SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (CONTINUED) PART 170—FOOD ADDITIVES 170.106 Notification for a food contact sub- stance 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 ex- posure. 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 no- tice. 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 affir- mation petitions. 170.100 Submission of a premarket notifica- tion 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. 5 VerDate Sep<11>2014 11:35 Jun 28, 2017 Jkt 241072 PO 00000 Frm 00015 Fmt 8010 Sfmt 8010 Y:\SGML\241072.XXX 241072 pmangrum on DSK3GDR082PROD with CFR § 170.3 21 CFR Ch. I (4–1–17 Edition) (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 6 VerDate Sep<11>2014 11:35 Jun 28, 2017 Jkt 241072 PO 00000 Frm 00016 Fmt 8010 Sfmt 8010 Y:\SGML\241072.XXX 241072 pmangrum on DSK3GDR082PROD with CFR Food and Drug Administration, HHS § 170.3 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.