21 C.F.R. Subpart A—General Provisions
Title 21 - Food and Drugs
Title 21: Food and Drugs
PART 582—SUBSTANCES GENERALLY RECOGNIZED AS SAFE
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Subpart A—General Provisions
§ 582.1 Substances that are generally recognized as safe.
(a) It is impracticable to list all substances that are generally recognized as safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, sugar, vinegar, baking powder, and monosodium glutamate as safe for their intended use. The lists in subparts B through H of this part include additional substances that, when used for the purposes indicated, in accordance with good manufacturing or feeding practice, are regarded by the Commissioner as generally recognized as safe for such uses.
(b) For the purposes of this section, good manufacturing or feeding practice shall be defined to include the following restrictions:
(1) The quantity of a substance added to animal 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 animal food as a result 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 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 grade or lot of the substance is of suitable 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 supplement to the diet for animals.
(d) Substances that are generally recognized as safe for their intended use within the meaning of section 409 of the Act are listed in subparts B through H of this part. When the status of a substance has been reevaluated and affirmed as GRAS or deleted from subparts B through H of this part, an appropriate explanation will be noted, e.g., “affirmed as GRAS,” “food additive regulation,” “interim food additive regulation,” or “prohibited from use in food,” with a reference to the appropriate new regulation. Such notation will apply only to the specific use covered by the review, e.g., direct animal food use and/or indirect animal food use and/or animal feed use and will not affect its status for other uses not specified in the referenced regulation, pending a specific review of such other uses.
§ 582.10 Spices and other natural seasonings and flavorings.
Spices and other natural 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------------------------------------------------------------------------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 Matricaria chamomilla L. Hungarian.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.Cloves................................. Eugenia caryophyllata Thunb.Coriander.............................. Coriandrum sativum L.Cumin (cummin)......................... Cuminum cyminum L.Cumin, black (black caraway)........... Nigella sativa L.Dill................................... Anethum graveolens L.Elder flowers.......................... Sambucus canadensis L.Fennel, common......................... Foeniculum vulgare Mill.Fennel, sweet (finocchio, Florence Foeniculum vulgare Mill. var. fennel). duice (DC.) Alex.Fenugreek.............................. Trigonella foenum-graecum L.Galanga (galangal)..................... Alpina officinarum Hance.Garlic................................. Allium sativum L.Geranium............................... Pelargonium spp.Ginger................................. Zingiber officinale Rosc.Glycyrrhiza............................ Glycyrrhiza glabra L. and other spp. of Glycyrrhiza.Grains of paradise..................... Amomum melegueta Rosc.Horehound (hoarhound).................. Marrubium vulgare L.Horseradish............................ Armoracia lapathifolia Gilib.Hyssop................................. Hyssopus officinalis L.Lavender............................... Lavandula officinalis Chaix.Licorice............................... Glycyrrhiza glabra L. and other spp. of Glycyrrhiza.Linden flowers......................... Tilia spp.Mace................................... Myristica fragrans Houtt.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, Lippia spp. Mexican sage, origan).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............................. Papaver somniferum L.Pot marigold........................... Calendula officinalis L.Pot marjoram........................... Majorana onites (L.) Benth.Rosemary............................... Rosmarinus officinalis L.Rue.................................... Ruta graveolens 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.------------------------------------------------------------------------
§ 582.20 Essential oils, oleoresins (solvent-free), and natural extractives (including distillates).
Essential oils, oleoresins (solvent-free), and natural extractives (including distillates) that are generally recognized as safe for their intended use, within the meaning of section 409 of the act, are as follows:
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------------------------------------------------------------------------ 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 Anthemis nobilis L. English.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............................. Cymbopogon nardus Rendle.Citrus peels........................... Citrus spp.Clary (clary sage)..................... Salvia sclarea L.Clove bud.............................. Eugenia caryophyllata Thunb.Clove leaf............................. Do.Clove stem............................. Do.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.Corn silk.............................. Zea mays L.Cumin (cummin)......................... Cuminum cyminum L.Curacao orange peel (orange, bitter Citrus aurantium L. peel).Cusparia bark.......................... Galipea officinalis Hancock.Dandelion.............................. Taraxacum officinale Weber and T. laevigatum DC.Dandelion root......................... Do.Dill................................... Anethum graveolens L.Dog grass (quackgrass, triticum)....... Agropyron repens (L.) Beauv.Elder flowers.......................... Sambucus canadensis L. and S. nigra L.Estragole (esdragol, esdragon, Artemisia dracunculus L. tarragon).Estragon (tarragon).................... Do.Fennel, sweet.......................... Foeniculum vulgare Mill.Fenugreek.............................. Trigonella foenum-graecum L.Galanga (galangal)..................... Alpinia officinarum Hance.Garlic................................. Allium sativum L.Geranium............................... Pelargonium spp.Geranium, East Indian.................. Cymbopogon martini Stapf.Geranium, rose......................... Pelargonium graveolens L'Her.Ginger................................. Zingiber officinale Rosc.Glycyrrhiza............................ Glycyrrhiza glabra L. and other spp. of Glycyrrhiza.Glycyrrhizin, ammoniated............... Do.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................................ Jaminum 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 flexuosus Stapf.Lemon peel............................. Citrus limon (L.) Burm. f.Licorice............................... Glycyrrhiza glabra L. and other spp. of Glycyrrhiza.Lime................................... Citrus aurantifolia Swingle.Linden flowers......................... Tilia spp.Locust bean............................ Ceratonia siliqua L.Lupulin................................ Humulus lupulus L.Mace................................... Myristica fragrans Houtt.Malt (extract)......................... Hordeum vulgare L., or other grains.Mandarin............................... Citrus reticulata Blanco.Marjoram, sweet........................ Majorana hortensis Moench.Mate 1................................. Ilex paraguariensis St. Hil.Melissa (see balm).Menthol................................ Mentha spp.Menthyl acetate........................ Do.Molasses (extract)..................... Saccharum 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.......................... Piper nigrum L.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........................... Primenta 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.Rue.................................... Ruta graveolens 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.Tannic acid............................ Nutgalls of Quercus infectoria Oliver and related spp. of Quercus. Also in many other plants.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.------------------------------------------------------------------------
§ 582.30 Natural substances used in conjunction with spices and other natural seasonings and flavorings.
Natural substances used in conjunction with spices and other natural 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:
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------------------------------------------------------------------------ Common name Botanical name of plant source------------------------------------------------------------------------Algae, brown (kelp).................... Laminaria spp. and Nereocystis spp.Algae, red............................. Porphyra spp. and Rhodymenia palmata (L.) Grev.Dulse.................................. Rhodymenia palmata (L.)------------------------------------------------------------------------
§ 582.40 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:
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------------------------------------------------------------------------ Common name Botanical name of plant source------------------------------------------------------------------------Algae, brown........................... Laminaria spp. and Nereocystis spp.Algae, red............................. Porphyra spp. and Rhodymenia palmata (L.) Grev.Apricot kernel (persic oil)............ Prunus armeniaca L.Dulse.................................. Rhodymenia palmata (L.) Grev.Kelp (see algae, brown).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.------------------------------------------------------------------------
§ 582.50 Certain other spices, seasonings, essential oils, oleoresins, and natural extracts.
Certain other spices, seasonings, essential oils, oleoresins, and natural extracts that are generally recognized as safe for their intended use, within the meaning of section 409 of the act, are as follows:
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------------------------------------------------------------------------ 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.------------------------------------------------------------------------
§ 582.60 Synthetic flavoring substances and adjuvants.
Synthetic flavoring substances and adjuvants that are generally recognized as safe for their intended use, within the meaning of section 409 of the act, are as follows:
Acetaldehyde (ethanal).
Acetoin (acetyl methylcarbinol).
Aconitic acid (equisetic acid, citridic acid, achilleic acid).
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, geranial, neral).
Decanal (N-decylaldhehyde, capraldehyde, capric aldehyde, caprinaldehyde, aldehyde C-10).
Diacetyl (2,3-butandeione). 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.
Eugenol.
Geranoil (3,7-dimethyl-2,6 and 3,6-octadien-1-ol).
Geranyl acetate (geraniol acetate).
Glycerol (glyceryl) tributyrate (tributyrin, butyrin).
Limonene (d-, l-, and dl-).
Linalool (linalol, 3,7-dimethyl-1,6-octadien-3-ol).
Linalyl acetate (bergamol).
1-Malic acid.
Methyl anthranilate (methyl-2-aminobenzoate).
Piperonal (3,4-methylenedioxy-benzaldehyde, heliotropin).
Vanillin. § 582.80 Trace minerals added to animal feeds.
These substances added to animal feeds as nutritional dietary supplements are generally recognized as safe when added at levels consistent with good feeding practice.1
1 All substances listed may be in anhydrous or hydrated form.
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------------------------------------------------------------------------ Element Source compounds------------------------------------------------------------------------Cobalt................................ Cobalt acetate. Cobalt carbonate. Cobalt chloride. Cobalt oxide. Cobalt sulfate.Copper................................ Copper carbonate. Copper chloride. Copper gluconate. Copper hydroxide. Copper orthophosphate. Copper oxide. Copper pyrophosphate. Copper sulfate.Iodine................................ Calcium iodate. Calcium iodobehenate. Cuprous iodide. 3,5-Diiodosalicylic acid. Ethylenediamine dihydroiodide. Potassium iodate. Potassium iodide. Sodium iodate. Sodium iodide. Thymol iodide.Iron.................................. Iron ammonium citrate. Iron carbonate. Iron chloride. Iron gluconate. Iron oxide. Iron phosphate. Iron pyrophosphate. Iron sulfate. Reduced iron.Manganese............................. Manganese acetate. Manganese carbonate. Manganese citrate (soluble). Manganese chloride. Manganese gluconate. Manganese orthophosphate. Manganese phosphate (dibasic). Manganese sulfate. Manganous oxide.Zinc.................................. Zinc acetate. Zinc carbonate. Zinc chloride. Zinc oxide. Zinc sulfate.------------------------------------------------------------------------
§ 582.99 Adjuvants for pesticide chemicals.
Adjuvants, identified and used in accordance with 40 CFR 180.1001(c) and (d), which are added to pesticide use dilutions by a grower or applicator prior to application to the raw agricultural commodity, are exempt from the requirement of tolerances under section 409 of the act.
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