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Electronic Code of Federal Regulations

e-CFR data is current as of December 12, 2019

Title 21Chapter ISubchapter EPart 582 → Subpart F


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


Subpart F—Nutrients and/or Dietary Supplements1


Contents
§582.5013   Ascorbic acid.
§582.5017   Aspartic acid.
§582.5049   Aminoacetic acid.
§582.5065   Linoleic acid.
§582.5118   Alanine.
§582.5145   Arginine.
§582.5159   Biotin.
§582.5191   Calcium carbonate.
§582.5195   Calcium citrate.
§582.5201   Calcium glycerophosphate.
§582.5210   Calcium oxide.
§582.5212   Calcium pantothenate.
§582.5217   Calcium phosphate.
§582.5223   Calcium pyrophosphate.
§582.5230   Calcium sulfate.
§582.5245   Carotene.
§582.5250   Choline bitartrate.
§582.5252   Choline chloride.
§582.5260   Copper gluconate.
§582.5271   Cysteine.
§582.5273   Cystine.
§582.5301   Ferric phosphate.
§582.5304   Ferric pyrophosphate.
§582.5306   Ferric sodium pyrophosphate.
§582.5308   Ferrous gluconate.
§582.5311   Ferrous lactate.
§582.5315   Ferrous sulfate.
§582.5361   Histidine.
§582.5370   Inositol.
§582.5375   Iron reduced.
§582.5381   Isoleucine.
§582.5406   Leucine.
§582.5411   Lysine.
§582.5431   Magnesium oxide.
§582.5434   Magnesium phosphate.
§582.5443   Magnesium sulfate.
§582.5446   Manganese chloride.
§582.5449   Manganese citrate.
§582.5452   Manganese gluconate.
§582.5455   Manganese glycerophosphate.
§582.5458   Manganese hypophosphite.
§582.5461   Manganese sulfate.
§582.5464   Manganous oxide.
§582.5470   Mannitol.
§582.5475   Methionine.
§582.5477   Methionine hydroxy analog and its calcium salts.
§582.5530   Niacin.
§582.5535   Niacinamide.
§582.5580   D-Pantothenyl alcohol.
§582.5590   Phenylalanine.
§582.5622   Potassium chloride.
§582.5628   Potassium glycerophosphate.
§582.5634   Potassium iodide.
§582.5650   Proline.
§582.5676   Pyridoxine hydrochloride.
§582.5695   Riboflavin.
§582.5697   Riboflavin-5-phosphate.
§582.5701   Serine.
§582.5772   Sodium pantothenate.
§582.5778   Sodium phosphate.
§582.5835   Sorbitol.
§582.5875   Thiamine hydrochloride.
§582.5878   Thiamine mononitrate.
§582.5881   Threonine.
§582.5890   Tocopherols.
§582.5892   a-Tocopherol acetate.
§582.5915   Tryptophane.
§582.5920   Tyrosine.
§582.5925   Valine.
§582.5930   Vitamin A.
§582.5933   Vitamin A acetate.
§582.5936   Vitamin A palmitate.
§582.5945   Vitamin B2.
§582.5950   Vitamin D2.
§582.5953   Vitamin D2.
§582.5985   Zinc chloride.
§582.5988   Zinc gluconate.
§582.5991   Zinc oxide.
§582.5994   Zinc stearate.
§582.5997   Zinc sulfate.

§582.5013   Ascorbic acid.

(a) Product. Ascorbic acid.

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

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

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§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.

§582.5945   Vitamin B2.

(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.

§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.

§582.5953   Vitamin D2.

(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.

§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.

§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.

§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.

§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.

§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.

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