toxin. tions. These conditions shall be in ac- (d) The ingredient is used in food as cordance with recognized good manu- a nutrient supplement as defined in facturing practice for fish to be used as § 170.3(o)(20) of this chapter. human food. (4) The additive shall be prepared by § 172.330 Calcium pantothenate, cal- extraction with hexane and food-grade cium chloride double salt. ethanol to remove fat and moisture. The food additive calcium chloride Solvent residues shall be reduced by double salt of calcium pantothenate drying. may be safely used in foods for special (b) The food additive meets the fol- dietary uses in accordance with good lowing specifications: (Where methods manufacturing practice and under the of determination are specified, they are following prescribed conditions: Association of Official Analytical (a) The food additive is of the d (dex- Chemists Methods, 13th ed., 1980, which trorotatory) or the dl (racemic) form. are incorporated by reference). 1 (b) To assure safe use of the additive, (1) Protein content, as N × 6.25, shall the label and labeling of the food addi- not be less than 90 percent by weight of tive container, or that of any inter- the final product, as determined by the mediate premixes prepared therefrom, method described in section 2.057, Im- shall bear, in addition to the other in- proved Kjeldahl Method for Nitrate- formation required by the Act, the fol- Free Samples (20)—Official Final Ac- lowing: tion. (1) The name of the additive ‘‘cal- (2) Moisture content shall not be cium chloride double salt of d-calcium more than 10 percent by weight of the pantothenate’’ or ‘‘calcium chloride final product, as determined by the double salt of dl-calcium panto- method described in section 24.003, Air thenate’’, whichever is appropriate. Drying (1)—Official First Action. (2) A statement of the appropriate (3) Fat content shall not be more concentration of the additive, ex- than 0.5 percent by weight of the final pressed as pantothenic acid. 1 Copies are available from: Association of § 172.335 D-Pantothenamide. Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithers- The food additive D-pantothenamide burg, MD 20877–2504, or examined at the Of- as a source of pantothenic acid activ- fice of the Federal Register, 800 North Cap- ity, may be safely used in foods for spe- itol Street, NW., suite 700, Washington, DC cial dietary use in an amount not in 20408.
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product, as determined by the method (f) Folic acid may be added to a med- described in section 24.005, Crude Fat ical food, as defined in section 5(b)(3) of or Ether Extract—Official Final Ac- the Orphan Drug Act (21 U.S.C. tion. 360ee(b)(3)), at levels not to exceed the (4) Solvent residues in the final prod- amount necessary to meet the distinc- uct shall not be more than 5 parts per tive nutritional requirements of the million of hexane and 3.5 percent eth- disease or condition for which the food anol by weight. is formulated. [46 FR 38072, July 24, 1981, as amended at 47 (g) Folic acid may be added to food FR 53344, Nov. 26, 1982; 54 FR 24897, June 12, for special dietary use at levels not to 1989] exceed the amount necessary to meet the special dietary needs for which the § 172.345 Folic acid (folacin). food is formulated. Folic acid (CAS Reg. No. 59–30–3), (h) Folic acid may be added to foods also known as folacin or folate, may be represented as meal-replacement prod- safely used in food as a nutrient in ac- ucts, in amounts not to exceed: cordance with the following prescribed (1) Four hundred µg per serving if the conditions: food is a meal-replacement that is rep- (a) Folic acid is the chemical N-[4- resented for use once per day; or [[(2-amino-1,4-dihydro-4-oxo-6-pteri- (2) Two hundred µg per serving if the dinyl)methyl]amino]benzoyl]-L-glu- food is a meal-replacement that is rep- tamic acid. resented for use more than once per (b) Folic acid meets the specifica- day. tions of the ‘‘Food Chemicals Codex,’’ [61 FR 8807, Mar. 5, 1996, as amended at 61 FR 4th ed. (1996), pp. 157–158, which is in- 27779, June 3, 1996; 64 FR 1758, Jan. 12, 1999] corporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. § 172.350 Fumaric acid and salts of fu- Copies are available from the National maric acid. Academy Press, Box 285, 2101 Constitu- Fumaric acid and its calcium, fer- tion Ave. NW., Washington, DC 20055 rous, magnesium, potassium, and so- (Internet address ‘‘http:// dium salts may be safely used in food www.nap.edu’’), or may be examined at in accordance with the following pre- the Center for Food Safety and Applied scribed conditions: Nutrition’s Library, Food and Drug Ad- ministration, 200 C St. SW., rm. 3321, (a) The additives meet the following Washington, DC, or at the Office of the specifications: Federal Register, 800 North Capitol St. (1) Fumaric acid contains a minimum NW., suite 700, Washington, DC. of 99.5 percent by weight of fumaric (c) Folic acid may be added to foods acid, calculated on the anhydrous subject to a standard of identity estab- basis. lished under section 401 of the Federal (2) The calcium, magnesium, potas- Food, Drug, and Cosmetic Act (the act) sium, and sodium salts contain a min- when the standard of identity specifi- imum of 99 percent by weight of the re- cally provides for the addition of folic spective salt, calculated on the anhy- acid. drous basis. Ferrous fumarate contains (d) Folic acid may be added, at levels a minimum of 31.3 percent total iron not to exceed 400 micrograms (µg) per and not more than 2 percent ferric serving, to breakfast cereals, as defined iron. under § 170.3(n)(4) of this chapter, and (b) With the exception of ferrous fu- to corn grits at a level such that each marate, fumaric acid and the named pound of corn grits contains not more salts are used singly or in combination than 1.0 milligram of folic acid. in food at a level not in excess of the (e) Folic acid may be added to infant amount reasonably required to accom- formula in accordance with section plish the intended effect. 412(i)(1) of the act or with regulations (c) Ferrous fumarate is used as a issued under section 412(i)(2) of the act source of iron in foods for special die- which are codified in § 107.100 of this tary use, when the use is consistent chapter. with good nutrition practice.
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§ 172.365 Kelp. tate; 50 ppm ethyl alcohol; 10 ppm Kelp may be safely added to a food as methyl alcohol; and 10 ppm acetone, a source of the essential mineral io- when used as processing solvents. dine, provided the maximum intake of (c) The additive is used or intended the food as may be consumed during a for use as a source of L-methionine to period of one day, or as directed for use improve significantly the biological in the case of a dietary supplement, quality of the total protein in a food will not result in daily ingestion of the containing naturally occurring pri- additive so as to provide a total marily intact vegetable protein that is amount of iodine in excess of 225 considered a significant dietary protein micrograms for foods labeled without source, provided that: reference to age or physiological state; (1) A reasonable daily adult intake of and when age or the conditions of preg- the finished food furnishes at least 6.5 nancy or lactation are specified, in ex- grams of naturally occurring primarily cess of 45 micrograms for infants, 105 intact vegetable protein. micrograms for children under 4 years (2) The additive results in a protein of age, 225 micrograms for adults and efficiency ratio (PER) of protein in the children 4 or more years of age, and 300 finished ready-to-eat food equivalent micrograms for pregnant or lactating to casein as determined by the method women. The food additive kelp is the specified in paragraph (d) of this sec- dehydrated, ground product prepared tion. from Macrocystis pyrifera, Laminaria (3) The use of the additive results in digitata, Laminaria saccharina, and Lam- a statistically significant increase in inaria cloustoni. the PER as determined by the method described in paragraph (d) of this sec- § 172.370 Iron-choline citrate complex. tion. The minimum amount of the ad- Iron-choline citrate complex made by ditive to achieve the desired effect reacting approximately equimolecular must be used, and the increase in PER quantities of ferric hydroxide, choline, over the primarily intact naturally oc- and citric acid may be safely used as a curring vegetable protein in the food source of iron in foods for special die- must be substantiated as a statis- tary use. tically significant difference with at least a probability (P) value of less § 172.372 N-Acetyl-L-methionine. than 0.05. The food additive N-acetyl-L-methio- (4) The amount of the additive added nine may be safely added to food (ex- for nutritive purpose shall not exceed cept infant foods and foods containing the level that will provide a total of 3.1 added nitrites/nitrates) as a source of percent L- and DL-methionine (ex- L-methionine for use as a nutrient in pressed as the free amino acid) by accordance with the following condi- weight of the total protein of the fin- tions: ished food, including the amount natu- (a) N-Acetyl-L-methionine (Chemical rally present in free and combined (as Abstracts Service Registry No. 65–82–7) protein) form. is the derivative of the amino acid me- (5) The additive shall not be added to thionine formed by addition of an infant foods or to foods containing acetyl group to the alpha-amino group added nitrites/nitrates. of methionine. It may be in the free, (d) Compliance with the limitations hydrated or anhydrous form, or as the concerning PER under paragraph (c) of sodium or potassium salts. the section shall be determined by the (b) The additive meets the following method described in sections 43.212– specifications: 43.216, ‘‘Official Methods of Analysis of (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
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Register, 800 North Capitol Street, or as directed for use in the case of a NW., suite 700, Washington, DC 20408. dietary supplement, will not result in Each manufacturer or person employ- daily ingestion of the additive so as to ing the additive under the provisions of provide a total amount of iodine in ex- this section shall keep and maintain cess of 225 micrograms for foods labeled throughout the period of use of the ad- without reference to age or physio- ditive and for a minimum of 3 years logical state; and when age or the con- thereafter, records of the tests required ditions of pregnancy or lactation are by this paragraph and other records re- specified, in excess of 45 micrograms quired to assure effectiveness and com- for infants, 105 micrograms for children pliance with this regulation. Those under 4 years of age, 225 micrograms records shall be made available upon for adults and children 4 or more years request at all reasonable hours by any of age, and 300 micrograms for preg- officer or employee acting on behalf of nant or lactating women. the Secretary of Health and Human (b) To assure safe use of the additive, Services. Those officers or employees in addition to the other information re- shall be permitted to conduct inven- quired by the Act, the label of the addi- tories of raw and finished materials on tive shall bear: hand as are deemed necessary to verify (1) The name of the additive. the records. (2) A statement of the concentration (e) To assure safe use of the additive, of the additive in any mixture. the label and labeling of the additive and any premix thereof shall bear, in § 172.385 Whole fish protein con- addition to the other information re- centrate. quired by the Act, the following: The food additive whole fish protein (1) The name of the additive con- concentrate may be safely used as a tained therein. food supplement in accordance with (2) The amounts of additive and each the following prescribed conditions: amino acid contained in any mixture. (a) The additive is derived from (3) Adequate directions for use to whole, wholesome hake and hakelike provide a finished food meeting the fish, herring of the genera Clupea, men- limitations prescribed by paragraph (c) haden, and anchovy of the species En- of this section. graulis mordax, handled expeditiously (f) When the food additive is added as and under sanitary conditions in ac- a nutrient to special dietary foods that cordance with good manufacturing are intended for use solely under med- practices recognized as proper for fish ical supervision to meet nutritional re- that are used in other forms for human quirements in specific medical condi- food. tions and these foods comply with the (b) The additive consists essentially requirements of part 105 of this chap- of a dried fish protein processed from ter, the food additive is exempt from the whole fish without removal of the limitations in paragraphs (c)(1) heads, fins, tails, viscera, or intestinal through (4) and (d) of this section and contents. It is prepared by solvent ex- may be used in those foods at levels traction of fat and moisture with iso- not to exceed good manufacturing propyl alcohol or with ethylene dichlo- practices. ride followed by isopropyl alcohol, ex- [43 FR 27784, June 27, 1978, as amended at 46 cept that the additive derived from FR 59968, Dec. 8, 1981; 49 FR 10104, Mar. 19, herring, menhaden and anchovy is pre- 1984; 54 FR 24897, June 12, 1989] pared by solvent extraction with iso- propyl alcohol alone. Solvent residues § 172.375 Potassium iodide. are reduced by conventional heat dry- The food additive potassium iodide ing and/or microwave radiation and may be safely used in accordance with there is a partial removal of bone. the following prescribed conditions: (c) The food additive meets the fol- (a) Potassium iodide may be safely lowing specifications: added to a food as a source of the es- (1) Protein content (N × 6.25) shall sential mineral iodine, provided the not be less than 75 percent by weight of maximum intake of the food as may be the final product, as determined by the consumed during a period of one day, method described in section 2.057 in
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‘‘Official Methods of Analysis of the (e) When the additive is used as a Association of Official Analytical protein supplement in manufactured Chemists’’ (AOAC), 13th Ed. (1980). Pro- food, the total fluoride content (ex- tein quality shall not be less than 100, pressed as F) of the finished food shall as determined by the method described not exceed 8 ppm based on the dry in sections 43.212–43.216 of the AOAC. weight of the food product. The 13th Ed. is incorporated by ref- (f) To assure safe use of the additive, erence, and copies may be obtained in addition to the other information re- from the Association of Official Ana- quired by the Act: lytical Chemists International, 481 (1) The label of consumer-sized or North Frederick Ave., suite 500, Gai- bulk containers of the additive shall thersburg, MD 20877–2504, or may be ex- bear the name ‘‘whole fish protein con- amined at the Office of the Federal centrate’’. Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (2) The label or labeling of containers of the additive shall bear adequate di- (2) Moisture content shall not exceed rections for use to comply with the 10 percent by weight of the final prod- uct, as determined by the method de- limitations prescribed by paragraphs scribed in section 24.003 of the AOAC. (d) and (e) of this section. See paragraph (c)(1) of this section for (3) Labels of manufactured foods con- availability of the material incor- taining the additive shall bear, in the porated by reference. ingredient statement, the name of the (3) Fat content shall not exceed 0.5 additive, ‘‘whole fish protein con- percent by weight of the final product, centrate’’ in the proper order of de- as determined by the method described creasing predominance in the finished in section 24.005 of the AOAC. See para- food. graph (c)(1) of the this section for [42 FR 14491, Mar. 15, 1977, as amended at 49 availability of the material incor- FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, porated by reference. 1989] (4) The additive may contain residues of isopropyl alcohol and ethylene di- § 172.395 Xylitol. chloride not in excess of 250 parts per Xylitol may be safely used in foods million and 5 parts per million, respec- for special dietary uses, provided the tively, when used as solvents in the ex- amount used is not greater than that traction process. required to produce its intended effect. (5) Microwave radiation meeting the requirements of § 179.30 of this chapter § 172.399 Zinc methionine sulfate. may be used to reduce residues of the solvents used in the extraction process. Zinc methionine sulfate, CAS Reg. (6) The additive shall contain not in No. 56329–42–1, may be safely used in excess of 100 parts per million fluorides accordance with the following pre- (expressed as F). scribed conditions: (7) The additive shall be free of Esch- (a) The additive is the product of the erichia coli and pathogenic organisms, reaction between equimolar amounts of including Salmonella, and shall have a zinc sulfate and DL-methionine in puri- total bacterial plate count of not more fied water. than 10,000 per gram. (b) The additive meets the following (8) The additive shall have no more specifications: than a faint characteristic fish odor Zinc content—19 to 22 percent. and taste. C5H11NO2S ‘‘DL-methionine’’—46 to 50 per- (d) When the additive is used or in- cent. tended for use in the household as a Cadmium—not more than 0.05 part per mil- protein supplement in food for regular lion. consumption by children up to 8 years of age, the amount of the additive from (c) The additive is used in tablet form this source shall not exceed 20 grams as a source of dietary zinc. per day (about one heaping table- [46 FR 58297, Dec. 1, 1981] spoon).
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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 decahy- drate; 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 dis- tillate form only; in alco- holic 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; fin- ished 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 ref- erence. 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. Acetophenone; methyl phenyl ketone. (a) They are used in the minimum Allyl anthranilate. quantity required to produce their in- Allyl butyrate. tended effect, and otherwise in accord- Allyl cinnamate. ance with all the principles of good Allyl cyclohexaneacetate. manufacturing practice. Allyl cyclohexanebutyrate. Allyl cyclohexanehexanoate. (b) They consist of one or more of the Allyl cyclohexaneproprionate. following, used alone or in combination Allyl cyclohexanevalerate. with flavoring substances and adju- Allyl disulfide. vants generally recognized as safe in Allyl 2-ethylbutyrate.
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Allyl hexanoate; allyl caproate. Benzyl salicylate. Allyl α-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. β-Bourbonene; 1,2,3,3a,3bβ,4,5,6,6aβ,6bα-deca- Allyl phenoxyacetate. hydro-lα-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 α-Amylcinnamaldehyde. ester, butyrate. α-Amylcinnamaldehyde dimethyl acetal. α-Butylcinnamaldehyde. α-Amylcinnamyl acetate. Butyl cinnamate. α-Amylcinnamyl alcohol. Butyl 2-decenoate. α-Amylcinnamyl formate. Butyl ethyl malonate. α-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. β-Caryophyllene. Benzyl disulfide; dibenzyl disulfide. Caryophyllene alcohol. Benzyl ethyl ether. Caryophyllene alcohol acetate. Benzyl formate. β-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; α-toluenethiol. 1,4-Cineole. Benzyl methoxyethyl acetal; acetaldehyde Cinnamaldehyde ethylene glycol acetal. benzyl β-methoxyethyl acetal. Cinnamic acid. Benzyl phenylacetate. Cinnamyl acetate. Benzyl propionate. Cinnamyl alcohol; 3-phenyl-2-propen-1-ol.
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Cinnamyl benzoate. α,α-Dimethylbenzyl isobutyrate; phenyldi- Cinnamyl butyrate. methylcarbinyl isobutyrate. Cinnamyl cinnamate. 2,6-Dimethyl-5-heptenal. Cinnamyl formate. 2,6-Dimethyl octanal; isodecylaldehyde. Cinnamyl isobutyrate. 3,7-Dimethyl-1-octanol; tetrahydrogeraniol. Cinnamyl isovalerate. α,α-Dimethylphenethyl acetate; benzyl- Cinnamyl phenylacetate. propyl acetate; benzyldimethylcarbinyl ac- Cinnamyl propionate. etate. Citral diethyl acetal; 3,7-dimethyl-2,6-octa- α,α-Dimethylphenethyl alcohol; dimethyl- dienal diethyl acetal. benzyl carbinol. Citral dimethyl acetal; 3,7-dimethyl-2,6-octa- α,α-Dimethylphenethyl butyrate; benzyl- dienal dimethyl acetal. dimethylcarbinyl butyrate. Citral propylene glycol acetal. α,α-Dimethylphenethyl formate; benzyldi- Citronellal; 3,7-dimethyl-6-octenal; rhodinal. methylcarbinyl formate. Citronellol; 3,7-dimethyl-6-octen-1-ol; d-cit- Dimethyl succinate. ronellol. 1,3-Diphenyl-2-propanone; dibenzyl ketone. Citronelloxyacetaldehyde. delta-Dodecalactone; 5-hydroxydodecanoic Citronellyl acetate. acid, deltalactone. γ γ Citronellyl butyrate. -Dodecalactone; 4-hydroxydodecanoic acid - Citronellyl formate. lactone. Citronellyl isobutyrate. 2-Dodecenal. Citronellyl phenylacetate. Estragole. ρ Citronellyl propionate. -Ethoxybenzaldehyde. Citronellyl valerate. Ethyl acetoacetate. 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 ρ-anisate. Cyclohexaneethyl acetate. Ethyl anthranilate. Cyclohexyl acetate. Ethyl benzoate. Cyclohexyl anthranilate. Ethyl benzoylacetate. Cyclohexyl butyrate. α-Ethylbenzyl butyrate; α-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. γ-Decalactone; 4-hydroxy-decanoic acid, γ- 2-Ethylbutyraldehyde. lactone. 2-Ethylbutyric acid. γ-Decalactone; 5-hydroxy-decanoic acid, δ- 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-γ-butyrolactone; 4,4-dibutyl-4-hy- Ethyl hexanoate. droxy-butyric acid, γ-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. ω-6-Hexadecenlactone; 16-hydroxy-6- Ethyl 3-phenylpropionate; ethyl hydro- hexadecenoic acid, ω-lactone; cinnamate. ambrettolide. Ethyl propionate. γ-Hexalactone; 4-hydroxyhexanoic acid, γ-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- α-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. α-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1- Guaiacyl acetate; µ -methoxyphenyl acetate. yl)-3-buten-2-one. Guaiacyl phenylacetate. β-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1- Guaiene; 1,4-dimethyl-7-isopropenyl-∆9,10- yl)-3-buten-2-one. octahydroazulene. α-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene- Guaiol acetate; 1,4-dimethyl-7-(α-hydroxy- 1-yl)-3-buten-2-one; 6-methylionone. isopropyl)-δ9,10-octahydroazulene acetate. Isoamyl acetate. γ-Heptalactone; 4-hydroxyheptanoic acid, γ- 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; α-isoamyl furfuryl- 3-Heptanone; ethyl butyl ketone. propionate. 4-Heptanone; dipropyl ketone. Isoamyl 2-furanpropionate; α-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. α-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- α-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 γ-ionone. one; methoxystyryl isopropyl ketone. Isopropyl acetate. 1-(p-Methoxyphenyl)-1-penten-3-one; α- ρ-Isopropylacetophenone. methylanisylidene acetone; ethone. Isopropyl alcohol; isopropanol. 1-(p-Methoxyphenyl)-2-propanone; Isopropyl benzoate. anisylmethyl ketone; anisic ketone. ρ-Isopropylbenzyl alcohol; cuminic alcohol; 2-Methoxy-4-vinylphenol; p-vinylguaiacol. ρ-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. ρ-Isopropylphenylacetaldehyde; ρ-cymen-7- p-Methylanisole; p-cresyl methyl ether; p- carboxaldehyde. methoxytoluene. Isopropyl phenylacetate. Methyl benzoate. 3-(ρ-Isopropylphenyl)-propionaldehyde; ρ-iso- Methylbenzyl acetate, mixed o-,m-,p-. propylhydrocinnamaldehyde; cuminyl ac- α-Methylbenzyl acetate; styralyl acetate. etaldehyde. α-Methylbenzyl alcohol; styralyl alcohol. Isopropyl propionate. α-Methylbenzyl butyrate; styralyl butyrate. Isopulegol; p-menth-8-en-3-ol. α-Methylbenzyl isobutyrate; styralyl iso- Isopulegone; p-menth-8-en-3-one. butyrate. Isopulegyl acetate. α-Methylbenzyl formate; styralyl formate.
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α-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; α-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- α-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 α-ionone; 5-(2,6,6-trimethyl-2-cyclo- 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 β-ionone; 5-(2,6,6-trimethyl-1-cyclo- 3-ol. hexen-1-yl)-4-penten-3-one. Neryl acetate. ∆ Methyl -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. α hyde; -methyl-p-isopropylhydro- Neryl propionate. cinnamal- dehyde; cyclamen aldehyde. 2,6-Nonadien-1-ol. Methyl isovalerate. γ-Nonalactone; 4-hydroxynonanoic acid, γ- 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 β-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-β-ocimene; 3,7-dimethyl-1,3,6- bonate. octatriene. 2-Methyloctanal; methyl hexyl acetaldehyde. γ-Octalactone; 4-hydroxyoctanoic acid, γ-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. β-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. α-Pinene; 2-pinene. Octyl phenylacetate. β-Pinene; 2(10)-pinene. Octyl propionate. Pine tar oil. ω-Pentadecalactone; 15-hydroxypentadeca- Pinocarveol; 2(10)-pinen-3-ol. noic acid, ω-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 α-Phellandrene; ρ-mentha-1,5-diene. monolaurate. Phenethyl acetate. Polysorbate 60; polyoxyethylene (20) sorbitan Phenethyl alcohol; β-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; α-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; α-toluic acid. α-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, α and β. 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. α-Terpinene. may be used as an antioxidant in fla- γ-Terpinene. voring substances whereby the additive α-Terpineol; p-menth-1-en-8-ol. does not exceed 0.5 percent of the es- β-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 γ-Undecalactone; 4-hydroxyundecanoic acid may be safely used in food in accord- γ-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) ∆-Decalactone and ∆- 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 ex- tract 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 non- volatile 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 hydro- gen 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 absorp- tivity 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 drop-softening point of 109 °C–119 °C, and a color of M or paler. Glycerol ester of partially hydrogenated gum or Having an acid number of 3–10, a drop-softening point of 79 °C–88 °C, and wood rosin. a color of N or paler. Glycerol ester of polymerized rosin ...... Having an acid number of 3–12, a melting-point range 80 °C–126 °C, and a color of M or paler. Glycerol ester of gum rosin ...... Having an acid number of 5–9, a drop-softening point of 88 °C–96 °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 drop-softening point of 102 °C–110 °C, gum or wood resin. and a color of K or paler. Pentaerythritol ester of gum or wood rosin ...... Having an acid number of 6–16, a drop-softening point of 109 °C–116 °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 αpinene, βpinene, 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 α-pinene; softening point minimum 155 °C, deter- mined 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 com- bination. 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] (c) To assure safe use of the additive, in addition to the other information re- § 172.620 Carrageenan. quired by the act, the label and label- The food additive carrageenan may ing of the food additive shall bear the be safely used in food in accordance name of the additive, ‘‘chewing gum with the following prescribed condi- base.’’ As used in this paragraph, the 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., ‘‘so- specifications and requirements of dium carrageenan’’, ‘‘potassium carra- § 172.840 (a) and (b) in accordance with geenan’’, 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 The food additive gellan gum may be be examined at the Center for Food safely used in food in accordance with Safety and Applied Nutrition’s Li- the following prescribed conditions: brary, Food and Drug Administration, (a) The additive is a high molecular 200 C St. SW., rm. 3321, Washington, weight polysaccharide gum produced DC, or at the Office of the Federal Reg- from Pseudomonas elodea by a pure cul- ister, 800 North Capitol St. NW., suite ture fermentation process and purified 700, 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 lo- cust 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, potas- sium, 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 ‘‘posi- tion, 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- α-[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 α-[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 copoly- mer 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 fol- lowing 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 sor- ghum. 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, 200 C St. SW., Washington, DC 20204–0001, or may bean oil fatty acids (C16-C18) as a surfactant in emulsifier blends that are added to the be examined at the Center for Food herbicide atrazine for application to corn. Safety and Applied Nutrition’s Li- Diethanolamide condensate based on brary, Food and Drug Administration, stripped coconut fatty acids (C10 C18) as a 200 C St. SW., rm. 3321, Washington, surfactant in emulsifier blends that are DC, or at the Office of the Federal Reg- added to the herbicide atrazine for applica- ister, 800 North Capitol St. NW., suite tion to corn. α-(p-Dodecylphenyl)-omega-hydroxypoly 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 ex- salt of lactobionic acid (4-(β,D- amined at the Center for Food Safety galactosido)-D-gluconic acid) produced and Applied Nutrition’s Library, Food by the oxidation of lactose. and Drug Administration, 200 C St. (b) It is used or intended for use as a SW., rm. 3321, Washington, DC, or at firming agent in dry pudding mixes at the Office of the Federal Register, 800 a level not greater than that required North Capitol St. NW., suite 700, Wash- to accomplish the intended effect. ington, 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 react- ing 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 per- cent, 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- pressed as gibberellic acid, and the sulting from the use of the treated treated malt is to be used in the pro- malt plus additional residues of inor- duction of fermented malt beverages or ganic bromides that may be present 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 the package. (1) The name of the additive. (3) Adequate use directions to provide (2) Adequate directions for use. not more than 2 parts per million of (c) To assure safe use of the additive, 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 filled in with the words ‘‘gibberellic Glycerol ester of wood rosin may be acid’’ or ‘‘potassium gibberellate’’, safely used in food in accordance with whichever is appropriate; and the following prescribed conditions: (2) ‘‘Brewer’s malt—To be used in the (a) It has an acid number of 3 to 9, a production of fermented malt bev- drop-softening point of 88 °C–96 °C; and erages only’’ or ‘‘Distiller’s malt—To a color of N or paler as determined in 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 rections for use to insure compliance fatty acids conforming with § 172.860. with paragraph (b) of this section. Stearyl alcohol...... Derived from fatty acids con- forming 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 divinylbenzene. The divinylbenzene Acid number 40 to 52. functions as a cross-linking agent and Total citric acid 15 to 18 percent. constitutes a minimum of 4 percent of Saponification number 215–255. 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 B12 in foods for special dietary § 172.765 Succistearin (stearoyl pro- use. pylene glycol hydrogen succinate). The food additive succistearin (ste- Subpart I—Multipurpose Additives aroyl propylene glycol hydrogen succi- nate) may be safely used in food in ac- § 172.800 Acesulfame potassium. cordance with the following prescribed Acesulfame potassium (CAS Reg. No. conditions: 55589–62–3), also known as acesulfame (a) The additive is the reaction prod- K, may be safely used as a sweetening uct of succinic anhydride, fully hydro- agent in food in accordance with the genated vegetable oil (predominantly following prescribed conditions: C16 or C18 fatty acid chain length), and (a) Acesulfame potassium is the po- propylene glycol. tassium salt of 6-methyl-1,2,3- (b) The additive meets the following oxathiazine-4(3H)-one-2,2-dioxide. specifications: (b) The additive meets the following specifications: Acid number 50–150. (1) Purity is not less than 99 percent Hydroxyl number 15–50. on a dry basis. The purity shall be de- Succinated ester content 45–75 percent. termined by a method titled (c) The additive is used or intended ‘‘Acesulfame Potassium Assay,’’ which for use as an emulsifier in or with is incorporated by reference. Copies are shortenings and edible oils intended for available from the Center for Food use in cakes, cake mixes, fillings, Safety and Applied Nutrition (HFS– icings, pastries, and toppings, in ac- 200), Food and Drug Administration, cordance with good manufacturing 200 C St. SW., Washington, DC 20204, or practice. available for inspection at the Office of
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the FEDERAL REGISTER, 800 North Cap- § 172.802 Acetone peroxides. itol Street, NW., suite 700, Washington, The food additive acetone peroxides DC 20408. may be safely used in flour, and in (2) Fluoride content is not more than bread and rolls where standards of 30 parts per million, as determined by identity do not preclude its use, in ac- method III of the Fluoride Limit Test cordance with the following prescribed of the Food Chemicals Codex, 3d Ed. conditions: (1981), p. 511, which is incorporated by (a) The additive is a mixture of reference. Copies are available from monomeric and linear dimeric acetone the National Academy Press, 2101 Con- peroxide, with minor proportions of stitution Ave. NW., Washington, DC higher polymers, manufactured by re- 20418, or available for inspection at the action of hydrogen peroxide and ace- Office of the Federal Register, 800 tone. North Capitol Street, NW., suite 700, (b) The additive may be mixed with Washington, DC 20408. an edible carrier to give a concentra- (c) The additive may be used in the tion of: (1) 3 grams to 10 grams of hy- drogen peroxide equivalent per 100 following foods when standards of iden- grams of the additive, plus carrier, for tity established under section 401 of use in flour maturing and bleaching; or the Federal Food, Drug, and Cosmetic (2) approximately 0.75 gram of hydro- Act do not preclude such use: gen peroxide equivalent per 100 grams (1) Sugar substitute, including granu- of the additive, plus carrier, for use in lated, powdered, liquid, and tablet dough conditioning. form. (c) It is used or intended for use: (1) (2) [Reserved] In maturing and bleaching of flour in a (3) Chewing gum. quantity not more than sufficient for (4) Dry bases for beverages, instant such effect; and (2) as a dough-condi- coffee, and instant tea. tioning agent in bread and roll produc- (5) Dry bases for gelatins, puddings, tion at not to exceed the quantity of and pudding desserts. hydrogen peroxide equivalent nec- (6) Dry bases for dairy product essary for the artificial maturing ef- fect. analogs. (d) To insure safe use of the additive, (7) Confections, hard candy, and soft the label of the food additive container candy. and any intermediate premix thereof (8) Baked goods and baking mixes, in- shall bear, in addition to the other in- cluding frostings, icings, toppings, and formation required by the act: fillings for baked goods. (1) The name of the additive, ‘‘ace- (9) Yogurt and yogurt-type products. tone peroxides’’. (10) Frozen and refrigerated desserts. (2) The concentration of the additive (11) Sweet sauces, toppings, and syr- expressed in hydrogen peroxide equiva- ups. lents per 100 grams. (12) Alcoholic beverages. (3) Adequate use directions to provide (13) Nonalcoholic beverages, includ- a final product that complies with the ing beverage bases. limitations prescribed in paragraph (c) (d) If the food containing the additive of this section. is represented to be for special dietary § 172.804 Aspartame. uses, it shall be labeled in compliance The food additive aspartame may be with part 105 of this chapter. safely used in food in accordance with (e) The additive shall be used in ac- good manufacturing practice as a cordance with current good manufac- sweetening agent and a flavor enhancer turing practice in an amount not to ex- in foods for which standards of identity ceed that reasonably required to ac- established under section 401 of the act complish the intended effect. do not preclude such use under the fol- [53 FR 28382, July 28, 1988, as amended at 57 lowing conditions: FR 57961, Dec. 8, 1992; 59 FR 61540, 61543, 61545, (a) Aspartame is the chemical 1- Dec. 1, 1994; 60 FR 21702, May 3, 1995; 63 FR methyl N-L-α-aspartyl-L-phenylalanine 36362, July 6, 1998] (C14H18N2O5). 71
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(b) The additive meets the specifica- (2) The label of any food containing tions of the ‘‘Food Chemicals Codex,’’ the additive shall bear, either on the 3d Ed. (1981) pp. 28–29 and First Supple- principal display panel or on the infor- ment p. 5, which is incorporated by ref- mation panel, the following statement: erence in accordance with 5 U.S.C. PHENYLKETONURICS: CONTAINS 552(a). Copies are available from the PHENYLALANINE National Academy Press, 2101 Constitu- tion Ave. NW., Washington, DC 20418, The statement shall appear in the la- or may be examined at the Center for beling prominently and conspicuously Food Safety and Applied Nutrition’s as compared to other words, state- Library, Food And Drug Administra- ments, designs or devices and in bold tion, 200 C St. SW., rm. 3321, Wash- type and on clear contrasting back- ington, DC, or at the Office of the Fed- ground in order to render it likely to eral Register, 800 North Capitol St. be read and understood by the ordinary NW., suite 700, Washington, DC. individual under customary conditions (c)(1) When aspartame is used as a of purchase and use. sugar substitute tablet for sweetening (3) When the additive is used in a hot beverages, including coffee and tea, sugar substitute for table use, its label L-leucine may be used as a lubricant in shall bear instructions not to use in the manufacture of such tablets at a cooking or baking. level not to exceed 3.5 percent of the (4) Packages of the dry, free-flowing weight of the tablet. additive shall prominently display the (2) When aspartame is used in baked sweetening equivalence in teaspoons of goods and baking mixes, the amount of sugar. the additive is not to exceed 0.5 percent (e) If the food containing the additive by weight of ready-to-bake products or purports to be or is represented for spe- of finished formulations prior to bak- cial dietary uses, it shall be labeled in ing. Generally recognized as safe compliance with part 105 of this chap- (GRAS) ingredients or food additives ter.
approved for use in baked goods shall EDITORIAL NOTE: For FEDERAL REGISTER ci- be used in combination with aspartame tations affecting § 172.804, see the List of CFR to ensure its functionality as a sweet- Sections Affected, which appears in the ener in the final baked product. The Finding Aids section of the printed volume level of aspartame used in these prod- and on GPO Access. ucts is determined by an analytical method entitled ‘‘Analytical Method § 172.806 Azodicarbonamide. for the Determination of Aspartame The food additive azodicarbonamide and Diketopiperazine in Baked Goods may be safely used in food in accord- and Baking Mixes,’’ October 8, 1992, ance with the following prescribed con- which was developed by the Nutrasweet ditions: Co. Copies are available from the Office (a) It is used or intended for use: of Premarket Approval (HFS–200), Cen- (1) As an aging and bleaching ingre- ter for Food Safety and Applied Nutri- dient in cereal flour in an amount not tion, 200 C St. SW., Washington, DC to exceed 2.05 grams per 100 pounds of 20204, or are available for inspection at flour (0.0045 percent; 45 parts per mil- the Center for Food Safety and Applied lion). Nutrition’s Library, Food and Drug Ad- (2) As a dough conditioner in bread ministration, 200 C St. SW., rm. 3321, baking in a total amount not to exceed Washington, DC 20204, and the Office of 0.0045 percent (45 parts per million) by the Federal Register, 800 North Capitol weight of the flour used, including any St. NW., suite 700, Washington, DC. quantity of azodicarbonamide added to (d) To assure safe use of the additive, flour in accordance with paragraph in addition to the other information re- (a)(1) of this section. quired by the Act: (b) To assure safe use of the additive: (1) The principal display panel of any (1) The label and labeling of the addi- intermediate mix of the additive for tive and any intermediate premix pre- manufacturing purposes shall bear a pared therefrom shall bear, in addition statement of the concentration of the to the other information required by additive contained therein; the Act, the following:
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(i) The name of the additive. succinate for fumaric acid as pre- (ii) A statement of the concentration scribed in § 172.810. or the strength of the additive in any (3) The additive identified in para- intermediate premixes. graph (a)(3) of this section is used: (2) The label or labeling of the food (i) As a surfactant and defoaming additive shall also bear adequate direc- agent, at levels not to exceed 0.05 per- tions for use. cent by weight, in scald baths for poul- try defeathering, followed by potable § 172.808 Copolymer condensates of water rinse. The temperatures of the ethylene oxide and propylene oxide. scald baths shall be not less than 125 Copolymer condensates of ethylene °F. oxide and propylene oxide may be safe- (ii) As a foam control and rinse adju- ly used in food under the following pre- vant in hog dehairing machines at a scribed conditions: use level of not more than 5 grams per (a) The additive consists of one of the hog. following: (4) The additive identified in para- (1) α-Hydro-omega-hydroxy-poly (oxy- graph (a)(4) of this section is used as a ethylene) poly(oxypropylene)-(55–61 dough conditioner in yeast-leavened moles)poly(oxyethylene) block copoly- bakery products for which standards of mer, having a molecular weight range identity established under section 401 of 9,760–13,200 and a cloud point above of the Act do not preclude such use, 100 °C in 1 percent aqueous solution. provided that the amount of the addi- (2) α-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) α-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 (β-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) α-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, 200 C St. SW., Washington, DC 20204, or provided that the weight of the addi- may be examined at the Center for tive does not exceed the weight of the Food Safety and Applied Nutrition’s flavoring oils in the flavor concentrate. Library, Food and Drug Administra- (2) The additive identified in para- tion, 200 C St. SW., rm. 3321, Wash- graph (a)(2) of this section is used as a ington, DC, or at the Office of the Fed- processing aid and wetting agent in eral Register, 800 North Capitol St. combination with dioctyl sodium sulfo- NW., suite 700, Washington, DC.
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(1) Positive for curdlan. million of the additive and the finished (2) Assay for curdlan (calculated as beverage or fruit juice drink will con- anhydrous glucose), not less than 80 tain not in excess of 10 parts per mil- percent. lion of the additive. (3) pH of 1 percent aqueous suspen- (b) As a processing aid in sugar fac- sion, 6.0–7.5. tories in the production of unrefined (4) Lead, not more than 0.5 mg/kg. cane sugar, in an amount not in excess (5) Heavy metals (as Pb), not more of 0.5 part per million of the additive than 0.002 percent. per percentage point of sucrose in the (6) Total nitrogen, not more than 0.2 percent. juice, syrup, or massecuite being proc- (7) Loss on drying, not more than 10 essed, and so used that the final molas- percent. ses will contain no more than 25 parts (8) Residue on ignition, not more per million of the additive. than 6 percent. (c) As a solubilizing agent on gums (9) Gel strength of 2 percent aqueous and hydrophilic colloids to be used in suspension, not less than 600x103 dyne food as stabilizing and thickening per square centimeter. agents, when standards of identity do (10) Aerobic plate count, not more not preclude such use. The additive is than 103 per gram. used in an amount not to exceed 0.5 (11) Coliform bacteria, not more than percent by weight of the gums or hy- 3 per gram. drophilic colloids. (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 standards of identity established under per million of the finished beverage. section 401 of the act do not preclude (e) As a dispersing agent in ‘‘cocoa such use. with dioctyl sodium sulfosuccinate for manufacturing’’ that conforms to the [61 FR 65941, Dec. 16, 1996] provisions of § 163.117 of this chapter § 172.810 Dioctyl sodium sulfosuc- and the use limitations prescribed in cinate. § 172.520, in an amount not to exceed 0.4 The food additive dioctyl sodium percent by weight thereof. sulfosuccinate, which meets the speci- (f) As a processing aid and wetting fications of the Food Chemicals Codex, agent in combination with α-hydro- 3d Ed. (1981), pp. 102–104, which is incor- omega -hydroxy - poly(oxyethylene) - porated by reference (copies may be ob- poly-(oxypropylene) (53–59 moles) tained from the National Academy poly(oxyethylene) (14–16 moles) block Press, 2101 Constitution Ave. NW., copolymer, having a molecular weight Washington, DC 20418, or may be exam- range of 3,500–4,125 and a cloud point of ined at the Office of the Federal Reg- 9 °C–12 °C in 10 percent aqueous solu- ister, 800 North Capitol Street, NW., tion, for fumaric acid used in fumaric suite 700, Washington, DC 20408), may acid-acidulated dry beverage base and be safely used in food in accordance in fumaric acid-acidulated fruit juice with the following prescribed condi- drinks, when standards of identity do tions: not preclude such use. The labeling of (a) As a wetting agent in the fol- the dry beverage base shall bear ade- lowing fumaric acid-acidulated foods: quate directions for use, and the addi- Dry gelatin dessert, dry beverage base, tives shall be used in such an amount and fruit juice drinks, when standards that the finished beverage or fruit juice of identity do not preclude such use. drink will contain not in excess of a The labeling of the dry gelatin dessert total of 10 parts per million of the and dry beverage base shall bear ade- dioctyl sodium sulfosuccinate-block quate directions for use, and the addi- copolymer combination. tive shall be used in such an amount that the finished gelatin dessert will [42 FR 14491, Mar. 15, 1977, as amended at 49 contain not in excess of 15 parts per FR 10105, Mar. 19, 1984]
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§ 172.811 Glyceryl tristearate. § 172.812 Glycine. The food additive glyceryl tristearate The food additive glycine may be may be safely used in food in accord- safely used for technological purposes ance with the following prescribed con- in food in accordance with the fol- ditions: lowing prescribed conditions: (a) The food additive (CAS Reg. No. (a) The additive complies with the 555–43–1) is prepared by reacting stearic specifications of the ‘‘Food Chemicals acid with glycerol in the presence of a Codex,’’ 3d Ed. (1981), p. 140, which is in- suitable catalyst. corporated by reference. Copies may be (b) The food additive meets the fol- obtained from the National Academy lowing specifications: Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be exam- Acid number: Not to exceed 1.0. ined at the Office of the Federal Reg- Iodine number: Not to exceed 1.0. ister, 800 North Capitol Street, NW., Saponification number: 186–192. Hydroxyl number: Not to exceed 5.0. suite 700, Washington, DC 20408. Free glycerol content: Not to exceed 0.5 per- (b) The additive is used or intended cent. for use as follows: Unsaponifiable matter: Not to exceed 0.5 per- cent. Uses Limitations ° ° Melting point (Class II): 69 C–73 C. As a masking agent for the Not to exceed 0.2 percent in bitter aftertaste of sac- the finished beverage. (c) The additive is used or intended charin used in manufac- for use as follows when standards of tured beverages and bev- identity established under section 401 erage bases. of the Act do not preclude such use: As a stabilizer in mono- and Not to exceed 0.02 percent of diglycerides prepared by the mono- and the glycerolysis of edible diglycerides. Uses Limitations fats or oils. 1. As a crystallization accel- Not to exceed 1 percent of erator in cocoa products, in the combined weight of (c) To assure safe use of the additive, imitation chocolate, and in the formulation. in addition to the other information re- compound coatings. 2. As a formulation aid as de- Not to exceed 0.5 percent. quired by the Act: fined in § 170.3(o)(14) of this (1) The labeling of the additive shall chapter, lubricant and release bear adequate directions for use of the agent as defined in § 170.3(o)(18) of this chapter, additive in compliance with the provi- and surface-finishing agent as sions of this section. defined in § 170.3(o)(30) of (2) The labeling of beverage bases this chapter in food. containing the additive shall bear ade- 3. As a formulation aid as de- Not to exceed 3.0 percent fined in § 170.3(o)(14) of this of the combined weight quate directions for use to provide that chapter in confections. of the formulation. beverages prepared therefrom shall 4. As a formulation aid as de- Not to exceed 1.0 percent contain no more than 0.2 percent gly- fined in § 170.3(o)(14) of this of the combined weight cine. chapter in fats and oils as de- of the formulation. fined in § 170.3 (n)(12) of this [42 FR 14491, Mar. 15, 1977, as amended at 49 chapter. FR 10105, Mar. 19, 1984] 5. As a winterization and frac- Not to exceed 0.5 percent tionation aid in fat and oil by weight of the proc- processing. essed fat or oil. § 172.814 Hydroxylated lecithin. The food additive hydroxylated (d) To assure safe use of the additive: lecithin may be safely used as an emul- (1) In addition to the other informa- sifier in foods in accordance with the tion required by the act, the label or following conditions: labeling of the additive shall bear the (a) The additive is obtained by the name of the additive. treatment of lecithin in one of the fol- (2) The label of the additive shall lowing ways, under controlled condi- bear adequate directions to provide a tions whereby the separated fatty acid final product that complies with the fraction of the resultant product has limitations prescribed in paragraph (c) an acetyl value of 30 to 38: of this section. (1) With hydrogen peroxide, benzoyl [53 FR 21632, June 9, 1988, as amended at 59 peroxide, lactic acid, and sodium hy- FR 24924, May 13, 1994] droxide.
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(2) With hydrogen peroxide, acetic (b) It is used or intended for use as a acid, and sodium hydroxide. crystallization inhibitor in vegetable (b) It is used or intended for use, in oils and as a release agent in vegetable accordance with good manufacturing oils and vegetable shortenings, where- practice, as an emulsifier in foods, ex- by the additive does not exceed 0.125 cept for those standardized foods that percent of the combined weight of the do not provide for such use. oil or shortening. (c) To assure safe use of the additive, (c) To insure safe use of the additive, the label of the food additive container the label and labeling of the additive shall bear, in addition to the other in- container shall bear, in addition to the formation required by the Act: other information required by the Act: (1) The name of the additive, (1) The name of the additive. ‘‘hydroxylated lecithin’’. (2) Adequate directions to provide an (2) Adequate directions for its use. oil or shortening that complies with the limitations prescribed in paragraph § 172.816 Methyl glucoside-coconut oil (b) of this section. ester. 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: Polyethylene glycol identified in this (a) It is the methyl glucoside-coconut section may be safely used in food in oil ester having the following specifica- accordance with the following pre- tions: scribed 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 heat- ing hydrogenated cottonseed or soy- ANALYTICAL METHOD bean oil under controlled conditions, in ETHYLENE GLYCOL AND DIETHYLENE GLYCOL the presence of air and a suitable cata- CONTENT OF POLYETHYLENE GLYCOLS lyst which is not a food additive as so The analytical method for determining defined. The resultant product meets ethylene glycol and diethylene glycol is as the following specifications: follows: Acid number: Maximum 15. APPARATUS Iodine number: Maximum 15. 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:
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Column temperature: 165 °C. Percent ethylene glycol=(E×B)/(A × sample Inlet temperature: 260 °C. weight in grams) Carrier gas (nitrogen) flow rate: 70 milli- Percent diethylene glycol=(F × D)/(C × sam- liters per minute. ple weight in grams) Hydrogen and air flow to burner: Optimize to give maximum sensitivity. (c) Uses. It may be used, except in Sample size: 2 microliters. milk or preparations intended for addi- Elution time: Ethylene glycol: 2.0 minutes. tion to milk, as follows: Diethylene glycol: 6.5 minutes. (1) As a coating, binder, plasticizing ¥ Recorder: 0.5 to +1.05 millivolt, full span, agent, and/or lubricant in tablets used 1 second full response time. Syringe: 10-microliter (Hamilton 710 N or for food. equivalent). (2) As an adjuvant to improve flavor Chromatograph column: 5 feet × 1⁄8 inch. and as a bodying agent in nonnutritive I.D. stainless steel tube packed with sorbitol sweeteners identified in § 180.37 of this (Mathieson-Coleman-Bell 2768 Sorbitol chapter. 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 Carrier gas, nitrogen: Commercial grade in amount not greater than that required 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 volume in a 10-milliliter volumetric flask is cordance with the following conditions: 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- ene glycol peak. whites whereby the additive does not 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 mil- liliter 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 chromatograph. Measure the heights, in mil- not exceed 25 parts per million of the limeters, 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
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under section 401 of the Act precludes section shall be labeled to show the such use. presence of the additive and its label or (ii) Fumaric acid-acidulated fruit labeling shall bear adequate directions juice drinks whereby the additive does for use. not exceed 25 parts per million of the (2) Sodium nitrite produced in ac- finished fruit juice drink and it is not cordance with paragraph (b)(2) of this used in a fruit juice drink for which a section shall bear the labeling required standard of identity established under by § 172.175 and a statement declaring section 401 of the Act precludes such the presence of sodium mono- and di- use. methyl naphthalene sulfonates. (4) As a wetting agent at a level not to exceed 10 parts per million in the [42 FR 14491, Mar. 15, 1977, as amended at 63 FR 7069, Feb. 12, 1998] partition of high and low melting frac- tions of crude vegetable oils and ani- § 172.826 Sodium stearyl fumarate. mal fats, provided that the partition step is followed by a conventional re- Sodium stearyl fumarate may be fining process that includes alkali neu- safely used in food in accordance with tralization and deodorization of the the following conditions: fats and oils. (a) It contains not less than 99 per- (c) To insure the safe use of the addi- cent sodium stearyl fumarate cal- tive, the label of the food additive con- culated on the anhydrous basis, and tainer shall bear, in addition to the not more than 0.25 percent sodium ste- other information required by the Act: aryl maleate. (1) The name of the additive, sodium (b) The additive is used or intended lauryl sulfate. for use: (2) Adequate use directions to provide (1) As a dough conditioner in yeast- a final product that complies with the leavened bakery products in an amount limitations prescribed in paragraph (b) not to exceed 0.5 percent by weight of of this section. the flour used. (2) As a conditioning agent in dehy- [42 FR 14491, Mar. 15, 1977, as amended at 43 drated potatoes in an amount not to FR 18668, May 2, 1978] exceed 1 percent by weight thereof. § 172.824 Sodium mono- and dimethyl (3) As a stabilizing agent in naphthalene sulfonates. nonyeast-leavened bakery products in The food additive sodium mono- and an amount not to exceed 1 percent by dimethyl naphthalene sulfonates may weight of the flour used. be safely used in accordance with the (4) As a conditioning agent in proc- following prescribed conditions: essed cereals for cooking in an amount (a) The additive has a molecular not to exceed 1 percent by weight of weight range of 245–260. the dry cereal, except for foods for (b) The additive is used or intended which standards of identity preclude for use: such use. (1) In the crystallization of sodium (5) As a conditioning agent in starch- carbonate in an amount not to exceed thickened or flour-thickened foods in 250 parts per million of the sodium car- an amount not to exceed 0.2 percent by bonate. Such sodium carbonate is used weight of the food. or intended for use in potable water systems to reduce hardness and aid in § 172.828 Acetylated monoglycerides. sedimentation and coagulation by rais- The food additive acetylated ing the pH for the efficient utilization monoglycerides may be safely used in of other coagulation materials. or on food in accordance with the fol- (2) As an anticaking agent in sodium lowing prescribed conditions: nitrite at a level not in excess of 0.1 (a) The additive is manufactured by: percent by weight thereof for author- (1) The interesterification of edible ized uses in cured fish and meat. fats with triacetin and in the presence (c) In addition to the general labeling of catalytic agents that are not food requirements of the Act: additives or are authorized by regula- (1) Sodium carbonate produced in ac- tion, followed by a molecular distilla- cordance with paragraph (b)(1) of this tion or by steam stripping; or
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(2) The direct acetylation of edible corporated by reference in accordance monoglycerides with acetic anhydride with 5 U.S.C. 552(a) and 1 CFR part 51. without the use of catalyst or molec- Copies are available from the the Divi- ular distillation, and with the removal sion of Product Policy (HFS–206), Cen- by vacuum distillation, if necessary, of ter for Food Safety and Applied Nutri- the acetic acid, acetic anhydride, and tion, Food and Drug Administration, triacetin. 200 C St. SW., Washington, DC 20204– (b) The food additive has a Reichert- 0001, or may be examined at the Center Meissl value of 75–200 and an acid value for Food Safety and Applied Nutri- of less than 6. tion’s Library, 200 C St. SW., rm. 3321, (c) The food additive is used at a Washington, DC 20204–0001, or the Of- level not in excess of the amount rea- fice of the Federal Register, 800 North sonably required to produce its in- Capitol St. NW., suite 700, Washington, tended effect in food, or in food-proc- DC. essing, food-packing, or food-storage (c) The additive may be used as a equipment. sweetener in foods generally, in accord- [42 FR 14491, Mar. 15, 1977, as amended at 50 ance with current good manufacturing FR 3508, Jan. 25, 1985] practice in an amount not to exceed that reasonably required to accomplish § 172.830 Succinylated monoglycerides. the intended effect. The food additive succinylated (d) If the food containing the additive monoglycerides may be safely used in purports to be or is represented to be food in accordance with the following for special dietary use, it shall be la- prescribed conditions: beled in compliance with part 105 of (a) The additive is a mixture of semi- this chapter. and neutral succinic acid esters of mono- and diglycerides produced by the [63 FR 16433, Apr. 3, 1998, as amended at 64 succinylation of a product obtained by FR 43909, Aug. 12, 1999] the glycerolysis of edible fats and oils, or by the direct esterification of glyc- § 172.832 Monoglyceride citrate. erol with edible fat-forming fatty A food additive that is a mixture of acids. glyceryl monooleate and its citric acid (b) The additive meets the following monoester manufactured by the reac- specifications: tion of glyceryl monooleate with citric Succinic acid content: 14.8%–25.6% acid under controlled conditions may Melting point: 50 °C–60 °C. be safely used as a synergist and solu- Acid number: 70–120 bilizer for antioxidants in oils and fats, (c) The additive is used or intended when used in accordance with the con- for use in the following foods: ditions prescribed in this section. (1) As an emulsifier in liquid and (a) The food additive meets the fol- plastic shortenings at a level not to ex- lowing specifications: ceed 3 percent by weight of the short- Acid number, 70–100. ening. Total citric acid (free and combined), 14 per- (2) As a dough conditioner in bread cent–17 percent. baking, when such use is permitted by an appropriate food standard, at a level (b) It is used, or intended for use, in not to exceed 0.5 percent by weight of antioxidant formulations for addition the flour used. to oils and fats whereby the additive does not exceed 200 parts per million of § 172.831 Sucralose. the combined weight of the oil or fat (a) Sucralose is the chemical 1,6- and the additive. dichloro-1,6-dideoxy-β-D- (c) To assure safe use of the additive: fructofuranosyl-4-chloro-4-deoxy-α-D- (1) The container label shall bear, in galactopyranoside (CAS Reg. No. 56038– addition to the other information re- 13–2). quired by the Act, the name of the ad- (b) The additive meets the specifica- ditive. tions of the ‘‘Food Chemicals Codex,’’ (2) The label or accompanying label- 4th ed. (1996), pp. 398–400, which is in- ing shall bear adequate directions for
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the use of the additive which, if fol- tion for availability of the incorpora- lowed, will result in a food that com- tion by reference. plies with the requirements of this sec- (4) Lead: Not to exceed 1.0 milli- tion. grams/kilogram determined by the ‘‘Atomic Absorption § 172.833 Sucrose acetate isobutyrate Spectrophotometric Graphite Furnace (SAIB). Method, Method I,’’ in the ‘‘Food Sucrose acetate isobutyrate may be Chemicals Codex,’’ 4th ed. (1996), pp. 763 safely used in foods in accordance with and 764, with an attached modification the following prescribed conditions: to the sample digestion section in Ap- pendix III.B (July 1996), which is incor- (a) Sucrose acetate isobutyrate (CAS porated by reference. Copies are avail- Reg. No. 27216–37–1), or SAIB, is the able from the National Academy Press, chemical alpha-D-glucopyranoside, O- 2101 Constitution Ave. NW., Box 285, acetyl-tris-O-(2-methyl-1-oxopropyl)- Washington, DC 20055 (Internet ‘‘http:// beta-D-fructofuranosyl, acetate tris(2- www.nap.edu’’), or may be examined at methyl propanoate). the Center for Food Safety and Applied (b) SAIB, a pale, straw-colored liquid, Nutrition’s Library, 200 C St. SW., rm. meets the following specifications: (1) 3321, Washington, DC, or at the Office Assay: Not less than 98.8 percent and of the Federal Register, 800 North Cap- not more than 101.9 percent, based on itol St. NW., suite 700, Washington, DC. the following formula: (5) Triacetin: Not to exceed 0.10 per- Assay = ((SV 0.10586) ÷ 56.1) x 100 cent determined by gas chroma- Where SV = Saponification value tography as described in the ‘‘Guide to (2) Saponification value: 524–540 de- Specifications for General Notices, termined using 1 gram of sample by the General Analytical Techniques, Identi- ‘‘Guide to Specifications for General fication Tests, Test Solutions, and Notices, General Analytical Tech- Other Reference Materials,’’ in the niques, Identification Tests, Test Solu- ‘‘Compendium of Food Additive Speci- tions, and Other Reference Materials,’’ fications, Addendum 4, FAO Food and in the ‘‘Compendium of Food Additive Nutrition Paper 5, Revision 2,’’ (1991), Specifications, Addendum 4, Food and pp. 13–26, which is incorporated by ref- Agriculture Organization of the United erence; see paragraph (b)(2) of this sec- Nations (FAO), Food and Nutrition tion for availability of the incorpora- Paper 5, Revision 2’’ (1991), pp. 203 and tion by reference. 204, which is incorporated by reference, (c) The food additive is used as a sta- in accordance with 5 U.S.C. 552(a) and 1 bilizer (as defined in § 170.3(o)(28) of this CFR part 51. Copies are available from chapter) of emulsions of flavoring oils the Office of Premarket Approval, Cen- in nonalcoholic beverages. ter for Food Safety and Applied Nutri- (d) The total SAIB content of a bev- tion (HFS–200), Food and Drug Admin- erage containing the additive does not istration, 200 C St. SW., Washington, exceed 300 milligrams/kilogram of the DC 20204, or may be examined at the finished beverage. Center for Food Safety and Applied Nu- [64 FR 29958, June 4, 1999; 64 FR 43072, Aug. 9, trition’s Library, 200 C St. SW., rm. 1999] 3321, Washington, DC, or at the Office of the Federal Register, 800 North Cap- § 172.834 Ethoxylated mono- and itol St. NW., suite 700, Washington, DC. diglycerides. (3) Acid value: Not to exceed 0.20 de- The food additive ethoxylated mono- termined using 50 grams of sample by and diglycerides (polyoxyethylene (20) the ‘‘Guide to Specifications for Gen- mono- and diglycerides of fatty acids) eral Notices, General Analytical Tech- (polyglycerate 60) may be safely used niques, Identification Tests, Test Solu- in food in accordance with the fol- tions, and Other Reference Materials,’’ lowing prescribed conditions: in the ‘‘Compendium of Food Additive (a) The food additive is manufactured Specifications, Addendum 4, FAO Food by: and Nutrition Paper 5, Revision 2,’’ p. (1) Glycerolysis of edible fats pri- 189 (1991), which is incorporated by ref- marily composed of stearic, palmitic, erence; see paragraph (b)(2) of this sec- and myristic acids; or
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(2) Direct esterification of glycerol accordance with the following pre- with a mixture of primarily stearic, scribed conditions: palmitic, and myristic acids; (a) The food additive is manufactured by reacting stearic acid (usually con- to yield a product with less than 0.3 taining associated fatty acids, chiefly acid number and less than 0.2 percent palmitic) with sorbitol to yield a prod- water, which is then reacted with uct with a maximum acid number of 10 ethylene oxide. and a maximum water content of 0.2 (b) The additive meets the following percent, which is then reacted with specifications: ethylene oxide. Saponification number, 65–75. (b) The food additive meets the fol- Acid number, 0–2. lowing specifications: Hydroxyl number, 65–80. Saponification number 45–55. Oxyethylene content, 60.5–65.0 percent. Acid number 0–2. (c) The additive is used or intended Hydroxyl number 81–96. for use in the following foods when Oxyethylene content 65 percent–69.5 percent. standards of identity established under (c) It is used or intended for use as section 401 of the Act do not preclude follows: such use: (1) As an emulsifier in whipped edible oil topping with or without one or a Use Limitations combination of the following: 1. As an emulsifier in pan-re- Not to exceed levels required (i) Sorbitan monostearate; lease agents for and as a to produce the intended ef- (ii) Polysorbate 65; dough conditioner in yeast- fects, total not to exceed (iii) Polysorbate 80; leavened bakery products. 0.5 percent by weight of the flour used. whereby the maximum amount of the 2. As an emulsifier in cakes Not to exceed 0.5 percent by additive or additives used does not ex- and cake mixes. weight of the dry ingredi- ents. ceed 0.4 percent of the weight of the 3. As an emulsifier in Not to exceed 0.45 percent finished whipped edible oil topping; ex- whipped vegetable oil top- by weight of the finished cept that a combination of the additive pings and topping mixes. whipped vegetable oil top- pings. with sorbitan monostearate may be 4. As an emulsifier in icings Not to exceed 0.5 percent by used in excess of 0.4 percent, provided and icing mixes. weight of the finished that the amount of the additive does icings. not exceed 0.77 percent and the amount 5. As an emulsifier in frozen Not to exceed 0.2 percent by desserts. weight of the finished fro- of sorbitan monostearate does not ex- zen desserts. ceed 0.27 percent of the weight of the 6. As an emulsifier in edible Not to exceed 0.4 percent by finished whipped edible oil topping. vegetable fat-water emul- weight of the finished vege- (2) As an emulsifier in cakes and cake sions intended for use as table fat-water emulsions. substitutes for milk or mixes, with or without one or a com- cream in beverage coffee. bination of the following: (i) Polysorbate 65. (d) When the name ‘‘polyglycerate (ii) Sorbitan monostearate. 60’’ is used in labeling it shall be fol- When used alone, the maximum lowed by either ‘‘polyoxyethylene (20) amount of polysorbate 60 shall not ex- mono-and diglycerides of fatty acids’’ ceed 0.46 percent of the cake or cake or ‘‘ethoxylated mono- and mix, on a dry-weight basis. When used diglycerides’’ in parentheses. with polysorbate 65 and/or sorbitan [42 FR 14491, Mar. 15, 1977, as amended at 42 monostearate, it shall not exceed 0.46 FR 37973, July 26, 1977; 50 FR 49536, Dec. 3, percent, nor shall the polysorbate 65 1985] exceed 0.32 percent or the sorbitan monostearate exceed 0.61 percent, and § 172.836 Polysorbate 60. no combination of these emulsifiers The food additive polysorbate 60 shall exceed 0.66 percent of the cake or (polyoxyethylene (20) sorbitan mono- cake mix, all calculated on a dry- stearate) which is a mixture of weight basis. polyoxyethylene ethers of mixed par- (3) As an emulsifier, alone or in com- tial stearic and palmitic acid esters of bination with sorbitan monostearate, sorbitol anhydrides and related com- in nonstandardized confectionery coat- pounds, may be safely used in food in ings and standardized cacao products
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specified in §§ 163.123, 163.130, 163.135, does not exceed 1 percent of the fin- 163.140, 163.145, and 163.150 of this chap- ished shortening or oil. ter, as follows: (iii) The 1–percent limitation speci- (i) It is used alone in an amount not fied in paragraph (c)(8) (i) and (ii) of to exceed 0.5 percent of the weight of this section may be exceeded in premix the finished nonstandardized confec- concentrates of shortening or edible oil tionery coating or standardized cacao if the labeling complies with the re- product. quirements of paragraph (d) of this sec- (ii) It is used with sorbitan mono- tion. stearate in any combination of up to (9) As an emulsifier in solid-state, ed- 0.5 percent of polysorbate 60 and up to ible vegetable fat-water emulsions in- 1 percent of sorbitan monostearate: tended for use as substitutes for milk Provided, That the total combination or cream in beverage coffee, with or does not exceed 1 percent of the weight without one or a combination of the of the finished nonstandardized confec- following: tionery coating or standardized cacao (i) Polysorbate 65. product. (ii) Sorbitan monostearate. (4) [Reserved] The maximum amount of the additive (5) As an emulsifier in cake icings or additives shall not exceed 0.4 per- and cake fillings, with or without one cent by weight of the finished edible or a combination of the following: vegetable fat-water emulsion. (i) Polysorbate 65. (10) As a foaming agent in non- (ii) Sorbitan monostearate. alcoholic mixes, to be added to alco- When used alone, the maximum holic beverages in the preparation of amount of polysorbate 60 shall not ex- mixed alcoholic drinks, at a level not ceed 0.46 percent of the weight of the to exceed 4.5 percent by weight of the cake icings and cake fillings. When nonalcoholic mix. used with polysorbate 65 and/or sorbi- (11) As a dough conditioner in yeast- tan monostearate, it shall not exceed leavened bakery products in an amount 0.46 percent, nor shall the polysorbate not to exceed 0.5 percent by weight of 65 exceed 0.32 percent or the sorbitan the flour used. monostearate exceed 0.7 percent, and (12) As an emulsifier, alone or in no combination of these emulsifiers combination with sorbitan monostea- shall exceed 1 percent of the weight of rate, in the minimum quantity re- the cake icing or cake filling. quired to accomplish the intended ef- (6) To impart greater opacity to fect, in formulations of white mineral sugar-type confection coatings where- oil conforming with § 172.878 and/or pe- by the maximum amount of the addi- troleum wax conforming with § 172.886 tive does not exceed 0.2 percent of the for use as protective coatings on raw weight of the finished sugar coating. fruits and vegetables. (7) As an emulsifier in nonstandard- (13) As a dispersing agent in artifi- ized dressings whereby the maximum cially sweetened gelatin desserts and in amount of the additive does not exceed artificially sweetened gelatin dessert 0.3 percent of the weight of the finished mixes, whereby the amount of the addi- dressings. tive does not exceed 0.5 percent on a (8) As an emulsifier, alone or in com- dry-weight basis. bination with polysorbate 80, in (14) As an emulsifier in chocolate fla- shortenings and edible oils intended for vored syrups, whereby the maximum use in foods as follows, when standards amount of the additive does not exceed of identity established under section 0.05 percent in the finished product. 401 of the act do not preclude such use: (15) As a surfactant and wetting (i) It is used alone in an amount not agent for natural and artificial colors to exceed 1 percent of the weight of the in food as follows: finished shortening or oil. (i) In powdered soft drink mixes in an (ii) It is used with polysorbate 80 in amount not to exceed 4.5 percent by any combination providing no more weight of the mix. than 1 percent of polysorbate 60 and no (ii) In sugar-based gelatin dessert more than 1 percent of polysorbate 80, mixes in an amount not to exceed 0.5 provided that the total combination percent by weight of the mix.
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(iii) In artificially sweetened gelatin Oxyethylene content 46 percent–50 percent. dessert mixes in an amount not to ex- (c) The additive is used, or intended ceed 3.6 percent by weight of the mix. for use, as follows: (iv) In sugar-based pudding mixes in (1) As an emulsifier in ice cream, fro- an amount not to exceed 0.5 percent by weight of the mix. zen custard, ice milk, fruit sherbet and (v) In artificially sweetened pudding nonstandardized frozen desserts when mixes in an amount not to exceed 0.5 used alone or in combination with percent by weight of the mix. polysorbate 80, whereby the maximum (16) As an emulsifier in ice cream, amount of the additives, alone or in frozen custard, fruit sherbet, and non- combination, does not exceed 0.1 per- standardized frozen desserts when used cent of the finished frozen dessert. alone or in combination with poly- (2) As an emulsifier in cakes and cake sorbate 65 and/or polysorbate 80, where- mixes, with or without one or a com- by the maximum amount of the addi- bination of the following: tives, alone or in combination, does not (i) Sorbitan monostearate. exceed 0.1 percent of the finished frozen (ii) Polysorbate 60. dessert. When used alone, the maximum (d) To assure safe use of the additive, amount of polysorbate 65 shall not ex- in addition to the other information re- ceed 0.32 percent of the cake or cake quired by the Act: mix, on a dry-weight basis. When used (1) The label of the additive and any with sorbitan monostearate and/or intermediate premixes shall bear: polysorbate 60, it shall not exceed 0.32 (i) The name of the additive. percent, nor shall the sorbitan mono- (ii) A statement of the concentration stearate exceed 0.61 percent or the or strength of the additive in any in- polysorbate 60 exceed 0.46 percent, and termediate premixes. no combination of these emulsifiers (2) The label or labeling shall bear shall exceed 0.66 percent of the cake or adequate directions to provide a final cake mix, all calculated on a dry- product that complies with the limita- weight basis. tions prescribed in paragraph (c) of this section. (3) As an emulsifier in whipped edible oil topping with or without one or a [42 FR 14491, Mar. 15, 1977, as amended at 43 combination of the following: FR 2871, Jan. 25, 1978; 45 FR 58836, Sept. 5, (i) Sorbitan monostearate; 1980; 46 FR 8466, Jan. 27, 1981; 64 FR 57976, Oct. 28, 1999] (ii) Polysorbate 60; (iii) Polysorbate 80; § 172.838 Polysorbate 65. whereby the maximum amount of the The food additive polysorbate 65 additive or additives used does not ex- (polyoxyethylene (20) sorbitan ceed 0.4 percent of the weight of the tristearate), which is a mixture of finished whipped edible oil topping. polyoxyethylene ethers of mixed ste- (4) As an emulsifier in solid-state, ed- aric acid esters of sorbitol anhydrides ible vegetable fat-water emulsions in- and related compounds, may be safely tended for use as substitutes for milk used in food in accordance with the fol- or cream in beverage coffee, with or lowing prescribed conditions: without one or a combination of the (a) The food additive is manufactured following: by reacting stearic acid (usually con- (i) Sorbitan monostearate. taining associated fatty acids, chiefly (ii) Polysorbate 60. palmitic) with sorbitol to yield a prod- uct with a maximum acid number of 15 The maximum amount of the additive and a maximum water content of 0.2 or additives shall not exceed 0.4 per- percent, which is then reacted with cent by weight of the finished edible ethylene oxide. vegetable fat-water emulsion. (b) The food additive meets the fol- (5) As an emulsifier in cake icings lowing specifications: and cake fillings, with or without one Saponification number 88–98. or a combination of the following: Acid number 0–2. (i) Sorbitan monostearate. Hydroxyl number 44–60. (ii) Polysorbate 60.
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When used alone, the maximum polysorbate 65 whereby the maximum amount of polysorbate 65 shall not ex- amount of the additives, alone or in ceed 0.32 percent of the weight of the combination, does not exceed 0.1 per- cake icing or cake filling. When used cent of the finished frozen dessert. with sorbitan monostearate and/or (2) In yeast-defoamer formulations polysorbate 60, it shall not exceed 0.32 whereby the maximum amount of the percent, nor shall the sorbitan mono- additive does not exceed 4 percent of stearate exceed 0.7 percent or the poly- the finished yeast defoamer and the sorbate 60 exceed 0.46 percent, and no maximum amount of the additive in combination of these emulsifiers shall the yeast from such use does not ex- exceed 1 percent of the weight of the ceed 4 parts per million. cake icing or cake filling. (3) As a solubilizing and dispersing (d) To assure safe use of the additive, agent in pickles and pickle products, in addition to the other information re- whereby the maximum amount of the quired by the Act: additive does not exceed 500 parts per (1) The label of the additive and any million. intermediate premixes shall bear: (4) As a solubilizing and dispersing (i) The name of the additive. agent in: (ii) A statement of the concentration (i) Vitamin-mineral preparations or strength of the additive in any in- containing calcium caseinate in the ab- termediate premixes. sence of fat-soluble vitamins, whereby (2) The label or labeling shall bear the maximum intake of polysorbate 80 adequate directions to provide a final shall not exceed 175 milligrams from product that complies with the limita- the recommended daily dose of the tions prescribed in paragraph (c) of this preparations. section. (ii) Fat-soluble vitamins in vitamin [42 FR 14491, Mar. 15, 1977, as amended at 43 and vitamin-mineral preparations con- FR 2871, Jan. 20, 1978] taining no calcium caseinate, whereby the maximum intake of polysorbate 80 § 172.840 Polysorbate 80. shall not exceed 300 milligrams from The food additive polysorbate 80 the recommended daily dose of the (polyoxyethylene (20) sorbitan preparations. monooleate), which is a mixture of (iii) In vitamin-mineral preparations polyoxyethylene ethers of mixed par- containing both calcium caseinate and tial oleic acid esters of sorbitol anhy- fat-soluble vitamins, whereby the max- drides and related compounds, may be imum intake of polysorbate 80 shall safely used in food in accordance with not exceed 475 milligrams from the rec- the following prescribed conditions: ommended daily dose of the prepara- (a) The food additive is manufactured tions. by reacting oleic acid (usually con- (5) As a surfactant in the production taining associated fatty acids) with of coarse crystal sodium chloride sorbitol to yield a product with a max- whereby the maximum amount of the imum acid number of 7.5 and a max- additive in the finished sodium chlo- imum water content of 0.5 percent, ride does not exceed 10 parts per mil- which is then reacted with ethylene lion. oxide. (6) In special dietary foods, as an (b) The food additive meets the fol- emulsifier for edible fats and oils, with lowing specifications: directions for use which provide for the Saponification number 45–55. ingestion of not more than 360 milli- Acid number 0–2. grams of polysorbate 80 per day. Hydroxyl number 65–80. (7) As a solubilizing and dispersing Oxyethylene content 65 percent–69.5 percent. agent for dill oil in canned spiced green (c) The additive is used or intended beans, not to exceed 30 parts per mil- for use as follows: lion. (1) An emulsifier in ice cream, frozen (8) As an emulsifier, alone or in com- custard, ice milk, fruit sherbet, and bination with polysorbate 60, in nonstandardized frozen desserts, when shortenings and edible oils intended for used alone or in combination with use in foods as follows, when standards
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of identity established under section (14) As a surfactant and wetting 401 of the act do not preclude such use: agent for natural and artificial colors (i) It is used alone in an amount not for use in barbecue sauce where the to exceed 1 percent of the weight of the level of the additive does not exceed finished shortening or oil. 0.005 percent by weight of the barbecue (ii) It is used with polysorbate 60 in sauce. any combination providing no more (d) To assure safe use of the additive, than 1 percent of polysorbate 80 and no in addition to the other information re- more than 1 percent of polysorbate 60, quired by the Act: provided that the total combination (1) The label of the additive and any does not exceed 1 percent of the fin- intermediate premixes shall bear: ished shortening or oil. (i) The name of the additive. (iii) The 1–percent limitation speci- (ii) A statement of the concentration fied in paragraph (c)(8) (i) and (ii) of or strength of the additive in any in- this section may be exceeded in premix termediate premixes. concentrates of shortening or edible oil (2) The label or labeling shall bear if the labeling complies with the re- adequate directions to provide a final quirements of paragraph (d) of this sec- product that complies with the limita- tion. tions prescribed in paragraph (c) of this (9) As an emulsifier in whipped edible section. oil topping with or without one or a [42 FR 14491, Mar. 15, 1977, as amended at 43 combination of the following: FR 2871, Jan. 20, 1978; 45 FR 58835, Sept. 5, (i) Sorbitan monostearate; 1980; 46 FR 8466, Jan. 27, 1981] (ii) Polysorbate 60; § 172.841 Polydextrose. (iii) Polysorbate 65; Polydextrose as identified in this sec- whereby the maximum amount of the tion may be safely used in food in ac- additive or additives used does not ex- cordance with the following prescribed ceed 0.4 percent of the weight of the conditions: finished whipped edible oil topping. (a)(1) Polydextrose (CAS Reg. No. (10) It is used as a wetting agent in 68424–04–4) is a partially metabolizable scald water for poultry defeathering, water-soluble polymer prepared by the followed by potable water rinse. The condensation of a melt which consists concentration of the additive in the either of approximately 89 percent D- scald water does not exceed 0.0175 per- glucose, 10 percent sorbitol, and 1 per- cent. cent citric acid or of approximately 90 (11) As a dispersing agent in gelatin percent D-glucose, 10 percent sorbitol, desserts and in gelatin dessert mixes, and 0.1 percent phosphoric acid, on a whereby the amount of the additive weight basis. does not exceed 0.082 percent on a dry- (2) Polydextrose may be partially weight basis. neutralized with potassium hydroxide, (12) As an adjuvant added to herbi- or partially reduced by transition cide use and plant-growth regulator metal catalytic hydrogenation in aque- use dilutions by a grower or applicator ous solution. prior to application of such dilutions to (b) The additive meets the specifica- the growing crop. Residues resulting tions of the ‘‘Food Chemicals Codex,’’ from such use are exempt from the re- 4th ed. (1996), pp. 297–300, which is in- quirement of a tolerance. When so used corporated by reference in accordance or intended for use, the additive shall with 5 U.S.C. 552(a) and 1 CFR part 51. be exempt from the requirements of Copies are available from the National paragraph (d)(1) of this section. Academy Press, 2101 Constitution Ave. (13) As a defoaming agent in the prep- NW., Washington, DC 20418, or may be aration of the creaming mixture for examined at the Center for Food Safety cottage cheese and lowfat cottage and Applied Nutrition’s Library, Food cheese, as identified in §§ 133.128 and and Drug Administration, 200 C St. 133.131 of this chapter, respectively, SW., rm. 3321, Washington, DC, or at whereby the amount of the additive the Office of the Federal Register, 800 does not exceed .008 percent by weight North Capitol St. NW., suite 700, Wash- of the finished products. ington, DC.
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(c) Polydextrose is used in accord- Acid number, 5–10 ance with current good manufacturing Hydroxyl number, 235–260 practices as a bulking agent, formula- (c) It is used or intended for use, tion aid, humectant, and texturizer in alone or in combination with poly- the following foods when standards of sorbate 60 as follows: identity established under section 401 (1) As an emulsifier in whipped edible of the act do not preclude such use: oil topping with or without one or a (1) Baked goods and baking mixes (re- combination of the following: stricted to fruit, custard, and pudding- (i) Polysorbate 60; filled pies, cakes, cookies, and similar (ii) Polysorbate 65; baked products); (iii) Polysorbate 80; (2) Chewing gum; (3) Confections and frostings; whereby the maximum amount of the (4) Dressings for salads; additive or additives used does not ex- (5) Film coatings on single and mul- ceed 0.4 percent of the weight of the tiple vitamin and mineral supplement finished whipped edible oil topping; ex- tablets; cept that a combination of the additive (6) Frozen dairy desserts and mixes; with polysorbate 60 may be used in ex- (7) Fruit and water ices; cess of 0.4 percent: Provided, That the (8) Fruit spreads; amount of the additive does not exceed (9) Gelatins, puddings and fillings; 0.27 percent and the amount of poly- (10) Hard and soft candy; sorbate 60 does not exceed 0.77 percent (11) Peanut spread; of the weight of the finished whipped (12) Sweet sauces, toppings, and syr- edible oil topping. ups; (2) As an emulsifier in cakes and cake (13) Tablespreads. mixes, with or without one or a com- (d) If the food containing the additive bination of the following: purports to be or is represented for spe- (i) Polysorbate 65. cial dietary uses, it shall be labeled in (ii) Polysorbate 60. compliance with part 105 of this chap- When used alone, the maximum ter. amount of sorbitan monostearate shall (e) The label and labeling of food a not exceed 0.61 percent of the cake or single serving of which would be ex- cake mix, on a dry-weight basis. When pected to exceed 15 grams of the addi- used with polysorbate 65 and/or poly- tive shall bear the statement: ‘‘Sen- sorbate 60, it shall not exceed 0.61 per- sitive individuals may experience a cent, nor shall the polysorbate 65 ex- laxative effect from excessive con- ceed 0.32 percent or the polysorbate 60 sumption of this product’’. exceed 0.46 percent, and no combina- [46 FR 30081, June 5, 1981, as amended at 59 tion of the emulsifiers shall exceed 0.66 FR 37421, July 22, 1994; 60 FR 54425, Oct. 24, percent of the weight of the cake or 1995; 61 FR 14480, Apr. 2, 1996; 62 FR 30985, cake mix, calculated on a dry-weight June 6, 1997; 63 FR 57597, Oct. 28, 1998; 65 FR basis. 64605, Oct. 30, 2000; 65 FR 79719, Dec. 20, 2000] (3) As an emulsifier, alone or in com- § 172.842 Sorbitan monostearate. bination with polysorbate 60 in non- standardized confectionery coatings The food additive sorbitan monostea- and standardized cacao products speci- rate, which is a mixture of partial ste- fied in §§ 163.123, 163.130, 163.135, 163.140, aric and palmitic acid esters of sorbitol 163.145, and 163.150 of this chapter, as anhydrides, may be safely used in or on follows: food in accordance with the following (i) It is used alone in an amount not prescribed conditions: to exceed 1 percent of the weight of the (a) The food additive is manufactured finished nonstandardized confectionery by reacting stearic acid (usually con- coating or standardized cacao product. taining associated fatty acids, chiefly (ii) It is used with polysorbate 60 in palmitic) with sorbitol to yield essen- any combination of up to 1 percent sor- tially a mixture of esters. bitan monostearate and up to 0.5 per- (b) The food additive meets the fol- cent polysorbate 60 provided that the lowing specifications: total combination does not exceed 1 Saponification number, 147–157 percent of the weight of the finished
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nonstandardized confectionery coating tions prescribed in paragraph (c) of this or standardized cacao product. section. (4) As an emulsifier in cake icings [42 FR 14491, Mar. 15, 1977, as amended at 43 and cake fillings, with or without one FR 2871, Jan. 20, 1978] or a combination of the following: (i) Polysorbate 65. § 172.844 Calcium stearoyl-2-lactylate. (ii) Polysorbate 60. The food additive calcium stearoyl-2- When used alone, the maximum lactylate may be safely used in or on amount of sorbitan monostearate shall food in accordance with the following prescribed conditions: not exceed 0.7 percent of the weight of (a) The additive, which is a mixture the cake icing or cake filling. When of calcium salts of stearoyl lactylic used with polysorbate 65 and/or poly- acids and minor proportions of other sorbate 60, it shall not exceed 0.7 per- calcium salts of related acids, is manu- cent, nor shall the polysorbate 65 ex- factured by the reaction of stearic acid ceed 0.32 percent or the polysorbate 60 and lactic acid and conversion to the exceed 0.46 percent, and no combina- calcium salts. tion of these emulsifiers shall exceed 1 (b) The additive meets the following percent of the weight of the cake icing specifications: or cake filling. (5) As an emulsifier in solid-state, ed- Acid number, 50–86. ible vegetable fat-water emulsions in- Calcium content, 4.2–5.2 percent. Lactic acid content, 32–38 percent. tended for use as substitutes for milk Ester number, 125–164. or cream in beverage coffee, with or without one or a combination of the (c) It is used or intended for use as following: follows: (i) Polysorbate 60. (1) As a dough conditioner in yeast- leavened bakery products and prepared (ii) Polysorbate 65. mixes for yeast-leavened bakery prod- The maximum amount of the additive ucts in an amount not to exceed 0.5 or additives shall not exceed 0.4 per- part for each 100 parts by weight of cent by weight of the finished edible flour used. vegetable fat-water emulsion. (2) As a whipping agent in: (6) It is used alone as a rehydration (i) Liquid and frozen egg white at a aid in the production of active dry level not to exceed 0.05 percent. yeast in an amount not to exceed 1 per- (ii) Dried egg white at a level not to cent by weight of the dry yeast. exceed 0.5 percent. (7) As an emulsifier, alone or in com- (iii) Whipped vegetable oil topping at bination with polysorbate 60, in the a level not to exceed 0.3 percent of the minimum quantity required to accom- weight of the finished whipped vege- plish the intended effect, in formula- table oil topping. tions of white mineral oil conforming (3) As a conditioning agent in dehy- drated potatoes in an amount not to with § 172.878 and/or petroleum wax exceed 0.5 percent by weight thereof. conforming with § 172.886 for use as pro- (d) To assure safe use of the additive: tective coatings on raw fruits and vege- (1) The label and labeling of the food tables. additive and any intermediate premix (d) To assure safe use of the additive, prepared therefrom shall bear, in addi- in addition to the other information re- tion to the other information required quired by the Act: by the act, the following: (1) The label of the additive and any (i) The name of the additive. intermediate premixes shall bear: (ii) A statement of the concentration (i) The name of the additive. or strength of the additive in any in- (ii) A statement of the concentration termediate premixes. or strength of the additive in any in- (2) The label or labeling of the food termediate premixes. additive shall also bear adequate direc- (2) The label or labeling shall bear tions of use to provide a finished food adequate directions to provide a final that complies with the limitations pre- product that complies with the limita- scribed in paragraph (c) of this section.
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§ 172.846 Sodium stearoyl lactylate. (7) As an emulsifier, stabilizer, or The food additive sodium stearoyl texturizer in sauces or gravies, and the lactylate (CAS Reg. No. 25–383–997) may products containing the same, in an be safely used in food in accordance amount not to exceed 0.25 percent by with the following prescribed condi- weight of the finished food. tions: (8) In prepared mixes for each of the (a) The additive, which is a mixture foods listed in paragraphs (c) (1) of sodium salts of stearoyl lactylic through (7) of this section, provided the acids and minor proportions of sodium additive is used only as specified in salts of related acids, is manufactured each of those paragraphs. by the reaction of stearic acid and lac- (9) As an emulsifier, stabilizer, or tic acid and conversion to the sodium texturizer in cream liqueur drinks, at a salts. level not to exceed 0.5 percent by (b) The additive meets the specifica- weight of the finished product. tions of the ‘‘Food Chemicals Codex,’’ [45 FR 51767, Aug. 5, 1980, as amended at 49 3d Ed. (1981), pp. 300–301, which is incor- FR 10105, Mar. 19, 1984; 50 FR 49536, Dec. 3, porated by reference. Copies may be 1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333, Jan. obtained from the National Academy 27, 1986; 65 FR 60859, Oct. 13, 2000] Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be exam- § 172.848 Lactylic esters of fatty acids. ined at the Office of the Federal Reg- Lactylic esters of fatty acids may be ister, 800 North Capitol Street, NW., safely used in food in accordance with suite 700, Washington, DC 20408. the following prescribed conditions: (c) It is used or intended for use as (a) They are prepared from lactic follows when standards of identity es- acid and fatty acids meeting the re- tablished under section 401 of the Act quirements of § 172.860(b) and/or oleic do not preclude such use: acid derived from tall oil fatty acids (1) As a dough strengthener, emulsi- meeting the requirements of § 172.862. fier, or processing aid in baked prod- (b) They are used as emulsifiers, plas- ucts, pancakes, and waffles, in an ticizers, or surface-active agents in the amount not to exceed 0.5 part for each following foods, when standards of 100 parts by weight of flour used. identity do not preclude their use: (2) As a surface-active agent, emulsi- fier, or stabilizer in icings, fillings, Foods Limitations puddings, and toppings, at a level not Bakery mixes ...... to exceed 0.2 percent by weight of the Baked products ...... finished food. Cake icings, fillings, and toppings (3) As an emulsifier or stabilizer in Dehydrated fruits and vegetables liquid and solid edible fat-water emul- Dehydrated fruit and vegetable sions intended for use as substitutes juices. Edible vegetable fat-water emul- As substitutes for milk or for milk or cream in beverage coffee, at sions. cream in beverage cof- a level not to exceed 0.3 percent by fee. weight of the finished edible fat-water Frozen desserts ...... Liquid shortening ...... For household use. emulsion. Pancake mixes ...... (4) As a formulation aid, processing Precooked instant rice ...... aid, or surface-active agent in dehy- Pudding mixes ...... drated potatoes, in an amount not to exceed 0.5 percent of the dry weight of (c) They are used in an amount not the food. greater than required to produce the (5) As an emulsifier, stabilizer, or intended physical or technical effect, texturizer in snack dips, at a level not and they may be used with shortening to exceed 0.2 percent by weight of the and edible fats and oils when such are finished product. required in the foods identified in para- (6) As an emulsifier, stabilizer, or graph (b) of this section. texturizer in cheese substitutes and 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
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glycol may be safely used in food in ac- acids are used as a cloud inhibitor in cordance with the following prescribed vegetable and salad oils when use is conditions: not precluded by standards of identity. (a) The additive is a mixture of esters The fatty acids used in the production produced by the lactylation of a prod- of the polyglycerol esters meet the re- uct obtained by reacting edible fats or quirements of § 172.860(b), and the oils with propylene glycol. polyglycerol esters are used at a level (b) The additive meets the following not in excess of the amount required to specifications: Water insoluble com- perform its cloud-inhibiting effect. bined lactic acid, 14–18 percent; and Oleic acid derived from tall oil fatty acid number, 12 maximum. acids conforming with § 172.862 may be (c) It is used in amounts not in excess used as a substitute for or together of that reasonably required to produce with the oleic acid permitted by this the intended physical effect as an paragraph. emulsifier, plasticizer, or surface-ac- (d) Polyglycerol esters of butter oil tive agent in food. fatty acids are used as emulsifiers in combination with other approved emul- § 172.852 Glyceryl-lacto esters of fatty sifiers in dry, whipped topping base. acids. The fatty acids used in the production Glyceryl-lacto esters of fatty acids of the polyglycerol esters meet the re- (the lactic acid esters of mono- and quirements of § 172.860(b), and the diglycerides) may be safely used in polyglycerol esters are used at a level food in accordance with the following not in excess of the amount required to prescribed conditions: perform their emulsifying effect. (a) They are manufactured from glyc- erin, lactic acid, and fatty acids con- § 172.856 Propylene glycol mono- and forming with § 172.860 and/or oleic acid diesters of fats and fatty acids. derived from tall oil fatty acids con- Propylene glycol mono- and diesters forming with § 172.862 and/or edible fats of fats and fatty acids may be safely and oils. used in food, subject to the following (b) They are used in amounts not in prescribed conditions: excess of those reasonably required to (a) They are produced from edible accomplish their intended physical or fats and/or fatty acids in compliance technical effect as emulsifiers and plas- with § 172.860 and/or oleic acid derived ticizers in food. from tall oil fatty acids in compliance with § 172.862. § 172.854 Polyglycerol esters of fatty (b) They are used in food in amounts acids. not in excess of that reasonably re- Polyglycerol esters of fatty acids, up quired to produce their intended effect. to and including the decaglycerol esters, may be safely used in food in ac- § 172.858 Propylene glycol alginate. cordance with the following prescribed The food additive propylene glycol conditions: alginate (CAS Reg. No. 9005–37–2) may (a) They are prepared from corn oil, be used as an emulsifier, flavoring ad- cottonseed oil, lard, palm oil from juvant, formulation aid, stabilizer, sur- fruit, peanut oil, safflower oil, sesame factant, or thickener in foods in ac- oil, soybean oil, and tallow and the cordance with the following prescribed fatty acids derived from these sub- conditions: stances (hydrogenated and nonhydro- (a) The additive meets the specifica- genated) meeting the requirements of tions of the Food Chemicals Codex, 3d § 172.860(b) and/or oleic acid derived Ed. (1981), p. 256, which is incorporated from tall oil fatty acids meeting the by reference (copies are available from requirements of § 172.862. the National Academy Press, 2101 Con- (b) They are used as emulsifiers in stitution Ave. NW., Washington, DC food, in amounts not greater than that 20418, or available for inspection at the 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
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up to 85 percent of the carboxylic acid (2) Adequate directions for use. groups esterified with the remaining [47 FR 29950, July 9, 1982] groups either free or neutralized. (b) The additive is used or intended § 172.859 Sucrose fatty acid esters. for use in the following foods as defined Sucrose fatty acid esters identified in in § 170.3(n) of this chapter, when stand- this section may be safely used in ac- ards of identity established under sec- cordance with the following prescribed tion 401 of the act do not preclude such conditions: use: (a) Sucrose fatty acid esters are the (1) As a stabilizer in frozen dairy des- mono-, di-, and tri-esters of sucrose serts, in fruit and water ices, and in with fatty acids and are derived from confections and frostings at a level not sucrose and edible tallow or hydro- to exceed 0.5 percent by weight of the genated edible tallow or edible vege- finished product. table oils. The only solvents which (2) As an emulsifier, flavoring adju- may be used in the preparation of su- vant, stabilizer, or thickener in baked crose fatty acid esters are those gen- goods at a level not to exceed 0.5 per- erally recognized as safe in food or reg- cent by weight of the finished product. ulated for such use by an appropriate (3) As an emulsifier, stabilizer, or section in this part. Ethyl acetate or thickener in cheeses at a level not to methyl ethyl ketone or dimethyl sulf- exceed 0.9 percent by weight of the fin- oxide and isobutyl alcohol (2-methyl-1- ished product. propanol) may be used in the prepara- (4) As an emulsifier, stabilizer, or tion of sucrose fatty acid esters. thickener in fats and oils at a level not (b) Sucrose fatty acid esters meet the to exceed 1.1 percent by weight of the following specifications: finished product. (1) The total content of mono-, di-, (5) As an emulsifier, stabilizer, or and tri-esters is not less than 80 per- thickener in gelatins and puddings at a cent as determined by a method title level not to exceed 0.6 percent by ‘‘Sucrose Fatty Acid Esters, Method of weight of the finished product. Assay,’’ which is incorporated by ref- (6) As a stabilizer or thickener in gra- erence. Copies are available from the vies and in sweet sauces at a level not Center for Food Safety and Applied Nu- to exceed 0.5 percent by weight of the trition (HFS–200), Food and Drug Ad- finished product. ministration, 200 C St. SW., Wash- ington, DC 20204, or available for in- (7) As a stabilizer in jams and jellies spection at the Office of the Federal at a level not to exceed 0.4 percent by Register, 800 North Capitol Street, weight of the finished product. NW., suite 700, Washington, DC 20408. (8) As an emulsifier, stabilizer, or (2) The free sucrose content is not thickener in condiments and relishes more than 5 percent as determined by at a level not to exceed 0.6 percent by Test S.2 in the method titled ‘‘Sucrose weight of the finished product. Fatty Acid Esters, Method of Assay,’’ (9) As a flavoring adjunct or adjuvant which is incorporated by reference. The in seasonings and flavors at a level not availability of this incorporation by to exceed 1.7 percent by weight of the reference is given in paragraph (b)(1) of finished product. this section. (10) As an emulsifier, flavoring adju- (3) The acid value is not more than 6. vant, formulation aid, stabilizer or (4) The residue on ignition (sulfated thickener, or surface active agent in ash) is not more than 2 percent. other foods, where applicable, at a (5) The total ethyl acetate content is level not to exceed 0.3 percent by not more than 350 parts per million as weight of the finished product. determined by a method titled ‘‘Deter- (c) To ensure safe use of the additive, mination of Ethyl Acetate,’’ which is the label of the food additive container incorporated by reference. Copies are shall bear, in addition to the other in- available from the Center for Food formation required by the act: Safety and Applied Nutrition (HFS– (1) The name of the additive, ‘‘pro- 200), Food and Drug Administration, pylene glycol alginate’’ or ‘‘propylene 200 C St. SW., Washington, DC 20204, or glycol ester of alginic acid’’. available for inspection at the Office of
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the Federal Register, 800 North Capitol chapter, in chewing gum as defined in Street, NW., suite 700, Washington, DC § 170.3(n)(6) of this chapter, in coffee 20408. and tea beverages with added dairy in- (6) Arsenic is not more than 3 parts gredients and/or dairy product ana- per million. logues, in confections and frostings as (7) Total heavy metal content (as Pb) defined in § 170.3(n)(9) of this chapter, is not more than 50 parts per million. in dairy product analogues as defined (8) Lead is not more than 10 parts per in § 170.3(n)(10) of this chapter, in frozen million. dairy desserts and mixes as defined in (9) The total content of methyl ethyl § 170.3(n)(20) of this chapter, and in ketone or of methanol shall not be whipped milk products. more than 10 parts per million as deter- (2) As texturizers as defined in mined by a method titled ‘‘Methyl § 170.3(o)(32) of this chapter in biscuit Ethyl Ketone Test; Methyl Alcohol mixes, in chewing gum as defined in Test,’’ which is incorporated by ref- § 170.3(n)(6) of this chapter, in confec- erence. Copies are available from the tions and frostings as defined in Center for Food Safety and Applied Nu- § 170.3(n)(9) of this chapter, and in trition (HFS–200), Food and Drug Ad- surimi-based fabricated seafood prod- ministration, 200 C St. SW., Wash- ucts. ington, DC 20204, or available for in- (3) As components of protective coat- spection at the Office of the Federal ings applied to fresh apples, avocados, Register, 800 North Capitol Street, bananas, banana plantains, limes, mel- NW., suite 700, Washington, DC 20408. ons (honeydew and cantaloupe), pa- (10) The total dimethyl sulfoxide con- paya, peaches, pears, pineapples, and tent is not more than 2 parts per mil- plums to retard ripening and spoiling. lion as determined by a method enti- (d) Sucrose fatty acid esters are used tled ‘‘Determination of Dimethyl Sulf- in accordance with current good manu- oxide,’’ which is incorporated by ref- facturing practice and in an amount erence. Copies are available from the not to exceed that reasonably required Center for Food Safety and Applied Nu- to accomplish the intended effect. trition (HFS–200), Food and Drug Ad- [47 FR 55475, Dec. 10, 1982, as amended at 48 ministration, 200 C St. SW., Wash- FR 38226, Aug. 23, 1983; 52 FR 10883, Apr. 6, ington, DC 20204, or available for in- 1987; 53 FR 22294, 22297, June 15, 1988; 54 FR spection at the Office of the Federal 24897, June 12, 1989; 60 FR 44756, Aug. 29, 1995] Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. § 172.860 Fatty acids. (11) The total isobuytl alcohol (2- The food additive fatty acids may be methyl-1-propanol) content is not more safely used in food and in the manufac- than 10 parts per million as determined ture of food components in accordance by a method entitled ‘‘Determination with the following prescribed condi- of Isobutyl Alcohol,’’ which is incor- tions: porated by reference. Copies are avail- (a) The food additive consists of one able from the Center for Food Safety or any mixture of the following and Applied Nutrition (HFS–200), Food straight-chain monobasic carboxylic and Drug Administration, 200 C St. acids and their associated fatty acids SW., Washington, DC 20204, or available manufactured from fats and oils de- for inspection at the Office of the Fed- rived from edible sources: Capric acid, eral Register, 800 North Capitol Street, caprylic acid, lauric acid, myristic NW., suite 700, Washington, DC 20408. acid, oleic acid, palmitic acid, and ste- (c) Sucrose fatty acid esters may be aric acid. used as follows when standards of iden- (b) The food additive meets the fol- tity established under section 401 of lowing specifications: the Federal Food, Drug, and Cosmetic (1) Unsaponifiable matter does not Act do not preclude such use: exceed 2 percent. (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
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(ii) As evidenced by the absence of (1) In foods as a lubricant, binder, chromatographic peaks with a reten- and as a defoaming agent in accordance tion time relative to aldrin (RA) be- with good manufacturing practice. tween 10 and 25, using the gas (2) As a component in the manufac- chromatographic-electron capture ture of other food-grade additives. method prescribed in paragraph (c)(3) (e) To assure safe use of the additive, of this section. If chromatographic the label and labeling of the additive peaks are found with RA values be- and any premix thereof shall bear, in tween 10 and 25, the food additive shall addition to the other information re- meet the requirements of the bioassay quired by the act, the following: method prescribed in paragraph (c)(2) (1) The common or usual name of the of this section for determining chick- acid or acids contained therein. edema factor. (2) The words ‘‘food grade,’’ in jux- (c) For the purposes of this section: taposition with and equally as promi- (1) Unsaponifiable matter shall be de- termined by the method described in nent as the name of the acid. the 13th Ed. (1980) of the ‘‘Official [42 FR 14491, Mar. 15, 1977, as amended at 47 Methods of Analysis of the Association FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, of Official Analytical Chemists,’’ which 1984; 54 FR 24897, June 12, 1989] is incorporated by reference. Copies are available from the Association of Offi- § 172.861 Cocoa butter substitute from cial Analytical Chemists International, coconut oil, palm kernel oil, or both 481 North Frederick Ave., suite 500, oils. Gaithersburg, MD 20877–2504, or avail- The food additive, cocoa butter sub- able for inspection at the Office of the stitute from coconut oil, palm kernel Federal Register, 800 North Capitol oil, or both oils, may be safely used in Street, NW., suite 700, Washington, DC food in accordance with the following 20408. conditions: (2) Chick-edema factor shall be deter- (a) Cocoa butter substitute from co- mined by the bioassay method de- conut oil, palm kernel oil (CAS Reg. scribed in ‘‘Official Methods of Anal- No. 85665–33–4), or both oils is a mixture ysis of the Association of Official Ana- of triglycerides. It is manufactured by lytical Chemists,’’ 13th Ed. (1980), sec- esterification of glycerol with food- tions 28.127–28.130, which is incor- grade fatty acids (complying with porated by reference. Copies may be § 172.860) derived from edible coconut obtained from the Association of Offi- oil, edible palm kernel oil, or both oils. cial Analytical Chemists International, (b) The ingredient meets the fol- 481 North Frederick Ave., suite 500, lowing specifications: Gaithersburg, MD 20877–2504, or may be examined at the Office of the Federal Acid number: Not to exceed 0.5. Register, 800 North Capitol Street, Saponification number: 220 to 260. NW., suite 700, Washington, DC 20408. Iodine number: Not to exceed 3. (3) The gas chromatographic-electron Melting range: 30 to 44 °C. capture method for testing fatty acids (c) The ingredient is used or intended for chick-edema shall be the method for use as follows: described in the ‘‘Journal of the Asso- ciation of Official Analytical Chem- (1) As coating material for sugar, ists,’’ Volume 50 (No. 1), pages 216–218 table salt, vitamins, citric acid, suc- (1967), or the modified method using a cinic acid, and spices; and sulfuric acid clean-up procedure, as de- (2) In compound coatings, cocoa scribed in the ‘‘Journal of the Associa- creams, cocoa-based sweets, toffees, tion of the Offical Analytical Chem- caramel masses, and chewing sweets as ists,’’ Volume 51 (No. 2), pages 489–490 defined in § 170.3 (n)(9) and (n)(38) of (1968), which are incorporated by ref- this chapter, except that the ingredient erence. See paragraph (c)(2) of this sec- may not be used in a standardized food tion for availability of these ref- unless permitted by the standard of erences. identity. (d) It is used or intended for use as (d) The ingredient is used in accord- follows: ance with current good manufacturing
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practice and in an amount not to ex- addition to the other information re- ceed that reasonably required to ac- quired by the Act, the following: complish the intended effect. (1) The common or usual name of the acid. [56 FR 66970, Dec. 27, 1991; 57 FR 2814, Jan. 23, 1992] (2) The words ‘‘food grade’’ in jux- taposition with and equally as promi- § 172.862 Oleic acid derived from tall nent as the name of the acid. oil fatty acids. [42 FR 14491, Mar. 15, 1977, as amended at 49 The food additive oleic acid derived FR 10105, Mar. 19, 1984] from tall oil fatty acids may be safely used in food and as a component in the § 172.863 Salts of fatty acids. manufacture of food-grade additives in The food additive salts of fatty acids accordance with the following pre- may be safely used in food and in the scribed conditions: manufacture of food components in ac- (a) The additive consists of purified cordance with the following prescribed oleic acid separated from refined tall conditions: oil fatty acids. (a) The additive consists of one or (b) The additive meets the following any mixture of two or more of the alu- specifications: minum, calcium, magnesium, potas- (1) Specifications for oleic acid pre- sium, and sodium salts of the fatty scribed in the ‘‘Food Chemicals acids conforming with § 172.860 and/or Codex.’’ 3d Ed. (1981), pp. 207–208, which oleic acid derived from tall oil fatty is incorporated by reference, except acids conforming with § 172.862. that titer (solidification point) shall (b) The food additive is used or in- not exceed 13.5 °C and unsaponifiable tended for use as a binder, emulsifier, matter shall not exceed 0.5 percent. and anticaking agent in food in accord- Copies of the material incorporated by ance with good manufacturing prac- reference may be obtained from the tice. National Academy Press, 2101 Constitu- (c) To assure safe use of the additive, tion Ave. NW., Washington, DC 20418, the label and labeling of the additive or may be examined at the Office of the and any premix thereof shall bear, in Federal Register, 800 North Capitol addition to the other information re- Street, NW., suite 700, Washington, DC quired by the Act, the following: 20408. (1) The common or usual name of the (2) The resin acid content does not fatty acid salt or salts contained there- exceed 0.01 as determined by ASTM in. method D1240–82, ‘‘Standard Test Meth- (2) The words ‘‘food grade,’’ in jux- od for Rosin Acids in Fatty Acids,’’ taposition with and equally as promi- which is incorporated by reference. nent as the name of the salt. Copies may be obtained from the Amer- ican Society for Testing Materials, 1916 § 172.864 Synthetic fatty alcohols. Race St., Philadelphia, PA 19103, or Synthetic fatty alcohols may be safe- may be examined at the Office of the ly used in food and in the synthesis of Federal Register, 800 North Capitol food components in accordance with Street, NW., suite 700, Washington, DC the following prescribed conditions: 20408. (a) The food additive consists of any (3) The requirements for absence of one of the following fatty alcohols: chick-edema factor as prescribed in (1) Hexyl, octyl, decyl, lauryl, § 172.860. myristyl, cetyl, and stearyl; manufac- (c) It is used or intended for use as tured by fractional distillation of alco- follows: hols obtained by a sequence of oxida- (1) In foods as a lubricant, binder, tion and hydrolysis of organo-alu- and defoaming agent in accordance minums generated by the controlled re- with good manufacturing practice. action of low molecular weight (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:
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(i) Hexyl, octyl, decyl, lauryl, and boiling point range. Copies of the ma- myristyl alcohols contain not less than terial incorporated by reference may 99 percent of total alcohols and not less be obtained from the American Society than 96 percent of straight chain alco- for Testing Materials, 1916 Race St., hols. Any nonalcoholic impurities are Philadelphia, PA 19103, or may be ex- primarily paraffins. amined at the Office of the Federal (ii) Cetyl and stearyl alcohols con- Register, 800 North Capitol Street, tain not less than 98 percent of total NW., suite 700, Washington, DC 20408. alcohols and not less than 94 percent of (3) The analytical method for deter- straight chain alcohols. Any non- mining ultraviolet absorbance limits is alcoholic impurities are primarily as follows: paraffins. (iii) The synthetic fatty alcohols con- GENERAL INSTRUCTIONS tain no more than 0.1 weight percent of All glassware should be scrupulously total diols as determined by a method cleaned to remove all organic matter such as available upon request from the Com- oil, grease, detergent residues, etc. Examine missioner of Food and Drugs. all glassware, including stoppers and stop- (2) Hexyl, octyl, and decyl; manufac- cocks, under ultraviolet light to detect any tured by fractional distillation of alco- residual fluorescent contamination. As a pre- hols obtained by a sequence of oxida- cautionary measure, it is recommended prac- tion, hydrolysis, and catalytic hydro- tice to rinse all glassware with purified iso- genation (catalyst consists of copper, octane immediately before use. No grease is chromium, and nickel) of organo-alu- to be used on stopcocks or joints. Great care to avoid contamination of hydrocarbon sol- minums generated by the controlled re- vent samples in handling and to assure ab- action of low molecular weight sence of any extraneous material arising trialkylaluminum with purified ethyl- from inadequate packaging is essential. Be- ene (minimum 99 percent by volume cause some of the polynuclear hydrocarbons C2H4), and utilizing an external coolant sought in this test are very susceptible to such that these alcohols meet the spec- photo-oxidation, the entire procedure is to ifications prescribed in paragraph (a)(1) be carried out under subdued light. (i) and (iii) of this section. APPARATUS (b) The hydrocarbon solvent used in the process described in paragraph Chromatographic tube. 450 millimeters in length (packing section), inside diameter 19 (a)(1) of this section is a mixture of liq- ± uid hydrocarbons essentially paraffinic millimeters 1 millimeter, equipped with a wad of clean Pyrex brand filtering wool (Cor- in nature, derived from petroleum and ning Glass Works Catalog No. 3950 or equiva- refined to meet the specifications de- lent). The tube shall contain a 250-milliliter scribed in paragraph (b)(1) of this sec- reservoir and a 2-millimeter tetrafluoro- tion when subjected to the procedures ethylene polymer stopcock at the opposite described in paragraph (b) (2) and (3) of end. Overall length of the tube is 670 milli- this section. meters. (1) The hydrocarbon solvent meets Stainless steel rod. 2 feet in length, 2 to 4 the following specifications: millimeters in diameter. ° ° Vacuum oven. Similar to Labline No. 3610 (i) Boiling-point range: 175 C–275 C. but modified as follows: A copper tube one- (ii) Ultraviolet absorbance limits as fourth inch in diameter and 13 inches in follows: length is bent to a right angle at the 4-inch point and plugged at the opposite end; eight Maximum absorb- copper tubes one-eighth inch in diameter and 5 inches in length are silver soldered in Wavelength (millicrons) ance per centimeter drilled holes (one-eighth inch in diameter) to optical path length the one-fourth-inch tube, one on each side at the 5-, 7.5-, 10- and 12.5-inch points; the one- 280–289 ...... 0.15 eighth-inch copper tubes are bent to conform 290–299 ...... 12 with the inner periphery of the oven. 300–359 ...... 05 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.
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Spectrophotometric cells. Fused quartz centimeter path length between 300 and 400 ground glass stoppered cells, optical path mµ. length in the range of 1.000 centimeter ±0.005 Isooctane (2,2,4-trimethylpentane). Use 10 centimeter. With distilled water in the cells, milliliters for the test described in the pre- determine any absorbance difference. ceding paragraph. If necessary, isooctane Spectrophotometer. Spectral range 250 milli- may be purified by passage through a column microns—400 millimicrons with spectral slit of activated silica gel (Grade 12, Davison width of 2 millimicrons or less: under instru- Chemical Co., Baltimore, Md., or equiva- ment operating conditions for these absorb- lent). ance measurements, the spectrophotometer Benzene, spectro grade (Burdick and Jackson shall also meet the following performance Laboratories, Inc., Muskegon, Mich., or equiva- requirements: lent). Use 80 milliliters for the test. If nec- Absorbance repeatability, ±0.01 at 0.4 ab- essary, benzene may be purified by distilla- sorbance. tion or otherwise. Absorbance accuracy,1 ±0.05 at 0.4 absorb- Hexane, spectro grade (Burdick and Jackson ance. Laboratories, Inc., Muskegon, Mich., or equiva- Wavelength repeatability, ±0.2 milli- lent). Use 650 milliliters for the test. If nec- essary, hexane may be purified by distilla- micron. tion or otherwise. Wavelength accuracy, ±1.0 millimicron. 1,2-Dichloroethane, spectro grade (Matheson, Nitrogen cylinder. Water-pumped or equiva- Coleman, and Bell, East Rutherford, N.J., or lent purity nitrogen in cylinder equipped equivalent). Use 20 milliliters for test. If nec- with regulator and valve to control flow at 5 essary, 1,2-dichloroethane may be purified by p.s.i.g. distillation. Eluting mixtures: REAGENTS AND MATERIALS 1. 10 percent 1,2-dichloroethane in hexane. Organic solvents. All solvents used through- Pipet 100 milliliters of 1,2-dichloroethane out the procedure shall meet the specifica- into a 1-liter glass-stoppered volumetric tions and tests described in this specifica- flask and adjust to volume with hexane, with tion. The isooctane, benzene, hexane, and 1,2- mixing. dichloroethane designated in the list fol- 2. 40 percent benzene in hexane. Pipet 400 lowing this paragraph shall pass the fol- milliliters of benzene into a 1-liter glass- lowing test: stoppered volumetric flask and adjust to vol- To the specified quantity of solvent in a ume with hexane, with mixing. 250-milliliter beaker, add 1 milliliter of puri- n-Hexadecane, 99 percent olefin-free. Dilute fied n-hexadecane and evaporate in the vacu- 1.0 milliliter of n-hexadecane to 5 milliliters um oven under a stream of nitrogen. Dis- with isooctane and determine the absorbance continue evaporation when not over 1 milli- in a 1-centimeter cell compared to isooctane liter of residue remains. (To the residue from as reference between 280 mµ-400mµ. The ab- benzene add a 5-milliliter portion of purified sorbance per centimeter path length shall isooctane, reevaporate, and repeat once to not exceed 0.00 in this range. If necessary, n- insure complete removal of benzene.) hexadecane may be purified by percolation Dissolve the 1 milliliter of hexadecane res- through activated silica gel or by distilla- idue in isooctane and make to 5 milliliters tion. volume. Determine the absorbance in the 1- Silica gel, 28–200 mesh (Grade 12, Davison centimeter path length cells compared to Chemical Co., Baltimore, Md., or equivalent). isooctane as reference. The absorbance of the Activate as follows: Weigh about 900 grams into a 1-gallon bottle, add 100 milliliters of solution of the solvent residue shall not ex- de-ionized water, seal the bottle and shake ceed 0.02 per centimeter path length between and roll at intervals for 1 hour. Allow to 280 and 300 mµ and shall not exceed 0.01 per equilibrate overnight in the sealed bottle. Activate the gel at 150 °C for 16 hours, in a 1 As determined by using potassium chro- 2-inch × 7-inch × 12-inch porcelain pan loose- mate for reference standard and described in ly covered with aluminum foil, cool in a National Bureau of Standards Circular 484, dessicator, transfer to a bottle and seal. Spectrophotometry, U.S. Department of Commerce, (1949). The accuracy is to be de- PROCEDURE termined by comparison with the standard Determination of ultraviolet absorbance. Be- values at 290, 345, and 400 millimicrons. Cir- fore proceeding with the analysis of a sample cular 484 is incorporated by reference. Copies determine the absorbance in a 1-centimeter are available from the Center for Food Safe- path cell for the reagent blank by carrying ty and Applied Nutrition (HFS–200), Food out the procedure without a sample. Record and Drug Administration, 200 C St. SW., the absorbance in the wavelength range of Washington, DC 20204, or available for in- 280 to 400 millimicrons. Typical reagent spection at the Office of the Federal Reg- blank absorbance in this range should not ister, 800 North Capitol Street, NW., suite exceed 0.04 in the 280 to 299 millimicron 700, Washington, DC 20408. range, 0.02 in the 300 to 359 millimicron
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range, and 0.01 in the 360 to 400 millimicron sorbance derived from reagents as deter- range. If the characteristic benzene peaks in mined by carrying out the procedure without the 250 to 260 millimicron region are present, a sample. If the corrected absorbance does remove the benzene by the procedure de- not exceed the limits prescribed in para- scribed above under ‘‘Reagents and Mate- graph (b)(1)(ii) of this section, the sample rials,’’ ‘‘Organic Solvents,’’ and record ab- meets the ultraviolet absorbance specifica- sorbance again. tions for hydrocarbon solvent. Transfer 50 grams of silica gel to the chromatographic tube for sample analysis. (c) Synthetic fatty alcohols may be Raise and drop the column on a semisoft, used as follows: clean surface for about 1 minute to settle the (1) As substitutes for the cor- gel. Pour 100 milliliters of hexane into the responding naturally derived fatty al- column with the stopcock open and allow to cohols permitted in food by existing drain to about one-half inch above the gel. regulations in this part or part 173 of Turn off the stopcock and allow the column to cool for 30 minutes. After cooling, vibrate this chapter provided that the use is in the column to eliminate air and stir the top compliance with any prescribed limita- 1 to 2 inches with a small diameter stainless tions. steel rod. Take care not to get the gel above (2) As substitutes for the cor- the liquid and onto the sides of the column. responding naturally derived fatty al- Weigh out 40 grams ±0.1 gram of the hydro- cohols used as intermediates in the carbon solvent sample into a 250-milliliter synthesis of food additives and other beaker, add 50 milliliters of hexane, and pour the solution into the column. Rinse the substances permitted in food. beaker with 50 milliliters of hexane and add [42 FR 14491, Mar. 15, 1977, as amended at 47 this to the column. Allow the hexane sample FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, solution to elute into a 500-milliliter beaker 1984; 54 FR 24897, June 12, 1989] until the solution is about one-half inch above the gel. Rinse the column three times § 172.866 Synthetic glycerin produced with 50-milliliter portions of hexane. Allow by the hydrogenolysis of carbo- each hexane rinse to separately elute to hydrates. about one-half inch above the gel. Replace the eluate beaker (discard the hexane eluate) Synthetic glycerin produced by the with a 250-milliliter beaker. Add two sepa- hydrogenolysis of carbohydrates may rate 25-milliliter portions of 10 percent 1,2- be safely used in food, subject to the dichloroethane and allow each to separately provisions of this section: elute as before. Finally, add 150 milliliters of (a) It shall contain not in excess of 10 percent 1,2-dichloroethane for a total of 200 milliliters. When the final 10 percent 1,2- 0.2 percent by weight of a mixture of dichloroethane fraction is about one-half butanetriols. inch above the top of the gel bed, replace the (b) It is used or intended for use in an receiving beaker (discard the 1,2- amount not to exceed that reasonably dichloroethane eluate) with a 250-milliliter required to produce its intended effect. beaker containing 1 milliliter of hexadecane. Adjust the elution rate to 2 to 3 milliliters § 172.867 Olestra. per minute, add two 25-milliliter portions of 40 percent benzene and allow each to sepa- Olestra, as identified in this section, rately elute as before to within about one- may be safely used in accordance with half inch of the gel bed. Finally, add 150 mil- the following conditions: liliters of 40 percent benzene for a total of 200 (a) Olestra is a mixture of octa-, milliliters. Evaporate the benzene in the hepta-, and hexa-esters of sucrose with oven with vacuum and sufficient nitrogen fatty acids derived from edible fats and 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- termined by a constant volume of hexa- erally recognized as safe or approved decane) add 5 milliliters of isooctane and for use as food ingredients. The chain 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 , and hexa-esters is not less than 97 per- dilute to volume with isooctane. Determine 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
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by reference in accordance with 5 eral Register, 800 North Capitol Street, U.S.C. 552(a) and 1 CFR part 51. Copies NW., suite 700, Washington, DC. are available from the Office of Pre- (6) The content of C12 and C14 fatty market Approval, Center for Food acids is each not more than 1 percent, Safety and Applied Nutrition (HFS– and total C20 and longer fatty acids is 200), Food and Drug Administration, not more than 20 percent. C16 and C18 200 C St. SW., Washington, DC, or may fatty acids make up the remainder be examined at the Center for Food with total content not less than 78 per- Safety and Applied Nutrition’s Li- cent as determined by the method list- brary, 200 C St. SW., rm. 3321, Wash- ed in paragraph (b)(5) of this section. ington, DC, or at the Office of the Fed- (7) The free fatty acid content is not eral Register, 800 North Capitol Street, more than 0.5 percent as determined by NW., suite 700, Washington, DC. a method entitled ‘‘Free Fatty Acids’’ (2) The content of octa-ester is not published in the Official Methods and less than 70 percent as determined by a Recommended Practices of the American method entitled ‘‘Measurement of the Oil Chemists’ Society, 3d Ed. (1985) vol. 1, Relative Ester Distribution of Olestra which is incorporated by reference in Test Material’’ dated December 19, accordance with 5 U.S.C. 552(a) and 1 1995, which is incorporated by reference CFR part 51. Copies are available from in accordance with 5 U.S.C. 552(a) and 1 the American Oil Chemists Society, CFR part 51. Copies are available from 1608 Broadmoor Dr., Champaign, IL the Office of Premarket Approval, Cen- 61821, or may be examined at the Cen- ter for Food Safety and Applied Nutri- ter for Food Safety and Applied Nutri- tion (HFS–200), Food and Drug Admin- tion’s Library, 200 C St. SW., rm. 3321, istration, 200 C St. SW., Washington, Washington, DC, or at the Office of the DC, or may be examined at the Center Federal Register, 800 North Capitol for Food Safety and Applied Nutri- Street, NW., suite 700, Washington, DC. tion’s Library, 200 C St. SW., rm. 3321, (8) The residue on ignition (sulfated Washington, DC, or at the Office of the ash) is not more than 0.5 percent. Federal Register, 800 North Capitol (9) Total methanol content is not Street, NW., suite 700, Washington, DC. more than 300 parts per million as de- (3) The content of hexa-ester is not termined by the ‘‘Total Available more than 1 percent as determined by Methanol Method,’’ dated December 19, the method listed in paragraph (b)(2) of 1995, which is incorporated by reference this section. in accordance with 5 U.S.C. 552(a) and 1 (4) The content of penta-ester is not CFR part 51. Copies are available from more than 0.5 percent as determined by the Office of Premarket Approval, Cen- the method listed in paragraph (b)(2) of ter for Food Safety and Applied Nutri- this section. tion (HFS–200), Food and Drug Admin- (5) The unsaturated fatty acid con- istration, 200 C St. SW., Washington, tent is not less than 25 percent (thus DC or may be examined at the Center not more than 75 percent saturated for Food Safety and Applied Nutri- fatty acid) and not more than 83 per- tion’s Library, 200 C St. SW., rm. 3321, cent as determined by a method enti- Washington, DC, or at the Office of the tled ‘‘Measurement of the Fatty Acid Federal Register, 800 North Capitol Composition of Olestra Test Material,’’ Street, NW., suite 700, Washington, DC. dated December 19, 1995, which is incor- (10) The total heavy metal content porated by reference in accordance (as Pb) is not more than 10 parts per with 5 U.S.C. 552(a) and 1 CFR part 51. million. Copies are available from the Office of (11) Lead is not more than 0.1 part Premarket Approval, Center for Food per million, as determined by a method Safety and Applied Nutrition (HFS– entitled ‘‘Atomic Absorption 200), Food and Drug Administration, Spectrophotometric Graphite Furnace 200 C St. SW., Washington, DC, or may Method,’’ Food Chemicals Codex, 3d Ed. be examined at the Center for Food 3d Supp. p. 168 (1992), which is incor- Safety and Applied Nutrition’s Li- porated by reference in accordance brary, 200 C St. SW., rm. 3321, Wash- with 5 U.S.C. 552(a) and 1 CFR part 51. ington, DC, or at the Office of the Fed- Copies are available from the National
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Research Council Press, 2101 Constitu- eral Register, 800 North Capitol St. tion Ave. NW., Washington, DC, or may NW., suite 700, Washington, DC. be examined at the Center for Food (c) Olestra may be used in place of Safety and Applied Nutrition’s Li- fats and oils in prepackaged ready-to- brary, 200 C St. SW., rm. 3321, Wash- eat savory (i.e., salty or piquant but ington, DC, or at the Office of the Fed- not sweet) snacks. In such foods, the eral Register, 800 North Capitol Street, additive may be used in place of fats NW., suite 700, Washington, DC. and oils for frying or baking, in dough (12) Water is not more than 0.1 per- conditioners, in sprays, in filling ingre- cent, as determined by a method enti- dients, or in flavors. tled ‘‘Moisture,’’ Official Methods and (d) To compensate for any inter- Recommended Practices of the American ference with absorption of fat soluble Oil Chemists’ Society, 4th Ed. (1989), vol. vitamins, the following vitamins shall 1, which is incorporated by reference in be added to foods containing olestra: accordance with 5 U.S.C. 552(a) and 1 1.9 milligrams alpha-tocopherol equiva- CFR part 51. Copies are available from lents per gram olestra; 51 retinol the American Oil Chemists Society, equivalents per gram olestra (as 1608 Broadmoor Dr., Champaign, IL retinyl acetate or retinyl palmitate); 12 61821, or may be examined at the Cen- IU vitamin D per gram olestra; and 8 µg ter for Food Safety and Applied Nutri- vitamin K per gram olestra. tion’s Library, 200 C St. SW., rm. 3321, 1 (e)(1) The label of a food containing Washington, DC, or at the Office of the olestra shall bear the following state- Federal Register, 800 North Capitol ment in the manner prescribed in para- Street, NW., suite 700, Washington, DC. graph (e)(2) of this section: (13) Peroxide value is not more than 10 meq/kg as determined by a method THIS PRODUCT CONTAINS OLESTRA. Olestra entitled ‘‘Peroxide Value,’’ Official may cause abdominal cramping and loose Methods and Recommended Practices of stools. Olestra inhibits the absorption of the American Oil Chemists’ Society, 4th some vitamins and other nutrients. Vitamins Ed. (1989) vol. 1, which is incorporated A, D, E, and K have been added. by reference in accordance with 5 (2) The statement required by para- U.S.C. 552(a) and 1 CFR part 51. Copies graph (e)(1) of this section shall: are available from the American Oil (i) Appear either on the principal dis- Chemists Society, 1608 Broadmoor Dr., play panel or on the information panel Champaign, IL 61821, or may be exam- of the label; ined at the Center for Food Safety and (ii) Be enclosed by a 0.5 point box Applied Nutrition’s Library, 200 C St. rule with 2.5 points of space around the SW., rm. 3321, Washington, DC, or at statement. the Office of the Federal Register, 800 (iii) Utilize at least one point lead- North Capitol Street, NW., suite 700, ing; Washington, DC. (14) The stiffness is not less than 50 (iv) Have type that is kerned so the kiloPascals/second, as determined by a letters do not touch; method entitled ‘‘Method for Measure- (v) Be all black or one color type, ment of the Stiffness of Olestra,’’ dated printed on a white or other neutral December 19, 1995, which is incor- contrasting background whenever pos- porated by reference in accordance sible; with 5 U.S.C. 552(a) and 1 CFR part 51. (vi) Utilize a single easy-to-read type Copies are available from the Office of style such as Helvetica Regular and Premarket Approval, Center for Food upper and lower case letters; and Safety and Applied Nutrition (HFS– (vii) Be in type size no smaller than 200), Food and Drug Administration, 8 point. 200 C St. SW., Washington, DC, or may (3) The sentence ‘‘This Product Con- be examined at the Center for Food tains Olestra.’’ shall be highlighted by Safety and Applied Nutrition’s Li- bold or extra bold type, such as brary, 200 C St. SW., rm. 3321, Wash- Helvetica Black. The label shall appear ington, DC, or at the Office of the Fed- as follows:
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(4) Vitamins A, D, E, and K present in (a) The food additive is a cellulose foods as a result of the requirement in ether containing ethoxy (OC2H5) groups paragraph (d) of this section shall be attached by an ether linkage and con- declared in the listing of ingredients. taining on an anhydrous basis not more Such vitamins shall not be considered than 2.6 ethoxy groups per in determining nutrient content for the anhydroglucose unit. nutritional label or for any nutrient (b) It is used or intended for use as claims, express or implied. follows: (5) Olestra shall not be considered as (1) As a binder and filler in dry vita- a source of fat or calories for purposes min preparations. of §§ 101.9 and 101.13 of this chapter. (2) As a component of protective (f) Consistent with its obligation to coatings for vitamin and mineral tab- monitor the safety of all additives in lets. the food supply, including olestra, the (3) As a fixative in flavoring com- Food and Drug Administration will re- pounds. view and evaluate all data and infor- mation bearing on the safety of olestra § 172.870 Hydroxypropyl cellulose. received by the agency after the effec- The food additive hydroxypropyl cel- tive date of this regulation, and will lulose may be safely used in food, ex- present such data, information, and cept standardized foods that do not evaluation to the agency’s Food Advi- provide for such use, in accordance sory Committee within 30 months of with the following prescribed condi- the effective date of this regulation. tions: The purpose of such presentation will (a) The additive consists of one of the be to receive advice from the Com- following: mittee on whether there continues to (1) A cellulose ether containing pro- be reasonable certainty that use of pylene glycol groups attached by an olestra in compliance with this regula- ether linkage which contains, on an an- tion is not harmful. The agency will hydrous basis, not more than 4.6 hold such additional Food Advisory hydroxypropyl groups per Committee meetings on olestra as the anhydroglucose unit. The additive has agency determines, in its discretion, to a minimum viscosity of 145 centipoises be necessary. Based upon the results of for 10 percent by weight aqueous solu- this entire process, the FDA will ini- tion at 25 °C. tiate any appropriate regulatory pro- (2) A cellulose ether containing pro- ceedings. pylene glycol groups attached by an [61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, ether linkage having a hydroxypropoxy 1996] (OC3H6OH) content of 5 to 16 percent weight in weight (w/w) on an anhydrous § 172.868 Ethyl cellulose. basis, i.e., 0.1 to 0.4 hydroxypropyl The food additive ethyl cellulose may groups per anhydroglucose unit. The be safely used in food in accordance common name for this form of the ad- with the following prescribed condi- ditive is low substituted hydroxypropyl tions: cellulose.
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(b) The additive is used or intended (a) The additive complies with the for use as follows: definition and specifications prescribed (1) The additive identified in para- in the National Formulary, 12th edi- graph (a)(1) of this section is used or tion. intended for use as an emulsifier, film (b) It is used or intended for use as an former, protective colloid, stabilizer, emulsifier, film former, protective col- suspending agent, or thickener, in ac- loid, stabilizer, suspending agent, or cordance with good manufacturing thickener, in accordance with good practice. manufacturing practice. (2) The additive identified in para- (c) To insure safe use of the additive, graph (a)(2) of this section is used or the container of the additive, in addi- intended for use as a binder and dis- tion to being labeled as required by the integrator in tablets or wafers con- general provisions of the act, shall be taining dietary supplements of vita- accompanied by labeling which con- mins and/or minerals. The additive is tains adequate directions for use to used in accordance with good manufac- provide a final product that complies turing practice. with the limitations prescribed in para- [46 FR 50065, Oct. 9, 1981] graph (b) of this section. [42 FR 14491, Mar. 15, 1977, as amended at 47 § 172.872 Methyl ethyl cellulose. FR 38273, Aug. 31, 1982] The food additive methyl ethyl cel- lulose may be safely used in food in ac- § 172.876 Castor oil. cordance with the following prescribed The food additive castor oil may be conditions. safely used in accordance with the fol- (a) The additive is a cellulose ether lowing conditions: having the general formula [C6H(10–x– (a) The additive meets the specifica- y)O5(CH3)x(C2H5)y]n, where x is the num- tions of the United States Pharma- ber of methyl groups and y is the num- copeia XX (1980). ber of ethyl groups. The average value (b) The additive is used or intended of x is 0.3 and the average value of y is for use as follows: 0.7. (b) The additive meets the following Use and Limitations specifications: Hard candy production—As a release agent (1) The methoxy content shall be not and antisticking agent, not to exceed 500 less than 3.5 percent and not more than parts per million in hard candy. Vitamin and mineral tablets—As a compo- 6.5 percent, calculated as OCH3, and the ethoxy content shall be not less than nent of protective coatings. 14.5 percent and not more than 19 per- [42 FR 14491, Mar. 15, 1977, as amended at 49 cent, calculated as OC2H5, both meas- FR 10105, Mar. 19, 1984] ured on the dry sample. (2) The viscosity of an aqueous solu- § 172.878 White mineral oil. tion, 2.5 grams of the material in 100 White mineral oil may be safely used milliliters of water, at 20 °C, is 20 to 60 in food in accordance with the fol- centipoises. lowing conditions: (3) The ash content on a dry basis has (a) White mineral oil is a mixture of a maximum of 0.6 percent. liquid hydrocarbons, essentially par- (c) The food additive is used as an affinic and naphthenic in nature ob- aerating, emulsifying, and foaming tained from petroleum. It is refined to agent, in an amount not in excess of meet the following specifications: that reasonably required to produce its (1) It meets the test requirements of intended effect. the United States Pharmacopeia XX (1980) for readily carbonizable sub- § 172.874 Hydroxypropyl stances (page 532). methylcellulose. (2) It meets the test requirements of The food additive hydroxypropyl U.S.P. XVII for sulfur compounds (page methylcellulose (CAS Reg. No. 9004–65– 400). 3) may be safely used in food, except in (3) It meets the specifications pre- standardized foods which do not pro- scribed in the ‘‘Journal of the Associa- vide for such use if: tion of Official Analytical Chemists,’’
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Volume 45, page 66 (1962), which is in- Register, 800 North Capitol Street, corporated by reference, after correc- NW., suite 700, Washington, DC 20408. tion of the ultraviolet absorbance for (b) White mineral oil may contain any absorbance due to added anti- any antioxidant permitted in food by oxidants. Copies of the material incor- regulations issued in accordance with porated by reference are available from section 409 of the Act, in an amount the Center for Food Safety and Applied not greater than that required to Nutrition (HFS–200), Food and Drug produce its intended effect. Administration, 200 C St. SW., Wash- (c) White mineral oil is used or in- ington, DC 20204, or available for in- spection at the Office of the Federal 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 chap- ter. 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 manu- facturing 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 manu- facturing 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. 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:
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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 prac- tice. In beet sugar and yeast; as defoaming agent ...... As prescribed in § 173.340 of this chapter.
(d) Petrolatum may contain any SW., Washington, DC 20204, or available for antioxidant permitted in food by regu- inspection at the Office of the Federal Reg- lations issued in accordance with sec- ister, 800 North Capitol Street, NW., suite tion 409 of the Act, in an amount not 700, Washington, DC 20408. For hydrocarbons boiling below 250 °F, the nonvolatile residue greater than that required to produce shall be determined by ASTM method D1353– its intended effect. 78, ‘‘Standard Test Method for Nonvolatile [42 FR 14491, Mar. 15, 1977, as amended at 49 Matter in Volatile Solvents for Use in Paint, FR 10105, Mar. 19, 1984] Varnish, Lacquer, and Related Products;’’ for those boiling above 121 °C, ASTM method § 172.882 Synthetic isoparaffinic petro- D381–80, ‘‘Standard Test Method for Existent leum hydrocarbons. Gum in Fuels by Jet Evaporation’’ shall be used. These methods are incorporated by ref- Synthetic isoparaffinic petroleum erence. Copies may be obtained from the hydrocarbons may be safely used in American Society for Testing Materials, 1916 food, in accordance with the following Race St., Philadelphia, PA 19103, or may be conditions: examined at the Office of the Federal Reg- (a) They are produced by synthesis ister, 800 North Capitol Street, NW., suite from petroleum gases and consist of a 700, Washington, DC 20408. mixture of liquid hydrocarbons meet- (b) Isoparaffinic petroleum hydro- ing the following specifications: carbons may contain antioxidants au- Boiling point 93–260 °C as determined by thorized for use in food in an amount ASTM method D86–82, ‘‘Standard Method for not to exceed that reasonably required Distillation of Petroleum Products,’’ which to accomplish the intended technical is incorporated by reference. Copies may be effect nor to exceed any prescribed lim- obtained from the American Society for itations. Testing Materials, 1916 Race St., Philadel- (c) Synthetic isoparaffinic petroleum phia, PA 19103, or may be examined at the hydrocarbons are used or intended for Office of the Federal Register, 800 North Cap- itol Street, NW., suite 700, Washington, DC use as follows: 20408. Uses Limitations Ultraviolet absorbance: 260–319 millimicrons—1.5 maximum. 1. In the froth-flotation cleaning of In an amount not to ex- 320–329 millimicrons—0.08 maximum. vegetables. ceed good manufac- 330–350 millimicrons—0.05 maximum. turing practice. Nonvolatile residual: 0.002 gram per 100 2. As a component of insecticide Do. milliliters maximum. formulations for use on proc- Synthetic isoparaffinic petroleum hydro- essed foods. carbons containing antioxidants shall meet 3. As a component of coatings on Do. fruits and vegetables. the specified ultraviolet absorbance limits 4. As a coating on shell eggs ...... Do. after correction for any absorbance due to 5. As a float on fermentation Do. the antioxidants. The ultraviolet absorbance fluids in the manufacture of vin- shall be determined by the procedure de- egar and wine and on brine scribed for application of mineral oil, dis- used in curing pickles, to pre- regarding the last sentence of the procedure, vent or retard access of air, under ‘‘Specifications’’ on page 66 of the evaporation, and contamination ‘‘Journal of the Association of Official Ana- with wild organisms during fer- mentation. lytical Chemists,’’ Volume 45 (February 1962), which is incorporated by reference. Copies are available from the Center for [42 FR 14491, Mar. 15, 1977, as amended at 47 Food Safety and Applied Nutrition (HFS– FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, 200), Food and Drug Administration, 200 C St. 1984; 54 FR 24897, June 12, 1989]
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§ 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. (a) The additive is a mixture of liquid Maximum hydrocarbons derived from petroleum ultraviolet absorb- or synthesized from petroleum gases. ance per The additive is chiefly paraffinic, centimeter isoparaffinic, or naphthenic in nature. path length (b) The additive meets the following 280–289 millimicrons ...... 0.15 specifications: 290–299 millimicrons ...... 0.12 300–359 millimicrons ...... 0.08 (1) Odor is faint and not kerosenic. 360–400 millimicrons ...... 0.02 (2) Initial boiling point is 300 °F min- imum. ANALYTICAL SPECIFICATION FOR PETROLEUM (3) Final boiling point is 650 °F max- WAX imum. GENERAL INSTRUCTIONS (4) Ultraviolet absorbance limits de- termined by method specified in Because of the sensitivity of the test, the § 178.3620(b)(1)(ii) of this chapter, as fol- possibility of errors arising from contamina- lows: tion is great. It is of the greatest importance that all glassware be scrupulously cleaned to Maximum remove all organic matter such as oil, absorb- grease, detergent residues, etc. Examine all µ ance per glassware, including stoppers and stopcocks, Wavelength m centimeter optical under ultraviolet light to detect any residual pathlength fluorescent contamination. As a pre- cautionary measure it is recommended prac- 280–289 ...... 4.0 tice to rinse all glassware with purified iso- 290–299 ...... 3.3 octane immediately before use. No grease is 300–329 ...... 2.3 to be used on stopcocks or joints. Great care 330–360 ...... 8 to avoid contamination of wax samples in handling and to assure absence of any extra- (c) The additive is used as follows: neous material arising from inadequate packaging is essential. Because some of the Use Limitations polynuclear hydrocarbons sought in this test As a coating on shell eggs ...... In an amount not to ex- are very susceptible to photo-oxidation, the ceed good manufac- entire procedure is to be carried out under turing practice. subdued light. As a defoamer in processing beet Complying with sugar and yeast. § 173.340 of this chap- APPARATUS ter. Separatory funnels. 250–milliliter, 500–milli- As a float on fermentation fluids in In an amount not to ex- the manufacture of vinegar and ceed good manufac- liter, 1,000–milliliter, and preferably 2,000– wine to prevent or retard ac- turing practice. milliliter capacity, equipped with tetra- cess of air, evaporation, and fluoroethylene polymer stopcocks. wild yeast contamination during Reservoir. 500–milliliter capacity, equipped fermentation. with a 24/40 standard taper male fitting at In the froth-flotation cleaning of Do. the bottom and a suitable ball-joint at the vegetables. top for connecting to the nitrogen supply. As a component of insecticide for- Do. The male fitting should be equipped with mulations used in compliance with regulations issued in parts glass hooks. 170 through 189 of this chapter. Chromatographic tube. 180 millimeters in length, inside diameter to be 15.7 millimeters ±0.1 millimeter, equipped with a coarse, frit- § 172.886 Petroleum wax. ted-glass disc, a tetrafluoroethylene polymer Petroleum wax may be safely used in stopcock, and a female 24/40 standard tapered or on food, in accordance with the fol- fitting at the opposite end. (Overall length of lowing conditions: the column with the female joint is 235 milli- meters.) The female fitting should be (a) Petroleum wax is a mixture of equipped with glass hooks. solid hydrocarbons, paraffinic in na- Disc. Tetrafluoroethylene polymer 2–inch ture, derived from petroleum, and re- diameter disc approximately 3⁄16–inch thick
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with a hole bored in the center to closely fit REAGENTS AND MATERIALS the stem of the chromatographic tube. Heating jacket. Conical, for 500–milliliter Organic solvents. All solvents used through- separatory funnel. (Used with variable trans- out the procedure shall meet the specifica- former heat control.) tions and tests described in this specifica- Suction flask. 250–milliliter or 500–milliliter tion. The isooctane, benzene, acetone, and filter flask. methyl alcohol designated in the list fol- Condenser. 24/40 joints, fitted with a drying lowing this paragraph shall pass the fol- tube, length optional. lowing test: Evaporation flask (optional). 250–milliliter To the specified quantity of solvent in a or 500–milliliter capacity all-glass flask 250–milliliter Erlenmeyer flask, add 1 milli- equipped with standard taper stopper having liter of purified n-hexadecane and evaporate inlet and outlet tubes to permit passage of on the steam bath under a stream of nitro- nitrogen across the surface of contained liq- gen (a) loose aluminum foil jacket around uid to be evaporated. the flask will speed evaporation). Dis- Vacuum distillation assembly. All glass (for continue evaporation when not over 1 milli- purification of dimethyl sulfoxide); 2–liter liter of residue remains. (To the residue from distillation flask with heating mantle; benzene add a 10–milliliter portion of puri- Vigreaux vacuum-jacketed condenser (or fied isooctane, reevaporate, and repeat once equivalent) about 45 centimeters in length to insure complete removal of benzene.) and distilling head with separable cold finger Alternatively, the evaporation time can be condenser. Use of tetrafluoroethylene poly- reduced by using the optional evaporation mer sleeves on the glass joints will prevent flask. In this case the solvent and n-hexa- freezing. Do not use grease on stopcocks or decane are placed in the flask on the steam joints. bath, the tube assembly is inserted, and a Spectrophotometric cells. Fused quartz cells, stream of nitrogen is fed through the inlet optical path length in the range of 5.000 cen- tube while the outlet tube is connected to a timeters ±0.005 centimeter; also for checking solvent trap and vacuum line in such a way spectrophotometer performance only, optical as to prevent any flow-back of condensate path length in the range 1.000 centimeter into the flask. ±0.005 centimeter. With distilled water in the Dissolve the 1 milliliter of hexadecane res- cells, determine any absorbance differences. idue in isooctane and make to 25 milliliters Spectrophotometer. Spectral range 250 milli- volume. Determine the absorbance in the 5– microns–400 millimicrons with spectral slit centimeter path length cells compared to width of 2 millimicrons or less, under instru- isooctane as reference. The absorbance of the ment operating conditions for these absorb- solution of the solvent residue (except for ance measurements, the spectrophotometer methyl alcohol) shall not exceed 0.01 per cen- shall also meet the following performance timeter path length between 280 and 400 mµ. requirements: For methyl alcohol this absorbance value Absorbance repeatability, ±0.01 at 0.4 ab- shall be 0.00. sorbance. Isooctane (2,2,4–trimethylpentane). Use 180 Absorbance accuracy, 1 ±0.05 at 0.4 absorb- milliliters for the test described in the pre- ance. ceding paragraph. Purify, if necessary, by Wavelength repeatability, ±0.2 milli- passage through a column of activated silica micron. gel (Grade 12, Davison Chemical Company, Wavelength accuracy, ±1.0 millimicron. Baltimore, Maryland, or equivalent) about 90 Nitrogen cylinder. Water-pumped or equiva- centimeters in length and 5 centimeters to 8 lent purity nitrogen in cylinder equipped centimeters in diameter. with regulator and valve to control flow at 5 Benzene, A.C.S. reagent grade. Use 150 milli- p.s.i.g. liters for the test. Purify, if necessary, by distillation or otherwise. 1 As determined by using potassium chro- Acetone, A.C.S. reagent grade. Use 200 milli- mate for reference standard and described in liters for the test. Purify, if necessary, by National Bureau of Standards Circular 484, distillation. Spectrophotometry, U.S. Department of Eluting mixtures: Commerce, (1949). The accuracy is to be de- 1. 10 percent benzene in isooctane. Pipet 50 termined by comparison with the standard milliliters of benzene into a 500–milliliter values at 290, 345, and 400 millimicrons. Cir- glass-stoppered volumetric flask and adjust cular 484 is incorporated by reference. Copies to volume with isooctane, with mixing. are available from the Center for Food Safe- 2. 20 percent benzene in isooctane. Pipet 50 ty and Applied Nutrition (HFS–200), Food milliliters of benzene into a 250–milliliter and Drug Administration, 200 C St. SW., glass-stoppered volumetric flask, and adjust Washington, DC 20204, or available for in- to volume with isooctane, with mixing. spection at the Office of the Federal Reg- 3. Acetone-benzene-water mixture. Add 20 ister, 800 North Capitol Street, NW., suite milliliters of water to 380 milliliters of ace- 700, Washington, DC 20408. tone and 200 milliliters of benzene, and mix.
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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 necessary, by percolation through activated paper (18.5 centimeters, Schleicher & silica gel or by distillation. Schuell, No. 597, or equivalent). If the initial Methyl alcohol, A.C.S. reagent grade. Use filtrate contains carbon fines, refilter 10.0 milliliters of methyl alcohol. Purify, if through the same filter until a clear filtrate necessary, by distillation. is obtained. Protect the sulfoxide from air Dimethyl sulfoxide. Pure grade, clear, and moisture during this operation by cov- water-white, m.p. 18° minimum. Dilute 120 ering the solvent in the funnel and collection milliliters of dimethyl sulfoxide with 240 flask with a layer of isooctane. Transfer the milliliters of distilled water in a 500–milli- filtrate to a 2–liter separatory funnel and liter separatory funnel, mix and allow to draw off the dimethyl sulfoxide into the 2– cool for 5–10 minutes. Add 40 milliliters of liter distillation flask of the vacuum dis- isooctane to the solution and extract by tillation assembly and distill at approxi- shaking the funnel vigorously for 2 minutes. mately 3–millimeter Hg pressure or less. Dis- Draw off the lower aqueous layer into a sec- card the first 200–milliliter fraction of the ond 500–milliliter separatory funnel and re- distillate and replace the distillate collec- peat the extraction with 40 milliliters of iso- tion flask with a clean one. Continue the dis- octane. Draw off and discard the aqueous tillation until approximately 1 liter of the layer. Wash each of the 40–milliliter extrac- sulfoxide has been collected. tives three times with 50–milliliter portions At completion of the distillation, the rea- of distilled water. Shaking time for each gent should be stored in glass-stoppered bot- wash is 1 minute. Discard the aqueous lay- tles since it is very hygroscopic and will ers. Filter the first extractive through anhy- react with some metal containers in the drous sodium sulfate prewashed with iso- presence of air. octane (see Sodium sulfate under ‘‘Reagents Phosphoric acid. 85 percent A.C.S. reagent and Materials’’ for preparation of filter), into grade. a 250–milliliter Erlenmeyer flask, or option- ally into the evaporating flask. Wash the Sodium borohydride. 98 percent. first separatory funnel with the second 40– Magnesium oxide (Sea Sorb 43, Food Machin- milliliter isooctane extractive, and pass ery Company, Westvaco Division, distributed by through the sodium sulfate into the flask. chemical supply firms, or equivalent). Place 100 Then wash the second and first separatory grams of the magnesium oxide in a large funnels successively with a 10–milliliter por- beaker, add 700 milliliters of distilled water tion of isooctane, and pass the solvent to make a thin slurry, and heat on a steam through the sodium sulfate into the flask. bath for 30 minutes with intermittent stir- Add 1 milliliter of n-hexadecane and evapo- ring. Stir well initially to insure that all the rate the isooctane on the steam bath under absorbent is completely wetted. Using a nitrogen. Discontinue evaporation when not Buchner funnel and a filter paper (Schleicher over 1 milliliter of residue remains. To the & Schuell No. 597, or equivalent) of suitable residue, add a 10–milliliter portion of iso- diameter, filter with suction. Continue suc- octane and reevaporate to 1 milliliter of tion until water no longer drips from the hexadecane. Again, add 10 milliliters of iso- funnel. Transfer the absorbent to a glass octane to the residue and evaporate to 1 mil- trough lined with aluminum foil (free from liliter of hexadecane to insure complete re- rolling oil). Break up the magnesia with a moval of all volatile materials. Dissolve the clean spatula and spread out the absorbent 1 milliliter of hexadecane in isooctane and on the aluminum foil in a layer about 1 cen- make to 25–milliliter volume. Determine the timeter to 2 centimeters thick. Dry for 24 reference. The absorbance of the solution hours at 160 °C ±1 °C. Pulverize the magnesia should not exceed 0.02 per centimeter path with mortar and pestle. Sieve the pulverized length in the 280 mµ–400 mµ range. (NOTE.— absorbent between 60–180 mesh. Use the mag- Difficulty in meeting this absorbance speci- nesia retained on the 180–mesh sieve. fication may be due to organic impurities in Celite 545. Johns-Manville Company, diato- the distilled water. Repetition of the test maceous earth, or equivalent. omitting the dimethyl sulfoxide will disclose Magnesium oxide-Celite 545 mixture (2+ 1) by their presence. If necessary to meet the spec- weight. Place the magnesium oxide (60–180 ification, purify the water by redistillation, mesh) and the Celite 545 in 2 to 1 propor- passage through an ion-exchange resin, or tions, respectively, by weight in a glass- otherwise.) stoppered flask large enough for adequate Purify, if necessary, by the following pro- mixing. Shake vigorously for 10 minutes. cedure: To 1,500 milliliters of dimethyl sulf- Transfer the mixture to a glass trough lined oxide in a 2–liter glass-stoppered flask, add with aluminum foil (free from rolling oil)
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and spread it out on a layer about 1 centi- been heated in the heating jacket at a tem- meter to 2 centimeters thick. Reheat the perature just high enough to keep the wax mixture at 160 °C ±1 °C for 2 hours, and store melted. (NOTE: In preheating the sulfoxide- in a tightly closed flask. acid mixture, remove the stopper of the sepa- Sodium sulfate, anhydrous, A.C.S. reagent ratory funnel at intervals to release the grade, preferably in granular form. For each pressure.) bottle of sodium sulfate reagent used, estab- Promptly complete the transfer of the lish as follows the necessary sodium sulfate sample to the funnel in the jacket with por- prewash to provide such filters required in tions of the preequilibrated isooctane, warm- the method: Place approximately 35 grams of ing the beaker, if necessary, and using a anhydrous sodium sulfate in a 30–milliliter total volume of just 50 milliliters of the sol- coarse, fritted-glass funnel or in a 65–milli- vent. If the wax comes out of solution during meter filter funnel with glass wool plug; these operations, let the stoppered funnel re- wash with successive 15–milliliter portions of main in the jacket until the wax redissolves. the indicated solvent until a 15–milliliter (Remove stopper from the funnel at intervals portion of the wash shows 0.00 absorbance to release pressure.) When the wax is in solu- per centimeter path length between 280 mµ tion, remove the funnel from the jacket and and 400 mµ when tested as prescribed under shake it vigorously for 2 minutes. Set up ‘‘Organic solvents.’’ Usually three portions three 250–milliliter separatory funnels with of wash solvent are sufficient. each containing 30 milliliters of Before proceeding with analysis of a sam- preequilibrated isooctane. After separation ple, determine the absorbance in a 5–centi- of the liquid phases, allow to cool until the meter path cell between 250 mµ and 400 mµ main portion of the wax-isooctane solution for the reagent blank by carrying out the begins to show a precipitate. Gently swirl procedure, without a wax sample, at room the funnel when precipitation first occurs on temperature, recording the spectra after the the inside surface of the funnel to accelerate extraction stage and after the complete pro- this process. Carefully draw off the lower cedure as prescribed. The absorbance per layer, filter it slowly through a thin layer of centimeter path length following the extrac- glass wool fitted loosely in a filter funnel tion stage should not exceed 0.040 in the into the first 250–milliliter separatory fun- wavelength range from 280 mµ to 400 mµ; the nel, and wash in tandem with the 30–milli- absorbance per centimeter path length fol- liter portions of isooctane contained in the lowing the complete procedure should not 250–milliliter separatory funnels. Shaking exceed 0.070 in the wavelength range from 280 time for each wash is 1 minute. Repeat the mµ to 299 mµ, inclusive, nor 0.045 in the extraction operation with two additional wavelength range from 300 mµ to 400 mµ. If in portions of the sulfoxide-acid mixture, re- either spectrum the characteristic benzene placing the funnel in the jacket after each peaks in the 250 mµ–260 mµ region are extraction to keep the wax in solution and present, remove the benzene by the proce- washing each extractive in tandem through dure under ‘‘Organic solvents’’ and record the same three portions of isooctane. absorbance again. Collect the successive extractives (300 mil- Place 300 milliliters of dimethyl sulfoxide liliters total) in a separatory funnel (pref- in a 1–liter separatory funnel and add 75 mil- erably 2–liter), containing 480 milliliters of liliters of phosphoric acid. Mix the contents distilled water, mix, and allow to cool for a of the funnel and allow to stand for 10 min- few minutes after the last extractive has utes. (The reaction between the sulfoxide been added. Add 80 milliliters of isooctane to and the acid is exothermic. Release pressure the solution and extract by shaking the fun- after mixing, then keep funnel stoppered.) nel vigorously for 2 minutes. Draw off the Add 150 milliliters of isooctane and shake to lower aqueous layer into a second separatory preequilibrate the solvents. Draw off the in- funnel (preferably 2–liter) and repeat the ex- dividual layers and store in glass-stoppered traction with 80 milliliters of isooctane. flasks. Draw off and discard the aqueous layer. Place a representative 1–kilogram sample Wash each of the 80–milliliter extractives of wax, or if this amount is not available, the three times with 100–milliliter portions of entire sample, in a beaker of a capacity distilled water. Shaking time for each wash about three times the volume of the sample is 1 minute. Discard the aqueous layers. Fil- and heat with occasional stirring on a steam ter the first extractive through anhydrous bath until the wax is completely melted and sodium sulfate prewashed with isooctane (see homogeneous. Weigh four 25–gram ±0.2 gram Sodium Sulfate under ‘‘Reagents and Mate- portions of the melted wax in separate 100– rials’’ for preparation of filter) into a 250– milliliter beakers. Reserve three of the por- milliliter Erlenmeyer flask (or optionally tions for later replicate analyses as nec- into the evaporation flask). Wash the first essary. Pour one weighed portion imme- separatory funnel with the second 80–milli- diately after remelting (on the steam bath) liter isooctane extractive and pass through into a 500–milliliter separatory funnel con- the sodium sulfate. Then wash the second taining 100 milliliters of the preequilibrated and first separatory funnels successively sulfoxide-phosphoric acid mixture that has with a 20–milliliter portion of isooctane and
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pass the solvent through the sodium sulfate layer. Continue packing in this manner until into the flask. Add 1 milliliter of n-hexa- all the 14 grams of the adsorbent is added to decane and evaporate the isooctane on the the tube. Level off the top of the adsorbent steam bath under nitrogen. Discontinue by pressing down firmly with a flat glass rod evaporation when not over 1 milliliter of res- or metal plunger to make the depth of the idue remains. To the residue, add a 10–milli- adsorbent bed approximately 12.5 centi- liter portion of isooctane, reevaporate to 1 meters in depth. Turn off the vacuum and re- milliliter of hexadecane, and repeat this op- move the suction flask. Fit the 500–milliliter eration once. reservoir onto the top of the Quantitatively transfer the residue with chromatographic column and prewet the col- isooctane to a 25–milliliter volumetric flask, umn by passing 100 milliliters of isooctane make to volume, and mix. Determine the ab- through the column. Adjust the nitrogen sorbance of the solution in the 5–centimeter pressure so that the rate of descent of the path length cells compared to isooctane as isooctane coming off of the column is be- reference between 280 mµ–400 mµ (take care tween 2–3 milliliters per minute. Discontinue to lose none of the solution in filling the pressure just before the last of the isooctane sample cell). Correct the absorbance values reaches the level of the adsorbent. (CAUTION: for any absorbance derived from reagents as Do not allow the liquid level to recede below determined by carrying out the procedure the adsorbent level at any time.) Remove the without a wax sample. If the corrected ab- reservoir and decant the 5–milliliter iso- sorbance does not exceed the limits pre- octane concentrate solution onto the column scribed in this paragraph (b), the wax meets and with slight pressure again allow the liq- the ultraviolet absorbance specifications. If uid level to recede to barely above the ad- the corrected absorbance per centimeter sorbent level. Rapidly complete the transfer path length exceeds the limits prescribed in similarly with two 5–milliliter portions of this paragraph (b), proceed as follows: isooctane, swirling the flask repeatedly each Quantitatively transfer the isooctane solu- time to assure adequate washing of the res- tion to a 125–milliliter flask equipped with idue. Just before the final 5–milliliter wash 24/40 joint and evaporate the isooctane on reaches the top of the adsorbent, add 100 mil- the steam bath under a stream of nitrogen to liliters of isooctane to the reservoir and con- a volume of 1 milliliter of hexadecane. Add tinue the percolation at the 2–3 milliliter per 10 milliliters of methyl alcohol and approxi- minute rate. Just before the last of the iso- mately 0.3 gram of sodium borohydride. octane reaches the adsorbent level, add 100 (Minimize exposure of the borohydride to the milliliters of 10 percent benzene in isooctane atmosphere. A measuring dipper may be to the reservoir and continue the percolation used.) Immediately fit a water-cooled con- at the aforementioned rate. Just before the denser equipped with a 24/40 joint and with a solvent mixture reaches adsorbent level, add drying tube into the flask, mix until the 25 milliliters of 20 percent benzene in iso- borohydride is dissolved, and allow to stand octane to the reservoir and continue the per- for 30 minutes at room temperature, with colation at 2–3 milliliters per minute until intermittent swirling. At the end of this pe- all this solvent mixture has been removed riod, disconnect the flask and evaporate the from the column. Discard all the elution sol- methyl alcohol on the steam bath under ni- vents collected up to this point. Add 300 mil- trogen until the sodium borohydride begins liliters of the acetone-benzene-water mixture to come out of the solution. Then add 10 mil- to the reservoir and percolate through the liliters of isooctane and evaporate to a vol- column to elute the polynuclear compounds. ume of about 2–3 milliliters. Again, add 10 Collect the eluate in a clean 1–liter sepa- milliliters of isooctane and concentrate to a ratory funnel. Allow the column to drain volume of approximately 5 milliliters. Swirl until most of the solvent mixture is re- the flask repeatedly to assure adequate moved. Wash the eluate three times with washing of the sodium borohydride residues. 300–milliliter portions of distilled water, Fit the tetrafluoroethylene polymer disc shaking well for each wash. (The addition of on the upper part of the stem of the small amounts of sodium chloride facilitates chromatographic tube, then place the tube separation.) Discard the aqueous layer after with the disc on the suction flask and apply each wash. After the final separation, filter the vacuum (approximately 135 millimeters the residual benzene through anhydrous so- Hg pressure). Weight out 14 grams of the 2:1 dium sulfate prewashed with benzene (see So- magnesium oxide-Celite 545 mixture and dium sulfate under ‘‘Reagents and Materials’’ pour the adsorbent mixture into the for preparation of filter) into a 250–milliliter chromatographic tube in approximately 3– Erlenmeyer flask (or optionally into the centimeter layers. After the addition of each evaporation flask). Wash the separatory fun- layer, level off the top of the adsorbent with nel with two additional 20–milliliter portions a flat glass rod or metal plunger by pressing of benzene which are also filtered through down firmly until the adsorbent is well the sodium sulfate. Add 1 milliliter of n- packed. Loosen the topmost few millimeters hexadecane and completely remove the ben- of each adsorbent layer with the end of a zene by evaporation under nitrogen, using metal rod before the addition ofthe next the special procedure to eliminate benzene
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as previously described under ‘‘Organic Sol- Office of the Federal Register, 800 vents.’’ Quantitatively transfer the residue North Capitol St. NW., suite 700, Wash- with isooctane to a 25–milliliter volumetric ington, DC. Petroleum wax shall con- flask and adjust to volume. Determine the tain not more than 1,050 parts per mil- absorbance of the solution in the 5–centi- meter path length cells compared to iso- lion of poly(alkylacrylate) or octane as reference between 250 mµ–400 mµ. poly(alkylmethacrylate) residues as Correct for any absorbance derived from the determined by a method entitled reagents as determined by carrying out the ‘‘Method for Determining Residual procedure without a wax sample. If either Level of Poly(alkylacrylate) in Petro- spectrum shows the characteristic benzene leum Wax,’’ which is incorporated by peaks in the 250 mµ–260 mµ region, evaporate reference. Copies are available from the solution to remove benzene by the proce- the addresses cited in this paragraph. dure under ‘‘Organic Solvents.’’ Dissolve the (d) Petroleum wax is used or intended residue, transfer quantitatively, and adjust to volume in isooctane in a 25–milliliter vol- for use as follows: umetric flask. Record the absorbance again. Use Limitations If the corrected absorbance does not exceed the limits prescribed in this paragraph (b), In chewing gum base, as a mas- In an amount not to ex- the wax meets the ultraviolet absorbance ticatory substance. ceed good manufac- specifications. turing practice. On cheese and raw fruits and Do. (c) Petroleum wax may contain one vegetables as a protective coat- or more of the following adjuvants in ing. As a defoamer in food ...... In accordance with amounts not greater than that re- § 173.340 of this chap- quired to produce their intended effect: ter. (1) Antioxidants permitted in food by As a component of microcapsules In accordance with for spice-flavoring substances. § 172.230 of this chap- regulations issued in accordance with ter. section 409 of the act. (2) Poly(alkylacrylate) (CAS Reg. No. [42 FR 14491, Mar. 15, 1977, as amended at 45 27029–57–8), made from long chain (C16– FR 48123, July 18, 1980; 47 FR 11838, Mar. 19, C22) alcohols and acrylic acid, or 1982; 50 FR 32561, Aug. 13, 1985; 51 FR 19544, poly(alkylmethacrylate) (CAS Reg. No. May 30, 1986; 54 FR 24897, June 12, 1989; 64 FR 179529–36–3), made from long chain (C18– 44122, Aug. 13, 1999] C22) methacrylate esters, having: (i) A number average molecular § 172.888 Synthetic petroleum wax. weight between 40,000 and 100,000; Synthetic petroleum wax may be (ii) A weight average molecular safely used in or on foods in accordance weight (MWw) to number average mo- with the following conditions: lecular weight (MWn) ratio (MWw/MWn) (a) Synthetic petroleum wax is a of not less than 3; and mixture of solid hydrocarbons, par- (iii) Unreacted alkylacrylate or affinic in nature, prepared by either alkylmethacrylate monomer content catalytic polymerization of ethylene or not in excess of 14 percent, as deter- copolymerization of ethylene with lin- mined by a method entitled ‘‘Method ear (C3 to C12) alpha-olefins, and refined for Determining Weight-Average and to meet the specifications prescribed in Number-Average Molecular Weight and this section. for Determining Alkylacrylate Mon- (b) Synthetic petroleum wax meets omer Content of Poly(alkylacrylate) the ultraviolet absorbance limits of used as Processing Aid in Manufacture § 172.886(b) when subjected to the ana- of Petroleum Wax,’’ which is incor- lytical procedure described therein. porated by reference in accordance (c) Synthetic petroleum wax has a with 5 U.S.C. 552(a) and 1 CFR part 51. number average molecular weight of Copies are available from the Office of not less than 500 nor greater than 1,200 Premarket Approval (HFS–200), Center as determined by vapor pressure os- for Food Safety and Applied Nutrition, mometry. Food and Drug Administration, 200 C (d) Synthetic petroleum wax may St. SW., Washington, DC 20204, or may contain any antioxidant permitted in be examined at the Center for Food food by regulations issued in accord- Safety and Applied Nutrition’s Li- ance with section 409 of the act, in an brary, Food and Drug Administration, amount not greater than that required 200 C St. SW., Washington, DC or at the to produce its intended effect.
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(e) Synthetic petroleum wax is used Limitations or intended for use as follows: Active oxygen obtained from hy- Use Limitations drogen peroxide and/or per- acetic acid, not to exceed 0.45 In chewing gum base, as a In accordance with § 172.615 percent of active oxygen. masticatory substance. in an amount not to exceed Ammonium persulfate, not to ex- good manufacturing prac- ceed 0.075 percent and sulfur tice. dioxide, not to exceed 0.05 per- On cheese and raw fruits and In an amount not to exceed cent. vegetables as a protective good manufacturing prac- Chlorine, as calcium hypochlorite, The finished food starch- coating. tice. not to exceed 0.036 percent of modified is limited to As a defoamer in food ...... In accordance with § 173.340 dry starch. use only as a compo- of this chapter. nent of batter for com- mercially processed foods. [42 FR 14491, Mar. 15, 1977, as amended at 59 Chlorine, as sodium hypochlorite, FR 10986, Mar. 9, 1994] not to exceed 0.0082 pound of chlorine per pound of dry starch. § 172.890 Rice bran wax. Potassium permanganate, not to Residual manganese exceed 0.2 percent. (calculated as Mn), not Rice bran wax may be safely used in to exceed 50 parts per food in accordance with the following million in food starch- conditions: modified. Sodium chlorite, not to exceed 0.5 (a) It is the refined wax obtained percent. from rice bran and meets the following specifications: (c) Food starch may be oxidized by Melting point 75 °C to 80 °C. treatment with chlorine, as sodium hy- Free fatty acids, maximum 10 percent. pochlorite, not to exceed 0.055 pound of Iodine number, maximum 20. chlorine per pound of dry starch. Saponification number 75 to 120. (d) Food starch may be esterified by (b) It is used or intended for use as treatment with one of the following: follows: Limitations Food Limitation in food Use Acetic anhydride ...... Acetyl groups in food Candy ...... 50 p.p.m ...... Coating. starch-modified not to Fresh fruits and fresh ...... do ...... Do. exceed 2.5 percent. vegetables. Adipic anhydride, not to exceed Do. Chewing gum ...... 21⁄2 pct ...... Plasticizing 0.12 percent, and acetic anhy- material. dride. Monosodium orthophosphate ...... Residual phosphate in food starch-modified § 172.892 Food starch-modified. not to exceed 0.4 per- Food starch-modified as described in cent calculated as phosphorus. this section may be safely used in food. 1ÐOctenyl succinic anhydride, not The quantity of any substance em- to exceed 3 percent. ployed to effect such modification shall 1ÐOctenyl succinic anhydride, not not exceed the amount reasonably re- to exceed 2 percent, and alu- minum sulfate, not to exceed 2 quired to accomplish the intended percent. physical or technical effect, nor exceed 1-Octenyl succinic anhydride, not Limited to use as a sta- any limitation prescribed. To insure to exceed 3 percent, followed bilizer or emulsifier in safe use of the food starch-modified, by treatment with a beta-amy- beverages and bev- lase enzyme that is either an erage bases as de- the label of the food additive container approved food additive of is fined in ¤ 170.3(n)(3) of shall bear the name of the additive generally recognized as safe. this chapter. ‘‘food starch-modified’’ in addition to Phosphorus oxychloride, not to other information required by the Act. exceed 0.1 percent. Phosphorus oxychloride, not to Acetyl groups in food Food starch may be modified by treat- exceed 0.1 percent, followed by starch-modified not to ment prescribed as follows: either acetic anhydride, not to exceed 2.5 percent. (a) Food starch may be acid-modified exceed 8 percent, or vinyl ace- by treatment with hydrochloric acid or tate, not to exceed 7.5 percent. Sodium trimetaphosphate ...... Residual phosphate in sulfuric acid or both. food starch-modified (b) Food starch may be bleached by not to exceed 0.04 treatment with one or more of the fol- percent, calculated as lowing: phosphorus.
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Limitations scribed by paragraphs (a), (b), and/or (i) of this section and any one of the Sodium tripolyphosphate and so- Residual phosphate in dium trimetaphosphate. food starch-modified treatments prescribed by paragraph (c), not to exceed 0.4 per- (d), (e), (f), or (g) of this section, sub- cent calculated as ject to any limitations prescribed by phosphorus. the paragraphs named. Succinic anhydride, not to exceed 4 percent. (i) Food starch may be modified by Vinyl acetate ...... Acetyl groups in food treatment with the following enzyme: starch-modified not to exceed 2.5 percent. Enzyme Limitations
Alpha-amylase (E.C. 3.2.1.1) ...... The enzyme must be (e) Food starch may be etherified by generally recognized treatment with one of the following: as safe or approved as a food additive for this Limitations purpose. The resulting nonsweet nutritive sac- Acrolein, not to exceed 0.6 per- charide polymer has a cent. dextrose equivalent of Epichlorohydrin, not to exceed less than 20. 0.3 percent. Epichlorohydrin, not to exceed Residual propylene 0.1 percent, and propylene chlorohydrin not more [42 FR 14491, Mar. 15, 1977, as amended at 43 oxide, not to exceed 10 per- than 5 parts per million FR 11697, Mar. 21, 1978; 46 FR 32015, June 19, cent, added in combination or in food starch-modified. 1981; 57 FR 54700, Nov. 20, 1992; 58 FR 21100, in any sequence. Apr. 19, 1993] Epichlorohydrin, not to exceed Do. 0.1 percent, followed by pro- pylene oxide, not to exceed 25 § 172.894 Modified cottonseed products percent. intended for human consumption. Propylene oxide, not to exceed Do. The food additive modified cotton- 25 percent. seed products may be used for human (f) Food starch may be esterified and consumption in accordance with the etherified by treatment with one of the following prescribed conditions: (a) The additive is derived from: following: (1) Decorticated, partially defatted, Limitations cooked, ground cottonseed kernels; or (2) Decorticated, ground cottonseed Acrolein, not to exceed 0.6 per- Acetyl groups in food cent and vinyl acetate, not to starch-modified not to kernels, in a process that utilizes n- exceed 7.5 percent. exceed 2.5 percent. hexane as an extracting solvent in such Epichlorohydrin, not to exceed 0.3 Acetyl groups in food a way that no more than 60 parts per percent, and acetic anhydride. starch-modified not to million of n-hexane residues and less exceed 2.5 percent. Epichlorohydrin, not to exceed 0.3 than 1 percent fat by weight remain in percent, and succinic anhy- the finished product; or dride, not to exceed 4 percent. (3) Glandless cottonseed kernels Phosphorus oxychloride, not to Residual propylene roasted to attain a temperature of not exceed 0.1 percent, and pro- chlorohydrin not more pylene oxide, not to exceed 10 than 5 parts per million less than 250 °F in the kernel for not percent. in food starch-modi- less than 5 minutes for use as a snack fied. food, or in baked goods, or in soft candy; or (g) Food starch may be modified by (4) Raw glandless cottonseed kernels treatment with one of the following: may be used in hard candy where the Limitations kernel temperature during cooking will exceed 250 °F for not less than 5 Chlorine, as sodium hypochlorite, Residual propylene minutes. not to exceed 0.055 pound of chlorohydrin not more chlorine per pound of dry than 5 parts per million (b) The additive is prepared to meet starch; 0.45 percent of active in food starch-modi- the following specifications: oxygen obtained from hydrogen fied. (1) Free gossypol content not to ex- peroxide; and propylene oxide, ceed 450 parts per million. not to exceed 25 percent. Sodium hydroxide, not to exceed (2) It contains no added arsenic com- 1 percent. pound and therefore may not exceed a maximum natural background level of (h) Food starch may be modified by a 0.2 part per million total arsenic, cal- combination of the treatments pre- culated as As.
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(c) To assure safe use of the additive, (1) Less than 10,000 organisms/gram the label of the food additive container by aerobic plate count. shall bear, in addition to other infor- (2) Less than 10 yeasts and molds/ mation required by the act, the name gram. of the additive as follows: (3) Negative for Salmonella, E. coli, (1) The additive identified in para- coagulase positive Staphylococci, Clos- graph (a)(1) of this section as ‘‘par- tridium perfringens, Clostridium botu- tially defatted, cooked cottonseed linum, or any other recognized micro- flour’’. bial pathogen or any harmful microbial (2) The additive identified in para- toxin. graph (a)(2) of this section as ‘‘defatted (d) The additive is used or intended cottonseed flour’’. for use in the following foods when (3) The additive identified in para- standards of identity established under graph (a)(3) of this section as ‘‘roasted section 401 of the Act do not preclude glandless cottonseed kernels’’. such use:
(4) The additive identified in para- Use Limitations graph (a)(4) of this section as ‘‘raw glandless cottonseed kernels for use in (1) In salad dressings as an emul- Not to exceed a con- cooked hard candy’’. sifier and emulsifier salt as de- centration of 5 percent fined in ¤ 170.3(o)(8) of this of the finished salad (d) The Food and Drug Administra- chapter, stabilizer and thickener dressing. tion and the Environmental Protection as defined in ¤ 170.3(o)(28) of Agency have determined that glandless this chapter, or texturizer as de- fined in ¤ 170.3(o)(32) of this cottonseed kernels permitted for use chapter. by this section are a distinct com- (2) In frozen dessert analogs as a In an amount not to ex- modity from glanded cottonseed. stabilizer and thickener as de- ceed good manufac- fined in ¤ 170.3(o)(28) of this turing practice. chapter, or texturizer as defined § 172.896 Dried yeasts. in ¤ 170.3(o)(32) of this chapter. Dried yeast (Saccharomyces cerevisiae (3) In sour cream analogs as a Do. stabilizer and thickener as de- and Saccharomyces fragilis) and dried fined in ¤ 170.3(o)(28) of this torula yeast (Candida utilis) may be chapter, or texturizer as defined safely used in food provided the total in ¤ 170.3(o)(32) of this chapter. (4) In cheese spread analogs as Do. folic acid content of the yeast does not a stabilizer and thickener as de- exceed 0.04 milligram per gram of yeast fined in ¤ 170.3(o)(28) of this (approximately 0.008 milligram of chapter, or texturizer as defined pteroyglutamic acid per gram of in ¤ 170.3(o)(32) of this chapter. (5) In cheese-flavored and sour Do. yeast). cream-flavored snack dips as a stabilizer and thickener as de- § 172.898 Bakers yeast glycan. fined in ¤ 170.3(o)(28) of this chapter, or texturizer as defined Bakers yeast glycan may be safely in ¤ 170.3(o)(32) of this chapter. used in food in accordance with the fol- lowing conditions: (e) The label and labeling of the in- (a) Bakers yeast glycan is the gredient shall bear adequate directions comminuted, washed, pasteurized, and to assure that use of the ingredient dried cell walls of the yeast, Saccharo- complies with this regulation. myces cerevisiae. It is composed prin- [42 FR 14491, Mar. 15, 1977, as amended at 45 cipally of long chain carbohydrates, FR 58836, Sept. 5, 1980] not less than 85 percent on a dry solids basis. The carbohydrate is composed of PART 173—SECONDARY DIRECT glycan and mannan units in approxi- mately a 2:1 ratio. FOOD ADDITIVES PERMITTED IN (b) The additive meets the following FOOD FOR HUMAN CONSUMP- specifications on a dry weight basis: TION Less than 0.4 part per million (ppm) ar- senic, 0.13 ppm cadmium, 0.2 ppm lead, Subpart A—Polymer Substances and 0.05 ppm mercury, 0.09 ppm selenium, Polymer Adjuvants for Food Treatment and 10 ppm zinc. Sec. (c) The viable microbial content of 173.5 Acrylate-acrylamide resins. the finished ingredient is: 173.10 Modified polyacrylamide resin.
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173.20 Ion-exchange membranes. 173.342 Chlorofluorocarbon 113 and 173.21 Perfluorinated ion exchange mem- perfluorohexane. branes. 173.345 Chloropentafluoroethane. 173.25 Ion-exchange resins. 173.350 Combustion product gas. 173.40 Molecular sieve resins. 173.355 Dichlorodifluoromethane. 173.45 Polymaleic acid and its sodium salt. 173.357 Materials used as fixing agents in 173.50 Polyvinylpolypyrrolidone. the immobilization of enzyme prepara- 173.55 Polyvinylpyrrolidone. tions. 173.60 Dimethylamine-epichlorohydrin co- 173.360 Octafluorocyclobutane. polymer. 173.370 Peroxyacids. 173.65 Divinylbenzene copolymer. 173.385 Sodium methyl sulfate. 173.70 Chloromethylated aminated styrene- 173.395 Trifluoromethane sulfonic acid. divinylbenzene resin. 173.400 Dimethyldialkylammonium chlo- 173.73 Sodium polyacrylate. ride. 173.75 Sorbitan monooleate. AUTHORITY: 21 U.S.C. 321, 342, 348. Subpart B—Enzyme Preparations and SOURCE: 42 FR 14526, Mar. 15, 1977, unless Microorganisms otherwise noted. EDITORIAL NOTE: Nomenclature changes to 173.110 Amyloglucosidase derived from part 173 appear at 61 FR 14482, Apr. 2, 1996. Rhizopus niveus. 173.120 Carbohydrase and cellulase derived from Aspergillus niger. Subpart A—Polymer Substances 173.130 Carbohydrase derived from Rhizopus and Polymer Adjuvants for oryzae. Food Treatment 173.135 Catalase derived from Microccocus lysodeikticus. § 173.5 Acrylate-acrylamide resins. 173.140 Esterase-lipase derived from Mucor miehei. Acrylate-acrylamide resins may be 173.145 Alpha-Galactosidase derived from safely used in food under the following Mortierella vinaceae var. raffinoseutilizer. prescribed conditions: 173.150 Milk-clotting enzymes, microbial. (a) The additive consists of one of the 173.160 Candida guilliermondii. following: 173.165 Candida lipolytica. (1) Acrylamide-acrylic acid resin ′ 173.170 Aminoglycoside 3 - (hydrolyzed polyacrylamide) is pro- phosphotransferase II. duced by the polymerization of acryl- Subpart C—Solvents, Lubricants, Release amide with partial hydrolysis, or by Agents and Related Substances copolymerization of acrylamide and acrylic acid, with the greater part of 173.210 Acetone. the polymer being composed of acryl- 173.220 1,3–Butylene glycol. amide units. 173.228 Ethyl acetate. (2) Sodium polyacrylate-acrylamide 173.230 Ethylene dichloride. resin is produced by the polymerization 173.240 Isopropyl alcohol. 173.250 Methyl alcohol residues. and subsequent hydrolysis of acrylo- 173.255 Methylene chloride. nitrile in a sodium silicate-sodium hy- 173.270 Hexane. droxide aqueous solution, with the 173.275 Hydrogenated sperm oil. greater part of the polymer being com- 173.280 Solvent extraction process for citric posed of acrylate units. acid. (b) The additive contains not more 173.290 Trichloroethylene. than 0.05 percent of residual monomer calculated as acrylamide. Subpart D—Specific Usage Additives (c) The additive is used or intended 173.300 Chlorine dioxide. for use as follows: 173.310 Boiler water additives. (1) The additive identified in para- 173.315 Chemicals used in washing or to as- graph (a) (1) of this section is used as a sist in the peeling of fruits and vegeta- flocculent in the clarification of beet bles. sugar juice and liquor or cane sugar 173.320 Chemicals for controlling micro- juice and liquor or corn starch organisms in cane-sugar and beet-sugar hydrolyzate in an amount not to ex- mills. 173.322 Chemicals used in delinting cotton- ceed 5 parts per million by weight of seed. the juice or 10 parts per million by 173.325 Acidified sodium chlorite solutions. weight of the liquor or the corn starch 173.340 Defoaming agents. hydrolyzate.
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(2) The additive identified in para- brane weighing approximately 14 grams graph (a)(2) of this section is used to each are cut into small pieces and control organic and mineral scale in refluxed for 4 hours in 150 cubic centi- beet sugar juice and liquor or cane meters of the following solvents: Dis- sugar juice and liquor in an amount tilled water, 5 percent acetic acid, and not to exceed 2.5 parts per million by 50 percent alcohol. Extraction from weight of the juice or liquor. each sample will not exceed 0.4 percent [42 FR 14526, Mar. 15, 1977, as amended at 46 by weight of sample. FR 30494, June 9, 1981] (c) The ion-exchange membrane will be used in the production of grapefruit § 173.10 Modified polyacrylamide juice to adjust the ratio of citric acid resin. to total solids of the grapefruit juice Modified polyacrylamide resin may produced. be safely used in food in accordance with the following prescribed condi- § 173.21 Perfluorinated ion exchange tions: membranes. (a) The modified polyacrylamide Substances identified in paragraph resin is produced by the copolymeriza- (a) of this section may be safely used as tion of acrylamide with not more than ion exchange membranes intended for β 5–mole percent -methacrylyloxyethy- use in the treatment of bulk quantities ltrimethylammonium methyl sulfate. of liquid food under the following pre- (b) The modified polyacrylamide scribed conditions: resin contains not more than 0.05 per- (a) Identity. The membrane is a co- cent residual acrylamide. polymer of ethanesulfonyl fluoride, 2- (c) The modified polyacrylamide resin is used as a flocculent in the clar- [1-[difluoro-[(trifluoro- ification of beet or cane sugar juice in ethenyl)oxy]methyl]-1,2,2,2-tetrafluoro- an amount not exceeding 5 parts per ethoxy]-1,1,2,2,-tetrafluoro-, with tetra- million by weight of the juice. fluoroethylene that has been subse- (d) To assure safe use of the additive, quently treated to hydrolyze the the label and labeling of the additive sulfonyl fluoride group to the sulfonic shall bear, in addition to the other in- acid. The Chemical Abstracts Service formation required by the act, ade- name of this polymer is ethanesulfonic quate directions to assure use in com- acid, 2-[1-[difluoro-[(trifluoro- pliance with paragraph (c) of this sec- ethenyl)oxy]methyl]-1,2,2,2-tetrafluoro- tion. ethoxy]-1,1,2,2,-tetrafluoro-, polymer with tetrafluoroethane (CAS Reg. No. § 173.20 Ion-exchange membranes. 31175–20–9). Ion-exchange membranes may be (b) Optional adjuvant substances. The safely used in the processing of food basic polymer identified in paragraph under the following prescribed condi- (a) of this section may contain optional tions: adjuvant substances required in the (a) The ion-exchange membrane is production of such basic polymer. prepared by subjecting a polyethylene These optional adjuvant substances 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
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to prevent microbial adulteration of (11) Sulfonated terpolymers of sty- food. rene, divinylbenzene, and acrylonitrile (4) To assure their safe use, or methyl acrylate. perfluorinated ionomer membranes (12) Methyl acrylate-divinylbenzene shall be thoroughly cleaned prior to copolymer containing not less than 2 their first use in accordance with cur- percent by weight of divinylbenzene, rent good manufacturing practice. aminolyzed with dimethylaminopro- pylamine. [59 FR 15623, Apr. 4, 1994] (13) Methyl acrylate-divinylbenzene § 173.25 Ion-exchange resins. copolymer containing not less than 3.5 percent by weight of divinylbenzene, Ion-exchange resins may be safely aminolyzed with dimethylaminopro- used in the treatment of food under the pylamine. following prescribed conditions: (14) Epichlorohydrin cross-linked (a) The ion-exchange resins are pre- with ammonia. pared in appropriate physical form, and (15) Sulfonated tetrapolymer of sty- consist of one or more of the following: rene, divinylbenzene, acrylonitrile, and (1) Sulfonated copolymer of styrene methyl acrylate derived from a mix- and divinylbenzene. ture of monomers containing not more (2) Sulfonated anthracite coal meet- than a total of 2 percent by weight of ing the requirements of ASTM method acrylonitrile and methyl acrylate. D388–38, Class I, Group 2, ‘‘Standard (16) Methyl acrylate-divinylbenzene- Specifications for Classification of Coal diethylene glycol divinyl ether by Rank,’’ which is incorporated by terpolymer containing not less than 3.5 reference. Copies are available from percent by weight of divinylbenzene University Microfilms International, and not more than 0.6 percent by 300 N. Zeeb Rd., Ann Arbor, MI 48106, or weight of diethylene glycol divinyl available for inspection at the Office of ether, aminolyzed with dimethyl- the Federal Register, 800 North Capitol aminopropylamine. Street, NW., suite 700, Washington, DC (17) Styrene-divinylbenzene cross- 20408. linked copolymer, first (3) Sulfite-modified cross-linked phe- chloromethylated then aminated with nol-formaldehyde, with modification dimethylamine and oxidized with hy- resulting in sulfonic acid groups on drogen peroxide whereby the resin con- side chains. tains not more than 15 percent by (4) Methacrylic acid-divinylbenzene weight of vinyl N,N-dimethylbenzyl- copolymer. amine-N-oxide and not more than 6.5 (5) Cross-linked polystyrene, first percent by weight of nitrogen. chloromethylated then aminated with (18) Methyl acrylate-divinylbenzene- trimethylamine, dimethylamine, di- diethylene glycol divinyl ether ethylenetriamine, or dimethylethanol- terpolymer containing not less than 7 amine. percent by weight of divinylbenzene (6) Diethylenetriamine, triethylene- and not more than 2.3 percent by tetramine, or tetraethylenepentamine weight of diethylene glycol divinyl cross-linked with epichlorohydrin. ether, aminolyzed with dimethyl- (7) Cross-linked phenol-formaldehyde aminopropylamine and quaternized activated with one or both of the fol- with methyl chloride. lowing: Triethylene tetramine and (19) Epichlorohydrin cross-linked tetraethylenepentamine. with ammonia and then quaternized (8) Reaction resin of formaldehyde, with methyl chloride to contain not acetone, and tetraethylenepentamine. more than 18 percent strong base ca- (9) Completely hydrolyzed copoly- pacity by weight of total exchange ca- mers of methyl acrylate and pacity [Chemical Abstracts Service divinylbenzene. name: Oxirane (chloromethyl)-, poly- (10) Completely hydrolyzed mer with ammonia, reaction product terpolymers of methyl acrylate, with chloromethane; CAS Reg. No. divinylbenzene, and acrylonitrile. 68036–99–7].
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(20) Regenerated cellulose, cross- identified in paragraphs (a) (1), (2), and linked and alkylated with epichloro- (11) of this section. hydrin and propylene oxide, then sulfo- (iii) The temperature of the water nated whereby the amount of epi- passing through the resin beds identi- chlorohydrin plus propylene oxide em- fied in paragraphs (b)(1) (i) and (ii) of ployed does not exceed 250 percent by this section is maintained at 30 °C or weight of the starting quantity of cel- less, and the flow rate of the water lulose. passing through the beds is not less (b) Ion-exchange resins are used in than 2 gallons per cubic foot per the purification of foods, including po- minute. table water, to remove undesirable ions (iv) The ion-exchange resins identi- or to replace less desirable ions with fied in paragraph (a) (12) or (16) of this one or more of the following: bicarbon- section are exempted from the require- ate, calcium, carbonate, chloride, hy- ments of paragraph (c)(4) of this sec- drogen, hydroxyl, magnesium, potas- tion, but the strongly acidic cation-ex- sium, sodium, and sulfate except that: change resins referred to in paragraphs The ion-exchange resin identified in (b)(1) (i) and (ii) of this section used in paragraph (a)(12) of this section is used the process meet the requirements of only in accordance with paragraph paragraph (c)(4) of this section, except (b)(1) of this section, the ion-exchange for the exemption described in para- resin identified in paragraph (a)(13) of graph (d) of this section. this section is used only in accordance (2) The ion-exchange resins identified with paragraph (b)(2) of this section, in paragraphs (a) (13) and (16) of this the resin identified in paragraph (a)(16) section are used to treat water and of this section is used only in accord- aqueous food only of the types identi- ance with paragraph (b)(1) or (b)(2) of fied under Categories I, II, and VI–B in this section, the ion-exchange resin table 1 of § 176.170(c) of this chapter: identified in paragraph (a)(17) of this Provided, That the temperature of the section is used only in accordance with water or food passing through the resin paragraph (b)(3) of this section, the ° ion-exchange resin identified in para- beds is maintained at 50 C or less and graph (a)(18) of this section is used only the flow rate of the water or food pass- in accordance with paragraph (b)(4) of ing through the beds is not less than 0.5 this section, and the ion-exchange gallon per cubic foot per minute. resin identified in paragraph (a)(20) of (i) The ion-exchange resin identified this section is used only in accordance in paragraph (a)(13) of this section is with paragraphs (b)(5) and (d) of this used to treat water and aqueous food section. only of the types identified under cat- (1) The ion-exchange resins identified egories I, II, and VI–B in Table 1 of in paragraphs (a) (12) and (16) of this § 176.170(c) of this chapter: Provided, section are used to treat water for use That the temperature of the water or in the manufacture of distilled alco- food passing through the resin bed is holic beverages, subject to the fol- maintained at 50 °C or less and the flow lowing conditions: rate of the water or food passing (i) The water is subjected to treat- through the bed is not less than 0.5 gal- ment through a mixed bed consisting of lon per cubic foot per minute. one of the resins identified in para- (ii) The ion-exchange resin identified graph (a) (12) or (16) of this section and in paragraph (a)(16) of this section is one of the strongly acidic cation-ex- used to treat water and aqueous food change resins in the hydrogen form only of the types identified under cat- identified in paragraphs (a) (1), (2), and egories I, II, and VI–B in Table 1 of (11) of this section; or § 176.170(c) of this chapter, Provided, (ii) The water is first subjected to that either: one of the resins identified in para- (A) The temperature of the water or graph (a) (12) or (16) of this section and food passing through the resin bed is is subsequently subjected to treatment maintained at 50 °C or less and the flow through a bed of activated carbon or rate of the water or food passing one of the strongly acidic cation-ex- through the bed is not less than 0.5 gal- change resins in the hydrogen form lon per cubic foot per minute; or
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(B) Extracts of the resin will be found this section, the pH range for the resin to contain no more than 1 milligram/ shall be no less than 3.5 and no more kilogram dimethylaminopropylamine than 9, and the temperatures of water in each of the food simulants, distilled and food passing through the resin bed water and 10 percent ethanol, when, shall not exceed 25 °C. following washing and pretreatment of (ii) For resins that comply with the the resin in accordance with requirements in paragraph (d)(2)(ii) of § 173.25(c)(1), the resin is subjected to this section, the pH range for the resin the following test under conditions shall be no less than 2 and no more simulating the actual temperature and than 10, and the temperatures of water flow rate of use: ‘‘The Determination of and food passing through the resin 3-Dimethylaminopropylamine in Food shall not exceed 50 °C. Simulating Extracts of Ion Exchange (c) To insure safe use of ion-exchange Resins,’’ February 4, 1998, which is in- resins, each ion-exchange resin will be: corporated by reference in accordance (1) Subjected to pre-use treatment by with 5 U.S.C. 552(a) and 1 CFR part 51. the manufacturer and/or the user in ac- Copies are available from the Division cordance with the manufacturer’s di- of Petition Control (HFS–215), Center rections prescribed on the label or la- for Food Safety and Applied Nutrition, beling accompanying the resins, to Food and Drug Administration, 200 C guarantee a food-grade purity of ion- St. SW., Washington, DC 20204, or may exchange resins, in accordance with be examined at the Center for Food good manufacturing practice. Safety and Applied Nutrition’s Li- (2) Accompanied by label or labeling brary, 200 C St. SW., rm. 3321, Wash- to include directions for use consistent ington, DC, or at the Office of the Fed- with the intended functional purpose of eral Register, 800 North Capitol St. the resin. NW., suite 700, Washington, DC. (3) Used in compliance with the label (3) The ion-exchange resin identified or labeling required by paragraph (c)(2) in paragraph (a)(17) of this section is of this section. used only for industrial application to (4) Found to result in no more than 1 treat bulk quantities of aqueous food, part per million of organic extractives including potable water, or for treat- obtained with each of the named sol- ment of municipal water supplies, sub- vents, distilled water, 15 percent alco- ject to the condition that the tempera- hol, and 5 percent acetic acid when, ture of the food or water passing having been washed and otherwise through the resin bed is maintained at treated in accordance with the manu- 25 °C or less and the flow rate of the facturer’s directions for preparing food or water passing through the bed them for use with food, the ion-ex- is not less than 2 gallons per cubic foot change resin is subjected to the fol- per minute. lowing test: Using a separate ion-ex- (4) The ion-exchange resin identified change column for each solvent, pre- in paragraph (a)(18) of this section is pare columns using 50 milliliters of the used to treat aqueous sugar solutions ready to use ion-exchange resin that is subject to the condition that the tem- to be tested. While maintaining the perature of the sugar solution passing highest temperature that will be en- through the resin bed is maintained at countered in use pass through these 82 °C (179.6 °F) or less and the flow rate beds at the rate of 350–450 milliliters of the sugar solution passing through per hour the three test solvents dis- 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
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ash equals the organic extractives. If (i) The extraction requirement in the organic extractives are greater paragraph (c)(4) of this section by using than 1 part per million of the solvent dilute sulfuric acid, pH 3.5 as a sub- used, a blank should be run on the sol- stitute for acetic acid; or vent and a correction should be made (ii) The extraction requirement in by subtracting the total extractives ob- paragraph (c)(4) of this section by using tained with the blank from the total reagent grade hydrochloric acid, di- extractives obtained in the resin test. luted to pH 2, as a substitute for acetic The solvents used are to be made as acid. The resin shall be found to result follows: in no more than 25 parts per million of Distilled water (de-ionized water is distilled). organic extractives obtained with each 15 percent ethyl alcohol made by mixing 15 of the following solvents: Distilled volumes of absolute ethyl alcohol A.C.S. water; 15 percent alcohol; and hydro- reagent grade, with 85 volumes of distilled chloric acid, pH 2. Blanks should be run de-ionized water. for each of the solvents, and correc- 5 percent acetic acid made by mixing 5 parts tions should be made by subtracting by weight of A.C.S. reagent grade glacial acetic acid with 95 parts by weight of dis- the total extractives obtained with the tilled de-ionized water. blank from the total extractives ob- tained in the resin test. In addition to the organic extractives (e) Acrylonitrile copolymers identi- limitation prescribed in this para- fied in this section shall comply with graph, the ion-exchange resin identi- the provisions of § 180.22 of this chap- fied in paragraph (a)(17) of this section, ter. when extracted with each of the named solvents, distilled water, 50 percent al- [42 FR 14526, Mar. 15, 1977, as amended at 46 cohol, and 5 percent acetic acid, will be FR 40181, Aug. 7, 1981; 46 FR 57033, Nov. 20, found to result in not more than 7 1981; 49 FR 28830, July 17, 1984; 56 FR 16268, parts per million of nitrogen extrac- Apr. 22, 1991; 62 FR 7679, Feb. 20, 1997; 64 FR 14609, Mar. 26, 1999; 64 FR 56173, Oct. 18, 1999] tives (calculated as nitrogen) when the resin in the free-base form is subjected § 173.40 Molecular sieve resins. to the following test immediately be- fore each use: Using a separate 1–inch Molecular sieve resins may be safely diameter glass ion-exchange column used in the processing of food under the for each solvent, prepare each column following prescribed conditions: using 100 milliliters of ready to use ion- (a) The molecular sieve resins consist exchange resin that is to be tested. of purified dextran having an average With the bottom outlet closed, fill each molecular weight of 40,000, cross-linked ion-exchange column with one of the with epichlorohydrin in a ratio of 1 three solvents at a temperature of 25 °C part of dextran to 10 parts of until the solvent level is even with the epichlorohydrin, to give a stable three top of the resin bed. Seal each column dimensional structure. The resins have at the top and bottom and store in a a pore size of 2.0 to 3.0 milliliters per vertical position at a temperature of 25 gram of dry resin (expressed in terms ° C. After 96 hours, open the top of each of water regain), and a particle size of column, drain the solvent into a collec- 10 to 300 microns. tion vessel, and analyze each drained (b) The molecular sieve resins are solvent and a solvent blank for nitro- thoroughly washed with potable water gen by a standard micro-Kjeldahl method. prior to their first use in contact with food. (d)(1) The ion-exchange resins identi- fied in paragraphs (a)(1), (a)(2), (a)(11), (c) Molecular sieve resins are used as and (a)(15) of this section are exempted the gel filtration media in the final pu- from the acetic acid extraction re- rification of partially delactosed whey. quirement of paragraph (c)(4) of this The gel bed shall be maintained in a section. sanitary manner in accordance with (2) The ion-exchange resin identified good manufacturing practice so as to in paragraph (a)(20) of this section prevent microbial build-up on the bed shall comply either with: and adulteration of the product.
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§ 173.45 Polymaleic acid and its so- § 173.50 Polyvinylpolypyrrolidone. dium salt. The food additive polyvinylpoly- Polymaleic acid (CAS Reg. No. 26099– pyrrolidone may be safely used in ac- 09–2) and its sodium salt (CAS Reg. No. cordance with the following prescribed 70247–90–4) may be safely used in food conditions: in accordance with the following pre- (a) The additive is a homopolymer of scribed conditions: (a) The additives have a weight-aver- purified vinylpyrrolidone catalytically age molecular weight in the range of produced under conditions producing 540 to 850 and a number-average molec- polymerization and cross-linking such ular weight in the range of 520 to 650, that an insoluble polymer is produced. calculated as the acid. Molecular (b) The food additive is so processed weights shall be determined by a meth- that when the finished polymer is od entitled ‘‘Determination of Molec- refluxed for 3 hours with water, 5 per- ular Weight Distribution of cent acetic acid, and 50 percent alco- Poly(Maleic) Acid,’’ March 17, 1992, pro- hol, no more than 50 parts per million duced by Ciba-Geigy, Inc., Seven Sky- of extractables is obtained with each line Dr., Hawthorne, NY 10532–2188, solvent. which is incorporated by reference in (c) It is used or intended for use as a accordance with 5 U.S.C. 552(a) and 1 clarifying agent in beverages and vin- CFR part 51. Copies are available from egar, followed by removal with filtra- the Division of Product Policy, Center tion. for Food Safety and Applied Nutrition (HFS–205), Food and Drug Administra- § 173.55 Polyvinylpyrrolidone. tion, 200 C St. SW., Washington, DC 20204, or are available for inspection at The food additive polyvinylpyrroli- the Center for Food Safety and Applied done may be safely used in accordance Nutrition’s Library, 200 C St. SW., rm. with the following prescribed condi- 3321, Washington, DC, or at the Office tions: of the Federal Register, 800 North Cap- (a) The additive is a polymer of puri- itol St. NW., suite 700, Washington, DC. fied vinylpyrrolidone catalytically pro- (b) The additives may be used, indi- duced, having an average molecular vidually or together, in the processing weight of 40,000 and a maximum of beet sugar juice and liquor or of cane unsaturation of 1 percent, calculated as sugar juice and liquor to control min- the monomer, except that the eral scale. polyvinylpyrrolidone used in beer is (c) The additives are to be used so that having an average molecular that the amount of either or both addi- weight of 360,000 and a maximum tives does not exceed 4 parts per mil- lion (calculated as the acid) by weight unsaturation of 1 percent, calculated as of the beet or cane sugar juice or liquor the monomer. process stream. (b) The additive is used or intended for use in foods as follows: [51 FR 5315, Feb. 13, 1986, as amended at 61 FR 386, Jan. 5, 1996]
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.
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§ 173.60 Dimethylamine- (d) To assure safe use of the additive, epichlorohydrin copolymer. the label and labeling of the additive Dimethylamine-epichlorohydrin co- shall bear, in addition to other infor- polymer (CAS Reg. No. 25988–97–0) may mation required by the Act, adequate be safely used in food in accordance directions to assure use in compliance with the following prescribed condi- with paragraph (c) of this section. tions: [48 FR 37614, Aug. 19, 1983, as amended at 54 (a) The food additive is produced by FR 24897, June 12, 1989] copolymerization of dimethylamine and epichlorohydrin in which not more § 173.65 Divinylbenzene copolymer. than 5 mole-percent of dimethylamine Divinylbenzene copolymer may be may be replaced by an equimolar used for the removal of organic sub- amount of ethylenediamine, and in stances from aqueous foods under the which the mole ratio of total amine to following prescribed conditions: epichlorohydrin is approximately 1:1. (a) The copolymer is prepared in ap- (b) The additive meets the following propriate physical form and is derived specifications: by the polymerization of a grade of (1) The nitrogen content of the co- divinylbenzene which comprises at polymer is 9.4 to 10.8 weight percent on least 79 weight-percent divinylbenzene, a dry basis. 15 to 20 weight-percent ethylvinyl- (2) A 50-percent-by-weight aqueous benzene, and no more than 4 weight- solution of the copolymer has a min- percent nonpolymerizable impurities. imum viscosity of 175 centipoises at 25 (b) In accordance with the manufac- ° C as determined by LVT-series Brook- turer’s directions, the copolymer de- field viscometer using a No. 2 spindle scribed in paragraph (a) of this section at 60 RPM (or by another equivalent is subjected to pre-use extraction with method). a water soluble alcohol until the level (3) The additive contains not more of divinylbenzene in the extract is less than 1,000 parts per million of 1,3- than 50 parts per billion as determined dichloro-2-propanol and not more than by a method titled, ‘‘The Determina- 10 parts per million epichlorohydrin. tion of Divinylbenzene in Alcohol Ex- The epichlorohydrin and 1,3-dichloro-2- tracts of Amberlite XAD–4,’’ which is propanol content is determined by an incorporated by reference. Copies of analytical method entitled ‘‘The Deter- this method are available from the mination of Epichlorohydrin and 1,3- Center for Food Safety and Applied Nu- Dichloro-2-Propanol in Dimethyl- trition (HFS–200), Food and Drug Ad- amine-Epichlorohydrin Copolymer,’’ ministration, 200 C St. SW., Wash- which is incorporated by reference. ington, DC 20204, or available for in- Copies are available from the Center spection at the Office of the Federal for Food Safety and Applied Nutrition Register, 800 North Capitol Street, (HFS–200), Food and Drug Administra- NW., suite 700, Washington, DC 20408. tion, 200 C St. SW., Washington, DC The copolymer is then treated with 20204, or available for inspection at the water according to the manufacturer’s Office of the Federal Register, 800 recommendation to remove the extrac- North Capitol Street, NW., suite 700, tion solvent to guarantee a food-grade Washington, DC 20408. purity of the resin at the time of use, (4) Heavy metals (as Pb), 2 parts per in accordance with current good manu- million maximum. facturing practice. (5) Arsenic (as As), 2 parts per million (c) The temperature of the aqueous maximum. food stream contacting the polymer is (c) The food additive is used as a de- maintained at 79.4 °C (175 °F) or less. colorizing 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- polymer by weight of sugar solids. [50 FR 61, Jan. 2, 1985]
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§ 173.70 Chloromethylated aminated (1) A weight average molecular styrene-divinylbenzene resin. weight of 2,000 to 2,300; and (2) A weight average molecular Chloromethylated aminated styrene- weight to number average molecular divinylbenzene copolymer (CAS Reg. weight ratio of not more than 1.3. Cop- No. 60177–39–1) may be safely used in ies of the method are available from food in accordance with the following the Center for Food Safety and Applied prescribed conditions: Nutrition (HFS–200), Food and Drug (a) The additive is an aqueous disper- Administration, 200 C Street SW., sion of styrene-divinylbenzene copoly- Washington, DC 20204, or available for mers, first chloromethylated then inspection at the Office of the Federal aminated with trimethylamine, having Register, 800 North Capitol Street, an average particle size of not more NW., suite 700, Washington, DC 20408. than 2.0 microns. (b) The additive is used to control (b) The additive shall contain no mineral scale during the evaporation of more than 3.0 percent nonvolatile, beet sugar juice or cane sugar juice in soluble extractives when tested as fol- the production of sugar in an amount lows: One hundred grams of the addi- not to exceed 3.6 parts per million by tive is centrifuged at 17,000 r/min for 2 weight of the raw juice. hours. The resulting clear supernatant is removed from the compacted solids [53 FR 39456, Oct. 7, 1988; 53 FR 49823, Dec. 9, 1988] and concentrated to approximately 10 grams on a steam bath. The 10-gram § 173.75 Sorbitan monooleate. sample is again centrifuged at 17,000 r/ Sorbitan monooleate may be safely min for 2 hours to remove any residual used in accordance with the following insoluble material. The supernatant prescribed conditions: from the second centrifugation is then (a) The additive is produced by the removed from any compacted solids esterification of sorbitol with commer- and dried to constant residual weight cial oleic acid. using a steam bath. The percent non- (b) It meets the following specifica- volatile solubles is obtained by divid- tions: ing the weight of the dried residue by (1) Saponification number, 145–160. the weight of the solids in the original (2) Hydroxyl number, 193–210. resin dispersion. (c) The additive is used or intended (c) The additive is used as a decol- for use as follows: orizing and clarification agent for (1) As an emulsifier in polymer dis- treatment of refinery sugar liquors and persions that are used in the clarifica- juices at levels not to exceed 500 parts tion of cane or beet sugar juice or liq- of additive solids per million parts of uor in an amount not to exceed 7.5 per- sugar solids. cent by weight in the final polymer dis- [50 FR 29209, July 18, 1985] persion. (2) The additive is used in an amount § 173.73 Sodium polyacrylate. not to exceed 0.70 part per million in sugar juice and 1.4 parts per million in Sodium polyacrylate (CAS Reg. No. sugar liquor. 9003–04–7) may be safely used in food in accordance with the following pre- [51 FR 11720, Apr. 7, 1986] scribed conditions: (a) The additive is produced by the Subpart B—Enzyme Preparations polymerization of acrylic acid and sub- and Microorganisms sequent hydrolysis of the polyacrylic acid with an aqueous sodium hydroxide § 173.110 Amyloglucosidase derived solution. As determined by a method from Rhizopus niveus. entitled ‘‘Determination of Weight Av- Amyloglucosidase enzyme product, erage and Number Average Molecular consisting of enzyme derived from Weight of Sodium Polyacrylate,’’ Rhizopus niveus, and diatomaceous sili- which is incorporated by reference in ca as a carrier, may be safely used in accordance with 5 U.S.C. 552(a), the ad- food in accordance with the following ditive has— conditions:
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(a) Rhizopus niveus is classified as fol- Mucorales; family, Mucoraceae; genus, lows: Class, Phycomycetes; order, Rhizopus; species, Rhizopus oryzae. Mucorales; family, Mucoraceae; genus, (b) The strain of Rhizopus oryzae is Rhizopus; species, niveus. nonpathogenic and nontoxic. (b) The strain of Rhizopus niveus is (c) The carbohydrase is produced nonpathogenic and nontoxic in man or under controlled conditions to main- other animals. tain nonpathogenicity and nontoxicity, (c) The enzyme is produced by a proc- including the absence of aflatoxin. ess which completely removes the or- (d) The carbohydrase is produced by a ganism Rhizopus niveus from the process which completely removes the amyloglucosidase. organism Rhizopus oryzae from the (d) The additive is used or intended carbohydrase product. for use for degrading gelatinized starch (e) The carbohydrase is maintained into constituent sugars, in the produc- under refrigeration from production to tion of distilled spirits and vinegar. use and is labeled to include the neces- (e) The additive is used at a level not sity of refrigerated storage. to exceed 0.1 percent by weight of the gelatinized starch. § 173.135 Catalase derived from Micro- coccus lysodeikticus. § 173.120 Carbohydrase and cellulase Bacterial catalase derived from derived from Aspergillus niger. Micrococcus lysodeikticus by a pure cul- Carbohydrase and cellulase enzyme ture fermentation process may be safe- preparation derived from Aspergillus ly used in destroying and removing hy- niger may be safely used in food in ac- drogen peroxide used in the manufac- cordance with the following prescribed ture of cheese, in accordance with the conditions: following conditions. (a) Aspergillus niger is classified as (a) The organism Micrococcus follows: Class, Deuteromycetes; order, lysodeikticus from which the bacterial Moniliales; family, Moniliaceae; genus, catalase is to be derived is dem- Aspergillus; species, niger. onstrated 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: § 173.130 Carbohydrase derived from (a) Mucor miehei var. Cooney et Emer- Rhizopus oryzae. son is classified as follows: Class, Carbohydrase from Rhizopus oryzae Phycomycetes; subclass, Zygomycetes; may be safely used in the production of order, Mucorales; family, Mucoraceae; dextrose from starch in accordance genus, Mucor; species, miehei; variety with the following prescribed condi- Cooney et Emerson. tions: (b) The strain of Mucor miehei var. (a) Rhizopus oryzae is classified as fol- Cooney et Emerson is nonpathogenic and lows: Class, Phycomycetes; order, nontoxic in man or other animals.
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(c) The enzyme is produced by a proc- (d) The enzyme removal is such that ess which completely removes the or- there are no enzyme or mycelial resi- ganism Mucor miehei var. Cooney et dues remaining in the finished sucrose. 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). (e) The enzyme is used at levels not § 173.150 Milk-clotting enzymes, micro- to exceed current good manufacturing bial. practice in the following food cat- Milk-clotting enzyme produced by egories: cheeses as defined in pure-culture fermentation process may § 170.3(n)(5) of this chapter; fat and oils be safely used in the production of as defined in § 170.(3)(n)(12) of this chap- cheese in accordance with the fol- ter; and milk products as defined in lowing prescribed conditions: § 170.(3)(n)(31) of this chapter. Use of (a) Milk-clotting enzyme is derived this food ingredient is limited to from one of the following organisms by nonstandarized foods and those foods a pure-culture fermentation process: for which the relevant standards of (1) Endothia parasitica classified as identity permit such use. follows: Class, Ascomycetes; order, (f) The enzyme is used in the min- Sphaeriales; family, Diaporthacesae; imum amount required to produce its genus, Endothia; species, parasitica. limited technical effect. (2) Bacillus cereus classified as fol- lows: Class, Schizomycetes; order, [47 FR 28090, June 29, 1982; 48 FR 2748, Jan. 21, 1983] Eubacteriales; family, Bacillaceae; genus, Bacillus; species, cereus § 173.145 Alpha-Galactosidase derived (Frankland and Frankland). from Mortierella vinaceae var. (3) Mucor pusillus Lindt classified as raffinoseutilizer. follows: Class, Phycomycetes; subclass, The food additive alpha-galactosidase Zygomycetes; order, Mucorales; fam- and parent mycelial microorganism ily, Mucoraceae; genus, Mucor; species, Mortierella vinaceae var. raffinoseutilizer pusillus; variety, Lindt. may be safely used in food in accord- (4) Mucor miehei Cooney et Emerson ance with the following conditions: classified as follows: Class, (a) The food additive is the enzyme Phycomycetes; subclass, Zygomycetes; alpha-galactosidase and the mycelia of order, Mucorales; family, Mucoraceae; the microorganism Mortierella vinaceae genus, Mucor; species, miehei; variety, var. raffinoseutilizer which produces the Cooney et Emerson. enzyme. (5) Aspergillus oryzae modified by re- (b) The nonpathogenic microorga- combinant deoxyribonucleic (DNA) nism matches American Type Culture techniques to contain the gene coding Collection (ATCC) No. 20034,1 and is for aspartic proteinase from classified as follows: Rhizomucor miehei var. Cooney et Emer- son as defined in paragraph (a)(4) of Class: Phycomycetes. this section, and classified as follows: Order: Mucorales. Class, Blastodeuteromycetes Family: Mortierellaceae. (Hyphomycetes); order, Phialidales Genus: Mortierella. (Moniliales); genus, Aspergillus; species Species: vinaceae. Variety: raffinoseutilizer. oryzae. (b) The strains of organism identified (c) The additive is used or intended in paragraph (a) of this section are for use in the production of sugar (su- nonpathogenic and nontoxic in man or crose) from sugar beets by addition as other animals. mycelial pellets to the molasses to in- (c) The additive is produced by a crease the yield of sucrose, followed by process that completely removes the removal of the spent mycelial pellets generating organism from the milk- by filtration. clotting enzyme product. (d) The additive is used in an amount 1 Available from: American Type Culture not in excess of the minimum required Collection, 12301 Parklawn Drive, Rockville, to produce its intended effect in the MD 20852. production of those cheeses for which
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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 Codex,’’ 3d Ed. (1981), under ‘‘Citric [42 FR 14526, Mar. 15, 1977; 42 FR 56728, Oct. 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: [42 FR 14526, Mar. 15, 1977, as amended at 47 (a) The food additive is the enzyme FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, system of the viable organism Candida 1984; 54 FR 24897, June 12, 1989] guilliermondii and its concomitant me- tabolites produced during the fer- § 173.165 Candida lipolytica. mentation process. The food additive Candida lipolytica (b)(1) The nonpathogenic and may be safely used as the organism for nontoxicogenic organism descending fermentation production of citric acid from strain, American Type Culture in accordance with the following condi- Collection (ATCC) No. 20474,1 is classi- tions: fied as follows: (a) The food additive is the enzyme Class: Deuteromycetes. system of the organism Candida Order: Moniliales. lipolytica and its concimitant metabo- Family: Cryptococcaceae. lites produced during the fermentation Genus: Candida. process. Species: guilliermondii. (b)(1) The nonpathogenic organism is Variety: guilliermondii. classified as follows: (2) The toxonomic characteristics of Class: Deuteromycetes. the reference culture strain ATCC No. Order: Moniliales. 20474 agree in the essentials with the Family: Cryptococcaceae. standard description for Candida Genus: Candida. guilliermondii variety guilliermondii list- Species: lipolytica. ed in ‘‘The Yeasts—A Toxonomic (2) The taxonomic characteristics of Study;’’ 2d Ed. (1970), by Jacomina the culture agree in essential with the Lodder, which is incorporated by ref- standard description for Candida erence. Copies are available from the lipolytica variety lipolytica listed in Center for Food Safety and Applied Nu- ‘‘The Yeasts—A Toxonomic Study,’’ 2d trition (HFS–200), Food and Drug Ad- Ed. (1970), by Jacomina Lodder, which ministration, 200 C St. SW., Wash- is incorporated by reference. Copies are ington, DC 20204, or available for in- available from the Center for Food spection at the Office of the Federal Safety and Applied Nutrition (HFS– Register, 800 North Capitol Street, 200), Food and Drug Administration, NW., suite 700, Washington, DC 20408. 200 C St. SW., Washington, DC 20204, or (c)(1) The additive is used or intended available for inspection at the Office of for use as a pure culture in the fer- the Federal Register, 800 North Capitol mentation process for the production Street, NW., suite 700, Washington, DC of citric acid using an acceptable aque- 20408. ous carbohydrate substrate. (c) The additive is used or intended (2) The organism Candida for use as a pure culture in the fer- quilliermondii is made nonviable and is mentation process for the production completely removed from the citric of citric acid from purified normal acid during the recovery and purifi- alkanes. cation process. (d) The additive is so used that the citric acid produced conforms to the 1 Available from: American Type Culture specifications of the ‘‘Food Chemicals Collection, 12301 Parklawn Drive, Rockville, Codex,’’ 3d Ed. (1981), pp. 86–87, which is MD 20852. incorporated by reference. Copies may
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be obtained from the National Acad- Wavelength repeatability, ±0.2 nanometer. emy Press, 2101 Constitution Ave. NW., Wavelength accuracy, ±1.0 nanometer. Washington, DC 20418, or may be exam- The spectrophotometer is equipped with ined at the Office of the Federal Reg- matched 1 centimeter path length quartz ister, 800 North Capitol Street, NW., microcuvettes with 0.5-milliliter volume ca- suite 700, Wasington, DC 20408. The ad- pacity. 6. Vacuum oven, minimum inside dimen- ditive meets the following ultraviolet sions: 200 mm × 200 mm × 300 mm deep. absorbance limits when subjected to the analytical procedure described in REAGENTS AND MATERIALS this paragraph: Organic solvents. All solvents used through- Ultraviolet absorbance per centimeter path out the procedure shall meet the specifica- length Maximum tions and tests described in this specifica- tion. The methyl alcohol, isooctane, benzene, 280 to 289 millimicrons ...... 0.25 hexane and 1,2-dichloroethane designated in 290 to 299 millimicrons ...... 0.20 300 to 359 millimicrons ...... 0.13 the list following this paragraph shall pass 360 to 400 millimicrons ...... 0.03 the following test: The specified quantity of solvent is added to a 250-milliliter round bottom flask con- ANALYTICAL PROCEDURE FOR CITRIC ACID taining 0.5 milliliter of purified n-hexa- GENERAL INSTRUCTIONS decane and evaporated on the rotary evapo- rator at 45 °C to constant volume. Six milli- Because of the sensitivity of the test, the liters of purified isooctane are added to this possibility of errors arising from contamina- residue and evaporated under the same con- tion is great. It is of the greatest importance ditions as above for 5 minutes. Determine that all glassware be scrupulously cleaned to the absorbance of the residue compared to remove all organic matter such as oil, purified n-hexadecane as reference. The ab- grease, detergent residues, etc. Examine all sorbance of the solution of the solvent res- glassware including stoppers and stopcocks, idue shall not exceed 0.03 per centimeter under ultraviolet light to detect any residual path length between 280 and 299 nanometers fluorescent contamination. As a pre- and 0.01 per centimeter path length between cautionary measure it is recommended prac- 300 and 400 nanometers. tice to rinse all glassware with purified iso- Methyl alcohol, A.C.S. reagent grade. Use 100 octane immediately before use. No grease is milliliters for the test described in the pre- to be used on stopcocks or joints. Great care ceding paragraph. If necessary, methyl alco- to avoid contamination of citric acid sam- hol may be purified by distillation through a ples in handling is essential to assure ab- Virgreaux column discarding the first and sence of any extraneous material arising last ten percent of the distillate or other- from inadequate packaging. Because some of wise. the polynuclear hydrocarbons sought in this Benzene, spectrograde (Burdick and Jackson test are very susceptible to photo-oxidation, Laboratories, Inc., Muskegon, Mich., or equiva- the entire procedure is to be carried out lent). Use 80 milliliters for the test. If nec- under subdued light. essary, benzene may be purified by distilla- APPARATUS tion or otherwise. Isooctane (2,2,4-trimethylpentane). Use 100 1. Aluminum foil, oil free. milliliters for the test. If necessary, iso- 2. Separatory funnels, 500-milliliter capac- octane may be purified by passage through a ity, equipped with tetrafluoroethylene poly- column of activated silica gel, distillation or mer stopcocks. otherwise. 3. Chromatographic tubes: (a) 80-milli- Hexane, spectrograde (Burdick and Jackson meter ID × 900-millimeter length equipped Laboratories, Inc., Muskegon, Mich., or equiva- with tetrafluoroethylene polymer stopcock lent). Use 100 milliliters for the test. If nec- and course fritted disk; (b) 18-millimeter ID essary, hexane may be purified by distilla- × 300-millimeter length equipped with tetra- tion or otherwise. fluoroethylene polymer stopcock. 4. Rotary vacuum evaporator, Buchi or 1,2-Dichloroethane, spectrograde (Matheson, equivalent. Coleman and Bell, East Rutherford, N.J., or 5. Spectrophotometer—Spectral range 250– equivalent). Use 100 milliliters for the test. If 400 nanometers with spectral slit width of 2 necessary, 1,2-dichloroethane may be puri- nanometers or less; under instrument oper- fied by distillation or otherwise. ating conditions for these absorbance meas- ELUTING MIXTURES urements, the spectrophotometer shall also meet the following performance require- 1. 10 percent 1,2-dichloroethane in hexane. ments: Prepare by mixing the purified solvents in Absorbance repeatability, ±0.01 at 0.4 ab- the volume ratio of 1 part of 1,2- sorbance. dichloroethane to 9 parts of hexane.
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2. 40 percent benzene in hexane. Prepare by Allow the phases to separate for at least 5 mixing the purified solvents in the volume minutes. Draw off the lower aqueous layer ratio of 4 parts of benzene to 6 parts of into a second 500-milliliter separatory funnel hexane. and repeat the extraction with a second ali- n-Hexadecane, 99 percent olefin-free. Deter- quot of 50 milliliters of isooctane. After sep- mine the absorbance compared to isooctane aration of the layers, draw off and discard as reference. The absorbance per centimeter the water layer. Combine both isooctane ex- path length shall not exceed 0.00 in the range tracts in the funnel containing the first ex- of 280–400 nanometers. If necessary, n-hexa- tract. Rinse the funnel which contained the decane may be purified by percolation second extract with 10 milliliters of iso- through activated silica gel, distillation or octane and add this portion to the combined otherwise. isooctane extract. Silica gel, 28–200 mesh (Grade 12, Davison A chromatographic column containing 5.5 Chemical Co., Baltimore, MD, or equivalent). 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 mil- liters 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 1 milliliter. The absorbance of this residue umn until the solvent layer reaches the top shall not exceed 0.02 per centimeter path of the sodium sulfate bed. Discard the rinse length between 300–400 nanometers and 0.03 solvents. Place a 250-milliliter round bottom per centimeter path length between 280–299 flask containing 0.5 milliliter of purified n- nanometers. If necessary, water may be puri- hexadecane under the column. Elute the fied by distillation, extraction with purified polynuclear aromatic hydrocarbons from the organic solvents, treatment with an absorb- column with 30 milliliters of 40-percent ben- ent (e.g., activated carbon) followed by fil- zene in hexane solution. Drain the eluate tration of the absorbent or otherwise. until the 40-percent benzene in the hexane solvent reaches the top of the sodium sulfate PROCEDURE bed. Separate portions of 200 milliliters of puri- Evaporate the 40-percent benzene in fied water are taken through the procedure hexane eluate on the rotary vacuum evapo- for use as control blanks. Each citric acid rator at 45 °C until only the n-hexadecane sample is processed as follows: Weigh 200 residue of 0.5 milliliter remains. Treat the n- grams of anhydrous citric acid into a 500 mil- hexadecane residue twice with the following liliter flask and dissolve in 200 milliliters of wash step: Add 6 milliliters of purified iso- pure water. Heat the solution to 60 °C and octane and remove the solvents by vacuum transfer to a 500 milliliter separatory funnel. evaporation at 45 °C to constant volume, i.e., Rinse the flask with 50 milliliters of iso- 0.5 milliliter. Cool the n-hexadecane residue octane and add the isooctane to the sepa- and transfer the solution to an 0.5-milliliter ratory funnel. Gently shake the mixture 90 microcuvette. Determine the absorbance of times (caution: vigorous shaking will cause this solution compared to purified n-hexa- emulsions) with periodic release of the pres- decane as reference. Correct the absorbance sure caused by shaking. values for any absorbance derived from the
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control reagent blank. If the corrected ab- (a) The substance meets the fol- sorbance does not exceed the limits pre- lowing specifications: scribed, the samples meet the ultraviolet ab- (1) 1,3-Butylene glycol content: Not sorbance specifications. less than 99 percent. The reagent blank is prepared by using 200 ° milliliters of purified water in place of the (2) Specific gravity at 20/20 C: 1.004 citric acid solution and carrying the water to 1.006. sample through the procedure. The typical (3) Distillation range: 200°–215 °C. control reagent blank should not exceed 0.03 (b) It is used in the minimum amount absorbance per centimeter path length be- required to perform its intended effect. tween 280 and 299 nanometers, 0.02 absorb- (c) It is used as a solvent for natural ance per centimeter path length between 300 and synthetic flavoring substances ex- and 359 nanometers, and 0.01 absorbance per centimeter path length between 360 and 400 cept where standards of identity issued nanometers. under section 401 of the act preclude such use. [42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, § 173.228 Ethyl acetate. 1984; 54 FR 24897, June 12, 1989] Ethyl acetate (CAS Reg. No. 141–78–6) § 173.170 Aminoglycoside 3′-phospho- may be safely used in food in accord- transferase II. ance with the following conditions: The food additive aminoglycoside 3′- (a) The additive meets the specifica- phosphotransferase II may be safely tions of the Food Chemicals Codex, 1 used in the development of genetically (Ethyl Acetate; p. 372, 3d Ed., 1981), modified cotton, oilseed rape, and to- which are incorporated by reference. matoes in accordance with the fol- (b) The additive is used in accordance lowing prescribed conditions: with current good manufacturing prac- (a) The food additive is the enzyme tice as a solvent in the decaffeination aminoglycoside 3′-phosphotransferase of coffee and tea. II (CAS Reg. No. 58943–39–8) which cata- [47 FR 146, Jan. 5, 1982, as amended at 49 FR lyzes the phosphorylation of certain 28548, July 13, 1984] aminoglycoside antibiotics, including kanamycin, neomycin, and gentamicin. § 173.230 Ethylene dichloride. ′ (b) Aminoglycoside 3 -phosphotrans- A tolerance of 30 parts per million is ferase II is encoded by the kanr gene established for ethylene dichloride in originally isolated from transposon Tn5 spice oleoresins when present therein of the bacterium Escherichia coli. as a residue from the extraction of (c) The level of the additive does not spice; Provided, however, That if resi- exceed the amount reasonably required dues of other chlorinated solvents are for selection of plant cells carrying the also present the total of all residues of kanr gene along with the genetic mate- such solvents shall not exceed 30 parts rial of interest. per million. [59 FR 26711, May 23, 1994] § 173.240 Isopropyl alcohol. Subpart C—Solvents, Lubricants, Isopropyl alcohol may be present in Release Agents and Related the following foods under the condi- Substances tions specified: (a) In spice oleoresins as a residue § 173.210 Acetone. from the extraction of spice, at a level not to exceed 50 parts per million. A tolerance of 30 parts per million is (b) In lemon oil as a residue in pro- established for acetone in spice duction of the oil, at a level not to ex- oleoresins when present therein as a ceed 6 parts per million. residue from the extraction of spice.
§ 173.220 1,3-Butylene glycol. 1 Copies may be obtained from: National Academy Press, 2101 Constitution Ave. NW., 1,3-Butylene glycol (1,3-butanediol) Washington, DC 20418 or examined at the Of- may be safely used in food in accord- fice of the Federal Register, 800 North Cap- ance with the following prescribed con- itol Street, NW., suite 700, Washington, DC ditions: 20408.
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(c) In hops extract as a residue from percent) in decaffeinated roasted coffee the extraction of hops at a level not to and in decaffeinated soluble coffee ex- exceed 2.0 percent by weight: Provided, tract (instant coffee). That, (1) The hops extract is added to the § 173.270 Hexane. wort before or during cooking in the Hexane may be present in the fol- manufacture of beer. lowing foods under the conditions spec- (2) The label of the hops extract ified: specifies the presence of the isopropyl (a) In spice oleoresins as a residue alcohol and provides for the use of the from the extraction of spice, at a level hops extract only as prescribed by not to exceed 25 parts per million. paragraph (c)(1) of this section. (b) In hops extract as a residue from § 173.250 Methyl alcohol residues. the extraction of hops, at a level not to exceed 2.2 percent by weight; Provided, Methyl alcohol may be present in the That: following foods under the conditions (1) The hops extract is added to the specified: wort before or during cooking in the (a) In spice oleoresins as a residue manufacture of beer. from the extraction of spice, at a level (2) The label of the hops extract not to exceed 50 parts per million. 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 manufacture of beer. The food additive hydrogenated (2) The label of the hops extract sperm oil may be safely used in accord- specifies the presence of methyl alco- ance with the following prescribed con- hol and provides for the use of the hops ditions: extract only as prescribed by para- (a) The sperm oil is derived from ren- graph (b)(1) of this section. dering the fatty tissue of the sperm whale or is prepared by synthesis of § 173.255 Methylene chloride. fatty acids and fatty alcohols derived Methylene chloride may be present in from the sperm whale. The sperm oil food under the following conditions: obtained by rendering is refined. The (a) In spice oleoresins as a residue oil is hydrogenated. from the extraction of spice, at a level (b) It is used alone or as a component not to exceed 30 parts per million; Pro- of a release agent or lubricant in bak- vided, That, if residues of other ery pans. chlorinated solvents are also present, (c) The amount used does not exceed the total of all residues of such sol- that reasonably required to accomplish vents shall not exceed 30 parts per mil- the intended lubricating effect. lion. (b) In hops extract as a residue from § 173.280 Solvent extraction process the extraction of hops, at a level not to for citric acid. exceed 2.2 percent, Provided, That: A solvent extraction process for re- (1) The hops extract is added to the covery of citric acid from conventional wort before or during cooking in the Aspergillus niger fermentation liquor manufacture of beer. may be safely used to produce food- (2) The label of the hops extract iden- grade citric acid in accordance with tifies the presence of the methylene the following conditions: chloride and provides for the use of the (a) The solvent used in the process hops extract only as prescribed by consists of a mixture of n-octyl alcohol paragraph (b)(1) of this section. meeting the requirements of § 172.864 of (c) In coffee as a residue from its use this chapter, synthetic isoparaffinic as a solvent in the extraction of caf- petroleum hydrocarbons meeting the feine from green coffee beans, at a level requirements of § 172.882 of this chap- not to exceed 10 parts per million (0.001 ter, and tridodecyl amine.
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(b) The component substances are (a) The additive is generated by one used solely as a solvent mixture and in of the following methods: Treating an a manner that does not result in for- aqueous solution of sodium chlorite mation of products not present in con- with either chlorine gas or a mixture of ventionally produced citric acid. sodium hypochlorite and hydrochloric (c) The citric acid so produced meets acid, or treating an aqueous solution of the specifications of the ‘‘Food Chemi- sodium chlorate with hydrogen per- cals Codex,’’ 3d Ed. (1981), pp. 86–87, oxide in the presence of sulfuric acid. which is incorporated by reference In either case, the generator effluent (copies may be obtained from the Na- contains at least 90 percent (by weight) tional Academy Press, 2101 Constitu- of chlorine dioxide with respect to all tion Ave. NW., Washington, DC 20418, chlorine species as determined by or may be examined at the Office of the Method 4500–ClO2 E in the ‘‘Standard Federal Register, 800 North Capitol Methods for the Examination of Water Street, NW., suite 700, Washington, DC and Wastewater,’’ 18th ed., 1992, or an 20408), and the polynuclear aromatic equivalent method. Method 4500–ClO2 E hydrocarbon specifications of § 173.165. is incorporated by reference in accord- (d) Residues of n-octyl alcohol and ance with 5 U.S.C. 552(a) and 1 CFR synthetic isoparaffinic petroleum hy- part 51. Copies are available from the drocarbons are removed in accordance Center for Food Safety and Applied Nu- with good manufacturing practice. Cur- trition (HFS–200), Food and Drug Ad- rent good manufacturing practice re- ministration, 200 C St. SW., Wash- sults in residues not exceeding 16 parts ington, DC 20204–0001, and the Amer- per million (ppm) n-octyl alcohol and ican Public Health Association, 1015 0.47 ppm synthetic isoparaffinic petro- Fifteenth St. NW., Washington, DC leum hydrocarbons in citric acid. 20005, or may be examined at the Office (e) Tridodecyl amine may be present of the Federal Register, 800 North Cap- as a residue in citric acid at a level not itol St. NW., suite 700, Washington, DC. 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- ual chlorine dioxide as determined by § 173.290 Trichloroethylene. Method 4500–ClO2 E, referenced in para- Tolerances are established for resi- graph (a) of this section, or an equiva- dues of trichloroethylene resulting lent method. from its use as a solvent in the manu- (2) The additive may be used as an facture of foods as follows: antimicrobial agent in water used to Decaffeinated ground 25 parts per million. wash fruits and vegetables that are not coffee. raw agricultural commodities in an Decaffeinated soluble 10 parts per million. amount not to exceed 3 ppm residual (instant) coffee extract. chlorine dioxide as determined by Spice oleoresins ...... 30 parts per million (pro- vided that if residues Method 4500–ClO2 E, referenced in para- of other chlorinated graph (a) of this section, or an equiva- solvents are also lent method. Treatment of the fruits present, the total of all residues of such sol- and vegetables with chlorine dioxide vents in spice shall be followed by a potable water oleoresins shall not ex- rinse or by blanching, cooking, or can- ceed 30 parts per mil- ning. lion). [60 FR 11900, Mar. 3, 1995. Redesignated at 61 FR 14245, Apr. 1, 1996, as amended at 61 FR Subpart D—Specific Usage 14480, Apr. 2, 1996; 63 FR 38747, July 20, 1998; Additives 65 FR 34587, May 31, 2000]
§ 173.300 Chlorine dioxide. § 173.310 Boiler water additives. Chlorine dioxide (CAS Reg. No. 10049– Boiler water additives may be safely 04–4) may be safely used in food in ac- used in the preparation of steam that cordance with the following prescribed will contact food, under the following conditions: conditions:
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(a) The amount of additive is not in (b) The compounds are prepared from excess of that required for its func- substances identified in paragraphs (c) tional purpose, and the amount of and (d) of this section, and are subject steam in contact with food does not ex- to the limitations, if any, prescribed: ceed that required to produce the in- (c) List of substances: tended effect in or on the food.
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 (HFSÐ200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or may be examined at the Of- fice 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. 2809Ð21Ð4) 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 ethyl- ene 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. 71050Ð62Ð9), 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. 26099Ð09Ð2], and/or its sodium Total not to exceed 1 part per million in boiler feed water (cal- salt. [CAS Reg. No. 30915Ð61Ð8 or CAS Reg. No. 70247Ð culated as the acid). 90Ð4]. 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 max- imum 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. 744Ð745, 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 Nu- trition’s Library, Food and Drug Administration, 200 C St. SW., rm. 3321, Washington, DC, or at the Office of the Fed- eral Register, 800 North Capitol St. NW., suite 700, Wash- ington, DC. Sodium glucoheptonate...... Less than 1 part per million cyanide in the sodium glucoheptonate. Sodium hexametaphosphate. Sodium humate. Sodium hydroxide. Sodium lignosulfonate. Sodium metabisulfite. Sodium metasilicate. Sodium nitrate. Sodium phosphate (mono-, di-, tri-). Sodium polyacrylate. Sodium polymethacrylate. Sodium silicate. Sodium sulfate.
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Substances Limitations
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. 306Ð307, which is incorporated by reference in accord- ance 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, 200 C St. SW., rm. 3321, Washington, DC, 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, § 173.315 Chemicals used in washing in addition to the other information re- or to assist in the peeling of fruits quired by the Act, the label or labeling and vegetables. shall bear: Chemicals may be safely used to (1) The common or chemical name or wash or to assist in the peeling of names of the additive or additives. fruits and vegetables in accordance (2) Adequate directions for use to as- with the following conditions: sure compliance with all the provisions (a) The chemicals consist of one or of this section. more of the following: [42 FR 14526, Mar. 15, 1977, as amended at 45 (1) Substances generally recognized FR 73922, Nov. 7, 1980; 45 FR 85726, Dec. 30, as safe in food or covered by prior sanc- 1980; 48 FR 7439, Feb. 22, 1983; 49 FR 5748, Feb. tions for use in washing fruits and 15, 1984; 49 FR 10106, Mar. 19, 1984; 50 FR 49536, vegetables. Dec. 3, 1985; 53 FR 15199, Apr. 28, 1988; 54 FR 31012, July 26, 1989; 55 FR 12172, Apr. 2, 1990; (2) Substances identified in this sub- 61 FR 14245, Apr. 1, 1996; 64 FR 1759, Jan. 12, paragraph and subject to such limita- 1999; 64 FR 29227, June 1, 1999] tions as are provided:
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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: α-alkyl lye-peeling solution to assist in the lye peeling of (C12-C18)-omega-hydroxy-poly (oxyethylene) (7.5Ð8.5 moles)/poly fruit and vegetables. (oxypropylene) block copolymer having an average molecular weight of 810; α-alkyl (C12-C18)-omega-hydroxy-poly (oxyethylene) (3.3Ð3.7 moles) polymer having an average molecular weight of 380, and sub- sequently esterified with 1.25 moles phosphoric anhydride; and α-alkyl (C10-C12)-omega-hydroxypoly (oxyethylene) (11.9Ð12.9 moles)/poly (oxypropylene) copolymer, having an average molecular weight of 810, and subsequently esterified with 1.25 moles phosphoric anhy- dride. 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. 245Ð260) 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- (5) Substances identified in this para- thalene sulfonates (mol. wt. 245–260) graph (a)(5) for use on fruits and vege- may be used in the steam/scald vacuum tables that are not raw agricultural peeling of tomatoes at a level not to commodities and subject to the limita- exceed 0.2 percent in the condensate or tions provided: scald water. (4) Substances identified in this para- graph (a)(4) for use in flume water for washing sugar beets prior to the slicing Substances Limitations operation and subject to the limita- Hydrogen peroxide ...... Used in combination with acetic tions as are provided for the level of acid to form peroxyacetic acid. the substances in the flume water: Not to exceed 59 ppm in wash water. Substance Limitations 1-Hydroxyethylidene-1,1- May be used only with peroxy- diphosphonic acid. acetic acid. Not to exceed 4.8 α-Alkyl-omega-hydroxypoly-(oxy- Not to exceed 3 ppm. ppm in wash water. ethylene) produced by con- Peroxyacetic acid ...... Prepared by reacting acetic acid densation of 1 mole of C11- with hydrogen peroxide. Not to C486315 straight chain ran- exceed 80 ppm in wash water. domly substituted secondary al- cohols with an average of 9 moles of ethylene oxide. (b) The chemicals are used in Linear undecylbenzenesulfonic Do. amounts not in excess of the minimum acid. required to accomplish their intended Dialkanolamide produced by con- Not to exceed 2 ppm. effect. densing 1 mole of methyl lau- rate with 1.05 moles of (c) The use of the chemicals listed diethanolamine. under paragraphs (a)(1), (a)(2), and Triethanolamine ...... Do. (a)(4) is followed by rinsing with pota- Ethylene glycol monobutyl ether .. Not to exceed 1 ppm. Oleic acid conforming with Do. ble water to remove, to the extent pos- ¤ 172.860 of this chapter. sible, residues of the chemicals. Tetrapotassium pyrophosphate .... Not to exceed 0.3 ppm. Monoethanolamine ...... Do. (d) To assure safe use of the additive: Ethylene dichloride ...... Not to exceed 0.2 ppm. (1) The label and labeling of the addi- Tetrasodium ethylenediamine- Not to exceed 0.1 ppm. tive container shall bear, in addition to tetraacetate. the other information required by the
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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- tive container shall bear adequate use Parts per million directions to assure use in compliance 2,2-Dibromo-3-nitrilopropionamide (CAS Not more than with all provisions of this section. Reg. No. 10222Ð01Ð2). 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- FR 29856, June 10, 1977; 42 FR 32229, June 24, nitrilopropionamide are not authorized 1977; 43 FR 54926, Nov. 24, 1978; 61 FR 46376, for use in animal feed. 46377, Sept. 3, 1996; 63 FR 7069, Feb. 12, 1998; 64 FR 38564, July 19, 1999] (5) Combination for cane-sugar mills:
§ 173.320 Chemicals for controlling Parts per mil- microorganisms in cane-sugar and lion beet-sugar mills. n-Dodecyl dimethyl benzyl ammonium chlo- Agents for controlling microorga- ride ...... 0.05±0.005 nisms in cane-sugar and beet-sugar n-Dodecyl dimethyl ethylbenzyl ammonium chloride ...... 0.68±0.068 mills may be safely used in accordance n-Hexadecyl dimethyl benzyl ammonium with the following conditions: chloride ...... 0.30±0.030 (a) They are used in the control of n-Octadecyl dimethyl benzyl ammonium microorganisms in cane-sugar and/or chloride ...... 0.05±0.005 n-Tetradecyl dimethyl benzyl ammonium beet-sugar mills as specified in para- chloride ...... 0.60±0.060 graph (b) of this section. n-Tetradecyl dimethyl ethylbenzyl ammo- (b) They are applied to the sugar mill nium chloride ...... 0.32±0.032 grinding, crusher, and/or diffuser sys- tems in one of the combinations listed Limitations. Byproduct molasses, ba- in paragraph (b) (1), (2), (3), or (5) of gasse, and pulp containing residues of this section or as a single agent listed these quaternary ammonium salts are in paragraph (b) (4) or (6) of this sec- not authorized for use in animal feed. tion. Quantities of the individual addi- (6) Single additive for beet-sugar tives in parts per million are expressed mills: in terms of the weight of the raw cane or raw beets. Parts per million (1) Combination for cane-sugar mills: Glutaraldehyde (CAS Reg. No. Not more than 250. 111Ð30Ð8). Parts per mil- lion (c) To assure safe use of the addi- Disodium cyanodithioimidocarbonate ...... 2.5 tives, their label and labeling shall Ethylenediamine ...... 1.0 conform to that registered with the Potassium N-methyldithiocarbamate ...... 3.5 Environmental Protection Agency. (2) Combination for cane-sugar mills: [42 FR 14526, Mar. 15, 1977, as amended at 47 FR 35756, Aug. 17, 1982; 50 FR 3891, Jan. 29, Parts 1985; 57 FR 8065, Mar. 6, 1992] per mil- lion § 173.322 Chemicals used in delinting Disodium ethylenebisdithiocarbamate ...... 3.0 cottonseed. Sodium dimethyldithiocarbamate ...... 3.0 Chemicals may be safely used to as- (3) Combinations for cane-sugar mills sist in the delinting of cottonseed in and beet-sugar mills: accordance with the following condi- tions: Parts (a) The chemicals consist of one or per mil- lion more of the following: (1) Substances generally recognized (i) Disodium ethylenebisdithiocarbamate ...... 3.0 Ethylenediamine ...... 2.0 as safe for direct addition to food. Sodium dimethyldithiocarbamate ...... 3.0 (2) Substances identified in this para- (ii) Disodium cyanodithioimidocarbonate ...... 2.9 graph and subject to such limitations Potassium N-methyldithiocarbamate ...... 4.1 as are provided:
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Substances Limitations levels sufficient to achieve a solution pH of 2.8 to 3.2. alpha-Alkyl-omega- May be used at an applica- hydroxypoly-(oxyethylene) tion rate not to exceed 0.3 (c) The additive is used as an anti- produced by condensation percent by weight of cot- microbial agent in accordance with of a linear primary alcohol tonseeds to enhance current industry practice in the proc- containing an average delinting of cottonseeds in- chain length of 10 carbons tended for the production essing of red meat, red meat parts, and with poly(oxyethylene) hav- of cottonseed oil. Byprod- organs as a component of a spray or in ing an average of 5 ethyl- ucts including lint, hulls, the processing of red meat parts and ene oxide units. and meal may be used in animal feed. organs as a component of a dip. Applied An alkanomide produced by May be used at an applica- as a dip or spray, the additive is used condensation of coconut oil tion rate not to exceed 0.2 at levels that result in sodium chlorite fatty acids and dietha- percent by weight of cot- nolamine, CAS Reg. No. tonseeds to enhance concentrations between 500 and 1,200 068603Ð42Ð9. delinting of cottonseeds in- ppm in combination with any GRAS tended for the production acid at levels sufficient to achieve a so- of cottonseed oil. Byprod- lution pH of 2.5 to 2.9. ucts including lint, hulls, and meal may be used in (d) The additive is used as an anti- animal feed. microbial agent in water and ice that are used to rinse, wash, thaw, trans- [47 FR 8346, Feb. 26, 1982] port, or store seafood in accordance with current industry standards of § 173.325 Acidified sodium chlorite so- good manufacturing practice. The addi- lutions. tive is produced by mixing an aqueous Acidified sodium chlorite solutions solution of sodium chlorite with any may be safely used in accordance with GRAS acid to achieve a pH in the range the following prescribed conditions: of 2.5 to 2.9 and diluting this solution (a) The additive is produced by mix- with water to achieve an actual use ing an aqueous solution of sodium chlo- concentration of 40 to 50 parts per mil- rite (CAS Reg. No. 7758–19–2) with any lion (ppm) sodium chlorite. Any sea- generally recognized as safe (GRAS) food that is intended to be consumed acid. raw shall be subjected to a potable (b)(1) The additive is used as an anti- water rinse prior to consumption. microbial agent in poultry processing (e) The additive is used as an anti- water in accordance with current in- microbial agent on raw agricultural dustry practice under the following commodities in the preparing, packing, conditions: or holding of the food for commercial (i) As a component of a carcass spray purposes, consistent with section or dip solution prior to immersion of 201(q)(1)(B)(i) of the act, and not ap- the intact carcass in a prechiller or plied for use under section chiller tank; 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (ii) In a prechiller or chiller solution for application to the intact carcass; (q)(1)(B)(i)(III) of the act, in accordance (iii) As a component of a spray or dip with current industry standards of solution for application to poultry car- good manufacturing practice. Applied cass parts; or as a dip or a spray, the additive is used (iv) In a prechiller or chiller solution at levels that result in chlorite con- for application to poultry carcass centrations of 500 to 1200 parts per mil- parts. lion (ppm), in combination with any (2) When used in a spray or dip solu- GRAS acid at levels sufficient to tion, the additive is used at levels that achieve a pH of 2.3 to 2.9. Treatment of result in sodium chlorite concentra- the raw agricultural commodities with tions between 500 and 1,200 parts per acidified sodium chlorite solutions million (ppm), in combination with any shall be followed by a potable water GRAS acid at a level sufficient to rinse, or by blanching, cooking, or can- achieve a solution pH of 2.3 to 2.9. ning. (3) When used in a prechiller or chill- (f) The concentration of sodium chlo- er solution, the additive is used at lev- rite is determined by a method entitled els that result in sodium chlorite con- ‘‘Determination of Sodium Chlorite: 50 centrations between 50 and 150 ppm, in ppm to 1500 ppm Concentration,’’ Sep- combination with any GRAS acid at tember 13, 1995, developed by Alcide
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Corp., Redmond, WA, which is incor- § 173.340 Defoaming agents. porated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Defoaming agents may be safely used Copies are available from the Division in processing foods, in accordance with of Petition Control (HFS–215), Center the following conditions: for Food Safety and Applied Nutrition, (a) They consist of one or more of the Food and Drug Administration, 200 C following: St. SW., Washington, DC 20204–0001, or (1) Substances generally recognized may be examined at the Center for by qualified experts as safe in food or Food Safety and Applied Nutrition’s covered by prior sanctions for the use Library, 200 C St. SW., rm. 3321, Wash- prescribed by this section. ington, DC 20204–0001, or the Office of (2) Substances listed in this para- the Federal Register, 800 North Capitol graph (a)(2) of this section, subject to St. NW., Suite 700, Washington, DC. any limitations imposed: [61 FR 17829, Apr. 23, 1996, as amended at 63 FR 11119, Mar. 6, 1998; 64 FR 44123, Aug. 13, 1999; 64 FR 49982, Sept. 15, 1999; 65 FR 1776, Jan. 12, 2000; 65 FR 16312, Mar. 28, 2000]
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 1.400Ð1.404 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 per- cent of the dimethylpolysiloxane content. α-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. 9003Ð11Ð6) 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 paragraph (a)(3), provided they are components of defoaming agents limited to use in processing beet sugar and yeast, and subject to any limitations imposed:
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 hy- drocarbons.
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Substances Limitations
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, 1,200Ð3,000. 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.
(4) The substances listed in this para- Substances Limitations graph (a)(4), provided they are compo- Monoester of alpha-hydro- nents of defoaming agents limited to omega-hydroxy- use in processing beet sugar only, and poly(oxyethylene) subject to the limitations imposed: poly(oxypropylene) poly(oxyethylene) (15 mole minimum) blocked copoly- Substances Limitations mer derived from low eru- cic acid rapeseed oil. n-Butoxypoly(oxyethylene)- Viscosity range, 4,850Ð5,350 poly(oxypropylene)glycol. Saybolt Universal Seconds (SUS) at 37.8 °C (100 °F). (b) They are added in an amount not The viscosity range is de- in excess of that reasonably required to termined by the method ‘‘Viscosity Determination of inhibit foaming. n-butoxypoly(oxyethylene)- poly(oxypropylene) glycol’’ [42 FR 14526, Mar. 15, 1977, as amended at 43 dated April 26, 1995, de- FR 2872, Jan. 20, 1978; 46 FR 30493, June 9, veloped by Union Carbide 1981; 46 FR 57476, Nov. 24, 1981; 60 FR 54036, Corp., P.O. Box 670, Oct. 19, 1995; 61 FR 632, Jan. 9, 1996; 63 FR Bound Brook, NJ 08805, 29134, May 28, 1998] which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 § 173.342 Chlorofluorocarbon 113 and CFR part 51. Copies of the perfluorohexane. material incorporated by reference are available A mixture of 99 percent from the Division of Petition chlorofluorocarbon 113 (1,1,2-trichloro- Control, Center for Food 1,2,2-trifluoroethane) (CAS Reg. No. 76– Safety and Applied Nutri- tion (HFSÐ215), Food and 13–1, also known as fluorocarbon 113, Drug Administration, 200 C CFC 113 and FC 113) and 1 percent St. SW., Washington, DC 20204, and may be exam- perfluorohexane (CAS Reg. No. 355–42– ined at the Center for Food 0) may be safely used in accordance Safety and Applied Nutri- with the following prescribed condi- tion’s Library, 200 C St. SW., rm. 3321, Wash- tions: ington, DC, or at the Office (a) The additive chlorofluorocarbon of the Federal Register, 113 has a purity of not less than 99.99 800 North Capitol St. NW., suite 700, Washington, DC. percent. (b) The additive mixture is intended for use to quickly cool or crust-freeze chickens sealed in intact bags com- posed of substances regulated in parts 174, 175, 177, 178, and § 179.45 of this
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chapter and conforming to any limita- vided with an absorption-type filter ca- tions or specifications in such regula- pable of removing possible toxic impu- tions. rities, through which all gas used in the treatment of food shall pass; and [55 FR 8913, Mar. 9, 1990] with suitable controls to insure that § 173.345 Chloropentafluoroethane. any combustion products failing to meet the specifications provided in this The food additive section will be prevented from reaching chloropentafluoroethane may be safely the food being treated. used in food in accordance with the fol- (b) The food additive meets the fol- lowing prescribed conditions: lowing specifications: (a) The food additive has a purity of (1) Carbon monoxide content not to not less than 99.97 percent, and con- exceed 4.5 percent by volume. tains not more than 200 parts per mil- (2) The ultraviolet absorbance in iso- lion saturated fluoro compounds and 10 octane solution in the range 255 milli- parts per million unsaturated fluoro microns to 310 millimicrons not to ex- compounds as impurities. ceed one-third of the standard ref- (b) The additive is used or intended erence absorbance when tested as de- for use alone or with one or more of the scribed in paragraph (e) of this section. following substances: Carbon dioxide, (c) It is used or intended for use to nitrous oxide, propane, and displace or remove oxygen in the proc- octafluorocyclobutane complying with essing, storage, or packaging of bev- § 173.360, as an aerating agent for erage products and other food, except foamed or sprayed food products, with fresh meats. any propellant effect being incidental (d) To assure safe use of the additive and no more than is minimally nec- in addition to the other information re- essary to achieve the aerating func- quired by the act, the label or labeling tion, except that use is not permitted of the combustion device shall bear for those standardized foods that do adequate directions for use to provide a not provide for such use. combustion product gas that complies (c) To assure safe use of the additive with the limitations prescribed in para- (1) The label of the food additive con- graph (b) of this section, including in- tainer shall bear, in addition to the structions to assure proper filtration. other information required by the act, (e) The food additive is tested for the following: compliance with paragraph (b)(2) by (i) The name of the additive, the following empirical method: chloropentafluoroethane. Spectrophotometric measurements. All meas- (ii) The percentage of the additive urements are made in an ultraviolet spectro- present in the case of a mixture. photometer in optical cells of 5 centimeters (iii) The designation ‘‘food grade’’. in length, and in the range of 255 milli- (2) The label or labeling of the food microns to 310 millimicrons, under the same additive container shall bear adequate instrumental conditions. The standard ref- directions for use. erence absorbance is the absorbance at 275 millimicrons of a standard reference solution [42 FR 14526, Mar. 15, 1977, as amended at 43 of naphthalene (National Bureau of Stand- FR 11317, Mar. 17, 1978; 43 FR 14644, Apr. 7, ards Material No. 577 or equivalent in purity) 1978] containing a concentration of 1.4 milligrams per liter in purified isooctane, measured § 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
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untreated solvent as measured in a 5-centi- absorption vessel to 60 milliliters, and mix. meter cell. If necessary to obtain the pre- Determine the absorbance of the solution in scribed purities, the isooctane may be passed the 5-centimeter cell in the range 255 milli- through activated silica gel. microns to 310 millimicrons, inclusive, com- Apparatus. To assure reproducible results, pared to isooctane. The absorbance of the so- the additive is passed into the isooctane so- lution of combustion product gas shall not lution through a gas-absorption train con- exceed that of the isooctane solvent at any sisting of the following components and nec- wavelength in the specified range by more essary connections: than one-third of the standard reference ab- 1. A gas flow meter with a range up to 30 sorbance. liters per hour provided with a constant dif- ferential relay or other device to maintain a § 173.355 Dichlorodifluoromethane. constant flow rate independent of the input pressure. The food additive dichlorodi- 2. An absorption apparatus consisting of an fluoromethane may be safely used in inlet gas dispersion tube inserted to the bot- food in accordance with the following tom of a covered cylindrical vessel with a prescribed conditions: suitable outlet on the vessel for effluent gas. (a) The additive has a purity of not The dimensions and arrangement of tube and less than 99.97 percent. vessel are such that the inlet tube introduces (b) It is used or intended for use, in 1 the gas at a point not above 5 ⁄4 inches below accordance with good manufacturing the surface of the solvent through a sintered glass outlet. The dimensions of the vessel are practice, as a direct-contact freezing such, and both inlet and vessel are so de- agent for foods. signed, that the gas can be bubbled through (c) To assure safe use of the additive: 60 milliliters of isooctane solvent at a rate (1) The label of its container shall up to 30 liters per hour without mechanical bear, in addition to the other informa- loss of solvent. The level corresponding to 60 tion required by the act, the following: milliliters should be marked on the vessel. (i) The name of the additive, dichlo- 3. A cooling bath containing crushed ice rodifluoromethane, with or without the and water to permit immersion of the ab- sorption vessel at least to the solvent level parenthetical name ‘‘Food Freezant mark. 12’’. Caution. The various parts of the absorp- (ii) The designation ‘‘food grade’’. tion train must be connected by gas-tight (2) The label or labeling of the food tubing and joints composed of materials additive container shall bear adequate which will neither remove components from directions for use. nor add components to the gas stream. The gas source is connected in series to the flow- § 173.357 Materials used as fixing rate device, the flow meter, and the absorp- agents in the immobilization of en- tion apparatus in that order. Ventilation zyme preparations. should be provided for the effluent gases which may contain carbon monoxide. Fixing agents may be safely used in Sampling procedure. Immerse the gas-ab- the immobilization of enzyme prepara- sorption apparatus containing 60 milliliters tions in accordance with the following of isooctane in the coolant bath so that the conditions: solvent is completely immersed. Cool for at (a) The materials consist of one or least 15 minutes and then pass 120 liters of more of the following: the test gas through the absorption train at (1) Substances generally recognized a rate of 30 liters per hour or less. Maintain the coolant bath at 0 °C throughout. Remove as safe in food. the absorption vessel from the bath, dis- (2) Substances identified in this sub- connect, and warm to room temperature. paragraph and subject to such limita- Add isooctane to bring the contents of the tions as are provided:
Substances Limitations
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 en- zyme preparations for use in the manufacture of high fructose corn syrup, in ac- cordance with ¤ 184.1372 of this chapter. Glutaraldehyde ...... Do. Periodic acid (CAS Reg. No. 10450Ð60Ð 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. 68130Ð97Ð2) 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 (HFSÐ200), 200 C Nutrition (HFSÐ215), 200 C St. SW., Washington, DC 20204, or may be exam- St. SW., Washington, DC 20204, and ined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., may be examined at the Center for rm. 3321, Washington, DC, or the Office of the Federal Register, 800 North Cap- Food Safety and Applied Nutrition’s Li- itol St. NW., suite 700, Washington, DC. brary, 200 C St. SW., rm. 3321, Wash- ington, DC, or at the Office of the Fed- eral Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(b) The fixed enzyme preparation is (ii) The percentage of the additive washed to remove residues of the fixing present in the case of a mixture. materials. (iii) The designation ‘‘food grade’’. [48 FR 5716, Feb. 8, 1983, as amended at 52 FR (2) The label or labeling of the food 39512, Oct. 22, 1987; 55 FR 12172, Apr. 2, 1990; additive container shall bear adequate 59 FR 36937, July 20, 1994; 61 FR 4873, Feb. 9, directions for use. 1996; 61 FR 14245, Apr. 1, 1996] § 173.370 Peroxyacids. § 173.360 Octafluorocyclobutane. Peroxyacids may be safely used in ac- The food additive octafluorocyclo-bu- cordance with the following prescribed tane may be safely used as a propellant conditions: and aerating agent in foamed or (a) The additive is a mixture of per- sprayed food products in accordance oxyacetic acid, octanoic acid, acetic with the following conditions: acid, hydrogen peroxide, (a) The food additive meets the fol- peroxyoctanoic acid, and 1- lowing specifications: hydroxyethylidene-1,1-diphosphonic acid. 99.99 percent octafluorocyclobutane. (b) The additive is used as an anti- Less than 0.1 part per million fluoroolefins, calculated as perfluoroisobutylene. microbial agent on red meat carcasses in accordance with current industry (b) The additive is used or intended practice where the maximum con- for use alone or with one or more of the centration of peroxyacids is 220 parts following substances: Carbon dioxide, per million (ppm) as peroxyacetic acid nitrous oxide, and propane, as a propel- and the maximum concentration of hy- lant and aerating agent for foamed or drogen peroxide is 75 ppm. sprayed food products, except for those (c) The concentrations of peroxyacids standardized foods that do not provide and hydrogen peroxide in the additive for such use. are determined by a method entitled (c) To assure safe use of the additive: ‘‘Hydrogen Peroxide and Peracid (as (1) The label of the food additive con- Peracetic Acid) Content,’’ dated July tainer shall bear, in addition to the 26, 2000, developed by Ecolab, Inc., other information required by the act, which is incorporated by reference. The the following: Director of the Office of the Federal (i) The name of the additive, Register approves this incorporation octafluorocyclobutane. by reference in accordance with 5
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U.S.C. 552(a) and 1 CFR part 51. You (d) No residual catalyst may remain may obtain copies of this method from in the product at a detection limit of the Division of Petition Control (HFS– 0.2 part per million fluoride as deter- 215), Center for Food Safety and Ap- mined by the method described in ‘‘Of- plied Nutrition, Food and Drug Admin- ficial Methods of Analysis of the Asso- istration, 200 C St. SW., Washington, ciation of Official Analytical Chem- DC 20204–0001, or you may examine a ists,’’ sections 25.049–25.055, 13th Ed. copy at the Center for Food Safety and (1980), which is incorporated by ref- Applied Nutrition’s Library, 200 C St. erence. Copies may be obtained from SW., rm. 3321, Washington, DC, or at the Association of Official Analytical the Office of the Federal Register, 800 Chemists International, 481 North North Capitol St. NW., suite 700, Wash- Frederick Ave., suite 500, Gaithersburg, ington, DC. MD 20877–2504, or may be examined at [65 FR 70660, Nov. 27, 2000] the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, § 173.385 Sodium methyl sulfate. Washington, DC 20408. Sodium methyl sulfate may be [43 FR 54237, Nov. 11, 1978, as amended at 49 present in pectin in accordance with FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, the following conditions. 1989] (a) It is present as the result of methylation of pectin by sulfuric acid § 173.400 Dimethyldialkylammonium chloride. and methyl alcohol and subsequent treatment with sodium bicarbonate. Dimethyldialkylammonium chloride (b) It does not exceed 0.1 percent by may be safely used in food in accord- weight of the pectin. ance with the following prescribed con- ditions: § 173.395 Trifluoromethane sulfonic (a) The food additive is produced by acid. one of the following methods: Trifluoromethane sulfonic acid has (1) Ammonolysis of natural tallow the empirical formula CF 3 SO 3 H (CAS fatty acids to form amines that are Reg. No. 1493–13–6). The catalyst subsequently reacted with methyl chlo- (Trifluoromethane sulfonic acid) may ride to form the quaternary ammonium safely be used in the production of compounds consisting primarily of cocoa butter substitute from palm oil dimethyldioctadecylammonium chlo- (1-palmitoyl-2-oleoyl-3-stearin) (see ride and dimethyldihexadecyl- § 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. (2) Ammonolysis of natural tallow Appearance, Clear liquid. fatty acids to form amines that are Color, Colorless to amber. 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 the quaternary ammonium compound maximum. known as dimethyl(2-ethylhexyl) hy- Arsenic (as As), 3 parts per million max- drogenated tallow ammonium chloride imum. and consisting primarily of dimethyl(2- (b) It is used at levels not to exceed ethylhexyl)octadecylammonium chlo- 0.2 percent of the reaction mixture to ride and dimethyl(2-ethyl- catalyze the directed esterification. hexyl)hexadecylammonium chloride. (c) The esterification reaction is (b) The food additive described in quenched with steam and water and paragraph (a)(1) of this section con- the catalyst is removed with the aque- tains not more than a total of 2 percent ous phase. Final traces of catalyst are by weight of free amine and amine hy- removed by washing batches of the drochloride. The food additive de- product three times with an aqueous scribed in paragraph (a)(2) of this sec- solution of 0.5 percent sodium bicar- tion contains not more than 3 percent bonate. by weight, each, of free amine and
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amine hydrochloride as determined by Drug, and Cosmetic Act, adequate di- A.O.C.S. method Te 3a–64, ‘‘Acid Value rections to assure use in compliance and Free Amine Value of Fatty Quater- with paragraph (c) of this section. nary Ammonium Chlorides,’’ 2d print- [56 FR 42686, Aug. 29, 1991] ing including additions and revisions 1990, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 PART 174—INDIRECT FOOD CFR part 51. Copies are available from ADDITIVES: GENERAL the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Sec. Administration, 200 C St. SW., Wash- 174.5 General provisions applicable to indi- rect food additives. ington, DC 20204, and from the Amer- 174.6 Threshold of regulation for substances ican Oil Chemists’ Society, P.O. Box used in food–contact articles. 5037, Station A, Champaign, IL 61820, or AUTHORITY: 21 U.S.C. 321, 342, 348, 371. available for inspection at the Office of the Federal Register, 800 North Capitol § 174.5 General provisions applicable Street, NW., suite 700, Washington, DC. to indirect food additives. (c) The food additive is used as a de- (a) Regulations prescribing condi- colorizing agent in the clarification of tions under which food additive sub- refinery sugar liquors under the fol- stances may be safely used predicate lowing limitations: usage under conditions of good manu- (1) The food additive described in facturing practice. For the purpose of paragraph (a)(1) of this section is added this part and parts 175, 176, and 177 of only at the defecation/clarification this chapter, good manufacturing prac- stage of sugar liquor refining in an tice shall be defined to include the fol- amount not to exceed 700 parts per mil- lowing restrictions: lion by weight of sugar solids. (1) The quantity of any food additive (2) The food additive described in substance that may be added to food as paragraph (a)(2) of this section is used a result of use in articles that contact under the following conditions: food shall not exceed, where no limits (i) The additive is adsorbed onto a are specified, that which results from support column composed of suitable use of the substance in an amount not 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- (2) Any substance used as a compo- mination of Residual Quaternary Am- nent of articles that contact food shall monium Compounds (Arquad HTL8) in be of a purity suitable for its intended Sugar and Sugar Solutions,’’ June 13, use. 1990, which is incorporated by reference (b) The existence in the subchapter B in accordance with 5 U.S.C. 552(a) and 1 of a regulation prescribing safe condi- CFR part 51. Copies are available from tions for the use of a substance as an the Center for Food Safety and Applied article or component of articles that Nutrition (HFS–200), Food and Drug contact food shall not be construed to Administration, 200 C St. SW., Wash- relieve such use of the substance or ar- ington, DC 20204, or available for in- ticle from compliance with any other spection at the Office of the Federal provision of the Federal Food, Drug, Register, 800 North Capitol Street, and Cosmetic Act. For example, if a NW., suite 700, Washington, DC. regulated food-packaging material (d) To assure safe use of the additive, were found on appropriate test to im- the label and labeling of the additive part odor or taste to a specific food shall bear, in addition to other infor- product such as to render it unfit with- mation required by the Federal Food, in the meaning of section 402(a)(3) of
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the Act, the regulation would not be Subpart C—Substances for Use as construed to relieve such use from Components of Coatings compliance with section 402(a)(3). (c) The existence in this subchapter B 175.210 Acrylate ester copolymer coating. 175.230 Hot-melt strippable food coatings. of a regulation prescribing safe condi- 175.250 Paraffin (synthetic). tions for the use of a substance as an 175.260 Partial phosphoric acid esters of pol- article or component of articles that yester resins. contact food shall not be construed as 175.270 Poly(vinyl fluoride) resins. implying that such substance may be 175.300 Resinous and polymeric coatings. safely used as a direct additive in food. 175.320 Resinous and polymeric coatings for (d) Substances that under conditions polyolefin films. of good manufacturing practice may be 175.350 Vinyl acetate/crotonic acid copoly- safely used as components of articles mer. that contact food include the fol- 175.360 Vinylidene chloride copolymer coat- lowing, subject to any prescribed limi- ings for nylon film. 175.365 Vinylidene chloride copolymer coat- tations: ings for polycarbonate film. (1) Substances generally recognized 175.380 Xylene-formaldehyde resins con- as safe in or on food. densed with 4,4′-isopropylidenediphenol- (2) Substances generally recognized epichlorohydrin epoxy resins. as safe for their intended use in food 175.390 Zinc-silicon dioxide matrix coatings. packaging. AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. (3) Substances used in accordance with a prior sanction or approval. SOURCE: 42 FR 14534, Mar. 15, 1977, unless otherwise noted. (4) Substances permitted for use by regulations in this part and parts 175, EDITORIAL NOTE: Nomenclature changes to 176, 177, 178 and § 179.45 of this chapter. part 175 appear at 61 FR 14482, Apr. 2, 1996. [42 FR 14534, Mar. 15, 1977] 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 arti- cles (e.g., food-packaging or food-proc- § 175.105 Adhesives. essing equipment) that migrate, or (a) Adhesives may be safely used as that may be expected to migrate, into components of articles intended for use food at negligible levels may be re- in packaging, transporting, or holding viewed under § 170.39 of this chapter. food in accordance with the following The Food and Drug Administration prescribed conditions: will exempt substances whose uses it (1) The adhesive is prepared from one determines meet the criteria in § 170.39 or more of the optional substances of this chapter from regulation as food named in paragraph (c) of this section, additives and, therefore, a food addi- subject to any prescribed limitations. tive petition will not be required for (2) The adhesive is either separated the exempted use. from the food by a functional barrier or [60 FR 36596, July 17, 1995] used subject to the following additional limitations: (i) In dry foods. The quantity of adhe- PART 175—INDIRECT FOOD ADDI- sive that contacts packaged dry food TIVES: ADHESIVES AND COMPO- shall not exceed the limits of good NENTS OF COATINGS manufacturing practice. (ii) In fatty and aqueous foods. (a) The Subpart A [Reserved] quantity of adhesive that contacts packaged fatty and aqueous foods shall Subpart B—Substances for Use Only as not exceed the trace amount at seams Components of Adhesives and at the edge exposure between pack- Sec. aging laminates that may occur within 175.105 Adhesives. the limits of good manufacturing prac- 175.125 Pressure-sensitive adhesives. tice.
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(b) Under normal conditions of use and employed under the specific condi- the packaging seams or laminates will tions of use prescribed by such sanc- remain firmly bonded without visible tion or approval. separation. (3) Flavoring substances permitted (b) To assure safe usage of adhesives, for use in food by regulations in this the label of the finished adhesive con- part, provided that such flavoring sub- tainer shall bear the statement ‘‘food- stances are volatilized from the adhe- packaging adhesive’’. sives during the packaging fabrication (c) Subject to any limitation pre- process. scribed in this section and in any other regulation promulgated under section (4) Color additives approved for use in 409 of the Act which prescribes safe food. conditions of use for substances that (5) Substances permitted for use in may be employed as constituents of ad- adhesives by other regulations in this hesives, the optional substances used subchapter and substances named in in the formulation of adhesives may in- this subparagraph: Provided, however, clude the following: That any substance named in this (1) Substances generally recognized paragraph and covered by a specific as safe for use in food or food pack- regulation in this subchapter, must aging. meet any specifications in such regula- (2) Substances permitted for use in tion. adhesives by prior sanction or approval
Substances Limitations
Abietic acid. Acetone. Acetone-formaldehyde condensate (CAS Reg. No. 25619Ð09Ð4). 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. 35641Ð59Ð9). 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. 70983Ð55Ð0). 4-[2-[2-2-(Alkoxy (C12ÐC15) ethoxy) ethoxy]ethyl] disodium sulfosuccinate. 1-Alkyl (C6ÐC18) amino-3-amino-propane monoacetate. Alkylated (C4 and/or C8) phenols. Alkyl (C7ÐC12) benzene. Alkyl (C10ÐC20) 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 (C7ÐC12) naphthalene. alpha Olefin sulfonate [alkyl group is in the range of C10ÐC18 with not less than 50 percent C14ÐC16], ammonium, calcium, magnesium, po- tassium, and sodium salts. 2-[(2-aminoethyl)amino]ethanol (CAS Reg. No. 111Ð41Ð1). 3-Aminopropanediol ...... For use only in the preparation of polyurethane res- ins. Aluminum. Aluminum acetate. Aluminum di(2-ethylhexoate). Aluminum potassium silicate. N-β-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, sta- bilizer 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.
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Substances Limitations
Ammonium silico-fluoride ...... For use only as bonding agent for aluminum foil, sta- bilizer, 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. 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. 57569Ð40Ð1). 1,2ÐBenzisothiazolinÐ3Ðone (CAS Registry No. 2634Ð33Ð5) ...... 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. 105442Ð85Ð1) For use only as a reactant in the preparation of poly- ester 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. 32687Ð78Ð8). of the adhesive. 1,3-Bis(2-benzothiazolylmercaptomethyl) urea. 4,4′-Bis(α,α-dimethylbenzyl)diphenylamine. 2,6-Bis(1,1-dimethylethyl)-4-(1-methylpropyl)phenol (CAS Reg. No. For use as an antioxidant and/or stabilizer only. 17540Ð75Ð9). 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. 991Ð84Ð4). Bis(tri-n-butyltin) oxide ...... For use as preservative only. Bis(trichloromethyl)sulfone C.A. Registry No. 3064Ð70Ð8 ...... Do. Borax. Boric acid. 2-Bromo-2-nitro-1, 3-propanediol (CAS Reg. No. 52Ð51Ð7) ...... 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. 144093Ð88Ð9]).. 1,3-Butanediol. 1,4-Butanediol. 1,4-Butanediol modified with adipic acid. Butoxy polyethylene polyproplyene glycol (molecular weight 900Ð4,200). 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.
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Substances Limitations
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. Carbon black, channel process. Carbon disulfide-1,1′-methylenedipiperidine reaction product. Carbon tetrachloride. Carboxymethylcellulose. Castor oil, polyoxyethylated (4Ð84 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 C10ÐC17, containing 40Ð70 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 approxi- mately 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. 26172Ð55Ð4) and For use only as an antimicrobial agent in polymer 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682Ð20Ð4) mixture at a latex emulsions. ratio of 3 parts to 1 part, manufactured from methyl-3- mercaptopropionate (CAS Reg. No. 2935Ð90Ð2). The mixture may contain magnesium nitrate (CAS Reg. No. 10377Ð60Ð3) at a con- centration 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. 35541Ð81Ð2). Cyclohexanol. Cyclohexanone resin. Cyclohexanone-formaldehyde condensate. N-Cyclohexyl p-toluene sulfonamide. (η5-Cyclopentadienyl)-(η6-isopropylbenzene)iron(II) hexafluorophosphate For use only as a photoinitiator. (CAS Reg. No. 32760Ð80Ð8). 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 (C12ÐC24). 2,5-Di-tert-amylhydroquinone. Diamines derived from dimerized vegetable oil acids.
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Substances Limitations
Diaryl-p-phenylenediamine, where the aryl group may be phenyl, tolyl, or xylyl. 1,2ÐDibromoÐ2,4Ðdicyanobutane (CAS Registry No. 3569Ð65Ð7) ...... For use as a preservative only. 2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No. 10222Ð01Ð2)...... 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. 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.: 20018Ð09Ð01 ...... 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-β-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 ...... DipenteneÐstyrene resin (CAS Registry No. 64536Ð06Ð7). Diphenyl-2-ethylhexyl phosphate. Diphenyl, hydrogen ated.
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Substances Limitations
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. 37294Ð49Ð8). 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. 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. 97953Ð22Ð5). Ethoxypropanol butyl ether. Ethyl alcohol (ethanol). 5-Ethyl-1,3-diglycidyl-5-methylhydantoin (CAS Reg. No. 15336Ð82Ð0). Ethylene-acrylic acid-carbon monoxide copolymer (CAS Reg. No. 97756Ð27Ð9). 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. 25750Ð82Ð7). 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. 25052Ð62Ð4) con- taining not more than 30 weight percent of the units derived from car- bon 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 per- cent ethylene (CAS Reg. No. 26221Ð73Ð8). Ethylene-propylene-dicyclopentadiene copolymer rubber. Ethylene, propylene, 1,4-hexadiene and 2,5-norbornadiene tetrapolymer. Ethylene-vinyl acetate carbon monoxide terpolymer (CAS Registry No. 26337Ð35Ð9) containing not more than 15 weight percent of units de- rived from carbon monoxide. 2,2′-Ethylidenebis (4,6-di-tert-butylphenol) (CAS Reg. No. 35958Ð30Ð6). 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. 118337Ð09Ð0). Ethyl phthalyl ethyl glycolate. Ethyl-p-toluene sulfonamide ...... Fats and oils derived from animal or vegetable sources, and the hydro- genated, sulfated, or sulfonated forms of such fats and oils.
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Substances Limitations
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, sta- bilizer, or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesive. Formaldehyde. Formaldehyde o- and p-toluene sulfonamide. Formamide. Fumaratochromium (III) nitrate. Furfural. Furfuryl alcohol. Fumaric acid. gamma-Aminopropyltrimethoxysilane (CAS Reg. No. 13822Ð56Ð5). 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. 25791Ð96Ð2). 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 ter- pene stocks) (CAS Reg. No. 68239Ð99Ð6). Hydrocarbon resins (produced by the polymerization of styrene and alpha-methyl styrene), hydrogenated (CAS Reg. No. 68441Ð37Ð2). Hydrofluoric acid ...... For use only as bonding agent for aluminum foil, sta- bilizer, 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. 106168Ð39Ð2). Hydrogenated dipentene-styrene copolymer resin (CAS Reg. No. 106168Ð36Ð9). Hydrogenated-beta-pinene-alpha-pinene-dipentene copolymer resin (CAS Reg. No. 106168Ð37Ð0). a-Hydro-omega-hydroxypoly-(oxytetramethylene) ...... For use only in the preparation of polyurethane res- ins. Hydroquinone. Hydroquinone monobenzyl ether. Hydroquinone monoethyl ether. 2(2′-Hydroxy-3′,5′ di-tert-amylphenyl) benzotriazole. Hydroxyacetic acid. 7-Hydroxycoumarin. Hydroxyethylcellulose. 2ÐHydroxy-1-[4-(2-hydroxyethoxy)phenyl]-2-methyl-1-propanone(CAS For use only as a photoinitiator at a level not to ex- Reg. No. 106797Ð53Ð9). ceed 5 percent by weight of the adhesive. 1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2 alkyl (C6ÐC17) imidazolinium chlo- ride. Hydroxyethyldiethylenetriamine. β-Hydroxyethyl pyridinium 2-mercaptobenzothiazol. Hydroxyethyl starch. Hydroxyethylurea ......
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Substances Limitations
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. 3ÐIodoÐ2Ðpropynyl-N-butyl carbamate (CAS Reg. No. 55406Ð53Ð6) ...... 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. 131298Ð44Ð77). Isophorone. Isopropanolamine (mono-, di-, tri-). 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, sta- bilizer, 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).
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Substances Limitations
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. α-Naphthylamine. α,α′,α′′,α′′′-Neopentane tetrayltetrakis [omega-hydroxypoly (oxypropylene) (1Ð2 moles)], average molecular weight 400. Nitric acid. µ-Nitrobiphenyl. Nitrocellulose. 2-Nitropropane. α-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydro- gen phosphate and monohydrogen phosphate esters; the nonyl group is a propylene trimer isomer and the poly (oxyethylene) content aver- ages 6Ð9 moles or 50 moles. α(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 1Ð40 moles of ethylene oxide. α-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) sulfate, ammonium salt: the nonyl group is a propylene trimer isomer and the poly (oxy- ethylene) 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. 70331Ð94Ð1). Oxazoline. α-(oxiranylmethyl)-ω-(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. 26142Ð30Ð3). 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. 41638Ð13Ð based resins. 5). n-Oxydiethylene-benzothiazole. Palmitamide (palmitic acid amide). Paraffin (C12ÐC20) sulfonate. Paraformaldehyde. Pentachlorophenol. Pentaerythritol ester of maleic anhydride. Pentaerythritol monostearate ...... For use as preservative only. Pentaerythritol tetrabenzoate [CAS Registry No. 4196Ð86Ð5]. Pentaerythritol tetrastearate. 2,4-Pentanedione. Pentasodium diethylenetriaminepentaacetate (CAS Reg. No. 140Ð01Ð2). 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 copolymeriza- tion 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.
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Substances Limitations
Phenolic resins as described in ¤ 175.300(b)(3)(vi). Phenothiazine ...... For use only as polymerization-control agent. Phenyl-β-naphthylamine (free of β-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. 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. 9046Ð10Ð0). Poly(oxypropylene)diamine (weight average molecular weight 440) (CAS Reg. No. 9046Ð10Ð0). 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 gly- col 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. 94Ð60Ð0). Dimethyl-5-sulfoisophthalic acid (CAS Reg. No. 50975Ð82Ð1) and/or its sodium salt (CAS Reg. No. 3965Ð55Ð7). 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. 6362Ð79Ð4). Tetrahydrophthalic acid. Alcohols: 1,4-Cyclohexanedimethanol. 2,2-Dimethyl-1,3-propanediol. 1,6-Hexanediol (CAS Reg. No. 629Ð11Ð8). 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 200Ð6,000). Polyethylene glycol mono-isotridecyl ether sulfate, sodium salt (CAS Reg. No. 150413Ð26Ð6). Polyethyleneglycol alkyl(C10ÐC12) ether sulfosuccinate, disodium salt (CAS Reg. No. 68954Ð91Ð6). 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 pre- pared from glycerin and phthalic anhydride and modified with benzoic acid, castor oil, coconut oil, linseed oil, rosin, soybean oil, styrene, and vinyl toluene.
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Substances Limitations
Polymers: Homopolymers and copolymers of the following monomers:. Acrylamide. Acrylic acid. Acrylonitrile. Allylmethacrylate (CAS Reg. No. 00096Ð05Ð09). Butadiene. Butene. N-tert-Butylacrylamide. Butyl acrylate. 1,3-Butylene glycol dimethacrylate. Butyl methacrylate. Crotonic acid. Decyl acrylate. Diallyl fumarate. Diallyl maleate. Diallyl phthalate. Dibutyl fumarate. Dibutyl itaconate. Dibutyl maleate. Di(2-ethylhexyl) maleate. Dimethyl-α-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. 184785Ð 38Ð4). Fumaric acid and/or its methyl, ethyl, propyl, butyl, amyl hexyl, heptyl and octyl esters. Glycidyl methacrylate. 1ÐHexene (CAS Reg. No. 592Ð41Ð6). 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. 111Ð66Ð0). 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 formalde- hyde plus butyl- and/or amylphenols, oxyalkylated with ethylene oxide and/or propylene oxide).
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Substances Limitations
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 200Ð600) esters of fatty acids derived from animal or vegetable fats and oils (including tall oil). Polyoxyethylene (15 moles) ester of rosin. Polyoxyethylene (4Ð5 moles) ether of phenol. Polyoxyethylene (25 moles)—glycerol adduct. Polyoxyethylene (40 moles) stearate. Polyoxyethylene (5Ð15 moles) tridecyl alcohol. Polyoxypropylene (3 moles) tridecyl alcohol sulfate. Polyoxypropylene (20 moles) butyl ether. Polyoxypropylene (40 moles) butyl ether. Polyoxypropylene (20 moles) oleate butyl ether. Polyoxypropylene-polyoxyethylene condensate (minimum molecular weight 1,900). Polypropylene glycol (minimum molecular weight 150). Polypropylene glycol (3Ð4 moles) triether with 2-ethyl-2-(hydroxymethyl)- 1,3-propane-diol, average molecular weight 730. Polypropylene glycol dibenzoate (CAS Reg. No. 72245Ð46Ð6) ...... 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-α-(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) re- acting 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. 5124Ð30Ð1) with: (i) one or more of the polyols or polyesters named in this paragraph and with either N-methyldiethanolamine (CAS Reg. No. 105Ð59Ð9) and dimethyl sulfate (CAS Reg. No. 77Ð78Ð1) or dimethylolpropionic acid (CAS Reg. No. 4767Ð03Ð7) and triethylamine (CAS Reg. No. 121Ð44Ð8), or (ii) a fumaric acid-modified poly- propylene glycol or fumaric acid-modified tripropylene glycol), triethylamine (CAS Reg. No. 107Ð15Ð3), and ethylenediamine (CAS Reg. No. 121Ð44Ð8), or (4) reacting meta-tetramethylxylene diisocyanate (CAS Reg. No. 2778Ð42Ð9) with one or more of the polyols and polyesters listed in this paragraph and with dimethylolpropionic acid (CAS Reg. No. 4767Ð03Ð7) and triethylamine (CAS Reg. No. 121Ð44Ð8), N-methyldiethanolamine (CAS Reg. No. 105Ð59Ð9), 2Ðdimethylaminoethanol (CAS Reg. No. 108Ð01Ð0), 2Ð dimethylaminoÐ2ÐmethylÐ1Ðpropanol (CAS Reg. No. 7005Ð47Ð2), and/or 2ÐaminoÐ2ÐmethylÐ1Ðpropanol (CAS Reg. No. 124Ð68Ð5). Polyvinyl alcohol modified so as to contain not more than 3 weight per- cent of comonomer units derived from 1-alkenes having 12 to 20 car- bon 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.
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Substances Limitations
α, α′, α′′-1,2,3-Propanetriyltris [omega-(2,3-epoxypropoxy) poly (oxypropylene) (24 moles)]. β-Propiolactone. Propyl alcohol (propanol). Propylene carbonate. Propylene glycol and p-p′-isopropylidenediphenol diether. Propylene glycol dibenzoate (CAS Reg. No. 19224Ð26Ð1) ...... 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. α, α′, α′′-[Propylidynetris (methylene)] tris [omega-hydroxypoly (oxypropylene) (1.5 moles minimum)], minimum molecular weight 400. 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 (C1ÐC9) 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 there- of, 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 (C2ÐC13.5 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.
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Substances Limitations
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, sta- bilizer, or preservative. Total fluoride for all sources not to exceed 1 percent by weight of the finished adhesive. Sodium formaldehyde sulfoxylate. Sodium formate. Sodium heptadecylsulfate. Sodium hypochlorite. Sodium isododecylphenoxypolyethoxy (40 moles) sulfate. Sodium N-lauroyl sarcosinate. Sodium metaborate. Sodium α-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 percentÐ80 per- cent stearyl and 20 percentÐ35 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. 2Ðsulfoethyl methacrylate (CAS Registry No. 10595Ð80Ð9) ...... For use at levels not to exceed 2 percent by weight of the dry adhesive. α-Sulfo-omega-(dodecyloxy)poly (oxyethylene), ammonium salt. Sulfonated octadecylene (sodium form). Sulfosuccinic acid 4-ester with polyethylene glycol dodecyl ether diso- dium salt (alcohol moiety produced by condensation of 1 mole of n- dodecyl alcohol and an average of 5Ð6 moles of ethylene oxide, Chemical Abstracts Service Registry No. 039354Ð45Ð5). Sulfosuccinic acid 4-ester with polyethylene glycol nonylphenyl ether, di- sodium salt (alcohol moiety produced by condensation of 1 mole of nonylphenol and an average of 9Ð10 moles of ethylene oxide) (CAS Reg. No. 9040Ð38Ð4).
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Substances Limitations
Sulfur. Synthetic primary linear aliphatic alcohols whose weight average molec- ular weight is greater than 400 (CAS Reg. No. 71750Ð71Ð5). 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. Terpene resins (α-and β-pinene) homopolymers, copolymers, and con- densates 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)] meth- ane. 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 1Ð40 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 6Ð9 or 40 moles. Tetramethyl decanediol. Tetramethyl decynediol. Tetramethyl decynediol plus 1Ð30 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-β-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.
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Substances Limitations
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 mo- lecular 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. Tris (p-tertiary butyl phenyl) phosphate. Tris(2-methyl-4-hydroxy-5-tert-butyl-phenyl)butane. Trisodium N-hydroxyethylethylenediaminetriacetate (CAS Reg. No. 139Ð 89Ð9). 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. (2) Substances used in accordance with a prior sanction or approval. Pressure-sensitive adhesives may be safely used as the food-contact surface (3) Color additives listed for use in or of labels and/or tapes applied to food, on food in parts 73 and 74 of this chap- in accordance with the following pre- ter. scribed conditions: (4) Substances identified in § 172.615 of (a) Pressure-sensitive adhesives pre- this chapter other than substances pared from one or a mixture of two or used in accordance with paragraph more of the substances listed in this (a)(2) of this section. paragraph may be used as the food-con- (5) Polyethylene, oxidized; complying tact surface of labels and/or tapes ap- with the identity prescribed in plied to poultry, dry food, and proc- § 177.1620(a) of this chapter. essed, frozen, dried, or partially dehy- (6) 4-[[4, 6-Bis(octylthio)-s-triazin-2- drated fruits or vegetables. yl]amino]-2,6-di-tert-butylphenol (CAS (1) Substances generally recognized Reg. No. 991–84–4) as an antioxidant/ as safe in food. stabilizer at a level not to exceed 1.5
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percent by weight of the finished pres- cis-1,4-Polyisoprene. sure-sensitive adhesive. Polystyrene. (7) 2,2′-(2,5-Thiophenediyl)-bis(5-tert- Propyl gallate. Rapeseed oil, vulcanized. butylbenzoxazole) (CAS Reg. No. 7128– Rosins and rosin derivatives as provided in 64–5) as an optical brightener at a level § 178.3870 of this chapter. not to exceed 0.05 percent by weight of Rubber hydrochloride. the finished pressure-sensitive adhe- Rubber (natural latex solids or crepe, sive. smoked or unsmoked). (8) 2-Hydroxy-1-[4-(2-hydroxyethoxy) Terpene resins (α- and β-pinene), phenyl]-2-methyl-1-propanone (CAS homopolymers, copolymers, and conden- sates with phenol, formaldehyde, cou- Reg. No. 106797–53–9) as a photoinitiator marone, and/or indene. at a level not to exceed 5 percent by Tetrasodium ethylenediaminetetraacetate. weight of the pressure-sensitive adhe- Tri(mixed mono- and dinonylphenyl) sive. phosphite (which may contain not more (9) Butanedioic acid, sulfo-1,4-di-(C9- than 1 percent by weight of triisopropanolamine). C11 alkyl) ester, ammonium salt (also known as butanedioic acid sulfo-1, 4- (c) Acrylonitrile copolymers identi- diisodecyl ester, ammonium salt [CAS fied in this section shall comply with Reg. No. 144093–88–9]) as a surface ac- the provisions of § 180.22 of this chap- tive agent at a level not to exceed 3.0 ter. percent by weight of the finished pres- [42 FR 14534, Mar. 15, 1977, as amended at 42 sure-sensitive adhesive. FR 15674, Mar. 22, 1977; 48 FR 15617, Apr. 12, (b) Pressure-sensitive adhesives pre- 1983; 63 FR 3464, Jan. 23, 1998; 63 FR 51528, pared from one or a mixture of two or Sept. 28, 1998; 64 FR 48291, Sept. 3, 1999] more of the substances listed in this paragraph may be used as the food-con- Subpart C—Substances for Use as tact surface of labels and/or tapes ap- Components of Coatings plied to raw fruit and raw vegetables. (1) Substances listed in paragraphs § 175.210 Acrylate ester copolymer (a)(1), (a)(2), (a)(3), (a)(5), (a)(6), (a)(7), coating. (a)(8), and (a)(9) of this section, and Acrylate ester copolymer coating those substances prescribed by para- may safely be used as a food-contact graph (a)(4) of this section that are not surface of articles intended for pack- identified in paragraph (b)(2) of this aging and holding food, including heat- section. ing of prepared food, subject to the pro- (2) Substances identified in this sub- visions of this section: paragraph and subject to the limita- (a) The acrylate ester copolymer is a tions provided: fully polymerized copolymer of ethyl BHA. acrylate, methyl methacrylate, and BHT. methacrylic acid applied in emulsion Butadiene-acrylonitrile copolymer. form to molded virgin fiber and heat- Butadiene-acrylonitrile-styrene copolymer. cured to an insoluble resin. Butadiene-styrene copolymer. (b) Optional substances used in the Butyl rubber. preparation of the polymer and in the Butylated reaction product of p-cresol and preparation and application of the dicyclopentadiene produced by reacting p- cresol and dicyclopentadiene in an approxi- emulsion may include substances mate mole ratio of 1.5 to 1.0, respectively, named in this paragraph, in an amount followed by alkylation with isobutylene so not to exceed that required to accom- that the butyl content of the final product plish the desired technical effect and is not less than 18 percent, for use at levels subject to any limitation prescribed: not to exceed 1.0 percent by weight of the Provided, however, That any substance adhesive formulation. named in this paragraph and covered Chlorinated natural rubber. by a specific regulation in subchapter Isobutylene-styrene copolymer. Petrolatum. B of this chapter must meet any speci- Polybutene-1. fications in such regulation. Polybutene, hydrogenated; complying with List of substances Limitations the identity prescribed under § 178.3740(b) of this chapter. Aluminum stearate. Polyisobutylene. Ammonium lauryl sulfate.
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List of substances Limitations packing, processing, preparing, treat- ing, packaging, transporting, or hold- Borax ...... Not to exceed the amount required as a ing food in accordance with the fol- preservative in emul- lowing prescribed conditions: sion defoamer. (a) The additive is synthesized by the Disodium hydrogen phosphate ..... Do. Fischer-Tropsch process from carbon Formaldehyde. Glyceryl monostearate. monoxide and hydrogen, which are cat- Methyl cellulose. alytically converted to a mixture of Mineral oil. paraffin hydrocarbons. Lower molec- Paraffin wax. Potassium hydroxide. ular-weight fractions are removed by Potassium persulfate. distillation. The residue is hydro- Tallow. genated and may be further treated by Tetrasodium pyrophosphate. Titanium dioxide. percolation through activated char- coal. This mixture can be fractionated (c) The coating in the form in which into its components by a solvent sepa- it contacts food meets the following ration method, using synthetic tests: isoparaffinic petroleum hydrocarbons (1) An appropriate sample when ex- complying with § 178.3530 of this chap- posed to distilled water at 212 °F for 30 ter. 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, VIIA, and IX identified in table 1 of § 175.230 Hot-melt strippable food § 176.170(c) of this chapter and under coatings. conditions of use E, F, and G described Hot-melt strippable food coatings in table 2 of § 176.170(c) of this chapter may be safely applied to food, subject shall be limited to a concentration not to the provisions of this section. exceeding 15 percent by weight of the (a) The coatings are applied to and finished coating. The congealing point used as removable coatings for food. shall be determined by ASTM method (b) The coatings may be prepared, as D938–71 (Reapproved 1981), ‘‘Standard mixtures, from the following sub- Test Method for Congealing Point of stances: Petroleum Waxes, Including Petro- (1) Substances generally recognized latum,’’ which is incorporated by ref- as safe in food. erence. Copies may be obtained from (2) Substances identified in this sub- the American Society for Testing Ma- paragraph. terials, 1916 Race St., Philadelphia, PA List of substances Limitations 19103, or may be examined at the Office of the Federal Register, 800 North Cap- Acetylated monoglycerides ...... Complying with 172.828 itol Street, NW., suite 700, Washington, of this chapter. Cellulose acetate butyrate. DC 20408. Cellulose acetate propionate. (2) Oil content. The substance has an Mineral oil, white ...... For use only as a com- oil content not exceeding 2.5 percent as ponent of hot-melt strippable food coat- determined by ASTM method D721–56T, ings applied to frozen ‘‘Tentative Method of Test for Oil Con- meats and complying tent of Petroleum Waxes’’ (Revised with ¤ 172.878 of this 1956), which is incorporated by ref- chapter. erence. See paragraph (b)(1) of this sec- tion for availability of the incorpora- § 175.250 Paraffin (synthetic). tion by reference. Synthetic paraffin may be safely (3) Absorptivity. The substance has an used as an impregnant in, coating on, absorptivity at 290 millimicrons in or component of coatings on articles decahydronaphthalene at 88 °C not ex- used in producing, manufacturing, ceeding 0.01 as determined by ASTM
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method E131–81a, ‘‘Standard Defini- § 175.270 Poly(vinyl fluoride) resins. tions of Terms and Symbols Relating Poly(vinyl fluoride) resins identified to Molecular-Spectroscopy,’’ which is in this section may be safely used as incorporated by reference. See para- components of food-contact coatings graph (b)(1) of this section for avail- for containers having a capacity of not ability of the incorporation by ref- less than 5 gallons, subject to the pro- erence. visions of this section. (c) The provisions of this section are (a) For the purpose of this section, not applicable to synthetic paraffin poly(vinyl fluoride) resins consist of used in food-packaging adhesives com- basic resins produced by the polym- plying with § 175.105. erization of vinyl fluoride. [42 FR 14534, Mar. 15, 1977, as amended at 47 (b) The poly(vinyl fluoride) basic res- FR 11839, Mar. 19, 1982; 49 FR 10106, Mar. 19, ins have an intrinsic viscosity of not 1984; 51 FR 47010, Dec. 30, 1986; 60 FR 39645, less than 0.75 deciliter per gram as de- Aug. 3, 1995] termined by ASTM method D1243–79, ‘‘Standard Test Method for Dilute So- § 175.260 Partial phosphoric acid lution Viscosity of Vinyl Chloride esters of polyester resins. Polymers,’’ which is incorporated by Partial phosphoric acid esters of pol- reference. Copies may be obtained from yester resins identified in this section the American Society for Testing Ma- and applied on aluminum may be safely terials, 1916 Race St., Philadelphia, PA used as food-contact coatings, in ac- 19103, or may be examined at the Office cordance with the following prescribed of the Federal Register, 800 North Cap- conditions: itol Street, NW., suite 700, Washington, (a) For the purpose of this section, DC 20408. partial phosphoric acid esters of poly- (1) Solvent. N,N-Dimethylacetamide, ester resins are prepared by the reac- technical grade. tion of trimellitic anhydride with 2,2- (2) Solution. Powdered resin and sol- ° dimethyl-1,3-propanediol followed by vent are heated at 120 C until the resin is dissolved. reaction of the resin thus produced with phosphoric acid anhydride to (3) Temperature. Flow times of the solvent and solution are determined at produce a resin having an acid number 110 °C. of 81 to 98 and a phosphorus content of (4) Cannon-Ubbelohde size 4.05 to 4.65 percent by weight. Viscometer. 50 semimicro dilution viscometer (or (b) The coating is chemically bonded equivalent). to the metal and cured at temperatures (5) Calculation. The calculation meth- exceeding 450 °F. od used is that described in appendix X (c) The finished food-contact coating, 1.3 (ASTM method D1243–79, ‘‘Standard when extracted with the solvent or sol- Test Method for Dilute Solution Vis- vents characterizing the type of food cosity of Vinyl Chloride Polymers,’’ and under the conditions of time and which is incorporated by reference; see temperature characterizing the condi- paragraph (b) of this section for avail- tions of its intended use, as determined ability of the incorporation by ref- from tables 1 and 2 of § 175.300(d), yields erence) with the reduced viscosity de- total extractives in each extracting termined for three concentration levels solvent not to exceed 0.3 milligrams not greater than 0.5 gram per deciliter per square inch of food-contact surface, and extrapolated to zero concentration as determined by the methods de- for intrinsic viscosity. The following scribed in § 175.300(e), and the coating formula is used for determining re- yields 2,2-dimethyl-1,3-propanediol in duced viscosity: each extracting solvent not to exceed − 0.3 micrograms per square inch of food- Reduced viscosity in terms = tto 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.
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c=Concentration of solution in terms of Fish (refined). grams per deciliter. Hempseed. Linseed. [42 FR 14534, Mar. 15, 1977, as amended at 47 Oiticica. FR 11839, Mar. 19, 1982; 49 FR 10107, Mar. 19, Perilla. 1984] Poppyseed. Pumpkinseed. § 175.300 Resinous and polymeric coat- Safflower. ings. Sesame. Resinous and polymeric coatings Soybean. may be safely used as the food-contact Sunflower. surface of articles intended for use in Tall oil. producing, manufacturing, packing, Walnut. processing, preparing, treating, pack- The oils may be raw, heat-bodied, or aging, transporting, or holding food, in blown. They may be refined by filtra- accordance with the following pre- tion, degumming, acid or alkali wash- scribed conditions: ing, bleaching, distillation, partial de- (a) The coating is applied as a contin- hydration, partial polymerization, or uous film or enamel over a metal sub- solvent extraction, or modified by com- strate, or the coating is intended for bination with maleic anhydride. repeated food-contact use and is ap- (ii) Reconstituted oils from plied to any suitable substrate as a triglycerides or fatty acids derived continuous film or enamel that serves from the oils listed in paragraph as a functional barrier between the (b)(3)(i) of this section to form esters food and the substrate. The coating is with: characterized by one or more of the fol- lowing descriptions: Butylene glycol. (1) Coatings cured by oxidation. Ethylene glycol. (2) Coatings cured by polymerization, Pentaerythritol. Polyethylene glycol. condensation, and/or cross-linking Polypropylene glycol. without oxidation. Propylene glycol. (3) Coatings prepared from prepoly- Sorbitol. merized substances. Trimethylol ethane. (b) The coatings are formulated from Trimethylol propane. optional substances that may include: (iii) Synthetic drying oils, as the (1) Substances generally recognized basic polymer: as safe in food. (2) Substances the use of which is Butadiene and methylstyrene copolymer. permitted by regulations in this part Butadiene and styrene copolymer, blown or or which are permitted by prior sanc- unblown. Maleic anhydride adduct of butadiene sty- tion or approval and employed under rene. the specific conditions, if any, of the Polybutadiene. prior sanction or approval. (3) Any substance employed in the (iv) Natural fossil resins, as the basic production of resinous and polymeric resin: coatings that is the subject of a regula- Copal. tion in subchapter B of this chapter Damar. and conforms with any specification in Elemi. such regulation. Substances named in Gilsonite. this paragraph (b)(3) and further identi- Glycerol ester of damar, copal, elemi, and fied as required: sandarac. Sandarac. (i) Drying oils, including the Shellac. triglycerides or fatty acids derived Utah coal resin. therefrom: (v) Rosins and rosin derivatives, with Beechnut. or without modification by polymeriza- Candlenut. tion, isomerization, incidental Castor (including dehydrated). Chinawood (tung). decarboxylation, and/or hydrogenation, Coconut. as follows: Corn. (a) Rosins, refined to color grade of K Cottonseed. or paler:
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Gum rosin. 1,4-cyclohexanedicarboxylic (CAS Reg. No. Tall oil rosin. 1076–97–7). Wood rosin. Dimerized fatty acids derived from oils listed in paragraph (b)(3)(i) of this section. (b) Rosin esters formed by reacting Fumaric. rosin (paragraph (b)(3)(v)(a) of this sec- Isophthalic. tion) with: Maleic. 4,4′-sec-Butylidenediphenol-epichlorohydrin 2,6-Naphthalenedicarboxylic. (epoxy). 2,6-Naphthalenedicarboxylic, dimethyl ester. Diethylene glycol. Orthophthalic. Ethylene glycol. Sebacic. Glycerol. Terephthalic. 4,4′-Isopropylidenediphenol-epichlorohydrin Terpene-maleic acid adduct. (epoxy). Trimellitic. Methyl alcohol. Pentaerythritol. (b) Monobasic acids: (c) Rosin esters (paragraph (b)(3)(v)(b) Benzoic acid. ′ of this section) modified by reaction 4,4-Bis(4 -hydroxyphenyl)-pentanoic acid. tert-Butyl benzoic acid. with: Fatty acids derived from oils listed in para- Maleic anhydride. graph (b)(3)(i) of this section. o-, m-, and p-substituted phenol-formalde- Rosins listed in paragraph (b)(3)(v)(a) of this hydes listed in paragraph (b)(3)(vi) of this section, for use only as reactants in oil- section. based or fatty acid-based alkyd resins. Phenol-formaldehyde. (c) Polyhydric alcohols: (d) Rosin salts: Butylene glycol. Calcium resinate (limed rosin). Diethylene glycol. Zinc resinate. 2,2-Dimethyl-1,3-propanediol for use only in forming polyester resins for coatings in- (vi) Phenolic resins as the basic poly- tended for use in contact with non-alco- mer formed by reaction of phenols with holic foods. formaldehyde: Ethylene glycol. (a) Phenolic resins formed by reac- Glycerol. tion of formaldehyde with: Mannitol. α-Methyl glucoside. Alkylated (methyl, ethyl, propyl, isopropyl, Pentaerythritol. butyl) phenols. Propylene glycol. p-tert-Amylphenol. Sorbitol. 4,4′-sec-Butylidenediphenol. p-tert-Butylphenol. Triethylene glycol, for use as a component in o-, m-, and p-Cresol. polyester resins for coatings not exceeding p-Cyclohexylphenol. a coating weight of 4 milligrams per square 4,4′-Isopropylidenediphenol. inch and that are intended for contact p-Nonylphenol. under conditions of use D, E, F or G de- p-Octylphenol. scribed in table 2 of paragraph (d) of this 3-Pentadecyl phenol mixture obtained from section with alcoholic beverages con- cashew nut shell liquid. taining less than 8 percent alcohol. Phenol. Trimethylol ethane. Phenyl o-cresol. Trimethylol propane. p-Phenylphenol. (d) Monohydric alcohols: Xylenol. Cetyl alcohol. (b) Adjunct for phenolic resins: Alu- Decyl alcohol. minum butylate. Lauryl alcohol. (vii) Polyester resins (including Myristyl alcohol. alkyd-type), as the basic polymers, Octyl alcohol. formed as esters of acids listed in para- Stearyl alcohol. graph (b)(3)(vii) (a) and (b) of this sec- (e) Catalysts: tion by reaction with alcohols in para- graph (b)(3)(vii) (c) and (d) of this sec- Dibutyltin oxide (CAS Reg. No. 818–08–6), not tion. to exceed 0.2 percent of the polyester resin. (a) Polybasic acids: Hydroxybutyltin oxide (CAS Reg. No. 2273– 43–0), not to exceed 0.2 percent of the poly- Adipic. ester resin.
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Monobutyltin tris(2-ethylhexoate) (CAS Reg. under Category I and Category VIII, at No. 23850–94–4), not to exceed 0.2 percent of temperatures not exceeding 88 °C (190 °F). the polyester resin. N-Beta-(aminoethyl)-gamma-aminopropyltri- methoxysilane (CAS Reg. No. 1760–24–3), for (viii) Epoxy resins, catalysts, and ad- use only in coatings at a level not to ex- juncts: ceed 1.3 percent by weight of the resin (a) Epoxy resins, as the basic poly- when such coatings are intended for re- mer: peated use in contact with foods only of the types identified in paragraph (d) of this (Alkoxy C10–C16)-2,3-epoxypropane, in which section, table 1, under Types I, II, and III, the alkyl groups are even numbered and under conditions of use C, D, E, or F as de- consist of a maximum of 1 percent C10 car- scribed in table 2 of paragraph (d) of this bon atoms and a minimum of 48 percent C12 section; or when such coatings are in- carbon atoms and a minimum of 18 percent tended for repeated use in contact with C14 carbon atoms, for use only in coatings foods of the types identified in paragraph that are intended for contact with dry bulk (d) of this section, table 1, under Types V, foods at room temperature. VI, VII, and VIII, under conditions of use E 4,4′-sec-Butylidenediphenol-epichlorohydrin. or F as described in table 2 of paragraph (d) 4,4′-sec-Butylidenediphenol-epichlorohydrin of this section. Use shall be limited to reacted with one or more of the drying oils coatings for tanks of capacity greater than or fatty acids listed in paragraph (b)(3)(i) 530,000 gallons. of this section. Benzyl alcohol (CAS Reg. No. 100–51–6), for 4,4′-sec-Butylidenediphenol-epichlorohydrin use only in coatings at a level not to ex- chemically treated with one or more of ceed 4 percent by weight of the resin when the following substances: such coatings are intended for repeated use Allyl ether of mono-, di-, or trimethylol in contact with foods only of the types phenol. identified in paragraph (d) of this section, 4,4′-sec-Butylidenediphenol-formaldehyde. table 1, under Types I, II, and III, under 4,4′-Isopropylidenediphenol-formaldehyde. conditions of use C, D, E, or F as described Melamine-formaldehyde. in table 2 of paragraph (d) of this section; Phenol-formaldehyde. or when such coatings are intended for re- Urea-formaldehyde. peated use in contact with foods of the Epoxidized polybutadiene. types identified in paragraph (d) of this Glycidyl ethers formed by reacting section, table 1, under Types V, VI, VII, phenolnovolak resins with and VIII, under conditions of use E or F as epichlorohydrin. described in table 2 of paragraph (d) of this 4,4′-Isopropylidenediphenol-epichlorohydrin. section. Use shall be limited to coatings 4,4′-Isopropylidenediphenol-epichlorohydrin for tanks of capacity greater than 530,000 reacted with one or more of the drying oils gallons. or fatty acids listed in paragraph (b)(3)(i) Catalysts and cross-linking agents for epoxy of this section. resins: 4,4′-Isopropylidenediphenol-epichlorohydrin 3-Aminomethyl-3,5,5- chemically treated with one or more of trimethylcyclohexylamine (CAS Reg. No. the following substances: 2855–0913–092). 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 re- ° dry 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
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coatings for tanks of capacity greater than tended for repeated use in contact with al- 530,000 gallons. coholic beverages containing up to 8 per- Diethylenetriamine. cent of alcohol by volume. Diphenylamine. Tetraethylenepentamine. Ethylenediamine. Tetraethylenepentamine reacted with Isophthalyl dihydrazide for use only in coat- equimolar quantities of fatty acids. ings subject to the provisions of paragraph Tri(dimethylaminomethyl) phenol and its (c) (3) or (4) of this section. salts prepared from the fatty acid moieties 4,4′-Methylenedianiline, for use only in coat- of the salts listed in paragraph ings for containers having a capacity of (b)(3)(xxii)(b) of this section, for use only 1,000 gallons or more when such containers in coatings subject to the provisions of are intended for repeated use in contact paragraph (c) (3) or (4) of this section. with alcoholic beverages containing up to 8 Triethylenetetramine. percent of alcohol by volume. Trimellitic anhydride (CAS Reg. No. 552–30– N-Oleyl-1,3-propanediamine with not more 7) for use only as a cross-linking agent at than 10 percent by weight of a level not to exceed 15 percent by weight diethylaminoethanol. of the resin in contact with food under all 3-Pentadecenyl phenol mixture (obtained conditions of use, except that resins in- from cashew nutshell liquid) reacted with tended for use with foods containing more formaldehyde and ethylenediamine in a than 8 percent alcohol must contact such ratio of 1:2:2 (CAS Reg. No. 68413–28–5). food only under conditions of use D, E, F, 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
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table 2 of paragraph (d) of this section. Use Urea-formaldehyde chemically modified with shall be limited to coatings for tanks of ca- one or more of the amine catalysts listed pacity greater than 530,000 gallons. in paragraph (b)(3)(viii)(b) of this section. (c) Adjuncts for epoxy resins: (b) Curing (cross-linking) catalyst for urea-formaldehyde resins: Aluminum butylate. Benzoic acid, for use as a component in Dodecyl benzenesulfonic acid (C.A. Registry epoxy resins for coatings not exceeding a No. 27176–87–0). coating weight of 4 milligrams per square inch and that are intended for contact (xiii) Triazine-formaldehyde resins under conditions of use D, E, F or G de- and their curing catalyst: scribed in table 2 of paragraph (d) of this (a) Triazine-formaldehyde resins, as section with alcoholic beverages con- the basic polymer: taining less than 8 percent alcohol. Polyamides from dimerized vegetable oils Benzoguanamine-formaldehyde. and the amine catalysts listed in para- Melamine-formaldehyde. graph (b)(3)(viii)(b) of this section, as the Melamine-formaldehyde chemically modified basic polymer. with one or more of the following amine Silane coupled silica, prepared from the re- catalysts: action of microcrystalline quartz with N- Amine catalysts listed in paragraph beta-(N-vinylbenzylamino) ethyl-gamma- (b)(3)(viii)(b) of this section. aminopropyltrimethoxy silane, mono- Dimethylamine-2-methyl-1-propanol. hydrogen chloride, for use only in coatings Methylpropanolamine. intended for repeated use in contact with Triethanolamine. foods only of the types identified in para- Melamine-formaldehyde chemically modified graph (d) of this section, table 1, under with methyl, ethyl, propyl, isopropyl, Category I and Category VIII, at tempera- butyl, or isobutyl alcohol. ° ° tures not exceeding 88 C (190 F). (b) Curing (cross-linking) catalyst for Succinic anhydride, for use as a component triazine-formaldehyde resins: in epoxy resins for coatings not exceeding a coating weight of 4 milligrams per square Dodecyl benzenesulfonic acid (C.A. Registry inch, and that are intended for contact No. 27176–87–0). under conditions of use D, E, F or G de- scribed in table 2 of paragraph (d) of this (xiv) Modifiers (for oils and alkyds, section with alcoholic beverages con- including polyesters), as the basic poly- taining less than 8 percent alcohol. mer: (ix) Coumarone-indene resin, as the Butyl methacrylate. basic polymer. Cyclopentadiene. (x) Petroleum hydrocarbon resin Methyl, ethyl, butyl, or octyl esters of acryl- (cyclopentadiene type), as the basic ic acid. polymer. Methyl methacrylate. Styrene. (xi) Terpene resins, as the basic poly- Vinyl toluene. mer, from one or more of the following: (xv) Vinyl resinous substance, as the Dipentene. basic polymers: Hydrogenated dipentene resin (CAS Reg. No. 106168–39–2). For use only with coatings in Polyvinyl acetate. contact with acidic and aqueous foods. Polyvinyl alcohol. Hydrogenated-beta-pinene-alpha-pinene- Polyvinyl butyral. dipentene copolymer resin (CAS Reg. No. Polyvinyl chloride. 106168–37–0). For use only with coatings in Polyvinyl formal. contact with acidic and aqueous foods. Polyvinylidene chloride. α-Pinene. Polyvinyl pyrrolidone. β-Pinene. Polyvinyl stearate. Vinyl chloride-acetate-2,3-epoxypropyl meth- (xii) Urea-formaldehyde, resins and acrylate copolymers containing not more their curing catalyst: than 10 weight percent of total polymer (a) Urea-formaldehyde resins, as the units derived from 2,3-epoxypropyl meth- basic polymer: acrylate and not more than 0.1 weight per- cent of unreacted 2,3-epoxypropyl meth- Urea-formaldehyde. acrylate monomer for use in coatings for Urea-formaldehyde chemically modified with containers. methyl, ethyl, propyl, isopropyl, butyl, or Vinyl chloride-acetate, hydroxyl-modified isobutyl alcohol. copolymer.
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Vinyl chloride-acetate, hydroxyl-modified Ethylene-isobutyl acrylate copolymers con- copolymer, reacted with trimellitic anhy- taining no more than 35 weight percent of dride. total polymer units derived from isobutyl Vinyl chloride copolymerized with acryl- acrylate. amide and ethylene in such a manner that Ethylene-vinyl acetate copolymer. the finished copolymers have a minimum Polyethylene. weight average molecular weight of 30,000 (xix) Polypropylene as the basic poly- and contain not more than 3.5 weight per- cent of total polymer units derived from mer: acrylamide; the acrylamide portion may or Polypropylene. may not be subsequently partially Maleic anhydride adduct of polypropylene hydrolyzed. The polypropylene used in the manufac- Vinyl chloride copolymerized with one or ture of the adduct complies with more of the following substances: § 177.1520(c), item 1.1; and the adduct has a Acrylonitrile. maximum combined maleic anhydride con- Fumaric acid and/or its methyl, ethyl, tent of 0.8 percent and a minimum intrin- propyl, butyl, amyl, hexyl, heptyl, or octyl sic viscosity of 0.9, determined at 135 °C on esters. a 0.1 percent solution of the modified poly- Maleic acid and/or its methyl, ethyl, propyl, propylene in decahydronaphthalene as de- butyl, amyl, hexyl, heptyl, or octyl esters. termined by a method titled ‘‘Method for 5-Norbornene-2,3-dicarboxylic acid, mono-n- Determination of Intrinsic Viscosity of butyl ester; for use such that the finished Maleic Anhydride Adduct of Poly- vinyl chloride copolymers contain not propylene,’’ which is incorporated by ref- more than 4 weight percent of total poly- erence. Copies are available from the Cen- mer units derived from this comonomer. ter for Food Safety and Applied Nutrition Vinyl acetate. (HFS–200), Food and Drug Administration, Vinylidene chloride. 200 C St. SW., Washington, DC 20204, or Vinyl chloride-vinylidene chloride-2,3- available for inspection at the Office of the epoxypropyl methacrylate copolymers con- Federal Register, 800 North Capitol Street, taining not more than 10 weight percent of NW., suite 700, Washington, DC 20408. total polymer units derived from 2,3- epoxypropyl methacrylate and not more (xx) Acrylics and their copolymers, than 0.05 weight percent of unreacted 2,3- as the basic polymer: epoxypropyl methacrylate monomer based Acrylamide with ethylacrylate and/or sty- on polymer solids for use only in coatings rene and/or methacrylic acid, subsequently for containers intended for contact with reacted with formaldehyde and butanol. foods under conditions B, C, D, E, F, G, or Acrylic acid and the following esters thereof: H described in table 2 of paragraph (d) of Ethyl. this section. Methyl. (xvi) Cellulosics, as the basic poly- Butyl acrylate-styrene-methacrylic acid-hy- mer: droxyethyl methacrylate copolymers con- taining no more than 20 weight percent of Carboxymethylcellulose. total polymer units derived from meth- Cellulose acetate. acrylic acid and containing no more than 7 Cellulose acetate-butyrate. weight percent of total polymer units de- Cellulose acetate-propionate. rived from hydroxyethyl methacrylate; for Ethylcellulose. use only in coatings that are applied by Ethyl hydroxyethylcellulose. electrodeposition to metal substrates. Hydroxyethylcellulose. Butyl acrylate-styrene-methacrylic acid- Hydroxypropyl methylcellulose. hydroxypropyl methacrylate copolymers Methylcellulose. containing no more than 20 weight percent Nitrocellulose. of total polymer units derived from meth- acrylic acid and containing no more than 7 (xvii) Styrene polymers, as the basic weight percent of total polymer units de- polymer: rived from hydroxypropyl methacrylate; for use only in coatings that are applied by Polystyrene. electrodeposition to metal substrates and α -Methyl styrene polymer. that are intended for contact, under condi- Styrene copolymerized with one or more of tion of use D, E, F, or G described in table the following: 2 of paragraph (d) of this section, with food Acrylonitrile. containing no more than 8 percent of alco- α -Methylstyrene. hol. (xviii) Polyethylene and its copoly- Ethyl acrylate-styrene-methacrylic acid co- mers as the basic polymer: polymers for use only as modifiers for epoxy resins listed in paragraph Ethylene-ethyl acrylate copolymer. (b)(3)(viii)(a) of this section.
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Ethyl acrylate-methyl methacrylate-sty- Type VIII without use temperature restric- rene-methacrylic acid copolymers for use tion. only as modifiers for epoxy resins listed in paragraph (b)(3)(viii)(a) of this section. (xxi) Elastomers, as the basic poly- 2-Ethylhexyl acrylate-ethyl acrylate copoly- mer: mers prepared by copolymerization of 2- Butadiene-acrylonitrile copolymer. ethylhexyl acrylate and ethyl acrylate in a Butadiene-acrylonitrile-styrene copolymer. 7/3 weight ratio and having a number aver- Butadiene-styrene copolymer. age molecular weight range of 5,800 to 6,500 ° Butyl rubber. and a refractive index, nD25 (40 percent in Chlorinated rubber. 2,2,4-trimethyl pentane) of 1.4130–1.4190; for 2-Chloro-1,3-butadiene (neoprene). use as a modifier for nylon resins com- Natural rubber (natural latex or natural plying with § 177.1500 of this chapter and for latex solids, smoked or unsmoked). phenolic and epoxy resins listed in para- Polyisobutylene. graph (b)(3) (vi) and (viii) of this section, Rubber hydrochloride. respectively, at a level not to exceed 1.5 Styrene-isobutylene copolymer. percent of the coating. 2-Ethylhexyl acrylate-methyl methacrylate- (xxii) Driers made by reaction of a acrylic acid copolymers for use only as metal from paragraph (b)(3)(xxii)(a) of modifiers for epoxy resins listed in para- this section with acid, to form the salt graph (b)(3)(viii) of this section. listed in paragraph (b)(3)(xxii)(b) of this Methacrylic acid and the following esters thereof: section: Butyl. (a) Metals: 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 of total polymer units derived from meth- (b) Salts: acrylic acid and containing no more than 9.5 weight percent of total polymer units Caprate. derived from hydroxyethyl methacrylate; Caprylate. for use only in coatings in contact with dry Isodecanoate. food (food type VIII in table 1 of paragraph Linoleate. (d) of this section). 2-(Dimethylamino) eth- Naphthenate. anol (C.A.S. Registry No. 108–01–0) may be Neodecanoate. employed as an optional adjuvant sub- Octoate (2-ethylhexoate). stance limited to no more than 2 weight Oleate. percent based on polymer solids in the Palmitate. coating emulsion. Resinate. Styrene polymers made by the polymeriza- Ricinoleate. tion of any combination of styrene or Soyate. alpha methyl styrene with acrylic acid, Stearate. methacrylic acid, 2-ethyl hexyl acrylate, Tallate. methyl methacrylate, and butyl acrylate. (xxiii) Waxes: The styrene and alpha methyl styrene, in- dividually, may constitute from 0 to 80 Paraffin, Type I. weight percent of the polymer. The other Paraffin, Type II. monomers, individually, may be from 0 to Polyethylene. 40 weight percent of the polymer. The poly- Sperm oil. mer number average molecular weight (Mn) Spermaceti. shall be at least 2,000 (as determined by gel (xxiv) Plasticizers: permeation chromatography). The acid number of the polymer shall be less than Acetyl tributyl citrate. 250. The monomer content shall be less Acetyl triethyl citrate. than 0.5 percent. The polymers are for use Butyl phthalyl butyl glycolate. only in contact with food of Types IV–A, V, Butyl stearate. VII in table 1 of paragraph (d) of this sec- p-tert-Butyl phenyl salicylate. tion, under use conditions E through G in Dibutyl sebacate. table 2 of paragraph (d), and with food of Diethyl phthalate.
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Diisobutyl adipate. Paraffin, Type II. Diisooctyl phthalate. Petrolatum. Epoxidized soybean oil (iodine number max- Stearic acid. imum 14; oxirane oxygen content 6% min- imum), as the basic polymer. (xxviii) Silicones and their curing Ethyl phthalyl ethyl glycolate. catalysts: 2-Ethylhexyl diphenyl phosphate. (a) Silicones as the basic polymer: di-2-Ethylhexyl phthalate. Glycerol. Siloxane resins originating from methyl hy- Glyceryl monooleate. drogen polysiloxane, dimethyl Glyceryl triacetate. polysiloxane, and methylphenyl Monoisopropyl citrate. polysiloxane. Propylene glycol. Siloxane resins originating from the plat- Sorbitol. inum-catalyzed reaction product of vinyl- Mono-, di-, and tristearyl citrate. containing dimethylpolysiloxane (CAS Triethyl citrate. Reg. No. 68083–18–1 and CAS Reg. No. 68083– Triethylene glycol. 19–2) with methylhydrogen polysiloxane 3-(2-Xenolyl)-1,2-epoxypropane. (CAS Reg. No. 63148–57–2) and dimethylmethylhydrogen polysiloxane (xxv) Release agents, as the basic (CAS Reg. No. 68037–59–2), where the plat- polymer, when applicable: inum content does not exceed 150 parts per N,N′-Dioleoylethylenediamine (CAS Reg. No. million. The following substances may be 110–31–6) for use only in ionomeric resins used as optional polymerization inhibitors: complying with § 177.1330 of this chapter 3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. and in ethylene vinyl acetate copolymers 107–54–0), at a level not to exceed 0.53 complying with § 177.1350 of this chapter at weight-percent; a level not to exceed 0.0085 milligram per 1-Ethynylcyclohexene (CAS Reg. No. 931–49– square centimeter (0.055 milligram per 7), at a level not to exceed 0.64 weight-per- square inch) in the finished food-contact cent; article. Bis(methoxymethyl)ethyl maleate (CAS Reg. N,N′-Distearoyl ethylenediamine. No. 102054–10–4), at a level not to exceed 1.0 Linoleic acid amide. weight-percent; Oleic acid amide. Methylvinyl cyclosiloxane (CAS Reg. No. Palmitic acid amide. 68082–23–5); and Petrolatum. 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 methyl- loxane resins solids): phenylpolysiloxanes contain not more than 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 with § 178.3297 of this chapter. D1243–79, ‘‘Standard Test Method for Dilute (xxvii) Surface lubricants: Solution Viscosity of Vinyl Chloride Poly- mers,’’ which is incorporated by reference Cottonseed oil and other edible oils. (copies may be obtained from the Amer- Dibutyl sebacate. ican Society for Testing Materials, 1916 Dioctyl sebacate. Race St., Philadelphia, PA 19103, or may be Glyceryl monostearate. examined at the Office of the Federal Reg- Lanolin. ister, 800 North Capitol Street, NW., suite Mineral oil, white. 700, Washington, DC 20408), for use only as Palm oil. a suspending agent in the manufacture of Paraffin, Type I. vinyl chloride copolymers and limited to
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use at levels not to exceed 0.1 percent by Tri (mixed mono- and dinonylphenyl) weight of the copolymers. phosphite. Sodium dioctyl sulfosuccinate. Zinc dibutyldithiocarbamate. Sodium dodecylbenzenesulfonate Sodium lauryl sulfate. (xxxii) Side seam cements: In addi- 2,4,7,9-Tetramethyl-5-decyn-4,7-diol (C.A.S. tion to the substances listed in para- Reg. No. 126-86-3), for use only in can coat- graph (b)(3) (i) to (xxx), inclusive, of ings which are subsequently dried and this section, the following may be used. cured at temperatures of at least 193 °C (380 °F) for 4 minutes. p-tert-Butyl perbenzoate as a catalyst for epoxy resin. (xxx) Antioxidants: epsilon-Caprolactam-(ethylene-ethyl acry- late) graft polymer. Butylated hydroxyanisole. Dicumyl peroxide for use only as polymeriza- Butylated hydroxytoluene. tion catalyst. Gum guaiac. 4–(Diiodomethylsulfonyl) toluene (CAS Reg. Dilauryl thiodipropionate. No. 20018–09–1) for use as a preservative at Nordihydroguaiaretic acid. a level not to exceed 0.3 percent by weight Propyl gallate. in can–sealing cements. Distearyl thiodipropionate. Diisodecyl phthalate for use only as plasti- Thiodipropionic acid. cizer in side seam cements for containers 2,4,5-Trihydroxybutyrophenone. intended for use in contact with food only (xxxi) Can end cements (sealing com- of the types identified in paragraph (d) of pounds used for sealing can ends only): this section, table 1, under Categories I, II, In addition to the substances listed in and VI. 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 of the cement solids in can end cements. Polyamides consisting of the following: Butadiene-styrene-fumaric acid copolymer. Copolymer of omega-laurolactam and 4,4′-Butylidenebis (6-tert-butyl-m-cresol). espilon-caprolactam, CAS Reg. No. 25191– Dibenzamido phenyl disulfide. 04–2 (Nylon 12/6). Di-β-naphthyl phenylenediamine. Homopolymer of omega-aminododecanoic Dipentamethylene thiuram tetrasulfide. acid, CAS Reg. No. 24937–16–4. Isobutylene-isoprene-divinylbenzene copoly- Homopolymer of omega-laurolactam, CAS mers for use only at levels not to exceed 15 Reg. No. 25038–74–8 (Nylon 12). percent by weight of the dry cement com- Polyamides derived from the following acids position. and amines: Naphthalene sulfonic acid-formaldehyde con- Acids: densate, sodium salt, for use only at levels Adipic. not to exceed 0.6 percent by weight of the Azelaic. cement solids in can end cements for con- Sebacic. tainers having a capacity of not less than Vegetable oil acids (with or without 5 gallons. dimerization). 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).
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Triethylene glycol methacrylate for use only spectively, manufactured from methyl-3- as polymerization cross-linking agent in mercaptopropionate (CAS Reg. No. 2935–90– side seam cements for containers intended 2) and optionally containing magnesium for use in contact with food only of the nitrate (CAS Reg. No. 10377–60–3) at a con- types identified in paragraph (d) of this centration equivalent to the isothiazolone section, table 1, under Categories I, II, and active ingredients (weight/weight). For use VI. only as an antimicrobial agent in emul- Urea. sion-based silicone coatings at a level not (xxxiii) Miscellaneous materials: to exceed 50 milligrams per kilogram (based on isothiazolone active ingredient) Ammonium citrate. in the coating formulations. Ammonium potassium phosphate. Cyclohexanone-formaldehyde resin produced Bentonite, modified by reaction with benzyl when 1 mole of cyclohexanone is made to dimethyl alkyl ammonium chloride, where react with 1.65 moles of formaldehyde such the alkyl groups are derived from hydro- that the finished resin has an average mo- genated tallow (CAS Reg. No. 71011–24–0). lecular weight of 600–610 as determined by For use only as a rheological agent in coat- ASTM method D2503–82, ‘‘Standard Test ings intended to contact food under re- Method for Molecular Weight (Relative peated use conditions. Molecular Mass) of Hydrocarbons by Ther- Bentonite, modified by reaction with sodium moelectric Measurement of Vapor Pres- stearate and benzyl dimethyl alkyl ammo- sure,’’ which is incorporated by reference. nium chloride, where the alkyl groups are Copies may be obtained from the American derived from hydrogenated tallow (CAS Society for Testing Materials, 1916 Race Reg. No. 121888–68–4). For use as a St., Philadelphia, PA 19103, or may be ex- 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 polyamide derived from ethylenediamine, Hectorite, modified by reaction with a mix- sebacic acid and 12-hydroxystearic acid, for ture of benzyl methyl dialkyl ammonium use only in coatings at a level not to ex- chloride and dimethyl dialkyl ammonium ceed 3.2 percent by weight of the resin chloride, where the alkyl groups are de- when such coatings are intended for re- rived from hydrogenated tallow (CAS Reg. peated use in contact with foods only of No. 121888–67–3). For use as a rheological the types identified in paragraph (d) of this agent only in coatings intended to contact section, table 1, under Types I, II, and III, dry food under repeated-use conditions. under conditions of use C, D, E, or F as de- Lauryl alcohol. scribed in table 2 of paragraph (d) of this Lecithin. section; or when such coatings are in- Magnesium, sodium, and potassium citrate. tended for repeated use in contact with Magnesium glycerophosphate. foods of the types identified in paragraph Magnesium stearate. (d) of this section, table 1, under Types V, Mono-, di-, and tricalcium phosphate. VI, VII, and VIII, under conditions of use E Monodibutylamine pyrophosphate as or F as described in table 2 of paragraph (d) sequestrant for iron. of this section. Use shall be limited to Mono-, di-, and trimagnesium phosphate. coatings for tanks of capacity greater than Myristyl alcohol. 530,000 gallons. Octyl alcohol. Castor oil, sulfated, sodium salt (CAS Reg. Phosphoric acid. No. 68187–76–8), for use only in coatings for Polybutene, hydrogenated; complying with containers intended for repeated use. the identity and limitations prescribed by Cetyl alcohol. § 178.3740 of this chapter. 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Poly(ethylene oxide). Reg. No. 26172–55–4) and 2-methyl-4- Siloxanes and silicones, dimethyl, 3- isothiazolin-3-one (CAS Reg. No. 2682–20–4) hydroxypropyl group-terminated, diesters mixture, at a ratio of 3 parts to 1 part, re- with poly(2-oxepanone), diacetates (CAS
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Reg. No. 116810–47–0) at a level not to ex- in coatings that contact food at tem- ceed 0.025 weight percent of the finished peratures not to exceed room tempera- coating having no greater than a 0.5 mil ture provided that the concentration of thickness for use as a component of poly- the polyamide resins in the finished ester, epoxy, and acrylic coatings com- plying with paragraphs (b)(3)(vii), (viii), food-contact coating does not exceed 5 and (xx) of this section, respectively. milligrams per square inch of food-con- Silver chloride-coated titanium dioxide for tact surface. use only as a preservative in latex emul- (xxxvi) Methacrylonitrile grafted sions at a level not to exceed 2.2 parts per polybutadiene copolymers containing million (based on silver ion concentration) no more than 41 weight percent of total in the dry coating. polymer units derived from Sodium pyrophosphate. Stannous chloride. methacrylonitrile; for use only in coat- Stannous stearate. ings that are intended for contact, Stannous sulfate. under conditions of use D, E, F, or G Stearyl alcohol. described in table 2 of paragraph (d) of 2-Sulfoethyl methacrylate, sodium salt (CAS this section, with food containing no Reg. No. 1804–87–1). For use only in copoly- more than 8 percent of alcohol. mer coatings on metal under conditions of (xxxvii) Polymeric resin as a coating use E, F, and G described in table 2 of para- graph (d) of this section, and limited to use component prepared from terephthalic at a level not to exceed 2.0 percent by acid, isophthalic acid, succinic anhy- weight of the dry copolymer coating. dride, ethylene glycol, diethylene gly- Tetrasodium pyrophosphate. col, and 2,2-dimethyl-1,3-propanediol 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
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as determined by the methods provided (4) From coating intended for re- in paragraph (e) of this section. peated use, and employed other than as (2) From a coating intended for or a component of a container, not to ex- employed as a component of a con- ceed 18 milligrams per square inch of tainer having a capacity in excess of 1 coated surface. gallon and intended for one-time use, (d) Tables: not to exceed 1.8 milligrams per square inch nor to exceed that amount as mil- TABLE 1—TYPES OF FOOD ligrams per square inch that would I. Nonacid (pH above 5.0), aqueous products; may contain equal 0.005 percent of the water capac- salt or sugar or both, and including oil-in-water emulsions ity of the container in milligrams, di- of low- or high-fat content. vided by the area of the food-contact II. Acidic (pH 5.0 or below), aqueous products; may contain salt or sugar or both, and including oil-in-water emulsions surface of the container in square of low- or high-fat content. inches. III. Aqueous, acid or nonacid products containing free oil or (3) From a coating intended for or fat; may contain salt, and including water-in-oil emulsions employed as a component of a con- of low- or high-fat content. tainer for repeated use, not to exceed IV. Dairy products and modifications: 18 milligrams per square inch nor to A. Water-in-oil emulsion, high- or low-fat. B. Oil-in-water emulsion, high- or low-fat. exceed that amount as milligrams per V. Low moisture fats and oils. square inch that would equal 0.005 per- VI. Beverages: cent of the water capacity of the con- A. Containing alcohol. tainer in milligrams, divided by the B. Nonalcoholic. area of the food-contact surface of the VII. Bakery products. container in square inches. 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, IVÐB ...... 250 °F, 2 hr ...... (e.g., over 212 °F). III, IVÐA, 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, IVÐB ...... Fill boiling, cool to ...... °F. 100 °F. III, IVÐA ...... do ...... V ...... 120 °F, 15 min...... do ...... D. Hot filled or pasteurized below 150 II, IVÐB, VIÐB ...... 150 °F, 2 hr ...... °F. III, IVÐA ...... do ...... 100 °F, 30 min. 150 °F, 2 hr V ...... do ...... VIÐA ...... E. Room temperature filled and stored I, II, IVÐB, VIÐB ..... 120 °F, 24 hr ...... (no thermal treatment in the con- III, IVÐA ...... do ...... 70 °F, 30 min. 120 °F, 24 hr tainer). V, VII ...... do ...... VIÐA ...... F. Refrigerated storage, no thermal I, II, III, IVÐA, IVÐB, 70 °F, 48 hr ...... treatment in the container). VIÐB, VII. 70 °F, 48 hr VIÐA ...... G. Frozen storage (no thermal treat- I, II, III, IVÐB, VII ... 70 °F, 24 hr ...... ment in the container). H. Frozen storage: Ready-prepared foods intended to be reheated in con- tainer at time of use:. 1. Aqueous or oil in water emulsion I, II, IVÐB ...... 212 °F, 30 min. of high or low fat. 2. Aqueous, high or low free oil or III, IVÐA, 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.
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(e) Analytical methods—(1) Selection of perature of 190 °F–200 °F before starting extractability conditions. First ascertain to rinse the container. Invert the con- the type of food product (table 1, para- tainer over the top of the fountain and graph (d) of this section) that is being direct a strong stream of hot water packed commercially in the test con- against the bottom and all sides for 1 tainer and the normal conditions of minute, drain, and allow to dry. thermal treatment used in packaging (4) Exposure conditions—(i) Water (250 the type of food involved. Using table 2 °F for 2 hours), simulating high-tempera- (paragraph (d) of this section), select ture heat sterilization. Fill the container the food-simulating solvent or solvents within 1⁄4-inch of the top with a meas- (demineralized distilled water, ured volume of demineralized distilled heptane, and/or 8 percent ethyl alcohol) water. Cover the container with clean and the time-temperature exaggera- aluminum foil and place the container tions of the container-use conditions. on a rack in a pressure cooker. Add a Aqueous products (Types I, II, IV–B, small amount of demineralized dis- and VI–B) require only a water- tilled water to the pressure cooker, but extractability test at the temperature do not allow the water to touch the and time conditions shown for the bottom of the container. Close the most severe ‘‘conditions of use.’’ Aque- cooker securely and start to heat over ous products with free oil or fat, and a suitable burner. When a steady water-oil emulsions (types III, IV–A, stream of steam emerges from the and VII) will require determinations of vent, close the vent and allow the pres- both water extractability and heptane sure to rise to 15 pounds per square extractability. Low-moisture fats and inch (250 °F) and continue to maintain 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 (iii) Water (from boiling to 100 °F), sim- diameter metal tube attached to a hot ulating hot fill or pasteurization above 150 water line and bent so as to direct a °F. Fill the container within 1⁄4-inch of stream of water upward, may be used. the top with a measured volume of Be sure hot water has reached a tem- boiling, demineralized distilled water.
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Insert a thermometer in the water and (vii) Water (70 °F for 24 hours), simu- allow the uncovered container to stand lating frozen storage. Bring in a room at 70 °F–85 °F. When the tem- demineralized distilled water to 70 °F perature reads 100 °F, composite the in a clean Pyrex flask. Fill the con- water from each replicate immediately tainer within 1⁄4-inch of the top with a in a clean Pyrex flask or beaker. Pro- measured volume of the 70 °F water ceed with the determination of the and cover with clean aluminum foil. amount of extractives by the method Place the container in a suitable room described in paragraph (e)(5) of this maintained at 70 °F. After 24 hours, im- section. mediately composite the water of each (iv) Water (150° for 2 hours), simulating replicate in a clean Pyrex flask or hot fill or pasteurization below 150 °F. beaker. Proceed with the determina- Preheat demineralized distilled water tion of the amount of extractives by to 150 °F in a clean Pyrex flask. Fill the method described in paragraph (e)(5) of this section. the container within 1⁄4-inch of the top ° with a measured volume of the 150 °F (viii) Water (212 F for 30 minutes), sim- water and cover with clean aluminum ulating frozen foods reheated in the con- 1 foil. Place the test container in an tainer. Fill the container to within ⁄4- oven maintained at 150 °F. After 2 inch of the top with a measured volume hours, remove the test container from of boiling, demineralized distilled the oven and immediately composite water. Cover the container with clean the water of each replicate in a clean aluminum foil and place the container on a rack in a pressure cooker in which Pyrex flask or beaker. Proceed with a small amount of demineralized dis- 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- 1 Fill the container within ⁄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, danger of explosion. Fill the test con- and cover with clean aluminum foil. tainer within 1⁄4-inch of the top with a Place the test container in a suitable measured volume of the 150 °F heptane room maintained at 70 °F. After 48 and cover with clean aluminum foil. hours, immediately composite the Place the test container in the water of each replicate in a clean preheated pressure cooker and then put Pyrex flask or beaker. Proceed with the assembly into a 150 °F incubator. the determination of the amount of ex- After 2 hours, remove the pressure tractives by the method described in cooker from the incubator, open the as- paragraph (e)(5) of this section. sembly, and immediately composite
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the 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- (xii) Heptane (100 °F for 30 minutes), tractives by the method described in simulating hot fill or pasteurization below paragraph (e)(5) of this section. 150 °F for fatty foods only. Preheat re- (x) Heptane (120 °F for 30 minutes), sim- distilled reagent-grade heptane (boiling ulating boiling water sterilization of fatty point 208 °F) carefully in a clean Pyrex foods only. Preheat redistilled reagent- flask on a water bath or nonsparking grade heptane (boiling point 208 °F) hot plate in a well-ventilated hood to carefully in a clean Pyrex flask on a 100 °F. At the same time, preheat a water bath or nonsparking hot plate in pressure cooker or equivalent to 100 °F a well-ventilated hood to 120 °F. At the in an incubator. This pressure cooker same time, preheat a pressure cooker is to serve only as a container for the or equivalent to 120 °F in an incubator. heptane-containing test package inside This pressure cooker is to serve only as the incubator in order to minimize the a vented container for the heptane-con- danger of explosion. Fill the test con- taining test package inside the incu- tainer within 1⁄4-inch of the top with a bator in order to minimize the danger measured volume of the 100 °F heptane of explosion. Fill the test container and cover with clean aluminum foil. within 1⁄4-inch of the top with a meas- Place the test container in the ured volume of the 120 °F heptane and preheated pressure cooker and then put cover with clean aluminum foil. Place the assembly into a 100 °F incubator. the test container in the preheated After 30 minutes, remove the pressure pressure cooker and then put the as- cooker from the incubator, open the as- sembly 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
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heptane and cover with clean alu- maintained at 70 °F. After 48 hours, im- minum foil. Place the test container in mediately composite the alcohol from the preheated pressure cooker and then each replicate into a clean Pyrex flask. put the assembly into a 120 °F incu- Proceed with the determination of the bator. After 30 minutes, remove the amount of extractives by the method pressure cooker from the incubator, described in paragraph (e)(5) of this open the assembly and immediately section. composite the heptane from each rep- NOTE: The tests specified in paragraph licate into a clean Pyrex flask. Proceed (e)(4) (i) through (xvii) of this section are ap- with the determination of the amount plicable to flexible packages consisting of of extractives by the method described coated metal contacting food, in which case in paragraph (e)(5) of this section. the closure end is double-folded and clamped (xv) Alcohol—8 percent (150 °F for 2 with metal spring clips by which the package hours), simulating alcoholic beverages hot can be suspended. filled or pasteurized below 150 °F. Pre- (5) Determination of amount of extrac- heat 8 percent (by volume) ethyl alco- tives—(i) Total residues. Evaporate the hol in demineralized distilled water to food-simulating solvents from para- 150 °F in a clean Pyrex flask. Fill the graph (e)(4) (i) to (xvii), inclusive, of test container with within 1⁄4-inch of this section to about 100 milliliters in the top with a measured volume of the the Pyrex flask and transfer to a clean, 8 percent alcohol. Cover the container tared platinum dish, washing the flask with clean aluminum foil and place in three times with the solvent used in an oven maintained at 150 °F. After 2 the extraction procedure, and evapo- 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 per square inch clean aluminum foil and place in an 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 amount of extractives by the method Milligrams extractives = e 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 ()()()csF volume) ethyl alcohol in demineralized distilled water to 70 °F in a clean Pyrex where: Ex=Extractives residue in ppm for any con- flask. Fill the test container within 1⁄4- tainer size. inch of the top with a measured volume e=Milligrams extractives per sample test- of the 8 percent alcohol. Cover the con- ed. tainer with clean aluminum foil. Place a=Total coated area, including closure in the test container in a suitable room square inches.
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c=Water capacity of container, in grams. extractives (‘‘C’’ enamels only): Ash s=Surface of coated area tested, in square the residue in the platinum dish by inches. heating gently over a Meeker-type F=Five, the ratio of the amount of extrac- tives removed from a coated container burner to destroy organic matter and by heptane under exaggerated time- hold at red heat for about 1 minute. temperature test conditions compared Cool in the air for 3 minutes, and place to the amount extracted by a fat or oil the platinum dish in the desiccator for from a container tested under exagger- 30 minutes and weigh to the nearest 0.1 ated conditions of thermal sterilization milligram. Analyze this ash for zinc by and use. standard Association of Official Agri- e′=Chloroform-soluble extractives residue. ee′=Zinc corrected chloroform-soluble ex- cultural Chemists methods or equiva- tractive residue. lent. Calculate the zinc in the ash as e′ or ee′ is substituted for e in the above zinc oleate, and subtract from the equations when necessary. weight of chloroform-soluble extrac- tives residue (e′) to obtain the zinc-cor- If when calculated by the equations in rected chloroform-soluble extractives paragraph (e)(5)(i) (a) and (b) of this residue (ee′). This ee′ is substituted for section, the concentration of extrac- e in the formulas in paragraph (e)(5)(i) tives residue (Ex) exceeds 50 parts per million or the extractives in milli- (a) and (b) of this section. To comply grams per square inch exceed the limi- with the limitations in paragraph (c) of tations prescribed in paragraph (c) of this section, the chloroform-soluble ex- this section for the particular con- tractives residue (but after correction tainer size, proceed to paragraph for the zinc extractives in case of ‘‘C’’ (e)(5)(ii) of this section (method for de- enamels) must not exceed 50 parts per termining the amount of chloroform- million and must not exceed in milli- soluble extractives residue). grams per square inch the limitations (ii) Chloroform-soluble extractives res- for the particular article as prescribed idue. Add 50 milliliters of chloroform in paragraph (c) of this section. (freshly distilled reagent grade or a (f) Equipment and reagent require- grade having an established consist- ments—(1) Equipment. ently low blank) to the dried and Rinsing equipment, soda fountain pressure- weighed residue, (e), in the platinum type hot water, consisting in simplest form dish, obtained in paragraph (e)(5)(i) of of a 1⁄8-inch–1⁄4-inch inside diameter metal this section. Warm carefully, and filter tube attached to a hot water line delivering through Whatman No. 41 filter paper in 190 °F–200 °F water and bent so as to direct a Pyrex funnel, collecting the filtrate a stream of water upward. in a clean, tared platinum dish. Repeat Pressure cooker, 21-quart capacity with the chloroform extraction, washing the pressure gage, safety release, and removable filter paper with this second portion of rack, 12.5 inches inside diameter × 11 inches chloroform. Add this filtrate to the inside height, 20 pounds per square inch safe original filtrate and evaporate the operating pressure. total down to a few milliliters on a Oven, mechanical convection, range to in- clude 120 °F–212 °F explosion-proof, inside di- low-temperature hotplate. The last few mensions (minimum), 19′′ × 19′′ × 19′′, con- milliliters should be evaporated in an stant temperature to ±2 °F (water bath may oven maintained at 212 °F. Cool the be substituted). platinum dish in a desiccator for 30 Incubator, inside dimensions (minimum) minutes and weigh to the nearest 0.1 19′′ × 19′′ × 19′′ for use at 100 °F±2 °F explosion milligram to get the chloroform-solu- proof (water bath may be substituted). ble extractives residue (e′). This e′ is Constant-temperature room or chamber 70 substituted for e in the equations in °F±2 °F minimum inside dimensions 19′′ × 19′′ paragraph (e)(5)(i) (a) and (b) of this × 19′′. section. If the concentration of extrac- Hot plate, nonsparking (explosion proof), tives (Ex) still exceeds 50 parts per mil- top 12′′ × 20′′, 2,500 watts, with temperature lion or the extractives in milligrams control. per square inch exceed the limitations Platinum dish, 100-milliliter capacity min- imum. prescribed in paragraph (c) of this sec- All glass, Pyrex or equivalent. tion for the particular container size, proceed as follows to correct for zinc (2) Reagents.
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Water, all water used in extraction proce- § 175.320 Resinous and polymeric coat- dure should be freshly demineralized (deion- ings for polyolefin films. ized) distilled water. Heptane, reagent grade, freshly redistilled Resinous and polymeric coatings before use, using only material boiling at 208 may be safely used as the food-contact °F. surface of articles intended for use in Alcohol, 8 percent (by volume), prepared producing, manufacturing, packing, from undenatured 95 percent ethyl alcohol processing, preparing, treating, pack- diluted with demineralized or distilled aging, transporting, or holding food, in water. accordance with the following pre- Chloroform, reagent grade, freshly redis- scribed conditions: tilled before use, or a grade having an estab- (a) The coating is applied as a contin- lished, consistently low blank. uous film over one or both sides of a Filter paper, Whatman No. 41 or equiva- base film produced from one or more of lent. the basic olefin polymers complying (g) In accordance with good manufac- with § 177.1520 of this chapter. The base turing practice, finished coatings in- polyolefin film may contain optional tended for repeated food-contact use adjuvant substances permitted for use in polyolefin film by applicable regula- shall be thoroughly cleansed prior to tions in parts 170 through 189 of this their first use in contact with food. chapter. (h) Acrylonitrile copolymers identi- (b) The coatings are formulated from fied in this section shall comply with optional substances which are: the provisions of § 180.22 of this chap- (1) Substances generally recognized ter. as safe for use in or on food. [42 FR 14534, Mar. 15, 1977] (2) Substances the use of which is permitted under applicable regulations EDITORIAL NOTE: For FEDERAL REGISTER ci- in parts 170 through 189 of this chapter, tations affecting § 175.300, see the List of CFR by prior sanctions, or approvals. Sections Affected, which appears in the (3) Substances identified in this para- Finding Aids section of the printed volume graph (b)(3) and subject to such limita- and on GPO Access. 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 sty- rene and/or methacrylic acid, and the copolymer subse- quently 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 meth- acrylate, 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 molec- ular weight 900. Melamine-formaldehyde as the basic polymer or chemi- cally modified with methyl alcohol. Methacrylic acid and its ethyl or methyl esters copolym- erized with one or more of the following: Acrylic acid. Ethyl acrylate. Methyl acrylate. α-Methyl styrene polymer. α-Methylstyrene-vinyltoluene copolymer resins (molar ratio For use only in coatings that contact food under conditions of 1 α-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 α-methylstyrene- vinyltoluene copolymer resins in the finished food-contact coating does not exceed 1.0 milligram per square inch of food-contact surface.
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List of substances Limitations
Petroleum alicyclic hydrocarbon resins ...... As defined in ¤ 176.170 of this chapter. Blended with butyl rub- ber 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 coat- ing solids. Polyamide resins (CAS Reg. No. 68139Ð70Ð8), 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. 123Ð99Ð9) in an amount not to exceed 3.7 percent by weight of the poly- amide resin. Ethylenediamine (CAS Reg. No. 107Ð15Ð3). Piperazine (CAS Reg. No. 110Ð85Ð0) in an amount not to exceed 6.4 percent by weight of the poly- amide resin. 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 condi- tions 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 chap- ter, table 1, under Category VIII, and under conditions of use E, F, or G described in table 2 of ¤ 176.170(c) of this chap- ter. Polyhydric alcohols: 1,3-Butylene glycol. Diethylene glycol. 2,2-Dimethyl-1,3-propanediol. Dipropylene glycol. Ethylene glycol. Glycerol. Mannitol. α-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 ......
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List of substances Limitations
Siloxanes and silicones: platinum-catalyzed reaction product of Platinum content not to exceed 150 parts per million. vinyl-containing dimethylpolysiloxane (CAS Reg. No. 68083Ð 18Ð1 and CAS Reg. No. 68083Ð19Ð2) with methylhydrogen polysiloxane (CAS Reg. No. 63148Ð57Ð2) and dimethylmethylhydrogen polysiloxane (CAS Reg. No. 68037Ð 59Ð2). The following substances may be used as optional polymerization inhibitors:. 3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. 107Ð54Ð0), at a level not to exceed 0.53 weight percent;. 1-Ethynylcyclohexene (CAS Reg. No. 931Ð49Ð7), at a level not to exceed 0.64 weight percent;. Bis(methoxymethyl)ethyl maleate (CAS Reg. No. 102054Ð10Ð4), at a level not to exceed 1.0 weight percent;. Methylvinyl cyclosiloxane (CAS Reg. No. 68082Ð23Ð5); and. Tetramethyltetravinylcyclotetrasiloxane (CAS Reg. No. 2554Ð06Ð5).. 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: 68083Ð19Ð2 and 68083Ð18Ð1), with methyl hydrogen 1. In coatings for olefin polymers provided the coating contacts polysiloxane (CAS Reg. No. 63148Ð57Ð2). Dimethyl maleate food only of the types identified in ¤ 176.170(c) of this chap- (CAS Reg. No. 624Ð48Ð6) and vinyl acetate (CAS Reg. No. ter, table 1, under Types I, II, VI, and VIIÐB when used 108Ð05Ð4) 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 chap- ter, table 1, under Types III, IV, V, VIIÐA, 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. 68083Ð19Ð2 and 68083Ð18Ð1), with methyl hydrogen polysiloxane (CAS Reg. No. 63148Ð57Ð2). Dimethyl maleate (CAS Reg. No. 624Ð48Ð6), vinyl acetate (CAS Reg. No. 108Ð05Ð4), dibutyl maleate (CAS Reg. No. 105Ð76Ð0) and diallyl maleate (CAS Reg. No. 999Ð21Ð3) may be used as optional polymerization inhibitors. The polymer may also contain C16ÐC18 olefins (CAS Reg. No. 68855Ð60Ð7) as a control release agent. Styrene copolymerized with one or more of the following: Acrylonitrile. α-Methyl styrene. Styrene polymers made by the polymerization of any com- For use only in contact with foods of Types IVÐA, 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, in- dividually, 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 per- meation chromatography). The acid number of the poly- mer shall be less than 250. The monomer content shall be less than 0.5 percent. Styrene-isobutylene copolymer. Terpene resins consisting of polymers of α-pinene, β-pi- nene, and/or dipentene; acid value less than 5, saponi- fication 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. 1804Ð87Ð1]. 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 ma- leic acid-modified copolymer. Vinyl chloride copolymerized with one or more of the fol- lowing: Acrvlonitrile. Vinyl acetate. Vinylidene chloride.
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List of substances Limitations
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. 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. 26172Ð For use only as an antimicrobial agent in emulsion-based sili- 55Ð4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. cone coatings at a level not to exceed 50 milligrams per kilo- 2682Ð20Ð4) 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. 2935Ð90Ð2) and optionally containing magnesium nitrate (CAS Reg. No. 10377Ð60Ð3) at a concentration equivalent to the isothiazolone active ingredients (weight/ weight).. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691Ð65Ð 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 alu- minum, ammonium, calcium, magnesium, and sodium salts. Hexane. Methyl ethyl ketone. N,N′-Dioleoylethylenediamine (CAS Reg. No. 110Ð31Ð6) .. For use only in ionomeric resins complying with ¤ 177.1330 of this chapter and in ethylene vinyl acetate copolymers com- plying with ¤ 177.1350 of this chapter at a level not to ex- ceed 0.0085 milligram per square centimeter (0.055 milli- gram 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- 87Ð100. 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 con- centration) in the dry coating.
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(c) The coating in the finished form List of substances Limitations in which it is to contact food, when ex- Silica. tracted with the solvent or solvents Japan wax. characterizing the type of food, and under conditions of time and tempera- (e) Copolymer of vinyl acetate and ture characterizing the conditions of crotonic acid used as a coating or as a its intended use as determined from ta- component of a coating conforming bles 1 and 2 of § 176.17(c) of this chapter, with the specifications of paragraph shall yield net chloroform-soluble ex- (e)(1) of this section are used as pro- tractives not to exceed 0.5 milligram vided in paragraph (e)(2) of this sec- per square inch of coated surface. tion. (d) Acrylonitrile copolymers identi- (1) Specifications. (i) The chloroform- fied in this section shall comply with soluble portion of the water extractives the provisions of § 180.22 of this chap- of the coated film obtained with dis- ter. tilled water at 120 °F for 24 hours does not exceed 0.5 milligram per square [42 FR 14534, Mar. 15, 1977, as amended at 43 inch of coated surface. FR 7206, Feb. 21, 1978; 45 FR 6541, Jan. 29, (ii) The chloroform-soluble portion of 1980; 47 FR 22512, May 25, 1982; 49 FR 36497, the n-heptane extractives of the coated Sept. 18, 1984; 50 FR 47209, Nov. 15, 1985; 56 FR ° 49674, Oct. 1, 1991; 61 FR 14246, Apr. 1, 1996; 63 film obtained with n-heptane at 70 F FR 71017, Dec. 23, 1998; 64 FR 2568, Jan. 15, for 30 minutes does not exceed 0.5 milli- 1999; 65 FR 6892, Feb. 11, 2000; 65 FR 37041, gram per square inch of coated surface. June 13, 2000] (2) Conditions of use. The copolymer of vinyl acetate and crotonic acid is § 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 copoly- mer 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- tions: (b) The quantity of any optional sub- (a) The coating is applied as a contin- stance does not exceed the amount rea- uous film over one or both sides of a sonably required to accomplish the in- base film produced from nylon resins tended physical or technical effect nor complying with § 177.1500 of this chap- any limitations further provided. ter. (c) Any optional substance that is (b) The coatings are prepared from the subject of a regulation in parts 174, vinylidene chloride copolymers pro- 175, 176, 177, 178, and § 179.45 of this duced by copolymerizing vinylidene chapter conforms with any specifica- chloride with one or more of the mono- tions in such regulation. mers acrylic acid, acrylonitrile, ethyl (d) Optional substances as provided acrylate, methacrylic acid, methyl ac- in paragraph (a) of this section include: rylate, methyl methacrylate (CAS Reg. (1) Substances generally recognized No. 80–62–6; maximum use level 6 as safe in food. weight percent) and 2-sulfoethyl meth- (2) Substances subject to prior sanc- acrylate (CAS Reg. No. 10595–80–9; max- tion or approval for uses with a copoly- imum use level 1 weight percent). The mer of vinyl acetate and crotonic acid finished copolymers contain at least 50 and used in accordance with such sanc- weight percent of polymer units de- tion or approval. rived from vinylidene chloride. The fin- (3) Substances identified in this sub- ished coating produced from vinylidene paragraph and subject to such limita- chloride copolymers produced by co- tions as are provided: polymerizing vinylidene chloride with
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methyl methacrylate and/or 2- dodecylbenzenesulfonate in addition to sulfoethyl methacrylate, or with meth- substances described in § 174.5(d) of this yl methacrylate and/or 2-sulfoethyl chapter. methacrylate together with one or (d) The coating in the finished form more of the other monomers from this in which it is to contact food, when ex- section, is restricted to use at or below tracted with the solvent or solvents room temperature. characterizing the type of food, and (c) Optional adjuvant substances em- under the conditions of time and tem- ployed in the production of the coat- perature characterizing the conditions ings or added thereto to impart desired of its intended use as determined from properties may include sodium tables 1 and 2 of § 176.170(c) of this chap- dodecylbenzenesulfonate. ter, shall yield net chloroform-soluble (d) The coating in the finished form extractives in each extracting solvent in which it is to contact food, when ex- not to exceed 0.5 milligram per square tracted with the solvent or solvents inch of coated surface as determined by characterizing the type of food, and the methods described in § 176.170(d) of under conditions of time and tempera- this chapter. In testing the finished ture characterizing the conditions of food-contact articles, a separate test its intended use as determined from ta- sample is to be used for each required bles 1 and 2 of § 176.170(c) of this chap- extracting solvent. ter, shall yield net chloroform-soluble (e) Acrylonitrile copolymers identi- extractives not to exceed 0.5 milligram fied in this section shall comply with per square inch of coated surface when the provisons of § 180.22 of this chapter. tested by the methods described in § 176.170(d) of this chapter. § 175.380 Xylene-formaldehyde resins (e) Acrylonitrile copolymers identi- condensed with 4,4′- fied in this section shall comply with isopropylidenediphenol- the provisions of § 180.22 of this chap- epichlorohydrin epoxy resins. ter. The resins identified in paragraph (a) of this section may be safely used as a [42 FR 14534, Mar. 15, 1977, as amended at 43 FR 7206, Feb. 21, 1978; 45 FR 76998, Nov. 21, food-contact coating for articles in- 1980; 47 FR 54430, Dec. 3, 1982] tended for use in contact with food, in accordance with the following pre- § 175.365 Vinylidene chloride copoly- scribed conditions. mer coatings for polycarbonate (a) The resins are produced by the film. condensation of xylene-formaldehyde Vinylidene chloride copolymer coat- resin and 4,4′-isopropylidenediphenol- ings identified in this section and ap- epichlorohydrin epoxy resins, to which plied on polycarbonate film may be may have been added certain optional safely used as food-contact surfaces, in adjuvant substances required in the accordance with the following pre- production of the resins or added to im- scribed conditions: part desired physical and technical (a) The coating is applied as a contin- properties. The optional adjuvant sub- uous film over one or both sides of a stances may include resins produced by base film produced from polycarbonate the condensation of allyl ether of resins complying with § 177.1580 of this mono-, di-, or trimethylol phenol and chapter. capryl alcohol and also may include (b) The coatings are prepared from substances identified in § 175.300(b)(3), vinylidene chloride copolymers pro- with the exception of paragraph (b)(3) duced by copolymerizing vinylidene (xxxi) and (xxxii) of that section. 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
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food meets the following extractives (c) The optional substances per- limitations when tested by the meth- mitted are as follows: ods provided in § 175.300(e): (1) The coating when extracted with List of substances Limitations distilled water at 180 °F for 24 hours Ethylene glycol ...... As a solvent removed by yields total extractives not to exceed water washing. Iron oxide. 0.05 milligram per square inch of food- Lithium hydroxide ...... Removed by water washing. contact surface. Methyl orange ...... As an acid-base indicator. (2) The coating when extracted with 8 Potassium dichromate ...... Removed by water washing. percent (by volume) ethyl alcohol in Silica gel. Sodium silicate. distilled water at 160 °F for 4 hours Zinc, as particulate metal. yields total extractives not to exceed 0.05 milligram per square inch of food- (d) The coating in the finished form contact surface. in which it is to contact food, when ex- (c) The resins identified in paragraph tracted with the solvent or solvents (a) of this section may be used as a characterizing the type of food, and food-contact coating for articles in- under the conditions of its intended use tended for contact at temperatures not as shown in table 1 and 2 of § 175.300(d) to exceed room temperature with food (using 20 percent alcohol as the solvent of Type VI–C described in table 1 of when the type of food contains approxi- § 176.170(c) of this chapter provided the mately 20 percent alcohol) shall yield coating in the finished form in which it total extractives not to exceed those is to contact food meets the following prescribed in § 175.300(c)(3); lithium ex- 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 may be safely used as the food-contact Subpart B—Substances for Use Only as surface of articles intended for use in Components of Paper and Paperboard producing, manufacturing, packing, Sec. processing, preparing, treating, pack- 176.110 Acrylamide-acrylic acid resins. aging, transporting, or holding food, 176.120 Alkyl ketene dimers. subject to the provisions of this sec- 176.130 Anti-offset substances. tion; 176.150 Chelating agents used in the manu- (a) The coating is applied to a metal facture of paper and paperboard. 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 optional substances which include: in contact with aqueous and fatty foods. (1) Substances generally recognized 176.180 Components of paper and paperboard as safe. in contact with dry food. (2) Substances for which safe condi- 176.200 Defoaming agents used in coatings. tions of use have been prescribed in 176.210 Defoaming agents used in the manu- 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- limitations prescribed. hydroxyhexadecane.
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176.260 Pulp from reclaimed fiber. ketones do not exceed 0.4 percent by 176.300 Slimicides. weight of the paper or paperboard. 176.320 Sodium nitrate-urea complex. (c) The alkyl ketene dimers may be 176.350 Tamarind seed kernel powder. used in the form of an aqueous emul- AUTHORITY: 21 U.S.C. 321, 342, 346, 348, 379e. sion which may contain sodium SOURCE: 42 FR 14554, Mar. 15, 1977, unless lignosulfonate as a dispersant. otherwise noted. § 176.130 Anti-offset substances. EDITORIAL NOTE: Nomenclature changes to part 176 appear at 61 FR 14482, Apr. 2, 1996. Substances named in paragraphs (b) and (c) of this section may be safely Subpart A [Reserved] used to prevent the transfer of inks employed in printing and decorating paper and paperboard used for food Subpart B—Substances for Use packaging in accordance with the pro- Only as Components of Paper visions of this section: and Paperboard (a) The substances are applied to the nonfood contact, printed side of the § 176.110 Acrylamide-acrylic acid res- paper or paperboard in an amount not ins. greater than that required to accom- Acrylamide-acrylic acid resins may plish the technical effect nor greater be safely used as components of arti- than any specific limitations, where cles intended for use in producing, such are provided. manufacturing, packing, processing, (b) Anti-offset powders are prepared preparing, treating, packaging, trans- from substances that are generally rec- porting, or holding food, subject to the ognized as safe in food, substances for provisions of this section. which prior sanctions or approvals (a) Acrylamide-acrylic acid resins are were granted and which are used in ac- produced by the polymerization of ac- cordance with the specific provisions of rylamide with partial hydrolysis or by such sanction or approval, and sub- the copolymerization of acrylamide stances named in paragraph (c) of this and acrylic acid. section. (b) The acrylamide-acrylic acid res- (c) The substances permitted are as ins contain less than 0.2 percent resid- follows: ual monomer. (c) The resins are used as adjuvants Substances Limitations in the manufacture of paper and paper- Carbon tetrachloride. board in amounts not to exceed that Methyl hydrogen necessary to accomplish the technical polysiloxanes. Industrial starch—modified .... Complying with ¤ 178.3520 of effect and not to exceed 2 percent by this chapter. weight of the paper or paperboard. 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. paper and paperboard under such condi- Disodium ethylenediamine tetraacetate. Pentasodium salt of diethylenetriamine tions that the alkyl ketene dimers and pentaacetate. their hydrolysis products dialkyl Sodium fructoheptonate.
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List of substances Limitations the uncoated or coated food-contact surface of paper and paperboard in- Sodium glucoheptonate. Tetrasodium ethylenediamine tetra- tended for use in producing, manufac- acetate. turing, packaging, processing, pre- Trisodium N-hydroxyethyl ethylene- paring, treating, packing, transporting, diamine triacetate. or holding aqueous and fatty foods, (b) Any one or any combination of subject to the provisions of this sec- the substances named is used or in- tion. Components of paper and paper- tended for use as chelating agents. board in contact with dry food of the (c) The substances are added in an type identified under Type VIII of table amount not greater than that required 1 in paragraph (c) of this section are to accomplish the intended technical subject to the provisions of § 176.180. effect nor greater than any specific (a) Substances identified in para- limitation, where such is provided. graph (a) (1) through (5) of this section may be used as components of the food- § 176.160 Chromium (Cr III) complex of N-ethyl-N-heptadecylfluoro-oc- contact surface of paper and paper- tane sulfonyl glycine. board. Paper and paperboard products The chromium (Cr III) complex of N- shall be exempted from compliance ethyl - N -heptadecylfluoro-octane with the extractives limitations pre- sulfonyl glycine containing up to 20 scribed in paragraph (c) of this section: percent by weight of the chromium (Cr Provided, That the components of the III) complex of heptadecylfluoro-octane food-contact surface consist entirely of sulfonic acid may be safely used as a one or more of the substances identi- component of paper for packaging dry fied in this paragraph: And provided fur- food when used in accordance with the ther, That if the paper or paperboard following prescribed conditions. when extracted under the conditions (a) The food additive is used as a prescribed in paragraph (c) of this sec- component of paper in an amount not tion exceeds the limitations on extrac- to exceed 0.5 percent by weight of the tives contained in paragraph (c) of this paper. section, information shall be available (b)(1) The food-contact surface of the from manufacturing records from paper is overcoated with a polymeric or which it is possible to determine that resinous coating at least 1⁄3-mil in only substances identified in this para- thickness, that meets the provision of graph (a) are present in the food-con- § 176.170; or (2) The treated paper forms one or tact surface of such paper or paper- more plies of a paper in a multiwall board. bag and is separated from the food by (1) Substances generally recognized at least one ply of packaging films or as safe in food. grease-resistant papers which serves as (2) Substances generally recognized a functional barrier between the food as safe for their intended use in paper additive and the food. Such packaging and paperboard products used in food films or grease-resistant papers con- packaging. form with appropriate food additive (3) Substances used in accordance regulations. with a prior sanction or approval. (c) The labeling of the food additive (4) Substances that by regulation in shall contain adequate directions for parts 170 through 189 of this chapter its use to insure compliance with the may be safely used without extractives requirements of paragraphs (a) and (b) limitations as components of the of this section. uncoated or coated food-contact sur- § 176.170 Components of paper and pa- face of paper and paperboard in contact perboard in contact with aqueous with aqueous or fatty food, subject to and fatty foods. the provisions of such regulation. Substances identified in this section (5) Substances identified in this para- may be safely used as components of graph, as follows:
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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-β-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 β-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. 86830Ð15Ð1). 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. 40623Ð75Ð4) 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 75Ð150 centipoises at 25 °C as deter- mined 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 22.5Ð25.0 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 per- cent by weight aqueous solution has a viscosity of 1,000Ð 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 7.4Ð8.3 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 paper- board 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, IVÐB, and VIIÐB 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 para- graph (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 C15ÐC21 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(C12ÐC20)methacrylatemethacrylic acid copolymers (CAS For use only as stabilizers employed prior to the sheetÐforming Reg. No. 27401Ð06Ð5). operation in the manufacture of paper and paperboard.
tert-Alkyl(C8ÐC16)mercaptans ...... For use only as polymerization-control agent. Aluminum acetate. 2-Amino-2-methyl-1-propanol (CAS Reg. No. 124Ð68Ð5) ...... For use as a dispersant for pigment suspension at a level not to exceed 0.25 percent by weight of pigment. The suspen- sion is used as a component of coatings for paper and pa- perboard under conditions of use described in paragraph (c) of this section, table 2, conditions of use E through G.
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List of Substances Limitations
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 flu- orine 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 de- scribed in table 2 of paragraph (c) of this section, with non- alcoholic food. 2. In contact with bakery products of Type VII, VIII, and IX de- scribed in table I of paragraph (c) of this section under good manufacturing practices of commercial and institutional bak- ing. Ammonium persulfate. Ammonium thiosulfate. Ammonium zirconium carbonate (CAS Reg. No. 32535Ð84Ð5) 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. Ammonium zirconium citrate (CAS Reg. No. 149564Ð62Ð5), For use as insolubilizers with protein binders in coatings for ammonium zirconium lactate-citrate (CAS Reg. No. 149564Ð paper and paperboard, at a level not to exceed 1.4 percent 64Ð7), ammonium zirconium lactate (CAS Reg. No. 149564Ð by weight of coating solids. 63Ð6). 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 per- cent N-methyldiethanolamine and not less than 90 mole per- cent dimethylolpropionic acid. The final product is a 15 to 20 percent by weight aqueous solution, having a Brookfield vis- cosity of 25 to 100 centipoises at 24 °C (75 °F). 9,10ÐAnthraquinone (Chemical Abstracts Service Registry No. For use only as a pulping aid in the alkaline pulping of 84Ð65Ð1) 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. 88526Ð47Ð0), 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 28Ð67 (Reapproved 1982), ‘‘Standard Test Meth- od for Softening Point by Ring-and-Ball Apparatus,’’ and ani- line point 70 °C (158 °F) minimum, as determined by ASTM Method D 611Ð82, ‘‘Standard Test Methods for Aniline Point and Mixed Aniline Point of Petroleum Products and Hydro- carbon Solvents,’’ which are incorporated by reference in ac- cordance 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. 2634Ð33Ð5) ...... 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 (C12ÐC18)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.
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List of Substances Limitations
Bis(methoxymethyl)tetrakis-[(octadecyloxy)-methyl]melamine For use only under the following conditions: resins having a 5.8Ð6.5 percent nitrogen content (CAS Reg. 1. As a water repellant employed prior to the sheet-forming op- No. 68412Ð27Ð1). 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 oper- ation 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, IVÐB, VI, VIIÐB, and VIII described in table 1 of paragraph (c) of this section. 2-Bromo-2-nitro-1,3-propanediol (CAS Reg. No. 52Ð51Ð7) ...... 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. 144093Ð88Ð9]).. 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. 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 pa- perboard 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(C16ÐC18)carbamoyl chloride (CAS Reg. No. 41319Ð54Ð 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 per- cent by weight aqueous solution (active polymer) has a vis- cosity of more than 22 centipoises at 22 °C (72 °F) as deter- mined by LVF series, Brookfield Viscometer using No. 1 spindle at 60 RPM (or by other equivalent method) (CAS Reg. No. 25136Ð75Ð8). Diallyldimethylammonium chloride with acrylamide (CAS Reg. For use only as a drainage and/or retention aid employed prior No. 26590Ð05Ð6). 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 50Ð50 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 de- termined by LVF-series Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or by other equivalent method).
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List of Substances Limitations
Diallyldiethylammonium chloride polymer with acrylamide, and diallyldimethylammonium chloride, produced by copolym- erizing acrylamide, diallyldiethylammonium chloride, and diallyldimethylammonium chloride, respectively, in the fol- lowing weight ratios and having viscosities determined at 22 °C, by LVF-series Brookfield viscometer using a No. 1 spin- dle at 60 r.p.m. (or by other equivalent method), as follows:. 1. Weight ratio: 50Ð2.5Ð47.5. 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 per- cent by weight of the finished paper and paperboard. 2. Weight ratio: 25Ð2.5Ð72.5. 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 paper- board. 3. Weight ratio: 80Ð2.5Ð17.5. 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 paper- board. 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 50Ð 2.5Ð47.5, respectively, with 4.4 percent of the acrylamide subsequently hydrolyzed to potassium acrylate, or (2) acryl- amide, potassium acrylate (as acrylic acid), diallyldiethylammonium chloride, and diallyldimethylammonium chloride in a weight ratio of 47.8Ð 2.2Ð2.5Ð47.5, so that the finished resin in a 1 percent by weight aqueous solution has a minimum viscosity of 22 cen- tipoises 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 deter- mined by Brookfield viscometer Model RVF, using a No. 1 spindle at 100 r.p.m. 2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No.10222Ð01Ð2). 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 paper- board and coatings for paper and paperboard. 2,5-Di-tert-butyl hydroquinone ...... For use only as an antioxidant for fatty based coating adju- vants 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 C 8¥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 with- out correction for any fluorine which might be present in the untreated paper or paperboard, when such paper or paper- board 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).
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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. [26796Ð75Ð8] having 90Ð95 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-se- ries 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. Diphenylamine ...... For use only as an antioxidant for fatty based coating adju- vants 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. 73347Ð80Ð5). 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 paper- board 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 paper- board 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. 111Ð30Ð8) ...... 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.
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Glyceryl lactostearate. Glyceryl mono-1,2-hydroxystearate. Glyceryl monoricinoleate. Guar gum modified by treatment with β-diethylamino- ethyl 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, IVÐB, VIÐB, VIIÐB, and VIII of table I in par. (c) of this section. N, N, N′,N′,N′′,N′′-Hexakis (methoxymethyl)-1,3,5-triazine- For use only as a water-repellent applied to the surface of 2,4,6-triamine polymer with stearyl alcohol, α-octadecenyl- paper and paperboard at levels not to exceed 1 percent by omega-hydroxypoly(oxy-1,2-ethanediyl), and alkyl (C20∂) al- weight of the finished dry paperboard fibers. The finished cohols (CAS Reg. No. 130328Ð24Ð4). 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. Hydroxymethyl-5,5-dimethylhydantoin (CAS Reg. No. 27636Ð For use only as a preservative in clay-type fillers at a level not 82Ð4), mixture with 1,3-bis(hydroxymethyl)-5,5- to exceed a combined total of 1,200 milligrams/kilograms dimethylhydantoin (CAS Reg. No. 6440Ð58Ð0). 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. 70142Ð34Ð6) 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, 2Ð(C17 and C17-unsaturated alkyl)-1Ð For use only at a level not to exceed 0.5 percent by weight of [2Ð(C18 and C18-unsaturated amido)ethyl]-4,5-dihydro-1- the dry paper and paperboard. methyl, methyl sulfates (CAS Reg. No. 72749Ð55Ð4).. Isopropyl m- and p-cresols (thymol derived) ...... For use only as an antioxidant for fatty based coating adju- vants 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. 113221Ð69Ð5) 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. 25751Ð For use only as a boiler water additive at a level not to exceed 21Ð7). 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).
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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 61791Ð41Ð1). 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. 68130Ð71Ð2). paper and paperboard. Monoglyceride citrate. Monoisopropanolamine (CAS Reg. No. 78Ð96Ð6) ...... For use as a dispersant for titanium dioxide suspensions at a level not to exceed 0.68 percent by weight of titanium diox- ide. The finished paper and paperboard will be used in con- tact 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, 10.9Ð12.2% nitrogen. Oleic acid, sulfated, ammonium, potassium, or sodium salt. N-Oleoyl-N′-stearoylethylenediamine. Oxystearin. Paraformaldehyde ...... For use only as setting agent for protein.
Pentanoic acid, 4,4Ðbis [(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. 71608Ð61Ð2). 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. 92265Ð81Ð1) 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[ (γ,ω-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, IVÐA, V, VIIÐA, and IX described in table 1 of para- graph (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 D36Ð76, ‘‘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 D5Ð73 (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 ad- ditional 1.1% when further distilled between 371° C and ther- mal 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-formalde- hyde modified alkyd coatings and limited to use at a level not to exceed 2% by weight of the coating solids. Phenyl-β-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.
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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 pa- perboard 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/in 2 of the fin- ished paper and paperboard. Poly[acrylamide-acrylic acid-N-(dimethylaminomethyl) acryl- For use only as a drainage aid, retention aid, or dry-strength amide] (C.A. Registry No. 53800Ð41Ð2), produced by react- agent employed prior to the sheet-forming operation in the ing 9.6Ð16.4 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 13Ð16 percent (Kjeldahl, dry basis) such that a 35 percent by weight aque- ous 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. 68583Ð79Ð9] 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 IVÐB 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. 96387Ð48Ð3) 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 per- acid 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. 167678Ð45Ð7).
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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 10.9Ð11.9 percent and a chlorine content of 13.8Ð 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 viscom- eter using a No. 1 spindle at 60 r.p.m. (or equivalent meth- od). 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). 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 [27029Ð41Ð0], 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 4Ð6) 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 con- tent 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 viscom- eter using a No. 1H spindle at 50 r.p.m. (or equivlent meth- od). 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 pro- duced 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 vis- cometer 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 5.0Ð5.3 percent; a chlorine content of 29.7Ð31.3 percent; and a phosphorus content of 2.0Ð2.2 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 spin- dle at 50 r.p.m. (or equivalent method).
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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 13.0Ð 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 10.9Ð12.4 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. Poly(diallyldimethylammonium chloride) (CAS Reg. No. 26062Ð For use only: 79Ð3) 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- 26062Ð79Ð3) 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 so- lution 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. 4767Ð03Ð7) 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 200Ð600 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 VIIÐB of table 1 in para- graph (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 spin- dle 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.
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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 paper- board. 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 125Ð325 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 400Ð700 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. 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 D1545Ð76 (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. D1243Ð79, ‘‘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 deter- mining 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. 110224Ð99Ð2). 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 con- densed 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-C9Ð49-alkyl (CAS Reg. No. 144635Ð08Ð5). ¤ 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 VIÐA and VIÐB 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.
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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. Sodium nitrite ...... For use only: 1. At levels not to exceed 0.2% by weight of lubricants or re- lease 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 manu- facture 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, pro- vided 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. 118632Ð For use only in paper mill boilers. 18Ð1). Sodium zinc potassium polyphosphate (CAS Reg. No. 65997Ð For use only as a pigment dispersant in coatings at a level not 17Ð3). 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 sty- rene-butadiene with one or more of the monomers: acryl- amide, acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid, methacrylic acid, and N-methylolacrylamide (CAS Reg. No. 53504Ð31Ð7). 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 con- tain 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, IVÐB, VI, VIIÐB 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.
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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 56136Ð14Ð2). 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 4.7Ð4.9 percent and viscosity of 350Ð700 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). Tetrasodium N- (1,2-dicarboxyethyl) - N - octadecylsulfoÐsuc- 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 ex- ceed 0.02 pct by weight of finished paper and paperboard. Triethanolamine ...... For use only to adjust pH during the manufacture of amino res- ins permitted for use as components of paper and paper- board. 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. 7779Ð For use only as an antimicrobial agent for coating, binder, pig- 27Ð3). ment, filler, sizing, and similar formulations added prior to the heat drying step in the manufacture of paper and paper- board 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 ft 2 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. 68989Ð22Ð0) ...... For use as a pigment extender at levels not to exceed 5.4 per- cent 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.
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Acrylamide copolymerized with ethyl acrylate and/or stryene and/or methacrylic acid, subsequently reacted with formalde- hyde 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. 35641Ð59Ð9). Acrylic and modified acrylic polymers ...... Complying with ¤ 177.1010 of this chapter. 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 fin- ished 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 acry- late, 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 meth- acrylate, 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 co- polymers 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 C10ÐC18 with not less than 50 per- 1. As emulsifiers for vinylidene chloride copolymer coatings cent C14ÐC16).. 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 poly- mer 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, bind- ers, pigment slurries, and sizing solutions at a level not to exceed 0.006 percent by weight of the coating, solution, slur- ry 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 identi- fied in paragraph (c) of this section, table 1, under Type I, II, VIÐB, 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. 4080Ð31Ð3). 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 para- graph (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 pa- perboard intended for use in contact with food.
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5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172Ð For use only: 55Ð4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 1. As an antimicrobial agent for polymer latex emulsions in 2682Ð20Ð4) 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 2935Ð90Ð2). The mixture may contain magnesium nitrate coating formulation. (CAS Reg. No. 10377Ð60Ð3) 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 mil- lion (based on isothiazolone active ingredients) in the coating formulations and additives. Copper 8-quinolinolate ...... For use only as preservative for coating formulations. 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 E28Ð67 (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 con- tains no more than 4000 ppm of residual-free phenol as de- termined 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 (HFSÐ 200), Food and Drug Administration, 200 C St. SW., Wash- ington, DC 20204, 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. 35691Ð65Ð7) .. 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. 120Ð55Ð8) ...... 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 an- hydride. Dihydroxy dichlorodiphenyl methane ...... For use only as preservative for coating formulations. Dimethylpolysiloxane, 100 centistokes viscosity. Dimethylpolysiloxane-beta-phenylethyl methyl polysiloxane co- polymer (2:1), 200 to 400 centistokes viscosity. N,N′-Diphenyl-p-phenylenediamine ...... For use only as polymerization inhibitor in 2-sulfoethyl meth- acrylate, sodium salt. Dipropylene glycol dibenzoate (CAS Reg. No. 27138Ð31Ð4) ..... 1. For use only as a plasticizer for polyvinyl acetate coatings at a level not to exceed 5 percent by weight of the coating sol- ids under conditions described in paragraph (c) of this sec- tion, 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 coat- ing 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.
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Ethylene-acrylic acid copolymers produced by the copolym- erization of ethylene and acrylic acid and/or their partial am- monium 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 D1238Ð82, ‘‘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. 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. α-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1α- methylstyrene to 3 vinyltoluene). Modified kaolin clay (CAS Reg. No. 1344Ð00Ð9) is produced For use only as a component of coatings in paper and paper- by the reaction of sodium silicate (CAS Reg. No. 1344Ð09Ð board products at a level not to exceed 9 percent by weight 8) and kaolinite clay (CAS Reg. No. 1332Ð58Ð7) 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 re- action product will not consist of more than 70 percent modi- fied kaolin clay. Naphthalene sulfonic acid-formaldehyde condensate, sodium salt. Oleyl alcohol. Oxazolidinylethylmethacrylate (CAS Registry No. 46236Ð15Ð1) 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.
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List of substances Limitations
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 E28Ð67 (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 D611Ð82, ‘‘Standard Test Methods for Aniline Point and Mixed Aniline Point of Petroleum Products and Hydrocarbon Solvents,’’ which are incorporated by reference (copies may be ob- tained 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 0.96Ð0.99 (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 gly- col, such that the polyester resin has an acid number of 4 to 11, a drop-softening point of 70 °CÐ92 °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 modi- fied 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 paper- board. 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. 68083Ð19Ð2 and 68083Ð18Ð1) with methyl hydrogen 1. In coatings for paper and paperboard provided the coating polysiloxane (CAS Reg. No. 63148Ð57Ð2) or dimethyl (meth- contacts food only of the types identified in paragraph (c) of yl hydrogen) polysiloxane (CAS Reg. No. 68037Ð59Ð2). this section, table 1, under Types I, II, VI, and VIIÐB when Diallyl maleate (CAS Reg No. 999Ð21Ð3), dimethyl maleate used under conditions of use E, F, and G described in table (CAS Reg. No. 624Ð48Ð6), 1-ethynyl-1-cyclohexanol (CAS 2 of paragraph (c) of this section. Reg. No. 78Ð27Ð3) and vinyl acetate (CAS Reg. No. 108Ð 2. In coatings for paper and paperboard provided the coating 05Ð4) 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, VIIÐA, VIII, and IX when used under conditions of use A through H de- scribed 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. 68083Ð19Ð2 and 68083Ð18Ð1), with methyl hydrogen polysiloxane (CAS Reg. No. 63148Ð57Ð2). Dimethyl maleate (CAS Reg. No. 624Ð48Ð6), vinyl acetate (CAS Reg. No. 108Ð05Ð4), dibutyl maleate (CAS Reg. No. 105Ð76Ð0) and diallyl maleate (CAS Reg. No. 999Ð21Ð3) may be used as optional polymerization inhibitors. The polymer may also contain C16ÐC18 olefins (CAS Reg. No. 68855Ð60Ð7) as a control release agent. Sodium decylbenzenesulfonate. Sodium dihexyl sulfosuccinate.
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List of substances Limitations
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 IVÐA, 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. 1300Ð72Ð7) ...... For use only in paper and paperboard coatings at levels not to exceed 0.01 percent by weight of the finished paper and pa- perboard. 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 β-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 IVÐA, 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 aver- age molecular weight (Mn) shall be at least 2,000 (as deter- mined 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. 25950Ð40Ð7 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 copoly- mers have a minimum number average molecular weight greater than 100,000 and a level of residual styrene mon- omer in the polymer not to exceed 0.1 percent by weight. Styrene-butadiene copolymers produced by copolymerizing sty- rene-butadiene with one or more of the monomer: acryl- amide, 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 poly- mer units derived from acrylic acid, fumaric acid, 2-hydroxy- ethyl acrylate, itaconic acid and methacrylic acid, and shall contain not more than 2 weight percent of polymer units de- rived 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 com- bination 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 de- rived from acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid, and/or methacrylic acid. Styrene-dimethylstyrene-α-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 D2503Ð82, ‘‘Standard Test Method for Molecular Weight (Relative Molecular Mass) of Hydrocarbons by Thermo- electric Measurement of Vapor Pressure,’’ which is incor- porated 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, IVÐB, VIÐB, VIIÐB, and VIII described in table 1 of para- graph (c) of this section; and limited to use at a level not to exceed 40 percent by weight of the coating solids.
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List of substances Limitations
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. 1804Ð87Ð1]. 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. α[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 α-[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, VIÐB, and VII, and under the con- ditions 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, condi- tions 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. Vinyl acetate copolymers produced by copolymerizing vinyl ac- etate 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 propio- nate, vinyl pyrrolidone, vinyl stearate, and vinyl sulfonic acid. The finished copolymers shall contain at least 50 weight per- cent 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 ac- rylate, 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 con- ditions 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, condi- tions of use C, D, E, F, and G.
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List of substances Limitations
Vinyl chloride copolymers produced by copolymerizing vinyl chloride with one or more of the monomers acrylonitrile; fu- maric 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 an- hydride; 5-norbornene-2, 3-dicarboxylic acid, mono-n-butyl ester; vinyl acetate-and vinylidene chloride. The finished co- polymers 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 re- acted with trimellitic anhydride. Vinylidene chloride copolymers produced by copolymerizing vi- nylidene chloride with one or more of the monomers acryl- amide acrylic acid, acrylonitrile, butyl acrylate, butyl meth- acrylate ethyl acrylate, ethyl methacrylate, fumaric acid, itaconic acid, methacrylic acid, methyl acrylate, methyl meth- acrylate, octadecyl methacrylate, propyl acrylate, propyl methacrylate, vinyl chloride and vinyl sulfonic acid. The fin- ished 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 sul- fonic 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. 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. 147Ð14Ð 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 and under conditions of time and tem- paper and paperboard in the finished perature characterizing the conditions form in which it is to contact food, of its intended use as determined from when extracted with the solvent or sol- tables 1 and 2 of this paragraph, shall vents characterizing the type of food,
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yield net chloroform-soluble extrac- TABLE 1—TYPES OF RAW AND PROCESSED tives (corrected for wax, petrolatum, FOODS—Continued mineral oil and zinc extractives as zinc IV. Dairy products and modifications: oleate) not to exceed 0.5 milligram per A. Water-in-oil emulsions, high- or low-fat. square inch of food-contact surface as B. Oil-in-water emulsions, high- or low-fat. determined by the methods described V. Low-moisture fats and oil. VI. Beverages: in paragraph (d) of this section. A. Containing up to 8 percent of alcohol. B. Nonalcoholic. TABLE 1—TYPES OF RAW AND PROCESSED C. Containing more than 8 percent alcohol. FOODS VII. Bakery products other than those included under Types I. Nonacid, aqueous products; may contain salt or sugar or VIII or IX of this table: both (pH above 5.0). A. Moist bakery products with surface containing free fat II. Acid, aqueous products; may contain salt or sugar or or oil. both, and including oil-in-water emulsions of low- or high- B. Moist bakery products with surface containing no free fat content. fat or oil. III. Aqueous, acid or nonacid products containing free oil or VIII. Dry solids with the surface containing no free fat or oil fat; may contain salt, and including water-in-oil emulsions (no end test required). of low- or high-fat content. 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, IVÐB, VIIÐB ..... 250 °F, 2 hr ...... over 212 °F). III, IVÐA, VIIÐA ...... do ...... 150 °F, 2 hr ...... B. Boiling water sterilized ...... II, VIIÐB ...... 212 °F, 30 ...... min. III, VIIÐA ...... do ...... 120 °F, 30 ...... min. C. Hot filled or pasteurized above 150 °F .... II, IVÐB, VIIÐB .... Fill boiling, ...... cool to 100 °F. III, IVÐA, VIIÐA ...... do ...... 120 °F, 15 ...... min. V, IX ...... do ...... D. Hot filled or pasteurized below 150 °F ..... II, IVÐB, VIÐB, ...... VIIÐB ...... 150 °F, 2 hr ...... III, IVÐA, VIIÐA ...... do ...... 100 °F, 30 ...... min. V, IX ...... do ...... VIÐA ...... 150 °F, 2 hr ...... VIÐC ...... 150 °F, 2 hr. E. Room temperature filled and stored (no I, II, IVÐB, VIÐB, 120 °F, 24 hr ...... thermal treatment in the container). VIIÐB. III, IVÐA, VIIÐA ...... do ...... 70 °F, 30 ...... min. V, IX ...... do ...... VIÐA ...... 120 °F, 24 hr ...... VIÐC ...... 120 °F, 24 hr. F. Refrigerated storage (no thermal treat- III, IVÐA, VIIÐA ... 70 °F, 48 hr 70 °F, 30 ...... ment in the container). min. I, II, IVÐB, VIÐB, ...... do ...... VIIÐB. VIÐA ...... 70 °F, 48 hr ...... VIÐC ...... 70 °F, 48 hr. G. Frozen storage (no thermal treatment in I, II, IVÐB, VIIÐB 70 °F, 24 hr ...... the container). III, VIIÐA ...... 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, IVÐB, VIIÐB 212 °F, 30 ...... high- or low-fat. min.
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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
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
2. Aqueous, high- or low-free oil or fat .. III, IVÐA, VIIÐA, ...... 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 Chemists International, 481 North extractability conditions. First ascertain Frederick Ave., suite 500, Gaithersburg, the type of food product (table 1, para- MD 20877–2504, or may be examined at graph (c) of this section) that is being the Office of the Federal Register, 800 packed commercially in the paper or North Capitol Street, NW., suite 700, paperboard and the normal conditions Washington, DC 20408); also described of thermal treatment used in pack- in ASTM method F34–76 (Reapproved aging the type of food involved. Using 1980), ‘‘Standard Test Method for Liq- table 2, paragraph (c) of this section, uid Extraction of Flexible Barrier Ma- select the food-simulating solvent or terials,’’ which is incorporated by ref- solvents and the time-temperature ex- erence (copies may be obtained from aggerations of the paper or paperboard the American Society for Testing Ma- use conditions. Having selected the ap- terials, 1916 Race St., Philadelphia, PA propriate food-simulating solvent or 19103, or may be examined at the Office solvents and the time-temperature ex- of the Federal Register, 800 North Cap- aggeration over normal use, follow the itol Street, NW., suite 700, Washington, applicable extraction procedure. DC 20408), except that formed paper and (2) Reagents—(i) Water. All water used paperboard products may be tested in in extraction procedures should be the container by adapting the in-con- freshly demineralized (deionized) dis- tainer methods described in § 175.300(e) tilled water. of this chapter. Formed paper and pa- (ii) n-Heptane. Reagent grade, freshly perboard products such as containers redistilled before use, using only mate- and lids, that cannot be tested satisfac- rial boiling at 208 °F. torily by any of the above methods (iii) Alcohol. 8 or 50 percent (by vol- may be tested in specially designed ex- ume), prepared from undenatured 95 traction equipment, usually consisting percent ethyl alcohol diluted with of clamping devices that fit the closure demineralized (deionized) distilled or container so that the food-contact water. surface can be tested, or, if flat sam- (iv) Chloroform. Reagent grade, fresh- ples can be cut from the formed paper ly redistilled before use, or a grade or paperboard products without de- having an established consistently low stroying the integrity of the food-con- blank. tact surface, they may be tested by (3) Selection of test method. Paper or adapting the following ‘‘sandwich’’ paperboard ready for use in packaging method: shall be tested by use of the extraction (i) Apparatus. (a) Thermostated (±1.0 cell described in ‘‘Official Methods of °F) water bath, variable between 70 °F Analysis of the Association of Official and 120 °F water bath cover capable of Analytical Chemists,’’ 13th Ed. (1980), holding at least one 800-milliliter beak- sections 21.010–21.015, under ‘‘Exposing er partially submersed in bath. Flexible Barrier Materials for Extrac- (b) Analytical balance sensitive to 0.1 tion,’’ which is incorporated by ref- milligram with an approximate capac- erence (copies may be obtained from ity of 100 grams. the Association of Official Analytical (c) Tongs.
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(d) Hood and hot-plate facilities. container or test cell from the oven (e) Forced draft 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, and transfer to a clean, tared (i) Five 21⁄2-inch-square aluminum screens (standard aluminum window evaporating dish (platinum or Pyrex), screening is acceptable). washing the flask three times with (j) One wire capable of supporting small portions of solvent used in the sample stack. extraction procedure, and evaporate to (ii) Procedure. (a) For each extrac- a few milliliters on a nonsparking, low- temperature hotplate. The last few tion, accurately cut eight 21⁄2-inch- square samples from the formed paper milliliters should be evaporated in an or paperboard product to be tested. oven maintained at a temperature of approximately 221 °F. Cool the (b) Carefully stack the eight 21⁄2-inch- evaporating dish in a desiccator for 30 square samples and the five 21⁄2-inch- square aluminum screens in sandwich minutes and weigh the residue to the form such that the food-contact side of nearest 0.1 milligram, (e). Calculate the each sample is always next to an alu- extractives in milligrams per square minum screen, as follows: Screen, sam- inch of the container or sheeted paper ple, sample, screen, sample, sample, or paperboard surface. screen, etc. Clip the sandwich together (a) Water and 8- and 50-percent alcohol. Milligrams extractives per square carefully with a No. 2 paper clip, leav- inch=(e)/(s). ing just enough space at the top to slip (b) Heptane. Milligrams extractives a wire through. per square inch=(e)/(s)(F) (c) Place an 800-milliliter beaker con- taining 100-milliliters of the appro- where: priate food-simulating solvent into the e=Milligrams extractives per sample tested. constant temperature bath, cover with s=Surface area tested, in square inches. a watch glass and condition at the de- F=Five, the ratio of the amount of extrac- tives removed by heptane under exagger- sired temperature. ated time-temperature test conditions (d) After conditioning, carefully compared to the amount extracted by a lower the sample sandwich with tongs fat or oil under exaggerated conditions of into the beaker. thermal sterilization and use. (e) At the end of the extraction pe- e′=Chloroform-soluble extractives residue. riod, using the tongs, carefully lift out ee′=Corrected chloroform-soluble extractives the sample sandwich and hang it over residue. e′ or ee′ is substituted for e in the above equa- the beaker with the wire. tions when necessary. (f) After draining, pour the food-sim- ulating solvent solution into a tared If when calculated by the equations in 250-milliliter beaker. Rinse the 800-mil- paragraph (d)(5)(i) (a) and (b) of this liliter beaker three times, using a total section, the extractives in milligrams of not more than 50 milliliters of the per square inch exceeds the limitations required solvent. prescribed in paragraph (c) of this sec- (g) Determine total nonvolatile ex- tion, proceed to paragraph (d)(5)(ii) of tractives in accordance with paragraph this section (method for determining (d)(5) of this section. the amount of chloroform-soluble ex- (4) Selection of samples. Quadruplicate tractives residues). samples should be tested, using for (ii) Chloroform-soluble extractives res- each replicate sample the number of idue. Add 50 milliliters of chloroform cups, containers, or preformed or con- (freshly distilled reagent grade or a verted products nearest to an area of grade having an established consist- 100 square inches. ently low blank) to the dried and (5) Determination of amount of extrac- weighed residue, (e), in the evaporating tives—(i) Total residues. At the end of dish obtained in paragraph (d)(5)(i) of the exposure period, remove the test this section. Warm carefully, and filter
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through Whatman No. 41 filter paper the column (or buret) may be option- (or equivalent) in a Pyrex (or equiva- ally fitted with a 100-millimeter sol- lent) funnel, collecting the filtrate in a vent reservoir. clean, tared evaporating dish (platinum (2) Preparation of column. Place a or Pyrex). Repeat the chloroform ex- snug pledget of fine glass wool in the traction, washing the filter paper with bottom of the column (or buret) if the this second portion of chloroform. Add column (or buret) is not equipped with this filtrate to the original filtrate and integral coarse, fritted glass disc. Over- evaporate the total down to a few mil- lay the glass wool pledget (or fritted liliters on a low-temperature hotplate. glass disc) with a 15–20 millimeter deep The last few milliliters should be evap- layer of fine sand. Measure in a grad- orated in an oven maintained at ap- uated cylinder 15 milliliters of proximately 221 °F. Cool the chromatographic grade aluminum evaporating dish in a desiccator for 30 oxide (80–200 mesh) that has been tight- minutes and weigh to the nearest 0.1 ly settled by tapping the cylinder. milligram to get the chloroform-solu- Transfer the aluminum oxide to the ble extractives residue (′). This ′ is sub- chromatographic tube, tapping the stituted for e in the equations in para- tube during and after the transfer so as graph (d)(5)(i) (a) and (b) of this sec- to tightly settle the aluminum oxide. tion. If the chloroform-soluble extrac- Overlay the layer of aluminum oxide tives in milligrams per square inch with a 1.0–1.5 centimeter deep layer of still exceeds the limitation prescribed anhydrous sodium sulfate and on top of in paragraph (c) of this section, proceed this place an 8–10 millimeter thick plug to paragraph (d)(5)(iii) of this section of fine glass wool. Next carefully add (method for determining corrected about 25 milliliters of heptane to the chloroform-soluble extractives res- column with stopcock open, and allow idue). the heptane to pass through the col- (iii) Corrected chloroform-soluble ex- umn until the top level of the liquid tractives residue—(a) Correction for zinc just passes into the top glass wool plug extractives. Ash the residue in the in the column, and close stopcock. evaporating dish by heating gently (3) Chromatographing of sample ex- over a Meker-type burner to destroy tract—(i) For chloroform residues weigh- organic matter and hold at red heat for ing 0.5 gram or less. To the dried and about 1 minute. Cool in the air for 3 weighed chloroform-soluble extract minutes, and place the evaporating residue in the evaporating dish, ob- dish in the desiccator for 30 minutes tained in paragraph (d)(5)(ii) of this and weigh to the nearest 0.1 milligram. section, add 20 milliliters of heptane Analyze this ash for zinc by standard and stir. If necessary, heat carefully to Association of Official Agricultural dissolve the residue. Additional Chemists methods or equivalent. Cal- heptane not to exceed a total volume of culate the zinc in the ash as zinc ole- 50 milliliters may be used if necessary ate, and subtract from the weight of to complete dissolving. Cool to room chloroform-soluble extractives residue temperature. (If solution becomes (′) to obtain the zinc-corrected chloro- cloudy, use the procedure in paragraph form-soluble extractives residue (e′). (d)(5)(iii)(b)(3)(ii) of this section to ob- This e′ is substituted for e in the equa- tain an aliquot of heptane solution cal- tions in paragraph (d)(5)(i) (a) and (b) of culated to contain 0.1–0.5 gram of chlo- this section. roform-soluble extract residue.) Trans- (b) Correction for wax, petrolatum, and fer the clear liquid solution to the col- mineral oil—(1) Apparatus. Standard 10 umn (or buret). Rinse the dish with 10 millimeter inside diameter × 60 centi- millimeters of additional heptane and meter chromatographic column (or add to column. Allow the liquid to pass standard 50-milliliter buret with an in- through the column into a clean, tared side diameter of 10–11 millimeters) evaporating dish (platinum or Pyrex) with a stopcock of glass, at a dropwise rate of about 2 milliliters perfluorocarbon resin, or equivalent per minute until the liquid surface material. The column (or buret) may reaches the top glass wool plug; then be optionally equipped with an integral close the stopcock temporarily. Rinse coarse, fritted glass disc and the top of the Pyrex flask which contained the
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filtrate with an additional 10–15 milli- soluble extracts which contain high liters of heptane and add to the col- melting waxes (melting point greater umn. Wash (elute) the column with than 170 °F), it may be necessary to di- more heptane collecting about 100 mil- lute the heptane solution further so liliters of total eluate including that that a 50-milliliter aliquot will contain already collected in the evaporating only 0.1–0.2 gram of the chloroform- dish. Evaporate the combined eluate in soluble extract residue.) the evaporating dish to dryness on a (e) Acrylonitrile copolymers identi- steam bath. Dry the residue for 15 min- fied in this section shall comply with utes in an oven maintained at a tem- the provisions of § 180.22 of this chap- perature of approximately 221 °F. Cool ter, except where the copolymers are the evaporating dish in a desiccator for restricted to use in contact with food 30 minutes and weigh the residue to the only of the type identified in paragraph nearest 0.1 milligram. Subtract the (c), table 1 under Category VIII. weight of the residue from the weight [42 FR 14554, Mar. 15, 1977] of chloroform-soluble extractives res- idue (′) to obtain the wax-, petrolatum- EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 176.170, see the List of CFR , and mineral oil-corrected chloroform- Sections Affected, which appears in the soluble extractives residue (e′). This e′ Finding Aids section of the printed volume is substituted for e in the equations in and on GPO Access. paragraph (d)(5)(i) (a) and (b) of this section. § 176.180 Components of paper and pa- (ii) For chloroform residues weighing perboard in contact with dry food. more than 0.5 gram. Redissolve the The substances listed in this section dried and weighed chloroform-soluble may be safely used as components of extract residue as described in para- the uncoated or coated food-contact graph (d)(5)(iii)(b)(3)(i) of this section surface of paper and paperboard in- using proportionately larger quantities tended for use in producing, manufac- of heptane. Transfer the heptane solu- turing, packing, processing, preparing, tion to an appropriate-sized volumetric treating, packaging, transporting, or flask (i.e., a 250-milliliter flask for holding dry food of the type identified about 2.5 grams of residue) and adjust in § 176.170(c), table 1, under Type VIII, to volume with additional heptane. Pi- subject to the provisions of this sec- pette out an aliquot (about 50 milli- tion. liters) calculated to contain 0.1–0.5 (a) The substances are used in gram of the chloroform-soluble extract amounts not to exceed that required to residue and analyze accomplish their intended physical or chromatographically as described in technical effect, and are so used as to paragraph (d)(5)(iii)(b)(3)(i) of this sec- accomplish no effect in food other than tion. In this case the weight of the that ordinarily accomplished by pack- dried residue from the heptane eluate aging. must be multiplied by the dilution fac- (b) The substances permitted to be tor to obtain the weight of wax, petro- used include the following: latum, and mineral oil residue to be (1) Substances that by § 176.170 and subtracted from the weight of chloro- other applicable regulations in parts form-soluble extractives residue (′) to 170 through 189 of this chapter may be obtain the wax-, petrolatum-, and min- safely used as components of the eral oil-corrected chloroform-soluble uncoated or coated food-contact sur- extractives residue (e′). This e′ is sub- face of paper and paperboard, subject stituted for e in the equations in para- to the provisions of such regulation. graph (d)(5)(i) (a) and (b) of this sec- (2) Substances identified in the fol- tion. (Note: In the case of chloroform- 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. 38193Ð60Ð1). 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. 70983Ð55Ð0)..
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List of substances Limitations
4-[2-[2-(2-Alkoxy(C12ÐC15) 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 C10ÐC18 with not less than 50 per- cent C14ÐC16).. 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. 2634Ð33Ð5) ...... 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. 3064Ð70Ð8 ...... For use only as a preservative in coatings. Borax ...... For use as preservative in coatings. Boric acid ...... Do. sec-Butyl alcohol.. 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. 144093Ð88Ð9]). 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. 120Ð55Ð8) ...... 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.. 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 ethylene- diamine such that the finished mixture has a melting point of 212°Ð228 °F, as determined by ASTM method D127Ð60, and an acid value of 10 maximum. ASTM Method D127Ð60 ‘‘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. 27138Ð31Ð4) ..... 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 (C12ÐC18) diethanolamide.. Fish oil fatty acids, hydrogenated, potassium salt.. Formaldehyde.. Glyceryl monocaprate.. Glyceryl tribenzoate (CAS Reg. No. 614Ð33Ð5) ...... For use only as a plasticizer in polymeric coatings. Glyoxal..
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List of substances Limitations
Glyoxal-urea-formaldehyde condensate (CAS Reg. No. 27013Ð For use as an insolubilizer for starch in coatings. 01Ð0) 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. 53037Ð34Ð6) ...... 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, 2Ð(C17 and C17-unsaturated alkyl)-1Ð For use only at levels not to exceed 0.5 percent by weight of [2Ð(C18 and C18-unsaturated amido)ethyl]-4,5-dihydro-1- the dry paper and paperboard. methyl, methyl sulfates (CAS Reg. No. 72749Ð55Ð4).. Isopropanolamine hydrochloride.. Isopropyl m- and p-cresol (thymol derived).. Itaconic acid.. Maleic anhydride-diisobutylene copolymer, ammonium or so- dium 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, so- dium salt.. Methylated poly(NÐ1,2-dihydroxyethylene-1,3-imidazolidinÐ2Ð For use only only as an in solubilizer for starch. one). 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 vis- cosity in 56 percent-by-weight aqueous solution of 200 centi- poises at 25 °C, as determined by LVT-series Brookfield vis- cometer 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 C15ÐC21 groups. Monoglyceride citrate.. Myristo chromic chloride complex.. Napthalene sulfonic acid-formaldehyde condensate, sodium salt.. Nickel.. β-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. 68412Ð pounds per ton of paper. 14Ð6), and the acetate salts thereof (CAS Reg. No. 68784Ð 21Ð4), which may be emulsified with ethoxylated tallow alkyl amines (CAS Reg. No. 61791Ð26Ð2). α-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.. α-(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-(C16ÐC18) 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.
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List of substances Limitations
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 po- lymerization and subsequent hydrogenation of styrene, vinyltoluene, and indene types from distillates of cracked pe- troleum 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 11Ð15 percent and chlorine level of 20Ð23 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. 114133Ð44Ð7) or a sulfate (CAS Reg. No. 167678Ð43Ð5), having a weight-average mo- lecular weight of 1,300,000 and a number-average molecular weight of 16,000.. Polyamide-ethyleneimine-epichlorohydrin resin (CAS Reg. No. 115340Ð77Ð7), 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-α-hydro-omega-hydroxypoly(oxy-1,2- ethanediyl).. Polybutene, hydrogenated; complying with the identity pre- scribed 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. 150413Ð26Ð6). 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.
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List of substances Limitations
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. 106569Ð82Ð8). perboard coatings. Polyoxyethylene (minimum 12 moles) ester of tall oil (30%Ð 40% rosin acids).. Polyoxypropylene-polyoxyethylene glycol (minimum molecular weight 1,900).. Polyvinyl alcohol.. Potassium titanate fibers produced by calcining titanium diox- ide, potassium chloride, and potassium carbonate, such that the finished crystalline fibers have a nominal diameter of 0.20Ð0.25 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.. 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. α-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-omega hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and their sodium, po- tassium, and ammonium salts having a poly(oxyethylene) content averaging 6Ð9 or 40 moles.. α-[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.
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List of substances Limitations
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 effect in the defoaming agents or any coatings. limitation further provided. (c) Any substance employed in the The defoaming agents described in production of defoaming agents and this section may be safely used as com- which is the subject of a regulation in ponents of articles intended for use in parts 174, 175, 176, 177, 178 and § 179.45 of producing, manufacturing, packing, this chapter conforms with any speci- processing, preparing, treating, pack- fication in such regulation. aging, transporting, or holding food, (d) Substances employed in the for- subject to the provisions of this sec- mulation of defoaming agents include: tion. (1) Substances generally recognized (a) The defoaming agents are pre- as safe in food. pared as mixtures of substances de- (2) Substances subject to prior sanc- scribed in paragraph (d) of this section. tion or approval for use in defoaming (b) The quantity of any substance agents and used in accordance with employed in the formulation of de- such sanction or approval. foaming agents does not exceed the (3) Substances identified in this para- amount reasonably required to accom- graph (d)(3) and subject to such limita- plish the intended physical or technical tions as are provided:
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. α-(Dinonylphenyl)-ω-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. 9014Ð93Ð1). 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..
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List of substances Limitations
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. β-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. 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.
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(e) The defoaming agents are used as Lard oil. follows: Linseed oil. (1) The quantity of defoaming agent Mustardseed oil. Palm oil. or agents used shall not exceed the Peanut oil. amount reasonably required to accom- Rapeseed oil. plish the intended effect, which is to Ricebran oil. prevent or control the formation of Soybean oil. foam. Sperm oil. (2) The defoaming agents are used in Tall oil. the preparation and application of (2) Fatty triglycerides, and marine coatings for paper and paperboard. oils, and the fatty acids and alcohols [42 FR 14554, Mar. 15, 1977, as amended at 62 derived therefrom (paragraph (d)(1) of FR 39772, July 24, 1997] this section) reacted with one or more of the following, with or without dehy- § 176.210 Defoaming agents used in the dration, to form chemicals of the cat- manufacture of paper and paper- egory indicated in parentheses: board. Aluminum hydroxide (soaps). Defoaming agents may be safely used Ammonia (amides). in the manufacture of paper and paper- Butanol (esters). board intended for use in packaging, Butoxy-polyoxypropylene, molecular weight transporting, or holding food in accord- 1,000–2,500 (esters). ance with the following prescribed con- Butylene glycol (esters). ditions: Calcium hydroxide (soaps). Diethanolamine (amides). (a) The defoaming agents are pre- Diethylene glycol (esters). pared from one or more of the sub- Ethylene glycol (esters). stances named in paragraph (d) of this Ethylene oxide (esters and ethers). section, subject to any prescribed limi- Glycerin (mono- and diglycerides). tations. Hydrogen (hydrogenated compounds). (b) The defoaming agents are used to Hydrogen (amines). prevent or control the formation of Isobutanol (esters). Isopropanol (esters). foam during the manufacture of paper Magnesium hydroxide (soaps). and paperboard prior to and during the Methanol (esters). sheet-forming process. Morpholine (soaps). (c) The quantity of defoaming agent Oxygen (air-blown oils). or agents added during the manufac- Pentaerythritol (esters). turing process shall not exceed the Polyoxyethylene, molecular weights 200, 300, amount necessary to accomplish the 400, 600, 700, 1,000, 1,540, 1,580, 1,760, 4,600 (esters). intended technical effect. Polyoxypropylene, molecular weight 200– (d) Substances permitted to be used 2,000 (esters). in the formulation of defoaming agents Potassium hydroxide (soaps). include substances subject to prior Propanol (esters). sanctions or approval for such use and Propylene glycol (esters). employed subject to the conditions of Propylene oxide (esters). such sanctions or approvals, substances Sodium hydroxide (soaps). generally recognized as safe for use in Sorbitol (esters). Sulfuric acid (sulfated and sulfonated com- food, substances generally recognized pounds). as safe for use in paper and paperboard, Triethanolamine (amides and soaps). and substances listed in this para- Triisopropanolamine (amides and soaps). graph, subject to the limitations, if Trimethylolethane (esters). any, prescribed. Zinc hydroxide (soaps). (1) Fatty triglycerides, and the fatty (3) Miscellaneous: acids, alcohols, and dimers derived therefrom: Alcohols and ketone alcohols mixture (still- bottom product from C12–C18 alcohol manu- Beef tallow. facturing process). Castor oil. Amyl alcohol. Coconut oil. Butoxy polyethylene polypropylene glycol Corn oil. molecular weight 900–4,200. Cottonseed oil. Butoxy-polyoxypropylene molecular weight Fish oil. 1,000–2,500.
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Butylated hydroxyanisole. Polyethylene, oxidized (air-blown). Butylated hydroxytoluene. Polymer derived from N-vinyl pyrrolidone Calcium lignin sulfonate. and copolymers derived from the mixed Capryl alcohol. alkyl (C12-C15, C16, C18, C20, and C22) meth- p-Chlorometacresol. acrylate esters, butyl methacrylate (CAS Cyclohexanol. Reg. No. 97–88–1), isobutyl methacrylate Diacetyltartaric acid ester of tallow mono- (CAS Reg. No. 97–86–9) and methyl meth- glyceride. acrylate (CAS Reg. No. 80–62–6); the com- 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. bined polymer contains no more than 5 35691–65–7), for use as a preservative at a weight percent of polymer units derived level not to exceed 0.05 weight-percent of from N-vinyl pyrrolidone and is present at the defoaming agent. a level not to exceed 7 parts per million by Diethanolamine. weight of the finished dry paper and paper- Diethylene triamine. board fibers. Di-(2-ethylhexyl) phthalate. Polyoxyethylene (4 mols) decyl phosphate. 2,6-Dimethyl heptanol-4 (nonyl alcohol). Polyoxyethylene (4 mols) di(2-ethyl hexano- Dimethylpolysiloxane. ate). Di-tert-butyl hydroquinone. Polyoxyethylene (15 mols) ester of rosin. Dodecylbenzene sulfonic acids. Polyoxyethylene (3–15 mols) tridecyl alcohol. Ethanol. Polyoxypropylene, molecular weight 200– 2-Ethylhexanol. 2,000. Ethylenediamine tetraacetic acid tetra- Polyoxypropylene-polyoxethylene conden- sodium salt. sate, minimum molecular weight 950. Formaldehyde. Polyoxypropylene-ethylene oxide condensate Heavy oxo-fraction (a still-bottom product of of ethylene diamine, molecular weight iso-octyl alcohol manufacture, of approxi- 1,700–3,800. mate composition: Octyl alcohol 5 percent Polyvinyl pyrrolidone, molecular weight nonyl alcohol 10 percent, decyl and higher 40,000. alcohols 35 percent, esters 45 percent, and Potassium distearyl phosphate. soaps 5 percent). Potassium pentachlorophenate. 2-Heptadecenyl-4-methyl-4-hydroxymethyl-2- Potassium trichlorophenate. oxazoline. Rosins and rosin derivatives identified in Hexylene glycol (2-methyl-2-4-pentanediol). § 175.105(c)(5) of this chapter. 12-Hydroxystearic acid. Silica. Isobutanol. Siloxanes and silicones, dimethyl, methylhy- Isopropanol. drogen, reaction products with poly- Isopropylamine salt of dodecylbenzene sul- ethylene-polypropylene glycol monoallyl fonic acid. ether (CAS Reg. No. 71965–38–3). Kerosine. Sodium alkyl (C9–C15) benzene-sulfonate. Lanolin. Sodium dioctyl sulfosuccinate. Methanol. Sodium distearyl phosphate. Methyl 12-hydroxystearate. Sodium lauryl sulfate. Methyl taurine-oleic acid condensate, molec- Sodium lignin sulfonate. ular weight 486. Sodium 2-mercaptobenzothiazole. a,a′-[Methylenebis[4-(1,1,3,3-tetramethylbu- Sodium naphthalenesulfonic acid (3 mols) tyl)-o-phenylene]]bis[omega-hydroxypoly condensed with formaldehyde (2 mols). (oxyethylene)] having 6–7.5 moles of ethyl- Sodium orthophenylphenate. ene oxide per hydroxyl group. Sodium pentachlorophenate. Mineral oil. Sodium petroleum sulfonate, molecular Mono-, di-, and triisopropanolamine. weight 440–450. Mono- and diisopropanolamine stearate. Sodium trichlorophenate. Monobutyl ether of ethylene glycol. Stearyl alcohol. Monoethanolamine. α-[p-(1,1,3,3-Tetramethylbutyl) phenyl-, p- Morpholine. nonylphenyl-, or p-dodecylphenyl]-omega- Myristyl alcohol. hydroxypoly(oxyethylene) produced by the Naphtha. condensation of 1 mole of p-alkylphenol β-Naphthol. (alkyl group is 1,1,3,3-tetramethylbutyl, a Nonylphenol. propylene trimer isomer, or a propylene Odorless light petroleum hydrocarbons. tetramer isomer) with an average of 1.5–15 Oleyl alcohol. moles of ethylene oxide. Petrolatum. Tetrahydrofurfuryl alcohol. o-Phenylphenol. Tributoxyethyl phosphate. Pine oil. Tributyl phosphate. 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.
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Tristearyl phosphate. § 176.260 Pulp from reclaimed fiber. Wax, petroleum, Type I and Type II. Wax, petroleum (oxidized). (a) Pulp from reclaimed fiber may be Wax (montan). safely used as a component of articles [42 FR 14554, Mar. 15, 1977, as amended at 47 used in producing, manufacturing, FR 17986, Apr. 27, 1982; 47 FR 46495, Oct. 19, packing, processing, preparing, treat- 1982; 47 FR 56845, Dec. 21, 1982; 54 FR 24897, ing, packaging, transporting, or hold- June 12, 1989; 57 FR 31313, July 15, 1992; 61 FR ing food, subject to the provisions of 14246, Apr. 1, 1996] paragraph (b) of this section. (b) Pulp from reclaimed fiber is pre- § 176.230 3,5-Dimethyl-1,3,5,2H- pared from the paper and paperboard tetrahydrothiadiazine-2-thione. products described in paragraphs (b) (1) 3,5-Dimethyl-1,3,5,2H-tetrahydrothi- and (2) of this section, by repulping adiazine-2-thione may safely be used as with water to recover the fiber with a preservative in the manufacture and the least possible amount of nonfibrous coating of paper and paperboard in- substances. tended for use in contact with food in (1) Industrial waste from the manu- accordance with the following pre- facture of paper and paperboard prod- scribed conditions: ucts excluding that which bears or con- (a) It is used as follows: tains any poisonous or deleterious sub- (1) In the manufacture of paper and stance which is retained in the recov- paperboard as a preservative for sub- ered pulp and that migrates to the stances added to the pulp suspension food, except as provided in regulations prior to the sheet-forming operation promulgated under sections 406 and 409 provided that the preservative is vola- of the Federal Food, Drug, and Cos- tilized by heat in the drying and fin- metic Act. ishing of the paper and paperboard. (2) Salvage from used paper and pa- (2) As a preservative for coatings for perboard excluding that which (i) bears paper and paperboard, Provided, That or contains any poisonous or delete- the preservative is volatilized by heat rious substance which is retained in in the drying and finishing of the coat- the recovered pulp and that migrates ed paper or paperboard. to the food, except as provided in regu- (b) The quantity used shall not ex- lations promulgated under sections 406 ceed the least amount reasonably re- and 409 of the act or (ii) has been used quired to accomplish the intended for shipping or handling any such sub- technical effect and shall not be in- stance. tended to nor, in fact, accomplish any physical or technical effect in the food § 176.300 Slimicides. itself. (a) Slimicides may be safely used in (c) The use of a preservative in any the manufacture of paper and paper- substance or article subject to any reg- board that contact food, in accordance ulation in parts 174, 175, 176, 177, 178 with the following prescribed condi- and § 179.45 of this chapter must comply tions: with any specifications and limitations (1) Slimicides are used as anti- prescribed by such regulation for the microbial agents to control slime in substance or article. the manufacture of paper and paper- board. § 176.250 Poly-1,4,7,10,13-pentaaza-15- (2) Subject to any prescribed limita- hydroxyhexadecane. tions, slimicides are prepared from one Poly-1,4,7,10,13-pentaaza-15-hydrox- or more of the slime-control substances yhexadecane may be safely used as a named in paragraph (c) of this section retention aid employed prior to the to which may be added optional adju- sheet-forming operation in the manu- vant substances as provided for under facture of paper and paperboard in- paragraph (d) of this section. tended for use in contact with food in (3) Slimicides are added to the proc- an amount not to exceed that nec- ess water used in the production of essary to accomplish the intended paper or paperboard, and the quantity physical or technical effect and not to added shall not exceed the amount nec- exceed 6 pounds per ton of finished essary to accomplish the intended paper or paperboard. technical effect.
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(b) To insure safe usage, the label or slimicides include substances subject labeling of slimicides shall bear ade- to prior sanction or approval for such quate directions for use. use and the following: (c) Slime-control substances per- mitted for use in the preparation of
List of substances Limitations
Acrolein. Alkenyl (C16ÐC18) dimethylethyl-ammonium bromide. n-Alkyl (C12ÐC18) 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. 3785Ð34Ð0] 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. 52Ð51Ð7) ...... At a maximum level of 0.6 pound per ton of dry weight fiber. β-Bromo-β-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 (C12ÐC18) benzylmethylammonium chloride. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691Ð65Ð7) .. 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. 1192Ð52Ð5) ...... For use only at levels not to exceed 10 milligrams per kilogram in the pulp slurry. 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 chlo- rine).. 4-(Diiodomethylsulfonyl) toluene (CAS Reg. No. 20018Ð09Ð01). 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. 34911Ð46Ð1). 2-Hydroxypropyl methanethiol sulfonate. 2-Mercaptobenzothiazole. Methylenebisbutanethiolsulfonate. Methylenebisthiocyanate. 2-Nitrobutyl bromoacetate [CA Reg. No. 32815Ð96Ð6] ...... At a maximum level of 0.15 pound per ton of dry weight fiber. N-[α-(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 55566Ð30Ð8). 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.
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(d) Adjuvant substances permitted to tended technical effect or exceed 15 be used in the preparation of slimicides percent by weight of the finished paper. include substances generally recog- (2) Conditions of use. The glassine and nized as safe for use in food, substances greaseproof papers are used for pack- generally recognized as safe for use in aging dry food or as the food-contact paper and paperboard, substances per- surface for dry food. mitted to be used in paper and paper- board by other regulations in this § 176.350 Tamarind seed kernel pow- chapter, and the following: der. Tamarind seed kernel powder may be Acetone. safely used as a component of articles Butlylene oxide. Dibutyl phthalate. intended for use in producing, manu- Didecyl phthalate. facturing, packing, processing, pre- N,N-Dimethylformamide. paring, treating, packaging, trans- Dodecyl phthalate. porting, or holding food, subject to the Ethanolamine. provisions of this section. Ethylene glycol. (a) Tamarind seed kernel powder is Ethylenediamine. the ground kernel of tamarind seed N-methyl-2-pyrrolidone (CAS Reg. No. 872– (Tamarindus indica L.) after removal of 50–4). the seed coat. a,a′-[Methylenebis[4-(1,1,3,3-tetramethyl- butyl)-o-phenylene]] bis[omega-hydroxypoly (b) It is used in the manufacture of (oxyethylene)] having 6–7.5 moles of ethyl- paper and paperboard. ene oxide per hydroxyl group. Monomethyl ethers of mono-, di-, and tri- PART 177—INDIRECT FOOD propylene glycol. ADDITIVES: POLYMERS Nonylphenol reaction product with 9 to 12 molecules of ethylene oxide. Octylphenol reaction product with 25 mol- Subpart A [Reserved] ecules of propylene oxide and 40 molecules of ethylene oxide. Subpart B—Substances for Use as Basic Components of Single and Repeated [42 FR 14554, Mar. 15, 1977, as amended at 42 Use Food Contact Surfaces FR 41854, Aug. 19, 1977; 44 FR 75627, Dec. 21, 1979; 46 FR 36129, July 14, 1981; 49 FR 5748, Sec. Feb. 15, 1984; 51 FR 19059, May 27, 1986; 51 FR 177.1010 Acrylic and modified acrylic plas- 43734, Dec. 4, 1986; 54 FR 18103, Apr. 27, 1989; tics, semirigid and rigid. 55 FR 31825, Aug. 6, 1990; 64 FR 46130, Aug. 24, 177.1020 Acrylonitrile/butadiene/styrene co– 1999; 64 FR 69900, Dec. 15, 1999; 65 FR 40497, polymer. June 30, 2000; 65 FR 70790, Nov. 28, 2000] 177.1030 Acrylonitrile/butadiene/styrene/ methyl methacrylate copolymer. § 176.320 Sodium nitrate-urea complex. 177.1040 Acrylonitrile/styrene copolymer. Sodium nitrate-urea complex may be 177.1050 Acrylonitrile/styrene copolymer modified with butadiene/styrene elas- safely used as a component of articles tomer. intended for use in producing, manu- 177.1060 n-Alkylglutarimide/acrylic copoly- facturing, packing, processing, pre- mers. paring, treating, packaging, trans- 177.1200 Cellophane. porting, or holding food, subject to the 177.1210 Closures with sealing gaskets for provisions of this section. food containers. (a) Sodium nitrate-urea complex is a 177.1211 Cross-linked polyacrylate copoly- clathrate of approximately two parts mers. 177.1240 1,4-Cyclohexylene dimethylene urea and one part sodium nitrate. terephthalate and 1,4-cyclohexylene (b) Sodium nitrate-urea complex con- 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. 177.1320 Ethylene-ethyl acrylate copoly- ticizer in glassine and greaseproof mers. paper. 177.1330 Ionomeric resins. (ii) The amount used does not exceed 177.1340 Ethylene-methyl acrylate copoly- that required to accomplish its in- mer resins.
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177.1345 Ethylene/1,3-phenylene oxyethylene 177.1970 Vinyl chloride-lauryl vinyl ether isophthalate/terephthalate copolymer. copolymers. 177.1350 Ethylene-vinyl acetate copolymers. 177.1980 Vinyl chloride-propylene copoly- 177.1360 Ethylene-vinyl acetate-vinyl alco- mers. hol copolymers. 177.1990 Vinylidene chloride/methyl acry- 177.1380 Fluorocarbon resins. late copolymers. 177.1390 Laminate structures for use at tem- 177.2000 Vinylidene chloride/methyl acry- peratures of 250 °F and above. late/methyl methacrylate polymers. 177.1395 Laminate structures for use at tem- peratures between 120 °F and 250° F. Subpart C—Substances for Use Only as 177.1400 Hydroxyethyl cellulose film, water- Components of Articles Intended for insoluble. Repeated Use 177.1420 Isobutylene polymers. 177.1430 Isobutylene-butene copolymers. 177.2210 Ethylene polymer, 177.1440 4,4′-Isopropylidenediphenol- chlorosulfonated. epichlorohydrin resins minimum molec- 177.2250 Filters, microporous polymeric. ular weight 10,000. 177.2260 Filters, resin-bonded. 177.1460 Melamine-formaldehyde resins in 177.2280 4,4′-Isopropylidenediphenol- molded articles. epichlorohydrin thermosetting epoxy 177.1480 Nitrile rubber modified acrylo- resins. nitrile-methyl acrylate copolymers. 177.2355 Mineral reinforced nylon resins. 177.1500 Nylon resins. 177.2400 Perfluorocarbon cured elastomers. 177.1520 Olefin polymers. 177.2410 Phenolic resins in molded articles. 177.1550 Perfluorocarbon resins. 177.2415 Poly(aryletherketone) resins. 177.1555 Polyarylate resins. 177.2420 Polyester resins, cross-linked. 177.1556 Polyaryletherketone resins. 177.2430 Polyether resins, chlorinated. 177.1560 Polyarylsulfone resins. 177.2440 Polyethersulfone resins. 177.1570 Poly-1-butene resins and butene/ 177.2450 Polyamide-imide resins. ethylene copolymers. 177.2460 Poly(2,6-dimethyl-1,4-phenylene) 177.1580 Polycarbonate resins. oxide resins. 177.1585 Polyestercarbonate resins. 177.2465 Polymethylmethacrylate/poly(tri 177.1590 Polyester elastomers. methoxysilylpropyl) methacrylate co- 177.1595 Polyetherimide resin. polymers. 177.1600 Polyethylene resins, carboxyl modi- 177.2470 Polyoxymethylene copolymer. fied. 177.2480 Polyoxymethylene homopolymer. 177.1610 Polyethylene, chlorinated. 177.2490 Polyphenylene sulfide resins. 177.1615 Polyethylene, fluorinated. 177.2500 Polyphenylene sulfone resins. 177.1620 Polyethylene, oxidized. 177.2510 Polyvinylidene fluoride resins. 177.1630 Polyethylene phthalate polymers. 177.2550 Reverse osmosis membranes. 177.1632 Poly (phenyleneterephthalamide) 177.2600 Rubber articles intended for re- resins. peated use. 177.1635 Poly(p-methylstyrene) and rubber- 177.2710 Styrene-divinylbenzene resins, modified poly(p-methylstyrene). cross-linked. 177.1637 Poly(oxy-1,2- 177.2800 Textiles and textile fibers. ethanediyloxycarbonyl-2,6- 177.2910 Ultra-filtration membranes. naphthalenediylcarbonyl) resins. AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. 177.1640 Polystyrene and rubber-modified polystyrene. SOURCE: 42 FR 14572, Mar. 15, 1977, unless 177.1650 Polysulfide polymer-polyepoxy res- otherwise noted. ins. EDITORIAL NOTE: Nomenclature changes to 177.1655 Polysulfone resins. part 177 appear at 61 FR 14482, Apr. 2, 1996. 177.1660 Poly (tetramethylene terephthalate). 177.1670 Polyvinyl alcohol film. Subpart A [Reserved] 177.1680 Polyurethane resins. 177.1810 Styrene block polymers. Subpart B—Substances for Use as 177.1820 Styrene-maleic anhydride copoly- mers. Basic Components of Single 177.1830 Styrene-methyl methacrylate co- and Repeated Use Food Con- polymers. tact Surfaces 177.1850 Textryls. 177.1900 Urea-formaldehyde resins in molded § 177.1010 Acrylic and modified acrylic articles. plastics, semirigid and rigid. 177.1950 Vinyl chloride-ethylene copoly- mers. Semirigid and rigid acrylic and modi- 177.1960 Vinyl chloride-hexene-1 copoly- fied acrylic plastics may be safely used mers. as articles intended for use in contact
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with food, in accordance with the fol- (i) List of minor monomers: lowing prescribed conditions. The Acrylamide. acrylic and modified acrylic polymers Acrylic acid or plastics described in this section 1,3-Butylene glycol dimethacrylate. also may be safely used as components 1,4-Butylene glycol dimethacrylate. of articles intended for use in contact Diethylene glycol dimethacrylate. with food. Diproplylene glycol dimethacrylate. (a) The optional substances that may Divinylbenzene. be used in the formulation of the Ethylene glycol dimethacrylate. Itaconic acid. semirigid and rigid acrylic and modi- Methacrylic acid. fied acrylic plastics, or in the formula- N-Methylolacrylamide. tion of acrylic and modified acrylic N-Methylolmethacrylamide. components of articles, include sub- 4-Methyl-1,4-pentanediol dimethacrylate. stances generally recognized as safe in Propylene glycol dimethacrylate. food, substances used in accordance Trivinylbenzene. with a prior sanction or approval, sub- (ii) List of minor monomers limited stances permitted for use in such plas- to use only in plastic articles intended tics by regulations in parts 170 through for repeated use in contact with food: 189 of this chapter, and substances identified in this paragraph. At least 50 Allyl methacrylate [Chemical Abstracts Service Registry No. 96–05–9] weight-percent of the polymer content tert-Butyl acrylate. of the acrylic and modified acrylic ma- tert-Butylaminoethyl methacrylate. terials used as finished articles or as sec-Butyl methacrylate. components of articles shall consist of tert-Butyl methacrylate. polymer units derived from one or Cyclohexyl methacrylate. more of the acrylic or methacrylic Dimethylaminoethyl methacrylate. monomers listed in paragraph (a)(1) of 2-Ethylhexyl methacrylate. Hydroxyethyl methacrylate. this section. Hydroxyethyl vinyl sulfide. (1) Homopolymers and copolymers of Hydroxypropyl methacrylate. the following monomers: Isobornyl methacrylate. Isobutyl methacrylate. n-Butyl acrylate. Isopropyl acrylate. n-Butyl methacrylate. Ethyl acrylate. Isopropyl methacrylate. 2-Ethylhexyl acrylate. Methacrylamide. Ethyl methacrylate. Methacrylamidoethylene urea. Methyl acrylate. Methacryloxyacetamidoethylethylene urea. Methyl methacrylate. Methacryloxyacetic acid. n-Propyl methacrylate. (2) Copolymers produced by copolym- 3,5,5-Trimethylcyclohexyl methacrylate. erizing one or more of the monomers (4) Polymers identified in paragraphs listed in paragraph (a)(1) of this section (a)(1), (2), and (3) of this section are with one or more of the following mixed together and/or with the fol- monomers: lowing polymers, provided that no Acrylonitrile. chemical reactions, other than addi- Methacrylonitrile. tion reactions, occur when they are α-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 this chapter. ed in paragraph (a)(3)(ii) of this section Polyvinyl chloride. are limited to use only in plastic arti- Vinyl chloride copolymers complying with cles intended for repeated use in con- § 177.1980. tact with food. Vinyl chloride-vinyl acetate copolymers.
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(5) Antioxidants and stabilizers iden- (1) Total nonvolatile extractives not tified in § 175.300(b)(3)(xxx) of this chap- to exceed 0.3 milligram per square inch ter and the following: of surface tested. (2) Potassium permanganate oxidiz- Di-tert-butyl-p-cresol. 2-Hydroxy-4-methoxybenzophenone. able distilled water and 8 and 50 per- 2-Hydroxy-4-methoxy-2- cent alcohol extractives not to exceed carboxybenzophenone. an absorbance of 0.15. 3-Hydroxyphenyl benzoate. (3) Ultraviolet-absorbing distilled p-Methoxyphenol. water and 8 and 50 percent alcohol ex- Methyl salicylate. tractives not to exceed an absorbance Octadecyl 3,5-di-tert-butyl-4-hydroxyhydro- of 0.30. cinnamate (CAS Reg. No. 2082–79–3): For (4) Ultraviolet-absorbing n-heptane use only: (1) At levels not exceeding 0.2 extractives not to exceed an absorb- percent by weight in semirigid and rigid ance of 0.10. acrylic and modified acrylic plastics, where the finished articles contact foods (c) Analytical methods—(1) Selection of containing not more than 15 percent alco- extractability conditions. These are to be hol; and (2) at levels not exceeding 0.01 per- chosen as provided in § 176.170(c) of this cent by weight in semirigid and rigid chapter. acrylic and modified acrylic plastics in- (2) Preparation of samples. Sufficient tended for repeated food-contact use where samples to allow duplicates of all ap- the finished article may be used for foods plicable tests shall be cut from the ar- containing more than 15 percent alcohol. ticles or formed from the plastic com- Phenyl salicylate. position under tests, as strips about 2.5 (6) Release agents: Fatty acids de- inches by about 0.85-inch wide by about rived from animal and vegetable fats 0.125-inch thick. The total exposed sur- and oils, and fatty alcohols derived face should be 5 square inches ±0.5- from such acids. square inch. The samples, after prepa- (7) Surface active agent: Sodium ration, shall be washed with a clean dodecylbenzenesulfonate. brush under hot tapwater, rinsed under (8) Miscellaneous materials: running hot tapwater (140 °F min- imum), rinsed with distilled water, and Di(2-ethylhexyl) phthalate, for use only as a flow promoter at a level not to exceed 3 air-dried in a dust-free area or in a des- weight-percent based on the monomers. iccator. Dimethyl phthalate. (3) Preparation of solvents. The water Oxalic acid, for use only as a polymerization used shall be double-distilled water, catalyst aid. prepared in a still using a block tin Tetraethylenepentamine, for use only as a condenser. The 8 and 50 percent (by vol- catalyst activator at a level not to exceed ume) alcohol solvents shall be prepared 0.5 weight-percent based on the monomers. from ethyl alcohol meeting the speci- Toluene. fications of the United States Pharma- Xylene. copeia XX and diluted with double-dis- (b) The semirigid and rigid acrylic tilled water that has been prepared in a and modified acrylic plastics, in the still using a tin block condenser. The 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
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average residue weight used as the gion of 544 to 552 mµ should be 1.16 but blank value in the total solids deter- must not be less than 1.05 nor more mination set out in paragraph (c)(6) of than 1.25. The absorbance in the 8 and this section. The residue for an accept- 50 percent alcohol must not be less able solvent sample shall not exceed 0.5 than 0.85 nor more than 1.15. milligram per 60 milliliters. (v) Duplicate permanganate test de- (ii) For acceptability in the ultra- terminations shall be run on samples of violet absorbers test, a sample of each distilled water and 8 and 50 percent al- solvent shall be scanned in an ultra- cohol solvents that have been exposed violet spectrophotometer in 5-centi- to the temperature-time conditions of meter silica spectrophotometric ab- the extraction test without the plastic sorption cells. The absorbance of the sample. The procedure shall be as de- distilled water when measured versus air in the reference cell shall not ex- scribed in paragraph (c)(7)(iv) of this ceed 0.03 at any point in the wave- section, except that the appropriate ex- length region of 245 to 310 mµ. The ab- posed solvent shall be substituted sorbance of the 8 percent alcohol when where the directions call for sample ex- measured versus distilled water in the tract. The average difference in the reference cell shall not exceed 0.01 at absorbances in the region of 544 to 552 any point in the wavelength region of mµ shall be used as a blank correction 245 to 310 mµ. The absorbance of the 50 for the determination of permanganate percent alcohol when measured versus oxidizable extractives according to distilled water in the reference cell paragraph (c)(7)(iv) of this section. shall not exceed 0.05 at any point in the (5) Extraction procedure. For each ex- wavelength region of 245 to 310 mµ. The traction, place a plastic sample in a absorbance of the heptane when meas- clean 25 millimeters × 200 millimeters ured versus distilled water in the ref- hard-glass test tube and add solvent erence cell shall not exceed 0.15 at 245, equal to 10 milliliters of solvent per 0.09 at 260, 0.04 at 270, and 0.02 at any square inch of plastic surface. This point in the wavelength region of 280 to amount will be between 45 milliliters µ 310 m . and 55 milliliters. The solvent must be (iii) Duplicate ultraviolet blank de- preequilibrated to the temperature of terminations shall be run on samples of the extraction test. Close the test tube each solvent that has been exposed to with a ground-glass stopper and expose the temperature-time conditions of the to the specified temperature for the extraction test without the plastic sample. An aliquot of the exposed sol- specified time. Cool the tube and con- vent shall be measured versus the un- tents to room temperature if nec- exposed solvent in the reference cell. essary. The average difference in the (6) Determination of total nonvolatile absorbances at any wavelength in the extractives. Remove the plastic strip region of 245 to 310 mµ shall be used as from the solvent with a pair of clean a blank correction for the ultraviolet forceps and wash the strip with 5 milli- absorbers measured at the same wave- liters of the appropriate solvent, add- length according to paragraph (c)(8)(ii) ing the washings to the contents of the of this section. test tube. Pour the contents of the test (iv) The acceptability of the solvents tube into a clean, weighed platinum for use in the permanganate test shall dish. Wash the tube with 5 milliliters be determined by preparing duplicate of the appropriate solvent and add the permanganate test blanks according to solvent to the platinum dish. Evapo- paragraph (c)(7)(iv) of this section. For rate the solvent to 2–5 milliliters on a this test, the directions referring to nonsparking, low-temperature the sample extract shall be dis- hotplate. Complete the evaporation in regarded. The blanks shall be scanned a 212 °F oven for 30 minutes. Cool the in 5-centimeter silica dish in a desiccator for 30 minutes and spectrophotometric cells in the spec- weigh to the nearest 0.1 milligram. Cal- trophotometer versus the appropriate culate the total nonvolatile extractives solvent as reference. The absorbance in distilled water in the wavelength re- as follows:
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− Erlenmeyer flask. Pipette exactly 3.0 Milligrams extractives = eb milliliters of 154 parts per million per square inch aqueous potassium permanganate solu- s tion into the p-methoxyphenol and ex- Extractives in parts eb actly 3.0 milliliters into the blank, in =×100 that order. Swirl both flasks to mix the per million s contents and then transfer aliquots where: from each flask into matched 5-centi- e=Total increase in weight of the dish, in meter spectrophotometric absorption milligrams. cells. The cells are placed in the spec- b=Blank value of the solvent in milligrams, trophotometer cell compartment with as determined in paragraph (c)(4)(i) of the p-methoxyphenol solution in the this section. reference beam. Spectrophotometric s=Total surface of the plastic sample in measurement is conducted as in para- square inches. graph (c)(7)(iv) of this section. The ab- (7) Determination of potassium per- sorbance reading in the region 544–552 manganate oxidizable extractives. (i) Pi- mµ should be 0.24 but must be not less pette 25 milliliters of distilled water than 0.12 nor more than 0.36. This test into a clean 125-milliliter Erlenmeyer shall be run in duplicate. For the pur- flask that has been rinsed several pose of ascertaining compliance with times with aliquots of distilled water. the limitations in paragraph (b)(2) of This is the blank. Prepare a distilled this section, the absorbance measure- water solution containing 1.0 part per ments obtained on the distilled water million of p-methoxyphenol (melting extracts according to paragraph point 54–56 °C, Eastman grade or equiv- (c)(7)(iv) of this section shall be multi- alent). Pipette 25 milliliters of this p- plied by a correction factor, calculated methoxyphenol solution into a rinsed as follows:
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 ance in the region 544–552 mµ should be (c)(7)(i) of this section is repeated ex- 0.25 but must be not less than 0.12 nor cept that, in this instance, the solvent more than 0.38. This test shall be run in shall be 50 percent alcohol. The absorb- duplicate. For the purpose of
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ascertaining compliance with the limi- hol extracts according to paragraph tations prescribed in paragraph (b)(2) of (c)(7)(iv) of this section shall be multi- this section, the absorbance measure- plied by a correction factor, calculated ments obtained on the 50 percent alco- 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 nate was added to the solutions. The extracts. Pipette 25 milliliters of the ap- height of the absorbance peak shall be propriate solvent into a clean, 125-mil- measured, corrected for the blank as liliter Erlenmeyer flask that has been determined in paragraph (c)(4)(v) of rinsed several times with aliquots of this section, and multiplied by the ap- the same solvent. This is the blank. propriate correction factor determined Into another similarly rinsed flask, pi- according to paragraph (c)(7) (i), (ii), pette 25 milliliters of the sample ex- and (iii) of this section. This test shall tract that has been exposed under the be run in duplicate and the two results conditions specified in paragraph (c)(5) averaged. of this section. Pipette exactly 3.0 mil- (8) Determination of ultraviolet-absorb- liliters of 154 parts per million aqueous ing extractives. (i) A distilled water so- potassium permanganate solution into lution containing 1.0 part per million the sample and exactly 3.0 milliliters of p-methoxyphenol (melting point 54 into the blank, in that order. Before °C–56 °C. Eastman grade or equivalent) use, the potassium permanganate solu- tion shall be checked as in paragraph shall be scanned in the region 360 to 220 µ (c)(7)(i) of this section. Both flasks are m in 5-centimeter silica spectrophoto- swirled to mix the contents, and then metric absorption cells versus a dis- aliquots from each flask are trans- tilled water reference. The absorbance ferred to matched 5-centimeter at the wavelength of maximum absorb- spectrophotometric absorption cells. ance (should be about 285 mµ) is about Both cells are placed in the spectro- 0.11 but must be not less than 0.08 nor photometer cell compartment with the more than 0.14. This test shall be run in sample solution in the reference beam. duplicate. For the purpose of The spectrophotometer is adjusted for ascertaining compliance with the limi- 0 and 100 percent transmittance at 700 tations prescribed in paragraph (b) (3) mµ. The spectrum is scanned on the ab- and (4) of this section, the absorbance sorbance scale from 700 mµ to 500 mµ in obtained on the extracts according to such a way that the region 544 mµ to paragraph (c)(8)(ii) of this section shall 552 mµ is scanned within 5 minutes to be multiplied by a correction factor, 10 minutes of the time that permanga- 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 tion is scanned in the wavelength re- been exposed under the conditions gion 360 to 220 mµ versus the appro- specified in paragraph (c)(5) of this sec- priate solvent reference in matched 5-
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centimeter silica spectrophotometric butadiene and 23 to 28 parts by weight absorption cells. The height of any ab- of styrene and (ii) 3 to 8 parts by sorption peak shall be measured, cor- weight of a graft polymer having the rected for the blank as determined in same composition range as the matrix paragraph (c)(4)(iii) of this section, and polymer. multiplied by the correction factor de- (b) Adjuvants. The copolymer identi- termined according to paragraph fied in paragraph (a) of this section (c)(8)(i) of this section. may contain adjuvant substances re- (d) In accordance with current good quired in its production. Such adju- manufacturing practice, finished vants may include substances gen- semirigid and rigid acrylic and modi- erally recognized as safe in food, sub- fied acrylic plastics, and articles con- stances used in accordance with prior taining these polymers, intended for repeated use in contact with food shall sanction, substances permitted in this be thoroughly cleansed prior to their part, and the following: first use in contact with food. Substance Limitations (e) Acrylonitrile copolymers identi- fied in this section shall comply with 2-Mercapto- ethanol ...... The finished copolymer shall the provisions of § 180.22 of this chap- contain not more than 100 ppm 2-mercaptoethanol ac- ter. rylonitrile adduct as deter- (f) The acrylic and modified acrylic mined by a method titled polymers identified in and complying ‘‘Analysis of Cycopac Resin for Residual β-(2- with this section, when used as compo- Hydroxyethylmercapto) pro- nents of the food-contact surface of an pionitrile,’’ which is incor- article that is the subject of a regula- porated by reference. Cop- tion in this part and in parts 174, 175, ies are available from the Bureau of Foods (HFSÐ 176, and 178 of this chapter, shall com- 200), Food and Drug Ad- ply with any specifications and limita- ministration, 200 C St. tions prescribed by such regulation for SW., Washington, DC 20204, or available for in- the article in the finished form in spection at the Office of which it is to contact food. the Federal Register, 800 North Capitol Street, NW., [42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. suite 700, Washington, DC 28, 1977, as amended at 43 FR 54927, Nov. 24, 20408. 1978; 45 FR 67320, Oct. 10, 1980; 46 FR 46796, Sept. 22, 1981; 49 FR 10108, Mar. 19, 1984; 49 FR (c) Specifications. (1) Nitrogen content 13139, Apr. 3, 1984; 50 FR 31045, July 24, 1985] of the copolymer is in the range of 16 § 177.1020 Acrylonitrile/butadiene/sty- to 18.5 percent as determined by Micro- rene co-polymer. Kjeldahl analysis. Acrylonitrile/butadiene/styrene co- (2) Residual acrylonitrile monomer polymer identified in this section may content of the finished copolymer arti- be safely used as an article or compo- cles is not more than 11 parts per mil- nent of articles intended for use with lion as determined by a gas all foods, except those containing alco- chromatographic method titled ‘‘De- hol, under conditions of use E, F, and G termination of Residual Acrylonitrile described in table 2 of § 176.170(c) of this and Styrene Monomers-Gas chapter. Chromatographic Internal Standard (a) Identity. For the purpose of this Method,’’ which is incorporated by ref- section, the acrylonitrile/butadiene/ erence. Copies are available from the styrene copolymer consists of: Center for Food Safety and Applied Nu- (1) Eighty-four to eighty-nine parts trition (HFS–200), Food and Drug Ad- by weight of a matrix polymer con- ministration, 200 C St. SW., Wash- taining 73 to 78 parts by weight of acry- ington, DC 20204, or available for in- lonitrile and 22 to 27 parts by weight of spection at the Office of the Federal styrene; and Register, 800 North Capitol Street, (2) Eleven to sixteen parts by weight NW., suite 700, Washington, DC 20408. of a grafted rubber consisting of (i) 8 to (d) Extractive limitations. (1) Total 13 parts of butadiene/styrene elastomer nonvolatile extractives not to exceed containing 72 to 77 parts by weight of
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0.0005 milligram per square inch sur- a grafted rubber consisting of (i) 16 to face area when the finished food con- 20 parts of butadiene/styrene/elastomer tact article is exposed to distilled containing 72 to 77 parts by weight of water, 3 percent acetic acid, or n- butadiene and 23 to 28 parts by weight heptane for 8 days at 120 °F. of styrene and (ii) 5 to 10 parts by (2) The finished food-contact article weight of a graft polymer having the shall yield not more than 0.0015 milli- same composition range as the matrix gram per square inch of acrylonitrile polymer. monomer when exposed to distilled (b) Adjuvants. The copolymer identi- water and 3 percent acetic acid at 150 fied in paragraph (a) of this section °F for 15 days when analyzed by a po- may contain adjuvant substances re- larographic method titled ‘‘Extracted quired in its production. Such adju- Acrylonitrile by Differential Pulse Po- vants may include substances gen- larography,’’ which is incorporated by erally recognized as safe in food, sub- reference. Copies are available from stances used in accordance with prior the Center for Food Safety and Applied sanction, substances permitted under Nutrition (HFS–200), Food and Drug applicable regulations in this part, and Administration, 200 C St. SW., Wash- the following: ington, DC 20204, or available for in- spection at the Office of the Federal Substances Limitations Register, 800 North Capitol Street, 2ÐMercaptoethanol ...... The finished copolymer shall NW., suite 700, Washington, DC 20408. contain not more than 800 (e) Acrylonitrile copolymers identi- ppm 2Ðmercaptoethanol fied in this section shall comply with acrylonitrile adduct as de- termined by a method titled the provisions of § 180.22 of this chap- ‘‘Analysis of Cycopac ter. Resin for Residual βÐ(2Ð (f) Acrylonitrile copolymers identi- Hydroxyethylmercapto) pro- fied in this section are not authorized pionitrile,’’ which is incor- porated by reference. Cop- to be used to fabricate beverage con- ies are available from the tainers. Bureau of Foods (HFSÐ 200), Food and Drug Ad- [42 FR 14572, Mar. 15, 1977, as amended at 42 ministration, 200 C St. FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, SW., Washington, DC 1982; 54 FR 24897, June 12, 1989] 20204, or available for in- spection at the Office of § 177.1030 Acrylonitrile/butadiene/sty- the Federal Register, 800 North Capitol Street, NW., rene/methyl methacrylate copoly- suite 700, Washington, DC mer. 20408. Acrylonitrile/butadiene/styrene/ methyl methacrylate copolymer iden- (c) Specifications. (1) Nitrogen content tified in this section may be safely of the copolymer is in the range of 13.0 used as an article or component of arti- to 16.0 percent as determined by Micro- cles intended for use with food identi- Kjeldahl analysis. fied in table 1 of § 176.170(c) of this (2) Residual acrylonitrile monomer chapter as Type I, II, III, IVA, IVB, V, content of the finished copolymer arti- 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, 200 C St. SW., Wash- parts by weight of acrylonitrile, 25 to ington, DC 20204, or available for in- 30 parts by weight of styrene and 4 to spection 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.
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(d) Extractive limitations. (1) Total § 177.1040 Acrylonitrile/styrene copoly- nonvolatile extractives not to exceed mer. 0.0005 milligram per square inch sur- Acrylonitrile/styrene copolymers face area of the food-contact article identified in this section may be safely when exposed to distilled water, 3 per- used as a component of packaging ma- cent acetic acid, 50 percent ethanol, terials subject to the provisions of this and n-heptane for 10 days at 120 °F. (2) The finished food-contact article section. shall yield not more than 0.0025 milli- (a) Identity. For the purposes of this gram per square inch of acrylonitrile section acrylonitrile/styrene copoly- monomer when exposed to distilled mers are basic copolymers meeting the water, 3 percent acetic acid and n- specifications prescribed in paragraph heptane at 190 °F for 2 hours, cooled to (c) of this section. 120 °F (80 to 90 minutes) and main- (b) Adjuvants. (1) The copolymers tained at 120 °F for 10 days when ana- identified in paragraph (c) of this sec- lyzed by a polarographic method titled tion may contain adjuvant substances ‘‘Extracted Acrylonitrile by Differen- required in their production, with the tial Pulse Polarography,’’ which is in- exception that they shall not contain corporated by reference. Copies are mercaptans or other substances which available from the Center for Food form reversible complexes with acryl- Safety and Applied Nutrition (HFS– onitrile monomer. Permissible adju- 200), Food and Drug Administration, vants may include substances gen- 200 C St. SW., Washington, DC 20204, or erally recognized as safe in food, sub- available for inspection at the Office of stances used in accordance with prior the Federal Register, 800 North Capitol sanction, substances permitted under Street, NW., suite 700, Washington, DC applicable regulations in this part, and 20408. those authorized in paragraph (b)(2) of (e) Acrylonitrile copolymers identi- this section. fied in this section shall comply with (2) The optional adjuvants for the ac- the provisions of § 180.22 of this chap- rylonitrile/styrene copolymer identi- ter. fied in paragraphs (c) (1) and (3) of this (f) Acrylonitrile copolymers identi- section are as follows: fied in this section are not authorized to be used to fabricate beverage con- Substances Limitation tainers. Condensation polymer of toluene 0.15 pct maximum. [42 FR 14572, Mar. 15, 1977, as amended at 42 sulfonamide and formaldehyde. FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, 1982; 54 FR 24898, June 12, 1989] (c) Specifications.
Maximum re- sidual acrylo- nitrile 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 66Ð area of the food contact article weight is 30,000.1 72 parts by weight of acrylo- when exposed to distilled water nitrile and 28Ð34 parts by weight and 3 pct acetic acid for 10 d at of styrene; for use with food of 66 °C (150 °F). Type VIÐB 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.
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Maximum re- sidual acrylo- nitrile 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
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 45Ð 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 35Ð55 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 66Ð 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 28Ð34 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 VIÐA and VIÐB 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 mo- lecular 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 (HFSÐ200), 200 C Street SW., Washington, DC 20204, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. 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 (HFSÐ200), 200 C Street SW., Washington, DC 20204, 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 DÐ1434Ð82, ‘‘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 (HFSÐ200), 200 C Street SW., Washington, DC 20204, 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- safely used as a component of bottles polymers identified in this section intended for use with foods identified shall comply with the provisions of in table I of § 176.170(c) of this chapter § 180.22 of this chapter. as Type VI–B under conditions for use (e) Acrylonitrile copolymer identified E, F, or G described in table 2 of in this section may be used to fabricate § 176.170(c) of this chapter. beverage containers only if they com- (a) Identity. For the purpose of this ply with the specifications of item 3 in section, acrylonitrile/styrene copoly- paragraph (c) of this section. mer modified with butadiene/styrene [42 FR 14572, Mar. 15, 1977, as amended at 42 elastomer consists of a blend of: FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, (1) 82–88 parts by weight of a matrix 1982; 49 FR 36643, Sept. 19, 1984; 52 FR 33803, copolymer produced by polymerization Sept. 8, 1987] of 77–82 parts by weight of acrylonitrile and 18–23 parts of styrene; and § 177.1050 Acrylonitrile/styrene copoly- (2) 12–18 parts by weight of a grafted mer modified with butadiene/sty- rubber consisting of (i) 8–12 parts of bu- rene elastomer. tadiene/styrene elastomer containing Acrylonitrile/styrene copolymer 77–82 parts by weight of butadiene and modified with butadiene/styrene elas- 18–23 parts by weight of styrene and (ii) tomer identified in this section may be
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4–6 parts by weight of a graft copoly- ard Method,’’ which is incorporated by mer consisting of 70–77 parts by weight reference. Copies are available from of acrylonitrile and 23–30 parts by the Center for Food Safety and Applied weight of styrene. Nutrition (HFS–200), Food and Drug (b) Adjuvants. The modified copoly- Administration, 200 C St. SW., Wash- mer identified in paragraph (a) of this ington, DC 20204, or available for in- section may contain adjuvant sub- spection at the Office of the Federal stances required in its production. Register, 800 North Capitol Street, Such adjuvants may include substances NW., suite 700, Washington, DC 20408. generally recognized as safe in food, (d) Extractives limitations. The fol- substances used in accordance with lowing extractives limitations are de- prior sanction, substances permitted termined by an infrared spectrophoto- under applicable regulations in this metric method titled ‘‘Infrared part, and the following: Spectrophotometric Determination of Polymer Extracted from Borex 210 Substances Limitations Resin Pellets,’’ which is incorporated n-Dodecylmercaptan ...... The finished copolymer shall by reference. Copies are available from contain not more than 500 the Center for Food Safety and Applied parts per million (ppm) dodecylmercaptan as Nutrition (HFS–200), Food and Drug dodecylmercapto- Administration, 200 C St. SW., Wash- propionitrile as determined ington, DC 20204, or available for in- by the method titled, ‘‘De- spection at the Office of the Federal termination of β-Dodecyl- mercaptopropionitrile in Register, 800 North Capitol Street, NRÐ16 Polymer,’’ which is NW., suite 700, Washington, DC 20408, incorporated by reference. and are applicable to the modified co- Copies are available from the Center for Food Safety polymers in the form of particles of a and Applied Nutrition size that will pass through a U.S. (HFSÐ200), Food and Drug Standard Sieve No. 6 and that will be Administration, 200 C St., held on a U.S. Standard Sieve No. 10: SW., Washington, DC 20204, or available for in- (1) The extracted copolymer shall not spection at the Office of exceed 2.0 ppm in aqueous extract ob- the Federal Register, 800 tained when a 100-gram sample of co- North Capitol Street, NW., suite 700, Washington, DC polymer is extracted with 250 milli- 20408. liters of freshly distilled water at reflux temperature for 2 hours. (c) Specifications. (1) Nitrogen content (2) The extracted copolymer shall not of the modified copolymer is in the exceed 0.5 ppm in n-heptane when a 100- range of 17.7–19.8 percent. gram sample of the basic copol-ymer is (2) Intrinsic viscosity of the matrix extracted with 250 milliliters spectral copolymer in butyrolactone is not less grade n-heptane at reflux temperature than 0.5 deciliter/gram at 35 °C, as de- for 2 hours. termined by the method titled ‘‘Molec- (e) Accelerated extraction end test. The ular Weight of Matrix Copolymer by modified copolymer shall yield acrylo- Solution Viscosity,’’ which is incor- nitrile monomer not in excess of 0.4 porated by reference. Copies are avail- ppm when tested as follows: able from the Center for Food Safety (1) The modified copolymer shall be and Applied Nutrition (HFS–200), Food in the form of eight strips 1⁄2 inch by 4 and Drug Administration, 200 C St. inches by .03 inch. SW., Washington, DC 20204, or available (2) The modified copolymer strips for inspection at the Office of the Fed- shall be immersed in 225 milliliters of 3 eral Register, 800 North Capitol Street, percent acetic acid in a Pyrex glass NW., suite 700, Washington, DC 20408. pressure bottle. (3) Residual acrylonitrile monomer (3) The pyrex glass pressure bottle is content of the modified copolymer ar- then sealed and heated to 150 °F in ei- ticles is not more than 11 ppm as deter- ther a circulating air oven or a thermo- mined by a gas chromatographic meth- stat controlled bath for a period of 8 od titled ‘‘Determination of Residual days. Acrylonitrile and Styrene Monomers- (4) The Pyrex glass pressure bottle is Gas Chromatographic Internal Stand- then removed from the oven or bath
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and cooled to room temperature. A by micro-Kjeldahl analysis, shall not sample of the extracting solvent is exceed 8 percent. then withdrawn and analyzed for acry- (d) Limitations. (1) The n-alkylglutar- lonitrile monomer by a gas imide/acrylic copolymers in the fin- chromatographic method titled ‘‘Gas- ished form in which they shall contact Solid Chromatographic Procedure for food, when extracted with the solvent Determining Acrylonitrile Monomer in or solvents characterizing the type of Acrylonitrile-Containing Polymers and food and under the conditions of time Food Simulating Solvents,’’ which is and temperature described in tables 1 incorporated by reference. Copies, are and 2 of § 176.170(c) of this chapter, available from the Center for Food shall yield extractives not to exceed Safety and Applied Nutrition (HFS– the limitations of § 177.1010(b) of this 200), Food and Drug Administration, chapter, when prepared as strips, as de- 200 C St. SW., Washington, DC 20204, or scribed in § 177.1010(c)(2) of this chapter. available for inspection at the Office of (2) The n-alkylglutarimide/acrylic co- the Federal Register, 800 North Capitol polymers shall not be used as polymer Street, NW., suite 700, Washington, DC modifiers in vinyl chloride homo- or 20408. copolymers. (e) Conditions of use. The n- (f) Acrylonitrile copolymers identi- alkylglutarimide/acrylic copolymers fied in this section shall comply with are used as articles or components of the provisions of § 180.22 of this chap- articles (other than articles composed ter. of vinyl chloride homo- or copolymers) (g) Acrylonitrile copolymers identi- intended for use in contact with all fied in this section are not authorized foods except beverages containing to be used to fabricate beverage con- more than 8 percent alcohol under con- tainers. ditions of use D, E, F, and G as de- [42 FR 14572, Mar. 15, 1977, as amended at 42 scribed in table 2 of § 176.170(c) of this FR 48544, Sept. 23, 1977; 47 FR 11841, Mar. 19, chapter. 1982; 47 FR 16775, Apr. 20, 1982; 54 FR 24898, [54 FR 20382, May 11, 1989, as amended at 58 June 12, 1989] FR 17098, Apr. 1, 1993]
§ 177.1060 n-Alkylglutarimide/acrylic § 177.1200 Cellophane. copolymers. Cellophane may be safely used for n-Alkylglutarimide/acrylic copoly- packaging food in accordance with the mers identified in this section may be following prescribed conditions: safely used as articles or components (a) Cellophane consists of a base of articles intended for use in contact sheet made from regenerated cellulose with food subject to provisions of this to which have been added certain op- section and part 174 of this chapter. tional substances of a grade of purity (a) Identity. For the purpose of this suitable for use in food packaging as section, n-alkylglutarimide/acrylic co- constituents of the base sheet or as polymers are copolymers obtained by coatings applied to impart desired reaction of substances permitted by technological properties. § 177.1010(a) (1), (2), and (3) with the fol- (b) Subject to any limitations pre- lowing substance: Monomethylamine scribed in this part, the optional sub- (CAS Reg. No. 74–89–5), to form n- stances used in the base sheet and methylglutarimide/acrylic copolymers. coating may include: (b) Adjuvants. The copolymers identi- (1) Substances generally recognized fied in paragraph (a) of this section as safe in food. may contain adjuvant substances re- (2) Substances for which prior ap- quired in their production. The op- proval or sanctions permit their use in tional adjuvant substances required in cellophane, under conditions specified the production of the basic polymer in such sanctions and substances listed may include substances permitted for in § 181.22 of this chapter. such use by applicable regulations, as (3) Substances that by any regulation set forth in part 174 of this chapter. promulgated under section 409 of the (c) Specifications. Maximum nitrogen act may be safely used as components content of the copolymer determined of cellophane.
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(4) Substances named in this section (c) List of substances: and further identified as required.
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 ex- ceed a total of 0.3 percent by weight of the finished pack- aging 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. Coconut oil fatty acid (C12ÐC18) diethanolamide, coconut oil For use only as an adjuvant employed during the processing of fatty acid (C12ÐC18) diethanolamine soap, and cellulose pulp used in the manufacture of cellophane base diethanolamine mixture having total alkali (calculated as po- sheet. tassium hydroxide) of 16Ð18% and having an acid number of 25Ð35. 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 an- hydride. 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 (C8ÐC18) 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 per- cent by weight of the coating solids in vinylidene chloride co- polymer waterproof coatings prepared from vinylidene chlo- ride 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 ethylene- diamine such that the finished mixture has a melting point of 212°Ð228 °F., as determined by ASTM method D127Ð60 (‘‘Standard Method of Test for Melting Point of Petrolatum and Microcrystalline Wax’’ (Revised 1960), which is incor- porated 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.
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Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)
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, so- dium. Maleic acid ...... 1 percent. Maleic acid adduct of butadienestyrene copolymer. Melamine formaldehyde ...... As the basic polymer. 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-eth- ylamine, imino-bis-propylamine, methyl alcohol, polyamines made by reacting ethylenediamine or trimethylenediamine with dichloroethane or dichloropropane, sulfanilic acid, tetraethylenepentamine, triethanolamine, triethylenetetra- mine. Methyl ethyl ketone ...... Residue limit 0.1 percent Methyl hydrogen siloxane ...... 0.1 percent as the basic polymer. α-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1 α- 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. 62362Ð49Ð6). 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 percentÐ12.2 percent nitrogen. Nylon resins complying with ¤ 177.1500. n-Octyl alcohol ...... For use only as a defoaming agent in the manufacture of cello- phane 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 2,000Ð10,200; For use only as an adjuvant in vinylidene chloride copolymer bromine number range 210Ð320). coatings. Polycarbonate resins complying with ¤ 177.1580.
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Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)
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 °CÐ92 °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-con- tact 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 1,900Ð9,000). lulose pulp used in the manufacture of cellophane base sheet. Polypropylene complying with ¤ 177.1520. Polystyrene ...... As the basic polymer. Polyvinyl acetate ...... Do. Polyvinyl alcohol (minimum viscosity of 4 percent aqueous so- lution 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 sol- ids except when used as provided in ¤ 178.3740 of this chapter Urea (carbamide).
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Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)
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-eth- ylamine, 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 meth- acrylate, 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 stances identified in § 175.300(b) of this this section covered by a specific food chapter, with the exception of para- additive regulation must meet any graph (b)(3) (v), (xxxi), and (xxxii) of specifications in that regulation. that section, and from other optional (e) Acrylonitrile copolymers identi- substances, including the following: fied in this section shall comply with (1) Substances generally recognized the provisions of § 180.22 of this chap- as safe in food. ter. (2) Substances used in accordance [42 FR 14572, Mar. 15, 1977, as amended at 47 with the provisions of a prior sanction FR 11842, Mar. 19, 1982; 64 FR 57978, Oct. 28, or approval within the meaning of sec- 1999] tion 201(s) of the act. (3) Substances that are the subject of § 177.1210 Closures with sealing gas- kets for food containers. regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter and used in Closures with sealing gaskets may be accordance with the conditions pre- safely used on containers intended for scribed. use in producing, manufacturing, pack- ing, processing, preparing, treating, (4) Substances identified in para- packaging, transporting, or holding graph (b)(5) of this section, used in food in accordance with the following amounts not to exceed those required prescribed conditions: to accomplish the intended physical or (a) Closures for food containers are technical effect and in conformance manufactured from substances gen- with any limitation provided; and fur- erally recognized as safe for contact ther provided that any substance em- with food; substances that are subject ployed in the production of closure- to the provisions of prior sanctions; sealing gasket compositions that is the substances authorized by regulations subject of a regulation in parts 174, 175, in parts 174, 175, 176, 177, 178 and § 179.45 176, 177, 178 and § 179.45 of this chapter of this chapter; and closure-sealing conforms with the identity or speci- gaskets, as further prescribed in this fications prescribed. section. (5) Substances that may be employed (b) Closure-sealing gaskets and over- in the manufacture of closure-sealing all discs are formulated from sub- gaskets include:
TABLE 1
Limitations (expressed as percent by weight of closure-sealing List of substances gasket composition)
Arachidy-l-behenyl amide (C20ÐC22fatty acid amides) ...... 5 percent. Azodicarbonamide ...... 1. 2 percent.
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TABLE 1—Continued
Limitations (expressed as percent by weight of closure-sealing List of substances gasket composition)
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 1646Ð81, ‘‘Standard Test Method for Rubber—Viscosity and Vulcanization Characteristics (Moon- ey Viscometer),’’ which is incorporated by reference in ac- cordance 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 (HFSÐ200), Food and Drug Ad- ministration, 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 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. 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. 006422Ð86Ð2). .... 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, IVÐ B, VIÐA, VIÐB, VIÐC (up to 15 percent alcohol by volume), VIIÐB, 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-seal- ing gasket compositions used in contact with non-fatty foods containing no more than 8 percent of alcohol. Di-β-naphthyl-p-phenylenediamine ...... 1 percent. Dipentamethylenethiurametetrasulfide ...... 0.4 percent; for use only in vulcanized natural or synthetic rub- ber gasket compositions. Eicosane (technical grade) (water-white mixture of predomi- nantly straight-chain paraffin hydrocarbons averaging 20 car- bon 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 con- tain 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 vis- cosity of 35 as determined by the method described in ¤ 177.1520(d)(6).
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TABLE 1—Continued
Limitations (expressed as percent by weight of closure-sealing List of substances gasket composition)
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. 68411Ð46Ð1) ... 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). α-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. 2750Ð3000. 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 26375Ð23Ð5).. gasket compositions used in contact with food types VIÐA and VIÐC (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 composi- tions 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 ca- pacity 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 ex- ceed 4 percent by weight of the elastomer content of the rubber gasket composition. Tallow, sulfated ...... 1 percent. Tin-zinc stearate ...... 2 percent.
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TABLE 1—Continued
Limitations (expressed as percent by weight of closure-sealing List of substances gasket composition)
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 rub- ber gasket compositions.
TABLE 2—MAXIMUM EXTRACTIVES TOLERANCES cork, or glass that forms a part of the [In parts per million] food-contact surface of the assembly, when extracted on a suitable glass con- Chloro- Chloro- Chloro- tainer with a solvent or solvents char- form form form Type of closure-sealing gas- fraction fraction fraction acterizing the type of foods, and under ket composition of water of of alco- conditions of time and temperature extrac- heptane hol ex- tives extrac- tractives characterizing the conditions of its use tives as determined from tables 3 and 4 shall 1. Plasticized polymers, in- yield net chloroform-soluble extrac- cluding unvulcanized or tives (corrected for zinc as zinc oleate) vulcanized or otherwise not to exceed the tolerances specified cured natural and syn- thetic rubber formed in in table 2, calculated on the basis of place as overall discs or the water capacity of the container on annular rings from a hot which the closure is to be used. Employ melt, solution, plastisol, organisol, mechanical dis- the analytical method described in persion, or latex ...... 50 500 50 § 175.300 of this chapter, adapting the 2. Preformed overall discs procedural details to make the method or annular rings of plasti- cized polymers, including applicable to closures; such as, for ex- unvulcanized natural or ample, placing the closed glass con- synthetic rubber ...... 50 250 50 tainer on its side to assure contact of 3. Preformed overall discs the closure’s food-contacting surface or annular rings of vulcan- ized plasticized polymers, with the solvent. including natural or syn- thetic rubber ...... 50 50 50 TABLE 3—TYPES OF FOOD 4. Preformed overall discs I. Nonacid (pH above 5.0), aqueous products; may contain or annular rings of poly- salt or sugar or both, and including oil-in-water emulsions meric or resinous-coated of low- or high-fat content. paper, paperboard, plas- II. Acidic (pH 5.0 or below), aqueous products; may contain tic, or metal foil substrates 50 250 50 5. Closures with sealing salt or sugar or both, and including oil-in-water emulsions gaskets or sealing com- of low- or high-fat content. positions as described in III. Aqueous, acid or nonacid products containing free oil or 1, 2, 3, and 4, and includ- fat; may contain salt, and including water-in-oil emulsions ing paper, paperboard, of low- or high-fat content. and glassine used for dry IV. Dairy products and modifications: foods only ...... (1 )(1 )(1 ) A. Water-in-oil emulsions, high- or low-fat. B. Oil-in-water emulsions, high- or low-fat. 1 Extractability tests not applicable. V. Low-moisture fats and oils. (c) The closure assembly to include VI. Beverages: the sealing gasket or sealing com- A. Containing alcohol. B. Nonalcoholic. pound, together with any polymeric or VII. Bakery products. resinous coating, film, foil, natural 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, IVÐB ...... 250 °F, 2 hr ...... (e.g., over 212 °F). III, IVÐA, VII ...... do ...... 150 °F, 2 hr. B. Boiling water-sterilized ...... II ...... 212 °F, 30 min ...... III, VII ...... do ...... 120 °F, 30 min.
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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—Continued
Types of food (see Extractant Conditions of use table 3) Water 2 Heptane 12 8 percent alcohol 2
C. Hot filled or pasteurized above 150 II, IVÐB ...... Fill boiling, cool to . °F. III, IVÐA ...... 100 °F. 120 °F, 15 min. V ...... do ...... do. D. Hot filled or pasteurized below 150 II, IVÐB, VIÐB ...... 150 °F, 2 hr ...... °F. III, IVÐA ...... do ...... 100 °F, 30 min. 150 °F, 2 hr V ...... do ...... VIÐA ...... E. Temperature filled and stored (no II, IVÐB, VIÐB ...... 120 °F, 24 hr ...... thermal treatment in the container). III, IVÐA ...... do ...... 70 °F, 30 min. 120 °F, 24 hr. V ...... do ...... VIÐA ...... F. Refrigerated storage (no thermal I, II, III, IVÐA, IVÐB, 70 °F, 48 hr ...... 70 °F, 30 min ...... treatment). VIÐB, VII. 70 °F, 48 hr. VIÐA ...... G. Frozen storage (no thermal treat- I, II, III, IVÐB, 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. [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 nized as safe in food, and substances copolymers. used in accordance with a prior sanc- Cross-linked polyacrylate copoly- tion or approval. mers identified in paragraph (a) of this (c) Extractives limitations. The copoly- section may be safely used as articles mers identified in paragraph (a) of this or components of articles intended for section, in the finished form in which use in contact with food in accordance they will contact food, must yield low with the following prescribed condi- molecular weight (less than 1,000 Dal- tions: tons) extractives of no more than 0.15 (a) Identity. For the purpose of this percent by weight of the total polymer section, the cross-linked polyacrylate when extracted with 0.2 percent by copolymers consist of: weight of aqueous sodium chloride so- (1) The grafted copolymer of cross- lution at 20 °C for 24 hours. The low linked sodium polyacrylate identified molecular weight extractives shall be as 2-propenoic acid, polymers with N,N- determined using size exclusion chro- di-2-propenyl-2-propen-1-amine and matography or an equivalent method. hydrolyzed polyvinyl acetate, sodium When conducting the extraction test, salts, graft (CAS Reg. No. 166164–74–5); the copolymer, with no other absorp- or tive media, shall be confined either in (2) 2-propenoic acid, polymer with 2- a finished absorbent pad or in any suit- ethyl-2-(((1-oxo-2-pro- able flexible porous article, (such as a penyl)oxy)methyl)-1,3-propanediyl di-2- ‘‘tea bag’’ or infuser), under an applied propenoate and sodium 2-propenoate pressure of 0.15 pounds per square inch (CAS Reg. No. 76774–25–9). (for example, a 4x6 inch square pad is (b) Adjuvants. The copolymers identi- subjected to a 1.6 kilograms applied fied in paragraph (a) of this section mass). The solvent used shall be at may contain optional adjuvant sub- least 60 milliliters aqueous sodium stances required in the production of chloride solution per gram of copoly- such copolymers. The optional adju- mer. vant substances may include sub- (d) Conditions of use. The copolymers stances permitted for such use by regu- identified in paragraph (a)(1) of this lations in parts 170 through 179 of this section are limited to use as a fluid ab- chapter, substances generally recog- sorbent in food-contact materials used
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in the packaging of frozen or refrig- surfaces, subject to the provisions of erated poultry. The copolymers identi- such regulation. fied in paragraph (a)(2) of this section (e) The copolymer conforms with the are limited to use as a fluid absorbent following specifications: in food-contact materials used in the (1) The copolymer, when extracted packaging of frozen or refrigerated with distilled water at reflux tempera- meat and poultry. ture for 2 hours, yields total extrac- tives not to exceed 0.05 percent. [64 FR 28098, May 25, 1999, as amended at 65 (2) The copolymer, when extracted FR 16817, Mar. 30, 2000] with ethyl acetate at reflux tempera- ture for 2 hours, yields total extrac- § 177.1240 1,4-Cyclohexylene dimethylene terephthalate and 1,4- tives not to exceed 0.7 percent. cyclohexylene dimethylene (3) The copolymer, when extracted isophthalate copolymer. with n-hexane at reflux temperature for 2 hours, yields total extractives not Copolymer of 1,4-cyclohexylene to exceed 0.05 percent. dimethylene terephthalate and 1,4- cyclohexylene dimethylene isophtha- [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, late may be safely used as an article or 1984, as amended at 55 FR 34555, Aug. 23, 1990] component of articles used in pro- ducing, manufacturing, packing, proc- § 177.1310 Ethylene-acrylic acid co- polymers. essing, preparing, treating, packaging, transporting, or holding food, subject The ethylene-acrylic acid copolymers to the provisions of this section: identified in paragraph (a) of this sec- (a) The copolymer is a basic poly- tion may be safely used as components ester produced by the catalytic con- of articles intended for use in contact densation of dimethyl terephthalate with food subject to the provisions of and dimethyl isophthalate with 1,4- this section. cyclohexanedimethanol, to which may (a) The ethylene-acrylic acid copoly- have been added certain optional sub- mers consist of basic copolymers pro- stances required in its production or duced by the copolymerization of added to impart desired physical and ethylene and acrylic acid such that the technical properties. finished basic copolymers contain no more than: (b) The quantity of any optional sub- (1) 10 weight-percent of total polymer stance employed in the production of units derived from acrylic acid when the copolymer does not exceed the used in accordance with paragraph (b) amount reasonably required to accom- of this section; and plish the intended physical or technical (2) 25 weight-percent of total polymer effect or any limitation further pro- units derived from acrylic acid when vided. used in accordance with paragraph (c) (c) Any substance employed in the of this section. production of the copolymer that is the (b) The finished food-contact articles subject of a regulation in parts 174, 175, made with no more than 10 percent 176, 177, 178 and § 179.45 of this chapter total polymer units derived from acryl- 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
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(2) The net acidified chloroform-solu- the food-contact or interior core layer ble extractives from paper and paper- of multilaminate food-contact articles. board complying with § 176.170 of this (2) The polymers may be safely used chapter may be corrected for wax, pet- as food-contact materials at tempera- rolatum, and mineral oil as provided in tures not to exceed 121 °C (250 °F). § 176.170(d)(5)(iii)(b) of this chapter. (c) Specifications. (1) Food-contact If the finished food-contact article is layers formed from the basic copoly- itself the subject of a regulation in mer identified in paragraph (a) of this parts 174, 175, 176, 177, 178, and § 179.45 of section shall be limited to a thickness this chapter, it shall also comply with of not more than 0.01 centimeter (0.004 any specifications and limitations pre- inch). scribed for it by that regulation. (2) The copolymers identified in para- (c) The finished food-contact layer graph (a) of this section shall have a made with basic copolymers containing melt index not greater than 500 as de- more than 10 weight-percent but no termined by ASTM method D1238–82, more than 25 weight-percent of total condition E ‘‘Standard Test Method for polymer units derived from acrylic Flow Rates of Thermoplastics by Ex- acid and with a maximum thickness of trusion Plastometer,’’ which is incor- 0.0025 inch (2.5 mils) may be used in porated by reference in accordance contact with food types I, II, IVB, VIA, with 5 U.S.C. 552(a) and 1 CFR part 51. VIB, VIIB, and VIII identified in table Copies may be obtained from the Amer- 1 of § 176.170(c) of the chapter under ican Society for Testing Materials, 1916 conditions of use B through H as de- Race St., Philadelphia, PA 19103, or scribed in table 2 of § 176.170(c) of this may be examined at the Center for chapter, and in contact with food types Food Safety and Applied Nutrition III, IVA, V, VIIA, and IX identified in (HFS–200), Food and Drug Administra- table 1 of § 176.170(c) of this chapter tion, 200 C St. SW., Washington, DC, or under conditions of use E through G as at the Office of the Federal Register, described in table 2 of § 176.170(c) of this 800 North Capitol St. NW., suite 700, chapter. Washington, DC. (d) The provisions of this section are (3) The basic copolymer identified in not applicable to ethylene-acrylic acid paragraph (a) of this section, when ex- copolymers used in food-packaging ad- tracted with the solvent or solvents hesives complying with § 175.105 of this characterizing the type of food and chapter. under the conditions of time and tem- perature characterizing the conditions [42 FR 14572, Mar. 15, 1977, as amended at 51 of its intended use, as determined from FR 19060, May 27, 1986; 53 FR 44009, Nov. 1, 1988] tables 1 and 2 of § 176.170(c) of this chap- ter, yields net chloroform-soluble ex- § 177.1312 Ethylene-carbon monoxide tractives in each extracting solvent copolymers. not to exceed 0.5 milligram per square inch of food-contact surface when test- The ethylene-carbon monoxide co- ed by methods described in § 176.170(d) polymers identified in paragraph (a) of of this chapter. this section may be safely used as com- ponents of articles intended for use in (4) The provisions of this section are contact with food subject to the provi- not applicable to ethylene-carbon mon- sions of this section. oxide copolymers complying with § 175.105 of this chapter. (a) Identity. For the purposes of this section, ethylene-carbon monoxide co- [57 FR 32422, July 22, 1992] polymers (CAS Reg. No. 25052–62–4) con- sist of the basic polymers produced by § 177.1315 Ethylene-1, 4-cyclohexylene the copolymerization of ethylene and dimethylene terephthalate copoly- carbon monoxide such that the copoly- mers. mers contain not more than 30 weight- Ethylene-1, 4-cyclohexylene percent of polymer units derived from dimethylene terephthalate copolymer carbon monoxide. may be safely used as articles or com- (b) Conditions of use. (1) The polymers ponents of articles intended for use in may be safely used as components of contact with food subject to provisions
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of this section and of part 174 of this erized with 1,4-cyclohexanedimethanol chapter. and 1,2-ethanediol) (CAS Reg. No. (a) Identity. For the purposes of this 25038–91–9) are basic copolymers meet- section, ethylene-1,4-cyclohexylene ing the specifications prescribed in dimethylene terephthalate copolymers paragraph (b) of this section, to which (1,4-benzene dicarboxylic acid, di- may have been added certain optional methyl ester, polymerized with 1,4- substances required in their production cyclohexanedimethanol and 1,2- or added to impart desired physical or ethanediol) (CAS Reg. No. 25640–14–6) or technical properties. (1,4-benzenedicarboxylic acid, polym- (b) Specifications:
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 sur- face)
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-con- taining 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 so- lution to that of the solvent, and c=concentration of the test solu- tion expressed in grams per 100 milliliters...... do ...... (2) 0.23 microgram per square ...... do ...... Do. centimeter (1.5 micrograms per square inch) of food-con- tact surface when extracted with 3 percent (by volume) aqueous acetic acid added at 82.2 °C (180 °F) and al- lowed 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-con- tact 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.
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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 sur- face)
...... do ...... (4) 0.16 microgram per square ...... do ...... Do. centimeter (1.0 microgram per square inch) of food-con- tact surface when extracted for 24 hours with 25 percent (by volume) aqueous ethanol at 48.9 °C (120 °F). 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 per- cent cls isomer)...... do ...... (2) 0.23 microgram per square ...... do ...... Do. centimeter (1.5 micrograms per square inch) of food-con- tact surface of oriented co- polymer when extracted with 3 percent (by volume) aque- ous acetic acid added at 87.8 °C (190 °F) and al- lowed 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-con- tact surface of oriented co- polymer 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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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 sur- face)
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- cyclohexanedimethan- ol (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 poly- ethylene 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 per- cent 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 extrac- tives 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 di- luted 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, 200 C St. SW., Washington, DC 20204, and the Amer- The results from a series of extraction ican Society for Testing Materials, 1916 times demonstrate equilibrium when Race St., Philadelphia, PA 19103, re- the net chloroform-soluble extractives spectively, or may be examined at the are unchanging within experimental Office of the Federal Register, 800 error appropriate to the method as de- North Capitol Street, NW., suite 700, scribed in paragraphs (d) (1)(i) and (2)(i) 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 exagger- ated time-temperature test conditions 1. Nonacid (pH above 5.0), aque- Water, n-heptane. compared to the amount extracted by a ous products; may contain salt or sugar or both, and including fat 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 ous products; may contain salt acetic acid. above equations when necessary (See or sugar or both, and including paragraph (e)(6)(ii) of this section for oil-in-water emulsions of low- or method to obtain 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, 200 C St. 176, 177, 178 and § 179.45 of this chapter, SW., Washington, DC 20204, and the Of- it shall also comply with any specifica- fice of the Federal Register, 800 North tions and limitations prescribed for it Capitol St. NW., suite 700, Washington, by that regulation. 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 incor- porated 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, 200 C St. SW., Washington, cobalt–60 sealed source in the dose DC 20204, or may be examined at the range of 5–50 kiloGray (0.5–5.0 Center for Food Safety and Applied Nu- megarads). trition’s Library, 200 C St. SW., rm. (2) The irradiated ethylene-vinyl ace- 3321, Washington, DC, or at the Office tate copolymer films, when extracted of the Federal Register, 800 North Cap- with reagent grade n-heptane (freshly itol St. NW., suite 700, Washington, DC. redistilled before use) according to Compliance of the melt flow index methods described under § 176.170(d)(3) specification shall be determined using of this chapter, at 75 °F for 30 minutes conditions and procedures cor- shall yield total extractives not to ex- responding to those described in the ceed 4.5 percent by weight of the film. method as Condition E, Procedure A). The copolymers shall be used in blends [42 FR 14572, Mar. 15, 1977, as amended at 43 with other polymers at levels not to FR 29287, July 7, 1978; 54 FR 35874, Aug. 30, exceed 17 percent by weight of total 1989; 55 FR 18595, May 3, 1990; 56 FR 42932, Aug. 30, 1991; 64 FR 47108, Aug. 30, 1999] polymer, subject to the limitation that when contacting food of types III, IV– § 177.1360 Ethylene-vinyl acetate-vinyl A, V, VI–C, VII–A, and IX, identified in alcohol copolymers. § 176.170(c) of this chapter, Table 1, the polymers shall be used only under con- Ethylene-vinyl acetate-vinyl alcohol ditions of use C, D, E, F, and G, de- copolymers (CAS Reg. No. 26221–27–2) scribed in § 176.170(c) of this chapter, may be safely used as articles or com- 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 ‘‘Ana- (0.03 milligram per square inch) of lytical 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, 200 C St. SW., only of the types identified in table 1 of Washington, DC 20204, or may be exam- § 176.170(c) of this chapter in Categories ined at the Center for Food Safety and III, IV–A, VII–A, and IX under condi- Applied Nutrition’s Library, 200 C St. tions of use F and G described in table SW., rm. 3321, Washington, DC, or at 2 of § 176.170(c) of this chapter. Film the Office of the Federal Register, 800 samples of 0.0076 centimeter (0.003 inch) North Capitol St. NW., suite 700, Wash- thickness representing the finished ar- ington, 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 limi- tations 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- (ii) Adjuvants used in these layers graphs (c) and (d) of this section) are must comply with an applicable regu- necessary to ensure proper food steri- lation that permits food type and time/ lization and package integrity. Refer temperature conditions to which the to parts 108, 110, 113, and 114 of this container will be exposed, including chapter for details. sterilization processing. (c) Subject to the provisions of this (2) Adhesives. The use of adhesives in paragraph, food-contact articles pro- these containers is optional. Adhesives duced from high-temperature lami- may be formulated from the following nates may be safely used to package all substances, subject to the prescribed food types except those containing limitations: more than 8 percent ethyl alcohol. (i) Any substance suitable for use in (1) Polymeric films/layers. Films or lay- formulating adhesives that complies ers not separated from food by a func- with an applicable regulation of this tional barrier must meet the following chapter which permits food type and requirements: time/temperature conditions to which (i) Films/layers may consist of the the container will be exposed, includ- following: ing sterilization processing. (a) Polyolefin resins complying with (ii) Substances complying with item 2.2 or 3.2 of the table in § 175.105 of this chapter may be used in § 177.1520(c). these constructions, provided they are (b) Polymeric resin blends formu- separated from the interior (food-con- lated from a base polymer complying tact) layer(s) by a functional barrier as with item 2.2 or 3.2 of the table in discussed under paragraph (a) of this § 177.1520(c) blended with no more than section. 10 percent by weight of a copolymer of (iii) Maleic anhydride adduct of poly- ethylene and vinyl acetate complying propylene complying with § 175.300 of with § 177.1350. this chapter. (c) Polymeric resin blends formulated (iv) Polyester-urethane adhesive for from a base polymer complying with use at temperatures not exceeding 121 item 2.2 or 3.2 of the table in °C (250 °F) and formulated from the fol- § 177.1520(c) blended with no more than lowing: 38 percent by weight of a homopolymer (a) Polyester-urethanediol resin pre- of isobutylene complying with pared by the reaction of a mixture of § 177.1420(a)(1). polybasic acids and polyhydric alcohols (d) Polyethylene phthalate resins listed in § 175.300(b)(3)(vii) of this chap- complying with § 177.1630(e)(4) (i) and ter, 3-isocyanatomethyl-3,5,5- (ii). trimethylcyclohexyl isocyanate (CAS (e) Nylon MXD–6 resins that comply Reg. No. 4098–71–9) and optional with item 10.3 of the table in trimethoxysilane coupling agents con- § 177.1500(b) of this chapter when ex- taining amino, epoxy, ether, and/or tracted with water and heptane under mercapto groups not to exceed 3 per- the conditions of time and temperature cent by weight of the cured adhesive. specified for condition of use A, as set (b) Urethane cross-linking agent forth in Table 2 of § 176.170(c) of this comprising not more than 25 percent chapter. by weight of the cured adhesive and (f) Nylon 6⁄12 resins (CAS Reg. No. formulated from 3-isocyanatomethyl- 25191–04–2) complying with item 13.3 of 3,5,5-trimethylcyclohexyl isocyanate the table in § 177.1500(b), for use as (CAS Reg. No. 4098–71–9) adduct of nonfood-contact layers of laminated trimethylol propane (Cas Reg. No. 77– films and in rigid multilaminate con- 99–6) and/or 1,3-bis(isocyanatomethyl) structions with polypropylene outer benzene (CAS Reg. No. 25854–16–4) layers. Laminate structures with au- adduct of trimethylol propane.
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(v) Polyester-epoxy-urethane adhe- scribed in Table I of § 176.170 of this sives formulated from the following: chapter, and formulated from the fol- (a) Polyester resin formed by the re- lowing mixture: action of polybasic acids and (a)(1) Polyesterpolyurethanediol res- polyhydric alcohols listed in ins prepared by the reaction of a mix- § 175.300(b)(3)(vii) of this chapter. Aze- ture of polybasic acids and polyhydric laic acid may also be used as a alcohols listed in § 175.300(b)(3)(vii) of polybasic acid. this chapter and 3-isocyanatomethyl- (b) Epoxy resin listed in 3,5,5-trimethylcyclohexyl isocyanate § 175.300(b)(3)(viii)(a) of this chapter and (CAS Reg. No. 4098–71–9). Additionally, comprising no more than 30 percent by dimethylol propionic acid and 1,6- weight of the cured adhesive. 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), bis(isocyanatomethyl)benzene (CAS (c)(2)(iv), and (c)(2)(vii) of this section Reg. No. 25854–16–4). shall not exceed 0.0016 milligram per (vii) Polyester-polyurethane resin- square centimeter (0.01 milligram per acid dianhydride adhesives for use at square inch) as determined by a meth- temperatures not to exceed 121 °C (250 od entitled ‘‘Determination of Non- °F), in contact only with food Types I, Volatile Chloroform Soluble Residues II, VIA, VIB, VIIB, and VIII as de- in Retort Pouch Water Extracts,’’
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which is incorporated by reference. paragraph (c)(2)(vi) of this section shall Copies are available from the Center not exceed 0.008 milligram per square for Food Safety and Applied Nutrition centimeter (0.05 milligram per square (HFS–200), Food and Drug Administra- inch) as determined by a method enti- tion, 200 C St. SW., Washington, DC tled, ‘‘Determination of Non-volatile 20204, and may be examined at the Cen- Chloroform Soluble Residues in Retort ter for Food Safety and Applied Nutri- Pouch Water Extracts,’’ which is incor- tion’s Library, 200 C St. SW., rm. 3321, porated by reference in paragraph Washington, DC, or at the Office of the (c)(3)(i)(a)(1) of this section. Federal Register, 800 North Capitol St. (ii) Volatiles. Volatile substances em- NW., suite 700, 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 (1) The chloroform-soluble fraction of precoated with a coating complying the total nonvolatile extractives for with § 175.300 of this chapter. containers using no adhesive, or adhe- (2) Nylon 12 resin complying with sives listed in paragraphs (c)(2) (i), (ii), § 177.1500 and having an average thick- and (iii) of this section shall not exceed ness not to exceed 0.0016 inch (41 mi- 0.0020 milligram per square centimeter crons) may be used as the food-contact (0.013 milligram per square inch) as de- surface of the container. termined by a method titled ‘‘Deter- (3) Container test specifications. On mination of Non-volatile Chloroform exposure to distilled water at 250 °F Soluble Residues in Retort Pouch (121 °C) for 2 hours, extractives from Water Extracts,’’ which is incorporated the food-contact side of the nylon 12 by reference. The availability of this multilayered construction shall not ex- incorporation by reference is given in ceed 0.05 milligram per square inch paragraph (c)(3)(i)(a)(1) of this section. (0.0078 milligram per square centi- (2) The chloroform-soluble fraction of meter) as total nonvolatile extractives. the total nonvolatile extractives for containers using adhesives listed in [45 FR 2843, Jan. 15, 1980, as amended at 47 paragraph (c)(2)(v) of this section shall FR 49639, Nov. 2, 1982; 48 FR 236, Jan. 4, 1983; not exceed 0.016 milligram per square 48 FR 15242, Apr. 8, 1983; 48 FR 17347, Apr. 22, 1983; 49 FR 7558, Mar. 1, 1984; 52 FR 33575, centimeter (0.10 milligram per square Sept. 4, 1987; 53 FR 39084, Oct. 5, 1988; 54 FR inch) as determined by a method titled 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996; ‘‘Determination of Non-volatile Chlo- 63 FR 55943, Oct. 20, 1998; 64 FR 4785, Feb. 1, roform Soluble Residues in Retort 1999; 64 FR 46272, Aug. 25, 1999] Pouch Water Extracts,’’ which is incor- porated by reference. The availability § 177.1395 Laminate structures for use of this incorporation by reference is at temperatures between 120 ≥F and ≥ given in paragraph (c)(3)(i)(a)(1) of this 250 F. section. (a) The laminates identified in this (3) The chloroform-soluble fraction of section may be safely used at the speci- the total nonvolatile extractives for fied temperatures. These articles are containers using adhesives listed in layered structures that are optionally
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bonded with adhesives. In these arti- Substances Limitations cles, the food-contact layer does not Nylon 6/66 resins complying For use only with: function as a barrier to migration of with ¤ 177.1500(b), item 4.2 1. Nonalcoholic foods at components from non-food-contact lay- of this chapter (CAS Reg. temperatures not to ex- ers. The layers may be laminated, ex- 24993Ð04Ð2). ceed 82.2 cC (180 cF). Laminate structures with truded, coextruded, or fused. authorized food-contact (b) Laminate structures may be man- materials yield no more ufactured from: than 0.15 milligram of ep- silon-caprolactam per (1) Polymers and adjuvants com- square inch when ex- plying with § 177.1390 of this chapter. tracted with water at 82.2 cC (180 cF) for 5 hours. (2) Any polymeric resin listed in 2. Nonalcoholic foods at these regulations so long as the use of temperatures not to ex- the resin in the structure complies ceed 100 cC (212 cF). Laminate films with au- with the conditions of use (food type thorized food-contact ma- and time/temperature) specified in the terials yield no more than regulation for that resin. 0.15 milligram of epsilon- caprolactam per square (3) Optional adjuvant substances used inch when extracted with in accordance with § 174.5 of this chap- water at 100 cC (212 cF) ter. for 5 hours. Nylon 6/69 resins complying For use with nonalcoholic (4) The following substances in non- with ¤ 177.1500(b), item 14, foods under conditions of food-contact layers only: of this chapter (CAS Reg. use B, C, D, E, F, G, and No. 51995Ð62Ð1). H described in table 2 of Substances Limitations ¤ 176.170 of this chapter. Laminate structures with Ethylene/1,3Ðphenylene oxy- For use only with poly- authorized food-contact ethylene isophthalate/ ethylene terephthalate as materials may contain terephthalate copolymer the food-contact layer, nylon 6/69 resins pro- (CAS Reg. No. 87365Ð98Ð8) complying with vided that the nitrogen complying with ¤ 177.1345. ¤ 177.1630 under condi- content of aqueous ex- tions of use C through G tracts of a representative laminate (obtained at 100 described in table 2 of ° ° ¤ 176.170(c) of this chap- C (212 F) for 8 hours) ter. Laminate structures, does not exceed 15 when extracted with 8 micrograms per square percent ethanol at 150 °F centimeter (100 for 2 hours shall not yield micrograms per square m-pheny lenedioxy-O,O′- inch). diethyl isophthalate or cy- clic bis(ethylene [52 FR 33575, Sept. 4, 1987, as amended at 53 isophthalate) in excess of 7.8 micrograms/square FR 19772, May 31, 1988; 57 FR 43399, Sept. 21, decimeter (0.5 1992; 58 FR 32610, June 11, 1993; 62 FR 53957, microgram/square inch) of Oct. 17, 1997] food-contact surface. Nylon 6/12 resins complying For use with nonalcoholic § 177.1400 Hydroxyethyl cellulose film, with ¤ 177.1500(b), item foods at temperatures not water-insoluble. 13.2, of this chapter (CAS to exceed 100 °C (212 Reg. No. 25191Ð04Ð2). °F). Laminate structures Water-insoluble hydroxyethyl cel- with authorized food-con- lulose film may be safely used for tact materials yield no packaging food in accordance with the more than 0.15 milligram of epsilon-caprolactam following prescribed conditions: and 0.04 milligram of (a) Water-insoluble hydroxyethyl cel- omega-laurolactam per lulose film consists of a base sheet square inch when ex- manufactured by the ethoxylation of tracted with water at 100 °C (212 °F) for 5 hours. cellulose under controlled conditions, to which may be added certain optional substances of a grade of purity suitable for use in food packaging as constitu- ents of the base sheet or as coatings applied to impart desired technological properties. (b) Subject to any limitations pre- 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 regula- tion. § 177.1430 Isobutylene-butene copoly- mers. § 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 deter- mined 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 Colorants used in accord- obtained from the American Society ance with ¤ 178.3297 for Testing Materials, 1916 Race St., of this chapter. Dioctyl phthalate ...... For use as lubricant. Philadelphia, PA 19103, or may be ex- Hexamethylenetetramine For use only as polymerization amined at the Office of the Federal reaction control agent. Register, 800 North Capitol Street, Phthalic acid anhydride .. Do. Zinc stearate ...... For use as lubricant. NW., suite 700, Washington, DC 20408. (iii) Residual acrylonitrile monomer (c) The molded melamine-formalde- content is not more than 11 parts per hyde articles in the finished form in million as determined by gas chroma- which they are to contact food, when tography. extracted with the solvent or solvents (iv) Acetonitrile-soluble fraction characterizing the type of food and after refluxing the base polymer in ace- under the conditions of time and tem- tonitrile for 1 hour is not greater than perature as determined from tables 1 95 percent by weight of the basic co- and 2 of § 175.300(d) of this chapter, polymers. shall yield net chloroform-soluble ex- (2) Extractives limitations. The fol- tractives not to exceed 0.5 milligram lowing extractive limitations are de- per square inch of food-contact surface. termined by an infrared [42 FR 14572, Mar. 15, 1977, as amended at 56 spectrophotometric method titled, ‘‘In- FR 42933, Aug. 30, 1991] frared Spectrophotometric Determina- tion of Polymer Extracted from Borex § 177.1480 Nitrile rubber modified ac- 210 Resin Pellets,’’ which is incor- rylonitrile-methyl acrylate copoly- porated by reference. Copies are avail- mers. able from the Center for Food Safety Nitrile rubber modified acrylonitrile- and Applied Nutrition (HFS–200), Food methyl acrylate copolymers identified and Drug Administration, 200 C St. in this section may be safely used as SW., Washington, DC 20204, or available components of articles intended for for inspection at the Office of the Fed- food-contact use under conditions of eral Register, 800 North Capitol Street, use D, E, F, or G described in table 2 of NW., suite 700, Washington, DC 20408, § 176.170(c) of this chapter, subject to and are applicable to the basic copoly- the provisions of this section. mers in the form of particles of a size (a) For the purpose of this section, that will pass through a U.S. standard nitrile rubber modified acrylonitrile- sieve No. 6 and that will be held on a methyl acrylate copolymers consist of U.S. standard 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)poly- oxyethylene 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 mon- omer 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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(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 –15 when the birefringence disappears in- c 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, 200 C St. SW., Washington, DC through a screen having 1⁄4-inch mesh. 20204, or available for inspection at the Fine particles should be separated from Office of the Federal Register, 800 the cut resin by screening through a 20- North Capitol Street, NW., suite 700, mesh screen. The material retained on 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 con- tents refluxed gently for 8 hours with a [42 FR 14572, Mar. 15, 1977] heating mantle. The solvent is then fil- EDITORIAL NOTE: ForFEDERAL 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. 88526Ð47Ð0), 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, IVÐB, VIÐA through 220 °C (428 °F), and the subsequent catalytic hydrogenation VIÐC, VIIÐB, 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 28Ð67 (Reapproved 1982), food Types III, IVÐA, V, VIIÐA, 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 611Ð82, ‘‘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 (HFSÐ200), Food and Drug Administra- tion, 200 C St. SW., Washington, DC 20204, or may be ex- amined at the Office of the Federal Register, 800 North Cap- itol 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. 78Ð For use as an initiator in the production of propylene 63Ð7). 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 max- imum 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 (HFSÐ 200), Food and Drug Administration, 200 C St. SW., Wash- ington, DC 20204, 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. 121510Ð09Ð6), methyl meth- items 1.1, 3.1a, 3.2a, and 3.2b, where the copolymers com- acrylate/butyl acrylate copolymer (CAS Reg. No. 25852Ð37Ð plying with items 3.1a, 3.2a, and 3.2b contain not less than 3), methyl methacrylate homopolymer (CAS Reg. No. 9011Ð 85 weight-percent of polymer units derived from propylene. 14Ð7), and polypropylene (CAS Reg. No. 9003Ð07Ð0), re- sulting 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 de- termined by a method entitled, ‘‘Determination of the Total Acrylic in PPÐMMA/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 (HFSÐ200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C. St. SW., rm. 3321, Washington, DC, or at the Office of the Fed- eral Register, 800 North Capitol St. NW., suite 700, Wash- ington, DC. Petroleum hydrocarbon resins (cyclopentadiene-type), hydro- For use only as an adjuvant at levels not to exceed 30 percent genated (CAS Reg. No. 68132Ð00Ð3) 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 C4ÐC5 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 28Ð67 (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, IVÐB, VIÐA, VIÐB, VIIÐB, 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 3236Ð88, ‘‘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, IVÐA, V, VIÐC, VIIÐA, 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 (HFSÐ200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or may be examined at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. Polymethylsilsesquioxane (CAS Reg. No. 68554Ð70Ð1) ...... For use only as a surface lubricant or anti-blocking agent in films. Poly(vinylidene fluoride) homopolymer (CAS Reg. No. 24937Ð For use only as a processing aid in the production of olefin 79Ð9), 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 3835Ð79 (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 (HFSÐ200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Wash- ington, DC. Polyoxyethylene-grafted polydimethylsiloxane (CAS Reg. No. For use as an extrusion aid in the production of extruded olefin 68937Ð54Ð2). polymers that comply with ¤ 177.1520(c) at levels not to ex- ceed 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. 122Ð20Ð3) ...... For use as a Zeigler-Natta-type catalyst deactivator and anti- oxidant in the production of olefin polymers complying with ¤ 177.1520(c), items 2.1, 2.2, and 2.3, and having a min- imum density of 0.94 grams per cubic centimeter, and co- polymers complying with ¤ 177.1520(c), items 3.1 and 3.2, for use in contact with all foods under the following condi- tions 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 de- fined 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. 108Ð75Ð8), not less than 60 percent; 2,3,6- 1.3, and propylene copolymers complying with items 3.1, trimethylpyridine (CAS Reg. No. 1462Ð84Ð6), not more than and 3.2 of paragraph (c) of this section provided that the ad- 27 percent; 3,5-dimethylpyridine (CAS Reg. No. 591Ð22Ð0), 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. 9011Ð17Ð0) 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 (HFSÐ200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or may be examined at the Of- fice 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. 9011Ð17Ð0), 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- 3835Ð79 (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 incor- porated 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 (HFSÐ200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.
(c) Specifications:
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)Ð hexane at speci- lene at specified fied temperatures temperatures
1.1a. Polypropylene described in paragraph 0.880Ð0.913 MP: 160°Ð180 °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 0.880Ð0.913Ð MP: 150°Ð180 °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 0.80Ð0.88 only to plasticize polyethylene described under items 2.1 and 2.2 of this table, pro- vided that such plasticized polymers meet the maximum extractable fraction and max- imum soluble fraction specifications pre- scribed for such basic polyethylene
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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)Ð hexane at speci- lene at specified fied temperatures temperatures
1.3. Polypropylene, noncrystalline, for use 0.80Ð0.88 SP:115°Ð138 °C. only: To plasticize polypropylene described by item 1.1 of this table, provided that such plasticized polymers meet the maximum ex- tractable 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, IVÐB, VIÐB, VIIÐB, 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 con- tact food only of the types identified in ¤ 176.170(c) of this chapter, table 1, under Types I, II, IVÐB, VIÐB, VIIÐB, and VIII 2.1. Polyethylene for use in articles that con- 0.85Ð1.00 ...... 5.5 pct at 50 °C 11.3 pct at 25 °C tact food except for articles used for pack- ing or holding food during cooking 2.2. Polyethylene for use in articles used for 0.85Ð1.00 ...... 2.6 pct at 50 °C Do. packing or holding food during cooking 2.3. Polyethylene for use only as component 0.85Ð1.00 ...... 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 mix- ture 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 min- utes as determined by the method de- scribed in paragraph (d)(7) of this section, for use in blends with other polymers at lev- els not to exceed 20 percent by weight of total polymer, subject to the limitation that when contacting food of types III, IVÐA, V, VIÐC, VIIÐA, and IX identified in ¤ 176.170(c) of this chapter, Table 1, the polymers shall be used only under condi- tions 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- 0.85Ð1.00 ...... 5.5 pct at 50 °C 30 pct at 25 °C graph (a)(3)(i) of this section for use in arti- cles 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- 0.9Ð1.00 ...... 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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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)Ð hexane at speci- lene at specified fied temperatures temperatures
3.2a. Olefin copolymers described in para- 0.85Ð1.00 ...... 2.6 pct at 50 °C Do. graph (a)(3)(i) of this section for use in arti- cles 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 copoly- mers described in (a)(3)(i)(a)(2) of this sec- tion 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 con- tact 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 meth- od described in paragraph (d)(7) of this sec- tion, and the thickness of the finished poly- mer contacting food shall not exceed 0.025 mm (0.001 in). Additionally, optional adju- vants 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- 0.85Ð0.92 ...... 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 meth- od described in paragraph (d)(7) of this sec- tion. Articles manufactured using these polymers may be used with all types of food under conditions of use C through H as de- scribed 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 manufac- tured with 1-alkenes having from 6 to 10 carbon atoms 3.3b. Olefin copolymers described in para- graph (a)(3)(ii) of this section, provided that such olefin polymers have a melt tempera- ture 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 min- imum intrinsic viscosity of 1.0 as determined in paragraph (d)(9) of this section.
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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)Ð hexane at speci- lene at specified fied temperatures temperatures
3.4. Olefin copolymers, primarily non-crys- 0.85Ð0.90 talline, described in par. (a)(3) (iii) of this section provided that such olefin polymers have a minimum viscosity average molec- ular weight of 120,000 as determined by the method described in par. (d)(5) of this sec- tion and a minimum Mooney viscosity of 35 as determined by the method described in par. (d)(6) of this section, and further pro- vided 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- 0.85Ð0.90 talline, described in paragraph (a)(3)(iv) of this section, provided that such olefin poly- mers 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 con- tact 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 tem- peratures 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 de- scribed 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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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)Ð hexane at speci- lene at specified fied temperatures temperatures
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 de- termined by the method described in para- graph (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, IVÐB, VI, VII, VIII, and IX. Additionally, optional adjuvants permitted for use in olefin copoly- mers 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 min- utes as determined by the method de- scribed in paragraph (d)(7) of this section, for use in blends with other polymers at lev- els not to exceed 8 percent by weight of total polymer, subject to the limitation that when contacting food of types III, IVÐA, V, VIÐC, VIIÐA, and IX, identified in ¤ 176.170(c) of this chapter, Table 1, the polymers shall be used only under condi- tions 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 iden- tified in ¤ 176.170(c) of this chapter, Table 1 4. Poly(methylpentene) 0.82Ð0.85 MP: 235°Ð250 °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 poly- mers, 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 multi- laminate 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-β- 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 ex- tractives 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 co- meter (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 re- peated-use coatings, 5). The resins shall meet the extrac- based on the tives limitations in paragraph (d) of perfluorocarbon resin identified in paragraph this section. (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 op- tional 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 with a maximum dosage of 7.5 as safe (GRAS) in food or food pack- megarads, to produce lubricant pow- aging subject to any limitations cited ders having a particle diameter of not on their use. more than 20 microns for use only as (2) Substances used in accordance components of articles intended for re- with a prior sanction or approval, sub- peated use in contact with food. ject to any limitations cited in the (d) Specifications—(1) Infrared identi- prior sanction or approval. fication. Perfluorocarbon resins can be (3) Substances authorized under ap- identified by their characteristic infra- plicable regulations in this part and in red spectra. parts 175 and 178 of this chapter and (2) Melt-viscosity. (i) The perfluoro- subject to any limitations prescribed carbon resins identified in paragraph therein. (a)(1) of this section shall have a melt (4) The following substances, subject viscosity of not less than 104 poises at to any limitations prescribed: 380 °C (716 °F) as determined by ASTM
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method D1238–82, ‘‘Standard Test Meth- of 6.45 square decimeters (100 square od for Flow Rates of Thermoplastics by inches) or more and at least 1.27 milli- Extrusion Plastometer,’’ which is in- meters (0.05 inch) thick shall be ex- corporated by reference. Copies may be tracted at reflux temperatures for 2 obtained from the American Society hours separately with distilled water, for Testing Materials, 1916 Race St., 50 percent ethanol, n-heptane, and Philadelphia, PA 19103, or may be ex- ethyl acetate. amined at the Office of the Federal (2) Perfluorocarbon resins identified Register, 800 North Capitol Street, in paragraphs (a)(1) and (2) of this sec- NW., suite 700, Washington, DC 20408. tion and intended for use as coatings or The melt viscosity of the perfluorocarbon resins identified in components of coatings shall meet paragraph (a)(1) of this section shall extractability limits prescribed in not vary more than 50 percent within paragraph (e)(3) of this section when one-half hour at 380 °C (716 °F). the resins in the form of coatings de- (ii) Perfluorocarbon resins identified scribed in paragraphs (e)(2) (i) and (ii) in paragraph (a)(2) of this section shall of this section are extracted at reflux have a melt viscosity of not less than temperatures for 2 hours separately 104 poises at 372 °C (702 °F) as deter- with distilled water, 8 percent ethanol, mined by a more detailed method ti- and n-heptane: tled ‘‘Determination of Melt Viscosity, (i) Perfluorocarbon resin coatings Molecular Weight Distribution Index based on resins identified in paragraph and Viscosity Stability,’’ which is in- (a)(1) of this section shall be applied to corporated by reference. Copies are both sides of a 0.025-millimeter (0.001 available from the Center for Food inch) thick aluminum foil to a thick- Safety and Applied Nutrition (HFS– ness of 0.025 millimeter (0.001 inch) 200), Food and Drug Administration, after thermal curing at 399 °C (750 °F) 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of for 10 minutes. If a primer is used, the the Federal Register, 800 North Capitol total thickness of the primer plus top- Street, NW., suite 700, Washington, DC coat shall equal 0.025 millimeter (0.001 20408. inch) after heat curing. (3) Thermal instability index. The ther- (ii) Perfluorocarbon resin coatings mal instability index of the tetra- based on resins identified in paragraph fluoroethylene homopolymer shall not (a)(2) of this section shall be applied to exceed 50 as determined by ASTM both sides of a 0.025-millimeter (0.001 method D1457–56T, ‘‘Test for Thermal inch) thick aluminum foil to a thick- Instablility index of Tetrafluoro- ness of 0.10 millimeter (0.004 inch) after ethylene Homopolymer’’ (Revised 1956), thermal curing at 427 °C (800 °F) for 10 which is incorporated by reference. minutes. If a primer is used, the total Copies are available from University thickness of the primer plus topcoat Microfilms International, 300 N. Zeeb shall equal 0.10 millimeter (0.004 inch) Rd., Ann Arbor, MI 48106, or available after heat curing. for inspection at the Office of the Fed- (3) The extracted surfaces shall meet eral Register, 800 North Capitol Street, the following extractability limits: NW., suite 700, Washington, DC 20408. (i) Total extractives not to exceed 3.1 The requirements of this paragraph do not apply to polytetrafluoroethylene milligrams per square decimeter (0.2 resin lubricant powders described in milligram per square inch). paragraph (c) of this section. (ii) Fluoride extractives calculated as (e) Limitations. 1 (1) Perfluorocarbon- fluorine not to exceed 0.46 milligram molded articles having a surface area per square decimeter (0.03 milligram per square inch). 1 A more detailed procedure of extraction (f) Conditions of use. Perfluorocarbon conditions is entitled, ‘‘Preparation of Ex- resins identified in paragraph (a)(2) of tracts,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS– inspection at the Office of the Federal Reg- 200), Food and Drug Administration, 200 C St. ister, 800 North Capitol Street, NW., suite SW., Washington, DC 20204, or available for 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 re- use. 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-phenylene- oxy-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 thick- ness 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. 599Ð64Ð4). 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. 115Ð83Ð3). 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. 108Ð polymer when films are extracted for 2 95Ð2). 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 108Ð88Ð3). 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. Provided, That the substances are used (ii) Polycarbonate resins, when ex- in accordance with any limitation on tracted with 50 percent (by volume) concentration, conditions of use, and ethyl alcohol in distilled water at food types specified in § 178.2010(b) of reflux temperature for 6 hours, shall this chapter. yield total extractives not to exceed (c) Polyestercarbonate resins shall 0.15 percent by weight of the resins. conform to the specifications pre- (iii) Polycarbonate resins, when ex- scribed in paragraph (c)(1) of this sec- tracted with n-heptane at reflux tem- tion and shall meet the extractive lim- perature for 6 hours, shall yield total itations prescribed in paragraph (c)(2) extractives not to exceed 0.15 percent of this section. by weight of the resins. (1) Specifications. Polyestercarbonate [42 FR 14572, Mar. 15, 1977, as amended at 46 resins identified in paragraph (a) of FR 23227, Apr. 24, 1981; 49 FR 4372, Feb. 6, this section can be identified by their 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656, characteristic infrared spectrum. The Aug. 8, 1988; 59 FR 43731, Aug. 25, 1994] resins shall comply with either or both of the following specifications: § 177.1585 Polyestercarbonate resins. (i) The solution intrinsic viscosity of Polyestercarbonate resins may be the polyestercarbonate resins shall be safely used as articles or components a minimum of 0.44 deciliter per gram, of articles intended for use in pro- as determined by a method entitled ducing, manufacturing, packing, proc- ‘‘Intrinsic Viscosity (IV) of Lexan essing, preparing, treating, packaging, Polyestercarbonate Resin by a Single or holding food, in accordance with the Point Method Using Dichloromethane following prescribed conditions: as the Solvent,’’ developed by the Gen- (a) Polyestercarbonate resins (CAS eral Electric Co., September 20, 1985, Reg. No. 71519–80–7) are produced by the which is incorporated by reference in condensation of 4,4′- accordance with 5 U.S.C. 552(a) and 1 isopropylidenediphenol, carbonyl chlo- CFR part 51. Copies are available from ride, terephthaloyl chloride, and the Office of Premarket Approval, Cen- isophthaloyl chloride such that the fin- ter for Food Safety and Applied Nutri- ished resins are composed of 45 to 85 tion (HFS–215), Food and Drug Admin- molepercent ester, of which up to 55 istration, 200 C St. SW., Washington, mole-percent is the terephthaloyl iso- DC 20204, or may be examined at the mer. The resins are manufactured Center for Food Safety and Applied Nu- using a phthaloyl chloride/carbonyl trition’s Library, Food and Drug Ad- chloride mole ratio of 0.81 to 5.7/1 and ministration, 200 C St. SW., rm. 3321, isophthaloyl chloride/terephthaloyl Washington, DC, or at the Office of the chloride mole ratio of 0.81/1 or greater. Federal Register, 800 North Capitol St. The resins are also properly identified NW., suite 700, Washington, DC; or
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(ii) A minimum weight-average mo- chapter, table 1, under Type VIII, in ac- lecular weight of 27,000, as determined cordance with the following prescribed by gel permeation chromatography conditions: using polystyrene standards. (a) For the purpose of this section, (2) Extractives limitations. The polyester elastomers are those pro- polyestercarbonate resins to be tested duced by the ester exchange reaction shall be ground or cut into small par- when one or more of the following ticles that will pass through a U.S. phthalates—dimethyl terephthalate, standard sieve No. 6 and that will be dimethyl orthophthalate, and dimethyl held on U.S. standard sieve No. 10. isophthalate—is made to react with (i) Polyestercarbonate resins, when alpha-hydroomega-hydroxypoly extracted with distilled water at reflux (oxytetramethylene) and/or 1,4- temperature for 6 hours, shall yield butanediol such that the finished elas- total nonvolatile extractives not to ex- tomer has a number average molecular ceed 0.005 percent by weight of the res- weight between 20,000 and 30,000. ins. (b) Optional adjuvant substances em- (ii) Polyestercarbonate resins, when ployed in the production of the poly- extracted with 50 percent (by volume) ester elastomers or added thereto to ethyl alcohol in distilled water at impart desired technical or physical reflux temperature for 6 hours, shall properties may include the following yield total nonvolatile extractives not substances: to exceed 0.005 percent by weight of the resins. List of substances Limitations (iii) Polyestercarbonate resins, when 4,4′ - Bis (alpha, alpha-di- For use only as an anti- extracted with n-heptane at reflux methyl-benzyl) oxidant. temperature for 6 hours, shall yield diphenylamine. total nonvolatile extractives not to ex- Tetrabutyl titanate ...... For use only as a catalyst. ceed 0.002 percent by weight of the res- ins. (c) An appropriate sample of the fin- (3) Residual methylene chloride levels in ished polyester elastomer in the form polyestercarbonate resins. Polyester- in which it contacts food when sub- carbonate resin articles in the finished jected to ASTM method D968–81, form shall not contain residual meth- ‘‘Standard Test Methods for Abrasion ylene chloride in excess of 5 parts per Resistance of Organic Coatings by the million as determined by a method ti- Falling Abrasive Tester,’’ which is in- tled ‘‘Analytical Method for Deter- corporated by reference (copies may be mination of Residual Methylene Chlo- obtained from the American Society ride in Polyestercarbonate Resin,’’ de- for Testing Materials, 1916 Race St., veloped by the General Electric Co., Philadelphia, PA 19103, or may be ex- July 23, 1991, which is incorporated by amined at the Office of the Federal reference in accordance with 5 U.S.C. Register, 800 North Capitol Street, 552(a) and 1 CFR part 51. Copies are NW., suite 700, Washington, DC 20408), available from the Center for Food using No. 50 emery abrasive in lieu of Safety and Applied Nutrition (HFS– Ottawa sand, shall exhibit an abrasion 200), Food and Drug Administration, coefficient of not less than 100 liters 200 C St. SW., Washington, DC 20204, or per mil of thickness. may be examined at the Office of the [42 FR 14572, Mar. 15, 1977, as amended at 49 Federal Register, 800 North Capitol FR 10109, Mar. 19, 1984] Street, NW., suite 700, Washington, DC. § 177.1595 Polyetherimide resin. [57 FR 3940, Feb. 3, 1992, as amended at 64 FR 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. of articles intended for use in contact (a) Identity. For the purpose of this with bulk quantities of dry food of the section, the polyetherimide resin is 1,3- type identified in § 176.170(c) of this isobenzofurandione, 5,5′[(1-methyl-
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ethylidene)bis(4,1-phenyleneoxy)] bis- copolymers, containing no more than polymer with 1,3-benzenediamine (CAS 25 weight percent of polymer units de- Reg. No. 61128–46–9), and is derived from rived from methyl acrylate, are made the condensation reaction of m- to react in an aqueous medium with phenylenediamine and bisphenol A- one or more of the following sub- dianhydride. stances: (b) Optional adjuvants. The basic Ammonium hydroxide. polymer identified in paragraph (a) of Calcium carbonate. this section may contain optional adju- Potassium hydroxide. vant substances required in the produc- Sodium hydroxide. tion of basic resins or finished food- (b) The finished food-contact article, contact articles. The optional adjuvant when extracted with the solvent or sol- substances required in the production vents characterizing the type of food of the basic polymer may include sub- and under the conditions of time and stances permitted for such use by ap- temperature characterizing the condi- plicable regulations as set forth in part tions of its intended use as determined 174 of this chapter. from tables 1 and 2 of § 176.170(c) of this (c) Specifications and extractives limi- chapter, yields total extractives in tations—(1) Specifications. each extracting solvent not to exceed Polyetherimide resin identified in 0.5 milligram per square inch of food- paragraph (a) of this section shall have contact surface as determined by the an intrinsic viscosity in chloroform at methods described in § 176.170(d) of this 25 °C (77 °F) of not less than 0.35 deci- chapter; and if the finished food-con- liter per gram as determined by a tact article is itself the subject of a method titled ‘‘Intrinsic Viscosity of regulation in parts 174, 175, 176, 177, 178, ULTEM Polyetherimide Using Chloro- and § 179.45 of this chapter, it shall also form as the Solvent,’’ which is incor- comply with any specifications and porated by reference. Copies are avail- limitations prescribed for it by that able from the Center for Food Safety regulation. In testing the finished food- and Applied Nutrition (HFS–200), Food contact articles, a separate test sample and Drug Administration, 200 C St. is to be used for each required extract- SW., Washington, DC 20204, or available ing solvent. for inspection at the Office of the Fed- (c) The provisions of paragraph (b) of eral Register, 800 North Capitol Street, this section are not applicable to NW., suite 700, Washington, DC 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-con- forming 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 condi- tions prescribed under item 2.1 of the tions: table in § 177.1520(c). Such chlorinated (a) For the purpose of this section, polyethylene contains a maximum of 60 carboxyl-modified polyethylene resins percent by weight of total chlorine, as consist of basic polymers produced determined by ASTM 1method D1303–55 when ethylene-methyl acrylate basic (Reapproved 1979), ‘‘Standard Test
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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 [48 FR 39057, Aug. 29, 1983] 19103, or may be examined at the Office of the Federal Register, 800 North Cap- § 177.1620 Polyethylene, oxidized. itol Street, NW., suite 700, Washington, Oxidized polyethylene identified in DC 20408), and has a 7.0 percent max- paragraph (a) of this section may be imum extractable fraction in n-hexane safely used as a component of food-con- at 50 °C, as determined by the method tact articles, in accordance with the described in § 177.1520(d)(3)(ii). (b) Chlorinated polyethylene may be following prescribed conditions: (a) Oxidized polyethylene is the basic used in contact with all types of food, resin produced by the mild air oxida- except that when used in contact with tion of polyethylene conforming to the fatty food of Types III, IV–A, V, VII–A, density, maximum n-hexane extract- and IX described in table 1 of § 176.170(c) able fraction, and maximum xylene of this chapter, chlorinated poly- soluble fraction specifications pre- ethylene is limited to use only as a scribed under item 2.3 of the table in modifier admixed at levels not exceed- § 177.1520(c). Such oxidized polyethylene ing 15 weight percent in plastic articles has a minimum number average molec- prepared from polyvinyl chloride and/ ular weight of 1,200, as determined by or from vinyl chloride copolymers com- high temperature vapor pressure os- plying with § 177.1980. mometry, contains a maximum of 5 [42 FR 14572, Mar. 15, 1977, as amended at 49 percent by weight of total oxygen, and FR 10109, Mar. 19, 1984; 59 FR 14550, Mar. 29, has an acid value of 9 to 19. 1994] (b) The finished food-contact article, when extracted with the solvent or sol- § 177.1615 Polyethylene, fluorinated. vents characterizing the type of food Fluorinated polyethylene, identified and under the conditions of time and in paragraph (a) of this section, may be temperature characterizing the condi- safely used as food-contact articles in tions of its intended use as determined accordance with the following pre- from tables 1 and 2 of § 176.170(c) of this scribed conditions: chapter, yields net acidified chloro- (a) Fluorinated polyethylene food- form-soluble extractives not to exceed contact articles are produced by modi- 0.5 milligram per square inch of food- fying the surface of polyethylene arti- contact surface when tested by the cles through action of fluorine gas in methods described in § 177.1330(c), ex- combination with gaseous nitrogen as cept that net acidified chloroform-solu- an inert diluent. Such modification af- ble extractives from paper and paper- fects only the surface of the polymer, board complying with § 176.170 of this leaving the interior unchanged. chapter may be corrected for wax, pet- Fluorinated polyethylene articles are rolatum, and mineral oil as provided in manufactured from basic resins con- § 176.170(d) (5)(iii)(b) of this chapter. If taining not less than 85 weight-percent the finished food-contact article is of polymer units derived from ethylene itself the subject of a regulation in and identified in § 177.1520 (a)(2) and parts 174, 175, 176, 177, 178 and § 179.45 of (3)(i). this chapter, it shall also comply with (b) Fluorinated polyethylene articles any specifications and limitations pre- conform to the specifications and use scribed for it by such regulations. limitations of § 177.1520(c), items 2.1 and (NOTE: In testing the finished food-con- 3.1. tact article, use a separate test sample (c) The finished food-contact article, for each extracting solvent.) when extracted with the solvent or sol- (c) The provisions of this section are vents characterizing the type of food not applicable to oxidized polyethylene and under conditions of time and tem- used as provided in §§ 175.105 and 176.210 perature characterizing the conditions of this chapter, and § 177.2800. The pro- of its intended use as determined from visions of paragraph (b) of this section
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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 (3) Substances which by regulation in dimethylene terephthalate copoly- parts 174, 175, 176, 177, 178 and § 179.45 of esters described in § 177.1315(b)(3), to this chapter may be safely used as which have been added optional sub- components of resinous or polymeric stances, either as constituents of the food-contact surfaces subject to the base sheet or as constituents of coat- provisions of such regulation. ings applied to the base sheet. (4) Substances identified in this para- (b) Polyethylene phthalate articles graph (e)(4) subject to the limitations consist of a base polymer of ethylene prescribed: terephthalate polymer, or ethylene-1,4- LIST OF SUBSTANCES AND LIMITATIONS cyclohexylene dimethylene terephthalate copolyesters described in (i) Base sheet: § 177.1315(b)(3), to which have been Ethylene terephthalate copolymers: Pre- added optional substances, either as pared by the condensation of dimethyl constituents of the base polymer or as terephthalate or terephthalic acid with constituents of coatings applied to the ethylene glycol, modified with one or more of the following: Azelaic acid, dimethyl base polymer. azelate, dimethyl sebacate, sebacic acid. (c)(1) Polyethylene phthalate Ethylene terephthalate copolymers: Pre- spunbonded nonwoven fabric consist of pared by the condensation of dimethyl continuous filaments of ethylene terephthalate or terephthalic acid with terephthalate polymer and ethylene ethylene glycol, modified with one or more terephthalate-isophthalate copolymer of the following: Azelaic acid, dimethyl to which may have been added optional azelate, dimethyl sebacate, sebacic acid, adjuvant substances required in their pyromellitic dianhydride. The level of pyromellitic dianhydride shall not exceed preparation and finishing. 0.5 percent by weight of the finished co- (2) The ethylene terephthalate- polymer which may be used under condi- isophthalate copolymer component of tions of use E through H as described in the fabric shall not exceed 25 percent table 2 of § 176.170(c) of this chapter. by weight. The filaments may be blend- Ethylene terephthalate-isophthalate copoly- ed with other fibers regulated for the mers: Prepared by the condensation of di- specific use and the spunbonded fabric methyl terephthalate or terephthalic acid may be further bonded by application and dimethyl isophthalate or isophthalic acid with ethylene glycol. The finished co- of heat and/or pressure. polymers contain either: (3) The fabric shall be used only in (a) 77 to 83 weight percent or accordance with paragraph (i) of this (b) At least 97 weight percent of polymer section. units derived from ethylene (d) The quantity of any optional sub- terephthalate. stance employed in the production of (ii) Base sheet and base polymer: polyethylene phthalate plastics does Ethylene-1,4-cyclohexylene dimethylene not exceed the amount reasonably re- terephthalate copolyesters described in quired to accomplish the intended § 177.1315(b)(3).
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Ethylene terephthalate polymer: Prepared plying with paragraph (a) of this section, by the condensation of dimethyl at levels not to exceed 0.025 gram per terephthalate and ethylene glycol. square meter (0.016 milligram per square Ethylene terephthalate polymer: Prepared inch) of the film, in contact with food of by the condensation of terephthalic acid types VIII and IX in table 1 of § 176.170(c) of and ethylene glycol. this chapter, under use conditions E, F, and G in table 2 of § 176.170(c) of this chap- (iii) Coatings: ter. Acrylic copolymers (CAS Reg. No. 30394–86– 6): Prepared by reaction of ethyl acrylate (iv) Emulsifiers: (CAS Reg. No. 140–88–5), methyl methacry- Sodium dodecylbenzenesulfonate: As an ad- late (CAS Reg. No. 80–62–6), and juvant in the application of coatings to the methacrylamide (CAS Reg. No. 79–39–0) base sheet or base polymer. blended with melamine-formaldehyde resin Sodium lauryl sulfate: As an adjuvant in the (CAS Reg. No. 68002–20–0). For use in coat- application of coatings to the base sheet or ings for polyethylene phthalate films com- base polymer. plying with paragraph (a) of this section.– 2-Sulfoethyl methacrylate, sodium salt (CAS Ethylene azelate-terephthalate copolymer: Reg. No. 1804–87–1). For use only in copoly- The copolymer, dissolved in 1,1,2-trichloro- mer coatings on polyethylene phthalate ethane and/or methylene chloride, may be film under conditions of use E, F, and G de- used as a heat-activated sealant on poly- scribed in table 2 of § 175.300(d) of this chap- ethylene terephthalate film intended for ter, and limited to use at a level not to ex- sealing polyethylene terephthalate pouch- ceed 2.0 percent by weight of the dry co- es that are used as containers of either polymer coating. nonalcoholic beverages or alcoholic bev- erages containing not more than 15 percent (v) Modifier: ethyl alcohol. The copolymer has a 1,4-Benzenedicarboxylic acid, dimethyl ester, terephthalate/azelate molecular ratio of polymer with 1,4-butanediol and α-hydro- 1.25/1.00 and a relative viscosity of not less omega-hydroxypoly(oxy-1,4-butanediyl) than 1.5 as determined by a method title CAS Reg. No. 9078–71–1) meeting the fol- ‘‘General Procedure of Determining the lowing specifications: Relative Viscosity of Resin Polymers,’’ Melting point: 200° to 215 °C as determined which is incorporated by reference. Copies by ASTM method D2117–82, ‘‘Standard are available from the Center for Food Test Method for Melting Point of Safety and Applied Nutrition (HFS–200), Semicrystalline Polymers by the Hot Food and Drug Administration, 200 C St. Stage Microscopy Method,’’ which is in- SW., Washington, DC 20204, or available for corporated by reference. Copies may be inspection, at the Office of the Federal obtained from the American Society for Register, 800 North Capitol Street, NW., Testing Materials, 1916 Race St., Phila- suite 700, Washington, DC 20408. Total re- delphia, PA 19103, or may be examined at sidual copolymer solvent (1,1,2-trichloro- the Office of the Federal Register, 800 ethane and/or methylene chloride) shall North Capitol Street, NW., suite 700, not exceed 0.13 milligram per square inch Washington, DC 20408. of film, and food contact of the film shall Density: 1.15 to 1.20 as determined by ASTM be limited to not more than 1 square inch method D1505–68 (Reapproved 1979), per 250 grams of beverage. ‘‘Standard Test Method for Density of 2-Ethylhexyl acrylate copolymerized with Plastics by the Density-Gradient Tech- one or more of the following: nique,’’ which is incorporated by ref- Acrylonitrile. erence. Copies may be obtained from the Methacrylonitrile. American Society for Testing Materials, Methyl acrylate. 1916 Race St., Philadelphia, PA 19103, or Methyl methacrylate. may be examined at the Office of the Itaconic acid. Federal Register, 800 North Capitol Vinylidene chloride copolymerized with one Street, NW., suite 700, Washington, DC or more of the following: 20408. Methacrylic acid and its methyl, ethyl, The modifier is used at a level not to ex- propyl, butyl, or octyl esters. ceed 5 percent by weight of polyethylene Acrylic acid and its methyl, ethyl, propyl, terephthalate film. The average thick- butyl, or octyl esters. ness of the finished film shall not exceed Acrylonitrile. 0.016 millimeter (0.0006 inch). Methacrylonitrile. Hexanedioic acid polymer with 1,3- Vinyl chloride. benzenedimethanamine (CAS Reg. No. Itaconic acid. 25718–70–1) meeting the specifications in Styrene-maleic anhydride resin, partial 2- § 177.1500(b), item 10, when tested by the butoxyethyl ester, ammonium salt (CAS methods given in § 177.1500(c). The modi- Reg. No. 68890–80–2). For use only as a coat- fier is used in polyethylene terephthalate ing for polyethylene phthalate films com- at a level not to exceed 30 percent by
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weight of the polyethylene from substances identified in para- terephthalate. graphs (e)(4)(i) and (ii) of this section Chloroform-soluble extractives shall not and conforming with the specifications exceed 0.08 milligram/centimeter 2 (0.5 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 except (a) those containing more than 8 (ii) The food contact surface, when percent alcohol, or (b) those at tempera- exposed to n-heptane at 150 °F for 2 tures over 49 °C (120 °F). hours, yields chloroform-soluble ex- (f) Polyethylene phthalate plastics tractives not to exceed 0.02 milligram/ 2 conforming with the specifications pre- inch of food contact surface exposed scribed in paragraph (f)(1) of this sec- to the solvent. tion are used as provided in paragraph (2) Conditions of use. The plastics are (f)(2) of this section: used to contain foods during oven bak- (1) Specifications. (i) The food contact ing or oven cooking at temperatures surface, when exposed to distilled above 250 °F. water at 250 °F for 2 hours, yields chlo- (i) Polyethylene phthalate fabric, roform-soluble extractives not to ex- identified in paragraph (c) of this sec- ceed 0.5 mg/in 2 of food contact surface tion and conforming with the specifica- exposed to the solvent; and tions prescribed in paragraph (i)(1) of (ii) The food contact surface, when this section, is used only as provided in exposed to n-heptane at 150 °F for 2 paragraph (i)(2) of this section. hours, yields chloroform-soluble ex- (1) Specifications. Chloroform-soluble 2 tractives not to exceed 0.5 mg/in of extractives shall not exceed 0.2 milli- food contact surface exposed to the sol- gram/inch 2 of food-contact surface vent. when exposed to the following solvents (2) Conditions of use. The plastics are at temperatures and times indicated: used for packaging, transporting, or ° holding food, excluding alcoholic bev- (i) Distilled water at 212 F for 2 erages, at temperatures not to exceed hours. 250 °F. (ii) n-Heptane at 150 °F for 2 hours. (g) Polyethylene phthalate plastics (iii) 50 percent ethyl alcohol at 120 °F conforming with the specifications pre- for 24 hours. scribed in paragraph (g)(1) of this sec- (2) Conditions of use. The plastics are tion are used as provided in paragraph intended for: (g)(2) of this section. (i) Dry food contact. (1) Specifications. (i) The food contact (ii) Bulk food (excluding alcoholic surface meets the specifications in beverages) repeated use applications, paragraph (f)(1) of this section; and including filtration, at temperatures (ii) The food contact surface when ex- not exceeding 212 °F. posed to 50 percent ethyl alcohol at 120 (iii) Filtration of bulk alcoholic bev- °F for 24 hours, yields chloroform-solu- erages, not exceeding 50 percent alco- ble extractives not to exceed 0.5 mg/in 2 of food contact surface exposed to the hol by volume, at temperatures not ex- ° solvent. ceeding 120 F. (2) Conditions of use. The plastics are (j) Polyethylene phthalate plastics, used for packaging, transporting, or composed of ethylene terephthalate- holding alcoholic beverages that do not isophthalate containing a minimum of exceed 50 percent alcohol by volume. 98 weight percent of polymer units de- (h) Uncoated polyethylene phthalate rived from ethylene terephthalate, or plastics consisting of a base sheet or ethylene-1,4-cyclohexylene base polymer prepared as prescribed
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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. 3648Ð20Ð2). Mono- and dipotassium salts mL capacity. The food-contact surface of lauryl phosphate (CAS when exposed to 95 percent ethanol at Reg. No. 39322Ð78Ð6). 120 °F for 24 hours should not yield o-Phenylphenol (CAS Reg. For use as a fungicide for fin- No. 90Ð43Ð7). 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. 500 mL capacity. The food contact sur- Poly(oxyethylene/ oxypropylen- face when exposed to 95 percent eth- e)monobutylether (CAS anol at 120 °F for 24 hours should not Reg. No. 9038Ð95Ð3). yield chloroform-soluble extractives in Poly(oxyethylene) 2 mono(nonylphenyl)ether excess of 0.05 mg/in . (CAS Reg. No. 9019Ð45Ð (2) Conditions of use. The plastics are 9). used for packaging, transporting, or Polyvinyl methylether (CAS Reg. No. 9003Ð09Ð2). holding alcoholic foods that do not ex- Poly(oxyethylene) sorbitol ceed 95 percent alcohol by volume. monolaurate tetraoleate (CAS Reg. No. 71243Ð28Ð [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 57171Ð56Ð9). ′ 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. 85Ð60Ð9). 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) res- in 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 (b) Optional adjuvant substances. The yarns and fibers may be used as compo- poly(phenyleneterephthalamide) resins nents of articles intended for repeated identified in paragraph (a) of this sec- use in contact with food at tempera- tion may contain the following op- tures not to exceed 260 °C (500 °F). All tional adjuvant substances, subject to items are scoured prior to use by agita- any limitation on their use: tion in a water bath containing 0.5
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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. tled, ‘‘Gas Chromatographic Deter- (2) Poly(phenyleneterephthalamide) mination of PMS and PET in PPMS resins in the form of pulp may be used Basic Polymers,’’ which is incorporated as gaskets and packing for food proc- by reference. Copies are available from essing equipment at temperatures not the Center for Food Safety and Applied to exceed 260 °C (500 °F). Nutrition (HFS–200), Food and Drug [57 FR 3125, Jan. 28, 1992] Administration, 200 C St. SW., Wash- ington, DC 20204, or available for in- § 177.1635 Poly(p-methylstyrene) and spection at the Office of the Federal rubber-modified poly(p-methyl- Register, 800 North Capitol Street, styrene). NW., suite 700, Washington, DC 20408. Poly(p-methylstyrene) and rubber- (2) Rubber-modified poly(p- modified poly(p-methylstyrene) identi- methylstyrene) basic polymers identi- fied in this section may be safely used fied in paragraph (a)(2) of this section as components of articles intended for shall contain not more than 0.5 weight use in contact with food, subject to the percent of total residual p- provisions of this section: methylstyrene monomer, as deter- (a) Identity. For the purposes of this mined by the method identified in section, poly(p-methylstyrene) and paragraph (c)(1) of this section rubber-modified poly(p-methylstyrene) (d) Other specifications and limitations. are basic polymers, manufactured as The poly(p-methylstyrene) and rubber- described in this paragraph, meeting modified poly(p-methylstyrene) identi- the specifications prescribed in para- fied in and complying with this sec- graph (c) of this section. tion, when used as components of the (1) Poly(p-methylstyrene) (CAS Reg. food-contact surface of any article that No. 24936–41–2) polymer produced by the is the subject of a regulation in parts polymerization of p-methylstyrene. 175, 176, 177, 178 and § 179.45 of this chap- (2) Rubber-modified poly(p- ter, shall comply with any specifica- methylstyrene) (CAS Reg. No. 33520–88– tions and limitations prescribed by 6) polymer produced by combining sty- such regulation for the article in the rene-butadiene copolymer and/or finished form in which it is to contact polybutadiene with poly(p- food. methylstyrene), either during or after (e) Conditions of use. Poly(p- polymerization of the poly(p- methylstyrene) basic polymers and methylstyrene), such that the finished rubber-modified poly(p-methylstyrene) polymers contain not less than 75 basic polymers identified in paragraphs weight percent of total polymer units (a)(1) and (a)(2), respectively, of this derived from p-methylstyrene) mon- section shall be used in contact with omer. food only under conditions of use B (b) Optional adjuvants. The basic through H set forth in table 2 of polymers identified in paragraph (a) of § 176.170(c) of this chapter. this section may contain optional adju- [48 FR 31384, July 8, 1983, as amended at 54 vant substances required in the produc- FR 24898, June 12, 1989; 55 FR 52989, Dec. 26, tion of such basic polymers. Such op- 1990] tional adjuvant substances may in- clude substances permitted for such § 177.1637 Poly(oxy-1,2- use by applicable regulations in this ethanediyloxycarbonyl-2,6- chapter, substances generally recog- naphthalenediylcarbonyl) resins. nized as safe in food, substances gen- Poly(oxy-1,2-ethanediyloxycarbonyl- erally recognized as safe in indirect ad- 2,6-naphthalenediylcarbonyl) resins ditives, and substances used in accord- identified in paragraph (a) of this sec- ance with prior sanction or approval. tion may be safely used as articles or (c) Specifications. (1) Poly(p- components of articles intended for use methylstyrene) basic polymers identi- in contact with food in accordance fied in paragraph (a)(1) of this section with the following conditions:
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(a) Identity. For the purpose of this table 2 of § 176.170(c) of this chapter; section, poly(oxy-1,2- and ethanediyloxycarbonyl-2,6- (2) Identified in a manner that will naphthalenediylcarbonyl) resins (CAS differentiate the article from articles Reg. No. 24968–11–4) are polymers made of other polymeric resins to fa- formed by catalytic transesterification cilitate collection and sorting. of 2,6-dimethylnaphthalene [61 FR 14965, Apr. 4, 1996] dicarboxylate with ethylene glycol fol- lowed by catalytic polycondensation. § 177.1640 Polystyrene and rubber- (b) Specifications—(1) Density. The modified polystyrene. density of poly(oxy-1,2- Polystyrene and rubber-modified pol- ethanediyloxycarbonyl-2,6- ystyrene identified in this section may naphthalenediylcarbonyl) resins shall be safely used as components of arti- be between 1.33 and 1.40 grams per cles intended for use in contact with cubic centimeter. food, subject to the provisions of this (2) Inherent viscosity. The finished section. food-contact article shall have a min- (a) Identity. For the purposes of this imum inherent viscosity of 0.55 deci- section, polystyrene and rubber-modi- liter per gram in a solution of 0.1 gram fied polystyrene are basic polymers of polymer in 100 milliliters of a 25/40/ manufactured as described in this para- 35 (weight/weight/weight) solution of p- graph so as to meet the specifications chlorophenol/tetrachloroethane/phenol. prescribed in paragraph (c) of this sec- The viscosity is determined by East- tion when tested by the method de- man Chemical Co.’s method ECD-A-AC- scribed in paragraph (d) of this section. G-V-1-5, ‘‘Determination of Dilute So- (1) Polystyrene consists of basic poly- lution Viscosity of Polyesters,’’ dated mers produced by the polymerization May 31, 1988, which is incorporated by of styrene. reference in accordance with 5 U.S.C. (2) Rubber-modified polystyrene con- 552(a) and 1 CFR part 51. Copies are sists of basic polymers produced by available from the Office of Premarket combining styrene-butadiene copoly- Approval, Center for Food Safety and mers and/or polybutadiene with poly- Applied Nutrition (HFS–215), Food and styrene, either during or after polym- Drug Administration, 200 C St. SW., erization of the polystyrene, such that Washington, DC 20204, or may be exam- the finished basic polymers contain not ined at the Center for Food Safety and less than 75 weight percent of total Applied Nutrition’s Library, Food and polymer units derived from styrene Drug Administration, 200 C St. SW., monomer. rm. 3321, Washington, DC, or at the Of- (b) Optional adjuvants. The basic fice of the Federal Register, 800 North polymers identified in paragraph (a) of Capitol St. 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 (d) Conditions of use. The finished substances used in accordance with a food contact article shall be: prior sanction or approval. (1) Used in contact only with food of (c) Specifications. (1) Polystyrene Types I, II, IVB, VIA, VIB, VIIB, and basic polymers identified in paragraph VIII identified in table 1 of § 176.170(c) (a)(1) of this section shall contain not of this chapter, under conditions of use more than 1 weight percent of total re- A through H described in table 2 of sidual styrene monomer, as determined § 176.170(c) of this chapter; and with by the method described in paragraph food of Types III, IVA, V, VIC, VIIA, (d) of this section, except that when and IX identified in table 1 of used in contact with fatty foods of § 176.170(c) of this chapter, under condi- Types III, IV-A, V, VII-A, and IX de- tions of use C through H described in scribed in table 1 of § 176.170(c) of this
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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 supernatant layer appears. (2) Principle. The sample is dissolved (ii) By means of a microliter syringe, in methylene chloride. An aliquot of inject 3 microliters of the clear super- the solution is injected into a gas chro- natant liquid into the gas chro- matograph. The amount of styrene matograph. monomer present is determined from (iii) Measure the area of the resulting the area of the resulting peak. styrene monomer peak. Compare the (3) Apparatus—(i) Gas chromatograph. sample peak area with the area pro- Beckman GC-2A gas chromatograph duced by the standard styrene mon- with hydrogen flame detector or appa- omer solution. Calculation: ratus of equivalent sensitivity. (ii) Chromatograph column. One-quar- Percent residual styrene monomer=Milligrams monomer in stand- ter inch outside diameter stainless ard×peak area of sample/Peak area of mon- steel tubing (0.028 inch wall thickness), omer standard×sample weight in grams×30 4 feet in length, packed with 20 percent polyethylene glycol (20,000 molecular (e) Other specifications and limitations. weight) on alkaline treated 60–80 mesh The polystyrene and rubber-modified firebrick. polystyrene identified in and com- (iii) Recorder. Millivolt range of 0–1, plying with this section, when used as components of the food-contact surface chart speed of 30 inches per hour. of any article that is the subject of a (4) Reagents. Compressed air, purified; regulation in parts 174, 175, 176, 177, 178 helium gas; hydrogen gas; methylene and § 179.45 of this chapter, shall com- chloride, redistilled; and styrene mon- ply with any specifications and limita- omer, redistilled. tions prescribed by such regulation for (5) Operating conditions for the gas the article in the finished form in chromatograph. (i) The column is oper- which it is to contact food. ° ated at a temperature of 100 C with a (f) Nonapplicability. The provisions of helium flow rate of 82 milliliters per this section are not applicable to poly- minute. styrene and rubber-modified poly- (ii) The hydrogen burner is operated styrene used in food-packaging adhe- with 15 pounds per square inch of air sives complying with § 175.105 of this pressure and 7 pounds per square inch chapter. of hydrogen pressure. (iii) The attenuation of the hydrogen § 177.1650 Polysulfide polymer- flame detector is set at 2×102. polyepoxy resins. (6) Standardization. (i) Prepare a Polysulfide polymer-polyepoxy res- standard solution by weighing accu- ins may be safely used as the food-con- rately 15 to 20 milligrams of styrene tact surface of articles intended for monomer into a 2-ounce bottle con- packaging, transporting, holding, or taining 25.0 milliliters of methylene otherwise contacting dry food, in ac- chloride. Cap the bottle tightly and cordance with the following prescribed shake to thoroughly mix the solution. conditions:
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(a) Polysulfide polymer-polyepoxy itol Street, NW., suite 700, Washington, resins are the reaction products of liq- DC 20408), using No. 50 Emery abrasive uid polysulfide polymers and in lieu of Ottawa sand, shall exhibit polyfunctional epoxide resins, cured and abrasion coefficient of not less with the aid of than 20 liters per mil of film thickness. tri(dimethylaminomethyl) phenol, to which have been added certain optional [42 FR 14572, Mar. 15, 1977, as amended at 49 substances to impart desired techno- FR 10110, Mar. 19, 1984] logical properties to the resins. Subject to any limitations prescribed in this § 177.1655 Polysulfone resins. section, the optional substances may Polysulfone resins identified in para- include: graph (a) of this section may be safely (1) Substances generally recognized used as articles or components of arti- as safe in food and food packaging. cles intended for use in contact with (2) Substances the use of which is food, in accordance with the following permitted under applicable regulations prescribed conditions: in this part, prior sanctions, or approv- (a) For the purpose of this section, als. polysulfone resins are: (3) Substances named in this subpara- (1) Poly(oxy-p-phenylenesulfonyl-p- graph and further identified as re- phenyleneoxy-p- quired: phenyleneisopropylidene-p-phenylene) List of substances Limitations resins (CAS Reg. No. 25154–01–2) con- sisting of basic resins produced when Bis(2-chloroethyl) formal. Bis(dichloropropyl) formal ...... Cross-linking agent. the disodium salt of 4,4′- Butyl alcohol ...... Solvent. isopropylidenediphenol is made to Carbon black (channel process). react with 4,4′-dichlorodiphenyl sulfone Chlorinated paraffins ...... Cross-linking agent. Epoxidized linseed oil. in such a way that the finished resins Epoxidized soybean oil. have a minimum number average mo- Epoxy resins (as listed in ¤ 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. monochlorobenzene; or Magnesium chloride. ′ Methyl isobutyl ketone ...... Solvent. (2) 1,1 -Sulfonylbis[4-chlorobenzene] Naphthalene sulfonic acid-formalde- polymer with 4,4′-(1- hyde condensate, sodium salt. methylethylidene)bis[phenol] (min- Sodium dibutyl naphthalene Wetting agent. sulfonate. imum 92 percent) and 4,4′- Sodium hydrosulfide. sulfonylbis[phenol] (maximum 8 per- Sodium polysulfide. cent) (CAS Reg. No. 88285–91–0) pro- β,β′,γ,γ′-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 Xylene ...... Solvent. such a way that the finished resin has (b) The resins are used as the food- a minimum number average molecular contact surface for dry food. weight of 26,000, as determined by os- (c) An appropriate sample of the fin- motic pressure in dimethylformamide. ished resin in the form in which it con- (b) The basic polysulfone resins iden- tacts food, when subjected to ASTM tified in paragraph (a) of this section method D968–81, ‘‘Standard Test Meth- may contain optional adjuvant sub- ods for Abrasion Resistance of Organic stances required in the production of Coatings by the Falling Abrasive Test- such basic resins. The optional adju- er,’’ which is incorporated by reference vant substances required in the produc- (copies may be obtained from the tion of the basic polysulfone resins American Society for Testing Mate- may include substances described in rials, 1916 Race St., Philadelphia, PA § 174.5(d) of this chapter and the fol- 19103, or may be examined at the Office lowing: of the Federal Register, 800 North Cap-
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List of substances Limitations tion may contain optional adjuvant substances. The quantity of any op- Dimethyl sulfoxide ..... Not to exceed 50 parts per million as 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. exceed the amount reasonably required Monochlorobenzene .. Not to exceed 500 parts per million to accomplish the intended technical as residual solvent in finished 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 nized as safe in food, substances used in pyrrolidone. parts per million) as residual sol- 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 peated use in contact with food may be grams 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 when extracted for 2 hours at 250 °F [51 FR 882, Jan. 9, 1986; 51 FR 4165, Feb. 3, 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. articles or components of articles in- (iv) Not to exceed 0.02 milligram per tended to contact food, in accordance square inch of food contact surface ° with the following prescribed condi- when extracted for 2 hours at 65.6 C ° tions: (150 F) with 50 percent ethanol. (a) Identity. For the purpose of this [42 FR 14572, Mar. 15, 1977, as amended at 50 section, poly (tetramethylene FR 20748, May 20, 1985; 52 FR 20069, May 29, terephthalate) is the reaction product 1987] of dimethyl terephthalate with 1,4- butanediol to which may have been § 177.1670 Polyvinyl alcohol film. added certain optional substances to Polyvinyl alcohol film may be safely impart desired technological properties used in contact with food of the types to the polymer. identified in § 176.170(c) of this chapter, (b) Optional adjuvant substances. table 1, under Types V, VIII, and IX, in Poly(tetramethylene terephthalate) accordance with the following pre- identified in paragraph (a) of this sec- scribed conditions:
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(a) The polyvinyl alcohol film is pro- 4,4′-Diisocyanato-3,3′-dimethylbiphenyl (bi- duced from polyvinyl alcohol having a tolylene diisocyanate). minimum viscosity of 4 centipoises Diphenylmethane diisocyanate. when a 4-percent aqueous solution is Hexamethylene diisocyanate. ° 3-Isocyanatomethyl - 3,5,5 - trimethylcyclo- tested at 20 C. hexyl isocyanate. (b) The finished food-contact film for 4,4-Methylenebis(cyclohexyl isocyanate). use in contact with Food Types V or Toluene diisocyanate. IX, when extracted with the solvent (2) List of substances: characterizing the type of food and under the conditions of time and tem- Adipic acid. perature characterizing its intended 1,4-Butanediol. use as determined from tables 1 and 2 1,3-Butylene glycol. of § 176.170(c) of this chapter, yields 1,4–Cyclohexane dimethanol (CAS Reg. No. 105–08–8). total extractives not to exceed 0.078 2,2-Dimethyl-1,3-propanediol. milligram per square centimeter (0.5 Ethylene glycol. milligram per square inch) of food-con- 1,6–Hexanediol (CAS Reg. No. 629–11–8).α– tact surface when tested by ASTM Hydro–οµεγα–hydroxypoly(oxy–1,4– method F34–76 (Reapproved 1980), butanediyl) (CAS Reg. No. 25190–06–1). ‘‘Standard Test Method for Liquid Ex- α-Hydro-omega-hydroxypoly (oxytetra- traction of Flexible Barrier Materials,’’ methylene). α α′ which is incorporated by reference. , -(Isopropylidenedi-p-phenylene)bis[omega- hydroxypoly (oxypropylene)(3–4 moles)], Copies may be obtained from the Amer- average molecular weight 675. ican Society for Testing Materials, 1916 Maleic anhydride. Race St., Philadelphia, PA 19103, or Methyl oxirane polymer with oxirane (CAS may be examined at the Office of the Reg. No. 9003–11–6). Federal Register, 800 North Capitol Methyl oxirane polymer with oxirane, ether Street, NW., suite 700, Washington, DC with 1,2,3–propanetriol (CAS Reg. No. 9082– 20408. 00–2). α,α′α″,α′″-Neopentanetetrayltetrakis [omega- (c) The finished food-contact film hydroxypoly (oxypropylene) (1–2 moles)], shall not be used as a component of average molecular weight 400. food containers intended for use in con- Pentaerythritol-linseed oil alcoholysis prod- tact with water. uct. Phthalic anhydride. [42 FR 14572, Mar. 15, 1977, as amended at 49 Polybutylene glycol. FR 10110, Mar. 19, 1984] Polyethyleneadipate modified with ethanol- amine with the molar ratio of the amine to § 177.1680 Polyurethane resins. the adipic acid less than 0.1 to 1. The polyurethane resins identified in Poly(oxycarbonylpentamethylene). ′ paragraph (a) of this section may be Polyoxypropylene ethers of 4.4 -isopropyl- idenediphenol (containing an average of 2– safely used as the food-contact surface 4 moles of propylene oxide). of articles intended for use in contact Polypropylene glycol. with bulk quantities of dry food of the α,α′,α″-1,2,3-Propanetriyltris [omega- type identified in § 176.170(c) of this hydroxypoly (oxypropylene) (15–18 moles)], chapter, table 1, under Type VIII, in ac- average molecular weight 3,000. cordance with the following prescribed Propylene glycol. conditions: α,α′,α″-[Propylidynetris (methylene)] tris (a) For the purpose of this section, [omega-hydroxypoly (oxypropylene) (min- imum 1.5 moles)], minimum molecular polyurethane resins are those produced weight 400. when one or more of the isocyanates α-[ρ(1,1,3,3-Tetramethylbutyl) - phenyl]- listed in paragraph (a)(1) of this section omega-hydroxypoly(oxyethylene) (5 moles), is made to react with one or more of average molecular weight 425. the substances listed in paragraph Trimethylol propane. (a)(2) of this section: (b) Optional adjuvant substances em- (1) Isocyanates: ployed in the production of the poly- Bis(isocyanatomethyl) benzene (CAS Reg. urethane resins or added thereto to im- No. 25854–16–4). part desired technical or physical prop- Bis(isocyanatomethyl) cyclohexane (CAS erties may include the following sub- Reg. No. 38661–72–2). stances:
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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) (136Ð170 moles)], av- erage 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 re- quired as an antioxidant. Tetrakis [methyleneÐ(2,5Ðdi-tert-butyl-4-hydroxyhydrocinna- Stabilizer. mate)]methane (CAS Reg. No. 6683Ð19Ð8). 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. 57609Ð64Ð0).
(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 extract- able 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, IVÐB, VI, VIIÐB, (¥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, IVÐB, VI, VIIÐB, 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 con- tainers having a capacity of not less than 160 cc (5.5 fluid ounces) and that the area of the adhesive ex- posed to food shall not exceed 4.03 cm2 (0.625 in2). The pressure-sen- sitive 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 (¥85 0.002 mg/cm2 (0.01 0.002 mg/cm2 (0.01 yl-1,3-butadiene; for use as articles °F) to ¥47 mg/in2) of sur- mg/in2) of sur- or as components of articles that °C (¥53 face at reflux face at 66 °C contact food of Types I, II, IVÐB, VI, °F) and 86 temperature for 2 (150 °F) for 2 hr VIIÐB, and VIII identified in table 1 in °C (187 hr on a 0.071 cm on a 0.071 cm ¤ 176.170(c) of this chapter. °F) to 122 (0.028 in) thick (0.028 in) thick °C (252 sample. (Option- sample. (Option- °F). ally, maximum ally, maximum net residue solu- net residue solu- ble 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 (-58 0.002 mg/cm2 (0.01 0.002 mg/cm2 (0.01 butadiene, hydrogenated (CAS Reg. °F) to -30 mg/in2) of sur- mg/in2) of sur- No. 66070Ð58Ð4): for use as articles °C (-22 °F) face at reflux face at 66 °C or as components of articles that and 92 °C temperature for 2 (150 °F) for 2 hr contact food of Types I, II, IVÐB, VI, (198 °F) to hr on a 0.071 cm on a 0.071 cm VIIÐB, and VIII identified in table 1 in 98 °C (208 (0.028 in) thick (0.028 in) thick ¤ 176.170(c) of this chapter. °F). sample. sample. (ii) Styrene block polymers with 1,3-bu- 16,000 ...... do ...... do ...... do ...... Do. tadiene, hydrogenated (CAS Reg. No. 66070Ð58Ð4): 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, IVÐA, V, VIIÐA, 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- and are applicable to the finished poly- mining whether styrene block poly- mer. mers conform to the specifications pre- scribed in this section are as follows
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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, 200 C St. SW., Washington, DC 20204, or available Styrene-maleic anhydride copoly- for inspection at the Office of the Fed- mers identified in paragraph (a) of this eral Register, 800 North Capitol Street, section may be safely used as articles NW., suite 700, Washington, DC 20408), or components of articles intended for by which the glass transition points use in contact with food, subject to are determined in the tensile mode of provisions of this section. deformation at a frequency of 35 hertz (a) For the purpose of this section, using a Rheovibron Model DDV–II (or styrene-maleic anhydride copolymers 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, IVÐA, IVÐB, V, VIÐB (except that will pass U.S. standard carbonated beverages), VIIÐA, VIIÐB, 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. 27288Ð99Ð9) 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, IVÐA, IVÐB, V, U.S. standard sieve No. 20. VI, VIIÐA, VIIÐB, 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 specifica- tions of this subpart. tions for styrene-maleic anhydride co- [42 FR 14572, Mar. 15, 1977, as amended at 47 polymers prescribed in this section are 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. Styrene-methyl methacrylate co- Residual styrene monomer content polymers identified in this section may shall be determined by the method de- be safely used as components of plastic scribed in § 177.1640(d). articles intended for use in contact (3) Residual maleic anhydride monomer with food, subject to the provisions of content. Residual maleic anhydride this section. monomer content shall be determined (a) For the purpose of this section, by a gas chromatographic method ti- styrene-methyl methacrylate copoly- tled ‘‘Determination of Residual Ma- mers consist of basic copolymers pro- leic Anhydride in Polymers by Gas duced by the copolymerization of sty- Chromatography,’’ which is incor- rene and methyl methacrylate such porated by reference. Copies are avail- that the finished basic copolymers con- able from the Center for Food Safety tain more than 50 weight percent of and Applied Nutrition (HFS–200), Food polymer units derived from styrene. and Drug Administration, 200 C St. (b) The finished plastic food-contact SW., Washington, DC 20204, or available article, when extracted with the sol- for inspection at the Office of the Fed- vent or solvents characterizing the eral Register, 800 North Capitol Street, type of food and under the conditions NW., suite 700, Washington, 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 condi- tion 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 ex- tract, 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 co- polymers. (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 limita- tions 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 methyl- cellulose 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 co- polymers 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 chlo- ride 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 quantitatively transferred to a 250-mil- nitrate 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 nents of the food-contact surface of nitrate 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-pro- pylene 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, 200 C St. late content is determined by an infra- SW., Washington, DC 20204, or available red spectrophotometric method titled for inspection at the Office of the Fed- ‘‘Determination of Copolymer Ratio in Vinylidene Chloride/Methyl Acrylate eral Register, 800 North Capitol Street, Copolymers,’’ which is incorporated by NW., suite 700, Washington, DC 20408. reference. Copies are available from (d) Extractives limitations. The basic the Center for Food Safety and Applied copolymer resin in the form of granules Nutrition (HFS–200), Food and Drug that will pass through a U.S. Standard Administration, 200 C St. SW., Wash- Sieve No. 45 (350 microns) shall meet ington, DC 20204, or available for in- the following extractives limitations: spection at the Office of the Federal (1) 10-gram samples of the resin, Register, 800 North Capitol Street, when extracted separately with 100 NW., suite 700, Washington, DC 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),’’ may be safely used as articles or com- which is incorporated by reference. ponents of articles intended for use in Copies are available from University 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 com- mer 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 tem- peratures 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 may be safely used, subject to the pro- this section. visions of this section, to remove par- (a) Ethylene polymer, chloro- ticles of insoluble matter in producing, sulfonated is produced by chloro- manufacturing, processing, and pre- sulfonation of a carbon tetrachloride paring bulk quantities of liquid food. solution of polyethylene with chlorine (a) Microporous polymeric filters and sulfuryl chloride. consist of a suitably permeable, contin- (b) Ethylene polymer, chloro- uous, polymeric matrix of polyvinyl sulfonated shall meet the following chloride, vinyl chloride-propylene, or specifications: vinyl chloride-vinyl acetate, in which (1) Chlorine not to exceed 25 percent finely divided silicon dioxide is embed- by weight. ded. Cyclohexanone may be used as a (2) Sulfur not to exceed 1.15 percent solvent in the production of the filters. by weight. (b) Any substance employed in the (3) Molecular weight is in the range production of microporous polymeric of 95,000 to 125,000. filters that is the subject of a regula- Methods for the specifications in this tion in parts 170 through 189 of this paragraph (b), titled ‘‘Chlorine and chapter must conform with any speci- Bromine—Coulometric Titration Meth- fication in such regulation. od by Aminco Chloridometer,’’ (c) Cyclohexanone when used as a sol- ‘‘Hypolon Synthetic Rubber—Deter- vent in the production of the filters mination of Sulfur by Parr Bomb,’’ and shall not exceed 0.35 percent by weight ASTM method D2857–70 (Reapproved of the microporous polymeric filters. 1977), ‘‘Standard Test Method for Di- (d) The microporous polymeric filters lute Solution Viscosity of Polymers,’’ may be colored with colorants used in are incorporated by reference. Copies accordance with § 178.3297 of this chap- of the ASTM method may be obtained ter. from the American Society for Testing (e) The temperature of food being Materials, 1916 Race St., Philadelphia, processed through the microporous pol- ° PA 19103. Copies of the other two meth- ymeric filters shall not exceed 180 F. ods are available from the Center for (f) The microporous polymeric filters Food Safety and Applied Nutrition shall be maintained in a sanitary man- (HFS–200), Food and Drug Administra- ner in accordance with good manufac- tion, 200 C St. SW., Washington, DC turing practice so as to prevent poten- 20204. Copies of all three methods may tial microbial adulteration of the food. be examined at the Office of the Fed- (g) To assure safe use of the micro- eral Register, 800 North Capitol Street, porous polymeric filters, the label or NW., suite 700, Washington, DC 20408. labeling shall include adequate direc- (c) The additive is used as the article, tions for a pre-use treatment, con- or a component of articles, intended for sisting of washing with a minimum of use as liners and covers for reservoirs 2 gallons of potable water at a tem- intended for the storage of water for perature of 180 °F for each square foot drinking purposes. of filter, prior to the filter’s first use in (d) Substances permitted by § 177.2600 contact with food. may be employed in the preparation of [42 FR 14572, Mar. 15, 1977, as amended at 56 ethylene polymers, chlorosulfonated, FR 42933, Aug. 30, 1991] subject to any limitations prescribed therein. § 177.2260 Filters, resin-bonded. (e) The finished ethylene copolymers, Resin-bonded filters may be safely chlorosulfonated shall conform to used in producing, manufacturing, § 177.2600(e) and (g). 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 which have been added substances re- § 177.2250 Filters, microporous poly- quired in their preparation and fin- meric. ishing, and which are bonded with res- Microporous polymeric filters identi- ins prepared by condensation or polym- fied in paragraph (a) of this section erization of resin-forming materials,
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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). Mineral oil. employed in the production of the Polybutene, hydrogenated; complying with resin-bonded filter does not exceed the 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. Titanium dioxide. 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with any specifica- (3) Resins: tion in such regulation. Acrylic polymers produced by polymerizing (d) Substances employed in the pro- 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 chap- ter. (2) Substances employed in fiber fin- Melamine-formaldehyde chemically modified ishing: with methyl alcohol. Melamine-formaldehyde chemically modified BHT. with urea; for use only as provided for in Butyl (or isobutyl) palmitate or stearate. paragraphs (e), (f), (g), (h), and (i) of this 2,5-Di-tert-butyl hydroquinone for use only in section. lubricant formulations for rayon fiber fin- Phenol-formaldehyde resins. ishing and at a usage level not to exceed Polyvinyl alcohol. 0.1 percent by weight of the lubricant for- Polyvinyl alcohol with the copolymer of mulations. acrylic acid-allyl sucrose. Dimethylpolysiloxane. Polyvinyl alcohol with melamine formalde- 4-Ethyl-4-hexadecyl morpholinium ethyl sul- hyde. fate for use only as a lubricant in the man- Polyvinyl acetate with melamine formalde- ufacture of polyethylene terephthalate fi- hyde. bers specified in paragraph (d)(1) of this p--Toluenesulfonamide-formaldehyde chemi- section at a level not to exceed 0.03 percent cally modified with one or more of the by weight of the finished fibers. amine catalysts identified in § 175.300 Fatty acid (C -C ) diethanolamide conden- 10 18 (b)(3)(xiii) of this chapter. sates. Fatty acids derived from animal or vegetable (4) Adjuvant substances: fats and oils, and salts of such acids, sin- gle or mixed, as follows: Dimethyl polysiloxane with methylcellulose Aluminum. and sorbic acid (as an antifoaming agent). Ammonium. Phosphoric acid. Calcium. Magnesium. (5) Colorants: Colorants used in ac- Potassium. cordance with § 178.3297 of this chapter. Sodium. (e) Resin-bonded filters conforming Triethanolamine. with the specifications of paragraph (e)
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(1) of this section are used as provided nonalcoholic, aqueous foods having a in paragraph (e)(2) of this section: pH above 5.0. (1) Total extractives. The finished fil- (j) Resin-bonded filters conforming ter, when exposed to distilled water at with the specifications of paragraph (j) 100 °F for 2 hours, yields total extrac- (1) of this section are used as provided tives not to exceed 2.8 percent by in paragraph (j)(2) of this section: weight of the filter. (1) Total extractives. The finished fil- (2) Conditions of use. It is used to fil- ter, when exposed to 5 percent (by ter milk or potable water at operating weight) acetic acid for 2 hours at a temperatures not to exceed 100 °F. temperature equivalent to, or higher (f) Resin-bonded filters conforming than, the filtration temperature of the 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: (1) Total extractives. The finished fil- (g) Resin-bonded filters conforming ter, when exposed to 8 percent (by vol- with the specifications of paragraph (g) ume) ethyl alcohol in distilled water (1) of this section are used as provided for 2 hours at a temperature equivalent in paragraph (g)(2) of this section: to, or higher than, the filtration tem- (1) Total extractives. The finished fil- perature of the alcoholic beverage, ter, when exposed to n-hexane at reflux yields total extractives not to exceed 4 temperature for 2 hours, yields total percent, by weight, of the filter. extractives not to exceed 0.5 percent by (2) Conditions of use. It is used in com- weight of the filter. mercial filtration of bulk quantities of (2) Conditions of use. It is used to fil- alcoholic beverages containing not ter edible oils. more than 8 percent alcohol. (h) Resin-bonded filters conforming (l) Resin-bonded filters conforming with the specifications of paragraph (h) with the specifications of paragraph (l) (1) of this section are used as provided (1) of this section are used as provided in paragraph (h)(2) of this section: in paragraph (l)(2) of this section: (1) Total extractives. The finished fil- (1) Total extractives. The finished fil- ter, when exposed to distilled water at ter, when exposed to 50 percent (by vol- 212 °F for 2 hours, yields total extrac- ume) ethyl alcohol in distilled water tives not to exceed 4 percent by weight for 2 hours at a temperature equivalent of the filter. to, or higher than, the filtration tem- (2) Conditions of use. It is used to fil- perature of the alcoholic beverage, ter milk, coffee, tea, and potable water yields total extractives not to exceed 4 at temperatures not to exceed 212 °F. percent, by weight, of the filter. (i) Resin-bonded filters conforming (2) Conditions of use. It is used in com- with the specifications of paragraph (i) mercial filtration of bulk quantities of (1) of this section are used as provided alcoholic beverages containing more in paragraph (i)(2) of this section: than 8 percent alcohol. (1) Total extractives. The finished fil- (m) Resin-bonded filters fabricated ter, when exposed to distilled water for from acrylic polymers as provided in 2 hours at a temperature equivalent to, paragraph (d)(3) of this section to- or higher than, the filtration tempera- gether with other substances as pro- ture of the aqueous food, yields total vided in paragraph (d), (1), (2), and (4) extractives not to exceed 4 percent, by of this section may be used as follows: weight, of the filter. (1) The finished filter may be used to (2) Conditions of use. It is used in com- filter milk or potable water at oper- mercial filtration of bulk quantities of ating temperatures not to exceed 100
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°F, provided that the finished filter cleansed prior to their first use in con- when exposed to distilled water at 100 tact with food. °F for 2 hours yields total extractives (d) The provisions of this section are not to exceed 1 percent by weight of not applicable to 4,4′-isopropylidenedi- the filter. phenol-epichlorohydrin resins listed in (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 °F, provided that the finished filter [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, when exposed to distilled water at 145 1984] °F for 2 hours yields total extractives not to exceed 1.2 percent by weight of § 177.2355 Mineral reinforced nylon the filter. resins. (n) Acrylonitrile copolymers identi- Mineral reinforced nylon resins iden- fied in this section shall comply with tified in paragraph (a) of this section the provisions of § 180.22 of this chap- may be safely used as articles or com- ter. ponents of articles intended for re- [42 FR 14572, Mar. 15, 1977, as amended at 56 peated use in contact with nonacidic FR 42933, Aug. 30, 1991] food (pH above 5.0) and at use tempera- tures not exceeding 212 °F. in accord- § 177.2280 4,4′-Isopropylidenediphenol- ance with the following prescribed con- epichlorohydrin thermosetting ditions: epoxy resins. (a) For the purpose of this section 4,4′-Isopropylidenediphenol-epichlo- the mineral reinforced nylon resins rohydrin thermosetting epoxy resins consist of nylon 66, as identified in and may be safely used as articles or com- complying with the specifications of ponents of articles intended for re- § 177.1500, reinforced with up to 40 peated use in producing, manufac- weight percent of calcium silicate and turing, packing, processing, preparing, up to 0.5 weight percent 3- treating, packaging, transporting, or (triethoxysilyl) propylamine (Chemical holding food, in accordance with the Abstracts Service Registry No. following prescribed conditions: 000919302) based on the weight of the (a) The basic thermosetting epoxy calcium silicate. resin is made by reacting 4,4′- (b) The mineral reinforced nylon res- isopropylidenediphenol with epichloro- ins may contain up to 0.2 percent by hydrin. (b) The resin may contain one or weight of titanium dioxide as an op- more of the following optional sub- tional adjuvant substance. stances provided the quantity used (c) The mineral reinforced nylon res- does not exceed that reasonably re- ins with or without the optional sub- quired to accomplish the intended ef- stance described in paragraph (b) of fect: this section, and in the form of 1⁄8-inch molded test bars, when extracted with Allyl glycidyl ether ...... As curing system additive. the solvents, i.e., distilled water and 50 Di- and tri-glycidyl ester mix- As modifier at levels not to percent (by volume) ethyl alcohol in ture resulting from the re- exceed equal parts by action of epichlorohydrin weight of the 4,4′- distilled water, at reflux temperature with mixed dimers and isopropylidenediphenol- for 24 hours using a volume-to-surface trimers of unsaturated C18 epichlorohydrin basic resin ratio of 2 milliliters of solvent per monobasic fatty acids de- and limited to use in con- rived from animal and veg- tact with alcoholic bev- square inch of surface tested, shall etable fats and oils. erages containing not more meet the following extractives limita- than 8 percent of alcohol. tions: 1,2-Epoxy-3-phenoxypropane As curing system additive. Glyoxal ...... Do. (1) Total extractives not to exceed 5.0 4,4′-Isopropylidenediphenol ... Do. milligrams per square inch of food-con- 4,4′-Methylenedianiline ...... Do. tact surface tested for each solvent. m-Phenylenediamine ...... Do. Tetrahydrophthalic anhydride Do. (2) The ash after ignition of the ex- tractives described in paragraph (c)(1) (c) In accordance with good manufac- of this section, not to exceed 0.5 milli- turing practice, finished articles con- gram per square inch of food-contact taining the resins shall be thoroughly surface tested.
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(d) In accordance with good manufac- (1) Substances generally recognized turing practice, finished articles con- as safe (GRAS) in food or food pack- taining the mineral reinforced nylon aging. resins shall be thoroughly cleansed (2) Substances used in accordance prior to their first use in contact with with a prior sanction. food. (3) Substances authorized under ap- plicable regulations in this part and in [42 FR 54533, Oct. 7, 1977, as amended at 42 FR parts 175 and 178 of this chapter and 61594, Dec. 6, 1977] subject to any limitations prescribed § 177.2400 Perfluorocarbon cured therein. elastomers. (4) Substances identified in this para- graph (b)(4) subject to such limitations Perfluorocarbon cured elastomers as are provided: identified in paragraph (a) of this sec- tion may be safely used as articles or Substances Limitations components of articles intended for re- Carbon black (channel proc- Not to exceed 15 parts per peated use in contact with nonacid 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. 1333Ð86Ð4). Magnesium oxide (CAS Reg. Not to exceed 5 parts per (a) Identity. (1) For the purpose of No. 1309Ð48Ð4). 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- shall contain no less than 40 weight- tion, 200 C St. SW., Washington, DC percent of polymer units derived from 20204, or available for inspection at the tetrafluoroethylene, no less than 40 Office of the Federal Register, 800 weight-percent of polymer units de- North Capitol Street, NW., suite 700, rived from perfluoromethyl vinyl ether Washington, DC 20408. and no more than 5 weight-percent (2) Thermogravimetry. Perfluorocarbon polymer units derived from perfluoro-2- cured elastomers have a major decom- ° ± ° phenoxy-propyl vinyl ether. position peak occurring at 490 15 C ° (3) The composition limitations of (914 F). Less than 1.5 percent of the ° the cured elastomer, calculated as elastomers will volatilize below 400 C ° parts per 100 parts of terpolymer, are (752 F) when run under nitrogen at a 10 ° ° as follows: C or 18 F per minute heating rate 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 (b) Optional adjuvant substances. The least 1.0 millimeter (0.039 inch) when perfluorocarbon cured elastomer iden- extracted at reflux temperatures for 2 tified in paragraph (a) of this section hours separately with distilled water, may contain the following optional ad- 50 percent ethanol, and n-heptane, juvant substances, subject to any limi- shall meet the following extractability tations cited on their use: limits:
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(1) Total extractives not to exceed 3.1 Glass fiber. milligrams per square decimeter (0.2 Hexamethylenetetramine ...... For use as curing agent. milligrams per square inch). Mica. Oxalic acid ...... For use as catalyst. (2) Fluoride extractives calculated as Zinc stearate ...... For use as lubricant. fluorine not to exceed 0.47 milligram per square decimeter (0.03 milligram (c) The finished food-contact article, per square inch). when extracted with distilled water at (e) Conditions of use. In accordance reflux temperature for 2 hours, using a with current good manufacturing prac- volume-to-surface ratio of 2 milliliters tice, finished food contact articles con- of distilled water per square inch of taining the perfluorocarbon cured surface tested, shall meet the following elastomers shall be thoroughly cleaned extractives limitations: prior to their first use in contact with (1) Total extractives not to exceed food. 0.15 milligram per square inch of food- [49 FR 43050, Oct. 26, 1984] contact surface. (2) Extracted phenol not to exceed § 177.2410 Phenolic resins in molded 0.005 milligram per square inch of food- articles. contact surface. Phenolic resins identified in this sec- (3) No extracted aniline when tested tion may be safely used as the food- by a spectrophotometric method sen- contact surface of molded articles in- sitive to 0.006 milligram of aniline per- tended for repeated use in contact with square inch of food-contact surface. nonacid food (pH above 5.0), in accord- (d) In accordance with good manufac- ance with the following prescribed con- turing practice, finished molded arti- ditions: cles containing the phenolic resins (a) For the purpose of this section, shall be thoroughly cleansed prior to the phenolic resins are those produced their first use in contact with food. when one or more of the phenols listed in paragraph (a)(1) of this section are § 177.2415 Poly(aryletherketone) res- made to react with one or more of the ins. aldehydes listed in paragraph (a)(2) of 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 re- peated use in contact with food subject p-tert-Amylphenol. to the provisions of this section. p-tert-Butylphenol. 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 mo- lecular weight of 12,000, as determined Acetaldehyde. Formaldehyde. by gel permeation chromatography in Paraldehyde. comparison with polystyrene stand- 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. desired technical or physical properties (b) Optional adjuvant substances. The include the following: basic resins identified in paragraph (a) Asbestos fiber. may contain optional adjuvant sub- Barium hydroxide ...... For use as catalyst. stances used in their production. These Calcium stearate ...... For use as lubricant. adjuvants may include substances de- Carbon black (channel proc- ess). scribed in § 174.5(d) of this chapter and Diatomaceous earth. the following:
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Methacrylic. Orthophthalic. Substance Limitations Sebacic. Terephthalic. Diphenyl sulfone ...... Not to exceed 0.2 percent by weight as a residual Trimellitic. solvent in the finished (2) Polyols and polyepoxides: basic resin. Butylene glycol. (c) Extractive limitations. The finished Diethylene glycol. food contact article, when extracted at 2,2-Dimethyl-1,3-propanediol. reflux temperatures for 2 hours with Dipropylene glycol. the following four solvents, yields in Ethylene glycol. each extracting solvent net chloroform Glycerol. 4,4′-Isopropylidenediphenol-epichlorohydrin. soluble extractives not to exceed 0.05 Mannitol. milligrams per square inch of food con- a-Methyl glucoside. tact surface: Distilled water, 50 percent Pentaerythritol. (by volume) ethanol in distilled water, Polyoxypropylene ethers of 4,4′-isopropylide- 3 percent acetic acid in distilled water, nediphenol (containing an average of 2–7.5 and n-heptane. In testing the final food moles of propylene oxide). contact article, a separate test sample Propylene glycol. shall be used for each extracting sol- Sorbitol. Trimethylol ethane. vent. Trimethylol propane. [63 FR 20315, Apr. 24, 1998] 2,2,4-Trimethyl-1,3-pentanediol. (3) Cross-linking agents: § 177.2420 Polyester resins, cross- linked. Butyl acrylate. Cross-linked polyester resins may be Butyl methacrylate. safely used as articles or components Ethyl acrylate. Ethylhexyl acrylate. of articles intended for repeated use in Methyl acrylate. contact with food, in accordance with Methyl methacrylate. the following prescribed conditions: Styrene. (a) The cross-linked polyester resins Triglycidyl isocyanurate (CAS Reg. No. 2451– are produced by the condensation of 62–9), for use only in coatings contacting one or more of the acids listed in para- bulk quantities of dry food of the type graph (a)(1) of this section with one or identified in § 176.170(c) of this chapter, more of the alcohols or epoxides listed table 1, under type VIII. Vinyl toluene. in paragraph (a)(2) of this section, fol- lowed by copolymerization with one or (b) Optional adjuvant substances em- more of the cross-linking agents listed ployed to facilitate the production of in paragraph (a)(3) of this section: the resins or added thereto to impart (1) Acids: desired technical or physical properties include the following, provided that Adipic. the quantity used does not exceed that Fatty acids, and dimers thereof, from nat- ural sources. reasonably required to accomplish the Fumaric. intended physical or technical effect Isophthalic. and does not exceed any limitations Maleic. 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. Calcium naphthenate. Cobalt naphthenate. Copper naphthenate. N, N-Diethylaniline ...... 0.4 percent.
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Limitations (limits of addition expressed as percent by weight List of substances of finished resin)
N, N-Dimethylaniline ...... Do. Ethylene guanidine hydrochloride ...... 0.05 percent. 3. Catalysts: Total not to exceed 1.5 percent, except that methyl ethyl ke- tone 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. 818Ð08Ð6) ...... For use in the polycondensation reaction at levels not to ex- ceed 0.2 percent of the polyester resin. Dicumyl peroxide. Hydroxybutyltin oxide (CAS Reg. No. 2273Ð43Ð0) ...... For use in the polycondensation reaction at levels not to ex- ceed 0.2 percent of the polyester resin. Lauroyl peroxide. p-Menthane hydroperoxide. Methyl ethyl ketone peroxide. Monobutyltin tris(2-ethylhexoate) (CAS Reg. No. 23850Ð For use in the polycondensation reaction at levels not to ex- 94Ð4). ceed 0.2 percent of the polyester resin. 4. Solvents for inhibitors, accelerators, and catalysts: Butyl benzyl phthalate (containing not more than 1.0 per- cent by weight of dibenzyl phthalate). Dibutyl phthalate. Diethylene glycol ...... As a solvent for benzyl trimethyl ammonium chloride or ethyl- ene 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 sec- tion with one or more of the alcohols listed in paragraph (a)(2) of this section. 6. Miscellaneous materials: Castor oil, hydrogenated. α-Methylstyrene. Polyethylene glycol 6000. Silicon dioxide. Wax, petroleum ...... Complying with ¤ 178.3710 of this chapter.
(c) The cross-linked polyester resins, of food-contact surface tested when the with or without the optional sub- prescribed food-simulating solvent is stances described in paragraph (b) of heptane. this section, and in the finished form in (d) In accordance with good manufac- which they are to contact food, when turing practice, finished articles con- extracted with the solvent or solvents taining the cross-linked polyester res- characterizing the type of food and ins shall be thoroughly cleansed prior under the conditions of time and tem- to their first use in contact with food. perature characterizing the conditions of their intended use, as determined [42 FR 14572, Mar. 15, 1977, as amended at 48 from tables 1 and 2 of § 176.170(c) of this FR 37618, Aug. 19, 1983; 54 FR 48858, Nov. 28, chapter, shall meet the following ex- 1989] tractives limitations: (1) Net chloroform-soluble extrac- § 177.2430 Polyether resins, chlorinated. tives not to exceed 0.1 milligram per square inch of food-contact surface Chlorinated polyether resins may be tested when the prescribed food-simu- safely used as articles or components lating solvent is water or 8 or 50 per- of articles intended for repeated use in cent alcohol. producing, manufacturing, packing, (2) Total nonvolatile extractives not processing, preparing, treating, pack- to exceed 0.1 milligram per square inch aging, transporting, or holding food, in
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accordance with the following pre- List of substances Limitations scribed conditions: Diphenylsulfone ...... Not to exceed 0.2 percent as re- (a) The chlorinated polyether resins sidual solvent in the finished are produced by the catalytic polym- basic resin described in para- erization of 3,3-bis(chloromethyl)- graph (a)(1) of this section. 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 para- (b) In accordance with good manufac- graph (a)(1) of this section. turing practice, finished articles con- N-methyl-2-pyrrolidone ..... Not to exceed 0.01 percent as 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 aver- age molecular weight of 26,000. [44 FR 34493, June 15, 1979, as amended at 47 FR 38885, Sept. 3, 1982; 49 FR 10111, Mar. 19, (3) In paragraphs (a)(1) and (a)(2) of 1984; 50 FR 47211, Nov. 15, 1985; 60 FR 48648, this section, the minimum number av- Sept. 20, 1995] erage molecular weight is determined by reduced viscosity in dimethyl form- § 177.2450 Polyamide-imide resins. amide in accordance with ASTM meth- Polyamide-imide resins identified in od D2857–70 (Reapproved 1977), ‘‘Stand- paragraph (a) of this section may be ard Test Method for Dilute Solution safely used as components of articles Viscosity of Polymers,’’ which is incor- intended for repeated use in contact porated by reference. Copies may be with food, in accordance with the fol- obtained from the American Society lowing prescribed conditions: for Testing Materials, 1916 Race St., (a) Identity. (1) For the purpose of Philadelphia, PA 19103, or may be ex- this section the polyamide-imide resins amined at the Division of Petition Con- are derived from the condensation re- trol (HFS–215), Center for Food Safety action of substantially equimolar parts and Applied Nutrition, 1110 Vermont of trimellitic anhydride and p,p′- Ave. NW., suite 1200, Washington, DC, diphenylmethane diisocyanate. or at the Office of the Federal Register, (2) The polyamide-imide resins (CAS 800 North Capitol St. NW., suite 700, Reg. No. 31957–38–7) derived from the Washington, DC. condensation reaction of equimolar (b) The basic resins identified in parts of benzoyl chloride-3,4- paragraphs (a)(1) and (a)(2) of this sec- dicarboxylic anhydride and 4,4′- tion may contain optional adjuvant diphenylmethanediamine. substances described in § 174.5(d) of this (b) Specifications. (1) Polyamide-imide chapter and the following: resins identified in paragraph (a)(1) of
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this section shall have a nitrogen con- 200), Food and Drug Administration, tent of not less than 7.8 weight percent 200 C St. SW., Washington, DC 20204, or and not more than 8.2 weight percent. available for inspection at the Office of Polyamide-imide resins identified in the Federal Register, 800 North Capitol paragraph (a)(2) of this section shall Street, NW., suite 700, Washington, have a nitrogen content of not less DC). than 7.5 weight percent and not more (c) Extractive limitations are appli- than 7.8 weight percent. Nitrogen con- cable to the polyamide-imide resins tent is determined by the Dumas Nitro- identified in paragraphs (a) (1) and (2) gen Determination as set forth in the of this section in the form of films of 1 ‘‘Official Methods of Analysis of the mil uniform thickness after coating Association of Official Analytical and heat curing at 600 °F for 15 minutes Chemists,’’ 13th Ed. (1980), sections on stainless steel plates, each having 7.016–7.020, which is incorporated by such resin-coated surface area of 100 reference in accordance with 5 U.S.C. square inches. The cured-resin film 552(a). Copies may be obtained from the coatings shall be extracted in accord- Association of Official Analytical ance with the method described in Chemists International, 481 North § 176.170(d)(3) of this chapter, using a Frederick Ave., suite 500, Gaithersburg, plurality of spaced, coated stainless MD 20877–2504, or may be examined at steel plates, exposed to the respective the Office of the FEDERAL REGISTER, 800 North Capitol Street, NW., suite food simulating solvents. The resin 700, Washington, DC. shall meet the following extractive (2) Polyamide-imide resins identified limitations under the corresponding in paragraph (a)(1) of this section shall extraction conditions: have a solution viscosity of not less (1) Distilled water at 250 °F for 2 than 1.200. Polyamide-imide resins hours: Not to exceed 0.01 milligram per identified in paragraph (a)(2) of this square inch. section shall have a solution viscosity (2) Three percent acetic acid at 212 °F of not less than 1.190. Solution vis- for 2 hours: Not to exceed 0.05 milli- cosity shall be determined by a method gram per square inch. titled ‘‘Solution Viscosity’’ which is in- (3) Fifty percent ethyl alcohol at 160 corporated by reference in accordance °F for 2 hours: Not to exceed 0.03 milli- with 5 U.S.C. 552(a). Copies are avail- gram per square inch. able from the Center for Food Safety (4) n-Heptane at 150 °F for 2 hours: and Applied Nutrition (HFS–200), Food Not to exceed 0.05 milligram per square and Drug Administration, 200 C St. inch. SW., Washington, DC 20204, or available (d) In accordance with good manufac- for inspection at the Office of the FED- turing practice, those food contact ar- ERAL REGISTER, 800 North Capitol ticles, having as components the poly- Street, NW., suite 700, Washington, DC. amide-imide resins identified in para- (3) The polyamide-imide resins iden- graph (a) of this section and intended tified in paragraph (a)(1) of this section for repeated use shall be thoroughly ° are heat cured at 600 F for 15 minutes cleansed prior to their first use in con- when prepared for extraction tests and tact with food. the residual monomers: p,p- 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] 500 parts per million. Residual mono- mers are determined by gas chroma- § 177.2460 Poly(2,6-dimethyl-1,4-phen- ylene) oxide resins. tography (the gas chromatography method titled ‘‘Amide-Imide Polymer The poly(2,6-dimethyl-1,4-phenylene) Analysis—Analysis of Monomer Con- oxide resins identified in paragraph (a) tent,’’ is incorporated by reference in of this section may be used as an arti- accordance with 5 U.S.C. 552(a). Copies cle or as a component of an article in- are available from the Center for Food tended for use in contact with food sub- Safety and Applied Nutrition (HFS– ject to the provisions of this section.
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(a) Identity. For the purposes of this (iii) Viscometer: Cannno-Ubbelohde se- section, poly(2,6-dimethyl-1,4-phen- ries 25 dilution viscometer (or equiva- ylene) oxide resins consist of basic res- lent). ins produced by the oxidative coupling (iv) Calculation: The calculation of 2,6-xylenol such that the finished method used is that described in appen- basic resins meet the specifications dix X.1.3 (ASTM method D1243–79, cited and extractives limitations prescribed and incorporated by reference in para- in paragraph (c) of this section. graph (c)(1) of this section) with the re- (b) Optional adjuvant substances. The duced viscosity determined for three basic poly(2,6-dimethyl-1,4-phenylene) concentration levels (0.4, 0.2, and 0.1 oxide resins identified in paragraph (a) gram per deciliter) and extrapolated to of this section may contain optional zero concentration for intrinisic vis- adjuvant substances required in the cosity. The following formula is used production of such basic resins. The op- for determining reduced viscosity: tional adjuvant substances required in − the production of the basic poly(2,6-di- Reduced viscosity in terms = tto methyl-1,4-phenylene) oxide resins may of deciliters per gram tc× include substances permitted for such o use by regulations in parts 170 through where: 189 of this chapter, substances gen- t=Solution efflux time. erally recognized as safe in food, sub- to=Solvent efflux time. stances used in accordance with a prior c=Concentration of solution in terms of sanction or approval, and the fol- grams per deciliter. lowing: (2) Extractives limitations. Total resin extracted not to exceed 0.02 weight-per- Limitations (expressed as List of substances percent by weight of finished cent when extracted with n-heptane at basic resin) 160 °F for 2 hours as determined using 200 milliliters of reagent grade n- Diethylamine ...... Not to exceed 0.16 percent as residual catalyst. heptane which has been freshly dis- Methyl alcohol ...... Not to exceed 0.02 percent tilled before use and 25 grams of poly as residual solvent. (2,-6-dimethyl-1,4-phenylene) oxide Toluene ...... Not to exceed 0.2 percent as resin. The resin as tested is in pellet residual solvent. form having a particle size such that (c) Specifications and extractives limita- 100 percent of the pellets will pass tions. The poly(2,6-dimethyl-1,4-phen- through a U.S. Standard Sieve No. 6 and 100 percent of the pellets will be ylene) oxide basic resins meet the fol- held on a U.S. Standard Sieve No. 10. lowing: (d) Other limitations. The poly(2,6-di- (1) Specifications. Intrinsic viscosity methyl-1,4-phenylene) oxide resins is not less than 0.30 deciliter per gram identified in and complying with this as determined by ASTM method D1243– section, when used as components of 79, ‘‘Standard Test Method for Dilute the food-contact surface of any article Solution Viscosity of Vinyl Chloride that is the subject of a regulation in Polymers,’’ which is incorporated by parts 174, 175, 176, 177, 178 and § 179.45 of reference, modified as follows. Copies this chapter, shall comply with any of the incorporation by reference may specifications and limitations pre- be obtained from the American Society scribed by such regulation for the arti- for Testing Materials, 1916 Race St., cle in the finished form in which it is Philadelphia, PA 19103, or may be ex- to contact food. amined at the Office of the Federal (e) Uses. The poly(2,6-dimethyl-1,4- Register, 800 North Capitol Street, phenylene) oxide resins identified in NW., suite 700, Washington, DC 20408. and complying with the limitations in (i) Solvent: Chloroform, reagent grade this section may be used as articles or containing 0.01 percent tert- components of articles intended for re- butylcatechol. peated food-contact use or as articles (ii) Resin sample: Powdered resin ob- or components of articles intended for tained from production prior to mold- single-service food-contact use only ing or extrusion. under the conditions described in
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§ 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)meth- Melamine-formaldehyde resin. ′ acrylate copolymers are used at levels 2,2 -Methylenebis(4-methyl-6-tert-butyl- phenol). not to exceed 6.0 percent by weight of Nylon 6/66, weight ratio 2/3. the 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. § 176.170(c) of this chapter. (c) Specifications. (1) Polyoxymeth- 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, 200 C St. SW., Washington, DC (a) Identity. For the purpose of this 20204, or available for inspection at the section, polyoxymethylene copolymers Office of the Federal Register, 800 are identified as the following: The re- North Capitol Street, NW., suite 700, action product of trioxane (cyclic 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, trimer of formaldehyde) and a max- when extracted with the solvent or sol- imum of 5 percent by weight of vents characterizing the type of food butanediol formal (CAS Reg. No. 25214 and under conditions of time and tem- 85–1). Both copolymers may have cer- perature as determined from tables 1 tain optional substances added to im- and 2 of § 175.300(d) of this chapter,
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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 re- sanction, substances permitted under tained on a U.S.A. Standard Sieve No. applicable regulations in this part, and 10, shall yield total extractives as fol- the following: lows: (1) Stabilizers. The homopolymer may (i) Not to exceed 0.20 percent by contain one or more of the following weight of the copolymer when ex- stabilizers. The total amount of stabi- tracted for 6 hours with distilled water lizers shall not exceed 1.9 percent of at reflux temperature. homopolymer by weight, and the quan- (ii) Not to exceed 0.15 percent by tity of individual stabilizer used shall weight of the copolymer when ex- not exceed the limitations set forth tracted for 6 hours with n-heptane at below: reflux temperature. (e) Conditions of use. (1) The Substances Limitations polyoxymethylene copolymer is for use Hexamethylenebis(3,5-di-tert- At a maximum level of 1 per- as articles or components of articles butyl-4-hydroxy-hydro- cent by weight of homo- intended for repeated use. cinnamate) (CAS Reg. No. polymer. The finished arti- 35074Ð77Ð2). cles shall not be used for (2) Use temperature shall not exceed foods containing more than 250 °F. 8 percent alcohol. (3) In accordance with good manufac- 2,2′-Methylenebis(4-methyl-6- At a maximum level of 0.5 tert-butylphenol). percent by weight of turing practice, finished articles con- homopolymer. taining polyoxymethylene copolymer Nylon 66/610/6 terpolymer, At a maximum level of 1.5 shall be thoroughly cleansed before respective proportions of percent by weight of their first use in contact with food. nylon polymers by weight homopolymer. are: 3/2/4. [42 FR 14572, Mar. 15, 1977, as amended at 48 Nylon 612/6 copolymer (CAS Do. FR 56204, Dec. 20, 1983; 49 FR 5748, Feb. 15, Reg. No. 51733-10-9), weight ratio 6/1. 1984; 50 FR 1842, Jan. 14, 1985; 50 FR 20560, Tetrakis[methylene(3,5-di-tert- At a maximum level of 0.5 May 17, 1985; 52 FR 4493, Feb. 12, 1987, 54 FR butyl-4-hydroxy-hydro- percent by weight of 24898, June 12, 1989] cinnamate)] methane. homopolymer.
§ 177.2480 Polyoxymethylene (2) Lubricant. N,N′-Distearoylethyl- homopolymer. enediamine. Polyoxymethylene homopolymer (3) Molding assistant. Polyethylene identified in this section may be safely glycol 6,000. used as articles or components of arti- (c) Specifications. (1) cles intended for food-contact use in Polyoxymethylene homopolymer can accordance with the following pre- be identified by its characteristic in- scribed conditions: frared spectrum. (a) Identity. For the purpose of this (2) Minimum number average molec- section, polyoxymethylene homopoly- ular weight of the homopolymer is mer is polymerized formaldehyde 25,000. [Chemical Abstracts Service Registry (3) Density of the homopolymer is be- No. 9002–81–7]. Certain optional adju- tween 1.39 and 1.44 as determined by vant substances, described in para- ASTM method D1505–68 (Reapproved graph (b) of this section, may be added 1979), ‘‘Standard Test Method for Den- to impart desired technological prop- sity of Plastics by the Density-Gra- erties to the homopolymer. dient Technique,’’ which is incor- (b) Optional adjuvant substances. The porated by reference. Copies may be polyoxymethylene homopolymer iden- obtained from the American Society tified in paragraph (a) of this section for Testing Materials, 1916 Race St., may contain optional adjuvant sub- Philadelphia, PA 19103, or may be ex- stances in its production. The quantity amined at the Office of the Federal
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Register, 800 North Capitol Street, articles or components of articles in- NW., suite 700, Washington, DC 20408. tended for repeated use. (4) Melting point is between 172 °C (2) Use temperature shall not exceed and 184 °C as determined by ASTM 250 °F. method D2133–66, ‘‘Specifications for (3) In accordance with good manufac- Acetal Resin Injection Molding and Ex- turing practice, finished articles con- trusion Materials’’ (Revised 1966), taining polyoxymethylene which is incorporated by reference. homopolymer shall be thoroughly Copies are available from American So- cleansed prior to first use in contact ciety for Testing and Materials with food. (ASTM), 1916 Race Street, Philadel- [42 FR 14572, Mar. 15, 1977, as amended at 43 phia, PA 19103, or available for inspec- FR 44835, Sept. 29, 1978; 47 FR 11846, Mar. 19, tion at the Office of the Federal Reg- 1982; 47 FR 51562, Nov. 16, 1982; 49 FR 10111, ister, 800 North Capitol Street, NW., Mar. 19, 1984; 54 FR 24898, June 12, 1989] suite 700, Washington, DC 20408. (d) Extractive limitations. (1) § 177.2490 Polyphenylene sulfide res- Polyoxymethylene homopolymer, in ins. the finished form which is to contact Polyphenylene sulfide resins food, when extracted with the solvent (poly(1,4-phenylene sulfide) resins) may or solvents characterizing the type of be safely used as coatings or compo- food and under conditions of time and nents of coatings of articles intended temperature characterizing the condi- for repeated use in contact with food, tions of intended use under paragraphs in accordance with the following pre- (c)(3) and (d) of § 175.300 of this chapter scribed conditions. and as limited by paragraph (e) of this (a) Polyphenylene sulfide resins con- section, shall yield net chloroform- sist of basic resins produced by the re- soluble extractives not to exceed 0.5 action of equimolar parts of p- milligram per square inch of food-con- dichlorobenzene and sodium sulfide, tact surface. such that the finished resins meet the (2) Polyoxymethylene homopolymer, following specifications as determined with or without the optional adjuvant by methods titled ‘‘Oxygen Flask Com- substances described in paragraph (b) bustion-Gravimetric Method for Deter- of this section, when ground or cut into mination of Sulfur in Organic Com- particles that pass through a U.S.A. pounds,’’ ‘‘Determination of the Inher- Standard Sieve No. 6 and that are re- ent Viscosity of Polyphenylene Sul- tained on a U.S.A. Standard Sieve No. fide,’’ and ‘‘Analysis for 10, shall yield extractives as follows: Dichlorobenzene in Ryton (i) Formaldehyde not to exceed 0.0050 Polyphenylene Sulfide,’’ which are in- percent by weight of homopolymer as corporated by reference. Copies are determined by a method titled ‘‘Form- available from the Center for Food aldehyde Release and Formaldehyde Safety and Applied Nutrition (HFS– Analysis,’’ which is incorporated by 200), Food and Drug Administration, reference. Copies are available from 200 C St. SW., Washington, DC 20204, or Center for Food Safety and Applied Nu- available for inspection at the Office of trition (HFS–200) Food and Drug Ad- the Federal Register, 800 North Capitol ministration, 200 C St. SW., Wash- Street, NW., suite 700, Washington, DC ington, DC 20204, or available for in- 20408. spection at the Office of the Federal (1) Sulfur content: 28.2–29.1 percent Register, 800 North Capitol Street, by weight of finished resin. NW., suite 700, Washington, DC 20408. (2) Minimum inherent viscosity: 0.13 (ii) Total extractives not to exceed deciliters per gram. 0.20 percent by weight of homopolymer (3) Maximum residual p- when extracted for 6 hours with dis- dichlorobenzene: 0.8 ppm. tilled water at reflux temperature and (b) Subject to any limitations pre- 0.15 percent by weight of homopolymer scribed in parts 170 through 189 of this when extracted for 6 hours with n- chapter, the following optional sub- heptane at reflux temperature. stances may be added to the (e) Conditions of use. (1) Polyoxy- polyphenylene sulfide basic resins in an methylene homopolymer is for use as amount not to exceed that reasonably
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required to accomplish the intended (a) Identity. For the purpose of this physical or technical effect. section, polyphenylene sulfone resins (1) Substances generally recognized consist of basic resin produced by re- as safe in food. acting polyphenylene sulfide with per- (2) Substances used in accordance acetic acid such that the finished res- with prior sanction or approval. ins meet the specifications set forth in (3) Substances the use of which is paragraph (c) of this section. The permitted in coatings under regula- polyphenylene sulfide used to manufac- tions in parts 170 through 189 of this ture polyphenylene sulfone is prepared chapter. by the reaction of sodium sulfide and p- (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 in contact with food at temperatures [65 FR 15058, Mar. 21, 2000] up to and including normal baking and frying temperatures; provided that the § 177.2510 Polyvinylidene fluoride res- finished cured coating, when extracted ins. at reflux temperatures for 2 hours sepa- Polyvinylidene fluoride resins may rately with distilled water, 50 percent be safely used as articles or compo- ethanol in water, 3 percent acetic acid nents of articles intended for repeated and heptane, yields total extractives in use in contact with food, in accordance each extracting solvent not to exceed with the following prescribed condi- 0.2 milligram per square inch of surface tions: and when extracted at reflux tempera- (a) For the purpose of this section, ture for 1 hour with diphenyl ether the polyvinylidene fluoride resins con- yields total extractives not to exceed sist of basic resins produced by the po- 4.5 milligrams per square inch of sur- lymerization of vinylidene fluoride. face. (b) The finished food-contact article, [42 FR 14572, Mar. 15, 1977, as amended at 47 when extracted at reflux temperatures FR 11846, Mar. 19, 1982; 54 FR 24898, June 12, for 2 hours with the solvents distilled 1989] water, 50 percent (by volume) ethyl al- cohol in distilled water, and n-heptane, § 177.2500 Polyphenylene sulfone res- yields total extractives in each ex- ins. tracting solvent not to exceed 0.01 mil- The polyphenylene sulfone resins ligram per square inch of food-contact (CAS Reg. No. 31833–61–1) identified in surface tested; and if the finished food- paragraph (a) of this section may be contact article is itself the subject of a safely used as articles or components regulation in parts 174, 175, 176, 177, 178 of articles intended for repeated use in and § 179.45 of this chapter, it shall also contact with food, subject to the provi- comply with any specifications and sions of this section. limitations prescribed for it by that
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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.) dichloride, and 1,4-benzenedicarbonyl (c) In accordance with good manufac- dichloride (CAS Reg. No. 39443–76–0). turing practice, finished food-contact The membrane is the food contact sur- articles containing the polyvinylidene face and may be applied as a film on a fluoride resins shall be thoroughly suitable support. Its maximum weight cleansed prior to their first use in con- is 512 milligrams per square decimeter tact with food. (33 milligrams per square inch). (4) A cross-linked high molecular § 177.2550 Reverse osmosis mem- weight polyamide reaction product of branes. poly(N-vinyl-N-methylamine) (CAS Substances identified in paragraph Reg. No. 31245–56–4), N,N′-bis(3- (a) of this section may be safely used as aminopropyl)ethylenediamine (CAS reverse osmosis membranes intended Reg. No. 10563–26–5), 1,3- for use in processing bulk quantities of benzenedicarbonyl dichloride (CAS liquid food to separate permeate from Reg. No. 99–63–8) and 1,3,5- food concentrate or in purifying water benzenetricarbonyl trichloride (CAS for food manufacturing under the fol- Reg. No. 4422–95–1). The membrane is lowing prescribed conditions: the food-contact surface. Its maximum (a) Identity. For the purpose of this weight is 20 milligrams per square deci- section, reverse osmosis membranes meter (1.3 milligrams per square inch) may consist of either of the following as a thin film composite on a suitable formulations: support. (1) A cross-linked high molecular (5) A polyamide reaction product of weight polyamide reaction product of 1,3,5-benzenetricarbonyl trichloride 1,3,5-benzenetricarbonyl trichloride polymer (CAS Reg. No. 4422–95–1) with with 1,3-benzenediamine (CAS Reg. No. piperazine (CAS Reg. No. 110–85–0) and 83044–99–9) or piperazine (CAS Reg. No. 1,2-diaminoethane (CAS Reg. No. 107– 110–85–0). The membrane is on the food- 15–3). The membrane is the food-con- contact surface, and its maximum tact layer and may be applied as a film weight is 62 milligrams per square deci- on a suitable support. Its maximum meter (4 milligrams per square inch) as weight is 15 milligrams per square deci- a thin film composite on a suitable meter (1 milligram per square inch). support. (b) Optional adjuvant substances. The (2) A cross-linked polyetheramine basic polymer identified in paragraph (CAS Reg. No. 101747–84–6), identified as (a) of this section may contain optional the copolymer of epichlorohydrin, 1,2- adjuvant substances required in the ethanediamine and 1,2-dichloroethane, production of such basic polymer. whose surface is the reaction product These optional adjuvant substances of this copolymer with 2,4- may include substances permitted for toluenediisocyanate (CAS Reg. No. of such use by regulations in parts 170 the final polymer is 99811–80–0) for use through 186 of this chapter, substances as the food-contact surface of reverse generally recognized as safe in food, osmosis membranes used in processing and substances used in accordance with liquid food. The composite membrane a prior sanction or approval. is on the food-contact surface and its (c) Supports. Suitable supports for re- maximum weight is 4.7 milligrams per verse osmosis membranes are mate- square decimeter (0.3 milligrams per rials permitted for such use by regula- square inch) as a thin film composite tions in parts 170 through 186 of this on a suitable support. The maximum chapter, substances generally recog- weight of the 2,4-toluenediisocyanate nized as safe in food, and substances component of the thin film composite used in accordance with a prior sanc- is 0.47 milligrams per square decimeter tion or approval. (0.03 milligrams per square inch). (d) Conditions of use. (1) Reverse os- (3) For the purpose of this section, mosis membranes described in para- the reverse osmosis membrane consists graphs (a)(1), (a)(2), (a)(3), and (a)(5) of of a polyaramide identified as 2,4- this section may be used in contact
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with all types of liquid food at tem- (4) Substances identified in this para- peratures up to 80 °C (176 °F). graph (c)(4), provided that any sub- (2) Reverse osmosis membranes de- stance that is the subject of a regula- scribed in paragraph (a)(4) of this sec- tion in parts 174, 175, 176, 177, 178 and tion may be used in contact with all § 179.45 of this chapter conforms with types of liquid food, except food con- any specification in such regulation. taining more than 8 percent alcohol, at (i) Elastomers. ° ° temperatures up to 80 C (176 F). Acrylonitrile-butadiene copolymer. (3) Reverse osmosis membranes shall Brominated isobutylene-isoprene copolymers be maintained in a sanitary manner in complying with § 177.1210. accordance with current good manufac- Butadiene-acrylonitrile-ethylene glycol turing practice so as to prevent micro- dimethacrylate copolymers containing not bial adulteration of food. more than 5 weight percent of polymer units derived from ethylene glycol (4) To assure their safe use, reverse dimethacrylate. osmosis membranes and their supports Butadiene-acrylonitrile-methacrylic acid co- shall be thoroughly cleaned prior to polymer. their first use in accordance with cur- Butadiene-styrene-methacrylic acid copoly- rent good manufacturing practice. mer. Chloroprene polymers. [49 FR 49448, Dec. 20, 1984, as amended at 52 Chlorotrifluoroethylene-vinylidene fluoride FR 29668, Aug. 11, 1987; 53 FR 31835, Aug. 22, copolymer. 1988; 53 FR 32215, Aug. 24, 1988; 55 FR 8139, Ethylene-propylene copolymer elastomers Mar. 7, 1990; 59 FR 9925, Mar. 2, 1994] which may contain not more than 5 weight-percent of total polymer units de- § 177.2600 Rubber articles intended for rived from 5-methylene-2-norbornene and/ repeated use. or 5-ethylidine-2-norbornene. Rubber articles intended for repeated Ethylene-propylene-dicyclopentadiene co- polymer. use may be safely used in producing, Ethylene-propylene-1,4-hexadiene copoly- manufacturing, packing, processing, mers containing no more than 8 weight preparing, treating, packaging, trans- percent of total polymer units derived porting, or holding food, subject to the from 1,4-hexadiene. provisions of this section. Hydrogenated butadiene/acrylonitrile co- (a) The rubber articles are prepared polymers (CAS Reg. No. 88254–10–8) pro- from natural and/or synthetic polymers duced when acrylonitrile/butadiene copoly- 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 (b) The quantity of any substance unsaturation and no α, β-olefinic employed in the production of rubber unsaturation as determined by a method articles intended for repeated use shall entitled ‘‘Determination of Residual α, β- not exceed the amount reasonably re- Olefinic and Trans Olefinic Unsaturation quired to accomplish the intended ef- Levels in HNBR,’’ developed October 1, 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 great- (c) Substances employed in the prep- er than 45 (ML 1 + 4 @ 100 °C), as deter- aration of rubber articles include the mined by ASTM Standard Method D1646– following, subject to any limitations 92, ‘‘Standard Test Method for Rubber— prescribed: Viscosity and Vulcanization Characteris- tics (Mooney Viscometer),’’ which are both (1) Substances generally recognized incorporated by reference in accordance as safe for use in food or food pack- with 5 U.S.C. 552(a) and 1 CFR part 51. Cop- aging. ies of these methods may be obtained from (2) Substances used in accordance the Division of Petition Control (HFS–215), with the provisions of a prior sanction Center for Food Safety and Applied Nutri- or approval. tion, Food and Drug Administration, 200 C (3) Substances that by regulation in St. SW., Washington, DC 20204, or may be examined at the Center for Food Safety parts 170 through 189 of this chapter and Applied Nutrition’s Library, 200 C St. may be safely used in rubber articles, SW., rm. 3321, Washington, DC, or at the subject to the provisions of such regu- Office of the Federal Register, 800 North lation. Capitol St. NW., suite 700, Washington, DC.
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A copy of ASTM Standard Method D1646–92 Vinylidene fluoride-hexafluoropropylene co- may also be obtained from the American polymers (minimum number average mo- Society for Testing and Materials, 100 Barr lecular weight 70,000 as determined by os- Harbor Dr., West Conshohocken, PA 19428– motic pressure in methyl ethyl ketone). 2959. Vinylidene fluoride-hexafluoropropylene- Isobutylene-isoprene copolymer. tetrafluoroethylene copolymers (minimum Polyamide/polyether block copolymers (CAS number average molecular weight 100,000 Reg. No. 77402–38–1 prepared by reacting a as determined by osmotic pressure in copolymer of omega-laurolactam and adipic methyl ethyl ketone). acid with poly(tetramethylene ether gly- col). The polyamide and polyether compo- (ii) Vulcanization materials—(a) Vul- nents are reacted in ratios such that the canizing agents. polyamide component constitutes a min- 4,4′-Bis(aminocyclohexyl)methane carbamate imum of 30 weight-percent of total polymer for use only as cross-linking agent in the units. The copolymers may be used in con- vulcanization of vinylidene tact with foods of Types I, II, III, IV, V, VI, fluoridehexafluoropropylene copolymer 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, α butanediol, and -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 Rubber and Rubber Latices—Nomen- (b) Accelerators (total not to exceed 1.5 clature,’’ which is incorporated by ref- percent by weight of rubber product). erence. Copies may be obtained from the American Society for Testing Materials, 2-Benzothiazyl-N,N-diethylthiocarbamyl-sul- 1916 Race St., Philadelphia, PA 19103, or fide. may be examined at the Office of the Fed- Benzoyl peroxide. eral Register, 800 North Capitol Street, 1,3-Bis(2-benzothiazolylmercaptomethyl) NW., suite 700, Washington, DC 20408. urea. N-tert-Butyl-2-benzothiazole sulfenamide. Silicone (Si) elastomers containing methyl Butyraldehyde-aniline resin (iodine number groups. 670–705). Silicone (Psi) elastomers containing meth- Carbon disulfide-1,1′-methylenedipiperidine yl and phenyl groups. reaction product. Silicone (Vsi) elastomers containing meth- Copper dimethyldithiocarbamate. yl and vinyl groups. N-Cyclohexyl-2-benzothiazole sulfenamide. Silicone (Fsi) elastomers containing meth- Dibenzoyl-p-quinone dioxime. yl and fluorine groups. Dibenzylamine. Silicone (PVsi) elastomers containing Diisopropyl xanthogen polysulfide (a 1:2:1 phenyl, methyl, and vinyl groups. mixture of O,O-di(1-methylethyl)trithio- Styrene-butadiene copolymer. bis-thioformate, O,O-di(1-
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methylethyl)tetrathio-bis-thioformate, Phthalic anhydride. and O,O-di(1-methylethyl)pentathio-bis- Salicylic acid. thioformate). Di(4-methylbenzoyl) peroxide (CAS Reg. No. (d) Activators (total not to exceed 5 per- 895–85–2) for use only as a crosslinking cent by weight of rubber product except agent in silicone polymers and elastomers magnesium oxide may be used at higher identified under paragraph (c)(4)(i) of this levels). 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. 1,2-Dihydro-2,2,4-trimethyl-6- butyl peroxide]. phenylquinoline. Tetramethylthiuram monosulfide. 4,4′-Dimethoxydiphenylamine. Thiram (tetramethylthiuram disulfide). 4,6-Dinonyl-o-cresol. Triallyl cyanurate. N,N′-Dioctyl-p-phenylenediamine. Triethylenetetramine. Diphenylamine-acetone resin. 1,3,5-Triethyl-hexahydro-s-triazine Diphenylamine-acetone-formaldehyde resin. (triethyltrimethylenetriamine). N,N′-Diphenylethylenediamine. Triphenylguanidine. N,N′-Disalicylalpropylenediamine. Zinc butyl xanathate. N,N′-Di-o-tolylethylenediamine. Zinc dibenzyl dithiocarbamate. Hydroquinone monobenzyl ether. Zinc dibutyldithiocarbamate. Isopropoxydiphenylamine. Zinc diethyldithiocarbamate. N-Isopropyl-N′-phenyl-p-phenylenediamine. Zinc 2-mercaptobenzothiazole. 2,2′-Methylenebis(6-tert-butyl-4-ethylphenol). Ziram (zinc dimethyldithiocarbamate). 2,2′-Methylenebis(4-methyl-6-tert-butyl- (c) Retarders (total not to exceed 10 per- phenol). cent of weight of rubber product). 2,2′-Methylenebis(4-methyl-6-nonylphenol). 2,2′-Methylenebis(4-methyl-6-tert- Cyanoguanidine. octylphenol).
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Monooctyl- and dioctyldiphenylamine. Diphenyl ketone. N,N′-Di-β-naphthyl-p-phenylenediamine. Fatty acids. Phenyl-a-naphthylamine. Fatty acids, hydrogenated. Phenyl-β-naphthylamine. Isooctyl ester of tall oil fatty acids. Phenyl-β-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. (iv) Plasticizers (total not to exceed 30 Polybutene. percent by weight of rubber product un- Polystyrene. Propylene glycol. less otherwise specified). n-Propyl ester of tall oil fatty acids. n-Amyl n-decyl phthalate. Rapeseed oil vulcanized with rubber maker’s Butylacetyl ricinoleate. sulfur. n-Butyl ester of tall oil fatty acids. Rosins and rosin derivatives identified in Butyl laurate. § 175.105(c)(5) of this chapter. Butyl oleate. Soybean oil vulcanized with rubber maker’s Butyl stearate. sulfur. Calcium stearate. Styrene-acrylonitrile copolymer. Castor oil. Terpene resins. Coumarone-indene resins. Triethylene glycol dicaprate. 2,2′-Dibenzamidodiphenyl disulfide. Triethylene glycol dicaprylate. Dibenzyl adipate. Waxes, petroleum. Dibutoxyethoxyethyl adipate. Xylene (or toluene) alkylated with Dibutyl phthalate. dicyclopentadiene. Dibutyl sebacate. Zinc 2-benzamidothiophenate. Didecyl adipate. (v) Fillers. Didecyl phthalate. Diisodecyl adipate. Aluminum hydroxide. Diisodecyl phthalate. Aluminum silicate. Diisooctyl adipate. Asbestos fiber, chrysotile or crocidolite. Diisooctyl sebacate. Barium sulfate. Dioctyl adipate. Carbon black (channel process or furnace Dioctyl phthalate. combustion process; total carbon black not Dioctyl sebacate. to exceed 50 percent by weight of rubber Dipentene resin. product; furnace combustion black content
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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 chemical blowing agent. cordance with § 178.3297 of this chapter. Phenothiazine. (vii) Lubricants (total not to exceed 2 Potassium persulfate. percent by weight of rubber product). Sodium formaldehyde sulfoxylate. Sodium polysulfide. Polyethylene. Sodium nitrite. Sodium stearate. 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. food shall meet the following specifica- Azodicarbonamide as chemical blowing tions: The food-contact surface of the agent. 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. square inch during the first 7 hours of 2634–33–5) for use as a biocide in uncured extraction, nor to exceed 1 milligram liquid rubber latex not to exceed 0.02 per- 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. article in the finished form in which it tert-Butyl peracetate. is to contact food, when extracted with p-tert-Butylpyrocatechol. ¥ n-hexane at reflux temperature, shall Dialkyl (C8 C18 Di- and triethanolamine. yield total extractives not to exceed Diethyl xanthogen disulfide. 175 milligrams per square inch during 4-(Diiodomethylsulfonyl) toluene, Chemical the first 7 hours of extraction, nor to Abstracts Service Registry No. 20018–09–01, exceed 4 milligrams per square inch for use as an antifungal preservative at during the succeeding 2 hours of ex- levels not to exceed 0.3 percent by weight traction. of the sealants and caulking materials. Dodecyl mercaptan isomers, single or mixed. (g) In accordance with good manufac- 2-Ethoxyethanol. turing practice finished rubber articles Iodoform. intended for repeated use in contact p-Menthane hydroperoxide. with food shall be thoroughly cleansed
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prior to their first use in contact with § 177.2800 Textiles and textile fibers. food. Textiles and textile fibers may safely (h) The provisions of this section are be used as articles or components of ar- not applicable to rubber nursing-bottle ticles intended for use in producing, nipples. manufacturing, packing, processing, (i) Acrylonitrile copolymers identi- preparing, treating, packaging, trans- fied in this section shall comply with porting, or holding food, subject to the the provisions of § 180.22 of this chap- provisions of this section. ter. (a) The textiles and textile fibers are [42 FR 14572, Mar. 15, 1977] prepared from one or more of the fibers EDITORIAL NOTE: For FEDERAL REGISTER ci- identified in paragraph (d) of this sec- tations affecting § 177.2600, see the List of tion and from certain other adjuvant CFR Sections Affected, which appears in the substances required in the production Finding Aids section of the printed volume of the textiles or textile fibers or added and on GPO Access. to impart desired properties. § 177.2710 Styrene-divinylbenzene res- (b) The quantity of any adjuvant sub- ins, cross-linked. stance employed in the production of textiles or textile fibers does not ex- Styrene-divinylbenzene cross-linked ceed the amount reasonably required copolymer resins may be safely used as to accomplish the intended physical or articles or components of articles in- technical effect or any limitation fur- tended for repeated use in producing, ther provided. manufacturing, packing, processing, (c) Any substance employed in the preparing, treating, packaging, trans- production of textiles or textile fibers porting, or holding food, in accordance that is the subject of a regulation in with the following prescribed condi- parts 174, 175, 176, 177, 178 and § 179.45 of tions: this chapter conforms with any speci- (a) The resins are produced by the co- fication in such regulation. polymerization of styrene with divinylbenzene. (d) Substances employed in the pro- (b) The resins meet the extractives duction of or added to textiles and tex- limitations prescribed in this para- tile fibers may include: graph: (1) Substances generally recognized (1) The resins to be tested are ground as safe in food. or cut into small particles that will (2) Substances subject to prior sanc- pass through a U.S. standard sieve No. tion or approval for use in textiles and 3 and that will be held on a U.S. stand- textile fibers and used in accordance ard sieve No. 20. with such sanction or approval. (2) A 100-gram sample of the resins, (3) Substances generally recognized when extracted with 100 milliliters of as safe for use in cotton and cotton fab- ethyl acetate at reflux temperature for rics used in dry-food packaging. 1 hour, yields total extractives not to (4) Substances that by regulation in exceed 1 percent by weight of the res- this part may safely be used in the pro- ins. duction of or as a component of tex- (c) In accordance with good manufac- tiles or textile fibers and subject to turing practice, finished articles con- provisions of such regulation. taining the resins shall be thoroughly (5) Substances identified in this para- cleansed prior to their first use in con- graph (d)(5), subject to such limitations tact with food. as are provided:
List of substances Limitations
(i) Fibers: Cotton. 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.
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List of substances Limitations
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 pre- ceding item reacted with one or more of the following sub- stances: 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 400Ð3,000). 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 deriva- tive). N-Oleyl, N′-acetyl, N′-β-hydroxy-ethylenediamine. Petrolatum. Petroleum sulfonate. Pine oil. Polybutene, hydrogenated; complying with the identity pre- scribed 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. Ultramarine blue. Waxes, petroleum. Zinc hydrosulfite.
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(e) Textile and textile fibers are used practice so as to prevent potential mi- as articles or components of articles crobial adulteration of the food. that contact dry food only. (e) Ultrafiltration membranes identi- (f) The provisions of this section are fied in paragraph (a)(4) may be used to not applicable to jute fibers used as filter aqueous or acidic foods con- prescribed by § 178.3620(d)(2) of this taining up to 13 percent of alcohol at chapter. temperatures not to exceed 21 °C (70 °F). [42 FR 14572, Mar. 15, 1977, as amended at 46 (f) To assure safe use of the ultra-fil- FR 37042, July 17, 1981; 49 FR 4372, Feb. 6, tration membranes, the label or label- 1984; 49 FR 5748, Feb. 15, 1984; 56 FR 42933, Aug. 30, 1991] ing shall include adequate directions for a pre-use treatment, consisting of § 177.2910 Ultra-filtration membranes. conditioning and washing with a min- imum of 8 gallons of potable water Ultra-filtration membranes identi- prior to their first use in contact with fied in paragraphs (a)(1), (a)(2), (a)(3), food. and (a)(4) of this section may be safely (g) Acrylonitrile copolymers identi- used in the processing of food, under fied in this section shall comply with the following prescribed conditions; the provisions of § 180.22 of this chap- (a)(1) Ultra-filtration membranes ter. that consist of paper impregnated with cured phenol-formaldehyde resin, [42 FR 14572, Mar. 15, 1977, as amended at 53 which is used as a support and is coat- FR 17925, May 19, 1988; 58 FR 48599, Sept. 17, ed with a vinyl chloride-acrylonitrile 1993; 60 FR 54426, Oct. 24, 1995] copolymer. (2) Ultra-filtration membranes that PART 178—INDIRECT FOOD ADDI- consist of a sintered carbon support TIVES: ADJUVANTS, PRODUCTION that is coated with zirconium oxide AIDS, AND SANITIZERS (CAS Reg. No. 1314–23–4) containing up to 12 percent yttrium oxide (CAS Reg. Subpart A [Reserved] No. 1314–36–9). (3) Ultra-filtration membranes that Subpart B—Substances Utilized To Control consist of an aluminum oxide support the Growth of Microorganisms that is coated with zirconium oxide Sec. (CAS Reg. No. 1314–23–4) containing up 178.1005 Hydrogen peroxide solution. to 5 percent yttrium oxide (CAS Reg. 178.1010 Sanitizing solutions. No. 1314–36–9). Subpart C—Antioxidants and Stabilizers (4) Ultrafiltration membranes that consist of a microporous 178.2010 Antioxidants and/or stabilizers for poly(vinylidene fluoride) membrane polymers. with a hydrophilic surface modifier 178.2550 4-Hydroxymethyl-2,6-di-tert-butyl- consisting of hydroxypropyl acrylate/ phenol. tetraethylene glycol diacrylate copoly- 178.2650 Organotin stabilizers in vinyl chlo- ride plastics. mer. (b) Any substance employed in the Subpart D—Certain Adjuvants and production of ultra-filtration mem- Production Aids branes that is the subject of a regula- tion in parts 174, 175, 176, 177, 178 and 178.3010 Adjuvant substances used in the § 179.45 of this chapter conforms with manufacture of foamed plastics. 178.3120 Animal glue. the specifications of such regulation. 178.3125 Anticorrosive agents. (c) Ultra-filtration membranes are 178.3130 Antistatic and/or antifogging used in the physical separation of dis- agents in food-packaging materials. solved or colloidally suspended varying 178.3280 Castor oil, hydrogenated. molecular size components of liquids 178.3290 Chromic chloride complexes. during the commercial processing of 178.3295 Clarifying agents for polymers. bulk quantities of food. 178.3297 Colorants for polymers. 178.3300 Corrosion inhibitors used for steel (d) Ultra-filtration membranes shall or tinplate. be maintained in a sanitary manner in 178.3400 Emulsifiers and/or surface-active accordance with good manufacturing agents.
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178.3450 Esters of stearic and palmitic acids. faces identified in paragraph (e)(1) of 178.3480 Fatty alcohols, synthetic. this section. 178.3500 Glycerin, synthetic. (a) Identity. For the purpose of this 178.3505 Glyceryl tri-(12-acetoxystearate). section, hydrogen peroxide solution is 178.3520 Industrial starch-modified. an aqueous solution containing not 178.3530 Isoparaffinic petroleum hydro- carbons, synthetic. more than 35 percent hydrogen per- 178.3570 Lubricants with incidental food oxide (CAS Reg. No. 7722–84–1) by contact. weight, meeting the specifications pre- 178.3600 Methyl glucoside-coconut oil ester. scribed in paragraph (c) of this section. 178.3610 a-Methylstyrene-vinyltoluene res- (b) Optional adjuvant substances. Hy- ins, hydrogenated. drogen peroxide solution identified in 178.3620 Mineral oil. paragraph (a) of this section may con- 178.3650 Odorless light petroleum hydro- tain substances generally recognized as carbons. safe in or on food, substances generally 178.3690 Pentaerythritol adipate–stearate. 178.3700 Petrolatum. recognized for their intended use in 178.3710 Petroleum wax. food packaging, substances used in ac- 178.3720 Petroleum wax, synthetic. cordance with a prior sanction or ap- 178.3725 Pigment dispersants. proval, and substances permitted by 178.3730 Piperonyl butoxide and pyrethrins applicable regulations in parts 174 as components of bags. through 179 of this chapter. 178.3740 Plasticizers in polymeric sub- (c) Specifications. Hydrogen peroxide stances. solution shall meet the specifications 178.3750 Polyethylene glycol (mean molec- ular weight 200–9,500). of the ‘‘Food Chemicals Codex,’’ 3d Ed. 178.3760 Polyethylene glycol (400) (1981), pp. 146–147, which is incorporated monolaurate. by reference (copies may be obtained 178.3770 Polyhydric alcohol esters of from the National Academy Press, 2101 oxidatively refined (Gersthofen process) Constitution Ave. NW., Washington, montan wax acids. DC 20418, or may be examined at the 178.3780 Polyhydric alcohol esters of long Office of the Federal Register, 800 chain monobasic acids. North Capitol Street, NW., suite 700, 178.3790 Polymer modifiers in semirigid and Washington, DC 20408), and the United rigid vinyl chloride plastics. 178.3800 Preservatives for wood. States Pharmacopeia XX (1980), except 178.3850 Reinforced wax. that hydrogen peroxide may exceed the 178.3860 Release agents. concentration specified therein. 178.3870 Rosins and rosin derivatives. (d) Limitations. No use of hydrogen 178.3900 Sodium pentachlorophenate. peroxide solution in the sterilization of 178.3910 Surface lubricants used in the man- food packaging material shall be con- ufacture of metallic articles. sidered to be in compliance if more 178.3930 Terpene resins. than 0.5 part per million of hydrogen 178.3940 Tetraethylene glycol di-(2-ethyl- hexoate). peroxide can be determined in distilled 178.3950 Tetrahydrofuran. water packaged under production con- ditions (assay to be performed imme- AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. diately after packaging). SOURCE: 42 FR 14609, Mar. 15, 1977, unless (e) Conditions of use. (1) Hydrogen per- otherwise noted. oxide solution identified in and com- EDITORIAL NOTE: Nomenclature changes to plying with the specifications in this part 178 appear at 61 FR 14482, Apr. 2, 1996. section may be used by itself or in combination with other processes to Subpart A [Reserved] treat food-contact surfaces to attain commercial sterility at least equiva- lent to that attainable by thermal Subpart B—Substances Utilized To processing for metal containers as pro- Control the Growth of Micro- vided for in part 113 of this chapter. organisms Food-contact surfaces include the fol- lowing: § 178.1005 Hydrogen peroxide solution. Hydrogen peroxide solution identi- Substances Limitations fied in this section may be safely used Ethylene-acrylic acid Complying with ¤ 177.1310 of this to sterilize polymeric food-contact sur- copolymers. chapter.
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Substances Limitations and components which are permitted by prior sanction or approval. Ethylene-carbon mon- Complying with ¤ 177.1312 of this oxide copolymers. chapter. (1) An aqueous solution containing Ethylene-methyl acry- Complying with ¤ 177.1340 of this potassium, sodium, or calcium hypo- late copolymer resins. chapter. chlorite, with or without the bromides Ethylene-vinyl acetate Complying with ¤ 177.1350 of this of potassium, sodium, or calcium. copolymers. chapter. Ionomeric resins ...... Complying with ¤ 177.1330 of this (2) An aqueous solution containing chapter. dichloroisocyanuric acid, Isobutylene polymers ... Complying with ¤ 177.1420 (a)(1) trichloroisocyanuric acid, or the so- and (a)(2) of this chapter. dium or potassium salts of these acids, Olefin polymers ...... Complying with ¤ 177.1520 of this chapter. with or without the bromides of potas- Polycarbonate resins ... Complying with ¤ 177.1580 of this sium, sodium, or calcium. chapter. (3) An aqueous solution containing Polyethylene- Complying with ¤ 177.1630 of this potassium iodide, sodium p- terephthalate poly- chapter (excluding polymers de- mers. scribed in ¤ 177.1630(c)) of this toluenesulfonchloroamide, and sodium chapter. lauryl sulfate. Poly-l-butene resins Complying with ¤ 177.1570 of this (4) An aqueous solution containing and butene/ethylene chapter. copolymers. iodine, butoxy monoether of mixed Polystryrene and rub- Complying with ¤ 177.1640 of this (ethylene-propylene) polyalkylene gly- ber-modified poly- chapter. col having a cloudpoint of 90°–100 °C in styrene polymers. 0.5 percent aqueous solution and an av- Vinylidene chloride/ Complying with ¤ 177.1990 of this methyl acrylate co- chapter. erage molecular weight of 3,300, and polymers. ethylene glycol monobutyl ether. Addi- tionally, the aqueous solution may (2) The packaging materials identi- contain diethylene glycol monoethyl fied in paragraph (e)(1) of this section ether as an optional ingredient. may be used for packaging all commer- (5) An aqueous solution containing cially sterile foods except that the elemental iodine, hydriodic acid, a-(p- olefin polymers may be used in articles nonylphenyl)-omega-hydroxypoly-(oxy- for packaging foods only of the types ethylene) (complying with the identity identified in § 176.170(c) of this chapter, prescribed in § 178.3400(c) and having a table 1, under Categories I, II, III, IV– maximum average molecular weight of B, V, and VI. 748) and/or polyoxyethylene- (3) Processed foods packaged in the polyoxypropylene block polymers (hav- materials identified in paragraph (e)(1) ing a minimum average molecular of this section shall conform with parts weight of 1,900). Additionally, the aque- 108, 110, 113, and 114 of this chapter as ous solution may contain isopropyl al- applicable. cohol as an optional ingredient. (6) An aqueous solution containing [46 FR 2342, Jan. 9, 1981, as amended at 49 FR 10111, Mar. 19, 1984; 49 FR 32345, Aug. 14, 1984; elemental iodine, sodium iodide, so- 49 FR 37747, Sept. 26, 1984; 51 FR 45881, Dec. dium dioctylsulfosuccinate, and 23, 1986; 52 FR 26146, July 13, 1987; 53 FR 47186, polyoxyethylene-polyoxypropylene Nov. 22, 1988; 54 FR 5604, Feb. 6, 1989; 54 FR block polymers (having a minimum av- 13167, Mar. 31, 1989; 54 FR 6365 Feb. 9, 1989; 55 erage molecular weight of 1,900). FR 47055, Nov. 9, 1990; 57 FR 32423, July 22, (7) An aqueous solution containing 1992] dodecylbenzenesulfonic acid and either isopropyl alcohol or polyoxyethylene- § 178.1010 Sanitizing solutions. polyoxypropylene block polymers (hav- Sanitizing solutions may be safely ing a minimum average molecular used on food-processing equipment and weight of 2,800). In addition to use on utensils, and on other food-contact ar- food-processing equipment and uten- ticles as specified in this section, with- sils, this solution may be used on glass in the following prescribed conditions: bottles and other glass containers in- (a) Such sanitizing solutions are tended for holding milk. used, followed by adequate draining, (8) An aqueous solution containing before contact with food. elemental iodine, butoxy monoether of (b) The solutions consist of one of the mixed (ethylene-propylene) following, to which may be added com- polyalkylene glycol having a minimum ponents generally recognized as safe average molecular weight of 2,400 and
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α-lauroyl-omega-hydroxypoly (oxy- (13) An aqueous solution containing ethylene) with an average 8–9 moles of elemental iodine and alkyl (C12-C15) ethylene oxide and an average molec- monoether of mixed (ethylene-pro- ular weight of 400. In addition to use on pylene) polyalkylene glycol, having a food-processing equipment and uten- cloud-point of 70°–77 °C in 1 percent sils, this solution may be used on bev- aqueous solution and an average mo- erage containers, including milk con- lecular weight of 807. tainers or equipment. Rinse water (14) An aqueous solution containing treated with this solution can be recir- iodine, butoxy monoether of mixed culated as a preliminary rinse. It is not (ethylene-propylene) polyalkylene gly- to be used as final rinse. col, having a cloud-point of 90°–100 °C (9) An aqueous solution containing n- in 0.5 percent aqueous solution and an alkyl (C12-C18) benzyldimethylam- average molecular weight of 3,300, and monium chloride compounds having polyoxyethylene-polyoxypropylene average molecular weights of 351 to 380. block polymers (having a minimum av- The alkyl groups consist principally of erage molecular weight of 2,000). groups with 12 to 16 carbon atoms and (15) An aqueous solution containing contain not more than 1 percent each lithium hypochlorite. of groups with 8 and 10 carbon atoms. (16) An aqueous solution containing Additionally, the aqueous solution may equal amounts of n-alkyl (C12-C18) ben- contain either ethyl alcohol or iso- zyl dimethyl ammonium chloride and propyl alcohol as an optional ingre- n-alkyl (C12-C14) dimethyl ethylbenzyl dient. ammonium chloride (having average (10) An aqueous solution containing molecular weights of 377 to 384), with trichloromelamine and either sodium the optional adjuvant substances lauryl sulfate or dodecyl- tetrasodium ethylenediaminetetra- benzenesulfonic acid. In addition to use acetate and/or alpha-(p-nonylphenol)- on food-processing equipment and omega-hydroxy poly (oxyethylene) hav- utensils and other food-contact arti- ing an average poly- (oxyethylene) con- cles, this solution may be used on bev- tent of 11 moles. Alpha-hydro-omega- erage containers except milk con- hydroxypoly-(oxyethylene) tainers or equipment. poly(oxypropoylene) (15 to 18 mole (11) An aqueous solution containing minimum) poly (oxyethylene) block co- equal amounts of n-alkyl (C12-C18) ben- polymer, having a minimum molecular zyl dimethyl ammonium chloride and weight of 1,900 (CAS Registry No. 9003– n-alkyl (C12-C18) dimethyl ethylbenzyl 11–6) may be used in lieu of alpha- (p- ammonium chloride (having an average nonylphenol)-omega-hydroxy- molecular weight of 384). In addition to poly(oxyethylene) having an average use on food-processing equipment and poly(oxyethylene) content of 11 moles. utensils, this solution may be used on In addition to use on food-processing food-contact surfaces in public eating equipment and utensils, this solution places. may be used on food-contact surfaces (12) An aqueous solution containing in public eating places. the sodium salt of sulfonated oleic (17) An aqueous solution containing acid, polyoxyethylene- di-n-alkyl(C8-C10)dimethyl ammonium polyoxypropylene block polymers (hav- chlorides having average molecular ing an average molecular weight of weights of 332–361 and either ethyl al- 2,000 and 27 to 31 moles of cohol or isopropyl alcohol. In addition polyoxypropylene). In addition to use to use on food-processing equipment on food-processing equipment and and utensils, this solution may be used utensils, this solution may be used on on food-contact surfaces in public eat- glass bottles and other glass containers ing places. intended for holding milk. All equip- (18) An aqueous solution containing ment, utensils, glass bottles, and other n-alkyl(C12-C18) benzyldimethylammo- glass containers treated with this sani- nium chloride, sodium metaborate, tizing solution shall have a drainage alpha-terpineol and alpha[p-(1,1,3,3- period of 15 minutes prior to use in tetramethylbutyl)phenyl] -omega-hy- contact with food. droxy-poly (oxyethylene) produced
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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 (oxy- (28) An aqueous solution containing ethylene) sulfate with the sulfonated 9-octadecenoic acid (CAS poly(oxyethylene) content averaging Reg. No. 68988–76–1) and sodium one mole, potassium salts of coconut xylenesulfonate (CAS Reg. No. 1300–72– oil fatty acids, and isopropyl alcohol or 7). hexylene glycol. (29) An aqueous solution containing (21) An aqueous solution containing dodecyldiphenyloxidedisulfonic acid sodium dodecylbenzenesulfonate. In ad- (CAS Reg. No. 30260–73–2), sulfonated dition to use on food-processing equip- tall oil fatty acid (CAS Reg. No. 68309– ment and utensils, this solution may 27–3), and neo-decanoic acid (CAS Reg. be used on glass bottles and other glass No. 26896–20–8). In addition to use on containers intended for holding milk. food-processing equipment and uten- (22) An aqueous solution containing sils, this solution may be used on glass (1) di-n-alkyl(C8-C10) bottles and other glass containers in- dimethylammonium chloride com- tended for holding milk. pounds having average molecular (30) An aqueous solution containing weights of 332–361, (2) n-alkyl (C12-C18) hydrogen peroxide (CAS Reg. No. 7722– benzyldimethylammonium chloride 84–1), peracetic acid (CAS Reg. No. 79– compounds having average molecular 21–0), acetic acid (CAS Reg. No. 64–19– weights of 351–380 and consisting prin- 7), and 1-hydroxyethylidene-1,1- cipally of alkyl groups with 12 to 16 diphosphonic acid (CAS Reg. No. 2809– carbon atoms with or without not over 21–4). 1 percent each of groups with 8 and 10 (31) An aqueous solution containing carbon atoms, and (3) ethyl alcohol. elemental iodine, alpha-alkyl(C10-C14)- The ratio of compound (1) to compound omega-hydroxypoly(oxyethylene)poly- (2) is 60 to 40. (oxypropylene) of average molecular (23) An aqueous solution containing weight between 768 and 837, and alpha- n-alkyl (C12-C16) benzyl- alkyl(C12-C18)-omega- dimethylammonium chloride and hydroxypoly(oxyethylene) didecyldimethylammonium chloride. poly(oxypropylene) of average molec- (24) An aqueous solution containing ular weight between 950 and 1,120. In elemental iodine (CAS Reg. No. 7553–56– addition to use on food-processing 2), alpha-[p-(1,1,3,3-tetramethylbutyl)- equipment and utensils, this solution phenyl]-omega-hydroxypoly-(oxy- may be used on food-contact surfaces ethylene) produced with one mole of in public eating places. the phenol and 4 to 14 moles ethylene (32) An aqueous solution containing oxide, and alpha-alkyl(C12-C15)-omega- (i) di-n-alkyl(C8–C10)dimethyl- ammo- hydroxy[poly(oxyethylene) nium chloride compounds having aver- poly(oxypropylene)] (having an average age molecular weights of 332 to 361, (ii) molecular weight of 965). n-alkyl(C12–C18)benzyldimethyl- ammo- (25) An aqueous solution containing nium chloride compounds having aver- elemental iodine (CAS Reg. No. 7553–56– age molecular weights of 351 to 380 and 2), potassium iodide (CAS Reg. No. consisting principally of alkyl groups 7681–11–0), and isopropanol (CAS Reg. with 12 to 16 carbon atoms with no No. 67–63–0). In addition to use on food more than 1 percent of groups with 8 processing equipment and utensils, this and 10, (iii) ethyl alcohol, and (iv)
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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– 2) and a mixture of the sodium salt of 19–7); sulfuric acid (CAS Reg. No. 7664– naphthalenesulfonic acid (CAS Reg. 93–9); and 2,6-pyridinedicarboxylic acid No. 1321–69–3); the methyl, dimethyl, (CAS Reg. No. 499–83–2). In addition to and trimethyl dervatives of the sodium use on food-processing equipment and salt of naphthalenesulfonic acid; and a utensils, this solution may be used on mixture of the sodium salt of dairy-processing equipment. naphthalenesulfonic acid, and the (39) An aqueous solution containing methyl, dimethyl, and trimethyl de- phosphoric acid (CAS Reg. No. 7664–38– rivatives of the sodium salt of 2); octenyl succinic acid (CAS Reg. No. naphthalenesulfonic acid alkylated at 3 28805–58–5); N,N-dimethyloctanamine percent by weight with C6–C9 linear (CAS Reg. No. 7378–99–6); and a mixture 345
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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 al- acid. In addition to use on food-proc- cohol (CAS Reg. No. 67–63–0); and cal- essing equipment and utensils, this so- cium chloride (CAS Reg. No. 10043–52– lution may be used on food-contact 4). In addition to use on food-proc- surfaces in public eating places, sub- essing equipment and utensils, this so- ject to the limitations in paragraph lution may be used on dairy-processing (c)(39) of this section. equipment. (46) An aqueous solution of chlorine (41) An aqueous solution containing dioxide and related oxychloro species n-alkyl(C12- generated by acidification of an aque- C16)benzyldimethylammonium chlo- ous solution of sodium chlorite with a ride, having average molecular weights solution of sodium gluconate, citric ranging from 351 to 380 wherein the acid, phosphoric acid, and sodium alkyl groups contain principally 12 to mono- and 16 carbons and not more than 1 percent didodecylphenoxybenzenedisulfonate. each of the groups with 8 and 10 carbon In addition to use on food-processing atoms; ammonium chloride (CAS Reg. equipment and utensils, this solution No. 12125–02–9); calcium stearate (CAS may be used on dairy-processing equip- Reg. No. 1592–23–0); sodium bicarbonate ment. (CAS Reg. No. 144–55–8); starch or (c) The solutions identified in para- dextrin, or both starch and dextrin graph (b) of this section will not exceed (CAS Reg. No. 9004–53–9); and the op- the following concentrations: tional ingredient methylene blue (CAS (1) Solutions identified in paragraph Reg. No. 61–73–4). In addition to use on (b)(1) of this section will provide not food-processing equipment and uten- more than 200 parts per million of sils, this solution may be used on food- available halogen determined as avail- contact surfaces in public eating able chlorine. places. (2) Solutions identified in paragraph (42) An aqueous solution containing (b)(2) of this section will provide not decanoic acid (CAS Reg. No. 334–48–5), more than 100 parts per million of nonanoic acid (CAS Reg. No. 112–05–0), available halogen determined as avail- phosphoric acid (CAS Reg. No. 7664–38– able chlorine. 2), propionic acid (CAS Reg No. 79–09– (3) Solution identified in paragraph 04), and sodium 1-octanesulfonate (CAS (b)(3) of this section will provide not Reg. No. 5324–84–5). Sulfuric acid (CAS more than 25 parts per million of ti- Reg. No. 7664–93–9) may be added as an tratable iodine. The solutions will con- optional ingredient. In addition to use tain the components potassium iodide, on food-processing equipment and sodium p-toluenesulfonchloramide and utensils, this solution may be used on sodium lauryl sulfate at a level not in dairy-processing equipment. excess of the minimum required to (43) An aqueous solution of iodine produce their intended functional ef- and hypochlorous acid generated by fect.
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(4) Solutions identified in paragraph more than 200 parts per million of ac- (b)(4), (5), (6), (8), (13), and (14) of this tive quaternary compound and not section will contain iodine to provide more than 66 parts per million of not more than 25 parts per million of alpha[p-(1,1,3,3-tetramethylbutyl) titratable iodine. The adjuvants used phenyl]-omega-hydroxypoly (oxy- with the iodine will not be in excess of ethylene). the minimum amounts required to ac- (14) Solutions identified in paragraph complish the intended technical effect. (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 pro- per 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] available chlorine and not more than 30 (22) Solutions identified in paragraph ppm lithium. (b)(27) of this section shall provide, (11) Solutions identified in paragraph when ready to use, at least 109 parts (b)(16) of this section shall provide not per million and not more than 218 parts more than 200 parts per million of ac- per million of total active fatty acids tive quaternary compound. and at least 156 parts per million and (12) Solutions identified in paragraph not more than 312 parts per million of (b)(17) of this section shall provide, the sodium 1-octanesulfonate. when ready to use, a level of 150 parts (23) Solutions identified in paragraph per million of the active quaternary (b)(28) of this section shall provide, compound. when ready to use, at least 156 parts (13) Solutions identified in paragraph per million and not more than 312 parts (b)(18) of this section shall provide not per million of sulfonated 9-
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octadecenoic acid, at least 31 parts per of these sanitizing solutions shall be million and not more then 62 parts per limited to conditions of water hardness million of sodium xylenesulfonate. not in excess of 300 parts per million. (24) Solutions identified in paragraph (29) Solutions identified in paragraph (b)(29) of this section will provide at (b)(34) of this section should provide, least 237 parts per million and not when ready to use, at least 100 parts more than 474 parts per million per million and not more than 200 parts dodecyldiphenyloxidedisulfonic acid, at per million available chlorine dioxide least 33 parts per million and not more as determined by the method titled than 66 parts per million sulfonated ‘‘Iodometric Method for the Deter- tall oil fatty acid, and at least 87 parts mination of Available Chlorine Dioxide per million and not more than 174 parts (50–250 ppm available ClO2),’’ which is per million neo-decanoic acid. 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 200 C St. SW., Washington, DC 20204, or 1,100 parts per million hydrogen per- available for inspection at the Office of oxide, not less than 100 parts per mil- the Federal Register, 800 North Capitol lion and not more than 200 parts per Street, NW., suite 700, Washington, DC million peracetic acid, not less than 150 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 acid. per million of total fatty acids and at (26) The solution identified in para- least 166 parts per million and not graph (b)(31) of this section shall pro- more than 332 parts per million of a vide, when ready to use, at least 12.5 mixture of naphthalenesulfonates. The parts per million and not more than 25 adjuvants phosphoric acid and lactic parts per million of titratable iodine. acid, used with decanoic acid, octanoic The adjuvants used with the iodine will acid, and sodium naphthalenesulfonate not be in excess of the minimum and its alkylated derivatives, will not amounts required to accomplish the in- be in excess of the minimum amounts tended technical effect. required to accomplish the intended (27) Solutions identified in paragraph technical effects. (b)(32) of this section shall provide, (31) Solutions identified in paragraph when ready to use, at least 150 parts (b)(36) of this section shall provide, per million and no more than 400 parts when ready for use, at least 29 parts per per million of active quarternary com- million and not more than 58 parts per pounds in solutions containing no more million decanoic acid; at least 88 parts than 600 parts per million water hard- per million and not more than 176 parts ness. The adjuvants used with the per million of octanoic acid; at least 69 quarternary compounds will not exceed parts per million and not more than 138 the amounts required to accomplish parts per million of lactic acid; at least the intended technical effect. 256 parts per million and not more than (28) Solutions identified in paragraph 512 parts per million of phosphoric (b)(33) of this section shall provide, acid; at least 86 parts per million and when ready to use, at least 150 parts not more than 172 parts per million of per million and not more than 400 parts 1-octanesulfonic acid; at least 51 parts per million of active quaternary com- per million and not more than 102 parts pounds. The adjuvants used with the per million of 1-octanesulfonic-2- quaternary compounds shall not exceed sulfinic acid or 1,2-octanedisulfonic the amounts required to accomplish acid; and at least 10 parts per million the intended technical effect. and not more than 20 parts per million Tetrasodium ethylenediamine of the condensate of four moles of tetraacetate shall be added at a min- poly(oxyethylene)poly(oxypropylene) imum level of 60 parts per million. Use block copolymers with one mole of
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ethylenediamine. The colorant adju- (34) Solutions identified in paragraph vant FD&C Yellow No. 5 shall not be (b)(39) of this section shall provide used in excess of the minimum amount when ready for use not less than 460 required to accomplish the intended parts per million and not more than 625 technical effect. parts per million of phosphoric acid, (32)(i) The solution identified in para- and all components shall be present in graph (b)(37) of this section without po- the following proportions: 1 part phos- tassium bromide shall provide, when phoric acid to 0.25 octenyl succinic acid ready to use, at least 100 parts per mil- to 0.18 part N,N-dimethyloctanamine to lion and not more than 200 parts per 0.062 part of a mixture of n-carboxylic million of available halogen deter- acids (C6–C12, consisting of not less than mined as available chlorine; at least 56 percent octanoic acid and not less 2,958 parts per million and not more than 40 percent decanoic acid). than 5,916 parts per million of tri- (35) Solutions identified in paragraph sodium phosphate; at least 1 part per (b)(40) of this section shall provide million and not more than 3 parts per when ready for use not less than 12.5 million of sodium lauryl sulfate; and at parts per million and not more than least 0.3 part per million and not more 25.0 parts per million of titratable io- than 0.7 part per million on potassium dine; and not less than 2.7 parts per permanganate. million and not more than 5.5 parts per (ii) The solution identified in para- million of dodecylbenzene sulfonic 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(C - not more than 0.3 part per million of 12 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 parts per million of hydrogen peroxide; dextrin, or a combination of starch and not less than 200 parts per million and dextrin. not more than 315 parts per million of (37)(i) The solution identified in para- peroxyacetic acid; not less than 200 graph (b)(42) of this section not con- parts per million and not more than 340 taining sulfuric acid shall provide when parts per million of acetic acid; not ready for use not less than 45 parts per less than 10 parts per million and not million and not more than 90 parts per more than 20 parts per million of sul- million of decanoic acid; and all com- furic acid; and not less than 0.75 parts ponents shall be present in the fol- per million and not more than 1.2 parts lowing proportions (weight/weight (w/ per million of 2,6-pyridinedicarboxylic w)): 1 part decanoic acid to 1 part nona- acid. noic acid to 9.5 parts phosphoric acid to
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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 pro- of 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),’’ parts per million and not more than 34 dated June 11, 1987, which is incor- parts per million of 1- porated by reference in accordance hydroxyethylidene-1,1-diphosphonic with 5 U.S.C. 552(a) and 1 CFR part 51. acid; and at least 36 parts per million Copies of this method are available and not more than 109 parts per million from the Division of Petition Control, of sodium 1-octanesulfonate. Center for Food Safety and Applied Nu- (ii) The solution identified in para- trition (HFS–215), Food and Drug Ad- graph (b)(45) of this section, when used ministration, 200 C St. SW., Wash- on food-contact equipment and utensils ington, DC 20204, and may be examined in warewashing machines, including at the Center for Food Safety and Ap- warewashing machines in public eating plied Nutrition’s Library, Food and places, at temperatures no less than 120 Drug Administration, 200 C St. SW.,
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rm. 3321, Washington, DC, or at the Of- Finding Aids section of the printed volume fice of the Federal Register, 800 North and on GPO Access. Capitol St. NW., suite 700, Washington, DC; at least 380 parts per million and Subpart C—Antioxidants and not more than 760 parts per million of Stabilizers sodium gluconate; and at least 960 parts per million and not more than § 178.2010 Antioxidants and/or stabi- 1,920 parts per million of sodium mono- lizers for polymers. and The substances listed in paragraph didodecylphenoxybenzenedisulfonate. (b) of this section may be safely used as Other components listed under para- antioxidants and/or stabilizers in poly- graph (b)(46) of this section shall be mers used in the manufacture of arti- used in the minimum amount nec- cles or components of articles intended essary to produce the intended effect. for use in producing, manufacturing, (d) Sanitizing agents for use in ac- packing, processing, preparing, treat- cordance with this section will bear la- ing, packaging, transporting, or hold- beling meeting the requirements of the ing food, subject to the provisions of Federal Insecticide, Fungicide, and this section: Rodenticide Act. (a) The quantity used shall not ex- [42 FR 14609, Mar. 16, 1977] ceed the amount reasonably required EDITORIAL NOTE: For FEDERAL REGISTER ci- to accomplish the intended technical tations affecting § 178.1010, see the List of effect. CFR Sections Affected, which appears in 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 5.4Ð5.6 weight percent. 2. At levels not to exceed 1.35 percent by weight of natural rubber, buta- 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 com- plying with ¤ 175.300, ¤ 176.170, or ¤ 175.320 of this chapter. The aver- age thickness of such coatings and closure-sealing gaskets shall not ex- ceed 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. 164907Ð73Ð7).. ¤ 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. 203742Ð97Ð6).. 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-methyl- phenyl]ester (CAS Reg. No. 57569Ð40Ð1). 2-(2H-Benzotriazol-2-yl)-4,6-bis(1-methyl-1- For use only: phenylethyl)phenol (CAS Reg. No. 70321Ð86Ð7). 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. 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. 3147Ð resins complying with ¤ 177.1580 of this chapter: Provided, That the fin- 75Ð9). ished resins contact food only under conditions of use E, F, and G de- scribed in table 2 of ¤ 176.170(c) of this chapter.
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Substances Limitations
2-[4,6-Bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5- For use only: (octyloxy)phenol (CAS Reg. No. 2725Ð22Ð6).. 1. At levels not to exceed 0.3 percent by weight of olefin polymers com- plying with ¤ 177.1520(c) of this chapter in contact with food types I, II, IVÐB, VI, VIIÐB, 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, IVÐA, V, VIIÐA, 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, IVÐA, V, VIIÐA, 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, IVÐA, V, VIIÐA, and IX hold a minimum of 5 gallons (18.9 liters) of food. β, 3(or 4)-Bis(octadecylthio)cyclohexylethane (CAS For use only: Reg. No. 37625Ð75Ð5); 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. 52829Ð07Ð9). 1. In adhesives complying with ¤ 175.105 of this chapter. 2. At levels not to exceed 0.1 percent by weight of pressure-sensitive adhe- sives 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. 145650Ð60Ð8). 1. At levels not to exceed 0.3 percent by weight of olefin polymers com- plying 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 de- scribed 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 poly- mers 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. 32687Ð78Ð8). 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 co- polymers complying with ¤ 177.2470 of this chapter and of polyoxymethylene homopolymers complying with ¤ 177.2480 of this chap- ter. 2,6-Bis(1-methylheptadecyl)-p-cresol ...... For use only at levels not exceeding 0.3 percent by weight of olefin poly- mers 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. 154862Ð43Ð8), 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. 122Ð20Ð3). 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. 181314Ð48Ð7). 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, IVÐB, VIÐA, VIÐB, VIIÐB, 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, IVÐA, V, VIÐC, VIIÐA, 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, IVÐA, V, VIÐC, VIIÐA, and IX, and under conditions of use B through H described in Table 2 of ¤ 176.170(c) of this chapter; provided that the fin- ished food-contact articles have a volume of at least 18.9 liters (5 gal- lons). 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 poly- mers may only be used in contact with food of the types identified in ¤ 176.170(c) of this chapter, Table 1, under Categories III, IVÐA, V, VIÐC, VIIÐA, 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 thick- ness 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. 90498Ð90Ð1). used in contact with food only under conditions of use D through H de- scribed 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 com- plying 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, IVÐB, VIÐA, VIÐB, VIÐC, VIIÐB, 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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4-[[4,6-Bis(octylthio)-s-triazin-2-yl]amino]-2,6-di- For use only: tert-butylphenol (CAS Reg. No. 991Ð84Ð4). 1. At levels not to exceed 0.5 percent by weight: in styrene block copoly- mers complying with ¤ 177.1810 of this chapter; in rosins and rosin de- rivatives complying with ¤ 175.300(b)(3)(v) of this chapter; in can end ce- ment 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 deriva- tives 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 gas- kets 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-sen- sitive adhesives complying with ¤ 175.125 of this chapter; and as pro- vided in ¤ 177.2600 of this chapter. 4,4′-Bis(α,α-dimethylbenzyl)diphenylamine (CAS For use at levels not to exceed 0.3 percent by weight of polypropylene Reg. No. 10081Ð67Ð1). 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. 10043Ð35Ð3) ...... 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. 1,3ÐButanediol. 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, IVÐB, VIÐA, VIÐB, VIIÐB, 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, IVÐA, V, VIÐC, VIIÐA, 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 13Ð25 percent by weight of butylated tions described in ¤ 176.170(c) of this chapter, table 2, under conditions m- and p-cresols, 26Ð38 percent by weight of of use C through G. styrenated m- and p-cresols, 37Ð49 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 1.5550Ð1.5650, as determined by ASTM method D1218Ð82, ‘‘Standard Test Meth- od for Refractive Index and Refractive Disper- sion of Hydrocarbon Liquids,’’ which is incor- porated 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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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 3.8Ð4.0 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 com- plying with ¤ 175.300, ¤ 175.320, or ¤ 176.170 of this chapter. The aver- age thickness of such coatings and closure-sealing gaskets shall not ex- ceed 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 137Ð 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 con- tact food only of the types identified in ¤ 176.170(c) of this chapter, table 1, under Categories I, II, VIÐB, 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- 32509Ð66Ð3). 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, IVÐA, V, VIIÐA, 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 com- plying 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 com- plying with ¤ 177.1520(c) of this chapter, items 2.1, 2.2, 3.1, and 3.2. Calcium benzoate..
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Calcium bis[monoethyl(3,5-di-tert-butyl-4-hydroxy- For use only: benzyl)phosphonate] (CAS Reg. No. 65140Ð91Ð 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 adhe- sives complying with ¤ 175.125 of this chapter. 5. At levels not to exceed 0.5 percent by weight of rosins and rosin deriva- tives 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 formu- lations 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 for- mulations complying with ¤ 175.300(b)(3)(xxxii) of this chapter. 8. At levels not to exceed 0.5 percent by weight of petroleum alicyclic hy- drocarbon 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 deriva- tives complying with ¤ 176.170(a)(5) of this chapter; and petroleum alicy- clic 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 arti- cle 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 com- plying 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. 867Ð13Ð0). polymers complying with ¤ 177.1630 of this chapter. Cerium stereate (CAS Reg. No. 10119Ð53Ð6) ...... For use only at levels not to exceed 0.5 percent by weight in rigid and semirigid vinyl chloride homoÐ and copolymer articles modified in accord- ance with ¤ 178.3790(b)(1) of this chapter that contact food under condi- tions of use B through H described in table 2 of ¤ 176.170(c) of this chap- ter. 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 tempera- tures 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 tempera- tures 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. 3806Ð34Ð6); 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. 3806Ð34Ð6) (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. 122Ð20Ð3)); 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 com- plying 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 rub- ber 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 poly- mers 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°Ð62 °C as determined by ASTM method the finished food-contact article shall not exceed a total of 0.5 milligram E324Ð79, ‘‘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 saponifica- tion value in the range 176Ð183 as determined by ASTM method D1962Ð67 (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. DidodecylÐ 1,4ÐdihydroÐ2,6ÐdimethylÐ3,5Ð For use only at levels not to exceed 0.3 percenmt by weight in rigid poly- pyridinedicarboxylate (CAS Reg. No. 36265Ð41Ð 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(α-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. 1817Ð68Ð1]. 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 fin- ished 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. 134701Ð20Ð5). 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 chlo- ride, 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. 65447Ð77Ð0). 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 condi- tions of use B through H described in table 2 of ¤ 176.170(c) of this chap- ter.
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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 54849Ð38Ð6) 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, 57583Ð34Ð3) 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. 26636Ð01Ð1) or dimethyltin bis(2Ð chapter at temperatures not to exceed 88 °C (190 °F). ethylhexylmercaptoacetate) (CAS Reg. No. 57583Ð35Ð4), 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°Ð52 °C as determined by ASTM method tives limitations prescribed in ¤ 176.170(c) of this chapter. E324Ð79, ‘‘Standard Test Method for Relative Initial and Final Melting Points and the Melting Range of Organic Chemicals,’’ and a saponifica- tion equivalent in the range 280Ð290 as deter- mined by ASTM method D1962Ð67 (Re- approved 1979), ‘‘Standard Test Method for Sa- ponification Value of Drying Oils, Fatty Acids, and Polymerized Fatty Acids,’’ which are incor- porated 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. 10039Ð33Ð5] 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 specifica- tions 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 ace- tate copolymers containing not more than 20 molar percent of vinyl ace- tate. 2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5- For use only hexyloxy)phenol (CAS Reg. No. 147315Ð50Ð2). 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 ex- ceeding 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 thick- ness 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 com- plying 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. 178358Ð 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- 58Ð2) 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 min- imum phosphorus content of 5.0 percent. Di-tert-butylphenyl phosphonite condensation For use only: product with biphenyl (CAS Reg. No. 119345Ð 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- 01Ð6) 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 per- cent by weight of rubberÐmodified polystyrene complying with ¤ 177.1640 of this chapter. 4. At levels not to exceed 0.15 percent by weight of olefin polymers com- plying 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 ar- ticles 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. 4221Ð80Ð1). 1. At levels not to exceed 0.6 percent by weight of olefin polymers com- plying with ¤ 177.1520(c) of this chapter, item 1.1: (1) when used in sin- gle-use articles that contact food of types I, II, IVÐB, VIÐA, VIÐB, VIIÐB, 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, IVÐB, VIÐA, VIÐ B, VIIÐB, 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 chap- ter. 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. 123968Ð25Ð2). 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 poly- mers 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″′Ð1,2ÐEthanediylbis[NÐ[3Ð[[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, IVÐA, V, VIÐC, VIIÐA, and IX as described in table 1 of amine] (CAS Reg. No. 106990Ð43Ð6). ¤ 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 com- plying with ¤ 177.1520(c) of this chapter. The finished polymers may only be used in contact with food of the Types I, II, IVÐB, VIÐA, VIÐB, VIIÐB, 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 36443Ð68Ð2). 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 co- polymers used in accordance with ¤ 177.2470 of this chapter. The fin- ished articles shall not be used for foods containing more than 15 per- cent 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 per- cent alcohol. 5. At levels not to exceed 0.2 percent by weight of rigid vinyl chloride plas- tics prepared from vinyl chloride homopolymers and/or vinly chloride co- polymers used in accordance with a prior sanction or applicable regula- tions in parts 175, 176, and 177 of this chapter. The vinyl chloride co- polymers 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. 35958Ð30Ð6). 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- plying 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 com- plying with ¤ 177.1520(c) of this chapter, item 2.1, 2.2, or 2.3. The fin- ished 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 com- plying 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 com- plying 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 condi- tions 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 poly- vinyl 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 acrylo- nitrile 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 poly- styrene 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. 118337Ð09Ð0). 2. In all polymers used in contact with food of types I, II, IVÐB, VIÐA, VIÐB, VIIÐB, 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 per- cent 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, IVÐA, V, VIIÐA, 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 poly- mer units derived from propylene, in contact with food of types III, IVÐA, V, VIIÐA, 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 per- cent 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, IVÐA, V, VIIÐA, and IX, under con- ditions 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 poly- mers; 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, IVÐA, V, VIIÐA, 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 poly- mer; 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, IVÐA, V, VIIÐA, 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 per- cent 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, IVÐ A, V, VIIÐA, 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 sur- face 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, IVÐA, V, VIÐC, VIIÐA, 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, IVÐA, V, VIIÐA, and IX, and limited to levels not to exceed 0.1 percent by weight of the polymers; pro- vided 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. 67845Ð93Ð6). 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 adhe- sives complying with ¤ 175.125 of this chapter. 4. At levels not to exceed 1 percent by weight in can end cement formula- tions complying with ¤ 175.300(b)(3)(xxxi) of this chapter. 5. At levels not to exceed 1 percent by weight in side seam cement formu- lations complying with ¤ 175.300(b)(3)(xxxii) of this chapter. 6. At levels not to exceed 1 percent by weight in petroleum alicyclic hydro- carbon 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 hydro- carbon 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 au- thorized 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 23128Ð74Ð7). 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 VIÐA and VIÐC. 2. At levels not to exceed 0.75 percent by weight of nylon 12 resins com- plying 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 VIÐA and VIÐC. 3. At levels not to exceed 0.6 percent by weight of polyester resins com- plying 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 ar- ticles complying with ¤ 177.2600 of this chapter. 6. At levels not to exceed 0.5 percent by weight of polyoxymethylene co- polymer 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. 1,6ÐHexanediamine, 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. 193098Ð40Ð7). 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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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. 192268Ð64Ð7). of the types identified in ¤ 176.170(c) of this chapter, table 1, under cat- egories I, II, IVÐB, VIÐA, VIÐB, VIIÐB, 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 cat- egories III, IVÐA, V, VIÐC, VIIÐA, 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 chap- ter, table 1, under categories I, II, IVÐB, VIÐA, VIÐB, VIIÐB, 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 chap- ter, table 1, under categories III, IVÐA, V, VIÐC, VIIÐA, 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, IVÐB, VIÐA, VIÐB, VIIÐB, 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, IVÐA, V, VIÐC, VIIÐA, 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- 330:59Ð05Ð1. 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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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° Ð132 °C (258.8° Ð269.6 °F) (CAS Reg. No. chapter. 2440Ð22Ð4). 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 rub- ber-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 de- rived 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, VIÐA, VIÐ 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 condi- tions of use D through G described in table 2, ¤ 176.170(c) of this chap- ter. 2-Hydroxy-4-n-octoxy-benzophenone ...... For use only at levels not to exceed 0.5 percent by weight of olefin poly- mers 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 con- tacts 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 5.2Ð5.6 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 copoly- mers 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. 110553Ð27Ð0). 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 adhe- sives complying with ¤ 175.125 of this chapter petrolium alicyclic hydro- carbon resins complying with ¤ 176.170 of this chapter, resins and poly- mers 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 prod- ucts complying with ¤ 177.2600 of this chapter. 5. At levels not to exceed 0.1 percent by weight of petroleum alicyclic hy- drocarbon resins complying with ¤ 175.320 of this chapter; rubber-modi- fied 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, IVÐB, VI, VIIÐB, and VIII described in table 1, ¤ 176.170(c) of this chap- ter, only under conditions of use C through H described in table 2, ¤ 176.170(c) of this chapter.
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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. 126050Ð propylene complying with ¤ 177.1520 of this chapter. The finished poly- 54Ð2). 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, IVÐB, VIÐB, VIIÐB, 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, IVÐA, V, VIÐA, VIÐC, VIIÐA, 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 chap- ter. 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 com- plying 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 iden- tified 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 copoly- mer 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. 61167Ð58Ð6). 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, VIÐB, 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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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. 68442Ð12Ð6); 2. Fatty acids, tall oil, 2-mercaptoethyl esters, reaction products with dichlorodimethylstannane, 2-mercaptoethyl decanoate, 2-mercaptoethyl octanoate, so- dium sulfide, and trichloromethylstannane (CAS Reg. No. 151436Ð98Ð5); or 3. Fatty acids, tall oil, 2-mercaptoethyl esters, reaction products with dichlorodimethylstannane, sodium sulfide, and trichloromethylstannane (CAS Reg. No. 201687Ð57Ð2);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 fol- lowing optional substances: 1.1a 2-Mercaptoethyl oleate (CAS Reg. No. 59118Ð78Ð4), 1.1b 2-Mercaptoethyl tallate (CAS Reg. No. 68440Ð24Ð4), 1.1c 2-Mercaptoethyl octanoate (CAS Reg. No. 57813Ð59Ð9), 1.1d 2-Mercaptoethyl decanoate (CAS Reg. No. 68928Ð33Ð6), alone or in combination; not to exceed 40 percent by weight of the stabilizer formulation; 2.1 2-Mercaptoethanol (CAS Reg. No. 60Ð24Ð 2): Not to exceed 2 percent by weight of the stabilizer formulation. 3.1 Mineral oil (CAS Reg. No. 8012Ð95Ð1): Not to exceed 40 percent by weight of the stabilizer formulation. 4.1 Butylated hydroxytoluene (CAS Reg. No. 128Ð37Ð0): 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. 51733Ð For use only at levels not to exceed 1.5 percent by weight of 10Ð9), weight ratio 6/1. polyoxymethylene homopolymer as provided in ¤ 177.2480(b)(1).
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Octadecyl 3,5-di-tert-butyl-4- For use only: hydroxyhydrocinnamate (CAS Reg. No. 2082Ð 1. At levels not exceeding 0.25 percent by weight of olefin polymers com- 79Ð3). 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 rub- ber-modified polystyrene polymers complying with ¤ 177.1640 of this chapter, except that the finished basic rubber-modified polystyrene poly- mers in contact with fatty foods shall contain not less than 85 weight per- cent 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 com- plying 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, IVÐB, VI, VII, VIII, and IX; (b) item 3.5, Provided, That the fin- ished copolymer contacts non-fatty foods only of types identified in ¤ 176.170(c) of this chapter, table 1, under Categories I, II, IVÐB, VI, VIIÐ 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-sty- rene 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 con- tact food only of the types identified in ¤ 176.170(c) of this chapter, table 1, under Categories I, II, IVÐB, VI, VIIÐB, 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 ap- plicable 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 ar- ticle complying with ¤ 177.2600 of this chapter.
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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. 202483Ð55Ð4). 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, pro- vided 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, IVÐA, V, VIIÐ 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 com- plying 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 com- plying 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 con- ditions 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 capac- ity of at least 18.9 liters (5 gallons) when in contact with food of types III, IVÐA, V, VIIÐA, 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 com- plying 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 con- tact 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-con- tact 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, IVÐB, VI, and VIII, described in Table 1 of ¤ 176.170 of this chapter with no restric- tions 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, IVÐB, VIIÐB and VIII de- scribed 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, IVÐA, V, VI, VIIÐA, and IX described in table 1 of ¤ 176.170(c) of this chapter, under conditions of use D through H de- scribed in table 2 of ¤ 176.170(c) of this chapter. 2. At levels not to exceed 0.075 percent by weight of high-density poly- ethylene 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, IVÐB, VIIÐB 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, IVÐA, V, VI, VIIÐA and IX described in table 1 of ¤ 176.170(c) of this chapter, under condi- tions 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- 70331Ð94Ð1). modified polystyrene complying with ¤ 177.1640 of this chapter. 2. At levels not to exceed 0.5 percent by weight of olefin polymers com- plying 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 com- plying 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, IVÐB, VI, VIIÐB and VIII de- scribed in table 1 of ¤ 176.170(c) of this chapter. 4. At levels not to exceed 0.1 percent by weight of olefin polymers com- plying 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, IVÐA, V, VIIÐA, and IX described in table 1 of ¤ 176.170(c) of this chapter; except that olefin copolymers com- plying with items 3.1 and 3.2 where the majority of polymer units are de- rived 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 com- plying with item 3.4 of ¤ 177.1520(c) of this chapter, that contact food Types III, VIIÐA, and IX described in table 1 of ¤ 176.170(c) of this chap- ter; except that olefin copolymers complying with item 3.4 where the ma- jority of the polymer units are derived from propylene may contain the ad- ditive at levels not to exceed 0.5 percent by weight.
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Pentaerythritol and its stearate ester ...... For use only in rigid polyvinyl chloride and/or in rigid vinyl chloride copoly- mers 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 poly- mers. 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. 68411Ð adhesives complying with ¤ 175.125 of this chapter. 46Ð1). Phosphoric acid triesters with triethylene glycol At levels not to exceed 0.1 percent by weight of polyethylene phthalate (CAS Reg. No. 64502Ð13Ð2). polymers complying with ¤ 177.1630 of this chapter, such that the poly- mers contact foods only of Type VIÐB 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- 161717Ð32Ð4), 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. 122Ð20Ð3). gram per cubic centimeter), and items 3.1 or 3.2, provided that the fin- ished polymer contacts foods of types I, II, and VIÐB 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 com- plying with ¤ 177.1520(c) of this chapter, items 1.1, 1.2, or 1.3, that con- tact food of types III, IV, V, VIÐA, VIÐC, 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 com- plying 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, VIÐA, VIÐC, 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 com- plying 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, VIÐA, VIÐC, 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, 26741Ð53Ð7) 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. 122Ð20Ð3). ¤ 176.170(c) of this chapter. Olefin polymers that contain more than 50 weight-percent of polymer units derived from ethylene shall have a den- sity 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. 80693Ð00Ð1). 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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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/ 26741Ð53Ð7). 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 de- scribed 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 de- scribed 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 com- plying 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 thick- ness of such polymers intended for use in contact with food types V and VIIÐA 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 1,800Ð2,200, 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 ride resin where such resin constitutes not less than 98.7 percent of a averages 1.5Ð2) and produced so as to meet finished semirigid or rigid polyvinyl chloride food-contact surface, pro- the following specifications: Softening point, vided that the finished food-contact article is employed only to package 130Ð145 °C; volatile components at 150 °C, meat, cheese, and food Types I, VIII, and IX as described in table 1 of less than 1.0 percent; sulphur (sulfide) content ¤ 176.170(c) of this chapter. The finished food-contact article containing in the range 20.5Ð22.0 percent; tin content in this stabilizer, when extracted with refined cottonseed oil at 120 °F for 48 the range 52.0Ð53.2 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 ethylene Reg. No. 82451Ð48Ð7). 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 poly- mers are to contact food only under conditions of use D, E, F, and G de- scribed in table 2 of ¤ 176.170(c) of this chapter. 2. At levels not to exceed 0.3 percent by weight of olefin polymers com- plying 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 con- ditions 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 70624Ð18Ð9). 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, IVÐA, V, VIIÐA, 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. 136504Ð96Ð6). 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 condi- tions 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, IVÐA, V, VIIÐA, 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. 69851Ð61Ð2). 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. 182635Ð chapter, items 1.1a, 1.1b, 1.2, and 1.3, under conditions of use D, E, F, 99Ð0). and G, as described in Table 2 of ¤ 176.170 of this chapter. Stearoylbenzoylmethane (CAS Reg. No. 58446Ð For use only at levels not to exceed 0.5 percent by weight of vinyl chloride 52Ð9) consisting of a mixture of βÐdiketones 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. 68442Ð For use only in adhesives complying with ¤ 175.105 of this chapter and in 68Ð2). 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- 20336Ð96Ð3). 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 fin- ished polymers may only be used in contact with food of Types I, II, IVÐ B, VIÐB, VIIÐB, 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, IVÐA, V, VIÐA, VIÐC, VIIÐA, 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, IVÐB, VIÐA, VIÐB, VIIÐB, and VIII described in table 1, yl]oxy]ethyl]ethanamine (CAS Reg. No. 80410Ð of ¤ 176.170(c) of this chapter, under conditions of use B through H de- 33Ð9). scribed in table 2 of ¤ 176.170(c) of this chapter and food only of Types III, IVÐA, V, VIÐC, VIIÐA, 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: hydroxyhydro- cinnamate)] methane (CAS Reg. 1. At levels not to exceed 0.5 percent by weight of all polymers used as in- No. 6683Ð19Ð8). direct additives in food packaging, except as specified below. 2. At levels not to exceed 0.1 percent by weight of petroleum wax or syn- thetic 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 chap- ter. (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 chap- ter. (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 fin- ished polyethylene contacts food only of the types identified in ¤ 176.170(c) of this chapter, table 1, under Categories I, II, VIÐB, 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 adhe- sives complying with ¤ 175.125 of this chapter, petroleum alicyclic hydro- carbon resins complying with ¤ 176.170 of this chapter, resins and poly- mers complying with ¤ 176.180 of this chapter, closures with sealing gas- kets complying with ¤ 177.1210 of this chapter, and finished rubber prod- ucts 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. 1709Ð 1. At levels not to exceed 0.5 percent by weight of polymers except nylon 70Ð2). 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. 64253Ð30Ð1). 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- 27676Ð62Ð6). 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 com- plying 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 com- plying with ¤ 177.1520(c) of this chapter, items 3.1 and 3.2, and also con- taining not less than 85 weight percent of polymer units derived from pro- pylene. 6. At levels not to exceed 0.2 percent by weight of olefin polymers com- plying 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 de- scribed 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 com- plying 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. 40601Ð76Ð1]. 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, pro- vided that the finished polystyrene and rubber-modified polystyrene con- tact food only under the conditions described in ¤ 176.170(c) of this chap- ter, 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. 31570Ð04Ð4). 1. At levels not to exceed 0.5 percent by weight of elastomers used in rub- ber 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 con- tacts 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 rub- ber-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 com- plying 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 com- plying 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 cen- timeter 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 lim- ited 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 thick- ness 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 com- plying with ¤ 177.1520(c) of this chapter, item 4. The finished polymers having a thickness greater than 0.051 millimeter (0.002 inch), shall con- tact 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 ad- hesives complying with ¤ 175.125 of this chapter. 13. At levels not to exceed 0.5 percent by weight of can end cement formu- lations 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 for- mulations complying with ¤ 175.300(b)(3) (xxxii) of this chapter. 15. At levels not to exceed 0.5 percent by weight of petroleum alicyclic hy- drocarbon resins complying with ¤ 175.320(b)(3) of this chapter. 16. At levels not to exceed 0.5 percent by weight of petroleum alicyclic hy- drocarbon 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 deriva- tives 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 com- plying with ¤ 178.3850. 22. At levels not to exceed 0.5 percent by weight of olefin copolymers com- plying 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 chap- ter: Provided, that the finished polymer contacts food only under condi- tions of use B through H described in table 2 of ¤ 176.170(c) of this chap- ter.
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Substances Limitations
Tris(2-methyl-4-hydroxy-5-tert-butylphenyl)butane For use only: (CAS Reg. No. 1843Ð03Ð4). 1. At levels not to exceed 0.25 percent by weight of polymers used as pro- vided 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, IVÐB, VIÐB, VIIÐB, and VIII described in table 1 of ¤ 176.170(c) of this chapter: Olefin poly- mers 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 poly- mers; 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, IVÐA, V, VIÐA, VIÐC, VIIÐA, 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 modi- fied 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. 136Ð For use only: 23Ð2). 1. At levels not to exceed 0.2 percent by weight of isobutyleneisoprene co- polymers 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 poly- mers 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 copoly- mers 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- safety used alone or in combination, at butylphenol. levels not to exceed a total of 3 parts 4-Hydroxymethyl-2,6-di-tert-butyl- per hundred of resin, as stabilizers in phenol may be safely used as an anti- vinyl chloride homopolymers and co- oxidant in articles intended for use in polymers complying with the provi- contact with food, in accordance with sions of § 177.1950 or § 177.1980 of this the following prescribed conditions: chapter and that are identified for use (a) The additive has a solidification in contact with food of types I, II, III, point of 140°–141 °C. IV (except liquid milk), V, VI (except (b) The concentration of the additive malt beverages and carbonated non- and any other permitted antioxidants alcoholic beverages), VII, VIII, and IX in the finished food-contact article described in table 1 of § 176.170(c) of this does not exceed a total of 0.5 milligram chapter, except for the organotin per square inch of food-contact surface. chemical identified in paragraph (a)(3) of this section, which may be used in § 178.2650 Organotin stabilizers in contact with food of types I through IX vinyl chloride plastics. at temperatures not exceeding 75 °C The organotin chemicals identified in (167 °F), and further that the organotin paragraph (a) of this section may be chemicals identified in paragraphs (a)
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(5) and (6) of this section may be used weight of tin (Sn) and having 8.0 to 8.6 in contact with food of types I through percent by weight of mercapto sulfur. IX at temperatures not exceeding 66 °C It is made from a mixture of di(n- (150 °F), conditions of use D through G octyl)tin dichloride and (n-octyl)tin described in table 2 of § 176.170(c) of this trichloride which has an organotin chapter, and further that dodecyltin composition that is not less than 95 chemicals identified in paragraph (a)(7) percent by weight di(n-octyl)tin dichlo- of this section which may be used in ride/(n-octyl)tin trichloride, and not contact with food of types I, II, III, IV more than 1.5 percent by weight of (except liquid milk), V, VI (except malt tri(n-octyl)tin chloride. The alkyl rad- beverages and carbonated nonalcoholic ical in the mercaptoacetate is derived beverages), VII, VIII, and IX described from a mixture of saturated n-alcohols in table 1 of § 176.170(c) of this chapter which has a composition that is not at temperatures not exceeding 71 °C less than 50 percent by weight (160 °F), in accordance with the fol- tetradecyl alcohol, and that is not lowing prescribed conditions: 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 is derived from oxo process primary between 2 and 4 inclusive), having 25.2 octyl alcohols. The bis(beta- to 26.6 percent by weight of tin (Sn) carbobutoxyethyl)tin dichloride has an and having a saponification number of organotin composition that is not less 225 to 255. It is made from di(n- than 95 percent by weight of bis(beta- octyl)tin dichloride or di(n-octyl)tin carbobutoxyethyl)tin dichloride and oxide meeting the specifications pre- not more than 5 percent by weight of scribed for di(n-octyl) tin dichloride or bis(beta-carbobutoxyethyltin tri- di(n-octyl) tin oxide in paragraph (a)(1) chloride. The triestertin chloride con- of this section. tent of bis(beta-carbobutoxyethyltin) (3) C10-16-Alkyl mercaptoacetates re- dichloride shall not exceed 0.02 percent. action products with p dichlorodioctylstannane and (6) Beta-carbobutoxyethyltin trichlorooctylstannane (CAS Reg. No. tris(isooctylmercaptoacetate) (CAS 83447–69–2) is an organotin chemical Reg. No. 63438–80–2) is an estertin mixture having 10.8 to 11.8 percent by chemical having 13.0 to 14.0 percent by
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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, 200 C St., SW., Wash- tris(isooctylmercaptoacetate) (CAS ington, DC 20204, or available for in- Reg. No. 67649–65–4) and 40 to 50 percent spection 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 cover at least three equilibrium peri- with foods only of Types II, V, VI-A odic determinations, as follows: (except malt beverages), and VI-C may (i) The exposure time for the first de- be end-tested with food-simulating sol- termination shall be at least 72 hours vents, under conditions of time and for aqueous solvents, and at least 6 temperature, as specified below, where- hours for heptane. by such tests shall yield the octyltin
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residues cited in paragraph (b)(1) of List of substances Limitations this section not in excess of 0.5 ppm: Toluene ...... For use only as a blowing agent ad- juvant in polystyrene at a level not Tem- perature to exceed 0.35 percent by weight Food-simulating solvent Time (degrees of finished foamed polystyrene. (hours) Fahr- enheit) [47 FR 22090, May 21, 1982, as amended at 58 Type II ...... Acetic acid, 3 pct ...... 48 135 FR 64895, Dec. 10, 1993] Type V ...... Heptane ...... 2 100 Type VIÐA ... Ethyl alcohol, 8 pct ...... 24 120 § 178.3120 Animal glue. Type VIÐC ... Ethyl alcohol, 50 per- 24 120 cent. Animal glue may be safely used as a component of articles intended for use [42 FR 14609, Mar. 15, 1977, as amended at 47 in producing, manufacturing, packing, FR 11847, Mar. 19, 1982; 48 FR 7170, Feb. 18, processing, preparing, treating, pack- 1983; 48 FR 42972, Sept. 21, 1983; 48 FR 51612, aging, transporting, or holding food, Nov. 10, 1983; 49 FR 8432, Mar. 7, 1984; 50 FR subject to the provisions of this sec- 62, Jan. 2, 1985; 50 FR 3510, Jan. 25, 1985; 50 FR tion. 37998, Sept. 19, 1985; 50 FR 47212, Nov. 15, 1985; (a) Animal glue consists of the pro- 54 FR 24898, June 12, 1989] teinaceous extractives obtained from hides, bones, and other collagen-rich Subpart D—Certain Adjuvants and substances of animal origin (excluding Production Aids diseased or rotted animals), to which may be added other optional adjuvant § 178.3010 Adjuvant substances used in substances required in its production the manufacture of foamed plastics. or added to impart desired properties. The following substances may be (b) The quantity of any substance safely used as adjuvants in the manu- employed in the production of animal facture of foamed plastics intended for glue does not exceed the amount rea- use in contact with food, subject to any sonably required to accomplish the in- prescribed limitations: tended physical or technical effect nor any limitation further provided. List of substances Limitations (c) Any substance employed in the Azodicarbonamide ..... For use as a blowing agent in pol- production of animal glue and which is yethylene complying with item 2.1 the subject of a regulation in parts 174, in ¤ 177.1520(c) of this chapter at 175, 176, 177, 178 and § 179.45 of this chap- a level not to exceed 5 percent by ter conforms with any specification in weight of finished foamed poly- ethylene. such regulation. 1,1-Difluoroethane For use as a blowing agent in poly- (d) Optional adjuvant substances em- (CAS Reg. No. 75Ð styrene. ployed in the production of animal glue 37Ð6). Isopentane ...... For use as a blowing agent in poly- include: styrene. (1) Substances generally recognized n-Pentane ...... Do. as safe in food. 1,1,2,2-Tetra- For use only as a blowing agent ad- (2) Substances subject to prior sanc- chloroethylene. juvant in polystyrene at a level not to exceed 0.3 percent by weight of tion or approval for use in animal glue finished foamed polystyrene in- and used in accordance with such sanc- tended for use in contact with food tion or approval. only of the types identified in (3) Substances identified in this para- ¤ 176.170(c) of this chapter, table 1, under Categories I, II, VI, and graph (d)(3) and subject to such limita- VIII. tions as are provided:
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. 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.
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List of substances Limitations
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 sub- stance 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. 55799Ð dry foods. finished form of the substance or arti- 16Ð1). 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 ex- ceed 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 pack- aging 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 copoly- mer 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 ace- tate 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 exceed- ing 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 C10ÐC18 with not less than 50 per- 1. As antistatic agents at levels not to exceed 0.1 percent by cent C14ÐC16). 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 de- scribed 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 com- plying 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. 11121Ð16Ð 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 fin- ished 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 poly- propylene 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 fin- ished 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: 70955Ð14Ð5). 1. As an antistatic agent at levels not to exceed 0.2 percent by weight in molded or extruded high-density polyethylene (hav- ing 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, VIÐB, VIIÐB, 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, VIIÐA, 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: (C14–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 co- polymer coatings complying with ¤ 175.320, ¤ 177.1200, or ¤ 177.1630 of this chapter, provided that such coatings con- tact 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- cC; 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, VIÐB, 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 chap- ter. 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. 10213Ð78Ð2, 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. 66810Ð88Ð6, and N,N-Bis(2-hydroxy- Types I, II, III, IV, V, VIÐB, 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. 24170Ð14Ð7, 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 hydrox- ide, such that the final product has: A nitrogen content of 3.3Ð3.8 percent; a melting point of 42°Ð50 °C; and a pH of 10.0Ð11.5 in a 1 percent by weight aqueous solution. α-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-α-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. 66822Ð60Ð4). ¤ 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. 52497Ð24Ð2), (octadecylimino) diethyl- product of film thickness in microns times the weight percent ene distearate (CAS Reg. No. 94945Ð28Ð5), and octadecyl additive does not exceed 16, in polypropylene films com- bis(hydroxyethyl)amine (CAS Reg. No. 10213Ð78Ð2), 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 (HFSÐ200), Food and Drug Ad- ministration, 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 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. (b) The packaging container which Myristo chromic chloride complex has its closure area treated with the and stearato chromic chloride complex release agent shall have a capacity of may be safely used as release agents in not less than 120 grams of food per the closure area of packaging con- square inch of such treated closure tainers intended for use in producing, area. manufacturing, packing, processing, preparing, treating, packaging, trans- § 178.3295 Clarifying agents for poly- porting, or holding food, subject to the mers. provisions of this section: Clarifying agents may be safely used (a) The quantity used shall not ex- in polymers that are articles or compo- ceed that reasonably required to ac- nents of articles intended for use in complish the intended technical effect contact with food, subject to the provi- sions of this section:
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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. 151841Ð65Ð5). 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 chap- ter 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. 79072Ð96Ð1) ... 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. 54686Ð97Ð4) ...... 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 copoly- mers complying with ¤ 177.1520(c) of this chapter, item 3.1 (containing at least 85 weight percent of polymer units de- rived 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. 32647Ð67Ð9) 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. 135861Ð56Ð2) 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 con- tact with food under conditions of use A through H described in table 2 of ¤ 176.170(c) of this chapter. Polyvinylcyclohexane (CAS Reg. No. 25498Ð06Ð0) ...... For use only as a clarfiying agent for polypropylene complying with ¤ 177.1520(c) of this chapter, item 1.1., and in pro- pylene 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. 10491Ð For use only as a clarifying agent at a level not exceeding 0.35 31Ð3). 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 de- rived from propylene).
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Substances Limitations
Sodium 2,2′-methylenebis(4,6-di-tert-butylphenyl)phosphate For use only: (CAS Reg. No. 85209Ð91Ð2). 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, de- scribed in table 2 of ¤ 176.170(c), or foods of all types, lim- ited 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 com- plying 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, IVÐB, VIÐA, VIÐB, and VIIÐB as iden- tified 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, IVÐA, V, VIÐC, and VIIÐA as identified in Table 1 of ¤ 176.170(c) of this chapter and limited to conditions of use C through G de- scribed 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 ac- cordance 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 Food and Drug Administration free the term ‘‘colorant’’ includes sub- of charge from the Center for Food stances such as optical brighteners and Safety and Applied Nutrition, (HFS– fluorescent whiteners, which may not 200) Food and Drug Administration, 200 themselves be colored, but whose use is C St. SW., Washington, DC 20204. intended to affect the color of a food- (d) Color additives and their lakes contact material. listed for direct use in foods, under the
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provisions of the color additive regula- chapter, may also be used as colorants tions in parts 73, 74, 81, and 82 of this for food-contact polymers. (e) List of substances:
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. 59487Ð23Ð9). ¤ 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. 74441Ð05Ð7). ¤ 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. 81Ð33Ð4). 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. 116Ð75Ð6). 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. 84632Ð65Ð5). 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-α-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-α-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. 129423Ð54Ð7). 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. 154946Ð66Ð4). 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. 68186Ð90Ð3). 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 ex- ceed 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 com- plying 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. 68186Ð91Ð4). 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. 4051Ð63Ð2). 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. 3089Ð17Ð6). 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. 65212Ð77Ð3). 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. 72102Ð mers. The finished articles are to contact food only under 84Ð2). 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. 5521Ð31Ð3). 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. 5280Ð80Ð8). 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. 68259Ð05Ð2). 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. 77804Ð81Ð0). 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. 1533Ð45Ð5). 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, IVÐB, VIÐA, VIÐB, VIIÐB, and VIII at temperatures not to ex- ceed 275 °F.
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Substances Limitations
High-purity furnace black (CAS Reg. No. 1333Ð86Ð4) 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 incor- porated 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 (HFSÐ200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., rm. 3321, Washington, DC, 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 require- ments 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. 10101Ð66Ð3).. 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. 5242Ð49Ð9) 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. 2397Ð00Ð4) and only under conditions of use D, E, F, and G described in 4,4′-bis(2-benzoxazolyl)stilbene (CAS Registry No. 1533Ð45Ð 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. 3333Ð62Ð8) 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. 8007Ð18Ð9). 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. 4118Ð16Ð5). 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, IVÐA, and V, described in table 1, ¤ 176.170(c) of this chapter, the finished articles are to con- tact 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. 147Ð14Ð8). 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 per- cent 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. 106276Ð80Ð6). 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.30125Ð47Ð4). under conditions of use C through H, as described in table 2 of ¤ 176.170(c) of this chapter; provided further that the fin- ished 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. 7128Ð64Ð5). 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, IVÐB, VIÐA, VIÐB, VIÐC, VIIÐB, and VIII under conditions of use A through H de- scribed 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 com- plying 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 per- cent 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 com- plying 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] use in, or to be fabricated as, food con- EDITORIAL NOTE: For FEDERAL REGISTER ci- tainers or food-processing or handling tations affecting § 178.3297, see the List of equipment, subject to the provisions of CFR Sections Affected, which appears in the this section. Finding Aids section of the printed volume (a) The corrosion inhibitors are pre- and on GPO Access. pared from substances identified in this section and used subject to the limita- § 178.3300 Corrosion inhibitors used tions prescribed. for steel or tinplate. (b) The following corrosion inhibitors Corrosion inhibitors may be safely or adjuvants are used in amounts not used for steel or tinplate intended for to exceed those reasonably required to
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accomplish the intended physical or emulsifiers and/or surface-active technical effect: agents in the manufacture of articles (1) Corrosion inhibitors (active ingre- or components of articles intended for dients) used in packaging materials for use in producing, manufacturing, pack- the packaging of steel or tinplate or ar- ing, processing, preparing, treating, ticles fabricated therefrom: packaging, transporting, or holding food, subject to the provisions of this List of substances Limitations section. Dicyclohexylamine and its salts of (a) The quantity used shall not ex- fatty acids derived from animal ceed the amount reasonably required or vegetable oil. Dicyclohexylamine nitrite. to accomplish the intended technical Morpholine and its salts of fatty effect; and the quantity that may be- acids derived from animal or come a component of food as a result of vegetable oils. such use shall not be intended to, nor in fact, accomplish any physical or (2) Adjuvants employed in the appli- technical effect in the food itself. cation and use of corrosion inhibitors: (b) The use as an emulsifier and/or List of substances Limitations surface-active agent in any substance or article that is the subject of a regu- Propylene glycol. lation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with § 178.3400 Emulsifiers and/or surface- any specifications and limitations pre- active agents. scribed by such regulation for the fin- The substances listed in paragraph ished form of the substance or article. (c) of this section may be safely used as (c) List of substances:
List of substances Limitations
α-Alkyl-, α-alkenyl-, and α-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 α-(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 α-(Z)-9-octadecenyl-omega- surface. hydroxypoly(oxyethylene) having an average poly(oxyethylene) content of 18 moles and α-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 C10ÐC18 with not less than 50 per- 1. As provided in ¤ 176.170 of this chapter. cent C14ÐC16). 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 de- scribed 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-modi- fied 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. α-Alkyl-omega-hydroxypoly(oxyethylene) produced by con- densation of 1 mole of C11–C15 straight-chain randomly substitued secondary alcohols with an average of 7Ð20 moles of ethylene oxide.
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List of substances Limitations
alpha Olefin sulfonate [alkyl group is in the range of C10ÐC18 For use only: with not less than 50 percent C14ÐC16], 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 coat- ings 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. 30174Ð67Ð5). 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 160Ð180, saponification number 210Ð of nonfood articles complying with ¤¤ 175.105, 175.300, 235, iodine number 2Ð15, and epoxy groups 0Ð0.4 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. 144093Ð88Ð9]).. α-Di-sec-butylphenyl-omega-hydroxypoly(oxyethylene) pro- duced by the condensation of 1 mole of di-sec-butylphenol with an average of 4Ð14 or 30Ð50 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 com- ponent of the blend shall be in the range 4Ð14 or 30Ð50; sec-butyl groups are predominantly (90 percent or more) o-, p-substituents. Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294Ð49Ð For use only as an emulsifier at levels not to exceed 5 percent 8). by weight of polymers intended for use in coatings. α-Dodecyl-omega-hydroxpoly (oxyethylene) mixture of dihydro- gen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 103Ð111 and that are produced by the esterification of the condensation product of 1 mole of n-dodecyl alcohol with 4Ð4.5 moles of ethylene oxide. α-(p-Dodecylphenyl)-omega-hydroxypoly (oxyethylene) pro- duced by the condensation of 1 mole of dodecylphenol (dodecyl group is a propylene tetramer isomer) with an aver- age of 4Ð14 or 30Ð50 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 4Ð14 or 30Ð50. Naphthalene sulfonic acid-formaldehyde condensate, sodium For use only: salt (CAS Reg. No. 9084Ð06Ð4). 1. At levels not to exceed 10 micrograms/in2 (0.16 mg/dm2) in vinylidene chloride copolymer or homopolymer coatings ap- plied 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 ap- plied to films of polyethylene phthalate polymers complying with ¤ 177.1630 of this chapter.
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List of substances Limitations
α-(p-nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 49Ð59 and that are produced by the esterification of a-(p-nonylphenyl)-omega- hydroxypoly (oxyethylene) complying with the identity pre- scribed in ¤ 178.3400(c) and having an average poly(oxyethylene) content of 5.5Ð6.5 moles. α-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 62Ð72 and that are produced by the esterification of ′-(p-nonylphenyl)omega- hydroxypoly (oxyethylene) complying with the identity pre- scribed in ¤ 178.3400(c) and having an average poly(oxyethylene) content of 9Ð10 moles. α-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 98Ð110 and that are produced by the esterification of α-(p-nonylphenyl)-omega- hydroxypoly (oxyethylene) complying with the identity pre- scribed in ¤ 178.3400(c) and having an average poly(oxyethylene) content of 45Ð55 moles. α-(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 4Ð14 or 30Ð 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 4Ð14 or 30Ð50. α-(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(C10ÐC12) ether sulfosuccinate, diso- For use only at levels not to exceed 5 percent by weight of dium salt (CAS Reg. No. 68954Ð91Ð6). total monomers used in the emulsion polymerization of poly- vinyl acetate, acrylic, and vinyl/acrylic polymers intended for use as coatings for paper and paperboard. Poly[(methylene-p-nonylphenoxy) poly(oxypropylene)(4Ð12 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) (45Ð48 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 11,000Ð Such polyolefin film and polyolefin coatings shall have an av- 18,000; hydroxyl number 6.2Ð10.2; ácloud 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 40Ð50, acid number 0Ð2, hydroxyl number 60Ð108, oxy- ethylene content 70Ð74 pct. Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate) meeting the following specifications: Saponification number 41Ð52, oxyethylene content 66Ð70.5 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) meet- ing the following specifications: Saponification number 80Ð 95, oxyethylene content 46Ð50 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 C8–C16. Sorbitan monolaurate meeting the following specifications. Sa- ponification number 153Ð170; and hydroxyl number 330Ð360.
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List of substances Limitations
Sorbitan monooleate meeting the following specifications: Sa- ponification number 145Ð160, hydroxyl number 193Ð210. Sorbitan monopalmitate meeting the following specifications: Saponification No. 140Ð150; and hydroxyl No. 275Ð305. Sorbitan monostearate conforming to the identity prescribed in ¤ 172.842 of this chapter. Sorbitan trioleate meeting the following specifications: Saponi- fication No. 170Ð190; and hydroxyl No. 55Ð70. Sorbitan tristearate meeting the following specifications: Sa- ponification No. 176Ð188; and hydroxyl No. 66Ð80. 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. 39354Ð45Ð5). total monomers used in the emulsion polymerization of poly- vinyl 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 9Ð10 moles of of polyvinyl acetate and vinyl-acrylate copolymers intended ethylene oxide) (CAS Reg. No. 9040Ð38Ð4). for use as coatings for paper and paperboard. α-[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 4Ð14 or 30Ð40 moles of ethylene oxide; if a blend of prod- ucts 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 4Ð14 or 30Ð50. Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecyl-sulfosuccinate For use only as a polymerization emulsifier for resins applied to tea-bag material. α-Tridecyl-omega-hydroxypoly (oxyethylene) mixture of di- hydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 75Ð85 and that are produced by the esterification of the condensation product of one mole of ‘‘oxo’’ process tridecyl alcohol with 5.5Ð6.5 moles of ethylene oxide. α-Tridecyl-omega-hydroxypoly (oxyethyl-ene) mixture of di- hydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 58Ð70 and that are produced by the esterification of the condensation product of one mole of ‘‘oxo’’ process tridecyl alcohol with 9Ð10 moles of ethylene oxide.
(d) The provisions of this section are (b) They are added to the formulated not applicable to emulsifiers and/or polymer prior to extrusion. surface-active agents listed in (c) The quantity used shall not ex- § 175.105(c)(5) of this chapter and used in ceed that required to accomplish the food-packaging adhesives complying intended technical effect. with § 175.105 of this chapter. § 178.3480 Fatty alcohols, synthetic. EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 178.3400, see the List of Synthetic fatty alcohols may be safe- CFR Sections Affected, which appears in the ly used as components of articles in- Finding Aids section of the printed volume tended for use in contact with food, and on GPO Access. 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 in contact with food in accordance The ester stearyl palmitate or with the following prescribed condi- palmityl stearate or mixtures thereof tions: may be safely used as adjuvants in (a) The food additive consists of fatty food-packaging materials when used in 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. styrene intended for use in contact (b) It is used or intended for use as with food. follows:
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(1) As substitutes for the cor- § 178.3500 Glycerin, synthetic. responding naturally derived fatty al- Synthetic glycerin may be safely cohols permitted for use as components used as a component of articles in- of articles intended for use in contact tended for use in packaging materials with food by existing regulations in for food, subject to the provisions of parts 174, 175, 176, 177, 178 and § 179.45 of this section: this chapter: Provided, That the use is (a) It is produced by the hydro- in compliance with any prescribed lim- genolysis of carbohydrates, and shall itations. contain not in excess of 0.2 percent by (2) As substitutes for the cor- weight of a mixture of butanetriols. responding naturally derived fatty al- (b) It is used in a quantity not to ex- cohols used as intermediates in the ceed that amount reasonably required synthesis of food additives and other to produce its intended physical or substances permitted for use as compo- technical effect, and in accordance nents of food-contact articles. (c) Synthetic fatty alcohols identi- with any limitations prescribed by ap- fied in paragraph (c)(1) of this section plicable regulations in parts 174, 175, may contain not more than 0.8 weight 176, 177, 178 and 179 of this chapter. It percent of total diols as determined by shall not be intended to, nor in fact ac- a method titled ‘‘Diols in Monohydroxy complish, any direct physical or tech- Alcohol by Miniature Thin Layer Chro- nical effect in the food itself. matography (MTLC),’’ which is incor- § 178.3505 Glyceryl tri-(12-acetoxy- porated by reference. Copies are avail- stearate). able from the Center for Food Safety and Applied Nutrition (HFS–200), Food Glyceryl tri-(12-acetoxystearate) and Drug Administration, 200 C St. (CAS Reg. No. 139–43–5) may be safely SW., Washington, DC 20204, or available used as a component of articles in- for inspection at the Office of the Fed- tended for use in producing, manufac- eral Register, 800 North Capitol Street, turing, packing, processing, preparing, NW., suite 700, Washington, DC 20408. treating, packaging, transporting, or (1) Synthetic fatty alcohols. (i) Hexyl, holding food, subject to the provisions octyl, decyl, lauryl, myristyl, cetyl, of this section. and stearyl alcohols meeting the speci- (a) The additive is applied to the sur- fications and definition prescribed in face of calcium carbonate at a level not § 172.864 of this chapter, except that to exceed 1 weight-percent of the total they may contain not more than 0.8 mixture. weight percent total diols. (b) The calcium carbonate/glyceryl (ii) Lauryl, myristyl, cetyl, and ste- tri-(12-acetoxystearate) mixture is used aryl alcohols manufactured by the as an adjuvant in polymers in contact process described in § 172.864(a)(2) of with nonfatty foods at a level not to this chapter such that lauryl and exceed 20 weight-percent of the poly- myristyl alcohols meet the specifica- mer. tions in § 172.864(a)(1)(i) of this chapter, [50 FR 1503, Jan. 11, 1985] and cetyl and stearyl alcohols meet the specifications in § 172.864(a)(1)(ii) of this § 178.3520 Industrial starch-modified. chapter. Industrial starch-modified may be (2) Conditions of use. (i) Synthetic safely used as a component of articles fatty alcohols as substitutes for the intended for use in producing, manu- corresponding naturally derived fatty facturing, packing, processing, pre- alcohols permitted for use in compli- paring, treating, packaging, trans- ance with § 178.3910. porting, or holding food, subject to the (ii) Synthetic lauryl alcohol as a sub- provisions of this section. stitute for the naturally derived lauryl (a) Industrial starch-modified is iden- alcohol permitted as an intermediate tified as follows: in the synthesis of sodium lauryl sul- (1) A food starch-modified or starch fate used in compliance with § 178.3400. or any combination thereof that has [42 FR 14609, Mar. 15, 1977, as amended at 47 been modified by treatment with one of FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, the reactants hereinafter specified, in 1989] an amount reasonably required to
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achieve the desired functional effect quent treatment as authorized in but in no event in excess of any limita- § 172.892 of this chapter. tion prescribed, with or without subse-
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. β-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 fin- ished 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 sul- fate). 2. Not more than 0.20 pct residual acrylamide. 3. A minimum nitrogen content of 9.0 pct.
(b) The following adjuvants may be use, the label of the food additive con- used as surface-active agents in the tainer shall contain a statement of processing of industrial starch-modi- such limited use. fied: [42 FR 14609, Mar. 15, 1977, as amended at 42 Polyethylene glycol (400) dilaurate. FR 49453, Sept. 27, 1977] Polyethylene glycol (400) monolaurate. Polyoxyethylene (4) lauryl ether. § 178.3530 Isoparaffinic petroleum hy- drocarbons, synthetic. (c) To insure safe use of the indus- trial starch-modified, the label of the Isoparaffinic petroleum hydro- food additive container shall bear the carbons, synthetic, may be safely used name of the additive ‘‘industrial in the production of nonfood articles starch-modified,’’ and in the instance of an industrial starch-modified which is limited with respect to conditions of
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intended for use in producing, manu- American Society for Testing Materials, 1916 facturing, packing, processing, pre- Race St., Philadelphia, PA 19103, or may be paring, treating, packaging, trans- examined at the Office of the Federal Reg- porting, or holding food, subject to the ister, 800 North Capitol Street, NW., suite provisions of this section. 700, Washington, DC 20408. (a) The isoparaffinic petroleum hy- (b) Isoparaffinic petroleum hydro- drocarbons, produced by synthesis from carbons may contain antioxidants au- petroleum gases consist of a mixture of thorized for use in food in an amount liquid hydrocarbons meeting the fol- not to exceed that reasonably required lowing specifications: to accomplish the intended technical Boiling point 63° –260 °C, as determined by effect. ASTM method D86–82, ‘‘Standard Method (c) Isoparaffinic petroleum hydro- for Distillation of Petroleum Products,’’ carbons are used in the production of which is incorporated by reference. Copies nonfood articles. The quantity used may be obtained from the American Soci- shall not exceed the amount reason- ety for Testing Materials, 1916 Race St., ably required to accomplish the in- Philadelphia, PA 19103, or may be exam- ined at the Office of the Federal Register, tended technical effect, and the resid- 800 North Capitol Street, NW., suite 700, ual remaining in the finished article Washington, DC 20408. shall be the minimum amount reason- Ultraviolet absorbance: ably attainable. 260–319 millimicrons—1.5 maximum. 320–329 millimicrons—0.08 maximum. [42 FR 14609, Mar. 15, 1977, as amended at 47 330–350 millimicrons—0.05 maximum. FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, Nonvolatile residue 0.002 gram per 100 milli- 1984] liters maximum. Synthetic isoparaffinic petroleum hydro- § 178.3570 Lubricants with incidental carbons containing antioxidants shall meet food contact. the specified ultraviolet absorbance limits Lubricants with incidental food con- after correction for any absorbance due to tact may be safely used on machinery the antioxidants. The ultraviolet absorbance shall be determined by the procedure de- used for producing, manufacturing, scribed for application to mineral oil under packing, processing, preparing, treat- ‘‘Specifications’’ on page 66 of the ‘‘Journal ing, packaging, transporting, or hold- of the Association of Official Agricultural ing food, subject to the provisions of Chemists,’’ Vol. 45 (February 1962), which is this section: incorporated by reference, disregarding the (a) The lubricants are prepared from last sentence of that procedure. For hydro- carbons boiling below 121 °C, the nonvolatile one or more of the following sub- residue shall be determined by ASTM meth- stances: od D1353–78, ‘‘Standard Test Method for Non- (1) Substances generally recognized volatile Matter in Volatile Solvents for Use as safe for use in food. in Paint, Varnish, Lacquer, and Related (2) Substances used in accordance ° Products;’’ for those boiling above 121 C, with the provisions of a prior sanction ASTM procedure D381–80, ‘‘Standard Test Method for Existent Gum in Fuels by Jet or approval. Evaporation,’’ which are incorporated by ref- (3) Substances identified in this para- erence. Copies may be obtained from the 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. 94270Ð86Ð7). percent by weight of the lubricant. BHA. BHT. α-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. 9038Ð95Ð3. α-Butyl-omega-hydroxypoly(oxypropylene); minimum molecular Do. weight 1,500; Chemical Abstracts Service Registry No. 9003Ð13Ð8. Castor oil ...... Do. Castor oil, dehydrated ...... Do.
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Substances Limitations
Castor oil, partially dehydrated ...... Do. Dialkyldimethylammonium aluminum silicate (CAS Reg. No. For use only as a gelling agent in mineral oil lubricants at a 68953Ð58Ð2), 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. 629Ð11Ð8), where the alkyl groups are derived from hydrogenated tallow fatty acids (C14ÐC18) 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. 1809Ð14Ð9) ...... 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. 17265Ð14Ð4) ...... 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. 139Ð33Ð3) ...... 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 sub- sequent ethoxylation with 4 to 12 moles of ethylene oxide;. 2. Poly(methylene-p-nonylphenoxy) poly(oxyethylene) mix- ture of dihydrogen phosphate and monohydrogen phos- phate 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. 56831Ð62Ð0). 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. 95Ð38Ð5). 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. 35074Ð77Ð2). by weight of the lubricant. α-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. 9003Ð11Ð6. 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. 110Ð For use as a corrosion inhibitor at levels not to exceed 0.5 per- 25Ð8). 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. 68411Ð46Ð1). cent by weight of the lubricant. Petrolatum ...... Complying with ¤ 178.3700. Addition to food not to exceed 10 parts per million. Phenyl-α-and/or phenyl-β-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 (C12ÐC14) primary amines (CAS Reg. No. 68187Ð inlubricants at a level not to exceed 0.5 percent by weight of 67Ð7). the lubricant. 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. 192268Ð65Ð8). level not to exceed 0.5 percent by weight of the lubricant.
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Substances Limitations
Polyurea, having a nitrogen content of 9Ð14 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 35,000Ð140,000 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. 6683Ð19Ð8). 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. 126019Ð82Ð7). els not to exceed 0.5 percent by weight of the lubricant. Triphenyl phosphorothionate (CAS Reg. No. 597Ð82Ð0) ...... 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. 31570Ð For use only as a stabilizer at levels not to exceed 0.5 percent 04Ð4). 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. 41484Ð35Ð9). by weight of the lubricant. Zinc sulfide ...... For use at levels not to exceed 10 percent by weight of the lu- bricant.
(b) The lubricants are used on food- modified complying with § 178.3520, in- processing equipment as a protective tended for use as a component of arti- antirust film, as a release agent on gas- cles that contact food. kets or seals of tank closures, and as a lubricant for machine parts and equip- § 178.3610 a-Methylstyrene- ment in locations in which there is ex- vinyltoluene resins, hydrogenated. posure of the lubricated part to food. Hydrogenated α-methylstyrene- The amount used is the minimum re- vinyltoluene copolymer resins having a quired to accomplish the desired tech- molar ratio of 1 α-methylstyrene to 3 nical effect on the equipment, and the vinyltoluene may be safely used as addition to food of any constituent components of polyolefin film intended identified in this section does not ex- for use in contact with food, subject to ceed the limitations prescribed. the following provisions: (c) Any substance employed in the (a) Hydrogenated α-methylstyrene- production of the lubricants described vinyltoluene copolymer resins have a in this section that is the subject of a drop-softening point of 125° to 165 °C regulation in parts 174, 175, 176, 177, 178 and a maximum absorptivity of 0.17 and § 179.45 of this chapter conforms liter per gram centimeter at 266 with any specification in such regula- nanometers, as determined by methods tion. titled ‘‘Determination of Softening Point (Drop Method)’’ and ‘‘Determina- [42 FR 14609, Mar. 15, 1977] tion of Unsaturation of Resin 1977,’’ EDITORIAL NOTE: For FEDERAL REGISTER ci- which are incorporated by reference. tations affecting § 178.3570, see the List of Copies are available from the Center CFR Sections Affected, which appears in the for Food Safety and Applied Nutrition Finding Aids section of the printed volume (HFS–200), Food and Drug Administra- and on GPO Access. tion, 200 C St. SW., Washington, DC 20204, or available for inspection at the § 178.3600 Methyl glucoside-coconut oil Office of the Federal Register, 800 ester. North Capitol Street, NW., suite 700, Methyl glucoside-coconut oil ester Washington, DC 20408. identified in § 172.816(a) of this chapter (b) The polyolefin film is produced may be safely used as a processing aid from olefin polymers complying with (filter aid) in the manufacture of § 177.1520 of this chapter, and the aver- starch, including industrial starch- age thickness of the film in the form in
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which it contacts food does not exceed Technical white mineral oil containing 0.002 inch. antioxidants shall meet the specified ultraviolet absorbance limits after cor- [42 FR 14609, Mar. 15, 1977, as amended at 47 rection for any absorbance due to the FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, 1989] antioxidants. The ultraviolet absorb- ance shall be determined by the proce- § 178.3620 Mineral oil. dure described for application to min- eral oil under ‘‘Specification’’ on page Mineral oil may be safely used as a 66 of the ‘‘Journal of the Association of component of nonfood articles intended Official Agricultural Chemists,’’ Vol- for use in contact with food, subject to ume 45 (February 1962) (which is incor- the provisions of this section: porated by reference; copies are avail- (a) White mineral oil meeting the able from the Center for Food Safety specifications prescribed in § 172.878 of and Applied Nutrition (HFS–200), Food this chapter may be used as a compo- and Drug Administration, 200 C St. nent of nonfood articles provided such SW., Washington, DC 20204, or available use complies with any applicable limi- for inspection at the Office of the Fed- tations in parts 170 through 189 of this eral Register, 800 North Capitol Street, chapter. The use of white mineral oil in NW., suite 700, Washington, DC 20408), or on food itself, including the use of disregarding the last two sentences of white mineral oil as a protective coat- that procedure and substituting there- ing or release agent for food, is subject for the following: Determine the ab- to the provisions of § 172.878 of this sorbance of the mineral oil extract in a chapter. 10-millimeter cell in the range from (b) Technical white mineral oil iden- 260–350 mµ, inclusive, compared to the tified in paragraph (b)(1) of this section solvent control. If the absorbance so may be used as provided in paragraph measured exceeds 2.0 at any point in (b)(2) of this section. range 280–350 mµ, inclusive, dilute the (1) Technical white mineral oil con- extract and the solvent control, respec- sists of specially refined distillates of tively, to twice their volume with di- virgin petroleum or of specially refined methyl sulfoxide and remeasure the ab- distillates that are produced syn- sorbance. Multiply the remeasured ab- thetically from petroleum gases. Tech- sorbance values by 2 to determine the nical white mineral oil meets the fol- absorbance of the mineral oil extract lowing specifications: per centimeter optical pathlength. (i) Saybolt color 20 minimum as de- (2) Technical white mineral oil may termined by ASTM method D156–82, be used wherever mineral oil is per- ‘‘Standard Test Method for Saybolt mitted for use as a component of Color of Petroleum Products (Saybolt nonfood articles complying with Chromometer Method),’’ which is in- §§ 175.105, 176.200, 176.210, 177.2260, corporated by reference. Copies may be 177.2600, and 177.2800 of this chapter and obtained from the American Society §§ 178.3570 and 178.3910. for Testing Materials, 1916 Race St., (3) Technical white mineral oil may Philadelphia, PA 19103, or may be ex- contain any antioxidant permitted in amined at the Office of the Federal food by regulations issued in accord- Register, 800 North Capitol Street, ance with section 409 of the Act, in an NW., suite 700, Washington, DC 20408. amount not greater than that required (ii) Ultraviolet absorbance limits as to produce its intended effect. follows: (c) Mineral oil identified in para- graph (c)(1) of this section may be used Maximum as provided in paragraph (c)(2) of this absorb- section. µ ance per Wavelength (m ) centimeter (1) The mineral oil consists of virgin optical pathlength petroleum distillates refined to meet the following specifications: 280 to 289 ...... 4.0 (i) Initial boiling point of 450 °F min- 290 to 299 ...... 3.3 imum. 300 to 329 ...... 2.3 (ii) Color 5.5 maximum as determined 330 to 350 ...... 0.8 by ASTM method D1500–82, ‘‘Standard
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Test Method for ASTM Color of Petro- top for connecting to the nitrogen supply. leum Products (ASTM Color Scale),’’ The male fitting should be equipped with which is incorporated by reference. The 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 ±0.1 millimeter, equipped with a coarse, frit- of this section. ted-glass disc, a tetrafluoroethylene polymer (iii) Ultraviolet absorbance limits as stopcock, and a female 24/40 standard tapered follows as determined by the analytical fitting at the opposite end. (Overall length of method described in paragraph (c)(3) of the column with the female joint is 235 milli- this section: meters.) The female fitting should be equipped with glass hooks. Maximum Disc. Tetrafluoroethylene polymer 2-inch absorb- diameter disk approximately 3⁄16-inch thick µ ance per Wavelength (m ) centimeter with a hole bored in the center to closely fit optical the stem of the chromatographic tube. pathlength 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 177.2800 of this chapter. spectrophotometer performance only, optical (3) The analytical method for deter- path length in the range 1,000 centimeter ± mining ultraviolet absorbance limit is 0.005 centimeter. With distilled water in the cells, determine any absorbance differences. as follows: Spectrophotometer. Spectral range 250 milli- GENERAL INSTRUCTIONS microns—400 millimicrons with spectral slit 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. glassware, including stoppers and stopcocks, Absorbance accuracy 1 ±0.05 at 0.4 absorb- under ultraviolet light to detect any residual ance. fluorescent contamination. As a pre- Wavelength accuracy, ±1.0 millimicron. cautionary measure it is recommended prac- tice to rinse all glassware with purified iso- Nitrogen cylinder. Water-pumped or equiva- octane immediately before use. No grease is lent purity nitrogen in cylinder equipped to be used on stopcocks or joints. Great care with regulator and valve to control flow at 5 to avoid contamination of oil samples in p.s.i.g. handling and to assure absence of any extra- neous material arising from inadequate 1 As determined by procedure using potas- packaging is essential. Because some of the sium chromate for reference standard and polynuclear hydrocarbons sought in this test described in National Bureau of Standards are very susceptible to photo-oxidation, the Circular 484, Spectrophotometry, U.S. De- entire procedure is to be carried out under partment of Commerce (1949). The accuracy subdued light. is to be determined by comparison with the standard values at 290, 345, and 400 milli- APPARATUS microns. Circular 484 is incorporated by ref- Separatory funnels. 250-milliliter, 500-milli- erence. Copies are available from the Center liter, 1,000-milliliter, and preferably 2,000- for Food Safety and Applied Nutrition (HFS– milliliter capacity, equipped with tetra- 200), Food and Drug Administration, 200 C St. fluoroethylene polymer stopcocks. SW., Washington, DC 20204, or available for Reservoir. 500-milliliter capacity, equipped inspection at the Office of the Federal Reg- with a 24/40 standard taper male fitting at ister, 800 North Capitol Street, NW., suite the bottom and a suitable ball-joint at the 700, Washington, DC 20408.
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REAGENTS AND MATERIALS n-Hexadecane, 99-percent olefin-free. Dilute 1.0 milliliter of n-hexadecane to 25 milliliters Organic solvents. All solvents used through- with isooctane and determine the absorbance out the procedure shall meet the specifica- in a 5-centimeter cell compared to isooctane tions and tests described in this specifica- as reference point between 280 mµ–400 mµ. tion. The isooctane, benzene, acetone, and The absorbance per centimeter path length methyl alcohol designated in the list fol- shall not exceed 0.00 in this range. Purify, if lowing this paragraph shall pass the fol- necessary, by percolation through activated lowing test: silica gel or by distillation. To the specified quantity of solvent in a Methyl alcohol, A.C.S. reagent grade. Use 250-milliliter Erlenmeyer flask, add 1 milli- 10.0 milliliters of methyl alcohol. Purify, if liter of purified n-hexadecane and evaporate necessary, by distillation. on the steam bath under a stream of nitro- Dimethyl sulfoxide. Spectrophotometric gen (a loose aluminum foil jacket around the grade (Crown Zellerbach Corporation, flask will speed evaporation). Discontinue Camas, Washington, or equivalent). Absorb- evaporation when not over 1 milliliter of res- ance (1-centimeter cell, distilled water ref- idue remains. (To the residue from benzene erence, sample completely saturated with ni- add a 10-milliliter portion of purified iso- trogen). octane, reevaporate, and repeat once to in- sure complete removal of benzene.) Absorb- Alternatively, the evaporation time can be Wavelength ance (max- reduced by using the optional evaporation imum) flask. In this case the solvent and n-hexa- 261.5 ...... 1.00 decane are placed in the flask on the steam 270 ...... 20 bath, the tube assembly is inserted, and a 275 ...... 09 stream of nitrogen is fed through the inlet 280 ...... 06 tube while the outlet tube is connected to a 300 ...... 015 solvent trap and vacuum line in such a way as to prevent any flow-back of condensate There shall be no irregularities in the ab- into the flask. sorbance curve within these wavelengths. Dissolve the 1 milliliter of hexadecane res- Phosphoric acid. 85 percent A.C.S. reagent idue in isooctane and make to 25 milliliters grade. volume. Determine the absorbance in the 5- Sodium borohydride. 98 percent. centimeter path length cells compared to Magnesium oxide (Sea Sorb 43, Food Machin- isooctane as reference. The absorbance of the ery Company, Westvaco Division, distributed by solution of the solvent residue (except for chemical supply firms, or equivalent). Place 100 methyl alcohol) shall not exceed 0.01 per cen- grams of the magnesium oxide in a large µ timeter path length between 280 and 400 m . beaker, add 700 milliliters of distilled water For methyl alcohol this absorbance value to make a thin slurry, and heat on a steam shall be 0.00. bath for 30 minutes with intermittent stir- Isooctane (2,2,4-trimethylpentane). Use 180 ring. Stir well initially to insure that all the milliliters for the test described in the pre- adsorbent is completely wetted. Using a ceding paragraph. Purify, if necessary, by Buchner funnel and a filter paper (Schleicher passage through a column of activated silica & Schuell No. 597, or equivalent) of suitable gel (Grade 12, Davison Chemical Company, diameter, filter with suction. Continue suc- Baltimore, Maryland, or equivalent) about 90 tion until water no longer drips from the centimeters in length and 5 centimeters to 8 funnel. Transfer the adsorbent to a glass centimeters in diameter. trough lined with aluminum foil (free from Benzene, A.C.S. reagent grade. Use 150 milli- rolling oil). Break up the magnesia with a liters for the test. Purify, if necessary, by clean spatula and spread out the adsorbent distillation or otherwise. on the aluminum foil in a layer about 1 cen- Acetone, A.C.S. reagent grade. Use 200 milli- timeter to 2 centimeters thick. Dry for 24 liters for the test. Purify, if necessary, by hours at 160 °C ±1 °C. Pulverize the magnesia distillation. with mortar and pestle. Sieve the pulverized Eluting mixtures: adsorbent between 60–180 mesh. Use the mag- 1. 10 percent benzene in isooctane. Pipet 50 nesia retained on the 180-mesh sieve. milliliters of benzene into a 250-milliliter Celite 545. Johns Mansville Company, diato- glass-stoppered volumetric flask and adjust maceous earth, or equivalent. to volume with isooctane, with mixing. Magnesium oxide-Celite 545 mixture (2+1) by 2. 20 percent benzene in isooctane. Pipet 50 weight. Place the magnesium oxide (60–180 milliliters of benzene into a 250-milliliter mesh) and the Celite 545 in 2 to 1 propor- glass-stoppered volumetric flask and adjust tions, respectively, by weight in a glass- to volume with isooctane, with mixing. stoppered flask large enough for adequate 3. Acetone-benzene-water mixture. Add 20 mixing. Shake vigorously for 10 minutes. milliliters of water to 380 milliliters of ace- Transfer the mixture to a glass trough lined tone and 200 milliliters of benzene, and mix. with aluminum foil (free from rolling oil)
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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-milli- meter 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 op- in 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 tions of preequilibrated isooctane to give a the corrected absorbance per centimeter total volume of the oil and solvent of 75 mil- pathlength exceeds the limits prescribed in liliters. Shake the funnel vigorously for 2 this paragraph, proceed as follows: Quan- minutes. Set up three 250-milliliter sepa- titatively transfer the isooctane solution to ratory funnels with each containing 30 milli- a 125-milliliter flask equipped with 24/40 liters of pre-equilibrated isooctane. After joint, and evaporate the isooctane on the separation of liquid phases, carefully draw steam bath under a stream of nitrogen to a off lower layer into the first 250-milliliter volume of 1 milliliter of hexadecane. Add 10 separatory funnel and wash in tandem with milliliters of methyl alcohol and approxi- the 30-milliliter portions of isooctane con- mately 0.3 gram of sodium borohydride. tained in the 250-milliliter separatory fun- (Minimize exposure of the borohydride to the nels. Shaking time for each wash is 1 atmosphere. A measuring dipper may be
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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 in isooctane to the reservoir and continue for 30 minutes at room temperature, with the percolation at 2–3 milliliters per minute intermittent swirling. At the end of this pe- until all this solvent mixture has been re- riod, disconnect the flask and evaporate the moved from the column. Discard all the methyl alcohol on the steam bath under ni- elution solvents collected up to this point. trogen until the sodium borohydride begins Add 300 milliliters of the acetone-benzene- to come out of the solution. Then add 10 mil- water mixture to the reservoir and percolate liliters of isooctane and evaporate to a vol- through the column to eluate the ume of about 2–3 milliliters. Again, add 10 polynuclear compounds. Collect the eluate in milliliters of isooctane and concentrate to a a clean 1-liter separatory funnel. Allow the volume of approximately 5 milliliters. Swirl column to drain until most of the solvent the flask repeatedly to assure adequate mixture is removed. Wash the eluate three washing of the sodium borohydride residues. times with 300-milliliter portions of distilled Fit the tetrafluoroethylene polymer disc water, shaking well for each wash. (The addi- on the upper part of the stem of the tion of small amounts of sodium chloride fa- chromatographic tube, then place the tube cilitates separation.) Discard the aqueous with the disc on the suction flask and apply layer after each wash. After the final separa- the vacuum (approximately 135 millimeters tion, filter the residual benzene through an- Hg pressure). Weigh out 14 grams of the 2:1 hydrous sodium sulfate pre-washed with ben- magnesium oxide-Celite 545 mixture and zene (see Sodium sulfate under ‘‘Reagents pour the adsorbent mixture into the and Materials’’ for preparation of filter) into chromatographic tube in approximately 3- a 250-milliliter Erlenmeyer flask (or option- centimeter layers. After the addition of each ally into the evaporation flask). Wash the layer, level off the top of the adsorbent with separatory funnel with two additional 20- a flat glass rod or metal plunger by pressing milliliter portions of benzene which are also down firmly until the adsorbent is well filtered through the sodium sulfate. Add 1 packed. Loosen the topmost few millimeters milliliter of n-hexadecane and completely re- of each adsorbent layer with the end of a move the benzene by evaporation under ni- metal rod before the addition of the next trogen, using the special procedure to elimi- layer. Continue packing in this manner until nate benzene as previously described under all the 14 grams of the adsorbent is added to ‘‘Organic solvents.’’ Quantitatively transfer the tube. Level off the top of the adsorbent the residue with isooctane to a 200-milliliter by pressing down firmly with a flat glass rod volumetric flask and adjust to volume. De- or metal plunger to make the depth of the termine the absorbance of the solution in the adsorbent bed approximately 12.5 centi- 1-centimeter pathlength cells compared to meters in depth. Turn off the vacuum and re- isooctane as reference between 250 mµ–400 move the suction flask. Fit the 500–milliliter mµ. Correct for any absorbance derived from reservoir onto the top of the the reagents as determined by carrying out chromatographic column and prewet the col- the procedure without an oil sample. If ei- umn by passing 100 milliliters of isooctane ther spectrum shows the characteristic ben- through the column. Adjust the nitrogen zene peaks in the 250 mµ–260 mµ region, evap- pressure so that the rate of descent of the orate the solution to remove benzene by the isooctane coming off the column is between procedure under ‘‘Organic solvents.’’ Dis- 2–3 milliliters per minute. Discontinue pres- solve the residue, transfer quantitatively, sure just before the last of the isooctane and adjust to volume in isooctane in a 200- reaches the level of the adsorbent. (Caution: milliliter volumetric flask. Record the ab- Do not allow the liquid level to recede below sorbance again. If the corrected absorbance the adsorbent level at any time.) Remove the does not exceed the limits proposed in this reservoir and decant the 5–milliliter iso- paragraph, the oil meets the proposed ultra- octane concentrate solution onto the column violet absorbance specifications. and with slight pressure again allow the liq- uid level to recede to barely above the ad- (d) Mineral oil identified in para- sorbent level. Rapidly complete the transfer graph (d)(1) of this section may be used similarly with two 5–milliliter portions of as provided in paragraph (d)(2) of this isooctane, swirling the flask repeatedly each section. time to assure adequate washing of the res- (1) The mineral oil consists of virgin idue. Just before the final 5–milliliter wash petroleum distillates refined to meet reaches the top of the adsorbent, add 100 mil- the following specifications: liliters of isooctane to the reservoir and con- (i) Distillation endpoint at 760 milli- tinue the percolation at the 2–3 milliliters ° per minute rate. Just before the last of the meters pressure not to exceed 371 C, isooctane reaches the adsorbent level, add with a maximum residue not to exceed 100 milliliters of 10 percent benzene in iso- 2 percent, as determined by ASTM octane to the reservoir and continue the per- method D86–82, ‘‘Standard Method for
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Distillation of Petroleum Products,’’ dating 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 suitable ball joint at the top for connecting of this section. to the nitrogen supply. The female fitting of (ii) Ultraviolet absorbance limits as the chromatographic columns described in follows as determined by the method items I. C and D above and the male fitting described in paragraph (d)(3) of this of the reservoir described in this item E section. should both be equipped with glass hooks. (NOTE: Rubber stoppers are not to be used. Maximum absorb- Stopcock grease is not to be used on ground- µ ance per glass joints in this method.) Wavelength (m ) centimeter optical F. A spectrophotometer equipped to auto- pathlength matically record absorbance of liquid sam- ples in 1-centimeter pathlength cells in the 280 to 299 ...... 2.3 µ 300 to 319 ...... 1.2 spectral region of 280–400 m with a spectral 320 to 359 ...... 8 slit width of 2 mµ or less. At an absorbance 360 to 400 ...... 3 level of about 0.4, absorbance measurements shall be repeatable within ±0.01 and accurate (iii) Pyrene content not to exceed a within ±0.05. Wavelength measurements shall maximum of 25 parts per million as de- be repeatable with ±0.2 mµ and accurate termined by the method described in within ±1.0 mµ. Instrument operating condi- paragraph (d)(3) of this section. tions are selected to realize this performance under dynamic (automatic) recording oper- (2) The mineral oil may be used only ations. Accuracy of absorbance measure- in the processing of jute fiber employed ments are determined at 290, 345, and 400 mµ, in the production of textile bags in- using potassium chromate as the reference tended for use in contact with the fol- standard. (National Bureau of Standards Cir- lowing types of food: Dry grains and cular 484, Spectrophotometry, U.S. Depart- dry seeds (for example, beans, peas, ment of Commerce, 1949.) rice, and lentils); whole root crop vege- G. Two fused quartz cells having ± tables of the types identified in 40 CFR pathlengths of 1.00 0.005 centimeter or bet- ter. 180.34(f); unshelled and shelled nuts (in- II. Purity of reagents and materials. Reagent- cluding peanuts); and dry animal feed. grade chemicals shall be used in all tests. It The finished processed jute fiber shall is further specified that each chemical shall contain no more than 6 percent by be tested for purity in accordance with the weight of residual mineral oil. instruction given under ‘‘Reagents and Mate- (3) The analytical method for deter- rials’’ in III below. In addition, a blank run mining ultraviolet absorbance limits by the procedure shall be made on each puri- and pyrene content is as follows: fied lot of reagents and materials. Unless otherwise indicated, references to water I. Apparatus. A. Assorted beakers, sepa- shall be understood to mean distilled water. ratory funnels fitted with tetrafluoro- III. Reagents and materials— A. Organic sol- ethylene polymer stopcocks, and graduated vents. All solvents used throughout the pro- cylinders. cedure shall meet the specifications and B. Volumetric flasks, 200-milliliter. tests described in this section III. The iso- C. A chromatographic column made from octane, benzene, cyclohexane, nitromethane, nominal 1.3 centimeters outside diameter × and n-hexadecane designated shall pass the 75 centimeters glass tubing tapered at one following test: To the specified quantity of end and joined to a 2-millimeter-bore tetra- solvent in a 150-milliliter beaker, add 1 milli- fluoroethylene polymer stopcock. The oppo- liter of purified n-hexadecane and evaporate site end is flanged and joined to a female 24/ on the steam bath under a stream of nitro- 40 standard taper fitting. This provides for gen. Discontinue evaporation when not over accommodating the 500-milliliter reservoir 1 milliliter of residue remains (to the residue described in item I.E below. from benzene and nitromethane add a 10-mil- D. A chromatographic column made from liliter portion of purified isooctane, re-evap- nominal 1.7 centimeters outside diameter × orate, and repeat once to insure complete re- 115 centimeters glass tubing tapered at one moval of solvent). Dissolve the 1 milliliter of end and joined to a 2-millimeter-bore tetra- n-hexadecane residue in isooctane and make fluoroethylene polymer stopcock. The oppo- to 10-milliliter volume. Determine the ab- site end is flanged and joined to a 2.5 centi- sorbance in 1.0-centimeter pathlength cells meters outside diameter × 9.0 centimeters compared to water as reference. The absorb- glass tube having a female 24/40 standard ance of the solution of solvent residue shall taper fitting. This provides for accommo- not exceed 0.05 between 280 and 400 mµ.
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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 store in a vacuum desiccator. Reheating the eluting solution of benzene and isooctane about once a week is necessary if the silica (90 percent benzene and 10 percent isooctane gel is repeatedly removed from the desic- by volume) to the column and continue col- cator. lecting until a total of 250 milliliters of solu- 5. Aluminum oxide (Aluminum Co. of America, tion has been obtained. This may be dis- Grade F-20, or equivalent grade). 80–200 mesh, carded. Now begin to collect the final eluate. purified and activated by the following pro- g. Place a 100-milliliter graduated cylinder cedure: Place about 1 kilogram of aluminum under the column and continue the percola- oxide in a large column and wash with con- tion until a 100-milliliter eluate has been ob- taminant-free benzene until a 200-milliliter tained. sample of the benzene coming off the column h. Measure the amount of chrysene in this will pass the ultraviolet absorption test for 100-milliliter fraction by ultraviolet anal- benzene. This test is performed as stipulated ysis. If the aluminum oxide is satisfactory, under ‘‘Organic solvents’’ in A under III more than 80 percent of the original amount above. (Caution! Remove Benzene From Ad- of chrysene should be found in this fraction.
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(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: voids. All percolations using aluminum oxide Complete removal of the benzene is essen- are performed under nitrogen pressure. The tial. This can be assured by two successive 500-milliliter reservoir described under ‘‘Ap- additions of 5 milliliters of isooctane and re- paratus’’ in E under I above is to be used to evaporation.) hold the elution solvents.) 13. Remove the beaker from the steam bath 5. Prewet the column by adding 40 milli- and cool. liters of isooctane to the column. Adjust ni- 14. Place a sample of 113.5 grams activated trogen pressure so that rate of descent of the 100- 200-mesh silica gel in a 500-milliliter isooctane coming off the column is 2.0 to 3.0 glass-stoppered Erlenmeyer flask. Add to the milliliters per minute. Be careful to main- silica gel 46.2 grams (41 milliliters) of tain the level of solvent in the reservoir to nitromethane. Stopper and shake the flask prevent air from entering the aluminum vigorously until no lumps of silica gel are oxide bed. New or additional solvent is added observed and then shake occasionally during just before the last portion of the previous a period of 1 hour. The resultant solvent enters the bed. To minimize possible nitromethane-treated silica gel is 29 weight-
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percent nitro-methane and 71 weight-percent tervals recorded shall not exceed those pre- silica gel. scribed in paragraph (d)(1)(ii) of this section. 15. Place a small plug of glass wool in the 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- umn, tapping lightly. The resultant silica gel peak (334 m) by the base-line technique de- bed should be about 95 centimeters in depth. scribed in ASTM method E169–63 (Re- Place into a flask 170 milliliters of isooctane approved 1981), ‘‘Standard Recommended saturated with nitromethane. Practices for General Techniques of Ultra- 16. Place a 100-milliliter graduated cyl- violet Quantitative Analysis,’’ which is in- inder under the column and transfer the res- corporated by reference. The availability of idue from the beaker in procedure step 13 this incorporation by reference is given in above with several washes of the 170 milli- paragraph (b)(1)(i) of this section. Correct liters of isooctane, saturated with each of the maximum absorbances in the re- nitromethane, onto the top of the column. spective specified wavelength intervals by (Total volume of washes should be no greater subtracting the absorbance due to pyrene, than 10 to 15 milliliters.) Permit isooctane determined as follows: solution to enter the silica gel bed until the liquid level is at the top bed level. Place the Cp × Sa remaining amount of the 170 milliliters of Absorbance due to pyrene = isooctane, saturated with nitromethane, in Sp the reservoir above the bed for percolation through the silica gel. Apply nitrogen pres- where: sure to the top of the column, adjusting the Cp=Calculated concentration of pyrene in pressure so that the isooctane is collected at sample solution; the rate of 2.5 to 3.5 milliliters per minute, Sp=Concentration of pyrene reference stand- and percolate isooctane through the bed ard solution in same units of concentra- until a quantity of 75.0 milliliters of eluate is tion; collected. Discard the 75 milliliters of eluate. Sa=Absorbance of pyrene reference standard Turn off the stopcock and add 250 milliliters solution at wavelength of maximum ab- of benzene to the reservoir above the bed. sorbance of sample solution in the respec- Use a 400-milliliter beaker to collect the re- maining eluate. tive specified wavelength intervals. 17. Open the stopcock, renew the pressure, Also calculate the pyrene content of the and percolate the remaining isooctane and oil sample in parts per million as follows: benzene through the column eluting the re- maining aromatics. Transfer the eluate in Pyrene content (/200 1000 )× C = = 10C small portions from the 400 milliliter beaker (p.p.m.) to a 150-milliliter beaker containing 1 milli- 20/ 1000 liter of n-hexadecane and evaporate on the where: steam bath under nitrogen. Rinse the 400- C=Calculated concentration of pyrene in mil- milliliter beaker well with small portions of ligrams per liter of sample solution. isooctane to obtain a complete transfer. c. The pyrene content so determined shall (NOTE: Complete removal of the nitromethane and benzene is essential. This not exceed 25 p.p.m. The maximum can be assured by successive additions of 5 absorbances corrected for pyrene content as milliliters of isooctane and reevaporation.) described in this step 19 for each of the speci- 18. Transfer the residue with several wash- fied wavelength intervals shall not exceed es of isooctane into a 200-milliliter volu- the limits prescribed in paragraph (d)(1)(ii) metric flask. Add isooctane to mark. of this section. 19. Record the spectrum of the sample solu- d. If the spectrum as a whole of the sample tion in a 1-centimeter cell compared to iso- solution is in any respect clearly incompat- octane from 270 to 400 mµ. After making nec- ible with the presence of pyrene as the essary corrections in the spectrum for cell source of the peak at 334 mµ, then the max- differences and for the blank absorbance, imum absorbances in the respective wave- record the maximum absorbance in each of length intervals without correction for any the wavelength intervals (mµ), 280–299, 300– assumed pyrene content shall not exceed the 319, 320–359, 360–400. limits prescribed in paragraph (d)(1)(ii) of a. If the spectrum then shows no discern- this section. ible peak corresponding to the absorbance maximum of the pyrene reference standard [42 FR 14609, Mar. 15, 1977, as amended at 47 solution at 334 mµ, the maximum FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, absorbances in the respective wavelength in- 1984; 54 FR 24898, June 12, 1989]
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§ 178.3650 Odorless light petroleum hy- (2) Initial boiling point is 300 °F min- drocarbons. imum. (3) Final boiling point is 650 °F max- Odorless light petroleum hydro- imum. carbons may be safely used, as a com- (4) Ultraviolet absorbance limits de- ponent of nonfood articles intended for termined by method specified in use in contact with food, in accordance § 178.3620(b)(1)(ii), as follows: with the following prescribed condi- tions: Maximum (a) The additive is a mixture of liquid absorb- Wavelength (Mµ) ance per hydrocarbons derived from petroleum centimeter optical or synthesized from petroleum gases. pathlength The additive is chiefly paraffinic, 280 to 289 ...... 4.0 isoparaffinic, or naphthenic in nature. 290 to 299 ...... 3.3 (b) The additive meets the following 300 to 329 ...... 2.3 specifications: 330 to 360 ...... 8 (1) Odor is faint and not kerosenic. (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- Test Method for Dropping Point of Lu- arate. bricating Grease,’’ which is incor- Pentaerythritol adipate-stearate porated by reference. Copies may be identified in paragraph (a) of this sec- obtained from the American Society tion may be safely used as a lubricant for Testing Materials, 1916 Race St., in the fabrication of rigid and semi- Philadelphia, PA 19103, or may be ex- rigid polyvinyl chloride and/or vinyl amined at the Office of the Federal chloride-propylene copolymers com- Register, 800 North Capitol Street, plying with § 177.1980 of this chapter NW., suite 700, Washington, DC 20408. used as articles or components of arti- (2) Acid value not to exceed 15 as de- cles that contact food, excluding food termined by ASTM method D1386–78, with alcohol content greater than 8 ‘‘Standard Test Method for Saponifica- percent under conditions of use of E, F, tion Number (Empirical) of Synthetic and G described in table 2 in § 175.300(d) and Natural Waxes’’ (Revised 1978), of this chapter, subject to the provi- which is incorporated by reference. sions of this section. Copies are available from American So- (a) Identity. For the purpose of this ciety for Testing and Materials section, pentaerythritol adipate-stea- (ASTM), 1916 Race Street, Philadel- rate is an ester of pentaerythritol with phia, PA 19103, or available for inspec- adipic acid and stearic acid and its as- tion at the Office of the Federal Reg- sociated fatty acids (chiefly palmitic), ister, 800 North Capitol Street, NW., with adipic acid comprising 14 percent suite 700, Washington, DC 20408. and stearic acid and its associated (3) Saponification number of 270–280 acids (chiefly palmitic) comprising 71 as determined by ASTM method D1387– percent of the organic moieties. 78, ‘‘Standard Test Method for Acid (b) Specifications. Pentaerythritol adi- Number (Empirical) of Synthetic and pate-stearate has the following speci- Natural Waxes’’ (Revised 1978), which is fications: incorporated by reference. Copies are (1) Melting point (dropping) of 55–58 available from American Society for °C as determined by ASTM method Testing and Materials (ASTM), 1916 D566–76 (Reapproved 1982), ‘‘Standard Race Street, Philadelphia, PA 19103, or
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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. scribed by specific regulations in parts (4) Iodine number not to exceed 2 as 175, 176, 177, and 178 of this chapter determined by Iodine Absorption Num- which prescribe uses of petrolatum. ber, Hanus Method, of the ‘‘Official For the purpose of cross-reference, Methods of Analysis of the Association such specific regulations include: of Official Analytical Chemists,’’ sec- §§ 175.105, 175.125, 175.300, 176.170, 176.200, tions 28.018–28.019, 13th Ed. (1980), which 176.210, 177.2600, 177.2800, and 178.3570 of is incorporated by reference. Copies this chapter. may be obtained from the Association (e) Petrolatum may contain any anti- of Official Analytical Chemists Inter- oxidant permitted in food by regula- national, 481 North Frederick Ave., tions issued pursuant to section 409 of suite 500, Gaithersburg, MD 20877–2504, the act, in an amount not greater than or may be examined at the Office of the that required to produce its intended Federal Register, 800 North Capitol effect. Street, NW., suite 700, Washington, DC [42 FR 14609, Mar. 15, 1977, as amended at 49 20408. FR 10113, Mar. 19, 1984; 55 FR 12172, Apr. 2, (c) The total amount of ester (cal- 1990] culated as free pentaerythritol) shall not exceed 0.4 percent by weight of the § 178.3710 Petroleum wax. polyvinyl chloride and/or the vinyl Petroleum wax may be safely used as chloride-propylene copolymers com- a component of nonfood articles in con- plying with § 177.1980. tact with food, in accordance with the [45 FR 1018, Jan. 4, 1980, as amended at 47 FR following conditions: 11848, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984; (a) Petroleum wax is a mixture of 54 FR 24898, June 12, 1989; 57 FR 18082, Apr. solid hydrocarbons, paraffinic in na- 29, 1992] ture, derived from petroleum, and re- fined to meet the specifications pre- § 178.3700 Petrolatum. scribed in this section. Petrolatum may be safety used as a (b) The petroleum wax meets the fol- component of nonfood articles in con- lowing ultraviolet absorbance limits tact with food, in accordance with the when subjected to the analytical proce- following conditions: dure described in § 172.886(b) of this (a) Petrolatum complies with the chapter. specifications set forth in the United Ultraviolet absorbance per centi- States Pharmacopeia XX (1980) for meter pathlength: white petrolatum or in the National Formulary XV (1980) for yellow petro- Millimicrons Maximum latum. 280 to 289 ...... 0.15 (b) Petrolatum meets the following 290 to 299 ...... 12 300 to 359 ...... 08 ultraviolet absorbance limits when 360 to 400 ...... 02 subjected to the analytical procedure described in § 172.886(b) of this chapter: (c) Petroleum wax may contain any Ultraviolet absorbance per centi- antioxidant permitted in food by regu- meter pathlength: lations issued in accordance with sec- tion 409 of the act, in an amount not Millimicrons Maximum greater than that required to produce 280 to 289 ...... 0.25 its intended effect. 290 to 299 ...... 20 (d) Petroleum wax may contain a 300 to 359 ...... 14 360 to 400 ...... 04 total of not more than 1 weight percent of residues of the following polymers (c) It is used or intended for use as a when such residues result from use of protective coating of the surfaces of the polymers as processing aids (filter metal or wood tanks used in fermenta- aids) in the production of the petro- tion process, in an amount not in ex- leum wax: Homopolymers and/or co- cess of that required to produce its in- polymers derived from one or more of tended effect. the mixed n-alkyl (C12, C14, C16, and C18)
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methacrylate esters where the C12 and § 178.3720 Petroleum wax, synthetic. C14 alkyl groups are derived from coco- Synthetic petroleum wax may be nut oil and the C16 and C18 groups are safely used in applications and under derived from tallow. the same conditions where naturally (e) Petroleum wax may contain 2-hy- derived petroleum wax is permitted in droxy-4-n-octoxybenzophenone as a sta- subchapter B of this chapter as a com- bilizer at a level not to exceed 0.01 ponent of articles intended to contact weight percent of the petroleum wax. food, provided that the synthetic petro- (f) Petroleum wax may contain leum wax meets the definition and poly(alkylacrylate) (CAS Reg. No. specifications prescribed in § 172.888 of 27029–57–8), as described in § 172.886(c)(2) this chapter. of this chapter, as a processing aid in the manufacture of petroleum wax. § 178.3725 Pigment dispersants. Subject to the provisions of this reg- [42 FR 14609, Mar. 15, 1977, as amended at 51 ulation, the substances listed in this FR 19545, May 30, 1986] section may be safely used as pigment dispersants in food-contact materials.
Substances Limitations
Dimethylolpropionic acid (CAS Reg. No. 4767Ð03Ð7) ...... 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. 68604Ð99Ð9), 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 221281Ð21Ð6). 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. 155419Ð59Ð3). 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. 77Ð85Ð0) ...... 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 § 178.3740 Plasticizers in polymeric FR 35799, July 1, 1998; 64 FR 48292, Sept. 3, substances. 1999; 64 FR 72273, Dec. 27, 1999; 65 FR 52909, Aug. 31, 2000] Subject to the provisions of this reg- ulation, the substances listed in para- § 178.3730 Piperonyl butoxide and graph (b) of this section may be safely pyrethrins as components of bags. used as plasticizers in polymeric sub- stances used in the manufacture of ar- Piperonyl butoxide in combination ticles or components of articles in- with pyrethrins may be safely used for tended for use in producing, manufac- insect control on bags that are in- turing, packing, processing, preparing, tended for use in contact with dried treating, packaging, transporting, or feed in compliance with §§ 561.310 and holding food. 561.340 of this chapter, or that are in- (a) The quantity used shall not ex- tended for use in contact with dried ceed the amount reasonably required food in compliance with §§ 193.60 and to accomplish the intended technical 193.390 of this chapter. effect. (b) List of substances:
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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 per- cent by weight of dibenzyl phthalate; and Provided further, That the fin- ished food-contact article, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and tem- perature characterizing the conditions of its intended use as determined from tables 1 and 2 of ¤ 175.300(d) of this chapter, shall yield net chloro- form-soluble extractives not to exceed 0.5 mg. per square inch, as deter- mined by the methods prescribed in ¤ 175.300(e) of this chapter. 1,3-Butylene glycoladipic acid polyester (1,700Ð 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 aver- age 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 con- tact 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 aver- age 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 hav- ing 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 aver- age 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 con- tact 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 aver- age 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. Dicyclohexyl phthalate ...... For use only: 1. As provided in ¤¤ 175.105, 176.170, 176.180, and 177.1200 of this chap- ter. 2. Alone or in combination with other phthalates, in plastic film or sheet pre- pared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride co- polymers 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.
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Substances Limitations
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, non- alcoholic 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, non- alcoholic 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, non- alcoholic 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 sub- stance 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, IVÐB, VIÐB, 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 pre- pared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride co- polymers 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. Mineral oil, white.
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Substances Limitations
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 D445Ð82 (‘‘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 D2161Ð82 (‘‘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 D1492Ð78 (‘‘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 300Ð5,000) ...... 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 pol- yethylene shall not be used as a component of articles intended for pack- ing or holding food during cooking. Polyisobutylene complying with ¤ 177.1420 of this chapter. Polypropylene glycol (CAS registry No. 25322Ð69Ð 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 plas- tic article contacts food only of the types identified in ¤ 176.170(c) of this chapter, table 1, under Categories I, II, VIÐB, VIIÐB, and VIII.
(c) The use of the plasticizers in any diethylene glycols if its mean molec- polymeric substance or article subject ular weight is 350 or higher and no to any regulation in parts 174, 175, 176, more than 0.5 percent total by weight 177, 178 and 179 of this chapter must of ethylene and diethylene glycols if its comply with any specifications and mean molecular weight is below 350, limitations prescribed by such regula- when tested by the analytical methods tion for the finished form of the sub- prescribed in § 172.820(b) of this chapter. stance or article. (c) The provisions of paragraph (b) of [42 FR 14609, Mar. 15, 1977, as amended at 42 this section are not applicable to poly- FR 44223, Sept. 2, 1977; 45 FR 56052, Aug. 22, ethylene glycols used in food-pack- 1980; 48 FR 5748, Feb. 15, 1984; 49 FR 10113, aging adhesives complying with Mar. 19, 1984; 51 FR 47011, Dec. 30, 1986] § 175.105 of this chapter.
§ 178.3750 Polyethylene glycol (mean § 178.3760 Polyethylene glycol (400) molecular weight 200–9,500). monolaurate. 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.
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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, 200 C St. SW., 1.0 milliliter of n-hexadecane to 25 milliliters Washington, DC 20204, or available for in- with isooctane and determine the absorbance spection at the Office of the Federal Reg- in a 1-centimeter cell compared to isooctane ister, 800 North Capitol Street, NW., suite as reference point between 280 mµ-400 mµ. 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 (pref- erably 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 re- peat 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, D–566–76 (Reapproved 1982), ‘‘Standard subject to the provisions of this sec- Test Method for Dropping Point of Lu- tion. bricating Grease,’’ which is incor- (a) Identity. For the purpose of this porated by reference in accordance section, polyhydric alcohol esters of with 5 U.S.C. 552(a). The availability of long chain monobasic acids consist of this incorporation by reference is given polyhydric alcohol esters having num- in paragraph (a)(1) of this section. ber average molecular weights in the (2) Acid value 20–30, as determined by range of 1,050 to 1,700. The esters are ASTM Method D–1386–78 ‘‘Standard produced by the reaction of either Test Method for Acid Number (Empir- ethylene glycol or glycerol with long ical) of Synthetic and Natural Waxes’’ chain monobasic acids containing from (Revised 1978) (which is incorporated by 9 to 49 carbon atoms obtained by the reference in accordance with 5 U.S.C. ozonization of long chain alpha-olefins, 552(a); the availability of this incorpo- the unreacted carboxylic acids in the ration by reference is given in para- formation of the glycerol esters being graph (a)(2) of this section), using as a neutralized with calcium hydroxide to solvent xylene-ethyl alcohol in a 2:1 produce a composition having up to 2 ratio instead of toluene-ethyl alcohol percent by weight calcium. The alpha- in a 2:1 ratio. olefins, obtained from the polymeriza- (3) Saponification value 130–160, as tion of ethylene, have 20 to 50 carbon determined by ASTM Method D–1387–78 atoms and contain a minimum of 75 ‘‘Standard Test Method for Saponifica- percent by weight straight chain alpha- olefins and not more than 25 percent tion Number (Empirical) of Synthetic vinylidene compounds. and Natural Waxes’’ (Revised 1978), (b) Specifications. The polyhydric al- (which is incorporated by reference in cohol esters have the following speci- accordance with 5 U.S.C. 552(a); the fications: availability of this incorporation by (1) Melting point of 60–80 °C for the reference is given in paragraph (a)(3) of ethylene glycol ester and 90–105 °C for this section), using xylene-ethyl alco- the glycerol ester as determined by the hol in a 2:1 ratio instead of ethyl alco- Fisher Johns method as described in hol in the preparation of potassium hy- ‘‘Semimicro Qualitative Organic Anal- droxide solution. ysis—The Systematic Identification of (4) Ultraviolet absorbance limits Organic Compounds,’’ by Cheronis and specified in paragraph (a)(4) of this sec- Entrikin, 2d Ed., Interscience Pub- tion, as determined by the analytical lishers, NY, which is incorporated by method described therein. reference. Copies are available from [42 FR 14609, Mar. 15, 1977, as amended at 47 the Center for Food Safety and Applied FR 11848, Mar. 19, 1982; 49 FR 10113, Mar. 19, Nutrition (HFS–200), Food and Drug 1984; 51 FR 33895, Sept. 24, 1986; 54 FR 24898, Administration, 200 C St. SW., Wash- June 12, 1989; 55 FR 28020, July 9, 1990; 58 FR ington, DC 20204, or available for in- 17512, Apr. 5, 1993] spection at the Office of the Federal
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Register, 800 North Capitol Street, more of the monomers listed in para- NW., suite 700, Washington, DC 20408. graph (a)(1)(i) of this section. (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 inspec- tion 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. (4) Ultraviolet absorbance as speci- Methacrylic acid. fied 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
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(2) Not less than 50 weight-percent of § 176.170(c) of this chapter, yields ex- polymer units derived from the vinyl tractives not to exceed the limits pre- chloride polymers identified in the in- scribed in § 177.1010 (b) (1), (2), (3), and troduction to this section, not more (4) of this chapter when tested by the than 50 weight-percent of polymer methods prescribed in § 177.1010 (c) of units derived from homopolymers and/ this chapter. or copolymers of ethyl acrylate and (e) Acrylonitrile copolymers identi- methyl methacrylate, and not more fied in this section shall comply with than 30 weight-percent of polymer the provisions of § 180.22 of this chap- units derived from copolymers of meth- ter. yl methacrylate, a-methylstyrene and acrylonitrile and may optionally con- § 178.3800 Preservatives for wood. tain up to 15 weight-percent of polymer units derived from butadiene-styrene Preservatives may be safely used on copolymers. wooden articles that are used or in- (c) No chemical reactions, other than tended for use in packaging, trans- addition reactions, occur among the porting, or holding raw agricultural vinyl chloride polymers and the modi- products subject to the provisions of fying polymers present in the polymer this section: mixture used in the manufacture of the (a) The preservatives are prepared finished plastic food-contact article. from substances identified in para- (d) The finished plastic food-contact graph (b) of this section and applied in article, when extracted with the sol- amounts not to exceed those necessary vent or solvents characterizing the to accomplish the technical effect of type of food and under the conditions protecting the wood from decay, mil- of time and temperature characterizing dew, and water absorption. the conditions of its intended use as de- (b) The substances permitted are as termined from tables 1 and 2 of 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 lim- Reinforced wax may be safely used as itation provided in this section. an article or component of articles in- (c) Any substance employed in the tended for use in producing, manufac- production of reinforced wax, including turing, packing, processing, trans- any optional substance, that is the sub- porting, or holding food subject to the ject of a regulation in parts 174, 175, provisions of this section. 176, 177, 178 and § 179.45 of this chapter, (a) Reinforced wax consists of petro- conforms with any specification in leum wax to which have been added such regulation. certain optional substances required in (d) The substances and optional adju- its production, or added to impart de- vant substances employed in the pro- sired physical or technical properties. duction of or added to reinforced wax (b) The quantity of any optional ad- include: juvant substance employed in the pro- (1) Substances generally recognized duction of or added to reinforced wax as safe in food. 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 modi- fied 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. 25359Ð91Ð5). 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 concentra- tion 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. 70892Ð21Ð6) 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 alco- hol/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 vege- table 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 spection 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, 200 C St. SW., Wash- (2) Substances identified in this para- ington, DC 20204, or available for in- graph.
List of substances Limitations
α-Butyl-Ω-hydroxypoly (oxyethylene)-poly (oxypropylene) (CAS Reg. No. 9038Ð95Ð3) 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. αÐButylÐΩÐhydroxypoly(oxypropylene) (CAS Reg. No. 9003- 13Ð8) having a minimum molecular weight of 1000. αÐLauroylÐΩÐhydroxpoly(oxyethylene) (CAS Reg. No. 9004Ð 81Ð3) 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. alphaÐAlkylÐomegaÐhydroxypoly(oxyethylene) produced by the condensation of 1 mole of C12¥C15 straight chain primary al- cohols with an average of 3 moles of ethylene oxide (CAS Reg. No. 6002Ð97Ð1). Benzotriazole (CAS Reg. No. 95Ð14Ð7) ......
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List of substances Limitations
Bis(hydrogenated tallow alkyl)amine (CAS Reg. No. 61789Ð Not to be used in combination with sodium nitrite. 79Ð5). Bis(hydrogenated tallow alkyl)aminoethanol (CAS Reg. No. 116438Ð56Ð3). N,N-Bis(2-hydroxyethyl)butylamine (CAS Reg. No. 102Ð79Ð4) Tert-Butyl alcohol. Di(2-ethylhexyl)phthalate. Diethyl phthalate. Diethylene glycol monobutylether (CAS Reg. No. 112Ð34Ð5) .... 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 180Ð200, acid value 70Ð130, and max- imum iodine value 120. Di-n-octyl sebacate. Ethylenediaminetetraacetic acid, sodium salts. Isopropyl alcohol. Isopropyl laurate (CAS Reg. No. 10233Ð13Ð3) ...... 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. 9043Ð30Ð5). 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 pre- scribed under ¤ 178.3740(b). Polyethylene glycol (400) monostearate. Polyisobutylene (minimum molecular weight 300). Polyoxyethylated (5 moles) tallow amine (CAS Reg. No. 61791Ð26Ð2). Polyvinyl alcohol. Sodium nitrite ...... For use only as a rust inhibitor in lubricant formulations pro- vided 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 440Ð450 (CAS Reg. No. 68608Ð24Ð4) derived from naphthenic oil having a Saybolt viscosity range of 500Ð600 Saybolt Universal Seconds (SUS at 37Ð8 °C (100 °F) as determined by ASTM method D88Ð 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 alco- hols that have even numbers of carbon atoms in the range C4–C18 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 alco- hols and contains not less than 85 pct total C10 and C12 al- cohols. 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 alco- hols; 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 frac- tion, 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, 266Ð276. 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 mon- oxide and hydrogen using a modified oxo process, such that the finished primary alcohol mixture meets the following specifications: Molecular weight 194±5; hydroxyl number, 283Ð296.
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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 fol- lowing specifications: 280Ð289 ...... 0.7 (a) Initial boiling point is 24 °C min- 290Ð299 ...... 6 300Ð359 ...... 4 imum and final boiling point is 288 °C 360Ð400 ...... 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-milli- liter, 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 specifica- tions 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 evapo- ration 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 200 C St. SW., Washington, DC 20204, or avail- with successive 15-milliliter portions of the able for inspection at the Office of the Fed- indicated solvent until a 15-milliliter portion eral Register, 800 North Capitol Street, NW., of the wash shows 0.00 absorbance per centi- suite 700, Washington, DC 20408. The accu- meter path length between 280 mµ and 400 mµ racy is to be determined by comparison with when tested as prescribed under ‘‘Organic the standard values at 210, 345, and 400 milli- solvents.’’ Usually three portions of wash microns. 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 mil- liliters 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 iso- octane 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 sub- paragraph.
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 chap- ter. Dipropylene glycol. Epoxidized soybean oil ...... Conforming to the identity prescribed in ¤ 181.27 of this chap- ter. 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. 80939Ð62Ð4). 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. 6683Ð19Ð8). 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 (c) Packaging materials subjected to from operation of the tube source at a irradiation incidental to the radiation voltage of 500 kilovolt peak or lower. treatment and processing of pre- (2) Sealed units producing radiations packaged foods shall comply with at energy levels of not more than 2.2 § 179.45. million electron volts from one of the (d) Radiation treatment of food shall following isotopes: Americium-241, ce- conform to a scheduled process. A sium-137, cobalt-60, iodine-125, krypton- scheduled process for food irradiation 85, radium-226, and strontium-90. is a written procedure that ensures (3) Sealed units producing neutron that the radiation dose range selected radiation from the isotope Califor- by the food irradiation processor is nium-252 (CAS Reg. No. 13981–17–4) to adequate under commercial processing measure moisture in food. conditions (including atmosphere and (b) To assure safe use of these radi- temperature) for the radiation to ation sources: achieve its intended effect on a specific (1) The label of the sources shall product and in a specific facility. A bear, in addition to the other informa- food irradiation processor shall operate tion required by the Act: with a scheduled process established by (i) Appropriate and accurate informa- qualified persons having expert knowl- tion identifying the source of radi- edge in radiation processing require- ation. ments of food and specific for that food (ii) The maximum energy of radi- and for that irradiation processor’s ation emitted by X-ray tube sources. treatment facility. (2) The label or accompanying label- (e) A food irradiation processor shall ing shall bear: maintain records as specified in this (i) Adequate directions for installa- section for a period of time that ex- tion and use. ceeds the shelf life of the irradiated (ii) A statement that no food shall be food product by 1 year, up to a max- exposed to radiation sources listed in imum of 3 years, whichever period is paragraph (a) (1) and (2) of this section shorter, and shall make these records so as to receive an absorbed dose in ex- available for inspection and copy by cess of 10 grays. authorized employees of the Food and (iii) A statement that no food shall Drug Administration. Such records be exposed to a radiation source listed shall include the food treated, lot iden- in paragraph (a)(3) of this section so as tification, scheduled process, evidence to receive an absorbed dose in excess of of compliance with the scheduled proc- 2 milligrays. ess, ionizing energy source, source cali- bration, dosimetry, dose distribution in [42 FR 14635, Mar. 15, 1977, as amended at 48 FR 46022, Oct. 11, 1983; 61 FR 14246, Apr. 1, the product, and the date of irradia- 1996; 64 FR 69191, Dec. 10, 1999] tion. (Approved by the Office of Management and § 179.25 General provisions for food ir- Budget under control number 0910–0186) radiation. For the purposes of § 179.26, current [51 FR 13399, Apr. 18, 1986] good manufacturing practice is defined § 179.26 Ionizing radiation for the to include the following restrictions: treatment of food. (a) Any firm that treats foods with ionizing radiation shall comply with Ionizing radiation for treatment of the requirements of part 110 of this foods may be safely used under the fol- chapter and other applicable regula- lowing conditions: tions. (a) Energy sources. Ionizing radiation (b) Food treated with ionizing radi- is limited to: ation shall receive the minimum radi- (1) Gamma rays from sealed units of ation dose reasonably required to ac- the radionuclides cobalt-60 or cesium- complish its intended technical effect 137. and not more than the maximum dose (2) Electrons generated from machine specified by the applicable regulation sources at energies not to exceed 10 for that use. million electron volts.
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(3) X-rays generated from machine Use Limitations sources at energies not to exceed 5 mil- 7. For the sterilization of frozen, pack- Minimum dose 44 lion electron volts. aged meats used solely in the Na- kGy (4.4 Mrad). (b) Limitations. tional Aeronautics and Space Admin- Packaging mate- istration space flight programs. rials used need Use Limitations not comply with ¤ 179.25(c) pro- 1. For control of Trichinella spiralis in Minimum dose 0.3 vided that their pork carcasses or fresh, non-heat- kiloGray (kGy) use is otherwise processed cuts of pork carcasses. (30 kilorad permitted by ap- (krad)); maximum plicable regula- dose not to ex- tions in parts 174 ceed 1 kGy (100 through 186 of krad). this chapter. 2. For growth and maturation inhibition Not to exceed 1 8. For control of foodborne pathogens Not to exceed 4.5 of fresh foods. kGy (100 krad). in, and extension of the shelf-life of, kGy maximum 3. For disinfestation of arthropod pests Do. refrigerated or frozen, uncooked for refrigerated in food. products that are meat within the products; not to 4. For microbial disinfection of dry or Not to exceed 10 meaning of 9 CFR 301.2(rr), meat exceed 7.0 kGy dehydrated enzyme preparations (in- kGy (1 megarad byproducts within the meaning of 9 maximum for fro- cluding immobilized enzymes). (Mrad)). CFR 301.2(tt), or meat food products zen products. 5. For microbial disinfection of the fol- Not to exceed 30 within the meaning of 9 CFR lowing dry or dehydrated aromatic kGy (3 Mrad). 301.2(uu), with or without nonfluid vegetable substances when used as seasoning, that are otherwise com- ingredients in small amounts solely posed solely of intact or ground for flavoring or aroma: culinary herbs, meat, meat byproducts, or both meat seeds, spices, vegetable seasonings and meat byproducts. that are used to impart flavor but that 9. For control of Salmonella in fresh Not to exceed 3.0 are not either represented as, or ap- shell eggs.. kGy. pear to be, a vegetable that is eaten for its own sake, and blends of these 10. For control of microbial pathogens Not to exceed 8.0 aromatic vegetable substances. Tur- on seeds for sprouting.. kGy. meric and paprika may also be irradi- ated when they are to be used as (c) Labeling. (1) The label and label- color additives. The blends may con- ing of retail packages of foods irradi- tain sodium chloride and minor amounts of dry food ingredients ordi- ated in conformance with paragraph (b) narily used in such blends. of this section shall bear the following 6. For control of food-borne pathogens Not to exceed 3 in fresh or frozen, uncooked poultry kGy (300 krad); logo along with either the statement products that are: (1) Whole car- any packaging casses or disjointed portions of such used shall not carcasses that are ‘‘ready-to-cook exclude oxygen. poultry’’ within the meaning of 9 CFR 381.1(b)(44), or (2) mechanically sep- arated poultry product (a finely comminuted ingredient produced by the mechanical deboning of poultry carcasses or parts of carcasses).
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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 ‘‘Treat- length of 253.7 nanometers (2,537 ed with radiation—do not irradiate Angstroms). again’’ or the statement ‘‘Treated by (b) The ultraviolet radiation is used irradiation—do not irradiate again’’ or intended for use as follows:
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 microorga- nisms.
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[42 FR 14635, Mar. 15, 1977, as amended at 65 (4) Polyolefin film prepared from one FR 71057, Nov. 29, 2000] or more of the basic olefin polymers complying with § 177.1520 of this chap- § 179.41 Pulsed light for the treatment ter. The finished film may contain: of food. (i) Adjuvant substances used in com- Pulsed light may be safely used for pliance with §§ 178.3740 and 181.22 treatment of foods under the following through 181.30 of this chapter, sodium conditions: citrate, sodium lauryl sulfate, poly- (a) The radiation sources consist of vinyl chloride, and materials as listed xenon flashlamps designed to emit in paragraph (d)(2)(i) of this section. broadband radiation consisting of (ii) Coatings comprising a vinylidene wavelengths covering the range of 200 chloride copolymer containing a min- to 1,100 nanometers (nm), and operated imum of 85 percent vinylidene chloride so that the pulse duration is no longer with one or more of the following co- than 2 milliseconds (msec); monomers: Acrylic acid, acrylonitrile, (b) The treatment is used for surface itaconic acid, methyl acrylate, and microorganism control; methyl methacrylate. (c) Foods treated with pulsed light (5) Kraft paper prepared from un- shall receive the minimum treatment bleached sulfate pulp to which rosin, reasonably required to accomplish the complying with § 178.3870 of this chap- intended technical effect; and ter, and alum may be added. The kraft (d) The total cumulative treatment paper is used only as a container for shall not exceed 12.0 Joules/square cen- flour and is irradiated with a dose not timeter (J/cm2.) exceeding 500 grays. [61 FR 42383, Aug. 15, 1996] (6) Polyethylene terephthalate film prepared from the basic polymer as de- Subpart C—Packaging Materials scribed in § 177.1630(e)(4)(i) and (ii) of for Irradiated Foods this chapter. The finished film may contain: § 179.45 Packaging materials for use (i) Adjuvant substances used in com- during the irradiation of pre- pliance with §§ 178.3740 and 181.22 packaged foods. through 181.30 of this chapter, sodium The packaging materials identified citrate, sodium lauryl sulfate, poly- in this section may be safely subjected vinyl chloride, and materials as listed to irradiation incidental to the radi- in paragraph (d)(2)(i) of this section. ation treatment and processing of pre- (ii) Coatings comprising a vinylidene packaged foods, subject to the provi- chloride copolymer containing a min- sions of this section and to the require- imum of 85 percent vinylidene chloride ment that no induced radioactivity is with one or more of the following co- detectable in the packaging material monomers: Acrylic acid, acrylonitrile, itself: itaconic acid, methyl acrylate, and (a) The radiation of the food itself methyl methacrylate. shall comply with regulations in this (iii) Coatings consisting of poly- part. ethylene conforming to § 177.1520 of this (b) The following packaging mate- chapter. rials may be subjected to a dose of ra- (7) Polystyrene film prepared from diation, not to exceed 10 kilograys, un- styrene basic polymer. The finished less otherwise indicated, incidental to film may contain adjuvant substances the use of gamma, electron beam, or X- used in compliance with §§ 178.3740 and radiation in the radiation treatment of 181.22 through 181.30 of this chapter. prepackaged foods: (8) Rubber hydrochloride film pre- (1) Nitrocellulose-coated or vinyli- pared from rubber hydrochloride basic dene chloride copolymer-coated cello- polymer having a chlorine content of phane complying with § 177.1200 of this 30–32 weight percent and having a max- chapter. imum extractable fraction of 2 weight (2) Glassine paper complying with percent when extracted with n-hexane § 176.170 of this chapter. at reflux temperature for 2 hours. The (3) Wax-coated paperboard complying finished film may contain adjuvant with § 176.170 of this chapter. substances used in compliance with
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§§ 178.3740 and 181.22 through 181.30 of packaging materials may be subjected this chapter. to a dose of radiation, not to exceed 30 (9) Vinylidene chloride-vinyl chloride kilogray (3 megarads), incidental to copolymer film prepared from vinyli- the use of gamma, electron beam, or X- dene chloride-vinyl chloride basic co- radiation in the radiation treatment of polymers containing not less than 70 packaged foods. weight percent of vinylidene chloride (d) The following packaging mate- and having a viscosity of 0.50–1.50 cen- rials may be subjected to a dose of ra- tipoises as determined by ASTM meth- diation, not to exceed 60 kilograys inci- od D729–81, ‘‘Standard Specification for dental to the use of gamma, electron Vinylidene Chloride Molding Com- beam, or X-radiation in the radiation pounds,’’ which is incorporated by ref- processing of prepackaged foods: erence. Copies may be obtained from (1) Vegetable parchments, consisting the American Society for Testing Ma- terials, 1916 Race St., Philadelphia, PA of a cellulose material made from 19103, or may be examined at the Office waterleaf paper (unsized) treated with of the Federal Register, 800 North Cap- concentrated sulfuric acid, neutralized, itol Street, NW., suite 700, Washington, and thoroughly washed with distilled DC 20408. The finished film may con- water. tain adjuvant substances used in com- (2) Films prepared from basic poly- pliance with §§ 178.3740 and 181.22 mers and with or without adjuvants, as through 181.30 of this chapter. follows: (10) Nylon 11 conforming to § 177.1500 (i) Polyethylene film prepared from of this chapter. the basic polymer as described in (c) Ethylene-vinyl acetate copoly- § 177.1520(a) of this chapter. The fin- mers complying with § 177.1350 of this ished film may contain one or more of chapter. The ethylene-vinyl acetate 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 10.0 to 11.5 weight percent of vinyl ace- prepared from the basic polymer as de- tate and having a maximum volatility scribed in § 177.1630(e)(4)(ii) of this of not over 3.0 percent (1 hour at 105 °C) chapter. The finished film may contain and viscosity not less than 0.30 deter- one or more of the added substances mined by ASTM method D1243–79, listed in paragraph (d)(2)(i) of this sec- ‘‘Standard Test Method for Dilute So- tion. lution Viscosity of Vinyl Chloride (iii) Nylon 6 films prepared from the Polymers,’’ Method A, which is incor- nylon 6 basic polymer as described in porated by reference. The availability § 177.1500(a)(6) of this chapter and meet- of this incorporation by reference is ing the specifications of item 6.1 of the given in paragraph (b)(9) of this sec- table in § 177.1500(b) of this chapter. tion. The finished film may contain The finished film may contain one or one or more of the added substances more of the added substances listed in paragraph (d)(2)(i) of this section. listed in paragraph (d)(2)(i) of this sec- (iv) Vinyl chloride-vinyl acetate co- tion. polymer film prepared from the basic (e) Acrylonitrile copolymers identi- copolymer containing 88.5 to 90.0 fied in this section shall comply with weight percent of vinyl chloride with
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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 FR 10113, Mar. 19, 1984; 54 FR 7405, Feb. 21, (c) The Commissioner, on his own ini- 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 MITTED IN FOOD OR IN CON- regulation shall provide that continued 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 Sec. the circumstances. 180.1 General. (2) Within 60 days following the effec- 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. 180.30 Brominated vegetable oil. been undertaken, or the Food and Drug 180.37 Saccharin, ammonium saccharin, cal- Administration may undertake the cium saccharin, and sodium saccharin. studies. The Commissioner may extend this 60-day period if necessary to re- AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371; 42 U.S.C. 241. view and act on proposed protocols. If 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- diately be published in the FEDERAL Subpart A—General Provisions REGISTER revoking the interim food ad- ditive regulation effective upon publi- § 180.1 General. cation. (a) Substances having a history of (3) A progress report shall be filed on use in food for human consumption or the studies every January 1 and July 1 in food contact surfaces may at any until completion. If the progress report time have their safety or functionality is inadequate or if the Commissioner brought into question by new informa- concludes that the studies are not tion that in itself is not conclusive. An being pursued promptly and diligently interim food additive regulation for or if interim results indicate a reason- the use of any such substance may be able likelihood that a health hazard ex- promulgated in this subpart when new ists, an order will promptly be pub- information raises a substantial ques- lished in the FEDERAL REGISTER revok- tion about the safety or functionality ing the interim food additive regula- of the substance but there is a reason- tion effective upon publication. able certainty that the substance is (4) If nonclinical laboratory studies not harmful and that no harm to the are involved, studies filed with the public health will result from the con- Commissioner shall include, with re- tinued use of the substance for a lim- spect to each study, either a statement ited period of time while the question that the study has been or will be con- raised is being resolved by further ducted in compliance with the good study. laboratory practice regulations as set (b) No interim food additive regula- forth in part 58 of this chapter, or, if tion may be promulgated if the new in- any such study was not conducted in formation is conclusive with respect to compliance with such regulations, a the question raised or if there is a rea- brief statement of the reason for the sonable likelihood that the substance noncompliance.
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(5) [Reserved] hibited substance may be made in part (6) If clinical investigations involving 189 of this chapter when appropriate. 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, each investigation, a statement that Feb. 27, 1981; 50 FR 7492, Feb. 22, 1985; 54 FR the investigation either was conducted 39634, Sept. 27, 1989] 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- ance with §§ 56.104 or 56.105, and that it § 180.22 Acrylonitrile copolymers. 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 arti- formed consent set forth in part 50 of cles or components of articles intended this chapter. for use in contact with food, in accord- (d) Promptly upon completion of the ance with the following prescribed con- studies undertaken on the substance, ditions: the Commissioner will review all avail- (a) Limitations for acrylonitrile able data, will terminate the interim monomer extraction for finished food- food additive regulation, and will ei- contact articles, determined by a ther issue a food additive regulation or method of analysis titled ‘‘Gas-Solid will require elimination of the sub- Chromatographic Procedure for Deter- stance from the food supply. mining Acrylonitrile Monomer in Ac- (e) The Commissioner may consult rylonitrile-Containing Polymers and with advisory committees, professional Food Simulating Solvents,’’ which is organizations, or other experts in the incorporated by reference. Copies are field, in evaluating: available from the Center for Food Safety and Applied Nutrition (HFS– (1) Whether an interim food additive 200), Food and Drug Administration, regulation is justified, 200 C St. SW., Washington, DC 20204, or (2) The type of studies necessary and available for inspection at the Office of appropriate to resolve questions raised the Federal Register, 800 North Capitol about a substance, Street, NW., suite 700, Washington, DC (3) Whether interim results indicate 20408, are as follows: the reasonable likelihood that a health (1) In the case of single-use articles hazard exists, or having a volume to surface ratio of 10 (4) Whether the data available at the milliliters or more per square inch of conclusion of those studies justify a food contact surface—0.003 milligram/ food additive regulation. square inch when extracted to equi- (f) Where appropriate, an emergency librium at 120 °F with food-simulating action level may be issued for a sub- solvents appropriate to the intended stance subject to paragraph (a) of this conditions of use. section that is not an approved food ad- (2) In the case of single-use articles ditive, pending the issuance of a final having a volume to surface ratio of less interim food additive regulation. Such than 10 milliliters per square inch of an action level shall be issued pursuant food contact surface—0.3 part per mil- to sections 306 and 402(a) of the act to lion calculated on the basis of the vol- identify, based upon available data, a ume of the container when extracted to safe level of use for the substance. equilibrium at 120 °F with food-simu- Such an action level shall be issued in lating solvents appropriate to the in- a notice published in the FEDERAL REG- tended conditions of use. ISTER and shall be followed as soon as (3) In the case of repeated-use arti- practicable by a proposed interim food cles—0.003 milligram/square inch when additive regulation. Where the avail- extracted at a time equivalent to ini- able data do not permit establishing an tial batch usage utilizing food-simu- action level for the safe use of a sub- lating solvents and temperatures ap- stance, use of the substance may be propriate to the intended conditions of prohibited. The identification of a pro- use.
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The food-simulating solvents shall in- (1) Qualitative and quantitative mi- clude, where applicable, distilled gration values at a time equivalent to water, 8 percent or 50 percent ethanol, initial batch usage, utilizing solvents 3 percent acetic acid, and either n- and temperatures appropriate to the heptane or an appropriate oil or fat. intended conditions of use. (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 100 percent migration of the acrylo- Such testing shall include determina- nitrile component may be submitted in tion of the rate of decomposition of the lieu of the requirements of paragraphs complex at temperatures of 100 °F, 160 (a), (b), and (c) of this section in sup- °F, and 212 °F using 3 percent acetic port of the continued safe use of acry- acid as the hydrolic agent. Acrylo- lonitrile copolymers. nitrile monomer levels, acrylonitrile/ (e) On or before September 13, 1976, mercaptan complex levels, acrylo- any interested person shall satisfy the nitrile oligomer levels, descriptions of Commissioner of Food and Drugs that the analytical methods used to deter- toxicological feeding studies adequate mine the complex and the acrylonitrile and appropriate to establish safe condi- migration, and validation studies of tions for the use of acrylonitrile co- these analytical methods shall be sub- polymers have been, or soon will be, mitted by June 9, 1977, to the Center undertaken. Toxicity studies of acrylo- for Food Safety and Applied Nutrition nitrile monomer shall include: (1) Life- (HFS–200), Food and Drug Administra- time feeding studies with a mamma- tion, 200 C St. SW., Washington, DC lian species, preferably with animals 20204, unless an extension is granted by exposed in utero to the chemical, (2) the Food and Drug Administration for studies of multigeneration reproduc- good cause shown. Analytical methods tion with oral administration of the for the determination of acrylonitrile test material, (3) assessment of complexes with n-dodecyl-mercaptan, teratogenic and mutagenic potentials, n-octyl mercaptan, and 2- (4) subchronic oral administration in a mercaptoethanol, titled ‘‘Determina- nonrodent mammal, (5) tests to deter- tion of β-Dodecyl- mine any synergistic toxic effects be- mercaptopropionitrile in NR–16R Aque- tween acrylonitrile monomer and cya- ous Extracts’’ and ‘‘Measurement of β- nide ion, and (6) a literature search on (2-Hdroxyethylmercapto) Propionitrile the effects of chronic ingestion of hy- in Heptane Food-Simulating Solvent,’’ drogen cyanide. Data on levels of acryl- are incorporated by reference. Copies amide extractable from acrylonitrile are available from the Center for Food copolymers shall also be submitted. Safety and Applied Nutrition (HFS– Protocols of testing should be sub- 200), Food and Drug Administration, mitted for review to the Center for 200 C St. SW., Washington, DC 20204, or Food Safety and Applied Nutrition available for inspection at the Office of (HFS–200, Food and Drug Administra- the Federal Register, 800 North Capitol tion, 200 C St. SW., Washington, DC Street, NW., suite 700, Washington, DC 20204. 20408. (f) Acrylonitrile copolymers may be (c) The following data shall be pro- used in contact with food only if au- vided for finished food-contact articles thorized in parts 174 through 179 or intended for repeated use: § 181.32 of this chapter, except that
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other uses of acrylonitrile copolymers bitol principally by having a different in use prior to June 14, 1976, may con- optical rotation. Mannitol is produced tinue under the following conditions: by one of the following processes: (1) On or before August 13, 1976, each (1) The electrolytic reduction or use of acrylonitrile copolymers in a transition metal catalytic hydro- manner not authorized by § 181.32 of genation of sugar solutions containing this chapter or parts 174 through 179 of glucose or fructose. this chapter shall be the subject of a (2) The fermentation of sugars or notice to the Center for Food Safety sugar alcohols such as glucose, sucrose, and Applied Nutrition (HFS–200), Food fructose, or sorbitol using the yeast and Drug Administration, 200 C St. Zygosaccharomyces rouxii. SW., Washington, DC 20204. Such notice (b) The ingredient meets the speci- shall be accompanied by a statement of fications of the ‘‘Food Chemicals the basis, including any articles and Codex,’’ 3d Ed. (1981), pp. 188–190, which correspondence, on which the user in good faith believed the use to be prior- is incorporated by reference. Copies sanctioned. The Commissioner of Food may be obtained from the National Academy Press, 2101 Constitution Ave. and Drugs shall, by notice in the FED- NW., Washington, DC 20418, or may be ERAL REGISTER, identify any use of ac- rylonitrile copolymers not in accord- examined at the Office of the Federal ance with this paragraph. Those uses Register, 800 North Capitol Street, are thereafter unapproved food addi- NW., suite 700, Washington, DC 20408. tives and consequently unlawful. (c) The ingredient is used as an (2) Any use of acrylonitrile copoly- anticaking agent and free-flow agent as mers subject to paragraph (f)(1) of this defined in § 170.3(o)(1) of this chapter, section shall be the subject of a peti- formulation aid as defined in § 170.3(o) tion submitted on or before December (14) of this chapter, firming agent as 13, 1976, in accordance with § 171.1 of defined in § 170.3(o)(10) of this chapter, this chapter, unless an extension of flavoring agent and adjuvant as defined time is granted by the Food and Drug in § 170.3(o)(12) of this chapter, lubri- Administration for good cause shown. cant and release agent as defined in Any application for extension shall be § 170.3(o)(18) of this chapter, nutritive by petition submitted in accordance sweetener as defined in § 170.3(o)(21) of with the requirements of part 10 of this this chapter, processing aid as defined chapter. If a petition is denied, in in § 170.3(o)(24) of this chapter, sta- whole or in part, those uses subject to bilizer and thickener as defined in the denial are thereafter unapproved § 170.3(o)(28) of this chapter, surface-fin- food additives and consequently unlaw- ishing agent as defined in § 170.3(o)(30) ful. of this chapter, and texturizer as de- (3) Any use of acrylonitrile copoly- fined in § 170.3(o)(32) of this chapter. mers subject to paragraph (f)(1) of this (d) The ingredient is used in food at section shall meet the acrylonitrile levels not to exceed 98 percent in monomer extraction limitation set pressed mints and 5 percent in all other forth in paragraph (a) of this section hard candy and cough drops as defined and shall be subject to the require- in § 170.3(n)(25) of this chapter, 31 per- ments of paragraph (b) of this section. cent in chewing gum as defined in (g) In addition to the requirements of § 170.3(n)(6) of this chapter, 40 percent this section, the use of acrylonitrile co- in soft candy as defined in § 170.3(n)(38) polymers shall comply with all applica- of this chapter, 8 percent in confections ble requirements in other regulations and frostings as defined in § 170.3(n)(9) in this part. of this chapter, 15 percent in non- [42 FR 14636, Mar. 15, 1977, as amended at 47 standardized jams and jellies, commer- FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, cial, as defined in § 170.3(n)(28) of this 1989; 61 FR 14246, Apr. 1, 1996] chapter, and at levels less than 2.5 per- cent in all other foods. § 180.25 Mannitol. (e) The label and labeling of food (a) Mannitol is the chemical whose reasonably foreseeable consump- 1,2,3,4,5,6,-hexanehexol (C6H14O6) a tion may result in a daily ingestion of hexahydric alcohol, differing from sor- 20 grams of mannitol shall bear the
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statement ‘‘Excess consumption may ance with the following conditions, if have a laxative effect’’. the substitution for nutritive sweet- (f) In accordance with § 180.1, ade- eners is for a valid special dietary pur- quate and appropriate feeding studies pose and is in accord with current spe- have been undertaken for this sub- cial dietary food regulations and poli- stance. Continued uses of this ingre- cies or if the use or intended use is for dient are contingent upon timely and an authorized technological purpose adequate progress reports of such tests, other than calorie reduction: and no indication of increased risk to (a) Saccharin is the chemical, 1,2- public health during the test period. benzisothiazolin-3-one - 1,1 - dioxide (g) Prior sanctions for this ingredient (C7H5NO3S). The named salts of sac- different from the uses established in charin are produced by the additional this regulation do not exist or have neutralization of saccharin with the been waived. proper base to yield the desired salt. [42 FR 14636, Mar. 15, 1977, as amended at 49 (b) The food additives meet the speci- FR 5610, Feb. 14, 1984; 61 FR 7991, Mar. 1, 1996] fications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), pp. 22, 62, 266–267, § 180.30 Brominated vegetable oil. 297–299, which is incorporated by ref- The food additive brominated vege- erence. Copies may be obtained from table oil may be safely used in accord- the National Academy Press, 2101 Con- ance with the following prescribed con- stitution Ave. NW., Washington, DC ditions: 20418, or may be examined at the Office (a) The additive complies with speci- of the Federal Register, 800 North Cap- fications prescribed in the ‘‘Food itol Street, NW., suite 700, Washington, Chemicals Codex,’’ 3d Ed. (1981), pp. 40– DC 20408. 41, which is incorporated by reference, (c) Authority for such use shall ex- except that free fatty acids (as oleic) pire when the Commissioner receives shall not exceed 2.5 percent and iodine the final reports on the ongoing studies value shall not exceed 16. Copies of the in Canada and publishes an order on material incorporated by reference the safety of saccharin and its salts may be obtained from the National based on those reports and other avail- Academy Press, 2101 Constitution Ave. able data. NW., Washington, DC 20418, or may be (d) The additives are used or intended examined at the Office of the Federal for use as a sweetening agent only in Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20418. special dietary foods, as follows: (b) The additive is used on an interim (1) In beverages, fruit juice drinks, basis as a stabilizer for flavoring oils and bases or mixes when prepared for used in fruit-flavored beverages, for consumption in accordance with direc- which any applicable standards of iden- tions, in amounts not to exceed 12 mil- tity do not preclude such use, in an ligrams of the additive, calculated as amount not to exceed 15 parts per mil- saccharin, per fluid ounce. lion in the finished beverage, pending (2) As a sugar substitute for cooking the outcome of additional toxicological or table use, in amounts not to exceed studies on which periodic reports at 6- 20 milligrams of the additive, cal- month intervals are to be furnished culated as saccharin, for each ex- and final results submitted to the Food pressed teaspoonful of sugar sweet- and Drug Administration promptly ening equivalency. after completion of the studies. (3) In processed foods, in amounts not to exceed 30 milligrams of the additive, [42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984] calculated as saccharin, per serving of designated size. § 180.37 Saccharin, ammonium sac- (e) The additives are used or intended charin, calcium saccharin, and so- for use only for the following techno- dium saccharin. logical purposes: The food additives saccharin, ammo- (1) To reduce bulk and enhance fla- nium saccharin, calcium saccharin, and vors in chewable vitamin tablets, sodium saccharin may be safely used as chewable mineral tablets, or combina- sweetening agents in food in accord- tions thereof.
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(2) To retain flavor and physical 181.27 Plasticizers. properties of chewing gum. 181.28 Release agents. (3) To enhance flavor of flavor chips 181.29 Stabilizers. used in nonstandardized bakery prod- 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. SOURCE: 42 FR 14638, Mar. 15, 1977, unless (ii) A statement of the concentration 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- plies with the limitations prescribed in Subpart A—General Provisions paragraphs (d) and (e) of this section. (2) The label of any finished food § 181.1 General. product containing the additive shall (a) An ingredient whose use in food bear: or food packaging is subject to a prior (i) The name of the additive. sanction or approval within the mean- (ii) The amount of the additive, cal- ing of section 201(s)(4) of the Act is ex- culated as saccharin, as follows: empt from classification as a food addi- (a) For beverages, in milligrams per tive. The Commissioner will publish in fluid ounce; this part all known prior sanctions. (b) For cooking or table use products, 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 shall be that quantity of the food con- evidence to show that it falls within taining 30 milligrams or less of the ad- section 201(s)(4) of the Act. ditive. (b) Based upon scientific data or in- (iii) When the additive is used for cal- formation that shows that use of a orie reduction, such other labeling as is prior-sanctioned food ingredient may required by part 105 or § 100.130 of this be injurious to health, and thus in vio- chapter. lation of section 402 of the Act, the Commissioner will establish or amend [42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984] an applicable prior sanction regulation to impose whatever limitations or con- ditions are necessary for the safe use of PART 181—PRIOR-SANCTIONED the ingredient, or to prohibit use of the FOOD INGREDIENTS ingredient. (c) Where appropriate, an emergency Subpart A—General Provisions action level may be issued for a prior- Sec. sanctioned substance, pending the 181.1 General. issuance of a final regulation in ac- 181.5 Prior sanctions. cordance with paragraph (b) of this sec- tion. Such an action level shall be Subpart B—Specific Prior-Sanctioned Food issued pursuant to section 402(a) of the Ingredients Act to identify, based upon available 181.22 Certain substances employed in the data, conditions of use of the substance manufacture of food-packaging mate- that may be injurious to health. Such rials. an action level shall be issued in a no- 181.23 Antimycotics. tice published in the FEDERAL REG- 181.24 Antioxidants. 181.25 Driers. ISTER and shall be followed as soon as 181.26 Drying oils as components of finished practicable by a proposed regulation in resins. accordance with paragraph (b) of this
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section. Where the available data dem- such sanction to submit proof of its ex- onstrate that the substance may be in- istence. Any food additive or GRAS jurious at any level, use of the sub- regulation promulgated after a general stance may be prohibited. The identi- evaluation of use of an ingredient con- fication of a prohibited substance may stitutes a determination that excluded be made in part 189 of this chapter uses would result in adulteration of the when appropriate. food in violation of section 402 of the [42 FR 14638, Mar. 15, 1977, as amended at 42 Act, and the failure of any person to FR 52821, Sept. 30, 1977; 54 FR 39635, Sept. 27, come forward with proof of such an ap- 1989] plicable prior sanction in response to a proposal will constitute a waiver of the § 181.5 Prior sanctions. right to assert or rely on such sanction (a) A prior sanction shall exist only at any later time. The notice will also for a specific use(s) of a substance in constitute a proposal to establish a food, i.e., the level(s), condition(s), regulation under this part, incor- product(s), etc., for which there was ex- porating the same provisions, in the plicit approval by the Food and Drug Administration or the United States event that such a regulation is deter- Department of Agriculture prior to mined to be appropriate as a result of September 6, 1958. submission of proof of such an applica- (b) The existence of a prior sanction ble prior sanction in response to the exempts the sanctioned use(s) from the proposal. food additive provisions of the Act but not from the other adulteration or the Subpart B—Specific Prior- misbranding provisions of the Act. Sanctioned Food Ingredients (c) All known prior sanctions shall be the subject of a regulation published in § 181.22 Certain substances employed this part. Any such regulation is sub- in the manufacture of food-pack- ject to amendment to impose whatever aging materials. limitation(s) or condition(s) may be Prior to the enactment of the food necessary for the safe use of the ingre- additives amendment to the Federal dient, or revocation to prohibit use of Food, Drug, and Cosmetic Act, sanc- the ingredient, in order to prevent the adulteration of food in violation of sec- tions were granted for the usage of the tion 402 of the Act. substances listed in §§ 181.23, 181.24, (d) In proposing, after a general eval- 181.25, 181.26, 181.27, 181.28, 181.29, and uation of use of an ingredient, regula- 181.30 in the manufacture of packaging tions affirming the GRAS status of materials. So used, these substances substances added directly to human are not considered ‘‘food additives’’ food in part 184 of this chapter or sub- within the meaning of section 201(s) of stances in food-contact surfaces in part the Act, provided that they are of good 186 of this chapter, or establishing a commercial grade, are suitable for as- food additive regulation for substances sociation with food, and are used in ac- added directly to human food in parts cordance with good manufacturing 172 and 173 of this chapter or food addi- practice. For the purpose of this sub- tives in food-contact surfaces in parts part, good manufacturing practice for 174, 175, 176, 177, 178 and § 179.45 of this food-packaging materials includes the chapter, the Commissioner shall, if he restriction that the quantity of any of is aware of any prior sanction for use these substances which becomes a com- of the ingredient under conditions dif- ponent of food as a result of use in ferent from those proposed in the regu- food-packaging materials shall not be lation, concurrently propose a separate intended to accomplish any physical or regulation covering such use of the in- technical effect in the food itself, shall gredient under this part. If the Com- be reduced to the least amount reason- missioner is unaware of any such appli- ably possible, and shall not exceed any cable prior sanction, the proposed regu- limit specified in this subpart. lation will so state and will require any person who intends to assert or rely on [42 FR 56728, Oct. 28, 1977]
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§ 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: § 181.27 Plasticizers. Calcium propionate. Substances classified as plasticizers, Methylparaben (methyl p-hydroxybenzoate). when migrating from food-packaging Propylparaben (propyl p-hydroxybenzoate). material shall include: Sodium benzoate. Sodium propionate. Acetyl tributyl citrate. Sorbic acid. Acetyl triethyl citrate. p-tert-Butylphenyl salicylate. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. Butyl stearate. 28, 1977] Butylphthalyl butyl glycolate. Dibutyl sebacate. § 181.24 Antioxidants. Di-(2-ethylhexyl) phthalate (for foods of high Substances classified as antioxidants, water content only). when migrating from food-packaging Diethyl phthalate. material (limit of addition to food, Diisobutyl adipate. 0.005 percent) shall include: Diisooctyl phthalate (for foods of high water content only). Butylated hydroxyanisole. Diphenyl-2-ethylhexyl phosphate. Butylated hydroxytoluene. Epoxidized soybean oil (iodine number max- Dilauryl thiodipropionate. imum 6; and oxirane oxygen, minimum, 6.0 Distearyl thiodipropionate. percent). Gum guaiac. Ethylphthalyl ethyl glycolate. Nordihydroguairetic acid. Glycerol monooleate. Propyl gallate. Monoisopropyl citrate. Thiodipropionic acid. Mono, di-, and tristearyl citrate. Triacetin (glycerol triacetate). 2,4,5-Trihydroxy butyrophenone. Triethyl citrate. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 3-(2-Xenolyl)-1,2-epoxypropane. 28, 1977] [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 50 FR 49536, Dec. 3, § 181.25 Driers. 1985] Substances classified as driers, when migrating from food-packaging mate- § 181.28 Release agents. rial shall include: Substances classified as release Cobalt caprylate. agents, when migrating from food- Cobalt linoleate. packaging material shall include: Cobalt naphthenate. Dimethylpolysiloxane (substantially free Cobalt tallate. from hydrolyzable chloride and alkoxy Iron caprylate. groups, no more than 18 percent loss in Iron linoleate. weight after heating 4 hours at 200 °C.; vis- Iron naphthenate. cosity 300 centisokes, 600 centisokes at 25 Iron tallate. °C, specific gravity 0.96 to 0.97 at 25 °C, re- Manganese caprylate. fractive index 1.400 to 1.404 at 25 °C). Manganese linoleate. Linoleamide (linoleic acid amide). Manganese naphthenate. Oleamide (oleic acid amide). Manganese tallate. Palmitamide (palmitic acid amide). [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. Stearamide (stearic acid amide). 28, 1977] [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977] § 181.26 Drying oils as components of finished resins. § 181.29 Stabilizers. Substances classified as drying oils, Substances classified as stabilizers, when migrating from food-packaging when migrating from food-packaging material (as components of finished material shall include: resins) shall include: Aluminum mono-, di-, and tristearate. Chinawood oil (tung oil). Ammonium citrate. Dehydrated castor oil. Ammonium potassium hydrogen phosphate. Linseed oil. Calcium glycerophosphate.
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Calcium phosphate. Methyl ethers of mono-, di-, and tripropylene Calcium hydrogen phosphate. glycol.* Calcium oleate. Myristo chromic chloride complex. Calcium acetate. Nitrocellulose. Calcium carbonate. Polyethylene glycol 400. Calcium ricinoleate. Polyvinyl acetate. Calcium stearate. Potassium pentachlorophenate as a slime Disodium hydrogen phosphate. Magnesium glycerophosphate. control agent.* Magnesium stearate. Potassium trichlorophenate as a slime con- Magnesium phosphate. trol agent.* Magnesium hydrogen phosphate. Resins from high and low viscosity polyvinyl Mono-, di-, and trisodium citrate. alcohol for fatty foods only. Mono-, di-, and tripotassium citrate. Rubber hydrochloride. Potassium oleate. Sodium pentachlorophenate as a slime con- Potassium stearate. trol agent.* Sodium pyrophosphate. Sodium-trichlorophenate as a slime control Sodium stearate. agent.* Sodium tetrapyrophosphate. Stearato-chromic chloride complex. Stannous stearate (not to exceed 50 parts per Titanium dioxide.* million tin as a migrant in finished food). Zinc orthophosphate (not to exceed 50 parts Urea formaldehyde polymer. per million zinc as a migrant in finished Vinylidine chlorides (polymerized). food). Zinc resinate (not to exceed 50 parts per mil- § 181.32 Acrylonitrile copolymers and lion zinc as a migrant in finished food). resins. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. (a) Acrylonitrile copolymers and res- 28, 1977] ins listed in this section, containing less than 30 percent acrylonitrile and § 181.30 Substances used in the manu- complying with the requirements of facture of paper and paperboard products used in food packaging. paragraph (b) of this section, may be safely used as follows: Substances used in the manufacture (1) Films. (i) Acrylonitrile/butadiene/ of paper and paperboard products used styrene copolymers—no restrictions. in food packaging shall include: (ii) Acrylonitrile/butadiene copoly- Aliphatic polyoxyethylene ethers.* mers—no restrictions. 1-Alkyl (C6-C18)3-amino-3-aminopropane (iii) Acrylonitrile/butadiene copoly- monoacetate.* Borax or boric acid for use in adhesives, mer blended with vinyl chloride-vinyl sizes, and coatings.* acetate (optional at level up to 5 per- Butadiene-styrene copolymer. cent by weight of the vinyl chloride Chromium complex of perfluoro-octane resin) resin—for use only in contact sulfonyl glycine for use on paper and pa- with oleomargarine. perboard which is waxed.* (iv) Acrylonitrile/styrene copoly- Disodium cyanodithioimidocarbamate with ethylene diamine and potassium N-methyl mer—no restrictions. dithiocarbamate and/or sodium 2- (2) Coatings. (i) Acrylonitrile/buta- mercaptobenzothiazole (slimicides).* diene copolymer blended with poly- Ethyl acrylate and methyl methacrylate co- vinyl chloride resins—for use only on polymers of itaconic acid or methacrylic paper and paperboard in contact with acid for use only on paper and paperboard meats and lard. which is waxed.* Hexamethylene tetramine as a setting agent (ii) Polyvinyl chloride resin blended for protein, including casein.* with either acrylonitrile/butadiene co- 1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2-alkyl polymer or acrylonitrile/butadiene sty- (C6-C17) imidazolinium chloride.* rene copolymer mixed with neoprene, Itaconic acid (polymerized). for use as components of conveyor Melamine formaldehyde polymer. Methyl acrylate (polymerized). belts to be used with fresh fruits, vege- tables, and fish. (iii) Acrylonitrile/butadiene/styrene *Under the conditions of normal use, these substances would not reasonably be expected copolymer—no restrictions. to migrate to food, based on available sci- (iv) Acrylonitrile/styrene copoly- entific information and data. mer—no restrictions.
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(3) Rigid and semirigid containers. (i) article containing acrylonitrile copoly- Acrylonitrile/butadiene/styrene copoly- mers or resins that yield acrylonitrile mer—for use only as piping for han- monomer in excess of that amount pro- dling food products and for repeated- vided for in paragraph (b) of this sec- use articles intended to contact food. tion shall be deemed to be adulterated (ii) Acrylonitrile/styrene resin—no in violation of section 402 of the Act. restrictions. (iii) Acrylonitrile/butadiene copoly- [42 FR 14638, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, mer blended with polyvinyl chloride 1989] resin—for use only as extruded pipe. (b) Limitations for acrylonitrile § 181.33 Sodium nitrate and potassium monomer extraction for finished food- nitrate. contact articles, determined by using Sodium nitrate and potassium ni- the method of analysis titled ‘‘Gas- trate are subject to prior sanctions Solid Chromatographic Procedure for issued by the U.S. Department of Agri- Determining Acrylonitrile Monomer in culture for use as sources of nitrite, Acrylonitrile-Containing Polymers and with or without sodium or potassium Food-Simulating Solvents,’’ which is nitrite, in the production of cured red incorporated by reference. Copies are meat products and cured poultry prod- available from the Center for Food ucts. Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, [48 FR 1705, Jan. 14, 1983] 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of § 181.34 Sodium nitrite and potassium the Federal Register, 800 North Capitol nitrite. Street, NW., suite 700, Washington, DC Sodium nitrite and potassium nitrite 20408, are as follows: are subject to prior sanctions issued by (1) In the case of single-use articles the U.S. Department of Agriculture for having a volume to surface ratio of 10 use as color fixatives and preservative milliliters or more per square inch of agents, with or without sodium or po- food-contact surface—0.003 milligram/ tassium nitrate, in the curing of red square inch when extracted to equi- meat and poultry products. ° librium at 120 F with food-simulating [48 FR 1705, Jan. 14, 1983] solvents appropriate to the intended conditions of use. (2) In the case of single-use articles PART 182—SUBSTANCES having a volume to surface ratio of less GENERALLY RECOGNIZED AS SAFE than 10 milliliters per square inch of food-contact surface—0.3 part per mil- Subpart A—General Provisions lion calculated on the basis of the vol- Sec. ume of the container when extracted to 182.1 Substances that are generally recog- equilibrium at 120 °F with food-simu- nized as safe. lating solvents appropriate to the in- 182.10 Spices and other natural seasonings tended conditions of use. and flavorings. (3) In the case of repeated-use arti- 182.20 Essential oils, oleoresins (solvent- cles—0.003 milligram/square inch when free), and natural extractives (including extracted at a time equivalent to ini- distillates). tial batch usage utilizing food-simu- 182.40 Natural extractives (solvent-free) used in conjunction with spices, lating solvents and temperatures ap- seasonings, and flavorings. propriate to the intended conditions of 182.50 Certain other spices, seasonings, es- use. sential oils, oleoresins, and natural ex- The food-simulating solvents shall in- tracts. clude, where applicable, distilled 182.60 Synthetic flavoring substances and water, 8 percent or 50 percent ethanol, adjuvants. 182.70 Substances migrating from cotton 3 percent acetic acid, and either n- and cotton fabrics used in dry food pack- heptane or an appropriate oil or fat. aging. (c) Acrylonitrile monomer may 182.90 Substances migrating to food from present a hazard to health when in- paper and paperboard products. gested. Accordingly, any food-contact 182.99 Adjuvants for pesticide chemicals.
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Subpart B—Multiple Purpose GRAS Food 182.6197 Calcium diacetate. Substances 182.6203 Calcium hexametaphosphate. 182.6215 Monobasic calcium phosphate. 182.1045 Glutamic acid. 182.6285 Dipotassium phosphate. 182.1047 Glutamic acid hydrochloride. 182.6290 Disodium phosphate. 182.1057 Hydrochloric acid. 182.6757 Sodium gluconate. 182.1073 Phosphoric acid. 182.6760 Sodium hexametaphosphate. 182.1087 Sodium acid pyrophosphate. 182.6769 Sodium metaphosphate. 182.1125 Aluminum sulfate. 182.6778 Sodium phosphate. 182.1127 Aluminum ammonium sulfate. 182.6787 Sodium pyrophosphate. 182.1129 Aluminum potassium sulfate. 182.6789 Tetra sodium pyrophosphate. 182.1131 Aluminum sodium sulfate. 182.6810 Sodium tripolyphosphate. 182.1180 Caffeine. 182.1217 Calcium phosphate. Subpart H—Stabilizers 182.1235 Caramel. 182.7255 Chondrus extract. 182.1320 Glycerin. 182.1480 Methylcellulose. Subpart I—Nutrients 182.1500 Monoammonium glutamate. 182.1516 Monopotassium glutamate. 182.8013 Ascorbic acid. 182.1711 Silica aerogel. 182.8159 Biotin. 182.1745 Sodium carboxymethylcellulose. 182.8217 Calcium phosphate. 182.1748 Sodium caseinate. 182.8223 Calcium pyrophosphate. 182.1778 Sodium phosphate. 182.8250 Choline bitartrate. 182.1781 Sodium aluminum phosphate. 182.8252 Choline chloride. 182.1810 Sodium tripolyphosphate. 182.8778 Sodium phosphate. 182.8890 Tocopherols. Subpart C—Anticaking Agents 182.8892 a-Tocopherol acetate. 182.8985 Zinc chloride. 182.2122 Aluminum calcium silicate. 182.8988 Zinc gluconate. 182.2227 Calcium silicate. 182.8991 Zinc oxide. 182.2437 Magnesium silicate. 182.8994 Zinc stearate. 182.2727 Sodium aluminosilicate. 182.8997 Zinc sulfate. 182.2729 Sodium calcium aluminosilicate, hydrated. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. 182.2906 Tricalcium silicate. SOURCE: 42 FR 14640, Mar. 15, 1977, unless otherwise noted. Subpart D—Chemical Preservatives 182.3013 Ascorbic acid. Subpart A—General Provisions 182.3041 Erythorbic acid. 182.3089 Sorbic acid. § 182.1 Substances that are generally 182.3109 Thiodipropionic acid. recognized as safe. 182.3149 Ascorbyl palmitate. (a) It is impracticable to list all sub- 182.3169 Butylated hydroxyanisole. stances that are generally recognized 182.3173 Butylated hydroxytoluene. as safe for their intended use. However, 182.3189 Calcium ascorbate. 182.3225 Calcium sorbate. by way of illustration, the Commis- 182.3280 Dilauryl thiodipropionate. sioner regards such common food in- 182.3616 Potassium bisulfite. gredients as salt, pepper, vinegar, bak- 182.3637 Potassium metabisulfite. ing powder, and monosodium glu- 182.3640 Potassium sorbate. tamate as safe for their intended use. 182.3731 Sodium ascorbate. This part includes additional sub- 182.3739 Sodium bisulfite. stances that, when used for the pur- 182.3766 Sodium metabisulfite. poses indicated, in accordance with 182.3795 Sodium sorbate. 182.3798 Sodium sulfite. good manufacturing practice, are re- 182.3862 Sulfur dioxide. garded by the Commissioner as 182.3890 Tocopherols. generaly recognized as safe for such uses. SubpartE—Emulsifying Agents [Reserved] (b) For the purposes of this section, good manufacturing practice shall be SubpartF—Dietary Supplements defined to include the following re- [Reserved] strictions: (1) The quantity of a substance added Subpart G—Sequestrants to food does not exceed the amount 182.6085 Sodium acid phosphate. reasonably required to accomplish its
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intended physical, nutritional, or other (d) Substances that are generally rec- technical effect in food; and ognized as safe for their intended use (2) The quantity of a substance that within the meaning of section 409 of becomes a component of food as a re- the act are listed in this part. When sult of its use in the manufacturing, the status of a substance has been re- processing, or packaging of food, and evaluated, it will be deleted from this which is not intended to accomplish part, and will be issued as a new regu- any physical or other technical effect lation under the appropriate part, e.g., in the food itself, shall be reduced to ‘‘affirmed as GRAS’’ under part 184 or the extent reasonably possible. 186 of this chapter; ‘‘food additive regu- (3) The substance is of appropriate lation’’ under parts 170 through 180 of food grade and is prepared and handled this chapter; ‘‘interim food additive as a food ingredient. Upon request the regulation’’ under part 180 of this chap- Commissioner will offer an opinion, ter; or ‘‘prohibited from use in food’’ based on specifications and intended under part 189 of this chapter. use, as to whether or not a particular grade or lot of the substance is of suit- [42 FR 14640, Mar. 15, 1977, as amended at 53 able purity for use in food and would FR 44875, Nov. 7, 1988] generally be regarded as safe for the purpose intended, by experts qualified § 182.10 Spices and other natural to evaluate its safety. seasonings and flavorings. (c) The inclusion of substances in the Spices and other natural seasonings list of nutrients does not constitute a and flavorings that are generally rec- finding on the part of the Department ognized as safe for their intended use, that the substance is useful as a sup- within the meaning of section 409 of plement to the diet for humans. 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. 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.
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Common name Botanical name of plant source
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]
§ 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.
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Common name Botanical name of plant source
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. 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.
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Common name Botanical name of plant source
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. 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.
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Common name Botanical name of plant source
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 3-Methyl-3-phenyl glycidic acid ethyl ester and adjuvants. (ethyl-methyl-phenyl-glycidate, so-called strawberry aldehyde, C-16 aldehyde). Synthetic flavoring substances and Ethyl vanillin. adjuvants that are generally recog- Geraniol (3,7-dimethyl-2,6 and 3,6-octadien-1- nized as safe for their intended use, ol). within the meaning of section 409 of Geranyl acetate (geraniol acetate). the Act, are as follows: Limonene (d-, l-, and dl-). Linalool (linalol, 3,7-dimethyl-1,6-octadien-3- Acetaldehyde (ethanal). ol). Acetoin (acetyl methylcarbinol). Linalyl acetate (bergamol). Anethole (parapropenyl anisole). Methyl anthranilate (methyl-2- Benzaldehyde (benzoic aldehyde). aminobenzoate). N-Butyric acid (butanoic acid). Piperonal (3,4-methylenedioxy-benzaldehyde, d- or l-Carvone (carvol). heliotropin). Cinnamaldehyde (cinnamic aldehyde). Vanillin. Citral (2,6-dimethyloctadien-2,6-al-8, gera- nial, neral). [42 FR 14640, Mar. 15, 1977, as amended at 43 Decanal (N-decylaldehyde, capraldehyde, FR 47724, Oct. 17, 1978; 44 FR 3963, Jan. 19, capric aldehyde, caprinaldehyde, aldehyde 1979; 44 FR 20656, Apr. 6, 1979; 48 FR 51907, C-10). Nov. 15, 1983; 54 FR 7402, Feb. 21, 1989] Ethyl acetate. Ethyl butyrate.
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§ 182.70 Substances migrating from Silicon dioxides. cotton and cotton fabrics used in Sodium aluminate. dry food packaging. Sodium chloride. Sodium hexametaphosphate. Substances migrating to food from Sodium hydrosulfite. cotton and cotton fabrics used in dry Sodium phosphoaluminate. food packaging that are generally rec- Sodium silicate. ognized as safe for their intended use, Sodium sorbate. within the meaning of section 409 of Sodium tripolyphosphate. Sorbitol. the Act, are as follows: Soy protein, isolated. Beef tallow. Starch, acid modified. Carboxymethylcellulose. Starch, pregelatinized. Coconut oil, refined. Starch, unmodified. Cornstarch. Talc. Gelatin. Vanillin. Lard. Zinc hydrosulfite. Lard oil. Zinc sulfate. Oleic acid. [42 FR 14640, Mar. 15, 1977] Peanut oil. Potato starch. EDITORIAL NOTE: For additional FEDERAL Sodium acetate. REGISTER citations affecting § 182.90, see the Sodium chloride. List of CFR Sections Affected, which appears Sodium silicate. in the Finding Aids section of the printed Sodium tripolyphosphate. volume and on GPO Access. Soybean oil (hydrogenated). Talc. § 182.99 Adjuvants for pesticide chemi- Tallow (hydrogenated). cals. Tallow flakes. Adjuvants, identified and used in ac- Tapioca starch. Tetrasodium pyrophosphate. cordance with 40 CFR 180.1001 (c) and Wheat starch. (d), which are added to pesticide use di- Zinc chloride. lutions by a grower or applicator prior to application to the raw agricultural [42 FR 14640, Mar. 15, 1977, as amended at 43 FR 11698, Mar. 21, 1978; 44 FR 28323, May 15, commodity, are exempt from the re- 1979; 45 FR 6085, Jan. 25, 1980; 47 FR 27807, quirement of tolerances under section 27814, June 25, 1982; 48 FR 51150, Nov. 7, 1983; 409 of the Act. 48 FR 51616, Nov. 10, 1983; 48 FR 51909, Nov. 15, 1983; 48 FR 52441, 52443, 52445, 52446, Nov. 18, Subpart B—Multiple Purpose GRAS 1983; 51 FR 16830, May 7, 1986; 51 FR 27171, July 30, 1986; 60 FR 62208, Dec. 5, 1995] Food Substances
§ 182.90 Substances migrating to food § 182.1045 Glutamic acid. from paper and paperboard prod- (a) Product. Glutamic acid. ucts. (b) [Reserved] Substances migrating to food from (c) Limitations, restrictions, or expla- paper and paperboard products used in nation. This substance is generally rec- food packaging that are generally rec- ognized as safe when used as a salt sub- ognized as safe for their intended use, stitute in accordance with good manu- within the meaning of section 409 of facturing practice. the Act, are as follows: § 182.1047 Glutamic acid hydro- Alum (double sulfate of aluminum and am- chloride. monium potassium, or sodium). Aluminum hydroxide. (a) Product. Glutamic acid hydro- Aluminum oleate. chloride. Aluminum palmitate. (b) [Reserved] Casein. (c) Limitations, restrictions, or expla- Cellulose acetate. nation. This substance is generally rec- Cornstarch. ognized as safe when used as a salt sub- Diatomaceous earth filler. stitute in accordance with good manu- Ethyl cellulose. facturing practice. Ethyl vanillin. Glycerin. Oleic acid. § 182.1057 Hydrochloric acid. Potassium sorbate. (a) Product. Hydrochloric acid.
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(b) [Reserved] (c) Limitations, restrictions, or expla- (c) Limitations, restrictions, or expla- nation. This substance is generally rec- nation. This substance is generally rec- ognized as safe when used in cola-type ognized as safe when used as a buffer beverages in accordance with good and neutralizing agent in accordance manufacturing practice. with good manufacturing practice. § 182.1217 Calcium phosphate. § 182.1073 Phosphoric acid. (a) Product. Calcium phosphate (a) Product. Phosphoric acid. (mono-, di-, and tribasic). (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 manufac- turing practice. turing practice.
§ 182.1087 Sodium acid pyrophosphate. § 182.1235 Caramel. (a) Product. Sodium acid (a) Product. Caramel. pyrophosphate. (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 manufac- turing practice. turing practice. § 182.1320 Glycerin. § 182.1125 Aluminum sulfate. (a) Product. Glycerin. (a) Product. Aluminum sulfate. (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 manufac- turing practice. turing practice. § 182.1480 Methylcellulose. § 182.1127 Aluminum ammonium sul- (a) Product. U.S.P. methylcellulose, fate. except that the methoxy content shall (a) Product. Aluminum ammonium not be less than 27.5 percent and not sulfate. more than 31.5 percent on a dry-weight (b) Conditions of use. This substance basis. 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- turing practice. § 182.1129 Aluminum potassium sul- fate. § 182.1500 Monoammonium glutamate. (a) Product. Aluminum potassium sul- (a) Product. Monoammonium glu- fate. tamate. (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 manufac- turing practice. turing practice.
§ 182.1131 Aluminum sodium sulfate. § 182.1516 Monopotassium glutamate. (a) Product. Aluminum sodium sul- (a) Product. Monopotassium glu- fate. tamate. (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 manufac- turing practice. turing practice.
§ 182.1180 Caffeine. § 182.1711 Silica aerogel. (a) Product. Caffeine. (a) Product. Silica aerogel as a finely (b) Tolerance. 0.02 percent. powdered microcellular silica foam
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having a minimum silica content of Subpart C—Anticaking Agents 89.5 percent. (b) [Reserved] § 182.2122 Aluminum calcium silicate. (c) Limitations, restrictions, or expla- (a) Product. Aluminum calcium sili- nation. This substance is generally rec- cate. ognized as safe when used as a compo- (b) Tolerance. 2 percent. nent of an anti-foaming agent in ac- (c) Limitations, restrictions, or expla- cordance with good manufacturing nation. This substance is generally rec- practice. ognized as safe when used in table salt in accordance with good manufacturing § 182.1745 Sodium carboxymethylcellu- practice. lose. (a) Product. Sodium carboxy- § 182.2227 Calcium silicate. methylcellulose is the sodium salt of (a) Product. Calcium silicate. carboxymethylcellulose not less than (b) Tolerance. 2 percent and 5 percent. 99.5 percent on a dry-weight basis, with (c) Limitations, restrictions, or expla- maximum substitution of 0.95 nation. This substance is generally rec- carboxymethyl groups per ognized as safe when used at levels not anhydroglucose unit, and with a min- exceeding 2 percent in table salt and 5 imum viscosity of 25 centipoises for 2 percent in baking powder in accordance percent by weight aqueous solution at with good manufacturing practice. 25 °C. (b) Conditions of use. This substance § 182.2437 Magnesium silicate. is generally recognized as safe when (a) Product. Magnesium silicate. used in accordance with good manufac- (b) Tolerance. 2 percent. turing practice. (c) Limitations, restrictions, or expla- nation. This substance is generally rec- § 182.1748 Sodium caseinate. ognized as safe when used in table salt (a) Product. Sodium caseinate. in accordance with good manufacturing (b) Conditions of use. This substance practice. is generally recognized as safe when § 182.2727 Sodium aluminosilicate. used in accordance with good manufac- turing practice. (a) Product. Sodium aluminosilicate (sodium silicoaluminate). § 182.1778 Sodium phosphate. (b) Tolerance. This substance is gen- erally recognized as safe for use at a (a) Product. Sodium phosphate level not exceeding 2 percent in accord- (mono-, di-, and tribasic). ance with good manufacturing prac- (b) Conditions of use. This substance tice. is generally recognized as safe when used in accordance with good manufac- § 182.2729 Sodium calcium turing practice. aluminosilicate, hydrated. (a) Product. Hydrated sodium calcium § 182.1781 Sodium aluminum phos- phate. aluminosilicate (sodium calcium silicoaluminate). (a) Product. Sodium aluminum phos- (b) Tolerance. This substance is gen- phate. erally recognized as safe for use at a (b) Conditions of use. This substance level not exceeding 2 percent in accord- is generally recognized as safe when ance with good manufacturing prac- used in accordance with good manufac- tice. turing practice. § 182.2906 Tricalcium silicate. § 182.1810 Sodium tripolyphosphate. (a) Product. Tricalcium silicate. (a) Product. Sodium (b) Tolerance. 2 percent. tripolyphosphate. (c) Limitations, restrictions, or expla- (b) Conditions of use. This substance nation. This substance is generally rec- is generally recognized as safe when ognized as safe when used in table salt used in accordance with good manufac- in accordance with good manufacturing turing practice. practice.
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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 manufac- turing practice. turing practice. § 182.3225 Calcium sorbate. § 182.3089 Sorbic acid. (a) Product. Calcium sorbate. (a) Product. Sorbic 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 manufac- turing practice. turing practice. § 182.3280 Dilauryl thiodipropionate. § 182.3109 Thiodipropionic acid. (a) Product. Dilauryl (a) Product. Thiodipropionic acid. thiodipropionate. (b) This substance is gen- Tolerance. (b) Tolerance. This substance is gen- erally recognized as safe for use in food erally recognized as safe for use in food when the total content of antioxidants when the total content of antioxidants is not over 0.02 percent of fat or oil content, including essential (volatile) is not over 0.02 percent of fat or oil oil content of the food, provided the content, including essential (volatile) substance is used in accordance with oil content of the food, provided the good manufacturing practice. substance is used in accordance with good manufacturing practice. § 182.3149 Ascorbyl palmitate. § 182.3616 Potassium bisulfite. (a) Product. Ascorbyl palmitate. (b) Conditions of use. This substance (a) Product. Potassium bisulfite. is generally recognized as safe when (b) [Reserved] used in accordance with good manufac- (c) Limitations, restrictions, or expla- turing practice. nation. This substance is generally rec- ognized as safe when used in accord- § 182.3169 Butylated hydroxyanisole. ance with good manufacturing prac- (a) Product. Butylated hydroxy- tice, except that it is not used in anisole. meats; in food recognized as a source of (b) Tolerance. This substance is gen- vitamin B1; on fruits and vegetables in- erally recognized as safe for use in food tended to be served raw to consumers when the total content of antioxidants or sold raw to consumers, or to be pre- is not over 0.02 percent of fat or oil sented to consumers as fresh. content, including essential (volatile) oil content of food, provided the sub- [42 FR 14640, Mar. 15, 1977, as amended at 51 stance is used in accordance with good FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, manufacturing practice. 1990; 59 FR 65939, Dec. 22, 1994]
§ 182.3173 Butylated hydroxytoluene. § 182.3637 Potassium metabisulfite. (a) Product. Butylated hydroxy- (a) Product. Potassium metabisulfite. toluene. (b) [Reserved]
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(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- (b) Conditions of use. This substance sented to consumers as fresh. 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] § 182.3798 Sodium sulfite. § 182.3640 Potassium sorbate. (a) Product. Sodium sulfite. (a) Product. Potassium sorbate. (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 in accord- turing practice. ance with good manufacturing prac- tice, except that it is not used in § 182.3731 Sodium ascorbate. meats; in food recognized as a source of (a) Product. Sodium ascorbate. vitamin B1; on fruits or vegetables in- (b) Conditions of use. This substance tended to be served raw to consumers is generally recognized as safe when or sold raw to consumers, or to be pre- used in accordance with good manufac- sented to consumers as fresh. turing practice. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, § 182.3739 Sodium bisulfite. 1990; 59 FR 65939, Dec. 22, 1994] (a) Product. Sodium bisulfite. (b) [Reserved] § 182.3862 Sulfur dioxide. (c) Limitations, restrictions, or expla- (a) Product. Sulfur dioxide. nation. This substance is generally rec- (b) [Reserved] ognized as safe when used in accord- (c) Limitations, restrictions, or expla- ance with good manufacturing prac- nation. This substance is generally rec- tice, except that it is not used in ognized as safe when used in accord- meats; in food recognized as a source of ance with good manufacturing prac- vitamin B1; on fruits or vegetables in- tice, except that it is not used in tended to be served raw to consumers meats; in food recognized as a source of or sold raw to consumers, or to be pre- vitamin B1; on fruits or vegetables in- sented to the consumer as fresh. tended to be served raw to consumers or sold raw to consumers, or to be pre- [42 FR 14640, Mar. 15, 1977, as amended at 51 sented to consumers as fresh. FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994] [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, § 182.3766 Sodium metabisulfite. 1990; 59 FR 65939, Dec. 22, 1994] (a) Product. Sodium metabisulfite. § 182.3890 Tocopherols. (b) [Reserved] (c) Limitations, restrictions, or expla- (a) Product. Tocopherols. nation. This substance is generally rec- (b) Conditions of use. This substance ognized as safe when used in accord- is generally recognized as safe when ance with good manufacturing prac- used in accordance with good manufac- tice, except that it is not used in turing practice. meats; in food recognized as a source of vitamin B1; on fruits or vegetables in- Subpart E—Emulsifying Agents tended to be served raw to consumers [Reserved] 458
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Subpart F—Dietary Supplements (b) Conditions of use. This substance [Reserved] is generally recognized as safe when used in accordance with good manufac- Subpart G—Sequestrants 1 turing practice. § 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 manufac- turing 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 manufac- § 182.6203 Calcium turing practice. hexametaphosphate. § 182.6778 Sodium phosphate. (a) Product. Calcium (a) Product. Sodium phosphate hexametaphosphate. (mono-, di-, and tribasic). (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 manufac- turing practice. turing practice. § 182.6215 Monobasic calcium phos- phate. § 182.6787 Sodium pyrophosphate. (a) Product. Monobasic calcium phos- (a) Product. Sodium pyrophosphate. phate. (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 manufac- turing practice. turing practice. § 182.6789 Tetra sodium § 182.6285 Dipotassium phosphate. pyrophosphate. (a) Product. Dipotassium phosphate. (a) Product. Tetra sodium (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 manufac- turing practice. § 182.6290 Disodium phosphate. § 182.6810 Sodium tripolyphosphate. (a) Product. Disodium phosphate. (b) Conditions of use. This substance (a) Product. Sodium is generally recognized as safe when tripolyphosphate. used in accordance with good manufac- (b) Conditions of use. This substance turing practice. is generally recognized as safe when used in accordance with good manufac- § 182.6757 Sodium gluconate. turing practice. (a) Product. Sodium gluconate. Subpart H—Stabilizers
1 For the purpose of this subpart, no at- § 182.7255 Chondrus extract. tempt has been made to designate those sequestrants that may also function as (a) Product. Chondrus extract chemical preservatives. (carrageenin).
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(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 manufac- turing practice. turing practice.
Subpart I—Nutrients § 182.8890 Tocopherols. (a) Product. Tocopherols. SOURCE: 45 FR 58838, Sept. 5, 1980, unless (b) Conditions of use. This substance otherwise noted. is generally recognized as safe when used in accordance with good manufac- § 182.8013 Ascorbic acid. turing practice. (a) Product. Ascorbic acid. (b) Conditions of use. This substance § 182.8892 α-Tocopherol acetate. is generally recognized as safe when (a) Product. α-Tocopherol acetate. used in accordance with good manufac- (b) Conditions of use. This substance turing practice. is generally recognized as safe when used in accordance with good manufac- § 182.8159 Biotin. turing practice. (a) Product. Biotin. (b) Conditions of use. This substance § 182.8985 Zinc chloride. is generally recognized as safe when (a) Product. Zinc chloride. used in accordance with good manufac- (b) Conditions of use. This substance turing practice. is generally recognized as safe when § 182.8217 Calcium phosphate. used in accordance with good manufac- turing practice. (a) Product. Calcium phosphate (mono-, di-, and tribasic). § 182.8988 Zinc gluconate. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Zinc gluconate. used in accordance with good manufac- (b) Conditions of use. This substance turing practice. is generally recognized as safe when used in accordance with good manufac- § 182.8223 Calcium pyrophosphate. turing practice. (a) Product. Calcium pyrophosphate. § 182.8991 Zinc oxide. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Zinc oxide. used in accordance with good manufac- (b) Conditions of use. This substance turing practice. is generally recognized as safe when used in accordance with good manufac- § 182.8250 Choline bitartrate. turing practice. (a) Product. Choline bitartrate. (b) Conditions of use. This substance § 182.8994 Zinc stearate. is generally recognized as safe when (a) Product. Zinc stearate prepared used in accordance with good manufac- from stearic acid free from chickedema turing practice. factor. (b) Conditions of use. This substance § 182.8252 Choline chloride. is generally recognized as safe when (a) Product. Choline chloride. used in accordance with good manufac- (b) Conditions of use. This substance turing practice. is generally recognized as safe when used in accordance with good manufac- § 182.8997 Zinc sulfate. turing practice. (a) Product. Zinc sulfate. (b) Conditions of use. This substance § 182.8778 Sodium phosphate. is generally recognized as safe when (a) Product. Sodium phosphate used in accordance with good manufac- (mono-, di-, and tribasic). turing practice.
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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 de- rived 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 α-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. 184.1077 Potassium acid tartrate. 184.1307 Ferric sulfate. 184.1081 Propionic acid. 184.1307a Ferrous ascorbate. 184.1090 Stearic acid. 184.1307b Ferrous carbonate. 184.1091 Succinic acid. 184.1307c Ferrous citrate. 184.1095 Sulfuric acid. 184.1307d Ferrous fumarate. 184.1097 Tannic acid. 184.1308 Ferrous gluconate. 184.1099 Tartaric acid. 184.1311 Ferrous lactate. 184.1101 Diacetyl tartaric acid esters of 184.1315 Ferrous sulfate. mono- and diglycerides. 184.1316 Ficin. 184.1115 Agar-agar. 184.1317 Garlic and its derivatives. 184.1120 Brown algae. 184.1318 Glucono delta-lactone. 184.1121 Red algae. 184.1321 Corn gluten. 184.1133 Ammonium alginate. 184.1322 Wheat gluten. 184.1135 Ammonium bicarbonate. 184.1323 Glyceryl monooleate. 184.1137 Ammonium carbonate. 184.1324 Glyceryl monostearate. 184.1138 Ammonium chloride. 184.1328 Glyceryl behenate. 184.1139 Ammonium hydroxide. 184.1329 Glyceryl palmitostearate. 184.1140 Ammonium citrate, dibasic. 184.1330 Acacia (gum arabic). 184.1141a Ammonium phosphate, monobasic. 184.1333 Gum ghatti. 184.1141b Ammonium phosphate, dibasic. 184.1339 Guar gum. 184.1143 Ammonium sulfate. 184.1343 Locust (carob) bean gum. 184.1148 Bacterially-derived carbohydrase 184.1349 Karaya gum (sterculia gum). enzyme preparation. 184.1351 Gum tragacanth. 184.1150 Bacterially-derived protease en- 184.1355 Helium. zyme preparation. 184.1366 Hydrogen peroxide. 184.1155 Bentonite. 184.1370 Inositol. 184.1157 Benzoyl peroxide. 184.1372 Insoluble glucose isomerase enzyme 184.1165 n–Butane and iso–butane. preparations. 184.1185 Calcium acetate. 184.1375 Iron, elemental. 184.1187 Calcium alginate. 184.1386 Isopropyl citrate. 184.1191 Calcium carbonate. 184.1387 Lactase enzyme preparation from 184.1193 Calcium chloride. Candida pseudotropicalis. 184.1195 Calcium citrate. 184.1388 Lactase enzyme preparation from 184.1199 Calcium gluconate. Kluyveromyces lactis. 184.1201 Calcium glycerophosphate. 184.1400 Lecithin.
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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 α-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. 184.1555 Rapeseed oil. 184.1945 Vitamin B12. 184.1560 Ox bile extract. 184.1950 Vitamin D. 184.1563 Ozone. 184.1973 Beeswax (yellow and white). 184.1583 Pancreatin. 184.1976 Candelilla wax. 184.1585 Papain. 184.1978 Carnauba wax. 184.1588 Pectins. 184.1979 Whey. 184.1595 Pepsin. 184.1979a Reduced lactose whey. 184.1610 Potassium alginate. 184.1979b Reduced minerals whey. 184.1613 Potassium bicarbonate. 184.1979c Whey protein concentrate. 184.1619 Potassium carbonate. 184.1983 Bakers yeast extract. 184.1622 Potassium chloride. 184.1984 Zein. 184.1625 Potassium citrate. 184.1985 Aminopeptidase enzyme prepara- 184.1631 Potassium hydroxide. tion derived from lactococcus lactis. 184.1634 Potassium iodide. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. 184.1635 Potassium iodate. 184.1639 Potassium lactate. SOURCE: 42 FR 14653, Mar 15, 1977, unless 184.1643 Potassium sulfate. otherwise noted. 184.1655 Propane. 184.1660 Propyl gallate. Subpart A—General Provisions 184.1666 Propylene glycol. 184.1670 Propylparaben. § 184.1 Substances added directly to 184.1676 Pyridoxine hydrochloride. human food affirmed as generally 184.1685 Rennet (animal-derived) and recognized as safe (GRAS). chymosin preparation (fermentation-de- rived). (a) The direct human food ingredi- 184.1695 Riboflavin. ents listed in this part have been re- 184.1697 Riboflavin-5′-phosphate (sodium). viewed by the Food and Drug Adminis- 184.1698 Rue. tration and determined to be generally 184.1699 Oil of rue. recognized as safe (GRAS) for the pur- 184.1702 Sheanut oil. poses and under the conditions pre- 184.1721 Sodium acetate. 184.1724 Sodium alginate. scribed. The regulations in this part 184.1733 Sodium benzoate. shall sufficiently describe each ingre- 184.1736 Sodium bicarbonate. dient to identify the characteristics of 184.1742 Sodium carbonate. the ingredient that has been affirmed
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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. and handled as a food ingredient; and (c) The listing of a food ingredient in that the quantity of the ingredient this part does not authorize the use of added to food does not exceed the such substance in a manner that may amount reasonably required to accom- lead to deception of the consumer or to plish the intended physical, nutri- any other violation of the Federal tional, or other technical effect in Food, Drug, and Cosmetic Act (the food. Act). (1) If the ingredient is affirmed as (d) The listing of more than one in- GRAS with no limitations on its condi- gredient to produce the same techno- tions of use other than current good logical effect does not authorize use of manufacturing practice, it shall be re- a combination of two or more ingredi- garded as GRAS if its conditions of use ents to accomplish the same techno- are consistent with the requirements of logical effect in any one food at a com- paragraph (b), (c), and (d) of this sec- bined level greater than the highest tion. When the Food and Drug Admin- level permitted for one of the ingredi- istration (FDA) determines that it is ents. 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 ingredient. For example, be affirmed as GRAS, he will concur- when the safety of an ingredient has rently propose a separate regulation been evaluated on the basis of limited covering such use of the ingredient conditions of use, the agency will de- under part 181 of this chapter. If the scribe in the regulation that affirms Commissioner is unaware of any such the GRAS status of the ingredient, one applicable prior sanction, the proposed or more of these limited conditions of regulation will so state and will re- use, which may include the category of quire any person who intends to assert food(s), the technical effect(s) or func- or rely on such sanction to submit tional use(s) of the ingredient, and the proof of its existence. Any regulation level(s) of use. If the ingredient is used promulgated pursuant to this section under conditions that are significantly constitutes a determination that ex- different from those described in the cluded uses would result in adultera- regulation, that use of the ingredient tion of the food in violation of section may not be GRAS. In such a case, a 402 of the Act, and the failure of any
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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 food processor independently to deter- and dairy product analogs as defined in mine that use of the ingredients will be § 170.3(n)(10) of this chapter; 0.5 percent in accordance with any limitations and for chewing gum as defined in good manufacturing practice gudelines § 170.3(n)(6) of this chapter; 9.0 percent prescribed. for condiments and relishes as defined (3) Adequate directions for use to in § 170.3(n)(8) of this chapter; 0.5 per- provide a final food product that com- cent for fats and oils as defined in plies with any limitations prescribed § 170.3(n)(12) of this chapter; 3.0 percent for the ingredient(s). for gravies and sauces as defined in [42 FR 14653, Mar. 15, 1977, as amended at 42 § 170.3(n)(24) of this chapter; 0.6 percent FR 55205, Oct. 14, 1977; 48 FR 48457, 48459, Oct. for meat products as defined in 19, 1983; 62 FR 15110, Mar. 31, 1997] § 170.3(n)(29) of this chapter; and 0.15 percent or less for all other food cat- Subpart B—Listing of Specific egories. The ingredient may also be Substances Affirmed as GRAS used in boiler water additives at levels not to exceed current good manufac- § 184.1005 Acetic acid. turing practice. (a) Acetic acid (C2H4O2, CAS Reg. No. (e) Prior sanctions for this ingredient 64–19–7) is known as ethanoic acid. It different from the uses established in occurs naturally in plant and animal this section do not exist or have been tissues. It is produced by fermentation waived. of carbohydrates or by organic syn- thesis. The principal synthetic meth- [47 FR 27814, June 25, 1982] ods currently employed are oxidation of acetaldehyde derived from ethylene, § 184.1007 Aconitic acid. liquid phase oxidation of butane, and (a) Aconitic acid (1,2,3- reaction of carbon monoxide with propenetricarboxylic acid (C6H6O6), methanol derived from natural gas. CAS Reg. No. 000499–12–7) occurs in the (b) The ingredient meets the speci- leaves and tubers of Aconitum napellus fications of the Food Chemicals Codex, L. and other Ranunculaceae. 3d Ed. (1981), p. 8, which is incorporated Transaconitic acid can be isolated dur- by reference. Copies are available from ing sugarcane processing, by precipita- the National Academy Press, 2101 Con- tion as the calcium salt from cane stitution Ave. NW., Washington, DC sugar or molasses. It may be syn- 20418, or available for inspection at the thesized by sulfuric acid dehydration of
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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 Academy Press, Box 285, 2101 Constitu- [43 FR 47724, Oct. 17, 1978, as amended at 49 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 § 184.1009 Adipic acid. the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Ad- (a) Adipic acid (C6H10O4, CAS Reg. No. ministration, 200 C St. SW., rm. 3321, 00124–04–9) is also known as 1,4- Washington, DC, or at the Office of the butanedicarboxylic acid or hexane- Federal Register, 800 North Capitol St. dioic acid. It is prepared by nitric acid NW., suite 700, Washington, DC. oxidation of cyclohexanol or (2) Melting point. Not less than 195 °C cyclohexanone or a mixture of the two. and the determination results in de- (b) The ingredient meets the speci- composition of aconitic acid. fications of the Food Chemicals Codex, (3) Heavy metals (as Pb). Not more 3d Ed. (1981), p. 11, which is incor- than 10 parts per million. porated by reference (copies are avail- (4) Arsenic (as As). Not more than 3 able from the National Academy Press, parts per million. 2101 Constitution Ave., NW., Wash- (5) Oxalate. Passes test. ington, DC 20418, or available for in- (6) Readily carbonizable substances. spection at the Office of the Federal Passes the test for citric acid of the Register, 800 North Capitol Street, ‘‘Food Chemicals Codex,’’ 4th ed. (1996), NW., suite 700, Washington, DC 20408), pp. 102–103, which is incorporated by and the following additional specifica- reference in accordance with 5 U.S.C. tions: 552(a) and 1 CFR part 51. The avail- (1) The adipic acid is converted to its ability of this incorporation by ref- corresponding amide. The amide is pu- erence is given in paragraph (b)(1) of rified by recrystallization from water this section. or aqueous ethanol. The melting range (7) Residue on ignition. Not more than of the amide is 219° to 220 °C. 0.1 percent as determined by the ‘‘Food (2) The adipic acid is converted to its Chemicals Codex,’’ 4th ed. (1996), pp. corresponding bis-p-p-bromophenacyl 102–103, test for citric acid, which is in- ester. The ester is purified by recrys- corporated by reference in accordance tallization from ethanol. The melting with 5 U.S.C. 552(a) and 1 CFR part 51. range of the ester is 153° to 154 °C. The availability of this incorporation (c) The ingredient is used as a fla- by reference is given in paragraph voring agent as defined in § 170.3(o)(12) (b)(1) of this section. of this chapter; leavening agent as de- (c) The ingredient is used as a fla- fined in § 170.3(o)(17) of this chapter; voring substance and adjuvant as de- and pH control agent as defined in fined in § 170.3(o)(12) of this chapter. § 170.3(o)(23) of this chapter. (d) The ingredient is used in food, in (d) The ingredient is used in foods at accordance with § 184.1(b)(1), at levels levels not to exceed current good man- not to exceed good manufacturing ufacturing practice in accordance with practice. Current good manufacturing § 184.1(b)(1). Current good manufac- practice results in a maximum level, as turing practice results in maximum served, of 0.003 percent for baked goods levels, as served, of 0.05 percent for as defined in § 170.3(n)(1) of this chap- baked goods as defined in § 170.3(n)(1) of
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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- cent for dairy product analogs as de- [47 FR 47375, Oct. 26, 1982] fined 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 in § 170.3(n)(20) of this chapter; 0.55 per- (a) α-Amylase enzyme preparation is cent for gelatin and puddings as de- obtained from the culture filtrate that fined in § 170.3(n)(22) of this chapter; 0.1 results from a pure culture fermenta- percent for gravies as defined in tion of a nonpathogenic and § 170.3(n)(24) of this chapter; 0.3 percent nontoxicogenic strain of Bacillus for meat products as defined in stearothermophilus. Its characterizing § 170.3(n)(29) of this chapter; 1.3 percent enzyme activity is α-amylase (1,4 α-D for snack foods as defined in glucan glucanohydrolase (E.C. 3.2.1.1)). § 170.3(n)(37) of this chapter; and 0.02 (b) The ingredient meets the general percent or less for all other food cat- and additional requirements for en- egories. zyme preparations in the ‘‘Food Chemi- (e) Prior sanctions for adipic acid dif- cals Codex,’’ 3d ed. (1981), pp. 107–110, ferent from the uses established in this which is incorporated by reference in section do not exist or have been accordance with 5 U.S.C. 552(a) and 1 waived. CFR part 51. Copies are available from [47 FR 27810, June 25, 1982] the National Academy Press, 2101 Con- stitution Ave. NW., Washington, DC § 184.1011 Alginic acid. 20418, or may be examined at the Office (a) Alginic acid is a colloidal, hydro- of Premarket Approval (HFS–200), Cen- philic polysaccharide obtained from ter for Food Safety and Applied Nutri- certain brown algae by alkaline extrac- tion, Food and Drug Administration, tion. 1110 Vermont Ave. NW., suite 1200, (b) The ingredient meets the speci- Washington, DC, or the Office of the fications of the Food Chemicals Codex, Federal Register, 800 North Capitol St. 3d Ed. (1981), p. 13, which is incor- NW., suite 700, Washington, DC. 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 practices. The affirma- spection at the Office of the Federal tion of this ingredient as GRAS as a di- Register, 800 North Capitol Street, rect human food ingredient is based NW., suite 700, Washington, DC 20408. upon the following current good manu- (c) In accordance with § 184.1(b)(2), facturing practice conditions of use: the ingredient is used in food only (1) The ingredient is used as an en- within the following specific limita- zyme, as defined in § 170.3(o)(9) of this tions: chapter, in the hydrolysis of edible starch to produce maltodextrins and Maximum level of Category of food use in food (as Functional use nutritive carbohydrate sweeteners. served) (2) The ingredient is used at levels not to exceed current good manufac- Soup and soup Not to exceed cur- Emulsifier, emulsi- mixes, rent good manu- fier salt, turing practices. ¤ 170.3(n) (40) facturing prac- ¤ 170.3(o)(8) of of this chapter. tice. this chapter; for- [60 FR 55789, Nov. 3, 1995] mulation aid, ¤ 170.3(o)(14) of § 184.1021 Benzoic acid. this chapter; sta- bilizer, thickener, (a) Benzoic acid is the chemical ¤ 170.3(o)(28) of benzenecarboxylic acid (C7H6O2), occur- this chapter. ring in nature in free and combined
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forms. Among the foods in which ben- stitution Ave. NW., Washington, DC, or zoic acid occurs naturally are cran- may be examined at the Office of Pre- berries, prunes, plums, cinnamon, ripe market Approval (HFS–200), Food and cloves, and most berries. Benzoic acid Drug Administration, 200 C St. SW., is manufactured by treating molten Washington, DC, and the Office of the phthalic anhydride with steam in the Federal Register, 800 North Capitol St. presence of a zinc oxide catalyst, by NW., suite 700, Washington, DC. the hydrolysis of benzotrichloride, or (c) In accordance with § 184.1(b)(1), by the oxidation of toluene with nitric the ingredient is used in food with no acid or sodium bichromate or with air limitation other than current good in the presence of a transition metal manufacturing practice. The affirma- salt catalyst. tion of this ingredient as GRAS as a di- (b) The ingredient meets the speci- rect food ingredient is based upon the fications of the ‘‘Food Chemicals following current good manufacturing Codex,’’ 3d Ed. (1981), p. 35, which is in- practice conditions of use: corporated by reference. Copies may be (1) The ingredient is used as an en- obtained from the National Academy zyme as defined in § 170.3(o)(9) of this Press, 2101 Constitution Ave. NW., chapter to hydrolyze proteins or Washington, DC 20418, or may be exam- polypeptides. ined at the Office of the Federal Reg- (2) The ingredient is used in food at ister, 800 North Capitol Street, NW., levels not to exceed current good man- suite 700, Washington, DC 20408. ufacturing practice. (c) The ingredient is used as an anti- [60 FR 32910, June 26, 1995] microbial agent as defined in § 170.3(o)(2) of this chapter, and as a fla- § 184.1025 Caprylic acid. voring agent and adjuvant as defined in (a) Caprylic acid [CH (CH ) COOH, § 170.3(o)(12) of this chapter. 3 2 6 CAS Reg. No. 124–07–2] is the chemical (d) The ingredient is used in food at name for octanoic acid. It is considered levels not to exceed good manufac- to be a short or medium chain fatty turing practice. Current usage results acid. It occurs normally in various in a maximum level of 0.1 percent in foods and is commercially prepared by food. (The Food and Drug Administra- oxidation of n-octanol or by fermenta- tion has not determined whether sig- tion and fractional distillation of the nificantly different conditions of use volatile fatty acids present in coconut would be GRAS). oil. (e) Prior sanctions for this ingredient (b) The ingredient meets the speci- different from those uses established in fications of the ‘‘Food Chemicals this section, or different from that set Codex,’’ 3d Ed. (1981), p. 207, which is in- forth in part 181 of this chapter, do not corporated by reference. Copies may be exist or have been waived. obtained from the National Academy [42 FR 14653, Mar. 15, 1977, as amended at 49 Press, 2101 Constitution Ave. NW., FR 5610, Feb. 14, 1984] Washington, DC 20418, or may be exam- ined at the Office of the Federal Reg- § 184.1024 Bromelain. ister, 800 North Capitol Street, NW., (a) Bromelain (CAS Reg. No. 9001–00– suite 700, Washington, DC 20408. 7) is an enzyme preparation derived (c) The ingredient is used as a fla- from the pineapples Ananas comosus voring agent and adjuvant as defined in and A. bracteatus L. It is a white to § 170.3(o)(12) of this chapter. light tan amorphous powder. Its char- (d) The ingredient is used in foods in acterizing enzyme activity is that of a accordance with § 184.1(b)(1), at levels peptide hydrolase (EC 3.4.22.32). not to exceed good manufacturing (b) The ingredient meets the general practice. Current good manufacturing requirements and additional require- practices result in maximum levels, as ments for enzyme preparations in the served, of: 0.013 percent for baked goods Food Chemicals Codex, 3d ed. (1981), p. as defined in § 170.3(n)(1) of this chap- 110, which is incorporated by reference ter; 0.04 percent for cheeses as defined in accordance with 5 U.S.C. 552(a) and 1 in § 170.3(n)(5) of this chapter; 0.005 per- CFR part 51. Copies are available from cent for fats and oils as defined in the National Academy Press, 2101 Con- § 170.3(n)(12) of this chapter, for frozen
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dairy desserts as defined in § 170.3(n)(20) § 184.1033 Citric acid. of this chapter, for gelatins and pud- (a) Citric acid (C H O CAS Reg. No. dings as defined in § 170.3(n)(22) of this 6 8 7, 77–92–9) is the compound 2-hydroxy- chapter, for meat products as defined 1,2,3-propanetricarboxylic acid. It is a in § 170.3(n)(29) of this chapter, and for naturally occurring constituent of soft candy as defined in § 170.3(n)(38) of plant and animal tissues. It occurs as this chapter; 0.016 percent for snack colorless crystals or a white powder foods as defined in § 170.3(n)(37) of this and may be anhydrous or contain one chapter; and 0.001 percent or less for all mole of water per mole of citric acid. other food categories. Citric acid may be produced by recov- (e) Prior sanctions for this ingredient ery from sources such as lemon or pine- different from the uses established in apple juice; by mycological fermenta- this section do not exist or have been tion using Candida spp., described in waived. §§ 173.160 and 173.165 of this chapter; and [43 FR 19843, May 9, 1978, as amended at 49 by the solvent extraction process de- FR 5611, Feb. 14, 1984] scribed in § 173.280 of this chapter for the recovery of citric acid from Asper- § 184.1027 Mixed carbohydrase and gillus niger fermentation liquor. protease enzyme product. (b) The ingredient meets the speci- (a) Mixed carbohydrase and protease fications of the Food Chemicals Codex, enzyme product is an enzyme prepara- 3d ed. (1981), pp. 86–87, and its third sup- tion that includes carbohydrase and plement (March 1992), pp. 107–108, which protease activity. It is obtained from are incorporated by reference in ac- the culture filtrate resulting from a cordance with 5 U.S.C. 552(a) and 1 CFR pure culture fermentation of a non- part 51. Copies are available from the pathogenic strain of B. licheniformis. National Academy Press, 2101 Constitu- (b) The ingredient meets the speci- tion Ave. NW., Washington, DC 20418, fications of the Food Chemicals Codex, and the Center for Food Safety and Ap- 3d Ed. (1981), p. 107, which is incor- plied Nutrition (HFS–200), 200 C St. porated by reference. Copies are avail- SW., Washington, DC 20204, or may be able from the National Academy Press, examined at the Office of the Federal 2101 Constitution Ave. NW., Wash- Register, 800 North Capitol St. NW., ington, DC 20418, or available for in- suite 700, Washington, DC. spection at the Office of the Federal (c) In accordance with § 184.1(b)(1), Register, 800 North Capitol Street, the ingredient is used in food with no NW., suite 700, Washington, DC 20408. limitations other than current good (c) In accordance with § 184.1(b)(1), manufacturing 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 as a direct human food [59 FR 63895, Dec. 12, 1994] ingredient is based upon the following current good manufacturing practice § 184.1034 Catalase (bovine liver). conditions of use: (a) Catalase (bovine liver) (CAS Reg. (1) The ingredient is used as an en- No. 9001–05–2) is an enzyme preparation zyme, as defined in § 170.3(o)(9) of this obtained from extracts of bovine liver. chapter, to hydrolyze proteins or car- It is a partially purified liquid or pow- bohydrates. der. Its characterizing enzyme activity (2) The ingredient is used in the fol- is catalase (EC 1.11.1.6). lowing foods at levels not to exceed (b) The ingredient meets the general current good manufacturing practice: requirements and additional require- alcoholic beverages, as defined in ments for enzyme preparations in the § 170.3(n)(2) of this chapter, candy, nu- Food Chemicals Codex, 3d ed. (1981), p. tritive sweeteners, and protein 110, which is incorporated by reference hydrolyzates. in accordance with 5 U.S.C. 552(a) and 1 [48 FR 240, Jan. 4, 1983] CFR part 51. Copies are available from
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the National Academy Press, 2101 Con- § 170.3(o)(2) of this chapter; a curing and stitution Ave., NW., Washington, DC pickling agent as defined in § 170.3(o)(5) 20418, or may be examined at the Office of this chapter; a flavor enhancer as de- of Premarket Approval (HFS–200), Food fined in § 170.3(o)(11) of this chapter; a and Drug Administration, 200 C St., flavoring agent and adjuvant as defined SW., Washington, DC, and the Office of in § 170.3(o)(12) of this chapter; a pH the Federal Register, 800 North Capitol control agent as defined in § 170.3(o)(23) St. NW., suite 700, 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 (d) Prior sanctions for this ingredient practice conditions of use: different from the uses established in (1) The ingredient is used as an en- this section do not exist or have been zyme as defined in § 170.3(o)(9) of this waived. chapter to decompose hydrogen per- [49 FR 35367, Sept. 7, 1984] oxide. (2) The ingredient is used in food at § 184.1063 Enzyme-modified lecithin. levels not to exceed current good man- (a) Enzyme-modified lecithin is pre- ufacturing practice. pared by treating lecithin with either [60 FR 32910, June 26, 1995] phospholipase A2 (EC 3.1.1.4) or pan- creatin. § 184.1061 Lactic acid. (b) The ingredient meets the speci- (a) Lactic acid (C3H6O3, CAS Reg. fications in paragraphs (b)(1) through Nos.: DL mixture, 598–82–3; L-isomer, 79– (b)(8) of this section. Unless otherwise 33–4; D-isomer, 10326–41–7), the chemical noted, compliance with the specifica- 2-hydroxypropanoic acid, occurs natu- tions listed below is determined ac- rally in several foods. It is produced cording to the methods set forth for commercially either by fermentation lecithin in the Food Chemicals Codex, of carbohydrates such as glucose, su- 4th ed. (1996), pp. 220–221, which are in- crose, or lactose, or by a procedure in- corporated by reference in accordance volving formation of lactonitrile from with 5 U.S.C. 552(a) and 1 CFR part 51. acetaldehyde and hydrogen cyanide Copies are available from the National and subsequent hydrolysis to lactic Academy Press, 2101 Constitution Ave. acid. NW., Washington DC 20418, or may be (b) The ingredient meets the speci- examined at the Center for Food Safety fications of the Food Chemicals Codex, and Applied Nutrition’s Library, 200 C 3d Ed. (1981), p. 159, which is incor- St. SW., rm. 3321, Washington, DC, or porated by reference. Copies are avail- at the Office of the Federal Register, able from the National Academy Press, 800 North Capitol St. NW., suite 700, 2101 Constitution Avenue, NW., Wash- Washington, DC. ington, DC 20418, or available for in- (1) Acetone-insoluble matter spection at the Office of the Federal (phosphatides), not less than 50.0 per- Register, 800 North Capitol Street, cent. NW., suite 700, Washington, DC 20408. (2) Acid value, not more than 40. (c) In accordance with § 184.1(b)(1), (3) Lead, not more than 1.0 part per the ingredient is used in food with no million, as determined by atomic ab- limitation other than current good sorption spectroscopy. manufacturing practice. The affirma- (4) Heavy metals (as Pb), not more tion of this ingredient as generally rec- than 20 parts per million. ognized as safe (GRAS) as a direct (5) Hexane-insoluble matter, not human food ingredient is based upon more than 0.3 percent. the following current good manufac- (6) Peroxide value, not more than 20. turing practice conditions of use: (7) Water, not more than 4.0 percent. (1) The ingredient is used as an anti- (8) Lysolecithin, 50 to 80 mole percent microbial agent as defined in of total phosphatides as determined by
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‘‘Determination of Lysolecithin Con- manufacturing practice. The affirma- tent of Enzyme-Modified Lecithin: tion of this ingredient as generally rec- Method I,’’ dated 1985, which is incor- ognized as safe (GRAS) as a direct porated by reference in accordance human food ingredient is based upon with 5 U.S.C. 552(a) and 1 CFR part 51. the following current good manufac- Copies are available from the Division turing practice conditions of use: of Petition Control, Center for Food (1) The ingredient is used as a fla- Safety and Applied Nutrition (HFS– voring agent and adjuvant as defined in 215), Food and Drug Administration, § 170.3(o)(12) of this chapter and as a nu- 200 C St. SW., Washington, DC 20204, or trient supplement as defined in may be examined at the Center for § 170.3(o)(20) of this chapter. Food Safety and Applied Nutrition’s (2) The ingredient is used in foods at Library, 200 C St. SW., rm. 3321, Wash- levels not to exceed current good man- ington, DC, or at the Office of the Fed- eral Register, 800 North Capitol St. ufacturing practice. The ingredient NW., suite 700, Washington, 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 ingredient is based upon the following this section do not exist or have been current good manufacturing practice waived. conditions of use: [49 FR 48534, Dec. 13, 1984] (1) The ingredient is used as an emul- sifier as defined in § 170.3(o)(8) of this § 184.1069 Malic acid. chapter. (2) The ingredient is used at levels (a) Malic acid (C4H6O5, CAS Reg. No. not to exceed current good manufac- of L-form 97–67–6, CAS Reg. No. of DL- turing practice. form 617–48–1) is the common name for 1-hydroxy-1, 2-ethanedicarboxylic acid. [61 FR 45889, Aug. 30, 1996] L (+) malic acid, referred to as L-malic § 184.1065 Linoleic acid. acid, occurs naturally in various foods. Racemic DL-malic acid does not occur (a) Linoleic acid ((Z, Z)–9, 12-octadec- naturally. It is made commercially by adienoic acid (C17H31COOH) (CAS Reg. hydration of fumaric acid or maleic No. 60–33–3)), a straight chain unsatu- acid. rated fatty acid with a molecular (b) The ingredient meets the speci- weight of 280.5, is a colorless oil at room temperature. Linoleic acid may fications of the ‘‘Food Chemicals be prepared from edible fats and oils by Codex,’’ 3d Ed. (1981), pp. 183–184, which various methods including hydrolysis is incorporated by reference. Copies and saponification, the Twitchell may be obtained from the National method, low pressure splitting with Academy Press, 2101 Constitution Ave. catalyst, continuous high pressure NW., Washington, DC 20418, or may be counter current splitting, and medium examined at the Office of the Federal pressure autoclave splitting with cata- Register, 800 North Capitol Street, lyst. NW., suite 700, Washington, DC 20408. (b) FDA is developing food-grade (c) The ingredients are used as a fla- specifications for linoleic acid in co- vor enhancer as defined in § 170.3(o)(11) operation with the National Academy of this chapter, flavoring agent and ad- of Sciences. In the interim, this ingre- juvant as defined in § 170.3(o)(12) of this dient must be of a purity suitable for chapter, and pH control agent as de- its intended use. The ingredient must fined in § 170.3(o)(23) of this chapter. also meet the specifications in (d) The ingredients are used in food, § 172.860(b) of this chapter. except baby food, at levels not to ex- (c) In accordance with § 184.1(b)(1), ceed good manufacturing practice in the ingredient is used in food with no accordance with § 184.1(b)(1). Current limitation other than current good good manufacturing practice results in
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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. (d) Prior sanctions for this ingredient § 184.1077 Potassium acid tartrate. different from the uses established in (a) Potassium acid tartrate (C4H5KO6, this section do not exist or have been CAS Reg. No. 868–14–4) is the potassium waived. acid salt of L¥(+)¥tartaric acid and is [48 FR 52446, Nov. 18, 1983] also called potassium bitartrate or cream of tartar. It occurs as colorless § 184.1081 Propionic acid. or slightly opaque crystals or as a white, crystalline powder. It has a (a) Propionic acid (C3H6O2, CAS Reg. pleasant, acid taste. It is obtained as a No. 79–09–4) is an oily liquid having a byproduct of wine manufacture. slightly pungent, rancid odor. It is (b) The ingredient meets the speci- manufactured by chemical synthesis or fications of the Food Chemicals Codex, by bacterial fermentation. 3d Ed. (1981), P. 238, 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. 254, 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)(1), Register, 800 North Capitol Street, the ingredient is used in food with no NW., suite 700, Washington, DC 20408. 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 a 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 an the following current good manufac- anticaking agent as defined in turing practice conditions of use: § 170.3(o)(1) of this chapter; an anti- (1) The ingredient is used as an anti- microbial agent as defined in microbial agent as defined in § 170.3(o)(2) of this chapter; a formula- § 170.3(o)(2) of this chapter and a fla- tion aid as defined in § 170.3(o)(14) of voring agent as defined in § 170.3(o)(12) this chapter; a humectant as defined in of this chapter.
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(2) The ingredient is used in foods at § 184.1091 Succinic acid. levels not to exceed current good man- (a) Succinic acid (C H O CAS Reg. ufacturing practice. 4 6 4, No. 110–15–6), also referred to as amber (d) Prior sanctions for this ingredient acid and ethylenesuccinic acid, is the different from the uses established in chemical 1,4-butanedioic acid. It is this section do not exist or have been commercially prepared by hydro- waived. genation of maleic or fumaric acid. It [49 FR 13141, Apr. 3, 1984] can also be produced by aqueous alkali or acid hydrolysis of succinonitrile. § 184.1090 Stearic acid. (b) The ingredient meets the speci- (a) Stearic acid (C H O CAS Reg. fications of the ‘‘Food Chemicals 16 36 2, Codex,’’ 3d Ed. (1981), pp. 314–315, which 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. (b) The ingredient meets the speci- (d) The ingredient is used in food at fications of the Food Chemicals Codex, levels not to exceed good manufac- 3d Ed. (1981), p. 313, which is incor- turing practice in accordance with porated by reference, and the require- § 184.1(b)(1). Current good manufac- ments of § 172.860(b)(2) of this chapter. turing practice results in a maximum Copies of the Food Chemicals Codex level, as served, of 0.084 percent in con- are available from the National Acad- diments and relishes as defined in emy Press, 2101 Constitution Ave. NW., § 170.3(n)(8) of this chapter and 0.0061 Washington, DC 20418, or available for percent in meat products as defined in inspection at the Office of the Federal § 170.3(n)(29) of this chapter. Register, 800 North Capitol Street, (e) 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 [44 FR 20657, Apr. 6, 1979, as amended at 49 manufacturing practice. The affirma- FR 5611, Feb. 14, 1984] tion of this ingredient as generally rec- ognized as safe (GRAS) as a direct § 184.1095 Sulfuric acid. human food ingredient is based upon (a) Sulfuric acid (H2SO4, CAS Reg. the following current good manufac- No. 7664–93–9), also known as oil of vit- turing practice conditions of use: riol, is a clear, colorless, oily liquid. It (1) The ingredient is used as a fla- is prepared by reacting sulfur dioxide voring agent and adjuvant as defined in (SO2) with oxygen and mixing the re- § 170.3(o)(12) of this chapter. sultant sulfur trioxide (SO3) with (2) The ingredient is used in foods at water, or by reacting nitric oxide (NO) levels not to exceed current good man- with sulfur dioxide and water. ufacturing practice. (b) The ingredient meets the speci- (d) Prior sanctions for this ingredient fications of the ‘‘Food Chemicals different from the uses established in Codex,’’ 3d Ed. (1981), pp. 317–318, which this section do not exist or have been is incorporated by reference. Copies waived. may be obtained from the National Academy Press, 2101 Constitution Ave. [48 FR 52445, Nov. 18, 1983, as amended at 50 NW., Washington, DC 20418, or may be FR 49536, Dec. 3, 1985] examined at the Office of the Federal
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Register, 800 North Capitol Street, light brown substance in the form of an NW., suite 700, Washington, DC 20408. amorphous, bulky powder, glistening (c) The ingredient is used as a pH scales, or spongy masses. It is also control agent as defined in § 170.3(o)(23) ordorless, or has a faint characteristic of this chapter and processing aid as odor, and has an astringent taste. Tan- defined in § 170.3(o)(24) of this chapter. nic acid is obtained by solvent extrac- (d) The ingredient is used in food at tion of nutgalls or excrescences that levels not to exceed good manufac- form on the young twigs of Quercus turing practice in accordance with infectoria Oliver and related species of § 184.1(b)(1). Current good manufac- Quercus. Tannic acid is also obtained turing practice results in a maximum by solvent extraction of the seed pods level, as served, of 0.014 percent for al- coholic beverages as defined in of Tara (Caesalpinia spinosa) or the § 170.3(n)(2) of this chapter and 0.0003 nutgalls of various sumac species, in- percent for cheeses as defined in cluding Rhus semialata, R. coriaria, R. § 170.3(n)(5) of this chapter. galabra, and R. typhia. (e) 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. 319, which is incor- waived. porated by reference. Copies are avail- able from the National Academy Press, [45 FR 6085, Jan. 25, 1980, as amended at 49 FR 5611, Feb. 14, 1984] 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- § 184.1097 Tannic acid. spection at the Office of the Federal (a) Tannic acid (CAS Reg. No. 1401– Register, 800 North Capitol Street, 55–4), or hydrolyzable gallotannin, is a NW., suite 700, Washington, DC 20408. complex polyphenolic organic struc- (c)(1) In accordance with § 184.1(b)(2), ture that yields gallic acid and either the ingredient is used in food only glucose or quinic acid as hydrolysis within the following specific limita- products. It is a yellowish-white to tions:
Maximum level of use Category of food in food (as Functional use served) (per- cent)
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; fla- voring agent and adjuvant, ¤ 170.3(o)(12) of this chapter; processing aid, ¤ 170.3(o)(24) of this chap- ter. 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. 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- § 184.1099 Tartaric acid. dered animal fat in accordance with 9 (a) Food grade tartaric acid (C H O CFR 318.7. 4 6 6, CAS Reg. No. 87–69–4) has the L con- (d) Prior sanctions for this ingredient figuration. The L form of tartaric acid different from the uses established in is dextrorotatory in solution and is this section do not exist or have been also known as L¥(+)¥tartaric acid. waived. Tartaric acid occurs as colorless or [50 FR 21043, May 22, 1985] translucent crystals or as a white, crystalline powder. It is odorless and
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has an acid taste. It is obtained as a 2101 Constitution Avenue NW., Wash- byproduct of wine manufacture. 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. 320, which is incor- NW., suite 700, Washington, DC 20005. 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 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 in food as tion of this ingredient as generally rec- an emulsifier and emulsifier salt as de- ognized as safe (GRAS) as a direct fined in § 170.3(o)(8) of this chapter and human food ingredient is based upon a flavoring agent and adjuvant as de- the following current good manufac- fined in § 170.3(o)(12) of this chapter. turing practice conditions of use: (2) The ingredient is used in the fol- (1) The ingredient is used as a firm- lowing foods at levels not to exceed ing agent as defined in § 170.3(o)(10) of current good manufacturing practice: this chapter; a flavor enhancer as de- baked goods and baking mixes as de- fined in § 170.3(o)(11) of this chapter; a fined in § 170.3(n)(l) of this chapter; flavoring agent as defined in nonalcoholic beverages as defined in § 170.3(o)(12) of this chapter; a humec- § 170.3(n)(3) of this chapter; confections tant as defined in § 170.3(o)(16) of this and frostings as defined in § 170.3(n)(9) chapter; and a pH control agent as de- of this chapter; dairy product analogs fined in § 170.3(o)(23) of this chapter. (2) The ingredient is used in foods at as defined in § 170.3(n)(10) of this chap- levels not to exceed current good man- ter; and fats and oils as defined in ufacturing practice. § 170.3(n)(12) of this chapter. (d) Prior sanctions for this ingredient (d) Prior sanctions for this ingredient different from the uses established in different from the uses established in this section do not exist or have been this section do not exist or have been waived. waived. [48 FR 52447, Nov. 18, 1983, as amended at 50 (e) Labeling: The acronym ‘‘DATEM’’ FR 49536, Dec. 3, 1985] may be used on food labeling as the al- ternate common or usual name for the § 184.1101 Diacetyl tartaric acid esters ingredient diacetyl tartaric acid esters of mono- and diglycerides. of mono- and diglycerides. (a) Diacetyl tartaric acid esters of [54 FR 7403, Feb. 21, 1989, as amended at 54 mono- and diglycerides, also know as FR 13168, Mar. 31, 1989; 54 FR 18382, Apr. 28, DATEM, are composed of mixed esters 1989; 60 FR 15872, Mar. 28, 1995] of glycerin in which one or more of the hydroxyl groups of glycerin has been § 184.1115 Agar-agar. esterified by diacetyl tartaric acid and by fatty acids. The ingredient is pre- (a) Agar-agar (CAS Reg. No. PM 9002– pared by the reaction of diacetyl tar- 18–0) is a dried, hydrophyllic, colloidal taric anhydride with mono- and polysaccharide extracted from one of a diglycerides that are derived from edi- number of related species of red algae ble sources. (class Rhodophyceae). (b) The ingredient meets the speci- (b) The ingredient meets the speci- fications of the Food Chemicals Codex, fications of the ‘‘Food Chemicals 3d. Ed. (1981), pp. 98–99, which is incor- Codex,’’ 3d Ed. (1981), p. 11, which is in- porated by reference in accordance corporated by reference. Copies may be with 5 U.S.C. 552(a). Copies are avail- obtained from the National Academy able from the National Academy Press, Press, 2101 Constitution Ave. NW.,
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Washington, DC 20418, or may be exam- (c) The ingredient is used in food in ined at the Office of the Federal Reg- accordance with § 184.1(b)(2) under the ister, 800 North Capitol Street, NW., following conditions: suite 700, Washington, DC 20408.
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 Maximum level of Category of food use in food (as Functional use different from the uses established in served) this section do not exist or have been waived. Spices, Not to exceed cur- Flavor enhancer, seasonings, and rent good manu- ¤ 170.3(o)(11) of [44 FR 19391, Apr. 3, 1979, as amended at 49 flavorings, facturing prac- this chapter; fla- FR 5611, Feb. 14, 1984] ¤ 170.3(n) (26) tice. vor adjuvant, of this chapter. ¤ 170.3(o)(12) of this chapter. § 184.1120 Brown algae. (a) Brown algae are seaweeds of the (d) Prior sanctions for this ingredient species Analipus japonicus, Eisenia different from the use established in bicyclis, Hizikia fusiforme, Kjellmaniella this section do not exist or have been gyrata, Laminaria angustata, Laminaria waived. claustonia, Laminaria digitata, Lam- [47 FR 47376, Oct. 26, 1982] inaria japonica, Laminaria longicruris, Laminaria longissima, Laminaria § 184.1121 Red algae. ochotensis, Laminaria saccharina, (a) Red algae are seaweeds of the spe- Macrocystis pyrifera, Petalonia fascia, cies Gloiopeltis furcata, Porphyra Scytosiphon lomentaria and Undaria crispata, Porphyra deutata, Porphyra pinnatifida. They are harvested prin- perforata, Porphyra suborbiculata, cipally in coastal waters of the north- Porphyra tenera and Rhodymenia ern Atlantic and Pacific oceans. The palmata. Porphyra and Rhodymenia are material is dried and ground or harvested principally along the coasts chopped for use in food. of Japan, Korea, China, Taiwan, and (b) The ingredient meets the speci- the East and West coasts of the United States. Gloiopeltis is harvested prin- fications for kelp in the Food Chemi- cipally in southern Pacific coastal wa- cals Codex, 3d Ed. (1981), p. 157, which is ters. The material is dried and ground incorporated by reference. Copies are or chopped for use in food. available from the National Academy (b) The ingredient meets the speci- Press, 2101 Constitution Ave. NW., fications for kelp in the Food Chemi- Washington, DC 20418, or available for cals Codex, 3d Ed. (1981), p. 157, which is inspection at the Office of the Federal incorporated by reference, except that Register, 800 North Capitol Street, the loss on drying is not more than 20 NW., suite 700, Washington, DC 20408. percent and the maximum allowable (c) In accordance with § 184.1(b)(2), level for iodine is 0.05 percent. Copies the ingredient is used in food only are available from the National Acad- within the following specific limita- emy Press, 2101 Constitution Ave. NW., tions: Washington, DC 20418, or available for inspection at the Office of the Federal
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Register, 800 North Capitol Street, Maximum NW., suite 700, Washington, DC 20408. level of use in (c) In accordance with § 184.1(b)(2), Category of food food (as Functional use served) the ingredient is used in food only (percent) within the following specific limita- tions: Jams and jellies, 0.4 Do. ¤ 170.3(n)(28) of this Maximum level of chapter. Category of food use in food (as Functional use Sweet sauces, 0.5 Do. served) ¤ 170.3(n)(43) of this chapter. Spices, Not to exceed cur- Flavor enhancer, All other food cat- 0.1 Humectant, seasonings, and rent good manu- ¤ 170.3(o)(11) of egories. ¤ 170.3(o)(16) of this flavorings, facturing prac- this chapter; fla- chapter; stabilizer, ¤ 170.3(n) (26) tice. vor adjuvant, thickener, of this chapter. ¤ 170.3(o)(12) of ¤ 170.3(o)(28) of this this chapter. chapter.
(d) Prior sanctions for this ingredient (d) Prior sanctions for ammonium al- different from the use established in ginate different from the uses estab- this section do not exist or have been lished in this section do not exist or waived. have been waived. [47 FR 47376, Oct. 26, 1982] [47 FR 29950, July 9, 1982] § 184.1133 Ammonium alginate. § 184.1135 Ammonium bicarbonate. (a) Ammonium alginate (CAS Reg. No. 9005–34–9) is the ammonium salt of (a) Ammonium bicarbonate alginic acid, a natural polyuronide con- (NH4HCO3, CAS Reg. No. 1066–33–7) is stituent of certain brown algae. Ammo- prepared by reacting gaseous carbon di- nium alginate is prepared by the neu- oxide with aqueous ammonia. Crystals tralization of purified alginic acid with of ammonium bicarbonate are precip- appropriate pH control agents. itated from solution and subsequently (b) The ingredient meets the speci- washed and dried. fications of the Food Chemicals Codex, (b) The ingredient meets the speci- 3d Ed. (1981), p. 18, which is incor- fications of the Food Chemicals Codex, porated by reference. Copies are avail- 3d Ed. (1981), p. 19, 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) In accordance with § 184.1(b)(1), within the following specific limita- the ingredient is used in food with no tions: limitation other than current good Maximum manufacturing practice. The affirma- level of tion of this ingredient as generally rec- use in Category of food food (as Functional use ognized as safe (GRAS) as a direct served) (percent) human food ingredient is based upon the following current good manufac- Confections, frostings, 0.4 Stabilizer, thickener, turing practice conditions of use: ¤ 170.3(n)(9) of this ¤ 170.3(o)(28) of this chapter. chapter. (1) The ingredient is used as a dough Fats and oils, 0.5 Do. strengthener as defined in § 170.3(o)(6) ¤ 170.3(n)(12) of this of this chapter; a leavening agent as chapter. Gelatins, puddings, 0.5 Do. defined in § 170.3(o)(17) of this chapter; ¤ 170.3(n)(22) of this a pH control agent as defined in chapter. § 170.3(o)(23) of this chapter; and a Gravies and sauces, 0.4 Do. ¤ 170.3(n)(24) of this texturizer as defined in § 170.3(o)(32) of chapter. this chapter.
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(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, § 184.1137 Ammonium carbonate. 3d Ed. (1981), p. 20, which is incor- 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 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 dough spection at the Office of the Federal strengthener as defined in § 170.3(o)(6) Register, 800 North Capitol Street, of this chapter; a flavor enhancer as de- NW., suite 700, Washington, DC 20408. fined in § 170.3(o)(11) of this chapter; a (c) In accordance with § 184.1(b)(1), leavening agent as defined in the ingredient is used in food with no § 170.3(o)(17) of this chapter; and a proc- limitation other than current good essing aid as defined in § 107.3(o)(24) of manufacturing practice. The affirma- this chapter. 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- (d) Prior sanctions for this ingredient turing practice conditions of use: different from the uses established in (1) The ingredient is used as a leav- this section do not exist or have been ening agent as defined in § 170.3(o)(17) of waived. this chapter and a pH control agent as [48 FR 52439, Nov. 18, 1983] defined in § 170.3(o)(23) of this chapter. (2) The ingredient is used in food at § 184.1139 Ammonium hydroxide. levels not to exceed current good man- ufacturing practice. (a) Ammonium hydroxide (NH4 OH, (d) Prior sanctions for this ingredient CAS Reg. No. 1336–21–6) is produced by different from the uses established in passing ammonia gas into water. 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. 20, which is incor- [48 FR 52439, Nov. 18, 1983] porated by reference. Copies are avail- able from the National Academy Press, § 184.1138 Ammonium chloride. 2101 Constitution Ave. NW., Wash- (a) Ammonium chloride (NH4Cl, CAS ington, DC 20418, or available for in- Reg. No. 12125–02–9) is produced by the spection at the Office of the Federal reaction of sodium chloride and an am- Register, 800 North Capitol Street, monium salt in solution. The less solu- NW., suite 700, Washington, DC 20408. ble sodium salt separates out at ele- (c) In accordance with § 184.1(b)(1), vated temperatures, and ammonium the ingredient is used in food with no
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limitation other than current good chapter at levels not to exceed current manufacturing practice. The affirma- good manufacturing practice. tion of this ingredient as generally rec- (d) Prior sanctions for this ingredient ognized as safe (GRAS) as a direct different from the uses established in human food ingredient is based upon this section, or different from those set the following current good manufac- forth in part 181 of this chapter, do not turing practice conditions of use: exist or have been waived. (1) The ingredient is used as a leav- ening agent as defined in § 170.3(o)(17) of [59 FR 63896, Dec. 12, 1994] this chapter; a pH control agent as de- fined in § 170.3(o)(23) of this chapter; a § 184.1141a Ammonium phosphate, surface-finishing agent as defined in monobasic. § 170.3(o)(30) of this chapter; and as a (a) Ammonium phosphate, monobasic boiler water additive complying with (NH4H2PO4, CAS Reg. No. 7722–76–1) is § 173.310 of this chapter. manufactured by reacting ammonia (2) The ingredient is used in food at with phosphoric acid at a pH below 5.8. levels not to exceed current good man- (b) The ingredient meets the speci- ufacturing practice. The ingredient fications of the Food Chemicals Codex, may also be used as a boiler water ad- 3d Ed. (1981), p. 21, which is incor- ditive at levels not to exceed current porated by reference. Copies are avail- good manufacturing practice. able from the National Academy Press, (d) Prior sanctions for this ingredient 2101 Constitution Ave. NW., Wash- different from the uses established in this section do not exist or have been ington, DC 20418, or available for in- waived. spection at the Office of the Federal Register, 800 North Capitol Street, [48 FR 52440, Nov. 18, 1983, as amended at 59 NW., suite 700, Washington, DC 20408. FR 14551, Mar. 29, 1994] (c) In accordance with § 184.1(b)(1), § 184.1140 Ammonium citrate, dibasic. the ingredient is used in food with no limitation other than current good (a) Ammonium citrate, dibasic manufacturing practice. The affirma- ((NH ) HC H O CAS Reg. No. 3012–65–5) 4 2 6 5 7, tion of this ingredient as generally rec- is the diammonium salt of citric acid. ognized as safe (GRAS) as a direct It is prepared by partially neutralizing human food ingredient is based upon citric acid with ammonia. the following current good manufac- (b) The Food and Drug Administra- tion, in cooperation with the National turing practice conditions of use: Academy of Sciences, is developing (1) The ingredient is used as a dough food-grade specifications for ammo- strengthener as defined in § 170.3(o)(6) nium citrate, dibasic. In the interim, of this chapter and a pH control agent this ingredient must be of a purity as defined in § 170.3(o)(23) of this chap- suitable for its intended use. ter. (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 manufac- turing practice conditions of use: [48 FR 52440, Nov. 18, 1983] (1) The ingredient is used as a flavor § 184.1141b Ammonium phosphate, di- enhancer as defined in § 170.3(o)(11) of basic. this chapter and as a pH control agent as defined in § 170.3(o)(23) of this chap- (a) Ammonium phosphate, dibasic ter. ((NH4)2HPO4, CAS Reg. No. 7783–28–0) is (2) The ingredient is used in non- manufactured by reacting ammonia alcoholic beverages as defined in with phosphoric acid at a pH above 5.8. § 170.3(n)(3) of this chapter and in (b) The ingredient meets the speci- cheeses as defined in § 170.3(n)(5) of this fications of the Food Chemicals Codex,
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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 [45 FR 6086, Jan. 25, 1980; 45 FR 16469, Mar. 14, the following current good manufac- 1980, as amended at 49 FR 5611, Feb. 14, 1984] turing practice conditions of use: (1) The ingredient is used as a dough § 184.1148 Bacterially-derived strengthener as defined in § 170.3(o)(6) carbohydrase enzyme preparation. of this chapter; a firming agent as de- (a) Bacterially-derived carbohydrase fined in § 170.3(o)(10) of this chapter; a enzyme preparation is obtained from leavening agent as defined in the culture filtrate resulting from a § 170.3(o)(17) of this chapter; a pH con- pure culture fermentation of a non- trol agent as defined in § 170.3(o)(23) of pathogenic and nontoxigenic strain of this chapter; and a processing aid as Bacillus subtilis or B. amyloliquefaciens. defined in § 170.3(o)(24) of this chapter. The preparation is characterized by the (2) The ingredient is used in food at presence of the enzymes α-amylase (EC levels not to exceed current good man- 3.2.1.1) and β-glucanase (EC 3.2.1.6), ufacturing practice. which catalyze the hydrolysis of O- (d) Prior sanctions for this ingredient glycosyl bonds in carbohydrates. different from the uses established in (b) The ingredient meets the general this section do not exist or have been requirements and additional require- waived. ments in the monograph on enzyme preparations in the Food Chemicals [48 FR 52440, Nov. 18, 1983] Codex, 4th ed. (1996), pp. 128–135, which is incorporated by reference in accord- § 184.1143 Ammonium sulfate. ance with 5 U.S.C. 552(a) and 1 CFR (a) Ammonium sulfate ((NH4)2SO4, part 51. Copies are available from the CAS Reg. No. 7783–20–2) occurs natu- National Academy Press, 2101 Constitu- rally and consists of colorless or white, tion Ave. NW., Washington, DC 20418, odorless crystals or granules. It is pre- or may be examined at the Center for pared by the neutralization of sulfuric Food Safety and Applied Nutrition’s acid with ammonium hydroxide. Library, 200 C St. SW., rm. 3321, Wash- (b) The ingredient meets the speci- ington, DC, or at the Office of the Fed- fications of the ‘‘Food Chemicals eral Register, 800 North Capitol Street, Codex,’’ 3d Ed. (1981), pp. 22–23, which is NW., Suite 700, Washington, DC. In ad- incorporated by reference. Copies may dition, antibiotic activity is absent in be obtained from the National Acad- the enzyme preparation when deter- emy Press, 2101 Constitution Ave. NW., mined by an appropriate validated Washington, DC 20418, or may be exam- method such as the method ‘‘Deter- ined at the Office of the Federal Reg- mination of antibiotic activity’’ in the ister, 800 North Capitol Street, NW., Compendium of Food Additive Speci- suite 700, Washington, DC 20408. fications, vol. 2, Joint FAO/WHO Ex- (c) The ingredient is used as a dough pert Committee on Food Additives strengthener as defined in § 170.3(o)(6) (JECFA), Food and Agriculture Organi- of this chapter, firming agent as de- zation of the United Nations, Rome, fined in § 170.3(o)(10) of this chapter, 1992. Copies are available from Bernan and processing aid as defined in Associates, 4611–F Assembly Dr., § 170.3(o)(24) of this chapter. Lanham, MD 20706, or from The United
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Nations Bookshop, General Assembly fications, vol. 2, Joint FAO/WHO Ex- Bldg., rm. 32, New York, NY 10017, or pert Committee on Food Additives by inquiries sent to ‘‘http:// (JECFA), Food and Agriculture Organi- www.fao.org’’. Copies may be examined zation of the United Nations, Rome, at the Center for Food Safety and Ap- 1992. Copies are available from Bernan plied Nutrition’s Library, 200 C St. Associates, 4611–F Assembly Dr., SW., rm. 3321, Washington, DC. Lanham, MD 20706, or from The United (c) In accordance with § 184.1(b)(1), Nations Bookshop, General Assembly the ingredient is used in food with no Bldg., rm. 32, New York, NY 10017, or limitation other than current good by inquiries sent to ‘‘http:// manufacturing practice. The affirma- www.fao.org’’. Copies may be examined tion of this ingredient as GRAS as a di- at the Center for Food Safety and Ap- rect food ingredient is based upon the plied Nutrition’s Library, 200 C St. following current good manufacturing SW., rm. 3321, 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 polysaccharides manufacturing practice. The affirma- (e.g., starch). 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: (1) The ingredient is used as an en- [64 FR 19894, Apr. 23, 1999] zyme as defined in § 170.3(o)(9) of this § 184.1150 Bacterially-derived protease chapter to hydrolyze proteins or enzyme preparation. polypeptides. (a) Bacterially-derived protease en- (2) The ingredient is used in food at zyme preparation is obtained from the levels not to exceed current good man- culture filtrate resulting from a pure ufacturing practice. culture fermentation of a nonpatho- [64 FR 19895, Apr. 23, 1999] genic and nontoxigenic strain of Bacil- lus subtilis or B. amyloliquefaciens. The § 184.1155 Bentonite.
preparation is characterized by the (a) Bentonite (Al2O34SiO2nH2O, CAS presence of the enzymes subtilisin (EC Reg. No. 1302–0978–099) is principally a 3.4.21.62) and neutral proteinase (EC colloidal hydrated aluminum silicate. 3.4.24.28), which catalyze the hydrolysis Bentonite contains varying quantities of peptide bonds in proteins. of iron, alkalies, and alkaline earths in (b) The ingredient meets the general the commercial products. Depending on requirements and additional require- the cations present, natural deposits of ments in the monograph on enzyme bentonite range in color from white to preparations in the Food Chemicals gray, yellow, green, or blue. Codex, 4th ed. (1996), pp. 128–135, which Bentonite’s fine particles provide large is incorporated by reference in accord- total surface area and, hence, pro- ance with 5 U.S.C. 552(a) and 1 CFR nounced adsorptive capability. part 51. Copies are available from the (b) FDA is developing food-grade National Academy Press, 2101 Constitu- specifications for bentonite in coopera- tion Ave. NW., Washington, DC 20418, tion with the National Academy of or may be examined at the Center for Sciences. In the interim, the ingredient Food Safety and Applied Nutrition’s must be of a suitable purity for its in- Library, 200 C St. SW., rm. 3321, Wash- tended use. ington, DC, or at the Office of the Fed- (c) In accordance with § 184.1(b)(1), eral Register, 800 North Capitol Street, the ingredient is used in food with no NW., Suite 700 Washington, DC. In ad- limitation other than current good dition, antibiotic activity is absent in manufacturing practice. The affirma- the enzyme preparation when deter- tion of this ingredient as generally rec- mined by an appropriate validated ognized as safe (GRAS) as a direct method such as the method ‘‘Deter- human food ingredient is based upon mination of antibiotic activity’’ in the the following current good manufac- Compendium of Food Additive Speci- turing practice conditions of use:
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(1) The ingredient is used as a proc- fications for whey, concentrated whey, essing aid as defined in § 170.3(o)(24) of or dried whey in § 184.1979(a) (1), (2), or this chapter. (3), respectively. (2) The ingredient is used in food at (d) Prior sanctions for this ingredient levels not to exceed current good man- different from the uses established in ufacturing practice. Current good man- this section do not exist or have been ufacturing practice results in no sig- waived. nificant residue in foods. (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- ical formula C H CAS Reg. Nos. 106– [47 FR 43367, Oct. 1, 1982] 4 10, 97–8 and 75–28–5, respectively) are color- § 184.1157 Benzoyl peroxide. less, odorless, flammable gases at nor- mal temperatures and pressures. They (a) Benzoyl peroxide ((C H CO) O 6 5 2 2, are easily liquefied under pressure at CAS Reg. No. 94–36–0) is a colorless, room temperature and are stored and rhombic crystalline solid. It is pre- pared by reaction of benzoyl chloride, shipped in the liquid state. The butanes sodium hydroxide, and hydrogen per- are obtained from natural gas by frac- oxide. tionation following absorption in oil, (b) The ingredient meets the speci- adsorption to surface-active agents, or fications of the Food Chemicals Codex, refrigeration. 3d Ed. (1981), p. 35, which is incor- (b) The Food and Drug Administra- porated by reference. Copies are avail- tion is developing food-grade specifica- able from the National Academy Press, tions for n-butane and iso-butane in co- 2101 Constitution Ave. NW., Wash- operation with the National Academy ington, DC 20418, or available for in- of Sciences. In the interim, the ingredi- spection at the Office of the Federal ents must be of a purity suitable for Register, 800 North Capitol Street, their intended use. NW., suite 700, Washington, DC 20408. (c) In accordance with § 184.1(b)(1), (c) In accordance with § 184.1(b)(1), these ingredients are used in food with the ingredient is used in food with no no limitations other than current good limitation other than current good manufacturing practice. The affirma- manufacturing practice. The affirma- tion of these ingredients as generally tion of this ingredient as generally rec- recognized as safe (GRAS) as direct ognized as safe (GRAS) as a direct human food ingredients is based upon human food ingredient is based upon the following current good manufac- the following current good manufac- turing practice conditions of use: turing practice conditions of use: (1) The ingredients are used as pro- (1) The ingredient is used as a bleach- pellants, aerating agents, and gases as ing agent in food. defined in § 170.3(o)(25) of this chapter. (2) The ingredient is used in the fol- (2) The ingredients are used in food lowing foods at levels not to exceed at levels not to exceed current good current good manufacturing practice: manufacturing practice. flour; milk used for production of (d) Prior sanctions for these ingredi- Asiago fresh and Asiago soft cheese ents different from the uses established (§ 133.102), Asiago medium cheese in this section do not exist or have (§ 133.103), Asiago old cheese (§ 133.104), been waived. Blue cheese (§ 133.106), Caciocavallo siciliano chesse (§ 133.111), Gorgonzola [48 FR 57270, Dec. 29, 1983] cheese (§ 133.141), Parmesan and reggiano cheese (§ 133.165), Provolone § 184.1185 Calcium acetate. cheese (§ 133.181), Romano cheese (a) Calcium acetate (Ca (C2H3O2)2, (§ 133.183), and Swiss and emmentaler CAS Reg. No. 62–54–4), also known as cheese (§ 133.195) in part 133 of this acetate of lime or vinegar salts, is the chapter; and annatto-colored whey, calcium salt of acetic acid. It may be such that the final bleached product produced by the calcium hydroxide conforms to the descriptions and speci- neutralization of acetic acid.
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(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), p. 44, 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)(2), 2101 Constitution Ave. NW., Wash- the ingredient is used in food only ington, DC 20418, or available for in- within the following specific limita- spection at the Office of the Federal tions: Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Maximum level of (c) The ingredient is used as a firm- Category of food use in Functional use ing agent as defined in § 170.3(o)(10) of food (as served) this chapter; pH control agent as de- (percent) fined in § 170.3(o)(23) of this chapter; processing aid as defined in § 170.3(o)(24) Baked goods, 0.002 Stabilizer, thickener, ¤ 170.3(n)(1) of this ¤ 170.3(o)(28) of this of this chapter; sequestrant as defined chapter. chapter. in § 170.3(o)(26) of this chapter; sta- Alcoholic beverages, 0.4 Do. bilizer and thickener as defined in ¤ 170.3(n)(2) of this § 170.3(o)(28) of this chapter; and chapter. Confections and 0.4 Do. texturizer as defined in § 170.3(o)(32) of frostings, this chapter. ¤ 170.3(n)(9) of this (d) The ingredient is used in food at chapter. levels not to exceed current good man- Egg products, 0.6 Do. ¤ 170.3(n)(11) of this ufacturing practices in accordance chapter. with § 184.1(b)(1). Current good manu- Fats and oils, 0.5 Do. facturing practices result in a max- ¤ 170.3(n)(12) of this imum level, as served, of 0.2 percent for chapter. Gelatins, puddings, 0.25 Do. baked goods as defined in § 170.3(n)(1) of ¤ 170.3(n)(22) of this this chapter; 0.02 percent for cheese as chapter. defined in § 170.3(n)(5) of this chapter; Gravies and sauces, 0.4 Do. 0.2 percent for gelatins, puddings, and ¤ 170.3(n)(24) of this chapter. fillings as defined in § 170.3(n)(22) of Jams and jellies, 0.5 Do. this chapter; 0.15 percent for sweet ¤ 170.3(n)(28) of this sauces, toppings, and syrups as defined chapter. in § 170.3(n)(43) of this chapter; and Sweet sauces, 0.5 Do. ¤ 170.3(n)(43) of this 0.0001 percent for all other food cat- chapter. egories. All other food cat- 0.3 Do. (e) Prior sanctions for this ingredient egories. different from the uses established in this section or in part 181 of this chap- (d) Prior sanctions for calcium algi- ter do not exist or have been waived. nate different from the uses established in this section do not exist or have [47 FR 27807, June 25, 1982] been waived. § 184.1187 Calcium alginate. [47 FR 29951, July 9, 1982] (a) Calcium alginate (CAS Reg. No. § 184.1191 Calcium carbonate. 9005–35–0) is the calcium salt of alginic acid, a natural polyuronide constituent (a) Calcium carbonate (CaCO3, CAS of certain brown algae. Calcium algi- Reg. No. 471–34–1) is prepared by three nate is prepared by the neutralization common methods of manufacture: of purified alginic acid with appro- (1) As a byproduct in the ‘‘Lime soda priate pH control agents, or from so- process’’; dium alginate by metathesis with ap- (2) By precipitation of calcium car- propriate calcium salts. bonate from calcium hydroxide in the (b) The ingredient meets the speci- ‘‘Carbonation process’’; or fications of the Food Chemicals Codex, (3) By precipitation of calcium car- 3d Ed. (1981), p. 45, which is incor- bonate from calcium chloride in the porated by reference. Copies are avail- ‘‘Calcium chloride process’’. able from the National Academy Press, (b) The ingredient meets the speci- 2101 Constitution Ave. NW., Wash- fications of the Food Chemicals Codex,
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3d Ed. (1981), p. 46, which is incor- synergist as defined in § 170.3(o)(31) of porated by reference. Copies are avail- this chapter; and texturizer as defined able from the National Academy Press, in § 170.3(o)(32) of this chapter. 2101 Constitution Ave. NW., Wash- (d) The ingredient is used in foods at ington, DC 20418, or available for in- levels not to exceed current good man- spection at the Office of the Federal ufacturing practices in accordance Register, 800 North Capitol Street, with § 184.1(b)(1). Current good manu- NW., suite 700, Washington, DC 20408. facturing practices result in a max- (c) In accordance with § 184.1(b)(1), imum level, as served, of 0.3 percent for the ingredient is used in food with no baked goods as defined in § 170.3(n)(1) of limitation other than current good this chapter and for dairy product manufacturing practice. analogs as defined in § 170.3(n)(10) of (d) Prior sanctions for this ingredient this chapter; 0.22 percent for non- different from the uses established in alcoholic beverages and beverage bases this section, or different from that set as defined in § 170.3(n)(3) of this chap- forth in part 181 of this chapter, do not ter; 0.2 percent for cheese as defined in exist or have been waived. § 170.3(n)(5) of this chapter and for proc- essed fruit and fruit juices as defined in [48 FR 52441, Nov. 18, 1983] § 170.3(n)(35) of this chapter; 0.32 per- § 184.1193 Calcium chloride. cent for coffee and tea as defined in § 170.3(n)(7) of this chapter; 0.4 percent (a) Calcium chloride (CaCl ·2H O, 2 2 for condiments and relishes as defined CAS Reg. No. 10035–04–8) or anhydrous in § 170.3(n)(8) of this chapter; 0.2 per- calcium chloride (CaCl CAS Reg. No. 2, cent for gravies and sauces as defined 10043–52–4) may be commercially ob- in § 170.3(n)(24) of this chapter; 0.1 per- tained as a byproduct in the ammonia- cent for commercial jams and jellies as soda (Solvay) process and as a joint defined in § 170.3(n)(28) of this chapter; product from natural salt brines, or it 0.25 percent for meat products as de- may be prepared by substitution reac- fined in § 170.3(n)(29) of this chapter; 2.0 tions with other calcium and chloride percent for plant protein products as salts. 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. 47, 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 Register, 800 North Capitol Street, waived. NW., suite 700, Washington, DC 20408. [47 FR 27808, June 25, 1982, as amended at 61 (c) The ingredient is used as an FR 14247, Apr. 1, 1996] anticaking agent as defined in § 170.3(o)(1) of this chapter; anti- § 184.1195 Calcium citrate. microbial agent as defined in (a) Calcium citrate § 170.3(o)(2) of this chapter; curing or (Ca3(C6H5O7)2·4H2O, CAS Reg. No. 813– pickling agent as defined in § 170.3(o)(5) 0994–095) is the calcium salt of citric of this chapter; firming agent as de- acid. It is prepared by neutralizing cit- fined in § 170.3(o)(10) of this chapter; ric acid with calcium hydroxide or cal- flavor enhancer as defined in cium carbonate. It occurs as a fine § 170.3(o)(11) of this chapter; humectant white, odorless powder and usually as defined in § 170.3(o)(16) of this chap- contains four moles of water per mole ter; nutrient supplement as defined in of calcium citrate. § 170.3(o)(20) of this chapter; pH control (b) The ingredient meets the speci- agent as defined in § 170.3(o)(23) of this fications of the Food Chemicals Codex, chapter; processing aid as defined in 3d ed. (1981), pp. 49 and 50, which is in- § 170.3(o)(24) of this chapter; stabilizer corporated by reference in accordance and thickener as defined in § 170.3(o)(28) with 5 U.S.C. 552(a) and 1 CFR part 51. of this chapter; surface-active agent as Copies are available from the National defined in § 170.3(o)(29) of this chapter; Academy Press, 2101 Constitution Ave.
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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), 200 C St. SW., Wash- in § 170.3(n)(42) of this chapter. ington, DC 20204, or may be examined (e) Prior sanctions for this ingredient at the Office of the Federal Register, different from the uses established in 800 North Capitol St. NW., suite 700, this section do not exist or have been Washington, DC. waived. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no [47 FR 27808, June 25, 1982] limitation other than current good § 184.1201 Calcium glycerophosphate. manufacturing practice. Calcium cit- rate may also be used in infant formula (a) Calcium glycerophosphate in accordance with section 412(g) of the (C3H7CaO6P, CAS Reg. No. 27214–00–2) is Federal Food, Drug, and Cosmetic Act a fine, white, odorless, almost taste- (the act) or with regulations promul- less, slightly hygroscopic powder. It is gated under section 412(a)(2) of the act. 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 β- waived. , and D-, and L-α-glycerophosphate. (b) The ingredient meets the speci- [59 FR 63896, Dec. 12, 1994] fications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), pp. 51–52, which is § 184.1199 Calcium gluconate. incorporated by reference in accord- (a) Calcium gluconate ance with 5 U.S.C. 552(a) and 1 CFR ([CH2OH(CHOH)4COO]2Ca, CAS Reg. No. part 51. Copies may be obtained from 299–28–5) is the calcium salt of gluconic the National Academy Press, 2101 Con- acid which may be produced by neu- stitution Ave. NW., Washington, DC tralization of gluconic acid with lime 20418, or may be examined at the Office or calcium carbonate. of the Federal Register, 800 North Cap- (b) The ingredient meets the speci- itol Street, NW., suite 700, Washington, fications of the Food Chemicals Codex, DC. 3d Ed. (1981), p. 51, which is incor- (c) In accordance with § 184.1(b)(1), porated by reference. Copies are avail- the ingredient is used in food with no able from the National Academy Press, limitation other than current good 2101 Constitution Ave. 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 20408. the following current good manufac- (c) The ingredient is used as a firm- turing practice conditions of use: ing agent as defined in § 170.3(o)(10) of (1) The ingredient is used as a nutri- this chapter; formulation aid as defined ent supplement as defined in in § 170.3(o)(14) of this chapter; § 170.3(o)(20) of this chapter. sequestrant as defined in § 170.3(o)(26) of (2) The ingredient is used in gelatins, this chapter; stabilizer or thickener as puddings, and fillings as defined in defined in § 170.3(o)(28) of this chapter; § 170.3(n)(22) of this chapter. and texturizer as defined in § 170.3(o)(32) (d) Prior sanctions for this ingredient of this chapter. different from the uses established in (d) The ingredient is used in foods at this section or different from that as levels not to exceed current good man- set forth in part 181 of this chapter, do ufacturing practices in accordance not exist or have been waived. with § 184.1(b)(1). Current good manu- facturing practices result in a max- [57 FR 10813, Mar. 31, 1992] imum level, as served, of 1.75 percent for baked goods as defined in § 184.1205 Calcium hydroxide. § 170.3(n)(1) of this chapter; 0.4 percent (a) Calcium hydroxide (Ca(OH)2, CAS for dairy product analogs as defined in Reg. No. 1305–62–0) is also known as § 170.3(n)(10) of this chapter; 4.5 percent slaked lime or calcium hydrate. It is for gelatins and puddings as defined in produced by the hydration of lime.
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(b) The ingredient meets the speci- acid with calcium carbonate or cal- fications of the Food Chemicals Codex, cium hydroxide. 3d Ed. (1981), p. 52, 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. 53, 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 Avenue 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)(1), Register, 800 North Capitol Street, the ingredient is used in food with no NW., suite 700, Washington, DC 20408. limitation other than current good (c) In accordance with § 184.1(b)(1), manufacturing 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 [49 FR 26714, June 29, 1984] the following current good manufac- turing practice conditions of use: § 184.1206 Calcium iodate. (1) The ingredient is used as a firm- ing agent as defined in § 170.3(o)(10) of (a) Calcium iodate [Ca(IO3)2·H2O, CAS Reg. No. 7789–80–2], also referred to as this chapter; a flavor enhancer as de- lautarite, does not occur naturally but fined in § 170.3(o)(11) of this chapter; a can be prepared by passing chlorine flavoring agent or adjuvant as defined in § 170.3(o)(12) of this chapter; a leav- into a hot solution of lime (CaCO3) in which iodine has been dissolved. ening agent as defined in § 170.3(o)(17) of (b) The ingredient meets the speci- this chapter; a nutrient supplement as fications of the ‘‘Food Chemicals defined in § 170.3(o)(20) of this chapter; and a stabilizer and thickener as de- Codex,’’ 3d Ed. (1981), p. 53, which is in- fined in § 170.3(o)(28) of this chapter. corporated by reference. Copies may be (2) The ingredient is used in food, ex- obtained from the National Academy cept in infant foods and infant for- Press, 2101 Constitution Ave. NW., mulas, at levels not to exceed current Washington, DC 20418, or may be exam- good manufacturing practice. ined at the Office of the Federal Reg- (d) Prior sanctions for this ingredient ister, 800 North Capitol Street, NW., different from the uses established in suite 700, Washington, DC 20408. this section do not exist or have been (c) The ingredient is used as a dough waived. strengthener as defined in § 170.3(o)(6) of this chapter. [49 FR 35367, Sept. 7, 1984] (d) The ingredient is used in the man- § 184.1210 Calcium oxide. ufacture of bread in accordance with § 184.1(b)(2) of this chapter in an (a) Calcium oxide (CaO, CAS Reg. No. amount not to exceed 0.0075 percent 1305–78–8) is also known as lime, quick based on the weight of the flour. lime, burnt lime, or calx. It is produced (e) Prior sanctions for this ingredient from calcium carbonate, limestone, or different from the uses established in oyster shells by calcination at tem- this section do not exist or have been peratures of 1,700–2,450 °F. waived. (b) The ingredient meets the speci- fications of the Food Chemicals Codex, [43 FR 11699, Mar. 21, 1978, as amended at 49 3d Ed. (1981), p. 55, which is incor- FR 5611, Feb. 14, 1984] porated by reference. Copies are avail- able from the National Academy Press, § 184.1207 Calcium lactate. 2101 Constitution Ave. NW., Wash- (a) Calcium lactate (C6H10CaO6.xH2O, ington, DC 20418, or available for in- where x is any integer up to 5, CAS spection at the Office of the Federal Reg. No. 814–80–2) is prepared commer- Register, 800 North Capitol Street, cially by the neutralization of lactic NW., suite 700, Washington, DC 20408.
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(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 [48 FR 51908, Nov. 15, 1983] manufacturing practice. (d) Prior sanctions for this ingredient § 184.1221 Calcium propionate. different from the uses established in (a) Calcium propionate (C6H10CaO4, this section do not exist or have been CAS Reg. No. 4075–81–4) is the calcium waived. salt of propionic acid. It occurs as [49 FR 26714, June 29, 1984] white crystals or a crystalline solid, possessing not more than a faint odor § 184.1212 Calcium pantothenate. of propionic acid. It is prepared by neu- tralizing propionic acid with calcium (a) Calcium pantothenate hydroxide. ((C H NO ) Ca, CAS Reg. No. of the 9 16 5 2 D- (b) The ingredient meets the speci- isomer, 137–08–6) is a salt of panto- fications of the Food Chemicals Codex, thenic acid, one of the vitamins of the 3d Ed. (1981), p. 60, which is incor- B complex. Only the D-isomer of panto- porated by reference. Copies are avail- thenic acid has vitamin activity, al- able from the National Academy Press, though both the D-isomer and the DL- 2101 Constitution Ave. NW., Wash- racemic mixture of calcium panto- ington, DC 20418, or available for in- thenate are used in food. Commercial spection at the Office of the Federal calcium pantothenate is prepared syn- Register, 800 North Capitol Street, thetically from isobutyraldehyde and NW., suite 700, Washington, DC 20408. formaldehyde via 1,1-dimethyl-2-hy- (c) In accordance with § 184.1(b)(1), droxy-propionaldehyde and the ingredient is used in food with no pantolactone. limitation other than current good (b) Calcium pantothenate meets the manufacturing practice. The affirma- specifications of the Food Chemicals tion of this ingredient as generally rec- Codex, 3d Ed. (1981), p. 56, which is in- ognized as safe (GRAS) as a direct corporated by reference. Copies are human food ingredient is based upon available from the National Academy the following current good manufac- Press, 2101 Constitution Ave. NW., turing practice conditions of use: Washington, DC 20418, or available for (1) The ingredient is used as an anti- inspection at the Office of the Federal microbial agent as defined in Register, 800 North Capitol Street, § 170.3(o)(2) of this chapter. NW., suite 700, Washington, DC 20408. (2) The ingredient is used in the fol- (c) In accordance with § 184.1(b)(1), lowing foods at levels not to exceed the ingredient is used in food with no current good manufacturing practice: limitation other than current good baked goods as defined in § 170.3(n)(1) of manufacturing practice. The affirma- this chapter; cheeses as defined in tion of this ingredient as generally rec- § 170.3(n)(5) of this chapter; confections ognized as safe (GRAS) as a direct and frostings as defined in § 170.3(n)(9) human food ingredient is based upon of this chapter; gelatins, puddings, and the following current good manufac- fillings as defined in § 170.3(n)(22) of turing practice conditions of use: this chapter; and jams and jellies as de- (1) The ingredient is used as a nutri- fined in § 170.3(n)(28) of this chapter. ent supplement as defined in (d) Prior sanctions for this ingredient § 170.3(o)(20) of this chapter. different from the uses established in (2) The ingredient is used in foods at this section do not exist or have been levels not to exceed current good man- waived. ufacturing practice. Calcium panto- [49 FR 13141, Apr. 3, 1984] thenate may be used in infant formula in accordance with section 412(g) of the § 184.1229 Calcium stearate.
Federal Food, Drug, and Cosmetic Act (a) Calcium stearate (Ca(C17H35COO)2, (the act) or with regulations promul- CAS Reg. No. 1529–23–0) is the calcium gated under section 412(a)(2) of the Act. salt of stearic acid derived from edible (d) Prior sanctions for this ingredient sources. It is prepared as a white pre- different from the uses established in cipitate by mixing calcium chloride
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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 3d Ed. (1981), p. 64, which is incor- § 170.3(o)(4) of this chapter, dough porated by reference, and the require- strengthener as defined in § 170.3(o)(6) ments of § 172.860(b)(2) of this chapter. of this chapter, drying agent as defined Copies of the Food Chemicals Codex in § 170.3(o)(7) of this chapter, firming are available from the National Acad- agent as defined in § 170.3(o)(10) of this emy Press, 2101 Constitution Ave. NW., chapter, flour treating agent as defined Washington, DC 20418, or available for in § 170.3(o)(13) of this chapter, formula- inspection at the Office of the Federal tion aid as defined in § 170.3(o)(14) of Register, 800 North Capitol Street, this chapter, leavening agent as de- NW., suite 700, Washington, DC 20408. 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 limitation 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 the following current good manufac- § 170.3(o)(31) of this chapter, and turing practice conditions of use: texturizer as defined in § 170.3(o)(32) of (1) The ingredient is used as a fla- this chapter. voring agent and adjuvant as defined in (d) The ingredient is used in food at § 170.3(o)(12) of this chapter; a lubricant levels not to exceed good manufac- and release agent as defined in turing practice in accordance with § 170.3(o)(18) of this chapter; and a sta- § 184.1(b)(1). Current good manufac- bilizer and thickener as defined in turing practice results in a maximum § 170.3(o)(28) of this chapter. level, as served, of 1.3 percent for baked (2) The ingredient is used in foods at goods as defined in § 170.3(n)(1) of this levels not to exceed current good man- chapter, 3.0 percent for confections and ufacturing practice. frostings as defined in § 170.3(n)(9) of (d) Prior sanctions for this ingredient this chapter, 0.5 percent for frozen different from the uses established in dairy desserts and mixes as defined in this section do not exist or have been § 170.3(n)(20) of this chapter, 0.4 percent waived. for gelatins and puddings as defined in [48 FR 52445, Nov. 18, 1983] § 170.3(n)(22) of this chapter, 0.5 percent for grain products and pastas as de- § 184.1230 Calcium sulfate. fined in § 170.3(n)(23) of this chapter, (a) Calcium sulfate (CaSO CAS Reg. 0.35 percent for processed vegetables as 4, defined in § 170.3(n)(36) of this chapter, No. 7778–18–9 or CaSO4·2H2O, CAS Reg. No. 10101–41–4), also known as plaster of and 0.07 percent or less for all other Paris, anhydrite, and gypsum, occurs food categories. naturally and exists as a fine, white to (e) Prior sanctions for this ingredient slightly yellow-white odorless powder. different from the uses established in The anhydrous form is prepared by this section do not exist or have been complete dehydration of gypsum, below waived. 300 °C, in an electric oven. [45 FR 6086, Jan. 25, 1980; 45 FR 26319, Apr. 18, (b) The ingredient meets the speci- 1980, as amended at 49 FR 5611, Feb. 14, 1984] fications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), p. 66, which is in- § 184.1240 Carbon dioxide. corporated by reference. Copies may be (a) Carbon dioxide (empirical formula obtained from the National Academy CO2, CAS Reg. No. 124–38–9) occurs as a Press, 2101 Constitution Ave. NW., colorless, odorless, noncombustible gas Washington, DC 20418, or may be exam- at normal temperatures and pressures. ined at the Office of the Federal Reg- The solid form, dry ice, sublimes under ister, 800 North Capitol Street, NW., atmospheric pressure at a temperature suite 700, Washington, DC 20408. of ¥78.5 °C. Carbon dioxide is prepared
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as a byproduct of the manufacture of (c) In accordance with § 184.1(b)(1), lime during the ‘‘burning’’ of lime- the ingredient is used in food with no stone, from the combustion of carbo- limitation other than current good naceous material, from fermentation manufacturing practice. The affirma- processes, and from gases found in cer- tion of this ingredient as generally rec- tain natural springs and wells. ognized as safe (GRAS) as a direct (b) The Food and Drug Administra- human food ingredient is based upon tion is developing food-grade specifica- the following current good manufac- tions for carbon dioxide in cooperation turing practice conditions of use: with the National Academy of (1) The ingredient is used as a nutri- Sciences. In the interim, the ingredient ent supplement as defined in must be of purity suitable for its in- § 170.3(o)(20) of this chapter. tended use. (2) The ingredient is used in the fol- (c) In accordance with § 184.1(b)(1), lowing foods at levels not to exceed the ingredient is used in food with no current good manufacturing practice: limitations other than current good dairy product analogs as defined in manufacturing practice. The affirma- § 170.3(n)(10) of this chapter; fats and tion of this ingredient as generally rec- oils as defined in § 170.3(n)(12) of this ognized as safe (GRAS) as a direct chapter; and processed fruits and fruit human food ingredient is based upon juices as defined in § 170.3(n)(35) of this the following current good manufac- chapter. Beta-carotene may be used in turing practice conditions of use: infant formula as a source of vitamin A (1) The ingredient is used as a leav- in accordance with section 412(g) of the ening agent as defined in § 170.3(o)(17) of Federal Food, Drug, and Cosmetic Act this chapter; a processing aid as de- or with regulations promulgated under fined in § 170.3(o)(24) of this chapter; section 412(g) of the act. and a propellant, aerating agent, and (d) Prior sanctions for this ingredient gas as defined in § 170.3(o)(25) of this different from the uses established in chapter. this section do not exist or have been (2) The ingredient is used in food at waived. levels not to exceed current good man- ufacturing practice. [52 FR 25211, July 6, 1987] (d) Prior sanctions for this ingredient § 184.1250 Cellulase enzyme prepara- different from the uses established in tion derived from Trichoderma this section do not exist or have been longibrachiatum. waived. (a) Cellulase enzyme preparation is [48 FR 57270, Dec. 29, 1983] derived from a nonpathogenic, nontoxicogenic strain of Trichoderma § 184.1245 Beta-carotene. longibrachiatum (formerly T. reesei). The (a) Beta-carotene (CAS Reg. No. 7235– enzyme, cellulase, catalyzes the 40–7) has the molecular formula C40H56. endohydrolysis of 1,4-beta-glycosidic It is synthesized by saponification of linkages in cellulose. It is obtained vitamin A acetate. The resulting alco- from the culture filtrate resulting from hol is either reacted to form vitamin A a pure culture fermentation process. Wittig reagent or oxidized to vitamin A (b) The ingredient meets the general aldehyde. Vitamin A Wittig reagent and additional requirements for en- and vitamin A aldehyde are reacted to- zyme preparations in the monograph gether to form beta-carotene. specifications on enzyme preparations (b) The ingredient meets the speci- in the ‘‘Food Chemicals Codex,’’ 4th ed. fications of the Food Chemicals Codex, (1996), pp. 129 to 134, which is incor- 3d Ed. (1981), p. 73, which is incor- porated by reference in accordance porated by reference. Copies are avail- with 5 U.S.C. 552(a) and 1 CFR part 51. able from the National Academy Press, Copies are available from the National 2101 Constitution Ave. NW., Academy Press, 2101 Constitution Ave. Washingtion, DC 20418, or available for NW., Box 285, Washington, DC 20055 inspection at the Office of the Federal (Internet ‘‘http://www.nap.edu’’), or Register, 800 North Capitol Street, may be examined at the Center for NW., suite 700, Washington, DC 20408. Food Safety and Applied Nutrition’s
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Library, 200 C St. SW., rm. 3321, Wash- (1) The assay for phenols, as eugenol, ington, DC, or at the Office of the Fed- by the ‘‘Food Chemicals Codex’’ test, eral Register, 800 North Capitol St. 4th ed. (pp. 104–105), or the volatile oils NW., suite 700, Washington, DC. content by the ‘‘Food Chemicals (c) In accordance with § 184.1(b)(1), Codex’’ test, 4th ed. (pp. 104–105) should the ingredient is used in food with no conform to the representation of the limitation other than current good vendor; manufacturing practice. The affirma- (2) Optical rotation of the volatile oil tion of this ingredient as generally rec- between ¥2° and 0°; ognized as safe (GRAS) as a direct (3) Refractive index of the volatile oil human food ingredient is based upon between 1.527 and 1.538 at 20 °C; the following current good manufac- (4) Specific gravity of the volatile oil turing practice conditions of use: between 1.036 and 1.060; and (1) The ingredient is used in food as (5) Residual solvent free, except those an enzyme as defined in § 170.3(o)(9) of solvents that are GRAS or within tol- this chapter for the breakdown of cel- erance levels as specified in part 173, lulose. subpart C, of this chapter. (2) The ingredient is used in food at (c) Clove and its derivatives are used levels not to exceed current good man- as flavoring agents and adjuvants as ufacturing practice. defined in § 170.3(0)(12) of this chapter. [64 FR 28361, May 26, 1999] (d) The ingredients are used in food at levels not to exceed good manufac- § 184.1257 Clove and its derivatives. turing practice in accordance with (a) Cloves are the dried unopened § 184.1(b)(1). flower buds and calyx tubes, harvested (e) Prior sanctions for these ingredi- before the flowers have opened, of the ents different from the uses established clove tree Eugenia caryophyllata in this section do not exist or have Thunberg, native to tropical Asia. been waived. Their derivatives include essential oils (cloves, CAS Reg. No. 8000–34–8; buds; [44 FR 3964, Jan 19, 1979, as amended at 47 FR leaves, CAS Reg. No. 8015–97–2; stems, 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, 1984; 64 FR 1759, Jan. 12, 1999] CAS Reg. No. 8015–98–3; and eugenol, CAS Reg. No. 97–53–0), oleoresins, and § 184.1259 Cocoa butter substitute. natural extractives obtained from clove buds, leaves, and stems. (a) The common or usual name for (b) Clove bud oil, clove leaf oil, clove the triglyceride 1-palmitoyl-2-oleoyl-3- stem oil, and eugenol meet the speci- stearin is ‘‘cocoa butter substitute pri- fications of the ‘‘Food Chemicals marily from palm oil.’’ The common or Codex,’’ 4th ed. (1996), pp. 104–105, which usual name for the triglyceride 1-3- is incorporated by reference in accord- distearoyl-2-olein is ‘‘cocoa butter sub- ance with 5 U.S.C. 552(a) and 1 CFR stitute primarily from high-oleic saf- part 51. Copies are available from the flower or sunflower oil.’’ National Academy Press, Box 285, 2101 (1) The ingredient 1-palmitoyl-2-ole- Constitution Ave. NW., Washington, oyl-3-stearin is manufactured by: DC 20055 (Internet address ‘‘http:// (i) Directed esterification of fully www.nap.edu’’), or may be examined at saturated 1,3-diglycerides (derived from the Center for Food Safety and Applied palm oil) with the anhydride of food- Nutrition’s Library, Food and Drug Ad- grade oleic acid in the presence of the ministration, 200 C St. SW., rm. 3321, catalyst trifluoromethane sulfonic acid Washington, DC, or at the Office of the (§ 173.395 of this chapter), or Federal Register, 800 North Capitol St. (ii) By interesterification of partially NW., suite 700, Washington, DC. As de- saturated 1,2,3-triglycerides (derived termined by analytical methods in the from palm oil) with ethyl stearate in ‘‘Food Chemicals Codex,’’ clove oleo- the presence of a suitable lipase en- resin or other natural extractives zyme preparation that is either gen- (other than clove oils) meet the ‘‘Food erally recognized as safe (GRAS) or has Chemicals Codex’’ specifications for food additive approval for such use. clove (clove bud) oil and the following (2) The ingredient 1-3-distearoyl-2- modifications: olein is manufactured by
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interesterification of partially unsatu- residuals in accordance with good man- rated 1,2,3-triglycerides (derived from ufacturing practice. high-oleic safflower or sunflower oil) (7) Residual methanol—5 parts per with ethyl stearate or stearic acid in million maximum. the presence of a suitable lipase en- (8) Residual fatty acid ethyl esters— zyme preparation that is either GRAS not more than 20 parts per million as or has food additive approval for such determined by a ‘‘Modification of use. Japan Institute of Oils and Fats: Anal- (b) The ingredient meets the fol- ysis Method of Residual Ethyl Esters of lowing specifications: Fatty Acids’’ issued by the Fuji Oil (1) Over 90 percent triglycerides, not Co., which is incorporated by reference. more than 7 percent diglycerides, not Copies are available from the Division more than 1 percent monoglycerides, of Food and Color Additives, Center for and not more than 1 percent free fatty Food Safety and Applied Nutrition acids. (HFS–200), Food and Drug Administra- (2) Total glycerides—98 percent min- tion, 200 C St. SW., Washington, DC imum. 20204, or available for inspection at the Office of the Federal Register, 800 (3) Heavy metals (as lead), not more North Capitol Street, NW., suite 700, than 10 milligrams per kilogram, as de- Washington, DC 20408. termined by the Heavy Metals Test of (9) Hexane—not more than 5 parts per the ‘‘Food Chemicals Codex,’’ 4th ed. million as determined by the method of (1996), pp. 760–761, which is incorporated Dupuy et al., ‘‘Rapid Quantitative De- by reference in accordance with 5 termination of Residual Hexane in Oils U.S.C. 552(a) and 1 CFR part 51. Copies by Direct Gas Chromatography,’’ pub- are available from the National Acad- lished in the ‘‘Journal of the American emy Press, Box 285, 2101 Constitution Oil Chemists’ Society,’’ Vol. 52, p. 118– Ave. NW., Washington, DC 20055 (Inter- 120, 1975, which is incorporated by ref- net address ‘‘http://www.nap.edu’’), or erence. Copies are available from the may be examined at the Center for Division of Food and Color Additives, Food Safety and Applied Nutrition’s Center for Food Safety and Applied Nu- Library, Food and Drug Administra- trition (HFS–200), Food and Drug Ad- tion, 200 C St. SW., rm. 3321, Wash- ministration, 200 C St. SW., Wash- ington, DC, or at the Office of the Fed- ington, DC 20204, or available for in- eral Register, 800 North Capitol St. spection at the Office of the Federal NW., suite 700, Washington, DC. Register, 800 North Capitol Street, (4) Color—clear, bright, and free from NW., suite 700, Washington, DC 20408. suspended matter. (c) In accordance with § 184.1(b)(1), (5) Odor and taste—free from foreign the ingredient is used in the following and rancid odor and taste. food categories at levels not to exceed (6) Residual catalyst (‘‘Official Meth- current good manufacturing practice: ods of Analysis of the Association of Confections and frostings as defined in Official Analytical Chemists,’’ 13th Ed. § 170.3(n)(9) of this chapter; coatings of (1980), sections 25.049–25.055, which is soft candy as defined in §170.3(n)(38) of incorporated by reference), residual this chapter; and sweet sauces and top- fluorine; limit of detection 0.2 part per pings as defined in §170.3(n)(43) of this million F; multiply fluoride result by chapter; except that the ingredient 2.63 to convert to residual catalyst. may not be used in a standardized food Copies of the material incorporated by unless permitted by the standard of reference may be obtained from the As- identity. sociation of Official Analytical Chem- (d) The ingredient is used in food in ists, P.O. Box 540, Benjamin Franklin accordance with § 184.1(b)(1) at levels Station, Washington, DC 20044, or may not to exceed good manufacturing be examined at the Office of the Fed- practice. eral Register, 800 North Capitol Street, [43 FR 54239, Nov. 11, 1978, as amended at 47 NW., suite 700, Washington, DC 20408. FR 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, The ingredient shall be washed three 1984; 49 FR 22799, June 1, 1984; 52 FR 47920, times in batches with 0.5 percent so- Dec. 17, 1987; 52 FR 48905, Dec. 28, 1987; 61 FR dium bicarbonate to remove catalyst 36290, July 10, 1996; 64 FR 1760, Jan. 12, 1999]
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§ 184.1260 Copper gluconate. (b) FDA is developing food-grade (a) Copper gluconate (cupric gluco- specifications for copper sulfate in co- operation with the National Academy nate (CH2OH(CHOH)4COO)2Cu, CAS Reg. No. 527–09–3) is a substance that of Sciences. In the interim, this ingre- occurs as light blue to bluish-green, dient must be of a purity suitable for odorless crystals, or as a fine, light its intended use. blue powder. It is prepared by the reac- (c) In accordance with § 184.1(b)(1), tion of gluconic acid solutions with cu- the ingredient is used in food with no pric oxide or basic cupric carbonate. 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. 90, 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 nutri- spection at the Office of the Federal ent supplement as defined in Register, 800 North Capitol Street, § 170.3(o)(20) of this chapter and as a NW., suite 700, Washington, DC. 20408. processing aid as defined in § 170.3(o)(24) (c) In accordance with § 184.1(b)(1), of this chapter. the ingredient is used in food with no (2) The ingredient is used in food at limitation other than current good manufacturing practice. The affirma- levels not to exceed current good man- tion of this ingredient as generally rec- ufacturing practice. Copper sulfate ognized as safe (GRAS) as a direct may be used in infant formula in ac- human food ingredient is based upon cordance with section 412(g) of the Fed- the following current good manufac- eral Food, Drug, and Cosmetic Act (the turing practice conditions of use: Act) or with regulations promulgated (1) The ingredient is used as a nutri- under section 412(a)(2) of the Act. ent supplement as defined in (d) Prior sanctions for this ingredient § 170.3(o)(20) of this chapter and as a different from the uses established in synergist as defined in § 170.3(o)(31) of this section do not exist or have been this chapter. waived. (2) The ingredient is used in food at levels not to exceed current good man- [49 FR 24119, June 12, 1984] ufacturing practice. Copper gluconate § 184.1262 Corn silk and corn silk ex- may be used in infant formula in ac- tract. cordance with section 412(g) of the Fed- eral Food, Drug, and Cosmetic Act (the (a) Corn silk is the fresh styles and Act) or with regulations promulgated stigmas of Zea mays L. collected when under section 412(a)(2) of the Act. the corn is in milk. The filaments are (d) Prior sanctions for this ingredient extracted with dilute ethanol to different from the uses established in produce corn silk extract. The extract this section do not exist or have been may be concentrated at a temperature waived. not exceeding 60 °C. [49 FR 24119, June 12, 1984] (b) The Food and Drug Administra- tion, in cooperation with the National § 184.1261 Copper sulfate. Academy of Sciences, is developing (a) Copper sulfate (cupric sulfate, food-grade specifications for corn silk and corn silk extract. In the interim, CuSO4·5H2O, CAS Reg. No. 7758–98–7) usually is used in the pentahydrate this ingredient must be of a suitable form. This form occurs as large, deep purity for its intended use. blue or ultramarine, triclinic crystals; (c) In accordance with § 184.1(b)(2), as blue granules, or as a light blue pow- the ingredients are used in food only der. The ingredient is prepared by the within the following specific limita- reaction of sulfuric acid with cupric tions: oxide or with copper metal.
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Maximum (b) The ingredient meets the appro- level of Category of food use in Functional use priate part of the specification set food (as forth in the ‘‘Food Chemicals Codex,’’ 1 served) 3d Ed. (1981), pp. 92–93, which is incor- Baked goods and bak- 30 Flavoring agent, porated by reference. Copies may be ing mixes, ¤ 170.3(o)(12) of this obtained from the National Academy ¤ 170.3(n)(1) of this chapter. chapter. Press, 2101 Constitution Ave. NW., Nonalcoholic bev- 20 Do. Washington, DC 20418, or may be exam- erages, ¤ 170.3(n)(3) ined at the Office of the Federal Reg- of this chapter. ister, 800 North Capitol Street, NW., Frozen dairy desserts, 10 Do. ¤ 170.3(n)(20) of this suite 700, Washington, DC 20408. chapter. (c) The ingredient is used to supply Soft candy, 20 Do. up to 0.009 part of total L-cysteine per ¤ 170.3(n)(38) of this chapter. 100 parts of flour in dough as a dough All other food cat- 4 Do. strengthener as defined in § 170.3(o)(6) egories. of this chapter in yeast-leavened baked 1 Parts per million. goods and baking mixes as defined in (d) Prior sanctions for this ingredient § 170.3(n)(1) of this chapter. different from the uses established in (d) This regulation is issued prior to this section do not exist or have been a general evaluation of use of this in- waived. gredient in order to affirm as GRAS the specific use named. [47 FR 29953, July 9, 1982] [42 FR 14653, Mar. 15, 1977, as amended at 49 § 184.1265 Cuprous iodide. FR 5612, Feb. 14, 1984] (a) Cuprous iodide (copper (I) iodide, § 184.1272 L-Cysteine CuI, CAS Reg. No. 7681–65–4) is a pure monohydrochloride. white crystalline powder. It is prepared by the reaction of copper sulfate with (a) L-Cysteine monohydrochloride is potassium iodide under slightly acidic the chemical L-2-amino-3- conditions. mercaptopropanoic acid (b) FDA is developing food-grade monohydrochloride monohydrate specifications for cuprous iodide in co- (C3H7O2NS HCl H2O). operation with the National Academy (b) The ingredient meets the speci- of Sciences. In the interim, this ingre- fications of the ‘‘Food Chemicals dient must be of a purity suitable for Codex,’’ 3d Ed. (1981), pp. 92–93, which is its intended use. incorporated by reference. Copies may (c) In accordance with § 184.1(b)(2), be obtained from the National Acad- the ingredient is used in food only emy Press, 2101 Constitution Ave. NW., within the following specific limita- Washington, DC 20418, or may be exam- tions: ined at the Office of the Federal Reg- ister, 800 North Capitol Street, NW., Cat- Maximum treatment egory level in food Functional use suite 700, Washington, DC 20408. of food (c) The ingredient is used to supply Table 0.01 percent ...... Source of dietary iodine. up to 0.009 part of total L-cysteine per salt. 100 parts of flour in dough as a dough strengthener as defined in § 170.3(o)(6) (d) Prior sanctions for this ingredient of this chapter in yeast-leavened baked different from the uses established in goods and baking mixes as defined in this section do not exist or have been § 170.3(n)(1) of this chapter. waived. (d) This regulation is issued prior to [49 FR 24119, June 12, 1984] a general evaluation of use of this in- gredient in order to affirm as GRAS § 184.1271 L-Cysteine. the specific use named. (a) L-Cysteine is the chemical L-2- amino-3-mercaptopropanoic acid [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984] (C3H7O2NS).
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§ 184.1277 Dextrin. (b) The ingredient meets the speci- fications of the Food Chemicals Codex, (a) Dextrin ((C6H10O5)n·H2O, CAS Reg. No. 9004–53–9) is an incompletely 3d Ed. (1981), p. 368, which is incor- hydrolyzed starch. It is prepared by dry porated by reference. Copies are avail- heating corn, waxy maize, waxy milo, able from the National Academy Press, potato, arrowroot, wheat, rice, tapioca, 2101 Constitution Ave. NW., Wash- or sago starches, or by dry heating the ington, DC 20418, or available for in- starches after: (1) Treatment with safe spection at the Office of the Federal and suitable alkalis, acids, or pH con- Register, 800 North Capitol Street, trol agents and (2) drying the acid or NW., suite 700, Washington, DC 20408. alkali treated starch. (c) In accordance with § 184.1(b)(1), (b) The ingredient meets the speci- the ingredient is used in food with no fication of the Food Chemicals Codex, limitation other than current good 3d Ed. (1981), p. 96, which is incor- manufacturing practice. The affirma- porated by reference. Copies are avail- tion of this ingredient as generally rec- able from the National Academy Press, ognized as safe (GRAS) as a direct 2101 Constitution Ave. NW., Wash- human food ingredient is based upon ington, DC 20418, or available for in- the following current good manufac- spection at the Office of the Federal turing practice conditions of use: Register, 800 North Capitol Street, (1) The ingredient is used 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 (2) The ingredient is used in food at limitation other than current good levels not to exceed current good man- manufacturing practice. The affirma- ufacturing practice. tion of this ingredient as generally rec- (d) Prior sanctions for this ingredient ognized as safe (GRAS) as a direct different from the uses established in human food ingredient is based upon this section do not exist or have been the following current good manufac- waived. turing practice conditions of use: [48 FR 51907, Nov. 15, 1983] (1) The ingredient is used as a formu- lation aid as defined in § 170.3(o)(14) of § 184.1282 Dill and its derivatives. this chapter; as a processing aid as de- (a) Dill (American or European) is fined in § 170.3(o)(24) of this chapter; as the herb and seeds from Anethum a stabilizer and thickener as defined in graveolens L., and dill (Indian) is the § 170.3(o)(28) of this chapter; and as a herb and seeds from Anethum sowa, surface-finishing agent as defined in D.C. Its derivatives include essential § 170.3(o)(30) of this chapter. oils, oleoresins, and natural extractives (2) The ingredient is used in food at obtained from these sources of dill. levels not to exceed current good man- (b) Dill oils meet the description and ufacturing practice. specifications of the ‘‘Food Chemicals (d) Prior sanctions for this ingredient Codex,’’ 4th ed. (1996), pp. 122–123, which different from the uses established in is incorporated by reference in accord- this section do not exist or have been ance with 5 U.S.C. 552(a) and 1 CFR waived. part 51. Copies are available from the [48 FR 51909, Nov. 15, 1983] National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, § 184.1278 Diacetyl. DC 20055 (Internet address ‘‘http:// (a) Diacetyl (C4H6O2, CAS Reg. No. www.nap.edu’’), or may be examined at 431–03–8) is a clear yellow to yellowish the Center for Food Safety and Applied green liquid with a strong pungent Nutrition’s Library, Food and Drug Ad- odor. It is also known as 2,3- ministration, 200 C St. SW., rm. 3321, butanedione and is chemically syn- Washington, DC, or at the Office of the thesized from methyl ethyl ketone. It Federal Register, 800 North Capitol St. is miscible in water, glycerin, alcohol, NW., suite 700, Washington, DC. and ether, and in very dilute water so- (c) Dill and its derivatives are used as lution, it has a typical buttery odor flavoring agents and adjuvants as de- and flavor. fined in § 170.3(o)(12) of this chapter.
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(d) The ingredients are used in food § 184.1293 Ethyl alcohol. at levels not to exceed good manufac- (a) Ethyl alcohol (ethanol) is the turing practice. chemical C H OH. (e) [Reserved] 2 5 (b) The ingredient meets the speci- (f) Prior sanctions for these ingredi- fications of the ‘‘Food Chemicals ents different from the uses established Codex,’’ 4th ed. (1996), p. 136, which is in this section do not exist or have incorporated by reference in accord- been waived. ance with 5 U.S.C. 552(a) and 1 CFR [42 FR 14653, Mar. 15, 1977, as amended at 42 part 51. Copies are available from the FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, National Academy Press, Box 285, 2101 1984; 64 FR 1760, Jan. 12, 1999] Constitution Ave. NW., Washington, DC 20055 (Internet address ‘‘http:// § 184.1287 Enzyme-modified fats. www.nap.edu’’), or may be examined at (a) Enzyme-modified refined beef fat, the Center for Food Safety and Applied enzyme-modified butterfat, and en- Nutrition’s Library, Food and Drug Ad- zyme-modified steam-rendered chicken ministration, 200 C St. SW., rm. 3321, fat are prepared from refined beef fat; Washington, DC, or at the Office of the butterfat or milkfat; and steam-ren- Federal Register, 800 North Capitol St. dered chicken fat, respectively, with NW., suite 700, Washington, DC. enzymes that are generally recognized (c) The ingredient is used as an anti- as safe (GRAS). Enzyme-modified milk microbial agent as defined in powder may be prepared with GRAS § 170.3(o)(2) of this chapter on pizza enzymes from reconstituted milk pow- crusts prior to final baking at levels der, whole milk, condensed or con- not to exceed 2.0 percent by product centrated whole milk, evaporated weight. milk, or milk powder. The lipolysis is (d) This regulation is issued prior to maintained at a temperature that is general evaluation of use of this ingre- optimal for the action of the enzyme dient in order to affirm as GRAS the until appropriate acid development is specific use named. attained. The enzymes are then inac- tivated. The resulting product is con- [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984; 64 FR 1760, Jan. 12, centrated or dried. 1999] (b) FDA is developing food-grade specifications for these enzyme-modi- § 184.1295 Ethyl formate. fied ingredients in cooperation with (a) Ethyl formate (C H O CAS Reg. the National Academy of Sciences. In 3 6 2, No. 109–94–4) is also referred to as ethyl the interim, the ingredients must be of methanoate. It is an ester of formic purity suitable for their intended use. acid and is prepared by esterification (c) In accordance with § 184.1(b)(1), of formic acid with ethyl alcohol or by the ingredients are used in food with distillation of ethyl acetate and formic no limitation other than current good acid in the presence of concentrated manufacturing practice. The affirma- sulfuric acid. Ethyl formate occurs tion of these ingredients as generally naturally in some plant oils, fruits, and recognized as safe (GRAS) as direct juices but does not occur naturally in human food ingredients is based upon the animal kingdom. the following current good manufac- (b) The ingredient meets the speci- turing practice conditions of use: fications of the ‘‘Food Chemicals (1) The ingredients are used as fla- Codex,’’ 3d Ed. (1981), p. 376, which is in- voring agents and adjuvants as defined corporated by reference. Copies may be in § 170.3(o)(12) of this chapter. obtained from the National Academy (2) The ingredients are used in food Press, 2101 Constitution Ave. NW., at levels not to exceed current good Washington, DC 20418, or may be exam- manufacturing practice. ined at the Office of the Federal Reg- (d) Prior sanctions for these ingredi- ister, 800 North Capitol Street, NW., ents different from the uses established suite 700, Washington, DC 20408. in this section do not exist or have (c) The ingredient is used as a fla- been waived. voring agent and adjuvant as defined in [52 FR 25976, July 10, 1987] § 170.3(o)(12) of this chapter.
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(d) The ingredient is used in food at Washington, DC 20418, or available for levels not to exceed good manufac- inspection at the Office of the Federal turing practice in accordance with Register, 800 North Capitol Street, § 184.1(b)(1). Current good manufac- NW., suite 700, Washington, DC 20408. turing practice results in a maximum (c) In accordance with § 184.1(b)(1), level, as served, of 0.05 percent in baked the ingredients are used in food as nu- goods as defined in § 170.3(n)(1) of this trient supplements as defined in chapter; 0.04 percent in chewing gum as § 170.3(o)(20) of this chapter, with no defined in § 170.3(n)(6), hard candy as limitation other than current good defined in § 170.3(n)(25), and soft candy manufacturing practice. The ingredi- as defined in § 170.3(n)(38) of this chap- ents may also be used in infant formula ter; 0.02 percent in frozen dairy des- in accordance with section 412(g) of the serts as defined in § 170.3(n)(20) of this Federal Food, Drug, and Cosmetic Act chapter; 0.03 percent in gelatins, pud- (the act) (21 U.S.C. 350a(g)) or with reg- dings, and fillings as defined in ulations promulgated under section § 170.3(n)(22) of this chapter; and 0.01 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). percent in all other food categories. (d) Prior sanctions for these ingredi- (e) Prior sanctions for ethyl formate ents different from the uses established different from the uses established in in this section do not exist or have this section do not exist or have been been waived. waived. [53 FR 16864, May 12, 1988] [45 FR 22915, Apr. 4, 1980, as amended at 49 FR 5612, Feb. 14, 1984] § 184.1297 Ferric chloride. § 184.1296 Ferric ammonium citrate. (a) Ferric chloride (iron (III) chlo- (a) Ferric ammonium citrate (iron ride, FeC13, CAS Reg. No. 7705–08–0) (III) ammonium citrate) is prepared by may be prepared from iron and chlorine the reaction of ferric hydroxide with or from ferric oxide and hydrogen chlo- citric acid, followed by treatment with ride. The pure material occurs as ammonium hydroxide, evaporating, hydroscopic, hexagonal, dark crystals. and drying. The resulting product oc- Ferric chloride hexahydrate (iron (III) curs in two forms depending on the chloride hexahydrate, FeC13. 6H20, CAS stoichiometry of the initial reactants. Reg. No. 10025–77–1) is readily formed (1) Ferric ammonium citrate (iron when ferric chloride is exposed to mois- (III) ammonium citrate, CAS Reg. No. ture. 1332–98–5) is a complex salt of undeter- (b) The Food and Drug Administra- mined structure composed of 16.5 to tion is developing food-grade specifica- 18.5 percent iron, approximately 9 per- tions for ferric chloride in cooperation cent ammonia, and 65 percent citric with the National Academy of acid and occurs as reddish brown or Sciences. In the interim, this ingre- garnet red scales or granules or as a dient must be of a purity suitable for brownish-yellowish powder. its intended use. (2) Ferric ammonium citrate (iron (c) In accordance with § 184.1(b)(1) the (III) ammonium citrate, CAS Reg. No. ingredient is used in food as a flavoring 1333–00–2) is a complex salt of undeter- agent as defined in § 170.3(o)(12) of this mined structure composed of 14.5 to 16 chapter, with no limitation other than percent iron, approximately 7.5 percent current good manufacturing practice. ammonia, and 75 percent citric acid (d) Prior sanctions for this ingredient and occurs as thin transparent green different from the uses established in scales, as granules, as a powder, or as this section do not exist or have been transparent green crystals. waived. (b) The ingredients meet the speci- fications of the Food Chemicals Codex, [53 FR 16864, May 12, 1988] 3d Ed. (1981), pp. 116–117 (Ferric ammo- nium citrate, brown) and p. 117 (Ferric § 184.1298 Ferric citrate. ammonium citrate, green), which is in- (a) Ferric citrate (iron (III) citrate, corporated by reference. Copies are C6H5FeO7, CAS Reg. No. 2338–05–8) is available from the National Academy prepared from reaction of citric acid Press, 2101 Constitution Ave. NW., with ferric hydroxide. It is a compound
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of indefinite ratio of citric acid and section 412(a)(2) of the act (21 U.S.C. iron. 350a(a)(2)). (b) The Food and Drug Administra- (d) Prior sanctions for this ingredient tion is developing food-grade specifica- different from the uses established in tions for ferric citrate in cooperation this section do not exist or have been with the National Academy of waived. Sciences. In the interim, this ingre- dient must be of a purity suitable for [53 FR 16865, May 12, 1988] its intended use. (c) In accordance with § 184.1(b)(1), § 184.1304 Ferric pyrophosphate. the ingredient is used in food as a nu- (a) Ferric pyrophosphate (iron (III) trient supplement as defined in pyrophosphate, Fe4(P207)3·xH2O, CAS § 170.3(o)(20) of this chapter, with no Reg. No. 10058–44–3) is a tan or yel- limitation other than current good lowish white colorless powder. It is pre- manufacturing practice. The ingre- pared by reacting sodium dient may also be used in infant for- pyrophosphate with ferric citrate. mula in accordance with section 412(g) (b) The ingredient meets the speci- of the Federal Food, Drug, and Cos- fications of the Food Chemicals Codex, metic Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under 3d Ed. (1981), p. 120, which is incor- section 412(a)(2) of the act (21 U.S.C. porated by reference. Copies are avail- 350a(a)(2)). able from the National Academy Press, (d) 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. [53 FR 16865, May 12, 1988] (c) In accordance with § 184.1(b)(1), § 184.1301 Ferric phosphate. the ingredient is used in food as a nu- trient supplement as defined in (a) Ferric phosphate (ferric § 170.3(o)(20) of this chapter, with no orthophosphate, iron (III) phosphate, limitation other than current good FePO ·xH O, CAS Reg. No. 10045–86–0) is 4 2 manufacturing practice. The ingre- an odorless, yellowish-white to buff- colored powder and contains from one dient may also be used in infant for- to four molecules of water of hydra- mula in accordance with section 412(g) tion. It is prepared by reaction of so- of the Federal Food, Drug, and Cos- dium phosphate with ferric chloride or metic Act (the act) (21 U.S.C. 350a(g)) ferric citrate. or with regulations promulgated under (b) The ingredient meets the speci- section 412(a)(2) of the act (21 U.S.C. fications of the Food Chemicals Codex, 350a(a)(2)). 3d Ed. (1981), pp. 118–120, 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 Ave. NW., Wash- waived. ington, DC 20418, or available for in- [53 FR 16865, May 12, 1988; 53 FR 20939, June spection at the Office of the Federal 7, 1988] Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. § 184.1307 Ferric sulfate. (c) In accordance with § 184.1(b)(1), the ingredient is used in food as nutri- (a) Ferric sulfate (iron (III) sulfate, ent supplement as defined in Fe2(SO4)3, CAS Reg. No. 10028–22–5) is a § 170.3(o)(20) of this chapter, with no yellow substance that may be prepared limitation other than current good by oxidizing iron (II) sulfate or by manufacturing practice. The ingre- treating ferric oxide or ferric hydrox- dient may also be used in infant for- ide with sulfuric acid. mula in accordance with section 412(g) (b) The Food and Drug Administra- of the Federal Food, Drug, and Cos- tion is developing food-grade specifica- metic Act (the act) (21 U.S.C. 350a(g)) tions for ferric sulfate in cooperation or with regulations promulgated under with the National Academy of
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Sciences. In the interim, this ingre- dient 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 of this chapter, with no limitation limitation other than current good other than current good manufacturing manufacturing practice. The ingre- practice. dient may also be used in infant for- (d) Prior sanctions for this ingredient mula in accordance with section 412(g) different from the uses established in of the Federal Foods, Drug, and Cos- this section do not exist or have been metic Act (the act) (21 U.S.C. 350a(g)) waived. or with regulations promulgated under [53 FR 16865, May 12, 1988] section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). § 184.1307a Ferrous ascorbate. (d) Prior sanctions for this ingredient (a) Ferrous ascorbate (CAS Reg. No. different from the uses established in 14536–17–5) is a reaction product of fer- this section do not exist or have been rous hydroxide and ascorbic acid. It is waived. a blue-violet product containing 16 per- [53 FR 16865, May 12, 1988] cent iron. (b) The Food and Drug Administra- § 184.1307c Ferrous citrate. tion is developing food-grade specifica- (a) Ferrous citrate (iron (II) citrate, tions for ferrous ascorbate in coopera- (C H FeO ), CAS Reg. No. 23383–11–1) is tion with the National Academy of 6 6 7 a slightly colored powder or white Sciences. In the interim, this ingre- crystals. It is prepared from the reac- dient must be of a purity suitable for tion of sodium citrate with ferrous sul- its intended use. fate or by direct action of citric acid on (c) In accordance with § 184.1(b)(1), iron filings. the ingredient is used in food as a nu- trient supplement as defined in (b) The Food and Drug Administra- § 170.3(o)(20) of this chapter, with no tion is developing food-grade specifica- limitation other than current good tions for ferrous citrate in cooperation manufacturing practice. The ingre- with the National Academy of dient may also be used in infant for- Sciences. In the interim, this ingre- mula in accordance with section 412(g) dient must be of a purity suitable for of the Federal Food, Drug, and Cos- its intended use. metic Act (the act) (21 U.S.C. 350a(g)) (c) In accordance with § 184.1(b)(1) the or with regulations promulgated under ingredient is used in food as a nutrient section 412(a)(2) of the act (21 U.S.C. supplement as defined in § 170.3(o)(20) of 350a(a)(2)). this chapter, with no limitation other (d) Prior sanctions for this ingredient than current good manufacturing prac- different from the uses established in tice. The ingredient may also be used this section do not exist or have been in infant formula in accordance with waived. section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 [53 FR 16865, May 12, 1988] U.S.C. 350a(g)) or with regulations pro- mulgated under section 412(a)(2) of the § 184.1307b Ferrous carbonate. act (21 U.S.C. 350a(a)(2)). (a) Ferrous carbonate (iron (II) car- (d) Prior sanctions for this ingredient bonate, FeCO3, CAS Reg. No. 563–71–3) different from the uses established in is an odorless, white solid prepared by this section do not exist or have been treating solutions of iron (II) salts with waived. alkali carbonate salts. (b) The Food and Drug Administra- [53 FR 16866, May 12, 1988] tion is developing food-grade specifica- tions for ferrous carbonate in coopera- § 184.1307d Ferrous fumarate. tion with the National Academy of (a) Ferrous fumarate (iron (II) fuma- Sciences. In the interim, this ingre- rate, (C4H2FeO4), CAS Reg. No. 141–01–5) 497
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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 (b) The ingredient meets the speci- section 412(a)(2) of the act (21 U.S.C. fications of the Food Chemicals Codex, 350a(a)(2)). 3d Ed. (1981), pp. 120–122, which is incor- (d) Prior sanctions for this ingredient porated by reference. Copies are avail- able from the National Academy Press, different from the uses established in 2101 Constitution Ave NW., Wash- this section do not exist or have been ington, DC 20418, or available for in- waived. spection at the Office of the Federal [53 FR 16866, May 12, 1988; 53 FR 20939, June Register, 800 North Capitol Street, 7, 1988] NW., suite 700, Washington, DC 20408. (c) In accordance with § 184.1(b)(1) the § 184.1311 Ferrous lactate. ingredient is used in food as a nutrient (a) Ferrous lactate (iron (II) lactate, supplement as defined in § 170.3(o)(20) of this chapter, with no limitation other C6H10FeO6, CAS Reg. No. 5905–52–2) in than current good manufacturing prac- the trihydrate form is a greenish-white tice. The ingredient may also be used powder or crystalline mass. It is pre- in infant formula in accordance with pared by reacting calcium lactate or section 412(g) of the Federal Food, sodium lactate with ferrous sulfate, di- Drug, and Cosmetic Act (the act) (21 rect reaction of lactic acid with iron U.S.C. 350a(g)), or with regulations pro- filings, reaction of ferrous chloride mulgated under section 412(a)(2) of the with sodium lactate, or reaction of fer- act (21 U.S.C. 350a(a)(2)). rous sulfate with ammonium lactate. (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 4th ed. (1996), pp. 154 to 155, which is in- waived. corporated by reference in accordance [53 FR 16866, May 12, 1988] with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National § 184.1308 Ferrous gluconate. Academy Press, 2101 Constitution Ave. (a) Ferrous gluconate (iron (II) gluco- NW., Washington, DC 20418, or may be nate dihydrate, C12H22FeO14·2H2O, CAS examined at the Center for Food Safety Reg. No. 6047-12-7) is a fine yellowish- and Applied Nutrition’s library, 200 C gray or pale greenish-yellow powder or St. SW., rm. 3321, Washington, DC, or granules. It is prepared by reacting hot at the Office of the Federal Register, solutions of barium or calcium gluco- 800 North Capitol St. NW., suite 700, nate with ferrous sulfate or by heating Washington, DC. freshly prepared ferrous carbonate with (c) In accordance with § 184.1(b)(1), gluconic acid in aqueous solution. the ingredient is used in food as a nu- (b) The ingredient meets the speci- trient supplement as defined in fications of the Food Chemcials Codex, § 170.3(o)(20) of this chapter and as a 3d Ed. (1981), pp. 122–123, which is incor- porated by reference. Copies are avail- color fixative for ripe olives, with no able from the National Academy Press, other limitation other than current 2101 Constitution Avenue NW., Wash- good manufacturing practice. The in- ington, DC 20418, or available for in- gredient may also be used in infant for- spection at the Office of the Federal mula in accordance with section 412(g) Register, 800 North Capitol Street, of the Federal Food, Drug, and Cos- NW., suite 700, Washington, DC 20408. metic Act (the act) (21 U.S.C. 350a(g)) (c) In accordance with § 184.1(b)(1), or with regulations promulgated under the ingredient is used in food as a nu- section 412(a)(2) of the act (21 U.S.C. trient supplement as defined in 350a(a)(2)). § 170.3(o)(20) of this chapter, with no (d) Prior sanctions for this ingredient limitation other than current good different from the uses established in
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this section do not exist or have been Its characterizing enzyme activity is waived. that of a peptide hydrolase (EC 3.4.22.3). [53 FR 16866, May 12, 1988, as amended at 61 FR 40319, Aug. 2, 1996] (b) The ingredient meets the general requirements and additional require- § 184.1315 Ferrous sulfate. ments for enzyme preparations in the 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 FeSO4·7H2O, CAS Reg. No. 7782–63–0) is CFR part 51. Copies are available from prepared by the action of sulfuric acid the National Academy Press, 2101 Con- on iron. It occurs as pale, bluish-green stitution Ave., NW., Washington, DC crystals or granules. Progressive heat- 20418, or may be examined at the Office ing of ferrous sulfate heptahydrate pro- of Premarket Approval (HFS–200), Food duces ferrous sulfate (dried). Ferrous and Drug Administration, 200 C St., sulfate (dried) consists primarily of fer- SW., Washington, DC, and the Office of rous sulfate monohydrate (CAS Reg. the Federal Register, 800 North Capitol No. 17375–41–6) with varying amounts of St., NW., suite 700, Washington, DC. ferrous sulfate tetrahydrate (CAS Reg. (c) In accordance with § 184.1(b)(1), No. 20908–72–9) and occurs as a grayish- the ingredient is used in food with no white to buff-colored powder. limitation other than current good (b) The ingredients meet the speci- manufacturing practice. The affirma- fications of the Food Chemicals Codex, tion of this ingredient as GRAS as a di- 3d Ed. (1981), p. 123 (Ferrous sulfate rect food ingredient is based upon the heptahydrate) and p. 124 (ferrous sul- following current good manufacturing fate, dried), which is incorporated by practice conditions of use: reference. Copies are available from (1) The ingredient is used as an en- the National Academy Press, 2101 Con- zyme as defined in § 170.3(o)(9) of this stitution Ave., NW., Washington, DC chapter to hydrolyze proteins or 20418, or available for inspection at the polypeptides. Office of Federal Register, 800 North (2) The ingredient is used in food at Capitol Street, NW., suite 700, Wash- levels not to exceed current good man- ington, DC 20408. ufacturing practice. (c) In accordance with § 184.1(b)(1), the ingredients are used in food as nu- [60 FR 32910, June 26, 1995] trient supplements as defined in § 184.1317 Garlic and its derivatives. § 170.3(o)(20) of this chapter and as a processing aid as defined in § 170.3(o)(24) (a) Garlic is the fresh or dehydrated of this chapter, with no limitation bulb or cloves obtained from Allium other than current good manufacturing sativum, a genus of the lily family. Its practice. The ingredients may also be derivatives include essential oils, oleo- used in infant formula in accordance resins, and natural extractives ob- with section 412(g) of the Federal Food, tained from garlic. Drug, and Cosmetic Act (the act) (21 (b) Garlic oil meets the specifications U.S.C. 350a(g)) or with regulations pro- of the ‘‘Food Chemicals Codex,’’ 3d Ed. mulgated under section 412(a)(2) of the (1981), p. 132, which is incorporated by act (21 U.S.C. 350a(a)(2)). reference. Copies may be obtained from (d) Prior sanctions for these ingredi- the National Academy Press, 2101 Con- ents different from the uses established stitution Ave. NW., Washington, DC in this section do not exist or have 20418, or may be examined at the Office been waived. of the Federal Register, 800 North Cap- itol Street, NW., suite 700, Washington, [53 FR 16866, May 12, 1988] DC 20408. (c) Garlic and its derivatives are used § 184.1316 Ficin. as flavoring agents and adjuvants as (a) Ficin (CAS Reg. No. 9001–33–6) is defined in § 170.3(o)(12) of this chapter. an enzyme preparation obtained from (d) The ingredients are used in food the latex of species of the genus Ficus, at levels not to exceed good manufac- which include a variety of tropical fig turing practice. trees. It is a white to off-white powder. (e) [Reserved]
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(f) 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 [51 FR 33896, Sept. 24, 1986] waived. [42 FR 14653, Mar. 15, 1977, as amended at 42 § 184.1321 Corn gluten. FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, (a) Corn gluten (CAS Reg. No. 66071– 1984] 96–3), also known as corn gluten meal, is the principal protein component of § 184.1318 Glucono delta-lactone. corn endosperm. It consists mainly of (a) Glucono delta-lactone (C6H10O6, zein and glutelin. Corn gluten is a by- CAS Reg. No. 90–80–2), also called D- product of the wet milling of corn for gluconic acid delta-lactone or D- starch. The gluten fraction is washed glucono-1,5-lactone, is the cyclic 1,5- to remove residual water soluble pro- intramolecular ester of D-gluconic teins. Corn gluten is also produced as a acid. It is prepared by direct crys- byproduct during the conversion of the tallization from the aqueous solution starch in whole or various fractions of of gluconic acid. Gluconic acid may be dry milled corn to corn syrups. produced by the oxidation of D-glucose (b) FDA is developing food-grade with bromine water, by the oxidation specifications for corn gluten in co- of D-glucose by microorganisms that operation with the National Academy are nonpathogenic and nontoxicogenic of Sciences. In the interim, the ingre- dient must be of a purity suitable for to man or other animals, or by the oxi- its intended use. dation of D-glucose with enzymes de- (c) In accordance with § 184.1(b)(1), rived from these microorganisms. the ingredient is used in food with no (b) The ingredient meets the speci- limitation other than current good fications of the Food Chemicals Codex, manufacturing practice. The affirma- 3d Ed. (1981), p. 134, which is incor- tion of this ingredient as generally rec- porated by reference. Copies are avail- ognized as safe (GRAS) as a direct able from the National Academy Press, human food ingredient is based upon 2101 Constitution Ave. NW., Wash- the following current good manufac- ington, DC 20418, or available for in- turing practice conditions of use: spection at the Office of the Federal (1) The ingredient is used as a nutri- Register, 800 North Capitol Street, ent supplement as defined in NW., suite 700, Washington, DC 20408. § 170.3(o)(20) of this chapter and a (c) In accordance with § 184.1(b)(1), texturizer as defined in § 170.3(o)(32) of the ingredient is used in food with no this chapter. limitation other than current good (2) The ingredient is used in food 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 a curing [50 FR 8998, Mar. 6, 1985] and pickling agent as defined in § 170.3(o)(5) of this chapter, leavening § 184.1322 Wheat gluten. agent as defined in § 170.3(o)(17) of this (a) Wheat gluten (CAS Reg. No. 8002– chapter; pH control agent as defined in 80–0) is the principal protein compo- § 170.3(o)(23) of this chapter; and nent of wheat and consists mainly of sequestrant as defined in § 170.3(o)(26) of gliadin and glutenin. Wheat gluten is this chapter. obtained by hydrating wheat flour and (2) The ingredient is used at levels mechanically working the sticky mass not to exceed current good manufac- to separate the wheat gluten from the turing practice. starch and other flour components. (d) Prior sanctions for this ingredient Vital gluten is dried gluten that has re- different from the uses established in tained its elastic properties.
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(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- tion of this ingredient as generally rec- lowing foods at levels not to exceed ognized as safe (GRAS) as a direct current good manufacturing practice: human food ingredient is based upon baked goods and baking mixes as de- the following current good manufac- fined in § 170.3(n)(1) of this chapter; turing practice conditions of use: nonalcoholic beverages and beverage (1) The ingredient is used as a dough bases as defined in § 170.3(n)(3) of this strengthener as defined in § 170.3(o)(6) chapter; chewing gum as defined in of this chapter; a formulation aid as § 170.3(n)(6) of this chapter; and meat defined in § 170.3(o)(14) of this chapter; products as defined in § 170.3(n)(29) of a nutrient supplement as defined in this chapter. § 170.3(o)(20) of this chapter; a proc- (d) Prior sanctions for this ingredient essing aid as defined in § 170.3(o)(24) of different from the use established in this chapter; a stabilizer and thickener this section do not exist or have been as defined in § 170.3(o)(28) of this chap- waived. ter; a surface-finishing agent as defined in § 170.3(o)(30) of this chapter; and a [54 FR 7403 Feb. 21, 1989] texturizing agent as defined in § 170.3(o)(32) of this chapter. § 184.1324 Glyceryl monostearate. (2) The ingredient is used in food at (a) Glyceryl monostearate, also levels not to exceed current good man- known as monostearin, is a mixture of ufacturing practice. variable proportions of glyceryl mono- (d) Prior sanctions for this ingredient stearate (C H O CAS Reg. No. 31566– different from the uses established in 21 42 4, 31–1), glyceryl monopalmitate this section do not exist or have been waived. (C19H38O4, CAS Reg. No. 26657–96–5) and glyceryl esters of fatty acids present in [50 FR 8998, Mar. 6, 1985] commercial stearic acid. Glyceryl monostearate is prepared by § 184.1323 Glyceryl monooleate. glycerolysis of certain fats or oils that (a) Glyceryl monooleate is prepared are derived from edible sources or by by esterification of commerical oleic esterification, with glycerin, of stearic acid that is derived either from edible acid that is derived from edible sources or from tall oil fatty acids sources. meeting the requirements of § 172.862 of this chapter. It contains glyceryl (b) FDA is developing food-grade specifications for glyceryl monostea- monooleate (C21H40O4, CAS Reg. No. 25496–72–4) and glyceryl esters of fatty rate in cooperation with the National acids present in commercial oleic acid. Academy of Sciences. In the interim, (b) FDA is developing food-grade this ingredient must be of a purity specifications for glyceryl monooleate suitable for its intended use. in cooperation with the National Acad- (c) In accordance with § 184.1(b)(1), emy of Sciences. In the interim, this the ingredient is used in food with no ingredient must be of a purity suitable limitation other than current good for its intended use. manufacturing 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 do not not exist or have manufacturing practice. The affirma- been waived. tion of this ingredient as generally rec- ognized as safe (GRAS) as a direct [54 FR 7403 Feb. 21, 1989]
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§ 184.1328 Glyceryl behenate. made from glycerin, palmitic acid, and stearic acid. (a) Glyceryl behenate is a mixture of (b) The ingredient meets the fol- glyceryl esters of behenic acid made lowing specifications: from glycerin and behenic acid (a satu- (1) The substance is a mixture of rated C fatty acid). The mixture con- 22 mono-, di-, and triglycerides of pal- tains predominately glyceryl mitic acid and stearic acid. dibehenate. (2) Heavy metals (as lead): Not more (b) The ingredient meets the fol- than 10 parts per million. lowing specifications: (c) In accordance with § 184.1(b)(1), (1) 10 to 20 percent monoglyceride, 47 the ingredient is used in food with no to 59 percent diglyceride, 26 to 38 per- limitation other than current good cent triglyceride, and not more than manufacturing practice. The affirma- 2.5 percent free fatty acids. tion of this ingredient as generally rec- (2) Behenic acid. Between 80 and 90 ognized as safe (GRAS) as a direct percent of the total fatty acid content. human food ingredient is based upon (3) Acid value. Not more than 4. the following current good manufac- (4) Saponification value. Between 145 turing practice conditions of use: and 165. (1) The ingredient is used as a formu- (5) Iodine number. Not more than 3. lation aid, as defined in § 170.3(o)(14) of (6) Heavy metals (as Pb). Not more this chapter. than 10 parts per million. (2) The ingredient is used in excipient (c) In accordance with § 184.1(b)(1) of formulations for use in tablets at levels this chapter, the ingredient is used in not to exceed good manufacturing food with no limitation other than cur- practice. rent good manufacturing practice. The affirmation of this ingredient is gen- [60 FR 63621, Dec. 12, 1995] erally recognized as safe (GRAS) as a § 184.1330 Acacia (gum arabic). direct human food ingredient is based upon the following current good manu- (a) Acacia (gum arabic) is the dried facturing practice conditions of use: gummy exudate from stems and (1) The ingredient is used as a formu- branches of trees of various species of lation aid, as defined in § 170.3(o)(14) of the genus Acacia, family Leguminosae. this chapter. (b) The ingredient meets the speci- (2) The ingredient is used in excipient fications of the ‘‘Food Chemicals formulations for use in tablets at levels Codex,’’ 3d Ed. (1981), p. 7, which is in- not to exceed good manufacturing corporated by reference. Copies may be practice. obtained from the National Academy Press, 2101 Constitution Ave. NW., [52 FR 42430, Nov. 5, 1987] Washington, DC 20418, or may be exam- ined at the Office of the Federal Reg- § 184.1329 Glyceryl palmitostearate. ister, 800 North Capitol Street, NW., (a) Glyceryl palmitostearate is a suite 700, Washington, DC 20408. mixture of mono-, di-, and triglyceryl (c) The ingredient is used in food esters of palmitic and stearic acids 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 chap- ter; formulation aid, ¤ 170.3(o)(14) of this chapter; sta- bilizer 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.
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MAXIMUM USAGE LEVELS PERMITTED—Continued
Food (as served) Percent Function
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-fin- ishing 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; formu- lation 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 chap- ter; formulation aid, ¤ 170.3(o)(14) of this chapter; proc- essing 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] (v) Lead. Not more than 10 parts per (e) Prior sanctions for this ingredient million (0.001 percent). different from the uses established in (3) Loss on drying. Not more than 14 this section do not exist or have been percent dried at 105 °C for 5 hours. waived. (4) Identification test. Add 0.2 ml of di- [42 FR 14653, Mar. 15, 1977, as amended at 42 luted lead acetate as outlined in ‘‘Offi- FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, cial Methods of Analysis of the Asso- 1983; 53 FR 5766, Feb. 26, 1988] ciation of Official Analytical Chem- ists,’’ 13th Ed. (1980), section 31.178(b), § 184.1333 Gum ghatti. p. 529, under ‘‘Dilute Basic Lead Ace- (a) Gum ghatti (Indian gum) is an tate Standard Solution,’’ which is in- exudate from wounds in the bark of corporated by reference (copies are Anogeissus latifolia, a large tree found available from the Association of Offi- in the dry deciduous forests of India cial Analytical Chemists, P.O. Box 540, and Ceylon. Benjamin Franklin Station, Wash- (b) The ingredient complies with the ington, DC 20044, or may be examined following specifications: at the Office of the Federal Register, (1) Viscosity of a 1-percent solution. Not less than the minimum or within 800 North Capitol Street, NW., suite the range claimed by the vendor. 700, Washington, DC 20408), to 5 ml of a (2) Limits of impurities—(i) Arsenic (as cold 1-in-100 aqueous solution of the AL). Not more than 3 parts per million gum. An immediate, voluminous, (0.0003 percent); opaque precipitate indicates acacia. A (ii) Ash (acid-insoluble). Not more small precipitate or clear solution than 1.75 percent; which produces an opaque flocculent (iii) Ash (total). Not more than 6.0 precipitate upon the additon of 1 ml of percent; 3 N ammonimum hydroxide indicates (iv) Heavy metals (as Pb). Not more gum ghatti. than 40 parts per million (0.004 per- (c) The ingredient is used in food cent); and under the following conditions:
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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. 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] § 184.1343 Locust (carob) bean gum. (e) Prior sanctions for this ingredient (a) Locust (carob) bean gum is pri- different from the uses established in marily the macerated endosperm of the this section do not exist or have been seed of the locust (carob) bean tree, waived. Ceratonia siliqua (Linne), a leguminous [42 FR 14653, Mar. 15, 1977, as amended at 42 evergreen tree, with lesser quantities FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, of seed coat and germ. 1984] (b) The ingredient meets the speci- fications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), pp. 174–175, which is incorporated by reference. Copies
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may be obtained from the National Register, 800 North Capitol Street, Academy Press, 2101 Constitution Ave. NW., suite 700, Washington, DC 20408. NW., Washington, DC 20418, or may be (c) The ingredient is used at levels examined at the Office of the Federal not to exceed the following maximum 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 in- corporated 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 exam- ined 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. 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 in- corporated 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 exam- ined 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:
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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] (2) The ingredient is used in food at (e) 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 this section do not exist or have been [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, waived. 1984] [48 FR 57270, Dec. 29, 1983]
§ 184.1355 Helium. § 184.1366 Hydrogen peroxide.
(a) Helium (empirical formula He, (a) Hydrogen peroxide (H2O2, CAS CAS Reg. No. 7440–59–7) is a colorless, Reg. No. 7722–84–1) is also referred to as odorless, flavorless, nonflammable, hydrogen dioxide. It is made by the inert gas. It is lighter than air and is electrolytic oxidation of sulfuric acid produced by the liquefaction and puri- or a sulfate to persulfuric acid or a fication of natural gas. persulfuric acid salt with subsequent (b) The Food and Drug Administra- hydrolysis and distillation of the hy- tion is developing food-grade specifica- drogen peroxide formed; by decomposi- tions for helium in cooperation with tion of barium peroxide with sulfuric the National Academy of Sciences. In or phosphoric acid; by hydrogen reduc- the interim, the ingredient must be of tion of 2-ethylanthraquinone, followed a purity suitable for its intended use. by oxidation with air, to regenerate (c) In accordance with § 184.1(b)(1), the quinone and produce hydrogen per- the ingredient is used in food with no oxide; or by electrical discharge limitations other than current good through a mixture of hydrogen, oxy- manufacturing practice. The affirma- gen, and water vapor. 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), pp. 146–147,1 which is incor- the following current good manufac- porated by reference. turing practice conditions of use: (c) In accordance with § 184.1(b)(2), (1) The ingredient is used as a proc- the ingredient is used to treat food essing aid as defined in § 170.3(o)(24) of only within the following specific limi- this chapter. tations:
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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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 refin- ing. 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- ington, DC 20418, or available for in- moved by appropriate physical and spection at the Office of the Federal chemical means during the processing Register, 800 North Capitol Street, of food where it has been used accord- NW., suite 700, Washington, DC 20408. ing to paragraph (c) of this section. (c) In accordance with § 184.1(b)(1), (e) Prior sanctions for this ingredient the ingredient is used in food with no different from the uses established in limitations other than current good this section do not exist or have been manufacturing practice. The affirma- waived. tion of this ingredient as generally rec- [46 FR 44439, Sept. 4, 1981, as amended at 51 ognized as safe (GRAS) as a direct FR 27172, July 30, 1986] human food ingredient is based upon the following current good manufac- § 184.1370 Inositol. turing practice conditions of use: (1) The ingredient is used as a nutri- (a) Inositol, or myo-inositol (C6H12O6, CAS Reg. No. 87–89–8), is cis-1,2,3,5- ent supplement as defined in trans-4,6-cyclohexanehexol. It occurs § 170.3(o)(20) of this chapter. naturally and is prepared from an (2) The ingredient is used in special aqueous (0.2 percent sulfur dioxide) ex- dietary foods as defined in part 105 of tract of corn kernels by precipitation this chapter at levels not to exceed and hydrolysis of crude phytate. current good manufacturing practice. (b) The ingredient meets the speci- It may also be used in infant formula fications of the Food Chemicals Codex, in accordance with section 412(g) of the 3d Ed. (1981), p. 150, which is incor- Act, or with regulations promulgated porated by reference. Copies are avail- under section 412(a)(2) of the Act. able from the National Academy Press, (d) Prior sanctions for this ingredient 2101 Constitution Ave. NW., Wash- different from the uses established by
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this section do not exist or have been any of the following processes: reduced waived. iron, electrolytic iron, and carbonyl iron. [47 FR 38278, Aug. 31, 1982] (1) Reduced iron is prepared by react- § 184.1372 Insoluble glucose isomerase ing ground ferric oxide with hydrogen enzyme preparations. or carbon monoxide at an elevated 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. that produces no antibiotics. They are (3) Carbonyl iron is prepared by the fixed (rendered insoluble) for batch decomposition of iron pentacarbonyl. production with GRAS ingredients or It occurs as a dark gray powder. When may be fixed for further immobiliza- viewed under a microscope, it appears tion with either GRAS ingredients or as spheres built up with concentric materials approved under § 173.357 of shells. It is stable in dry air. this chapter. (b) Iron, elemental (carbonyl, elec- (b) The ingredient meets the general trolytic, or reduced) meets the speci- and additional requirements for en- fications of the Food Chemicals Codex, zyme preparations in the Food Chemi- 3d Ed. (1981) (iron, carbonyl, p. 151; cals Codex, 3d Ed. (1981), p. 107, which is iron, electrolytic, pp. 151–152; iron, re- incorporated by reference. Copies are duced; pp. 152–153), which is incor- available from the National Academy porated by reference. Copies are avail- Press, 2101 Constitution Ave. NW., able from the National Academy Press, Washington, DC 20418, or available for 2101 Constitution Ave. NW., Wash- inspection 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)(1), NW., suite 700, Washington, DC 20408. the ingredient is used in food with no (c) In accordance with § 184.1(b)(1), limitation other than current good the ingredient is used in food as a nu- manufacturing practice. The affirma- trient supplement as defined in tion of this ingredient as generally rec- § 170.3(o)(20) of this chapter, with no ognized as safe (GRAS) as a direct limitation other than current good human food ingredient is based upon manufacturing practice. The ingre- the following current good manufac- dient may also be used in accordance turing practice conditions of use: with section 412(g) of the Federal Food, (1) The ingredient is used as an en- Drug, and Cosmetic Act (the act) (21 zyme, as defined in § 170.3(o)(9) of this U.S.C. 350a(g)) or with regulations pro- chapter, to convert glucose to fructose. mulgated under section 412(a)(2) of the (2) The ingredient is used in high act (21 U.S.C. 350a(2)). fructose corn syrup, at levels not to ex- (d) Prior sanctions for this ingredient ceed current good manufacturing prac- different from the uses established in tice. this section do not exist or have been waived. [48 FR 5720, Feb. 8, 1983, as amended at 61 FR 43450, Aug. 23, 1996] [53 FR 16867, May 12, 1988]
§ 184.1375 Iron, elemental. § 184.1386 Isopropyl citrate. (a) Iron, elemental (CAS Reg. No. (a) Isopropyl citrate is a mixture of 7439–89–6) is metallic iron obtained by the mono-, di-, and triisopropyl esters
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of citric acid. It is prepared by available from the National Academy esterifying citric acid with Press, 2101 Constitution Ave. NW., isopropanol. Washington, DC 20418, or may be exam- (b) The Food and Drug Administra- ined at the Center for Food Safety and tion, in cooperation with the National Applied Nutrition’s Library, 200 C St. Academy of Sciences, is developing SW., rm. 3321, Washington, DC, or at food-grade specifications for isopropyl the Office of the Federal Register, 800 citrate. In the interim, this ingredient North Capitol St. NW., suite 700, Wash- must be of a purity suitable for its in- ington, DC. tended use. (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 limitations other than current good limitation other than current good manufacturing practice. The affirma- manufacturing practice. The affirma- tion of this ingredient as generally rec- tion of this ingredient as generally rec- ognized as safe as a direct human food ognized as safe (GRAS) as a direct ingredient is based upon the following human food ingredient is based upon current good manufacturing practice the following current good manufac- conditions of use: turing practice conditions of use: (1) The ingredient is used as an en- (1) The ingredient is used as an anti- zyme, as defined in § 170.3(o)(9) of this oxidant as defined in § 170.3(o)(3) of this chapter, to convert lactose to glucose chapter; a sequestrant as defined in and galactose. § 170.3(o)(26) of this chapter; and a sol- (2) The ingredient is used in food at vent and vehicle as defined in levels not to exceed current good man- § 170.3(o)(27) of this chapter. (2) The ingredient is used in mar- ufacturing practice. Current good man- garine in accordance with § 166.110 of ufacturing practice is limited to use of this chapter; in nonalcoholic beverages this ingredient to reduce the lactose as defined in § 170.3(n)(3) of this chap- content in milk and milk-derived food ter; and in fats and oils as defined in products where food standards do not § 170.3(n)(12) of this chapter at levels preclude such use. not to exceed current good manufac- [61 FR 7704, Feb. 29, 1996] turing practice. (d) Prior sanctions for this ingredient § 184.1388 Lactase enzyme preparation different from the uses established in from Kluyveromyces lactis. this section, or different from those set (a) This enzyme preparation is de- forth in part 181 of this chapter, do not rived from the nonpathogenic, exist or have been waived. nontoxicogenic yeast Kluyveromyces [59 FR 63896, Dec. 12, 1994] lactis (previously named Saccharomyces lactis). It contains the enzyme Β- § 184.1387 Lactase enzyme preparation galactoside galactohydrase (CAS Reg. from Candida pseudotropicalis. No. CBS 683), which converts lactose to (a) This enzyme preparation is de- glucose and galactose. It is prepared rived from the nonpathogenic, from yeast that has been grown in a nontoxicogenic yeast C. pure culture fermentation and by using pseudotropicalis. It contains the enzyme materials that are generally recognized lactase (β-D-galactoside as safe or are food additives that have galactohydrolase, EC 3.2.1.23), which been approved for this use by the Food converts lactose to glucose and galac- and Drug Administration. tose. It is prepared from yeast that has (b) The ingredient meets the general been grown by a pure culture fermenta- and additional requirements for en- tion process. zyme preparations in the Food Chemi- (b) The ingredient meets the general cals Codex, 3d Ed. (1981), p. 107–110, requirements and additional require- which is incorporated by reference. ments for enzyme preparations in the Copies are available from the National Food Chemicals Codex, 3d ed. (1981), pp. Academy Press, 2101 Constitution Ave. 107–110, which are incorporated by ref- NW., Washington, DC 20418, or avail- erence in accordance with 5 U.S.C. able for inspection at the Office of the 552(a) and 1 CFR part 51. Copies are Federal Register, 800 North Capitol
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Street, NW., suite 700, Washington, DC § 184.1408 Licorice and licorice deriva- 20408. tives. (c) In accordance with § 184.1(b)(1), (a)(1) Licorice (glycyrrhiza) root is the ingredient is used in food with no the dried and ground rhizome and root limitation other than current good portions of Glycyrrhiza glabra or other manufacturing practice. The affirma- species of Glycyrrhiza. Licorice extract tion of this ingredient as generally rec- is that portion of the licorice root that ognized as safe as a direct human food is, after maceration, extracted by boil- ingredient is based upon the following ing water. The extract can be further current good manufacturing practice purified by filtration and by treatment conditions of use: with acids and ethyl alcohol. Licorice (1) The ingredient is used as an en- extract is sold as a liquid, paste zyme as defined in §170.3(o)(9) of this (‘‘block’’), or spray-dried powder. chapter to convert lactose to glucose (2) Ammoniated glycyrrhizin is pre- and galactose. pared from the water extract of lico- 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 dient in milk to produce lactase-treat- glycyrrhizin by solvent extraction and ed milk, which contains less lactose separation techniques. than regular milk, or lactose-reduced (b) The ingredients shall meet the milk, which contains at least 70 per- following specifications when analyzed: cent less lactose than regular milk. (1) Assay. The glycyrrhizin content of [49 FR 47387, Dec. 4, 1984] each flavoring ingredient shall be de- termined by the method in the Official § 184.1400 Lecithin. Methods of Analysis of the Association of Official Analytical Chemists, 13th (a) Commercial lecithin is a natu- Ed., §§ 19.136–19.140, which is incor- rally occurring mixture of the porated by reference, or by methods phosphatides of choline, ethanolamine, 19.CO1 through 19.CO4 in the Journal of and inositol, with smaller amounts of the Association of Official Analytical othe lipids. It is isolated as a gum fol- Chemists, 65:471–472 (1982), which are lowing hydration of solvent-extracted also incorporated by reference. Copies soy, safflower, or corn oils. Lecithin is of all of these methods are available bleached, if desired, by hydrogen per- from the Association of Official Ana- oxide and benzoyl peroxide and dried lytical Chemists, 2200 Wilson Blvd., by heating. Suite 400, Arlington, VA 22201–3301, or (b) The ingredient meets the speci- available for inspection at the Office of fications of the Food Chemicals Codex, the Federal Register, 800 North Capitol 3d Ed. (1981), pp. 166–167, which is incor- Street, NW., suite 700, Washington, DC porated by reference. Copies are avail- 20408. able from the National Academy Press, (2) Ash. Not more than 9.5 percent for 2101 Constitution Ave. NW., Wash- licorice, 2.5 percent for ammoniated ington, DC 20418, or available for in- glycyrrhizin, and 0.5 percent for spection at the Office of the Federal monoammonium glycyrrhizinate on an Register, 800 North Capitol Street, anhydrous basis as determined by the NW., suite 700, Washington, DC 20408. method in the Food Chemicals Codex, (c) In accordance with § 184.1(b)(1), 3d Ed. (1981), p. 466, which is incor- the ingredient is used in food with no porated by reference. Copies are avail- limitation other than current good able from the National Academy Press, manufacturing 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. (3) Acid unsoluble ash. Not more than [48 FR 51150, Nov. 7, 1983] 2.5 percent for licorice on an anhydrous
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basis as determined by the method in (5) Arsenic (As). Not more than 3 parts the Food Chemicals Codex, 3d Ed. per million as determined by the meth- (1981), p. 466, which is incorporated by od in the Food Chemicals Codex. 3d Ed. reference. (1981), p. 464, which is incorporated by (4) Heavy metals (as Pb). Not more reference. than 40 parts per million as determined (c) In accordance with § 184.1(b)(2), by method II in the Food Chemicals these ingredients are used in food only Codex, 3d Ed. (1981), p. 512, which is in- within the following specific limita- corporated by reference. 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; fla- voring 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; fla- voring agent, ¤170.3(o)(12) of this chapter; sur- face-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; fla- voring 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 (d) Prior sanctions for this ingredient different from the uses established in different from the uses established in this section do not exist or have been this section do not exist or have been waived. waived. [50 FR 21044, May 22, 1985, as amended at 54 [48 FR 52442, Nov. 18, 1983] FR 24899, June 12, 1989] § 184.1415 Animal lipase. § 184.1409 Ground limestone. (a) Animal lipase (CAS Reg. No. 9001– (a) Ground limestone consists essen- 62–1) is an enzyme preparation obtained tially (not less than 94 percent) of cal- from edible forestomach tissue of calves, kids, or lambs, or from animal cium carbonate (CaCO ) and is prepared 3 pancreatic tissue. The enzyme prepara- by the crushing, grinding, and tion may be produced as a tissue prepa- classifying of naturally occurring lime- ration or as an aqueous extract. Its stone. characterizing enzyme activity is that (b) The ingredient meets the speci- of a triacylglycerol hydrolase (EC fications of the Food Chemicals Codex, 3.1.1.3). 3d Ed. (1981), p. 173, which is incor- (b) The ingredient meets the general porated by reference. Copies are avail- requirements and additional require- able from the National Academy Press, ments for enzyme preparations in the 2101 Constitution Ave. NW., Wash- Food Chemicals Codex, 3d ed. (1981), p. ington, DC 20418, or available for in- 110, which is incorporated by reference spection at the Office of the Federal in accordance with 5 U.S.C. 552(a) and 1 Register, 800 North Capitol Street, CFR part 51. Copies are available from NW., suite 700, Washington, DC 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 may be examined at the Office limitation other than current good of Premarket Approval (HFS–200), Food manufacturing practice. and Drug Administration, 200 C St.,
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SW., Washington, DC, and the Office of current good manufacturing practice the Federal Register, 800 North Capitol conditions of use: St., NW., suite 700, Washington, DC. (1) The ingredient is used as an en- (c) In accordance with § 184.1(b)(1), zyme as defined in § 170.3(o)(9) of this the ingredient is used in food with no chapter for the interesterification of limitation other than current good fats and oils. manufacturing practice. The affirma- (2) The ingredient is used in food at tion of this ingredient as GRAS as a di- levels not to exceed current good man- rect food ingredient is based upon the ufacturing practice. following current good manufacturing practice conditions of use: [63 FR 24419, May 4, 1998] (1) The ingredient is used as an en- zyme 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 (2) The ingredient is used in food at (MgCO3)4·Mg(OH)2·5H2O, CAS Reg. No. levels not to exceed current good man- 39409–82–0) is also known as magnesium ufacturing practice. carbonate hydroxide. It is a white pow- [60 FR 32911, June 26, 1995] der formed either by adding an alkaline carbonate (such as sodium carbonate) § 184.1420 Lipase enzyme preparation to a solution of magnesium sulfate or derived from Rhizopus niveus. by carbonation of a slurry of magne- (a) Lipase enzyme preparation con- sium hydroxide followed by boiling of tains lipase enzyme (CAS Reg. No. the resulting magnesium carbonate. 9001–62–1), which is obtained from the (b) The ingredient meets the speci- culture filtrate resulting from a pure fications of the Food Chemicals Codex, culture fermentation of a nonpatho- 3d Ed. (1981), p. 177, which is incor- genic and nontoxigenic strain of porated by reference. Copies are avail- Rhizopus niveus. The enzyme prepara- able from the National Academy Press, tion also contains diatomaceous earth 2101 Constitution Ave. NW., Wash- as a carrier. The characterizing activ- ington, DC 20418, or available for in- ity of the enzyme, which catalyzes the spection at the Office of the Federal interesterification of fats and oils at Register, 800 North Capitol Street, the 1- and 3-positions of triglycerides, NW., suite 700, Washington, DC 20408. is triacylglycerol lipase (EC 3.1.1.3). (c) In accordance with § 184.1(b)(1), (b) The ingredient meets the general the ingredient is used in food with no requirements and additional require- limitation other than current good ments for enzyme preparations in the manufacturing practice. The affirma- monograph on Enzyme Preparations in tion of this ingredient as generally rec- the ‘‘Food Chemicals Codex,’’ 4th ed. ognized as safe (GRAS) as a direct (1996), pp. 133 and 134, which is incor- human food ingredient is based upon porated by reference in accordance the following current good manufac- with 5 U.S.C. 552(a) and 1 CFR part 51. turing practice conditions of use: Copies are available from the National (1) The ingredient is used as an Academy Press, 2101 Constitution Ave. anticaking and free-flow agent as de- NW., Washington, DC 20418, or may be fined in § 170.3(o)(1) of this chapter; a examined at the Center for Food Safety flour treating agent as defined in and Applied Nutrition’s Library, 200 C § 170.3(o)(13) of this chapter; a lubricant St. SW., rm. 3321, Washington, DC, or and release agent as defined in the Office of the Federal Register, 800 § 170.3(o)(18) of this chapter; a nutrient North Capitol St. NW., suite 700, Wash- supplement as defined in § 170.3(o)(20) of ington, DC. this chapter; a pH control agent as de- (c) In accordance with § 184.1(b)(1), fined in § 170.3(o)(23) of this chapter; a the ingredient is used in food with no processing aid as defined in § 170.3(o)(24) limitation other than current good of this chapter; and a synergist as de- manufacturing practice. The affirma- fined in § 170.3(o)(31) of this chapter. tion of this ingredient as generally rec- (2) The ingredient is used in foods at ognized as safe as a direct human food levels not to exceed current good man- ingredient is based upon the following ufacturing practice.
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(d) Prior sanctions for this ingredient § 184.1428 Magnesium hydroxide. different from the uses established in (a) Magnesium hydroxide (Mg(OH)2, this section do not exist or have been CAS Reg. No. 1309–42–8) occurs natu- waived. rally as the colorless, crystalline min- [50 FR 13558, Apr. 5, 1985; 50 FR 16080, Apr. 24, eral brucite. It is prepared as a white 1985] precipitate by the addition of sodium hydroxide to a water soluble magne- § 184.1426 Magnesium chloride. sium salt or by hydration of reactive (a) Magnesium chloride (MgC1 ·6H O, grades of magnesium oxide. 2 2 (b) The ingredient meets the speci- CAS Reg. No. 7786–30–3) is a colorless, fications of the Food Chemicals Codex, deliquescent, crystalline material that 3d Ed. (1981), p. 178, which is incor- occurs naturally as the mineral porated by reference. Copies are avail- bischofite. It is prepared by dissolving able from the National Academy Press, magnesium oxide, hydroxide, or car- 2101 Constitution Ave. NW., Wash- bonate in aqueous hydrochloric acid so- ington, DC 20418, or available for in- lution and crystallizing out magnesium spection at the Office of the Federal chloride hexahydrate. Register, 800 North Capitol Street, (b) The ingredient meets the speci- NW., suite 700, Washington, DC 20408. fications of the Food Chemicals Codex, (c) In accordance with § 184.1(b)(1), 3d Ed. (1981), p. 177, which is incor- the ingredient is used in food with no porated by reference. Copies are avail- limitation other than current good able from the National Academy Press, manufacturing practice. The affirma- 2101 Constitution Ave. NW., Wash- tion of this ingredient as generally rec- ington, DC 20418, or available for in- ognized as safe (GRAS) as a direct spection at the Office of the Federal human food ingredient is based upon 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 nutri- the ingredient is used in food with no ent supplement as defined in limitation other than current good § 170.3(o)(20) of this chapter; a pH con- trol agent as defined in § 170.3(o)(23) of manufacturing practice. The affirma- this chapter; and a processing aid as tion of this ingredient as generally rec- defined in § 170.3(o)(24) of this chapter. ognized as safe (GRAS) as a direct (2) The ingredient is used in foods at human food ingredient is based upon levels not to exceed current good man- the following current good manufac- ufacturing practice. turing practice conditions of use: (d) Prior sanctions for this ingredient (1) The ingredient is used as a fla- different from the uses established in voring agent and adjuvant as defined in this section do not exist or have been § 170.3(o)(12) of this chapter and a nutri- waived. ent supplement as defined in § 170.3(o)(20) of this chapter. [50 FR 13559, Apr. 5, 1985, as amended at 64 FR 405, Jan. 5, 1999] (2) The ingredient is used in foods at levels not to exceed current good man- § 184.1431 Magnesium oxide. ufacturing practice. The ingredient (a) Magnesium oxide (MgO, CAS Reg. also may be used in infant formula in No. 1309–48–4) occurs naturally as the accordance with section 412(g) of the colorless, crystalline mineral periclase. Federal Food, Drug, and Cosmetic Act It is produced either as a bulky white (the act) or with regulations promul- powder (light) or a relatively dense gated under section 412(a)(2) of the act. white powder (heavy) by heating mag- (d) Prior sanctions for this ingredient nesium hydroxide or carbonate. Heat- different from the uses established in ing these magnesium salts under mod- this section do not exist or have been erate conditions (400° to 900 °C for a few waived. hours) produces light magnesium oxide. Heating the salts under more [50 FR 13559, Apr. 5, 1985; 50 FR 16080, Apr. 24, rigorous conditions (1200 °C for 12 1985] hours) produces heavy magnesium
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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 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 an manufacturing practice. The affirma- anticaking and free-flow agent as de- tion of this ingredient as generally rec- fined in § 170.3(o)(1) of this chapter; a ognized as safe (GRAS) as a direct firming agent as defined in § 170.3(o)(10) human food ingredient is based upon of this chapter; a lubricant and release the following current good manufac- agent as defined in § 170.3(o)(18) of this turing practice conditions of use: chapter; a nutrient supplement as de- (1) The ingredient is used as a nutri- fined in § 170.3(o)(20) of this chapter; ent supplement as defined in and a pH control agent as defined in § 170.3(o)(23) of this chapter. § 170.3(o)(20) of this chapter and a pH (2) The ingredient is used in foods at control agent as defined in § 170.3(o)(23) levels not be exceed current good man- of this chapter. ufacturing practice. The ingredient (2) The ingredient is used in foods at also may be used in infant formula in levels not to exceed current good man- accordance with section 412(g) of the ufacturing practice. The ingredient Federal Food, Drug, and Cosmetic Act also may be used in infant formula in (the act) or with regulations promul- accordance with section 412(g) of the gated under section 412(a)(2) of the act. Federal Food, Drug, and Cosmetic Act (d) Prior sanctions for this ingredient (the act) or with regulations promul- different from the uses established in gated under section 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 this section do not exist or have been [50 FR 13559, Apr. 5, 1985] waived. § 184.1434 Magnesium phosphate. [50 FR 13560, Apr. 5, 1985] (a) Magnesium phosphate includes both magnesium phosphate, dibasic, § 184.1440 Magnesium stearate. and magnesium phosphate, tribasic. (a) Magnesium stearate Magnesium phosphate, dibasic (Mg(C17H34COO)2, CAS Reg. No. 557–04–0) (MgHPO4·3H2O, CAS Reg. No. 7782–0975– is the magnesium salt of stearic acid. 094) occurs naturally as the white, It is produced as a white precipitate by crystalline mineral newberyite. It is the addition of an aqueous solution of prepared commercially as a precipitate magnesium chloride to an aqueous so- formed by treating a solution of mag- lution of sodium stearate derived from nesium sulfate with disodium phos- stearic acid that is obtained from edi- phate under controlled conditions. ble sources and that conforms to the
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requirements of § 172.860(b)(2) of this ognized as safe (GRAS) as a direct 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 Register, 800 North Capitol Street, § 170.3(o)(24) of this chapter. NW., suite 700, Washington, DC 20408. (2) The ingredient is used in foods at (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 the following current good manufac- [50 FR 13560, Apr. 5, 1985] turing practice conditions of use: (1) The ingredient is used as a lubri- § 184.1443a Malt. cant and release agent as defined in (a) Malt is an enzyme preparation ob- § 170.3(o)(18) of this chapter; a nutrient tained from barley which has been soft- supplement as defined in § 170.3(o)(20) of ened by a series of steeping operations this chapter; and a processing aid as and germinated under controlled condi- defined in § 170.3(o)(24) of this chapter. tions. It is a brown, sweet, and viscous (2) The ingredient is used in foods at liquid or a white to tan powder. Its levels not to exceed current good man- characterizing enzyme activities are α- ufacturing practice. amylase (EC 3.2.1.1.) and β-amylase (EC (d) Prior sanctions for this ingredient 3.2.1.2). different from the uses established in (b) The ingredient meets the general this section do not exist or have been requirements and additional require- waived. ments for enzyme preparations in the [50 FR 13560, Apr. 5, 1985] Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference § 184.1443 Magnesium sulfate. in accordance with 5 U.S.C. 552(a) and 1 (a) Magnesium sulfate (MgSO4·7H2O, CFR part 51. Copies are available from CAS Reg. No. 10034–99–8) occurs natu- the National Academy Press, 2101 Con- rally as the mineral epsomite. It is pre- stitution Ave., NW., Washington, DC pared by neutralization of magnesium 20418, or may be examined at the Office oxide, hydroxide, or carbonate with of Premarket Approval (HFS–200), Food sulfuric acid and evaporating the solu- and Drug Administration, 200 C St., tion to crystallization. SW., Washington, DC, and the Office of (b) The ingredient meets the speci- the Federal Register, 800 North Capitol fications of the Food Chemicals Codex, St., NW., suite 700, Washington, DC. 3d Ed. (1981), p. 183, which is incor- 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 GRAS as a di- Register, 800 North Capitol Street, rect food ingredient is based upon the NW., suite 700, Washington, DC 20408. 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. The affirma- chapter to hydrolyze starch or starch- tion of this ingredient as generally rec- derived polysaccharides.
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(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 ((C H O ) CAS 6 10 5 n, (a) Malt is the product of barley Reg. No. 9050–36–6) is a nonsweet nutri- (Hordeum vulgare L.) germinated under tive saccharide polymer that consists controlled conditions. Malt syrup and of D-glucose units linked primarily by malt extract are interchangeable terms α -1-4 bonds and that has a dextrose for a viscous concentrate of water ex- equivalent (D.E.) of less than 20. It is tract of germinated barley grain, with prepared as a white powder or con- or without added safe preservative. centrated solution by partial hydrol- Malt syrup is usually a brown, sweet, ysis of corn starch, potato starch, or and viscous liquid containing varying rice starch with safe and suitable acids amounts of amylolytic enzymes and and enzymes. plant constituents. Barley is first soft- (b)(1) Maltodextrin derived from corn ened after cleaning by steeping oper- starch must be of a purity suitable for ations and then allowed to germinate its intended use. under controlled conditions. The ger- (2) Maltodextrin derived from potato minated grain then undergoes proc- starch meets the specifications of the essing, such as drying, grinding, ex- Food Chemicals Codex, 3d ed., 3d supp. tracting, filtering, and evaporating, to (1992), p. 125, which are incorporated by produce malt syrup (malt extract) with reference in accordance with 5 U.S.C. 75 to 80 percent solids or dried malt 552(a) and 1 CFR part 51. Copies are syrup with higher solids content. available from the National Academy (b) FDA is developing food-grade Press, 2101 Constitution Ave., NW., specifications for malt syrup (malt ex- Washington, DC 20418, or may be exam- tract) in cooperation with the National ined at the Office of the Federal Reg- Academy of Sciences. In the interim, ister, 800 North Capital St. NW., suite the ingredient must be of a purity suit- 700, Washington, DC 20408, or at the Di- able for its intended use. vision of Petition Control (HFS–217), (c) In accordance with § 184.1(b)(1), Center for Food Safety and Applied Nu- the ingredient is used in food with no trition, Food and Drug Administration, limitation other than current good 200 C St. SW., Washington, DC 20204. manufacturing practice. The affirma- (3) Maltodextrin derived from rice tion of this ingredient as generally rec- starch meets the specifications of the ognized as safe (GRAS) as a direct Food Chemicals Codex, 4th ed. (1996), human food ingredient is based upon pp. 239 and 240, which is incorporated the following current good manufac- by reference in accordance with 5 turing practice conditions of use: U.S.C. 552(a) and 1 CFR part 51. Copies (1) The ingredient is used as a fla- are available from the National Acad- voring agent and adjuvant as defined in emy Press, 2101 Constitution Ave. NW., § 170.3(o)(12) of this chapter. Washington, DC 20418, or may be exam- (2) The ingredient is used in food at ined at the Center for Food Safety and levels not to exceed current good man- Applied Nutrition’s Library, 200 C St. ufacturing practice. SW., rm. 3321, Washington, DC, or at (d) Prior sanctions for this ingredient the Office of the Federal Register, 800 different from the uses established in North Capitol St. NW., suite 700, Wash- this section do not exist or have been ington, DC. waived. (c) In accordance with § 184.1(b)(1), [48 FR 51613, Nov. 10, 1983] the ingredient is used in food with no limitation other than current good § 184.1446 Manganese chloride.
manufacturing practice. (a) Manganese chloride (MnCl2·4H2O, (d) Prior sanctions for this ingredient CAS Reg. No. 7773–01–5) is a pink, different from the uses established in translucent, crystalline product. It is
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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 tion of this ingredient as generally rec- chapter; meat products as defined in ognized as safe (GRAS) as a direct § 170.3(n)(29) of this chapter; milk prod- human food ingredient is based upon ucts as defined in § 170.3(n)(31) of this the following current good manufac- chapter; and poultry products as de- turing practice conditions of use: fined in § 170.3(n)(34) of this chapter. (1) The ingredient is used as a nutri- The ingredient may be used in infant ent supplement as defined in formulas in accordance with section § 170.3(o)(20) of this chapter. 412(g) of the Federal Food, Drug, and (2) The ingredient may be used in in- Cosmetic Act (the act) or with regula- fant formulas in accordance with sec- tions promulgated under section tion 412(g) of the Federal Food, Drug, 412(a)(2) of the act. and Cosmetic Act (the act) or with reg- (d) Prior sanctions for this ingredient ulations 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. § 184.1452 Manganese gluconate. [50 FR 19165, May 7, 1985] (a) Manganese gluconate (C12H22MnO14·2H2O, CAS Reg. No. 648– § 184.1449 Manganese citrate. 0953–0998) is a slightly pink colored (a) Manganese citrate (Mn3(C6H5O7)2, powder. It is obtained by reacting man- CAS Reg. No. 1002–46–65) is a pale or- ganese carbonate with gluconic acid in ange or pinkish white powder. It is ob- aqueous medium and then crystallizing tained by precipitating manganese car- the product. bonate from manganese sulfate and so- (b) The ingredient meets the speci- dium carbonate solutions. The filtered fications of the Food Chemicals Codex, and washed precipitate is digested first 3d Ed. (1981), p. 186, which is incor- with sufficient citric acid solution to porated by reference. Copies are avail- form manganous citrate and then with able from the National Academy Press, sodium citrate to complete the reac- 2101 Constitution Ave. NW., Wash- tion. ington, DC 20418, or available for in- (b) FDA is developing food-grade spection at the Office of the Federal specifications for manganese citrate in Register, 800 North Capitol Street, cooperation with the National Acad- NW., suite 700, Washington, DC 20408. emy of Sciences. In the interim, this (c) In accordance with § 184.1(b)(1), ingredient must be of purity suitable the ingredient is used in food with no for its intended use. 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 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 chapter; meat products as defined in defined in § 170.3(n)(3) of this chapter; § 170.3(n)(29) of this chapter; milk prod- dairy product analogs as defined in ucts as defined in § 170.3(n)(31) of this § 170.3(n)(10) of this chapter; fish prod- chapter; and poultry products as de- ucts as defined in § 170.3(n(13) of this fined in § 170.3(n)(34) of this chapter. chapter; meat products as defined in The ingredient may be used in infant § 170.3(n)(29) of this chapter; milk prod- formulas in accordance with section ucts as defined in § 170.3(n)(31) of this 412(g) of the Federal Food, Drug, and chapter; and poultry products as de- Cosmetic Act (the act) or with regula- fined in § 170.3(n)(34) of this chapter. tions promulgated under section The ingredient may be used in infant 412(a)(2) of the act. formulas in accordance with section (d) Prior sanctions for this ingredient 412(g) of the Federal Food, Drug, and different from the uses established in Cosmetic Act (the act) or with regula- this section do not exist or have been tions promulgated under section waived. 412(a)(2) of the act. [50 FR 19166, May 7, 1985] (d) Prior sanctions for this ingredient different from the uses established in § 184.1461 Manganese sulfate. this section do not exist or have been waived. (a) Manganese sulfate (MnSO4·H2O, CAS Reg. No. 7785–0987–097) is a pale [50 FR 19166, May 7, 1985] pink, granular, odorless powder. It is obtained by reacting manganese com- § 184.1472 Menhaden oil. pounds with sulfuric acid. It is also ob- tained as a byproduct in the manufac- (a) Menhaden oil. (1) Menhaden oil is ture of hydroquinone. Other manufac- prepared from fish of the genus turing processes include the action of Brevoortia, commonly known as menha- sulfur dioxide on a slurry of manganese den, by cooking and pressing. The re- dioxide in sulfuric acid, and the roast- sulting crude oil is then refined using the following steps: Storage (winteriza- ing of pyrolusite (MnO2) ore with solid ferrous sulfate and coal, followed by tion), degumming (optional), neutral- leaching and crystallization. ization, bleaching, and deodorization. (b) The ingredient meets the speci- Winterization may separate the oil and fications of the Food Chemicals Codex, produce a solid fraction. 3d Ed. (1981), p. 188, which is incor- (2) Menhaden oil meets the following porated by reference. Copies are avail- specifications: able from the National Academy Press, (i) Color and state. Yellow liquid to 2101 Constitution Ave. NW., Wash- white solid. ington, DC 20418, or available for in- (ii) Odor. Odorless to slightly fishy. spection at the Office of the Federal (iii) Saponification value. Between 180 Register, 800 North Capitol Street, and 200 as determined by the American NW., suite 700, Washington, DC 20408. Oil Chemists’ Society Official Method
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Cd 3–25—‘‘Saponification Value’’ (re- by reference is given in paragraph approved 1989), which is incorporated (a)(2)(iii) of this section. by reference in accordance with 5 (viii) Lead. Not more than 0.1 part U.S.C. 552(a) and 1 CFR part 51. Copies per million as determined by the Amer- of this publication are available from ican Oil Chemists’ Society Official the Office of Premarket Approval, Cen- Method Ca 18c–91—‘‘Determination of ter for Food Safety and Applied Nutri- Lead by Direct Graphite Furnace tion (HFS–200), Food and Drug Admin- Atomic Absorption Spectrometry’’ (re- istration, 200 C St. SW., Washington, vised 1992), which is incorporated by DC 20204, or available for inspection at reference in accordance with 5 U.S.C. the Center for Food Safety and Applied 552(a) and 1 CFR part 51. The avail- Nutrition’s Library, Food and Drug Ad- ability of this incorporation by ref- ministration, 200 C St. SW., rm. 3321, erence is given in paragraph (a)(2)(iii) Washington DC, or at the Office of the of this section. Federal Register, 800 North Capitol St. (ix) Mercury. Not more than 0.5 part NW., 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 Method,’’ which is incorporated by ref- Dolah and S. B. Galloway, editors, Na- erence in accordance with 5 U.S.C. tional Marine Fisheries Service, U. S. 552(a) and 1 CFR part 51. The avail- Department of Commerce, pages 71–88, ability of this incorporation by ref- November, 1988, which is incorporated erence is given in paragraph (a)(2)(iii) by reference in accordance with 5 of this section. U.S.C. 552(a) and 1 CFR part 51. The (v) Unsaponifiable matter. Not more availability of this incorporation by than 1.5 percent as determined by the reference is given in paragraph American Oil Chemists’ Society Offi- (a)(2)(iii) of this section. cial Method Ca 6b–53—‘‘Unsaponifiable (3) In accordance with § 184.1(b)(2), Matter’’ (reapproved 1989), which is in- the ingredient may be used in food only corporated by reference in accordance within the following specific limita- with 5 U.S.C. 552(a) and 1 CFR part 51. tions: The availability of this incorporation Maximum level of use by reference is given in paragraph Category of food in food (as served) (a)(2)(iii) of this section. Cookies, crackers, ¤ 170.3(n)(1) of 5.0 percent (vi) Free fatty acids. Not more than 0.1 this chapter. percent as determined by the American Breads, rolls (white & dark), 1.0 percent Oil Chemists’ Society Official Method ¤ 170.3(n)(1) of this chapter. Ca 5a–40—‘‘Free Fatty Acids’’ (re- Fruit pies, custard pies, ¤ 170.3(n)(1) 7.0 percent of this chapter. approved 1989), which is incorporated Cakes, ¤ 170.3(n)(1) of this chapter .. 10.0 percent by reference in accordance with 5 Cereals, ¤ 170.3(n)(4) of this chapter 4.0 percent U.S.C. 552(a) and 1 CFR part 51. The Fats, oils, ¤ 170.3(n)(12) of this chap- 20.0 percent ter, but not in infant formula. availability of this incorporation by Yogurt, ¤ 170.3(n)(31) of this chapter 4.0 percent reference is given in paragraph Cheese products, ¤ 170.3(n)(5) of 5.0 percent (a)(2)(iii) of this section. this chapter. Frozen dairy products, ¤ 170.3(n)(20) 5.0 percent (vii) Peroxide value. Not more than 5 of this chapter. milliequivalents per kilogram of oil as Meat products, ¤ 170.3(n)(29) of this 10.0 percent determined by the American Oil Chem- chapter. Egg products, ¤ 170.3(n)(11) of this 5.0 percent ists’ Society Official Method Cd 8–53— chapter. ‘‘Peroxide Value, Acetic Acid—Chloro- Fish products, ¤ 170.3(n)(13) of this 20.0 percent form Method’’ (updated 1992) or Rec- chapter. ommended Practice Cd 8b–90—‘‘Per- Condiments, ¤ 170.3(n)(8) of this 5.0 percent chapter. oxide Value, Acetic Acid—Isooctane Soup mixes, ¤ 170.3(n)(40) of this 3.0 percent Method’’ (updated 1992), which are in- chapter. corporated by reference in accordance Snack foods, ¤ 170.3(n)(37) of this 5.0 percent chapter. with 5 U.S.C. 552(a) and 1 CFR part 51. Nut products, ¤ 170.3(n)(32) of this 5.0 percent The availability of this incorporation chapter.
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Maximum level of use § 184.1490 Methylparaben. Category of food in food (as served) (a) Methylparaben is the chemical Gravies, sauces, ¤ 170.3(n)(24) of 5.0 percent methyl p-hydroxybenzoate. It is pro- this chapter. duced by the methanol esterification of p-hydroxybenzoic acid in the presence (b) Hydrogenated and partially hydro- of sulfuric acid, with subsequent dis- genated menhaden oils. (1) Partially hy- tillation. drogenated and hydrogenated menha- (b) The ingredient meets the speci- den oils are prepared by feeding hydro- fications of the ‘‘Food Chemicals gen gas under pressure to a converter Codex,’’ 3d Ed. (1981), p. 199, which is in- containing crude menhaden oil and a corporated by reference. Copies may be nickel catalyst. The reaction is begun obtained from the National Academy at 150 to 160 cC and after 1 hour the Press, 2101 Constitution Ave. NW., temperature is raised to 180 cC until Washington, DC 20418, or may be exam- the desired degree of hydrogenation is ined at the Office of the Federal Reg- reached. Hydrogenated menhaden oil is ister, 800 North Capitol Street, NW., fully hydrogenated. suite 700, Washington, DC 20408. (2) Partially hydrogenated and hy- (c) The ingredient is used as an anti- drogenated menhaden oils meet the fol- microbial agent as defined in lowing specifications: § 170.3(o)(2) of this chapter. (i) Color. Opaque white solid. (d) The ingredient is used in food at (ii) Odor. Odorless. levels not to exceed good manufac- (iii) Saponification value. Between 180 turing practices. Current good manu- and 200. facturing practice results in a max- (iv) Iodine number. Not more than 119 imum level of 0.1 percent in food. for partially hydrogenated menhaden (e) Prior sanctions for this ingredient oil and not more than 10 for fully hy- different from the uses established in drogenated menhaden oil. this regulation do not exist or have (v) Unsaponifiable matter. Not more been waived. than 1.5 percent.– [42 FR 14653, Mar. 15, 1977, as amended at 49 (vi) Free fatty acids. Not more than 0.1 FR 5612, Feb. 14, 1984] percent. (vii) Peroxide value. Not more than 5 § 184.1498 Microparticulated protein milliequivalents per kilogram of oil. product. (viii) Nickel. Not more than 0.5 part (a) Microparticulated protein product per million. is prepared from egg whites or milk (ix) Mercury. Not more than 0.5 part protein or a combination of egg whites per million. and milk protein. These protein (x) Arsenic (as As). Not more than 0.1 sources may be used alone or in com- part per million. bination with other safe and suitable (xi) Lead. Not more than 0.1 part per ingredients to form the million. microparticulated product. The mix- (3) Partially hydrogenated and hy- ture of ingredients is high-shear heat drogenated menhaden oils are used as processed to achieve a smooth and edible fats or oils, as defined in creamy texture similar to that of fat. § 170.3(n)(12) of this chapter, in food at Safe and suitable ingredients used in levels not to exceed current good man- the preparation of the ufacturing practice. microparticulated protein product must be used in compliance with the (4) If the fat or oil is fully hydro- limitations of the appropriate regula- genated, the name to be used on the tions in parts 172, 182, and 184 of this label of a product containing it shall chapter. include the term ‘‘hydrogenated,’’ or if it is partially hydrogenated, the name (b) The ingredient is used in food in shall include the term ‘‘partially hy- accordance with § 184.1(b)(2) at levels drogenated,’’ in accordance with not to exceed current good manufac- § 101.4(b)(14) of this chapter. turing practice. The affirmation of the use of this ingredient as generally rec- [62 FR 30756, June 5, 1997] ognized as safe (GRAS) as a direct
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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- must be used in accordance with this active agent as defined in §170.3(o)(29) requirement or its addition to food will of this chapter; a surface-finishing be considered by FDA to constitute the agent as defined in § 170.3(o)(30) of this use of an unapproved food additive (see chapter; and a texturizer as defined in § 184.1(b)(2)). § 170.3(o)(32) of this chapter. [55 FR 6391, Feb. 23, 1990] (2) The ingredient is used in food at levels not to exceed current good man- § 184.1505 Mono- and diglycerides. ufacturing practice. (a) Mono- and diglycerides consist of (d) Prior sanctions for this ingredient a mixture of glyceryl mono- and different from the uses established in diesters, and minor amounts of this section do not exist or have been triesters, that are prepared from fats waived. or oils or fat-forming acids that are de- [54 FR 7403, Feb. 21, 1989, as amended at 57 rived from edible sources. The most FR 10616, Mar.27, 1992] prevalent fatty acids include lauric, linoleic, myristic, oleic, palmitic, and § 184.1521 Monosodium phosphate de- stearic. Mono- and diglycerides are rivatives of mono- and diglycerides. manufactured by the reaction of glyc- (a) Monosodium phophate derivatives erin with fatty acids or the reaction of of mono- and diglycerides are com- glycerin with triglycerides in the pres- posed of glyceride derivatives formed ence of an alkaline catalyst. The prod- by reacting mono- and diglycerides ucts are further purified to obtain a that are derived from edible sources mixture of glycerides, free fatty acids, with phosphorus pentoxide and free glycerin that contains at least (tetraphosphorus decoxide) followed by 90 percent-by-weight glycerides. neutralization with sodium carbonate. (b) The ingredient meets the speci- (b) FDA is developing food-grade fications of the Food Chemicals Codex, specifications for monosodium phos- 3d Ed. (1981), p. 201, which is incor- phate mono- and diglycerides in co- porated by reference in accordance operation with the National Academy with 5 U.S.C. 552(a). Copies are avail- of Sciences. In the interim, this ingre- able from the National Academy Press, dient must be of a purity suitable for 2101 Constitution Ave. NW., Wash- its intended use. 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 20005. 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
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human food ingredient is based upon (1) The ingredient is used as a nutri- the following current good manufac- ent supplement as defined in turing practice conditions of use: § 170.3(o)(20) of this chapter. (1) The ingredient is used in food as (2) The ingredient is used in foods at an emulsifier and emulsifier salt as de- levels not to exceed current good man- fined in § 170.3(o)(8) of this chapter, a ufacturing practice. The ingredient lubricant and release agent as defined may also be used in infant formula in in § 170.3(o)(18) of this chapter, and as a accordance with section 412(g) of the surface-active agent as defined in Federal Food, Drug, and Cosmetic Act § 170.3(o)(29) of this chapter. (the Act) or with regulations promul- gated under section 412(a)(2) of the Act. (2) The ingredient is used in the fol- (d) Prior sanctions for this ingredient lowing foods at levels not to exceed different from the uses established in current good manufacturing practice: this section do not exist or have been dairy product analogs as defined in waived. § 170.3(n)(10) of this chapter and soft candy as defined in § 170.3(n)(38) of this [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. chapter. 2, 1983, as amended at 64 FR 1760, Jan. 12, 1999] (d) Prior sanctions for this ingredient different from the uses established in § 184.1535 Niacinamide. this section do not exist or have been (a) Niacinamide (C H N O, CAS Reg. waived. 6 6 2 No. 98–92–0) is the chemical 3- [54 FR 7404, Feb. 21, 1989] pyridinecarboxylic acid amide (nicotin- amide). It is a white crystalline powder § 184.1530 Niacin. that is soluble in water, alcohol, ether, ° (a) Niacin (C H NO CAS Reg. No. 59– and glycerol. It melts between 128 and 6 5 2, ° 67–6) is the chemical 3- 131 C. pyridinecarboxylic acid (nicotinic (b) The ingredient meets the speci- acid). It is a non-hygroscopic, stable, fications of the Food Chemicals Codex, white, crystalline solid that sublimes 3d Ed. (1981), p. 205, which is incor- porated by reference. Copies are avail- without decomposition at about 230 °C. able from the National Academy Press, It is soluble in water and alcohol. It is 2101 Constitution Ave. NW., Wash- insoluble in ether. 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 Register, 800 North Capitol Street, Codex,’’ 4th ed. (1996), p. 264, which is NW., suite 700, Washington, DC 20408. incorporated by reference in accord- (c) In accordance with § 184.1(b)(1), ance with 5 U.S.C. 552(a) and 1 CFR the ingredient is used in food with no part 51. Copies are available from the limitation other than current good National Academy Press, Box 285, 2101 manufacturing practice. The affirma- Constitution Ave. NW., Washington, tion of this ingredient as generally rec- DC 20055 (Internet address ‘‘http:// ognized as safe (GRAS) as a direct www.nap.edu’’), or may be examined at human food ingredient is based upon the Center for Food Safety and Applied the following current good manufac- Nutrition’s Library, Food and Drug Ad- turing practice conditions of use: ministration, 200 C St. SW., rm. 3321, (1) The ingredient is used as a nutri- Washington, DC, or at the Office of the ent supplement as defined in Federal Register, 800 North Capitol St. § 170.3(o)(20) of this chapter. NW., suite 700, Washington, DC. (2) The ingredient is used in foods at (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. The ingredient limitation other than current good may also be used in infant formula in manufacturing practice. The affirma- accordance with section 412(g) of the tion of this ingredient as generally rec- Federal Food, Drug, and Cosmetic Act ognized as safe (GRAS) as direct (the act) or with regulations promul- human food ingredient is based upon gated under section 412(a)(2) of the Act. the following current good manufac- (d) Prior sanctions for this ingredient turing practice conditions of use: different from the uses established in
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this section do not exist or have been World Health Organization, FAO Nutri- waived. tion Meeting Report Series, No. 45A, 1969, which is incorporated by ref- [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. 2, 1983] erence. Copies are available from the Dockets Management Branch (HFA– § 184.1537 Nickel. 305), Food and Drug Administration, (a) Elemental nickel (CAS Reg. No. rm. 1–23, 12420 Parklawn Dr., Rockville, 7440–02–0) is obtained from nickel ore MD 20857, or available for inspection at by transforming it to nickel sulfide the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, (Ni3S2). The sulfide is roasted in air to give nickel oxide (NiO). The oxide is 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. interim, this ingredient must be of a (4) Zinc, not more than 25 parts per purity suitable for its intended use. million. (c) In accordance with § 184.1(b)(1), (5) Copper, zinc plus copper not more the ingredient is used in food with no than 50 parts per million. limitation other than current good (6) Total plate count, not more than manufacturing practice. The affirma- 10 per gram. tion of this ingredient as generally rec- (7) Escherichia coli, absent in 10 ognized as safe (GRAS) as a direct grams. human food ingredient is based upon (8) Salmonella, absent in 10 grams. the following current good manufac- (9) Coagulase positive staphylococci, turing practice conditions of use: absent in 10 grams. (1) The ingredient is used as a cata- (c) The ingredient is used as an anti- lyst as defined in § 170.3(o)(24) of this microbial agent as defined in chapter. § 170.3(o)(2) of this chapter to inhibit (2) The ingredient is used in the hy- the outgrowth of Clostridium botulinum drogenation of fats and oils as defined spores and toxin formation in pasteur- in § 170.3(n)(12) of this chapter at levels ized cheese spreads and pasteurized not to exceed current good manufac- process cheese spreads listed in turing practice. Current good manufac- § 133.175; pasteurized cheese spread with turing practice includes the removal of fruits, vegetables, or meats as defined nickel from fats and oils following hy- in § 133.176; pasteurized process cheese drogenation. spread as defined in § 133.179; pasteur- (d) Prior sanctions for this ingredient ized process cheese spread with fruits, different from the uses established in vegetables, or meats as defined in this section do not exist or have been § 133.180 of this chapter. waived. (d) The ingredient is used at levels not to exceed good manufacturing [48 FR 51618, Nov. 10, 1983] practice in accordance with § 184.1(b)(1) of this chapter. The current good man- § 184.1538 Nisin preparation. ufacturing practice level is the quan- (a) Nisin preparation is derived from tity of the ingredient that delivers a pure culture fermentations of certain maximum of 250 parts per million of strains of Streptococcus lactis nisin in the finished product as deter- Lancefield Group N. Nisin preparation mined by the British Standards Insti- contains nisin (CAS Reg. No. 1414–45–5), tution Methods, ‘‘Methods for the Esti- a group of related peptides with anti- mation and Differentiation of Nisin in biotic activity. Processed Cheese,’’ BS 4020 (1974), (b) The ingredient is a concentrate or which is incorporated by reference. dry material that meets the specifica- Copies are available from the Dockets tions that follow when it is tested as Management Branch (HFA–305), Food described in ‘‘Specifications for Iden- and Drug Administration, rm. 1–23, tity and Purity of Some Antibiotics,’’ 12420 Parklawn Dr., Rockville, MD
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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 limitations other than current good [53 FR 11250, Apr. 6, 1988, as amended at 59 FR 14364, Mar. 28, 1994] manufacturing practice. The affirma- tion of this ingredient as generally rec- § 184.1540 Nitrogen. ognized as safe (GRAS) as a direct 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 the National Academy of Sciences. In not to exceed current good manufac- the interim, the ingredient must be of turing practice. a purity suitable for its intended use. (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 limitations other than current good waived. manufacturing practice. The affirma- tion of this ingredient as generally rec- [48 FR 57270, Dec. 29, 1983] ognized as safe (GRAS) as a direct § 184.1553 Peptones. human food ingredient is based upon the following current good manufac- (a) Peptones are a variable mixture turing practice conditions of use: of polypeptides, oligopeptides, and (1) The ingredient is used as a propel- amino acids that are produced by par- lant, aerating agent, and gas as defined tial hydrolysis of casein, animal tissue, in § 170.3(o)(25) of this chapter. soy protein isolate, gelatin, defatted (2) The ingredient is used in food at fatty tissue, egg albumin, or lactal- levels not to exceed current good man- bumin (whey protein). Peptones are ufacturing practice. produced from these proteins using (d) Prior sanctions for this ingredient proteolytic enzymes that either are different from the uses established in considered to be generally recognized this section do not exist or have been as safe (GRAS) or are regulated as food waived. additives. Peptones are also produced by denaturing any of the proteins list- [48 FR 57270, Dec. 29, 1983] ed in this paragraph with safe and suit- able acids or heat. § 184.1545 Nitrous oxide. (b) FDA is developing food-grade (a) Nitrous oxide (empirical formula specifications for peptones in coopera- N2O, CAS Reg. No. 10024–97–2) is also tion with the National Academy of known as dinitrogen monoxide or Sciences. In the interim, these ingredi- laughing gas. It is a colorless gas, ents must be of a purity suitable for about 50 percent heavier than air, with their intended use. a slightly sweet smell. It does not burn (c) In accordance with § 184.1(b)(1), but will support combustion. Nitrous these ingredients are used in food with oxide is manufactured by the thermal no limitation other than current good decomposition of ammonium nitrate. manufacturing practice. The affirma- Higher oxides of nitrogen are removed tion of these ingredients as GRAS as by passing the dry gas through a series direct human food ingredients is based of scrubbing towers. upon the following current good manu- (b) The Food and Drug Administra- facturing practice conditions of use: tion is developing food-grade specifica- (1) These ingredients are used as nu- tions for nitrous oxide in cooperation trient supplements as defined in with the National Academy of § 170.3(o)(20) of this chapter; as proc- Sciences. In the interim, the ingredient essing aids as defined in § 170.3(o)(24) of
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this chapter; and as surface-active cess glycerol to the fully hydrogenated agents as defined in § 170.3(o)(29) of this rapeseed oil and heating, in the pres- chapter. ence of a sodium hydroxide catalyst, to (2) These ingredients are used in food 330 °F under partial vacuum and steam at levels not to exceed current good sparging agitation. manufacturing practice. (2) The ingredient meets the speci- (d) Prior sanctions for these ingredi- fications of the ‘‘Food Chemicals ents different from the uses established Codex,’’ 3d Ed. (1981), p. 201, relating to in this section do not exist or have mono- and diglycerides, which is incor- been waived. porated by reference. Copies may be [49 FR 25430, June 21, 1984, as amended at 50 obtained from the National Academy FR 49536, Dec. 3, 1985] Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be exam- § 184.1555 Rapeseed oil. ined at the Office of the Federal Reg- (a) Fully hydrogenated rapeseed oil. (1) ister, 800 North Capitol Street, NW., Fully hydrogenated rapeseed oil is a suite 700, Washington, DC 20408. An ad- mixture of triglycerides in which the ditional specification requires the io- fatty acid composition is a mixture of dine number to be 4 or less. saturated fatty acids. The fatty acids (3) The ingredient is used as an emul- are present in the same porportions sifier as defined in § 170.3(o)(8) of this which result from the full hydro- chapter in shortenings for cake mixes. genation of fatty acids occurring in The use level of the ingredient is lim- natural rapeseed oil. The rapeseed oil ited by good manufacturing practice is obtained from the napus and (GMP) to the minimum amount re- campestris varieties of Brassica of the quired to produce the intended effect. family Cruciferae. It is prepared by Current good manufacturing practices fully hydrogenating refined and result in a maximum level, as served, bleached rapeseed oil at 310–375 °F, of 4 percent of the shortening or 0.5 using a catalyst such as nickel, until percent of the total weight of the cake the iodine number is 4 or less. mix. (2) The ingredient meets the fol- (c) Low erucic acid rapeseed oil. (1) lowing specifications: Acid value not Low erucic acid rapeseed oil, also more than 6, arsenic not more than 3 known as canola oil, is the fully re- parts per million, free glycerin not fined, bleached, and deodorized edible more than 7 percent, heavy metals (as oil obtained from certain varieties of Pb) not more than 10 parts per million, Brassica Napus or B. Campestris of the iodine number not more than 4, residue family Cruciferae. The plant varieties on ignition not more than 0.5 percent. are those producing oil-bearing seeds (3) The ingredient is used as a sta- with a low erucic acid content. Chemi- bilizer and thickener as defined in cally, low erucic acid rapeseed oil is a § 170.3(o)(28) of this chapter in peanut mixture of triglycerides, composed of butter. The use level of the ingredient both saturated and unsaturated fatty is limited by good manufacturing prac- acids, with an erucic acid content of no tice (GMP) to the minimum amount re- more than 2 percent of the component quired to produce the intended effect. fatty acids. Current good manufacturing practices (2) Low erucic acid rapeseed oil as de- result in a maximum level of 2 percent fined in paragraph (c)(1) of this section in peanut butter. may be partially hydrogenated to re- (b) Superglycerinated fully hydro- duce the proportion of unsaturated genated rapeseed oil. (1) fatty acids. When the partially hydro- Superglycerinated fully hydrogenated genated low erucic acid rapeseed oil is rapeseed oil is a mixture of mono- and used, it shall be referred to as partially diglycerides with triglycerides as a hydrogenated low erucic acid rapeseed minor component. The fatty acid com- oil. position is a mixture of saturated fatty (3) In addition to limiting the con- acids present in the same proportions tent of erucic acid to a level not ex- as those resulting from the full hydro- ceeding 2 percent of the component genation of fatty acids in natural fatty acids, FDA is developing other rapeseed oil. It is made by adding ex- food-grade specifications for low erucic
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acid rapeseed oil and partially hydro- cordance with § 170.30(h)(1) of this chap- genated low erucic acid rapeseed oil in ter. cooperation with the National Acad- (c) In accordance with § 184.1(b)(2), emy of Sciences. In the interim, the in- the ingredient is used to treat food gredients must be of a purity suitable only within the following specific limi- for their intended use. tations: (4) Low erucic acid rapeseed oil and partially hydrogenated low erucic acid Category of food Maximum treat- Functional use rapeseed oil are used as edible fats and ment level in food oils in food, except in infant formula, Bottled water that Not to exceed cur- Antimicrobial at levels not to exceed current good prior to ozonation rent good man- agent, ¤ 170.3 manufacturing practice. meets the micro- ufacturing prac- (o)(2) of this biological, phys- tice. Current chapter. [42 FR 48336, Sept. 23, 1977, as amended at 49 ical, chemical, good manufac- FR 5613, Feb. 14, 1984; 50 FR 3755, Jan. 28, and radiological turing practice 1985; 53 FR 52682, Dec. 29, 1988] quality standards results in a of ¤ 165.110 maximum resid- (b)(2) through ual level at the § 184.1560 Ox bile extract. (b)(5) of this time of bottling (a) Ox bile extract (CAS Reg. No. chapter. of 0.4 milligram of ozone per 8008–63–7), also known as purified liter of bottled oxgall or sodium choleate, is a yel- water. lowish green, soft solid, with a partly sweet, partly bitter, disagreeable taste. [47 FR 50210, Nov. 5, 1982, as amended at 60 It is the purified portion of the bile of FR 57130, Nov. 13, 1995] an ox obtained by evaporating the alco- hol extract of concentrated bile. § 184.1583 Pancreatin. (b) Food-grade ox bile extract shall meet the specifications of the U.S. (a) Pancreatin (CAS Reg. No. 8049–47– Pharmacopeia (USP), XIV, 1950, p. 410.1 6) is an enzyme preparation obtained (c) The ingredient is used as a surfac- from porcine or bovine pancreatic tis- tant as defined in § 170.3 (o)(29) of this sue. It is a white to tan powder. Its chapter. characterizing enzyme activity that of (d) The ingredient is used in food in a peptide hydrolase (EC 3.4.21.36). accordance with § 184.1(b)(1) at levels (b) The ingredient meets the general not to exceed good manufacturing requirements and additional require- practice. Current good manufacturing ments in the Food Chemicals Codex, 3d practice results in a maximum level, as ed. (1981), p. 110, which is incorporated served, of 0.002 percent for cheese as de- by reference in accordance with 5 fined in § 170.3(n)(5) of this chapter. U.S.C. 552(a) and 1 CFR part 51. Copies (e) Prior sanctions for this ingredient are available from the National Acad- different from the uses established in emy Press, 2101 Constitution Ave. NW., this section do not exist or have been Washington, DC 20418, or may be exam- waived. ined at the Office of Premarket Ap- proval (HFS–200), Food and Drug Ad- [43 FR 36064, Aug. 15, 1978. Redesignated and amended at 50 FR 49537, Dec. 3, 1985] ministration, 200 C St. SW., Wash- ington, DC, and the Office of the Fed- § 184.1563 Ozone. eral Register, 800 North Capitol St. NW., suite 700, Washington, DC. (a) Ozone (O3, CAS Reg. No. 10028–15– 6) is an unstable blue gas with a pun- (c) In accordance with § 184.1(b)(1), gent, characteristic odor, which occurs the ingredient is used in food with no freely in nature, It is produced com- limitation other than current good mercially by passing electrical dis- manufacturing practice. The affirma- charges or ionizing radiation through tion of this ingredient as GRAS as a di- air or oxygen. rect food ingredient is based upon the (b) The ingredient must be of a pu- following current good manufacturing rity suitable for its intended use in ac- practice conditions of use: (1) The ingredient is used as an en- 1 Copies may be obtained from: U.S. zyme as defined in § 170.3(o)(9) of this Pharmacopeial Convention, Inc., 12601 chapter to hydrolyze proteins or Twinbrook Parkway, Rockville, MD 20852. polypeptides.
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(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- nium, potassium, or sodium (CAS Reg. [60 FR 32911, June 26, 1995] No. 9000–59–8) salts, and in some types § 184.1585 Papain. as the acid amide. Thus, the pectins regulated in this section are the high- (a) Papain (CAS Reg. No. 9001–73–4) is ester pectins, low-ester pectins, a proteolytic enzyme derived from amidated pectins, pectinic acids, and Carica papaya L. Crude latex con- pectinates. Pectin is produced commer- taining the enzyme is collected from cially by extracting citrus peel, apple slashed unripe papaya. The food-grade pomace, or beet pulp with hot dilute product is obtained by repeated filtra- acid (pH 1.0 to 3.5, 70° to 90 °C). The ex- tion of the crude latex or an aqueous tract is filtered, and pectin is then pre- solution of latex or by precipitation cipitated from the clear extract with from an aqueous solution of latex. The ethanol or isopropanol, or as the cop- resulting enzyme preparation may be per or aluminum salt. The acid extract used in a liquid or dry form. is sometimes spray- or roller-dried, or (b) The ingredient meets the speci- it is concentrated to be sold as liquid fications of the Food Chemicals Codex, pectin. 3d Ed. (1981), pp. 107–110, which is incor- (b) The ingredients meet the speci- porated by reference. Copies are avail- fications of the Food Chemical Codex, able from the National Academy Press, 3d Ed. (1981), p. 215, 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)(1), Register 800 North Capitol Street, NW., the ingredient is used in food with no suite 700, Washington, DC 20408. limitation other than currect good (c) In accordance with § 184.1(b)(1), manufacturing practice. The affirma- the ingredients are used in food with tion of this ingredient as generally rec- no limitation other than current good ognized as safe (GRAS) as a direct manufacturing practice. The affirma- human food ingredient is based upon tion of these ingredients as generally the following current good manufac- recognized as safe (GRAS) as direct turing conditions of use: human food ingredients is based upon (1) The ingredient is used as an en- the following current good manufac- zyme as defined in § 170.3(o)(9) of this turing practice conditions of use: chapter; processing aid as defined in (1) The ingredients are used as emul- § 170.3(o)(24) of this chapter; and sifiers as defined in § 170.3(o)(8) of this texturizer as defined in § 170.3(o)(32) of chapter and as stabilizers and thick- this chapter. eners as defined in § 170.3(o)(28) of this (2) The ingredient is used in food at chapter. levels not to exceed current good man- (2) The ingredients are used in food ufacturing practice. at levels not to exceed current good (d) Prior sanctions for this ingredient manufacturing practice. different from the uses established in (d) Prior sanctions for these ingredi- this section do not exist or have been ents different from the uses established waived. in this section do not exist or have [48 FR 48806, Oct. 21, 1983] been waived. [48 FR 51149, Nov. 7, 1983] § 184.1588 Pectins. (a) The pectins (CAS Reg. No. 9000– § 184.1595 Pepsin. 69–5) are a group of complex, high mo- (a) Pepsin (CAS Reg. No. 9001–75–6) is lecular weight polysaccharides found an enzyme preparation obtained from in plants and composed chiefly of par- the glandular layer of hog stomach. It tially methylated polygalacturonic is a white to light tan powder, amber acid units. Portions of the carboxly paste, or clear amber to brown liquid.
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Its characterizing enzyme activity is Maximum level of that of a peptide hydrolase (EC use in 3.4.23.1). Category of food food (as Functional use served) (b) The ingredient meets the general (percent) requirements and additional require- ments for enzyme preparations in the Confections and 0.1 Stabilizer, thickener, frostings, ¤ 170.3(o)(28) of this Food Chemicals Codex, 3d ed. (1981), p. ¤ 170.3(n)(9) of this chapter 110, which is incorporated by reference chapter. in accordance with 5 U.S.C. 552(a) and 1 Gelatins and puddings, 0.7 Do. CFR part 51. Copies are available from ¤ 170.3(n)(22) of this chapter. the National Academy Press, 2101 Con- Processed fruits and 0.25 Do. stitution Ave. NW., Washington, DC fruit juices, 20418, or may be examined at the Office ¤ 170.3(n)(35) of this of Premarket Approval (HFS–200), Food chapter. All other food cat- 0.01 Do. and Drug Administration, 200 C St. egories. SW., Washington, DC, and the Office of the Federal Register, 800 North Capitol (d) Prior sanctions for potassium al- St. NW., suite 700, Washington, DC. ginate different from the uses estab- (c) In accordance with § 184.1(b)(1), lished in this section do not exist or the ingredient is used in food with no have been waived. limitation other than current good manufacturing practice. The affirma- [47 FR 29951, July 9, 1982] tion of this ingredient as GRAS as a di- § 184.1613 Potassium bicarbonate. rect food ingredient is based upon the following current good manufacturing (a) Potassium bicarbonate (KHCO3, practice conditions of use: CAS Reg. No. 298–14–6) is made by the (1) The ingredient is used as an en- following processes: zyme as defined in § 170.3(o)(9) of this (1) By treating a solution of potas- chapter to hydrolyze proteins or sium hydroxide with carbon dioxide; polypeptides. (2) By treating a solution of potas- (2) The ingredient is used in food at sium carbonate with carbon dioxide. levels not to exceed current good man- (b) The ingredient meets the speci- ufacturing practice. fications of the Food Chemicals Codex, 3d Ed. (1981), p. 239, which is incor- [60 FR 32911, June 26, 1995] porated by reference. Copies are avail- able from the National Academy Press, § 184.1610 Potassium alginate. 2101 Constitution Ave. NW., Wash- (a) Potassium alginate (CAS Reg. No. ington, DC 20418, or available for in- 9005–36–1) is the potassium salt of al- spection at the Office of the Federal ginic acid, a natural polyuronide con- Register, 800 North Capitol Street, stituent of certain brown algae. Potas- NW., suite 700, Washington, DC 20408. sium alginate is prepared by the neu- (c) In accordance with § 184.1(b)(1), tralization of purified alginic acid with the ingredient is used in food with no appropriate pH control agents. 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. 239, 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 formu- spection at the Office of the Federal lation aid as defined in § 170.3(o)(14) of Register, 800 North Capitol Street, this chapter; nutrient supplemlent as NW., suite 700, Washington, DC 20408. defined in § 170.3(o)(20) of this chapter; (c) In accordance with § 184.1(b)(2), pH control agent as defined in the ingredient is used in food only § 170.3(o)(23) of this chapter; and proc- within the following specific limita- essing aid as defined in § 170.3(o)(24) of tions: this chapter.
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(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 52442, Nov. 18, 1983] (d) Prior sanctions for this ingredient different from the uses established in § 184.1622 Potassium chloride. this section do not exist or have been waived. (a) Potassium chloride (KCl, CAS Reg. No. 7447–40–7) is a white, odorless [48 FR 52442, Nov. 18, 1983] solid prepared from source minerals by fractional crystallization or flotation. § 184.1619 Potassium carbonate. It is soluble in water and glycerol and (a) Potassium carbonate (K2CO3, CAS has a saline taste at low concentration Reg. No. 584–08–7) is produced by the levels. following methods of manufacture: (b) The ingredient meets the speci- (1) By electrolysis of potassium chlo- fications of the Food Chemicals Codex, ride followed by exposing the resultant 3d Ed. (1981), p. 241, which is incor- potassium to carbon dioxide; porated by reference. Copies are avail- (2) By treating a solution of potas- able from the National Academy Press, sium hydroxide with excess carbon di- 2101 Constitution Ave. NW., Wash- oxide to produce potassium carbonate; ington, DC 20418, or available for in- (3) By treating a solution of potas- spection at the Office of the Federal sium hydroxide with carbon dioxide to Register, 800 North Capitol Street, produce potassium bicarbonate, which NW., suite 700, Washington, DC 20408. is then heated to yield potassium car- (c) In accordance with § 184.1(b)(1), bonate. the ingredient is used in food with no (b) The ingredient meets the speci- limitation other than current good fications of the Food Chemicals Codex, manufacturing practice. The affirma- 3d Ed. (1981), p. 240, which is incor- tion of this ingredient as generally rec- porated by reference. Copies are avail- ognized as safe (GRAS) as a direct able from the National Academy Press, human food ingredient is based upon 2101 Constitution Ave. NW., Wash- the following current good manufac- ington, D.C. 20418, or available for in- turing practice conditions of use: spection at the Office of the Federal (1) The ingredient is used as a flavor Register, 800 North Capitol Street, enhancer as defined in § 170.3(o)(11) of NW., suite 700, Washington, DC 20408. this chapter; as a flavoring agent as de- (c) In accordance with § 184.1(b)(1), fined in § 170.3(o)(12) of this chapter; as the ingredient is used in food with no a nutrient supplement as defined in limitation other than current good § 170.3(o)(20) of this chapter; as a pH manufacturing practice. the affirma- control agent as defined in §170.3(o)(23) tion of this ingredient as generally rec- of this chapter; and as a stabilizer or ognized as safe (GRAS) as a direct human food ingredient is based upon thickener as defined in § 170.3(o)(28) of the following current good manufac- this chapter. turing practice conditions of use: (2) The ingredient is used in food at (1) The ingredient is used in food as a levels not to exceed current good man- flavoring agent and adjuvant as defined ufacturing practice. Potassium chlo- in § 170.3(o)(12) of this chapter; nutrient ride may be used in infant formula in supplement as defined in § 170.3(o)(20) of accordance with section 412(g) of the this chapter; pH control agent as de- Federal Food, Drug, and Cosmetic Act fined in § 170.3(o)(23) of this chapter; (the Act) or with regulations promul- and processing aid as defined in gated under section 412(a)(2) of the Act. § 170.3(o)(24) of this chapter. (d) Prior sanctions for this ingredient (2) The ingredient is used in food at different from the uses established in levels not to exceed current good man- this section do not exist or have been ufacturing practice. waived. (d) Prior sanctions for this ingredient [48 FR 51614, Nov. 10, 1983] different from the uses established in
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§ 184.1625 Potassium citrate. North Capitol Street, NW., suite 700, Washington, DC 20408. (a) Potassium citrate (C6H5K3O7·H2O, CAS Reg. No. 006100–0905–096) is the po- (c) In accordance with § 184.1(b)(1), tassium salt of citric acid. It is pre- the ingredient is used in food with no pared by neutralizing citric acid with limitation other than current good potassium hydroxide or potassium car- manufacturing practice. The affirma- bonate. It occurs as transparent crys- tion of this ingredient as generally rec- tals or a white granular powder, is ognized as safe (GRAS) as a direct odorless and deliquescent, and contains human food ingredient is based upon one mole of water per mole of potas- the following current good manufac- sium citrate. turing practice conditions of use: (b) The ingredient meets the speci- (1) The ingredient is used as a formu- fications of the Food Chemicals Codex, lation aid as defined in § 170.3(o)(14) of 3d ed. (1981), p. 242, which is incor- this chapter; a pH control agent as de- porated by reference in accordance fined in § 170.3(o)(23) of the chapter; a with 5 U.S.C. 552(a) and 1 CFR part 51. processing aid as defined in § 170.3(o)(24) Copies are available from the National of this chapter; and a stabilizer and Academy Press, 2101 Constitution Ave. thickener as defined in § 170.3(o)(28) of NW., Washington, DC 20418, and the this chapter. Center for Food Safety and Applied Nu- (2) The ingredient is used in food at trition (HFS–200), 200 C St. SW., Wash- levels not to exceed current good man- ington, DC 20204, or may be examined ufacturing practice. at the Office of the Federal Register, (d) Prior sanctions for this ingredient 800 North Capitol St. NW., suite 700, different from the uses established in Washington, DC. 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 limitation other than current good [48 FR 52444, Nov. 18, 1983] manufacturing practice. § 184.1634 Potassium iodide. (d) Prior sanctions for this ingredient different from the uses established in (a) Potassium iodide (KI, CAS Reg. this section, or different from those set No. 7681–11–0) is the potassium salt of forth in part 181 of this chapter, do not hydriodic acid. It occurs naturally in exist or have been waived. sea water and in salt deposits, but can be prepared by reacting hydriodic acid [59 FR 63896, Dec. 12, 1994] (HI) with potassium bicarbonate § 184.1631 Potassium hydroxide. (KHCO3). (b) The ingredient meets the speci- (a) Potassium hydroxide (KOH, CAS fications of the ‘‘Food Chemicals Reg. No. 1310–58–3) is also known as Codex,’’ 3d Ed. (1981), pp. 246–247, which caustic potash, potash lye, and potassa. is incorporated by reference. Copies The empirical formula is KOH. It is a may be obtained from the National white, highly deliquescent caustic Academy Press, 2101 Constitution Ave. solid, which is marketed in several NW., Washington, DC 20418, or may be forms, including pellets, flakes, sticks, examined at the Office of the Federal lumps, and powders. Potassium hydrox- ide is obtained commercially from the Register, 800 North Capitol Street, electrolysis of potassium chloride solu- NW., suite 700, Washington, DC 20408. tion in the presence of a porous dia- (c) The ingredient is used as a nutri- phragm. ent supplement as defined in (b) The ingredient meets the speci- § 170.3(o)(20) of this chapter. fications of the Food Chemicals Codex, (d) The ingredient is used in table 3d Ed. (1981), which is incorporated by salt in accordance with § 184.1(b)(2) of reference. Copies are available from this chapter as a source of dietary io- the National Academy Press, 2101 Con- dine at a maximum level of 0.01 per- stitution Ave. NW., Washington, DC cent. 20418, or available from inspection at (e) Prior sanctions for this ingredient the Office of the Federal Register, 800 different from the uses established in
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this section do not exist or have been upon the following current good manu- waived. facturing practice conditions of use: [43 FR 11699, Mar. 21, 1978, as amended at 49 (1) The ingredient is used as a flavor FR 5613, Feb. 14, 1984; 61 FR 14247, Apr. 1, enhancer as defined in § 170.3(o)(11) of 1996] this chapter; a flavoring agent or adju- vant as defined in § 170.3(o)(12) of this § 184.1635 Potassium iodate. chapter; a humectant as defined in (a) Potassium iodate (KIO3, CAS Reg. § 170.3(o)(16) of this chapter; and a pH No. 7758–05–6) does not occur naturally control agent as defined in § 170.3(o)(23) but can be prepared by reacting iodine of this chapter. with potassium hydroxide. (2) The ingredient is used in food at (b) The ingredient meets the speci- levels not to exceed current good man- fications of the ‘‘Food Chemicals ufacturing practice. Codex,’’ 3d Ed. (1981), pp. 245–246, which (d) Prior sanctions for this ingredient is incorporated by reference. Copies different from the uses established in may be obtained from the National this section do not exist or have been Academy Press, 2101 Constitution Ave. waived. NW., Washington, DC 20418, or may be examined at the Office of the Federal [52 FR 10886, Apr. 6, 1987] Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. § 184.1643 Potassium sulfate.
(c) The ingredient is used as a dough (a) Potassium sulfate (K2SO4, CAS strengthener as defined in § 170.3(o)(6) Reg. No. 7778–80–5) occurs naturally and of this chapter. consists of colorless or white crystals (d) The ingredient is used in the man- or crystalline powder having a bitter, ufacture of bread in accordance with saline taste. It is prepared by the neu- § 184.1(b)(2) of this chapter in an tralization of sulfuric acid with potas- amount not to exceed 0.0075 percent sium hydroxide or potassium car- based on the weight of the flour. bonate. (e) Prior sanctions for this ingredient 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. 252, which is in- corporated by reference. Copies may be [43 FR 11699, Mar. 21, 1978, as amended at 49 obtained from the National Academy FR 5613, Feb. 14, 1984] Press, 2101 Constitution Ave. NW., § 184.1639 Potassium lactate. Washington, DC 20418, or may be exam- ined at the Office of the Federal Reg- H O K, CAS (a) Potassium lactate (C3 5 3 ister, 800 North Capitol Street, NW., Reg. No. 996–31–6) is the potassium salt suite 700, Washington, DC 20408. of lactic acid. It is a hydroscopic, white, odorless solid and is prepared (c) The ingredient is used as a fla- commercially by the neutralization of voring agent and adjuvant as defined in lactic acid with potassium hydroxide. § 170.3(o)(12) of this chapter. (b) FDA is developing food-grade (d) The ingredient is used in food at specifications for potassium lactate in levels not to exceed good manufac- cooperation with the National Acad- turing practice in accordance with emy of Sciences. In the interim, this § 184.1(b)(1). Current good manufac- ingredient must be of a purity suitable turing practice results in a maximum for its intended use. level, as served, of 0.015 percent for (c) In accordance with § 184.1(b)(1), nonalcoholic beverages as defined in the ingredient is used in food with no § 170.3(n)(3) of this chapter. limitation other than current good (e) Prior sanctions for this ingredient manufacturing practice. This regula- different from the uses established in tion does not authorize its use in in- this section do not exist or have been fant foods and infant formulas. The af- waived. firmation of this ingredient as gen- erally recognized as safe (GRAS) as a [45 FR 6086, Jan. 25, 1980, as amended at 49 direct human food ingredient is based FR 5613, Feb. 14, 1984]
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§ 184.1655 Propane. Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (a) Propane (empirical formula C3H8, (c) The ingredient is used as an anti- CAS Reg. No. 74–98–6) is also known as oxidant as defined in § 170.3(o)(3) of this dimethylmethane or propyl hydrid. It chapter. is a colorless, odorless, flammable gas (d) The ingredient is used in food at at normal temperatures and pressures. levels not to exceed good manufac- It is easily liquefied under pressure at turing practice in accordance with room temperature and is stored and § 184.1(b)(1). Good manufacturing prac- shipped in the liquid state. Propane is tice results in a maximum total con- obtained from natural gas by fraction- tent of antioxidants of 0.02 percent of ation following absorption in oil, ad- the fat or oil content, including the es- sorption to surface-active agents, or re- sential (volatile) oil content, of the frigeration. food. (b) The Food and Drug Administra- (e) Prior sanctions for this ingredient tion is developing food-grade specifica- different from the uses established in tions for propane in cooperation with this section, or different from that the National Academy of Sciences. In stated in part 181 of this chapter, do the interim, the ingredient must be of not exist or have been waived. a purity suitable for its intended use. [42 FR 14653, Mar. 15, 1977, as amended at 44 (c) In accordance with § 184.1(b)(1), FR 52826, Sept. 11, 1979; 49 FR 5613, Feb. 14, the ingredient is used in food with no 1984] limitations other than current good manufacturing practice. The affirma- § 184.1666 Propylene glycol.
tion of this ingredient as generally rec- (a) Propylene glycol (C3H8O2, CAS ognized as safe (GRAS) as a direct Reg. No. 57–55–6) is known as 1,2- human food ingredient is based upon propanediol. It does not occur in na- the following current good manufac- ture. Propylene glycol is manufactured turing practice conditions of use: by treating propylene with chlorinated (1) The ingredient is used as a propel- water to form the chlorohydrin which lant, aerating agent, and gas as defined is converted to the glycol by treatment in § 170.3(o)(25) of this chapter. with sodium carbonate solution. It is (2) The ingredient is used in food at also prepared by heating glyercol with levels not to exceed current good man- sodium hydroxide. ufacturing 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. 255, which is incor- this section do not exist or have been porated by reference. Copies may be waived. obtained from the National Academy Press, 2101 Constitution Ave. NW., [48 FR 57271, Dec. 29, 1983] Washington, DC 20418. It is also avail- able for inspection at the Office of the § 184.1660 Propyl gallate. Federal Register, 800 North Capitol (a) Propyl gallate is the n- Street, NW., suite 700, Washington, DC propylester of 3,4,5-trihydroxybenzoic 20408. acid (C10H12O5). Natural occurrence of (c) The ingredient is used as an propyl gallate has not been reported. It anticaking agent as defined in is commercially prepared by § 170.3(o)(1) of this chapter; antioxidant esterification of gallic acid with propyl as defined in § 170.3(o)(3) of this chap- alcohol followed by distillation to re- ter; dough strengthener as defined in move excess alcohol. § 170.3(o)(6) of this chapter; emulsifier (b) The ingredient meets the speci- as defined in § 170.3(o)(8) of this chap- fications of the ‘‘Food Chemicals ter; flavor agent as defined in Codex,’’ 3d Ed. (1981), pp. 257–258, which § 170.3(o)(12) of this chapter; formula- is incorporated by reference. Copies tion aid as defined in § 170.3(o)(14) of may be obtained from the National this chapter; humectant as defined in Academy Press, 2101 Constitution Ave. § 170.3(o)(16) of this chapter; processing NW., Washington, DC 20418, or may be aid as defined in § 170.3(o)(24) of this examined at the Office of the Federal chapter; solvent and vehicle as defined
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in § 170.3(o)(27) of this chapter; sta- this regulation do not exist or have bilizer and thickener as defined in been waived. § 170.3(o)(28) of this chapter; surface-ac- [42 FR 14653, Mar. 15, 1977, as amended at 49 tive agent as defined in § 170.3(o)(29) of FR 5613, Feb. 14, 1984] this chapter; and texturizer as defined in § 170.3(o)(32) of this chapter. § 184.1676 Pyridoxine hydrochloride. (d) The ingredient is used in foods at (a) Pyridoxine hydrochloride levels not to exceed current good man- (C8H11NO3·HCl, CAS Reg. No. 58–56–0) is ufacturing practice in accordance with the chemical 3-hydroxy–4,5- § 184.1(b)(1). Current good manufac- dihydroxymethy–2-methylpyridine hy- turing practice results in maximum drochloride that is prepared by chem- levels, as served, of 5 percent for alco- ical synthesis. holic beverages, as defined in (b) The ingredient meets the speci- § 170.3(n)(2) of this chapter; 24 percent fications of the Food Chemicals Codex, for confections and frostings as defined 3d Ed. (1981), p. 260, which is incor- in § 170.3(n)(9) of this chapter; 2.5 per- porated by reference. Copies are avail- cent for frozen dairy products as de- able from the National Academy Press, fined in § 170.3(n)(20) of this chapter; 97 2101 Constitution Ave. NW., Wash- percent for seasonings and flavorings ington, DC 20418, or available for in- as defined in § 170.3(n)(26) of this chap- spection at the Office of the Federal ter; 5 percent for nuts and nut products Register, 800 North Capitol Street, as defined in § 170.3(n)(32) of this chap- NW., suite 700, Washington, DC 20408. ter; and 2.0 percent for all other food (c) In accordance with § 184.1(b)(1), categories. the ingredient is used in food with no (e) Prior sanctions for this ingredient limitation other than current good 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 [47 FR 27812, June 25, 1982] the following current good manufac- turing practice conditions of use: § 184.1670 Propylparaben. (1) The ingredient is used as a nutri- (a) Propylparaben is the chemical ent supplement as defined in propyl p-hydroxybenzoate. It is pro- § 170.3(o)(20) of this chapter. duced by the n-propanol esterification (2) The ingredient is used in the fol- of p-hydroxybenzoic acid in the pres- lowing foods at levels not to exceed ence of sulfuric acid, with subsequent current good manufacturing practice: distillation. baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic beverages (b) The ingredient meets the speci- and beverage bases as defined in fications of the ‘‘Food Chemicals § 170.3(n)(3) of this chapter; breakfast Codex,’’ 3d Ed. (1981), p. 258, which is in- cereals as defined in § 170.3(n)(4) of this corporated by reference. Copies may be chapter; dairy product analogs as de- obtained from the National Academy fined in § 170.3(n)(10) of this chapter; Press, 2101 Constitution Ave. NW., meat products as defined in Washington, DC 20418, or may be exam- § 170.3(n)(29) of this chapter; milk prod- ined at the Office of the Federal Reg- ucts as defined in § 170.3(n)(31) of this ister, 800 North Capitol Street, NW., chapter; plant protein products as de- suite 700, Washington, DC 20408. fined in § 170.3(n)(33) of this chapter; (c) The ingredient is used as an anti- and snack foods as defined in microbial agent as defined in § 170.3(n)(37) of this chapter. Pyridoxine § 170.3(o)(2) of this chapter. hydrochloride may be used in infant (d) The ingredient is used in food at formula in accordance with section levels not to exceed good manufac- 412(g) of the Federal Food, Drug, and turing practices. Current good manu- Cosmetic Act (the Act) or with regula- facturing practice results in a max- tions promulgated under section imum level of 0.1 percent in food. 412(a)(2) of the Act. (e) Prior sanctions for this ingredient (d) Prior sanctions for this ingredient different from the uses established in different from the uses established in
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this section do not exist or have been gillus niger van Tieghem variety waived. awamori (Nakazawa) Al-Musallam (syn- [48 FR 51615, Nov. 10, 1983] onym A. awamori Nakazawa) con- taining the prochymosin gene. § 184.1685 Rennet (animal-derived) Chymosin is recovered from the fer- and chymosin preparation (fer- mentation broth after acid treatment. mentation-derived). All materials used in the processing (a)(1) Rennet and bovine rennet are and formulating of chymosin prepara- commercial extracts containing the ac- tion must be either generally recog- tive enzyme rennin (CAS Reg. No. 9001– nized as safe (GRAS) or be food addi- 98–3), also known as chymosin (Inter- tives that have been approved by the national Union of Biochemistry En- Food and Drug Administration for this zyme Commission (E.C.) 3.4.23.4). use. Rennet is the aqueous extract prepared (b) Rennet and chymosin preparation from cleaned, frozen, salted, or dried meet the general and additional re- fourth stomachs (abomasa) of calves, quirements for enzyme preparations of kids, or lambs. Bovine rennet is the the ‘‘Food Chemicals Codex,’’ 3d Ed. product from adults of the animals list- (1981), pp. 107–110, which is incorporated ed above. Both products are called by reference in accordance with 5 rennet and are clear amber to dark U.S.C. 552(a). Copies are available from brown liquid preparations or white to the National Academy Press, 2101 Con- tan powders. stitution Avenue NW., Washington, DC (2) Chymosin preparation is a clear 20418, or are available for inspection at solution containing the active enzyme the Office of the Federal Register, 800 chymosin (E.C. 3.4.23.4). It is derived, North Capitol Street, NW., suite 700, via fermentation, from a nonpatho- Washington, DC. genic and nontoxigenic strain of Esch- (c) In accordance with § 184.1(b)(1), erichia coli K–12 containing the the ingredient is used in food with no prochymosin gene. The prochymosin is limitation other than current good isolated as an insoluble aggregate that manufacturing practice. The affirma- is acid-treated to destroy residual cel- tion of this ingredient as generally rec- lular material and, after solubilization, ognized as safe as a direct human food is acid-treated to form chymosin. It ingredient is based upon the following must be processed with materials that current good manufacturing practice are generally recognized as safe, or are conditions of use: food additives that have been approved (1) The ingredient is used as an en- by the Food and Drug Administration zyme as defined in § 170.3(o)(9) of this for this use. chapter; a processing aid as defined in (3) Chymosin preparation is a clear § 170.3(o)(24) of this chapter; and a sta- solution containing the active enzyme bilizer and thickener as defined in chymosin (E.C. 3.4.23.4). It is derived, § 170.3(o)(28) of this chapter. via fermentation, from a nonpatho- genic and nontoxigenic strain of (2) The ingredient is used in the fol- Kluyveromyces marxianus variety lactis, lowing foods at levels not to exceed containing the prochymosin gene. The current good manufacturing practice: prochymosin is secreted by cells into In cheeses as defined in § 170.3(n)(5) of fermentation broth and converted to this chapter; frozen dairy desserts and chymosin by acid treatment. All mate- mixes as defined in § 170.3(n)(20) of this rials used in the processing and formu- chapter; gelatins, puddings, and fillings lating of chymosin must be either gen- as defined in § 170.3(n)(22) of this chap- erally recognized as safe (GRAS), or be ter; and milk products as defined in food additives that have been approved § 170.3(n)(31) of this chapter. by the Food and Drug Administration (d) Prior sanctions for this ingredient for this use. different from the uses established in (4) Chymosin preparation is a clear this section do not exist or have been solution containing the active enzyme waived. chymosin (E.C. 3.4.23.4). It is derived, [55 FR 10935, Mar. 23, 1990, as amended at 57 via fermentation, from a nonpatho- FR 6479, Feb. 25, 1992; 58 FR 27202, May 7, genic and nontoxigenic strain of Asper- 1993]
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§ 184.1695 Riboflavin. porated by reference. Copies are avail- able from the National Academy Press, (a) Riboflavin (C H N O CAS Reg. 17 20 4 6, 2101 Constitution Ave. NW., Wash- No. 83–88–5) occurs as yellow to orange- ington DC 20418, or available for inspec- yellow needles that are crystallized tion at the Office of the Federal Reg- from 2N acetic acid, alcohol, water, or ister, 800 North Capitol Street, NW., pyridine. It may be prepared by chem- suite 700, Washington, DC 20408. ical synthesis, biosynthetically by the (c) In accordance with § 184.1(b)(1), organism Eremothecium ashbyii, or iso- the ingredient is used in food with no lated from natural sources. 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. 262, 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 nutri- spection at the Office of the Federal ent supplement as defined in Register, 800 North Capitol Street, § 170.3(o)(20) of this chapter. NW., suite 700, Washington, DC 20408. (2) The ingredient is used in milk (c) In accordance with § 184.1(b)(1), products, as defined in § 170.3(n)(31) of the ingredient is used in food with no this chapter, at levels not to exceed limitation other than current good current good manufacturing practice. manufacturing practice. The affirma- The ingredient may also be used in in- tion of this ingredient as generally rec- fant formulas in accordance with sec- ognized as safe (GRAS) as a direct tion 412(g) of the Federal Food, Drug, human food ingredient is based upon and Cosmetic Act (the Act) or with reg- the following current good manufac- ulations promulgated under section turing practice conditions of use: 412(a)(2) of the Act. (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. this section do not exist or have been (2) The ingredient is used in foods at waived. levels not to exceed current good man- ufacturing practice. The ingredient [48 FR 51148, Nov. 7, 1983] may also be used in infant formula in accordance with section 412(g) of the § 184.1698 Rue. Federal Food, Drug, and Cosmetic Act (a) Rue is the perennial herb of sev- (the Act) or with regulations promul- eral species of Ruta (Ruta montana L., gated under section 412(a)(2) of the Act. Ruta graveolens L., Ruta bracteosa L., (d) Prior sanctions for this ingredient and Ruta calepensis L.). The leaves, different from the uses established in buds, and stems from the top of the this section do not exist or have been plant are gathered, dried, and then waived. crushed in preparation for use, or left whole. [48 FR 51148, Nov. 7, 1983] (b) The ingredient is used in all cat- § 184.1697 Riboflavin–5′-phosphate (so- egories of food in accordance with dium). § 184.1(b)(2) of this chapter at con- centrations not to exceed 2 parts per (a) Riboflavin-5′-phosphate (sodium) million. (C H N O PNa·2H O, CAS Reg. No 130– 17 20 4 9 2 (c) Prior sanctions for this ingredient 40–5) occurs as the dihydrate in yellow different from the uses established in to orange-yellow crystals. It is pre- this section do not exist or have been pared by phosphorylation of riboflavin waived. with chlorophosphoric acid, pyrophosphoric acid, metaphosphoric [43 FR 3705, Jan. 27, 1978] acid, or pyrocatechol cyclic phosphate. (b) The ingredient meets the speci- § 184.1699 Oil of rue. fications of the Food Chemicals Codex, (a) Oil of rue is the natural substance 3d Ed. (1981), p. 263, which is incor- obtained by steam distillation of the
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fresh blossoming plants of rue, the pe- Ave. NW., Washington, DC 20055 (Inter- rennial herb of several species of net address ‘‘http://www.nap.edu’’), or Ruta—Ruta montana L., Ruta graveolens may be examined at the Center for L., Ruta bracteosa L., and Ruta Food Safety and Applied Nutrition’s calepensis L. Library, Food and Drug Administra- (b) Oil of rue meets the specifications tion, 200 C St. SW., rm. 3321, Wash- of the ‘‘Food Chemicals Codex,’’ 4th ed. ington, DC, or at the Office of the Fed- (1996), pp. 342–343, which is incorporated eral Register, 800 North Capitol St. by reference in accordance with 5 NW., suite 700, Washington, DC. U.S.C. 552(a) and 1 CFR part 51. Copies (c) The ingredient is used in food are available from the National Acad- emy Press, Box 285, 2101 Constitution 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 current good manufacturing practice, different from the uses established in except that the ingredient may not be this section do not exist or have been used in a standardized food unless per- waived. mitted by the standard of identity: Confections and frostings as defined in [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984; 64 FR 1760, Jan. 12, § 170.3(n)(9) of this chapter, coatings of 1999] soft candy as defined in § 170.3(n)(38) of this chapter, and sweet sauces and top- § 184.1702 Sheanut oil. pings as defined in § 170.3(n)(43) of this (a) Sheanut oil is produced from chapter. sheanuts derived from the Shea tree [63 FR 28895, May 27, 1998] Butyrospermum parkii and is composed principally of triglycerides containing § 184.1721 Sodium acetate.
an oleic acid moiety at the 2-position (a) Sodium acetate (C2H3O2Na, CAS and saturated fatty acids, usually ste- Reg. No. 127–09–3 or C2H3O2Na·3H2O, aric or palmitic acids, at the 1- and 3- CAS Reg. No. 6131–90–4) is the sodium positions. salt of acetic acid and occurs naturally (b) The ingredient meets the fol- in plant and animal tissues. Sodium ac- lowing specifications when tested using etate may occur in either the anhy- any appropriate validated method- drous or trihydrated form. It is pro- ology: duced synthetically by the neutraliza- (1) Saponification value of 185 to 195, tion of acetic acid with sodium car- (2) Iodine value of 28 to 43, bonate or by treating calcium acetate (3) Unsaponifiable matter not to ex- with sodium sulfate and sodium bicar- ceed 1.5 percent, bonate. (4) Free fatty acids not more than 0.1 (b) The ingredient meets the speci- percent as oleic acid, fications of the Food Chemicals Codex, (5) Peroxide value not more than 10 3d Ed. (1981), pp. 272, 273 which is incor- milliequivalents/equivalent (meq/eq), porated by reference. Copies are avail- (6) Lead not more than 0.1 part per able from the National Academy Press, million (ppm), 2101 Constitution Ave. NW., Wash- (7) Copper not more than 0.1 ppm. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(3), spection at the Office of the Federal the ingredient is used in the following Register, 800 North Capitol Street, food categories at levels not to exceed NW., suite 700, Washington, DC 20408.
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(c) The ingredient is used as a fla- (e) Prior sanctions for this ingredient voring agent and adjuvant as defined in different from the uses established in § 170.3(o)(12) of this chapter; and as a pH this section do not exist or have been control agent as defined in § 170.3(o)(23) waived. of this chapter. (d) The ingredient is used in food at [47 FR 27815, June 25, 1982] levels not to exceed current good man- § 184.1724 Sodium alginate. ufacturing practice in accordance with 184.1(b)(1). Current good manufacturing (a) Sodium alginate (CAS Reg. No. practice results in a maximum level, as 9005–38–3) is the sodium salt of alginic served, of 0.007 percent for breakfast acid, a natural polyuronide constituent cereals as defined in § 170.3(n)(4) of this of certain brown algae. Sodium algi- chapter; 0.5 percent for fats and oils as nate is prepared by the neutralization defined in § 170.3(n)(12) of this chapter; of purified alginic acid with appro- 0.6 percent for grain products and pas- priate pH control agents. tas as defined in § 170.3(n)(23) of this (b) The ingredient meets the speci- chapter and snack foods as defined in fications of the Food Chemicals Codex, § 170.3(n)(37) of this chapter; 0.15 per- 3d Ed. (1981), p. 274, which is incor- cent for hard candy as defined in porated by reference. Copies are avail- § 170.3(n)(25) of this chapter; 0.12 per- able from the National Academy Press, cent for jams and jellies as defined in 2101 Constitution Ave. NW., Wash- § 170.3(n)(28) of this chapter and meat ington, DC 20418, or available for in- products as defined in § 170.3(n)(29) of spection at the Office of the Federal this chapter; 0.2 percent for soft candy Register, 800 North Capitol Street, as defined in § 170.3(n)(38) of this chap- NW., suite 700, Washington, DC 20408. ter; 0.05 percent for soups and soup (c) In accordance with § 184.1(b)(2), mixes as defined in § 170.3(n)(40) of this the ingredient is used in food only chapter and sweet sauces as defined in within the following specific limita- § 170.3(n)(43) of this chapter. tions:
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 adju- vant, ¤ 170.3(o)(12) of this chapter; stabilizer, thick- ener, ¤ 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- § 184.1733 Sodium benzoate. nate different from the uses established (a) Sodium benzoate is the chemical in this section do not exist or have benzoate of soda (C H NaO ), produced been waived. 7 5 2 by the neutralization of benzoic acid [47 FR 29951, July 9, 1982, as amended at 48 with sodium bicarbonate, sodium car- FR 52448, Nov. 18, 1983] bonate, or sodium hydroxide. The salt is not found to occur naturally.
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(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. 278, which is in- [48 FR 52442, Nov. 18, 1983] corporated by reference. Copies may be obtained from the National Academy § 184.1742 Sodium carbonate. Press, 2101 Constitution Ave. NW., (a) Sodium carbonate (Na2CO3, CAS Washington, DC 20418, or may be exam- Reg. No. 497–19–8) is produced (1) from ined at the Office of the Federal Reg- purified trona ore that has been ister, 800 North Capitol Street, NW., calcined to soda ash; (2) from trona ore suite 700, Washington, DC 20408. calcined to impure soda ash and then (c) The ingredient is used as an anti- purified; or (3) synthesized from lime- microbial agent as defined in stone by the Solvay process. § 170.3(o)(2) of this chapter, and as a fla- (b) The ingredient meets the speci- voring agent and adjuvant as defined in fications of the Food Chemicals Codex, § 170.3(o)(12) of this chapter. 3d Ed. (1981), p. 280, 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. Current usage results 2101 Constitution Ave. NW., Wash- in a maximum level of 0.1 percent in ington, DC 20418, or available for in- food. (The Food and Drug Administra- spection at the Office of the Federal tion has not determined whether Register, 800 North Capitol Street, significally different conditions of use NW., suite 700, Washington, DC 20408. would be GRAS.) (c) In accordance with § 184.1(b)(1), (e) 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 that set manufacturing practice. The affirma- forth in part 181 of this chapter, do not tion of this ingredient as generally rec- exist or have been waived. ognized as safe (GRAS) as a direct human food ingredient is based upon [42 FR 14653, Mar. 15, 1977, as amended at 49 the following current good manufac- FR 5613, Feb. 14, 1984] turing practice conditions of use: (1) The ingredient is used in food as § 184.1736 Sodium bicarbonate. an antioxidant as defined in § 170.3(o)(3) (a) Sodium bicarbonate (NaHCO3, of this chapter; curing and pickling CAS Reg. No. 144–55–8) is prepared by agent as defined in § 170.3(o)(5) of this treating a sodium carbonate or a so- chapter; flavoring agent and adjuvant dium carbonate and sodium bicarbon- as defined in § 170.3(o)(12) of this chap- ate solution with carbon dioxide. As ter; pH control agent as defined in carbon dioxide is absorbed, a suspen- § 170.3(o)(23) of this chapter; and proc- sion of sodium bicarbonate forms. The essing aid as defined in § 170.3(o)(24) of slurry is filtered, forming a cake which this chapter. is washed and dried. (2) The ingredient is used in food at (b) The ingredient meets the speci- levels not to exceed current good man- fications of the Food Chemicals Codex, ufacturing practice. 3d Ed. (1981), p. 278, 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 Ave. NW., Wash- waived. ington, DC 20418, or available for in- [48 FR 52442, Nov. 18, 1983, as amended at 50 spection at the Office of the Federal FR 49536, Dec. 3, 1985] Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. § 184.1751 Sodium citrate.
(c) In accordance with § 184.1(b)(1), (a) Sodium citrate (C6H5Na3O7·2H2O, the ingredient is used in food with no CAS Reg. No. 68–0904–092) is the sodium limitation other than current good salt of citric acid. It is prepared by manufacturing practice. neutralizing citric acid with sodium (d) Prior sanctions for this ingredient hydroxide or sodium carbonate. The different from the uses established in product occurs as colorless crystals or
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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 (b) The ingredient meets the speci- chapter; 0.1 percent for fats and oils as fications of the Food Chemicals Codex, defined in § 170.3(n)(12) of this chapter, 3d ed. (1981), pp. 283–284, which is incor- meat products as defined in porated by reference in accordance § 170.3(n)(29) of this chapter and soft with 5 U.S.C. 552(a) and 1 CFR part 51. candy as defined in § 170.3(n)(38) of this Copies are available from the National chapter; 0.25 percent for gravies and Academy Press, 2101 Constitution Ave. sauces as defined in § 170.3(n)(24) of this NW., Washington, DC 20418, and the chapter; and 0.05 percent for snack Center for Food Safety and Applied Nu- foods as defined in § 170.3(n)(37) of this trition (HFS–200), 200 C St. SW., Wash- chapter and soups and soup mixes as ington, DC 20204, or may be examined defined in § 170.3(n)(40) of this chapter. at the Office of the Federal Register, (e) Prior sanctions for this ingredient 800 North Capitol St. NW., suite 700, different from the uses established in Washington, DC. 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 limitation other than current good [47 FR 27815, June 25, 1982] manufacturing practice. (d) Prior sanctions for this ingredient § 184.1763 Sodium hydroxide. different from the uses established in (a) Sodium hydroxide (NaOH, CAS this section, or different from those set Reg. No. 1310–73–2) is also known as so- forth in part 181 of this chapter, do not dium hydrate, soda lye, caustic soda, exist or have been waived. white caustic, and lye. The empirical [59 FR 63896, Dec. 12, 1994] formula is NaOH. Sodium hydroxide is prepared commercially by the elec- § 184.1754 Sodium diacetate. trolysis of sodium chloride solution and also by reacting calcium hydroxide (a) Sodium diacetate (C4H7O4Na·xH2O, CAS Reg. No. 126–96–5) is a molecular with sodium carbonate. compound of acetic acid, sodium ace- (b) The ingredient meets the speci- tate, and water of hydration. The tech- fications of the Food Chemicals Codex, nical grade is prepared synthetically 3d Ed. (1981), which is incorporated by by reacting sodium carbonate with ace- reference. Copies are available from tic acid. Special grades are produced by the National Academy Press, 2101 Con- reacting anhydrous sodium acetate and stitution Ave. NW., Washington, DC acetic acid. 20418, or available for inspection at the (b) The ingredient meets the speci- Office of the Federal Register, 800 fications of the Food Chemicals Codex, North Capitol Street, NW., suite 700, 3d Ed. (1981), p. 284, which is incor- 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) The ingredient is used as an anti- the following current good manufac- microbial agent as defined in turing practice conditions of use: § 170.3(o)(2) of this chapter; flavoring (1) The ingredient is used as a pH agent and adjuvant as defined in control agent as defined in § 170.3(o)(23) § 170.3(o)(12) of this chapter; and pH of this chapter and as a processing aid control agent as defined in § 170.3(o)(23) as defined in § 170.3(o)(24) of this chap- of this chapter. ter. (d) The ingredient is used in food at (2) The ingredient is used in foods at levels not to exceed current good man- levels not to exceed current good man- ufacturing practice in accordance with ufacturing practice.
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(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. This regula- tion does not authorize its use in in- [48 FR 52444, Nov. 18, 1983] fant foods and infant formulas. The af- § 184.1764 Sodium hypophosphite. firmation of this ingredient as gen- erally recognized as safe (GRAS) as a (a) Sodium hypophosphite (NaH2PO2, direct human food ingredient is based CAS Reg. No. 7681–53–0) is a white, upon the following current good manu- odorless, deliquescent granular powder facturing practice conditions of use: with a saline taste. It is also prepared (1) The ingredient is used as an emul- as colorless, pearly crystalline plates. sifier as defined in § 170.3(o)(8) of this It is soluble in water, alcohol, and chapter; a flavor enhancer as defined in glycerol. It is prepared by neutraliza- § 170.3(o)(11) of this chapter; a flavoring tion of hypophosphorous acid or by di- agent or adjuvant as defined in rect aqueous alkaline hydrolysis of § 170.3(o)(12) of this chapter; a humec- white phosphorus. tant as defined in § 170.3(o)(16) of this (b) FDA is developing food-grade chapter; and a pH control agent as de- specifications for sodium fined in § 170.3(o)(23) of this chapter. hypophosphite in cooperation with the (2) The ingredient is used in food at National Academy of Sciences. In the levels not to exceed current good man- interim, the ingredient must be of a ufacturing practice. suitable purity for its intended use. (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 limitations other than current good waived. manufacturing practice. The affirma- tion of this ingredient as generally rec- [52 FR 10886, Apr. 6, 1987] ognized as safe (GRAS) as a direct human food ingredient is based upon § 184.1769a Sodium metasilicate. the following current good manufac- (a) Sodium metasilicate (CAS Reg. turing practice conditions of use: No. 6834–92–0) is a strongly alkaline (1) The ingredient is used as an emul- white powder. It does not occur natu- sifier or stabilizer, as defined in rally but rather is synthesized by melt- §§ 170.3(o)(8) and 170.3(o)(28) of this ing sand with sodium carbonate at 1400 chapter. °C. The commercially available forms (2) The ingredient is used in cod-liver of sodium metasilicate are the anhy- oil emulsions at levels not to exceed drous form (Na2SiO3), the pentahydrate current good manufacturing practice. (Na2SiO3·5H2O), and the nonahydrate (d) Prior sanctions for this ingredient (Na2SiO3·9H2O). different from the use established in (b) FDA is developing food-grade this section do not exist or have been specifications for sodium metasilicate waived. in cooperation with the National Acad- emy of Sciences. In the interim, the in- [47 FR 38277, Aug. 31, 1982] gredient must be of a purity suitable for its intended use. § 184.1768 Sodium lactate. (c) In accordance with § 184.1(b)(1), (a) Sodium lactate (C3H5O3Na, CAS the ingredient is used in food with no Reg. No. 72–17–3) is the sodium salt of limitation other than current good lactic acid. It is prepared commercially manufacturing practice. The affirma- by the neutralization of lactic acid tion of this ingredient as generally rec- with sodium hydroxide. ognized as safe (GRAS) as a direct (b) FDA is developing food-grade human food ingredient is based upon specifications for sodium lactate in co- the following current good manufac- operation with the National Academy turing practice conditions of use: of Sciences. In the interim, this ingre- (1) The ingredient is used as a proc- dient must be of a purity suitable for essing aid as defined in § 170.3(o)(24) of its intended use. this chapter.
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(2) The ingredient is used to treat the cheeses as defined in § 170.3(n)(5) of this following foods at levels not to exceed chapter; confections and frostings as current good manufacturing practice: defined in § 170.3(n)(9) of this chapter; for use in washing and lye peeling of gelatins, puddings, and fillings as de- fruits, vegetables, and nuts when used fined in § 170.3(n)(22) of this chapter; in accordance with § 173.315 of this jams and jellies as defined in chapter; for use as a denuding agent in § 170.3(n)(28) of this chapter; meat prod- tripe; for use as a hog scald agent in re- ucts as defined in § 170.3(n)(29) of this moving hair; and for use as a corrosion chapter; and soft candy as defined in preventative in canned and bottled § 170.3(n)(38) of this chapter. water when used in accordance with § 103.35 of this chapter. (d) Prior sanctions for this ingredient (d) Prior sanctions for this ingredient different from the uses established in different from the uses established in this section do not exist or have been this section do not exist or have been waived. waived. [49 FR 13142, Apr. 3, 1984] [50 FR 38781, Sept. 25, 1985; 50 FR 42011, Oct. 17, 1985] § 184.1792 Sodium sesquicarbonate. (a) Sodium sesquicarbonate § 184.1784 Sodium propionate. (Na2CO3·NaHCO3·2H2O, CAS Reg. No. (a) Sodium propionate (C3H5NaO2, 533–96–0) is prepared by: (1) Partial CAS Reg. No. 137–40–6) is the sodium carbonation of soda ash solution fol- salt of propionic acid. It occurs as lowed by crystallization, centrifuga- colorless, transparent crystals or a tion, and drying; (2) double refining of granular crystalline powder. It is odor- trona ore, a naturally occurring im- less, or has a faint acetic-butyric acid odor, and is deliquescent. It is prepared pure sodium sesquicarbonate. by neutralizing propionic acid with so- (b) The ingredient meets the speci- dium hydroxide. fications of the Food Chemicals Codex, (b) The ingredients meets the speci- 3d Ed. (1981), p. 299, which is incor- fications of the Food Chemicals Codex, porated by reference. Copies are avail- 3d Ed. (1981), p. 296, which is incor- able from the National Academy Press, porated by reference. Copies are avail- 2101 Constitution Ave. NW., Wash- able from the the National Academy ington, DC 20418, or available for in- Press, 2101 Constitution Ave. NW., spection at the Office of the Federal Washington DC 20418, or available for Register, 800 North Capitol Street, inspection at the Office of the Federal NW., suite 700, Washington, DC 20408. Register, 800 North Capitol Street, (c) In accordance with § 184.1(b)(1), NW., suite 700, Washington, DC 20408. the ingredient is used in food with no (c) In accordance with § 184.1(b)(1), limitation other than current good the ingredient is used in food with no manufacturing practice. The affirma- limitation other than current good tion of this ingredient as generally rec- manufacturing practice. The affirma- ognized as safe (GRAS) as a direct tion of this ingredient as generally rec- human food ingredient is based upon ognized as safe (GRAS) as a direct the following current good manufac- human food ingredient is based upon turing practice conditions of use: the following current good manufac- (1) The ingredient is used as a pH turing practice conditions of use: control agent as defined in § 170.3(o)(23) (1) The ingredient is used as an anti- microbial agent as defined in of this chapter. § 170.3(o)(2) of this chapter and a fla- (2) The ingredient is used in cream at voring agent as defined in § 170.3(o)(12) levels not to exceed current good man- of this chapter. ufacturing practice. Current good man- (2) The ingredient is used in the fol- ufacturing practice utilizes a level of lowing foods at levels not to exceed the ingredient sufficient to control lac- current good manufacturing practice: tic acid prior to pasteurization and baked goods as defined in § 170.3(n)(1) of churning of cream into butter. this chapter; nonalcoholic beverages as (d) Prior sanctions for this ingredient defined in § 170.3(n)(3) of this chapter; different from the uses established in
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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. 296, which is incor- [48 FR 52443, Nov. 18, 1983] porated by reference. Copies are avail- § 184.1801 Sodium tartrate. able from the National Academy Press, 2101 Constitution Ave. NW., Wash- (a) Sodium tartrate (C H Na O ·2H O, 4 4 2 6 2 ington, DC 20418, or available for in- CAS Reg. No. 868–18–8) is the disodium spection at the Office of the Federal salt of L¥(+)¥tartaric acid. It occurs Register, 800 North Capitol Street, as transparent, colorless, and odorless NW., suite 700, Washington, DC 20408. crystals. It is obtained as a byproduct (c) In accordance with § 184.1(b)(1), of wine manufacture. the ingredient is used in food with no (b) The ingredient meets the speci- limitation other than current good fications of the Food Chemicals Codex, manufacturing practice. The affirma- 3d Ed. (1981), p. 303, which is incor- tion of this ingredient as generally rec- porated by reference. Copies are avail- ognized as safe (GRAS) as a direct able from the National Academy Press, human food ingredient is based upon 2101 Constitution Ave. NW., Wash- the following current good manufac- ington, DC 20418, or available for in- turing practice conditions of use: spection at the Office of the Federal Register, 800 North Capitol Street, (1) The ingredient is used as an emul- NW., suite 700, Washington, DC 20408. sifier as defined in § 170.3(o)(8) of this (c) In accordance with § 184.1(b)(1), chapter and as a pH control agent as the ingredient is used in food with no defined in § 170.3(o)(23) 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: ognized as safe (GRAS) as a direct cheeses as defined in § 170.3(n)(5) of this human food ingredient is based upon chapter and jams and jellies as defined the following current good manufac- in § 170.3(n)(28) of this chapter. turing practice conditions of use: (d) Prior sanctions for this ingredient (1) The ingredient is used as an emul- different from the uses established in sifier as defined in § 170.3(o)(8) of this this section do not exist or have been chapter and as a pH control agent as waived. defined in § 170.3(o)(23) of this chapter. [48 FR 52447, Nov. 18, 1983] (2) The ingredient is used in the fol- lowing foods at levels not to exceed § 184.1807 Sodium thiosulfate. current good manufacturing practice: (a) Sodium thiosulfate (Na2S2O3·5H2O, cheeses as defined in§ 170.3(n)(5) of this CAS Reg. No. 010102–0917–097) is also chapter; fats and oils as defined in known as sodium hyposulfite. It is pre- § 170.3(n)(12) of this chapter; and jams pared synthetically by the reaction of and jellies as defined in § 170.3(n)(28) of sulfides and sulfur dioxide (SO2), the this chapter. reaction of sulfur and sulfite, or the ox- (d) Prior sanctions for this ingredient idation of metal sulfides and different from the uses established in hydrosulfides. this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the ‘‘Food Chemicals [48 FR 52447, Nov. 18, 1983] Codex,’’ 3d Ed. (1981), p. 304, which is in- corporated by reference. Copies may be § 184.1804 Sodium potassium tartrate. obtained from the National Academy (a) Sodium potassium tartrate Press, 2101 Constitution Ave. NW., (C4H4KNaO6·4H2O, CAS Reg. No. 304–59– Washington, DC 20418, or may be exam- 6) is the sodium potassium salt of ined at the Office of the Federal Reg- L¥(+)¥tartaric acid and is also called ister, 800 North Capitol Street, NW., the Rochelle salt. It occurs as colorless suite 700, Washington, DC 20408. crystals or as a white, crystalline pow- (c) The ingredient is used as a formu- der and has a cooling saline taste. It is lation aid as defined in § 170.3(o)(14) of obtained as a byproduct of wine manu- this chapter and reducing agent as de- facture. fined in § 170.3(o)(22) of this chapter.
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(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. to exceed good manufacturing practice. (d) The ingredient is used in food at Current good manufacturing practice levels not to exceed good manufac- results in a maximum level, as served, turing practices. Current good manu- of 0.00005 percent for alcoholic bev- facturing practice in the use of sorbitol erages as defined in § 170.3(n)(2) of this results in a maximum level of 99 per- chapter and 0.1 percent for table salt as cent in hard candy and cough drops as defined in § 170.3(n)(26) of this chapter. defined in § 170.3(n)(25) of this chapter, (e) Prior sanctions for this ingredient 75 percent in chewing gum as defined in different from the uses established in § 170.3(n)(6) of this chapter, 98 percent this section do not exist or have been in soft candy as defined in § 170.3(n)(38) waived. of this chapter, 30 percent in non- standardized jams and jellies, commer- [43 FR 22938, May 30, 1978, as amended at 49 FR 5613, Feb. 4, 1984] cial, as defined in § 170.3(n)(28) of this chapter, 30 percent in baked goods and § 184.1835 Sorbitol. baking mixes as defined in § 170.3(n)(1) (a) Sorbitol is the chemical 1,2,3,4,5,6- of this chapter, 17 percent in frozen dairy desserts and mixes as defined in hexanehexol (C6H14O6), a hexahydric al- cohol, differing from mannitol prin- § 170.3(n)(20) of this chapter, and 12 per- cipally by having a different optical ro- cent in all other foods. tation. Sorbitol is produced by the (e) The label and labeling of food electrolytic reduction, or the transi- whose reasonably foreseeable consump- tion metal catalytic hydrogenation of tion may result in a daily ingestion of sugar solutions containing glucose or 50 grams of sorbitol shall bear the fructose. statement: ‘‘Excess consumption may (b) The ingredient meets the speci- have a laxative effect.’’ fications of the ‘‘Food Chemicals (f) Prior sanctions for this ingredient Codex,’’ 3d Ed. (1981), p. 308, which is in- different from the uses established in corporated by reference. Copies may be this regulation do not exist or have obtained from the National Academy been waived. Press, 2101 Constitution Ave. NW., [42 FR 14653, Mar. 15, 1977, as amended at 49 Washington, DC 20418, or may be exam- FR 5613, Feb. 14, 1984] ined at the Office of the Federal Reg- ister, 800 North Capitol Street, NW., § 184.1845 Stannous chloride (anhy- suite 700, Washington, DC 20408. drous and dihydrated). (c) The ingredient is used as an (a) Stannous chloride is anhydrous or anticaking agent and free-flow agent as contains two molecules of water of hy- defined in § 170.3(o)(1) of this chapter, dration. Anhydrous stannous chloride curing and pickling agent as defined in (SnCl2, CAS Reg. No. 7772–99–8) is the § 170.3(o)(5) of this chapter, drying chloride salt of metallic tin. It is pre- agent as defined in § 170.3(o)(7) of this pared by reacting molten tin with ei- chapter, emulsifier and emulsifier salt ther chlorine or gaseous tin tetra- as defined in § 170.3(o)(8) of this chap- chloride. Dihydrated stannous chloride ter, firming agent as defined in (SnCl2·2H2O, CAS Reg. No. 10025–0969– § 170.3(o)(10) of this chapter, flavoring 091) is the chloride salt of metallic tin agent and adjuvant as defined in that contains two molecules of water. § 170.3(o)(12) of this chapter, formula- It is prepared from granulated tin sus- tion aid as defined in § 170.3(o)(14) of pended in water and hydrochloric acid this chapter, humectant as defined in or chlorine. § 170.3(o)(16) of this chapter, lubricant (b) Both forms of the ingredient meet and release agent as defined in the specifications of the Food Chemi- § 170.3(o)(18) of this chapter, nutritive cals Codex, 3d Ed. (1981), p. 312, which is sweetener as defined in § 170.3(o)(21) of incorporated by reference. Copies are this chapter, sequestrant as defined in available from the National Academy § 170.3(o)(26) of this chapter, stabilizer Press, 2101 Constitution Ave. NW., and thickener as defined in § 170.3(o)(28) Washington, DC 20418, or available for of this chapter, surface-finishing agent inspection at the Office of the Federal
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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 an anti- ufacturing practice. oxidant as defined in § 170.3(o)(3) of this (d) Prior sanctions for this ingredient chapter. different from the uses established in (d) 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 in accordance with [48 FR 51907, Nov. 15, 1983] § 184.(b)(1). Current good manufacturing practice results in a maximum level, as § 184.1851 Stearyl citrate. served, of 0.0015 percent or less; cal- (a) Stearyl citrate is a mixture of the culated as tin, for all food categories. mono-, di-, and tristearyl esters of cit- (e) Prior sanctions for this ingredient ric acid. It is prepared by esterifying different from those uses established in citric acid with stearyl alcohol. this section do not exist or have been (b) The Food and Drug Administra- waived. tion, in cooperation with the National Academy of Sciences, is developing [47 FR 27816, June 25, 1982] food-grade specifications for stearyl citrate. In the interim, this ingredient § 184.1848 Starter distillate. must be of a purity suitable for its in- (a) Starter distillate (butter starter tended use. distillate) is a steam distillate of the (c) In accordance with § 184.1(b)(1), culture of any or all of the following the ingredient is used in food with no species of bacteria grown on a medium limitation other than current good consisting of skim milk usually for- manufacturing practice. The affirma- tified with about 0.1 percent citric acid: tion of this ingredient as generally rec- Streptococcus lactis, S. cremoris, S. lactis ognized as safe (GRAS) as a direct subsp. diacetylactis, Leuconostoc human food ingredient is based upon citrovorum, and L. dextranicum. The in- the following current good manufac- gredient contains more than 98 percent turing practice conditions of use: water, and the remainder is a mixture (1) The ingredient is used as an anti- of butterlike flavor compounds. Diace- oxidant as defined in § 170.3(o)(3) of this tyl is the major flavor component, con- chapter; an emulsifier and emulsifier stituting as much as 80 to 90 percent of salt as defined in § 170.3(o)(8) of this the mixture of organic flavor com- chapter; a sequestrant as defined in pounds. Besides diacetyl, starter dis- § 170.3(o)(26) of this chapter; and a sur- tillate contains minor amounts of acet- face-active agent as defined in aldehyde, ethyl formate, ethyl acetate, § 170.3(o)(29) of this chapter. acetone, ethyl alcohol, 2-butanone, (2) The ingredient is used in mar- acetic acid, and acetoin. garine in accordance with § 166.110 of (b) FDA is developing food-grade this chapter; in nonalcoholic beverages specifications for starter distillate in as defined in § 170.3(n)(3) of this chap- cooperation with the National Acad- ter; and in fats and oils as defined in emy of Sciences. In the interim, this § 170.3(n)(12) of this chapter at levels ingredient must be of a purity suitable not to exceed current good manufac- for its intended use. 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. The affirma- forth in part 181 of this chapter, do not tion of this ingredient as generally rec- exist or have been waived. ognized as safe (GRAS) as a direct [59 FR 63897, Dec. 12, 1994] human food ingredient is based upon the following current good manufac- § 184.1854 Sucrose.
turing practice conditions of use: (a) Sucrose (C12H22O11, CAS Reg. No. (1) The ingredient is used as a fla- 57–50–11–1) sugar, cane sugar, or beet voring agent and adjuvant as defined in sugar is the chemical β-D- § 170.3(o)(12) of this chapter. fructofuranosyl-α-D-glucopyranoside.
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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 diffusion, then clarified and evapo- weight of ash. The solution is colorless, rated. odorless, and flavorless, except for (b) FDA is developing food-grade sweetness. It is produced by the hydrol- specifications for sucrose in coopera- ysis or partial hydrolysis of sucrose tion with the National Academy of with safe and suitable acids or en- Sciences. In the interim, this ingre- zymes. dient must be of a purity suitable for its intended use. (b) FDA is developing food-grade (c) In accordance with § 184.1(b)(1), specifications for invert sugar in co- the ingredient is used in food with no operation with the National Academy limitation other than current good of Sciences. In the interim, this ingre- manufacturing practice. dient must be of a purity suitable for (d) Prior sanctions for this ingredient its intended use. 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 [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, manufacturing practice. 1989] (d) Prior sanctions for this ingredient different from the uses established in § 184.1857 Corn sugar. this section do not exist or have been
(a) Corn sugar (C6H12O6, CAS Reg. No. waived. 50–99–7), commonly called D-glucose or dextrose, is the chemical α-D- [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, 1989] glucopyranose. It occurs as the anhy- drous or the monohydrate form and is § 184.1865 Corn syrup. produced by the complete hydrolysis of corn starch with safe and suitable acids (a) Corn syrup, commonly called or enzymes, followed by refinement and ‘‘glucose sirup’’ or ‘‘glucose syrup,’’ is crystallization from the resulting hy- obtained by partial hydrolysis of corn drolysate. starch with safe and suitable acids or (b) The ingredient meets the speci- enzymes. It may also occur in the de- fications of the Food Chemicals Codex, hydrated form (dried glucose sirup). 3d Ed. (1981), pp. 97–98 under the head- Depending on the degree of hydrolysis, ing ‘‘Dextrose,’’ which is incorporated corn syrup may contain, in addition to by reference in accordance with 5 glucose, maltose and higher U.S.C. 552(a) and 1 CFR part 1. Copies saccharides. are available from the National Acad- (b) The ingredient meets the speci- emy Press, 2101 Constitution Ave., NW., fications as defined and determined in Washington, DC 20418, or available for § 168.120(b) or § 168.121(a) of this chapter, inspection at the Office of the Federal Register, 800 North Capitol Street, as appropriate. FDA, in cooperation NW., suite 700, Washington, DC 20408. with the National Academy of (c) In accordance with § 184.1(b)(1), Sciences, is undertaking a study to de- the ingredient is used in food with no termine if additional food-grade speci- limitation other than current good fications for corn syrup are necessary. manufacturing 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 do not exist or have been manufacturing practice. waived. (d) Prior sanctions for this ingredient [53 FR 44876, Nov. 7, 1988] different from the uses established in this section do not exist or have been § 184.1859 Invert sugar. waived. (a) Invert sugar (CAS Reg. No. 8013– [53 FR 44876, Nov. 7, 1988] 17–0) is an aqueous solution of inverted
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§ 184.1866 High fructose corn syrup. Register, 800 North Capitol Street, (a) High fructose corn syrup, a sweet, NW., suite 700, Washington, DC 20408. nutritive saccharide mixture con- (c) In accordance with § 184.1(b)(1), taining either approximately 42 or 55 the ingredient is used in food with no percent fructose, is prepared as a clear limitation other than current good aqueous solution from high dextrose- manufacturing practice. The affirma- equivalent corn starch hydrolysate by tion of this ingredient as generally rec- partial enzymatic conversion of glu- ognized as safe (GRAS) as a direct cose (dextrose) to fructose using an in- human food ingredient is based upon soluble glucose isomerase enzyme prep- the following current good manufac- aration described in § 184.1372. The turing practice conditions of use: product containing more than 50 per- (1) The ingredient is used as a fla- cent fructose (dry weight) is prepared voring agent and adjuvant as defined in through concentration of the fructose § 170.3(o)(12) of this chapter or as a nu- portion of the mixture containing less trient supplement as defined in than 50 percent fructose. § 170.3(o)(20) of this chapter. (b) The ingredient shall conform to (2) The ingredient is used in food at the identity and specifications listed in levels not to exceed current good man- the monograph entitled ‘‘High-Fruc- ufacturing practice. Thiamine hydro- tose Corn Syrup’’ in the Food Chemi- chloride may be used in infant formula cals Codex, 4th ed. (1996), pp. 191–192, in accordance with section 412(g) of the which is incorporated by reference in Federal Food, Drug, and Cosmetic Act accordance with 5 U.S.C. 552(a) and 1 (the Act) or with regulations promul- CFR part 51. Copies are available from gated under section 412(a)(2) of the Act. the Office of Premarket Approval, Cen- (d) Prior sanctions for this ingredient ter for Food Safety and Applied Nutri- different from the uses established in tion (HFS–200), Food and Drug Admin- this section do not exist or have been istration, 200 C St. SW., Washington, waived. DC 20204–0001, or may be examined at [48 FR 55124, Dec. 9, 1983] the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., rm. § 184.1878 Thiamine mononitrate. 3321, Washington, DC, or at the Office (a) Thiamine mononitrate of the Federal Register, 800 North Cap- (C H N O S, CAS Reg. No. 532–43–4) is itol St. NW., suite 700, Washington, DC. 12 17 5 4 the mononitrate salt of thiamine. It (c) In accordance with § 184.1(b)(1), occurs as white crystals or a white the ingredient is used in food with no crystalline powder and is prepared limitation other than current good from thiamine hydrochloride by dis- manufacturing practice. solving the hydrochloride salt in alka- [61 FR 43450, Aug.23, 1996] line solution followed by precipitation of the nitrate half-salt with a stoichio- § 184.1875 Thiamine hydrochloride. metric amount of nitric acid. (a) Thiamine hydrochloride (b) The ingredient meets the speci- (C12H17C1N4OS·HCl, CAS Reg. No. 67–03– fications of the Food Chemicals Codex, 8) is the chloride-hydrochloride salt of 3d Ed. (1981), p. 325, which is incor- thiamine. It occurs as hygroscopic porated by reference. Copies are avail- white crystals or a white crystalline able from the National Academy Press, powder. The usual method of preparing 2101 Constitution Ave. NW., Wash- this substance is by linking the ington, DC 20418, or available for in- preformed thiazole and pyrimidine ring spection at the Office of the Federal systems. Register, 800 North Capitol Street, (b) The ingredient meets the speci- NW., suite 700, Washington, DC 20408. fications of the Food Chemicals Codex, (c) In accordance with § 184.1(b)(1), 3d Ed. (1981), p. 324, which is incor- the ingredient is used in food with no porated by reference. Copies are avail- limitation other than current good able from the National Academy Press, manufacturing practice. The affirma- 2101 Constitution Ave. NW., Wash- tion of this ingredient as generally rec- ington, DC 20418, or available for in- ognized as safe (GRAS) as a direct spection at the Office of the Federal human food ingredient is based upon
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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 [49 FR 13348, Apr. 4, 1984] § 170.3(o)(20) of this chapter. (2) The ingredient is used in food at § 184.1901 Triacetin. levels not to exceed current good man- (a) Triacetin (C8 H14O6, CAS Reg. No. ufacturing practice. Thiamine mono- 102–76–1), also known as 1,2,3,- nitrate may be used in infant formula propanetriol triacetate or glyceryl in accordance with section 412(g) of the triacetate, is the triester of glycerin Federal Food, Drug, and Cosmetic Act and acetic acid. Triacetin can be pre- (the Act) or with regulations promul- pared by heating glycerin with acetic gated under section 412(a)(2) of the Act. anhydride alone or in the presence of (d) Prior sanctions for this ingredient finely divided potassium hydrogen sul- different from the uses established in fate. It can also be prepared by the re- this section do not exist or have been action of oxygen with a liquid-phase waived. mixture of allyl acetate and acetic acid [48 FR 55124, Dec. 9, 1983] using a bromide salt as a catalyst. (b) The ingredient meets the speci- § 184.1890 α-Tocopherols. fications of the Food Chemicals Codex, 3d Ed. (1981), pp. 337–338, as revised by (a) The α-tocopherols that are the the First Supplement to the 3d Ed., subject of this GRAS affirmation regu- which is incorporated by reference in lation are limited to the following: accordance with 5 U.S.C. 552(a). Copies α (1) d- -Tocopherol (CAS Reg. No. 59– are available from the National Acad- ′ 02–9) is the chemical [2R,4 R,8prime;R]- emy Press, 2102 Constitution Ave., NW., ′ ′ ′ 2,5,7,8-tetramethyl-2-(4 ,8 ,12 -trimethyl- Washington, DC 20418, or available for tridecyl)-6-chromanol. It occurs com- inspection at the Office of the Federal mercially as a concentrate and is a red, Register, 800 North Capitol Street, nearly odorless, viscous oil. It is ob- NW., suite 700, Washington, DC 20005. tained by vacuum steam distillation of (c) In accordance with § 184.1(b)(1), edible vegetable oil products. the ingredient is used in food with no (2) dl-α-Tocopherol (CAS Reg. No. limitation other than current good 10191–41–0) is a mixture of manufacturing practice. The affirma- stereoisomers of 2,5,7,8-tetramethyl-2- tion of this ingredient as generally rec- (4′,8′,12′-trimethyl-tridecyl)-6- ognized as safe (GRAS) as a direct chromanol. It is chemically syn- human food ingredient is based upon thesized by condensing racemic the following current good manufac- isophytol with trimethyl hydro- turing practice conditions of use: quinone. It is a pale yellow viscous oil (1) The ingredient is used in food as a at room temperature. flavoring agent and adjuvant as defined (b) The ingredients meet the speci- in § 170.3(o)(12) of this chapter; a formu- fications of the Food Chemicals Codex, lation aid as defined in § 170.3(o)(14) of 3d Ed. (1981), pp. 330–331, which is incor- this chapter; and humectant as defined porated by reference. Copies are avail- in § 170.3(o)(16) of this chapter; and a able from the National Academy Press, solvent and vehicle as defined in 2101 Constitution Ave. NW., Wash- § 170.3(o)(27) of this chapter. ington, DC 20418, or available for in- (2) The ingredient is used in the fol- spection at the Office of the Federal lowing foods at levels not to exceed Register, 800 North Capitol Street, current good manufacturing practice: NW., suite 700, Washington, DC 20408. baked goods and baking mixes as de- (c) In accordance with § 184.1(b)(3), fined in § 170.3(n)(1) of this chapter, al- the affirmation of the ingredients as coholic beverages as defined in generally recognized as safe is limited § 170.3(n)(2) of this chapter; non- to the following conditions of use while alcoholic beverages and beverage bases the agency concludes the general eval- as defined in § 170.3(n)(3) of this chap- uation of all food uses of tocopherols: ter; chewing gum as defined in (1) The ingredients are used as inhibi- § 170.3(n)(6) of this chapter; confections tors of nitrosamine formation. and frostings as defined in § 170.3(n)(9)
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of this chapter; frozen dairy dessert (d) Prior sanctions for this ingredient and mixes as defined in § 170.3(n)(20) of different from the uses established in this chapter; gelatins, puddings, and this section do not exist or have been fillngs as defined in § 170.3(n)(22) of this waived. chapter; hard candy as defined in [54 FR 7404, Feb. 21, 1989; 54 FR 10482, Mar. 13, § 170.3(n)(25) of this chapter; and soft 1989] candy as defined in § 170.3(n)(38) of this chapter. § 184.1911 Triethyl citrate. (d) Prior sanctions for this ingredient different from the uses established in (a) Triethyl citrate (C12H20O7, CAS this section do not exist or have been Reg. No. 77–93–0) is the triethyl ester of waived. citric acid. It is prepared by esterifying citric acid with ethyl alcohol and oc- [54 FR 7404, Feb. 21, 1989] curs as an odorless, practically color- less, oily liquid. § 184.1903 Tributyrin. (b) The ingredient meets the speci- (a) Tributyrin (C15H26O6, CAS Reg. fications of the Food Chemicals Codex, No. 60–01–5), also known as butyrin or 3d ed. (1981), p. 339, which is incor- glyceryl tributyrate, is the triester of porated by reference in accordance glycerin and butyric acid. It is pre- with 5 U.S.C. 552(a) and 1 CFR part 51. pared by esterification of glycerin with Copies are available from the National excess butyric acid. Academy Press, 2101 Constitution Ave. (b) The ingredient meets the speci- NW., Washington, DC 20418, and the fication of the Food Chemicals Codex, Center for Food Safety and Applied Nu- 3d Ed. (1981), p. 416, which is incor- trition (HFS–200), 200 C St. SW., Wash- porated by reference in accordance ington, DC 20204, or may be examined with 5 U.S.C. 552(a). Copies are avail- at the Office of the Federal Register, able from the National Academy Press, 800 North Capitol St. NW., suite 700, 2101 Constitution Ave. NW., Wash- Washington, DC. 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 20005. 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 generaly rec- turing practice conditions of use: ognized as safe (GRAS) as a direct (1) The ingredient is used as a fla- human food ingredient is based upon voring agent as defined in § 170.3(o)(12) the following current good manufac- of this chapter; a solvent and vehicle as turing practice conditions of use: defined in § 170.3(o)(27) of this chapter; (1) The ingredient is used in food as a and a surface-active agent as defined in flavoring agent and adjuvant as defined § 170.3(o)(29) of this chapter. in § 170.3(o)(12) of this chapter. (2) The ingredient is used in foods at (2) The ingredient is used in the fol- levels not to exceed current good man- lowing foods at levels not to exceed ufacturing practice. current good manufacturing practice; (d) Prior sanctions for this ingredient baked goods as defined in § 170.3(n)(1) of different from the uses established in this chapter; alcoholic beverages as de- this section, or different from those set fined in § 170.3(n)(2) of this chapter; forth in part 181 of this chapter, do not nonalcoholic beverages as defined in exist or have been waived. § 170.3(n)(3) of this chapter; fats and oils as defined in § 170.3(n)(12) of this chap- [59 FR 63897, Dec. 12, 1994] ter; frozen dairy desserts and mixes as defined in § 170.3(n)(20) of this chapter; § 184.1914 Trypsin. gelatins, puddings and fillngs as de- (a) Trypsin (CAS Reg. No. 9002–07–7) fined in § 170.3(n)(22) of this chapter; is an enzyme preparation obtained and soft candy as defined in from purified extracts of porcine or bo- § 170.3(n)(38) of this chapter. vine pancreas. It is a white to tan
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amorphous powder. Its characterizing (1) The ingredient is used as a formu- enzyme activity is that of a peptide hy- lation aid as defined in § 170.3(o)(14) of drolase (EC 3.4.21.4). this chapter and as a fermentation aid. (b) The ingredient meets the general (2) The ingredient is used in yeast- requirements and additional require- raised bakery products; in alcoholic ments for enzyme preparations in the beverages as defined in § 170.3(n)(2) of Food Chemicals Codex, 3d ed. (1981), p. this chapter; and in gelatin products. 110, which is incorporated by reference (d) Prior sanctions for this ingredient in 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 National Academy Press, 2101 Con- waived. stitution Ave. NW., Washington, DC [48 FR 51616, Nov. 10, 1983, as amended at 49 20418, or may be examined at the Office FR 19816, May 10, 1984] of Premarket Approval (HFS–200), Food and Drug Administration, 200 C St. § 184.1924 Urease enzyme preparation from Lactobacillus fermentum. SW., Washington, DC, and the Office of the Federal Register, 800 North Capitol (a) This enzyme preparation is de- St. NW., suite 700, Washington, DC. rived from the nonpathogenic, (c) In accordance with § 184.1(b)(1), nontoxicogenic bacterium Lactobacillus the ingredient is used in food with no fermentum. It contains the enzyme limitation other than current good urease (CAS Reg. No. 9002–13–5), which manufacturing practice. The affirma- facilitates the hydrolysis of urea to ammonia and carbon dioxide. It is pro- tion of this ingredient as GRAS as a di- duced by a pure culture fermentation rect food ingredient is based upon the process and by using materials that are following current good manufacturing generally recognized as safe (GRAS) or practice conditions of use: are food additives that have been ap- (1) The ingredient is used as an en- proved for this use by the Food and zyme as defined in § 170.3(o)(9) of this Drug Administration (FDA). chapter to hydrolyze proteins or (b) The ingredient meets the general polypeptides. and additional requirements for en- (2) The ingredient is used in food at zyme preparations in the ‘‘Food Chemi- levels not to exceed current good man- cals Codex,’’ 3d ed. (1981), pp. 107–110, ufacturing practice. which is incorporated by reference in [60 FR 32911, June 26, 1995] accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from § 184.1923 Urea. the National Academy Press, 2101 Con- stitution Ave. NW., Washington, DC (a) Urea (CO(NH ) CAS Reg. No. 57– 2 2, 20418, or available for inspection at the 13–6) is the diamide of carbonic acid Office of the Federal Register, 800 and is also known as carbamide. It is a North Capitol St. NW., suite 700, Wash- white, odorless solid and is commonly ington, DC. produced from CO2 by ammonolysis or (c) In accordance with § 184.1(b)(1), from cyanamide by hydrolysis. the ingredient is used in food with no (b) FDA is developing food-grade limitation other than current good specifications for urea in cooperation manufacturing practice. The affirma- with the National Academy of tion of this ingredient as GRAS as a di- Sciences. In the interim, this ingre- rect human food ingredient is based dient must be of a purity suitable for upon the following current good manu- its intended use. facturing practice conditions of use: (c) In accordance with § 184.1(b)(1), (1) The ingredient is used in wine, as the ingredient is used in food with no defined in 27 CFR 2.5 and 4.10, as an en- limitation other than current good zyme as defined in § 170.3(o)(9) of this manufacturing practice. The affirma- chapter to convert urea to ammonia tion of this ingredient as generally rec- and carbon dioxide. ognized as safe as a direct human food (2) The ingredient is used in food at ingredient is based upon the following levels not to exceed current good man- current good manufacturing practice ufacturing practice. Current good man- conditions of use: ufacturing practice is limited to use of
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this ingredient in wine to inhibit for- this section do not exist or have been mation of ethyl carbamate. waived. [57 FR 60473, Dec. 21, 1992] [48 FR 51610, Nov. 10, 1983]
§ 184.1930 Vitamin A. § 184.1945 Vitamin B12. (a)(1) Vitamin A (retinol; CAS Reg. (a) Vitamin B12, also known as cyano- No. 68–26–8) is the alcohol 9,13-di- cobalamin (C63H88CoN14O14P, CAS Reg. methyl-7-(1,1,5-trimethyl-6-cyclohexen- No. 68–0919–099), is produced commer- cially from cultures of Streptomyces 5-yl)-7,9,11,13-nonatetraen-15-ol. It may griseus. be nearly odorless or have a mild fishy (b) The ingredient meets the speci- odor. Vitamin A is extracted from fish fications of the Food Chemicals Codex, liver oils or produced by total syn- 3d Ed. (1981), p. 343, which is incor- β thesis from -ionone and a propargyl porated by reference. Copies are avail- halide. able from the National Academy Press, (2) Vitamin A acetate (retinyl ace- 2101 Constitution Ave. NW., Wash- tate; CAS Reg. No. 127–47–9) is the ace- ington, DC 20418, or available for in- tate ester of retinol. It is prepared by spection at the Office of the Federal esterifying retinol with acetic acid. Register, 800 North Capitol Street, (3) Vitamin A palmitate (retinyl NW., suite 700, Washington, DC 20408. palmitate; CAS Reg. No. 79–81–2) is the (c) In accordance with § 184.1(b)(1), palmitate ester of retinol. It is pre- the ingredient is used in food with no pared by esterifying retinol with pal- limitation other than current good mitic acid. manufacturing practice. The affirma- (b) The ingredient meets the speci- tion of this ingredient as generally rec- fications for vitamin A in the Food ognized as safe (GRAS) as a direct Chemicals Codex, 3d Ed. (1981), p. 342, human food ingredient is based upon which is incorporated by reference. the following current good manufac- Copies are available from the National turing practice conditions of use: Academy Press, 2101 Constitution Ave. (1) The ingredient is used as a nutri- NW., Washington, DC 20418, or avail- ent supplement as defined in § 170.3(o)(20) of this chapter. able for inspection at the Office of the (2) The ingredient is used in food at Federal Register, 800 North Capitol levels not to exceed current good man- Street, NW., suite 700, Washington, DC ufacturing practice. Vitamin B12 also 20408. 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 (GRAS) as a direct different from the uses established in human food ingredient is based upon this section do not exist or have been the following current good manufac- waived. turing practice conditions of use: [50 FR 6341, Feb. 15, 1985] (1) The ingredient is used in food as a nutrient supplement as defined in § 184.1950 Vitamin D. § 170.3(o)(20) of this chapter. (a) Vitamin D is added to food as the (2) The ingredient is used in foods at following food ingredients: levels not to exceed current good man- (1) Crystalline vitamin D2 (C28H44O, ufacturing practice. Vitamin A may be CAS Reg. No. 50–14–6), also known as used in infant formula in accordance ergocalciferol, is the chemical 9,10- with section 412(g) of the Federal Food, seco(5Z,7E,22E)-5,7,10(19),22- Drug, and Cosmetic Act (the act) or ergostatetraen-3-ol. The ingredient is with regulations promulgated under produced by ultraviolet irradiation of section 412(a)(2) of the Act. ergosterol isolated from yeast and re- (d) Prior sanctions for this ingredient lated fungi and is purified by crys- different from the uses established in tallization.
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(2) Crystalline vitamin D3 (C27H44O, (2) Vitamin D may be used in infant CAS Reg. No. 67–97–0), also known as formula in accordance with section cholecalciferol, is the chemical 9,10- 412(g) of the Federal Food, Drug, and seco(5Z,7E,)-5,7,10(19)-cholestatrien-3- Cosmetic Act (the act) or with regula- ol. Vitamin D3 occurs in, and is iso- tions promulgated under section lated from, fish liver oils. It is also 412(a)(2) of the act. manufactured by ultraviolet irradia- (3) Vitamin D may be used in mar- tion of 7-dehydrocholesterol produced garine in accordance with § 166.110 of from cholesterol. It is purified by crys- this chapter. (d) Prior sanctions for these ingredi- tallization. Vitamin D3 is the vitamin D form that is produced endogenously ents different from the uses established in humans through sunlight activation in this section do not exist or have of 7-dehydrocholesterol in the skin. been waived.
(3) Vitamin D2 resin and vitamin D3 [50 FR 30152, July 24, 1985] resin are the concentrated forms of ir- § 184.1973 Beeswax (yellow and white). radiated ergosterol (D2) and irradiated 7-dehydrocholesterol (D3) that are sepa- (a) Beeswax (CAS Reg. No. 8012–89–3) rated from the reacting materials in is a secretory product of honey bees paragraphs (a) (1) and (2) of this sec- used as a structural material in honey- tion. The resulting products are sold as combs. Beeswax is prepared from hon- food sources of vitamin D without fur- eycombs after removal of the honey by ther purification. draining or centrifuging. The combs are melted in hot water or steam or (b) Vitamin D2 and vitamin D3 as crystals meet the specifications of the with solar heat, and strained. The wax Food Chemicals Codex, 3d Ed. (1981), is refined by melting in hot water to which sulfuric acid or alkali may be pp. 344 and 345, which is incorporated added to extract impurities. The re- by reference. Copies are available from sulting wax is referred to as yellow the National Academy Press, 2101 Con- beeswax. White beeswax is produced by stitution Ave. NW., Washington, DC bleaching the constituent pigments of 20418, or available for inspection at the yellow beeswax with peroxides, or pref- Office of the Federal Register, 800 erably it is bleached by sun light. North Capitol Street, NW., suite 700, (b) The ingredient meets the speci- Washington, DC 20408. FDA is devel- fications of the ‘‘Food Chemicals oping food-grade specifications for vi- Codex,’’ 3d Ed. (1981), pp. 34–35, which is tamin D2 resin and vitamin D3 resin in incorporated by reference. Copies may cooperation with the National Acad- be obtained from the National Acad- emy of Sciences. In the interim, these emy Press, 2101 Constitution Ave. NW., resins must be of a purity suitable for Washington, DC 20418, or may be exam- their intended use. ined at the Office of the Federal Reg- (c)(1) In accordance with § 184.1(b)(2), ister, 800 North Capitol Street, NW., the ingredients are used in food as the suite 700, Washington, DC 20408. sole source of added vitamin D only (c) The ingredient is used as a fla- within the following specific limita- voring agent and adjuvant as defined in tions: § 170.3(o)(12) of this chapter, as a lubri- cant as defined in § 170.3(o)(18) of this Maximum levels in Category of food food (as served) Functional use chapter, and as a surface-finishing agent as defined in § 170.3(o)(30) of this Breakfast cereals, 350 (IU/100 Nutrient supple- chapter. ¤ 170.3(n)(4) of grams). ment, (d) The ingredient is used in food, in this chapter. ¤ 170.3(o)(20) of this chapter. accordance with § 184.1(b)(1) of this Grain products and 90(IU/100 grams) Do. chapter, at levels not to exceed good pastas, manufacturing practice. Current good ¤ 170.3(n)(23) of manufacturing practice results in a this chapter. Milk, ¤ 170.3(n)(30) 42 (IU/100 grams) Do. maximum level, as served, of: 0.065 per- of this chapter. cent for chewing gum as defined in Milk products, 89 (IU/100 grams) Do. § 170.3(n)(6) of this chapter; 0.005 per- ¤ 170.3(n)(31) of cent for confections and frostings as this chapter. defined in § 170.3(n)(9) of this chapter;
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0.04 percent for hard candy as defined § 184.1978 Carnauba wax. in § 170.3(n)(25) of this chapter; 0.1 per- (a) Carnauba wax (CAS Reg. No. 008– cent for soft candy as defined in 015–869) is obtained from the leaves and § 170.3(n)(38) of this chapter; and 0.002 buds of the Brazilian wax palm percent or less for all other food cat- Copernicia cerifera Martius. The wax is egories. hard, brittle, sparingly soluble in cold [43 FR 14644, Apr. 7, 1978, as amended at 49 organic solvents and insoluble in FR 5613, Feb. 14, 1984; 50 FR 49536, Dec. 3, water. It is marketed in five grades 1985] designated No. 1 through No. 5. Grades No. 4 and No. 5 represent the bulk of § 184.1976 Candelilla wax. the commercial trade volume. These (a) Candelilla wax (CAS Reg. No. commercial grades consist chiefly of 8006–44–8) is obtained from the can- C24 to C32 normal saturated delilla plant. It is a hard, yellowish- monofunctional fatty acids and normal brown, opaque-to-translucent wax. saturated monofunctional primary al- Candelilla wax is prepared by immers- cohols. ing the plants in boiling water con- (b) The ingredient meets the speci- taining sulfuric acid and skimming off fications of the Food Chemicals Codex, the wax that rises to the surface. It is 3d Ed. (1981), p. 73, which is incor- composed of about 50 percent hydro- porated by reference. Copies are avail- carbons with smaller amounts of esters able from the National Academy Press, and free acids. 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), p. 67, 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: (1) The ingredient is used as an manufacturing practice. The affirma- anticaking agent as defined § 170.3(o)(1) tion of this ingredient as generally rec- of this chapter; as a formulation aid as ognized as safe (GRAS) as a direct defined in § 170.3(o)(14) of this chapter; human food ingredient is based upon as a lubricant and release agent as de- the following current good manufac- fined in § 170.3(o)(18) of this chapter; turing practice conditions of use: and as a surface-finishing agent as de- (1) The ingredient is used as a lubri- fined in § 170.3(o)(30) of this chapter. cant as defined in § 170.3(o)(18) of this (2) The ingredient is used in the fol- chapter and as a surface-finishing lowing foods at levels not to exceed agent as defined in § 170.3(o)(30) of this current good manufacturing practice: chapter. baked goods and baking mixes as de- (2) The ingredient is used in the fol- fined in § 170.3(n)(1) of this chapter; lowing foods at levels not to exceed chewing gun as defined in § 170.3(n)(6) of current good manufacturing practice: this chapter; confections and frostings in chewing gum as defined in as defined in § 170.3(n)(9) of this chap- § 170.3(n)(6) of this chapter and in hard ter; fresh fruits and fruit juices as de- candy as defined in § 170.3(n)(25) of this fined in § 170.3(n)(16) of this chapter; chapter. gravies and sauces as defined in (d) Prior sanctions for this ingredient § 170.3(n)(24) of this chapter; processed different from the uses established in fruits and fruit juices as defined in this section do not exist or have been § 170.3(n)(35) of this chapter; and soft waived. candy as defined in § 170.3(n)(38) of this [48 FR 51617, Nov. 10, 1983] chapter.
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(d) Prior sanctions for this ingredient istration, 200 C St. SW., rm. 3321, Wash- different from the uses established in ington, DC, or at the Office of the Fed- this section do not exist or have been eral Register, 800 North Capitol St. waived. NW., suite 700, Washington, DC. [48 FR 51147, Nov. 7, 1983] (i) Protein content, 10 to 15 percent— as determined by the methods pre- § 184.1979 Whey. scribed in section 16.036 (liquid sample), entitled ‘‘Total Nitrogen—Official (a)(1) Whey. Whey is the liquid sub- Final Action’’ under the heading stance obtained by separating the co- agulum from milk, cream, or skim ‘‘Total Solids,’’ or in section 16.193 (dry milk in cheesemaking. Whey obtained sample), entitled ‘‘Kjeldahl Method’’ from a procedure, in which a signifi- under the heading ‘‘Protein—Official cant amount of lactose is converted to Final Action.’’ lactic acid, or from the curd formation (ii) Fat content, 0.2 to 2.0 percent—as by direct acidification of milk, is determined by the methods prescribed known as acid whey. Whey obtained in section 16.059 (liquid sample), from a procedure in which there is in- ‘‘Reese-Gottlieb Method [Reference significant conversion of lactose to lac- Method] (11)—Official Final Action’’ tic acid is known as sweet whey. Sweet under the heading ‘‘Fat,’’ or in section whey has a maximum titratable acid- 16.199 (dry sample), entitled ‘‘Fat in ity of not more than 0.16 percent, cal- Dried Milk (45)—Official Final Action.’’ culated as lactic acid, and an alka- (iii) Ash content, 7 to 14 percent—as linity of ash of not more than 225 milli- determined by the methods prescribed liters of 0.1N hydrochloric acid per 100 in section 16.035 (liquid sample), enti- grams. The acidity of whey, sweet or tled ‘‘Ash (5)—Official Final Action’’ acid, may be adjusted by the addition under the heading ‘‘Total Solids,’’ or in of safe and suitable pH-adjusting ingre- section 16.196 (dry sample), entitled dients. ‘‘Ash—Official Final Action’’ under the (2) Concentrated whey. Concentrated heading ‘‘Dried Milk, Nonfat Dry Milk, whey is the liquid substance obtained and Malted Milk.’’ by the partial removal of water from (iv) Lactose content, 61 to 75 per- whey, while leaving all other constitu- cent—as determined by the methods ents in the same relative proportions prescribed in section 16.057 (liquid sam- as in whey. ple), entitled ‘‘Gravimetric Method— (3) Dry or dried whey. Dry or dried Official Final Action’’ under the head- whey is the dry substance obtained by ing ‘‘Lactose,’’ or in section 31.061 (dry the removal of water from whey, while sample), entitled ‘‘Lane-Eynon General leaving all other constituents in the Volumetric Method’’ under the heading same relative proportions as in whey. ‘‘Lactose—Chemical Methods—Official (b) The ingredients meet the fol- Final Action.’’ lowing specifications: (v) Moisture content, 1 to 8 percent— (1) The analysis of whey, con- as determined by the methods pre- centrated whey, and dry (dried) whey, scribed in section 16.192, entitled on a dry product basis, based on ana- ‘‘Moisture (41)—Official Final Action’’ lytical methods in the referenced sec- under the heading ‘‘Dried Milk, Nonfat tions of ‘‘Official Methods of Analysis Dry Milk, and Malted Milk.’’ of the Association of Official Analyt- (vi) Solids content, variable—as de- ical Chemists,’’ 13th ed. (1980), which is termined by the methods prescribed in 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
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parts per million (0.001 percent) as de- may be adjusted by the addition of safe termined by the method described in and suitable pH-adjusting ingredients. the ‘‘Food Chemicals Codex,’’ 4th ed. (b) The reduced lactose whey meets (1996), pp. 760–761, which is incorporated the following specifications: by reference in accordance with 5 (1) The analysis of reduced lactose U.S.C. 552(a) and 1 CFR part 51. Copies whey, on a dry product basis, based on are available from the National Acad- analytical methods in the referenced emy Press, Box 285, 2101 Constitution sections of ‘‘Official Methods of Anal- Ave. NW., Washington, DC 20055 (Inter- ysis of the Association of Official Ana- net address ‘‘http://www.nap.edu’’), or lytical Chemists,’’ 13th ed. (1980), which may be examined at the Center for is incorporated by reference in accord- Food Safety and Applied Nutrition’s ance with 5 U.S.C. 552(a) and 1 CFR Library, Food and Drug Administra- part 51, is given in paragraphs (b)(1)(i) tion, 200 C St. SW., rm. 3321, Wash- through (b)(1)(vii) of this section. Cop- ington, DC, or at the Office of the Fed- ies may be obtained from the Associa- eral Register, 800 North Capitol St. tion of Official Analytical Chemists NW., suite 700, Washington, DC. International, 481 North Frederick (3) The whey must be derived from Ave., suite 500, Gaithersburg, MD 20877– milk that has been pasteurized, or the 2504, or may be examined at the Center whey and modified whey product must for Food Safety and Applied Nutri- be subjected to pasteurization tech- tion’s Library, Food and Drug Admin- niques or its equivalent before use in istration, 200 C St. SW., rm. 3321, Wash- food. ington, DC, or at the Office of the Fed- (c) Whey, concentrated whey, and dry eral Register, 800 North Capitol St. (dried) whey may be used in food in ac- NW., suite 700, Washington, DC. cordance with good manufacturing (i) Protein content, 16 to 24 percent— practice as indicated in § 184.1(b)(1). as determined by the methods pre- (d) The label on the whey form sold scribed in section 16.036 (liquid sample), to food manufacturers shall read as fol- entitled ‘‘Total Nitrogen—Official lows: Final Action’’ under the heading (1) For whey: ‘‘(Sweet or acid) whey’’ ‘‘Total Solids,’’ or in section 16.193 (dry or ‘‘whey (ll% titratable acidity). sample), entitled ‘‘Kjeldahl Method’’ (2) For concentrated whey: ‘‘Con- under the heading ‘‘Protein—Official centrated (sweet or acid) whey, ll% Final Action.’’ solids’’ or ‘‘Concentrated whey (ll% (ii) Fat content, 1 to 4 percent—as de- titratable acidity), ll% solids’’. termined by the methods prescribed in (3) For dry (dried) whey: ‘‘Dry (dried) section 16.059 (liquid sample), ‘‘Reese- (sweet or acid) whey’’ or ‘‘dry (dried) Gottlieb Method [Reference Method] whey, (ll% titratable acidity)’’. (11)—Official Final Action’’ under the heading ‘‘Fat,’’ or in section 16.199 (dry (e) Whey, concentrated whey, or dry sample), entitled ‘‘Fat in Dried Milk (dried) whey in a finished food product (45)—Official Final Action.’’ shall be listed as ‘‘whey.’’ (iii) Ash content, 11 to 27 percent—as [46 FR 44439, Sept. 4, 1981; 47 FR 7410, Feb. 19, determined by the methods prescribed 1982, as amended at 54 FR 24899, June 12, 1989; in section 16.035 (liquid sample), enti- 64 FR 1760, Jan. 12, 1999] tled ‘‘Ash (5)—Official Final Action’’ under the heading ‘‘Total Solids,’’ or in § 184.1979a Reduced lactose whey. section 16.196 (dry sample), entitled (a) Reduced lactose whey is the sub- ‘‘Ash—Official Final Action’’ under the stance obtained by the removal of lac- heading ‘‘Dried Milk, Nonfat Dry Milk, tose from whey. The lactose content of and Malted Milk.’’ the finished dry product shall not ex- (iv) Lactose content, not more than ceed 60 percent. Removal of the lactose 60 percent—as determined by the meth- is accomplished by physical separation ods prescribed in section 16.057 (liquid techniques such as precipitation, filtra- sample), entitled ‘‘Gravimetric Meth- tion, or dialysis. As with whey, reduced od—Official Final Action’’ under the lactose whey can be used as a fluid, heading ‘‘Lactose,’’ or in section 31.061 concentrate, or a dry product form. (dry sample), entitled ‘‘Lane–Eynon The acidity of reduced lactose whey General Volumetric Method’’ under the
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heading ‘‘Lactose—Chemical Meth- actual percentage is based is supplied ods—Official Final Action.’’ to the food manufacturer. (v) Moisture content, 1 to 6 percent— (e) The presence of reduced lactose as determined by the method pre- whey in a finished food product shall be scribed in section 16.192, entitled listed as ‘‘reduced lactose whey.’’ ‘‘Moisture (41)—Official Final Action’’ [46 FR 44440, Sept. 4, 1981, as amended at 54 under the heading ‘‘Dried Milk, Nonfat FR 24899, June 12, 1989; 64 FR 1760, Jan. 12, Dry Milk, and Malted Milk.’’ 1999] (vi) Solids content, variable—as de- termined by the methods prescribed in § 184.1979b Reduced minerals whey. section 16.032, entitled ‘‘Method I—Offi- (a) Reduced minerals whey is the sub- cial Final Action’’ under the heading stance obtained by the removal of a ‘‘Total Solids.’’ portion of the minerals from whey. The (vii) Titratable Acidity, variable—as dry product shall not contain more determined by the methods prescribed than 7 percent ash. Reduced minerals in section 16.023, entitled ‘‘Acidity (2)— whey is produced by physical separa- Official Final Action’’ under the head- tion techniques such as precipitation, ing ‘‘Milk,’’ or by an equivalent poten- filtration, or dialysis. As with whey, tiometric method. reduced minerals whey can be used as a (2) Limits of impurities are: Heavy fluid, concentrate, or a dry product metals (as lead). Not more than 10 form. The acidity of reduced minerals parts per million (0.001 percent), as de- whey may be adjusted by the addi- termined by the method described in tional of safe and suitable pH-adjusting the ‘‘Food Chemicals Codex,’’ 4th ed. ingredients. (1996), pp. 760–761, which is incorporated (b) The reduced minerals whey meets by reference in accordance with 5 the following specifications: U.S.C. 552(a) and 1 CFR part 51. Copies (1) The analysis of reduced minerals are available from the National Acad- whey, on a dry product basis, based on emy Press, Box 285, 2101 Constitution analytical methods in the referenced Ave. NW., Washington, DC 20055 (Inter- sections of ‘‘Official Methods of Anal- net address ‘‘http://www.nap.edu’’), or ysis of the Association of Official Ana- may be examined at the Center for lytical Chemists,’’ 13th ed. (1980), which Food Safety and Applied Nutrition’s is incorporated by reference in accord- Library, Food and Drug Administra- ance with 5 U.S.C. 552(a) and 1 CFR tion, 200 C St. SW., rm. 3321, Wash- part 51, is given in paragraphs (b)(1)(i) ington, DC, or at the Office of the Fed- through (b)(1)(vii) of this section. Cop- eral Register, 800 North Capitol St. ies may be obtained from the Associa- NW., suite 700, Washington, DC. tion of Official Analytical Chemists (3) The reduced lactose whey shall be International, 481 North Frederick derived from milk that has been pas- Ave., suite 500, Gaithersburg, MD 20877– teurized, or the reduced lactose whey 2504, or may be examined at the Center shall be subjected to pasteurization for Food Safety and Applied Nutri- techniques or its equivalent before use tion’s Library, Food and Drug Admin- in food. istration, 200 C St. SW., rm. 3321, Wash- (c) Reduced lactose whey may be ington, DC, or at the Office of the Fed- used in food in accordance with good eral Register, 800 North Capitol St. manufacturing practice as indicated in NW., suite 700, Washington, DC. § 184.1(b)(1). (i) Protein content, 10 to 24 percent— (d) The percent of lactose present on as determined by the methods pre- a dry product basis, i.e., ‘‘reduced lac- scribed in section 16.036 (liquid sample), tose whey (ll% lactose),’’ shall be de- entitled ‘‘Total Nitrogen—Official clared on the label of the package sold Final Action’’ under the heading to food manufacturers. The percent of ‘‘Total Solids,’’ or in section 16.193 (dry lactose may be declared in 5-percent sample), entitled ‘‘Kjeldahl Method’’ increments, expressed as a multiple of under the heading ‘‘Protein—Official 5, not greater than the actual percent- Final Action.’’ age of lactose in the product, or as a (ii) Fat content, 1 to 4 percent—as de- actual percentage provided that an termined by the methods prescribed in analysis of the product on which the section 16.059 (liquid sample), ‘‘Reese-
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Gottlieb Method [Reference Method] eral Register, 800 North Capitol St. (11)—Official Final Action’’ under the NW., suite 700, Washington, DC. heading ‘‘Fat,’’ or in section 16.199 (dry (3) The reduced minerals whey shall sample), entitled ‘‘Fat in Dried Milk be derived from milk that has been pas- (45)—Official Final Action.’’ teurized, or the reduced minerals whey (iii) Ash content, maximum 7 per- shall be subjected to pasteurization cent—as determined by the methods techniques or its equivalent before use prescribed in section 16.035 (liquid sam- in food. ple), entitled ‘‘Ash (5)—Official Final (c) The reduced minerals whey may Action’’ under the heading ‘‘Total Sol- be used in food in accordance with good ids,’’ or in section 16.196 (dry sample), manufacturing practice as indicated in entitled ‘‘Ash—Official Final Action’’ § 184.1(b)(1). under the heading ‘‘Dried Milk, Nonfat (d) The percent of minerals present Dry Milk, and Malted Milk.’’ on a dry product basis, i.e., ‘‘reduced minerals whey (ll% minerals),’’ shall (iv) Lactose content, maximum 85 be declared on the label of the package percent—as determined by the methods sold to food manufacturers. The per- prescribed in section 16.057 (liquid sam- cent of minerals may be declared in 2- ple), entitled ‘‘Gravimetric Method— percent increments expressed as a mul- Official Final Action’’ under the head- tiple of 2, not greater than the actual ing ‘‘Lactose,’’ or in section 31.061 (dry percentage of minerals in the product, sample), entitled ‘‘Lane-Eynon General or as an actual percentage provided Volumetric Method’’ under the heading that an analysis of the product on ‘‘Lactose—Chemical Methods—Official which the actual percentage is based is Final Action.’’ supplied to the food manufacturer. (v) Moisture content, 1 to 6 percent— (e) The presence of reduced minerals as determined by the methods pre- whey in a finished food product shall be scribed in section 16.192, entitled listed as ‘‘reduced minerals whey’’. ‘‘Moisture (41)—Official Final Action’’ under the heading ‘‘Dried Milk, Nonfat [46 FR 44441, Sept. 4, 1981, as amended at 54 Dry Milk, and Malted Milk.’’ FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, 1999] (vi) Solids content, variable—as de- termined by the methods prescribed in § 184.1979c Whey protein concentrate. section 16.032, entitled ‘‘Method I—Offi- (a) Whey protein concentrate is the cial Final Action’’ under the heading substance obtained by the removal of ‘‘Total Solid.’’ sufficient nonprotein constituents from (vii) Titratable Acidity, variable—as whey so that the finished dry product determined by the methods prescribed contains not less than 25 percent pro- in section 16.023, entitled ‘‘Acidity (2)— tein. Whey protein concentrate is pro- Official Final Action’’ under the head- duced by physical separation tech- ing ‘‘Milk,’’ or by an equivalent poten- niques such as precipitation, filtration, tiometric method. or dialysis. As with whey, whey protein (2) Limits of impurities are: Heavy concentrate can be used as a fluid, con- metals (as lead). Not more than 10 centrate, or dry product form. The parts per million (0.001 percent), as de- acidity of whey protein concentrate termined by the method described in may be adjusted by the addition of safe the ‘‘Food Chemicals Codex,’’ 4th ed. and suitable pH-adjusting ingredients. (1996), pp. 760–761, which is incorporated (b) The whey protein concentrate by reference in accordance with 5 meets the following specifications: U.S.C. 552(a) and 1 CFR part 51. Copies (1) The analysis of whey protein con- are available from the National Acad- centrate, on a dry product basis, based emy Press, Box 285, 2101 Constitution on analytical methods in the ref- Ave. NW., Washington, DC 20055 (Inter- erenced sections of ‘‘Official Methods net address ‘‘http://www.nap.edu’’), or of Analysis of the Association of Offi- may be examined at the Center for cial Analytical Chemists,’’ 13th ed. Food Safety and Applied Nutrition’s (1980), which is incorporated by ref- Library, Food and Drug Administra- erence in accordance with 5 U.S.C. tion, 200 C St. SW., rm. 3321, Wash- 552(a) and 1 CFR part 51, is given in ington, DC, or at the Office of the Fed- paragraphs (b)(1)(i) through (b)(1)(vii)
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of this section. Copies may be obtained (vii) Titratable Acidity, variable—as from the Association of Official Ana- determined by the methods prescribed lytical Chemists International, 481 in section 16.023, entitled ‘‘Acidity (2)— North Frederick Ave., suite 500, Gai- Official Final Action’’ under the head- thersburg, MD 20877–2504, or may be ex- ing ‘‘Milk,’’ or by an equivalent poten- amined at the Center for Food Safety tiometric method. and Applied Nutrition’s Library, Food (2) Limits of impurities are: Heavy and Drug Administration, 200 C St. metals (as lead). Not more than 10 SW., rm. 3321, Washington, DC, or at parts per million (0.001 percent), as de- the Office of the Federal Register, 800 termined by the method described in North Capitol St. NW., suite 700, Wash- the ‘‘Food Chemicals Codex,’’ 4th ed. ington, DC. (1996), pp. 760–761, which is incorporated (i) Protein content, minimum 25 per- cent—as determined by the methods by reference in accordance with 5 prescribed in section 16.036 (liquid sam- U.S.C. 552(a) and 1 CFR part 51. Copies ple), entitled ‘‘Total Nitrogen—Offi- are available from the National Acad- cials Final Action’’ under the heading emy Press, Box 285, 2101 Constitution ‘‘Total Solids,’’ or in section 16.193 (dry Ave. NW., Washington, DC 20055 (Inter- sample), entitled ‘‘Kjeldahl Method’’ net address ‘‘http://www.nap.edu’’), or under the heading ‘‘Protein—Official may be examined at the Center for Final Action.’’ Food Safety and Applied Nutrition’s (ii) Fat content, 1 to 10 percent—as Library, Food and Drug Administra- determined by the methods prescribed tion, 200 C St. SW., rm. 3321, Wash- in section 16.059 (liquid sample), ington, DC, or at the Office of the Fed- ‘‘Reese-Gottlieb Method [Reference eral Register, 800 North Capitol St. Method] (11)—Official Final Action’’ NW., suite 700, Washington, DC. under the heading ‘‘Fat,’’ or in section (3) The whey protein concentrate 16.199 (dry sample), entitled ‘‘Fat in shall be derived from milk that has Dried Milk (45)—Official Final Action.’’ been pasteurized, or the whey protein (iii) Ash content, 2 to 15 percent—as concentrate shall be subjected to pas- determined by the methods prescribed teurization techniques or its equiva- in section 16.035 (liquid sample), enti- lent before use in food. tled ‘‘Ash (5)—Official Final Action’’ (c) The whey protein concentrate under the heading ‘‘Total Solids,’’ or in may be used in food in accordance with section 16.196 (dry sample), entitled ‘‘Ash—Official Final Action’’ under the good manufacturing practice as indi- heading ‘‘Dried Milk, Nonfat Dry Milk, cated in § 184.1(b)(1). and Malted Milk.’’ (d) The percent of protein present on (iv) Lactose content, maximum 60 a dry product basis, i.e., ‘‘whey protein percent—as determined by the methods concentrate (ll% protein),’’ shall be prescribed in section 16.057 (liquid sam- declared on the label of the package ple), entitled ‘‘Gravimetric Method— sold to food manufacturers. The per- Official Final Action’’ under the head- cent of protein may be declared in 5- ing ‘‘Lactose,’’ or in section 31.061 (dry percent increments, expressed as a sample), entitled ‘‘Lane-Eynon General multiple of 5, not greater than the ac- Volumetric Method’’ under the heading tual percentage of protein in the prod- ‘‘Lactose—Chemical Methods—Official uct, or as an actual percentage pro- Final Action.’’ vided that an analysis of the product (v) Moisture content, 1 to 6 percent— on which the actual percentage is as determined by the methods pre- based is supplied to the food manufac- scribed in section 16.192, entitled turer. ‘‘Moisture (41)—Official Final Action’’ (e) The presence of whey protein con- under the heading ‘‘Dried Milk, Nonfat centrate in a finished food product Dry Milk, and Malted Milk.’’ shall be listed as ‘‘whey protein con- (vi) Solids content, variable—as de- centrate’’. termined by the methods prescribed in section 16.032, entitled ‘‘Method I—Offi- [46 FR 44441, Sept. 4, 1981, as amended at 54 cial Final Action’’ under the heading FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, ‘‘Total Solids.’’ 1999]
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§ 184.1983 Bakers yeast extract. (1) The ingredient is used as a sur- (a) Bakers yeast extract is the food face-finishing agent as defined in ingredient resulting from concentra- § 170.3(o)(30) of this chapter. tion of the solubles of mechanically (2) The ingredient is used in food at ruptured cells of a selected strain of levels not to exceed current good man- yeast, Saccharomyces cerevisiae. It may ufacturing practice. be concentrated or dried. (d) Prior sanctions for this ingredient (b) The ingredient meets the fol- different from the uses established in lowing specifications on a dry weight this section do not exist or have been basis: Less than 0.4 part per million waived. (ppm) arsenic, 0.13 ppm cadmium, 0.2 [50 FR 8999, Mar. 6, 1985] ppm lead, 0.05 ppm mercury, 0.09 ppm selenium, and 10 ppm zinc. § 184.1985 Aminopeptidase enzyme (c) The viable microbial content of preparation derived from the finished ingredient as a con- lactococcus lactis. centrate or dry material is: (a) Aminopeptidase enzyme prepara- (1) Less than 10,000 organisms/gram by aerobic plate count. tion is derived from the nonpathogenic (2) Less than 10 yeasts and molds/ and nontoxicogenic bacterium gram. Lactococcus lactis (previously named (3) Negative for Salmonella, E. coli, Streptococcus lactis). The preparation coagulase positive Staphylococci, Clos- contains the enzyme aminopeptidase tridium perfringens, Clostridium botu- (CAS Reg. No. 9031–94–1; EC 3.4.11.1) and linum, or any other recognized micro- other peptidases that hydrolyze milk bial pathogen or any harmful microbial proteins. The preparation is produced toxin. by pure culture fermentation. (d) The ingredient is used as a fla- (b) The ingredient meets the speci- voring agent and adjuvant as defined in fications for enzyme preparations in § 170.3(o)(12) of this chapter at a level the Food Chemicals Codex, 3d ed. (1981), not to exceed 5 percent in food. pp. 107–110, which are incorporated by (e) This regulation is issued prior to reference in accordance with 5 U.S.C. general evaluation of use of this ingre- 552(a) and 1 CFR part 51. Copies are dient in order to affirm as GRAS the available from the National Academy specific use named. Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be exam- § 184.1984 Zein. ined at the Division of Petition Control (a) Zein (CAS Reg. No. 9010–66–6) is (HFS–215), Center for Food Safety and one of the components of corn gluten. Applied Nutrition, Food and Drug Ad- It is produced commercially by extrac- ministration, 1110 Vermont Ave. NW., tion from corn gluten with alkaline suite 1200, Washington, DC, or at the aqueous isopropyl alcohol containing Office of the Federal Register, 800 sodium hydroxide. The extract is then North Capitol St. NW., suite 700, Wash- cooled, which causes the zein to pre- ington, DC. cipitate. (c) In accordance with § 184.1(b)(1), (b) FDA is developing food-grade the ingredient is used in food with no specifications for zein in cooperation limitations other than current good with the National Academy of manufacturing practice. The affirma- Sciences. In the interim, the igredient tion of this ingredient as generally rec- must be of a purity suitable for its in- ognized as safe as a direct human food tended use. ingredient is based upon the following (c) In accordance with § 184.1(b)(1), current good manufacturing practice the ingredient is used in food with no conditions of use: limitation other than current good (1) The ingredient is used as an en- manufacturing practice. The affirma- zyme, as defined in § 170.3(o)(9) of this tion of this ingredient as generally rec- chapter, as an optional ingredient for ognized as safe (GRAS) as a direct flavor development in the manufacture human food ingredient is based upon of cheddar cheese, in accordance with the following current good manufac- § 133.113 of this chapter, and in the turing practice conditions of use: preparation of protein hydrolysates.
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(2) The ingredient is used at levels 184 of this chapter are also GRAS as in- not to exceed current good manufac- direct human food ingredients in ac- turing practice. cordance with § 184.1(a) of this chapter. [60 FR 54193, Oct. 20, 1995] (b) The regulations in this part do not authorize direct addition of any PART 186—INDIRECT FOOD SUB- food ingredient to a food. They author- ize only the use of these ingredients as STANCES AFFIRMED AS GEN- indirect ingredients of food, through ERALLY RECOGNIZED AS SAFE migration from their immediate wrap- per, container, or other food-contact Subpart A—General Provisions surface. Any ingredient affirmed as Sec. GRAS in this part shall be used in ac- 186.1 Substances added indirectly to human cordance with current good manufac- food affirmed as generally recognized as turing practice. For the purpose of this safe (GRAS). part, current good manufacturing prac- Subpart B—Listing of Specific Substances tice includes the requirements that an Affirmed as GRAS indirect human food ingredient be of a purity suitable for its intended use, 186.1093 Sulfamic acid. and that it be used at a level no higher 186.1256 Clay (kaolin). than reasonably required to achieve its 186.1275 Dextrans. 186.1300 Ferric oxide. intended technical effect in the food- 186.1316 Formic acid. contact article. 186.1374 Iron oxides. (1) If the ingredient is affirmed as 186.1551 Hydrogenated fish oil. GRAS with no limitations on its condi- 186.1555 Japan wax. tions of use other than current good 186.1557 Tall oil. manufacturing practice, it shall be re- 186.1673 Pulp. 186.1750 Sodium chlorite. garded as GRAS if its conditions of use 186.1756 Sodium formate. are consistent with the requirements of 186.1770 Sodium oleate. paragraphs (b), (c), and (d) of this sec- 186.1771 Sodium palmitate. tion. When the Food and Drug Admin- 186.1797 Sodium sulfate. istration (FDA) determines that it is 186.1839 Sorbose. appropriate, the agency will describe AUTHORITY: 21 U.S.C. 321, 342, 348, 371. one or more current good manufac- SOURCE: 42 FR 14658, Mar. 15, 1977, unless turing practice conditions of use in the otherwise noted. regulation that affirms the GRAS sta- tus of the indirect ingredient. For ex- Subpart A—General Provisions ample, when the safety of an ingredient has been evaluated on the basis of lim- § 186.1 Substances added indirectly to ited conditions of use, the agency will human food affirmed as generally describe in the regulation that affirms recognized as safe (GRAS). the GRAS status of the indirect ingre- (a) The indirect human food ingredi- dient, one or more of these limited con- ents listed in this part have been re- ditions of use, which may include the viewed by the Food and Drug Adminis- category of food-contact surface(s), tration and determined to be generally technical effect(s) or functional use(s) recognized as safe (GRAS) for the pur- of the indirect ingredient, and the poses and under the conditions pre- level(s) of use. If the ingredient is used scribed, providing they comply with under conditions that are significantly the purity specifications listed in this different from those described in the part or, in the absence of purity speci- regulation, such use of a substance fications, are of a purity suitable for may not be GRAS. In such a case, a their intended use in accordance with manufacturer may not rely on the reg- § 170.30(h)(1) of this chapter. Certain in- ulation as authorizing that use but gredients in this part may also be used shall independently establish that the in food-contact surfaces in accordance use is GRAS or shall use the ingredient with parts 174, 175, 176, 177, 178 or in accordance with a food additive reg- § 179.45 of this chapter. Ingredients af- ulation. Persons seeking FDA approval firmed as GRAS for direct use in part of an independent determination that a
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use of an ingredient is GRAS may sub- regulation is determined to be appro- mit a GRAS petition in accordance priate as a result of submission of proof with § 170.35 of this chapter. of such an applicable prior sanction in (2) If the ingredient is affirmed as response to the proposal. GRAS with specific limitation(s), it [42 FR 14658, Mar. 15, 1977, as amended at 48 shall be used in food-contact surfaces FR 48457, 48459, Oct. 19, 1983] only within such limitation(s), includ- ing the category of food-contact sur- face(s), the functional use(s) of the in- Subpart B—Listing of Specific gredient, and the level(s) of use. Any Substances Affirmed as GRAS use of such an ingredient not in full compliance with each such established § 186.1093 Sulfamic acid. limitation shall require a food additive (a) Sulfamic acid (H3NO3S, CAS Reg. regulation. No. 5329–14–6) is a white crystalline (3) If the ingredient is affirmed as solid manufactured from urea, sulfur GRAS for a specific use, prior to gen- trioxide, and sulfuric acid. It is soluble eral evaluation of use of the ingredient, and highly ionized in water. other uses may also be GRAS. (b) In accordance with § 186.1(b)(1), (c) The listing of a food ingredient in the ingredient is used as an indirect this part does not authorize the use of food ingredient with no limitations such substance for the purpose of add- other than current good manufacturing ing the ingredient to the food through practice. The affirmation of this ingre- extraction from the food-contact sur- dient as generally recognized as safe face. (GRAS) as an indirect human food in- (d) The listing of a food ingredient in gredient is based upon the current good this part does not authorize the use of manufacturing practice of using this such substance in a manner that may ingredient in the manufacture of paper lead to deception to the consumer or to and paperboard that contact food. any other violation of the Federal (c) Prior sanctions for this ingredient Food, Drug, and Cosmetic Act (the different from the uses established in Act). this section do not exist or have been (e) If the Commissioner of Food and waived. Drugs is aware of any prior sanction for use of an ingredient under condi- [47 FR 29954, July 9, 1982] tions different from those proposed to be affirmed as GRAS, he will concur- § 186.1256 Clay (kaolin). rently propose a separate regulation (a) Clay (kaolin) Al2O3.2SiO2.nH2O, Cas covering such use of the ingredient Reg. No. 1332–58–7) consists of hydrated under part 181 of this chapter. If the aluminum silicate. The commercial Commissioner is unaware of any such products of clay (kaolin) contain vary- applicable prior sanction, the proposed ing quantities of alkalies and alkaline regulation will so state and will re- earths. Clay (kaolin) is a white to yel- quire any person who intends to assert lowish or grayish fine powder. There or rely on such sanction to submit are at least three different minerals, proof of its existence. Any regulation kaolinite, dickite, and nacrite, classi- promulgated pursuant to this section fied as kaolin. Kaolinite or china clay constitutes a determination that ex- is whiter, less contaminated with ex- cluded uses would result in adultera- traneous minerals, and less plastic in tion of the food in violation of section water. 402 of the Act, and the failure of any (b) In accordance with § 186.1(b)(1), person to come forward with proof of the ingredient is used as an indirect such an applicable prior sanction in re- human food ingredient with no limita- sponse to the proposal will constitute a tion other than current good manufac- waiver of the right to assert or rely on turing practice. The affirmation of this such sanction at any later time. The ingredient as generally recognized as notice will also constitute a proposal safe (GRAS) as an indirect human food to establish a regulation under part 181 ingredient is based upon the following of this chapter, incorporating the same current good manufacturing practice provisions, in the event that such a conditions of use:
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(1) The ingredient is used in the man- (2) The ingredient is used at levels ufacture of paper and paperboard that not to exceed current good manufac- contact food. turing practice. (2) The ingredient is used at levels (c) Prior sanctions for this ingredient not to exceed current good manufac- different from the uses established in turing practice. this section do not exist or have been (c) Prior sanctions for this ingredient waived. different from the uses established in this regulation do not exist or have [53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988] been waived. [47 FR 43367, Oct. 1, 1982] § 186.1316 Formic acid. (a) Formic acid (CH O CAS Reg. No. § 186.1275 Dextrans. 2 2, 64–18–6) is also referred to as methanoic (a) Dextrans (CAS Reg. No. 9004–54–0) acid or hydrogen carboxylic acid. It oc- are high molecular weight curs naturally in some insects and is polysaccharides produced by bacterial contained in the free acid state in a fermentation of sucrose. Commercially number of plants. Formic acid is pre- available dextrans are synthesized pared by the reaction of sodium for- from sucrose by Leuconostoc mate with sulfuric acid and is isolated mesenteroides strain NRRL B–512(F). by distillation. Partial depolymerization and purifi- (b) Formic acid is used as a con- cation of the fermented mixture shall stituent of paper and paperboard used produce a product that is free of viable for food packaging. microorganisms. (c) The ingredient is used at levels (b) The ingredient is used or intended not to exceed good manufacturing for use as a constituent of food-contact practice in accordance with § 186.1(b)(1). surfaces. (d) Prior sanctions for formic acid (c) The ingredient is used at levels different from the uses established in not to exceed good manufacturing this section do not exist or have been practice. waived. (d) Prior sanctions for this ingredient different from the uses established in [45 FR 22915, Apr. 4, 1980] this section do not exist or have been waived. § 186.1374 Iron oxides. [43 FR 29288, July 7, 1978, as amended at 48 (a) Iron oxides (oxides of iron, CAS FR 48457, Oct. 19, 1983] Reg. No. 97705–33–85) are undefined mix- tures of iron (II) oxide (CAS Reg. No. § 186.1300 Ferric oxide. 1345–25–1, black cubic crystals) and iron (a) Ferric oxide (iron (III) oxide, (III) oxide (CAS Reg. No. 1309–37–1, red- brown to black trigonal crystals). Fe2O3, CAS Reg. No. 1309–37–1) occurs naturally as the mineral hematite. It (b) In accordance with § 186.1(b)(1), may be prepared synthetically by heat- the ingredient is used as an indirect ing brown iron hydroxide oxide. The human food ingredient with no limita- product is red-brown to black trigonal tion other than current good manufac- crystals. turing practice. The affirmation of this (b) In accordance with § 186.1(b)(1), ingredient as generally recognized as the ingredient is used as an indirect safe (GRAS) as an indirect human food human food ingredient with no limita- ingredient is based upon the following tion other than current good manufac- current good manufacturing practice turing practice. The affirmation of this conditions of use: ingredient as generally recognized as (1) The ingredient is used as a con- safe (GRAS) as an indirect human food stituent of paper and paperboard used ingredient is based upon the following for food packaging. current good manufacturing practice (2) The ingredient is used at levels conditions of use: not to exceed current good manufac- (1) The ingredient is used as a con- turing practice. stituent of paper and paperboard used (c) Prior sanctions for this ingredient for food packaging. different from the uses established in
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this section do not exist or have been of tripalmitin. It is prepared from the waived. mesocarp by hot pressing of immature fruits of the oriental sumac, Rhus [53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988] succedanea (Japan, Taiwan, and Indo- China), R. vernicifera (Japan), and R. § 186.1551 Hydrogenated fish oil. trichocarpa (China, Indo-China, India, and Japan). Japan wax is soluble in hot (a) Hydrogenated fish oil (CAS Reg. alcohol, benzene, and naphtha, and in- No. 91078–95–4) is a class of oils pro- soluble in water and in cold alcohol. duced by partial hydrogenation of oils (b) In accordance with paragraph expressed from fish, primarily menha- (b)(1) of this section, the ingredient is den, and secondarily herring or tuna. used as an indirect human food ingre- Hydrogenation of fish oils uses cata- dient with no limitation other than lysts composed of either elemental current good manufacturing practice. nickel, elemental copper, or a mixture The affirmation of this ingredient as of these elements. The crude hydro- generally recognized as safe (GRAS) as genated fish oil is further processed by an indirect human food ingredient is alkali refining, bleaching, and deodori- based on the following current good zation by steam stripping. manufacturing practice conditions of (b) Hydrogenation of fish oils results use: in a final product with a melting point greater than 32 °C as determined by (1) The ingredient is used as a con- Section Cc 1–25, Official and Tentative stituent of cotton and cotton fabrics Methods of the American Oil Chemists’ used for dry food packaging. Society method (reapproved 1973) or (2) The ingredient is used at levels equivalent. The product has an approx- not to exceed current good manufac- imate fatty acid composition of 30 to 45 turing practice. percent saturated fatty acids, 40 to 55 (c) Prior sanctions for this ingredient 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 [60 FR 62208, Dec. 5, 1995] polyenoic fatty acids. The approximate percentages of total fatty acids by car- § 186.1557 Tall oil. bon chain length are 15 to 30 percent (a) Tall oil (CAS Reg. No. 8002–26–4) is each of C16, C18, C20, C22, less than 10 per- essentially the sap of the pine tree. It cent C14 or lower carbon chain length, is obtained commercially from the and less than 1 percent C24 or higher waste liquors of pinewood pulp mills carbon chain length fatty acids. and consists mainly of tall oil resin (c) The ingredient is used as a con- acids and tall oil fatty acids. 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 on 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 cotton and cotton fabrics used for dry 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 this section, or from those listed in
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part 181 of this chapter, do not exist or mercially, sodium oleate is made by have been waived. mixing and heating flaked sodium hy- droxide and oleic acid. [51 FR 16830, May 7, 1986] (b) In accordance with § 186.1(b)(1), § 186.1673 Pulp. the ingredient is used as a constituent of paper and paperboard for food pack- (a) Pulp is the soft, spongy pith in- side the stem of a plant such as wood, aging and as a component of lubricants straw, sugarcane, or other natural with incidental food contact in accord- plant sources. ance with § 178.3570 of this chapter, (b) The ingredient is used or intended with no limitation other than current for use as a constituent of food pack- good manufacturing practice. aging containers. (c) Prior sanctions for this ingredient (c) The ingredient is used in paper different from the uses established in and paperboard made by conventional this section do not exist or have been paper-making processes at levels not to waived. exceed good manufacturing practice. [51 FR 39372, Oct. 28, 1986] (d) Prior sanctions for this ingredient different from the uses established in § 186.1771 Sodium palmitate. this section do not exist or have been (a) Sodium palmitate (C16H31O2Na, waived. CAS Reg. No. 408–35–5) is the sodium § 186.1750 Sodium chlorite. salt of palmitic acid (hexadecanoic acid). It exists as a white to yellow (a) Sodium chlorite (NaCLO2, CAS powder. Commercially, sodium Reg. No. 7758–19–2) exists as slightly palmitate is made by mixing and heat- hygroscopic white crystals or flakes. It ing flaked sodium hydroxide and pal- is manufactured by passing chlorine di- mitic acid. oxide into a solution of sodium hydrox- (b) In accordance with § 186.1(b)(1), ide and hydrogen peroxide. the ingredient is used as a constituent (b) the ingredient is used at levels of paper and paperboard for food pack- from 125 to 250 parts per million as a aging with no limitation other than slimicide in the manufacture of paper current good manufacturing practice. and paperboard that contact food. (c) Prior sanctions for this ingredient [45 FR 16470, Mar. 14, 1980] different from the uses established in this section do not exist or have been § 186.1756 Sodium formate. waived. (a) Sodium formate (CHNaO2, CAS Reg. No. 141–53–7) is the sodium salt of [51 FR 39372, Oct. 28, 1986] formic acid. It is produced by the reac- § 186.1797 Sodium sulfate. tion of carbon monoxide with sodium hydroxide. (a) Sodium sulfate (Na2SO4, CAS Reg. (b) The ingredient is used as a con- No. 7757–82–6), also known as Glauber’s stituent of paper and paperboard used salt, occurs naturally and exists as for food packaging. colorless crystals or as a fine, white (c) The ingredient is used at levels crystalline powder. It is prepared by not to exceed good manufacturing the neutralization of sulfuric acid with practice in accordance with § 186.1(b)(1). sodium hydroxide. (d) Prior sanctions for sodium for- (b) The ingredient is used as a con- mate different from the uses estab- stituent of paper and paperboard used lished in this section do not exist or for food packaging, and cotton and cot- have been waived. ton fabric used for dry food packaging. (c) The ingredient is used at levels [45 FR 22915, Apr. 4, 1980] not to exceed good manufacturing § 186.1770 Sodium oleate. practice in accordance with § 186.1(b)(1). (d) Prior sanctions for this ingredient (a) Sodium oleate (C H O Na, CAS 18 33 2 different from the uses established in Reg. No. 143–19–1) is the sodium salt of this section do not exist or have been oleic acid (cis-9-octadecenoic acid). It waived. exists as a white to yellowish powder with a slight tallow-like odor. Com- [45 FR 6086, Jan. 25, 1980]
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§ 186.1839 Sorbose. Subpart C—Substances Prohibited From In- direct Addition to Human Food (a) Sorbose (L-sorbose, sorbinose) Through Food-Contact Surfaces (C6H12O6, CAS Reg. No. 87–79–6) is an orthorhombic, bisphenoidal crystalline 189.220 Flectol H. ketohexose. It was originally identifed 189.240 Lead solders. in the juice of mature berries from the 189.250 Mercaptoimidazoline and 2- mercaptoimidazoline. mountain ash (Sorbus aucuparia) where 189.280 4,4′-Methylenebis (2-chloroanaline). it occurs as the result of microbial oxi- 189.300 Hydrogenated 4,4′-isopropylidene- dation of sorbitol. It also occurs natu- diphenolphosphite ester resins. rally in other plants. Sorbose can be 189.301 Tin–coated lead foil capsules for synthesized by the catalytic hydro- wine bottles. genation of glucose to D-sorbitol. The AUTHORITY: 21 U.S.C. 321, 342, 348, 371. resulting sorbitol can be oxidized by SOURCE: 42 FR 14659, Mar. 15, 1977, unless Acetobacter xylinum or by Acetobacter otherwise noted. suboxydans. EDITORIAL NOTE: Nomenclature changes to (b) The ingredient is used or intended part 189 appear at 61 FR 14482, Apr. 2, 1996. for indirect food use as a constituent of cotton, cotton fabrics, paper, and pa- Subpart A—General Provisions perboard in contact with dry food. (c) The ingredient migrates to food at § 189.1 Substances prohibited from use levels not to exceed good manufac- in human food. turing practice. (a) The food ingredients listed in this (d) Prior sanctions for this ingredient section have been prohibited from use different from the uses established in in human food by the Food and Drug this section do not exist or have been Administration because of a deter- waived. mination that they present a potential risk to the public health or have not [43 FR 11698, Mar. 21, 1978, as amended at 48 been shown by adequate scientific data FR 48457, Oct. 19, 1983] to be safe for use in human food. Use of any of these substances in violation of PART 189—SUBSTANCES PROHIB- this section causes the food involved to ITED FROM USE IN HUMAN FOOD be adulterated in violation of the act. (b) This section includes only a par- tial list of substances prohibited from Subpart A—General Provisions use in human food, for easy reference Sec. purposes, and is not a complete list of 189.1 Substances prohibited from use in substances that may not lawfully be human food. used in human food. No substance may be used in human food unless it meets Subpart B—Substances Generally Prohib- all applicable requirements of the act. ited From Direct Addition or Use as (c) The Commissioner of Food and Human Food Drugs, either on his own initiative or on behalf of any interested person who 189.110 Calamus and its derivatives. has submitted a petition, may publish 189.113 Cinnamyl anthranilate. a proposal to establish, amend, or re- 189.120 Cobaltous salts and its derivatives. peal a regulation under this section on 189.130 Coumarin. the basis of new scientific evaluation 189.135 Cyclamate and its derivatives. or information. Any such petition shall 189.140 Diethylpyrocarbonate (DEPC). 189.145 Dulcin. include an adequate scientific basis to 189.155 Monochloroacetic acid. support the petition, pursuant to part 189.165 Nordihydroguaiaretic acid (NDGA). 10 of this chapter, and will be published 189.175 P–4000. for comment if it contains reasonable 189.180 Safrole. grounds. 189.190 Thiourea. [42 FR 14659, Mar. 15, 1977, as amended at 54 189.191 Chlorofluorocarbon propellants. FR 24899, June 12, 1989]
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Subpart B—Substances Generally § 189.120 Cobaltous salts and its de- Prohibited From Direct Addi- rivatives. tion or Use as Human Food (a) Cobaltous salts are the chemicals, CoC4H6O4, CoCl2, and CoSO4.They have § 189.110 Calamus and its derivatives. been used in fermented malt beverages as a foam stabilizer and to prevent (a) Calamus is the dried rhizome of ‘‘gushing.’’ Acorus calamus L. It has been used as a (b) Food containing any added cobal- flavoring compound, especially as the tous salts is deemed to be adulterated oil or extract. in violation of the act based upon an (b) Food containing any added order published in the FEDERAL REG- calamus, oil of calamus, or extract of ISTER of August 12, 1966 (31 FR 8788). calamus is deemed to be adulterated in violation of the act based upon an § 189.130 Coumarin. order published in the FEDERAL REG- (a) Coumarin is the chemical 1,2- ISTER of May 9, 1968 (33 FR 6967). benzopyrone, C9H6O2. It is found in (c) The analytical method used for tonka beans and extract of tonka detecting oil of calamus (β-asarone) is beans, among other natural sources, in the ‘‘Journal of the Association of and is also synthesized. It has been Official Analytical Chemists,’’ Volume used as a flavoring compound. 56, (Number 5), pages 1281 to 1283, Sep- (b) Food containing any added cou- tember 1973, which is incorporated by marin as such or as a constituent of reference. Copies are available from tonka beans or tonka extract is deemed the Association of Official Analytical to be adulterated under the act, based Chemists International, 481 North upon an order published in the FED- Frederick Ave., suite 500, Gaithersburg, ERAL REGISTER of March 5, 1954 (19 FR MD 20877–2504, also from the Division of 1239). Food and Color Additives, Center for (c) The analytical methods used for Food Safety and Applied Nutrition detecting coumarin in food are in sec- (HFS–200), Food and Drug Administra- tions 19.016–19.024 of the ‘‘Official Meth- tion, 200 C St. SW., Washington, DC ods of Analysis of the Association of 20204, or available for inspection at the Official Analytical Chemists,’’ 13th Ed. Office of the Federal Register, 800 (1980), which is incorporated by ref- North Capitol Street, NW., suite 700, erence. Copies may be obtained from the Association of Official Analytical Washington, DC 20408. Chemists International, 481 North [42 FR 14659, Mar. 15, 1977, as amended at 47 Frederick Ave., suite 500, Gaithersburg, FR 11855, Mar. 19, 1982; 54 FR 24899, June 12, MD 20877–2504, or may be examined at 1989] the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, § 189.113 Cinnamyl anthranilate. Washington, DC 20408. (a) The food additive cinnamyl an- [42 FR 14659, Mar. 15, 1977, as amended at 49 thranilate (C16H15NO2, CAS Reg. No. 87– FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 29–6) is the ester of cinnamyl alcohol 1989] and anthranilic acid. Cinnamyl an- thranilate is a synthetic chemical that § 189.135 Cyclamate and its deriva- has not been identified in natural prod- tives. ucts at levels detectable by available (a) Calcium, sodium, magnesium and methodology. It has been used as a fla- potassium salts of cyclohexane sul- voring agent in food. famic acid, (C6H12NO3S)2Ca, (b) Food containing any added (C6H12NO3S)Na, (C6H12NO3S)2Mg, and cinnamyl anthranilate 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 found in natural products at levels de- FEDERAL REGISTER of October 23, 1985. tectable by the official methodology, [50 FR 42932, Oct. 23, 1985] and have been used as artificial sweet- eners.
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(b) Food containing any added or de- Analysis of the Association of Official tectable level of cyclamate is deemed Analytical Chemists,’’ 13th Ed. (1980), to be adulterated in violation of the which is incorporated by reference. act based upon an order published in Copies may be obtained from the Asso- the FEDERAL REGISTER of October 21, ciation of Official Analytical Chemists 1969 (34 FR 17063). International, 481 North Frederick (c) The analytical methods used for Ave., suite 500, Gaithersburg, MD 20877– detecting cyclamate in food are in sec- 2504, or may be examined at the Office tions 20.162–20.172 of the ‘‘Official Meth- of the Federal Register, 800 North Cap- ods of Analysis of the Association of itol Street, NW., suite 700, Washington, Official Analytical Chemists,’’ 13th Ed. DC 20408. (1980), which is incorporated by ref- [42 FR 14659, Mar. 15, 1977, as amended at 49 erence. Copies may be obtained from FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, the Association of Official Analytical 1989] Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, § 189.155 Monochloroacetic acid. MD 20877–2504, or may be examined at (a) Monochloroacetic acid is the the Office of the Federal Register, 800 chemical chloroacetic acid, C2H3C1O2. North Capitol Street, NW., suite 700, It is a synthetic chemical not found in Washington, DC 20408. natural products, and has been pro- [42 FR 14659, Mar. 15, 1977, as amended at 49 posed as a preservative in alcoholic and FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, nonalcoholic beverages. 1989] Monochloroacetic acid is permitted in food package adhesives with an accept- § 189.140 Diethylpyrocarbonate ed migration level up to 10 parts per (DEPC). billion (ppb) under § 175.105 of this chap- (a) Diethylpyrocarbonate is the ter. The official methods do not detect chemical pyrocarbonic acid diethyl monochloroacetic acid at the 10 ppb ester, C6H10O5. It is a synthetic chem- level. ical not found in natural products at (b) Food containing any added or de- levels detectable by available method- tectable level of monochloroacetic acid ology and has been used as a ferment is deemed to be adulterated in viola- inhibitor in alcoholic and nonalcoholic tion of the act based upon trade cor- beverages. respondence dated December 29, 1941 (b) Food containing any added or de- (TC–377). tectable level of DEPC is deemed to be (c) The analytical methods used for adulterated in violation of the act detecting monochloroacetic acid in based upon an order published in the food are in sections 20.067–20.072 of the FEDERAL REGISTER of August 2, 1972 (37 ‘‘Official Methods of Analysis of the FR 15426). Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is in- § 189.145 Dulcin. corporated by reference. Copies may be (a) Dulcin is the chemical 4- obtained from the Association of Offi- ethoxyphenylurea, C9H12N2O2. It is a cial Analytical Chemists International, synthetic chemical having a sweet 481 North Frederick Ave., suite 500, taste about 250 times that of sucrose, is Gaithersburg, MD 20877–2504, or may be not found in natural products at levels examined at the Office of the Federal detectable by the official methodology, Register, 800 North Capitol Street, and has been proposed for use as an ar- NW., suite 700, Washington, DC 20408. tificial sweetener. [42 FR 14659, Mar. 15, 1977, as amended at 49 (b) Food containing any added or de- FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, tectable level of dulcin is deemed to be 1989] adulterated in violation of the act, based upon an order published in the § 189.165 Nordihydroguaiaretic acid FEDERAL REGISTER of January 19, 1950 (NDGA). (15 FR 321). (a) Nordihydroguaiaretic acid is the (c) The analytical methods used for chemical 4,4′-(2,3-dimethyltetrame- detecting dulcin in food are in sections thylene) dipyrocatechol, C18H22O4. It 20.173–20.176 of the ‘‘Official Methods of occurs naturally in the resinous
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exudates of certain plants. The com- § 189.180 Safrole. mercial product, which is synthesized, (a) Safrole is the chemical 4-allyl-1,2- has been used as an antioxidant in methylenedioxy-benzene, C H O It is foods. 10 10 2. a natural constituent of the sassafras (b) Food containing any added NDGA plant. Oil of sassafras is about 80 per- is deemed to be adulterated in viola- tion of the act based upon an order cent safrole. Isosafrole and dihydrosafrole are derivatives of saf- published in the FEDERAL REGISTER of April 11, 1968 (33 FR 5619). role, and have been used as flavoring (c) The analytical method used for compounds. detecting NDGA in food is in section (b) Food containing any added saf- 20.008(b) of the ‘‘Official Methods of role, oil of sassafras, isosafrole, or Analysis of the Association of Official dihydrosafrole, as such, or food con- Analytical Chemists International,’’ taining any safrole, oil of sassafras, 13th Ed. (1980), which is incorporated isosafrole, or dihydrosafrole, e.g., sas- by reference. Copies may be obtained safras bark, which is intended solely or from the Association of Official Ana- primarily as a vehicle for imparting lytical Chemists International, 481 such substances to another food, e.g., North Frederick Ave., suite 500, Gai- sassafras tea, is deemed to be adulter- thersburg, MD 20877–2504, or may be ex- ated in violation of the act based upon amined at the Office of the Federal an order published in the FEDERAL Register, 800 North Capitol Street, REGISTER of December 3, 1960 (25 FR NW., suite 700, Washington, DC 20408. 12412). (c) The analytical method used for [42 FR 14659, Mar. 15, 1977, as amended at 49 detecting safrole, isosafrole and FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, 1989] dihydrosafrole is in the ‘‘Journal of the Association of Official Analytical § 189.175 P–4000. Chemists,’’ Volume 54 (Number 4), (a) P–4000 is the chemical 5-nitro-2-n- pages 900 to 902, July 1971, which is in- corporated by reference. Copies are propoxyaniline, C9H12N2O3. It is a syn- thetic chemical having a sweet taste available from the Division of Food about 4000 times that of sucrose, is not and Color Additives, Center for Food found in natural products at levels de- Safety and Applied Nutrition (HFS– tectable by the official methodology, 200), Food and Drug Administration, and has been proposed for use as an ar- 200 C St. SW., Washington, DC 20204, or tificial sweetener. available for inspection at the Office of (b) Food containing any added or de- the Federal Register, 800 North Capitol tectable level of P–4000 is deemed to be Street, NW., suite 700, Washington, DC adulterated in violation of the act 20408. based upon an order published in the [42 FR 14659, Mar. 15, 1977, as amended at 42 FEDERAL REGISTER of January 19, 1950 FR 56729, Oct. 28, 1977; 47 FR 11855, Mar. 19, (15 FR 321). 1982; 54 FR 24900, June 12, 1989] (c) The analytical methods used for detecting P–4000 in food are in sections § 189.190 Thiourea. 20.177–20.181 of the ‘‘Official Methods of (a) Thiourea is the chemical Analysis of the Association of Official thiocarbamide, CH4N2S. It is a syn- Analytical Chemists,’’ 13th Ed. (1980), thetic chemical, is not found in natural which is incorporated by reference. products at levels detectable by the of- Copies may be obtained from the Asso- ficial methodology, and has been pro- ciation of Official Analytical Chemists posed as an antimycotic for use in dip- International, 481 North Frederick ping citrus. Ave., suite 500, Gaithersburg, MD 20877– (b) Food containing any added or de- 2504, or may be examined at the Office tectable level of thiourea is deemed to of the Federal Register, 800 North Cap- be adulterated under the act. itol Street, NW., suite 700, Washington, (c) The analytical methods used for DC 20408. detecting thiourea are in sections [42 FR 14659, Mar. 15, 1977, as amended at 49 20.115–20.126 of the ‘‘Official Methods of FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, Analysis of the Association of Official 1989] Analytical Chemists,’’ 13th Ed. (1980),
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which is incorporated by reference. § 189.250 Mercaptoimidazoline and 2- Copies may be obtained from the Asso- mercaptoimidazoline. ciation of Official Analytical Chemists (a) Mercaptoimidazoline and 2- International, 481 North Frederick mercaptoimidazoline both have the Ave., suite 500, Gaithersburg, MD 20877– molecular formula C3H6N2S. They are 2504, or may be examined at the Office synthetic chemicals not found in nat- of the Federal Register, 800 North Cap- ural products and have been used in the itol Street, NW., suite 700, Washington, production of rubber articles that may DC 20408. come into contact with food. (b) Food containing any added or de- [42 FR 14659, Mar. 15, 1977, as amended at 49 lectable levels of these substances is FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, deemed to be adulterated in violation 1989] of the act based upon an order pub- lished in the FEDERAL REGISTER of No- § 189.191 Chlorofluorocarbon propel- vember 30, 1973 (38 FR 33072). lants. The use of chlorofluorocarbons in § 189.280 4,4′-Methylenebis (2-chloro- human food as propellants in self-pres- analine). surized containers is prohibited as pro- (a) 4,4′-Methylenebis (2- vided by § 2.125 of this chapter. chloroanaline) has the molecular for- mula, C13H12Cl2N2. It is a synthetic [43 FR 11317, Mar. 17, 1978] chemical not found in natural products and has been used as a polyurethane Subpart C—Substances Prohibited curing agent and as a component of From Indirect Addition to food packaging adhesives and poly- Human Food Through Food- urethane resins. Contact Surfaces (b) Food containing any added or de- tectable level of this substance is § 189.220 Flectol H. deemed to be adulterated in violation of the act based upon an order pub- (a) Flectol H is the chemical 1,2- lished in the FEDERAL REGISTER of De- dihydro-2,2,4-trimethylquinoline, po- cember 2, 1969 (34 FR 19073). lymerized, C12H15N. It is a synthetic chemical not found in natural prod- § 189.300 Hydrogenated 4,4′-isopropyl- ucts, and has been used as a component idene-diphenolphosphite ester res- of food packaging adhesives. ins. (b) Food containing any added or de- (a) Hydrogenated 4,4′-isopropylidene- tectable level of this substance is diphenolphosphite ester resins are the deemed to be adulterated in violation condensation product of 1 mole of of the act based upon an order pub- triphenyl phosphite and 1.5 moles of hydrogenated 4,4′-isopropylidene- lished in the FEDERAL REGISTER of diphenol such that the finished resins April 7, 1967 (32 FR 5675). have a molecular weight in the range [42 FR 14659, Mar.15, 1977, as amended at 58 of 2,400 to 3,000. They are synthetic FR 17099, Apr. 1, 1993] chemicals not found in natural prod- ucts and have been used as anti- § 189.240 Lead solders. oxidants and as stabilizers in vinyl (a) Lead solders are alloys of metals chloride polymer resins when such that include lead and are used in the polymer resins are used in the manu- facture of rigid vinyl chloride polymer construction of metal food cans. bottles. (b) Food packaged in any container (b) Food containing any added or de- that makes use of lead in can solder is tectable levels of these substances is deemed to be adulterated in violation deemed to be adulterated and in viola- of the Federal Food, Drug, and Cos- tion of the Federal Food, Drug, and metic Act, based upon an order pub- Cosmetic Act, based upon an order pub- lished in the FEDERAL REGISTER of lished in the FEDERAL REGISTER of Sep- June 27, 1995. tember 9, 1987 (52 FR 33929). [60 FR 33109, June 27, 1995] [54 FR 7188, Feb. 17, 1989]
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§ 189.301 Tin-coated lead foil capsules used for food in a form in which the for wine bottles. food has not been chemically altered, (a) Tin-coated lead foil is composed the manufacturer or distributor of that of a lead foil coated on one or both supplement, or of the new dietary in- sides with a thin layer of tin. Tin-coat- gredient, shall submit to the Office of ed lead foil has been used as a capsule Nutritional Products, Labeling and Di- (i.e., as a covering applied over the etary Supplements (HFS–820), Center cork and neck areas) on wine bottles to for Food Safety and Applied Nutrition, prevent insect infestation, as a barrier Food and Drug Administration, 200 C to oxygen, and for decorative purposes. St. SW., Washington, DC 20204, infor- Information received by the Food and mation including any citation to pub- Drug Administration establishes that lished articles that is the basis on the use of such a capsule on wine bot- which the manufacturer or distributor tles may reasonably be expected to re- has concluded that a dietary supple- sult in lead becoming a component of ment containing such dietary ingre- the wine. dient will reasonably be expected to be (b) The capping of any bottles of wine safe. An original and two copies of this after February 8, 1996, with a tin-coat- notification shall be submitted. ed lead foil capsule renders the wine (b) The notification required by para- adulterated and in violation of section graph (a) of this section shall include: 402(a)(2)(C) of the Federal Food, Drug, (1) The name and complete address of and Cosmetic Act because lead from the manufacturer or distributor of the the capsule, which is an unsafe food ad- dietary supplement that contains a ditive within the meaning of section new dietary ingredient, or of the new 409 of the act, may reasonably be ex- dietary ingredient; pected to become a component of the (2) The name of the new dietary in- wine. gredient that is the subject of the pre- market notification, including the [61 FR 4820, Feb. 8, 1996] Latin binomial name (including the au- thor) of any herb or other botanical; PART 190—DIETARY SUPPLEMENTS (3) A description of the dietary sup- plement or dietary supplements that Subpart A [Reserved] contain the new dietary ingredient in- cluding: Subpart B—New Dietary Ingredient (i) The level of the new dietary ingre- Notification dient in the dietary supplement; and Sec. (ii) The conditions of use rec- 190.6 Requirement for premarket notifica- ommended or suggested in the labeling tion. of the dietary supplement, or if no con- ditions of use are recommended or sug- AUTHORITY: Secs. 201(ff), 301, 402, 413, 701 of the Federal Food, Drug, and Cosmetic Act gested in the labeling of the dietary (21 U.S.C. 321(ff), 331, 342, 350b, 371). supplement, the ordinary conditions of use of the supplement; SOURCE: 62 FR 49891, Sept. 23, 1997, unless (4) The history of use or other evi- otherwise noted. dence of safety establishing that the dietary ingredient, when used under Subpart A [Reserved] the conditions recommended or sug- gested in the labeling of the dietary Subpart B—New Dietary supplement, will reasonably be ex- Ingredient Notification pected to be safe, including any cita- tion to published articles or other evi- § 190.6 Requirement for premarket no- dence that is the basis on which the tification. distributor or manufacturer of the die- (a) At least 75 days before intro- tary supplement that contains the new ducing or delivering for introduction dietary ingredient has concluded that into interstate commerce a dietary the new dietary supplement will rea- supplement that contains a new die- sonably be expected to be safe. Any ref- tary ingredient that has not been erence to published information offered present in the food supply as an article in support of the notification shall be
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accompanied by reprints or photostatic agency, to determine whether they are copies of such references. If any part of substantive and whether they require the material submitted is in a foreign that the 75-day period be reset. If the language, it shall be accompanied by agency determines that the new sub- an accurate and complete English mission is a substantive amendment, translation; and FDA will assign a new filing date. FDA (5) The signature of the person des- will acknowledge receipt of the addi- ignated by the manufacturer or dis- tional information and, when applica- tributor of the dietary supplement that ble, notify the manufacturer of the new contains a new dietary ingredient. filing date, which is the date of receipt (c) FDA will acknowledge its receipt by FDA of the information that con- of a notification made under section stitutes the substantive amendment. 413 of the Federal Food, Drug, and Cos- metic Act (the act) and will notify the (e) FDA will not disclose the exist- submitter of the date of receipt of such ence of, or the information contained a notification. The date that the agen- in, the new dietary ingredient notifica- cy receives the notification submitted tion for 90 days after the filing date of under paragraph (a) of this section is the notification. After the 90th day, all the filing date for the notification. For information in the notification will be 75 days after the filing date, the manu- placed on public display, except for any facturer or distributor of a dietary sup- information that is trade secret or oth- plement that contains a new dietary erwise confidential commercial infor- ingredient shall not introduce, or de- mation. liver for introduction, into interstate (f) Failure of the agency to respond commerce the dietary supplement that to a notification does not constitute a contains the new dietary ingredient. finding by the agency that the new die- (d) If the manufacturer or distributor tary ingredient or the dietary supple- of a dietary supplement that contains a ment that contains the new dietary in- new dietary ingredient, or of the new gredient is safe or is not adulterated dietary ingredient, provides additional under section 402 of the act. information in support of the new die- tary ingredient notification, the agen- [62 FR 49891, Sept. 23, 1997, as amended at 66 cy will review all submissions per- FR 17359, Mar. 30, 2001] taining to that notification, including responses made to inquiries from the PARTS 191–199 [RESERVED]
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A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabet- ical 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 sepa- rately and revised annually. Material Approved for Incorporation by Reference Table of CFR Titles and Chapters Alphabetical List of Agencies Appearing in the CFR Redesignation Table 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 addi- tions 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). 573
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National Academy Press 2101 Constitution Ave. NW., Box 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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Food and Drug Administration, Office of Premarket Approval, Center for Food Safety and Applied Nutrition (HFS–215) 200 C St. SW, Washington DC 20204 Absorptivity Methods ‘‘Determination of Softening Point (Drop Meth- 178.3610(a) od)’’ Appendix A–2 ‘‘Determination of Unsaturation of Resin 1977’’ Appendix A–3. 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’’.
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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) VII Advisory Commission on Intergovernmental Relations (Parts 1700—1799) 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)
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XXV Department of the Interior (Part 3501) XXVI Department of Defense (Part 3601) 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) 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) 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—[Reserved]
Title 7—Agriculture
SUBTITLE A—OFFICE OF THE SECRETARY OF AGRICULTURE (PARTS 0—26) SUBTITLE B—REGULATIONS OF THE DEPARTMENT OF AGRICULTURE
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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) XIII Northeast Dairy Compact Commission (Parts 1300—1399) 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) 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) XXXI Office of Environmental Quality, Department of Agriculture (Parts 3100—3199) XXXII Office of Procurement and Property Management, Department of Agriculture (Parts 3200—3299)
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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 Immigration and Naturalization Service, Department of Justice (Parts 1—599)
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)
Title 11—Federal Elections
I Federal Election Commission (Parts 1—9099)
Title 12—Banks and Banking
I Comptroller of the Currency, Department of the Treasury (Parts 1—199)
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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 (Parts 400—499) V Emergency Oil and Gas Guaranteed Loan Board (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)
Title 15—Commerce and Foreign Trade
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)
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IV Foreign-Trade Zones Board, Department of Commerce (Parts 400—499) VII Bureau of Export Administration, 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) VIII Susquehanna River Basin Commission (Parts 800—899) XIII Tennessee Valley Authority (Parts 1300—1399)
Title 19—Customs Duties
I United States Customs Service, Department of the Treasury (Parts 1—199) II United States International Trade Commission (Parts 200—299) III International Trade Administration, Department of Commerce (Parts 300—399)
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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) 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) XIII Board for International Broadcasting (Parts 1300—1399) 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)
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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) 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—999) 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)
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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— 799)
Title 27—Alcohol, Tobacco Products and Firearms
I Bureau of Alcohol, Tobacco and Firearms, Department of the Treasury (Parts 1—299)
Title 28—Judicial Administration
I Department of Justice (Parts 0—199) 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)
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)
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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 Pension and Welfare Benefits 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) VI Bureau of Mines, Department of the Interior (Parts 600—699) 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)
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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 Transportation (Parts 1—199) II Corps of Engineers, Department of the Army (Parts 200—399) 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) VII Office of Educational Research and Improvement, Department of Education (Parts 700—799) XI National Institute for Literacy (Parts 1100—1199) SUBTITLE C—REGULATIONS RELATING TO EDUCATION XII National Council on Disability (Parts 1200—1299)
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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)
Title 37—Patents, Trademarks, and Copyrights
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—799) 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)
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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, 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) 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 from a Non-Federal Source for Travel Expenses (Parts 304–1—304–99)
Title 42—Public Health
I Public Health Service, Department of Health and Human Serv- ices (Parts 1—199) IV Health Care Financing Administration, 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)
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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—10005)
Title 44—Emergency Management and Assistance
I Federal Emergency Management Agency (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 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)
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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 Transportation (Parts 1—199) II Maritime Administration, Department of Transportation (Parts 200—399) III Coast Guard (Great Lakes Pilotage), Department of Transpor- tation (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) 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 Ben- efits 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)
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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) 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) 54 Defense Logistics Agency, Department of Defense (Part 5452) 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 Transportation (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)
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XI Bureau of Transportation Statistics, Department of Transpor- tation (Parts 1400—1499)
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) 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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CFR Title, Subtitle or Agency Chapter Administrative Committee of the Federal Register 1, I Advanced Research Projects Agency 32, I Advisory Commission on Intergovernmental Relations 5, VII 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 Alcohol, Tobacco and Firearms, Bureau of 27, I 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 Architectural and Transportation Barriers Compliance Board 36, XI
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At 53 FR 24668, June 29, 1988, 21 CFR part 193 was redesignated as 40 CFR part 185. The following table shows the relationship of the regulations under their as- signed section numbers in 21 CFR part 193 prior to thispublication, and their re- designations as reflected in new 40 CFR part 185.
Old section New section Old section New section
193.10 185.100 193.270 185.3900 193.15 185.150 193.275 185.3950 193.20 185.200 193.277 185.4000 193.25 185.250 193.280 185.4025 193.30 185.350 193.285. 185.4150 193.40 185.500 193.290 185.4200 193.43 185.600 193.300 185.4250 193.45 185.650 193.310 185.4300 193.50 185.700 193.320 185.4500 193.60 185.750 193.323 185.4400 193.65 185.1150 193.324 185.4450 193.80 185.410 193.325 185.4600 193.83 185.800 193.330 185.4650 193.85 185.1000 193.331 185.4700 193.90 185.1200 193.340 185.4800 193.97 185.1300 193.350 185.4850 193.98 185.1250 193.360 185.4900 193.99 185.3300 193.370 185.5000 193.100 185.1450 193.375 185.5100 193.105 185.1500 193.380 185.5150 193.130 185.1650 193.390 185.5200 193.135 185.1700 193.400 185.5350 193.137 185.1850 193.410 185.1550 193.140 185.1900 193.418 185.5450 193.142 185.1750 193.420 185.5475 193.150 185.2225 193.430 185.1350 193.151 185.2250 193.440 185.5900 193.152 185.2150 193.450 185.5750 193.156 185.2200 193.460 185.6300 193.160 185.2500 193.462 185.4550 193.170 185.2600 193.463 185.2950 193.180 185.2650 193.464 185.5300 193.186 185.2700 193.465 185.1800 193.190 185.2750 193.466 185.3250 193.200 185.2850 193.467 185.3650 193.210 185.2900 193.468 185.4950 193.212 185.3000 193.470 185.5550 193.220 185.3450 193.471 185.1050 193.225 185.3475 193.472 185.1100 193.230 185.3480 193.473 185.300 193.235 185.3500 193.475 185.4100 193.236 185.3550 193.476 185.5950 193.240 185.3600 193.477 185.4350 193.250 185.3700 193.479 185.2800 193.251 185.425 193.480 185.2275 193.253 185.3750 193.481 185.5250 193.255 185.3800 193.520 185.7000 193.260 185.3850
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1986 21 CFR—Continued 51 FR Page 21 CFR 51 FR Chapter I—Continued Page 176.300 (c) table amended...... 19059 Chapter I (d) amended ...... 43734 Mandatory compliance date 1–1– 177.1310 (a) and (b) revised; (c) re- 89...... 34085 designated as (d); new (c) 172.210 (b)(2) table amended ...... 2693 added...... 19060 172.515 (b) amendment confirmed; 177.1315 (b) revised ...... 22929 request for deferral denied ...... 37909 177.1500 (a)(10) revised; (b) table 172.804 (c) (8) and (9) added ...... 43000 amended...... 33250 (c)(10) added...... 43001 177.1520 (b) table amended ...... 43191 (c)(5)(ii) amended; (c)(11) added (a)(3)(i)(b) and (c) amended; ...... 43002 (a)(3)(i)(d) added ...... 45315 172.834 Technical correction...... 1495 177.1630 (e)(4) amended ...... 3772 172.846 Introductory text cor- 177.1655 Added ...... 882 rected...... 1495, 3333 (b) table and (d) corrected ...... 4165 172.859 (a) amended; (b)(10) and 177.1810 (b) table and (c)(3) re- (11) added...... 40161 vised...... 16828 172.886 (c)(2) revised ...... 19544 Technical correction ...... 18774 173.5—173.75 (Subpart A) Heading 177.2500 Removed...... 883 revised ...... 11719 178 Authority citation revised; 173.45 Added ...... 5315 section authority citations re- 173.60 Technical correction ...... 1495 moved ...... 19544 173.75 Added ...... 11720 Authority citation corrected...... 43120 175 Authority citation revised; 178.1005 (e)(1) revised ...... 45881 section authority citations re- 178.1010 (b)(29) and (c)(24) moved ...... 19545 added ...... 7437 175.105 (c)(5) table amended ...... 5316, (b)(30) and (c)(25) added ...... 7438 19545, 30059–60, 31099, 33889 (b)(31) and (c)(26) added...... 33892 Technical correction...... 1495, (b)(33) and (c)(28) added...... 47226 6520, 43120 178.2010 (b) table amended ...... 5317, 175.250 (a) amended; (b)(1) re- 12608, 19061, 29462, 31100, 32212, vised...... 47010 35512, 47012 175.300 (b)(3)(xxxi) amended...... 4312 (b) table corrected...... 15763, 39372 176.170 (b)(2) table amended...... 881, Technical correction...... 1495, 6520 28546, 47011 178.3130 (b) table amended ...... 28932 Technical correction...... 1495 178.3297 (e) table amended...... 7552, 19168 176.180 (b)(2) table amended...... 16167, (e) table corrected ...... 23535 17012, 47011 178.3400 (c) table amended ...... 31763
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21 CFR—Continued 51 FR 21 CFR—Continued 51 FR Page Page Chapter I—Continued Chapter I—Continued Technical correction ...... 39747 193.186 (b) table amended ...... 31325 178.3570 (a)(3) table amended...... 7552 193.450 Revised ...... 46617 178.3710 (f) added ...... 19545 193.468 (c) added ...... 28224 178.3740 (b) table amended ...... 47011 178.3770 (c) added...... 33895 1987 179 Authority citation revised ...... 13398 179.21 Authority citation re- 21 CFR 52 FR Page moved ...... 13398 179.22 Removed...... 13398 Chapter I 179.24 Removed...... 13398 172.210 (b)(4) table amended...... 18911 179.25 Added ...... 13399 172.859 (a) amended ...... 10883 179.26 Added ...... 13399 173.357 (a)(2) table amended...... 39512 179.45 Authority citation re- 175.105 (c)(5) table amended...... 10884, moved ...... 13398 12380, 27800, 29180 182 Authority citation revised .....16830, (c)(5) table corrected ...... 19857 25025 175.300 (b)(3)(xxxii) amended...... 41987 176.170 (b)(2) table amended.....530, 19724 182.70 Amended...... 16830, 27171 (a)(5) table amended...... 3604, Effective date corrected ...... 18774 17553, 29667, 43058, 46746 182.90 Amended...... 39372 Technical correction...... 6649 182.1366 Removed...... 27171 177 Authority citation revised .....33803, 182.3616 (c) revised ...... 25025 39635 Effective date corrected ...... 25198 177.1040 (c) table amended ...... 33803 Technical correction ...... 26876 177.1390 Heading revised ...... 33575 182.3637 (c) revised ...... 25025 177.1395 Added ...... 33575 Effective date corrected ...... 25198 Technical correction ...... 36863 Technical correction ...... 26876 177.1430 Revised ...... 11641 182.3739 (c) revised ...... 25025 177.1500 (a)(12) added; (b) table Effective date corrected ...... 25198 amended...... 26667 Technical correction ...... 26876 Technical correction ...... 28067 182.3766 (c) revised ...... 25025 (a)(4) revised; (b) table amended Effective date corrected ...... 25198 ...... 33575 Technical correction ...... 26876 (a)(13) and (c)(5) added; (b) table 182.3798 (c) revised ...... 25026 amended ...... 39635 Effective date corrected ...... 25198 (b) table corrected ...... 42760 Technical correction ...... 26876 177.1520 (b) table amended ...... 23804 182.3862 (c) revised ...... 25026 177.1555 Added ...... 35540 Effective date corrected ...... 25198 177.1630 (e)(4)(i) amended ...... 32917 Technical correction ...... 26876 177.1660 (c)(1) amended...... 20069 184 Authority citation cor- 177.2470 (a) revised; (b)(1) amend- rected ...... 1495 ed...... 4493 184.1157 Added ...... 27173 177.2550 (a) revised ...... 29668 184.1318 Added ...... 33896 177.2600 (c)(4)(iii) amended...... 35910 184.1366 (c), (d), and (e) revised ...... 27172 178.1005 (d) revised ...... 26146 186 Authority citation revised; 178.1010 (b)(32) and (c)(27) section authority citations re- added...... 409 moved ...... 16830 (b)(34) and (c)(29) added...... 29842 186.1557 Added ...... 16830 (c)(29) corrected...... 34047 Effective date corrected ...... 18774 178.2010 (b) table amended; eff. 4– 186.1770 Added ...... 39372 2–87 ...... 6324 186.1771 Added ...... 39372 (b) table amended ...... 20070, 189.113 Addition confirmed; re- 22301, 30150, 33930, 35541, 35911, quest for deferral denied ...... 37909 37446, 43059, 43323 193.35 Removed...... 25686 Technical correction ...... 24090 193.110 Removed ...... 46617 (b) table corrected ...... 26764 193.120 Removed ...... 46617 178.3295 Table amended...... 30920 193.137 Added ...... 11437 178.3910 (a)(4)(i)(a) amended...... 10223
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21 CFR—Continued 52 FR 21 CFR—Continued 53 FR Page Page Chapter I—Continued Chapter I—Continued 179.22 Petitions for deferral of ef- (c)(14) added...... 20840 fective date denied ...... 5450 (c)(15) added...... 20841 179.24 Petitions for deferral of ef- (c) (16) and (17) added ...... 20842 fective date denied ...... 5450 Technical correction ...... 23340 179.25 Petitions for deferral of ef- (c)(18) added...... 40879 fective date denied ...... 5450 (b) revised...... 51273 179.26 Petitions for deferral of ef- 172.811 Added ...... 21632 fective date denied ...... 5450 172.859 (c)(3) revised ...... 22294 182.8245 Removed...... 25211 (a) amendment and (b) (10) and 184.1245 Added ...... 25211 (11) additions in 51 FR 40161 re- 184.1259 (a) revised; (b) (8) and (9) published ...... 22297 revised ...... 47920 Technical correction...... 26559, 36785 (a)(2) corrected ...... 48905 173 Authority citation revised .....15199, 184.1287 Added ...... 25976 39456 184.1328 Added ...... 42430 173.73 Added ...... 39456 184.1639 Added ...... 10886 (a)(2) corrected...... 43319, 49823 184.1768 Added ...... 10886 173.310 (c) table amended...... 15199 193.98 Added ...... 29009 (c) table corrected ...... 18194 (b) corrected ...... 31846 175.105 (c)(5) table amended...... 29454, 193.137 Existing text designated 32606, 52131 as (a); (b) added ...... 17941 175.300 (b)(3)(xxxiii) amended...... 34279 193.142 Heading and text nomen- 176.170 (a)(5) table corrected ...... 97 clature change...... 32293 (a)(5) table amended ...... 8620, 28636, 193.253 Table amended ...... 10562 34045, 50211, 50952 193.277 (d) added ...... 41418 177.1310 (b) revised ...... 44009 (d) corrected ...... 42760 177.1330 (c) amended...... 44009 193.410 Revised ...... 27543 177.1390 (c)(3)(i)(a) (1) and (2) and 193.430 Heading and text nomen- (b) (1) and (2) amended; clature change...... 32293 (c)(2)(vi) and (3)(i)(b)(3) 193.472 Added ...... 10563 added...... 39084 193.473 Added ...... 17942 177.1395 (b)(4) table amended ...... 19773 Technical correction ...... 23137, 177.1500 (a)(14) added; (b) table 23916, 34903 amended; (c)(5) redesignated as 193.475 Added ...... 43324 (c)(5)(i); (c)(5)(ii) added ...... 19773 193.476 Added ...... 39222 177.1580 (b) table amended ...... 29656 177.1990 (c)(3) and (e) revised...... 47185 1988 177.2550 (a) revised ...... 31835 21 CFR 53 FR (a)(3) added ...... 32215 Page Technical correction ...... 36391 Chapter I 177.2910 Introductory text re- Uniform compliance date 1–1–91 ...... 44861 vised; (a) redesignated as (a)(1) 170 Authority citation revised ...... 16546 and revised; new (a)(2) 170.3 (f) revised ...... 16546 added...... 17925 170.30 (c) redesignated as (c)(1); 178.1005 (e)(1) revised ...... 47186 new (c)(1) amended; (c)(2) 178.1010 (b)(35) and (c)(30) added...... 16546 added...... 31837 170.35 (c)(1) introductory text re- 178.2010 (b) table amended ...... 15200, vised; OMB number...... 16547 18087, 29657, 32375, 47526, 49551, 172.133 Added ...... 41329 52133 Technical correction ...... 49638 178.3295 Table amended...... 30049 172.800 Added ...... 28382 Technical correction ...... 18194 172.804 (c) (8), (9), (10), and (11) re- 178.3297 (e) table amended ...... 52132 quest for stay denied and effec- 178.3570 (a)(3) table amended...... 8441, tive date confirmed ...... 6595 44397 (c)(13) added...... 20838 179.26 (c)(4) amended...... 12757 (c)(12) added...... 20839 Effective date corrected ...... 16615
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21 CFR—Continued 53 FR 21 CFR—Continued 53 FR Page Page Chapter I—Continued Chapter I—Continued (b) table amended ...... 53209 193.152 (c) removed ...... 8874 182 Authority citation revised ...... 16864 193.156 (b), (c) and (d) removed...... 8874 182.1 (a) amended ...... 44875 193.186 (a) table amended ...... 5367 182.90 Amended...... 16864, 44876 193.215 Removed...... 9434 182.8301 Removed...... 16864 193.219 Removed...... 9434 182.8304 Removed...... 16864 193.235 (b) removed ...... 9434 182.8306 Removed...... 16864 193.277 (c) removed ...... 8874 182.8308 Removed...... 16864 193.284 Removed...... 9434 182.8311 Removed...... 16864 193.301 Removed...... 9434 182.8315 Removed...... 16864 193.400 Revised ...... 9434 182.8375 Removed...... 16864 193.415 Removed...... 9434 184.1259 Technical correction ...... 4384 193.430 Revised ...... 23389 184.1296 Added ...... 16864 193.468 Revised ...... 8874 184.1297 Added ...... 16864 193.469 Removed...... 8874 184.1298 Added ...... 16865 193.473 Amended ...... 23107 184.1301 Added ...... 16865 193.477 Added ...... 21, 12943 184.1304 Added ...... 16865 193.479 Added ...... 234 (a) and (d) corrected ...... 20939 Amended ...... 23388 184.1307 Added ...... 16865 193.480 Added; eff. to 6–30–89...... 23386 184.1307a Added...... 16865 193.481 Added ...... 23387 184.1307b Added...... 16865 184.1307c Added...... 16866 184.1307d Added...... 16866 1989 184.1308 Added ...... 16866 21 CFR 54 FR (b) corrected ...... 20939 Page 184.1311 Added ...... 16866 Chapter I 184.1315 Added ...... 16866 170 Authority citation revised; 184.1375 Added ...... 16867 sectional authority citations 184.1538 Added ...... 11250 removed ...... 39634 Technical correction ...... 16837 170.3 (n) and (o) introductory text 184.1555 (c)(1) amended...... 52682 amended...... 24896 184.1854 Added ...... 44876 170.6 (e) amended ...... 24896 184.1857 Added ...... 44876 170.38 (b)(3) amended...... 24896 184.1859 Added ...... 44876 171 Authority citation revised ...... 39634 184.1865 Added ...... 44876 172 Authority citation revised; 186.1300 Added ...... 16867 sectional authority citations (b)(2) corrected ...... 20939 removed ...... 39634 184.1330 (c) table amended...... 5766 172.105 (b) (1), (2), and (3) amend- 186.1374 Added ...... 16867 ed ...... 24896 (b)(2) corrected ...... 20939 172.250 (b)(3) footnote 1 amend- 193 Redesignated as 40 CFR Part ed ...... 24896 185 ...... 24666 172.320 (b)(2), (c)(1), and (d) Correctly redesignated as 40 amended...... 24897 CFR Part 185...... 26131 172.340 (b) introductory text foot- 193.15 (b) removed...... 8874 note 1 amended ...... 24897 193.70 Removed ...... 9434 172.372 (d) amended ...... 24897 193.84 Removed ...... 8874 172.385 (c)(1) amended ...... 24897 193.85 (c) removed...... 9434 172.510 (b) table footnote 1 amend- 193.87 Removed ...... 8874 ed ...... 24897 193.98 (a) added ...... 1917 172.515 (b) amended ...... 7402 (c) added ...... 18837 172.804 (c)(19) added...... 23647 193.100 Revised ...... 9434 (c)(20) added...... 23647 193.137 (b) amended ...... 20308 (c)(21) added...... 31333 193.142 Introductory text re- 172.859 (b) (1), (5), and (9) amend- vised...... 23389 ed ...... 24897 193.145 Removed...... 9434 172.860 (c) (1) and (2) amended ...... 24897
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21 CFR—Continued 54 FR 21 CFR—Continued 54 FR Page Page Chapter I—Continued Chapter I—Continued 172.864 (b)(3) footnote 1 amend- (a)(3)(i)(c) redesignated as ed ...... 24897 (a)(3)(i)(c)(1); (a)(3)(i)(c)(2) 172.878 (a)(3) amended ...... 24897 added; (c) table amended; 172.882 (a) amended ...... 24897 (d)(7) revised...... 49079 172.886 (b) footnote 1 amended ...... 24897 (c) table corrected ...... 51342 173 Authority citation revised; 177.1550 (e) footnote 1 amended...... 24898 sectional authority citations 177.1630 (j) added ...... 15750 removed ...... 39634 Technical correction ...... 19283 173.60 (b)(3) amended...... 24897 (e)(4)(iii) amended ...... 24898 173.145 (b) footnote 1 amended ...... 24897 177.1635 (c)(1) amended...... 24898 177.1810 (c)(2)(ii) amended ...... 24898 173.160 (b)(1) footnote 1 and (2) 177.1820 (c)(3) amended...... 24898 amended...... 24897 177.1990 (c)(1) amended...... 24898 173.165 (b)(2) amended ...... 24897 177.2210 (b)(3) amended...... 24898 173.310 (c) table amended...... 31012 177.2420 (b) table amended ...... 48858 173.395 (d) amended ...... 24897 177.2450 (b) (1), (2), and (3) amend- 174 Authority citation revised ...... 39634 ed ...... 24898 175 Authority citation revised ...... 39634 (a) and (b) revised; (c) introduc- 175.105 (c)(5) table amended...... 15750, tory text amended ...... 43170 24554, 50500 177.2470 (c)(2) amended...... 24898 175.300 (b)(3)(xix) amended...... 24897 177.2480 (d)(2)(i) amended ...... 24898 (b)(3)(xxxiii) amended...... 30732, 177.2490 (a) introductory text 47765, 47766 amended...... 24898 (b)(3)(vii)(e) added...... 48858 177.2600 (c)(4)(iv) heading revised 176 Authority citation revised ...... 39634 and text amended...... 35638 176.170 (a)(5) table amended...... 19363, (c)(4)(i) amended...... 38969 38968 178 Authority citation revised ...... 39634 Authority citation removed ...... 39634 178.1005 (e)(1) table amended...... 5604, (d)(3) introductory text amend- 13167 ed...... 24897 (e)(1) table corrected ...... 6365 176.180 (b)(2) table amended...... 10630, 178.1010 (b)(36) and (c)(31) 13881, 14075 added...... 21621 Technical correction ...... 13606 (b)(38) and (c)(33) added...... 21939 176.210 (d)(3) amended ...... 24897 (b)(36) corrected...... 23739 176.300 (c) table revised ...... 18103 Technical correction ...... 24789 177 Authority citation revised; (b)(16) amended...... 24898 sectional authority citations (b)(37) and (c)(32) added...... 31014 removed ...... 39634 178.2010 (b) table amended ...... 6125, 9775, 177.1020 (c)(2) and (d)(2) amend- 13878, 17705, 39357 Technical correction ...... 42886 ed ...... 24897 178.2650 Introductory text and (a) 177.1030 (c)(2) and (d)(2) amend- introductory text revised; ed ...... 24898 (a)(7) and (b)(1)(iii) added...... 6658 177.1050 (b) table, (c) (2) and (3), (d) (b)(1)(ii) amended ...... 24898 introductory text, and (e)(4) 178.3295 Table amended...... 12432 amended...... 24898 Table corrected ...... 14734 177.1060 Added ...... 20382 178.3297 (e) table amended ....21053, 35875 177.1330 (e)(4) amended...... 24898 (c) amended ...... 24898 177.1350 (d) (1), (3), and (e)(1) re- 178.3480 (c) introductory text vised...... 35874 amended...... 24898 177.1390 (c)(3)(i)(a)(1) amended ...... 24898 178.3570 (a)(3) table amended ...... 31519 177.1480 (b)(2) introductory text 178.3610 (a) amended...... 24898 amended...... 24898 178.3620 (b)(1)(ii) and (c)(3) foot- 177.1500 (b) table amended ...... 29019 note 1 amended ...... 24898 177.1520 (b) table amended ...... 10632 178.3690 (b)(4) amended...... 24898 (a)(5) added; (c) table amended 178.3770 (a)(4) footnote 1 amend- ...... 40383 ed ...... 24898
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21 CFR—Continued 54 FR 21 CFR—Continued 54 FR Page Page Chapter I—Continued Chapter I—Continued 178.3780 (b)(1) amended...... 24899 184.1979b (b)(1) introductory text 178.3870 (f)(6)(iv) amended...... 24899 footnote 2 amended...... 24899 178.3910 (a)(2) table amended...... 6124 184.1979c (b)(1) introductory text Technical correction...... 7920 footnote 2 amended...... 24899 (a)(4)(iii) footnote 1 and (b) in- 186 Authority citation revised ...... 39635 troductory text amended...... 24899 189 Authority citation revised; 179 Authority citation revised ...... 39634 sectional authority citations 179.26 Technical correction ...... 6475 removed ...... 39635 Regulation at 53 FR 53209 effec- 189.1 (c) amended ...... 24899 tive date confirmed ...... 32335 189.110 (c) amended ...... 24899 179.45 (c) and (d) redesignated as 189.130 (c) amended ...... 24899 (d) and (e); new (c) added ...... 7405 189.135 (c) amended ...... 24899 (b)(6) introductory text amend- 189.145 (c) amended ...... 24899 ed...... 24899 189.155 (c) amended ...... 24899 180 Authority citation revised ...... 39635 189.165 (c) amended ...... 24900 180.1 Authority citation re- 189.175 (c) amended ...... 24900 moved ...... 39634 189.180 (c) amended ...... 24900 180.22 (a) introductory text, (b), 189.190 (c) amended ...... 24900 (e), and (f) (1) and (2) amend- 189.300 Added ...... 7188 ed ...... 24899 197 Authority citation revised ...... 39635 181 Authority citation revised ...... 39635 181.1 Authority citation re- 1990 moved ...... 39635 21 CFR 55 FR 181.32 (b) introductory text Page amended...... 24899 Chapter I 182 Authority citation cor- 172.665 Added ...... 39614 rected ...... 6365 173.310 (c) table amended...... 12172 Authority citation revised ...... 39635 173.342 Added ...... 8913 182.60 Amended ...... 7402 173.357 (a)(2) table amended...... 12172 182.90 Amended ...... 7402 175.105 (c)(5) table amended...... 10235, 182.1324 Removed ...... 7402 30215 182.1901 Removed ...... 7402 176.170 (a)(5) table amended ...1673, 10236 182.4101 Removed ...... 7402 (b)(2) table amended ...... 13520 182.4505 Removed ...... 7402 176.300 (c) table amended...... 31825 182.4521 Removed ...... 7402 177.1210 (b)(5) table amended ...... 34555 184 Authority citation revised ...... 39635 177.1350 (a)(6) added...... 18595 184.1101 Added ...... 7403 177.1520 (b) table amended ...... 18596 (a) revised; (e) added; eff. 5–1–89 (c) table amended ...... 31826 ...... 13168 (b) table corrected ...... 19701 Effective date and (e) corrected (b) table amended ...... 34710 ...... 18382 177.1635 (e) revised ...... 52989 184.1323 Added ...... 7403 177.2550 (d)(1) revised; (d)(2) and 184.1324 Added ...... 7403 (3) redesignated as (d)(3) and 184.1408 (b)(1) amended...... 24899 (4); (a)(4) and new (d)(2) 184.1472 Added ...... 38223 added ...... 8139 184.1505 Added ...... 7403 177.2600 (c)(4)(i) amended ...... 34555 184.1521 Added ...... 7404 178 Technical correction...... 50279 184.1854 (b) corrected...... 228 178.1005 (e)(1) table amended ...... 47055 184.1859 (a) corrected...... 228 178.2010 (b) table amended ...13521, 18597, 184.1901 Added ...... 7404 22901, 30216 184.1903 Added ...... 7404 178.3280 (b) table amended ...... 8914 (c)(2) corrected ...... 10482 178.3295 Table amended...... 52990 184.1979 (b)(1) introductory text 178.3297 (e) table amended.....3585, 12344, footnote 2 amended...... 24899 18721, 31827 184.1979a (b)(1) introductory text 178.3570 (a)(3) table amended ...... 30218, footnote 2 amended...... 24899 47323
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21 CFR—Continued 55 FR 21 CFR—Continued 56 FR Page Page Chapter I—Continued Chapter I—Continued 178.3700 (a) and (d) amended...... 12172 178.3295 Table amended ...... 1085 178.3770 Heading, introductory 178.3297 (c) revised; (d) added; (e) text, (a) introductory text, (b) table amended ...... 42933 introductory text, (c) intro- (e) table corrected ...... 65782 ductory text and (c)(1) amend- 178.3400 (c) table amended ...... 41457 ed; (d) added...... 28020 178.3550 Removed...... 42935 179 Authority citation revised...... 9079 178.3570 (a)(3) table amended ...... 41456 179.26 (c)(4) removed ...... 14415 178.3910 (a)(2) table amended ...... 55456 (c)(4) correctly removed ...... 18227 178.3970 Removed...... 42935 (b) Table revised ...... 18544 Technical correction ...... 19701 1992 182.3616 (c) revised; eff. 4–16–90 ...... 9832 182.3637 (c) revised; eff. 4–16–90 ...... 9832 21 CFR 57 FR Page 182.3739 (c) revised; eff. 4–16–90 ...... 9832 182.3766 (c) revised; eff. 4–16–90 ...... 9833 Chapter I 182.3798 (c) revised; eff. 4–16–90 ...... 9833 172 Hearing denied ...... 3698 182.3862 (c) revised; eff. 4–16–90 ...... 9833 Technical correction...... 9472 184.1498 Added ...... 6391 172.225 Revised ...... 12711 Technical correction ...... 10030 172.270 Added ...... 12711 184.1685 Revised ...... 10935 172.665 (a) amended; (e) revised...... 55445 172.800 (c)(7) added ...... 57961 172.804 (c)(22) added ...... 3702 1991 (c)(1) and (3) revised; (e)(4) added 21 CFR 56 FR ...... 3703 Page (c)(13) revised ...... 3704 Chapter I 172.861 Heading corrected...... 2814 172.540 Added ...... 6968 172.880 Request for stay and hear- 172.712 Removed ...... 42686 ing denied ...... 6667 Technical correction ...... 46667 172.892 (h) amended; (i) added ...... 54700 172.861 Added ...... 66970 173.320 (b) introductory text 173.25 (a)(20) and (b)(5) added; (b) amended; (b)(6) added ...... 8065 introductory text and (d) re- 175.105 (c)(5) table amended...... 10810 vised...... 16268 176.170 (a)(5) table amended ...... 3123 173.400 Added ...... 42686 (a)(5) table amended ...... 10616 Technical correction ...... 46667 Regulation at 57 FR 10616 effec- 175.105 (c)(5) table amended...... 14316 tive date corrected ...... 11797 175.300 (b)(3)(xxvi) revised...... 42932 (b)(2) table amended ...... 20200 175.320 (b)(3) table amended...... 49674 (a)(5) table amended ...... 23949, 34867 176 Technical correction ...... 2585 176.210 (d)(3) amended ...... 31313 176.170 (a)(5) table amended ...... 18, 368 177.1312 Added ...... 32422 (b)(2) table amended ...... 19930, 49674 177.1345 Added ...... 43399 (b)(1) and (2) table amended ...... 42932 177.1380 (a)(4) added; (b) re- (b)(2) table corrected ...... 65782 vised...... 185 177.1350 (a)(3) revised ...... 42932 177.1395 (b)(4) table amended ...... 43399 177.1460 (b) table amended ...... 42933 177.1520 (c) table amended ...... 10616 177.1520 (b) table amended ....21447, 42933 Regulation at 57 FR 10616 effec- (b) table corrected ...... 25446 tive date corrected ...... 11797 177.1680 (a)(2) and (b) table 177.1585 Added ...... 3940 amended...... 15278 Technical correction...... 5294 Technical correction ...... 22910 177.1632 Added ...... 3125 (b) table amended ...... 42933 177.2600 (c)(4)(i) amended...... 3128 177.2250 (d) revised ...... 42933 178 Technical correction...... 37867 177.2260 (d)(5) revised ...... 42933 178.1005 (e)(1) table amended ...... 32423 177.2600 (c)(4)(vi) revised ...... 42933 178.1010 (b)(39) and (c)(34) 177.2800 (d)(5) table amended ...... 42933 added...... 11682 178.2010 (b) table amended .....1084, 43698 (b)(40) and (c)(35) added...... 35463 178.3130 (b) table amended ...... 41457 (b)(41) and (c)(36) added...... 43614
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21 CFR—Continued 57 FR 21 CFR—Continued 58 FR Page Page Chapter I—Continued Chapter I—Continued (b)(42) and (c)(37) added...... 54701 (d)(3)(ii) introductory text re- 178.2010 (b) table amended ....2019, 10811, vised; (d)(3)(ii)(e) through (i) 10992 added ...... 21258 table amended...... 10992, 18081, 48724, 177.1810 (b) table amended ...... 65546 48980 177.2600 (c)(4)(ii)(b) amended ...... 60554 178.3690 (a) revised; (b)(1) amend- 177.2910 Introductory text re- ed ...... 18082 vised; (a)(3) added ...... 48599 178.3910 (a)(2) table amended ...... 23952 178 Authority citation revised ...... 37855 182.8201 Removed; eff. 4–30–92 ...... 10813 178.1010 (b)(41) corrected ...... 17099 182.8455 Removed; eff. 4–30–92 ...... 10813 (b)(43) added; (c)(19) amended ...... 57555 178.2010 (b) table amended ....17515, 37855 182.8628 Removed; eff. 4–30–92 ...... 10813 178.3010 Table amended...... 64895 184.1201 Added; eff. 4–30–92...... 10813 178.3130 (b) table amended ...... 57556 184.1505 (c) introductory text and 178.3297 (e) table amended ...... 17514 (1) amended ...... 10616 (c) and (e) table amended; (d) re- Regulation at 57 FR 10616 effec- vised ...... 67323 tive date corrected ...... 11797 178.3400 (c) table amended ...... 26687 184.1685 (a)(3) added ...... 6479 178.3770 (a)(2), (3), (b)(2), (3), (d)(2) 184.1924 Added ...... 60473 and (3) amended ...... 17512 178.3910 (b)(2) table amended ...... 17513 1993 184.1685 (a)(4) added...... 27202 Technical correction ...... 30220 21 CFR 58 FR 186.1551 (a) amended...... 17099 Page 189.220 (a) amended ...... 17099 Chapter I Chapter I Technical correc- 1994 tion ...... 17085 172 Authority citation revised .....48598, 21 CFR 59 FR 52221 Page 172.120 (b)(1) table amended...... 52222 Chapter I 172.133 Introductory text, (b) and 172.133 Introductory text, (b) and (c)(2) revised ...... 6091 (c)(2) revised ...... 5319 172.490 (a) ameended ...... 17098 172.320 (b)(1) amended ...... 14550 172.804 (c)(10) and (d) revised...... 19771 172.800 (c)(9), (10) and (11) (c)(5)(ii) and (6) revised; (c)(8), added...... 61540 (11) and (12) removed...... 21097 (c)(1) revised; (c)(2) removed ...... 61543 (d) revised...... 21098 (c)(8) added ...... 61545 (c)(23) added...... 21099 172.811 (b) revised...... 24924 172.841 (b), (c), and (d) redesig- (c)(18) revised...... 48598 nated as (c), (d), and (e); new (b) 172.892 (d) table amended ...... 21100 added; new (c) revised...... 37421 175 Authority citation revised ...... 39655 172.888 (a) revised...... 10986 175.105 (c)(5) table amended...... 21256, 173.21 Added ...... 15623 21257, 39656 173.170 Added ...... 26711 176 Authority citation revised ...... 51996 173.357 (a)(2) table amended...... 36937 Authority citation corrected...... 65284 175.105 (c)(5) table amended...... 47080 176.170 (a)(5) table amended...... 21103, 175.300 (b)(3)(xxxiii) amended ...... 8854 51996 (d) Table 2 corrected; CFR cor- 176.180 (b)(2) table amended...... 60112 rection...... 58775 177 Authority citation revised ...... 48599 (b)(3)(xxxvii) added ...... 63894 177.1060 (e) amended...... 17098 176.170 (a)(5) table amended...... 2293, 177.1395 (b)(4) table amended ...... 32610 14550, 33195, 48391 177.1500 (b) table amended ...... 2977 177.1345 Introductory text re- Technical correction...... 8820 vised; (d) added ...... 62318 (a)(13) revised; (b) table amend- 177.1520 (a)(3)(i)(e) added; (c) ed...... 32610 table amended ...... 10987 177.1520 (c) table ammended ...... 17098 (b) table amended...... 26422, 43730
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21 CFR—Continued 59 FR 21 CFR—Continued 60 FR Page Page Chapter I—Continued Chapter I—Continued 177.1580 (b) table amended ...... 43731 172.841 (a)(1) revised...... 54425 177.1610 (a) amended; (b) added ...... 14550 172.859 (c)(1) and (2) revised ...... 44756 177.2465 Added ...... 5948 173.69 Added ...... 11900 177.2550 (a)(5) added; (d)(1) re- 173.340 (a)(3) table amended...... 54036 vised ...... 9925 174.6 Added ...... 36596 177.2600 (c)(4)(i) amended ...... 46171 175.105 (c)(5) table amended...... 47480, 178.2010 (b) table amended ...... 2735, 49337 8855, 33196, 45973, 62319 175.250 (a), (b)(1) and (2) amend- (b) table corrected ...... 54130 ed ...... 39645 178.3295 Table amended...... 13650, 25323 175.300 (b)(3)(viii)(b) and (xxxiii) 178.3297 (e) table amended....3654, 5705, amended...... 48646 10065, 10066 (b)(3)(xi) amended...... 49337 178.3570 (a)(3) table amended ...... 14551 (b)(3)(xxxiii) amended...... 57339 179.45 (b)(4)(i), (6)(i), (d)(2)(ii), (iii) and (iv) amended...... 14551 176.170 (b)(2) table amended...... 18350 182.1033 Removed...... 63895 (a)(5) table amended ...... 34135, 39646, 182.1195 Removed...... 63895 44757, 62207 182.1625 Removed...... 63895 Regulation at 60 FR 34135 eff. 182.1751 Removed...... 63895 date corrected to 7–31–95...... 47205 182.1911 Removed...... 63895 176.180 (b)(2) table amended...... 18350 182.3616 (c) revised ...... 65939 177.1315 (b) table amended ...... 57926 182.3637 (c) revised ...... 65939 177.1520 (a)(3)(i)(a) redesignated 182.3739 (c) revised ...... 65939 as (a)(3)(i)(a)(1); (a)(3)(i)(a)(2) 182.3766 (c) revised ...... 65939 added; (c) table amended ...... 40074 182.3798 (c) revised ...... 65939 (a)(6) added; (c) table amended 182.3862 (c) revised ...... 65939 ...... 54189 182.6033 Removed...... 63895 177.1630 (a), (b) and (j) introduc- 182.6195 Removed...... 63895 tory text revised; (e)(4)(ii) 182.6386 Removed...... 63895 amended...... 57927 182.6511 Removed...... 63895 (e)(4) amended ...... 61654 182.6625 Removed...... 63895 177.2440 (a) and (b) revised ...... 48648 182.6751 Removed...... 63895 177.2600 (c)(4)(ii)(a) and (b) 182.6851 Removed...... 63895 amended...... 39648 182.8195 Removed...... 63895 177.2910 Introductory text re- 184.1033 Added ...... 63895 vised; (e) and (f) redesignated 184.1139 (c)(2) amended...... 14551 as (f) and (g); (a)(4) and new (e) 184.1140 Added ...... 63896 added...... 54426 184.1195 Added ...... 63896 178.1010 (b)(44) and (c)(38) 184.1386 Added ...... 63896 added...... 18740 184.1538 (b) and (d) amended...... 14364 178.2010 (b) table amended ....8546, 18353, 184.1625 Added ...... 63896 22269, 33711, 43371, 49338, 49507, 54428 184.1751 Added ...... 63896 178.3130 (b) table amended ....18351, 54430 184.1851 Added ...... 63897 178.3297 (e) table amended ....31244, 39649 184.1911 Added ...... 63897 178.3400 (c) table amended ...... 18351 178.3570 (a)(3) table amended ...... 44758 1995 179.26 (b) table amended ...... 12670 21 CFR 60 FR 182.70 Amended...... 62208 Page 184.1012 Added ...... 55789 Chapter I 184.1024 Added ...... 32910 170.3 (e) redesignated as (e)(1); 184.1034 Added ...... 32910 (e)(2) added ...... 36594 184.1101 (a) and (e) revised; eff. 4– 170.39 Added ...... 36595 27–95 ...... 15872 171.8 Added ...... 36596 184.1316 Added ...... 32910 172.120 (b)(1) table amended...... 33710 184.1329 Added ...... 63621 172.723 Added ...... 32903 184.1415 Added ...... 32911 172.800 (c)(12) added...... 21702 184.1443a Added...... 32911
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21 CFR—Continued 60 FR 21 CFR—Continued 61 FR Page Page Chapter I—Continued 176.170 184.1444 (a) amended; (b) re- (a)(5) table amended ...... 10452, vised...... 48893 25394, 37209, 58629 184.1563 (c) revised; eff. 5–13–96...... 57130 (b)(2) table amended ...... 14246, 14480 184.1583 Added ...... 32911 (b)(2) amended...... 14246, 14480 184.1595 Added ...... 32911 176.210 (d)(3) amended ...... 14246 184.1914 Added ...... 32911 177 Nomenclature change ...... 14482 184.1985 Added ...... 54193 Technical correction ...... 27004 186.1555 Added ...... 62208 177.1210 (b)(5) table amended ...... 14480 189.240 Added ...... 33109 177.1345 (b)(1) amended...... 14481 177.1390 (c)(3)(i)(a)(1) amended ...... 14481 1996 177.1480 (b)(2) amended...... 14481 177.1500 (c)(5)(i) amended ...... 14481 21 CFR 61 FR Page (a)(15) added; (b) table amended 172 Nomenclature change ...... 14482 ...... 34371 Technical correction ...... 27004 (a)(16) added; (b) table and 172.133 (a)(2) amended ...... 14245 (c)(5)(ii) amended...... 53853 (b)(3) and (4) added; (c)(2) re- 177.1520 (b) amended...... 14246, 14481 vised ...... 26788 (b) table amended ...... 14246, 172.210 (b)(3) amended ...... 14245 14481, 28050, 37210, 51365 172.320 (b)(2) and (c)(1) amend- (a)(3)(i)(a)(3) added; (c) table ed ...... 14480 amended ...... 59330 172.345 Revised ...... 8807 177.1550 (d)(2)(ii) amended...... 14481 (d) revised...... 27779 177.1556 Added ...... 42381 172.515 (b) amended ...... 14245 177.1630 (e)(4) amended...... 46718 172.804 (c)(23) amended...... 14480 177.1637 Added ...... 14965 Introductory text and (c) re- 177.1655 (a) and (b) table re- vised; (b) amended; (d) re- vised...... 29475 moved; (e) and (f) redesignated 177.2450 (b)(2) and (3) amended ...... 14481 as (d) and (e) ...... 33656 177.2600 (c)(4)(i) amended ...... 14246 172.809 Added ...... 65941 (c)(4)(ii)(b) amended...... 46544 172.841 (b) amended ...... 14480 (c)(4)(ix) amended ...... 60535 172.867 Added ...... 3171 178 Nomenclature change ...... 14482 (d), (e)(1) and (2)(iv) corrected...... 11546 Technical correction ...... 27004 173 Nomenclature change ...... 14482 178.1010 (b)(45) and (c)(39) Technical correction...... 25392, 27004 added...... 28053 173.45 (a) and (c) revised ...... 386 (b)(46) and (c)(40) added...... 31397 173.69 Redesignated as 173.300...... 14245 178.2010 (b) table amended ...... 1831, (a) amended ...... 14480 14246, 46545, 46546, 56892, 65944, 173.300 Redesignated from 66918, 68623 173.69 ...... 14245 178.3295 Table amended...... 33847, 173.310 (c) amended ...... 14245 51588, 65943 173.315 (a)(2) table amended...... 46376, 178.3297 (e) table amended...... 2116, 46377 14246, 48624, 64991 173.325 Added ...... 17829 (c) amended ...... 14481 173.340 (a)(4) table amended...... 632 178.3570 (a)(3) table amended ...1713, 1830 173.357 (a)(2) table amended ...... 4873, 178.3725 Added ...... 43157 14245 178.3780 (b)(1) amended...... 14481 175 Nomenclature change ...... 14482 178.3860 (b) table amended ...... 25396 Technical correction ...... 27004 (b) table corrected ...... 42381 175.105 (c)(5) table amended ...... 2113, 179.21 (b)(2)(ii) and (iii) amend- 6940, 9904, 42379 ed ...... 14246 175.300 (b)(3)(viii)(b) amended ...... 29474 179.41 Added ...... 42383 (b)(3)(vii)(a) amended ...... 37208 179.45 (b) introductory text, (5) 175.320 (b)(3)(i) table amended ...... 14246 and (d) amended...... 14246 176 Nomenclature change ...... 14482 180 Heading revised...... 14246 Technical correction ...... 27004 Nomenclature change...... 14482
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21 CFR—Continued 61 FR 21 CFR—Continued 62 FR Page Page Technical correction ...... 27004 176.200 (d)(3) table amended...... 39772 180.22 (b), (e) and (f)(1) amend- 177 Authority citation revised ...... 51515 ed ...... 14246 177.1345 (d) amended...... 34628 180.25 (a) revised...... 7991 177.1395 (b)(4) table amended ...... 53957 181 Nomenclature change ...... 14482 177.1500 (c) redesignated as (d); Technical correction ...... 27004 new (c) added; new (d)(5)(ii) 182.10 Table amended...... 14246 amended...... 22886 182.1866 Removed...... 43450 177.1520 (b) table corrected; CFR 182.5013—182.5997 (Subpart F) Re- correction ...... 42050, 49908 moved ...... 27779 178 Authority citation revised ...... 51515 182.5484 Redesignated from 178.2010 (b) table amended ...... 2013, 182.8458 ...... 14246 2015, 29009, 30456, 34629, 34630, 182.5697 Heading and (a) amend- 36983, 39441, 41272 ed ...... 14246 178.3130 (b) table amended ...... 31511 182.8458 Redesignated as 178.3297 (e) table amended...... 6723, 182.5484 ...... 14246 9366, 19221, 25477 184.1063 Added ...... 45889 178.3400 (c) table amended ....33997, 42051 184.1193 (c) amended...... 14247 179 Authority citation revised ...... 51515 184.1259 Heading and (a) re- Effective date confirmation ...... 64102 vised...... 36290 179.26 (b) table amended ...... 64121 184.1311 (a), (b) and (c) revised...... 40319 180 Authority citation revised ...... 51515 184.1372 (a) revised ...... 43450 181 Authority citation revised ...... 51515 184.1387 Added ...... 7704 182 Authority citation revised ...... 51515 184.1634 (a) amended...... 14247 184 Authority citation revised ...... 51515 184.1866 Added ...... 43450 184.1 (a) amended ...... 15110 186.1025 Removed...... 27779 184.1472 Revised ...... 30756 189 Nomenclature change ...... 14482 186 Authority citation revised ...... 51515 Technical correction...... 27004, 29650 189 Authority citation revised ...... 51515 189.301 Added ...... 4820 190 Added ...... 49891 197 Removed...... 27779 1998 1997 21 CFR 63 FR 21 CFR 62 FR Page Page 172.155 (c)(1) revised ...... 66015 170 Technical correction...... 47760 172.800 Regulation at 60 FR 21702 Authority citation revised ...... 51515 eff. date confirmed; (c)(13) 170.35 (c)(1)(viii) revised...... 40599 added...... 36362 170.39 (c)(6) and (e) amended ...... 40599 172.824 (b)(3) removed ...... 7069 171 Technical correction...... 47760 172.831 Added ...... 16433 Authority citation revised ...... 51515 172.841 (a)(2) and (b) revised ...... 57597 171.1 (c) amended ...... 40599 172.878 (c) table amended...... 66014 172 Authority citation revised ...... 51515 173.300 (b) revised...... 38747 172.712 Added ...... 26228 173.315 Heading and (c) revised; 172.841 (c) revised...... 30985 (a)(3) redesignated as (a)(4); 173 Authority citation revised ...... 51515 new (a)(3) added; introductory 173.25 (a)(20) revised ...... 7679 text, (a)(2) table and new (4) Regulation at 62 FR 7679 eff. amended ...... 7069 date corrected to 2–20–97 ...... 8312 173.325 (b) revised; (c) and (d) 173.150 (a)(5) added ...... 59284 added...... 11119 174 Authority citation revised ...... 51515 173.340 (a)(4) introductory text re- 175 Authority citation revised ...... 51515 vised; (a)(4) table amended ...... 29134 175.105 (c)(5) table amended ...... 2013, 175.105 (c)(5) table amended...... 37248, 33996, 39937 51527, 56788 175.300 (b)(3)(viii)(b)...... 43076 175.125 (a)(7) added; (b)(1) re- 176 Authority citation revised ...... 51515 vised ...... 3464 176.170 (a)(5) table amended...... 10452, (a)(8) added; (b)(1) revised ...... 51528 39939 175.300 (b)(3)(vii)(a) amended ...... 59707
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21 CFR—Continued 63 FR 21 CFR—Continued 64 FR Page Page (b)(3)(xxviii)(a) ...... 71017 Chapter I—Continued 175.320 (b)(3) table amended...... 71017 175.105 (c)(5) table amended...... 29554, 176.170 (b)(2) table amended...... 69551 45872 176.180 (b)(2) table amended...... 59709, 175.125 (b)(2) amended ...... 48291 63408 175.300 (b)(3)(viii)(a) amended ...... 60106 177.1390 (c)(2)(vii) added; (b)(3)(vii)(a) corrected; CFR cor- (c)(3)(i)(a)(1) revised ...... 55943 rection ...... 4535 177.1430 (b) table amended ...... 36175 175.320 (b)(3) table amended ...... 2568 177.1500 (b) table amended ...... 6854 176.170 (a)(5) table amended...... 27915 177.1520 (a)(1) redesignated as 176.180 (b)(2) table amended...... 46132, (a)(1)(i); (a)(1)(ii) added; (c) 68631 amended ...... 6853 176.300 (c) table amended...... 46130, 69900 177.2415 Added ...... 20315 177.1200 (c) table amended ...... 57978 177.2460 (c)(1) amended ...... 8852 177.1211 Added ...... 28098 177.2600 (c)(4)(i) amended...... 8572 177.1350 (a) introductory text, (1) 178.2010 (b) table amended ...... 8853 through (6) and (b) redesig- (b) table amended.....27836, 29136, 35135, nated as (a)(1) introductory 36177, 36178, 43875, 45716, 55945 text, (i) through (vi) and (b)(1); (b) table corrected; CFR correc- new (a)(2) and (b)(2) added...... 47108 tion...... 49285 177.1390 (c)(1)(i)(e) redesignated 178.3130 (b) table amended ...... 38748 as (c)(1)(i)(f); new (c)(1)(i)(e) 178.3295 Table amended...... 56789, 68392 added ...... 4785 178.3297 (e) table amended...... 3464 (c)(1)(i)(f) revised ...... 46272 (e) table amended.....43874, 55946, 59215, 177.1500 (b) table amended .....46272, 4786 59710 177.1520 (c) table amended ....10944, 27916 178.3400 (c) table amended ...... 29551 (a)(2) redesignated as (a)(2)(i); 178.3725 Table amended...... 35799 (a)(2)(ii) and (3)(vi) added; 179 Technical correction...... 46388 (d)(7) table amended ...... 47108 179.26 (c)(1) amended...... 43876 (a)(3)(ii) revised; (c) table 184.1420 Added ...... 24419 amended ...... 71638 184.1444 (a) amended; (b)(3) 177.1585 (a) and (c)(1) revised...... 27178 added...... 14611 178 Technical correction...... 27854 184.1702 Added ...... 28895 178.2010 (b) table amended ...... 34, 2854, 13507, 24944, 25429, 26282, 30386, 48293, 1999 53926, 65658, 66104, 67485, 72273 21 CFR 64 FR (b) table corrected ...... 46133 Page 178.3130 (b) corrected; CFR cor- Chapter I rection...... 4535 172.345 (b) revised ...... 1758 (b) table amended ...... 62585 172.665 (d)(2) revised ...... 1758 178.3295 Table amended...... 26843 172.723 (b)(3) revised ...... 1759 178.3297 (e) table amended ...26842, 44406, 172.831 Introductory text re- 44407, 72275 moved; (c) revised ...... 43909 178.3400 (c) table amended ...... 45874 172.833 Added ...... 29958 178.3570 (a)(3) table amended ...... 47670, (c) corrected ...... 43072 71639 172.836 (c)(16) added...... 57976 178.3620 (c)(3) corrected; CFR cor- 172.886 (c)(2) revised ...... 44122 rection...... 4535 173.25 (b)(5) and (d)(2) revised...... 14609 178.3725 Table amended...... 48292, 72273 (b)(2)(i) and (ii) added ...... 56173 178.3910 (a)(2) table corrected; 173.310 (c) table amended ...... 1759, 29227 CFR correction ...... 4535 173.315 (a)(2) table amended; (a)(5) (a)(2) table amended ...... 47110 added...... 38564 179.21 (a)(1) revised ...... 69191 173.325 (b)(1) revised...... 26841 184.1007 (b)(1), (6) and (7) re- (d) redesignated as (e); new (d) vised ...... 1759 added ...... 44123 184.1148 Added ...... 19894 (e) redesignated as (f); new (e) 184.1150 Added ...... 19895 added ...... 49982 184.1250 Added ...... 28361
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21 CFR—Continued 64 FR 21 CFR—Continued 65 FR Page Page Chapter I—Continued Chapter I—Continued 184.1257 (b) introductory text and 176.170 (a)(5) table amended...... 13678, (1) revised...... 1759 16520, 20728, 36786 184.1259 (b)(3) revised...... 1760 (b)(2) table amended ...... 8275, 34081 184.1282 (b) revised...... 1760 176.180 (b)(2) table amended...... 36787 184.1293 (b) revised...... 1760 176.300 (c) table amended...... 40497, 70789 184.1428 (a) amended ...... 405 177.1210 (b)(5) table 1 amended ...... 26745 184.1530 (b) revised...... 1760 (b)(5) table amended ...... 52908 184.1699 (b) revised...... 1760 177.1211 (a) and (d) revised; (c) 184.1979 (b)(1) introductory text amended...... 16817 and (2) revised ...... 1760 177.1360 (a)(3) and (d) revised ...... 17135 184.1979a (b)(1) introductory text 177.1520 (a)(3)(vii) added; (c) table and (2) revised ...... 1761 amended ...... 3385 184.1979b (b)(1) introductory text (a)(3)(i)(a)(4) added; (c) table and (2) revised ...... 1761 amended ...... 16313 Corrected ...... 7066 177.2500 Added ...... 15058 184.1979c (b)(1) introductory text 177.2600 (c)(4)(i) amended ...... 68890 and (2) revised ...... 1761 178.2010 (b) table amended ...15546, 16315, 26129, 26746, 38426, 41875 2000 178.3295 Table amended...... 16316 178.3725 Table amended...... 52909 21 CFR 65 FR 179.26 (b) table amended ...... 45281, 64607 Page 179.39 (a) and (b) table revised...... 71057 Chapter I 179 Technical correction...... 76005 170.35 (c)(3) through (6) redesig- nated as (c)(4) through (7); new 2001 (c)(3) added ...... 51762 170.39 (h) amended ...... 56479 (Regulations published from January 1, 171.1 (a) and (c) amended; (n) 2001, through April 1, 2001) added (effective date pend- 21 CFR 66 FR ing) ...... 51763 Page 171.100 (b) redesignated as (c); new 172.133 (c)(2) redesignated as (b) added ...... 51763 (c)(3); (b) and new (c)(3) revised; 172.120 (b)(1) table amended...... 48378 new (c)(2) added ...... 13653 172.135 (b)(1) table amended...... 48379 172.155 (c) revised...... 13847 172.841 (c) revised...... 64605, 79719 175.105 (c)(5) table amended...... 13654 172.846 (c)(9) added ...... 60859 175.125 (a)(9) added; (b)(1) re- 173 Technical correction...... 45522 vised...... 13654 173.300 (a) revised...... 34587 176.170 (b)(2) table amended...... 13655 173.325 (c) revised ...... 1776 176.180 (b)(2) table amended...... 13655 (b) revised...... 16312 178.3297 (e) table amended...... 6469 173.370 Added ...... 70660 178.3400 (c) table amended ...... 13655 175.105 (c)(5) table amended ...8275, 20728 179.45 (b) introductory text and 175.300 (b)(3)(viii)(b) amended ...... 21312 (d) introductory text amend- (b)(3)(xxxiii) amended...... 6892, 37041 ed ...... 10575 175.320 (b)(3) table amended ...6892, 37041 190.6 (a) amended ...... 17359 Æ
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