SUBSTANCES GENERALLY RECOGNIZED AS SAFE

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CFR Regulation

SUBSTANCES GENERALLY RECOGNIZED AS SAFE

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21 CFR Part 582

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§ 582.1Substances 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.

§ 582.10Spices 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.

§ 582.20Essential 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.

§ 582.30Natural 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.)

§ 582.40Natural 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.

§ 582.50Certain 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.

§ 582.60Synthetic 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.
Geraniol (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).
l -Malic acid.
Methyl anthranilate (methyl-2-aminobenzoate).
Piperonal (3,4-methylenedioxy-benzaldehyde, heliotropin).
Vanillin.

§ 582.80Trace 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.

§ 582.99Adjuvants for pesticide chemicals.

Adjuvants, identified and used in accordance with 40 CFR 180.910 and 180.920, 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.

§ 582.1005Acetic acid.

(a) Product. Acetic acid.