Indirect food substances affirmed as generally recognized as safe (21 CFR 186.1-186.1839)

590 21 CFR Ch. I (4–1–16 Edition) § 184.1985 It is produced commercially by extrac tion from corn gluten with alkaline aqueous isopropyl alcohol containing sodium hydroxide. The extract is then cooled, which causes the zein to pre cipitate. (b) The ingredient must be of a pu rity suitable for its intended use. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirma tion of this ingredient as generally rec ognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufac turing practice conditions of use: (1) The ingredient is used as a sur face-finishing agent as defined in § 170.3(o)(30) of this chapter. (2) The ingredient is used in food at levels not to exceed current good man ufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 8999, Mar. 6, 1985, as amended at 73 FR 8608, Feb. 14, 2008] § 184.1985 Aminopeptidase enzyme preparation derived from lactococcus lactis. (a) Aminopeptidase enzyme prepara tion is derived from the nonpathogenic and nontoxicogenic bacterium Lactococcus lactis (previously named Streptococcus lactis). The preparation contains the enzyme aminopeptidase (CAS Reg. No. 9031–94–1; EC 3.4.11.1) and other peptidases that hydrolyze milk proteins. The preparation is produced by pure culture fermentation. (b) The ingredient meets the speci fications for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), pp. 107–110, which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be exam ined at the Office of Food Additive Safety (HFS–200), Center for Food Safe ty and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1200, or at the National Ar chives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitations other than current good manufacturing practice. The affirma tion of this ingredient as generally rec ognized as safe as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an en zyme, as defined in § 170.3(o)(9) of this chapter, as an optional ingredient for flavor development in the manufacture of cheddar cheese, in accordance with § 133.113 of this chapter, and in the preparation of protein hydrolysates. (2) The ingredient is used at levels not to exceed current good manufac turing practice. [60 FR 54193, Oct. 20, 1995, as amended at 78 FR 14667, Mar. 7, 2013] PART 186—INDIRECT FOOD SUB STANCES AFFIRMED AS GEN ERALLY RECOGNIZED AS SAFE Subpart A—General Provisions Sec. 186.1 Substances added indirectly to human food affirmed as generally recognized as safe (GRAS). Subpart B—Listing of Specific Substances Affirmed as GRAS 186.1093 Sulfamic acid. 186.1256 Clay (kaolin). 186.1275 Dextrans. 186.1300 Ferric oxide. 186.1316 Formic acid. 186.1374 Iron oxides. 186.1551 Hydrogenated fish oil. 186.1555 Japan wax. 186.1557 Tall oil. 186.1673 Pulp. 186.1750 Sodium chlorite. 186.1756 Sodium formate. 186.1770 Sodium oleate. 186.1771 Sodium palmitate. 186.1797 Sodium sulfate. 186.1839 Sorbose. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. SOURCE: 42 FR 14658, Mar. 15, 1977, unless otherwise noted. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00600 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 591 Food and Drug Administration, HHS § 186.1 Subpart A—General Provisions § 186.1 Substances added indirectly to human food affirmed as generally recognized as safe (GRAS). (a) The indirect human food ingredi ents listed in this part have been re viewed by the Food and Drug Adminis tration and determined to be generally recognized as safe (GRAS) for the pur poses and under the conditions pre scribed, providing they comply with the purity specifications listed in this part or, in the absence of purity speci fications, are of a purity suitable for their intended use in accordance with § 170.30(h)(1) of this chapter. Certain in gredients in this part may also be used in food-contact surfaces in accordance with parts 174, 175, 176, 177, 178 or § 179.45 of this chapter. Ingredients af firmed as GRAS for direct use in part 184 of this chapter are also GRAS as in direct human food ingredients in ac cordance with § 184.1(a) of this chapter. (b) The regulations in this part do not authorize direct addition of any food ingredient to a food. They author ize only the use of these ingredients as indirect ingredients of food, through migration from their immediate wrap per, container, or other food-contact surface. Any ingredient affirmed as GRAS in this part shall be used in ac cordance with current good manufac turing practice. For the purpose of this part, current good manufacturing prac tice includes the requirements that an indirect human food ingredient be of a purity suitable for its intended use, and that it be used at a level no higher than reasonably required to achieve its intended technical effect in the food contact article. (1) If the ingredient is affirmed as GRAS with no limitations on its condi tions of use other than current good manufacturing practice, it shall be re garded as GRAS if its conditions of use are consistent with the requirements of paragraphs (b), (c), and (d) of this sec tion. When the Food and Drug Admin istration (FDA) determines that it is appropriate, the agency will describe one or more current good manufac turing practice conditions of use in the regulation that affirms the GRAS sta tus of the indirect ingredient. For ex ample, when the safety of an ingredient has been evaluated on the basis of lim ited conditions of use, the agency will describe in the regulation that affirms the GRAS status of the indirect ingre dient, one or more of these limited con ditions of use, which may include the category of food-contact surface(s), technical effect(s) or functional use(s) of the indirect ingredient, and the level(s) of use. If the ingredient is used under conditions that are significantly different from those described in the regulation, such use of a substance may not be GRAS. In such a case, a manufacturer may not rely on the reg ulation as authorizing that use but shall independently establish that the use is GRAS or shall use the ingredient in accordance with a food additive reg ulation. Persons seeking FDA approval of an independent determination that a use of an ingredient is GRAS may sub mit a GRAS petition in accordance with § 170.35 of this chapter. (2) If the ingredient is affirmed as GRAS with specific limitation(s), it shall be used in food-contact surfaces only within such limitation(s), includ ing the category of food-contact sur face(s), the functional use(s) of the in gredient, and the level(s) of use. Any use of such an ingredient not in full compliance with each such established limitation shall require a food additive regulation. (3) If the ingredient is affirmed as GRAS for a specific use, prior to gen eral evaluation of use of the ingredient, other uses may also be GRAS. (c) The listing of a food ingredient in this part does not authorize the use of such substance for the purpose of add ing the ingredient to the food through extraction from the food-contact sur face. (d) The listing of a food ingredient in this part does not authorize the use of such substance in a manner that may lead to deception to the consumer or to any other violation of the Federal Food, Drug, and Cosmetic Act (the Act). (e) If the Commissioner of Food and Drugs is aware of any prior sanction for use of an ingredient under condi tions different from those proposed to be affirmed as GRAS, he will concur rently propose a separate regulation covering such use of the ingredient VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00601 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 592 21 CFR Ch. I (4–1–16 Edition) § 186.1093 under part 181 of this chapter. If the Commissioner is unaware of any such applicable prior sanction, the proposed regulation will so state and will re quire any person who intends to assert or rely on such sanction to submit proof of its existence. Any regulation promulgated pursuant to this section constitutes a determination that ex cluded uses would result in adultera tion of the food in violation of section 402 of the Act, and the failure of any person to come forward with proof of such an applicable prior sanction in re sponse to the proposal will constitute a waiver of the right to assert or rely on such sanction at any later time. The notice will also constitute a proposal to establish a regulation under part 181 of this chapter, incorporating the same provisions, in the event that such a regulation is determined to be appro priate as a result of submission of proof of such an applicable prior sanction in response to the proposal. [42 FR 14658, Mar. 15, 1977, as amended at 48 FR 48457, 48459, Oct. 19, 1983] Subpart B—Listing of Specific Substances Affirmed as GRAS § 186.1093 Sulfamic acid. (a) Sulfamic acid (H3NO3S, CAS Reg. No. 5329–14–6) is a white crystalline solid manufactured from urea, sulfur trioxide, and sulfuric acid. It is soluble and highly ionized in water. (b) In accordance with § 186.1(b)(1), the ingredient is used as an indirect food ingredient with no limitations other than current good manufacturing practice. The affirmation of this ingre dient as generally recognized as safe (GRAS) as an indirect human food in gredient is based upon the current good manufacturing practice of using this ingredient in the manufacture of paper and paperboard that contact food. (c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [47 FR 29954, July 9, 1982] § 186.1256 Clay (kaolin). (a) Clay (kaolin) Al2O3.2SiO2.nH2O, Cas Reg. No. 1332–58–7) consists of hydrated aluminum silicate. The commercial products of clay (kaolin) contain vary ing quantities of alkalies and alkaline earths. Clay (kaolin) is a white to yel lowish or grayish fine powder. There are at least three different minerals, kaolinite, dickite, and nacrite, classi fied as kaolin. Kaolinite or china clay is whiter, less contaminated with ex traneous minerals, and less plastic in water. (b) In accordance with § 186.1(b)(1), the ingredient is used as an indirect human food ingredient with no limita tion other than current good manufac turing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used in the man ufacture of paper and paperboard that contact food. (2) The ingredient is used at levels not to exceed current good manufac turing practice. (c) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived. [47 FR 43367, Oct. 1, 1982] § 186.1275 Dextrans. (a) Dextrans (CAS Reg. No. 9004–54–0) are high molecular weight polysaccharides produced by bacterial fermentation of sucrose. Commercially available dextrans are synthesized from sucrose by Leuconostoc mesenteroides strain NRRL B–512(F). Partial depolymerization and purifi cation of the fermented mixture shall produce a product that is free of viable microorganisms. (b) The ingredient is used or intended for use as a constituent of food-contact surfaces. (c) The ingredient is used at levels not to exceed good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [43 FR 29288, July 7, 1978, as amended at 48 FR 48457, Oct. 19, 1983] VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00602 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 593 Food and Drug Administration, HHS § 186.1551 § 186.1300 Ferric oxide. (a) Ferric oxide (iron (III) oxide, Fe2O3, CAS Reg. No. 1309–37–1) occurs naturally as the mineral hematite. It may be prepared synthetically by heat ing brown iron hydroxide oxide. The product is red-brown to black trigonal crystals. (b) In accordance with § 186.1(b)(1), the ingredient is used as an indirect human food ingredient with no limita tion other than current good manufac turing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a con stituent of paper and paperboard used for food packaging. (2) The ingredient is used at levels not to exceed current good manufac turing practice. (c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988] § 186.1316 Formic acid. (a) Formic acid (CH2O2, CAS Reg. No. 64–18–6) is also referred to as methanoic acid or hydrogen carboxylic acid. It oc curs naturally in some insects and is contained in the free acid state in a number of plants. Formic acid is pre pared by the reaction of sodium for mate with sulfuric acid and is isolated by distillation. (b) Formic acid is used as a con stituent of paper and paperboard used for food packaging. (c) The ingredient is used at levels not to exceed good manufacturing practice in accordance with § 186.1(b)(1). (d) Prior sanctions for formic acid different from the uses established in this section do not exist or have been waived. [45 FR 22915, Apr. 4, 1980] § 186.1374 Iron oxides. (a) Iron oxides (oxides of iron, CAS Reg. No. 1332–37–2) are undefined mix tures of iron (II) oxide (CAS Reg. No. 1345–25–1, black cubic crystals) and iron (III) oxide (CAS Reg. No. 1309–37–1, red brown to black trigonal crystals). (b) In accordance with § 186.1(b)(1), the ingredient is used as an indirect human food ingredient with no limita tion other than current good manufac turing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a con stituent of paper and paperboard used for food packaging. (2) The ingredient is used at levels not to exceed current good manufac turing practice. (c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988, as amended at 69 FR 24512, May 4, 2004] § 186.1551 Hydrogenated fish oil. (a) Hydrogenated fish oil (CAS Reg. No. 91078–95–4) is a class of oils pro duced by partial hydrogenation of oils expressed from fish, primarily menha den, and secondarily herring or tuna. Hydrogenation of fish oils uses cata lysts composed of either elemental nickel, elemental copper, or a mixture of these elements. The crude hydro genated fish oil is further processed by alkali refining, bleaching, and deodori zation by steam stripping. (b) Hydrogenation of fish oils results in a final product with a melting point greater than 32 °C as determined by Section Cc 1–25, Official and Tentative Methods of the American Oil Chemists’ Society method (reapproved 1973) or equivalent. The product has an approx imate fatty acid composition of 30 to 45 percent saturated fatty acids, 40 to 55 percent monoenoic fatty acids, 7 to 15 percent dienoic fatty acids, 3 to 10 per cent trienoic fatty acids, and less than 2 percent tetraenoic or higher polyenoic fatty acids. The approximate percentages of total fatty acids by car bon chain length are 15 to 30 percent each of C16, C18, C20, C22, less than 10 percent C14 or lower carbon chain length, and less than 1 percent C24 or higher carbon chain length fatty acids. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00603 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 594 21 CFR Ch. I (4–1–16 Edition) § 186.1555 (c) The ingredient is used as a con stituent of cotton and cotton fabrics used for dry food packaging. (d) The ingredient is used at levels not to exceed good manufacturing practice in accordance with § 186.1(b)(1). (e) Prior sanctions for this ingredient different from the use established in this section do not exist or have been waived. [44 FR 28323, May 15, 1979, as amended at 49 FR 5614, Feb. 14, 1984; 58 FR 17099, Apr. 1, 1993] § 186.1555 Japan wax. (a) Japan wax (CAS Reg. No. 8001–39– 6), also known as Japan tallow or sumac wax, is a pale yellow vegetable tallow, containing glycerides of the C19-C23 dibasic acids and a high content of tripalmitin. It is prepared from the mesocarp by hot pressing of immature fruits of the oriental sumac, Rhus succedanea (Japan, Taiwan, and Indo China), R. vernicifera (Japan), and R. trichocarpa (China, Indo-China, India, and Japan). Japan wax is soluble in hot alcohol, benzene, and naphtha, and in soluble in water and in cold alcohol. (b) In accordance with paragraph (b)(1) of this section, the ingredient is used as an indirect human food ingre dient with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based on the following current good manufacturing practice conditions of use: (1) The ingredient is used as a con stituent of cotton and cotton fabrics used for dry food packaging. (2) The ingredient is used at levels not to exceed current good manufac turing practice. (c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [60 FR 62208, Dec. 5, 1995] § 186.1557 Tall oil. (a) Tall oil (CAS Reg. No. 8002–26–4) is essentially the sap of the pine tree. It is obtained commercially from the waste liquors of pinewood pulp mills and consists mainly of tall oil resin acids and tall oil fatty acids. (b) In accordance with § 186.1(b)(1), the ingredient is used as an indirect human food ingredient with no limita tion other than current good manufac turing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based on the following current good manufacturing practice conditions of use: (1) The ingredient is used as a con stituent of cotton and cotton fabrics used for dry food packaging. (2) The ingredient is used at levels not to exceed current good manufac turing practice. (c) Prior sanctions for this ingredient different from the uses established in this section, or from those listed in part 181 of this chapter, do not exist or have been waived. [51 FR 16830, May 7, 1986] § 186.1673 Pulp. (a) Pulp is the soft, spongy pith in side the stem of a plant such as wood, straw, sugarcane, or other natural plant sources. (b) The ingredient is used or intended for use as a constituent of food pack aging containers. (c) The ingredient is used in paper and paperboard made by conventional paper-making processes at levels not to exceed good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. § 186.1750 Sodium chlorite. (a) Sodium chlorite (NaCLO2, CAS Reg. No. 7758–19–2) exists as slightly hygroscopic white crystals or flakes. It is manufactured by passing chlorine di oxide into a solution of sodium hydrox ide and hydrogen peroxide. (b) the ingredient is used at levels from 125 to 250 parts per million as a slimicide in the manufacture of paper and paperboard that contact food. [45 FR 16470, Mar. 14, 1980] § 186.1756 Sodium formate. (a) Sodium formate (CHNaO2, CAS Reg. No. 141–53–7) is the sodium salt of VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00604 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 595 Food and Drug Administration, HHS § 186.1839 formic acid. It is produced by the reac tion of carbon monoxide with sodium hydroxide. (b) The ingredient is used as a con stituent of paper and paperboard used for food packaging. (c) The ingredient is used at levels not to exceed good manufacturing practice in accordance with § 186.1(b)(1). (d) Prior sanctions for sodium for mate different from the uses estab lished in this section do not exist or have been waived. [45 FR 22915, Apr. 4, 1980] § 186.1770 Sodium oleate. (a) Sodium oleate (C18H33O2Na, CAS Reg. No. 143–19–1) is the sodium salt of oleic acid (cis-9-octadecenoic acid). It exists as a white to yellowish powder with a slight tallow-like odor. Com mercially, sodium oleate is made by mixing and heating flaked sodium hy droxide and oleic acid. (b) In accordance with § 186.1(b)(1), the ingredient is used as a constituent of paper and paperboard for food pack aging and as a component of lubricants with incidental food contact in accord ance with § 178.3570 of this chapter, with no limitation other than current good manufacturing practice. (c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [51 FR 39372, Oct. 28, 1986] § 186.1771 Sodium palmitate. (a) Sodium palmitate (C16H31O2Na, CAS Reg. No. 408–35–5) is the sodium salt of palmitic acid (hexadecanoic acid). It exists as a white to yellow powder. Commercially, sodium palmitate is made by mixing and heat ing flaked sodium hydroxide and pal mitic acid. (b) In accordance with § 186.1(b)(1), the ingredient is used as a constituent of paper and paperboard for food pack aging with no limitation other than current good manufacturing practice. (c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [51 FR 39372, Oct. 28, 1986] § 186.1797 Sodium sulfate. (a) Sodium sulfate (Na2SO4, CAS Reg. No. 7757–82–6), also known as Glauber’s salt, occurs naturally and exists as colorless crystals or as a fine, white crystalline powder. It is prepared by the neutralization of sulfuric acid with sodium hydroxide. (b) The ingredient is used as a con stituent of paper and paperboard used for food packaging, and cotton and cot ton fabric used for dry food packaging. (c) The ingredient is used at levels not to exceed good manufacturing practice in accordance with § 186.1(b)(1). (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [45 FR 6086, Jan. 25, 1980] § 186.1839 Sorbose. (a) Sorbose (L-sorbose, sorbinose) (C6H12O6, CAS Reg. No. 87–79–6) is an orthorhombic, bisphenoidal crystalline ketohexose. It was originally identifed in the juice of mature berries from the mountain ash (Sorbus aucuparia) where it occurs as the result of microbial oxi dation of sorbitol. It also occurs natu rally in other plants. Sorbose can be synthesized by the catalytic hydro genation of glucose to D-sorbitol. The resulting sorbitol can be oxidized by Acetobacter xylinum or by Acetobacter suboxydans. (b) The ingredient is used or intended for indirect food use as a constituent of cotton, cotton fabrics, paper, and pa perboard in contact with dry food. (c) The ingredient migrates to food at levels not to exceed good manufac turing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [43 FR 11698, Mar. 21, 1978, as amended at 48 FR 48457, Oct. 19, 1983] VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00605 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R