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§ 182.1 21 CFR Ch. I (4–1–08 Edition)

Subpart A—General Provisions Commissioner will offer an opinion, based on specifications and intended § 182.1 Substances that are generally use, as to whether or not a particular recognized as safe. grade or lot of the substance is of suit- (a) It is impracticable to list all sub- able purity for use in food and would stances that are generally recognized generally be regarded as safe for the as safe for their intended use. However, purpose intended, by experts qualified by way of illustration, the Commis- to evaluate its safety. sioner regards such common food in- (c) The inclusion of substances in the gredients as , pepper, vinegar, bak- list of nutrients does not constitute a ing powder, and monosodium glu- finding on the part of the Department tamate as safe for their intended use. that the substance is useful as a sup- This part includes additional sub- plement to the diet for humans. stances that, when used for the pur- (d) Substances that are generally rec- poses indicated, in accordance with ognized as safe for their intended use good manufacturing practice, are re- within the meaning of section 409 of garded by the Commissioner as the act are listed in this part. When generaly recognized as safe for such the status of a substance has been re- uses. evaluated, it will be deleted from this (b) For the purposes of this section, part, and will be issued as a new regu- good manufacturing practice shall be lation under the appropriate part, e.g., defined to include the following re- ‘‘affirmed as GRAS’’ under part 184 or strictions: 186 of this chapter; ‘‘food additive regu- (1) The quantity of a substance added lation’’ under parts 170 through 180 of to food does not exceed the amount this chapter; ‘‘interim food additive reasonably required to accomplish its regulation’’ under part 180 of this chap- intended physical, nutritional, or other ter; or ‘‘prohibited from use in food’’ technical effect in food; and under part 189 of this chapter. (2) The quantity of a substance that becomes a component of food as a re- [42 FR 14640, Mar. 15, 1977, as amended at 53 sult of its use in the manufacturing, FR 44875, Nov. 7, 1988] processing, or packaging of food, and which is not intended to accomplish § 182.10 and other natural any physical or other technical effect and flavorings. in the food itself, shall be reduced to Spices and other natural seasonings the extent reasonably possible. and flavorings that are generally rec- (3) The substance is of appropriate ognized as safe for their intended use, food grade and is prepared and handled within the meaning of section 409 of as a food ingredient. Upon request the the Act, are as follows:

Common name Botanical name of plant 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.

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Common name Botanical name of plant source

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. (). 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]

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§ 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. Coca (decocainized) ...... Erythroxylum coca Lam. and other spp. of Erythroxylum. 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.

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Common name Botanical name of plant source

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. 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.

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Common name Botanical name of plant source

Savory, summer ...... Satureia hortensis L. Savory, winter ...... Satureia montana L. ...... Schinus molle L. Sloe berries (blackthorn berries) ...... Prunus spinosa 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]

§ 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 nized 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- Acetaldehyde (ethanal).

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Acetoin (acetyl methylcarbinol). Zinc chloride. Anethole (parapropenyl anisole). [42 FR 14640, Mar. 15, 1977, as amended at 43 Benzaldehyde (benzoic aldehyde). FR 11698, Mar. 21, 1978; 44 FR 28323, May 15, N-Butyric acid (butanoic acid). 1979; 45 FR 6085, Jan. 25, 1980; 47 FR 27807, d- or l-Carvone (carvol). 27814, June 25, 1982; 48 FR 51150, Nov. 7, 1983; Cinnamaldehyde (cinnamic aldehyde). 48 FR 51616, Nov. 10, 1983; 48 FR 51909, Nov. 15, Citral (2,6-dimethyloctadien-2,6-al-8, gera- 1983; 48 FR 52441, 52443, 52445, 52446, Nov. 18, nial, neral). 1983; 51 FR 16830, May 7, 1986; 51 FR 27171, Decanal ( -decylaldehyde, capraldehyde, N July 30, 1986; 60 FR 62208, Dec. 5, 1995] capric aldehyde, caprinaldehyde, aldehyde C-10). § 182.90 Substances migrating to food Ethyl acetate. from paper and paperboard prod- Ethyl butyrate. ucts. 3-Methyl-3-phenyl glycidic acid ethyl ester (ethyl-methyl-phenyl-glycidate, so-called Substances migrating to food from strawberry aldehyde, C-16 aldehyde). paper and paperboard products used in Ethyl vanillin. food packaging that are generally rec- Geraniol (3,7-dimethyl-2,6 and 3,6-octadien-1- ognized as safe for their intended use, ol). within the meaning of section 409 of Geranyl acetate (geraniol acetate). Limonene (d-, l-, and dl-). the Act, are as follows: Linalool (linalol, 3,7-dimethyl-1,6-octadien-3- Alum (double sulfate of aluminum and am- ol). monium potassium, or sodium). Linalyl acetate (bergamol). Aluminum hydroxide. Methyl anthranilate (methyl-2- Aluminum oleate. aminobenzoate). Aluminum palmitate. Piperonal (3,4-methylenedioxy-benzaldehyde, Casein. heliotropin). Cellulose acetate. Vanillin. Cornstarch. [42 FR 14640, Mar. 15, 1977, as amended at 43 Diatomaceous earth filler. FR 47724, Oct. 17, 1978; 44 FR 3963, Jan. 19, Ethyl cellulose. 1979; 44 FR 20656, Apr. 6, 1979; 48 FR 51907, Ethyl vanillin. Nov. 15, 1983; 54 FR 7402, Feb. 21, 1989] Glycerin. Oleic acid. § 182.70 Substances migrating from Potassium sorbate. cotton and cotton fabrics used in Silicon dioxides. dry food packaging. Sodium aluminate. Sodium chloride. Substances migrating to food from Sodium hexametaphosphate. cotton and cotton fabrics used in dry Sodium hydrosulfite. food packaging that are generally rec- Sodium phosphoaluminate. ognized as safe for their intended use, Sodium silicate. within the meaning of section 409 of Sodium sorbate. the Act, are as follows: Sodium tripolyphosphate. Sorbitol. Beef tallow. Soy protein, isolated. Carboxymethylcellulose. Starch, acid modified. Coconut oil, refined. Starch, pregelatinized. Cornstarch. Starch, unmodified. Gelatin. Talc. Lard. Vanillin. Lard oil. Zinc hydrosulfite. Oleic acid. Zinc sulfate. Peanut oil. Potato starch. [42 FR 14640, Mar. 15, 1977] Sodium acetate. EDITORIAL NOTE: For additional FEDERAL Sodium chloride. REGISTER citations affecting § 182.90, see the Sodium silicate. List of CFR Sections Affected, which appears Sodium tripolyphosphate. in the Finding Aids section of the printed Soybean oil (hydrogenated). volume and on GPO Access. Talc. Tallow (hydrogenated). § 182.99 Adjuvants for pesticide chemi- Tallow flakes. cals. Tapioca starch. Tetrasodium pyrophosphate. Adjuvants, identified and used in ac- Wheat starch. cordance with 40 CFR 180.1001 (c) and

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(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 ammonium sulfate. 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. § 182.1129 Aluminum potassium sul- (b) [Reserved] fate. (c) Limitations, restrictions, or expla- (a) Product. Aluminum potassium sul- nation. This substance is generally rec- fate. ognized as safe when used as a salt sub- (b) Conditions of use. This substance stitute in accordance with good manu- is generally recognized as safe when facturing practice. used in accordance with good manufac- turing practice. § 182.1047 Glutamic acid hydro- chloride. § 182.1131 Aluminum sodium sulfate. (a) Product. Glutamic acid hydro- (a) Product. Aluminum sodium sul- chloride. fate. (b) [Reserved] (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 as a salt sub- turing practice. stitute in accordance with good manu- facturing practice. § 182.1180 Caffeine. (a) Product. Caffeine. § 182.1057 Hydrochloric acid. (b) Tolerance. 0.02 percent. (a) Product. Hydrochloric acid. (c) Limitations, restrictions, or expla- (b) [Reserved] nation. This substance is generally rec- (c) Limitations, restrictions, or expla- ognized as safe when used in cola-type nation. This substance is generally rec- beverages in accordance with good ognized as safe when used as a buffer manufacturing practice. and neutralizing agent in accordance with good manufacturing practice. § 182.1217 Calcium phosphate. (a) Product. Calcium phosphate § 182.1073 Phosphoric acid. (mono-, di-, and tribasic). (a) Product. Phosphoric acid. (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. § 182.1235 Caramel. § 182.1087 Sodium acid pyrophosphate. (a) Product. Caramel. (a) Product. Sodium acid (b) Conditions of use. This substance pyrophosphate. 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. § 182.1320 Glycerin. (a) Product. Glycerin. § 182.1125 Aluminum sulfate. (b) Conditions of use. This substance (a) Product. Aluminum sulfate. 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.

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