[Title 21 CFR 182]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 182 - SUBSTANCES GENERALLY RECOGNIZED AS SAFE]
[From the U.S. Government Publishing Office]
21
FOOD AND DRUGS
3
1996-04-01
1996-04-01
false
SUBSTANCES GENERALLY RECOGNIZED AS SAFE
182
PART 182
FOOD AND DRUGS
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
FOOD FOR HUMAN CONSUMPTION
PART 182--SUBSTANCES GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart A--General Provisions
Sec.
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.
182.1866 High fructose corn syrup.
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.
[[Page 418]]
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
182.5013 Ascorbic acid.
182.5065 Linoleic acid.
182.5159 Biotin.
182.5191 Calcium carbonate.
182.5195 Calcium citrate.
182.5201 Calcium glycerophosphate.
182.5210 Calcium oxide.
182.5212 Calcium pantothenate.
182.5217 Calcium phosphate.
182.5223 Calcium pyrophosphate.
182.5245 Carotene.
182.5250 Choline bitartrate.
182.5252 Choline chloride.
182.5260 Copper gluconate.
182.5301 Ferric phosphate.
182.5304 Ferric pyrophosphate.
182.5306 Ferric sodium pyrophosphate.
182.5308 Ferrous gluconate.
182.5311 Ferrous lactate.
182.5315 Ferrous sulfate.
182.5370 Inositol.
182.5375 Iron reduced.
182.5431 Magnesium oxide.
182.5434 Magnesium phosphate.
182.5443 Magnesium sulfate.
182.5446 Manganese chloride.
182.5449 Manganese citrate.
182.5452 Manganese gluconate.
182.5455 Manganese glycerophosphate.
182.5461 Manganese sulfate.
182.5464 Manganous oxide.
182.5484 Manganese hypophosphite.
182.5530 Niacin.
182.5535 Niacinamide.
182.5580 D-Pantothenyl alcohol.
182.5622 Potassium chloride.
182.5628 Potassium glycerophosphate.
182.5676 Pyridoxine hydrochloride.
182.5695 Riboflavin.
182.5697 Riboflavin-5'-phosphate.
182.5772 Sodium pantothenate.
182.5778 Sodium phosphate.
182.5875 Thiamine hydrochloride.
182.5878 Thiamine mononitrate.
182.5890 Tocopherols.
182.5892 a-Tocopherol acetate.
182.5930 Vitamin A.
182.5933 Vitamin A acetate.
182.5936 Vitamin A palmitate.
182.5945 Vitamin B12.
182.5950 Vitamin D2.
182.5953 Vitamin D3.
182.5985 Zinc chloride.
182.5988 Zinc gluconate.
182.5991 Zinc oxide.
182.5994 Zinc stearate.
182.5997 Zinc sulfate.
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 a-Tocopherol acetate.
182.8985 Zinc chloride.
182.8988 Zinc gluconate.
182.8991 Zinc oxide.
182.8994 Zinc stearate.
182.8997 Zinc sulfate.
Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 342, 348, 371).
Source: 42 FR 14640, Mar. 15, 1977, unless otherwise noted.
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.
[[Page 419]]
(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........................ Angelica archangelica L. or other spp.
of 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 Anthemis nobilis L.
Roman.
Camomile (chamomile), German or Matricaria chamomilla L.
Hungarian.
Capers.......................... Capparis spinosa L.
Capsicum........................ Capsicum frutescens L. or 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.
Cayenne pepper.................. Capsicum frutescens L. or Capsicum
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.
[[Page 420]]
Cumin, black (black caraway).... Nigella sativa L.
Elder flowers................... Sambucus canadensis L.
Fennel, common.................. Foeniculum vulgare Mill.
Fennel, sweet (finocchio, Foeniculum vulgare Mill. var. duice
Florence fennel). (DC.) 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 Lippia spp.
oregano, Mexican sage, origan).
Paprika......................... Capsicum annuum L.
Parsley......................... Petroselinum crispum (Mill.) Mansf.
Pepper, black................... Piper nigrum L.
Pepper, cayenne................. Capsicum frutescens L. or Capsicum
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......................... Vanilla planifolia Andr. or Vanilla
tahitensis 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).
------------------------------------------------------------------------
Common name Botanical name of plant source
------------------------------------------------------------------------
Alfalfa......................... Medicago sativa L.
Allspice........................ Pimenta officinalis Lindl.
Almond, bitter (free from Prunus amygdalus Batsch, Prunus
prussic acid). armeniaca L., or 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.
[[Page 421]]
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
acid). armeniaca L., or 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.
Lavandin........................ Hybrids between Lavandula officinalis
Chaix and Lavandula latifolin Vill.
[[Page 422]]
Lemon........................... Citrus limon (L.) Burm. f.
Lemon balm (see balm)...........
Lemon grass..................... Cymbopogon citratus DC. and Cymbopogon
lexuosus 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.
Prickly ash bark................ Xanthoxylum (or Zanthoxylum)
Americanum Mill. or Xanthoxylum clava-
herculis L.
Rose absolute................... Rosa alba L., Rosa centifolia L., Rosa
damascena Mill., Rosa gallica L., and
vars. of these spp.
Rose (otto of roses, attar of Do.
roses).
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 Prunus spinosa L.
berries).
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.
[[Page 423]]
Vanilla......................... Vanilla planifolia Andr. or Vanilla
tahitensis J. W. 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 and
21044, May 22, 1985]
Sec. 182.40 Natural extractives (solvent-free) used in conjunction
with spices, seasonings, and flavorings.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
Common name Derivation
------------------------------------------------------------------------
Ambergris....................... Physeter macrocephalus L.
Castoreum....................... Castor fiber L. and C. canadensis
Kuhl.
Civet (zibeth, zibet, zibetum).. Civet cats, Viverra civetta Schreber
and Viverra zibetha 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).
[[Page 424]]
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 additional Federal Register citations affecting
Sec. 182.90, see the List of CFR Sections Affected in the Finding Aids
section of this volume.
Sec. 182.99 Adjuvants for pesticide chemicals.
Adjuvants, identified and used in accordance with 40 CFR 180.1001
(c) and (d), which are added to pesticide use dilutions by a grower or
applicator prior to application to the raw agricultural commodity, are
exempt from the requirement of tolerances under section 409 of the Act.
Subpart B--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]
[[Page 425]]
(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.
[[Page 426]]
(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.
Sec. 182.1866 High fructose corn syrup.
(a) Product. High fructose corn syrup is a sweet, nutritive
saccharide mixture containing approximately 52 percent (dry weight)
glucose, 43 percent (dry weight) fructose, and 5 percent (dry weight)
other saccharides. It is prepared as a clear aqueous solution from high
dextrose equivalent corn starch hydrolysate by partial enzymatic
conversion of glucose (dextrose) to fructose utilizing an insoluble
glucose isomerase enzyme preparation described in Sec. 184.1372 of this
chapter.
(b) Limitations, restrictions, or explanations. This substance is
generally recognized as safe when used in food as a nutritive
carbohydrate sweetener at levels not to exceed current good
manufacturing practice.
[48 FR 5719, Feb. 8, 1983]
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
[[Page 427]]
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
[[Page 428]]
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]
[[Page 429]]
(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\1\
Sec. 182.5013 Ascorbic acid.
(a) Product. Ascorbic acid.
---------------------------------------------------------------------------
\1\ Amino acids listed in this subpart may be free hydrochloride
salt, hydrated, or anhydrous form, where applicable.
---------------------------------------------------------------------------
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5065 Linoleic acid.
(a) Product. Linoleic acid prepared from edible fats and oils and
free from chickedema factor.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5159 Biotin.
(a) Product. Biotin.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5191 Calcium carbonate.
(a) Product. Calcium carbonate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5195 Calcium citrate.
(a) Product. Calcium citrate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5201 Calcium glycerophosphate.
(a) Product. Calcium glycerophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5210 Calcium oxide.
(a) Product. Calcium oxide.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5212 Calcium pantothenate.
(a) Product. Calcium pantothenate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5217 Calcium phosphate.
(a) Product. Calcium phosphate (mono-, di-, and tribasic).
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5223 Calcium pyrophosphate.
(a) Product. Calcium pyrophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5245 Carotene.
(a) Product. Carotene.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5250 Choline bitartrate.
(a) Product. Choline bitartrate.
(b) Conditions of use. This substance is generally recognized as
safe when
[[Page 430]]
used in accordance with good manufacturing practice.
Sec. 182.5252 Choline chloride.
(a) Product. Choline chloride.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5260 Copper gluconate.
(a) Product. Copper gluconate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with current good manufacturing practice.
[49 FR 24119, June 12, 1984]
Sec. 182.5301 Ferric phosphate.
(a) Product. Ferric phosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5304 Ferric pyrophosphate.
(a) Product. Ferric pyrophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5306 Ferric sodium pyrophosphate.
(a) Product. Ferric sodium pyrophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5308 Ferrous gluconate.
(a) Product. Ferrous gluconate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5311 Ferrous lactate.
(a) Product. Ferrous lactate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5315 Ferrous sulfate.
(a) Product. Ferrous sulfate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5370 Inositol.
(a) Product. Inositol.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5375 Iron reduced.
(a) Product. Iron reduced.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5431 Magnesium oxide.
(a) Product. Magnesium oxide.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5434 Magnesium phosphate.
(a) Product. Magnesium phosphate (di- and tribasic).
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5443 Magnesium sulfate.
(a) Product. Magnesium sulfate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5446 Manganese chloride.
(a) Product. Manganese chloride.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5449 Manganese citrate.
(a) Product. Manganese citrate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5452 Manganese gluconate.
(a) Product. Manganese gluconate.
[[Page 431]]
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5455 Manganese glycerophosphate.
(a) Product. Manganese glycerophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5461 Manganese sulfate.
(a) Product. Manganese sulfate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5464 Manganous oxide.
(a) Product. Manganous oxide.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5484 Manganese hypophosphite.
(a) Product. Manganese hypophosphite.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
[45 FR 58838, Sept. 5, 1980. Redesignated at 61 FR 14246, Apr. 1, 1996]
Sec. 182.5530 Niacin.
(a) Product. Niacin.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5535 Niacinamide.
(a) Product. Niacinamide.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5580 D-Pantothenyl alcohol.
(a) Product. D-Pantothenyl alcohol.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5622 Potassium chloride.
(a) Product. Potassium chloride.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with current good manufacturing practice.
Preparations containing amounts equal to or greater than 100 milligrams
of potassium per tablet or capsule, or 20 milligrams of potassium per
milliliter, are drugs subject to the provisions of Sec. 201.306 of this
chapter.
[42 FR 14640, Mar. 15, 1977, as amended at 48 FR 51614, Nov. 10, 1983]
Sec. 182.5628 Potassium glycerophosphate.
(a) Product. Potassium glycerophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5676 Pyridoxine hydrochloride.
(a) Product. Pyridoxine hydrochloride.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5695 Riboflavin.
(a) Product. Riboflavin.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5697 Riboflavin-5' phosphate.
(a) Product. Riboflavin-5' phosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice. [42 FR
14640, Mar. 15, 1977, as amended at 61 FR 14246, Apr. 1, 1996]
Sec. 182.5772 Sodium pantothenate.
(a) Product. Sodium pantothenate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5778 Sodium phosphate.
(a) Product. Sodium phosphate (mono-, di-, and tribasic).
(b) Conditions of use. This substance is generally recognized as
safe when
[[Page 432]]
used in accordance with good manufacturing practice.
Sec. 182.5875 Thiamine hydrochloride.
(a) Product. Thiamine hydrochloride.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5878 Thiamine mononitrate.
(a) Product. Thiamine mononitrate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5890 Tocopherols.
(a) Product. Tocopherols.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5892 a-Tocopherol acetate.
(a) Product. a-Tocopherol acetate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5930 Vitamin A.
(a) Product. Vitamin A.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5933 Vitamin A acetate.
(a) Product. Vitamin A acetate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5936 Vitamin A palmitate.
(a) Product. Vitamin A palmitate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5945 Vitamin B12.
(a) Product. Vitamin B12.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5950 Vitamin D2.
(a) Product. Vitamin D2.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5953 Vitamin D3.
(a) Product. Vitamin D3.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5985 Zinc chloride.
(a) Product. Zinc chloride.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5988 Zinc gluconate.
(a) Product. Zinc gluconate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5991 Zinc oxide.
(a) Product. Zinc oxide.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Sec. 182.5994 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. 182.5997 Zinc sulfate.
(a) Product. Zinc sulfate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
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
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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
Source: 45 FR 58838, Sept. 5, 1980, unless otherwise noted.
Sec. 182.8013 Ascorbic acid.
(a) Product. Ascorbic acid.
(b) Conditions of use. This substance is generally recognized as
safe when
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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 -Tocopherol acetate.
(a) Product. -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.