eDt 6MY9 45 a 1 99Jt136 O000Fm001Ft89 ft89 :SM\804.X fm4PsN:183064F pfrm04 Y:\SGML\183064F.XXX Sfmt8091 Fmt8091 Frm00001 PO00000 Jkt183064 14:52May11, 1999 VerDate 06
For sale by U.S. Government Printing Office Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20402–9328
VerDate 06
?ii Table of Contents
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 ...... 557
Table of CFR Titles and Chapters ...... 571
Alphabetical List of Agencies Appearing in the CFR ...... 589
Redesignation Table ...... 599
List of CFR Sections Affected ...... 601
iii
VerDate 06
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.
iv
VerDate 06
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, 1999), 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.
v
VerDate 06
vi
VerDate 06
RAYMOND A. MOSLEY, Director, Office of the Federal Register. April 1, 1999.
vii
VerDate 06
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, 1999.
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.
For this volume, Ruth Reedy Green was Chief Editor. The Code of Federal Regulations publication program is under the direction of Frances D. McDonald, assisted by Alomha S. Morris.
ix
VerDate 06
VerDate 06
(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.
1
VerDate 06
(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 ...... 138 175 Indirect food additives: Adhesives and components of coatings ...... 139 176 Indirect food additives: Paper and paperboard com- ponents ...... 180 177 Indirect food additives: Polymers ...... 218 178 Indirect food additives: Adjuvants, production aids, and sanitizers ...... 334 179 Irradiation in the production, processing and han- dling of food ...... 418 180 Food additives permitted in food or in contact with food on an interim basis pending additional study ...... 424 181 Prior-sanctioned food ingredients ...... 429 182 Substances generally recognized as safe ...... 433 184 Direct food substances affirmed as generally recog- nized as safe ...... 446
3
VerDate 06
Part Page 186 Indirect food substances affirmed as generally rec- ognized as safe ...... 543 189 Substances prohibited from use in human food ...... 548 190 Dietary supplements ...... 553 191–199 [Reserved]
4
VerDate 06
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
5
VerDate 06
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,
6
VerDate 06
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, puddings, custards, parfaits, pie fill- fruits, citrus, berries, and mixtures; ings, and gelatin base salads. salads, juices and juice punches, con- centrates, dilutions, ‘‘ades’’, and drink (23) Grain products and pastas, in- cluding macaroni and noodle products, substitutes made therefrom. 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.
7
VerDate 06
(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.
8
VerDate 06
(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
9
VerDate 06
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]
10
VerDate 06
§ 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
11
VerDate 06
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.
12
VerDate 06
(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
13
VerDate 06
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
14
VerDate 06
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
15
VerDate 06
each nonclinical study, either a state- conditions different from those pro- ment that the study was conducted in posed to be determined to be GRAS. compliance with the requirements set The failure of any person to come for- forth in part 58 of this chapter, or, if ward with proof of such an applicable the study was not conducted in compli- prior sanction in response to the notice ance with such regulations, a brief of filing will constitute a waiver of the statement of the reason for the non- right to assert or rely on such sanction compliance. at any later time. The notice of filing (vii) [Reserved] will also constitute a proposal to estab- (viii) A claim for categorical exclu- lish a regulation under part 181 of this sion under § 25.30 or § 25.32 of this chap- chapter, incorporating the same provi- ter or an environmental assessment sions, in the event that such a regula- under § 25.40 of this chapter. tion is determined to be appropriate as (2) Within 30 days after the date of a result of submission of proof of such filing the petition, the Commissioner an applicable prior sanction in re- will place the petition on public file in sponse to the notice of filing. the office of the Dockets Management (Information collection requirements were Branch and will publish a notice of fil- approved by the Office of Management and ing in the FEDERAL REGISTER giving Budget under control number 0910–0132) the name of the petitioner and a brief [42 FR 14488, Mar. 15, 1977, as amended at 50 description of the petition including FR 7492, Feb. 22, 1985; 50 FR 16668, Apr. 26, the name of the substance, its proposed 1985; 53 FR 16547, May 10, 1988; 62 FR 40599, use, and any limitations proposed for July 29, 1997] reasons other than safety. A copy of the notice will be mailed to the peti- § 170.38 Determination of food addi- tioner at the time the original is sent tive status. to the FEDERAL REGISTER. (a) The Commissioner may, in ac- (3) 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 (4) The Commissioner will evaluate FEDERAL REGISTER proposing to deter- the petition and all available informa- mine that a substance is not GRAS and tion including all comments received. is a food additive subject to section 409 If the petition and such information of the Act. Any petition shall include provide convincing evidence that the all relevant data and information of substance is GRAS as described in the type described in § 171.130(b). The § 170.30 he will publish an order in the Commissioner will place all of the data FEDERAL REGISTER listing the sub- and information on which he relies on stance as GRAS in part 182, part 184, or public file in the office of the Dockets part 186 of this chapter, as appropriate. Management Branch and will include (5) If, after evaluation of the petition in the FEDERAL REGISTER notice the and all available information, the Com- name of the substance, its known uses, missioner concludes that there is a and a summary of the basis for the de- lack of convincing evidence that the termination. substance is GRAS and that it should (2) The FEDERAL REGISTER notice will be considered a food additive subject to allow a period of 60 days during which section 409 of the Act, he shall publish any interested person may review the a notice thereof in the FEDERAL REG- data and information and/or file com- ISTER in accordance with § 170.38. ments with the Dockets Management (6) The notice of filing in the FED- Branch. Copies of all comments shall ERAL REGISTER will request submission be made available for examination in of proof of any applicable prior sanc- the Dockets Management Branch’s of- tion for use of the ingredient under fice.
16
VerDate 06
(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- [42 FR 14488, Mar. 15, 1977, as amended at 42 dence that the substance is GRAS or is FR 15673, Mar. 22, 1977; 54 FR 24896, June 12, otherwise exempt from the definition 1989] of a food additive in section 201(s) of 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 (a) A substance used in a food-con- will publish an order in the FEDERAL tact article (e.g., food-packaging or REGISTER listing the substance as food-processing equipment) that mi- GRAS in part 182, part 184, or part 186 grates, or that may be expected to mi- of this chapter, as appropriate. grate, into food will be exempted from (c) A FEDERAL REGISTER notice deter- regulation as a food additive because it mining that a substance is a food addi- becomes a component of food at levels tive shall provide for the use of the ad- that are below the threshold of regula- ditive in food or food contact surfaces tion if: as follows: (1) The substance has not been shown (1) It may promulgate a food additive to be a carcinogen in humans or ani- regulation governing use of the addi- mals, and there is no reason, based on tive. the chemical structure of the sub- (2) It may promulgate an interim stance, to suspect that the substance is food additive regulation governing use a carcinogen. The substance must also of the additive. not contain a carcinogenic impurity or, (3) It may require discontinuation of if it does, must not contain a carcino- the use of the additive. genic impurity with a TD50 value based (4) It may adopt any combination of on chronic feeding studies reported in the above three approaches for dif- the scientific literature or otherwise ferent uses or levels of use of the addi- available to the Food and Drug Admin- tive. istration of less than 6.25 milligrams (d) If the Commissioner of Food and per kilogram bodyweight per day (The Drugs is aware of any prior sanction TD50, for the purposes of this section, is for use of the substance, he will con- the feeding dose that causes cancer in currently propose a separate regulation 50 percent of the test animals when covering such use of the ingredient corrected for tumors found in control under part 181 of this chapter. If the animals. If more than one TD50 value Commissioner is unaware of any such has been reported in the scientific lit- applicable prior sanction, the proposed erature for a substance, the Food and regulation will so state and will re- Drug Administration will use the low- quire any person who intends to assert est appropriate TD50 value in its re- or rely on such sanction to submit view.); proof of its existence. Any regulation (2) The substance presents no other promulgated pursuant to this section health or safety concerns because: constitutes a determination that ex- (i) The use in question has been cluded uses would result in adultera- shown to result in or may be expected tion of the food in violation of section to result in dietary concentrations at 402 of the Act, and the failure of any or below 0.5 parts per billion, cor- person to come forward with proof of responding to dietary exposure levels such an applicable prior sanction in re- at or below 1.5 micrograms/person/day sponse to the proposal will constitute a (based on a diet of 1,500 grams of solid waiver of the right to assert or rely on food and 1,500 grams of liquid food per such sanction at any later time. The person per day); or notice will also constitute a proposal (ii) The substance is currently regu- to establish a regulation under part 181 lated for direct addition into food, and of this chapter, incorporating the same the dietary exposure to the substance provisions, in the event that such a resulting from the proposed use is at or regulation is determined to be appro- below 1 percent of the acceptable daily priate as a result of submission of proof intake as determined by safety data in
17
VerDate 06
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): (1) The chemical composition of the (iv) In cases where there is no detect- substance for which the request is able migration into food or food made, including, whenever possible, simulants, or when no residual level of the name of the chemical in accord- a substance is detected in the food-con- ance with current Chemical Abstract tact article by a suitable analytical Service (CAS) nomenclature guidelines method, the Food and Drug Adminis- and a CAS registry number, if avail- tration will, for the purposes of esti- able; mating the dietary concentration, con- (2) Detailed information on the con- sider the validated detection limit of ditions of use of the substance (e.g., the method used to analyze for the sub- temperature, type of food with which stance. the substance will come into contact, (5) The results of an analysis of exist- the duration of the contact, and wheth- ing toxicological information on the er the food-contact article will be for substance and its impurities. This in- repeated or single use applications); formation on the substance is needed (3) A clear statement as to whether to show whether an animal carcinogen the request for exemption from regula- bioassay has been carried out, or tion as a food additive is based on the whether there is some other basis for fact that the use of the substance in suspecting that the substance is a car- the food-contact article results in a di- cinogen or potent toxin. This type of etary concentration at or below 0.5 information on the impurities is need- parts per billion, or on the fact that it ed to show whether any of them are involves the use of a regulated direct carcinogenic, and, if carcinogenic, food additive for which the dietary ex- whether their TD50 values are greater posure is at or below 1 percent of the than 6.25 milligrams per kilogram acceptable dietary intake (ADI); bodyweight per day in accordance with (4) Data that will enable the Food paragraph (a)(1) of this section. and Drug Administration to estimate (6) Information on the environmental the daily dietary concentration result- impact that would result from the pro- ing from the proposed use of the sub- posed use of the substance. The request
18
VerDate 06
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 a food additive or not. Although a sub- (g) If the Food and Drug Administra- stance that migrates to food at a level tion receives significant new informa- that results in a dietary concentration tion that raises questions about the di- at or below the threshold of regulation etary concentration or the safety of a will not be the subject of a regulation substance that the agency has exempt- published in the FEDERAL REGISTER ed from regulation, the Food and Drug and will not appear in the Code of Fed- Administration may reevaluate the eral Regulations, the Food and Drug substance. If the Food and Drug Ad- Administration will maintain a list of ministration tentatively concludes substances exempted from regulation that the information that is available as food additives under this section on about the substance no longer supports display at the Dockets Management an exemption for the use of the food- Branch. This list will include the name contact material from the food addi- of the company that made the request, tive regulations, the agency will notify the chemical name of the substance, any persons that requested an exemp- the specific use for which it has re- tion for the substance of its tentative ceived an exemption from regulation as decision. The requestors will be given a food additive, and any appropriate an opportunity to show why the use of limitations on its use. The list will not the substance should not be regulated include any trade names. This list will under the food additive provisions of enable interested persons to see the the act. If the requestors fail to ade- types of uses of food-contact materials quately respond to the new evidence, being exempted under the regulation. the agency will notify them that fur- Interested persons may also obtain a ther use of the substance in question copy of the list of exempted substances for the particular use will require a by contacting the Food and Drug Ad- food additive regulation. This notifica- ministration’s Office of Premarket Ap- tion will be placed on public display at proval (HFS–200), 200 C St. SW., Wash- the Dockets Management Branch as ington, DC 20204. For actions requiring part of the file of uses of substances ex- an environmental assessment, the empted from regulation as food addi- agency’s finding of no significant im- pact and the evidence supporting that tives. The Food and Drug Administra- finding, contained in the petitioner’s tion recognizes that manufacturers environmental assessment, also will be other than those that actually made a available for public inspection at the request for exemption may also be Dockets Management Branch in ac- using exempted substances in food-con- cordance with § 25.51(b)(2) of this chap- tact articles under conditions of use ter. Requests for copies of releasable (e.g., use levels, temperature, type of information contained in submissions food contacted, etc.) that are similar to requesting exemptions from the food those for which the exemption was additive regulations will be handled in issued. Because only requestors will be accordance with the Food and Drug Ad- notified as part of the revocation proc- ministration’s Freedom of Information ess described in this section, the Food Act procedures, as described in part 20 and Drug Administration plans to no- of this chapter. In particular, data and tify other manufacturers by means of a
19
VerDate 06
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. tially increasing due to changing use (h) Guidelines to assist requestors in patterns in food technology. the preparation of submissions seeking Therefore, the Food and Drug Adminis- exemptions from the food additive reg- tration no longer regards glycine and ulations are available from the Food its salts as generally recognized as safe and Drug Administration’s Office of for use in human food and all out- Premarket Approval (HFS–200), 200 C standing letters expressing sanction for St. SW., Washington, DC 20204. Inter- such use are rescinded. ested persons are encouraged to obtain (b) The Commissioner of Food and specific guidance from the Food and Drugs concludes that by May 8, 1971, Drug Administration on the appro- manufacturers: priate protocols to be used for obtain- (1) Shall reformulate food products ing migration data, on the validation for human use to eliminate added gly- of the analytical methods used to cine and its salts; or quantify migration levels, on the pro- (2) Shall bring such products into cedures used to relate migration data compliance with an authorizing food to dietary exposures, and on any other additive regulation. A food additive pe- issue not specifically covered in the tition supported by toxicity data is re- Food and Drug Administration’s guide- quired to show that any proposed level lines. of glycine or its salts added to foods for human consumption will be safe. [60 FR 36595, July 17, 1995, as amended at 62 FR 40599, July 29, 1997] (c) The status of glycine as generally recognized as safe for use in animal feed, as prescribed in § 582.5049 of this Subpart C—Specific Administra- chapter, remains unchanged because tive Rulings and Decisions the additive is considered an essential nutrient in certain animal feeds and is § 170.45 Fluorine-containing com- safe for such use under conditions of pounds. good feeding practice. The Commissioner of Food and Drugs has concluded that it is in the interest § 170.60 Nitrites and/or nitrates in cur- of the public health to limit the addi- ing premixes. tion of fluorine compounds to foods (a) (a) Nitrites and/or nitrates are food to that resulting from the fluoridation additives when combined in curing pre- of public water supplies as stated in mixes with spices and/or other fla- § 250.203 of this chapter, (b) to that re- voring or seasoning ingredients that sulting from the fluoridation of bottled contain or constitute a source of sec- water within the limitation established ondary or tertiary amines, including in § 103.35(d) of this chapter, and (c) to but not limited to essential oils, diso- that authorized by regulations (40 CFR dium inosinate, disodium guanylate, part 180) under section 408 of the Act. hydrolysates of animal or plant origin (such as hydrolyzed vegetable protein), § 170.50 Glycine (aminoacetic acid) in oleoresins of spices, soy products, and food for human consumption. spice extractives. Such food additives (a) Heretofore, the Food and Drug may be used only after the establish- Administration has expressed the opin- ment of an authorizing food additive ion in trade correspondence that gly- regulation. A food additive petition cine is generally recognized as safe for submitted pursuant to §§ 171.1 and certain technical effects in human food 171.100 of this chapter, supported by when used in accordance with good data demonstrating that nitrosamines manufacturing practice; however: are not formed in curing premixes con- (1) Reports in scientific literature in- taining such food additives, is required dicate that adverse effects were found to establish safety. in cases where high levels of glycine (b) Nitrites and/or nitrates, when were administered in diets of experi- packaged separately from flavoring mental animals. and seasoning in curing premixes, may
20
VerDate 06
continue to be used under prior sanc- (b) Pertinent information may be in- tions in the commercial curing of meat corporated in, and will be considered as and meat products and poultry prod- part of, a petition on the basis of spe- ucts and in accordance with the provi- cific reference to such information sub- sions of §§ 172.170 and 172.175 of this mitted to and retained in the files of chapter that apply to meat curing the Food and Drug Administration. preparations for the home curing of However, any reference to unpublished meat and meat products, including information furnished by a person poultry and wild game. To assure safe other than the applicant will not be use of such ingredients the labeling of considered unless use of such informa- the premixes shall bear instructions to tion is authorized in a written state- the user that such separately packaged ment signed by the person who sub- ingredients are not to be combined mitted it. Any reference to published until just prior to use. Encapsulating information offered in support of a food or coating some or all of the ingredi- additive petition should be accom- ents does not constitute separate pack- panied by reprints or photostatic cop- aging. ies of such references. (c) Petitions shall include the fol- PART 171—FOOD ADDITIVE lowing data and be submitted in the PETITIONS following form: (Date) Subpart A—General Provisions Name of petitioner lllllllllllll Post-office address lllllllllllll Sec. Date lllllllllllllllllllll 171.1 Petitions. Name of food additive and proposed use ll 171.6 Amendment of petition. llllllllllllllllllllllll 171.7 Withdrawal of petition without preju- Petitions Control Branch dice. Food and Drug Administration 171.8 Threshold of regulation for substances Department of Health and Human Services used in food–contact articles. Washington, DC 20204. Subpart B—Administrative Actions on DEAR SIRS: The undersigned, lllll submits this Applications petition pursuant to section 409(b)(1) of the 171.100 Regulation based on petition. Federal Food, Drug, and Cosmetic Act with lllll 171.102 Effective date of regulation. respect to 171.110 Procedure for objections and hear- (Name of the food additive and proposed use) ings. Attached hereto, in triplicate, and consti- 171.130 Procedure for amending and repeal- tuting a part of this petition, are the fol- ing tolerances or exemptions from toler- lowing: ances. A. The name and all pertinent information AUTHORITY: 21 U.S.C. 321, 342, 348, 371. concerning the food additive, including chemical identity and composition of the SOURCE: 42 FR 14489, Mar. 15, 1977, unless food additive, its physical, chemical, and bi- otherwise noted. ological properties, and specifications pre- scribing the minimum content of the desired Subpart A—General Provisions component(s) and identifying and limiting the reaction byproducts and other impuri- § 171.1 Petitions. ties. Where such information is not avail- able, a statement as to the reasons why it is (a) Petitions to be filed with the not should be submitted. Commissioner under the provisions of When the chemical identity and composi- section 409(b) of the Act shall be sub- tion of the food additive is not known, the mitted in triplicate. If any part of the petition shall contain information in suffi- material submitted is in a foreign lan- cient detail to permit evaluation regarding guage, it shall be accompanied by an the method of manufacture and the analyt- accurate and complete English trans- ical controls used during the various stages lation. The petition shall state peti- of manufacturing, processing, or packing of the food additive which are relied upon to es- tioner’s post office address to which tablish that it is a substance of reproducible published notices or orders issued or composition. Alternative methods and con- objections filed pursuant to section 409 trols and variations in methods and controls of the Act may be sent. within reasonable limits that do not affect
21
VerDate 06
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.) F. Proposed tolerances for the food addi- The petition shall include stability data, tive, if tolerances are required in order to in- and, if the data indicate that it is needed to sure its safety. A petitioner may include a insure the identity, strength, quality, or pu- proposed regulation. rity of the additive, the expiration date that G. If submitting petition to modify an ex- will be employed. isting regulation issued pursuant to section B. The amount of the food additive pro- 409(c)(1)(A) of the Act, full information on posed for use and the purposes for which it is each proposed change that is to be made in proposed, together with all directions, rec- the original regulation must be submitted. ommendations, and suggestions regarding The petition may omit statements made in the proposed use, as well as specimens of the the original petition concerning which no labeling proposed for the food additive and change is proposed. A supplemental petition any labeling that will be required by applica- must be submitted for any change beyond ble provisions of the Federal Food, Drug, and the variations provided for in the original Cosmetic Act on the finished food by reason petition and the regulation issued on the of the use of the food additive. If the additive basis of the original petition. results or may reasonably be expected to re- H. The petitioner is required to submit ei- sult from the use of packaging material, the ther a claim for categorical exclusion under petitioner shall show how this may occur § 25.30 or 25.32 of this chapter or an environ- and what residues may reasonably be antici- mental assessment under § 25.40 of this chap- pated. ter. (Typewritten or other draft-labeling copy will be accepted for consideration of the pe- Yours very truly, tition, provided a statement is made that Petitioner llllllllllllllllll final printed labeling identical in content to By llllllllllllllllllllll the draft copy will be submitted as soon as (Indicate authority) available and prior to the marketing of the (d) The petitioner will be notified of food additive.) the date on which his petition is filed; (If the food additive is one for which a tol- and an incomplete petition, or one that erance limitation is required to assure its safety, the level of use proposed should be no has not been submitted in triplicate, higher than the amount reasonably required will usually be retained but not filed as to accomplish the intended physical or other a petition under section 409 of the Act. technical effect, even though the safety data The petitioner will be notified in what may support a higher tolerance.) respects his petition is incomplete. C. Data establishing that the food additive (e) The petition must be signed by will have the intended physical or other the petitioner or by his attorney or technical effect or that it may reasonably be agent, or (if a corporation) by an au- expected to become a component, or to affect thorized official. the characteristics, directly or indirectly, of food and the amount necessary to accom- (f) The data specified under the sev- plish this. These data should include infor- eral lettered headings should be sub- mation in sufficient detail to permit evalua- mitted on separate sheets or sets of tion with control data. sheets, suitably identified. If such data
22
VerDate 06
have already been submitted with an (v) An assay method or other analyt- earlier application, the present peti- ical method, unless it serves no regu- tion may incorporate it by specific ref- latory or compliance purpose and is erence to the earlier. If part of the data shown to fall within the exemption es- have been submitted by the manufac- tablished in § 20.61 of this chapter. turer of the food additive as a master (2) The following data and informa- file, the petitioner may refer to the tion in a food additive petition are not master file if and to the extent he ob- available for public disclosure unless tains the manufacturer’s written per- they have been previously disclosed to mission to do so. The manufacturer the public as defined in § 20.81 of this may authorize specific reference to the chapter or they relate to a product or data without disclosure to the peti- ingredient that has been abandoned tioner. Nothing herein shall prevent and they no longer represent a trade reference to published data. secret or confidential commercial or fi- (g) A petition shall be retained but nancial information as defined in § 20.61 shall not be filed if any of the data pre- of this chapter: scribed by section 409(b) of the Act are (i) Manufacturing methods or proc- lacking or are not set forth so as to be esses, including quality control proce- readily understood. dures. (h)(1) The following data and infor- (ii) Production, sales, distribution, mation in a food additive petition are and similar data and information, ex- available for public disclosure, unless cept that any compilation of such data extraordinary circumstances are and information aggregated and pre- shown, after the notice of filing of the pared in a way that does not reveal petition is published in the FEDERAL data or information which is not avail- REGISTER or, if the petition is not able for public disclosure under this promptly filed because of deficiencies provision is available for public disclo- in it, after the petitioner is informed sure. that it will not be filed because of the (iii) Quantitative or semiquantita- deficiencies involved: tive formulas. (i) All safety and functionality data (3) All correspondence and written and information submitted with or in- summaries of oral discussions relating corporated by reference in the petition. to a food additive petition are avail- (ii) A protocol for a test or study, un- able for public disclosure in accordance less it is shown to fall within the ex- with the provisions of part 20 of this emption established for trade secrets chapter when the food additive regula- and confidential commercial informa- tion is published in the FEDERAL REG- tion in § 20.61 of this chapter. ISTER. (iii) Adverse reaction reports, prod- (4) For purposes of this regulation, uct experience reports, consumer com- safety and functionality data include plaints, and other similar data and in- all studies and tests of a food additive formation, after deletion of: on animals and humans and all studies (a) Names and any information that and tests on a food additive for iden- would identify the person using the tity, stability, purity, potency, per- product. formance, and usefulness. (b) Names and any information that (i)(1) Within 15 days after receipt, the would identify any third party involved Commissioner will notify the peti- with the report, such as a physician or tioner of acceptance or nonacceptance hospital or other institution. of a petition, and if not accepted the (iv) A list of all ingredients contained reasons therefor. If accepted, the date in a food additive, whether or not it is of the notification letter sent to peti- in descending order of predominance. A tioner becomes the date of filing for particular ingredient or group of ingre- the purposes of section 409(b)(5) of the dients shall be deleted from any such Act. If the petitioner desires, he may list prior to public disclosure if it is supplement a deficient petition after shown to fall within the exemption es- being notified regarding deficiencies. If tablished in § 20.61 of this chapter, and the supplementary material or expla- a notation shall be made that any such nation of the petition is deemed ac- ingredient list is incomplete. ceptable, petitioner shall be notified.
23
VerDate 06
The date of such notification becomes sample is requested a reasonable time the date of filing. If the petitioner does in advance of the 180 days, but is not not wish to supplement or explain the submitted within such 180 days after petition and requests in writing that it filing of the petition, the petition will be filed as submitted, the petition shall be considered withdrawn without prej- be filed and the petitioner so notified. udice. The date of such notification becomes (k) If nonclinical laboratory studies the date of filing. are involved, petitions filed with the (2) The Commissioner will publish in Commissioner under section 409(b) of the FEDERAL REGISTER within 30 days the act shall include, with respect to from the date of filing of such petition, each nonclinical study contained in the a notice of the filing, the name of the petition, either a statement that the petitioner, and a brief description of study has been, or will be, conducted in the proposal in general terms. In the compliance with the good laboratory case of a food additive which becomes a practice regulations as set forth in part component of food by migration from 58 of this chapter, or, if any such study packaging material, the notice shall was not conducted in compliance with include the name of the migratory sub- such regulations, a brief statement of stance, and where it is different from the reason for the noncompliance. that of one of the original components, (l) [Reserved] the name of the parent component, the (m) If clinical investigations involv- maximum quantity of the migratory ing human subjects are involved, peti- substance that is proposed for use in tions filed with the Commissioner food, and the physical or other tech- under section 409(b) of the Act shall in- nical effect which the migratory sub- clude statements regarding each such stance or its parent component is in- clinical investigation relied upon in tended to have in the packaging mate- the petition that it either was con- rial. A copy of the notice will be ducted in compliance with the require- mailed to the petitioner when the ments for institutional review set forth original is forwarded to the FEDERAL in part 56 of this chapter, or was not REGISTER for publication. subject to such requirements in accord- (j) The Commissioner may request a ance with § 56.104 or § 56.105, and that it full description of the methods used in, was conducted in compliance with the and the facilities and controls used for, requirements for informed consent set the production of the food additive, or forth in part 50 of this chapter. a sample of the food additive, articles used as components thereof, or of the [42 FR 14489, Mar. 15, 1977, as amended at 42 food in which the additive is proposed FR 15674, Mar. 22, 1977; 46 FR 8952, Jan. 27, to be used, at any time while a petition 1981; 50 FR 7492, Feb. 22, 1985; 50 16668, Apr. 26, is under consideration. The Commis- 1985; 62 FR 40599, July 29, 1997] sioner shall specify in the request for a sample of the food additive, or articles § 171.6 Amendment of petition. used as components thereof, or of the After a petition has been filed, the food in or on which the additive is pro- petitioner may submit additional in- posed to be used, a quantity deemed formation or data in support thereof. adequate to permit tests of analytical In such cases, if the Commissioner de- methods to determine quantities of the termines that the additional informa- food additive present in foods for which tion or data amount to a substantive it is intended to be used or adequate amendment, the petition as amended for any study or investigation reason- will be given a new filing date, and the ably required with respect to the safety time limitation will begin to run anew. of the food additive or the physical or If nonclinical laboratory studies are in- technical effect it produces. The date volved, additional information and used for computing the 90-day limit for data submitted in support of filed peti- the purposes of section 409(c)(2) of the tions shall include, with respect to Act shall be moved forward 1 day for each nonclinical study, either a state- each day after the mailing date of the ment that the study was conducted in request taken by the petitioner to sub- compliance with the requirements set mit the sample. If the information or forth in part 58 of this chapter, or, if
24
VerDate 06
the study was not conducted in compli- is extended as provided for in section ance with such regulations, a brief 409(c)(2) of the Act), a regulation pre- statement of the reason for the non- scribing the conditions under which compliance. the food additive may be safely used (including, but not limited to, speci- [50 FR 7492, Feb. 22, 1985, as amended at 50 16668, Apr. 26, 1985] fications as to the particular food or classes of food in or on which such ad- § 171.7 Withdrawal of petition without ditive may be used, the maximum prejudice. quantity that may be used or per- (a) In some cases the Commissioner mitted to remain in or on such food, will notify the petitioner that the peti- the manner in which such additive may tion, while technically complete, is in- be added to or used in or on such food, adequate to justify the establishment and any directions or other labeling or of a regulation or the regulation re- packaging requirements for such addi- quested by petitioner. This may be due tive deemed necessary by him to assure to the fact that the data are not suffi- the safety of such use), and prior to the ciently clear or complete. In such forwarding of the order to the FEDERAL cases, the petitioner may withdraw the REGISTER for publication shall notify petition pending its clarification or the the petitioner of such order and the obtaining of additional data. This with- reasons for such action; or by order drawal will be without prejudice to a deny the petition, and shall notify the future filing. Upon refiling, the time petitioner of such order and of the rea- limitation will begin to run anew from sons for such action. (b) If the Commissioner determines the date of refiling. that additional time is needed to study (b) At any time before the order pro- and investigate the petition, he shall vided for in § 171.100(a) has been for- by written notice to the petitioner ex- warded to the FEDERAL REGISTER for tend the 90-day period for not more publication, the petitioner may with- than 180 days after the filing of the pe- draw the petition without prejudice to tition. a future filing. Upon refiling the time limitation will begin to run anew. § 171.102 Effective date of regulation. § 171.8 Threshold of regulation for A regulation published in accordance substances used in food-contact ar- with § 171.100(a) shall become effective ticles. upon publication in the FEDERAL REG- Substances used in food-contact arti- ISTER. cles (e.g., food-packaging or food-proc- essing equipment) that migrate or that § 171.110 Procedure for objections and hearings. may be expected to migrate into food at negligible levels may be reviewed Objections and hearings relating to under § 170.39 of this chapter. The Food food additive regulations under section and Drug Administration will exempt 409 (c), (d), or (h) of the Act shall be substances whose uses it determines governed by part 12 of this chapter. meet the criteria in § 170.39 of this [42 FR 14491, Mar. 15, 1977, as amended at 42 chapter from regulation as food addi- FR 15674, Mar. 22, 1977] tives and, therefore, a food additive pe- tition will not be required for the ex- § 171.130 Procedure for amending and empted use. repealing tolerances or exemptions from tolerances. [60 FR 36596, July 17, 1995] (a) The Commissioner, on his own initiative or on the petition of any in- Subpart B—Administrative Actions terested person, pursuant to part 10 of on Applications this chapter, may propose the issuance of a regulation amending or repealing a § 171.100 Regulation based on petition. regulation pertaining to a food additive (a) The Commissioner will forward or granting or repealing an exception for publication in the FEDERAL REG- for such additive. ISTER, within 90 days after filing of the (b) Any such petition shall include an petition (or within 180 days if the time assertion of facts, supported by data,
25
VerDate 06
showing that new information exists 172.275 Synthetic paraffin and succinic de- with respect to the food additive or rivatives. that new uses have been developed or 172.280 Terpene resin. old uses abandoned, that new data are available as to toxicity of the chem- Subpart D—Special Dietary and Nutritional ical, or that experience with the exist- Additives ing regulation or exemption may jus- 172.310 Aluminum nicotinate. tify its amendment or repeal. New data 172.315 Nicotinamide-ascorbic acid complex. shall be furnished in the form specified 172.320 Amino acids. in §§ 171.1 and 171.100 for submitting pe- 172.325 Bakers yeast protein. titions. 172.330 Calcium pantothenate, calcium chlo- ride double salt. [42 FR 14491, Mar. 15, 1977, as amended at 42 172.335 D-Pantothenamide. FR 15674, Mar. 22, 1977] 172.340 Fish protein isolate. 172.345 Folic acid (folacin). PART 172—FOOD ADDITIVES PER- 172.350 Fumaric acid and salts of fumaric MITTED FOR DIRECT ADDITION TO acid. FOOD FOR HUMAN CONSUMP- 172.365 Kelp. TION 172.370 Iron-choline citrate complex. 172.372 N–Acetyl–L–methionine. Subpart A—General Provisions 172.375 Potassium iodide. 172.385 Whole fish protein concentrate. Sec. 172.395 Xylitol. 172.5 General provisions for direct food ad- 172.399 Zinc methionine sulfate. ditives. Subpart E—Anticaking Agents Subpart B—Food Preservatives 172.410 Calcium silicate. 172.105 Anoxomer. 172.430 Iron ammonium citrate. 172.110 BHA. 172.480 Silicon dioxide. 172.115 BHT. 172.490 Yellow prussiate of soda. 172.120 Calcium disodium EDTA. 172.130 Dehydroacetic acid. 172.133 Dimethyl dicarbonate. Subpart F—Flavoring Agents and Related 172.135 Disodium EDTA. Substances 172.140 Ethoxyquin. 172.510 Natural flavoring substances and 172.145 Heptylparaben. natural substances used in conjunction 172.150 4-Hydroxymethyl-2,6-di-tert-butyl- with flavors. phenol. 172.155 Natamycin (pimaricin). 172.515 Synthetic flavoring substances and 172.160 Potassium nitrate. adjuvants. 172.165 Quaternary ammonium chloride 172.520 Cocoa with dioctyl sodium sulfo- combination. succinate for manufacturing. 172.170 Sodium nitrate. 172.530 Disodium guanylate. 172.175 Sodium nitrite. 172.535 Disodium inosinate. 172.177 Sodium nitrite used in processing 172.540 DL–Alanine. smoked chub. 172.560 Modified hop extract. 172.180 Stannous chloride. 172.575 Quinine. 172.185 TBHQ. 172.580 Safrole-free extract of sassafras. 172.190 THBP. 172.585 Sugar beet extract flavor base. 172.590 Yeast-malt sprout extract. Subpart C—Coatings, Films and Related Substances Subpart G—Gums, Chewing Gum Bases 172.210 Coatings on fresh citrus fruit. and Related Substances 172.215 Coumarone-indene resin. 172.610 Arabinogalactan. 172.225 Methyl and ethyl esters of fatty 172.615 Chewing gum base. acids produced from edible fats and oils. 172.230 Microcapsules for flavoring sub- 172.620 Carrageenan. stances. 172.623 Carrageenan with polysorbate 80. 172.235 Morpholine. 172.626 Salts of carrageenan. 172.250 Petroleum naphtha. 172.655 Furcelleran. 172.255 Polyacrylamide. 172.660 Salts of furcelleran. 172.260 Oxidized polyethylene. 172.665 Gellan gum. 172.270 Sulfated butyl oleate. 172.695 Xanthan gum.
26
VerDate 06
Subpart H—Other Specific Usage Additives 172.864 Synthetic fatty alcohols. 172.866 Synthetic glycerin produced by the 172.710 Adjuvants for pesticide use dilu- hydrogenolysis of carbohydrates. tions. 172.867 Olestra. 172.712 1,3–Butylene glycol. 172.868 Ethyl cellulose. 172.715 Calcium lignosulfonate. 172.870 Hydroxypropyl cellulose. 172.720 Calcium lactobionate. 172.872 Methyl ethyl cellulose. 172.723 Epoxidized soybean oil. 172.874 Hydroxypropyl methylcellulose. 172.725 Gibberellic acid and its potassium 172.876 Castor oil. salt. 172.878 White mineral oil. 172.730 Potassium bromate. 172.880 Petrolatum. 172.735 Glycerol ester of wood rosin. 172.882 Synthetic isoparaffinic petroleum 172.755 Stearyl monoglyceridyl citrate. hydrocarbons. 172.765 Succistearin (stearoyl propylene gly- 172.884 Odorless light petroleum hydro- col hydrogen succinate). carbons. 172.770 Ethylene oxide polymer. 172.886 Petroleum wax. 172.775 Methacrylic acid-divinylbenzene co- 172.888 Synthetic petroleum wax. polymer. 172.890 Rice bran wax. 172.892 Food starch-modified. Subpart I—Multipurpose Additives 172.894 Modified cottonseed products in- tended for human consumption. 172.800 Acesulfame potassium. 172.896 Dried yeasts. 172.802 Acetone peroxides. 172.898 Bakers yeast glycan. 172.804 Aspartame. 172.806 Azodicarbonamide. AUTHORITY: 21 U.S.C. 321, 341, 342, 348, 371, 172.808 Copolymer condensates of ethylene 379e. oxide and propylene oxide. SOURCE: 42 FR 14491, Mar. 15, 1977, unless 172.809 Curdlan. otherwise noted. 172.810 Dioctyl sodium sulfosuccinate. 172.811 Glyceryl tristearate. EDITORIAL NOTE: Nomenclature changes to 172.812 Glycine. part 172 appear at 61 FR 14482, Apr. 2, 1996. 172.814 Hydroxylated lecithin. 172.816 Methyl glucoside-coconut oil ester. Subpart A—General Provisions 172.818 Oxystearin. 172.820 Polyethylene gylcol (mean molec- § 172.5 General provisions for direct ular weight 200–9,500). food additives. 172.822 Sodium lauryl sulfate. 172.824 Sodium mono- and dimethyl naph- (a) Regulations prescribing condi- thalene sulfonates. tions under which food additive sub- 172.826 Sodium stearyl fumarate. stances may be safely used predicate 172.828 Acetylated monoglycerides. usage under conditions of good manu- 172.830 Succinylated monoglycerides. facturing practice. For the purposes of 172.831 Sucralose. this part, good manufacturing practice 172.832 Monoglyceride citrate. 172.834 Ethoxylated mono- and diglycerides. shall be defined to include the fol- 172.836 Polysorbate 60. lowing restrictions. 172.838 Polysorbate 65. (1) The quantity of the substance 172.840 Polysorbate 80. added to food does not exceed the 172.841 Polydextrose. amount reasonably required to accom- 172.842 Sorbitan monostearate. plish its intended physical, nutritive, 172.844 Calcium stearoyl-2-lactylate. or other technical effect in food. 172.846 Sodium stearoyl lactylate. (2) Any substance intended for use in 172.848 Lactylic esters of fatty acids. or on food is of appropriate food grade 172.850 Lactylated fatty acid esters of glyc- erol and propylene glycol. and is prepared and handled as a food 172.852 Glyceryl-lacto esters of fatty acids. ingredient. 172.854 Polyglycerol esters of fatty acids. (b) The existence of a regulation pre- 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- nut oil, palm kernel oil, or both oils. (c) The existence of any regulation 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
27
VerDate 06
or required as a supplement to the diet Register, 800 North Capitol Street, of humans. NW., suite 700, Washington, DC 20408. (4) Heavy metals as lead (as Pb), not Subpart B—Food Preservatives more than 10 parts per million. Arsenic (as As), not more than 3 parts per mil- § 172.105 Anoxomer. lion. Mercury (as Hg), not more than 1 Anoxomer as identified in this sec- part per million. tion may be safely used in accordance (c) Anoxomer may be safely used as with the following conditions: an antioxidant in food at a level of not (a) Anoxomer is 1,4-benzenediol, 2- more than 5,000 parts per million based (1,1-dimethylethyl)-polymer with on fat and oil content of the food. diethenylbenzene, 4-(1,1-dimethyl- [48 FR 18798, Apr. 26, 1983, as amended at 54 ethyl)phenol, 4- methoxyphenol, 4,4′-(1- FR 24896, June 12, 1989] methylethylidene)bis(phenol) and 4- methylphenol (CAS Reg. No. 60837–57–2) § 172.110 BHA. prepared by condensation polymeriza- The food additive BHA (butylated hy- tion of divinylbenzene (m- and p-) with droxyanisole) alone or in combination tert-butylhydroquinone, tert-butyl- with other antioxidants permitted in phenol, hydroxyanisole, p-cresol and food for human consumption in this 4,4′-isopropylidenediphenol. subpart B may be safely used in or on (b) The polymeric antioxidant meets specified foods, as follows: the following specifications: (a) The BHA meets the following (1) Polymer, not less than 98.0 per- specification: cent as determined by an ultraviolet method entitled ‘‘Ultraviolet Assay, Assay (total BHA), 98.5 percent minimum. ° ‘‘1982, which is incorporated by ref- Melting point 48 C minimum. erence. Copies are available from the (b) The BHA is used alone or in com- Center for Food Safety and Applied Nu- bination with BHT, as an antioxidant trition (HFS–200), Food and Drug Ad- in foods, as follows: ministration, 200 C St. SW., Wash- Limitations ington, DC 20204, or available for in- (total BHA spection at the Office of the Federal Food and BHT) parts per Register, 800 North Capitol Street, million NW., suite 700, Washington, DC 20408. (2) Molecular weight: Total mono- Dehydrated potato shreds ...... 50 Active dry yeast ...... 1 1,000 mers, dimers and trimers below 500 not Beverages and desserts prepared from dry more than 1 percent as determined by a mixes ...... 1 2 method entitled ‘‘Low Molecular Dry breakfast cereals ...... 50 Dry diced glazed fruit ...... 1 32 Weight Anoxomer Analysis,’’ 1982, Dry mixes for beverages and desserts ...... 1 90 which is incorporated by reference. Emulsion stabilizers for shortenings ...... 200 Copies are available from the Center Potato flakes ...... 50 Potato granules ...... 10 for Food Safety and Applied Nutrition Sweet potato flakes ...... 50 (HFS–200), Food and Drug Administra- tion, 200 C St. SW., Washington, DC 1 BHA only. 20204, or available for inspection at the (c) To assure safe use of the additive: Office of the Federal Register, 800 (1) The label of any market package North Capitol Street, NW., suite 700, of the additive shall bear, in addition Washington, DC 20408. to the other information required by (3) Phenol content: Not less than 3.2 the Act, the name of the additive. milliequivalent/gram and not more (2) When the additive is marketed in than 3.8 milliequivalent/gram as deter- a suitable carrier, in addition to meet- mined by a method entitled ‘‘Total ing the requirement of paragraph (c)(1) Phenols,’’ 1982, which is incorporated of this section, the label shall declare by reference. Copies are available from the percentage of the additive in the the Center for Food Safety and Applied mixture. Nutrition (HFS–200), Food and Drug (3) The label or labeling of dry mixes Administration, 200 C St. SW., Wash- for beverages and desserts shall bear ington, DC 20204, or available for in- adequate directions for use to provide spection at the Office of the Federal that beverages and desserts prepared
28
VerDate 06
from the dry mixes contain no more Limita- tion than 2 parts per million BHA. Food (parts Use per mil- § 172.115 BHT. lion) The food additive BHT (butylated hy- Cabbage, pickled ...... 220 Promote color, flavor, and texture retention. droxytoluene), alone or in combination Canned carbonated soft 33 Promote flavor reten- with other antioxidants permitted in drinks. tion. this subpart B may be safely used in or Canned white potatoes 110 Promote color retention. Clams (cooked canned) 340 Promote color retention. on specified foods, as follows: Crabmeat (cooked 275 Retard struvite forma- (a) The BHT meets the following canned). tion; promote color specification: Assay (total BHT) 99 per- retention. Cucumbers pickled ...... 220 Promote color, flavor, cent minimum. and texture retention. (b) The BHT is used alone or in com- Distilled alcoholic bev- 25 Promote stability of bination with BHA, as an antioxidant erages. color, flavor, and/or product clarity. in foods, as follows: Dressings, nonstandard- 75 Preservative. ized. Limitations Dried lima beans 310 Promote color retention. (total BHA (cooked canned). Food and BHT) Egg product that is 1 200 Preservative. parts per hard-cooked and con- million sists, in a cylindrical shape, of egg white Dehydrated potato shreds ...... 50 with an inner core of Dry breakfast cereals ...... 50 egg yolk. Emulsion stabilizers for shortenings ...... 200 Fava beans (cooked 365 Promote color retention. Potato flakes ...... 50 canned). Potato granules ...... 10 Fermented malt bev- 25 Antigushing agent. Sweetpotato flakes ...... 50 erages. French dressing ...... 75 Preservative. Mayonnaise ...... 75 Do. (c) To assure safe use of the additive: Mushrooms (cooked 200 Promote color retention. (1) The label of any market package canned). of the additive shall bear, in addition Oleomargarine ...... 75 Preservative. Pecan pie filling ...... 100 Promote color retention. to the other information required by Pink beans (cooked 165 Promote color retention. the Act, the name of the additive. canned). Potato salad ...... 100 Preservative. (2) When the additive is marketed in Processed dry pinto 800 Promote color retention. a suitable carrier, in addition to meet- beans. ing the requirement of paragraph (c)(1) Red beans (cooked 165 Promote color retention. canned). of this section, the label shall declare Salad dressing ...... 75 Preservative. the percentage of the additive in the Sandwich spread ...... 100 Do. mixture. Sauces ...... 75 Do. Shrimp (cooked 250 Retard struvite forma- canned). tion; promote color § 172.120 Calcium disodium EDTA. retention. Spice extractives in 60 Promote color and fla- The food additive calcium disodium soluble carriers. vor retention. EDTA (calcium disodium ethylene- Spreads, artificially col- 100 Promote color retention. diaminetetraacetate) may be safely ored and lemon-fla- vored or orange-fla- used in designated foods for the pur- vored. poses and in accordance with the condi- 1 By weight of egg yolk portion. tions prescribed, as follows: (a) The additive contains a minimum (2) With disodium EDTA (disodium of 99 percent by weight of either the di- ethylenediaminetetraacetate) in the hydrate C H O N CaNa ·2H O or the following foods at not to exceed, in 10 12 8 2 2 2 combination, the levels prescribed, cal- trihydrate C10H12O8N2CaNa2·3H2O, or any mixture of the two. culated as anhydrous C10H12O8N2CaNa2: (b) It is used or intended for use as Limita- follows: tion Food (parts Use (1) Alone, in the following foods at per mil- not to exceed the levels prescribed, cal- lion) culated as the anhydrous compound: Dressings, nonstandardized .... 75 Preservative.
29
VerDate 06
Limita- (a) The additive meets the following tion specifications: Food (parts Use per mil- (1) The additive has a purity of not lion) less than 99.8 percent as determined by French dressing ...... 75 Do. the following titration method: Mayonnaise ...... 75 Do. Salad dressing ...... 75 Do. PRINCIPLES OF METHOD Sandwich spread ...... 100 Do. Dimethyl dicarbonate (DMDC) is mixed Sauces ...... 75 Do. with excess diisobutylamine with which it reacts quantitatively. The excess amine is (c) To assure safe use of the additive: backtitrated with acid. (1) The label and labeling of the addi- tive container shall bear, in addition to APPARATUS the other information required by the 250-milliliter (mL) Beaker Act, the name of the additive. 100-mL Graduate cylinder (2) The label or labeling of the addi- 25-mL Pipette 10-mL Burette (automatic, eg., Metrohm bu- tive container shall bear adequate use rette) directions to provide a final food prod- Stirrer uct that complies with the limitations Device for potentiometric titration provided in paragraph (b) of this sec- Reference electrode tion. Glass electrode
(d) In the standardized foods listed in REAGENTS paragraph (b) of this section, the addi- tives are used only in compliance with Acetone, analytical-grade Solution of 1 N diisobutylamine in chloro- the applicable standards of identity for benzene, distilled such foods. 1 N Acetic Acid
[42 FR 14491, Mar. 15, 1977, as amended at 48 PROCEDURE FR 10815, Mar. 15, 1983; 58 FR 52222, Oct. 7, 1993; 60 FR 33710, June 29, 1995] Accurately weigh in about 2 grams of the sample (W) and dissolve in 100 mL acetone. § 172.130 Dehydroacetic acid. Add accurately 25 mL of the 1 N diisobutyl- amine solution by pipette and allow to stand The food additive dehydroacetic acid for 5 minutes. Subsequently, titrate the re- and/or its sodium salt may be safely action mixture potentiometrically with 1 N used in accordance with the following hydrochloric acid (consumption=a mL) while prescribed conditions: stirring. For determining the blank con- (a) The food additive meets the fol- sumption, carry out the analysis without a lowing specifications: sample (consumption=b mL). Dehydroacetic acid: Melting point, 109 °C–111 CALCULATION °C; assay, minimum 98 percent (dry basis). Sodium salt of dehydroacetic acid: Assay, ()b− a ×13. 4 minimum 98 percent (dry basis). = % DMDC (b) It is used or intended for use as a W preservative for cut or peeled squash, NOTE: For adding the diisobutylamine so- lution, always use the same pipette and wait and is so used that no more than 65 for a further three drops to fall when the parts per million expressed as dehydro- flow has stopped. acetic acid remains in or on the pre- (2) The additive contains not more pared squash. than 2,000 ppm (0.2 percent) dimethyl (c) The label or labeling of any pack- carbonate as determined by a method age of the additive intended for use in entitled ‘‘Gas Chromatography Method food shall bear adequate directions for for Dimethyl Carbonate Impurity in use to insure compliance with this sec- Dimethyl Dicarbonate,’’ whichis incor- tion. porated by reference in accordance with 5 U.S.C. 552(a). Copies are avail- § 172.133 Dimethyl dicarbonate. able from the Center for Food Safety Dimethyl dicarbonate (CAS Reg. No. and Applied Nutrition (HFS–200), 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
30
VerDate 06
Street, NW., suite 700, Washington, DC scribed in parts (b)(3) and (b)(4) of this 20408. section. (b) The additive is used or intended [53 FR 41329, Oct. 21, 1988, as amended at 58 for use as follows: FR 6091, Jan. 26, 1993; 59 FR 5319, Feb. 4, 1994; (1) Inhibitor of yeast in wine, dealco- 61 FR 14245, Apr. 1, 1996; 61 FR 26788, May 29, holized wine, and low alcohol wine, 1996] under normal circumstances of bot- tling where the viable yeast count has § 172.135 Disodium EDTA. been reduced to 500 per milliliter or The food additive disodium EDTA less by current good manufacturing (disodium ethylenediaminetetraace- practices such as flash pasteurization tate) may be safely used in designated or filtration. The additive may be foods for the purposes and in accord- added to wine, dealcoholized wine, or ance with the following prescribed con- low alcohol wine in an amount not to ditions: (a) The additive contains a minimum exceed 200 parts per million (ppm). of 99 percent disodium ethylenedia- (2) Inhibitor of yeast in ready-to- minetetraacetate dihydrate drink teas, under normal cir- (C10H14O8N2Na2·2H2O). cumstances of bottling or canning (b) It is used or intended for use as where the viable yeast count has been follows: reduced to 500 per milliliter or less by (1) Alone, in the following foods at current good manufacturing practices not to exceed the levels prescribed, cal- such as heat treatment, sterile filtra- culated as anhydrous calcium disodium tion, or both. The additive may be EDTA: added to teas in an amount not to ex- Limita- ceed 250 ppm. tion (3) Inhibitor of yeast in carbonated or Food (parts Use per mil- noncarbonated, nonjuice-containing lion) (less than or equal to 1 percent juice), Aqueous multivitamin prep- 150 With iron salts as a flavored or unflavored beverages con- arations. stabilizer for vita- taining added electrolytes (5–20 milli- min B 12 in liquid equivalents (meq)/liter sodium ion multivitamin prep- arations. (Na+) and 3–7 meq/liter potassium ion Canned black-eyed peas .... 145 Promote color re- (K+)). The additive may be added to the tention. beverage in an amount not to exceed Canned cooked chickpeas .. 165 Do. Canned kidney beans ...... 165 Preservative. 250 ppm. Canned strawberry pie filling 500 Promote color re- (4) Inhibitor of yeast in carbonated, tention. dilute beverages containing juice, fruit Cooked sausage ...... 36 As a cure accel- erator with so- flavor, or both, with juice content not dium ascorbate to exceed 50 percent. The additive may or ascorbic acid. be added to the beverage in an amount Dressings, nonstandardized 75 Preservative. French dressing ...... 75 Do. not to exceed 250 ppm. Frozen white potatoes in- 100 Promote color re- (c) To ensure the safe use of the food cluding cut potatoes. tention. additive, the label of the package con- Gefilte fish balls or patties in 1 50 Inhibit discoloration. packing medium. taining the additive shall bear, in addi- Mayonnaise ...... 75 Preservative. tion to other information required by Ready-to-eat cereal prod- 2 315 Promote color re- the Federal Food, Drug, and Cosmetic ucts containing dried ba- tention. nanas. Act: Salad dressing ...... 75 Preservative. (1) The name of the additive ‘‘di- Sandwich spread ...... 100 Do. methyl dicarbonate.’’ Sauces ...... 75 Do. 1 Based on total weight of finished product including packing (2) Directions to provide that not medium. more than 200 ppm of dimethyl dicar- 2 In dried banana component of cereal product. bonate will be added to the wine, de- (2) With calcium disodium EDTA alcoholized wine, or low alcohol wine (calcium disodium ethylenediamine- and not more than 250 ppm of dimethyl tetraacetate; calcium disodium dicarbonate will be added to the ready- (ethylenedinitrilo) tetraacetate), in the to-drink tea or to the beverages de- following foods at not to exceed, in
31
VerDate 06
combination, the levels prescribed, cal- Zero in milk. culated as anhydrous C10H12O8N2CaNa2: § 172.145 Heptylparaben. Limita- tion (a) The food additive heptylparaben Food (parts Use is the chemical n-heptyl p-hydroxy- per mil- lion) benzoate. (b) It may be safely used to inhibit Dressings, nonstandardized 75 Preservative. microbiological spoilage in accordance French dressing ...... 75 Do. Mayonnaise ...... 75 Do. with the following prescribed condi- Salad dressing ...... 75 Do. tions: Sandwich spread ...... 100 Do. (1) In fermented malt beverages in Sauces ...... 75 Do. amounts not to exceed 12 parts per mil- lion. (3) Alone, as a sequestrant in the (2) In noncarbonated soft drinks and nonnutritive sweeteners that are listed fruit-based beverages in amounts not in § 180.37 of this chapter and that, in to exceed 20 parts per million, when addition, are designed for aqueous solu- standards of identity established under tion: That the amount of the Provided, section 401 of the Act (21 U.S.C. 341) do additive, calculated as anhydrous cal- not preclude such use. cium disodium EDTA, does not exceed 0.1 percent by weight of the dry non- § 172.150 4-Hydroxymethyl-2,6-di-tert- nutritive sweetener. butylphenol. (c) To assure the safe use of the addi- The food additive 4-hydroxymethyl- tive: 2,6-di-tert-butylphenol may be safely (1) The label and labeling of the addi- used in food in accordance with the fol- tive container shall bear, in addition to lowing prescribed conditions: the other information required by the (a) The additive has a solidification act, the name of the additive. point of 140 °C–141 °C. (2) The label or labeling of the addi- (b) The additive is used as an anti- tive container shall bear adequate use oxidant alone or in combination with directions to provide a final food prod- other permitted antioxidants. uct that complies with the limitations (c) The total amount of all anti- provided in paragraph (b) of this sec- oxidants added to such food shall not tion. exceed 0.02 percent of the oil or fat con- (d) In the standardized foods listed in tent of the food, including the essential paragraphs (b) (1) and (2) of this section (volatile) oil content of the food. the additives are used only in compli- ance with the applicable standards of § 172.155 Natamycin (pimaricin). identity for such foods. (a) Natamycin (CAS Reg. No. 7681–93– § 172.140 Ethoxyquin. 8), also known as pimaricin, is a pol- yene macrolide antimycotic substance (a) Ethoxyquin (1,2-dihydro-6-ethoxy- possessing an empirical formula of 2,2,4-trimethylquinoline) may be safely C33H47NO13 and a molecular weight of used as an antioxidant for preservation 665.7. of color in the production of chili pow- (b) The additive shall conform to the der, paprika, and ground chili at levels following specifications: not in excess of 100 parts per million. (b) In order to provide for the safe Purity: 97 percent ±2 percent on an anhy- use of the additive in feed prepared in drous basis. accordance with §§ 573.380 and 573.400 of Arsenic: Not more than 1 part per million. Heavy metals (as Pb): Not more than 20 parts this chapter, tolerances are established per million. for residues of ethoxyquin in or on edi- ble products of animals as follows: (c) The additive may be applied to the surface of cuts and slices of cheese 5 parts per million in or on the uncooked fat to inhibit mold spoilage with the fol- of meat from animals except poultry. lowing limitations: 3 parts per million in or on the uncooked liver and fat of poultry. (1) The additive may be applied as a 0.5 part per million in or on the uncooked dry mix containing the additive and muscle meat of animals. safe and suitable anticaking agents, re- 0.5 part per million in poultry eggs. sulting in no more than 20 parts per
32
VerDate 06
million of the additive in the finished Component Parts per product, or by dipping or spraying, million using an aqueous solution containing n-Dodecyl dimethyl benzyl ammonium chloride 0.25±1.0 200 to 300 parts per million of the addi- n-Dodecyl dimethyl ethylbenzyl ammonium chloride ...... 3.4±13.5 tive. n-Hexadecyl dimethyl benzyl ammonium chlo- (2) The additive may be applied to ride ...... 1.5±6.0 the surface of those cuts and slices of n-Octadecyl dimethyl benzyl ammonium chlo- ride ...... 0.25±1.0 cheese(s) listed in part 133 of this chap- n-Tetradecyl dimethyl benzyl ammonium chlo- ter only if the cheese standards provide ride ...... 3.0±12.0 for the use of ‘‘safe and suitable’’ mold- n-Tetradecyl dimethyl ethylbenzyl ammonium chloride ...... 1.6±6.5 inhibiting ingredients. [47 FR 26823, June 22, 1982, as amended at 50 [50 FR 3890, Jan. 29, 1985] FR 49536, Dec. 3, 1985; 63 FR 66015, Dec. 1, 1998] § 172.170 Sodium nitrate. The food additive sodium nitrate § 172.160 Potassium nitrate. may be safely used in or on specified The food additive potassium nitrate foods in accordance with the following may be safely used as a curing agent in prescribed conditions: the processing of cod roe, in an amount (a) It is used or intended for use as not to exceed 200 parts per million of follows: the finished roe. (1) As a preservative and color fixa- tive, with or without sodium nitrite, in § 172.165 Quaternary ammonium chlo- smoked, cured sablefish, smoked, cured ride combination. salmon, and smoked, cured shad, so that the level of sodium nitrate does The food additive, quaternary ammo- not exceed 500 parts per million and the nium chloride combination, may be level of sodium nitrite does not exceed safely used in food in accordance with 200 parts per million in the finished the following conditions: product. (a) The additive contains the fol- (2) As a preservative and color fixa- lowing compounds: n-dodecyl dimethyl tive, with or without sodium nitrite, in benzyl ammonium chloride (CAS Reg. meat-curing preparations for the home No. 139–07–1); n-dodecyl dimethyl ethyl- curing of meat and meat products (in- benzyl ammonium chloride (CAS Reg. cluding poultry and wild game), with No. 27479–28–3); n-hexadecyl dimethyl directions for use which limit the benzyl ammonium chloride (CAS Reg. amount of sodium nitrate to not more No. 122–18–9); n-octadecyl dimethyl than 500 parts per million in the fin- benzyl ammonium chloride (CAS Reg. ished meat product and the amount of No. 122–19–0); n-tetradecyl dimethyl sodium nitrite to not more than 200 benzyl ammonium chloride (CAS Reg. parts per million in the finished meat No. 139–08–2); n-tetradecyl dimethyl product. ethylbenzyl ammonium chloride (CAS (b) To assure safe use of the additive, Reg. No. 27479–29–4). in addition to the other information re- (b) The additive meets the following quired by the Act: (1) The label of the additive or of a specifications: pH (5 percent active so- mixture containing the additive shall lution) 7.0–8.0; total amines, maximum bear: 1 percent as combined free amines and (i) The name of the additive. amine hydrochlorides. (ii) A statement of the concentration (c) The additive is used as an anti- of the additive in any mixture. microbial agent, as defined in (2) If in a retail package intended for § 170.3(o)(2) of this chapter, in raw sugar household use, the label and labeling of cane juice. It is added prior to clari- the additive, or of a mixture con- fication when further processing of the taining the additive, shall bear ade- sugar cane juice must be delayed. quate directions for use to provide a (d) The additive is applied to the final food product that complies with sugar juice in the following quantities, the limitations prescribed in paragraph based on the weight of the raw cane: (a) of this section.
33
VerDate 06
(3) If in a retail package intended for ditive, shall bear the statement ‘‘Keep household use, the label of the additive out of the reach of children’’. or of a mixture containing the addi- tive, shall bear the statement ‘‘Keep § 172.177 Sodium nitrite used in proc- out of the reach of children’’. essing smoked chub. The food additive sodium nitrite may § 172.175 Sodium nitrite. be safely used in combination with salt The food additive sodium nitrite may (NaCl) to aid in inhibiting the out- be safely used in or on specified foods growth and toxin formation from Clos- in accordance with the following pre- tridium botulinum type E in the com- scribed conditions: mercial processing of smoked chub in (a) It is used or intended for use as accordance with the following pre- follows: scribed conditions: (1) As a color fixative in smoked (a) All fish in smoking establish- cured tunafish products so that the ments shall be clean and wholesome level of sodium nitrite does not exceed and shall be expeditiously processed, 10 parts per million (0.001 percent) in packed, and stored under adequate san- the finished product. itary conditions in accordance with (2) As a preservative and color fixa- good manufacturing practice. tive, with or without sodium nitrate, (b) The brining procedure is con- in smoked, cured sablefish, smoked, trolled in such a manner that the cured salmon, and smoked, cured shad water phase portion of the edible por- so that the level of sodium nitrite does tion of the finished smoked product has not exceed 200 parts per million and the a salt (NaCl) content of not less than level of sodium nitrate does not exceed 3.5 percent, as measured in the loin 500 parts per million in the finished muscle, and the sodium nitrite content product. of the edible portion of the finished (3) As a preservative and color fixa- smoked product is not less than 100 tive, with sodium nitrate, in meat-cur- parts per million and not greater than ing preparations for the home curing of 200 parts per million, as measured in meat and meat products (including the loin muscle. poultry and wild game), with directions (c) Smoked chub shall be heated by a for use which limit the amount of so- controlled heat process which provides dium nitrite to not more than 200 parts a monitoring system positioned in as per million in the finished meat prod- many strategic locations in the smoke- uct, and the amount of sodium nitrate house as necessary to assure a contin- to not more than 500 parts per million uous temperature throughout each fish in the finished meat product. of at least 160 °F for a minimum of 30 (b) To assure safe use of the additive, minutes. in addition to the other information re- (d) The finished product shall be quired by the Act: cooled to a temperature of 50 °F or (1) The label of the additive or of a below within 3 hours after smoking and mixture containing the additive shall further cooled to a temperature of 38 °F bear: or below within 12 hours after smoking. (i) The name of the additive. A temperature of 38 °F or below shall (ii) A statement of the concentration be maintained during all subsequent of the additive in any mixture. storage and distribution. All shipping (2) If in a retail package intended for containers, retail packages, and ship- household use, the label and labeling of ping records shall indicate with appro- the additive, or of a mixture con- priate notice the perishable nature of taining the additive, shall bear ade- the product and specify that the prod- quate directions for use to provide a uct shall be held under refrigeration (38 final food product which complies with °F or below) until consumed. the limitations prescribed in paragraph (e) To assure safe use of the additive: (a) of this section. (1) The label and labeling of the addi- (3) If in a retail package intended for tive container shall bear, in addition to household use, the label of the addi- the other information required by the tive, or of a mixture containing the ad- Act, the name of the additive.
34
VerDate 06
(2) The label or labeling of the addi- used in food in accordance with the fol- tive container shall bear adequate di- lowing prescribed conditions: rections to assure use in compliance (a) The food additive has a melting with the provisions of this section. point of 149 °C–153 °C. (b) It is used as an antioxidant alone § 172.180 Stannous chloride. or in combination with other permitted The food additive stannous chloride antioxidants. may be safely used for color retention (c) The total antioxidant content of a in asparagus packed in glass, with lids food containing the additive will not lined with an inert material, in an exceed 0.02 percent of the oil or fat con- amount not to exceed 20 parts per mil- lion calculated as tin (Sn). tent of the food, including the essential (volatile) oil content of the food. § 172.185 TBHQ. The food additive TBHQ, which is the Subpart C—Coatings, Films and chemical 2-(1,1-dimethylethyl)-1,4-benz- Related Substances enediol (Chemical Abstracts Service Registry Number 1948–33–0), also known § 172.210 Coatings on fresh citrus fruit. as tertiary butylhydroquinone, may be Coatings may be applied to fresh cit- safely used in food in accordance with rus fruit for protection of the fruit in the following prescribed conditions: accordance with the following condi- (a) The food additive has a melting point of 126.5 °C–128.5 °C. tions: (b) It is used as an antioxidant alone (a) The coating is applied in the min- or in combination with BHA and/or imum amount required to accomplish BHT. the intended effect. (c) The total antioxidant content of a (b) The coating may be formulated food containing the additive will not from the following components, each exceed 0.02 percent of the oil or fat con- used in the minimum quantity required tent of the food, including the essential to accomplish the intended effect: (volatile) oil content of the food. (1) Substances generally recognized as safe for the purpose or previously § 172.190 THBP. sanctioned for the purpose. The food additive THBP (2,4,5-tri- (2) One or more of the following: hydroxybutyrophenone) may be safely
Component Limitations
Fatty acids ...... Complying with § 172.860. Oleic acid derived from tall oil fatty acids ...... Complying with § 172.862. Partially hydrogenated rosin ...... Catalytically hydrogenated to a maximum refractive index of 1.5012 at 100 °C. Color of WG or paler. Pentaerythritol ester of maleic anhydride-modi- Acid number of 134±145; drop-softening point of 127 °C±173 °C; saponifica- fied wood rosin. tion number of less than 280; and a color of M or paler. Do ...... Acid number of 176±186; drop-softening point of 110 °C±118 °C; 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.
35
VerDate 06
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. ons, limes, oranges, tangelos, and tan- The food additive coumarone-indene gerines whereby the maximum amount resin may be safely used on grapefruit, of the resin remaining on the fruit does lemons, limes, oranges, tangelos, and not exceed 200 parts per million on a tangerines in accordance with the fol- fresh-weight basis. lowing prescribed conditions: (d) To assure safe use of the additive: (a) The food additive is manufactured (1) The label of the market package by the polymerization of a crude, or any intermediate premix of the ad- heavy coal-tar solvent naphtha meet- ditive shall bear, in addition to the ing the following specifications: other information required by the act: (1) It is a mixture of indene, indan (i) The name of the additive, cou- (hydrindene), substituted benzenes, and marone-indene resin. related compounds. (ii) A statement of the concentration (2) It contains no more than 0.25 per- of the additive therein. cent tar bases. (2) The label or accompanying label- (3) 95 percent distills in the range 167 ing shall bear adequate directions that, °C–184 °C. if followed, will result in a finished (b) The food additive meets the fol- food not in conflict with the require- lowing specifications: ments of this section. (1) Softening point, ring and ball: 126 [42 FR 14491, Mar. 15, 1977, as amended at 49 °C minimum as determined by ASTM FR 10103, Mar. 19, 1984] method E28–67 (Reapproved 1982), ‘‘Standard Test Method for Softening § 172.225 Methyl and ethyl esters of Point by Ring-and-Ball Apparatus,’’ fatty acids produced from edible which is incorporated by reference. fats and oils. Copies may be obtained from the Amer- Methyl esters and ethyl esters of ican Society for Testing Materials, 1916 fatty acids produced from edible fats Race St., Philadelphia, PA 19103, or and oils may be safely used in food, may be examined at the Office of the subject to the following prescribed con- Federal Register, 800 North Capitol ditions: Street, NW., suite 700, Washington, DC (a) The additive consists of a mixture 20408. of either methyl or ethyl esters of (2) Refractive index (n 25/D) 1.63–1.64. fatty acids produced from edible fats (c) It is used or intended for use as a and oils and meets the following speci- protective coating for grapefruit, lem- fications:
36
VerDate 06
(1) Not less than 90 percent methyl or (b) The microcapsules produced from ethyl esters of fatty acids. the components listed in paragraphs (a) (2) Not more than 1.5 percent unsa- (1), (2), and (3) of this section may be ponifiable matter. used for encapsulating authorized fla- (b) The additive is used or intended voring oils for use, in accordance with for use at the level not to exceed 3 per- good manufacturing practice, in foods cent by weight in an aqueous emulsion for which standards of identity estab- in dehydrating grapes to produce rai- lished under section 401 of the Act do sins, whereby the residue of the addi- not preclude such use, except that tive on the raisins does not exceed 200 microcapsules formulated from compo- parts per million. nents listed in paragraph (a)(2) of this section may be used only for encap- [57 FR 12711, Apr. 13, 1992] sulating lemon oil, distilled lime oil, § 172.230 Microcapsules for flavoring orange oil, peppermint oil, and spear- substances. mint oil for use in dry mixes for pud- dings and gelatin desserts. Microcapsules may be safely used for (c) The microcapsules produced from encapsulating discrete particles of fla- the components listed in paragraphs (a) voring substances that are generally (1) and (4) of this section may be used recognized as safe for their intended only for encapsulating authorized use or are regulated under this part, in spice-flavoring substances for use, in accordance with the following condi- accordance with good manufacturing tions: practice, in frozen pizzas which are to (a) The microcapsules may be formu- be further processed by heat. Such piz- lated from the following components, zas shall bear labels or labeling includ- each used in the minimum quantity re- ing adequate directions for use to en- quired to accomplish the intended ef- sure heating to temperatures which fect: will melt the wax to release the spice- (1) Substances generally recognized flavoring substances. as safe for the purpose. (2) One or more of the following com- [45 FR 48123, July 18, 1980] ponents: § 172.235 Morpholine. COMPONENT AND LIMITATIONS Morpholine may be safely used as a Succinylated gelatin—Not to exceed 15 per- component of food, subject to the fol- cent by combined weight of the microcap- lowing restrictions. sule and flavoring oil. Succinic acid con- (a) It is used as the salt(s) of one or tent of the gelatin is 4.5 to 5.5 percent. more of the fatty acids meeting the re- Arabinogalactan—Complying with § 172.610; quirements of § 172.860, as a component as adjuvant. Silicon dioxide—Complying with § 172.480; as of protective coatings applied to fresh adjuvant. fruits and vegetables. (b) It is used at a level not in excess (3) In lieu of the components listed in of that reasonably required to produce paragraph (a)(2) of this section, the fol- its intended effect. lowing components: § 172.250 Petroleum naphtha. COMPONENT AND LIMITATIONS Petroleum naphtha may be safely Glutaraldehyde—As cross-linking agent for used in food in accordance with the fol- insolubilizing a coacervate of gum arabic lowing conditions: and gelatin. (a) The additive is a mixture of liquid n-Octyl alcohol—As a defoamer. hydrocarbons, essentially paraffinic (4) In lieu of the components listed in and naphthenic in nature obtained paragraphs (a)(2) and (3) of this section, from petroleum, the following component: (b) The additive is refined to meet the following specifications when sub- COMPONENT AND LIMITATIONS jected to the procedures described in Petroleum wax—Complying with § 172.886. this paragraph. Not to exceed 50 percent by combined (1) Boiling-point range: 175 °F–300 °F. weight of the microcapsule and spice-fla- (2) Nonvolatile residue: 0.002 gram voring substance. per 100 milliliters maximum.
37
VerDate 06
(3) Ultraviolet absorbance limits, as Absorbance accuracy, 1 ±0.05 at 0.4 absorb- follows: ance. Wavelength repeatability, ±0.2 millimicron. Maximum Wavelength accuracy, ±1.0 millimicron. absorb- Ultraviolet lamp. Long wavelength (3400– Wavelength (milli-microns) ance per centimeter 3800A°). optical pathlength REAGENTS 280±289 ...... 0.15 Isooctane (2,2,4-trimethylpentane). Use 180 290±299 ...... 13 milliliters in a 250-milliliter Erlenmeyer 300±359 ...... 08 flask, add 1 milliliter of purified n-hexa- 360±400 ...... 02 decane, insert the head assembly, allow ni- trogen gas to flow into the inlet tube and ANALYTICAL SPECIFICATION FOR PETROLEUM connect the outlet tube to a solvent trap and NAPHTHA vacuum line in such a way as to prevent any back flow of condensate into the flask. The GENERAL INSTRUCTIONS contents of the flask are evaporated on a All glassware should be scrupulously steam bath until 1 milliliter of residue re- cleaned to remove all organic matter such as mains. Dissolve the 1 milliliter of hexa- oil, grease, detergent residues, etc. Examine decane residue in isooctane and make up to all glassware, including stoppers and stop- 25 milliliters. Determine the absorbance in a cocks, under ultraviolet light to detect any 5-centimeter path length cell compared to residual fluorescent contamination. As a pre- isooctane as reference. The absorbance cautionary measure, it is recommended prac- should not exceed 0.01 per centimeter path tice to rinse all glassware with purified iso- length between 280–400 mµ. If necessary, iso- octane immediately before use. No grease is octane may be purified by passage through a to be used on stopcocks or joints. Great care column of activated silica gel (Grade 12, Da- to avoid contamination of petroleum naph- vidson Chemical Co., Baltimore, Md., or tha samples in handling and to assure ab- equivalent) or by distillation. sence of any extraneous material arising Methyl alcohol, A.C.S. reagent grade. Use 10 from inadequate packaging is essential. Be- milliliters and proceed as with isooctane. cause some of the polynuclear hydrocarbons The absorbance per centimeter of path sought in this test are very susceptible to length should be 0.00 between 280–400 mµ. photo-oxidation, the entire procedure is to Methyl alcohol may be purified by simple be carried out under subdued light. distillation or by refluxing in the presence of potassium hydroxide (10 grams/2 liters) and APPARATUS zinc dust (25 grams/2 liters) for 3 hours fol- lowed by distillation. Separatory funnels. 250-milliliter, and 2,000- n-Hexadecane, 99 percent olefin-free. Dilute milliliter capacity, equipped with tetra- 1.0 milliliter of n-hexadecane to 25 milliliters fluoroethylene polymer stopcocks. with isooctane and determine the absorbance Erlenmeyer flask. 125-milliliter with 24/40 in a 5-centimeter cell compared to isooctane standard taper neck. as reference between 280–400 mµ. The absorb- Evaporation flask. 250-milliliter capacity ance per centimeter path length shall not ex- all-glass flask equipped with 24/40 standard ceed 0.00 in this range. Purify, if necessary, taper stopper having inlet and outlet tubes by percolation through activated silica gel to permit passage of nitrogen across the sur- or by distillation. face of the container liquid to be evaporated. Sodium borohydride. 98 percent. Condenser. 24/40 joints, fitted with drying tube, length optional. Spectrophotometric cells. Fused quartz cells, 1 As determined by procedure using potas- optical path length in the range of 5,000 cen- sium chromate for reference standard and timeters ±0.005 centimeter; also for checking described in National Bureau of Standards spectrophotometer performance only, optical Circular 484, Spectrophotometry, U.S. De- path length in the range 1,000 centimeter partment of Commerce, (1949). The accuracy ±0.005 centimeter. With distilled water in the is to be determined by comparison with the cells, determine any absorbance difference. standard values at 290, 345, and 400 milli- Spectrophotometer. Spectral range 250–400 microns. The procedure is incorporated by mµ with spectral slit width of 2 mµ or less; reference. Copies of the material incor- under instrument operating conditions for porated by reference are available from the these absorbance measurements, the spectro- Center for Food Safety and Applied Nutri- photometer shall also meet the following tion (HFS–200), Food and Drug Administra- performance requirements: tion, 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of the Absorbance repeatability, ±0.01 at 0.4 absorb- Federal Register, 800 North Capitol Street, ance. NW., suite 700, Washington, DC 20408.
38
VerDate 06
Water. All distilled water must be ex- octane, swirl, and transfer to the first sepa- tracted with isooctane before use. A series of ratory funnel. Shake the funnel for 1 minute. three successive extracts of 1.5 liters of dis- After separation of the layers, draw off the tilled water with 100-milliliter portions of aqueous layer and discard. Transfer the iso- isooctane is satisfactory. octane layer to the volumetric flask and ad- just the volume to 25 milliliters of isooctane. PROCEDURE Mix the contents well, then transfer to the Determination of ultraviolet absorbance. Add first separatory funnel and wash twice with a 25-milliliter aliquot of the hydrocarbon 50-milliliter portions of distilled water. Dis- solvent together with 1 milliliter of hexa- card the aqueous layers after each wash. decane to the 125-milliliter Erlenmeyer Determine the ultraviolet absorbance of flask. While flushing with nitrogen, evapo- the isooctane extract in 5-centimeter path rate to 1 milliliter on a steam bath. Nitrogen is admitted through a 8±1-milliliter outer-di- length cells compared to isooctane as ref- µ ameter tube, drawn out into a 2±1-centimeter erence between 280–400 m . Determine a rea- long and 1±0.5-millimeter inner-diameter gent blank concurrently with the sample, capillary tip. This is positioned so that the using 25 milliliters of purified isooctane in- capillary tip extends 4 centimeters into the stead of a solvent sample and measuring the flask. The nitrogen flow rate is such that the ultraviolet absorbance of the blank between surface of the liquid is barely disturbed. 280–400mµ. After the volume is reduced to that of the 1 The reagent blank absorbance should not milliliter of hexadecane, the flask is left on exceed 0.04 per centimeter path length be- the steam bath for 10 more minutes before tween 280–289 mµ; 0.020 between 290–359 mµ; removing. Add 10 milliliters of purified iso- and 0.010 between 360–400 mµ. octane to the flask and reevaporate the solu- Determination of boiling-point range. Use tion to a 1-milliliter volume in the same ASTM method D86–82, ‘‘Standard Method for manner as described above, except do not Distillation of Petroleum Products,’’ which heat for an added 10 minutes. Repeat this op- eration twice more. Let the flask cool. is incorporated by reference. Copies may be Add 10 milliliters of methyl alcohol and obtained from the American Society for about 0.3 gram of sodium borohydride. (Mini- Testing Materials, 1916 Race St., Philadel- mize exposure of the borohydride to the at- phia, PA 19103, or may be examined at the mosphere; a measuring dipper may be used.) Office of the Federal Register, 800 North Cap- Immediately fit a water-cooled condenser itol Street, NW., suite 700, Washington, DC equipped with a 24/40 joint and with a drying 20408. tube into the flask, mix until the sodium Determination of nonvolatile residue. For hy- borohydride is dissolved, and allow to stand drocarbons boiling below 121 °C, determine for 30 minutes at room temperature, with the nonvolatile residue by ASTM method intermittent swirling. At the end of this D1353–78, ‘‘Standard Test Method for Non- time, disconnect the flask and evaporate the volatile Matter in Volatile Solvents for Use methyl alcohol on the steam bath under ni- in Paint, Varnish, Lacquer, and Related trogen until sodium borohydride begins to Products;’’ for those boiling above 121 °C, use drop out of solution. Remove the flask and ASTM method D381–80, ‘‘Standard Test let it cool. Add 6 milliliters of isooctane to the flask Method for Existent Gum in Fuels by Jet and swirl to wash the crystalline slurry. Evaporation,’’ which methods are incor- Carefully transfer the isooctane extract to a porated by reference. Copies may be obtained 250-milliliter separatory funnel. Dissolve the from the American Society for Testing Ma- crystals in the flask with about 25 milliliters terials, 1916 Race St., Philadelphia, PA 19103, of distilled water and pour this also into the or may be examined at the Office of the Fed- separatory funnel. Adjust the water volume eral Register, 800 North Capitol Street, NW., in the separatory funnel to about 100 milli- suite 700, Washington, DC 20408. liters and shake for 1 minute. After separa- tion of the layers, draw off the aqueous layer (c) Petroleum naphtha containing into a second 250-milliliter separatory fun- antioxidants shall meet the specified nel. Transfer the hydrocarbon layer in the ultraviolet absorbance limits after cor- first funnel to a 25-milliliter volumetric rection for any absorbance due to the flask. Carefully wash the Erlenmeyer flask with antioxidants. Petroleum naphtha may an additional 6 milliliters of isooctane, swirl, contain antioxidants authorized for use and transfer to the second separatory funnel. in food in an amount not to exceed Shake the funnel for 1 minute. After separa- that reasonably required to accomplish tion of the layers, draw off the aqueous layer the intended effect or to exceed any into the first separatory funnel. Transfer the prescribed limitations. isooctane in the second funnel to the volu- metric flask. Again wash the Erlenmeyer flask with an additional 6 milliliters of iso-
39
VerDate 06
(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 tive coatings on fresh citrus fruit in acid, of a mixture of butyl esters pro- compliance with § 172.210. duced by transesterification of an edi- ble vegetable oil using 1-butanol. Fol- [42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19, 1982; 49 FR 10104, Mar. 19, lowing sulfation, the reaction mixture 1984; 54 FR 24896, June 12, 1989] is washed with water and neutralized with aqueous sodium or potassium hy- § 172.255 Polyacrylamide. droxide. Prior to sulfation, the butyl oleate reaction mixture meets the fol- Polyacrylamide containing not more lowing specifications: than 0.2 percent of acrylamide mon- omer may be safely used as a film (1) Not less than 90 percent butyl ole- former in the imprinting of soft-shell ate. gelatin capsules when the amount used (2) Not more than 1.5 percent unsa- is not in excess of the minimum re- ponifiable matter. quired to produce the intended effect. (b) The additive is used or intended for use at a level not to exceed 2 per- § 172.260 Oxidized polyethylene. cent by weight in an aqueous emulsion in dehydrating grapes to produce rai- Oxidized polyethylene may be safely sins, whereby the residue of the addi- used as a component of food, subject to tive on the raisins does not exceed 100 the following restrictions: parts per million. (a) Oxidized polyethylene is the basic resin produced by the mild air oxida- [57 FR 12711, Apr. 13, 1992] tion of polyethylene. The polyethylene used in the oxidation process conforms § 172.275 Synthetic paraffin and suc- to the density, maximum n-hexane ex- cinic derivatives. tractable fraction, and maximum xy- Synthetic paraffin and succinic de- lene soluble fraction specifications pre- rivatives identified in this section may scribed in item 2.3 of the table in be safely used as a component of food, § 177.1520(c) of this chapter. The subject to the following restrictions: oxidized polyethylene has a minimum (a) The additive is prepared with 50 number average molecular weight of percent Fischer-Tropsch process syn- 1,200, as determined by high tempera- thetic paraffin, meeting the definition ture vapor pressure osmometry; con- and specifications of § 172.615, and 50 tains a maximum of 5 percent by percent of such synthetic paraffin to weight of total oxygen; and has an acid which is bonded succinic anhydride and value of 9 to 19. succinic acid derivatives of isopropyl (b) The additive is used or intended alcohol, polyethylene glycol, and poly- for use as a protective coating or com- propylene glycol. It consists of a mix- ponent of protective coatings for fresh ture of the Fischer-Tropsch process avocados, bananas, beets, coconuts, paraffin (alkane), alkyl succinic anhy- eggplant, garlic, grapefruit, lemons, dride, alkyl succinic anhydride iso- limes, mango, muskmelons, onions, or- propyl half ester, dialkyl succinic an- anges, papaya, peas (in pods), pine- hydride polyethylene glycol half ester, apple, plantain, pumpkin, rutabaga, and dialkyl succinic anhydride poly- squash (acorn), sweetpotatoes, tan- propylene glycol half ester, where the gerines, turnips, watermelon, Brazil alkane (alkyl) has a chain length of 30– nuts, chestnuts, filberts, hazelnuts, pe- 70 carbon atoms and the polyethylene cans, and walnuts (all nuts in shells). and polypropylene glycols have molec- (c) The additive is used in accordance ular weights of 600 and 260, respec- with good manufacturing practice and tively. in an amount not to exceed that re- (b) The additive meets the following quired to produce the intended effect. specifications: Molecular weight, 880– 930; melting point, 215°–217 °F; acid § 172.270 Sulfated butyl oleate. number, 43–47; and saponification num- Sulfate butyl oleate may be safely ber, 75–78. used in food, subject to the following (c) It is used or intended for use as a prescribed conditions: protective coating or component of
40
VerDate 06
protective coatings for fresh grape- (a) The additive is the product of the fruit, lemons, limes, muskmelons, or- controlled reaction between ascorbic anges, sweetpotatoes, and tangerines. acid and nicotinamide, melting in the (d) It is used in an amount not to ex- range 141 °C to 145 °C. ceed that required to produce the in- (b) It is used as a source of ascorbic tended effect. acid and nicotinamide in multivitamin preparations. § 172.280 Terpene resin. The food additive terpene resin may § 172.320 Amino acids. be safely used in accordance with the The food additive amino acids may following prescribed conditions: be safely used as nutrients added to (a) The food additive is the beta- foods in accordance with the following pinene polymer obtained by polym- conditions: erizing terpene hydrocarbons derived (a) The food additive consists of one from wood. It has a softening point of or more of the following individual 112 °C–118 °C, as determined by ASTM amino acids in the free, hydrated or an- method E28–67 (Reapproved 1982), hydrous form or as the hydrochloride, ‘‘Standard Test Method for Softening sodium or potassium salts: Point By Ring-and-Ball Apparatus,’’ L-Alanine which is incorporated by reference. L-Arginine Copies may be obtained from the Amer- L-Asparagine ican Society for Testing Materials, 1916 L-Aspartic acid Race St., Philadelphia, PA 19103, or L-Cysteine may be examined at the Office of the L-Cystine Federal Register, 800 North Capitol L-Glutamic acid L-Glutamine Street, NW., suite 700, Washington, DC Aminoacetic acid (glycine) 20408. L-Histidine (b) It is used or intended for use as L-Isoleucine follows: L-Leucine (1) As a moisture barrier on soft gela- L-Lysine tin capsules in an amount not to ex- DL-Methionine (not for infant foods) ceed 0.07 percent of the weight of the L-Methionine L-Phenylalanine capsule. L-Proline (2) As a moisture barrier on powders L-Serine of ascorbic acid or its salts in an L-Threonine amount not to exceed 7 percent of the L-Tryptophan weight of the powder. L-Tyrosine L-Valine [42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984] (b) The food additive meets the fol- lowing specifications: Subpart D—Special Dietary and (1) As found in ‘‘Food Chemicals Codex,’’ National Academy of Sciences/ Nutritional Additives National Research Council (NAS/NRC), § 172.310 Aluminum nicotinate. 3d Ed. (1981), which is incorporated by reference (copies may be obtained from Aluminum nicotinate may be safely the National Academy Press, 2101 Con- used as a source of niacin in foods for stitution Ave. NW., Washington, DC special dietary use. A statement of the 20418, or may be examined at the Office concentration of the additive, ex- of the Federal Register, 800 North Cap- pressed as niacin, shall appear on the itol Street, NW., suite 700, Washington, label of the food additive container or DC 20408) for the following: on that of any intermediate premix prepared therefrom. L-Alanine L-Arginine § 172.315 Nicotinamide-ascorbic acid L-Arginine Monohydrochloride complex. L-Cysteine Monohydrochloride L-Cystine Nicotinamide-ascorbic acid complex Aminoacetic acid (glycine) may be safely used in accordance with L-Leucine the following prescribed conditions: DL-Methionine
41
VerDate 06
L-Methionine (3) Each amino acid (or combination L-Tryptophan of the minimum number necessary to L-Phenylalanine achieve a statistically significant in- L-Proline L-Serine crease) added results in a statistically L-Threonine significant increase in the PER as de- Glutamic Acid Hydrochloride termined by the method described in L-Isoleucine paragraph (d) of this section. The min- L-Lysine Monohydrochloride imum amount of the amino acid(s) to Monopotassium L-glutamate achieve the desired effect must be used L-Tyrosine and the increase in PER over the pri- L-Valine marily-intact naturally occurring pro- (2) As found in ‘‘Specifications and tein in the food must be substantiated Criteria for Biochemical Compounds,’’ as a statistically significant difference NAS/NRC Publication, 3rd Ed. (1972), with at least a probability (P) value of which is incorporated by reference less than 0.05. (copies are available from the Center (4) The amount of the additive added for Food Safety and Applied Nutrition for nutritive purposes plus the amount (HFS–200), Food and Drug Administra- naturally present in free and combined tion, 200 C St. SW., Washington, DC (as protein) form does not exceed the 20204, or available for inspection at the following levels of amino acids ex- Office of the Federal Register, 800 pressed as percent by weight of the North Capitol Street, NW., suite 700, total protein of the finished food: Washington, DC 20408) for the fol- lowing: Percent by weight of L-Asparagine total pro- L-Aspartic acid tein (ex- pressed as L-Glutamine free amino L-Histidine acid)
(c) The additive(s) is used or intended L-Alanine ...... 6.1 for use to significantly improve the bi- L-Arginine ...... 6.6 ological quality of the total protein in L-Aspartic acid (including L-asparagine) ...... 7.0 a food containing naturally occurring L-Cystine (including L-cysteine) ...... 2.3 L-Glutamic acid (including L-glutamine) ...... 12.4 primarily-intact protein that is consid- Aminoacetic acid (glycine) ...... 3.5 ered a significant dietary protein L-Histidine ...... 2.4 source, provided that: L-Isoleucine ...... 6.6 (1) A reasonable daily adult intake of L-Leucine ...... 8.8 L-Lysine ...... 6.4 the finished food furnishes at least 6.5 L- and DL-Methionine ...... 3.1 grams of naturally occurring primarily L-Phenylalanine ...... 5.8 intact protein (based upon 10 percent of L-Proline ...... 4.2 the daily allowance for the ‘‘reference’’ L-Serine ...... 8.4 adult male recommended by the Na- L-Threonine ...... 5.0 L-Tryptophan ...... 1.6 tional Academy of Sciences in ‘‘Rec- L-Tyrosine ...... 4.3 ommended Dietary Allowances,’’ NAS L-Valine ...... 7.4 Publication No. 1694, 7th Ed. (1968), which is incorporated by reference. (d) Compliance with the limitations Copies are available from the Center concerning PER under paragraph (c) of for Food Safety and Applied Nutrition this section shall be determined by the (HFS–200), Food and Drug Administra- method described in sections 43.212– tion, 200 C St. SW., Washington, DC 43.216, ‘‘Official Methods of Analysis of 20204, or available for inspection at the the Association of Official Analytical Office of the Federal Register, 800 Chemists,’’ 13th Ed. (1980), which is in- North Capitol Street, NW., suite 700, corporated by reference. Copies may be Washington, DC 20408. obtained from the Association of Offi- (2) The additive(s) results in a pro- cial Analytical Chemists International, tein efficiency ratio (PER) of protein 481 North Frederick Ave., suite 500, in the finished ready-to-eat food equiv- Gaithersburg, MD 20877–2504, or may be alent to casein as determined by the examined at the Office of the Federal method specified in paragraph (d) of Register, 800 North Capitol Street, this section. NW., suite 700, Washington, DC 20408.
42
VerDate 06
Each manufacturer or person employ- after the mechanical rupture of yeast ing the additive(s) under the provisions cells of Saccharomyces cerevisiae and re- of this section shall keep and maintain moval of whole cell walls by cen- throughout the period of his use of the trifugation and separation of soluble additive(s) and for a minimum of 3 cellular materials. years thereafter, records of the tests (b) The additive meets the following required by this paragraph and other specifications on a dry weight basis: records required to assure effectiveness (1) Zinc salts less than 500 parts per and compliance with this regulation million (ppm) as zinc. and shall make such records available (2) Nucleic acid less than 2 percent. upon request at all reasonable hours by any officer or employee of the Food (3) Less than 0.3 ppm arsenic, 0.1 ppm and Drug Administration, or any other cadmium, 0.4 ppm lead, 0.05 ppm mer- officer or employee acting on behalf of cury, and 0.3 ppm selenium. the Secretary of Health and Human (c) The viable microbial content of Services and shall permit such officer the finished ingredient is: or employee to conduct such inven- (1) Less than 10,000 organisms/gram tories of raw and finished materials on by aerobic plate count. hand as he deems necessary and other- (2) Less than 10 yeasts and molds/ wise to check the correctness of such gram. records. (3) Negative for Salmonella, E. coli, (e) To assure safe use of the additive, coagulase positive Staphylococci, Clos- the label and labeling of the additive tridium perfringens, Clostridium botu- and any premix thereof shall bear, in linum, or any other recognized micro- addition to the other information re- bial pathogen or any harmful microbial quired by the Act, the following: toxin. (1) The name of the amino acid(s) (d) The ingredient is used in food as contained therein including the spe- cific optical and chemical form. a nutrient supplement as defined in (2) The amounts of each amino acid § 170.3(o)(20) of this chapter. contained in any mixture. (3) Adequate directions for use to § 172.330 Calcium pantothenate, cal- cium chloride double salt. provide a finished food meeting the limitations prescribed by paragraph (c) The food additive calcium chloride of this section. double salt of calcium pantothenate (f) The food additive amino acids may be safely used in foods for special added as nutrients to special dietary dietary uses in accordance with good foods that are intended for use solely manufacturing practice and under the under medical supervision to meet nu- following prescribed conditions: tritional requirements in specific med- (a) The food additive is of the d (dex- ical conditions and comply with the re- trorotatory) or the dl (racemic) form. quirements of part 105 of this chapter (b) To assure safe use of the additive, are exempt from the limitations in the label and labeling of the food addi- paragraphs (c) and (d) of this section tive container, or that of any inter- and may be used in such foods at levels mediate premixes prepared therefrom, not to exceed good manufacturing shall bear, in addition to the other in- practices. formation required by the Act, the fol- [42 FR 14491, Mar. 15, 1977; 42 FR 56728, Oct. lowing: 28, 1977, as amended at 47 FR 11836, Mar. 19, (1) The name of the additive ‘‘cal- 1982; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 59 FR 14550, Mar. 29, 1994; 61 FR cium chloride double salt of d-calcium 14480, Apr. 2, 1996] pantothenate’’ or ‘‘calcium chloride double salt of dl-calcium panto- § 172.325 Bakers yeast protein. thenate’’, whichever is appropriate. Bakers yeast protein may be safely (2) A statement of the appropriate used in food in accordance with the fol- concentration of the additive, ex- lowing conditions: pressed as pantothenic acid. (a) Bakers yeast protein is the insol- uble proteinaceous material remaining
43
VerDate 06
§ 172.335 D-Pantothenamide. (2) Moisture content shall not be more than 10 percent by weight of the The food additive D-pantothenamide final product, as determined by the as a source of pantothenic acid activ- method described in section 24.003, Air ity, may be safely used in foods for spe- Drying (1)—Official First Action. cial dietary use in an amount not in (3) Fat content shall not be more excess of that reasonably required to than 0.5 percent by weight of the final produce its intended effect. product, as determined by the method described in section 24.005, Crude Fat § 172.340 Fish protein isolate. or Ether Extract—Official Final Ac- (a) The food additive fish protein iso- tion. late may be safely used as a food sup- (4) Solvent residues in the final prod- plement in accordance with the fol- uct shall not be more than 5 parts per lowing prescribed conditions: million of hexane and 3.5 percent eth- (1) The additive shall consist prin- anol by weight. cipally of dried fish protein prepared [46 FR 38072, July 24, 1981, as amended at 47 from the edible portions of fish after FR 53344, Nov. 26, 1982; 54 FR 24897, June 12, removal of the heads, fins, tails, bones, 1989] scales, viscera, and intestinal contents. (2) The additive shall be derived only § 172.345 Folic acid (folacin). from species of bony fish that are gen- Folic acid (CAS Reg. No. 59–30–3), erally recognized by qualified sci- also known as folacin or folate, may be entists as safe for human consumption safely used in food as a nutrient in ac- and that can be processed as prescribed cordance with the following prescribed to meet the required specifications. conditions: (3) Only wholesome fresh fish other- (a) Folic acid is the chemical N-[4- wise suitable for human consumption [[(2-amino-1,4-dihydro-4-oxo-6-pteri- may be used. The fish shall be handled dinyl)methyl]amino]benzoyl]-L-glu- expeditiously under sanitary condi- tamic acid. tions. These conditions shall be in ac- (b) Folic acid meets the specifica- cordance with recognized good manu- tions of the ‘‘Food Chemicals Codex,’’ facturing practice for fish to be used as 4th ed. (1996), pp. 157–158, which is in- human food. corporated by reference in accordance (4) The additive shall be prepared by with 5 U.S.C. 552(a) and 1 CFR part 51. extraction with hexane and food-grade Copies are available from the National ethanol to remove fat and moisture. Academy Press, Box 285, 2101 Constitu- Solvent residues shall be reduced by tion Ave. NW., Washington, DC 20055 drying. (Internet address ‘‘http:// (b) The food additive meets the fol- www.nap.edu’’), or may be examined at lowing specifications: (Where methods the Center for Food Safety and Applied of determination are specified, they are Nutrition’s Library, Food and Drug Ad- Association of Official Analytical ministration, 200 C St. SW., rm. 3321, Chemists Methods, 13th ed., 1980, which Washington, DC, or at the Office of the are incorporated by reference). 1 Federal Register, 800 North Capitol St. (1) Protein content, as N × 6.25, shall NW., suite 700, Washington, DC. not be less than 90 percent by weight of (c) Folic acid may be added to foods the final product, as determined by the subject to a standard of identity estab- method described in section 2.057, Im- lished under section 401 of the Federal proved Kjeldahl Method for Nitrate- Food, Drug, and Cosmetic Act (the act) Free Samples (20)—Official Final Ac- when the standard of identity specifi- tion. cally provides for the addition of folic acid. (d) Folic acid may be added, at levels 1 Copies are available from: Association of not to exceed 400 micrograms (µg) per Official Analytical Chemists International, serving, to breakfast cereals, as defined 481 North Frederick Ave., suite 500, Gaithers- burg, MD 20877–2504, or examined at the Of- under § 170.3(n)(4) of this chapter, and fice of the Federal Register, 800 North Cap- to corn grits at a level such that each itol Street, NW., suite 700, Washington, DC pound of corn grits contains not more 20408. than 1.0 milligram of folic acid.
44
VerDate 06
(e) Folic acid may be added to infant (c) Ferrous fumarate is used as a formula in accordance with section source of iron in foods for special die- 412(i)(1) of the act or with regulations tary use, when the use is consistent issued under section 412(i)(2) of the act with good nutrition practice. which are codified in § 107.100 of this chapter. § 172.365 Kelp. (f) Folic acid may be added to a med- Kelp may be safely added to a food as ical food, as defined in section 5(b)(3) of a source of the essential mineral io- the Orphan Drug Act (21 U.S.C. dine, provided the maximum intake of 360ee(b)(3)), at levels not to exceed the the food as may be consumed during a amount necessary to meet the distinc- period of one day, or as directed for use tive nutritional requirements of the in the case of a dietary supplement, disease or condition for which the food will not result in daily ingestion of the is formulated. additive so as to provide a total (g) Folic acid may be added to food amount of iodine in excess of 225 for special dietary use at levels not to micrograms for foods labeled without exceed the amount necessary to meet reference to age or physiological state; the special dietary needs for which the and when age or the conditions of preg- food is formulated. nancy or lactation are specified, in ex- (h) Folic acid may be added to foods cess of 45 micrograms for infants, 105 represented as meal-replacement prod- micrograms for children under 4 years ucts, in amounts not to exceed: µ of age, 225 micrograms for adults and (1) Four hundred g per serving if the children 4 or more years of age, and 300 food is a meal-replacement that is rep- micrograms for pregnant or lactating resented for use once per day; or women. The food additive kelp is the (2) Two hundred µg per serving if the dehydrated, ground product prepared food is a meal-replacement that is rep- from Macrocystis pyrifera, Laminaria resented for use more than once per digitata, Laminaria saccharina, and Lam- day. inaria cloustoni. [61 FR 8807, Mar. 5, 1996, as amended at 61 FR 27779, June 3, 1996; 64 FR 1758, Jan. 12, 1999] § 172.370 Iron-choline citrate complex. § 172.350 Fumaric acid and salts of fu- Iron-choline citrate complex made by maric acid. reacting approximately equimolecular quantities of ferric hydroxide, choline, Fumaric acid and its calcium, fer- and citric acid may be safely used as a rous, magnesium, potassium, and so- source of iron in foods for special die- dium salts may be safely used in food tary use. in accordance with the following pre- scribed conditions: § 172.372 N-Acetyl-L-methionine. (a) The additives meet the following specifications: The food additive N-acetyl-L-methio- (1) Fumaric acid contains a minimum nine may be safely added to food (ex- of 99.5 percent by weight of fumaric cept infant foods and foods containing acid, calculated on the anhydrous added nitrites/nitrates) as a source of basis. L-methionine for use as a nutrient in (2) The calcium, magnesium, potas- accordance with the following condi- sium, and sodium salts contain a min- tions: imum of 99 percent by weight of the re- (a) N-Acetyl-L-methionine (Chemical spective salt, calculated on the anhy- Abstracts Service Registry No. 65–82–7) drous basis. Ferrous fumarate contains is the derivative of the amino acid me- a minimum of 31.3 percent total iron thionine formed by addition of an and not more than 2 percent ferric acetyl group to the alpha-amino group iron. of methionine. It may be in the free, (b) With the exception of ferrous fu- hydrated or anhydrous form, or as the marate, fumaric acid and the named sodium or potassium salts. salts are used singly or in combination (b) The additive meets the following in food at a level not in excess of the specifications: amount reasonably required to accom- (1) Purity assay, on a dry basis: Min- plish the intended effect. imum 99 percent.
45
VerDate 06
(2) Residue on ignition: Maximum 0.1 corporated by reference. Copies may be percent. obtained from the Association of Offi- (3) Specific optical rotation cial Analytical Chemists International, 20 [alpha] D: Between ¥19° and ¥23°. 481 North Frederick Ave., suite 500, (4) The additive may contain residues Gaithersburg, MD 20877–2504, or may be of not more than 500 ppm ethyl ace- examined at the Office of the Federal tate; 50 ppm ethyl alcohol; 10 ppm Register, 800 North Capitol Street, methyl alcohol; and 10 ppm acetone, NW., suite 700, Washington, DC 20408. when used as processing solvents. Each manufacturer or person employ- (c) The additive is used or intended ing the additive under the provisions of for use as a source of L-methionine to this section shall keep and maintain improve significantly the biological throughout the period of use of the ad- quality of the total protein in a food ditive and for a minimum of 3 years containing naturally occurring pri- marily intact vegetable protein that is thereafter, records of the tests required considered a significant dietary protein by this paragraph and other records re- source, provided that: quired to assure effectiveness and com- (1) A reasonable daily adult intake of pliance with this regulation. Those the finished food furnishes at least 6.5 records shall be made available upon grams of naturally occurring primarily request at all reasonable hours by any intact vegetable protein. officer or employee acting on behalf of (2) The additive results in a protein the Secretary of Health and Human efficiency ratio (PER) of protein in the Services. Those officers or employees finished ready-to-eat food equivalent shall be permitted to conduct inven- to casein as determined by the method tories of raw and finished materials on specified in paragraph (d) of this sec- hand as are deemed necessary to verify tion. the records. (3) The use of the additive results in (e) To assure safe use of the additive, a statistically significant increase in the label and labeling of the additive the PER as determined by the method and any premix thereof shall bear, in described in paragraph (d) of this sec- addition to the other information re- tion. The minimum amount of the ad- quired by the Act, the following: ditive to achieve the desired effect (1) The name of the additive con- must be used, and the increase in PER tained therein. over the primarily intact naturally oc- curring vegetable protein in the food (2) The amounts of additive and each must be substantiated as a statis- amino acid contained in any mixture. tically significant difference with at (3) Adequate directions for use to least a probability (P) value of less provide a finished food meeting the than 0.05. limitations prescribed by paragraph (c) (4) The amount of the additive added of this section. for nutritive purpose shall not exceed (f) When the food additive is added as the level that will provide a total of 3.1 a nutrient to special dietary foods that percent L- and DL-methionine (ex- are intended for use solely under med- pressed as the free amino acid) by ical supervision to meet nutritional re- weight of the total protein of the fin- quirements in specific medical condi- ished food, including the amount natu- tions and these foods comply with the rally present in free and combined (as requirements of part 105 of this chap- protein) form. ter, the food additive is exempt from (5) The additive shall not be added to the limitations in paragraphs (c)(1) infant foods or to foods containing through (4) and (d) of this section and added nitrites/nitrates. may be used in those foods at levels (d) Compliance with the limitations not to exceed good manufacturing concerning PER under paragraph (c) of practices. the section shall be determined by the method described in sections 43.212– [43 FR 27784, June 27, 1978, as amended at 46 43.216, ‘‘Official Methods of Analysis of FR 59968, Dec. 8, 1981; 49 FR 10104, Mar. 19, the Association of Official Analytical 1984; 54 FR 24897, June 12, 1989] Chemists,’’ 13th Ed. (1980), which is in-
46
VerDate 06
§ 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 or as directed for use in the case of a ‘‘Official Methods of Analysis of the dietary supplement, will not result in Association of Official Analytical daily ingestion of the additive so as to Chemists’’ (AOAC), 13th Ed. (1980). Pro- provide a total amount of iodine in ex- tein quality shall not be less than 100, cess of 225 micrograms for foods labeled as determined by the method described without reference to age or physio- in sections 43.212–43.216 of the AOAC. logical state; and when age or the con- The 13th Ed. is incorporated by ref- ditions of pregnancy or lactation are erence, and copies may be obtained specified, in excess of 45 micrograms from the Association of Official Ana- for infants, 105 micrograms for children lytical Chemists International, 481 under 4 years of age, 225 micrograms North Frederick Ave., suite 500, Gai- for adults and children 4 or more years thersburg, MD 20877–2504, or may be ex- of age, and 300 micrograms for preg- amined at the Office of the Federal nant or lactating women. Register, 800 North Capitol Street, (b) To assure safe use of the additive, NW., suite 700, Washington, DC 20408. in addition to the other information re- (2) Moisture content shall not exceed quired by the Act, the label of the addi- 10 percent by weight of the final prod- tive shall bear: uct, as determined by the method de- (1) The name of the additive. scribed in section 24.003 of the AOAC. (2) A statement of the concentration See paragraph (c)(1) of this section for of the additive in any mixture. availability of the material incor- porated by reference. § 172.385 Whole fish protein con- (3) Fat content shall not exceed 0.5 centrate. percent by weight of the final product, The food additive whole fish protein as determined by the method described concentrate may be safely used as a in section 24.005 of the AOAC. See para- food supplement in accordance with graph (c)(1) of the this section for the following prescribed conditions: availability of the material incor- (a) The additive is derived from porated by reference. whole, wholesome hake and hakelike (4) The additive may contain residues fish, herring of the genera Clupea, men- of isopropyl alcohol and ethylene di- haden, and anchovy of the species En- chloride not in excess of 250 parts per graulis mordax, handled expeditiously million and 5 parts per million, respec- and under sanitary conditions in ac- tively, when used as solvents in the ex- cordance with good manufacturing traction process. practices recognized as proper for fish (5) Microwave radiation meeting the that are used in other forms for human requirements of § 179.30 of this chapter food. may be used to reduce residues of the (b) The additive consists essentially solvents used in the extraction process. of a dried fish protein processed from (6) The additive shall contain not in the whole fish without removal of excess of 100 parts per million fluorides heads, fins, tails, viscera, or intestinal (expressed as F). contents. It is prepared by solvent ex- (7) The additive shall be free of Esch- traction of fat and moisture with iso- erichia coli and pathogenic organisms, propyl alcohol or with ethylene dichlo- including Salmonella, and shall have a ride followed by isopropyl alcohol, ex- total bacterial plate count of not more cept that the additive derived from than 10,000 per gram. herring, menhaden and anchovy is pre- (8) The additive shall have no more pared by solvent extraction with iso- than a faint characteristic fish odor propyl alcohol alone. Solvent residues and taste.
47
VerDate 06
(d) When the additive is used or in- (c) The additive is used in tablet form tended for use in the household as a as a source of dietary zinc. protein supplement in food for regular [46 FR 58297, Dec. 1, 1981] consumption by children up to 8 years of age, the amount of the additive from this source shall not exceed 20 grams Subpart E—Anticaking Agents per day (about one heaping table- spoon). § 172.410 Calcium silicate. (e) When the additive is used as a Calcium silicate, including synthetic protein supplement in manufactured calcium silicate, may be safely used in food, the total fluoride content (ex- food in accordance with the following pressed as F) of the finished food shall prescribed conditions: not exceed 8 ppm based on the dry (a) It is used as an anticaking agent weight of the food product. in food in an amount not in excess of (f) To assure safe use of the additive, that reasonably required to produce its in addition to the other information re- intended effect. quired by the Act: (b) It will not exceed 2 percent by (1) The label of consumer-sized or weight of the food, except that it may bulk containers of the additive shall be present up to 5 percent by weight of bear the name ‘‘whole fish protein con- baking powder. centrate’’. (2) The label or labeling of containers § 172.430 Iron ammonium citrate. of the additive shall bear adequate di- Iron ammonium citrate may be safe- rections for use to comply with the ly used in food in accordance with the limitations prescribed by paragraphs following prescribed conditions: (d) and (e) of this section. (a) The additive is the chemical (3) Labels of manufactured foods con- green ferric ammonium citrate. taining the additive shall bear, in the (b) The additive is used, or intended ingredient statement, the name of the for use as an anticaking agent in salt additive, ‘‘whole fish protein con- for human consumption so that the centrate’’ in the proper order of de- level of iron ammonium citrate does creasing predominance in the finished not exceed 25 parts per million (0.0025 food. percent) in the finished salt. [42 FR 14491, Mar. 15, 1977, as amended at 49 (c) To assure safe use of the additive FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, the label or labeling of the additive 1989] shall bear, in addition to the other in- formation required by the Act: § 172.395 Xylitol. (1) The name of the additive. Xylitol may be safely used in foods (2) Adequate directions to provide a for special dietary uses, provided the final product that complies with the amount used is not greater than that limitations prescribed in paragraph (b) required to produce its intended effect. of this section.
§ 172.399 Zinc methionine sulfate. § 172.480 Silicon dioxide. Zinc methionine sulfate, CAS Reg. The food additive silicon dioxide may No. 56329–42–1, may be safely used in be safely used in food in accordance accordance with the following pre- with the following conditions: scribed conditions: (a) The food additive is manufactured (a) The additive is the product of the by vapor phase hydrolysis or by other reaction between equimolar amounts of means whereby the particle size is such zinc sulfate and DL-methionine in puri- as to accomplish the intended effect. fied water. (b) It is used as an anticaking agent, (b) The additive meets the following subject to the following conditions: specifications: (1) It is used in only those foods in which the additive has been dem- Zinc content—19 to 22 percent. onstrated to have an anticaking effect. C5H11NO2S ‘‘DL-methionine’’—46 to 50 per- cent. (2) It is used in an amount not in ex- Cadmium—not more than 0.05 part per mil- cess of that reasonably required to lion. produce its intended effect.
48
VerDate 06
(3) [Reserved] Subpart F—Flavoring Agents and (4) It is used in an amount not to ex- Related Substances ceed 2 percent by weight of the food. (c) It is used or intended for use as a § 172.510 Natural flavoring substances stabilizer in the production of beer, and and natural substances used in con- is removed from the beer by filtration junction with flavors. prior to final processing. (d) It is used or intended for use as an Natural flavoring substances and adsorbent for dl-a-tocopheryl acetate natural adjuvants may be safely used and pantothenyl alcohol in tableted in food in accordance with the fol- foods for special dietary use, in an lowing conditions. amount not greater than that required (a) They are used in the minimum to accomplish the intended physical or quantity required to produce their in- technical effect. tended physical or technical effect and in accordance with all the principles of § 172.490 Yellow prussiate of soda. good manufacturing practice. (a) The food additive yellow prussiate (b) In the appropriate forms (plant of soda (sodium ferrocyanide decahy- parts, fluid and solid extracts, con- drate; Na4Fe(CN)6·10H2O contains a cretes, absolutes, oils, gums, balsams, minimum of 99 percent by weight of so- resins, oleoresins, waxes, and dis- dium ferrocyanide decahydrate. tillates) they consist of one or more of (b) The additive is used or intended the following, used alone or in com- for use as an anticaking agent in salt bination with flavoring substances and and as an adjuvant in the production of adjuvants generally recognized as safe dendritic crystals of salt in an amount needed to produce its intended effect in food, previously sanctioned for such but not in excess of 13 parts per million use, or regulated in any section of this calculated as anhydrous sodium ferro- part. cyanide. [42 FR 14491, Mar. 15, 1977, as amended at 58 FR 17098, Apr. 1, 1993]
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
49
VerDate 06
Common name Scientific name Limitations
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. 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.
50
VerDate 06
Common name Scientific name Limitations
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 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.
51
VerDate 06
Common name Scientific name Limitations
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- Allyl sulfide. stances and adjuvants. Allyl tiglate; allyl trans-2-methyl-2- butenoate. Synthetic flavoring substances and Allyl 10-undecenoate. adjuvants may be safely used in food in Ammonium isovalerate. accordance with the following condi- Ammonium sulfide. tions. Amyl alcohol; pentyl alcohol. (a) They are used in the minimum Amyl butyrate. quantity required to produce their in- α-Amylcinnamaldehyde. tended effect, and otherwise in accord- α-Amylcinnamaldehyde dimethyl acetal. ance with all the principles of good α-Amylcinnamyl acetate. α-Amylcinnamyl alcohol. manufacturing practice. α (b) They consist of one or more of the -Amylcinnamyl formate. α-Amylcinnamyl isovalerate. following, used alone or in combination Amyl formate. with flavoring substances and adju- Amyl heptanoate. vants generally recognized as safe in Amyl hexanoate. food, prior-sanctioned for such use, or Amyl octanoate. regulated by an appropriate section in Anisole; methoxybenzene. this part. Anisyl acetate. Anisyl alcohol; p-methoxybenzyl alcohol. Acetal; acetaldehyde diethyl acetal. Anisyl butyrate Acetaldehyde phenethyl propyl acetal. Anisyl formate. ′ Acetanisole; 4 -methoxyacetophenone. Anisyl phenylacetate. Acetophenone; methyl phenyl ketone. Anisyl propionate. Allyl anthranilate. Beechwood creosote. Allyl butyrate. Benzaldehyde dimethyl acetal. Allyl cinnamate. Benzaldehyde glyceryl acetal; 2-phenyl-m-di- Allyl cyclohexaneacetate. oxan-5-ol. Allyl cyclohexanebutyrate. Benzaldehyde propylene glycol acetal; 4- Allyl cyclohexanehexanoate. Allyl cyclohexaneproprionate. methyl-2-phenyl-m-dioxolane. Allyl cyclohexanevalerate. Benzenethiol; thiophenol. Allyl disulfide. Benzoin; 2-hydroxy-2-phenylacetophenone. Allyl 2-ethylbutyrate. Benzophenone; diphenylketone. Allyl hexanoate; allyl caproate. Benzyl acetate. Allyl α-ionone; 1-(2,6,6-trimethyl-2-cyclo-hex- Benzyl acetoacetate. ene-1-yl)-1,6-heptadiene-3-one. Benzyl alcohol. Allyl isothiocyanate; mustard oil. Benzyl benzoate. Allyl isovalerate. Benzyl butyl ether. Allyl mercaptan; 2-propene-1-thiol. Benzyl butyrate. Allyl nonanoate. Benzyl cinnamate. Allyl octanoate. Benzyl 2,3–dimethylcrotonate; benzyl methyl Allyl phenoxyacetate. tiglate. Allyl phenylacetate. Benzyl disulfide; dibenzyl disulfide. Allyl propionate. Benzyl ethyl ether. Allyl sorbate; allyl 2,4-hexadienoate. Benzyl formate.
52
VerDate 06
3-Benzyl-4-heptanone; benzyl dipropyl ke- β-Caryophyllene oxide; 4-12,12-trimethyl-9- tone. methylene-5-oxatricylo [8.2.0.04, 6] dode- Benzyl isobutyrate. cane. Benzyl isovalerate. Cedarwood oil alcohols. Benzyl mercaptan; α-toluenethiol. Cedarwood oil terpenes. Benzyl methoxyethyl acetal; acetaldehyde 1,4-Cineole. benzyl β-methoxyethyl acetal. Cinnamaldehyde ethylene glycol acetal. Benzyl phenylacetate. Cinnamic acid. Benzyl propionate. Cinnamyl acetate. Benzyl salicylate. Cinnamyl alcohol; 3-phenyl-2-propen-1-ol. Birch tar oil. Cinnamyl benzoate. Borneol; d-camphanol. Cinnamyl butyrate. Bornyl acetate. Cinnamyl cinnamate. Bornyl formate. Cinnamyl formate. Bornyl isovalerate. Cinnamyl isobutyrate. Bornyl valerate. Cinnamyl isovalerate. β-Bourbonene; 1,2,3,3a,3bβ,4,5,6,6aβ,6bα-deca- Cinnamyl phenylacetate. Cinnamyl propionate. hydro-lα-isopropyl-3aa-methyl-6-meth- ylene-cyclobuta [1,2:3,4] dicyclopentene. Citral diethyl acetal; 3,7-dimethyl-2,6-octa- 2-Butanol. dienal diethyl acetal. 2-Butanone; methyl ethyl ketone. Citral dimethyl acetal; 3,7-dimethyl-2,6-octa- Butter acids. dienal dimethyl acetal. Citral propylene glycol acetal. Butter esters. Citronellal; 3,7-dimethyl-6-octenal; rhodinal. Butyl acetate. Citronellol; 3,7-dimethyl-6-octen-1-ol; d-cit- Butyl acetoacetate. ronellol. Butyl alcohol; 1-butanol. Citronelloxyacetaldehyde. Butyl anthranilate. Citronellyl acetate. Butyl butyrate. Citronellyl butyrate. Butyl butyryllactate; lactic acid, butyl Citronellyl formate. ester, butyrate. Citronellyl isobutyrate. α -Butylcinnamaldehyde. Citronellyl phenylacetate. Butyl cinnamate. Citronellyl propionate. Butyl 2-decenoate. Citronellyl valerate. Butyl ethyl malonate. p-Cresol. Butyl formate. Cuminaldehyde; cuminal; p-isopropyl benz- Butyl heptanoate. aldehyde. Butyl hexanoate. Cyclohexaneacetic acid. Butyl p-hydroxybenzoate. Cyclohexaneethyl acetate. Butyl isobutyrate. Cyclohexyl acetate. Butyl isovalerate. Cyclohexyl anthranilate. Butyl lactate. Cyclohexyl butyrate. Butyl laurate. Cyclohexyl cinnamate. Butyl levulinate. Cyclohexyl formate. Butyl phenylacetate. Cyclohexyl isovalerate. Butyl propionate. Cyclohexyl propionate. Butyl stearate. p-Cymene. Butyl sulfide. γ-Decalactone; 4-hydroxy-decanoic acid, γ- Butyl 10-undecenoate. lactone. Butyl valerate. γ-Decalactone; 5-hydroxy-decanoic acid, δ- Butyraldehyde. lactone. Cadinene. Decanal dimethyl acetal. Camphene; 2,2-dimethyl-3-methylene- 1-Decanol; decylic alcohol. norbornane. 2-Decenal. d-Camphor. 3-Decen-2-one; heptylidene acetone. Carvacrol; 2-p-cymenol. Decyl actate. Carvacryl ethyl ether; 2-ethoxy-p-cymene. Decyl butyrate. Carveol; p-mentha-6,8-dien-2-ol. Decyl propionate. 4-Carvomenthenol; 1-p-menthen-4-ol; 4- Dibenzyl ether. terpinenol. 4,4-Dibutyl-γ-butyrolactone; 4,4-dibutyl-4-hy- cis Carvone oxide; 1,6-epoxy-p-menth-8-en-2- droxy-butyric acid, γ-lactone. one. Dibutyl sebacate. Carvyl acetate. Diethyl malate. Carvyl propionate. Diethyl malonate; ethyl malonate. β-Caryophyllene. Diethyl sebacate. Caryophyllene alcohol. Diethyl succinate. Caryophyllene alcohol acetate. Diethyl tartrate.
53
VerDate 06
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. α,α-Dimethylbenzyl isobutyrate; phenyldi- Ethyl 3-phenylglycidate. methylcarbinyl isobutyrate. Ethyl 3-phenylpropionate; ethyl hydro- 2,6-Dimethyl-5-heptenal. cinnamate. 2,6-Dimethyl octanal; isodecylaldehyde. Ethyl propionate. 3,7-Dimethyl-1-octanol; tetrahydrogeraniol. Ethyl pyruvate. α,α-Dimethylphenethyl acetate; benzyl- Ethyl salicylate. propyl acetate; benzyldimethylcarbinyl ac- Ethyl sorbate; ethyl 2,4-hexadienoate. etate. Ethyl tiglate; ethyl trans-2-methyl-2- α,α-Dimethylphenethyl alcohol; dimethyl- butenoate. benzyl carbinol. Ethyl undecanoate. α,α-Dimethylphenethyl butyrate; benzyl- Ethyl 10-undecenoate. dimethylcarbinyl butyrate. Ethyl valerate. α,α-Dimethylphenethyl formate; benzyldi- Eucalyptol; 1,8-epoxy-p-menthane; cineole. methylcarbinyl formate. Eugenyl acetate. Dimethyl succinate. Eugenyl benzoate. 1,3-Diphenyl-2-propanone; dibenzyl ketone. Eugenyl formate. delta-Dodecalactone; 5-hydroxydodecanoic Eugenyl methyl ether; 4-allylveratrole; acid, deltalactone. methyl eugenol. γ-Dodecalactone; 4-hydroxydodecanoic acid γ- Farnesol; 3,7,11-trimethyl-2,6,10-dodecatrien- lactone. 1-ol. 2-Dodecenal. d-Fenchone; d-1,3,3-trimethyl-2-nor- Estragole. bornanone. ρ-Ethoxybenzaldehyde. Fenchyl alcohol; 1,3,3-trimethyl-2-nor- Ethyl acetoacetate. bornanol. Ethyl 2-acetyl-3-phenylpropionate; ethyl- Formic acid benzyl acetoacetate. (2-Furyl)-2-propanone; furyl acetone. Ethyl aconitate, mixed esters. 1-Furyl-2-propanone; furyl acetone. Ethyl acrylate. Fusel oil, refined (mixed amyl alcohols). Ethyl ρ-anisate. Geranyl acetoacetate; trans-3,7-dimethyl-2, 6- Ethyl anthranilate. octadien-1-yl acetoacetate. Ethyl benzoate. Geranyl acetone; 6,10-dimethyl-5,9- Ethyl benzoylacetate. undecadien-2-one. α-Ethylbenzyl butyrate; α-phenylpropyl bu- Geranyl benzoate. tyrate. Geranyl butyrate. Ethyl brassylate; tridecanedioic acid cyclic Geranyl formate. ethylene glycol diester; cyclo 1,13-ethyl- Geranyl hexanoate enedioxytridecan-1,13-dione. Geranyl isobutyrate. 2-Ethylbutyl acetate. Geranyl isovalerate. 2-Ethylbutyraldehyde. Geranyl phenylacetate. 2-Ethylbutyric acid. Geranyl propionate. Ethyl cinnamate. Glucose pentaacetate. Ethyl crotonate; trans-2-butenoic acid ethyl- Guaiacol; µ -methoxyphenol. ester. Guaiacyl acetate; µ -methoxyphenyl acetate. Ethyl cyclohexanepropionate. Guaiacyl phenylacetate. Ethyl decanoate. Guaiene; 1,4-dimethyl-7-isopropenyl-∆9,10- 2-Ethylfuran. octahydroazulene. Ethyl 2-furanpropionate. Guaiol acetate; 1,4-dimethyl-7-(α-hydroxy- 4-Ethylguaiacol; 4-ethyl-2-methoxyphenol. isopropyl)-δ9,10-octahydroazulene acetate. Ethyl heptanoate. γ-Heptalactone; 4-hydroxyheptanoic acid, γ- 2-Ethyl-2-heptenal; 2-ethyl-3-butylacrolein. lactone. Ethyl hexanoate. Heptanal; enanthaldehyde. Ethyl isobutyrate. Heptanal dimethyl acetal. Ethyl isovalerate. Heptanal 1,2-glyceryl acetal. Ethyl lactate. 2,3-Heptanedione; acetyl valeryl. Ethyl laurate. 3-Heptanol. Ethyl levulinate. 2-Heptanone; methyl amyl ketone. Ethyl maltol; 2-ethyl-3-hydroxy-4H-pyran-4- 3-Heptanone; ethyl butyl ketone. one. 4-Heptanone; dipropyl ketone.
54
VerDate 06
cis-4-Heptenal; cis-4-hepten-1-al. Isoamyl 2-furanpropionate; α-isoamyl fur- Heptyl acetate. furylacetate. Heptyl alcohol; enanthic alcohol. Isoamyl hexanoate. Heptyl butyrate. Isoamyl isobutyrate. Heptyl cinnamate. Isoamyl isovalerate. Heptyl formate. Isoamyl laurate. Heptyl isobutyrate. Isoamyl-2-methylbutyrate; isopentyl-2- Heptyl octanoate. methylbutyrate. 1-Hexadecanol; cetyl alcohol. Isoamyl nonanoate. ω-6-Hexadecenlactone; 16-hydroxy-6- Isoamyl octanoate. hexadecenoic acid, ω-lactone; Isoamyl phenylacetate. ambrettolide. Isoamyl propionate. γ-Hexalactone; 4-hydroxyhexanoic acid, γ-lac- Isoamyl pyruvate. tone; tonkalide. Isoamyl salicylate. Hexanal; caproic aldehyde. Isoborneol. 2,3-Hexanedione; acetyl butyryl. Isobornyl acetate. Hexanoic acid; caproic acid. Isobornyl formate. 2-Hexenal. Isobornyl isovalerate. 2-Hexen-1-ol. Isobornyl propionate. 3-Hexen-1-ol; leaf alcohol. Isobutyl acetate. 2-Hexen-1-yl acetate. Isobutyl acetoacetate. Isobutyl alcohol. 3-Hexenyl isovalerate. Isobutyl angelate; isobutyl cis-2-methyl-2- 3-Hexenyl 2-methylbutyrate. butenoate. 3-Hexenyl phenylacetate; cis-3-hexenyl phen- Isobutyl anthranilate. ylacetate. Isobutyl benzoate. Hexyl acetate. Isobutyl butyrate. 2-Hexyl-4-acetoxytetrahydrofuran. Isobutyl cinnamate. Hexyl alcohol. Isobutyl formate. Hexyl butyrate. Isobutyl 2-furanpropionate. α -Hexylcinnamaldehyde. Isobutyl heptanoate. Hexyl formate. Isobutyl hexanoate. Hexyl hexanoate. Isobutyl isobutyrate. 2-Hexylidene cyclopentanone. α-Isobutylphenethyl alcohol; isobutyl benzyl Hexyl isovalerate. carbinol; 4-methyl-1-phenyl-2-pentanol. Hexyl 2-methylbutyrate. Isobutyl phenylacetate. Hexyl octanoate. Isobutyl propionate. Hexyl phenylacetate; n-hexyl phenylacetate. Isobutyl salicylate. Hexyl propionate. 2-Isobutylthiazole. Hydroxycitronellal; 3,7-dimethyl-7-hydroxy- Isobutyraldehyde. octanal. Isobutyric acid. Hydroxycitronellal diethyl acetal. Isoeugenol; 2-methoxy-4-propenylphenol. Hydroxycitronellal dimethyl acetal. Isoeugenyl acetate. Hydroxycitronellal; 3,7-dimethyl-1,7- Isoeugenyl benzyl ether; benzyl isoeugenol. octanediol. Isoeugenyl ethyl ether; 2-ethoxy-5-propenyl- N-(4-Hydroxy-3-methoxybenzyl)-nonanamide; anisole; ethyl isoeugenol. pelargonyl vanillylamide. Isoeugenyl formate. 5-Hydroxy-4-octanone; butyroin. Isoeugenyl methyl ether; 4-propenyl- 4-(p-Hydroxyphenyl)-2-butanone; p-hydroxy- veratrole; methyl isoeugenol. benzyl acetone. Isoeugenyl phenylacetate. Indole. Isojasmone; mixture of 2-hexylidenecyclo- α-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1- pentanone and 2-hexyl-2-cyclopenten-1-one. yl)-3-buten-2-one. α-Isomethylionone; 4-(2,6,6-trimethyl-2- β-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1- cyclohexen-1-yl)-3-methyl-3-buten-2-one; yl)-3-buten-2-one. methyl γ-ionone. α-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene- Isopropyl acetate. 1-yl)-3-buten-2-one; 6-methylionone. ρ-Isopropylacetophenone. Isoamyl acetate. Isopropyl alcohol; isopropanol. Isoamyl acetoacetate. Isopropyl benzoate. Isoamyl alcohol; isopentyl alcohol; 3-methyl- ρ-Isopropylbenzyl alcohol; cuminic alcohol; 1-butanol. ρ-cymen-7-ol. Isoamyl benzoate. Isopropyl butyrate. Isoamyl butyrate. Isopropyl cinnamate. Isoamyl cinnamate. Isopropyl formate. Isoamyl formate. Isopropyl hexanoate. Isoamyl 2-furanbutyrate; α-isoamyl furfuryl- Isopropyl isobutyrate. propionate. Isopropyl isovalerate.
55
VerDate 06
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. Isoquinoline. α-Methylbenzyl propionate; styralyl propio- Isovaleric acid. nate. cis-Jasmone; 3-methyl-2-(2-pentenyl)-2-cyclo- 2-Methyl-3-buten-2-ol. penten-1-one. 2-Methylbutyl isovalerate. Lauric aldehyde; dodecanal. Methyl p-tert-butylphenylacetate. Lauryl acetate. 2-Methylbutyraldehyde; methyl ethyl acetal- Lauryl alcohol; 1-dodecanol. dehyde. Lepidine; 4-methylquinoline. 3-Methylbutyraldehyde; isovaleraldehyde. Levulinic acid. Methyl butyrate. Linalool oxide; cis- and trans-2-vinyl-2-meth- 2-Methylbutyric acid. ′ ′ yl-5-(1 -hydroxy-1 -methylethyl) tetra- α-Methylcinnamaldehyde. hydrofuran. p-Methylcinnamaldehyde. Linalyl anthranilate; 3,7-dimethyl-1,6- Methyl cinnamate. octadien-3-yl anthranilate. 2-Methyl-1,3-cyclohexadiene. Linalyl benzoate. Methylcyclopentenolone; 3-methylcyclopen- Linalyl butyrate. tane-1,2-dione. Linalyl cinnamate. Methyl disulfide; dimethyl disulfide. Linalyl formate. Methyl ester of rosin, partially hydrogenated Linalyl hexanoate. Linalyl isobutyrate. (as defined in § 172.615); methyl Linalyl isovalerate. dihydroabietate. Linalyl octanoate. Methyl heptanoate. Linalyl propionate. 2-Methylheptanoic acid. Maltol; 3-hydroxy-2-methyl-4H-pyran-4-one. 6-Methyl-3,5-heptadien-2-one. Menthadienol; p-mentha-1,8(10)-dien-9-ol. Methyl-5-hepten-2-ol. p-Mentha-1,8-dien-7-ol; perillyl alcohol. 6-Methyl-5-hepten-2-one. Menthadienyl acetate; p-mentha-1,8(10)-dien- Methyl hexanoate. 9-yl acetate. Methyl 2-hexanoate. p-Menth-3-en-1-ol. Methyl p-hydroxybenzoate; methylparaben. 1-p-Menthen-–9-yl acetate; p-menth-1-en-9-yl Methyl α-ionone; 5-(2,6,6-trimethyl-2-cyclo- acetate. hexen-1-yl)-4-penten-3-one. Menthol; 2-isopropyl-5-methylcyclohexanol. Methyl β-ionone; 5-(2,6,6-trimethyl-1-cyclo- Menthone; p-menthan-3-one. hexen-1-yl)-4-penten-3-one. Menthyl acetate; p-menth-3-yl acetate. Methyl ∆-ionone; 5-(2,6,6-trimethyl-3-cyclo- Menthyl isovalerate; p-menth-3-yl iso- hexen-1-yl-)-4-penten-3-one. valerate. Methyl isobutyrate. o-Methoxybenzaldehyde. 2-Methyl-3-(p-isopropylphenyl)-propionalde- p-Methoxybenzaldehyde; p-anisaldehyde. hyde; α-methyl-p-isopropylhydro- o-Methoxycinnamaldehyde. cinnamal- dehyde; cyclamen aldehyde. 2-Methoxy-4-methylphenol; 4-methyl- Methyl isovalerate. guaiacol; 2-methoxy-p-cresol. Methyl laurate. 4-(p-Methoxyphenyl)-2-butanone; anisyl ace- Methyl mercaptan; methanethiol. tone. Methyl o-methoxybenzoate. 1-(4-Methoxyphenyl)-4-methyl-1-penten-3- Methyl N-methylanthranilate; dimethyl an- one; methoxystyryl isopropyl ketone. thranilate. 1-(p-Methoxyphenyl)-1-penten-3-one; α- Methyl 2-methylbutyrate. methylanisylidene acetone; ethone. Methyl-3-methylthiopropionate. 1-(p-Methoxyphenyl)-2-propanone; Methyl 4-methylvalerate. anisylmethyl ketone; anisic ketone. Methyl myristate. 2-Methoxy-4-vinylphenol; p-vinylguaiacol. Methyl β-naphthyl ketone; 2′-acetonaph- Methyl acetate. thone. 4′-Methylacetophenone; p-methylaceto- Methyl nonanoate. phenone; methyl p-tolyl ketone. Methyl 2-nonenoate. 2-Methylallyl butyrate; 2-methyl-2-propenl- Methyl 2-nonynoate; methyloctyne car- yl butyrate. bonate. Methyl anisate. 2-Methyloctanal; methyl hexyl acetaldehyde. o-Methylanisole; o-cresyl methyl ether. Methyl octanoate.
56
VerDate 06
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. 2-Methyl-4-phenyl-2-butyl acetate; dimethyl- Octyl acetate. phenylethyl carbinyl acetate. 3-Octyl acetate. 2-Methyl-4-phenyl-2-butyl isobutyrate; Octyl butyrate. dimethylphenyl ethylcarbinyl isobutyrate. Octyl formate. 3-Methyl-2-phenylbutyraldehyde; α-isopropyl Octyl heptanoate. phenylacetaldehyde. Octyl isobutyrate. Methyl 4-phenylbutyrate. Octyl isovalerate. 4-Methyl-1-phenyl-2-pentanone; benzyl iso- Octyl octanoate. butyl ketone. Octyl phenylacetate. Methyl 3-phenylpropionate; methyl hydro- Octyl propionate. cinnamate. ω-Pentadecalactone; 15-hydroxypentadeca- Methyl propionate. noic acid, ω-lactone; pentadecanolide; an- 3-Methyl-5-propyl-2-cyclohexen-1-one. gelica lactone. Methyl sulfide. 2,3-Pentanedione; acetyl propionyl. 3-Methylthiopropionaldehyde; methional. 2-Pentanone; methyl propyl ketone. 2-Methyl-3-tolylpropionaldehyde, mixed o-, 4-Pentenoic acid. m-, p-. 1-Penten-3-ol. 2-Methylundecanal; methyl nonyl acetal- Perillaldehyde; 4-isopropenyl-1-cyclohexene- dehyde. 1-carboxaldehyde;p-mentha-1,8-dien-7-al. Methyl 9-undecenoate. Perillyl acetate; p-mentha-1,8-dien-7-yl ace- Methyl 2-undecynoate; methyl decyne car- tate. bonate. α-Phellandrene; ρ-mentha-1,5-diene. Methyl valerate. Phenethyl acetate. 2-Methylvaleric acid. Phenethyl alcohol; β-phenylethyl alcohol. Myrcene; 7-methyl-3-methylene-1,6-octa- Phenethyl anthranilate. diene. Phenethyl benzoate. Myristaldehyde; tetradecanal. Phenethyl butyrate. d-Neomenthol; 2-isopropyl-5-methylcyclo- Phenethyl cinnamate. hexanol. Phenethyl formate. Nerol; cis-3,7-dimethyl-2,6-octadien-1-ol. Phenethyl isobutyrate. Nerolidol; 3,7,11-trimethyl-1,6,10-dodecatrien- Phenethyl isovalerate. 3-ol. Phenethyl 2-methylbutyrate. Neryl acetate. Phenethyl phenylacetate. Neryl butyrate. Phenethyl propionate. Neryl formate. Phenethyl salicylate. Neryl isobutyrate. Phenethyl senecioate; phenethyl 3,3-di- Neryl isovalerate. methylacrylate. Neryl propionate. Phenethyl tiglate. 2,6-Nonadien-1-ol. Phenoxyacetic acid. γ-Nonalactone; 4-hydroxynonanoic acid, γ- 2-Phenoxyethyl isobutyrate. lactone; aldehyde C–18. Phenylacetaldehyde; α-toluic aldehyde. Nonanal; pelargonic aldehyde. Phenylacetaldehyde 2,3-butylene glycol ace- 1,3-Nonanediol acetate, mixed esters. tal. Nonanoic acid; pelargonic acid. Phenylacetaldehyde dimethyl acetal. 2-Nonanone; methylheptyl ketone. Phenylacetaldehyde glyceryl acetal. 3-Nonanon-1-yl acetate; 1-hydroxy-3- Phenylacetic acid; α-toluic acid. nonanone acetate. 4-Phenyl-2-butanol; phenylethyl methyl car- Nonyl acetate. binol. Nonyl alcohol; 1-nonanol. 4-Phenyl-3-buten-2-ol; methyl styryl car- Nonyl octanoate. binol. Nonyl isovalerate. 4-Phenyl-3-buten-2-one. Nootkatone; 5,6-dimethyl-8-isopropenyl- 4-Phenyl-2-butyl acetate; phenylethyl meth- bicyclo[4,4,0]-dec-1-en-3-one. yl carbinyl acetate. Ocimene; trans-β-ocimene; 3,7-dimethyl-1,3,6- 1-Phenyl-3-methyl-3-pentanol; phenylethyl octatriene. methyl ethyl carbinol. γ-Octalactone; 4-hydroxyoctanoic acid, γ-lac- 1-Phenyl-1-propanol; phenylethyl carbinol. tone. 3-Phenyl-1-propanol; hydrocinnamyl alcohol.
57
VerDate 06
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. 3-Phenylpropyl formate. Skatole. 3-Phenylpropyl hexanoate. Sorbitan monostearate. 2-Phenylpropyl isobutyrate. Styrene. 3-Phenylpropyl isobutyrate. Sucrose octaacetate. 3-Phenylpropyl isovalerate. α-Terpinene. 3-Phenylpropyl propionate. γ-Terpinene. 2-(3-Phenylpropyl)-tetrahydrofuran. α-Terpineol; p-menth-1-en-8-ol. α-Pinene; 2-pinene. β-Terpineol. β-Pinene; 2(10)-pinene. Terpinolene; p-menth-1,4(8)-diene. Pine tar oil. Terpinyl acetate. Pinocarveol; 2(10)-pinen-3-ol. Terpinyl anthranilate. Piperidine. Terpinyl butyrate. Piperine. Terpinyl cinnamate. d-Piperitone; p-menth-1-en-3-one. Terpinyl formate. Piperitenone; p-mentha-1,4(8)-dien-3-one. Terpinyl isobutyrate. Piperitenone oxide; 1,2-epoxy-p-menth-4-(8)- Terpinyl isovalerate. en-3-one. Terpinyl propionate. Piperonyl acetate; heliotropyl acetate. Tetrahydrofurfuryl acetate. Piperonyl isobutyrate. Tetrahydrofurfuryl alcohol. Polylimonene. Tetrahydrofurfuryl butyrate. Polysorbate 20; polyoxyethylene (20) sorbitan Tetrahydrofurfuryl propionate. monolaurate. Tetrahydro-pseudo-ionone; 6,10-dimethyl-9- Polysorbate 60; polyoxyethylene (20) sorbitan undecen-2-one. monostereate. Tetrahydrolinalool; 3,7-dimethyloctan-3-ol. Polysorbate 80; polyoxyethylene (20) sorbitan Tetramethyl ethylcyclohexenone; mixture of monooleate. 5-ethyl-2,3,4,5-tetramethyl-2-cyclohexen-1- Potassium acetate. one and 5-ethyl-3,4,5,6-tetramethyl-2-cyclo- Propenylguaethol; 6-ethoxy-m-anol. hexen-1-one. Propionaldehyde. 2-Thienyl mercaptan; 2-thienylthiol. Propyl acetate. Thymol. Propyl alcohol; 1-propanol. Tolualdehyde glyceryl acetal, mixed o, m, p. p-Propyl anisole; dihydroanethole. Tolualdehydes, mixed o, m, p. Propyl benzoate. p-Tolylacetaldehyde. Propyl butyrate. o-Tolyl acetate; o-cresyl acetate. Propyl cinnamate. p-Tolyl acetate; p-cresyl acetate. Propyl disulfide. 4-(p-Tolyl)-2-butanone; p-methylbenzylace- Propyl formate. tone. Propyl 2-furanacrylate. p-Tolyl isobutyrate. Propyl heptanoate. p-Tolyl laurate. Propyl hexanoate. p-Tolyl phenylacetate. Propyl p-hydroxybenzoate; propylparaben. 2-(p-Tolyl)-propionaldehyde; p-methylhydra- 3-Propylidenephthalide. tropic aldehyde. Propyl isobutyrate. Tributyl acetylcitrate. Propyl isovalerate. 2-Tridecenal. Propyl mercaptan. 2,3-Undecadione; acetyl nonyryl. α-Propylphenethyl alcohol. γ-Undecalactone; 4-hydroxyundecanoic acid Propyl phenylacetate. γ-lactone; peach aldehyde; aldehyde C–14. Propyl propionate. Undecenal. Pulegone; p-menth-4(8)-en-3-one. 2-Undecanone; methyl nonyl ketone. Pyridine. 9-Undecenal; undecenoic aldehyde. Pyroligneous acid extract. 10-Undecenal. Pyruvaldehyde. Undecen-1-ol; undecylenic alcohol. Pyruvic acid. 10-Undecen-1-yl acetate. Rhodinol; 3,7-dimethyl-7-octen-1-ol; l- Undecyl alcohol. citronellol. Valeraldehyde; pentanal. Rhodinyl acetate. Valeric acid; pentanoic acid. Rhodinyl butyrate. Vanillin acetate; acetyl vanillin.
58
VerDate 06
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 spectively, in accordance with § 166.110 pickling spice that is added to the of this chapter. pickling brine. (d) BHA (butylated hydroxyanisole) [56 FR 6968, Feb. 21, 1991] may be used as an antioxidant in fla- voring substances whereby the additive § 172.560 Modified hop extract. does not exceed 0.5 percent of the es- The food additive modified hop ex- sential (volatile) oil content of the fla- tract may be safely used in beer in ac- voring substance. cordance with the following prescribed [42 FR 14491, Mar. 15, 1977, as amended at 42 conditions: FR 23148, May 6, 1977; 43 FR 19843, May 9, (a) The food additive is used or in- 1978; 45 FR 22915, Apr. 4, 1980; 47 FR 27810, tended for use as a flavoring agent in June 25, 1982; 48 FR 10812, Mar. 15, 1983; 48 FR the brewing of beer. 51907, Nov. 15, 1983; 49 FR 5747, Feb. 15, 1984; (b) The food additive is manufactured 50 FR 42932, Oct. 23, 1985; 54 FR 7402, Feb. 21, 1989; 61 FR 14245, Apr. 1, 1996] by one of the following processes: (1) The additive is manufactured § 172.520 Cocoa with dioctyl sodium from a hexane extract of hops by si- sulfosuccinate for manufacturing. multaneous isomerization and selec- tive reduction in an alkaline aqueous The food additive ‘‘cocoa with dioctyl medium with sodium borohydride, sodium sulfosuccinate for manufac- whereby the additive meets the fol- turing,’’ conforming to § 163.117 of this lowing specifications: chapter and § 172.810, is used or in- tended for use as a flavoring substance (i) A solution of the food additive sol- in dry beverage mixes whereby the ids is made up in approximately 0.012 n amount of dioctyl sodium sulfo- alkaline methyl alcohol (6 milliliters succinate does not exceed 75 parts per of 1 n sodium hydroxide diluted to 500 million of the finished beverage. The milliliters with methyl alcohol) to labeling of the dry beverage mix shall show an absorbance at 253 millimicrons bear adequate directions to assure use of 0.6 to 0.9 per centimeter. (This ab- in compliance with this section. sorbance is obtained by approximately 0.03 milligram solids permilliliter.) The § 172.530 Disodium guanylate. ultraviolet absorption spectrum of this solution exhibits the following charac- Disodium guanylate may be safely teristics: An absorption peak at 253 used as a flavor enhancer in foods, at a millimicrons; no absorption peak at 325 level not in excess of that reasonably to 330 millimicrons; the absorbance at required to produce the intended effect. 268 millimicrons does not exceed the absorbance at 272 millimicrons. § 172.535 Disodium inosinate. (ii) The boron content of the food ad- The food additive disodium inosinate ditive does not exceed 310 parts per may be safely used in food in accord- million (0.0310 percent), calculated as ance with the following prescribed con- boron. ditions: (2) The additive is manufactured (a) The food additive is the disodium from hops by a sequence of extractions salt of inosinic acid, manufactured and and fractionations, using benzene, light purified so as to contain no more than petroleum spirits, and methyl alcohol 150 parts per million of soluble barium as solvents, followed by isomerization in the compound disodium inosinate by potassium carbonate treatment. with seven and one-half molecules of Residues of solvents in the modified water of crystallization. hop extract shall not exceed 1.0 part
59
VerDate 06
per million of benzene, 1.0 part per mil- (6) The additive is manufactured lion of light petroleum spirits, and 250 from hops by an initial extraction and parts per million of methyl alcohol. fractionation using one or more of the The light petroleum spirits and ben- solvents listed in paragraph (b)(5) of zene solvents shall comply with the this section followed by: Hydro- specifications in § 172.250 except that genation using palladium as a catalyst the boiling point range for light petro- in methyl alcohol, ethyl alcohol, or ° ° leum spirits is 150 F–300 F. isopropyl alcohol acidified with hydro- (3) The additive is manufactured chloric or sulfuric acid; oxidation with from hops by a sequence of extractions peracetic acid; isomerization by cal- and fractionations, using methylene chloride, hexane, and methyl alcohol as cium chloride or magnesium chloride solvents, followed by isomerization by treatment in ethylene dichloride, sodium hydroxide treatment. Residues methylene chloride, or trichloro- of the solvents in the modified hop ex- ethylene (alternatively, the hydro- tract shall not exceed 5 parts per mil- genation and isomerization steps may lion of methylene chloride, 25 parts per be performed in reverse order); and a million of hexane, and 100 parts per further sequence of extractions and million of methyl alcohol. fractionations using one or more of the (4) The additive is manufactured solvents listed in paragraph (b)(5) of from hops by a sequence of extractions this section. The additive shall meet and fractionations, using benzene, light the residue limitations as prescribed in petroleum spirits, methyl alcohol, n- paragraph (b)(5) of this section. butyl alcohol, and ethyl acetate as sol- (7) The additive is manufactured vents, followed by isomerization by po- from hops as set forth in paragraph tassium carbonate treatment. Residues (b)(6) of this section followed by reduc- of solvents in the modified hop extract tion with sodium borohydride in aque- shall not exceed 1.0 part per million of ous alkaline methyl alcohol, and a se- benzene, 1.0 part per million of light petroleum spirits, 50 parts per million quence of extractions and fraction- of methyl alcohol, 50 parts per million ations using one or more of the sol- of n-butyl alcohol, and 1 part per mil- vents listed in paragraph (b)(5) of this lion of ethyl acetate. The light petro- section. The additive shall meet the leum spirits and benzene solvents shall residue limitations as prescribed in comply with the specifications in paragraph (b)(5) of this section, and a § 172.250 except that the boiling point boron content level not in excess of 300 range for light petroleum spirits is 150 parts per million (0.0300 percent), cal- °F to 300 °F. culated as boron. (5) The additive is manufactured (8) The additive is manufactured from hops by an initial extraction and from hops as a nonisomerizable non- fractionation using one or more of the volatile hop resin by an initial extrac- following solvents: Ethylene dichlo- tion and fractionation using one or ride, hexane, isopropyl alcohol, methyl more of the solvents listed in para- alcohol, methylene chloride, trichloro- graph (b)(5) of this section followed by ethylene, and water; followed by a sequence of aqueous extractions and isomerization by calcium chloride or removal of nonaqueous solvents to less magnesium chloride treatment in ethylene dichloride, methylene chlo- than 0.5 percent. The additive is added ride, or trichloroethylene and a further to the wort before or during cooking in sequence of extractions and fraction- the manufacture of beer. ations using one or more of the sol- vents set forth in this paragraph. Resi- § 172.575 Quinine. dues of the solvents in the modified Quinine, as the hydrochloride salt or hop extract shall not exceed 125 parts sulfate salt, may be safely used in food per million of hexane; 150 parts per mil- in accordance with the following condi- lion of ethylene dichloride, methylene tions: chloride, or trichloroethylene; or 250 parts per million of isopropyl alcohol or methyl alcohol.
60
VerDate 06
Uses Limitations used in food in accordance with the fol- lowing prescribed conditions: In carbonated bev- Not to exceed 83 parts per million, as (a) The additive is produced by par- erages as a flavor. quinine. Label shall bear a promi- nent declaration of the presence of tial hydrolysis of yeast extract (de- quinine either by the use of the rived from Saccharomyces cereviseae, word ``quinine'' in the name of the Saccharomyces fragilis, or Candida utilis) article or through a separate dec- laration. using the sprout portion of malt barley as the source of enzymes. The additive contains a maximum of 6 percent 5′ nu- § 172.580 Safrole-free extract of sas- cleotides by weight. safras. (b) The additive may be used as a fla- The food additive safrole-free extract vor enhancer in food at a level not in of sassafras may be safely used in ac- excess of that reasonably required to cordance with the following prescribed produce the intended effect. conditions: (a) The additive is the aqueous ex- Subpart G—Gums, Chewing Gum tract obtained from the root bark of Bases and Related Substances the plant Sassafras albidum (Nuttall) Nees (Fam. Lauraceae). § 172.610 Arabinogalactan. (b) It is obtained by extracting the Arabinogalactan may be safely used bark with dilute alcohol, first concen- in food in accordance with the fol- trating the alcoholic solution by vacu- lowing conditions: um distillation, then diluting the con- (a) Arabinogalactan is a poly- centrate with water and discarding the saccharide extracted by water from oily fraction. Western larch wood, having galactose (c) The purified aqueous extract is units and arabinose units in the ap- safrole-free. proximate ratio of six to one. (d) It is used as a flavoring in food. (b) It is used in the following foods in the minimum quantity required to § 172.585 Sugar beet extract flavor base. produce its intended effect as an emul- sifier, stabilizer, binder, or bodying Sugar beet extract flavor base may agent: Essential oils, nonnutritive be safely used in food in accordance sweeteners, flavor bases, nonstandard- with the provisions of this section. ized dressings, and pudding mixes. (a) Sugar beet extract flavor base is the concentrated residue of soluble § 172.615 Chewing gum base. sugar beet extractives from which The food additive chewing gum base sugar and glutamic acid have been re- may be safely used in the manufacture covered, and which has been subjected of chewing gum in accordance with the to ion exchange to minimize the con- following prescribed conditions: centration of naturally occurring trace (a) The food additive consists of one minerals. or more of the following substances (b) It is used as a flavor in food. that meet the specifications and limi- tations prescribed in this paragraph, § 172.590 Yeast-malt sprout extract. used in amounts not to exceed those re- Yeast-malt sprout extract, as de- quired to produce the intended physical scribed in this section, may be safely or other technical effect.
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.
61
VerDate 06
MASTICATORY SUBSTANCESÐContinued NATURAL (COAGULATED OR CONCENTRATED LATICES) OF VEGETABLE ORIGIN
Family Genus and species
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.
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.
62
VerDate 06
MASTICATORY SUBSTANCESÐContinued NATURAL (COAGULATED OR CONCENTRATED LATICES) OF VEGETABLE ORIGIN
Family Genus and species
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- Chondrus ocellatus. ed in paragraph (a) of this section, Eucheuma cottonii. chewing gum base may also include Eucheuma spinosum. Gigartina acicularis. substances generally recognized as safe Gigartina pistillata. in food. Gigartina radula. (c) To assure safe use of the additive, Gigartina stellata. in addition to the other information re- (b) The food additive conforms to the quired by the act, the label and label- following conditions: ing of the food additive shall bear the (1) It is a sulfated polysaccharide the name of the additive, ‘‘chewing gum dominant hexose units of which are ga- base.’’ As used in this paragraph, the lactose and anhydrogalactose. term ‘‘chewing gum base’’ means the (2) Range of sulfate content: 20 per- manufactured or partially manufac- cent to 40 percent on a dry-weight tured nonnutritive masticatory sub- basis. stance comprised of one or more of the (c) The food additive is used or in- ingredients named and so defined in tended for use in the amount necessary paragraph (a) of this section. for an emulsifier, stabilizer, or thick- [42 FR 14491, Mar. 15, 1977, as amended at 45 ener in foods, except for those stand- FR 56051, Aug. 22, 1980; 49 FR 5747, Feb. 15, ardized foods that do not provide for 1984; 49 FR 10105, Mar. 19, 1984] such use. (d) To assure safe use of the additive, § 172.620 Carrageenan. the label and labeling of the additive The food additive carrageenan may shall bear the name of the additive, be safely used in food in accordance carrageenan. with the following prescribed condi- § 172.623 Carrageenan with poly- tions: sorbate 80. (a) The food additive is the refined hydrocolloid prepared by aqueous ex- Carrageenan otherwise meeting the traction from the following members of definition and specifications of § 172.620 (a) and (b) and salts of carrageenan the families Gigartinaceae and Solier- otherwise meeting the definition of iaceae of the class Rodophyceae (red § 172.626(a) may be safely produced with seaweed): the use of polysorbate 80 meeting the Chondrus crispus. specifications and requirements of
63
VerDate 06
§ 172.840 (a) and (b) in accordance with dium carrageenan’’, ‘‘potassium carra- the following prescribed conditions: geenan’’, etc. (a) The polysorbate 80 is used only to facilitate separation of sheeted carra- § 172.655 Furcelleran. geenan and salts of carrageenan from The food additive furcelleran may be drying rolls. safely used in food in accordance with (b) The carrageenan and salts of car- the following prescribed conditions: rageenan contain not more than 5 per- (a) The food additive is the refined cent by weight of polysorbate 80, and hydrocolloid prepared by aqueous ex- the final food containing the additives traction of furcellaria fastigiata of the contains polysorbate 80 in an amount class Rodophyceae (red seaweed). not to exceed 500 parts per million. (b) The food additive conforms to the (c) The carrageenan and salts of car- following: rageenan so produced are used only in producing foods in gel form and only (1) It is a sulfated polysaccharide the for the purposes defined in §§ 172.620(c) dominant hexose units of which are ga- and 172.626(b), respectively. lactose and anhydrogalactose. (d) The carrageenan and salts of car- (2) Range of sulfate content: 8 per- rageenan so produced are not used in cent to 19 percent, on a dry-weight foods for which standards of identity basis. exist unless the standards provide for (c) The food additive is used or in- the use of carrageenan, or salts of car- tended for use in the amount necessary rageenan, combined with polysorbate for an emulsifier, stabilizer, or thick- 80. ener in foods, except for those stand- (e) The carrageenan and salts of car- ardized foods that do not provide for rageenan produced in accordance with such use. this section, and foods containing the (d) To assure safe use of the additive, same, in addition to the other require- the label and labeling of the additive ments of the Act, are labeled to show shall bear the name of the additive, the presence of polysorbate 80, and the furcelleran. label or labeling of the carrageenan and salts of carrageenan so produced § 172.660 Salts of furcelleran. bear adequate directions for use. The food additive salts of furcelleran § 172.626 Salts of carrageenan. may be safely used in food in accord- ance with the following prescribed con- The food additive salts of carra- ditions: geenan may be safely used in food in (a) The food additive consists of fur- accordance with the following pre- celleran, meeting the provisions of scribed conditions: § 172.655, modified by increasing the (a) The food additive consists of car- concentration of one of the naturally rageenan, meeting the provisions of occurring salts (ammonium, calcium, § 172.620, modified by increasing the concentration of one of the naturally potassium, or sodium) of furcelleran to occurring salts (ammonium, calcium, the level that it is the dominant salt in potassium, or sodium) of carrageenan the additive. to the level that it is the dominant salt (b) The food additive is used or in- in the additive. tended for use in the amount necessary (b) The food additive is used or in- for an emulsifier, stabilizer, or thick- tended for use in the amount necessary ener in foods, except for those stand- for an emulsifier, stabilizer, or thick- ardized foods that do not provide for ener in foods, except for those stand- such use. ardized foods that do not provide for (c) To assure safe use of the additive, such use. the label and labeling of the additive (c) To assure safe use of the additive, shall bear the name of the salt of fur- the label and labeling of the additive celleran that dominates the mixture by shall bear the name of the salt of car- reason of the modification, e.g., ‘‘so- rageenan that dominates the mixture dium furcelleran’’, ‘‘potassium furcel- by reason of the modification, e.g., ‘‘so- leran’’, etc.
64
VerDate 06
§ 172.665 Gellan gum. 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, (c) The additive is produced by a and Cosmetic Act, the name of the ad- process that renders it free of viable ditive and the designation ‘‘food cells of P. elodea. grade’’. (d) The additive meets the following (2) The label or labeling of the food specifications: additive container shall bear adequate (1) Positive for gellan gum when sub- directions for use. jected to the following identification tests: [55 FR 39614, Sept. 28, 1990, as amended at 57 (i) A 1-percent solution is made by FR 55445, Nov. 25, 1992; 64 FR 1758, Jan. 12, 1999] hydrating 1 gram of gellan gum in 99 milliliters of distilled water. The mix- § 172.695 Xanthan gum. ture is stirred for about 2 hours, using a motorized stirrer and a propeller- The food additive xanthan gum may type stirring blade. A small amount of be safely used in food in accordance the above solution is drawn into a wide with the following prescribed condi- bore pipet and transferred into a solu- tions: tion of 10-percent calcium chloride. A (a) The additive is a polysaccharide tough worm-like gel will form in- gum derived from Xanthomonas stantly. campestris by a pure-culture fermenta- (ii) To the 1-percent distilled water tion process and purified by recovery solution prepared for identification with isopropyl alcohol. It contains D- test (i), 0.50 gram of sodium chloride is glucose, D-mannose, and D-glucuronic added. The solution is heated to 80 °C acid as the dominant hexose units and with stirring, held at 80 °C for 1 is manufactured as the sodium, potas- minute, and allowed to cool to room sium, or calcium salt. temperature without stirring. A firm (b) The strain of Xanthomonas gel will form. campestris is nonpathogenic and (2) Residual isopropyl alcohol (IPA) nontoxic in man or other animals. not to exceed 0.075 percent as deter- (c) The additive is produced by a mined by the procedure described in process that renders it free of viable the Xanthan Gum monograph, the cells of Xanthomonas campestris. ‘‘Food Chemicals Codex,’’ 4th ed. (1996), (d) The additive meets the following pp. 437–438, which is incorporated by specifications: reference in accordance with 5 U.S.C. (1) Residual isopropyl alcohol not to 552(a) and 1 CFR part 51. Copies are exceed 750 parts per million. available from the National Academy (2) An aqueous solution containing 1 Press, Box 285, 2101 Constitution Ave. percent of the additive and 1 percent of NW., Washington, DC 20055 (Internet potassium chloride stirred for 2 hours
65
VerDate 06
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 Set the beaker and its contents aside to contains less than 1.5 percent of pyruvic acid cool in the absence of agitation. Allow a by weight. minimum time of 2 hours for cooling. Exam- (e) The additive is used or intended ine the cooled beaker contents for a firm for use in accordance with good manu- rubbery gel formation after the temperature drops below 40 °C. facturing practice as a stabilizer, emul- In the event that a gel is obtained, make sifier, thickener, suspending agent, up a 1 percent solution of the polysaccharide bodying agent, or foam enhancer in to be tested in 200 milliliters of distilled foods for which standards of identity water previously heated to 80 °C (omit the lo- established under section 401 of the Act cust bean gum). Allow the solution to cool do not preclude such use. without agitation as before. Formation of a (f) To assure safe use of the additive: gel on cooling indicates that the sample is a (1) The label of its container shall gelling polysaccharide and not xanthan gum. bear, in addition to other information Record the sample as ‘‘positive’’ for xan- than gum if a firm, rubbery gel forms in the required by the Act, the name of the presence of locust bean gum but not in its additive and the designation ‘‘food absence. Record the sample as ‘‘negative’’ for grade’’. xanthan gum if no gel forms or if a soft or (2) The label or labeling of the food brittle gel forms both with locust bean gum additive container shall bear adequate and in a 1 percent solution of the sample directions for use. (containing no locust bean gum). (4) Positive for xanthan gum when Subpart H—Other Specific Usage subjected to the following procedure: Additives
PYRUVIC ACID TEST § 172.710 Adjuvants for pesticide use dilutions. Pipet 10 milliliters of an 0.6 percent solu- tion of the polysaccharide in distilled water The following surfactants and related (60 milligrams of water-soluble gum) into a adjuvants may be safely added to pes- 50-milliliter flask equipped with a standard ticide use dilutions by a grower or ap- taper glass joint. Pipet in 20 milliliters of 1N plicant prior to application to the hydrochloric acid. Weigh the flask. Reflux growing crop: the mixture for 3 hours. Take precautions to avoid loss of vapor during the refluxing. Cool n-Alkyl (C8-C18) amine acetate, where the the solution to room temperature. Add dis- alkyl groups (C8-C18) are derived from coco- tilled water to make up any weight loss from nut oil, as a surfactant in emulsifier blends the flask contents. at levels not in excess of 5 percent by weight Pipet 1 milliliter of a 2,4-dinitrophenyl- of the emulsifier blends that are added to hydrazine reagent (0.5 percent in 2N hydro- herbicides for application to corn and sor- chloric acid) into a 30-milliliter separatory ghum.
66
VerDate 06
Di-n-alkyl (C8-C18) dimethyl ammonium ene Glycol’’ in the Food Chemicals chloride, where the alkyl groups (C8-C18) are Codex, 4th ed. (1996), p. 52, which is in- derived from coconut oil, as surfactants in corporated by reference in accordance emulsifier blends at levels not in excess of 5 with 5 U.S.C. 552(a) and 1 CFR part 51. percent by weight of emulsifier blends that 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 Safety and Applied Nutrition, 200 C St. mixture of saturated and unsaturated soy- SW., Washington, DC 20204–0001, or may bean oil fatty acids (C16-C18) as a surfactant be examined at the Center for Food in emulsifier blends that are added to the Safety and Applied Nutrition’s Li- herbicide atrazine for application to corn. brary, Food and Drug Administration, Diethanolamide condensate based on 200 C St. SW., rm. 3321, Washington, stripped coconut fatty acids (C10 C18) as a 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. 700, Washington, DC. α-(p-Dodecylphenyl)-omega-hydroxypoly (c) It is used in the manufacture of (oxyethylene) produced by the condensation sausage casings as a formulation aid as of 1 mole of dodecylphenol (dodecyl group is defined in § 170.3(o)(14) of this chapter a proplyene tetramer isomer) with an aver- and as a processing aid as defined in age of 4–14 or 30–70 moles of ethylene oxide; if a blend of products is used, the average § 170.3(o)(24) of this chapter. number of moles of ethylene oxide reacted to [62 FR 26228, May 13, 1997] produce any product that is a component of the blend shall be in the range of 4–14 or 30– § 172.715 Calcium lignosulfonate. 70. Ethylene dichloride. Calcium lignosulfonate may be safely Polyglyceryl phthalate ester of coconut oil used in or on food, subject to the provi- fatty acids. sions of this section. α-[p-(1,1,3,3-Tetramethylbutyl) phenyl]- (a) Calcium lignosulfonate consists of omega-hydroxypoly(oxyethylene) produced sulfonated lignin, primarily as calcium by the condensation of 1 mole of p-(1,1,3,3- and sodium salts. tetramethylbutyl) phenol with an average of 4–14 or 30–70 moles of ethylene oxide; if a (b) It is used in an amount not to ex- blend of products is used, the average num- ceed that reasonably required to ac- ber of moles of ethylene oxide reacted to complish the intended physical or tech- produce any product that is a component of nical effect when added as a dispersing the blend shall be in the range of 4–14 or 30– agent and stabilizer in pesticides for 70. preharvest or postharvest application α -[p-(1,1,3,3-Tetramethylbutyl) phenyl]- to bananas. omega-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-(1,1,3,3- § 172.720 Calcium lactobionate. tetramethylbutyl) phenol with 1 mole of ethylene oxide. The food additive calcium Sodium acrylate and acrylamide copoly- lactobionate may be safely used in food mer with a minimum average molecular in accordance with the following pre- weight of 10,000,000 in which 30 percent of the scribed conditions: polymer is comprised of acrylate units and 70 (a) The food additive is the calcium percent acrylamide units, for use as a drift β control agent in herbicide formulations ap- salt of lactobionic acid (4-( ,D- plied to crops at a level not to exceed 0.5 galactosido)-D-gluconic acid) produced ounces of the additive per acre. by the oxidation of lactose. (b) It is used or intended for use as a § 172.712 1,3-Butylene glycol. firming agent in dry pudding mixes at The food additive 1,3-butylene glycol a level not greater than that required (CAS Reg. No. 107–88–0) may be safely to accomplish the intended effect. used in food in accordance with the fol- lowing prescribed conditions: § 172.723 Epoxidized soybean oil. (a) It is prepared by the aldol con- Epoxidized soybean oil may be safely densation of acetaldehyde followed by used in accordance with the following catalytic hydrogenation. prescribed conditions: (b) The food additive shall conform (a) The additive is prepared by react- to the identity and specifications listed ing soybean oil in toluene with hydro- in the monograph entitled ‘‘1,3-Butyl- gen peroxide and formic acid.
67
VerDate 06
(b) It meets the following specifica- § 172.725 Gibberellic acid and its po- tions: tassium salt. (1) Epoxidized soybean oil contains The food additives gibberellic acid oxirane oxygen, between 7.0 and 8.0 per- and its potassium salt may be used in cent, as determined by the American the malting of barley in accordance Oil Chemists’ Society (A.O.C.S.) meth- with the following prescribed condi- od Cd 9–57, ‘‘Oxirane Oxygen,’’ re- tions: approved 1989, which is incorporated by (a) The additives meet the following reference in accordance with 5 U.S.C specifications: 552(a) and 1 CFR part 51. Copies are (1) The gibberellic acid is produced available from the American Oil Chem- by deep-culture fermentation of a suit- ists’ Society, P. O. Box 3489, Cham- able nutrient medium by a strain of paign, IL 61826–3489, or may be exam- Fusarium moniliforme or a selection of ined at the Division of Petition Control this culture. (HFS–215), Center for Food Safety and (2) The gibberellic acid produced is of Applied Nutrition, Food and Drug Ad- 80 percent purity or better. ministration, 1110 Vermont Ave. NW., (3) The empirical formula of suite 1200, Washington, DC, or at the gibberellic acid is represented by Office of the Federal Register, 800 C19H22O6. North Capitol St. NW., suite 700, Wash- (4) Potassium gibberellate is the po- ington, DC. tassium salt of the specified gibberellic (2) The maximum iodine value is 3.0, acid. as determined by A.O.C.S. method Cd (5) The potassium gibberellate is of 80 1–25, ‘‘Iodine Value of Fats and Oils percent purity or better. Wijs Method,’’ revised 1993, which is in- (6) The gibberellic acid or potassium gibberellate may be diluted with sub- corporated by reference in accordance stances generally recognized as safe in with 5 U.S.C. 552(a) and 1 CFR part 51. foods or with salts of fatty acids con- The availability of this incorporation forming to § 172.863. by reference is given in paragraph (b) They are used or intended for use (b)(1) of this section. in the malting of barley under condi- (3) The heavy metals (as Pb) content tions whereby the amount of either or cannot be more than 10 parts per mil- both additives present in the malt is lion, as determined by the ‘‘Heavy Met- not in excess of 2 parts per million ex- als Test,’’ of the ‘‘Food Chemicals pressed as gibberellic acid, and the Codex,’’ 4th ed. (1996), pp. 760–761, Meth- treated malt is to be used in the pro- od II (with a 2-gram sample and 20 duction of fermented malt beverages or microgram of lead ion in the control), distilled spirits only, whereby the fin- which is incorporated by reference in ished distilled spirits contain none and accordance with 5 U.S.C. 552(a) and 1 the finished malt beverage contains CFR part 51. Copies are available from not more than 0.5 part per million of the National Academy Press, Box 285, gibberellic acid. 2101 Constitution Ave. NW., Wash- (c) To insure the safe use of the food ington, DC 20055 (Internet address additives the label of the package shall ‘‘http://www.nap.edu’’), or may be ex- bear, in addition to the other informa- amined at the Center for Food Safety tion required by the Act: and Applied Nutrition’s Library, Food (1) The name of the additive, and Drug Administration, 200 C St. ‘‘gibberellic acid’’ or ‘‘potassium SW., rm. 3321, Washington, DC, or at gibberellate’’, whichever is appro- the Office of the Federal Register, 800 priate. North Capitol St. NW., suite 700, Wash- (2) An accurate statement of the con- ington, DC. centration of the additive contained in the package. (c) The additive is used as a halogen (3) Adequate use directions to provide stabilizer in brominated soybean oil at not more than 2 parts per million of a level not to exceed 1 percent. gibberellic acid in the finished malt. [60 FR 32903, June 26, 1995, as amended at 64 (4) Adequate labeling directions to FR 1759, Jan. 12, 1999] provide that the final malt is properly
68
VerDate 06
labeled as described in paragraph (d) of beverages only’’, or ‘‘Distiller’s Malt— this section. To be used in the production of dis- (d) To insure the safe use of the addi- tilled spirits only’’, whichever is the tive the label of the treated malt shall case. bear, in addition to the other informa- tion required by the Act, the state- § 172.735 Glycerol ester of wood rosin. ments: Glycerol ester of wood rosin may be (1) ‘‘Contains not more than 2 parts safely used in food in accordance with per million lll’’, the blank being the following prescribed conditions: filled in with the words ‘‘gibberellic acid’’ or ‘‘potassium gibberellate’’, (a) It has an acid number of 3 to 9, a ° ° whichever is appropriate; and drop-softening point of 88 C–96 C; and (2) ‘‘Brewer’s malt—To be used in the a color of N or paler as determined in production of fermented malt bev- accordance with Official Naval Stores erages only’’ or ‘‘Distiller’s malt—To Standards of the United States. It is be used in the production of distilled purified by countercurrent steam dis- spirits only’’, whichever is appropriate. tillation. (b) It is used to adjust the density of § 172.730 Potassium bromate. citrus oils used in the preparation of The food additive potassium bromate beverages whereby the amount of the may be safely used in the malting of additive does not exceed 100 parts per barley under the following prescribed million of the finished beverage. conditions: (a)(1) It is used or intended for use in § 172.755 Stearyl monoglyceridyl cit- the malting of barley under conditions rate. whereby the amount of the additive The food additive stearyl present in the malt from the treatment monoglyceridyl citrate may be safely does not exceed 75 parts per million of used in food in accordance with the fol- bromate (calculated as Br), and the lowing provisions: treated malt is used only in the pro- (a) The additive is prepared by con- duction of fermented malt beverages or distilled spirits. trolled chemical reaction of the fol- (2) The total residue of inorganic bro- lowing: mides in fermented malt beverages, re- Reactant Limitations sulting from the use of the treated malt plus additional residues of inor- Citric acid ...... ganic bromides that may be present Monoglycerides of fatty Prepared by the glycerolysis of ed- acids. ible fats and oils or derived from from uses in accordance with other reg- fatty acids conforming with ulations in this chapter promulgated § 172.860. under sections 408 and/or 409 of the act, Stearyl alcohol ...... Derived from fatty acids con- does not exceed 25 parts per million of forming with § 172.860, or de- rived synthetically in conformity bromide (calculated as Br). No toler- with § 172.864. ance is established for bromide in dis- tilled spirits because there is evidence (b) The additive stearyl that inorganic bromides do not pass monoglyceridyl citrate, produced as over in the distillation process. described under paragraph (a) of this (b) To assure safe use of the additive, section, meets the following specifica- the label or labeling of the food addi- tions: tive shall bear, in addition to the other information required by the Act, the Acid number 40 to 52. following: Total citric acid 15 to 18 percent. (1) The name of the additive. Saponification number 215–255. (2) Adequate directions for use. (c) The additive is used or intended (c) To assure safe use of the additive, for use as an emulsion stabilizer in or the label or labeling of the treated malt shall bear, in addition to other in- with shortenings containing emulsi- formation required by the Act, the fiers. statement, ‘‘Brewer’s Malt—To be used in the production of fermented malt
69
VerDate 06
§ 172.765 Succistearin (stearoyl pro- (c) The additive is used as a carrier of pylene glycol hydrogen succinate). vitamin B12 in foods for special dietary The food additive succistearin (ste- use. aroyl propylene glycol hydrogen succi- nate) may be safely used in food in ac- Subpart I—Multipurpose Additives cordance with the following prescribed conditions: § 172.800 Acesulfame potassium. (a) The additive is the reaction prod- Acesulfame potassium (CAS Reg. No. uct of succinic anhydride, fully hydro- 55589–62–3), also known as acesulfame genated vegetable oil (predominantly K, may be safely used as a sweetening C16 or C18 fatty acid chain length), and agent in food in accordance with the propylene glycol. following prescribed conditions: (b) The additive meets the following (a) Acesulfame potassium is the po- specifications: tassium salt of 6-methyl-1,2,3- oxathiazine-4(3H)-one-2,2-dioxide. Acid number 50–150. (b) The additive meets the following Hydroxyl number 15–50. specifications: Succinated ester content 45–75 percent. (1) Purity is not less than 99 percent (c) The additive is used or intended on a dry basis. The purity shall be de- for use as an emulsifier in or with termined by a method titled shortenings and edible oils intended for ‘‘Acesulfame Potassium Assay,’’ which use in cakes, cake mixes, fillings, is incorporated by reference. Copies are icings, pastries, and toppings, in ac- available from the Center for Food cordance with good manufacturing Safety and Applied Nutrition (HFS– practice. 200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or § 172.770 Ethylene oxide polymer. available for inspection at the Office of the FEDERAL REGISTER, 800 North Cap- The polymer of ethylene oxide may itol Street, NW., suite 700, Washington, be safely used as a foam stabilizer in DC 20408. fermented malt beverages in accord- (2) Fluoride content is not more than ance with the following conditions. 30 parts per million, as determined by (a) It is the polymer of ethylene method III of the Fluoride Limit Test oxide having a minimum viscosity of of the Food Chemicals Codex, 3d Ed. 1,500 centipoises in a 1 percent aqueous (1981), p. 511, which is incorporated by ° solution at 25 C. reference. Copies are available from (b) It is used at a level not to exceed the National Academy Press, 2101 Con- 300 parts per million by weight of the stitution Ave. NW., Washington, DC fermented malt beverage. 20418, or available for inspection at the (c) The label of the additive bears di- Office of the Federal Register, 800 rections for use to insure compliance North Capitol Street, NW., suite 700, with paragraph (b) of this section. Washington, DC 20408. (c) The additive may be used in the § 172.775 Methacrylic acid- following foods when standards of iden- divinylbenzene copolymer. tity established under section 401 of Methacrylic acid-divinylbenzene co- the Federal Food, Drug, and Cosmetic polymer may be safely used in food in Act do not preclude such use: accordance with the following pre- (1) Sugar substitute, including granu- scribed conditions: lated, powdered, liquid, and tablet (a) The additive is produced by the form. polymerization of methacrylic acid and (2) [Reserved] divinylbenzene. The divinylbenzene (3) Chewing gum. functions as a cross-linking agent and (4) Dry bases for beverages, instant constitutes a minimum of 4 percent of coffee, and instant tea. the polymer. (5) Dry bases for gelatins, puddings, (b) Aqueous extractives from the ad- and pudding desserts. ditive do not exceed 2 percent (dry (6) Dry bases for dairy product basis) after 24 hours at 25 °C. analogs.
70
VerDate 06
(7) Confections, hard candy, and soft (d) To insure safe use of the additive, candy. the label of the food additive container (8) Baked goods and baking mixes, in- and any intermediate premix thereof cluding frostings, icings, toppings, and shall bear, in addition to the other in- fillings for baked goods. formation required by the act: (9) Yogurt and yogurt-type products. (1) The name of the additive, ‘‘ace- (10) Frozen and refrigerated desserts. tone peroxides’’. (11) Sweet sauces, toppings, and syr- (2) The concentration of the additive ups. expressed in hydrogen peroxide equiva- (12) Alcoholic beverages. lents per 100 grams. (13) Nonalcoholic beverages, includ- (3) Adequate use directions to provide ing beverage bases. a final product that complies with the (d) If the food containing the additive limitations prescribed in paragraph (c) is represented to be for special dietary of this section. uses, it shall be labeled in compliance with part 105 of this chapter. § 172.804 Aspartame. (e) The additive shall be used in ac- The food additive aspartame may be cordance with current good manufac- safely used in food in accordance with turing practice in an amount not to ex- good manufacturing practice as a ceed that reasonably required to ac- sweetening agent and a flavor enhancer complish the intended effect. in foods for which standards of identity [53 FR 28382, July 28, 1988, as amended at 57 established under section 401 of the act FR 57961, Dec. 8, 1992; 59 FR 61540, 61543, 61545, do not preclude such use under the fol- Dec. 1, 1994; 60 FR 21702, May 3, 1995; 63 FR lowing conditions: 36362, July 6, 1998] (a) Aspartame is the chemical 1- methyl N-L-α-aspartyl-L-phenylalanine § 172.802 Acetone peroxides. (C14H18N2O5). The food additive acetone peroxides (b) The additive meets the specifica- may be safely used in flour, and in tions of the ‘‘Food Chemicals Codex,’’ bread and rolls where standards of 3d Ed. (1981) pp. 28–29 and First Supple- identity do not preclude its use, in ac- ment p. 5, which is incorporated by ref- cordance with the following prescribed erence in accordance with 5 U.S.C. conditions: 552(a). Copies are available from the (a) The additive is a mixture of National Academy Press, 2101 Constitu- monomeric and linear dimeric acetone tion Ave. NW., Washington, DC 20418, peroxide, with minor proportions of or may be examined at the Center for higher polymers, manufactured by re- Food Safety and Applied Nutrition’s action of hydrogen peroxide and ace- Library, Food And Drug Administra- tone. tion, 200 C St. SW., rm. 3321, Wash- (b) The additive may be mixed with ington, DC, or at the Office of the Fed- an edible carrier to give a concentra- eral Register, 800 North Capitol St. tion of: (1) 3 grams to 10 grams of hy- NW., suite 700, Washington, DC. drogen peroxide equivalent per 100 (c)(1) When aspartame is used as a grams of the additive, plus carrier, for sugar substitute tablet for sweetening use in flour maturing and bleaching; or hot beverages, including coffee and tea, (2) approximately 0.75 gram of hydro- L-leucine may be used as a lubricant in gen peroxide equivalent per 100 grams the manufacture of such tablets at a of the additive, plus carrier, for use in level not to exceed 3.5 percent of the dough conditioning. weight of the tablet. (c) It is used or intended for use: (1) (2) When aspartame is used in baked In maturing and bleaching of flour in a goods and baking mixes, the amount of quantity not more than sufficient for the additive is not to exceed 0.5 percent such effect; and (2) as a dough-condi- by weight of ready-to-bake products or tioning agent in bread and roll produc- of finished formulations prior to bak- tion at not to exceed the quantity of ing. Generally recognized as safe hydrogen peroxide equivalent nec- (GRAS) ingredients or food additives essary for the artificial maturing ef- approved for use in baked goods shall fect. be used in combination with aspartame
71
VerDate 06
to ensure its functionality as a sweet- compliance with part 105 of this chap- ener in the final baked product. The ter. level of aspartame used in these prod- [42 FR 14491, Mar. 15, 1977, as amended at 48 ucts is determined by an analytical FR 31382, July 8, 1983; 49 FR 22468, May 30, method entitled ‘‘Analytical Method 1984; 51 FR 43000–43002, Nov. 28, 1986; 53 FR for the Determination of Aspartame 20837—20842, June 7, 1988; 53 FR 40879, Oct. 19, and Diketopiperazine in Baked Goods 1988; 53 FR 51273, Dec. 21, 1988; 54 FR 23647, and Baking Mixes,’’ October 8, 1992, June 2, 1989; 54 FR 31333, July 28, 1989; 57 FR 3702, 3703, 3704, Jan. 30, 1992; 58 FR 19771, Apr. which was developed by the Nutrasweet 16, 1993; 58 FR 21097, 21098, 21099, Apr. 19, 1993; Co. Copies are available from the Office 58 FR 48598, Sept. 17, 1993; 61 FR 33656, June of Premarket Approval (HFS–200), Cen- 28, 1996] ter for Food Safety and Applied Nutri- tion, 200 C St. SW., Washington, DC § 172.806 Azodicarbonamide. 20204, or are available for inspection at The food additive azodicarbonamide the Center for Food Safety and Applied may be safely used in food in accord- Nutrition’s Library, Food and Drug Ad- ance with the following prescribed con- ministration, 200 C St. SW., rm. 3321, ditions: Washington, DC 20204, and the Office of (a) It is used or intended for use: the Federal Register, 800 North Capitol (1) As an aging and bleaching ingre- St. NW., suite 700, Washington, DC. dient in cereal flour in an amount not (d) To assure safe use of the additive, to exceed 2.05 grams per 100 pounds of in addition to the other information re- flour (0.0045 percent; 45 parts per mil- quired by the Act: lion). (1) The principal display panel of any (2) As a dough conditioner in bread intermediate mix of the additive for baking in a total amount not to exceed manufacturing purposes shall bear a 0.0045 percent (45 parts per million) by statement of the concentration of the weight of the flour used, including any additive contained therein; quantity of azodicarbonamide added to (2) The label of any food containing flour in accordance with paragraph the additive shall bear, either on the (a)(1) of this section. principal display panel or on the infor- (b) To assure safe use of the additive: mation panel, the following statement: (1) The label and labeling of the addi- tive and any intermediate premix pre- PHENYLKETONURICS: CONTAINS pared therefrom shall bear, in addition PHENYLALANINE to the other information required by the Act, the following: The statement shall appear in the la- (i) The name of the additive. beling prominently and conspicuously as compared to other words, state- (ii) A statement of the concentration or the strength of the additive in any ments, designs or devices and in bold intermediate premixes. type and on clear contrasting back- (2) The label or labeling of the food ground in order to render it likely to additive shall also bear adequate direc- be read and understood by the ordinary tions for use. individual under customary conditions of purchase and use. § 172.808 Copolymer condensates of (3) When the additive is used in a ethylene oxide and propylene oxide. sugar substitute for table use, its label Copolymer condensates of ethylene shall bear instructions not to use in oxide and propylene oxide may be safe- cooking or baking. ly used in food under the following pre- (4) Packages of the dry, free-flowing scribed conditions: additive shall prominently display the (a) The additive consists of one of the sweetening equivalence in teaspoons of following: sugar. (1) α-Hydro-omega-hydroxy-poly (oxy- (e) If the food containing the additive ethylene) poly(oxypropylene)-(55–61 purports to be or is represented for spe- moles)poly(oxyethylene) block copoly- cial dietary uses, it shall be labeled in mer, having a molecular weight range
72
VerDate 06
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- α (3) -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. succinate for fumaric acid as pre- (1) Positive for curdlan. scribed in § 172.810. (2) Assay for curdlan (calculated as (3) The additive identified in para- anhydrous glucose), not less than 80 graph (a)(3) of this section is used: percent. (i) As a surfactant and defoaming (3) pH of 1 percent aqueous suspen- agent, at levels not to exceed 0.05 per- sion, 6.0–7.5. cent by weight, in scald baths for poul- (4) Lead, not more than 0.5 mg/kg. try defeathering, followed by potable (5) Heavy metals (as Pb), not more water rinse. The temperatures of the than 0.002 percent. scald baths shall be not less than 125 (6) Total nitrogen, not more than 0.2 °F. percent. (ii) As a foam control and rinse adju- (7) Loss on drying, not more than 10 vant in hog dehairing machines at a percent. use level of not more than 5 grams per (8) Residue on ignition, not more hog. than 6 percent. (4) The additive identified in para- (9) Gel strength of 2 percent aqueous graph (a)(4) of this section is used as a suspension, not less than 600x103 dyne dough conditioner in yeast-leavened per square centimeter. bakery products for which standards of (10) Aerobic plate count, not more identity established under section 401 than 103 per gram.
73
VerDate 06
(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 per million of the finished beverage. standards of identity established under (e) As a dispersing agent in ‘‘cocoa section 401 of the act do not preclude with dioctyl sodium sulfosuccinate for such use. manufacturing’’ that conforms to the provisions of § 163.117 of this chapter [61 FR 65941, Dec. 16, 1996] and the use limitations prescribed in § 172.810 Dioctyl sodium sulfosuc- § 172.520, in an amount not to exceed 0.4 cinate. percent by weight thereof. (f) As a processing aid and wetting The food additive dioctyl sodium agent in combination with α-hydro- sulfosuccinate, which meets the speci- omega -hydroxy - poly(oxyethylene) - fications of the Food Chemicals Codex, poly-(oxypropylene) (53–59 moles) 3d Ed. (1981), pp. 102–104, which is incor- poly(oxyethylene) (14–16 moles) block porated by reference (copies may be ob- copolymer, having a molecular weight tained from the National Academy range of 3,500–4,125 and a cloud point of Press, 2101 Constitution Ave. NW., 9 °C–12 °C in 10 percent aqueous solu- Washington, DC 20418, or may be exam- tion, for fumaric acid used in fumaric ined at the Office of the Federal Reg- acid-acidulated dry beverage base and ister, 800 North Capitol Street, NW., in fumaric acid-acidulated fruit juice suite 700, Washington, DC 20408), may drinks, when standards of identity do be safely used in food in accordance not preclude such use. The labeling of with the following prescribed condi- the dry beverage base shall bear ade- tions: quate directions for use, and the addi- (a) As a wetting agent in the fol- tives shall be used in such an amount lowing fumaric acid-acidulated foods: that the finished beverage or fruit juice Dry gelatin dessert, dry beverage base, drink will contain not in excess of a and fruit juice drinks, when standards total of 10 parts per million of the of identity do not preclude such use. dioctyl sodium sulfosuccinate-block The labeling of the dry gelatin dessert copolymer combination. and dry beverage base shall bear ade- quate directions for use, and the addi- [42 FR 14491, Mar. 15, 1977, as amended at 49 tive shall be used in such an amount FR 10105, Mar. 19, 1984] that the finished gelatin dessert will contain not in excess of 15 parts per § 172.811 Glyceryl tristearate. million of the additive and the finished The food additive glyceryl tristearate beverage or fruit juice drink will con- may be safely used in food in accord- tain not in excess of 10 parts per mil- ance with the following prescribed con- lion of the additive. ditions: (b) As a processing aid in sugar fac- (a) The food additive (CAS Reg. No. tories in the production of unrefined 555–43–1) is prepared by reacting stearic cane sugar, in an amount not in excess acid with glycerol in the presence of a of 0.5 part per million of the additive suitable catalyst. per percentage point of sucrose in the (b) The food additive meets the fol- juice, syrup, or massecuite being proc- lowing specifications: essed, and so used that the final molas- ses will contain no more than 25 parts Acid number: Not to exceed 1.0. per million of the additive. Iodine number: Not to exceed 1.0. Saponification number: 186–192. (c) As a solubilizing agent on gums Hydroxyl number: Not to exceed 5.0. and hydrophilic colloids to be used in Free glycerol content: Not to exceed 0.5 per- food as stabilizing and thickening cent. agents, when standards of identity do Unsaponifiable matter: Not to exceed 0.5 per- not preclude such use. The additive is cent. used in an amount not to exceed 0.5 Melting point (Class II): 69 °C–73 °C.
74
VerDate 06
(c) The additive is used or intended Uses Limitations for use as follows when standards of As a masking agent for the Not to exceed 0.2 percent in identity established under section 401 bitter aftertaste of sac- the finished beverage. of the Act do not preclude such use: charin used in manufac- tured beverages and bev- Uses Limitations erage bases. As a stabilizer in mono- and Not to exceed 0.02 percent of 1. As a crystallization accel- Not to exceed 1 percent of diglycerides prepared by the mono- and erator in cocoa products, in the combined weight of the glycerolysis of edible diglycerides. imitation chocolate, and in the formulation. fats or oils. compound coatings. 2. As a formulation aid as de- Not to exceed 0.5 percent. (c) To assure safe use of the additive, fined in § 170.3(o)(14) of this chapter, lubricant and release in addition to the other information re- agent as defined in quired by the Act: § 170.3(o)(18) of this chapter, (1) The labeling of the additive shall and surface-finishing agent as defined in § 170.3(o)(30) of bear adequate directions for use of the this chapter in food. additive in compliance with the provi- 3. As a formulation aid as de- Not to exceed 3.0 percent sions of this section. fined in § 170.3(o)(14) of this of the combined weight chapter in confections. of the formulation. (2) The labeling of beverage bases 4. As a formulation aid as de- Not to exceed 1.0 percent containing the additive shall bear ade- fined in § 170.3(o)(14) of this of the combined weight quate directions for use to provide that chapter in fats and oils as de- of the formulation. fined in § 170.3 (n)(12) of this beverages prepared therefrom shall chapter. contain no more than 0.2 percent gly- 5. As a winterization and frac- Not to exceed 0.5 percent cine. tionation aid in fat and oil by weight of the proc- processing. essed fat or oil. [42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984] (d) To assure safe use of the additive: (1) In addition to the other informa- § 172.814 Hydroxylated lecithin. tion required by the act, the label or The food additive hydroxylated labeling of the additive shall bear the lecithin may be safely used as an emul- name of the additive. sifier in foods in accordance with the (2) The label of the additive shall following conditions: bear adequate directions to provide a (a) The additive is obtained by the final product that complies with the treatment of lecithin in one of the fol- limitations prescribed in paragraph (c) lowing ways, under controlled condi- of this section. tions whereby the separated fatty acid [53 FR 21632, June 9, 1988, as amended at 59 fraction of the resultant product has FR 24924, May 13, 1994] an acetyl value of 30 to 38: (1) With hydrogen peroxide, benzoyl § 172.812 Glycine. peroxide, lactic acid, and sodium hy- The food additive glycine may be droxide. safely used for technological purposes (2) With hydrogen peroxide, acetic in food in accordance with the fol- acid, and sodium hydroxide. lowing prescribed conditions: (b) It is used or intended for use, in (a) The additive complies with the accordance with good manufacturing specifications of the ‘‘Food Chemicals practice, as an emulsifier in foods, ex- Codex,’’ 3d Ed. (1981), p. 140, which is in- cept for those standardized foods that corporated by reference. Copies may be do not provide for such use. obtained from the National Academy (c) To assure safe use of the additive, Press, 2101 Constitution Ave. NW., the label of the food additive container Washington, DC 20418, or may be exam- shall bear, in addition to the other in- ined at the Office of the Federal Reg- formation required by the Act: ister, 800 North Capitol Street, NW., (1) The name of the additive, suite 700, Washington, DC 20408. ‘‘hydroxylated lecithin’’. (b) The additive is used or intended (2) Adequate directions for its use. for use as follows:
75
VerDate 06
§ 172.816 Methyl glucoside-coconut oil the limitations prescribed in paragraph ester. (b) of this section. Methyl glucoside-coconut oil ester § 172.820 Polyethylene glycol (mean may be safely used in food in accord- molecular weight 200–9,500). ance with the following conditions: (a) It is the methyl glucoside-coconut Polyethylene glycol identified in this oil ester having the following specifica- section may be safely used in food in tions: accordance with the following pre- 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 the presence of air and a suitable cata- ETHYLENE GLYCOL AND DIETHYLENE GLYCOL lyst which is not a food additive as so CONTENT OF POLYETHYLENE GLYCOLS defined. The resultant product meets The analytical method for determining the following specifications: ethylene glycol and diethylene glycol is as follows: Acid number: Maximum 15. Iodine number: Maximum 15. APPARATUS Saponification number: 225–240. Gas chromatograph with hydrogen flame Hydroxyl number: 30–45. ionization detector (Varian Aerograph 600 D Unsaponifiable material: Maximum 0.8 per- or equivalent). The following conditions cent. shall be employed with the Varian ± ° Refractive index (butyro): 60 1 at 48 C. Aerograph 600 D gas chromatograph: (b) It is used or intended for use as a Column temperature: 165 °C. ° crystallization inhibitor in vegetable Inlet temperature: 260 C. Carrier gas (nitrogen) flow rate: 70 milli- oils and as a release agent in vegetable liters per minute. oils and vegetable shortenings, where- Hydrogen and air flow to burner: Optimize by the additive does not exceed 0.125 to give maximum sensitivity. percent of the combined weight of the Sample size: 2 microliters. oil or shortening. Elution time: Ethylene glycol: 2.0 minutes. (c) To insure safe use of the additive, Diethylene glycol: 6.5 minutes. the label and labeling of the additive Recorder: ¥0.5 to +1.05 millivolt, full span, container shall bear, in addition to the 1 second full response time. Syringe: 10-microliter (Hamilton 710 N or other information required by the Act: equivalent). (1) The name of the additive. Chromatograph column: 5 feet × 1⁄8 inch. (2) Adequate directions to provide an I.D. stainless steel tube packed with sorbitol oil or shortening that complies with (Mathieson-Coleman-Bell 2768 Sorbitol
76
VerDate 06
SX850, or equivalent) 12 percent in H2O by (3) As an adjuvant in dispersing vita- weight on 60–80 mesh nonacid washed diato- min and/or mineral preparations. maceous earth (Chromosorb W. Johns-Man- (4) As a coating on sodium nitrite to ville, or equivalent). inhibit hygroscopic properties. REAGENTS AND MATERIALS (d) Limitations. (1) It is used in an amount not greater than that required Carrier gas, nitrogen: Commercial grade in cylinder equipped with reducing regulator to to produce the intended physical or provide 50 p.s.i.g. to the gas chromatograph. technical effect. Ethylene glycol: Commercial grade. Purify (2) A tolerance of zero is established if necessary, by distillation. for residues of polyethylene glycol in Diethylene glycol: Commercial grade. Pu- milk. rify, if necessary, by distillation. Glycol standards: Prepare [42 FR 14491, Mar. 15, 1977, as amended at 49 chromatographic standards by dissolving FR 10105, Mar. 19, 1984] known amounts of ethylene glycol and diethylene glycol in water. Suitable con- § 172.822 Sodium lauryl sulfate. centrations for standardization range from 1 The food additive sodium lauryl sul- to 6 milligrams of each component per milli- fate may be safely used in food in ac- liter (for example 10 milligrams diluted to cordance with the following conditions: volume in a 10-milliliter volumetric flask is (a) The additive meets the following equivalent to 1 milligram per milliliter). specifications: STANDARDIZATION (1) It is a mixture of sodium alkyl Inject a 2-microliter aliquot of the glycol sulfates consisting chiefly of sodium standard into the gas chromatograph em- lauryl sulfate [CH2(CH2)10CH2OSO2Na]. ploying the conditions described above. (2) It has a minimum content of 90 Measure the net peak heights for the ethyl- percent sodium alkyl sulfates. ene glycol and for the diethylene glycol. (b) It is used or intended for use: Record the values as follows: (1) As an emulsifier in or with egg A=Peak height in millimeters of the ethyl- whites whereby the additive does not ene glycol peak. exceed the following limits: B=milligrams of ethylene glycol per milli- 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 not exceed 25 parts per million of the chromatograph. Measure the heights, in mil- finished beverage and such beverage limeters, of the ethylene glycol peak and of the diethylene glycol peak and record as E base is not for use in a food for which and F, respectively. a standard of identity established under section 401 of the Act precludes Percent ethylene glycol=(E×B)/(A × sample such use. weight in grams) (ii) Fumaric acid-acidulated fruit Percent diethylene glycol=(F × D)/(C × juice drinks whereby the additive does sample weight in grams) not exceed 25 parts per million of the (c) Uses. It may be used, except in finished fruit juice drink and it is not milk or preparations intended for addi- used in a fruit juice drink for which a tion to milk, as follows: standard of identity established under (1) As a coating, binder, plasticizing section 401 of the Act precludes such agent, and/or lubricant in tablets used use. for food. (4) As a wetting agent at a level not (2) As an adjuvant to improve flavor to exceed 10 parts per million in the and as a bodying agent in nonnutritive partition of high and low melting frac- sweeteners identified in § 180.37 of this tions of crude vegetable oils and ani- chapter. mal fats, provided that the partition
77
VerDate 06
step is followed by a conventional re- § 172.826 Sodium stearyl fumarate. fining process that includes alkali neu- Sodium stearyl fumarate may be tralization and deodorization of the safely used in food in accordance with fats and oils. the following conditions: (c) To insure the safe use of the addi- (a) It contains not less than 99 per- tive, the label of the food additive con- cent sodium stearyl fumarate cal- tainer shall bear, in addition to the culated on the anhydrous basis, and other information required by the Act: not more than 0.25 percent sodium ste- (1) The name of the additive, sodium aryl maleate. lauryl sulfate. (b) The additive is used or intended (2) Adequate use directions to provide for use: a final product that complies with the (1) As a dough conditioner in yeast- limitations prescribed in paragraph (b) of this section. leavened bakery products in an amount not to exceed 0.5 percent by weight of [42 FR 14491, Mar. 15, 1977, as amended at 43 the flour used. FR 18668, May 2, 1978] (2) As a conditioning agent in dehy- drated potatoes in an amount not to § 172.824 Sodium mono- and dimethyl exceed 1 percent by weight thereof. naphthalene sulfonates. (3) As a stabilizing agent in The food additive sodium mono- and nonyeast-leavened bakery products in dimethyl naphthalene sulfonates may an amount not to exceed 1 percent by be safely used in accordance with the weight of the flour used. following prescribed conditions: (4) As a conditioning agent in proc- (a) The additive has a molecular essed cereals for cooking in an amount weight range of 245–260. not to exceed 1 percent by weight of (b) The additive is used or intended the dry cereal, except for foods for for use: which standards of identity preclude (1) In the crystallization of sodium such use. carbonate in an amount not to exceed (5) As a conditioning agent in starch- 250 parts per million of the sodium car- thickened or flour-thickened foods in bonate. Such sodium carbonate is used an amount not to exceed 0.2 percent by or intended for use in potable water weight of the food. systems to reduce hardness and aid in sedimentation and coagulation by rais- § 172.828 Acetylated monoglycerides. ing the pH for the efficient utilization of other coagulation materials. The food additive acetylated monoglycerides may be safely used in (2) As an anticaking agent in sodium nitrite at a level not in excess of 0.1 or on food in accordance with the fol- percent by weight thereof for author- lowing prescribed conditions: ized uses in cured fish and meat. (a) The additive is manufactured by: (c) In addition to the general labeling (1) The interesterification of edible requirements of the Act: fats with triacetin and in the presence (1) Sodium carbonate produced in ac- of catalytic agents that are not food cordance with paragraph (b)(1) of this additives or are authorized by regula- section shall be labeled to show the tion, followed by a molecular distilla- presence of the additive and its label or tion or by steam stripping; or labeling shall bear adequate directions (2) The direct acetylation of edible for use. monoglycerides with acetic anhydride (2) Sodium nitrite produced in ac- without the use of catalyst or molec- cordance with paragraph (b)(2) of this ular distillation, and with the removal section shall bear the labeling required by vacuum distillation, if necessary, of by § 172.175 and a statement declaring the acetic acid, acetic anhydride, and the presence of sodium mono- and di- triacetin. methyl naphthalene sulfonates. (b) The food additive has a Reichert- Meissl value of 75–200 and an acid value [42 FR 14491, Mar. 15, 1977, as amended at 63 of less than 6. FR 7069, Feb. 12, 1998]
78
VerDate 06
(c) The food additive is used at a 4th ed. (1996), pp. 398–400, which is in- level not in excess of the amount rea- corporated by reference in accordance sonably required to produce its in- with 5 U.S.C. 552(a) and 1 CFR part 51. tended effect in food, or in food-proc- Copies are available from the the Divi- essing, food-packing, or food-storage sion of Product Policy (HFS–206), Cen- equipment. ter for Food Safety and Applied Nutri- tion, Food and Drug Administration, [42 FR 14491, Mar. 15, 1977, as amended at 50 FR 3508, Jan. 25, 1985] 200 C St. SW., Washington, DC 20204– 0001, or may be examined at the Center § 172.830 Succinylated monoglycerides. for Food Safety and Applied Nutri- The food additive succinylated tion’s Library, 200 C St. SW., rm. 3321, monoglycerides may be safely used in Washington, DC 20204–0001, or the Of- food in accordance with the following fice of the Federal Register, 800 North prescribed conditions: Capitol St. NW., suite 700, Washington, (a) The additive is a mixture of semi- DC. and neutral succinic acid esters of (c) The additive may be used as a mono- and diglycerides produced by the sweetener in the following foods: succinylation of a product obtained by (1) Baked goods and baking mixes; the glycerolysis of edible fats and oils, (2) Beverages and beverage bases; or by the direct esterification of glyc- (3) Chewing gum; erol with edible fat-forming fatty (4) Coffee and tea; acids. (5) Dairy product analogs; (b) The additive meets the following (6) Fats and oils (salad dressing); specifications: (7) Frozen dairy desserts; (8) Fruit and water ices; Succinic acid content: 14.8%–25.6% (9) Gelatins, puddings, and fillings; Melting point: 50 °C–60 °C. (10) Jams and jellies; Acid number: 70–120 (11) Milk products; (c) The additive is used or intended (12) Processed fruits and fruit juices; for use in the following foods: (13) Sugar substitutes (for table use); (1) As an emulsifier in liquid and (14) Sweet sauces, toppings, and syr- plastic shortenings at a level not to ex- ups; ceed 3 percent by weight of the short- (15) Confections and frostings. ening. (d) If the food containing the additive (2) As a dough conditioner in bread purports to be or is represented to be baking, when such use is permitted by for special dietary use, it shall be la- an appropriate food standard, at a level beled in compliance with part 105 of not to exceed 0.5 percent by weight of this chapter. the flour used. [63 FR 16433, Apr. 3, 1998]
§ 172.831 Sucralose. § 172.832 Monoglyceride citrate. The food additive sucralose may be A food additive that is a mixture of safely used as a sweetening agent in glyceryl monooleate and its citric acid foods in accordance with current good monoester manufactured by the reac- manufacturing practice in an amount tion of glyceryl monooleate with citric not to exceed that reasonably required acid under controlled conditions may to accomplish the intended technical be safely used as a synergist and solu- effect in foods for which standards of bilizer for antioxidants in oils and fats, identity established under section 401 when used in accordance with the con- of the Federal Food, Drug, and Cos- ditions prescribed in this section. metic Act do not preclude such use (a) The food additive meets the fol- under the following conditions: lowing specifications: (a) Sucralose is the chemical 1,6- dichloro-1,6-dideoxy-β-D- Acid number, 70–100. fructofuranosyl-4-chloro-4-deoxy-α-D- Total citric acid (free and combined), 14 per- galactopyranoside (CAS Reg. No. 56038– cent–17 percent. 13–2). (b) It is used, or intended for use, in (b) The additive meets the specifica- antioxidant formulations for addition tions of the ‘‘Food Chemicals Codex,’’ to oils and fats whereby the additive
79
VerDate 06
does not exceed 200 parts per million of Use Limitations the combined weight of the oil or fat 4. As an emulsifier in icings Not to exceed 0.5 percent by and the additive. and icing mixes. weight of the finished (c) To assure safe use of the additive: icings. (1) The container label shall bear, in 5. As an emulsifier in frozen Not to exceed 0.2 percent by desserts. weight of the finished fro- addition to the other information re- zen desserts. quired by the Act, the name of the ad- 6. As an emulsifier in edible Not to exceed 0.4 percent by ditive. vegetable fat-water emul- weight of the finished vege- (2) The label or accompanying label- sions intended for use as table fat-water emulsions. substitutes for milk or ing shall bear adequate directions for cream in beverage coffee. the use of the additive which, if fol- lowed, will result in a food that com- (d) When the name ‘‘polyglycerate plies with the requirements of this sec- 60’’ is used in labeling it shall be fol- tion. lowed by either ‘‘polyoxyethylene (20) mono-and diglycerides of fatty acids’’ § 172.834 Ethoxylated mono- and or ‘‘ethoxylated mono- and diglycerides. diglycerides’’ in parentheses. The food additive ethoxylated mono- [42 FR 14491, Mar. 15, 1977, as amended at 42 and diglycerides (polyoxyethylene (20) FR 37973, July 26, 1977; 50 FR 49536, Dec. 3, mono- and diglycerides of fatty acids) 1985] (polyglycerate 60) may be safely used in food in accordance with the fol- § 172.836 Polysorbate 60. lowing prescribed conditions: The food additive polysorbate 60 (a) The food additive is manufactured (polyoxyethylene (20) sorbitan mono- by: stearate) which is a mixture of (1) Glycerolysis of edible fats pri- polyoxyethylene ethers of mixed par- marily composed of stearic, palmitic, tial stearic and palmitic acid esters of and myristic acids; or sorbitol anhydrides and related com- (2) Direct esterification of glycerol pounds, may be safely used in food in with a mixture of primarily stearic, accordance with the following pre- palmitic, and myristic acids; scribed conditions: to yield a product with less than 0.3 (a) The food additive is manufactured acid number and less than 0.2 percent by reacting stearic acid (usually con- water, which is then reacted with taining associated fatty acids, chiefly ethylene oxide. palmitic) with sorbitol to yield a prod- uct with a maximum acid number of 10 (b) The additive meets the following and a maximum water content of 0.2 specifications: percent, which is then reacted with Saponification number, 65–75. ethylene oxide. Acid number, 0–2. (b) The food additive meets the fol- Hydroxyl number, 65–80. lowing specifications: Oxyethylene content, 60.5–65.0 percent. Saponification number 45–55. (c) The additive is used or intended Acid number 0–2. for use in the following foods when Hydroxyl number 81–96. standards of identity established under Oxyethylene content 65 percent–69.5 percent. section 401 of the Act do not preclude (c) It is used or intended for use as such use: follows: Use Limitations (1) As an emulsifier in whipped edible oil topping with or without one or a 1. As an emulsifier in pan-re- Not to exceed levels required combination of the following: lease agents for and as a to produce the intended ef- (i) Sorbitan monostearate; dough conditioner in yeast- fects, total not to exceed leavened bakery products. 0.5 percent by weight of (ii) Polysorbate 65; the flour used. (iii) Polysorbate 80; 2. As an emulsifier in cakes Not to exceed 0.5 percent by and cake mixes. weight of the dry ingredi- whereby the maximum amount of the ents. additive or additives used does not ex- 3. As an emulsifier in Not to exceed 0.45 percent ceed 0.4 percent of the weight of the whipped vegetable oil top- by weight of the finished pings and topping mixes. whipped vegetable oil top- finished whipped edible oil topping; ex- pings. cept that a combination of the additive
80
VerDate 06
with sorbitan monostearate may be 0.46 percent, nor shall the polysorbate used in excess of 0.4 percent, provided 65 exceed 0.32 percent or the sorbitan that the amount of the additive does monostearate exceed 0.7 percent, and not exceed 0.77 percent and the amount no combination of these emulsifiers of sorbitan monostearate does not ex- shall exceed 1 percent of the weight of ceed 0.27 percent of the weight of the the cake icing or cake filling. finished whipped edible oil topping. (6) To impart greater opacity to (2) As an emulsifier in cakes and cake sugar-type confection coatings where- mixes, with or without one or a com- by the maximum amount of the addi- bination of the following: tive does not exceed 0.2 percent of the (i) Polysorbate 65. weight of the finished sugar coating. (ii) Sorbitan monostearate. (7) As an emulsifier in nonstandard- ized dressings whereby the maximum When used alone, the maximum amount of the additive does not exceed amount of polysorbate 60 shall not ex- 0.3 percent of the weight of the finished ceed 0.46 percent of the cake or cake dressings. mix, on a dry-weight basis. When used (8) As an emulsifier, alone or in com- with polysorbate 65 and/or sorbitan bination with polysorbate 80, in monostearate, it shall not exceed 0.46 shortenings and edible oils intended for percent, nor shall the polysorbate 65 use in foods as follows, when standards exceed 0.32 percent or the sorbitan of identity established under section monostearate exceed 0.61 percent, and 401 of the act do not preclude such use: no combination of these emulsifiers (i) It is used alone in an amount not shall exceed 0.66 percent of the cake or to exceed 1 percent of the weight of the cake mix, all calculated on a dry- finished shortening or oil. weight basis. (ii) It is used with polysorbate 80 in (3) As an emulsifier, alone or in com- any combination providing no more bination with sorbitan monostearate, than 1 percent of polysorbate 60 and no in nonstandardized confectionery coat- more than 1 percent of polysorbate 80, ings and standardized cacao products provided that the total combination 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
81
VerDate 06
not to exceed 0.5 percent by weight of § 172.838 Polysorbate 65. the flour used. The food additive polysorbate 65 (12) As an emulsifier, alone or in (polyoxyethylene (20) sorbitan combination with sorbitan monostea- tristearate), which is a mixture of rate, in the minimum quantity re- polyoxyethylene ethers of mixed ste- quired to accomplish the intended ef- aric acid esters of sorbitol anhydrides fect, in formulations of white mineral and related compounds, may be safely oil conforming with § 172.878 and/or pe- used in food in accordance with the fol- troleum wax conforming with § 172.886 lowing prescribed conditions: for use as protective coatings on raw (a) The food additive is manufactured fruits and vegetables. by reacting stearic acid (usually con- (13) As a dispersing agent in artifi- taining associated fatty acids, chiefly cially sweetened gelatin desserts and in palmitic) with sorbitol to yield a prod- artificially sweetened gelatin dessert uct with a maximum acid number of 15 mixes, whereby the amount of the addi- and a maximum water content of 0.2 tive does not exceed 0.5 percent on a percent, which is then reacted with dry-weight basis. ethylene oxide. (14) As an emulsifier in chocolate fla- (b) The food additive meets the fol- vored syrups, whereby the maximum lowing specifications: amount of the additive does not exceed Saponification number 88–98. 0.05 percent in the finished product. Acid number 0–2. (15) As a surfactant and wetting Hydroxyl number 44–60. agent for natural and artificial colors Oxyethylene content 46 percent–50 percent. in food as follows: (c) The additive is used, or intended (i) In powdered soft drink mixes in an for use, as follows: amount not to exceed 4.5 percent by (1) As an emulsifier in ice cream, fro- weight of the mix. zen custard, ice milk, fruit sherbet and (ii) In sugar-based gelatin dessert 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 (iii) In artificially sweetened gelatin amount of the additives, alone or in dessert mixes in an amount not to ex- combination, does not exceed 0.1 per- ceed 3.6 percent by weight of the mix. cent of the finished frozen dessert. (iv) In sugar-based pudding mixes in (2) As an emulsifier in cakes and cake an amount not to exceed 0.5 percent by mixes, with or without one or a com- weight of the mix. bination of the following: (i) Sorbitan monostearate. (v) In artificially sweetened pudding (ii) Polysorbate 60. mixes in an amount not to exceed 0.5 percent by weight of the mix. 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- stearate exceed 0.61 percent or the (ii) A statement of the concentration polysorbate 60 exceed 0.46 percent, and or strength of the additive in any in- no combination of these emulsifiers termediate premixes. shall exceed 0.66 percent of the cake or (2) The label or labeling shall bear cake mix, all calculated on a dry- adequate directions to provide a final weight basis. product that complies with the limita- (3) As an emulsifier in whipped edible tions prescribed in paragraph (c) of this oil topping with or without one or a section. combination of the following: [42 FR 14491, Mar. 15, 1977, as amended at 43 (i) Sorbitan monostearate; FR 2871, Jan. 25, 1978; 45 FR 58836, Sept. 5, (ii) Polysorbate 60; 1980; 46 FR 8466, Jan. 27, 1981] (iii) Polysorbate 80;
82
VerDate 06
whereby the maximum amount of the safely used in food in accordance with additive or additives used does not ex- the following prescribed conditions: ceed 0.4 percent of the weight of the (a) The food additive is manufactured finished whipped edible oil topping. by reacting oleic acid (usually con- (4) As an emulsifier in solid-state, ed- taining associated fatty acids) with ible vegetable fat-water emulsions in- sorbitol to yield a product with a max- tended for use as substitutes for milk imum acid number of 7.5 and a max- or cream in beverage coffee, with or imum water content of 0.5 percent, without one or a combination of the which is then reacted with ethylene following: oxide. (i) Sorbitan monostearate. (b) The food additive meets the fol- (ii) Polysorbate 60. lowing specifications: The maximum amount of the additive Saponification number 45–55. or additives shall not exceed 0.4 per- Acid number 0–2. cent by weight of the finished edible Hydroxyl number 65–80. vegetable fat-water emulsion. Oxyethylene content 65 percent–69.5 percent. (5) As an emulsifier in cake icings (c) The additive is used or intended and cake fillings, with or without one for use as follows: or a combination of the following: (1) An emulsifier in ice cream, frozen (i) Sorbitan monostearate. custard, ice milk, fruit sherbet, and (ii) Polysorbate 60. nonstandardized frozen desserts, when When used alone, the maximum used alone or in combination with amount of polysorbate 65 shall not ex- polysorbate 65 whereby the maximum ceed 0.32 percent of the weight of the amount of the additives, alone or in cake icing or cake filling. When used combination, does not exceed 0.1 per- with sorbitan monostearate and/or cent of the finished frozen dessert. polysorbate 60, it shall not exceed 0.32 (2) In yeast-defoamer formulations percent, nor shall the sorbitan mono- whereby the maximum amount of the stearate exceed 0.7 percent or the poly- additive does not exceed 4 percent of sorbate 60 exceed 0.46 percent, and no the finished yeast defoamer and the combination of these emulsifiers shall maximum amount of the additive in exceed 1 percent of the weight of the the yeast from such use does not ex- cake icing or cake filling. ceed 4 parts per million. (d) To assure safe use of the additive, (3) As a solubilizing and dispersing in addition to the other information re- agent in pickles and pickle products, quired by the Act: whereby the maximum amount of the 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
83
VerDate 06
not exceed 475 milligrams from the rec- whereby the amount of the additive ommended daily dose of the prepara- does not exceed 0.082 percent on a dry- tions. weight basis. (5) As a surfactant in the production (12) As an adjuvant added to herbi- of coarse crystal sodium chloride cide use and plant-growth regulator whereby the maximum amount of the use dilutions by a grower or applicator additive in the finished sodium chlo- prior to application of such dilutions to ride does not exceed 10 parts per mil- the growing crop. Residues resulting lion. from such use are exempt from the re- (6) In special dietary foods, as an quirement of a tolerance. When so used emulsifier for edible fats and oils, with or intended for use, the additive shall directions for use which provide for the be exempt from the requirements of ingestion of not more than 360 milli- paragraph (d)(1) of this section. grams of polysorbate 80 per day. (13) As a defoaming agent in the prep- (7) As a solubilizing and dispersing aration of the creaming mixture for agent for dill oil in canned spiced green cottage cheese and lowfat cottage beans, not to exceed 30 parts per mil- cheese, as identified in §§ 133.128 and lion. 133.131 of this chapter, respectively, (8) As an emulsifier, alone or in com- whereby the amount of the additive bination with polysorbate 60, in does not exceed .008 percent by weight shortenings and edible oils intended for of the finished products. use in foods as follows, when standards (14) As a surfactant and wetting of identity established under section agent for natural and artificial colors 401 of the act do not preclude such use: for use in barbecue sauce where the (i) It is used alone in an amount not level of the additive does not exceed to exceed 1 percent of the weight of the 0.005 percent by weight of the barbecue finished shortening or oil. sauce. (ii) It is used with polysorbate 60 in (d) To assure safe use of the additive, any combination providing no more in addition to the other information re- than 1 percent of polysorbate 80 and no quired by the Act: more than 1 percent of polysorbate 60, (1) The label of the additive and any provided that the total combination intermediate premixes shall bear: does not exceed 1 percent of the fin- 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; (iii) Polysorbate 65; § 172.841 Polydextrose. whereby the maximum amount of the Polydextrose as identified in this sec- additive or additives used does not ex- tion may be safely used in food in ac- ceed 0.4 percent of the weight of the cordance with the following prescribed finished whipped edible oil topping. conditions: (10) It is used as a wetting agent in (a)(1) Polydextrose (CAS Reg. No. scald water for poultry defeathering, 68424–04–4) is a partially metabolizable followed by potable water rinse. The water-soluble polymer prepared by the concentration of the additive in the condensation of a melt which consists scald water does not exceed 0.0175 per- either of approximately 89 percent D- cent. glucose, 10 percent sorbitol, and 1 per- (11) As a dispersing agent in gelatin cent citric acid or of approximately 90 desserts and in gelatin dessert mixes, percent D-glucose, 10 percent sorbitol,
84
VerDate 06
and 0.1 percent phosphoric acid, on a § 172.842 Sorbitan monostearate. weight basis. The food additive sorbitan monostea- (2) Polydextrose may be partially rate, which is a mixture of partial ste- neutralized with potassium hydroxide, aric and palmitic acid esters of sorbitol or partially reduced by transition anhydrides, may be safely used in or on metal catalytic hydrogenation in aque- food in accordance with the following ous solution. prescribed conditions: (b) The additive meets the specifica- (a) The food additive is manufactured tions of the ‘‘Food Chemicals Codex,’’ by reacting stearic acid (usually con- 4th ed. (1996), pp. 297–300, which is in- taining associated fatty acids, chiefly corporated by reference in accordance palmitic) with sorbitol to yield essen- with 5 U.S.C. 552(a) and 1 CFR part 51. tially a mixture of esters. Copies are available from the National (b) The food additive meets the fol- Academy Press, 2101 Constitution Ave. lowing specifications: NW., Washington, DC 20418, or may be examined at the Center for Food Safety Saponification number, 147–157 Acid number, 5–10 and Applied Nutrition’s Library, Food Hydroxyl number, 235–260 and Drug Administration, 200 C St. SW., rm. 3321, Washington, DC, or at (c) It is used or intended for use, the Office of the Federal Register, 800 alone or in combination with poly- North Capitol St. NW., suite 700, Wash- sorbate 60 as follows: ington, DC. (1) As an emulsifier in whipped edible (c) Polydextrose is used in accord- oil topping with or without one or a ance with current good manufacturing combination of the following: practices as a bulking agent, formula- (i) Polysorbate 60; tion aid, humectant, and texturizer in (ii) Polysorbate 65; the following foods when standards of (iii) Polysorbate 80; identity established under section 401 whereby the maximum amount of the of the act do not preclude such use: additive or additives used does not ex- Baked goods and baking mixes (re- ceed 0.4 percent of the weight of the stricted to fruit, custard, and pudding- finished whipped edible oil topping; ex- filled pies; cakes; cookies; and similar cept that a combination of the additive baked products); chewing gum; confec- with polysorbate 60 may be used in ex- tions and frostings; dressings for sal- cess of 0.4 percent: Provided, That the ads; frozen dairy desserts and mixes; amount of the additive does not exceed fruit spreads; gelatins, puddings and 0.27 percent and the amount of poly- fillings; hard and soft candy; peanut sorbate 60 does not exceed 0.77 percent spread; sweet sauces, toppings, and syr- of the weight of the finished whipped ups; film coatings on single and mul- edible oil topping. tiple vitamin and mineral supplement (2) As an emulsifier in cakes and cake tablets. 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] basis.
85
VerDate 06
(3) As an emulsifier, alone or in com- conforming with § 172.886 for use as pro- bination with polysorbate 60 in non- tective coatings on raw fruits and vege- standardized confectionery coatings tables. and standardized cacao products speci- (d) To assure safe use of the additive, fied in §§ 163.123, 163.130, 163.135, 163.140, in addition to the other information re- 163.145, and 163.150 of this chapter, as quired by the Act: follows: (1) The label of the additive and any (i) It is used alone in an amount not intermediate premixes shall bear: to exceed 1 percent of the weight of the (i) The name of the additive. finished nonstandardized confectionery (ii) A statement of the concentration coating or standardized cacao product. or strength of the additive in any in- (ii) It is used with polysorbate 60 in termediate premixes. any combination of up to 1 percent sor- (2) The label or labeling shall bear bitan monostearate and up to 0.5 per- adequate directions to provide a final cent polysorbate 60 provided that the product that complies with the limita- total combination does not exceed 1 tions prescribed in paragraph (c) of this percent of the weight of the finished section. nonstandardized confectionery coating [42 FR 14491, Mar. 15, 1977, as amended at 43 or standardized cacao product. FR 2871, Jan. 20, 1978] (4) As an emulsifier in cake icings and cake fillings, with or without one § 172.844 Calcium stearoyl-2-lactylate. or a combination of the following: The food additive calcium stearoyl-2- (i) Polysorbate 65. lactylate may be safely used in or on (ii) Polysorbate 60. food in accordance with the following When used alone, the maximum prescribed conditions: amount of sorbitan monostearate shall (a) The additive, which is a mixture not exceed 0.7 percent of the weight of of calcium salts of stearoyl lactylic the cake icing or cake filling. When acids and minor proportions of other used with polysorbate 65 and/or poly- calcium salts of related acids, is manu- sorbate 60, it shall not exceed 0.7 per- factured by the reaction of stearic acid cent, nor shall the polysorbate 65 ex- and lactic acid and conversion to the ceed 0.32 percent or the polysorbate 60 calcium salts. exceed 0.46 percent, and no combina- (b) The additive meets the following tion of these emulsifiers shall exceed 1 specifications: percent of the weight of the cake icing Acid number, 50–86. or cake filling. Calcium content, 4.2–5.2 percent. (5) As an emulsifier in solid-state, ed- Lactic acid content, 32–38 percent. ible vegetable fat-water emulsions in- Ester number, 125–164. tended for use as substitutes for milk (c) It is used or intended for use as or cream in beverage coffee, with or follows: without one or a combination of the (1) As a dough conditioner in yeast- following: leavened bakery products and prepared (i) Polysorbate 60. mixes for yeast-leavened bakery prod- (ii) Polysorbate 65. ucts in an amount not to exceed 0.5 The maximum amount of the additive part for each 100 parts by weight of or additives shall not exceed 0.4 per- flour used. cent by weight of the finished edible (2) As a whipping agent in: vegetable fat-water emulsion. (i) Liquid and frozen egg white at a (6) It is used alone as a rehydration level not to exceed 0.05 percent. aid in the production of active dry (ii) Dried egg white at a level not to yeast in an amount not to exceed 1 per- exceed 0.5 percent. cent by weight of the dry yeast. (iii) Whipped vegetable oil topping at (7) As an emulsifier, alone or in com- a level not to exceed 0.3 percent of the bination with polysorbate 60, in the weight of the finished whipped vege- minimum quantity required to accom- table oil topping. plish the intended effect, in formula- (3) As a conditioning agent in dehy- tions of white mineral oil conforming drated potatoes in an amount not to with § 172.878 and/or petroleum wax exceed 0.5 percent by weight thereof.
86
VerDate 06
(d) To assure safe use of the additive: weight of the finished edible fat-water (1) The label and labeling of the food emulsion. additive and any intermediate premix (4) As a formulation aid, processing prepared therefrom shall bear, in addi- aid, or surface-active agent in dehy- tion to the other information required drated potatoes, in an amount not to by the act, the following: exceed 0.5 percent of the dry weight of (i) The name of the additive. the food. (ii) A statement of the concentration (5) As an emulsifier, stabilizer, or or strength of the additive in any in- texturizer in snack dips, at a level not termediate premixes. to exceed 0.2 percent by weight of the (2) The label or labeling of the food finished product. additive shall also bear adequate direc- (6) As an emulsifier, stabilizer, or tions of use to provide a finished food texturizer in cheese substitutes and that complies with the limitations pre- imitations and cheese product sub- scribed in paragraph (c) of this section. stitutes and imitations, at a level not to exceed 0.2 percent by weight of the § 172.846 Sodium stearoyl lactylate. finished food. (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- tic acid and conversion to the sodium [45 FR 51767, Aug. 5, 1980, as amended at 49 salts. FR 10105, Mar. 19, 1984; 50 FR 49536, Dec. 3, (b) The additive meets the specifica- 1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333, Jan. 27, 1986] tions of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), pp. 300–301, which is incor- § 172.848 Lactylic esters of fatty acids. porated by reference. Copies may be obtained from the National Academy Lactylic esters of fatty acids may be Press, 2101 Constitution Ave. NW., safely used in food in accordance with Washington, DC 20418, or may be exam- the following prescribed conditions: ined at the Office of the Federal Reg- (a) They are prepared from lactic ister, 800 North Capitol Street, NW., acid and fatty acids meeting the re- suite 700, Washington, DC 20408. quirements of § 172.860(b) and/or oleic acid derived from tall oil fatty acids (c) It is used or intended for use as meeting the requirements of § 172.862. follows when standards of identity es- (b) They are used as emulsifiers, plas- tablished under section 401 of the Act ticizers, or surface-active agents in the do not preclude such use: following foods, when standards of (1) As a dough strengthener, emulsi- identity do not preclude their use: fier, or processing aid in baked prod- ucts, pancakes, and waffles, in an Foods Limitations amount not to exceed 0.5 part for each Bakery mixes ...... 100 parts by weight of flour used. Baked products ...... (2) As a surface-active agent, emulsi- Cake icings, fillings, and toppings fier, or stabilizer in icings, fillings, Dehydrated fruits and vegetables puddings, and toppings, at a level not Dehydrated fruit and vegetable juices. to exceed 0.2 percent by weight of the Edible vegetable fat-water emul- As substitutes for milk or finished food. sions. cream in beverage cof- (3) As an emulsifier or stabilizer in fee. Frozen desserts ...... liquid and solid edible fat-water emul- Liquid shortening ...... For household use. sions intended for use as substitutes Pancake mixes ...... for milk or cream in beverage coffee, at Precooked instant rice ...... a level not to exceed 0.3 percent by Pudding mixes ......
87
VerDate 06
(c) They are used in an amount not fatty acids derived from these sub- greater than required to produce the stances (hydrogenated and nonhydro- intended physical or technical effect, genated) meeting the requirements of and they may be used with shortening § 172.860(b) and/or oleic acid derived and edible fats and oils when such are from tall oil fatty acids meeting the required in the foods identified in para- requirements of § 172.862. graph (b) of this section. (b) They are used as emulsifiers in food, in amounts not greater than that § 172.850 Lactylated fatty acid esters of glycerol and propylene glycol. required to produce the intended phys- ical or technical effect. The food additive lactylated fatty (c) Polyglycerol esters of a mixture acid esters of glycerol and propylene glycol may be safely used in food in ac- of stearic, oleic, and coconut fatty cordance with the following prescribed acids are used as a cloud inhibitor in conditions: vegetable and salad oils when use is (a) The additive is a mixture of esters not precluded by standards of identity. produced by the lactylation of a prod- The fatty acids used in the production uct obtained by reacting edible fats or of the polyglycerol esters meet the re- oils with propylene glycol. quirements of § 172.860(b), and the (b) The additive meets the following polyglycerol esters are used at a level specifications: Water insoluble com- not in excess of the amount required to bined lactic acid, 14–18 percent; and perform its cloud-inhibiting effect. acid number, 12 maximum. Oleic acid derived from tall oil fatty (c) It is used in amounts not in excess acids conforming with § 172.862 may be of that reasonably required to produce used as a substitute for or together the intended physical effect as an with the oleic acid permitted by this emulsifier, plasticizer, or surface-ac- paragraph. tive agent in food. (d) Polyglycerol esters of butter oil fatty acids are used as emulsifiers in § 172.852 Glyceryl-lacto esters of fatty acids. combination with other approved emul- sifiers in dry, whipped topping base. Glyceryl-lacto esters of fatty acids The fatty acids used in the production (the lactic acid esters of mono- and of the polyglycerol esters meet the re- diglycerides) may be safely used in quirements of § 172.860(b), and the food in accordance with the following prescribed conditions: polyglycerol esters are used at a level (a) They are manufactured from glyc- not in excess of the amount required to erin, lactic acid, and fatty acids con- perform their emulsifying effect. forming with § 172.860 and/or oleic acid derived from tall oil fatty acids con- § 172.856 Propylene glycol mono- and diesters of fats and fatty acids. forming with § 172.862 and/or edible fats and oils. Propylene glycol mono- and diesters (b) They are used in amounts not in of fats and fatty acids may be safely excess of those reasonably required to used in food, subject to the following accomplish their intended physical or prescribed conditions: technical effect as emulsifiers and plas- (a) They are produced from edible ticizers in food. fats and/or fatty acids in compliance with § 172.860 and/or oleic acid derived § 172.854 Polyglycerol esters of fatty from tall oil fatty acids in compliance acids. with § 172.862. Polyglycerol esters of fatty acids, up (b) They are used in food in amounts to and including the decaglycerol not in excess of that reasonably re- esters, may be safely used in food in ac- quired to produce their intended effect. cordance with the following prescribed conditions: § 172.858 Propylene glycol alginate. (a) They are prepared from corn oil, cottonseed oil, lard, palm oil from The food additive propylene glycol fruit, peanut oil, safflower oil, sesame alginate (CAS Reg. No. 9005–37–2) may oil, soybean oil, and tallow and the
88
VerDate 06
be used as an emulsifier, flavoring ad- to exceed 1.7 percent by weight of the juvant, formulation aid, stabilizer, sur- finished product. factant, or thickener in foods in ac- (10) As an emulsifier, flavoring adju- cordance with the following prescribed vant, formulation aid, stabilizer or conditions: thickener, or surface active agent in (a) The additive meets the specifica- other foods, where applicable, at a tions of the Food Chemicals Codex, 3d level not to exceed 0.3 percent by Ed. (1981), p. 256, which is incorporated weight of the finished product. by reference (copies are available from (c) To ensure safe use of the additive, the National Academy Press, 2101 Con- the label of the food additive container stitution Ave. NW., Washington, DC shall bear, in addition to the other in- 20418, or available for inspection at the formation required by the act: Office of the Federal Register, 800 (1) The name of the additive, ‘‘pro- North Capitol Street, NW., suite 700, pylene glycol alginate’’ or ‘‘propylene Washington, DC 20408), and the addi- glycol ester of alginic acid’’. tional specification that it shall have (2) Adequate directions for use. up to 85 percent of the carboxylic acid [47 FR 29950, July 9, 1982] groups esterified with the remaining groups either free or neutralized. § 172.859 Sucrose fatty acid esters. (b) The additive is used or intended Sucrose fatty acid esters identified in for use in the following foods as defined this section may be safely used in ac- in § 170.3(n) of this chapter, when stand- cordance with the following prescribed ards of identity established under sec- conditions: tion 401 of the act do not preclude such (a) Sucrose fatty acid esters are the use: mono-, di-, and tri-esters of sucrose (1) As a stabilizer in frozen dairy des- with fatty acids and are derived from serts, in fruit and water ices, and in sucrose and edible tallow or hydro- confections and frostings at a level not genated edible tallow or edible vege- to exceed 0.5 percent by weight of the table oils. The only solvents which finished product. may be used in the preparation of su- (2) As an emulsifier, flavoring adju- crose fatty acid esters are those gen- vant, stabilizer, or thickener in baked erally recognized as safe in food or reg- goods at a level not to exceed 0.5 per- ulated for such use by an appropriate cent by weight of the finished product. section in this part. Ethyl acetate or (3) As an emulsifier, stabilizer, or methyl ethyl ketone or dimethyl sulf- thickener in cheeses at a level not to oxide and isobutyl alcohol (2-methyl-1- exceed 0.9 percent by weight of the fin- propanol) may be used in the prepara- ished product. tion of sucrose fatty acid esters. (4) As an emulsifier, stabilizer, or (b) Sucrose fatty acid esters meet the thickener in fats and oils at a level not following specifications: to exceed 1.1 percent by weight of the (1) The total content of mono-, di-, finished product. and tri-esters is not less than 80 per- (5) As an emulsifier, stabilizer, or cent as determined by a method title thickener in gelatins and puddings at a ‘‘Sucrose Fatty Acid Esters, Method of level not to exceed 0.6 percent by Assay,’’ which is incorporated by ref- weight of the finished product. erence. Copies are available from the (6) As a stabilizer or thickener in gra- Center for Food Safety and Applied Nu- vies and in sweet sauces at a level not trition (HFS–200), Food and Drug Ad- to exceed 0.5 percent by weight of the ministration, 200 C St. SW., Wash- finished product. 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
89
VerDate 06
reference is given in paragraph (b)(1) of and Drug Administration, 200 C St. this section. SW., Washington, DC 20204, or available (3) The acid value is not more than 6. for inspection at the Office of the Fed- (4) The residue on ignition (sulfated eral Register, 800 North Capitol Street, ash) is not more than 2 percent. NW., suite 700, Washington, DC 20408. (5) The total ethyl acetate content is (c) Sucrose fatty acid esters may be not more than 350 parts per million as used as follows when standards of iden- determined by a method titled ‘‘Deter- tity established under section 401 of mination of Ethyl Acetate,’’ which is the Federal Food, Drug, and Cosmetic incorporated by reference. Copies are Act do not preclude such use: available from the Center for Food (1) As emulsifiers as defined in Safety and Applied Nutrition (HFS– § 170.3(o)(8) of this chapter, or as stabi- 200), Food and Drug Administration, lizers as defined in § 170.3(o)(28) of this 200 C St. SW., Washington, DC 20204, or chapter, in baked goods and baking available for inspection at the Office of mixes as defined in § 170.3(n)(1) of this 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
90
VerDate 06
acids and their associated fatty acids for chick-edema shall be the method manufactured from fats and oils de- described in the ‘‘Journal of the Asso- rived from edible sources: Capric acid, ciation of Official Analytical Chem- caprylic acid, lauric acid, myristic ists,’’ Volume 50 (No. 1), pages 216–218 acid, oleic acid, palmitic acid, and ste- (1967), or the modified method using a aric acid. sulfuric acid clean-up procedure, as de- (b) The food additive meets the fol- scribed in the ‘‘Journal of the Associa- lowing specifications: tion of the Offical Analytical Chem- (1) Unsaponifiable matter does not ists,’’ Volume 51 (No. 2), pages 489–490 exceed 2 percent. (1968), which are incorporated by ref- (2) It is free of chick-edema factor: erence. See paragraph (c)(2) of this sec- (i) As evidenced during the bioassay tion for availability of these ref- method for determining the chick- erences. edema factor as prescribed in para- (d) It is used or intended for use as graph (c)(2) of this section; or follows: (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- nent as the name of the acid. termined by the method described in the 13th Ed. (1980) of the ‘‘Official [42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, Methods of Analysis of the Association 1984; 54 FR 24897, June 12, 1989] of Official Analytical Chemists,’’ which is incorporated by reference. Copies are § 172.861 Cocoa butter substitute from available from the Association of Offi- coconut oil, palm kernel oil, or both cial Analytical Chemists International, oils. 481 North Frederick Ave., suite 500, The food additive, cocoa butter sub- Gaithersburg, MD 20877–2504, or avail- stitute from coconut oil, palm kernel able for inspection at the Office of the oil, or both oils, may be safely used in Federal Register, 800 North Capitol food in accordance with the following Street, NW., suite 700, Washington, DC conditions: 20408. (a) Cocoa butter substitute from co- (2) Chick-edema factor shall be deter- conut oil, palm kernel oil (CAS Reg. mined by the bioassay method de- No. 85665–33–4), or both oils is a mixture scribed in ‘‘Official Methods of Anal- of triglycerides. It is manufactured by ysis of the Association of Official Ana- esterification of glycerol with food- lytical Chemists,’’ 13th Ed. (1980), sec- grade fatty acids (complying with tions 28.127–28.130, which is incor- § 172.860) derived from edible coconut porated by reference. Copies may be oil, edible palm kernel oil, or both oils. obtained from the Association of Offi- (b) The ingredient meets the fol- cial Analytical Chemists International, lowing specifications: 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877–2504, or may be Acid number: Not to exceed 0.5. examined at the Office of the Federal Saponification number: 220 to 260. Register, 800 North Capitol Street, Iodine number: Not to exceed 3. ° NW., suite 700, Washington, DC 20408. Melting range: 30 to 44 C. (3) The gas chromatographic-electron (c) The ingredient is used or intended capture method for testing fatty acids for use as follows:
91
VerDate 06
(1) As coating material for sugar, (3) The requirements for absence of table salt, vitamins, citric acid, suc- chick-edema factor as prescribed in cinic acid, and spices; and § 172.860. (2) In compound coatings, cocoa (c) It is used or intended for use as creams, cocoa-based sweets, toffees, follows: caramel masses, and chewing sweets as (1) In foods as a lubricant, binder, defined in § 170.3 (n)(9) and (n)(38) of and defoaming agent in accordance this chapter, except that the ingredient with good manufacturing practice. may not be used in a standardized food (2) As a component in the manufac- unless permitted by the standard of ture of other food-grade additives. identity. (d) To assure safe use of the additive, (d) The ingredient is used in accord- the label and labeling of the additive ance with current good manufacturing and any premix thereof shall bear, in 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 [56 FR 66970, Dec. 27, 1991; 57 FR 2814, Jan. 23, acid. 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. The food additive oleic acid derived [42 FR 14491, Mar. 15, 1977, as amended at 49 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 accordance with the following pre- The food additive salts of fatty acids scribed conditions: may be safely used in food and in the (a) The additive consists of purified manufacture of food components in ac- oleic acid separated from refined tall cordance with the following prescribed oil fatty acids. conditions: (b) The additive meets the following (a) The additive consists of one or specifications: any mixture of two or more of the alu- (1) Specifications for oleic acid pre- minum, calcium, magnesium, potas- scribed in the ‘‘Food Chemicals sium, and sodium salts of the fatty Codex.’’ 3d Ed. (1981), pp. 207–208, which acids conforming with § 172.860 and/or is incorporated by reference, except oleic acid derived from tall oil fatty that titer (solidification point) shall acids conforming with § 172.862. not exceed 13.5 °C and unsaponifiable (b) The food additive is used or in- matter shall not exceed 0.5 percent. tended for use as a binder, emulsifier, Copies of the material incorporated by and anticaking agent in food in accord- reference may be obtained from the ance with good manufacturing prac- National Academy Press, 2101 Constitu- tice. tion Ave. NW., Washington, DC 20418, (c) To assure safe use of the additive, or may be examined at the Office of the the label and labeling of the additive Federal Register, 800 North Capitol and any premix thereof shall bear, in Street, NW., suite 700, Washington, DC addition to the other information re- 20408. quired by the Act, the following: (2) The resin acid content does not (1) The common or usual name of the exceed 0.01 as determined by ASTM fatty acid salt or salts contained there- method D1240–82, ‘‘Standard Test Meth- in. od for Rosin Acids in Fatty Acids,’’ (2) The words ‘‘food grade’’, in jux- which is incorporated by reference. taposition with and equally as promi- Copies may be obtained from the Amer- nent as the name of the salt. ican Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or § 172.864 Synthetic fatty alcohols. may be examined at the Office of the Synthetic fatty alcohols may be safe- Federal Register, 800 North Capitol ly used in food and in the synthesis of Street, NW., suite 700, Washington, DC food components in accordance with 20408. the following prescribed conditions:
92
VerDate 06
(a) The food additive consists of any (ii) Ultraviolet absorbance limits as one of the following fatty alcohols: follows: (1) Hexyl, octyl, decyl, lauryl, Maximum myristyl, cetyl, and stearyl; manufac- absorb- tured by fractional distillation of alco- ance per Wavelength (millicrons) centimeter hols obtained by a sequence of oxida- optical tion and hydrolysis of organo-alu- path length minums generated by the controlled re- 280±289 ...... 0.15 action of low molecular weight 290±299 ...... 12 trialkylaluminum with purified ethyl- 300±359 ...... 05 360±400 ...... 02 ene (minimum 99 percent by volume C2H4), and utilizing the hydrocarbon (2) Use ASTM method D86–82, solvent as defined in paragraph (b) of ‘‘Standard Method for Distillation of this section, such that: Petroleum Products,’’ which is incor- (i) Hexyl, octyl, decyl, lauryl, and porated by reference, to determine myristyl alcohols contain not less than boiling point range. Copies of the ma- 99 percent of total alcohols and not less terial incorporated by reference may than 96 percent of straight chain alco- be obtained from the American Society hols. Any nonalcoholic impurities are for Testing Materials, 1916 Race St., primarily paraffins. Philadelphia, PA 19103, or may be ex- (ii) Cetyl and stearyl alcohols con- amined at the Office of the Federal tain not less than 98 percent of total Register, 800 North Capitol Street, alcohols and not less than 94 percent of NW., suite 700, Washington, DC 20408. straight chain alcohols. Any non- (3) The analytical method for deter- alcoholic impurities are primarily mining ultraviolet absorbance limits is paraffins. as follows: (iii) The synthetic fatty alcohols con- tain no more than 0.1 weight percent of GENERAL INSTRUCTIONS total diols as determined by a method All glassware should be scrupulously available upon request from the Com- cleaned to remove all organic matter such as missioner of Food and Drugs. oil, grease, detergent residues, etc. Examine 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 minums generated by the controlled re- to avoid contamination of hydrocarbon sol- action of low molecular weight vent samples in handling and to assure ab- 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 (a)(1) of this section is a mixture of liq- length (packing section), inside diameter 19 millimeters ±1 millimeter, equipped with a uid hydrocarbons essentially paraffinic 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. Stainless steel rod. 2 feet in length, 2 to 4 (1) The hydrocarbon solvent meets millimeters in diameter. the following specifications: Vacuum oven. Similar to Labline No. 3610 (i) Boiling-point range: 175 °C–275 °C. but modified as follows: A copper tube one-
93
VerDate 06
fourth inch in diameter and 13 inches in To the specified quantity of solvent in a length is bent to a right angle at the 4-inch 250-milliliter beaker, add 1 milliliter of puri- point and plugged at the opposite end; eight fied n-hexadecane and evaporate in the vacu- copper tubes one-eighth inch in diameter and um oven under a stream of nitrogen. Dis- 5 inches in length are silver soldered in continue evaporation when not over 1 milli- drilled holes (one-eighth inch in diameter) to liter of residue remains. (To the residue from the one-fourth-inch tube, one on each side at benzene add a 5-milliliter portion of purified the 5-, 7.5-, 10- and 12.5-inch points; the one- isooctane, reevaporate, and repeat once to eighth-inch copper tubes are bent to conform insure complete removal of benzene.) with the inner periphery of the oven. Dissolve the 1 milliliter of hexadecane res- Beakers. 250-milliliter and 500-milliliter ca- idue in isooctane and make to 5 milliliters pacity. volume. Determine the absorbance in the 1- Graduated cylinders. 25-milliliter, 50-milli- centimeter path length cells compared to liter, and 150-milliliter capacity. isooctane as reference. The absorbance of the Tuberculin syringe. 1-milliliter capacity, solution of the solvent residue shall not ex- with 3-inch, 22-gauge needle. ceed 0.02 per centimeter path length between µ Volumetric flask. 5-milliliter capacity. 280 and 300 m and shall not exceed 0.01 per Spectrophotometric cells. Fused quartz centimeter path length between 300 and 400 mµ. ground glass stoppered cells, optical path Isooctane (2,2,4-trimethylpentane). Use 10 length in the range of 1.000 centimeter ±0.005 milliliters for the test described in the pre- centimeter. With distilled water in the cells, ceding paragraph. If necessary, isooctane determine any absorbance difference. may be purified by passage through a column Spectrophotometer. Spectral range 250 milli- of activated silica gel (Grade 12, Davison microns—400 millimicrons with spectral slit Chemical Co., Baltimore, Md., or equiva- width of 2 millimicrons or less: under instru- lent). ment operating conditions for these absorb- Benzene, spectro grade (Burdick and Jackson ance measurements, the spectrophotometer Laboratories, Inc., Muskegon, Mich., or equiva- shall also meet the following performance lent). Use 80 milliliters for the test. If nec- requirements: essary, benzene may be purified by distilla- ± Absorbance repeatability, 0.01 at 0.4 ab- tion or otherwise. sorbance. Hexane, spectro grade (Burdick and Jackson Absorbance accuracy,1 ±0.05 at 0.4 absorb- Laboratories, Inc., Muskegon, Mich., or equiva- ance. lent). Use 650 milliliters for the test. If nec- Wavelength repeatability, ±0.2 milli- 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- ume with hexane, with mixing. n-Hexadecane, 99 percent olefin-free. Dilute 1 As determined by using potassium chro- 1.0 milliliter of n-hexadecane to 5 milliliters mate for reference standard and described in with isooctane and determine the absorbance National Bureau of Standards Circular 484, in a 1-centimeter cell compared to isooctane Spectrophotometry, U.S. Department of as reference between 280 mµ-400mµ. The ab- Commerce, (1949). The accuracy is to be de- sorbance per centimeter path length shall termined by comparison with the standard not exceed 0.00 in this range. If necessary, n- values at 290, 345, and 400 millimicrons. Cir- hexadecane may be purified by percolation cular 484 is incorporated by reference. Copies through activated silica gel or by distilla- are available from the Center for Food Safe- tion. ty and Applied Nutrition (HFS–200), Food Silica gel, 28–200 mesh (Grade 12, Davison and Drug Administration, 200 C St. SW., Chemical Co., Baltimore, Md., or equivalent). Washington, DC 20204, or available for in- Activate as follows: Weigh about 900 grams spection at the Office of the Federal Reg- into a 1-gallon bottle, add 100 milliliters of ister, 800 North Capitol Street, NW., suite de-ionized water, seal the bottle and shake 700, Washington, DC 20408. and roll at intervals for 1 hour. Allow to
94
VerDate 06
equilibrate overnight in the sealed bottle. liliters of 40 percent benzene for a total of 200 Activate the gel at 150 °C for 16 hours, in a milliliters. Evaporate the benzene in the 2-inch × 7-inch × 12-inch porcelain pan loose- oven with vacuum and sufficient nitrogen ly covered with aluminum foil, cool in a flow to just ripple the top of the benzene so- dessicator, transfer to a bottle and seal. lution. When the benzene is removed (as de- termined by a constant volume of hexa- PROCEDURE decane) add 5 milliliters of isooctane and Determination of ultraviolet absorbance. Be- evaporate. Repeat once to insure complete fore proceeding with the analysis of a sample removal of benzene. Remove the beaker and determine the absorbance in a 1-centimeter cover with aluminum foil (previously rinsed path cell for the reagent blank by carrying with hexane) until cool. out the procedure without a sample. Record Quantitatively transfer the hexadecane the absorbance in the wavelength range of residue to a 5-milliliter volumetric flask and 280 to 400 millimicrons. Typical reagent dilute to volume with isooctane. Determine blank absorbance in this range should not the absorbance of the solution in 1-centi- exceed 0.04 in the 280 to 299 millimicron meter path length cells between 280 and 400 range, 0.02 in the 300 to 359 millimicron millimicrons using isooctane as a reference. range, and 0.01 in the 360 to 400 millimicron Correct the absorbance values for any ab- range. If the characteristic benzene peaks in sorbance derived from reagents as deter- the 250 to 260 millimicron region are present, mined by carrying out the procedure without remove the benzene by the procedure de- a sample. If the corrected absorbance does scribed above under ‘‘Reagents and Mate- not exceed the limits prescribed in para- rials,’’ ‘‘Organic Solvents,’’ and record ab- graph (b)(1)(ii) of this section, the sample sorbance again. meets the ultraviolet absorbance specifica- Transfer 50 grams of silica gel to the tions for hydrocarbon solvent. 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 gel. Pour 100 milliliters of hexane into the (1) As substitutes for the cor- column with the stopcock open and allow to responding naturally derived fatty al- drain to about one-half inch above the gel. cohols permitted in food by existing Turn off the stopcock and allow the column regulations in this part or part 173 of 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. Weigh out 40 grams ±0.1 gram of the hydro- responding naturally derived fatty al- carbon solvent sample into a 250-milliliter cohols used as intermediates in the beaker, add 50 milliliters of hexane, and pour synthesis of food additives and other 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 with 50-milliliter portions of hexane. Allow § 172.866 Synthetic glycerin produced each hexane rinse to separately elute to by the hydrogenolysis of carbo- about one-half inch above the gel. Replace hydrates. 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 10 percent 1,2-dichloroethane for a total of (a) It shall contain not in excess 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:
95
VerDate 06
(a) Olestra is a mixture of octa-, cent as determined by a method enti- hepta-, and hexa-esters of sucrose with tled ‘‘Measurement of the Fatty Acid fatty acids derived from edible fats and Composition of Olestra Test Material,’’ oils or fatty acid sources that are gen- dated December 19, 1995, which is incor- erally recognized as safe or approved porated by reference in accordance for use as food ingredients. The chain with 5 U.S.C. 552(a) and 1 CFR part 51. lengths of the fatty acids are no less Copies are available from the Office of than 12 carbon atoms. Premarket Approval, Center for Food (b) Olestra meets the following speci- Safety and Applied Nutrition (HFS– fications: 200), Food and Drug Administration, (1) The total content of octa-, hepta- 200 C St. SW., Washington, DC, or may , and hexa-esters is not less than 97 per- be examined at the Center for Food cent as determined by a method enti- Safety and Applied Nutrition’s Li- tled ‘‘Determination of Olestra by Size brary, 200 C St. SW., rm. 3321, Wash- Exclusion Chromatography,’’ dated De- ington, DC, or at the Office of the Fed- cember 19, 1995, which is incorporated eral Register, 800 North Capitol Street, by reference in accordance with 5 NW., suite 700, Washington, DC. U.S.C. 552(a) and 1 CFR part 51. Copies (6) The content of C12 and C14 fatty are available from the Office of Pre- acids is each not more than 1 percent, market Approval, Center for Food and total C20 and longer fatty acids is Safety and Applied Nutrition (HFS– not more than 20 percent. C16 and C18 200), Food and Drug Administration, fatty acids make up the remainder 200 C St. SW., Washington, DC, or may with total content not less than 78 per- be examined at the Center for Food cent as determined by the method list- Safety and Applied Nutrition’s Li- ed in paragraph (b)(5) of this section. brary, 200 C St. SW., rm. 3321, Wash- (7) The free fatty acid content is not ington, DC, or at the Office of the Fed- more than 0.5 percent as determined by eral Register, 800 North Capitol Street, a method entitled ‘‘Free Fatty Acids’’ NW., suite 700, Washington, DC. published in the Official Methods and (2) The content of octa-ester is not Recommended Practices of the American less than 70 percent as determined by a Oil Chemists’ Society, 3d Ed. (1985) vol. 1, method entitled ‘‘Measurement of the which is incorporated by reference in Relative Ester Distribution of Olestra accordance with 5 U.S.C. 552(a) and 1 Test Material’’ dated December 19, CFR part 51. Copies are available from 1995, which is incorporated by reference the American Oil Chemists Society, in accordance with 5 U.S.C. 552(a) and 1 1608 Broadmoor Dr., Champaign, IL CFR part 51. Copies are available from 61821, or may be examined at the Cen- the Office of Premarket Approval, Cen- ter for Food Safety and Applied Nutri- ter for Food Safety and Applied Nutri- tion’s Library, 200 C St. SW., rm. 3321, tion (HFS–200), Food and Drug Admin- Washington, DC, or at the Office of the istration, 200 C St. SW., Washington, Federal Register, 800 North Capitol DC, or may be examined at the Center Street, NW., suite 700, Washington, DC. for Food Safety and Applied Nutri- (8) The residue on ignition (sulfated tion’s Library, 200 C St. SW., rm. 3321, ash) is not more than 0.5 percent. Washington, DC, or at the Office of the (9) Total methanol content is not Federal Register, 800 North Capitol more than 300 parts per million as de- Street, NW., suite 700, Washington, DC. termined by the ‘‘Total Available (3) The content of hexa-ester is not Methanol Method,’’ dated December 19, more than 1 percent as determined by 1995, which is incorporated by reference the method listed in paragraph (b)(2) of in accordance with 5 U.S.C. 552(a) and 1 this section. CFR part 51. Copies are available from (4) The content of penta-ester is not the Office of Premarket Approval, Cen- more than 0.5 percent as determined by ter for Food Safety and Applied Nutri- the method listed in paragraph (b)(2) of tion (HFS–200), Food and Drug Admin- this section. istration, 200 C St. SW., Washington, (5) The unsaturated fatty acid con- DC or may be examined at the Center tent is not less than 25 percent (thus for Food Safety and Applied Nutri- not more than 75 percent saturated tion’s Library, 200 C St. SW., rm. 3321, fatty acid) and not more than 83 per- Washington, DC, or at the Office of the
96
VerDate 06
Federal Register, 800 North Capitol December 19, 1995, which is incor- Street, NW., suite 700, Washington, DC. porated by reference in accordance (10) The total heavy metal content with 5 U.S.C. 552(a) and 1 CFR part 51. (as Pb) is not more than 10 parts per Copies are available from the Office of million. Premarket Approval, Center for Food (11) Lead is not more than 0.1 part Safety and Applied Nutrition (HFS– per million, as determined by a method 200), Food and Drug Administration, entitled ‘‘Atomic Absorption 200 C St. SW., Washington, DC, or may Spectrophotometric Graphite Furnace be examined at the Center for Food Method,’’ Food Chemicals Codex, 3d Ed. Safety and Applied Nutrition’s Li- 3d Supp. p. 168 (1992), which is incor- brary, 200 C St. SW., rm. 3321, Wash- porated by reference in accordance ington, DC, or at the Office of the Fed- with 5 U.S.C. 552(a) and 1 CFR part 51. eral Register, 800 North Capitol St. Copies are available from the National NW., suite 700, Washington, DC. Research Council Press, 2101 Constitu- (c) Olestra may be used in place of tion Ave. NW., Washington, DC, or may fats and oils in prepackaged ready-to- be examined at the Center for Food eat savory (i.e., salty or piquant but Safety and Applied Nutrition’s Li- not sweet) snacks. In such foods, the brary, 200 C St. SW., rm. 3321, Wash- additive may be used in place of fats ington, DC, or at the Office of the Fed- and oils for frying or baking, in dough eral Register, 800 North Capitol Street, conditioners, in sprays, in filling ingre- NW., suite 700, Washington, DC. dients, or in flavors. (12) Water is not more than 0.1 per- cent, as determined by a method enti- (d) To compensate for any inter- tled ‘‘Moisture,’’ Official Methods and ference with absorption of fat soluble Recommended Practices of the American vitamins, the following vitamins shall Oil Chemists’ Society, 4th Ed. (1989), vol. be added to foods containing olestra: 1, which is incorporated by reference in 1.9 milligrams alpha-tocopherol equiva- accordance with 5 U.S.C. 552(a) and 1 lents per gram olestra; 51 retinol CFR part 51. Copies are available from equivalents per gram olestra (as the American Oil Chemists Society, retinyl acetate or retinyl palmitate); 12 µ 1608 Broadmoor Dr., Champaign, IL IU vitamin D per gram olestra; and 8 g 61821, or may be examined at the Cen- vitamin K1 per gram olestra. ter for Food Safety and Applied Nutri- (e)(1) The label of a food containing tion’s Library, 200 C St. SW., rm. 3321, olestra shall bear the following state- Washington, DC, or at the Office of the ment in the manner prescribed in para- Federal Register, 800 North Capitol graph (e)(2) of this section: Street, NW., suite 700, Washington, DC. THIS PRODUCT CONTAINS OLESTRA. Olestra (13) Peroxide value is not more than may cause abdominal cramping and loose 10 meq/kg as determined by a method stools. Olestra inhibits the absorption of entitled ‘‘Peroxide Value,’’ Official some vitamins and other nutrients. Vitamins Methods and Recommended Practices of A, D, E, and K have been added. the American Oil Chemists’ Society, 4th (2) The statement required by para- Ed. (1989) vol. 1, which is incorporated graph (e)(1) of this section shall: by reference in accordance with 5 (i) Appear either on the principal dis- U.S.C. 552(a) and 1 CFR part 51. Copies play panel or on the information panel are available from the American Oil Chemists Society, 1608 Broadmoor Dr., of the label; Champaign, IL 61821, or may be exam- (ii) Be enclosed by a 0.5 point box ined at the Center for Food Safety and rule with 2.5 points of space around the Applied Nutrition’s Library, 200 C St. statement. SW., rm. 3321, Washington, DC, or at (iii) Utilize at least one point lead- the Office of the Federal Register, 800 ing; North Capitol Street, NW., suite 700, (iv) Have type that is kerned so the Washington, DC. letters do not touch; (14) The stiffness is not less than 50 (v) Be all black or one color type, kiloPascals/second, as determined by a printed on a white or other neutral method entitled ‘‘Method for Measure- contrasting background whenever pos- ment of the Stiffness of Olestra,’’ dated sible;
97
VerDate 06
(vi) Utilize a single easy-to-read type (3) The sentence ‘‘This Product Con- style such as Helvetica Regular and tains Olestra.’’ shall be highlighted by upper and lower case letters; and bold or extra bold type, such as (vii) Be in type size no smaller than Helvetica Black. The label shall appear 8 point. as follows:
(4) Vitamins A, D, E, and K present in tiate any appropriate regulatory pro- foods as a result of the requirement in ceedings. paragraph (d) of this section shall be [61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, declared in the listing of ingredients. 1996] Such vitamins shall not be considered in determining nutrient content for the § 172.868 Ethyl cellulose. nutritional label or for any nutrient The food additive ethyl cellulose may claims, express or implied. be safely used in food in accordance (5) Olestra shall not be considered as with the following prescribed condi- a source of fat or calories for purposes tions: of §§ 101.9 and 101.13 of this chapter. (a) The food additive is a cellulose (f) Consistent with its obligation to ether containing ethoxy (OC2H5) groups monitor the safety of all additives in attached by an ether linkage and con- the food supply, including olestra, the taining on an anhydrous basis not more Food and Drug Administration will re- than 2.6 ethoxy groups per view and evaluate all data and infor- anhydroglucose unit. mation bearing on the safety of olestra (b) It is used or intended for use as received by the agency after the effec- follows: tive date of this regulation, and will (1) As a binder and filler in dry vita- min preparations. present such data, information, and (2) As a component of protective evaluation to the agency’s Food Advi- coatings for vitamin and mineral tab- sory Committee within 30 months of lets. the effective date of this regulation. (3) As a fixative in flavoring com- The purpose of such presentation will pounds. be to receive advice from the Com- mittee on whether there continues to § 172.870 Hydroxypropyl cellulose. be reasonable certainty that use of The food additive hydroxypropyl cel- olestra in compliance with this regula- lulose may be safely used in food, ex- tion is not harmful. The agency will cept standardized foods that do not hold such additional Food Advisory provide for such use, in accordance Committee meetings on olestra as the with the following prescribed condi- agency determines, in its discretion, to tions: be necessary. Based upon the results of (a) The additive consists of one of the this entire process, the FDA will ini- following:
98
VerDate 06
(1) A cellulose ether containing pro- (2) The viscosity of an aqueous solu- pylene glycol groups attached by an tion, 2.5 grams of the material in 100 ether linkage which contains, on an an- milliliters of water, at 20 °C, is 20 to 60 hydrous basis, not more than 4.6 centipoises. hydroxypropyl groups per (3) The ash content on a dry basis has anhydroglucose unit. The additive has a maximum of 0.6 percent. a minimum viscosity of 145 centipoises (c) The food additive is used as an for 10 percent by weight aqueous solu- aerating, emulsifying, and foaming tion at 25 °C. agent, in an amount not in excess of (2) A cellulose ether containing pro- that reasonably required to produce its pylene glycol groups attached by an intended effect. ether linkage having a hydroxypropoxy (OC3H6OH) content of 5 to 16 percent § 172.874 Hydroxypropyl weight in weight (w/w) on an anhydrous methylcellulose. basis, i.e., 0.1 to 0.4 hydroxypropyl The food additive hydroxypropyl groups per anhydroglucose unit. The methylcellulose (CAS Reg. No. 9004–65– common name for this form of the ad- 3) may be safely used in food, except in ditive is low substituted hydroxypropyl standardized foods which do not pro- cellulose. vide for such use if: (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- graph (a)(1) of this section is used or in the National Formulary, 12th edi- intended for use as an emulsifier, film tion. former, protective colloid, stabilizer, (b) It is used or intended for use as an suspending agent, or thickener, in ac- emulsifier, film former, protective col- cordance with good manufacturing loid, stabilizer, suspending agent, or practice. thickener, in accordance with good (2) The additive identified in para- manufacturing practice. graph (a)(2) of this section is used or (c) To insure safe use of the additive, intended for use as a binder and dis- the container of the additive, in addi- integrator in tablets or wafers con- tion to being labeled as required by the taining dietary supplements of vita- general provisions of the act, shall be mins and/or minerals. The additive is accompanied by labeling which con- used in accordance with good manufac- tains adequate directions for use to turing practice. provide a final product that complies with the limitations prescribed in para- [46 FR 50065, Oct. 9, 1981] graph (b) of this section. § 172.872 Methyl ethyl cellulose. [42 FR 14491, Mar. 15, 1977, as amended at 47 The food additive methyl ethyl cel- FR 38273, Aug. 31, 1982] lulose may be safely used in food in ac- cordance with the following prescribed § 172.876 Castor oil. conditions. The food additive castor oil may be (a) The additive is a cellulose ether safely used in accordance with the fol- having the general formula [C6H(10–x– lowing conditions: y)O5(CH3)x(C2H5)y]n, where x is the num- (a) The additive meets the specifica- ber of methyl groups and y is the num- tions of the United States Pharma- ber of ethyl groups. The average value copeia XX (1980). of x is 0.3 and the average value of y is (b) The additive is used or intended 0.7. for use as follows: (b) The additive meets the following specifications: Use and Limitations (1) The methoxy content shall be not Hard candy production—As a release agent less than 3.5 percent and not more than and antisticking agent, not to exceed 500 6.5 percent, calculated as OCH3, and the parts per million in hard candy. ethoxy content shall be not less than Vitamin and mineral tablets—As a compo- 14.5 percent and not more than 19 per- nent of protective coatings. cent, calculated as OC2H5, both meas- [42 FR 14491, Mar. 15, 1977, as amended at 49 ured on the dry sample. FR 10105, Mar. 19, 1984]
99
VerDate 06
§ 172.878 White mineral oil. corporated by reference, after correc- White mineral oil may be safely used tion of the ultraviolet absorbance for in food in accordance with the fol- any absorbance due to added anti- lowing conditions: oxidants. Copies of the material incor- (a) White mineral oil is a mixture of porated by reference are available from liquid hydrocarbons, essentially par- the Center for Food Safety and Applied affinic and naphthenic in nature ob- Nutrition (HFS–200), Food and Drug tained from petroleum. It is refined to Administration, 200 C St. SW., Wash- meet the following specifications: ington, DC 20204, or available for in- (1) It meets the test requirements of spection at the Office of the Federal the United States Pharmacopeia XX Register, 800 North Capitol Street, (1980) for readily carbonizable sub- NW., suite 700, Washington, DC 20408. stances (page 532). (b) White mineral oil may contain (2) It meets the test requirements of any antioxidant permitted in food by U.S.P. XVII for sulfur compounds (page regulations issued in accordance with 400). section 409 of the Act, in an amount (3) It meets the specifications pre- not greater than that required to scribed in the ‘‘Journal of the Associa- produce its intended effect. tion of Official Analytical Chemists,’’ (c) White mineral oil is used or in- Volume 45, page 66 (1962), which is in- 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. (a) Petrolatum complies with the specifications set forth in the United Petrolatum may be safely used in States Pharmacopeia XX (1980) for food, subject to the provisions of this section.
100
VerDate 06
white petrolatum or in the National Millimicrons Maximum Formulary XV (1980) for petrolatum. (b) Petrolatum meets the following 280±289 ...... 0.25 ultraviolet absorbance limits when 290±299 ...... 20 300±359 ...... 14 subjected to the analytical procedure 360±400 ...... 04 described in § 172.886(b): Ultraviolet absorbance per centimeter (c) Petrolatum is used or intended for path length: use as follows:
Limitation (inclusive of all petroleum hydrocarbons Use that may be used in combination with petrolatum)
In bakery products; as release agent and lubricant ...... With white mineral oil, not to exceed 0.15 percent of bakery product. In confectionery; as release agent and as sealing and polishing agent ... Not to exceed 0.2 percent of confectionery. In dehydrated fruits and vegetables; as release agent ...... Not to exceed 0.02 percent of dehydrated fruits and vegetables. In egg white solids; as release agent ...... Not to exceed 0.1 percent of egg white solids. On raw fruits and vegetables; as protective coating ...... In an amount not to exceed good manufacturing prac- tice. In beet sugar and yeast; as defoaming agent ...... As prescribed in § 173.340 of this chapter.
(d) Petrolatum may contain any shall be determined by the procedure de- antioxidant permitted in food by regu- scribed for application of mineral oil, dis- lations issued in accordance with sec- regarding the last sentence of the procedure, tion 409 of the Act, in an amount not under ‘‘Specifications’’ on page 66 of the greater than that required to produce ‘‘Journal of the Association of Official Ana- its intended effect. lytical Chemists,’’ Volume 45 (February 1962), which is incorporated by reference. [42 FR 14491, Mar. 15, 1977, as amended at 49 Copies are available from the Center for FR 10105, Mar. 19, 1984] Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 200 C St. § 172.882 Synthetic isoparaffinic petro- SW., Washington, DC 20204, or available for leum hydrocarbons. inspection at the Office of the Federal Reg- Synthetic isoparaffinic petroleum ister, 800 North Capitol Street, NW., suite hydrocarbons may be safely used in 700, Washington, DC 20408. For hydrocarbons food, in accordance with the following boiling below 250 °F, the nonvolatile residue conditions: shall be determined by ASTM method D1353– (a) They are produced by synthesis 78, ‘‘Standard Test Method for Nonvolatile Matter in Volatile Solvents for Use in Paint, from petroleum gases and consist of a Varnish, Lacquer, and Related Products;’’ mixture of liquid hydrocarbons meet- for those boiling above 121 °C, ASTM method ing the following specifications: D381–80, ‘‘Standard Test Method for Existent Boiling point 93–260 °C as determined by Gum in Fuels by Jet Evaporation’’ shall be ASTM method D86–82, ‘‘Standard Method for used. These methods are incorporated by ref- Distillation of Petroleum Products,’’ which erence. Copies may be obtained from the is incorporated by reference. Copies may be American Society for Testing Materials, 1916 obtained from the American Society for Race St., Philadelphia, PA 19103, or may be Testing Materials, 1916 Race St., Philadel- examined at the Office of the Federal Reg- phia, PA 19103, or may be examined at the ister, 800 North Capitol Street, NW., suite Office of the Federal Register, 800 North Cap- 700, Washington, DC 20408. itol Street, NW., suite 700, Washington, DC 20408. (b) Isoparaffinic petroleum hydro- Ultraviolet absorbance: carbons may contain antioxidants au- 260–319 millimicrons—1.5 maximum. thorized for use in food in an amount 320–329 millimicrons—0.08 maximum. not to exceed that reasonably required 330–350 millimicrons—0.05 maximum. Nonvolatile residual: 0.002 gram per 100 to accomplish the intended technical milliliters maximum. effect nor to exceed any prescribed lim- Synthetic isoparaffinic petroleum hydro- itations. carbons containing antioxidants shall meet (c) Synthetic isoparaffinic petroleum the specified ultraviolet absorbance limits hydrocarbons are used or intended for after correction for any absorbance due to use as follows: the antioxidants. The ultraviolet absorbance
101
VerDate 06
Uses Limitations Use Limitations
1. In the froth-flotation cleaning of In an amount not to ex- As a float on fermentation fluids in In an amount not to ex- vegetables. ceed good manufac- the manufacture of vinegar and ceed good manufac- turing practice. wine to prevent or retard ac- turing practice. 2. As a component of insecticide Do. cess of air, evaporation, and formulations for use on proc- wild yeast contamination during essed foods. fermentation. 3. As a component of coatings on Do. In the froth-flotation cleaning of Do. fruits and vegetables. vegetables. 4. As a coating on shell eggs ...... Do. As a component of insecticide for- Do. 5. As a float on fermentation Do. mulations used in compliance fluids in the manufacture of vin- with regulations issued in parts egar and wine and on brine 170 through 189 of this chapter. used in curing pickles, to pre- vent or retard access of air, evaporation, and contamination § 172.886 Petroleum wax. with wild organisms during fer- mentation. Petroleum wax may be safely used in or on food, in accordance with the fol- [42 FR 14491, Mar. 15, 1977, as amended at 47 lowing conditions: FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, (a) Petroleum wax is a mixture of 1984; 54 FR 24897, June 12, 1989] solid hydrocarbons, paraffinic in na- ture, derived from petroleum, and re- § 172.884 Odorless light petroleum hy- fined to meet the specifications pre- drocarbons. scribed by this section. Odorless light petroleum hydro- (b) Petroleum wax meets the fol- carbons may be safely used in food, in lowing ultraviolet absorbance limits accordance with the following pre- when subjected to the analytical proce- scribed conditions: dure described in this paragraph. (a) The additive is a mixture of liquid hydrocarbons derived from petroleum Maximum or synthesized from petroleum gases. ultraviolet absorb- The additive is chiefly paraffinic, ance per isoparaffinic, or naphthenic in nature. centimeter path length (b) The additive meets the following specifications: 280±289 millimicrons ...... 0.15 (1) Odor is faint and not kerosenic. 290±299 millimicrons ...... 0.12 (2) Initial boiling point is 300 °F min- 300±359 millimicrons ...... 0.08 imum. 360±400 millimicrons ...... 0.02 (3) Final boiling point is 650 °F max- imum. ANALYTICAL SPECIFICATION FOR PETROLEUM (4) Ultraviolet absorbance limits de- WAX termined by method specified in GENERAL INSTRUCTIONS § 178.3620(b)(1)(ii) of this chapter, as fol- lows: Because of the sensitivity of the test, the possibility of errors arising from contamina- Maximum tion is great. It is of the greatest importance absorb- that all glassware be scrupulously cleaned to µ ance per remove all organic matter such as oil, Wavelength m centimeter optical grease, detergent residues, etc. Examine all pathlength glassware, including stoppers and stopcocks, under ultraviolet light to detect any residual 280±289 ...... 4.0 fluorescent contamination. As a pre- 290±299 ...... 3.3 300±329 ...... 2.3 cautionary measure it is recommended prac- 330±360 ...... 8 tice to rinse all glassware with purified iso- octane immediately before use. No grease is (c) The additive is used as follows: to be used on stopcocks or joints. Great care to avoid contamination of wax samples in Use Limitations handling and to assure absence of any extra- neous material arising from inadequate As a coating on shell eggs ...... In an amount not to ex- packaging is essential. Because some of the ceed good manufac- polynuclear hydrocarbons sought in this test turing practice. As a defoamer in processing beet Complying with are very susceptible to photo-oxidation, the sugar and yeast. § 173.340 of this chap- entire procedure is to be carried out under ter. subdued light.
102
VerDate 06
APPARATUS Absorbance accuracy, 1 ±0.05 at 0.4 absorb- ance. Separatory funnels. 250–milliliter, 500–milli- Wavelength repeatability, ±0.2 milli- liter, 1,000–milliliter, and preferably 2,000– micron. milliliter capacity, equipped with tetra- Wavelength accuracy, ±1.0 millimicron. fluoroethylene polymer stopcocks. Nitrogen cylinder. Water-pumped or equiva- Reservoir. 500–milliliter capacity, equipped lent purity nitrogen in cylinder equipped with a 24/40 standard taper male fitting at with regulator and valve to control flow at 5 the bottom and a suitable ball-joint at the p.s.i.g. top for connecting to the nitrogen supply. The male fitting should be equipped with REAGENTS AND MATERIALS glass hooks. Organic solvents. All solvents used through- Chromatographic tube. 180 millimeters in out the procedure shall meet the specifica- length, inside diameter to be 15.7 millimeters tions and tests described in this specifica- ± 0.1 millimeter, equipped with a coarse, frit- tion. The isooctane, benzene, acetone, and ted-glass disc, a tetrafluoroethylene polymer methyl alcohol designated in the list fol- stopcock, and a female 24/40 standard tapered lowing this paragraph shall pass the fol- fitting at the opposite end. (Overall length of lowing test: the column with the female joint is 235 milli- To the specified quantity of solvent in a meters.) The female fitting should be 250–milliliter Erlenmeyer flask, add 1 milli- equipped with glass hooks. liter of purified n-hexadecane and evaporate Disc. Tetrafluoroethylene polymer 2–inch on the steam bath under a stream of nitro- diameter disc approximately 3⁄16–inch thick gen (a) loose aluminum foil jacket around with a hole bored in the center to closely fit the flask will speed evaporation). Dis- the stem of the chromatographic tube. continue evaporation when not over 1 milli- Heating jacket. Conical, for 500–milliliter liter of residue remains. (To the residue from separatory funnel. (Used with variable trans- benzene add a 10–milliliter portion of puri- former heat control.) fied isooctane, reevaporate, and repeat once Suction flask. 250–milliliter or 500–milliliter to insure complete removal of benzene.) filter flask. Alternatively, the evaporation time can be Condenser. 24/40 joints, fitted with a drying reduced by using the optional evaporation tube, length optional. flask. In this case the solvent and n-hexa- Evaporation flask (optional). 250–milliliter decane are placed in the flask on the steam or 500–milliliter capacity all-glass flask bath, the tube assembly is inserted, and a equipped with standard taper stopper having stream of nitrogen is fed through the inlet inlet and outlet tubes to permit passage of tube while the outlet tube is connected to a solvent trap and vacuum line in such a way nitrogen across the surface of contained liq- as to prevent any flow-back of condensate uid to be evaporated. into the flask. Vacuum distillation assembly. All glass (for Dissolve the 1 milliliter of hexadecane res- purification of dimethyl sulfoxide); 2–liter idue in isooctane and make to 25 milliliters distillation flask with heating mantle; volume. Determine the absorbance in the 5– Vigreaux vacuum-jacketed condenser (or centimeter path length cells compared to equivalent) about 45 centimeters in length isooctane as reference. The absorbance of the and distilling head with separable cold finger solution of the solvent residue (except for condenser. Use of tetrafluoroethylene poly- methyl alcohol) shall not exceed 0.01 per cen- mer sleeves on the glass joints will prevent timeter path length between 280 and 400 mµ. freezing. Do not use grease on stopcocks or For methyl alcohol this absorbance value joints. shall be 0.00. Spectrophotometric cells. Fused quartz cells, optical path length in the range of 5.000 cen- timeters ±0.005 centimeter; also for checking 1 As determined by using potassium chro- spectrophotometer performance only, optical mate for reference standard and described in path length in the range 1.000 centimeter National Bureau of Standards Circular 484, ±0.005 centimeter. With distilled water in the Spectrophotometry, U.S. Department of cells, determine any absorbance differences. Commerce, (1949). The accuracy is to be de- termined by comparison with the standard Spectrophotometer. Spectral range 250 milli- values at 290, 345, and 400 millimicrons. Cir- microns–400 millimicrons with spectral slit cular 484 is incorporated by reference. Copies width of 2 millimicrons or less, under instru- are available from the Center for Food Safe- ment operating conditions for these absorb- ty and Applied Nutrition (HFS–200), Food ance measurements, the spectrophotometer and Drug Administration, 200 C St. SW., shall also meet the following performance Washington, DC 20204, or available for in- requirements: spection at the Office of the Federal Reg- Absorbance repeatability, ±0.01 at 0.4 ab- ister, 800 North Capitol Street, NW., suite sorbance. 700, Washington, DC 20408.
103
VerDate 06
Isooctane (2,2,4–trimethylpentane). Use 180 Add 1 milliliter of n-hexadecane and evapo- milliliters for the test described in the pre- rate the isooctane on the steam bath under ceding paragraph. Purify, if necessary, by nitrogen. Discontinue evaporation when not passage through a column of activated silica over 1 milliliter of residue remains. To the gel (Grade 12, Davison Chemical Company, residue, add a 10–milliliter portion of iso- Baltimore, Maryland, or equivalent) about 90 octane and reevaporate to 1 milliliter of centimeters in length and 5 centimeters to 8 hexadecane. Again, add 10 milliliters of iso- centimeters in diameter. octane to the residue and evaporate to 1 mil- Benzene, A.C.S. reagent grade. Use 150 milli- liliter of hexadecane to insure complete re- liters for the test. Purify, if necessary, by moval of all volatile materials. Dissolve the distillation or otherwise. 1 milliliter of hexadecane in isooctane and Acetone, A.C.S. reagent grade. Use 200 milli- make to 25–milliliter volume. Determine the liters for the test. Purify, if necessary, by reference. The absorbance of the solution distillation. should not exceed 0.02 per centimeter path Eluting mixtures: length in the 280 mµ–400 mµ range. (NOTE.— 1. 10 percent benzene in isooctane. Pipet 50 Difficulty in meeting this absorbance speci- milliliters of benzene into a 500–milliliter fication may be due to organic impurities in glass-stoppered volumetric flask and adjust the distilled water. Repetition of the test to volume with isooctane, with mixing. omitting the dimethyl sulfoxide will disclose 2. 20 percent benzene in isooctane. Pipet 50 their presence. If necessary to meet the spec- milliliters of benzene into a 250–milliliter ification, purify the water by redistillation, glass-stoppered volumetric flask, and adjust passage through an ion-exchange resin, or to volume with isooctane, with mixing. otherwise.) 3. Acetone-benzene-water mixture. Add 20 Purify, if necessary, by the following pro- milliliters of water to 380 milliliters of ace- cedure: To 1,500 milliliters of dimethyl sulf- tone and 200 milliliters of benzene, and mix. oxide in a 2–liter glass-stoppered flask, add n-Hexadecane, 99 percent olefin-free. Dilute 6.0 milliliters of phosphoric acid and 50 1.0 milliliter of n-hexadecane to 25 milliliters grams of Norit A (decolorizing carbon, alka- with isooctane and determine the absorbance line) or equivalent. Stopper the flask, and in a 5–centimeter cell compared to isooctane with the use of a magnetic stirrer (tetra- as reference point between 280 mµ–400 mµ. fluoroethylene polymer coated bar) stir the The absorbance per centimeter path length solvent for 15 minutes. Filter the dimethyl shall not exceed 0.00 in this range. Purify, if sulfoxide through four thicknesses of fluted 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- Sodium borohydride. 98 percent. ally into the evaporating flask. Wash the Magnesium oxide (Sea Sorb 43, Food Machin- first separatory funnel with the second 40– ery Company, Westvaco Division, distributed by milliliter isooctane extractive, and pass chemical supply firms, or equivalent). Place 100 through the sodium sulfate into the flask. grams of the magnesium oxide in a large Then wash the second and first separatory beaker, add 700 milliliters of distilled water funnels successively with a 10–milliliter por- to make a thin slurry, and heat on a steam tion of isooctane, and pass the solvent bath for 30 minutes with intermittent stir- through the sodium sulfate into the flask. ring. Stir well initially to insure that all the
104
VerDate 06
absorbent is completely wetted. Using a Place 300 milliliters of dimethyl sulfoxide Buchner funnel and a filter paper (Schleicher in a 1–liter separatory funnel and add 75 mil- & Schuell No. 597, or equivalent) of suitable liliters of phosphoric acid. Mix the contents diameter, filter with suction. Continue suc- of the funnel and allow to stand for 10 min- tion until water no longer drips from the utes. (The reaction between the sulfoxide funnel. Transfer the absorbent to a glass and the acid is exothermic. Release pressure trough lined with aluminum foil (free from after mixing, then keep funnel stoppered.) rolling oil). Break up the magnesia with a Add 150 milliliters of isooctane and shake to clean spatula and spread out the absorbent preequilibrate the solvents. Draw off the in- on the aluminum foil in a layer about 1 cen- dividual layers and store in glass-stoppered timeter to 2 centimeters thick. Dry for 24 flasks. hours at 160 °C ±1 °C. Pulverize the magnesia Place a representative 1–kilogram sample with mortar and pestle. Sieve the pulverized of wax, or if this amount is not available, the absorbent between 60–180 mesh. Use the mag- entire sample, in a beaker of a capacity nesia retained on the 180–mesh sieve. about three times the volume of the sample Celite 545. Johns-Manville Company, diato- and heat with occasional stirring on a steam maceous earth, or equivalent. bath until the wax is completely melted and Magnesium oxide-Celite 545 mixture (2+ 1) by homogeneous. Weigh four 25–gram ±0.2 gram weight. Place the magnesium oxide (60–180 portions of the melted wax in separate 100– mesh) and the Celite 545 in 2 to 1 propor- milliliter beakers. Reserve three of the por- tions, respectively, by weight in a glass- tions for later replicate analyses as nec- stoppered flask large enough for adequate essary. Pour one weighed portion imme- mixing. Shake vigorously for 10 minutes. diately after remelting (on the steam bath) Transfer the mixture to a glass trough lined into a 500–milliliter separatory funnel con- with aluminum foil (free from rolling oil) taining 100 milliliters of the preequilibrated and spread it out on a layer about 1 centi- sulfoxide-phosphoric acid mixture that has meter to 2 centimeters thick. Reheat the been heated in the heating jacket at a tem- mixture at 160 °C ±1 °C for 2 hours, and store perature just high enough to keep the wax in a tightly closed flask. melted. (NOTE: In preheating the sulfoxide- Sodium sulfate, anhydrous, A.C.S. reagent acid mixture, remove the stopper of the sepa- grade, preferably in granular form. For each ratory funnel at intervals to release the bottle of sodium sulfate reagent used, estab- pressure.) lish as follows the necessary sodium sulfate Promptly complete the transfer of the prewash to provide such filters required in sample to the funnel in the jacket with por- the method: Place approximately 35 grams of tions of the preequilibrated isooctane, warm- anhydrous sodium sulfate in a 30–milliliter ing the beaker, if necessary, and using a coarse, fritted-glass funnel or in a 65–milli- total volume of just 50 milliliters of the sol- meter filter funnel with glass wool plug; vent. If the wax comes out of solution during wash with successive 15–milliliter portions of these operations, let the stoppered funnel re- the indicated solvent until a 15–milliliter main in the jacket until the wax redissolves. portion of the wash shows 0.00 absorbance (Remove stopper from the funnel at intervals per centimeter path length between 280 mµ to release pressure.) When the wax is in solu- and 400 mµ when tested as prescribed under tion, remove the funnel from the jacket and ‘‘Organic solvents.’’ Usually three portions shake it vigorously for 2 minutes. Set up of wash solvent are sufficient. three 250–milliliter separatory funnels with Before proceeding with analysis of a sam- each containing 30 milliliters of ple, determine the absorbance in a 5–centi- preequilibrated isooctane. After separation meter path cell between 250 mµ and 400 mµ of the liquid phases, allow to cool until the for the reagent blank by carrying out the main portion of the wax-isooctane solution procedure, without a wax sample, at room begins to show a precipitate. Gently swirl temperature, recording the spectra after the the funnel when precipitation first occurs on extraction stage and after the complete pro- the inside surface of the funnel to accelerate cedure as prescribed. The absorbance per this process. Carefully draw off the lower centimeter path length following the extrac- layer, filter it slowly through a thin layer of tion stage should not exceed 0.040 in the glass wool fitted loosely in a filter funnel wavelength range from 280 mµ to 400 mµ; the into the first 250–milliliter separatory fun- absorbance per centimeter path length fol- nel, and wash in tandem with the 30–milli- lowing the complete procedure should not liter portions of isooctane contained in the exceed 0.070 in the wavelength range from 280 250–milliliter separatory funnels. Shaking mµ to 299 mµ, inclusive, nor 0.045 in the time for each wash is 1 minute. Repeat the wavelength range from 300 mµ to 400 mµ. If in extraction operation with two additional either spectrum the characteristic benzene portions of the sulfoxide-acid mixture, re- peaks in the 250 mµ–260 mµ region are placing the funnel in the jacket after each present, remove the benzene by the proce- extraction to keep the wax in solution and dure under ‘‘Organic solvents’’ and record washing each extractive in tandem through absorbance again. the same three portions of isooctane.
105
VerDate 06
Collect the successive extractives (300 mil- intermittent swirling. At the end of this pe- liliters total) in a separatory funnel (pref- riod, disconnect the flask and evaporate the erably 2–liter), containing 480 milliliters of methyl alcohol on the steam bath under ni- distilled water, mix, and allow to cool for a trogen until the sodium borohydride begins few minutes after the last extractive has to come out of the solution. Then add 10 mil- been added. Add 80 milliliters of isooctane to liliters of isooctane and evaporate to a vol- the solution and extract by shaking the fun- ume of about 2–3 milliliters. Again, add 10 nel vigorously for 2 minutes. Draw off the milliliters of isooctane and concentrate to a lower aqueous layer into a second separatory volume of approximately 5 milliliters. Swirl funnel (preferably 2–liter) and repeat the ex- the flask repeatedly to assure adequate traction with 80 milliliters of isooctane. washing of the sodium borohydride residues. Draw off and discard the aqueous layer. Fit the tetrafluoroethylene polymer disc Wash each of the 80–milliliter extractives on the upper part of the stem of the three times with 100–milliliter portions of chromatographic tube, then place the tube distilled water. Shaking time for each wash with the disc on the suction flask and apply is 1 minute. Discard the aqueous layers. Fil- the vacuum (approximately 135 millimeters ter the first extractive through anhydrous Hg pressure). Weight out 14 grams of the 2:1 sodium sulfate prewashed with isooctane (see magnesium oxide-Celite 545 mixture and Sodium Sulfate under ‘‘Reagents and Mate- pour the adsorbent mixture into the rials’’ for preparation of filter) into a 250– chromatographic tube in approximately 3– milliliter Erlenmeyer flask (or optionally centimeter layers. After the addition of each into the evaporation flask). Wash the first layer, level off the top of the adsorbent with separatory funnel with the second 80–milli- a flat glass rod or metal plunger by pressing liter isooctane extractive and pass through down firmly until the adsorbent is well the sodium sulfate. Then wash the second packed. Loosen the topmost few millimeters and first separatory funnels successively of each adsorbent layer with the end of a with a 20–milliliter portion of isooctane and metal rod before the addition ofthe next 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
106
VerDate 06
all this solvent mixture has been removed alkylacrylate monomer content not in from the column. Discard all the elution sol- excess of 14 percent, as determined by a vents collected up to this point. Add 300 mil- method entitled, ‘‘Method for Deter- liliters of the acetone-benzene-water mixture to the reservoir and percolate through the mining Weight-Average and Number- column to elute the polynuclear compounds. Average Molecular Weight and for De- Collect the eluate in a clean 1–liter sepa- termining Alkylacrylate Monomer ratory funnel. Allow the column to drain Content of Poly(alkylacrylate) used as until most of the solvent mixture is re- Processing Aid in Manufacture of Pe- moved. Wash the eluate three times with troleum Wax,’’ which is incorporated 300–milliliter portions of distilled water, by reference (copies are available from shaking well for each wash. (The addition of the Center for Food Safety and Applied small amounts of sodium chloride facilitates separation.) Discard the aqueous layer after Nutrition (HFS–200), 200 C St. SW., each wash. After the final separation, filter Washington, DC 20204, or available for the residual benzene through anhydrous so- inspection at the Office of the Federal dium sulfate prewashed with benzene (see So- Register, 800 North Capitol Street, dium sulfate under ‘‘Reagents and Materials’’ NW., suite 700, Washington, DC 20408). for preparation of filter) into a 250–milliliter Petroleum wax shall contain not more Erlenmeyer flask (or optionally into the than 1,050 parts per million of evaporation flask). Wash the separatory fun- poly(alkylacrylate) residues as deter- nel with two additional 20–milliliter portions of benzene which are also filtered through mined by a method entitled, ‘‘Method the sodium sulfate. Add 1 milliliter of n- for Determining Residual Level of hexadecane and completely remove the ben- Poly(alkylacrylate) in Petroleum zene by evaporation under nitrogen, using Wax,’’ which is incorporated by ref- the special procedure to eliminate benzene erence. Copies are available from the as previously described under ‘‘Organic Sol- address cited in this paragraph (c)(2). vents.’’ Quantitatively transfer the residue (d) Petroleum wax is used or intended with isooctane to a 25–milliliter volumetric for use as follows: flask and adjust to volume. Determine the absorbance of the solution in the 5–centi- Use Limitations meter path length cells compared to iso- octane as reference between 250 mµ–400 mµ. In chewing gum base, as a mas- In an amount not to ex- Correct for any absorbance derived from the ticatory substance. ceed good manufac- reagents as determined by carrying out the turing practice. procedure without a wax sample. If either On cheese and raw fruits and Do. spectrum shows the characteristic benzene vegetables as a protective coat- µ µ ing. peaks in the 250 m –260m region, evaporate As a defoamer in food ...... In accordance with the solution to remove benzene by the proce- § 173.340 of this chap- dure under ‘‘Organic Solvents.’’ Dissolve the ter. residue, transfer quantitatively, and adjust As a component of microcapsules In accordance with to volume in isooctane in a 25–milliliter vol- for spice-flavoring substances. § 172.230 of this chap- umetric flask. Record the absorbance again. ter. If the corrected absorbance does not exceed the limits prescribed in this paragraph (b), [42 FR 14491, Mar. 15, 1977, as amended at 45 the wax meets the ultraviolet absorbance FR 48123, July 18, 1980; 47 FR 11838, Mar. 19, specifications. 1982; 50 FR 32561, Aug. 13, 1985; 51 FR 19544, (c) Petroleum wax may contain one May 30, 1986; 54 FR 24897, June 12, 1989] or more of the following adjuvants in amounts not greater than that re- § 172.888 Synthetic petroleum wax. quired to produce their intended effect: Synthetic petroleum wax may be (1) Antioxidants permitted in food by safely used in or on foods in accordance regulations issued in accordance with with the following conditions: section 409 of the act. (a) Synthetic petroleum wax is a (2) Poly(alkylacrylate) (CAS Reg. No. mixture of solid hydrocarbons, par- 27029–57–8), made from long chain (C16– affinic in nature, prepared by either C22) alcohols and acrylic acid, having: catalytic polymerization of ethylene or (i) A number average molecular weight copolymerization of ethylene with lin- between 40,000 and 100,000; (ii) a weight ear (C3 to C12) alpha-olefins, and refined average molecular weight (MWw) to to meet the specifications prescribed in number average molecular weight this section. (MWn) ratio (MWw/MWn) of not less (b) Synthetic petroleum wax meets than 3; and (iii) unreacted the ultraviolet absorbance limits of
107
VerDate 06
§ 172.886(b) when subjected to the ana- safe use of the food starch-modified, lytical procedure described therein. the label of the food additive container (c) Synthetic petroleum wax has a shall bear the name of the additive number average molecular weight of ‘‘food starch-modified’’ in addition to not less than 500 nor greater than 1,200 other information required by the Act. as determined by vapor pressure os- Food starch may be modified by treat- mometry. ment prescribed as follows: (d) Synthetic petroleum wax may (a) Food starch may be acid-modified contain any antioxidant permitted in by treatment with hydrochloric acid or food by regulations issued in accord- sulfuric acid or both. ance with section 409 of the act, in an (b) Food starch may be bleached by amount not greater than that required treatment with one or more of the fol- to produce its intended effect. (e) Synthetic petroleum wax is used lowing: or intended for use as follows: Limitations
Use Limitations Active oxygen obtained from hy- drogen peroxide and/or per- In chewing gum base, as a In accordance with § 172.615 acetic acid, not to exceed 0.45 masticatory substance. in an amount not to exceed percent of active oxygen. good manufacturing prac- Ammonium persulfate, not to ex- tice. ceed 0.075 percent and sulfur On cheese and raw fruits and In an amount not to exceed dioxide, not to exceed 0.05 per- vegetables as a protective good manufacturing prac- cent. coating. tice. As a defoamer in food ...... In accordance with § 173.340 Chlorine, as calcium hypochlorite, The finished food starch- of this chapter. not to exceed 0.036 percent of modified is limited to dry starch. use only as a compo- nent of batter for com- [42 FR 14491, Mar. 15, 1977, as amended at 59 mercially processed FR 10986, Mar. 9, 1994] foods. Chlorine, as sodium hypochlorite, not to exceed 0.0082 pound of § 172.890 Rice bran wax. chlorine per pound of dry starch. Rice bran wax may be safely used in Potassium permanganate, not to Residual manganese food in accordance with the following exceed 0.2 percent. (calculated as Mn), not to exceed 50 parts per conditions: million in food starch- (a) It is the refined wax obtained modified. from rice bran and meets the following Sodium chlorite, not to exceed 0.5 specifications: percent. Melting point 75 °C to 80 °C. (c) Food starch may be oxidized by Free fatty acids, maximum 10 percent. treatment with chlorine, as sodium hy- Iodine number, maximum 20. pochlorite, not to exceed 0.055 pound of Saponification number 75 to 120. chlorine per pound of dry starch. (b) It is used or intended for use as (d) Food starch may be esterified by follows: treatment with one of the following: Food Limitation in food Use Limitations Candy ...... 50 p.p.m ...... Coating. Acetic anhydride ...... Acetyl groups in food Fresh fruits and fresh ...... do ...... Do. starch-modified not to vegetables. exceed 2.5 percent. Chewing gum ...... 21¤2 pct ...... Plasticizing material. Adipic anhydride, not to exceed Do. 0.12 percent, and acetic anhy- dride. § 172.892 Food starch-modified. Monosodium orthophosphate ...... Residual phosphate in food starch-modified Food starch-modified as described in not to exceed 0.4 per- this section may be safely used in food. cent calculated as The quantity of any substance em- phosphorus. ployed to effect such modification shall 1±Octenyl succinic anhydride, not to exceed 3 percent. not exceed the amount reasonably re- 1±Octenyl succinic anhydride, not quired to accomplish the intended to exceed 2 percent, and alu- physical or technical effect, nor exceed minum sulfate, not to exceed 2 any limitation prescribed. To insure percent.
108
VerDate 06
Limitations (g) Food starch may be modified by treatment with one of the following: 1-Octenyl succinic anhydride, not Limited to use as a sta- to exceed 3 percent, followed bilizer or emulsifier in Limitations by treatment with a beta-amy- beverages and bev- lase enzyme that is either an erage bases as de- Chlorine, as sodium hypochlorite, Residual propylene approved food additive of is fined in § 170.3(n)(3) of not to exceed 0.055 pound of chlorohydrin not more generally recognized as safe.. this chapter. chlorine per pound of dry than 5 parts per million Phosphorus oxychloride, not to starch; 0.45 percent of active in food starch-modi- exceed 0.1 percent. oxygen obtained from hydrogen fied. Phosphorus oxychloride, not to Acetyl groups in food peroxide; and propylene oxide, exceed 0.1 percent, followed by starch-modified not to not to exceed 25 percent. either acetic anhydride, not to exceed 2.5 percent. Sodium hydroxide, not to exceed exceed 8 percent, or vinyl ace- 1 percent. tate, not to exceed 7.5 percent. Sodium trimetaphosphate ...... Residual phosphate in (h) Food starch may be modified by a food starch-modified combination of the treatments pre- not to exceed 0.04 percent, calculated as scribed by paragraphs (a), (b), and/or (i) phosphorus. of this section and any one of the Sodium tripolyphosphate and so- Residual phosphate in treatments prescribed by paragraph (c), dium trimetaphosphate. food starch-modified (d), (e), (f), or (g) of this section, sub- not to exceed 0.4 per- cent calculated as ject to any limitations prescribed by phosphorus. the paragraphs named. Succinic anhydride, not to exceed (i) Food starch may be modified by 4 percent. treatment with the following enzyme: Vinyl acetate ...... Acetyl groups in food starch-modified not to Enzyme Limitations exceed 2.5 percent. Alpha-amylase (E.C. 3.2.1.1) ...... The enzyme must be (e) Food starch may be etherified by generally recognized as safe or approved as treatment with one of the following: a food additive for this purpose. The resulting Limitations nonsweet nutritive sac- charide polymer has a Acrolein, not to exceed 0.6 per- dextrose equivalent of cent. less than 20. Epichlorohydrin, not to exceed 0.3 percent. Epichlorohydrin, not to exceed 0.1 Residual propylene [42 FR 14491, Mar. 15, 1977, as amended at 43 percent, and propylene oxide, chlorohydrin not more FR 11697, Mar. 21, 1978; 46 FR 32015, June 19, not to exceed 10 percent, than 5 parts per million 1981; 57 FR 54700, Nov. 20, 1992; 58 FR 21100, added in combination or in any in food starch-modi- Apr. 19, 1993] sequence. fied. Epichlorohydrin, not to exceed 0.1 Do. § 172.894 Modified cottonseed products percent, followed by propylene intended for human consumption. oxide, not to exceed 25 percent. Propylene oxide, not to exceed 25 Do. The food additive modified cotton- percent. seed products may be used for human consumption in accordance with the (f) Food starch may be esterified and following prescribed conditions: etherified by treatment with one of the (a) The additive is derived from: following: (1) Decorticated, partially defatted, cooked, ground cottonseed kernels; or Limitations (2) Decorticated, ground cottonseed Acrolein, not to exceed 0.6 per- Acetyl groups in food kernels, in a process that utilizes n- cent and vinyl acetate, not to starch-modified not to hexane as an extracting solvent in such exceed 7.5 percent. exceed 2.5 percent. a way that no more than 60 parts per Epichlorohydrin, not to exceed 0.3 Acetyl groups in food percent, and acetic anhydride. starch-modified not to million of n-hexane residues and less exceed 2.5 percent. than 1 percent fat by weight remain in Epichlorohydrin, not to exceed 0.3 the finished product; or percent, and succinic anhy- (3) Glandless cottonseed kernels dride, not to exceed 4 percent. roasted to attain a temperature of not Phosphorus oxychloride, not to Residual propylene exceed 0.1 percent, and pro- chlorohydrin not more less than 250 °F in the kernel for not pylene oxide, not to exceed 10 than 5 parts per million less than 5 minutes for use as a snack percent. in food starch-modi- food, or in baked goods, or in soft fied. candy; or
109
VerDate 06
(4) Raw glandless cottonseed kernels cipally of long chain carbohydrates, may be used in hard candy where the not less than 85 percent on a dry solids kernel temperature during cooking basis. The carbohydrate is composed of will exceed 250 °F for not less than 5 glycan and mannan units in approxi- minutes. mately a 2:1 ratio. (b) The additive is prepared to meet (b) The additive meets the following the following specifications: specifications on a dry weight basis: (1) Free gossypol content not to ex- Less than 0.4 part per million (ppm) ar- ceed 450 parts per million. senic, 0.13 ppm cadmium, 0.2 ppm lead, (2) It contains no added arsenic com- 0.05 ppm mercury, 0.09 ppm selenium, pound and therefore may not exceed a and 10 ppm zinc. maximum natural background level of 0.2 part per million total arsenic, cal- (c) The viable microbial content of culated as As. the finished ingredient is: (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 glandless cottonseed kernels’’. section 401 of the Act do not preclude (4) The additive identified in para- such use: graph (a)(4) of this section as ‘‘raw Use Limitations glandless cottonseed kernels for use in cooked hard candy’’. (1) In salad dressings as an emul- Not to exceed a con- (d) The Food and Drug Administra- sifier and emulsifier salt as de- centration of 5 percent fined in § 170.3(o)(8) of this of the finished salad tion and the Environmental Protection chapter, stabilizer and thickener dressing. Agency have determined that glandless as defined in § 170.3(o)(28) of cottonseed kernels permitted for use this chapter, or texturizer as de- fined in § 170.3(o)(32) of this by this section are a distinct com- chapter. modity from glanded cottonseed. (2) In frozen dessert analogs as a In an amount not to ex- stabilizer and thickener as de- ceed good manufac- § 172.896 Dried yeasts. fined in § 170.3(o)(28) of this turing practice. chapter, or texturizer as defined Dried yeast (Saccharomyces cerevisiae in § 170.3(o)(32) of this chapter. and Saccharomyces fragilis) and dried (3) In sour cream analogs as a Do. torula yeast (Candida utilis) may be stabilizer and thickener as de- safely used in food provided the total fined in § 170.3(o)(28) of this chapter, or texturizer as defined folic acid content of the yeast does not in § 170.3(o)(32) of this chapter. exceed 0.04 milligram per gram of yeast (4) In cheese spread analogs as Do. (approximately 0.008 milligram of a stabilizer and thickener as de- pteroyglutamic acid per gram of fined in § 170.3(o)(28) of this chapter, or texturizer as defined yeast). in § 170.3(o)(32) of this chapter. (5) In cheese-flavored and sour Do. § 172.898 Bakers yeast glycan. cream-flavored snack dips as a stabilizer and thickener as de- Bakers yeast glycan may be safely fined in § 170.3(o)(28) of this used in food in accordance with the fol- chapter, or texturizer as defined lowing conditions: in § 170.3(o)(32) of this chapter. (a) Bakers yeast glycan is the comminuted, washed, pasteurized, and (e) The label and labeling of the in- dried cell walls of the yeast, Saccharo- gredient shall bear adequate directions myces cerevisiae. It is composed prin-
110
VerDate 06
to assure that use of the ingredient 173.280 Solvent extraction process for citric complies with this regulation. acid. 173.290 Trichloroethylene. [42 FR 14491, Mar. 15, 1977, as amended at 45 FR 58836, Sept. 5, 1980] Subpart D—Specific Usage Additives 173.300 Chlorine dioxide. PART 173—SECONDARY DIRECT 173.310 Boiler water additives. FOOD ADDITIVES PERMITTED IN 173.315 Chemicals used in washing or to as- FOOD FOR HUMAN CONSUMP- sist in the peeling of fruits and vegeta- bles. TION 173.320 Chemicals for controlling micro- organisms in cane-sugar and beet-sugar Subpart A—Polymer Substances and mills. Polymer Adjuvants for Food Treatment 173.322 Chemicals used in delinting cotton- seed. Sec. 173.325 Acidified sodium chlorite solutions. 173.5 Acrylate-acrylamide resins. 173.340 Defoaming agents. 173.10 Modified polyacrylamide resin. 173.342 Chlorofluorocarbon 113 and 173.20 Ion-exchange membranes. perfluorohexane. 173.21 Perfluorinated ion exchange mem- 173.345 Chloropentafluoroethane. branes. 173.350 Combustion product gas. 173.25 Ion-exchange resins. 173.355 Dichlorodifluoromethane. 173.40 Molecular sieve resins. 173.357 Materials used as fixing agents in 173.45 Polymaleic acid and its sodium salt. the immobilization of enzyme prepara- 173.50 Polyvinylpolypyrrolidone. tions. 173.55 Polyvinylpyrrolidone. 173.360 Octafluorocyclobutane. 173.60 Dimethylamine-epichlorohydrin co- 173.385 Sodium methyl sulfate. polymer. 173.395 Trifluoromethane sulfonic acid. 173.65 Divinylbenzene copolymer. 173.400 Dimethyldialkylammonium chlo- 173.70 Chloromethylated aminated styrene- ride. divinylbenzene resin. 173.73 Sodium polyacrylate. AUTHORITY: 21 U.S.C. 321, 342, 348. 173.75 Sorbitan monooleate. SOURCE: 42 FR 14526, Mar. 15, 1977, unless otherwise noted. Subpart B—Enzyme Preparations and Microorganisms EDITORIAL NOTE: Nomenclature changes to part 173 appear at 61 FR 14482, Apr. 2, 1996. 173.110 Amyloglucosidase derived from Rhizopus niveus. Subpart A—Polymer Substances 173.120 Carbohydrase and cellulase derived from Aspergillus niger. and Polymer Adjuvants for 173.130 Carbohydrase derived from Rhizopus Food Treatment oryzae. 173.135 Catalase derived from Microccocus § 173.5 Acrylate-acrylamide resins. lysodeikticus. Acrylate-acrylamide resins may be 173.140 Esterase-lipase derived from Mucor safely used in food under the following miehei. 173.145 Alpha-Galactosidase derived from prescribed conditions: Mortierella vinaceae var. raffinoseutilizer. (a) The additive consists of one of the 173.150 Milk-clotting enzymes, microbial. following: 173.160 Candida guilliermondii. (1) Acrylamide-acrylic acid resin 173.165 Candida lipolytica. (hydrolyzed polyacrylamide) is pro- 173.170 Aminoglycoside 3′- duced by the polymerization of acryl- phosphotransferase II. amide with partial hydrolysis, or by Subpart C—Solvents, Lubricants, Release copolymerization of acrylamide and Agents and Related Substances acrylic acid, with the greater part of the polymer being composed of acryl- 173.210 Acetone. amide units. 173.220 1,3–Butylene glycol. (2) Sodium polyacrylate-acrylamide 173.228 Ethyl acetate. resin is produced by the polymerization 173.230 Ethylene dichloride. and subsequent hydrolysis of acrylo- 173.240 Isopropyl alcohol. 173.250 Methyl alcohol residues. nitrile in a sodium silicate-sodium hy- 173.255 Methylene chloride. droxide aqueous solution, with the 173.270 Hexane. greater part of the polymer being com- 173.275 Hydrogenated sperm oil. posed of acrylate units.
111
VerDate 06
(b) The additive contains not more base conforming to § 177.1520 of this than 0.05 percent of residual monomer chapter to polymerization with styrene calculated as acrylamide. until the polystyrene phase of the base (c) The additive is used or intended is not less than 16 percent nor more for use as follows: than 30 percent by weight. The base is (1) The additive identified in para- then modified by reaction with graph (a) (1) of this section is used as a chloromethyl methyl ether, and by flocculent in the clarification of beet subsequent amination with trimethyl- sugar juice and liquor or cane sugar amine, dimethylamine, diethylene- juice and liquor or corn starch triamine, or dimethylethanolamine. hydrolyzate in an amount not to ex- (b) The ion-exchange membrane is ceed 5 parts per million by weight of manufactured so as to comply with the the juice or 10 parts per million by following extraction limitations when weight of the liquor or the corn starch subjected to the described procedure: hydrolyzate. Separate square-foot samples of mem- (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 resin. juice to adjust the ratio of citric acid 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 resin is produced by the copolymeriza- Substances identified in paragraph tion of acrylamide with not more than (a) of this section may be safely used as 5–mole percent β-methacrylyloxyethy- ion exchange membranes intended for ltrimethylammonium methyl sulfate. use in the treatment of bulk quantities (b) The modified polyacrylamide of liquid food under the following pre- resin contains not more than 0.05 per- scribed conditions: cent residual acrylamide. (a) Identity. The membrane is a co- (c) The modified polyacrylamide polymer of ethanesulfonyl fluoride, 2- 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
112
VerDate 06
may include substances used in accord- (7) Cross-linked phenol-formaldehyde ance with § 174.5 of this chapter. activated with one or both of the fol- (c) Conditions of use. (1) lowing: Triethylene tetramine and Perfluorinated ion exchange mem- tetraethylenepentamine. branes described in paragraph (a) of (8) Reaction resin of formaldehyde, this section may be used in contact acetone, and tetraethylenepentamine. with all types of liquid foods at tem- (9) Completely hydrolyzed copoly- peratures not exceeding 70° (158 °F). mers of methyl acrylate and (2) Maximum thickness of the copoly- divinylbenzene. mer membrane is 0.007 inch (0.017 centi- (10) Completely hydrolyzed meter). terpolymers of methyl acrylate, (3) Perfluorinated ion exchange mem- divinylbenzene, and acrylonitrile. branes shall be maintained in a sani- (11) Sulfonated terpolymers of sty- tary manner in accordance with cur- rene, divinylbenzene, and acrylonitrile rent good manufacturing practice so as or methyl acrylate. to prevent microbial adulteration of (12) Methyl acrylate-divinylbenzene food. copolymer containing not less than 2 (4) To assure their safe use, percent by weight of divinylbenzene, perfluorinated ionomer membranes aminolyzed with dimethylaminopro- shall be thoroughly cleaned prior to pylamine. their first use in accordance with cur- (13) Methyl acrylate-divinylbenzene rent good manufacturing practice. copolymer containing not less than 3.5 [59 FR 15623, Apr. 4, 1994] percent by weight of divinylbenzene, aminolyzed with dimethylaminopro- § 173.25 Ion-exchange resins. pylamine. Ion-exchange resins may be safely (14) Epichlorohydrin cross-linked used in the treatment of food under the with ammonia. following prescribed conditions: (15) Sulfonated tetrapolymer of sty- (a) The ion-exchange resins are pre- rene, divinylbenzene, acrylonitrile, and pared in appropriate physical form, and methyl acrylate derived from a mix- consist of one or more of the following: ture of monomers containing not more (1) Sulfonated copolymer of styrene than a total of 2 percent by weight of and divinylbenzene. acrylonitrile and methyl acrylate. (2) Sulfonated anthracite coal meet- (16) Methyl acrylate-divinylbenzene- ing the requirements of ASTM method diethylene glycol divinyl ether D388–38, Class I, Group 2, ‘‘Standard terpolymer containing not less than 3.5 Specifications for Classification of Coal percent by weight of divinylbenzene by Rank,’’ which is incorporated by and not more than 0.6 percent by reference. Copies are available from weight of diethylene glycol divinyl University Microfilms International, ether, aminolyzed with dimethyl- 300 N. Zeeb Rd., Ann Arbor, MI 48106, or aminopropylamine. available for inspection at the Office of (17) Styrene-divinylbenzene cross- the Federal Register, 800 North Capitol linked copolymer, first Street, NW., suite 700, Washington, DC chloromethylated then aminated with 20408. dimethylamine and oxidized with hy- (3) Sulfite-modified cross-linked phe- drogen peroxide whereby the resin con- nol-formaldehyde, with modification tains not more than 15 percent by resulting in sulfonic acid groups on weight of vinyl N,N-dimethylbenzyl- side chains. amine-N-oxide and not more than 6.5 (4) Methacrylic acid-divinylbenzene percent by weight of nitrogen. copolymer. (18) Methyl acrylate-divinylbenzene- (5) Cross-linked polystyrene, first diethylene glycol divinyl ether chloromethylated then aminated with terpolymer containing not less than 7 trimethylamine, dimethylamine, di- percent by weight of divinylbenzene ethylenetriamine, or dimethylethanol- and not more than 2.3 percent by amine. weight of diethylene glycol divinyl (6) Diethylenetriamine, triethylene- ether, aminolyzed with dimethyl- tetramine, or tetraethylenepentamine aminopropylamine and quaternized cross-linked with epichlorohydrin. with methyl chloride.
113
VerDate 06
(19) Epichlorohydrin cross-linked change resins in the hydrogen form with ammonia and then quaternized identified in paragraphs (a) (1), (2), and with methyl chloride to contain not (11) of this section; or more than 18 percent strong base ca- (ii) The water is first subjected to pacity by weight of total exchange ca- one of the resins identified in para- pacity [Chemical Abstracts Service graph (a) (12) or (16) of this section and name: Oxirane (chloromethyl)-, poly- is subsequently subjected to treatment mer with ammonia, reaction product through a bed of activated carbon or with chloromethane; CAS Reg. No. one of the strongly acidic cation-ex- 68036–99–7]. change resins in the hydrogen form (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 beds is maintained at 50 °C or less and ion-exchange resin identified in para- the flow rate of the water or food pass- graph (a)(18) of this section is used only ing through the beds is not less than 0.5 in accordance with paragraph (b)(4) of gallon per cubic foot per minute. this section, and the ion-exchange (3) The ion-exchange resin identified resin identified in paragraph (a)(20) of in paragraph (a)(17) of this section is this section is used only in accordance used only for industrial application to with paragraphs (b)(5) and (d) of this treat bulk quantities of aqueous food, section. including potable water, or for treat- (1) The ion-exchange resins identified ment of municipal water supplies, sub- in paragraphs (a) (12) and (16) of this ject to the condition that the tempera- section are used to treat water for use ture of the food or water passing in the manufacture of distilled alco- through the resin bed is maintained at holic beverages, subject to the fol- 25 °C or less and the flow rate of the lowing conditions: food or water passing through the bed (i) The water is subjected to treat- is not less than 2 gallons per cubic foot ment through a mixed bed consisting of per minute. one of the resins identified in para- (4) The ion-exchange resin identified graph (a) (12) or (16) of this section and in paragraph (a)(18) of this section is one of the strongly acidic cation-ex- used to treat aqueous sugar solutions
114
VerDate 06
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 this section, the pH range for the resin ash equals the organic extractives. If shall be no less than 3.5 and no more the organic extractives are greater than 9, and the temperatures of water than 1 part per million of the solvent and food passing through the resin bed used, a blank should be run on the sol- shall not exceed 25 cC. vent and a correction should be made (ii) For resins that comply with the by subtracting the total extractives ob- requirements in paragraph (d)(2)(ii) of tained with the blank from the total this section, the pH range for the resin extractives obtained in the resin test. shall be no less than 2 and no more The solvents used are to be made as than 10, and the temperatures of water follows: and food passing through the resin Distilled water (de-ionized water is distilled). shall not exceed 50 °C. 15 percent ethyl alcohol made by mixing 15 (c) To insure safe use of ion-exchange volumes of absolute ethyl alcohol A.C.S. resins, each ion-exchange resin will be: reagent grade, with 85 volumes of distilled (1) Subjected to pre-use treatment by de-ionized water. the manufacturer and/or the user in ac- 5 percent acetic acid made by mixing 5 parts cordance with the manufacturer’s di- by weight of A.C.S. reagent grade glacial acetic acid with 95 parts by weight of dis- rections prescribed on the label or la- tilled de-ionized water. beling accompanying the resins, to guarantee a food-grade purity of ion- In addition to the organic extractives exchange resins, in accordance with limitation prescribed in this para- good manufacturing practice. graph, the ion-exchange resin identi- (2) Accompanied by label or labeling fied in paragraph (a)(17) of this section, to include directions for use consistent when extracted with each of the named with the intended functional purpose of solvents, distilled water, 50 percent al- the resin. cohol, and 5 percent acetic acid, will be (3) Used in compliance with the label found to result in not more than 7 or labeling required by paragraph (c)(2) parts per million of nitrogen extrac- of this section. tives (calculated as nitrogen) when the (4) Found to result in no more than 1 resin in the free-base form is subjected part per million of organic extractives to the following test immediately be- obtained with each of the named sol- fore each use: Using a separate 1–inch vents, distilled water, 15 percent alco- diameter glass ion-exchange column hol, and 5 percent acetic acid when, for each solvent, prepare each column having been washed and otherwise using 100 milliliters of ready to use ion- treated in accordance with the manu- exchange resin that is to be tested. facturer’s directions for preparing With the bottom outlet closed, fill each them for use with food, the ion-ex- ion-exchange column with one of the change resin is subjected to the fol- three solvents at a temperature of 25 °C lowing test: Using a separate ion-ex- until the solvent level is even with the change column for each solvent, pre- top of the resin bed. Seal each column pare columns using 50 milliliters of the at the top and bottom and store in a ready to use ion-exchange resin that is vertical position at a temperature of 25
115
VerDate 06
°C. After 96 hours, open the top of each (b) The molecular sieve resins are column, drain the solvent into a collec- thoroughly washed with potable water tion vessel, and analyze each drained prior to their first use in contact with solvent and a solvent blank for nitro- food. gen by a standard micro-Kjeldahl (c) Molecular sieve resins are used as method. the gel filtration media in the final pu- (d)(1) The ion-exchange resins identi- rification of partially delactosed whey. fied in paragraphs (a)(1), (a)(2), (a)(11), The gel bed shall be maintained in a and (a)(15) of this section are exempted sanitary manner in accordance with from the acetic acid extraction re- good manufacturing practice so as to quirement of paragraph (c)(4) of this prevent microbial build-up on the bed section. and adulteration of the product. (2) The ion-exchange resin identified in paragraph (a)(20) of this section § 173.45 Polymaleic acid and its so- shall comply either with: dium salt. (i) The extraction requirement in Polymaleic acid (CAS Reg. No. 26099– paragraph (c)(4) of this section by using dilute sulfuric acid, pH 3.5 as a sub- 09–2) and its sodium salt (CAS Reg. No. stitute for acetic acid; or 70247–90–4) may be safely used in food (ii) The extraction requirement in in accordance with the following pre- paragraph (c)(4) of this section by using scribed conditions: reagent grade hydrochloric acid, di- (a) The additives have a weight-aver- luted to pH 2, as a substitute for acetic age molecular weight in the range of acid. The resin shall be found to result 540 to 850 and a number-average molec- in no more than 25 parts per million of ular weight in the range of 520 to 650, organic extractives obtained with each calculated as the acid. Molecular of the following solvents: Distilled weights shall be determined by a meth- water; 15 percent alcohol; and hydro- od entitled ‘‘Determination of Molec- chloric acid, pH 2. Blanks should be run ular Weight Distribution of for each of the solvents, and correc- Poly(Maleic) Acid,’’ March 17, 1992, pro- tions should be made by subtracting duced by Ciba-Geigy, Inc., Seven Sky- the total extractives obtained with the line Dr., Hawthorne, NY 10532–2188, blank from the total extractives ob- which is incorporated by reference in tained in the resin test. accordance with 5 U.S.C. 552(a) and 1 (e) Acrylonitrile copolymers identi- CFR part 51. Copies are available from fied in this section shall comply with the Division of Product Policy, Center the provisions of § 180.22 of this chap- for Food Safety and Applied Nutrition ter. (HFS–205), Food and Drug Administra- [42 FR 14526, Mar. 15, 1977, as amended at 46 tion, 200 C St. SW., Washington, DC FR 40181, Aug. 7, 1981; 46 FR 57033, Nov. 20, 20204, or are available for inspection at 1981; 49 FR 28830, July 17, 1984; 56 FR 16268, the Center for Food Safety and Applied Apr. 22, 1991; 62 FR 7679, Feb. 20, 1997; 64 FR Nutrition’s Library, 200 C St. SW., rm. 14609, Mar. 26, 1999] 3321, Washington, DC, or at the Office of the Federal Register, 800 North Cap- § 173.40 Molecular sieve resins. itol St. NW., suite 700, Washington, DC. Molecular sieve resins may be safely (b) The additives may be used, indi- used in the processing of food under the vidually or together, in the processing following prescribed conditions: of beet sugar juice and liquor or of cane (a) The molecular sieve resins consist sugar juice and liquor to control min- of purified dextran having an average eral scale. molecular weight of 40,000, cross-linked (c) The additives are to be used so with epichlorohydrin in a ratio of 1 that the amount of either or both addi- part of dextran to 10 parts of tives does not exceed 4 parts per mil- epichlorohydrin, to give a stable three lion (calculated as the acid) by weight dimensional structure. The resins have a pore size of 2.0 to 3.0 milliliters per of the beet or cane sugar juice or liquor gram of dry resin (expressed in terms process stream. of water regain), and a particle size of [51 FR 5315, Feb. 13, 1986, as amended at 61 10 to 300 microns. FR 386, Jan. 5, 1996]
116
VerDate 06
§ 173.50 Polyvinylpolypyrrolidone. § 173.55 Polyvinylpyrrolidone. The food additive polyvinylpoly- The food additive polyvinylpyrroli- pyrrolidone may be safely used in ac- done may be safely used in accordance cordance with the following prescribed with the following prescribed condi- conditions: tions: (a) The additive is a homopolymer of (a) The additive is a polymer of puri- purified vinylpyrrolidone catalytically fied vinylpyrrolidone catalytically pro- produced under conditions producing duced, having an average molecular polymerization and cross-linking such that an insoluble polymer is produced. weight of 40,000 and a maximum (b) The food additive is so processed unsaturation of 1 percent, calculated as that when the finished polymer is the monomer, except that the refluxed for 3 hours with water, 5 per- polyvinylpyrrolidone used in beer is cent acetic acid, and 50 percent alco- that having an average molecular hol, no more than 50 parts per million weight of 360,000 and a maximum of extractables is obtained with each unsaturation of 1 percent, calculated as solvent. the monomer. (c) It is used or intended for use as a (b) The additive is used or intended clarifying agent in beverages and vin- for use in foods as follows: egar, followed by removal with filtra- tion.
Food Limitations
Beer ...... As a clarifying agent, at a residual level not to exceed 10 parts per million. Flavor concentrates in tablet form ...... As a tableting adjuvent in an amount not to exceed good manufacturing practice. Nonnutritive sweeteners in concentrated liquid As a stabilizer, bodying agent, and dispersant, in an amount not to exceed form. good manufacturing practice. Nonnutritive sweeteners in tablet form ...... As a tableting adjuvant in an amount not to exceed good manufacturing practice. Vitamin and mineral concentrates in liquid form .... As a stabilizer, bodying agent, and dispersant, in an amount not to exceed good manufacturing practice. Vitamin and mineral concentrates in tablet form .... As a tableting adjuvant in an amount not to exceed good manufacturing practice. Vinegar ...... As a clarifying agent, at a residual level not to exceed 40 parts per million. Wine ...... As a clarifying agent, at a residual level not to exceed 60 parts per million.
§ 173.60 Dimethylamine- imum viscosity of 175 centipoises at 25 epichlorohydrin copolymer. °C as determined by LVT-series Brook- Dimethylamine-epichlorohydrin co- field viscometer using a No. 2 spindle polymer (CAS Reg. No. 25988–97–0) may at 60 RPM (or by another equivalent be safely used in food in accordance method). with the following prescribed condi- (3) The additive contains not more tions: than 1,000 parts per million of 1,3- (a) The food additive is produced by dichloro-2-propanol and not more than copolymerization of dimethylamine 10 parts per million epichlorohydrin. and epichlorohydrin in which not more The epichlorohydrin and 1,3-dichloro-2- than 5 mole-percent of dimethylamine propanol content is determined by an may be replaced by an equimolar analytical method entitled ‘‘The Deter- amount of ethylenediamine, and in mination of Epichlorohydrin and 1,3- which the mole ratio of total amine to Dichloro-2-Propanol in Dimethyl- epichlorohydrin is approximately 1:1. amine-Epichlorohydrin Copolymer,’’ (b) The additive meets the following which is incorporated by reference. specifications: Copies are available from the Center (1) The nitrogen content of the co- for Food Safety and Applied Nutrition polymer is 9.4 to 10.8 weight percent on (HFS–200), Food and Drug Administra- a dry basis. tion, 200 C St. SW., Washington, DC (2) A 50-percent-by-weight aqueous 20204, or available for inspection at the solution of the copolymer has a min- Office of the Federal Register, 800
117
VerDate 06
North Capitol Street, NW., suite 700, purity of the resin at the time of use, Washington, DC 20408. in accordance with current good manu- (4) Heavy metals (as Pb), 2 parts per facturing practice. million maximum. (c) The temperature of the aqueous (5) Arsenic (as As), 2 parts per million food stream contacting the polymer is maximum. maintained at 79.4 °C (175 °F) or less. (c) The food additive is used as a de- (d) The copolymer may be used in colorizing agent and/or flocculant in contact with food only of Types I, II, the clarification of refinery sugar liq- and VI–B (excluding carbonated bev- uors and juices. It is added only at the erages) described in table 1 of para- defecation/clarification stage of sugar graph (c) of § 176.170 of this chapter. liquor refining at a concentration not to exceed 150 parts per million of co- [50 FR 61, Jan. 2, 1985] polymer by weight of sugar solids. (d) To assure safe use of the additive, § 173.70 Chloromethylated aminated the label and labeling of the additive styrene-divinylbenzene resin. shall bear, in addition to other infor- Chloromethylated aminated styrene- mation required by the Act, adequate divinylbenzene copolymer (CAS Reg. directions to assure use in compliance No. 60177–39–1) may be safely used in with paragraph (c) of this section. food in accordance with the following [48 FR 37614, Aug. 19, 1983, as amended at 54 prescribed conditions: FR 24897, June 12, 1989] (a) The additive is an aqueous disper- sion of styrene-divinylbenzene copoly- § 173.65 Divinylbenzene copolymer. mers, first chloromethylated then Divinylbenzene copolymer may be aminated with trimethylamine, having used for the removal of organic sub- an average particle size of not more stances from aqueous foods under the than 2.0 microns. following prescribed conditions: (b) The additive shall contain no (a) The copolymer is prepared in ap- more than 3.0 percent nonvolatile, propriate physical form and is derived soluble extractives when tested as fol- by the polymerization of a grade of lows: One hundred grams of the addi- divinylbenzene which comprises at tive is centrifuged at 17,000 r/min for 2 least 79 weight-percent divinylbenzene, hours. The resulting clear supernatant 15 to 20 weight-percent ethylvinyl- is removed from the compacted solids benzene, and no more than 4 weight- and concentrated to approximately 10 percent nonpolymerizable impurities. grams on a steam bath. The 10-gram (b) In accordance with the manufac- sample is again centrifuged at 17,000 r/ turer’s directions, the copolymer de- min for 2 hours to remove any residual scribed in paragraph (a) of this section insoluble material. The supernatant is subjected to pre-use extraction with from the second centrifugation is then a water soluble alcohol until the level removed from any compacted solids of divinylbenzene in the extract is less and dried to constant residual weight than 50 parts per billion as determined using a steam bath. The percent non- by a method titled, ‘‘The Determina- volatile solubles is obtained by divid- tion of Divinylbenzene in Alcohol Ex- ing the weight of the dried residue by tracts of Amberlite XAD–4,’’ which is the weight of the solids in the original incorporated by reference. Copies of resin dispersion. this method are available from the (c) The additive is used as a decol- Center for Food Safety and Applied Nu- orizing and clarification agent for trition (HFS–200), Food and Drug Ad- treatment of refinery sugar liquors and ministration, 200 C St. SW., Wash- juices at levels not to exceed 500 parts ington, DC 20204, or available for in- of additive solids per million parts of spection at the Office of the Federal sugar solids. Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [50 FR 29209, July 18, 1985] The copolymer is then treated with water according to the manufacturer’s § 173.73 Sodium polyacrylate. recommendation to remove the extrac- Sodium polyacrylate (CAS Reg. No. tion solvent to guarantee a food-grade 9003–04–7) may be safely used in food in
118
VerDate 06
accordance with the following pre- sugar juice and 1.4 parts per million in scribed conditions: sugar liquor. (a) The additive is produced by the [51 FR 11720, Apr. 7, 1986] polymerization of acrylic acid and sub- sequent hydrolysis of the polyacrylic acid with an aqueous sodium hydroxide Subpart B—Enzyme Preparations solution. As determined by a method and Microorganisms entitled ‘‘Determination of Weight Av- § 173.110 Amyloglucosidase derived erage and Number Average Molecular from Rhizopus niveus. Weight of Sodium Polyacrylate’’, which is incorporated by reference in Amyloglucosidase enzyme product, accordance with 5 U.S.C. 552(a), the ad- consisting of enzyme derived from ditive has— Rhizopus niveus, and diatomaceous sili- ca as a carrier, may be safely used in (1) A weight average molecular food in accordance with the following weight of 2,000 to 2,300; and conditions: (2) A weight average molecular (a) Rhizopus niveus is classified as fol- weight to number average molecular lows: Class, Phycomycetes; order, weight ratio of not more than 1.3. Cop- Mucorales; family, Mucoraceae; genus, ies of the method are available from Rhizopus; species, niveus. the Center for Food Safety and Applied (b) The strain of Rhizopus niveus is Nutrition (HFS–200), Food and Drug nonpathogenic and nontoxic in man or Administration, 200 C Street SW., other animals. Washington, DC 20204, or available for (c) The enzyme is produced by a proc- inspection at the Office of the Federal ess which completely removes the or- Register, 800 North Capitol Street, ganism Rhizopus niveus from the NW., suite 700, Washington, DC 20408. amyloglucosidase. (b) The additive is used to control (d) The additive is used or intended mineral scale during the evaporation of for use for degrading gelatinized starch beet sugar juice or cane sugar juice in into constituent sugars, in the produc- the production of sugar in an amount tion of distilled spirits and vinegar. not to exceed 3.6 parts per million by (e) The additive is used at a level not weight of the raw juice. to exceed 0.1 percent by weight of the [53 FR 39456, Oct. 7, 1988; 53 FR 49823, Dec. 9, gelatinized starch. 1988] § 173.120 Carbohydrase and cellulase § 173.75 Sorbitan monooleate. derived from Aspergillus niger. Sorbitan monooleate may be safely Carbohydrase and cellulase enzyme used in accordance with the following preparation derived from Aspergillus prescribed conditions: niger may be safely used in food in ac- cordance with the following prescribed (a) The additive is produced by the conditions: esterification of sorbitol with commer- (a) Aspergillus niger is classified as cial oleic acid. follows: Class, Deuteromycetes; order, (b) It meets the following specifica- Moniliales; family, Moniliaceae; genus, tions: Aspergillus; species, niger. (1) Saponification number, 145–160. (b) The strain of Aspergillus niger is (2) Hydroxyl number, 193–210. nonpathogenic and nontoxic in man or (c) The additive is used or intended other animals. for use as follows: (c) The additive is produced by a (1) As an emulsifier in polymer dis- process that completely removes the persions that are used in the clarifica- organism Aspergillus niger from the tion of cane or beet sugar juice or liq- carbohydrase and cellulase enzyme uor in an amount not to exceed 7.5 per- product. cent by weight in the final polymer dis- (d) The additive is used or intended persion. for use as follows: (2) The additive is used in an amount (1) For removal of visceral mass (bel- not to exceed 0.70 part per million in lies) in clam processing.
119
VerDate 06
(2) As an aid in the removal of the § 173.140 Esterase-lipase derived from shell from the edible tissue in shrimp Mucor miehei. processing. Esterase-lipase enzyme, consisting of (e) The additive is used in an amount enzyme derived from Mucor miehei var. not in excess of the minimum required Cooney et Emerson by a pure culture fer- to produce its intended effect. mentation process, with maltodextrin or sweet whey as a carrier, may be § 173.130 Carbohydrase derived from safely used in food in accordance with Rhizopus oryzae. the following conditions: Carbohydrase from Rhizopus oryzae (a) Mucor miehei var. Cooney et Emer- may be safely used in the production of son is classified as follows: Class, dextrose from starch in accordance Phycomycetes; subclass, Zygomycetes; with the following prescribed condi- order, Mucorales; family, Mucoraceae; tions: genus, Mucor; species, miehei; variety (a) Rhizopus oryzae is classified as fol- Cooney et Emerson. lows: Class, Phycomycetes; order, (b) The strain of Mucor miehei var. Mucorales; family, Mucoraceae; genus, Cooney et Emerson is nonpathogenic and Rhizopus; species, Rhizopus oryzae. nontoxic in man or other animals. (b) The strain of Rhizopus oryzae is (c) The enzyme is produced by a proc- nonpathogenic and nontoxic. ess which completely removes the or- (c) The carbohydrase is produced ganism Mucor miehei var. Cooney et under controlled conditions to main- Emerson from the esterase-lipase. tain nonpathogenicity and nontoxicity, (d) The enzyme is used as a flavor including the absence of aflatoxin. enhancer as defined in § 170.3(o)(12). (d) The carbohydrase is produced by a (e) The enzyme is used at levels not process which completely removes the to exceed current good manufacturing organism Rhizopus oryzae from the practice in the following food cat- carbohydrase product. egories: cheeses as defined in (e) The carbohydrase is maintained § 170.3(n)(5) of this chapter; fat and oils as defined in § 170.(3)(n)(12) of this chap- under refrigeration from production to ter; and milk products as defined in use and is labeled to include the neces- § 170.(3)(n)(31) of this chapter. Use of sity of refrigerated storage. this food ingredient is limited to § 173.135 Catalase derived from Micro- nonstandarized foods and those foods coccus lysodeikticus. for which the relevant standards of identity permit such use. Bacterial catalase derived from (f) The enzyme is used in the min- Micrococcus lysodeikticus by a pure cul- imum amount required to produce its ture fermentation process may be safe- limited technical effect. ly used in destroying and removing hy- drogen peroxide used in the manufac- [47 FR 28090, June 29, 1982; 48 FR 2748, Jan. 21, ture of cheese, in accordance with the 1983] following conditions. § 173.145 Alpha-Galactosidase derived (a) The organism Micrococcus from Mortierella vinaceae var. lysodeikticus from which the bacterial raffinoseutilizer. catalase is to be derived is dem- The food additive alpha-galactosidase onstrated to be nontoxic and nonpatho- and parent mycelial microorganism genic. Mortierella vinaceae var. raffinoseutilizer (b) The organism Micrococcus may be safely used in food in accord- lysodeikticus is removed from the bac- ance with the following conditions: terial catalase prior to use of the bac- (a) The food additive is the enzyme terial catalase. alpha-galactosidase and the mycelia of (c) The bacterial catalase is used in the microorganism Mortierella vinaceae an amount not in excess of the min- var. raffinoseutilizer which produces the imum required to produce its intended enzyme. effect. (b) The nonpathogenic microorga- nism matches American Type Culture
120
VerDate 06
Collection (ATCC) No. 20034,1 and is Rhizomucor miehei var. Cooney et Emer- classified as follows: 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. oryzae. Variety: raffinoseutilizer. (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 enzyme removal is such that (d) The additive is used in an amount there are no enzyme or mycelial resi- not in excess of the minimum required dues remaining in the finished sucrose. to produce its intended effect in the production of those cheeses for which [42 FR 14526, Mar. 15, 1977, as amended at 54 it is permitted by standards of identity FR 24897, June 12, 1989] established pursuant to section 401 of § 173.150 Milk-clotting enzymes, micro- the Act. bial. [42 FR 14526, Mar. 15, 1977; 42 FR 56728, Oct. Milk-clotting enzyme produced by 28, 1977, as amended at 62 FR 59284, Nov. 3, pure-culture fermentation process may 1997] be safely used in the production of cheese in accordance with the fol- § 173.160 Candida guilliermondii. lowing prescribed conditions: The food additive Candida (a) Milk-clotting enzyme is derived guilliermondii may be safely used as the from one of the following organisms by organism for fermentation production a pure-culture fermentation process: of citric acid in accordance with the (1) Endothia parasitica classified as following conditions: follows: Class, Ascomycetes; order, (a) The food additive is the enzyme Sphaeriales; family, Diaporthacesae; system of the viable organism Candida genus, Endothia; species, parasitica. guilliermondii and its concomitant me- (2) Bacillus cereus classified as fol- tabolites produced during the fer- lows: Class, Schizomycetes; order, mentation process. Eubacteriales; family, Bacillaceae; (b)(1) The nonpathogenic and genus, Bacillus; species, cereus nontoxicogenic organism descending (Frankland and Frankland). from strain, American Type Culture (3) Mucor pusillus Lindt classified as Collection (ATCC) No. 20474,1 is classi- follows: Class, Phycomycetes; subclass, fied as follows: Zygomycetes; order, Mucorales; fam- Class: Deuteromycetes. ily, Mucoraceae; genus, Mucor; species, Order: Moniliales. pusillus; variety, Lindt. Family: Cryptococcaceae. (4) Mucor miehei Cooney et Emerson Genus: Candida. classified as follows: Class, Species: guilliermondii. Phycomycetes; subclass, Zygomycetes; Variety: guilliermondii. order, Mucorales; family, Mucoraceae; (2) The toxonomic characteristics of genus, Mucor; species, miehei; variety, the reference culture strain ATCC No. Cooney et Emerson. 20474 agree in the essentials with the (5) Aspergillus oryzae modified by re- standard description for Candida combinant deoxyribonucleic (DNA) guilliermondii variety guilliermondii list- techniques to contain the gene coding ed in ‘‘The Yeasts—A Toxonomic for aspartic proteinase from Study;’’ 2d Ed. (1970), by Jacomina
1 Available from: American Type Culture 1 Available from: American Type Culture Collection, 12301 Parklawn Drive, Rockville, Collection, 12301 Parklawn Drive, Rockville, MD 20852. MD 20852.
121
VerDate 06
Lodder, which is incorporated by ref- is incorporated by reference. Copies are erence. Copies are available from the available from the Center for Food Center for Food Safety and Applied Nu- Safety and Applied Nutrition (HFS– trition (HFS–200), Food and Drug Ad- 200), Food and Drug Administration, ministration, 200 C St. SW., Wash- 200 C St. SW., Washington, DC 20204, or ington, DC 20204, or available for in- available for inspection at the Office of spection at the Office of the Federal the Federal Register, 800 North Capitol Register, 800 North Capitol Street, Street, NW., suite 700, Washington, DC NW., suite 700, Washington, DC 20408. 20408. (c)(1) The additive is used or intended (c) The additive is used or intended for use as a pure culture in the fer- for use as a pure culture in the fer- mentation process for the production mentation process for the production of citric acid using an acceptable aque- of citric acid from purified normal ous carbohydrate substrate. alkanes. (2) The organism Candida (d) The additive is so used that the quilliermondii is made nonviable and is citric acid produced conforms to the completely removed from the citric specifications of the ‘‘Food Chemicals acid during the recovery and purifi- cation process. Codex,’’ 3d Ed. (1981), pp. 86–87, which is (d) The additive is so used that the incorporated by reference. Copies may citric acid produced conforms to the be obtained from the National Acad- specifications of the ‘‘Food Chemicals emy Press, 2101 Constitution Ave. NW., Codex,’’ 3d Ed. (1981), under ‘‘Citric Washington, DC 20418, or may be exam- acid,’’ pp. 86–87, which is incorporated ined at the Office of the Federal Reg- by reference. Copies may be obtained ister, 800 North Capitol Street, NW., from the National Academy Press, 2101 suite 700, Wasington, DC 20408. The ad- Constitution Ave. NW., Washington, ditive meets the following ultraviolet DC 20418, or may be examined at the absorbance limits when subjected to Office of the Federal Register., 800 the analytical procedure described in North Capitol Street, NW., suite 700, this paragraph: Washington, DC 20408. Ultraviolet absorbance per centimeter path Maximum [42 FR 14526, Mar. 15, 1977, as amended at 47 length FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989] 280 to 289 millimicrons ...... 0.25 290 to 299 millimicrons ...... 0.20 § 173.165 Candida lipolytica. 300 to 359 millimicrons ...... 0.13 360 to 400 millimicrons ...... 0.03 The food additive Candida lipolytica may be safely used as the organism for ANALYTICAL PROCEDURE FOR CITRIC ACID fermentation production of citric acid in accordance with the following condi- GENERAL INSTRUCTIONS tions: Because of the sensitivity of the test, the (a) The food additive is the enzyme possibility of errors arising from contamina- system of the organism Candida tion is great. It is of the greatest importance lipolytica and its concimitant metabo- that all glassware be scrupulously cleaned to lites produced during the fermentation remove all organic matter such as oil, process. grease, detergent residues, etc. Examine all (b)(1) The nonpathogenic organism is glassware including stoppers and stopcocks, classified as follows: under ultraviolet light to detect any residual fluorescent contamination. As a pre- Class: Deuteromycetes. cautionary measure it is recommended prac- Order: Moniliales. tice to rinse all glassware with purified iso- Family: Cryptococcaceae. octane immediately before use. No grease is Genus: Candida. to be used on stopcocks or joints. Great care Species: lipolytica. to avoid contamination of citric acid sam- (2) The taxonomic characteristics of ples in handling is essential to assure ab- sence of any extraneous material arising the culture agree in essential with the from inadequate packaging. Because some of standard description for Candida the polynuclear hydrocarbons sought in this lipolytica variety lipolytica listed in test are very susceptible to photo-oxidation, ‘‘The Yeasts—A Toxonomic Study,’’ 2d the entire procedure is to be carried out Ed. (1970), by Jacomina Lodder, which under subdued light.
122
VerDate 06
APPARATUS Isooctane (2,2,4-trimethylpentane). Use 100 milliliters for the test. If necessary, iso- 1. Aluminum foil, oil free. octane may be purified by passage through a 2. Separatory funnels, 500-milliliter capac- column of activated silica gel, distillation or ity, equipped with tetrafluoroethylene poly- otherwise. mer stopcocks. Hexane, spectrograde (Burdick and Jackson 3. Chromatographic tubes: (a) 80-milli- Laboratories, Inc., Muskegon, Mich., or equiva- meter ID × 900-millimeter length equipped lent). Use 100 milliliters for the test. If nec- with tetrafluoroethylene polymer stopcock essary, hexane may be purified by distilla- and course fritted disk; (b) 18-millimeter ID × tion or otherwise. 300-millimeter length equipped with tetra- 1,2-Dichloroethane, spectrograde (Matheson, fluoroethylene polymer stopcock. Coleman and Bell, East Rutherford, N.J., or 4. Rotary vacuum evaporator, Buchi or equivalent). Use 100 milliliters for the test. If equivalent. necessary, 1,2-dichloroethane may be puri- 5. Spectrophotometer—Spectral range 250– fied by distillation or otherwise. 400 nanometers with spectral slit width of 2 nanometers or less; under instrument oper- ELUTING MIXTURES ating conditions for these absorbance meas- urements, the spectrophotometer shall also 1. 10 percent 1,2-dichloroethane in hexane. meet the following performance require- Prepare by mixing the purified solvents in ments: the volume ratio of 1 part of 1,2- Absorbance repeatability, ±0.01 at 0.4 ab- dichloroethane to 9 parts of hexane. sorbance. 2. 40 percent benzene in hexane. Prepare by Wavelength repeatability, ±0.2 nanometer. mixing the purified solvents in the volume Wavelength accuracy, ±1.0 nanometer. ratio of 4 parts of benzene to 6 parts of The spectrophotometer is equipped with hexane. matched 1 centimeter path length quartz n-Hexadecane, 99 percent olefin-free. Deter- microcuvettes with 0.5-milliliter volume ca- mine the absorbance compared to isooctane pacity. as reference. The absorbance per centimeter 6. Vacuum oven, minimum inside dimen- path length shall not exceed 0.00 in the range sions: 200 mm × 200 mm × 300 mm deep. of 280–400 nanometers. If necessary, n-hexa- decane may be purified by percolation REAGENTS AND MATERIALS through activated silica gel, distillation or otherwise. Organic solvents. All solvents used through- Silica gel, 28–200 mesh (Grade 12, Davison out the procedure shall meet the specifica- Chemical Co., Baltimore, MD, or equivalent). tions and tests described in this specifica- Activate as follows: Slurry 900 grams of sili- tion. The methyl alcohol, isooctane, benzene, ca gel reagent with 2 liters of purified water hexane and 1,2-dichloroethane designated in in a 3-liter beaker. Cool the mixture and the list following this paragraph shall pass pour into a 80 × 900 chromatographic column the following test: with coarse fritted disc. Drain the water, The specified quantity of solvent is added wash with an additional 6 liters of purified to a 250-milliliter round bottom flask con- water and wash with 3,600 milliliters of puri- taining 0.5 milliliter of purified n-hexa- fied methyl alcohol at a relatively slow rate. decane and evaporated on the rotary evapo- Drain all of the solvents and transfer the rator at 45 °C to constant volume. Six milli- silica gel to an aluminum foil-lined drying liters of purified isooctane are added to this dish. Place foil over the top of the dish. Acti- residue and evaporated under the same con- vate in a vacuum oven at low vacuum (ap- ditions as above for 5 minutes. Determine proximately 750 millimeters Mercury or 27 the absorbance of the residue compared to inches of Mercury below atmospheric pres- purified n-hexadecane as reference. The ab- sure) at 173° to 177 °C for at least 20 hours. sorbance of the solution of the solvent res- Cool under vacuum and store in an amber idue shall not exceed 0.03 per centimeter bottle. path length between 280 and 299 nanometers Sodium sulfate, anhydrous, A.C.S. reagent and 0.01 per centimeter path length between grade. This reagent should be washed with 300 and 400 nanometers. purified isooctane. Check the purity of this Methyl alcohol, A.C.S. reagent grade. Use 100 reagent as described in § 172.886 of this chap- milliliters for the test described in the pre- ter. ceding paragraph. If necessary, methyl alco- Water, purified. All water used must meet hol may be purified by distillation through a the specifications of the following test: Virgreaux column discarding the first and Extract 600 milliliters of water with 50 mil- last ten percent of the distillate or other- liliters of purified isooctane. Add 1 milliliter wise. of purified n-hexadecane to the isooctane ex- Benzene, spectrograde (Burdick and Jackson tract and evaporate the resulting solution to Laboratories, Inc., Muskegon, Mich., or equiva- 1 milliliter. The absorbance of this residue lent). Use 80 milliliters for the test. If nec- shall not exceed 0.02 per centimeter path essary, benzene may be purified by distilla- length between 300–400 nanometers and 0.03 tion or otherwise. per centimeter path length between 280–299
123
VerDate 06
nanometers. If necessary, water may be puri- column with 30 milliliters of 40-percent ben- fied by distillation, extraction with purified zene in hexane solution. Drain the eluate organic solvents, treatment with an absorb- until the 40-percent benzene in the hexane ent (e.g., activated carbon) followed by fil- solvent reaches the top of the sodium sulfate tration of the absorbent or otherwise. bed. Evaporate the 40-percent benzene in PROCEDURE hexane eluate on the rotary vacuum evapo- Separate portions of 200 milliliters of puri- rator at 45 °C until only the n-hexadecane fied water are taken through the procedure residue of 0.5 milliliter remains. Treat the n- for use as control blanks. Each citric acid hexadecane residue twice with the following sample is processed as follows: Weigh 200 wash step: Add 6 milliliters of purified iso- grams of anhydrous citric acid into a 500 mil- octane and remove the solvents by vacuum liliter flask and dissolve in 200 milliliters of evaporation at 45 °C to constant volume, i.e., pure water. Heat the solution to 60 °C and 0.5 milliliter. Cool the n-hexadecane residue transfer to a 500 milliliter separatory funnel. and transfer the solution to an 0.5-milliliter Rinse the flask with 50 milliliters of iso- microcuvette. Determine the absorbance of octane and add the isooctane to the sepa- this solution compared to purified n-hexa- ratory funnel. Gently shake the mixture 90 decane as reference. Correct the absorbance times (caution: vigorous shaking will cause values for any absorbance derived from the emulsions) with periodic release of the pres- control reagent blank. If the corrected ab- sure caused by shaking. sorbance does not exceed the limits pre- Allow the phases to separate for at least 5 scribed, the samples meet the ultraviolet ab- minutes. Draw off the lower aqueous layer sorbance specifications. into a second 500-milliliter separatory funnel The reagent blank is prepared by using 200 and repeat the extraction with a second ali- milliliters of purified water in place of the quot of 50 milliliters of isooctane. After sep- citric acid solution and carrying the water aration of the layers, draw off and discard sample through the procedure. The typical the water layer. Combine both isooctane ex- control reagent blank should not exceed 0.03 tracts in the funnel containing the first ex- absorbance per centimeter path length be- tract. Rinse the funnel which contained the tween 280 and 299 nanometers, 0.02 absorb- second extract with 10 milliliters of iso- ance per centimeter path length between 300 octane and add this portion to the combined and 359 nanometers, and 0.01 absorbance per isooctane extract. centimeter path length between 360 and 400 A chromatographic column containing 5.5 nanometers. grams of silica gel and 3 grams of anhydrous sodium sulfate is prepared for each citric [42 FR 14491, Mar. 15, 1977, as amended at 47 acid sample as follows: Fit 18 × 300 column FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, with a small glass wool plug. Rinse the in- 1984; 54 FR 24897, June 12, 1989] side of the column with 10 milliliters of puri- fied isooctane. Drain the isooctane from the § 173.170 Aminoglycoside 3′-phospho- column. Pour 5.5 grams of activated silica transferase II. gel into the column. Tap the column ap- The food additive aminoglycoside 3′- proximately 20 times on a semisoft, clean surface to settle the silica gel. Carefully phosphotransferase II may be safely pour 3 grams of anhydrous sodium sulfate used in the development of genetically onto the top of the silica gel in the column. modified cotton, oilseed rape, and to- Carefully drain the isooctane extract of matoes in accordance with the fol- the citric acid solution into the column in a lowing prescribed conditions: series of additions while the isooctane is (a) The food additive is the enzyme draining from the column at an elution rate aminoglycoside 3′-phosphotransferase of approximately 3 milliliters per minute. Rinse the separatory funnel with 10 milli- II (CAS Reg. No. 58943–39–8) which cata- liters of isooctane after the last portion of lyzes the phosphorylation of certain the extract has been applied to the column aminoglycoside antibiotics, including and add this rinse to the column. After all of kanamycin, neomycin, and gentamicin. the extract has been applied to the column (b) Aminoglycoside 3′-phosphotrans- and the solvent layer reaches the top of the ferase II is encoded by the kanr gene sulfate bed, rinse the column with 25 milli- originally isolated from transposon Tn5 liters of isooctane followed by 10 milliliters of a 10-percent dichloroethane in hexane so- of the bacterium Escherichia coli. lution. For each rinse solution, drain the col- (c) The level of the additive does not umn until the solvent layer reaches the top exceed the amount reasonably required of the sodium sulfate bed. Discard the rinse for selection of plant cells carrying the solvents. Place a 250-milliliter round bottom kanr gene along with the genetic mate- flask containing 0.5 milliliter of purified n- rial of interest. hexadecane under the column. Elute the polynuclear aromatic hydrocarbons from the [59 FR 26711, May 23, 1994]
124
VerDate 06
Subpart C—Solvents, Lubricants, also present the total of all residues of Release Agents and Related such solvents shall not exceed 30 parts Substances per million. § 173.210 Acetone. § 173.240 Isopropyl alcohol. A tolerance of 30 parts per million is Isopropyl alcohol may be present in established for acetone in spice the following foods under the condi- oleoresins when present therein as a tions specified: residue from the extraction of spice. (a) In spice oleoresins as a residue from the extraction of spice, at a level § 173.220 1,3-Butylene glycol. not to exceed 50 parts per million. 1,3-Butylene glycol (1,3-butanediol) (b) In lemon oil as a residue in pro- may be safely used in food in accord- duction of the oil, at a level not to ex- ance with the following prescribed con- ceed 6 parts per million. ditions: (c) In hops extract as a residue from (a) The substance meets the fol- the extraction of hops at a level not to lowing specifications: exceed 2.0 percent by weight: Provided, (1) 1,3-Butylene glycol content: Not That, less than 99 percent. (1) The hops extract is added to the (2) Specific gravity at 20/20 °C: 1.004 wort before or during cooking in the to 1.006. manufacture of beer. (3) Distillation range: 200°–215 °C. (2) The label of the hops extract (b) It is used in the minimum amount specifies the presence of the isopropyl required to perform its intended effect. alcohol and provides for the use of the (c) It is used as a solvent for natural hops extract only as prescribed by and synthetic flavoring substances ex- paragraph (c)(1) of this section. cept where standards of identity issued under section 401 of the act preclude § 173.250 Methyl alcohol residues. such use. Methyl alcohol may be present in the following foods under the conditions § 173.228 Ethyl acetate. specified: Ethyl acetate (CAS Reg. No. 141–78–6) (a) In spice oleoresins as a residue may be safely used in food in accord- from the extraction of spice, at a level ance with the following conditions: not to exceed 50 parts per million. (a) The additive meets the specifica- (b) In hops extract as a residue from 1 tions of the Food Chemicals Codex, the extraction of hops, at a level not to (Ethyl Acetate; p. 372, 3d Ed., 1981), exceed 2.2 percent by weight; Provided, which are incorporated by reference. That: (b) The additive is used in accordance (1) The hops extract is added to the with current good manufacturing prac- wort before or during cooking in the tice as a solvent in the decaffeination of coffee and tea. manufacture of beer. (2) The label of the hops extract [47 FR 146, Jan. 5, 1982, as amended at 49 FR specifies the presence of methyl alco- 28548, July 13, 1984] hol and provides for the use of the hops extract only as prescribed by para- § 173.230 Ethylene dichloride. graph (b)(1) of this section. A tolerance of 30 parts per million is established for ethylene dichloride in § 173.255 Methylene chloride. spice oleoresins when present therein Methylene chloride may be present in as a residue from the extraction of food under the following conditions: spice; Provided, however, That if resi- (a) In spice oleoresins as a residue dues of other chlorinated solvents are from the extraction of spice, at a level not to exceed 30 parts per million; Pro- 1 Copies may be obtained from: National vided, That, if residues of other Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418 or examined at the Of- chlorinated solvents are also present, fice of the Federal Register, 800 North Cap- the total of all residues of such sol- itol Street, NW., suite 700, Washington, DC vents shall not exceed 30 parts per mil- 20408. lion.
125
VerDate 06
(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 percent) in decaffeinated roasted coffee ter, and tridodecyl amine. and in decaffeinated soluble coffee ex- (b) The component substances are tract (instant coffee). used solely as a solvent mixture and in a manner that does not result in for- § 173.270 Hexane. mation of products not present in con- ventionally produced citric acid. Hexane may be present in the fol- lowing foods under the conditions spec- (c) The citric acid so produced meets ified: the specifications of the ‘‘Food Chemi- (a) In spice oleoresins as a residue cals Codex,’’ 3d Ed. (1981), pp. 86–87, from the extraction of spice, at a level which is incorporated by reference not to exceed 25 parts per million. (copies may be obtained from the Na- (b) In hops extract as a residue from tional Academy Press, 2101 Constitu- the extraction of hops, at a level not to tion Ave. NW., Washington, DC 20418, exceed 2.2 percent by weight; Provided, or may be examined at the Office of the That: Federal Register, 800 North Capitol (1) The hops extract is added to the Street, NW., suite 700, Washington, DC wort before or during cooking in the 20408), and the polynuclear aromatic manufacture of beer. hydrocarbon specifications of § 173.165. (2) The label of the hops extract (d) Residues of n-octyl alcohol and specifies the presence of the hexane synthetic isoparaffinic petroleum hy- and provides for the use of the hops ex- drocarbons are removed in accordance tract only as prescribed by paragraph with good manufacturing practice. Cur- (b)(1) of this section. rent good manufacturing practice re- sults in residues not exceeding 16 parts § 173.275 Hydrogenated sperm oil. per million (ppm) n-octyl alcohol and The food additive hydrogenated 0.47 ppm synthetic isoparaffinic petro- sperm oil may be safely used in accord- leum hydrocarbons in citric acid. ance with the following prescribed con- (e) Tridodecyl amine may be present ditions: as a residue in citric acid at a level not (a) The sperm oil is derived from ren- to exceed 100 parts per billion. dering the fatty tissue of the sperm [42 FR 14491, Mar. 15, 1977, as amended at 49 whale or is prepared by synthesis of FR 10106, Mar. 19, 1984] fatty acids and fatty alcohols derived from the sperm whale. The sperm oil § 173.290 Trichloroethylene. obtained by rendering is refined. The Tolerances are established for resi- oil is hydrogenated. dues of trichloroethylene resulting (b) It is used alone or as a component from its use as a solvent in the manu- of a release agent or lubricant in bak- facture of foods as follows: ery pans. Decaffeinated ground 25 parts per million. (c) The amount used does not exceed coffee. that reasonably required to accomplish Decaffeinated soluble 10 parts per million. the intended lubricating effect. (instant) coffee extract.
126
VerDate 06
Spice oleoresins ...... 30 parts per million (pro- (b)(1) The additive may be used as an vided that if residues antimicrobial agent in water used in of other chlorinated solvents are also poultry processing in an amount not to present, the total of all exceed 3 parts per million (ppm) resid- residues of such sol- ual chlorine dioxide as determined by vents in spice oleoresins shall not ex- Method 4500–ClO2 E, referenced in para- ceed 30 parts per mil- graph (a) of this section, or an equiva- lion). lent method. (2) The additive may be used as an Subpart D—Specific Usage antimicrobial agent in water used to Additives wash fruits and vegetables that are not raw agricultural commodities in an § 173.300 Chlorine dioxide. amount not to exceed 3 ppm residual Chlorine dioxide (CAS Reg. No. 10049– chlorine dioxide as determined by 04–4) may be safely used in food in ac- Method 4500–ClO2 E, referenced in para- cordance with the following prescribed graph (a) of this section, or an equiva- conditions: lent method. Treatment of the fruits (a) The additive is generated by and vegetables with chlorine dioxide treating an aqueous solution of sodium shall be followed by a potable water chlorite with either chlorine gas or a rinse or by blanching, cooking, or can- mixture of sodium hypochlorite and ning. hydrochloric acid. The generator efflu- [60 FR 11900, Mar. 3, 1995. Redesignated at 61 ent contains at least 90 percent (by FR 14245, Apr. 1, 1996, as amended at 61 FR weight) of chlorine dioxide with re- 14480, Apr. 2, 1996; 63 FR 38747, July 20, 1998] spect to all chlorine species as deter- mined by Method 4500–ClO2 E in the § 173.310 Boiler water additives. ‘‘Standard Methods for the Examina- tion of Water and Wastewater,’’ 18th Boiler water additives may be safely ed., 1992, or an equivalent method. used in the preparation of steam that will contact food, under the following Method 4500–ClO2 E is incorporated by reference in accordance with 5 U.S.C. conditions: 552(a) and 1 CFR part 51. Copies are (a) The amount of additive is not in available from the Center for Food excess of that required for its func- Safety and Applied Nutrition (HFS– tional purpose, and the amount of 200), Food And Drug Administration, steam in contact with food does not ex- 200 C St., SW., Washington, DC 20204– ceed that required to produce the in- 0001 and The American Public Health tended effect in or on the food. Association, 1015 Fifteenth St., NW., (b) The compounds are prepared from Washington, DC 20005, or may be exam- substances identified in paragraphs (c) ined at the Office of the Federal Reg- and (d) of this section, and are subject ister, 800 North Capitol St., NW., suite to the limitations, if any, prescribed: 700, Washington, DC. (c) List of substances:
Substances Limitations
Acrylamide-sodium acrylate resin ...... Contains not more than 0.05 percent by weight of acrylamide monomer. Acrylic acid/2-acrylamido-2-methyl propane sulfonic acid copoly- Total not to exceed 20 parts per million (active) in boiler mer having a minimum weight average molecular weight of feedwater. 9,900 and a minimum number average molecular weight of 5,700 as determined by a method entitled ``Determination of Weight Average and Number Average Molecular Weight of 60/40 AA/AMPS'' (October 23, 1987), which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies may be obtained from the Center for Food Safety and Applied Nu- trition (HFS±200), Food and Drug Administration, 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. 2809±21±4) and its sodium and potassium salts. Lignosulfonic acid.
127
VerDate 06
Substances Limitations
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. 71050±62±9), produced from a 4:1 to a 16:1 mixture by Copolymer contains not more than 0.5 percent by weight of weight of acrylic acid and sodium hypophosphite. acrylic acid monomer (dry weight basis). Polyethylene glycol ...... As defined in § 172.820 of this chapter. Polymaleic acid [CAS Reg. No. 26099±09±2], and/or its sodium Total not to exceed 1 part per million in boiler feed water (cal- salt. [CAS Reg. No. 30915±61±8 or CAS Reg. No. 70247± culated as the acid). 90±4]. Polyoxypropylene glycol ...... Minimum mol. wt. 1,000. Potassium carbonate. Potassium tripolyphosphate. Sodium acetate. Sodium alginate. Sodium aluminate. Sodium carbonate. Sodium carboxymethylcellulose ...... Contains not less than 95 percent sodium carboxymethylcellulose on a dry-weight basis, with 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. 744±745, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address ``http://www.nap.edu''), or may be examined at the Center for Food Safety and Applied 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. Sodium sulfite (neutral or alkaline). Sodium tripolyphosphate. 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.
128
VerDate 06
(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] tions as are provided:
Substances Limitations
A mixture of alkylene oxide adducts of alkyl alcohols and phosphate May be used at a level not to exceed 0.2 percent in esters of alkylene oxide adducts of alkyl alcohols consisting of: α-alkyl lye-peeling solution to assist in the lye peeling of (C12-C18)-omega-hydroxy-poly (oxyethylene) (7.5±8.5 moles)/poly fruit and vegetables. (oxypropylene) block copolymer having an average molecular weight of 810; α-alkyl (C12-C18)-omega-hydroxy-poly (oxyethylene) (3.3±3.7 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) (11.9±12.9 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. 1-Hydroxyethylidene-1,1-diphosphonic acid ...... May be used only with peroxyacetic acid. Not to ex- ceed 4.8 ppm in wash water. Limited to use on fruits and vegetables that are not raw agricultural commodities. Hydrogen peroxide ...... Used in combination with acetic acid to form peroxy- acetic acid. Not to exceed 59 ppm in wash water. Limited to use on fruits and vegetables that are not raw agricultural commodities. Peroxyacetic acid ...... Prepared by reacting acetic acid with hydrogen per- oxide. Not to exceed 80 ppm in wash water. Lim- ited to use on fruits and vegetables that are not raw agricultural commodities. Polyacrylamide ...... Not to exceed 10 parts per million in wash water. Contains not more than 0.2 percent acrylamide monomer. May be used in the washing of fruits and vegetables. Potassium bromide ...... May be used in the washing or to assist in the lye peeling of fruits and vegetables. Sodium n-alkylbenzene-sulfonate (alkyl group predominantly C12 and C13 Not to exceed 0.2 percent in wash water. May be and not less than 95 percent C10 to C16). used in washing or to assist in the lye peeling of fruits and vegetables. Sodium dodecylbenzene-sulfonate (alkyl group predominantly C12 and Do. not less than 95% C10 to C16). Sodium 2 ethyl-hexyl sulfate ...... Do. Sodium hypochlorite ...... May be used in the washing or to assist in the lye peeling of fruits and vegetables. Sodium mono- and dimethyl naphthalene sulfonates (mol. wt. 245±260) Not to exceed 0.2 percent in wash water. May be used in the washing or to assist in the lye peeling of fruits and vegetables.
(3) Sodium mono- and dimethyl naph- exceed 0.2 percent in the condensate or thalene sulfonates (mol. wt. 245–260) scald water. may be used in the steam/scald vacuum (4) Substances identified in this para- peeling of tomatoes at a level not to graph (a)(4) for use in flume water for washing sugar beets prior to the slicing
129
VerDate 06
operation and subject to the limita- (b) They are applied to the sugar mill tions as are provided for the level of grinding, crusher, and/or diffuser sys- the substances in the flume water: tems in one of the combinations listed in paragraph (b) (1), (2), (3), or (5) of Substance Limitations this section or as a single agent listed α-Alkyl-omega-hydroxypoly-(oxy- Not to exceed 3 ppm. in paragraph (b) (4) or (6) of this sec- ethylene) produced by con- tion. Quantities of the individual addi- densation of 1 mole of C11- tives in parts per million are expressed C486315 straight chain ran- domly substituted secondary al- in terms of the weight of the raw cane cohols with an average of 9 or raw beets. moles of ethylene oxide. (1) Combination for cane-sugar mills: Linear undecylbenzenesulfonic Do. acid. Parts Dialkanolamide produced by con- Not to exceed 2 ppm. per mil- densing 1 mole of methyl lau- lion rate with 1.05 moles of diethanolamine.. Disodium cyanodithioimidocarbonate ...... 2.5 Triethanolamine ...... Do. Ethylenediamine ...... 1.0 Ethylene glycol monobutyl ether .. Not to exceed 1 ppm. Potassium N-methyldithiocarbamate ...... 3.5 Oleic acid conforming with Do. § 172.860 of this chapter. (2) Combination for cane-sugar mills: Tetrapotassium pyrophosphate .... Not to exceed 0.3 ppm. Monoethanolamine ...... Do. Parts Ethylene dichloride ...... Not to exceed 0.2 ppm. per mil- Tetrasodium ethylenediamine- Not to exceed 0.1 ppm. lion tetraacetate. Disodium ethylenebisdithiocarbamate ...... 3.0 Sodium dimethyldithiocarbamate ...... 3.0 (b) The chemicals are used in amounts not in excess of the minimum (3) Combinations for cane-sugar mills required to accomplish their intended and beet-sugar mills: effect. Parts (c) The use of the chemicals listed per mil- under paragraphs (a)(1), (a)(2), and lion (a)(4) is followed by rinsing with pota- (i) Disodium ethylenebisdithiocarbamate ...... 3.0 ble water to remove, to the extent pos- Ethylenediamine ...... 2.0 sible, residues of the chemicals. Sodium dimethyldithiocarbamate ...... 3.0 (d) To assure safe use of the additive: (ii) Disodium cyanodithioimidocarbonate ...... 2.9 (1) The label and labeling of the addi- Potassium N-methyldithiocarbamate ...... 4.1 tive container shall bear, in addition to (4) Single additive for cane-sugar the other information required by the mills and beet-sugar mills. act, the name of the additive or a statement of its composition. Parts per million (2) The label or labeling of the addi- 2,2-Dibromo-3-nitrilopropionamide (CAS Not more than tive container shall bear adequate use Reg. No. 10222±01±2). Limitations: By- 10.0 and not directions to assure use in compliance product molasses, bagasse, and pulp less than 2.0. with all provisions of this section. containing residues of 2,2-dibromo-3- nitrilopropionamide are not authorized [42 FR 14526, Mar. 15, 1977, as amended at 42 for use in animal feed.. FR 29856, June 10, 1977; 42 FR 32229, June 24, 1977; 43 FR 54926, Nov. 24, 1978; 61 FR 46376, (5) Combination for cane-sugar mills: 46377, Sept. 3, 1996; 63 FR 7069, Feb. 12, 1998] Parts per mil- § 173.320 Chemicals for controlling lion microorganisms in cane-sugar and n-Dodecyl dimethyl benzyl ammonium chlo- beet-sugar mills. ride ...... 0.05±0.005 n-Dodecyl dimethyl ethylbenzyl ammonium Agents for controlling microorga- chloride ...... 0.68±0.068 nisms in cane-sugar and beet-sugar n-Hexadecyl dimethyl benzyl ammonium mills may be safely used in accordance chloride ...... 0.30±0.030 n-Octadecyl dimethyl benzyl ammonium with the following conditions: chloride ...... 0.05±0.005 (a) They are used in the control of n-Tetradecyl dimethyl benzyl ammonium microorganisms in cane-sugar and/or chloride ...... 0.60±0.060 beet-sugar mills as specified in para- n-Tetradecyl dimethyl ethylbenzyl ammo- nium chloride ...... 0.32±0.032 graph (b) of this section.
130
VerDate 06
Limitations. Byproduct molasses, ba- (a) The additive is produced by mix- gasse, and pulp containing residues of ing an aqueous solution of sodium chlo- these quaternary ammonium salts are rite (CAS Reg. No. 7758–19–2) with any not authorized for use in animal feed. generally recognized as safe (GRAS) (6) Single additive for beet-sugar acid. mills: (b) The additive is used as an anti- microbial agent in poultry processing Parts per million water as a component of a carcass Glutaraldehyde (CAS Reg. No. Not more than 250. spray or dip solution prior to immer- 111±30±8). sion of the carcass in a prechiller or chiller tank, or in a prechiller or chill- (c) To assure safe use of the addi- tives, their label and labeling shall er solution in accordance with current conform to that registered with the industry practice for use of poultry Environmental Protection Agency. process water. (1) When used in a carcass spray or [42 FR 14526, Mar. 15, 1977, as amended at 47 dip solution, the additive is used at lev- FR 35756, Aug. 17, 1982; 50 FR 3891, Jan. 29, els that result in sodium chlorite con- 1985; 57 FR 8065, Mar. 6, 1992] centrations between 500 and 1,200 parts § 173.322 Chemicals used in delinting per million (ppm), in combination with cottonseed. any GRAS acid at levels sufficient to Chemicals may be safely used to as- achieve a solution pH of 2.5 to 2.9. sist in the delinting of cottonseed in (2) When used in a prechiller or chill- accordance with the following condi- er tank, the additive is used at levels tions: that result in sodium chlorite con- (a) The chemicals consist of one or centrations between 50 and 150 ppm, in more of the following: combination with any GRAS acid at (1) Substances generally recognized levels sufficient to achieve a solution as safe for direct addition to food. pH of 2.8 to 3.2. (2) Substances identified in this para- (c) The additive is used as an anti- graph and subject to such limitations microbial agent in the processing of as are provided: red meat as a component of a carcass spray in accordance with current in- Substances Limitations dustry practice. In the carcass spray, alpha-Alkyl-omega- May be used at an applica- the additive is used at levels that re- hydroxypoly-(oxyethylene) tion rate not to exceed 0.3 sult in sodium chlorite concentrations produced by condensation percent by weight of cot- of a linear primary alcohol tonseeds to enhance between 500 and 1,200 parts per million containing an average delinting of cottonseeds in- (ppm) in combination with any GRAS chain length of 10 carbons tended for the production acid at levels sufficient to achieve a so- with poly(oxyethylene) hav- of cottonseed oil. Byprod- ing an average of 5 ethyl- ucts including lint, hulls, lution pH of 2.5 to 2.9. ene oxide units. and meal may be used in (d) The concentration of sodium chlo- animal feed. rite is determined by a method entitled An alkanomide produced by May be used at an applica- condensation of coconut oil tion rate not to exceed 0.2 ‘‘Determination of Sodium Chlorite: 50 fatty acids and dietha- percent by weight of cot- ppm to 1500 ppm Concentration,’’ Sep- nolamine, CAS Reg. No. tonseeds to enhance tember 13, 1995, developed by Alcide 068603±42±9. delinting of cottonseeds in- tended for the production Corp., Redmond, WA, which is incor- of cottonseed oil. Byprod- porated by reference in accordance ucts including lint, hulls, with 5 U.S.C. 552(a) and 1 CFR part 51. and meal may be used in animal feed. Copies are available from the Division of Petition Control (HFS–215), Center for Food Safety and Applied Nutrition, [47 FR 8346, Feb. 26, 1982] Food and Drug Administration, 200 C § 173.325 Acidified sodium chlorite so- St. SW., Washington, DC 20204–0001, or lutions. may be examined at the Center for Acidified sodium chlorite solutions Food Safety and Applied Nutrition’s may be safely used in accordance with Library, 200 C St. SW., rm. 3321, Wash- the following prescribed conditions: ington, DC 20204–0001, or the Office of
131
VerDate 06
the Federal Register, 800 North Capitol (a) They consist of one or more of the St. NW., suite 700, Washington, DC. following: [61 FR 17829, Apr. 23, 1996, as amended at 63 (1) Substances generally recognized FR 11119, Mar. 6, 1998] by qualified experts as safe in food or covered by prior sanctions for the use § 173.340 Defoaming agents. prescribed by this section. Defoaming agents may be safely used (2) Substances listed in this para- in processing foods, in accordance with graph (a)(2) of this section, subject to the following conditions: any limitations imposed:
Substances Limitations
Dimethylpolysiloxane (substantially free from hydrolyzable chlo- 10 parts per million in food, or at such level in a concentrated ride and alkoxy groups; no more than 18 percent loss in food that when prepared as directed on the labels, the food weight after heating 4 hours at 200 °C; viscosity 300 to 1,050 in its ready-for-consumption state will have not more than centistokes at 25 °C; refractive index 1.400±1.404 at 25 °C). 10 parts per million except as follows: Zero in milk; 110 parts per million in dry gelatin dessert mixes labeled for use whereby no more than 16 parts per million is present in the ready-to-serve dessert; 250 parts per million in salt labeled for cooking purposes, whereby no more than 10 parts per million is present in the cooked food. Formaldehyde ...... As a preservative in defoaming agents containing dimethylpolysiloxane, in an amount not exceeding 1.0 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. 9003±11±6) as defined in § 172.808(a)(3) of this chapter. Polyacrylic acid, sodium salt ...... As a stabilizer and thickener in defoaming agents containing dimethylpolysiloxane in an amount reasonably required to accomplish the intended effect. Polyethylene glycol ...... As defined in § 172.820 of this chapter. Polyoxyethylene 40 monostearate ...... As defined in U.S.P. XVI. Polysorbate 60 ...... As defined in § 172.836 of this chapter. Polysorbate 65 ...... As defined in § 172.838 of this chapter. Propylene glycol alginate ...... As defined in § 172.858 of this chapter. Silicon dioxide ...... As defined in § 172.480 of this chapter. Sorbitan monostearate ...... As defined in § 172.842 of this chapter. White mineral oil: Conforming with § 172.878 of this chapter ...... As a component of defoaming agents for use in wash water for sliced potatoes at a level not to exceed 0.008 percent of the wash water.
(3) Substances listed in this 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. 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.
132
VerDate 06
Substances Limitations
Oxystearin ...... As defined in § 172.818 of this chapter. Polyoxyethylene (600) dioleate. Polyoxyethylene (600) monoricinoleate. Polypropylene glycol ...... Molecular weight range, 1,200±3,000. Polysorbate 80 ...... As defined in § 172.840 of this chapter. Potassium stearate ...... As defined in § 172.863 of this chapter. Propylene glycol mono- and diesters of fats and fatty acids ...... As defined in § 172.856 of this chapter. Soybean oil fatty acids, hydroxylated. Tallow, hydrogenated, oxidized or sulfated. Tallow alcohol, hydrogenated.
(4) The substances listed in this para- (b) They are added in an amount not graph (a)(4), provided they are compo- in excess of that reasonably required to nents of defoaming agents limited to inhibit foaming. use in processing beet sugar only, and [42 FR 14526, Mar. 15, 1977, as amended at 43 subject to the limitations imposed: FR 2872, Jan. 20, 1978; 46 FR 30493, June 9, 1981; 46 FR 57476, Nov. 24, 1981; 60 FR 54036, Substances Limitations Oct. 19, 1995; 61 FR 632, Jan. 9, 1996; 63 FR 29134, May 28, 1998] n-Butoxypoly(oxyethylene)- Viscosity range, 4,850±5,350 poly(oxypropylene)glycol. Saybolt Universal Seconds (SUS) at 37.8 °C (100 °F). § 173.342 Chlorofluorocarbon 113 and The viscosity range is de- perfluorohexane. termined by the method A mixture of 99 percent ``Viscosity Determination of n-butoxypoly(oxyethylene)- chlorofluorocarbon 113 (1,1,2-trichloro- poly(oxypropylene) glycol'' 1,2,2-trifluoroethane) (CAS Reg. No. 76– dated April 26, 1995, de- 13–1, also known as fluorocarbon 113, veloped by Union Carbide CFC 113 and FC 113) and 1 percent Corp., P.O. Box 670, Bound Brook, NJ 08805, perfluorohexane (CAS Reg. No. 355–42– which is incorporated by 0) may be safely used in accordance reference in accordance with the following prescribed condi- with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the tions: material incorporated by (a) The additive chlorofluorocarbon reference are available 113 has a purity of not less than 99.99 from the Division of Petition percent. Control, Center for Food Safety and Applied Nutri- (b) The additive mixture is intended tion (HFS±215), Food and for use to quickly cool or crust-freeze Drug Administration, 200 C chickens sealed in intact bags com- St. SW., Washington, DC posed of substances regulated in parts 20204, and may be exam- ined at the Center for Food 174, 175, 177, 178, and § 179.45 of this Safety and Applied Nutri- chapter and conforming to any limita- tion's Library, 200 C St. tions or specifications in such regula- SW., rm. 3321, Wash- ington, DC, or at the Office tions. of the Federal Register, [55 FR 8913, Mar. 9, 1990] 800 North Capitol St. NW., suite 700, Washington, DC. Monoester of alpha-hydro- § 173.345 Chloropentafluoroethane. omega-hydroxy- The food additive poly(oxyethylene) chloropentafluoroethane may be safely poly(oxypropylene) poly(oxyethylene) (15 mole used in food in accordance with the fol- minimum) blocked copoly- lowing prescribed conditions: mer derived from low eru- (a) The food additive has a purity of cic acid rapeseed oil. not less than 99.97 percent, and con- tains not more than 200 parts per mil- lion saturated fluoro compounds and 10 parts per million unsaturated fluoro compounds as impurities. (b) The additive is used or intended for use alone or with one or more of the following substances: Carbon dioxide,
133
VerDate 06
nitrous oxide, propane, and (c) It is used or intended for use to octafluorocyclobutane complying with displace or remove oxygen in the proc- § 173.360, as an aerating agent for essing, storage, or packaging of bev- foamed or sprayed food products, with erage products and other food, except any propellant effect being incidental fresh meats. and no more than is minimally nec- (d) To assure safe use of the additive essary to achieve the aerating func- in addition to the other information re- tion, except that use is not permitted quired by the act, the label or labeling for those standardized foods that do of the combustion device shall bear not provide for such use. adequate directions for use to provide a (c) To assure safe use of the additive combustion product gas that complies (1) The label of the food additive con- with the limitations prescribed in para- tainer shall bear, in addition to the graph (b) of this section, including in- other information required by the act, structions to assure proper filtration. the following: (e) The food additive is tested for (i) The name of the additive, compliance with paragraph (b)(2) by chloropentafluoroethane. the following empirical method: (ii) The percentage of the additive Spectrophotometric measurements. All meas- present in the case of a mixture. urements are made in an ultraviolet spectro- (iii) The designation ‘‘food grade’’. photometer in optical cells of 5 centimeters (2) The label or labeling of the food in length, and in the range of 255 milli- 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 The food additive combustion prod- in 5-centimeter cells. (This absorbance will uct gas may be safely used in the proc- be approximately 0.30.) essing and packaging of the foods des- Solvent. The solvent used is pure grade iso- ignated in paragraph (c) of this section octane having an ultraviolet absorbance not 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- (a) The food additive is manufactured ering of the absorbance value has been ob- by the controlled combustion in air of served. The absorbance of isooctane to be butane, propane, or natural gas. The used in this procedure shall not be more than combustion equipment shall be pro- 0.02 lower in the range 255 millimicrons to vided with an absorption-type filter ca- 310 millimicrons, inclusive, than that of the untreated solvent as measured in a 5-centi- pable of removing possible toxic impu- meter cell. If necessary to obtain the pre- rities, through which all gas used in scribed purities, the isooctane may be passed the treatment of food shall pass; and through activated silica gel. with suitable controls to insure that Apparatus. To assure reproducible results, any combustion products failing to the additive is passed into the isooctane so- meet the specifications provided in this lution through a gas-absorption train con- section will be prevented from reaching sisting of the following components and nec- essary connections: the food being treated. 1. A gas flow meter with a range up to 30 (b) The food additive meets the fol- liters per hour provided with a constant dif- lowing specifications: ferential relay or other device to maintain a (1) Carbon monoxide content not to constant flow rate independent of the input exceed 4.5 percent by volume. pressure. (2) The ultraviolet absorbance in iso- 2. An absorption apparatus consisting of an octane solution in the range 255 milli- inlet gas dispersion tube inserted to the bot- tom of a covered cylindrical vessel with a microns to 310 millimicrons not to ex- suitable outlet on the vessel for effluent gas. ceed one-third of the standard ref- The dimensions and arrangement of tube and erence absorbance when tested as de- vessel are such that the inlet tube introduces scribed in paragraph (e) of this section. the gas at a point not above 51⁄4 inches below
134
VerDate 06
the surface of the solvent through a sintered § 173.355 Dichlorodifluoromethane. glass outlet. The dimensions of the vessel are such, and both inlet and vessel are so de- The food additive dichlorodi- signed, that the gas can be bubbled through fluoromethane may be safely used in 60 milliliters of isooctane solvent at a rate food in accordance with the following up to 30 liters per hour without mechanical prescribed conditions: loss of solvent. The level corresponding to 60 (a) The additive has a purity of not milliliters should be marked on the vessel. less than 99.97 percent. 3. A cooling bath containing crushed ice (b) It is used or intended for use, in and water to permit immersion of the ab- sorption vessel at least to the solvent level accordance with good manufacturing mark. practice, as a direct-contact freezing Caution. The various parts of the absorp- agent for foods. tion train must be connected by gas-tight (c) To assure safe use of the additive: tubing and joints composed of materials (1) The label of its container shall which will neither remove components from bear, in addition to the other informa- nor add components to the gas stream. The tion required by the act, the following: gas source is connected in series to the flow- (i) The name of the additive, dichlo- rate device, the flow meter, and the absorp- rodifluoromethane, with or without the tion apparatus in that order. Ventilation should be provided for the effluent gases parenthetical name ‘‘Food Freezant which may contain carbon monoxide. 12’’. Sampling procedure. Immerse the gas-ab- (ii) The designation ‘‘food grade’’. sorption apparatus containing 60 milliliters (2) The label or labeling of the food of isooctane in the coolant bath so that the additive container shall bear adequate solvent is completely immersed. Cool for at directions for use. least 15 minutes and then pass 120 liters of the test gas through the absorption train at § 173.357 Materials used as fixing a rate of 30 liters per hour or less. Maintain agents in the immobilization of en- the coolant bath at 0 °C throughout. Remove zyme preparations. the absorption vessel from the bath, dis- connect, and warm to room temperature. Fixing agents may be safely used in Add isooctane to bring the contents of the the immobilization of enzyme prepara- absorption vessel to 60 milliliters, and mix. tions in accordance with the following Determine the absorbance of the solution in conditions: the 5-centimeter cell in the range 255 milli- (a) The materials consist of one or microns to 310 millimicrons, inclusive, com- more of the following: pared to isooctane. The absorbance of the so- (1) Substances generally recognized lution of combustion product gas shall not exceed that of the isooctane solvent at any as safe in food. wavelength in the specified range by more (2) Substances identified in this sub- than one-third of the standard reference ab- paragraph and subject to such limita- sorbance. 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. 10450±60± 9)..
135
VerDate 06
Substances Limitations
Polyethylenimine reaction product with May be used as a fixing material in the immobilization of glucoamylase enzyme 1,2-dichloroethane (CAS Reg.No. preparations from Aspergillus niger for use in the manufacture of beer. 68130±97±2) is the reaction product of May be used as a fixing material in the immobilization of: homopolymerization of ethylenimine in 1. Glucose isomerase enzyme preparations for use in the manufacture of high fruc- aqueous hydrochloric acid at 100 °C tose corn syrup, in accordance with § 184.1372 of this chapter. and of cross-linking with 1,2- 2. Glucoamylase enzyme preparations from Aspergillus niger for use in the manu- dichloroethane. The finished polymer facture of beer. Residual ethylenimine in the finished polyethylenimine polymer has an average molecular weight of will be less than 1 part per million as determined by gas chromatography-mass 50,000 to 70,000 as determined by gel spectrometry. The residual ethylenimine is determined by an analytical method permeation chromatography. The analyt- entitled ``Methodology for Ethylenimine Detection in Polyethylenimine,'' which is ical method is entitled ``Methodology for incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Molecular Weight Detection of Residual 1,2-dichloroethane in the finished polyethylenimine polymer will be less Polyethylenimine,'' which is incorporated than 1 part per million as determined by gas chromatography. The residual 1,2- by reference in accordance with 5 dichloroethane is determined by an analytical method entitled, ``Methodology for U.S.C. 552(a) and 1 CFR part 51. Cop- Ethylenedichloride Detection in Polyethylenimine,'' which is incorporated by ref- ies may be obtained from the Division of erence in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be Petition Control, Center for Food Safety obtained from the Division of Petition Control, Center for Food Safety and Applied and Applied Nutrition (HFS±200), 200 C Nutrition (HFS±215), 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’’. (2) The label or labeling of the food [48 FR 5716, Feb. 8, 1983, as amended at 52 FR 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] § 173.385 Sodium methyl sulfate. § 173.360 Octafluorocyclobutane. Sodium methyl sulfate may be The food additive octafluorocyclo-bu- present in pectin in accordance with tane may be safely used as a propellant the following conditions. and aerating agent in foamed or (a) It is present as the result of sprayed food products in accordance methylation of pectin by sulfuric acid with the following conditions: and methyl alcohol and subsequent (a) The food additive meets the fol- treatment with sodium bicarbonate. lowing specifications: (b) It does not exceed 0.1 percent by weight of the pectin. 99.99 percent octafluorocyclobutane. Less than 0.1 part per million fluoroolefins, § 173.395 Trifluoromethane sulfonic calculated as perfluoroisobutylene. acid. (b) The additive is used or intended Trifluoromethane sulfonic acid has for use alone or with one or more of the the empirical formula CF 3 SO 3 H (CAS following substances: Carbon dioxide, Reg. No. 1493–13–6). The catalyst nitrous oxide, and propane, as a propel- (Trifluoromethane sulfonic acid) may lant and aerating agent for foamed or safely be used in the production of sprayed food products, except for those cocoa butter substitute from palm oil standardized foods that do not provide (1-palmitoyl-2-oleoyl-3-stearin) (see for such use. § 184.1259 of this chapter) in accordance (c) To assure safe use of the additive: with the following conditions: (1) The label of the food additive con- (a) The catalyst meets the following tainer shall bear, in addition to the specifications: other information required by the act, Appearance, Clear liquid. the following: Color, Colorless to amber. (i) The name of the additive, Neutralization equivalent, 147–151. octafluorocyclobutane. Water, 1 percent maximum.
136
VerDate 06
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- imum. drogenated tallow ammonium chloride 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 removed by washing batches of the by weight of free amine and amine hy- product three times with an aqueous drochloride. The food additive de- solution of 0.5 percent sodium bicar- scribed in paragraph (a)(2) of this sec- bonate. tion contains not more than 3 percent (d) No residual catalyst may remain by weight, each, of free amine and in the product at a detection limit of amine hydrochloride as determined by 0.2 part per million fluoride as deter- A.O.C.S. method Te 3a–64, ‘‘Acid Value mined by the method described in ‘‘Of- and Free Amine Value of Fatty Quater- ficial Methods of Analysis of the Asso- nary Ammonium Chlorides,’’ 2d print- ciation of Official Analytical Chem- ing including additions and revisions ists,’’ sections 25.049–25.055, 13th Ed. 1990, which is incorporated by reference (1980), which is incorporated by ref- in accordance with 5 U.S.C. 552(a) and 1 erence. Copies may be obtained from CFR part 51. Copies are available from the Association of Official Analytical the Center for Food Safety and Applied Chemists International, 481 North Nutrition (HFS–200), Food and Drug Frederick Ave., suite 500, Gaithersburg, Administration, 200 C St. SW., Wash- MD 20877–2504, or may be examined at ington, DC 20204, and from the Amer- the Office of the Federal Register, 800 ican Oil Chemists’ Society, P.O. Box North Capitol Street, NW., suite 700, 5037, Station A, Champaign, IL 61820, or Washington, DC 20408. available for inspection at the Office of [43 FR 54237, Nov. 11, 1978, as amended at 49 the Federal Register, 800 North Capitol FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, Street, NW., suite 700, Washington, DC. 1989] (c) The food additive is used as a de- colorizing agent in the clarification of § 173.400 Dimethyldialkylammonium refinery sugar liquors under the fol- chloride. lowing limitations: Dimethyldialkylammonium chloride (1) The food additive described in may be safely used in food in accord- paragraph (a)(1) of this section is added ance with the following prescribed con- only at the defecation/clarification ditions: stage of sugar liquor refining in an (a) The food additive is produced by amount not to exceed 700 parts per mil- one of the following methods: lion by weight of sugar solids. (1) Ammonolysis of natural tallow fatty acids to form amines that are (2) The food additive described in subsequently reacted with methyl chlo- paragraph (a)(2) of this section is used ride to form the quaternary ammonium under the following conditions: compounds consisting primarily of (i) The additive is adsorbed onto a dimethyldioctadecylammonium chlo- support column composed of suitable ride and dimethyldihexadecyl- polymers that are regulated for con- ammonium chloride. The additive may tact with aqueous food. Excess non- contain residues of isopropyl alcohol adsorbed additive shall be rinsed away not in excess of 18 percent by weight with potable water prior to passage of when used as a processing solvent. sugar liquor through the column. (2) Ammonolysis of natural tallow (ii) The residue of the additive in the fatty acids to form amines that are decolorized sugar liquor prior to crys- then reacted with 2-ethylhexanal, re- tallization shall not exceed 1 part per duced, methylated, and subsequently million of sugar as determined by a
137
VerDate 06
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 Drug, and Cosmetic Act, adequate di- the Act, the regulation would not be rections to assure use in compliance construed to relieve such use from with paragraph (c) of this section. compliance with section 402(a)(3). [56 FR 42686, Aug. 29, 1991] (c) The existence in this subchapter B of a regulation prescribing safe condi- tions for the use of a substance as an PART 174—INDIRECT FOOD article or component of articles that ADDITIVES: GENERAL contact food shall not be construed as implying that such substance may be Sec. safely used as a direct additive in food. 174.5 General provisions applicable to indi- rect food additives. (d) Substances that under conditions 174.6 Threshold of regulation for substances of good manufacturing practice may be used in food–contact articles. safely used as components of articles that contact food include the fol- AUTHORITY: 21 U.S.C. 321, 342, 348, 371. lowing, subject to any prescribed limi- § 174.5 General provisions applicable tations: to indirect food additives. (1) Substances generally recognized (a) Regulations prescribing condi- as safe in or on food. tions under which food additive sub- (2) Substances generally recognized stances may be safely used predicate as safe for their intended use in food usage under conditions of good manu- packaging. facturing practice. For the purpose of (3) Substances used in accordance this part and parts 175, 176, and 177 of with a prior sanction or approval. this chapter, good manufacturing prac- (4) Substances permitted for use by tice shall be defined to include the fol- regulations in this part and parts 175, lowing restrictions: 176, 177, 178 and § 179.45 of this chapter. (1) The quantity of any food additive [42 FR 14534, Mar. 15, 1977] substance that may be added to food as a result of use in articles that contact § 174.6 Threshold of regulation for food shall not exceed, where no limits substances used in food-contact ar- are specified, that which results from ticles. use of the substance in an amount not Substances used in food-contact arti- more than reasonably required to ac- cles (e.g., food-packaging or food-proc- complish the intended physical or tech- essing equipment) that migrate, or nical effect in the food-contact article; that may be expected to migrate, into shall not exceed any prescribed limita- food at negligible levels may be re- tions; and shall not be intended to ac- viewed under § 170.39 of this chapter. complish any physical or technical ef- The Food and Drug Administration fect in the food itself, except as such will exempt substances whose uses it may be permitted by regulations in determines meet the criteria in § 170.39 parts 170 through 189 of this chapter. of this chapter from regulation as food
138
VerDate 06
additives and, therefore, a food addi- (2) The adhesive is either separated tive petition will not be required for from the food by a functional barrier or the exempted use. used subject to the following additional [60 FR 36596, July 17, 1995] limitations: (i) In dry foods. The quantity of adhe- PART 175—INDIRECT FOOD ADDI- sive that contacts packaged dry food shall not exceed the limits of good TIVES: ADHESIVES AND COMPO- manufacturing practice. NENTS OF COATINGS (ii) In fatty and aqueous foods. (a) The quantity of adhesive that contacts Subpart A Reserved [ ] 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- aging laminates that may occur within Sec. the limits of good manufacturing prac- 175.105 Adhesives. tice. 175.125 Pressure-sensitive adhesives. (b) Under normal conditions of use Subpart C—Substances for Use as the packaging seams or laminates will Components of Coatings remain firmly bonded without visible separation. 175.210 Acrylate ester copolymer coating. (b) To assure safe usage of adhesives, 175.230 Hot-melt strippable food coatings. 175.250 Paraffin (synthetic). the label of the finished adhesive con- 175.260 Partial phosphoric acid esters of pol- tainer shall bear the statement ‘‘food- yester resins. packaging adhesive’’. 175.270 Poly(vinyl fluoride) resins. (c) Subject to any limitation pre- 175.300 Resinous and polymeric coatings. scribed in this section and in any other 175.320 Resinous and polymeric coatings for regulation promulgated under section polyolefin films. 175.350 Vinyl acetate/crotonic acid copoly- 409 of the Act which prescribes safe mer. conditions of use for substances that 175.360 Vinylidene chloride copolymer coat- may be employed as constituents of ad- ings for nylon film. hesives, the optional substances used 175.365 Vinylidene chloride copolymer coat- in the formulation of adhesives may in- ings for polycarbonate film. clude the following: 175.380 Xylene-formaldehyde resins con- densed with 4,4′-isopropylidenediphenol- (1) Substances generally recognized epichlorohydrin epoxy resins. as safe for use in food or food pack- 175.390 Zinc-silicon dioxide matrix coatings. aging. (2) Substances permitted for use in AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. adhesives by prior sanction or approval SOURCE: 42 FR 14534, Mar. 15, 1977, unless and employed under the specific condi- otherwise noted. tions of use prescribed by such sanc- EDITORIAL NOTE: Nomenclature changes to tion or approval. part 175 appear at 61 FR 14482, Apr. 2, 1996. (3) Flavoring substances permitted for use in food by regulations in this Subpart A [Reserved] part, provided that such flavoring sub- stances are volatilized from the adhe- Subpart B—Substances for Use sives during the packaging fabrication Only as Components of Adhesives process. (4) Color additives approved for use in § 175.105 Adhesives. food. (a) Adhesives may be safely used as (5) Substances permitted for use in components of articles intended for use adhesives by other regulations in this in packaging, transporting, or holding subchapter and substances named in food in accordance with the following this subparagraph: Provided, however, prescribed conditions: That any substance named in this (1) The adhesive is prepared from one paragraph and covered by a specific or more of the optional substances regulation in this subchapter, must named in paragraph (c) of this section, meet any specifications in such regula- subject to any prescribed limitations. tion.
139
VerDate 06
Substances Limitations
Abietic acid. Acetone. Acetone-formaldehyde condensate (CAS Reg. No. 25619±09±4). Acetone-urea-formaldehyde resin. N-Acetyl ethanolamine. Acetyl tributyl citrate. Acetyl triethyl citrate. Albumin, blood. (2-Alkenyl) succinic anhydrides in which the alkenyl groups are derived from olefins which contain not less than 78 percent C30 and higher groups (CAS Reg. No. 70983±55±0). 4-[2-[2-2-(Alkoxy (C12±C15) ethoxy) ethoxy]ethyl] disodium sulfosuccinate. 1-Alkyl (C6±C18) amino-3-amino-propane monoacetate. Alkylated (C4 and/or C8) phenols. Alkyl (C7±C12) benzene. Alkyl (C10±C20) dimethylbenzyl ammonium chloride. n-Alkyl(C12, C14, C16, or C18) dimethyl (ethylbenzyl) ammonium For use as preservative only. cyclohexylsulfamate. Alkyl ketene dimers as described in § 176.120 of this chapter. Alkyl (C7±C12) naphthalene. alpha Olefin sulfonate [alkyl group is in the range of C10±C18 with not less than 50 percent C14±C16], ammonium, calcium, magnesium, po- tassium, and sodium salts. 2-[(2-aminoethyl)amino]ethanol (CAS Reg. No. 111±41±1). 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. 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. 57569±40±1). 1,2±Benzisothiazolin±3±one (CAS Registry No. 2634±33±5) ...... For use as preservative only. Benzothiazyldisulfide. p-Benzoxyphenol ...... For use as preservative only. Benzoyl peroxide. Benzyl alcohol. Benzyl benzoate.
140
VerDate 06
Substances Limitations
Benzyl bromoacetate ...... For use as preservative only. p-Benzyloxyphenol ...... Do. BHA (butylated hydroxyanisole). BHT (butylated hydroxytoluene). Bicyclo[2.2.1]hept-2-ene-6-methyl acrylate. 2-Biphenyl diphenyl phosphate. Bis(benzoate-O)(2-propanolato)aluminum (CAS Reg. No. 105442±85±1) For use only as a reactant in the preparation of 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. 32687±78±8). 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. 17540±75±9). 2,6-Bis (1-methylheptadecyl)-p-cresol. 4-[[4, 6-Bis(octylthio)6-Bis(octylthio)6-Bis(octylthio)-s-triazin-2-yl]amino]- 2,6-di-tert-butylphenol (CAS Reg. No. 991±84±4). Bis(tri-n-butyltin) oxide ...... For use as preservative only. Bis(trichloromethyl)sulfone C.A. Registry No. 3064±70±8 ...... Do. Borax. Boric acid. 2-Bromo-2-nitro-1, 3-propanediol (CAS Reg. No. 52±51±7) ...... For use only as an antibacterial preservative. 1,3-Butanediol. 1,4-Butanediol. 1,4-Butanediol modified with adipic acid. Butoxy polyethylene polyproplyene glycol (molecular weight 900±4,200). Butyl acetate. Butyl acetyl ricinoleate. Butyl alcohol. Butylated reaction product of p-cresol and dicyclopentadiene ...... As identified in § 178.2010(b) of this chapter. Butylated, styrenated cresols identified in § 178.2010(b) of this chapter. Butyl benzoate. Butyl benzyl phthalate. Butyldecyl phthalate ...... 1,3-Butylene glycoldiglycolic acid copolymer. tert-Butyl hydroperoxide. 4,4′-Butylidenebis(6-tert-butyl-m-cresol). Butyl lactate. Butyloctyl phthalate. p-tert-Butylphenyl salicylate. Butyl phthalate butyl glycolate. p-tert-Butylpyrocatechol ...... For use only as polymerization-control agent. Butyl ricinoleate. Butyl rubber polymer. Butyl stearate. Butyl titanate, polymerized. Butyraldehyde. Calcium ethyl acetoacetate. Calcium nitrate. Calcium metasilicate. Camphor. Camphor fatty acid esters. Candelilla wax. epsilon-Caprolactam-(ethylene-ethyl acrylate) graft polymer. Carbon black, channel process. Carbon disulfide-1,1′-methylenedipiperidine reaction product. Carbon tetrachloride. Carboxymethylcellulose. Castor oil, polyoxyethylated (4±84 moles ethylene oxide). Cellulose acetate butyrate. Cellulose acetate propionate. Ceresin wax (ozocerite). Cetyl alcohol. Chloracetamide. Chloral hydrate. Chlorinated liquid n-paraffins with chain lengths of C10±C17, containing 40±70 percent chlorine by weight. Chlorinated pyridine mixture with active ingredients consisting of 2,3,5,6- For use as preservative only. tetrachloro-4-(methylsulfonyl) pyridine, 2,3,5,6-tetrachloro-4- (methylsulfinyl) pyridine and pentachloropyridine. Chlorinated rubber polymer (natural rubber polymer containing approxi- mately 67 percent chlorine). 1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride ...... For use as preservative only. Chlorobenzene.
141
VerDate 06
Substances Limitations
4-Chloro-3,5-dimethylphenol (p-chloro-m-xylenol) ...... For use as preservative only. 4-Chloro-3-methylphenol ...... Do. 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172±55±4) and For use only as an antimicrobial agent in polymer 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682±20±4) mixture at a latex emulsions. ratio of 3 parts to 1 part, manufactured from methyl-3- mercaptopropionate (CAS Reg. No. 2935±90±2). The mixture may contain magnesium nitrate (CAS Reg. No. 10377±60±3) at a 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. 35541±81±2). 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. 32760±80±8). Damar. Defoaming agents as described in § 176.210 of this chapter. Dehydroacetic acid ...... Diacetone alcohol. Diacetyl peroxide. N,N′-Dialkoyl-4,4′-diaminodiphenylmethane mixtures where; the alkoyl groups are derived from marine fatty acids (C12±C24). 2,5-Di-tert-amylhydroquinone. Diamines derived from dimerized vegetable oil acids. Diaryl-p-phenylenediamine, where the aryl group may be phenyl, tolyl, or xylyl. 1,2±Dibromo±2,4±dicyanobutane (CAS Registry No. 3569±65±7) ...... For use as a preservative only. 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.
142
VerDate 06
Substances Limitations
Diethyl phthalate. Dihexyl phthalate. Dihydroabietylphthalate. Di(2-hydroxy-5-tert-butylphenyl) sulfide. 2,2′-Dihydroxy-5,5′-dichlorodiphenylmethane (dichlorophene). 4,5-Dihydroxy-2-imidazolidinone. 4-(Diiodomethylsulfonyl) toluene CA Registry No.: 20018±09±01 ...... For use as an antifungal preservative only. Diisobutyl adipate. Diisobutyl ketone. Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride. Diisobutyl phthalate. Diisodecyl adipate. Diisodecyl phthalate. Diisooctyl phthalate. Diisopropylbenzene hydroperoxide. N,N-Dimethylcyclohexylamine dibutyldithiocarbamate. Dimethyl formamide. Dimethyl hexynol. 2,2-Dimethyl-1,3-propanediol dibenzoate. Dimethyl octynediol. N-(1,1-dimethyl-3-oxobutyl) acrylamide. Dimethyl phthalate. 3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione ...... For use as preservative only. Di-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...... Dipentene±styrene resin (CAS Registry No. 64536±06±7). Diphenyl-2-ethylhexyl phosphate. Diphenyl, hydrogen ated. N,N′-Diphenyl-p-phenylenediamine. Diphenyl phthalate. 1,3-Diphenyl-2-thiourea. Dipropylene glycol. Dipropylene glycol dibenzoate. Dipropylene glycol monomethyl ether. Dipropylene glycol copolymer of adipic acid and phthalic anhydride. Disodium cyanodithioimidocarbonate. Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294±49±8). N,N′-Distearoylethylenediamine. Distearyl thiodipropionate. 3,5-Di-tert-butyl-4-hydroxyhydrocinnamic acid triester with 1,3,5-tris(2-hy- For use as antioxidant only. droxyethyl)-s-triazine-2,4,6(1H, 3H, 5H)-trione. 4,4′-Dithiodimorpholine. n-Dodecylmercaptan. tert-Dodecylmercaptan. Dodecylphenoxybenzene-disulfonic acid and/or its calcium, magnesium, and sodium salts. Elemi gum. Epichlorohydrin-4,4′-isopropylidenediphenol resin. Epichlorohydrin-4,4′-sec-butylidenediphenol resin. Epichlorohydrin-4,4′-isopropylidene-di-o-cresol resin. Epichlorohydrin-phenolformaldehyde resin. Erucamide (erucylamide). Ethanolamine. Ethoxylated primary linear alcohols of greater than 10 percent ethylene oxide by weight having molecular weights of 390 to 7,000 (CAS Reg. No. 97953±22±5). Ethoxypropanol butyl ether. Ethyl alcohol (ethanol). 5-Ethyl-1,3-diglycidyl-5-methylhydantoin (CAS Reg. No. 15336±82±0). Ethylene-acrylic acid-carbon monoxide copolymer (CAS Reg. No. 97756±27±9). Ethylene-acrylic acid copolymer, partial sodium salt containing no more than 20 percent acrylic acid by weight, and no more than 16 percent of the acrylic acid as the sodium salt (CAS Reg. No. 25750±82±7).
143
VerDate 06
Substances Limitations
Ethylenediamine. Ethylenediaminetetra-acetic acid, calcium, ferric, potassium, or sodium salts, single or mixed. Ethylene dichloride. Ethylene glycol. Ethylene glycol monobutyl ether. Ethylene glycol monobutyl ether acetate. Ethylene glycol monoethyl ether. Ethylene glycol monoethyl ether acetate. Ethylene glycol monoethyl ether ricinoleate. Ethylene glycol monomethyl ether. Ethylene glycol monophenyl ether. Ethylene-carbon monoxide copolymer (CAS Reg. No. 25052±62±4) 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. 26221±73±8). Ethylene-propylene-dicyclopentadiene copolymer rubber. Ethylene, propylene, 1,4-hexadiene and 2,5-norbornadiene tetrapolymer. Ethylene-vinyl acetate carbon monoxide terpolymer (CAS Registry No. 26337±35±9) containing not more than 15 weight percent of units de- rived from carbon monoxide. 2,2′-Ethylidenebis (4,6-di-tert-butylphenol) (CAS Reg. No. 35958±30±6). Ethyl-p-hydroxybenzoate ...... For use as preservative only. Ethyl hydroxyethylcellulose. Ethyl lactate. 2,2′-Ethylidenebis(4,6-di-tert-butylphenyl)fluorophosphonite (CAS Reg. For use as an antioxidant and/or stabilizer only. No. 118337±09±0). Ethyl phthalyl ethyl glycolate. Ethyl-p-toluene sulfonamide ...... Fats and oils derived from animal or vegetable sources, and the hydro- genated, sulfated, or sulfonated forms of such fats and oils. Fatty acids derived from animal or vegetable fats and oils; and salts of such acids, single or mixed, as follows: Aluminum. Ammonium. Calcium. Magnesium. Potassium. Sodium. Zinc. Ferric chloride. Fluosilicic acid (hydrofluosilicic acid) ...... For use only as bonding agent for aluminum foil, 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. 13822±56±5). Glutaraldehyde. Glycerides, di- and monoesters. Glycerol polyoxypropylene triol, minimum average molecular weight 250 For use only in the preparation of polyester and poly- (CAS Reg. No. 25791±96±2). urethane resins in adhesives. Glyceryl borate (glycol boriborate resin). Glyceryl ester of damar, copal, elemi, and sandarac. Glyceryl monobutyl ricinoleate. Glyceryl monohydroxy stearate. Glyceryl monohydroxy tallowate. Glyceryl polyoxypropylene triol (average molecular weight 1,000). Glyceryl tribenzoate. Glycol diacetate. Glyoxal. Heptane. Hexamethylenetetramine.
144
VerDate 06
Substances Limitations
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. 68239±99±6). Hydrocarbon resins (produced by the polymerization of styrene and alpha-methyl styrene), hydrogenated (CAS Reg. No. 68441±37±2). Hydrofluoric acid ...... For use only as bonding agent for aluminum foil, 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. 106168±39±2). Hydrogenated dipentene-styrene copolymer resin (CAS Reg. No. 106168±36±9). Hydrogenated-beta-pinene-alpha-pinene-dipentene copolymer resin (CAS Reg. No. 106168±37±0). a-Hydro-omega-hydroxypoly-(oxytetramethylene) ...... For use only in the preparation of polyurethane res- ins. Hydroquinone. Hydroquinone monobenzyl ether. Hydroquinone monoethyl ether. 2(2′-Hydroxy-3′,5′ di-tert-amylphenyl) benzotriazole. Hydroxyacetic acid. 7-Hydroxycoumarin. Hydroxyethylcellulose. 2±Hydroxy-1-[4-(2-hydroxyethoxy)phenyl]-2-methyl-1-propanone(CAS For use only as a photoinitiator at a level not to ex- Reg. No. 106797±53±9). ceed 5 percent by weight of the adhesive. 1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2 alkyl (C6±C17) imidazolinium chlo- ride. Hydroxyethyldiethylenetriamine. β-Hydroxyethyl pyridinium 2-mercaptobenzothiazol. Hydroxyethyl starch. Hydroxyethylurea ...... Hydroxylamine sulfate. 5-Hydroxymethoxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, 5- For use only as an antibacterial preservative. hydroxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, and 5-hydroxypoly- [methyleneoxy]methyl-1-aza-3,7-dioxabicyclo[3.3.0] octane mixture. Hydroxypropyl methylcellulose. 2-(Hydroxymethyl)-2-methyl-1,3-propanediol tribenzoate. 2-Imidazolidinone. 3±Iodo±2±propynyl-N-butyl carbamate (CAS Reg. No. 55406±53±6) ...... For use only as an antifungal preservative. Iodoform ...... For use only as polymerization-control agent. Isoascorbic acid. Isobutyl alcohol (isobutanol). Isobutylene-isoprene copolymer. Isodecyl benzoate (CAS Reg. No. 131298±44±77). Isophorone. Isopropanolamine (mono-, di-, tri-). 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).
145
VerDate 06
Substances Limitations
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). 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) (1±2 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 6±9 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 1±40 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.
146
VerDate 06
Substances Limitations
Octylphenoxyethanols. Octylphenoxypolyethoxy-polypropoxyethanol (13 moles of ethylene oxide and propylene oxide). Odorless light petroleum hydrocarbons. Oleamide (oleic acid amide). Oleic acid, sulfated. 2,2′-Oxamidobis[ethyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate] (CAS Reg. No. 70331±94±1). Oxazoline. 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. 26142±30±3). 2,2'-[oxybis[(methyl-2,1-ethanediyl)-oxymethylene]]bisoxirane, (alternative For use as a reactant in the preparation of epoxy- name: epichlorohydrin-dipropylene glycol) (CAS Reg. No. 41638±13± based resins. 5). n-Oxydiethylene-benzothiazole. Palmitamide (palmitic acid amide). Paraffin (C12±C20) sulfonate. Paraformaldehyde. Pentachlorophenol. Pentaerythritol ester of maleic anhydride. Pentaerythritol monostearate ...... For use as preservative only. Pentaerythritol tetrabenzoate [CAS Registry No. 4196±86±5]. Pentaerythritol tetrastearate. 2,4-Pentanedione. Pentasodium diethylenetriaminepentaacetate (CAS Reg. No. 140±01±2). Perchloroethylene. Petrolatum. Petroleum hydrocarbon resin (cyclopentadiene type), hydrogenated. Petroleum hydrocarbon resin (produced by the catalytic polymerization and subsequent hydrogenation of styrene, vinyltoluene, and indene types from distillates of cracked petroleum stocks). Petroleum hydrocarbon resins (produced by the homo-and 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. 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. 9046±10±0). Poly(oxypropylene)diamine (weight average molecular weight 440) (CAS Reg. No. 9046±10±0). Tetraethylenepentamine. Triethylenetetramine. Polybutene, hydrogenated. Polybutylene glycol (molecular weight 1,000). Poly [2(diethylamino) ethyl methacrylate] phosphate. Polyester of adipic acid, phthalic acid, and propylene glycol, terminated with butyl alcohol. Polyester of diglycolic acid and propylene glycol containing ethylene gly- col monobutyl ether as a chain stopper.
147
VerDate 06
Substances Limitations
Polyester resins (including alkyd type), as the basic polymer, formed as esters when one or more of the following acids are made to react with one or more of the following alcohols: Acids: Azelaic acid. Dimethyl 1,4-cyclohexanedicarboxylate (CAS Reg. No. 94±60±0). Dimethyl-5-sulfoisophthalic acid (CAS Reg. No. 50975±82±1) and/or its sodium salt (CAS Reg. No. 3965±55±7). Polybasic and monobasic acids identified in § 175.300(b)(3)(vii)(a) and (b). 5-sulfo-1,3-benzenedicarboxylic acid, monosodium salt (CAS Reg. No. 6362±79±4). Tetrahydrophthalic acid. Alcohols: 1,4-Cyclohexanedimethanol. 2,2-Dimethyl-1,3-propanediol. 1,6-Hexanediol (CAS Reg. No. 629±11±8). Polyhydric and monohydric alcohols identified in § 175.300(b)(3)(vii)(c) and (d). Polyethyleneadipate modified with ethanolamine with the molar ratio of For use only in the preparation of polyurethan resins. the amine to the adipic acid less than 0.1 to 1. Polyethylene glycol (molecular weight 200±6,000). Polyethylene glycol mono-isotridecyl ether sulfate, sodium salt (CAS Reg. No. 150413±26±6). Polyethyleneglycol alkyl(C10±C12) ether sulfosuccinate, disodium salt (CAS Reg. No. 68954±91±6). Polyethylene, oxidized. Polyethylene resins, carboxyl modified, identified in § 177.1600 of this chapter. Polyethylenimine. Polyethylenimine-epichlorohydrin resins. Poly(ethyloxazoline) (CAS Reg. No. 25805-17-8). Polyisoprene. Polymeric esters of polyhydric alcohols and polycarboxylic acids 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. Polymers: Homopolymers and copolymers of the following monomers:. Acrylamide. Acrylic acid. Acrylonitrile. Allylmethacrylate (CAS Reg. No. 00096±05±09). Butadiene. Butene. N-tert-Butylacrylamide. Butyl acrylate. 1,3-Butylene glycol dimethacrylate. Butyl methacrylate. Crotonic acid. Decyl acrylate. Diallyl fumarate. Diallyl maleate. 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. Fumaric acid and/or its methyl, ethyl, propyl, butyl, amyl hexyl, heptyl and octyl esters. Glycidyl methacrylate. 1±Hexene (CAS Reg. No. 592±41±6). 2-Hydroxyethyl acrylate. 2-Hydroxyethyl methacrylate.
148
VerDate 06
Substances Limitations
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. 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). Poly(oxycaproyl) diols and triols (minimum molecular weight 500). Polyoxyethylated (40 moles) tallow alcohol sulfate, sodium salt. Polyoxyethylene (20 mol)Ðanhydrous lanolin adduct. Polyoxyethylene (molecular weight 200) dibenzoate. Polyoxyethylene (molecular weight 200±600) esters of fatty acids derived from animal or vegetable fats and oils (including tall oil). Polyoxyethylene (15 moles) ester of rosin. Polyoxyethylene (4±5 moles) ether of phenol. Polyoxyethylene (25 moles)Ðglycerol adduct. Polyoxyethylene (40 moles) stearate. Polyoxyethylene (5±15 moles) tridecyl alcohol. Polyoxypropylene (3 moles) tridecyl alcohol sulfate. Polyoxypropylene (20 moles) butyl ether. Polyoxypropylene (40 moles) butyl ether. Polyoxypropylene (20 moles) oleate butyl ether. Polyoxypropylene-polyoxyethylene condensate (minimum molecular weight 1,900). Polypropylene glycol (minimum molecular weight 150). Polypropylene glycol (3±4 moles) triether with 2-ethyl-2-(hydroxymethyl)- 1,3-propane-diol, average molecular weight 730. Polypropylene glycol dibenzoate (CAS Reg. No. 72245±46±6) ...... For use as a plasticizer at levels not to exceed 20 percent by weight of the finished adhesive. Polypropylene, noncrystalline. Polysiloxanes: Diethyl polysiloxane. Dihydrogen polysiloxane. Dimethyl polysiloxane. Diphenyl polysiloxane. Ethyl hydrogen polysiloxane. Ethyl phenyl polysiloxane. Methyl ethyl polysiloxane. Methyl hydrogen polysiloxane. Methyl phenyl polysiloxane. Phenyl hydrogen polysiloxane. Polysorbate 60. Polysorbate 80. Polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate).
149
VerDate 06
Substances Limitations
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. 5124±30±1) with: (i) one or more of the polyols or polyesters named in this paragraph and with either N-methyldiethanolamine (CAS Reg. No. 105±59±9) and dimethyl sulfate (CAS Reg. No. 77±78±1) or dimethylolpropionic acid (CAS Reg. No. 4767±03±7) and triethylamine (CAS Reg. No. 121±44±8), or (ii) a fumaric acid-modified poly- propylene glycol or fumaric acid-modified tripropylene glycol), triethylamine (CAS Reg. No. 107±15±3), and ethylenediamine (CAS Reg. No. 121±44±8), or (4) reacting meta-tetramethylxylene diisocyanate (CAS Reg. No. 2778±42±9) with one or more of the polyols and polyesters listed in this paragraph and with dimethylolpropionic acid (CAS Reg. No. 4767±03±7) and triethylamine (CAS Reg. No. 121±44±8), N-methyldiethanolamine (CAS Reg. No. 105±59±9), 2±dimethylaminoethanol (CAS Reg. No. 108±01±0), 2± dimethylamino±2±methyl±1±propanol (CAS Reg. No. 7005±47±2), and/or 2±amino±2±methyl±1±propanol (CAS Reg. No. 124±68±5). Polyvinyl alcohol modified so as to contain not more than 3 weight 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. 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. 19224±26±1) ...... For use as a plasticizer at levels not to exceed 20 percent by weight of the finished adhesive. Propylene glycol esters of coconut fatty acids. Propylene glycol monolaurate. Propylene glycol monomethyl ether. Propylene glycol monostearate. 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 (C1±C9) phenolformaldehyde. Ammonia. Ammonium caseinate-p-Cyclohexylphenolformaldehyde. Diethylene glycol. Dipentaerythritol. Ethylene glycol. Formaldehyde. Fumaric acid. Glycerin. Hydrogen. Isophthalic acid. 4,4′-Isopropylidenediphenol-epichlorohydrin (epoxy). 4,4′-Isopropylidenediphenol-formaldehyde. Maleic anhydride. Methyl alcohol. Pentaerythritol. Phthalic anhydride. Polyethylene glycol. Phenol-formaldehyde.
150
VerDate 06
Substances Limitations
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 (C2±C13.5 aliphatic) benezenesulfonate. Sodium aluminum pyrophosphate. Sodium aluminum sulfate. Sodium bisulfate. Sodium calcium silicate. Sodium capryl polyphosphate. Sodium carboxymethylcellulose. Sodium chlorate. Sodium chlorite. Sodium chromate. Sodium decylsulfate. Sodium dehydroacetate ...... For use as preservative only. Sodium di-(2-ethylhexoate). Sodium di-(2-ethylhexyl) pyrophosphate. Sodium dihexylsulfosuccinate. Sodium dissobutylphenoxydiethoxyethyl sulfonate. Sodium diisobutylphenoxymonoethoxyethyl sulfonate. Sodium diisopropyl- and triisopropylnaphthalenesulfonate. Sodium dimethyldithiocarbamate. Sodium dioctylsulfosuccinate. Sodium n-dodecylpolyethoxy (50 moles) sulfate. Sodium ethylene ether of nonylphenol sulfate. Sodium 2-ethylhexyl sulfate. Sodium fluoride ...... For use only as bonding agent for aluminum foil, 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.
151
VerDate 06
Substances Limitations
Sorbitan monostearate. Soybean oil, epoxidized. Spermaceti wax. Sperm oil wax. Stannous 2-ethylhexanoate ...... For use only as a catalyst for polyurethane resins. Stannous stearate. Starch hydrolysates. Starch or starch modified by one or more of the treatments described in §§ 172.892 and 178.3520 of this chapter. Starch, reacted with a urea-formaldehyde resin. Starch, reacted with formaldehyde. Stearamide (stearic acid amide). Stearic acid. Stearic acid-chromic chloride complex. Stearyl-cetyl alcohol, technical grade, approximately 65 percent±80 per- cent stearyl and 20 percent±35 percent cetyl. Strontium salicylate. Styrenated phenol. Styrene block polymers with 1,3-butadiene. Styrene-maleic anhydride copolymer, ammonium or potassium salt. Styrene-maleic anhydride copolymer (partially methylated) sodium salt. Styrene-methacrylic acid copolymer, potassium salt. Sucrose acetate isobutyrate. Sucrose benzoate. Sucrose octaacetate. 2±sulfoethyl methacrylate (CAS Registry No. 10595±80±9) ...... For use at levels not to exceed 2 percent by weight of the dry adhesive. 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 5±6 moles of ethylene oxide, Chemical Abstracts Service Registry No. 039354±45±5). 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 9±10 moles of ethylene oxide) (CAS Reg. No. 9040±38±4). Sulfur. Synthetic primary linear aliphatic alcohols whose weight average molec- ular weight is greater than 400 (CAS Reg. No. 71750±71±5). Synthetic wax polymer as described in § 176.170(a)(5) of this chapter. Tall oil. Tall oil fatty acids, linoleic and oleic. Tall oil fatty acid methyl ester. Tall oil, methyl ester. Tall oil pitch. Tall oil soaps. Tallow alcohol (hydrogenated). Tallow amine, secondary (hexadecyl, octadecyl), of hard tallow. Tallow, blown (oxidized). Tallow, propylene glycol ester. 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 1±40 moles of ethylene oxide. A-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxy-poly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and their sodium, potassium, and ammonium salts having a poly(oxyethylene) content averaging 6±9 or 40 moles. Tetramethyl decanediol. Tetramethyl decynediol. Tetramethyl decynediol plus 1±30 moles of ethylene oxide. Tetramethylthiuram monosulfide.
152
VerDate 06
Substances Limitations
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. 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. 139± 89±9). Turpentine. Urea-formaldehyde resins as described in § 175.300(b)(3)(xii). Vegetable oil, sulfonated or sulfated, potassium salt. Vinyl acetate-maleic anhydride copolymer, sodium salt. Waxes, petroleum. Wax, petroleum, chlorinated (40% to 70% chlorine). Waxes, synthetic paraffin (Fischer-Tropsch process). 3-(2-Xenolyl)-1,2-epoxypropane. Xylene. Xylene (or toluene) alkylated with dicyclopentadiene. Zein. Zinc acetate. Zinc ammonium chloride. Zinc dibenzyl dithiocarbamate. Zinc dibutyldithiocarbamate. Zinc diethyldithiocarbamate. Zinc di(2-ethylhexoate). Zinc formaldehyde sulfoxylate. Zinc naphthenate and dehydroabietylamine mixture.
153
VerDate 06
Substances Limitations
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 in the Finding Aids section of this volume.
§ 175.125 Pressure-sensitive adhesives. (b) Pressure-sensitive adhesives pre- pared from one or a mixture of two or Pressure-sensitive adhesives may be more of the substances listed in this safely used as the food-contact surface paragraph may be used as the food-con- of labels and/or tapes applied to food, tact surface of labels and/or tapes ap- in accordance with the following pre- plied to raw fruit and raw vegetables. scribed conditions: (1) Substances listed in paragraphs (a) Pressure-sensitive adhesives pre- (a)(1), (a)(2), (a)(3), (a)(5), (a)(6), (a)(7), pared from one or a mixture of two or and (a)(8) of this section, and those more of the substances listed in this substances prescribed by paragraph paragraph may be used as the food-con- (a)(4) of this section that are not iden- tact surface of labels and/or tapes ap- tified in paragraph (b)(2) of this sec- plied to poultry, dry food, and proc- tion. essed, frozen, dried, or partially dehy- (2) Substances identified in this sub- drated fruits or vegetables. paragraph and subject to the limita- (1) Substances generally recognized tions provided: as safe in food. (2) Substances used in accordance BHA. with a prior sanction or approval. BHT. Butadiene-acrylonitrile copolymer. (3) Color additives listed for use in or Butadiene-acrylonitrile-styrene copolymer. on food in parts 73 and 74 of this chap- Butadiene-styrene copolymer. ter. Butyl rubber. (4) Substances identified in § 172.615 of Chlorinated natural rubber. this chapter other than substances Isobutylene-styrene copolymer. used in accordance with paragraph Petrolatum. Polybutene-1. (a)(2) of this section. Polybutene, hydrogenated; complying with (5) Polyethylene, oxidized; complying the identity prescribed under § 178.3740(b) of with the identity prescribed in this chapter. § 177.1620(a) of this chapter. Polyisobutylene. (6) 4-[[4, 6-Bis(octylthio)-s-triazin-2- cis-1,4-Polyisoprene. yl]amino]-2,6-di-tert-butylphenol (CAS Polystyrene. Propyl gallate. Reg. No. 991–84–4) as an antioxidant/ Rapeseed oil, vulcanized. stabilizer at a level not to exceed 1.5 Rosins and rosin derivatives as provided in percent by weight of the finished pres- § 178.3870 of this chapter. sure-sensitive adhesive. Rubber hydrochloride. (7) 2,2′-(2,5-Thiophenediyl)-bis(5-tert- Rubber (natural latex solids or crepe, butylbenzoxazole) (CAS Reg. No. 7128– smoked or unsmoked). α β 64–5) as an optical brightener at a level Terpene resins ( - and -pinene), homopolymers, copolymers, and conden- not to exceed 0.05 percent by weight of sates with phenol, formaldehyde, cou- the finished pressure-sensitive adhe- marone, and/or indene. sive. Tetrasodium ethylenediaminetetraacetate. (8) 2-Hydroxy-1-[4-(2- Tri(mixed mono- and dinonylphenyl) hydroxyethoxy)phenyl]-2-methyl-1- phosphite (which may contain not more propanone (CAS Reg. No. 106797–53–9) as than 1 percent by weight of a photoinitiator at a level not to ex- triisopropanolamine). ceed 5 percent by weight of the pres- (c) Acrylonitrile copolymers identi- sure-sensitive adhesive. fied in this section shall comply with
154
VerDate 06
the provisions of § 180.22 of this chap- minutes shall yield total chloroform- ter. soluble extractables not to exceed 0.5 milligram per square inch. [42 FR 14534, Mar. 15, 1977, as amended at 42 (2) An appropriate sample when ex- FR 15674, Mar. 22, 1977; 48 FR 15617, Apr. 12, ° 1983; 63 FR 3464, Jan. 23, 1998; 63 FR 51528, posed to n-heptane at 120 F for 30 min- Sept. 28, 1998] utes shall yield total chloroform-solu- ble extractables not to exceed 0.5 milli- Subpart C—Substances for Use as gram per square inch. Components of Coatings § 175.230 Hot-melt strippable food coatings. § 175.210 Acrylate ester copolymer coating. Hot-melt strippable food coatings may be safely applied to food, subject Acrylate ester copolymer coating to the provisions of this section. may safely be used as a food-contact (a) The coatings are applied to and surface of articles intended for pack- used as removable coatings for food. aging and holding food, including heat- (b) The coatings may be prepared, as ing of prepared food, subject to the pro- mixtures, from the following sub- visions of this section: stances: (a) The acrylate ester copolymer is a (1) Substances generally recognized fully polymerized copolymer of ethyl as safe in food. acrylate, methyl methacrylate, and (2) Substances identified in this sub- methacrylic acid applied in emulsion paragraph. form to molded virgin fiber and heat- cured to an insoluble resin. List of substances Limitations (b) Optional substances used in the Acetylated monoglycerides ...... Complying with 172.828 preparation of the polymer and in the of this chapter. preparation and application of the Cellulose acetate butyrate. Cellulose acetate propionate. emulsion may include substances Mineral oil, white ...... For use only as a com- named in this paragraph, in an amount ponent of hot-melt not to exceed that required to accom- strippable food coat- plish the desired technical effect and ings applied to frozen meats and complying subject to any limitation prescribed: with § 172.878 of this Provided, however, That any substance chapter. named in this paragraph and covered by a specific regulation in subchapter § 175.250 Paraffin (synthetic). B of this chapter must meet any speci- Synthetic paraffin may be safely fications in such regulation. used as an impregnant in, coating on, List of substances Limitations or component of coatings on articles used in producing, manufacturing, Aluminum stearate. packing, processing, preparing, treat- Ammonium lauryl sulfate. Borax ...... Not to exceed the ing, packaging, transporting, or hold- amount required as a ing food in accordance with the fol- preservative in emul- lowing prescribed conditions: sion defoamer. Disodium hydrogen phosphate ..... Do. (a) The additive is synthesized by the Formaldehyde. Fischer-Tropsch process from carbon Glyceryl monostearate. monoxide and hydrogen, which are cat- Methyl cellulose. alytically converted to a mixture of Mineral oil. Paraffin wax. paraffin hydrocarbons. Lower molec- Potassium hydroxide. ular-weight fractions are removed by Potassium persulfate. distillation. The residue is hydro- Tallow. Tetrasodium pyrophosphate. genated and may be further treated by 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.
155
VerDate 06
(b) Synthetic paraffin shall conform § 175.260 Partial phosphoric acid to the following specifications: esters of polyester resins. (1) Congealing point. There is no speci- Partial phosphoric acid esters of pol- fication for the congealing point of yester resins identified in this section synthetic paraffin components, except and applied on aluminum may be safely those components that have a con- used as food-contact coatings, in ac- gealing point below 50 °C when used in cordance with the following prescribed contact with food Types III, IVA, V, conditions: VIIA, and IX identified in table 1 of (a) For the purpose of this section, § 176.170(c) of this chapter and under partial phosphoric acid esters of poly- conditions of use E, F, and G described ester resins are prepared by the reac- in table 2 of § 176.170(c) of this chapter tion of trimellitic anhydride with 2,2- shall be limited to a concentration not dimethyl-1,3-propanediol followed by reaction of the resin thus produced exceeding 15 percent by weight of the with phosphoric acid anhydride to finished coating. The congealing point produce a resin having an acid number shall be determined by ASTM method of 81 to 98 and a phosphorus content of D938–71 (Reapproved 1981), ‘‘Standard 4.05 to 4.65 percent by weight. Test Method for Congealing Point of (b) The coating is chemically bonded Petroleum Waxes, Including Petro- to the metal and cured at temperatures latum,’’ which is incorporated by ref- exceeding 450 °F. erence. Copies may be obtained from (c) The finished food-contact coating, the American Society for Testing Ma- when extracted with the solvent or sol- terials, 1916 Race St., Philadelphia, PA vents characterizing the type of food 19103, or may be examined at the Office and under the conditions of time and of the Federal Register, 800 North Cap- temperature characterizing the condi- itol Street, NW., suite 700, Washington, tions of its intended use, as determined DC 20408. from tables 1 and 2 of § 175.300(d), yields (2) Oil content. The substance has an total extractives in each extracting oil content not exceeding 2.5 percent as solvent not to exceed 0.3 milligrams determined by ASTM method D721–56T, per square inch of food-contact surface, as determined by the methods de- ‘‘Tentative Method of Test for Oil Con- scribed in § 175.300(e), and the coating tent of Petroleum Waxes’’ (Revised yields 2,2-dimethyl-1,3-propanediol in 1956), which is incorporated by ref- each extracting solvent not to exceed erence. See paragraph (b)(1) of this sec- 0.3 micrograms per square inch of food- tion for availability of the incorpora- contact surface. In testing the finished tion by reference. food-contact articles, a separate test (3) Absorptivity. The substance has an sample is to be used for each required absorptivity at 290 millimicrons in extracting solvent. decahydronaphthalene at 88 °C not ex- ceeding 0.01 as determined by ASTM § 175.270 Poly(vinyl fluoride) resins. method E131–81a, ‘‘Standard Defini- Poly(vinyl fluoride) resins identified tions of Terms and Symbols Relating in this section may be safely used as to Molecular-Spectroscopy,’’ which is components of food-contact coatings incorporated by reference. See para- for containers having a capacity of not graph (b)(1) of this section for avail- less than 5 gallons, subject to the pro- ability of the incorporation by ref- visions of this section. erence. (a) For the purpose of this section, (c) The provisions of this section are poly(vinyl fluoride) resins consist of basic resins produced by the polym- not applicable to synthetic paraffin erization of vinyl fluoride. used in food-packaging adhesives com- (b) The poly(vinyl fluoride) basic res- plying with § 175.105. ins have an intrinsic viscosity of not [42 FR 14534, Mar. 15, 1977, as amended at 47 less than 0.75 deciliter per gram as de- FR 11839, Mar. 19, 1982; 49 FR 10106, Mar. 19, termined by ASTM method D1243–79, 1984; 51 FR 47010, Dec. 30, 1986; 60 FR 39645, ‘‘Standard Test Method for Dilute So- Aug. 3, 1995] lution Viscosity of Vinyl Chloride
156
VerDate 06
Polymers,’’ which is incorporated by repeated food-contact use and is ap- reference. Copies may be obtained from plied to any suitable substrate as a the American Society for Testing Ma- continuous film or enamel that serves terials, 1916 Race St., Philadelphia, PA as a functional barrier between the 19103, or may be examined at the Office food and the substrate. The coating is of the Federal Register, 800 North Cap- characterized by one or more of the fol- itol Street, NW., suite 700, Washington, lowing descriptions: DC 20408. (1) Coatings cured by oxidation. (1) Solvent. N,N-Dimethylacetamide, (2) Coatings cured by polymerization, technical grade. condensation, and/or cross-linking (2) Solution. Powdered resin and sol- without oxidation. vent are heated at 120 °C until the resin (3) Coatings prepared from prepoly- is dissolved. merized substances. (3) Temperature. Flow times of the (b) The coatings are formulated from solvent and solution are determined at optional substances that may include: 110 °C. (1) Substances generally recognized (4) Viscometer. Cannon-Ubbelohde size as safe in food. 50 semimicro dilution viscometer (or (2) Substances the use of which is equivalent). permitted by regulations in this part (5) Calculation. The calculation meth- or which are permitted by prior sanc- od used is that described in appendix X tion or approval and employed under 1.3 (ASTM method D1243–79, ‘‘Standard the specific conditions, if any, of the Test Method for Dilute Solution Vis- prior sanction or approval. cosity of Vinyl Chloride Polymers,’’ (3) Any substance employed in the which is incorporated by reference; see production of resinous and polymeric paragraph (b) of this section for avail- coatings that is the subject of a regula- ability of the incorporation by ref- tion in subchapter B of this chapter erence) with the reduced viscosity de- and conforms with any specification in termined for three concentration levels such regulation. Substances named in not greater than 0.5 gram per deciliter this paragraph (b)(3) and further identi- and extrapolated to zero concentration fied as required: for intrinsic viscosity. The following (i) Drying oils, including the formula is used for determining re- triglycerides or fatty acids derived duced viscosity: therefrom: Reduced viscosity in terms t− to Beechnut. = Candlenut. of deciliters per gram to× c Castor (including dehydrated). where: Chinawood (tung). t=Solution efflux time. Coconut. to=Solvent efflux time. Corn. c=Concentration of solution in terms of Cottonseed. grams per deciliter. Fish (refined). [42 FR 14534, Mar. 15, 1977, as amended at 47 Hempseed. FR 11839, Mar. 19, 1982; 49 FR 10107, Mar. 19, Linseed. 1984] Oiticica. Perilla. § 175.300 Resinous and polymeric coat- Poppyseed. ings. Pumpkinseed. Resinous and polymeric coatings Safflower. may be safely used as the food-contact Sesame. surface of articles intended for use in Soybean. Sunflower. producing, manufacturing, packing, Tall oil. processing, preparing, treating, pack- Walnut. aging, transporting, or holding food, in accordance with the following pre- The oils may be raw, heat-bodied, or scribed conditions: blown. They may be refined by filtra- (a) The coating is applied as a contin- tion, degumming, acid or alkali wash- uous film or enamel over a metal sub- ing, bleaching, distillation, partial de- strate, or the coating is intended for hydration, partial polymerization, or
157
VerDate 06
solvent extraction, or modified by com- (c) Rosin esters (paragraph (b)(3)(v)(b) bination with maleic anhydride. of this section) modified by reaction (ii) Reconstituted oils from with: triglycerides or fatty acids derived Maleic anhydride. from the oils listed in paragraph o-, m-, and p-substituted phenol-formalde- (b)(3)(i) of this section to form esters hydes listed in paragraph (b)(3)(vi) of this with: section. Phenol-formaldehyde. Butylene glycol. Ethylene glycol. (d) Rosin salts: Pentaerythritol. Calcium resinate (limed rosin). Polyethylene glycol. Zinc resinate. Polypropylene glycol. Propylene glycol. (vi) Phenolic resins as the basic poly- Sorbitol. mer formed by reaction of phenols with Trimethylol ethane. formaldehyde: Trimethylol propane. (a) Phenolic resins formed by reac- (iii) Synthetic drying oils, as the tion of formaldehyde with: basic polymer: Alkylated (methyl, ethyl, propyl, isopropyl, butyl) phenols. Butadiene and methylstyrene copolymer. p-tert-Amylphenol. Butadiene and styrene copolymer, blown or 4,4′-sec-Butylidenediphenol. unblown. p-tert-Butylphenol. Maleic anhydride adduct of butadiene sty- o-, m-, and p-Cresol. rene. p-Cyclohexylphenol. Polybutadiene. 4,4′-Isopropylidenediphenol. (iv) Natural fossil resins, as the basic p-Nonylphenol. p-Octylphenol. resin: 3-Pentadecyl phenol mixture obtained from Copal. cashew nut shell liquid. Damar. Phenol. Phenyl o-cresol. Elemi. p-Phenylphenol. Gilsonite. Xylenol. Glycerol ester of damar, copal, elemi, and sandarac. (b) Adjunct for phenolic resins: Alu- Sandarac. minum butylate. Shellac. (vii) Polyester resins (including Utah coal resin. alkyd-type), as the basic polymers, (v) Rosins and rosin derivatives, with formed as esters of acids listed in para- or without modification by polymeriza- graph (b)(3)(vii) (a) and (b) of this sec- tion, isomerization, incidental tion by reaction with alcohols in para- decarboxylation, and/or hydrogenation, graph (b)(3)(vii) (c) and (d) of this sec- as follows: tion. (a) Rosins, refined to color grade of K (a) Polybasic acids: or paler: Adipic. Gum rosin. 1,4-cyclohexanedicarboxylic (CAS Reg. No. Tall oil rosin. 1076–97–7). Dimerized fatty acids derived from oils listed Wood rosin. 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. 2,6-Naphthalenedicarboxylic. 4,4′-sec-Butylidenediphenol-epichlorohydrin 2,6-Naphthalenedicarboxylic, dimethyl ester. (epoxy). Orthophthalic. Diethylene glycol. Sebacic. Ethylene glycol. Terephthalic. Glycerol. Terpene-maleic acid adduct. 4,4′-Isopropylidenediphenol-epichlorohydrin Trimellitic. (epoxy). (b) Monobasic acids: Methyl alcohol. Pentaerythritol. Benzoic acid.
158
VerDate 06
4,4-Bis(4′-hydroxyphenyl)-pentanoic acid. or fatty acids listed in paragraph (b)(3)(i) tert-Butyl benzoic acid. of this section. Fatty acids derived from oils listed in para- 4,4′-sec-Butylidenediphenol-epichlorohydrin graph (b)(3)(i) of this section. chemically treated with one or more of Rosins listed in paragraph (b)(3)(v)(a) of this the following substances: section, for use only as reactants in oil- Allyl ether of mono-, di-, or trimethylol based or fatty acid-based alkyd resins. phenol. ′ (c) Polyhydric alcohols: 4,4 -sec-Butylidenediphenol-formaldehyde. 4,4′-Isopropylidenediphenol-formaldehyde. Butylene glycol. Melamine-formaldehyde. Diethylene glycol. Phenol-formaldehyde. 2,2-Dimethyl-1,3-propanediol for use only in Urea-formaldehyde. forming polyester resins for coatings in- Epoxidized polybutadiene. tended for use in contact with non-alco- Glycidyl ethers formed by reacting holic foods. phenolnovolak resins with Ethylene glycol. epichlorohydrin. Glycerol. 4,4′-Isopropylidenediphenol-epichlorohydrin. Mannitol. 4,4′-Isopropylidenediphenol-epichlorohydrin α-Methyl glucoside. reacted with one or more of the drying oils Pentaerythritol. or fatty acids listed in paragraph (b)(3)(i) Propylene glycol. of this section. Sorbitol. 4,4′-Isopropylidenediphenol-epichlorohydrin Triethylene glycol, for use as a component in chemically treated with one or more of polyester resins for coatings not exceeding the following substances: a coating weight of 4 milligrams per square Allyl ether of mono-, di-, or trimethylol inch and that are intended for contact phenol. under conditions of use D, E, F or G de- 4,4′-sec-Butylidenediphenol-formaldehyde. scribed in table 2 of paragraph (d) of this 4,4′-Isopropylidenediphenol-formaldehyde. section with alcoholic beverages con- Melamine-formaldehyde. taining less than 8 percent alcohol. Phenol-formaldehyde. Trimethylol ethane. Urea-formaldehyde. Trimethylol propane. (b) Catalysts and cross-linking agents (d) Monohydric alcohols: for epoxy resins: Cetyl alcohol. 3-(Aminomethyl)-3,5,5-trimethylcyclohexyl- Decyl alcohol. Lauryl alcohol. amine reacted with phenol and formalde- Myristyl alcohol. hyde in a ratio of 2.6:1.0:2.0, for use only in Octyl alcohol. coatings intended for repeated use in con- Stearyl alcohol. tact with foods only of the types identified in paragraph (d) of this section, table 1, (e) Catalysts: under Category I and Category VIII, at temperatures not exceeding 88 °C (190 °F). Dibutyltin oxide (CAS Reg. No. 818–08–6), not N-Beta-(aminoethyl)-gamma-aminopropyltri- to exceed 0.2 percent of the polyester resin. methoxysilane (CAS Reg. No. 1760–24–3), for Hydroxybutyltin oxide (CAS Reg. No. 2273– use only in coatings at a level not to ex- 43–0), not to exceed 0.2 percent of the poly- ceed 1.3 percent by weight of the resin ester resin. when such coatings are intended for re- Monobutyltin tris(2-ethylhexoate) (CAS Reg. peated use in contact with foods only of No. 23850–94–4), not to exceed 0.2 percent of the types identified in paragraph (d) of this the polyester resin. section, table 1, under Types I, II, and III, (viii) Epoxy resins, catalysts, and ad- under conditions of use C, D, E, or F as de- juncts: scribed in table 2 of paragraph (d) of this (a) Epoxy resins, as the basic poly- section; or when such coatings are in- mer: tended for repeated use in contact with foods of the types identified in paragraph (Alkoxy C10–C16)-2,3-epoxypropane, in which (d) of this section, table 1, under Types V, the alkyl groups are even numbered and VI, VII, and VIII, under conditions of use E consist of a maximum of 1 percent C10 car- or F as described in table 2 of paragraph (d) bon atoms and a minimum of 48 percent C12 of this section. Use shall be limited to carbon atoms and a minimum of 18 percent coatings for tanks of capacity greater than C14 carbon atoms, for use only in coatings 530,000 gallons. that are intended for contact with dry bulk Benzyl alcohol (CAS Reg. No. 100–51–6), for foods at room temperature. use only in coatings at a level not to ex- 4,4′-sec-Butylidenediphenol-epichlorohydrin. ceed 4 percent by weight of the resin when 4,4′-sec-Butylidenediphenol-epichlorohydrin such coatings are intended for repeated use reacted with one or more of the drying oils in contact with foods only of the types
159
VerDate 06
identified in paragraph (d) of this section, for use only in coatings that are subject to table 1, under Types I, II, and III, under the provisions of paragraph (c) (3) or (4) of conditions of use C, D, E, or F as described this section and that contact food at tem- in table 2 of paragraph (d) of this section; peratures not to exceed room temperature. or when such coatings are intended for re- Salicylic acid, for use only in coatings for peated use in contact with foods of the containers having a capacity of 1,000 gal- types identified in paragraph (d) of this lons or more when such containers are in- section, table 1, under Types V, VI, VII, tended for repeated use in contact with al- and VIII, under conditions of use E or F as coholic beverages containing up to 8 per- described in table 2 of paragraph (d) of this cent of alcohol by volume. section. Use shall be limited to coatings Salicylic acid (CAS Reg. No. 69–72–7), for use for tanks of capacity greater than 530,000 only in coatings at a level not to exceed gallons. 0.35 percent by weight of the resin when Catalysts and cross-linking agents for epoxy such coatings are intended for repeated use resins: in contact with foods only of the types 3-Aminomethyl-3,5,5- identified in paragraph (d) of this section, trimethylcyclohexylamine (CAS Reg. No. table 1, under Types I, II, and III, under 2855–0913–092). conditions of use C, D, E, or F as described Cyanoguanidine. in table 2 of paragraph (d) of this section; Dibutyl phthalate, for use only in coatings or when such coatings are intended for re- for containers having a capacity of 1,000 peated use in contact with foods of the gallons or more when such containers are types identified in paragraph (d) of this intended for repeated use in contact with section, table 1, under Types V, VI, VII, alcoholic beverages containing up to 8 per- and VIII, under conditions of use E or F as cent of alcohol by volume. described in table 2 of paragraph (d) of this 3-Diethylaminopropylamine (CAS Reg. No. section. Use shall be limited to coatings 104–78–9), for use in coatings at a level not for tanks of capacity greater than 530,000 to exceed 6 percent by weight of the resin gallons. when such coatings are intended for re- Stannous 2-ethylhexanoate for use only as a peated use in contact with foods only of catalyst at a level not to exceed 1 percent the types identified in paragraph (d) of this by weight of the resin used in coatings that section, table 1, under Types I, II, and III, are intended for contact with food under under conditions of use C, D, E, or F as de- conditions of use D, E, F, and G described scribed in table 2 of paragraph (d) of this in table 2 of paragraph (d) of this section. section; or when such coatings are in- Styrene oxide, for use only in coatings for tended for repeated use in contact with containers having a capacity of 1,000 gal- foods of the types identified in paragraph lons or more when such containers are in- (d) of this section, table 1, under Types V, tended for repeated use in contact with al- VI, VII, and VIII, under conditions of use E coholic beverages containing up to 8 per- or F as described in table 2 of paragraph (d) cent of alcohol by volume. of this section. Use shall be limited to Tetraethylenepentamine. coatings for tanks of capacity greater than Tetraethylenepentamine reacted with 530,000 gallons. equimolar quantities of fatty acids. Diethylenetriamine. Tri(dimethylaminomethyl) phenol and its Diphenylamine. salts prepared from the fatty acid moieties Ethylenediamine. of the salts listed in paragraph Isophthalyl dihydrazide for use only in coat- (b)(3)(xxii)(b) of this section, for use only ings subject to the provisions of paragraph in coatings subject to the provisions of (c) (3) or (4) of this section. paragraph (c) (3) or (4) of this section. 4,4′-Methylenedianiline, for use only in coat- Triethylenetetramine. ings for containers having a capacity of Trimellitic anhydride (CAS Reg. No. 552–30– 1,000 gallons or more when such containers 7) for use only as a cross-linking agent at are intended for repeated use in contact a level not to exceed 15 percent by weight with alcoholic beverages containing up to 8 of the resin in contact with food under all percent of alcohol by volume. conditions of use, except that resins in- N-Oleyl-1,3-propanediamine with not more tended for use with foods containing more than 10 percent by weight of than 8 percent alcohol must contact such diethylaminoethanol. food only under conditions of use D, E, F, 3-Pentadecenyl phenol mixture (obtained and G described in table 2 of paragraph (d) from cashew nutshell liquid) reacted with of this section. formaldehyde and ethylenediamine in a Trimellitic anhydride adducts of ethylene ratio of 1:2:2 (CAS Reg. No. 68413–28–5). glycol and glycerol, prepared by the reac- Polyamine produced when 1 mole of the tion of 1 mole of trimellitic anhydride with chlorohydrin diether of polyethylene gly- 0.4–0.6 mole of ethylene glycol and 0.04–0.12 col 400 is made to react under mole of glycerol, for use only as a cross- dehydrohalogenating conditions with 2 linking agent at a level not to exceed 10 moles of N-octadecyltrimethylenediamine percent by weight of the cured coating,
160
VerDate 06
provided that the cured coating only con- a coating weight of 4 milligrams per square tacts food containing not more than 8 per- inch, and that are intended for contact cent alcohol. under conditions of use D, E, F or G de- Meta-Xylylenediamine (1,3-benzenedi- scribed in table 2 of paragraph (d) of this methanamine, CAS Reg. No. 1477–55–0), for section with alcoholic beverages con- use only in coatings at a level not to ex- taining less than 8 percent alcohol. ceed 3 percent by weight of the resin when such coatings are intended for repeated use (ix) Coumarone-indene resin, as the in contact with foods only of the types basic polymer. identified in paragraph (d) of this section, (x) Petroleum hydrocarbon resin table 1, under Types I, II, and III, under (cyclopentadiene type), as the basic conditions of use C, D, E or F as described polymer. in table 2 of paragraph (d) of this section; (xi) Terpene resins, as the basic poly- or when such coatings are intended for re- mer, from one or more of the following: peated use in contact with foods of the types identified in paragraph (d) of this Dipentene. section, table 1, under Types V, VI, VII, Hydrogenated dipentene resin (CAS Reg. No. and VIII, under conditions of use E or F as 106168–39–2). For use only with coatings in described in table 2 of paragraph (d) of this contact with acidic and aqueous foods. section. Use shall be limited to coatings Hydrogenated-beta-pinene-alpha-pinene- for tanks of capacity greater than 530,000 dipentene copolymer resin (CAS Reg. No. gallons. 106168–37–0). For use only with coatings in Para-Xylylenediamine (1,4 benzenedimethan- contact with acidic and aqueous foods. amine, CAS Reg. No. 539–48–0), for use only α-Pinene. in coatings at a level not to exceed 0.6 per- β-Pinene. cent by weight of the resin when such coat- ings are intended for repeated use in con- (xii) Urea-formaldehyde, resins and tact with foods only of the types identified their curing catalyst: in paragraph (d) of this section, table 1, (a) Urea-formaldehyde resins, as the under Types I, II, III, under conditions of basic polymer: use C, D, E, or F as described in table 2 of paragraph (d) of this section; or when such Urea-formaldehyde. coatings are intended for repeated use in Urea-formaldehyde chemically modified with contact with foods of the types identified methyl, ethyl, propyl, isopropyl, butyl, or in paragraph (d) of this section, table 1, isobutyl alcohol. under Types V, VI, VII, and VIII, under Urea-formaldehyde chemically modified with conditions of use E and F as described in one or more of the amine catalysts listed table 2 of paragraph (d) of this section. Use in paragraph (b)(3)(viii)(b) of this section. shall be limited to coatings for tanks of ca- (b) Curing (cross-linking) catalyst for pacity greater than 530,000 gallons. urea-formaldehyde resins: (c) Adjuncts for epoxy resins: Dodecyl benzenesulfonic acid (C.A. Registry Aluminum butylate. No. 27176–87–0). Benzoic acid, for use as a component in epoxy resins for coatings not exceeding a (xiii) Triazine-formaldehyde resins coating weight of 4 milligrams per square and their curing catalyst: inch and that are intended for contact (a) Triazine-formaldehyde resins, as under conditions of use D, E, F or G de- the basic polymer: scribed in table 2 of paragraph (d) of this section with alcoholic beverages con- Benzoguanamine-formaldehyde. taining less than 8 percent alcohol. Melamine-formaldehyde. Polyamides from dimerized vegetable oils Melamine-formaldehyde chemically modified and the amine catalysts listed in para- with one or more of the following amine graph (b)(3)(viii)(b) of this section, as the catalysts: basic polymer. Amine catalysts listed in paragraph Silane coupled silica, prepared from the re- (b)(3)(viii)(b) of this section. action of microcrystalline quartz with N- Dimethylamine-2-methyl-1-propanol. beta-(N-vinylbenzylamino) ethyl-gamma- Methylpropanolamine. aminopropyltrimethoxy silane, mono- Triethanolamine. hydrogen chloride, for use only in coatings Melamine-formaldehyde chemically modified intended for repeated use in contact with with methyl, ethyl, propyl, isopropyl, foods only of the types identified in para- butyl, or isobutyl alcohol. graph (d) of this section, table 1, under (b) Curing (cross-linking) catalyst for Category I and Category VIII, at tempera- triazine-formaldehyde resins: tures not exceeding 88 °C (190 °F). Succinic anhydride, for use as a component Dodecyl benzenesulfonic acid (C.A. Registry in epoxy resins for coatings not exceeding No. 27176–87–0).
161
VerDate 06
(xiv) Modifiers (for oils and alkyds, on polymer solids for use only in coatings including polyesters), as the basic poly- for containers intended for contact with mer: foods under conditions B, C, D, E, F, G, or H described in table 2 of paragraph (d) of Butyl methacrylate. this section. Cyclopentadiene. Methyl, ethyl, butyl, or octyl esters of acryl- (xvi) Cellulosics, as the basic poly- ic acid. mer: Methyl methacrylate. Carboxymethylcellulose. Styrene. Cellulose acetate. Vinyl toluene. Cellulose acetate-butyrate. (xv) Vinyl resinous substance, as the Cellulose acetate-propionate. basic polymers: Ethylcellulose. Ethyl hydroxyethylcellulose. Polyvinyl acetate. Hydroxyethylcellulose. Polyvinyl alcohol. Hydroxypropyl methylcellulose. Polyvinyl butyral. Methylcellulose. Polyvinyl chloride. Nitrocellulose. Polyvinyl formal. Polyvinylidene chloride. (xvii) Styrene polymers, as the basic Polyvinyl pyrrolidone. polymer: Polyvinyl stearate. Vinyl chloride-acetate-2,3-epoxypropyl meth- Polystyrene. acrylate copolymers containing not more α-Methyl styrene polymer. than 10 weight percent of total polymer Styrene copolymerized with one or more of units derived from 2,3-epoxypropyl meth- the following: acrylate and not more than 0.1 weight per- Acrylonitrile. cent of unreacted 2,3-epoxypropyl meth- α-Methylstyrene. acrylate monomer for use in coatings for containers. (xviii) Polyethylene and its copoly- Vinyl chloride-acetate, hydroxyl-modified mers as the basic polymer: copolymer. Vinyl chloride-acetate, hydroxyl-modified Ethylene-ethyl acrylate copolymer. copolymer, reacted with trimellitic anhy- Ethylene-isobutyl acrylate copolymers con- dride. taining no more than 35 weight percent of Vinyl chloride copolymerized with acryl- total polymer units derived from isobutyl amide and ethylene in such a manner that acrylate. the finished copolymers have a minimum Ethylene-vinyl acetate copolymer. weight average molecular weight of 30,000 Polyethylene. and contain not more than 3.5 weight per- (xix) Polypropylene as the basic poly- cent of total polymer units derived from mer: acrylamide; the acrylamide portion may or may not be subsequently partially Polypropylene. hydrolyzed. Maleic anhydride adduct of polypropylene Vinyl chloride copolymerized with one or The polypropylene used in the manufac- more of the following substances: ture of the adduct complies with Acrylonitrile. § 177.1520(c), item 1.1; and the adduct has a Fumaric acid and/or its methyl, ethyl, maximum combined maleic anhydride con- propyl, butyl, amyl, hexyl, heptyl, or octyl tent of 0.8 percent and a minimum intrin- esters. sic viscosity of 0.9, determined at 135 °C on Maleic acid and/or its methyl, ethyl, propyl, a 0.1 percent solution of the modified poly- butyl, amyl, hexyl, heptyl, or octyl esters. propylene in decahydronaphthalene as de- 5-Norbornene-2,3-dicarboxylic acid, mono-n- termined by a method titled ‘‘Method for butyl ester; for use such that the finished Determination of Intrinsic Viscosity of vinyl chloride copolymers contain not Maleic Anhydride Adduct of Poly- more than 4 weight percent of total poly- propylene,’’ which is incorporated by ref- mer units derived from this comonomer. erence. Copies are available from the Cen- Vinyl acetate. ter for Food Safety and Applied Nutrition Vinylidene chloride. (HFS–200), Food and Drug Administration, Vinyl chloride-vinylidene chloride-2,3- 200 C St. SW., Washington, DC 20204, or epoxypropyl methacrylate copolymers con- available for inspection at the Office of the taining not more than 10 weight percent of Federal Register, 800 North Capitol Street, total polymer units derived from 2,3- NW., suite 700, Washington, DC 20408. epoxypropyl methacrylate and not more than 0.05 weight percent of unreacted 2,3- (xx) Acrylics and their copolymers, epoxypropyl methacrylate monomer based as the basic polymer:
162
VerDate 06
Acrylamide with ethylacrylate and/or sty- containing no more than 2 weight percent rene and/or methacrylic acid, subsequently of total polymer units derived from meth- reacted with formaldehyde and butanol. acrylic acid and containing no more than Acrylic acid and the following esters thereof: 9.5 weight percent of total polymer units Ethyl. derived from hydroxyethyl methacrylate; Methyl. for use only in coatings in contact with dry Butyl acrylate-styrene-methacrylic acid-hy- food (food type VIII in table 1 of paragraph droxyethyl methacrylate copolymers con- (d) of this section). 2-(Dimethylamino) eth- taining no more than 20 weight percent of anol (C.A.S. Registry No. 108–01–0) may be total polymer units derived from meth- employed as an optional adjuvant sub- acrylic acid and containing no more than 7 stance limited to no more than 2 weight weight percent of total polymer units de- percent based on polymer solids in the rived from hydroxyethyl methacrylate; for coating emulsion. use only in coatings that are applied by Styrene polymers made by the polymeriza- electrodeposition to metal substrates. tion of any combination of styrene or Butyl acrylate-styrene-methacrylic acid- alpha methyl styrene with acrylic acid, hydroxypropyl methacrylate copolymers methacrylic acid, 2-ethyl hexyl acrylate, containing no more than 20 weight percent methyl methacrylate, and butyl acrylate. of total polymer units derived from meth- The styrene and alpha methyl styrene, in- acrylic acid and containing no more than 7 dividually, may constitute from 0 to 80 weight percent of total polymer units de- weight percent of the polymer. The other rived from hydroxypropyl methacrylate; monomers, individually, may be from 0 to for use only in coatings that are applied by 40 weight percent of the polymer. The poly- electrodeposition to metal substrates and mer number average molecular weight (Mn) that are intended for contact, under condi- shall be at least 2,000 (as determined by gel tion of use D, E, F, or G described in table permeation chromatography). The acid 2 of paragraph (d) of this section, with food number of the polymer shall be less than containing no more than 8 percent of alco- 250. The monomer content shall be less hol. than 0.5 percent. The polymers are for use Ethyl acrylate-styrene-methacrylic acid co- only in contact with food of Types IV–A, V, polymers for use only as modifiers for VII in table 1 of paragraph (d) of this sec- epoxy resins listed in paragraph tion, under use conditions E through G in (b)(3)(viii)(a) of this section. table 2 of paragraph (d), and with food of 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 section: thereof: (a) Metals: Butyl. 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.
163
VerDate 06
(b) Salts: Petrolatum. Polyethylene wax. Caprate. Polyoxyethylene glycol monooleate (mol. Caprylate. wt. of the polyoxyethylene glycol moiety Isodecanoate. greater than 300). Linoleate. Polytetrafluoroethylene. Naphthenate. Silicones (not less than 300 centistokes vis- Neodecanoate. cosity): Dimethylpolysiloxanes and/or Octoate (2-ethylhexoate). methylphenylpolysiloxanes. The methyl- Oleate. phenylpolysiloxanes contain not more than Palmitate. 2.0 percent by weight of cyclosiloxanes Resinate. having up to and including 4 siloxy units. Ricinoleate. Silicones (not less than 100 centistokes vis- Soyate. cosity): Dimethylpolysiloxanes and/or Stearate. methylphenylpolysiloxanes limited to use Tallate. only on metal substrates. The (xxiii) Waxes: methylphenylpolysiloxanes contain not more than 2.0 percent by weight of Paraffin, Type I. cyclosiloxanes having up to and including 4 Paraffin, Type II. siloxy units. Polyethylene. Sperm oil. (xxvi) Colorants used in accordance Spermaceti. with § 178.3297 of this chapter. (xxiv) Plasticizers: (xxvii) Surface lubricants: Acetyl tributyl citrate. Cottonseed oil and other edible oils. Acetyl triethyl citrate. Dibutyl sebacate. Butyl phthalyl butyl glycolate. Dioctyl sebacate. Butyl stearate. Glyceryl monostearate. p-tert-Butyl phenyl salicylate. Lanolin. Dibutyl sebacate. Mineral oil, white. Diethyl phthalate. Palm oil. Diisobutyl adipate. Paraffin, Type I. Diisooctyl phthalate. Paraffin, Type II. Epoxidized soybean oil (iodine number max- Petrolatum. imum 14; oxirane oxygen content 6% min- Stearic acid. imum), as the basic polymer. (xxviii) Silicones and their curing Ethyl phthalyl ethyl glycolate. catalysts: 2-Ethylhexyl diphenyl phosphate. di-2-Ethylhexyl phthalate. (a) Silicones as the basic polymer: 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 (xxv) Release agents, as the basic dimethylmethylhydrogen polysiloxane polymer, when applicable: (CAS Reg. No. 68037–59–2), where the plat- 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
164
VerDate 06
Tetramethyltetravinylcyclotetrasiloxane Dibenzamido phenyl disulfide. (CAS Reg. No. 2554–06–5). Di-β-naphthyl phenylenediamine. Dipentamethylene thiuram tetrasulfide. (b) Curing (cross-linking) catalysts Isobutylene-isoprene-divinylbenzene copoly- for silicones (the maximum amount of mers for use only at levels not to exceed 15 tin catalyst used shall be that required percent by weight of the dry cement com- to effect optimum cure but shall not position. exceed 1 part of tin per 100 parts of si- Naphthalene sulfonic acid-formaldehyde con- loxane resins solids): densate, sodium salt, for use only at levels not to exceed 0.6 percent by weight of the Dibutyltin dilaurate. cement solids in can end cements for con- Stannous oleate. tainers having a capacity of not less than Tetrabutyl titanate. 5 gallons. (xxix) Surface active agents: Sodium decylbenzene sulfonate. Sodium nitrite for use only at levels not to Ethylene oxide adduct of 2,4,7,9-tetramethyl- exceed 0.3 percent by weight of the cement 5-decyn-4,7-diol (CAS Reg. No. 9014–85–1). solids in can end cements for containers Poly[2-(diethylamino) ethyl methacrylate] having a capacity of not less than 5 gal- phosphate (minimum intrinsic viscosity in lons. water at 25 °C is not less than 9.0 deciliters Sodium pentachlorophenate for use as a pre- per gram as determined by ASTM method servative at 0.1 percent by weight in can- D1243–79, ‘‘Standard Test Method for Dilute sealing compounds on containers having a Solution Viscosity of Vinyl Chloride Poly- capacity of 5 gallons or more. mers,’’ which is incorporated by reference Sodium phenylphenate. (copies may be obtained from the Amer- Styrene-maleic anhydride resin, partial ican Society for Testing Materials, 1916 methyl and butyl (sec- or iso-) esters, for Race St., Philadelphia, PA 19103, or may be use only at levels not in excess of 3 percent examined at the Office of the Federal Reg- of the cement solids in can end cement for- ister, 800 North Capitol Street, NW., suite mulations. 700, Washington, DC 20408), for use only as Tetrasodium EDTA (tetrasodium ethylene- a suspending agent in the manufacture of diaminetetraacetate). vinyl chloride copolymers and limited to Tri (mixed mono- and dinonylphenyl) use at levels not to exceed 0.1 percent by phosphite. weight of the copolymers. Zinc dibutyldithiocarbamate. Sodium dioctyl sulfosuccinate. Sodium dodecylbenzenesulfonate (xxxii) Side seam cements: In addi- Sodium lauryl sulfate. tion to the substances listed in para- 2,4,7,9-Tetramethyl-5-decyn-4,7-diol (C.A.S. graph (b)(3) (i) to (xxx), inclusive, of Reg. No. 126-86-3), for use only in can coat- this section, the following may be used. ings which are subsequently dried and cured at temperatures of at least 193 °C (380 p-tert-Butyl perbenzoate as a catalyst for °F) for 4 minutes. epoxy resin. epsilon-Caprolactam-(ethylene-ethyl acry- (xxx) Antioxidants: 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 of the types identified in paragraph (d) of (xxxi) Can end cements (sealing com- this section, table 1, under Categories I, II, pounds used for sealing can ends only): and VI. In addition to the substances listed in 4,4′-Bis(alpha,alpha-dimethyl- paragraph (b) of this section and those benzyl)diphenylamine, CAS Reg. No. 10081– listed in § 177.1210(b)(5) of this chapter, 67–1. the following may be used: Ethyl toluene sulfonamide. N,N′-Hexamethylenebis(3,5-di-tert-butyl-4- Butadiene-styrene-divinylbenzene copolymer hydroxyhydrocinnamide), CAS Reg. No. (CAS Reg. No. 26471–45–4) for use only at 23128–74–7. levels not to exceed 23.8 percent by weight Polyamides consisting of the following: of the cement solids in can end cements. Copolymer of omega-laurolactam and Butadiene-styrene-fumaric acid copolymer. espilon-caprolactam, CAS Reg. No. 25191– 4,4′-Butylidenebis (6-tert-butyl-m-cresol). 04–2 (Nylon 12/6).
165
VerDate 06
Homopolymer of omega-aminododecanoic and sebacic acid (CAS Reg. No. 68604–06–8). acid, CAS Reg. No. 24937–16–4. The condensation product formed by the Homopolymer of omega-laurolactam, CAS reaction of hydrogenated castor oil with Reg. No. 25038–74–8 (Nylon 12). polyamide derived from ethylenediamine, Polyamides derived from the following acids sebacic acid and 12-hydroxystearic acid, for and amines: use only in coatings at a level not to ex- Acids: ceed 3.2 percent by weight of the resin Adipic. when such coatings are intended for re- Azelaic. peated use in contact with foods only of Sebacic. the types identified in paragraph (d) of this Vegetable oil acids (with or without section, table 1, under Types I, II, and III, dimerization). under conditions of use C, D, E, or F as de- Amines: scribed in table 2 of paragraph (d) of this Diethylenetriamine. section; or when such coatings are in- Diphenylamine. tended for repeated use in contact with Ethylenediamine. foods of the types identified in paragraph Hexamethylenediamine. (d) of this section, table 1, under Types V, Tetraethylenepentamine. VI, VII, and VIII, under conditions of use E Triethylenetetramine. or F as described in table 2 of paragraph (d) Polypropylene glycol CAS Reg. No. 25322–69– of this section. Use shall be limited to 4. coatings for tanks of capacity greater than Sodium pentachlorophenate for use as a pre- 530,000 gallons. servative at 0.1 percent by weight in can- Castor oil, sulfated, sodium salt (CAS Reg. sealing compounds on containers having a No. 68187–76–8), for use only in coatings for capacity of 5 gallons or more. containers intended for repeated use. Tetrakis [methylene(3,5-di-tert-butyl-4- Cetyl alcohol. hydroxyhydrocinnamate)]methane, CAS Cyclohexanone-formaldehyde resin produced Reg. No. 6683–19–8. when 1 mole of cyclohexanone is made to Toluene sulfonamide formaldehyde resin react with 1.65 moles of formaldehyde such (basic polymer). that the finished resin has an average mo- Triethylene glycol methacrylate for use only lecular weight of 600–610 as determined by as polymerization cross-linking agent in ASTM method D2503–82, ‘‘Standard Test side seam cements for containers intended Method for Molecular Weight (Relative for use in contact with food only of the Molecular Mass) of Hydrocarbons by Ther- types identified in paragraph (d) of this moelectric Measurement of Vapor Pres- section, table 1, under Categories I, II, and sure,’’ which is incorporated by reference. VI. Copies may be obtained from the American Urea. Society for Testing Materials, 1916 Race (xxxiii) Miscellaneous materials: St., Philadelphia, PA 19103, or may be ex- amined at the Office of the Federal Reg- Ammonium citrate. ister, 800 North Capitol Street, NW., suite Ammonium potassium phosphate. 700, Washington, DC 20408. For use only in Bentonite, modified by reaction with benzyl contact with nonalcoholic and nonfatty dimethyl alkyl ammonium chloride, where foods under conditions of use E, F, and G, the alkyl groups are derived from hydro- described in table 2 of paragraph (d) this genated tallow (CAS Reg. No. 71011–24–0). section. For use only as a rheological agent in coat- Decyl alcohol. ings intended to contact food under re- Disodium hydrogen phosphate. peated use conditions. Ethyl acetoacetate. Bentonite, modified by reaction with sodium Hectorite, modified by reaction with a mix- stearate and benzyl dimethyl alkyl ammo- ture of benzyl methyl dialkyl ammonium nium chloride, where the alkyl groups are chloride and dimethyl dialkyl ammonium derived from hydrogenated tallow (CAS chloride, where the alkyl groups are de- Reg. No. 121888–68–4). For use as a rived from hydrogenated tallow (CAS Reg. rheological agent only in coatings in- No. 121888–67–3). For use as a rheological tended to contact dry food under repeated- agent only in coatings intended to contact use conditions. dry food under repeated-use conditions. Calcium acetate. Lauryl alcohol. Calcium ethyl acetoacetate. Lecithin. Calcium glycerophosphate. Magnesium, sodium, and potassium citrate. Calcium, sodium, and potassium oleates. Magnesium glycerophosphate. Calcium, sodium, and potassium Magnesium stearate. ricinoleates. Mono-, di-, and tricalcium phosphate. Calcium, sodium, and potassium stearates. Monodibutylamine pyrophosphate as Castor oil, hydrogenated. sequestrant for iron. Castor oil, hydrogenated polymer with ethyl- Mono-, di-, and trimagnesium phosphate. enediamine, 12-hydroxyoctadecanoic acid Myristyl alcohol.
166
VerDate 06
Octyl alcohol. imum amine value of 8.5 derived from Phosphoric acid. dimerized vegetable oil acids (con- Polybutene, hydrogenated; complying with taining not more than 10 percent of the identity and limitations prescribed by § 178.3740 of this chapter. monomer acids), ethylenediamine, and Poly(ethylene oxide). 4,4-bis (4-hydroxyphenyl) pentanoic Siloxanes and silicones, dimethyl, 3- acid (in an amount not to exceed 10 hydroxypropyl group-terminated, diesters percent by weight of said polyamide with poly(2-oxepanone), diacetates (CAS resins); as the basic resin, for use only 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- ester, epoxy, and acrylic coatings com- the polyamide resins in the finished 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
167
VerDate 06
area of the food-contact surface of the square inch that would equal 0.005 per- container in square inches. From a fab- cent of the water capacity of the con- ricated container conforming with the tainer in milligrams, divided by the description in this paragraph (c)(1), the area of the food-contact surface of the extractives shall not exceed 0.5 milli- container in square inches. gram per square inch of food-contact (4) From coating intended for re- surface nor exceed 50 parts per million peated use, and employed other than as of the water capacity of the container a component of a container, not to ex- as determined by the methods provided ceed 18 milligrams per square inch of in paragraph (e) of this section. coated surface. (2) From a coating intended for or (d) Tables: employed as a component of a con- tainer having a capacity in excess of 1 TABLE 1ÐTYPES OF FOOD gallon and intended for one-time use, I. Nonacid (pH above 5.0), aqueous products; may contain not to exceed 1.8 milligrams per square salt or sugar or both, and including oil-in-water emulsions of low- or high-fat content. inch nor to exceed that amount as mil- II. Acidic (pH 5.0 or below), aqueous products; may contain ligrams per square inch that would salt or sugar or both, and including oil-in-water emulsions equal 0.005 percent of the water capac- of low- or high-fat content. III. Aqueous, acid or nonacid products containing free oil or ity of the container in milligrams, di- fat; may contain salt, and including water-in-oil emulsions vided by the area of the food-contact of low- or high-fat content. surface of the container in square IV. Dairy products and modifications: inches. A. Water-in-oil emulsion, high- or low-fat. B. Oil-in-water emulsion, high- or low-fat. (3) From a coating intended for or V. Low moisture fats and oils. employed as a component of a con- VI. Beverages: tainer for repeated use, not to exceed A. Containing alcohol. B. Nonalcoholic. 18 milligrams per square inch nor to VII. Bakery products. exceed that amount as milligrams per VIII. Dry solids (no end test required).
TABLE 2ÐTEST 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 1 2 8 percent alcohol table 1) Water (time and Heptane (time (time and tempera- temperature) and temperature) ture)
A. High temperature heat-sterilized I, IV±B ...... 250 °F, 2 hr ...... (e.g., over 212 °F). III, IV±A, VII ...... do ...... 150 °F, 2 hr. B. Boiling water sterilized ...... II ...... 212 °F, 30 min ...... III, VII ...... do ...... 120 °F, 30 min. C. Hot filled or pasteurized above 150 II, IV±B ...... Fill boiling, cool to ...... °F. 100 °F. III, IV±A ...... do ...... 120 °F, 15 min ...... V ...... do ...... D. Hot filled or pasteurized below 150 II, IV±B, VI±B ...... 150 °F, 2 hr ...... °F. III, IV±A ...... do ...... 100 °F, 30 min. V ...... do ...... VI±A ...... 150 °F, 2 hr E. Room temperature filled and stored I, II, IV±B, VI±B ..... 120 °F, 24 hr ...... (no thermal treatment in the con- III, IV±A ...... do ...... 70 °F, 30 min. tainer). V, VII ...... do ...... VI±A ...... 120 °F, 24 hr F. Refrigerated storage, no thermal I, II, III, IV±A, IV±B, 70 °F, 48 hr ...... treatment in the container). VI±B, VII. 70 °F, 48 hr VI±A ...... G. Frozen storage (no thermal treat- I, II, III, IV±B, VII ... 70 °F, 24 hr ...... ment in the container). H. Frozen storage: Ready-prepared foods intended to be reheated in con- tainer at time of use:. 1. Aqueous or oil in water emulsion I, II, IV±B ...... 212 °F, 30 min. of high or low fat. 2. Aqueous, high or low free oil or III, IV±A, VII ...... do ...... 120 °F, 30 min. fat. 1 Heptane extractant not to be used on wax-lined containers. 2 Heptane extractivity results must be divided by a factor of five in arriving at the extractivity for a food product.
168
VerDate 06
(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.
169
VerDate 06
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
170
VerDate 06
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
171
VerDate 06
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- (c )( s ) 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. (s )( F ) ° (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 (c )( s )( F ) 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.
172
VerDate 06
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.
173
VerDate 06
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 in the Finding Aids sec- (3) Substances identified in this para- tion of this volume. graph (b)(3) and subject to such limita- 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.
174
VerDate 06
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. 68139±70±8), as the For use only in coatings for polypropylene films that contact basic resin, derived from: food at temperatures not to exceed room temperature. Dimerized vegetable oil or tall oil acids containing not more than 20 percent of monomer acids. Azelaic acid (CAS Reg. No. 123±99±9) in an amount not to exceed 3.7 percent by weight of the poly- amide resin. Ethylenediamine (CAS Reg. No. 107±15±3). Piperazine (CAS Reg. No. 110±85±0) in an amount not to exceed 6.4 percent by weight of the 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 ......
175
VerDate 06
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. 68083± 18±1 and CAS Reg. No. 68083±19±2) with methylhydrogen polysiloxane (CAS Reg. No. 63148±57±2) and dimethylmethylhydrogen polysiloxane (CAS Reg. No. 68037± 59±2). The following substances may be used as optional polymerization inhibitors:. 3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. 107±54±0), at a level not to exceed 0.53 weight percent;. 1-Ethynylcyclohexene (CAS Reg. No. 931±49±7), at a level not to exceed 0.64 weight percent;. Bis(methoxymethyl)ethyl maleate (CAS Reg. No. 102054±10±4), at a level not to exceed 1.0 weight percent;. Methylvinyl cyclosiloxane (CAS Reg. No. 68082±23±5); and. Tetramethyltetravinylcyclotetrasiloxane (CAS Reg. No. 2554±06±5).. Siloxanes and silicones; platinum-catalyzed reaction product of Platinum content not to exceed 100 parts per million. For use vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a surface coating under the following conditions: 68083±19±2 and 68083±18±1), with methyl hydrogen 1. In coatings for olefin polymers provided the coating contacts polysiloxane (CAS Reg. No. 63148±57±2). Dimethyl maleate food only of the types identified in § 176.170(c) of this chap- (CAS Reg. No. 624±48±6) and vinyl acetate (CAS Reg. No. ter, table 1, under Types I, II, VI, and VII±B when used 108±05±4) may be used as optional polymerization inhibi- under conditions of use E, F, and G described in table 2 in tors.. § 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, VII±A, VIII, and IX when used under conditions of use A through H described in table 2 in § 176.170(c) of this chapter. Siloxanes and silicones; platinum-catalyzed reaction product of Platinum content not to exceed 100 parts per million. For use vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a release coating for pressure sensitive adhesives. 68083±19±2 and 68083±18±1), with methyl hydrogen polysiloxane (CAS Reg. No. 63148±57±2). Dimethyl maleate (CAS Reg. No. 624±48±6), vinyl acetate (CAS Reg. No. 108±05±4), dibutyl maleate (CAS Reg. No. 105±76±0) and diallyl maleate (CAS Reg. No. 999±21±3) may be used as optional polymerization inhibitors. The polymer may also contain C16±C18 olefins (CAS Reg. No. 68855±60±7) as a control release agent.. Styrene copolymerized with one or more of the following: Acrylonitrile. α-Methyl styrene. Styrene polymers made by the polymerization of any com- For use only in contact with foods of Types IV±A, V, and VII in bination of styrene or alpha methyl styrene with acrylic table 1 of § 176.170(c) of this chapter, under use conditions acid, methacrylic acid, 2-ethyl hexyl acrylate, methyl E through G in table 2 of § 176.170(c), and with foods of methacrylate, and butyl acrylate. The styrene and alpha Types VIII and IX without use temperature restriction. methyl styrene, individually, may constitute from 0 to 80 weight percent of the polymer. The other monomers, 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. 1804±87±1]. F, and G described in table 2 of § 176.170(c) of this chapter and limited to use at a level not to exceed 2.0 percent by weight of the dry copolymer coating. Vinyl chloride-acetate, hydroxyl-modified copolymer or ma- leic acid-modified copolymer. Vinyl chloride copolymerized with one or more of the fol- lowing: Acrvlonitrile. Vinyl acetate. Vinylidene chloride.
176
VerDate 06
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. 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. 110±31±6) .. 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- 87±100. vided the finished polyolefin films contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types V, VIII, and IX. Sodium dioctyl sulfosuccinate. Sodium dodecylbenzenesulfonate. Sodium lauryl sulfate. Sorbitan and sorbitol esters of fatty acids from vegetable or animal oils. Spermaceti wax. Tetrahydrofuran. Toluene. (iv) Preservatives: Silver chloride-coated titanium dioxide...... For use only as a preservative in latex emulsions at a level not to exceed 2.2 parts per million (based on silver ion con- centration) in the dry coating.
(c) The coating in the finished form shall yield net chloroform-soluble ex- in which it is to contact food, when ex- tractives not to exceed 0.5 milligram tracted with the solvent or solvents per square inch of coated surface. characterizing the type of food, and (d) Acrylonitrile copolymers identi- under conditions of time and tempera- fied in this section shall comply with ture characterizing the conditions of its intended use as determined from ta- bles 1 and 2 of § 176.17(c) of this chapter,
177
VerDate 06
the provisions of § 180.22 of this chap- not exceed 0.5 milligram per square ter. inch of coated surface. (ii) The chloroform-soluble portion of [42 FR 14534, Mar. 15, 1977, as amended at 43 FR 7206, Feb. 21, 1978; 45 FR 6541, Jan. 29, the n-heptane extractives of the coated 1980; 47 FR 22512, May 25, 1982; 49 FR 36497, film obtained with n-heptane at 70 °F Sept. 18, 1984; 50 FR 47209, Nov. 15, 1985; 56 FR for 30 minutes does not exceed 0.5 milli- 49674, Oct. 1, 1991; 61 FR 14246, Apr. 1, 1996; 63 gram per square inch of coated surface. FR 71017, Dec. 23, 1998; 64 FR 2568, Jan. 15, (2) Conditions of use. The copolymer 1999] of vinyl acetate and crotonic acid is used as a coating or as a component of § 175.350 Vinyl acetate/crotonic acid copolymer. a coating for polyolefin films for pack- aging bakery products and confec- A copolymer of vinyl acetate and tionery. crotonic acid may be safely used as a coating or as a component of a coating § 175.360 Vinylidene chloride copoly- which is the food-contact surface of mer coatings for nylon film. polyolefin films intended for packaging Vinylidene chloride copolymer coat- food, subject to the provisions of this ings identified in this section and ap- section. plied on nylon film may be safely used (a) The copolymer may contain added as food-contact surfaces, in accordance optional substances to impart desired with the following prescribed condi- properties. 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 any limitations further provided. complying with § 177.1500 of this chap- (c) Any optional substance that is ter. the subject of a regulation in parts 174, (b) The coatings are prepared from 175, 176, 177, 178, and § 179.45 of this vinylidene chloride copolymers pro- chapter conforms with any specifica- duced by copolymerizing vinylidene tions in such regulation. chloride with one or more of the mono- (d) Optional substances as provided mers acrylic acid, acrylonitrile, ethyl in paragraph (a) of this section include: acrylate, methacrylic acid, methyl ac- (1) Substances generally recognized rylate, methyl methacrylate (CAS Reg. as safe in food. No. 80–62–6; maximum use level 6 (2) Substances subject to prior sanc- weight percent) and 2-sulfoethyl meth- tion or approval for uses with a copoly- acrylate (CAS Reg. No. 10595–80–9; max- mer of vinyl acetate and crotonic acid imum use level 1 weight percent). The and used in accordance with such sanc- finished copolymers contain at least 50 tion or approval. weight percent of polymer units de- (3) Substances identified in this sub- rived from vinylidene chloride. The fin- paragraph and subject to such limita- ished coating produced from vinylidene tions as are provided: chloride copolymers produced by co- polymerizing vinylidene chloride with List of substances Limitations methyl methacrylate and/or 2- sulfoethyl methacrylate, or with meth- Silica. Japan wax. yl methacrylate and/or 2-sulfoethyl methacrylate together with one or (e) Copolymer of vinyl acetate and more of the other monomers from this crotonic acid used as a coating or as a section, is restricted to use at or below component of a coating conforming room temperature. with the specifications of paragraph (c) Optional adjuvant substances em- (e)(1) of this section are used as pro- ployed in the production of the coat- vided in paragraph (e)(2) of this sec- ings or added thereto to impart desired tion. properties may include sodium (1) Specifications. (i) The chloroform- dodecylbenzenesulfonate. soluble portion of the water extractives (d) The coating in the finished form of the coated film obtained with dis- in which it is to contact food, when ex- tilled water at 120 °F for 24 hours does tracted with the solvent or solvents
178
VerDate 06
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) [42 FR 14534, Mar. 15, 1977, as amended at 43 of this section may be safely used as a 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 film. (a) The resins are produced by the 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- rylate, and acrylic acid. The finished (b) The resins identified in paragraph copolymers contain at least 50 weight- (a) of this section may be used as a percent of polymer units derived from food-contact coating for articles in- vinyldene chloride. tended for contact at temperatures not ° (c) Optional adjuvant substances em- to exceed 160 F with food of Types I, ployed in the production of the coat- II, VI–A and B, and VIII described in ings or added thereto to impart desired table 1 of § 176.170(c) of this chapter properties may include sodium provided that the coating in the fin- dodecylbenzenesulfonate in addition to ished form in which it is to contact substances described in § 174.5(d) of this food meets the following extractives chapter. limitations when tested by the meth- (d) The coating in the finished form ods provided in § 175.300(e): in which it is to contact food, when ex- (1) The coating when extracted with tracted with the solvent or solvents distilled water at 180 °F for 24 hours characterizing the type of food, and yields total extractives not to exceed under the conditions of time and tem- 0.05 milligram per square inch of food- perature characterizing the conditions contact surface. of its intended use as determined from (2) The coating when extracted with 8 tables 1 and 2 of § 176.170(c) of this chap- percent (by volume) ethyl alcohol in ter, shall yield net chloroform-soluble distilled water at 160 °F for 4 hours extractives in each extracting solvent yields total extractives not to exceed not to exceed 0.5 milligram per square 0.05 milligram per square inch of food- inch of coated surface as determined by contact surface.
179
VerDate 06
(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 0.05 milligram per square inch of food- (e) The coatings are used as food-con- contact surface. tact surfaces for bulk reusable con- (2) The coating when extracted with tainers intended for storing, handling, 50 percent (by volume) ethyl alcohol in and transporting food. distilled water at 180 °F for 24 hours yields total extractives not to exceed PART 176—INDIRECT FOOD ADDI- 0.05 milligram per square inch. TIVES: PAPER AND PAPERBOARD § 175.390 Zinc-silicon dioxide matrix COMPONENTS 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, processing, preparing, treating, pack- Sec. aging, transporting, or holding food, 176.110 Acrylamide-acrylic acid resins. subject to the provisions of this sec- 176.120 Alkyl ketene dimers. tion; 176.130 Anti-offset substances. (a) The coating is applied to a metal 176.150 Chelating agents used in the manu- surface, cured, and washed with water facture of paper and paperboard. to remove soluble substances. 176.160 Chromium (Cr III) complex of N- (b) The coatings are formulated from ethyl-N-heptadecylfluoro-octane sulfonyl optional substances which include: glycine. (1) Substances generally recognized 176.170 Components of paper and paperboard as safe. in contact with aqueous and fatty foods. (2) Substances for which safe condi- 176.180 Components of paper and paperboard tions of use have been prescribed in in contact with dry food. § 175.300. 176.200 Defoaming agents used in coatings. (3) Substances identified in para- 176.210 Defoaming agents used in the manu- facture of paper and paperboard. graph (c) of this section, subject to the 176.230 3,5-Dimethyl-1,3,5,2H- limitations prescribed. tetrahydrothiadiazine-2-thione. (c) The optional substances per- 176.250 Poly-1,4,7,10,13-pentaaza-15- mitted are as follows: hydroxyhexadecane. List of substances Limitations 176.260 Pulp from reclaimed fiber. 176.300 Slimicides. Ethylene glycol ...... As a solvent removed by 176.320 Sodium nitrate-urea complex. water washing. 176.350 Tamarind seed kernel powder. Iron oxide. Lithium hydroxide ...... Removed by water washing. AUTHORITY: 21 U.S.C. 321, 342, 346, 348, 379e. Methyl orange ...... As an acid-base indicator. Potassium dichromate ...... Removed by water washing. SOURCE: 42 FR 14554, Mar. 15, 1977, unless Silica gel. otherwise noted. Sodium silicate. Zinc, as particulate metal. EDITORIAL NOTE: Nomenclature changes to part 176 appear at 61 FR 14482, Apr. 2, 1996. (d) The coating in the finished form in which it is to contact food, when ex-
180
VerDate 06
Subpart A [Reserved] used to prevent the transfer of inks employed in printing and decorating Subpart B—Substances for Use paper and paperboard used for food 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- ins. paper or paperboard in an amount not 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. effect and not to exceed 2 percent by Industrial starchÐmodified .... Complying with § 178.3520 of 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. tions that the alkyl ketene dimers and Pentasodium salt of diethylenetriamine pentaacetate. their hydrolysis products dialkyl Sodium fructoheptonate. ketones do not exceed 0.4 percent by Sodium glucoheptonate. weight of the paper or paperboard. Tetrasodium ethylenediamine tetra- (c) The alkyl ketene dimers may be acetate. Trisodium N-hydroxyethyl ethylene- used in the form of an aqueous emul- diamine triacetate. sion which may contain sodium lignosulfonate as a dispersant. (b) Any one or any combination of the substances named is used or in- § 176.130 Anti-offset substances. tended for use as chelating agents. Substances named in paragraphs (b) (c) The substances are added in an and (c) of this section may be safely amount not greater than that required
181
VerDate 06
to accomplish the intended technical paring, treating, packing, transporting, effect nor greater than any specific or holding aqueous and fatty foods, limitation, where such is provided. subject to the provisions of this sec- tion. Components of paper and paper- § 176.160 Chromium (Cr III) complex board in contact with dry food of the of N-ethyl-N-heptadecylfluoro-oc- type identified under Type VIII of table tane sulfonyl glycine. 1 in paragraph (c) of this section are The chromium (Cr III) complex of N- subject to the provisions of § 176.180. ethyl - N -heptadecylfluoro-octane (a) Substances identified in para- sulfonyl glycine containing up to 20 graph (a) (1) through (5) of this section percent by weight of the chromium (Cr may be used as components of the food- III) complex of heptadecylfluoro-octane contact surface of paper and paper- sulfonic acid may be safely used as a board. Paper and paperboard products component of paper for packaging dry shall be exempted from compliance food when used in accordance with the with the extractives limitations pre- following prescribed conditions. scribed in paragraph (c) of this section: (a) The food additive is used as a Provided, That the components of the component of paper in an amount not food-contact surface consist entirely of to exceed 0.5 percent by weight of the one or more of the substances identi- paper. fied in this paragraph: And provided fur- (b)(1) The food-contact surface of the ther, That if the paper or paperboard paper is overcoated with a polymeric or when extracted under the conditions resinous coating at least 1⁄3-mil in prescribed in paragraph (c) of this sec- thickness, that meets the provision of tion exceeds the limitations on extrac- § 176.170; or tives contained in paragraph (c) of this (2) The treated paper forms one or section, information shall be available more plies of a paper in a multiwall from manufacturing records from bag and is separated from the food by which it is possible to determine that at least one ply of packaging films or only substances identified in this para- grease-resistant papers which serves as graph (a) are present in the food-con- a functional barrier between the food tact surface of such paper or paper- additive and the food. Such packaging board. films or grease-resistant papers con- (1) Substances generally recognized form with appropriate food additive as safe in food. regulations. (2) Substances generally recognized (c) The labeling of the food additive as safe for their intended use in paper shall contain adequate directions for and paperboard products used in food its use to insure compliance with the packaging. requirements of paragraphs (a) and (b) (3) Substances used in accordance of this section. with a prior sanction or approval. (4) Substances that by regulation in § 176.170 Components of paper and pa- parts 170 through 189 of this chapter perboard in contact with aqueous may be safely used without extractives and fatty foods. limitations as components of the Substances identified in this section uncoated or coated food-contact sur- may be safely used as components of face of paper and paperboard in contact the uncoated or coated food-contact with aqueous or fatty food, subject to surface of paper and paperboard in- the provisions of such regulation. tended for use in producing, manufac- (5) Substances identified in this para- turing, packaging, processing, pre- graph, as follows:
List of Substances Limitations
Acetyl peroxide ...... For use only as polymerization catalyst. Acrylamide-methacrylic acid-maleic anhydride copolymers con- For use only as a retention aid employed prior to the sheet- taining not more than 0.2 percent of residual acrylamide forming operation in the manufacture of paper and paper- monomer and having an average nitrogen content of 14.9 board in such an amount that the finished paper and paper- percent such that a 1 percent by weight aqueous solution board will contain the additive at a level not in excess of has a minimum viscosity of 600 centipoises at 75 °F, as de- 0.05 percent by weight of dry fibers in the finished paper and termined by LVG-series Brookfield viscometer (or equivalent) paperboard. using a No. 2 spindle at 30 r.p.m.
182
VerDate 06
List of Substances Limitations
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. 86830±15±1). Acrylic acid copolymer with 2-acrylamido-2-methylpropane-sul- For use only as a scale inhibitor prior to the sheet-forming op- fonic acid (CAS Reg. No. 40623±75±4) and/or its ammo- eration in the manufacture of paper and paperboard and nium/alkali metal mixed salts. The copolymer is produced by used at a level not to exceed 1.0 kilogram (2.2 pounds) of poly-merization of acrylic acid and 2-acrylamido-2- copolymer per 907 kilograms (1 ton) of dry paper and paper- methylpropane-sulfonic acid in a weight ratio of 60/40, such board fibers. that a 28 percent by weight aqueous solution of the polymer has a viscosity of 75±150 centipoises at 25 °C as 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 22.5±25.0 percent (Kjel- to exceed 0.5 percent by weight of the dry paper and paper- dahl dry basis) and containing no more than 0.075 percent board. monomer as ethylenediamine. The finished resin in a 24 per- cent by weight aqueous solution has a viscosity of 1,000± 2,000 centipoises at 25 °C as determined by LVT-series Brookfield viscometer using a No. 4 spindle at 50 r.p.m. (or by other equivalent method). Acrylonitrile polymer with styrene, reaction product with ethyl- 1. For use only as a sizing material applied after the sheet- enediamine acetate, having a nitrogen content of 7.4±8.3 forming operation in the manufacture of paper and paper- percent (Kjeldahl dry basis) and containing no more than board in such amount that the paper and paperboard will 0.25 percent monomer as ethylenediamine. contain the additive at a level not in excess of 0.25 percent by weight of the dry paper and paperboard. 2. For use only as a sizing material applied prior to the sheet- forming operation in the manufacture of paper and 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, IV±B, and VII±B described in table 1 of paragraph (c) of this section under conditions of use E, F, and G described in table 2 of paragraph (c) of this section. 2. In coatings for paper and paperboard with food of Type VIII described in table I of paragraph (c) of this section under conditions of use A through H described in table 2 of 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 C15±C21 groups. board and limited to use at a level not to exceed 1 percent by weight of the finished dry paper and paperboard fibers. Alkyl(C12±C20)methacrylatemethacrylic acid copolymers (CAS For use only as stabilizers employed prior to the sheet±forming Reg. No. 27401±06±5). operation in the manufacture of paper and paperboard. tert-Alkyl(C8±C16)mercaptans ...... For use only as polymerization-control agent. Aluminum acetate. 2-Amino-2-methyl-1-propanol (CAS Reg. No. 124±68±5) ...... For use as a dispersant for pigment suspension at a level not to exceed 0.25 percent by weight of pigment. The 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.
183
VerDate 06
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. 32535±84±5) For use only as an insolubilizer for binders used in coatings for and its tartaric acid adduct. paper and paperboard, and limited to use at a level not to exceed 2.5 percent by weight of coating solids. Ammonium zirconium citrate (CAS Reg. No. 149564±62±5), For use as insolubilizers with protein binders in coatings for ammonium zirconium lactate-citrate (CAS Reg. No. 149564± paper and paperboard, at a level not to exceed 1.4 percent 64±7), ammonium zirconium lactate (CAS Reg. No. 149564± by weight of coating solids. 63±6). Anionic polyurethane, produced by reacting the preliminary For use only as a surface sizing agent at a level not to exceed adduct formed from the reaction of glyceryl monostearate 0.1 percent by weight of dry paper and paperboard. and 2,4-toluenediisocyanate with not more than 10 mole 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). 9,10±Anthraquinone (Chemical Abstracts Service Registry No. For use only as a pulping aid in the alkaline pulping of 84±65±1) which has a purity of not less than 98 percent. lignocellulosic material at levels not to exceed 0.1 percent by weight of the raw lignocellulosic material. Aromatic petroleum hydrocarbon resin, hydrogenated (CAS For use only as modifiers in wax polymer blend coatings for Reg. No. 88526±47±0), produced by the catalytic polym- paper and paperboard at a level not to exceed 50 weight- erization of aromatic substituted olefins from low boiling dis- percent of the coating solids under conditions of use E, F, tillates of cracked petroleum stocks with a boiling point no and G identified in table 2 of paragraph (c) of this section. greater than 220 °C (428 °F), and the subsequent catalytic reduction of the resulting aromatic petroleum hydrocarbon resin. The resin meets the following specifications: softening point 85 °C (185 °F) minimum, as determined by ASTM Method E 28±67 (Reapproved 1982), ``Standard Test Meth- od for Softening Point by Ring-and-Ball Apparatus,'' and ani- line point 70 °C (158 °F) minimum, as determined by ASTM Method D 611±82, ``Standard Test Methods for Aniline Point and Mixed Aniline Point of Petroleum Products and Hydro- carbon Solvents,'' which are incorporated by reference in 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. 2634±33±5) ...... For use only as a preservative in paper coating compositions and limited to use at a level not to exceed 0.01 mg/in2 (0.0016 mg/cm2 ) of the finished paper and paperboard. Benzoyl peroxide ...... Do. N,N-Bis(2-hydroxyethyl)alkyl (C12±C18)amide ...... For use only as an adjuvant to control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet forming operation.
184
VerDate 06
List of Substances Limitations
Bis(methoxymethyl)tetrakis-[(octadecyloxy)-methyl]melamine For use only under the following conditions: resins having a 5.8±6.5 percent nitrogen content (CAS Reg. 1. As a water repellant employed prior to the sheet-forming op- No. 68412±27±1). eration in the manufacture of paper and paperboard in such amount that the finished paper and paperboard will contain the additive at a level not in excess of 1.6 percent by weight of the finished dry paper and paperboard fibers. 2. The finished paper and paperboard will be used in contact with nonalcoholic foods only. 3. As a water repellant employed after the sheet-forming 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, IV±B, VI, VII±B, and VIII described in table 1 of paragraph (c) of this section. 2-Bromo-2-nitro-1,3-propanediol (CAS Reg. No. 52±51±7) ...... For use only as an antimicrobial/preservative in fillers, pigment slurries, starch sizing solutions, and latex coatings at levels not to exceed 0.01 percent by weight of those components. 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(C16±C18)carbamoyl chloride (CAS Reg. No. 41319±54± For use as a sizing agent at a level not to exceed 0.2 percent 4) manufactured by the reaction of secondary amines de- by weight of the dry fiber. rived from fatty acids of animal or vegetable sources with phosgene. Diallyldimethyl ammonium chloride polymer with acrylamide For use only as a retention and/or drainage aid employed prior and potassium acrylate, produced by copolymerizing either to the sheet-forming operations in the manufacture of paper (1) diallyldimethyl ammonium chloride and acrylamide in a and paperboard and limited to use at a level not to exceed weight ratio of 50/50, with 4.4 percent of the acrylamide sub- 0.05 percent by weight of the finished paper and paper- sequently hydrolyzed to potassium acrylate or (2) polym- board. erized diallyldimethyl ammonium chloride, acrylamide and potassium acrylate (as acrylic acid) in a weight ratio of 50/ 47.8/2.2, respectively, so that the finished resin in a 1 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. 25136±75±8). Diallyldimethylammonium chloride with acrylamide (CAS Reg. For use only as a drainage and/or retention aid employed prior No. 26590±05±6). The copolymer is produced by copolym- to the sheet-forming operation in the manufacture of paper erizing diallyldimethylammonium chloride with acrylamide in and paperboard and limited to use at a level not to exceed a weight ratio of 50±50 so that the finished resin in a 1 per- 0.05 percent by weight of the finished paper and paper- cent by weight aqueous solution (active polymer) has a vis- board. cosity of more than 22 centipoises at 22 °C (71.6 °F), as de- termined by LVF-series Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or by other equivalent method).
185
VerDate 06
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: 50±2.5±47.5. The finished resin in a 1 per- For use only as a retention aid employed prior to the sheet- cent by weight aqueous solution has a minimum vis- forming operation in the manufacture of paper and paper- cosity of 22 centipoises. board and limited to use at a level not to exceed 0.05 per- cent by weight of the finished paper and paperboard. 2. Weight ratio: 25±2.5±72.5. The finished resin in a 0.20 For use only as a drainage and/or retention aid employed prior percent by weight aqueous solution has a minimum vis- to the sheet-forming operation in the manufacture of paper cosity of 20 centipoises. and paperboard and limited to use at a level not to exceed 0.075 percent by weight of the finished paper and paper- board. 3. Weight ratio: 80±2.5±17.5. The finished resin in a 0.30 For use only as a drainage and/or retention aid employed prior percent by weight aqueous solution has a minimum vis- to the sheet-forming operation in the manufacture of paper cosity of 50 centipoises. and paperboard and limited to use at a level not to exceed 0.075 percent by weight of the finished paper and 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 50± 2.5±47.5, 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 47.8± 2.2±2.5±47.5, so that the finished resin in a 1 percent by weight aqueous solution has a minimum viscosity of 22 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. 2,5-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). Diethyl(2-hydroxyethyl) methylammonium methyl sulfate, acry- For use only as a retention aid and drainage aid employed late, polymer with acrylamide, chemical abstract service reg- prior to the sheet-forming operation in the manufacture of istry No. [26796±75±8] having 90±95 mole pct. acrylamide, a paper and paperboard at a level not to exceed 0.15 pct. by nitrogen content of not more than 19.7 pct. (Kjeldahl, dry weight of finished dry paper and paperboard fibers. basis), and a residual acrylamide monomer content of not more than 0.1 pct. The finished polymer in a 1 pct. by weight aqueous solution has a minimum viscosity of 900 centipoises at 25 °C as determined by LVT-series Brookfield viscometer using a No. 2 spindle at 12 r.p.m. (or by equivalent method). Diethylenetriamine ...... For use only as a modifier for amino resins.
186
VerDate 06
List of Substances Limitations
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. 73347±80±5). lignocellulosic materials at levels not to exceed 0.1 percent by weight of the raw lignocellulosic materials. N,N′-Distearoylethylenediamine. n-Dodecylguanidine acetate ...... For use only as an antimicrobial agent in paper and 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. 111±30±8) ...... For use only as an antimicrobial agent in pigment and filler slurries used in the manufacture of paper and paperboard at levels not to exceed 300 parts per million by weight of the slurry solids. Glyceryl lactostearate. Glyceryl mono-1,2-hydroxystearate. Glyceryl monoricinoleate. Guar gum modified by treatment with 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.
187
VerDate 06
List of Substances Limitations
Guar gum modified by treatment with not more than 25 weight For use only as a retention aid and/or internal size employed percent of 2,3-epoxypropyltri-methylammonium chloride such prior to the sheet-forming operation in the manufacture of that the finished product has a maximum chlorine content of paper and paperboard, and limited to use at a level: (1) Not 4.5 percent, a maximum nitrogen content of 3.0 percent, and to exceed 0.15 percent by weight of the finished dry paper a minimum viscosity in 1-percent-by-weight aqueous solution and paperboard fibers intended for use in contact with all of 1,000 centipoises at 77 °F, as determined by RV-series types of foods, except (2) not to exceed 0.30 pct. by weight Brookfield viscometer (or equivalent) using a No. 3 spindle at of the finished dried paper and paperboard fibers for use 20 r.p.m. with nonalcoholic and nonfatty food of types identified under Types I, II, IV±B, VI±B, VII±B, and VIII of table I in par. (c) of this section. N, N, N′, N′, N′′, N′′-Hexakis (methoxymethyl)-1,3,5-triazine- 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. 130328±24±4). paper and paperboard will be used in contact with aqueous foods under conditions of use B through G as described in table 2 of paragraph (c) of this section. Hexamethylenetetramine ...... For use only as polymerization cross-linking agent for protein, including casein. Hydroquinone and the monomethyl or monoethyl ethers of hy- For use only as an inhibitor for monomers. droquinone. Hydroxypropyl guar gum having a minimum viscosity of 5,000 For use only as a dry strength and formation aid agent em- centipoises at 25 °C., as determined by RV-series Brookfield ployed prior to the sheet-forming operation in the manufac- viscometer using a No. 4 spindle at 20 r.p.m. (or other suit- ture of paper and paperboard and used at a level not to ex- able method) and using a test sample prepared by dissolving ceed 1.5 percent by weight of finished dry paper or paper- 5 grams of moisture-free hydroxypropyl guar gum in 495 mil- board fibers. liliters of a 70 percent by weight aqueous propylene glycol solution. 12-Hydroxystearic acid-polyethylene glycol block copolymers For use only as a surfactant for dispersions of polyacrylamide (CAS Reg. No. 70142±34±6) produced by the reaction of retention and drainage aids employed prior to the sheet polyethylene glycol (minimum molecular weight 200) with 12- forming operation in the manufacture of paper and paper- hydroxystearic acid. board. 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. 113221±69±5) and/or its ammo- forming operation to prevent scale buildup in the manufac- nium, potassium, and sodium salts. ture of paper and paperboard in contact with food, at a level not to exceed 0.075 percent (as the acid) by weight of the dry paper and paperboard. Methacrylic acid-acrylic acid copolymer (CAS Reg. No. 25751± For use only as a boiler water additive at a level not to exceed 21±7). 50 parts per million in the boiler water. N-methyldiallylamine hydrochloride polymer with For use only as a retention aid, flocculating agent, and wet- epichlorohydrin having a nitrogen content of 4.8 to 5.9 per- strength agent employed in the manufacture of paper and cent (Kjeldahl dry basis) such that a 20 percent by weight paperboard prior to the sheet-forming operation and limited aqueous solution has a minimum viscosity of 30 centipoises to use at a level not to exceed 1.5 percent by weight of the and maximum viscosity of 100 centipoises at 25 °C, as de- dry paper and paperboard. termined by LVF Model Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or equivalent method). Methyl naphthalene sulfonic acid-formaldehyde condensate, For use only as an adjuvant to control pulp absorbency and sodium salt. pitch content in the manufacture of paper and paperboard prior to the sheet-forming operation. N-methyl-N-(tall oil acyl) taurine, sodium salt (CAS Reg. No. For use only to control scale formation in the manufacture of 61791±41±1). paper and paperboard prior to the sheetforming operation at a level not to exceed 0.015 percent by weight of the dry paper and paperboard. Mineral oil, white. Mono-, di-, tri-(1-methyl-1-phenylethyl)-phenol, ethoxylated, For use only as an emulsifier for rosin based sizing at a level sulfated, ammonium salt with an average of 12 to 16 moles not to exceed 0.03 percent by weight of the finished dry of ethylene oxide (CAS Reg. No. 68130±71±2). paper and paperboard. Monoglyceride citrate. Mustardseed oil, sulfated, ammonium, potassium, or sodium salt.
188
VerDate 06
List of Substances Limitations
Naphthalene sulfonic acid-formaldehyde condensate, sodium For use only as an adjuvant to control pulp absorbency and salt. pitch content in the manufacture of paper and paperboard prior to the sheet-forming operation. Nitrocellulose, 10.9±12.2% nitrogen. Oleic acid, sulfated, ammonium, potassium, or sodium salt. N-Oleoyl-N′-stearoylethylenediamine. Oxystearin. Paraformaldehyde ...... For use only as setting agent for protein.
Pentanoic acid, 4,4±bis [(gamma-omega-perfluoro-C8±20- For use only as an oil and water repellent and used at a level alkyl)thio] derivatives, compounds with diethanolamine (CAS not to exceed 8 pounds per ton of the finished paper or pa- Reg. No. 71608±61±2). perboard when such paper or paperboard is used in contact with nonalcoholic foods under conditions of use E through H described in table 2 of paragraph (c) of this section. Perfluoroalkyl acrylate copolymer (CAS Reg. No. 92265±81±1) For use only as an oil and water repellent at a level not to ex- containing 35 to 40 weight percent fluorine, produced by the ceed 0.5 percent by weight of the finished paper and paper- copolymerization of ethanaminium, N,N,N-trimethyl-2-[(2- board in contact with nonalcoholic foods under conditions of methyl-1-oxo-2-propenyl)-oxy]-, chloride; 2-propenoic acid, 2- use C, D, E, F, G, or H described in table 2 of paragraph (c) methyl-, oxiranylmethyl ester; 2-propenoic acid, 2-ethoxyethyl of this section. ester; and 2-propenoic acid, 2[[(heptadecafluoro- octyl)sulfonyl] methyl amino]ethyl ester. Perfluoroalkyl substituted phosphate ester acids, ammonium For use only as an oil and water repellant at a level not to ex- salts formed by the reaction of 2,2-bis[ (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, IV±A, V, VII±A, 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 D36±76, ``Standard Test Method raw vegetables, and dry food of the type identified under for Softening Point of Bitumen (Ring-and-Ball Apparatus);'' Type VIII of table 1 in paragraph (c) of this section, and pro- penetration at 25° C not to exceed 0.3 mm, as determined vided that the asphalt is used at a level not to exceed 5% by by ASTM method D5±73 (Reapproved 1978), ``Standard weight of the finished dry paper and paperboard fibers. Test 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 thermal decomposition. Petroleum wax, synthetic ...... Complying with § 178.3720 of this chapter. Phenothiazine ...... For use only as antioxidant in dry rosin size. Phenyl acid phosphate ...... For use only as polymerization catalyst in melamine-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. 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.
189
VerDate 06
List of Substances Limitations
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. 53800±41±2), produced by react- agent employed prior to the sheet-forming operation in the ing 9.6±16.4 parts by weight of polyacrylamide with 1.6 parts manufacture of paper and paperboard at a level not to ex- dimethylamine and 1 part formaldehyde, and containing no ceed 0.25 percent by weight of finished dry paper and pa- more than 0.2% monomer as acrylamide, such that a 20% perboard fibers, when such paper or paperboard is used in aqueous solution has a minimum viscosity of 4,000 cP at 25 contact with fatty foods under conditions of use described in °C., as determined by Brookfield viscometer model RVT, paragraph (c) of this section, table 2, conditions of use E, F, using a No. 5 spindle at 20 r/min (or equivalent method). and G. Polyamide-epichlorohydrin modified resin produced by reacting For use only as a retention aid and flocculant employed prior adipic acid with diethylene triamine to produce a basic poly- to the sheet-forming operation in the manufacture of paper amide which is modified by reaction with formic acid and and paperboard and used at a level not to exceed 0.2 per- formaldehyde and further reacted with epichlorohydrin in the cent dry resin by weight of finished dry paper or paperboard presence of ammonium hydroxide to form a water-soluble fibers. cationic resin having a nitrogen content of 13±16 percent (Kjeldahl, dry basis) such that a 35 percent by weight 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. 68583±79±9] prepared by reacting adipic 1. As a retention aid employed prior to the sheet-forming oper- acid with diethylenetriamine to form a basic polyamide and ation in the manufacture of paper and paperboard and lim- further reacting the polyamide with an epichlorohydrin and ited to use at a level not to exceed 0.12 percent by weight of dimethylamine mixture such that the finished resins have a dry paper or paperboard. nitrogen content of 17.0 to 18.0 percent of a dry basis, and 2. The finished paper or paperboard will be used in contact that a 30-percent-by-weight aqueous solution has a minimum with food only of the types identified in paragraph (c) of this viscosity of 350 centipoises at 20 °C, as determined by a section, table 1, under types I and IV±B and under condi- Brookfield viscometer using a No. 3 spindle at 30 r.p.m. (or tions of use described in paragraph (c) of this section, table equivalent method). 2, conditions of use F and G. Polyamide-epichlorohydrin water-soluble thermosetting resin For use only as a wet strength agent and/or retention aid em- (CAS Reg. No. 96387±48±3) prepared by reacting N-methyl- ployed prior to the sheet-forming operation in the manufac- bis(3-aminopropyl) amine with oxalic acid and urea to form a ture of paper and paperboard and used at a level not to ex- basic polyamide and further reacting the polyamide with ceed 1.5 percent by weight of dry paper and paperboard fi- epichlorohydrin. bers. Polyamide-epichlorohydrin water-soluble thermosetting resins For use only in the manufacture of paper and paperboard prepared by reacting adipic acid, isophthalic acid, itaconic under conditions such that the resins do not exceed 1.5 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. Polyamidol-epichlorohydrin modified resin produced by reacting For use only as a wet strength agent employed prior to the glutaric acid dimethyl ester with diethylene-triamine to sheet-forming operation in the manufacture of paper and pa- produce a basic polyamide which is modified by reaction perboard, and used at a level not to exceed 2.5 percent by with formaldehyde and further reacted with epicholorohydrin weight of dry paper and paperboard fibers when such paper to form a water soluble cationic resin having a nitrogen con- or paperboard is used in contact with food under conditions tent of 10.9±11.9 percent and a chlorine content of 13.8± of use E through G described in table 2 of paragraph (c) of 14.8 percent, on a dry basis, and a minimum viscosity, in this section. 12.5 percent by weight aqueous solution, of 10 centipoises at 25° C, as determined by a Brookfield Model LVF 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).
190
VerDate 06
List of Substances Limitations
Polyamine-epichlorohydrin resin produced by the reaction of For use only as a clarifier in the treatment of influent water to N,N-dimethyl-1,3-propanediamine with epichlorohydrin and be used in the manufacture of paper and paperboard, and further reacted with sulfuric acid, Chemical Abstracts Service used at a level not to exceed 20 parts per million of the influ- Registry Number [27029±41±0], such that the finished resin ent water. has a maximum nitrogen content of 14.4 percent (dry basis) and a minimum viscosity in 30 percent by weight aqueous solution (pH 4±6) of 50 centipoises at 25 °C, as determined by Brookfield LVT model viscometer, using a No. 1 spindle at 12 r.p.m. (or equivalent method). Polyamine-epichlorohydrin water-soluble thermosetting resin For use only as a wetstrength agent and/or retention aid em- produced by reacting epichlorohydrin with: (i) polyamines ployed prior to the sheet-forming operation in the manufac- comprising at least 95 percent by weight C4 to C6 aliphatic ture of paper and paperboard, and used at a level not to ex- diamines and/or their self-condensation products, and/or (ii) ceed 1 percent by weight of dry paper and paperboard fi- prepolymers produced by reacting 1,2-dichloroethane with bers. the polyamines in (i). The finished resin has a nitrogen 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 5.0±5.3 percent; a chlorine content of 29.7±31.3 percent; and a phosphorus content of 2.0±2.2 percent, on a dry basis, and a minimum viscosity, in 25 percent by weight aqueous solution, of 50 centipoises at 25 °C., as determined on a Brookfield HAT model viscometer using a No. 1H spin- dle at 50 r.p.m. (or equivalent method). Polyamine resin produced by the reaction of 1,2-dichloroethane For use only as a retention aid and/or flocculent employed with bis(hexamethylene)triamine and higher homologues prior to the sheet-forming operation in the manufacture of such that the finished resin has a nitrogen content of 13.0± paper and paperboard and used at a level not to exceed 0.1 15.0 percent on a dry basis, and a minimum viscosity in 25- percent by weight of dry paper or paperboard fibers. percent-by-weight aqueous solution of 75 centipoises at 25 °C., as determined by Brookfield HAT model viscometer using a No. 1 spindle at 50 r.p.m. (or equivalent method). Polyaminoamide-epichlorohydrin modified resin produced by For use only as a wet-strength agent and/or retention aid em- reacting adipic acid with diethylenetriamine to produce a pol- ployed prior to the sheet-forming operation in the manufac- yamide which is modified by reaction with ture of paper and paperboard, and used at a level not to ex- diethylaminopropylamine and further reacted with dichlor- ceed 0.5 percent by weight of the finished dry paper and pa- oethyl ether to form a polyamide intermediate. This poly- perboard. amide intermediate is then reacted with epichlorohydrin such that the finished resins have a nitrogen content of 10.9±12.4 percent (Kjeldahl, dry basis) and a minimum viscosity in 40 percent-by-weight aqueous solution of 250 centipoises at 22 °C, as determined by a Brookfield Model LVT viscometer using a No. 2 spindle at 30 r.p.m. (or equivalent method). Polybutene, hydrogenated; complying with the identity pre- For use only as provided in §§ 175.300, 178.3740 and scribed under § 178.3740(b) of this chapter. 178.3860 of this chapter.
191
VerDate 06
List of Substances Limitations
Poly(diallyldimethylammonium chloride) (CAS Reg. No. 26062± For use only: 79±3) produced by the polymerization of 1. As a pigment dispersant and/or retention aid prior to the (diallyldimethylammonium chloride) so that the finished resin sheet-forming operation in the manufacture of paper and pa- has a nitrogen content of 8.66±0.4 percent on a dry weight perboard, and used at a level not to exceed 10 pounds of basis and a minimum viscosity in a 40 percent by weight active polymer per ton of finished paper and paperboard. aqueous solution of 1,000 centipoises at 25 °C (77 °F), de- 2. As a pigment dispersant in coatings at a level not to exceed termined by LVF Model Brookfield Viscometer using a No. 3 3.5 pounds of active polymer per ton of finished paper and spindle at 30 r.p.m. (or equivalent method). The level of re- paperboard. sidual monomer is not to exceed 1 percent by weight of the polymer (dry basis). Poly (diallyldimethylammonium chloride) (CAS Reg. No. For use only as a flocculant employed prior to the sheet-form- 26062±79±3) produced by the polymerization of ing operation in the manufacture of paper and paperboard, diallyldimethylammonium chloride so that the finished resin and used at a level not to exceed 10 mg/L (10 parts per mil- has a nitrogen content of 8.66±0.4 percent on a dry basis lion) of influent water. and a minimum viscosity in a 15 weight-percent aqueous 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. 4767±03±7) as a comonomer, at no more sheet-forming operation in the manufacture of paper and pa- than 30 percent by weight of total polymer solids in reaction perboard and limited to use at levels not to exceed 0.1 per- with 2,2-dimethyl-1,3-propanediol, phthalic anhydride and cent by weight of finished dry paper or paperboard. isophthalic acid, such that the polyester resin has a viscosity of 200±600 centipoises at 80 °F as determined by a Brook- field RVT viscometer using a number 3 spindle at 50 rpm (or equivalent method). Polyethylene, oxidized; complying with the identity prescribed For use only as component of coatings that contact food only in § 177.1620(a) of this chapter. of the type identified under Type VII±B of table 1 in 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. 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 125±325 centipoises at when used at a level not to exceed 0.3% by weight of coat- 25 °C as determined by LV-series Brookfield viscometer (or ing solids. equivalent) using a No. 2 spindle at 60 r.p.m. Polymethacrylic acid, sodium salt, having a viscosity in 40-per- For use only as a coating adjuvant for controlling viscosity cent-by-weight aqueous solution of 400±700 centipoises at when used at a level not to exceed 0.1% by weight of coat- 25 °C, as determined by LV-series Brookfield viscometer (or ing solids. equivalent) using a No. 2 spindle at 30 r.p.m.
192
VerDate 06
List of Substances Limitations
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 25° paperboard will contain the additive at a level not in excess C has a Stokes viscosity range of 2.5-4.0 as determined by of 1 percent by weight of the dry paper and paperboard. ASTM method D1545±76 (Reapproved; 1981), ``Standard Test Method for Viscosity of Transparent Liquids by Bubble Time Method,'' which is incorporated by reference. Copies may be obtained from the American Society for Testing Ma- terials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.. Poly[oxyethylene (dimethyliminio) ethylene (dimethyliminio) For use only to improve dry-strength of paper and paperboard ethylene dichloride] produced by reacting equimolar quan- and as a retention and drainage aid employed prior to the tities of N,N,N,N-tetramethylethylene-diamine and sheet-forming operation in the manufacture of paper and pa- dichlorethyl ether to yield a solution of the solid polymer in perboard and limited to use at a level not to exceed 0.1 per- distilled water at 25° C with a reduced viscosity of not less cent by weight of the finished dry paper and paperboard fi- than 0.15 deciliter per gram as determined by ASTM method bers. D1243±79, ``Standard Test Method for -Dilute Solution Vis- cosity of Vinyl Chloride Polymers,'' which is incorporated by reference. Copies may be obtained from the American Soci- ety for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Wash- ington, DC 20408). The following formula is used for 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. 110224±99±2). paperboard and at a level not to exceed 0.15 percent by weight of the dry paper and paperboard. Propylene glycol alginate. Protein hydrolysate from animal hides or soybean protein 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-C9±49-alkyl (CAS Reg. No. 144635±08±5). § 177.1520 of this chapter at a level not to exceed 3 percent by weight. The finished coating will be used only for paper and paperboard that contact food of types VI±A and VI±B of table 1 in paragraph (c) of this section, and under conditions of use C, D, and E, as described in table 2 in paragraph (c) of this section, with a maximum hot fill temperature of 200 °F (94 °C). Silver chloride-coated titanium dioxide ...... For use only as a preservative in polymer latex emulsions at a level not to exceed 2.2 parts per million (based on silver ion concentration) in the dry coating. Sodium carboxymethyl guar gum having a minimum viscosity For use only as a dry-strength and formation-aid agent em- of 2,700 centipoises at 25 °C after 24 hours as determined ployed prior to the sheet-forming operation in the manufac- by RV-series Brookfield viscometer (or equivalent) using a ture of paper and paperboard and used at a level not to ex- No. 4 spindle at 20 r.p.m. and using a test sample prepared ceed 1% by weight of finished dry paper or paperboard fi- by dissolving 8 grams of sodium carboxymethyl guar gum in bers. 392 milliliters of 0.2-percent-by-weight aqueous sodium o- phenylphenate solution. Sodium dioctyl sulfosuccinate. Sodium formaldehyde sulfoxylate ...... For use only as polymerization catalyst. Sodium hypochlorite. Sodium N-methyl-N-oleyltaurate ...... For use only as an adjuvant to control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet-forming operation.
193
VerDate 06
List of Substances Limitations
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. 118632± For use only in paper mill boilers. 18±1). Sodium zinc potassium polyphosphate (CAS Reg. No. 65997± For use only as a pigment dispersant in coatings at a level not 17±3). to exceed 1 percent by weight of pigment. Sperm oil, sulfated, ammonium, potassium, or sodium salt. Stannous oleate. Stearyl-2-lactylic acid and its calcium salt. Styrene-butadiene copolymers produced by copolymerizing 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. 53504±31±7). The finished copolymers shall contain not more than 10 weight percent of total polymer units derived from acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid, and methacrylic acid, and shall 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, IV±B, VI, VII±B and VIII as described in table 1 of paragraph (c) of this section. Tallow. Tallow alcohol. Tallow alcohol, hydrogenated. Tallow fatty acid, hydrogenated. Tallow hydrogenated. Tallow sulfated, ammonium, potassium, or sodium salt. Tetraethylenepentamine ...... For use only as a modifier for amino resins. 1,4,4a,9a-Tetrahydro-9, 10-anthracenedione (CAS Reg. No. For use only as a catalyst in the alkaline pulping of 56136±14±2). lignocellulosic materials at levels not to exceed 0.1 percent by weight of the raw lignocellulosic materials. N,N,N′, N′-Tetramethylethylenediamine polymer with bis-(2- For use only as a flocculent, drainage aid or retention aid em- chloroethyl) ether, first reacted with not more than 5 percent ployed prior to the sheet forming operation in the manufac- by weight 1-chloro-2,3-epoxypropane and then reacted with ture of paper and paperboard and limited to use at a level not more than 5 percent by weight poly (acrylic acid) such not to exceed 0.2 percent by weight of the finished dry paper that a 50 percent by weight aqueous solution of the product and paperboard fibers. has a nitrogen content of 4.7±4.9 percent and viscosity of 350±700 centipoises at 25 °C as determined by LV series Brookfield viscometer using a No. 2 spindle at 60 r.p.m. (or by other equivalent method).
194
VerDate 06
List of Substances Limitations
Tetrasodium N- (1,2-dicarboxyethyl) - N - octadecylsulfo±suc- For use only as an emulsifier in aqueous dispersions of rosin cinamate. sizes complying with § 178.3870(a)(4) of this chapter and limited to use prior to the sheet-forming operation in the manufacture of paper and paperboard at a level not to 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. 7779± For use only as an antimicrobial agent for coating, binder, pig- 27±3). ment, filler, sizing, and similar formulations added prior to the heat drying step in the manufacture of paper and 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. 68989±22±0) ...... 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.
List of substances Limitations
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. Acrylic and modified acrylic polymers ...... Complying with § 177.1010 of this chapter.
195
VerDate 06
List of substances Limitations
Acrylic copolymers produced by copolymerizing 2 or more of the acrylate monomers butyl acrylate, ethyl acrylate, ethyl methacrylate, methyl acrylate, methyl methacrylate, and n- propyl methacrylate, or produced by copolymerizing one or more of such acrylate monomers together with one or more of the monomers acrylic acid, acrylonitrile, butadiene, 2- ethyl-hexyl acrylate, fumaric acid, glycidyl methacrylate, n- hexyl-methacrylate, itaconic acid, methacrylic acid, styrene, vinyl acetate, vinyl chloride, and vinylidene chloride. The 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 C10±C18 with not less than 50 per- 1. As emulsifiers for vinylidene chloride copolymer coatings cent C14±C16).. and limited to use at levels not to exceed 2 percent by weight of the coating solids. 2. As emulsifiers for vinylidene chloride copolymer or homopolymer coatings at levels not to exceed a total of 2.6 percent by weight of coating solids. The finished 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, VI±B, and VIII. Castor Oil, polyoxyethylated (42 moles ethylene oxide) ...... For use only as an emulsifier in nitrocellulose coatings for paper and paperboard intended for use in contact with food only of the types identified in paragraph (c) of this section, table 1, under Types IV A, V, VII A, VIII, and IX; and limited to use at a level not to exceed 8 percent by weight of the coating solids. 1-(3-Chloroallyl)-3,5,7-triaza-1- azoniaadamantane chloride For use only: (CAS Reg. No. 4080±31±3). 1. As a preservative at a level of 0.3 weight percent in latexes used as pigment binders in paper and paperboard intended for use in contact with nonacidic, nonalcoholic food and under the conditions of use described in 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. 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172± For use only: 55±4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 1. As an antimicrobial agent for polymer latex emulsions in 2682±20±4) mixture at a ratio of 3 parts to 1 part, manufac- paper coatings at a level not to exceed 50 parts per mil- tured from methyl-3-mercaptopropionate (CAS Reg. No. lion (based on isothiazolone active ingredients) in the 2935±90±2). The mixture may contain magnesium nitrate coating formulation. (CAS Reg. No. 10377±60±3) at a concentration equivalent to 2. As an antimicrobial agent for finished coating formulations the isothiazolone active ingredients (weight/weight). and for additives used in the manufacture of paper and paperboard including fillers, binders, pigment slurries, and sizing solutions at a level not to exceed 25 parts per mil- lion (based on isothiazolone active ingredients) in the coating formulations and additives. Copper 8-quinolinolate ...... For use only as preservative for coating formulations.
196
VerDate 06
List of substances Limitations
Cyclized rubber produced when natural pale crepe rubber dis- For use only in coatings for paper and paperboard intended for solved in phenol is catalytically cyclized so that the finished use in contact with food only of the types identified in para- cyclized rubber has a melting point of 145 °C to 155 °C as graph (c) of this section, table 1, under Types VIII and IX. determined by ASTM method E28±67 (Reapproved 1982), ``Standard Test Method for Softening Point by Ring-and-Ball Apparatus,'' which is incorporated by reference (copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408), and 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 (HFS± 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. 35691±65±7) .. For use only as a preservative at levels not more than 0.05 weight percent and not less than 0.01 weight percent: in latexes used as pigment binders in coatings; in pigment slurries used in coatings; and/or in coatings themselves. The total level of the preservative in the finished coating shall not exceed 0.04 weight percent of the finished coating solids. Dibutyl phthalate. Dibutyl sebacate.
Di(C7,C9-alkyl) adipate ...... Complying with § 178.3740 of this chapter. Dicyclohexyl phthalate. Diethylene glycol dibenzoate (CAS Reg. No. 120±55±8) ...... For use only as a plasticizer for polyvinyl acetate coatings at a level not to exceed 5 percent by weight of the coating solids under conditions described in paragraph (c) of this section, table 2, conditions of use E, F, and G. Diethylene glycol ester of the adduct of terpene and maleic 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. 27138±31±4) ..... 1. For use only as a plasticizer for polyvinyl acetate coatings at a level not to exceed 5 percent by weight of the coating 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. 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 D1238±82, ``Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer,'' which is incorporated by reference. Copies may be obtained from the American Society for Testing Ma- terials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Formaldehyde ...... For use only as preservative for coating formulations.
197
VerDate 06
List of substances Limitations
Glyoxal ...... For use only as an insolubilizing agent in starch- and protein- based coatings that contact nonalcoholic foods, and limited to use at a level not to exceed 6 percent by weight of the starch or protein fraction of the coating solids. Glyceryl monobutyl ricinoleate. Hydroxymethyl derivatives (mixture of mono and poly) of [N-(1, For use only as a comonomer in polyvinyl acetate latex coat- 1-dimethyl-3-oxobutyl) acrylamide] produced by reacting 1 ings and limited to use at a level not to exceed 1 percent by mole of the [N-(1,1-dimethyl-3-oxobutyl) acrylamide] with 3 weight of dry polymer solids. moles of formaldehyde such that the finished product has a maximum nitrogen content of 6.2 percent and a maximum hydroxyl content of 15 percent by weight on a dry basis. Isobutyl oleate, sulfated, ammonium, potassium, or sodium salt. Maleic anhydride adduct of butadiene-styrene copolymer. α-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1α- methylstyrene to 3 vinyltoluene). Modified kaolin clay (CAS Reg. No. 1344±00±9) is produced For use only as a component of coatings in paper and paper- by the reaction of sodium silicate (CAS Reg. No. 1344±09± board products at a level not to exceed 9 percent by weight 8) and kaolinite clay (CAS Reg. No. 1332±58±7) under hy- of the coating intended for use in contact with food of Types drothermal conditions. The reaction product has a molecular I through IX described in table 1 of paragraph (c) of this sec- weight between 246 and 365 and consists of 46 to 55 per- tion under conditions of use C through H described in table cent silicon dioxide (Si02), 28 to 42 percent aluminum oxide 2 of paragraph (c) of this section. (A1203), and 2 to 7 percent of sodium oxide (Na20). The 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. 46236±15±1) For use only as a binder for pigment coatings as a binder level copolymer with ethyl acrylate and methyl methacrylate, and not to exceed 4.0 percent by weight of dry paper or paper- containing not more than 6 percent by weight of board. oxazolidinylethylmethacrylate. Maximum nitrogen content shall be 0.5 percent and number average molecular weight of that portion of the copolymer soluble in tetrahydrofuran shall be not less than 50,000. Pentaerythritol tetrastearate. Petroleum alicyclic hydrocarbon resins, or the hydrogenated For use only as modifiers in waxpolymer blend coatings for product thereof, meeting the following specifications: Soft- corrugated paperboard intended for use in bulk packaging or ening point 97 °C minimum, as determined by ASTM method raw fruits, raw vegetables, iced meat, iced fish, and iced E28±67 (Reapproved 1982), ``Standard Test Method for Soft- poultry; and limited to use at a level not to exceed 30 ening Point by Ring and Ball Apparatus;'' aniline point 120 weight-percent of the coating solids. °C minimum, as determined by ASTM method D611±82, ``Standard Test Methods for Aniline Point and Mixed Aniline Point of Petroleum Products and Hydrocarbon Solvents,'' which are incorporated by reference (copies may be 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 0.96±0.99 (20 °C/20 °C). Such petroleum hydrocarbon resins are produced by the catalytic polymerization of dienes and olefins from low-boiling distillates of cracked petroleum stocks that contain no material boiling over 200 °C and that meet the ultraviolet absorbance limits prescribed in § 172.880(b) of this chapter when subjected to the analytical procedure described in § 172.886(b) of this chapter, modified as follows: Treat the product as in the first paragraph under ``Procedure'' in § 172.250(b)(3) of this chapter. Then proceed with § 172.886(b) of this chapter, starting with the paragraph commencing with ``Promptly complete transfer of the sample ** *''. Polyester resin formed by the reaction of the methyl ester of rosin, phthalic anhydride, maleic anhydride and ethylene gly- col, such that the polyester resin has an acid number of 4 to 11, a drop-softening point of 70 °C±92 °C., and a color of K or paler. Polyester resin produced by reacting the acid groups in montan wax with ethylene glycol. Polyethylene, oxidized ...... Complying with § 177.1620 of this chapter. Polyethylene reacted with maleic anhydride such that the 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.
198
VerDate 06
List of substances Limitations
Polyoxypropylene-polyoxyethylene block polymers (minimum molecular weight 6,800). Polyvinyl acetate. Polyvinyl alcohol (minimum viscosity of 4% aqueous solution at 20 °C. of 4 centipoises). Polyvinyl butyral. Polyvinyl formal. Polyvinylidene chloride. Polyvinyl pyrrolidone. Polyvinyl stearate. Propylene glycol mono- and diesters of fats and fatty acids. Siloxanes and silicones; platinum-catalyzed reaction product of For use only as a surface coating. Platinum content not to ex- vinyl-containing dimethyl polysiloxane (CAS Reg. Nos. ceed 200 parts per million. 68083±19±2 and 68083±18±1) with methyl hydrogen 1. In coatings for paper and paperboard provided the coating polysiloxane (CAS Reg. No. 63148±57±2) or dimethyl (meth- contacts food only of the types identified in paragraph (c) of yl hydrogen) polysiloxane (CAS Reg. No. 68037±59±2). this section, table 1, under Types I, II, VI, and VII±B when Diallyl maleate (CAS Reg No. 999±21±3), dimethyl maleate used under conditions of use E, F, and G described in table (CAS Reg. No. 624±48±6), 1-ethynyl-1-cyclohexanol (CAS 2 of paragraph (c) of this section. Reg. No. 78±27±3) and vinyl acetate (CAS Reg. No. 108± 2. In coatings for paper and paperboard provided the coating 05±4) may be used as optional polymerization inhibitors. contacts food only of the types identified in paragraph (c) of this section, table 1, under Types III, IV, V, VII±A, VIII, and IX when used under conditions of use A through H 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. 68083±19±2 and 68083±18±1), with methyl hydrogen polysiloxane (CAS Reg. No. 63148±57±2). Dimethyl maleate (CAS Reg. No. 624±48±6), vinyl acetate (CAS Reg. No. 108±05±4), dibutyl maleate (CAS Reg. No. 105±76±0) and diallyl maleate (CAS Reg. No. 999±21±3) may be used as optional polymerization inhibitors. The polymer may also contain C16±C18 olefins (CAS Reg. No. 68855±60±7) as a control release agent. Sodium decylbenzenesulfonate. Sodium dihexyl sulfosuccinate. Sodium n-dodecylpolyethoxy (50 moles) sulfate-sodium For use only as an emulsifier in coatings that contact food only isododecylphenoxypolyethoxy (40 moles) sulfate mixtures. of the types identified in paragraph (c) of this section, table 1, under Types IV±A, V, VII, VIII, and IX; and limited to use at levels not to exceed 0.75 percent by weight of the coating solids. Sodium 2-ethylhexyl sulfate. Sodium oleoyl isopropanolamide sulfosuccinate. Sodium pentachlorophenate ...... For use only as preservative for coating formulations. Sodium o-phenylphenate ...... Do. Sodium vinyl sulfonate polymerized. 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 IV±A, V, and VII in tion of styrene or alpha methyl styrene with acrylic acid, table 1 of paragraph (c) of this section, under use conditions methacrylic acid, 2-ethyl hexyl acrylate, methyl methacrylate, E through G in table 2 of paragraph (c), and with foods of and butyl acrylate. The styrene and alpha methyl styrene, in- Types VIII and IX without use temperature restriction. dividually, may constitute from 0 to 80 weight percent of the polymer. The other monomers, individually, may be from 0 to 40 weight percent of the polymer. The polymer number 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. 25950±40±7 pro- For use only as a component of coatings and limited to use at duced by polymerizing 77 to 83 parts by weight of styrene a level not to exceed 20 percent by weight of the coating with 13 to 17 parts of methyl methacrylate, 3 to 4 parts of solids. butyl methacrylate, 0.5 to 2.5 parts of methacrylic acid, and 0.1 to 0.3 part of butyl acrylate such that the finished 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.
199
VerDate 06
List of substances Limitations
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 D2503±82, ``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, IV±B, VI±B, VII±B, 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. Styrene-maleic anhydride copolymers ...... For use only as a coating or component of coatings and limited for use at a level not to exceed 2 percent by weight of paper or paperboard substrate. Styrene-methacrylic acid copolymers containing no more than 5 weight percent of polymer units derived from methacrylic acid. Styrene-vinylidene chloride copolymers containing not more For use only as coatings or components of coatings. than 40 weight percent of vinylidene chloride in the finished copolymers. The finished copolymers may contain not more than 5 weight percent of total polymer units derived from acrylic acid, fumaric acid, itaconic acid, and/or methacrylic acid. 2-Sulfoethyl methacrylate, sodium salt [Chemical Abstracts For use only in copolymer coatings under conditions of use E, Service No. 1804±87±1]. F, and G described in paragraph (c) of this section, table 2, and limited to use at a level not to exceed 2.0 percent by weight of the dry copolymer coating. 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, 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. 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.
200
VerDate 06
List of substances Limitations
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. 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.
201
VerDate 06
List of substances Limitations
Calcium carbonate ...... Do. Calcium silicate ...... Do. Calcium sulfate ...... Do. Carbon black (channel process) ...... Do. Cobalt aluminate ...... Do. Diatomaceous earth ...... Do. Iron oxides ...... Do. Magnesium oxide ...... Do. Magnesium silicate (talc) ...... Do. Phthalocyanine blue (C.I. pigment blue 15, 15:1, 15:2, Do. 15:3, and 15:4; C.I. No. 74160; CAS Reg. No. 147±14± 8). Raw sienna ...... Do. Silica ...... Do. Tartrazine lake (certified FD&C Yellow No. 5 only) ...... Do. Titanium dioxide ...... Do. Titanium dioxide-barium sulfate ...... Do. Titanium dioxide-magnesium ...... Do. silicate. Zinc carbonate ...... Do. Zinc oxide ...... Do.
(c) The food-contact surface of the TABLE 1ÐTYPES OF RAW AND PROCESSED paper and paperboard in the finished FOODSÐContinued form in which it is to contact food, II. Acid, aqueous products; may contain salt or sugar or when extracted with the solvent or sol- both, and including oil-in-water emulsions of low- or high- fat content. vents characterizing the type of food, III. Aqueous, acid or nonacid products containing free oil or and under conditions of time and tem- fat; may contain salt, and including water-in-oil emulsions perature characterizing the conditions of low- or high-fat content. of its intended use as determined from IV. Dairy products and modifications: A. Water-in-oil emulsions, high- or low-fat. tables 1 and 2 of this paragraph, shall B. Oil-in-water emulsions, high- or low-fat. yield net chloroform-soluble extrac- V. Low-moisture fats and oil. tives (corrected for wax, petrolatum, VI. Beverages: mineral oil and zinc extractives as zinc A. Containing up to 8 percent of alcohol. oleate) not to exceed 0.5 milligram per B. Nonalcoholic. C. Containing more than 8 percent alcohol. square inch of food-contact surface as VII. Bakery products other than those included under Types determined by the methods described VIII or IX of this table: in paragraph (d) of this section. A. Moist bakery products with surface containing free fat or oil. TABLE 1ÐTYPES OF RAW AND PROCESSED B. Moist bakery products with surface containing no free fat or oil. FOODS VIII. Dry solids with the surface containing no free fat or oil I. Nonacid, aqueous products; may contain salt or sugar or (no end test required). both (pH above 5.0). IX. Dry solids with the surface containing free fat or oil. TABLE 2ÐTEST PROCEDURES WITH TIME TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF EXTRACTIVES FROM THE FOOD-CONTACT SURFACE OF UNCOATED OR COATED PAPER AND PAPER- BOARD, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES
Food-simulating solvents 8 percent al- 50 percent al- Types of food Water Heptane 1 Condition of use (see table 1) cohol cohol Time and Time and Time and Time and tem- temperature temperature temperature perature
A. High temperature heat-sterilized (e.g., I, IV±B, VII±B ..... 250 °F, 2 hr ...... over 212 °F). III, IV±A, VII±A ...... do ...... 150 °F, 2 hr ...... B. Boiling water sterilized ...... II, VII±B ...... 212 °F, 30 ...... min. III, VII±A ...... do ...... 120 °F, 30 ...... min. C. Hot filled or pasteurized above 150 °F .... II, IV±B, VII±B .... Fill boiling, ...... cool to 100 °F.
202
VerDate 06
TABLE 2ÐTEST 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 BEVERAGESÐContinued
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
III, IV±A, VII±A ...... do ...... 120 °F, 15 ...... min. V, IX ...... do ...... D. Hot filled or pasteurized below 150 °F ..... II, IV±B, VI±B, ...... VII±B ...... 150 °F, 2 hr ...... III, IV±A, VII±A ...... do ...... 100 °F, 30 ...... min. V, IX ...... do ...... VI±A ...... 150 °F, 2 hr ...... VI±C ...... 150 °F, 2 hr. E. Room temperature filled and stored (no I, II, IV±B, VI±B, 120 °F, 24 hr ...... thermal treatment in the container). VII±B. III, IV±A, VII±A ...... do ...... 70 °F, 30 ...... min. V, IX ...... do ...... VI±A ...... 120 °F, 24 hr ...... VI±C ...... 120 °F, 24 hr. F. Refrigerated storage (no thermal treat- III, IV±A, VII±A ... 70 °F, 48 hr 70 °F, 30 ...... ment in the container). min. I, II, IV±B, VI±B, ...... do ...... VII±B. VI±A ...... 70 °F, 48 hr ...... VI±C ...... 70 °F, 48 hr. G. Frozen storage (no thermal treatment in I, II, IV±B, VII±B 70 °F, 24 hr ...... the container). III, VII±A ...... do ...... 70 °F, 30 ...... min. H. Frozen or refrigerated storage: Ready- prepared foods intended to be reheated in container at time of use: 1. Aqueous or oil-in-water emulsion of I, II, IV±B, VII±B 212 °F, 30 ...... high- or low-fat. min. 2. Aqueous, high- or low-free oil or fat .. III, IV±A, VII±A, ...... do ...... 120 °F, 30 ...... IX. min. 1 Heptane extractability results must be divided by a factor of five in arriving at the extractability for a food product having water-in-oil emulsion or free oil or fat. Heptane food-simulating solvent is not required in the case of wax-polymer blend coatings for corrugated paperboard containers intended for use in bulk packaging of iced meat, iced fish, and iced poultry.
(d) Analytical methods—(1) Selection of freshly demineralized (deionized) dis- extractability conditions. First ascertain tilled water. the type of food product (table 1, para- (ii) n-Heptane. Reagent grade, freshly graph (c) of this section) that is being redistilled before use, using only mate- packed commercially in the paper or rial boiling at 208 °F. paperboard and the normal conditions (iii) Alcohol. 8 or 50 percent (by vol- of thermal treatment used in pack- ume), prepared from undenatured 95 aging the type of food involved. Using percent ethyl alcohol diluted with table 2, paragraph (c) of this section, demineralized (deionized) distilled select the food-simulating solvent or water. solvents and the time-temperature ex- (iv) Chloroform. Reagent grade, fresh- aggerations of the paper or paperboard ly redistilled before use, or a grade use conditions. Having selected the ap- having an established consistently low propriate food-simulating solvent or blank. solvents and the time-temperature ex- (3) Selection of test method. Paper or aggeration over normal use, follow the paperboard ready for use in packaging applicable extraction procedure. shall be tested by use of the extraction (2) Reagents—(i) Water. All water used cell described in ‘‘Official Methods of in extraction procedures should be Analysis of the Association of Official
203
VerDate 06
Analytical Chemists,’’ 13th Ed. (1980), (i) Five 21⁄2-inch-square aluminum sections 21.010–21.015, under ‘‘Exposing screens (standard aluminum window Flexible Barrier Materials for Extrac- screening is acceptable). tion,’’ which is incorporated by ref- (j) One wire capable of supporting erence (copies may be obtained from sample stack. the Association of Official Analytical (ii) Procedure. (a) For each extrac- Chemists International, 481 North tion, accurately cut eight 21⁄2-inch- Frederick Ave., suite 500, Gaithersburg, square samples from the formed paper MD 20877–2504, or may be examined at or paperboard product to be tested. the Office of the Federal Register, 800 (b) Carefully stack the eight 21⁄2-inch- North Capitol Street, NW., suite 700, square samples and the five 21⁄2-inch- Washington, DC 20408); also described square aluminum screens in sandwich in ASTM method F34–76 (Reapproved form such that the food-contact side of 1980), ‘‘Standard Test Method for Liq- each sample is always next to an alu- uid Extraction of Flexible Barrier Ma- minum screen, as follows: Screen, sam- terials,’’ which is incorporated by ref- ple, sample, screen, sample, sample, erence (copies may be obtained from screen, etc. Clip the sandwich together the American Society for Testing Ma- carefully with a No. 2 paper clip, leav- terials, 1916 Race St., Philadelphia, PA ing just enough space at the top to slip 19103, or may be examined at the Office a wire through. of the Federal Register, 800 North Cap- (c) Place an 800-milliliter beaker con- itol Street, NW., suite 700, Washington, taining 100-milliliters of the appro- DC 20408), except that formed paper and priate food-simulating solvent into the paperboard products may be tested in constant temperature bath, cover with the container by adapting the in-con- a watch glass and condition at the de- tainer methods described in § 175.300(e) sired temperature. of this chapter. Formed paper and pa- (d) After conditioning, carefully perboard products such as containers lower the sample sandwich with tongs and lids, that cannot be tested satisfac- into the beaker. torily by any of the above methods (e) At the end of the extraction pe- may be tested in specially designed ex- riod, using the tongs, carefully lift out traction equipment, usually consisting the sample sandwich and hang it over of clamping devices that fit the closure the beaker with the wire. or container so that the food-contact (f) After draining, pour the food-sim- surface can be tested, or, if flat sam- ulating solvent solution into a tared ples can be cut from the formed paper 250-milliliter beaker. Rinse the 800-mil- or paperboard products without de- liliter beaker three times, using a total stroying the integrity of the food-con- of not more than 50 milliliters of the tact surface, they may be tested by required solvent. adapting the following ‘‘sandwich’’ (g) Determine total nonvolatile ex- method: tractives in accordance with paragraph (i) Apparatus. (a) Thermostated (±1.0 (d)(5) of this section. °F) water bath, variable between 70 °F (4) Selection of samples. Quadruplicate and 120 °F water bath cover capable of samples should be tested, using for holding at least one 800-milliliter beak- each replicate sample the number of er partially submersed in bath. cups, containers, or preformed or con- (b) Analytical balance sensitive to 0.1 verted products nearest to an area of milligram with an approximate capac- 100 square inches. ity of 100 grams. (5) Determination of amount of extrac- (c) Tongs. tives—(i) Total residues. At the end of (d) Hood and hot-plate facilities. the exposure period, remove the test (e) Forced draft oven. container or test cell from the oven and combine the solvent for each rep- For each extraction, the following ad- licate in a clean Pyrex (or equivalent) ditional apparatus is necessary: flask or beaker being sure to rinse the (f) One No. 2 paper clip. test container or cell with a small (g) One 800-milliliter beaker with quantity of clean solvent. Evaporate watch-glass cover. the food-simulating solvents to about (h) One 250-milliliter beaker. 100 milliliters in the flask or beaker,
204
VerDate 06
and transfer to a clean, tared evaporate the total down to a few mil- evaporating dish (platinum or Pyrex), liliters on a low-temperature hotplate. washing the flask three times with The last few milliliters should be evap- small portions of solvent used in the orated in an oven maintained at ap- extraction procedure, and evaporate to proximately 221 °F. Cool the a few milliliters on a nonsparking, low- evaporating dish in a desiccator for 30 temperature hotplate. The last few minutes and weigh to the nearest 0.1 milliliters should be evaporated in an milligram to get the chloroform-solu- oven maintained at a temperature of ble extractives residue (′). This ′ is sub- approximately 221 °F. Cool the stituted for e in the equations in para- evaporating dish in a desiccator for 30 graph (d)(5)(i) (a) and (b) of this sec- minutes and weigh the residue to the tion. If the chloroform-soluble extrac- nearest 0.1 milligram, (e). Calculate the tives in milligrams per square inch extractives in milligrams per square still exceeds the limitation prescribed inch of the container or sheeted paper in paragraph (c) of this section, proceed or paperboard surface. to paragraph (d)(5)(iii) of this section (a) Water and 8- and 50-percent alcohol. (method for determining corrected Milligrams extractives per square chloroform-soluble extractives res- inch=(e)/(s). (b) Heptane. Milligrams extractives idue). per square inch=(e)/(s)(F) (iii) Corrected chloroform-soluble ex- tractives residue—(a) Correction for zinc where: extractives. Ash the residue in the e=Milligrams extractives per sample tested. evaporating dish by heating gently s=Surface area tested, in square inches. F=Five, the ratio of the amount of extrac- over a Meker-type burner to destroy tives removed by heptane under exagger- organic matter and hold at red heat for ated time-temperature test conditions about 1 minute. Cool in the air for 3 compared to the amount extracted by a minutes, and place the evaporating fat or oil under exaggerated conditions of dish in the desiccator for 30 minutes thermal sterilization and use. and weigh to the nearest 0.1 milligram. e′=Chloroform-soluble extractives residue. ee′=Corrected chloroform-soluble extractives Analyze this ash for zinc by standard residue. Association of Official Agricultural e′ or ee′ is substituted for e in the above equa- Chemists methods or equivalent. Cal- tions when necessary. culate the zinc in the ash as zinc ole- ate, and subtract from the weight of If when calculated by the equations in chloroform-soluble extractives residue paragraph (d)(5)(i) ( ) and ( ) of this a b (′) to obtain the zinc-corrected chloro- section, the extractives in milligrams form-soluble extractives residue (e′). per square inch exceeds the limitations This e′ is substituted for e in the equa- prescribed in paragraph (c) of this sec- tions in paragraph (d)(5)(i) (a) and (b) of tion, proceed to paragraph (d)(5)(ii) of this section. this section (method for determining the amount of chloroform-soluble ex- (b) Correction for wax, petrolatum, and tractives residues). mineral oil—(1) Apparatus. Standard 10 (ii) Chloroform-soluble extractives res- millimeter inside diameter × 60 centi- idue. Add 50 milliliters of chloroform meter chromatographic column (or (freshly distilled reagent grade or a standard 50-milliliter buret with an in- grade having an established consist- side diameter of 10–11 millimeters) ently low blank) to the dried and with a stopcock of glass, weighed residue, (e), in the evaporating perfluorocarbon resin, or equivalent dish obtained in paragraph (d)(5)(i) of material. The column (or buret) may this section. Warm carefully, and filter be optionally equipped with an integral through Whatman No. 41 filter paper coarse, fritted glass disc and the top of (or equivalent) in a Pyrex (or equiva- the column (or buret) may be option- lent) funnel, collecting the filtrate in a ally fitted with a 100-millimeter sol- clean, tared evaporating dish (platinum vent reservoir. or Pyrex). Repeat the chloroform ex- (2) Preparation of column. Place a traction, washing the filter paper with snug pledget of fine glass wool in the this second portion of chloroform. Add bottom of the column (or buret) if the this filtrate to the original filtrate and column (or buret) is not equipped with
205
VerDate 06
integral coarse, fritted glass disc. Over- the evaporating dish to dryness on a lay the glass wool pledget (or fritted steam bath. Dry the residue for 15 min- glass disc) with a 15–20 millimeter deep utes in an oven maintained at a tem- layer of fine sand. Measure in a grad- perature of approximately 221 °F. Cool uated cylinder 15 milliliters of the evaporating dish in a desiccator for chromatographic grade aluminum 30 minutes and weigh the residue to the oxide (80–200 mesh) that has been tight- nearest 0.1 milligram. Subtract the ly settled by tapping the cylinder. weight of the residue from the weight Transfer the aluminum oxide to the of chloroform-soluble extractives res- chromatographic tube, tapping the idue (′) to obtain the wax-, petrolatum- tube during and after the transfer so as , and mineral oil-corrected chloroform- to tightly settle the aluminum oxide. soluble extractives residue (e′). This e′ Overlay the layer of aluminum oxide is substituted for e in the equations in with a 1.0–1.5 centimeter deep layer of paragraph (d)(5)(i) (a) and (b) of this anhydrous sodium sulfate and on top of section. this place an 8–10 millimeter thick plug of fine glass wool. Next carefully add (ii) For chloroform residues weighing about 25 milliliters of heptane to the more than 0.5 gram. Redissolve the column with stopcock open, and allow dried and weighed chloroform-soluble the heptane to pass through the col- extract residue as described in para- umn until the top level of the liquid graph (d)(5)(iii)(b)(3)(i) of this section just passes into the top glass wool plug using proportionately larger quantities in the column, and close stopcock. of heptane. Transfer the heptane solu- (3) Chromatographing of sample ex- tion to an appropriate-sized volumetric tract—(i) For chloroform residues weigh- flask (i.e., a 250-milliliter flask for ing 0.5 gram or less. To the dried and about 2.5 grams of residue) and adjust weighed chloroform-soluble extract to volume with additional heptane. Pi- residue in the evaporating dish, ob- pette out an aliquot (about 50 milli- tained in paragraph (d)(5)(ii) of this liters) calculated to contain 0.1–0.5 section, add 20 milliliters of heptane gram of the chloroform-soluble extract and stir. If necessary, heat carefully to residue and analyze dissolve the residue. Additional chromatographically as described in heptane not to exceed a total volume of paragraph (d)(5)(iii)(b)(3)(i) of this sec- 50 milliliters may be used if necessary tion. In this case the weight of the to complete dissolving. Cool to room dried residue from the heptane eluate temperature. (If solution becomes must be multiplied by the dilution fac- cloudy, use the procedure in paragraph tor to obtain the weight of wax, petro- (d)(5)(iii)(b)(3)(ii) of this section to ob- latum, and mineral oil residue to be tain an aliquot of heptane solution cal- subtracted from the weight of chloro- culated to contain 0.1–0.5 gram of chlo- form-soluble extractives residue (′) to roform-soluble extract residue.) Trans- obtain the wax-, petrolatum-, and min- fer the clear liquid solution to the col- eral oil-corrected chloroform-soluble umn (or buret). Rinse the dish with 10 extractives residue (e′). This e′ is sub- millimeters of additional heptane and stituted for e in the equations in para- add to column. Allow the liquid to pass graph (d)(5)(i) (a) and (b) of this sec- through the column into a clean, tared tion. (Note: In the case of chloroform- evaporating dish (platinum or Pyrex) at a dropwise rate of about 2 milliliters soluble extracts which contain high per minute until the liquid surface melting waxes (melting point greater ° reaches the top glass wool plug; then than 170 F), it may be necessary to di- close the stopcock temporarily. Rinse lute the heptane solution further so the Pyrex flask which contained the that a 50-milliliter aliquot will contain filtrate with an additional 10–15 milli- only 0.1–0.2 gram of the chloroform- liters of heptane and add to the col- soluble extract residue.) umn. Wash (elute) the column with (e) Acrylonitrile copolymers identi- more heptane collecting about 100 mil- fied in this section shall comply with liliters of total eluate including that the provisions of § 180.22 of this chap- already collected in the evaporating ter, except where the copolymers are dish. Evaporate the combined eluate in restricted to use in contact with food
206
VerDate 06
only of the type identified in paragraph subject to the provisions of this sec- (c), table 1 under Category VIII. tion. (a) The substances are used in [42 FR 14554, Mar. 15, 1977] amounts not to exceed that required to EDITORIAL NOTE: For FEDERAL REGISTER ci- accomplish their intended physical or tations affecting § 176.170, see the List of CFR technical effect, and are so used as to Sections Affected in the Finding Aids sec- accomplish no effect in food other than tion of this volume. that ordinarily accomplished by pack- aging. § 176.180 Components of paper and pa- (b) The substances permitted to be perboard in contact with dry food. used include the following: The substances listed in this section (1) Substances that by § 176.170 and may be safely used as components of other applicable regulations in parts the uncoated or coated food-contact 170 through 189 of this chapter may be surface of paper and paperboard in- safely used as components of the tended for use in producing, manufac- uncoated or coated food-contact sur- turing, packing, processing, preparing, face of paper and paperboard, subject treating, packaging, transporting, or to the provisions of such regulation. holding dry food of the type identified (2) Substances identified in the fol- in § 176.170(c), table 1, under Type VIII, lowing list:
List of substances Limitations
(2-Alkenyl) succinic anhydrides in which the alkenyl groups are derived from olefins which contain not less than 78 percent C30 and higher groups (CAS Reg. No. 70983±55±0). 4-[2-[2-(2-Alkoxy(C12±C15) ethoxy) ethoxy]ethyl]disodium sulfo- For use as a polymerization emulsifier and latex emulsion sta- succinate. bilizer at levels not to exceed 5 percent by weight of total emulsion solids. Alkyl mono- and disulfonic acids, sodium salts (produced from n-alkanes in the range of C10±C18 with not less than 50 per- cent C14±C16).. Aluminum and calcium salts of FD & C dyes on a substrate of Colorant. alumina. Ammonium nitrate. Amylose. Barium metaborate ...... For use as preservative in coatings and sizings. 1,2-Benzisothiazolin-3-one (CAS Registry No. 2634±33±5) ...... For use only as a preservative in paper coating compositions and limited to use at a level not to exceed 0.02 mg/in2 (0.0031 mg/cm2) of finished paper and paperboard. N,N′-Bis(hydroxyethyl)lauramide. Bis(trichloromethyl) sulfone C.A. Registry No. 3064±70±8 ...... For use only as a preservative in coatings. Borax ...... For use as preservative in coatings. Boric acid ...... Do. sec-Butyl alcohol. Butyl benzyl phthalate. Candelilla wax. Carbon tetrachloride. Castor oil, polyoxyethylated (42 moles ethylene oxide). Cationic soy protein hydrolyzed (hydrolyzed soy protein isolate For use only as a coating adhesive, pigment structuring agent, modified by treatment with 3-chloro-2-hydroxypropyl- and fiber retention aid. trimethylammonium chloride). Cationic soy protein (soy protein isolate modified by treatment For use only as a coating adhesive, pigment structuring agent, with 3-chloro-2-hydroxypropyltrimethyl-ammonium chloride). and fiber retention aid. Chloral hydrate ...... Polymerization reaction-control agent. N-Cyclohexyl-p-toluene sulfonamide. 2,5-Di-tert-butyl hydroquinone. Diethanolamine. Diethylene glycol dibenzoate (CAS Reg. No. 120±55±8) ...... For use only as a plasticizer in polymeric substances. Diethylene glycol monobutyl ether. Diethylene glycol monoethyl ether. Diethylenetriamine. N,N-Diisopropanolamide of tallow fatty acids. N-[(dimethylamino)methyl]acrylamide polymer with acrylamide and styrene.
207
VerDate 06
List of substances Limitations
N,N-Dioleoylethylenediamine, N,N-dilinoeoyl-ethylenediamine, and N-oleoyl-N-linoleoyl-ethylenediamine mixture produced when tall oil fatty acids are made to react with ethylene- diamine such that the finished mixture has a melting point of 212°±228 °F, as determined by ASTM method D127±60, and an acid value of 10 maximum. ASTM Method D127±60 ``Standard Method of Test for Melting Point of Petrolatum and Microcrystalline Wax'' (Revised 1960) is incorporated by reference. Copies are available from University Microfilms International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Diphenylamine. Dipropylene glycol dibenzoate (CAS Reg. No. 27138±31±4) ..... For use only as plasticizer in polymeric substances. Disodium N-octadecylsulfosuccinamate. tert-Dodecyl thioether of polyethylene glycol ...... Erucamide (erucylamide). Ethanedial, polymer with tetrahydro-4-hydroxy-5-methyl- 2(1H)pyrimidinone, propoxylated. Ethylene oxide ...... Fumigant in sizing. Ethylene oxide adduct of mono-(2-ethylhexyl) o-phosphate. Fatty acid (C12±C18) diethanolamide. Fish oil fatty acids, hydrogenated, potassium salt. Formaldehyde. Glyceryl monocaprate. Glyceryl tribenzoate (CAS Reg. No. 614±33±5) ...... For use only as a plasticizer in polymeric coatings. Glyoxal. Glyoxal-urea-formaldehyde condensate (CAS Reg. No. 27013± For use as an insolubilizer for starch in coatings. 01±0) formed by reaction in the molar ratio of approximately 47:33:15, respectively. The reaction product has a number average molecular weight of 278±14 as determined by a suitable method. Glyoxal-urea polymer (CAS Reg. No. 53037±34±6) ...... For use as an insolubilizer for starch. Hexamethylenetetramine ...... Polymerization crosslinking agent for protein, including casein. As neutralizing agent with myristochromic chloride complex and stearato-chromic chloride complex. Hexylene glycol (2-methyl-2,4-pentanediol). Hydroabietyl alcohol. 5-Hydroxymethoxymethyl-1-aza-3,7-dioxabicyclo[3.3.0] octane, For use only as an antibacterial preservative. 5-hydroxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, and 5- hydroxypoly-[methyleneoxy]methyl-1-aza-3,7- dioxabicyclo[3.3.0] octane mixture. 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(N±1,2-dihydroxyethylene-1,3-imidazolidin±2± 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).
208
VerDate 06
List of substances Limitations
Mono- and di(2-alkenyl)succinyl esters of polyethylene glycol For use only as an emulsifier. containing not less than 90 percent of the diester product and in which the alkenyl groups are derived from olefins that contain not less than 95 percent of C15±C21 groups. Monoglyceride citrate. Myristo chromic chloride complex. Napthalene sulfonic acid-formaldehyde condensate, sodium salt. Nickel. 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. 68412± pounds per ton of paper. 14±6), and the acetate salts thereof (CAS Reg. No. 68784± 21±4), which may be emulsified with ethoxylated tallow alkyl amines (CAS Reg. No. 61791±26±2). 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-(C16±C18) trimethylenediamine. Oxidized soy isolate having 50 to 70 percent of its cystine resi- For use as a binder adhesive component of coatings. dues oxidized to cysteic acid. Petroleum alicyclic hydrocarbon resins, or the hydrogenated For use as modifiers at levels up to 30 weight-percent of the product thereof, complying with the identity prescribed in solids content of wax-polymer blend coatings. § 176.170(b)(2). Petroleum hydrocarbon resins (produced by the catalytic 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 11±15 percent and chlorine level of 20±23 percent on a dry basis. Polyamide-ethyleneimine-epichlorohydrin resin is prepared by reacting equimolar amounts of adipic acid and three amines (21 mole percent of 1,2-ethanediamine, 51 mole percent of N-(2-aminoethyl)-1,3-propanediamine, and 28 mole percent of N, N′-1,2-ethanediylbis(1,3-propanediamine)) to form a basic polyamidoamine which is modified by reaction with ethyleneimine (5.5:1.0 ethyleneimine:polyamidoamine). The modified polyamidoamine is reacted with a crosslinking agent made by condensing approximately 34 ethylene glycol units with (chloromethyl)oxirane, followed by pH adjustment with formic acid or sulfuric acid to provide a finished product as a formate (CAS Reg. No. 114133±44±7) or a sulfate (CAS Reg. No. 167678±43±5), having a weight-average mo- lecular weight of 1,300,000 and a number-average molecular weight of 16,000. Polyamide-ethyleneimine-epichlorohydrin resin (CAS Reg. No. 115340±77±7), prepared by reacting equimolar amounts of adipic acid and N-(2-aminoethyl)-1,2-ethanediamine to form a basic polyamidoamine which is modified by reaction with ethyleneimine, and further reacted with formic acid and (chloromethyl)oxirane-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. Polymers: Homopolymers and copolymers of the following Basic polymer. monomers: Acrylamide. Acrylic acid and its methyl, ethyl, butyl, propyl, or octyl esters. Acrylonitrile.
209
VerDate 06
List of substances Limitations
Butadiene. Crotonic acid. Cyclol acrylate. Decyl acrylate. Diallyl fumarate. Diallyl maleate. Diallyl phthalate. Dibutyl fumarate. Dibutyl itaconate. Dibutyl maleate. Di(2-ethylhexyl) maleate. Dioctyl fumarate. Dioctyl maleate. Divinylbenzene. Ethylene. 2-Ethylhexyl acrylate. Fumaric acid. Glycidyl methacrylate. 2-Hydroxyethyl acrylate. N-(Hydroxymethyl) acrylamide. Isobutyl acrylate. Isobutylene. Isoprene. Itaconic acid. Maleic anhydride and its methyl or butyl esters. Methacrylic acid and its methyl, ethyl, butyl, or propyl esters. Methylstyrene. Mono(2-ethylhexyl) maleate. Monoethyl maleate. 5-Norbornene-2,3-dicarboxylic acid, mono-n-butyl ester. Styrene. Vinyl acetate. Vinyl butyrate. Vinyl chloride. Vinyl crotonate. Vinyl hexoate. Vinylidene chloride. Vinyl pelargonate. Vinyl propionate. Vinyl pyrrolidone. Vinyl stearate. Vinyl sulfonic acid. Polymer prepared from urea, ethanedial, formaldehyde, and For use only as a starch and protein reactant in paper and pa- propionaldehyde (CAS Reg. No. 106569±82±8). perboard coatings. Polyoxyethylene (minimum 12 moles) ester of tall oil (30%± 40% rosin acids). Polyoxypropylene-polyoxyethylene glycol (minimum molecular weight 1,900). Polyvinyl alcohol. Potassium titanate fibers produced by calcining titanium diox- ide, potassium chloride, and potassium carbonate, such that the finished crystalline fibers have a nominal diameter of 0.20±0.25 micron, a length-to-diameter ratio of approximately 25:1 or greater, and consist principally of K2Ti4O9 and K2Ti 6O13. Sodium diisobutylphenoxy diethoxyethyl sulfonate. Sodium diisobutylphenoxy monoethoxy ethylsulfonate. Sodium n-dodecylpolyethoxy (50 moles) sulfate. Sodium isododecylphenoxypolyethoxy (40 moles) sulfate. Sodium N-methyl-N-oleyl taurate. Sodium methyl siliconate. 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 6±9 or 40 moles.
210
VerDate 06
List of substances Limitations
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. 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 in the Finding Aids section of this volume.
§ 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.
211
VerDate 06
List of substances Limitations
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. 9014±93±1).. weight of the finished coating. Dipropylene glycol. Ethyl alcohol. Fats and oils derived from animal, marine, or vegetable sources: Fatty acids derived from animal, marine, or vegetable fats and oils, and salts of such acids, single or mixed, as follows: Aluminum.. Ammonium.. Calcium.. Magnesium.. Potassium.. Sodium.. Zinc.. Formaldehyde ...... For use as preservative of defoamer only. Glyceryl mono-12-hydroxystearate. Glyceryl monostearate. Hexane. Hexylene glycol (2-methyl-2,4-pentanediol). Isobutyl alcohol. Isopropyl alcohol. Kerosene. Lecithin hydroxylated. Methyl alcohol. Methylcellulose. Methyl esters of fatty acids derived from animal, marine, or vegetable fats and oils. Methyl oleate. Methyl palmitate. Mineral oil. Mustardseed oil, sulfated, ammonium, potassium, or sodium salt. Myristyl alcohol. Naphtha. 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).
212
VerDate 06
List of substances Limitations
Polyoxypropylene (min. 20 mols) oleate butyl ether. Polyoxypropylene-polyoxyethylene glycol (min. mol. wt. 1,900). Polyoxypropylene (min. 40 mols) stearate butyl ether. Potassium pentachlorophenate ...... For use as preservative of defoamer only. Potassium trichlorophenate ...... Do. Propylene glycol monoester of soybean oil fatty acids. Propylene glycol monoester of tallow fatty acids. Ricebran oil, sulfated, ammonium, potassium, or sodium salt. Rosins and rosin derivatives ...... As provided in § 178.3870 of this chapter. Silica. Sodium 2-mercaptobenzothiazole ...... For use as preservative of defoamer only. Sodium pentachlorophenate ...... Do. Sodium trichlorophenate ...... Do. Sperm oil, sulfated, ammonium, potassium, or sodium salt. Stearyl alcohol. Tall oil fatty acids. Tallow fatty acids, hydrogenated or sulfated. Tallow, sulfated, ammonium, potassium, or sodium salt. Triethanolamine. Triisopropanolamine. Waxes, petroleum.
(e) The defoaming agents are used as (d) Substances permitted to be used follows: in the formulation of defoaming agents (1) The quantity of defoaming agent include substances subject to prior or agents used shall not exceed the sanctions or approval for such use and amount reasonably required to accom- employed subject to the conditions of plish the intended effect, which is to such sanctions or approvals, substances prevent or control the formation of generally recognized as safe for use in foam. food, substances generally recognized (2) The defoaming agents are used in as safe for use in paper and paperboard, the preparation and application of and substances listed in this para- coatings for paper and paperboard. graph, subject to the limitations, if any, prescribed. [42 FR 14554, Mar. 15, 1977, as amended at 62 (1) Fatty triglycerides, and the fatty FR 39772, July 24, 1997] acids, alcohols, and dimers derived § 176.210 Defoaming agents used in the therefrom: manufacture of paper and paper- Beef tallow. board. Castor oil. Defoaming agents may be safely used Coconut oil. in the manufacture of paper and paper- Corn oil. Cottonseed oil. board intended for use in packaging, Fish oil. transporting, or holding food in accord- Lard oil. ance with the following prescribed con- Linseed oil. ditions: Mustardseed oil. (a) The defoaming agents are pre- Palm oil. pared from one or more of the sub- Peanut oil. stances named in paragraph (d) of this Rapeseed oil. Ricebran oil. section, subject to any prescribed limi- Soybean oil. tations. Sperm oil. (b) The defoaming agents are used to Tall oil. prevent or control the formation of foam during the manufacture of paper (2) Fatty triglycerides, and marine and paperboard prior to and during the oils, and the fatty acids and alcohols sheet-forming process. derived therefrom (paragraph (d)(1) of this section) reacted with one or more (c) The quantity of defoaming agent of the following, with or without dehy- or agents added during the manufac- dration, to form chemicals of the cat- turing process shall not exceed the egory indicated in parentheses: amount necessary to accomplish the intended technical effect. Aluminum hydroxide (soaps).
213
VerDate 06
Ammonia (amides). 2-Ethylhexanol. Butanol (esters). Ethylenediamine tetraacetic acid tetra- Butoxy-polyoxypropylene, molecular weight sodium salt. 1,000–2,500 (esters). Formaldehyde. Butylene glycol (esters). Heavy oxo-fraction (a still-bottom product of Calcium hydroxide (soaps). iso-octyl alcohol manufacture, of approxi- Diethanolamine (amides). mate composition: Octyl alcohol 5 percent Diethylene glycol (esters). nonyl alcohol 10 percent, decyl and higher Ethylene glycol (esters). alcohols 35 percent, esters 45 percent, and Ethylene oxide (esters and ethers). soaps 5 percent). Glycerin (mono- and diglycerides). 2-Heptadecenyl-4-methyl-4-hydroxymethyl-2- Hydrogen (hydrogenated compounds). oxazoline. Hydrogen (amines). Hexylene glycol (2-methyl-2-4-pentanediol). Isobutanol (esters). 12-Hydroxystearic acid. Isopropanol (esters). Isobutanol. Magnesium hydroxide (soaps). Isopropanol. Methanol (esters). Isopropylamine salt of dodecylbenzene sul- Morpholine (soaps). fonic acid. Oxygen (air-blown oils). Pentaerythritol (esters). Kerosine. Polyoxyethylene, molecular weights 200, 300, Lanolin. 400, 600, 700, 1,000, 1,540, 1,580, 1,760, 4,600 Methanol. (esters). Methyl 12-hydroxystearate. Polyoxypropylene, molecular weight 200– Methyl taurine-oleic acid condensate, molec- 2,000 (esters). ular weight 486. ′ Potassium hydroxide (soaps). a,a -[Methylenebis[4-(1,1,3,3-tetramethylbu- Propanol (esters). tyl)-o-phenylene]]bis[omega-hydroxypoly Propylene glycol (esters). (oxyethylene)] having 6–7.5 moles of ethyl- Propylene oxide (esters). ene oxide per hydroxyl group. Sodium hydroxide (soaps). Mineral oil. Sorbitol (esters). Mono-, di-, and triisopropanolamine. Sulfuric acid (sulfated and sulfonated com- Mono- and diisopropanolamine stearate. pounds). Monobutyl ether of ethylene glycol. Triethanolamine (amides and soaps). Monoethanolamine. Triisopropanolamine (amides and soaps). Morpholine. Trimethylolethane (esters). Myristyl alcohol. Zinc hydroxide (soaps). Naphtha. β-Naphthol. (3) Miscellaneous: Nonylphenol. Alcohols and ketone alcohols mixture (still- Odorless light petroleum hydrocarbons. Oleyl alcohol. bottom product from C12–C18 alcohol manu- facturing process). Petrolatum. Amyl alcohol. o-Phenylphenol. Butoxy polyethylene polypropylene glycol Pine oil. molecular weight 900–4,200. Polybutene, hydrogenated; complying with Butoxy-polyoxypropylene molecular weight the identity prescribed under § 178.3740(b) of 1,000–2,500. this chapter. Butylated hydroxyanisole. Polyethylene. Butylated hydroxytoluene. Polyethylene, oxidized (air-blown). Calcium lignin sulfonate. Polymer derived from N-vinyl pyrrolidone Capryl alcohol. and copolymers derived from the mixed p-Chlorometacresol. alkyl (C12-C15, C16, C18, C20, and C22) meth- Cyclohexanol. acrylate esters, butyl methacrylate (CAS Diacetyltartaric acid ester of tallow mono- Reg. No. 97–88–1), isobutyl methacrylate glyceride. (CAS Reg. No. 97–86–9) and methyl meth- 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. acrylate (CAS Reg. No. 80–62–6); the com- 35691–65–7), for use as a preservative at a bined polymer contains no more than 5 level not to exceed 0.05 weight-percent of weight percent of polymer units derived the defoaming agent. from N-vinyl pyrrolidone and is present at Diethanolamine. a level not to exceed 7 parts per million by Diethylene triamine. weight of the finished dry paper and paper- Di-(2-ethylhexyl) phthalate. board fibers. 2,6-Dimethyl heptanol-4 (nonyl alcohol). Polyoxyethylene (4 mols) decyl phosphate. Dimethylpolysiloxane. Polyoxyethylene (4 mols) di(2-ethyl hexano- Di-tert-butyl hydroquinone. ate). Dodecylbenzene sulfonic acids. Polyoxyethylene (15 mols) ester of rosin. Ethanol. Polyoxyethylene (3–15 mols) tridecyl alcohol.
214
VerDate 06
Polyoxypropylene, molecular weight 200– accordance with the following pre- 2,000. scribed conditions: Polyoxypropylene-polyoxethylene conden- (a) It is used as follows: sate, minimum molecular weight 950. (1) In the manufacture of paper and Polyoxypropylene-ethylene oxide condensate of ethylene diamine, molecular weight paperboard as a preservative for sub- 1,700–3,800. stances added to the pulp suspension Polyvinyl pyrrolidone, molecular weight prior to the sheet-forming operation 40,000. provided that the preservative is vola- Potassium distearyl phosphate. tilized by heat in the drying and fin- Potassium pentachlorophenate. ishing of the paper and paperboard. Potassium trichlorophenate. (2) As a preservative for coatings for Rosins and rosin derivatives identified in § 175.105(c)(5) of this chapter. paper and paperboard, Provided, That Silica. the preservative is volatilized by heat Siloxanes and silicones, dimethyl, methylhy- in the drying and finishing of the coat- drogen, reaction products with poly- ed paper or paperboard. ethylene-polypropylene glycol monoallyl (b) The quantity used shall not ex- ether (CAS Reg. No. 71965–38–3). ceed the least amount reasonably re- Sodium alkyl (C9–C15) benzene-sulfonate. quired to accomplish the intended Sodium dioctyl sulfosuccinate. technical effect and shall not be in- Sodium distearyl phosphate. Sodium lauryl sulfate. tended to nor, in fact, accomplish any Sodium lignin sulfonate. physical or technical effect in the food Sodium 2-mercaptobenzothiazole. itself. Sodium naphthalenesulfonic acid (3 mols) (c) The use of a preservative in any condensed with formaldehyde (2 mols). substance or article subject to any reg- Sodium orthophenylphenate. ulation in parts 174, 175, 176, 177, 178 Sodium pentachlorophenate. and § 179.45 of this chapter must comply Sodium petroleum sulfonate, molecular with any specifications and limitations weight 440–450. Sodium trichlorophenate. prescribed by such regulation for the Stearyl alcohol. substance or article. α-[p-(1,1,3,3-Tetramethylbutyl) phenyl-, p- nonylphenyl-, or p-dodecylphenyl]-omega- § 176.250 Poly-1,4,7,10,13-pentaaza-15- hydroxypoly(oxyethylene) produced by the hydroxyhexadecane. condensation of 1 mole of p-alkylphenol Poly-1,4,7,10,13-pentaaza-15-hydrox- (alkyl group is 1,1,3,3-tetramethylbutyl, a yhexadecane may be safely used as a propylene trimer isomer, or a propylene retention aid employed prior to the tetramer isomer) with an average of 1.5–15 sheet-forming operation in the manu- moles of ethylene oxide. Tetrahydrofurfuryl alcohol. facture of paper and paperboard in- Tributoxyethyl phosphate. tended for use in contact with food in Tributyl phosphate. an amount not to exceed that nec- Tridecyl alcohol. essary to accomplish the intended Triethanolamine. physical or technical effect and not to Triethylene glycol di(2-ethyl hexanoate). exceed 6 pounds per ton of finished Tri-(2-ethylhexyl) phosphate. paper or paperboard. Tristearyl phosphate. Wax, petroleum, Type I and Type II. § 176.260 Pulp from reclaimed fiber. Wax, petroleum (oxidized). Wax (montan). (a) Pulp from reclaimed fiber may be safely used as a component of articles [42 FR 14554, Mar. 15, 1977, as amended at 47 FR 17986, Apr. 27, 1982; 47 FR 46495, Oct. 19, used in producing, manufacturing, 1982; 47 FR 56845, Dec. 21, 1982; 54 FR 24897, packing, processing, preparing, treat- June 12, 1989; 57 FR 31313, July 15, 1992; 61 FR ing, packaging, transporting, or hold- 14246, Apr. 1, 1996] ing food, subject to the provisions of paragraph (b) of this section. § 176.230 3,5-Dimethyl-1,3,5,2H- (b) Pulp from reclaimed fiber is pre- tetrahydrothiadiazine-2-thione. pared from the paper and paperboard 3,5-Dimethyl-1,3,5,2H-tetrahydrothi- products described in paragraphs (b) (1) adiazine-2-thione may safely be used as and (2) of this section, by repulping a preservative in the manufacture and with water to recover the fiber with coating of paper and paperboard in- the least possible amount of nonfibrous tended for use in contact with food in substances.
215
VerDate 06
(1) Industrial waste from the manu- (1) Slimicides are used as anti- facture of paper and paperboard prod- microbial agents to control slime in ucts excluding that which bears or con- the manufacture of paper and paper- tains any poisonous or deleterious sub- board. stance which is retained in the recov- (2) Subject to any prescribed limita- ered pulp and that migrates to the tions, slimicides are prepared from one food, except as provided in regulations or more of the slime-control substances promulgated under sections 406 and 409 named in paragraph (c) of this section of the Federal Food, Drug, and Cos- to which may be added optional adju- metic Act. (2) Salvage from used paper and pa- vant substances as provided for under perboard excluding that which (i) bears paragraph (d) of this section. or contains any poisonous or delete- (3) Slimicides are added to the proc- rious substance which is retained in ess water used in the production of the recovered pulp and that migrates paper or paperboard, and the quantity to the food, except as provided in regu- added shall not exceed the amount nec- lations promulgated under sections 406 essary to accomplish the intended and 409 of the act or (ii) has been used technical effect. for shipping or handling any such sub- (b) To insure safe usage, the label or stance. labeling of slimicides shall bear ade- quate directions for use. § 176.300 Slimicides. (c) Slime-control substances per- (a) Slimicides may be safely used in mitted for use in the preparation of the manufacture of paper and paper- slimicides include substances subject board that contact food, in accordance to prior sanction or approval for such with the following prescribed condi- use and the following: tions:
List of substances Limitations
Acrolein. Alkenyl (C16±C18) dimethylethyl-ammonium bromide. n-Alkyl (C12±C18) dimethyl benzyl ammonium chloride. 1,2-Benzisothiazolin-3-one ...... At a level of 0.06 pound per ton of dry weight fiber. Bis(1,4-bromoacetoxy)-2-butene. 5,5-Bis(bromoacetoxymethyl) m-dioxane. 2,6-Bis(dimethylaminomethyl) cyclohexanone. 1,2-Bis(monobromoacetoxy) ethane [CA Reg. No. 3785±34±0] At a maximum level of 0.10 pound per ton of dry weight fiber. Bis(trichloromethyl)sulfone. 4-Bromoacetoxymethyl-m-dioxolane. 2-Bromo-4′-hydroxyacetophenone. 2-Bromo-2-nitropropane-1,3-diol (CAS Reg. No. 52±51±7) ...... At a maximum level of 0.6 pound per ton of dry weight fiber. 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 (C12±C18) benzylmethylammonium chloride. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691±65±7) .. At a maximum level of 0.005% of dry weight fiber. 2,2-Dibromo-3-nitrilopropionamide ...... At a maximum level of 0.1 lb/ton of dry weight fiber. 2,3-Dibromopropionaldehyde. 3,5-Dimethyl 1,3,5,2H-tetrahydrothiadiazine-2-thione. Dipotassium and disodium ethylenebis(dithiocarba-mate). Disodium cyanodithioimidocarbonate. n-Dodecylguanidine hydrochloride ...... At a maximum level of 0.20 pound per ton of dry weight fiber. Glutaraldehyde (CAS Reg. No. 111-30-8). 2-(p-hydroxyphenyl) glyoxylohydroximoyl chloride (CAS Reg- At a level of 0.02 pound per ton of dry weight fiber. istry No. 34911±46±1). 2-Hydroxypropyl methanethiol sulfonate. 2-Mercaptobenzothiazole. Methylenebisbutanethiolsulfonate. Methylenebisthiocyanate. 2-Nitrobutyl bromoacetate [CA Reg. No. 32815±96±6] ...... At a maximum level of 0.15 pound per ton of dry weight fiber. N-[α-(Nitroethyl)benzyl] ethylenediamine. Potassium 2-mercaptobenzothiazole. Potassium N-hydroxymethyl-N-methyldithiocarba-mate.
216
VerDate 06
List of substances Limitations
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. 2-(Thiocyanomethylthio) benzothiazole. Vinylene bisthiocyanate.
(d) Adjuvant substances permitted to facturing, packing, processing, pre- be used in the preparation of slimicides paring, treating, packaging, trans- include substances generally recog- porting, or holding food, subject to the nized as safe for use in food, substances provisions of this section. generally recognized as safe for use in (a) Sodium nitrate-urea complex is a paper and paperboard, substances per- clathrate of approximately two parts mitted to be used in paper and paper- urea and one part sodium nitrate. board by other regulations in this (b) Sodium nitrate-urea complex con- chapter, and the following: forming to the limitations prescribed Acetone. in paragraph (b)(1) of this section is Butlylene oxide. used as provided in paragraph (b)(2) of Dibutyl phthalate. this section. Didecyl phthalate. (1) Limitations. (i) It is used as a plas- N,N-Dimethylformamide. ticizer in glassine and greaseproof Dodecyl phthalate. paper. Ethanolamine. Ethylene glycol. (ii) The amount used does not exceed Ethylenediamine. that required to accomplish its in- N-methyl-2-pyrrolidone (CAS Reg. No. 872– tended technical effect or exceed 15 50–4). percent by weight of the finished paper. a,a′-[Methylenebis[4-(1,1,3,3-tetramethyl- (2) Conditions of use. The glassine and butyl)-o-phenylene]] bis[omega-hydroxypoly greaseproof papers are used for pack- (oxyethylene)] having 6–7.5 moles of ethyl- ene oxide per hydroxyl group. aging dry food or as the food-contact Monomethyl ethers of mono-, di-, and tri- surface for dry food. propylene glycol. Nonylphenol reaction product with 9 to 12 § 176.350 Tamarind seed kernel pow- molecules of ethylene oxide. der. Octylphenol reaction product with 25 mol- Tamarind seed kernel powder may be ecules of propylene oxide and 40 molecules of ethylene oxide. safely used as a component of articles intended for use in producing, manu- [42 FR 14554, Mar. 15, 1977, as amended at 42 facturing, packing, processing, pre- FR 41854, Aug. 19, 1977; 44 FR 75627, Dec. 21, paring, treating, packaging, trans- 1979; 46 FR 36129, July 14, 1981; 49 FR 5748, Feb. 15, 1984; 51 FR 19059, May 27, 1986; 51 FR porting, or holding food, subject to the 43734, Dec. 4, 1986; 54 FR 18103, Apr. 27, 1989; provisions of this section. 55 FR 31825, Aug. 6, 1990] (a) Tamarind seed kernel powder is the ground kernel of tamarind seed § 176.320 Sodium nitrate-urea complex. (Tamarindus indica L.) after removal of Sodium nitrate-urea complex may be the seed coat. safely used as a component of articles (b) It is used in the manufacture of intended for use in producing, manu- paper and paperboard.
217
VerDate 06
PART 177—INDIRECT FOOD 177.1570 Poly-1-butene resins and butene/ ethylene copolymers. ADDITIVES: POLYMERS 177.1580 Polycarbonate resins. 177.1585 Polyestercarbonate resins. Subpart A [Reserved] 177.1590 Polyester elastomers. 177.1595 Polyetherimide resin. Subpart B—Substances for Use as Basic 177.1600 Polyethylene resins, carboxyl modi- Components of Single and Repeated fied. Use Food Contact Surfaces 177.1610 Polyethylene, chlorinated. 177.1615 Polyethylene, fluorinated. Sec. 177.1620 Polyethylene, oxidized. 177.1010 Acrylic and modified acrylic plas- 177.1630 Polyethylene phthalate polymers. tics, semirigid and rigid. 177.1632 Poly (phenyleneterephthalamide) 177.1020 Acrylonitrile/butadiene/styrene co– resins. polymer. 177.1635 Poly(p-methylstyrene) and rubber- 177.1030 Acrylonitrile/butadiene/styrene/ modified poly(p-methylstyrene). methyl methacrylate copolymer. 177.1637 Poly(oxy-1,2- 177.1040 Acrylonitrile/styrene copolymer. ethanediyloxycarbonyl-2,6- 177.1050 Acrylonitrile/styrene copolymer naphthalenediylcarbonyl) resins. modified with butadiene/styrene elas- 177.1640 Polystyrene and rubber-modified tomer. polystyrene. 177.1060 n-Alkylglutarimide/acrylic copoly- 177.1650 Polysulfide polymer-polyepoxy res- mers. ins. 177.1200 Cellophane. 177.1655 Polysulfone resins. 177.1210 Closures with sealing gaskets for 177.1660 Poly (tetramethylene food containers. terephthalate). 177.1240 1,4-Cyclohexylene dimethylene 177.1670 Polyvinyl alcohol film. terephthalate and 1,4-cyclohexylene 177.1680 Polyurethane resins. dimethylene isophthalate copolymer. 177.1810 Styrene block polymers. 177.1820 Styrene-maleic anhydride copoly- 177.1310 Ethylene-acrylic acid copolymers. mers. 177.1312 Ethylene-carbon monoxide copoly- 177.1830 Styrene-methyl methacrylate co- mers. polymers. 177.1315 Ethylene-1,4-cyclohexylene 177.1850 Textryls. dimethylene terephthalate copolymers. 177.1900 Urea-formaldehyde resins in molded 177.1320 Ethylene-ethyl acrylate copoly- articles. mers. 177.1950 Vinyl chloride-ethylene copoly- 177.1330 Ionomeric resins. mers. 177.1340 Ethylene-methyl acrylate copoly- 177.1960 Vinyl chloride-hexene-1 copoly- mer resins. mers. 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. 177.1420 Isobutylene polymers. Repeated Use 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.
218
VerDate 06
177.2450 Polyamide-imide resins. more of the acrylic or methacrylic 177.2460 Poly(2,6-dimethyl-1,4-phenylene) monomers listed in paragraph (a)(1) of oxide resins. this section. 177.2465 Polymethylmethacrylate/poly(tri methoxysilylpropyl) methacrylate co- (1) Homopolymers and copolymers of polymers. the following monomers: 177.2470 Polyoxymethylene copolymer. n-Butyl acrylate. 177.2480 Polyoxymethylene homopolymer. n-Butyl methacrylate. 177.2490 Polyphenylene sulfide resins. Ethyl acrylate. 177.2510 Polyvinylidene fluoride resins. 2-Ethylhexyl acrylate. 177.2550 Reverse osmosis membranes. Ethyl methacrylate. 177.2600 Rubber articles intended for re- Methyl acrylate. peated use. Methyl methacrylate. 177.2710 Styrene-divinylbenzene resins, cross-linked. (2) Copolymers produced by copolym- 177.2800 Textiles and textile fibers. erizing one or more of the monomers 177.2910 Ultra-filtration membranes. listed in paragraph (a)(1) of this section AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. with one or more of the following monomers: SOURCE: 42 FR 14572, Mar. 15, 1977, unless otherwise noted. Acrylonitrile. EDITORIAL NOTE: Nomenclature changes to Methacrylonitrile. α part 177 appear at 61 FR 14482, Apr. 2, 1996. -Methylstyrene. Styrene. Vinyl chloride. Subpart A [Reserved] Vinylidene chloride. (3) Polymers identified in paragraphs Subpart B—Substances for Use as (a)(1) and (2) of this section containing Basic Components of Single no more than 5 weight-percent of total and Repeated Use Food Con- polymer units derived by copolym- tact Surfaces erization with one or more of the monomers listed in paragraph (a)(3)(i) § 177.1010 Acrylic and modified acrylic and (ii) of this section. Monomers list- plastics, semirigid and rigid. ed in paragraph (a)(3)(ii) of this section Semirigid and rigid acrylic and modi- are limited to use only in plastic arti- fied acrylic plastics may be safely used cles intended for repeated use in con- as articles intended for use in contact tact with food. 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. semirigid and rigid acrylic and modi- Itaconic acid. 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 weight-percent of the polymer content Service Registry No. 96–05–9] 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.
219
VerDate 06
Dimethylaminoethyl methacrylate. and oils, and fatty alcohols derived 2-Ethylhexyl methacrylate. from such acids. Hydroxyethyl methacrylate. (7) Surface active agent: Sodium Hydroxyethyl vinyl sulfide. Hydroxypropyl methacrylate. dodecylbenzenesulfonate. Isobornyl methacrylate. (8) Miscellaneous materials: Isobutyl methacrylate. Di(2-ethylhexyl) phthalate, for use only as a Isopropyl acrylate. flow promoter at a level not to exceed 3 Isopropyl methacrylate. weight-percent based on the monomers. Methacrylamide. Dimethyl phthalate. Methacrylamidoethylene urea. Oxalic acid, for use only as a polymerization Methacryloxyacetamidoethylethylene urea. catalyst aid. Methacryloxyacetic acid. Tetraethylenepentamine, for use only as a n-Propyl methacrylate. catalyst activator at a level not to exceed 3,5,5-Trimethylcyclohexyl methacrylate. 0.5 weight-percent based on the monomers. (4) Polymers identified in paragraphs Toluene. (a)(1), (2), and (3) of this section are Xylene. mixed together and/or with the fol- (b) The semirigid and rigid acrylic lowing polymers, provided that no and modified acrylic plastics, in the chemical reactions, other than addi- finished form in which they are to con- tion reactions, occur when they are tact food, when extracted with the sol- mixed: vent or solvents characterizing the type of food and under the conditions Butadiene-acrylonitrile copolymers. Butadiene-acrylonitrile-styrene copolymers. of time and temperature as determined Butadiene-acrylonitrile-styrene-methyl from tables 1 and 2 of § 176.170(c) of this methacrylic copolymers. chapter, shall yield extractives not to Butadiene-styrene copolymers. exceed the following, when tested by Butyl rubber. the methods prescribed in paragraph Natural rubber. (c) of this section. The acrylic and Polybutadiene. modified acrylic polymers or plastics Poly (3-chloro-1,3-butadiene). Polyester identified in § 175.300(b)(3)(vii) of intended to be used as components of this chapter. articles also shall yield extractives not Polyvinyl chloride. to exceed the following limitations Vinyl chloride copolymers complying with when prepared as strips as described in § 177.1980. paragraph (c)(2) of this section: Vinyl chloride-vinyl acetate copolymers. (1) Total nonvolatile extractives not (5) Antioxidants and stabilizers iden- to exceed 0.3 milligram per square inch tified in § 175.300(b)(3)(xxx) of this chap- of surface tested. ter and the following: (2) Potassium permanganate oxidiz- able distilled water and 8 and 50 per- Di-tert-butyl-p-cresol. cent alcohol extractives not to exceed 2-Hydroxy-4-methoxybenzophenone. an absorbance of 0.15. 2-Hydroxy-4-methoxy-2- carboxybenzophenone. (3) Ultraviolet-absorbing distilled 3-Hydroxyphenyl benzoate. water and 8 and 50 percent alcohol ex- p-Methoxyphenol. tractives not to exceed an absorbance Methyl salicylate. of 0.30. Octadecyl 3,5-di-tert-butyl-4-hydroxyhydro- (4) Ultraviolet-absorbing n-heptane cinnamate (CAS Reg. No. 2082–79–3): For extractives not to exceed an absorb- use only: (1) At levels not exceeding 0.2 ance of 0.10. percent by weight in semirigid and rigid (c) Analytical methods—(1) Selection of acrylic and modified acrylic plastics, where the finished articles contact foods extractability conditions. These are to be containing not more than 15 percent alco- chosen as provided in § 176.170(c) of this hol; and (2) at levels not exceeding 0.01 per- chapter. cent by weight in semirigid and rigid (2) Preparation of samples. Sufficient acrylic and modified acrylic plastics in- samples to allow duplicates of all ap- tended for repeated food-contact use where plicable tests shall be cut from the ar- the finished article may be used for foods ticles or formed from the plastic com- containing more than 15 percent alcohol. position under tests, as strips about 2.5 Phenyl salicylate. inches by about 0.85-inch wide by about (6) Release agents: Fatty acids de- 0.125-inch thick. The total exposed sur- rived from animal and vegetable fats face should be 5 square inches ±0.5-
220
VerDate 06
square inch. The samples, after prepa- ured versus distilled water in the ref- ration, shall be washed with a clean erence cell shall not exceed 0.15 at 245, brush under hot tapwater, rinsed under 0.09 at 260, 0.04 at 270, and 0.02 at any running hot tapwater (140 °F min- point in the wavelength region of 280 to imum), rinsed with distilled water, and 310 mµ. air-dried in a dust-free area or in a des- (iii) Duplicate ultraviolet blank de- iccator. terminations shall be run on samples of (3) Preparation of solvents. The water each solvent that has been exposed to used shall be double-distilled water, the temperature-time conditions of the prepared in a still using a block tin extraction test without the plastic condenser. The 8 and 50 percent (by vol- sample. An aliquot of the exposed sol- ume) alcohol solvents shall be prepared vent shall be measured versus the un- from ethyl alcohol meeting the speci- exposed solvent in the reference cell. fications of the United States Pharma- The average difference in the copeia XX and diluted with double-dis- absorbances at any wavelength in the tilled water that has been prepared in a region of 245 to 310 mµ shall be used as still using a tin block condenser. The a blank correction for the ultraviolet n-heptane shall be spectrophotometric absorbers measured at the same wave- grade. Adequate precautions must be length according to paragraph (c)(8)(ii) taken to keep all solvents dust-free. of this section. (4) Blank values on solvents. (i) Dupli- (iv) The acceptability of the solvents cate determinations of residual solids for use in the permanganate test shall shall be run on samples of each solvent be determined by preparing duplicate that have been exposed to the tempera- permanganate test blanks according to ture-time conditions of the extraction paragraph (c)(7)(iv) of this section. For test without the plastic sample. Sixty this test, the directions referring to milliliters of exposed solvent is the sample extract shall be dis- pipetted into a clean, weighed plat- regarded. The blanks shall be scanned inum dish, evaporated to 2–5 milliliters in 5-centimeter silica on a nonsparking, low-temperature hot spectrophotometric cells in the spec- plate and dried in 212 °F oven for 30 trophotometer versus the appropriate minutes. The residue for each solvent solvent as reference. The absorbance in shall be determined by weight and the distilled water in the wavelength re- 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 scribed in paragraph (c)(7)(iv) of this air in the reference cell shall not ex- section, except that the appropriate ex- ceed 0.03 at any point in the wave- posed solvent shall be substituted length region of 245 to 310 mµ. The ab- where the directions call for sample ex- sorbance of the 8 percent alcohol when tract. The average difference in the measured versus distilled water in the absorbances in the region of 544 to 552 reference cell shall not exceed 0.01 at mµ shall be used as a blank correction any point in the wavelength region of for the determination of permanganate 245 to 310 mµ. The absorbance of the 50 oxidizable extractives according to percent alcohol when measured versus paragraph (c)(7)(iv) of this section. distilled water in the reference cell (5) Extraction procedure. For each ex- shall not exceed 0.05 at any point in the traction, place a plastic sample in a wavelength region of 245 to 310 mµ. The clean 25 millimeters × 200 millimeters absorbance of the heptane when meas- hard-glass test tube and add solvent
221
VerDate 06
equal to 10 milliliters of solvent per s=Total surface of the plastic sample in square inch of plastic surface. This square inches. amount will be between 45 milliliters (7) Determination of potassium per- and 55 milliliters. The solvent must be manganate oxidizable extractives. (i) Pi- preequilibrated to the temperature of pette 25 milliliters of distilled water the extraction test. Close the test tube with a ground-glass stopper and expose into a clean 125-milliliter Erlenmeyer to the specified temperature for the flask that has been rinsed several specified time. Cool the tube and con- times with aliquots of distilled water. tents to room temperature if nec- This is the blank. Prepare a distilled essary. water solution containing 1.0 part per (6) Determination of total nonvolatile million of p-methoxyphenol (melting extractives. Remove the plastic strip point 54–56 °C, Eastman grade or equiv- from the solvent with a pair of clean alent). Pipette 25 milliliters of this p- forceps and wash the strip with 5 milli- methoxyphenol solution into a rinsed liters of the appropriate solvent, add- Erlenmeyer flask. Pipette exactly 3.0 ing the washings to the contents of the milliliters of 154 parts per million test tube. Pour the contents of the test aqueous potassium permanganate solu- tube into a clean, weighed platinum tion into the p-methoxyphenol and ex- dish. Wash the tube with 5 milliliters actly 3.0 milliliters into the blank, in of the appropriate solvent and add the that order. Swirl both flasks to mix the solvent to the platinum dish. Evapo- contents and then transfer aliquots rate the solvent to 2–5 milliliters on a from each flask into matched 5-centi- nonsparking, low-temperature meter spectrophotometric absorption hotplate. Complete the evaporation in cells. The cells are placed in the spec- a 212 °F oven for 30 minutes. Cool the trophotometer cell compartment with dish in a desiccator for 30 minutes and the p-methoxyphenol solution in the weigh to the nearest 0.1 milligram. Cal- culate the total nonvolatile extractives reference beam. Spectrophotometric as follows: measurement is conducted as in para- graph (c)(7)(iv) of this section. The ab- e− b sorbance reading in the region 544–552 Milligrams extractives = µ per square inch m should be 0.24 but must be not less s than 0.12 nor more than 0.36. This test shall be run in duplicate. For the pur- Extractives in parts eb = ×100 pose of ascertaining compliance with per million the limitations in paragraph (b)(2) of s this section, the absorbance measure- where: ments obtained on the distilled water e=Total increase in weight of the dish, in extracts according to paragraph milligrams. b=Blank value of the solvent in milligrams, (c)(7)(iv) of this section shall be multi- as determined in paragraph (c)(4)(i) of plied by a correction factor, calculated this section. as follows:
0. 24 = 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 more than 0.39. This test shall be run in (c)(7)(i) of this section is repeated ex- duplicate. For the purpose of cept that, in this instance, the solvent ascertaining compliance with the limi- shall be 8 percent alcohol. The absorb- tations prescribed in paragraph (b)(2) of ance in the region 544–552 mµ should be 0.26 but must be not less than 0.13 nor
222
VerDate 06
this section, the absorbance measure- (c)(7)(iv) of this section shall be multi- ments obtained on the 8 percent alco- plied by a correction factor, calculated hol extracts according to paragraph as follows:
0. 26 = Correction factor for aqueous Average of duplicate ρ -methoxyphenol 8 percent alcohol extracts. absorbance determination according to this paragraph (c)(7)(ii) of this section
(iii) The procedure in paragraph ascertaining compliance with the limi- (c)(7)(i) of this section is repeated ex- tations prescribed in paragraph (b)(2) of cept that, in this instance, the solvent this section, the absorbance measure- shall be 50 percent alcohol. The absorb- ments obtained on the 50 percent alco- ance in the region 544–552 mµ should be hol extracts according to paragraph 0.25 but must be not less than 0.12 nor (c)(7)(iv) of this section shall be multi- more than 0.38. This test shall be run in plied by a correction factor, calculated duplicate. For the purpose of as follows:
0. 25 = 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 sorbance scale from 700 mµ to 500 mµ in extracts. Pipette 25 milliliters of the ap- such a way that the region 544 mµ to propriate solvent into a clean, 125-mil- 552 mµ is scanned within 5 minutes to liliter Erlenmeyer flask that has been 10 minutes of the time that permanga- rinsed several times with aliquots of nate was added to the solutions. The the same solvent. This is the blank. height of the absorbance peak shall be Into another similarly rinsed flask, pi- measured, corrected for the blank as pette 25 milliliters of the sample ex- determined in paragraph (c)(4)(v) of tract that has been exposed under the this section, and multiplied by the ap- conditions specified in paragraph (c)(5) propriate correction factor determined of this section. Pipette exactly 3.0 mil- according to paragraph (c)(7) (i), (ii), liliters of 154 parts per million aqueous and (iii) of this section. This test shall potassium permanganate solution into be run in duplicate and the two results the sample and exactly 3.0 milliliters averaged. into the blank, in that order. Before (8) Determination of ultraviolet-absorb- use, the potassium permanganate solu- ing extractives. (i) A distilled water so- tion shall be checked as in paragraph lution containing 1.0 part per million (c)(7)(i) of this section. Both flasks are of p-methoxyphenol (melting point 54 swirled to mix the contents, and then °C–56 °C. Eastman grade or equivalent) aliquots from each flask are trans- shall be scanned in the region 360 to 220 ferred to matched 5-centimeter mµ in 5-centimeter silica spectrophoto- spectrophotometric absorption cells. metric absorption cells versus a dis- Both cells are placed in the spectro- tilled water reference. The absorbance photometer cell compartment with the at the wavelength of maximum absorb- sample solution in the reference beam. ance (should be about 285 mµ) is about The spectrophotometer is adjusted for 0.11 but must be not less than 0.08 nor 0 and 100 percent transmittance at 700 more than 0.14. This test shall be run in mµ. The spectrum is scanned on the ab- duplicate. For the purpose of
223
VerDate 06
ascertaining compliance with the limi- paragraph (c)(8)(ii) of this section shall tations prescribed in paragraph (b) (3) be multiplied by a correction factor, and (4) of this section, the absorbance calculated as follows: obtained on the extracts according to
0. 11 = Correction factor for ultraviolet Average of duplicate ρ -methoxyphenol absorbers test. absorbance determinations according to this paragraph (c)(8)(i) of this section
(ii) An aliquot of the extract that has the article in the finished form in been exposed under the conditions which it is to contact food. specified in paragraph (c)(5) of this sec- [42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. tion is scanned in the wavelength re- 28, 1977, as amended at 43 FR 54927, Nov. 24, gion 360 to 220 mµ versus the appro- 1978; 45 FR 67320, Oct. 10, 1980; 46 FR 46796, priate solvent reference in matched 5- Sept. 22, 1981; 49 FR 10108, Mar. 19, 1984; 49 FR centimeter silica spectrophotometric 13139, Apr. 3, 1984; 50 FR 31045, July 24, 1985] absorption cells. The height of any ab- § 177.1020 Acrylonitrile/butadiene/sty- sorption peak shall be measured, cor- rene co-polymer. rected for the blank as determined in paragraph (c)(4)(iii) of this section, and Acrylonitrile/butadiene/styrene co- multiplied by the correction factor de- polymer identified in this section may be safely used as an article or compo- termined according to paragraph nent of articles intended for use with (c)(8)(i) of this section. all foods, except those containing alco- (d) In accordance with current good hol, under conditions of use E, F, and G manufacturing practice, finished described in table 2 of § 176.170(c) of this semirigid and rigid acrylic and modi- chapter. fied acrylic plastics, and articles con- (a) Identity. For the purpose of this taining these polymers, intended for section, the acrylonitrile/butadiene/ repeated use in contact with food shall styrene copolymer consists of: be thoroughly cleansed prior to their (1) Eighty-four to eighty-nine parts first use in contact with food. by weight of a matrix polymer con- (e) Acrylonitrile copolymers identi- taining 73 to 78 parts by weight of acry- fied in this section shall comply with lonitrile and 22 to 27 parts by weight of the provisions of § 180.22 of this chap- styrene; and ter. (2) Eleven to sixteen parts by weight (f) The acrylic and modified acrylic of a grafted rubber consisting of (i) 8 to polymers identified in and complying 13 parts of butadiene/styrene elastomer with this section, when used as compo- containing 72 to 77 parts by weight of nents of the food-contact surface of an butadiene and 23 to 28 parts by weight article that is the subject of a regula- of styrene and (ii) 3 to 8 parts by tion in this part and in parts 174, 175, weight of a graft polymer having the same composition range as the matrix 176, and 178 of this chapter, shall com- polymer. ply with any specifications and limita- (b) Adjuvants. The copolymer identi- tions prescribed by such regulation for fied in paragraph (a) of this section
224
VerDate 06
may contain adjuvant substances re- water and 3 percent acetic acid at 150 quired in its production. Such adju- °F for 15 days when analyzed by a po- vants may include substances gen- larographic method titled ‘‘Extracted erally recognized as safe in food, sub- Acrylonitrile by Differential Pulse Po- stances used in accordance with prior larography,’’ which is incorporated by sanction, substances permitted in this reference. Copies are available from part, and the following: the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Substance Limitations Administration, 200 C St. SW., Wash- 2-Mercapto- ethanol ...... The finished copolymer shall ington, DC 20204, or available for in- contain not more than 100 spection at the Office of the Federal ppm 2-mercaptoethanol ac- Register, 800 North Capitol Street, rylonitrile adduct as deter- mined by a method titled NW., suite 700, Washington, DC 20408. ``Analysis of Cycopac (e) Acrylonitrile copolymers identi- Resin for Residual β-(2- fied in this section shall comply with Hydroxyethylmercapto) pro- pionitrile,'' which is incor- the provisions of § 180.22 of this chap- porated by reference. Cop- ter. ies are available from the (f) Acrylonitrile copolymers identi- Bureau of Foods (HFS± 200), Food and Drug Ad- fied in this section are not authorized ministration, 200 C St. to be used to fabricate beverage con- SW., Washington, DC tainers. 20204, or available for in- spection at the Office of [42 FR 14572, Mar. 15, 1977, as amended at 42 the Federal Register, 800 FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, North Capitol Street, NW., suite 700, Washington, DC 1982; 54 FR 24897, June 12, 1989] 20408. § 177.1030 Acrylonitrile/butadiene/sty- (c) Specifications. (1) Nitrogen content rene/methyl methacrylate copoly- of the copolymer is in the range of 16 mer. to 18.5 percent as determined by Micro- Acrylonitrile/butadiene/styrene/ Kjeldahl analysis. methyl methacrylate copolymer iden- (2) Residual acrylonitrile monomer tified in this section may be safely content of the finished copolymer arti- used as an article or component of arti- cles is not more than 11 parts per mil- cles intended for use with food identi- lion as determined by a gas fied in table 1 of § 176.170(c) of this chromatographic method titled ‘‘De- chapter as Type I, II, III, IVA, IVB, V, termination of Residual Acrylonitrile VIB, (except bottles intended to hold and Styrene Monomers-Gas carbonated beverages), VIIA, VIIB, VIII Chromatographic Internal Standard and IX, under conditions of use C, D, E, Method,’’ which is incorporated by ref- F, and G described in table 2 of erence. Copies are available from the § 176.170(c) of this chapter with a high Center for Food Safety and Applied Nu- temperature limitation of 190 °F. trition (HFS–200), Food and Drug Ad- (a) Identity. For the purpose of this ministration, 200 C St. SW., Wash- section, acrylonitrile/butadiene/sty- ington, DC 20204, or available for in- rene/methyl methacrylate copolymer spection at the Office of the Federal consists of: (1) 73 to 79 parts by weight Register, 800 North Capitol Street, of a matrix polymer containing 64 to 69 NW., suite 700, Washington, DC 20408. parts by weight of acrylonitrile, 25 to (d) Extractive limitations. (1) Total 30 parts by weight of styrene and 4 to nonvolatile extractives not to exceed 6 parts by weight of methyl methacry- 0.0005 milligram per square inch sur- late; and (2) 21 to 27 parts by weight of face area when the finished food con- a grafted rubber consisting of (i) 16 to tact article is exposed to distilled 20 parts of butadiene/styrene/elastomer water, 3 percent acetic acid, or n- containing 72 to 77 parts by weight of heptane for 8 days at 120 °F. butadiene and 23 to 28 parts by weight (2) The finished food-contact article of styrene and (ii) 5 to 10 parts by shall yield not more than 0.0015 milli- weight of a graft polymer having the gram per square inch of acrylonitrile same composition range as the matrix monomer when exposed to distilled polymer.
225
VerDate 06
(b) Adjuvants. The copolymer identi- (2) The finished food-contact article fied in paragraph (a) of this section shall yield not more than 0.0025 milli- may contain adjuvant substances re- gram per square inch of acrylonitrile quired in its production. Such adju- monomer when exposed to distilled vants may include substances gen- water, 3 percent acetic acid and n- erally recognized as safe in food, sub- heptane at 190 °F for 2 hours, cooled to stances used in accordance with prior 120 °F (80 to 90 minutes) and main- sanction, substances permitted under tained at 120 °F for 10 days when ana- applicable regulations in this part, and lyzed by a polarographic method titled the following: ‘‘Extracted Acrylonitrile by Differen- tial Pulse Polarography,’’ which is in- Substances Limitations corporated by reference. Copies are available from the Center for Food 2±Mercaptoethanol ...... The finished copolymer shall Safety and Applied Nutrition (HFS– contain not more than 800 ppm 2±mercaptoethanol 200), Food and Drug Administration, acrylonitrile adduct as de- 200 C St. SW., Washington, DC 20204, or termined by a method titled available for inspection at the Office of ``Analysis of Cycopac Resin for Residual β±(2± the Federal Register, 800 North Capitol Hydroxyethylmercapto) pro- Street, NW., suite 700, Washington, DC pionitrile,'' which is incor- 20408. porated by reference. Cop- (e) Acrylonitrile copolymers identi- ies are available from the Bureau of Foods (HFS± fied in this section shall comply with 200), Food and Drug Ad- the provisions of § 180.22 of this chap- ministration, 200 C St. ter. SW., Washington, DC 20204, or available for in- (f) Acrylonitrile copolymers identi- spection at the Office of fied in this section are not authorized the Federal Register, 800 to be used to fabricate beverage con- North Capitol Street, NW., tainers. suite 700, Washington, DC 20408. [42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, (c) Specifications. (1) Nitrogen content 1982; 54 FR 24898, June 12, 1989] of the copolymer is in the range of 13.0 to 16.0 percent as determined by Micro- § 177.1040 Acrylonitrile/styrene copoly- Kjeldahl analysis. mer. (2) Residual acrylonitrile monomer Acrylonitrile/styrene copolymers content of the finished copolymer arti- identified in this section may be safely cles is not more than 11 parts per mil- used as a component of packaging ma- lion as determined by a gas terials subject to the provisions of this chromatographic method titled ‘‘De- section. termination of Residual Acrylonitrile (a) Identity. For the purposes of this section acrylonitrile/styrene copoly- and Styrene Monomers-Gas mers are basic copolymers meeting the Chromatographic Internal Standard specifications prescribed in paragraph Method,’’ which is incorporated by ref- (c) of this section. erence. Copies are available from the (b) Adjuvants. (1) The copolymers Center for Food Safety and Applied Nu- identified in paragraph (c) of this sec- trition (HFS–200), Food and Drug Ad- tion may contain adjuvant substances ministration, 200 C St. SW., Wash- required in their production, with the ington, DC 20204, or available for in- exception that they shall not contain spection at the Office of the Federal mercaptans or other substances which Register, 800 North Capitol Street, form reversible complexes with acryl- NW., suite 700, Washington, DC 20408. onitrile monomer. Permissible adju- (d) Extractive limitations. (1) Total vants may include substances gen- nonvolatile extractives not to exceed erally recognized as safe in food, sub- 0.0005 milligram per square inch sur- stances used in accordance with prior face area of the food-contact article sanction, substances permitted under when exposed to distilled water, 3 per- applicable regulations in this part, and cent acetic acid, 50 percent ethanol, those authorized in paragraph (b)(2) of and n-heptane for 10 days at 120 °F. this section.
226
VerDate 06
(2) The optional adjuvants for the ac- Substances Limitation rylonitrile/styrene copolymer identi- Condensation polymer of toluene 0.15 pct maximum. fied in paragraphs (c) (1) and (3) of this sulfonamide and formaldehyde. section are as follows: (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 66± area of the food contact article weight is 30,000.1 72 parts by weight of acrylo- when exposed to distilled water nitrile and 28±34 parts by weight and 3 pct acetic acid for 10 d at of styrene; for use with food of 66 °C (150 °F). Type VI±B identified in table 1 of The extracted copolymer shall not § 176.170(c) of this chapter exceed 0.001 mg/in 2 surface under conditions of use C, D, E, area of the food contact article F, G described in table 2 of when exposed to distilled water § 176.170(c) of this chapter. and 3 pct acetic acid for 10 d at 66 °C (150 °F) 1. 2. Acrylonitrile/styrene copolymer 50 ppm1 ...... 12.2 to 17.2 Extracted copolymer not to exceed Minimum 10 pct solu- consisting of the copolymer pro- pct. 2.0 ppm in aqueous extract or n- tion viscosity at 25 duced by polymerization of 45± heptane extract obtained when °C (77 °F) is 10cP.1 65 parts by weight of acrylo- 100 g sample of the basic co- nitrile and 35±55 parts by weigth polymer in the form of particles of styrene; for use with food of of a size that will pass through a Types, I, II, III, IV, V, VI (except U.S. Standard Sieve No. 6 and bottles), VII, VIII, and IX identi- that will be held on a U.S. fied in table 1 of § 176.170(c) of Standard Sieve No. 10 is ex- this chapter under conditions B tracted with 250 mil of deionized (not to exceed 93 °C (200 °F)), water or reagent grade n- C, D, E, F, G described in table heptane at reflux temperature 2 of § 176.170(c) of this chapter. for 2 h.1 3. Acrylonitrile/styrene copolymer 0.10 ppm 17.4 to 19 Total nonvolatile extractives not to Maximum carbon di- consisting of the copolymer pro- (calculated pct. exceed 0.01 mg/in 2 surface oxide permeability duced by polymerization of 66± on the area of the food contact article at 23 °C (73 °F) for 72 parts by weight of acrylo- basis of when exposed to distilled water the finished article nitrile and 28±34 parts by weight the weight and 3 pct acetic acid for 10 d at is 0.04 barrer.3 of styrene; for use with food of of the ac- 66 °C (150 °F). Types VI±A and VI±B identified rylonitrile The extracted copolymer shall not in table 1 of § 176.170(c) of this copolymer exceed 0.001 mg/in 2 surface chapter under conditions of use resin in the area of the food contact article C, D, E, F, G described in table finished ar- when exposed to distilled water 2 of § 176.170(c) of this chapter. ticles).2 and 3 pct acetic acid for 10 d at 66 °C (150 °F).1. 1 Use methods for determination of residual acrylonitrile monomer content, maximum extractable fraction, number average 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 (HFS±200), 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 (HFS±200), 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 D±1434±82, ``Standard Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting,'' which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS±200), 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- (e) Acrylonitrile copolymer identified polymers identified in this section in this section may be used to fabricate shall comply with the provisions of § 180.22 of this chapter.
227
VerDate 06
beverage containers only if they com- Substances Limitations ply with the specifications of item 3 in n-Dodecylmercaptan ...... The finished copolymer shall paragraph (c) of this section. contain not more than 500 parts per million (ppm) [42 FR 14572, Mar. 15, 1977, as amended at 42 dodecylmercaptan as FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, dodecylmercapto- 1982; 49 FR 36643, Sept. 19, 1984; 52 FR 33803, propionitrile as determined Sept. 8, 1987] by the method titled, ``De- termination of β-Dodecyl- mercaptopropionitrile in § 177.1050 Acrylonitrile/styrene copoly- NR±16 Polymer,'' which is mer modified with butadiene/sty- incorporated by reference. rene elastomer. Copies are available from the Center for Food Safety Acrylonitrile/styrene copolymer and Applied Nutrition modified with butadiene/styrene elas- (HFS±200), Food and Drug Administration, 200 C St., tomer identified in this section may be SW., Washington, DC safely used as a component of bottles 20204, or available for in- intended for use with foods identified spection at the Office of the Federal Register, 800 in table I of § 176.170(c) of this chapter North Capitol Street, NW., as Type VI–B under conditions for use suite 700, Washington, DC E, F, or G described in table 2 of 20408. § 176.170(c) of this chapter. (c) Specifications. (1) Nitrogen content (a) For the purpose of this Identity. of the modified copolymer is in the section, acrylonitrile/styrene copoly- range of 17.7–19.8 percent. mer modified with butadiene/styrene (2) Intrinsic viscosity of the matrix elastomer consists of a blend of: copolymer in butyrolactone is not less (1) 82–88 parts by weight of a matrix than 0.5 deciliter/gram at 35 °C, as de- copolymer produced by polymerization termined by the method titled ‘‘Molec- of 77–82 parts by weight of acrylonitrile ular Weight of Matrix Copolymer by and 18–23 parts of styrene; and Solution Viscosity,’’ which is incor- (2) 12–18 parts by weight of a grafted porated by reference. Copies are avail- rubber consisting of (i) 8–12 parts of bu- able from the Center for Food Safety tadiene/styrene elastomer containing and Applied Nutrition (HFS–200), Food 77–82 parts by weight of butadiene and and Drug Administration, 200 C St. 18–23 parts by weight of styrene and (ii) SW., Washington, DC 20204, or available 4–6 parts by weight of a graft copoly- for inspection at the Office of the Fed- mer consisting of 70–77 parts by weight eral Register, 800 North Capitol Street, of acrylonitrile and 23–30 parts by NW., suite 700, Washington, DC 20408. weight of styrene. (3) Residual acrylonitrile monomer content of the modified copolymer ar- (b) Adjuvants. The modified copoly- ticles is not more than 11 ppm as deter- mer identified in paragraph (a) of this mined by a gas chromatographic meth- section may contain adjuvant sub- od titled ‘‘Determination of Residual stances required in its production. Acrylonitrile and Styrene Monomers- Such adjuvants may include substances Gas Chromatographic Internal Stand- generally recognized as safe in food, ard Method,’’ which is incorporated by substances used in accordance with reference. Copies are available from prior sanction, substances permitted the Center for Food Safety and Applied under applicable regulations in this Nutrition (HFS–200), Food and Drug part, and the following: Administration, 200 C St. SW., Wash- ington, DC 20204, or available for in- spection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.
228
VerDate 06
(d) Extractives limitations. The fol- incorporated by reference. Copies, are lowing extractives limitations are de- available from the Center for Food termined by an infrared spectrophoto- Safety and Applied Nutrition (HFS– metric method titled ‘‘Infrared 200), Food and Drug Administration, Spectrophotometric Determination of 200 C St. SW., Washington, DC 20204, or Polymer Extracted from Borex 210 available for inspection at the Office of Resin Pellets,’’ which is incorporated the Federal Register, 800 North Capitol by reference. Copies are available from Street, NW., suite 700, Washington, DC the Center for Food Safety and Applied 20408. Nutrition (HFS–200), Food and Drug (f) Acrylonitrile copolymers identi- Administration, 200 C St. SW., Wash- fied in this section shall comply with ington, DC 20204, or available for in- the provisions of § 180.22 of this chap- spection at the Office of the Federal ter. Register, 800 North Capitol Street, (g) Acrylonitrile copolymers identi- NW., suite 700, Washington, DC 20408, fied in this section are not authorized and are applicable to the modified co- to be used to fabricate beverage con- polymers in the form of particles of a tainers. size that will pass through a U.S. [42 FR 14572, Mar. 15, 1977, as amended at 42 Standard Sieve No. 6 and that will be FR 48544, Sept. 23, 1977; 47 FR 11841, Mar. 19, held on a U.S. Standard Sieve No. 10: 1982; 47 FR 16775, Apr. 20, 1982; 54 FR 24898, (1) The extracted copolymer shall not June 12, 1989] exceed 2.0 ppm in aqueous extract ob- tained when a 100-gram sample of co- § 177.1060 n-Alkylglutarimide/acrylic polymer is extracted with 250 milli- copolymers. liters of freshly distilled water at n-Alkylglutarimide/acrylic copoly- reflux temperature for 2 hours. mers identified in this section may be (2) The extracted copolymer shall not safely used as articles or components exceed 0.5 ppm in n-heptane when a 100- of articles intended for use in contact gram sample of the basic copol-ymer is with food subject to provisions of this extracted with 250 milliliters spectral section and part 174 of this chapter. grade n-heptane at reflux temperature (a) Identity. For the purpose of this for 2 hours. section, n-alkylglutarimide/acrylic co- (e) Accelerated extraction end test. The polymers are copolymers obtained by modified copolymer shall yield acrylo- reaction of substances permitted by nitrile monomer not in excess of 0.4 § 177.1010(a) (1), (2), and (3) with the fol- ppm when tested as follows: lowing substance: Monomethylamine (1) The modified copolymer shall be (CAS Reg. No. 74–89–5), to form n- in the form of eight strips 1⁄2 inch by 4 methylglutarimide/acrylic copolymers. inches by .03 inch. (b) Adjuvants. The copolymers identi- (2) The modified copolymer strips fied in paragraph (a) of this section shall be immersed in 225 milliliters of 3 may contain adjuvant substances re- percent acetic acid in a Pyrex glass quired in their production. The op- pressure bottle. tional adjuvant substances required in (3) The pyrex glass pressure bottle is the production of the basic polymer then sealed and heated to 150 °F in ei- may include substances permitted for ther a circulating air oven or a thermo- such use by applicable regulations, as stat controlled bath for a period of 8 set forth in part 174 of this chapter. days. (c) Specifications. Maximum nitrogen (4) The Pyrex glass pressure bottle is content of the copolymer determined then removed from the oven or bath by micro-Kjeldahl analysis, shall not and cooled to room temperature. A exceed 8 percent. sample of the extracting solvent is (d) Limitations. (1) The n-alkylglutar- then withdrawn and analyzed for acry- imide/acrylic copolymers in the fin- lonitrile monomer by a gas ished form in which they shall contact chromatographic method titled ‘‘Gas- food, when extracted with the solvent Solid Chromatographic Procedure for or solvents characterizing the type of Determining Acrylonitrile Monomer in food and under the conditions of time Acrylonitrile-Containing Polymers and and temperature described in tables 1 Food Simulating Solvents,’’ which is and 2 of § 176.170(c) of this chapter,
229
VerDate 06
shall yield extractives not to exceed (a) Cellophane consists of a base the limitations of § 177.1010(b) of this sheet made from regenerated cellulose chapter, when prepared as strips, as de- to which have been added certain op- scribed in § 177.1010(c)(2) of this chapter. tional substances of a grade of purity (2) The n-alkylglutarimide/acrylic co- suitable for use in food packaging as polymers shall not be used as polymer constituents of the base sheet or as modifiers in vinyl chloride homo- or coatings applied to impart desired copolymers. technological properties. (e) Conditions of use. The n- (b) Subject to any limitations pre- alkylglutarimide/acrylic copolymers scribed in this part, the optional sub- are used as articles or components of stances used in the base sheet and articles (other than articles composed coating may include: of vinyl chloride homo- or copolymers) (1) Substances generally recognized intended for use in contact with all as safe in food. foods except beverages containing (2) Substances for which prior ap- more than 8 percent alcohol under con- proval or sanctions permit their use in ditions of use D, E, F, and G as de- cellophane, under conditions specified scribed in table 2 of § 176.170(c) of this in such sanctions and substances listed chapter. in § 181.22 of this chapter. [54 FR 20382, May 11, 1989, as amended at 58 (3) Substances that by any regulation FR 17098, Apr. 1, 1993] promulgated under section 409 of the act may be safely used as components § 177.1200 Cellophane. of cellophane. Cellophane may be safely used for (4) Substances named in this section packaging food in accordance with the and further identified as required. following prescribed conditions: (c) List of substances:
Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)
Acrylonitrile-butadiene copolymer resins ...... As the basic polymer. Acrylonitrile-butadiene-styrene copolymer resins ...... Do. Acrylonitrile-styrene copolymer resins ...... Do. Acrylonitrile-vinyl chloride copolymer resins ...... Do. N-Acyl sarcosines where the acyl group is lauroyl or stearoyl. .. For use only as release agents in coatings at levels not to 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 (C12±C18) diethanolamide, coconut oil For use only as an adjuvant employed during the processing of fatty acid (C12±C18) diethanolamine soap, and cellulose pulp used in the manufacture of cellophane base diethanolamine mixture having total alkali (calculated as po- sheet. tassium hydroxide) of 16±18% and having an acid number of 25±35. Copal resin, heat processed ...... As basic resin. Damar resin. Defoaming agents identified in § 176.200 of this chapter.
230
VerDate 06
Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)
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 (C8±C18) ammonium chloride ...... 0.005 percent for use only as a flocculant for slip agents. Di-n-ocyltin bis (2-ethylhexyl maleate) ...... For use only as a stabilizer at a level not to exceed 0.55 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°±228 °F., as determined by ASTM method D127±60 (``Standard Method of Test for Melting Point of Petrolatum and Microcrystalline Wax'' (Revised 1960), which is 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. 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.
231
VerDate 06
Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)
α-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1 α- methylstyrene to 3 vinyltoluene). Mineral oil, white. Naphthalenesulfonic acid-formaldehyde condensate, sodium 0.1 percent, for use only as an emulsifier. salt. Nitrocellulose, 10.9 percent±12.2 percent nitrogen. Nylon resins complying with § 177.1500. n-Octyl alcohol ...... For use only as a defoaming agent in the manufacture of 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 2,000±10,200; For use only as an adjuvant in vinylidene chloride copolymer bromine number range 210±320). coatings. Polycarbonate resins complying with § 177.1580. Polyester resin formed by the reaction of the methyl ester of rosin, phthalic anhydride, maleic anhydride, and ethylene glycol, such that the polyester resin has an acid number of 4 to 11, a drop-softening point of 70 °C±92 °C, and a color of K or paler. Polyethylene. Polyethyleneaminostearamide ethyl sulfate produced when ste- 0.1 percent. aric acid is made to react with equal parts of diethylenetriamine and triethylenetetramine and the reaction product is quaternized with diethyl sulfate. Polyethylene glycol (400) monolaurate. Polyethylene glycol (600) monolaurate. Polyethylene glycol (400) monooleate. Polyethylene glycol (600) monooleate. Polyethylene glycol (400) monostearate. Polyethylene glycol (600) monostearate. Polyethylene, oxidized: complying with the identity prescribed in § 177.1620(a). Polyethylenimine ...... As the basic polymer, for use as a resin to anchor coatings to the substrate and for use as an impregnant in the food-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 1,900±9,000). lulose pulp used in the manufacture of cellophane base sheet. Polypropylene complying with § 177.1520. Polystyrene ...... As the basic polymer. Polyvinyl acetate ...... Do. 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.
232
VerDate 06
Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)
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). 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 ing, processing, preparing, treating, this section covered by a specific food packaging, transporting, or holding additive regulation must meet any food in accordance with the following specifications in that regulation. prescribed conditions: (e) Acrylonitrile copolymers identi- (a) Closures for food containers are fied in this section shall comply with manufactured from substances gen- the provisions of § 180.22 of this chap- erally recognized as safe for contact ter. with food; substances that are subject to the provisions of prior sanctions; [42 FR 14572, Mar. 15, 1977, as amended at 47 substances authorized by regulations FR 11842, Mar. 19, 1982] in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter; and closure-sealing § 177.1210 Closures with sealing gas- gaskets, as further prescribed in this kets for food containers. section. Closures with sealing gaskets may be (b) Closure-sealing gaskets and over- safely used on containers intended for all discs are formulated from sub- use in producing, manufacturing, pack- stances identified in § 175.300(b) of this
233
VerDate 06
chapter, with the exception of para- (4) Substances identified in para- graph (b)(3) (v), (xxxi), and (xxxii) of graph (b)(5) of this section, used in that section, and from other optional amounts not to exceed those required substances, including the following: to accomplish the intended physical or (1) Substances generally recognized technical effect and in conformance as safe in food. with any limitation provided; and fur- (2) Substances used in accordance ther provided that any substance em- with the provisions of a prior sanction ployed in the production of closure- sealing gasket compositions that is the or approval within the meaning of sec- subject of a regulation in parts 174, 175, tion 201(s) of the act. 176, 177, 178 and § 179.45 of this chapter (3) Substances that are the subject of conforms with the identity or speci- regulations in parts 174, 175, 176, 177, 178 fications prescribed. and § 179.45 of this chapter and used in (5) Substances that may be employed accordance with the conditions pre- in the manufacture of closure-sealing scribed. gaskets include:
TABLE 1
Limitations (expressed as percent by weight of closure-sealing List of substances gasket composition)
Arachidy-l-behenyl amide (C20±C22fatty acid amides) ...... 5 percent. Azodicarbonamide ...... 1. 2 percent. 2. 5 percent; for use only in the manufacture of polyethylene complying with item 2.1 in § 177.1520(c) of this chapter. Balata rubber. Benzyl alcohol ...... 1 percent. Brominated isobutylene-isoprene copolymers, produced when isobutylene-isoprene copolymers complying with § 177.1420(a)(2) are modified by bromination with not more than 2.3 weight-percent of bromine and having a Mooney Viscosity (ML 1+8 (125 °C)) of 27 or higher. The viscosity is determined by the American Society for Testing and Mate- rials (ASTM) method D 1646±81, ``Standard Test Method for RubberÐViscosity 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 (HFS±200), 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. 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.
234
VerDate 06
TABLE 1ÐContinued
Limitations (expressed as percent by weight of closure-sealing List of substances gasket composition)
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). Ethylene-vinyl acetate copolymer. Glyceryl mono-12-hydroxystearate (hydrogenated glyceryl 2 percent. ricinoleate). Gutta-percha. Hexamethylenetetramine ...... 1 percent. Hexylene glycol ...... 0.5 percent. Isobutylene-isoprene copolymers complying with § 177.1420. Maleic anhydride-polyethylene copolymer ...... 5 percent. Maleic anhydride-styrene copolymer ...... Do. 2,2′-Methylenebis[6-(1-methylcylcohexyl)-p-cresol] ...... 1 percent. Mixed octylated diphenylamine (CAS Reg. No. 68411±46±1) ... 0.1 percent in isobutylene-isoprene and chlorinated isobutylene-isoprene copolymers complying with § 177.1420, and brominated isobutylene-isoprene copolymers complying with this section. Napthalene sulfonic acid-formaldehyde condensate, sodium 0.2 percent. salt. Natural rubber (crepe, latex, mechanical dispersions). 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. 2750±3000. 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.
235
VerDate 06
TABLE 1ÐContinued
Limitations (expressed as percent by weight of closure-sealing List of substances gasket composition)
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. 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 2ÐMAXIMUM 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- form Chloro- tainer with a solvent or solvents char- form fraction form acterizing the type of foods, and under Type of closure-sealing gas- fraction of fraction ket composition of water heptane of alco- conditions of time and temperature extrac- extrac- hol ex- characterizing the conditions of its use tives tives tractives 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 cured natural and syn- not to exceed the tolerances specified 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 melt, solution, plastisol, which the closure is to be used. Employ 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 or annular rings of plasti- procedural details to make the method 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 or annular rings of vulcan- the closure’s food-contacting surface ized plasticized polymers, with the solvent. including natural or syn- thetic rubber ...... 50 50 50 TABLE 3ÐTYPES OF FOOD 4. Preformed overall discs or annular rings of poly- I. Nonacid (pH above 5.0), aqueous products; may contain meric or resinous-coated salt or sugar or both, and including oil-in-water emulsions paper, paperboard, plas- of low- or high-fat content. tic, or metal foil substrates 50 250 50 II. Acidic (pH 5.0 or below), aqueous products; may contain 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).
236
VerDate 06
TABLE 4ÐTEST 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 1 2 8 percent alcohol 2
A. High temperature heat-sterilized I, IV±B ...... 250 °F, 2 hr ...... (e.g., over 212 °F). III, IV±A, VII ...... do ...... 150 °F, 2 hr. B. Boiling water-sterilized ...... II ...... 212 °F, 30 min ...... III, VII ...... do ...... 120 °F, 30 min. C. Hot filled or pasteurized above 150 II, IV±B ...... Fill boiling, cool to ...... °F. III, IV±A ...... 100 °F. 120 °F, 15 min. V ...... do ...... do...... D. Hot filled or pasteurized below 150 II, IV±B, VI±B ...... 150 °F, 2 hr ...... °F. III, IV±A ...... do ...... 100 °F, 30 min. V ...... do ...... VI±A ...... 150 °F, 2 hr E. Temperature filled and stored (no II, IV±B, VI±B ...... 120 °F, 24 hr ...... thermal treatment in the container). III, IV±A ...... do ...... 70 °F, 30 min. V ...... do ...... VI±A ...... 120 °F, 24 hr. F. Refrigerated storage (no thermal I, II, III, IV±A, IV±B, 70 °F, 48 hr ...... 70 °F, 30 min ...... treatment). VI±B, VII...... 70 °F, 48 hr. VI±A ...... G. Frozen storage (no thermal treat- I, II, III, IV±B, VII ... 70 °F, 24 hr ...... ment in the container). 1 Heptane extractant not applicable to closure-sealing gaskets overcoated with wax. 2 Time and temperature. [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]
§ 177.1240 1,4-Cyclohexylene (c) Any substance employed in the dimethylene terephthalate and 1,4- production of the copolymer that is the cyclohexylene dimethylene subject of a regulation in parts 174, 175, isophthalate copolymer. 176, 177, 178 and § 179.45 of this chapter Copolymer of 1,4-cyclohexylene conforms with any specification in dimethylene terephthalate and 1,4- such regulation. cyclohexylene dimethylene isophtha- (d) Substances employed in the pro- late may be safely used as an article or duction of the copolymer include: component of articles used in pro- (1) Substances generally recognized ducing, manufacturing, packing, proc- as safe in food. essing, preparing, treating, packaging, (2) Substances subject to prior sanc- transporting, or holding food, subject tion or approval for use in the copoly- to the provisions of this section: mer and used in accordance with such (a) The copolymer is a basic poly- sanction or approval. ester produced by the catalytic con- (3) Substances which by regulation in densation of dimethyl terephthalate parts 174, 175, 176, 177, 178 and § 179.45 of and dimethyl isophthalate with 1,4- this chapter may be safely used as cyclohexanedimethanol, to which may components of resinous or polymeric have been added certain optional sub- coatings and film used as food-contact stances required in its production or surfaces, subject to the provisions of added to impart desired physical and such regulation. technical properties. (e) The copolymer conforms with the (b) The quantity of any optional sub- following specifications: stance employed in the production of (1) The copolymer, when extracted the copolymer does not exceed the with distilled water at reflux tempera- amount reasonably required to accom- ture for 2 hours, yields total extrac- plish the intended physical or technical tives not to exceed 0.05 percent. effect or any limitation further pro- vided.
237
VerDate 06
(2) The copolymer, when extracted parts 174, 175, 176, 177, 178, and § 179.45 of with ethyl acetate at reflux tempera- this chapter, it shall also comply with ture for 2 hours, yields total extrac- any specifications and limitations pre- tives not to exceed 0.7 percent. scribed for it by that regulation. (3) The copolymer, when extracted (c) The finished food-contact layer with n-hexane at reflux temperature made with basic copolymers containing for 2 hours, yields total extractives not more than 10 weight-percent but no to exceed 0.05 percent. more than 25 weight-percent of total [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, polymer units derived from acrylic 1984, as amended at 55 FR 34555, Aug. 23, 1990] acid and with a maximum thickness of 0.0025 inch (2.5 mils) may be used in § 177.1310 Ethylene-acrylic acid co- contact with food types I, II, IVB, VIA, polymers. VIB, VIIB, and VIII identified in table The ethylene-acrylic acid copolymers 1 of § 176.170(c) of the chapter under identified in paragraph (a) of this sec- conditions of use B through H as de- tion may be safely used as components scribed in table 2 of § 176.170(c) of this of articles intended for use in contact chapter, and in contact with food types with food subject to the provisions of III, IVA, V, VIIA, and IX identified in this section. table 1 of § 176.170(c) of this chapter (a) The ethylene-acrylic acid copoly- under conditions of use E through G as mers consist of basic copolymers pro- described in table 2 of § 176.170(c) of this duced by the copolymerization of chapter. ethylene and acrylic acid such that the (d) The provisions of this section are finished basic copolymers contain no not applicable to ethylene-acrylic acid more than: copolymers used in food-packaging ad- (1) 10 weight-percent of total polymer hesives complying with § 175.105 of this units derived from acrylic acid when chapter. used in accordance with paragraph (b) [42 FR 14572, Mar. 15, 1977, as amended at 51 of this section; and FR 19060, May 27, 1986; 53 FR 44009, Nov. 1, (2) 25 weight-percent of total polymer 1988] units derived from acrylic acid when used in accordance with paragraph (c) § 177.1312 Ethylene-carbon monoxide of this section. copolymers. (b) The finished food-contact articles The ethylene-carbon monoxide co- made with no more than 10 percent polymers identified in paragraph (a) of total polymer units derived from acryl- this section may be safely used as com- ic acid, when extracted with the sol- ponents of articles intended for use in vent or solvents characterizing the contact with food subject to the provi- type of food and under the conditions sions of this section. of its intended use as determined from (a) Identity. For the purposes of this tables 1 and 2 of § 176.170(c) of this chap- section, ethylene-carbon monoxide co- ter, yield net acidified chloroform-solu- polymers (CAS Reg. No. 25052–62–4) con- ble extractives not to exceed 0.5 milli- sist of the basic polymers produced by gram per square inch of food-contact the copolymerization of ethylene and surface when tested by the methods carbon monoxide such that the copoly- prescribed in § 177.1330(e)(1), (3)(i) mers contain not more than 30 weight- through (iv), (4), (5), and (6), except percent of polymer units derived from that carbon monoxide. (1) The total residue method using 3 (b) Conditions of use. (1) The polymers percent acetic acid, as prescribed in may be safely used as components of § 177.1330(e)(6)(i)(a), does not apply, and the food-contact or interior core layer (2) The net acidified chloroform-solu- of multilaminate food-contact articles. ble extractives from paper and paper- (2) The polymers may be safely used board complying with § 176.170 of this as food-contact materials at tempera- chapter may be corrected for wax, pet- tures not to exceed 121 °C (250 °F). rolatum, and mineral oil as provided in (c) Specifications. (1) Food-contact § 176.170(d)(5)(iii)(b) of this chapter. layers formed from the basic copoly- If the finished food-contact article is mer identified in paragraph (a) of this itself the subject of a regulation in section shall be limited to a thickness
238
VerDate 06
of not more than 0.01 centimeter (0.004 (4) The provisions of this section are inch). not applicable to ethylene-carbon mon- (2) The copolymers identified in para- oxide copolymers complying with graph (a) of this section shall have a § 175.105 of this chapter. melt index not greater than 500 as de- termined by ASTM method D1238–82, [57 FR 32422, July 22, 1992] condition E ‘‘Standard Test Method for § 177.1315 Ethylene-1, 4-cyclohexylene Flow Rates of Thermoplastics by Ex- dimethylene terephthalate copoly- trusion Plastometer,’’ which is incor- mers. porated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Ethylene-1, 4-cyclohexylene Copies may be obtained from the Amer- dimethylene terephthalate copolymer ican Society for Testing Materials, 1916 may be safely used as articles or com- Race St., Philadelphia, PA 19103, or ponents of articles intended for use in may be examined at the Center for contact with food subject to provisions Food Safety and Applied Nutrition of this section and of part 174 of this (HFS–200), Food and Drug Administra- chapter. tion, 200 C St. SW., Washington, DC, or (a) Identity. For the purposes of this at the Office of the Federal Register, section, ethylene-1,4-cyclohexylene 800 North Capitol St. NW., suite 700, dimethylene terephthalate copolymers Washington, DC. (1,4-benzene dicarboxylic acid, di- (3) The basic copolymer identified in methyl ester, polymerized with 1,4- paragraph (a) of this section, when ex- cyclohexanedimethanol and 1,2- tracted with the solvent or solvents ethanediol) (CAS Reg. No. 25640–14–6) or characterizing the type of food and (1,4-benzenedicarboxylic acid, polym- under the conditions of time and tem- erized with 1,4-cyclohexanedimethanol perature characterizing the conditions and 1,2-ethanediol) (CAS Reg. No. of its intended use, as determined from 25038–91–9) are basic copolymers meet- tables 1 and 2 of § 176.170(c) of this chap- ing the specifications prescribed in ter, yields net chloroform-soluble ex- paragraph (b) of this section, to which tractives in each extracting solvent may have been added certain optional not to exceed 0.5 milligram per square substances required in their production inch of food-contact surface when test- or added to impart desired physical or ed by methods described in § 176.170(d) technical properties. of this chapter. (b) Specifications:
239
VerDate 06
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...... 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).
240
VerDate 06
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)
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.
241
VerDate 06
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
242
VerDate 06
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 19103, or may be examined at the Office than 15 weight percent of polymer 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)
243
VerDate 06
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.
244
VerDate 06
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
245
VerDate 06
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]
246
VerDate 06
§ 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 resins may be safely used as articles or copolymer consists of the basic copoly- 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.
247
VerDate 06
(d) Limitations. Copolymer blends de- (6) The copolymer of vinylidene fluo- scribed above shall not exceed 30 per- ride 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 (b) Ethylene-vinyl acetate copoly- identified as Type III, IV–A, V, VII–A, mers, with or without the optional sub- and IX in § 176.170(c), table 1, the co- stances described in paragraph (a) of polymer may be used under condition this section, when extracted with the of use C at temperatures not to exceed solvent or solvents characterizing the 160 °F (71 °C). type of food, and under conditions of [57 FR 43399, Sept. 21, 1992, as amended at 59 time and temperature characterizing FR 62318, Dec. 5, 1994; 61 FR 14481, Apr. 2, the conditions of their intended use as 1996; 62 FR 34628, June 27, 1997] determined from tables 1 and 2 of § 176.170(c) of this chapter, shall yield § 177.1350 Ethylene-vinyl acetate co- net chloroform-soluble extractives cor- polymers. rected for zinc as zinc oleate not to ex- Ethylene-vinyl acetate copolymers ceed 0.5 milligram per square inch of an may be safely used as articles or com- appropriate sample. ponents of articles intended for use in (c) The provisions of paragraph (b) of producing, manufacturing, packing, this section are not applicable to ethyl- processing, preparing, treating, pack- ene-vinyl acetate copolymers used in aging, transporting, or holding food in food-packaging adhesives complying accordance with the following pre- with § 175.105 of this chapter. scribed conditions: (d) Ethylene-vinyl acetate copoly- (a) Ethylene-vinyl acetate copoly- mers may be irradiated under the fol- mers consist of basic resins produced lowing conditions to produce molecular by the catalytic copolymerization of crosslinking of the polymers to impart ethylene and vinyl acetate to which desired properties such as increased may have been added certain optional strength and increased ability to substances to impart desired techno- shrink when exposed to heat: logical or physical properties to the (1) Electron beam source of ionizing resin. Subject to any limitations pre- radiation at a maximum energy of 3 scribed in this section, the optional million electron volts: Maximum ab- substances may include: (1) Substances generally recognized sorbed dose not to exceed 150 kiloGray as safe in food and food packaging. (15 megarads). (2) Substances the use of which is (2) The finished food-contact film permitted under applicable regulations shall meet the extractives limitations in parts 170 through 189 of this chapter, prescribed in paragraph (e)(2) of this prior sanction, or approvals. section. (3) Substances identified in (3) The ethylene-vinyl acetate co- § 175.300(b)(3) (xxv), (xxvii), (xxx), and polymer films may be further irradi- (xxxiii) of this chapter, and colorants ated in accordance with the provisions used in accordance with § 178.3297 of of paragraph (e)(1) of this section: Pro- this chapter. vided, That the total accumulated radi- (4) Erucamide as identified in ation dose from both electron beam § 178.3860 of this chapter. and gamma ray radiation does not ex- (5) Xanthan gum as identified in ceed 150 kiloGray (15 megarads). §172.695 for use as a thickening agent (e) Ethylene-vinyl acetate copolymer at a level not to exceed 1 percent by films intended for contact with food weight of coating solids in aqueous dis- may be irradiated to control the persions of ethylene-vinyl acetate co- growth of microorganisms under the polymers, where such copolymers are following conditions: used only as coatings or a component (1) Gamma photons emitted from a of coatings. cobalt–60 sealed source in the dose
248
VerDate 06
range of 5–50 kiloGray (0.5–5.0 Test Method for Liquid Extraction of megarads). Flexible Barrier Materials,’’ which is (2) The irradiated ethylene-vinyl ace- incorporated by reference. Copies may tate copolymer films, when extracted be obtained from the American Society with reagent grade n-heptane (freshly for Testing Materials, 1916 Race St., redistilled before use) according to Philadelphia, PA 19103, or may be ex- methods described under § 176.170(d)(3) amined at the Office of the Federal of this chapter, at 75 °F for 30 minutes Register, 800 North Capitol Street, shall yield total extractives not to ex- NW., suite 700, Washington, DC 20408. ceed 4.5 percent by weight of the film. (1) The film when extracted with dis- tilled water at 21 °C (70 °F) for 48 hours [42 FR 14572, Mar. 15, 1977, as amended at 43 FR 29287, July 7, 1978; 54 FR 35874, Aug. 30, yields total extractives not to exceed 1989; 55 FR 18595, May 3, 1990; 56 FR 42932, 0.0047 milligram per square centimeter Aug. 30, 1991] (0.03 milligram per square inch) of food-contact surface. § 177.1360 Ethylene-vinyl acetate-vinyl (2) The film when extracted with 50 alcohol copolymers. percent ethyl alcohol at 21 °C (70 °F) for Ethylene-vinyl acetate-vinyl alcohol 48 hours yields total extractives not to copolymers (CAS Reg. No. 26221–27–2) exceed 0.0062 milligram per square cen- may be safely used as articles or com- timeter (0.04 milligram per square ponents of articles intended for use in inch) of food-contact surface. contact with food, in accordance with (c) The finished food-contact article the following prescribed conditions: shall not exceed 0.0076 centimeter (0.003 (a) Ethylene-vinyl acetate-vinyl alco- inch) thickness and shall contact foods hol copolymers are produced by the only of the types identified in table 1 of partial or complete alcoholysis or hy- § 176.170(c) of this chapter in Categories drolysis of those ethylene-vinyl acetate III, IV–A, VII–A, and IX under condi- copolymers complying with § 177.1350. tions of use F and G described in table (1) Those copolymers containing a 2 of § 176.170(c) of this chapter. Film minimum of 55 percent ethylene and a samples of 0.0076 centimeter (0.003 inch) maximum of 30 percent vinyl alcohol thickness representing the finished ar- units by weight may be used in contact ticles shall meet the following extrac- with foods as described in paragraph (b) tive limitation when tested by ASTM of this section. method F34–76 (Reapproved 1980), (2) Those copolymers containing a ‘‘Standard Test Method for Liquid Ex- minimum of 55 percent ethylene and a traction of Flexible Barrier Materials,’’ maximum of 15 percent vinyl alcohol which is incorporated by reference. The units by weight may be used in contact availability of this incorporation by with foods as described in paragraph (c) reference is given in paragraph (b) of of this section. this section. The film when extracted (3) Those copolymers containing 20 to with n-heptane at 38 °C (100 °F) for 30 40 percent ethylene and 60 to 80 percent minutes yields total extractives not to vinyl alcohol units by weight may be exceed 0.0078 milligram per square cen- used in contact with foods as described timeter (0.05 milligram per square in paragraph (d) of this section. inch) of food-contact surface, after cor- (b) The finished food-contact article recting the total extractives by divid- shall not exceed 0.013 centimeter (0.005 ing by a factor of five. inch) thickness and shall contact foods (d) The finished food-contact article only of the types identified in table 1 of shall not exceed 0.018 centimeter (0.007 § 176.170(c) of this chapter in Categories inch) thickness and may contact all I, II, IV–B, VI, VII–B, and VIII under foods except those containing more conditions of use D through G de- than 8 percent alcohol under conditions scribed in table 2 of § 176.170(c) of this of use B through H described in table 2 chapter. Film samples of 0.013 centi- of § 176.170(c) of this chapter. Film sam- meter (0.005) inch thickness rep- ples of 0.018 centimeter (0.007 inch) resenting the finished article shall thickness representing the finished ar- meet the following extractive limita- ticles shall meet the following extrac- tion when tested by ASTM method tive limitation when tested by ASTM F34–76 (Reapproved 1980), ‘‘Standard method F34–76 (Reapproved 1980),
249
VerDate 06
‘‘Standard Test Method for Liquid Ex- St., Philadelphia, PA 19013, or may be traction of Flexible Barrier Materials,’’ examined at the Office of the Federal which is incorporated by reference. The Register, 800 North Capitol Street, availability of this incorporation by NW., suite 700, Washington, DC. reference is given in paragraph (b) of (b) Fluorocarbon resins that are iden- this section. The film when extracted tified in paragraph (a) of this section with distilled water at 100 °C (212 °F) and that comply with extractive limi- for 30 minutes yields total extractives tations prescribed in paragraph (c) of not to exceed 0.023 milligram per this section may be used as articles or square centimeter (0.15 milligram per components of articles intended for use square inch) of food-contact surface. in contact with food as follows: (e) The provisions of this section are (1) Fluorocarbon resins that are iden- not applicable to ethylene-vinyl ace- tified in paragraphs (a)(1), (a)(2), and tate-vinyl alcohol copolymers used in (a)(3) of this section and that comply the food-packaging adhesives com- only with the extractive limitations plying with § 175.105 of this chapter. prescribed in paragraphs (c)(1) and [47 FR 41531, Sept. 21, 1982, as amended at 49 (c)(2) of this section may be used when FR 10108, Mar. 19, 1984] such use is limited to articles or com- ponents of articles that are intended § 177.1380 Fluorocarbon resins. for repeated use in contact with food or Fluorocarbon resins may be safely that are intended for one-time use in used as articles or components of arti- contact with foods only of the types cles intended for use in contact with identified in § 176.170(c) of this chapter, food, in accordance with the following table 1, under Types I, II, VI, VII–B, prescribed conditions: and VIII. (a) For the purpose of this section, (2) Fluorocarbon resins that are iden- fluorocarbon resins consist of basic res- tified in paragraph (a)(4) of this section ins produced as follows: and that comply with the extractive (1) Chlorotrifluoroethylene resins limitations prescribed in paragraphs produced by the homopolymerization (c)(1) and (c)(2) of this section may be of chlorotrifluoroethylene. used only when such use is limited to (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.
250
VerDate 06
(3) A 100-gram sample of the resin with item 2.2 or 3.2 of the table in pellets, when extracted with 100 milli- § 177.1520(c) blended with no more than liters of n-heptane at reflux tempera- 10 percent by weight of a copolymer of ture for 8 hours, shall yield total ex- ethylene and vinyl acetate complying tractives not to exceed 0.01 percent by with § 177.1350. weight of the resins. (c) Polymeric resin blends formulated [42 FR 14572, Mar. 15, 1977, as amended at 57 from a base polymer complying with FR 185, Jan. 3, 1992] item 2.2 or 3.2 of the table in § 177.1520(c) blended with no more than § 177.1390 Laminate structures for use 38 percent by weight of a homopolymer at temperatures of 250 ≥F and of isobutylene complying with above. § 177.1420(a)(1). (a) The high-temperature laminates (d) Polyethylene phthalate resins identified in this section may be safely complying with § 177.1630(e)(4) (i) and used for food contact at temperatures (ii). not exceeding 135 °C (275 °F) unless oth- (e) Nylon MXD–6 resins that comply erwise specified. These articles are lay- with item 10.3 of the table in ered constructions that are optionally § 177.1500(b) of this chapter when ex- bonded with adhesives. The interior tracted with water and heptane under (food-contact) layer(s) may be sepa- the conditions of time and temperature rated from the exterior layer(s) by a specified for condition of use A, as set functional barrier, such as aluminum forth in Table 2 of § 176.170(c) of this foil. Upon review of the physical prop- chapter. erties of a particular construction, the (f) Polymeric resins that comply with Food and Drug Administration may an applicable regulation in this chapter consider other layers to serve as func- which permits food type and time/tem- tional barriers. This regulation is not perature conditions to which the con- intended to limit these constructions tainer will be exposed, including steri- as to shape, degree of flexibility, thick- lization processing. ness, or number of layers. These layers (ii) Adjuvants used in these layers may be laminated, extruded, co- must comply with an applicable regu- extruded, or fused. lation that permits food type and time/ (b) When containers subject to this temperature conditions to which the regulation undergo heat sterilization container will be exposed, including to produce shelf-stable foods, certain sterilization processing. control measures (in addition to the (2) Adhesives. The use of adhesives in food additive requirements in para- these containers is optional. Adhesives graphs (c) and (d) of this section) are may be formulated from the following necessary to ensure proper food steri- substances, subject to the prescribed lization and package integrity. Refer limitations: to parts 108, 110, 113, and 114 of this (i) Any substance suitable for use in chapter for details. formulating adhesives that complies (c) Subject to the provisions of this with an applicable regulation of this paragraph, food-contact articles pro- chapter which permits food type and duced from high-temperature lami- time/temperature conditions to which nates may be safely used to package all the container will be exposed, includ- food types except those containing ing sterilization processing. more than 8 percent ethyl alcohol. (ii) Substances complying with (1) Polymeric films/layers. Films or lay- § 175.105 of this chapter may be used in ers not separated from food by a func- these constructions, provided they are tional barrier must meet the following separated from the interior (food-con- requirements: tact) layer(s) by a functional barrier as (i) Films/layers may consist of the discussed under paragraph (a) of this following: section. (a) Polyolefin resins complying with (iii) Maleic anhydride adduct of poly- item 2.2 or 3.2 of the table in propylene complying with § 175.300 of § 177.1520(c). this chapter. (b) Polymeric resin blends formu- (iv) Polyester-urethane adhesive for lated from a base polymer complying use at temperatures not exceeding 121
251
VerDate 06
°C (250 °F) and formulated from the fol- (3) Epoxy resin listed in lowing: § 175.300(b)(3)(viii)(a) of this chapter and (a) Polyester-urethanediol resin pre- comprising not more than 5 percent by pared by the reaction of a mixture of weight of the cured adhesive. polybasic acids and polyhydric alcohols (4) Optional trimethoxy silane curing listed in § 175.300(b)(3)(vii) of this chap- agents, containing amino, epoxy, ether, ter, 3-isocyanatomethyl-3,5,5- or mercapto groups not in excess of 3 trimethylcyclohexyl isocyanate (CAS percent of the cured adhesive. Reg. No. 4098–71–9) and optional (b) Urethane cross-linking agent, trimethoxysilane coupling agents con- comprising not more than 20 percent taining amino, epoxy, ether, and/or by weight of the cured adhesive, and mercapto groups not to exceed 3 per- cent by weight of the cured adhesive. formulated from trimethylol propane (b) Urethane cross-linking agent (CAS Reg. No. 77–99–6) adducts of 3– comprising not more than 25 percent isocyanatomethyl–3,5,5– by weight of the cured adhesive and trimethylcyclohexyl isocyanate (CAS formulated from 3-isocyanatomethyl- Reg. No. 4098–71–9) or 1,3- 3,5,5-trimethylcyclohexyl isocyanate bis(isocyanatomethyl)benzene (CAS (CAS Reg. No. 4098–71–9) adduct of Reg. No. 25854–16–4). trimethylol propane (Cas Reg. No. 77– (vii) Polyester-polyurethane resin- 99–6) and/or 1,3-bis(isocyanatomethyl) acid dianhydride adhesives for use at benzene (CAS Reg. No. 25854–16–4) temperatures not to exceed 121 °C (250 adduct of trimethylol propane. °F), in contact only with food Types I, (v) Polyester-epoxy-urethane adhe- II, VIA, VIB, VIIB, and VIII as de- sives formulated from the following: scribed in Table I of § 176.170 of this (a) Polyester resin formed by the re- chapter, and formulated from the fol- action of polybasic acids and lowing mixture: polyhydric alcohols listed in (a)(1) Polyesterpolyurethanediol res- § 175.300(b)(3)(vii) of this chapter. Aze- ins prepared by the reaction of a mix- laic acid may also be used as a ture of polybasic acids and polyhydric polybasic acid. alcohols listed in § 175.300(b)(3)(vii) of (b) Epoxy resin listed in this chapter and 3-isocyanatomethyl- § 175.300(b)(3)(viii)(a) of this chapter and 3,5,5-trimethylcyclohexyl isocyanate comprising no more than 30 percent by weight of the cured adhesive. (CAS Reg. No. 4098–71–9). Additionally, (c) Urethane cross-linking agent com- dimethylol propionic acid and 1,6- prising no more than 14 percent weight hexanediol may be used alone or in of the cured adhesive and formulated combination as reactants in lieu of a from 3-isocyanatomethyl-3,5.5- polybasic acid and a polyhydric alco- trimethylcyclohexyl isocyanate hol. cyanurate (CAS Reg. No. 53880–05–0). (2) Acid dianhydride formulated from (vi) Polyurethane-polyester resin- 3a,4,5,7a-tetrahydro-7-methyl-5- epoxy adhesives formulated from the (tetrahydro-2,5-dioxo-3-furanyl)-1,3- following mixture: isobenzofurandione (CAS Reg. No. (a)(1) Polyester-polyurethanediol res- 73003–90–4), comprising not more than ins prepared by the reaction of a mix- one percent of the cured adhesive. ture of polybasic acids and polyhydric (b) Urethane cross-linking agent, alcohols listed in § 175.300(b)(3)(vii) of comprising not more than twelve per- this chapter and 3-isocyanatomethyl- cent by weight of the cured adhesive, 3,5,5-trimethylcyclohexyl isocyanate and formulated from trimethylol pro- (CAS Reg. No. 4098–71–9). pane (CAS Reg. No. 77–99–6) adducts of (2) Polyester resin formed by the re- 3-isocyanatomethyl-3,5,5- action of polybasic acids and trimethylcyclohexyl isocyanate (CAS polyhydric alcohols listed in Reg. No. 4098–71–9) and/or 1,3- § 175.300(b)(3)(vii) of this chapter. Addi- tionally, azelaic acid and 1,6- bis(isocyanatomethyl)benzene (CAS hexanediol may also be used as Reg. No. 363–48–31). reactants in lieu of a polyhydric alco- (3) Test specifications. These specifica- hol. tions apply only to materials on the
252
VerDate 06
food-contact side of a functional bar- 0.0020 milligram per square centimeter rier, if present. All tests must be per- (0.013 milligram per square inch) as de- formed on containers made under pro- termined by a method titled ‘‘Deter- duction conditions. Laminated struc- mination of Non-volatile Chloroform tures submitted to extraction proce- Soluble Residues in Retort Pouch dures must maintain complete struc- Water Extracts,’’ which is incorporated tural integrity (particularly with re- by reference. The availability of this gard to delamination) throughout the incorporation by reference is given in test. paragraph (c)(3)(i)(a)(1) of this section. (i) ) For use Nonvolatile extractives. (a (2) The chloroform-soluble fraction of at temperatures not to exceed 121 °C the total nonvolatile extractives for (250 °F): The container interior (food- containers using adhesives listed in contact side) shall be extracted with deionized distilled water at 121 °C (250 paragraph (c)(2)(v) of this section shall °F) for 2 hours. not exceed 0.016 milligram per square (1) The chloroform-soluble fraction of centimeter (0.10 milligram per square the total nonvolatile extractives for inch) as determined by a method titled containers using adhesives listed in ‘‘Determination of Non-volatile Chlo- paragraphs (c)(2)(i), (c)(2)(ii), (c)(2)(iii), roform Soluble Residues in Retort (c)(2)(iv), and (c)(2)(vii) of this section Pouch Water Extracts,’’ which is incor- shall not exceed 0.0016 milligram per porated by reference. The availability square centimeter (0.01 milligram per of this incorporation by reference is square inch) as determined by a meth- given in paragraph (c)(3)(i)(a)(1) of this od entitled ‘‘Determination of Non- section. Volatile Chloroform Soluble Residues (3) The chloroform-soluble fraction of in Retort Pouch Water Extracts,’’ the total nonvolatile extractives for which is incorporated by reference. containers using adhesives listed in Copies are available from the Center paragraph (c)(2)(vi) of this section shall for Food Safety and Applied Nutrition not exceed 0.008 milligram per square (HFS–200), Food and Drug Administra- centimeter (0.05 milligram per square tion, 200 C St. SW., Washington, DC inch) as determined by a method enti- 20204, and may be examined at the Cen- tled, ‘‘Determination of Non-volatile ter for Food Safety and Applied Nutri- Chloroform Soluble Residues in Retort tion’s Library, 200 C St. SW., rm. 3321, Pouch Water Extracts,’’ which is incor- Washington, DC, or at the Office of the porated by reference in paragraph Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC 20408. (c)(3)(i)(a)(1) of this section. (2) The chloroform-soluble fraction of (ii) Volatiles. Volatile substances em- the total nonvolatile extractives for ployed in the manufacture of high-tem- containers using adhesives listed in perature laminates must be removed to paragraph (c)(2)(v) of this section shall the greatest extent possible in keeping not exceed 0.016 milligram per square with good manufacturing practice pre- centimeter (0.10 milligram per square scribed in § 174.5(a) of this chapter. inch) as determined by a method titled (d) Nylon 12/aluminum foil high-tem- ‘‘Determination of Non-volatile Chlo- perature laminates: Subject to the pro- roform Soluble Residues in Retort visions of this paragraph, containers Pouch Water Extracts,’’ which is incor- constructed of nylon 12 laminated to porated by reference in paragraph aluminum foil may be safely used at (c)(3)(i)(a)(1) of this section. temperatures no greater than 250 °F (b) For use at temperatures not to ex- (121 °C) in contact with all food types ceed 135 °C (275 °F): The container inte- except those containing more than 8 rior (food-contact side) shall be ex- percent alcohol. tracted with deionized distilled water (1) The container is constructed of at 135 °C (275 °F) for 1 hour. aluminum foil to which nylon 12 film is (1) The chloroform-soluble fraction of fused. Prior to fusing the nylon 12, the the total nonvolatile extractives for containers using no adhesive, or adhe- aluminum foil may be optionally sives listed in paragraphs (c)(2) (i), (ii), precoated with a coating complying and (iii) of this section shall not exceed with § 175.300 of this chapter.
253
VerDate 06
(2) Nylon 12 resin complying with (4) The following substances in non- § 177.1500 and having an average thick- food-contact layers only: ness not to exceed 0.0016 inch (41 mi- crons) may be used as the food-contact Substances Limitations surface of the container. Ethylene/1,3±phenylene oxy- For use only with poly- (3) Container test specifications. On ethylene isophthalate/ ethylene terephthalate as exposure to distilled water at 250 °F terephthalate copolymer the food-contact layer, ° (CAS Reg. No. 87365±98±8) complying with (121 C) for 2 hours, extractives from complying with § 177.1345. § 177.1630 under condi- the food-contact side of the nylon 12 tions of use C through G multilayered construction shall not ex- described in table 2 of ceed 0.05 milligram per square inch § 176.170(c) of this chap- ter. Laminate structures, (0.0078 milligram per square centi- when extracted with 8 meter) as total nonvolatile extractives. percent ethanol at 150 °F for 2 hours shall not yield [45 FR 2843, Jan. 15, 1980, as amended at 47 m-pheny lenedioxy-O,O′- FR 49639, Nov. 2, 1982; 48 FR 236, Jan. 4, 1983; diethyl isophthalate or cy- 48 FR 15242, Apr. 8, 1983; 48 FR 17347, Apr. 22, clic bis(ethylene 1983; 49 FR 7558, Mar. 1, 1984; 52 FR 33575, isophthalate) in excess of 7.8 micrograms/square Sept. 4, 1987; 53 FR 39084, Oct. 5, 1988; 54 FR decimeter (0.5 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996; microgram/square inch) of 63 FR 55943, Oct. 20, 1998; 64 FR 4785, Feb. 1, food-contact surface. 1999] Nylon 6/12 resins complying For use with nonalcoholic with § 177.1500(b), item foods at temperatures not 13.2, of this chapter (CAS to exceed 100 °C (212 § 177.1395 Laminate structures for use ° at temperatures between 120 F and Reg. No. 25191±04±2). F). Laminate structures ≥ with authorized food-con- 250 ≥F. tact materials yield no (a) The laminates identified in this more than 0.15 milligram of epsilon-caprolactam section may be safely used at the speci- and 0.04 milligram of fied temperatures. These articles are omega-laurolactam per layered structures that are optionally square inch when ex- tracted with water at 100 bonded with adhesives. In these arti- °C (212 °F) for 5 hours. 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- 24993±04±2).. ceed 82.2 cC (180 cF). ers. The layers may be laminated, ex- Laminate structures with truded, coextruded, or fused. authorized food-contact (b) Laminate structures may be man- materials yield no more than 0.15 milligram of ep- ufactured from: 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 (2) Any polymeric resin listed in cC (180 cF) for 5 hours. 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). with the conditions of use (food type Laminate films with au- thorized food-contact ma- and time/temperature) specified in the terials yield no more than regulation for that resin. 0.15 milligram of epsilon- (3) Optional adjuvant substances used caprolactam per square inch when extracted with in accordance with § 174.5 of this chap- water at 100 cC (212 cF) ter. for 5 hours.
254
VerDate 06
Substances Limitations (c) Any substance employed in the production of the water-insoluble hy- Nylon 6/69 resins complying For use with nonalcoholic with § 177.1500(b), item 14, foods under conditions of droxyethyl cellulose film described in of this chapter (CAS Reg. use B, C, D, E, F, G, and this section that is the subject of a reg- No. 51995±62±1). H described in table 2 of ulation in parts 174, 175, 176, 177, 178 § 176.170 of this chapter. and § 179.45 of this chapter conforms Laminate structures with authorized food-contact with any specification in such regula- materials may contain tion. nylon 6/69 resins pro- vided that the nitrogen § 177.1420 Isobutylene polymers. content of aqueous ex- tracts of a representative Isobutylene polymers may be safely laminate (obtained at 100 used as components of articles in- °C (212 °F) for 8 hours) does not exceed 15 tended for use in producing, manufac- micrograms per square turing, packing, processing, preparing, centimeter (100 treating, packaging, transporting, or micrograms per square holding food, in accordance with the inch). following prescribed conditions: (a) For the purpose of this section, [52 FR 33575, Sept. 4, 1987, as amended at 53 isobutylene polymers are those pro- FR 19772, May 31, 1988; 57 FR 43399, Sept. 21, 1992; 58 FR 32610, June 11, 1993; 62 FR 53957, duced as follows: Oct. 17, 1997] (1) Polyisobutylene produced by the homopolymerization of isobutylene § 177.1400 Hydroxyethyl cellulose film, such that the finished polymers have a water-insoluble. molecular weight of 750,000 (Flory) or Water-insoluble hydroxyethyl cel- higher. lulose film may be safely used for (2) Isobutylene-isoprene copolymers packaging food in accordance with the produced by the copolymerization of following prescribed conditions: isobutylene with not more than 3 (a) Water-insoluble hydroxyethyl cel- molar percent of isoprene such that the lulose film consists of a base sheet finished polymers have a molecular manufactured by the ethoxylation of weight of 300,000 (Flory) or higher. cellulose under controlled conditions, (3) Chlorinated isobutylene-isoprene to which may be added certain optional copolymers produced when substances of a grade of purity suitable isobutylene-isoprene copolymers (mo- for use in food packaging as constitu- lecular weight 300,000 (Flory) or higher) ents of the base sheet or as coatings are modified by chlorination with not applied to impart desired technological more than 1.3 weight-percent of chlo- properties. rine. (b) Subject to any limitations pre- (b) The polymers identified in para- scribed in parts 170 through 189 of this graph (a) of this section may contain chapter, the optional substances used optional adjuvant substances required in the base sheet and coating may in- in the production of the polymers. The clude: optional adjuvant substances required (1) Substances generally recognized in the production of the polymers may as safe in food. include substances generally recog- (2) Substances permitted to be used nized as safe in food, substances used in in water-insoluble hydroxyethyl cel- accordance with a prior sanction or ap- lulose film by prior sanction or ap- proval, and aluminum chloride. proval and under conditions specified (c) The provisions of this section are in such sanctions or approval, and sub- not applicable to polyisobutylene used stances listed in part 181, subpart B of in food-packaging adhesives complying this chapter. with § 175.105 of this chapter. (3) Substances that by any regulation promulgated under section 409 of the § 177.1430 Isobutylene-butene copoly- act may be safely used as components mers. of water-insoluble hydroxyethyl cel- Isobutylene-butene copolymers iden- lulose film. tified in paragraph (a) of this section (4) Substances identified in and used may be safely used as components of in compliance with § 177.1200(c). articles intended for use in contact
255
VerDate 06
with food, subject to the provisions of less than 45 weight percent of polymer this section. units derived from isobutylene and (a) For the purpose of this section, meet the specifications prescribed in isobutylene-butene copolymers consist paragraph (b) of this section when test- of basic copolymers produced by the ed by the methods described in para- copolymerization of isobutylene with graph (c) of this section. mixtures of n-butenes such that the (b) Specifications: finished basic copolymers contain not
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. 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- corporation by reference is given in mining whether isobutylene-butene co- paragraph (c)(1) of this section. polymers conform to the specifications (d) The provisions of this section are in paragraph (b) are as follows: not applicable to isobutylene-butene (1) Molecular weight. Molecular copolymers used as provided under weight shall be determined by Amer- § 175.105 of this chapter. ican Society for Testing and Materials [52 FR 11641, Apr. 10, 1987, as amended at 63 (ASTM) method D2503–82, ‘‘Standard FR 36175, July 2, 1998] Test Method for Molecular Weight (Relative Molecular Mass) of Hydro- § 177.1440 4,4′-Isopropylidenediphenol- carbons by Thermoelectric Measure- epichlorohydrin resins minimum molecular weight 10,000. ment of Vapor Pressure,’’ which is in- corporated by reference. Copies may be 4,4′-Isopropylidenediphenol-epichlo- obtained from the American Society rohydrin resins having a minimum mo- for Testing Materials, 1916 Race St., lecular weight of 10,000 may be safely Philadelphia, PA 19103, or may be ex- used as articles or components of arti- amined at the Office of the Federal cles intended for use in producing, manufacturing, packing, processing, Register, 800 North Capitol Street, preparing, treating, packaging, trans- NW., suite 700, Washington, DC 20408. porting, or holding food in accordance (2) Viscosity. Viscosity shall be deter- with the following prescribed condi- mined by ASTM method D445–74, ‘‘Test tions: for Kinematic Viscosity of Transparent (a) 4,4′-Isopropylidenediphenol-ep- and Opaque Liquids,’’ which is incor- ichlorohydrin resins consist of basic porated by reference. The availability resins produced by the condensation of of this incorporation by reference is equimolar amounts of 4,4′- given in paragraph (c)(1) of this sec- isopropylidenediphenol and tion. epichlorohydrin terminated with phe- (3) Maximum bromine value. Maximum nol, to which may have been added cer- bromine value shall be determined by tain optional adjuvant substances re- ASTM method D1492–78, ‘‘Standard quired in the production of the resins. Test Method for Bromine Index of Aro- (b) The optional adjuvant substances matic Hydrocarbons by Coulometric required in the production of the resins Titration,’’ which is incorporated by may include substances generally rec- reference. The availability of this in- ognized as safe in food, substances used
256
VerDate 06
in accordance with a prior sanction or List of substances Limitations approval, and the following: Colorants used in accord- ance with § 178.3297 List of substances Limitations of this chapter. Butyl alcohol ...... Not to exceed 300 p.p.m. as re- Dioctyl phthalate ...... For use as lubricant. sidual solvent in finished resin. Hexamethylenetetramine For use only as polymerization Ethyl alcohol. reaction control agent. Toluene ...... Not to exceed 1,000 p.p.m. as re- Phthalic acid anhydride .. Do. sidual solvent in finished resin. Zinc stearate ...... For use as lubricant.
(c) 4,4′-Isopropylidenediphenol-ep- (c) The molded melamine-formalde- ichlorohydrin resins shall meet the fol- hyde articles in the finished form in lowing nonvolatile extractives limita- which they are to contact food, when tions: extracted with the solvent or solvents characterizing the type of food and (1) Maximum extractable nonvolatile under the conditions of time and tem- fraction of 2 parts per million when ex- perature as determined from tables 1 ° tracted with distilled water at 70 C for and 2 of § 175.300(d) of this chapter, 2 hours, using a volume-to-surface shall yield net chloroform-soluble ex- ratio of 2 milliliters per square inch. tractives not to exceed 0.5 milligram (2) Maximum extractable nonvolatile per square inch of food-contact surface. fraction of 3 parts per million when ex- tracted with n-heptane at 70 °C for 2 [42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30, 1991] hours, using a volume-to-surface ratio of 2 milliliters per square inch. § 177.1480 Nitrile rubber modified ac- (3) Maximum extractable nonvolatile rylonitrile-methyl acrylate copoly- fraction of 6 parts per million when ex- mers. tracted with 10 percent (by volume) Nitrile rubber modified acrylonitrile- ethyl alcohol in distilled water at 70 °C methyl acrylate copolymers identified for 2 hours, using a volume-to-surface in this section may be safely used as ratio of 2 milliliters per square inch. components of articles intended for (d) The provisions of this section are food-contact use under conditions of not applicable to 4,4′-isopropylidene- use D, E, F, or G described in table 2 of diphenol-epichlorohydrin resins listed § 176.170(c) of this chapter, subject to in other sections of subchapter B of the provisions of this section. this chapter. (a) For the purpose of this section, nitrile rubber modified acrylonitrile- § 177.1460 Melamine-formaldehyde res- methyl acrylate copolymers consist of ins in molded articles. basic copolymers produced by the graft Melamine-formaldehyde resins may copolymerization of 73–77 parts by be safely used as the food-contact sur- weight of acrylonitrile and 23–27 parts face of molded articles intended for use by weight of methyl acrylate in the in producing, manufacturing, packing, presence of 8–10 parts by weight of bu- 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
257
VerDate 06
Vinyl Chloride Polymers,’’ which is in- to be used to fabricate beverage con- corporated by reference. Copies may be tainers. obtained from the American Society [42 FR 14572, Mar. 15, 1977, as amended at 42 for Testing Materials, 1916 Race St., FR 48544, Sept. 23, 1977; 47 FR 11843, Mar. 19, Philadelphia, PA 19103, or may be ex- 1982; 47 FR 16775, Apr. 20, 1982; 49 FR 10109, amined at the Office of the Federal Mar. 19, 1984; 54 FR 24898, June 12, 1989; 61 FR Register, 800 North Capitol Street, 14481, Apr. 2, 1996] NW., suite 700, Washington, DC 20408. § 177.1500 Nylon resins. (iii) Residual acrylonitrile monomer content is not more than 11 parts per The nylon resins listed in paragraph million as determined by gas chroma- (a) of this section may be safely used to tography. produce articles intended for use in (iv) Acetonitrile-soluble fraction processing, handling, and packaging food, subject to the provisions of this after refluxing the base polymer in ace- section: tonitrile for 1 hour is not greater than (a) The nylon resins are manufac- 95 percent by weight of the basic co- tured as described in this paragraph so polymers. as to meet the specifications prescribed (2) Extractives limitations. The fol- in paragraph (b) of this section when lowing extractive limitations are de- tested by the methods described in termined by an infrared paragraph (c) of this section. spectrophotometric method titled, ‘‘In- (1) Nylon 66 resins are manufactured frared Spectrophotometric Determina- by the condensation of hexamethylene- tion of Polymer Extracted from Borex diamine and adipic acid. 210 Resin Pellets,’’ which is incor- (2) Nylon 610 resins are manufactured porated by reference. Copies are avail- by the condensation of hexamethylene- able from the Center for Food Safety diamine and sebacic acid. and Applied Nutrition (HFS–200), Food (3) Nylon 66/610 resins are manufac- and Drug Administration, 200 C St. tured by the condensation of equal- SW., Washington, DC 20204, or available weight mixtures of nylon 66 salts and for inspection at the Office of the Fed- nylon 610 salts. eral Register, 800 North Capitol Street, (4) Nylon 6/66 resins manufactured by NW., suite 700, Washington, DC 20408, the condensation and polymerization of and are applicable to the basic copoly- Nylon 66 salts and epsilon-caprolactam. mers in the form of particles of a size (5) Nylon 11 resins are manufactured that will pass through a U.S. standard by the condensation of 11- sieve No. 6 and that will be held on a aminoundecanoic acid. U.S. standard sieve No. 10: (6) Nylon 6 resins are manufactured (i) Extracted copolymer not to ex- by the polymerization of epsilon- ceed 2.0 parts per million in aqueous caprolactam. extract obtained when a 100-gram sam- (7) Nylon 66T resins are manufac- ple of the basic copolymers is extracted tured by the condensation of hexamethyl-enediamine, adipic acid, with 250 milliliters of demineralized and terephthalic acid such that com- (deionized) water at reflux temperature position in terms of ingredients is for 2 hours. 43.1±0.2 weight percent hexamethyl- (ii) Extracted copolymer not to ex- enediamine, 35.3±1.2 weight percent ceed 0.5 part per million in n-heptane adipic acid, and 21.6±1.2 weight percent extract obtained when a 100-gram sam- terephthalic acid. ple of the basic copolymers is extracted (8) Nylon 612 resins are manufactured with 250 milliliters of reagent grade n- by the condensation of heptane at reflux temperature for 2 hexamethylenediamine and hours. dodecanedioic acid. (c) Acrylonitrile copolymers identi- (9) Nylon 12 resins are manufactured fied in this section shall comply with by the condensation of omega- the provisions of § 180.22 of this chap- laurolactam. ter. (10)(i) Impact modified Nylon MXD–6 (d) Acrylonitrile copolymers identi- resins (CAS Reg. No. 59655–05–9) manu- fied in this section are not authorized factured by the condensation of adipic
258
VerDate 06
acid, 1,3-benzenedimethanamine, and (13)(i) Nylon 6/12 resins (CAS Reg. No. T3alpha-(3-aminopropyl)-omega-(3- 25191–04–2) are manufactured by the co- amino-propoxy)poly- oxyethylene polymerization of a 1 to 1 ratio by under such conditions that the alpha- weight of epsilon-caprolactam and (3-amino-propyl)-omega-(3- omega-laurolactam. aminopropoxy) polyoxyethylene mon- (ii) Nylon 6/12 resins (CAS Reg. No. omer content does not exceed 7 percent 25191–04–2) are manufactured by the co- by weight of the finished resin. polymerization of a ratio of at least 80 (ii) Nylon MXD–6 resins (CAS Reg. weight percent of epsilon-caprolactam No. 25718–70–1) manufactured by the and no more than 20 weight percent of condensation of adipic acid and 1,3- benzenedimethanamine. omega-laurolactam. (11) Nylon 12T resins are manufac- (14) Nylon 6/69 resins (CAS Reg. No. tured by the condensation of omega- 51995–62–1) are manufactured by the laurolactam (CAS Reg. No. 0947–04–6), condensation of 49.5+0.5 weight percent isophthalic acid (CAS Reg. No. 0121–91– epsilon-caprolactam, 19.4+0.2 weight 5), and bis(4-amino-3-methylcycl- percent hexamethylenediamine and ohexyl)methane (CAS Reg. No. 6864–37– 31.2+0.3 weight percent azelaic acid. 5) such that the composition in terms (15) Nylon 46 resins (CAS Reg. No. of ingredients is 34.4±1.5 weight percent 50327–77–0) are manufactured by the omega-laurolactam, 26.8±0.4 weight per- condensation of 1,4-butanediamine and cent isophthalic acid, and 38.8±0.5 adipic acid. weight percent bis(4-amino-3- (16) Nylon resins PA 6–3–T (CAS Reg- methylcyclohexyl)-methane. istry No. 26246–77–5) are manufactured (12) Nylon 6I/6T resins (CAS Reg. No. by the condensation of 50 mol percent 25750–23–6) are manufactured by the 1,4-benzenedicarboxylic acid, dimethyl condensation of hexamethylenediamine, terephthalic ester and 50 mol percent of an acid, and isophthalic acid such that 65 equimolar mixture of 2,2,4-trimethyl- to 80 percent of the polymer units are 1,6-hexanediamine and 2,4,4-trimethyl- derived from hexamethylene 1,6-hexanediamine. isophthalamide. (b) Specifications:
259
VerDate 06
N ...... HC1 after 1 h h. after 1 h h. after 1 h h. Solubility in boiling 4.2 ...... do ...... do Insoluble Dissolves in 1 Insoluble Dissolves in 1 Insoluble ...... do Dissolves in 1 ...... do ...... do ...... do 482±518 475±495 405±425 355±375 392±446 392±446 406±420 375±395 355±375 335±355 440±460 380±425 enheit) Melting point (de- grees Fahr- .015 .015 .015 .015 .015 .015 .015 .015 .015 .015 .015 .015 ± ± ± ± ± ± ± ± ± ± ± ± 1.15 1.06 1.10 1.04 1.04 1.01 1.13 1.14 1.16 1.14 1.09 1.15 Specific gravity ......
epsi- . . . F), and B through ° ...... caprolactam monomer . F. ° ......
epsilon- 175.300 of this chapter Nylon resins ...... 176.170(c) of this chapter, except ...... 177.1390(d). . . caprolactam monomer content not to exceed Nylon 6/66 resins, Nylon 6/66 resins with combined caprolactam with food time use in contact with food and which are compliance with § 177.1395 of this chapter (CAS Reg. No. 24993± H of table 2 § content greater than 60 percent and residual time use or repeated in contact with food a. In articles intended for repeated use in contact b. In side-seam cements for articles intended 1- having an average thickness not to exceed 0.001 in having an average thickness not to exceed 0.001 in for repeated use in contact with food at tempera- tures not to exceed 212 not to exceed 0.0016 inch intended for use in con- tact with nonalcoholic food under the conditions of use A (sterilization not to exceed 30 minutes at a temperature not to exceed 250 as provided in § 0.4 percent by weight. For use only as specified in § 04±2) content not to exceed 0.7 percent by weight lon- 1. Nylon 66 resins 2. Nylon 610 resins 3.1 Nylon 66/610 resins 4.1 4.2 5.1 Nylon 11 resins for use in articles intended 1- 5.2 Nylon 11 resins for use only: 6.1 Nylon 6 resins 6.2 Nylon 6 resins for use only in food-contact films 7. Nylon 66T resins for use only in food-contact films 8. Nylon 612 resins for use only in articles intended 9. Nylon 12 resins for use only: a. In food-contact films having an average thickness
260
VerDate 06
° m . . . 176.170(c) of this chapter . 176.170(c) of this chapter, shall . 176.170(C) of this chapter F) (conditions of use E, F, and G in table 2 ° 176.170(c) of this chapter, except those con- 176.170(c) of this chapter. 176.170(c) of this chapter) 177.1520(c), item 1.1(a) and 1.1(b), of this chap- taining more than 8 percent alcohol, under condi- tions of use B through H described in table 2 § (120 § ter. The finished food-contact laminate, in the form in which it contacts food, when extracted with the food simulating solvent or solvents characterizing the conditions of intended use as determined from Table 2 of § yield not more than 0.5 micrograms of with all food types described in table 1 of § 6 film having an average thickness not to exceed 40 microns (0.0016 inch) for use in processing, handling, and packaging of food types V IX listed in table 1 of § polymer use as modifiers in Nylon 6 resin films complying with paragraph (a)(6) of this sec- tion, at levels not to exceed 13 percent by weight of films whose average thickness will not exceed 15 microns (0.6 mils). The finished film is used for packaging, transporting, or holding food, excluding beverages containing more than 8 percent alcohol (by volume) at temperatures not to exceed 49 contact layers of: (1) Multilayer films and (2) rigid plastic containers composed of polypropylene food- contact and exterior layers, as defined in § of food except those containing more than 8 per- cent alcohol of food except alcoholic beverages containing more than 8 percent alcohol under conditions of use C, D, E, F, G, and H in table 2 of § xylylenediamine-adipic acid cyclic monomer per square inch of food-contact surface, when the food simulating solvent is analyzed by any appropriate, properly validated method b. In coatings intended for repeated use in contact 10.1 Nylon MXD±6 and impact modified MXD± 10.2 Impact modified Nylon MXD±6 resins for use as 10.3 Nylon MXD±6 resins for use only as nonfood- 11. Nylon 12T resins for use in contact with all types 12. Nylon 6I/6T resins for use in contact with all types
261
VerDate 06
N . . HC1 . . h. hour h. after 1 h. Solubility in boiling 4.2 ...... Dissolves in 1 Dissolves in 1 Dissolves in 1 Insoluble NA 380±400 270±277 260±285 enheit) Melting point (de- 551±09592 grees Fahr- 0.03 0.15 0.02 ± ± ± 0.015 0.015 ± ± 1.12 1.10 1.09 1.06 1.18 Specific gravity -
epsilon . . C. ° . . . 176.170(c) of this chapter -laurolactam not to exceed 0.1 Nylon resins
omega 176.170(c) of this chapter with a hot-fill 177.1395 of this chapter 176.170(c) of this chapter 176.170(c) of this chapter percent by weight. For use only as specified in § films having an average thickness not to exceed 51 microns (0.002 inch). The finished film is intended to contact all foods except those containing more than 8 percent ethanol under conditions of use B, C, D, E, F, G, and H listed in table 2 of § CFR 177.1395 of this chapter brane filters intended for repeated use. The finished membrane filter is intended to contact beverages containing no more than 13 percent alcohol, under conditions of use E, F, and G listed in table 2 § ing bottles) in contact with food of type VIA and VIB described in table 1 of § under conditions of use D through H described in table 2 of § temperature limitation of 40 caprolactam not to exceed 0.5 percent by weight and residual 13.1 Nylon 6/12 resins for use only in food-contact 13.2 Nylon 6/12 resins with residual 14. Nylon 6/69 resins for use only as specified in 21 15. Nylon 46 resins for use only in food-contact mem- 16. Nylon resins PA 6±3±T for repeated-use (exclud-
262
VerDate 06
(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- to –25 cC. 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
263
VerDate 06
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 in the Finding Aids 5 inches in diameter, a suction flask, section of this volume. and a hardened filter paper (Whatman § 177.1520 Olefin polymers. No. 50 or equivalent). The paper is wet with the solvent and a slight suction The olefin polymers listed in para- applied just before starting the filtra- graph (a) of this section may be safely tion. The resin is washed twice with used as articles or components of arti- approximately 100-milliliter portions of cles intended for use in contact with solvent and the combined filtrate and food, subject to the provisions of this washings are reduced to approximately section. 25 milliliters by evaporation at reduced (a) For the purpose of this section, pressure (50 millimeters to 100 millime- olefin polymers are basic polymers ters of mercury, absolute), heating as manufactured as described in this para- necessary. The contents of the flask graph, so as to meet the specifications are transferred to an evaporation dish prescribed in paragraph (c) of this sec- (which has been held in a vacuum des- tion, when tested by the methods de- iccator over anhydrous calcium sulfate scribed in paragraph (d) of this section. until constant weight has been at- (1)(i) Polypropylene consists of basic tained) and carefully evaporated to polymers manufactured by the cata- dryness. The weight of the solid residue lytic polymerization of propylene. is determined by difference after hold- (ii) Propylene homopolymer consists ing in a vacuum desiccator over anhy- of basic polymers manufactured by the drous calcium sulfate until constant catalytic polymerization of propylene weight has been attained. The percent with a metallocene catalyst. of solids extracted is calculated by di- (2) Polyethylene consists of basic viding the weight of the solid residue polymers manufactured by the cata- by the weight of the sample and multi- lytic polymerization of ethylene. plying by 100. (3) Olefin basic copolymers consist of (5) Viscosity number (VN). (i) The vis- basic copolymers manufactured by the cosity number (VN) for Nylon 6/12 resin catalytic copolymerization of: in a 96 percent sulfuric acid solution (5 (i) Two or more of the 1-alkenes hav- milligrams resin per milliliter) shall be ing 2 to 8 carbon atoms. Such olefin determined at 25 °C (77 °F) by method basic copolymers contain not less than ISO 307–1984(E), ‘‘Plastics-Polyamides- 96 weight-percent of polymer units de- Determination of Viscosity Number,’’ rived from ethylene and/or propylene, which is incorporated by reference. except that:
264
VerDate 06
(a)(1) Olefin basic copolymers manu- mer units derived from 4- factured by the catalytic copolym- methylpentene-1; or erization of ethylene and hexene-1 or (iii) Ethylene and propylene that ethylene and octene-1 shall contain not may contain as modifiers not more less than 90 weight-percent of polymer than 5 weight-percent of total polymer units derived from ethylene; units derived by copolymerization with (2) Olefin basic copolymers manufac- one or more of the following mono- tured by the catalytic copolymeriza- mers: tion of ethylene and hexene-1 shall con- tain not less than 80 but not more than 5-Ethylidine-2-norbornene. 90 weight percent of polymer units de- 5-Methylene-2-norbornene. rived from ethylene. (iv) Ethylene and propylene that may (3) Olefin basic copolymers manufac- contain as a modifier not more than 4.5 tured by the catalytic copolymeriza- weight percent of total polymer units tion of ethylene and pentene-1 shall derived by copolymerization with 1,4- contain not less than 90 weight-percent hexadiene. of polymer units derived from ethyl- (v) Ethylene and butene-1 copolymers ene. (CAS Reg. No. 25087–34–7) that shall (b) Olefin basic copolymers manufac- contain not less than 80 weight percent tured by the catalytic copolymeriza- of polymer units derived from ethyl- tion of ethylene and 4-methylpentene-1 ene. shall contain not less than 89 weight- (4) Poly(methylpentene) consists of percent of polymer units derived from basic polymers manufactured by the ethylene; catalytic polymerization of 4- (c)(1) Olefin basic copolymers manu- methylpentene-1. factured by the catalytic copolym- (5) Polyethylene graft copolymers erization of two or more of the mono- mers ethylene, propylene, butene-1, 2- consist of polyethylene complying with methylpropene-1, and 2,4,4- item 2.2 of paragraph (c) of this section trimethylpentene-1 shall contain not which subsequently has 3a,4,7,7a- less than 85 weight-percent of polymer tetrahydromethyl-4,7- units derived from ethylene and/or pro- methanoisobenzofuran-1,3-dione graft- pylene; ed onto it at a level not to exceed 1.7 (2) Olefin basic copolymers manufac- percent by weight of the finished co- tured by the catalytic copolymeriza- polymer. tion of propylene and butene-1 shall (6) Ethylene-maleic anhydride co- contain greater than 15 but not greater polymers (CAS Reg. No. 9006–26–2) con- than 35 weight percent of polymer taining no more than 2 percent by units derived from butene-1 with the weight of copolymer units derived from remainder being propylene. maleic anhydride. (d) Olefin basic terpolymers manufac- (b) The basic olefin polymers identi- tured by the catalytic copolymeriza- fied in paragraph (a) of this section tion of ethylene, hexene-1, and either may contain optional adjuvant sub- propylene or butene-1, shall contain stances required in the production of not less than 85 weight percent poly- such basic olefin polymers. The op- mer units derived from ethylene. tional adjuvant substances required in (e) Olefin basic copolymers manufac- the production of the basic olefin poly- tured by the catalytic polymerization mers or finished food-contact articles of ethylene and octene-1, or ethylene, may include substances permitted for octene-1, and either hexene-1, butene-1, such use by applicable regulations in propylene, or 4-methylpentene-1 shall parts 170 through 189 of this chapter, contain not less than 80 weight percent substances generally recognized as safe of polymer units derived from ethyl- in food and food packaging, substances ene. used in accordance with a prior sanc- (ii) 4-Methylpentene-1 and 1-alkenes tion or approval, and the following: having 6 to 10 carbon atoms. Such olefin basic copolymers shall contain not less than 95 molar percent of poly-
265
VerDate 06
Substance Limitations
Aromatic petroleum hydrocarbon resin, hydrogenated (CAS For use only as an adjuvant at levels not to exceed 25 percent Reg. No. 88526±47±0), produced by the catalytic polym- by weight in blends with polypropylene complying with para- erization of aromatic-substituted olefins from distillates of graph (c), item 1.1 of this section. The finished polymer may cracked petroleum stocks with a boiling point no greater than be used in contact with food Types I, II, IV±B, VI±A through 220 °C (428 °F), and the subsequent catalytic hydrogenation VI±C, VII±B, and VIII identified in table 1 of § 176.170(c) of of the resulting aromatic petroleum hydrocarbon resin, hav- this chapter and under conditions of use B through H de- ing a minimum softening point of 110 °C (230 °F), as deter- scribed in table 2 of § 176.170(c) of this chapter; and with mined by ASTM Method E 28±67 (Reapproved 1982), food Types III, IV±A, V, VII±A, and IX identified in table 1 of ``Standard Test Method for Softening Point by Ring-and-Ball § 176.170(c) of this chapter and under conditions of use D Apparatus,'' and a minimum aniline point of 107 °C (225 °F), through G described in table 2 of § 176.170(c) of this chap- as determined by ASTM Method D 611±82, ``Standard Test ter. Methods for Aniline Point and Mixed Aniline Point of Petro- leum Products and Hydrocarbon Solvents,'' both of which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the American Society for Testing and Materials, 1916 Race St., Philadelphia, PA 19103, or from the Center for Food Safety and Applied Nutrition (HFS±200), Food and Drug Administra- tion, 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. 78± For use as an initiator in the production of propylene 63±7). homopolymer complying with § 177.1520(c), item 1.1 and olefin copolymers complying with § 177.1520(c), items 3.1 and 3.2 and containing not less than 75 weight percent of polymer units derived from propylene, provided that the 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 (HFS± 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. Methyl methacrylate/butyl acrylate-grafted polypropylene co- For use only at levels not to exceed 6 percent by weight of polymer containing methyl methacrylate/butyl acrylate-grafted olefin polymers complying with paragraph (c) of this section, polypropylene (CAS Reg. No. 121510±09±6), methyl meth- items 1.1, 3.1a, 3.2a, and 3.2b, where the copolymers com- acrylate/butyl acrylate copolymer (CAS Reg. No. 25852±37± plying with items 3.1a, 3.2a, and 3.2b contain not less than 3), methyl methacrylate homopolymer (CAS Reg. No. 9011± 85 weight-percent of polymer units derived from propylene. 14±7), and polypropylene (CAS Reg. No. 9003±07±0), 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 PP±MMA/BA Polymers,'' which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Premarket Approval, Center for Food Safety and Applied Nutrition (HFS±200), Food and Drug Administration, 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.
266
VerDate 06
Substance Limitations
Petroleum hydrocarbon resins (cyclopentadiene-type), hydro- For use only as an adjuvant at levels not to exceed 30 percent genated (CAS Reg. No. 68132±00±3) produced by the ther- by weight in blends with: (1) Polypropylene complying with mal polymerization of dicyclopentadiene and cyclodiene paragraph (c), item 1.1 of this section, or (2) a copolymer of codimers (consisting of a mixture of cyclopentadiene, methyl propylene and ethylene containing not less than 94 weight cyclopentadiene, and C4±C5 acyclic dienes), followed by hy- percent propylene and complying with paragraph (c), item drogenation and having a ring-and-ball softening point of 119 3.2 of this section. The average thickness of the food-con- °C minimum as determined by ASTM Method E 28±67 (Re- tact film is not to exceed 0.1 millimeter (0.004 inch). The fin- approved 1982), ``Standard Test Method for Softening Point ished polymer may be used in contact with (1) Food types I, by Ring-and-Ball Apparatus,'' and a minimum viscosity of II, IV±B, VI±A, VI±B, VII±B, and VIII identified in table 1 of 3,000 centipoise, measured at 160 °C, as determined by § 176.170(c) of this chapter and under conditions of use C ASTM Method D 3236±88, ``Standard Test Method for Ap- through G described in table 2 of § 176.170(c) of this chap- parent Viscosity of Hot Melt Adhesives and Coating Mate- ter; and (2) food types III, IV±A, V, VI±C, VII±A, and IX iden- rials,'' both of which are incorporated by reference in accord- tified in table 1 of § 176.170(c) of this chapter and under ance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are conditions of use D through G described in table 2 of available from the American Society for Testing and Mate- § 176.170(c) of this chapter. rials, 1916 Race St., Philadelphia, PA 19103, or from the Center For Food Safety and Applied Nutrition (HFS±200), Food and Drug Administration, 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. 68554±70±1) ...... For use only as a surface lubricant or anti-blocking agent in films. Poly(vinylidene fluoride) homopolymer (CAS Reg. No. 24937± For use only as a processing aid in the production of olefin 79±9), having a melt viscosity of 6 to 37 kilopoise at a shear polymers complying with paragraph (c) of this section at lev- rate of 100¥1 seconds at 232 °C as determined by ASTM els not to exceed 1.0 percent by weight of the polymer. The Method D 3835±79 (Reapproved 1983), ``Standard Test finished polymers may be used only under the conditions de- Method for Rheological Properties of Thermoplastics with a scribed in § 176.170(c) of this chapter, table 2, under condi- Capillary Rheometer'' using a capillary of 15:1 L/D, which is tions of use B though H. incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS±200), Food and Drug Administration, 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 68937±54±2). 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. Triisopropanolamine (CAS Reg. No. 122±20±3) ...... 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. 108±75±8), not less than 60 percent; 2,3,6- 1.3, and propylene copolymers complying with items 3.1, trimethylpyridine (CAS Reg. No. 1462±84±6), not more than and 3.2 of paragraph (c) of this section provided that the ad- 27 percent; 3,5-dimethylpyridine (CAS Reg. No. 591±22±0), juvant is used at a level not to exceed 20 parts per million not more than 12 percent; and other dimethylpyridines, not by weight of the olefin polymers. more than 6 percent. Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as an extrusion aid in the production of extruded No. 9011±17±0) having a fluorine content of 65 to 71 per- olefin polymers at levels not to exceed 0.2 percent by weight cent and a Mooney viscosity of at least 28, as determined by of the polymer. The finished polymers may be used only a method entitled ``Mooney Viscosity,'' which is incorporated under the conditions described in § 176.170(c) of this chap- by reference in accordance with 5 U.S.C. 552(a). Copies are ter, table 2, under conditions of use B through H. available from the Center for Food Safety and Applied Nutri- tion (HFS±200), Food and Drug Administration, 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.
267
VerDate 06
Substance Limitations
Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as a processing aid in the production of olefin No. 9011±17±0), having a vinylidene fluoride content of not polymers complying with paragraph (c) of this section at lev- less than 87 percent but less than 100 percent by weight els not to exceed 1.0 percent by weight of the polymer. The and a melt viscosity of 12 to 27 kilopoise at a shear rate of finished polymers may be used only under the conditions de- 100¥1 seconds at 232 °C as determined by ASTM Method D scribed in § 176.170(c) of this chapter, table 2, under condi- 3835±79 (Reapproved 1983), ``Standard Test Method for tions of use B though H. Rheological Properties of Thermoplastics with a Capillary Rheometer'' using a capillary of 15:1 L/D, which is 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 (HFS±200), 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)± hexane at speci- lene at specified fied temperatures temperatures
1.1a Polypropylene described in paragraph 0.880±0.913 MP: 160°±180 °C 6.4 pct at reflux 9.8 pct at 25 °C (a)(1)(i) of this section temperature 1.1b Propylene homopolymer described in 0.880±0.913± MP: 150°±180 °C 6.4 pct at reflux 9.8 pct at 25 °C paragraph (a)(1)(ii) of this section temperature. 1.2 Polypropylene, noncrystalline; for use only 0.80±0.88 to plasticize polyethylene described under items 2.1 and 2.2 of this table, provided that such plasticized polymers meet the max- imum extractable fraction and maximum soluble fraction specifications prescribed for such basic polyethylene 1.3 Polypropylene, noncrystalline, for use 0.80±0.88 SP:115°±138 °C. only: To plasticize polypropylene described by item 1.1 of this table, provided that such plasticized polymers meet the maximum 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, IV±B, VI±B, VII±B, and VIII; and for use at levels not to exceed 50 pct by weight of any mixture employed as a food- contact coating provided such coatings con- tact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, II, IV±B, VI±B, VII±B, and VIII 2.1 Polyethylene for use in articles that con- 0.85±1.00 ...... 5.5 pct at 50 °C 11.3 pct at 25 °C tact food except for articles used for pack- ing or holding food during cooking 2.2 Polyethylene for use in articles used for 0.85±1.00 ...... 2.6 pct at 50 °C Do. packing or holding food during cooking 2.3 Polyethylene for use only as component 0.85±1.00 ...... 53 pct at 50 °C 75 pct at 25 °C of food-contact coatings at levels up to and including 50 percent by weight of any mix- ture employed as a food-contact coating
268
VerDate 06
Maximum extract- Maximum soluble Melting Point able fraction (ex- fraction (ex- (MP) or softening pressed as per- pressed as per- Olefin polymers Density point (SP) (De- cent by weight of cent by weight of grees Centi- the polymer) in N- polymer) in xy- grade)± hexane at speci- lene at specified fied temperatures temperatures
3.1a Olefin copolymers described in para- 0.85±1.00 ...... 5.5 pct at 50 °C 30 pct at 25 °C graph (a)(3)(i) of this section for use in 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- 0.9±1.00 ...... Do. Do. graph (a)(3)(i)(e) of this section for use in contact with food only under conditions of use D, E, F, G, and H described in § 176.170(c) of this chapter, table 2 3.1c Olefin copolymers described in para- Not less than 0.92 graph (a)(3)(i)(a)(3) of this section for use in contact with food only under conditions of use B, C, D, E, F, G, and H described in § 176.170(c) of this chapter, table 2; except that such copolymers when used in contact with food of the types identified in § 176.170(c), table 1, under types III, IVA, V, VIIA, and IX, shall be used only under conditions of use D, E, F, and G described in § 176.170(c) of this chapter, table 2. 3.2a Olefin copolymers described in para- 0.85±1.00 ...... 2.6 pct at 50 °C Do. graph (a)(3)(i) of this section for use in 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 3.3a Olefin polymers described in paragraph 0.82±0.85 MP: 235±250 °C 6.6 pct at reflux 7.5 pct at 25 °C (a)(3)(ii) of this section.
269
VerDate 06
Maximum extract- Maximum soluble Melting Point able fraction (ex- fraction (ex- (MP) or softening pressed as per- pressed as per- Olefin polymers Density point (SP) (De- cent by weight of cent by weight of grees Centi- the polymer) in N- polymer) in xy- grade)± hexane at speci- lene at specified fied temperatures temperatures
3.3b Olefin copolymers described in para- 0.82±0.85 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 3.4 Olefin copolymers, primarily non-crys- 0.85±0.90 talline, described in par. (a)(3) (iii) of this section provided that such olefin polymers have a minimum viscosity average 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- 0.85±0.90 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
270
VerDate 06
Maximum extract- Maximum soluble Melting Point able fraction (ex- fraction (ex- (MP) or softening pressed as per- pressed as per- Olefin polymers Density point (SP) (De- cent by weight of cent by weight of grees Centi- the polymer) in N- polymer) in xy- grade)± hexane at speci- lene at specified fied temperatures temperatures
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, IV±B, 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. 4. Poly(methylpentene) 0.82±0.85 MP: 235°±250 °C 6.6 pct at reflux 7.5 pct at 25 °C temperature 5. Polyethylene copolymer described in para- Not less than 0.94 ...... 0.45 pct at 15 °C 1.8 pct at 25 °C graph (a)(5) of this section and having a melt index not to exceed 2, for use, either alone or in blends with other olefin 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±0.94 ...... 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- Gradient Technique,’’ which is incor- mining whether olefin polymers con- porated by reference. Copies may be form to the specifications prescribed in obtained from the American Society this section are as follows, and are ap- for Testing Materials, 1916 Race St., plicable to the basic polymer in film Philadelphia, PA 19103, or may be ex- form not exceeding 4 mils in thickness. amined at the Office of the Federal The film to be tested shall be cut into Register, 800 North Capitol Street, approximately 1-inch squares by any NW., suite 700, Washington, DC 20408. convenient method that avoids con- (2) Melting point or softening point—(i) tamination by dust, dirt, or grease Melting point. The melting point shall (NOTE: Do not touch samples with bare be determined by ASTM method D2117– fingers—use forceps to hold or transfer 82, ‘‘Standard Test Method for Melting samples). Point of Semicrystalline Polymers by (1) Density. Density shall be deter- the Hot Stage Microscopy Method,’’ mined by ASTM method D1505–68 (Re- which is incorporated by reference. The approved 1979), ‘‘Standard Test Method availability of this incorporation by for Density of Plastics by the Density-
271
VerDate 06
reference is given in paragraph (d)(1) of (5) Bell jar for vacuum filtration into this section. beaker. (ii) Softening point. The softening (b) Reagent. n-Hexane, commercial point shall be determined by ASTM grade, specific gravity 0.663–0.667 (20 °C/ method E28–67 (Reapproved 1982), 20 °C), boiling range 66 °C-69 °C, or ‘‘Standard Test Method for Softening equivalent. Point by Ring-and-Ball Apparatus,’’ (c) Procedure. Weigh 1 gram of sample which is incorporated by reference. The accurately and place in a 250-milliliter availability of this incorporation by Erlenmeyer flask containing two or reference is given in paragraph (d)(1) of three boiling stones. Add 100 milliliters this section. of solvent, attach the flask to the con- (3) Maximum extractable fraction in n- denser (use no grease), and reflux the hexane—(i) Olefin copolymers described mixture for 2 hours. Remove the flask in paragraph (a)(3)(ii) of this section, from the heat, disconnect the con- denser, and filter rapidly, while still polypropylene, and poly(methylpentene). hot, through a small wad of glass wool A sample is refluxed in the solvent for packed in a short-stem funnel into a 2 hours and filtered at the boiling tared 150-millimeter beaker. Rinse the point. The filtrate is evaporated and flask and filter with two 10-milliliter the total residue weighed as a measure portions of the hot solvent, and add the of the solvent extractable fraction. rinsings to the filtrate. Evaporate the (a) Apparatus. (1) Erlenmeyer flasks, filtrate on a stream bath with the aid 250-milliliter, with ground joint. of a stream of nitrogen. Dry the res- (2) Condensers, Allihn, 400-millimeter idue in a vacuum oven at 110 °C for 2 jacket, with ground joint. hours, cool in a desiccator, and weigh (3) Funnels, ribbed 75-millimeter di- to the nearest 0.0001 gram. Determine ameter, stem cut to 40 millimeters. the blank on 120 milliliters of solvent (4) Funnels, Buchner type, with evaporated in a tared 150-milliliter coarse-porosity fritted disc, 60-milli- beaker. Correct the sample residue for meter diameter. this blank if significant. Calculation:
Grams of residue = Percent extractable with n-hexane. Grams of sample ×100
(ii) Olefin copolymers described in para- sion-proof electric motor, and a reflux graph (a)(3)(i) of this section and poly- condenser. The kettle is fitted with an ethylene. A preweighed sample is ex- electric heating mantle of appropriate tracted at 50 °C for 2 hours and filtered. size and shape, which is controlled by a The filtrate is evaporated and the total variable-voltage transformer. residue weighed as a measure of the (b) Evaporating apparatus. Rapid solvent extractable fraction. Alter- evaporation of large volumes of solvent natively, the sample is reweighed after requires special precautions to prevent the extraction period to give a measure contamination by dust. This is facili- of the solvent extractable fraction. The tated by a special ‘‘gas’’ cover con- maximum n-hexane-extractable frac- sisting of an inverted flat Pyrex crys- tion may be determined by the meth- tallizing dish of an appropriate size (190 ods set forth in paragraphs (d)(3)(ii)(a) millimeters × 100 millimeters) to fit a through (d)(3)(ii)(i) of this section. 1-liter beaker. Through the center of (a) Extraction apparatus. Two-liter, the dish are sealed an inlet tube for straight-walled, Pyrex (or equivalent) preheated, oxygen-free nitrogen, and resin kettles, fitted with three-hole an outlet tube located 1 inch off center. ground-glass covers are most conven- Nitrogen is fed from the supply source ient for this purpose. The cover is through a coil of 1⁄4-inch stainless steel fitted with a thermometer, a gas-tight tubing immersed in the same steam stirrer driven by an air motor or explo- bath used to supply heat for solvent
272
VerDate 06
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 temperature of the contents to 50 °C vacuum desiccator, and allow it to re- within 20–25 minutes. As the thermom- main overnight (at least 12 hours), eter reading approaches 45 °C–47 °C, re- after which the net weight of the dry duce the voltage to the predetermined residue is determined to the nearest setting that will just maintain the 0.0001 gram. Correct the result for any temperature at 50 °C. Do not overshoot solvent blank equivalent to the non- the prescribed temperature. Should volatile matter determined to be con- this occur discard the test and start tained in the amount of solvents used afresh. Exactly 2 hours after the sol- in the test. vent temperature has reached 50 °C, (e) Extraction apparatus for alternate disconnect the heater, remove the resin method. Two-liter extraction vessel, kettle from the heating jacket, and de- such as a resin kettle or round bottom cant the solvent, while still warm, flask, fitted with an Allihn condenser through a coarse filter paper placed on (size C), a 45/50 male joint with a Teflon top of a fritted-glass funnel, collecting sleeve, and a Teflon coated stir bar. the filtrate in a tared, glass-stoppered Water bath maintained at 49.5 °C ±0.5 Erlenmeyer flask of 1-liter capacity. °C containing a submersible magnetic Determine the weight of the filtrate re- stirrer motor with power supply. Other covered to the nearest gram. Recovery suitable means of maintaining tem- should be at least 90 percent of the perature control, such as electric heat- original solvent. Losses due to evapo- ing mantles, may be used provided that ration during heating and filtering the temperature range can be strictly have been found not to exceed 10 per- maintained. cent. Transfer about half of the solvent (f) Sample basket (Optional). A per- filtrate to a 1-liter beaker placed on an forated stainless steel cylindrical bas- opening in the steam bath and imme- ket that is approximately 1.5 inches in diately cover with the special ‘‘gas’’ cover, the inlet tube of which has been diameter, 1.6 inches high, and has per- attached with flexible tetrafluoro- forations of 0.125 inches in diameter for ethylene tubing to a source of high-pu- 33 holes/in2, or 40 percent open area. rity nitrogen in series with a stainless The basket should pass freely through steel heating coil immersed directly in the 45/50 female joint of the extraction the body of the steam bath. Maintain a flask. A No. 6–32 stainless steel eye- positive flow of warm nitrogen gas bolt is attached to the lid for posi- throughout the evaporation of the sol- tioning the basket in the extraction vent, adding the remainder of the fil- vessel. The positioning rod, approxi- trate from the Erlenmeyer flask as the mately 18 inches long and made from 1/ evaporation proceeds. When the volume 16 inch outside diameter 316 stainless of the solvent has been reduced to steel welding rod or equivalent and about 50 milliliters, transfer the con- hooked at both ends, is used to position centrated liquid to a previously tared the basket in the extraction apparatus.
273
VerDate 06
(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 inch squares using clean sharp scissors. at least 12 determinations. Applica- Proceed with Option 1 or 2. tions of solvent reuse should be con- Option 1. Using tweezers and noting firmed for each resin type before use. the number of film pieces, transfer 2.5 grams (accurately weighed to 0.1 milli- (4) Maximum soluble fraction in xy- gram) of polymer to the extraction ves- lene—(i) Olefin copolymers described in sel. Extract the film sample for 2 paragraph (a)(3)(ii) of this section, poly- hours. Allow the vessel to cool and fil- propylene, and poly(methylpen-tene). A ter the contents through a fritted por- sample is dissolved completely in xy- celain funnel. Wash the film pieces lene by heating and stirring in a bottle with fresh n-hexane, aspirate to dry- with little free space. The solution is ness, and transfer, using tweezers, to a allowed to cool without stirring, beaker. Recount the film pieces to whereupon the insoluble portion pre- verify that none were lost during the cipitates and is filtered off; the total transfer. Place the beaker in the vacu- solids content of the filtrate is then de- um oven for 2 hours at 80 °C ±5 °C. After termined as a measure of the soluble 2 hours, remove and place in a desic- fraction. cator to cool to room temperature (a) Apparatus. (1) Pyrex (or equiva- (about 1 hour). After cooling, reweigh lent) reagent bottle, 125-milliliter, the film pieces to the nearest 0.1 milli- glass-stoppered. gram. Calculate the percent hexane- (2) Heating mantle of size for 150-mil- extractables content from the weight liliter beaker (or suitable aluminum loss of the original sample. Multiply block to fit the 125-milliter bottle de- the result by 0.935 and compare with scribed in paragraph (d)(4)(i)(a)(1) of extraction limits in paragraph (c) of this section.
274
VerDate 06
(3) Magnetic stirrer for use under the heat and allow it to cool 1 hour in the heating mantle (combination magnetic air, without stirring. Then place the stirrer and hotplate may be used if alu- bottle in a water bath maintained at 25 minum block is used in place of heat- °C ±0.5 °C, and allow to stand 1 hour ing mantle). without stirring. Next, remove the bot- (4) Variable-voltage transformer, 7.5 tle from the water bath, shake, and amperes. pour part of the contents into the (5) Tetrafluoroethylene-resin-coated coarse-porosity fritted-glass funnel. stirring bar, 1-inch long. Apply suction, and draw 30–40 milli- (6) Constant temperature water bath liters of filtrate through, adding more maintained at 25 °C±0.5 °C. slurry to the funnel, and catching the (7) Aluminum dishes, 18 millimeters × filtrate in a large test tube. (If the 60 millimeters, disposable. slurry is hard to filter, add 10 grams of (8) Funnel, Buchner type, with diatomaceous earth filter aid to the coarse-porosity fritted disc, 30–60 milli- bottle and shake vigorously just prior meter diameter. to the filtration.) Pipet a suitable ali- (b) Reagent. Xylene with antioxidant. quot (preferably 20 milliliters) of the Dissolve 0.020 gram of phenyl-β- naph- filtrate into a tared aluminum dispos- thylamine in 1 liter of industrial grade able dish. Place the dish on a steam xylene having specific gravity 0.856– bath covered with a fresh sheet of alu- 0.867 (20 °C/20 °C) and boiling range 123 minum foil and invert a short-stemmed °C–160 °C. 4-inch funnel over the dish. Pass nitro- (c) Procedure. Weigh 1 to 2 grams of gen (heated if desired) down through sample to the nearest 0.001 gram and the funnel at a rate sufficient to just place in a 125-milliliter Pyrex reagent ripple the surface of the solvent. When bottle containing a 1-inch long tetra- the liquid has evaporated, place the fluoroethylene-resin-coated stirring dish in a vacuum oven at 140 °C and bar. Add 100 milliliters of solvent, set less than 50 millimeters mercury pres- the stopper in lightly, and place the sure for 2 hours. Cool in a desiccator bottle in the heating mantle or alu- and weigh. (Note: If the residue value minum block maintained at a tempera- seems high, redry in the vacuum oven ture of 120 °C, and stir with a magnetic for one-half hour to ensure complete stirrer until the sample is completely removal of all xylene solvent.) Calcula- dissolved. Remove the bottle from the 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- controlled by a variable-voltage trans- graph (a)(3)(i) of this section and poly- former. ethylene. A sample is extracted in xy- (2) Constant temperature water bath. It lene at reflux temperature for 2 hours must be large enough to permit immer- and filtered. The filtrate is evaporated sion of the extraction kettle and set to and the total residue weighed as a maintain 25 °C ±0.1 °C. measure of soluble fraction. (3) Evaporating apparatus. Gas cover (a) Apparatus—(1) Extraction appa- consisting of a flat Pyrex crystallizing ratus. Two-liter, straight-walled Pyrex dish (190 millimeters × 100 millimeters) (or equivalent) resin kettles, fitted inverted to fit over a 1-liter beaker with ground-glass covers, are most con- with 8-millimeter gas inlet tube sealed venient for this purpose. The cover is through center and an outlet tube 1 equipped with a thermometer and an inch off center. The beaker with gas efficient reflux condenser. The kettle is cover is inserted in an electric heating fitted with an electric heating mantle mantle equipped with a variable-volt- of appropriate size and shape which is age transformer. The outlet tube is at- tached to an efficient condenser
275
VerDate 06
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- 4 containing less than 10 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 reflux condenser and apply full voltage rected toward the center of the dish. (115 volts) to the heating mantle. When Avoid any charring of the residue. the xylene starts to boil, reduce the Transfer the weighing dish to a vacu- voltage to a level just sufficient to um desiccator at room temperature maintain reflux. After refluxing for at and allow to remain under reduced least 2 hours, disconnect the power pressure for at least 12 hours (over- source to the mantle, remove the ket- night), after which determine the net tle, and allow to cool in air until the weight of the residue to the nearest temperature of the contents drops to 50 0.0001 gram. Correct the result for non- °C, after which the kettle may be rap- volatile solvent blank obtained by idly cooled to 25 °C–30 °C by immersing evaporating the equivalent amount of in a cold water bath. Transfer the ket- xylene under identical conditions. Cal- tle to a constant temperature bath set culate the weight of residue originally to maintain 25 °C ±0.1 °C, and allow to present in the total weight of solvent equilibrate for a least 1 hour (may be (840 grams), using the appropriate fac- left overnight if convenient). Break up tor based on the weight of filtrate any precipitated polymers that may evaporated. have formed, and decant the xylene so- (5) Viscosity average molecular weight lution successively through a fast filter olefin copolymers described in paragraphs paper and then through a fritted-glass (a)(3) (iii) and (iv) of this section. The filter into a tared 1-liter Erlenmeyer viscosity average molecular weight flask, collecting only the first 450 mil- shall be determined from the kine- liliters—500 milliliters of filtrate (any matic viscosity (using ASTM method attempt to collect more of the xylene D445–74, ‘‘Test for Kinematic Viscosity solution usually results in clogging the of Transparent and Opaque Liquids’’ filter and risking losses). Reweigh the (Revised 1974), which is incorporated by Erlenmeyer flask and calculate the reference; copies are available from weight of the filtrate obtained to the American Society for Testing and Ma- nearest 0.1 gram. Transfer the filtrate, terials (ASTM), 1916 Race Street, quantitatively, from the Erlenmeyer Philadelphia, PA 19103, or available for flask to the 1-liter beaker, insert the inspection at the Office of the Federal beaker in its heating mantle, add a Register, 800 North Capitol Street, glass-coated magnetic stirring bar, and NW., suite 700, Washington, DC 20408) of
276
VerDate 06
solutions of the copolymers in solvents scribed in paragraph (a)(3)(ii) of this and at temperatures as follows: section shall be determined by ASTM (i) Olefin polymers described in para- method D 1601–78, ‘‘Standard Test graph (a)(3)(iii) of this section in Method for Dilute Solution Viscosity decahydronaphthalene at 135 °C. of Ethylene Polymers,’’ which is incor- (ii) Olefin polymers described in porated by reference in accordance paragraph (a)(3)(iv) of this section in with 5 U.S.C. 552(a). The availability of tetrachloroethylene at 30 °C. this incorporation by reference is given (6) Mooney viscosity—olefin copolymers in paragraph (d)(1) of this section. described in paragraph (a)(3)(iii) of this (e) Olefin copolymers described in section. Mooney viscosity is determined paragraph (a)(3) (i) of this section and by ASTM method D1646–81, ‘‘Standard polyethylene, alone or in combination, Test Method for Rubber—Viscosity and may be subjected to irradiation bom- Vulcanization Characteristics (Mooney bardment from a source not to exceed Viscometer),’’ which is incorporated by 2.3 million volts intensity to cause mo- reference (the availability of this in- lecular crosslinking of the polymers to corporation by reference is given in impart desired properties, such as in- paragraph (d)(1) of this section), using creased strength and increased ability the large rotor at a temperature of 100 to shrink when exposed to heat. ° ° C, except that a temperature of 127 C (f) The olefin polymers identified in shall be used for those copolymers and complying with this section, when whose Mooney viscosity cannot be de- used as components of the food-contact ° termined at 100 C. The apparatus con- surface of any article that is the sub- taining the sample is warmed for 1 ject of a regulation in parts 174, 175, minute, run for 8 minutes, and vis- 176, 177, 178, and § 179.45 of this chapter, cosity measurements are then made. shall comply with any specifications (7) Melt flow index. The melt flow and limitations prescribed by such reg- index of olefin polymers described ulation for the article in the finished below shall be determined by ASTM form in which it is to contact food. method D–1238–82, ‘‘Standard Test (g) The provisions of this section are Method for Flow Rates of Thermo- not applicable to olefin polymers iden- plastics by Extrusion Plastometer,’’ tified in § 175.105(c) (5) of this chapter which is incorporated by reference in and used in food-packaging adhesives accordance with 5 U.S.C. 552(a). The complying with § 175.105 of this chapter. availability of this incorporation by reference is given in paragraph (d)(1) of [42 FR 14572, Mar. 15, 1977] this section. The olefin polymers and EDITORIAL NOTE: For FEDERAL REGISTER ci- test conditions and procedures are as tations affecting § 177.1520, see the List of follows: CFR Sections Affected in the Finding Aids section of this volume. List of polymers Conditions/procedures
Olefin copolymers described in para- Condition L, proce- § 177.1550 Perfluorocarbon resins. graph (a)(3)(i)(c)(2) of this section. dure A. Perfluorocarbon resins identified in Olefin copolymers described in para- Condition E, proce- graph (a)(3)(v) of this section. dure A. this section may be safely used as arti- cles or components of articles intended (8) Melting peak temperature. The melt to contact food, subject to the provi- temperature of the olefin polymers de- sions of this section: scribed in paragraph (a)(3)(ii) of this (a) Identity. For the purpose of this section shall be determined by ASTM section, perfluorocarbon resins are method D 3418–82, ‘‘Standard Test those produced by: (1) The Method for Transition Temperatures of homopolymerization and/or copolym- Polymers by Thermal Analysis,’’ which erization of hexafluoropropylene and is incorporated by reference in accord- tetrafluoroethylene, and (2) the co- ance with 5 U.S.C. 552(a). The avail- polymerization of ability of this incorporation by ref- perfluoropropylvinylether and tetra- erence is given in paragraph (d)(1) of fluoroethylene (CAS Reg. No. 26655–00– this section. 5). The resins shall meet the extrac- (9) Intrinsic viscosity. The intrinsic tives limitations in paragraph (d) of viscosity of the olefin polymers de- this section.
277
VerDate 06
(b) Optional components. The List of substances Limitations perfluorocarbon resins identified in Naphthalene sulfonic acid For use only: paragraph (a) of this section as well as formaldehyde condensate, 1. As a component of re- articles or coating made from these sodium salt. peated-use coatings, resins may include the following op- based on the perfluorocarbon resin tional components except that the identified in paragraph resin identified in paragraph (a)(2) of (a)(1) of this section, not this section may not be used with the to exceed 0.030 milli- meter (0.0012 inch) in optional component, lithium thickness, and at a level polysilicate, mentioned in paragraph not to exceed 0.4 weight (b)(4) of this section. percent of the coating. 2. As a component of re- (1) Substances generally recognized peated-use coatings, as safe (GRAS) in food or food pack- based on the perfluorocarbon resin aging subject to any limitations cited identified in paragraph on their use. (a)(2) of this section, not (2) Substances used in accordance to exceed 0.10 millimeter (0.004 inch) in thickness, with a prior sanction or approval, sub- and at a level not to ex- ject to any limitations cited in the ceed 0.4 weight percent prior sanction or approval. of the coating. (3) Substances authorized under ap- plicable regulations in this part and in (c) Optional processing. Poly- tetra- parts 175 and 178 of this chapter and fluoroethylene resins may be irradi- subject to any limitations prescribed ated by either a cobalt-60 sealed therein. source, at a maximum dose of gamma radiation not to exceed 7.5 megarads, (4) The following substances, subject or an electron beam at energy levels to any limitations prescribed: not to exceed 2.5 million electron volts List of substances Limitations with a maximum dosage of 7.5 megarads, to produce lubricant pow- Lithium polysilicate containing For use only as a compo- ders having a particle diameter of not not more than 20 weight per- nent of repeated-use cent silica, not more than 2.1 coatings not exceeding more than 20 microns for use only as percent lithium oxide and 0.030 millimeter (0.0012 components of articles intended for re- having a maximum mole inch) in thickness where peated use in contact with food. ratio of Si02/Li20 of 8.5 to 1. the coatings are thermally cured at minimum sinter- (d) Specifications—(1) Infrared identi- ing temperatures of 371 fication. Perfluorocarbon resins can be °C (700 °F). Lithium ex- tractives shall not exceed identified by their characteristic infra- 1.55 milligrams per red spectra. square decimeter (0.1 (2) Melt-viscosity. (i) The perfluoro- milligram per square inch) of coating surface when carbon resins identified in paragraph tested in accordance with (a)(1) of this section shall have a melt paragraph (e)(2) of this viscosity of not less than 104 poises at section. 380 °C (716 °F) as determined by ASTM method D1238–82, ‘‘Standard Test Meth- od for Flow Rates of Thermoplastics by Extrusion Plastometer,’’ which is in- corporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be ex- amined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. The melt viscosity of the perfluorocarbon resins identified in paragraph (a)(1) of this section shall not vary more than 50 percent within one-half hour at 380 °C (716 °F).
278
VerDate 06
(ii) Perfluorocarbon resins identified paragraph (e)(3) of this section when in paragraph (a)(2) of this section shall the resins in the form of coatings de- have a melt viscosity of not less than scribed in paragraphs (e)(2) (i) and (ii) 104 poises at 372 °C (702 °F) as deter- of this section are extracted at reflux mined by a more detailed method ti- temperatures for 2 hours separately tled ‘‘Determination of Melt Viscosity, with distilled water, 8 percent ethanol, Molecular Weight Distribution Index and n-heptane: and Viscosity Stability,’’ which is in- (i) Perfluorocarbon resin coatings corporated by reference. Copies are based on resins identified in paragraph available from the Center for Food (a)(1) of this section shall be applied to Safety and Applied Nutrition (HFS– both sides of a 0.025-millimeter (0.001 200), Food and Drug Administration, inch) thick aluminum foil to a thick- 200 C St. SW., Washington, DC 20204, or ness of 0.025 millimeter (0.001 inch) available for inspection at the Office of after thermal curing at 399 °C (750 °F) the Federal Register, 800 North Capitol for 10 minutes. If a primer is used, the Street, NW., suite 700, Washington, DC total thickness of the primer plus top- 20408. coat shall equal 0.025 millimeter (0.001 (3) Thermal instability index. The ther- inch) after heat curing. mal instability index of the tetra- (ii) Perfluorocarbon resin coatings fluoroethylene homopolymer shall not based on resins identified in paragraph exceed 50 as determined by ASTM (a)(2) of this section shall be applied to method D1457–56T, ‘‘Test for Thermal both sides of a 0.025-millimeter (0.001 Instablility index of Tetrafluoro- inch) thick aluminum foil to a thick- ethylene Homopolymer’’ (Revised 1956), ness of 0.10 millimeter (0.004 inch) after which is incorporated by reference. thermal curing at 427 °C (800 °F) for 10 Copies are available from University minutes. If a primer is used, the total Microfilms International, 300 N. Zeeb thickness of the primer plus topcoat Rd., Ann Arbor, MI 48106, or available shall equal 0.10 millimeter (0.004 inch) for inspection at the Office of the Fed- after heat curing. eral Register, 800 North Capitol Street, (3) The extracted surfaces shall meet NW., suite 700, Washington, DC 20408. the following extractability limits: The requirements of this paragraph do (i) Total extractives not to exceed 3.1 not apply to polytetrafluoroethylene 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 of 6.45 square decimeters (100 square per square inch). inches) or more and at least 1.27 milli- (f) Conditions of use. Perfluorocarbon meters (0.05 inch) thick shall be ex- resins identified in paragraph (a)(2) of tracted at reflux temperatures for 2 this section are limited to use as coat- hours separately with distilled water, ings or components of coatings for arti- 50 percent ethanol, n-heptane, and cles intended for repeated food-contact ethyl acetate. use. (2) Perfluorocarbon resins identified in paragraphs (a)(1) and (2) of this sec- [43 FR 44834, Sept. 29, 1978, as amended at 47 FR 11843, Mar. 19, 1982; 47 FR 14699, Apr. 6, tion and intended for use as coatings or 1982; 49 FR 10109, Mar. 19, 1984; 50 FR 1502, components of coatings shall meet Jan. 11, 1985; 54 FR 24898, June 12, 1989; 61 FR extractability limits prescribed in 14481, Apr. 2, 1996]
1 A more detailed procedure of extraction § 177.1555 Polyarylate resins. conditions is entitled, ‘‘Preparation of Ex- Polyarylate resins (CAS Reg. No. tracts,’’ which is incorporated by reference. 51706–10–6) may be safely used as arti- Copies are available from the Center for cles or components of articles intended Food Safety and Applied Nutrition (HFS– for use in contact with food in accord- 200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or available for ance with the following prescribed con- inspection at the Office of the Federal Reg- ditions: ister, 800 North Capitol Street, NW., suite (a) Identity. Polyarylate resins (1, 3- 700, Washington, DC 20408. benzenedicarboxylic acid, diphenyl
279
VerDate 06
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 (c) Extractive limitations. The finished minimum weight average molecular food-contact article yields net total ex- weight of 20,000. tractives in each extracting solvent (3) Polyarylate resins may be identi- not to exceed 0.052 milligram per fied by their characteristic infrared square inch (corresponding to 0.008 mil- spectra. ligram per square centimeter) of food- (c) Extractive limitations. The finished contact surface, when extracted at polyarylate resins in sheet form at reflux temperature for 2 hours with the least 0.5 millimeter (0.020 inch) thick, following solvents: Distilled water, 50 when extracted with water at 121 °C percent (by volume) ethyl alcohol in (250 °F) for 2 hours, shall yield total distilled water, 3 percent acetic acid nonvolatile extractives not to exceed (by weight) in distilled water, and n- 2.33 micrograms per square centimeter heptane. (15 micrograms per square inch) of the (d) In testing the finished food-con- exposed resin surface. tact article made of (d) Limitations. Polyarylate resin ar- polyaryletherketone resin, use a sepa- ticles may be used in contact with all rate test sample for each required ex- foods except beverages containing tracting solvent. more than 8 volume percent ethanol [61 FR 42381, Aug. 15, 1996] under conditions of use A through H, described in table 2 of § 176.170(c) of this § 177.1560 Polyarylsulfone resins. chapter. Polyarylsulfone resins (CAS Reg. No. [52 FR 35540, Sept. 22, 1987] 79293–56–4) may be safely used as arti- cles or components of articles intended § 177.1556 Polyaryletherketone resins. for use in contact with food, at tem- The poly(oxy-1,4-phenylenecarbonyl- peratures up to and including normal 1,4-phenyleneoxy-1,4- baking temperatures, in accordance phenylenecarbonyl-1,4- with the following prescribed condi- phenylenecarbonyl-1,4-phenylene) res- tions: ins (CAS Reg. No. 55088–54–5 and CAS (a) Identity. Polyarylsulfone resins Reg. No. 60015–05–6 and commonly re- are copolymers containing not more ferred to as polyaryletherketone res- than 25 percent of oxy-p-phenylene- ins) identified in paragraph (a) of this oxy-p-phenylenesulfonyl-p-phenylene section may be safely used as articles polymer units and not less than 75 per- or components of articles intended for cent of oxy-p-phenylenesulfonyl-p- repeated use in contact with food, sub- phenylene-oxy-p-phenylenesulfonyl-p- ject to the provisions of this section. phenylene polymer units. The copoly- (a) Identity. Polyaryletherketone res- mers have a minimum reduced vis- ins consist of basic resins produced by cosity of 0.40 deciliter per gram in 1- reacting 4,4′-diphenoxy benzophenone methyl-2-pyrrolidinone in accordance and terephthaloyl dichloride in such a with ASTM method D2857–70 (Re- way that the finished resins have a approved 1977), ‘‘Standard Test Method minimum weight average molecular for Dilute Solution Viscosity of Poly- weight of 20,000 grams per mole, as de- mers,’’ which is incorporated by ref- termined by light scattering measure- erence. Copies may be obtained from ments in sulfuric acid at room tem- the American Society for Testing and perature. Materials, 1916 Race St., Philadelphia,
280
VerDate 06
PA 19103, or may be examined at the polymer units derived from ethylene in Office of the Federal Register, 800 the copolymer. North Capitol Street, NW., suite 700, (b) Specifications and limitations. Poly- Washington, DC 20408. 1-butene resins and butene/ethylene co- (b) Optional adjuvant substances. The polymers shall conform to the speci- basic polyarylsulfone resins identified fications prescribed in paragraph (b)(1) in paragraph (a) of this section may of this section, and shall meet the contain optional adjuvant substances extractability limits prescribed in required in the production of such paragraph (b)(2) of this section. basic copolymers. These optional adju- (1) Specifications—(i) Infrared identi- vant substances may include sub- fication. Poly-1-butene resins and stances permitted for such use by regu- butene/ethylene copolymers can be lations in parts 170 through 179 of this identified by their characteristic infra- chapter, substances generally recog- red spectra. nized as safe in food, substances used in (ii) Viscosity. Poly-1-butene resins and accordance with a prior sanction of ap- the butene/ethylene copolymers have proval, and substances named in this an intrinsic viscosity 1.0 to 3.2 as deter- paragraph and further identified as re- mined by ASTM method D1601–78, quired: ‘‘Standard Test Method for Dilute So- lution Viscosity of Ethylene Poly- Substances Limitations mers,’’ which is incorporated by ref- Sulfolane ..... Not to exceed 0.15 percent as residual sol- erence. Copies may be obtained from vent in the finished basic resin. the American Society for Testing Ma- terials, 1916 Race St., Philadelphia, PA (c) Extractive limitations. The finished 19103, or may be examined at the Office polyarylsulfone resin when extracted of the Federal Register, 800 North Cap- for 2 hours with the following solvents itol Street, NW., suite 700, Washington, at the specified temperatures yields DC 20408. total extractives in each extracting (iii) Density. Poly-1-butene resins solvent not to exceed 0.008 milligram have a density of 0.904 to 0.920 gms/cm3, per square centimeter of food-contact and butene/ethylene copolymers have a surface: distilled water at 121 °C (250 density of 0.890 to 0.916 gms/cm3 as de- °F), 50 percent (by volume) ethyl alco- termined by ASTM method D1505–68 hol in distilled water at 71.1 °C (160 °F), (Reapproved 1979), ‘‘Standard Test 3 percent acetic acid in distilled water Method for Density of Plastics by the at 100 °C (212 °F), and n-heptane at 65.6 Density-Gradient Technique,’’ which is °C (150 °F). incorporated by reference. The avail- NOTE: In testing the finished polyaryl- ability of this incorporation by ref- sulfone resin use a separate test sample for erence is given in paragraph (b)(1)(ii) of each required extracting solvent. this section. [50 FR 31046, July 24, 1985] (iv) Melt index. Poly-1-butene resins have a melt index of 0.1 to 24 and the § 177.1570 Poly-1-butene resins and butene/ethylene copolymers have a butene/ethylene copolymers. melt index of 0.1 to 20 as determined by The poly-1-butene resins and butene/ ASTM method D1238–82, condition E, ethylene copolymers identified in this ‘‘Standard Test Method for Flow Rates section may be safely used as articles of Thermoplastics by Extrusion Plas- or components of articles intended for tometer,’’ which is incorporated by ref- use in contact with food subject to the erence. The availability of this incor- provisions of this section. poration by reference is given in para- (a) Identity. Poly-1-butene resins are graph (b)(1)(ii) of this section. produced by the catalytic polymeriza- (2) Limitations. Poly-1-butene resins tion of 1-butene liquid monomer. and butene/ethylene copolymers for use Butene/ethylene copolymers are pro- in articles that contact food, and for duced by the catalytic polymerization articles used for packing or holding of 1-butene liquid monomer in the pres- food during cooking shall yield no ence of small amounts of ethylene more than the following extractables: monomer so as to yield no higher than (i) Poly-1-butene resins may be used a 6-weight percent concentration of as articles or components of articles
281
VerDate 06
intended for use in contact with food, (3) The condensation of 4,4′-isopro- provided that the maximum pylidenediphenol, carbonyl chloride, extractables do not exceed 2.5 percent and 0.5 percent weight maximum of by weight of the polymer when film or a2,a6-bis (6-hydroxy-m-tolyl) mesitol to molded samples are tested for 2 hours which may have been added certain op- at 50 °C (122 °F) in n-heptane. tional adjuvant substances required in (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 millimeter (0.004 to 0.008 inch) in thick- List of substances Limitations ness do not exceed 0.80 percent by p-tert-Butylphenol ...... weight of the polymer when extracted Chloroform ...... in a soxhlet extractor for 6 hours with p-Cumylphenol (CAS Reg. For use only as a chain ter- No. 599±64±4). minator at a level not to ex- refluxing 95 percent ethanol. ceed 5 percent by weight (iii) Poly-1-butene resins may be used of the resin. as articles or components of articles Ethylene dichloride. intended for packaging or holding food Heptane. Methylene chloride. during cooking, provided that the Monochlorobenzene ...... Not to exceed 500 p.p.m. as thickness of such polymers in the form residual solvent in finished in which they contact food shall not resin. Pentaerythritol tetrastearate For use only as a mold re- exceed 0.1 millimeter (0.004 inch) and (CAS Reg. No. 115±83±3). lease agent, at a level not yield maximum extractables of not to exceed 0.5 percent by more than 2.5 percent by weight of the weight of the finished resin. polymer when films are extracted for 2 Phenol (CAS Reg. No. 108± 95±2). hours at 50 °C (122 °F) in n-heptane. Pyridine. Toluene: (CAS Reg. No. Not to exceed 800 parts per [42 FR 14572, Mar. 15, 1977, as amended at 49 108±88±3). million as residual solvent FR 10109, Mar. 19, 1984; 50 FR 31349, Aug. 2, in finished resin. 1985] Triethylamine.
§ 177.1580 Polycarbonate resins. (c) Polycarbonate resins shall con- Polycarbonate resins may be safely form to the specification prescribed in used as articles or components of arti- paragraph (c)(1) of this section and cles intended for use in producing, shall meet the extractives limitations manufacturing, packing, processing, prescribed in paragraph (c)(2) of this preparing, treating, packaging, trans- section. porting, or holding food, in accordance (1) Specification. Polycarbonate resins with the following prescribed condi- can be identified by their char- tions: acteristic infrared spectrum. (a) Polycarbonate resins are poly- (2) Extractives limitations. The esters produced by: polycarbonate resins to be tested shall (1) The condensation of 4,4′-iso- be ground or cut into small particles propylidenediphenol and carbonyl chlo- that will pass through a U.S. standard ride to which may have been added cer- sieve No. 6 and that will be held on a tain optional adjuvant substances re- U.S. standard sieve No. 10. quired in the production of the resins; (i) Polycarbonate resins, when ex- or by tracted with distilled water at reflux (2) The reaction of molten 4,4′-iso- temperature for 6 hours, shall yield propylidenediphenol with molten di- total extractives not to exceed 0.15 per- phenyl carbonate in the presence of the cent by weight of the resins. disodium salt of 4,4′-isopro- (ii) Polycarbonate resins, when ex- pylidenediphenol. tracted with 50 percent (by volume)
282
VerDate 06
ethyl alcohol in distilled water at (1) Specifications. Polyestercarbonate reflux temperature for 6 hours, shall resins identified in paragraph (a) of yield total extractives not to exceed this section can be identified by their 0.15 percent by weight of the resins. characteristic infrared spectrum. The (iii) Polycarbonate resins, when ex- solution intrinsic viscosity of the tracted with n-heptane at reflux tem- polyestercarbonate resins shall have a perature for 6 hours, shall yield total range of 0.50 to 0.58 deciliter per gram extractives not to exceed 0.15 percent as determined by a method titled, ‘‘In- by weight of the resins. trinsic Viscosity (IV) of Lexan [42 FR 14572, Mar. 15, 1977, as amended at 46 Polycarbonate Resin by a Single Point FR 23227, Apr. 24, 1981; 49 FR 4372, Feb. 6, Method Using Dichloromethane as the 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656, Solvent,’’ developed by the General Aug. 8, 1988; 59 FR 43731, Aug. 25, 1994] Electric Co., September 20, 1985, which is incorporated by reference in accord- § 177.1585 Polyestercarbonate resins. ance with 5 U.S.C. 552(a) and 1 CFR Polyestercarbonate resins may be part 51. Copies are available from the safely used as articles or components Center for Food Safety and Applied Nu- of articles intended for use in pro- trition (HFS–200), Food and Drug Ad- ducing, manufacturing, packing, proc- ministration, 200 C St. SW., Wash- essing, preparing, treating, packaging, ington, DC 20204, or may be examined or holding food, in accordance with the at the Office of the Federal Register, following prescribed conditions: 800 North Capitol Street, NW., suite (a) Polyestercarbonate resins (CAS 700, Washington, DC. Reg. No. 71519–80–7) are produced by the (2) Extractives limitations. The condensation of 4,4′-isopropyli- polyestercarbonate resins to be tested denediphenol, carbonyl chloride, shall be ground or cut into small par- terephthaloyl chloride, and ticles that will pass through a U.S. isophthaloyl chloride such that the res- standard sieve No. 6 and that will be ins are composed of 70 to 85 percent held on U.S. standard sieve No. 10. ester, of which up to 10 percent is the (i) Polyestercarbonate resins, when terephthaloyl isomer. The resins are extracted with distilled water at reflux manufactured using a phthaloyl chlo- temperature for 6 hours, shall yield ride/carbonyl chloride mole ratio of total nonvolatile extractives not to ex- 2.3–4.0/1 and an isophthaloyl chloride/ ceed 0.005 percent by weight of the res- terephthaloyl chloride mole ratio of ins. 9.0/1 or greater. (ii) Polyestercarbonate resins, when (b) Optional adjuvants. The optional extracted with 50 percent (by volume) adjuvant substances required in the ethyl alcohol in distilled water at production of resins identified in para- reflux temperature for 6 hours, shall graph (a) of this section may include: yield total nonvolatile extractives not (1) Substances used in accordance to exceed 0.005 percent by weight of the with § 174.5 of this chapter. resins. (2) Substances identified in (iii) Polyestercarbonate resins, when § 177.1580(b). extracted with n-heptane at reflux (3) Substances regulated in temperature for 6 hours, shall yield § 178.2010(b) of this chapter for use in total nonvolatile extractives not to ex- polycarbonate resins complying with ceed 0.002 percent by weight of the res- § 177.1580: ins. Provided, That the substances are used (3) Residual methylene chloride levels in in accordance with any limitation on polyestercarbonate resins. Polyester- concentration, conditions of use, and carbonate resin articles in the finished food types specified in § 178.2010(b) of form shall not contain residual meth- this chapter. ylene chloride in excess of 5 parts per (c) Polyestercarbonate resins shall million as determined by a method ti- conform to the specifications pre- tled ‘‘Analytical Method for Deter- scribed in paragraph (c)(1) of this sec- mination of Residual Methylene Chlo- tion and shall meet the extractive lim- ride in Polyestercarbonate Resin,’’ de- itations prescribed in paragraph (c)(2) veloped by the General Electric Co., of this section. July 23, 1991, which is incorporated by
283
VerDate 06
reference in accordance with 5 U.S.C. NW., suite 700, Washington, DC 20408), 552(a) and 1 CFR part 51. Copies are using No. 50 emery abrasive in lieu of available from the Center for Food Ottawa sand, shall exhibit an abrasion Safety and Applied Nutrition (HFS– coefficient of not less than 100 liters 200), Food and Drug Administration, per mil of thickness. 200 C St. SW., Washington, DC 20204, or [42 FR 14572, Mar. 15, 1977, as amended at 49 may be examined at the Office of the FR 10109, Mar. 19, 1984] Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC. § 177.1595 Polyetherimide resin. [57 FR 3940, Feb. 3, 1992] 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- chapter, table 1, under Type VIII, in ac- ethylidene)bis(4,1-phenyleneoxy)] bis- cordance with the following prescribed polymer with 1,3-benzenediamine (CAS conditions: Reg. No. 61128–46–9), and is derived from (a) For the purpose of this section, the condensation reaction of m- phenylenediamine and bisphenol A- polyester elastomers are those pro- dianhydride. duced by the ester exchange reaction (b) Optional adjuvants. The basic when one or more of the following polymer identified in paragraph (a) of phthalates—dimethyl terephthalate, this section may contain optional adju- dimethyl orthophthalate, and dimethyl vant substances required in the produc- isophthalate—is made to react with tion of basic resins or finished food- alpha-hydroomega-hydroxypoly contact articles. The optional adjuvant (oxytetramethylene) and/or 1,4- substances required in the production butanediol such that the finished elas- of the basic polymer may include sub- tomer has a number average molecular stances permitted for such use by ap- weight between 20,000 and 30,000. plicable regulations as set forth in part (b) Optional adjuvant substances em- 174 of this chapter. ployed in the production of the poly- (c) Specifications and extractives limi- ester elastomers or added thereto to tations—(1) Specifications. impart desired technical or physical Polyetherimide resin identified in properties may include the following paragraph (a) of this section shall have substances: an intrinsic viscosity in chloroform at List of substances Limitations 25 °C (77 °F) of not less than 0.35 deci- liter per gram as determined by a 4,4′ - Bis (alpha, alpha-di- For use only as an anti- method titled ‘‘Intrinsic Viscosity of methyl-benzyl) oxidant. diphenylamine. ULTEM Polyetherimide Using Chloro- Tetrabutyl titanate ...... For use only as a catalyst. form as the Solvent,’’ which is incor- porated by reference. Copies are avail- (c) An appropriate sample of the fin- able from the Center for Food Safety ished polyester elastomer in the form and Applied Nutrition (HFS–200), Food in which it contacts food when sub- and Drug Administration, 200 C St. jected to ASTM method D968–81, SW., Washington, DC 20204, or available ‘‘Standard Test Methods for Abrasion for inspection at the Office of the Fed- Resistance of Organic Coatings by the eral Register, 800 North Capitol Street, Falling Abrasive Tester,’’ which is in- NW., suite 700, Washington, DC 20408. corporated by reference (copies may be (2) Extractive limitations. Extractive obtained from the American Society limitations are applicable to the basic for Testing Materials, 1916 Race St., polyetherimide resin in the form of Philadelphia, PA 19103, or may be ex- molded discs of thickness 0.16 centi- amined at the Office of the Federal meter (0.063 inch). The resin discs when Register, 800 North Capitol Street, extracted with distilled water at 121 °C
284
VerDate 06
(250 °F) for 2 hours yield total nonvola- § 177.1610 Polyethylene, chlorinated. tile extractives of not more than 12.3 Chlorinated polyethylene identified micrograms per square centimeter. in this section may be safely used as [50 FR 31351, Aug. 2, 1985; 50 FR 35535, Sept. articles or components of articles that 3, 1985] contact food, except for articles used for packing or holding food during § 177.1600 Polyethylene resins, cooking, subject to the provisions of carboxyl modified. this section. Carboxyl-modified polyethylene res- (a) For the purpose of this section, ins may be safely used as the food-con- chlorinated polyethylene consists of tact surface of articles intended for use basic polymers produced by the direct in contact with food in accordance chlorination of polyethylene con- with the following prescribed condi- forming to the density, maximum n- tions: hexane extractable fraction, and max- (a) For the purpose of this section, imum xylene soluble fraction specifica- carboxyl-modified polyethylene resins tions prescribed under item 2.1 of the consist of basic polymers produced table in § 177.1520(c). Such chlorinated when ethylene-methyl acrylate basic polyethylene contains a maximum of 60 copolymers, containing no more than percent by weight of total chlorine, as 25 weight percent of polymer units de- determined by ASTM method D1303–55 rived from methyl acrylate, are made (Reapproved 1979), ‘‘Standard Test to react in an aqueous medium with Method for Total Chlorine in Vinyl one or more of the following sub- Chloride Polymers and Copolymers,’’ stances: which is incorporated by reference (copies may be obtained from the Ammonium hydroxide. American Society for Testing Mate- Calcium carbonate. rials, 1916 Race St., Philadelphia, PA Potassium hydroxide. 19103, or may be examined at the Office Sodium hydroxide. of the Federal Register, 800 North Cap- (b) The finished food-contact article, itol Street, NW., suite 700, Washington, when extracted with the solvent or sol- DC 20408), and has a 7.0 percent max- vents characterizing the type of food imum extractable fraction in n-hexane and under the conditions of time and at 50 °C, as determined by the method temperature characterizing the condi- described in § 177.1520(d)(3)(ii). tions of its intended use as determined (b) Chlorinated polyethylene may be from tables 1 and 2 of § 176.170(c) of this used in contact with all types of food, chapter, yields total extractives in except that when used in contact with each extracting solvent not to exceed fatty food of Types III, IV–A, V, VII–A, 0.5 milligram per square inch of food- and IX described in table 1 of § 176.170(c) contact surface as determined by the of this chapter, chlorinated poly- methods described in § 176.170(d) of this ethylene is limited to use only as a chapter; and if the finished food-con- modifier admixed at levels not exceed- tact article is itself the subject of a ing 15 weight percent in plastic articles regulation in parts 174, 175, 176, 177, 178, prepared from polyvinyl chloride and/ and § 179.45 of this chapter, it shall also or from vinyl chloride copolymers com- comply with any specifications and plying with § 177.1980. limitations prescribed for it by that [42 FR 14572, Mar. 15, 1977, as amended at 49 regulation. In testing the finished food- FR 10109, Mar. 19, 1984; 59 FR 14550, Mar. 29, contact articles, a separate test sample 1994] is to be used for each required extract- ing solvent. § 177.1615 Polyethylene, fluorinated. (c) The provisions of paragraph (b) of Fluorinated polyethylene, identified this section are not applicable to in paragraph (a) of this section, may be carboxyl-modified polyethylene resins safely used as food-contact articles in used in food-packaging adhesives com- accordance with the following pre- plying with § 175.105 of this chapter. scribed conditions:
285
VerDate 06
(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 tables 1 and 2 of § 176.170(c) of this chap- are not applicable to oxidized poly- ter, yields fluoride ion not to exceed 5 ethylene used as provided in §§ 175.125 parts per million calculated on the and 176.170(a)(5) of this chapter and basis of the volume of food held by the § 177.1200. food-contact article. [48 FR 39057, Aug. 29, 1983] § 177.1630 Polyethylene phthalate polymers. § 177.1620 Polyethylene, oxidized. Polyethylene phthalate polymers Oxidized polyethylene identified in identified in this section may be safely paragraph (a) of this section may be used as, or components of plastics safely used as a component of food-con- (films, articles, or fabric) intended for tact articles, in accordance with the use in contact with food in accordance following prescribed conditions: with the following prescribed condi- (a) Oxidized polyethylene is the basic tions: resin produced by the mild air oxida- (a) Polyethylene phthalate films con- tion of polyethylene conforming to the sist of a base sheet of ethylene density, maximum n-hexane extract- terephthalate polymer, ethylene able fraction, and maximum xylene terephthalate-isophthalate copolymer, soluble fraction specifications pre- or ethylene-1,4-cyclohexylene scribed under item 2.3 of the table in dimethylene terephthalate copoly- § 177.1520(c). Such oxidized polyethylene esters described in § 177.1315(b)(3), to has a minimum number average molec- which have been added optional sub- ular weight of 1,200, as determined by stances, either as constituents of the high temperature vapor pressure os- base sheet or as constituents of coat- mometry, contains a maximum of 5 ings applied to the base sheet. percent by weight of total oxygen, and (b) Polyethylene phthalate articles has an acid value of 9 to 19. consist of a base polymer of ethylene (b) The finished food-contact article, terephthalate polymer, or ethylene-1,4- when extracted with the solvent or sol- cyclohexylene dimethylene vents characterizing the type of food terephthalate copolyesters described in and under the conditions of time and § 177.1315(b)(3), to which have been temperature characterizing the condi- added optional substances, either as tions of its intended use as determined constituents of the base polymer or as from tables 1 and 2 of § 176.170(c) of this constituents of coatings applied to the chapter, yields net acidified chloro- base polymer.
286
VerDate 06
(c)(1) Polyethylene phthalate of the following: Azelaic acid, dimethyl spunbonded nonwoven fabric consist of azelate, dimethyl sebacate, sebacic acid. continuous filaments of ethylene Ethylene terephthalate copolymers: Pre- terephthalate polymer and ethylene pared by the condensation of dimethyl terephthalate or terephthalic acid with terephthalate-isophthalate copolymer ethylene glycol, modified with one or more to which may have been added optional of the following: Azelaic acid, dimethyl adjuvant substances required in their azelate, dimethyl sebacate, sebacic acid, preparation and finishing. pyromellitic dianhydride. The level of (2) The ethylene terephthalate- pyromellitic dianhydride shall not exceed isophthalate copolymer component of 0.5 percent by weight of the finished co- the fabric shall not exceed 25 percent polymer which may be used under condi- tions of use E through H as described in by weight. The filaments may be blend- table 2 of § 176.170(c) of this chapter. ed with other fibers regulated for the Ethylene terephthalate-isophthalate copoly- specific use and the spunbonded fabric mers: Prepared by the condensation of di- may be further bonded by application methyl terephthalate or terephthalic acid of heat and/or pressure. and dimethyl isophthalate or isophthalic (3) The fabric shall be used only in acid with ethylene glycol. The finished co- accordance with paragraph (i) of this polymers contain either: (a) 77 to 83 weight percent or section. (b) At least 97 weight percent of polymer (d) The quantity of any optional sub- units derived from ethylene stance employed in the production of terephthalate. polyethylene phthalate plastics does (ii) Base sheet and base polymer: not exceed the amount reasonably re- Ethylene-1,4-cyclohexylene dimethylene quired to accomplish the intended terephthalate copolyesters described in physical or technical effect or any lim- § 177.1315(b)(3). itations further provided. Any sub- Ethylene terephthalate polymer: Prepared stance employed in the production of by the condensation of dimethyl polyethylene phthalate plastics that is terephthalate and ethylene glycol. the subject of a regulation in parts 174, Ethylene terephthalate polymer: Prepared 175, 176, 177, 178 and 179 of this chapter by the condensation of terephthalic acid and ethylene glycol. conforms with any specification in such regulation. (iii) Coatings: (e) Substances employed in the pro- Acrylic copolymers (CAS Reg. No. 30394–86– duction of polyethylene phthalate plas- 6): Prepared by reaction of ethyl acrylate tics include: (CAS Reg. No. 140–88–5), methyl methacry- late (CAS Reg. No. 80–62–6), and (1) Substances generally recognized methacrylamide (CAS Reg. No. 79–39–0) as safe in food. blended with melamine-formaldehyde resin (2) Substances subject to prior sanc- (CAS Reg. No. 68002–20–0). For use in coat- tion or approval for use in poly- ings for polyethylene phthalate films com- ethylene phthalate plastics and used in plying with paragraph (a) of this section.– accordance with such sanction or ap- Ethylene azelate-terephthalate copolymer: proval. The copolymer, dissolved in 1,1,2-trichloro- ethane and/or methylene chloride, may be (3) Substances which by regulation in used as a heat-activated sealant on poly- parts 174, 175, 176, 177, 178 and § 179.45 of ethylene terephthalate film intended for this chapter may be safely used as sealing polyethylene terephthalate pouch- components of resinous or polymeric es that are used as containers of either food-contact surfaces subject to the nonalcoholic beverages or alcoholic bev- provisions of such regulation. erages containing not more than 15 percent ethyl alcohol. The copolymer has a (4) Substances identified in this para- terephthalate/azelate molecular ratio of graph (e)(4) subject to the limitations 1.25/1.00 and a relative viscosity of not less prescribed: than 1.5 as determined by a method title ‘‘General Procedure of Determining the LIST OF SUBSTANCES AND LIMITATIONS Relative Viscosity of Resin Polymers,’’ which is incorporated by reference. Copies (i) Base sheet: are available from the Center for Food Ethylene terephthalate copolymers: Pre- Safety and Applied Nutrition (HFS–200), pared by the condensation of dimethyl Food and Drug Administration, 200 C St. terephthalate or terephthalic acid with SW., Washington, DC 20204, or available for ethylene glycol, modified with one or more inspection, at the Office of the Federal
287
VerDate 06
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 plying with paragraph (a) of this section, weight of the polyethylene at levels not to exceed 0.025 gram per terephthalate. square meter (0.016 milligram per square Chloroform-soluble extractives shall not inch) of the film, in contact with food of exceed 0.08 milligram/centimeter 2 (0.5 types VIII and IX in table 1 of § 176.170(c) of milligram/inch 2) of food-contact surface this chapter, under use conditions E, F, of the modified polyethylene and G in table 2 of § 176.170(c) of this chap- terephthalate article when exposed to ter. the following solvents at temperatures and times indicated: (iv) Emulsifiers: (a) Distilled water at 49 °C (120 °F) for 24 Sodium dodecylbenzenesulfonate: As an ad- hours; juvant in the application of coatings to the (b) n-Heptane at 49 °C (120 °F) for 24 hours; base sheet or base polymer. (c) 8 percent ethyl alcohol at 49 °C (120 °F) Sodium lauryl sulfate: As an adjuvant in the for 24 hours. application of coatings to the base sheet or For use in contact with all types of foods base polymer. except (a) those containing more than 8 2-Sulfoethyl methacrylate, sodium salt (CAS percent alcohol, or (b) those at tempera- Reg. No. 1804–87–1). For use only in copoly- tures over 49 °C (120 °F). mer coatings on polyethylene phthalate film under conditions of use E, F, and G de- (f) Polyethylene phthalate plastics scribed in table 2 of § 175.300(d) of this chap- conforming with the specifications pre- ter, and limited to use at a level not to ex- scribed in paragraph (f)(1) of this sec- ceed 2.0 percent by weight of the dry co- tion are used as provided in paragraph polymer coating. (f)(2) of this section: (v) Modifier: (1) Specifications. (i) The food contact 1,4-Benzenedicarboxylic acid, dimethyl ester, surface, when exposed to distilled polymer with 1,4-butanediol and α-hydro- water at 250 °F for 2 hours, yields chlo- omega-hydroxypoly(oxy-1,4-butanediyl) roform-soluble extractives not to ex- CAS Reg. No. 9078–71–1) meeting the fol- ceed 0.5 mg/in 2 of food contact surface lowing specifications: exposed to the solvent; and Melting point: 200° to 215 °C as determined (ii) The food contact surface, when by ASTM method D2117–82, ‘‘Standard exposed to n-heptane at 150 °F for 2 Test Method for Melting Point of Semicrystalline Polymers by the Hot hours, yields chloroform-soluble ex- Stage Microscopy Method,’’ which is in- tractives not to exceed 0.5 mg/in 2 of corporated by reference. Copies may be food contact surface exposed to the sol- obtained from the American Society for vent.
288
VerDate 06
(2) Conditions of use. The plastics are (i) Distilled water at 212 °F for 2 used for packaging, transporting, or hours. holding food, excluding alcoholic bev- (ii) n-Heptane at 150 °F for 2 hours. erages, at temperatures not to exceed (iii) 50 percent ethyl alcohol at 120 °F 250 °F. for 24 hours. (g) Polyethylene phthalate plastics (2) Conditions of use. The plastics are conforming with the specifications pre- intended for: scribed in paragraph (g)(1) of this sec- (i) Dry food contact. tion are used as provided in paragraph (g)(2) of this section. (ii) Bulk food (excluding alcoholic (1) Specifications. (i) The food contact beverages) repeated use applications, surface meets the specifications in including filtration, at temperatures ° paragraph (f)(1) of this section; and not exceeding 212 F. (ii) The food contact surface when ex- (iii) Filtration of bulk alcoholic bev- posed to 50 percent ethyl alcohol at 120 erages, not exceeding 50 percent alco- °F for 24 hours, yields chloroform-solu- hol by volume, at temperatures not ex- ble extractives not to exceed 0.5 mg/in 2 ceeding 120 °F. of food contact surface exposed to the (j) Polyethylene phthalate plastics, solvent. composed of ethylene terephthalate- (2) Conditions of use. The plastics are isophthalate containing a minimum of used for packaging, transporting, or 98 weight percent of polymer units de- holding alcoholic beverages that do not rived from ethylene terephthalate, or exceed 50 percent alcohol by volume. ethylene-1,4-cyclohexylene (h) Uncoated polyethylene phthalate dimethylene terephthalate copoly- plastics consisting of a base sheet or esters described in § 177.1315(b)(3), con- base polymer prepared as prescribed forming with the specifications pre- from substances identified in para- scribed in paragraph (j)(1) of this sec- graphs (e)(4)(i) and (ii) of this section tion, are used as provided in paragraph and conforming with the specifications (j)(2) of this section. prescribed in paragraph (h)(1) of this (1) Specifications. (i) The food contact section are used as provided in para- surface meets the specifications in graph (h)(2) of this section: paragraph (f)(1) of this section and (1) Specifications. (i) The food contact (ii)( ) surface, when exposed to distilled a Containers with greater than 500 water at 250 °F for 2 hours yields chlo- mL capacity. The food-contact surface roform-soluble extractives not to ex- when exposed to 95 percent ethanol at ° ceed 0.02 milligram/inch 2 of food con- 120 F for 24 hours should not yield tact surface exposed to the solvent; and chloroform-soluble extractives in ex- (ii) The food contact surface, when cess of 0.005 mg/in 2. exposed to n-heptane at 150 °F for 2 (b) Containers with less than or equal to hours, yields chloroform-soluble ex- 500 mL capacity. The food contact sur- tractives not to exceed 0.02 milligram/ face when exposed to 95 percent eth- inch 2 of food contact surface exposed anol at 120 °F for 24 hours should not to the solvent. yield chloroform-soluble extractives in (2) Conditions of use. The plastics are excess of 0.05 mg/in 2. used to contain foods during oven bak- (2) Conditions of use. The plastics are ing or oven cooking at temperatures used for packaging, transporting, or above 250 °F. holding alcoholic foods that do not ex- (i) Polyethylene phthalate fabric, ceed 95 percent alcohol by volume. identified in paragraph (c) of this sec- tion and conforming with the specifica- [42 FR 14572, Mar. 15, 1977, as amended at 42 tions prescribed in paragraph (i)(1) of FR 18611, Apr. 8, 1977; 44 FR 40886, July 13, this section, is used only as provided in 1979; 45 FR 6541, Jan. 29, 1980; 47 FR 11844, Mar. 19, 1982; 47 FR 53346, Nov. 26, 1982; 48 FR paragraph (i)(2) of this section. 30361, July 1, 1983; 49 FR 10110, Mar. 19, 1984; (1) Specifications. Chloroform-soluble 50 FR 31047, July 24, 1985; 51 FR 3772, Jan. 30, extractives shall not exceed 0.2 milli- 1986; 52 FR 32917, Sept. 1, 1987; 54 FR 15750, gram/inch 2 of food-contact surface Apr. 19, 1989; 54 FR 24898, June 12, 1989; 60 FR when exposed to the following solvents 57927, Nov. 24, 1995; 60 FR 61654, Dec. 1, 1995; at temperatures and times indicated: 61 FR 46718, Sept. 5, 1996]
289
VerDate 06
§ 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 (1) Optional adjuvant substances au- gram/liter of tetrasodium thorized for this use in accordance with pyrophosphate and 0.5 percent deter- ° § 174.5 of this chapter. gent. The items are agitated at 80 C ° (2) Optional finish components, total (180 F) for 20 minutes, and then sub- weight not to exceed 1 percent by jected to a cold water rinse. weight of the base polymer, as follows: (2) Poly(phenyleneterephthalamide) resins in the form of pulp may be used List of substances Limitations as gaskets and packing for food proc- essing equipment at temperatures not Diundecylphthalate (CAS Reg. No. 3648±20±2). to exceed 260 °C (500 °F). Mono- and dipotassium salts of lauryl phosphate (CAS [57 FR 3125, Jan. 28, 1992] Reg. No. 39322±78±6). o-Phenylphenol (CAS Reg. For use as a fungicide for fin- § 177.1635 Poly(p-methylstyrene) and No. 90±43±7). ish coating materials. Not rubber-modified poly(p-methyl- to exceed 0.01 percent by styrene). weight of the base poly- mer. Poly(p-methylstyrene) and rubber- Poly(oxyethylene/ modified poly(p-methylstyrene) identi- oxypropylen- fied in this section may be safely used e)monobutylether (CAS Reg. No. 9038±95±3). as components of articles intended for Poly(oxyethylene) use in contact with food, subject to the mono(nonylphenyl)ether provisions of this section: (CAS Reg. No. 9019±45± 9). (a) Identity. For the purposes of this Polyvinyl methylether (CAS section, poly(p-methylstyrene) and Reg. No. 9003±09±2). rubber-modified poly(p-methylstyrene) Poly(oxyethylene) sorbitol monolaurate tetraoleate are basic polymers, manufactured as (CAS Reg. No. 71243±28± described in this paragraph, meeting 2). the specifications prescribed in para- Poly(oxyethylene) sorbitol graph (c) of this section. hexaoleate (CAS Reg. No. 57171±56±9). (1) Poly(p-methylstyrene) (CAS Reg. 4,4′-Butylidenebis (6-tert- For use only as an oxidation No. 24936–41–2) polymer produced by the butyl-m-cresol) (CAS Reg. inhibitor for finish coating polymerization of p-methylstyrene. No. 85±60±9). materials. Not to exceed 0.01 percent by weight of (2) Rubber-modified poly(p- the base polymer. methylstyrene) (CAS Reg. No. 33520–88– 6) polymer produced by combining sty- (c) Specifications. (1) rene-butadiene copolymer and/or Poly(phenyleneterephthalamide) resins polybutadiene with poly(p-
290
VerDate 06
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: shall contain not more than 1 weight (a) Identity. For the purpose of this percent of total residual p- section, poly(oxy-1,2- methystyrene monomer, as determined ethanediyloxycarbonyl-2,6- by a gas chromatographic method ti- naphthalenediylcarbonyl) resins (CAS tled, ‘‘Gas Chromatographic Deter- Reg. No. 24968–11–4) are polymers mination of PMS and PET in PPMS formed by catalytic transesterification Basic Polymers,’’ which is incorporated of 2,6-dimethylnaphthalene by reference. Copies are available from dicarboxylate with ethylene glycol fol- the Center for Food Safety and Applied lowed by catalytic polycondensation. Nutrition (HFS–200), Food and Drug (b) Specifications—(1) Density. The Administration, 200 C St. SW., Wash- density of poly(oxy-1,2- ington, DC 20204, or available for in- ethanediyloxycarbonyl-2,6- spection at the Office of the Federal naphthalenediylcarbonyl) resins shall Register, 800 North Capitol Street, be between 1.33 and 1.40 grams per NW., suite 700, Washington, DC 20408. cubic centimeter. (2) Rubber-modified poly(p- (2) Inherent viscosity. The finished methylstyrene) basic polymers identi- food-contact article shall have a min- fied in paragraph (a)(2) of this section imum inherent viscosity of 0.55 deci- shall contain not more than 0.5 weight liter per gram in a solution of 0.1 gram percent of total residual p- of polymer in 100 milliliters of a 25/40/ methylstyrene monomer, as deter- 35 (weight/weight/weight) solution of p- mined by the method identified in chlorophenol/tetrachloroethane/phenol. paragraph (c)(1) of this section The viscosity is determined by East- (d) Other specifications and limitations. man Chemical Co.’s method ECD-A-AC- The poly(p-methylstyrene) and rubber- G-V-1-5, ‘‘Determination of Dilute So- modified poly(p-methylstyrene) identi- lution Viscosity of Polyesters,’’ dated fied in and complying with this sec- May 31, 1988, which is incorporated by tion, when used as components of the reference in accordance with 5 U.S.C. food-contact surface of any article that 552(a) and 1 CFR part 51. Copies are is the subject of a regulation in parts available from the Office of Premarket 175, 176, 177, 178 and § 179.45 of this chap- Approval, Center for Food Safety and ter, shall comply with any specifica- Applied Nutrition (HFS–215), Food and tions and limitations prescribed by Drug Administration, 200 C St. SW., such regulation for the article in the Washington, DC 20204, or may be exam- finished form in which it is to contact ined at the Center for Food Safety and food. Applied Nutrition’s Library, Food and
291
VerDate 06
Drug Administration, 200 C St. SW., polymer units derived from styrene rm. 3321, Washington, DC, or at the Of- monomer. fice of the Federal Register, 800 North (b) Optional adjuvants. The basic Capitol St. NW., Washington, DC. polymers identified in paragraph (a) of (c) Extraction limitations. A 0.5 milli- this section may contain optional adju- meter (0.02 inch) thick sheet of resin vant substances required in the produc- when extracted with water at 121 °C tion of such basic polymers. Such op- (250 °F) for 2 hours shall yield total tional adjuvant substances may in- nonvolatile extractives not exceeding clude substances permitted for such 2.0 micrograms per square inch of ex- use by regulations in parts 170 through posed resin surface. 189 of this chapter, substances gen- (d) Conditions of use. The finished erally recognized as safe in food, and food contact article shall be: substances used in accordance with a (1) Used in contact only with food of prior sanction or approval. Types I, II, IVB, VIA, VIB, VIIB, and (c) Specifications. (1) Polystyrene VIII identified in table 1 of § 176.170(c) basic polymers identified in paragraph of this chapter, under conditions of use (a)(1) of this section shall contain not A through H described in table 2 of more than 1 weight percent of total re- § 176.170(c) of this chapter; and with sidual styrene monomer, as determined food of Types III, IVA, V, VIC, VIIA, by the method described in paragraph and IX identified in table 1 of (d) of this section, except that when § 176.170(c) of this chapter, under condi- used in contact with fatty foods of tions of use C through H described in Types III, IV-A, V, VII-A, and IX de- table 2 of § 176.170(c) of this chapter; scribed in table 1 of § 176.170(c) of this and chapter, such polystyrene basic poly- (2) Identified in a manner that will mers shall contain not more than 0.5 differentiate the article from articles weight percent of total residual sty- made of other polymeric resins to fa- rene monomer. cilitate collection and sorting. (2) Rubber-modified polystyrene [61 FR 14965, Apr. 4, 1996] basic polymers identified in paragraph (a)(2) of this section shall contain not § 177.1640 Polystyrene and rubber- more than 0.5 weight percent of total modified polystyrene. residual styrene monomer, as deter- Polystyrene and rubber-modified pol- mined by the method described in para- ystyrene identified in this section may graph (d) of this section. be safely used as components of arti- (d) Analytical method for determination cles intended for use in contact with of total residual styrene monomer con- food, subject to the provisions of this tent—(1) Scope. This method is suitable section. for the determination of residual sty- (a) Identity. For the purposes of this rene monomer in all types of styrene section, polystyrene and rubber-modi- polymers. fied polystyrene are basic polymers (2) Principle. The sample is dissolved manufactured as described in this para- in methylene chloride. An aliquot of graph so as to meet the specifications the solution is injected into a gas chro- prescribed in paragraph (c) of this sec- matograph. The amount of styrene tion when tested by the method de- monomer present is determined from scribed in paragraph (d) of this section. the area of the resulting peak. (1) Polystyrene consists of basic poly- (3) Apparatus—(i) Gas chromatograph. mers produced by the polymerization Beckman GC-2A gas chromatograph of styrene. with hydrogen flame detector or appa- (2) Rubber-modified polystyrene con- ratus of equivalent sensitivity. sists of basic polymers produced by (ii) Chromatograph column. One-quar- combining styrene-butadiene copoly- ter inch outside diameter stainless mers and/or polybutadiene with poly- steel tubing (0.028 inch wall thickness), styrene, either during or after polym- 4 feet in length, packed with 20 percent erization of the polystyrene, such that polyethylene glycol (20,000 molecular the finished basic polymers contain not weight) on alkaline treated 60–80 mesh less than 75 weight percent of total firebrick.
292
VerDate 06
(iii) Recorder. Millivolt range of 0–1, 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: (ii) By means of a microliter syringe, (a) Polysulfide polymer-polyepoxy inject 1 microliter of the standard solu- resins are the reaction products of liq- tion into the gas chromatograph. Meas- uid polysulfide polymers and ure the area of the styrene monomer polyfunctional epoxide resins, cured peak which emerges after approxi- with the aid of mately 12 minutes. tri(dimethylaminomethyl) phenol, to (7) (i) Transfer 1 gram of Procedure. which have been added certain optional sample (accurately weighed to the substances to impart desired techno- nearest 0.001 gram to a 2-ounce bottle logical properties to the resins. Subject and add several glass beads. Pipette to any limitations prescribed in this 25.0 milliliters of methylene chloride section, the optional substances may into the bottle. Cap the bottle tightly include: and place on a mechanical shaker. (1) Substances generally recognized Shake until the polymer is completely as safe in food and food packaging. dissolved. If any insoluble residue re- (2) Substances the use of which is mains, allow the bottle to stand (or permitted under applicable regulations centrifuge at a low speed) until a clear in this part, prior sanctions, or approv- supernatant layer appears. als. (ii) By means of a microliter syringe, (3) Substances named in this subpara- inject 3 microliters of the clear super- graph and further identified as re- natant liquid into the gas chro- quired: matograph. (iii) Measure the area of the resulting List of substances Limitations styrene monomer peak. Compare the sample peak area with the area pro- Bis(2-chloroethyl) formal. Bis(dichloropropyl) formal ...... Cross-linking agent. duced by the standard styrene mon- Butyl alcohol ...... Solvent. omer solution. Calculation: Carbon black (channel process). Chlorinated paraffins ...... Cross-linking agent. Percent residual styrene mon- Epoxidized linseed oil. omer=Milligrams monomer in stand- Epoxidized soybean oil. ard×peak area of sample/Peak area of mon- Epoxy resins (as listed in omer standard×sample weight in grams×30 § 175.300(b)(3)(viii)(a) of this chap- ter).. (e) Other specifications and limitations. Ethylene glycol monobutyl ether ...... Solvent. The polystyrene and rubber-modified Magnesium chloride. Methyl isobutyl ketone ...... Solvent. polystyrene identified in and com- Naphthalene sulfonic acid-formalde- plying with this section, when used as hyde condensate, sodium salt.
293
VerDate 06
List of substances Limitations imum 92 percent) and 4,4′- sulfonylbis[phenol] (maximum 8 per- Sodium dibutyl naphthalene Wetting agent. sulfonate. cent) (CAS Reg. No. 88285–91–0) pro- Sodium hydrosulfide. duced when a mixture of 4,4′- Sodium polysulfide. isopropylidenediphenol (minimum 92 β,β′,γ,γ′-Tetrachloro normal propyl Cross-linking agent. ′ ether. percent) and 4,4 -sulfonylbis[phenol] Titanium dioxide. (maximum 8 percent) is made to react Toluene ...... Solvent. with 4,4′-dichlorodiphenyl sulfone in Trichloroethane ...... Cross-linking agent. such a way that the finished resin has 1,2,3-Trichloropropane ...... Do. Urea-formaldehyde resins. a minimum number average molecular Xylene ...... Solvent. weight of 26,000, as determined by os- motic pressure in dimethylformamide. (b) The resins are used as the food- (b) The basic polysulfone resins iden- contact surface for dry food. tified in paragraph (a) of this section (c) An appropriate sample of the fin- may contain optional adjuvant sub- ished resin in the form in which it con- stances required in the production of tacts food, when subjected to ASTM such basic resins. The optional adju- method D968–81, ‘‘Standard Test Meth- vant substances required in the produc- ods for Abrasion Resistance of Organic tion of the basic polysulfone resins Coatings by the Falling Abrasive Test- may include substances described in er,’’ which is incorporated by reference § 174.5(d) of this chapter and the fol- (copies may be obtained from the lowing: American Society for Testing Mate- rials, 1916 Race St., Philadelphia, PA List of substances Limitations 19103, or may be examined at the Office Dimethyl sulfoxide ..... Not to exceed 50 parts per million as of the Federal Register, 800 North Cap- residual solvent in finished basic itol Street, NW., suite 700, Washington, resin in paragraph (a)(1) of this DC 20408), using No. 50 Emery abrasive section. in lieu of Ottawa sand, shall exhibit Monochlorobenzene .. Not to exceed 500 parts per million as residual solvent in finished and abrasion coefficient of not less basic resin in paragraph (a)(1) of than 20 liters per mil of film thickness. this section. N-methyl-2- Not to exceed 0.01 percent (100 [42 FR 14572, Mar. 15, 1977, as amended at 49 pyrrolidone. parts per million) as residual sol- FR 10110, Mar. 19, 1984] vent in finished basic resin in para- graph (a)(2) of this section. § 177.1655 Polysulfone resins. Polysulfone resins identified in para- (c) Polysulfone resins, when ex- graph (a) of this section may be safely tracted at reflux temperatures for 6 used as articles or components of arti- hours with the solvents—distilled cles intended for use in contact with water, 50 percent (by volume) ethyl al- food, in accordance with the following cohol in distilled water, 3 percent ace- prescribed conditions: tic acid in distilled water, and n- (a) For the purpose of this section, heptane, yield total extractives in each polysulfone resins are: extracting solvent not to exceed 0.0078 (1) Poly(oxy-p-phenylenesulfonyl-p- milligram per square centimeter (0.05 phenyleneoxy-p- milligram per square inch) of resin sur- phenyleneisopropylidene-p-phenylene) face. Note: In testing the finished resins (CAS Reg. No. 25154–01–2) con- polysulfone resins, use a separate resin sisting of basic resins produced when test sample for each required extract- the disodium salt of 4,4′- ing solvent. isopropylidenediphenol is made to (d) Polysulfone resins intended for re- react with 4,4′-dichlorodiphenyl sulfone peated use in contact with food may be in such a way that the finished resins used under conditions of use A through have a minimum number average mo- H in table 2 of § 176.170(c) of this chap- lecular weight of 15,000, as determined ter. The resins intended for single-serv- by osmotic pressure in ice food-contact use may be used only monochlorobenzene; or under condition of use H described in (2) 1,1′-Sulfonylbis[4-chlorobenzene] table 2 of § 176.170(c) of this chapter. polymer with 4,4′-(1- [51 FR 882, Jan. 9, 1986; 51 FR 4165, Feb. 3, methylethylidene)bis[phenol] (min- 1986; 61 FR 29475, June 11, 1996]
294
VerDate 06
§ 177.1660 Poly (tetramethylene (ii) Not to exceed 0.02 milligram per terephthalate). square inch of food contact surface ° Poly(tetramethylene terephthalate) when extracted for 2 hours at 150 F (poly (oxytetramethyleneoxyter- with n-heptane. ephthaloyl)) [Chemical Abstracts Serv- (iii) Not to exceed 0.04 milligram per ice Registry No. 24968–12–5] identified square inch of food contact surface ° in this section may be safely used as when extracted for 2 hours at 212 F articles or components of articles in- with 3 percent aqueous acetic acid. tended to contact food, in accordance (iv) Not to exceed 0.02 milligram per with the following prescribed condi- square inch of food contact surface tions: when extracted for 2 hours at 65.6 °C ° (a) Identity. For the purpose of this (150 F) with 50 percent ethanol. section, poly (tetramethylene [42 FR 14572, Mar. 15, 1977, as amended at 50 terephthalate) is the reaction product FR 20748, May 20, 1985; 52 FR 20069, May 29, of dimethyl terephthalate with 1,4- 1987] butanediol to which may have been added certain optional substances to § 177.1670 Polyvinyl alcohol film. impart desired technological properties Polyvinyl alcohol film may be safely to the polymer. used in contact with food of the types (b) Optional adjuvant substances. identified in § 176.170(c) of this chapter, Poly(tetramethylene terephthalate) table 1, under Types V, VIII, and IX, in identified in paragraph (a) of this sec- accordance with the following pre- tion may contain optional adjuvant scribed conditions: substances. The quantity of any op- (a) The polyvinyl alcohol film is pro- tional adjuvant substance employed in duced from polyvinyl alcohol having a the production of the polymer does not minimum viscosity of 4 centipoises exceed the amount reasonably required when a 4-percent aqueous solution is to accomplish the intended technical tested at 20 °C. or physical effect. Such adjuvants may (b) The finished food-contact film for include substances generally recog- use in contact with Food Types V or nized as safe in food, substances used in IX, when extracted with the solvent accordance with prior sanction, and characterizing the type of food and substances permitted under applicable under the conditions of time and tem- regulations in this part. perature characterizing its intended (c) Specifications. (1) Inherent vis- use as determined from tables 1 and 2 cosity of a 0.50 percent solution of the of § 176.170(c) of this chapter, yields polymer in phenol/tetrachloroethane total extractives not to exceed 0.078 (60/40 weight ratio) solvent is not less milligram per square centimeter (0.5 than 0.6 as determined using a Wagner milligram per square inch) of food-con- viscometer (or equivalent) and cal- tact surface when tested by ASTM culated from the following equation: method F34–76 (Reapproved 1980), (natural log arithm of N ) ‘‘Standard Test Method for Liquid Ex- Inherent = r traction of Flexible Barrier Materials,’’ viscos ity (c) which is incorporated by reference. Copies may be obtained from the Amer- where: ican Society for Testing Materials, 1916 Nr=Ratio of flow time of the polymer solu- Race St., Philadelphia, PA 19103, or tion to that of the solvent and c=polymer may be examined at the Office of the concentration of the test solution in grams per 100 milliliters. Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC (2) Poly(tetramethylene 20408. terephthalate) in the finished form in which it is to contact food shall yield (c) The finished food-contact film total extractives as follows: shall not be used as a component of (i) Not to exceed 0.08 milligram per food containers intended for use in con- square inch of food contact surface tact with water. when extracted for 2 hours at 250 °F [42 FR 14572, Mar. 15, 1977, as amended at 49 with distilled water. FR 10110, Mar. 19, 1984]
295
VerDate 06
§ 177.1680 Polyurethane resins. α-Hydro-omega-hydroxypoly (oxytetra- methylene). The polyurethane resins identified in α,α′-(Isopropylidenedi-p-phenylene)bis[omega- paragraph (a) of this section may be hydroxypoly (oxypropylene)(3–4 moles)], safely used as the food-contact surface average molecular weight 675. of articles intended for use in contact Maleic anhydride. with bulk quantities of dry food of the Methyl oxirane polymer with oxirane (CAS type identified in § 176.170(c) of this Reg. No. 9003–11–6). chapter, table 1, under Type VIII, in ac- Methyl oxirane polymer with oxirane, ether with 1,2,3–propanetriol (CAS Reg. No. 9082– cordance with the following prescribed 00–2). conditions: α,α′α″,α′″-Neopentanetetrayltetrakis [omega- (a) For the purpose of this section, hydroxypoly (oxypropylene) (1–2 moles)], polyurethane resins are those produced average molecular weight 400. when one or more of the isocyanates Pentaerythritol-linseed oil alcoholysis prod- listed in paragraph (a)(1) of this section uct. is made to react with one or more of Phthalic anhydride. the substances listed in paragraph Polybutylene glycol. (a)(2) of this section: Polyethyleneadipate modified with ethanol- amine with the molar ratio of the amine to (1) Isocyanates: the adipic acid less than 0.1 to 1. Bis(isocyanatomethyl) benzene (CAS Reg. Poly(oxycarbonylpentamethylene). No. 25854–16–4). Polyoxypropylene ethers of 4.4′-isopropyl- Bis(isocyanatomethyl) cyclohexane (CAS idenediphenol (containing an average of 2– Reg. No. 38661–72–2). 4 moles of propylene oxide). 4,4′-Diisocyanato-3,3′-dimethylbiphenyl (bi- Polypropylene glycol. tolylene diisocyanate). α,α′,α″-1,2,3-Propanetriyltris [omega- Diphenylmethane diisocyanate. hydroxypoly (oxypropylene) (15–18 moles)], Hexamethylene diisocyanate. average molecular weight 3,000. 3-Isocyanatomethyl - 3,5,5 - trimethylcyclo- Propylene glycol. hexyl isocyanate. α,α′,α″-[Propylidynetris (methylene)] tris 4,4-Methylenebis(cyclohexyl isocyanate). [omega-hydroxypoly (oxypropylene) (min- Toluene diisocyanate. imum 1.5 moles)], minimum molecular weight 400. (2) List of substances: α-[ρ(1,1,3,3-Tetramethylbutyl) - phenyl]- Adipic acid. omega-hydroxypoly(oxyethylene) (5 moles), 1,4-Butanediol. average molecular weight 425. 1,3-Butylene glycol. Trimethylol propane. 1,4–Cyclohexane dimethanol (CAS Reg. No. (b) Optional adjuvant substances em- 105–08–8). ployed in the production of the poly- 2,2-Dimethyl-1,3-propanediol. Ethylene glycol. urethane resins or added thereto to im- 1,6–Hexanediol (CAS Reg. No. 629–11–8).α– part desired technical or physical prop- Hydro–οµεγα–hydroxypoly(oxy–1,4– erties may include the following sub- butanediyl) (CAS Reg. No. 25190–06–1). stances:
List of substances Limitations
1-[(2-Aminoethyl)amino]2-propanol ...... As a curing agent. 1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride ...... As a preservative. Colorants used in accordance with § 178.3297 of this chapter.. Dibutyltin diacetate ...... As a catalyst. Dibutyltin dichloride ...... Do. Dibutyltin dilaurate ...... Do. N,N-Dimethyldodecylamine ...... Do. N-Dodecylmorpholine ...... Do. a,a′-[Isopropylidenebis[p-phenyleneoxy(2-hydroxytrimethylene) As a stabilizer. ]]bis[omega-hydroxypoly-(oxyethylene) (136±170 moles)], 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.
296
VerDate 06
List of substances Limitations
Tetrakis [methylene±(2,5±di-tert-butyl-4-hydroxyhydrocinna- Stabilizer. mate)]methane (CAS Reg. No. 6683±19±8). N,N,N′N′-Tetrakis (2-hydroxypropyl)ethylenediamine ...... As a curing agent. Triethanolamine ...... Do. Trimethyleneglycol di (p-aminobenzoate) (CAS Reg. No. As a curing agent. 57609±64±0).
(c) An appropriate sample of the fin- components of articles intended for use ished resin in the form in which it con- in contact with food, subject to provi- tacts food, when subjected to ASTM sions of this section. method D968–81, ‘‘Standard Test Meth- (a) For the purpose of this section, ods for Abrasion Resistance of Organic styrene block polymers are basic poly- Coatings by the Falling Abrasive Test- mers manufactured as described in this er,’’ which is incorporated by reference paragraph, so that the finished poly- (copies may be obtained from the mers meet the specifications prescribed American Society for Testing Mate- in paragraph (b) of this section, when rials, 1916 Race St., Philadelphia, PA tested by the methods described in 19103, or may be examined at the Office paragraph (c) of this section. of the Federal Register, 800 North Cap- (1) Styrene block polymers with 1,3- itol Street, NW., suite 700, Washington, butadiene are those produced by the DC 20408), using No. 50 Emery abrasive catalytic solution polymerization of in lieu of Ottawa sand, shall exhibit an styrene and 1,3-butadiene. abrasion coefficient of not less than 20 (2) Styrene block polymers with 2- liters per mil of film thickness. methyl-1,3-butadiene are those pro- [42 FR 14572, Mar. 15, 1977, as amended at 46 duced by the catalytic solution polym- FR 57033, Nov. 20, 1981; 49 FR 10110, Mar. 19, erization of styrene and 2-methyl-1,3- 1984; 50 FR 51847, Dec. 20, 1985; 56 FR 15278, butadiene. Apr. 16, 1991; 56 FR 42933, Aug. 30, 1991] (3) Styrene block polymers with 1,3- butadiene, hydrogenated are those pro- § 177.1810 Styrene block polymers. duced by the catalytic solution polym- The styrene block polymers identi- erization of styrene and 1,3-butadiene, fied in paragraph (a) of this section and subsequently hydrogenated. may be safely used as articles or as (b) Specifications:
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, IV±B, VI, VII±B, (¥96 °F) temperature for (150 °F) for 2 hr and VIII identified in table 1 in and 86 °C 30 min on a 0.19 on a 0.19 cm § 176.170(c) of this chapter under (187 °F) to cm (0.075 in) (0.075 in) thick conditions of use D, E, F, and G de- 122 °C thick sample. sample. scribed in table 2 in § 176.170(c) of (252 °F). this chapter.
297
VerDate 06
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
(ii) Styrene block polymers with 1,3-bu- 29,000 ...... do ...... do ...... do ...... Do. tadiene; for use as components of pressure-sensitive adhesives that contact food of Types I, II, IV±B, VI, VII±B, and VIII identified in table 1 in § 176.170(c) of this chapter under conditions of use C, D, E, F and G described in table 2 in § 176.170(c) of this chapter, provided the pressure- sensitive adhesives be applied only to closure tapes for sealing 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, IV±B, VI, °F) and 86 temperature for 2 (150 °F) for 2 hr VII±B, 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. 66070±58±4): 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, IV±B, VI, (198 °F) to hr on a 0.071 cm on a 0.071 cm VII±B, 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. 66070±58±4): for use at levels not to exceed 42.4 percent by weight as a component of closures with sealing gaskets that would contact food of Types III, IV±A, V, VII±A, VIII, and IX identified in table 1 in § 176.170(c) of this chapter, and in condition of use D as described under table 2 in § 176.170(c) of this chapter.
(c) The analytical methods for deter- (2) Glass transition points. The glass mining whether styrene block poly- transition points shall be determined mers conform to the specifications pre- by either of the following methods: scribed in this section are as follows (i) ASTM method D2236–70 (‘‘Stand- and are applicable to the finished poly- ard Method of Test for Dynamic Me- mer. chanical Properties of Plastics by (1) Molecular weight. Molecular Means of Torsional Pendulum,’’ which weight shall be determined by intrinsic is incorporated by reference; copies are viscosity (or other suitable method). available from American Society for Testing and Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or
298
VerDate 06
available for inspection at the Office of ethanol, and the maximum net residue the Federal Register, 800 North Capitol solubles in chloroform, shall be deter- Street, NW., suite 700, Washington, DC mined in accordance with § 176.170(d)(3) 20408) modified by using a forced reso- of this chapter using a sandwich form nant vibration instead of a fixed vibra- of the finished copolymer of the speci- tion and by using frequencies of 25 to 40 fied thickness and for the time and cycles per second instead of 0.1 to 10 temperature specified in paragraph (b) cycles per second. of this section. (ii) Direct reading viscoelastometric (d) The provisions of this section are method titled ‘‘Direct Reading not applicable to butadiene-styrene co- Viscoelastrometric Method for Deter- polymers listed in other sections of mining Glass Transition Points of Sty- this subpart. rene Block Polymers’’ (which is incor- (e) The provisions of this section are porated by reference; copies are avail- not applicable to styrene block poly- able from the Center for Food Safety mers with 1,3-butadiene listed in and Applied Nutrition (HFS–200), Food § 175.105 of this chapter. and Drug Administration, 200 C St. SW., Washington, DC 20204, or available [42 FR 14572, Mar. 15, 1977, as amended at 42 for inspection at the Office of the Fed- FR 43621, Aug. 30, 1977; 47 FR 11844, Mar. 19, eral Register, 800 North Capitol Street, 1982; 51 FR 16828, May 7, 1986; 54 FR 24898, NW., suite 700, Washington, DC 20408), June 12, 1989; 58 FR 65546, Dec. 15, 1993] by which the glass transition points § 177.1820 Styrene-maleic anhydride are determined in the tensile mode of copolymers. deformation at a frequency of 35 hertz using a Rheovibron Model DDV–II (or Styrene-maleic anhydride copoly- equivalent) Direct Reading mers identified in paragraph (a) of this Viscoelastometer. Take maxima in the section may be safely used as articles out-of-phase component of the complex or components of articles intended for modulus as the glass transition points. use in contact with food, subject to For block polymers of low styrene con- provisions of this section. tent or for simple block polymers, the (a) For the purpose of this section, polymer may be treated with 0.3 part styrene-maleic anhydride copolymers per hundred dicumyl peroxide and are those produced by the polymeriza- cured for 30 minutes at 153 °C to accen- tion of styrene and maleic anhydride so tuate the upper transition point. that the finished polymers meet the (3) Maximum extractable fractions in specifications prescribed in paragraph distilled water and 50 percent ethanol and (b) of this section, when tested by the the maximum net residue solubles in chlo- methods described in paragraph (c) of roform. The maximum extractable frac- this section. tions in distilled water and 50 percent (b) Specifications:
Maximum extract- Maximum extract- Molecular Residual able fraction in dis- able fraction in n- weight Residual sty- maleic anhy- tilled water at spec- heptane at speci- Styrene-maleic copolymers (minimum rene mon- dride mon- ified temperatures, fied temperatures, number omer omer times, and particle times, and particle average) size size
1. Styrene-maleic anhydride copoly- 70,000 0.3 weight 0.1 weight 0.006 weight per- 0.02 weight percent mers containing not more than 15 pct percent. percent. cent at reflux at 73 °F for 2 hr maleic anhydride units by weight; for temperature for 1 utilizing particles use as articles or as components of hr utilizing par- of a size that will articles that contact food of Types I, ticles of a size pass through a II, III, IV±A, IV±B, V, VI±B (except that will pass U.S. standard carbonated beverages), VII±A, VII±B, through a U.S. sieve No. 10 and VIII, and IX identified in table 1 in standard sieve will be held on a § 176.170(c) of this chapter under No. 10 and will U.S. standard conditions of use B, C, D, E, F, G, be held on a sieve No. 20. and H described in table 2 in U.S. standard § 176.170(c) of this chapter. sieve No. 20.
299
VerDate 06
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
2. Styrene-maleic anhydride copolymer ...... 0.3 ...... 0.1 ...... 0.015 weight per- 1.0 weight percent modified with butadiene, (CAS Reg. cent at reflux at 23 °C (73 °F) No. 27288±99±9) containing not temperature for 1 for 2 hours uti- more than 15 percent maleic anhy- hour utilizing par- lizing particles of dride units by weight and not more ticles of a size a size that will than 20 percent styrene-butadiene that will pass pass through a and/or butadiene rubber units by through a U.S. U.S. standard weight; for use (except carbonated standard sieve sieve No. 10 and beverage bottles) as articles or as No. 10 and will will be held on a components of articles that contact be held on a U.S. standard food of Types I, II, III, IV±A, IV±B, V, U.S. standard sieve No. 20. VI, VII±A, VII±B, VIII, and IX identi- sieve No. 20. fied in table I in § 176.170(c) of this chapter under conditions of use B, C, D, E, F, G, and H described in table 2 in § 176.170(c) of this chapter.
(c) The analytical methods for deter- § 177.1830 Styrene-methyl methacry- mining conformance with specifica- late copolymers. tions for styrene-maleic anhydride co- Styrene-methyl methacrylate co- polymers prescribed in this section are polymers identified in this section may as follows: be safely used as components of plastic (1) Molecular weight. Molecular articles intended for use in contact weight shall be determined by mem- with food, subject to the provisions of brane osmometry. this section. (2) Residual styrene monomer content. (a) For the purpose of this section, Residual styrene monomer content styrene-methyl methacrylate copoly- shall be determined by the method de- mers consist of basic copolymers pro- scribed in § 177.1640(d). duced by the copolymerization of sty- (3) Residual maleic anhydride monomer rene and methyl methacrylate such content. Residual maleic anhydride that the finished basic copolymers con- monomer content shall be determined tain more than 50 weight percent of by a gas chromatographic method ti- polymer units derived from styrene. tled ‘‘Determination of Residual Ma- (b) The finished plastic food-contact leic Anhydride in Polymers by Gas article, when extracted with the sol- Chromatography,’’ which is incor- vent or solvents characterizing the porated by reference. Copies are avail- type of food and under the conditions able from the Center for Food Safety of time and temperature characterizing and Applied Nutrition (HFS–200), Food the conditions of intended use as deter- and Drug Administration, 200 C St. mined from tables 1 and 2 of § 176.170(c) SW., Washington, DC 20204, or available of this chapter, yields extractives not for inspection at the Office of the Fed- to exceed the following when tested by eral Register, 800 North Capitol Street, the methods prescribed in § 177.1010(c); NW., suite 700, Washington, DC 20408. (1) Total nonvolatile extractives not (d) The provisions of this section are to exceed 0.3 milligram per square inch not applicable to styrene-maleic anhy- of surface tested. dride copolymers listed in other sec- (2) Potassium permanganate oxidiz- tions of this subpart. able distilled water and 8 and 50 per- cent alcohol extractives not to exceed [42 FR 14572, Mar. 15, 1977, as amended at 47 an absorbance of 0.15. FR 11844, Mar. 19, 1982; 47 FR 14698, Apr. 6, 1982; 54 FR 24898, June 12, 1989] (3) Ultraviolet-absorbing distilled water and 8 and 50 percent alcohol ex- tractives not to exceed an absorbance of 0.30.
300
VerDate 06
(4) Ultraviolet-absorbing n-heptane § 177.1900 Urea-formaldehyde resins in extractives not to exceed an absorb- molded articles. ance of 0.40. Urea-formaldehyde resins may be safely used as the food-contact surface § 177.1850 Textryls. of molded articles intended for use in Textryls identified in this section contact with food, in accordance with may be safely used as articles or com- the following prescribed conditions: ponents of articles, intended for use in (a) For the purpose of this section, producing, manufacturing, packing, urea-formaldehyde resins are those processing, preparing, treating, pack- produced when 1 mole of urea is made aging, transporting or holding food, to react with not more than 2 moles of subject to the provisions of this sec- formaldehyde in water solution. tion. (b) The resins may be mixed with re- (a) Textryls are nonwoven sheets pre- fined wood pulp and the mixture may pared from natural or synthetic fibers, contain other optional adjuvant sub- bonded with fibryl (Fibryl consists of a stances which may include the fol- polymeric resin in fibrous form com- lowing: mingled with fiber to facilitate sheet List of substances Limitations formation and subsequently heat cured to fuse the fibryl and effect bonding). Hexamethylenetetramine ...... For use only as polymeriza- tion-control agent. (b) Textryls are prepared from the fi- Tetrachlorophthalic acid an- Do. bers, fibryls, and adjuvants identified hydride. in paragraph (c) of this section, and Zinc stearate ...... For use as lubricant. subject to limitations prescribed in that paragraph, provided that any sub- (c) The finished food-contact article, stance that is the subject of a regula- when extracted with the solvent or sol- vents characterizing the type of food tion in parts 174, 175, 176, 177, 178 and and under the conditions of time and § 179.45 of this chapter conforms with temperature characterizing the condi- any specifications in such regulation tions of its intended use as determined for that substance as a component of from tables 1 and 2 of § 175.300(d) of this polymeric resins used as food contact chapter, yields total extractives in surfaces. each extracting solvent not to exceed (c) The fibers, fibryls, and adjuvants 0.5 milligram per square inch of food- permitted are as follows: contact surface as determined by the methods described in § 175.300(e) of this Substances Limitations chapter. (1) Fibers prepared from pol- Conforming with § 177.1630. NOTE: In testing the finished food-contact yethylene terephthalate article, use a separate test sample for each resins. required extracting solvent. (2) Fibryls prepared from As the basic polymer. vinyl chloride-vinyl acetate copolymer. § 177.1950 Vinyl chloride-ethylene co- (3) Adjuvant substance, As a solvent in the prepara- polymers. dimethylformamide. tion of fibryl. The vinyl chloride-ethylene copoly- mers identified in paragraph (a) of this (d) Textryls meeting the conditions section may be safely used as compo- of test prescribed in paragraph (d)(1) of nents of articles intended for contact this section are used as prescribed in with food, under conditions of use D, E, paragraph (d)(2) of this section. F, or G described in table 2 of § 176.170 (1) Conditions of test. Textryls, when (c) of this chapter, subject to the provi- extracted with distilled water at reflux sions of this section. temperature for 1 hour, yield total ex- (a) For the purpose of this section, tractives not to exceed 1 percent. vinyl chloride-ethylene copolymers (2) Uses. Textryls are used for pack- consist of basic copolymers produced aging or holding food at ordinary tem- by the copolymerization of vinyl chlo- peratures and in the brewing of hot ride and ethylene such that the fin- beverages. ished basic copolymers meet the speci- fications and extractives limitations
301
VerDate 06
prescribed in paragraph (c) of this sec- (d) Analytical methods: The analyt- tion, when tested by the methods de- ical methods for determining whether scribed in paragraph (d) of this section. vinyl chloride-ethylene basic copoly- (b) The basic vinyl chloride-ethylene mers conform to the extractives limi- copolymers identified in paragraph (a) tations prescribed in paragraph (c) of of this section may contain optional this section are as follows and are ap- adjuvant substances required in the plicable to the basic copolymers in production of such basic copolymers. powder form having a particle size such The optional adjuvant substances re- that 100 percent will pass through a quired in the production of the basic U.S. Standard Sieve No. 40 and 80 per- vinyl chloride-ethylene copolymers cent will pass through a U.S. Standard may include substances permitted for Sieve No. 80: such use by regulations in parts 170 (1) Reagents—(i) Water. All water used through 189 of this chapter, substances in these procedures shall be generally recognized as safe in food, demineralized (deionized), freshly dis- and substances used in accordance with tilled water. 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 (iii) Total extractives obtained by ex- 150 °F in the case of the heptane ex- tracting with water at 150 °F for 2 tract. In the case of the aqueous ex- hours contain no more than 0.5 milli- tract, the evaporation to constant gram of vinyl chloride-ethylene copol- weight is completed in 15 minutes at ymer per 100 grams of sample tested as 230 °F; and in the case of heptane ex- determined from the organic chlorine tract, it is overnight under vacuum at content. The organic chlorine content 150 °F. The residue is weighed and cor- is determined as described in paragraph rected for the solvent blank. Calcula- (d)(3) of this section. tion:
302
VerDate 06
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.
Milligrams of aqueous extracted TF× × 64.3 = ×100 copolymer per 100-gram sample Weight of sample in grams
where: T=Milliliters of silver nitrate (sample minus blank)×normality of silver nitrate.
303
VerDate 06
F=1,200/A (as defined above) cosity of Vinyl Chloride Polymers,’’ (e) The vinyl chloride-ethylene co- which is incorporated by reference. polymers identified in and complying Copies may be obtained from the Amer- with this section, when used as compo- ican Society for Testing Materials, 1916 nents of the food-contact surface of Race St., Philadelphia, PA 19103, or any article that is the subject of a reg- may be examined at the Office of the ulation in parts 174, 175, 176, 177, 178 Federal Register, 800 North Capitol and § 179.45 of this chapter, shall com- Street, NW., suite 700, Washington, DC ply with any specifications and limita- 20408. tions prescribed by such regulation for (2) Extractives limitations. The fol- the article in the finished form in lowing extractives limitations are de- which it is to contact food. termined by the methods prescribed in (f) The provisions of this section are § 177.1970(d). not applicable to vinyl chloride-ethyl- (i) Total extractives do not exceed ene copolymers used as provided in 0.01 weight percent when extracted ° §§ 175.105 and 176.180 of this chapter. with water at 150 F for 2 hours. (ii) Total extractives do not exceed [42 FR 14572, Mar. 15, 1977, as amended at 49 0.30 weight percent when extracted FR 10110, Mar. 19, 1984] with n-heptane at 150 °F for 2 hours. (c) Other specifications and limitations. § 177.1960 Vinyl chloride-hexene-1 co- polymers. The vinyl chloride-hexene-1 copoly- mers identified in and complying with The vinyl chloride-hexene-1 copoly- this section, when used as components mers identified in paragraph (a) of this of the food-contact surface of any arti- section or as components of articles in- cle that is subject to a regulation in tended for use in contact with food, parts 174, 175, 176, 177, 178 and § 179.45 of under conditions of use D, E, F, or G this chapter, shall comply with any described in table 2 of § 176.170(c) of this specifications and limitations pre- chapter, subject to the provisions of scribed by such regulation for the arti- this section. cle in the finished form in which it is (a) Identity. For the purposes of this to contact food. section vinyl chloride-hexene-1 copoly- mers consist of basic copolymers pro- [42 FR 14572, Mar. 15, 1977, as amended at 49 duced by the copolymerization of vinyl FR 10110, Mar. 19, 1984] chloride and hexene-1 such that the fin- ished copolymers contain not more § 177.1970 Vinyl chloride-lauryl vinyl than 3 mole-percent of polymer units ether copolymers. derived from hexene-1 and meet the The vinyl chloride-lauryl vinyl ether specifications and extractives limita- copolymers identified in paragraph (a) tions prescribed in paragraph (b) of this of this section may be used as an arti- section. The copolymers may option- cle or as a component of an article in- ally contain hydroxypropyl methyl- tended for use in contact with food sub- cellulose and trichloroethylene used as ject to the provisions of this section. a suspending agent and chain transfer (a) Identity. For the purposes of this agent, respectively, in their produc- section vinyl chloride-lauryl vinyl tion. ether copolymers consist of basic co- (b) Specifications and limitations. The polymers produced by the copolym- vinyl chloride-hexene-1 basic copoly- erization of vinyl chloride and lauryl mers meet the following specifications vinyl ether such that the finished co- and extractives limitations: polymers contain not more than 3 (1) Specifications. (i) Total chlorine weight-percent of polymer units de- content is 53 to 56 percent as deter- rived from lauryl vinyl ether and meet mined by any suitable analytical pro- the specifications and extractives limi- cedure of generally accepted applica- tations prescribed in paragraph (c) of bility. this section. (ii) Inherent viscosity in (b) Optional adjuvant substances. The cyclohexanone at 30 °C is not less than basic vinyl chloride-lauryl vinyl ether 0.59 deciliters per gram as determined copolymers identified in paragraph (a) by ASTM method D1243–79, ‘‘Standard of this section may contain optional Test Method for Dilute Solution Vis- adjuvant substances required in the
304
VerDate 06
production of such basic copolymers. borosilicate flask, and for each gram of These optional adjuvant substances sample add 3 milliliters of solvent pre- may include substances permitted for viously heated to 150 °F. Maintain the such use by regulations in parts 170 temperature of the contents of the through 189 of this chapter, substances flask at 150 °F for 2 hours using a hot generally recognized as safe in food, plate while also maintaining gentle and substances used in accordance with mechanical agitation. Filter the con- a prior sanction or approval. tents of the flask rapidly through No. (c) Specifications and limitations. The 42 Whatman filter paper with the aid of vinyl chloride-lauryl vinyl ether basic suction. Transfer the filtrate to flat copolymers meet the following speci- glass dishes that are warmed on a hot fications and extractives limitations: plate and evaporate the solvent with (1) Specifications. (i) Total chlorine the aid of a stream of filtered air. When content is 53 to 56 percent as deter- the volume of the filtrate has been re- mined by any suitable analytical pro- duced to 10 to 15 milliliters, transfer cedure of generally accepted applica- the filtrate to tared 50-milliliter bility. borosilicate glass beakers and com- (ii) Inherent viscosity in plete evaporation to a constant weight cylcoHhexanone at 30 °C is not less in a 140 °F vacuum oven. Carry out a than 0.60 deciliter per gram as deter- corresponding blank determination mined by ASTM method D1243–79, with each solvent. Determine the ‘‘Standard Test Method for Dilute So- weight of the residue corrected for the lution Viscosity of Vinyl Chloride solvent blank and calculate the result Polymers,’’ which is incorporated by as percent of the initial weight of the reference. Copies may be obtained from resin sample taken for analysis. the American Society for Testing Ma- (e) Other specifications and limitations. terials, 1916 Race St., Philadelphia, PA The vinyl chloride-lauryl vinyl ether 19103, or may be examined at the Office copolymers identified in and complying of the Federal Register, 800 North Cap- with this section, when used as compo- itol Street, NW., suite 700, Washington, nents of the food-contact surface of DC 20408. any article that is subject to a regula- (2) Extractives limitations. The fol- tion in parts 174, 175, 176, 177, 178 and lowing extractives limitations are de- § 179.45 of this chapter, shall comply termined by the method described in with any specifications and limitations paragraph (d) of this section: prescribed by such regulation for the (i) Total extractives do not exceed article in the finished form in which it 0.03 weight-percent when extracted is to contact food. with water at 150 °F for 2 hours. (ii) Total extractives do not exceed [42 FR 14572, Mar. 15, 1977, as amended at 49 0.60 weight-percent when extracted FR 10110, Mar. 19, 1984] with n-heptane at 150 °F for 2 hours. (d) Analytical methods. The analytical § 177.1980 Vinyl chloride-propylene co- polymers. methods for determining total extrac- tives are applicable to the basic co- The vinyl chloride-propylene copoly- polymers in powder form having a par- mers identified in paragraph (a) of this ticle size such that 100 percent will section may be safely used as compo- pass through a U.S. Standard Sieve No. nents of articles intended for contact 40 and such that not more than 10 per- with food, subject to the provisions of cent will pass through a U.S. Standard this section. Sieve No. 200. (a) For the purpose of this section, (1) Reagents—(i) Water. All water used vinyl chloride-propylene copolymers in these procedures shall be consist of basic copolymers produced demineralized (deionized), freshly dis- by the copolymezation of vinyl chlo- tilled water. ride and propylene such that the fin- (ii) n-Heptane. Reagent grade, freshly ished basic copolymers meet the speci- distilled n-heptane shall be used. fications and extractives limitations (2) Determination of total amount of ex- prescribed in paragraph (c) of this sec- tractives. Place an accurately weighed tion, when tested by the methods de- sample of suitable size in a clean scribed in paragraph (d) of this section.
305
VerDate 06
(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 content is in the range of 53 to 56 per- (2) Determination of total amount of ex- cent as determined by any suitable an- tractives. All determinations shall be alytical procedure of generally accept- done in duplicate using duplicate ed applicability. blanks. Approximately 400 grams of (ii) Intrinsic viscosity in cyclo- sample (accurately weighed) shall be hexanone at 30 °C is not less than 0.50 placed in a 2-liter Erlenmeyer flask. deciliter per gram as determined by Add 1,200 milliliters of solvent and ASTM method D1243–79, ‘‘Standard cover the flask with aluminum foil. Test Method for Dilute Solution Vis- The covered flask and contents are sus- cosity of Vinyl Chloride Polymers,’’ pended in a thermostated bath and are ° which is incorporated by reference. kept, with continual shaking, at 150 F Copies may be obtained from the Amer- for 2 hours. The solution is then fil- ican Society for Testing Materials, 1916 tered through a No. 42 Whatman filter Race St., Philadelphia, PA 19103, or paper, and the filtrate is collected in a may be examined at the Office of the graduated cylinder. The total amount Federal Register, 800 North Capitol of filtrate (without washing) is meas- Street, NW., suite 700, Washington, DC ured and called A milliliters. The fil- 20408. trate is transferred to a Pyrex (or (2) Extractives limitations. The fol- equivalent) beaker and evaporated on a lowing extractives limitations are de- steam bath under a stream of nitrogen termined by the methods described in to a small volume (approximately 50–60 paragraph (d) of this section: milliliters). The concentrated filtrate (i) Total extractives do not exceed is then quantitatively transferred to a 0.10 weight-percent when extracted tared 100-milliliter Pyrex beaker using with n-heptane at 150 °F for 2 hours. small, fresh portions of solvent and a (ii) Total extractives do not exceed rubber policeman to effect the transfer. 0.03 weight-percent when extracted The concentrated filtrate is evaporated with water at 150 °F for 2 hours. almost to dryness on a hotplate under (iii) Total extractives obtained by ex- nitrogen, and is then transferred to a tracting with water at 150 °F for 2 drying oven at 230 °F in the case of the hours contain no more than 0.17 milli- aqueous extract or to a vacuum oven at gram of vinyl chloride-propylene co- 150 °F in the case of the heptane ex- polymer per 100 grams of sample tested tract. In the case of the aqueous ex- as determined from the organic chlo- tract the evaporation to constant rine content. For the purpose of this weight is completed in 15 minutes at section, the organic chlorine content is 230 °F; and in the case of heptane ex- the difference between the total chlo- tract, it is overnight under vacuum at rine and ionic chlorine contents deter- 150 °F. The residue is weighed and cor- mined as described in paragraph (d) of rected for the solvent blank. Calcula- this section. tion:
306
VerDate 06
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: in paragraph (d)(2) of this section. Two A=volume of filtrate obtained in extraction. drops of 50 percent by weight sodium B=milliliters of silver nitrate solution used hydroxide solution are added and the in sample titration×normality of silver solution is evaporated to approxi- nitrate solution. mately 150 milliliters. The solution is C=milliliters of silver nitrate solution used quantitatively transferred to a 250-mil- × in blank titration normality of silver ni- liliter beaker, methyl purple indicator trate solution. is added, and the solution is neutral- (iii) Ionic chlorine content. A weighed ized with 0.1 N nitric acid. For each 100 sample is extracted with water at 150 milliliters of solution is added 1.5 mil- °F for 2 hours, filtered, and the volume liliters of 2 N nitric acid. The solution of filtrate is measured (A milliliters) as is titrated with 0.005 N silver nitrate to
307
VerDate 06
the equivalence potential end point, section. A complete blank must be run using the expanded scale pH meter de- in duplicate. Calculation: scribed in paragraph (d)(3)(ii) of this
DE− 1, 200 milliliters Milliequivalents of ionic chlorine in × ×100 = Grams of sample Volume of filtrate aqueousextract of100 gramsof sample. A in milliliters
where: (f) The provisions of this section are A=volume of filtrate obtained in extraction. not applicable to vinyl chloride-pro- D=milliliters of silver nitrate solution used pylene copolymers used in food-pack- in sample titration×normality of silver aging adhesives complying with nitrate solution. § 175.105 of this chapter. E=milliliters of silver nitrate solution used in blank titration×normality of silver ni- [42 FR 14572, Mar. 15, 1977, as amended at 49 trate solution. FR 10111, Mar. 19, 1984] (iv) Organic chlorine content and vinyl § 177.1990 Vinylidene chloride/methyl chloride-propylene copolymer content of acrylate copolymers. aqueous extract. The organic chlorine The vinylidene chloride/methyl acry- content and the vinyl chloride pro- late copolymers (CAS Reg. No. 25038– pylene copolymer content of the aque- 72–6) identified in paragraph (a) of this ous extract is calculated as follows: section may be safely used as an article (a) Organic chlorine content. Milli- or as a component of an article in- equivalents of organic chlorine in tended for use in contact with food sub- aqueous extract of 100 grams of sample ject to the provisions of this section. equal milliequivalents of total chlorine (a) Identity. For the purposes of this in aqueous extract of 100 grams of sam- section vinylidene chloride/methyl ac- ple (as calculated in paragraph (d)(3)(ii) rylate copolymers consist of basic co- of this section) minus milliequivalents polymers produced by the copolym- of ionic chlorine in aqueous extract of erization of vinylidene chloride and 100 grams of sample (as calculated in methyl acrylate such that the copoly- paragraph (d)(3)(iii) of this section). mers contain not more than 15 weight- (b) Vinyl chloride-propylene copolymer percent of polymer units derived from content. Milligrams of vinyl chloride- methyl acrylate. propylene copolymer in aqueous ex- (b) Optional adjuvant substances. The tract of 100 grams of sample equal basic vinylidene chloride/methyl acry- milliequivalents of organic chlorine in late copolymers identified in paragraph aqueous extract of 100 grams of sample (a) of this section may contain optional (as calculated in paragraph (d)(3)(iv) (a) adjuvant substances required in the of this section) multiplied by 84.5. production of such basic copolymers. NOTE: The conversion factor, 84.5, is de- These optional adjuvant substances rived from the equivalent weight of chlorine may include substances permitted for divided by the chlorine content of the such use by regulations in parts 170 heptane extractable fraction.) through 179 of this chapter, substances (e) The vinyl chloride-propylene co- generally recognized as safe in food, polymers identified in and complying and substances used in accordance with with this section, when used as compo- a prior sanction or approval. nents of the food-contact surface of (c) Specifications. (1) The methyl acry- any article that is the subject of a reg- late content is determined by an infra- ulation in parts 174, 175, 176, 177, 178 red spectrophotometric method titled and § 179.45 of this chapter, shall com- ‘‘Determination of Copolymer Ratio in ply with any specifications and limita- Vinylidene Chloride/Methyl Acrylate tions prescribed by such regulation for Copolymers,’’ which is incorporated by the article in the finished form in reference. Copies are available from which it is to contact food. the Center for Food Safety and Applied
308
VerDate 06
Nutrition (HFS–200), Food and Drug Sieve No. 45 (350 microns) shall meet Administration, 200 C St. SW., Wash- the following extractives limitations: ington, DC 20204, or available for in- (1) 10-gram samples of the resin, spection at the Office of the Federal when extracted separately with 100 Register, 800 North Capitol Street, milliliters of distilled water at 121 °C NW., suite 700, Washington, DC 20408. (250 °F) for 2 hours, and 100 milliliters (2) The weight average molecular of n-heptane at 66 °C (150 °F) for 2 weight of the copolymer is not less hours, shall yield total nonvolatile ex- than 50,000 when determined by gel per- tractives not to exceed 0.5 percent by meation chromatography using tetra- weight of the resin. hydrofuran as the solvent. The gel per- (2) The basic copolymer in the form meation chromatograph is calibrated of film when extracted separately with ° ° with polystyrene standards. The basic distilled water at 121 C (250 F) for 2 gel permeation chromatographic meth- hours shall yield total nonvolatile ex- od is described in ANSI/ASTM D3536–76, tractives not to exceed 0.047 milligram ‘‘Standard Test Method for Molecular per square centimeter (0.3 milligram Weight Averages and Molecular Weight per square inch). (e) Conditions of use. The copolymers Distribution of Polystyrene by Liquid may be safely used as articles or com- Exclusion Chromatography (Gel Per- ponents of articles intended for use in meation Chromatography-GPC),’’ producing, manufacturing, processing, which is incorporated by reference. preparing, treating, packaging, trans- Copies are available from University porting, or holding food, including Microfilms International, 300 North processing of packaged food at tem- Zeeb Rd., Ann Arbor, MI 48106, or avail- peratures not to exceed 135 °C (275 °F). able for inspection at the Office of the (f) Other specifications and limitations. Federal Register, 800 North Capitol The vinylidene chloride-methyl acry- Street, NW., suite 700, Washington, DC late copolymers identified in and com- 20408. plying with this section, when used as (3) Residual vinylidene chloride and components of the food contact surface residual methyl acrylate in the copoly- of any article that is subject to a regu- mer in the form in which it will con- lation in parts 174 through 178 and tact food (unsupported film, barrier § 179.45 of this chapter, shall comply layer, or as a copolymer for blending) with any specifications and limitations will not exceed 10 parts per million and prescribed by such regulation for the 5 parts per million, respectively, as de- article in the finished form in which it termined by either a gas is to contact food. chromatographic method titled ‘‘De- termination of Residual Vinylidene [48 FR 38605, Aug. 25, 1983; 48 FR 50077, Oct. Chloride and Methyl Acrylate in Vinyl- 31, 1983, as amended at 53 FR 47185, Nov. 22, 1988; 54 FR 24898, June 12, 1989] idene Chloride/Methyl Acrylate Co- polymer Resins and Films,’’ or, alter- § 177.2000 Vinylidene chloride/methyl natively, ‘‘Residual Methyl Acrylate acrylate/methyl methacrylate poly- and Vinylidene Chloride Monomers in mers. Saran MA/VDC Resins and Pellets by The vinylidene chloride/methyl acry- Headspace Gas Chromatography,’’ late/methyl methacrylate polymers dated March 3, 1986, which are incor- (CAS Reg. No. 34364–83–5) identified in porated by reference in accordance paragraph (a) of this section may be with 5 U.S.C. 552(a). Copies are avail- safely used as articles or as a compo- able from the Center for Food Safety nent of articles intended for use in con- and Applied Nutrition (HFS–200), Food tact with food subject to the provisions and Drug Administration, 200 C St. of this section. SW., Washington, DC 20204, or available (a) Identity. For the purpose of this for inspection at the Office of the Fed- section, vinylidene chloride/methyl ac- eral Register, 800 North Capitol Street, rylate/methyl methacrylate polymers NW., suite 700, Washington, DC 20408. consist of basic polymers produced by (d) Extractives limitations. The basic the copolymerization of vinylidene copolymer resin in the form of granules chloride/methyl acrylate/methyl meth- that will pass through a U.S. Standard acrylate such that the basic polymers
309
VerDate 06
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 rived from methyl acrylate monomer with food, subject to the provisions of and not more than 6 weight percent of this section. polymer units derived from methyl (a) Ethylene polymer, chloro- methacrylate monomer. sulfonated is produced by chloro- (ii) The basic polymers are limited to sulfonation of a carbon tetrachloride a thickness of not more than 0.005 cen- solution of polyethylene with chlorine timeter (0.002 inches). and sulfuryl chloride. (2) The weight average molecular (b) Ethylene polymer, chloro- weight of the basic polymer is not less sulfonated shall meet the following than 100,000 when determined by gel specifications: permeation chromatography using tet- (1) Chlorine not to exceed 25 percent rahydrofuran as the solvent. The gel by weight. permeation chromatography is cali- (2) Sulfur not to exceed 1.15 percent brated with polystyrene standards. The by weight. basic gel permeation chromatographic (3) Molecular weight is in the range method is described in ANSI/ASTM of 95,000 to 125,000. D3536–76, which is incorporated by ref- erence. Copies are available from the Methods for the specifications in this American Society for Testing Mate- paragraph (b), titled ‘‘Chlorine and rials, 1916 Race St., Philadelphia, PA Bromine—Coulometric Titration Meth- 19103, or available for inspection at the od by Aminco Chloridometer,’’ Office of the Federal Register, 800 ‘‘Hypolon Synthetic Rubber—Deter- North Capitol Street, NW., suite 700, mination of Sulfur by Parr Bomb,’’ and Washington, DC 20408. ASTM method D2857–70 (Reapproved
310
VerDate 06
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 be examined at the Office of the Fed- tial microbial adulteration of the food. eral Register, 800 North Capitol Street, (g) To assure safe use of the micro- NW., suite 700, Washington, DC 20408. porous polymeric filters, the label or (c) The additive is used as the article, labeling shall include adequate direc- or a component of articles, intended for tions for a pre-use treatment, con- use as liners and covers for reservoirs sisting of washing with a minimum of intended for the storage of water for 2 gallons of potable water at a tem- drinking purposes. perature of 180 °F for each square foot (d) Substances permitted by § 177.2600 of filter, prior to the filter’s first use in may be employed in the preparation of contact with food. ethylene polymers, chlorosulfonated, subject to any limitations prescribed [42 FR 14572, Mar. 15, 1977, as amended at 56 therein. FR 42933, Aug. 30, 1991] (e) The finished ethylene copolymers, § 177.2260 Filters, resin-bonded. chlorosulfonated shall conform to § 177.2600(e) and (g). Resin-bonded filters may be safely used in producing, manufacturing, [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984; 54 FR 24898, June 12, processing, and preparing food, subject 1989] to the provisions of this section. (a) Resin-bonded filters are prepared § 177.2250 Filters, microporous poly- from natural or synthetic fibers to meric. which have been added substances re- Microporous polymeric filters identi- quired in their preparation and fin- fied in paragraph (a) of this section ishing, and which are bonded with res- may be safely used, subject to the pro- ins prepared by condensation or polym- visions of this section, to remove par- erization of resin-forming materials, ticles of insoluble matter in producing, together with adjuvant substances re- manufacturing, processing, and pre- quired in their preparation, applica- paring bulk quantities of liquid food. tion, and curing. (a) Microporous polymeric filters (b) The quantity of any substance consist of a suitably permeable, contin- employed in the production of the uous, polymeric matrix of polyvinyl resin-bonded filter does not exceed the chloride, vinyl chloride-propylene, or amount reasonably required to accom- vinyl chloride-vinyl acetate, in which plish the intended physical or technical finely divided silicon dioxide is embed- effect or any limitation further pro- ded. Cyclohexanone may be used as a vided. solvent in the production of the filters. (b) Any substance employed in the (c) Any substance employed in the production of microporous polymeric production of resin-bonded filters that filters that is the subject of a regula- is the subject of a regulation in parts tion in parts 170 through 189 of this 174, 175, 176, 177, 178 and § 179.45 of this chapter must conform with any speci- chapter conforms with any specifica- fication in such regulation. tion in such regulation. (c) Cyclohexanone when used as a sol- (d) Substances employed in the pro- vent in the production of the filters duction of resin-bonded filters include shall not exceed 0.35 percent by weight the following, subject to any limita- of the microporous polymeric filters. tions provided:
311
VerDate 06
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 percent of total polymer units derived Cellulose pulp. 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. BHT. Melamine-formaldehyde chemically modified Butyl (or isobutyl) palmitate or stearate. with urea; for use only as provided for in 2,5-Di-tert-butyl hydroquinone for use only in paragraphs (e), (f), (g), (h), and (i) of this lubricant formulations for rayon fiber fin- section. ishing and at a usage level not to exceed Phenol-formaldehyde resins. 0.1 percent by weight of the lubricant for- Polyvinyl alcohol. mulations. Polyvinyl alcohol with the copolymer of Dimethylpolysiloxane. acrylic acid-allyl sucrose. 4-Ethyl-4-hexadecyl morpholinium ethyl sul- Polyvinyl alcohol with melamine formalde- fate for use only as a lubricant in the man- hyde. ufacture of polyethylene terephthalate fi- Polyvinyl acetate with melamine formalde- bers specified in paragraph (d)(1) of this hyde. section at a level not to exceed 0.03 percent p--Toluenesulfonamide-formaldehyde chemi- by weight of the finished fibers. cally modified with one or more of the Fatty acid (C10-C18) diethanolamide conden- amine catalysts identified in § 175.300 sates. (b)(3)(xiii) of this chapter. Fatty acids derived from animal or vegetable fats and oils, and salts of such acids, sin- (4) Adjuvant substances: gle or mixed, as follows: Aluminum. Dimethyl polysiloxane with methylcellulose Ammonium. and sorbic acid (as an antifoaming agent). Calcium. Phosphoric acid. Magnesium. Potassium. (5) Colorants: Colorants used in ac- Sodium. cordance with § 178.3297 of this chapter. Triethanolamine. (e) Resin-bonded filters conforming Fatty acid (C10-C18) mono- and diesters of with the specifications of paragraph (e) polyoxyethylene glycol (molecular weight (1) of this section are used as provided 400–3,000). in paragraph (e)(2) of this section: Methyl esters of fatty acids (C10-C18). Mineral oil. (1) Total extractives. The finished fil- Polybutene, hydrogenated; complying with ter, when exposed to distilled water at the identity prescribed under § 178.3740 (b) 100 °F for 2 hours, yields total extrac- of this chapter. tives not to exceed 2.8 percent by Polyoxyethylene (4 mols) ethylenediamine weight of the filter. monolauramide for use only in lubricant formulations for rayon fiber finishing and (2) Conditions of use. It is used to fil- at a usage level not to exceed 10 percent by ter milk or potable water at operating weight of the lubricant formulations. temperatures not to exceed 100 °F. Ricebran oil. (f) Resin-bonded filters conforming Titanium dioxide. with the specifications of paragraph (f) (3) Resins: (1) of this section are used as provided in paragraph (e)(2) of this section: Acrylic polymers produced by polymerizing (1) Total extractives. The finished fil- ethyl acrylate alone or with one or more of the monomers: Acrylic acid, acrylonitrile, ter, when exposed to distilled water at N-methylolacrylamide, and styrene. The 145 °F for 2 hours, yields total extrac- finished copolymers shall contain at least tives not to exceed 4 percent by weight 70 weight percent of polymer units derived of the filter.
312
VerDate 06
(2) Conditions of use. It is used to fil- (1) of this section are used as provided ter milk or potable water at operating in paragraph (k)(2) of this section: temperatures not to exceed 145 °F. (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 nonalcoholic, aqueous foods having a °F, provided that the finished filter pH above 5.0. when exposed to distilled water at 100 (j) Resin-bonded filters conforming °F for 2 hours yields total extractives with the specifications of paragraph (j) not to exceed 1 percent by weight of (1) of this section are used as provided the filter. in paragraph (j)(2) of this section: (2) The finished filter may be used to (1) Total extractives. The finished fil- filter milk or potable water at oper- ter, when exposed to 5 percent (by ating temperatures not to exceed 145 weight) acetic acid for 2 hours at a °F, provided that the finished filter temperature equivalent to, or higher when exposed to distilled water at 145 than, the filtration temperature of the °F for 2 hours yields total extractives aqueous food, yields total extractives not to exceed 1.2 percent by weight of not to exceed 4 percent, by weight, of the filter. the filter. (2) Conditions of use. It is used in com- (n) Acrylonitrile copolymers identi- mercial filtration of bulk quantities of fied in this section shall comply with nonalcoholic, aqueous foods having a the provisions of § 180.22 of this chap- pH of 5.0 or below. ter. (k) Resin-bonded filters conforming [42 FR 14572, Mar. 15, 1977, as amended at 56 with the specifications of paragraph (k) FR 42933, Aug. 30, 1991]
313
VerDate 06
§ 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. weight of titanium dioxide as an op- (b) The resin may contain one or tional adjuvant substance. more of the following optional sub- (c) The mineral reinforced nylon res- stances provided the quantity used ins with or without the optional sub- does not exceed that reasonably re- stance described in paragraph (b) of 1 quired to accomplish the intended ef- this section, and in the form of ⁄8-inch fect: molded test bars, when extracted with the solvents, i.e., distilled water and 50 Allyl glycidyl ether ...... As curing system additive. percent (by volume) ethyl alcohol in Di- and tri-glycidyl ester mix- As modifier at levels not to distilled water, at reflux temperature ture resulting from the re- exceed equal parts by for 24 hours using a volume-to-surface action of epichlorohydrin weight of the 4,4′- with mixed dimers and isopropylidenediphenol- ratio of 2 milliliters of solvent per trimers of unsaturated C18 epichlorohydrin basic resin square inch of surface tested, shall monobasic fatty acids de- and limited to use in con- meet the following extractives limita- rived from animal and veg- tact with alcoholic bev- tions: etable fats and oils. erages containing not more than 8 percent of alcohol. (1) Total extractives not to exceed 5.0 1,2-Epoxy-3-phenoxypropane As curing system additive. milligrams per square inch of food-con- Glyoxal ...... Do. tact surface tested for each solvent. ′ 4,4 -Isopropylidenediphenol ... Do. (2) The ash after ignition of the ex- 4,4′-Methylenedianiline ...... Do. m-Phenylenediamine ...... Do. tractives described in paragraph (c)(1) Tetrahydrophthalic anhydride Do. of this section, not to exceed 0.5 milli- gram per square inch of food-contact (c) In accordance with good manufac- surface tested. turing practice, finished articles con- (d) In accordance with good manufac- taining the resins shall be thoroughly turing practice, finished articles con- cleansed prior to their first use in con- taining the mineral reinforced nylon tact with food. resins shall be thoroughly cleansed (d) The provisions of this section are prior to their first use in contact with not applicable to 4,4′-isopropylidenedi- food. phenol-epichlorohydrin resins listed in other sections of parts 174, 175, 176, 177, [42 FR 54533, Oct. 7, 1977, as amended at 42 FR 61594, Dec. 6, 1977] 178 and 179 of this chapter. [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, § 177.2400 Perfluorocarbon cured 1984] elastomers. Perfluorocarbon cured elastomers § 177.2355 Mineral reinforced nylon identified in paragraph (a) of this sec- resins. tion may be safely used as articles or Mineral reinforced nylon resins iden- components of articles intended for re- tified in paragraph (a) of this section peated use in contact with nonacid may be safely used as articles or com- food (pH above 5.0), subject to the pro- ponents of articles intended for re- visions of this section. peated use in contact with nonacidic (a) Identity. (1) For the purpose of food (pH above 5.0) and at use tempera- this section, perfluorocarbon cured tures not exceeding 212 °F. in accord- elastomers are produced by
314
VerDate 06
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- (trifluoromethyl)-ethylidene] bis- Model 1099 with Model 951 TGA unit or ,dipotassium salt—not to exceed 5 parts. the equivalent. 1,4,7,10,13,16-Hexaoxacyclo-octadecane—not (d) Extractive limitations. Articles fab- to exceed 5 parts. ricated from perfluorocarbon cured 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: (1) Substances generally recognized as safe (GRAS) in food or food pack- (1) Total extractives not to exceed 3.1 aging. milligrams per square decimeter (0.2 (2) Substances used in accordance milligrams per square inch). with a prior sanction. (2) Fluoride extractives calculated as (3) Substances authorized under ap- fluorine not to exceed 0.47 milligram plicable regulations in this part and in per square decimeter (0.03 milligram parts 175 and 178 of this chapter and per square inch). subject to any limitations prescribed (e) Conditions of use. In accordance therein. with current good manufacturing prac- (4) Substances identified in this para- tice, finished food contact articles con- graph (b)(4) subject to such limitations taining the perfluorocarbon cured as are provided: elastomers shall be thoroughly cleaned prior to their first use in contact with Substances Limitations food.
Carbon black (channel proc- Not to exceed 15 parts per [49 FR 43050, Oct. 26, 1984] ess of furnace combustion 100 parts of the process) (CAS Reg. No. terpolymer. § 177.2410 Phenolic resins in molded 1333±86±4). Magnesium oxide (CAS Reg. Not to exceed 5 parts per articles. No. 1309±48±4). 100 parts of the Phenolic resins identified in this sec- terpolymer. tion may be safely used as the food-
315
VerDate 06
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 Poly(aryletherketone) resins identi- this section, with or without aniline fied in paragraph (a) of this section and/or anhydro-formaldehyde aniline may be safely used as articles or com- (hexahydro-1, 3,5-triphenyl-s-triazine): ponents of articles intended for re- (1) Phenols: peated use in contact with food subject p-tert-Amylphenol. to the provisions of this section. p-tert-Butylphenol. (a) Identity. For the purposes of this o-, m-, and p-Cresol. section, poly(aryletherketone) resins p-Octylphenol. are poly(p-oxyphenylene p- Phenol. 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 have a minimum weight-average mo- (2) Aldehydes: lecular weight of 12,000, as determined Acetaldehyde. by gel permeation chromatography in Formaldehyde. comparison with polystyrene stand- Paraldehyde. ards, and a minimum mid-point glass (b) Optional adjuvant substances em- transition temperature of 142 °C, as de- ployed in the production of the phe- termined by differential scanning nolic resins or added thereto to impart calorimetry. desired technical or physical properties (b) Optional adjuvant substances. The include the following: basic resins identified in paragraph (a) may contain optional adjuvant sub- Asbestos fiber. stances used in their production. These Barium hydroxide ...... For use as catalyst. Calcium stearate ...... For use as lubricant. adjuvants may include substances de- Carbon black (channel proc- scribed in § 174.5(d) of this chapter and ess). the following: Diatomaceous earth. Glass fiber. Hexamethylenetetramine ...... For use as curing agent. Mica. Oxalic acid ...... For use as catalyst. Substance Limitations Zinc stearate ...... For use as lubricant. Diphenyl sulfone ...... Not to exceed 0.2 percent by weight as a residual (c) The finished food-contact article, solvent in the finished when extracted with distilled water at basic resin. reflux temperature for 2 hours, using a volume-to-surface ratio of 2 milliliters (c) Extractive limitations. The finished of distilled water per square inch of food contact article, when extracted at surface tested, shall meet the following reflux temperatures for 2 hours with extractives limitations: the following four solvents, yields in (1) Total extractives not to exceed each extracting solvent net chloroform 0.15 milligram per square inch of food- soluble extractives not to exceed 0.05 contact surface. milligrams per square inch of food con- (2) Extracted phenol not to exceed tact surface: Distilled water, 50 percent 0.005 milligram per square inch of food- (by volume) ethanol in distilled water, contact surface. 3 percent acetic acid in distilled water, (3) No extracted aniline when tested and n-heptane. In testing the final food by a spectrophotometric method sen- contact article, a separate test sample
316
VerDate 06
shall be used for each extracting sol- Ethylene glycol. vent. Glycerol. 4,4′-Isopropylidenediphenol-epichlorohydrin. [63 FR 20315, Apr. 24, 1998] Mannitol. a-Methyl glucoside. § 177.2420 Polyester resins, cross- Pentaerythritol. linked. Polyoxypropylene ethers of 4,4′-isopropylide- Cross-linked polyester resins may be nediphenol (containing an average of 2–7.5 safely used as articles or components moles of propylene oxide). of articles intended for repeated use in Propylene glycol. contact with food, in accordance with Sorbitol. Trimethylol ethane. the following prescribed conditions: Trimethylol propane. (a) The cross-linked polyester resins 2,2,4-Trimethyl-1,3-pentanediol. are produced by the condensation of one or more of the acids listed in para- (3) Cross-linking agents: graph (a)(1) of this section with one or Butyl acrylate. more of the alcohols or epoxides listed Butyl methacrylate. in paragraph (a)(2) of this section, fol- Ethyl acrylate. lowed by copolymerization with one or Ethylhexyl acrylate. more of the cross-linking agents listed Methyl acrylate. in paragraph (a)(3) of this section: Methyl methacrylate. (1) Acids: Styrene. Triglycidyl isocyanurate (CAS Reg. No. 2451– Adipic. 62–9), for use only in coatings contacting Fatty acids, and dimers thereof, from nat- bulk quantities of dry food of the type ural sources. identified in § 176.170(c) of this chapter, Fumaric. table 1, under type VIII. Isophthalic. Vinyl toluene. Maleic. Methacrylic. (b) Optional adjuvant substances em- Orthophthalic. ployed to facilitate the production of Sebacic. the resins or added thereto to impart Terephthalic. desired technical or physical properties Trimellitic. include the following, provided that (2) Polyols and polyepoxides: the quantity used does not exceed that Butylene glycol. reasonably required to accomplish the Diethylene glycol. intended physical or technical effect 2,2-Dimethyl-1,3-propanediol. and does not exceed any limitations Dipropylene glycol. 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. 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. 818±08±6) ...... For use in the polycondensation reaction at levels not to ex- ceed 0.2 percent of the polyester resin. Dicumyl peroxide.
317
VerDate 06
Limitations (limits of addition expressed as percent by weight List of substances of finished resin)
Hydroxybutyltin oxide (CAS Reg. No. 2273±43±0) ...... 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. 23850± For use in the polycondensation reaction at levels not to ex- 94±4). ceed 0.2 percent of the polyester resin. 4. Solvents for inhibitors, accelerators, and catalysts: Butyl benzyl phthalate (containing not more than 1.0 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, ins shall be thoroughly cleansed prior with or without the optional sub- to their first use in contact with food. stances described in paragraph (b) of [42 FR 14572, Mar. 15, 1977, as amended at 48 this section, and in the finished form in FR 37618, Aug. 19, 1983; 54 FR 48858, Nov. 28, which they are to contact food, when 1989] extracted with the solvent or solvents characterizing the type of food and § 177.2430 Polyether resins, under the conditions of time and tem- chlorinated. perature characterizing the conditions Chlorinated polyether resins may be of their intended use, as determined safely used as articles or components from tables 1 and 2 of § 176.170(c) of this of articles intended for repeated use in chapter, shall meet the following ex- producing, manufacturing, packing, tractives limitations: processing, preparing, treating, pack- (1) Net chloroform-soluble extrac- aging, transporting, or holding food, in tives not to exceed 0.1 milligram per accordance with the following pre- square inch of food-contact surface scribed conditions: tested when the prescribed food-simu- (a) The chlorinated polyether resins lating solvent is water or 8 or 50 per- are produced by the catalytic polym- cent alcohol. erization of 3,3-bis(chloromethyl)- (2) Total nonvolatile extractives not oxetane, and shall contain not more to exceed 0.1 milligram per square inch than 2 percent residual monomer. of food-contact surface tested when the (b) In accordance with good manufac- prescribed food-simulating solvent is turing practice, finished articles con- taining the chlorinated polyether res- heptane. ins shall be thoroughly cleansed prior (d) In accordance with good manufac- to their first use in contact with food. turing practice, finished articles con- taining the cross-linked polyester res- § 177.2440 Polyethersulfone resins. Polyethersulfone resins identified in paragraph (a) of this section may be
318
VerDate 06
safely used as articles or components inch of food-contact surface: distilled of articles intended for repeated use in water, 50 percent (by volume) ethyl al- contact with food in accordance with cohol in distilled water, 3 percent ace- the following prescribed conditions: tic acid in distilled water, and n- (a) For the purpose of this section, heptane. (Note: In testing the finished polyethersulfone resins are: food-contact article, use a separate (1) Poly(oxy-p-phenylenesulfonyl-p- test sample for each required extract- phenylene) resins (CAS Reg. No. 25667– ing solvent.) 42–9), which have a minimum number (d) In accordance with good manufac- average molecular weight of 16,000. turing practice, finished food-contact (2) 1,1′-sulfonylbis[4-chlorobenzene] articles containing the polymer with 4,4′-(1-methylethyl- polyethersulfone resins shall be thor- idene)bis[phenol] (maximum 8 percent) oughly cleansed before their first use and 4,4′-sulfonylbis[phenol] (minimum in contact with food. 92 percent) (CAS Reg. No. 88285–91–0), which have a minimum number aver- [44 FR 34493, June 15, 1979, as amended at 47 FR 38885, Sept. 3, 1982; 49 FR 10111, Mar. 19, age molecular weight of 26,000. 1984; 50 FR 47211, Nov. 15, 1985; 60 FR 48648, (3) In paragraphs (a)(1) and (a)(2) of Sept. 20, 1995] this section, the minimum number av- erage molecular weight is determined § 177.2450 Polyamide-imide resins. by reduced viscosity in dimethyl form- Polyamide-imide resins identified in amide in accordance with ASTM meth- paragraph (a) of this section may be od D2857–70 (Reapproved 1977), ‘‘Stand- safely used as components of articles ard Test Method for Dilute Solution intended for repeated use in contact Viscosity of Polymers,’’ which is incor- with food, in accordance with the fol- porated by reference. Copies may be lowing prescribed conditions: obtained from the American Society (a) Identity. (1) For the purpose of for Testing Materials, 1916 Race St., this section the polyamide-imide resins Philadelphia, PA 19103, or may be ex- are derived from the condensation re- amined at the Division of Petition Con- action of substantially equimolar parts trol (HFS–215), Center for Food Safety of trimellitic anhydride and p,p′- and Applied Nutrition, 1110 Vermont diphenylmethane diisocyanate. Ave. NW., suite 1200, Washington, DC, (2) The polyamide-imide resins (CAS or at the Office of the Federal Register, Reg. No. 31957–38–7) derived from the 800 North Capitol St. NW., suite 700, condensation reaction of equimolar Washington, DC. parts of benzoyl chloride-3,4- (b) The basic resins identified in dicarboxylic anhydride and 4,4′- paragraphs (a)(1) and (a)(2) of this sec- diphenylmethanediamine. tion may contain optional adjuvant (b) Specifications. (1) Polyamide-imide substances described in § 174.5(d) of this resins identified in paragraph (a)(1) of chapter and the following: this section shall have a nitrogen con- List of substances Limitations tent of not less than 7.8 weight percent and not more than 8.2 weight percent. Diphenylsulfone ...... Not to exceed 0.2 percent as re- Polyamide-imide resins identified in sidual solvent in the finished basic resin described in para- paragraph (a)(2) of this section shall graph (a)(1) of this section. have a nitrogen content of not less Dimethyl sulfoxide ...... Not to exceed 0.01 percent as than 7.5 weight percent and not more residual solvent in the finished basic resin described in para- than 7.8 weight percent. Nitrogen con- graph (a)(1) of this section. tent is determined by the Dumas Nitro- N-methyl-2-pyrrolidone ..... Not to exceed 0.01 percent as gen Determination as set forth in the residual solvent in the finished basic resin described in para- ‘‘Official Methods of Analysis of the graph (a)(2) of this section. Association of Official Analytical Chemists,’’ 13th Ed. (1980), sections (c) The finished food-contact article, 7.016–7.020, which is incorporated by when extracted at reflux temperatures reference in accordance with 5 U.S.C. for 2 hours with the following four sol- 552(a). Copies may be obtained from the vents, yields net chloroform-soluble ex- Association of Official Analytical tractives in each extracting solvent Chemists International, 481 North not to exceed 0.02 milligram per square Frederick Ave., suite 500, Gaithersburg,
319
VerDate 06
MD 20877–2504, or may be examined at steel plates, exposed to the respective the Office of the FEDERAL REGISTER, food simulating solvents. The resin 800 North Capitol Street, NW., suite shall meet the following extractive 700, Washington, DC. limitations under the corresponding (2) Polyamide-imide resins identified extraction conditions: in paragraph (a)(1) of this section shall (1) Distilled water at 250 °F for 2 have a solution viscosity of not less hours: Not to exceed 0.01 milligram per than 1.200. Polyamide-imide resins square inch. identified in paragraph (a)(2) of this (2) Three percent acetic acid at 212 °F section shall have a solution viscosity for 2 hours: Not to exceed 0.05 milli- of not less than 1.190. Solution vis- gram per square inch. cosity shall be determined by a method (3) Fifty percent ethyl alcohol at 160 titled ‘‘Solution Viscosity’’ which is in- °F for 2 hours: Not to exceed 0.03 milli- corporated by reference in accordance gram per square inch. with 5 U.S.C. 552(a). Copies are avail- ° 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- [42 FR 14572, Mar. 15, 1977, as amended at 47 diphenylmethane diisocyanate should FR 11845, Mar. 19, 1982; 49 FR 10111, Mar. 19, not be present at greater than 100 parts 1984; 54 FR 24898, June 12, 1989; 54 FR 43170, per million and trimellitic anhydride Oct. 23, 1989; 61 FR 14481, Apr. 2, 1996] should not be present at greater than 500 parts per million. Residual mono- § 177.2460 Poly(2,6-dimethyl-1,4-phen- mers are determined by gas chroma- ylene) oxide resins. tography (the gas chromatography The poly(2,6-dimethyl-1,4-phenylene) method titled ‘‘Amide-Imide Polymer oxide resins identified in paragraph (a) Analysis—Analysis of Monomer Con- of this section may be used as an arti- tent,’’ is incorporated by reference in cle or as a component of an article in- accordance with 5 U.S.C. 552(a). Copies tended for use in contact with food sub- are available from the Center for Food ject to the provisions of this section. Safety and Applied Nutrition (HFS– (a) Identity. For the purposes of this 200), Food and Drug Administration, section, poly(2,6-dimethyl-1,4-phen- 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of ylene) oxide resins consist of basic res- the Federal Register, 800 North Capitol ins produced by the oxidative coupling Street, NW., suite 700, Washington, of 2,6-xylenol such that the finished DC). basic resins meet the specifications (c) Extractive limitations are appli- and extractives limitations prescribed cable to the polyamide-imide resins in paragraph (c) of this section. identified in paragraphs (a) (1) and (2) (b) Optional adjuvant substances. The of this section in the form of films of 1 basic poly(2,6-dimethyl-1,4-phenylene) mil uniform thickness after coating oxide resins identified in paragraph (a) and heat curing at 600 °F for 15 minutes of this section may contain optional on stainless steel plates, each having adjuvant substances required in the such resin-coated surface area of 100 production of such basic resins. The op- square inches. The cured-resin film tional adjuvant substances required in coatings shall be extracted in accord- the production of the basic poly(2,6-di- ance with the method described in methyl-1,4-phenylene) oxide resins may § 176.170(d)(3) of this chapter, using a include substances permitted for such plurality of spaced, coated stainless use by regulations in parts 170 through
320
VerDate 06
189 of this chapter, substances gen- c=Concentration of solution in terms of erally recognized as safe in food, sub- grams per deciliter. stances used in accordance with a prior (2) Extractives limitations. Total resin sanction or approval, and the fol- extracted not to exceed 0.02 weight-per- lowing: cent when extracted with n-heptane at Limitations (expressed as 160 °F for 2 hours as determined using List of substances percent by weight of finished 200 milliliters of reagent grade n- basic resin) heptane which has been freshly dis- Diethylamine ...... Not to exceed 0.16 percent tilled before use and 25 grams of poly as residual catalyst. (2,-6-dimethyl-1,4-phenylene) oxide Methyl alcohol ...... Not to exceed 0.02 percent as residual solvent. resin. The resin as tested is in pellet Toluene ...... Not to exceed 0.2 percent as form having a particle size such that residual solvent. 100 percent of the pellets will pass through a U.S. Standard Sieve No. 6 (c) Specifications and extractives limita- and 100 percent of the pellets will be tions. The poly(2,6-dimethyl-1,4-phen- held on a U.S. Standard Sieve No. 10. ylene) oxide basic resins meet the fol- (d) Other limitations. The poly(2,6-di- lowing: methyl-1,4-phenylene) oxide resins (1) Specifications. Intrinsic viscosity identified in and complying with this is not less than 0.30 deciliter per gram section, when used as components of as determined by ASTM method D1243– the food-contact surface of any article 79, ‘‘Standard Test Method for Dilute that is the subject of a regulation in Solution Viscosity of Vinyl Chloride parts 174, 175, 176, 177, 178 and § 179.45 of Polymers,’’ which is incorporated by this chapter, shall comply with any reference, modified as follows. Copies specifications and limitations pre- of the incorporation by reference may scribed by such regulation for the arti- be obtained from the American Society cle in the finished form in which it is for Testing Materials, 1916 Race St., to contact food. Philadelphia, PA 19103, or may be ex- (e) Uses. The poly(2,6-dimethyl-1,4- amined at the Office of the Federal phenylene) oxide resins identified in Register, 800 North Capitol Street, and complying with the limitations in NW., suite 700, Washington, DC 20408. this section may be used as articles or (i) Solvent: Chloroform, reagent grade components of articles intended for re- containing 0.01 percent tert- peated food-contact use or as articles butylcatechol. (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 (iii) Viscometer: Cannno-Ubbelohde se- § 176.170(c) of this chapter, table 2, con- ries 25 dilution viscometer (or equiva- ditions of use H. lent). [42 FR 14572, Mar. 15, 1977, as amended at 49 (iv) Calculation: The calculation FR 10111, Mar. 19, 1984; 63 FR 8852, Feb. 23, method used is that described in appen- 1998] dix X.1.3 (ASTM method D1243–79, cited and incorporated by reference in para- § 177.2465 Polymethylmethacrylate/ graph (c)(1) of this section) with the re- poly(trimethoxysilylpropyl)meth- duced viscosity determined for three acrylate copolymers. concentration levels (0.4, 0.2, and 0.1 Polymethylmethacrylate/ gram per deciliter) and extrapolated to poly(trimethoxysilylpropyl) methacry- zero concentration for intrinisic vis- late copolymers (CAS Reg. No. 26936– cosity. The following formula is used 30–1) may be safely used as components for determining reduced viscosity: of surface primers used in conjunction with silicone polymers intended for re- − Reduced viscosity in terms = t to peated use and complying with § 175.300 of deciliters per gram × of this chapter and § 177.2600, in accord- to c ance with the following prescribed con- where: ditions. t=Solution efflux time. (a) Identity. For the purpose of this to=Solvent efflux time. section, polymethylmethacrylate/
321
VerDate 06
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- not to exceed 6.0 percent by weight of phenol). the primer formulation. Nylon 6/66, weight ratio 2/3. (2) The copolymers may be used in Tetrakis [methylene (3,5-di-tert-butyl-4- food contact applications with all food hydroxyhydrocinnamate)] methane. 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- [59 FR 5948, Feb. 9, 1994] ylene copolymer can be identified by its characteristic infrared spectrum. § 177.2470 Polyoxymethylene copoly- (2) Minimum number average molec- mer. ular weight of the copolymer is 15,000 Polyoxymethylene copolymer identi- as determined by a method titled fied in this section may be safely used ‘‘Number Average Molecular Weight,’’ as an article or component of articles which is incorporated by reference. intended for food-contact use in ac- Copies are available from the Center cordance with the following prescribed for Food Safety and Applied Nutrition conditions: (HFS–200), Food and Drug Administra- (a) Identity. For the purpose of this tion, 200 C St. SW., Washington, DC section, polyoxymethylene copolymers 20204, or available for inspection at the are identified as the following: The re- Office of the Federal Register, 800 action product of trioxane (cyclic North Capitol Street, NW., suite 700, trimer of formaldehyde) and ethylene Washington, DC 20408. oxide (CAS Reg. No. 24969–25–3) or the (d) Extractive limitations. (1) Polyoxy- reaction product of trioxane (cyclic methylene copolymer in the finished trimer of formaldehyde) and a max- form in which it is to contact food, imum of 5 percent by weight of when extracted with the solvent or sol- butanediol formal (CAS Reg. No. 25214 vents characterizing the type of food 85–1). Both copolymers may have cer- and under conditions of time and tem- tain optional substances added to im- perature as determined from tables 1 part desired technological properties to and 2 of § 175.300(d) of this chapter, the copolymer. shall yield net chloroform-soluble ex- (b) Optional adjuvant substances. The tractives not to exceed 0.5 milligram polyoxymethylene copolymer identi- per square inch of food-contact surface. fied in paragraph (a) of this section (2) Polyoxymethylene copolymer may contain optional adjuvant sub- with or without the optional sub- stances required in its production. The stances described in paragraph (b) of quantity of any optional adjuvant sub- this section, when ground or cut into stance employed in the production of particles that pass through a U.S.A. the copolymer does not exceed the Standard Sieve No. 6 and that are re- amount reasonably required to accom- tained on a U.S.A. Standard Sieve No. plish the intended technical or physical 10, shall yield total extractives as fol- effect. Such adjuvants may include lows: substances generally recognized as safe (i) Not to exceed 0.20 percent by in food, substances used in accordance weight of the copolymer when ex- with prior sanction, substances per- tracted for 6 hours with distilled water mitted under applicable regulations in at reflux temperature. parts 170 through 189 of this chapter, (ii) Not to exceed 0.15 percent by and the following: weight of the copolymer when ex- (1) Stabilizers (total amount of stabi- tracted for 6 hours with n-heptane at lizers not to exceed 2.0 percent and reflux temperature.
322
VerDate 06
(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- (2) Use temperature shall not exceed 35074±77±2). cles shall not be used for ° 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 turing practice, finished articles con- tert-butylphenol). percent by weight of 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 be identified by its characteristic in- accordance with the following pre- frared spectrum. scribed conditions: (2) Minimum number average molec- (a) Identity. For the purpose of this ular weight of the homopolymer is section, polyoxymethylene homopoly- 25,000. mer is polymerized formaldehyde (3) Density of the homopolymer is be- [Chemical Abstracts Service Registry tween 1.39 and 1.44 as determined by No. 9002–81–7]. Certain optional adju- ASTM method D1505–68 (Reapproved vant substances, described in para- 1979), ‘‘Standard Test Method for Den- graph (b) of this section, may be added sity of Plastics by the Density-Gra- to impart desired technological prop- dient Technique,’’ which is incor- erties to the homopolymer. porated by reference. Copies may be (b) Optional adjuvant substances. The obtained from the American Society polyoxymethylene homopolymer iden- for Testing Materials, 1916 Race St., tified in paragraph (a) of this section Philadelphia, PA 19103, or may be ex- may contain optional adjuvant sub- amined at the Office of the Federal stances in its production. The quantity Register, 800 North Capitol Street, of any optional adjuvant substance em- NW., suite 700, Washington, DC 20408. ployed in the production of the (4) Melting point is between 172 °C homopolymer does not exceed the and 184 °C as determined by ASTM amount reasonably required to accom- method D2133–66, ‘‘Specifications for plish the intended effect. Such adju- Acetal Resin Injection Molding and Ex- vants may include substances gen- trusion Materials’’ (Revised 1966), erally recognized as safe in food, sub- which is incorporated by reference. stances used in accordance with prior Copies are available from American So- sanction, substances permitted under ciety for Testing and Materials applicable regulations in this part, and (ASTM), 1916 Race Street, Philadel- the following: phia, PA 19103, or available for inspec- (1) Stabilizers. The homopolymer may tion at the Office of the Federal Reg- contain one or more of the following ister, 800 North Capitol Street, NW., stabilizers. The total amount of stabi- suite 700, Washington, DC 20408. lizers shall not exceed 1.9 percent of (d) Extractive limitations. (1) homopolymer by weight, and the quan- Polyoxymethylene homopolymer, in tity of individual stabilizer used shall the finished form which is to contact not exceed the limitations set forth food, when extracted with the solvent below: or solvents characterizing the type of
323
VerDate 06
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 articles or components of articles in- required to accomplish the intended tended for repeated use. physical or technical effect. (2) Use temperature shall not exceed (1) Substances generally recognized 250 °F. as safe in food. (3) In accordance with good manufac- (2) Substances used in accordance turing practice, finished articles con- with prior sanction or approval. taining polyoxymethylene (3) Substances the use of which is homopolymer shall be thoroughly permitted in coatings under regula- cleansed prior to first use in contact tions in parts 170 through 189 of this with food. chapter. [42 FR 14572, Mar. 15, 1977, as amended at 43 (c) The finished coatings are ther- FR 44835, Sept. 29, 1978; 47 FR 11846, Mar. 19, mally cured at temperatures of 700 °F 1982; 47 FR 51562, Nov. 16, 1982; 49 FR 10111, and above. Mar. 19, 1984; 54 FR 24898, June 12, 1989] (d) Polyphenylene sulfide resin coat- ings may be used in contact with food § 177.2490 Polyphenylene sulfide res- at temperatures not to exceed the boil- ins. ing point of water; provided that the Polyphenylene sulfide resins finished cured coating, when extracted (poly(1,4-phenylene sulfide) resins) may at reflux temperatures for 8 hours sepa- be safely used as coatings or compo- rately with distilled water, 50 percent
324
VerDate 06
ethanol in water, and 3 percent acetic rate test sample for each required ex- acid, yields total extractives in each tracting solvent.) extracting solvent not to exceed 0.02 (c) In accordance with good manufac- milligram per square inch of surface turing practice, finished food-contact and when extracted at reflux tempera- articles containing the polyvinylidene ture for 8 hours with heptane yields fluoride resins shall be thoroughly total extractives not to exceed 0.1 mil- cleansed prior to their first use in con- ligram per square inch of surface. tact with food. (e) Polyphenylene sulfide resin coat- ings containing perfluorocarbon resins § 177.2550 Reverse osmosis mem- branes. complying with § 177.1550 may be used in contact with food at temperatures Substances identified in paragraph up to and including normal baking and (a) of this section may be safely used as frying temperatures; provided that the reverse osmosis membranes intended finished cured coating, when extracted for use in processing bulk quantities of at reflux temperatures for 2 hours sepa- liquid food to separate permeate from rately with distilled water, 50 percent food concentrate or in purifying water ethanol in water, 3 percent acetic acid for food manufacturing under the fol- and heptane, yields total extractives in lowing prescribed conditions: each extracting solvent not to exceed (a) Identity. For the purpose of this 0.2 milligram per square inch of surface section, reverse osmosis membranes and when extracted at reflux tempera- may consist of either of the following ture for 1 hour with diphenyl ether formulations: yields total extractives not to exceed (1) A cross-linked high molecular 4.5 milligrams per square inch of sur- weight polyamide reaction product of face. 1,3,5-benzenetricarbonyl trichloride with 1,3-benzenediamine (CAS Reg. No. [42 FR 14572, Mar. 15, 1977, as amended at 47 83044–99–9) or piperazine (CAS Reg. No. FR 11846, Mar. 19, 1982; 54 FR 24898, June 12, 110–85–0). The membrane is on the food- 1989] contact surface, and its maximum weight is 62 milligrams per square deci- § 177.2510 Polyvinylidene fluoride res- meter (4 milligrams per square inch) as ins. a thin film composite on a suitable Polyvinylidene fluoride resins may support. be safely used as articles or compo- (2) A cross-linked polyetheramine nents of articles intended for repeated (CAS Reg. No. 101747–84–6), identified as use in contact with food, in accordance the copolymer of epichlorohydrin, 1,2- with the following prescribed condi- ethanediamine and 1,2-dichloroethane, tions: whose surface is the reaction product (a) For the purpose of this section, of this copolymer with 2,4- the polyvinylidene fluoride resins con- toluenediisocyanate (CAS Reg. No. of sist of basic resins produced by the po- the final polymer is 99811–80–0) for use lymerization of vinylidene fluoride. as the food-contact surface of reverse (b) The finished food-contact article, osmosis membranes used in processing when extracted at reflux temperatures liquid food. The composite membrane for 2 hours with the solvents distilled is on the food-contact surface and its water, 50 percent (by volume) ethyl al- maximum weight is 4.7 milligrams per cohol in distilled water, and n-heptane, square decimeter (0.3 milligrams per yields total extractives in each ex- square inch) as a thin film composite tracting solvent not to exceed 0.01 mil- on a suitable support. The maximum ligram per square inch of food-contact weight of the 2,4-toluenediisocyanate surface tested; and if the finished food- component of the thin film composite contact article is itself the subject of a is 0.47 milligrams per square decimeter regulation in parts 174, 175, 176, 177, 178 (0.03 milligrams per square inch). and § 179.45 of this chapter, it shall also (3) For the purpose of this section, comply with any specifications and the reverse osmosis membrane consists limitations prescribed for it by that of a polyaramide identified as 2,4- regulation. (NOTE: In testing the fin- diaminobenzenesulfonic acid, calcium ished food-contact article, use a sepa- salt (2:1) polymer with 1,3-
325
VerDate 06
benzenediamine, 1,3-benzenedicarbonyl (2) Reverse osmosis membranes de- dichloride, and 1,4-benzenedicarbonyl scribed in paragraph (a)(4) of this sec- dichloride (CAS Reg. No. 39443–76–0). tion may be used in contact with all The membrane is the food contact sur- types of liquid food, except food con- face and may be applied as a film on a taining more than 8 percent alcohol, at suitable support. Its maximum weight temperatures up to 80 °C (176 °F). is 512 milligrams per square decimeter (3) Reverse osmosis membranes shall (33 milligrams per square inch). be maintained in a sanitary manner in (4) A cross-linked high molecular accordance with current good manufac- weight polyamide reaction product of turing practice so as to prevent micro- poly(N-vinyl-N-methylamine) (CAS bial adulteration of food. Reg. No. 31245–56–4), N,N′-bis(3- aminopropyl)ethylenediamine (CAS (4) To assure their safe use, reverse Reg. No. 10563–26–5), 1,3- osmosis membranes and their supports benzenedicarbonyl dichloride (CAS shall be thoroughly cleaned prior to Reg. No. 99–63–8) and 1,3,5- their first use in accordance with cur- benzenetricarbonyl trichloride (CAS rent good manufacturing practice. Reg. No. 4422–95–1). The membrane is [49 FR 49448, Dec. 20, 1984, as amended at 52 the food-contact surface. Its maximum FR 29668, Aug. 11, 1987; 53 FR 31835, Aug. 22, weight is 20 milligrams per square deci- 1988; 53 FR 32215, Aug. 24, 1988; 55 FR 8139, meter (1.3 milligrams per square inch) Mar. 7, 1990; 59 FR 9925, Mar. 2, 1994] as a thin film composite on a suitable support. § 177.2600 Rubber articles intended for (5) A polyamide reaction product of repeated use. 1,3,5-benzenetricarbonyl trichloride Rubber articles intended for repeated polymer (CAS Reg. No. 4422–95–1) with use may be safely used in producing, piperazine (CAS Reg. No. 110–85–0) and manufacturing, packing, processing, 1,2-diaminoethane (CAS Reg. No. 107– preparing, treating, packaging, trans- 15–3). The membrane is the food-con- porting, or holding food, subject to the tact layer and may be applied as a film provisions of this section. on a suitable support. Its maximum weight is 15 milligrams per square deci- (a) The rubber articles are prepared meter (1 milligram per square inch). from natural and/or synthetic polymers (b) Optional adjuvant substances. The and adjuvant substances as described basic polymer identified in paragraph in paragraph (c) of this section. (a) of this section may contain optional (b) The quantity of any substance adjuvant substances required in the employed in the production of rubber production of such basic polymer. articles intended for repeated use shall These optional adjuvant substances not exceed the amount reasonably re- may include substances permitted for quired to accomplish the intended ef- such use by regulations in parts 170 fect in the rubber article and shall not through 186 of this chapter, substances be intended to accomplish any effect in generally recognized as safe in food, food. and substances used in accordance with (c) Substances employed in the prep- a prior sanction or approval. aration of rubber articles include the (c) Supports. Suitable supports for re- following, subject to any limitations verse osmosis membranes are mate- prescribed: rials permitted for such use by regula- (1) Substances generally recognized tions in parts 170 through 186 of this as safe for use in food or food pack- chapter, substances generally recog- aging. nized as safe in food, and substances used in accordance with a prior sanc- (2) Substances used in accordance tion or approval. with the provisions of a prior sanction (d) Conditions of use. (1) Reverse os- or approval. mosis membranes described in para- (3) Substances that by regulation in graphs (a)(1), (a)(2), (a)(3), and (a)(5) of parts 170 through 189 of this chapter this section may be used in contact may be safely used in rubber articles, with all types of liquid food at tem- subject to the provisions of such regu- peratures up to 80 °C (176 °F). lation.
326
VerDate 06
(4) Substances identified in this para- tact with foods of Types I, II, III, IV, V, VI, graph (c)(4), provided that any sub- VII, VIII, and IX identified in table 1 of stance that is the subject of a regula- § 176.170(c) of this chapter at temperatures not to exceed 150 °F except that those co- tion in parts 174, 175, 176, 177, 178 and polymers prepared with less than 50 § 179.45 of this chapter conforms with weight-percent of polyamide are limited to any specification in such regulation. use in contact with such foods at tempera- (i) Elastomers. tures not to exceed 100 °F. Polybutadiene. Acrylonitrile-butadiene copolymer. Polyester elastomers derived from the reac- Brominated isobutylene-isoprene copolymers tion of dimethyl terephthalate, 1,4- complying with § 177.1210. butanediol, and α-hydro-omega- Butadiene-acrylonitrile-ethylene glycol hydroxypoly (oxytetramethylene). Addi- dimethacrylate copolymers containing not tionally, trimethyl trimellitate may be more than 5 weight percent of polymer used as a reactant. The polyester units derived from ethylene glycol elastomers may be used only in contact dimethacrylate. with foods containing not more than 8 per- Butadiene-acrylonitrile-methacrylic acid co- cent alcohol and limited to use in contact polymer. with food at temperatures not exceeding Butadiene-styrene-methacrylic acid copoly- 150 °F. mer. Polyisoprene. Chloroprene polymers. Polyurethane resins (CAS Reg. Nos. 37383–28– Chlorotrifluoroethylene-vinylidene fluoride 1 or 9018–04–6) derived from the reaction of copolymer. diphenylmethane diisocyanate with 1,4- Ethylene-propylene copolymer elastomers butanediol and polytetramethylene ether which may contain not more than 5 glycol. weight-percent of total polymer units de- Polyurethane resins derived from reactions rived from 5-methylene-2-norbornene and/ of diphenylmethane diisocyanate with or 5-ethylidine-2-norbornene. adipic acid and 1,4-butanediol. Ethylene-propylene-dicyclopentadiene co- Rubber, natural. polymer. Silicone basic polymer as described in ASTM Ethylene-propylene-1,4-hexadiene copoly- method D1418–81, ‘‘Standard Practice for mers containing no more than 8 weight Rubber and Rubber Latices—Nomen- percent of total polymer units derived clature,’’ which is incorporated by ref- from 1,4-hexadiene. erence. Copies may be obtained from the Hydrogenated butadiene/acrylonitrile co- American Society for Testing Materials, polymers (CAS Reg. No. 88254–10–8) pro- 1916 Race St., Philadelphia, PA 19103, or duced when acrylonitrile/butadiene copoly- may be examined at the Office of the Fed- mers are modified by hydrogenation of the eral Register, 800 North Capitol Street, olefinic unsaturation to leave not more NW., suite 700, Washington, DC 20408. than 10 percent trans olefinic unsaturation and no α,β-olefinic unsaturation as deter- Silicone (Si) elastomers containing methyl mined by a method entitled ‘‘Determina- groups. tion of Residual α,β-Olefinic and Trans Ole- Silicone (Psi) elastomers containing meth- finic Unsaturation Levels in HNBR,’’ de- yl and phenyl groups. Silicone (Vsi) elastomers containing meth- veloped October 1, 1991, by Polysar Rubber yl and vinyl groups. Corp., 1256 South Vidal St., Sarnia, On- Silicone (Fsi) elastomers containing meth- tario, Canada N7T 7MI, which is incor- yl and fluorine groups. porated by reference in accordance with 5 Silicone (PVsi) elastomers containing U.S.C. 552(a) and 1 CFR part 51. Copies may phenyl, methyl, and vinyl groups. be obtained from the Center for Food Safe- ty and Applied Nutrition (HFS–200), Food Styrene-butadiene copolymer. and Drug Administration, 200 C St. SW., Vinylidene fluoride-hexafluoropropylene co- Washington, DC 20204, or may be examined polymers (minimum number average mo- at the Office of the Federal Register, 800 lecular weight 70,000 as determined by os- North Capitol St. NW., suite 700, Wash- motic pressure in methyl ethyl ketone). ington, DC. 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- (ii) Vulcanization materials—(a) Vul- col). The polyamide and polyether compo- canizing agents. nents are reacted in ratios such that the 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
327
VerDate 06
fluoridehexafluoropropylene copolymer Dicumyl peroxide. and vinylidene fluoride- N,N-Dimethylcyclohexylamine salt of hexafluoropropylene-tetrafluoroethylene dibutyldithiocarbamic acid. copolymer elastomers identified under 2,6-Dimethylmorpholine thiobenzothiazol. paragraph (c)(4)(i) of this section and lim- Dipentamethylenethiuram hexasulfide (CAS ited to use at levels not to exceed 2.4 per- Reg. No. 971–15–3). cent by weight of such copolymers. Diphenylguanidine. Diisopropyl xanthogen polysulfide (a 1:2:1 Diphenylguanidine phthalate. mixture of O,O-di(1-methylethyl)trithio- 1,3-Diphenyl-2-thiourea. bis-thioformate, O,O-di(1- 2,2′-Dithiobis[benzothiazole]. methylethyl)tetrathio-bis-thioformate, 4,4′-Dithiodimorpholine. and O,O-di(1-methylethyl)pentathio-bis- N,N′-Di-o-tolylguanidine. thioformate) for use as a cross linking Di-o-tolylguanidine salt of agent in the vulcanization of natural rub- pyrocatecholborate. ber, styrene-butadiene copolymer, acrylo- Ethylenediamine carbamate. nitrile-butadiene copolymer, and ethylene- Heptaldehyde-aniline resin (iodine number propylene terpolymers identified under 430–445). paragraph (c)(4)(i) of this section and lim- Hexamethylenetetramine. ited to use at levels not to exceed 2.4 per- 2-Mercaptobenzothiazole. cent by weight of such copolymers. 2-Mercaptothiazoline. Hexamethylenediamine carbamate for use N-Oxydiethylene-benzothiazole-2- only as cross-linking agent in the vul- sulfenamide. canization of vinylidene fluoride- Piperidinium pentamethylenedithiocarba- hexafluoropropylene copolymer and vinyli- mate. dene fluoride-hexafluoropropylene-tetra- Potassium pentamethylenedithiocarbamate. fluoroethylene copolymer elastomers iden- p-Quinone dioxime. tified under paragraph (c)(4)(i) of this sec- Sodium dibutyldithiocarbamate. tion and limited to use at levels not to ex- Sodium dimethyldithiocarbamate. ceed 1.5 percent by weight of such copoly- Stannous oleate for use only as an accel- mers. erator for silicone elastomers. Sulfur, ground. Tetrabutylthiuram monosulfide. Tetraethylthiuram disulfide. (b) Accelerators (total not to exceed 1.5 (1,1,4,4-Tetramethyltetramethylene)bis [tert- percent by weight of rubber product). butyl peroxide]. Tetramethylthiuram monosulfide. 2-Benzothiazyl-N,N-diethylthiocarbamyl-sul- Thiram (tetramethylthiuram disulfide). fide. Triallyl cyanurate. Benzoyl peroxide. Triethylenetetramine. 1,3-Bis(2-benzothiazolylmercaptomethyl) 1,3,5-Triethyl-hexahydro-s-triazine urea. (triethyltrimethylenetriamine). N-tert-Butyl-2-benzothiazole sulfenamide. Triphenylguanidine. Butyraldehyde-aniline resin (iodine number Zinc butyl xanathate. 670–705). Zinc dibenzyl dithiocarbamate. Carbon disulfide-1,1′-methylenedipiperidine Zinc dibutyldithiocarbamate. reaction product. Zinc diethyldithiocarbamate. Copper dimethyldithiocarbamate. Zinc 2-mercaptobenzothiazole. N-Cyclohexyl-2-benzothiazole sulfenamide. Ziram (zinc dimethyldithiocarbamate). Dibenzoyl-p-quinone dioxime. Dibenzylamine. (c) Retarders (total not to exceed 10 per- Diisopropyl xanthogen polysulfide (a 1:2:1 cent of weight of rubber product). mixture of O,O-di(1-methylethyl)trithio- Cyanoguanidine. bis-thioformate, O,O-di(1- Phthalic anhydride. methylethyl)tetrathio-bis-thioformate, Salicylic acid. and O,O-di(1-methylethyl)pentathio-bis- thioformate). (d) Activators (total not to exceed 5 per- Di(4-methylbenzoyl) peroxide (CAS Reg. No. cent by weight of rubber product except 895–85–2) for use only as a crosslinking magnesium oxide may be used at higher agent in silicone polymers and elastomers levels). identified under paragraph (c)(4)(i) of this section at levels not to exceed 1 percent by Diethylamine. weight of such polymers and elastomers Fatty acid amines, mixed. where the total of all accelerators does not Fatty acids. exceed 1.5 percent by weight of rubber Magnesium carbonate. product. Magnesium oxide, light and heavy. Di-tert-butyl peroxide. Oleic acid, dibutylamine salt Dibutyl xanthogen disulfide. (dibutylammonium oleate). 2,4-Dichlorobenzoyl peroxide. Stannous chloride.
328
VerDate 06
Tall oil fatty acids. Styrenated phenol. Tetrachloro-p-benzoquinone. 4,4′-Thiobis (6-tert-butyl-m-cresol). Triethanolamine. Toluene-2,4-diamine. Zinc salts of fatty acids. N-o-Tolyl-N′-phenyl-p-phenylenediamine. p(p-Tolylsufanilamide) diphenylamine. (iii) Antioxidants and antiozonants Tri(mixed mono- and dinonylphenyl) (total not to exceed 5 percent by weight of phosphite. rubber product). Tri(nonylphenyl) phosphite-formaldehyde Aldol-a-naphthylamine. resins produced when 1 mole of tri(nonylphenyl) phosphite is made to Alkylated (C4 and/or C8) phenols. BHT (butylated hydroxytoluene). react with 1.4 moles of formaldehyde or 4-[[4,6-bis(octylthio)-s-triazin-2-yl]amino]- produced when 1 mole of nonylphenol is 2,6-di-tert-butylphenol (CAS Reg. No. 991– made to react with 0.36 mole of formalde- 84–4) for use only as a stabilizer at levels hyde and the reaction product is then fur- not to exceed 0.5 percent by weight of the ther reacted with 0.33 mole of phosphorus finished rubber product. trichloride. The finished resins have a min- Butylated reaction product of p-cresol and imum viscosity of 20,000 centipoises at 25 dicyclopentadiene as identified in °C, as determined by LV–series Brookfield § 178.2010(b) of this chapter. viscometer (or equivalent) using a No. 4 Butylated, styrenated cresols identified in spindle at 12 r.p.m., and have an organic § 178.2010(b) of this chapter. phosphorus content of 4.05 to 4.15 percent 4,4′-Butylidinebis(6-tert-butyl-m-cresol). by weight. N-Cyclohexyl-N′-phenylphenylenediamine. (iv) Plasticizers (total not to exceed 30 p,p′-Diaminodiphenylmethane. 2,5-Di-tert-amylhydroquinone. percent by weight of rubber product un- Diaryl-p-phenylenediamine, where the aryl less otherwise specified). group may be phenyl, tolyl, or xylyl. n-Amyl n-decyl phthalate. 2,6-Di-tert-butyl-p-phenylphenol. Butylacetyl ricinoleate. 1,2-Dihydro-2,2,4-trimethyl-6- n-Butyl ester of tall oil fatty acids. dodecylquinoline. Butyl laurate. 1,2-Dihydro-2,2,4-trimethyl-6- Butyl oleate. ethoxyquinoline. Butyl stearate. 1,2-Dihydro-2,2,4-trimethyl-6- Calcium stearate. phenylquinoline. Castor oil. ′ 4,4 -Dimethoxydiphenylamine. Coumarone-indene resins. 4,6-Dinonyl-o-cresol. 2,2′-Dibenzamidodiphenyl disulfide. N,N′-Dioctyl-p-phenylenediamine. Dibenzyl adipate. Diphenylamine-acetone resin. Dibutoxyethoxyethyl adipate. Diphenylamine-acetone-formaldehyde resin. Dibutyl phthalate. N,N′-Diphenylethylenediamine. N,N′-Disalicylalpropylenediamine. Dibutyl sebacate. N,N′-Di-o-tolylethylenediamine. Didecyl adipate. Hydroquinone monobenzyl ether. Didecyl phthalate. Isopropoxydiphenylamine. Diisodecyl adipate. N-Isopropyl-N′-phenyl-p-phenylenediamine. Diisodecyl phthalate. 2,2′-Methylenebis(6-tert-butyl-4-ethylphenol). Diisooctyl adipate. 2,2′-Methylenebis(4-methyl-6-tert-butyl- Diisooctyl sebacate. phenol). Dioctyl adipate. 2,2′-Methylenebis(4-methyl-6-nonylphenol). Dioctyl phthalate. 2,2′-Methylenebis(4-methyl-6-tert- Dioctyl sebacate. octylphenol). Dipentene resin. Monooctyl- and dioctyldiphenylamine. Diphenyl ketone. N,N′-Di-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
329
VerDate 06
section, in contact with foods of Types I, Polyethylene. II, III, IV, VI, VII, VIII, and IX idenified in Sodium stearate. table 1 of § 176.170(c) of this chapter. Montan wax. (viii) Emulsifiers. n-Octyl n-decyl adipate. Fatty acid salts, sodium or potassium. n-Octyl n-decyl phthalate. Naphthalene sulfonic acid-formaldehyde con- Petrolatum. densate, sodium salt. Petroleum hydrocarbon resin Rosins and rosin-derivatives identified in (cyclopentadiene type), hydrogenated. § 175.105(c)(5) of this chapter. Petroleum hydrocarbon resin (produced by Sodium decylbenzenesulfonate the homo- and copolymerization of dienes Sodium dodecylbenzenesulfonate and olefins of the aliphatic, alicyclic, and Sodium lauryl sulfate. monobenzenoid arylalkene types from dis- Tall oil mixed soap (calcium, potassium, and tillates of cracked petroleum stocks). sodium). Petroleum hydrocarbon resin (produced by the catalytic polymerization and subse- (ix) Miscellaneous (total not to exceed 5 quent hydrogenation of styrene, percent by weight of rubber product). vinyltoluene, and indene types from dis- Animal glue as described in § 178.3120 of this tillates of cracked petroleum stocks). chapter. Petroleum oil, sulfonated. Azodicarbonamide as chemical blowing Phenol-formaldehyde resin. agent. Pine tar. 2-Anthraquinone sulfonic acid sodium salt Polybutene. for use only as polymerization inhibitor in Polystyrene. chloroprene polymers and not to exceed Propylene glycol. 0.03 percent by weight of the chloroprene n-Propyl ester of tall oil fatty acids. polymers. Rapeseed oil vulcanized with rubber maker’s 1,2-Benzisothiazolin-3-one (CAS Reg. No. sulfur. 2634–33–5) for use as a biocide in uncured Rosins and rosin derivatives identified in liquid rubber latex not to exceed 0.02 per- § 175.105(c)(5) of this chapter. cent by weight of the latex solids, where Soybean oil vulcanized with rubber maker’s the total of all items listed in paragraph sulfur. (c)(4)(ix) of this section does not exceed 5 Styrene-acrylonitrile copolymer. percent of the rubber product. Terpene resins. n-Butyllithium for use only as polymeriza- Triethylene glycol dicaprate. tion catalyst for polybutadiene. Triethylene glycol dicaprylate. 4-tert-Butyl-o-thiocresol as peptizing agent. Waxes, petroleum. tert-Butyl peracetate. Xylene (or toluene) alkylated with p-tert-Butylpyrocatechol. dicyclopentadiene. ¥ Dialkyl (C8 C18 Zinc 2-benzamidothiophenate. Di- and triethanolamine. (v) Fillers. Diethyl xanthogen disulfide. 4-(Diiodomethylsulfonyl) toluene, Chemical Aluminum hydroxide. Abstracts Service Registry No. 20018–09–01, Aluminum silicate. for use as an antifungal preservative at Asbestos fiber, chrysotile or crocidolite. levels not to exceed 0.3 percent by weight Barium sulfate. of the sealants and caulking materials. Carbon black (channel process or furnace Dodecyl mercaptan isomers, single or mixed. combustion process; total carbon black not 2-Ethoxyethanol. to exceed 50 percent by weight of rubber Iodoform. product; furnace combustion black content p-Menthane hydroperoxide. not to exceed 10 percent by weight of rub- a-(p-Nonylphenyl)-omega-hydroxypoly (oxy- ber products intended for use in contact ethylene) mixture of dihydrogen phosphate with milk or edible oils). and monohydrogen phosphate esters, bar- Cork. ium salt; the nonyl group is a propylene Cotton (floc, fibers, fabric). trimer isomer and the poly (oxyethylene) Mica. content averages 9 moles; for use only as Nylon (floc, fibers, fabric). residual polymerization emulsifier at lev- Silica. els not to exceed 0.7 percent by weight of Titanium dioxide. ethylene-propylene-1,4-hexadiene copoly- Zinc carbonate. mers identified under paragraph (c)(4)(i) of Zinc sulfide. this section. 4,4′-Oxybis (benzenesulfonhydrazide) as (vi) Colorants. Colorants used in ac- 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.
330
VerDate 06
Sodium polysulfide. § 177.2710 Styrene-divinylbenzene res- Sodium nitrite. ins, cross-linked. Sodium salt of ethylenediamine tetraacetic acid and glycine. Styrene-divinylbenzene cross-linked Sodium sulfide. copolymer resins may be safely used as Styrene monomer. articles or components of articles in- Tall oil. tended for repeated use in producing, Thioxylenois as peptizing agents. manufacturing, packing, processing, Tridecyl mercaptan. preparing, treating, packaging, trans- Zinc 4-tert-butylthiophenate as peptizing agent. porting, or holding food, in accordance with the following prescribed condi- (d) Rubber articles intended for use tions: with dry food are so formulated and (a) The resins are produced by the co- cured under conditions of good manu- polymerization of styrene with facturing practice as to be suitable for divinylbenzene. repeated use. (b) The resins meet the extractives (e) Rubber articles intended for re- limitations prescribed in this para- peated use in contact with aqueous graph: food shall meet the following specifica- (1) The resins to be tested are ground tions: The food-contact surface of the or cut into small particles that will rubber article in the finished form in pass through a U.S. standard sieve No. which it is to contact food, when ex- 3 and that will be held on a U.S. stand- tracted with distilled water at reflux ard sieve No. 20. temperature, shall yield total extrac- (2) A 100-gram sample of the resins, tives not to exceed 20 milligrams per when extracted with 100 milliliters of square inch during the first 7 hours of ethyl acetate at reflux temperature for extraction, nor to exceed 1 milligram 1 hour, yields total extractives not to per square inch during the succeeding 2 exceed 1 percent by weight of the res- hours of extraction. ins. (f) Rubber articles intended for re- (c) In accordance with good manufac- peated use in contact with fatty foods turing practice, finished articles con- shall meet the following specifications: taining the resins shall be thoroughly The food-contact surface of the rubber cleansed prior to their first use in con- article in the finished form in which it tact with food. is to contact food, when extracted with n-hexane at reflux temperature, shall § 177.2800 Textiles and textile fibers. yield total extractives not to exceed Textiles and textile fibers may safely 175 milligrams per square inch during be used as articles or components of ar- the first 7 hours of extraction, nor to ticles intended for use in producing, exceed 4 milligrams per square inch manufacturing, packing, processing, during the succeeding 2 hours of ex- preparing, treating, packaging, trans- traction. porting, or holding food, subject to the (g) In accordance with good manufac- provisions of this section. turing practice finished rubber articles (a) The textiles and textile fibers are intended for repeated use in contact prepared from one or more of the fibers with food shall be thoroughly cleansed identified in paragraph (d) of this sec- prior to their first use in contact with tion and from certain other adjuvant food. substances required in the production (h) The provisions of this section are of the textiles or textile fibers or added not applicable to rubber nursing-bottle to impart desired properties. nipples. (b) The quantity of any adjuvant sub- (i) Acrylonitrile copolymers identi- stance employed in the production of fied in this section shall comply with textiles or textile fibers does not ex- the provisions of § 180.22 of this chap- ceed the amount reasonably required ter. to accomplish the intended physical or [42 FR 14572, Mar. 15, 1977] technical effect or any limitation fur- EDITORIAL NOTE: For FEDERAL REGISTER ci- ther provided. tations affecting § 177.2600, see the List of (c) Any substance employed in the CFR Sections Affected in the Finding Aids production of textiles or textile fibers section of this volume. that is the subject of a regulation in
331
VerDate 06
parts 174, 175, 176, 177, 178 and § 179.45 of (3) Substances generally recognized this chapter conforms with any speci- as safe for use in cotton and cotton fab- fication in such regulation. rics used in dry-food packaging. (d) Substances employed in the pro- (4) Substances that by regulation in duction of or added to textiles and tex- this part may safely be used in the pro- tile fibers may include: duction of or as a component of tex- (1) Substances generally recognized tiles or textile fibers and subject to as safe in food. provisions of such regulation. (2) Substances subject to prior sanc- (5) Substances identified in this para- tion or approval for use in textiles and textile fibers and used in accordance graph (d)(5), subject to such limitations with such sanction or approval. 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. 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 400±3,000). Potassium hydroxide. Propylene glycol. Sodium hydroxide. Sulfuric acid. Formaldehyde ...... For use as preservative only. Glyceryl mono-12-hydroxystearate. 2-(9-Heptadecenyl)-1-[2-(10-octadecenamido)ethyl-2- imidazolinium ethyl sulfate. Hexylene glycol (2-methyl,-2,4-pentanediol). Isobutyl alcohol. Isopropyl alcohol. Kerosene. Methyl ester of sulfated ricebran oil. Mineral oil ...... For use only at a level not to exceed 0.15 percent by weight of finished fibers. Mono- and diisopropylated m- and p-cresols (isothymol 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).
332
VerDate 06
List of substances Limitations
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.
(e) Textile and textile fibers are used poly(vinylidene fluoride) membrane as articles or components of articles with a hydrophilic surface modifier that contact dry food only. consisting of hydroxypropyl acrylate/ (f) The provisions of this section are tetraethylene glycol diacrylate copoly- not applicable to jute fibers used as mer. prescribed by § 178.3620(d)(2) of this (b) Any substance employed in the chapter. production of ultra-filtration mem- branes that is the subject of a regula- [42 FR 14572, Mar. 15, 1977, as amended at 46 FR 37042, July 17, 1981; 49 FR 4372, Feb. 6, tion in parts 174, 175, 176, 177, 178 and 1984; 49 FR 5748, Feb. 15, 1984; 56 FR 42933, § 179.45 of this chapter conforms with Aug. 30, 1991] the specifications of such regulation. (c) Ultra-filtration membranes are § 177.2910 Ultra-filtration membranes. used in the physical separation of dis- Ultra-filtration membranes identi- solved or colloidally suspended varying fied in paragraphs (a)(1), (a)(2), (a)(3), molecular size components of liquids and (a)(4) of this section may be safely during the commercial processing of used in the processing of food, under bulk quantities of food. the following prescribed conditions; (d) Ultra-filtration membranes shall (a)(1) Ultra-filtration membranes be maintained in a sanitary manner in that consist of paper impregnated with accordance with good manufacturing cured phenol-formaldehyde resin, practice so as to prevent potential mi- which is used as a support and is coat- crobial adulteration of the food. ed with a vinyl chloride-acrylonitrile (e) Ultrafiltration membranes identi- copolymer. fied in paragraph (a)(4) may be used to (2) Ultra-filtration membranes that filter aqueous or acidic foods con- consist of a sintered carbon support taining up to 13 percent of alcohol at that is coated with zirconium oxide temperatures not to exceed 21 °C (70 (CAS Reg. No. 1314–23–4) containing up °F). to 12 percent yttrium oxide (CAS Reg. (f) To assure safe use of the ultra-fil- No. 1314–36–9). tration membranes, the label or label- (3) Ultra-filtration membranes that ing shall include adequate directions consist of an aluminum oxide support for a pre-use treatment, consisting of that is coated with zirconium oxide conditioning and washing with a min- (CAS Reg. No. 1314–23–4) containing up imum of 8 gallons of potable water to 5 percent yttrium oxide (CAS Reg. prior to their first use in contact with No. 1314–36–9). food. (4) Ultrafiltration membranes that (g) Acrylonitrile copolymers identi- consist of a microporous fied in this section shall comply with
333
VerDate 06
the provisions of § 180.22 of this chap- 178.3730 Piperonyl butoxide and pyrethrins ter. as components of bags. 178.3740 Plasticizers in polymeric sub- [42 FR 14572, Mar. 15, 1977, as amended at 53 stances. FR 17925, May 19, 1988; 58 FR 48599, Sept. 17, 178.3750 Polyethylene glycol (mean molec- 1993; 60 FR 54426, Oct. 24, 1995] ular weight 200–9,500). 178.3760 Polyethylene glycol (400) PART 178—INDIRECT FOOD ADDI- monolaurate. 178.3770 Polyhydric alcohol esters of TIVES: ADJUVANTS, PRODUCTION oxidatively refined (Gersthofen process) AIDS, AND SANITIZERS montan wax acids. 178.3780 Polyhydric alcohol esters of long Subpart A [Reserved] chain monobasic acids. 178.3790 Polymer modifiers in semirigid and Subpart B—Substances Utilized To Control rigid vinyl chloride plastics. the Growth of Microorganisms 178.3800 Preservatives for wood. 178.3850 Reinforced wax. Sec. 178.3860 Release agents. 178.1005 Hydrogen peroxide solution. 178.3870 Rosins and rosin derivatives. 178.1010 Sanitizing solutions. 178.3900 Sodium pentachlorophenate. 178.3910 Surface lubricants used in the man- Subpart C—Antioxidants and Stabilizers ufacture of metallic articles. 178.2010 Antioxidants and/or stabilizers for 178.3930 Terpene resins. polymers. 178.3940 Tetraethylene glycol di-(2-ethyl- 178.2550 4-Hydroxymethyl-2,6-di-tert-butyl- hexoate). phenol. 178.3950 Tetrahydrofuran. 178.2650 Organotin stabilizers in vinyl chlo- AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. ride plastics. SOURCE: 42 FR 14609, Mar. 15, 1977, unless Subpart D—Certain Adjuvants and otherwise noted. Production Aids EDITORIAL NOTE: Nomenclature changes to part 178 appear at 61 FR 14482, Apr. 2, 1996. 178.3010 Adjuvant substances used in the manufacture of foamed plastics. 178.3120 Animal glue. Subpart A [Reserved] 178.3125 Anticorrosive agents. 178.3130 Antistatic and/or antifogging Subpart B—Substances Utilized To agents in food-packaging materials. 178.3280 Castor oil, hydrogenated. Control the Growth of Micro- 178.3290 Chromic chloride complexes. organisms 178.3295 Clarifying agents for polymers. 178.3297 Colorants for polymers. § 178.1005 Hydrogen peroxide solution. 178.3300 Corrosion inhibitors used for steel Hydrogen peroxide solution identi- or tinplate. 178.3400 Emulsifiers and/or surface-active fied in this section may be safely used agents. to sterilize polymeric food-contact sur- 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- more than 35 percent hydrogen per- carbons, synthetic. 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
334
VerDate 06
applicable regulations in parts 174 Substances Limitations through 179 of this chapter. Vinylidene chloride/ Complying with § 177.1990 of this (c) Specifications. Hydrogen peroxide methyl acrylate co- chapter. solution shall meet the specifications polymers. of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), pp. 146–147, which is incorporated (2) The packaging materials identi- by reference (copies may be obtained fied in paragraph (e)(1) of this section from the National Academy Press, 2101 may be used for packaging all commer- Constitution Ave. NW., Washington, cially sterile foods except that the DC 20418, or may be examined at the olefin polymers may be used in articles Office of the Federal Register, 800 for packaging foods only of the types North Capitol Street, NW., suite 700, identified in § 176.170(c) of this chapter, Washington, DC 20408), and the United table 1, under Categories I, II, III, IV– States Pharmacopeia XX (1980), except B, V, and VI. that hydrogen peroxide may exceed the (3) Processed foods packaged in the concentration specified therein. materials identified in paragraph (e)(1) (d) Limitations. No use of hydrogen of this section shall conform with parts peroxide solution in the sterilization of 108, 110, 113, and 114 of this chapter as food packaging material shall be con- applicable. sidered to be in compliance if more than 0.5 part per million of hydrogen [46 FR 2342, Jan. 9, 1981, as amended at 49 FR peroxide can be determined in distilled 10111, Mar. 19, 1984; 49 FR 32345, Aug. 14, 1984; water packaged under production con- 49 FR 37747, Sept. 26, 1984; 51 FR 45881, Dec. ditions (assay to be performed imme- 23, 1986; 52 FR 26146, July 13, 1987; 53 FR 47186, diately after packaging). Nov. 22, 1988; 54 FR 5604, Feb. 6, 1989; 54 FR (e) Conditions of use. (1) Hydrogen per- 13167, Mar. 31, 1989; 54 FR 6365 Feb. 9, 1989; 55 FR 47055, Nov. 9, 1990; 57 FR 32423, July 22, oxide solution identified in and com- 1992] plying with the specifications in this section may be used by itself or in § 178.1010 Sanitizing solutions. combination with other processes to treat food-contact surfaces to attain Sanitizing solutions may be safely commercial sterility at least equiva- used on food-processing equipment and lent to that attainable by thermal utensils, and on other food-contact ar- processing for metal containers as pro- ticles as specified in this section, with- vided for in part 113 of this chapter. in the following prescribed conditions: Food-contact surfaces include the fol- (a) Such sanitizing solutions are lowing: used, followed by adequate draining, before contact with food. Substances Limitations (b) The solutions consist of one of the Ethylene-acrylic acid Complying with § 177.1310 of this following, to which may be added com- copolymers. chapter. ponents generally recognized as safe Ethylene-carbon mon- Complying with § 177.1312 of this and components which are permitted oxide copolymers. chapter. Ethylene-methyl acry- Complying with § 177.1340 of this by prior sanction or approval. late copolymer resins. chapter. (1) An aqueous solution containing Ethylene-vinyl acetate Complying with § 177.1350 of this potassium, sodium, or calcium hypo- copolymers. chapter. Ionomeric resins ...... Complying with § 177.1330 of this chlorite, with or without the bromides chapter. of potassium, sodium, or calcium. Isobutylene polymers ... Complying with § 177.1420 (a)(1) (2) An aqueous solution containing and (a)(2) of this chapter. Olefin polymers ...... Complying with § 177.1520 of this dichloroisocyanuric acid, chapter. trichloroisocyanuric acid, or the so- Polycarbonate resins ... Complying with § 177.1580 of this dium or potassium salts of these acids, chapter. Polyethylene- Complying with § 177.1630 of this with or without the bromides of potas- terephthalate poly- chapter (excluding polymers de- sium, sodium, or calcium. mers. scribed in § 177.1630(c)) of this (3) An aqueous solution containing chapter. Poly-l-butene resins Complying with § 177.1570 of this potassium iodide, sodium p- and butene/ethylene chapter. toluenesulfonchloroamide, and sodium copolymers. lauryl sulfate. Polystryrene and rub- Complying with § 177.1640 of this ber-modified poly- chapter. (4) An aqueous solution containing styrene polymers. iodine, butoxy monoether of mixed
335
VerDate 06
(ethylene-propylene) polyalkylene gly- of groups with 8 and 10 carbon atoms. col having a cloudpoint of 90°–100 °C in Additionally, the aqueous solution may 0.5 percent aqueous solution and an av- contain either ethyl alcohol or iso- erage molecular weight of 3,300, and propyl alcohol as an optional ingre- ethylene glycol monobutyl ether. Addi- dient. tionally, the aqueous solution may (10) An aqueous solution containing contain diethylene glycol monoethyl trichloromelamine and either sodium ether as an optional ingredient. lauryl sulfate or dodecyl- (5) An aqueous solution containing benzenesulfonic acid. In addition to use elemental iodine, hydriodic acid, a-(p- on food-processing equipment and nonylphenyl)-omega-hydroxypoly-(oxy- utensils and other food-contact arti- ethylene) (complying with the identity cles, this solution may be used on bev- prescribed in § 178.3400(c) and having a erage containers except milk con- maximum average molecular weight of tainers or equipment. 748) and/or polyoxyethylene- (11) An aqueous solution containing polyoxypropylene block polymers (hav- equal amounts of n-alkyl (C12-C18) ben- ing a minimum average molecular zyl dimethyl ammonium chloride and weight of 1,900). Additionally, the aque- n-alkyl (C12-C18) dimethyl ethylbenzyl ous solution may contain isopropyl al- ammonium chloride (having an average cohol as an optional ingredient. molecular weight of 384). In addition to (6) An aqueous solution containing use on food-processing equipment and elemental iodine, sodium iodide, so- utensils, this solution may be used on dium dioctylsulfosuccinate, and food-contact surfaces in public eating polyoxyethylene-polyoxypropylene places. block polymers (having a minimum av- (12) An aqueous solution containing erage molecular weight of 1,900). the sodium salt of sulfonated oleic (7) An aqueous solution containing acid, polyoxyethylene- dodecylbenzenesulfonic acid and either polyoxypropylene block polymers (hav- isopropyl alcohol or polyoxyethylene- ing an average molecular weight of polyoxypropylene block polymers (hav- 2,000 and 27 to 31 moles of ing a minimum average molecular weight of 2,800). In addition to use on polyoxypropylene). In addition to use food-processing equipment and uten- on food-processing equipment and sils, this solution may be used on glass utensils, this solution may be used on bottles and other glass containers in- glass bottles and other glass containers tended for holding milk. intended for holding milk. All equip- (8) An aqueous solution containing ment, utensils, glass bottles, and other elemental iodine, butoxy monoether of glass containers treated with this sani- mixed (ethylene-propylene) tizing solution shall have a drainage polyalkylene glycol having a minimum period of 15 minutes prior to use in average molecular weight of 2,400 and contact with food. 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.
336
VerDate 06
(16) An aqueous solution containing (21) An aqueous solution containing equal amounts of n-alkyl (C12-C18) ben- sodium dodecylbenzenesulfonate. In ad- zyl dimethyl ammonium chloride and dition to use on food-processing equip- n-alkyl (C12-C14) dimethyl ethylbenzyl ment and utensils, this solution may ammonium chloride (having average be used on glass bottles and other glass molecular weights of 377 to 384), with containers intended for holding milk. the optional adjuvant substances (22) An aqueous solution containing tetrasodium ethylenediaminetetra- (1) di-n-alkyl(C8-C10) acetate and/or alpha-(p-nonylphenol)- dimethylammonium chloride com- omega-hydroxy poly (oxyethylene) hav- pounds having average molecular ing an average poly- (oxyethylene) con- weights of 332–361, (2) n-alkyl (C12-C18) tent of 11 moles. Alpha-hydro-omega- benzyldimethylammonium chloride hydroxypoly-(oxyethylene) compounds having average molecular poly(oxypropoylene) (15 to 18 mole weights of 351–380 and consisting prin- minimum) poly (oxyethylene) block co- cipally of alkyl groups with 12 to 16 polymer, having a minimum molecular carbon atoms with or without not over weight of 1,900 (CAS Registry No. 9003– 1 percent each of groups with 8 and 10 11–6) may be used in lieu of alpha- (p- carbon atoms, and (3) ethyl alcohol. nonylphenol)-omega-hydroxy- The ratio of compound (1) to compound poly(oxyethylene) having an average (2) is 60 to 40. poly(oxyethylene) content of 11 moles. (23) An aqueous solution containing In addition to use on food-processing n-alkyl (C12-C16) benzyl- equipment and utensils, this solution dimethylammonium chloride and may be used on food-contact surfaces didecyldimethylammonium chloride. in public eating places. (24) An aqueous solution containing (17) An aqueous solution containing elemental iodine (CAS Reg. No. 7553–56– di-n-alkyl(C -C )dimethyl ammonium 8 10 2), alpha-[p-(1,1,3,3-tetramethylbutyl)- chlorides having average molecular phenyl]-omega-hydroxypoly-(oxy- weights of 332–361 and either ethyl al- ethylene) produced with one mole of cohol or isopropyl alcohol. In addition the phenol and 4 to 14 moles ethylene to use on food-processing equipment and utensils, this solution may be used oxide, and alpha-alkyl(C12-C15)-omega- on food-contact surfaces in public eat- hydroxy[poly(oxyethylene) ing places. poly(oxypropylene)] (having an average (18) An aqueous solution containing molecular weight of 965). (25) An aqueous solution containing n-alkyl(C12-C18) benzyldimethylammo- nium chloride, sodium metaborate, elemental iodine (CAS Reg. No. 7553–56– alpha-terpineol and alpha[p-(1,1,3,3- 2), potassium iodide (CAS Reg. No. tetramethylbutyl)phenyl] -omega-hy- 7681–11–0), and isopropanol (CAS Reg. droxy-poly (oxyethylene) produced No. 67–63–0). In addition to use on food with one mole of the phenol and 4 to 14 processing equipment and utensils, this moles ethylene oxide. solution may be used on beverage con- (19) An aqueous solution containing tainers, including milk containers and sodium dichloroisocyanurate and equipment and on food-contact sur- tetrasodium ethylenediaminetetra- faces in public eating places. acetate. In addition to use on food- (26) [Reserved] processing equipment and utensils, this (27) An aqueous solution containing solution may be used on food-contact decanoic acid (CAS Reg. No. 334–48–5), surfaces in public eating places. octanoic acid (CAS Reg. No. 124–07–2), (20) An aqueous solution containing and sodium 1-octanesulfonate (CAS ortho-phenylphenol, ortho-benzyl-para- Reg. No. 5324–84–5). Additionally, the chlorophenol, para- aqueous solution may contain iso- tertiaryamylphenol, sodium -alpha- propyl alcohol (CAS Reg. No. 67–63–0) alkyl(C12-C15)-omega-hydroxypoly (oxy- as an optional ingredient. ethylene) sulfate with the (28) An aqueous solution containing poly(oxyethylene) content averaging sulfonated 9-octadecenoic acid (CAS one mole, potassium salts of coconut Reg. No. 68988–76–1) and sodium oil fatty acids, and isopropyl alcohol or xylenesulfonate (CAS Reg. No. 1300–72– hexylene glycol. 7).
337
VerDate 06
(29) An aqueous solution containing tetraacetate. Additionally, the aqueous dodecyldiphenyloxidedisulfonic acid solution contains either alpha-(p- (CAS Reg. No. 30260–73–2), sulfonated nonylphenyl)-omega-hydroxypoly-(oxy- tall oil fatty acid (CAS Reg. No. 68309– ethylene) or alpha-alkyl(C11-C15)-omega- 27–3), and neo-decanoic acid (CAS Reg. hydroxypoly-(oxyethylene), each pro- No. 26896–20–8). In addition to use on duced with 9 to 13 moles of ethylene food-processing equipment and uten- oxide. The ratio of compound (i) to sils, this solution may be used on glass compound (ii) is 3 to 2. bottles and other glass containers in- (34) An aqueous solution of an equi- tended for holding milk. librium mixture of oxychloro species (30) An aqueous solution containing (predominantly chlorite, chlorate, and hydrogen peroxide (CAS Reg. No. 7722– chlorine dioxide) generated either (i) 84–1), peracetic acid (CAS Reg. No. 79– by directly metering a concentrated 21–0), acetic acid (CAS Reg. No. 64–19– chlorine dioxide solution, prepared just 7), and 1-hydroxyethylidene-1,1- prior to use, into potable water to pro- diphosphonic acid (CAS Reg. No. 2809– vide the concentration of available 21–4). chlorine dioxide stated in paragraph (31) An aqueous solution containing (c)(29) of this section, or (ii) by acidifi- elemental iodine, alpha-alkyl(C10-C14)- cation of an aqueous alkaline solution omega-hydroxypoly(oxyethylene)poly- of oxychloro species (predominantly (oxypropylene) of average molecular chlorite and chlorate) followed by dilu- weight between 768 and 837, and alpha- tion with potable water to provide the alkyl(C12-C18)-omega- concentration of available chlorine di- hydroxypoly(oxyethylene) oxide described in paragraph (c)(29) of poly(oxypropylene) of average molec- this section. ular weight between 950 and 1,120. In (35) An aqueous solution containing addition to use on food-processing decanoic acid (CAS Reg. No. 334–48–5), equipment and utensils, this solution octanoic acid (CAS Reg. No. 124–07–2), may be used on food-contact surfaces lactic acid (CAS Reg. No. 050–21–5), in public eating places. phosphoric acid (CAS Reg. No. 7664–38– (32) An aqueous solution containing 2) and a mixture of the sodium salt of (i) di-n-alkyl(C8–C10)dimethyl- ammo- naphthalenesulfonic acid (CAS Reg. nium chloride compounds having aver- No. 1321–69–3); the methyl, dimethyl, age molecular weights of 332 to 361, (ii) and trimethyl dervatives of the sodium n-alkyl(C12–C18)benzyldimethyl- ammo- salt of naphthalenesulfonic acid; and a nium chloride compounds having aver- mixture of the sodium salt of age molecular weights of 351 to 380 and naphthalenesulfonic acid, and the consisting principally of alkyl groups methyl, dimethyl, and trimethyl de- with 12 to 16 carbon atoms with no rivatives of the sodium salt of more than 1 percent of groups with 8 naphthalenesulfonic acid alkylated at 3 and 10, (iii) ethyl alcohol, and (iv) percent by weight with C6–C9 linear alpha-(p-nonylphenyl)-omega- olefins, as components of a sanitizing hydroxypoly(oxyethylene) produced by solution to be used on food-processing the condensation of 1 mole of p- equipment and utensils. The methyl nonylphenol with 9 to 12 moles of and dimethyl substituted derivatives ethylene oxide. The ratio of compound (described within this paragraph (i) to compound (ii) is 3 to 2. (b)(35)) constitute no less than 70 per- (33) An aqueous solution containing cent by weight of the mixture of (i) di-n-alkyl-(C8-C10)- naphthalenesulfonates. dimethylammonium chloride com- (36) The sanitizing solution contains pounds having average molecular decanoic acid (CAS Reg. No. 334–48–5); weights of 332 to 361; (ii) n-alkyl(C12- octanoic acid (CAS Reg. No. 124–07–2); C18) -benzyldimethylammonium chlo- lactic acid (CAS Reg. No. 050–21–5); ride compounds having molecular phosphoric acid (CAS Reg. No. 7664–38– weights of 351 to 380 and consisting 2); a mixture of 1-octanesulfonic acid principally of alkyl groups with 12 to 16 (CAS Reg. No. 3944–72–7), and 1- carbon atoms with no more than 1 per- octanesulfonic-2-sulfinic acid (CAS cent of the groups with 8 to 10; and (iii) Reg. No. 113652–56–5) or 1,2- tetrasodium ethylenediamine octanedisulfonic acid (CAS Reg. No.
338
VerDate 06
1934210); the condensate of four moles (CAS Reg. No. 7664–38–2); isopropyl al- of cohol (CAS Reg. No. 67–63–0); and cal- poly(oxyethylene)poly(oxypropylene) cium chloride (CAS Reg. No. 10043–52– block copolymers with one mole of 4). In addition to use on food-proc- ethylenediamine (CAS Reg. No. 11111– essing equipment and utensils, this so- 34–5); and the optional ingredient lution may be used on dairy-processing FD&C Yellow No. 5 (CAS Reg. No. equipment. 001934210). In addition to use on food- (41) An aqueous solution containing processing equipment and utensils, this n-alkyl(C12- solution may be used on dairy-proc- C16)benzyldimethylammonium chlo- essing equipment. ride, having average molecular weights (37) The sanitizing solution contains ranging from 351 to 380 wherein the sodium hypochlorite (CAS Reg. No. alkyl groups contain principally 12 to 7681–52–9), trisodium phosphate (CAS 16 carbons and not more than 1 percent Reg. No. 7601–54–9), sodium lauryl sul- each of the groups with 8 and 10 carbon fate (CAS Reg. No. 151–21–3), and potas- atoms; ammonium chloride (CAS Reg. sium permanganate (CAS Reg. No. No. 12125–02–9); calcium stearate (CAS 7722–64–7). Magnesium oxide (CAS Reg. Reg. No. 1592–23–0); sodium bicarbonate No. 1309–48–4) and potassium bromide (CAS Reg. No. 144–55–8); starch or (CAS Reg. No. 7758–02–3) may be added dextrin, or both starch and dextrin as optional ingredients to this sani- (CAS Reg. No. 9004–53–9); and the op- tizing solution. In addition to use on tional ingredient methylene blue (CAS food-processing equipment and uten- Reg. No. 61–73–4). In addition to use on sils, this solution may be used on food- food-processing equipment and uten- contact surfaces in public eating sils, this solution may be used on food- places. contact surfaces in public eating (38) An aqueous solution containing places. hydrogen peroxide (CAS Reg. No. 7722– (42) An aqueous solution containing 84–1); peroxyacetic acid (CAS Reg. No. decanoic acid (CAS Reg. No. 334–48–5), 79–21–0); acetic acid (CAS Reg. No. 64– nonanoic acid (CAS Reg. No. 112–05–0), 19–7); sulfuric acid (CAS Reg. No. 7664– phosphoric acid (CAS Reg. No. 7664–38– 93–9); and 2,6-pyridinedicarboxylic acid 2), propionic acid (CAS Reg No. 79–09– (CAS Reg. No. 499–83–2). In addition to 04), and sodium 1-octanesulfonate (CAS use on food-processing equipment and Reg. No. 5324–84–5). Sulfuric acid (CAS utensils, this solution may be used on Reg. No. 7664–93–9) may be added as an dairy-processing equipment. optional ingredient. In addition to use (39) An aqueous solution containing on food-processing equipment and phosphoric acid (CAS Reg. No. 7664–38– utensils, this solution may be used on 2); octenyl succinic acid (CAS Reg. No. dairy-processing equipment. 28805–58–5); N,N-dimethyloctanamine (43) An aqueous solution of iodine (CAS Reg. No. 7378–99–6); and a mixture and hypochlorous acid generated by of n-carboxylic acids (C6–C12, consisting the dilution of an aqueous acidic (21.5 of not less than 56 percent octanoic percent nitric acid) solution of iodine acid and not less than 40 percent deca- monochloride. In addition to use on noic acid). This solution may be used food-processing equipment and uten- on food-processing equipment and sils, this solution may be used on utensils, including dairy-processing dairy-processing equipment. equipment. (44) An aqueous solution of citric (40) An aqueous solution prepared by acid, disodium ethylenediaminetetra- combining elemental iodine (CAS Reg. acetate, sodium lauryl sulfate, and No. 7553–56–2); hydriodic acid (CAS Reg. monosodium phosphate. In addition to No. 10034–85–2); sodium N-cyclohexyl-N- use on food-processing equipment and palmitoyl taurate (CAS Reg. No. 132– utensils, this solution may be used on 43–4); chloroacetic acid, sodium salt re- dairy-processing equipment. action products with 4,5-dihydro-2- (45) An aqueous solution of hydrogen undecyl-1H-imidazole-1-ethanol and so- peroxide, acetic acid, peroxyacetic dium hydroxide (CAS Reg. No. 68608–66– acid, octanoic acid, peroxyoctanoic 2); dodecylbenzene sulfonic acid (CAS acid, sodium 1-octanesulfonate, and 1- Reg. No. 27176–87–0); phosphoric acid hydroxyethylidene-1,1-diphosphonic
339
VerDate 06
acid. In addition to use on food-proc- (6) Solutions identified in paragraph essing equipment and utensils, this so- (b)(9) of this section shall provide when lution may be used on food-contact ready to use no more than 200 parts per surfaces in public eating places, sub- million of the active quaternary com- ject to the limitations in paragraph pound. (c)(39) of this section. (7) Solutions identified in paragraph (46) An aqueous solution of chlorine (b)(10) of this section shall provide not dioxide and related oxychloro species more than sufficient generated by acidification of an aque- trichloromelamine to produce 200 parts ous solution of sodium chlorite with a per million of available chlorine and ei- solution of sodium gluconate, citric ther sodium lauryl sulfate at a level acid, phosphoric acid, and sodium not in excess of the minimum required mono- and to produce its intended functional ef- didodecylphenoxybenzenedisulfonate. fect or not more than 400 parts per mil- In addition to use on food-processing lion of dodecylbenzenesulfonic acid. equipment and utensils, this solution (8) Solutions identified in paragraph may be used on dairy-processing equip- (b)(11) of this section shall provide, ment. when ready to use, not more than 200 (c) The solutions identified in para- parts per million of active quaternary graph (b) of this section will not exceed compound. the following concentrations: (9) The solution identified in para- (1) Solutions identified in paragraph graph (b)(12) of this section shall pro- (b)(1) of this section will provide not vide not more than 200 parts per mil- more than 200 parts per million of lion of sulfonated oleic acid, sodium available halogen determined as avail- salt. able chlorine. (10) Solutions identified in paragraph (2) Solutions identified in paragraph (b)(15) of this section will provide not (b)(2) of this section will provide not more than 200 parts per million of more than 100 parts per million of available chlorine and not more than 30 available halogen determined as avail- ppm lithium. able chlorine. (11) Solutions identified in paragraph (3) Solution identified in paragraph (b)(16) of this section shall provide not (b)(3) of this section will provide not more than 200 parts per million of ac- more than 25 parts per million of ti- tive quaternary compound. tratable iodine. The solutions will con- (12) Solutions identified in paragraph tain the components potassium iodide, (b)(17) of this section shall provide, sodium p-toluenesulfonchloramide and when ready to use, a level of 150 parts sodium lauryl sulfate at a level not in per million of the active quaternary excess of the minimum required to compound. produce their intended functional ef- (13) Solutions identified in paragraph fect. (b)(18) of this section shall provide not (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
340
VerDate 06
parts per million para- oxide, not less than 100 parts per mil- tertiaryamylphenol. lion and not more than 200 parts per (16) Solution identified in paragraph million peracetic acid, not less than 150 (b)(21) of this section shall provide not parts per million and not more than 300 more than 430 parts per million and not parts per million acetic acid, and not less than 25 parts per million of sodium less than 15 parts per million and not dodecylbenzenesulfonate. more than 30 parts per million 1- (17) Solutions identified in paragraph hydroxyethylidene-1,1-diphosphonic (b)(22) of this section shall provide, acid. when ready to use, at least 150 parts (26) The solution identified in para- per million and not more than 400 parts graph (b)(31) of this section shall pro- per million of active quaternary com- vide, when ready to use, at least 12.5 pound. parts per million and not more than 25 (18) Solutions identified in paragraph parts per million of titratable iodine. (b)(23) of this section shall provide at The adjuvants used with the iodine will least 150 parts per million and not not be in excess of the minimum more than 200 parts per million of the amounts required to accomplish the in- active quaternary compound. tended technical effect. (19) Solutions identified in para- (27) Solutions identified in paragraph graphs (b)(24), (b)(25), and (b)(43) of this (b)(32) of this section shall provide, section shall provide at least 12.5 parts when ready to use, at least 150 parts per million and not more than 25 parts per million and no more than 400 parts per million of titratable iodine. The ad- per million of active quarternary com- juvants used with the iodine shall not pounds in solutions containing no more be in excess of the minimum amounts than 600 parts per million water hard- required to accomplish the intended ness. The adjuvants used with the technical effect. quarternary compounds will not exceed (20)–(21) [Reserved] the amounts required to accomplish (22) Solutions identified in paragraph the intended technical effect. (b)(27) of this section shall provide, (28) Solutions identified in paragraph when ready to use, at least 109 parts (b)(33) of this section shall provide, per million and not more than 218 parts when ready to use, at least 150 parts per million of total active fatty acids per million and not more than 400 parts and at least 156 parts per million and per million of active quaternary com- not more than 312 parts per million of pounds. The adjuvants used with the the sodium 1-octanesulfonate. quaternary compounds shall not exceed (23) Solutions identified in paragraph the amounts required to accomplish (b)(28) of this section shall provide, the intended technical effect. when ready to use, at least 156 parts Tetrasodium ethylenediamine per million and not more than 312 parts tetraacetate shall be added at a min- per million of sulfonated 9- imum level of 60 parts per million. Use 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
341
VerDate 06
the Federal Register, 800 North Capitol than 0.7 part per million on potassium Street, NW., suite 700, Washington, DC permanganate. 20408. (ii) The solution identified in para- (30) Solutions identified in paragraph graph (b)(37) of this section with potas- (b)(35) of this section shall provide, sium bromide shall provide, when when ready for use, at least 117 parts ready to use, at least 25 parts per mil- per million and not more than 234 parts lion and not more than 200 parts per per million of total fatty acids and at million of available halogen deter- least 166 parts per million and not mined as available chlorine; at least 15 more than 332 parts per million of a parts per million and not more than 46 mixture of naphthalenesulfonates. The parts per million of potassium bro- adjuvants phosphoric acid and lactic mide; at least 690 parts per million and acid, used with decanoic acid, octanoic not more than 2,072 parts per million of acid, and sodium naphthalenesulfonate trisodium phosphate; at least 0.3 part and its alkylated derivatives, will not per million and not more than 1 part be in excess of the minimum amounts per million of sodium lauryl sulfate; required to accomplish the intended and at least 0.1 part per million and technical effects. not more than 0.3 part per million of potassium permanganate. (31) Solutions identified in paragraph (iii) Magnesium oxide when used in (b)(36) of this section shall provide, paragraph (c)(32) (i) or (ii) of this sec- when ready for use, at least 29 parts per tion shall not be used in excess of the million and not more than 58 parts per minimum amount required to accom- million decanoic acid; at least 88 parts plish its intended technical effect. per million and not more than 176 parts (33) Solutions identified in paragraph per million of octanoic acid; at least 69 (b)(38) of this section shall provide parts per million and not more than 138 when ready for use not less than 300 parts per million of lactic acid; at least parts per million and not more than 465 256 parts per million and not more than parts per million of hydrogen peroxide; 512 parts per million of phosphoric not less than 200 parts per million and acid; at least 86 parts per million and not more than 315 parts per million of not more than 172 parts per million of peroxyacetic acid; not less than 200 1-octanesulfonic acid; at least 51 parts parts per million and not more than 340 per million and not more than 102 parts parts per million of acetic acid; not per million of 1-octanesulfonic-2- less than 10 parts per million and not sulfinic acid or 1,2-octanedisulfonic more than 20 parts per million of sul- acid; and at least 10 parts per million furic acid; and not less than 0.75 parts and not more than 20 parts per million per million and not more than 1.2 parts of the condensate of four moles of per million of 2,6-pyridinedicarboxylic poly(oxyethylene)poly(oxypropylene) acid. block copolymers with one mole of (34) Solutions identified in paragraph ethylenediamine. The colorant adju- (b)(39) of this section shall provide vant FD&C Yellow No. 5 shall not be when ready for use not less than 460 used in excess of the minimum amount parts per million and not more than 625 required to accomplish the intended parts per million of phosphoric acid, technical effect. and all components shall be present in (32)(i) The solution identified in para- the following proportions: 1 part phos- graph (b)(37) of this section without po- phoric acid to 0.25 octenyl succinic acid tassium bromide shall provide, when to 0.18 part N,N-dimethyloctanamine to ready to use, at least 100 parts per mil- 0.062 part of a mixture of n-carboxylic lion and not more than 200 parts per acids (C6–C12, consisting of not less than million of available halogen deter- 56 percent octanoic acid and not less mined as available chlorine; at least than 40 percent decanoic acid). 2,958 parts per million and not more (35) Solutions identified in paragraph than 5,916 parts per million of tri- (b)(40) of this section shall provide sodium phosphate; at least 1 part per when ready for use not less than 12.5 million and not more than 3 parts per parts per million and not more than million of sodium lauryl sulfate; and at 25.0 parts per million of titratable io- least 0.3 part per million and not more dine; and not less than 2.7 parts per
342
VerDate 06
million and not more than 5.5 parts per 32,900 parts per million of citric acid; at million of dodecylbenzene sulfonic least 700 parts per million and not acid. All components shall be present more than 1,400 parts per million of di- in the following proportions: 1.0 part sodium ethylenediaminetetraacetate; dodecylbenzene sulfonic acid to 43 at least 175 parts per million and not parts sodium N-cyclohexyl-N-palmitoyl more than 350 parts per million of so- taurate to 7.7 parts chloroacetic acid, dium lauryl sulfate; and at least 175 sodium salt, reaction products with 4,5- parts per million and not more than 350 dihydro-2-undecyl-1H-imidazole-1-eth- parts per million of monosodium phos- anol and sodium hydroxide to 114 parts phate. phosphoric acid to 57 parts isopropyl (39)(i) The solution identified in para- alcohol to 3.0 parts calcium chloride. graph (b)(45) of this section, when used (36) Solutions identified in paragraph on food processing equipment and uten- (b)(41) of this section shall provide, sils, including dairy and beverage-proc- when ready for use, not less than 150 essing equipment but excluding food- parts per million and not more than 200 contact surfaces in public eating places parts per million of n-alkyl(C12- and dairy and beverage containers, C16)benzyldimethylammonium chlo- shall provide when ready for use at ride; and not more than 0.4 part per least 72 parts per million and not more million of the colorant methylene blue. than 216 parts per million of hydrogen Components shall be present in the peroxide; at least 46 parts per million product used to prepare the solution in and not more than 138 parts per million the following proportions: 1 part n- of peroxyacetic acid; at least 40 parts alkyl(C12- per million and not more than 122 parts C16)benzyldimethylammonium chloride per million of octanoic acid (including to 0.24 part ammonium chloride to 0.08 peroxyoctanoic acid); at least 281 parts part calcium stearate to 0.60 part so- per million and not more than 686 parts dium bicarbonate to 0.08 part starch or per million of acetic acid; at least 7 dextrin, or a combination of starch and parts per million and not more than 34 dextrin. parts per million of 1- (37)(i) The solution identified in para- hydroxyethylidene-1,1-diphosphonic graph (b)(42) of this section not con- acid; and at least 36 parts per million taining sulfuric acid shall provide when and not more than 109 parts per million ready for use not less than 45 parts per of sodium 1-octanesulfonate. million and not more than 90 parts per (ii) The solution identified in para- million of decanoic acid; and all com- graph (b)(45) of this section, when used ponents shall be present in the fol- on food-contact equipment and utensils lowing proportions (weight/weight (w/ in warewashing machines, including w)): 1 part decanoic acid to 1 part nona- warewashing machines in public eating noic acid to 9.5 parts phosphoric acid to places, at temperatures no less than 120 3.3 parts propionic acid to 3.3 parts so- °F (49 °C) shall provide when ready for dium 1-octanesulfonate. use at least 30 parts per million and (ii) The solution identified in para- not more than 91 parts per million of graph (b)(42) of this section containing hydrogen peroxide; at least 19 parts per sulfuric acid shall provide when ready million and not more than 58 parts per for use not less than 45 parts per mil- million of peroxyacetic acid; at least 17 lion and not more than 90 parts per parts per million and not more than 52 million of decanoic acid; and all com- parts per million of octanoic acid (in- ponents shall be present in the fol- cluding peroxyoctanoic acid); at least lowing proportions (w/w): 1 part deca- 119 parts per million and not more than noic acid to 1 part nonanoic acid to 2.8 290 parts per million of acetic acid; at parts phosphoric acid to 3.3 parts propi- least 3 parts per million and not more onic acid to 3.3 parts sodium 1- than 14 parts per million of 1- octanesulfonate to 3.2 parts sulfuric hydroxyethylidene-1,1-diphosphonic acid. acid; and at least 15 parts per million (38) The solution identified in para- and not more than 46 parts per million graph (b)(44) of this section shall 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
343
VerDate 06
on dairy or beverage containers, shall DC; at least 380 parts per million and provide when ready for use at least 36 not more than 760 parts per million of parts per million and not more than 108 sodium gluconate; and at least 960 parts per million of hydrogen peroxide; parts per million and not more than at least 23 parts per million and not 1,920 parts per million of sodium mono- more than 69 parts per million of per- and oxyacetic acid; at least 20 parts per didodecylphenoxybenzenedisulfonate. million and not more than 61 parts per Other components listed under para- million of octanoic acid (including graph (b)(46) of this section shall be peroxyoctanoic acid); at least 140 parts used in the minimum amount nec- per million and not more than 343 parts essary to produce the intended effect. per million of acetic acid; at least 3 (d) Sanitizing agents for use in ac- parts per million and not more than 17 cordance with this section will bear la- parts per million of 1- beling meeting the requirements of the hydroxyethylidene-1,1-diphosphonic Federal Insecticide, Fungicide, and acid; and at least 18 parts per million Rodenticide Act. and not more than 55 parts per million of sodium 1-octanesulfonate. [42 FR 14609, Mar. 16, 1977] (40) The solution identified in para- EDITORIAL NOTE: For FEDERAL REGISTER ci- graph (b)(46) of this section shall pro- tations affecting § 178.1010, see the List of vide, when ready for use, at least 100 CFR Sections Affected in the Finding Aids parts per million and not more than 200 section of this volume. parts per million of chlorine dioxide as determined by the method developed Subpart C—Antioxidants and by Bio-cide International, Inc., enti- Stabilizers tled, ‘‘Iodometric Method for the De- termination of Available Chlorine Di- § 178.2010 Antioxidants and/or stabi- lizers for polymers. oxide (50–250 ppm Available ClO2),’’ dated June 11, 1987, which is incor- The substances listed in paragraph porated by reference in accordance (b) of this section may be safely used as with 5 U.S.C. 552(a) and 1 CFR part 51. antioxidants and/or stabilizers in poly- Copies of this method are available mers used in the manufacture of arti- from the Division of Petition Control, cles or components of articles intended Center for Food Safety and Applied Nu- for use in producing, manufacturing, trition (HFS–215), Food and Drug Ad- packing, processing, preparing, treat- ministration, 200 C St. SW., Wash- ing, packaging, transporting, or hold- ington, DC 20204, and may be examined ing food, subject to the provisions of at the Center for Food Safety and Ap- this section: plied Nutrition’s Library, Food and (a) The quantity used shall not ex- Drug Administration, 200 C St. SW., ceed the amount reasonably required rm. 3321, Washington, DC, or at the Of- to accomplish the intended technical fice of the Federal Register, 800 North effect. Capitol St. NW., suite 700, Washington, (b) List of substances:
Substances Limitations
N-n-Alkyl-N′-(carboxymethyl)-N,N′- For use only: trimethylenediglycine; the alkyl group is even 1. As component of nonfood articles complying with §§ 175.105 and numbered in the range C14–C18 and the nitrogen 177.2600 of this chapter. content is in the range 5.4±5.6 weight percent. 2. At levels not to exceed 1.35 percent by weight of natural rubber, 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: acid-catalyzed condensation re- For use only at levels not to exceed 2 percent by weight of adhesives com- action products of 4-nonylphenol, formaldehyde, plying with § 175.105 of this chapter, of pressure-sensitive adhesives and 1-dodecanethiol (CAS Reg. No. 164907± complying with § 175.125 of this chapter, and of rubber articles complying 73±7). with § 177.2600 of this chapter.
344
VerDate 06
Substances Limitations
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. 57569±40±1). 2-(2H-Benzotriazol-2-yl)-4,6-bis(1-methyl-1- For use only: phenylethyl)phenol (CAS Reg. No. 70321±86±7). 1. At levels not to exceed 0.5 percent by weight of polyethylene phthalate polymers complying with § 177.1630 of this chapter. 2. At levels not to exceed 3.0 percent by weight of polycarbonate resins complying with § 177.1580 of this chapter. 2-(2H-Benzotriazol-2-yl)-4-(1, 1, 3, 3- For use only at levels not to exceed 0.5 percent by weight of polycarbonate tetramethylbutyl) phenol (CAS Reg. No. 3147± resins complying with § 177.1580 of this chapter: Provided, That the fin- 75±9). ished resins contact food only under conditions of use E, F, and G de- scribed in table 2 of § 176.170(c) of this chapter. β, 3(or 4)-Bis(octadecylthio)cyclohexylethane (CAS For use only: Reg. No. 37625±75±5); CAS synonym: 1-[(beta- 1. At levels not to exceed 0.3 percent by weight of all polymers for use in (octadecylthio)ethyl]-3(or 4)- contact with foods of Types I, II, IV-B, VI, VII-B, and VIII under conditions (octadecylthio)cyclohexane. of use B through H as described in tables 1 and 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.3 percent by weight of polyolefins complying with § 177.1520 of this chapter, for use in contact with food of types III, IV-A, V, VII-A, and IX under conditions of use C through G as described in tables 1 and 2 of § 176.170(c) of this chapter. Bis(2,4-di-tert-butyl-6-methylphenyl) ethyl For use only: phosphite (CAS Reg. No. 145650±60±8). 1. At levels not to exceed 0.3 percent by weight of olefin polymers 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. 32687±78±8). 1. As provided in § 175.105 of this chapter. 2. At levels not exceeding 0.1 percent by weight of acrylonitrile-butadiene- styrene copolymers used in accordance with parts 175, 176, 177, and 181 of this chapter. 3. At levels not exceeding 0.1 percent by weight of polyoxymethylene co- polymers complying with § 177.2470 of this chapter and of polyoxymethylene homopolymers complying with § 177.2480 of this chap- ter.
345
VerDate 06
Substances Limitations
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 0.1 percent by weight of olefin polymers com- diphosphaspiro[5.5]undecane (CAS Reg. No. plying with § 177.1520(c) of this chapter, items 1.1, 1.2, or 1.3, and items 154862±43±8). 2.1, 2.2, 2.3, 3.1, or 3.2 (where density of each of these polymers is greater than 0.94 gram per cubic centimeter) and under conditions of use C, D, E, F, and G as described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.06 percent by weight of olefin copolymers com- plying with § 177.1520(c) of this chapter, item 3.1 or 3.2, having a density less than 0.94 gram per cubic centimeter and under conditions of use C, D, E, F, and G as described in table 2 of § 176.170(c) of this chapter. 5,7-bis(1,1-dimethylethyl)-3-hydroxy-2(3H)- For use only: benzofuranone, reaction products with o-xylene 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- (CAS Reg. No. 181314±48±7). plying with § 177.1520(c) of this chapter. The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, Table 1, under Categories I, II, IV±B, VI±A, VI±B, VII±B, and VIII, and under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.02 percent by weight of 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, and ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or 3.6 (where the density of each of these polymers is at least 0.94 gram per cubic centimeter), or 5. The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, Table 1, under Categories III, IV±A, V, VI±C, VII±A, and IX, and under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter; provided that the finished food-contact articles have a vol- ume of at least 18.9 liters (5 gallons). 3. At levels not to exceed 0.02 percent by weight of ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, or 3.6 (where the density of each of these polymers is less than 0.94 gram per cubic centimeter). The finished 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 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. 90498±90±1). 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, IV±B, VI±A, VI±B, VI±C, VII±B, and VIII under conditions of use A through H described in tables 1 and 2 of § 176.170(c) of this chapter.
346
VerDate 06
Substances Limitations
4-[[4,6-Bis(octylthio)-s-triazin-2-yl]amino]-2,6-di- For use only: tert-butylphenol (CAS Reg. No. 991±84±4). 1. At levels not to exceed 0.5 percent by weight: in styrene block 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. 10081±67±1). complying with § 177.1520(c) of this chapter. The polypropylene articles are limited to use in contact with non-fatty foods only. Boric acid (CAS Reg. No. 10043±35±3)...... For use only at levels not to exceed 0.16 percent by weight of ethylene- vinyl acetate-vinyl alcohol copolymers complying with § 177.1360(a)(3) and (d) of this chapter. 1,3±Butanediol. Butylated reaction product of p-cresol and For use only: dicyclopentadiene produced by reacting p-cresol 1. As components of nonfood articles complying with §§ 175.105 and and dicyclopentadiene in an approximate mole 177.2600(c)(4)(iii) of this chapter. ratio of 1.5 to 1, respectively, followed by 2. At levels not to exceed 1.0 percent by weight of acrylonitrile/butadiene/ alkylation with isobutylene so that the butyl con- styrene copolymers. The finished copolymers may be used in contact tent of the final product is not less than 18 per- with food of Types I, II, IV±B, VI±A, VI±B, VII±B, and VIII under condi- cent. tions of use B through H, as described in tables 1 and 2 of § 176.170(c) of this chapter, and with food of Types III, IV±A, V, VI±C, VII±A, and IX under conditions of use C through G as described in tables 1 and 2 of § 176. 170(c) of this chapter. Butylated, styrenated cresols produced when For use only: equal moles of isobutylene, styrene, and a 1. As provided in §§ 175.105 and 177.2600 of this chapter. metacresol-paracresol mixture having a no more 2. At levels not to exceed 0.5 percent by weight of polystyrene, rubber- than 3 °C distillation range including 202 °C are modified polystyrene, or olefin polymers complying with § 177.1520 (c) of made to react so that the final product meets this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4, or com- the following specifications: Not less than 95 plying with other sections in parts 174, 175, 176, 177, 178 and § 179.45 percent by weight of total alkylated phenols con- of this chapter, used in articles that contact food only unded the condi- sisting of 13±25 percent by weight of butylated tions described in § 176.170(c) of this chapter, table 2, under conditions m- and p-cresols, 26±38 percent by weight of of use C through G. styrenated m- and p-cresols, 37±49 percent by weight of butylated styrenated m- and p-cresols, and not more than 10 percent by weight total of alkylated xylenols, alkylated o-cresol, alkylated phenol, and alkylated ethylphenol; acidity not more than 0.003 percent; and refractive index at 25 °C of 1.5550±1.5650, as determined by ASTM method D1218±82, ``Standard Test Meth- od for Refractive Index and Refractive Disper- sion of Hydrocarbon Liquids,'' which is 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.
347
VerDate 06
Substances Limitations
2-tert-Butyl-a(3-tert-butyl-4-hydroxyphenyl)-p-cu- For use only: menyl bis(p-nonylphenyl) phosphite; the nonyl 1. As components of nonfood articles complying with §§ 175.105 and group is a propylene trimer isomer and the 177.2600 of this chapter. phosphorus content is in the range 3.8±4.0 2. At levels not to exceed 1.35 percent by weight of natural rubber, buta- weight percent. diene-acrylonitrile, butadiene-acrylonitrile-styrene, and butadiene-styrene polymers that are used in contact with nonalcoholic food at temperatures not to exceed room temperature and that are employed in closure-sealing gaskets complying with § 177.1210 of this chapter or in coatings 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 137± mers complying with § 177.1520(c) of this chapter, provided that the fin- 141 °C. ished polymer contacts foods only of the types identified in Categories I, II, IV-B, VI-A and B, VII-B, and VIII in table 1, § 176.170 of this chapter. 4,4′-Butylidenebis(6-tert-butyl-m-cresol) ...... For use only. 1. As provided in §§ 175.105 and 177.2600 of this chapter. 2. At levels not to exceed 0.5 percent by weight of polypropylene complying with § 177.1520 of this chapter and for use at levels not to exceed 0.3 percent by weight of polyethylene complying with § 177.1520 of this chapter, provided that the finished polypropylene and polyethylene con- tact food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, VI±B, and VIII. Butyric acid, 3,3-bis(3-tert-butyl-4- For use only: hydroxyphenyl)ethylene ester (CAS Reg. No. 1. At levels not to exceed 0.5 percent by weight of olefin copolymers com- 32509±66±3). plying with § 177.1520(c) of this chapter, items 3.1 and 3.2 except that when used in contact with foods described as types III, IV±A, V, VII±A, and IX in table 1 of § 176.170(c) of this chapter, the olefin copolymers may only be used under conditions of use E, F, and G set forth in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.5 percent by weight of olefin polymers 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.
348
VerDate 06
Substances Limitations
Calcium bis[monoethyl(3,5-di-tert-butyl-4-hydroxy- For use only: benzyl)phosphonate] (CAS Reg. No. 65140±91± 1. At levels not to exceed 0.25 percent by weight of polypropylene that 2). complies with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3. 2. At levels not to exceed 0.2 percent by weight of polyethylene and olefin copolymers that comply with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, 3.4, 3.5, and 3.6. Finished polymers having a density less than 0.94 gram per cubic centimeter shall be used in contact with food only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 3. In adhesives complying with § 175.105 of this chapter. 4. At levels not to exceed 0.5 percent by weight of pressure-sensitive 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. 867±13±0). polymers complying with § 177.1630 of this chapter. Cerium stereate (CAS Reg. No. 10119±53±6) ...... For use only at levels not to exceed 0.5 percent by weight in rigid and semirigid vinyl chloride homo± and copolymer articles modified in 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.
349
VerDate 06
Substances Limitations
Cyclic neopentanetetrayl bis(octadecyl phosphite) For use only at levels not to exceed 0.1 percent by weight of ethylene-vinyl (CAS Reg. No. 3806±34±6); the phosphorus acetate copolymers complying with § 177.1350 of this chapter that con- content is in the range of 7.8 to 8.2 weight per- tact food under conditions of use E, F, and G described in table 2 of cent. § 176.170(c) of this chapter. Cyclic neopentanetetrayl bis(octadecyl phosphite) For use only: (CAS Reg. No. 3806±34±6) (which may contain 1. At levels not to exceed 0.25 percent by weight of olefin polymers com- not more than 1 percent by weight of plying with § 177.1520(c) of this chapter, items 1.1, 2.1, and 3.1. triisopropanolamine (CAS Reg. No. 122±20±3)); 2. At levels not to exceed 0.25 percent by weight of olefin polymers com- the phosphorus content is in the range of 7.8 to plying with § 177.1520(c) of this chapter, item 2.2, that contact food 8.2 weight percent. Types I, II, VI-A, VII-B, and VIII described in table 1 of § 176.170(c) of this chapter under conditions of use B (for boil-in-bag applications), C, D, E, F, G, and H described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.15 percent by weight of olefin polymers 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°±62 °C as determined by ASTM method the finished food-contact article shall not exceed a total of 0.5 milligram E324±79, ``Standard Test Method for Relative per square inch of food-contact surface. Initial and Final Melting Points and the Melting Range of Organic Chemicals,'' and a saponifica- tion value in the range 176±183 as determined by ASTM method D1962±67 (Reapproved 1979), ``Standard Test Method for Saponification Value of Drying Oils, Fatty Acids, and Polym- erized Fatty Acids,'' which are incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Wash- ington, DC 20408. Didodecyl± 1,4±dihydro±2,6±dimethyl±3,5± For use only at levels not to exceed 0.3 percenmt by weight in rigid poly- pyridinedicarboxylate (CAS Reg. No. 36265±41± mer articles modified in accordance with § 178.3790 that contact food, 5). under conditions of use E, F, and G described in table 2 of § 176.170 of this chapter. 2,6-Di(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. 1817±68±1]. mers complying with item 3.4 in § 177.1520(c) of this chapter, provided that such olefin polymers are limited to use at a level not to exceed 25 percent by weight in other olefin polymers complying with § 177.1520 of this chapter; and the total amount in such finished olefin polymers not to exceed 0.05 percent by weight, including the level that may be contrib- uted by its presence at 6 percent in the item ``butylated, styrenated cresols * * * '' listed in this paragraph; and further provided that the 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. 134701±20±5). 1. At levels not to exceed 0.3 percent by weight of acrylonitrile-butadiene- styrene copolymers used in accordance with applicable regulations in parts 175, 176, 177, and 181 of this chapter, under conditions of use C through H as described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.033 percent by weight of rigid polyvinyl 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. 65447±77±0). plying with § 177.1520 of this chapter and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.3 percent by weight of ethylene-vinyl acetate copolymers complying with § 177.1350 of this chapter and under condi- tions of use B through H described in table 2 of § 176.170(c) of this chap- ter.
350
VerDate 06
Substances Limitations
Dimethyltin/monomethyltin For use only at levels not to exceed 2 percent by weight: isooctylmercaptoacetates consisting of 5 to 90 1. In rigid polyvinyl chloride used in the manufacture of pipes intended for percent by weight of monomethyltin tris contact with water in food-processing plants, and (isooctylmercaptoacetate) (CAS Reg. No. 2. In rigid polyvinyl chloride and in rigid vinyl chloride copolymers complying 54849±38±6) or monomethyltin tris(2- with § 177.1950 of this chapter or § 177.1980 of this chapter for use in ethylhexylmercaptoacetate) (CAS Reg. No. contact with food of Types I, II, III, IV (except liquid milk), V, VI, VII, VIII, 57583±34±3) and 10 to 95 percent by weight of and IX described in table 1 of § 176.170(c) of this chapter under condi- dimethyltin bis (isooctylmercaptoacetate) (CAS tions of use C through G described in table 2 of § 176.170(c) of this Reg. No. 26636±01±1) or dimethyltin bis(2± chapter at temperatures not to exceed 88 °C (190 °F). ethylhexylmercaptoacetate) (CAS Reg. No. 57583±35±4), and no more than 0.4 percent by weight of trimethyltin compounds, and having the following specifications: Tin content (as Sn) in the range of 15 to 21 percent and mercaptosulfur content in the range of 11 to 13.5 percent. Other alkyltin compounds are not to exceed 20 ppm. Dimyristyl thiodipropionate having a melting point Finished food-contact articles containing this additive shall meet the extrac- of 48°±52 °C as determined by ASTM method tives limitations prescribed in § 176.170(c) of this chapter. E324±79, ``Standard Test Method for Relative Initial and Final Melting Points and the Melting Range of Organic Chemicals,'' and a saponifica- tion equivalent in the range 280±290 as deter- mined by ASTM method D1962±67 (Re- approved 1979), ``Standard Test Method for Sa- ponification Value of Drying Oils, Fatty Acids, and Polymerized Fatty Acids,'' which are 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. 10039±33±5] having 12.5 to 15.0 percent by copolymers complying with §§ 177.1020 and 177.1030 of this chapter and weight of tin (Sn) and having a saponification used in contact with all food types under conditions of use C through G number of 260 to 280. The additive is made described in table 2 of § 176.170(c) of this chapter. from di(n-octyl)tin oxide meeting the 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. 147315±50±2). 1. At levels not to exceed 0.5 percent by weight of polycarbonate resins complying with § 177.1580 of this chapter. 2. At levels not to exceed 0.5 percent by weight of polyester elastomers complying with § 177.1590 of this chapter. 3. At levels not to exceed 0.5 percent by weight of polyethylene phthalate polymers complying with § 177.1630 of this chapter, in contact with food under conditions of use A through H described in Table 2 of § 176.170(c) of this chapter. 2,6-Di-tert-butyl-4-ethylphenol ...... For use only in contact with nonalcoholic foods: 1. At levels not exceeding 0.04 mg/in 2 of food contact surface and not 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.
351
VerDate 06
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. 178358± 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- 58±2) produced by the condensation of 2,4-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. 119345± 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- 01±6) produced by the condensation of 2,4-di- plying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 3.2b, 3.3a, tert-butylphenol with the Friedel-Crafts addition 3.3b, 3.4, 3.5, and 3.1a (where the density is not less than 0.85 gram per product (phosphorus trichloride and biphenyl) so cubic centimeter and not more than 0.91 gram per cubic centimeter); and that the food additive has a minimum phos- 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, and 3.6 (where the density is not less than phorus content of 5.4 percent, an acid value not 0.94 gram per cubic centimeter) and 5. exceeding 10 mg KOH/gm, and a melting range 2. At levels not to exceed 0.1 percent by weight of polycarbonate resins of 85 °C to 110 °C (185 °F to 230 °F). complying with § 177.1580 of this chapter. 3. At levels not to exceed 0.2 percent by weight of polystyrene and 0.3 per- cent by weight of rubber±modified polystyrene complying with § 177.1640 of this chapter. 4. At levels not to exceed 0.15 percent by weight of olefin polymers 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. 4221±80±1). 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, IV±B, VI±A, VI±B, VII±B, and VIII, identified in table 1 of § 176.170(c) of this chapter; and (2) when used in repeated-use articles that contact food of types I, II, III, IV, V, VI, VII, VIII, and IX identified in table 1 of § 176.170(c) of this chapter. The additive is used under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.25 percent by weight of olefin polymers having a density of not less than 0.94 gram per cubic centimeter and complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 3.1, and 3.2: (1) when used in single-use articles that contact food of types I, II, IV±B, VI±A, VI± B, VII±B, and VIII, identified in table 1 of § 176.170(c) of this chapter; and (2) when used in repeated-use articles that contact food of types I, II, III, IV, V, VI, VII, VIII, and IX identified in table 1 of § 176.170(c) of this chap- ter. The additive is used under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2,4-Di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2- For use only: hydroxyphenyl)ethyl]phenyl acrylate (CAS Reg. 1. At levels not to exceed 0.2 percent by weight of polypropylene complying No. 123968-25-2). with § 177.1520 of this chapter. The additive is used under conditions of use D through G described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.5 percent by weight of styrene block polymers complying with § 177.1810 of this chapter. The additive is used under conditions of use D through G described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.5 percent by weight of polystyrene and rubber- modified polystyrene complying with § 177.1640 of this chapter in contact with all food types under conditions of use D through G as described in table 2 of § 176.170(c) of this chapter.
352
VerDate 06
Substances Limitations
Ethylenebis(oxyethylene)-bis-(3-tert-butyl-4-hy- 1. At levels not to exceed 0.3 percent by weight of polystyrene and/or rub- droxy-5-methylhydrocinnamate) (CAS Reg. No. ber modified polystyrene polymers complying with § 177.1640 of this 36443±68±2). chapter. 2. At levels not to exceed 0.3 percent by weight of acrylonitrile-butadiene- styrene copolymers used in accordance with applicable regulations in parts 175, 176, 177, and 181 of this chapter. 3. At levels not to exceed 0.75 percent by weight of polyoxymethylene 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. 2,2′-Ethylidenebis(4,6-di-tert-butylphenol) (CAS For use only: Reg. No. 35958±30±6). 1. At levels not to exceed 0.1 percent by weight of olefin polymers 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.
353
VerDate 06
Substances Limitations
2,2′-Ethylidenebis(4,6-di-tert- For use only: butylphenyl)fluorophosphonite (CAS Reg. No. 1. As provided in § 175.105 of this chapter. 118337±09±0). 2. In all polymers used in contact with food of types I, II, IV±B, VI±A, VI±B, VII±B, and VIII, under conditions of use B through H described in Tables 1 and 2 of § 176.170(c) of this chapter at levels not to exceed 0.25 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, IV±A, V, VII±A, and IX, under: (a) Conditions of use B through H described in Tables 1 and 2 of § 176.170(c) of this chapter at levels not to exceed 0.25 percent by weight of the polymer; or (b) Condition of use A, limited to levels not to exceed 0.1 percent by weight of the polymer; provided that the food-contact surface has an average thickness not exceeding 375 micrometers (0.015 inch). 4. In olefin copolymers complying with § 177.1520(c) of this chapter, items 3.1a or 3.2a, and containing not less than 85 percent by weight of poly- mer units derived from propylene, in contact with food of types III, IV±A, V, VII±A, and IX, and under: (a) Conditions of use C through G, described in Tables 1 and 2 of § 176.170(c) of this chapter, limited to levels no greater than 0.2 percent by weight of the copolymers; or (b) Conditions of use A, B, and H, limited to levels no greater than 0.1 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, IV±A, V, VII±A, 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, IV±A, V, VII±A, and IX, and under: (a) Conditions of use B through H, described in Tables 1 and 2 of § 176.170(c) of this chapter limited to levels not to exceed 0.2 percent by weight of the polymers; or (b) Condition of use A, described in Tables 1 and 2 of § 176.170(c) of this chapter, limited to levels not to exceed 0.1 percent by weight of the 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, IV±A, V, VII±A, and IX, and under: (a) Conditions of use C through G, described in Tables 1 and 2 of § 176.170(c) of this chapter limited to levels not to exceed 0.2 percent by weight of the copolymers; or (b) Conditions of use A, B, and H, limited to levels not to exceed 0.1 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, IV± A, V, VII±A, and IX, under conditions of use A through H, as described in Tables 1 and 2 of § 176.170(c) of this chapter at levels not to exceed 0.1 percent by weight of the copolymer; provided that the food-contact 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, IV±A, V, VI±C, VII±A, and IX, and under: (a) Conditions of use B through H, described in tables 1 and 2 of § 176.170(c) of this chapter, limited to levels not to exceed 0.3 percent by weight of the polymers; or (b) Condition of use A with food of types III, IV±A, V, VII±A, and IX, and limited to levels not to exceed 0.1 percent by weight of the polymers; 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. 67845±93±6). mers complying with § 177.1520 of this chapter.
354
VerDate 06
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 23128±74±7). with § 177.1500(b) of this chapter, items 1 through 8, that contact food only of the types identified in categories in § 176.170(c) of this chapter, table 1 except VI±A and VI±C. 2. At levels not to exceed 0.75 percent by weight of nylon 12 resins 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 VI±A and VI±C. 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. 1,6±Hexanediamine, N, N′-bis(2,2,6,6-tetramethyl- For use only as a stabilizer at levels not to exceed 0.3 percent by weight of 4-piperidinyl)-, polymers with morpholine-2,4,6- olefin polymers complying with § 177.1520(c) of this chapter. The finished trichloro-1,3,5-triazine reaction products, polymers are to contact food only under conditions of use C, D, E, F, and methylated (CAS Reg. No. 193098±40±7). G, as described in Table 2 of § 176.170(c) of this chapter. Provided that the finished food-contact articles have a volume of at least 18.9 liters (5 gallons). 2-Hydroxy-4-isooctoxy-benzophenone. Chemical For use only at levels not to exceed 0.5 percent by weight of olefin copoly- Abstracts (CA) name: Methanone, [2-hydroxy-4- mers complying with § 177.1520(c) of this chapter: Items 1.1, 1.2, 1.3, (isooctyloxy) phenyl]phenyl; CA Registry No. 2.1, 2.2, 2.3, 3.1, 3.2, 3.3 or 4: Provided, That the finished polymer con- 330:59±05±1. tacts food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, VII-B and VIII under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter.
355
VerDate 06
Substances Limitations
2(2′-Hydroxy-5′-methylphenyl)benzotriazole meet- For use only: ing the following specification: melting point 1. As component of nonfood articles complying with § 177.1010 of this 126° ±132 °C (258.8° ±269.6 °F) (CAS Reg. No. chapter. 2440±22±4). 2. At levels not to exceed 0.25 percent by weight of rigid polyvinyl chloride and/or rigid vinyl chloride copolymers complying with § 177.1980 of this chapter. 3. In polystyrene that complies with § 177.1640 of this chapter and that is limited to use in contact with dry food of Type VIII described in table 1 of § 176.170(c) of this chapter. 4. At levels not to exceed 0.25 percent by weight of polystyrene and/or 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, VI±A, VI± B, VII, VIII, and IX identified in table 1 of § 176.170(c) of this chapter and under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. 6. At levels not to exceed 0.5 percent by weight of ethylene-1,4- cyclohexylene dimethylene terephthalate copolymers complying with § 177.1315 of this chapter and of ethylene phthalate polymers complying with § 177.1630 of this chapter and that contact food only under 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 5.2±5.6 weight percent. §§ 177.1950, 177.1970 or 177.1980 of this chapter, and used in contact with food, except milk, only under the conditions described in § 176.170(c) of this chapter, table 2, under conditions of use D through G. Magnesium salicylate ...... For use only in rigid polyvinyl chloride and/or in rigid vinyl chloride 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. 110553±27±0). 1. In adhesives complying with § 175.105 of this chapter. 2. At levels not to exceed 0.5 percent by weight of can-end cements and side-seam cements complying with § 175.300(b)(3)(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, petroleum 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 0.5 percent by weight of finished rubber products 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 rosin derivatives complying with § 178.3800 of this chapter. 6. At levels not to exceed 0.2 percent by weight of styrene block polymers complying with § 177.1810 of this chapter that contact food of Types I, II, IV±B, VI, VII±B, and VIII described in table 1, § 176.170(c) of this chap- ter, only under conditions of use C through H described in table 2, § 176.170(c) of this chapter.
356
VerDate 06
Substances Limitations
2,2′-Methylenebis(4,6-di-tert-butylphenyl)2- For use only at levels not to exceed 0.25 percent by weight of poly- ethylhexyl phosphite (CAS Reg. No. 126050± propylene complying with § 177.1520 of this chapter. The finished poly- 54±2). mers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV±B, VI±B, VII±B, and VIII under conditions of use B through H described in table 2, § 176.170(c) of this chapter, and with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories III, IV±A, V, VI±A, VI±C, VII±A, and IX under conditions of use C through G described in table 2, § 176.170(c) of this chapter. 2,2′-Methylenebis (6-tert-butyl-4-ethylphenol) ...... For use only: 1. In acrylonitrile-butadiene-styrene copolymers at levels not to exceed 0.6 percent by weight of the copolymer. 2. In semirigid and rigid acrylic and modified acrylic plastics complying with § 177.1010 of this chapter at levels not to exceed 0.1 percent by weight of the plastic. 4,4′-Methylenebis (2,6-di-tert-butyl-phenol) ...... For use only: 1. As provided in § 175.105 of this chapter. 2. At levels not to exceed 0.25 percent by weight of petroleum hydrocarbon resins used in compliance with regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter. 3. At levels not to exceed 0.25 percent by weight of terpene resins used in compliance with regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter. 4. At levels not to exceed 0.5 percent by weight of polyethylene complying with § 177.1520 of this chapter: Provided, That the polyethylene end product contacts foods only of the types identified in Categories I, II, IV- B, VI, VII-B, and VIII in table 1, § 176.170(c) of this chapter. 5. At levels not to exceed 0.5 percent by weight of polybutadiene used in rubber articles complying with § 177.2600 of this chapter: Provided, That the rubber end product contacts foods only of the types identified in Cat- egories I, II, IV-B, VI, VII-B, and VIII in table 1, § 176.170(c) of this 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. 61167±58±6). 1. At levels not to exceed 0.5 percent by weight of polystyrene and rubber- modified polystyrene complying with § 177.1640 of this chapter. 2. At levels not to exceed 0.5 percent by weight of styrene block ploymers complying with § 177.1810 of this chapter. 3. At levels not to exceed 1 percent by weight of adhesives complying with § 175.105 of this chapter and pressure sensitive adhesives complying with § 175.125 of this chapter. 4. At levels not to exceed 0.5 percent by weight of acrylonitrile-butadiene- styrene copolymers that comply with § 177.1020 of this chapter when used in articles that contact food only under conditions of use E, F, and G as described in table 2, § 176.170 (c) of this chapter. 2,2′-Methylenebis[6-(1-methylcyclo-hexyl)-p-cresol] For use only: 1. As provided in § 177.1210 of this chapter. 2. At levels not to exceed 0.2 percent by weight of polyethylene complying with § 177.1520 of this chapter: Provided, That the finished polyethylene contacts foods only of the type identified in § 176.170(c) of this chapter, table 1, under Categories I, II, VI±B, and VIII. 3. In polyethylene complying with § 177.1520 of this chapter: Provided, That the finished polyethylene contacts foods only of the types identified in § 176.170(c) of this chapter, table 1, under Categories III, IV, V, VI-A, VII, and IX, and only at temperatures not to exceed room temperature: And further provided, That percentage concentration of the antioxidant in the polyethylene, when multiplied by the thickness in inches of the finished polyethylene, shall not be greater than 0.0005. 2,2′-Methylenebis(4-methyl-6-nonylphenol) and For use only in acrylonitrile-butadiene-styrene copolymers used in contact 2,6-bis(2-hydroxy-3-nonyl-5-methyl-benzyl)-p- with nonalcoholic foods. cresol mixtures (varying proportions). 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.
357
VerDate 06
Substances Limitations
Nylon 612/6 copolymer. (CAS Reg. No. 51733± For use only at levels not to exceed 1.5 percent by weight of 10±9), weight ratio 6/1. polyoxymethylene homopolymer as provided in § 177.2480(b)(1). Octadecyl 3,5-di-tert-butyl-4- For use only: hydroxyhydrocinnamate (CAS Reg. No. 2082± 1. At levels not exceeding 0.25 percent by weight of olefin polymers com- 79±3). plying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4. 2. As provided in §§ 175.105 and 177.1010(a)(5) of this chapter. 3. At levels not exceeding 0.25 percent by weight of polystyrene and/or 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, IV±B, 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, IV±B, VI, VII± B, and VIII. 6. At levels not exceeding 0.05 percent by weight of modified semi-rigid and rigid vinyl chloride plastics modified with methacrylate-butadiene-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, IV±B, VI, VII±B, and VIII, and under conditions of use D, E, F, and G described in table 2 of § 176.170(c) of this chapter. 12. At levels not exceeding 0.2 percent by weight of vinylidene chloride homopolymers and/or vinylidene chloride copolymers complying with 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. Oxidized bis (hydrogenated tallow alkyl) amines ..... For use only: 1. At levels not to exceed 0.1 percent by weight of polypropylene polymers complying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 3.1a (density not less than 0.85 gram per cubic centimeter and less than 0.91 gram per cubic centimeter), 3.2b, 3.4, and 3.5. The finished polymers may be used in contact with food types I, II, IV±B, VII±B and VIII 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, IV±A, V, VI, VII±A, and IX described in table 1 of § 176.170(c) of this chapter, under conditions of use D through H 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, IV±B, VII±B and VIII described in table 1 of § 176.170(c) of this chapter, under conditions of use B through H described in table 2 of § 176.170(c) of this chapter, and with food types III, IV±A, V, VI, VII±A and IX described in table 1 of § 176.170(c) of this chapter, under condi- tions of use D through H described in table 2 of § 176.170(c) of this chapter.
358
VerDate 06
Substances Limitations
2,2′-Oxamidobis[ethyl 3-(3,5-di-tert-butyl-4- For use only: hydroxyphenyl)propionate] (CAS Reg. No. 1. At levels not to exceed 0.5 percent by weight of polystyrene and rubber- 70331±94±1). modified polystyrene complying with § 177.1640 of this chapter. 2. At levels not to exceed 0.5 percent by weight of olefin polymers 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, IV±B, VI, VII±B 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, IV±A, V, VII±A, 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, VII±A, 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. 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. 68411± adhesives complying with § 175.125 of this chapter. 46±1). Phosphoric acid triesters with triethylene glycol At levels not to exceed 0.1 percent by weight of polyethylene phthalate (CAS Reg. No. 64502±13±2). polymers complying with § 177.1630 of this chapter, such that the poly- mers contact foods only of Type VI±B described in table 1 of § 176.170(c) of this chapter. Phosphorous acid, cyclic butylethyl propanediol, For use only: 2,4,6-tri-tert-butylphenyl ester (CAS Reg. No. 1. At levels not to exceed 0.2 percent by weight of olefin polymers com- 161717±32±4), which may contain not more plying with § 177.1520(c) of this chapter, items 1.1, 1.2, or 1.3, and items than 1 percent by weight of triisopropanolamine 2.1, 2.2, or 2.3 (where the density of these polymers is not less than 0.94 (CAS Reg. No. 122±20±3). gram per cubic centimeter), and items 3.1 or 3.2, provided that the fin- ished polymer contacts foods of types I, II, and VI±B as described in table 1 of § 176.170(c) of this chapter only under conditions of use B, C, D, E, F, G, and H as described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.1 percent by weight of olefin polymers 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, VI±A, VI±C, VII, VIII, and IX as described in table 1 of § 176.170(c) of this chapter, only under conditions of use C, D, E, F, and G as described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.1 percent by weight of olefin copolymers 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, VI±A, VI±C, VII, VIII, and IX and under conditions of use B, C, D, E, F, G, and H as described in tables 1 and 2 of § 176.170(c) of this chapter; provided that the food-contact surface does not exceed 0.003 inch (0.076 mm) in thickness. 4. At levels not to exceed 0.1 percent by weight of olefin polymers 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, VI±A, VI±C, VII, VIII, and IX identified in Table 1 of § 176.170(c) of this chapter, and under conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter; provided that the food-contact surface does not exceed 0.003 inch (0.076 mm) in thickness. Phosphorous acid, cyclic neopentanetetrayl For use only at levels not to exceed 0.10 percent by weight of olefin poly- bis(2,4-di-tert-butylphenyl) ester (CAS Reg. No. mers complying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 2.1, 26741±53±7) which may contain not more than 2.2, 2.3, 3.1, or 3.2, and limited to use in contact with food only under 1 percent by weight of triisopropanolamine (CAS conditions of use B, C, D, E, F, G, and H described in table 2 of Reg. No. 122±20±3). § 176.170(c) of this chapter. Olefin polymers that contain more than 50 weight-percent of polymer units derived from ethylene shall have a den- sity equal to or greater than 0.94 gram per cubic centimeter.
359
VerDate 06
Substances Limitations
Phosphorous acid, cyclic neopentanetetrayl bis For use only: (2,6-di-tert-butyl-4-methylphenyl)ester (CAS 1. At levels not to exceed 0.25 percent by weight of polypropylene Reg. No. 80693±00±1). homopolymer and copolymers complying with § 177.1520 of this chapter, for use with all food types described in table 1 of § 176.170(c) of this chapter only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.05 percent by weight of polymers complying with § 177.1520(c) of this chapter, item 3.1 or 3.2, and with a maximum thickness of 100 micrometers (0.004 inch) for use with all food types under conditions of use B, C, D, E, F, G, and H described in table 2 of § 176.170(c) of this chapter. Phosphorous acid, cyclic neopentanetetrayl For use only: bis(2,4-di-tert-butylphenyl)ester (CAS Reg. No. 1. At levels not to exceed 0.86 percent by weight in polyvinyl chloride and/ 26741±53±7). or vinyl chloride copolymers that comply with §§ 177.1950, 177.1960, 177.1970, or 177.1980 of this chapter for use with all food types 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 VII±A described in table 1 of § 176.170(c) of this chapter shall not exceed 80 micrometers (0.003 inch). Poly(1,4-cyclohexylenedimethylene-3,3′- For use only: thiodipropionate) partially terminated with stearyl 1. In polypropylene complying with § 177.1520(c) of this chapter, item 1.1, alcohol and produced when approximately equal and used in contact with nonfatty, nonalcoholic food. moles of 1,4-cyclohexanedimethanol and 3,3′- 2. At levels not to exceed 0.5 percent by weight of polypropylene complying thiodipropionic acid are made to react in the with § 177.1520(c) of this chapter, item 1.1, and used in contact with presence of stearyl alcohol so that the final fatty, nonalcoholic food. The average thickness of such polymers in the product has an average molecular weight in the form in which they contact fatty nonalcoholic food shall not exceed 0.005 range of 1,800±2,200, as determined by vapor inch. pressure osmometry, and has a maximum acid value of 2.5. Poly[(1,3-dibutyldistannthianediylidene)-1,3-dithio] For use only at levels not to exceed 0.2 by percent weight in polyvinyl chlo- having the formula [C8H18Sn2S3]n (where n ride resin where such resin constitutes not less than 98.7 percent of a averages 1.5±2) 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 130±145 °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 20.5±22.0 percent; tin content in this stabilizer, when extracted with refined cottonseed oil at 120 °F for 48 the range 52.0±53.2 percent. hours, using a volume-to-surface ratio of 2 milliliters per square inch of surface tested, shall yield tin (Sn) not to exceed 0.0005 milligram per square inch of food-contact surface. Poly[(6-morpholino-s-triazine-2,4-diyl)[(2,2,6,6- For use only: tetramethyl-4-piperidyl)imino]hexamethylene 1. At levels not to exceed 0.3 percent by weight of polypropylene complying [(2,2,6,6-tetramethyl-4-piperidyl)imino]] (CAS with § 177.1520(c) of this chapter, items 1.1,1.2, and 1.3, and of ethylene Reg. No. 82451±48±7). 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.
360
VerDate 06
Substances Limitations
Poly[[6-[(1,1,3,3-tetramethybutyl) amino]-s-triazine- For use only: 2,4-diyl][2,2,6,6-tetramethyl-4- 1. At levels not to exceed 0.3 percent by weight of polypropylene complying piperidyl)imino]hexamethylene[(2,2,6,6- with § 177.1520 of this chapter. tetramethyl-4-piperidyl)imino]] (CAS Reg. No. 2. At levels not to exceed 0.2 percent by weight of polyethylene complying 70624±18±9). with § 177.1520 of this chapter, that has a density equal to or greater than 0.94 gram per cubic centimeter. 3. At levels not to exceed 0.3 percent by weight of polyethylene that has a density less than 0.94 gram per cubic centimeter complying with § 177.1520 of this chapter, items 2.1, 2.2, and 2.3, and of olefin polymers and copolymers complying with items 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, and 4. The finished polymers are to contact food only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter, and when contacting fatty foods of Types III, IV±A, V, VII±A, and IX described in table 1 of § 176.170(c) of this chapter, the finished articles are to have a volume of at least 18.9 liters (5 gallons). 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. N,N′-1,3-Propanediylbis (3,5-di-tert-butyl-4- For use only at levels not to exceed 0.6 percent by weight of rubber articles hydroxyhydrocinnamamide) (CAS Reg. No. for repeated use complying with § 177.2600 of this chapter. 69851±61±2). Stearoylbenzoylmethane (CAS Reg. No. 58446± For use only at levels not to exceed 0.5 percent by weight of vinyl chloride 52±9) consisting of a mixture of β±diketones homopolymers modified in accordance with § 178.3790(b)(1). The fin- produced by the condensation of acetophenone ished polymers may be used in contact with food containing up to 50 per- and technical methyl stearate.. cent alcohol under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. Styrenated diphenylamine (CAS Reg. No. 68442± For use only in adhesives complying with § 175.105 of this chapter and in 68±2). rubber articles intended for repeated use complying with § 177.2600 of this chapter. 2-[[2,4,8,10-Tetrakis(1,1- For use only at levels not to exceed 0.075 percent by weight of olefin co- dimethylethyl)dibenzo[d,f][1,3,2]- polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, dioxaphosphepin-6-yl]oxy]-N,N-bis[2-[[2,4,8,10- 1.3, 2.1, 2.2, or 2.3: Provided, That the density of the olefin polymers tetrakis(1,1- complying with items 2.1, 2.2, or 2.3 is not less than 0.94 gram per cubic dimethylethy- centimeter: And further provided, That the finished polymers contact food l)dibenzo[d,f][1,3,2]dioxaphosphepin-6- only of Types I, II, IV±B, VI±A, VI±B, VII±B, and VIII described in table 1, yl]oxy]ethyl]ethanamine (CAS Reg. No. 80410± of § 176.170(c) of this chapter, under conditions of use B through H de- 33±9). scribed in table 2 of § 176.170(c) of this chapter and food only of Types III, IV±A, V, VI±C, VII±A, and IX described in table 1 of § 176.170(c) of this chapter, under conditions of use C through G described in table 2 of § 176.170(c) of this chapter. 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. 6683±19±8). direct additives in food packaging, except as specified below. 2. At levels not to exceed 0.1 percent by weight of petroleum wax or 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.
361
VerDate 06
Substances Limitations
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, VI±B, and VIII. Thiodiethylene bis(3,5-di-tert-butyl-4- For use only: hydroxyhydrocinnamate) (CAS Reg. No. 41484- 1. In adhesives complying with § 175.105 of this chapter. 35-9). 2. At levels not to exceed 0.5 percent by weight of pressure-sensitive 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. 1709± 1. At levels not to exceed 0.5 percent by weight of polymers except nylon 70±2). resins identified in § 177.1500 of this chapter. 2. At levels not to exceed 1 percent by weight of nylon resins identified in § 177.1500 of this chapter. Tri(mixed mono-and dinonylphenyl) phosphite (which may contain not more than 1 percent by weight of triisopropanolamine).. 1, 11-(3, 6, 9-Trioxaundecyl) bis-3-(dodecylthio) For use only as provided in § 175.300(b)(3)(xxxi) of this chapter at 4.0 parts propionate (CAS Reg. No. 64253±30±1).. per 100 parts rubber. 1,3,5-Tris(3,5-di-tert-butyl-4-hydroxybenzyl)-s-tri- For use only: azine-2,4,6(1H,3H,5H)trione (CAS Reg. No. 1. At levels not to exceed 0.25 percent by weight of polypropylene com- 27676±62±6). plying with § 177.1520 of this chapter. 2. In polyethylene complying with § 177.1520 of this chapter: (a) At levels not to exceed 0.1 weight percent. (b) At levels not to exceed 0.5 weight percent in contact with nonfatty food. 3. At levels not to exceed 0.5 percent by weight of ethylene-propylene-5- ethylidine-2-norbornene terpolymers complying with § 177.1520 of this chapter. The maximum thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 4. At levels not exceeding 0.1 percent by weight of olefin copolymers 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. 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. 40601±76±1]. plying with § 177.1520 of this chapter, under conditions of use A through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.1 percent by weight of polystyrene and rubber- modified polystyrene that comply with § 177.1640 of this chapter, 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.
362
VerDate 06
Substances Limitations
Tris(2,4-di-tert-butylphenyl)phosphite. (CAS Reg. For use only: No. 31570±04±4). 1. At levels not to exceed 0.5 percent by weight of elastomers used in 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.
363
VerDate 06
Substances Limitations
Tris(2-methyl-4-hydroxy-5-tert-butylphenyl)butane For use only: (CAS Reg. No. 1843±03±4). 1. At levels not to exceed 0.25 percent by weight of polymers used as 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, IV±B, VI±B, VII±B, 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, IV±A, V, VI±A, VI±C, VII±A, and IX described in table 1 of § 176.170(c) of this chapter: Olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4 or complying with other sections in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter; vinyl chloride polymers; and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. 4. As provided in § 175.105 of this chapter. 5. At levels not to exceed 0.2 percent by weight of polystyrene and/or 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. 136± For use only: 23±2). 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 in the Finding Aids section of this volume.
§ 178.2550 4-Hydroxymethyl-2,6-di-tert- levels not to exceed a total of 3 parts butylphenol. per hundred of resin, as stabilizers in 4-Hydroxymethyl-2,6-di-tert-butyl- vinyl chloride homopolymers and co- phenol may be safely used as an anti- polymers complying with the provi- oxidant in articles intended for use in sions of § 177.1950 or § 177.1980 of this contact with food, in accordance with chapter and that are identified for use the following prescribed conditions: in contact with food of types I, II, III, (a) The additive has a solidification IV (except liquid milk), V, VI (except point of 140°–141 °C. malt beverages and carbonated non- (b) The concentration of the additive alcoholic beverages), VII, VIII, and IX and any other permitted antioxidants described in table 1 of § 176.170(c) of this in the finished food-contact article chapter, except for the organotin does not exceed a total of 0.5 milligram chemical identified in paragraph (a)(3) per square inch of food-contact surface. of this section, which may be used in contact with food of types I through IX § 178.2650 Organotin stabilizers in at temperatures not exceeding 75 °C vinyl chloride plastics. (167 °F), and further that the organotin The organotin chemicals identified in chemicals identified in paragraphs (a) paragraph (a) of this section may be (5) and (6) of this section may be used safety used alone or in combination, at in contact with food of types I through
364
VerDate 06
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 oxide has an organotin composition (5) Bis(beta-carbobutoxyethyl)tin that is not less than 95 percent by bis(isooctylmercaptoacetate) (CAS weight of di(n-octyl)tin oxide and not Reg. No. 63397–60–4) is an estertin more than 5 percent by weight of chemical having 14.0 to 15.0 percent by bis[tri(n-octyl)tin] oxide, and/or mono weight of tin (Sn) and having 7.5 to 8.5 n-octyltin oxide. percent by weight of mercapto sulfur. (2) Di(n-octyl) tin maleate polymer is It is made from bis(beta- an octyltin chemical having the for- carbobutoxyethyl)tin dichloride. The isooctyl radical in the mercaptoacetate mula [(C8H17)2SnC4H2O4]n (where n is between 2 and 4 inclusive), having 25.2 is derived from oxo process primary to 26.6 percent by weight of tin (Sn) octyl alcohols. The bis(beta- and having a saponification number of carbobutoxyethyl)tin dichloride has an 225 to 255. It is made from di(n- organotin composition that is not less octyl)tin dichloride or di(n-octyl)tin than 95 percent by weight of bis(beta- oxide meeting the specifications pre- carbobutoxyethyl)tin dichloride and scribed for di(n-octyl) tin dichloride or not more than 5 percent by weight of di(n-octyl) tin oxide in paragraph (a)(1) bis(beta-carbobutoxyethyltin tri- of this section. chloride. The triestertin chloride con- (3) C10-16-Alkyl mercaptoacetates re- tent of bis(beta-carbobutoxyethyltin) action products with dichloride shall not exceed 0.02 percent. dichlorodioctylstannane and p trichlorooctylstannane (CAS Reg. No. (6) Beta-carbobutoxyethyltin 83447–69–2) is an organotin chemical tris(isooctylmercaptoacetate) (CAS mixture having 10.8 to 11.8 percent by Reg. No. 63438–80–2) is an estertin weight of tin (Sn) and having 8.0 to 8.6 chemical having 13.0 to 14.0 percent by percent by weight of mercapto sulfur. weight of tin (Sn) and having 10.5 to
365
VerDate 06
11.5 percent by weight of mercapto sul- (ii) Subsequent determinations shall fur. It is made from beta- be at a minimum of 24-hour intervals carbobutoxyethyltin trichloride. The for aqueous solvents, and 2-hour inter- isooctyl radical in the mercaptoacetate vals for heptane. These tests shall yield is derived from oxo process primary total octylin stabilizers not to exceed octyl alcohol. The beta- 0.5 parts per million as determined by carbobutoxyethyltin trichloride has an analytical method entitled ‘‘Atomic organotin composition that is not less Absorption Spectrometric Determina- than 95 percent by weight of beta- tion of Sub-part-per-Million Quantities carbobutoxyethyltin trichloride and of Tin in Extracts and Biological Mate- not more than 5 percent total of rials with Graphite Furnace,’’ Analyt- triestertin chloride and diestertin chlo- ical Chemistry, Vol. 49, p. 1090–1093 ride. (1977), which is incorporated by ref- (7) The dodecyltin stabilizer is a mix- erence.Copies are available from the ture of 50 to 60 percent by weight of n- Center for Food Safety and Applied Nu- dodecyltin S,S′,S″- trition (HFS–200), Food and Drug Ad- tris(isooctylmercaptoacetate) (CAS ministration, 200 C St., SW., Wash- Reg. No. 67649–65–4) and 40 to 50 percent ington, DC 20204, or available for in- by weight of di(n-dodecyl)tin S,S′- spection at the Office of the Federal di(isooctylmercaptoacetate) (CAS Reg. Register, 800 North Capitol Street, No. 84030–61–5) having 13 to 14 percent NW., suite 700, Washington, DC 20408. by weight of tin (Sn) and having 8 to 9 (iii) Subsequent determinations for percent by weight of mercapto sulfur. the dodecyltin mixture described in It is made from a mixture of dodecyltin paragraph (a)(7) of this section shall be trichloride and di(dodecyl)tin dichlo- at a minimum of 24-hour intervals for ride which has not more than 0.2 per- aqueous solvents and 2-hour intervals cent by weight of dodecyltin tri- for heptane. These tests shall yield ′ chloride, not more than 2 percent by di(n-octyl)tin S,S - weight of dodecylbutyltin dichloride bis(isooctylmercaptoacetate), or di(n- octyl)tin maleate polymer, or (C -C )- and not more than 3 percent by weight 10 16 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
366
VerDate 06
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 VI±A ... Ethyl alcohol, 8 pct ...... 24 120 § 178.3120 Animal glue. Type VI±C ... 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. 75± styrene. ployed in the production of animal glue 37±6). 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.
367
VerDate 06
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- (CAS Reg. tended for repeated use in contact with prescribed by such regulation for the No. 55799± dry foods. finished form of the substance or arti- 16±1). cle. (2) It is used as an adhesive or compo- [50 FR 21835, May 29, 1985] nent of an adhesive in accordance with the provisions of § 175.105 of this chap- § 178.3130 Antistatic and/or anti- ter. fogging agents in food-packaging (3) It is used as a colloidal flocculant materials. added to the pulp suspension prior to The substances listed in paragraph the sheet-forming operation in the (b) of this section may be safely used as manufacture of paper and paperboard. antistatic and/or antifogging agents in (4) It is used as a protective colloid in food-packaging materials, subject to resinous and polymeric emulsion coat- the provisions of this section: ings. (a) The quantity used shall not 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.
368
VerDate 06
List of substances Limitations
Alkyl mono- and disulfonic acids, sodium salts (produced from For use only: n-alkanes in the range of C10±C18 with not less than 50 per- 1. As antistatic agents at levels not to exceed 0.1 percent by cent C14±C16).. weight of polyolefin films that comply with § 177.1520 of this chapter: Provided, that the finished olefin polymers contact foods of Types I, II, III, IV, V, VIA, VIB, VII, VIII, and IX 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. 11121±16± For use only: 7) produced by reaction between aluminum oxide and/or alu- 1. At levels not to exceed 1 percent by weight of poly- minum hydroxide with boric acid and/or metaboric acid at propylene films complying with § 177.1520(c) of this chapter, temperatures in excess of 1000 °C. item 1.1, of polyethylene films complying with § 177.1520(c) of this chapter, items 2.1 and 2.2 and having a density greater than 0.94 gram per cubic centimeter, and of polyolefin copolymer films complying with § 177.1520(c) of this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b). The 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 as an antistatic agent at levels not to exceed 0.2 70955±14±5).. percent by weight in molded or extruded high-density poly- ethylene (having a density ≥ 0.95 g/cm3) and polypropylene containers that contact food only of the types identified in § 176.170(c) of this chapter, table 1, under types I, VI-B, VII- B, and VIII, under the conditions of use E through G de- scribed in table 2 of § 176.170(c) of this chapter, provided such foods have a pH above 5.0. 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.
369
VerDate 06
List of substances Limitations
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, VI±B, VII, VIII, and IX described in table 1 of § 176.170(c) of this chapter, and under conditions of use B through H described in table 2 of § 176.170(c) of this 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. 10213±78±2, N-(2-hydroxyethyl)-N- percent by weight in polypropylene films complying with octadecylglycine (monosodium salt), Chemical Abstracts § 177.1520 of this chapter, and used for packaging food of Service Registry No. 66810±88±6, and N,N-Bis(2-hydroxy- Types I, II, III, IV, V, VI±B, VII, VIII, and IX described in table ethyl)-N-(carboxymethyl) octadecanaminum hydroxide (inner 1 of § 176.170(c) of this chapter, and under conditions of use salt), Chemical Abstracts Service Registry No. 24170±14±7, B through H described in table 2 of § 176.170(c). The aver- as the major components of a mixture prepared by reacting age thickness of such polypropylene film shall not exceed ethylene oxide with octadecylamine and further reacting this 0.002 inch. product with sodium monochloroacetate and sodium hydrox- ide, such that the final product has: A nitrogen content of 3.3±3.8 percent; a melting point of 42°±50 °C; and a pH of 10.0±11.5 in a 1 percent by weight aqueous solution. 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. 66822±60±4).. § 176.170(c) of this chapter. The average thickness of such polyolefin film shall not exceed 0.02 centimeter (0.008 inch). Octadecanoic acid 2-[2-hydroxyethyl) octadecylamino]ethyl For use only as an antistatic agent at levels such that the ester (CAS Reg. No. 52497±24±2), (octadecylimino) diethyl- product of film thickness in microns times the weight percent ene distearate (CAS Reg. No. 94945±28±5), and octadecyl additive does not exceed 16, in polypropylene films com- bis(hydroxyethyl)amine (CAS Reg. No. 10213±78±2), as the plying with § 177.1520(c)1.1 of this chapter, and used for major components of a mixture prepared by reacting ethyl- packaging food (except for food containing more than 8 per- ene oxide with octadecylamine and further reacting this prod- cent alcohol) under conditions of use B through H described uct with octadecanoic acid, such that the final product has: a in table 2 of § 176.170(c) of this chapter. maximum acid value of 5 mg KOH/g and total amine value of 86±6 mg KOH/g as determined by a method entitled ``Total Amine Value,'' which is incorporated by reference. Copies of the method are available from the Center for Food Safety and Applied Nutrition (HFS±200), Food and Drug Ad- ministration, 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]
370
VerDate 06
§ 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:
Substances Limitations
Bis(p-ethylbenzylidene) sorbitol (CAS Reg. No. 79072±96±1) ... For use only as a clarifying agent at a level not to exceed 0.3 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 or 3.2 contain not less than 85-weight percent of polymer units derived from propylene, in contact with all food types except alcoholic beverages containing more than 20 percent by weight of al- cohol; under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. Di(p-tolylidene) sorbitol (CAS Reg. No. 54686±97±4) ...... For use only as a clarifying agent at a level not to exceed 0.32 percent by weight in propylene homopolymer complying with § 177.1520(c) of this chapter, item 1.1, and in olefin 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. 32647±67±9) formed by For use only as a clarifying agent for olefin polymers com- the condensation of two moles of benzaldehyde with one plying with § 177.1520(c) 1.1, 3.1, and 3.2 of this chapter mole of sorbitol, such that the final product has a minimum under conditions of use C, D, E, F, and G, described in table content of 95 percent dibenzylidene sorbitol. 2 of § 176.170(c) of this chapter at a level not exceeding 0.25 percent by weight of the polymer.
371
VerDate 06
Substances Limitations
Dimethyldibenzylidene sorbitol (CAS Reg. No. 135861±56±2) For use only as a clarifying agent at a level not to exceed 0.4 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 3.1, and 3.2, where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from polypropylene. The finished polymers shall be used in 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. 25498±06±0) ...... For use only as a clarfiying agent for polypropylene complying with § 177.1520(c) of this chapter, item 1.1., and in 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. 10491± For use only as a clarifying agent at a level not exceeding 0.35 31±3). parts per hundred of the resin in olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2 (where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units de- rived from propylene). Sodium 2,2′-methylenebis(4,6-di-tert-butylphenyl)phosphate For use only: (CAS Reg. No. 85209±91±2).. 1. As a clarifying agent at a level not exceeding 0.30 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2 (where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from polypropylene). The finished polymers contact foods only of types I, II, IV-B, VI-B, VII-B, and VIII as identified in table 1 of § 176.170(c) of this chapter and limited to conditions of use B through H, 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, IV±B, VI±A, VI±B, and VII±B 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, IV±A, V, VI±C, and VII±A as identified in Table 1 of § 176.170(c) of this chapter and limited to conditions of use C through G 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]
§ 178.3297 Colorants for polymers. (a) The term colorant means a dye, pigment, or other substance that is The substances listed in paragraph used to impart color to or to alter the (e) of this section may be safely used as color of a food-contact material, but colorants in the manufacture of arti- that does not migrate to food in cles or components of articles intended amounts that will contribute to that for use in producing, manufacturing, food any color apparent to the naked packing, processing, preparing, treat- eye. For the purpose of this section, ing, packaging, transporting, or hold- the term ‘‘colorant’’ includes sub- ing food, subject to the provisions and stances such as optical brighteners and definitions set forth in this section: fluorescent whiteners, which may not
372
VerDate 06
themselves be colored, but whose use is prescribed by that regulation. Extrac- intended to affect the color of a food- tion testing guidelines to conduct stud- contact material. ies for additional uses of colorants (b) The colorant must be used in ac- under this section are available from cordance with current good manufac- the Food and Drug Administration free turing practice, including use levels of charge from the Center for Food which are not in excess of those reason- Safety and Applied Nutrition, (HFS– ably required to accomplish the in- 200) Food and Drug Administration, 200 tended coloring effect. C St. SW., Washington, DC 20204. (c) Colorants in this section must (d) Color additives and their lakes conform to the description and speci- fications indicated. If a polymer de- listed for direct use in foods, under the scribed in this section is itself the sub- provisions of the color additive regula- ject of a regulation promulgated under tions in parts 73, 74, 81, and 82 of this section 409 of the Federal Food, Drug, chapter, may also be used as colorants and Cosmetic Act, it shall also comply for food-contact polymers. with any specifications and limitations (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. 59487±23±9). § 176.170(c) of this chapter. N-[4-(Aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H- For use at levels not to exceed 1 percent by weight of poly- benzimidazol-5-yl)amino]carbonyl]-2- mers. The finished articles are to contact food only under oxopropyl]azo]benzamide (C. I. Pigment Yellow 181, CAS conditions of use B through H described in table 2 of Reg. No. 74441±05±7). § 176.170(c) of this chapter. Barium sulfate. Bentonite. Bentonite, modified with 3-dimethyldioctadecylammonium ion. 1,4-Bis[(2,4,6-trimethylphenyl)amino]-9,10-anthracenedione For use at levels not to exceed 0.0004 percent by weight of (CAS Reg. No. 116±75±6). polyethylene phthalate polymers complying with § 177.1630 of this chapter. 3,6-Bis(4-chlorophenyl)-2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4- For use only at levels not to exceed 1 percent by weight of dione (C.I. Pigment Red 254, CAS Reg. No. 84632±65±5). polymers. The finished articles are to contact food only under conditions of use B through H, described in table 2 of § 176.170(c) of this chapter. 4,4′-Bis(4-anilino-6-diethanolamine-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. 129423±54±7). only under conditions of use B through H as described in table 2 of § 176.170(c) of this chapter. 4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-pyrazol-4- For use at levels not to exceed 0.5 percent by weight of poly- yl]azo]-5-methylbenzenesulfonic acid, diammonium salt (1:2): mers. The finished articles are to contact food under condi- (C.I. Pigment Yellow 191:1, CAS Reg. No. 154946±66±4). tions of use A through H described in Table 2 of § 176.170(c) of this chapter.
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.
373
VerDate 06
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. 68186±91±4).. mers. The finished articles are to contact food only under conditions of use A through H as described in table 2 of § 176.170(c) of this chapter. D&C Red No. 7 and its lakes. Diatomaceous earth. 4,4′-Diamino-[1,1′-bianthracene]-9,9′,10,10′-tetrone (CAS Reg. For use at levels not to exceed 1 percent by weight of poly- No. 4051±63±2). mers. The finished articles are to contact food only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2,9-Dichloro-5,12-dihydroquinone[2,3-b]acridine-7,14-dione (C.I. For use at levels not to exceed 1.0 percent by weight of poly- Pigment Red 202, CAS Reg. No. 3089±17±6). mers. 5-[(2,3-Dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]- For use at levels not to exceed 1 percent by weight of poly- 2,4,6(1H, 3H, 5H)-pyrimidinetrione (CAS Reg. No. 72102± mers. The finished articles are to contact food only under 84±2). conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2,9-Dimethylanthra(2,1,9-def:6,5,10-d′e′f′)diisoquinoline- For use at levels not to exceed 1 percent by weight of poly- 1,3,8,10(2H,9H)-tetrone (C.I. Pigment Red 179, CAS Reg. mers. The finished articles are to contact food only under No. 5521±31±3).. conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter. 3,3′-[(2,5-Dimethyl-1,4-phenylene)bis[imino(1-acetyl-2-oxo-2,1- For use at levels not to exceed 1 percent by weight of poly- ethanediyl)azo]]bis[4-chloro-N-(5-chloro-2-methylphenyl)- mers. The finished articles are to contact food only under benzamide] (CAS Reg. No. 5280±80±8). conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 3,3′-[(2,5-Dimethyl-1,4-phenylene)bis[imino-carbonyl(2-hydroxy- For use at levels not to exceed 1 percent by weight of poly- 3,1-naphthalenediyl) azo]] bis(4-methylbenzoic acid), bis(2- mers. The finished articles are to contact food only under chloroethyl) ester (CAS Reg. No. 68259±05±2).. conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2,2′-[1,2-Ethanediylbis(oxy-2,1-phenyleneazo)]bis[N-(2,3- For use at levels not to exceed 1.0 percent by weight of poly- dihydro-2-oxo-1H-benzimidazol-5-yl)]-3-oxo-butanamide (C.I. mers. The finished articles are to contact food only under Pigment Yellow 180, CAS Reg. No. 77804±81±0). conditions of use B through G described in table 2 of § 176.170(c) of this chapter. 2,2′-(1,2-Ethenediyldi-4,1-phenylene) bis(benzoxazole) (CAS For use as an optical brightener for all polymers at a level not Reg. No. 1533±45±5). to exceed 0.025 percent by weight of polymer. The finished polymer shall contact foods only of the types identified in table 1 of § 176.170(c) of this chapter, under categories I, II, IV±B, VI±A, VI±B, VII±B, and VIII at temperatures not to ex- ceed 275 °F. High-purity furnace black (CAS Reg. No. 1333±86±4) con- For use at levels not to exceed 2.5 percent by weight of the taining total polynuclear aromatic hydrocarbons not to ex- polymer. ceed 0.5 parts per million, and benzo[a]pyrene not to exceed 5.0 parts per billion, as determined by a method entitled ``Determination of PAH Content of Carbon Black,'' dated July 8, 1994, as developed by the Cabot Corp., which is 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 (HFS±200), 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.
374
VerDate 06
Substances Limitations
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). Mixed methylated 4,4′-bis(2-benzoxazolyl)stilbenes with the For use as an optical brightener only at levels not to exceed major portion consisting of 4-(2-benzoxazolyl)-4′-(5-methyl-2- 0.05 percent by weight of rigid and semirigid polyvinyl chlo- benzoxazolyl)stilbene (CAS Registry No. 5242±49±9) and ride and not to exceed 0.03 percent by weight in all other lesser portions consisting of 4,4′-bis(5-methyl-2- polymers. The finished food-contact articles shall be used benzoxazolyl)stilbene (CAS Registry No. 2397±00±4) and only under conditions of use D, E, F, and G described in 4,4′-bis(2-benzoxazolyl)stilbene (CAS Registry No. 1533±45± table 2 of § 176.170(c) of this chapter. 5). 7-(2H-Naphtho[1,2-d]triazol-2-yl)-3-phenylcoumarin (CAS Reg. For use as an optical brightener only in: No. 3333±62±8) having a melting point of 250 °C to 251 °C 1. Olefin polymers complying with § 177.1520 of this chapter and a nitrogen content of 10.7 to 11.2 percent. only at levels such that the product of concentration of the optical brightener (expressed in parts per million by weight of the olefin polymer) multiplied by the thickness of the olefin polymer (expressed in thousandths of an inch and limited to no more than 0.400 inch) shall not exceed 500; provided that the level of the brightener shall not exceed 20 parts per million by weight of the olefin polymer, and further that the olefin polymers shall comply with specifications for items 1.1, 2.1, 3.1, 3.3, and 4 of § 177.1520(c) of this chapter. The polymer may be used under the conditions described in § 176.170(c) of this chapter, table 2, under conditions of use E, F, and G. 2. Polyethylene terephthalate specified in § 177.2800(d)(5)(i) of this chapter at a level not to exceed 0.035 percent by weight of the finished fibers. 1,1′-[(6-Phenyl-1,3,5-triazine-2,4-diyl)diimino]bis-9,10- For use at levels not to exceed 0.25 percent by weight of poly- anthracenedione (CAS Reg. No. 4118±16±5). ethylene phthalate polymers that comply with § 177.1630 of this chapter. The finished articles are to contact food only under conditions of use E, F, and G described in table 2, § 176.170(c) of this chapter, except, when such articles are used with food types III, IV±A, and V, described in table 1, § 176.170(c) of this chapter, the finished articles are to 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. 147±14±8). Phthalocyanine green (C.I. pigment green 7, C.I. No. 74260). C.I. Pigment red 38 (C.I. No. 21120) ...... For use only in rubber articles for repeated use complying with § 177.2600 of this chapter; total use is not to exceed 10 per- cent by weight of rubber article. Quinacridone red (C.I. Pigment violet 19, C.I. No. 73900). Sienna (raw and burnt). Silica. 2,3,4,5-Tetrachloro-6-cyanobenzoic acid, methyl ester reaction For use only at levels not to exceed 1 percent by weight of products with p-phenyllenediamine and sodium methoxide polymers. The finished articles are to contact food only (CAS reg. No. 106276±80±6). under conditins of use B through H, described in table 2, of § 176.170(c) of this chapter. 4,5,6,7-Tetrachloro-2-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3- For use only at levels not to exceed 1 percent by weight of dioxo-1H-inden-2-yl)-8-quinolinyl]-1H-isoindole-1,3(2H)-dione polymers. The finished articles are to contact food only (C. I. Pigment Yellow 138, CAS Reg. No.30125±47±4).. under conditions of use C through H, as described in table 2 of § 176.170(c) of this chapter; provided further that the 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. 7128±64±5).. 1. In all polymers at levels not to exceed 0.015 percent by weight of the polymer. The finished articles are to contact food only under conditions of use A through H described in table 2 of § 176.170(c) of this chapter. 2. In all polymers at levels not to exceed 0.05 percent by weight of the polymer. The finished articles shall contact foods only of the types identified in table 1 of § 176.170(c) of this chapter, under Categories I, II, IV±B, VI±A, VI±B, VI±C, VII±B, and VIII under conditions of use A through H 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.
375
VerDate 06
Substances Limitations
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] List of substances Limitations
EDITORIAL NOTE: For FEDERAL REGISTER ci- Dicyclohexylamine and its salts of tations affecting § 178.3297, see the List of fatty acids derived from animal CFR Sections Affected in the Finding Aids or vegetable oil. section of this volume. Dicyclohexylamine nitrite. Morpholine and its salts of fatty § 178.3300 Corrosion inhibitors used acids derived from animal or for steel or tinplate. vegetable oils. Corrosion inhibitors may be safely (2) Adjuvants employed in the appli- used for steel or tinplate intended for cation and use of corrosion inhibitors: use in, or to be fabricated as, food con- tainers or food-processing or handling List of substances Limitations equipment, subject to the provisions of Propylene glycol. this section. (a) The corrosion inhibitors are pre- § 178.3400 Emulsifiers and/or surface- pared from substances identified in this active agents. section and used subject to the limita- tions prescribed. The substances listed in paragraph (c) of this section may be safely used as (b) The following corrosion inhibitors emulsifiers and/or surface-active or adjuvants are used in amounts not agents in the manufacture of articles to exceed those reasonably required to or components of articles intended for accomplish the intended physical or use in producing, manufacturing, pack- technical effect: ing, processing, preparing, treating, (1) Corrosion inhibitors (active ingre- packaging, transporting, or holding dients) used in packaging materials for food, subject to the provisions of this the packaging of steel or tinplate or ar- section. ticles fabricated therefrom: (a) The quantity used shall not ex- ceed the amount reasonably required to accomplish the intended technical
376
VerDate 06
effect; and the quantity that may be- or article that is the subject of a regu- come a component of food as a result of lation in parts 174, 175, 176, 177, 178 and such use shall not be intended to, nor § 179.45 of this chapter conforms with in fact, accomplish any physical or any specifications and limitations pre- technical effect in the food itself. scribed by such regulation for the fin- (b) The use as an emulsifier and/or ished form of the substance or article. surface-active agent in any substance (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 C10±C18 with not less than 50 per- 1. As provided in § 176.170 of this chapter. cent C14±C16).. 2. At levels not to exceed 2 percent by weight of polyvinyl chloride and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. 3. As emulsifiers in vinylidene chloride copolymer or homopolymer coatings at levels not to exceed a total of 2.6 percent by weight of coating solids. The finished polymer contacts food only of the Types I, II, III, IV, V, VIA, VIB, VII, VIII, and IX as identified in table 1 of § 176.170(c) of this chapter, and limited to conditions of use E, F, and G 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 7±20 moles of ethylene oxide. alpha Olefin sulfonate [alkyl group is in the range of C10±C18 For use only: with not less than 50 percent C14±C16], ammonium, calcium, 1. In acrylonitrile-butadiene copolymers identified in magnesium, potassium, and sodium salts. § 177.2600(c)(4)(i) of this chapter. 2. At levels not to exceed 1 percent by weight of acrylic 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. 30174±67±5). cent by weight of styrene-butadiene copolymer coatings for paper and paperboard complying with § 176.170 of this chapter.
377
VerDate 06
List of substances Limitations
Ammonium salt of epoxidized oleic acid, produced from For use only: epoxidized oleic acid (predominantly dihydroxystearic and 1. As a polymerization emulsifier at levels not to exceed 1.5 acetoxyhydroxystearic acids) meeting the following specifica- pct by weight of vinyl chloride polymers used as components tions: Acid number 160±180, saponification number 210± of nonfood articles complying with §§ 175.105, 175.300, 235, iodine number 2±15, and epoxy groups 0±0.4 percent. 176.170, 176.180, and 177.1210 of this chapter. Such vinyl chloride polymers are limited to polyvinyl chloride and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. 2. As a polymerization emulsifier at levels not to exceed 1.5 pct by weight of vinyl chloride-vinyl acetate copolymers used as components of nonfood articles complying with §§ 175.105, 175.300, 176.170, 176.180, and 177.1210 of this chapter. α-Di-sec-butylphenyl-omega-hydroxypoly(oxyethylene) pro- duced by the condensation of 1 mole of di-sec-butylphenol with an average of 4±14 or 30±50 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a com- ponent of the blend shall be in the range 4±14 or 30±50; sec-butyl groups are predominantly (90 percent or more) o-, p-substituents. Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294±49± For use only as an emulsifier at levels not to exceed 5 percent 8).. by weight of polymers intended for use in coatings. α-Dodecyl-omega-hydroxpoly (oxyethylene) mixture of dihydro- gen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 103±111 and that are produced by the esterification of the condensation product of 1 mole of n-dodecyl alcohol with 4±4.5 moles of ethylene oxide. 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 4±14 or 30±50 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4±14 or 30±50. α-(p-nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 49±59 and that are produced by the esterification of a-(p-nonylphenyl)-omega- hydroxypoly (oxyethylene) complying with the identity pre- scribed in § 178.3400(c) and having an average poly(oxyethylene) content of 5.5±6.5 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 62±72 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 9±10 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 98±110 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 45±55 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 4±14 or 30± 50 moles of ethylene oxide: if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4±14 or 30±50. 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(C10±C12) ether sulfosuccinate, diso- For use only at levels not to exceed 5 percent by weight of dium salt (CAS Reg. No. 68954±91±6).. 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.
378
VerDate 06
List of substances Limitations
Poly[(methylene-p-nonylphenoxy) poly(oxypropylene)(4±12 For use in coatings at levels not to exceed 1 mg per square moles) propanol] of minimum molecular weight 3500. foot of food-contact surface. Poly(oxypropylene) (45±48 moles) block polymer with For use only as a surface-active agent at levels not to exceed poly(oxyethylene). The finished block polymers meet the fol- 0.5 percent by weight of polyolefin film or polyolefin coatings. lowing specifications: Average molecular weight 11,000± Such polyolefin film and polyolefin coatings shall have an av- 18,000; hydroxyl number 6.2±10.2; ´cloud point above 100 erage thickness not to exceed 0.005 inch and shall be lim- °C. for 10 pct solution. ited to use in contact with foods that have a pH above 5.0 and that contain no more than 8 pct of alcohol. Polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate) meeting the following specifications: Saponification number 40±50, acid number 0±2, hydroxyl number 60±108, oxy- ethylene content 70±74 pct. Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate) meeting the following specifications: Saponification number 41±52, oxyethylene content 66±70.5 pct. Polysorbate 60 conforming to the identity prescribed in § 172.836 of this chapter. Polysorbate 65 conforming to the identity prescribed in § 172.838 of this chapter. Polysorbate 80 conforming to the identity prescribed in § 172.840 of this chapter. Polysorbate 85 (polyoxyethylene (20) sorbitan trioleate) meet- ing the following specifications: Saponification number 80± 95, oxyethylene content 46±50 percent. Sodium 1,4-dicylcohexyl sulfosuccinate. Sodium 1,4-dihexyl sulfosuccinate. Sodium 1,4 diisobutyl sulfosuccinate. Sodium dioctyl sulfosuccinate. Sodium 1,4-dipentyl sulfosuccinate. Sodium 1,4-ditridecyl sulfosuccinate. Sodium lauryl sulfate. Sodium monoalkylphenoxybenzenedisulfonate and sodium dialkylphenoxybenzenedisulfonate mixtures containing not less than 70 pct of the monoalkylated product where the alkyl group is C8–C16. Sorbitan monolaurate meeting the following specifications. Sa- ponification number 153±170; and hydroxyl number 330±360. Sorbitan monooleate meeting the following specifications: Sa- ponification number 145±160, hydroxyl number 193±210. Sorbitan monopalmitate meeting the following specifications: Saponification No. 140±150; and hydroxyl No. 275±305. Sorbitan monostearate conforming to the identity prescribed in § 172.842 of this chapter. Sorbitan trioleate meeting the following specifications: Saponi- fication No. 170±190; and hydroxyl No. 55±70. Sorbitan tristearate meeting the following specifications: Sa- ponification No. 176±188; and hydroxyl No. 66±80. Sulfosuccinic acid 4-ester with polyethylene glycol dodecyl For use only at levels not to exceed 5 percent by weight of ether, disodium salt (CAS Reg. No. 39354±45±5). total monomers used in the emulsion polymerization of 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 9±10 moles of of polyvinyl acetate and vinyl-acrylate copolymers intended ethylene oxide) (CAS Reg. No. 9040±38±4). for use as coatings for paper and paperboard. 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 4±14 or 30±40 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 4±14 or 30±50. Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecyl-sulfosuccinate For use only as a polymerization emulsifier for resins applied to tea-bag material. α-Tridecyl-omega-hydroxypoly (oxyethylene) mixture of di- hydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 75±85 and that are produced by the esterification of the condensation product of one mole of ``oxo'' process tridecyl alcohol with 5.5±6.5 moles of ethylene oxide.
379
VerDate 06
List of substances Limitations
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 58±70 and that are produced by the esterification of the condensation product of one mole of ``oxo'' process tridecyl alcohol with 9±10 moles of ethylene oxide.
(d) The provisions of this section are (1) As substitutes for the cor- not applicable to emulsifiers and/or responding naturally derived fatty al- surface-active agents listed in cohols permitted for use as components § 175.105(c)(5) of this chapter and used in of articles intended for use in contact food-packaging adhesives complying with food by existing regulations in with § 175.105 of this chapter. parts 174, 175, 176, 177, 178 and § 179.45 of [42 FR 14609, Mar. 15, 1977, as amended at 43 this chapter: Provided, That the use is FR 58557, Dec. 15, 1978; 44 FR 42679, July 20, in compliance with any prescribed lim- 1979; 45 FR 67321, Oct. 10, 1980; 48 FR 24870, itations. June 3, 1983; 49 FR 5748, Feb. 15, 1984; 51 FR (2) As substitutes for the cor- 31763, Sept. 5, 1986; 56 FR 41457, Aug. 21, 1991; responding naturally derived fatty al- 58 FR 26687, May 5, 1993; 60 FR 18351, Apr. 11, 1995; 61 FR 14246, Apr. 1, 1996; 62 FR 33997, cohols used as intermediates in the June 24, 1997; 62 FR 42051, Aug. 5, 1997; 63 FR synthesis of food additives and other 29551, June 1, 1998] substances permitted for use as compo- nents of food-contact articles. § 178.3450 Esters of stearic and pal- (c) Synthetic fatty alcohols identi- mitic acids. fied in paragraph (c)(1) of this section The ester stearyl palmitate or may contain not more than 0.8 weight palmityl stearate or mixtures thereof percent of total diols as determined by may be safely used as adjuvants in a method titled ‘‘Diols in Monohydroxy food-packaging materials when used in Alcohol by Miniature Thin Layer Chro- accordance with the following pre- matography (MTLC),’’ which is incor- scribed conditions: porated by reference. Copies are avail- (a) They are used or intended for use able from the Center for Food Safety as plasticizers or lubricants in poly- and Applied Nutrition (HFS–200), Food styrene intended for use in contact and Drug Administration, 200 C St. with food. SW., Washington, DC 20204, or available (b) They are added to the formulated for inspection at the Office of the Fed- polymer prior to extrusion. (c) The quantity used shall not ex- eral Register, 800 North Capitol Street, ceed that required to accomplish the NW., suite 700, Washington, DC 20408. intended technical effect. (1) Synthetic fatty alcohols. (i) Hexyl, octyl, decyl, lauryl, myristyl, cetyl, § 178.3480 Fatty alcohols, synthetic. and stearyl alcohols meeting the speci- Synthetic fatty alcohols may be safe- fications and definition prescribed in ly used as components of articles in- § 172.864 of this chapter, except that tended for use in contact with food, they may contain not more than 0.8 and in synthesizing food additives and weight percent total diols. other substances permitted for use as (ii) Lauryl, myristyl, cetyl, and ste- components of articles intended for use aryl alcohols manufactured by the in contact with food in accordance process described in § 172.864(a)(2) of with the following prescribed condi- this chapter such that lauryl and tions: myristyl alcohols meet the specifica- (a) The food additive consists of fatty tions in § 172.864(a)(1)(i) of this chapter, alcohols meeting the specifications and and cetyl and stearyl alcohols meet the definition prescribed in § 172.864 of this specifications in § 172.864(a)(1)(ii) of this chapter, except as provided in para- chapter. graph (c) of this section. (2) Conditions of use. (i) Synthetic (b) It is used or intended for use as fatty alcohols as substitutes for the follows: corresponding naturally derived fatty
380
VerDate 06
alcohols permitted for use in compli- tended for use in producing, manufac- ance with § 178.3910. turing, packing, processing, preparing, (ii) Synthetic lauryl alcohol as a sub- treating, packaging, transporting, or stitute for the naturally derived lauryl holding food, subject to the provisions alcohol permitted as an intermediate of this section. in the synthesis of sodium lauryl sul- (a) The additive is applied to the sur- fate used in compliance with § 178.3400. face of calcium carbonate at a level not to exceed 1 weight-percent of the total [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, mixture. 1989] (b) The calcium carbonate/glyceryl tri-(12-acetoxystearate) mixture is used § 178.3500 Glycerin, synthetic. as an adjuvant in polymers in contact with nonfatty foods at a level not to Synthetic glycerin may be safely exceed 20 weight-percent of the poly- used as a component of articles in- mer. tended for use in packaging materials for food, subject to the provisions of [50 FR 1503, Jan. 11, 1985] this section: (a) It is produced by the hydro- § 178.3520 Industrial starch-modified. genolysis of carbohydrates, and shall Industrial starch-modified may be contain not in excess of 0.2 percent by safely used as a component of articles weight of a mixture of butanetriols. intended for use in producing, manu- (b) It is used in a quantity not to ex- facturing, packing, processing, pre- ceed that amount reasonably required paring, treating, packaging, trans- to produce its intended physical or porting, or holding food, subject to the technical effect, and in accordance provisions of this section. with any limitations prescribed by ap- (a) Industrial starch-modified is iden- plicable regulations in parts 174, 175, tified as follows: 176, 177, 178 and 179 of this chapter. It (1) A food starch-modified or starch shall not be intended to, nor in fact ac- or any combination thereof that has complish, any direct physical or tech- been modified by treatment with one of nical effect in the food itself. the reactants hereinafter specified, in an amount reasonably required to § 178.3505 Glyceryl tri-(12-acetoxy- achieve the desired functional effect stearate). but in no event in excess of any limita- Glyceryl tri-(12-acetoxystearate) tion prescribed, with or without subse- (CAS Reg. No. 139–43–5) may be safely quent treatment as authorized in used as a component of articles in- § 172.892 of this chapter.
List of reactants Limitations
Ammonium persulfate, not to exceed 0.3 pct. or in alkaline starch not to exceed 0.6 pct.. (4-Chlorobutene-2) trimethylammonium chloride, not to exceed Industrial starch modified by this treatment shall be used only 5 pct. as internal sizing for paper and paperboard intended for food packaging. 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.
381
VerDate 06
(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 Boiling point 63° –260 °C, as determined by used as surface-active agents in the ASTM method D86–82, ‘‘Standard Method processing of industrial starch-modi- for Distillation of Petroleum Products,’’ fied: which is incorporated by reference. Copies may be obtained from the American Soci- Polyethylene glycol (400) dilaurate. ety for Testing Materials, 1916 Race St., Polyethylene glycol (400) monolaurate. Philadelphia, PA 19103, or may be exam- Polyoxyethylene (4) lauryl ether. ined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, (c) To insure safe use of the indus- Washington, DC 20408. trial starch-modified, the label of the Ultraviolet absorbance: food additive container shall bear the 260–319 millimicrons—1.5 maximum. name of the additive ‘‘industrial 320–329 millimicrons—0.08 maximum. starch-modified,’’ and in the instance 330–350 millimicrons—0.05 maximum. of an industrial starch-modified which Nonvolatile residue 0.002 gram per 100 milli- is limited with respect to conditions of liters maximum. use, the label of the food additive con- Synthetic isoparaffinic petroleum hydro- tainer shall contain a statement of carbons containing antioxidants shall meet such limited use. the specified ultraviolet absorbance limits after correction for any absorbance due to [42 FR 14609, Mar. 15, 1977, as amended at 42 the antioxidants. The ultraviolet absorbance FR 49453, Sept. 27, 1977] shall be determined by the procedure de- scribed for application to mineral oil under § 178.3530 Isoparaffinic petroleum hy- ‘‘Specifications’’ on page 66 of the ‘‘Journal drocarbons, synthetic. of the Association of Official Agricultural Chemists,’’ Vol. 45 (February 1962), which is Isoparaffinic petroleum hydro- incorporated by reference, disregarding the carbons, synthetic, may be safely used last sentence of that procedure. For hydro- in the production of nonfood articles carbons boiling below 121 °C, the nonvolatile intended for use in producing, manu- residue shall be determined by ASTM meth- facturing, packing, processing, pre- od D1353–78, ‘‘Standard Test Method for Non- paring, treating, packaging, trans- volatile Matter in Volatile Solvents for Use porting, or holding food, subject to the in Paint, Varnish, Lacquer, and Related ° provisions of this section. Products;’’ for those boiling above 121 C, ASTM procedure D381–80, ‘‘Standard Test (a) The isoparaffinic petroleum hy- Method for Existent Gum in Fuels by Jet drocarbons, produced by synthesis from Evaporation,’’ which are incorporated by ref- petroleum gases consist of a mixture of erence. Copies may be obtained from the liquid hydrocarbons meeting the fol- American Society for Testing Materials, 1916 lowing specifications: Race St., Philadelphia, PA 19103, or may be
382
VerDate 06
examined at the Office of the Federal Reg- § 178.3570 Lubricants with incidental ister, 800 North Capitol Street, NW., suite food contact. 700, Washington, DC 20408. Lubricants with incidental food con- (b) Isoparaffinic petroleum hydro- tact may be safely used on machinery carbons may contain antioxidants au- used for producing, manufacturing, thorized for use in food in an amount not to exceed that reasonably required packing, processing, preparing, treat- to accomplish the intended technical ing, packaging, transporting, or hold- effect. ing food, subject to the provisions of (c) Isoparaffinic petroleum hydro- this section: carbons are used in the production of (a) The lubricants are prepared from nonfood articles. The quantity used one or more of the following sub- shall not exceed the amount reason- stances: ably required to accomplish the in- (1) Substances generally recognized tended technical effect, and the resid- as safe for use in food. ual remaining in the finished article (2) Substances used in accordance shall be the minimum amount reason- with the provisions of a prior sanction ably attainable. or approval. [42 FR 14609, Mar. 15, 1977, as amended at 47 (3) Substances identified in this para- FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, graph (a)(3). 1984]
Substances Limitations
Aluminum stearoyl benzoyl hydroxide ...... For use only as a thickening agent in mineral oil lubricants at a level not to exceed 10 pct by weight of the mineral oil. N,N-Bis(2-ethylhexyl)-ar-methyl-1H-benzotriazole-1- For use as a copper deactivator at a level not to exceed 0.1 methanamine (CAS Reg. No. 94270±86±7).. percent by weight of the lubricant. BHA. BHT. 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. 9038±95±3. α-Butyl-omega-hydroxypoly(oxypropylene); minimum molecular Do. weight 1,500; Chemical Abstracts Service Registry No. 9003±13±8. Castor oil ...... Do. Castor oil, dehydrated ...... Do. Castor oil, partially dehydrated ...... Do. Dialkyldimethylammonium aluminum silicate (CAS Reg. No. For use only as a gelling agent in mineral oil lubricants at a 68953±58±2), which may contain up to 7 percent by weight level not to exceed 15 percent by weight of the mineral oil. 1,6-hexanediol (CAS Reg. No. 629±11±8), where the alkyl groups are derived from hydrogenated tallow fatty acids (C14±C18) and where the aluminum silicate is derived from bentonite. Dimethylpolysiloxane (viscosity greater than 300 centistokes) ... Addition to food not to exceed 1 part per million. Disodium decanedioate (CAS Reg. No. 17265±14±4) ...... For use only: 1. As a corrosion inhibitor or rust preventative in mineral oil- bentonite lubricants at a level not to exceed 2 percent by weight of the grease. 2. As a corrosion inhibitor or rust preventative only in greases at a level not to exceed 2 percent by weight of the grease. Disodium EDTA (CAS Reg. No. 139±33±3) ...... For use only as a chelating agent and sequestrant at a level not to exceed 0.06 percent by weight of lubricant at final use dilution. Ethoxylated resin phosphate ester mixture consisting of the fol- For use only as a surfactant to improve lubricity in lubricating lowing compounds: fluids complying with this section at a level not to exceed 5 percent by weight of the lubricating fluid. 1. Poly(methylene-p-tert-butyl- phenoxy)poly-(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters (0 to 40 percent of the mixture). The resin is formed by condensation of 1 mole of p-tert- butylphenol with 2 to 4 moles of formaldehyde and sub- sequent ethoxylation with 4 to 12 moles of ethylene oxide;.
383
VerDate 06
Substances Limitations
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. 56831±62±0). Fatty acids derived from animal or vegetable sources, and the hydrogenated forms of such fatty acids. 2-(8-Heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol (CAS For use at levels not to exceed 0.5 percent by weight of the lu- Reg. No. 95±38±5). bricant. Hexamethylenebis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate) For use as an antioxidant at levels not to exceed 0.5 percent (CAS Reg. No. 35074±77±2). by weight of the lubricant. 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. 9003±11±6. 12-Hydroxystearic acid. Isopropyl oleate ...... For use only as an adjuvant (to improve lubricity) in mineral oil lubricants. Magnesium ricinoleate ...... For use only as an adjuvant in mineral oil lubricants at a level not to exceed 10 percent by weight of the mineral oil. Mineral oil ...... Addition to food not to exceed 10 parts per million. N-Methyl-N-(1-oxo-9- octadecenyl)glycine (CAS Reg. No. 110± For use as a corrosion inhibitor at levels not to exceed 0.5 per- 25±8). cent by weight of the lubricant. N-phenylbenzenamine, reaction products with 2,4,4- For use only as an antioxidant at levels not to exceed 0.5 per- trimethylpentene (CAS Reg. No. 68411±46±1). cent by weight of the lubricant. Petrolatum ...... Complying with § 178.3700. Addition to food not to exceed 10 parts per million. Phenyl-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 (C12±C14) primary amines (CAS Reg. No. 68187± inlubricants at a level not to exceed 0.5 percent by weight of 67±7). the lubricant. Polyurea, having a nitrogen content of 9±14 percent based on For use only as an adjuvant in mineral oil lubricants at a level the dry polyurea weight, produced by reacting tolylene not to exceed 10 percent by weight of the mineral oil. diisocyanate with tall oil fatty acid (C16 and C18) amine and ethylene diamine in a 2:2:1 molar ratio. Polybutene (minimum average molecular weight 80,000) ...... Addition to food not to exceed 10 parts per million. Polybutene, hydrogenated; complying with the identity pre- Do. scribed under § 178.3740. Polyethylene ...... Do. Polyisobutylene (average molecular weight 35,000±140,000 For use only as a thickening agent in mineral oil lubricants. (Flory)). Sodium nitrite ...... For use only as a rust preventive in mineral oil lubricants at a level not to exceed 3 percent by weight of the mineral oil. Tetrakis[methylene(3,5-di-tert-butyl-4-hydroxyhydro- For use only as an antioxidant in lubricants at a level not to ex- cinnamate)]methane (CAS Reg. No. 6683±19±8). ceed 0.5 percent by weight of the lubricant. Thiodiethylenebis (3,5-di-tert-butyl-4-hydroxyhydrocinnamate) For use as an antioxidant at levels not to exceed 0.5 percent (CAS Reg. No. 41484-35-9). by weight of the lubricant. Tri[2(or 4)-C9-10-branched alkylphenyl]phosphorothioate (CAS For use only as an extreme pressure-antiwear adjuvant at lev- Reg. No. 126019±82±7).. els not to exceed 0.5 percent by weight of the lubricant. Triphenyl phosphorothionate (CAS Reg. No. 597±82±0) ...... For use as an adjuvant in lubricants herein listed at a level not to exceed 0.5 percent by weight of the lubricant. Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. NO. 31570± For use only as a stabilizer at levels not to exceed 0.5 percent 04±4). by weight of the lubricant. Thiodiethylenebis(3,5-di-tert-butyl-4-hydroxy-hydro- cinnamate) For use as an antioxidant at levels not to exceed 0.5 percent (CAS Reg. No. 41484±35±9). by weight of the lubricant. Zinc sulfide ...... For use at levels not to exceed 10 percent by weight of the lu- bricant.
(b) The lubricants are used on food- kets or seals of tank closures, and as a processing equipment as a protective antirust film, as a release agent on gas-
384
VerDate 06
lubricant for machine parts and equip- North Capitol Street, NW., suite 700, ment in locations in which there is ex- Washington, DC 20408. posure of the lubricated part to food. (b) The polyolefin film is produced The amount used is the minimum re- from olefin polymers complying with quired to accomplish the desired tech- § 177.1520 of this chapter, and the aver- nical effect on the equipment, and the age thickness of the film in the form in addition to food of any constituent which it contacts food does not exceed identified in this section does not ex- 0.002 inch. ceed the limitations prescribed. (c) Any substance employed in the [42 FR 14609, Mar. 15, 1977, as amended at 47 production of the lubricants described FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, in this section that is the subject of a 1989] regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms § 178.3620 Mineral oil. with any specification in such regula- Mineral oil may be safely used as a tion. component of nonfood articles intended for use in contact with food, subject to [42 FR 14609, Mar. 15, 1977] the provisions of this section: EDITORIAL NOTE: For FEDERAL REGISTER ci- (a) White mineral oil meeting the tations affecting § 178.3570, see the List of specifications prescribed in § 172.878 of CFR Sections Affected in the Finding Aids section of this volume. this chapter may be used as a compo- nent of nonfood articles provided such § 178.3600 Methyl glucoside-coconut oil use complies with any applicable limi- ester. tations in parts 170 through 189 of this Methyl glucoside-coconut oil ester chapter. The use of white mineral oil in identified in § 172.816(a) of this chapter or on food itself, including the use of may be safely used as a processing aid white mineral oil as a protective coat- (filter aid) in the manufacture of ing or release agent for food, is subject starch, including industrial starch- to the provisions of § 172.878 of this modified complying with § 178.3520, in- chapter. tended for use as a component of arti- (b) Technical white mineral oil iden- cles that contact food. tified in paragraph (b)(1) of this section may be used as provided in paragraph § 178.3610 a-Methylstyrene- (b)(2) of this section. vinyltoluene resins, hydrogenated. (1) Technical white mineral oil con- Hydrogenated α-methylstyrene- sists of specially refined distillates of vinyltoluene copolymer resins having a virgin petroleum or of specially refined molar ratio of 1 α-methylstyrene to 3 distillates that are produced syn- vinyltoluene may be safely used as thetically from petroleum gases. Tech- components of polyolefin film intended nical white mineral oil meets the fol- for use in contact with food, subject to lowing specifications: the following provisions: (i) Saybolt color 20 minimum as de- (a) Hydrogenated α-methylstyrene- termined by ASTM method D156–82, vinyltoluene copolymer resins have a ‘‘Standard Test Method for Saybolt drop-softening point of 125° to 165 °C Color of Petroleum Products (Saybolt and a maximum absorptivity of 0.17 liter per gram centimeter at 266 Chromometer Method),’’ which is in- nanometers, as determined by methods corporated by reference. Copies may be titled ‘‘Determination of Softening obtained from the American Society Point (Drop Method)’’ and ‘‘Determina- for Testing Materials, 1916 Race St., tion of Unsaturation of Resin 1977,’’ Philadelphia, PA 19103, or may be ex- which are incorporated by reference. amined at the Office of the Federal Copies are available from the Center Register, 800 North Capitol Street, for Food Safety and Applied Nutrition NW., suite 700, Washington, DC 20408. (HFS–200), Food and Drug Administra- (ii) Ultraviolet absorbance limits as tion, 200 C St. SW., Washington, DC follows: 20204, or available for inspection at the Office of the Federal Register, 800
385
VerDate 06
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 ...... 3.3 300 to 329 ...... 2.3 imum. 330 to 350 ...... 0.8 (ii) Color 5.5 maximum as determined by ASTM method D1500–82, ‘‘Standard Technical white mineral oil containing Test Method for ASTM Color of Petro- antioxidants shall meet the specified leum Products (ASTM Color Scale),’’ ultraviolet absorbance limits after cor- which is incorporated by reference. The rection for any absorbance due to the availability of this incorporation by antioxidants. The ultraviolet absorb- reference is given in paragraph (b)(1)(i) ance shall be determined by the proce- of this section. dure described for application to min- (iii) Ultraviolet absorbance limits as eral oil under ‘‘Specification’’ on page follows as determined by the analytical 66 of the ‘‘Journal of the Association of method described in paragraph (c)(3) of Official Agricultural Chemists,’’ Vol- this section: ume 45 (February 1962) (which is incor- porated by reference; copies are avail- Maximum absorb- able from the Center for Food Safety Wavelength (mµ) ance per and Applied Nutrition (HFS–200), Food centimeter optical and Drug Administration, 200 C St. pathlength SW., Washington, DC 20204, or available for inspection at the Office of the Fed- 280 to 289 ...... 0.7 290 to 299 ...... 0.6 eral Register, 800 North Capitol Street, 300 to 359 ...... 0.4 NW., suite 700, Washington, DC 20408), 360 to 400 ...... 09 disregarding the last two sentences of that procedure and substituting there- (2) The mineral oil may be used wher- for the following: Determine the ab- ever mineral oil is permitted for use as sorbance of the mineral oil extract in a a component of nonfood articles com- 10-millimeter cell in the range from plying with §§ 175.105 and 176.210 of this 260–350 mµ, inclusive, compared to the chapter and § 178.3910 (for use only in solvent control. If the absorbance so rolling of metallic foil and sheet measured exceeds 2.0 at any point in stock), §§ 176.200, 177.2260, 177.2600, and range 280–350 mµ, inclusive, dilute the 177.2800 of this chapter. extract and the solvent control, respec- (3) The analytical method for deter- tively, to twice their volume with di- mining ultraviolet absorbance limit is methyl sulfoxide and remeasure the ab- as follows: sorbance. Multiply the remeasured ab- sorbance values by 2 to determine the GENERAL INSTRUCTIONS absorbance of the mineral oil extract Because of the sensitivity of the test, the per centimeter optical pathlength. possibility of errors arising from contamina- (2) Technical white mineral oil may tion is great. It is of the greatest importance be used wherever mineral oil is per- that all glassware be scrupulously cleaned to remove all organic matter such as oil, mitted for use as a component of grease, detergent residues, etc. Examine all nonfood articles complying with glassware, including stoppers and stopcocks, §§ 175.105, 176.200, 176.210, 177.2260, under ultraviolet light to detect any residual 177.2600, and 177.2800 of this chapter and fluorescent contamination. As a pre- §§ 178.3570 and 178.3910. cautionary measure it is recommended prac- (3) Technical white mineral oil may tice to rinse all glassware with purified iso- contain any antioxidant permitted in octane immediately before use. No grease is food by regulations issued in accord- to be used on stopcocks or joints. Great care ance with section 409 of the Act, in an to avoid contamination of oil samples in handling and to assure absence of any extra- amount not greater than that required neous material arising from inadequate to produce its intended effect. packaging is essential. Because some of the (c) Mineral oil identified in para- polynuclear hydrocarbons sought in this test graph (c)(1) of this section may be used are very susceptible to photo-oxidation, the
386
VerDate 06
entire procedure is to be carried out under Wavelength accuracy, ±1.0 millimicron. subdued light. Nitrogen cylinder. Water-pumped or equiva- lent purity nitrogen in cylinder equipped APPARATUS with regulator and valve to control flow at 5 Separatory funnels. 250-milliliter, 500-milli- p.s.i.g. liter, 1,000-milliliter, and preferably 2,000- REAGENTS AND MATERIALS milliliter capacity, equipped with tetra- fluoroethylene polymer stopcocks. Organic solvents. All solvents used through- Reservoir. 500-milliliter capacity, equipped out the procedure shall meet the specifica- with a 24/40 standard taper male fitting at tions and tests described in this specifica- the bottom and a suitable ball-joint at the tion. The isooctane, benzene, acetone, and top for connecting to the nitrogen supply. methyl alcohol designated in the list fol- The male fitting should be equipped with lowing this paragraph shall pass the fol- glass hooks. lowing test: Chromatographic tube. 180 millimeters in To the specified quantity of solvent in a length, inside diameter to be 15.7 millimeters 250-milliliter Erlenmeyer flask, add 1 milli- ±0.1 millimeter, equipped with a coarse, frit- liter of purified n-hexadecane and evaporate ted-glass disc, a tetrafluoroethylene polymer on the steam bath under a stream of nitro- stopcock, and a female 24/40 standard tapered gen (a loose aluminum foil jacket around the fitting at the opposite end. (Overall length of flask will speed evaporation). Discontinue the column with the female joint is 235 milli- evaporation when not over 1 milliliter of res- meters.) The female fitting should be idue remains. (To the residue from benzene equipped with glass hooks. add a 10-milliliter portion of purified iso- Disc. Tetrafluoroethylene polymer 2-inch octane, reevaporate, and repeat once to in- diameter disk approximately 3⁄16-inch thick sure complete removal of benzene.) with a hole bored in the center to closely fit Alternatively, the evaporation time can be the stem of the chromatographic tube. reduced by using the optional evaporation Suction flask. 250-milliliter or 500-milliliter flask. In this case the solvent and n-hexa- filter flask. decane are placed in the flask on the steam Condenser. 24/40 joints, fitted with a drying bath, the tube assembly is inserted, and a tube, length optional. stream of nitrogen is fed through the inlet Evaporation flask (optional). 250-milliliter or tube while the outlet tube is connected to a 500-milliliter capacity all-glass flask solvent trap and vacuum line in such a way equipped with standard taper stopper having as to prevent any flow-back of condensate inlet and outlet tubes to permit passage of into the flask. nitrogen across the surface of contained liq- Dissolve the 1 milliliter of hexadecane res- uid to be evaporated. idue in isooctane and make to 25 milliliters Spectrophotometric cells. Fused quartz cells, volume. Determine the absorbance in the 5- optical path length in the range of 5,000 cen- centimeter path length cells compared to timeter ±0.005 centimeter; also for checking isooctane as reference. The absorbance of the spectrophotometer performance only, optical solution of the solvent residue (except for path length in the range 1,000 centimeter methyl alcohol) shall not exceed 0.01 per cen- ±0.005 centimeter. With distilled water in the timeter path length between 280 and 400 mµ. cells, determine any absorbance differences. For methyl alcohol this absorbance value Spectrophotometer. Spectral range 250 milli- shall be 0.00. microns—400 millimicrons with spectral slit Isooctane (2,2,4-trimethylpentane). Use 180 width of 2 millimicrons or less; under instru- milliliters for the test described in the pre- ment operating conditions for these absorb- ceding paragraph. Purify, if necessary, by ance measurements, the spectrophotometer passage through a column of activated silica shall also meet the following performance gel (Grade 12, Davison Chemical Company, requirements: Baltimore, Maryland, or equivalent) about 90 Absorbance repeatability, ±0.01 at 0.4 ab- centimeters in length and 5 centimeters to 8 sorbance. centimeters in diameter. Absorbance accuracy 1 ±0.05 at 0.4 absorb- Benzene, A.C.S. reagent grade. Use 150 milli- ance. liters for the test. Purify, if necessary, by distillation or otherwise. 1 As determined by procedure using potas- Acetone, A.C.S. reagent grade. Use 200 milli- sium chromate for reference standard and liters for the test. Purify, if necessary, by described in National Bureau of Standards distillation. Circular 484, Spectrophotometry, U.S. De- Eluting mixtures: partment of Commerce (1949). The accuracy is to be determined by comparison with the 200), Food and Drug Administration, 200 C St. standard values at 290, 345, and 400 milli- SW., Washington, DC 20204, or available for microns. Circular 484 is incorporated by ref- inspection at the Office of the Federal Reg- erence. Copies are available from the Center ister, 800 North Capitol Street, NW., suite for Food Safety and Applied Nutrition (HFS– 700, Washington, DC 20408.
387
VerDate 06
1. 10 percent benzene in isooctane. Pipet 50 Celite 545. Johns Mansville Company, diato- milliliters of benzene into a 250-milliliter maceous earth, or equivalent. glass-stoppered volumetric flask and adjust Magnesium oxide-Celite 545 mixture (2+1) by to volume with isooctane, with mixing. weight. Place the magnesium oxide (60–180 2. 20 percent benzene in isooctane. Pipet 50 mesh) and the Celite 545 in 2 to 1 propor- milliliters of benzene into a 250-milliliter tions, respectively, by weight in a glass- glass-stoppered volumetric flask and adjust stoppered flask large enough for adequate to volume with isooctane, with mixing. mixing. Shake vigorously for 10 minutes. 3. Acetone-benzene-water mixture. Add 20 Transfer the mixture to a glass trough lined milliliters of water to 380 milliliters of ace- with aluminum foil (free from rolling oil) tone and 200 milliliters of benzene, and mix. and spread it out on a layer about 1 centi- n-Hexadecane, 99-percent olefin-free. Dilute meter to 2 centimeters thick. Reheat the 1.0 milliliter of n-hexadecane to 25 milliliters mixture at 160 °C ±1 °C for 2 hours, and store with isooctane and determine the absorbance in a tightly closed flask. in a 5-centimeter cell compared to isooctane Sodium sulfate, anhydrous, A.C.S. reagent as reference point between 280 mµ–400 mµ. grade, preferably in granular form. For each The absorbance per centimeter path length bottle of sodium sulfate reagent used, estab- shall not exceed 0.00 in this range. Purify, if lish as follows the necessary sodium sulfate necessary, by percolation through activated prewash to provide such filters required in silica gel or by distillation. the method: Place approximately 35 grams of Methyl alcohol, A.C.S. reagent grade. Use anhydrous sodium sulfate in a 30-milliliter 10.0 milliliters of methyl alcohol. Purify, if course, fritted-glass funnel or in a 65-milli- necessary, by distillation. meter filter funnel with glass wool plug; Dimethyl sulfoxide. Spectrophotometric wash with successive 15-milliliter portions of grade (Crown Zellerbach Corporation, the indicated solvent until a 15-milliliter Camas, Washington, or equivalent). Absorb- portion of the wash shows 0.00 absorbance ance (1-centimeter cell, distilled water ref- per centimeter path length between 280 mµ erence, sample completely saturated with ni- and 400 mµ when tested as prescribed under trogen). ‘‘Organic solvents.’’ Usually three portions of wash solvent are sufficient. Absorb- Wavelength ance (max- Before proceeding with analysis of a sam- imum) ple, determine the absorbance in a 5-centi- meter path cell between 250 millimicrons and 261.5 ...... 1.00 400 millimicrons for the reagent blank by 270 ...... 20 275 ...... 09 carrying out the procedure, without an oil 280 ...... 06 sample, recording the spectra after the ex- 300 ...... 015 traction stage and after the complete proce- dure as prescribed. The absorbance per centi- There shall be no irregularities in the ab- meter pathlength following the extraction sorbance curve within these wavelengths. stage should not exceed 0.02 in the wave- Phosphoric acid. 85 percent A.C.S. reagent length range from 280 mµ to 400 mµ; the ab- grade. sorbance per centimeter pathlength fol- Sodium borohydride. 98 percent. lowing the complete procedure should not Magnesium oxide (Sea Sorb 43, Food Machin- exceed 0.02 in the wavelength range from 280 ery Company, Westvaco Division, distributed by mµ to 400 mµ. If in either spectrum the char- chemical supply firms, or equivalent). Place 100 acteristic benzene peaks in the 250 mµ–260 grams of the magnesium oxide in a large mµ region are present, remove the benzene beaker, add 700 milliliters of distilled water by the procedure under ‘‘Organic solvents’’ to make a thin slurry, and heat on a steam and record absorbance again. bath for 30 minutes with intermittent stir- Place 300 milliliters of dimethyl sulfoxide ring. Stir well initially to insure that all the in a 1-liter separatory funnel and add 75 mil- adsorbent is completely wetted. Using a liliters of phosphoric acid. Mix the contents Buchner funnel and a filter paper (Schleicher of the funnel and allow to stand for 10 min- & Schuell No. 597, or equivalent) of suitable utes. (The reaction between the sulfoxide diameter, filter with suction. Continue suc- and the acid is exothermic. Release pressure tion until water no longer drips from the after mixing, then keep funnel stoppered.) funnel. Transfer the adsorbent to a glass Add 150 milliliters of isooctane and shake to trough lined with aluminum foil (free from pre-equilibrate the solvents. Draw off the in- rolling oil). Break up the magnesia with a dividual layers and store in glass-stoppered clean spatula and spread out the adsorbent flasks. on the aluminum foil in a layer about 1 cen- Weigh a 20-gram sample of the oil and timeter to 2 centimeters thick. Dry for 24 transfer to a 500-milliliter separatory funnel hours at 160 °C ±1 °C. Pulverize the magnesia containing 100 milliliters of pre-equilibrated with mortar and pestle. Sieve the pulverized sulfoxide-phosphoric acid mixture. Complete adsorbent between 60–180 mesh. Use the mag- the transfer of the sample with small por- nesia retained on the 180-mesh sieve. tions of preequilibrated isooctane to give a
388
VerDate 06
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 minute. Repeat the extraction operation used.) Immediately fit a water-cooled con- with two additional portions of the sulf- denser equipped with a 24/40 joint and with a oxide-acid mixture and wash each extractive drying tube into the flask, mix until the in tandem through the same three portions borohydride is dissolved, and allow to stand of isooctane. for 30 minutes at room temperature, with Collect the successive extractives (300 mil- intermittent swirling. At the end of this pe- liliters total) in a separatory funnel (pref- riod, disconnect the flask and evaporate the erably 2-liter) containing 480 milliliters of methyl alcohol on the steam bath under ni- distilled water; mix, and allow to cool for a trogen until the sodium borohydride begins few minutes after the last extractive has to come out of the solution. Then add 10 mil- been added. Add 80 milliliters of isooctane to liliters of isooctane and evaporate to a vol- the solution and extract by shaking the fun- ume of about 2–3 milliliters. Again, add 10 nel vigorously for 2 minutes. Draw off the milliliters of isooctane and concentrate to a lower aqueous layer into a second separatory volume of approximately 5 milliliters. Swirl funnel (preferably 2-liter) and repeat the ex- the flask repeatedly to assure adequate traction with 80 milliliters of isooctane. washing of the sodium borohydride residues. Draw off and discard the aqueous layer. Fit the tetrafluoroethylene polymer disc Wash each of the 80-milliliter extractives on the upper part of the stem of the three times with 100-milliliter portions of chromatographic tube, then place the tube distilled water. Shaking time for each wash with the disc on the suction flask and apply is 1 minute. Discard the aqueous layers. Fil- the vacuum (approximately 135 millimeters ter the first extractive through anhydrous Hg pressure). Weigh out 14 grams of the 2:1 sodium sulfate prewashed with isooctane (see magnesium oxide-Celite 545 mixture and Sodium sulfate under ‘‘Reagents and Mate- pour the adsorbent mixture into the rials’’ for preparation of filter) into a 250- chromatographic tube in approximately 3- milliliter Erlenmeyer flask (or optionally centimeter layers. After the addition of each into the evaporation flask). Wash the first layer, level off the top of the adsorbent with separatory funnel with the second 80-milli- a flat glass rod or metal plunger by pressing liter isooctane extractive and pass through down firmly until the adsorbent is well the sodium sulfate. Then wash the second packed. Loosen the topmost few millimeters and first separatory funnels successively of each adsorbent layer with the end of a with a 20-milliliter portion of isooctane and metal rod before the addition of the next 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 200-milliliter volumetric umn by passing 100 milliliters of isooctane flask, make to volume, and mix. Determine through the column. Adjust the nitrogen the absorbance of the solution in the 1-centi- pressure so that the rate of descent of the meter pathlength cells compared to iso- isooctane coming off the column is between octane as reference between 280 mµ–400 mµ 2–3 milliliters per minute. Discontinue pres- (take care to lose none of the solution in fill- sure just before the last of the isooctane ing the sample cell). Correct the absorbance reaches the level of the adsorbent. (Caution: values for any absorbance derived from re- Do not allow the liquid level to recede below agents as determined by carrying out the the adsorbent level at any time.) Remove the procedure without an oil sample. If the cor- reservoir and decant the 5–milliliter iso- rected absorbance does not exceed the limits octane concentrate solution onto the column prescribed in this paragraph, the oil 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
389
VerDate 06
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 reaches the top of the adsorbent, add 100 mil- petroleum distillates refined to meet liliters of isooctane to the reservoir and con- the following specifications: tinue the percolation at the 2–3 milliliters (i) Distillation endpoint at 760 milli- 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 colation at the aforementioned rate. Just be- Distillation of Petroleum Products,’’ fore the solvent mixture reaches adsorbent level, add 25 milliliters of 20 percent benzene which is incorporated by reference. The in isooctane to the reservoir and continue availability of this incorporation by the percolation at 2–3 milliliters per minute reference is given in paragraph (b)(1)(i) until all this solvent mixture has been re- of this section. moved from the column. Discard all the (ii) Ultraviolet absorbance limits as elution solvents collected up to this point. follows as determined by the method Add 300 milliliters of the acetone-benzene- described in paragraph (d)(3) of this water mixture to the reservoir and percolate through the column to eluate the section. polynuclear compounds. Collect the eluate in Maximum a clean 1-liter separatory funnel. Allow the absorb- column to drain until most of the solvent Wavelength (mµ) ance per mixture is removed. Wash the eluate three centimeter optical times with 300-milliliter portions of distilled pathlength water, shaking well for each wash. (The addi- tion of small amounts of sodium chloride fa- 280 to 299 ...... 2.3 cilitates separation.) Discard the aqueous 300 to 319 ...... 1.2 layer after each wash. After the final separa- 320 to 359 ...... 8 tion, filter the residual benzene through an- 360 to 400 ...... 3 hydrous sodium sulfate pre-washed with ben- zene (see Sodium sulfate under ‘‘Reagents (iii) Pyrene content not to exceed a and Materials’’ for preparation of filter) into maximum of 25 parts per million as de- a 250-milliliter Erlenmeyer flask (or option- termined by the method described in ally into the evaporation flask). Wash the paragraph (d)(3) of this section. separatory funnel with two additional 20- (2) The mineral oil may be used only milliliter portions of benzene which are also in the processing of jute fiber employed filtered through the sodium sulfate. Add 1 in the production of textile bags in- milliliter of n-hexadecane and completely re- move the benzene by evaporation under ni- tended for use in contact with the fol- trogen, using the special procedure to elimi- lowing types of food: Dry grains and nate benzene as previously described under dry seeds (for example, beans, peas, ‘‘Organic solvents.’’ Quantitatively transfer rice, and lentils); whole root crop vege- the residue with isooctane to a 200-milliliter tables of the types identified in 40 CFR volumetric flask and adjust to volume. De- 180.34(f); unshelled and shelled nuts (in- termine the absorbance of the solution in the cluding peanuts); and dry animal feed. 1-centimeter pathlength cells compared to The finished processed jute fiber shall isooctane as reference between 250 mµ–400 mµ. Correct for any absorbance derived from contain no more than 6 percent by the reagents as determined by carrying out weight of residual mineral oil. the procedure without an oil sample. If ei- (3) The analytical method for deter- ther spectrum shows the characteristic ben- mining ultraviolet absorbance limits zene peaks in the 250 mµ–260 mµ region, evap- and pyrene content is as follows: orate the solution to remove benzene by the procedure under ‘‘Organic solvents.’’ Dis- I. Apparatus. A. Assorted beakers, sepa- solve the residue, transfer quantitatively, ratory funnels fitted with tetrafluoro- and adjust to volume in isooctane in a 200- ethylene polymer stopcocks, and graduated milliliter volumetric flask. Record the ab- cylinders. sorbance again. If the corrected absorbance B. Volumetric flasks, 200-milliliter. does not exceed the limits proposed in this C. A chromatographic column made from × paragraph, the oil meets the proposed ultra- nominal 1.3 centimeters outside diameter violet absorbance specifications. 75 centimeters glass tubing tapered at one end and joined to a 2-millimeter-bore tetra- (d) Mineral oil identified in para- fluoroethylene polymer stopcock. The oppo- graph (d)(1) of this section may be used site end is flanged and joined to a female 24/
390
VerDate 06
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. dating the 500-milliliter reservoir described 1. Isooctane (2,2,4-trimethylpentane). Use 240 in item I. E below. milliliters for the above test. Purify, if nec- E. A 500-milliliter reservoir having a 24/40 essary, by passage through a column of acti- standard taper male fitting at bottom and a vated silica gel. suitable ball joint at the top for connecting 2. Benzene. Use 200 milliliters for the above to the nitrogen supply. The female fitting of test. Purify, if necessary, by distillation or the chromatographic columns described in otherwise. items I. C and D above and the male fitting 3. Cyclohexane. Use 70 milliliters for the of the reservoir described in this item E above test. Purify, if necessary, by distilla- should both be equipped with glass hooks. tion, silica gel percolation, or otherwise. (NOTE: Rubber stoppers are not to be used. 4. Nitromethane. Use 125 milliliters for the Stopcock grease is not to be used on ground- above test. Purify, if necessary, by distilla- glass joints in this method.) tion or otherwise. F. A spectrophotometer equipped to auto- 5. n-Hexadecane. Determine the absorbance matically record absorbance of liquid sam- on this solvent directly. Purify, if necessary, ples in 1-centimeter pathlength cells in the by silica gel percolation or otherwise. spectral region of 280–400 mµ with a spectral B. Other materials—1. Pyrene standard ref- slit width of 2 mµ or less. At an absorbance erence. Pyrene, reagent grade, melting point ° level of about 0.4, absorbance measurements range 150–152 C. (Organic Chemical 3627, shall be repeatable within ±0.01 and accurate Eastman Kodak Co., Rochester, N.Y., or within ±0.05. Wavelength measurements shall equivalent). The standard reference absorb- be repeatable with ±0.2 mµ and accurate ance is the absorbance at 334 millimicrons of within ±1.0 mµ. Instrument operating condi- a standard reference solution of pyrene con- tions are selected to realize this performance taining a concentration of 1.0 milligram per under dynamic (automatic) recording oper- liter in purified isooctane measured against ations. Accuracy of absorbance measure- isooctane of the same spectral purity in 1.0- ments are determined at 290, 345, and 400 mµ, centimeter cells. (This absorbance will be ap- using potassium chromate as the reference proximately 0.28.) standard. (National Bureau of Standards Cir- 2. Chrysene solution. Prepare a solution at a cular 484, Spectrophotometry, U.S. Depart- concentration of 5.0 milligrams per liter by ment of Commerce, 1949.) dissolving 5.0 milligrams of chrysene in puri- G. Two fused quartz cells having fied isooctane in a 1-liter volumetric flask. pathlengths of 1.00±0.005 centimeter or bet- Adjust to volume with isooctane. ter. 3. Nitrogen gas. Water pumped or equivalent II. Purity of reagents and materials. Reagent- purity, cylinder with regulator, and valve grade chemicals shall be used in all tests. It control flow at 5 p.s.i. is further specified that each chemical shall 4. Silica gel. 100–200 mesh (Davison Chem- be tested for purity in accordance with the ical, Baltimore, Md., Grade 923, or equiva- instruction given under ‘‘Reagents and Mate- lent), purified and activated by the following rials’’ in III below. In addition, a blank run procedure: Place about 1 kilogram of silica by the procedure shall be made on each puri- gel in a large column and wash with con- fied lot of reagents and materials. Unless taminant-free benzene until a 200-milliliter otherwise indicated, references to water sample of the benzene coming off the column shall be understood to mean distilled water. will pass the ultraviolet absorption test for III. Reagents and materials— A. Organic sol- benzene. This test is performed as stipulated vents. All solvents used throughout the pro- under ‘‘Organic solvents’’ in A under III cedure shall meet the specifications and above. When the silica gel has been suffi- tests described in this section III. The iso- ciently cleaned, activate the gel before use octane, benzene, cyclohexane, nitromethane, by placing the 1-kilogram batch in a shallow and n-hexadecane designated shall pass the container in a layer no greater than 1 inch in following test: To the specified quantity of depth and heating in an oven (Caution! Ex- solvent in a 150-milliliter beaker, add 1 milli- plosion Hazard) at 130 °C. for 16 hours, and liter of purified n-hexadecane and evaporate store in a vacuum desiccator. Reheating on the steam bath under a stream of nitro- about once a week is necessary if the silica
391
VerDate 06
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. sorbent Under Vacuum To Minimize Explo- (NOTE: If the amount of chrysene recovered sion Hazard in Subsequent Heating!) When is less than 80 percent, the original batch of the aluminum oxide has been sufficiently aluminum oxide should be sieved between cleaned and freed of solvent, activate it be- 100–160 mesh. Activation and testing of this fore use by placing the 1-kilogram batch in a sieved batch should indicate a satisfactory shallow container in a layer no greater than aluminum oxide for use.) 1 inch in depth. Heat in an oven at 130 °C for IV. Sampling. Precautions must be taken to 16 hours. Upon removal from heat, store at insure that an uncontaminated sample of the atmospheric pressure over 80 percent (by mineral oil is obtained since ultraviolet ab- weight) sulfuric acid in a desiccator for at sorption is very sensitive to small amounts least 36 hours before use. This gives alu- of extraneous material contaminating the minum oxide with between 6 to 9.5 percent sample through careless handling. volatiles. This is determined by heating a V. Procedure. A. Blank. Before proceeding weighed sample of the prepared aluminum with the analysis of a sample, determine the oxide at 2,000 °F for 2 hours and then quickly absorbance of the solvent residues by car- reweighing. To insure the proper adsorptive rying out the procedure without a sample. properties of the aluminum oxide, perform B. Sample. 1. Weigh out 20.0 grams ±0.1 the following test: gram of the mineral oil into a beaker and a. Weigh 50 grams ±1 gram of the activated transfer to a 250-milliliter separatory funnel aluminum oxide and pack into the fitted with a tetrafluoroethylene polymer chromatographic column (1.3 centimeters × stopcock, using enough cyclohexane (25 mil- 75 centimeters) described under ‘‘Apparatus’’ liliters) to give a final total volume of 50 in C under I above. Use glass wool at the col- milliliters (mineral oil plus cyclohexane). umn exit to prevent the aluminum oxide 2. Add 25 milliliters of nitromethane satu- from passing through the column. rated with cyclohexane and shake by hand b. Place a 250-milliliter graduated cylinder vigorously for 3 minutes. Recover the lower under the column to measure the amount of nitromethane layer in a 150-milliliter beaker eluate coming from the column. containing 1 milliliter of n-hexadecane and c. Prewet the aluminum oxide by passing evaporate on the steam bath under nitrogen. 40 milliliters of isooctane through the col- Repeat the extraction four more times, re- umn. Adjust the nitrogen pressure so that covering each extract in the 150-milliliter the rate of descent of the isooctane coming beaker. Exercise care not to fill the beaker off the column is between 1.5 to 2.5 milli- to such a capacity that solvent losses may liters per minute. occur. Evaporate the combined d. Just prior to the last of the isooctane nitromethane extracts to 1 milliliter of n- reaching the top of the aluminum oxide bed, hexadecane residue containing the add 10 milliliters of the isooctane solution nitromethane-soluble mineral oil extrac- containing 5.0 milligrams of chrysene per tives. (NOTE: Complete removal of the liter. nitromethane is essential. This can be as- e. Continue percolation until the isooctane sured by two successive additions of 5 milli- is just above the aluminum oxide. Then add liters of isooctane and reevaporation.) 200 milliliters of a mixture of benzene and 3. Remove the beaker from the steam bath isooctane (331⁄3 percent benzene and 662⁄3 per- and allow to cool. cent isooctane by volume) to the reservoir 4. Weigh 50 grams ±1 gram of activated alu- and continue percolation. minum oxide and pack into the f. Continue percolation, collecting the chromatographic column (1.3 centimeters × eluates (40 milliliters of the prewet solution, 75 centimeters) described under ‘‘Apparatus’’ 10 milliliters of the sample solution, and 200 in C under I above. (NOTE: A small plug of milliliters of the gradient solution) in the glass wool is placed at the column exit to 250-milliliter graduated cylinder until the prevent the aluminum oxide from passing level of the gradient solution is just above through the column. After adding aluminum the aluminum oxide. Add 200 milliliters of oxide, tap the column lightly to remove air the eluting solution of benzene and isooctane voids. All percolations using aluminum oxide (90 percent benzene and 10 percent isooctane are performed under nitrogen pressure. The
392
VerDate 06
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- photo-oxidation effects, the following proce- percent nitro-methane and 71 weight-percent dures (steps 6 through 18) shall be carried out silica gel. in subdued light. 15. Place a small plug of glass wool in the 6. Before the last of the isooctane reaches tapered end of the 1.7 centimeters outside di- the top of the aluminum oxide bed, release ameter × 115 centimeters column, described the nitrogen pressure and turn off the stop- under ‘‘Apparatus’’ in D of I above, adjacent cock on the column. Transfer the n-hexa- to the stopcock to prevent silica gel from decane residue from the 150-milliliter beaker passing through the stopcock. Pack the from procedure step 3 above onto the col- nitromethane-treated silica gel into the col- umn, using several washes of isooctane (total umn, tapping lightly. The resultant silica gel volume of washes should be no greater than bed should be about 95 centimeters in depth. 10–15 milliliters). Place into a flask 170 milliliters of isooctane 7. Open the stopcock and continue percola- saturated with nitromethane. tion until the isooctane is about 1 centi- 16. Place a 100-milliliter graduated cyl- meter above the top of the aluminum oxide inder under the column and transfer the res- bed. Add 200 milliliters of isooctane to the idue from the beaker in procedure step 13 reservoir, and continue the percolation at above with several washes of the 170 milli- the specified rate. liters of isooctane, saturated with 8. Just before the isooctane surface reaches nitromethane, onto the top of the column. the top of the aluminum oxide bed, add 200 (Total volume of washes should be no greater milliliters of a mixture of benzene and iso- than 10 to 15 milliliters.) Permit isooctane octane (331⁄3 percent benzene and 662⁄3 percent solution to enter the silica gel bed until the isooctane by volume) to the reservoir, and liquid level is at the top bed level. Place the continue the percolation. remaining amount of the 170 milliliters of 9. Just before the surface of this mixture isooctane, saturated with nitromethane, in reaches the top of the aluminum oxide bed, the reservoir above the bed for percolation release the nitrogen pressure, turn off the through the silica gel. Apply nitrogen pres- stopcock, and discard all the elution solvents sure to the top of the column, adjusting the collected up to this point. pressure so that the isooctane is collected at 10. Add to the reservoir 300 milliliters of a the rate of 2.5 to 3.5 milliliters per minute, mixture of benzene and isooctane (90 percent and percolate isooctane through the bed benzene and 10 percent isooctane by volume), until a quantity of 75.0 milliliters of eluate is place a 25-milliliter graduated cylinder collected. Discard the 75 milliliters of eluate. under the column, continue the percolation Turn off the stopcock and add 250 milliliters until 20 milliliters of eluate has been col- of benzene to the reservoir above the bed. lected, and then discard the eluate. Use a 400-milliliter beaker to collect the re- 11. At this point, place a clean 250-milli- maining eluate. liter Erlenmeyer flask under the column. 17. Open the stopcock, renew the pressure, Continue the percolation and collect all the and percolate the remaining isooctane and remaining eluate. benzene through the column eluting the re- (NOTE: Allow the column to drain com- maining aromatics. Transfer the eluate in pletely. An increase in the nitrogen pressure small portions from the 400 milliliter beaker may be necessary as the last of the solvent to a 150-milliliter beaker containing 1 milli- comes off the column.) liter of n-hexadecane and evaporate on the 12. Place 1 milliliter of n-hexadecane into a steam bath under nitrogen. Rinse the 400- 150-milliliter beaker. Place this onto a steam milliliter beaker well with small portions of bath under a nitrogen stream and transfer in isooctane to obtain a complete transfer. small portions the eluate from step 11 above. (NOTE: Complete removal of the Wash out the Erlenmeyer flask with small nitromethane and benzene is essential. This amounts of benzene and transfer to the evap- can be assured by successive additions of 5 oration beaker. Evaporate until only 1 milli- milliliters of isooctane and reevaporation.) liter of hexadecane residue remains. (NOTE: 18. Transfer the residue with several wash- Complete removal of the benzene is essen- es of isooctane into a 200-milliliter volu- tial. This can be assured by two successive metric flask. Add isooctane to mark.
393
VerDate 06
19. Record the spectrum of the sample solu- absorbances corrected for pyrene content as tion in a 1-centimeter cell compared to iso- described in this step 19 for each of the speci- octane from 270 to 400 mµ. After making nec- fied wavelength intervals shall not exceed essary corrections in the spectrum for cell the limits prescribed in paragraph (d)(1)(ii) differences and for the blank absorbance, of this section. record the maximum absorbance in each of d. If the spectrum as a whole of the sample the wavelength intervals (mµ), 280–299, 300– solution is in any respect clearly incompat- 319, 320–359, 360–400. ible with the presence of pyrene as the a. If the spectrum then shows no discern- source of the peak at 334 mµ, then the max- ible peak corresponding to the absorbance imum absorbances in the respective wave- maximum of the pyrene reference standard length intervals without correction for any µ solution at 334 m , the maximum assumed pyrene content shall not exceed the absorbances in the respective wavelength in- limits prescribed in paragraph (d)(1)(ii) of tervals recorded shall not exceed those pre- this section. scribed in paragraph (d)(1)(ii) of this section. b. If such a peak is evident in the spectrum [42 FR 14609, Mar. 15, 1977, as amended at 47 of the sample solution, and the spectrum as FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, a whole is not incompatible with that of a 1984; 54 FR 24898, June 12, 1989] pyrene contaminant yielding such a peak of the observed absorbance, calculate the con- § 178.3650 Odorless light petroleum hy- centration of pyrene that would yield this drocarbons. peak (334 m) by the base-line technique de- scribed in ASTM method E169–63 (Re- Odorless light petroleum hydro- approved 1981), ‘‘Standard Recommended carbons may be safely used, as a com- Practices for General Techniques of Ultra- ponent of nonfood articles intended for violet Quantitative Analysis,’’ which is in- use in contact with food, in accordance corporated by reference. The availability of with the following prescribed condi- this incorporation by reference is given in paragraph (b)(1)(i) of this section. Correct tions: each of the maximum absorbances in the re- (a) The additive is a mixture of liquid spective specified wavelength intervals by hydrocarbons derived from petroleum subtracting the absorbance due to pyrene, or synthesized from petroleum gases. determined as follows: The additive is chiefly paraffinic, Cp × Sa isoparaffinic, or naphthenic in nature. Absorbance due to pyrene = (b) The additive meets the following Sp specifications: (1) Odor is faint and not kerosenic. where: Cp=Calculated concentration of pyrene in (2) Initial boiling point is 300 °F min- sample solution; imum. Sp=Concentration of pyrene reference stand- (3) Final boiling point is 650 °F max- ard solution in same units of concentra- imum. tion; Sa=Absorbance of pyrene reference standard (4) Ultraviolet absorbance limits de- solution at wavelength of maximum ab- termined by method specified in sorbance of sample solution in the respec- § 178.3620(b)(1)(ii), as follows: tive specified wavelength intervals. Also calculate the pyrene content of the Maximum absorb- oil sample in parts per million as follows: µ ance per Wavelength (M ) centimeter Pyrene content (/)200 1000 × C optical = = 10C pathlength (p.p.m.) 20/ 1000 280 to 289 ...... 4.0 where: 290 to 299 ...... 3.3 C=Calculated concentration of pyrene in mil- 300 to 329 ...... 2.3 ligrams per liter of sample solution. 330 to 360 ...... 8 c. The pyrene content so determined shall not exceed 25 p.p.m. The maximum (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.
394
VerDate 06
Use Limitations
As a defoamer in coatings ...... Complying with § 176.200 of this chapter.
§ 178.3690 Pentaerythritol adipate-ste- (3) Saponification number of 270–280 arate. as determined by ASTM method D1387– Pentaerythritol adipate-stearate 78, ‘‘Standard Test Method for Acid identified in paragraph (a) of this sec- Number (Empirical) of Synthetic and Natural Waxes’’ (Revised 1978), which is tion may be safely used as a lubricant incorporated by reference. Copies are in the fabrication of rigid and semi- available from American Society for rigid polyvinyl chloride and/or vinyl Testing and Materials (ASTM), 1916 chloride-propylene copolymers com- Race Street, Philadelphia, PA 19103, or plying with § 177.1980 of this chapter available for inspection at the Office of used as articles or components of arti- the Federal Register, 800 North Capitol cles that contact food, excluding food Street, NW., suite 700, Washington, DC with alcohol content greater than 8 20408. percent under conditions of use of E, F, (4) Iodine number not to exceed 2 as and G described in table 2 in § 175.300(d) determined by Iodine Absorption Num- of this chapter, subject to the provi- ber, Hanus Method, of the ‘‘Official sions of this section. Methods of Analysis of the Association (a) Identity. For the purpose of this of Official Analytical Chemists,’’ sec- section, pentaerythritol adipate-stea- tions 28.018–28.019, 13th Ed. (1980), which rate is an ester of pentaerythritol with is incorporated by reference. Copies adipic acid and stearic acid and its as- may be obtained from the Association sociated fatty acids (chiefly palmitic), of Official Analytical Chemists Inter- with adipic acid comprising 14 percent national, 481 North Frederick Ave., and stearic acid and its associated suite 500, Gaithersburg, MD 20877–2504, acids (chiefly palmitic) comprising 71 or may be examined at the Office of the percent of the organic moieties. Federal Register, 800 North Capitol (b) Specifications. Pentaerythritol adi- Street, NW., suite 700, Washington, DC pate-stearate has the following speci- 20408. fications: (c) The total amount of ester (cal- (1) Melting point (dropping) of 55–58 culated as free pentaerythritol) shall °C as determined by ASTM method not exceed 0.4 percent by weight of the D566–76 (Reapproved 1982), ‘‘Standard polyvinyl chloride and/or the vinyl Test Method for Dropping Point of Lu- chloride-propylene copolymers com- bricating Grease,’’ which is incor- plying with § 177.1980. porated by reference. Copies may be [45 FR 1018, Jan. 4, 1980, as amended at 47 FR obtained from the American Society 11848, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984; for Testing Materials, 1916 Race St., 54 FR 24898, June 12, 1989; 57 FR 18082, Apr. Philadelphia, PA 19103, or may be ex- 29, 1992] amined at the Office of the Federal Register, 800 North Capitol Street, § 178.3700 Petrolatum. NW., suite 700, Washington, DC 20408. Petrolatum may be safety used as a (2) Acid value not to exceed 15 as de- component of nonfood articles in con- termined by ASTM method D1386–78, tact with food, in accordance with the ‘‘Standard Test Method for Saponifica- following conditions: tion Number (Empirical) of Synthetic (a) Petrolatum complies with the and Natural Waxes’’ (Revised 1978), specifications set forth in the United which is incorporated by reference. States Pharmacopeia XX (1980) for Copies are available from American So- white petrolatum or in the National ciety for Testing and Materials Formulary XV (1980) for yellow petro- (ASTM), 1916 Race Street, Philadel- latum. phia, PA 19103, or available for inspec- (b) Petrolatum meets the following tion at the Office of the Federal Reg- ultraviolet absorbance limits when ister, 800 North Capitol Street, NW., subjected to the analytical procedure suite 700, Washington, DC 20408. described in § 172.886(b) of this chapter:
395
VerDate 06
Ultraviolet absorbance per centi- Millimicrons Maximum meter pathlength: 280 to 289 ...... 0.15 290 to 299 ...... 12 Millimicrons Maximum 300 to 359 ...... 08 280 to 289 ...... 0.25 360 to 400 ...... 02 290 to 299 ...... 20 300 to 359 ...... 14 (c) Petroleum wax may contain any 360 to 400 ...... 04 antioxidant permitted in food by regu- lations issued in accordance with sec- (c) It is used or intended for use as a tion 409 of the act, in an amount not protective coating of the surfaces of greater than that required to produce metal or wood tanks used in fermenta- its intended effect. tion process, in an amount not in ex- (d) Petroleum wax may contain a cess of that required to produce its in- total of not more than 1 weight percent tended effect. of residues of the following polymers (d) Petrolatum as defined by this sec- when such residues result from use of tion may be used for the functions de- the polymers as processing aids (filter scribed and within the limitations pre- aids) in the production of the petro- scribed by specific regulations in parts leum wax: Homopolymers and/or co- 175, 176, 177, and 178 of this chapter polymers derived from one or more of which prescribe uses of petrolatum. the mixed n-alkyl (C12, C14, C16, and C18) For the purpose of cross-reference, methacrylate esters where the C12 and such specific regulations include: C14 alkyl groups are derived from coco- §§ 175.105, 175.125, 175.300, 176.170, 176.200, nut oil and the C16 and C18 groups are 176.210, 177.2600, 177.2800, and 178.3570 of derived from tallow. this chapter. (e) Petroleum wax may contain 2-hy- droxy-4-n-octoxybenzophenone as a sta- (e) Petrolatum may contain any anti- bilizer at a level not to exceed 0.01 oxidant permitted in food by regula- weight percent of the petroleum wax. tions issued pursuant to section 409 of (f) Petroleum wax may contain the act, in an amount not greater than poly(alkylacrylate) (CAS Reg. No. that required to produce its intended 27029–57–8), as described in § 172.886(c)(2) effect. of this chapter, as a processing aid in [42 FR 14609, Mar. 15, 1977, as amended at 49 the manufacture of petroleum wax. FR 10113, Mar. 19, 1984; 55 FR 12172, Apr. 2, [42 FR 14609, Mar. 15, 1977, as amended at 51 1990] FR 19545, May 30, 1986]
§ 178.3710 Petroleum wax. § 178.3720 Petroleum wax, synthetic. Petroleum wax may be safely used as Synthetic petroleum wax may be a component of nonfood articles in con- safely used in applications and under tact with food, in accordance with the the same conditions where naturally following conditions: derived petroleum wax is permitted in (a) Petroleum wax is a mixture of subchapter B of this chapter as a com- solid hydrocarbons, paraffinic in na- ponent of articles intended to contact ture, derived from petroleum, and re- food, provided that the synthetic petro- fined to meet the specifications pre- leum wax meets the definition and scribed in this section. specifications prescribed in § 172.888 of (b) The petroleum wax meets the fol- this chapter. lowing ultraviolet absorbance limits when subjected to the analytical proce- § 178.3725 Pigment dispersants. dure described in § 172.886(b) of this Subject to the provisions of this reg- chapter. ulation, the substances listed in this Ultraviolet absorbance per centi- section may be safely used as pigment meter pathlength: dispersants in food-contact materials.
396
VerDate 06
Substances Limitations
Phosphorylated tall oil fatty acids (CAS Reg. No. 68604±99±9), For use only at levels not to exceed 1.0 percent by weight of prepared by the reaction of dimethyl hydrogen phosphite the pigment. The pigmented polymeric films may contact all with tall oil fatty acids. food under conditions of use D, E, F, and G described in table 2 of § 176.170(c) of this chapter. Siloxanes and silicones; cetylmethyl, dimethyl, methyl 11- For use only at levels not to exceed 0.5 percent by weight of methoxy-11-oxoundecyl (CAS Reg. No. 155419±59±3).. the pigment. The pigmented polymers may contact all foods under conditions of use C, D, E, F, and G described in Table 2 of § 176.170(c) of this chapter.
[61 FR 43157, Aug. 21, 1996, as amended at 63 § 178.3740 Plasticizers in polymeric FR 35799, July 1, 1998] substances. § 178.3730 Piperonyl butoxide and Subject to the provisions of this reg- pyrethrins as components of bags. ulation, the substances listed in para- graph (b) of this section may be safely Piperonyl butoxide in combination used as plasticizers in polymeric sub- with pyrethrins may be safely used for stances used in the manufacture of ar- insect control on bags that are in- ticles or components of articles in- tended for use in contact with dried tended for use in producing, manufac- feed in compliance with §§ 561.310 and turing, packing, processing, preparing, 561.340 of this chapter, or that are in- treating, packaging, transporting, or tended for use in contact with dried holding food. food in compliance with §§ 193.60 and (a) The quantity used shall not ex- 193.390 of this chapter. ceed the amount reasonably required to accomplish the intended technical effect. (b) List of substances:
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 (1,700± For use at levels not exceeding 33 percent by weight of polyvinyl chloride 2,200 molecular weight) terminated with a 16 homopolymers used in contact with food (except foods that contain more percent by weight mixture of myristic, palmitic, than 8 percent of alcohol) at temperatures not to exceed room tempera- and stearic acids. ture. The average thickness of such homopolymers in the form in which they contact food shall not exceed 0.004 inch.
397
VerDate 06
Substances Limitations
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. Di(2-ethylhexyl) adipate ......
398
VerDate 06
Substances Limitations
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, IV±B, VI±B, and VIII. Diphenyl phthalate ...... For use only: 1. As provided in § 175.105 of this chapter. 2. Alone or in combination with other phthalates, in plastic film or sheet 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.
399
VerDate 06
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 D445±82 (``Standard 2. In polyethylene complying with § 177.1520 of this chapter and used in Test Method for Kinematic Viscosity of Trans- contact with fatty food, provided that the hydrogenated polybutene is parent and Opaque Liquids (and the Calculation added in an amount not to exceed 0.5 pct by weight of the polyethylene, of Dynamic Viscosity)'') and D2161±82 (``Stand- and further provided that such plasticized polyethylene shall not be used ard Method for Conversion of Kinematic Vis- as a component of articles intended for packing or holding food during cosity to Saybolt Universal Viscosity or to cooking. Saybolt Furol Viscosity''), and bromine number 3. In polystyrene complying with § 177.1640 of this chapter and used in of 3 or less, as determined by ASTM method contact with fatty food, provided that the hydrogenated polybutene is D1492±78 (``Standard Test Method for Bromine added in an amount not to exceed 5 pct by weight of the polystyrene, Index of Aromatic Hydrocarbons by Coulometric and further provided that such plasticized polystyrene shall not be used Titration''), which are incorporated by reference. as a component of articles intended for packing or holding food during Copies may be obtained from the American So- cooking. ciety for Testing Materials, 1916 Race St., Phila- delphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Polyisobutylene (mol weight 300±5,000) ...... For use in polyethylene complying with § 177.1520 of this chapter, provided that the polyisobutylene is added in an amount not exceeding 0.5 pct by weight of the polyethylene, and further provided that such plasticized 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. 25322±69± For use only in polystyrene plastics, identified in § 177.1640(a)(1), in an 4) (minimum mean molecular weight 1,200). amount not to exceed 6 pct by weight of the finished food-contact article. Propylene glycol azelate (average mol. weight For use only at levels not exceeding 41 pct by weight of permitted polyvinyl 3,000). chloride coatings. Such coatings shall be used only as bulk food contact surfaces of articles intended for repeated use, complying with § 177.2600 of this chapter. Triethylene glycol ...... Diethylene glycol content not to exceed 0.1 pct. 2,2,4-Trimethyl-1,3-pentanediol diisobutyrate ...... For use only in cellulosic plastics in an amount not to exceed 15 pct by weight of the finished food-contact article, provided that the finished plas- tic article contacts food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, VI±B, VII±B, and VIII.
(c) The use of the plasticizers in any ular weight is 350 or higher and no polymeric substance or article subject more than 0.5 percent total by weight to any regulation in parts 174, 175, 176, of ethylene and diethylene glycols if its 177, 178 and 179 of this chapter must mean molecular weight is below 350, comply with any specifications and when tested by the analytical methods limitations prescribed by such regula- prescribed in § 172.820(b) of this chapter. tion for the finished form of the sub- (c) The provisions of paragraph (b) of stance or article. this section are not applicable to poly- [42 FR 14609, Mar. 15, 1977, as amended at 42 ethylene glycols used in food-pack- FR 44223, Sept. 2, 1977; 45 FR 56052, Aug. 22, aging adhesives complying with 1980; 48 FR 5748, Feb. 15, 1984; 49 FR 10113, § 175.105 of this chapter. Mar. 19, 1984; 51 FR 47011, Dec. 30, 1986] § 178.3760 Polyethylene glycol (400) § 178.3750 Polyethylene glycol (mean monolaurate. molecular weight 200–9,500). Polyethylene glycol (400) Polyethylene glycol identified in this monolaurate containing not more than section may be safely used as a compo- 0.1 percent by weight of ethylene and/ nent of articles intended for use in con- or diethylene glycol may be used at a tact with food, in accordance with the level not to exceed 0.3 percent by following prescribed conditions: weight of twine as a finish on twine to (a) The additive is an addition poly- be used for tying meat provided the mer of ethylene oxide and water with a twine fibers are produced from nylon mean molecular weight of 200 to 9,500. resins complying with § 177.1500 of this (b) It contains no more than 0.2 per- chapter. cent total by weight of ethylene and diethylene glycols if its mean molec-
400
VerDate 06
§ 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
401
VerDate 06
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
402
VerDate 06
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
403
VerDate 06
‘‘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-
404
VerDate 06
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.
405
VerDate 06
(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
406
VerDate 06
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
407
VerDate 06
(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
408
VerDate 06
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. 25359±91±5). parts of reactors employed in the production of polyvinyl chloride and acrylic copolymers, provided that the residual levels of the additive in the ploymer do not exceed 4 parts per million. N,N′-Dioleoylethylenediamine ...... For use only in polyvinyl chloride films in amounts such that the 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. 70892±21±6) produced by the tapes at levels not to exceed 0.2 milligram per square centimeter (1.29 reaction between stoichiometrically equivalent milligrams per square inch) of backing. amounts of octadecyl isocyanate and vinyl 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.
409
VerDate 06
(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
410
VerDate 06
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.
411
VerDate 06
(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. 9038±95±3) produced by random condensation of a 1:1 mixture by weight of ethylene oxide and propylene oxide with butanol and having a minimum molecular weight of 1,000. α±Butyl±Ω±hydroxypoly(oxypropylene) (CAS Reg. No. 9003- 13±8) having a minimum molecular weight of 1000. α±Lauroyl±Ω±hydroxpoly(oxyethylene) (CAS Reg. No. 9004± 81±3) having a minimum molecular weight of 200. Acetate esters derived from synthetic straight chain alcohols (complying with § 172.864 of this chapter) that have even numbers of carbon atoms in the range C8–C18. alpha±Alkyl±omega±hydroxypoly(oxyethylene) produced by the condensation of 1 mole of C12¥C15 straight chain primary al- cohols with an average of 3 moles of ethylene oxide (CAS Reg. No. 6002±97±1). Benzotriazole (CAS Reg. No. 95±14±7) ......
412
VerDate 06
List of substances Limitations
Bis(hydrogenated tallow alkyl)amine (CAS Reg. No. 61789± Not to be used in combination with sodium nitrite. 79±5). Bis(hydrogenated tallow alkyl)aminoethanol (CAS Reg. No. 116438±56±3). N,N-Bis(2-hydroxyethyl)butylamine (CAS Reg. No. 102±79±4) Tert-Butyl alcohol. Di(2-ethylhexyl)phthalate. Diethyl phthalate. Diethylene glycol monobutylether (CAS Reg. No. 112±34±5) .... Dimers, trimers, and/or their partial methyl esters; such dimers For use only at a level not to exceed 10 percent by weight of and trimers are of unsaturated C18 fatty acids derived from finished lubricant formulation. animal and vegetable fats and oils and/or tall oil, and such partial methyl esters meet the following specifications: Sa- ponification value 180±200, acid value 70±130, and max- imum iodine value 120. Di-n-octyl sebacate. Ethylenediaminetetraacetic acid, sodium salts. Isopropyl alcohol. Isopropyl oleate. Isotridecyl alcohol, ethoxylated (CAS Reg. No. 9043±30±5). Methyl esters of coconut oil fatty acids. Methyl esters of fatty acids (C16–C18) derived from animal and vegetable fats and oils. Polybutene, hydrogenated: complying with the identity pre- scribed under § 178.3740(b). Polyethylene glycol (400) monostearate. Polyisobutylene (minimum molecular weight 300). Polyoxyethylated (5 moles) tallow amine (CAS Reg. No. 61791±26±2). Polyvinyl alcohol. Sodium nitrite ...... For use only as a rust inhibitor in lubricant formulations 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 440±450 (CAS Reg. No. 68608±24±4) derived from naphthenic oil having a Saybolt viscosity range of 500±600 Saybolt Universal Seconds (SUS at 37±8 °C (100 °F) as determined by ASTM method D88± 81, ``Standard Test Method for Saybolt Viscosity,'' which is incorporated by reference. Copies are available from the American Society for Testing Materials, 1961 Race St., Philadelphia, PA 19103, or available for inspection at the Of- fice of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Synthetic alcohol mixture of straight-and branched-chain 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, 266±276. Synthetic primary alcohol mixture of straight- and branched- For use only at a level not to exceed 8 pct by weight of the fin- chain alcohols that contain at least 99 pct primary alcohols ished lubricant formulation. consisting of the following: not less than 70 percent normal alcohols; not less than 93 pct C12–C13 alcohols; not more than 5 pct C14–C15 alcohols; and not more than 2.5 pct alpha, omega, C13–C16 diols. The alcohols are prepared from linear olefins from a purified kerosene fraction, carbon 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, 283±296.
413
VerDate 06
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: 280±289 ...... 0.7 (a) Initial boiling point is 24 °C min- 290±299 ...... 6 300±359 ...... 4 imum and final boiling point is 288 °C 360±400 ...... 09 maximum, as determined by ASTM method D86–82, ‘‘Standard Method for (iii) The analytical method for deter- Distillation of Petroleum Products,’’ mining ultraviolet absorbance limits which is incorporated by reference. on residual lubricants is as follows: Copies may be obtained from the Amer- ican Society for Testing Materials, 1916 GENERAL INSTRUCTIONS Race St., Philadelphia, PA 19103, or Because of the sensitivity of the test, the may be examined at the Office of the possibility of errors arising from contamina- Federal Register, 800 North Capitol tion is great. It is of the greatest importance Street, NW., suite 700, Washington, DC that all glassware be scrupulously cleaned to 20408. remove all organic matter such as oil, grease, detergent, residues, etc. Examine all (b) Nonvolatile residue is 0.005 gram glassware including stoppers and stopcocks, per 100 milliliters, maximum, as deter- under ultraviolet light to detect any residual mined by ASTM method D381–80, fluorescent contamination. As a pre- ‘‘Standard Test Method for Existent cautionary measure it is recommended prac- Gum in Fuels by Jet Evaporation,’’ tice to rinse all glassware with purified iso- when the final boiling point is 121 °C or octane immediately before use. No grease is above and by ASTM method D1353–78, to be used on stopcocks or joints. Great care to avoid contamination of oil samples in ‘‘Standard Test Method for Nonvolatile handling and to assure absence of any extra- Matter in Volatile Solvents for Use in neous material arising from inadequate Paint, Varnish, Lacquer, and Related packaging is essential. Because some of the Products,’’ when the final boiling point polynuclear hydrocarbons sought in this test is below 121 °C. These ASTM methods are very susceptible to photo-oxidation, the are incorporated by reference. The entire procedure is to be carried out under availability of these incorporations by subdued light. reference is given in paragraph APPARATUS (a)(4)(i)(a) of this section. (c) Saybolt color 20 minimum as de- Separatory funnels. 250-milliliter, 500-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
414
VerDate 06
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.
415
VerDate 06
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
416
VerDate 06
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. 80939±62±4). Polyethylene glycol (molecular weight 300 or greater) ...... Mono- and diethylene glycol content not to exceed a total of 0.2 pct. Stannous stearate. Stearic acid amide. Stearyl stearate. Tetrakis[methylene (3,5-di-tert-butyl-4-hydroxyhydrocinnamate)] For use at a level not to exceed 0.5 percent by weight of the methane (CAS Registry No. 6683±19±8). finished surface lubricant formulation. Triethylene glycol ...... Diethylene glycol content not to exceed 0.1 pct. Wax, petroleum ...... Complying with § 178.3710.
(c) The substances identified in para- plish the intended technical effect and graph (a)(2) of this section may be used shall not be intended to nor, in fact, in surface lubricants used to facilitate accomplish any technical effect in the the drawing, stamping, and forming of food itself. metallic articles from rolled foil and (e) The use of the surface lubricants sheet stock provided that total resid- in the manufacture of any article that ual lubricant remaining on the metal- is the subject of a regulation in parts lic article in the form in which it con- 174, 175, 176, 177, 178 and § 179.45 of this tacts food does not exceed 0.015 milli- chapter must comply with any speci- gram per square inch of food-contact fications prescribed by such regulation surface. for the finished form of the article. (d) Subject to any prescribed limita- (f) Any substance that is listed in tions, the quantity of surface lubricant this section and the subject of a regula- used in the manufacture of metallic ar- tion in parts 174, 175, 176, 177, 178 and ticles shall not exceed the least § 179.45 of this chapter shall comply amount reasonably required to accom-
417
VerDate 06
with any applicable specifications pre- bination, or it may be used as a solvent scribed by such regulation. in the casting of film prepared from vinyl chloride copolymers complying [42 FR 14609, Mar. 15, 1977, as amended at 48 FR 238, Jan. 4, 1983; 49 FR 10113, Mar. 19, 1984; with § 177.1980 of this chapter. 49 FR 29579, July 23, 1984; 50 FR 36874, Sept. (b) The residual amount of tetra- 10, 1985; 52 FR 10223, Mar. 31, 1987; 54 FR 6124, hydrofuran in the film does not exceed Feb. 8, 1989; 54 FR 24899, June 12, 1989; 56 FR 1.5 percent by weight of film. 55456, Oct. 28, 1991; 57 FR 23953, June 5, 1992; 58 FR 17513, Apr. 5, 1993] 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 Subpart A Reserved used as components of polypropylene [ ] film intended for use in contact with Subpart B—Radiation and Radiation food, and the terpene resins identified Sources in paragraph (b) of this section may be 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 food, and for controlling food processing. (a) Terpene resins consisting of the 179.25 General provisions for food irradia- hydrogenated polymers of terpene hy- tion. drocarbons obtainable from sulfate tur- 179.26 Ionizing radiation for the treatment pentine and meeting the following of food. specifications: Drop-softening point of 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- essing and treatment of food. following specifications: Acid value 179.41 Pulsed light for the treatment of less than 1; saponification number less food. than 1; color less than 4 on the Gardner scale as measured in 50 percent mineral Subpart C—Packaging Materials for spirits solution. Irradiated Foods
§ 178.3940 Tetraethylene glycol di-(2- 179.45 Packaging materials for use during ethylhexoate). 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/ SOURCE: 42 FR 14635, Mar. 15, 1977, unless or diethylene glycols may be used at a otherwise noted. level not to exceed 0.7 percent by weight of twine as a finish on twine to Subpart A [Reserved] be used for tying meat provided the twine fibers are produced from nylon Subpart B—Radiation and resins complying with § 177.1500 of this Radiation Sources chapter. § 179.21 Sources of radiation used for § 178.3950 Tetrahydrofuran. inspection of food, for inspection of Tetrahydrofuran may be safely used packaged food, and for controlling in the fabrication of articles intended food processing. for packaging, transporting, or storing Sources of radiation for the purposes foods, subject to the provisions of this of inspection of foods, for inspection of section. packaged food, and for controlling food (a) It is used as a solvent in the cast- processing may be safely used under ing of film from a solution of poly- the following conditions: meric resins of vinyl chloride, vinyl ac- (a) The radiation source is one of the etate, or vinylidene chloride that have following: been polymerized singly or copolym- (1) X-ray tubes producing X-radiation erized with one another in any com- from operation of the tube source at
418
VerDate 06
energy levels of 300 kilovolt peak or treatment and processing of pre- lower. packaged foods shall comply with (2) Sealed units producing radiations § 179.45. at energy levels of not more than 2.2 (d) Radiation treatment of food shall million electron volts from one of the conform to a scheduled process. A following isotopes: Americium-241, ce- scheduled process for food irradiation sium-137, cobalt-60, iodine-125, krypton- is a written procedure that ensures 85, radium-226, and strontium-90. that the radiation dose range selected (3) Sealed units producing neutron by the food irradiation processor is radiation from the isotope Califor- adequate under commercial processing nium-252 (CAS Reg. No. 13981–17–4) to conditions (including atmosphere and measure moisture in food. temperature) for the radiation to (b) To assure safe use of these radi- achieve its intended effect on a specific ation sources: product and in a specific facility. A (1) The label of the sources shall food irradiation processor shall operate bear, in addition to the other informa- with a scheduled process established by tion required by the Act: qualified persons having expert knowl- (i) Appropriate and accurate informa- edge in radiation processing require- tion identifying the source of radi- ments of food and specific for that food ation. and for that irradiation processor’s (ii) The maximum energy of radi- treatment facility. ation emitted by X-ray tube sources. (e) A food irradiation processor shall (2) The label or accompanying label- maintain records as specified in this ing shall bear: section for a period of time that ex- (i) Adequate directions for installa- ceeds the shelf life of the irradiated tion and use. food product by 1 year, up to a max- (ii) A statement that no food shall be imum of 3 years, whichever period is exposed to radiation sources listed in shorter, and shall make these records paragraph (a) (1) and (2) of this section available for inspection and copy by so as to receive an absorbed dose in ex- authorized employees of the Food and cess of 10 grays. Drug Administration. Such records (iii) A statement that no food shall shall include the food treated, lot iden- be exposed to a radiation source listed tification, scheduled process, evidence in paragraph (a)(3) of this section so as of compliance with the scheduled proc- to receive an absorbed dose in excess of ess, ionizing energy source, source cali- 2 milligrays. bration, dosimetry, dose distribution in the product, and the date of irradia- [42 FR 14635, Mar. 15, 1977, as amended at 48 tion. FR 46022, Oct. 11, 1983; 61 FR 14246, Apr. 1, 1996] (Approved by the Office of Management and Budget under control number 0910–0186) § 179.25 General provisions for food ir- [51 FR 13399, Apr. 18, 1986] radiation. For the purposes of § 179.26, current § 179.26 Ionizing radiation for the good manufacturing practice is defined treatment of food. to include the following restrictions: Ionizing radiation for treatment of (a) Any firm that treats foods with foods may be safely used under the fol- ionizing radiation shall comply with lowing conditions: the requirements of part 110 of this (a) Energy sources. Ionizing radiation chapter and other applicable regula- is limited to: tions. (1) Gamma rays from sealed units of (b) Food treated with ionizing radi- the radionuclides cobalt-60 or cesium- ation shall receive the minimum radi- 137. ation dose reasonably required to ac- (2) Electrons generated from machine complish its intended technical effect sources at energies not to exceed 10 and not more than the maximum dose million electron volts. specified by the applicable regulation (3) X-rays generated from machine for that use. sources at energies not to exceed 5 mil- (c) Packaging materials subjected to lion electron volts. irradiation incidental to the radiation (b) Limitations.
419
VerDate 06
Use Limitations Use Limitations
1. For control of Trichinella spiralis in Minimum dose 0.3 7. For the sterilization of frozen, pack- Minimum dose 44 pork carcasses or fresh, non-heat- kiloGray (kGy) aged meats used solely in the Na- kGy (4.4 Mrad). processed cuts of pork carcasses. (30 kilorad tional Aeronautics and Space Admin- Packaging mate- (krad)); maximum istration space flight programs. rials used need dose not to ex- not comply with ceed 1 kGy (100 § 179.25(c) pro- krad). vided that their 2. For growth and maturation inhibition Not to exceed 1 use is otherwise of fresh foods. kGy (100 krad). permitted by ap- 3. For disinfestation of arthropod pests Do. plicable regula- in food. tions in parts 174 4. For microbial disinfection of dry or Not to exceed 10 through 186 of dehydrated enzyme preparations (in- kGy (1 megarad this chapter. cluding immobilized enzymes). (Mrad)). 8. For control of foodborne pathogens Not to exceed 4.5 5. For microbial disinfection of the fol- Not to exceed 30 in, and extension of the shelf-life of, kGy maximum lowing dry or dehydrated aromatic kGy (3 Mrad). refrigerated or frozen, uncooked for refrigerated vegetable substances when used as products that are meat within the products; not to ingredients in small amounts solely meaning of 9 CFR 301.2(rr), meat exceed 7.0 kGy for flavoring or aroma: culinary herbs, byproducts within the meaning of 9 maximum for fro- seeds, spices, vegetable seasonings CFR 301.2(tt), or meat food products zen products. that are used to impart flavor but that within the meaning of 9 CFR are not either represented as, or ap- 301.2(uu), with or without nonfluid pear to be, a vegetable that is eaten seasoning, that are otherwise com- for its own sake, and blends of these posed solely of intact or ground aromatic vegetable substances. Tur- meat, meat byproducts, or both meat meric and paprika may also be irradi- and meat byproducts.. ated when they are to be used as color additives. The blends may con- tain sodium chloride and minor (c) Labeling. (1) The label and label- amounts of dry food ingredients ordi- ing of retail packages of foods irradi- narily used in such blends. ated in conformance with paragraph (b) 6. For control of food-borne pathogens Not to exceed 3 in fresh or frozen, uncooked poultry kGy (300 krad); of this section shall bear the following products that are: (1) Whole car- any packaging logo along with either the statement 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).
420
VerDate 06
‘‘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] ents required under § 101.4 of this chap- ter. As used in this provision, the term § 179.30 Radiofrequency radiation for ‘‘radiation disclosure statement’’ the heating of food, including means the written statement that dis- microwave frequencies. closes that a food has been inten- Radiofrequency radiation, including tionally subject to irradiation. microwave frequencies, may be safely (2) For irradiated foods not in pack- used for heating food under the fol- age form, the required logo and phrase lowing conditions: ‘‘Treated with radiation’’ or ‘‘Treated (a) The radiation source consists of by irradiation’’ shall be displayed to electronic equipment producing radio the purchaser with either (i) the label- waves with specific frequencies for this ing of the bulk container plainly in purpose authorized by the Federal view or (ii) a counter sign, card, or Communications Commission. other appropriate device bearing the (b) The radiation is used or intended information that the product has been for use in the production of heat in treated with radiation. As an alter- food wherever heat is necessary and ef- native, each item of food may be indi- fective in the treatment or processing vidually labeled. In either case, the in- of food. formation must be prominently and conspicuously displayed to purchasers. § 179.39 Ultraviolet radiation for the The labeling requirement applies only processing and treatment of food. to a food that has been irradiated, not Ultraviolet radiation for the proc- to a food that merely contains an irra- essing and treatment of food may be diated ingredient but that has not safely used under the following condi- itself been irradiated. tions: (3) For a food, any portion of which is (a) The radiation sources consist of irradiated in conformance with para- ultraviolet emission tubes designed to graph (b) of this section, the label and emit wavelengths within the range of labeling and invoices or bills of lading 2200–3000 Angstrom units with 90 per- shall bear either the statement ‘‘Treat- cent of the emission being the wave- ed with radiation—do not irradiate length 2537 Angstrom units. 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 ...... Irradiated with 2,200 to 3,000 A. emissions, without ozone Surface microorganism con- production: high fat-content food irradiated in vacuum or trol. in an inert atmosphere; intensity of radiation, 1 W (of 2,537 A. radiation) per 5 to 10 ft.2. Potable water ...... Irradiated with 2,200 to 3,000 A. emissions, without ozone Sterilization of water used in production; coefficient of absorption, 0.19 per cm or food production. less; flow rate, 100 gal/h per watt of 2,537 A. radiation; water depth, 1 cm or less; lamp-operating temperature, 36° to 46 °C.
§ 179.41 Pulsed light for the treatment (a) The radiation sources consist of of food. xenon flashlamps designed to emit Pulsed light may be safely used for broadband radiation consisting of treatment of foods under the following wavelengths covering the range of 200 conditions: to 1,100 nanometers (nm), and operated
421
VerDate 06
so that the pulse duration is no longer monomers: Acrylic acid, acrylonitrile, than 2 milliseconds (msec); itaconic acid, methyl acrylate, and (b) The treatment is used for surface methyl methacrylate. microorganism control; (5) Kraft paper prepared from un- (c) Foods treated with pulsed light bleached sulfate pulp to which rosin, shall receive the minimum treatment complying with § 178.3870 of this chap- reasonably required to accomplish the ter, and alum may be added. The kraft intended technical effect; and paper is used only as a container for (d) The total cumulative treatment flour and is irradiated with a dose not shall not exceed 12.0 Joules/square cen- exceeding 500 grays. 2 timeter (J/cm .) (6) Polyethylene terephthalate film [61 FR 42383, Aug. 15, 1996] prepared from the basic polymer as de- scribed in § 177.1630(e)(4)(i) and (ii) of Subpart C—Packaging Materials this chapter. The finished film may for Irradiated Foods contain: (i) Adjuvant substances used in com- § 179.45 Packaging materials for use pliance with §§ 178.3740 and 181.22 during the irradiation of pre- through 181.30 of this chapter, sodium packaged foods. citrate, sodium lauryl sulfate, poly- The packaging materials identified vinyl chloride, and materials as listed in this section may be safely subjected in paragraph (d)(2)(i) of this section. to irradiation incidental to the radi- (ii) Coatings comprising a vinylidene ation treatment and processing of pre- chloride copolymer containing a min- packaged foods, subject to the provi- imum of 85 percent vinylidene chloride sions of this section and to the require- with one or more of the following co- ment that no induced radioactivity is monomers: Acrylic acid, acrylonitrile, detectable in the packaging material itaconic acid, methyl acrylate, and itself: methyl methacrylate. (a) The radiation of the food itself (iii) Coatings consisting of poly- shall comply with regulations in this ethylene conforming to § 177.1520 of this part. chapter. (b) The following packaging mate- 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 radiation in the radi- used in compliance with §§ 178.3740 and ation treatment of prepackaged foods: 181.22 through 181.30 of this chapter. (1) Nitrocellulose-coated or vinyli- (8) Rubber hydrochloride film pre- dene chloride copolymer-coated cello- pared from rubber hydrochloride basic phane complying with § 177.1200 of this polymer having a chlorine content of chapter. 30–32 weight percent and having a max- (2) Glassine paper complying with imum extractable fraction of 2 weight § 176.170 of this chapter. percent when extracted with n-hexane (3) Wax-coated paperboard complying at reflux temperature for 2 hours. The with § 176.170 of this chapter. finished film may contain adjuvant (4) Polyolefin film prepared from one substances used in compliance with or more of the basic olefin polymers §§ 178.3740 and 181.22 through 181.30 of complying with § 177.1520 of this chap- this chapter. ter. The finished film may contain: (9) Vinylidene chloride-vinyl chloride (i) Adjuvant substances used in com- copolymer film prepared from vinyli- pliance with §§ 178.3740 and 181.22 dene chloride-vinyl chloride basic co- through 181.30 of this chapter, sodium polymers containing not less than 70 citrate, sodium lauryl sulfate, poly- weight percent of vinylidene chloride vinyl chloride, and materials as listed and having a viscosity of 0.50–1.50 cen- in paragraph (d)(2)(i) of this section. tipoises as determined by ASTM meth- (ii) Coatings comprising a vinylidene od D729–81, ‘‘Standard Specification for chloride copolymer containing a min- Vinylidene Chloride Molding Com- imum of 85 percent vinylidene chloride pounds,’’ which is incorporated by ref- with one or more of the following co- erence. Copies may be obtained from
422
VerDate 06
the American Society for Testing Ma- (d) The following packaging mate- terials, 1916 Race St., Philadelphia, PA rials may be subjected to a dose of ra- 19103, or may be examined at the Office diation, not to exceed 60 kilograys inci- of the Federal Register, 800 North Cap- dental to the use of gamma or X-radi- itol Street, NW., suite 700, Washington, ation in the radiation processing of DC 20408. The finished film may con- prepackaged foods: tain adjuvant substances used in com- (1) Vegetable parchments, consisting pliance with §§ 178.3740 and 181.22 of a cellulose material made from through 181.30 of this chapter. waterleaf paper (unsized) treated with (10) Nylon 11 conforming to § 177.1500 concentrated sulfuric acid, neutralized, of this chapter. and thoroughly washed with distilled (c) Ethylene-vinyl acetate copoly- water. mers complying with § 177.1350 of this (2) Films prepared from basic poly- chapter. The ethylene-vinyl acetate mers and with or without adjuvants, as packaging materials may be subjected follows: to a dose of radiation, not to exceed 30 (i) Polyethylene film prepared from kilogray (3 megarads), incidental to the basic polymer as described in the use of gamma, electron beam, or X- § 177.1520(a) of this chapter. The fin- radiation in the radiation treatment of ished film may contain one or more of packaged foods. 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 and viscosity not less than 0.30 deter- prepared from the basic polymer as de- mined by ASTM method D1243–79, scribed in § 177.1630(e)(4)(ii) of this ‘‘Standard Test Method for Dilute So- chapter. The finished film may contain lution Viscosity of Vinyl Chloride one or more of the added substances Polymers,’’ Method A, which is incor- listed in paragraph (d)(2)(i) of this sec- porated by reference. The availability tion. of this incorporation by reference is (iii) Nylon 6 films prepared from the given in paragraph (b)(9) of this sec- nylon 6 basic polymer as described in tion. The finished film may contain § 177.1500(a)(6) of this chapter and meet- one or more of the added substances ing the specifications of item 6.1 of the listed in paragraph (d)(2)(i) of this sec- table in § 177.1500(b) of this chapter. tion. The finished film may contain one or more of the added substances listed in (e) Acrylonitrile copolymers identi- paragraph (d)(2)(i) of this section. fied in this section shall comply with (iv) Vinyl chloride-vinyl acetate co- the provisions of § 180.22 of this chap- polymer film prepared from the basic ter. copolymer containing 88.5 to 90.0 [42 FR 14635, Mar. 15, 1977, as amended at 49 weight percent of vinyl chloride with FR 10113, Mar. 19, 1984; 54 FR 7405, Feb. 21, 10.0 to 11.5 weight percent of vinyl ace- 1989; 54 FR 24899, June 12, 1989; 59 FR 14551, tate and having a maximum volatility Mar. 29, 1994; 61 FR 14246, Apr. 1, 1996] of not over 3.0 percent (1 hour at 105 °C)
423
VerDate 06
PART 180—FOOD ADDITIVES PER- mulgating an interim food additive MITTED IN FOOD OR IN CON- regulation shall provide that continued TACT WITH FOOD ON AN IN- use of the substance in food is subject 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. is harmful or that continued use of the (5) [Reserved] substance will result in harm to the (6) If clinical investigations involving public health. human subjects are involved, such in- (c) The Commissioner, on his own ini- vestigations filed with the Commis- tiative or on the petition of any inter- sioner shall include, with respect to ested person, pursuant to part 10 of this each investigation, a statement that chapter, may propose an interim food the investigation either was conducted additive regulation. A final order pro- in compliance with the requirements
424
VerDate 06
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 incorporated by reference. Copies are organizations, or other experts in the available from the Center for Food field, in evaluating: Safety and Applied Nutrition (HFS– (1) Whether an interim food additive 200), Food and Drug Administration, regulation is justified, 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 having a volume to surface ratio of less ditive, pending the issuance of a final than 10 milliliters per square inch of interim food additive regulation. Such food contact surface—0.3 part per mil- an action level shall be issued pursuant lion calculated on the basis of the vol- to sections 306 and 402(a) of the act to ume of the container when extracted to identify, based upon available data, a equilibrium at 120 °F with food-simu- safe level of use for the substance. lating solvents appropriate to the in- Such an action level shall be issued in tended conditions of use. a notice published in the FEDERAL REG- (3) In the case of repeated-use arti- ISTER and shall be followed as soon as cles—0.003 milligram/square inch when practicable by a proposed interim food extracted at a time equivalent to ini- additive regulation. Where the avail- tial batch usage utilizing food-simu- able data do not permit establishing an lating solvents and temperatures ap- action level for the safe use of a sub- propriate to the intended conditions of stance, use of the substance may be use. prohibited. The identification of a pro- The food-simulating solvents shall in- hibited substance may be made in part clude, where applicable, distilled 189 of this chapter when appropriate. water, 8 percent or 50 percent ethanol, [42 FR 14636, Mar. 15, 1977, as amended at 42 3 percent acetic acid, and either n- FR 15674, Mar. 22, 1977; 42 FR 52821, Sept. 30, heptane or an appropriate oil or fat. 1977; 46 FR 8952, Jan. 27, 1981; 46 FR 14340, (b) Where necessary, current regula- Feb. 27, 1981; 50 FR 7492, Feb. 22, 1985; 54 FR tions permitting the use of acrylo- 39634, Sept. 27, 1989] nitrile copolymers shall be revised to
425
VerDate 06
specify limitations on acrylonitrile/ and temperatures appropriate to the mercaptan complexes utilized in the intended conditions of use. production of acrylonitrile copolymers. (3) Data on the volume and/or weight Such copolymers, if they contain re- of food handled during the initial batch versible acrylonitrile/mercaptan com- time period(s), during the equilibrium plexes and are used in other than re- test period, and over the estimated life peated-use conditions, shall be tested of the food-contact surface. to determine the identity of the com- (d) Where acrylonitrile copolymers plex and the level of the complex represent only a minor component of a present in the food-contact article. polymer system, calculations based on Such testing shall include determina- 100 percent migration of the acrylo- tion of the rate of decomposition of the nitrile component may be submitted in complex at temperatures of 100 °F, 160 lieu of the requirements of paragraphs °F, and 212 °F using 3 percent acetic (a), (b), and (c) of this section in sup- acid as the hydrolic agent. Acrylo- port of the continued safe use of acry- nitrile monomer levels, acrylonitrile/ lonitrile copolymers. mercaptan complex levels, acrylo- (e) On or before September 13, 1976, nitrile oligomer levels, descriptions of any interested person shall satisfy the the analytical methods used to deter- Commissioner of Food and Drugs that mine the complex and the acrylonitrile toxicological feeding studies adequate migration, and validation studies of and appropriate to establish safe condi- these analytical methods shall be sub- tions for the use of acrylonitrile co- mitted by June 9, 1977, to the Center polymers have been, or soon will be, for Food Safety and Applied Nutrition undertaken. Toxicity studies of acrylo- (HFS–200), Food and Drug Administra- nitrile monomer shall include: (1) Life- tion, 200 C St. SW., Washington, DC time feeding studies with a mamma- 20204, unless an extension is granted by lian species, preferably with animals the Food and Drug Administration for exposed in utero to the chemical, (2) good cause shown. Analytical methods studies of multigeneration reproduc- 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 (1) Qualitative and quantitative mi- other uses of acrylonitrile copolymers gration values at a time equivalent to in use prior to June 14, 1976, may con- initial batch usage, utilizing solvents tinue under the following conditions: and temperatures appropriate to the (1) On or before August 13, 1976, each intended conditions of use. use of acrylonitrile copolymers in a (2) Qualitative and quantitative mi- manner not authorized by § 181.32 of gration values at the time of equi- this chapter or parts 174 through 179 of librium extractions, utilizing solvents this chapter shall be the subject of a
426
VerDate 06
notice to the Center for Food Safety (2) The fermentation of sugars or and Applied Nutrition (HFS–200), Food sugar alcohols such as glucose, sucrose, and Drug Administration, 200 C St. fructose, or sorbitol using the yeast SW., Washington, DC 20204. Such notice Zygosaccharomyces rouxii. shall be accompanied by a statement of (b) The ingredient meets the speci- the basis, including any articles and fications of the ‘‘Food Chemicals correspondence, on which the user in Codex,’’ 3d Ed. (1981), pp. 188–190, which good faith believed the use to be prior- is incorporated by reference. Copies sanctioned. The Commissioner of Food may be obtained from the National and Drugs shall, by notice in the FED- Academy Press, 2101 Constitution Ave. ERAL REGISTER, identify any use of ac- NW., Washington, DC 20418, or may be 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- standardized jams and jellies, commer- [42 FR 14636, Mar. 15, 1977, as amended at 47 cial, as defined in § 170.3(n)(28) of this FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, chapter, and at levels less than 2.5 per- 1989; 61 FR 14246, Apr. 1, 1996] cent in all other foods. (e) The label and labeling of food § 180.25 Mannitol. whose reasonably foreseeable consump- (a) Mannitol is the chemical tion may result in a daily ingestion of 1,2,3,4,5,6,-hexanehexol (C6H14O6) a 20 grams of mannitol shall bear the hexahydric alcohol, differing from sor- statement ‘‘Excess consumption may bitol principally by having a different have a laxative effect’’. optical rotation. Mannitol is produced (f) In accordance with § 180.1, ade- by one of the following processes: quate and appropriate feeding studies (1) The electrolytic reduction or have been undertaken for this sub- transition metal catalytic hydro- stance. Continued uses of this ingre- genation of sugar solutions containing dient are contingent upon timely and glucose or fructose. adequate progress reports of such tests,
427
VerDate 06
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, special dietary foods, as follows: NW., suite 700, Washington, DC 20418. (1) In beverages, fruit juice drinks, (b) The additive is used on an interim and bases or mixes when prepared for basis as a stabilizer for flavoring oils consumption in accordance with direc- used in fruit-flavored beverages, for tions, in amounts not to exceed 12 mil- which any applicable standards of iden- ligrams of the additive, calculated as tity do not preclude such use, in an saccharin, per fluid ounce. amount not to exceed 15 parts per mil- (2) As a sugar substitute for cooking lion in the finished beverage, pending or table use, in amounts not to exceed the outcome of additional toxicological 20 milligrams of the additive, cal- studies on which periodic reports at 6- culated as saccharin, for each ex- month intervals are to be furnished pressed teaspoonful of sugar sweet- and final results submitted to the Food ening equivalency. and Drug Administration promptly 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 calculated as saccharin, per serving of FR 5610, Feb. 14, 1984] 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. ance with the following conditions, if (2) To retain flavor and physical the substitution for nutritive sweet- properties of chewing gum. eners is for a valid special dietary pur- (3) To enhance flavor of flavor chips pose and is in accord with current spe- used in nonstandardized bakery prod- cial dietary food regulations and poli- ucts. cies or if the use or intended use is for (f) To assure safe use of the additives, an authorized technological purpose in addition to the other information re- other than calorie reduction: quired by the Act:
428
VerDate 06
(1) The label of the additive and any 181.34 Sodium nitrite and potassium nitrite. intermediate mixes of the additive for AUTHORITY: 21 U.S.C. 321, 342, 348, 371. manufacturing purposes shall bear: (i) The name of the additive. SOURCE: 42 FR 14638, Mar. 15, 1977, unless otherwise noted. (ii) A statement of the concentration of the additive, expressed as saccharin, EDITORIAL NOTE: Nomenclature changes to in any intermediate mix. part 181 appear at 61 FR 14482, Apr. 2, 1996. (iii) Adequate directions for use to provide a final food product that com- Subpart A—General Provisions plies with the limitations prescribed in paragraphs (d) and (e) of this section. § 181.1 General. (2) The label of any finished food (a) An ingredient whose use in food product containing the additive shall or food packaging is subject to a prior bear: sanction or approval within the mean- (i) The name of the additive. ing of section 201(s)(4) of the Act is ex- (ii) The amount of the additive, cal- empt from classification as a food addi- culated as saccharin, as follows: tive. The Commissioner will publish in (a) For beverages, in milligrams per this part all known prior sanctions. fluid ounce; Any interested person may submit to (b) For cooking or table use products, the Commissioner a request for publi- in milligrams per dispensing unit; cation of a prior sanction, supported by (c) For processed foods, in terms of evidence to show that it falls within the weight or size of a serving which section 201(s)(4) of the Act. shall be that quantity of the food con- (b) Based upon scientific data or in- taining 30 milligrams or less of the ad- formation that shows that use of a ditive. prior-sanctioned food ingredient may (iii) When the additive is used for cal- be injurious to health, and thus in vio- orie reduction, such other labeling as is lation of section 402 of the Act, the required by part 105 or § 100.130 of this Commissioner will establish or amend chapter. an applicable prior sanction regulation [42 FR 14636, Mar. 15, 1977, as amended at 49 to impose whatever limitations or con- FR 5610, Feb. 14, 1984] ditions are necessary for the safe use of the ingredient, or to prohibit use of the ingredient. PART 181—PRIOR-SANCTIONED (c) Where appropriate, an emergency FOOD INGREDIENTS action level may be issued for a prior- sanctioned substance, pending the Subpart A—General Provisions issuance of a final regulation in ac- Sec. cordance with paragraph (b) of this sec- 181.1 General. tion. Such an action level shall be 181.5 Prior sanctions. issued pursuant to section 402(a) of the Act to identify, based upon available Subpart B—Specific Prior-Sanctioned Food data, conditions of use of the substance Ingredients that may be injurious to health. Such 181.22 Certain substances employed in the an action level shall be issued in a no- manufacture of food-packaging mate- tice published in the FEDERAL REG- rials. ISTER and shall be followed as soon as 181.23 Antimycotics. practicable by a proposed regulation in 181.24 Antioxidants. accordance with paragraph (b) of this 181.25 Driers. 181.26 Drying oils as components of finished section. Where the available data dem- resins. onstrate that the substance may be in- 181.27 Plasticizers. jurious at any level, use of the sub- 181.28 Release agents. stance may be prohibited. The identi- 181.29 Stabilizers. fication of a prohibited substance may 181.30 Substances used in the manufacture be made in part 189 of this chapter of paper and paperboard products used in when appropriate. food packaging. 181.32 Acrylonitrile copolymers and resins. [42 FR 14638, Mar. 15, 1977, as amended at 42 181.33 Sodium nitrate and potassium ni- FR 52821, Sept. 30, 1977; 54 FR 39635, Sept. 27, trate. 1989]
429
VerDate 06
§ 181.5 Prior sanctions. at any later time. The notice will also (a) A prior sanction shall exist only constitute a proposal to establish a for a specific use(s) of a substance in regulation under this part, incor- food, i.e., the level(s), condition(s), porating the same provisions, in the product(s), etc., for which there was ex- event that such a regulation is deter- plicit approval by the Food and Drug mined to be appropriate as a result of Administration or the United States submission of proof of such an applica- Department of Agriculture prior to ble prior sanction in response to the September 6, 1958. proposal. (b) The existence of a prior sanction exempts the sanctioned use(s) from the Subpart B—Specific Prior- food additive provisions of the Act but Sanctioned Food Ingredients not from the other adulteration or the misbranding provisions of the Act. § 181.22 Certain substances employed (c) All known prior sanctions shall be in the manufacture of food-pack- the subject of a regulation published in aging materials. this part. Any such regulation is sub- ject to amendment to impose whatever Prior to the enactment of the food limitation(s) or condition(s) may be additives amendment to the Federal necessary for the safe use of the ingre- Food, Drug, and Cosmetic Act, sanc- dient, or revocation to prohibit use of tions were granted for the usage of the the ingredient, in order to prevent the substances listed in §§ 181.23, 181.24, adulteration of food in violation of sec- 181.25, 181.26, 181.27, 181.28, 181.29, and tion 402 of the Act. 181.30 in the manufacture of packaging (d) In proposing, after a general eval- materials. So used, these substances uation of use of an ingredient, regula- are not considered ‘‘food additives’’ tions affirming the GRAS status of within the meaning of section 201(s) of substances added directly to human the Act, provided that they are of good food in part 184 of this chapter or sub- commercial grade, are suitable for as- stances in food-contact surfaces in part sociation with food, and are used in ac- 186 of this chapter, or establishing a cordance with good manufacturing food additive regulation for substances practice. For the purpose of this sub- added directly to human food in parts part, good manufacturing practice for 172 and 173 of this chapter or food addi- food-packaging materials includes the tives in food-contact surfaces in parts restriction that the quantity of any of 174, 175, 176, 177, 178 and § 179.45 of this these substances which becomes a com- chapter, the Commissioner shall, if he ponent of food as a result of use in is aware of any prior sanction for use food-packaging materials shall not be of the ingredient under conditions dif- intended to accomplish any physical or ferent from those proposed in the regu- technical effect in the food itself, shall lation, concurrently propose a separate be reduced to the least amount reason- regulation covering such use of the in- ably possible, and shall not exceed any gredient under this part. If the Com- limit specified in this subpart. missioner is unaware of any such appli- cable prior sanction, the proposed regu- [42 FR 56728, Oct. 28, 1977] lation will so state and will require any person who intends to assert or rely on § 181.23 Antimycotics. such sanction to submit proof of its ex- Substances classified as istence. Any food additive or GRAS antimycotics, when migrating from regulation promulgated after a general food-packaging material shall include: evaluation of use of an ingredient con- stitutes a determination that excluded Calcium propionate. uses would result in adulteration of the Methylparaben (methyl p-hydroxybenzoate). food in violation of section 402 of the Propylparaben (propyl p-hydroxybenzoate). Act, and the failure of any person to Sodium benzoate. come forward with proof of such an ap- Sodium propionate. plicable prior sanction in response to a Sorbic acid. proposal will constitute a waiver of the [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. right to assert or rely on such sanction 28, 1977]
430
VerDate 06
§ 181.24 Antioxidants. Di-(2-ethylhexyl) phthalate (for foods of high water content only). Substances classified as antioxidants, Diethyl phthalate. when migrating from food-packaging Diisobutyl adipate. material (limit of addition to food, Diisooctyl phthalate (for foods of high water 0.005 percent) shall include: content only). Diphenyl-2-ethylhexyl phosphate. Butylated hydroxyanisole. Epoxidized soybean oil (iodine number max- Butylated hydroxytoluene. imum 6; and oxirane oxygen, minimum, 6.0 Dilauryl thiodipropionate. percent). Distearyl thiodipropionate. Ethylphthalyl ethyl glycolate. Gum guaiac. Glycerol monooleate. Nordihydroguairetic acid. Monoisopropyl citrate. Propyl gallate. Mono, di-, and tristearyl citrate. Thiodipropionic acid. 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 agents, when migrating from food- Cobalt caprylate. 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. Tall oil. Calcium phosphate. Calcium hydrogen phosphate. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. Calcium oleate. 28, 1977] Calcium acetate. Calcium carbonate. § 181.27 Plasticizers. Calcium ricinoleate. Substances classified as plasticizers, Calcium stearate. when migrating from food-packaging Disodium hydrogen phosphate. material shall include: Magnesium glycerophosphate. Magnesium stearate. Acetyl tributyl citrate. Magnesium phosphate. Acetyl triethyl citrate. Magnesium hydrogen phosphate. p-tert-Butylphenyl salicylate. Mono-, di-, and trisodium citrate. Butyl stearate. Mono-, di-, and tripotassium citrate. Butylphthalyl butyl glycolate. Potassium oleate. Dibutyl sebacate. Potassium stearate.
431
VerDate 06
Sodium pyrophosphate. Stearato-chromic chloride complex. Sodium stearate. Titanium dioxide.* Sodium tetrapyrophosphate. Urea formaldehyde polymer. Stannous stearate (not to exceed 50 parts per Vinylidine chlorides (polymerized). million tin as a migrant in finished food). Zinc orthophosphate (not to exceed 50 parts § 181.32 Acrylonitrile copolymers and per million zinc as a migrant in finished resins. food). (a) Acrylonitrile copolymers and res- Zinc resinate (not to exceed 50 parts per mil- lion zinc as a migrant in finished food). ins listed in this section, containing less than 30 percent acrylonitrile and [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. complying with the requirements of 28, 1977] paragraph (b) of this section, may be § 181.30 Substances used in the manu- safely used as follows: facture of paper and paperboard (1) Films. (i) Acrylonitrile/butadiene/ products used in food packaging. styrene copolymers—no restrictions. Substances used in the manufacture (ii) Acrylonitrile/butadiene copoly- of paper and paperboard products used mers—no restrictions. in food packaging shall include: (iii) Acrylonitrile/butadiene copoly- mer blended with vinyl chloride-vinyl Aliphatic polyoxyethylene ethers.* acetate (optional at level up to 5 per- 1-Alkyl (C6-C18)3-amino-3-aminopropane cent by weight of the vinyl chloride monoacetate.* resin) resin—for use only in contact Borax or boric acid for use in adhesives, sizes, and coatings.* with oleomargarine. Butadiene-styrene copolymer. (iv) Acrylonitrile/styrene copoly- Chromium complex of perfluoro-octane mer—no restrictions. sulfonyl glycine for use on paper and pa- (2) Coatings. (i) Acrylonitrile/buta- perboard which is waxed.* diene copolymer blended with poly- Disodium cyanodithioimidocarbamate with vinyl chloride resins—for use only on ethylene diamine and potassium N-methyl paper and paperboard in contact with dithiocarbamate and/or sodium 2- meats and lard. mercaptobenzothiazole (slimicides).* Ethyl acrylate and methyl methacrylate co- (ii) Polyvinyl chloride resin blended polymers of itaconic acid or methacrylic with either acrylonitrile/butadiene co- acid for use only on paper and paperboard polymer or acrylonitrile/butadiene sty- which is waxed.* rene copolymer mixed with neoprene, Hexamethylene tetramine as a setting agent for use as components of conveyor for protein, including casein.* belts to be used with fresh fruits, vege- 1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2-alkyl tables, and fish. (C6-C17) imidazolinium chloride.* (iii) Acrylonitrile/butadiene/styrene Itaconic acid (polymerized). Melamine formaldehyde polymer. copolymer—no restrictions. Methyl acrylate (polymerized). (iv) Acrylonitrile/styrene copoly- Methyl ethers of mono-, di-, and tripropylene mer—no restrictions. glycol.* (3) Rigid and semirigid containers. (i) Myristo chromic chloride complex. Acrylonitrile/butadiene/styrene copoly- Nitrocellulose. mer—for use only as piping for han- Polyethylene glycol 400. dling food products and for repeated- Polyvinyl acetate. Potassium pentachlorophenate as a slime use articles intended to contact food. control agent.* (ii) Acrylonitrile/styrene resin—no Potassium trichlorophenate as a slime con- restrictions. trol agent.* (iii) Acrylonitrile/butadiene copoly- Resins from high and low viscosity polyvinyl mer blended with polyvinyl chloride alcohol for fatty foods only. resin—for use only as extruded pipe. Rubber hydrochloride. (b) Limitations for acrylonitrile Sodium pentachlorophenate as a slime con- monomer extraction for finished food- trol agent.* Sodium-trichlorophenate as a slime control contact articles, determined by using agent.* the method of analysis titled ‘‘Gas- Solid Chromatographic Procedure for *Under the conditions of normal use, these Determining Acrylonitrile Monomer in substances would not reasonably be expected Acrylonitrile-Containing Polymers and to migrate to food, based on available sci- Food-Simulating Solvents,’’ which is entific information and data. incorporated by reference. Copies are
432
VerDate 06
available from the Center for Food meat products and cured poultry prod- Safety and Applied Nutrition (HFS– ucts. 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 solvents appropriate to the intended [48 FR 1705, Jan. 14, 1983] 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- ume of the container when extracted to Sec. ° 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) lating solvents and temperatures ap- used in conjunction with spices, 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. article containing acrylonitrile copoly- mers or resins that yield acrylonitrile Subpart B—Multiple Purpose GRAS Food monomer in excess of that amount pro- Substances vided for in paragraph (b) of this sec- 182.1045 Glutamic acid. tion shall be deemed to be adulterated 182.1047 Glutamic acid hydrochloride. in violation of section 402 of the Act. 182.1057 Hydrochloric acid. 182.1073 Phosphoric acid. [42 FR 14638, Mar. 15, 1977, as amended at 47 182.1087 Sodium acid pyrophosphate. FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, 182.1125 Aluminum sulfate. 1989] 182.1127 Aluminum ammonium sulfate. 182.1129 Aluminum potassium sulfate. § 181.33 Sodium nitrate and potassium 182.1131 Aluminum sodium sulfate. nitrate. 182.1180 Caffeine. Sodium nitrate and potassium ni- 182.1217 Calcium phosphate. trate are subject to prior sanctions 182.1235 Caramel. 182.1320 Glycerin. issued by the U.S. Department of Agri- 182.1480 Methylcellulose. culture for use as sources of nitrite, 182.1500 Monoammonium glutamate. with or without sodium or potassium 182.1516 Monopotassium glutamate. nitrite, in the production of cured red 182.1711 Silica aerogel.
433
VerDate 06
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. 182.3189 Calcium ascorbate. as safe for their intended use. However, 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. 182.3766 Sodium metabisulfite. stances that, when used for the pur- 182.3795 Sodium sorbate. poses indicated, in accordance with 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. Subpart E—Emulsifying Agents [Reserved] (b) For the purposes of this section, good manufacturing practice shall be Subpart F—Dietary Supplements defined to include the following re- [Reserved] strictions: Subpart G—Sequestrants (1) The quantity of a substance added to food does not exceed the amount 182.6085 Sodium acid phosphate. reasonably required to accomplish its 182.6197 Calcium diacetate. intended physical, nutritional, or other 182.6203 Calcium hexametaphosphate. technical effect in food; and 182.6215 Monobasic calcium phosphate. 182.6285 Dipotassium phosphate. (2) The quantity of a substance that 182.6290 Disodium phosphate. becomes a component of food as a re- 182.6757 Sodium gluconate. sult of its use in the manufacturing, 182.6760 Sodium hexametaphosphate. processing, or packaging of food, and 182.6769 Sodium metaphosphate. which is not intended to accomplish 182.6778 Sodium phosphate. any physical or other technical effect 182.6787 Sodium pyrophosphate. in the food itself, shall be reduced to 182.6789 Tetra sodium pyrophosphate. the extent reasonably possible. 182.6810 Sodium tripolyphosphate. (3) The substance is of appropriate Subpart H—Stabilizers food grade and is prepared and handled as a food ingredient. Upon request the 182.7255 Chondrus extract. Commissioner will offer an opinion, based on specifications and intended Subpart I—Nutrients use, as to whether or not a particular 182.8013 Ascorbic acid. grade or lot of the substance is of suit- 182.8159 Biotin. able purity for use in food and would
434
VerDate 06
generally be regarded as safe for the 186 of this chapter; ‘‘food additive regu- purpose intended, by experts qualified lation’’ under parts 170 through 180 of to evaluate its safety. this chapter; ‘‘interim food additive (c) The inclusion of substances in the regulation’’ under part 180 of this chap- list of nutrients does not constitute a ter; or ‘‘prohibited from use in food’’ finding on the part of the Department under part 189 of this chapter. that the substance is useful as a sup- plement to the diet for humans. [42 FR 14640, Mar. 15, 1977, as amended at 53 (d) Substances that are generally rec- FR 44875, Nov. 7, 1988] ognized as safe for their intended use within the meaning of section 409 of § 182.10 Spices and other natural seasonings and flavorings. the act are listed in this part. When the status of a substance has been re- Spices and other natural seasonings evaluated, it will be deleted from this and flavorings that are generally rec- part, and will be issued as a new regu- ognized as safe for their intended use, lation under the appropriate part, e.g., within the meaning of section 409 of ‘‘affirmed as GRAS’’ under part 184 or 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. 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.
435
VerDate 06
Common name Botanical name of plant source
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. 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.
436
VerDate 06
Common name Botanical name of plant source
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. 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.
437
VerDate 06
Common name Botanical name of plant source
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. 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]
438
VerDate 06
§ 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 Methyl anthranilate (methyl-2- and adjuvants. aminobenzoate). Piperonal (3,4-methylenedioxy-benzaldehyde, Synthetic flavoring substances and heliotropin). adjuvants that are generally recog- Vanillin. nized as safe for their intended use, [42 FR 14640, Mar. 15, 1977, as amended at 43 within the meaning of section 409 of FR 47724, Oct. 17, 1978; 44 FR 3963, Jan. 19, the Act, are as follows: 1979; 44 FR 20656, Apr. 6, 1979; 48 FR 51907, Nov. 15, 1983; 54 FR 7402, Feb. 21, 1989] Acetaldehyde (ethanal). Acetoin (acetyl methylcarbinol). Anethole (parapropenyl anisole). § 182.70 Substances migrating from Benzaldehyde (benzoic aldehyde). cotton and cotton fabrics used in N-Butyric acid (butanoic acid). dry food packaging. d- or l-Carvone (carvol). Substances migrating to food from Cinnamaldehyde (cinnamic aldehyde). cotton and cotton fabrics used in dry Citral (2,6-dimethyloctadien-2,6-al-8, gera- food packaging that are generally rec- nial, neral). ognized as safe for their intended use, Decanal (N-decylaldehyde, capraldehyde, within the meaning of section 409 of capric aldehyde, caprinaldehyde, aldehyde C-10). the Act, are as follows: Ethyl acetate. Beef tallow. Ethyl butyrate. Carboxymethylcellulose. 3-Methyl-3-phenyl glycidic acid ethyl ester Coconut oil, refined. (ethyl-methyl-phenyl-glycidate, so-called Cornstarch. strawberry aldehyde, C-16 aldehyde). Gelatin. Ethyl vanillin. Lard. Geraniol (3,7-dimethyl-2,6 and 3,6-octadien-1- Lard oil. ol). Oleic acid. Geranyl acetate (geraniol acetate). Peanut oil. Limonene (d-, l-, and dl-). Potato starch. Linalool (linalol, 3,7-dimethyl-1,6-octadien-3- Sodium acetate. ol). Sodium chloride. Linalyl acetate (bergamol). Sodium silicate.
439
VerDate 06
Sodium tripolyphosphate. § 182.99 Adjuvants for pesticide chemi- Soybean oil (hydrogenated). cals. Talc. Tallow (hydrogenated). Adjuvants, identified and used in ac- Tallow flakes. cordance with 40 CFR 180.1001 (c) and Tapioca starch. (d), which are added to pesticide use di- Tetrasodium pyrophosphate. lutions by a grower or applicator prior Wheat starch. to application to the raw agricultural Zinc chloride. commodity, are exempt from the re- [42 FR 14640, Mar. 15, 1977, as amended at 43 quirement of tolerances under section FR 11698, Mar. 21, 1978; 44 FR 28323, May 15, 409 of the Act. 1979; 45 FR 6085, Jan. 25, 1980; 47 FR 27807, 27814, June 25, 1982; 48 FR 51150, Nov. 7, 1983; 48 FR 51616, Nov. 10, 1983; 48 FR 51909, Nov. 15, Subpart B—Multiple Purpose GRAS 1983; 48 FR 52441, 52443, 52445, 52446, Nov. 18, Food Substances 1983; 51 FR 16830, May 7, 1986; 51 FR 27171, July 30, 1986; 60 FR 62208, Dec. 5, 1995] § 182.1045 Glutamic acid. § 182.90 Substances migrating to food (a) Product. Glutamic acid. from paper and paperboard prod- (b) [Reserved] ucts. (c) Limitations, restrictions, or expla- Substances migrating to food from nation. This substance is generally rec- paper and paperboard products used in ognized as safe when used as a salt sub- food packaging that are generally rec- stitute in accordance with good manu- ognized as safe for their intended use, facturing practice. within the meaning of section 409 of the Act, are as follows: § 182.1047 Glutamic acid hydro- chloride. Alum (double sulfate of aluminum and am- monium potassium, or sodium). (a) Product. Glutamic acid hydro- Aluminum hydroxide. chloride. Aluminum oleate. (b) [Reserved] Aluminum palmitate. (c) Limitations, restrictions, or expla- Casein. nation. This substance is generally rec- Cellulose acetate. ognized as safe when used as a salt sub- Cornstarch. Diatomaceous earth filler. stitute in accordance with good manu- Ethyl cellulose. facturing practice. Ethyl vanillin. Glycerin. § 182.1057 Hydrochloric acid. Oleic acid. (a) Product. Hydrochloric acid. Potassium sorbate. Silicon dioxides. (b) [Reserved] Sodium aluminate. (c) Limitations, restrictions, or expla- Sodium chloride. nation. This substance is generally rec- Sodium hexametaphosphate. ognized as safe when used as a buffer Sodium hydrosulfite. and neutralizing agent in accordance Sodium phosphoaluminate. with good manufacturing practice. Sodium silicate. Sodium sorbate. § 182.1073 Phosphoric acid. Sodium tripolyphosphate. Sorbitol. (a) Product. Phosphoric acid. Soy protein, isolated. (b) Conditions of use. This substance Starch, acid modified. is generally recognized as safe when Starch, pregelatinized. used in accordance with good manufac- Starch, unmodified. Talc. turing practice. Vanillin. Zinc hydrosulfite. § 182.1087 Sodium acid pyrophosphate. Zinc sulfate. (a) Product. Sodium acid [42 FR 14640, Mar. 15, 1977] pyrophosphate.
EDITORIAL NOTE: For additional FEDERAL (b) Conditions of use. This substance REGISTER citations affecting § 182.90, see the is generally recognized as safe when List of CFR Sections Affected in the Finding used in accordance with good manufac- Aids section of this volume. turing practice.
440
VerDate 06
§ 182.1125 Aluminum sulfate. § 182.1320 Glycerin. (a) Product. Aluminum sulfate. (a) Product. Glycerin. (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.
§ 182.1127 Aluminum ammonium sul- § 182.1480 Methylcellulose. fate. (a) Product. U.S.P. methylcellulose, (a) Product. Aluminum ammonium except that the methoxy content shall sulfate. not be less than 27.5 percent and not (b) Conditions of use. This substance more than 31.5 percent on a dry-weight is generally recognized as safe when basis. 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- § 182.1129 Aluminum potassium sul- turing practice. fate. (a) Product. Aluminum potassium sul- § 182.1500 Monoammonium glutamate. fate. (a) Product. Monoammonium glu- (b) Conditions of use. This substance tamate. 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. § 182.1131 Aluminum sodium sulfate. § 182.1516 Monopotassium glutamate. (a) Product. Aluminum sodium sul- fate. (a) Product. Monopotassium glu- (b) Conditions of use. This substance tamate. 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. § 182.1180 Caffeine. § 182.1711 Silica aerogel. (a) Product. Caffeine. (b) Tolerance. 0.02 percent. (a) Product. Silica aerogel as a finely (c) Limitations, restrictions, or expla- powdered microcellular silica foam having a minimum silica content of nation. This substance is generally rec- 89.5 percent. ognized as safe when used in cola-type beverages in accordance with good (b) [Reserved] manufacturing practice. (c) Limitations, restrictions, or expla- nation. This substance is generally rec- § 182.1217 Calcium phosphate. ognized as safe when used as a compo- nent of an anti-foaming agent in ac- (a) Product. Calcium phosphate cordance with good manufacturing (mono-, di-, and tribasic). practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.1745 Sodium carboxymethylcellu- used in accordance with good manufac- lose. turing practice. (a) Product. Sodium carboxy- methylcellulose is the sodium salt of § 182.1235 Caramel. carboxymethylcellulose not less than (a) Product. Caramel. 99.5 percent on a dry-weight basis, with (b) Conditions of use. This substance maximum substitution of 0.95 is generally recognized as safe when carboxymethyl groups per used in accordance with good manufac- anhydroglucose unit, and with a min- turing practice. imum viscosity of 25 centipoises for 2
441
VerDate 06
percent by weight aqueous solution at percent in baking powder in accordance 25 °C. with good manufacturing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.2437 Magnesium silicate. used in accordance with good manufac- (a) Product. Magnesium silicate. turing practice. (b) Tolerance. 2 percent. (c) Limitations, restrictions, or expla- § 182.1748 Sodium caseinate. nation. This substance is generally rec- (a) Product. Sodium caseinate. ognized as safe when used in table salt (b) Conditions of use. This substance in accordance with good manufacturing is generally recognized as safe when practice. used in accordance with good manufac- turing practice. § 182.2727 Sodium aluminosilicate.
§ 182.1778 Sodium phosphate. (a) Product. Sodium aluminosilicate (sodium silicoaluminate). (a) Product. Sodium phosphate (b) Tolerance. This substance is gen- (mono-, di-, and tribasic). 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. § 182.2729 Sodium calcium § 182.1781 Sodium aluminum phos- aluminosilicate, hydrated. phate. (a) Product. Hydrated sodium calcium (a) Product. Sodium aluminum phos- aluminosilicate (sodium calcium phate. silicoaluminate). (b) This substance Conditions of use. (b) Tolerance. This substance is gen- is generally recognized as safe when erally recognized as safe for use at a used in accordance with good manufac- level not exceeding 2 percent in accord- turing practice. ance with good manufacturing prac- § 182.1810 Sodium tripolyphosphate. tice. (a) Product. Sodium § 182.2906 Tricalcium silicate. tripolyphosphate. (a) Product. Tricalcium silicate. (b) Conditions of use. This substance is generally recognized as safe when (b) Tolerance. 2 percent. 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 table salt in accordance with good manufacturing Subpart C—Anticaking Agents practice. § 182.2122 Aluminum calcium silicate. (a) Product. Aluminum calcium sili- Subpart D—Chemical cate. Preservatives (b) Tolerance. 2 percent. § 182.3013 Ascorbic acid. (c) Limitations, restrictions, or expla- nation. This substance is generally rec- (a) Product. Ascorbic acid. ognized as safe when used in table salt (b) Conditions of use. This substance in accordance with good manufacturing is generally recognized as safe when practice. used in accordance with good manufac- turing practice. § 182.2227 Calcium silicate. (a) Product. Calcium silicate. § 182.3041 Erythorbic acid. (b) Tolerance. 2 percent and 5 percent. (a) Product. Erythorbic acid. (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 at levels not used in accordance with good manufac- exceeding 2 percent in table salt and 5 turing practice.
442
VerDate 06
§ 182.3089 Sorbic acid. (b) Conditions of use. This substance (a) Product. Sorbic acid. 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- § 182.3280 Dilauryl thiodipropionate. turing practice. (a) Product. Dilauryl § 182.3109 Thiodipropionic acid. thiodipropionate. (a) Product. Thiodipropionic acid. (b) Tolerance. This substance is gen- (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 is not over 0.02 percent of fat or oil content, including essential (volatile) content, including essential (volatile) oil content of the food, provided the oil content of the food, provided the substance is used in accordance with substance is used in accordance with good manufacturing practice. good manufacturing practice. § 182.3616 Potassium bisulfite. § 182.3149 Ascorbyl palmitate. (a) Product. Potassium bisulfite. (a) Product. Ascorbyl palmitate. (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 § 182.3169 Butylated hydroxyanisole. meats; in food recognized as a source of (a) Product. Butylated hydroxy- vitamin B1; on fruits and vegetables in- anisole. tended to be served raw to consumers (b) Tolerance. This substance is gen- or sold raw to consumers, or to be pre- erally recognized as safe for use in food sented to consumers as fresh. when the total content of antioxidants is not over 0.02 percent of fat or oil [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, content, including essential (volatile) 1990; 59 FR 65939, Dec. 22, 1994] oil content of food, provided the sub- stance is used in accordance with good § 182.3637 Potassium metabisulfite. manufacturing practice. (a) Product. Potassium metabisulfite. § 182.3173 Butylated hydroxytoluene. (b) [Reserved] (a) Product. Butylated hydroxy- (c) Limitations, restrictions, or expla- toluene. nation. This substance is generally rec- (b) Tolerance. This substance is gen- ognized as safe when used in accord- erally recognized as safe for use in food ance with good manufacturing prac- when the total content of antioxidants tice, except that it is not used in is not over 0.02 percent of fat or oil meats; in food recognized as a source of content, including essential (volatile) vitamin B1; on fruits and vegetables in- oil content of food, provided the sub- tended to be served raw to consumers stance is used in accordance with good or sold raw to consumers, or to be pre- manufacturing practice. sented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 § 182.3189 Calcium ascorbate. FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, (a) Product. Calcium ascorbate. 1990; 59 FR 65939, Dec. 22, 1994] (b) Conditions of use. This substance is generally recognized as safe when § 182.3640 Potassium sorbate. used in accordance with good manufac- (a) Product. Potassium sorbate. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.3225 Calcium sorbate. used in accordance with good manufac- (a) Product. Calcium sorbate. turing practice.
443
VerDate 06
§ 182.3731 Sodium ascorbate. tended to be served raw to consumers (a) Product. Sodium ascorbate. 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 25026, July 9, 1986; 55 FR 9833, Mar. 15, turing practice. 1990; 59 FR 65939, Dec. 22, 1994]
§ 182.3739 Sodium bisulfite. § 182.3862 Sulfur dioxide. (a) Product. Sodium bisulfite. (a) Product. Sulfur dioxide. (b) [Reserved] (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 accord- ognized as safe when used in accord- ance with good manufacturing prac- ance with good manufacturing prac- tice, except that it is not used in tice, except that it is not used in meats; in food recognized as a source of meats; in food recognized as a source of vitamin B1; on fruits or vegetables in- vitamin B1; on fruits or vegetables in- tended to be served raw to consumers tended to be served raw to consumers or sold raw to consumers, or to be pre- or sold raw to consumers, or to be pre- sented to the consumer as fresh. sented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994] 1990; 59 FR 65939, Dec. 22, 1994]
§ 182.3766 Sodium metabisulfite. § 182.3890 Tocopherols. (a) Product. Sodium metabisulfite. (a) Product. Tocopherols. (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 Subpart E—Emulsifying Agents meats; in food recognized as a source of [Reserved] vitamin B1; on fruits or vegetables in- tended to be served raw to consumers or sold raw to consumers, or to be pre- Subpart F—Dietary Supplements sented to consumers as fresh. [Reserved]
[42 FR 14640, Mar. 15, 1977, as amended at 51 1 FR 25025, July 9, 1986; 55 FR 9833, Mar. 15, Subpart G—Sequestrants 1990; 59 FR 65939, Dec. 22, 1994] § 182.6085 Sodium acid phosphate. § 182.3795 Sodium sorbate. (a) Product. Sodium acid phosphate. (a) Product. Sodium sorbate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.6197 Calcium diacetate. § 182.3798 Sodium sulfite. (a) Product. Calcium diacetate. (a) Product. Sodium sulfite. (b) Conditions of use. This substance (b) [Reserved] is generally recognized as safe when (c) Limitations, restrictions, or expla- used in accordance with good manufac- nation. This substance is generally rec- turing practice. ognized as safe when used in accord- ance with good manufacturing prac- 1 For the purpose of this subpart, no at- tice, except that it is not used in tempt has been made to designate those meats; in food recognized as a source of sequestrants that may also function as vitamin B1; on fruits or vegetables in- chemical preservatives. 444
VerDate 06
§ 182.6203 Calcium (b) Conditions of use. This substance hexametaphosphate. is generally recognized as safe when (a) Product. Calcium used in accordance with good manufac- hexametaphosphate. turing practice. (b) Conditions of use. This substance § 182.6787 Sodium pyrophosphate. is generally recognized as safe when used in accordance with good manufac- (a) Product. Sodium pyrophosphate. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.6215 Monobasic calcium phos- used in accordance with good manufac- phate. turing practice. (a) Product. Monobasic calcium phos- phate. § 182.6789 Tetra sodium (b) Conditions of use. This substance pyrophosphate. is generally recognized as safe when (a) Product. Tetra sodium used in accordance with good manufac- pyrophosphate. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.6285 Dipotassium phosphate. used in accordance with good manufac- (a) Product. Dipotassium phosphate. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.6810 Sodium tripolyphosphate. used in accordance with good manufac- (a) Product. Sodium turing practice. tripolyphosphate. (b) Conditions of use. This substance § 182.6290 Disodium phosphate. is generally recognized as safe when (a) Product. Disodium phosphate. 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- Subpart H—Stabilizers turing practice. § 182.7255 Chondrus extract. § 182.6757 Sodium gluconate. (a) Product. Chondrus extract (a) Product. Sodium gluconate. (carrageenin). (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. § 182.6760 Sodium hexametaphosphate. Subpart I—Nutrients (a) Product. Sodium hexametaphosphate. 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 § 182.6769 Sodium metaphosphate. is generally recognized as safe when (a) Product. Sodium metaphosphate. 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 § 182.6778 Sodium phosphate. is generally recognized as safe when (a) Product. Sodium phosphate used in accordance with good manufac- (mono-, di-, and tribasic). turing practice.
445
VerDate 06
§ 182.8217 Calcium phosphate. § 182.8988 Zinc gluconate. (a) Product. Calcium phosphate (a) Product. Zinc gluconate. (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. § 182.8991 Zinc oxide. § 182.8223 Calcium pyrophosphate. (a) Product. Zinc oxide. (a) Product. Calcium 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. § 182.8994 Zinc stearate. § 182.8250 Choline bitartrate. (a) Product. Zinc stearate prepared (a) Product. Choline bitartrate. from stearic acid free from chickedema (b) Conditions of use. This substance factor. 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. § 182.8252 Choline chloride. § 182.8997 Zinc sulfate. (a) Product. Choline chloride. (b) Conditions of use. This substance (a) Product. Zinc sulfate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.8778 Sodium phosphate. (a) Product. Sodium phosphate PART 184—DIRECT FOOD SUB- (mono-, di-, and tribasic). STANCES AFFIRMED AS GEN- (b) Conditions of use. This substance ERALLY RECOGNIZED AS SAFE is generally recognized as safe when used in accordance with good manufac- Subpart A—General Provisions turing practice. Sec. 184.1 Substances added directly to human § 182.8890 Tocopherols. food affirmed as generally recognized as (a) Product. Tocopherols. safe (GRAS). (b) Conditions of use. This substance is generally recognized as safe when Subpart B—Listing of Specific Substances used in accordance with good manufac- Affirmed as GRAS turing practice. 184.1005 Acetic acid. 184.1007 Aconitic acid. § 182.8892 α-Tocopherol acetate. 184.1009 Adipic acid. (a) Product. α-Tocopherol acetate. 184.1011 Alginic acid. 184.1012 α-Amylase enzyme preparation (b) Conditions of use. This substance from Bacillus stearothermophilus. is generally recognized as safe when 184.1021 Benzoic acid. used in accordance with good manufac- 184.1024 Bromelain. turing practice. 184.1025 Caprylic acid. 184.1027 Mixed carbohydrase and protease § 182.8985 Zinc chloride. enzyme product. (a) Product. Zinc chloride. 184.1033 Citric acid. 184.1034 Catalase (bovine liver). (b) Conditions of use. This substance 184.1061 Lactic acid. is generally recognized as safe when 184.1063 Enzyme-modified lecithin. used in accordance with good manufac- 184.1065 Linoleic acid. turing practice. 184.1069 Malic acid.
446
VerDate 06
184.1077 Potassium acid tartrate. 184.1315 Ferrous sulfate. 184.1081 Propionic acid. 184.1316 Ficin. 184.1090 Stearic acid. 184.1317 Garlic and its derivatives. 184.1091 Succinic acid. 184.1318 Glucono delta-lactone. 184.1095 Sulfuric acid. 184.1321 Corn gluten. 184.1097 Tannic acid. 184.1322 Wheat gluten. 184.1099 Tartaric acid. 184.1323 Glyceryl monooleate. 184.1101 Diacetyl tartaric acid esters of 184.1324 Glyceryl monostearate. mono- and diglycerides. 184.1328 Glyceryl behenate. 184.1115 Agar-agar. 184.1329 Glyceryl palmitostearate. 184.1120 Brown algae. 184.1330 Acacia (gum arabic). 184.1121 Red algae. 184.1333 Gum ghatti. 184.1133 Ammonium alginate. 184.1339 Guar gum. 184.1135 Ammonium bicarbonate. 184.1343 Locust (carob) bean gum. 184.1137 Ammonium carbonate. 184.1349 Karaya gum (sterculia gum). 184.1138 Ammonium chloride. 184.1351 Gum tragacanth. 184.1139 Ammonium hydroxide. 184.1355 Helium. 184.1140 Ammonium citrate, dibasic. 184.1366 Hydrogen peroxide. 184.1141a Ammonium phosphate, monobasic. 184.1370 Inositol. 184.1141b Ammonium phosphate, dibasic. 184.1372 Insoluble glucose isomerase enzyme 184.1143 Ammonium sulfate. preparations. 184.1155 Bentonite. 184.1375 Iron, elemental. 184.1157 Benzoyl peroxide. 184.1386 Isopropyl citrate. 184.1165 n–Butane and iso–butane. 184.1387 Lactase enzyme preparation from 184.1185 Calcium acetate. Candida pseudotropicalis. 184.1187 Calcium alginate. 184.1388 Lactase enzyme preparation from 184.1191 Calcium carbonate. Kluyveromyces lactis. 184.1193 Calcium chloride. 184.1400 Lecithin. 184.1195 Calcium citrate. 184.1408 Licorice and licorice derivatives. 184.1199 Calcium gluconate. 184.1409 Ground limestone. 184.1201 Calcium glycerophosphate. 184.1415 Animal lipase. 184.1205 Calcium hydroxide. 184.1420 Lipase enzyme preparation derived 184.1206 Calcium iodate. from Rhizopus niveus. 184.1207 Calcium lactate. 184.1425 Magnesium carbonate. 184.1210 Calcium oxide. 184.1426 Magnesium chloride. 184.1212 Calcium pantothenate. 184.1428 Magnesium hydroxide. 184.1221 Calcium propionate. 184.1431 Magnesium oxide. 184.1229 Calcium stearate. 184.1434 Magnesium phosphate. 184.1230 Calcium sulfate. 184.1440 Magnesium stearate. 184.1240 Carbon dioxide. 184.1443 Magnesium sulfate. 184.1245 Beta-carotene. 184.1443a Malt. 184.1257 Clove and its derivatives. 184.1444 Maltodextrin. 184.1259 Cocoa butter substitute. 184.1445 Malt syrup (malt extract). 184.1260 Copper gluconate. 184.1446 Manganese chloride. 184.1261 Copper sulfate. 184.1449 Manganese citrate. 184.1262 Corn silk and corn silk extract. 184.1452 Manganese gluconate. 184.1265 Cuprous iodide. 184.1461 Manganese sulfate. 184.1271 L-Cysteine. 184.1472 Menhaden oil. 184.1272 L-Cysteine monohydrochloride. 184.1490 Methylparaben. 184.1277 Dextrin. 184.1498 Microparticulated protein product. 184.1278 Diacetyl. 184.1505 Mono- and diglycerides. 184.1282 Dill and its derivatives. 184.1521 Monosodium phosphate derivatives 184.1287 Enzyme-modified fats. of mono- and diglycerides. 184.1293 Ethyl alcohol. 184.1530 Niacin. 184.1295 Ethyl formate. 184.1535 Niacinamide. 184.1296 Ferric ammonium citrate. 184.1537 Nickel. 184.1297 Ferric chloride. 184.1538 Nisin preparation. 184.1298 Ferric citrate. 184.1540 Nitrogen. 184.1301 Ferric phosphate. 184.1545 Nitrous oxide. 184.1304 Ferric pyrophosphate. 184.1553 Peptones. 184.1307 Ferric sulfate. 184.1555 Rapeseed oil. 184.1307a Ferrous ascorbate. 184.1560 Ox bile extract. 184.1307b Ferrous carbonate. 184.1563 Ozone. 184.1307c Ferrous citrate. 184.1583 Pancreatin. 184.1307d Ferrous fumarate. 184.1585 Papain. 184.1308 Ferrous gluconate. 184.1588 Pectins. 184.1311 Ferrous lactate. 184.1595 Pepsin.
447
VerDate 06
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. 184.1635 Potassium iodate. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. 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. 184.1666 Propylene glycol. Subpart A—General Provisions 184.1670 Propylparaben. 184.1676 Pyridoxine hydrochloride. § 184.1 Substances added directly to 184.1685 Rennet (animal-derived) and human food affirmed as generally chymosin preparation (fermentation-de- recognized as safe (GRAS). 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. 184.1699 Oil of rue. tration and determined to be generally 184.1702 Sheanut oil. recognized as safe (GRAS) for the pur- 184.1721 Sodium acetate. poses and under the conditions pre- 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 184.1751 Sodium citrate. 184.1754 Sodium diacetate. as GRAS and to differentiate it from 184.1763 Sodium hydroxide. other possible versions of the ingre- 184.1764 Sodium hypophosphite. dient that have not been affirmed as 184.1768 Sodium lactate. GRAS. Ingredients affirmed as GRAS 184.1769a Sodium metasilicate. in this part are also GRAS as indirect 184.1784 Sodium propionate. human food ingredients, subject to any 184.1792 Sodium sesquicarbonate. limitations prescribed in parts 174, 175, 184.1801 Sodium tartrate. 184.1804 Sodium potassium tartrate. 176, 177, 178 or § 179.45 of this chapter or 184.1807 Sodium thiosulfate. in part 186 of this chapter. The purity 184.1835 Sorbitol. specifications in this part do not apply 184.1845 Stannous chloride (anhydrous and when the ingredient is used in indirect dihydrated). applications. However, when used in in- 184.1848 Starter distillate. direct applications, the ingredient 184.1851 Stearyl citrate must be of a purity suitable for its in- 184.1854 Sucrose. tended use in accordance with 184.1857 Corn sugar. 184.1859 Invert sugar. § 170.30(h)(1) of this chapter. 184.1865 Corn syrup. (b) Any ingredient affirmed as GRAS 184.1866 High fructose corn syrup. in this part shall be used in accordance 184.1875 Thiamine hydrochloride. with current good manufacturing prac- 184.1878 Thiamine mononitrate. tice. For the purpose of this part, cur- 184.1890 α-Tocopherols. rent good manufacturing practice in- 184.1901 Triacetin. cludes the requirements that a direct 184.1903 Tributyrin. 184.1911 Triethyl citrate. human food ingredient be of appro- 184.1914 Trypsin. priate food grade; that it be prepared 184.1923 Urea. and handled as a food ingredient; and 184.1924 Urease enzyme preparation from that the quantity of the ingredient Lactobacillus fermentum. added to food does not exceed the 184.1930 Vitamin A. amount reasonably required to accom- 184.1945 Vitamin B12. plish the intended physical, nutri- 184.1950 Vitamin D. tional, or other technical effect in 184.1973 Beeswax (yellow and white). 184.1976 Candelilla wax. food. 184.1978 Carnauba wax. (1) If the ingredient is affirmed as 184.1979 Whey. GRAS with no limitations on its condi- 184.1979a Reduced lactose whey. tions of use other than current good
448
VerDate 06
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 conditions of use, the agency will de- covering such use of the ingredient scribe in the regulation that affirms under part 181 of this chapter. If the the GRAS status of the ingredient, one Commissioner is unaware of any such or more of these limited conditions of applicable prior sanction, the proposed use, which may include the category of regulation will so state and will re- food(s), the technical effect(s) or func- quire any person who intends to assert tional use(s) of the ingredient, and the or rely on such sanction to submit level(s) of use. If the ingredient is used proof of its existence. Any regulation under conditions that are significantly promulgated pursuant to this section different from those described in the constitutes a determination that ex- regulation, that use of the ingredient cluded uses would result in adultera- may not be GRAS. In such a case, a tion of the food in violation of section manufacturer may not rely on the reg- 402 of the Act, and the failure of any ulation as authorizing that use but person to come forward with proof of shall independently establish that that such an applicable prior sanction in re- use is GRAS or shall use the ingredient sponse to the proposal will constitute a in accordance with a food additive reg- waiver of the right to assert or rely on ulation. Persons seeking FDA approval such sanction at any later time. The of an independent determination that a notice will also constitute a proposal use of an ingredient is GRAS may sub- to establish a regulation under part 181 mit a GRAS petition in accordance of this chapter, incorporating the same with § 170.35 of this chapter. provisions, in the event that such a (2) If the ingredient is affirmed as regulation is determined to be appro- GRAS with specific limitation(s), it shall be used in food only within such priate as a result of submission of proof limitation(s), including the category of of such an applicable prior sanction in food(s), the functional use(s) of the in- response to the proposal. gredient, and the level(s) of use. Any (f) The label and labeling of the in- use of such an ingredient not in full gredient and any intermediate mix of compliance with each such established the ingredient for use in finished food limitation shall require a food additive shall bear, in addition to the other la- regulation. beling required by the Act: (3) If the ingredient is affirmed as (1) The name of the ingredient, ex- GRAS for a specific use, without a gen- cept where exempted from such label- eral evaluation of use of the ingredient, ing in part 101 of this chapter. other uses may also be GRAS. (2) A statement of concentration of (c) The listing of a food ingredient in the ingredient in any intermediate this part does not authorize the use of mix; or other information to permit a such substance in a manner that may food processor independently to deter- lead to deception of the consumer or to mine that use of the ingredients will be any other violation of the Federal in accordance with any limitations and Food, Drug, and Cosmetic Act (the good manufacturing practice gudelines Act). prescribed. (d) The listing of more than one in- gredient to produce the same techno- logical effect does not authorize use of
449
VerDate 06
(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 § 170.3(n)(24) of this chapter; 0.6 percent [42 FR 14653, Mar. 15, 1977, as amended at 42 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 used in boiler water additives at levels Substances Affirmed as GRAS not to exceed current good manufac- § 184.1005 Acetic acid. turing practice. (e) Prior sanctions for this ingredient (a) Acetic acid (C2H4O2, CAS Reg. No. different from the uses established in 64–19–7) is known as ethanoic acid. It this section do not exist or have been occurs naturally in plant and animal waived. tissues. It is produced by fermentation of carbohydrates or by organic syn- [47 FR 27814, June 25, 1982] thesis. The principal synthetic meth- ods currently employed are oxidation § 184.1007 Aconitic acid. of acetaldehyde derived from ethylene, (a) Aconitic acid (1,2,3- liquid phase oxidation of butane, and propenetricarboxylic acid (C6H6O6), reaction of carbon monoxide with CAS Reg. No. 000499–12–7) occurs in the methanol derived from natural gas. leaves and tubers of Aconitum napellus (b) The ingredient meets the speci- L. and other Ranunculaceae. fications of the Food Chemicals Codex, Transaconitic acid can be isolated dur- 3d Ed. (1981), p. 8, which is incorporated ing sugarcane processing, by precipita- by reference. Copies are available from tion as the calcium salt from cane the National Academy Press, 2101 Con- sugar or molasses. It may be syn- stitution Ave. NW., Washington, DC thesized by sulfuric acid dehydration of 20418, or available for inspection at the citric acid, but not by the Office of the Federal Register, 800 methanesulfonic acid method. North Capitol Street, NW., suite 700, (b) The ingredient meets the fol- Washington, DC 20408. lowing specifications: (c) The ingredient is used as a curing (1) Assay. Not less than 98.0 percent and pickling agent as defined in of C3H3(COOH)3, using the ‘‘Food § 170.3(o)(5) of this chapter; flavor Chemicals Codex,’’ 4th ed. (1996), pp. enhancer as defined in § 170.3(o)(11) of 102–103, test for citric acid, which is in- this chapter; flavoring agent and adju- corporated by reference in accordance vant as defined in § 170.3(o)(12) of this with 5 U.S.C. 552(a) and 1 CFR part 51, chapter; pH control agent as defined in and a molecular weight of 174.11. Copies § 170.3(o)(23) of this chapter; as a sol- of the material incorporated by ref- vent and vehicle as defined in erence are available from the National § 170.3(o)(27) of this chapter; and as a Academy Press, Box 285, 2101 Constitu- boiler water additive complying with tion Ave. NW., Washington, DC 20055 § 173.310 of this chapter. (Internet address ‘‘http:// (d) The ingredient is used in food at www.nap.edu’’), or may be examined at levels not to exceed current good man- the Center for Food Safety and Applied ufacturing practice in accordance with Nutrition’s Library, Food and Drug Ad- § 184.1(b)(1). Current good manufac- ministration, 200 C St. SW., rm. 3321, turing practice results in a maximum Washington, DC, or at the Office of the level as served, of 0.25 percent for Federal Register, 800 North Capitol St. baked goods as defined in § 170.3(n)(1) of NW., suite 700, Washington, DC. this chapter; 0.8 percent for cheeses as (2) Melting point. Not less than 195 °C defined in § 170.3(n)(5) of this chapter and the determination results in de- and dairy product analogs as defined in composition of aconitic acid. § 170.3(n)(10) of this chapter; 0.5 percent (3) Heavy metals (as Pb). Not more for chewing gum as defined in than 10 parts per million. § 170.3(n)(6) of this chapter; 9.0 percent (4) Arsenic (as As). Not more than 3 for condiments and relishes as defined parts per million.
450
VerDate 06
(5) Oxalate. Passes test. oxidation of cyclohexanol or (6) Readily carbonizable substances. cyclohexanone or a mixture of the two. Passes the test for citric acid of the (b) The ingredient meets the speci- ‘‘Food Chemicals Codex,’’ 4th ed. (1996), fications of the Food Chemicals Codex, pp. 102–103, which is incorporated by 3d Ed. (1981), p. 11, which is incor- reference in accordance with 5 U.S.C. porated by reference (copies are avail- 552(a) and 1 CFR part 51. The avail- able from the National Academy Press, ability of this incorporation by ref- 2101 Constitution Ave., NW., Wash- erence is given in paragraph (b)(1) of ington, DC 20418, or available for in- this section. spection at the Office of the Federal (7) Residue on ignition. Not more than Register, 800 North Capitol Street, 0.1 percent as determined by the ‘‘Food NW., suite 700, Washington, DC 20408), Chemicals Codex,’’ 4th ed. (1996), pp. and the following additional specifica- 102–103, test for citric acid, which is in- tions: corporated by reference in accordance (1) The adipic acid is converted to its with 5 U.S.C. 552(a) and 1 CFR part 51. corresponding amide. The amide is pu- The availability of this incorporation rified by recrystallization from water by reference is given in paragraph or aqueous ethanol. The melting range (b)(1) of this section. of the amide is 219° to 220 °C. The substance should have infrared ab- (2) The adipic acid is converted to its sorption bands at 3030, 2630, 1720, 1430, corresponding bis-p-p-bromophenacyl 1300, 1240, 910, 860, 780, and 750 cm¥1. ester. The ester is purified by recrys- Also, an aqueous solution of the sub- tallization from ethanol. The melting stance should have major absorption range of the ester is 153° to 154 °C. peaks at 411 and 432 nanometers with (c) The ingredient is used as a fla- little or no absorption at 389 voring agent as defined in § 170.3(o)(12) nanometers. 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 ter, 0.002 percent for alcoholic bev- this chapter; 0.005 percent for non- erages as defined in § 170.3(n)(2) of this alcoholic beverages as defined in chapter, 0.0015 percent for frozen dairy § 170.3(n)(3) of this chapter; 5.0 percent products as defined in § 170.3(n)(20) of for condiments and relishes as defined this chapter, 0.0035 percent for soft in § 170.3(n)(8) of this chapter; 0.45 per- candy as defined in § 170.3(n)(38) of this cent for dairy product analogs as de- chapter, and 0.0005 percent or less for fined in § 170.3(n)(10) of this chapter; 0.3 all other food categories. percent for fats and oil as defined in (e) Prior sanctions for this ingredient § 170.3(n)(12) of this chapter; 0.0004 per- different from the uses established in cent for frozen dairy desserts as defined this section do not exist or have been in § 170.3(n)(20) of this chapter; 0.55 per- waived. cent for gelatin and puddings as de- [43 FR 47724, Oct. 17, 1978, as amended at 49 fined in § 170.3(n)(22) of this chapter; 0.1 FR 5610, Feb. 14, 1984; 64 FR 1759, Jan. 12, percent for gravies as defined in 1999] § 170.3(n)(24) of this chapter; 0.3 percent for meat products as defined in § 184.1009 Adipic acid. § 170.3(n)(29) of this chapter; 1.3 percent (a) Adipic acid (C6H10O4, CAS Reg. No. for snack foods as defined in 00124–04–9) is also known as 1,4- § 170.3(n)(37) of this chapter; and 0.02 butanedicarboxylic acid or hexane- percent or less for all other food cat- dioic acid. It is prepared by nitric acid egories.
451
VerDate 06
(e) Prior sanctions for adipic acid dif- which is incorporated by reference in ferent from the uses established in this accordance with 5 U.S.C. 552(a) and 1 section do not exist or have been CFR part 51. Copies are available from waived. the National Academy Press, 2101 Con- stitution Ave. NW., Washington, DC [47 FR 27810, June 25, 1982] 20418, or may be examined at the Office § 184.1011 Alginic acid. of Premarket Approval (HFS–200), Cen- ter for Food Safety and Applied Nutri- (a) Alginic acid is a colloidal, hydro- tion, Food and Drug Administration, philic polysaccharide obtained from 1110 Vermont Ave. NW., suite 1200, certain brown algae by alkaline extrac- Washington, DC, or the Office of the tion. Federal Register, 800 North Capitol St. (b) The ingredient meets the speci- NW., suite 700, Washington, DC. fications of the Food Chemicals Codex, (c) In accordance with § 184.1(b)(1), 3d Ed. (1981), p. 13, 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 practices. The affirma- 2101 Constitution Ave. NW., Wash- tion of this ingredient as GRAS as a di- ington, DC 20418, or available for in- rect human food ingredient is based spection at the Office of the Federal upon the following current good manu- Register, 800 North Capitol Street, facturing practice conditions of use: NW., suite 700, Washington, DC 20408. (1) The ingredient is used as an en- (c) In accordance with § 184.1(b)(2), zyme, as defined in § 170.3(o)(9) of this the ingredient is used in food only chapter, in the hydrolysis of edible within the following specific limita- starch to produce maltodextrins and tions: nutritive carbohydrate sweeteners. Maximum level of (2) The ingredient is used at levels Category of food use in food (as Functional use not to exceed current good manufac- served) turing practices. Soup and soup Not to exceed cur- Emulsifier, emulsi- [60 FR 55789, Nov. 3, 1995] mixes, rent good manu- fier salt, § 170.3(n) (40) facturing prac- § 170.3(o)(8) of of this chapter. tice. this chapter; for- § 184.1021 Benzoic acid. mulation aid, (a) Benzoic acid is the chemical § 170.3(o)(14) of this chapter; sta- benzenecarboxylic acid (C7H6O2), occur- bilizer, thickener, ring in nature in free and combined § 170.3(o)(28) of forms. Among the foods in which ben- this chapter. zoic acid occurs naturally are cran- berries, prunes, plums, cinnamon, ripe (d) Prior sanctions for this ingredient cloves, and most berries. Benzoic acid different from the use established in is manufactured by treating molten this section do not exist or have been phthalic anhydride with steam in the waived. presence of a zinc oxide catalyst, by [47 FR 47375, Oct. 26, 1982] the hydrolysis of benzotrichloride, or by the oxidation of toluene with nitric § 184.1012 α-Amylase enzyme prepara- acid or sodium bichromate or with air tion from Bacillus in the presence of a transition metal stearothermophilus. salt catalyst. (a) α-Amylase enzyme preparation is (b) The ingredient meets the speci- obtained from the culture filtrate that fications of the ‘‘Food Chemicals results from a pure culture fermenta- Codex,’’ 3d Ed. (1981), p. 35, which is in- tion of a nonpathogenic and corporated by reference. Copies may be nontoxicogenic strain of Bacillus obtained from the National Academy stearothermophilus. Its characterizing Press, 2101 Constitution Ave. NW., enzyme activity is α-amylase (1,4 α-D Washington, DC 20418, or may be exam- glucan glucanohydrolase (E.C. 3.2.1.1)). ined at the Office of the Federal Reg- (b) The ingredient meets the general ister, 800 North Capitol Street, NW., and additional requirements for en- suite 700, Washington, DC 20408. zyme preparations in the ‘‘Food Chemi- (c) The ingredient is used as an anti- cals Codex,’’ 3d ed. (1981), pp. 107–110, microbial agent as defined in
452
VerDate 06
§ 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 stitution Ave. NW., Washington, DC, or dairy desserts as defined in § 170.3(n)(20) may be examined at the Office of Pre- of this chapter, for gelatins and pud- market Approval (HFS–200), Food and dings as defined in § 170.3(n)(22) of this Drug Administration, 200 C St. SW., chapter, for meat products as defined Washington, DC, and the Office of the in § 170.3(n)(29) of this chapter, and for Federal Register, 800 North Capitol St. soft candy as defined in § 170.3(n)(38) of NW., suite 700, Washington, DC. this chapter; 0.016 percent for snack (c) In accordance with § 184.1(b)(1), foods as defined in § 170.3(n)(37) of this the ingredient is used in food with no chapter; and 0.001 percent or less for all limitation other than current good other food categories. manufacturing practice. The affirma- (e) Prior sanctions for this ingredient tion of this ingredient as GRAS as a di- different from the uses established in rect food ingredient is based upon the this section do not exist or have been following current good manufacturing waived. practice conditions of use: (1) The ingredient is used as an en- [43 FR 19843, May 9, 1978, as amended at 49 FR 5611, Feb. 14, 1984] zyme as defined in § 170.3(o)(9) of this chapter to hydrolyze proteins or § 184.1027 Mixed carbohydrase and polypeptides. protease enzyme product. (2) The ingredient is used in food at (a) Mixed carbohydrase and protease levels not to exceed current good man- enzyme product is an enzyme prepara- ufacturing practice. tion that includes carbohydrase and [60 FR 32910, June 26, 1995] protease activity. It is obtained from
453
VerDate 06
the culture filtrate resulting from a part 51. Copies are available from the pure culture fermentation of a non- National Academy Press, 2101 Constitu- pathogenic strain of B. licheniformis. tion Ave. NW., Washington, DC 20418, (b) The ingredient meets the speci- and the Center for Food Safety and Ap- fications of the Food Chemicals Codex, plied Nutrition (HFS–200), 200 C St. 3d Ed. (1981), p. 107, which is incor- SW., Washington, DC 20204, or may be porated by reference. Copies are avail- examined at the Office of the Federal able from the National Academy Press, Register, 800 North Capitol St. NW., 2101 Constitution Ave. NW., Wash- suite 700, 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, limitations other than current good NW., suite 700, Washington, DC 20408. 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. The affirma- waived. tion of this ingredient as generally rec- 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 current good manufacturing practice: (b) The ingredient meets the general alcoholic beverages, as defined in requirements and additional require- § 170.3(n)(2) of this chapter, candy, nu- ments for enzyme preparations in the tritive sweeteners, and protein Food Chemicals Codex, 3d ed. (1981), p. hydrolyzates. 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 [48 FR 240, Jan. 4, 1983] CFR part 51. Copies are available from the National Academy Press, 2101 Con- § 184.1033 Citric acid. stitution Ave., NW., Washington, DC (a) Citric acid (C6H8O7, CAS Reg. No. 20418, or may be examined at the Office 77–92–9) is the compound 2-hydroxy- of Premarket Approval (HFS–200), Food 1,2,3-propanetricarboxylic acid. It is a and Drug Administration, 200 C St., naturally occurring constituent of SW., Washington, DC, and the Office of plant and animal tissues. It occurs as the Federal Register, 800 North Capitol colorless crystals or a white powder St. NW., suite 700, Washington, DC. and may be anhydrous or contain one (c) In accordance with § 184.1(b)(1), mole of water per mole of citric acid. the ingredient is used in food with no Citric acid may be produced by recov- limitation other than current good ery from sources such as lemon or pine- manufacturing practice. The affirma- apple juice; by mycological fermenta- tion of this ingredient as GRAS as a di- tion using Candida spp., described in rect food ingredient is based upon the §§ 173.160 and 173.165 of this chapter; and following current good manufacturing by the solvent extraction process de- practice conditions of use: scribed in § 173.280 of this chapter for (1) The ingredient is used as an en- the recovery of citric acid from Asper- zyme as defined in § 170.3(o)(9) of this gillus niger fermentation liquor. chapter to decompose hydrogen per- (b) The ingredient meets the speci- oxide. fications of the Food Chemicals Codex, (2) The ingredient is used in food at 3d ed. (1981), pp. 86–87, and its third sup- levels not to exceed current good man- plement (March 1992), pp. 107–108, which ufacturing practice. are incorporated by reference in ac- cordance with 5 U.S.C. 552(a) and 1 CFR [60 FR 32910, June 26, 1995]
454
VerDate 06
§ 184.1061 Lactic acid. phospholipase A2 (EC 3.1.1.4) or pan- creatin. (a) Lactic acid (C H O CAS Reg. 3 6 3, (b) The ingredient meets the speci- Nos.: mixture, 598–82–3; -isomer, 79– DL L fications in paragraphs (b)(1) through 33–4; D-isomer, 10326–41–7), the chemical (b)(8) of this section. Unless otherwise 2-hydroxypropanoic acid, occurs natu- noted, compliance with the specifica- rally in several foods. It is produced tions listed below is determined ac- commercially either by fermentation cording to the methods set forth for of carbohydrates such as glucose, su- lecithin in the Food Chemicals Codex, crose, or lactose, or by a procedure in- 4th ed. (1996), pp. 220–221, which are in- volving formation of lactonitrile from corporated by reference in accordance acetaldehyde and hydrogen cyanide with 5 U.S.C. 552(a) and 1 CFR part 51. and subsequent hydrolysis to lactic Copies are available from the National acid. Academy Press, 2101 Constitution Ave. (b) The ingredient meets the speci- NW., Washington DC 20418, or may be fications of the Food Chemicals Codex, examined at the Center for Food Safety 3d Ed. (1981), p. 159, which is incor- and Applied Nutrition’s Library, 200 C porated by reference. Copies are avail- St. SW., rm. 3321, Washington, DC, or able from the National Academy Press, at the Office of the Federal Register, 2101 Constitution Avenue, NW., Wash- 800 North Capitol St. NW., suite 700, ington, DC 20418, or available for in- Washington, DC. spection at the Office of the Federal (1) Acetone-insoluble matter Register, 800 North Capitol Street, (phosphatides), not less than 50.0 per- NW., suite 700, Washington, DC 20408. cent. (c) In accordance with § 184.1(b)(1), (2) Acid value, not more than 40. the ingredient is used in food with no (3) Lead, not more than 1.0 part per limitation other than current good million, as determined by atomic ab- manufacturing practice. The affirma- sorption spectroscopy. tion of this ingredient as generally rec- (4) Heavy metals (as Pb), not more ognized as safe (GRAS) as a direct than 20 parts per million. human food ingredient is based upon (5) Hexane-insoluble matter, not the following current good manufac- more than 0.3 percent. turing practice conditions of use: (6) Peroxide value, not more than 20. (1) The ingredient is used as an anti- (7) Water, not more than 4.0 percent. microbial agent as defined in (8) Lysolecithin, 50 to 80 mole percent § 170.3(o)(2) of this chapter; a curing and of total phosphatides as determined by pickling agent as defined in § 170.3(o)(5) ‘‘Determination of Lysolecithin Con- of this chapter; a flavor enhancer as de- tent of Enzyme-Modified Lecithin: fined in § 170.3(o)(11) of this chapter; a Method I,’’ dated 1985, which is incor- flavoring agent and adjuvant as defined porated by reference in accordance in § 170.3(o)(12) of this chapter; a pH with 5 U.S.C. 552(a) and 1 CFR part 51. control agent as defined in § 170.3(o)(23) Copies are available from the Division of this chapter; and a solvent and vehi- of Petition Control, Center for Food cle as defined in § 170.3(o)(27) of this Safety and Applied Nutrition (HFS– chapter. 215), Food and Drug Administration, (2) The ingredient is used in food, ex- 200 C St. SW., Washington, DC 20204, or cept in infant foods and infant for- may be examined at the Center for mulas, at levels not to exceed current Food Safety and Applied Nutrition’s good manufacturing practice. Library, 200 C St. SW., rm. 3321, Wash- (d) Prior sanctions for this ingredient ington, DC, or at the Office of the Fed- different from the uses established in eral Register, 800 North Capitol St. this section do not exist or have been NW., suite 700, Washington, DC. waived. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no [49 FR 35367, Sept. 7, 1984] limitation other than current good manufacturing practice. The affirma- § 184.1063 Enzyme-modified lecithin. tion of this ingredient as generally rec- (a) Enzyme-modified lecithin is pre- ognized as safe as a direct human food pared by treating lecithin with either ingredient is based upon the following
455
VerDate 06
current good manufacturing practice this section do not exist or have been conditions of use: waived. (1) The ingredient is used as an emul- [49 FR 48534, Dec. 13, 1984] sifier as defined in § 170.3(o)(8) of this chapter. § 184.1069 Malic acid. (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 [61 FR 45889, Aug. 30, 1996] 1-hydroxy-1, 2-ethanedicarboxylic acid. 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 (C H COOH) (CAS Reg. 17 31 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 fications of the ‘‘Food Chemicals room temperature. Linoleic acid may Codex,’’ 3d Ed. (1981), pp. 183–184, which be prepared from edible fats and oils by is incorporated by reference. Copies various methods including hydrolysis may be obtained from the National and saponification, the Twitchell Academy Press, 2101 Constitution Ave. method, low pressure splitting with NW., Washington, DC 20418, or may be catalyst, continuous high pressure examined at the Office of the Federal counter current splitting, and medium Register, 800 North Capitol Street, pressure autoclave splitting with cata- NW., suite 700, Washington, DC 20408. lyst. (c) The ingredients are used as a fla- (b) FDA is developing food-grade vor enhancer as defined in § 170.3(o)(11) specifications for linoleic acid in co- of this chapter, flavoring agent and ad- operation with the National Academy juvant as defined in § 170.3(o)(12) of this of Sciences. In the interim, this ingre- chapter, and pH control agent as de- dient must be of a purity suitable for fined in § 170.3(o)(23) of this chapter. its intended use. The ingredient must (d) The ingredients are used in food, also meet the specifications in except baby food, at levels not to ex- § 172.860(b) of this chapter. ceed good manufacturing practice in (c) In accordance with § 184.1(b)(1), accordance with § 184.1(b)(1). Current the ingredient is used in food with no good manufacturing practice results in limitation other than current good a maximum level, as served, of 3.4 per- manufacturing practice. The affirma- cent for nonalcoholic beverages as de- tion of this ingredient as generally rec- fined in § 170.3(n)(3) of this chapter; 3.0 ognized as safe (GRAS) as a direct percent for chewing gum as defined in human food ingredient is based upon § 170.3(n)(6) of this chapter; 0.8 percent the following current good manufac- for gelatins, puddings, and fillings as turing practice conditions of use: defined in § 170.3(n)(22) of this chapter; (1) The ingredient is used as a fla- 6.9 percent for hard candy as defined in voring agent and adjuvant as defined in § 170.3(n)(25) of this chapter; 2.6 percent § 170.3(o)(12) of this chapter and as a nu- for jams and jellies as defined in trient supplement as defined in § 170.3(n)(28) of this chapter; 3.5 percent § 170.3(o)(20) of this chapter. for processed fruits and fruit juices as (2) The ingredient is used in foods at defined in § 170.3(n)(35) of this chapter; levels not to exceed current good man- 3.0 percent for soft candy as defined in ufacturing practice. The ingredient § 170.3(n)(38) of this chapter; and 0.7 per- may be used in infant formula in ac- cent for all other food categories. cordance with section 412(g) of the Fed- (e) Prior sanctions for malic acid dif- eral Food, Drug, and Cosmetic Act (the ferent from the uses established in this act) or with regulations promulgated section do not exist or have been under section 412(a)(2) of the act. waived. (d) Prior sanctions for this ingredient [44 FR 20656, Apr. 6, 1979, as amended at 49 different from the uses established in FR 5611, Feb. 14, 1984]
456
VerDate 06
§ 184.1077 Potassium acid tartrate. (d) Prior sanctions for this ingredient different from the uses established in (a) Potassium acid tartrate (C H KO 4 5 6, 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 also called potassium bitartrate or [48 FR 52446, Nov. 18, 1983] cream of tartar. It occurs as colorless or slightly opaque crystals or as a § 184.1081 Propionic acid. 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. § 170.3(o)(16) of this chapter; a leavening (2) The ingredient is used in foods at agent as defined in § 170.3(o)(17) of this levels not to exceed current good man- chapter; A pH control agent as defined ufacturing practice. (d) Prior sanctions for this ingredient in § 170.3(o)(23) of this chapter; a proc- different from the uses established in essing aid as defined in § 170.3(o)(24) of this section do not exist or have been this chapter; a stabilizer and thickener waived. as defined in § 170.3(o)(28) of this chap- ter; and a surface-active agent as de- [49 FR 13141, Apr. 3, 1984] fined in § 170.3(o)(29) of this chapter. (2) The ingredient is used in the fol- § 184.1090 Stearic acid. lowing foods at levels not to exceed (a) Stearic acid (C16H36O2, CAS Reg. current good manufacturing practice: No. 57–11–4) is a white to yellowish baked goods as defined in § 170.3(n)(1) of white solid. It occurs naturally as a this chapter; confections and frostings glyceride in tallow and other animal or as defined in § 170.3(n)(9) of this chap- vegetable fats and oils and is a prin- ter; gelatins and puddings as defined in cipal constituent of most commercially § 170.3(n)(22) of this chapter; hard candy hydrogenated fats. It is produced com- as defined in § 170.3(n)(25) of this chap- mercially from hydrolyzed tallow de- ter; jams and jellies as defined in rived from edible sources or from § 170.3(n)(28) of this chapter; and soft hydrolyzed, completely hydrogenated candy as defined in § 170.3(n)(38) of this vegetable oil derived from edible chapter. sources.
457
VerDate 06
(b) The ingredient meets the speci- turing practice in accordance with fications of the Food Chemicals Codex, § 184.1(b)(1). Current good manufac- 3d Ed. (1981), p. 313, which is incor- turing practice results in a maximum porated by reference, and the require- level, as served, of 0.084 percent in con- ments of § 172.860(b)(2) of this chapter. diments and relishes as defined in Copies of the Food Chemicals Codex § 170.3(n)(8) of this chapter and 0.0061 are available from the National Acad- percent in meat products as defined in emy Press, 2101 Constitution Ave. NW., § 170.3(n)(29) of this chapter. Washington, DC 20418, or available for (e) Prior sanctions for this ingredient inspection at the Office of the Federal different from the uses established in Register, 800 North Capitol Street, this section do not exist or have been NW., suite 700, Washington, DC 20408. waived. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no [44 FR 20657, Apr. 6, 1979, as amended at 49 limitation other than current good FR 5611, Feb. 14, 1984] manufacturing practice. The affirma- § 184.1095 Sulfuric acid. tion of this ingredient as generally rec- ognized as safe (GRAS) as a direct (a) Sulfuric acid (H2SO4, CAS Reg. human food ingredient is based upon No. 7664–93–9), also known as oil of vit- the following current good manufac- riol, is a clear, colorless, oily liquid. It turing practice conditions of use: is prepared by reacting sulfur dioxide (1) The ingredient is used as a fla- (SO2) with oxygen and mixing the re- voring agent and adjuvant as defined in sultant sulfur trioxide (SO3) with § 170.3(o)(12) of this chapter. water, or by reacting nitric oxide (NO) (2) The ingredient is used in foods at with sulfur dioxide and water. levels not to exceed current good man- (b) The ingredient meets the speci- ufacturing practice. fications of the ‘‘Food Chemicals (d) Prior sanctions for this ingredient Codex,’’ 3d Ed. (1981), pp. 317–318, which different from the uses established in is incorporated by reference. Copies this section do not exist or have been may be obtained from the National waived. Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be [48 FR 52445, Nov. 18, 1983, as amended at 50 examined at the Office of the Federal FR 49536, Dec. 3, 1985] Register, 800 North Capitol Street, § 184.1091 Succinic acid. NW., suite 700, Washington, DC 20408. (c) The ingredient is used as a pH (a) Succinic acid (C H O CAS Reg. 4 6 4, control agent as defined in § 170.3(o)(23) No. 110–15–6), also referred to as amber of this chapter and processing aid as acid and ethylenesuccinic acid, is the defined in § 170.3(o)(24) of this chapter. chemical 1,4-butanedioic acid. It is (d) The ingredient is used in food at commercially prepared by hydro- levels not to exceed good manufac- genation of maleic or fumaric acid. It turing practice in accordance with can also be produced by aqueous alkali § 184.1(b)(1). Current good manufac- or acid hydrolysis of succinonitrile. turing practice results in a maximum (b) The ingredient meets the speci- level, as served, of 0.014 percent for al- fications of the ‘‘Food Chemicals coholic beverages as defined in Codex,’’ 3d Ed. (1981), pp. 314–315, which § 170.3(n)(2) of this chapter and 0.0003 is incorporated by reference. Copies percent for cheeses as defined in may be obtained from the National § 170.3(n)(5) of this chapter. Academy Press, 2101 Constitution Ave. (e) Prior sanctions for this ingredient NW., Washington, DC 20418, or may be different from the uses established in examined 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. (c) The ingredient is used as a flavor [45 FR 6085, Jan. 25, 1980, as amended at 49 enhancer as defined in § 170.3(o)(11) of FR 5611, Feb. 14, 1984] this chapter and pH control agent as defined in § 170.3(o)(23) of this chapter. § 184.1097 Tannic acid. (d) The ingredient is used in food at (a) Tannic acid (CAS Reg. No. 1401– levels not to exceed good manufac- 55–4), or hydrolyzable gallotannin, is a
458
VerDate 06
complex polyphenolic organic struc- cluding Rhus semialata, R. coriaria, R. ture that yields gallic acid and either galabra, and R. typhia. glucose or quinic acid as hydrolysis (b) The ingredient meets the speci- products. It is a yellowish-white to fications of the Food Chemicals Codex, light brown substance in the form of an 3d Ed. (1981), p. 319, which is incor- amorphous, bulky powder, glistening porated by reference. Copies are avail- scales, or spongy masses. It is also able from the National Academy Press, ordorless, or has a faint characteristic 2101 Constitution Ave. NW., Wash- odor, and has an astringent taste. Tan- ington, DC 20418, or available for in- nic acid is obtained by solvent extrac- spection at the Office of the Federal tion of nutgalls or excrescences that form on the young twigs of Quercus Register, 800 North Capitol Street, infectoria Oliver and related species of NW., suite 700, Washington, DC 20408. Quercus. Tannic acid is also obtained (c)(1) In accordance with § 184.1(b)(2), by solvent extraction of the seed pods the ingredient is used in food only of Tara (Caesalpinia spinosa) or the within the following specific limita- nutgalls of various sumac species, in- 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- 3d Ed. (1981), P. 320, which is incor- dered animal fat in accordance with 9 porated by reference. Copies are avail- CFR 318.7. 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, [50 FR 21043, May 22, 1985] NW., suite 700, Washington, DC 20408. (c) In accordance with § 184.1(b)(1), § 184.1099 Tartaric acid. the ingredient is used in food with no limitation other than current good (a) Food grade tartaric acid (C H O 4 6 6, manufacturing practice. The affirma- CAS Reg. No. 87–69–4) has the L con- tion of this ingredient as generally rec- figuration. The L form of tartaric acid is dextrorotatory in solution and is ognized as safe (GRAS) as a direct human food ingredient is based upon also known as L¥(+)¥tartaric acid. Tartaric acid occurs as colorless or the following current good manufac- translucent crystals or as a white, turing practice conditions of use: crystalline powder. It is odorless and (1) The ingredient is used as a firm- has an acid taste. It is obtained as a ing agent as defined in § 170.3(o)(10) of byproduct of wine manufacture. this chapter; a flavor enhancer as de- (b) The ingredient meets the speci- fined in § 170.3(o)(11) of this chapter; a fications of the Food Chemicals Codex, flavoring agent as defined in
459
VerDate 06
§ 170.3(o)(12) of this chapter; a humec- fined in § 170.3(o)(8) of this chapter and tant as defined in § 170.3(o)(16) of this a flavoring agent and adjuvant as de- chapter; and a pH control agent as de- fined in § 170.3(o)(12) of this chapter. fined in § 170.3(o)(23) of this chapter. (2) The ingredient is used in the fol- (2) The ingredient is used in foods at lowing foods at levels not to exceed levels not to exceed current good man- current good manufacturing practice: ufacturing practice. baked goods and baking mixes as de- (d) Prior sanctions for this ingredient fined in § 170.3(n)(l) of this chapter; different from the uses established in nonalcoholic beverages as defined in this section do not exist or have been § 170.3(n)(3) of this chapter; confections waived. and frostings as defined in § 170.3(n)(9) [48 FR 52447, Nov. 18, 1983, as amended at 50 of this chapter; dairy product analogs FR 49536, Dec. 3, 1985] as defined in § 170.3(n)(10) of this chap- ter; and fats and oils as defined in § 184.1101 Diacetyl tartaric acid esters § 170.3(n)(12) of this chapter. of mono- and diglycerides. (d) Prior sanctions for this ingredient (a) Diacetyl tartaric acid esters of different from the uses established in mono- and diglycerides, also know as this section do not exist or have been DATEM, are composed of mixed esters waived. of glycerin in which one or more of the hydroxyl groups of glycerin has been (e) Labeling: The acronym ‘‘DATEM’’ esterified by diacetyl tartaric acid and may be used on food labeling as the al- by fatty acids. The ingredient is pre- ternate common or usual name for the pared by the reaction of diacetyl tar- ingredient diacetyl tartaric acid esters taric anhydride with mono- and of mono- and diglycerides. diglycerides that are derived from edi- [54 FR 7403, Feb. 21, 1989, as amended at 54 ble sources. FR 13168, Mar. 31, 1989; 54 FR 18382, Apr. 28, (b) The ingredient meets the speci- 1989; 60 FR 15872, Mar. 28, 1995] fications of the Food Chemicals Codex, 3d. Ed. (1981), pp. 98–99, which is incor- § 184.1115 Agar-agar. porated by reference in accordance (a) Agar-agar (CAS Reg. No. PM 9002– with 5 U.S.C. 552(a). Copies are avail- 18–0) is a dried, hydrophyllic, colloidal able from the National Academy Press, polysaccharide extracted from one of a 2101 Constitution Avenue NW., Wash- number of related species of red algae ington, DC 20418, or available for in- (class ). spection at the Office of the Federal Rhodophyceae Register, 800 North Capitol Street, (b) The ingredient meets the speci- NW., suite 700, Washington, DC 20005. fications of the ‘‘Food Chemicals (c) In accordance with § 184.1(b)(1), Codex,’’ 3d Ed. (1981), p. 11, which is in- the ingredient is used in food with no corporated by reference. Copies may be limitation other than current good obtained from the National Academy manufacturing practice. The affirma- Press, 2101 Constitution Ave. NW., tion of this ingredient as generally rec- Washington, DC 20418, or may be exam- ognized as safe (GRAS) as a direct ined at the Office of the Federal Reg- human food ingredient is based upon ister, 800 North Capitol Street, NW., the following current good manufac- suite 700, Washington, DC 20408. turing practice conditions of use: (c) The ingredient is used in food in (1) The ingredient is used in food as accordance with § 184.1(b)(2) under the an emulsifier and emulsifier salt as de- following conditions:
MAXIMUM USAGE LEVELS PERMITTED
Foods (as served) Percent Functions
Baked goods and baking mixes, § 170.3(n)(1) of this 0.8 Drying agent, § 170.3(o)(7) of this chapter; flavoring agent, chapter. § 170.3(o)(12) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter. Confections and frostings, § 170.3(n)(9) of this chap- 2.0 Flavoring agent, § 170.3(o)(12) of this chapter; stabilizer, ter. thickener, § 170.3(o)(28) of this chapter; surface finisher, § 170.3(o)(30) of this chapter. Soft candy, § 170.3(n)(38) of this chapter ...... 1.2 Stabilizer and thickener, § 170.3(o)(28) of this chapter.
460
VerDate 06
MAXIMUM USAGE LEVELS PERMITTEDÐContinued
Foods (as served) Percent Functions
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 this section do not exist or have been different from the uses established in waived. this section do not exist or have been [47 FR 47376, Oct. 26, 1982] waived. [44 FR 19391, Apr. 3, 1979, as amended at 49 § 184.1121 Red algae. FR 5611, Feb. 14, 1984] (a) Red algae are seaweeds of the spe- cies Gloiopeltis furcata, Porphyra § 184.1120 Brown algae. crispata, Porphyra deutata, Porphyra (a) Brown algae are seaweeds of the perforata, Porphyra suborbiculata, species Analipus japonicus, Eisenia Porphyra tenera and Rhodymenia bicyclis, Hizikia fusiforme, Kjellmaniella palmata. Porphyra and Rhodymenia are gyrata, Laminaria angustata, Laminaria harvested principally along the coasts claustonia, Laminaria digitata, Lam- of Japan, Korea, China, Taiwan, and the East and West coasts of the United inaria japonica, Laminaria longicruris, States. Gloiopeltis is harvested prin- Laminaria longissima, Laminaria cipally in southern Pacific coastal wa- ochotensis, Laminaria saccharina, ters. The material is dried and ground Macrocystis pyrifera, Petalonia fascia, or chopped for use in food. Scytosiphon lomentaria and Undaria (b) The ingredient meets the speci- pinnatifida. They are harvested prin- fications for kelp in the Food Chemi- cipally in coastal waters of the north- cals Codex, 3d Ed. (1981), p. 157, which is ern Atlantic and Pacific oceans. The incorporated by reference, except that material is dried and ground or the loss on drying is not more than 20 chopped for use in food. percent and the maximum allowable (b) The ingredient meets the speci- level for iodine is 0.05 percent. Copies fications for kelp in the Food Chemi- are available from the National Acad- cals Codex, 3d Ed. (1981), p. 157, which is emy Press, 2101 Constitution Ave. NW., incorporated by reference. Copies are Washington, DC 20418, or available for available from the National Academy inspection at the Office of the Federal Press, 2101 Constitution Ave. NW., Register, 800 North Capitol Street, Washington, DC 20418, or available for NW., suite 700, Washington, DC 20408. inspection at the Office of the Federal (c) In accordance with § 184.1(b)(2), Register, 800 North Capitol Street, the ingredient is used in food only NW., suite 700, Washington, DC 20408. within the following specific limita- (c) In accordance with § 184.1(b)(2), tions: the ingredient is used in food only Maximum level of within the following specific limita- Category of food use in food (as Functional use tions: served) Spices, Not to exceed cur- Flavor enhancer, Maximum level of Category of food use in food (as Functional use seasonings, and rent good manu- § 170.3(o)(11) of served) flavorings, facturing prac- this chapter; fla- § 170.3(n) (26) tice. vor adjuvant, Spices, Not to exceed cur- Flavor enhancer, of this chapter. § 170.3(o)(12) of seasonings, and rent good manu- § 170.3(o)(11) of this chapter. flavorings, facturing prac- this chapter; fla- § 170.3(n) (26) tice. vor adjuvant, (d) Prior sanctions for this ingredient of this chapter. § 170.3(o)(12) of different from the use established in this chapter. this section do not exist or have been (d) Prior sanctions for this ingredient waived. different from the use established in [47 FR 47376, Oct. 26, 1982]
461
VerDate 06
§ 184.1133 Ammonium alginate. of ammonium bicarbonate are precip- (a) Ammonium alginate (CAS Reg. itated from solution and subsequently No. 9005–34–9) is the ammonium salt of washed and dried. (b) The ingredient meets the speci- alginic acid, a natural polyuronide con- fications of the Food Chemicals Codex, stituent of certain brown algae. Ammo- 3d Ed. (1981), p. 19, which is incor- nium alginate is prepared by the neu- porated by reference. Copies are avail- tralization of purified alginic acid with able from the National Academy Press, appropriate pH control agents. 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. 18, 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)(2), human food ingredient is based upon the ingredient is used in food only the following current good manufac- within the following specific limita- turing practice conditions of use: tions: (1) The ingredient is used as a dough Maximum strengthener as defined in § 170.3(o)(6) level of of this chapter; a leavening agent as use in Category of food food (as Functional use defined in § 170.3(o)(17) of this chapter; served) a pH control agent as defined in (percent) § 170.3(o)(23) of this chapter; and a Confections, frostings, 0.4 Stabilizer, thickener, texturizer as defined in § 170.3(o)(32) of § 170.3(n)(9) of this § 170.3(o)(28) of this this chapter. chapter. chapter. (2) The ingredient is used in food at Fats and oils, 0.5 Do. § 170.3(n)(12) of this levels not to exceed current good man- chapter. ufacturing practice. Gelatins, puddings, 0.5 Do. (d) Prior sanctions for this ingredient § 170.3(n)(22) of this different from the uses established in chapter. Gravies and sauces, 0.4 Do. this section do not exist or have been § 170.3(n)(24) of this waived. chapter. Jams and jellies, 0.4 Do. [48 FR 52439, Nov. 18, 1983] § 170.3(n)(28) of this chapter. § 184.1137 Ammonium carbonate. Sweet sauces, 0.5 Do. § 170.3(n)(43) of this (a) Ammonium carbonate ((NH4)2CO3, chapter. CAS Reg. No. 8000–73–5) is a mixture of All other food cat- 0.1 Humectant, ammonium bicarbonate (NH HCO ) and egories. § 170.3(o)(16) of this 4 3 chapter; stabilizer, ammonium carbamate (NH2COONH4). thickener, It is prepared by the sublimation of a § 170.3(o)(28) of this mixture of ammonium sulfate and cal- chapter. cium carbonate and occurs as a white (d) Prior sanctions for ammonium al- powder or a hard, white or translucent ginate different from the uses estab- mass. (b) The ingredient meets the speci- lished in this section do not exist or fications of the Food Chemicals Codex, have been waived. 3d Ed. (1981), p. 19, which is incor- [47 FR 29950, July 9, 1982] porated by reference. Copies are avail- able from the National Academy Press, § 184.1135 Ammonium bicarbonate. 2101 Constitution Ave. NW., Wash- (a) Ammonium bicarbonate ington, DC 20418, or available for in- (NH4HCO3, CAS Reg. No. 1066–33–7) is spection at the Office of the Federal prepared by reacting gaseous carbon di- Register, 800 North Capitol Street, oxide with aqueous ammonia. Crystals NW., suite 700, Washington, DC 20408.
462
VerDate 06
(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 this chapter and a pH control agent as waived. defined in § 170.3(o)(23) of this chapter. [48 FR 52439, Nov. 18, 1983] (2) The ingredient is used in food at levels not to exceed current good man- § 184.1139 Ammonium hydroxide. ufacturing practice. (a) Ammonium hydroxide (NH OH, (d) Prior sanctions for this ingredient 4 CAS Reg. No. 1336–21–6) is produced by different from the uses established in this section do not exist or have been passing ammonia gas into water. waived. (b) The ingredient meets the speci- fications of the Food Chemicals Codex, [48 FR 52439, Nov. 18, 1983] 3d Ed. (1981), p. 20, which is incor- porated by reference. Copies are avail- § 184.1138 Ammonium chloride. able from the National Academy Press, (a) Ammonium chloride (NH4Cl, CAS 2101 Constitution Ave. NW., Wash- Reg. No. 12125–02–9) is produced by the ington, DC 20418, or available for in- reaction of sodium chloride and an am- spection at the Office of the Federal monium salt in solution. The less solu- Register, 800 North Capitol Street, ble sodium salt separates out at ele- NW., suite 700, Washington, DC 20408. vated temperatures, and ammonium chloride is recovered from the filtrate (c) In accordance with § 184.1(b)(1), on cooling. Alternatively, hydrogen the ingredient is used in food with no chloride formed by the burning of hy- limitation other than current good drogen in chlorine is dissolved in water manufacturing practice. The affirma- and then reacted with gaseous ammo- tion of this ingredient as generally rec- nia. Ammonium chloride is crystallized ognized as safe (GRAS) as a direct from the solution. 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. 20, which is incor- (1) The ingredient is used as a leav- porated by reference. Copies are avail- ening agent as defined in § 170.3(o)(17) of able from the National Academy Press, this chapter; a pH control agent as de- 2101 Constitution Ave, NW., Wash- fined in § 170.3(o)(23) of this chapter; a ington, DC 20418, or available for in- surface-finishing agent as defined in spection at the Office of the Federal § 170.3(o)(30) of this chapter; and as a Register, 800 North Capitol Street, boiler water additive complying with NW., suite 700, Washington, DC 20408. § 173.310 of this chapter. (c) In accordance with § 184.1(b)(1), (2) The ingredient is used in food at the ingredient is used in food with no levels not to exceed current good man- limitation other than current good ufacturing practice. The ingredient manufacturing practice. The affirma- may also be used as a boiler water ad- tion of this ingredient as generally rec- ditive at levels not to exceed current ognized as safe (GRAS) as a direct good manufacturing practice. human food ingredient is based upon (d) Prior sanctions for this ingredient the following current good manufac- different from the uses established in turing practice conditions of use: this section do not exist or have been (1) The ingredient is used as a dough strengthener as defined in § 170.3(o)(6) waived. of this chapter; a flavor enhancer as de- [48 FR 52440, Nov. 18, 1983, as amended at 59 fined in § 170.3(o)(11) of this chapter; a FR 14551, Mar. 29, 1994]
463
VerDate 06
§ 184.1140 Ammonium citrate, dibasic. limitation other than current good manufacturing practice. The affirma- (a) Ammonium citrate, dibasic tion of this ingredient as generally rec- ((NH ) HC H O CAS Reg. No. 3012–65–5) 4 2 6 5 7, ognized as safe (GRAS) as a direct is the diammonium salt of citric acid. human food ingredient is based upon It is prepared by partially neutralizing the following current good manufac- citric acid with ammonia. turing practice conditions of use: (b) The Food and Drug Administra- tion, in cooperation with the National (1) The ingredient is used as a dough Academy of Sciences, is developing strengthener as defined in § 170.3(o)(6) food-grade specifications for ammo- of this chapter and a pH control agent nium citrate, dibasic. In the interim, as defined in § 170.3(o)(23) of this chap- this ingredient must be of a purity ter. suitable for its intended use. (2) The ingredient is used in food 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 [48 FR 52440, Nov. 18, 1983] the following current good manufac- turing practice conditions of use: § 184.1141b Ammonium phosphate, di- (1) The ingredient is used as a flavor basic. enhancer as defined in § 170.3(o)(11) of (a) Ammonium phosphate, dibasic this chapter and as a pH control agent ((NH4)2HPO4, CAS Reg. No. 7783–28–0) is as defined in § 170.3(o)(23) of this chap- manufactured by reacting ammonia ter. with phosphoric acid at a pH above 5.8. (2) The ingredient is used in non- (b) The ingredient meets the speci- alcoholic beverages as defined in fications of the Food Chemicals Codex, § 170.3(n)(3) of this chapter and in 3d Ed. (1981), p. 21, which is incor- cheeses as defined in § 170.3(n)(5) of this porated by reference. Copies are avail- chapter at levels not to exceed current able from the National Academy Press, good 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, or different from those set Register, 800 North Capitol Street, forth in part 181 of this chapter, do not NW., suite 700, Washington, DC 20408. exist or have been waived. (c) In accordance with § 184.1(b)(1), [59 FR 63896, Dec. 12, 1994] the ingredient is used in food with no limitation other than current good § 184.1141a Ammonium phosphate, manufacturing practice. The affirma- monobasic. tion of this ingredient as generally rec- (a) Ammonium phosphate, monobasic ognized as safe (GRAS) as a direct (NH4H2PO4, CAS Reg. No. 7722–76–1) is human food ingredient is based upon manufactured by reacting ammonia the following current good manufac- with phosphoric acid at a pH below 5.8. turing practice conditions of use: (b) The ingredient meets the speci- (1) The ingredient is used as a dough fications of the Food Chemicals Codex, strengthener as defined in § 170.3(o)(6) 3d Ed. (1981), p. 21, which is incor- of this chapter; a firming agent as de- porated by reference. Copies are avail- fined in § 170.3(o)(10) of this chapter; a able from the National Academy Press, leavening agent as defined in 2101 Constitution Ave. NW., Wash- § 170.3(o)(17) of this chapter; a pH con- ington, DC 20418, or available for in- trol agent as defined in § 170.3(o)(23) of spection at the Office of the Federal this chapter; and a processing aid as Register, 800 North Capitol Street, defined in § 170.3(o)(24) of this chapter. NW., suite 700, Washington, DC 20408. (2) The ingredient is used in food 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.
464
VerDate 06
(d) Prior sanctions for this ingredient total surface area and, hence, pro- different from the uses established in nounced adsorptive capability. this section do not exist or have been (b) FDA is developing food-grade waived. specifications for bentonite in coopera- tion with the National Academy of [48 FR 52440, Nov. 18, 1983] Sciences. In the interim, the ingredient must be of a suitable purity for its in- § 184.1143 Ammonium sulfate. tended use. (a) Ammonium sulfate ((NH4)2SO4, (c) In accordance with § 184.1(b)(1), CAS Reg. No. 7783–20–2) occurs natu- the ingredient is used in food with no rally and consists of colorless or white, limitation other than current good odorless crystals or granules. It is pre- manufacturing practice. The affirma- pared by the neutralization of sulfuric tion of this ingredient as generally rec- acid with ammonium hydroxide. ognized as safe (GRAS) as a direct (b) The ingredient meets the speci- human food ingredient is based upon fications of the ‘‘Food Chemicals the following current good manufac- Codex,’’ 3d Ed. (1981), pp. 22–23, which is turing practice conditions of use: incorporated by reference. Copies may (1) The ingredient is used as a proc- be obtained from the National Acad- essing aid as defined in § 170.3(o)(24) of emy Press, 2101 Constitution Ave. NW., this chapter. Washington, DC 20418, or may be exam- (2) The ingredient is used in food at ined at the Office of the Federal Reg- levels not to exceed current good man- ister, 800 North Capitol Street, NW., ufacturing practice. Current good man- suite 700, Washington, DC 20408. ufacturing practice results in no sig- (c) The ingredient is used as a dough nificant residue in foods. (d) Prior sanctions for this ingredient strengthener as defined in § 170.3(o)(6) different from the uses established in of this chapter, firming agent as de- this section do not exist or have been fined in § 170.3(o)(10) of this chapter, waived. and processing aid as defined in § 170.3(o)(24) of this chapter. [47 FR 43367, Oct. 1, 1982] (d) The ingredient is used in food at levels not to exceed good manufac- § 184.1157 Benzoyl peroxide. turing practice in accordance with (a) Benzoyl peroxide ((C6H5CO)2O2, § 184.1(b)(1). Current good manufac- CAS Reg. No. 94–36–0) is a colorless, turing practice results in a maximum rhombic crystalline solid. It is pre- level, as served, of 0.15 percent for pared by reaction of benzoyl chloride, baked goods as defined in § 170.3(n)(1) of sodium hydroxide, and hydrogen per- this chapter and 0.1 percent for gela- oxide. tins and puddings as defined in (b) The ingredient meets the speci- § 170.1(n)(22) of this chapter. fications of the Food Chemicals Codex, (e) Prior sanctions for this ingredient 3d Ed. (1981), p. 35, which is incor- different from the uses established in porated by reference. Copies are avail- this section do not exist or have been able from the National Academy Press, waived. 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- [45 FR 6086, Jan. 25, 1980; 45 FR 16469, Mar. 14, spection at the Office of the Federal 1980, as amended at 49 FR 5611, Feb. 14, 1984] Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. § 184.1155 Bentonite. (c) In accordance with § 184.1(b)(1), (a) Bentonite (Al2O34SiO2nH2O, CAS the ingredient is used in food with no Reg. No. 1302–0978–099) is principally a limitation other than current good colloidal hydrated aluminum silicate. manufacturing practice. The affirma- Bentonite contains varying quantities tion of this ingredient as generally rec- of iron, alkalies, and alkaline earths in ognized as safe (GRAS) as a direct the commercial products. Depending on human food ingredient is based upon the cations present, natural deposits of the following current good manufac- bentonite range in color from white to turing practice conditions of use: gray, yellow, green, or blue. (1) The ingredient is used as a bleach- Bentonite’s fine particles provide large ing agent in food.
465
VerDate 06
(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 [48 FR 57270, Dec. 29, 1983] siciliano chesse (§ 133.111), Gorgonzola cheese (§ 133.141), Parmesan and § 184.1185 Calcium acetate. reggiano cheese (§ 133.165), Provolone 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. fications for whey, concentrated whey, (b) The ingredient meets the speci- or dried whey in § 184.1979(a) (1), (2), or fications of the Food Chemicals Codex, (3), respectively. 3d Ed. (1981), p. 44, which is incor- porated by reference. Copies are avail- (d) Prior sanctions for this ingredient 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 [51 FR 27173, July 30, 1986] Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. § 184.1165 n-Butane and iso-butane. (c) The ingredient is used as a firm- (a) n-Butane and iso-butane (empir- ing agent as defined in § 170.3(o)(10) of this chapter; pH control agent as de- ical formula C4H10, CAS Reg. Nos. 106– 97–8 and 75–28–5, respectively) are color- fined in § 170.3(o)(23) of this chapter; less, odorless, flammable gases at nor- processing aid as defined in § 170.3(o)(24) mal temperatures and pressures. They of this chapter; sequestrant as defined are easily liquefied under pressure at in § 170.3(o)(26) of this chapter; sta- room temperature and are stored and bilizer and thickener as defined in shipped in the liquid state. The butanes § 170.3(o)(28) of this chapter; and are obtained from natural gas by frac- texturizer as defined in § 170.3(o)(32) of tionation following absorption in oil, this chapter. adsorption to surface-active agents, or (d) The ingredient is used in food at refrigeration. levels not to exceed current good man- (b) The Food and Drug Administra- ufacturing practices in accordance tion is developing food-grade specifica- with § 184.1(b)(1). Current good manu- tions for n-butane and iso-butane in co- facturing practices result in a max- operation with the National Academy imum level, as served, of 0.2 percent for of Sciences. In the interim, the ingredi- baked goods as defined in § 170.3(n)(1) of ents must be of a purity suitable for this chapter; 0.02 percent for cheese as their intended use. defined in § 170.3(n)(5) of this chapter; (c) In accordance with § 184.1(b)(1), 0.2 percent for gelatins, puddings, and these ingredients are used in food with fillings as defined in § 170.3(n)(22) of no limitations other than current good this chapter; 0.15 percent for sweet manufacturing practice. The affirma- sauces, toppings, and syrups as defined tion of these ingredients as generally in § 170.3(n)(43) of this chapter; and recognized as safe (GRAS) as direct 0.0001 percent for all other food cat- human food ingredients is based upon egories. the following current good manufac- (e) Prior sanctions for this ingredient turing practice conditions of use: different from the uses established in (1) The ingredients are used as pro- this section or in part 181 of this chap- pellants, aerating agents, and gases as ter do not exist or have been waived. defined in § 170.3(o)(25) of this chapter. [47 FR 27807, June 25, 1982]
466
VerDate 06
§ 184.1187 Calcium alginate. in this section do not exist or have been waived. (a) Calcium alginate (CAS Reg. No. 9005–35–0) is the calcium salt of alginic [47 FR 29951, July 9, 1982] acid, a natural polyuronide constituent of certain brown algae. Calcium algi- § 184.1191 Calcium carbonate. nate is prepared by the neutralization (a) Calcium carbonate (CaCO3, CAS of purified alginic acid with appro- Reg. No. 471–34–1) is prepared by three priate pH control agents, or from so- common methods of manufacture: dium alginate by metathesis with ap- (1) As a byproduct in the ‘‘Lime soda propriate calcium salts. process’’; (2) By precipitation of calcium car- (b) The ingredient meets the speci- bonate from calcium hydroxide in the fications of the Food Chemicals Codex, ‘‘Carbonation process’’; or 3d Ed. (1981), p. 45, which is incor- (3) By precipitation of calcium car- porated by reference. Copies are avail- bonate from calcium chloride in the able from the National Academy Press, ‘‘Calcium chloride process’’. 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. 46, 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 (c) In accordance with § 184.1(b)(1), level of use in the ingredient is used in food with no Category of food food (as Functional use limitation other than current good served) (percent) manufacturing practice. (d) Prior sanctions for this ingredient Baked goods, 0.002 Stabilizer, thickener, different from the uses established in § 170.3(n)(1) of this § 170.3(o)(28) of this chapter. chapter. this section, or different from that set Alcoholic beverages, 0.4 Do. forth in part 181 of this chapter, do not § 170.3(n)(2) of this exist or have been waived. chapter. Confections and 0.4 Do. [48 FR 52441, Nov. 18, 1983] frostings, § 170.3(n)(9) of this § 184.1193 Calcium chloride. chapter. Egg products, 0.6 Do. (a) Calcium chloride (CaCl2·2H2O, § 170.3(n)(11) of this CAS Reg. No. 10035–04–8) or anhydrous chapter. calcium chloride (CaCl2, CAS Reg. No. Fats and oils, 0.5 Do. 10043–52–4) may be commercially ob- § 170.3(n)(12) of this chapter. tained as a byproduct in the ammonia- Gelatins, puddings, 0.25 Do. soda (Solvay) process and as a joint § 170.3(n)(22) of this product from natural salt brines, or it chapter. may be prepared by substitution reac- Gravies and sauces, 0.4 Do. § 170.3(n)(24) of this tions with other calcium and chloride chapter. salts. Jams and jellies, 0.5 Do. (b) The ingredient meets the speci- § 170.3(n)(28) of this fications of the Food Chemicals Codex, chapter. Sweet sauces, 0.5 Do. 3d Ed. (1981), p. 47, which is incor- § 170.3(n)(43) of this porated by reference. Copies are avail- chapter. able from the National Academy Press, All other food cat- 0.3 Do. 2101 Constitution Ave. NW., Wash- egories. ington, DC 20418, or available for in- spection at the Office of the Federal (d) Prior sanctions for calcium algi- Register, 800 North Capitol Street, nate different from the uses established NW., suite 700, Washington, DC 20408.
467
VerDate 06
(c) The ingredient is used as an this section do not exist or have been anticaking agent as defined in waived. § 170.3(o)(1) of this chapter; anti- [47 FR 27808, June 25, 1982, as amended at 61 microbial agent as defined in FR 14247, Apr. 1, 1996] § 170.3(o)(2) of this chapter; curing or pickling agent as defined in § 170.3(o)(5) § 184.1195 Calcium citrate. of this chapter; firming agent as de- (a) Calcium citrate fined in § 170.3(o)(10) of this chapter; (Ca (C H O ) ·4H O, CAS Reg. No. 813– flavor enhancer as defined in 3 6 5 7 2 2 0994–095) is the calcium salt of citric § 170.3(o)(11) of this chapter; humectant acid. It is prepared by neutralizing cit- as defined in § 170.3(o)(16) of this chap- ric acid with calcium hydroxide or cal- ter; nutrient supplement as defined in cium carbonate. It occurs as a fine § 170.3(o)(20) of this chapter; pH control white, odorless powder and usually agent as defined in § 170.3(o)(23) of this contains four moles of water per mole chapter; processing aid as defined in of calcium citrate. § 170.3(o)(24) of this chapter; stabilizer (b) The ingredient meets the speci- and thickener as defined in § 170.3(o)(28) fications of the Food Chemicals Codex, of this chapter; surface-active agent as 3d ed. (1981), pp. 49 and 50, which is in- defined in § 170.3(o)(29) of this chapter; corporated by reference in accordance synergist as defined in § 170.3(o)(31) of with 5 U.S.C. 552(a) and 1 CFR part 51. this chapter; and texturizer as defined Copies are available from the National in § 170.3(o)(32) of this chapter. Academy Press, 2101 Constitution Ave. (d) The ingredient is used in foods at NW., Washington, DC 20418, and the levels not to exceed current good man- Center for Food Safety and Applied Nu- ufacturing practices in accordance trition (HFS–200), 200 C St. SW., Wash- with § 184.1(b)(1). Current good manu- ington, DC 20204, or may be examined facturing practices result in a max- at the Office of the Federal Register, imum level, as served, of 0.3 percent for 800 North Capitol St. NW., suite 700, baked goods as defined in § 170.3(n)(1) of Washington, DC. this chapter and for dairy product (c) In accordance with § 184.1(b)(1), analogs as defined in § 170.3(n)(10) of the ingredient is used in food with no this chapter; 0.22 percent for non- limitation other than current good alcoholic beverages and beverage bases manufacturing practice. Calcium cit- as defined in § 170.3(n)(3) of this chap- rate may also be used in infant formula ter; 0.2 percent for cheese as defined in in accordance with section 412(g) of the § 170.3(n)(5) of this chapter and for proc- Federal Food, Drug, and Cosmetic Act essed fruit and fruit juices as defined in (the act) or with regulations promul- § 170.3(n)(35) of this chapter; 0.32 per- gated under section 412(a)(2) of the act. cent for coffee and tea as defined in (d) Prior sanctions for this ingredient § 170.3(n)(7) of this chapter; 0.4 percent different from the uses established in for condiments and relishes as defined this section do not exist or have been in § 170.3(n)(8) of this chapter; 0.2 per- waived. cent for gravies and sauces as defined [59 FR 63896, Dec. 12, 1994] in § 170.3(n)(24) of this chapter; 0.1 per- cent for commercial jams and jellies as § 184.1199 Calcium gluconate. defined in § 170.3(n)(28) of this chapter; 0.25 percent for meat products as de- (a) Calcium gluconate fined in § 170.3(n)(29) of this chapter; 2.0 ([CH2OH(CHOH)4COO]2Ca, CAS Reg. No. percent for plant protein products as 299–28–5) is the calcium salt of gluconic acid which may be produced by neu- defined in § 170.3(n)(33) of this chapter; tralization of gluconic acid with lime 0.4 percent for processed vegetables and or calcium carbonate. vegetable juices as defined in (b) The ingredient meets the speci- § 170.3(n)(36) of this chapter; and 0.05 fications of the Food Chemicals Codex, percent for all other food categories. 3d Ed. (1981), p. 51, which is incor- (e) Prior sanctions for this ingredient porated by reference. Copies are avail- different from the uses established in able from the National Academy Press,
468
VerDate 06
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. § 170.3(n)(22) of this chapter; and 0.01 (b) The ingredient meets the speci- percent for sugar substitutes as defined fications of the Food Chemicals Codex, in § 170.3(n)(42) of this chapter. 3d Ed. (1981), p. 52, which is incor- (e) 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- [47 FR 27808, June 25, 1982] spection at the Office of the Federal Register, 800 North Capitol Street, § 184.1201 Calcium glycerophosphate. NW., suite 700, Washington, DC 20408. (a) Calcium glycerophosphate (c) In accordance with § 184.1(b)(1), (C3H7CaO6P, CAS Reg. No. 27214–00–2) is the ingredient is used in food with no a fine, white, odorless, almost taste- limitation other than current good less, slightly hygroscopic powder. It is manufacturing practice. prepared by neutralizing glycero- (d) Prior sanctions for this ingredient phosphoric acid with calcium hydrox- different from the uses established in ide or calcium carbonate. The commer- this section do not exist or have been cial product is a mixture of calcium β- waived. , and D-, and L-α-glycerophosphate. (b) The ingredient meets the speci- [49 FR 26714, June 29, 1984] fications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), pp. 51–52, which is § 184.1206 Calcium iodate. incorporated by reference in accord- (a) Calcium iodate [Ca(IO3)2·H2O, CAS ance with 5 U.S.C. 552(a) and 1 CFR Reg. No. 7789–80–2], also referred to as part 51. Copies may be obtained from lautarite, does not occur naturally but the National Academy Press, 2101 Con- can be prepared by passing chlorine stitution Ave. NW., Washington, DC into a hot solution of lime (CaCO3) in 20418, or may be examined at the Office which iodine has been dissolved. of the Federal Register, 800 North Cap- (b) The ingredient meets the speci- itol Street, NW., suite 700, Washington, fications of the ‘‘Food Chemicals DC. Codex,’’ 3d Ed. (1981), p. 53, which is in- (c) In accordance with § 184.1(b)(1), corporated by reference. Copies may be the ingredient is used in food with no obtained from the National Academy limitation other than current good Press, 2101 Constitution Ave. NW.,
469
VerDate 06
Washington, DC 20418, or may be exam- mulas, at levels not to exceed current ined at the Office of the Federal Reg- good manufacturing practice. ister, 800 North Capitol Street, NW., (d) Prior sanctions for this ingredient suite 700, Washington, DC 20408. different from the uses established in (c) The ingredient is used as a dough this section do not exist or have been strengthener as defined in § 170.3(o)(6) waived. of this chapter. [49 FR 35367, Sept. 7, 1984] (d) The ingredient is used in the man- ufacture of bread in accordance with § 184.1210 Calcium oxide. § 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- [43 FR 11699, Mar. 21, 1978, as amended at 49 fications of the Food Chemicals Codex, FR 5611, Feb. 14, 1984] 3d Ed. (1981), p. 55, which is incor- porated by reference. Copies are avail- § 184.1207 Calcium lactate. able from the National Academy Press, 2101 Constitution Ave. NW., Wash- (a) Calcium lactate (C6H10CaO6.xH2O, where x is any integer up to 5, CAS ington, DC 20418, or available for in- Reg. No. 814–80–2) is prepared commer- spection at the Office of the Federal cially by the neutralization of lactic Register, 800 North Capitol Street, acid with calcium carbonate or cal- NW., suite 700, Washington, DC 20408. cium hydroxide. (c) In accordance with § 184.1(b)(1), (b) The ingredient meets the speci- the ingredient is used in food with no fications of the Food Chemicals Codex, limitation other than current good 3d Ed. (1981), p. 53, which is incor- manufacturing practice. porated by reference. Copies are avail- (d) Prior sanctions for this ingredient able from the National Academy Press, different from the uses established in 2101 Constitution Avenue 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 [49 FR 26714, June 29, 1984] Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. § 184.1212 Calcium pantothenate. (c) In accordance with § 184.1(b)(1), (a) Calcium pantothenate the ingredient is used in food with no ((C9H16NO5)2Ca, CAS Reg. No. of the D- limitation other than current good isomer, 137–08–6) is a salt of panto- manufacturing practice. The affirma- thenic acid, one of the vitamins of the tion of this ingredient as generally rec- B complex. Only the D-isomer of panto- ognized as safe (GRAS) as a direct thenic acid has vitamin activity, al- human food ingredient is based upon though both the D-isomer and the DL- the following current good manufac- racemic mixture of calcium panto- turing practice conditions of use: thenate are used in food. Commercial (1) The ingredient is used as a firm- calcium pantothenate is prepared syn- ing agent as defined in § 170.3(o)(10) of thetically from isobutyraldehyde and this chapter; a flavor enhancer as de- formaldehyde via 1,1-dimethyl-2-hy- fined in § 170.3(o)(11) of this chapter; a droxy-propionaldehyde and flavoring agent or adjuvant as defined pantolactone. in § 170.3(o)(12) of this chapter; a leav- (b) Calcium pantothenate meets the ening agent as defined in § 170.3(o)(17) of specifications of the Food Chemicals this chapter; a nutrient supplement as Codex, 3d Ed. (1981), p. 56, which is in- defined in § 170.3(o)(20) of this chapter; corporated by reference. Copies are and a stabilizer and thickener as de- available from the National Academy fined in § 170.3(o)(28) of this chapter. Press, 2101 Constitution Ave. NW., (2) The ingredient is used in food, ex- Washington, DC 20418, or available for cept in infant foods and infant for- inspection at the Office of the Federal
470
VerDate 06
Register, 800 North Capitol Street, (2) The ingredient is used in the fol- NW., suite 700, Washington, DC 20408. lowing foods at levels not to exceed (c) In accordance with § 184.1(b)(1), current good manufacturing practice: the ingredient is used in food with no baked goods as defined in § 170.3(n)(1) of limitation other than current good this chapter; cheeses as defined in manufacturing practice. The affirma- § 170.3(n)(5) of this chapter; confections tion of this ingredient as generally rec- and frostings as defined in § 170.3(n)(9) ognized as safe (GRAS) as a direct of this chapter; gelatins, puddings, and human food ingredient is based upon fillings as defined in § 170.3(n)(22) of the following current good manufac- this chapter; and jams and jellies as de- turing practice conditions of use: fined in § 170.3(n)(28) of this chapter. (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. 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 this section do not exist or have been and sodium stearate in aqueous solu- waived. tion. [48 FR 51908, Nov. 15, 1983] (b) The ingredient meets the speci- fications of the Food Chemicals Codex, § 184.1221 Calcium propionate. 3d Ed. (1981), p. 64, which is incor- porated by reference, and the require- (a) Calcium propionate (C6H10CaO4, CAS Reg. No. 4075–81–4) is the calcium ments of § 172.860(b)(2) of this chapter. salt of propionic acid. It occurs as Copies of the Food Chemicals Codex white crystals or a crystalline solid, are available from the National Acad- possessing not more than a faint odor emy Press, 2101 Constitution Ave. NW., of propionic acid. It is prepared by neu- Washington, DC 20418, or available for tralizing propionic acid with calcium inspection at the Office of the Federal hydroxide. 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. 60, 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 fla- the ingredient is used in food with no voring agent and adjuvant as defined in limitation other than current good § 170.3(o)(12) of this chapter; a lubricant manufacturing practice. The affirma- and release agent as defined in tion of this ingredient as generally rec- § 170.3(o)(18) of this chapter; and a sta- ognized as safe (GRAS) as a direct bilizer and thickener as defined in human food ingredient is based upon § 170.3(o)(28) of this chapter. the following current good manufac- (2) The ingredient is used in foods at turing practice conditions of use: levels not to exceed current good man- (1) The ingredient is used as an anti- ufacturing practice. microbial agent as defined in (d) Prior sanctions for this ingredient § 170.3(o)(2) of this chapter. different from the uses established in
471
VerDate 06
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 § 170.3(n)(22) of this chapter, 0.5 percent [48 FR 52445, Nov. 18, 1983] for grain products and pastas as de- § 184.1230 Calcium sulfate. fined in § 170.3(n)(23) of this chapter, 0.35 percent for processed vegetables as (a) Calcium sulfate (CaSO CAS Reg. 4, defined in § 170.3(n)(36) of this chapter, No. 7778–18–9 or CaSO ·2H O, CAS Reg. 4 2 and 0.07 percent or less for all other No. 10101–41–4), also known as plaster of 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 (c) The ingredient is used as an as a byproduct of the manufacture of anticaking agent as defined in lime during the ‘‘burning’’ of lime- § 170.3(o)(1) of this chapter, color and stone, from the combustion of carbo- coloring adjunct as defined in naceous material, from fermentation § 170.3(o)(4) of this chapter, dough processes, and from gases found in cer- strengthener as defined in § 170.3(o)(6) tain natural springs and wells. of this chapter, drying agent as defined in § 170.3(o)(7) of this chapter, firming (b) The Food and Drug Administra- agent as defined in § 170.3(o)(10) of this tion is developing food-grade specifica- chapter, flour treating agent as defined tions for carbon dioxide in cooperation in § 170.3(o)(13) of this chapter, formula- with the National Academy of tion aid as defined in § 170.3(o)(14) of Sciences. In the interim, the ingredient this chapter, leavening agent as de- must be of purity suitable for its in- fined in § 170.3(o)(17) of this chapter, nu- tended use. trient supplement as defined in (c) In accordance with § 184.1(b)(1), § 170.3(o)(20) of this chapter, pH control the ingredient is used in food with no agent as defined in § 170.3(o)(23) of this limitations other than current good chapter, processing aid as defined in manufacturing practice. The affirma- § 170.3(o)(24) of this chapter, stabilizer tion of this ingredient as generally rec- and thickener as defined in § 170.3(o)(28) ognized as safe (GRAS) as a direct of this chapter, synergist as defined in human food ingredient is based upon § 170.3(o)(31) of this chapter, and the following current good manufac- texturizer as defined in § 170.3(o)(32) of turing practice conditions of use: this chapter. (1) The ingredient is used as a leav- (d) The ingredient is used in food at ening agent as defined in § 170.3(o)(17) of levels not to exceed good manufac- this chapter; a processing aid as de- turing practice in accordance with fined in § 170.3(o)(24) of this chapter; § 184.1(b)(1). Current good manufac- and a propellant, aerating agent, and turing practice results in a maximum gas as defined in § 170.3(o)(25) of this level, as served, of 1.3 percent for baked chapter. goods as defined in § 170.3(n)(1) of this (2) The ingredient is used in food at chapter, 3.0 percent for confections and levels not to exceed current good man- frostings as defined in § 170.3(n)(9) of ufacturing practice. this chapter, 0.5 percent for frozen (d) Prior sanctions for this ingredient dairy desserts and mixes as defined in different from the uses established in
472
VerDate 06
this section do not exist or have been § 184.1257 Clove and its derivatives. waived. (a) Cloves are the dried unopened [48 FR 57270, Dec. 29, 1983] flower buds and calyx tubes, harvested before the flowers have opened, of the § 184.1245 Beta-carotene. clove tree Eugenia caryophyllata (a) Beta-carotene (CAS Reg. No. 7235– Thunberg, native to tropical Asia. Their derivatives include essential oils 40–7) has the molecular formula C40H56. It is synthesized by saponification of (cloves, CAS Reg. No. 8000–34–8; buds; vitamin A acetate. The resulting alco- leaves, CAS Reg. No. 8015–97–2; stems, hol is either reacted to form vitamin A CAS Reg. No. 8015–98–3; and eugenol, Wittig reagent or oxidized to vitamin A CAS Reg. No. 97–53–0), oleoresins, and aldehyde. Vitamin A Wittig reagent natural extractives obtained from and vitamin A aldehyde are reacted to- clove buds, leaves, and stems. gether to form beta-carotene. (b) Clove bud oil, clove leaf oil, clove (b) The ingredient meets the speci- stem oil, and eugenol meet the speci- fications of the Food Chemicals Codex, fications of the ‘‘Food Chemicals Codex,’’ 4th ed. (1996), pp. 104–105, which 3d Ed. (1981), p. 73, which is incor- is incorporated by reference in accord- porated by reference. Copies are avail- ance with 5 U.S.C. 552(a) and 1 CFR able from the National Academy Press, part 51. Copies are available from the 2101 Constitution Ave. NW., National Academy Press, Box 285, 2101 Washingtion, DC 20418, or available for Constitution Ave. NW., Washington, inspection at the Office of the Federal DC 20055 (Internet address ‘‘http:// Register, 800 North Capitol Street, www.nap.edu’’), or may be examined at NW., suite 700, Washington, DC 20408. the Center for Food Safety and Applied (c) In accordance with § 184.1(b)(1), Nutrition’s Library, Food and Drug Ad- the ingredient is used in food with no ministration, 200 C St. SW., rm. 3321, limitation other than current good Washington, DC, or at the Office of the manufacturing practice. The affirma- Federal Register, 800 North Capitol St. tion of this ingredient as generally rec- NW., suite 700, Washington, DC. As de- ognized as safe (GRAS) as a direct termined by analytical methods in the human food ingredient is based upon ‘‘Food Chemicals Codex,’’ clove oleo- the following current good manufac- resin or other natural extractives turing practice conditions of use: (other than clove oils) meet the ‘‘Food (1) The ingredient is used as a nutri- Chemicals Codex’’ specifications for ent supplement as defined in clove (clove bud) oil and the following § 170.3(o)(20) of this chapter. modifications: (2) The ingredient is used in the fol- (1) The assay for phenols, as eugenol, lowing foods at levels not to exceed by the ‘‘Food Chemicals Codex’’ test, current good manufacturing practice: 4th ed. (pp. 104–105), or the volatile oils dairy product analogs as defined in content by the ‘‘Food Chemicals § 170.3(n)(10) of this chapter; fats and Codex’’ test, 4th ed. (pp. 104–105) should oils as defined in § 170.3(n)(12) of this conform to the representation of the chapter; and processed fruits and fruit vendor; juices as defined in § 170.3(n)(35) of this (2) Optical rotation of the volatile oil chapter. Beta-carotene may be used in between ¥2° and 0°; infant formula as a source of vitamin A (3) Refractive index of the volatile oil in accordance with section 412(g) of the between 1.527 and 1.538 at 20 °C; Federal Food, Drug, and Cosmetic Act (4) Specific gravity of the volatile oil or with regulations promulgated under between 1.036 and 1.060; and section 412(g) of the act. (5) Residual solvent free, except those (d) Prior sanctions for this ingredient solvents that are GRAS or within tol- different from the uses established in erance levels as specified in part 173, this section do not exist or have been subpart C, of this chapter. waived. (c) Clove and its derivatives are used as flavoring agents and adjuvants as [52 FR 25211, July 6, 1987] defined in § 170.3(0)(12) of this chapter.
473
VerDate 06
(d) The ingredients are used in food (1996), pp. 760–761, which is incorporated at levels not to exceed good manufac- by reference in accordance with 5 turing practice in accordance with U.S.C. 552(a) and 1 CFR part 51. Copies § 184.1(b)(1). are available from the National Acad- (e) Prior sanctions for these ingredi- emy Press, Box 285, 2101 Constitution ents different from the uses established Ave. NW., Washington, DC 20055 (Inter- in this section do not exist or have net address ‘‘http://www.nap.edu’’), or been waived. may be examined at the Center for [44 FR 3964, Jan 19, 1979, as amended at 47 FR Food Safety and Applied Nutrition’s 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, 1984; Library, Food and Drug Administra- 64 FR 1759, Jan. 12, 1999] tion, 200 C St. SW., rm. 3321, Wash- ington, DC, or at the Office of the Fed- § 184.1259 Cocoa butter substitute. eral Register, 800 North Capitol St. (a) The common or usual name for NW., suite 700, Washington, DC. the triglyceride 1-palmitoyl-2-oleoyl-3- (4) Color—clear, bright, and free from stearin is ‘‘cocoa butter substitute pri- suspended matter. marily from palm oil.’’ The common or (5) Odor and taste—free from foreign usual name for the triglyceride 1-3- and rancid odor and taste. distearoyl-2-olein is ‘‘cocoa butter sub- (6) Residual catalyst (‘‘Official Meth- stitute primarily from high-oleic saf- ods of Analysis of the Association of flower or sunflower oil.’’ Official Analytical Chemists,’’ 13th Ed. (1) The ingredient 1-palmitoyl-2-ole- (1980), sections 25.049–25.055, which is oyl-3-stearin is manufactured by: incorporated by reference), residual (i) Directed esterification of fully fluorine; limit of detection 0.2 part per saturated 1,3-diglycerides (derived from million F; multiply fluoride result by palm oil) with the anhydride of food- 2.63 to convert to residual catalyst. grade oleic acid in the presence of the Copies of the material incorporated by catalyst trifluoromethane sulfonic acid reference may be obtained from the As- (§ 173.395 of this chapter), or sociation of Official Analytical Chem- (ii) By interesterification of partially ists, P.O. Box 540, Benjamin Franklin saturated 1,2,3-triglycerides (derived Station, Washington, DC 20044, or may from palm oil) with ethyl stearate in be examined at the Office of the Fed- the presence of a suitable lipase en- eral Register, 800 North Capitol Street, zyme preparation that is either gen- NW., suite 700, Washington, DC 20408. erally recognized as safe (GRAS) or has The ingredient shall be washed three food additive approval for such use. times in batches with 0.5 percent so- (2) The ingredient 1-3-distearoyl-2- dium bicarbonate to remove catalyst olein is manufactured by residuals in accordance with good man- interesterification of partially unsatu- ufacturing practice. rated 1,2,3-triglycerides (derived from (7) Residual methanol—5 parts per high-oleic safflower or sunflower oil) million maximum. with ethyl stearate or stearic acid in (8) Residual fatty acid ethyl esters— the presence of a suitable lipase en- not more than 20 parts per million as zyme preparation that is either GRAS determined by a ‘‘Modification of or has food additive approval for such Japan Institute of Oils and Fats: Anal- use. ysis Method of Residual Ethyl Esters of (b) The ingredient meets the fol- Fatty Acids’’ issued by the Fuji Oil lowing specifications: Co., which is incorporated by reference. (1) Over 90 percent triglycerides, not Copies are available from the Division more than 7 percent diglycerides, not of Food and Color Additives, Center for more than 1 percent monoglycerides, Food Safety and Applied Nutrition and not more than 1 percent free fatty (HFS–200), Food and Drug Administra- acids. tion, 200 C St. SW., Washington, DC (2) Total glycerides—98 percent min- 20204, or available for inspection at the imum. 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
474
VerDate 06
Dupuy et al., ‘‘Rapid Quantitative De- limitation other than current good termination of Residual Hexane in Oils manufacturing practice. The affirma- by Direct Gas Chromatography,’’ pub- tion of this ingredient as generally rec- lished in the ‘‘Journal of the American ognized as safe (GRAS) as a direct Oil Chemists’ Society,’’ Vol. 52, p. 118– human food ingredient is based upon 120, 1975, which is incorporated by ref- the following current good manufac- erence. Copies are available from the turing practice conditions of use: Division of Food and Color Additives, (1) The ingredient is used as a nutri- Center for Food Safety and Applied Nu- ent supplement as defined in trition (HFS–200), Food and Drug Ad- § 170.3(o)(20) of this chapter and as a ministration, 200 C St. SW., Wash- synergist as defined in § 170.3(o)(31) of ington, DC 20204, or available for in- this chapter. spection at the Office of the Federal (2) The ingredient is used in food at Register, 800 North Capitol Street, levels not to exceed current good man- NW., suite 700, Washington, DC 20408. ufacturing practice. Copper gluconate (c) In accordance with § 184.1(b)(1), may be used in infant formula in ac- the ingredient is used in the following cordance with section 412(g) of the Fed- food categories at levels not to exceed eral Food, Drug, and Cosmetic Act (the current good manufacturing practice: Act) or with regulations promulgated Confections and frostings as defined in under section 412(a)(2) of the Act. § 170.3(n)(9) of this chapter; coatings of (d) Prior sanctions for this ingredient soft candy as defined in §170.3(n)(38) of different from the uses established in this chapter; and sweet sauces and top- this section do not exist or have been pings as defined in §170.3(n)(43) of this waived. chapter; except that the ingredient [49 FR 24119, June 12, 1984] may not be used in a standardized food unless permitted by the standard of § 184.1261 Copper sulfate. identity. (a) Copper sulfate (cupric sulfate, (d) The ingredient is used in food in CuSO4·5H2O, CAS Reg. No. 7758–98–7) accordance with § 184.1(b)(1) at levels usually is used in the pentahydrate not to exceed good manufacturing form. This form occurs as large, deep practice. blue or ultramarine, triclinic crystals; [43 FR 54239, Nov. 11, 1978, as amended at 47 as blue granules, or as a light blue pow- FR 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, der. The ingredient is prepared by the 1984; 49 FR 22799, June 1, 1984; 52 FR 47920, reaction of sulfuric acid with cupric Dec. 17, 1987; 52 FR 48905, Dec. 28, 1987; 61 FR oxide or with copper metal. 36290, July 10, 1996; 64 FR 1760, Jan. 12, 1999] (b) FDA is developing food-grade specifications for copper sulfate in co- § 184.1260 Copper gluconate. operation with the National Academy (a) Copper gluconate (cupric gluco- of Sciences. In the interim, this ingre- nate (CH2OH(CHOH)4COO)2Cu, CAS dient must be of a purity suitable for Reg. No. 527–09–3) is a substance that its intended use. occurs as light blue to bluish-green, (c) In accordance with § 184.1(b)(1), odorless crystals, or as a fine, light the ingredient is used in food with no blue powder. It is prepared by the reac- limitation other than current good tion of gluconic acid solutions with cu- manufacturing practice. The affirma- pric oxide or basic cupric carbonate. tion of this ingredient as generally rec- (b) The ingredient meets the speci- ognized as safe (GRAS) as a direct fications of the Food Chemicals Codex, human food ingredient is based upon 3d Ed. (1981), p. 90, which is incor- the following current good manufac- porated by reference. Copies are avail- turing practice conditions of use: able from the National Academy Press, (1) The ingredient is used as a nutri- 2101 Constitution Ave. NW., Wash- ent supplement as defined in ington, DC. 20418, or available for in- § 170.3(o)(20) of this chapter and as a spection at the Office of the Federal processing aid as defined in § 170.3(o)(24) Register, 800 North Capitol Street, of this chapter. NW., suite 700, Washington, DC. 20408. (2) The ingredient is used in food 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. Copper sulfate
475
VerDate 06
may be used in infant formula in ac- white crystalline powder. It is prepared cordance with section 412(g) of the Fed- by the reaction of copper sulfate with eral Food, Drug, and Cosmetic Act (the potassium iodide under slightly acidic Act) or with regulations promulgated conditions. under section 412(a)(2) of the Act. (b) FDA is developing food-grade (d) Prior sanctions for this ingredient specifications for cuprous iodide in co- different from the uses established in operation with the National Academy this section do not exist or have been of Sciences. In the interim, this ingre- waived. dient must be of a purity suitable for [49 FR 24119, June 12, 1984] its intended use. (c) In accordance with § 184.1(b)(2), § 184.1262 Corn silk and corn silk ex- the ingredient is used in food only tract. within the following specific limita- (a) Corn silk is the fresh styles and tions: stigmas of Zea mays L. collected when the corn is in milk. The filaments are Cat- egory Maximum treatment Functional use extracted with dilute ethanol to of food level in food produce corn silk extract. The extract may be concentrated at a temperature Table 0.01 percent ...... Source of dietary iodine. not exceeding 60 °C. salt. (b) The Food and Drug Administra- tion, in cooperation with the National (d) Prior sanctions for this ingredient Academy of Sciences, is developing different from the uses established in food-grade specifications for corn silk this section do not exist or have been and corn silk extract. In the interim, waived. this ingredient must be of a suitable [49 FR 24119, June 12, 1984] purity for its intended use. (c) In accordance with § 184.1(b)(2), § 184.1271 L-Cysteine. the ingredients are used in food only within the following specific limita- (a) L-Cysteine is the chemical L-2- tions: amino-3-mercaptopropanoic acid (C3H7O2NS). Maximum (b) The ingredient meets the appro- level of Category of food use in Functional use priate part of the specification set food (as served)1 forth in the ‘‘Food Chemicals Codex,’’ 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 § 170.3(n)(1) of this chapter. obtained from the National Academy chapter. Press, 2101 Constitution Ave. NW., Nonalcoholic bev- 20 Do. Washington, DC 20418, or may be exam- erages, § 170.3(n)(3) of this chapter. ined at the Office of the Federal Reg- Frozen dairy desserts, 10 Do. ister, 800 North Capitol Street, NW., § 170.3(n)(20) of this suite 700, Washington, DC 20408. chapter. Soft candy, 20 Do. (c) The ingredient is used to supply § 170.3(n)(38) of this up to 0.009 part of total L-cysteine per chapter. All other food cat- 4 Do. 100 parts of flour in dough as a dough egories. strengthener as defined in § 170.3(o)(6) 1 Parts per million. of this chapter in yeast-leavened baked 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 this section do not exist or have been (d) This regulation is issued prior to waived. a general evaluation of use of this in- gredient in order to affirm as GRAS [47 FR 29953, July 9, 1982] the specific use named. § 184.1265 Cuprous iodide. [42 FR 14653, Mar. 15, 1977, as amended at 49 (a) Cuprous iodide (copper (I) iodide, FR 5612, Feb. 14, 1984] CuI, CAS Reg. No. 7681–65–4) is a pure
476
VerDate 06
§ 184.1272 L-Cysteine human food ingredient is based upon monohydrochloride. the following current good manufac- (a) L-Cysteine monohydrochloride is turing practice conditions of use: the chemical L-2-amino-3- (1) The ingredient is used as a formu- mercaptopropanoic acid lation aid as defined in § 170.3(o)(14) of monohydrochloride monohydrate this chapter; as a processing aid as de- fined in § 170.3(o)(24) of this chapter; as (C3H7O2NS HCl H2O). (b) The ingredient meets the speci- a stabilizer and thickener as defined in fications of the ‘‘Food Chemicals § 170.3(o)(28) of this chapter; and as a Codex,’’ 3d Ed. (1981), pp. 92–93, which is surface-finishing agent as defined in incorporated by reference. Copies may § 170.3(o)(30) of this chapter. be obtained from the National Acad- (2) The ingredient is used in food at emy Press, 2101 Constitution Ave. NW., levels not to exceed current good man- Washington, DC 20418, or may be exam- ufacturing 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 to supply waived. up to 0.009 part of total L-cysteine per [48 FR 51909, Nov. 15, 1983] 100 parts of flour in dough as a dough strengthener as defined in § 170.3(o)(6) § 184.1278 Diacetyl. of this chapter in yeast-leavened baked (a) Diacetyl (C4H6O2, CAS Reg. No. goods and baking mixes as defined in 431–03–8) is a clear yellow to yellowish § 170.3(n)(1) of this chapter. green liquid with a strong pungent (d) This regulation is issued prior to odor. It is also known as 2,3- a general evaluation of use of this in- butanedione and is chemically syn- gredient in order to affirm as GRAS thesized from methyl ethyl ketone. It the specific use named. is miscible in water, glycerin, alcohol, [42 FR 14653, Mar. 15, 1977, as amended at 49 and ether, and in very dilute water so- FR 5612, Feb. 14, 1984] lution, it has a typical buttery odor and flavor. § 184.1277 Dextrin. (b) The ingredient meets the speci-
(a) Dextrin ((C6H10O5)n·H2O, CAS Reg. fications of the Food Chemicals Codex, 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
477
VerDate 06
this section do not exist or have been optimal for the action of the enzyme waived. until appropriate acid development is attained. The enzymes are then inac- [48 FR 51907, Nov. 15, 1983] tivated. The resulting product is con- § 184.1282 Dill and its derivatives. centrated or dried. (a) Dill (American or European) is (b) FDA is developing food-grade the herb and seeds from Anethum specifications for these enzyme-modi- graveolens L., and dill (Indian) is the fied ingredients in cooperation with herb and seeds from Anethum sowa, the National Academy of Sciences. In D.C. Its derivatives include essential the interim, the ingredients must be of oils, oleoresins, and natural extractives purity suitable for their intended use. obtained from these sources of dill. (c) In accordance with § 184.1(b)(1), (b) Dill oils meet the description and the ingredients are used in food with specifications of the ‘‘Food Chemicals no limitation other than current good Codex,’’ 4th ed. (1996), pp. 122–123, which manufacturing practice. The affirma- is incorporated by reference in accord- tion of these ingredients as generally ance with 5 U.S.C. 552(a) and 1 CFR recognized as safe (GRAS) as direct part 51. Copies are available from the human food ingredients is based upon National Academy Press, Box 285, 2101 the following current good manufac- Constitution Ave. NW., Washington, turing practice conditions of use: DC 20055 (Internet address ‘‘http:// (1) The ingredients are used as fla- www.nap.edu’’), or may be examined at voring agents and adjuvants as defined the Center for Food Safety and Applied in § 170.3(o)(12) of this chapter. Nutrition’s Library, Food and Drug Ad- (2) The ingredients are used in food ministration, 200 C St. SW., rm. 3321, at levels not to exceed current good Washington, DC, or at the Office of the manufacturing practice. Federal Register, 800 North Capitol St. (d) Prior sanctions for these ingredi- NW., suite 700, Washington, DC. ents different from the uses established (c) Dill and its derivatives are used as in this section do not exist or have flavoring agents and adjuvants as de- been waived. fined in § 170.3(o)(12) of this chapter. (d) The ingredients are used in food [52 FR 25976, July 10, 1987] at levels not to exceed good manufac- turing practice. § 184.1293 Ethyl alcohol. (e) [Reserved] (a) Ethyl alcohol (ethanol) is the (f) Prior sanctions for these ingredi- chemical C2H5OH. ents different from the uses established (b) The ingredient meets the speci- in this section do not exist or have fications of the ‘‘Food Chemicals been waived. Codex,’’ 4th ed. (1996), p. 136, which is [42 FR 14653, Mar. 15, 1977, as amended at 42 incorporated by reference in accord- FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, ance with 5 U.S.C. 552(a) and 1 CFR 1984; 64 FR 1760, Jan. 12, 1999] part 51. Copies are available from the National Academy Press, Box 285, 2101 § 184.1287 Enzyme-modified fats. Constitution Ave. NW., Washington, (a) Enzyme-modified refined beef fat, DC 20055 (Internet address ‘‘http:// enzyme-modified butterfat, and en- www.nap.edu’’), or may be examined at zyme-modified steam-rendered chicken the Center for Food Safety and Applied fat are prepared from refined beef fat; Nutrition’s Library, Food and Drug Ad- butterfat or milkfat; and steam-ren- ministration, 200 C St. SW., rm. 3321, dered chicken fat, respectively, with Washington, DC, or at the Office of the enzymes that are generally recognized Federal Register, 800 North Capitol St. as safe (GRAS). Enzyme-modified milk NW., suite 700, Washington, DC. powder may be prepared with GRAS (c) The ingredient is used as an anti- enzymes from reconstituted milk pow- microbial agent as defined in der, whole milk, condensed or con- § 170.3(o)(2) of this chapter on pizza centrated whole milk, evaporated crusts prior to final baking at levels milk, or milk powder. The lipolysis is not to exceed 2.0 percent by product maintained at a temperature that is weight.
478
VerDate 06
(d) This regulation is issued prior to § 184.1296 Ferric ammonium citrate. general evaluation of use of this ingre- (a) Ferric ammonium citrate (iron dient in order to affirm as GRAS the (III) ammonium citrate) is prepared by specific use named. the reaction of ferric hydroxide with [42 FR 14653, Mar. 15, 1977, as amended at 49 citric acid, followed by treatment with FR 5612, Feb. 14, 1984; 64 FR 1760, Jan. 12, ammonium hydroxide, evaporating, 1999] and drying. The resulting product oc- curs in two forms depending on the § 184.1295 Ethyl formate. stoichiometry of the initial reactants. (a) Ethyl formate (C3H6O2, CAS Reg. (1) Ferric ammonium citrate (iron No. 109–94–4) is also referred to as ethyl (III) ammonium citrate, CAS Reg. No. methanoate. It is an ester of formic 1332–98–5) is a complex salt of undeter- acid and is prepared by esterification mined structure composed of 16.5 to of formic acid with ethyl alcohol or by 18.5 percent iron, approximately 9 per- distillation of ethyl acetate and formic cent ammonia, and 65 percent citric acid in the presence of concentrated acid and occurs as reddish brown or sulfuric acid. Ethyl formate occurs garnet red scales or granules or as a naturally in some plant oils, fruits, and brownish-yellowish powder. juices but does not occur naturally in (2) Ferric ammonium citrate (iron the animal kingdom. (III) ammonium citrate, CAS Reg. No. (b) The ingredient meets the speci- 1333–00–2) is a complex salt of undeter- fications of the ‘‘Food Chemicals mined structure composed of 14.5 to 16 Codex,’’ 3d Ed. (1981), p. 376, which is in- percent iron, approximately 7.5 percent corporated by reference. Copies may be ammonia, and 75 percent citric acid obtained from the National Academy and occurs as thin transparent green Press, 2101 Constitution Ave. NW., scales, as granules, as a powder, or as Washington, DC 20418, or may be exam- transparent green crystals. ined at the Office of the Federal Reg- (b) The ingredients meet the speci- ister, 800 North Capitol Street, NW., fications of the Food Chemicals Codex, suite 700, Washington, DC 20408. 3d Ed. (1981), pp. 116–117 (Ferric ammo- (c) The ingredient is used as a fla- nium citrate, brown) and p. 117 (Ferric voring agent and adjuvant as defined in ammonium citrate, green), which is in- § 170.3(o)(12) of this chapter. corporated by reference. Copies are (d) The ingredient is used in food at available from the National Academy levels not to exceed good manufac- Press, 2101 Constitution Ave. NW., turing practice in accordance with Washington, DC 20418, or available for § 184.1(b)(1). Current good manufac- inspection at the Office of the Federal turing practice results in a maximum Register, 800 North Capitol Street, level, as served, of 0.05 percent in baked NW., suite 700, Washington, DC 20408. goods as defined in § 170.3(n)(1) of this (c) In accordance with § 184.1(b)(1), chapter; 0.04 percent in chewing gum as the ingredients are used in food as nu- defined in § 170.3(n)(6), hard candy as trient supplements as defined in defined in § 170.3(n)(25), and soft candy § 170.3(o)(20) of this chapter, with no as defined in § 170.3(n)(38) of this chap- limitation other than current good ter; 0.02 percent in frozen dairy des- manufacturing practice. The ingredi- serts as defined in § 170.3(n)(20) of this ents may also be used in infant formula chapter; 0.03 percent in gelatins, pud- in accordance with section 412(g) of the dings, and fillings as defined in Federal Food, Drug, and Cosmetic Act § 170.3(n)(22) of this chapter; and 0.01 (the act) (21 U.S.C. 350a(g)) or with reg- percent in all other food categories. ulations promulgated under section (e) Prior sanctions for ethyl formate 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). 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 been waived. [45 FR 22915, Apr. 4, 1980, as amended at 49 FR 5612, Feb. 14, 1984] [53 FR 16864, May 12, 1988]
479
VerDate 06
§ 184.1297 Ferric chloride. (d) Prior sanctions for this ingredient different from the uses established in (a) Ferric chloride (iron (III) chlo- this section do not exist or have been ride, FeC1 CAS Reg. No. 7705–08–0) 3, waived. may be prepared from iron and chlorine or from ferric oxide and hydrogen chlo- [53 FR 16865, May 12, 1988] ride. The pure material occurs as hydroscopic, hexagonal, dark crystals. § 184.1301 Ferric phosphate. Ferric chloride hexahydrate (iron (III) (a) Ferric phosphate (ferric chloride hexahydrate, FeC13. 6H20, CAS orthophosphate, iron (III) phosphate, Reg. No. 10025–77–1) is readily formed FePO4·xH2O, CAS Reg. No. 10045–86–0) is when ferric chloride is exposed to mois- an odorless, yellowish-white to buff- ture. colored powder and contains from one (b) The Food and Drug Administra- to four molecules of water of hydra- tion is developing food-grade specifica- tion. It is prepared by reaction of so- tions for ferric chloride in cooperation dium phosphate with ferric chloride or with the National Academy of ferric citrate. Sciences. In the interim, this ingre- (b) The ingredient meets the speci- dient must be of a purity suitable for fications of the Food Chemicals Codex, its intended use. 3d Ed. (1981), pp. 118–120, which is incor- (c) In accordance with § 184.1(b)(1) the porated by reference. Copies are avail- ingredient is used in food as a flavoring able from the National Academy Press, agent as defined in § 170.3(o)(12) of this 2101 Constitution Ave. NW., Wash- chapter, with no limitation other than ington, DC 20418, or available for in- current good manufacturing practice. spection at the Office of the Federal (d) Prior sanctions for this ingredient Register, 800 North Capitol Street, different from the uses established in NW., suite 700, Washington, DC 20408. this section do not exist or have been (c) In accordance with § 184.1(b)(1), waived. the ingredient is used in food as nutri- ent supplement as defined in [53 FR 16864, May 12, 1988] § 170.3(o)(20) of this chapter, with no limitation other than current good § 184.1298 Ferric citrate. manufacturing practice. The ingre- (a) Ferric citrate (iron (III) citrate, dient may also be used in infant for- C6H5FeO7, CAS Reg. No. 2338–05–8) is mula in accordance with section 412(g) prepared from reaction of citric acid of the Federal Food, Drug, and Cos- with ferric hydroxide. It is a compound metic Act (the act) (21 U.S.C. 350a(g)) of indefinite ratio of citric acid and or with regulations promulgated under iron. section 412(a)(2) of the act (21 U.S.C. (b) The Food and Drug Administra- 350a(a)(2)). tion is developing food-grade specifica- (d) Prior sanctions for this ingredient tions for ferric citrate in cooperation different from the uses established in with the National Academy of this section do not exist or have been Sciences. In the interim, this ingre- waived. dient must be of a purity suitable for its intended use. [53 FR 16865, May 12, 1988] (c) In accordance with § 184.1(b)(1), § 184.1304 Ferric pyrophosphate. the ingredient is used in food as a nu- trient supplement as defined in (a) Ferric pyrophosphate (iron (III) § 170.3(o)(20) of this chapter, with no pyrophosphate, Fe4(P207)3·xH2O, CAS limitation other than current good Reg. No. 10058–44–3) is a tan or yel- manufacturing practice. The ingre- lowish white colorless powder. It is pre- dient may also be used in infant for- pared by reacting sodium mula in accordance with section 412(g) pyrophosphate with ferric citrate. of the Federal Food, Drug, and Cos- (b) The ingredient meets the speci- metic Act (the act) (21 U.S.C. 350a(g)) fications of the Food Chemicals Codex, 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,
480
VerDate 06
2101 Constitution Ave. NW., Wash- (b) The Food and Drug Administra- ington, DC 20418, or available for in- tion is developing food-grade specifica- spection at the Office of the Federal tions for ferrous ascorbate in coopera- Register, 800 North Capitol Street, tion with the National Academy of NW., suite 700, Washington, DC 20408. Sciences. In the interim, this ingre- (c) In accordance with § 184.1(b)(1), dient must be of a purity suitable for the ingredient is used in food as a nu- its intended use. trient supplement as defined in (c) In accordance with § 184.1(b)(1), § 170.3(o)(20) of this chapter, with no the ingredient is used in food as a nu- limitation other than current good trient supplement as defined in manufacturing practice. The ingre- § 170.3(o)(20) of this chapter, with no dient may also be used in infant for- limitation other than current good mula in accordance with section 412(g) manufacturing practice. The ingre- of the Federal Food, Drug, and Cos- dient may also be used in infant for- metic Act (the act) (21 U.S.C. 350a(g)) mula in accordance with section 412(g) or with regulations promulgated under of the Federal Food, Drug, and Cos- section 412(a)(2) of the act (21 U.S.C. metic Act (the act) (21 U.S.C. 350a(g)) 350a(a)(2)). or with regulations promulgated under (d) Prior sanctions for this ingredient section 412(a)(2) of the act (21 U.S.C. different from the uses established in 350a(a)(2)). this section do not exist or have been (d) Prior sanctions for this ingredient waived. different from the uses established in [53 FR 16865, May 12, 1988; 53 FR 20939, June this section do not exist or have been 7, 1988] waived. [53 FR 16865, May 12, 1988] § 184.1307 Ferric sulfate. (a) Ferric sulfate (iron (III) sulfate, § 184.1307b Ferrous carbonate. Fe2(SO4)3, CAS Reg. No. 10028–22–5) is a (a) Ferrous carbonate (iron (II) car- yellow substance that may be prepared bonate, FeCO3, CAS Reg. No. 563–71–3) by oxidizing iron (II) sulfate or by is an odorless, white solid prepared by treating ferric oxide or ferric hydrox- treating solutions of iron (II) salts with ide with sulfuric acid. alkali carbonate salts. (b) The Food and Drug Administra- (b) The Food and Drug Administra- tion is developing food-grade specifica- tion is developing food-grade specifica- tions for ferric sulfate in cooperation tions for ferrous carbonate in coopera- with the National Academy of tion with the National Academy of Sciences. In the interim, this ingre- 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 fla- the ingredient is used in food as a nu- voring agent as defined in § 170.3(o)(12) trient supplement as defined in of this chapter, with no limitation § 170.3(o)(20) of this chapter, with no other than current good manufacturing limitation other than current good practice. manufacturing practice. The ingre- (d) Prior sanctions for this ingredient dient may also be used in infant for- different from the uses established in mula in accordance with section 412(g) this section do not exist or have been of the Federal Foods, Drug, and Cos- waived. metic Act (the act) (21 U.S.C. 350a(g)) [53 FR 16865, May 12, 1988] or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. § 184.1307a Ferrous ascorbate. 350a(a)(2)). (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- cent iron. [53 FR 16865, May 12, 1988]
481
VerDate 06
§ 184.1307c Ferrous citrate. in infant formula in accordance with (a) Ferrous citrate (iron (II) citrate, section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 (C6H6FeO7), CAS Reg. No. 23383–11–1) is a slightly colored powder or white U.S.C. 350a(g)), or with regulations pro- crystals. It is prepared from the reac- mulgated under section 412(a)(2) of the tion of sodium citrate with ferrous sul- act (21 U.S.C. 350a(a)(2)). fate or by direct action of citric acid on (d) Prior sanctions for this ingredient iron filings. different from the uses established in (b) The Food and Drug Administra- this section do not exist or have been tion is developing food-grade specifica- waived. tions for ferrous citrate in cooperation [53 FR 16866, May 12, 1988] with the National Academy of Sciences. In the interim, this ingre- § 184.1308 Ferrous gluconate. dient must be of a purity suitable for (a) Ferrous gluconate (iron (II) gluco- its intended use. nate dihydrate, C12H22FeO14·2H2O, CAS (c) In accordance with § 184.1(b)(1) the Reg. No. 6047-12-7) is a fine yellowish- ingredient is used in food as a nutrient gray or pale greenish-yellow powder or supplement as defined in § 170.3(o)(20) of granules. It is prepared by reacting hot this chapter, with no limitation other solutions of barium or calcium gluco- than current good manufacturing prac- nate with ferrous sulfate or by heating tice. The ingredient may also be used freshly prepared ferrous carbonate with in infant formula in accordance with gluconic acid in aqueous solution. section 412(g) of the Federal Food, (b) The ingredient meets the speci- Drug, and Cosmetic Act (the act) (21 fications of the Food Chemcials Codex, U.S.C. 350a(g)) or with regulations pro- 3d Ed. (1981), pp. 122–123, which is incor- mulgated under section 412(a)(2) of the porated by reference. Copies are avail- act (21 U.S.C. 350a(a)(2)). able from the National Academy Press, (d) Prior sanctions for this ingredient 2101 Constitution Avenue NW., Wash- different from the uses established in ington, DC 20418, or available for in- this section do not exist or have been spection at the Office of the Federal waived. Register, 800 North Capitol Street, [53 FR 16866, May 12, 1988] NW., suite 700, Washington, DC 20408. (c) In accordance with § 184.1(b)(1), § 184.1307d Ferrous fumarate. the ingredient is used in food as a nu- (a) Ferrous fumarate (iron (II) fuma- trient supplement as defined in § 170.3(o)(20) of this chapter, with no rate, (C4H2FeO4), CAS Reg. No. 141–01–5) is an odorless, reddish-orange to red- limitation other than current good dish-brown powder. It may contain soft manufacturing practice. The ingre- lumps that produce a yellow streak dient may also be used in infant for- when crushed. It is prepared by mula in accordance with section 412(g) admixing hot solutions of ferrous sul- of the Federal Food, Drug, and Cos- fate and sodium fumarate. metic Act (the act) (21 U.S.C. 350a(g)) (b) The ingredient meets the speci- or with regulations promulgated under fications of the Food Chemicals Codex, section 412(a)(2) of the act (21 U.S.C. 3d Ed. (1981), pp. 120–122, which is incor- 350a(a)(2)). porated by reference. Copies are avail- (d) Prior sanctions for this ingredient 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 C6H10FeO6, CAS Reg. No. 5905–52–2) in this chapter, with no limitation other the trihydrate form is a greenish-white than current good manufacturing prac- powder or crystalline mass. It is pre- tice. The ingredient may also be used pared by reacting calcium lactate or
482
VerDate 06
sodium lactate with ferrous sulfate, di- fate, dried), which is incorporated by rect reaction of lactic acid with iron reference. Copies are available from filings, reaction of ferrous chloride the National Academy Press, 2101 Con- with sodium lactate, or reaction of fer- stitution Ave., NW., Washington, DC rous sulfate with ammonium lactate. 20418, or available for inspection at the (b) The ingredient meets the speci- Office of Federal Register, 800 North fications of the Food Chemicals Codex, Capitol Street, NW., suite 700, Wash- 4th ed. (1996), pp. 154 to 155, which is in- ington, DC 20408. corporated by reference in accordance (c) In accordance with § 184.1(b)(1), with 5 U.S.C. 552(a) and 1 CFR part 51. the ingredients are used in food as nu- Copies are available from the National trient supplements as defined in Academy Press, 2101 Constitution Ave. § 170.3(o)(20) of this chapter and as a NW., Washington, DC 20418, or may be processing aid as defined in § 170.3(o)(24) examined at the Center for Food Safety of this chapter, with no limitation and Applied Nutrition’s library, 200 C other than current good manufacturing St. SW., rm. 3321, Washington, DC, or practice. The ingredients may also be at the Office of the Federal Register, used in infant formula in accordance 800 North Capitol St. NW., suite 700, with section 412(g) of the Federal Food, Washington, DC. Drug, and Cosmetic Act (the act) (21 (c) In accordance with § 184.1(b)(1), U.S.C. 350a(g)) or with regulations pro- the ingredient is used in food as a nu- mulgated under section 412(a)(2) of the trient supplement as defined in act (21 U.S.C. 350a(a)(2)). § 170.3(o)(20) of this chapter and as a (d) Prior sanctions for these ingredi- color fixative for ripe olives, with no ents different from the uses established other limitation other than current in this section do not exist or have good manufacturing practice. The in- been waived. gredient may also be used in infant for- mula in accordance with section 412(g) [53 FR 16866, May 12, 1988] of the Federal Food, Drug, and Cos- metic Act (the act) (21 U.S.C. 350a(g)) § 184.1316 Ficin. or with regulations promulgated under (a) Ficin (CAS Reg. No. 9001–33–6) is section 412(a)(2) of the act (21 U.S.C. an enzyme preparation obtained from 350a(a)(2)). the latex of species of the genus Ficus, (d) Prior sanctions for this ingredient which include a variety of tropical fig different from the uses established in trees. It is a white to off-white powder. this section do not exist or have been Its characterizing enzyme activity is waived. that of a peptide hydrolase (EC [53 FR 16866, May 12, 1988, as amended at 61 3.4.22.3). 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 (a) Ferrous sulfate heptahydrate Food Chemicals Codex, 3d ed. (1981), p. (iron (II) sulfate heptahydrate, 110, which is incorporated by reference FeSO4·7H2O, CAS Reg. No. 7782–63–0) is in accordance with 5 U.S.C. 552(a) and 1 prepared by the action of sulfuric acid CFR part 51. Copies are available from on iron. It occurs as pale, bluish-green the National Academy Press, 2101 Con- crystals or granules. Progressive heat- stitution Ave., NW., Washington, DC ing of ferrous sulfate heptahydrate pro- 20418, or may be examined at the Office duces ferrous sulfate (dried). Ferrous of Premarket Approval (HFS–200), Food sulfate (dried) consists primarily of fer- and Drug Administration, 200 C St., rous sulfate monohydrate (CAS Reg. SW., Washington, DC, and the Office of No. 17375–41–6) with varying amounts of the Federal Register, 800 North Capitol ferrous sulfate tetrahydrate (CAS Reg. St., NW., suite 700, Washington, DC. No. 20908–72–9) and occurs as a grayish- (c) In accordance with § 184.1(b)(1), white to buff-colored powder. the ingredient is used in food with no (b) The ingredients meet the speci- limitation other than current good fications of the Food Chemicals Codex, manufacturing practice. The affirma- 3d Ed. (1981), p. 123 (Ferrous sulfate tion of this ingredient as GRAS as a di- heptahydrate) and p. 124 (ferrous sul- rect food ingredient is based upon the
483
VerDate 06
following current good manufacturing dation of D-glucose with enzymes de- practice conditions of use: rived from these microorganisms. (1) The ingredient is used as an en- (b) The ingredient meets the speci- zyme as defined in § 170.3(o)(9) of this fications of the Food Chemicals Codex, chapter to hydrolyze proteins or 3d Ed. (1981), p. 134, which is incor- polypeptides. porated by reference. Copies are avail- (2) The ingredient is used in food at able from the National Academy Press, levels not to exceed current good man- 2101 Constitution Ave. NW., Wash- ufacturing practice. ington, DC 20418, or available for in- spection at the Office of the Federal [60 FR 32910, June 26, 1995] Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. § 184.1317 Garlic and its derivatives. (c) In accordance with § 184.1(b)(1), (a) Garlic is the fresh or dehydrated the ingredient is used in food with no bulb or cloves obtained from Allium limitation other than current good sativum, a genus of the lily family. Its manufacturing practice. The affirma- derivatives include essential oils, oleo- tion of this ingredient as generally rec- resins, and natural extractives ob- ognized as safe (GRAS) as a direct tained from garlic. human food ingredient is based upon (b) Garlic oil meets the specifications the following current good manufac- of the ‘‘Food Chemicals Codex,’’ 3d Ed. turing practice conditions of use: (1981), p. 132, which is incorporated by (1) The ingredient is used as a curing reference. Copies may be obtained from and pickling agent as defined in the National Academy Press, 2101 Con- § 170.3(o)(5) of this chapter, leavening stitution Ave. NW., Washington, DC agent as defined in § 170.3(o)(17) of this 20418, or may be examined at the Office chapter; pH control agent as defined in of the Federal Register, 800 North Cap- § 170.3(o)(23) of this chapter; and itol Street, NW., suite 700, Washington, sequestrant as defined in § 170.3(o)(26) of DC 20408. this chapter. (2) The ingredient is used at levels (c) Garlic and its derivatives are used not to exceed current good manufac- as flavoring agents and adjuvants as turing practice. defined in § 170.3(o)(12) of this chapter. (d) Prior sanctions for this ingredient (d) The ingredients are used in food different from the uses established in at levels not to exceed good manufac- this section do not exist or have been turing practice. waived. (e) [Reserved] (f) Prior sanctions for this ingredient [51 FR 33896, Sept. 24, 1986] different from the uses established in § 184.1321 Corn gluten. this section do not exist or have been waived. (a) Corn gluten (CAS Reg. No. 66071– 96–3), also known as corn gluten meal, [42 FR 14653, Mar. 15, 1977, as amended at 42 is the principal protein component of FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, corn endosperm. It consists mainly of 1984] zein and glutelin. Corn gluten is a by- product of the wet milling of corn for § 184.1318 Glucono delta-lactone. starch. The gluten fraction is washed (a) Glucono delta-lactone (C6H10O6, to remove residual water soluble pro- CAS Reg. No. 90–80–2), also called D- teins. Corn gluten is also produced as a gluconic acid delta-lactone or D- byproduct during the conversion of the glucono-1,5-lactone, is the cyclic 1,5- starch in whole or various fractions of intramolecular ester of D-gluconic dry milled corn to corn syrups. acid. It is prepared by direct crys- (b) FDA is developing food-grade tallization from the aqueous solution specifications for corn gluten in co- of gluconic acid. Gluconic acid may be operation with the National Academy produced by the oxidation of D-glucose of Sciences. In the interim, the ingre- with bromine water, by the oxidation dient must be of a purity suitable for of D-glucose by microorganisms that its intended use. are nonpathogenic and nontoxicogenic (c) In accordance with § 184.1(b)(1), to man or other animals, or by the oxi- the ingredient is used in food with no
484
VerDate 06
limitation other than current good texturizing agent as defined in manufacturing practice. The affirma- § 170.3(o)(32) of 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 nutri- this section do not exist or have been ent supplement as defined in waived. § 170.3(o)(20) of this chapter and a texturizer as defined in § 170.3(o)(32) of [50 FR 8998, Mar. 6, 1985] this chapter. § 184.1323 Glyceryl monooleate. (2) The ingredient is used in food at levels not to exceed current good man- (a) Glyceryl monooleate is prepared ufacturing practice. by esterification of commerical oleic (d) Prior sanctions for this ingredient acid that is derived either from edible different from the uses established in sources or from tall oil fatty acids this section do not exist or have been meeting the requirements of § 172.862 of waived. this chapter. It contains glyceryl monooleate (C21H40O4, CAS Reg. No. [50 FR 8998, Mar. 6, 1985] 25496–72–4) and glyceryl esters of fatty acids present in commercial oleic acid. § 184.1322 Wheat gluten. (b) FDA is developing food-grade (a) Wheat gluten (CAS Reg. No. 8002– specifications for glyceryl monooleate 80–0) is the principal protein compo- in cooperation with the National Acad- nent of wheat and consists mainly of emy of Sciences. In the interim, this gliadin and glutenin. Wheat gluten is ingredient must be of a purity suitable obtained by hydrating wheat flour and for its intended use. mechanically working the sticky mass (c) In accordance with § 184.1(b)(1), to separate the wheat gluten from the the ingredient is used in food with no starch and other flour components. limitation other than current good Vital gluten is dried gluten that has re- manufacturing practice. The affirma- tained its elastic properties. tion of this ingredient as generally rec- (b) FDA is developing food-grade ognized as safe (GRAS) as a direct specifications for wheat gluten in co- human food ingredient is based upon operation with the National Academy the following current good manufac- of Sciences. In the interim, the ingre- turing practice conditions of use: dient must be of a purity suitable for (1) The ingredient is used as a fla- its intended use. voring agent and adjuvant as defined in (c) In accordance with § 184.1(b)(1), § 170.3(o)(12) of this chapter and as a the ingredient is used in food with no solvent and vehicle as defined in limitation other than current good § 170.3(o)(27) of this chapter. manufacturing practice. The affirma- (2) The ingredient is used in the fol- 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]
485
VerDate 06
§ 184.1324 Glyceryl monostearate. direct human food ingredient is based (a) Glyceryl monostearate, also upon the following current good manu- known as monostearin, is a mixture of facturing practice conditions of use: (1) The ingredient is used as a formu- variable proportions of glyceryl mono- lation aid, as defined in § 170.3(o)(14) of stearate (C H O CAS Reg. No. 31566– 21 42 4, this chapter. 31–1), glyceryl monopalmitate (2) The ingredient is used in excipient (C H O CAS Reg. No. 26657–96–5) and 19 38 4, formulations for use in tablets at levels glyceryl esters of fatty acids present in not to exceed good manufacturing commercial stearic acid. Glyceryl practice. monostearate is prepared by glycerolysis of certain fats or oils that [52 FR 42430, Nov. 5, 1987] are derived from edible sources or by esterification, with glycerin, of stearic § 184.1329 Glyceryl palmitostearate. acid that is derived from edible (a) Glyceryl palmitostearate is a sources. mixture of mono-, di-, and triglyceryl (b) FDA is developing food-grade esters of palmitic and stearic acids specifications for glyceryl monostea- made from glycerin, palmitic acid, and rate in cooperation with the National stearic acid. Academy of Sciences. In the interim, (b) The ingredient meets the fol- this ingredient must be of a purity lowing specifications: suitable for its intended use. (1) The substance is a mixture of (c) In accordance with § 184.1(b)(1), mono-, di-, and triglycerides of pal- the ingredient is used in food with no mitic acid and stearic acid. limitation other than current good (2) Heavy metals (as lead): Not more manufacturing practice. than 10 parts per million. (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 not exist or have limitation other than current good been waived. manufacturing practice. The affirma- tion of this ingredient as generally rec- [54 FR 7403 Feb. 21, 1989] ognized as safe (GRAS) as a direct § 184.1328 Glyceryl behenate. human food ingredient is based upon the following current good manufac- (a) Glyceryl behenate is a mixture of turing practice conditions of use: glyceryl esters of behenic acid made (1) The ingredient is used as a formu- from glycerin and behenic acid (a satu- lation aid, as defined in § 170.3(o)(14) of rated C22 fatty acid). The mixture con- this chapter. tains predominately glyceryl (2) The ingredient is used in excipient dibehenate. formulations for use in tablets at levels (b) The ingredient meets the fol- not to exceed good manufacturing lowing specifications: practice. (1) 10 to 20 percent monoglyceride, 47 to 59 percent diglyceride, 26 to 38 per- [60 FR 63621, Dec. 12, 1995] cent triglyceride, and not more than 2.5 percent free fatty acids. § 184.1330 Acacia (gum arabic). (2) Behenic acid. Between 80 and 90 (a) Acacia (gum arabic) is the dried percent of the total fatty acid content. gummy exudate from stems and (3) Acid value. Not more than 4. branches of trees of various species of (4) Saponification value. Between 145 the genus Acacia, family Leguminosae. and 165. (b) The ingredient meets the speci- (5) Iodine number. Not more than 3. fications of the ‘‘Food Chemicals (6) Heavy metals (as Pb). Not more Codex,’’ 3d Ed. (1981), p. 7, which is in- than 10 parts per million. corporated by reference. Copies may be (c) In accordance with § 184.1(b)(1) of obtained from the National Academy this chapter, the ingredient is used in Press, 2101 Constitution Ave. NW., food with no limitation other than cur- Washington, DC 20418, or may be exam- rent good manufacturing practice. The ined at the Office of the Federal Reg- affirmation of this ingredient is gen- ister, 800 North Capitol Street, NW., erally recognized as safe (GRAS) as a suite 700, Washington, DC 20408.
486
VerDate 06
(c) The ingredient is used in food under the following conditions:
MAXIMUM USAGE LEVELS PERMITTED
Food (as served) Percent Function
Beverages and beverage bases, § 170.3(n)(3) of 2.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; this 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 chap- ter; formulation aid, § 170.3(o)(14) of this chapter; hu- mectant, § 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 12.4 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer chapter. and thickener, § 170.3(o)(28) of this chapter; surface-fin- ishing agent, § 170.3(o)(30) of this chapter. Dairy product analogs, § 170.3(n)(10) of this chap- 1.3 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer ter. and thickener, § 170.3(o)(28) of this chapter. Fats and oils, § 170.3(n)(12) of this chapter ...... 1.5 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Gelatins, puddings, and fillings, § 170.3(n)(22) of 2.5 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. Hard candy and cough drops, § 170.3(n)(25) of this 46.5 Flavoring agent and adjuvant, § 170.3(o)(12) of this chap- chapter. ter; formulation aid, § 170.3(o)(14) of this chapter. Nuts and nut products, § 170.3(n)(32) of this chap- 8.3 Formulation aid, § 170.3(o)(14) of this chapter; surface-fin- ter. 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, § 1 170.3(o)(16) of this chapter; stabilizer and thickener, § 1 170.3(o)(28) of this chapter; surface-finishing agent, § 1 170.3(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, § 1 170.3(o)(32) of this chapter.
(d) [Reserved] (1) Viscosity of a 1-percent solution. (e) Prior sanctions for this ingredient Not less than the minimum or within different from the uses established in the range claimed by the vendor. this section do not exist or have been (2) Limits of impurities—(i) Arsenic (as waived. AL). Not more than 3 parts per million (0.0003 percent); [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, (ii) Ash (acid-insoluble). Not more 1983; 53 FR 5766, Feb. 26, 1988] than 1.75 percent; (iii) Ash (total). Not more than 6.0 § 184.1333 Gum ghatti. percent; (a) Gum ghatti (Indian gum) is an (iv) Heavy metals (as Pb). Not more exudate from wounds in the bark of than 40 parts per million (0.004 per- Anogeissus latifolia, a large tree found cent); and in the dry deciduous forests of India (v) Lead. Not more than 10 parts per and Ceylon. million (0.001 percent). (b) The ingredient complies with the (3) Loss on drying. Not more than 14 following specifications: percent dried at 105 °C for 5 hours.
487
VerDate 06
(4) Identification test. Add 0.2 ml of di- 800 North Capitol Street, NW., suite luted lead acetate as outlined in ‘‘Offi- 700, Washington, DC 20408), to 5 ml of a cial Methods of Analysis of the Asso- cold 1-in-100 aqueous solution of the ciation of Official Analytical Chem- gum. An immediate, voluminous, ists,’’ 13th Ed. (1980), section 31.178(b), opaque precipitate indicates acacia. A p. 529, under ‘‘Dilute Basic Lead Ace- small precipitate or clear solution tate Standard Solution,’’ which is in- which produces an opaque flocculent corporated by reference (copies are precipitate upon the additon of 1 ml of available from the Association of Offi- 3 N ammonimum hydroxide indicates cial Analytical Chemists, P.O. Box 540, gum ghatti. Benjamin Franklin Station, Wash- ington, DC 20044, or may be examined (c) The ingredient is used in food at the Office of the Federal Register, under the following conditions: Maximum Usage Levels Permitted
Food (as served) Percent Function
Beverages and beverage bases, nonalcoholic, § 1 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.
488
VerDate 06
(d) [Reserved] evergreen tree, with lesser quantities (e) Prior sanctions for this ingredient of seed coat and germ. different from the uses established in (b) The ingredient meets the speci- this section do not exist or have been fications of the ‘‘Food Chemicals waived. Codex,’’ 3d Ed. (1981), pp. 174–175, which is incorporated by reference. Copies [42 FR 14653, Mar. 15, 1977, as amended at 42 may be obtained from the National FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, Academy Press, 2101 Constitution Ave. 1984] NW., Washington, DC 20418, or may be examined at the Office of the Federal § 184.1343 Locust (carob) bean gum. Register, 800 North Capitol Street, (a) Locust (carob) bean gum is pri- NW., suite 700, Washington, DC 20408. marily the macerated endosperm of the (c) The ingredient is used at levels seed of the locust (carob) bean tree, not to exceed the following maximum Ceratonia siliqua (Linne), a leguminous levels:
MAXIMUM USAGE LEVELS PERMITTED
Food (as served) Percent Function
Baked goods and baking mixes, § 170.3(n)(1) of this 0.15 Stabilizer and thickener, § 170.3(o)(28) of this chapter. chapter. Beverages and beverage bases, nonalcoholic, .25 Do. § 170.3(n)(3) of this chapter. Cheeses, § 170.3(n)(5) of this chapter ...... 8 Do. Gelatins, puddings, and fillings, § 170.3(n)(22) of this .75 Do. chapter. Jams and jellies, commercial, § 170.3(n)(28) of this .75 Do. chapter. All other food categories ...... 5 Do.
(d) [Reserved] of trees of various species of the genus (e) Prior sanctions for this ingredient Sterculia. different from the uses established in (b) The ingredient meets the speci- this regulation do not exist or have fications of the ‘‘Food Chemicals been waived. Codex,’’ 3d Ed. (1981), p. 157, which is 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.
489
VerDate 06
(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:
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] human food ingredient is based upon (e) Prior sanctions for this ingredient the following current good manufac- different from the uses established in turing practice conditions of use: this section do not exist or have been (1) The ingredient is used as a proc- waived. essing aid as defined in § 170.3(o)(24) of this chapter. [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, (2) The ingredient is used in food at 1984] levels not to exceed current good man- ufacturing practice. § 184.1355 Helium. (d) Prior sanctions for this ingredient different from the uses established in (a) Helium (empirical formula He, this section do not exist or have been CAS Reg. No. 7440–59–7) is a colorless, waived. odorless, flavorless, nonflammable, inert gas. It is lighter than air and is [48 FR 57270, Dec. 29, 1983] produced by the liquefaction and puri- fication of natural gas. § 184.1366 Hydrogen peroxide.
(b) The Food and Drug Administra- (a) Hydrogen peroxide (H2O2, CAS tion is developing food-grade specifica- Reg. No. 7722–84–1) is also referred to as tions for helium in cooperation with hydrogen dioxide. It is made by the the National Academy of Sciences. In electrolytic oxidation of sulfuric acid the interim, the ingredient must be of or a sulfate to persulfuric acid or a a purity suitable for its intended use. persulfuric acid salt with subsequent (c) In accordance with § 184.1(b)(1), hydrolysis and distillation of the hy- the ingredient is used in food with no drogen peroxide formed; by decomposi- limitations other than current good tion of barium peroxide with sulfuric manufacturing practice. The affirma- or phosphoric acid; by hydrogen reduc- tion of this ingredient as generally rec- tion of 2-ethylanthraquinone, followed ognized as safe (GRAS) as a direct by oxidation with air, to regenerate
490
VerDate 06
the quinone and produce hydrogen per- 3d ed. (1981), pp. 146–147,1 which is incor- oxide; or by electrical discharge porated by reference. through a mixture of hydrogen, oxy- (c) In accordance with § 184.1(b)(2), gen, and water vapor. the ingredient is used to treat food (b) The ingredient meets the speci- only within the following specific limi- fications of the Food Chemicals Codex, tations:
Maximum treatment Food level in food (percent) Functional use
Milk, intended for use during the cheesemaking 0.05 ...... Antimicrobial agent as defined in § 170.3 (o)(2) of process as permitted in the appropriate stand- this chapter ards of identity for cheese and related cheese products under part 133 of this chapter. Whey, during the preparation of modified whey by 0.04 ...... do. electrodialysis methods. Dried eggs, dried egg whites, and dried egg yolks Amount sufficient for Oxidizing and reducing agent as defined in § 170.3 as in §§ 160.105, 160.145, and 160.185 of this the purpose. (o)(22) of this chapter chapter. Tripe ...... do...... Bleaching agent. Beef feet ...... Amount sufficient for Bleaching agent. the purpose. (Hy- drogen peroxide may be in the form of a compound salt, sodium carbonate peroxide). Herring ...... Amount sufficient for do. the purpose. Wine ...... do...... Oxidizing and reducing agent as defined in § 170.3 (o)(22) of this chapter. Starch ...... 0.15 ...... Antimicrobial agent as defined in §170.3 (o)(2) of this chapter, to produce thermophile-free starch; Remove sulfur dioxide from starch slurry following steeping and grinding operations of corn 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- aqueous (0.2 percent sulfur dioxide) ex- moved by appropriate physical and tract of corn kernels by precipitation chemical means during the processing and hydrolysis of crude phytate. of food where it has been used accord- (b) The ingredient meets the speci- ing to paragraph (c) of this section. fications of the Food Chemicals Codex, (e) Prior sanctions for this ingredient 3d Ed. (1981), p. 150, which is incor- different from the uses established in porated by reference. Copies are avail- this section do not exist or have been able from the National Academy Press, waived. 2101 Constitution Ave. NW., Wash- [46 FR 44439, Sept. 4, 1981, as amended at 51 ington, DC 20418, or available for in- FR 27172, July 30, 1986] spection at the Office of the Federal Register, 800 North Capitol Street, § 184.1370 Inositol. NW., suite 700, Washington, DC 20408. (a) Inositol, or myo-inositol (C6H12O6, (c) In accordance with § 184.1(b)(1), CAS Reg. No. 87–89–8), is cis-1,2,3,5- the ingredient is used in food with no trans-4,6-cyclohexanehexol. It occurs limitations other than current good naturally and is prepared from an
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.
491
VerDate 06
manufacturing practice. The affirma- tion of this ingredient as generally rec- tion of this ingredient as generally rec- ognized as safe (GRAS) as a direct ognized as safe (GRAS) as a direct human food ingredient is based upon human food ingredient is based upon the following current good manufac- the following current good manufac- turing practice conditions of use: turing practice conditions of use: (1) The ingredient is used as an en- (1) The ingredient is used as a nutri- zyme, as defined in § 170.3(o)(9) of this ent supplement as defined in chapter, to convert glucose to fructose. § 170.3(o)(20) of this chapter. (2) The ingredient is used in high (2) The ingredient is used in special fructose corn syrup, at levels not to ex- dietary foods as defined in part 105 of ceed current good manufacturing prac- this chapter at levels not to exceed tice. current good manufacturing practice. [48 FR 5720, Feb. 8, 1983, as amended at 61 FR It may also be used in infant formula 43450, Aug. 23, 1996] in accordance with section 412(g) of the Act, or with regulations promulgated § 184.1375 Iron, elemental. under section 412(a)(2) of the Act. (a) Iron, elemental (CAS Reg. No. (d) Prior sanctions for this ingredient 7439–89–6) is metallic iron obtained by different from the uses established by any of the following processes: reduced this section do not exist or have been iron, electrolytic iron, and carbonyl waived. iron. [47 FR 38278, Aug. 31, 1982] (1) Reduced iron is prepared by react- ing ground ferric oxide with hydrogen § 184.1372 Insoluble glucose isomerase or carbon monoxide at an elevated enzyme preparations. temperature. The process results in a (a) Insoluble glucose isomerase en- grayish-black powder, all of which zyme preparations are used in the pro- should pass through a 100-mesh sieve. duction of high fructose corn syrup de- It is lusterless or has not more than a scribed in § 184.1866. They are derived slight luster. When viewed under a mi- from recognized species of precisely croscope, it appears as an amorphous classified nonpathogenic and powder free from particles having a nontoxicogenic microorganisms, in- crystalline structure. It is stable in dry cluding Streptomyces rubiginosus, air. Actinoplanes missouriensis, Streptomyces (2) Electrolytic iron is prepared by olivaceus, Streptomyces olivochromogenes, electrodeposition. It is an amorphous, and Bacillus coagulans, that have been lusterless, grayish-black powder. It is grown in a pure culture fermentation stable in dry air. 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
492
VerDate 06
§ 170.3(o)(20) of this chapter, with no § 184.1387 Lactase enzyme preparation limitation other than current good from Candida pseudotropicalis. manufacturing practice. The ingre- (a) This enzyme preparation is de- dient may also be used in accordance rived from the nonpathogenic, with section 412(g) of the Federal Food, nontoxicogenic yeast C. Drug, and Cosmetic Act (the act) (21 pseudotropicalis. It contains the enzyme U.S.C. 350a(g)) or with regulations pro- lactase (β-D-galactoside mulgated under section 412(a)(2) of the galactohydrolase, EC 3.2.1.23), which act (21 U.S.C. 350a(2)). converts lactose to glucose and galac- (d) Prior sanctions for this ingredient tose. It is prepared from yeast that has different from the uses established in been grown by a pure culture fermenta- this section do not exist or have been tion process. waived. (b) The ingredient meets the general [53 FR 16867, May 12, 1988] requirements and additional require- ments for enzyme preparations in the § 184.1386 Isopropyl citrate. Food Chemicals Codex, 3d ed. (1981), pp. 107–110, which are incorporated by ref- (a) Isopropyl citrate is a mixture of erence in accordance with 5 U.S.C. the mono-, di-, and triisopropyl esters 552(a) and 1 CFR part 51. Copies are 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. ufacturing practice. Current good man- (2) The ingredient is used in mar- ufacturing practice is limited to use of garine in accordance with § 166.110 of this ingredient to reduce the lactose this chapter; in nonalcoholic beverages content in milk and milk-derived food as defined in § 170.3(n)(3) of this chap- products where food standards do not ter; and in fats and oils as defined in preclude such use. § 170.3(n)(12) of this chapter at levels not to exceed current good manufac- [61 FR 7704, Feb. 29, 1996] turing practice. § 184.1388 Lactase enzyme preparation (d) Prior sanctions for this ingredient from Kluyveromyces lactis. different from the uses established in (a) This enzyme preparation is de- this section, or different from those set rived from the nonpathogenic, forth in part 181 of this chapter, do not nontoxicogenic yeast Kluyveromyces exist or have been waived. lactis (previously named Saccharomyces [59 FR 63896, Dec. 12, 1994] lactis). It contains the enzyme Β-
493
VerDate 06
galactoside galactohydrase (CAS Reg. porated by reference. Copies are avail- No. CBS 683), which converts lactose to able from the National Academy Press, glucose and galactose. It is prepared 2101 Constitution Ave. NW., Wash- from yeast that has been grown in a ington, DC 20418, or available for in- pure culture fermentation and by using spection at the Office of the Federal materials that are generally recognized Register, 800 North Capitol Street, as safe or are food additives that have NW., suite 700, Washington, DC 20408. been approved for this use by the Food (c) In accordance with § 184.1(b)(1), and Drug Administration. the ingredient is used in food with no (b) The ingredient meets the general limitation other than current good and additional requirements for en- manufacturing practice. zyme preparations in the Food Chemi- (d) Prior sanctions for this ingredient cals Codex, 3d Ed. (1981), p. 107–110, different from the uses established in which is incorporated by reference. this section do not exist or have been Copies are available from the National waived. Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or avail- [48 FR 51150, Nov. 7, 1983] able for inspection at the Office of the Federal Register, 800 North Capitol § 184.1408 Licorice and licorice deriva- Street, NW., suite 700, Washington, DC tives. 20408. (a)(1) Licorice (glycyrrhiza) root is (c) In accordance with § 184.1(b)(1), the dried and ground rhizome and root the ingredient is used in food with no portions of Glycyrrhiza glabra or other limitation other than current good species of Glycyrrhiza. Licorice extract manufacturing practice. The affirma- is that portion of the licorice root that tion of this ingredient as generally rec- is, after maceration, extracted by boil- ognized as safe as a direct human food ing water. The extract can be further ingredient is based upon the following purified by filtration and by treatment current good manufacturing practice with acids and ethyl alcohol. Licorice conditions of use: extract is sold as a liquid, paste (1) The ingredient is used as an en- (‘‘block’’), or spray-dried powder. zyme as defined in §170.3(o)(9) of this (2) Ammoniated glycyrrhizin is pre- chapter to convert lactose to glucose pared from the water extract of lico- and galactose. rice root by acid precipitation followed (2) The ingredient is used in food at by neutralization with dilute ammonia. levels not to exceed current good man- Monoammonium glycyrrhizinate ufacturing practice. Current good man- (C42H61O16NH45H2O, CAS Reg. No. 1407– ufacturing practice is to use this ingre- 03–0) is prepared from ammoniated 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 (a) Commercial lecithin is a natu- of Official Analytical Chemists, 13th rally occurring mixture of the Ed., §§ 19.136–19.140, which is incor- phosphatides of choline, ethanolamine, porated by reference, or by methods and inositol, with smaller amounts of 19.CO1 through 19.CO4 in the Journal of othe lipids. It is isolated as a gum fol- the Association of Official Analytical lowing hydration of solvent-extracted Chemists, 65:471–472 (1982), which are soy, safflower, or corn oils. Lecithin is also incorporated by reference. Copies bleached, if desired, by hydrogen per- of all of these methods are available oxide and benzoyl peroxide and dried from the Association of Official Ana- by heating. lytical Chemists, 2200 Wilson Blvd., (b) The ingredient meets the speci- Suite 400, Arlington, VA 22201–3301, or fications of the Food Chemicals Codex, available for inspection at the Office of 3d Ed. (1981), pp. 166–167, which is incor- the Federal Register, 800 North Capitol
494
VerDate 06
Street, NW., suite 700, Washington, DC basis as determined by the method in 20408. the Food Chemicals Codex, 3d Ed. (2) Ash. Not more than 9.5 percent for (1981), p. 466, which is incorporated by licorice, 2.5 percent for ammoniated reference. glycyrrhizin, and 0.5 percent for (4) Heavy metals (as Pb). Not more monoammonium glycyrrhizinate on an than 40 parts per million as determined anhydrous basis as determined by the by method II in the Food Chemicals method in the Food Chemicals Codex, Codex, 3d Ed. (1981), p. 512, which is in- 3d Ed. (1981), p. 466, which is incor- corporated by reference. porated by reference. Copies are avail- (5) Arsenic (As). Not more than 3 parts able from the National Academy Press, per million as determined by the meth- 2101 Constitution Ave. NW., Wash- od in the Food Chemicals Codex. 3d Ed. ington, DC 20418, or available for in- (1981), p. 464, which is incorporated by spection at the Office of the Federal reference. Register, 800 North Capitol Street, (c) In accordance with § 184.1(b)(2), NW., suite 700, Washington, DC 20408. these ingredients are used in food only (3) Acid unsoluble ash. Not more than within the following specific limita- 2.5 percent for licorice on an anhydrous 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 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. [50 FR 21044, May 22, 1985, as amended at 54 (c) In accordance with § 184.1(b)(1), FR 24899, June 12, 1989] the ingredient is used in food with no limitation other than current good § 184.1409 Ground limestone. manufacturing practice. (a) Ground limestone consists essen- (d) Prior sanctions for this ingredient tially (not less than 94 percent) of cal- different from the uses established in cium carbonate (CaCO3) and is prepared this section do not exist or have been by the crushing, grinding, and waived. classifying of naturally occurring lime- stone. [48 FR 52442, Nov. 18, 1983] (b) The ingredient meets the speci- § 184.1415 Animal lipase. fications of the Food Chemicals Codex, 3d Ed. (1981), p. 173, which is incor- (a) Animal lipase (CAS Reg. No. 9001– porated by reference. Copies are avail- 62–1) is an enzyme preparation obtained able from the National Academy Press, from edible forestomach tissue of 2101 Constitution Ave. NW., Wash- calves, kids, or lambs, or from animal
495
VerDate 06
pancreatic tissue. The enzyme prepara- porated by reference in accordance tion may be produced as a tissue prepa- with 5 U.S.C. 552(a) and 1 CFR part 51. ration or as an aqueous extract. Its Copies are available from the National characterizing enzyme activity is that Academy Press, 2101 Constitution Ave. of a triacylglycerol hydrolase (EC NW., Washington, DC 20418, or may be 3.1.1.3). examined at the Center for Food Safety (b) The ingredient meets the general and Applied Nutrition’s Library, 200 C requirements and additional require- St. SW., rm. 3321, Washington, DC, or ments for enzyme preparations in the the Office of the Federal Register, 800 Food Chemicals Codex, 3d ed. (1981), p. North Capitol St. NW., suite 700, Wash- 110, which is incorporated by reference ington, DC. in accordance with 5 U.S.C. 552(a) and 1 (c) In accordance with § 184.1(b)(1), CFR part 51. Copies are available from the ingredient is used in food with no the National Academy Press, 2101 Con- limitation other than current good stitution Ave., NW., Washington, DC manufacturing practice. The affirma- 20418, or may be examined at the Office tion of this ingredient as generally rec- of Premarket Approval (HFS–200), Food ognized as safe as a direct human food and Drug Administration, 200 C St., ingredient is based upon the following 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
496
VerDate 06
the following current good manufac- (2) The ingredient is used in foods at turing practice conditions of use: levels not to exceed current good man- (1) The ingredient is used as an ufacturing practice. The ingredient anticaking and free-flow agent as de- also may be used in infant formula in fined in § 170.3(o)(1) of this chapter; a accordance with section 412(g) of the flour treating agent as defined in Federal Food, Drug, and Cosmetic Act § 170.3(o)(13) of this chapter; a lubricant (the act) or with regulations promul- and release agent as defined in gated under section 412(a)(2) of the act. § 170.3(o)(18) of this chapter; a nutrient (d) Prior sanctions for this ingredient supplement as defined in § 170.3(o)(20) of different from the uses established in this chapter; a pH control agent as de- this section do not exist or have been fined in § 170.3(o)(23) of this chapter; a waived. processing aid as defined in § 170.3(o)(24) of this chapter; and a synergist as de- [50 FR 13559, Apr. 5, 1985; 50 FR 16080, Apr. 24, fined in § 170.3(o)(31) of this chapter. 1985] (2) The ingredient is used in foods at § 184.1428 Magnesium hydroxide. levels not to exceed current good man- ufacturing practice. (a) Magnesium hydroxide (Mg(OH)2, (d) Prior sanctions for this ingredient CAS Reg. No. 1309–42–8) occurs natu- different from the uses established in rally as the colorless, crystalline min- this section do not exist or have been eral brucite. It is prepared as a white waived. precipitate by the addition of sodium hydroxide to a water soluble magne- [50 FR 13558, Apr. 5, 1985; 50 FR 16080, Apr. 24, sium salt or by hydration of reactive 1985] grades of magnesium oxide. § 184.1426 Magnesium chloride. (b) The ingredient meets the speci- fications of the Food Chemicals Codex, (a) Magnesium chloride (MgC1 ·6H O, 2 2 3d Ed. (1981), p. 178, which is incor- CAS Reg. No. 7786–30–3) is a colorless, porated by reference. Copies are avail- deliquescent, crystalline material that able from the National Academy Press, occurs naturally as the mineral 2101 Constitution Ave. NW., Wash- bischofite. It is prepared by dissolving ington, DC 20418, or available for in- magnesium oxide, hydroxide, or car- spection at the Office of the Federal bonate in aqueous hydrochloric acid so- Register, 800 North Capitol Street, lution and crystallizing out magnesium NW., suite 700, Washington, DC 20408. chloride hexahydrate. (c) In accordance with § 184.1(b)(1), (b) The ingredient meets the speci- the ingredient is used in food with no fications of the Food Chemicals Codex, limitation other than current good 3d Ed. (1981), p. 177, 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, NW., suite 700, Washington, DC 20408. (1) The ingredient is used as a nutri- (c) In accordance with § 184.1(b)(1), ent supplement as defined in the ingredient is used in food with no § 170.3(o)(20) of this chapter; a pH con- limitation other than current good 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 [50 FR 13559, Apr. 5, 1985, as amended at 64 § 170.3(o)(20) of this chapter. FR 405, Jan. 5, 1999]
497
VerDate 06
§ 184.1431 Magnesium oxide. this section do not exist or have been waived. (a) Magnesium oxide (MgO, CAS Reg. No. 1309–48–4) occurs naturally as the [50 FR 13559, Apr. 5, 1985] colorless, crystalline mineral periclase. It is produced either as a bulky white § 184.1434 Magnesium phosphate. powder (light) or a relatively dense (a) Magnesium phosphate includes white powder (heavy) by heating mag- both magnesium phosphate, dibasic, nesium hydroxide or carbonate. Heat- and magnesium phosphate, tribasic. ing these magnesium salts under mod- Magnesium phosphate, dibasic erate conditions (400° to 900 °C for a few (MgHPO4·3H2O, CAS Reg. No. 7782–0975– hours) produces light magnesium 094) occurs naturally as the white, oxide. Heating the salts under more crystalline mineral newberyite. It is rigorous conditions (1200 °C for 12 prepared commercially as a precipitate hours) produces heavy magnesium formed by treating a solution of mag- oxide. Light magnesium oxide is con- nesium sulfate with disodium phos- verted to heavy magnesium oxide by phate under controlled conditions. sustained heating at high tempera- Magnesium phosphate, tribasic tures. (Mg3(PO4)2·xH2O, CAS Reg. No. 7727– (b) The ingredient meets the speci- 0987–091) may contain 4, 5, or 8 mol- fications of the Food Chemicals Codex, ecules of water of hydration. It is pro- 3d Ed. (1981), p. 178, which is incor- duced as a precipitate from a solution porated by reference. Copies are avail- of magnesite with phosphoric acid. able from the National Academy Press, (b) Magnesium phosphate, dibasic, 2101 Constitution Ave. NW., Wash- meets the specifications of the Food ington, DC 20418, or available for in- Chemicals Codex, 3d Ed. (1981), p. 179, spection at the Office of the Federal which is incorporated by reference. Register, 800 North Capitol Street, Magnesium phosphate, tribasic, meets NW., suite 700, Washington, DC 20408. the specifications of the Food Chemi- cals Codex, 3d Ed. (1981), p. 180, which is (c) In accordance with § 184.1(b)(1), incorporated by reference. Copies are the ingredient is used in food with no available from the National Academy limitation other than current good Press, 2101 Constitution Ave. NW., manufacturing practice. The affirma- Washington, DC 20418, or available for tion of this ingredient as generally rec- inspection 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) In accordance with § 184.1(b)(1), turing practice conditions of use: the ingredient is used in food with no (1) The ingredient is used as an limitation other than current good anticaking and free-flow agent as de- manufacturing practice. The affirma- fined in § 170.3(o)(1) of this chapter; a tion of this ingredient as generally rec- firming agent as defined in § 170.3(o)(10) ognized as safe (GRAS) as a direct of this chapter; a lubricant and release human food ingredient is based upon agent as defined in § 170.3(o)(18) of this the following current good manufac- chapter; a nutrient supplement as de- turing practice conditions of use: fined in § 170.3(o)(20) of this chapter; (1) The ingredient is used as a nutri- and a pH control agent as defined in ent supplement 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.
498
VerDate 06
(d) Prior sanctions for this ingredient sulfuric acid and evaporating the solu- different from the uses established in tion to crystallization. this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the Food Chemicals Codex, 3d Ed. (1981), p. 183, which is incor- [50 FR 13560, Apr. 5, 1985] porated by reference. Copies are avail- § 184.1440 Magnesium stearate. able from the National Academy Press, 2101 Constitution Ave. NW., Wash- (a) Magnesium stearate ington, DC 20418, or available for in- (Mg(C17H34COO)2, CAS Reg. No. 557–04–0) spection at the Office of the Federal is the magnesium salt of stearic acid. Register, 800 North Capitol Street, It is produced as a white precipitate by NW., suite 700, Washington, DC 20408. the addition of an aqueous solution of (c) In accordance with § 184.1(b)(1), magnesium chloride to an aqueous so- the ingredient is used in food with no lution of sodium stearate derived from limitation other than current good stearic acid that is obtained from edi- manufacturing practice. The affirma- ble sources and that conforms to the tion of this ingredient as generally rec- 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 § 170.3(o)(24) of this chapter. Register, 800 North Capitol Street, (2) The ingredient is used in foods at NW., suite 700, Washington, DC 20408. levels not to exceed current good man- (c) In accordance with § 184.1(b)(1), ufacturing practice. the ingredient is used in food with no (d) Prior sanctions for this ingredient limitation other than current good different from the uses established in manufacturing practice. The affirma- this section do not exist or have been tion of this ingredient as generally rec- waived. ognized as safe (GRAS) as a direct [50 FR 13560, Apr. 5, 1985] human food ingredient is based upon the following current good manufac- § 184.1443a Malt. turing practice conditions of use: (1) The ingredient is used as a lubri- (a) Malt is an enzyme preparation ob- cant and release agent as defined in tained from barley which has been soft- ened by a series of steeping operations § 170.3(o)(18) of this chapter; a nutrient and germinated under controlled condi- supplement as defined in § 170.3(o)(20) of tions. It is a brown, sweet, and viscous this chapter; and a processing aid as liquid or a white to tan powder. Its defined in § 170.3(o)(24) of this chapter. characterizing enzyme activities are α- (2) The ingredient is used in foods at amylase (EC 3.2.1.1.) and β-amylase (EC levels not to exceed current good man- 3.2.1.2). ufacturing practice. (b) The ingredient meets the general (d) Prior sanctions for this ingredient requirements and additional require- different from the uses established in ments for enzyme preparations in the this section do not exist or have been Food Chemicals Codex, 3d ed. (1981), p. waived. 110, which is incorporated by reference [50 FR 13560, Apr. 5, 1985] in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from § 184.1443 Magnesium sulfate. the National Academy Press, 2101 Con- (a) Magnesium sulfate (MgSO4·7H2O, stitution Ave., NW., Washington, DC CAS Reg. No. 10034–99–8) occurs natu- 20418, or may be examined at the Office rally as the mineral epsomite. It is pre- of Premarket Approval (HFS–200), Food pared by neutralization of magnesium and Drug Administration, 200 C St., oxide, hydroxide, or carbonate with SW., Washington, DC, and the Office of
499
VerDate 06
the Federal Register, 800 North Capitol ined at the Center for Food Safety and St., NW., suite 700, Washington, DC. Applied Nutrition’s Library, 200 C St. (c) In accordance with § 184.1(b)(1), SW., rm. 3321, Washington, DC, or at the ingredient is used in food with no the Office of the Federal Register, 800 limitation other than current good North Capitol St. NW., suite 700, Wash- manufacturing practice. The affirma- ington, DC. tion of this ingredient as GRAS as a di- (c) In accordance with § 184.1(b)(1), rect food ingredient is based upon the the ingredient is used in food with no following current good manufacturing limitation other than current good practice conditions of use: manufacturing practice. (1) The ingredient is used as an en- (d) Prior sanctions for this ingredient zyme as defined in § 170.3(o)(9) of this different from the uses established in chapter to hydrolyze starch or starch- derived polysaccharides. this section do not exist or have been (2) The ingredient is used in food at waived. levels not to exceed current good man- [48 FR 51911, Nov. 15, 1983; as amended at 60 ufacturing practice. FR 48893, Sept. 21, 1995; 63 FR 14611, Mar. 26, 1998] [60 FR 32911, June 26, 1995]
§ 184.1444 Maltodextrin. § 184.1445 Malt syrup (malt extract). (a) Malt is the product of barley (a) Maltodextrin ((C6H10O5)n, CAS 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 Press, 2101 Constitution Ave., NW., (b) FDA is developing food-grade Washington, DC 20418, or may be exam- specifications for malt syrup (malt ex- ined at the Office of the Federal Reg- tract) in cooperation with the National ister, 800 North Capital St. NW., suite Academy of Sciences. In the interim, 700, Washington, DC 20408, or at the Di- the ingredient must be of a purity suit- vision of Petition Control (HFS–217), able for its intended use. Center for Food Safety and Applied Nu- (c) In accordance with § 184.1(b)(1), trition, Food and Drug Administration, the ingredient is used in food with no 200 C St. SW., Washington, DC 20204. limitation other than current good (3) Maltodextrin derived from rice manufacturing practice. The affirma- starch meets the specifications of the tion of this ingredient as generally rec- Food Chemicals Codex, 4th ed. (1996), ognized as safe (GRAS) as a direct pp. 239 and 240, which is incorporated human food ingredient is based upon by reference in accordance with 5 the following current good manufac- U.S.C. 552(a) and 1 CFR part 51. Copies turing practice conditions of use: are available from the National Acad- (1) The ingredient is used as a fla- emy Press, 2101 Constitution Ave. NW., voring agent and adjuvant as defined in Washington, DC 20418, or may be exam- § 170.3(o)(12) of this chapter.
500
VerDate 06
(2) The ingredient is used in food at tained by precipitating manganese car- levels not to exceed current good man- bonate from manganese sulfate and so- ufacturing practice. dium carbonate solutions. The filtered (d) Prior sanctions for this ingredient and washed precipitate is digested first different from the uses established in with sufficient citric acid solution to this section do not exist or have been form manganous citrate and then with waived. sodium citrate to complete the reac- tion. [48 FR 51613, Nov. 10, 1983] (b) FDA is developing food-grade § 184.1446 Manganese chloride. specifications for manganese citrate in cooperation with the National Acad- (a) Manganese chloride (MnCl ·4H O, 2 2 emy of Sciences. In the interim, this CAS Reg. No. 7773–01–5) is a pink, ingredient must be of purity suitable translucent, crystalline product. It is for its intended use. also known as manganese dichloride. It is prepared by dissolving manganous (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no oxide, pyrolusite ore (MnO2), or re- duced manganese ore in hydrochloric limitation other than current good acid. The resulting solution is neutral- manufacturing practice. The affirma- ized to precipitate heavy metals, fil- tion of this ingredient as generally rec- tered, concentrated, and crystallized. ognized as safe (GRAS) as a direct (b) The ingredient meets the speci- human food ingredient is based upon fications of the Food Chemicals Codex, the following current good manufac- 3d Ed. (1981), p. 186, which is incor- turing practice conditions of use: porated by reference. Copies are avail- (1) The ingredient is used as a nutri- able from the National Academy Press, ent supplement as defined in 2101 Constitution Ave. NW., Wash- § 170.3(o)(20) 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 as defined in § 170.3(n)(1) of (c) In accordance with § 184.1(b)(1), this chapter; nonalcoholic beverages as the ingredient is used in food with no defined in § 170.3(n)(3) of this chapter; limitation other than current good dairy product analogs as defined in manufacturing practice. The affirma- § 170.3(n)(10) of this chapter; fish prod- tion of this ingredient as generally rec- ucts as defined in § 170.3(n)(13) of this ognized as safe (GRAS) as a direct chapter; meat products as defined in human food ingredient is based upon § 170.3(n)(29) of this chapter; milk prod- the following current good manufac- ucts as defined in § 170.3(n)(31) of this turing practice conditions of use: chapter; and poultry products as de- (1) The ingredient is used as a nutri- fined in § 170.3(n)(34) of this chapter. ent supplement as defined in The ingredient may be used in infant § 170.3(o)(20) of this chapter. formulas in accordance with section (2) The ingredient may be used in in- 412(g) of the Federal Food, Drug, and fant formulas in accordance with sec- Cosmetic Act (the act) or with regula- tion 412(g) of the Federal Food, Drug, tions promulgated under section and Cosmetic Act (the act) or with reg- 412(a)(2) of the act. ulations promulgated under section (d) Prior sanctions for this ingredient 412(a)(2) of the act. different from the uses established in (d) Prior sanctions for this ingredient this section do not exist or have been different from the uses established in waived. this section do not exist or have been [50 FR 19166, May 7, 1985] waived. [50 FR 19165, May 7, 1985] § 184.1452 Manganese gluconate. (a) Manganese gluconate § 184.1449 Manganese citrate. (C12H22MnO14·2H2O, CAS Reg. No. 648– (a) Manganese citrate (Mn3(C6H5O7)2, 0953–0998) is a slightly pink colored CAS Reg. No. 1002–46–65) is a pale or- powder. It is obtained by reacting man- ange or pinkish white powder. It is ob- ganese carbonate with gluconic acid in
501
VerDate 06
aqueous medium and then crystallizing sulfur dioxide on a slurry of manganese the product. dioxide in sulfuric acid, and the roast- (b) The ingredient meets the speci- ing of pyrolusite (MnO2) ore with solid fications of the Food Chemicals Codex, ferrous sulfate and coal, followed by 3d Ed. (1981), p. 186, which is incor- leaching and crystallization. porated by reference. Copies are avail- (b) The ingredient meets the speci- able from the National Academy Press, fications of the Food Chemicals Codex, 2101 Constitution Ave. NW., Wash- 3d Ed. (1981), p. 188, which is incor- ington, DC 20418, or available for in- porated by reference. Copies are avail- spection at the Office of the Federal able from the National Academy Press, Register, 800 North Capitol Street, 2101 Constitution Ave. NW., Wash- NW., suite 700, Washington, DC 20408. (c) In accordance with § 184.1(b)(1), ington, DC 20418, or available for in- the ingredient is used in food with no spection at the Office of the Federal limitation other than current good Register, 800 North Capitol Street, manufacturing practice. The affirma- NW., suite 700, Washington, DC 20408. tion of this ingredient as generally rec- (c) In accordance with § 184.1(b)(1), ognized as safe (GRAS) as a direct the ingredient is used in food with no human food ingredient is based upon limitation other than current good the following current good manufac- manufacturing practice. The affirma- turing practice conditions of use: tion of this ingredient as generally rec- (1) The ingredient is used as a nutri- ognized as safe (GRAS) as a direct ent supplement as defined in human food ingredient is based upon § 170.3(o)(20) of this chapter. the following current good manufac- (2) The ingredient is used in the fol- turing practice conditions of use: lowing foods at levels not to exceed (1) The ingredient is used as a nutri- current good manufacturing practice: ent supplement as defined in baked goods as defined in § 170.3(n)(1) of § 170.3(o)(20) of this chapter. this chapter; nonalcoholic beverages as (2) The ingredient is used in the fol- defined in § 170.3(n)(3) of this chapter; lowing foods at levels not to exceed dairy product analogs as defined in § 170.3(n)(10) of this chapter; fish prod- current good manufacturing practice: ucts as defined in § 170.3(n)(13) of this baked goods as defined in § 170.3(n)(1) of chapter; meat products as defined in this chapter; nonalcoholic beverages as § 170.3(n)(29) of this chapter; milk prod- defined in § 170.3(n)(3) of this chapter; ucts as defined in § 170.3(n)(31) of this dairy product analogs as defined in chapter; and poultry products as de- § 170.3(n)(10) of this chapter; fish prod- fined in § 170.3(n)(34) of this chapter. ucts as defined in § 170.3(n(13) of this The ingredient may be used in infant chapter; meat products as defined in formulas in accordance with section § 170.3(n)(29) of this chapter; milk prod- 412(g) of the Federal Food, Drug, and ucts as defined in § 170.3(n)(31) of this Cosmetic Act (the act) or with regula- chapter; and poultry products as de- tions promulgated under section fined in § 170.3(n)(34) of this chapter. 412(a)(2) of the act. The ingredient may be used in infant (d) Prior sanctions for this ingredient formulas in accordance with section different from the uses established in 412(g) of the Federal Food, Drug, and this section do not exist or have been Cosmetic Act (the act) or with regula- waived. tions promulgated under section [50 FR 19166, May 7, 1985] 412(a)(2) of the act. (d) Prior sanctions for this ingredient § 184.1461 Manganese sulfate. different from the uses established in (a) Manganese sulfate (MnSO4·H2O, this section do not exist or have been CAS Reg. No. 7785–0987–097) is a pale waived. pink, granular, odorless powder. It is obtained by reacting manganese com- [50 FR 19166, May 7, 1985] pounds with sulfuric acid. It is also ob- tained as a byproduct in the manufac- § 184.1472 Menhaden oil. ture of hydroquinone. Other manufac- (a) Menhaden oil. (1) Menhaden oil is turing processes include the action of prepared from fish of the genus
502
VerDate 06
Brevoortia, commonly known as menha- U.S.C. 552(a) and 1 CFR part 51. The den, by cooking and pressing. The re- availability of this incorporation by sulting crude oil is then refined using reference is given in paragraph the following steps: Storage (winteriza- (a)(2)(iii) of this section. tion), degumming (optional), neutral- (vii) Peroxide value. Not more than 5 ization, bleaching, and deodorization. milliequivalents per kilogram of oil as Winterization may separate the oil and determined by the American Oil Chem- produce a solid fraction. ists’ Society Official Method Cd 8–53— (2) Menhaden oil meets the following ‘‘Peroxide Value, Acetic Acid—Chloro- specifications: form Method’’ (updated 1992) or Rec- (i) Color and state. Yellow liquid to ommended Practice Cd 8b–90—‘‘Per- white solid. oxide Value, Acetic Acid—Isooctane (ii) Odor. Odorless to slightly fishy. Method’’ (updated 1992), which are in- (iii) Saponification value. Between 180 corporated by reference in accordance and 200 as determined by the American with 5 U.S.C. 552(a) and 1 CFR part 51. Oil Chemists’ Society Official Method The availability of this incorporation 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. (vi) Free fatty acids. Not more than 0.1 Cookies, crackers, § 170.3(n)(1) of 5.0 percent 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
503
VerDate 06
(3) Partially hydrogenated and hy- Category of food Maximum level of use in food (as served) drogenated menhaden oils are used as Fats, oils, § 170.3(n)(12) of this chap- 20.0 percent edible fats or oils, as defined in ter, but not in infant formula.. § 170.3(n)(12) of this chapter, in food at Yogurt, § 170.3(n)(31) of this chapter. 4.0 percent levels not to exceed current good man- Cheese products, § 170.3(n)(5) of 5.0 percent this chapter.. ufacturing practice. Frozen dairy products, § 170.3(n)(20) 5.0 percent (4) If the fat or oil is fully hydro- of this chapter.. genated, the name to be used on the Meat products, § 170.3(n)(29) of this 10.0 percent label of a product containing it shall chapter.. Egg products, § 170.3(n)(11) of this 5.0 percent include the term ‘‘hydrogenated,’’ or if chapter.. it is partially hydrogenated, the name Fish products, § 170.3(n)(13) of this 20.0 percent shall include the term ‘‘partially hy- chapter.. Condiments, § 170.3(n)(8) of this 5.0 percent drogenated,’’ in accordance with chapter.. § 101.4(b)(14) of this chapter. Soup mixes, § 170.3(n)(40) of this 3.0 percent chapter.. [62 FR 30756, June 5, 1997] Snack foods, § 170.3(n)(37) of this 5.0 percent chapter.. § 184.1490 Methylparaben. Nut products, § 170.3(n)(32) of this 5.0 percent chapter.. (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- drogenated menhaden oils meet the fol- (c) The ingredient is used as an anti- lowing specifications: microbial agent as defined in (i) Color. Opaque white solid. § 170.3(o)(2) of this chapter. (ii) Odor. Odorless. (d) The ingredient is used in food at (iii) Saponification value. Between 180 levels not to exceed good manufac- and 200. turing practices. Current good manu- facturing practice results in a max- (iv) Iodine number. Not more than 119 for partially hydrogenated menhaden imum level of 0.1 percent in food. oil and not more than 10 for fully hy- (e) Prior sanctions for this ingredient drogenated menhaden oil. different from the uses established in (v) Unsaponifiable matter. Not more this regulation do not exist or have than 1.5 percent.– been waived. (vi) Free fatty acids. Not more than 0.1 [42 FR 14653, Mar. 15, 1977, as amended at 49 percent. FR 5612, Feb. 14, 1984] (vii) Peroxide value. Not more than 5 milliequivalents per kilogram of oil. § 184.1498 Microparticulated protein (viii) Nickel. Not more than 0.5 part product. per million. (a) Microparticulated protein product (ix) Mercury. Not more than 0.5 part is prepared from egg whites or milk per million. protein or a combination of egg whites (x) Arsenic (as As). Not more than 0.1 and milk protein. These protein part per million. sources may be used alone or in com- (xi) Lead. Not more than 0.1 part per bination with other safe and suitable million. ingredients to form the
504
VerDate 06
microparticulated product. The mix- ucts are further purified to obtain a ture of ingredients is high-shear heat mixture of glycerides, free fatty acids, processed to achieve a smooth and and free glycerin that contains at least creamy texture similar to that of fat. 90 percent-by-weight glycerides. Safe and suitable ingredients used in (b) The ingredient meets the speci- the preparation of the fications of the Food Chemicals Codex, microparticulated protein product 3d Ed. (1981), p. 201, which is incor- must be used in compliance with the porated by reference in accordance limitations of the appropriate regula- with 5 U.S.C. 552(a). Copies are avail- tions in parts 172, 182, and 184 of this able from the National Academy Press, chapter. 2101 Constitution Ave. NW., Wash- (b) The ingredient is used in food in ington, DC 20418, or available for in- accordance with § 184.1(b)(2) at levels spection at the Office of the Federal not to exceed current good manufac- Register, 800 North Capitol Street, turing practice. The affirmation of the NW., suite 700, Washington, DC 20005. use of this ingredient as generally rec- (c) In accordance with § 184.1(b)(1), ognized as safe (GRAS) as a direct the ingredient is used in food with no human food ingredient is based upon limitation other than current good the following conditions of use: manufacturing practice. The affirma- (1) The ingredient is used in food as a tion of this ingredient as generally rec- thickener as defined in § 170.3(o)(28) of ognized as safe (GRAS) as a direct this chapter or as a texturizer as de- human food ingredient is based upon fined in § 170.3(o)(32) of this chapter. the following current good manufac- (2) The ingredient is used in frozen turing practice conditions of use: dessert-type products except that the (1) The ingredient is used in food as a ingredient may not be used to replace dough strengthener as defined in the milk fat required in standardized § 170.3(o)(6) of this chapter; an emulsi- frozen desserts. fier and emulsifier salt as defined in (3) The name of the ingredient used § 170.3(o)(8) of this chapter; a flavoring in the ingredient statement on both agent and adjuvant as defined in bulk and packaged food must include § 170.3(o)(12) of this chapter; a formula- the source of the protein (e.g., tion aid as defined in § 170.3(o)(14) of ‘‘microparticulated egg white pro- this chapter; a lubricant and release tein’’), followed by a parenthetical list- agent as defined in § 170.3(o)(18) of this ing of each of the ingredients in the chapter; a solvent and vehicle as de- microparticulated protein product, in fined in § 170.3(o)(27) of this chapter; a descending order of predominance. stabilizer and thickener as defined in Microparticulated protein product § 170.3(o)(28) of this chapter; a surface- 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
505
VerDate 06
that are derived from edible sources the Center for Food Safety and Applied with phosphorus pentoxide Nutrition’s Library, Food and Drug Ad- (tetraphosphorus decoxide) followed by ministration, 200 C St. SW., rm. 3321, neutralization with sodium carbonate. Washington, DC, or at the Office of the (b) FDA is developing food-grade Federal Register, 800 North Capitol St. specifications for monosodium phos- NW., suite 700, Washington, DC. phate mono- and diglycerides in co- (c) In accordance with § 184.1(b)(1), operation with the National Academy the ingredient is used in food with no of Sciences. In the interim, this ingre- limitation other than current good dient must be of a purity suitable for manufacturing practice. The affirma- its intended use. tion of this ingredient as generally rec- (c) In accordance with § 184.1(b)(1), ognized as safe (GRAS) as direct the ingredient is used in food with no human food ingredient is based upon limitation other than current good the following current good manufac- manufacturing practice. The affirma- turing practice conditions of use: tion of this ingredient as generally rec- (1) The ingredient is used as a nutri- ognized as safe (GRAS) as a direct ent supplement as defined in human food ingredient is based upon § 170.3(o)(20) of this chapter. the following current good manufac- (2) The ingredient is used in foods at turing practice conditions of use: levels not to exceed current good man- (1) The ingredient is used in food as ufacturing practice. The ingredient an emulsifier and emulsifier salt as de- may also be used in infant formula in fined in § 170.3(o)(8) of this chapter, a accordance with section 412(g) of the lubricant and release agent as defined Federal Food, Drug, and Cosmetic Act in § 170.3(o)(18) of this chapter, and as a (the Act) or with regulations promul- surface-active agent as defined in gated under section 412(a)(2) of the Act. § 170.3(o)(29) of this chapter. (d) Prior sanctions for this ingredient (2) The ingredient is used in the fol- different from the uses established in lowing foods at levels not to exceed this section do not exist or have been current good manufacturing practice: waived. dairy product analogs as defined in § 170.3(n)(10) of this chapter and soft [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. 2, 1983, as amended at 64 FR 1760, Jan. 12, candy as defined in § 170.3(n)(38) of this 1999] chapter. (d) Prior sanctions for this ingredient § 184.1535 Niacinamide. different from the uses established in (a) Niacinamide (C H N O, CAS Reg. this section do not exist or have been 6 6 2 No. 98–92–0) is the chemical 3- waived. pyridinecarboxylic acid amide (nicotin- [54 FR 7404, Feb. 21, 1989] amide). It is a white crystalline powder that is soluble in water, alcohol, ether, § 184.1530 Niacin. and glycerol. It melts between 128° and (a) Niacin (C6H5NO2, CAS Reg. No. 59– 131 °C. 67–6) is the chemical 3- (b) The ingredient meets the speci- pyridinecarboxylic acid (nicotinic fications of the Food Chemicals Codex, acid). It is a non-hygroscopic, stable, 3d Ed. (1981), p. 205, which is incor- white, crystalline solid that sublimes 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
506
VerDate 06
the following current good manufac- this section do not exist or have been turing practice conditions of use: waived. (1) The ingredient is used as a nutri- [48 FR 51618, Nov. 10, 1983] ent supplement as defined in § 170.3(o)(20) of this chapter. § 184.1538 Nisin preparation. (2) The ingredient is used in foods at (a) Nisin preparation is derived from levels not to exceed current good man- pure culture fermentations of certain ufacturing practice. The ingredient strains of Streptococcus lactis may also be used in infant formula in Lancefield Group N. Nisin preparation accordance with section 412(g) of the contains nisin (CAS Reg. No. 1414–45–5), Federal Food, Drug, and Cosmetic Act a group of related peptides with anti- (the act) or with regulations promul- biotic activity. gated under section 412(a)(2) of the Act. (b) The ingredient is a concentrate or (d) Prior sanctions for this ingredient dry material that meets the specifica- different from the uses established in tions that follow when it is tested as this section do not exist or have been described in ‘‘Specifications for Iden- tity and Purity of Some Antibiotics,’’ waived. World Health Organization, FAO Nutri- [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. tion Meeting Report Series, No. 45A, 2, 1983] 1969, which is incorporated by ref- erence. Copies are available from the § 184.1537 Nickel. Dockets Management Branch (HFA– (a) Elemental nickel (CAS Reg. No. 305), Food and Drug Administration, 7440–02–0) is obtained from nickel ore rm. 1–23, 12420 Parklawn Dr., Rockville, by transforming it to nickel sulfide MD 20857, or available for inspection at (Ni S ). The sulfide is roasted in air to the Office of the Federal Register, 800 3 2 North Capitol Street, NW., suite 700, 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. (c) The ingredient is used as an anti- (1) The ingredient is used as a cata- microbial agent as defined in lyst as defined in § 170.3(o)(24) of this § 170.3(o)(2) of this chapter to inhibit chapter. the outgrowth of Clostridium botulinum (2) The ingredient is used in the hy- spores and toxin formation in pasteur- drogenation of fats and oils as defined ized cheese spreads and pasteurized in § 170.3(n)(12) of this chapter at levels process cheese spreads listed in not to exceed current good manufac- § 133.175; pasteurized cheese spread with turing practice. Current good manufac- fruits, vegetables, or meats as defined turing practice includes the removal of in § 133.176; pasteurized process cheese nickel from fats and oils following hy- spread as defined in § 133.179; pasteur- drogenation. ized process cheese spread with fruits, (d) Prior sanctions for this ingredient vegetables, or meats as defined in different from the uses established in § 133.180 of this chapter.
507
VerDate 06
(d) The ingredient is used at levels § 184.1545 Nitrous oxide. not to exceed good manufacturing (a) Nitrous oxide (empirical formula practice in accordance with § 184.1(b)(1) N O, CAS Reg. No. 10024–97–2) is also of this chapter. The current good man- 2 known as dinitrogen monoxide or ufacturing practice level is the quan- laughing gas. It is a colorless gas, tity of the ingredient that delivers a about 50 percent heavier than air, with maximum of 250 parts per million of a slightly sweet smell. It does not burn nisin in the finished product as deter- but will support combustion. Nitrous mined by the British Standards Insti- oxide is manufactured by the thermal tution Methods, ‘‘Methods for the Esti- decomposition of ammonium nitrate. mation and Differentiation of Nisin in Higher oxides of nitrogen are removed Processed Cheese,’’ BS 4020 (1974), by passing the dry gas through a series which is incorporated by reference. of scrubbing towers. Copies are available from the Dockets (b) The Food and Drug Administra- Management Branch (HFA–305), Food tion is developing food-grade specifica- and Drug Administration, rm. 1–23, tions for nitrous oxide in cooperation 12420 Parklawn Dr., Rockville, MD with the National Academy of 20857, or available for inspection at the Sciences. In the interim, the ingredient Office of the Federal Register, 800 must be of a purity suitable for its in- North Capitol Street, NW., suite 700, tended use. Washington, DC 20408. (c) In accordance with § 184.1(b)(1), [53 FR 11250, Apr. 6, 1988, as amended at 59 the ingredient is used in food with no FR 14364, Mar. 28, 1994] limitations other than current good manufacturing practice. The affirma- § 184.1540 Nitrogen. tion of this ingredient as generally rec- (a) Nitrogen (empirical formula N2, ognized as safe (GRAS) as a direct CAS Reg. No. 7727–37–9) is a colorless, human food ingredient is based upon odorless, flavorless gas that is pro- the following current good manufac- duced commercially by the fraction- turing practice conditions of use: ation of liquid air. (1) The ingredient is used as a propel- (b) The Food and Drug Administra- lant, aerating agent, and gas as defined tion is developing food-grade specifica- in § 170.3(o)(25) of this chapter. tions for nitrogen in cooperation with (2) The ingredient is used in dairy the National Academy of Sciences. In product analogs as defined in the interim, the ingredient must be of § 170.3(n)(10) of this chapter at levels a purity suitable for its intended use. not to exceed current good manufac- (c) In accordance with § 184.1(b)(1), turing practice. the ingredient is used in food with no (d) Prior sanctions for this ingredient limitations 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 [48 FR 57270, Dec. 29, 1983] human food ingredient is based upon the following current good manufac- § 184.1553 Peptones. turing practice conditions of use: (1) The ingredient is used as a propel- (a) Peptones are a variable mixture lant, aerating agent, and gas as defined of polypeptides, oligopeptides, and in § 170.3(o)(25) of this chapter. amino acids that are produced by par- tial hydrolysis of casein, animal tissue, (2) The ingredient is used in food at soy protein isolate, gelatin, defatted levels not to exceed current good man- fatty tissue, egg albumin, or lactal- ufacturing practice. bumin (whey protein). Peptones are (d) Prior sanctions for this ingredient produced from these proteins using different from the uses established in proteolytic enzymes that either are this section do not exist or have been considered to be generally recognized waived. as safe (GRAS) or are regulated as food [48 FR 57270, Dec. 29, 1983] additives. Peptones are also produced
508
VerDate 06
by denaturing any of the proteins list- (3) The ingredient is used as a sta- ed in this paragraph with safe and suit- bilizer and thickener as defined in able acids or heat. § 170.3(o)(28) of this chapter in peanut (b) FDA is developing food-grade butter. The use level of the ingredient specifications for peptones in coopera- is limited by good manufacturing prac- tion with the National Academy of tice (GMP) to the minimum amount re- Sciences. In the interim, these ingredi- quired to produce the intended effect. ents must be of a purity suitable for Current good manufacturing practices their intended use. result in a maximum level of 2 percent (c) In accordance with § 184.1(b)(1), in peanut butter. these ingredients are used in food with (b) Superglycerinated fully hydro- no limitation other than current good genated rapeseed oil. (1) manufacturing practice. The affirma- Superglycerinated fully hydrogenated tion of these ingredients as GRAS as rapeseed oil is a mixture of mono- and direct human food ingredients is based diglycerides with triglycerides as a upon the following current good manu- minor component. The fatty acid com- facturing practice conditions of use: position is a mixture of saturated fatty (1) These ingredients are used as nu- acids present in the same proportions trient supplements as defined in as those resulting from the full hydro- § 170.3(o)(20) of this chapter; as proc- genation of fatty acids in natural essing aids as defined in § 170.3(o)(24) of rapeseed oil. It is made by adding ex- 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
509
VerDate 06
with a low erucic acid content. Chemi- practice. Current good manufacturing cally, low erucic acid rapeseed oil is a practice results in a maximum level, as mixture of triglycerides, composed of served, of 0.002 percent for cheese as de- both saturated and unsaturated fatty fined in § 170.3(n)(5) of this chapter. acids, with an erucic acid content of no (e) Prior sanctions for this ingredient more than 2 percent of the component different from the uses established in fatty acids. this section do not exist or have been (2) Low erucic acid rapeseed oil as de- waived. fined in paragraph (c)(1) of this section may be partially hydrogenated to re- [43 FR 36064, Aug. 15, 1978. Redesignated and duce the proportion of unsaturated amended at 50 FR 49537, Dec. 3, 1985] fatty acids. When the partially hydro- § 184.1563 Ozone. genated low erucic acid rapeseed oil is used, it shall be referred to as partially (a) Ozone (O3, CAS Reg. No. 10028–15– hydrogenated low erucic acid rapeseed 6) is an unstable blue gas with a pun- oil. gent, characteristic odor, which occurs (3) In addition to limiting the con- freely in nature, It is produced com- tent of erucic acid to a level not ex- mercially by passing electrical dis- ceeding 2 percent of the component charges or ionizing radiation through fatty acids, FDA is developing other air or oxygen. food-grade specifications for low erucic (b) The ingredient must be of a pu- acid rapeseed oil and partially hydro- rity suitable for its intended use in ac- genated low erucic acid rapeseed oil in cordance with § 170.30(h)(1) of this chap- cooperation with the National Acad- ter. emy of Sciences. In the interim, the in- (c) In accordance with § 184.1(b)(2), gredients must be of a purity suitable the ingredient is used to treat food for their intended use. only within the following specific limi- (4) Low erucic acid rapeseed oil and tations: partially hydrogenated low erucic acid Maximum treat- rapeseed oil are used as edible fats and Category of food ment level in food Functional use oils in food, except in infant formula, at levels not to exceed current good Bottled water that Not to exceed cur- Antimicrobial 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- § 184.1560 Ox bile extract. (b)(2) through ual level at the (b)(5) of this time of bottling (a) Ox bile extract (CAS Reg. No. chapter. of 0.4 milligram 8008–63–7), also known as purified of ozone per oxgall or sodium choleate, is a yel- liter of bottled lowish green, soft solid, with a partly water. sweet, partly bitter, disagreeable taste. It is the purified portion of the bile of [47 FR 50210, Nov. 5, 1982, as amended at 60 an ox obtained by evaporating the alco- FR 57130, Nov. 13, 1995] 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- ments in the Food Chemicals Codex, 3d 1 Copies may be obtained from: U.S. ed. (1981), p. 110, which is incorporated Pharmacopeial Convention, Inc., 12601 by reference in accordance with 5 Twinbrook Parkway, Rockville, MD 20852. U.S.C. 552(a) and 1 CFR part 51. Copies
510
VerDate 06
are available from the National Acad- chapter; processing aid as defined in emy Press, 2101 Constitution Ave. NW., § 170.3(o)(24) of this chapter; and Washington, DC 20418, or may be exam- texturizer as defined in § 170.3(o)(32) of ined at the Office of Premarket Ap- this chapter. proval (HFS–200), Food and Drug Ad- (2) The ingredient is used in food at ministration, 200 C St. SW., Wash- levels not to exceed current good man- ington, DC, and the Office of the Fed- ufacturing practice. eral Register, 800 North Capitol St. (d) Prior sanctions for this ingredient NW., suite 700, Washington, DC. 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 [48 FR 48806, Oct. 21, 1983] manufacturing practice. The affirma- tion of this ingredient as GRAS as a di- § 184.1588 Pectins. rect food ingredient is based upon the (a) The pectins (CAS Reg. No. 9000– following current good manufacturing 69–5) are a group of complex, high mo- practice conditions of use: lecular weight polysaccharides found (1) The ingredient is used as an en- in plants and composed chiefly of par- zyme as defined in § 170.3(o)(9) of this tially methylated polygalacturonic chapter to hydrolyze proteins or acid units. Portions of the carboxly polypeptides. group occur as methyl esters, and the (2) The ingredient is used in food at remaining carboxyl groups exist in the levels not to exceed current good man- form of the free acid or as its ammo- ufacturing practice. nium, potassium, or sodium (CAS Reg. [60 FR 32911, June 26, 1995] No. 9000–59–8) salts, and in some types as the acid amide. Thus, the pectins § 184.1585 Papain. 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:
511
VerDate 06
(1) The ingredients are used as emul- ginic acid, a natural polyuronide con- sifiers as defined in § 170.3(o)(8) of this stituent of certain brown algae. Potas- chapter and as stabilizers and thick- sium alginate is prepared by the neu- eners as defined in § 170.3(o)(28) of this tralization of purified alginic acid with chapter. appropriate pH control agents. (2) The ingredients are used in food (b) The ingredient meets the speci- at levels not to exceed current good fications of the Food Chemicals Codex, manufacturing practice. 3d Ed. (1981), p. 239, which is incor- (d) Prior sanctions for these ingredi- porated by reference. Copies are avail- ents different from the uses established able from the National Academy Press, in this section do not exist or have 2101 Constitution Ave. NW., Wash- been waived. ington, DC 20418, or available for in- [48 FR 51149, Nov. 7, 1983] spection at the Office of the Federal Register, 800 North Capitol Street, § 184.1595 Pepsin. NW., suite 700, Washington, DC 20408. (a) Pepsin (CAS Reg. No. 9001–75–6) is (c) In accordance with § 184.1(b)(2), an enzyme preparation obtained from the ingredient is used in food only the glandular layer of hog stomach. It within the following specific limita- is a white to light tan powder, amber tions: paste, or clear amber to brown liquid. Maximum Its characterizing enzyme activity is level of use in that of a peptide hydrolase (EC Category of food food (as Functional use 3.4.23.1). served) (b) The ingredient meets the general (percent) requirements and additional require- Confections and 0.1 Stabilizer, thickener, ments for enzyme preparations in the frostings, § 170.3(o)(28) of this Food Chemicals Codex, 3d ed. (1981), p. § 170.3(n)(9) of this chapter chapter.. 110, which is incorporated by reference Gelatins and puddings, 0.7 Do. in accordance with 5 U.S.C. 552(a) and 1 § 170.3(n)(22) of this CFR part 51. Copies are available from chapter. the National Academy Press, 2101 Con- Processed fruits and 0.25 Do. fruit juices, stitution Ave. NW., Washington, DC § 170.3(n)(35) of this 20418, or may be examined at the Office chapter. of Premarket Approval (HFS–200), Food 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 [47 FR 29951, July 9, 1982] manufacturing practice. The affirma- tion of this ingredient as GRAS as a di- § 184.1613 Potassium bicarbonate. rect food ingredient is based upon the (a) Potassium bicarbonate (KHCO3, following current good manufacturing CAS Reg. No. 298–14–6) is made by the practice conditions of use: following processes: (1) The ingredient is used as an en- (1) By treating a solution of potas- zyme as defined in § 170.3(o)(9) of this sium hydroxide with carbon dioxide; chapter to hydrolyze proteins or (2) By treating a solution of potas- polypeptides. sium carbonate with carbon dioxide. (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. 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
512
VerDate 06
Register, 800 North Capitol Street, human food ingredient is based upon NW., suite 700, Washington, DC 20408. the following current good manufac- (c) In accordance with § 184.1(b)(1), turing practice conditions of use: the ingredient is used in food with no (1) The ingredient is used in food as a limitation other than current good flavoring agent and adjuvant as defined manufacturing practice. The affirma- in § 170.3(o)(12) of this chapter; nutrient tion of this ingredient as generally rec- supplement as defined in § 170.3(o)(20) of ognized as safe (GRAS) as a direct this chapter; pH control agent as de- human food ingredient is based upon fined in § 170.3(o)(23) of this chapter; the following current good manufac- and processing aid as defined in turing practice conditions of use: § 170.3(o)(24) of this chapter. (1) The ingredient is used as a formu- (2) The ingredient is used in food at lation aid as defined in § 170.3(o)(14) of this chapter; nutrient supplemlent as levels not to exceed current good man- defined in § 170.3(o)(20) of this chapter; ufacturing practice. pH control agent as defined in (d) Prior sanctions for this ingredient § 170.3(o)(23) of this chapter; and proc- different from the uses established in essing aid as defined in § 170.3(o)(24) of this section do not exist or have been this chapter. waived. (2) The ingredient is used in food at [48 FR 52442, Nov. 18, 1983] levels not to exceed current good man- ufacturing practice. § 184.1622 Potassium chloride. (d) Prior sanctions for this ingredient different from the uses established in (a) Potassium chloride (KCl, CAS this section do not exist or have been Reg. No. 7447–40–7) is a white, odorless waived. solid prepared from source minerals by fractional crystallization or flotation. [48 FR 52442, Nov. 18, 1983] It is soluble in water and glycerol and has a saline taste at low concentration § 184.1619 Potassium carbonate. levels. (a) Potassium carbonate (K2CO3, CAS (b) The ingredient meets the speci- Reg. No. 584–08–7) is produced by the fications of the Food Chemicals Codex, following methods of manufacture: 3d Ed. (1981), p. 241, which is incor- (1) By electrolysis of potassium chlo- porated by reference. Copies are avail- ride followed by exposing the resultant able from the National Academy Press, potassium to carbon dioxide; 2101 Constitution Ave. NW., Wash- (2) By treating a solution of potas- ington, DC 20418, or available for in- sium hydroxide with excess carbon di- spection at the Office of the Federal oxide to produce potassium carbonate; (3) By treating a solution of potas- Register, 800 North Capitol Street, sium hydroxide with carbon dioxide to NW., suite 700, Washington, DC 20408. produce potassium bicarbonate, which (c) In accordance with § 184.1(b)(1), is then heated to yield potassium car- the ingredient is used in food with no bonate. 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. 240, 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, D.C. 20418, or available for in- (1) The ingredient is used as a flavor spection at the Office of the Federal enhancer as defined in § 170.3(o)(11) of Register, 800 North Capitol Street, this chapter; as a flavoring agent as de- NW., suite 700, Washington, DC 20408. fined in § 170.3(o)(12) of this chapter; as (c) In accordance with § 184.1(b)(1), a nutrient supplement as defined in the ingredient is used in food with no § 170.3(o)(20) of this chapter; as a pH limitation other than current good control agent as defined in §170.3(o)(23) manufacturing practice. the affirma- of this chapter; and as a stabilizer or 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.
513
VerDate 06
(2) The ingredient is used in food at lumps, and powders. Potassium hydrox- levels not to exceed current good man- ide is obtained commercially from the ufacturing practice. Potassium chlo- electrolysis of potassium chloride solu- ride may be used in infant formula in tion in the presence of a porous dia- accordance with section 412(g) of the phragm. Federal Food, Drug, and Cosmetic Act (b) The ingredient meets the speci- (the Act) or with regulations promul- fications of the Food Chemicals Codex, gated under section 412(a)(2) of the Act. 3d Ed. (1981), which is incorporated by (d) Prior sanctions for this ingredient reference. Copies are available from different from the uses established in the National Academy Press, 2101 Con- this section do not exist or have been stitution Ave. NW., Washington, DC waived. 20418, or available from inspection at the Office of the Federal Register, 800 [48 FR 51614, Nov. 10, 1983] North Capitol Street, NW., suite 700, § 184.1625 Potassium citrate. Washington, DC 20408. (c) In accordance with § 184.1(b)(1), (a) Potassium citrate (C6H5K3O7·H2O, the ingredient is used in food with no CAS Reg. No. 006100–0905–096) is the po- limitation other than current good tassium salt of citric acid. It is pre- manufacturing practice. The affirma- pared by neutralizing citric acid with tion of this ingredient as generally rec- potassium hydroxide or potassium car- ognized as safe (GRAS) as a direct bonate. It occurs as transparent crys- human food ingredient is based upon tals or a white granular powder, is the following current good manufac- odorless and deliquescent, and contains turing practice conditions of use: one mole of water per mole of potas- (1) The ingredient is used as a formu- sium citrate. lation aid as defined in § 170.3(o)(14) of (b) The ingredient meets the speci- this chapter; a pH control agent as de- fications of the Food Chemicals Codex, fined in § 170.3(o)(23) of the chapter; a 3d ed. (1981), p. 242, which is incor- processing aid as defined in § 170.3(o)(24) porated by reference in accordance of this chapter; and a stabilizer and with 5 U.S.C. 552(a) and 1 CFR part 51. thickener as defined in § 170.3(o)(28) of Copies are available from the National this chapter. Academy Press, 2101 Constitution Ave. (2) The ingredient is used in food at NW., Washington, DC 20418, and the levels not to exceed current good man- Center for Food Safety and Applied Nu- ufacturing practice. trition (HFS–200), 200 C St. SW., Wash- (d) Prior sanctions for this ingredient ington, DC 20204, or may be examined different from the uses established in at the Office of the Federal Register, this section do not exist or have been 800 North Capitol St. NW., suite 700, waived. Washington, DC. [48 FR 52444, Nov. 18, 1983] (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no § 184.1634 Potassium iodide. limitation other than current good (a) Potassium iodide (KI, CAS Reg. manufacturing practice. No. 7681–11–0) is the potassium salt of (d) Prior sanctions for this ingredient hydriodic acid. It occurs naturally in different from the uses established in sea water and in salt deposits, but can this section, or different from those set be prepared by reacting hydriodic acid forth in part 181 of this chapter, do not (HI) with potassium bicarbonate exist or have been waived. (KHCO3). [59 FR 63896, Dec. 12, 1994] (b) The ingredient meets the speci- fications of the ‘‘Food Chemicals § 184.1631 Potassium hydroxide. Codex,’’ 3d Ed. (1981), pp. 246–247, which (a) Potassium hydroxide (KOH, CAS is incorporated by reference. Copies Reg. No. 1310–58–3) is also known as may be obtained from the National caustic potash, potash lye, and potassa. Academy Press, 2101 Constitution Ave. The empirical formula is KOH. It is a NW., Washington, DC 20418, or may be white, highly deliquescent caustic examined at the Office of the Federal solid, which is marketed in several Register, 800 North Capitol Street, forms, including pellets, flakes, sticks, NW., suite 700, Washington, DC 20408.
514
VerDate 06
(c) The ingredient is used as a nutri- ingredient must be of a purity suitable ent supplement as defined in for its intended use. § 170.3(o)(20) of this chapter. (c) In accordance with § 184.1(b)(1), (d) The ingredient is used in table the ingredient is used in food with no salt in accordance with § 184.1(b)(2) of limitation other than current good this chapter as a source of dietary io- manufacturing practice. This regula- dine at a maximum level of 0.01 per- tion does not authorize its use in in- cent. fant foods and infant formulas. The af- (e) Prior sanctions for this ingredient firmation of this ingredient as gen- different from the uses established in erally recognized as safe (GRAS) as a this section do not exist or have been direct human food ingredient is based waived. upon the following current good manu- 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- § 184.1635 Potassium iodate. vant as defined in § 170.3(o)(12) of this 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 (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. 252, which is in- waived. corporated by reference. Copies may be obtained from the National Academy [43 FR 11699, Mar. 21, 1978, as amended at 49 Press, 2101 Constitution Ave. NW., FR 5613, Feb. 14, 1984] Washington, DC 20418, or may be exam- ined at the Office of the Federal Reg- § 184.1639 Potassium lactate. ister, 800 North Capitol Street, NW., (a) Potassium lactate (C3H5O3K, CAS suite 700, Washington, DC 20408. Reg. No. 996–31–6) is the potassium salt (c) The ingredient is used as a fla- of lactic acid. It is a hydroscopic, voring agent and adjuvant as defined in white, odorless solid and is prepared § 170.3(o)(12) of this chapter. commercially by the neutralization of (d) The ingredient is used in food at lactic acid with potassium hydroxide. levels not to exceed good manufac- (b) FDA is developing food-grade turing practice in accordance with specifications for potassium lactate in § 184.1(b)(1). Current good manufac- cooperation with the National Acad- turing practice results in a maximum emy of Sciences. In the interim, this level, as served, of 0.015 percent for
515
VerDate 06
nonalcoholic beverages as defined in (b) The ingredient meets the speci- § 170.3(n)(3) of this chapter. fications of the ‘‘Food Chemicals (e) Prior sanctions for this ingredient Codex,’’ 3d Ed. (1981), pp. 257–258, which different from the uses established in is incorporated by reference. Copies this section do not exist or have been may be obtained from the National waived. Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be [45 FR 6086, Jan. 25, 1980, as amended at 49 examined at the Office of the Federal FR 5613, Feb. 14, 1984] Register, 800 North Capitol Street, § 184.1655 Propane. NW., suite 700, Washington, DC 20408. (c) The ingredient is used as an anti- (a) Propane (empirical formula C3H8, oxidant as defined in § 170.3(o)(3) of this CAS Reg. No. 74–98–6) is also known as chapter. dimethylmethane or propyl hydrid. It (d) The ingredient is used in food at is a colorless, odorless, flammable gas levels not to exceed good manufac- at normal temperatures and pressures. turing practice in accordance with It is easily liquefied under pressure at § 184.1(b)(1). Good manufacturing prac- room temperature and is stored and tice results in a maximum total con- shipped in the liquid state. Propane is tent of antioxidants of 0.02 percent of obtained from natural gas by fraction- the fat or oil content, including the es- ation following absorption in oil, ad- sential (volatile) oil content, of the sorption to surface-active agents, or re- food. frigeration. (e) Prior sanctions for this ingredient (b) The Food and Drug Administra- different from the uses established in tion is developing food-grade specifica- this section, or different from that tions for propane in cooperation with stated in part 181 of this chapter, do the National Academy of Sciences. In not exist or have been waived. the interim, the ingredient must be of 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 § 184.1666 Propylene glycol. manufacturing practice. The affirma- 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
516
VerDate 06
as defined in § 170.3(o)(8) of this chap- (d) The ingredient is used in food at ter; flavor agent as defined in levels not to exceed good manufac- § 170.3(o)(12) of this chapter; formula- turing practices. Current good manu- tion aid as defined in § 170.3(o)(14) of facturing practice results in a max- this chapter; humectant as defined in imum level of 0.1 percent in food. § 170.3(o)(16) of this chapter; processing (e) Prior sanctions for this ingredient aid as defined in § 170.3(o)(24) of this different from the uses established in chapter; solvent and vehicle as defined this regulation do not exist or have in § 170.3(o)(27) of this chapter; sta- been waived. bilizer and thickener as defined in [42 FR 14653, Mar. 15, 1977, as amended at 49 § 170.3(o)(28) of this chapter; surface-ac- FR 5613, Feb. 14, 1984] tive agent as defined in § 170.3(o)(29) of this chapter; and texturizer as defined § 184.1676 Pyridoxine hydrochloride. in § 170.3(o)(32) of this chapter. (a) Pyridoxine hydrochloride (d) The ingredient is used in foods at (C8H11NO3·HCl, CAS Reg. No. 58–56–0) is levels not to exceed current good man- the chemical 3-hydroxy–4,5- ufacturing practice in accordance with dihydroxymethy–2-methylpyridine hy- § 184.1(b)(1). Current good manufac- drochloride that is prepared by chem- turing practice results in maximum ical synthesis. levels, as served, of 5 percent for alco- (b) The ingredient meets the speci- holic beverages, as defined in fications of the Food Chemicals Codex, § 170.3(n)(2) of this chapter; 24 percent 3d Ed. (1981), p. 260, which is incor- for confections and frostings as defined porated by reference. Copies are avail- in § 170.3(n)(9) of this chapter; 2.5 per- able from the National Academy Press, cent for frozen dairy products as de- 2101 Constitution Ave. NW., Wash- fined in § 170.3(n)(20) of this chapter; 97 ington, DC 20418, or available for in- percent for seasonings and flavorings spection at the Office of the Federal as defined in § 170.3(n)(26) of this chap- Register, 800 North Capitol Street, ter; 5 percent for nuts and nut products NW., suite 700, Washington, DC 20408. as defined in § 170.3(n)(32) of this chap- (c) In accordance with § 184.1(b)(1), ter; and 2.0 percent for all other food the ingredient is used in food with no categories. limitation other than current good (e) Prior sanctions for this ingredient manufacturing practice. The affirma- different from the uses established in tion of this ingredient as generally rec- this section do not exist or have been ognized as safe (GRAS) as a direct waived. human food ingredient is based upon the following current good manufac- [47 FR 27812, June 25, 1982] turing practice conditions of use: (1) The ingredient is used as a nutri- § 184.1670 Propylparaben. ent supplement as defined in (a) Propylparaben is the chemical § 170.3(o)(20) of this chapter. propyl p-hydroxybenzoate. It is pro- (2) The ingredient is used in the fol- duced by the n-propanol esterification lowing foods at levels not to exceed of p-hydroxybenzoic acid in the pres- current good manufacturing practice: ence of sulfuric acid, with subsequent baked goods as defined in § 170.3(n)(1) of distillation. 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
517
VerDate 06
formula in accordance with section by the Food and Drug Administration 412(g) of the Federal Food, Drug, and for this use. Cosmetic Act (the Act) or with regula- (4) Chymosin preparation is a clear tions promulgated under section solution containing the active enzyme 412(a)(2) of the Act. chymosin (E.C. 3.4.23.4). It is derived, (d) Prior sanctions for this ingredient via fermentation, from a nonpatho- different from the uses established in genic and nontoxigenic strain of Asper- 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- erichia coli K–12 containing the (c) In accordance with § 184.1(b)(1), prochymosin gene. The prochymosin is the ingredient is used in food with no isolated as an insoluble aggregate that limitation other than current good is acid-treated to destroy residual cel- manufacturing practice. The affirma- lular material and, after solubilization, tion of this ingredient as generally rec- is acid-treated to form chymosin. It ognized as safe as a direct human food must be processed with materials that ingredient is based upon the following are generally recognized as safe, or are current good manufacturing practice food additives that have been approved conditions of use: by the Food and Drug Administration (1) The ingredient is used as an en- for this use. zyme as defined in § 170.3(o)(9) of this (3) Chymosin preparation is a clear chapter; a processing aid as defined in solution containing the active enzyme § 170.3(o)(24) of this chapter; and a sta- chymosin (E.C. 3.4.23.4). It is derived, bilizer and thickener as defined in via fermentation, from a nonpatho- § 170.3(o)(28) of this chapter. 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.
518
VerDate 06
(d) Prior sanctions for this ingredient to orange-yellow crystals. It is pre- different from the uses established in pared by phosphorylation of riboflavin this section do not exist or have been with chlorophosphoric acid, waived. pyrophosphoric acid, metaphosphoric acid, or pyrocatechol cyclic phosphate. [55 FR 10935, Mar. 23, 1990, as amended at 57 (b) The ingredient meets the speci- FR 6479, Feb. 25, 1992; 58 FR 27202, May 7, 1993] fications of the Food Chemicals Codex, 3d Ed. (1981), p. 263, which is incor- § 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- [48 FR 51148, Nov. 7, 1983] ufacturing practice. The ingredient may also be used in infant formula in § 184.1698 Rue. accordance with section 412(g) of the (a) Rue is the perennial herb of sev- Federal Food, Drug, and Cosmetic Act eral species of ( L., (the Act) or with regulations promul- Ruta Ruta montana L., L., gated under section 412(a)(2) of the Act. Ruta graveolens Ruta bracteosa and Ruta calepensis L.). The leaves, (d) Prior sanctions for this ingredient buds, and stems from the top of the different from the uses established in plant are gathered, dried, and then this section do not exist or have been crushed in preparation for use, or left waived. whole. [48 FR 51148, Nov. 7, 1983] (b) The ingredient is used in all cat- egories of food in accordance with § 184.1697 Riboflavin–5′-phosphate (so- § 184.1(b)(2) of this chapter at con- dium). centrations not to exceed 2 parts per (a) Riboflavin-5′-phosphate (sodium) million. (C17H20N4O9PNa·2H2O, CAS Reg. No 130– (c) Prior sanctions for this ingredient 40–5) occurs as the dihydrate in yellow different from the uses established in
519
VerDate 06
this section do not exist or have been by reference in accordance with 5 waived. U.S.C. 552(a) and 1 CFR part 51. Copies [43 FR 3705, Jan. 27, 1978] are available from the National Acad- emy Press, Box 285, 2101 Constitution § 184.1699 Oil of rue. Ave. NW., Washington, DC 20055 (Inter- (a) Oil of rue is the natural substance net address ‘‘http://www.nap.edu’’), or obtained by steam distillation of the may be examined at the Center for fresh blossoming plants of rue, the pe- Food Safety and Applied Nutrition’s rennial herb of several species of Library, Food and Drug Administra- Ruta—Ruta montana L., Ruta graveolens tion, 200 C St. SW., rm. 3321, Wash- L., Ruta bracteosa L., and Ruta ington, DC, or at the Office of the Fed- calepensis L. eral Register, 800 North Capitol St. (b) Oil of rue meets the specifications NW., suite 700, Washington, DC. of the ‘‘Food Chemicals Codex,’’ 4th ed. (c) The ingredient is used in food (1996), pp. 342–343, which is incorporated 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 (c) In accordance with § 184.1(b)(3), different from the uses established in the ingredient is used in the following this section do not exist or have been food categories at levels not to exceed waived. current good manufacturing practice, [42 FR 14653, Mar. 15, 1977, as amended at 49 except that the ingredient may not be FR 5613, Feb. 14, 1984; 64 FR 1760, Jan. 12, used in a standardized food unless per- 1999] mitted by the standard of identity: Confections and frostings as defined in § 184.1702 Sheanut oil. § 170.3(n)(9) of this chapter, coatings of (a) Sheanut oil is produced from soft candy as defined in § 170.3(n)(38) of sheanuts derived from the Shea tree this chapter, and sweet sauces and top- Butyrospermum parkii and is composed pings as defined in § 170.3(n)(43) of this principally of triglycerides containing chapter. an oleic acid moiety at the 2-position and saturated fatty acids, usually ste- [63 FR 28895, May 27, 1998] aric or palmitic acids, at the 1- and 3- positions. § 184.1721 Sodium acetate.
(b) The ingredient meets the fol- (a) Sodium acetate (C2H3O2Na, CAS lowing specifications when tested using Reg. No. 127–09–3 or C2H3O2Na·3H2O, any appropriate validated method- CAS Reg. No. 6131–90–4) is the sodium ology: salt of acetic acid and occurs naturally (1) Saponification value of 185 to 195, in plant and animal tissues. Sodium ac- (2) Iodine value of 28 to 43, etate may occur in either the anhy- (3) Unsaponifiable matter not to ex- drous or trihydrated form. It is pro- ceed 1.5 percent, (4) Free fatty acids not more than 0.1 duced synthetically by the neutraliza- percent as oleic acid, tion of acetic acid with sodium car- (5) Peroxide value not more than 10 bonate or by treating calcium acetate milliequivalents/equivalent (meq/eq), with sodium sulfate and sodium bicar- (6) Lead not more than 0.1 part per bonate. million (ppm), (b) The ingredient meets the speci- (7) Copper not more than 0.1 ppm. fications of the Food Chemicals Codex,
520
VerDate 06
3d Ed. (1981), pp. 272, 273 which is incor- ter; 0.05 percent for soups and soup porated by reference. Copies are avail- mixes as defined in § 170.3(n)(40) of this able from the National Academy Press, chapter and sweet sauces as defined in 2101 Constitution Ave. NW., Wash- § 170.3(n)(43) of this chapter. ington, DC 20418, or available for in- (e) Prior sanctions for this ingredient spection at the Office of the Federal different from the uses established in Register, 800 North Capitol Street, this section do not exist or have been NW., suite 700, Washington, DC 20408. waived. (c) The ingredient is used as a fla- voring agent and adjuvant as defined in [47 FR 27815, June 25, 1982] § 170.3(o)(12) of this chapter; and as a pH § 184.1724 Sodium alginate. control agent as defined in § 170.3(o)(23) of this chapter. (a) Sodium alginate (CAS Reg. No. (d) The ingredient is used in food at 9005–38–3) is the sodium salt of alginic levels not to exceed current good man- acid, a natural polyuronide constituent ufacturing practice in accordance with of certain brown algae. Sodium algi- 184.1(b)(1). Current good manufacturing nate is prepared by the neutralization practice results in a maximum level, as of purified alginic acid with appro- served, of 0.007 percent for breakfast priate pH control agents. cereals as defined in § 170.3(n)(4) of this (b) The ingredient meets the speci- chapter; 0.5 percent for fats and oils as fications of the Food Chemicals Codex, defined in § 170.3(n)(12) of this chapter; 3d Ed. (1981), p. 274, which is incor- 0.6 percent for grain products and pas- porated by reference. Copies are avail- tas as defined in § 170.3(n)(23) of this able from the National Academy Press, chapter and snack foods as defined in 2101 Constitution Ave. NW., Wash- § 170.3(n)(37) of this chapter; 0.15 per- ington, DC 20418, or available for in- cent for hard candy as defined in spection at the Office of the Federal § 170.3(n)(25) of this chapter; 0.12 per- Register, 800 North Capitol Street, cent for jams and jellies as defined in NW., suite 700, Washington, DC 20408. § 170.3(n)(28) of this chapter and meat (c) In accordance with § 184.1(b)(2), products as defined in § 170.3(n)(29) of the ingredient is used in food only this chapter; 0.2 percent for soft candy within the following specific limita- as defined in § 170.3(n)(38) of this chap- 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- in this section do not exist or have nate different from the uses established been waived. [47 FR 29951, July 9, 1982, as amended at 48 FR 52448, Nov. 18, 1983]
521
VerDate 06
§ 184.1733 Sodium benzoate. (c) In accordance with § 184.1(b)(1), (a) Sodium benzoate is the chemical the ingredient is used in food with no limitation other than current good benzoate of soda (C7H5NaO2), produced by the neutralization of benzoic acid manufacturing practice. with sodium bicarbonate, sodium car- (d) Prior sanctions for this ingredient bonate, or sodium hydroxide. The salt different from the uses established in is not found to occur naturally. this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the ‘‘Food Chemicals [48 FR 52442, Nov. 18, 1983] Codex,’’ 3d Ed. (1981), p. 278, which is in- corporated by reference. Copies may be § 184.1742 Sodium carbonate. obtained from the National Academy 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 [42 FR 14653, Mar. 15, 1977, as amended at 49 human food ingredient is based upon FR 5613, Feb. 14, 1984] the following current good manufac- turing practice conditions of use: § 184.1736 Sodium bicarbonate. (1) The ingredient is used in food as (a) Sodium bicarbonate (NaHCO3, an antioxidant as defined in § 170.3(o)(3) CAS Reg. No. 144–55–8) is prepared by of this chapter; curing and pickling treating a sodium carbonate or a so- agent as defined in § 170.3(o)(5) of this dium carbonate and sodium bicarbon- chapter; flavoring agent and adjuvant ate solution with carbon dioxide. As as defined in § 170.3(o)(12) of this chap- carbon dioxide is absorbed, a suspen- ter; pH control agent as defined in sion of sodium bicarbonate forms. The § 170.3(o)(23) of this chapter; and proc- slurry is filtered, forming a cake which essing aid as defined in § 170.3(o)(24) of is washed and dried. this chapter. (b) The ingredient meets the speci- (2) The ingredient is used in food at fications of the Food Chemicals Codex, levels not to exceed current good man- 3d Ed. (1981), p. 278, which is incor- ufacturing practice. porated by reference. Copies are avail- (d) Prior sanctions for this ingredient 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- spection at the Office of the Federal waived. Register, 800 North Capitol Street, [48 FR 52442, Nov. 18, 1983, as amended at 50 NW., suite 700, Washington, DC 20408. FR 49536, Dec. 3, 1985]
522
VerDate 06
§ 184.1751 Sodium citrate. § 170.3(o)(2) of this chapter; flavoring agent and adjuvant as defined in (a) Sodium citrate (C6H5Na3O7·2H2O, CAS Reg. No. 68–0904–092) is the sodium § 170.3(o)(12) of this chapter; and pH salt of citric acid. It is prepared by control agent as defined in § 170.3(o)(23) neutralizing citric acid with sodium of this chapter. hydroxide or sodium carbonate. The (d) The ingredient is used in food at product occurs as colorless crystals or levels not to exceed current good man- a white crystalline powder. It may be ufacturing practice in accordance with prepared in an anhydrous state or may § 184.1(b)(1). Current good manufac- contain two moles of water per mole of turing practice results in a maximum sodium citrate. level, as served, 0.4 percent for baked (b) The ingredient meets the speci- goods as defined in § 170.3(n)(1) of this fications of the Food Chemicals Codex, chapter; 0.1 percent for fats and oils as 3d ed. (1981), pp. 283–284, which is incor- defined in § 170.3(n)(12) of this chapter, porated by reference in accordance meat products as defined in with 5 U.S.C. 552(a) and 1 CFR part 51. § 170.3(n)(29) of this chapter and soft Copies are available from the National candy as defined in § 170.3(n)(38) of this Academy Press, 2101 Constitution Ave. chapter; 0.25 percent for gravies and NW., Washington, DC 20418, and the sauces as defined in § 170.3(n)(24) of this Center for Food Safety and Applied Nu- chapter; and 0.05 percent for snack trition (HFS–200), 200 C St. SW., Wash- foods as defined in § 170.3(n)(37) of this ington, DC 20204, or may be examined chapter and soups and soup mixes as at the Office of the Federal Register, defined in § 170.3(n)(40) of this chapter. 800 North Capitol St. NW., suite 700, (e) Prior sanctions for this ingredient Washington, DC. 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 [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
(a) Sodium diacetate (C4H7O4Na·xH2O, and also by reacting calcium hydroxide 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:
523
VerDate 06
(1) The ingredient is used as a pH by the neutralization of lactic acid control agent as defined in § 170.3(o)(23) with sodium hydroxide. of this chapter and as a processing aid (b) FDA is developing food-grade as defined in § 170.3(o)(24) of this chap- specifications for sodium lactate in co- ter. operation with the National Academy (2) The ingredient is used in foods at of Sciences. In the interim, this ingre- levels not to exceed current good man- dient must be of a purity suitable for ufacturing practice. 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 limitation other than current good waived. manufacturing practice. This regula- [48 FR 52444, Nov. 18, 1983] tion does not authorize its use in in- 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 (NaH PO 2 2, 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 as colorless, pearly crystalline plates. (1) The ingredient is used as an emul- It is soluble in water, alcohol, and sifier as defined in § 170.3(o)(8) of this glycerol. It is prepared by neutraliza- chapter; a flavor enhancer as defined in tion of hypophosphorous acid or by di- § 170.3(o)(11) of this chapter; a flavoring rect aqueous alkaline hydrolysis of agent or adjuvant as defined in white phosphorus. § 170.3(o)(12) of this chapter; a humec- (b) FDA is developing food-grade tant as defined in § 170.3(o)(16) of this specifications for sodium chapter; and a pH control agent as de- hypophosphite in cooperation with the fined in § 170.3(o)(23) of this chapter. National Academy of Sciences. In the (2) The ingredient is used in food at interim, the ingredient must be of a levels not to exceed current good man- suitable purity for its intended use. ufacturing practice. (c) In accordance with § 184.1(b)(1), (d) Prior sanctions for this ingredient the ingredient is used in food with no different from the uses established in 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- [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- turing practice conditions of use: (a) Sodium metasilicate (CAS Reg. 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 §§ 170.3(o)(8) and 170.3(o)(28) of this rally but rather is synthesized by melt- chapter. ing sand with sodium carbonate at 1400 °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 (Na SiO ), the pentahydrate current good manufacturing practice. 2 3 (Na SiO ·5H O), and the nonahydrate (d) Prior sanctions for this ingredient 2 3 2 (Na SiO ·9H O). different from the use established in 2 3 2 this section do not exist or have been (b) FDA is developing food-grade waived. specifications for sodium metasilicate in cooperation with the National Acad- [47 FR 38277, Aug. 31, 1982] emy of Sciences. In the interim, the in- gredient must be of a purity suitable § 184.1768 Sodium lactate. for its intended use.
(a) Sodium lactate (C3H5O3Na, CAS (c) In accordance with § 184.1(b)(1), Reg. No. 72–17–3) is the sodium salt of the ingredient is used in food with no lactic acid. It is prepared commercially limitation other than current good
524
VerDate 06
manufacturing practice. The affirma- § 170.3(o)(2) of this chapter and a fla- tion of this ingredient as generally rec- voring agent as defined in § 170.3(o)(12) ognized as safe (GRAS) as a direct of this chapter. human food ingredient is based upon (2) The ingredient is used in the fol- the following current good manufac- lowing foods at levels not to exceed turing practice conditions of use: current good manufacturing practice: (1) The ingredient is used as a proc- baked goods as defined in § 170.3(n)(1) of essing aid as defined in § 170.3(o)(24) of this chapter; nonalcoholic beverages as this chapter. defined in § 170.3(n)(3) of this chapter; (2) The ingredient is used to treat the following foods at levels not to exceed cheeses as defined in § 170.3(n)(5) of this current good manufacturing practice: chapter; confections and frostings as for use in washing and lye peeling of defined in § 170.3(n)(9) of this chapter; fruits, vegetables, and nuts when used gelatins, puddings, and fillings as de- in accordance with § 173.315 of this fined in § 170.3(n)(22) of this chapter; chapter; for use as a denuding agent in jams and jellies as defined in tripe; for use as a hog scald agent in re- § 170.3(n)(28) of this chapter; meat prod- moving hair; and for use as a corrosion ucts as defined in § 170.3(n)(29) of this preventative in canned and bottled chapter; and soft candy as defined in water when used in accordance with § 170.3(n)(38) of this chapter. § 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. § 184.1784 Sodium propionate. (a) Sodium sesquicarbonate
(a) Sodium propionate (C3H5NaO2, (Na2CO3·NaHCO3·2H2O, CAS Reg. No. CAS Reg. No. 137–40–6) is the sodium 533–96–0) is prepared by: (1) Partial salt of propionic acid. It occurs as carbonation of soda ash solution fol- colorless, transparent crystals or a lowed by crystallization, centrifuga- granular crystalline powder. It is odor- tion, and drying; (2) double refining of less, or has a faint acetic-butyric acid trona ore, a naturally occurring im- 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. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no the ingredient is used in food with no limitation other than current good limitation other than current good manufacturing practice. The affirma- manufacturing practice. The affirma- tion of this ingredient as generally rec- tion of this ingredient as generally rec- ognized as safe (GRAS) as a direct ognized as safe (GRAS) as a direct human food ingredient is based upon human food ingredient is based upon the following current good manufac- the following current good manufac- turing practice conditions of use: turing practice conditions of use: (1) The ingredient is used as a pH (1) The ingredient is used as an anti- control agent as defined in § 170.3(o)(23) microbial agent as defined in of this chapter.
525
VerDate 06
(2) The ingredient is used in cream at § 184.1804 Sodium potassium tartrate. levels not to exceed current good man- (a) Sodium potassium tartrate ufacturing practice. Current good man- (C4H4KNaO6·4H2O, CAS Reg. No. 304–59– ufacturing practice utilizes a level of 6) is the sodium potassium salt of the ingredient sufficient to control lac- L¥(+)¥tartaric acid and is also called tic acid prior to pasteurization and the Rochelle salt. It occurs as colorless churning of cream into butter. crystals or as a white, crystalline pow- (d) Prior sanctions for this ingredient der and has a cooling saline taste. It is different from the uses established in obtained as a byproduct of wine manu- this section do not exist or have been facture. waived. (b) The ingredient meets the speci- fications of the Food Chemicals Codex, [48 FR 52443, Nov. 18, 1983] 3d Ed. (1981), p. 296, which is incor- § 184.1801 Sodium tartrate. porated by reference. Copies are avail- able from the National Academy Press, (a) Sodium tartrate (C4H4Na2O6·2H2O, 2101 Constitution Ave. NW., Wash- CAS Reg. No. 868–18–8) is the disodium ington, DC 20418, or available for in- salt of L¥(+)¥tartaric acid. It occurs spection at the Office of the Federal as transparent, colorless, and odorless Register, 800 North Capitol Street, crystals. It is obtained as a byproduct NW., suite 700, Washington, DC 20408. of wine manufacture. (c) In accordance with § 184.1(b)(1), (b) The ingredient meets the speci- the ingredient is used in food with no fications of the Food Chemicals Codex, limitation other than current good 3d Ed. (1981), p. 303, 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 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. (d) Prior sanctions for this ingredient turing practice conditions of use: different from the uses established in (1) The ingredient is used as an emul- this section do not exist or have been sifier as defined in § 170.3(o)(8) of this waived. chapter and as a pH control agent as defined in § 170.3(o)(23) of this chapter. [48 FR 52447, Nov. 18, 1983] (2) The ingredient is used in the fol- § 184.1807 Sodium thiosulfate. lowing foods at levels not to exceed 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- fications of the ‘‘Food Chemicals waived. Codex,’’ 3d Ed. (1981), p. 304, which is in- [48 FR 52447, Nov. 18, 1983] corporated by reference. Copies may be
526
VerDate 06
obtained from the National Academy tion aid as defined in § 170.3(o)(14) of Press, 2101 Constitution Ave. NW., this chapter, humectant as defined in Washington, DC 20418, or may be exam- § 170.3(o)(16) of this chapter, lubricant ined at the Office of the Federal Reg- and release agent as defined in ister, 800 North Capitol Street, NW., § 170.3(o)(18) of this chapter, nutritive suite 700, Washington, DC 20408. sweetener as defined in § 170.3(o)(21) of (c) The ingredient is used as a formu- this chapter, sequestrant as defined in lation aid as defined in § 170.3(o)(14) of § 170.3(o)(26) of this chapter, stabilizer this chapter and reducing agent as de- and thickener as defined in § 170.3(o)(28) fined in § 170.3(o)(22) of this chapter. of this chapter, surface-finishing agent (d) The ingredient is used in alco- as defined in § 170.3(o)(30) of this chap- holic beverages and table salt in ac- ter, and texturizer as defined in cordance with § 184.1(b)(1) at levels not § 170.3(o)(32) of this chapter. 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- [43 FR 22938, May 30, 1978, as amended at 49 standardized jams and jellies, commer- 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 hexanehexol (C6H14O6), a hexahydric al- dairy desserts and mixes as defined in 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., Washington, DC 20418, or may be exam- [42 FR 14653, Mar. 15, 1977, as amended at 49 ined at the Office of the Federal Reg- FR 5613, Feb. 14, 1984] ister, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. § 184.1845 Stannous chloride (anhy- (c) The ingredient is used as an drous and dihydrated). anticaking agent and free-flow agent as (a) Stannous chloride is anhydrous or defined in § 170.3(o)(1) of this chapter, contains two molecules of water of hy- curing and pickling agent as defined in dration. Anhydrous stannous chloride § 170.3(o)(5) of this chapter, drying (SnCl2, CAS Reg. No. 7772–99–8) is the agent as defined in § 170.3(o)(7) of this chloride salt of metallic tin. It is pre- chapter, emulsifier and emulsifier salt pared by reacting molten tin with ei- as defined in § 170.3(o)(8) of this chap- ther chlorine or gaseous tin tetra- ter, firming agent as defined in chloride. Dihydrated stannous chloride § 170.3(o)(10) of this chapter, flavoring (SnCl2·2H2O, CAS Reg. No. 10025–0969– agent and adjuvant as defined in 091) is the chloride salt of metallic tin § 170.3(o)(12) of this chapter, formula- that contains two molecules of water.
527
VerDate 06
It is prepared from granulated tin sus- manufacturing practice. The affirma- pended in water and hydrochloric acid tion of this ingredient as generally rec- or chlorine. ognized as safe (GRAS) as a direct (b) Both forms of the ingredient meet human food ingredient is based upon the specifications of the Food Chemi- the following current good manufac- cals Codex, 3d Ed. (1981), p. 312, which is turing practice conditions of use: incorporated by reference. Copies are (1) The ingredient is used as a fla- available from the National Academy voring agent and adjuvant as defined in Press, 2101 Constitution Ave. NW., § 170.3(o)(12) of this chapter. Washington, DC 20418, or available for (2) The ingredient is used in food at inspection at the Office of the Federal levels not to exceed current good man- Register, 800 North Capitol Street, ufacturing practice. NW., suite 700, Washington, DC 20408. (d) Prior sanctions for this ingredient (c) The ingredient is used as an anti- different from the uses established in oxidant as defined in § 170.3(o)(3) of this this section do not exist or have been chapter. waived. (d) The ingredient is used in food at levels not to exceed current good man- [48 FR 51907, Nov. 15, 1983] ufacturing practice in accordance with § 184.(b)(1). Current good manufacturing § 184.1851 Stearyl citrate. practice results in a maximum level, as (a) Stearyl citrate is a mixture of the served, of 0.0015 percent or less; cal- mono-, di-, and tristearyl esters of cit- culated as tin, for all food categories. ric acid. It is prepared by esterifying (e) Prior sanctions for this ingredient citric acid with stearyl alcohol. different from those uses established in (b) The Food and Drug Administra- this section do not exist or have been tion, in cooperation with the National waived. 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
528
VerDate 06
forth in part 181 of this chapter, do not (d) Prior sanctions for this ingredient exist or have been waived. different from the uses established in this section do not exist or have been [59 FR 63897, Dec. 12, 1994] waived. § 184.1854 Sucrose. [53 FR 44876, Nov. 7, 1988]
(a) Sucrose (C12H22O11, CAS Reg. No. 57–50–11–1) sugar, cane sugar, or beet § 184.1859 Invert sugar. sugar is the chemical β-D- (a) Invert sugar (CAS Reg. No. 8013– fructofuranosyl-α-D-glucopyranoside. 17–0) is an aqueous solution of inverted Sucrose is obtained by crystallization or partly inverted, refined or partly re- from sugar cane or sugar beet juice fined sucrose, the solids of which con- that has been extracted by pressing or tain not more than 0.3 percent by 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 (b) FDA is developing food-grade its intended use. specifications for invert sugar in co- (c) In accordance with § 184.1(b)(1), operation with the National Academy the ingredient is used in food with no of Sciences. In the interim, this ingre- limitation other than current good dient must be of a purity suitable for manufacturing practice. 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 limitation other than current good waived. manufacturing practice. (d) Prior sanctions for this ingredient [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, 1989] different from the uses established in this section do not exist or have been § 184.1857 Corn sugar. waived.
(a) Corn sugar (C6H12O6, CAS Reg. No. [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, 50–99–7), commonly called D-glucose or 1989] dextrose, is the chemical α-D- glucopyranose. It occurs as the anhy- § 184.1865 Corn syrup. drous or the monohydrate form and is (a) Corn syrup, commonly called produced by the complete hydrolysis of ‘‘glucose sirup’’ or ‘‘glucose syrup,’’ is corn starch with safe and suitable acids obtained by partial hydrolysis of corn or enzymes, followed by refinement and starch with safe and suitable acids or crystallization from the resulting hy- enzymes. It may also occur in the de- drolysate. hydrated form (dried glucose sirup). (b) The ingredient meets the speci- Depending on the degree of hydrolysis, fications of the Food Chemicals Codex, corn syrup may contain, in addition to 3d Ed. (1981), pp. 97–98 under the head- glucose, maltose and higher ing ‘‘Dextrose,’’ which is incorporated saccharides. by reference in accordance with 5 (b) The ingredient meets the speci- U.S.C. 552(a) and 1 CFR part 1. Copies fications as defined and determined in are available from the National Acad- § 168.120(b) or § 168.121(a) of this chapter, emy Press, 2101 Constitution Ave., NW., as appropriate. FDA, in cooperation Washington, DC 20418, or available for with the National Academy of inspection at the Office of the Federal Sciences, is undertaking a study to de- Register, 800 North Capitol Street, termine if additional food-grade speci- NW., suite 700, Washington, DC 20408. fications for corn syrup are necessary. (c) In accordance with § 184.1(b)(1), (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no the ingredient is used in food with no limitation other than current good limitation other than current good manufacturing practice. manufacturing practice.
529
VerDate 06
(d) Prior sanctions for this ingredient 3d Ed. (1981), p. 324, which is incor- different from the uses established in porated by reference. Copies are avail- this section do not exist or have been able from the National Academy Press, waived. 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- [53 FR 44876, Nov. 7, 1988] spection at the Office of the Federal § 184.1866 High fructose corn syrup. Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (a) High fructose corn syrup, a sweet, (c) In accordance with § 184.1(b)(1), nutritive saccharide mixture con- the ingredient is used in food with no taining either approximately 42 or 55 limitation other than current good percent fructose, is prepared as a clear manufacturing practice. The affirma- aqueous solution from high dextrose- tion of this ingredient as generally rec- equivalent corn starch hydrolysate by ognized as safe (GRAS) as a direct partial enzymatic conversion of glu- human food ingredient is based upon cose (dextrose) to fructose using an in- the following current good manufac- soluble glucose isomerase enzyme prep- turing practice conditions of use: aration described in § 184.1372. The (1) The ingredient is used as a fla- product containing more than 50 per- voring agent and adjuvant as defined in cent fructose (dry weight) is prepared § 170.3(o)(12) of this chapter or as a nu- through concentration of the fructose trient supplement as defined in portion of the mixture containing less § 170.3(o)(20) of this chapter. than 50 percent fructose. (2) The ingredient is used in food at (b) The ingredient shall conform to levels not to exceed current good man- the identity and specifications listed in ufacturing practice. Thiamine hydro- the monograph entitled ‘‘High-Fruc- chloride may be used in infant formula tose Corn Syrup’’ in the Food Chemi- in accordance with section 412(g) of the cals Codex, 4th ed. (1996), pp. 191–192, Federal Food, Drug, and Cosmetic Act which is incorporated by reference in (the Act) or with regulations promul- accordance with 5 U.S.C. 552(a) and 1 gated under section 412(a)(2) of the Act. CFR part 51. Copies are available from (d) Prior sanctions for this ingredient the Office of Premarket Approval, Cen- different from the uses established in ter for Food Safety and Applied Nutri- this section do not exist or have been tion (HFS–200), Food and Drug Admin- waived. istration, 200 C St. SW., Washington, [48 FR 55124, Dec. 9, 1983] DC 20204–0001, or may be examined at the Center for Food Safety and Applied § 184.1878 Thiamine mononitrate. Nutrition’s Library, 200 C St. SW., rm. 3321, Washington, DC, or at the Office (a) Thiamine mononitrate of the Federal Register, 800 North Cap- (C12H17N5O4S, CAS Reg. No. 532–43–4) is the mononitrate salt of thiamine. It itol St. NW., suite 700, Washington, DC. occurs as white crystals or a white (c) In accordance with § 184.1(b)(1), crystalline powder and is prepared the ingredient is used in food with no from thiamine hydrochloride by dis- limitation other than current good solving the hydrochloride salt in alka- manufacturing practice. line solution followed by precipitation [61 FR 43450, Aug.23, 1996] of the nitrate half-salt with a stoichio- metric amount of nitric acid. § 184.1875 Thiamine hydrochloride. (b) The ingredient meets the speci- (a) Thiamine hydrochloride fications of the Food Chemicals Codex, (C12H17C1N4OS·HCl, CAS Reg. No. 67–03– 3d Ed. (1981), p. 325, which is incor- 8) is the chloride-hydrochloride salt of porated by reference. Copies are avail- thiamine. It occurs as hygroscopic able from the National Academy Press, white crystals or a white crystalline 2101 Constitution Ave. NW., Wash- powder. The usual method of preparing ington, DC 20418, or available for in- this substance is by linking the spection at the Office of the Federal preformed thiazole and pyrimidine ring Register, 800 North Capitol Street, systems. NW., suite 700, Washington, DC 20408. (b) The ingredient meets the speci- (c) In accordance with § 184.1(b)(1), fications of the Food Chemicals Codex, the ingredient is used in food with no
530
VerDate 06
limitation other than current good the agency concludes the general eval- manufacturing practice. The affirma- uation of all food uses of tocopherols: tion of this ingredient as generally rec- (1) The ingredients are used as inhibi- ognized as safe (GRAS) as a direct tors of nitrosamine formation. human food ingredient is based upon (2) The ingredients are used in pump- the following current good manufac- cured bacon at levels not to exceed cur- turing practice conditions of use: rent good manufacturing practice. (1) The ingredient is used as a nutri- [49 FR 13348, Apr. 4, 1984] ent supplement as defined in § 170.3(o)(20) of this chapter. § 184.1901 Triacetin. (2) The ingredient is used in food at (a) Triacetin (C H O CAS Reg. No. levels not to exceed current good man- 8 14 6, 102–76–1), also known as 1,2,3,- ufacturing practice. Thiamine mono- propanetriol triacetate or glyceryl nitrate may be used in infant formula triacetate, is the triester of glycerin in accordance with section 412(g) of the and acetic acid. Triacetin can be pre- Federal Food, Drug, and Cosmetic Act pared by heating glycerin with acetic (the Act) or with regulations promul- anhydride alone or in the presence of gated under section 412(a)(2) of the Act. finely divided potassium hydrogen sul- (d) Prior sanctions for this ingredient fate. It can also be prepared by the re- different from the uses established in action of oxygen with a liquid-phase this section do not exist or have been mixture of allyl acetate and acetic acid waived. using a bromide salt as a catalyst. [48 FR 55124, Dec. 9, 1983] (b) The ingredient meets the speci- fications of the Food Chemicals Codex, α § 184.1890 -Tocopherols. 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 (1) d-α-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
531
VerDate 06
as defined in § 170.3(n)(3) of this chap- gelatins, puddings and fillngs as de- ter; chewing gum as defined in fined in § 170.3(n)(22) of this chapter; § 170.3(n)(6) of this chapter; confections and soft candy as defined in and frostings as defined in § 170.3(n)(9) § 170.3(n)(38) of this chapter. 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 § 170.3(n)(25) of this chapter; and soft [54 FR 7404, Feb. 21, 1989; 54 FR 10482, Mar. 13, candy as defined in § 170.3(n)(38) of this 1989] chapter. (d) Prior sanctions for this ingredient § 184.1911 Triethyl citrate.
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 [54 FR 7404, Feb. 21, 1989] citric acid with ethyl alcohol and oc- curs as an odorless, practically color- § 184.1903 Tributyrin. less, oily liquid.
(a) Tributyrin (C15H26O6, CAS Reg. (b) The ingredient meets the speci- No. 60–01–5), also known as butyrin or fications of the Food Chemicals Codex, glyceryl tributyrate, is the triester of 3d ed. (1981), p. 339, which is incor- glycerin and butyric acid. It is pre- porated by reference in accordance pared by esterification of glycerin with with 5 U.S.C. 552(a) and 1 CFR part 51. excess butyric acid. Copies are available from the National (b) The ingredient meets the speci- Academy Press, 2101 Constitution Ave. fication of the Food Chemicals Codex, NW., Washington, DC 20418, and the 3d Ed. (1981), p. 416, which is incor- Center for Food Safety and Applied Nu- porated by reference in accordance trition (HFS–200), 200 C St. SW., Wash- with 5 U.S.C. 552(a). Copies are avail- ington, DC 20204, or may be examined able from the National Academy Press, at the Office of the Federal Register, 2101 Constitution Ave. NW., Wash- 800 North Capitol St. NW., suite 700, ington, DC 20418, or available for in- Washington, DC. spection at the Office of the Federal Register, 800 North Capitol Street, (c) In accordance with § 184.1(b)(1), NW., suite 700, Washington, DC 20005. 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 generaly 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 fla- turing practice conditions of use: voring agent as defined in § 170.3(o)(12) (1) The ingredient is used in food as a of this chapter; a solvent and vehicle as flavoring agent and adjuvant as defined defined in § 170.3(o)(27) of this chapter; in § 170.3(o)(12) of this chapter. and a surface-active agent as defined in (2) The ingredient is used in the fol- § 170.3(o)(29) of this chapter. lowing foods at levels not to exceed (2) The ingredient is used in foods at current good manufacturing practice; levels not to exceed current good man- baked goods as defined in § 170.3(n)(1) of ufacturing practice. this chapter; alcoholic beverages as de- (d) Prior sanctions for this ingredient fined in § 170.3(n)(2) of this chapter; different from the uses established in nonalcoholic beverages as defined in this section, or different from those set § 170.3(n)(3) of this chapter; fats and oils forth in part 181 of this chapter, do not as defined in § 170.3(n)(12) of this chap- exist or have been waived. ter; frozen dairy desserts and mixes as defined in § 170.3(n)(20) of this chapter; [59 FR 63897, Dec. 12, 1994]
532
VerDate 06
§ 184.1914 Trypsin. ognized as safe as a direct human food ingredient is based upon the following (a) Trypsin (CAS Reg. No. 9002–07–7) current good manufacturing practice is an enzyme preparation obtained conditions of use: from purified extracts of porcine or bo- (1) The ingredient is used as a formu- vine pancreas. It is a white to tan lation aid as defined in § 170.3(o)(14) of amorphous powder. Its characterizing this chapter and as a fermentation aid. enzyme activity is that of a peptide hy- (2) The ingredient is used in yeast- drolase (EC 3.4.21.4). raised bakery products; in alcoholic (b) The ingredient meets the general beverages as defined in § 170.3(n)(2) of requirements and additional require- this chapter; and in gelatin products. ments for enzyme preparations in the (d) Prior sanctions for this ingredient Food Chemicals Codex, 3d ed. (1981), p. different from the uses established in 110, which is incorporated by reference this section do not exist or have been in accordance with 5 U.S.C. 552(a) and 1 waived. CFR part 51. Copies are available from the National Academy Press, 2101 Con- [48 FR 51616, Nov. 10, 1983, as amended at 49 stitution Ave. NW., Washington, DC FR 19816, May 10, 1984] 20418, or may be examined at the Office § 184.1924 Urease enzyme preparation of Premarket Approval (HFS–200), Food from Lactobacillus fermentum. and Drug Administration, 200 C St. SW., Washington, DC, and the Office of (a) This enzyme preparation is de- the Federal Register, 800 North Capitol rived from the nonpathogenic, St. NW., suite 700, Washington, DC. nontoxicogenic bacterium Lactobacillus (c) In accordance with § 184.1(b)(1), fermentum. It contains the enzyme the ingredient is used in food with no urease (CAS Reg. No. 9002–13–5), which limitation other than current good facilitates the hydrolysis of urea to manufacturing practice. The affirma- 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 accordance with 5 U.S.C. 552(a) and 1 [60 FR 32911, June 26, 1995] CFR part 51. Copies are available from the National Academy Press, 2101 Con- § 184.1923 Urea. stitution Ave. NW., Washington, DC (a) Urea (CO(NH2)2, CAS Reg. No. 57– 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.
533
VerDate 06
(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 is limited to use of waived. this ingredient in wine to inhibit for- mation of ethyl carbamate. [48 FR 51610, Nov. 10, 1983]
[57 FR 60473, Dec. 21, 1992] § 184.1945 Vitamin B12. (a) Vitamin B also known as cyano- § 184.1930 Vitamin A. 12, cobalamin (C63H88CoN14O14P, CAS Reg. (a)(1) Vitamin A (retinol; CAS Reg. No. 68–0919–099), is produced commer- No. 68–26–8) is the alcohol 9,13-di- cially from cultures of Streptomyces methyl-7-(1,1,5-trimethyl-6-cyclohexen- griseus. 5-yl)-7,9,11,13-nonatetraen-15-ol. It may (b) The ingredient meets the speci- be nearly odorless or have a mild fishy fications of the Food Chemicals Codex, odor. Vitamin A is extracted from fish 3d Ed. (1981), p. 343, which is incor- liver oils or produced by total syn- porated by reference. Copies are avail- thesis from β-ionone and a propargyl able from the National Academy Press, halide. 2101 Constitution Ave. NW., Wash- (2) Vitamin A acetate (retinyl ace- ington, DC 20418, or available for in- tate; CAS Reg. No. 127–47–9) is the ace- spection at the Office of the Federal tate ester of retinol. It is prepared by Register, 800 North Capitol Street, esterifying retinol with acetic acid. NW., suite 700, Washington, DC 20408. (3) Vitamin A palmitate (retinyl (c) In accordance with § 184.1(b)(1), palmitate; CAS Reg. No. 79–81–2) is the the ingredient is used in food with no palmitate ester of retinol. It is pre- limitation other than current good pared by esterifying retinol with pal- manufacturing practice. The affirma- mitic acid. tion of this ingredient as generally rec- (b) The ingredient meets the speci- ognized as safe (GRAS) as a direct fications for vitamin A in the Food human food ingredient is based upon Chemicals Codex, 3d Ed. (1981), p. 342, the following current good manufac- which is incorporated by reference. turing practice conditions of use: Copies are available from the National (1) The ingredient is used as a nutri- Academy Press, 2101 Constitution Ave. ent supplement as defined in NW., Washington, DC 20418, or avail- § 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: (1) The ingredient is used in food as a [50 FR 6341, Feb. 15, 1985] nutrient supplement as defined in § 170.3(o)(20) of this chapter. § 184.1950 Vitamin D. (2) The ingredient is used in foods at (a) Vitamin D is added to food as the levels not to exceed current good man- following food ingredients: ufacturing practice. Vitamin A may be (1) Crystalline vitamin D2 (C28H44O, used in infant formula in accordance CAS Reg. No. 50–14–6), also known as with section 412(g) of the Federal Food, ergocalciferol, is the chemical 9,10- Drug, and Cosmetic Act (the act) or seco(5Z,7E,22E)-5,7,10(19),22- with regulations promulgated under ergostatetraen-3-ol. The ingredient is section 412(a)(2) of the Act. produced by ultraviolet irradiation of
534
VerDate 06
ergosterol isolated from yeast and re- Category of food Maximum levels in Functional use lated fungi and is purified by crys- food (as served) tallization. Milk products, 89 (IU/100 grams) Do. (2) Crystalline vitamin D3 (C27H44O, § 170.3(n)(31) of CAS Reg. No. 67–97–0), also known as this chapter. cholecalciferol, is the chemical 9,10- (2) Vitamin D may be used in infant seco(5Z,7E,)-5,7,10(19)-cholestatrien-3- formula in accordance with section ol. Vitamin D3 occurs in, and is iso- 412(g) of the Federal Food, Drug, and lated from, fish liver oils. It is also Cosmetic Act (the act) or with regula- manufactured by ultraviolet irradia- tions promulgated under section tion of 7-dehydrocholesterol produced 412(a)(2) of the act. from cholesterol. It is purified by crys- (3) Vitamin D may be used in mar- tallization. Vitamin D3 is the vitamin garine in accordance with § 166.110 of D form that is produced endogenously this chapter. in humans through sunlight activation (d) Prior sanctions for these ingredi- of 7-dehydrocholesterol in the skin. ents different from the uses established (3) Vitamin D2 resin and vitamin D3 in this section do not exist or have resin are the concentrated forms of ir- been waived. radiated ergosterol (D ) and irradiated 2 [50 FR 30152, July 24, 1985] 7-dehydrocholesterol (D3) that are sepa- rated from the reacting materials in § 184.1973 Beeswax (yellow and white). paragraphs (a) (1) and (2) of this sec- tion. The resulting products are sold as (a) Beeswax (CAS Reg. No. 8012–89–3) is a secretory product of honey bees food sources of vitamin D without fur- used as a structural material in honey- ther purification. combs. Beeswax is prepared from hon- (b) Vitamin D and vitamin D as 2 3 eycombs after removal of the honey by crystals meet the specifications of the draining or centrifuging. The combs Food Chemicals Codex, 3d Ed. (1981), are melted in hot water or steam or pp. 344 and 345, which is incorporated with solar heat, and strained. The wax by reference. Copies are available from is refined by melting in hot water to the National Academy Press, 2101 Con- which sulfuric acid or alkali may be stitution Ave. NW., Washington, DC added to extract impurities. The re- 20418, or available for inspection at the sulting wax is referred to as yellow Office of the Federal Register, 800 beeswax. White beeswax is produced by North Capitol Street, NW., suite 700, bleaching the constituent pigments of Washington, DC 20408. FDA is devel- yellow beeswax with peroxides, or pref- oping food-grade specifications for vi- erably it is bleached by sun light. tamin D2 resin and vitamin D3 resin in (b) The ingredient meets the speci- cooperation with the National Acad- fications of the ‘‘Food Chemicals emy of Sciences. In the interim, these Codex,’’ 3d Ed. (1981), pp. 34–35, which is resins must be of a purity suitable for incorporated by reference. Copies may their intended use. be obtained from the National Acad- (c)(1) In accordance with § 184.1(b)(2), emy Press, 2101 Constitution Ave. NW., the ingredients are used in food as the Washington, DC 20418, or may be exam- sole source of added vitamin D only ined at the Office of the Federal Reg- within the following specific limita- ister, 800 North Capitol Street, NW., tions: suite 700, Washington, DC 20408. (c) The ingredient is used as a fla- Maximum levels in Category of food food (as served) Functional use voring agent and adjuvant as defined in § 170.3(o)(12) of this chapter, as a lubri- Breakfast cereals, 350 (IU/100 Nutrient supple- cant as defined in § 170.3(o)(18) of this § 170.3(n)(4) of grams). ment, chapter, and as a surface-finishing this chapter. § 170.3(o)(20) of this chapter. agent as defined in § 170.3(o)(30) of this Grain products and 90(IU/100 grams) Do. chapter. pastas, (d) The ingredient is used in food, in § 170.3(n)(23) of accordance with § 184.1(b)(1) of this this chapter. Milk, § 170.3(n)(30) 42 (IU/100 grams) Do. chapter, at levels not to exceed good of this chapter. manufacturing practice. Current good
535
VerDate 06
manufacturing practice results in a (d) Prior sanctions for this ingredient maximum level, as served, of: 0.065 per- different from the uses established in cent for chewing gum as defined in this section do not exist or have been § 170.3(n)(6) of this chapter; 0.005 per- waived. cent for confections and frostings as [48 FR 51617, Nov. 10, 1983] defined in § 170.3(n)(9) of this chapter; 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: manufacturing practice. The affirma- (1) The ingredient is used as an tion of this ingredient as generally rec- anticaking agent as defined § 170.3(o)(1) ognized as safe (GRAS) as a direct of this chapter; as a formulation aid as human food ingredient is based upon defined in § 170.3(o)(14) of this chapter; the following current good manufac- as a lubricant and release agent as de- turing practice conditions of use: fined in § 170.3(o)(18) of this chapter; (1) The ingredient is used as a lubri- and as a surface-finishing agent as de- cant as defined in § 170.3(o)(18) of this fined in § 170.3(o)(30) of this chapter. chapter and as a surface-finishing (2) The ingredient is used in the fol- agent as defined in § 170.3(o)(30) of this lowing foods at levels not to exceed chapter. current good manufacturing practice: (2) The ingredient is used in the fol- baked goods and baking mixes as de- lowing foods at levels not to exceed fined in § 170.3(n)(1) of this chapter; current good manufacturing practice: chewing gun as defined in § 170.3(n)(6) of in chewing gum as defined in this chapter; confections and frostings § 170.3(n)(6) of this chapter and in hard as defined in § 170.3(n)(9) of this chap- candy as defined in § 170.3(n)(25) of this ter; fresh fruits and fruit juices as de- chapter. fined in § 170.3(n)(16) of this chapter;
536
VerDate 06
gravies and sauces as defined in tion of Official Analytical Chemists § 170.3(n)(24) of this chapter; processed International, 481 North Frederick fruits and fruit juices as defined in Ave., suite 500, Gaithersburg, MD 20877– § 170.3(n)(35) of this chapter; and soft 2504, or may be examined at the Center candy as defined in § 170.3(n)(38) of this for Food Safety and Applied Nutri- chapter. tion’s Library, Food and Drug Admin- (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), (a)(1) Whey. Whey is the liquid sub- entitled ‘‘Total Nitrogen—Official stance obtained by separating the co- Final Action’’ under the heading 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
537
VerDate 06
in section 16.023, entitled ‘‘Acidity (2)— techniques such as precipitation, filtra- Official Final Action’’ under the head- tion, or dialysis. As with whey, reduced ing ‘‘Milk,’’ or by an equivalent poten- lactose whey can be used as a fluid, tiometric method. concentrate, or a dry product form. (2) Limits of impurities are: Heavy The acidity of reduced lactose whey metals (as lead). Not more than 10 may be adjusted by the addition of safe parts per million (0.001 percent) as de- and suitable pH-adjusting ingredients. termined by the method described in (b) The reduced lactose whey meets the ‘‘Food Chemicals Codex,’’ 4th ed. the following specifications: (1996), pp. 760–761, which is incorporated (1) The analysis of reduced lactose by reference in accordance with 5 whey, on a dry product basis, based on U.S.C. 552(a) and 1 CFR part 51. Copies analytical methods in the referenced are available from the National Acad- sections of ‘‘Official Methods of Anal- emy Press, Box 285, 2101 Constitution ysis of the Association of Official Ana- Ave. NW., Washington, DC 20055 (Inter- lytical Chemists,’’ 13th ed. (1980), which net address ‘‘http://www.nap.edu’’), or is incorporated by reference in accord- may be examined at the Center for ance with 5 U.S.C. 552(a) and 1 CFR Food Safety and Applied Nutrition’s part 51, is given in paragraphs (b)(1)(i) Library, Food and Drug Administra- through (b)(1)(vii) of this section. Cop- tion, 200 C St. SW., rm. 3321, Wash- ies may be obtained from the Associa- ington, DC, or at the Office of the Fed- tion of Official Analytical Chemists eral Register, 800 North Capitol St. International, 481 North Frederick NW., suite 700, Washington, DC. Ave., suite 500, Gaithersburg, MD 20877– (3) The whey must be derived from 2504, or may be examined at the Center milk that has been pasteurized, or the for Food Safety and Applied Nutri- whey and modified whey product must tion’s Library, Food and Drug Admin- be subjected to pasteurization tech- istration, 200 C St. SW., rm. 3321, Wash- niques or its equivalent before use in ington, DC, or at the Office of the Fed- food. eral Register, 800 North Capitol St. (c) Whey, concentrated whey, and dry NW., suite 700, Washington, DC. (dried) whey may be used in food in ac- (i) Protein content, 16 to 24 percent— cordance with good manufacturing as determined by the methods pre- practice as indicated in § 184.1(b)(1). scribed in section 16.036 (liquid sample), (d) The label on the whey form sold entitled ‘‘Total Nitrogen—Official to food manufacturers shall read as fol- Final Action’’ under the heading lows: ‘‘Total Solids,’’ or in section 16.193 (dry (1) For whey: ‘‘(Sweet or acid) whey’’ sample), entitled ‘‘Kjeldahl Method’’ or ‘‘whey (ll% titratable acidity). under the heading ‘‘Protein—Official (2) For concentrated whey: ‘‘Con- Final Action.’’ centrated (sweet or acid) whey, ll% (ii) Fat content, 1 to 4 percent—as de- solids’’ or ‘‘Concentrated whey (ll% termined by the methods prescribed in titratable acidity), ll% solids’’. section 16.059 (liquid sample), ‘‘Reese- (3) For dry (dried) whey: ‘‘Dry (dried) Gottlieb Method [Reference Method] (sweet or acid) whey’’ or ‘‘dry (dried) (11)—Official Final Action’’ under the whey, (ll% titratable acidity)’’. 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
538
VerDate 06
sample), entitled ‘‘Gravimetric Meth- increments, expressed as a multiple of od—Official Final Action’’ under the 5, not greater than the actual percent- heading ‘‘Lactose,’’ or in section 31.061 age of lactose in the product, or as a (dry sample), entitled ‘‘Lane–Eynon actual percentage provided that an General Volumetric Method’’ under the analysis of the product on which the 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’’
539
VerDate 06
under the heading ‘‘Protein—Official Food Safety and Applied Nutrition’s Final Action.’’ Library, Food and Drug Administra- (ii) Fat content, 1 to 4 percent—as de- tion, 200 C St. SW., rm. 3321, Wash- termined by the methods prescribed in ington, DC, or at the Office of the Fed- section 16.059 (liquid sample), ‘‘Reese- eral Register, 800 North Capitol St. Gottlieb Method [Reference Method] NW., suite 700, Washington, DC. (11)—Official Final Action’’ under the (3) The reduced minerals whey shall heading ‘‘Fat,’’ or in section 16.199 (dry be derived from milk that has been pas- sample), entitled ‘‘Fat in Dried Milk teurized, or the reduced minerals whey (45)—Official Final Action.’’ shall be subjected to pasteurization (iii) Ash content, maximum 7 per- techniques or its equivalent before use cent—as determined by the methods in food. prescribed in section 16.035 (liquid sam- (c) The reduced minerals whey may ple), entitled ‘‘Ash (5)—Official Final be used in food in accordance with good Action’’ under the heading ‘‘Total Sol- manufacturing practice as indicated in ids,’’ or in section 16.196 (dry sample), § 184.1(b)(1). entitled ‘‘Ash—Official Final Action’’ (d) The percent of minerals present under the heading ‘‘Dried Milk, Nonfat on a dry product basis, i.e., ‘‘reduced Dry Milk, and Malted Milk.’’ 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’’ [46 FR 44441, Sept. 4, 1981, as amended at 54 under the heading ‘‘Dried Milk, Nonfat FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, Dry Milk, and Malted Milk.’’ 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.
540
VerDate 06
(1980), which is incorporated by ref- (vi) Solids content, variable—as de- erence in accordance with 5 U.S.C. termined by the methods prescribed in 552(a) and 1 CFR part 51, is given in section 16.032, entitled ‘‘Method I—Offi- paragraphs (b)(1)(i) through (b)(1)(vii) cial Final Action’’ under the heading of this section. Copies may be obtained ‘‘Total Solids.’’ from the Association of Official Ana- (vii) Titratable Acidity, variable—as lytical Chemists International, 481 determined by the methods prescribed North Frederick Ave., suite 500, Gai- in section 16.023, entitled ‘‘Acidity (2)— thersburg, MD 20877–2504, or may be ex- Official Final Action’’ under the head- amined at the Center for Food Safety ing ‘‘Milk,’’ or by an equivalent poten- and Applied Nutrition’s Library, Food tiometric method. and Drug Administration, 200 C St. (2) Limits of impurities are: Heavy SW., rm. 3321, Washington, DC, or at metals (as lead). Not more than 10 the Office of the Federal Register, 800 parts per million (0.001 percent), as de- North Capitol St. NW., suite 700, Wash- termined by the method described in ington, DC. the ‘‘Food Chemicals Codex,’’ 4th ed. (i) Protein content, minimum 25 per- (1996), pp. 760–761, which is incorporated cent—as determined by the methods prescribed in section 16.036 (liquid sam- by reference in accordance with 5 ple), entitled ‘‘Total Nitrogen—Offi- U.S.C. 552(a) and 1 CFR part 51. Copies cials Final Action’’ under the heading are available from the National Acad- ‘‘Total Solids,’’ or in section 16.193 (dry emy Press, Box 285, 2101 Constitution sample), entitled ‘‘Kjeldahl Method’’ Ave. NW., Washington, DC 20055 (Inter- under the heading ‘‘Protein—Official net address ‘‘http://www.nap.edu’’), or Final Action.’’ may be examined at the Center for (ii) Fat content, 1 to 10 percent—as Food Safety and Applied Nutrition’s determined by the methods prescribed Library, Food and Drug Administra- in section 16.059 (liquid sample), tion, 200 C St. SW., rm. 3321, Wash- ‘‘Reese-Gottlieb Method [Reference ington, DC, or at the Office of the Fed- Method] (11)—Official Final Action’’ eral Register, 800 North Capitol St. under the heading ‘‘Fat,’’ or in section NW., suite 700, Washington, DC. 16.199 (dry sample), entitled ‘‘Fat in (3) The whey protein concentrate Dried Milk (45)—Official Final Action.’’ shall be derived from milk that has (iii) Ash content, 2 to 15 percent—as been pasteurized, or the whey protein determined by the methods prescribed concentrate shall be subjected to pas- in section 16.035 (liquid sample), enti- teurization techniques or its equiva- tled ‘‘Ash (5)—Official Final Action’’ lent before use in food. under the heading ‘‘Total Solids,’’ or in (c) The whey protein concentrate section 16.196 (dry sample), entitled may be used in food in accordance with ‘‘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 ‘‘Moisture (41)—Official Final Action’’ turer. under the heading ‘‘Dried Milk, Nonfat (e) The presence of whey protein con- Dry Milk, and Malted Milk.’’ centrate in a finished food product
541
VerDate 06
shall be listed as ‘‘whey protein con- manufacturing practice. The affirma- centrate’’. tion of this ingredient as generally rec- ognized as safe (GRAS) as a direct [46 FR 44441, Sept. 4, 1981, as amended at 54 FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, human food ingredient is based upon 1999] the following current good manufac- turing practice conditions of use: § 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 tion is derived from the nonpathogenic by aerobic plate count. and nontoxicogenic bacterium (2) Less than 10 yeasts and molds/ Lactococcus lactis (previously named gram. Streptococcus lactis). The preparation (3) Negative for Salmonella, E. coli, contains the enzyme aminopeptidase coagulase positive Staphylococci, Clos- (CAS Reg. No. 9031–94–1; EC 3.4.11.1) and tridium perfringens, Clostridium botu- other peptidases that hydrolyze milk linum, or any other recognized micro- proteins. The preparation is produced bial pathogen or any harmful microbial by pure culture fermentation. toxin. (b) The ingredient meets the speci- (d) The ingredient is used as a fla- fications for enzyme preparations in voring agent and adjuvant as defined in the Food Chemicals Codex, 3d ed. (1981), § 170.3(o)(12) of this chapter at a level pp. 107–110, which are incorporated by not to exceed 5 percent in food. reference in accordance with 5 U.S.C. (e) This regulation is issued prior to 552(a) and 1 CFR part 51. Copies are general evaluation of use of this ingre- available from the National Academy dient in order to affirm as GRAS the Press, 2101 Constitution Ave. NW., specific use named. Washington, DC 20418, or may be exam- ined at the Division of Petition Control § 184.1984 Zein. (HFS–215), Center for Food Safety and (a) Zein (CAS Reg. No. 9010–66–6) is Applied Nutrition, Food and Drug Ad- one of the components of corn gluten. ministration, 1110 Vermont Ave. NW., It is produced commercially by extrac- suite 1200, Washington, DC, or at the tion from corn gluten with alkaline Office of the Federal Register, 800 aqueous isopropyl alcohol containing North Capitol St. NW., suite 700, Wash- sodium hydroxide. The extract is then ington, DC. cooled, which causes the zein to pre- (c) In accordance with § 184.1(b)(1), cipitate. the ingredient is used in food with no (b) FDA is developing food-grade limitations other than current good specifications for zein in cooperation manufacturing practice. The affirma- with the National Academy of tion of this ingredient as generally rec- Sciences. In the interim, the igredient ognized as safe as a direct human food must be of a purity suitable for its in- ingredient is based upon the following tended use. current good manufacturing practice (c) In accordance with § 184.1(b)(1), 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
542
VerDate 06
chapter, as an optional ingredient for gredients in this part may also be used flavor development in the manufacture in food-contact surfaces in accordance of cheddar cheese, in accordance with with parts 174, 175, 176, 177, 178 or § 133.113 of this chapter, and in the § 179.45 of this chapter. Ingredients af- preparation of protein hydrolysates. firmed as GRAS for direct use in part (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 food ingredient to a food. They author- PART 186—INDIRECT FOOD SUB- 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- tice includes the requirements that an Subpart B—Listing of Specific Substances indirect human food ingredient be of a Affirmed as GRAS 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. intended technical effect in the food- 186.1300 Ferric oxide. contact article. 186.1316 Formic acid. (1) If the ingredient is affirmed as 186.1374 Iron oxides. GRAS with no limitations on its condi- 186.1551 Hydrogenated fish oil. 186.1555 Japan wax. tions of use other than current good 186.1557 Tall oil. manufacturing practice, it shall be re- 186.1673 Pulp. garded as GRAS if its conditions of use 186.1750 Sodium chlorite. are consistent with the requirements of 186.1756 Sodium formate. paragraphs (b), (c), and (d) of this sec- 186.1770 Sodium oleate. tion. When the Food and Drug Admin- 186.1771 Sodium palmitate. istration (FDA) determines that it is 186.1797 Sodium sulfate. 186.1839 Sorbose. appropriate, the agency will describe one or more current good manufac- AUTHORITY: 21 U.S.C. 321, 342, 348, 371. turing practice conditions of use in the SOURCE: 42 FR 14658, Mar. 15, 1977, unless regulation that affirms the GRAS sta- otherwise noted. tus of the indirect ingredient. For ex- ample, when the safety of an ingredient Subpart A—General Provisions has been evaluated on the basis of lim- ited conditions of use, the agency will § 186.1 Substances added indirectly to describe in the regulation that affirms human food affirmed as generally the GRAS status of the indirect ingre- recognized as safe (GRAS). dient, one or more of these limited con- (a) The indirect human food ingredi- ditions of use, which may include the ents listed in this part have been re- category of food-contact surface(s), viewed by the Food and Drug Adminis- technical effect(s) or functional use(s) tration and determined to be generally of the indirect ingredient, and the recognized as safe (GRAS) for the pur- level(s) of use. If the ingredient is used poses and under the conditions pre- under conditions that are significantly scribed, providing they comply with different from those described in the the purity specifications listed in this regulation, such use of a substance part or, in the absence of purity speci- may not be GRAS. In such a case, a fications, are of a purity suitable for manufacturer may not rely on the reg- their intended use in accordance with ulation as authorizing that use but § 170.30(h)(1) of this chapter. Certain in- shall independently establish that the
543
VerDate 06
use is GRAS or shall use the ingredient notice will also constitute a proposal in accordance with a food additive reg- to establish a regulation under part 181 ulation. Persons seeking FDA approval of this chapter, incorporating the same of an independent determination that a provisions, in the event that such a 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- Subpart B—Listing of Specific face(s), the functional use(s) of the in- gredient, and the level(s) of use. Any Substances Affirmed as GRAS use of such an ingredient not in full § 186.1093 Sulfamic acid. compliance with each such established 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. (b) In accordance with § 186.1(b)(1), other uses may also be GRAS. the ingredient is used as an indirect (c) The listing of a food ingredient in food ingredient with no limitations this part does not authorize the use of other than current good manufacturing such substance for the purpose of add- practice. The affirmation of this ingre- ing the ingredient to the food through dient as generally recognized as safe extraction from the food-contact sur- (GRAS) as an indirect human food in- face. gredient is based upon the current good (d) The listing of a food ingredient in manufacturing practice of using this this part does not authorize the use of ingredient in the manufacture of paper such substance in a manner that may and paperboard that contact food. lead to deception to the consumer or to (c) Prior sanctions for this ingredient any other violation of the Federal different from the uses established in Food, Drug, and Cosmetic Act (the this section do not exist or have been Act). waived. (e) If the Commissioner of Food and Drugs is aware of any prior sanction [47 FR 29954, July 9, 1982] for use of an ingredient under condi- tions different from those proposed to § 186.1256 Clay (kaolin). be affirmed as GRAS, he will concur- (a) Clay (kaolin) Al2O3.2SiO2.nH2O, Cas rently propose a separate regulation Reg. No. 1332–58–7) consists of hydrated covering such use of the ingredient aluminum silicate. The commercial under part 181 of this chapter. If the products of clay (kaolin) contain vary- Commissioner is unaware of any such ing quantities of alkalies and alkaline applicable prior sanction, the proposed earths. Clay (kaolin) is a white to yel- regulation will so state and will re- lowish or grayish fine powder. There quire any person who intends to assert are at least three different minerals, or rely on such sanction to submit kaolinite, dickite, and nacrite, classi- proof of its existence. Any regulation fied as kaolin. Kaolinite or china clay promulgated pursuant to this section is whiter, less contaminated with ex- constitutes a determination that ex- traneous minerals, and less plastic in cluded uses would result in adultera- water. tion of the food in violation of section (b) In accordance with § 186.1(b)(1), 402 of the Act, and the failure of any the ingredient is used as an indirect person to come forward with proof of human food ingredient with no limita- such an applicable prior sanction in re- tion other than current good manufac- sponse to the proposal will constitute a turing practice. The affirmation of this waiver of the right to assert or rely on ingredient as generally recognized as such sanction at any later time. The safe (GRAS) as an indirect human food
544
VerDate 06
ingredient is based upon the following (1) The ingredient is used as a con- current good manufacturing practice stituent of paper and paperboard used conditions of use: for food packaging. (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 [53 FR 16867, May 12, 1988; 53 FR 20939, June this regulation do not exist or have 7, 1988] been waived. [47 FR 43367, Oct. 1, 1982] § 186.1316 Formic acid. (a) Formic acid (CH2O2, CAS Reg. No. § 186.1275 Dextrans. 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 [45 FR 22915, Apr. 4, 1980] different from the uses established in this section do not exist or have been § 186.1374 Iron oxides. waived. (a) Iron oxides (oxides of iron, CAS [43 FR 29288, July 7, 1978, as amended at 48 Reg. No. 97705–33–85) are undefined mix- FR 48457, Oct. 19, 1983] tures of iron (II) oxide (CAS Reg. No. 1345–25–1, black cubic crystals) and iron § 186.1300 Ferric oxide. (III) oxide (CAS Reg. No. 1309–37–1, red- (a) Ferric oxide (iron (III) oxide, brown to black trigonal crystals). Fe2O3, CAS Reg. No. 1309–37–1) occurs (b) In accordance with § 186.1(b)(1), naturally as the mineral hematite. It the ingredient is used as an indirect may be prepared synthetically by heat- human food ingredient with no limita- ing brown iron hydroxide oxide. The tion other than current good manufac- product is red-brown to black trigonal turing practice. The affirmation of this crystals. ingredient as generally recognized as (b) In accordance with § 186.1(b)(1), safe (GRAS) as an indirect human food the ingredient is used as an indirect ingredient is based upon the following human food ingredient with no limita- current good manufacturing practice tion other than current good manufac- conditions of use: turing practice. The affirmation of this (1) The ingredient is used as a con- ingredient as generally recognized as stituent of paper and paperboard used safe (GRAS) as an indirect human food for food packaging. ingredient is based upon the following (2) The ingredient is used at levels current good manufacturing practice not to exceed current good manufac- conditions of use: turing practice.
545
VerDate 06
(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 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 succedanea (Japan, Taiwan, and Indo- 7, 1988] 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 (1) The ingredient is used as a con- greater than 32 °C as determined by stituent of cotton and cotton fabrics Section Cc 1–25, Official and Tentative used for dry food packaging. Methods of the American Oil Chemists’ (2) The ingredient is used at levels Society method (reapproved 1973) or not to exceed current good manufac- equivalent. The product has an approx- turing practice. imate fatty acid composition of 30 to 45 (c) Prior sanctions for this ingredient percent saturated fatty acids, 40 to 55 different from the uses established in percent monoenoic fatty acids, 7 to 15 this section do not exist or have been percent dienoic fatty acids, 3 to 10 per- waived. cent trienoic fatty acids, and less than [60 FR 62208, Dec. 5, 1995] 2 percent tetraenoic or higher polyenoic fatty acids. The approximate § 186.1557 Tall oil. percentages of total fatty acids by car- bon chain length are 15 to 30 percent (a) Tall oil (CAS Reg. No. 8002–26–4) is essentially the sap of the pine tree. It each of C C C C less than 10 per- 16, 18, 20, 22, is obtained commercially from the cent C or lower carbon chain length, 14 waste liquors of pinewood pulp mills and less than 1 percent C or higher 24 and consists mainly of tall oil resin carbon chain length fatty acids. acids and tall oil fatty acids. (c) The ingredient is used as a con- (b) In accordance with § 186.1(b)(1), stituent of cotton and cotton fabrics the ingredient is used as an indirect used for dry food packaging. human food ingredient with no limita- (d) The ingredient is used at levels tion other than current good manufac- not to exceed good manufacturing turing practice. The affirmation of this practice in accordance with § 186.1(b)(1). ingredient as generally recognized as (e) Prior sanctions for this ingredient safe (GRAS) as an indirect human food different from the use established in ingredient is based on the following this section do not exist or have been current good manufacturing practice waived. conditions of use: [44 FR 28323, May 15, 1979, as amended at 49 (1) The ingredient is used as a con- FR 5614, Feb. 14. 1984; 58 FR 17099, Apr. 1, stituent of cotton and cotton fabrics 1993] used for dry food packaging. (2) The ingredient is used at levels § 186.1555 Japan wax. not to exceed current good manufac- (a) Japan wax (CAS Reg. No. 8001–39– turing practice. 6), also known as Japan tallow or (c) Prior sanctions for this ingredient sumac wax, is a pale yellow vegetable different from the uses established in
546
VerDate 06
this section, or from those listed in with a slight tallow-like odor. Com- 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- aging and as a component of lubricants side the stem of a plant such as wood, with incidental food contact in accord- straw, sugarcane, or other natural ance with § 178.3570 of this chapter, plant sources. with no limitation other than current (b) The ingredient is used or intended good manufacturing practice. for use as a constituent of food pack- (c) Prior sanctions for this ingredient aging containers. different from the uses established in (c) The ingredient is used in paper this section do not exist or have been and paperboard made by conventional waived. paper-making processes at levels not to 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 salt of palmitic acid (hexadecanoic § 186.1750 Sodium chlorite. 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 different from the uses established in [45 FR 16470, Mar. 14, 1980] this section do not exist or have been § 186.1756 Sodium formate. waived.
(a) Sodium formate (CHNaO2, CAS [51 FR 39372, Oct. 28, 1986] Reg. No. 141–53–7) is the sodium salt of formic acid. It is produced by the reac- § 186.1797 Sodium sulfate. tion of carbon monoxide with sodium (a) Sodium sulfate (Na2SO4, CAS Reg. hydroxide. No. 7757–82–6), also known as Glauber’s (b) The ingredient is used as a con- salt, occurs naturally and exists as stituent of paper and paperboard used colorless crystals or as a fine, white for food packaging. crystalline powder. It is prepared by (c) The ingredient is used at levels the neutralization of sulfuric acid with not to exceed good manufacturing sodium hydroxide. practice in accordance with § 186.1(b)(1). (b) The ingredient is used as a con- (d) Prior sanctions for sodium for- stituent of paper and paperboard used mate different from the uses estab- for food packaging, and cotton and cot- lished in this section do not exist or ton fabric used for dry food packaging. have been waived. (c) The ingredient is used at levels [45 FR 22915, Apr. 4, 1980] not to exceed good manufacturing practice in accordance with § 186.1(b)(1). § 186.1770 Sodium oleate. (d) Prior sanctions for this ingredient different from the uses established in (a) Sodium oleate (C18H33O2Na, CAS 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 [45 FR 6086, Jan. 25, 1980]
547
VerDate 06
§ 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- mountain ash (Sorbus aucuparia) where mercaptoimidazoline. 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 Acetobacter xylinum or by Acetobacter SOURCE: 42 FR 14659, Mar. 15, 1977, unless suboxydans. otherwise noted. (b) The ingredient is used or intended EDITORIAL NOTE: Nomenclature changes to for indirect food use as a constituent of part 189 appear at 61 FR 14482, Apr. 2, 1996. cotton, cotton fabrics, paper, and pa- perboard in contact with dry food. Subpart A—General Provisions (c) The ingredient migrates to food at § 189.1 Substances prohibited from use levels not to exceed good manufac- in human food. turing practice. (d) Prior sanctions for this ingredient (a) The food ingredients listed in this 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 [43 FR 11698, Mar. 21, 1978, as amended at 48 risk to the public health or have not FR 48457, Oct. 19, 1983] been shown by adequate scientific data to be safe for use in human food. Use of PART 189—SUBSTANCES PROHIB- any of these substances in violation of ITED FROM USE IN HUMAN FOOD this section causes the food involved to be adulterated in violation of the act. (b) This section includes only a par- Subpart A—General Provisions tial list of substances prohibited from Sec. use in human food, for easy reference 189.1 Substances prohibited from use in purposes, and is not a complete list of human food. substances that may not lawfully be used in human food. No substance may Subpart B—Substances Generally Prohib- be used in human food unless it meets ited From Direct Addition or Use as all applicable requirements of the act. Human Food (c) The Commissioner of Food and Drugs, either on his own initiative or 189.110 Calamus and its derivatives. on behalf of any interested person who 189.113 Cinnamyl anthranilate. has submitted a petition, may publish 189.120 Cobaltous salts and its derivatives. a proposal to establish, amend, or re- 189.130 Coumarin. peal a regulation under this section on 189.135 Cyclamate and its derivatives. the basis of new scientific evaluation 189.140 Diethylpyrocarbonate (DEPC). or information. Any such petition shall 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. 189.191 Chlorofluorocarbon propellants. [42 FR 14659, Mar. 15, 1977, as amended at 54 FR 24899, June 12, 1989]
548
VerDate 06
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 (a) Calamus is the dried rhizome of as a foam stabilizer and to prevent ‘‘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.
549
VerDate 06
(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
550
VerDate 06
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),
551
VerDate 06
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]
552
VerDate 06
§ 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 Special Nutritionals (HFS–450), Center (i.e., as a covering applied over the for Food Safety and Applied Nutrition, cork and neck areas) on wine bottles to Food and Drug Administration, 200 C prevent insect infestation, as a barrier St. SW., Washington, DC 20204, infor- to oxygen, and for decorative purposes. mation including any citation to pub- Information received by the Food and lished articles that is the basis on Drug Administration establishes that which the manufacturer or distributor the use of such a capsule on wine bot- has concluded that a dietary supple- tles may reasonably be expected to re- ment containing such dietary ingre- sult in lead becoming a component of dient will reasonably be expected to be the wine. safe. An original and two copies of this (b) The capping of any bottles of wine notification shall be submitted. after February 8, 1996, with a tin-coat- (b) The notification required by para- ed lead foil capsule renders the wine graph (a) of this section shall include: adulterated and in violation of section (1) The name and complete address of 402(a)(2)(C) of the Federal Food, Drug, the manufacturer or distributor of the and Cosmetic Act because lead from dietary supplement that contains a the capsule, which is an unsafe food ad- new dietary ingredient, or of the new ditive within the meaning of section dietary ingredient; 409 of the act, may reasonably be ex- (2) The name of the new dietary in- pected to become a component of the gredient that is the subject of the pre- wine. market notification, including the Latin binomial name (including the au- [61 FR 4820, Feb. 8, 1996] thor) of any herb or other botanical; (3) A description of the dietary sup- PART 190—DIETARY SUPPLEMENTS plement or dietary supplements that contain the new dietary ingredient in- Subpart A [Reserved] cluding: (i) The level of the new dietary ingre- Subpart B—New Dietary Ingredient dient in the dietary supplement; and Notification (ii) The conditions of use rec- Sec. ommended or suggested in the labeling 190.6 Requirement for premarket notifica- of the dietary supplement, or if no con- tion. ditions of use are recommended or sug- gested in the labeling of the dietary AUTHORITY: Secs. 201(ff), 301, 402, 413, 701 of the Federal Food, Drug, and Cosmetic Act supplement, the ordinary conditions of (21 U.S.C. 321(ff), 331, 342, 350b, 371). use of the supplement; (4) The history of use or other evi- SOURCE: 62 FR 49891, Sept. 23, 1997, unless dence of safety establishing that the otherwise noted. dietary ingredient, when used under the conditions recommended or sug- Subpart A [Reserved] gested in the labeling of the dietary supplement, will reasonably be ex- Subpart B—New Dietary pected to be safe, including any cita- Ingredient Notification tion to published articles or other evi- dence that is the basis on which the § 190.6 Requirement for premarket no- distributor or manufacturer of the die- tification. tary supplement that contains the new (a) At least 75 days before intro- dietary ingredient has concluded that ducing or delivering for introduction the new dietary supplement will rea- into interstate commerce a dietary sonably be expected to be safe. Any ref- supplement that contains a new die- erence to published information offered tary ingredient that has not been in support of the notification shall be present in the food supply as an article accompanied by reprints or photostatic
553
VerDate 06
copies of such references. If any part of responses made to inquiries from the the material submitted is in a foreign agency, to determine whether they are language, it shall be accompanied by substantive and whether they require an accurate and complete English that the 75-day period be reset. If the translation; and agency determines that the new sub- (5) The signature of the person des- mission is a substantive amendment, ignated by the manufacturer or dis- FDA will assign a new filing date. FDA tributor of the dietary supplement that will acknowledge receipt of the addi- contains a new dietary ingredient. tional information and, when applica- (c) FDA will acknowledge its receipt ble, notify the manufacturer of the new of a notification made under section filing date, which is the date of receipt 413 of the Federal Food, Drug, and Cos- by FDA of the information that con- metic Act (the act) and will notify the stitutes the substantive amendment. submitter of the date of receipt of such (e) FDA will not disclose the exist- a notification. The date that the agen- ence of, or the information contained cy receives the notification submitted in, the new dietary ingredient notifica- under paragraph (a) of this section is tion for 90 days after the filing date of the filing date for the notification. For the notification. After the 90th day, all 75 days after the filing date, the manu- information in the notification will be facturer or distributor of a dietary sup- placed on public display, except for any plement that contains a new dietary information that is trade secret or oth- ingredient shall not introduce, or de- erwise confidential commercial infor- liver for introduction, into interstate mation. commerce the dietary supplement that contains the new dietary ingredient. (f) Failure of the agency to respond (d) If the manufacturer or distributor to a notification does not constitute a of a dietary supplement that contains a finding by the agency that the new die- new dietary ingredient, or of the new tary ingredient or the dietary supple- dietary ingredient, provides additional ment that contains the new dietary in- information in support of the new die- gredient is safe or is not adulterated tary ingredient notification, the agen- under section 402 of the act. cy will review all submissions per- taining to that notification, including PARTS 191–199 [RESERVED]
554
VerDate 06
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
555
VerDate 06
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 Public Health Association 1015 15th St., NW, Washington, DC 20005 Standard Methods for the Examination of Water and Wastewater, 173.69 18th Ed. (1992) – Method 4500-CIO2 E. 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. 557
VerDate 06
558
VerDate 06
559
VerDate 06
AOAC International (Association of Official Analytical Chemists) 481 N. Frederick Ave., Suite 500, Gaithersburg, MD 20877-2407 Telephone: (301) 924–7077 Journal of the Association of Official Analytical Chemists Changes in Methods: ‘‘Glycyrrhizic Acid or Glycyrrhizic Acid Salts 184.1408 in Licorice’’ Vol. 65, pp. 471–472 (1982). ‘‘Flavors and Nonalcoholic Beverages’’ Vol. 56(5) 1281–1283 (1973) 189.110(c)
560
VerDate 06
National Academy of Sciences, National Research Council 2101 Constitution Ave. NW., Washington, DC 20037. 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;
561
VerDate 06
562
VerDate 06
563
VerDate 06
564
VerDate 06
565
VerDate 06
NOTE: The following materials are available through the Food and Drug Administration at the addresses indicated.
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’’.
566
VerDate 06
567
VerDate 06
568
VerDate 06
569
VerDate 06
570
VerDate 06
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) II Federal Claims Collection Standards (General Accounting Of- fice—Department of Justice) (Parts 100—299)
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) IV Advisory Committee on Federal Pay (Parts 1400—1499) 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)
571
VerDate 06
XXII Federal Deposit Insurance Corporation (Part 3201) XXIII Department of Energy (Part 3301) XXIV Federal Energy Regulatory Commission (Part 3401) XXV Department of the Interior (Part 3501) XXVI Department of Defense (Part 3601) 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) 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
572
VerDate 06
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)
573
VerDate 06
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—499)
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)
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) II Federal Reserve System (Parts 200—299) III Federal Deposit Insurance Corporation (Parts 300—399)
574
VerDate 06
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 Department of Commerce, Economic Development Administra- tion, (Parts 300—399)
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) IV Foreign-Trade Zones Board, Department of Commerce (Parts 400—499) VII Bureau of Export Administration, Department of Commerce (Parts 700—799)
575
VerDate 06
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)
576
VerDate 06
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 United States Information Agency (Parts 500—599) VII Overseas Private Investment Corporation, International Devel- opment Cooperation Agency (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)
577
VerDate 06
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 Multifamily Housing Assistance Restructuring, Depart- ment of Housing and Urban Development (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)
578
VerDate 06
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 (Part 1001) 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)
Title 29—Labor
SUBTITLE A—OFFICE OF THE SECRETARY OF LABOR (PARTS 0—99) SUBTITLE B—REGULATIONS RELATING TO LABOR I National Labor Relations Board (Parts 100—199) II Office of Labor-Management Standards, Department of Labor (Parts 200—299) III National Railroad Adjustment Board (Parts 300—399) IV Office of Labor-Management Standards, Department of Labor (Parts 400—499) V Wage and Hour Division, Department of Labor (Parts 500—899) IX Construction Industry Collective Bargaining Commission (Parts 900—999) X National Mediation Board (Parts 1200—1299)
579
VerDate 06
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)
Title 32—National Defense
SUBTITLE A—DEPARTMENT OF DEFENSE I Office of the Secretary of Defense (Parts 1—399) V Department of the Army (Parts 400—699) VI Department of the Navy (Parts 700—799)
580
VerDate 06
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) 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) XXIX Presidential Commission on the Assignment of Women in the Armed Forces (Part 2900)
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)
581
VerDate 06
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) XIV Assassination Records Review Board (Parts 1400-1499)
Title 37—Patents, Trademarks, and Copyrights
I 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) V Council on Environmental Quality (Parts 1500—1599)
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)
582
VerDate 06
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) 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 (Parts 303–1—303–2) 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)
Title 43—Public Lands: Interior
SUBTITLE A—OFFICE OF THE SECRETARY OF THE INTERIOR (PARTS 1—199) SUBTITLE B—REGULATIONS RELATING TO PUBLIC LANDS I Bureau of Reclamation, Department of the Interior (Parts 200— 499) II Bureau of Land Management, Department of the Interior (Parts 1000—9999)
583
VerDate 06
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) XXII Christopher Columbus Quincentenary Jubilee Commission (Parts 2200—2299) 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)
584
VerDate 06
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 United States Information Agency (Parts 1900—1999) 20 Nuclear Regulatory Commission (Parts 2000—2099) 21 Office of Personnel Management, Federal Employees Group Life Insurance Federal Acquisition Regulation (Parts 2100—2199) 23 Social Security Administration (Parts 2300—2399) 24 Department of Housing and Urban Development (Parts 2400— 2499) 25 National Science Foundation (Parts 2500—2599) 28 Department of Justice (Parts 2800—2899) 29 Department of Labor (Parts 2900—2999)
585
VerDate 06
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 Highway 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) 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)
586
VerDate 06
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
587
VerDate 06
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 Committee on Federal Pay 5, IV Advisory Council on Historic Preservation 36, VIII African Development Foundation 22, XV Federal Acquisition Regulation 48, 57 Agency for International Development 22, II Federal Acquisition Regulation 48, 7 Agricultural Marketing Service 7, I, IX, X, XI Agricultural Research Service 7, V Agriculture Department 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
589
VerDate 06
590
VerDate 06
591
VerDate 06
592
VerDate 06
593
VerDate 06
594
VerDate 06
595
VerDate 06
596
VerDate 06
597
VerDate 06
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
599
VerDate 06
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
601
VerDate 06
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 175.300 (b)(3)(xxxii) amended...... 41987 25025 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
602
VerDate 06
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
603
VerDate 06
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
604
VerDate 06
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, 13878, 17705, 39357 177.1020 (c)(2) and (d)(2) amend- 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
605
VerDate 06
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
606
VerDate 06
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
607
VerDate 06
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 172.811 (b) revised...... 24924 (c)(23) added...... 21099 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
608
VerDate 06
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 179.45 (b)(4)(i), (6)(i), (d)(2)(ii), (iii) (b)(3)(xxxiii) amended...... 57339 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
609
VerDate 06
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
610
VerDate 06
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
611
VerDate 06
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 172.665 (d)(2) revised ...... 1758 176.170 (b)(2) table amended...... 69551 172.723 (b)(3) revised ...... 1759 176.180 (b)(2) table amended...... 59709, 173.25 (b)(5) and (d)(2) revised...... 14609 63408 173.310 (c) table amended ...... 1759 177.1390 (c)(2)(vii) added; 175.300 (b)(3)(vii)(a) corrected; (c)(3)(i)(a)(1) revised ...... 55943 CFR correction ...... 4535 177.1430 (b) table amended ...... 36175 175.320 (b)(3) table amended ...... 2568 177.1500 (b) table amended ...... 6854 177.1520 (a)(1) redesignated as 177.1390 (c)(1)(i)(e) redesignated (a)(1)(i); (a)(1)(ii) added; (c) as (c)(1)(i)(f); new (c)(1)(i)(e) amended ...... 6853 added ...... 4785 177.2415 Added ...... 20315 177.1500 (b) table amended ...... 4786 177.2460 (c)(1) amended ...... 8852 177.1520 (c) table amended ...... 10944 177.2600 (c)(4)(i) amended...... 8572 178.2010 (b) table amended ...... 34, 2854, 178.2010 (b) table amended ...... 8853 13507 (b) table amended.....27836, 29136, 35135, 178.3130 (b) corrected; CFR cor- 36177, 36178, 43875, 45716, 55945 rection...... 4535 (b) table corrected; CFR correc- 178.3620 (c)(3) corrected; CFR cor- tion...... 49285 rection...... 4535 178.3130 (b) table amended ...... 38748 178.3910 (a)(2) table corrected; 178.3295 Table amended...... 56789, 68392 CFR correction ...... 4535 178.3297 (e) table amended...... 3464 184.1007 (b)(1), (6) and (7) re- (e) table amended.....43874, 55946, 59215, vised ...... 1759 59710 184.1257 (b) introductory text and 178.3400 (c) table amended ...... 29551 (1) revised...... 1759 178.3725 Table amended...... 35799 184.1259 (b)(3) revised...... 1760 179 Technical correction...... 46388 179.26 (c)(1) amended...... 43876 184.1282 (b) revised...... 1760 184.1420 Added ...... 24419 184.1293 (b) revised...... 1760 184.1444 (a) amended; (b)(3) 184.1428 (a) amended ...... 405 added...... 14611 184.1530 (b) revised...... 1760 184.1702 Added ...... 28895 184.1699 (b) revised...... 1760 184.1979 (b)(1) introductory text 1999 and (2) revised ...... 1760 184.1979a (b)(1) introductory text (Regulations published from January 1, and (2) revised ...... 1761 1999, through April 1, 1999) 184.1979b (b)(1) introductory text 21 CFR 64 FR and (2) revised ...... 1761 Page Corrected ...... 7066 Chapter I 184.1979c (b)(1) introductory text 172.345 (b) revised ...... 1758 and (2) revised ...... 1761
Æ
612
VerDate 06