529 Food and Drug Administration, HHS Pt. 582 (a) Energy sources. Ionizing radiation is limited to gamma rays from sealed units of cobalt-60. (b) Limitation. The ionizing radiation is used for feed or feed ingredients that do not contain drugs. (c) Use. Ionizing radiation is used as a single treatment for rendering com- plete poultry diets or poultry feed in- gredients salmonella negative as fol- lows: (1) Minimum dose 2.0 kiloGrays (kGy) (0.2 megarad (Mrad)); maximum dose 25 kGy (2.5 megarads Mrad). The absorbed dose of irradiation is to be based on ini- tial concentration of salmonella using the relationship that 1.0 kGy (0.1 Mrad) reduces salmonella concentration by one log cycle (one decimal reduction). (2) Feeds treated by irradiation should be formulated to account for nutritional loss. (3) If an irradiated feed ingredient is less than 5 percent of the final product, the final product can be irradiated without being considered to be re- irradiated. [60 FR 50099, Sept. 28, 1995] PART 582—SUBSTANCES GENERALLY RECOGNIZED AS SAFE Subpart A—General Provisions Sec. 582.1 Substances that are generally recog- nized as safe. 582.10 Spices and other natural seasonings and flavorings. 582.20 Essential oils, oleoresins (solvent- free), and natural extractives (including distillates). 582.30 Natural substances used in conjunc- tion with spices and other natural seasonings and flavorings. 582.40 Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings. 582.50 Certain other spices, seasonings, es- sential oils, oleoresins, and natural ex- tracts. 582.60 Synthetic flavoring substances and adjuvants. 582.80 Trace minerals added to animal feeds. 582.99 Adjuvants for pesticide chemicals. Subpart B—General Purpose Food Additives 582.1005 Acetic acid. 582.1009 Adipic acid. 582.1033 Citric acid. 582.1057 Hydrochloric acid. 582.1061 Lactic acid. 582.1069 Malic acid. 582.1073 Phosphoric acid. 582.1077 Potassium acid tartrate. 582.1087 Sodium acid pyrophosphate. 582.1091 Succinic acid. 582.1095 Sulfuric acid. 582.1099 Tartaric acid. 582.1125 Aluminum sulfate. 582.1127 Aluminum ammonium sulfate. 582.1129 Aluminum potassium sulfate. 582.1131 Aluminum sodium sulfate. 582.1135 Ammonium bicarbonate. 582.1137 Ammonium carbonate. 582.1139 Ammonium hydroxide. 582.1141 Ammonium phosphate. 582.1143 Ammonium sulfate. 582.1155 Bentonite. 582.1165 Butane. 582.1191 Calcium carbonate. 582.1193 Calcium chloride. 582.1195 Calcium citrate. 582.1199 Calcium gluconate. 582.1205 Calcium hydroxide. 582.1207 Calcium lactate. 582.1210 Calcium oxide. 582.1217 Calcium phosphate. 582.1235 Caramel. 582.1240 Carbon dioxide. 582.1275 Dextrans. 582.1320 Glycerin. 582.1324 Glyceryl monostearate. 582.1355 Helium. 582.1366 Hydrogen peroxide. 582.1400 Lecithin. 582.1425 Magnesium carbonate. 582.1428 Magnesium hydroxide. 582.1431 Magnesium oxide. 582.1480 Methylcellulose. 582.1500 Monoammonium glutamate. 582.1516 Monopotassium glutamate. 582.1540 Nitrogen. 582.1585 Papain. 582.1613 Potassium bicarbonate. 582.1619 Potassium carbonate. 582.1625 Potassium citrate. 582.1631 Potassium hydroxide. 582.1643 Potassium sulfate. 582.1655 Propane. 582.1666 Propylene glycol. 582.1685 Rennet. 582.1711 Silica aerogel. 582.1721 Sodium acetate. 582.1736 Sodium bicarbonate. 582.1742 Sodium carbonate. 582.1745 Sodium carboxymethylcellulose. 582.1748 Sodium caseinate. 582.1751 Sodium citrate. 582.1763 Sodium hydroxide. 582.1775 Sodium pectinate. 582.1778 Sodium phosphate. 582.1781 Sodium aluminum phosphate. 582.1792 Sodium sesquicarbonate. 582.1804 Sodium potassium tartrate. 582.1810 Sodium tripolyphosphate. 582.1901 Triacetin. VerDate Aug<31>2005 09:04 Apr 25, 2006 Jkt 208070 PO 00000 Frm 00539 Fmt 8010 Sfmt 8010 Y:\SGML\208070.XXX 208070
Transcript
529
Food and Drug Administration, HHS Pt. 582
(a) Energy sources. Ionizing radiation is limited to gamma rays from sealed units of cobalt-60.
(b) Limitation. The ionizing radiation is used for feed or feed ingredients that do not contain drugs.
(c) Use. Ionizing radiation is used as a single treatment for rendering com-plete poultry diets or poultry feed in-gredients salmonella negative as fol-lows:
(1) Minimum dose 2.0 kiloGrays (kGy) (0.2 megarad (Mrad)); maximum dose 25 kGy (2.5 megarads Mrad). The absorbed dose of irradiation is to be based on ini-tial concentration of salmonella using the relationship that 1.0 kGy (0.1 Mrad) reduces salmonella concentration by one log cycle (one decimal reduction).
(2) Feeds treated by irradiation should be formulated to account for nutritional loss.
(3) If an irradiated feed ingredient is less than 5 percent of the final product, the final product can be irradiated without being considered to be re-irradiated.
[60 FR 50099, Sept. 28, 1995]
PART 582—SUBSTANCES GENERALLY RECOGNIZED AS SAFE
Subpart A—General Provisions
Sec. 582.1 Substances that are generally recog-
nized as safe. 582.10 Spices and other natural seasonings
and flavorings. 582.20 Essential oils, oleoresins (solvent-
free), and natural extractives (including distillates).
582.30 Natural substances used in conjunc-tion with spices and other natural seasonings and flavorings.
582.40 Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings.
582.50 Certain other spices, seasonings, es-sential oils, oleoresins, and natural ex-tracts.
582.60 Synthetic flavoring substances and adjuvants.
582.80 Trace minerals added to animal feeds. 582.99 Adjuvants for pesticide chemicals.
§ 582.1 Substances that are generally recognized as safe.
(a) It is impracticable to list all sub-stances that are generally recognized
as safe for their intended use. However, by way of illustration, the Commis-sioner regards such common food in-gredients as salt, pepper, sugar, vin-egar, baking powder, and monosodium glutamate as safe for their intended use. The lists in subparts B through H of this part include additional sub-stances that, when used for the pur-poses indicated, in accordance with good manufacturing or feeding prac-tice, are regarded by the Commissioner as generally recognized as safe for such uses.
(b) For the purposes of this section, good manufacturing or feeding practice shall be defined to include the fol-lowing restrictions:
(1) The quantity of a substance added to animal food does not exceed the amount reasonably required to accom-plish its intended physical, nutritional, or other technical effect in food; and
(2) The quantity of a substance that becomes a component of animal food as a result of its use in the manufac-turing, processing, or packaging of food, and which is not intended to ac-complish any physical or other tech-nical effect in the food itself, shall be reduced to the extent reasonably pos-sible.
(3) The substance is of appropriate grade and is prepared and handled as a food ingredient. Upon request the Com-missioner 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 pu-rity for use in food and would generally be regarded as safe for the purpose in-tended, 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 sup-plement to the diet for animals.
(d) Substances that are generally rec-ognized as safe for their intended use within the meaning of section 409 of the Act are listed in subparts B through H of this part. When the status of a substance has been reevaluated and affirmed as GRAS or deleted from subparts B through H of this part, an appropriate explanation will be noted,
e.g., ‘‘affirmed as GRAS,’’ ‘‘food addi-tive regulation,’’ ‘‘interim food addi-tive regulation,’’ or ‘‘prohibited from use in food,’’ with a reference to the appropriate new regulation. Such nota-tion will apply only to the specific use covered by the review, e.g., direct ani-mal food use and/or indirect animal food use and/or animal feed use and will not affect its status for other uses not specified in the referenced regula-
tion, pending a specific review of such other uses.
§ 582.10 Spices and other natural seasonings and flavorings.
Spices and other natural seasonings and flavorings that are generally rec-ognized 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 Roman ................................ Anthemis nobilis L. Camomile (chamomile), German or Hungarian .......................... Matricaria chamomilla L. 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. Cloves .......................................................................................... Eugenia caryophyllata Thunb. Coriander ..................................................................................... Coriandrum sativum L. Cumin (cummin) .......................................................................... Cuminum cyminum L. Cumin, black (black caraway) ..................................................... Nigella sativa L. Dill ................................................................................................ Anethum graveolens L. Elder flowers ................................................................................ Sambucus canadensis L. Fennel, common .......................................................................... Foeniculum vulgare Mill. Fennel, sweet (finocchio, Florence fennel) ................................. Foeniculum vulgare Mill. var. duice (DC.) Alex. Fenugreek .................................................................................... Trigonella foenum-graecum L. Galanga (galangal) ...................................................................... Alpina officinarum Hance. Garlic ........................................................................................... Allium sativum L. Geranium ..................................................................................... Pelargonium spp. Ginger .......................................................................................... Zingiber officinale Rosc. Glycyrrhiza ................................................................................... Glycyrrhiza glabra L. and other spp. of Glycyrrhiza. Grains of paradise ....................................................................... Amomum melegueta Rosc. Horehound (hoarhound) .............................................................. Marrubium vulgare L. Horseradish ................................................................................. Armoracia lapathifolia Gilib. Hyssop ......................................................................................... Hyssopus officinalis L. Lavender ...................................................................................... Lavandula officinalis Chaix. Licorice ........................................................................................ Glycyrrhiza glabra L. and other spp. of Glycyrrhiza. 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, Mexican sage, origan) Lippia spp. 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 .................................................................................. Papaver somniferum L. Pot marigold ................................................................................ Calendula officinalis L. Pot marjoram ............................................................................... Majorana onites (L.) Benth. Rosemary .................................................................................... Rosmarinus officinalis L. Rue .............................................................................................. Ruta graveolens 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.
Essential oils, oleoresins (solvent- free), and natural extractives (includ-
ing distillates) that are generally rec-ognized 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 acid) ........................................ Prunus amygdalus Batsch, Prunus 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. 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 acid) ......................................... Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus
persica (L.) Batsch. Bois de rose ................................................................................ Aniba rosaeodora Ducke. Cacao .......................................................................................... Theobroma cacao L. Camomile (chamomile) flowers, Hungarian ................................ Matricaria chamomilla L. Camomile (chamomile) flowers, Roman or English .................... Anthemis nobilis L. 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.
Mate 1 .......................................................................................... Ilex paraguariensis St. Hil. Melissa (see balm). Menthol ........................................................................................ Mentha spp. Menthyl acetate ........................................................................... Do. Molasses (extract) ....................................................................... Saccharum 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 ............................................................................... Piper nigrum L. 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 ................................................................................. Primenta 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 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. Rue .............................................................................................. Ruta graveolens 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. Tannic acid .................................................................................. Nutgalls of Quercus infectoria Oliver and related spp. of
Quercus. Also in many other plants. 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 .......................................................................................... 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.
§ 582.30 Natural substances used in conjunction with spices and other natural seasonings and flavorings.
Natural substances used in conjunc-tion with spices and other natural
seasonings and flavorings that are gen-erally recognized as safe for their in-tended use, within the meaning of sec-tion 409 of the act, are as follows:
Common name Botanical name of plant source
Algae, brown (kelp) ..................................................................... Laminaria spp. and Nereocystis spp. Algae, red .................................................................................... Porphyra spp. and Rhodymenia palmata (L.) Grev. Dulse ............................................................................................ Rhodymenia palmata (L.)
§ 582.40 Natural extractives (solvent- free) used in conjunction with spices, seasonings, and flavorings.
Natural extractives (solvent-free) used in conjunction with spices,
seasonings, and flavorings that are generally recognized as safe for their intended use, within the meaning of section 409 of the act, are as follows:
Common name Botanical name of plant source
Algae, brown ................................................................................ Laminaria spp. and Nereocystis spp. Algae, red .................................................................................... Porphyra spp. and Rhodymenia palmata (L.) Grev. Apricot kernel (persic oil) ............................................................. Prunus armeniaca L. Dulse ............................................................................................ Rhodymenia palmata (L.) Grev. Kelp (see algae, brown). 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.
§ 582.50 Certain other spices, seasonings, essential oils, oleoresins, and natural extracts.
Certain other spices, seasonings, es-sential oils, oleoresins, and natural ex-
tracts 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, 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.
§ 582.60 Synthetic flavoring substances and adjuvants.
Synthetic flavoring substances and adjuvants that are generally recog-nized as safe for their intended use, within the meaning of section 409 of the act, are as follows:
These substances added to animal feeds as nutritional dietary supple-ments are generally recognized as safe when added at levels consistent with good feeding practice. 1
Iron ............................. Iron ammonium citrate. Iron carbonate. Iron chloride. Iron gluconate. Iron oxide. Iron phosphate. Iron pyrophosphate. Iron sulfate. Reduced iron.
Adjuvants, identified and used in ac-cordance with 40 CFR 180.1001(c) and (d), which are added to pesticide use di-lutions by a grower or applicator prior to application to the raw agricultural commodity, are exempt from the re-quirement of tolerances under section 409 of the act.
Subpart B—General Purpose Food Additives
§ 582.1005 Acetic acid. (a) Product. Acetic acid. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
nation. This substance is generally rec-ognized as safe when used as a buffer and neutralizing agent in accordance with good manufacturing or feeding practice.
§ 582.1033 Citric acid. (a) Product. Citric acid. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
nation. This substance is generally rec-ognized as safe when used as a buffer and neutralizing agent in accordance with good manufacturing or feeding practice.
§ 582.1061 Lactic acid. (a) Product. Lactic acid. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.1666 Propylene glycol. (a) Product. Propylene glycol. (b) Conditions of use. This substance
is generally recognized as safe (except in cat food) when used in accordance with good manufacturing or feeding practice.
[41 FR 38657, Sept. 10, 1976, as amended at 61 FR 19544, May 2, 1996]
§ 582.1685 Rennet. (a) Product. Rennet (rennin). (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.1711 Silica aerogel. (a) Product. Silica aerogel as a finely
powdered microcellular silica foam having a minimum silica content of 89.5 percent.
(b) [Reserved] (c) Limitations, restrictions, or expla-
nation. This substance is generally rec-ognized as safe when used as a compo-nent of antifoaming agents in accord-ance with good manufacturing or feed-ing practice.
§ 582.1721 Sodium acetate. (a) Product. Sodium acetate. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.1736 Sodium bicarbonate. (a) Product. Sodium bicarbonate. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.1742 Sodium carbonate. (a) Product. Sodium carbonate. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.1745 Sodium carboxymethylcellulose.
(a) Product. Sodium carboxymethyl- cellulose is the sodium salt of carboxymethylcellulose not less than 99.5 percent on a dry-weight basis, with maximum substitution of 0.95
carboxymethyl groups per anhydroglucose unit, and with a min-imum viscosity of 25 centipoises for 2 percent by weight aqueous solution at 25 °C.
(b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.1748 Sodium caseinate. (a) Product. Sodium caseinate. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.1751 Sodium citrate. (a) Product. Sodium citrate. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.1763 Sodium hydroxide. (a) Product. Sodium hydroxide. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.1775 Sodium pectinate. (a) Product. Sodium pectinate. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
cate. (b) Tolerance. 2 percent. (c) Limitations, restrictions, or expla-
nation. This substance is generally rec-ognized as safe when used in table salt
in accordance with good manufacturing or feeding practice.
§ 582.2227 Calcium silicate.
(a) Product. Calcium silicate. (b) Tolerance. 2 percent and 5 percent. (c) Limitations, restrictions, or expla-
nation. This substance is generally rec-ognized as safe when used at levels not exceeding 2 percent in table salt and 5 percent in baking powder in accordance with good manufacturing or feeding practice.
(b) Tolerance. This substance is gen-erally recognized as safe for use at a level not exceeding 2 percent in accord-ance with good manufacturing or feed-ing practice.
(b) Tolerance. This substance is gen-erally recognized as safe for use at a level not exceeding 2 percent in accord-ance with good manufacturing or feed-ing practice.
(b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.3021 Benzoic acid. (a) Product. Benzoic acid. (b) Tolerance. This substance is gen-
erally recognized as safe for use at a level not exceeding 0.1 percent in ac-cordance with good manufacturing or feeding practice.
§ 582.3041 Erythorbic acid. (a) Product. Erythorbic acid. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.3081 Propionic acid. (a) Product. Propionic acid. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.3089 Sorbic acid. (a) Product. Sorbic acid. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.3109 Thiodipropionic acid. (a) Product. Thiodipropionic acid. (b) Tolerance. This substance is gen-
erally recognized as safe for use in food when the total content of antioxidants is not over 0.02 percent of fat or oil content including essential (volatile) oil content of the food, provided the substance is used in accordance with good manufacturing or feeding prac-tice.
§ 582.3149 Ascorbyl palmitate. (a) Product. Ascorbyl palmitate. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
erally 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 sub-stance is used in accordance with good manufacturing or feeding practice.
erally 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 sub-stance is used in accordance with good manufacturing or feeding practice.
§ 582.3189 Calcium ascorbate. (a) Product. Calcium ascorbate. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.3221 Calcium propionate. (a) Product. Calcium propionate. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.3225 Calcium sorbate. (a) Product. Calcium sorbate. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
thiodipropionate. (b) Tolerance. This substance is gen-
erally recognized as safe for use in food when the total content of antioxidants is not over 0.02 percent of fat or oil content, including essential (volatile) oil content of the food, provided the substance is used in accordance with good manufacturing or feeding prac-tice.
nation. This substance is generally rec-ognized as safe when used in accord-ance with good manufacturing or feed-ing practice, except that it is not used in meats or in food recognized as source of vitamin B1.
nation. This substance is generally rec-ognized as safe when used in accord-ance with good manufacturing or feed-ing practice, except that it is not used in meats or in food recognized as source of vitamin B1.
§ 582.3640 Potassium sorbate. (a) Product. Potassium sorbate. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.3660 Propyl gallate. (a) Product. Propyl gallate. (b) Tolerance. This substance is gen-
erally recognized as safe for use in food when the total content of antioxidants is not over 0.02 percent of fat or oil content, including essential (volatile) oil content of the food, provided the substance is used in accordance with good manufacturing or feeding prac-tice.
nation. This substance is generally rec-ognized as safe when used in accord-ance with good manufacturing or feed-ing practice, except that it is not used in meats or in food recognized as source of vitamin B1.
nation. This substance is generally rec-ognized as safe when used in accord-ance with good manufacturing or feed-ing practice, except that it is not used in meats or in food recognized as source of vitamin B1.
§ 582.3784 Sodium propionate.
(a) Product. Sodium propionate. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.3795 Sodium sorbate.
(a) Product. Sodium sorbate. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
1 Amino acids listed in this subpart may be free hydrochloride salt, hydrated, or anhy-drous form, where applicable.
(c) Limitations, restrictions, or expla-nation. This substance is generally rec-ognized as safe when used in accord-ance with good manufacturing or feed-ing practice, except that it is not used in meats or in food recognized as source of vitamin B1.
§ 582.3845 Stannous chloride. (a) Product. Stannous chloride. (b) Tolerance. This substance is gen-
erally recognized as safe for use at a level not exceeding 0.0015 percent cal-culated as tin in accordance with good manufacturing or feeding practice.
nation. This substance is generally rec-ognized as safe when used in accord-ance with good manufacturing or feed-ing practice, except that it is not used in meats or in food recognized as source of vitamin B1.
§ 582.3890 Tocopherols. (a) Product. Tocopherols. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
nation. This substance is generally rec-ognized as safe when used in table salt as a source of dietary iodine in accord-ance with good manufacturing or feed-ing practice.
§ 582.5650 Proline. (a) Product. Proline (L- and DL-
forms). (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.7351 Gum tragacanth.
(a) Product. Tragacanth (gum tragacanth).
(b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.7610 Potassium alginate.
(a) Product. Potassium alginate. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
§ 582.7724 Sodium alginate.
(a) Product. Sodium alginate. (b) Conditions of use. This substance
is generally recognized as safe when used in accordance with good manufac-turing or feeding practice.
PART 584—FOOD SUBSTANCES AF-FIRMED AS GENERALLY RECOG-NIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS
Subpart A [Reserved]
Subpart B—Listing of Specific Substances Affirmed as GRAS
Sec. 584.200 Ethyl alcohol containing ethyl ace-
tate. 584.700 Hydrophobic silicas.
AUTHORITY: 21 U.S.C. 321, 342, 348, 371.
Subpart A [Reserved]
Subpart B—Listing of Specific Substances Affirmed as GRAS
§ 584.200 Ethyl alcohol containing ethyl acetate.
The feed additive ethyl alcohol con-taining ethyl acetate meets the re-quirement of 27 CFR 212.45, being not less than 92.5 percent ethyl alcohol, each 100 gallons having had added the equivalent of 4.25 gallons of 100 percent ethyl acetate. It is used in accordance with good feeding practices in rumi-nant feed supplements as a source of added energy.
