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Home , Cayenne pepper, Erythroxylum coca, Monoammonium glutamate

§ 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 . 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 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 . 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 and other natural 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

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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 , 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:

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Common name Botanical name of source

Alfalfa and seed ...... Medicago sativa L. ...... Pimenta officinalis Lindl. Ambrette seed ...... Hibiscus abelmoschus L. Angelica ...... L. or other spp. of Angelica. Angelica root ...... Do. Angelica seed ...... Do. Angostura (cusparia bark) ...... Galipea officinalis Hancock. ...... Pimpinella anisum L. Anise, star ...... Hook. f. Balm () ...... Melissa officinalis L. , bush ...... Ocimum minimum L. Basil, sweet ...... Ocimum basilicum L. Bay ...... 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. ...... L. or L. ...... Carum carvi L. Caraway, black (black ) ...... L. (cardamon) ...... Elettaria cardamomum Maton. Cassia, Chinese ...... Blume. Cassia, Padang or Batavia ...... Cinnamomum burmanni Blume. Cassia, Saigon ...... Cinnamomum loureirii Nees. Cayenne pepper ...... Capsicum frutescens L. or Capsicum annuum L. seed ...... Apium graveolens L. ...... Anthriscus cerefolium (L.) Hoffm. ...... Allium schoenoprasum L. , Ceylon ...... Cinnamomum zeylanicum Nees. Cinnamon, Chinese ...... Cinnamomum cassia Blume. Cinnamon, Saigon ...... Cinnamomum loureirii Nees. Clary (clary sage) ...... Salvia sclarea L. Clover ...... Trifolium spp. ...... Coriandrum sativum L. Cumin (cummin) ...... Cuminum cyminum L. Cumin, black (black caraway) ...... Nigella sativa L. Elder flowers ...... Sambucus canadensis L. , common ...... Foeniculum vulgare Mill. Fennel, sweet (finocchio, Florence fennel) ...... Foeniculum vulgare Mill. var. duice (DC.) Alex. ...... Trigonella foenum-graecum L. Galanga () ...... Hance. Geranium ...... Pelargonium spp. ...... Zingiber officinale Rosc. Grains of paradise ...... Amomum melegueta Rosc. Horehound (hoarhound) ...... Marrubium vulgare L. ...... Armoracia lapathifolia Gilib. Hyssop ...... L. Lavender ...... Lavandula officinalis Chaix. Linden flowers ...... Tilia spp. Mace ...... Myristica fragrans Houtt. Marigold, pot ...... Calendula officinalis L. , pot ...... Majorana onites (L.) Benth. Marjoram, sweet ...... Majorana hortensis Moench. , black or brown ...... (L.) Koch. Mustard, brown ...... (L.) Coss. Mustard, white or yellow ...... Brassica hirta Moench. ...... Myristica fragrans Houtt. (oreganum, Mexican oregano, Mexican Lippia spp. sage, origan). ...... Capsicum annuum L. ...... Petroselinum crispum (Mill.) Mansf. Pepper, black ...... Piper nigrum L. Pepper, cayenne ...... Capsicum frutescens L. or Capsicum annuum L. Pepper, red ...... Do. Pepper, white ...... Piper nigrum L. ...... piperita L. ...... Papayer somniferum L. Pot marigold ...... Calendula officinalis L. Pot marjoram ...... Majorana onites (L.) Benth. ...... Rosmarinus officinalis L. ...... Crocus sativus L. Sage ...... L. Sage, Greek ...... Salvia triloba L. Savory, summer ...... Satureia hortensis L. ().

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Common name Botanical name of plant source

Savory, winter ...... Satureia montana L. (Satureja). ...... Sesamum indicum L. ...... Mentha spicata L. Star anise ...... Illicium verum Hook. f. ...... Artemisia dracunculus L. ...... Thymus vulgaris L. Thyme, wild or creeping ...... Thymus serpyllum L. ...... Curcuma longa L. ...... Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore. Zedoary ...... Rosc.

[42 FR 14640, Mar. 15, 1977, as amended at 43 FR 3705, Jan. 27, 1978; 44 FR 3963, Jan. 19, 1979; 50 FR 21044, May 22, 1985; 61 FR 14246, Apr. 1, 1996]

§ 182.20 Essential oils, oleoresins (sol- ing distillates) that are generally rec- vent-free), and natural extractives ognized as safe for their intended use, (including distillates). within the meaning of section 409 of Essential oils, oleoresins (solvent- the Act, are as follows: free), and natural extractives (includ-

Common name Botanical name of plant source

Alfalfa ...... Medicago sativa L. Allspice ...... Pimenta officinalis Lindl. Almond, bitter (free from prussic acid) ...... Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch. Ambrette (seed) ...... Hibiscus moschatus Moench. Angelica root ...... Angelica archangelica L. Angelica seed ...... Do. Angelica stem ...... Do. Angostura (cusparia bark) ...... Galipea officinalis Hancock. Anise ...... Pimpinella anisum L. Asafetida ...... Ferula assa-foetida L. and related spp. of Ferula. Balm (lemon balm) ...... Melissa officinalis L. Balsam of Peru ...... Myroxylon pereirae Klotzsch. Basil ...... Ocimum basilicum L. Bay leaves ...... Laurus nobilis L. Bay (myrcia oil) ...... Pimenta racemosa (Mill.) J. W. Moore. Bergamot (bergamot orange) ...... Citrus aurantium L. subsp. bergamia Wright et Arn. Bitter almond (free from prussic acid) ...... Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch. Bois de rose ...... Aniba rosaeodora Ducke. Cacao ...... Theobroma cacao L. Camomile (chamomile) flowers, Hungarian ...... Matricaria chamomilla L. Camomile (chamomile) flowers, Roman or English Anthemis nobilis L. Cananga ...... Cananga odorata Hook. f. and Thoms. Capsicum ...... Capsicum frutescens L. and Capsicum annuum L. Caraway ...... Carum carvi L. Cardamom seed (cardamon) ...... Elettaria cardamomum Maton. Carob bean ...... Ceratonia siliqua L. Carrot ...... Daucus carota L. Cascarilla bark ...... Croton eluteria Benn. Cassia bark, Chinese ...... Cinnamomum cassia Blume. Cassia bark, Padang or Batavia ...... Cinnamomum burmanni Blume. Cassia bark, Saigon ...... Cinnamomum loureirii Nees. Celery seed ...... Apium graveolens L. Cherry, wild, bark ...... Prunus serotina Ehrh. Chervil ...... Anthriscus cerefolium (L.) Hoffm. Chicory ...... Cichorium intybus L. Cinnamon bark, Ceylon ...... Cinnamomum zeylanicum Nees. Cinnamon bark, Chinese ...... Cinnamomum cassia Blume. Cinnamon bark, Saigon ...... Cinnamomum loureirii Nees. Cinnamon leaf, Ceylon ...... Cinnamomum zeylanicum Nees. Cinnamon leaf, Chinese ...... Cinnamomum cassia Blume. Cinnamon leaf, Saigon ...... Cinnamomum loureirii Nees. Citronella ...... nardus Rendle. Citrus peels ...... Citrus spp. Clary (clary sage) ...... Salvia sclarea L. Clover ...... Trifolium spp. (decocainized) ...... coca Lam. and other spp. of Erythroxylum.

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Common name Botanical name of plant source

Coffee ...... Coffea spp. Cola nut ...... Cola acuminata Schott and Endl., and other spp. of Cola. Coriander ...... Coriandrum sativum L. Cumin (cummin) ...... Cuminum cyminum L. Curacao orange peel (orange, bitter peel) ...... Citrus aurantium L. Cusparia bark ...... Galipea officinalis Hancock. Dandelion ...... Taraxacum officinale Weber and T. laevigatum DC. Dandelion root ...... Do. Dog grass (quackgrass, triticum) ...... Agropyron repens (L.) Beauv. Elder flowers ...... Sambucus canadensis L. and S. nigra I. Estragole (esdragol, esdragon, tarragon) ...... Artemisia dracunculus L. Estragon (tarragon) ...... Do. Fennel, sweet ...... Foeniculum vulgare Mill. Fenugreek ...... Trigonella foenum-graecum L. Galanga (galangal) ...... Alpinia officinarum Hance. Geranium ...... Pelargonium spp. Geranium, East Indian ...... Cymbopogon martini Stapf. Geranium, rose ...... Pelargonium graveolens L’Her. Ginger ...... Zingiber officinale Rosc. Grapefruit ...... Citrus paradisi Macf. Guava ...... Psidium spp. Hickory bark ...... Carya spp. Horehound (hoarhound) ...... Marrubium vulgare L. Hops ...... Humulus lupulus L. Horsemint ...... Monarda punctata L. Hyssop ...... Hyssopus officinalis L. Immortelle ...... Helichrysum augustifolium DC. Jasmine ...... Jasminum officinale L. and other spp. of Jasminum. Juniper (berries) ...... Juniperus communis L. Kola nut ...... Cola acuminata Schott and Endl., and other spp. of Cola. Laurel berries ...... Laurus nobilis L. Laurel leaves ...... Laurus spp. Lavender ...... Lavandula officinalis Chaix. Lavender, spike ...... Lavandula latifolia Vill. Lavandin ...... Hybrids between Lavandula officinalis Chaix and Lavandula latifolin Vill. Lemon ...... Citrus limon (L.) Burm. f. Lemon balm (see balm). Lemon grass ...... Cymbopogon citratus DC. and Cymbopogon lexuosus Stapf. Lemon peel ...... Citrus limon (L.) Burm. f. Lime ...... Citrus aurantifolia Swingle. Linden flowers ...... Tilia spp. Locust bean ...... Ceratonia siliqua L, Lupulin ...... Humulus lupulus L. Mace ...... Myristica fragrans Houtt. Mandarin ...... Citrus reticulata Blanco. Marjoram, sweet ...... Majorana hortensis Moench. Mate´ ...... Ilex paraguariensis St. Hil. Melissa (see balm). Menthol ...... Mentha spp. Menthyl acetate ...... Do. Molasses (extract) ...... Saccarum officinarum L. Mustard ...... Brassica spp. Naringin ...... Citrus paradisi Macf. Neroli, bigarade ...... Citrus aurantium L. Nutmeg ...... Myristica fragrans Houtt. Onion ...... Allium cepa L. Orange, bitter, flowers ...... Citrus aurantium L. Orange, bitter, peel ...... Do. Orange leaf ...... Citrus sinensis (L.) Osbeck. Orange, sweet ...... Do. Orange, sweet, flowers ...... Do. Orange, sweet, peel ...... Do. Origanum ...... Origanum spp. Palmarosa ...... Cymbopogon martini Stapf. Paprika ...... Capsicum annuum L. Parsley ...... Petroselinum crispum (Mill.) Mansf. Pepper, black ...... Piper nigrum L. Pepper, white ...... Do. Peppermint ...... Mentha piperita L. Peruvian balsam ...... Myroxylon pereirae Klotzsch. Petitgrain ...... Citrus aurantium L. Petitgrain lemon ...... Citrus limon (L.) Burm. f. Petitgrain mandarin or tangerine ...... Citrus reticulata Blanco. Pimenta ...... Pimenta officinalis Lindl.

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Common name Botanical name of plant source

Pimenta leaf ...... Pimenta officinalis Lindl. Pipsissewa leaves ...... Chimaphila umbellata Nutt. ...... Punica granatum L. Prickly ash bark ...... Xanthoxylum (or Zanthoxylum) Americanum Mill. or Xanthoxylum clava- herculis L. Rose absolute ...... Rosa alba L., Rosa centifolia L., Rosa damascena Mill., Rosa gallica L., and vars. of these spp. Rose (otto of roses, attar of roses) ...... Do. Rose buds ...... Do. Rose flowers ...... Do. Rose fruit (hips) ...... Do. Rose geranium ...... Pelargonium graveolens L’Her. Rose leaves ...... Rosa spp. Rosemary ...... Rosmarinus officinalis L. Saffron ...... Crocus sativus L. Sage ...... Salvia officinalis L. Sage, Greek ...... Salvia triloba L. Sage, Spanish ...... Salvia lavandulaefolia Vahl. St. John’s bread ...... Ceratonia siliqua L. Savory, summer ...... Satureia hortensis L. Savory, winter ...... Satureia montana L. ...... Schinus molle L. Sloe berries (blackthorn berries) ...... L. Spearmint ...... Mentha spicata L. Spike lavender ...... Lavandula latifolia Vill. ...... Tamarindus indica L. Tangerine ...... Citrus reticulata Blanco. Tarragon ...... Artemisia dracunculus L. Tea ...... Thea sinensis L. Thyme ...... Thymus vulgaris L. and Thymus zygis var. gracilis Boiss. Thyme, white ...... Do. Thyme, wild or creeping ...... Thymus serpyllum L. Triticum (see dog grass). Tuberose ...... Polianthes tuberosa L. Turmeric ...... Curcuma longa L. Vanilla ...... Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore. Violet flowers ...... Viola odorata L. Violet leaves ...... Do. Violet leaves absolute ...... Do. Wild cherry bark ...... Prunus serotina Ehrh. Ylang-ylang ...... Cananga odorata Hook. f. and Thoms. Zedoary bark ...... Curcuma zedoaria Rosc.

[42 FR 14640, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979; 47 FR 29953, July 9, 1982; 48 FR 51613, Nov. 10, 1983; 50 FR 21043 and 21044, May 22, 1985]

§ 182.40 Natural extractives (solvent- seasonings, and flavorings that are free) used in conjunction with generally recognized as safe for their spices, seasonings, and flavorings. intended use, within the meaning of Natural extractives (solvent-free) section 409 of the Act, are as follows: used in conjunction with spices,

Common name Botanical name of plant source

Apricot kernel (persic oil) ...... Prunus armeniaca L. Peach kernel (persic oil) ...... Prunus persica Sieb. et Zucc. Peanut stearine ...... Arachis hypogaea L. Persic oil (see apricot kernel and peach kernel). Quince seed ...... Cydonia oblonga Miller.

[42 FR 14640, Mar. 15, 1977, as amended at 47 FR 47375, Oct. 26, 1982]

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§ 182.50 Certain other spices, tracts that are generally recognized as seasonings, essential oils, safe for their intended use, within the oleoresins, and natural extracts. meaning of section 409 of the Act, are Certain other spices, seasonings, es- as follows: sential oils, oleoresins, and natural ex-

Common name Derivation

Ambergris ...... Physeter macrocephalus L. Castoreum ...... Castor fiber L. and C. canadensis Kuhl. Civet (zibeth, zibet, zibetum) ...... Civet cats, Viverra civetta Schreber and Viverra zibetha Schreber. Cognac oil, white and green ...... Ethyl oenanthate, so-called. Musk (Tonquin musk) ...... Musk deer, Moschus moschiferus L.

§ 182.60 Synthetic flavoring substances ognized as safe for their intended use, and adjuvants. within the meaning of section 409 of Synthetic flavoring substances and the Act, are as follows: adjuvants that are generally recog- Beef tallow. nized as safe for their intended use, Carboxymethylcellulose. within the meaning of section 409 of Coconut oil, refined. the Act, are as follows: Cornstarch. Gelatin. Acetaldehyde (ethanal). Lard. Acetoin (acetyl methylcarbinol). Lard oil. Anethole (parapropenyl anisole). Oleic acid. Benzaldehyde (benzoic aldehyde). Peanut oil. N-Butyric acid (butanoic acid). Potato starch. d- or l-Carvone (carvol). Sodium acetate. Cinnamaldehyde (cinnamic aldehyde). Sodium chloride. Citral (2,6-dimethyloctadien-2,6-al-8, gera- Sodium silicate. nial, neral). Sodium tripolyphosphate. Decanal (N-decylaldehyde, capraldehyde, Soybean oil (hydrogenated). capric aldehyde, caprinaldehyde, aldehyde Talc. C-10). Tallow (hydrogenated). Ethyl acetate. Tallow flakes. Ethyl butyrate. Tapioca starch. 3-Methyl-3-phenyl glycidic acid ethyl ester Tetrasodium pyrophosphate. (ethyl-methyl-phenyl-glycidate, so-called Wheat starch. strawberry aldehyde, C-16 aldehyde). Zinc chloride. Ethyl vanillin. [42 FR 14640, Mar. 15, 1977, as amended at 43 Geraniol (3,7-dimethyl-2,6 and 3,6-octadien-1- FR 11698, Mar. 21, 1978; 44 FR 28323, May 15, ol). 1979; 45 FR 6085, Jan. 25, 1980; 47 FR 27807, Geranyl acetate (geraniol acetate). 27814, June 25, 1982; 48 FR 51150, Nov. 7, 1983; Limonene (d-, l-, and dl-). 48 FR 51616, Nov. 10, 1983; 48 FR 51909, Nov. 15, Linalool (linalol, 3,7-dimethyl-1,6-octadien-3- 1983; 48 FR 52441, 52443, 52445, 52446, Nov. 18, ol). Linalyl acetate (bergamol). 1983; 51 FR 16830, May 7, 1986; 51 FR 27171, Methyl anthranilate (methyl-2- July 30, 1986; 60 FR 62208, Dec. 5, 1995] aminobenzoate). Piperonal (3,4-methylenedioxy-benzaldehyde, § 182.90 Substances migrating to food heliotropin). from paper and paperboard prod- Vanillin. ucts. [42 FR 14640, Mar. 15, 1977, as amended at 43 Substances migrating to food from FR 47724, Oct. 17, 1978; 44 FR 3963, Jan. 19, paper and paperboard products used in 1979; 44 FR 20656, Apr. 6, 1979; 48 FR 51907, food packaging that are generally rec- Nov. 15, 1983; 54 FR 7402, Feb. 21, 1989] ognized as safe for their intended use, within the meaning of section 409 of § 182.70 Substances migrating from the Act, are as follows: cotton and cotton fabrics used in dry food packaging. Alum (double sulfate of aluminum and am- monium potassium, or sodium). Substances migrating to food from Aluminum hydroxide. cotton and cotton fabrics used in dry Aluminum oleate. food packaging that are generally rec- Aluminum palmitate.

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Casein. (c) Limitations, restrictions, or expla- Cellulose acetate. nation. This substance is generally rec- Cornstarch. ognized as safe when used as a salt sub- Diatomaceous earth filler. Ethyl cellulose. stitute in accordance with good manu- Ethyl vanillin. facturing practice. Glycerin. Oleic acid. § 182.1057 Hydrochloric acid. Potassium sorbate. (a) Product. Hydrochloric acid. Silicon dioxides. Sodium aluminate. (b) [Reserved] Sodium chloride. (c) Limitations, restrictions, or expla- Sodium hexametaphosphate. nation. This substance is generally rec- Sodium hydrosulfite. ognized as safe when used as a buffer Sodium phosphoaluminate. and neutralizing agent in accordance Sodium silicate. with good manufacturing practice. Sodium sorbate. Sodium tripolyphosphate. § 182.1073 Phosphoric acid. Sorbitol. Soy protein, isolated. (a) Product. Phosphoric acid. Starch, acid modified. (b) Conditions of use. This substance Starch, pregelatinized. is generally recognized as safe when Starch, unmodified. used in accordance with good manufac- Talc. Vanillin. turing practice. Zinc hydrosulfite. Zinc sulfate. § 182.1087 Sodium acid pyrophosphate. [42 FR 14640, Mar. 15, 1977] (a) Product. Sodium acid pyrophosphate. EDITORIAL NOTE: For additional FEDERAL (b) Conditions of use. This substance REGISTER citations affecting § 182.90, see the List of CFR Sections Affected, which appears is generally recognized as safe when in the Finding Aids section of the printed used in accordance with good manufac- volume and on GPO Access. turing practice.

§ 182.99 Adjuvants for pesticide chemi- § 182.1125 Aluminum sulfate. cals. (a) Product. Aluminum sulfate. Adjuvants, identified and used in ac- (b) Conditions of use. This substance cordance with 40 CFR 180.1001 (c) and is generally recognized as safe when (d), which are added to pesticide use di- used in accordance with good manufac- lutions by a grower or applicator prior turing practice. to application to the raw agricultural commodity, are exempt from the re- § 182.1127 Aluminum ammonium sul- quirement of tolerances under section fate. 409 of the Act. (a) Product. Aluminum . Subpart B—Multiple Purpose GRAS (b) Conditions of use. This substance Food Substances is generally recognized as safe when used in accordance with good manufac- § 182.1045 Glutamic acid. turing practice. (a) Product. Glutamic acid. (b) [Reserved] § 182.1129 Aluminum potassium sul- fate. (c) Limitations, restrictions, or expla- nation. This substance is generally rec- (a) Product. Aluminum potassium sul- ognized as safe when used as a salt sub- fate. stitute in accordance with good manu- (b) Conditions of use. This substance facturing practice. is generally recognized as safe when used in accordance with good manufac- § 182.1047 Glutamic acid hydro- turing practice. chloride. (a) Product. Glutamic acid hydro- § 182.1131 Aluminum sodium sulfate. chloride. (a) Product. Aluminum sodium sul- (b) [Reserved] fate.

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(b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice.

§ 182.1180 Caffeine. § 182.1711 Silica aerogel. (a) Product. Caffeine. (a) Product. Silica aerogel as a finely (b) Tolerance. 0.02 percent. powdered microcellular silica foam (c) Limitations, restrictions, or expla- having a minimum silica content of nation. This substance is generally rec- 89.5 percent. ognized as safe when used in cola-type (b) [Reserved] beverages in accordance with good (c) Limitations, restrictions, or expla- manufacturing practice. nation. This substance is generally rec- ognized as safe when used as a compo- § 182.1217 Calcium phosphate. nent of an anti-foaming agent in ac- (a) Product. Calcium phosphate cordance with good manufacturing (mono-, di-, and tribasic). practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.1745 Sodium carboxymethylcellu- used in accordance with good manufac- lose. turing practice. (a) Product. Sodium carboxy- methylcellulose is the sodium salt of § 182.1235 Caramel. carboxymethylcellulose not less than (a) Product. Caramel. 99.5 percent on a dry-weight basis, with (b) Conditions of use. This substance maximum substitution of 0.95 is generally recognized as safe when carboxymethyl groups per used in accordance with good manufac- anhydroglucose unit, and with a min- turing practice. imum viscosity of 25 centipoises for 2 percent by weight aqueous solution at § 182.1320 Glycerin. 25 °C. (a) Product. Glycerin. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.1748 Sodium caseinate. § 182.1480 Methylcellulose. (a) Product. Sodium caseinate. (a) Product. U.S.P. methylcellulose, (b) Conditions of use. This substance except that the methoxy content shall is generally recognized as safe when not be less than 27.5 percent and not used in accordance with good manufac- more than 31.5 percent on a dry-weight turing practice. basis. (b) Conditions of use. This substance § 182.1778 Sodium phosphate. is generally recognized as safe when (a) Product. Sodium phosphate used in accordance with good manufac- (mono-, di-, and tribasic). turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.1500 Monoammonium glutamate. used in accordance with good manufac- (a) Product. Monoammonium glu- turing practice. tamate. (b) Conditions of use. This substance § 182.1781 Sodium aluminum phos- is generally recognized as safe when phate. used in accordance with good manufac- (a) Product. Sodium aluminum phos- turing practice. phate. (b) Conditions of use. This substance § 182.1516 Monopotassium glutamate. is generally recognized as safe when (a) Product. Monopotassium glu- used in accordance with good manufac- tamate. turing practice.

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§ 182.1810 Sodium tripolyphosphate. § 182.2906 Tricalcium silicate. (a) Product. Sodium (a) Product. Tricalcium silicate. tripolyphosphate. (b) Tolerance. 2 percent. (b) Conditions of use. This substance (c) Limitations, restrictions, or expla- is generally recognized as safe when nation. This substance is generally rec- used in accordance with good manufac- ognized as safe when used in table salt turing practice. in accordance with good manufacturing practice. Subpart C—Anticaking Agents Subpart D—Chemical § 182.2122 Aluminum calcium silicate. Preservatives (a) Product. Aluminum calcium sili- cate. § 182.3013 Ascorbic acid. (b) Tolerance. 2 percent. (a) Product. Ascorbic acid. (c) Limitations, restrictions, or expla- (b) Conditions of use. This substance nation. This substance is generally rec- is generally recognized as safe when ognized as safe when used in table salt used in accordance with good manufac- in accordance with good manufacturing turing practice. practice. § 182.3041 Erythorbic acid. § 182.2227 Calcium silicate. (a) Product. Erythorbic acid. (a) Product. Calcium silicate. (b) Conditions of use. This substance (b) Tolerance. 2 percent and 5 percent. is generally recognized as safe when (c) Limitations, restrictions, or expla- used in accordance with good manufac- nation. This substance is generally rec- turing practice. ognized as safe when used at levels not exceeding 2 percent in table salt and 5 § 182.3089 Sorbic acid. percent in baking powder in accordance (a) Product. Sorbic acid. with good manufacturing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.2437 Magnesium silicate. used in accordance with good manufac- (a) Product. Magnesium silicate. turing practice. (b) Tolerance. 2 percent. (c) Limitations, restrictions, or expla- § 182.3109 Thiodipropionic acid. nation. This substance is generally rec- (a) Product. Thiodipropionic acid. ognized as safe when used in table salt (b) Tolerance. This substance is gen- in accordance with good manufacturing erally recognized as safe for use in food practice. when the total content of antioxidants is not over 0.02 percent of fat or oil § 182.2727 Sodium aluminosilicate. content, including essential (volatile) (a) Product. Sodium aluminosilicate oil content of the food, provided the (sodium silicoaluminate). substance is used in accordance with (b) Tolerance. This substance is gen- good manufacturing practice. erally recognized as safe for use at a level not exceeding 2 percent in accord- § 182.3149 Ascorbyl palmitate. ance with good manufacturing prac- (a) Product. Ascorbyl palmitate. tice. (b) Conditions of use. This substance is generally recognized as safe when § 182.2729 Sodium calcium used in accordance with good manufac- aluminosilicate, hydrated. turing practice. (a) Product. Hydrated sodium calcium aluminosilicate (sodium calcium § 182.3169 Butylated hydroxyanisole. silicoaluminate). (a) Product. Butylated hydroxy- (b) Tolerance. This substance is gen- anisole. erally recognized as safe for use at a (b) Tolerance. This substance is gen- level not exceeding 2 percent in accord- erally recognized as safe for use in food ance with good manufacturing prac- when the total content of antioxidants tice. is not over 0.02 percent of fat or oil

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content, including essential (volatile) § 182.3637 Potassium metabisulfite. oil content of food, provided the sub- (a) Product. Potassium metabisulfite. stance is used in accordance with good manufacturing practice. (b) [Reserved] (c) Limitations, restrictions, or expla- § 182.3173 Butylated hydroxytoluene. nation. This substance is generally rec- ognized as safe when used in accord- (a) Product. Butylated hydroxy- toluene. ance with good manufacturing prac- (b) Tolerance. This substance is gen- tice, except that it is not used in erally recognized as safe for use in food meats; in food recognized as a source of when the total content of antioxidants vitamin B1; on fruits and vegetables in- is not over 0.02 percent of fat or oil tended to be served raw to consumers content, including essential (volatile) or sold raw to consumers, or to be pre- oil content of food, provided the sub- sented to consumers as fresh. stance is used in accordance with good [42 FR 14640, Mar. 15, 1977, as amended at 51 manufacturing practice. FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994] § 182.3189 Calcium ascorbate. (a) Product. Calcium ascorbate. § 182.3640 Potassium sorbate. (b) Conditions of use. This substance (a) Product. Potassium sorbate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.3225 Calcium sorbate. (a) Product. Calcium sorbate. § 182.3731 Sodium ascorbate. (b) Conditions of use. This substance (a) Product. Sodium ascorbate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.3280 Dilauryl thiodipropionate. (a) Product. Dilauryl § 182.3739 Sodium bisulfite. thiodipropionate. (a) Product. Sodium bisulfite. (b) Tolerance. This substance is gen- (b) [Reserved] erally recognized as safe for use in food (c) Limitations, restrictions, or expla- when the total content of antioxidants is not over 0.02 percent of fat or oil nation. This substance is generally rec- content, including essential (volatile) ognized as safe when used in accord- oil content of the food, provided the ance with good manufacturing prac- substance is used in accordance with tice, except that it is not used in good manufacturing practice. meats; in food recognized as a source of vitamin B1; on fruits or vegetables in- § 182.3616 Potassium bisulfite. tended to be served raw to consumers or sold raw to consumers, or to be pre- (a) Product. Potassium bisulfite. (b) [Reserved] sented to the consumer as fresh. (c) Limitations, restrictions, or expla- [42 FR 14640, Mar. 15, 1977, as amended at 51 nation. This substance is generally rec- FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, ognized as safe when used in accord- 1990; 59 FR 65939, Dec. 22, 1994] ance with good manufacturing prac- tice, except that it is not used in § 182.3766 Sodium metabisulfite. meats; in food recognized as a source of (a) Product. Sodium metabisulfite. vitamin B1; on fruits and vegetables in- (b) [Reserved] tended to be served raw to consumers (c) Limitations, restrictions, or expla- or sold raw to consumers, or to be pre- nation. This substance is generally rec- sented to consumers as fresh. ognized as safe when used in accord- [42 FR 14640, Mar. 15, 1977, as amended at 51 ance with good manufacturing prac- FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, tice, except that it is not used in 1990; 59 FR 65939, Dec. 22, 1994] meats; in food recognized as a source of

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vitamin B1; on fruits or vegetables in- Subpart F—Dietary Supplements tended to be served raw to consumers [Reserved] or sold raw to consumers, or to be pre- sented to consumers as fresh. Subpart G—Sequestrants 1 [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9833, Mar. 15, § 182.6085 Sodium acid phosphate. 1990; 59 FR 65939, Dec. 22, 1994] (a) Product. Sodium acid phosphate. § 182.3795 Sodium sorbate. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Sodium sorbate. used in accordance with good manufac- (b) Conditions of use. This substance turing practice. is generally recognized as safe when used in accordance with good manufac- § 182.6197 Calcium diacetate. turing practice. (a) Product. Calcium diacetate. § 182.3798 Sodium sulfite. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Sodium sulfite. used in accordance with good manufac- (b) [Reserved] turing practice. (c) Limitations, restrictions, or expla- nation. This substance is generally rec- § 182.6203 Calcium ognized as safe when used in accord- hexametaphosphate. ance with good manufacturing prac- (a) Calcium tice, except that it is not used in Product. hexametaphosphate. meats; in food recognized as a source of (b) Conditions of use. This substance vitamin B1; on fruits or vegetables in- tended to be served raw to consumers is generally recognized as safe when or sold raw to consumers, or to be pre- used in accordance with good manufac- sented to consumers as fresh. turing practice. [42 FR 14640, Mar. 15, 1977, as amended at 51 § 182.6215 Monobasic calcium phos- FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, phate. 1990; 59 FR 65939, Dec. 22, 1994] (a) Product. Monobasic calcium phos- phate. § 182.3862 Sulfur dioxide. (b) Conditions of use. This substance (a) Product. Sulfur dioxide. is generally recognized as safe when (b) [Reserved] used in accordance with good manufac- (c) Limitations, restrictions, or expla- turing practice. nation. This substance is generally rec- ognized as safe when used in accord- § 182.6285 Dipotassium phosphate. ance with good manufacturing prac- (a) Product. Dipotassium phosphate. tice, except that it is not used in (b) Conditions of use. This substance meats; in food recognized as a source of is generally recognized as safe when vitamin B ; on fruits or vegetables in- 1 used in accordance with good manufac- tended to be served raw to consumers turing practice. or sold raw to consumers, or to be pre- sented to consumers as fresh. § 182.6290 Disodium phosphate. [42 FR 14640, Mar. 15, 1977, as amended at 51 (a) Product. Disodium phosphate. FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, (b) Conditions of use. This substance 1990; 59 FR 65939, Dec. 22, 1994] is generally recognized as safe when used in accordance with good manufac- § 182.3890 Tocopherols. turing practice. (a) Product. Tocopherols. (b) Conditions of use. This substance § 182.6757 Sodium gluconate. is generally recognized as safe when (a) Product. Sodium gluconate. used in accordance with good manufac- turing practice. 1 For the purpose of this subpart, no at- tempt has been made to designate those Subpart E—Emulsifying Agents sequestrants that may also function as [Reserved] chemical preservatives. 477

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(b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice.

§ 182.6760 Sodium Subpart I—Nutrients hexametaphosphate. (a) Product. Sodium SOURCE: 45 FR 58838, Sept. 5, 1980, unless hexametaphosphate. otherwise noted. (b) Conditions of use. This substance is generally recognized as safe when § 182.8013 Ascorbic acid. used in accordance with good manufac- (a) Product. Ascorbic acid. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.6769 Sodium metaphosphate. used in accordance with good manufac- (a) Product. Sodium metaphosphate. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.8159 Biotin. used in accordance with good manufac- (a) Product. Biotin. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.6778 Sodium phosphate. used in accordance with good manufac- (a) Product. Sodium phosphate turing practice. (mono-, di-, and tribasic). (b) Conditions of use. This substance § 182.8217 Calcium phosphate. is generally recognized as safe when (a) Product. Calcium phosphate used in accordance with good manufac- (mono-, di-, and tribasic). turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.6787 Sodium pyrophosphate. used in accordance with good manufac- (a) Product. Sodium pyrophosphate. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.8223 Calcium pyrophosphate. used in accordance with good manufac- (a) Product. Calcium pyrophosphate. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.6789 Tetra sodium used in accordance with good manufac- pyrophosphate. turing practice. (a) Product. Tetra sodium pyrophosphate. § 182.8250 Choline bitartrate. (b) Conditions of use. This substance (a) Product. Choline bitartrate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.6810 Sodium tripolyphosphate. (a) Product. Sodium § 182.8252 Choline chloride. tripolyphosphate. (a) Product. Choline chloride. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice.

Subpart H—Stabilizers § 182.8778 Sodium phosphate. (a) Product. Sodium phosphate § 182.7255 Chondrus extract. (mono-, di-, and tribasic). (a) Product. Chondrus extract (b) Conditions of use. This substance (carrageenin). is generally recognized as safe when

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used in accordance with good manufac- PART 184—DIRECT FOOD SUB- turing practice. STANCES AFFIRMED AS GEN- § 182.8890 Tocopherols. ERALLY RECOGNIZED AS SAFE (a) Product. Tocopherols. Subpart A—General Provisions (b) Conditions of use. This substance Sec. is generally recognized as safe when 184.1 Substances added directly to human used in accordance with good manufac- food affirmed as generally recognized as turing practice. safe (GRAS).

§ 182.8892 ù-Tocopherol acetate. Subpart B—Listing of Specific Substances Affirmed as GRAS (a) Product. a-Tocopherol acetate. (b) Conditions of use. This substance 184.1005 Acetic acid. is generally recognized as safe when 184.1007 Aconitic acid. used in accordance with good manufac- 184.1009 Adipic acid. 184.1011 Alginic acid. turing practice. 184.1012 a-Amylase enzyme preparation from Bacillus stearothermophilus. § 182.8985 Zinc chloride. 184.1021 Benzoic acid. (a) Product. Zinc chloride. 184.1024 Bromelain. (b) Conditions of use. This substance 184.1025 Caprylic acid. 184.1027 Mixed carbohydrase and protease is generally recognized as safe when enzyme product. used in accordance with good manufac- 184.1033 Citric acid. turing practice. 184.1034 Catalase (bovine liver). 184.1061 Lactic acid. § 182.8988 Zinc gluconate. 184.1063 Enzyme-modified lecithin. 184.1065 Linoleic acid. (a) Product. Zinc gluconate. 184.1069 Malic acid. (b) Conditions of use. This substance 184.1077 Potassium acid tartrate. is generally recognized as safe when 184.1081 Propionic acid. used in accordance with good manufac- 184.1090 Stearic acid. 184.1091 Succinic acid. turing practice. 184.1095 Sulfuric acid. 184.1097 Tannic acid. § 182.8991 Zinc oxide. 184.1099 Tartaric acid. (a) Product. Zinc oxide. 184.1101 Diacetyl tartaric acid esters of mono- and diglycerides. (b) Conditions of use. This substance 184.1115 Agar-agar. is generally recognized as safe when 184.1120 Brown algae. used in accordance with good manufac- 184.1121 Red algae. turing practice. 184.1133 Ammonium alginate. 184.1135 . § 182.8994 Zinc stearate. 184.1137 . 184.1138 . (a) Product. Zinc stearate prepared 184.1139 Ammonium hydroxide. from stearic acid free from chickedema 184.1140 Ammonium citrate, dibasic. factor. 184.1141a , monobasic. (b) Conditions of use. This substance 184.1141b Ammonium phosphate, dibasic. 184.1143 Ammonium sulfate. is generally recognized as safe when 184.1148 Bacterially-derived carbohydrase used in accordance with good manufac- enzyme preparation. turing practice. 184.1150 Bacterially-derived protease en- zyme preparation. § 182.8997 Zinc sulfate. 184.1155 Bentonite. 184.1157 Benzoyl peroxide. (a) Product. Zinc sulfate. 184.1165 n-Butane and iso-butane. (b) Conditions of use. This substance 184.1185 Calcium acetate. is generally recognized as safe when 184.1187 Calcium alginate. used in accordance with good manufac- 184.1191 Calcium carbonate. turing practice. 184.1193 Calcium chloride. 184.1195 Calcium citrate. 184.1199 Calcium gluconate. 184.1201 Calcium glycerophosphate.

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