21 C.F.R. Subpart F—Nutrients and/or Dietary Supplements1
Title 21 - Food and Drugs
(a) Product. Ascorbic acid. 1 Amino 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. (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. (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. (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. (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. (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. (a) Product. Biotin. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice. (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. (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. (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. (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. (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. (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. (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. (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. (a) Product. Carotene. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice. (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. (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. (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. (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. (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. (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. (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. (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. (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. (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. (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. (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. (a) Product. Inositol. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice. (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. (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. (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. (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. (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. (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. (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. (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. (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. (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. (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. (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. (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. (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. (a) Product. Mannitol. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice. (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. (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. (a) Product. Niacin. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice. (a) Product. Niacinamide. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice. (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. (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. (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. (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. (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. (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. (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. (a) Product. Riboflavin. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice. (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. (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. (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. (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. (a) Product. Sorbitol. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice. (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. (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. (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. (a) Product. Tocopherols. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice. (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. (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. (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. (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. (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. (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. (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. (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. (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. (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. (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. (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. (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. (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. (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.
Title 21: Food and Drugs
PART 582—SUBSTANCES GENERALLY RECOGNIZED AS SAFE
Subpart F—Nutrients and/or Dietary Supplements1
§ 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
§ 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 B12.
§ 582.5950 Vitamin D2.
§ 582.5953 Vitamin D3.
§ 582.5985 Zinc chloride.
§ 582.5988 Zinc gluconate.
§ 582.5991 Zinc oxide.
§ 582.5994 Zinc stearate.
§ 582.5997 Zinc sulfate.

