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 F - Nutrients and/or Dietary Supplements ¹

Sec. 582.5013 Ascorbic acid.

(a) Product. Ascorbic acid.

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

¹ Amino acids listed in this subpart may be free hydrochloride salt, hydrated, or anhydrous form, where applicable.

Sec. 582.5017 Aspartic acid.

(a) Product. Aspartic acid (L- and DL-forms).

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

Sec. 582.5049 Aminoacetic acid.

(a) Product. Glycine (aminoacetic acid).

(b) [Reserved]

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

Sec. 582.5065 Linoleic acid.

(a) Product. Linoleic acid prepared from edible fats and oils and free from chick-edema factor.

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

Sec. 582.5118 Alanine.

(a) Product. Alanine (L- and DL-forms).

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

Sec. 582.5145 Arginine.

(a) Product. Arginine (L- and DL-forms).

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

Sec. 582.5159 Biotin.

(a) Product. Biotin.

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

Sec. 582.5191 Calcium carbonate.

(a) Product. Calcium carbonate.

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

Sec. 582.5195 Calcium citrate.

(a) Product. Calcium citrate.

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

Sec. 582.5201 Calcium glycerophosphate.

(a) Product. Calcium glycerophosphate.

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

Sec. 582.5210 Calcium oxide.

(a) Product. Calcium oxide.

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

Sec. 582.5212 Calcium pantothenate.

(a) Product. Calcium pantothenate.

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

Sec. 582.5217 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 or feeding practice.

Sec. 582.5223 Calcium pyrophosphate.

(a) Product. Calcium pyrophosphate.

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

Sec. 582.5230 Calcium sulfate.

(a) Product. Calcium sulfate.

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

Sec. 582.5245 Carotene.

(a) Product. Carotene.

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

Sec. 582.5250 Choline bitartrate.

(a) Product. Choline bitartrate.

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

Sec. 582.5252 Choline chloride.

(a) Product. Choline chloride.

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

Sec. 582.5260 Copper gluconate.

(a) Product. Copper gluconate.

(b) Tolerance. This substance is generally recognized as safe for use at a level not exceeding 0.005 percent in accordance with good manufacturing or feeding practice.

Sec. 582.5271 Cysteine.

(a) Product. Cysteine (L-forms).

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

Sec. 582.5273 Cystine.

(a) Product. Cystine (L- and DL-forms).

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

Sec. 582.5301 Ferric phosphate.

(a) Product. Ferric phosphate.

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

Sec. 582.5304 Ferric pyrophosphate.

(a) Product. Ferric pyrophosphate.

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

Sec. 582.5306 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 or feeding practice.

Sec. 582.5308 Ferrous gluconate.

(a) Product. Ferrous gluconate.

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

Sec. 582.5311 Ferrous lactate.

(a) Product. Ferrous lactate.

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

Sec. 582.5315 Ferrous sulfate.

(a) Product. Ferrous sulfate.

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

Sec. 582.5361 Histidine.

(a) Product. Histidine (L- and DL-forms).

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

Sec. 582.5370 Inositol.

(a) Product. Inositol.

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

Sec. 582.5375 Iron reduced.

(a) Product. Iron reduced.

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

Sec. 582.5381 Isoleucine.

(a) Product. Isoleucine (L- and DL-forms).

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

Sec. 582.5406 Leucine.

(a) Product. Leucine (L- and DL-forms).

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

Sec. 582.5411 Lysine.

(a) Product. Lysine (L- and DL-forms).

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

Sec. 582.5431 Magnesium oxide.

(a) Product. Magnesium oxide.

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

Sec. 582.5434 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 or feeding practice.

Sec. 582.5443 Magnesium sulfate.

(a) Product. Magnesium sulfate.

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

Sec. 582.5446 Manganese chloride.

(a) Product. Manganese chloride.

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

Sec. 582.5449 Manganese citrate.

(a) Product. Manganese citrate.

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

Sec. 582.5452 Manganese gluconate.

(a) Product. Manganese gluconate.

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

Sec. 582.5455 Manganese glycerophosphate.

(a) Product. Manganese glycerophosphate.

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

Sec. 582.5458 Manganese hypophosphite.

(a) Product. Manganese hypophosphite.

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

Sec. 582.5461 Manganese sulfate.

(a) Product. Manganese sulfate.

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

Sec. 582.5464 Manganous oxide.

(a) Product. Manganous oxide.

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

Sec. 582.5470 Mannitol.

(a) Product. Mannitol.

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

Sec. 582.5475 Methionine.

(a) Product. Methionine.

(b) [Reserved]

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

Sec. 582.5477 Methionine hydroxy analog and its calcium salts.

(a) Product. Methionine hydroxy analog and its calcium salts.

(b) [Reserved]

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

Sec. 582.5530 Niacin.

(a) Product. Niacin.

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

Sec. 582.5535 Niacinamide.

(a) Product. Niacinamide.

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

Sec. 582.5580 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 or feeding practice.

Sec. 582.5590 Phenylalanine.

(a) Product. Phenylalanine (L- and DL-forms).

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

Sec. 582.5622 Potassium chloride.

(a) Product. Potassium chloride.

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

Sec. 582.5628 Potassium glycerophosphate.

(a) Product. Potassium glycerophosphate.

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

Sec. 582.5634 Potassium iodide.

(a) Product. Potassium iodide.

(b) Tolerance. 0.01 percent.

(c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in table salt as a source of dietary iodine in accordance with good manufacturing or feeding practice.

Sec. 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 manufacturing or feeding practice.

Sec. 582.5676 Pyridoxine hydrochloride.

(a) Product. Pyridoxine hydrochloride.

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

Sec. 582.5695 Riboflavin.

(a) Product. Riboflavin.

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

Sec. 582.5697 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 or feeding practice.

Sec. 582.5701 Serine.

(a) Product. Serine (L- and DL-forms).

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

Sec. 582.5772 Sodium pantothenate.

(a) Product. Sodium pantothenate.

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

Sec. 582.5778 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. 582.5835 Sorbitol.

(a) Product. Sorbitol.

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

Sec. 582.5875 Thiamine hydrochloride.

(a) Product. Thiamine hydrochloride.

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

Sec. 582.5878 Thiamine mononitrate.

(a) Product. Thiamine mononitrate.

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

Sec. 582.5881 Threonine.

(a) Product. Threonine (L- and DL-forms).

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

Sec. 582.5890 Tocopherols.

(a) Product. Tocopherols.

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

Sec. 582.5892 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 or feeding practice.

Sec. 582.5915 Tryptophane.

(a) Product. Tryptophane (L- and DL-forms).

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

Sec. 582.5920 Tyrosine.

(a) Product. Tyrosine (L- and DL-forms).

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

Sec. 582.5925 Valine.

(a) Product. Valine (L- and DL-forms).

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

Sec. 582.5930 Vitamin A.

(a) Product. Vitamin A.

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

Sec. 582.5933 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 or feeding practice.

Sec. 582.5936 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 or feeding practice.

Sec. 582.5945 Vitamin B12.

(a) Product. Vitamin B12.

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

Sec. 582.5950 Vitamin D2.

(a) Product. Vitamin D2.

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

Sec. 582.5953 Vitamin D3.

(a) Product. Vitamin D3.

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

Sec. 582.5985 Zinc chloride.

(a) Product. Zinc chloride.

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

Sec. 582.5988 Zinc gluconate.

(a) Product. Zinc gluconate.

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

Sec. 582.5991 Zinc oxide.

(a) Product. Zinc oxide.

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

Sec. 582.5994 Zinc stearate.

(a) Product. Zinc stearate prepared from stearic acid free from chick-edema factor.

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

Sec. 582.5997 Zinc sulfate.

(a) Product. Zinc sulfate.

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

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