§ 181.33 21 CFR Ch. I (4–1–06 Edition) (c) Acrylonitrile monomer may 182.90 Substances migrating to food from present a hazard to health when in- paper and paperboard products. gested. Accordingly, any food-contact 182.99 Adjuvants for pesticide chemicals. article containing acrylonitrile copoly- Subpart B—Multiple Purpose GRAS Food mers or resins that yield acrylonitrile Substances monomer in excess of that amount pro- vided for in paragraph (b) of this sec- 182.1045 Glutamic acid. tion shall be deemed to be adulterated 182.1047 Glutamic acid hydrochloride. in violation of section 402 of the Act. 182.1057 Hydrochloric acid. 182.1073 Phosphoric acid. [42 FR 14638, Mar. 15, 1977, as amended at 47 182.1087 Sodium acid pyrophosphate. FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, 182.1125 Aluminum sulfate. 1989] 182.1127 Aluminum ammonium sulfate. 182.1129 Aluminum potassium sulfate. § 181.33 Sodium nitrate and potassium 182.1131 Aluminum sodium sulfate. nitrate. 182.1180 Caffeine. Sodium nitrate and potassium ni- 182.1217 Calcium phosphate. 182.1235 Caramel. trate are subject to prior sanctions 182.1320 Glycerin. issued by the U.S. Department of Agri- 182.1480 Methylcellulose. culture for use as sources of nitrite, 182.1500 Monoammonium glutamate. with or without sodium or potassium 182.1516 Monopotassium glutamate. nitrite, in the production of cured red 182.1711 Silica aerogel. meat products and cured poultry prod- 182.1745 Sodium carboxymethylcellulose. ucts. 182.1748 Sodium caseinate. 182.1778 Sodium phosphate. [48 FR 1705, Jan. 14, 1983] 182.1781 Sodium aluminum phosphate. 182.1810 Sodium tripolyphosphate. § 181.34 Sodium nitrite and potassium nitrite. Subpart C—Anticaking Agents Sodium nitrite and potassium nitrite 182.2122 Aluminum calcium silicate. are subject to prior sanctions issued by 182.2227 Calcium silicate. the U.S. Department of Agriculture for 182.2437 Magnesium silicate. use as color fixatives and preservative 182.2727 Sodium aluminosilicate. agents, with or without sodium or po- 182.2729 Sodium calcium aluminosilicate, tassium nitrate, in the curing of red hydrated. meat and poultry products. 182.2906 Tricalcium silicate. [48 FR 1705, Jan. 14, 1983] Subpart D—Chemical Preservatives 182.3013 Ascorbic acid. PART 182—SUBSTANCES 182.3041 Erythorbic acid. GENERALLY RECOGNIZED AS SAFE 182.3089 Sorbic acid. 182.3109 Thiodipropionic acid. Subpart A—General Provisions 182.3149 Ascorbyl palmitate. 182.3169 Butylated hydroxyanisole. Sec. 182.3173 Butylated hydroxytoluene. 182.1 Substances that are generally recog- 182.3189 Calcium ascorbate. nized as safe. 182.3225 Calcium sorbate. 182.10 Spices and other natural seasonings 182.3280 Dilauryl thiodipropionate. and flavorings. 182.3616 Potassium bisulfite. 182.20 Essential oils, oleoresins (solvent- 182.3637 Potassium metabisulfite. free), and natural extractives (including 182.3640 Potassium sorbate. distillates). 182.3731 Sodium ascorbate. 182.40 Natural extractives (solvent-free) 182.3739 Sodium bisulfite. used in conjunction with spices, 182.3766 Sodium metabisulfite. seasonings, and flavorings. 182.3795 Sodium sorbate. 182.50 Certain other spices, seasonings, es- 182.3798 Sodium sulfite. sential oils, oleoresins, and natural ex- 182.3862 Sulfur dioxide. tracts. 182.3890 Tocopherols. 182.60 Synthetic flavoring substances and adjuvants. Subpart E—Emulsifying Agents [Reserved] 182.70 Substances migrating from cotton and cotton fabrics used in dry food pack- Subpart F—Dietary Supplements aging. [Reserved] 466 VerDate Aug<31>2005 02:24 Apr 21, 2006 Jkt 208067 PO 00000 Frm 00476 Fmt 8010 Sfmt 8006 Y:\SGML\208067.XXX 208067 Food and Drug Administration, HHS § 182.10 Subpart G—Sequestrants defined to include the following re- strictions: 182.6085 Sodium acid phosphate. 182.6197 Calcium diacetate. (1) The quantity of a substance added 182.6203 Calcium hexametaphosphate. to food does not exceed the amount 182.6215 Monobasic calcium phosphate. reasonably required to accomplish its 182.6285 Dipotassium phosphate. intended physical, nutritional, or other 182.6290 Disodium phosphate. technical effect in food; and 182.6757 Sodium gluconate. (2) The quantity of a substance that 182.6760 Sodium hexametaphosphate. becomes a component of food as a re- 182.6769 Sodium metaphosphate. 182.6778 Sodium phosphate. sult of its use in the manufacturing, 182.6787 Sodium pyrophosphate. processing, or packaging of food, and 182.6789 Tetra sodium pyrophosphate. which is not intended to accomplish 182.6810 Sodium tripolyphosphate. any physical or other technical effect in the food itself, shall be reduced to Subpart H—Stabilizers the extent reasonably possible. 182.7255 Chondrus extract. (3) The substance is of appropriate food grade and is prepared and handled Subpart I—Nutrients as a food ingredient. Upon request the Commissioner will offer an opinion, 182.8013 Ascorbic acid. 182.8159 Biotin. based on specifications and intended 182.8217 Calcium phosphate. use, as to whether or not a particular 182.8223 Calcium pyrophosphate. grade or lot of the substance is of suit- 182.8250 Choline bitartrate. able purity for use in food and would 182.8252 Choline chloride. generally be regarded as safe for the 182.8778 Sodium phosphate. purpose intended, by experts qualified 182.8890 Tocopherols. to evaluate its safety. 182.8892 a-Tocopherol acetate. 182.8985 Zinc chloride. (c) The inclusion of substances in the 182.8988 Zinc gluconate. list of nutrients does not constitute a 182.8991 Zinc oxide. finding on the part of the Department 182.8994 Zinc stearate. that the substance is useful as a sup- 182.8997 Zinc sulfate. plement to the diet for humans. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. (d) Substances that are generally rec- ognized as safe for their intended use SOURCE: 42 FR 14640, Mar. 15, 1977, unless otherwise noted. within the meaning of section 409 of the act are listed in this part. When the status of a substance has been re- Subpart A—General Provisions evaluated, it will be deleted from this § 182.1 Substances that are generally part, and will be issued as a new regu- recognized as safe. lation under the appropriate part, e.g., ‘‘affirmed as GRAS’’ under part 184 or (a) It is impracticable to list all sub- 186 of this chapter; ‘‘food additive regu- stances that are generally recognized lation’’ under parts 170 through 180 of as safe for their intended use. However, this chapter; ‘‘interim food additive by way of illustration, the Commis- regulation’’ under part 180 of this chap- sioner regards such common food in- ter; or ‘‘prohibited from use in food’’ gredients as salt, pepper, vinegar, bak- under part 189 of this chapter. ing powder, and monosodium glu- tamate as safe for their intended use. [42 FR 14640, Mar. 15, 1977, as amended at 53 This part includes additional sub- FR 44875, Nov. 7, 1988] stances that, when used for the pur- poses indicated, in accordance with § 182.10 Spices and other natural good manufacturing practice, are re- seasonings and flavorings. garded by the Commissioner as Spices and other natural seasonings generaly recognized as safe for such and flavorings that are generally rec- uses. ognized as safe for their intended use, (b) For the purposes of this section, within the meaning of section 409 of good manufacturing practice shall be the Act, are as follows: 467 VerDate Aug<31>2005 02:24 Apr 21, 2006 Jkt 208067 PO 00000 Frm 00477 Fmt 8010 Sfmt 8010 Y:\SGML\208067.XXX 208067 § 182.10 21 CFR Ch. I (4–1–06 Edition) Common name Botanical name of plant source Alfalfa herb and seed .............................................. Medicago sativa L. Allspice .................................................................... Pimenta officinalis Lindl. Ambrette seed ......................................................... Hibiscus abelmoschus L. Angelica ................................................................... Angelica archangelica L. or other spp. of Angelica. Angelica root ........................................................... Do. Angelica seed .......................................................... Do. Angostura (cusparia bark) ....................................... Galipea officinalis Hancock. Anise ....................................................................... Pimpinella anisum L. Anise, star ............................................................... Illicium verum Hook. f. Balm (lemon balm) .................................................. Melissa officinalis L. Basil, bush ............................................................... Ocimum minimum L. Basil, sweet ............................................................. Ocimum basilicum L. Bay .......................................................................... Laurus nobilis L. Calendula ................................................................ Calendula officinalis L. Camomile (chamomile), English or Roman ............ Anthemis nobilis L. Camomile (chamomile), German or Hungarian ...... Matricaria chamomilla L. Capers ..................................................................... Capparis spinosa L. Capsicum ................................................................ Capsicum frutescens L. or Capsicum annuum L. Caraway .................................................................. Carum carvi L. Caraway, black (black cumin) ................................. Nigella sativa L. Cardamom (cardamon) ........................................... Elettaria cardamomum Maton. Cassia, Chinese ...................................................... Cinnamomum