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Title 21: Food and Drugs

« Home / Title 21 - Food and Drugs--Volume 6 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS / PART 582 - SUBSTANCES GENERALLY RECOGNIZED AS SAFE / Subpart A - General Provisions

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 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.
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 fennel)	Foeniculum vulgare Mill. var. 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, 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	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:

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	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 peel)	Citrus aurantium L.
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, tarragon)	Artemisia dracunculus L.
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:

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:

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:

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.

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.