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Electronic Code of Federal Regulations

e-CFR Data is current as of October 23, 2014

Title 21Chapter ISubchapter B → Part 182


Title 21: Food and Drugs


PART 182—SUBSTANCES GENERALLY RECOGNIZED AS SAFE


Contents

Subpart A—General Provisions

§182.1   Substances that are generally recognized as safe.
§182.10   Spices and other natural seasonings and flavorings.
§182.20   Essential oils, oleoresins (solvent-free), and natural extractives (including distillates).
§182.40   Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings.
§182.50   Certain other spices, seasonings, essential oils, oleoresins, and natural extracts.
§182.60   Synthetic flavoring substances and adjuvants.
§182.70   Substances migrating from cotton and cotton fabrics used in dry food packaging.
§182.90   Substances migrating to food from paper and paperboard products.
§182.99   Adjuvants for pesticide chemicals.

Subpart B—Multiple Purpose GRAS Food Substances

§182.1045   Glutamic acid.
§182.1047   Glutamic acid hydrochloride.
§182.1057   Hydrochloric acid.
§182.1073   Phosphoric acid.
§182.1087   Sodium acid pyrophosphate.
§182.1125   Aluminum sulfate.
§182.1127   Aluminum ammonium sulfate.
§182.1129   Aluminum potassium sulfate.
§182.1131   Aluminum sodium sulfate.
§182.1180   Caffeine.
§182.1217   Calcium phosphate.
§182.1235   Caramel.
§182.1320   Glycerin.
§182.1480   Methylcellulose.
§182.1500   Monoammonium glutamate.
§182.1516   Monopotassium glutamate.
§182.1711   Silica aerogel.
§182.1745   Sodium carboxymethylcellulose.
§182.1748   Sodium caseinate.
§182.1778   Sodium phosphate.
§182.1781   Sodium aluminum phosphate.
§182.1810   Sodium tripolyphosphate.

Subpart C—Anticaking Agents

§182.2122   Aluminum calcium silicate.
§182.2227   Calcium silicate.
§182.2437   Magnesium silicate.
§182.2727   Sodium aluminosilicate.
§182.2729   Sodium calcium aluminosilicate, hydrated.
§182.2906   Tricalcium silicate.

Subpart D—Chemical Preservatives

§182.3013   Ascorbic acid.
§182.3041   Erythorbic acid.
§182.3089   Sorbic acid.
§182.3109   Thiodipropionic acid.
§182.3149   Ascorbyl palmitate.
§182.3169   Butylated hydroxyanisole.
§182.3173   Butylated hydroxytoluene.
§182.3189   Calcium ascorbate.
§182.3225   Calcium sorbate.
§182.3280   Dilauryl thiodipropionate.
§182.3616   Potassium bisulfite.
§182.3637   Potassium metabisulfite.
§182.3640   Potassium sorbate.
§182.3731   Sodium ascorbate.
§182.3739   Sodium bisulfite.
§182.3766   Sodium metabisulfite.
§182.3795   Sodium sorbate.
§182.3798   Sodium sulfite.
§182.3862   Sulfur dioxide.
§182.3890   Tocopherols.

Subpart E—Emulsifying Agents [Reserved]

Subpart F—Dietary Supplements [Reserved]

Subpart G—Sequestrants

§182.6085   Sodium acid phosphate.
§182.6197   Calcium diacetate.
§182.6203   Calcium hexametaphosphate.
§182.6215   Monobasic calcium phosphate.
§182.6285   Dipotassium phosphate.
§182.6290   Disodium phosphate.
§182.6757   Sodium gluconate.
§182.6760   Sodium hexametaphosphate.
§182.6769   Sodium metaphosphate.
§182.6778   Sodium phosphate.
§182.6787   Sodium pyrophosphate.
§182.6789   Tetra sodium pyrophosphate.
§182.6810   Sodium tripolyphosphate.

Subpart H—Stabilizers

§182.7255   Chondrus extract.

Subpart I—Nutrients

§182.8013   Ascorbic acid.
§182.8159   Biotin.
§182.8217   Calcium phosphate.
§182.8223   Calcium pyrophosphate.
§182.8250   Choline bitartrate.
§182.8252   Choline chloride.
§182.8778   Sodium phosphate.
§182.8890   Tocopherols.
§182.8892   α-Tocopherol acetate.
§182.8985   Zinc chloride.
§182.8988   Zinc gluconate.
§182.8991   Zinc oxide.
§182.8994   Zinc stearate.
§182.8997   Zinc sulfate.

Authority: 21 U.S.C. 321, 342, 348, 371.

Source: 42 FR 14640, Mar. 15, 1977, unless otherwise noted.

Subpart A—General Provisions

§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]

§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 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.
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]

§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 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.
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.
MatéIlex 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 and 21044, May 22, 1985]

§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 nameBotanical 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]

§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 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.

§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]

§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]

§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 additional 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.

§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]

Subpart B—Multiple Purpose GRAS Food Substances

§182.1045   Glutamic acid.

(a) Product. Glutamic acid.

(b) [Reserved]

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

§182.1047   Glutamic acid hydrochloride.

(a) Product. Glutamic acid hydrochloride.

(b) [Reserved]

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

§182.1057   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 practice.

§182.1073   Phosphoric acid.

(a) Product. Phosphoric acid.

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

§182.1087   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 practice.

§182.1125   Aluminum sulfate.

(a) Product. Aluminum sulfate.

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

§182.1127   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 practice.

§182.1129   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 practice.

§182.1131   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 practice.

§182.1180   Caffeine.

(a) Product. Caffeine.

(b) Tolerance. 0.02 percent.

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

§182.1217   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 practice.

§182.1235   Caramel.

(a) Product. Caramel.

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

§182.1320   Glycerin.

(a) Product. Glycerin.

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

§182.1480   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 practice.

§182.1500   Monoammonium glutamate.

(a) Product. Monoammonium glutamate.

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

§182.1516   Monopotassium glutamate.

(a) Product. Monopotassium glutamate.

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

§182.1711   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 an anti-foaming agent in accordance with good manufacturing practice.

§182.1745   Sodium carboxymethylcellulose.

(a) Product. Sodium carboxymethylcellulose 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 °C.

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

§182.1748   Sodium caseinate.

(a) Product. Sodium caseinate.

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

§182.1778   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 practice.

§182.1781   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 practice.

§182.1810   Sodium tripolyphosphate.

(a) Product. Sodium tripolyphosphate.

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

Subpart C—Anticaking Agents

§182.2122   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 practice.

§182.2227   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 practice.

§182.2437   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 practice.

§182.2727   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 practice.

§182.2729   Sodium calcium aluminosilicate, hydrated.

(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 practice.

§182.2906   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 practice.

Subpart D—Chemical Preservatives

§182.3013   Ascorbic acid.

(a) Product. Ascorbic acid.

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

§182.3041   Erythorbic acid.

(a) Product. Erythorbic acid.

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

§182.3089   Sorbic acid.

(a) Product. Sorbic acid.

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

§182.3109   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 practice.

§182.3149   Ascorbyl palmitate.

(a) Product. Ascorbyl palmitate.

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

§182.3169   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 practice.

§182.3173   Butylated hydroxytoluene.

(a) Product. Butylated hydroxytoluene.

(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 practice.

§182.3189   Calcium ascorbate.

(a) Product. Calcium ascorbate.

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

§182.3225   Calcium sorbate.

(a) Product. Calcium sorbate.

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

§182.3280   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 practice.

§182.3616   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 practice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits and vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh.

[42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

§182.3637   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 practice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits and vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh.

[42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

§182.3640   Potassium sorbate.

(a) Product. Potassium sorbate.

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

§182.3731   Sodium ascorbate.

(a) Product. Sodium ascorbate.

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

§182.3739   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 practice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits or vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to the consumer as fresh.

[42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

§182.3766   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 practice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits or vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh.

[42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

§182.3795   Sodium sorbate.

(a) Product. Sodium sorbate.

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

§182.3798   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 practice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits or vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh.

[42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

§182.3862   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 practice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits or vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh.

[42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

§182.3890   Tocopherols.

(a) Product. Tocopherols.

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

Subpart E—Emulsifying Agents [Reserved]

Subpart F—Dietary Supplements [Reserved]

Subpart G—Sequestrants1

1For the purpose of this subpart, no attempt has been made to designate those sequestrants that may also function as chemical preservatives.

§182.6085   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 practice.

§182.6197   Calcium diacetate.

(a) Product. Calcium diacetate.

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

§182.6203   Calcium hexametaphosphate.

(a) Product. Calcium hexametaphosphate.

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

§182.6215   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 practice.

§182.6285   Dipotassium phosphate.

(a) Product. Dipotassium phosphate.

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

§182.6290   Disodium phosphate.

(a) Product. Disodium phosphate.

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

§182.6757   Sodium gluconate.

(a) Product. Sodium gluconate.

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

§182.6760   Sodium hexametaphosphate.

(a) Product. Sodium hexametaphosphate.

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

§182.6769   Sodium metaphosphate.

(a) Product. Sodium metaphosphate.

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

§182.6778   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 practice.

§182.6787   Sodium pyrophosphate.

(a) Product. Sodium pyrophosphate.

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

§182.6789   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 practice.

§182.6810   Sodium tripolyphosphate.

(a) Product. Sodium tripolyphosphate.

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

Subpart H—Stabilizers

§182.7255   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 practice.

Subpart I—Nutrients

Source: 45 FR 58838, Sept. 5, 1980, unless otherwise noted.

§182.8013   Ascorbic acid.

(a) Product. Ascorbic acid.

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

§182.8159   Biotin.

(a) Product. Biotin.

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

§182.8217   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 practice.

§182.8223   Calcium pyrophosphate.

(a) Product. Calcium pyrophosphate.

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

§182.8250   Choline bitartrate.

(a) Product. Choline bitartrate.

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

§182.8252   Choline chloride.

(a) Product. Choline chloride.

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

§182.8778   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 practice.

§182.8890   Tocopherols.

(a) Product. Tocopherols.

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

§182.8892   α-Tocopherol acetate.

(a) Product. α-Tocopherol acetate.

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

§182.8985   Zinc chloride.

(a) Product. Zinc chloride.

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

§182.8988   Zinc gluconate.

(a) Product. Zinc gluconate.

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

§182.8991   Zinc oxide.

(a) Product. Zinc oxide.

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

§182.8994   Zinc stearate.

(a) Product. Zinc stearate prepared from stearic acid free from chickedema factor.

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

§182.8997   Zinc sulfate.

(a) Product. Zinc sulfate.

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



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