Subchapter B—Food for Human Consumption (Continued)

SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 170—FOOD ADDITIVES 170.106 Notification for a food contact substance formulation (NFCSF).

Subpart A—General Provisions Subpart E—Generally Recognized as Safe Sec. (GRAS) Notice 170.3 Definitions. 170.203 Definitions. 170.6 Opinion letters on food additive sta- 170.205 Opportunity to submit a GRAS no- tus. tice. 170.10 Food additives in standardized foods. 170.210 How to send your GRAS notice to 170.15 Adoption of regulation on initiative FDA. of Commissioner. 170.215 Incorporation into a GRAS notice. 170.17 Exemption for investigational use 170.220 General requirements applicable to a and procedure for obtaining authoriza- GRAS notice. tion to market edible products from ex- 170.225 Part 1 of a GRAS notice: Signed perimental animals. statements and certification. 170.18 Tolerances for related food additives. 170.230 Part 2 of a GRAS notice: Identity, 170.19 Pesticide chemicals in processed method of manufacture, specifications, foods. and physical or technical effect. Subpart B—Food Additive Safety 170.235 Part 3 of a GRAS notice: Dietary exposure. 170.20 General principles for evaluating the 170.240 Part 4 of a GRAS notice: Self-lim- safety of food additives. iting levels of use. 170.22 Safety factors to be considered. 170.245 Part 5 of a GRAS notice: Experience 170.30 Eligibility for classification as gen- based on common use in food before 1958. erally recognized as safe (GRAS). 170.250 Part 6 of a GRAS notice: Narrative. 170.35 Affirmation of generally recognized 170.255 Part 7 of a GRAS notice: List of sup- as safe (GRAS) status. porting data and information in your 170.38 Determination of food additive sta- GRAS notice. tus. 170.260 Steps you may take before FDA re- 170.39 Threshold of regulation for sub- sponds to your GRAS notice. stances used in food-contact articles. 170.265 What FDA will do with a GRAS notice. Subpart C—Specific Administrative Rulings 170.270 Procedures that apply when the in- and Decisions tended conditions of use of a notified substance include use in a product or 170.45 Fluorine-containing compounds. products subject to regulation by the 170.50 Glycine (aminoacetic acid) in food for Food Safety and Inspection Service human consumption. (FSIS) of the United States Department 170.60 Nitrites and/or nitrates in curing pre- of Agriculture. mixes. 170.275 Public disclosure of a GRAS notice. 170.280 Submission of a supplement. Subpart D—Premarket Notifications 170.285 Disposition of pending GRAS affirmation petitions. 170.100 Submission of a premarket notification for a food contact substance (FCN) AUTHORITY: 21 U.S.C. 321, 341, 342, 346a, 348, to the Food and Drug Administration 371. (FDA). SOURCE: 42 FR 14483, Mar. 15, 1977, unless 170.101 Information in a premarket notifica- otherwise noted. tion for a food contact substance (FCN). 170.102 Confidentiality of information in a EDITORIAL NOTE: Nomenclature changes to premarket notification for a food contact part 170 appear at 66 FR 56035, Nov. 6, 2001, substance (FCN). and 69 FR 13717, Mar. 24, 2004. 170.103 Withdrawal without prejudice of a premarket notification for a food contact Subpart A—General Provisions substance (FCN). 170.104 Action on a premarket notification § 170.3 Definitions. for a food contact substance (FCN). 170.105 The Food and Drug Administration’s For the purposes of this subchapter, (FDA’s) determination that a premarket the following definitions apply: notification for a food contact substance (a) Secretary means the Secretary of (FCN) is no longer effective. Health and Human Services.

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(b) Department means the Department substance for food use by a significant of Health and Human Services. number of consumers. (c) Commissioner means the Commis- (g) The word substance in the defini- sioner of Food and Drugs. tion of the term ‘‘food additive’’ in- (d) As used in this part, the term act cludes a food or food component con- means the Federal Food, Drug, and sisting of one or more ingredients. Cosmetic Act approved June 25, 1936, 52 (h) Scientific procedures include the Stat. 1040 et seq., as amended (21 U.S.C. application of scientific data (includ- 301–392). ing, as appropriate, data from human, (e)(1) Food additives includes all sub- animal, analytical, or other scientific stances not exempted by section 201(s) studies), information, and methods, of the act, the intended use of which whether published or unpublished, as results or may reasonably be expected well as the application of scientific to result, directly or indirectly, either principles, appropriate to establish the in their becoming a component of food or otherwise affecting the characteris- safety of a substance under the condi- tics of food. A material used in the pro- tions of its intended use. duction of containers and packages is (i) Safe or safety means that there is subject to the definition if it may rea- a reasonable certainty in the minds of sonably be expected to become a com- competent scientists that the sub- ponent, or to affect the characteristics, stance is not harmful under the condi- directly or indirectly, of food packed in tions of its intended use. It is impos- the container. ‘‘Affecting the charac- sible in the present state of scientific teristics of food’’ does not include such knowledge to establish with complete physical effects, as protecting contents certainty the absolute harmlessness of of packages, preserving shape, and pre- the use of any substance. Safety may venting moisture loss. If there is no be determined by scientific procedures migration of a packaging component or by general recognition of safety. In from the package to the food, it does determining safety, the following fac- not become a component of the food tors shall be considered: and thus is not a food additive. A sub- (1) The probable consumption of the stance that does not become a compo- substance and of any substance formed nent of food, but that is used, for exam- in or on food because of its use. ple, in preparing an ingredient of the (2) The cumulative effect of the sub- food to give a different flavor, texture, stance in the diet, taking into account or other characteristic in the food, any chemically or pharmacologically may be a food additive. related substance or substances in such (2) Uses of food additives not requiring diet. a listing regulation. Use of a substance (3) Safety factors which, in the opin- in a food contact article (e.g., food- ion of experts qualified by scientific packaging or food-processing equip- training and experience to evaluate the ment) whereby the substance migrates, safety of food and food ingredients, are or may reasonably be expected to mi- generally recognized as appropriate. grate, into food at such levels that the use has been exempted from regulation (j) The term nonperishable processed as a food additive under § 170.39, and food means any processed food not sub- food contact substances used in accord- ject to rapid decay or deterioration ance with a notification submitted that would render it unfit for consump- under section 409(h) of the act that is tion. Examples are flour, sugar, cere- effective. als, packaged cookies, and crackers. (3) A food contact substance is any sub- Not included are hermetically sealed stance that is intended for use as a foods or manufactured dairy products component of materials used in manu- and other processed foods requiring re- facturing, packing, packaging, trans- frigeration. porting, or holding food if such use is (k) General recognition of safety shall not intended to have any technical ef- be in accordance with § 170.30. fect in such food. (l) Prior sanction means an explicit (f) Common use in food means a sub- approval granted with respect to use of stantial history of consumption of a a substance in food prior to September

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6, 1958, by the Food and Drug Adminis- (8) Condiments and relishes, includ- tration or the United States Depart- ing plain seasoning sauces and spreads, ment of Agriculture pursuant to the olives, pickles, and relishes, but not Federal Food, Drug, and Cosmetic Act, spices or herbs. the Poultry Products Inspection Act, (9) Confections and frostings, includ- or the Meat Inspection Act. ing candy and flavored frostings, (m) Food includes human food, sub- marshmallows, baking chocolate, and stances migrating to food from food- brown, lump, rock, maple, powdered, contact articles, pet food, and animal and raw sugars. feed. (10) Dairy product analogs, including (n) The following general food cat- nondairy milk, frozen or liquid cream- egories are established to group spe- ers, coffee whiteners, toppings, and cific related foods together for the pur- other nondairy products. pose of establishing tolerances or limi- (11) Egg products, including liquid, tations for the use of direct human frozen, or dried eggs, and egg dishes food ingredients. Individual food prod- made therefrom, i.e., egg roll, egg foo ucts will be included within these cat- young, egg salad, and frozen multi- egories according to the detailed clas- course egg meals, but not fresh eggs. sifications lists contained in Exhibit (12) Fats and oils, including mar- 33B of the report of the National Acad- garine, dressings for salads, butter, emy of Sciences/National Research salad oils, shortenings and cooking Council report, ‘‘A Comprehensive Sur- oils. vey of Industry on the Use of Food (13) Fish products, including all pre- Chemicals Generally Recognized as pared main dishes, salads, appetizers, Safe’’ (September 1972), which is incor- frozen multicourse meals, and spreads porated by reference. Copies are avail- containing fish, shellfish, and other able from the National Technical Infor- aquatic animals, but not fresh fish. mation Service (NTIS), 5285 Port Royal (14) Fresh eggs, including cooked Rd., Springfield, VA 22161, or at the Na- eggs and egg dishes made only from tional Archives and Records Adminis- fresh shell eggs. tration (NARA). For information on (15) Fresh fish, including only fresh the availability of this material at and frozen fish, shellfish, and other NARA, call 202–741–6030, or go to: http:// aquatic animals. www.archives.gov/federallregister/ (16) Fresh fruits and fruit juices, in- codeloflfederallregulations/ cluding only raw fruits, citrus, melons, ibrllocations.html. and berries, and home-prepared ‘‘ades’’ and punches made therefrom. (1) Baked goods and baking mixes, in- (17) Fresh meats, including only fresh cluding all ready-to-eat and ready-to- or home-frozen beef or veal, pork, lamb bake products, flours, and mixes re- or mutton and home-prepared fresh quiring preparation before serving. meat-containing dishes, salads, appe- (2) Beverages, alcoholic, including tizers, or sandwich spreads made there- malt beverages, wines, distilled liq- from. uors, and cocktail mix. (18) Fresh poultry, including only (3) Beverages and beverage bases, fresh or home-frozen poultry and game nonalcoholic, including only special or birds and home-prepared fresh poultry- spiced teas, soft drinks, coffee sub- containing dishes, salads, appetizers, or stitutes, and fruit and vegetable fla- sandwich spreads made therefrom. vored gelatin drinks. (19) Fresh vegetables, tomatoes, and (4) Breakfast cereals, including potatoes, including only fresh and ready-to-eat and instant and regular home-prepared vegetables. hot cereals. (20) Frozen dairy desserts and mixes, (5) Cheeses, including curd and whey including ice cream, ice milks, sher- cheeses, cream, natural, grating, proc- bets, and other frozen dairy desserts essed, spread, dip, and miscellaneous and specialties. cheeses. (21) Fruit and water ices, including (6) Chewing gum, including all forms. all frozen fruit and water ices. (7) Coffee and tea, including regular, (22) Gelatins, puddings, and fillings, decaffeinated, and instant types. including flavored gelatin desserts,

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puddings, custards, parfaits, pie fill- centrates, dilutions, ‘‘ades’’, and drink ings, and gelatin base salads. substitutes made therefrom. (23) Grain products and pastas, in- (36) Processed vegetables and vege- cluding macaroni and noodle products, table juices, including all commer- rice dishes, and frozen multicourse cially processed vegetables, vegetable meals, without meat or vegetables. dishes, frozen multicourse vegetable (24) Gravies and sauces, including all meals, and vegetable juices and blends. meat sauces and gravies, and tomato, (37) Snack foods, including chips, milk, buttery, and specialty sauces. pretzels, and other novelty snacks. (25) Hard candy and cough drops, in- (38) Soft candy, including candy bars, cluding all hard type candies. chocolates, fudge, mints, and other (26) Herbs, seeds, spices, seasonings, chewy or nougat candies. blends, extracts, and flavorings, includ- (39) Soups, home-prepared, including ing all natural and artificial spices, meat, fish, poultry, vegetable, and blends, and flavors. combination home-prepared soups. (27) Jams and jellies, home-prepared, (40) Soups and soup mixes, including including only home-prepared jams, commercially prepared meat, fish, jellies, fruit butters, preserves, and poultry, vegetable, and combination sweet spreads. soups and soup mixes. (28) Jams and jellies, commercial, in- (41) Sugar, white, granulated, includ- cluding only commercially processed ing only white granulated sugar. jams, jellies, fruit butters, preserves, (42) Sugar substitutes, including and sweet spreads. granulated, liquid, and tablet sugar (29) Meat products, including all substitutes. meats and meat containing dishes, sal- (43) Sweet sauces, toppings, and syr- ads, appetizers, frozen multicourse ups, including chocolate, berry, fruit, meat meals, and sandwich ingredients corn syrup, and maple sweet sauces and prepared by commercial processing or toppings. using commercially processed meats (o) The following terms describe the with home preparation. physical or technical functional effects (30) Milk, whole and skim, including for which direct human food ingredi- only whole, lowfat, and skim fluid ents may be added to foods. They are milks. adopted from the National Academy of (31) Milk products, including flavored Sciences/National Research Council na- milks and milk drinks, dry milks, top- tional survey of food industries, re- pings, snack dips, spreads, weight con- ported to the Food and Drug Adminis- trol milk beverages, and other milk or- tration under the contract title ‘‘A igin products. Comprehensive Survey of Industry on (32) Nuts and nut products, including the Use of Food Chemicals Generally whole or shelled tree nuts, peanuts, co- Recognized as Safe’’ (September 1972), conut, and nut and peanut spreads. which is incorporated by reference. (33) Plant protein products, including Copies are available from the National the National Academy of Sciences/Na- Technical Information Service (NTIS), tional Research Council ‘‘reconstituted 5285 Port Royal Rd., Springfield, VA vegetable protein’’ category, and meat, 22161, or at the National Archives and poultry, and fish substitutes, analogs, Records Administration (NARA). For and extender products made from plant information on the availability of this proteins. material at NARA, call 202–741–6030, or (34) Poultry products, including all go to: http://www.archives.gov/ poultry and poultry-containing dishes, federallregister/ salads, appetizers, frozen multicourse codeloflfederallregulations/ poultry meals, and sandwich ingredi- ibrllocations.html. ents prepared by commercial proc- (1) Anticaking agents and free-flow essing or using commercially processed agents: Substances added to finely pow- poultry with home preparation. dered or crystalline food products to (35) Processed fruits and fruit juices, prevent caking, lumping, or agglomer- including all commercially processed ation. fruits, citrus, berries, and mixtures; (2) Antimicrobial agents: Substances salads, juices and juice punches, con- used to preserve food by preventing

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growth of microorganisms and subse- carriers, binders, fillers, plasticizers, quent spoilage, including fungistats, film-formers, and tableting aids, etc. mold and rope inhibitors, and the ef- (15) Fumigants: Volatile substances fects listed by the National Academy of used for controlling insects or pests. Sciences/National Research Council (16) Humectants: Hygroscopic sub- under ‘‘preservatives.’’ stances incorporated in food to pro- (3) Antioxidants: Substances used to mote retention of moisture, including preserve food by retarding deteriora- moisture-retention agents and anti- tion, rancidity, or discoloration due to dusting agents. oxidation. (17) Leavening agents: Substances (4) Colors and coloring adjuncts: Sub- used to produce or stimulate produc- stances used to impart, preserve, or en- tion of carbon dioxide in baked goods hance the color or shading of a food, in- to impart a light texture, including cluding color stabilizers, color fixa- yeast, yeast foods, and calcium salts tives, color-retention agents, etc. listed by the National Academy of (5) Curing and pickling agents: Sub- Sciences/National Research Council stances imparting a unique flavor and/ under ‘‘dough conditioners.’’ or color to a food, usually producing an (18) Lubricants and release agents: Sub- increase in shelf life stability. stances added to food contact surfaces (6) Dough strengtheners: Substances to prevent ingredients and finished used to modify starch and gluten, products from sticking to them. thereby producing a more stable dough, (19) Non-nutritive sweeteners: Sub- including the applicable effects listed stances having less than 2 percent of by the National Academy of Sciences/ the caloric value of sucrose per equiva- National Research Council under lent unit of sweetening capacity. ‘‘dough conditioner.’’ (20) Nutrient supplements: Substances (7) Drying agents: Substances with which are necessary for the body’s nu- moisture-absorbing ability, used to tritional and metabolic processes. maintain an environment of low mois- (21) Nutritive sweeteners: Substances ture. having greater than 2 percent of the ca- (8) Emulsifiers and emulsifier salts: loric value of sucrose per equivalent Substances which modify surface ten- unit of sweetening capacity. sion in the component phase of an (22) Oxidizing and reducing agents: emulsion to establish a uniform disper- Substances which chemically oxidize sion or emulsion. or reduce another food ingredient, (9) Enzymes: Enzymes used to im- thereby producing a more stable prod- prove food processing and the quality uct, including the applicable effect list- of the finished food. ed by the National Academy of (10) Firming agents: Substances added Sciences/National Research Council to precipitate residual pectin, thus under ‘‘dough conditioners.’’ strengthening the supporting tissue (23) pH control agents: Substances and preventing its collapse during added to change or maintain active processing. acidity or basicity, including buffers, (11) Flavor enhancers: Substances acids, alkalies, and neutralizing added to supplement, enhance, or mod- agents. ify the original taste and/or aroma of a (24) Processing aids: Substances used food, without imparting a char- as manufacturing aids to enhance the acteristic taste or aroma of its own. appeal or utility of a food or food com- (12) Flavoring agents and adjuvants: ponent, including clarifying agents, Substances added to impart or help im- clouding agents, catalysts, flocculents, part a taste or aroma in food. filter aids, and crystallization inhibi- (13) Flour treating agents: Substances tors, etc. added to milled flour, at the mill, to (25) Propellants, aerating agents, and improve its color and/or baking quali- gases: Gases used to supply force to ties, including bleaching and maturing expel a product or used to reduce the agents. amount of oxygen in contact with the (14) Formulation aids: Substances used food in packaging. to promote or produce a desired phys- (26) Sequestrants: Substances which ical state or texture in food, including combine with polyvalent metal ions to

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form a soluble metal complex, to im- (b) Since enactment of the Food Ad- prove the quality and stability of prod- ditives Amendment, the Food and Drug ucts. Administration has advised such in- (27) Solvents and vehicles: Substances quirers that an article: used to extract or dissolve another sub- (1) Is a food additive within the stance. meaning of section 201(s) of the act; or (28) Stabilizers and thickeners: Sub- (2) Is generally recognized as safe stances used to produce viscous solu- (GRAS); or tions 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: Substances health, such articles which have been used to modify surface properties of considered in the past by the Food and liquid food components for a variety of Drug Administration to be safe under effects, other than emulsifiers, but in- the provisions of section 402(a)(1), or to cluding 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 ping agents, foaming agents, and de- additives under the conditions of in- foaming agents, etc. tended use, must be reexamined in the (30) Surface-finishing agents: Sub- light of current scientific information stances used to increase palatability, and current principles for evaluating preserve gloss, and inhibit discolora- the safety of food additives if their use tion of foods, including glazes, polishes, is to be continued. waxes, and protective coatings. (d) Because of the time span in- (31) Synergists: Substances used to act volved, copies of many of the letters in or react with another food ingredient which the Food and Drug Administra- to produce a total effect different or tion has expressed an informal opinion greater than the sum of the effects pro- concerning the status of such articles duced by the individual ingredients. may no longer be in the file of the Food (32) Texturizers: Substances which af- and Drug Administration. In the ab- fect the appearance or feel of the food. sence of information concerning the names and uses made of all the articles [42 FR 14483, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19, 1982; 53 FR 16546, May 10, referred to in such letters, their safety 1988; 54 FR 24896, June 12, 1989; 60 FR 36595, of use cannot be reexamined. For this July 17, 1995; 67 FR 35729, May 21, 2002; 81 FR reason all food additive status opinions 55047, Aug. 17, 2016] of the kind described in paragraph (c) of this section given by the Food and § 170.6 Opinion letters on food addi- Drug Administration are hereby re- tive status. voked. (a) Over the years the Food and Drug (e) The prior opinions of the kind de- Administration has given informal scribed in paragraph (c) of this section written opinions to inquiries as to the will be replaced by qualified and cur- safety of articles intended for use as rent opinions if the recipient of each components of, or in contact with, such letter forwards a copy of each to food. Prior to the enactment of the the Department of Health and Human Food Additives Amendment of 1958 Services, Food and Drug Administra- (Pub. L. 85–929; Sept. 6, 1958), these tion, Center for Food Safety and Ap- opinions were given pursuant to sec- plied Nutrition, 5001 Campus Dr., Col- tion 402(a)(1) of the Federal Food, lege Park, MD 20740, along with a copy Drug, and Cosmetic Act, which reads in of his letter of inquiry, on or before part: ‘‘A food shall be deemed to be July 23, 1970. adulterated if it bears or contains any (f) This section does not apply to food poisonous or deleterious substance additive status opinion letters per- which may render it injurious to taining to articles that were considered health’’. by the Food and Drug Administration

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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. [42 FR 14483, Mar. 15, 1977, as amended at 54 § 170.15 Adoption of regulation on ini- FR 24896, June 12, 1989; 81 FR 49896, July 29, tiative of Commissioner. 2016] (a) The Commissioner upon his own initiative may propose the issuance of § 170.10 Food additives in standard- a regulation prescribing, with respect ized foods. 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. (b) Action upon a proposal made by Where a petition is received for the the Commissioner shall proceed as pro- issuance or amendment of a regulation vided in part 10 of this chapter. establishing a definition and standard 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] sion of a food additive in such definition and standard of identity, the pro- § 170.17 Exemption for investigational visions of the regulations in this part use and procedure for obtaining au- shall apply with respect to the infor- thorization to market edible products from experimental animals. mation that must be submitted with respect to the food additive. Since sec- A food additive or food containing a tion 409(b)(5) of the Act requires that food additive intended for investiga- the Secretary publish notice of a peti- tional use by qualified experts shall be tion for the establishment of a food-ad- exempt from the requirements of sec- ditive regulation within 30 days after tion 409 of the Act under the following filing, notice of a petition relating to a conditions: definition and standard of identity (a) If intended for investigational use shall also be published within that in vitro or in laboratory research ani- time limitation if it includes a request, mals, it bears a label which states so designated, for the establishment of prominently, in addition to the other a regulation pertaining to a food addi- information required by the act, the tive. warning: (b) If a petition for a definition and standard of identity contains a pro- Caution. Contains a new food additive for investigational use only in laboratory re- posal for a food-additive regulation, search animals or for tests in vitro. Not for and the petitioner fails to designate it use in humans. as such, the Commissioner, upon determining that the petition includes a (b) If intended for use in animals proposal for a food-additive regulation, other than laboratory research animals shall so notify the petitioner and shall and if the edible products of the ani- thereafter proceed in accordance with mals are to be marketed as food, per- the regulations in this part. mission for the marketing of the edible (c) A regulation will not be issued al- products as food has been requested by lowing the use of a food additive in a the sponsor, and authorization has food for which a definition and stand- been granted by the Food and Drug Ad- ard of identity is established, unless its ministration in accordance with § 511.1 issuance is in conformity with section of this chapter or by the Department of 401 of the Act or with the terms of a Agriculture in accordance with 9 CFR temporary permit issued under § 130.17 309.17, and it bears a label which states of this chapter. When the contemplated prominently, in addition to the other use of such additive complies with the information required by the Act, the terms of a temporary permit, the food warning:

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Caution. Contains a new food additive for (2) Divide the quantity of each res- use only in investigational animals. Not for idue by the tolerance that would apply use in humans. if it occurred alone, and multiply by Edible products of investigational animals 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 with the regulations set forth in part 58 § 170.19 Pesticide chemicals in proc- of this chapter. essed foods. [42 FR 14483, Mar. 15, 1977, as amended at 43 When pesticide chemical residues FR 60021, Dec. 22, 1978] occur in processed foods due to the use of raw agricultural commodities that § 170.18 Tolerances for related food ad- bore or contained a pesticide chemical ditives. in conformity with an exemption (a) Food additives that cause similar granted or a tolerance prescribed under or related pharmacological effects will section 408 of the Act, the processed be regarded as a class, and in the ab- food will not be regarded as adulter- sence of evidence to the contrary, as ated so long as good manufacturing having additive toxic effects and will practice has been followed in removing be considered as related food additives. any residue from the raw agricultural (b) Tolerances established for such commodity in the processing (such as related food additives may limit the by peeling or washing) and so long as amount of a common component that the concentration of the residue in the may be present, or may limit the processed food when ready to eat is not amount of biological activity (such as greater than the tolerance prescribed cholinesterase inhibition) that may be for the raw agricultural commodity. present or may limit the total amount But when the concentration of residue of related food additives that may be in the processed food when ready to eat present. is higher than the tolerance prescribed (c) Where food additives from two or more chemicals in the same class are for the raw agricultural commodity, present in or on a food, the tolerance the processed food is adulterated unless for the total of such additives shall be the higher concentration is permitted the same as that for the additive hav- by a tolerance obtained under section ing the lowest numerical tolerance in 409 of the Act. For example, if fruit this class, unless there are available bearing a residue of 7 parts per million methods that permit quantitative de- of DDT permitted on the raw agricul- termination of the amount of each food tural commodity is dried and a residue additive present or unless it is shown in excess of 7 parts per million of DDT that a higher tolerance is reasonably results on the dried fruit, the dehy- required for the combined additives to drated fruit is adulterated unless the accomplish the physical or technical higher tolerance for DDT is authorized effect for which such combined addi- by the regulations in this part. Food tives are intended and that the higher that is itself ready to eat, and which tolerance will be safe. contains a higher residue than allowed (d) Where residues from two or more for the raw agricultural commodity, additives in the same class are present may not be legalized by blending or in or on a food and there are available mixing with other foods to reduce the methods that permit quantitative de- residue in the mixed food below the tol- termination of each residue, the quan- erance prescribed for the raw agricul- tity of combined residues that are tural commodity. within the tolerance may be determined as follows: (1) Determine the quantity of each residue present.

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Subpart B—Food Additive Safety tation data to man of 100 to 1, will be used; that is, a food additive for use by § 170.20 General principles for evalu- man will not be granted a tolerance ating the safety of food additives. that will exceed 1⁄100th of the maximum (a) In reaching a decision on any pe- amount demonstrated to be without tition filed under section 409 of the harm to experimental animals. Act, the Commissioner will give full consideration to the specific biological § 170.30 Eligibility for classification as properties of the compound and the generally recognized as safe adequacy of the methods employed to (GRAS). demonstrate safety for the proposed (a) General recognition of safety may use, and the Commissioner will be be based only on the views of experts guided by the principles and procedures qualified by scientific training and ex- for establishing the safety of food addi- perience to evaluate the safety of sub- tives stated in current publications of stances directly or indirectly added to the National Academy of Sciences-Na- food. The basis of such views may be ei- tional Research Council. A petition ther (1) scientific procedures or (2) in will not be denied, however, by reason the case of a substance used in food of the petitioner’s having followed pro- prior to January 1, 1958, through expe- cedures other than those outlined in rience based on common use in food. the publications of the National Acad- General recognition of safety requires emy of Sciences-National Research common knowledge throughout the sci- Council if, from available evidence, the entific community knowledgeable Commissioner finds that the proce- about the safety of substances directly dures used give results as reliable as, or indirectly added to food that there or more reliable than, those reasonably is reasonable certainty that the sub- to be expected from the use of the out- stance is not harmful under the condi- lined procedures. In reaching a deci- tions of its intended use (see § 170.3(i)). sion, the Commissioner will give due (b) General recognition of safety weight to the anticipated levels and based upon scientific procedures shall patterns of consumption of the additive specified or reasonably inferrable. For require the same quantity and quality the purposes of this section, the prin- of scientific evidence as is required to ciples for evaluating safety of additives obtain approval of a food additive. Gen- set forth in the abovementioned publi- eral recognition of safety through sci- cations will apply to any substance entific procedures shall be based upon that may properly be classified as a the application of generally available food additive as defined in section and accepted scientific data, informa- 201(s) of the Act. tion, or methods, which ordinarily are (b) Upon written request describing published, as well as the application of the proposed use of an additive and the scientific principles, and may be cor- proposed experiments to determine its roborated by the application of unpub- safety, the Commissioner will advise a lished scientific data, information, or person who wishes to establish the methods. safety of a food additive whether he be- (c)(1) General recognition of safety lieves the experiments planned will through experience based on common yield data adequate for an evaluation use in food prior to January 1, 1958, of the safety of the additive. may be achieved without the quantity or quality of scientific procedures re- § 170.22 Safety factors to be consid- quired for approval of a food additive. ered. General recognition of safety through In accordance with section experience based on common use in 409(c)(5)(C) of the Act, the following food prior to January 1, 1958, shall be safety factors will be applied in deter- based solely on food use of the sub- mining whether the proposed use of a stance prior to January 1, 1958, and food additive will be safe: Except where shall ordinarily be based upon gen- evidence is submitted which justifies erally available data and information. use of a different safety factor, a safety An ingredient not in common use in factor in applying animal experimen- food prior to January 1, 1958, may

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achieve general recognition of safety GRAS without specific inclusion in only through scientific procedures. part 182, part 184 or part 186 of this (2) A substance used in food prior to chapter. January 1, 1958, may be generally rec- (e) Food ingredients were listed as ognized as safe through experience GRAS in part 182 of this chapter during based on its common use in food when 1958–1962 without a detailed scientific that use occurred exclusively or pri- review of all available data and infor- marily outside of the United States if mation relating to their safety. Begin- the information about the experience ning in 1969, the Food and Drug Admin- establishes that the substance is safe istration has undertaken a systematic under the conditions of its intended use review of the status of all ingredients within the meaning of section 201(u) of used in food based on the view that the Federal Food, Drug, and Cosmetic they are GRAS under the conditions of Act (see also § 170.3(i)). Common use in their intended use or subject to a prior food prior to January 1, 1958, that oc- sanction. All affirmations of GRAS sta- curred outside of the United States tus or determinations of food additive shall be documented by published or status or prior sanction status pursu- other information and shall be corrobo- ant to this review shall be handled pur- rated by information from a second, suant to §§ 170.35, 170.38, and 180.1 of independent source that confirms the this chapter. Affirmation of GRAS sta- history and circumstances of use of the tus shall be announced in part 184 or substance. The information used to part 186 of this chapter. document and to corroborate the his- (f) [Reserved] tory and circumstances of use of the (h) A food ingredient that is listed as substance must be generally available; GRAS in part 182 of this chapter or af- that is, it must be widely available in firmed as GRAS in part 184 or part 186 the country in which the history of use of this chapter shall be regarded as has occurred and readily available to GRAS only if, in addition to all the re- interested qualified experts in the quirements in the applicable regula- United States. A person who concludes that a use of a substance is GRAS tion, it also meets all of the following through experience based on its com- requirements: mon use in food outside of the United (1) It complies with any applicable States should notify FDA of that view food grade specifications of the Food in accordance with subpart E of this Chemicals Codex, 2d Ed. (1972), or, if part. specifically indicated in the GRAS af- (d) The food ingredients listed as firmation regulation, the Food Chemi- GRAS in part 182 of this chapter or af- cals Codex, 3d Ed. (1981), which are in- firmed as GRAS in part 184 or part 186 corporated by reference, except that of this chapter do not include all sub- any substance used as a component of stances that are generally recognized articles that contact food and affirmed as safe for their intended use in food. as GRAS in part 186 of this chapter Because of the large number of sub- shall comply with the specifications stances the intended use of which re- therein, or in the absence of such speci- sults or may reasonably be expected to fications, shall be of a purity suitable result, directly or indirectly, in their for its intended use. Copies may be ob- becoming a component or otherwise af- tained from the National Academy fecting the characteristics of food, it is Press, 2101 Constitution Ave. NW., impracticable to list all such sub- Washington, DC 20418, or at the Na- stances that are GRAS. A food ingre- tional Archives and Records Adminis- dient of natural biological origin that tration (NARA). For information on has been widely consumed for its nutri- the availability of this material at ent properties in the United States NARA, call 202–741–6030, or go to: http:// prior to January 1, 1958, without known www.archives.gov/federallregister/ detrimental effects, which is subject codeloflfederallregulations/ only to conventional processing as ibrllocations.html. practiced prior to January 1, 1958, and (2) It performs an appropriate func- for which no known safety hazard ex- tion in the food or food-contact article ists, will ordinarily be regarded as in which it is used.

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(3) It is used at a level no higher than § 170.35 Affirmation of generally recog- necessary to achieve its intended pur- nized as safe (GRAS) status. pose in that food or, if used as a compo- (a) The Commissioner, on his own nent of a food-contact article, at a initiative, may affirm that a substance level no higher than necessary to that directly or indirectly becomes a achieve its intended purpose in that ar- component of food is GRAS under the ticle. conditions of its intended use. (i) If a substance is affirmed as GRAS (b)(1) If the Commissioner proposes in part 184 or part 186 of this chapter on his own initiative that a substance with no limitation other than good is entitled to affirmation as GRAS manufacturing practice, it shall be re- under the conditions of its intended garded as GRAS if its conditions of use use, he will place all of the data and in- are not significantly different from formation on which he relies on public those reported in the regulation as the file in the office of the Division of basis on which the GRAS status of the Dockets Management and will publish substance was affirmed. If the condi- in the FEDERAL REGISTER a notice giv- tions of use are significantly different, ing the name of the substance, its pro- such use of the substance may not be posed uses, and any limitations pro- GRAS. In such a case a manufacturer posed for purposes other than safety. may not rely on the regulation as au- (2) The FEDERAL REGISTER notice will thorizing the use but must independ- allow a period of 60 days during which ently establish that the use is GRAS or any interested person may review the must use the substance in accordance data and information and/or file com- with a food additive regulation. ments with the Division of Dockets (j) If an ingredient is affirmed as Management. Copies of all comments GRAS in part 184 or part 186 of this received shall be made available for ex- chapter with specific limitation(s), it amination in the Division of Dockets may be used in food only within such Management’s office. limitation(s) (including the category of (3) The Commissioner will evaluate food(s), the functional use(s) of the in- all comments received. If he concludes gredient, and the level(s) of use). Any that there is convincing evidence that use of such an ingredient not in full the substance is GRAS under the con- compliance with each such established ditions of its intended use as described limitation shall require a food additive in § 170.30, he will publish a notice in regulation. the FEDERAL REGISTER listing the (k) Pursuant to § 170.35, a food ingre- GRAS conditions of use of the sub- dient may be affirmed as GRAS in part stance in part 184 or part 186 of this 184 or part 186 of this chapter for a spe- chapter, as appropriate. cific use(s) without a general evalua- (4) If, after evaluation of the com- tion of use of the ingredient. In addi- ments, the Commissioner concludes tion to the use(s) specified in the regu- that there is a lack of convincing evi- lation, other uses of such an ingredient dence that a substance is GRAS under may also be GRAS. Any affirmation of the conditions of its intended use and GRAS status for a specific use(s), with- that it should be considered a food ad- out a general evaluation of use of the ditive subject to section 409 of the Fed- ingredient, is subject to reconsider- eral Food, Drug, and Cosmetic Act, he ation upon such evaluation. shall publish a notice thereof in the (l) New information may at any time FEDERAL REGISTER in accordance with require reconsideration of the GRAS § 170.38. status of a food ingredient. Any change to the GRAS status of a food ingre- (Information collection requirements were approved by the Office of Management and dient in parts 182, 184, or 186 of this Budget under control number 0910–0132) chapter shall be accomplished pursuant to § 170.38. [42 FR 14488, Mar. 15, 1977, as amended at 50 FR 7492, Feb. 22, 1985; 50 FR 16668, Apr. 26, [42 FR 14483, Mar. 15, 1977, as amended at 49 1985; 53 FR 16547, May 10, 1988; 62 FR 40599, FR 5610, Feb. 14, 1984; 53 FR 16546, May 10, July 29, 1997; 65 FR 51762, Aug. 25, 2000; 81 FR 1988; 81 FR 55047, Aug. 17, 2016] 55048, Aug. 17, 2016]

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§ 170.38 Determination of food addi- (2) It may promulgate an interim tive status. food additive regulation governing use (a) The Commissioner may, in ac- of the additive. cordance with § 170.35(b)(4), publish a (3) It may require discontinuation of notice in the FEDERAL REGISTER deter- the use of the additive. mining that a substance is not GRAS (4) It may adopt any combination of under the conditions of its intended use the above three approaches for dif- and is a food additive subject to section ferent uses or levels of use of the addi- 409 of the Federal Food, Drug, and Cos- tive. metic Act. (d) If the Commissioner of Food and (b)(1) The Commissioner, on his own Drugs is aware of any prior sanction initiative or on the petition of any infor use of the substance, he will con- terested person, pursuant to part 10 of currently propose a separate regulation this chapter, may issue a notice in the covering such use of the ingredient FEDERAL REGISTER proposing to deter- under part 181 of this chapter. If the mine that a substance is not GRAS and Commissioner is unaware of any such is a food additive subject to section 409 applicable prior sanction, the proposed of the Act. Any petition shall include regulation will so state and will re- all relevant data and information of quire any person who intends to assert the type described in § 171.130(b). The or rely on such sanction to submit Commissioner will place all of the data proof of its existence. Any regulation and information on which he relies on promulgated pursuant to this section public file in the office of the Division constitutes a determination that ex- of Dockets Management and will included uses would result in adultera- clude in the FEDERAL REGISTER notice tion of the food in violation of section the name of the substance, its known 402 of the Act, and the failure of any uses, and a summary of the basis for person to come forward with proof of the determination. such an applicable prior sanction in re- (2) The FEDERAL REGISTER notice will sponse to the proposal will constitute a allow a period of 60 days during which waiver of the right to assert or rely on any interested person may review the such sanction at any later time. The data and information and/or file com- notice will also constitute a proposal ments with the Division of Dockets to establish a regulation under part 181 Management. Copies of all comments of this chapter, incorporating the same shall be made available for examina- provisions, in the event that such a tion in the Division of Dockets Man- regulation is determined to be appro- agement’s office. priate as a result of submission of proof (3) The Commissioner will evaluate of such an applicable prior sanction in all comments received. If he concludes response to the proposal. that there is a lack of convincing evidence that the substance is GRAS or is [42 FR 14488, Mar. 15, 1977, as amended at 42 otherwise exempt from the definition FR 15673, Mar. 22, 1977; 54 FR 24896, June 12, of a food additive in section 201(s) of 1989; 81 FR 55048, Aug. 17, 2016] the Act, he will publish a notice thereof in the FEDERAL REGISTER. If he con- § 170.39 Threshold of regulation for cludes that there is convincing evi- substances used in food-contact articles. dence that the substance is GRAS, he will publish an order in the FEDERAL (a) A substance used in a food-con- REGISTER listing the substance as tact article (e.g., food-packaging or GRAS in part 182, part 184, or part 186 food-processing equipment) that mi- of this chapter, as appropriate. grates, or that may be expected to mi- (c) A FEDERAL REGISTER notice deter- grate, into food will be exempted from mining that a substance is a food addi- regulation as a food additive because it tive shall provide for the use of the ad- becomes a component of food at levels ditive in food or food contact surfaces that are below the threshold of regula- as follows: tion if: (1) It may promulgate a food additive (1) The substance has not been shown regulation governing use of the addi- to be a carcinogen in humans or ani- tive. mals, and there is no reason, based on

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the chemical structure of the sub- substance from regulation as a food ad- stance, to suspect that the substance is ditive shall include three copies of the a carcinogen. The substance must also following information (If part of the not contain a carcinogenic impurity or, submitted material is in a foreign lan- if it does, must not contain a carcino- guage, it must be accompanied by an genic impurity with a TD50 value based English translation verified to be com- on chronic feeding studies reported in plete and accurate in accordance with the scientific literature or otherwise § 10.20(c)(2) of this chapter): available to the Food and Drug Admin- (1) The chemical composition of the istration of less than 6.25 milligrams substance for which the request is per kilogram bodyweight per day (The made, including, whenever possible, TD50, for the purposes of this section, is the name of the chemical in accord- the feeding dose that causes cancer in ance with current Chemical Abstract 50 percent of the test animals when Service (CAS) nomenclature guidelines corrected for tumors found in control and a CAS registry number, if avail- animals. If more than one TD50 value able; has been reported in the scientific lit- (2) Detailed information on the con- erature for a substance, the Food and ditions of use of the substance (e.g., Drug Administration will use the low- temperature, type of food with which est appropriate TD50 value in its re- the substance will come into contact, view.); the duration of the contact, and wheth- (2) The substance presents no other er the food-contact article will be for health or safety concerns because: repeated or single use applications); (i) The use in question has been (3) A clear statement as to whether shown to result in or may be expected the request for exemption from regula- to result in dietary concentrations at tion as a food additive is based on the or below 0.5 parts per billion, cor- fact that the use of the substance in responding to dietary exposure levels the food-contact article results in a di- at or below 1.5 micrograms/person/day etary concentration at or below 0.5 (based on a diet of 1,500 grams of solid parts per billion, or on the fact that it food and 1,500 grams of liquid food per involves the use of a regulated direct person per day); or food additive for which the dietary ex- (ii) The substance is currently regu- posure is at or below 1 percent of the lated for direct addition into food, and acceptable dietary intake (ADI); the dietary exposure to the substance (4) Data that will enable the Food resulting from the proposed use is at or and Drug Administration to estimate below 1 percent of the acceptable daily the daily dietary concentration result- intake as determined by safety data in ing from the proposed use of the sub- the Food and Drug Administration’s stance. These data should be in the files or from other appropriate sources; form of: (3) The substance has no technical ef- (i) Validated migration data obtained fect in or on the food to which it mi- under worst-case (time/temperature) grates; and intended use conditions utilizing ap- (4) The substance use has no signifi- propriate food simulating solvents; cant adverse impact on the environ- (ii) Information on the amount of the ment. substance used in the manufacture of (b) Notwithstanding paragraph (a) of the food-contact article; or this section, the Food and Drug Admin- (iii) Information on the residual level istration reserves the right to decline of the substance in the food-contact ar- to grant an exemption in those cases in ticle. For repeat-use articles, an esti- which available information estab- mate of the amount of food that con- lishes that the proposed use may pose a tacts a specific unit of surface area public health risk. The reasons for the over the lifetime of the article should agency’s decision to decline to grant an also be provided. (In cases where data exemption will be explained in the are provided only in the form of manu- Food and Drug Administration’s re- facturing use levels or residual levels sponse to the requestor. of the substance present in the food- (c) A request for the Food and Drug contact article, the Food and Drug Ad- Administration to exempt a use of a ministration will calculate a worst-

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case dietary concentration level as- Administration will maintain a list of suming 100 percent migration.) A de- substances exempted from regulation tailed description of the analytical as food additives under this section on method used to quantify the substance display at the Division of Dockets should also be submitted along with Management. This list will include the data used to validate the detection name of the company that made the re- limit. quest, the chemical name of the sub- (iv) In cases where there is no detect- stance, the specific use for which it has able migration into food or food received an exemption from regulation simulants, or when no residual level of as a food additive, and any appropriate a substance is detected in the food-con- limitations on its use. The list will not tact article by a suitable analytical include any trade names. This list will method, the Food and Drug Adminis- enable interested persons to see the tration will, for the purposes of esti- types of uses of food-contact materials mating the dietary concentration, con- being exempted under the regulation. sider the validated detection limit of Interested persons may also obtain a the method used to analyze for the sub- copy of the list of exempted substances stance. by contacting the Food and Drug Ad- (5) The results of an analysis of exist- ministration’s Office of Premarket Ap- ing toxicological information on the proval (HFS–200), 5001 Campus Dr., Col- substance and its impurities. This in- lege Park, MD 20740. For actions re- formation on the substance is needed quiring an environmental assessment, to show whether an animal carcinogen the agency’s finding of no significant bioassay has been carried out, or impact and the evidence supporting whether there is some other basis for that finding, contained in the peti- suspecting that the substance is a car- tioner’s environmental assessment, cinogen or potent toxin. This type of also will be available for public inspec- information on the impurities is need- tion at the Division of Dockets Man- ed to show whether any of them are agement in accordance with § 25.51(b)(2) carcinogenic, and, if carcinogenic, of this chapter. Requests for copies of whether their TD50 values are greater releasable information contained in than 6.25 milligrams per kilogram submissions requesting exemptions bodyweight per day in accordance with from the food additive regulations will paragraph (a)(1) of this section. be handled in accordance with the Food (6) Information on the environmental and Drug Administration’s Freedom of impact that would result from the pro- Information Act procedures, as de- posed use of the substance. The request scribed in part 20 of this chapter. In should contain either a claim for cat- particular, data and information that egorical exclusion as specified in § 25.32 fall within the definitions of a trade se- of this chapter or an environmental as- cret or confidential commercial or fi- sessment as specified in § 25.40 of this nancial information are not available chapter. for public disclosure in accordance (d) Data to be reviewed under this with § 20.61(c) of 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), 5001 not granted, the requestor may submit Campus Dr., College Park, MD 20740. a petition to the Food and Drug Ad- (e) The Food and Drug Administra- ministration for reconsideration of the tion will inform the requestor by letter decision in accordance with the provi- whether the specific food-contact ap- sions of § 10.33 of this chapter. plication is exempt from regulation as (g) If the Food and Drug Administra- a food additive or not. Although a sub- tion receives significant new informa- stance that migrates to food at a level tion that raises questions about the di- that results in a dietary concentration etary concentration or the safety of a at or below the threshold of regulation substance that the agency has exempt- will not be the subject of a regulation ed from regulation, the Food and Drug published in the FEDERAL REGISTER Administration may reevaluate the and will not appear in the Code of Fed- substance. If the Food and Drug Ad- eral Regulations, the Food and Drug ministration tentatively concludes

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that the information that is available in the Food and Drug Administration’s about the substance no longer supports guidance documents. an exemption for the use of the food- [60 FR 36595, July 17, 1995, as amended at 62 contact material from the food addi- FR 40599, July 29, 1997; 65 FR 56479, Sept. 19, tive regulations, the agency will notify 2000; 81 FR 49896, July 29, 2016] any persons that requested an exemption for the substance of its tentative Subpart C—Specific Administra- decision. The requestors will be given tive Rulings and Decisions an opportunity to show why the use of the substance should not be regulated § 170.45 Fluorine-containing com- under the food additive provisions of pounds. the act. If the requestors fail to ade- The Commissioner of Food and Drugs quately respond to the new evidence, has concluded that it is in the interest the agency will notify them that fur- of the public health to limit the addi- ther use of the substance in question tion of fluorine compounds to foods (a) for the particular use will require a to that resulting from the fluoridation food additive regulation. This notifica- of public water supplies, (b) to that re- tion will be placed on public display at sulting from the fluoridation of bottled the Division of Dockets Management water within the limitation established as part of the file of uses of substances in § 165.110(d) of this chapter, and (c) to that authorized by regulations (40 CFR exempted from regulation as food addi- part 180) under section 408 of the Act. tives. The Food and Drug Administra- tion recognizes that manufacturers [42 FR 14483, Mar. 15, 1977, as amended at 72 other than those that actually made a FR 10357 Mar. 8, 2007] request for exemption may also be § 170.50 Glycine (aminoacetic acid) in using exempted substances in food-con- food for human consumption. tact articles under conditions of use (a) Heretofore, the Food and Drug (e.g., use levels, temperature, type of Administration has expressed the opin- food contacted, etc.) that are similar to ion in trade correspondence that gly- those for which the exemption was cine is generally recognized as safe for issued. Because only requestors will be certain technical effects in human food notified as part of the revocation proc- when used in accordance with good ess described in this section, the Food manufacturing practice; however: and Drug Administration plans to no- (1) Reports in scientific literature in- tify other manufacturers by means of a dicate that adverse effects were found notice published in the FEDERAL REG- in cases where high levels of glycine ISTER of its decision to revoke an ex- were administered in diets of experi- emption issued for a specific use of a mental animals. substance in a food contact article. (2) Current usage information indi- (h) Guidance documents to assist re- cates that the daily dietary intake of questors in the preparation of submis- glycine by humans may be substan- sions seeking exemptions from the food tially increasing due to changing use additive regulations are available from patterns in food technology. the Food and Drug Administration’s Therefore, the Food and Drug Adminis- Office of Premarket Approval (HFS– tration no longer regards glycine and 200), 5001 Campus Dr., College Park, its salts as generally recognized as safe MD 20740. Interested persons are en- for use in human food and all out- couraged to obtain specific guidance standing letters expressing sanction for from the Food and Drug Administra- such use are rescinded. tion on the appropriate protocols to be (b) The Commissioner of Food and used for obtaining migration data, on Drugs concludes that by May 8, 1971, the validation of the analytical meth- manufacturers: ods used to quantify migration levels, (1) Shall reformulate food products on the procedures used to relate migra- for human use to eliminate added gly- tion data to dietary exposures, and on cine and its salts; or (2) Shall bring such products into any other issue not specifically covered compliance with an authorizing food

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additive regulation. A food additive pe- Subpart D—Premarket tition supported by toxicity data is re- Notifications quired to show that any proposed level of glycine or its salts added to foods for SOURCE: 67 FR 35729, May 21, 2002, unless human consumption will be safe. otherwise noted. (c) The status of glycine as generally recognized as safe for use in animal § 170.100 Submission of a premarket feed, as prescribed in § 582.5049 of this notification for a food contact subchapter, remains unchanged because stance (FCN) to the Food and Drug Administration (FDA). the additive is considered an essential nutrient in certain animal feeds and is (a) An FCN is effective for the food safe for such use under conditions of contact substance manufactured or good feeding practice. prepared by the manufacturer or supplier identified in the FCN submission. § 170.60 Nitrites and/or nitrates in cur- If another manufacturer or supplier ing premixes. wishes to market the same food contact substance for the same use, that (a) Nitrites and/or nitrates are food manufacturer or supplier must also additives when combined in curing pre- submit an FCN to FDA. mixes with spices and/or other fla- (1) An FCN must contain all of the voring or seasoning ingredients that information described in § 170.101. contain or constitute a source of sec- (2) An FCN may incorporate by ref- ondary or tertiary amines, including erence any information in FDA’s files but not limited to essential oils, diso- provided that the manufacturer or sup- dium inosinate, disodium guanylate, plier is authorized to reference the in- hydrolysates of animal or plant origin formation. The FCN must include in- (such as hydrolyzed vegetable protein), formation establishing that the manu- oleoresins of spices, soy products, and facturer or supplier is authorized to spice extractives. Such food additives reference information in FDA’s files. may be used only after the establish- (3) Any material submitted in or ref- ment of an authorizing food additive erenced by an FCN that is in a foreign regulation. A food additive petition language must be accompanied by an submitted pursuant to §§ 171.1 and English translation verified to be com- 171.100 of this chapter, supported by plete and accurate. data demonstrating that nitrosamines (b) FDA may choose not to accept an are not formed in curing premixes con- FCN for either of the following: taining such food additives, is required (1) A use of a food contact substance to establish safety. that is the subject of a regulation in (b) Nitrites and/or nitrates, when parts 173 through 189 of this chapter; or packaged separately from flavoring (2) A use of a food contact substance that is the subject of an exemption and seasoning in curing premixes, may under the threshold of regulation proc- continue to be used under prior sanc- ess described in § 170.39. tions in the commercial curing of meat (c) A petition must be submitted and meat products and poultry prod- under § 171.1 of this chapter to author- ucts and in accordance with the provi- ize the safe use of a food contact sub- sions of §§ 172.170 and 172.175 of this stance in either of the following cir- chapter that apply to meat curing cumstances, unless FDA agrees to ac- preparations for the home curing of cept an FCN for the proposed use. meat and meat products, including (1) The use of the food contact sub- poultry and wild game. To assure safe stance increases the cumulative die- use of such ingredients the labeling of tary concentration to a certain level. the premixes shall bear instructions to For a substance that is a biocide (e.g., the user that such separately packaged it is intended to exert microbial tox- ingredients are not to be combined icity), this level is equal to or greater until just prior to use. Encapsulating than 200 parts per billion in the daily or coating some or all of the ingredi- diet (0.6 milligram (mg)/person/day). ents does not constitute separate pack- For a substance that is not a biocide, aging. this level is equal to or greater than 1

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part per million in the daily diet (3 mg/ and Drug Administration (FDA), and person/day); or the report and signed certification of (2) There exists a bioassay on the the validating party must be submitted food contact substance, FDA has not as part of the notification. reviewed the bioassay, and the bio- (d) Information to address FDA’s re- assay is not clearly negative for car- sponsibility under the National Envi- cinogenic effects. ronmental Policy Act, in the form of (d) A manufacturer or supplier for either: which a notification is effective must (1) A claim of categorical exclusion keep a current address on file with under § 25.30 or § 25.32 of this chapter; or FDA. (2) An environmental assessment (1) The current address may be either complying with § 25.40 of this chapter. the manufacturer’s (or supplier’s) ad- (e) A completed and signed FDA dress or the address of the manufactur- Form No. 3480. er’s (or supplier’s) agent. (2) FDA will deliver correspondence § 170.102 Confidentiality of informa- to the manufacturer’s or supplier’s cur- tion in a premarket notification for rent address. a food contact substance (FCN). (a) During the 120-day period of the § 170.101 Information in a premarket Food and Drug Administration (FDA) notification for a food contact sub- review of an FCN, FDA will not dis- stance (FCN). close publicly any information in that An FCN must contain the following: FCN. (a) A comprehensive discussion of the (b) FDA will not disclose publicly the basis for the manufacturer’s or sup- information in an FCN that is with- plier’s determination that the use of drawn prior to the completion of FDA’s the food contact substance is safe. This review. discussion must: (c) Once FDA completes its review of (1) Discuss all information and data an FCN, the agency will make its con- submitted in the notification; and clusion about the FCN publicly avail- (2) Address any information and data able. For example, if FDA objects to a that may appear to be inconsistent notification 90 days after the date of with the determination that the pro- receipt, the agency would make avail- posed use of the food contact substance able its objection at that time. is safe. (d) By submitting an FCN to FDA, (b) All data and other information the manufacturer or supplier waives that form the basis of the determina- any claim to confidentiality of the in- tion that the food contact substance is formation required to adequately de- safe under the intended conditions of scribe the food contact substance and use. Data must include primary bio- the intended conditions of use that are logical data and chemical data. the subject of that FCN. (c) A good laboratory practice state- (e) The following data and informa- ment for each nonclinical laboratory tion in an FCN are available for public study, as defined under § 58.3(d) of this disclosure, unless extraordinary cir- chapter, that is submitted as part of cumstances are shown, on the 121st day the FCN, in the form of either: after receipt of the notification by (1) A signed statement that the study FDA, except that no data or informa- was conducted in compliance with the tion are available for public disclosure good laboratory practice regulations if the FCN is withdrawn under § 170.103. under part 58 of this chapter; or (1) All safety and functionality data (2) A brief signed statement listing and information submitted with or in- the reason(s) that the study was not corporated by reference into the notifi- conducted in compliance with part 58 cation. Safety and functionality data of this chapter. include all studies and tests of a food (3) Data from any study conducted contact substance on animals and hu- after 1978 but not conducted in compli- mans and all studies and tests on a ance with part 58 of this chapter must food contact substance for establishing be validated by an independent third identity, stability, purity, potency, party prior to submission to the Food performance, and usefulness.

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(2) A protocol for a test or study, un- (2) If FDA accepts an FCN, then FDA less it is exempt from disclosure under will acknowledge in writing its receipt § 20.61 of this chapter. of that FCN. (3) A list of all ingredients contained (c) Objection to an FCN: in a food contact substance, excluding (1) If FDA objects to an FCN, then information that is exempt from dis- FDA will send an FCN objection letter. closure under § 20.61 of this chapter. The date of the letter will be the date Where applicable, an ingredient list of FDA’s objection for purposes of sec- will be identified as incomplete. tion 409(h)(2)(A) of the act. (2) If FDA objects to an FCN within (4) An assay method or other analyt- the 120-day period for FDA review, the ical method, unless it serves no regu- FCN will not become effective. latory or compliance purpose and is ex- (3) FDA may object to an FCN if any empt from disclosure under § 20.61 of part of FDA’s 120-day review occurs this chapter. during a period when this program is (5) All correspondence and written not funded as required in section summaries of oral discussions relating 409(h)(5) of the act. to the notification, except information (d) If FDA and a manufacturer or that is exempt for disclosure under supplier agree that the notifier may § 20.61 of this chapter. submit a food additive petition pro- (6) All other information not subject posing the approval of the food contact to an exemption from disclosure under substance for the use in the manufac- subpart D of part 20 of this chapter. turer’s or supplier’s FCN, FDA will consider that FCN to be withdrawn by § 170.103 Withdrawal without preju- the manufacturer or supplier on the dice of a premarket notification for date the petition is received by FDA. a food contact substance (FCN). § 170.105 The Food and Drug Adminis- A manufacturer or supplier may tration’s (FDA’s) determination that withdraw an FCN without prejudice to a premarket notification for a food a future submission to the Food and contact substance (FCN) is no Drug Administration (FDA) if FDA has longer effective. not completed review of the FCN. For (a) If data or other information avail- the purpose of this section, FDA’s re- able to FDA, including data not sub- view is completed when FDA has al- mitted by the manufacturer or sup- lowed 120 days to pass without object- plier, demonstrate that the intended ing to the FCN or FDA has issued an use of the food contact substance is no objection letter. longer safe, FDA may determine that the authorizing FCN is no longer effec- § 170.104 Action on a premarket notifi- tive. cation for a food contact substance (b) If FDA determines that an FCN is (FCN). no longer effective, FDA will inform (a) If the Food and Drug Administra- the manufacturer or supplier in writing tion (FDA) does not object to an FCN of the basis for that determination. FDA will give the manufacturer or sup- within the 120-day period for FDA re- plier an opportunity to show why the view, the FCN becomes effective. FCN should continue to be effective (b) If an FCN is complete when re- and will specify the time that the man- ceived, the 120-day review period begins ufacturer or supplier will have to re- on the date FDA receives the FCN. spond. (1) If any element required under (c) If the manufacturer or supplier § 170.101 is missing from an FCN, then fails to respond adequately to the safe- FDA will not accept that FCN and FDA ty concerns regarding the notified use, will send an FCN nonacceptance letter FDA will publish a notice of its deter- to the manufacturer or supplier. If the mination that the FCN is no longer ef- manufacturer or supplier submits the fective. FDA will publish this notice in missing information before FDA sends the FEDERAL REGISTER, stating that a an FCN nonacceptance letter, the 120- detailed summary of the basis for day review period begins on the date of FDA’s determination that the FCN is receipt of the missing information. no longer effective has been placed on

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public display and that copies are your conclusion that the substance is available upon request. The date that GRAS under the conditions of its in- the notice publishes in the FEDERAL tended use in accordance with § 170.30. REGISTER is the date on which the noti- Notified substance means the sub- fication is no longer effective. stance that is the subject of your (d) FDA’s determination that an FCN GRAS notice. is no longer effective is final agency Notifier means the person (e.g., an in- action subject to judicial review. dividual, partnership, corporation, as- § 170.106 Notification for a food con- sociation, or other legal entity) who is tact substance formulation responsible for the GRAS notice, even (NFCSF). if another person (such as an attorney, (a) In order for the Food and Drug agent, or qualified expert) prepares or Administration (FDA) to accept an submits the notice or provides an opin- NFCSF, any food additive that is a ion about the basis for a conclusion of component of the formulation must be GRAS status. authorized for its intended use in that Qualified expert means an individual NFCSF. who is qualified by scientific training (b) FDA may publish a notice in the and experience to evaluate the safety FEDERAL REGISTER stating that the of substances under the conditions of agency has insufficient resources to re- their intended use in food. view NFCSFs. From the date that this Supplement means any data and infor- notice publishes in the FEDERAL REG- mation that you submit regarding a ISTER, FDA will no longer accept filed GRAS notice after we respond to NFCSFs. your notice by letter in accordance (c) An NFCSF must contain the fol- with § 170.265(b)(1) or cease to evaluate lowing: your notice in accordance with (1) A completed and signed FDA § 170.265(b)(3). Form No. 3479; and We, our, and us refer to the United (2) Any additional documentation re- States Food and Drug Administration quired to establish that each compo- (FDA). nent of the formulation already may be You and your refer to a notifier. marketed legally for its intended use. § 170.205 Opportunity to submit a Subpart E—Generally Recognized GRAS notice. as Safe (GRAS) Notice Any person may notify FDA of a view that a substance is not subject to the SOURCE: 81 FR 55048, Aug. 17, 2016, unless premarket approval requirements of otherwise noted. section 409 of the Federal Food, Drug, § 170.203 Definitions. and Cosmetic Act based on that person’s conclusion that the substance is The definitions and interpretations GRAS under the conditions of its in- of terms in § 170.3 apply to such terms tended use. when used in this subpart. The following definitions also apply: § 170.210 How to send your GRAS no- Amendment means any data and infor- tice to FDA. mation that you submit regarding a filed GRAS notice before we respond to (a) Send your GRAS notice to the Of- your notice by letter in accordance fice of Food Additive Safety (HFS–200), with § 170.265(b)(1) or cease to evaluate Center for Food Safety and Applied Nu- your notice in accordance with trition, Food and Drug Administration, § 170.265(b)(3). 5001 Campus Dr., College Park, MD GRAS means generally recognized as 20740. safe. (b) When you submit your GRAS no- GRAS notice means a submission that tice, you may do so either in an elec- informs us of your view that a sub- tronic format that is accessible for our stance is not subject to the premarket evaluation or on paper. If you send approval requirements of the Federal your GRAS notice on paper, a single Food, Drug, and Cosmetic Act based on paper copy is sufficient.

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§ 170.215 Incorporation into a GRAS population expected to consume the notice. notified substance; You may incorporate into your (5) Inform us of the statutory basis GRAS notice either specifically identi- for your conclusion of GRAS status fied data and information that you pre- (i.e., through scientific procedures in viously submitted to the Center for accordance with § 170.30(a) and (b) or Food Safety and Applied Nutrition through experience based on common (CFSAN), or specifically identified pub- use in food in accordance with licly available data and information § 170.30(a) and (c)); submitted by another party, when such (6) State your view that the notified data and information remain in substance is not subject to the pre- CFSAN’s records, such as data and in- market approval requirements of the formation contained in a previous Federal Food, Drug, and Cosmetic Act GRAS notice or a food additive peti- based on your conclusion that the noti- tion. fied substance is GRAS under the conditions of its intended use; § 170.220 General requirements appli- (7) State that, if we ask to see the cable to a GRAS notice. data and information that are the basis (a) A GRAS notice has seven parts as for your conclusion of GRAS status, ei- required by §§ 170.225 through 170.255. ther during or after our evaluation of You must submit the data and infor- your notice, you will: mation specified in each of these parts (i) Agree to make the data and infor- on separate pages or sets of pages. mation available to us; and (b) You must include each of the (ii) Agree to both of the following seven parts in your GRAS notice. If procedures for making the data and in- you do not include a part, you must information available to us: clude with your GRAS notice an expla- (A) Upon our request, you will allow nation of why that part does not apply us to review and copy the data and in- to your GRAS notice. formation during customary business hours at the address you specify for § 170.225 Part 1 of a GRAS notice: where these data and information will Signed statements and certification. be available to us; and (a) Part 1 of your GRAS notice must (B) Upon our request, you will pro- be dated and signed by a responsible of- vide us with a complete copy of the ficial of your organization, or by your data and information either in an elec- attorney or agent. tronic format that is accessible for our (b) Except as required by paragraph evaluation or on paper; (c)(8) of this section, you must not in- (8) State your view as to whether any clude any information that is trade se- of the data and information in Parts 2 cret or confidential commercial infor- through 7 of your GRAS notice are ex- mation in Part 1 of your GRAS notice. empt from disclosure under the Free- (c) In Part 1 of your GRAS notice, dom of Information Act, 5 U.S.C. 552 you must: (e.g., as trade secret or as commercial (1) Inform us that you are submitting or financial information that is privi- a GRAS notice in accordance with this leged or confidential). subpart; (9) Certify that, to the best of your (2) Provide the name and address of knowledge, your GRAS notice is a com- your organization; plete, representative, and balanced (3) Provide the name of the notified submission that includes unfavorable substance, using an appropriately de- information, as well as favorable infor- scriptive term; mation, known to you and pertinent to (4) Describe the intended conditions the evaluation of the safety and GRAS of use of the notified substance, includ- status of the use of the substance; ing the foods in which the substance (10) State both the name and position will be used, the levels of use in such or title of the person who signs the foods, and the purposes for which the GRAS notice; and substance will be used, including, when (11) When applicable, state as re- appropriate, a description of a sub- quired by § 170.270 whether you:

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(i) Authorize us to send any trade se- whether your conclusion of GRAS sta- crets to the Food Safety and Inspection tus is through scientific procedures or Service (FSIS) of the U.S. Department through experience based on common of Agriculture; or use in food, as follows: (ii) Ask us to exclude any trade se- (a) You must provide an estimate of crets from the copy of the GRAS notice dietary exposure to the notified sub- that we will send to FSIS. stance that includes exposure from its § 170.230 Part 2 of a GRAS notice: intended use and all sources in the Identity, method of manufacture, diet; and specifications, and physical or tech- (b) When applicable, you must pro- nical effect. vide an estimate of dietary exposure to In Part 2 of your GRAS notice, you any other substance that is expected to must include: be formed in or on food because of the (a) Scientific data and information use of the notified substance (e.g., that identifies the notified substance. hydrolytic products or reaction prod- (1) Examples of appropriate data and ucts); information include the chemical (c) When applicable, you must pro- name, applicable registry numbers vide an estimate of dietary exposure to (such as a Chemical Abstracts Service any other substance that is present (CAS) registry number or an Enzyme with the notified substance either nat- Commission (EC) number), empirical urally or due to its manufacture (e.g., formula, structural formula, quan- contaminants or by-products); titative composition, and char- (d) You must describe the source of acteristic properties. any food consumption data that you (2) When the source of a notified substance is a biological material, you use to estimate dietary exposure in ac- must include data and information suf- cordance with paragraphs (a) through ficient to identify: (c) of this section; and (i) The taxonomic source (e.g., genus, (e) You must explain any assump- species) including, as applicable, data tions you made to estimate dietary ex- and information at the sub-species posure in accordance with paragraphs level (e.g., variety, strain); (a) through (c) of this section. (ii) The part of any plant or animal used as the source; and § 170.240 Part 4 of a GRAS notice: Self- (iii) Any known toxicants that could limiting levels of use. be in the source; In circumstances where the amount (b) A description of the method of of the notified substance that can be manufacture of the notified substance added to food is limited because food in sufficient detail to evaluate the containing levels of the notified sub- safety of the notified substance as stance above a particular level would manufactured; become unpalatable or technologically (c) Specifications for food-grade ma- impractical, in Part 4 of your GRAS terial; and notice you must include data and infor- (d) When necessary to demonstrate mation on such self-limiting levels of safety, relevant data and information bearing on the physical or other tech- use. nical effect the notified substance is § 170.245 Part 5 of a GRAS notice: Ex- intended to produce, including the perience based on common use in quantity of the notified substance re- food before 1958. quired to produce such effect. If the statutory basis for your con- § 170.235 Part 3 of a GRAS notice: Die- clusion of GRAS status is through ex- tary exposure. perience based on common use in food, In part 3 of your GRAS notice, you in Part 5 of your GRAS notice you must provide data and information must include evidence of a substantial about dietary exposure (i.e., the history of consumption of the notified amount of relevant substances that substance for food use by a significant consumers are likely to eat or drink as number of consumers prior to January part of a total diet), regardless of 1, 1958.

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§ 170.250 Part 6 of a GRAS notice: Nar- basis for a conclusion of GRAS status rative. if qualified experts do not have access In Part 6 of your GRAS notice, you to such data and information. must include a narrative that provides the basis for your conclusion of GRAS § 170.255 Part 7 of a GRAS notice: List status, in which: of supporting data and information in your GRAS notice. (a)(1) You must explain why the data and information in your notice provide (a) In part 7 of your GRAS notice, a basis for your view that the notified you must include a list of all of the substance is safe under the conditions data and information that you discuss of its intended use. In your explain Part 6 of your GRAS notice to pro- nation, you must address the safety of vide a basis for your view that the no- the notified substance, considering all tified substance is safe under the condi- dietary sources and taking into actions of its intended use as described in count any chemically or pharmacologi- accordance with § 170.250(a)(1). cally related substances in such diet; (b) You must specify which data and (2) In your explanation, you must information that you list in accordance identify what specific data and infor- with paragraph (a) of this section are mation that you discuss in accordance generally available, and which data with paragraph (a)(1) of this section are and information are not generally generally available, and what specific available. data and information that you discuss in accordance with paragraph (a)(1) of § 170.260 Steps you may take before this section are not generally avail- FDA responds to your GRAS notice. able, by providing citations to the list (a) You may submit a timely amend- of data and information that you in- ment to your filed GRAS notice, to up- clude in Part 7 of your GRAS notice in date your GRAS notice or in response accordance with § 170.255; to a question from us, before we re- (b) You must explain how the gen- spond to your notice by letter in ac- erally available data and information cordance with § 170.265(b)(1) or cease to that you rely on to establish safety in evaluate your notice in accordance accordance with paragraph (a) of this with § 170.265(b)(3). section provide a basis for your conclu- (b) At any time before we respond to sion that the notified substance is gen- your GRAS notice in accordance with erally recognized, among qualified ex- § 170.265(b)(1), you may request in writ- perts, to be safe under the conditions of ing that we cease to evaluate your its intended use; (c) You must either: GRAS notice. Your request does not (1) Identify, discuss, and place in con- preclude you from submitting a future text, data and information that are, or GRAS notice in accordance with this may appear to be, inconsistent with subpart with respect to the notified your conclusion of GRAS status, re- substance. gardless of whether those data and in- § 170.265 What FDA will do with a formation are generally available; or GRAS notice. (2) State that you have reviewed the available data and information and are (a)(1) We will conduct an initial eval- not aware of any data and information uation of your submission to determine that are, or may appear to be, incon- whether to file it as a GRAS notice for sistent with your conclusion of GRAS evaluation of your view that the noti- status; fied substance is GRAS under the con- (d) If you view any of the data and in- ditions of its intended use. formation in your notice as exempt (2) If we file your submission as a from disclosure under the Freedom of GRAS notice, we will send you a letter Information Act, you must identify the that informs you of the date of filing. specific data and information; and (3) If we do not file your submission (e) For non-public, safety-related as a GRAS notice, we will send you a data and information considered in letter that informs you of that fact and reaching a conclusion of GRAS status, provides our reasons for not filing the you must explain how there could be a submission as a GRAS notice.

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(4) We will consider any timely in accordance with paragraph (a)(1) of amendment that you submit to a filed this section; and GRAS notice, to update your GRAS no- (c) We will ask FSIS to advise wheth- tice or in response to a question from er the intended conditions of use com- us, before we respond to you by letter ply with applicable statutes and regu- in accordance with paragraph (b)(1) of lations, or, if not, whether the use of this section, if we deem that doing so is the substance would be permitted in feasible within the timeframes estab- products under FSIS’ jurisdiction lished in paragraph (b) of this section. under specified conditions or restric- If we deem that considering your tions. amendment is not feasible within the timeframes established in paragraph (d) As appropriate, we will inform (b) of this section or if we have granted you of the advice we receive from FSIS your request to cease to evaluate your in the letter we send you in accordance notice, we will inform you that we are with § 170.265(b)(1). not considering your amendment. (b)(1) Within 180 days of filing, we § 170.275 Public disclosure of a GRAS will respond to you by letter based on notice. our evaluation of your notice. We may (a) The data and information in a extend the 180 day timeframe by 90 GRAS notice (including data and infor- days on an as needed basis. mation submitted in any amendment (2) If we extend the timeframe, we or supplement to your GRAS notice or will inform you in writing of the exten- incorporated into your GRAS notice) sion as soon as practicable but no later are: than within 180 days of filing. (1) Considered a mandatory, rather (3) If you ask us to cease to evaluate than voluntary, submission for pur- your GRAS notice in accordance with poses of their status under the Free- § 170.260(b), we will send you a letter in- dom of Information Act and our public forming you of our decision regarding information requirements in part 20 of your request. (c) If circumstances warrant, we will this chapter; and send you a subsequent letter about the (2) Available for public disclosure in notice. accordance with part 20 of this chapter as of the date that we receive your § 170.270 Procedures that apply when GRAS notice. the intended conditions of use of a (b) We will make the following read- notified substance include use in a ily accessible to the public: product or products subject to regulation by the Food Safety and In- (1) A list of filed GRAS notices, inspection Service (FSIS) of the cluding the information described in United States Department of Agri- § 170.225(c)(2) through (c)(5); culture. (2) The text of any letter that we If the intended conditions of use of issue under § 170.265(b)(1) or (c); and the notified substance include use in a (3) The text of any letter that we product or products subject to regula- issue under § 170.265(b)(3) if we grant tion by FSIS under statutes that it ad- your request that we cease to evaluate ministers: your notice. (a) When applicable, you must in- (c) We will disclose all remaining clude in your GRAS notice a statement data and information that are not ex- as to whether you: empt from public disclosure in accord- (1) Authorize us to send any trade se- ance with part 20 of this chapter. crets to FSIS; or (2) Ask us to exclude any trade se- § 170.280 Submission of a supplement. crets from the copy of the GRAS notice that we will send to FSIS. If circumstances warrant, you may (b)(1) We will forward a copy of a submit a supplement to a filed GRAS GRAS notice or relevant portions notice after we respond to your notice thereof to FSIS; by letter in accordance with (2) We will exclude any trade secrets § 170.265(b)(1) or cease to evaluate your unless you have authorized us to do so notice in accordance with § 170.265(b)(3).

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§ 170.285 Disposition of pending GRAS petition shall state petitioner’s post of- affirmation petitions. fice address to which published notices Because the procedure to submit a or orders issued or objections filed pur- GRAS notice is replacing the former suant to section 409 of the Act may be process to submit a GRAS affirmation sent. petition, the following will happen to a (b) Pertinent information may be in- filed GRAS affirmation petition that is corporated in, and will be considered as pending on October 17, 2016. part of, a petition on the basis of spe- (a) On October 17, 2016, we will close cific reference to such information sub- the docket for any GRAS affirmation mitted to and retained in the files of petition that is still pending as of Oc- the Food and Drug Administration. tober 17, 2016. However, any reference to unpublished (b) Any person who submitted a information furnished by a person GRAS affirmation petition described in other than the applicant will not be this section may submit a GRAS notice considered unless use of such informa- as described in this subpart and request tion is authorized in a written state- that we incorporate the GRAS affirma- ment signed by the person who sub- tion petition as described in § 170.215. mitted it. Any reference to published information offered in support of a food additive petition should be accom- PART 171—FOOD ADDITIVE panied by reprints or photostatic cop- PETITIONS ies of such references. (c) Petitions shall include the fol- Subpart A—General Provisions lowing data and be submitted in the Sec. following form: 171.1 Petitions. (Date) 171.6 Amendment of petition. Name of petitioner lllllllllllll 171.7 Withdrawal of petition without preju- Post-office address lllllllllllll dice. Date lllllllllllllllllllll 171.8 Threshold of regulation for substances Name of food additive and proposed use ll used in food-contact articles. llllllllllllllllllllllll Subpart B—Administrative Actions on Office of Food Additive Safety (HFS–200), Applications Center for Food Safety and Applied Nutri- tion, Food and Drug Administration, 5001 171.100 Regulation based on petition. Campus Dr., College Park, MD 20740. 171.102 Effective date of regulation. DEAR SIRS: 171.110 Procedure for objections and hear- The undersigned, lllll submits this ings. petition pursuant to section 409(b)(1) of the 171.130 Procedure for amending and repeal- Federal Food, Drug, and Cosmetic Act with ing tolerances or exemptions from toler- respect to lllll ances. (Name of the food additive and proposed use) AUTHORITY: 21 U.S.C. 321, 342, 348, 371. Attached hereto, in triplicate (quadru- SOURCE: 42 FR 14489, Mar. 15, 1977, unless plicate, if intended uses include use in meat, otherwise noted. meat food product, or poultry product), and constituting a part of this petition are the Subpart A—General Provisions following: A. The name and all pertinent information § 171.1 Petitions. concerning the food additive, including chemical identity and composition of the (a) Petitions to be filed with the food additive, its physical, chemical, and bi- Commissioner under the provisions of ological properties, and specifications pre- section 409(b) of the Federal Food, scribing the minimum content of the desired Drug, and Cosmetic Act (the act) shall component(s) and identifying and limiting be submitted in triplicate (quadru- the reaction byproducts and other impuri- plicate, if intended uses include use in ties. Where such information is not avail- meat, meat food product, or poultry able, a statement as to the reasons why it is not should be submitted. product). If any part of the material When the chemical identity and composi- submitted is in a foreign language, it tion of the food additive is not known, the shall be accompanied by an accurate petition shall contain information in suffi- and complete English translation. The cient detail to permit evaluation regarding

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