CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR582]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 582 SUBSTANCES GENERALLY RECOGNIZED AS SAFE

Subpart B - General Purpose Food Additives

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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]

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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 deg.C.

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

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Authority: 21 U.S.C. 321, 342, 348, 371.
Source: 41 FR 38657, Sept. 10, 1976, unless otherwise noted.