Substances generally recognized as safe (21 CFR 182.1-182.8997)

475 Food and Drug Administration, HHS Pt. 182 200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (1) In the case of single-use articles having a volume to surface ratio of 10 milliliters or more per square inch of food-contact surface—0.003 milligram/ square inch when extracted to equi librium at 120 °F with food-simulating solvents appropriate to the intended conditions of use. (2) In the case of single-use articles having a volume to surface ratio of less than 10 milliliters per square inch of food-contact surface—0.3 part per mil lion calculated on the basis of the vol ume of the container when extracted to equilibrium at 120 °F with food-simu lating solvents appropriate to the in tended conditions of use. (3) In the case of repeated-use arti cles—0.003 milligram/square inch when extracted at a time equivalent to ini tial batch usage utilizing food-simu lating solvents and temperatures ap propriate to the intended conditions of use. The food-simulating solvents shall in clude, where applicable, distilled water, 8 percent or 50 percent ethanol, 3 percent acetic acid, and either n heptane or an appropriate oil or fat. (c) Acrylonitrile monomer may present a hazard to health when in gested. Accordingly, any food-contact article containing acrylonitrile copoly mers or resins that yield acrylonitrile monomer in excess of that amount pro vided for in paragraph (b) of this sec tion shall be deemed to be adulterated in violation of section 402 of the Act. [42 FR 14638, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, 1989] § 181.33 Sodium nitrate and potassium nitrate. Sodium nitrate and potassium ni trate are subject to prior sanctions issued by the U.S. Department of Agri culture for use as sources of nitrite, with or without sodium or potassium nitrite, in the production of cured red meat products and cured poultry prod ucts. [48 FR 1705, Jan. 14, 1983] § 181.34 Sodium nitrite and potassium nitrite. Sodium nitrite and potassium nitrite are subject to prior sanctions issued by the U.S. Department of Agriculture for use as color fixatives and preservative agents, with or without sodium or po tassium nitrate, in the curing of red meat and poultry products. [48 FR 1705, Jan. 14, 1983] PART 182—SUBSTANCES GENERALLY RECOGNIZED AS SAFE Subpart A—General Provisions Sec. 182.1 Substances that are generally recog nized as safe. 182.10 Spices and other natural seasonings and flavorings. 182.20 Essential oils, oleoresins (solvent free), and natural extractives (including distillates). 182.40 Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings. 182.50 Certain other spices, seasonings, es sential oils, oleoresins, and natural ex tracts. 182.60 Synthetic flavoring substances and adjuvants. 182.70 Substances migrating from cotton and cotton fabrics used in dry food pack aging. 182.90 Substances migrating to food from paper and paperboard products. 182.99 Adjuvants for pesticide chemicals. Subpart B—Multiple Purpose GRAS Food Substances 182.1045 Glutamic acid. 182.1047 Glutamic acid hydrochloride. 182.1057 Hydrochloric acid. 182.1073 Phosphoric acid. 182.1087 Sodium acid pyrophosphate. 182.1125 Aluminum sulfate. 182.1127 Aluminum ammonium sulfate. 182.1129 Aluminum potassium sulfate. 182.1131 Aluminum sodium sulfate. 182.1180 Caffeine. 182.1217 Calcium phosphate. 182.1235 Caramel. 182.1320 Glycerin. 182.1480 Methylcellulose. 182.1500 Monoammonium glutamate. 182.1516 Monopotassium glutamate. VerDate Sep<11>2014 11:23 Apr 30, 2018 Jkt 244072 PO 00000 Frm 00485 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 476 21 CFR Ch. I (4–1–18 Edition) § 182.1 182.1711 Silica aerogel. 182.1745 Sodium carboxymethylcellulose. 182.1748 Sodium caseinate. 182.1778 Sodium phosphate. 182.1781 Sodium aluminum phosphate. 182.1810 Sodium tripolyphosphate. Subpart C—Anticaking Agents 182.2122 Aluminum calcium silicate. 182.2227 Calcium silicate. 182.2437 Magnesium silicate. 182.2727 Sodium aluminosilicate. 182.2729 Sodium calcium aluminosilicate, hydrated. 182.2906 Tricalcium silicate. Subpart D—Chemical Preservatives 182.3013 Ascorbic acid. 182.3041 Erythorbic acid. 182.3089 Sorbic acid. 182.3109 Thiodipropionic acid. 182.3149 Ascorbyl palmitate. 182.3169 Butylated hydroxyanisole. 182.3173 Butylated hydroxytoluene. 182.3189 Calcium ascorbate. 182.3225 Calcium sorbate. 182.3280 Dilauryl thiodipropionate. 182.3616 Potassium bisulfite. 182.3637 Potassium metabisulfite. 182.3640 Potassium sorbate. 182.3731 Sodium ascorbate. 182.3739 Sodium bisulfite. 182.3766 Sodium metabisulfite. 182.3795 Sodium sorbate. 182.3798 Sodium sulfite. 182.3862 Sulfur dioxide. 182.3890 Tocopherols. Subpart E—Emulsifying Agents [Reserved] Subpart F—Dietary Supplements [Reserved] Subpart G—Sequestrants 182.6085 Sodium acid phosphate. 182.6197 Calcium diacetate. 182.6203 Calcium hexametaphosphate. 182.6215 Monobasic calcium phosphate. 182.6285 Dipotassium phosphate. 182.6290 Disodium phosphate. 182.6757 Sodium gluconate. 182.6760 Sodium hexametaphosphate. 182.6769 Sodium metaphosphate. 182.6778 Sodium phosphate. 182.6787 Sodium pyrophosphate. 182.6789 Tetra sodium pyrophosphate. 182.6810 Sodium tripolyphosphate. Subpart H—Stabilizers 182.7255 Chondrus extract. Subpart I—Nutrients 182.8013 Ascorbic acid. 182.8159 Biotin. 182.8217 Calcium phosphate. 182.8223 Calcium pyrophosphate. 182.8250 Choline bitartrate. 182.8252 Choline chloride. 182.8778 Sodium phosphate. 182.8890 Tocopherols. 182.8892 a-Tocopherol acetate. 182.8985 Zinc chloride. 182.8988 Zinc gluconate. 182.8991 Zinc oxide. 182.8994 Zinc stearate. 182.8997 Zinc sulfate. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. SOURCE: 42 FR 14640, Mar. 15, 1977, unless otherwise noted. Subpart A—General Provisions § 182.1 Substances that are generally recognized as safe. (a) It is impracticable to list all sub stances that are generally recognized as safe for their intended use. However, by way of illustration, the Commis sioner regards such common food in gredients as salt, pepper, vinegar, bak ing powder, and monosodium glu tamate as safe for their intended use. This part includes additional sub stances that, when used for the pur poses indicated, in accordance with good manufacturing practice, are re garded by the Commissioner as generaly recognized as safe for such uses. (b) For the purposes of this section, good manufacturing practice shall be defined to include the following re strictions: (1) The quantity of a substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritional, or other technical effect in food; and (2) The quantity of a substance that becomes a component of food as a re sult of its use in the manufacturing, processing, or packaging of food, and which is not intended to accomplish any physical or other technical effect in the food itself, shall be reduced to the extent reasonably possible. (3) The substance is of appropriate food grade and is prepared and handled as a food ingredient. Upon request the Commissioner will offer an opinion, based on specifications and intended use, as to whether or not a particular VerDate Sep<11>2014 11:23 Apr 30, 2018 Jkt 244072 PO 00000 Frm 00486 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 477 Food and Drug Administration, HHS § 182.10 grade or lot of the substance is of suit able purity for use in food and would generally be regarded as safe for the purpose intended, by experts qualified to evaluate its safety. (c) The inclusion of substances in the list of nutrients does not constitute a finding on the part of the Department that the substance is useful as a sup plement to the diet for humans. (d) Substances that are generally rec ognized as safe for their intended use within the meaning of section 409 of the act are listed in this part. When the status of a substance has been re evaluated, it will be deleted from this part, and will be issued as a new regu lation under the appropriate part, e.g., ‘‘affirmed as GRAS’’ under part 184 or 186 of this chapter; ‘‘food additive regu lation’’ under parts 170 through 180 of this chapter; ‘‘interim food additive regulation’’ under part 180 of this chap ter; or ‘‘prohibited from use in food’’ under part 189 of this chapter. [42 FR 14640, Mar. 15, 1977, as amended at 53 FR 44875, Nov. 7, 1988] § 182.10 Spices and other natural seasonings and flavorings. Spices and other natural seasonings and flavorings that are generally rec ognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: 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 cassia Blume. Cassia, Padang or Batavia ..................................... Cinnamomum burmanni Blume. Cassia, Saigon ........................................................ Cinnamomum loureirii Nees. Cayenne pepper ...................................................... Capsicum frutescens L. or Capsicum annuum L. Celery seed ............................................................. Apium graveolens L. Chervil ..................................................................... Anthriscus cerefolium (L.) Hoffm. Chives ..................................................................... Allium schoenoprasum L. Cinnamon, Ceylon ................................................... Cinnamomum zeylanicum Nees. Cinnamon, Chinese ................................................. Cinnamomum cassia Blume. Cinnamon, Saigon ................................................... Cinnamomum loureirii Nees. Clary (clary sage) .................................................... Salvia sclarea L. Clover ...................................................................... Trifolium spp. Coriander ................................................................. Coriandrum sativum L. Cumin (cummin) ...................................................... Cuminum cyminum L. Cumin, black (black caraway) ................................. Nigella sativa L. Elder flowers ........................................................... Sambucus canadensis L. Fennel, common ..................................................... Foeniculum vulgare Mill. Fennel, sweet (finocchio, Florence fennel) ............. Foeniculum vulgare Mill. var. duice (DC.) Alex. Fenugreek ............................................................... Trigonella foenum-graecum L. Galanga (galangal) .................................................. Alpinia officinarum Hance. Geranium ................................................................. Pelargonium spp. Ginger ...................................................................... Zingiber officinale Rosc. Grains of paradise ................................................... Amomum melegueta Rosc. Horehound (hoarhound) .......................................... Marrubium vulgare L. Horseradish ............................................................. Armoracia lapathifolia Gilib. Hyssop .................................................................... Hyssopus officinalis L. Lavender ................................................................. Lavandula officinalis Chaix. Linden flowers ......................................................... Tilia spp. Mace ........................................................................ Myristica fragrans Houtt. VerDate Sep<11>2014 11:23 Apr 30, 2018 Jkt 244072 PO 00000 Frm 00487 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 478 21 CFR Ch. I (4–1–18 Edition) § 182.20 Common name Botanical name of plant source Marigold, pot ........................................................... Calendula officinalis L. Marjoram, pot .......................................................... Majorana onites (L.) Benth. Marjoram, sweet ...................................................... Majorana hortensis Moench. Mustard, black or brown ......................................... Brassica nigra (L.) Koch. Mustard, brown ....................................................... Brassica juncea (L.) Coss. Mustard, white or yellow ......................................... Brassica hirta Moench. Nutmeg .................................................................... Myristica fragrans Houtt. Oregano (oreganum, Mexican oregano, Mexican sage, origan). Lippia spp. Paprika .................................................................... Capsicum annuum L. Parsley .................................................................... 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. Peppermint .............................................................. Mentha piperita L. Poppy seed ............................................................. Papayer somniferum L. Pot marigold ............................................................ Calendula officinalis L. Pot marjoram ........................................................... Majorana onites (L.) Benth. Rosemary ................................................................ Rosmarinus officinalis L. Saffron ..................................................................... Crocus sativus L. Sage ........................................................................ Salvia officinalis L. Sage, Greek ............................................................ Salvia triloba L. Savory, summer ...................................................... Satureia hortensis L. (Satureja). Savory, winter ......................................................... Satureia montana L. (Satureja). Sesame ................................................................... Sesamum indicum L. Spearmint ................................................................ Mentha spicata L. Star anise ................................................................ Illicium verum Hook. f. Tarragon .................................................................. Artemisia dracunculus L. Thyme ..................................................................... Thymus vulgaris L. Thyme, wild or creeping .......................................... Thymus serpyllum L. Turmeric .................................................................. Curcuma longa L. Vanilla ...................................................................... Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore. Zedoary ................................................................... Curcuma zedoaria 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 vent-free), and natural extractives (including distillates). Essential oils, oleoresins (solvent free), and natural extractives (includ ing distillates) that are generally rec ognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: 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. VerDate Sep<11>2014 11:23 Apr 30, 2018 Jkt 244072 PO 00000 Frm 00488 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 479 Food and Drug Administration, HHS § 182.20 Common name Botanical name of plant source 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 ................................................................. Cymbopogon 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. 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. Maté ........................................................................ Ilex paraguariensis St. Hil. Melissa (see balm). Menthol .................................................................... Mentha spp. Menthyl acetate ....................................................... Do. VerDate Sep<11>2014 11:23 Apr 30, 2018 Jkt 244072 PO 00000 Frm 00489 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 480 21 CFR Ch. I (4–1–18 Edition) § 182.20 Common name Botanical name of plant source 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. Pomegranate ........................................................... 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 .......................................................... Schinus molle L. Sloe berries (blackthorn berries) ............................. Prunus spinosa L. Spearmint ................................................................ Mentha spicata L. Spike lavender ........................................................ Lavandula latifolia Vill. Tamarind ................................................................. 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, 21044, May 22, 1985] VerDate Sep<11>2014 11:23 Apr 30, 2018 Jkt 244072 PO 00000 Frm 00490 Fmt 8010 Sfmt 8016 Q:\21\21V3.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 481 Food and Drug Administration, HHS § 182.70 § 182.40 Natural extractives (solvent free) used in conjunction with spices, seasonings, and flavorings. Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: 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, seasonings, essential oils, oleoresins, and natural extracts. Certain other spices, seasonings, es sential oils, oleoresins, and natural ex tracts that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: 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 and adjuvants. Synthetic flavoring substances and adjuvants that are generally recog nized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: Acetaldehyde (ethanal). Acetoin (acetyl methylcarbinol). Anethole (parapropenyl anisole). Benzaldehyde (benzoic aldehyde). N-Butyric acid (butanoic acid). d- or l-Carvone (carvol). Cinnamaldehyde (cinnamic aldehyde). Citral (2,6-dimethyloctadien-2,6-al-8, gera nial, neral). Decanal (N-decylaldehyde, capraldehyde, capric aldehyde, caprinaldehyde, aldehyde C-10). Ethyl acetate. Ethyl butyrate. 3-Methyl-3-phenyl glycidic acid ethyl ester (ethyl-methyl-phenyl-glycidate, so-called strawberry aldehyde, C-16 aldehyde). Ethyl vanillin. Geraniol (3,7-dimethyl-2,6 and 3,6-octadien-1 ol). Geranyl acetate (geraniol acetate). Limonene (d-, l-, and dl-). Linalool (linalol, 3,7-dimethyl-1,6-octadien-3 ol). Linalyl acetate (bergamol). Methyl anthranilate (methyl-2 aminobenzoate). Piperonal (3,4-methylenedioxy-benzaldehyde, heliotropin). Vanillin. [42 FR 14640, Mar. 15, 1977, as amended at 43 FR 47724, Oct. 17, 1978; 44 FR 3963, Jan. 19, 1979; 44 FR 20656, Apr. 6, 1979; 48 FR 51907, Nov. 15, 1983; 54 FR 7402, Feb. 21, 1989] § 182.70 Substances migrating from cotton and cotton fabrics used in dry food packaging. Substances migrating to food from cotton and cotton fabrics used in dry food packaging that are generally rec ognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: Beef tallow. Carboxymethylcellulose. Coconut oil, refined. Cornstarch. Gelatin. Lard. Lard oil. Oleic acid. Peanut oil. Potato starch. Sodium acetate. Sodium chloride. VerDate Sep<11>2014 11:23 Apr 30, 2018 Jkt 244072 PO 00000 Frm 00491 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 482 21 CFR Ch. I (4–1–18 Edition) § 182.90 Sodium silicate. Sodium tripolyphosphate. Soybean oil (hydrogenated). Talc. Tallow (hydrogenated). Tallow flakes. Tapioca starch. Tetrasodium pyrophosphate. Wheat starch. Zinc chloride. [42 FR 14640, Mar. 15, 1977, as amended at 43 FR 11698, Mar. 21, 1978; 44 FR 28323, May 15, 1979; 45 FR 6085, Jan. 25, 1980; 47 FR 27807, 27814, June 25, 1982; 48 FR 51150, Nov. 7, 1983; 48 FR 51616, Nov. 10, 1983; 48 FR 51909, Nov. 15, 1983; 48 FR 52441, 52443, 52445, 52446, Nov. 18, 1983; 51 FR 16830, May 7, 1986; 51 FR 27171, July 30, 1986; 60 FR 62208, Dec. 5, 1995] § 182.90 Substances migrating to food from paper and paperboard prod ucts. Substances migrating to food from paper and paperboard products used in food packaging that are generally rec ognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: Alum (double sulfate of aluminum and am monium potassium, or sodium). Aluminum hydroxide. Aluminum oleate. Aluminum palmitate. Casein. Cellulose acetate. Cornstarch. Diatomaceous earth filler. Ethyl cellulose. Ethyl vanillin. Glycerin. Oleic acid. Potassium sorbate. Silicon dioxides. Sodium aluminate. Sodium chloride. Sodium hexametaphosphate. Sodium hydrosulfite. Sodium phosphoaluminate. Sodium silicate. Sodium sorbate. Sodium tripolyphosphate. Sorbitol. Soy protein, isolated. Starch, acid modified. Starch, pregelatinized. Starch, unmodified. Talc. Vanillin. Zinc hydrosulfite. Zinc sulfate. [42 FR 14640, Mar. 15, 1977] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 182.90, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 182.99 Adjuvants for pesticide chemi cals. Adjuvants, identified and used in ac cordance with 40 CFR 180.910 and 40 CFR 180.920, which are added to pes ticide use dilutions by a grower or ap plicator prior to application to the raw agricultural commodity, are exempt from the requirement of tolerances under section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348). [76 FR 59249, Sept. 26, 2011] Subpart B—Multiple Purpose GRAS Food Substances § 182.1045 Glutamic acid. (a) Product. Glutamic acid. (b) [Reserved] (c) Limitations, restrictions, or expla nation. This substance is generally rec ognized as safe when used as a salt sub stitute in accordance with good manu facturing practice. § 182.1047 Glutamic acid hydro chloride. (a) Product. Glutamic acid hydro chloride. (b) [Reserved] (c) Limitations, restrictions, or expla nation. This substance is generally rec ognized as safe when used as a salt sub stitute in accordance with good manu facturing practice. § 182.1057 Hydrochloric acid. (a) Product. Hydrochloric acid. (b) [Reserved] (c) Limitations, restrictions, or expla nation. This substance is generally rec ognized as safe when used as a buffer and neutralizing agent in accordance with good manufacturing practice. § 182.1073 Phosphoric acid. (a) Product. Phosphoric acid. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.1087 Sodium acid pyrophosphate. (a) Product. Sodium acid pyrophosphate. VerDate Sep<11>2014 11:23 Apr 30, 2018 Jkt 244072 PO 00000 Frm 00492 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 483 Food and Drug Administration, HHS § 182.1745 (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.1125 Aluminum sulfate. (a) Product. Aluminum sulfate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.1127 Aluminum ammonium sul fate. (a) Product. Aluminum ammonium sulfate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.1129 Aluminum potassium sul fate. (a) Product. Aluminum potassium sul fate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.1131 Aluminum sodium sulfate. (a) Product. Aluminum sodium sul fate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.1180 Caffeine. (a) Product. Caffeine. (b) Tolerance. 0.02 percent. (c) Limitations, restrictions, or expla nation. This substance is generally rec ognized as safe when used in cola-type beverages in accordance with good manufacturing practice. § 182.1217 Calcium phosphate. (a) Product. Calcium phosphate (mono-, di-, and tribasic). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.1235 Caramel. (a) Product. Caramel. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.1320 Glycerin. (a) Product. Glycerin. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.1480 Methylcellulose. (a) Product. U.S.P. methylcellulose, except that the methoxy content shall not be less than 27.5 percent and not more than 31.5 percent on a dry-weight basis. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.1500 Monoammonium glutamate. (a) Product. Monoammonium glu tamate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.1516 Monopotassium glutamate. (a) Product. Monopotassium glu tamate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.1711 Silica aerogel. (a) Product. Silica aerogel as a finely powdered microcellular silica foam having a minimum silica content of 89.5 percent. (b) [Reserved] (c) Limitations, restrictions, or expla nation. This substance is generally rec ognized as safe when used as a compo nent of an anti-foaming agent in ac cordance with good manufacturing practice. § 182.1745 Sodium carboxymethylcellu lose. (a) Product. Sodium carboxy methylcellulose is the sodium salt of carboxymethylcellulose not less than 99.5 percent on a dry-weight basis, with maximum substitution of 0.95 carboxymethyl groups per VerDate Sep<11>2014 11:23 Apr 30, 2018 Jkt 244072 PO 00000 Frm 00493 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 484 21 CFR Ch. I (4–1–18 Edition) § 182.1748 anhydroglucose unit, and with a min imum viscosity of 25 centipoises for 2 percent by weight aqueous solution at 25 °C. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.1748 Sodium caseinate. (a) Product. Sodium caseinate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.1778 Sodium phosphate. (a) Product. Sodium phosphate (mono-, di-, and tribasic). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.1781 Sodium aluminum phos phate. (a) Product. Sodium aluminum phos phate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.1810 Sodium tripolyphosphate. (a) Product. Sodium tripolyphosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. Subpart C—Anticaking Agents § 182.2122 Aluminum calcium silicate. (a) Product. Aluminum calcium sili cate. (b) Tolerance. 2 percent. (c) Limitations, restrictions, or expla nation. This substance is generally rec ognized as safe when used in table salt in accordance with good manufacturing practice. § 182.2227 Calcium silicate. (a) Product. Calcium silicate. (b) Tolerance. 2 percent and 5 percent. (c) Limitations, restrictions, or expla nation. This substance is generally rec ognized as safe when used at levels not exceeding 2 percent in table salt and 5 percent in baking powder in accordance with good manufacturing practice. § 182.2437 Magnesium silicate. (a) Product. Magnesium silicate. (b) Tolerance. 2 percent. (c) Limitations, restrictions, or expla nation. This substance is generally rec ognized as safe when used in table salt in accordance with good manufacturing practice. § 182.2727 Sodium aluminosilicate. (a) Product. Sodium aluminosilicate (sodium silicoaluminate). (b) Tolerance. This substance is gen erally recognized as safe for use at a level not exceeding 2 percent in accord ance with good manufacturing prac tice. § 182.2729 Sodium calcium aluminosilicate, hydrated. (a) Product. Hydrated sodium calcium aluminosilicate (sodium calcium silicoaluminate). (b) Tolerance. This substance is gen erally recognized as safe for use at a level not exceeding 2 percent in accord ance with good manufacturing prac tice. § 182.2906 Tricalcium silicate. (a) Product. Tricalcium silicate. (b) Tolerance. 2 percent. (c) Limitations, restrictions, or expla nation. This substance is generally rec ognized as safe when used in table salt in accordance with good manufacturing practice. Subpart D—Chemical Preservatives § 182.3013 Ascorbic acid. (a) Product. Ascorbic acid. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.3041 Erythorbic acid. (a) Product. Erythorbic acid. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. VerDate Sep<11>2014 11:23 Apr 30, 2018 Jkt 244072 PO 00000 Frm 00494 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 485 Food and Drug Administration, HHS § 182.3640 § 182.3089 Sorbic acid. (a) Product. Sorbic acid. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.3109 Thiodipropionic acid. (a) Product. Thiodipropionic acid. (b) Tolerance. This substance is gen erally recognized as safe for use in food when the total content of antioxidants is not over 0.02 percent of fat or oil content, including essential (volatile) oil content of the food, provided the substance is used in accordance with good manufacturing practice. § 182.3149 Ascorbyl palmitate. (a) Product. Ascorbyl palmitate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.3169 Butylated hydroxyanisole. (a) Product. Butylated hydroxy anisole. (b) Tolerance. This substance is gen erally recognized as safe for use in food when the total content of antioxidants is not over 0.02 percent of fat or oil content, including essential (volatile) oil content of food, provided the sub stance is used in accordance with good manufacturing practice. § 182.3173 Butylated hydroxytoluene. (a) Product. Butylated hydroxy toluene. (b) Tolerance. This substance is gen erally recognized as safe for use in food when the total content of antioxidants is not over 0.02 percent of fat or oil content, including essential (volatile) oil content of food, provided the sub stance is used in accordance with good manufacturing practice. § 182.3189 Calcium ascorbate. (a) Product. Calcium ascorbate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.3225 Calcium sorbate. (a) Product. Calcium sorbate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.3280 Dilauryl thiodipropionate. (a) Product. Dilauryl thiodipropionate. (b) Tolerance. This substance is gen erally recognized as safe for use in food when the total content of antioxidants is not over 0.02 percent of fat or oil content, including essential (volatile) oil content of the food, provided the substance is used in accordance with good manufacturing practice. § 182.3616 Potassium bisulfite. (a) Product. Potassium bisulfite. (b) [Reserved] (c) Limitations, restrictions, or expla nation. This substance is generally rec ognized as safe when used in accord ance with good manufacturing prac tice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits and vegetables in tended to be served raw to consumers or sold raw to consumers, or to be pre sented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994] § 182.3637 Potassium metabisulfite. (a) Product. Potassium metabisulfite. (b) [Reserved] (c) Limitations, restrictions, or expla nation. This substance is generally rec ognized as safe when used in accord ance with good manufacturing prac tice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits and vegetables in tended to be served raw to consumers or sold raw to consumers, or to be pre sented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994] § 182.3640 Potassium sorbate. (a) Product. Potassium sorbate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. VerDate Sep<11>2014 11:23 Apr 30, 2018 Jkt 244072 PO 00000 Frm 00495 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 486 21 CFR Ch. I (4–1–18 Edition) § 182.3731 1 For the purpose of this subpart, no at tempt has been made to designate those sequestrants that may also function as chemical preservatives. § 182.3731 Sodium ascorbate. (a) Product. Sodium ascorbate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.3739 Sodium bisulfite. (a) Product. Sodium bisulfite. (b) [Reserved] (c) Limitations, restrictions, or expla nation. This substance is generally rec ognized as safe when used in accord ance with good manufacturing prac tice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits or vegetables in tended to be served raw to consumers or sold raw to consumers, or to be pre sented to the consumer as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994] § 182.3766 Sodium metabisulfite. (a) Product. Sodium metabisulfite. (b) [Reserved] (c) Limitations, restrictions, or expla nation. This substance is generally rec ognized as safe when used in accord ance with good manufacturing prac tice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits or vegetables in tended to be served raw to consumers or sold raw to consumers, or to be pre sented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994] § 182.3795 Sodium sorbate. (a) Product. Sodium sorbate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.3798 Sodium sulfite. (a) Product. Sodium sulfite. (b) [Reserved] (c) Limitations, restrictions, or expla nation. This substance is generally rec ognized as safe when used in accord ance with good manufacturing prac tice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits or vegetables in tended to be served raw to consumers or sold raw to consumers, or to be pre sented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994] § 182.3862 Sulfur dioxide. (a) Product. Sulfur dioxide. (b) [Reserved] (c) Limitations, restrictions, or expla nation. This substance is generally rec ognized as safe when used in accord ance with good manufacturing prac tice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits or vegetables in tended to be served raw to consumers or sold raw to consumers, or to be pre sented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994] § 182.3890 Tocopherols. (a) Product. Tocopherols. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. Subpart E—Emulsifying Agents [Reserved] Subpart F—Dietary Supplements [Reserved] Subpart G—Sequestrants 1 § 182.6085 Sodium acid phosphate. (a) Product. Sodium acid phosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.6197 Calcium diacetate. (a) Product. Calcium diacetate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. VerDate Sep<11>2014 11:23 Apr 30, 2018 Jkt 244072 PO 00000 Frm 00496 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 487 Food and Drug Administration, HHS § 182.8159 § 182.6203 Calcium hexametaphosphate. (a) Product. Calcium hexametaphosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.6215 Monobasic calcium phos phate. (a) Product. Monobasic calcium phos phate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.6285 Dipotassium phosphate. (a) Product. Dipotassium phosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.6290 Disodium phosphate. (a) Product. Disodium phosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.6757 Sodium gluconate. (a) Product. Sodium gluconate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.6760 Sodium hexametaphosphate. (a) Product. Sodium hexametaphosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.6769 Sodium metaphosphate. (a) Product. Sodium metaphosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.6778 Sodium phosphate. (a) Product. Sodium phosphate (mono-, di-, and tribasic). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.6787 Sodium pyrophosphate. (a) Product. Sodium pyrophosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.6789 Tetra sodium pyrophosphate. (a) Product. Tetra sodium pyrophosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.6810 Sodium tripolyphosphate. (a) Product. Sodium tripolyphosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. Subpart H—Stabilizers § 182.7255 Chondrus extract. (a) Product. Chondrus extract (carrageenin). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. Subpart I—Nutrients SOURCE: 45 FR 58838, Sept. 5, 1980, unless otherwise noted. § 182.8013 Ascorbic acid. (a) Product. Ascorbic acid. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.8159 Biotin. (a) Product. Biotin. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. VerDate Sep<11>2014 11:23 Apr 30, 2018 Jkt 244072 PO 00000 Frm 00497 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 488 21 CFR Ch. I (4–1–18 Edition) § 182.8217 § 182.8217 Calcium phosphate. (a) Product. Calcium phosphate (mono-, di-, and tribasic). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.8223 Calcium pyrophosphate. (a) Product. Calcium pyrophosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.8250 Choline bitartrate. (a) Product. Choline bitartrate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.8252 Choline chloride. (a) Product. Choline chloride. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.8778 Sodium phosphate. (a) Product. Sodium phosphate (mono-, di-, and tribasic). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.8890 Tocopherols. (a) Product. Tocopherols. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.8892 α-Tocopherol acetate. (a) Product. a-Tocopherol acetate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.8985 Zinc chloride. (a) Product. Zinc chloride. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.8988 Zinc gluconate. (a) Product. Zinc gluconate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.8991 Zinc oxide. (a) Product. Zinc oxide. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.8994 Zinc stearate. (a) Product. Zinc stearate prepared from stearic acid free from chickedema factor. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. § 182.8997 Zinc sulfate. (a) Product. Zinc sulfate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing practice. PART 184—DIRECT FOOD SUB STANCES AFFIRMED AS GEN ERALLY RECOGNIZED AS SAFE Subpart A—General Provisions Sec. 184.1 Substances added directly to human food affirmed as generally recognized as safe (GRAS). Subpart B—Listing of Specific Substances Affirmed as GRAS 184.1005 Acetic acid. 184.1007 Aconitic acid. 184.1009 Adipic acid. 184.1011 Alginic acid. 184.1012 a-Amylase enzyme preparation from Bacillus stearothermophilus. 184.1021 Benzoic acid. 184.1024 Bromelain. 184.1025 Caprylic acid. 184.1027 Mixed carbohydrase and protease enzyme product. 184.1033 Citric acid. 184.1034 Catalase (bovine liver). 184.1061 Lactic acid. 184.1063 Enzyme-modified lecithin. 184.1065 Linoleic acid. 184.1069 Malic acid. VerDate Sep<11>2014 11:23 Apr 30, 2018 Jkt 244072 PO 00000 Frm 00498 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B