21 C.F.R. Subpart B—General Purpose Food Additives


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 582—SUBSTANCES GENERALLY RECOGNIZED AS SAFE

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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 manufacturing or feeding practice.

§ 582.1009   Adipic acid.

(a) Product. Adipic 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 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 manufacturing or feeding practice.

§ 582.1057   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 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 manufacturing or feeding practice.

§ 582.1069   Malic acid.

(a) Product. Malic acid.

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

§ 582.1073   Phosphoric acid.

(a) Product. Phosphoric acid.

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

§ 582.1077   Potassium acid tartrate.

(a) Product. Potassium acid tartrate.

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

§ 582.1087   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 or feeding practice.

§ 582.1091   Succinic acid.

(a) Product. Succinic acid.

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

§ 582.1095   Sulfuric acid.

(a) Product. Sulfuric acid.

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

§ 582.1099   Tartaric acid.

(a) Product. Tartaric acid.

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

§ 582.1125   Aluminum sulfate.

(a) Product. Aluminum sulfate.

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

§ 582.1127   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 or feeding practice.

§ 582.1129   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 or feeding practice.

§ 582.1131   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 or feeding practice.

§ 582.1135   Ammonium bicarbonate.

(a) Product. Ammonium bicarbonate.

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

§ 582.1137   Ammonium carbonate.

(a) Product. Ammonium carbonate.

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

§ 582.1139   Ammonium hydroxide.

(a) Product. Ammonium hydroxide.

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

§ 582.1141   Ammonium phosphate.

(a) Product. Ammonium phosphate (mono- and dibasic).

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

§ 582.1143   Ammonium sulfate.

(a) Product. Ammonium sulfate.

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

§ 582.1155   Bentonite.

(a) Product. Bentonite.

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

§ 582.1165   Butane.

(a) Product. Butane.

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

§ 582.1191   Calcium carbonate.

(a) Product. Calcium carbonate.

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

§ 582.1193   Calcium chloride.

(a) Product. Calcium chloride.

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

§ 582.1195   Calcium citrate.

(a) Product. Calcium citrate.

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

§ 582.1199   Calcium gluconate.

(a) Product. Calcium gluconate.

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

§ 582.1205   Calcium hydroxide.

(a) Product. Calcium hydroxide.

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

§ 582.1207   Calcium lactate.

(a) Product. Calcium lactate.

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

§ 582.1210   Calcium oxide.

(a) Product. Calcium oxide.

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

§ 582.1217   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 or feeding practice.

§ 582.1235   Caramel.

(a) Product. Caramel.

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

§ 582.1240   Carbon dioxide.

(a) Product. Carbon dioxide.

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

§ 582.1275   Dextrans.

(a) Product. Dextrans of average molecular weight below 100,000.

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

§ 582.1320   Glycerin.

(a) Product. Glycerin.

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

§ 582.1324   Glyceryl monostearate.

(a) Product. Glyceryl monostearate.

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

§ 582.1355   Helium.

(a) Product. Helium.

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

§ 582.1366   Hydrogen peroxide.

(a) Product. Hydrogen peroxide.

(b) [Reserved]

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

§ 582.1400   Lecithin.

(a) Product. Lecithin.

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

§ 582.1425   Magnesium carbonate.

(a) Product. Magnesium carbonate.

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

§ 582.1428   Magnesium hydroxide.

(a) Product. Magnesium hydroxide.

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

§ 582.1431   Magnesium oxide.

(a) Product. Magnesium oxide.

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

§ 582.1480   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 or feeding practice.

§ 582.1500   Monoammonium glutamate.

(a) Product. Monoammonium glutamate.

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

§ 582.1516   Monopotassium glutamate.

(a) Product. Monopotassium glutamate.

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

§ 582.1540   Nitrogen.

(a) Product. Nitrogen.

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

§ 582.1585   Papain.

(a) Product. Papain.

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

§ 582.1613   Potassium bicarbonate.

(a) Product. Potassium bicarbonate.

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

§ 582.1619   Potassium carbonate.

(a) Product. Potassium carbonate.

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

§ 582.1625   Potassium citrate.

(a) Product. Potassium citrate.

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

§ 582.1631   Potassium hydroxide.

(a) Product. Potassium hydroxide.

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

§ 582.1643   Potassium sulfate.

(a) Product. Potassium sulfate.

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

§ 582.1655   Propane.

(a) Product. Propane.

(b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing 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 manufacturing 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 explanation. This substance is generally recognized as safe when used as a component of antifoaming agents in accordance with good manufacturing or feeding 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 manufacturing 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 manufacturing 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 manufacturing 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 minimum viscosity of 25 centipoises for 2 percent by weight aqueous solution at 25 °C.

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

§ 582.1778   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 or feeding practice.

§ 582.1781   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 or feeding practice.

§ 582.1792   Sodium sesquicarbonate.

(a) Product. Sodium sesquicarbonate.

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

§ 582.1804   Sodium potassium tartrate.

(a) Product. Sodium potassium tartrate.

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

§ 582.1810   Sodium tripolyphosphate.

(a) Product. Sodium tripolyphosphate.

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

§ 582.1901   Triacetin.

(a) Product. Triacetin (glyceryl triacetate).

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

§ 582.1973   Beeswax.

(a) Product. Beeswax (yellow wax).

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

§ 582.1975   Bleached beeswax.

(a) Product. Bleached beeswax (white wax).

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

§ 582.1978   Carnauba wax.

(a) Product. Carnauba wax.

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

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