Food and Drug Administration, HHS Pt. 186 It is produced commercially by extrac- tion on the availability of this mate- tion from corn gluten with alkaline rial at NARA, call 202–741–6030, or go aqueous isopropyl alcohol containing to: http://www.archives.gov/ sodium hydroxide. The extract is then federallregister/ cooled, which causes the zein to pre- codeloflfederallregulations/ cipitate. ibrllocations.html. (b) The ingredient must be of a pu- (c) In accordance with § 184.1(b)(1), rity suitable for its intended use. the ingredient is used in food with no (c) In accordance with § 184.1(b)(1), limitations other than current good the ingredient is used in food with no manufacturing practice. The affirma- limitation other than current good tion of this ingredient as generally rec- manufacturing practice. The affirma- ognized as safe as a direct human food tion of this ingredient as generally rec- ingredient is based upon the following ognized as safe (GRAS) as a direct current good manufacturing practice human food ingredient is based upon conditions of use: the following current good manufac- (1) The ingredient is used as an en- turing practice conditions of use: zyme, as defined in § 170.3(o)(9) of this (1) The ingredient is used as a sur- chapter, as an optional ingredient for face-finishing agent as defined in flavor development in the manufacture § 170.3(o)(30) of this chapter. of cheddar cheese, in accordance with (2) The ingredient is used in food at § 133.113 of this chapter, and in the levels not to exceed current good man- preparation of protein hydrolysates. ufacturing practice. (2) The ingredient is used at levels (d) Prior sanctions for this ingredient not to exceed current good manufac- different from the uses established in turing practice. this section do not exist or have been waived. [60 FR 54193, Oct. 20, 1995, as amended at 78 FR 14667, Mar. 7, 2013] [50 FR 8999, Mar. 6, 1985, as amended at 73 FR 8608, Feb. 14, 2008] PART 186—INDIRECT FOOD SUB- § 184.1985 Aminopeptidase enzyme STANCES AFFIRMED AS GEN- preparation derived from ERALLY RECOGNIZED AS SAFE lactococcus lactis. (a) Aminopeptidase enzyme prepara- Subpart A—General Provisions tion is derived from the nonpathogenic Sec. and nontoxicogenic bacterium 186.1 Substances added indirectly to human Lactococcus lactis (previously named food affirmed as generally recognized as Streptococcus lactis). The preparation safe (GRAS). contains the enzyme aminopeptidase (CAS Reg. No. 9031–94–1; EC 3.4.11.1) and Subpart B—Listing of Specific Substances other peptidases that hydrolyze milk Affirmed as GRAS proteins. The preparation is produced 186.1093 Sulfamic acid. by pure culture fermentation. 186.1256 Clay (kaolin). (b) The ingredient meets the speci- 186.1275 Dextrans. fications for enzyme preparations in 186.1300 Ferric oxide. the Food Chemicals Codex, 3d ed. (1981), 186.1316 Formic acid. pp. 107–110, which are incorporated by 186.1374 Iron oxides. 186.1551 Hydrogenated fish oil. reference in accordance with 5 U.S.C. 186.1555 Japan wax. 552(a) and 1 CFR part 51. Copies are 186.1557 Tall oil. available from the National Academy 186.1673 Pulp. Press, 2101 Constitution Ave. NW., 186.1750 Sodium chlorite. Washington, DC 20418, or may be exam- 186.1756 Sodium formate. ined at the Office of Food Additive 186.1770 Sodium oleate. Safety (HFS–200), Center for Food Safe- 186.1771 Sodium palmitate. ty and Applied Nutrition, Food and 186.1797 Sodium sulfate. 186.1839 Sorbose. Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–1200, or AUTHORITY: 21 U.S.C. 321, 342, 348, 371. at the National Archives and Records SOURCE: 42 FR 14658, Mar. 15, 1977, unless Administration (NARA). For informa- otherwise noted. 593 VerDate Sep<11>2014 17:56 Jun 11, 2019 Jkt 247072 PO 00000 Frm 00603 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB § 186.1 21 CFR Ch. I (4–1–19 Edition) Subpart A—General Provisions has been evaluated on the basis of lim- ited conditions of use, the agency will § 186.1 Substances added indirectly to describe in the regulation that affirms human food affirmed as generally the GRAS status of the indirect ingre- recognized as safe (GRAS). dient, one or more of these limited con- (a) The indirect human food ingredi- ditions of use, which may include the ents listed in this part have been re- category of food-contact surface(s), viewed by the Food and Drug Adminis- technical effect(s) or functional use(s) tration and affirmed to be generally of the indirect ingredient, and the recognized as safe (GRAS) for the pur- level(s) of use. If the ingredient is used poses and under the conditions pre- under conditions that are significantly scribed, providing they comply with different from those described in the the purity specifications listed in this regulation, such use of a substance part or, in the absence of purity speci- may not be GRAS. In such a case, a fications, are of a purity suitable for manufacturer may not rely on the reg- their intended use in accordance with ulation as authorizing that use but § 170.30(h)(1) of this chapter. Certain in- shall have a basis to conclude that the gredients in this part may also be used use is GRAS or shall use the ingredient in food-contact surfaces in accordance in accordance with a food additive reg- with parts 174, 175, 176, 177, 178 or ulation. § 179.45 of this chapter. Ingredients af- (2) If the ingredient is affirmed as firmed as GRAS for direct use in part GRAS with specific limitation(s), it 184 of this chapter are also GRAS as in- shall be used in food-contact surfaces direct human food ingredients in ac- only within such limitation(s), includ- cordance with § 184.1(a) of this chapter. ing the category of food-contact sur- (b) The regulations in this part do face(s), the functional use(s) of the in- not authorize direct addition of any gredient, and the level(s) of use. Any food ingredient to a food. They author- use of such an ingredient not in full ize only the use of these ingredients as compliance with each such established indirect ingredients of food, through limitation shall require a food additive migration from their immediate wrap- regulation. per, container, or other food-contact (3) If the ingredient is affirmed as surface. Any ingredient affirmed as GRAS for a specific use, prior to gen- GRAS in this part shall be used in ac- eral evaluation of use of the ingredient, cordance with current good manufac- other uses may also be GRAS. turing practice. For the purpose of this part, current good manufacturing prac- (c) The listing of a food ingredient in tice includes the requirements that an this part does not authorize the use of indirect human food ingredient be of a such substance for the purpose of add- purity suitable for its intended use, ing the ingredient to the food through and that it be used at a level no higher extraction from the food-contact sur- than reasonably required to achieve its face. intended technical effect in the food- (d) The listing of a food ingredient in contact article. this part does not authorize the use of (1) If the ingredient is affirmed as such substance in a manner that may GRAS with no limitations on its condi- lead to deception to the consumer or to tions of use other than current good any other violation of the Federal manufacturing practice, it shall be re- Food, Drug, and Cosmetic Act (the garded as GRAS if its conditions of use Act). are consistent with the requirements of (e) If the Commissioner of Food and paragraphs (b), (c), and (d) of this sec- Drugs is aware of any prior sanction tion. When the Food and Drug Admin- for use of an ingredient under condi- istration (FDA) determines that it is tions different from those proposed to appropriate, the agency will describe be affirmed as GRAS, he will concur- one or more current good manufac- rently propose a separate regulation turing practice conditions of use in the covering such use of the ingredient regulation that affirms the GRAS sta- under part 181 of this chapter. If the tus of the indirect ingredient. For ex- Commissioner is unaware of any such ample, when the safety of an ingredient applicable prior sanction, the proposed 594 VerDate Sep<11>2014 17:56 Jun 11, 2019 Jkt 247072 PO 00000 Frm 00604 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB Food and Drug Administration, HHS § 186.1300 regulation will so state and will re- earths. Clay (kaolin) is a white to yel- quire any person who intends to assert lowish or grayish fine powder. There or rely on such sanction to submit are at least three different minerals, proof of its existence. Any regulation kaolinite, dickite, and nacrite, classi- promulgated pursuant to this section fied as kaolin. Kaolinite or china clay constitutes a determination that ex- is whiter, less contaminated with ex- cluded uses would result in adultera- traneous minerals, and less plastic in tion of the food in violation of section water. 402 of the Act, and the failure of any (b) In accordance with § 186.1(b)(1), person to come forward with proof of the ingredient is used as an indirect such an applicable prior sanction in re- human food ingredient with no limita- sponse to the proposal will constitute a tion other than current good manufac- waiver of the right to assert or rely on turing practice.