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CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2017]
[CITE: 21CFR182]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)
 
PART 182SUBSTANCES GENERALLY RECOGNIZED AS SAFE
 

Subpart A--General Provisions

Sec. 182.1 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, vinegar, baking powder, and monosodium glutamate as safe for their intended use. This part includes additional substances that, when used for the purposes indicated, in accordance with good manufacturing practice, are regarded by the Commissioner as generaly recognized as safe for such uses.

(b) For the purposes of this section, good manufacturing practice shall be defined to include the following restrictions:

(1) The quantity of a substance added to 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 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 food 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 humans.

(d) Substances that are generally recognized as safe for their intended use within the meaning of section 409 of the act are listed in this part. When the status of a substance has been reevaluated, it will be deleted from this part, and will be issued as a new regulation under the appropriate part, e.g., "affirmed as GRAS" under part 184 or 186 of this chapter; "food additive regulation" under parts 170 through 180 of this chapter; "interim food additive regulation" under part 180 of this chapter; or "prohibited from use in food" under part 189 of this chapter.

[42 FR 14640, Mar. 15, 1977, as amended at 53 FR 44875, Nov. 7, 1988]

Sec. 182.10 Spices and other natural seasonings and flavorings.

Spices and other natural seasonings and flavorings that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:

Common name Botanical name of plant source
Alfalfa herb and 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.
CorianderCoriandrum sativum L.
Cumin (cummin)Cuminum cyminum L.
Cumin, black (black caraway)Nigella sativa 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)Alpinia officinarum Hance.
GeraniumPelargonium spp.
GingerZingiber officinale Rosc.
Grains of paradiseAmomum melegueta Rosc.
Horehound (hoarhound)Marrubium vulgare L.
HorseradishArmoracia lapathifolia Gilib.
HyssopHyssopus officinalis L.
LavenderLavandula officinalis Chaix.
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 seedPapayer somniferum L.
Pot marigoldCalendula officinalis L.
Pot marjoramMajorana onites (L.) Benth.
RosemaryRosmarinus officinalis 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.

[42 FR 14640, Mar. 15, 1977, as amended at 43 FR 3705, Jan. 27, 1978; 44 FR 3963, Jan. 19, 1979; 50 FR 21044, May 22, 1985; 61 FR 14246, Apr. 1, 1996]

Sec. 182.20 Essential oils, oleoresins (solvent-free), and natural extractives (including distillates).

Essential oils, oleoresins (solvent-free), and natural extractives (including distillates) that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:

Common name Botanical name of plant source
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.
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.
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.
Dog grass (quackgrass, triticum)Agropyron repens (L.) Beauv.
Elder flowersSambucus canadensis L. and S. nigra I.
Estragole (esdragol, esdragon, tarragon)Artemisia dracunculus L.
Estragon (tarragon) Do.
Fennel, sweetFoeniculum vulgare Mill.
FenugreekTrigonella foenum-graecum L.
Galanga (galangal)Alpinia officinarum Hance.
GeraniumPelargonium spp.
Geranium, East IndianCymbopogon martini Stapf.
Geranium, rosePelargonium graveolens L'Her.
GingerZingiber officinale Rosc.
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.
JasmineJasminum 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 lexuosus Stapf.
Lemon peelCitrus limon (L.) Burm. f.
LimeCitrus aurantifolia Swingle.
Linden flowersTilia spp.
Locust beanCeratonia siliqua L,
LupulinHumulus lupulus L.
MaceMyristica fragrans Houtt.
MandarinCitrus reticulata Blanco.
Marjoram, sweetMajorana hortensis Moench.
MateIlex paraguariensis St. Hil.
Melissa (see balm)
MentholMentha spp.
Menthyl acetate Do.
Molasses (extract)Saccarum 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, white Do.
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 leafPimenta 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.
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.
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.

[42 FR 14640, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979; 47 FR 29953, July 9, 1982; 48 FR 51613, Nov. 10, 1983; 50 FR 21043, 21044, May 22, 1985]

Sec. 182.40 Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings.

Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:

Common name Botanical name of plant source
Apricot kernel (persic oil)Prunus armeniaca L.
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.

[42 FR 14640, Mar. 15, 1977, as amended at 47 FR 47375, Oct. 26, 1982]

Sec. 182.50 Certain other spices, seasonings, essential oils, oleoresins, and natural extracts.

Certain other spices, seasonings, essential oils, oleoresins, and natural extracts that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:

Common name Derivation
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.
Sec. 182.60 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).

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, gera-nial, neral).

Decanal (N -decylaldehyde, capraldehyde, capric aldehyde, caprinaldehyde, aldehyde C-10).

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.

Geraniol (3,7-dimethyl-2,6 and 3,6-octadien-1-ol ).

Geranyl acetate (geraniol acetate).

Limonene (d-, l-, and dl- ).

Linalool (linalol, 3,7-dimethyl-1,6-octadien-3-ol ).

Linalyl acetate (bergamol).

Methyl anthranilate (methyl-2-aminobenzoate).

Piperonal (3,4-methylenedioxy-benzaldehyde, heliotropin).

Vanillin.

[42 FR 14640, Mar. 15, 1977, as amended at 43 FR 47724, Oct. 17, 1978; 44 FR 3963, Jan. 19, 1979; 44 FR 20656, Apr. 6, 1979; 48 FR 51907, Nov. 15, 1983; 54 FR 7402, Feb. 21, 1989]

Sec. 182.70 Substances migrating from cotton and cotton fabrics used in dry food packaging.

Substances migrating to food from cotton and cotton fabrics used in dry food packaging that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:

Beef tallow.

Carboxymethylcellulose.

Coconut oil, refined.

Cornstarch.

Gelatin.

Lard.

Lard oil.

Oleic acid.

Peanut oil.

Potato starch.

Sodium acetate.

Sodium chloride.

Sodium silicate.

Sodium tripolyphosphate.

Soybean oil (hydrogenated).

Talc.

Tallow (hydrogenated).

Tallow flakes.

Tapioca starch.

Tetrasodium pyrophosphate.

Wheat starch.

Zinc chloride.

[42 FR 14640, Mar. 15, 1977, as amended at 43 FR 11698, Mar. 21, 1978; 44 FR 28323, May 15, 1979; 45 FR 6085, Jan. 25, 1980; 47 FR 27807, 27814, June 25, 1982; 48 FR 51150, Nov. 7, 1983; 48 FR 51616, Nov. 10, 1983; 48 FR 51909, Nov. 15, 1983; 48 FR 52441, 52443, 52445, 52446, Nov. 18, 1983; 51 FR 16830, May 7, 1986; 51 FR 27171, July 30, 1986; 60 FR 62208, Dec. 5, 1995]

Sec. 182.90 Substances migrating to food from paper and paperboard products.

Substances migrating to food from paper and paperboard products used in food packaging that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:

Alum (double sulfate of aluminum and ammonium potassium, or sodium).

Aluminum hydroxide.

Aluminum oleate.

Aluminum palmitate.

Casein.

Cellulose acetate.

Cornstarch.

Diatomaceous earth filler.

Ethyl cellulose.

Ethyl vanillin.

Glycerin.

Oleic acid.

Potassium sorbate.

Silicon dioxides.

Sodium aluminate.

Sodium chloride.

Sodium hexametaphosphate.

Sodium hydrosulfite.

Sodium phosphoaluminate.

Sodium silicate.

Sodium sorbate.

Sodium tripolyphosphate.

Sorbitol.

Soy protein, isolated.

Starch, acid modified.

Starch, pregelatinized.

Starch, unmodified.

Talc.

Vanillin.

Zinc hydrosulfite.

Zinc sulfate.

[42 FR 14640, Mar. 15, 1977]

Editorial Note:

For Federal Register citations affecting 182.90, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

Sec. 182.99 Adjuvants for pesticide chemicals.

Adjuvants, identified and used in accordance with 40 CFR 180.910 and 40 CFR 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 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348).

[76 FR 59249, Sept. 26, 2011]

Authority: 21 U.S.C. 321, 342, 348, 371.
Source: 42 FR 14640, Mar. 15, 1977, unless otherwise noted.

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