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[Code of Federal Regulations]

[Title 21, Volume 3]


[Revised as of April 1, 2018]
[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 182 SUBSTANCES 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 seed Medicago sativa L.
Allspice Pimenta officinalis Lindl.
Ambrette seed Hibiscus abelmoschus L.
Angelica archangelica L. or other spp. of
Angelica
Angelica.
Angelica root Do.
Angelica seed Do.
Angostura (cusparia bark) Galipea officinalis Hancock.
Anise Pimpinella anisum L.
Anise, star Illicium verum Hook. f.
Balm (lemon balm) Melissa officinalis L.
Basil, bush Ocimum minimum L.
Basil, sweet Ocimum basilicum L.
Bay Laurus nobilis L.
Calendula Calendula officinalis L.
Camomile (chamomile), English or Roman Anthemis nobilis L.
Camomile (chamomile), German or Hungarian Matricaria chamomilla L.
Capers Capparis spinosa L.
Capsicum frutescens L. or Capsicum
Capsicum
annuum L.
Caraway Carum carvi L.
Caraway, black (black cumin) Nigella sativa L.
Cardamom (cardamon) Elettaria cardamomum Maton.
Cassia, Chinese Cinnamomum cassia Blume.
Cassia, Padang or Batavia Cinnamomum burmanni Blume.
Cassia, Saigon Cinnamomum loureirii Nees.
Capsicum frutescens L. or Capsicum
Cayenne pepper
annuum L.
Celery seed Apium graveolens L.
Chervil Anthriscus cerefolium (L.) Hoffm.
Chives Allium schoenoprasum L.
Cinnamon, Ceylon Cinnamomum zeylanicum Nees.
Cinnamon, Chinese Cinnamomum cassia Blume.
Cinnamon, Saigon Cinnamomum loureirii Nees.
Clary (clary sage) Salvia sclarea L.
Clover Trifolium spp.
Coriander Coriandrum sativum L.
Cumin (cummin) Cuminum cyminum L.
Cumin, black (black caraway) Nigella sativa L.
Elder flowers Sambucus canadensis L.
Fennel, common Foeniculum vulgare Mill.
Foeniculum vulgare Mill. var. duice (DC.)
Fennel, sweet (finocchio, Florence fennel)
Alex.
Fenugreek Trigonella foenum-graecum L.
Galanga (galangal) Alpinia officinarum Hance.
Geranium Pelargonium spp.
Ginger Zingiber officinale Rosc.
Grains of paradise Amomum melegueta Rosc.
Horehound (hoarhound) Marrubium vulgare L.
Horseradish Armoracia lapathifolia Gilib.
Hyssop Hyssopus officinalis L.
Lavender Lavandula officinalis Chaix.
Linden flowers Tilia spp.
Mace Myristica fragrans Houtt.
Marigold, pot Calendula officinalis L.
Marjoram, pot Majorana onites (L.) Benth.
Marjoram, sweet Majorana hortensis Moench.
Mustard, black or brown Brassica nigra (L.) Koch.
Mustard, brown Brassica juncea (L.) Coss.
Mustard, white or yellow Brassica hirta Moench.
Nutmeg Myristica fragrans Houtt.
Oregano (oreganum, Mexican oregano,
Lippia spp.
Mexican sage, origan)
Paprika Capsicum annuum L.
Parsley Petroselinum crispum (Mill.) Mansf.
Pepper, black Piper nigrum L.
Capsicum frutescens L. or Capsicum
Pepper, cayenne
annuum L.
Pepper, red Do.
Pepper, white Piper nigrum L.
Peppermint Mentha piperita L.
Poppy seed Papayer somniferum L.
Pot marigold Calendula officinalis L.
Pot marjoram Majorana onites (L.) Benth.
Rosemary Rosmarinus officinalis L.
Saffron Crocus sativus L.
Sage Salvia officinalis L.
Sage, Greek Salvia triloba L.
Savory, summer Satureia hortensis L. (Satureja).
Savory, winter Satureia montana L. (Satureja).
Sesame Sesamum indicum L.
Spearmint Mentha spicata L.
Star anise Illicium verum Hook. f.
Tarragon Artemisia dracunculus L.
Thyme Thymus vulgaris L.
Thyme, wild or creeping Thymus serpyllum L.
Turmeric Curcuma longa L.
Vanilla planifolia Andr. or Vanilla tahitensis
Vanilla
J. W. Moore.
Zedoary Curcuma 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


Alfalfa Medicago sativa L.
Allspice Pimenta officinalis Lindl.
Almond, bitter (free from prussic Prunus amygdalus Batsch, Prunus armeniaca L., or
acid) Prunus persica (L.) Batsch.
Ambrette (seed) Hibiscus moschatus Moench.
Angelica root Angelica archangelica L.
Angelica seed Do.
Angelica stem Do.
Angostura (cusparia bark) Galipea officinalis Hancock.
Anise Pimpinella anisum L.
Asafetida Ferula assa-foetida L. and related spp. of Ferula.
Balm (lemon balm) Melissa officinalis L.
Balsam of Peru Myroxylon pereirae Klotzsch.
Basil Ocimum basilicum L.
Bay leaves Laurus nobilis L.
Bay (myrcia oil) Pimenta racemosa (Mill.) J. W. Moore.
Bergamot (bergamot orange) Citrus aurantium L. subsp. bergamia Wright et Arn.
Bitter almond (free from prussic Prunus amygdalus Batsch, Prunus armeniaca L., or
acid) Prunus persica (L.) Batsch.
Bois de rose Aniba rosaeodora Ducke.
Cacao Theobroma cacao L.
Camomile (chamomile) flowers,
Matricaria chamomilla L.
Hungarian
Camomile (chamomile) flowers,
Anthemis nobilis L.
Roman or English
Cananga Cananga odorata Hook. f. and Thoms.
Capsicum Capsicum frutescens L. and Capsicum annuum L.
Caraway Carum carvi L.
Cardamom seed (cardamon) Elettaria cardamomum Maton.
Carob bean Ceratonia siliqua L.
Carrot Daucus carota L.
Cascarilla bark Croton eluteria Benn.
Cassia bark, Chinese Cinnamomum cassia Blume.
Cassia bark, Padang or Batavia Cinnamomum burmanni Blume.
Cassia bark, Saigon Cinnamomum loureirii Nees.
Celery seed Apium graveolens L.
Cherry, wild, bark Prunus serotina Ehrh.
Chervil Anthriscus cerefolium (L.) Hoffm.
Chicory Cichorium intybus L.
Cinnamon bark, Ceylon Cinnamomum zeylanicum Nees.
Cinnamon bark, Chinese Cinnamomum cassia Blume.
Cinnamon bark, Saigon Cinnamomum loureirii Nees.
Cinnamon leaf, Ceylon Cinnamomum zeylanicum Nees.
Cinnamon leaf, Chinese Cinnamomum cassia Blume.
Cinnamon leaf, Saigon Cinnamomum loureirii Nees.
Citronella Cymbopogon nardus Rendle.
Citrus peels Citrus spp.
Clary (clary sage) Salvia sclarea L.
Clover Trifolium spp.
Coca (decocainized) Erythroxylum coca Lam. and other spp. of Erythroxylum.
Coffee Coffea spp.
Cola nut Cola acuminata Schott and Endl., and other spp. of Cola.
Coriander Coriandrum sativum L.
Cumin (cummin) Cuminum cyminum L.
Curacao orange peel (orange,
Citrus aurantium L.
bitter peel)
Cusparia bark Galipea officinalis Hancock.
Dandelion Taraxacum officinale Weber and T. laevigatum DC.
Dandelion root Do.
Dog grass (quackgrass, triticum) Agropyron repens (L.) Beauv.
Elder flowers Sambucus canadensis L. and S. nigra I.
Estragole (esdragol, esdragon,
Artemisia dracunculus L.
tarragon)
Estragon (tarragon) Do.
Fennel, sweet Foeniculum vulgare Mill.
Fenugreek Trigonella foenum-graecum L.
Galanga (galangal) Alpinia officinarum Hance.
Geranium Pelargonium spp.
Geranium, East Indian Cymbopogon martini Stapf.
Geranium, rose Pelargonium graveolens L'Her.
Ginger Zingiber officinale Rosc.
Grapefruit Citrus paradisi Macf.
Guava Psidium spp.
Hickory bark Carya spp.
Horehound (hoarhound) Marrubium vulgare L.
Hops Humulus lupulus L.
Horsemint Monarda punctata L.
Hyssop Hyssopus officinalis L.
Immortelle Helichrysum augustifolium DC.
Jasmine Jasminum officinale L. and other spp. of Jasminum.
Juniper (berries) Juniperus communis L.
Kola nut Cola acuminata Schott and Endl., and other spp. of Cola.
Laurel berries Laurus nobilis L.
Laurel leaves Laurus spp.
Lavender Lavandula officinalis Chaix.
Lavender, spike Lavandula latifolia Vill.
Hybrids between Lavandula officinalis Chaix and
Lavandin
Lavandula latifolin Vill.
Lemon Citrus limon (L.) Burm. f.
Lemon balm (see balm)
Cymbopogon citratus DC. and Cymbopogon lexuosus
Lemon grass
Stapf.
Lemon peel Citrus limon (L.) Burm. f.
Lime Citrus aurantifolia Swingle.
Linden flowers Tilia spp.
Locust bean Ceratonia siliqua L,
Lupulin Humulus lupulus L.
Mace Myristica fragrans Houtt.
Mandarin Citrus reticulata Blanco.
Marjoram, sweet Majorana hortensis Moench.
Mate Ilex paraguariensis St. Hil.
Melissa (see balm)
Menthol Mentha spp.
Menthyl acetate Do.
Molasses (extract) Saccarum officinarum L.
Mustard Brassica spp.
Naringin Citrus paradisi Macf.
Neroli, bigarade Citrus aurantium L.
Nutmeg Myristica fragrans Houtt.
Onion Allium cepa L.
Orange, bitter, flowers Citrus aurantium L.
Orange, bitter, peel Do.
Orange leaf Citrus sinensis (L.) Osbeck.
Orange, sweet Do.
Orange, sweet, flowers Do.
Orange, sweet, peel Do.
Origanum Origanum spp.
Palmarosa Cymbopogon martini Stapf.
Paprika Capsicum annuum L.
Parsley Petroselinum crispum (Mill.) Mansf.
Pepper, black Piper nigrum L.
Pepper, white Do.
Peppermint Mentha piperita L.
Peruvian balsam Myroxylon pereirae Klotzsch.
Petitgrain Citrus aurantium L.
Petitgrain lemon Citrus limon (L.) Burm. f.
Petitgrain mandarin or tangerine Citrus reticulata Blanco.
Pimenta Pimenta officinalis Lindl.
Pimenta leaf Pimenta officinalis Lindl.
Pipsissewa leaves Chimaphila umbellata Nutt.
Pomegranate Punica granatum L.
Xanthoxylum (or Zanthoxylum) Americanum Mill. or
Prickly ash bark
Xanthoxylum clava-herculis L.
Rosa alba L., Rosa centifolia L., Rosa damascena Mill.,
Rose absolute
Rosa gallica L., and vars. of these spp.
Rose (otto of roses, attar of roses) Do.
Rose buds Do.
Rose flowers Do.
Rose fruit (hips) Do.
Rose geranium Pelargonium graveolens L'Her.
Rose leaves Rosa spp.
Rosemary Rosmarinus officinalis L.
Saffron Crocus sativus L.
Sage Salvia officinalis L.
Sage, Greek Salvia triloba L.
Sage, Spanish Salvia lavandulaefolia Vahl.
St. John's bread Ceratonia siliqua L.
Savory, summer Satureia hortensis L.
Savory, winter Satureia montana L.
Schinus molle Schinus molle L.
Sloe berries (blackthorn berries) Prunus spinosa L.
Spearmint Mentha spicata L.
Spike lavender Lavandula latifolia Vill.
Tamarind Tamarindus indica L.
Tangerine Citrus reticulata Blanco.
Tarragon Artemisia dracunculus L.
Tea Thea sinensis L.
Thyme Thymus vulgaris L. and Thymus zygis var. gracilis Boiss.
Thyme, white Do.
Thyme, wild or creeping Thymus serpyllum L.
Triticum (see dog grass)
Tuberose Polianthes tuberosa L.
Turmeric Curcuma longa L.
Vanilla planifolia Andr. or Vanilla tahitensis J. W.
Vanilla
Moore.
Violet flowers Viola odorata L.
Violet leaves Do.
Violet leaves absolute Do.
Wild cherry bark Prunus serotina Ehrh.
Ylang-ylang Cananga odorata Hook. f. and Thoms.
Zedoary bark Curcuma zedoaria Rosc.
[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 stearine Arachis hypogaea L.
Persic oil (see apricot kernel and peach kernel)
Quince seed Cydonia 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


Ambergris Physeter macrocephalus L.
Castoreum Castor fiber L. and C. canadensis Kuhl.
Civet (zibeth, zibet, Civet cats, Viverra civetta Schreber and Viverra zibetha
zibetum) Schreber.
Cognac oil, white and green Ethyl 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]

Subpart B--Multiple Purpose GRAS Food Substances

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.
Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.
Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

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

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.
Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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]

Sec. 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]

Sec. 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.

Sec. 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.

Sec. 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]
Sec. 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]

Sec. 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.

Sec. 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]

Sec. 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]

Sec. 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--Sequestrants 1

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.
Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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

Sec. 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

Sec. 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.

Sec. 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.
Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.
Sec. 182.8892 [alpha]-Tocopherol acetate.

(a) Product. [alpha]-Tocopherol acetate.


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

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

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


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

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