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CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2013]
[CITE: 21CFR582]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
 
PART 582SUBSTANCES GENERALLY RECOGNIZED AS SAFE
 

Subpart A--General Provisions

Sec. 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.

Sec. 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 sativaL.
AllspicePimenta officinalisLindl.
Ambrette seedHibiscus abelmoschus L.
AngelicaAngelica archangelicaL. or other spp. of Angelica.
Angelica root Do.
Angelica seed Do.
Angostura (cusparia bark)Galipea officinalisHancock.
AnisePimpinella anisumL.
Anise, starIllicium verum Hook.f.
Balm (lemon balm)Melissa officinalisL.
Basil, bushOcimum minimumL.
Basil, sweetOcimum basilicum L.
BayLaurus nobilisL.
CalendulaCalendula officinalisL.
Camomile (chamomile), English or RomanAnthemis nobilisL.
Camomile (chamomile), German or HungarianMatricaria chamomillaL.
CapersCapparis spinosaL.
CapsicumCapsicum frutescensL. orCapsicum annuumL.
CarawayCarum carviL.
Caraway, black (black cumin)Nigella sativaL.
Cardamom (cardamon)Elettaria cardamomumMaton.
Cassia, ChineseCinnamomum cassiaBlume.
Cassia, Padang or BataviaCinnamomum burmanniBlume.
Cassia, SaigonCinnamomum loureiriiNees.
Cayenne pepperCapsicum frutescensL. orCapsicum annuumL.
Celery seedApium graveolensL.
ChervilAnthriscus cerefolium(L.) Hoffm.
ChivesAllium schoenoprasumL.
Cinnamon, CeylonCinnamomum zeylanicumNees.
Cinnamon, ChineseCinnamomum cassiaBlume.
Cinnamon, SaigonCinnamomum loureiriiNees.
Clary (clary sage)Salvia sclarea L.
CloverTrifoliumspp.
ClovesEugenia caryophyllataThunb.
CorianderCoriandrum sativumL.
Cumin (cummin)Cuminum cyminumL.
Cumin, black (black caraway)Nigella sativaL.
DillAnethum graveolensL.
Elder flowersSambucus canadensisL.
Fennel, commonFoeniculum vulgareMill.
Fennel, sweet (finocchio, Florence fennel)Foeniculum vulgareMill. var. duice (DC.) Alex.
FenugreekTrigonella foenum-graecumL.
Galanga (galangal)Alpina officinarumHance.
GarlicAllium sativumL.
GeraniumPelargoniumspp.
GingerZingiber officinaleRosc.
GlycyrrhizaGlycyrrhiza glabraL. and other spp. ofGlycyrrhiza.
Grains of paradiseAmomum meleguetaRosc.
Horehound (hoarhound)Marrubium vulgareL.
HorseradishArmoracia lapathifoliaGilib.
HyssopHyssopus officinalisL.
LavenderLavandula officinalisChaix.
LicoriceGlycyrrhiza glabraL. and other spp. ofGlycyrrhiza.
Linden flowersTiliaspp.
MaceMyristica fragransHoutt.
Marigold, potCalendula officinalisL.
Marjoram, potMajorana onites(L.) Benth.
Marjoram, sweetMajorana hortensisMoench.
Mustard, black or brownBrassica nigra(L.) Koch.
Mustard, brownBrassica juncea(L.) Coss.
Mustard, white or yellowBrassica hirtaMoench.
NutmegMyristica fragransHoutt.
Oregano (oreganum, Mexican oregano, Mexican sage, origan)Lippiaspp.
PaprikaCapsicum annuumL.
ParsleyPetroselinum crispum(Mill.) Mansf.
Pepper, blackPiper nigrumL.
Pepper, cayenneCapsicum frutescensL. orCapsicum annuumL.
Pepper, red Do.
Pepper, whitePiper nigrumL.
PeppermintMentha piperitaL.
Poppy seedPapaver somniferumL.
Pot marigoldCalendula officinalisL.
Pot marjoramMajorana onites(L.) Benth.
RosemaryRosmarinus officinalisL.
RueRuta graveolensL.
SaffronCrocus sativusL.
SageSalvia officinalisL.
Sage, GreekSalvia trilobaL.
Savory, summerSatureia hortensisL. (Satureja).
Savory, winterSatureia montanaL. (Satureja).
SesameSesamum indicumL.
SpearmintMentha spicataL.
Star aniseIllicium verumHook. f.
TarragonArtemisia dracunculusL.
ThymeThymus vulgarisL.
Thyme, wild or creepingThymus serpyllumL.
TurmericCurcuma longaL.
VanillaVanilla planifoliaAndr. orVanilla tahitensisJ. W. Moore.
ZedoaryCurcuma zedoariaRosc.
Sec. 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 sativaL.
AllspicePimenta officinalisLindl.
Almond, bitter (free from prussic acid)Prunus amygdalusBatsch,Prunus armeniacaL. orPrunus persica(L.) Batsch.
Ambrette (seed)Hibiscus moschatusMoench.
Angelica rootAngelica archangelicaL.
Angelica seed Do.
Angelica stem Do.
Angostura (cusparia bark)Galipea officinalisHancock.
AnisePimpinella anisumL.
AsafetidaFerula assa-foetidaL. and related spp. of Ferula.
Balm (lemon balm)Melissa officinalisL.
Balsam of PeruMyroxylon pereiraeKlotzsch.
BasilOcimum basilicumL.
Bay leavesLaurus nobilisL.
Bay (myrcia oil)Pimenta racemosa(Mill.) J. W. Moore.
Bergamot (bergamot orange)Citrus aurantiumL. subsp. bergamia Wright et Arn.
Bitter almond (free from prussic acid)Prunus amygdalusBatsch,Prunus armeniacaL., orPrunus persica(L.) Batsch.
Bois de roseAniba rosaeodoraDucke.
CacaoTheobroma cacaoL.
Camomile (chamomile) flowers, HungarianMatricaria chamomillaL.
Camomile (chamomile) flowers, Roman or EnglishAnthemis nobilisL.
CanangaCananga odorataHook. f. and Thoms.
CapsicumCapsicum frutescensL. andCapsicum annuumL.
CarawayCarum carviL.
Cardamom seed (cardamon)Elettaria cardamomumMaton.
Carob beanCeratonia siliquaL.
CarrotDaucus carotaL.
Cascarilla barkCroton eluteriaBenn.
Cassia bark, ChineseCinnamomum cassiaBlume.
Cassia bark, Padang or BataviaCinnamomum burmanniBlume.
Cassia bark, SaigonCinnamomum loureiriiNees.
Celery seedApium graveolensL.
Cherry, wild, barkPrunus serotinaEhrh.
ChervilAnthriscus cerefolium(L.) Hoffm.
ChicoryCichorium intybusL.
Cinnamon bark, CeylonCinnamomum zeylanicumNees.
Cinnamon bark, ChineseCinnamomum cassiaBlume.
Cinnamon bark, SaigonCinnamomum loureiriiNees.
Cinnamon leaf, CeylonCinnamomum zeylanicumNees.
Cinnamon leaf, ChineseCinnamomum cassiaBlume.
Cinnamon leaf, SaigonCinnamomum loureiriiNees.
CitronellaCymbopogon nardusRendle.
Citrus peelsCitrusspp.
Clary (clary sage)Salvia sclareaL.
Clove budEugenia caryophyllataThunb.
Clove leaf Do.
Clove stem Do.
CloverTrifoliumspp.
Coca (decocainized)Erythroxylum cocaLam. and other spp. of Erythroxylum.
CoffeeCoffeaspp.
Cola nutCola acuminataSchott and Endl., and other spp. of Cola.
CorianderCoriandrum sativumL.
Corn silkZea maysL.
Cumin (cummin)Cuminum cyminumL.
Curacao orange peel (orange, bitter peel)Citrus aurantiumL.
Cusparia barkGalipea officinalisHancock.
DandelionTaraxacum officinaleWeber andT. laevigatumDC.
Dandelion root Do.
DillAnethum graveolensL.
Dog grass (quackgrass, triticum)Agropyron repens(L.) Beauv.
Elder flowersSambucus canadensisL. and S. nigra L.
Estragole (esdragol, esdragon, tarragon)Artemisia dracunculusL.
Estragon (tarragon) Do.
Fennel, sweetFoeniculum vulgareMill.
FenugreekTrigonella foenum-graecumL.
Galanga (galangal)Alpinia officinarumHance.
GarlicAllium sativumL.
GeraniumPelargoniumspp.
Geranium, East IndianCymbopogon martiniStapf.
Geranium, rosePelargonium graveolensL'Her.
GingerZingiber officinaleRosc.
GlycyrrhizaGlycyrrhiza glabraL. and other spp. of Glycyrrhiza.
Glycyrrhizin, ammoniated Do.
GrapefruitCitrus paradisiMacf.
GuavaPsidiumspp.
Hickory barkCaryaspp.
Horehound (hoarhound)Marrubium vulgareL.
HopsHumulus lupulusL.
HorsemintMonarda punctataL.
HyssopHyssopus officinalisL.
ImmortelleHelichrysum augustifoliumDC.
JasmineJaminum officinaleL. and other spp. of Jasminum.
Juniper (berries)Juniperus communisL.
Kola nutCola acuminataSchott and Endl., and other spp. of Cola.
Laurel berriesLaurus nobilisL.
Laurel leavesLaurusspp.
LavenderLavandula officinalisChaix.
Lavender, spikeLavandula latifoliaVill.
LavandinHybrids betweenLavandula officinalisChaix andLavandula latifolinVill.
LemonCitrus limon(L.) Burm. f.
Lemon balm (see balm).
Lemon grassCymbopogon citratusDC. andCymbopogon flexuosusStapf.
Lemon peelCitrus limon(L.) Burm. f.
LicoriceGlycyrrhiza glabraL. and other spp. of Glycyrrhiza.
LimeCitrus aurantifoliaSwingle.
Linden flowersTiliaspp.
Locust beanCeratonia siliquaL.
LupulinHumulus lupulusL.
MaceMyristica fragransHoutt.
Malt (extract)Hordeum vulgareL., or other grains.
MandarinCitrus reticulataBlanco.
Marjoram, sweetMajorana hortensisMoench.
Mate 1Ilex paraguariensisSt. Hil.
Melissa (see balm).
MentholMenthaspp.
Menthyl acetate Do.
Molasses (extract)Saccharum officinarumL.
MustardBrassicaspp.
NaringinCitrus paradisiMacf.
Neroli, bigaradeCitrus aurantiumL.
NutmegMyristica fragransHoutt.
OnionAllium cepaL.
Orange, bitter, flowersCitrus aurantiumL.
Orange, bitter, peel Do.
Orange leafCitrus sinensis(L.) Osbeck.
Orange, sweet Do.
Orange, sweet, flowers Do.
Orange, sweet, peel Do.
OriganumOriganumspp.
PalmarosaCymbopogon martiniStapf.
PaprikaCapsicum annuumL.
ParsleyPetroselinum crispum(Mill.) Mansf.
Pepper, blackPiper nigrumL.
Pepper, whitePiper nigrumL.
PeppermintMentha piperitaL.
Peruvian balsamMyroxylon pereiraeKlotzsch.
PetitgrainCitrus aurantiumL.
Petitgrain lemonCitrus limon(L.) Burm. f.
Petitgrain mandarin or tangerineCitrus reticulataBlanco.
PimentaPimenta officinalisLindl.
Pimenta leafPrimenta officinalisLindl.
Pipsissewa leavesChimaphila umbellataNutt.
PomegranatePunica granatumL.
Prickly ash barkXanthoxylum(or Zanthoxylum)AmericanumMill. orXanthoxylum clava-herculisL.
Rose absoluteRosa albaL.,Rosa centifoliaL.,Rosa damascenaMill.,Rosa gallicaL., 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 graveolensL'Her.
Rose leavesRosaspp.
RosemaryRosmarinus officinalisL.
RueRuta graveolensL.
SaffronCrocus sativusL.
SageSalvia officinalisL.
Sage, GreekSalvia trilobaL.
Sage, SpanishSalvia lavandulaefoliaVahl.
St. John's breadCeratonia siliquaL.
Savory, summerSatureia hortensisL.
Savory, winterSatureia montanaL.
Schinus molleSchinus molleL.
Sloe berries (blackthorn berries)Prunus spinosaL.
SpearmintMentha spicataL.
Spike lavenderLavandula latifoliaVill.
TamarindTamarindus indicaL.
TangerineCitrus reticulataBlanco.
Tannic acidNutgalls ofQuercus infectoriaOliver and related spp. of Quercus. Also in many other plants.
TarragonArtemisia dracunculusL.
TeaThea sinensisL.
ThymeThymus vulgarisL. andThymus zygisvar. gracilis Boiss.
Thyme, white Do.
Thyme, wild or creepingThymus serpyllumL.
Triticum (see dog grass).
TuberosePolianthes tuberosaL.
TurmericCurcuma longaL.
VanillaVanilla planifoliaAndr. orVanilla tahitensisJ. W. Moore.
Violet flowersViola odorataL.
Violet leaves Do.
Violet leaves absolute Do.
Wild cherry barkPrunus serotinaEhrh.
Ylang-ylangCananga odorataHook. f. and Thoms.
Zedoary barkCurcuma zedoariaRosc.
Sec. 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)Laminariaspp. andNereocystisspp.
Algae, redPorphyraspp. andRhodymenia palmata(L.) Grev.
DulseRhodymenia palmata(L.)
Sec. 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, brownLaminariaspp. andNereocystisspp.
Algae, redPorphyraspp. andRhodymenia palmata(L.) Grev.
Apricot kernel (persic oil)Prunus armeniacaL.
DulseRhodymenia palmata(L.) Grev.
Kelp (see algae, brown).
Peach kernel (persic oil)Prunus persicaSieb. et Zucc.
Peanut stearineArachis hypogaeaL.
Persic oil (see apricot kernel and peach kernel).
Quince seedCydonia oblongaMiller.
Sec. 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 macrocephalusL.
CastoreumCastor fiber L. and C.canadensisKuhl.
Civet (zibeth, zibet, zibetum)Civet cats,Viverra civettaSchreber andViverra zibethaSchreber.
Cognac oil, white and greenEthyl oenanthate,so-called.
Musk (Tonquin musk)Musk deer,Moschus moschiferusL.
Sec. 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 - orl -Carvone (carvol).

Cinnamaldehyde (cinnamic aldehyde).

Citral (2,6-dimethyloctadien-2,6-al -8, geranial, neral).

Decanal (N -decylaldhehyde, capraldehyde, capric aldehyde, caprinaldehyde, aldehydeC -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.

Sec. 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

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.

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

Sec. 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.

Subpart B--General Purpose Food Additives

Sec. 582.1005 Acetic acid.

(a)Product. Acetic acid.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1009 Adipic acid.

(a)Product. Adipic acid.

(b) [Reserved]

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used as a buffer and neutralizing agent in accordance with good manufacturing or feeding practice.

Sec. 582.1033 Citric acid.

(a)Product. Citric acid.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1057 Hydrochloric acid.

(a)Product. Hydrochloric acid.

(b) [Reserved]

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used as a buffer and neutralizing agent in accordance with good manufacturing or feeding practice.

Sec. 582.1061 Lactic acid.

(a)Product. Lactic acid.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1069 Malic acid.

(a)Product. Malic acid.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1073 Phosphoric acid.

(a)Product. Phosphoric acid.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1077 Potassium acid tartrate.

(a)Product. Potassium acid tartrate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1087 Sodium acid pyrophosphate.

(a)Product. Sodium acid pyrophosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1091 Succinic acid.

(a)Product. Succinic acid.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1095 Sulfuric acid.

(a)Product. Sulfuric acid.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1099 Tartaric acid.

(a)Product. Tartaric acid.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1125 Aluminum sulfate.

(a)Product. Aluminum sulfate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1127 Aluminum ammonium sulfate.

(a)Product. Aluminum ammonium sulfate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1129 Aluminum potassium sulfate.

(a)Product. Aluminum potassium sulfate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1131 Aluminum sodium sulfate.

(a)Product. Aluminum sodium sulfate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1135 Ammonium bicarbonate.

(a)Product. Ammonium bicarbonate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1137 Ammonium carbonate.

(a)Product. Ammonium carbonate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1139 Ammonium hydroxide.

(a)Product. Ammonium hydroxide.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1141 Ammonium phosphate.

(a)Product. Ammonium phosphate (mono- and dibasic).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1143 Ammonium sulfate.

(a)Product. Ammonium sulfate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1155 Bentonite.

(a)Product. Bentonite.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1165 Butane.

(a)Product. Butane.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1191 Calcium carbonate.

(a)Product. Calcium carbonate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1193 Calcium chloride.

(a)Product. Calcium chloride.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1195 Calcium citrate.

(a)Product. Calcium citrate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1199 Calcium gluconate.

(a)Product. Calcium gluconate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1205 Calcium hydroxide.

(a)Product. Calcium hydroxide.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1207 Calcium lactate.

(a)Product. Calcium lactate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1210 Calcium oxide.

(a)Product. Calcium oxide.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1217 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 manufacturing or feeding practice.

Sec. 582.1235 Caramel.

(a)Product. Caramel.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1240 Carbon dioxide.

(a)Product. Carbon dioxide.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1275 Dextrans.

(a)Product. Dextrans of average molecular weight below 100,000.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1320 Glycerin.

(a)Product. Glycerin.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1324 Glyceryl monostearate.

(a)Product. Glyceryl monostearate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1355 Helium.

(a)Product. Helium.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1366 Hydrogen peroxide.

(a)Product. Hydrogen peroxide.

(b) [Reserved]

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used as a bleaching agent in accordance with good manufacturing or feeding practice.

Sec. 582.1400 Lecithin.

(a)Product. Lecithin.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1425 Magnesium carbonate.

(a)Product. Magnesium carbonate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1428 Magnesium hydroxide.

(a)Product. Magnesium hydroxide.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1431 Magnesium oxide.

(a)Product. Magnesium oxide.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1480 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 manufacturing or feeding practice.

Sec. 582.1500 Monoammonium glutamate.

(a)Product. Monoammonium glutamate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1516 Monopotassium glutamate.

(a)Product. Monopotassium glutamate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1540 Nitrogen.

(a)Product. Nitrogen.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1585 Papain.

(a)Product. Papain.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1613 Potassium bicarbonate.

(a)Product. Potassium bicarbonate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1619 Potassium carbonate.

(a)Product. Potassium carbonate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1625 Potassium citrate.

(a)Product. Potassium citrate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1631 Potassium hydroxide.

(a)Product. Potassium hydroxide.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1643 Potassium sulfate.

(a)Product. Potassium sulfate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1655 Propane.

(a)Product. Propane.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1666 Propylene glycol.

(a)Product. Propylene glycol.

(b)Conditions of use . This substance is generally recognized as safe (except in cat food) when used in accordance with good manufacturing or feeding practice.

[41 FR 38657, Sept. 10, 1976, as amended at 61 FR 19544, May 2, 1996]

Sec. 582.1685 Rennet.

(a)Product. Rennet (rennin).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1711 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 explanation. This substance is generally recognized as safe when used as a component of antifoaming agents in accordance with good manufacturing or feeding practice.

Sec. 582.1721 Sodium acetate.

(a)Product. Sodium acetate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1736 Sodium bicarbonate.

(a)Product. Sodium bicarbonate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1742 Sodium carbonate.

(a)Product. Sodium carbonate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1745 Sodium carboxymethylcellulose.

(a)Product. Sodium carboxymethyl- cellulose 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 anhydroglucose unit, and with a minimum viscosity of 25 centipoises for 2 percent by weight aqueous solution at 25 deg. C.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1748 Sodium caseinate.

(a)Product. Sodium caseinate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1751 Sodium citrate.

(a)Product. Sodium citrate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1763 Sodium hydroxide.

(a)Product. Sodium hydroxide.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1775 Sodium pectinate.

(a)Product. Sodium pectinate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1778 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 manufacturing or feeding practice.

Sec. 582.1781 Sodium aluminum phosphate.

(a)Product. Sodium aluminum phosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1792 Sodium sesquicarbonate.

(a)Product. Sodium sesquicarbonate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1804 Sodium potassium tartrate.

(a)Product. Sodium potassium tartrate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1810 Sodium tripolyphosphate.

(a)Product. Sodium tripolyphosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1901 Triacetin.

(a)Product. Triacetin (glyceryl triacetate).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1973 Beeswax.

(a)Product. Beeswax (yellow wax).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1975 Bleached beeswax.

(a)Product. Bleached beeswax (white wax).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.1978 Carnauba wax.

(a)Product. Carnauba wax.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Subpart C--Anticaking Agents

Sec. 582.2122 Aluminum calcium silicate.

(a)Product. Aluminum calcium silicate.

(b)Tolerance. 2 percent.

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in table salt in accordance with good manufacturing or feeding practice.

Sec. 582.2227 Calcium silicate.

(a)Product. Calcium silicate.

(b)Tolerance. 2 percent and 5 percent.

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used at levels not exceeding 2 percent in table salt and 5 percent in baking powder in accordance with good manufacturing or feeding practice.

Sec. 582.2437 Magnesium silicate.

(a)Product. Magnesium silicate.

(b)Tolerance. 2 percent.

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in table salt in accordance with good manufacturing or feeding practice.

Sec. 582.2727 Sodium aluminosilicate.

(a)Product. Sodium aluminosilicate (sodium silicoaluminate).

(b)Tolerance. This substance is generally recognized as safe for use at a level not exceeding 2 percent in accordance with good manufacturing or feeding practice.

Sec. 582.2729 Hydrated sodium calcium aluminosilicate.

(a)Product. Hydrated sodium calcium aluminosilicate (sodium calcium silicoaluminate).

(b)Tolerance. This substance is generally recognized as safe for use at a level not exceeding 2 percent in accordance with good manufacturing or feeding practice.

Sec. 582.2906 Tricalcium silicate.

(a)Product. Tricalcium silicate.

(b)Tolerance. 2 percent.

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in table salt in accordance with good manufacturing or feeding practice.

Subpart D--Chemical Preservatives

Sec. 582.3013 Ascorbic acid.

(a)Product. Ascorbic acid.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.3021 Benzoic acid.

(a)Product. Benzoic acid.

(b)Tolerance. This substance is generally recognized as safe for use at a level not exceeding 0.1 percent in accordance with good manufacturing or feeding practice.

Sec. 582.3041 Erythorbic acid.

(a)Product. Erythorbic acid.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.3081 Propionic acid.

(a)Product. Propionic acid.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.3089 Sorbic acid.

(a)Product. Sorbic acid.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.3109 Thiodipropionic acid.

(a)Product. Thiodipropionic acid.

(b)Tolerance. This substance is generally 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 or feeding practice.

Sec. 582.3149 Ascorbyl palmitate.

(a)Product. Ascorbyl palmitate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.3169 Butylated hydroxyanisole.

(a)Product. Butylated hydroxyanisole.

(b)Tolerance. This substance is generally 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 substance is used in accordance with good manufacturing or feeding practice.

Sec. 582.3173 Butylated hydroxytoluene.

(a)Product. Butylated hydroxytol- uene.

(b)Tolerance. This substance is generally 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 substance is used in accordance with good manufacturing or feeding practice.

Sec. 582.3189 Calcium ascorbate.

(a)Product. Calcium ascorbate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.3221 Calcium propionate.

(a)Product. Calcium propionate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.3225 Calcium sorbate.

(a)Product. Calcium sorbate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.3280 Dilauryl thiodipropionate.

(a)Product. Dilauryl thiodipropionate.

(b)Tolerance. This substance is generally 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 or feeding practice.

Sec. 582.3336 Gum guaiac.

(a)Product. Gum guaiac.

(b)Tolerance. 0.1 percent (equivalent antioxidant activity 0.01 percent).

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in edible fats or oils in accordance with good manufacturing or feeding practice.

Sec. 582.3490 Methylparaben.

(a)Product. Methylparaben (methylp -hydroxybenzoate).

(b)Tolerance. This substance is generally recognized as safe for use at a level not exceeding 0.1 percent in accordance with good manufacturing or feeding practice.

Sec. 582.3616 Potassium bisulfite.

(a)Product. Potassium bisulfite.

(b) [Reserved]

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice, except that it is not used in meats or in food recognized as source of vitamin B1.

Sec. 582.3637 Potassium metabisulfite.

(a)Product. Potassium metabisulfite.

(b) [Reserved]

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice, except that it is not used in meats or in food recognized as source of vitamin B1.

Sec. 582.3640 Potassium sorbate.

(a)Product. Potassium sorbate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.3660 Propyl gallate.

(a)Product. Propyl gallate.

(b)Tolerance. This substance is generally 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 or feeding practice.

Sec. 582.3670 Propylparaben.

(a)Product. Propylparaben (propylp -hydroxybenzoate).

(b)Tolerance. This substance is generally recognized as safe for use at a level not exceeding 0.1 percent in accordance with good manufacturing or feeding practice.

Sec. 582.3731 Sodium ascorbate.

(a)Product. Sodium ascorbate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.3733 Sodium benzoate.

(a)Product. Sodium benzoate.

(b)Tolerance. This substance is generally recognized as safe for use at a level not exceeding 0.1 percent in accordance with good manufacturing or feeding practice.

Sec. 582.3739 Sodium bisulfite.

(a)Product. Sodium bisulfite.

(b) [Reserved]

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice, except that it is not used in meats or in food recognized as source of vitamin B1.

Sec. 582.3766 Sodium metabisulfite.

(a)Product. Sodium metabisulfite.

(b) [Reserved]

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice, except that it is not used in meats or in food recognized as source of vitamin B1.

Sec. 582.3784 Sodium propionate.

(a)Product. Sodium propionate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.3795 Sodium sorbate.

(a)Product. Sodium sorbate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.3798 Sodium sulfite.

(a)Product. Sodium sulfite.

(b) [Reserved]

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice, except that it is not used in meats or in food recognized as source of vitamin B1.

Sec. 582.3845 Stannous chloride.

(a)Product. Stannous chloride.

(b)Tolerance. This substance is generally recognized as safe for use at a level not exceeding 0.0015 percent calculated as tin in accordance with good manufacturing or feeding practice.

Sec. 582.3862 Sulfur dioxide.

(a)Product. Sulfur dioxide.

(b) [Reserved]

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice, except that it is not used in meats or in food recognized as source of vitamin B1.

Sec. 582.3890 Tocopherols.

(a)Product. Tocopherols.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Subpart E--Emulsifying Agents

Sec. 582.4101 Diacetyl tartaric acid esters of mono- and diglycerides of edible fats or oils, or edible fat-forming fatty acids.

(a)Product. Diacetyl tartaric acid esters of mono- and diglycerides of edible fats or oils, or edible fat-forming fatty acids.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.4505 Mono- and diglycerides of edible fats or oils, or edible fat-forming acids.

(a)Product. Mono- and diglycerides of edible fats or oils, or edible fat-forming acids.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.4521 Monosodium phosphate derivatives of mono- and diglycerides of edible fats or oils, or edible fat-forming fatty acids.

(a)Product. Monosodium phosphate derivatives of mono- and diglycerides of edible fats or oils, or edible fat-forming fatty acids.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.4666 Propylene glycol.

(a)Product. Propylene glycol.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Subpart F--Nutrients and/or Dietary Supplements1

Sec. 582.5013 Ascorbic acid.

(a)Product. Ascorbic acid.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

1Amino acids listed in this subpart may be free hydrochloride salt, hydrated, or anhydrous form, where applicable.

Sec. 582.5017 Aspartic acid.

(a)Product. Aspartic acid (L- and DL-forms).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5049 Aminoacetic acid.

(a)Product. Glycine (aminoacetic acid).

(b) [Reserved]

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in animal feeds in accordance with good manufacturing or feeding practice.

Sec. 582.5065 Linoleic acid.

(a)Product. Linoleic acid prepared from edible fats and oils and free from chick-edema factor.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5118 Alanine.

(a)Product. Alanine (L- and DL-forms).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5145 Arginine.

(a)Product. Arginine (L- and DL-forms).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5159 Biotin.

(a)Product. Biotin.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5191 Calcium carbonate.

(a)Product. Calcium carbonate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5195 Calcium citrate.

(a)Product. Calcium citrate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5201 Calcium glycerophosphate.

(a)Product. Calcium glycerophosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5210 Calcium oxide.

(a)Product. Calcium oxide.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5212 Calcium pantothenate.

(a)Product. Calcium pantothenate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5217 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 manufacturing or feeding practice.

Sec. 582.5223 Calcium pyrophosphate.

(a)Product. Calcium pyrophosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5230 Calcium sulfate.

(a)Product. Calcium sulfate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5245 Carotene.

(a)Product. Carotene.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5250 Choline bitartrate.

(a)Product. Choline bitartrate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5252 Choline chloride.

(a)Product. Choline chloride.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5260 Copper gluconate.

(a)Product. Copper gluconate.

(b)Tolerance. This substance is generally recognized as safe for use at a level not exceeding 0.005 percent in accordance with good manufacturing or feeding practice.

Sec. 582.5271 Cysteine.

(a)Product. Cysteine (L-forms).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5273 Cystine.

(a)Product. Cystine (L- and DL-forms).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5301 Ferric phosphate.

(a)Product. Ferric phosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5304 Ferric pyrophosphate.

(a)Product. Ferric pyrophosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5306 Ferric sodium pyrophosphate.

(a)Product. Ferric sodium pyrophosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5308 Ferrous gluconate.

(a)Product. Ferrous gluconate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5311 Ferrous lactate.

(a)Product. Ferrous lactate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5315 Ferrous sulfate.

(a)Product. Ferrous sulfate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5361 Histidine.

(a)Product. Histidine (L- and DL-forms).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5370 Inositol.

(a)Product. Inositol.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5375 Iron reduced.

(a)Product. Iron reduced.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5381 Isoleucine.

(a)Product. Isoleucine (L- and DL-forms).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5406 Leucine.

(a)Product. Leucine (L- and DL-forms).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5411 Lysine.

(a)Product. Lysine (L- and DL-forms).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5431 Magnesium oxide.

(a)Product. Magnesium oxide.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5434 Magnesium phosphate.

(a)Product. Magnesium phosphate (di- and tribasic).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5443 Magnesium sulfate.

(a)Product. Magnesium sulfate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5446 Manganese chloride.

(a)Product. Manganese chloride.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5449 Manganese citrate.

(a)Product. Manganese citrate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5452 Manganese gluconate.

(a)Product. Manganese gluconate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5455 Manganese glycerophosphate.

(a)Product. Manganese glycerophosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5458 Manganese hypophosphite.

(a)Product. Manganese hypophosphite.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5461 Manganese sulfate.

(a)Product. Manganese sulfate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5464 Manganous oxide.

(a)Product. Manganous oxide.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5470 Mannitol.

(a)Product. Mannitol.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5475 Methionine.

(a)Product. Methionine.

(b) [Reserved]

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in animal feeds in accordance with good manufacturing or feeding practice.

Sec. 582.5477 Methionine hydroxy analog and its calcium salts.

(a)Product. Methionine hydroxy analog and its calcium salts.

(b) [Reserved]

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in animal feeds in accordance with good manufacturing or feeding practice.

Sec. 582.5530 Niacin.

(a)Product. Niacin.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5535 Niacinamide.

(a)Product. Niacinamide.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5580 D-Pantothenyl alcohol.

(a)Product. D-Pantothenyl alcohol.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5590 Phenylalanine.

(a)Product. Phenylalanine (L- and DL-forms).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5622 Potassium chloride.

(a)Product. Potassium chloride.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5628 Potassium glycerophosphate.

(a)Product. Potassium glycerophosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5634 Potassium iodide.

(a)Product. Potassium iodide.

(b)Tolerance. 0.01 percent.

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in table salt as a source of dietary iodine in accordance with good manufacturing or feeding practice.

Sec. 582.5650 Proline.

(a)Product. Proline (L- and DL-forms).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5676 Pyridoxine hydrochloride.

(a)Product. Pyridoxine hydrochloride.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5695 Riboflavin.

(a)Product. Riboflavin.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5697 Riboflavin-5-phosphate.

(a)Product. Riboflavin-5-phosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5701 Serine.

(a)Product. Serine (L- and DL-forms).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5772 Sodium pantothenate.

(a)Product. Sodium pantothenate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5778 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 manufacturing or feeding practice.

Sec. 582.5835 Sorbitol.

(a)Product. Sorbitol.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5875 Thiamine hydrochloride.

(a)Product. Thiamine hydrochloride.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5878 Thiamine mononitrate.

(a)Product. Thiamine mononitrate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5881 Threonine.

(a)Product. Threonine (L- and DL-forms).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5890 Tocopherols.

(a)Product. Tocopherols.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5892 a-Tocopherol acetate.

(a)Product. a -Tocopherol acetate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5915 Tryptophane.

(a)Product. Tryptophane (L- and DL-forms).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5920 Tyrosine.

(a)Product. Tyrosine (L- and DL-forms).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5925 Valine.

(a)Product. Valine (L- and DL-forms).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5930 Vitamin A.

(a)Product. Vitamin A.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5933 Vitamin A acetate.

(a)Product. Vitamin A acetate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5936 Vitamin A palmitate.

(a)Product. Vitamin A palmitate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5945 Vitamin B12.

(a)Product. Vitamin B12.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5950 Vitamin D2.

(a)Product. Vitamin D2.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5953 Vitamin D3.

(a)Product. Vitamin D3.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5985 Zinc chloride.

(a)Product. Zinc chloride.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5988 Zinc gluconate.

(a)Product. Zinc gluconate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5991 Zinc oxide.

(a)Product. Zinc oxide.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5994 Zinc stearate.

(a)Product. Zinc stearate prepared from stearic acid free from chick-edema factor.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.5997 Zinc sulfate.

(a)Product. Zinc sulfate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Subpart G--Sequestrants2

Sec. 582.6033 Citric acid.

(a)Product. Citric acid.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

2For the purpose of this subpart, no attempt has been made to designate those sequestrants that may also function as chemical preservatives.

Sec. 582.6085 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 manufacturing or feeding practice.

Sec. 582.6099 Tartaric acid.

(a)Product. Tartaric acid.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6185 Calcium acetate.

(a)Product. Calcium acetate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6193 Calcium chloride.

(a)Product. Calcium chloride.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6195 Calcium citrate.

(a)Product. Calcium citrate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6197 Calcium diacetate.

(a)Product. Calcium diacetate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6199 Calcium gluconate.

(a)Product. Calcium gluconate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6203 Calcium hexametaphosphate.

(a)Product. Calcium hexametaphosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6215 Monobasic calcium phosphate.

(a)Product. Monobasic calcium phosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6219 Calcium phytate.

(a)Product. Calcium phytate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6285 Dipotassium phosphate.

(a)Product. Dipotassium phosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6290 Disodium phosphate.

(a)Product. Disodium phosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6386 Isopropyl citrate.

(a)Product. Isopropyl citrate.

(b)Tolerance. This substance is generally recognized as safe for use at a level not exceeding 0.02 percent in accordance with good manufacturing or feeding practice.

Sec. 582.6511 Monoisopropyl citrate.

(a)Product. Monoisopropyl citrate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6625 Potassium citrate.

(a)Product. Potassium citrate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

[41 FR 38657, Sept. 10, 1976. Redesignated at 42 FR 14091, Mar. 15, 1977]

Sec. 582.6751 Sodium citrate.

(a)Product. Sodium citrate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

[41 FR 38657, Sept. 10, 1976. Redesignated at 42 FR 14091, Mar. 15, 1977]

Sec. 582.6754 Sodium diacetate.

(a)Product. Sodium diacetate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6757 Sodium gluconate.

(a)Product. Sodium gluconate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6760 Sodium hexametaphosphate.

(a)Product. Sodium hexametaphosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6769 Sodium metaphosphate.

(a)Product. Sodium metaphosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6778 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 manufacturing or feeding practice.

Sec. 582.6787 Sodium pyrophosphate.

(a)Product. Sodium pyrophosphate.

(b)Condition of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6789 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 manufacturing or feeding practice.

Sec. 582.6801 Sodium tartrate.

(a)Product. Sodium tartrate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6804 Sodium potassium tartrate.

(a)Product. Sodium potassium tartrate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6807 Sodium thiosulfate.

(a)Product. Sodium thiosulfate.

(b)Tolerance. 0.1 percent.

(c)Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in salt in accordance with good manufacturing or feeding practice.

Sec. 582.6810 Sodium tripolyphosphate.

(a)Product. Sodium tripolyphosphate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.6851 Stearyl citrate.

(a)Product. Stearyl citrate.

(b)Tolerance. This substance is generally recognized as safe for use at a level not exceeding 0.15 percent in accordance with good manufacturing or feeding practice.

Subpart H--Stabilizers

Sec. 582.7115 Agar-agar.

(a)Product. Agar-agar.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.7133 Ammonium alginate.

(a)Product. Ammonium alginate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.7187 Calcium alginate.

(a)Product. Calcium alginate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.7255 Chondrus extract.

(a)Product. Chondrus extract (carrageenin).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.7330 Gum arabic.

(a)Product. Acacia (gum arabic).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.7333 Gum ghatti.

(a)Product. Gum ghatti.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.7339 Guar gum.

(a)Product. Guar gum.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.7343 Locust bean gum.

(a)Product. Locust (carob) bean gum.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.7349 Sterculia gum.

(a)Product. Sterculia gum (karaya gum).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.7351 Gum tragacanth.

(a)Product. Tragacanth (gum tragacanth).

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.7610 Potassium alginate.

(a)Product. Potassium alginate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Sec. 582.7724 Sodium alginate.

(a)Product. Sodium alginate.

(b)Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Authority: 21 U.S.C. 321, 342, 348, 371.
Source: 41 FR 38657, Sept. 10, 1976, unless otherwise noted.

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