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Electronic Code of Federal Regulations

e-CFR data is current as of December 11, 2019

Title 21Chapter ISubchapter EPart 582 → Subpart A


Title 21: Food and Drugs
PART 582—SUBSTANCES GENERALLY RECOGNIZED AS SAFE


Subpart A—General Provisions


Contents
§582.1   Substances that are generally recognized as safe.
§582.10   Spices and other natural seasonings and flavorings.
§582.20   Essential oils, oleoresins (solvent-free), and natural extractives (including distillates).
§582.30   Natural substances used in conjunction with spices and other natural seasonings and flavorings.
§582.40   Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings.
§582.50   Certain other spices, seasonings, essential oils, oleoresins, and natural extracts.
§582.60   Synthetic flavoring substances and adjuvants.
§582.80   Trace minerals added to animal feeds.
§582.99   Adjuvants for pesticide chemicals.

§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 nameBotanical name of plant source
Alfalfa herb and seedMedicago sativa L.
AllspicePimenta officinalis Lindl.
Ambrette seedHibiscus abelmoschus L.
AngelicaAngelica archangelica L. or other spp. of Angelica.
Angelica root      Do.
Angelica seed      Do.
Angostura (cusparia bark)Galipea officinalis Hancock.
AnisePimpinella anisum L.
Anise, starIllicium verum Hook. f.
Balm (lemon balm)Melissa officinalis L.
Basil, bushOcimum minimum L.
Basil, sweetOcimum basilicum L.
BayLaurus nobilis L.
CalendulaCalendula officinalis L.
Camomile (chamomile), English or RomanAnthemis nobilis L.
Camomile (chamomile), German or HungarianMatricaria chamomilla L.
CapersCapparis spinosa L.
CapsicumCapsicum frutescens L. or Capsicum annuum L.
CarawayCarum carvi L.
Caraway, black (black cumin)Nigella sativa L.
Cardamom (cardamon)Elettaria cardamomum Maton.
Cassia, ChineseCinnamomum cassia Blume.
Cassia, Padang or BataviaCinnamomum burmanni Blume.
Cassia, SaigonCinnamomum loureirii Nees.
Cayenne pepperCapsicum frutescens L. or Capsicum annuum L.
Celery seedApium graveolens L.
ChervilAnthriscus cerefolium (L.) Hoffm.
ChivesAllium schoenoprasum L.
Cinnamon, CeylonCinnamomum zeylanicum Nees.
Cinnamon, ChineseCinnamomum cassia Blume.
Cinnamon, SaigonCinnamomum loureirii Nees.
Clary (clary sage)Salvia sclarea L.
CloverTrifolium spp.
ClovesEugenia caryophyllata Thunb.
CorianderCoriandrum sativum L.
Cumin (cummin)Cuminum cyminum L.
Cumin, black (black caraway)Nigella sativa L.
DillAnethum graveolens L.
Elder flowersSambucus canadensis L.
Fennel, commonFoeniculum vulgare Mill.
Fennel, sweet (finocchio, Florence fennel)Foeniculum vulgare Mill. var. duice (DC.) Alex.
FenugreekTrigonella foenum-graecum L.
Galanga (galangal)Alpina officinarum Hance.
GarlicAllium sativum L.
GeraniumPelargonium spp.
GingerZingiber officinale Rosc.
GlycyrrhizaGlycyrrhiza glabra L. and other spp. of Glycyrrhiza.
Grains of paradiseAmomum melegueta Rosc.
Horehound (hoarhound)Marrubium vulgare L.
HorseradishArmoracia lapathifolia Gilib.
HyssopHyssopus officinalis L.
LavenderLavandula officinalis Chaix.
LicoriceGlycyrrhiza glabra L. and other spp. of Glycyrrhiza.
Linden flowersTilia spp.
MaceMyristica fragrans Houtt.
Marigold, potCalendula officinalis L.
Marjoram, potMajorana onites (L.) Benth.
Marjoram, sweetMajorana hortensis Moench.
Mustard, black or brownBrassica nigra (L.) Koch.
Mustard, brownBrassica juncea (L.) Coss.
Mustard, white or yellowBrassica hirta Moench.
NutmegMyristica fragrans Houtt.
Oregano (oreganum, Mexican oregano, Mexican sage, origan)Lippia spp.
PaprikaCapsicum annuum L.
ParsleyPetroselinum crispum (Mill.) Mansf.
Pepper, blackPiper nigrum L.
Pepper, cayenneCapsicum frutescens L. or Capsicum annuum L.
Pepper, red      Do.
Pepper, whitePiper nigrum L.
PeppermintMentha piperita L.
Poppy seedPapaver somniferum L.
Pot marigoldCalendula officinalis L.
Pot marjoramMajorana onites (L.) Benth.
RosemaryRosmarinus officinalis L.
RueRuta graveolens L.
SaffronCrocus sativus L.
SageSalvia officinalis L.
Sage, GreekSalvia triloba L.
Savory, summerSatureia hortensis L. (Satureja).
Savory, winterSatureia montana L. (Satureja).
SesameSesamum indicum L.
SpearmintMentha spicata L.
Star aniseIllicium verum Hook. f.
TarragonArtemisia dracunculus L.
ThymeThymus vulgaris L.
Thyme, wild or creepingThymus serpyllum L.
TurmericCurcuma longa L.
VanillaVanilla planifolia Andr. or Vanilla tahitensis J. W. Moore.
ZedoaryCurcuma 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 nameBotanical name of plant source
AlfalfaMedicago sativa L.
AllspicePimenta 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 rootAngelica archangelica L.
Angelica seed      Do.
Angelica stem      Do.
Angostura (cusparia bark)Galipea officinalis Hancock.
AnisePimpinella anisum L.
AsafetidaFerula assa-foetida L. and related spp. of Ferula.
Balm (lemon balm)Melissa officinalis L.
Balsam of PeruMyroxylon pereirae Klotzsch.
BasilOcimum basilicum L.
Bay leavesLaurus 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 roseAniba rosaeodora Ducke.
CacaoTheobroma cacao L.
Camomile (chamomile) flowers, HungarianMatricaria chamomilla L.
Camomile (chamomile) flowers, Roman or EnglishAnthemis nobilis L.
CanangaCananga odorata Hook. f. and Thoms.
CapsicumCapsicum frutescens L. and Capsicum annuum L.
CarawayCarum carvi L.
Cardamom seed (cardamon)Elettaria cardamomum Maton.
Carob beanCeratonia siliqua L.
CarrotDaucus carota L.
Cascarilla barkCroton eluteria Benn.
Cassia bark, ChineseCinnamomum cassia Blume.
Cassia bark, Padang or BataviaCinnamomum burmanni Blume.
Cassia bark, SaigonCinnamomum loureirii Nees.
Celery seedApium graveolens L.
Cherry, wild, barkPrunus serotina Ehrh.
ChervilAnthriscus cerefolium (L.) Hoffm.
ChicoryCichorium intybus L.
Cinnamon bark, CeylonCinnamomum zeylanicum Nees.
Cinnamon bark, ChineseCinnamomum cassia Blume.
Cinnamon bark, SaigonCinnamomum loureirii Nees.
Cinnamon leaf, CeylonCinnamomum zeylanicum Nees.
Cinnamon leaf, ChineseCinnamomum cassia Blume.
Cinnamon leaf, SaigonCinnamomum loureirii Nees.
CitronellaCymbopogon nardus Rendle.
Citrus peelsCitrus spp.
Clary (clary sage)Salvia sclarea L.
Clove budEugenia caryophyllata Thunb.
Clove leaf      Do.
Clove stem      Do.
CloverTrifolium spp.
Coca (decocainized)Erythroxylum coca Lam. and other spp. of Erythroxylum.
CoffeeCoffea spp.
Cola nutCola acuminata Schott and Endl., and other spp. of Cola.
CorianderCoriandrum sativum L.
Corn silkZea mays L.
Cumin (cummin)Cuminum cyminum L.
Curacao orange peel (orange, bitter peel)Citrus aurantium L.
Cusparia barkGalipea officinalis Hancock.
DandelionTaraxacum officinale Weber and T. laevigatum DC.
Dandelion root      Do.
DillAnethum graveolens L.
Dog grass (quackgrass, triticum)Agropyron repens (L.) Beauv.
Elder flowersSambucus canadensis L. and S. nigra L.
Estragole (esdragol, esdragon, tarragon)Artemisia dracunculus L.
Estragon (tarragon)      Do.
Fennel, sweetFoeniculum vulgare Mill.
FenugreekTrigonella foenum-graecum L.
Galanga (galangal)Alpinia officinarum Hance.
GarlicAllium sativum L.
GeraniumPelargonium spp.
Geranium, East IndianCymbopogon martini Stapf.
Geranium, rosePelargonium graveolens L'Her.
GingerZingiber officinale Rosc.
GlycyrrhizaGlycyrrhiza glabra L. and other spp. of Glycyrrhiza.
Glycyrrhizin, ammoniated      Do.
GrapefruitCitrus paradisi Macf.
GuavaPsidium spp.
Hickory barkCarya spp.
Horehound (hoarhound)Marrubium vulgare L.
HopsHumulus lupulus L.
HorsemintMonarda punctata L.
HyssopHyssopus officinalis L.
ImmortelleHelichrysum augustifolium DC.
JasmineJaminum officinale L. and other spp. of Jasminum.
Juniper (berries)Juniperus communis L.
Kola nutCola acuminata Schott and Endl., and other spp. of Cola.
Laurel berriesLaurus nobilis L.
Laurel leavesLaurus spp.
LavenderLavandula officinalis Chaix.
Lavender, spikeLavandula latifolia Vill.
LavandinHybrids between Lavandula officinalis Chaix and Lavandula latifolin Vill.
LemonCitrus limon (L.) Burm. f.
Lemon balm (see balm).
Lemon grassCymbopogon citratus DC. and Cymbopogon flexuosus Stapf.
Lemon peelCitrus limon (L.) Burm. f.
LicoriceGlycyrrhiza glabra L. and other spp. of Glycyrrhiza.
LimeCitrus aurantifolia Swingle.
Linden flowersTilia spp.
Locust beanCeratonia siliqua L.
LupulinHumulus lupulus L.
MaceMyristica fragrans Houtt.
Malt (extract)Hordeum vulgare L., or other grains.
MandarinCitrus reticulata Blanco.
Marjoram, sweetMajorana hortensis Moench.
Mate 1Ilex paraguariensis St. Hil.
Melissa (see balm).
MentholMentha spp.
Menthyl acetate      Do.
Molasses (extract)Saccharum officinarum L.
MustardBrassica spp.
NaringinCitrus paradisi Macf.
Neroli, bigaradeCitrus aurantium L.
NutmegMyristica fragrans Houtt.
OnionAllium cepa L.
Orange, bitter, flowersCitrus aurantium L.
Orange, bitter, peel      Do.
Orange leafCitrus sinensis (L.) Osbeck.
Orange, sweet      Do.
Orange, sweet, flowers      Do.
Orange, sweet, peel      Do.
OriganumOriganum spp.
PalmarosaCymbopogon martini Stapf.
PaprikaCapsicum annuum L.
ParsleyPetroselinum crispum (Mill.) Mansf.
Pepper, blackPiper nigrum L.
Pepper, whitePiper nigrum L.
PeppermintMentha piperita L.
Peruvian balsamMyroxylon pereirae Klotzsch.
PetitgrainCitrus aurantium L.
Petitgrain lemonCitrus limon (L.) Burm. f.
Petitgrain mandarin or tangerineCitrus reticulata Blanco.
PimentaPimenta officinalis Lindl.
Pimenta leafPrimenta officinalis Lindl.
Pipsissewa leavesChimaphila umbellata Nutt.
PomegranatePunica granatum L.
Prickly ash barkXanthoxylum (or Zanthoxylum) Americanum Mill. or Xanthoxylum clava-herculis L.
Rose absoluteRosa 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 geraniumPelargonium graveolens L'Her.
Rose leavesRosa spp.
RosemaryRosmarinus officinalis L.
RueRuta graveolens L.
SaffronCrocus sativus L.
SageSalvia officinalis L.
Sage, GreekSalvia triloba L.
Sage, SpanishSalvia lavandulaefolia Vahl.
St. John's breadCeratonia siliqua L.
Savory, summerSatureia hortensis L.
Savory, winterSatureia montana L.
Schinus molleSchinus molle L.
Sloe berries (blackthorn berries)Prunus spinosa L.
SpearmintMentha spicata L.
Spike lavenderLavandula latifolia Vill.
TamarindTamarindus indica L.
TangerineCitrus reticulata Blanco.
Tannic acidNutgalls of Quercus infectoria Oliver and related spp. of Quercus. Also in many other plants.
TarragonArtemisia dracunculus L.
TeaThea sinensis L.
ThymeThymus vulgaris L. and Thymus zygis var. gracilis Boiss.
Thyme, white      Do.
Thyme, wild or creepingThymus serpyllum L.
Triticum (see dog grass).
TuberosePolianthes tuberosa L.
TurmericCurcuma longa L.
VanillaVanilla planifolia Andr. or Vanilla tahitensis J. W. Moore.
Violet flowersViola odorata L.
Violet leaves      Do.
Violet leaves absolute      Do.
Wild cherry barkPrunus serotina Ehrh.
Ylang-ylangCananga odorata Hook. f. and Thoms.
Zedoary barkCurcuma 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 nameBotanical name of plant source
Algae, brown (kelp)Laminaria spp. and Nereocystis spp.
Algae, redPorphyra spp. and Rhodymenia palmata (L.) Grev.
DulseRhodymenia 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 nameBotanical name of plant source
Algae, brownLaminaria spp. and Nereocystis spp.
Algae, redPorphyra spp. and Rhodymenia palmata (L.) Grev.
Apricot kernel (persic oil)Prunus armeniaca L.
DulseRhodymenia palmata (L.) Grev.
Kelp (see algae, brown).
Peach kernel (persic oil)Prunus persica Sieb. et Zucc.
Peanut stearineArachis hypogaea L.
Persic oil (see apricot kernel and peach kernel).
Quince seedCydonia 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 nameDerivation
AmbergrisPhyseter macrocephalus L.
CastoreumCastor fiber L. and C. canadensis Kuhl.
Civet (zibeth, zibet, zibetum)Civet cats, Viverra civetta Schreber and Viverra zibetha Schreber.
Cognac oil, white and greenEthyl 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

1All substances listed may be in anhydrous or hydrated form.

ElementSource compounds
CobaltCobalt acetate.
   Cobalt carbonate.
   Cobalt chloride.
   Cobalt oxide.
   Cobalt sulfate.
CopperCopper carbonate.
   Copper chloride.
   Copper gluconate.
   Copper hydroxide.
   Copper orthophosphate.
   Copper oxide.
   Copper pyrophosphate.
   Copper sulfate.
IodineCalcium iodate.
   Calcium iodobehenate.
   Cuprous iodide.
   3,5-Diiodosalicylic acid.
   Ethylenediamine dihydroiodide.
   Potassium iodate.
   Potassium iodide.
   Sodium iodate.
   Sodium iodide.
   Thymol iodide.
IronIron ammonium citrate.
   Iron carbonate.
   Iron chloride.
   Iron gluconate.
   Iron oxide.
   Iron phosphate.
   Iron pyrophosphate.
   Iron sulfate.
   Reduced iron.
ManganeseManganese acetate.
   Manganese carbonate.
   Manganese citrate (soluble).
   Manganese chloride.
   Manganese gluconate.
   Manganese orthophosphate.
   Manganese phosphate (dibasic).
   Manganese sulfate.
   Manganous oxide.
ZincZinc 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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