Cal. Code Regs. tit. 3 § 2806

Current through Register 2025 Notice Reg. No. 2, January 10, 2025
Section 2806 - Vitamins
(a) Betaine (hydrochloride or anhydrous) is the crystalline chloride of betaine or anhydrous betaine; a partial replacement for choline.
(b) Cholecalciferol (D-Activated Animal Sterol) is obtained by activation of a sterol fraction of animal origin with ultra-violet light or other means. For label identification it may be followed with the parenthetical phrase (Source of Vitamin D3).
(c) Cod Liver Oil is the oil obtained from the livers of gadus morrhuae or other species of the family gadidae, either or both. It must contain not less than 385,900 International Units of vitamin A per pound (850 units per gram) and not less than 29,510 International Chick Units of vitamin D per pound (65 units per gram).
(d) Cod Liver Oil with Added Vitamins A and D is the product consisting of cod liver oil to which has been added vitamins A and D. The product must contain not less than 136,000 International Chick Units of vitamin D per pound (300 per gram).
(e) Ergocalciferol (D-Activated Plant Sterol) is obtained by activation of a sterol fraction of plant origin with ultra-violet light or other means. For label identification it may be followed with the parenthetical phrase (Source of Vitamin D2).
(f) Vitamin A and D Oil is an oil of animal or vegetable origin with or without vitamins A and D supplementation for which vitamin potencies are claimed.
(g) Vitamin A Oil is an oil of animal or vegetable origin with or without vitamin A supplementation for which vitamin A potency is claimed.
(h) Vitamin A Supplement is a feeding material used for its vitamin A content. It must contain a minimum of two million International Units of vitamin A per pound. The label must bear a statement of the source of vitamin A and a minimum guarantee of International Units of vitamin A per pound with additional permissive International Units of vitamin A per gram.
(i) Vitamin B12 Supplement is a feeding material used for its vitamin B12 activity. It must contain a minimum vitamin B12 activity of 1.5 milligrams per pound. The term must not be applied to products for which there are accepted names and definitions.
(j) Vitamin D Oil is an oil of animal or vegetable origin with or without vitamin D supplementation for which vitamin D potency is claimed.
(k) Vitamin D2 Supplement is a feeding material used for its vitamin D2 activity. It must contain a minimum of 100,000 International Units of vitamin D2 per pound.
(l) Vitamin D3 Supplement is a feeding material used for its vitamin D3 activity. It must contain a minimum of 100,000 International Chick Units of vitamin D3 per pound.
(m) Vitamin E Supplement is a feeding material used for its vitamin E activity. It must contain a minimum vitamin E activity equal to 10,000 International Units of vitamin E per pound.
(n) Niacin Supplement is a term that may be used in the ingredient list on a feed label of a mixed feed to indicate the addition of either Niacin or Niacinamide. Sources containing only Niacin or Niacinamide must state the source of Niacin on their label.
(o) Riboflavin Supplement is a feeding material used chiefly for its riboflavin content, and must contain not less than 1,000 milligrams of riboflavin per pound. The label must bear a parenthetical statement of origin immediately following this declaration.
(p) 25-hydroxyvitamin D3 (21 CFR 573.550, 584.725). The food additive 25-hydroxyvitamin D3 may be safely used in accordance with the following prescribed conditions:
(1) The additive is used or intended for use as a source of vitamin D3 activity in animal feed or drinking water in accordance with good manufacturing and feeding practices as follows:
(A) In feed or drinking water of chickens not to exceed 69 parts per billion in feed or 34.5 parts per billion in drinking water.
(B) In feed or drinking water of turkeys not to exceed: 92 parts per billion in feed; or in drinking water, 25 parts per billion for turkeys up to three (3) weeks of age, 36 parts per billion for turkeys from four (4) to 11 weeks of age, or 45 parts per billion for turkeys over 11 weeks of age.
(2) The additive consists of not less than 94 percent 25-hydroxyvitamin D3 (9,10-secocholesta-5,7,10(19)-triene-3B, 25-diol).
(3) The additive meets the following specifications:
(A) Not more than one (1) percent of any individual sterol.
(B) Not more than five (5) percent water.
(C) Not more than 20 parts per million lead.
(D) Not more than 20 parts per million aluminum.
(E) Not more than one (1.0) percent solvents and non-detectable levels of 2', 4', 5', 7' tetraiodofluorescin.
(F) Not more than one (1) parts per billion 1,25-dihydroxycholecalciferol.
(4) To assure safe use of the additive, in addition to the other information required by the FD&C, the label and labeling shall contain: The name of the additive. A statement to indicate the maximum use level of 25-hydroxyvitamin D3 must not exceed 69 parts per billion in feed or 34.5 parts per billion in drinking water for chickens. A statement to indicate for turkeys the maximum use level of 25-hydroxyvitamin D3 must not exceed 92 parts per billion in feed; or in drinking water, 25 parts per billion for turkeys up to three (3) weeks of age, 36 parts per billion for turkeys from four (4) to 11 weeks of age, or 45 parts per billion for turkeys over 11 weeks of age. Adequate use directions to ensure that 25-hydroxyvitamin D3 (and all premixes) is uniformly blended throughout the feed or drinking water. An expiration date on all premix labeling. A statement on all premix labeling (feed and drinking water forms) that 25-hydroxyvitamin D3 cannot be used simultaneously in both feed and water.
(q) Additional Officially Recognized Vitamin Ingredients for Animal Feed Use at Nutritional Levels and in Conformity with Current Good Manufacturing Practices.
(1) Ascorbic acid (21 CFR 582.5013). Article or Substance Indicated: Crystalline ascorbic acid commercial feed grade. Status Under Food Additive Amendments: GRAS.
(2) L-Ascorbyl-2-polyphosphate. Article or Substance Indicated: Stabilized ascorbic acid feed grade.
(3) L-Ascorbyl-2-sulfate. Article or Substance Indicated: Stabilized ascorbic acid feed grade. Status Under Food Additive Amendments 21 CFR: Aquatic species (salmon, trout, catfish, shrimp, and tilapia).
(4) Biotin (21 CFR 582.5159). Article or Substance Indicated: Biotin -- commercial feed grade. Status Under Food Additive Amendments: GRAS.
(5) Calcium ascorbate. Article or Substance Indicated: Commercial grade. Status Under Food Additive Amendments: Vitamin C activity in dry feeds (<13 percent moisture) only.
(6) Calcium L-ascorbyl-2-monophosphate. Article or Substance Indicated: Stabilized ascorbic acid feed grade, may be used in the feed of any species provided that it is not promoted for species that do not have a dietary requirement for vitamin C.
(7) Calcium pantothenate (21 CFR 582.5212). Article or Substance Indicated: Crystalline calcium pantothenate -- commercial feed grade. Status Under Food Additive Amendments: GRAS.
(8) Carotene (21 CFR 582.5245). Article or Substance Indicated: The refined crystalline carotene fraction of plants. Status Under Food Additive Amendments: GRAS.
(9) Choline chloride (21 CFR 582.5252). Article or Substance Indicated: Choline chloride -- commercial feed grade. Status Under Food Additive Amendments: GRAS.
(10) Choline pantothenate. Article or Substance Indicated: Crystalline choline pantothenate -- commercial feed grade.
(11) Choline xanthate (21 CFR 573.300). Article or Substance Indicated: Choline xanthate -- commercial feed grade.
(12) Erythorbic acid (Iso ascorbic acid) (21 CFR 582.3041). Article or Substance Indicated: Either the acid or the sodium salt.
(13) Folic acid. Article or Substance Indicated: Crystalline folic acid -- commercial feed grade.
(14) Herring oil. Article or Substance Indicated: The oil extracted from whole parts of herring.
(15) Inositol (21 CFR 582.5370). Article or Substance Indicated: Vitamin B complex vitamin; lipotropic, chemical name -- cyclohexanehexol. Also referred to as i-inostol or meso-inositol. Status Under Food Additive Amendments: GRAS.
(16) Magnesium L-ascorbyl-2-phosphate. Article or Substance Indicated: Stablized ascorbic acid. Status Under Food Additive Amendments: Fish feeds only.
(17) Menadione. Article or Substance Indicated: Crystalline menadione -- commercial feed grade. Status Under Food Additive Amendments: Poultry two (2) to four (4) grams per ton.
(18) Menadione dimethylpyrimidinol bisulfite (21 CFR 573.620). Article or Substance Indicated: Crystalline menadione -- dimethylpyrimidinol bisulfite-commercial feed grade. Status Under Food Additive Amendments: Chicken and turkey feeds at two (2) grams per ton Growing and finishing swine feeds at 10 grams per ton.
(19) Menadione nicotinamide bisulfite (21 CFR 573.625). Article or Substance Indicated: Source of vitamin K activity and supplemental niacin. Status Under Food Additive Amendments: Chicken and turkey feeds at two (2) grams per ton. Growing and finishing swine feeds at 10 grams per ton.
(20) Menadione sodium bisulfite complex. Article or Substance Indicated: The addition product of menadione and sodium bisulfite containing not less than 30 percent of menadione. Status Under Food Additive Amendments: Poultry two (2) to four (4) grams per ton.
(21) Menhaden oil. Article or Substance Indicated: The oil extracted from whole menhaden.
(22) Niacin; nicotinic acid (21 CFR 582.5530). Article or Substance Indicated: Crystalline nicotine acid -- commercial feed grade. Status Under Food Additive Amendments: GRAS.
(23) Niacinamide; nicotinamide (21 CFR 582.5535). Article or Substance Indicated: Crystalline amide of nicotinic acid -- commercial feed grade. Status Under Food Additive Amendments: GRAS.
(24) p-Aminobenzoic acid. Article or Substance Indicated: p-Aminobenzoic acid -- commercial feed grade.
(25) Pyridoxine hydrochloride (21 CFR 582.5676). Article or Substance Indicated: Crystalline chloride of pyridoxine -- commercial feed grade. Status Under Food Additive Amendments: GRAS.
(26) Riboflavin (21 CFR 582.5695). Article or Substance Indicated: Crystalline riboflavin-commercial feed grade. Status Under Food Additive Amendments: GRAS.
(27) Salmon oil. Article or Substance Indicated: The oil extracted from cannery refuse of salmon.
(28) Salmon liver oil. Article or Substance Indicated: The oil extracted from salmon livers.
(29) Sardine oil. Article or Substance Indicated: The oil extracted from cannery refuse of the packing of sardine.
(30) Shark liver oil. Article or Substance Indicated: The oil extracted from shark liver.
(31) Thiamine hydrochloride (21 CFR 582.5875). Article or Substance Indicated: Crystalline chloride of thiamine -- commercial feed grade. Status Under Food Additive Amendments: GRAS.
(32) Thiamine mononitrate (21 CFR 582.5878). Article or Substance Indicated: Crystalline mononitrate of thiamine -- commercial feed grade. Status Under Food Additive Amendments: GRAS.
(33) Tocopherol (21 CFR 582.5890). Article or Substance Indicated: a-Tocopherol -- commercial feed grade. Status Under Food Additive Amendments: GRAS.
(34) a-Tocopherol acetate (21 CFR 582.5892). Article or Substance Indicated: Commercial feed grade dl-a-tocopheryl acetate d-a-tocopheryl acetate. Status Under Food Additive Amendments: GRAS.
(35) Tuna oil. Article or Substance Indicated: The oil extracted from cannery refuse of tuna.
(36) Vitamin A acetate (21 CFR 582.5933). Article or Substance Indicated: Vitamin A acetate -- commercial feed grade. Status Under Food Additive Amendments: GRAS.
(37) Vitamin A palmitate (21 CFR 582.5936). Article or Substance Indicated: Vitamin A palmitate -- commercial feed grade. Status Under Food Additive Amendments: GRAS.
(38) Vitamin A propionate. Article or Substance Indicated: Consists of retinol or esters of retinol formed from edible fatty acids.
(39) Wheat germ oil. Article or Substance Indicated: The oil extracted or expressed from wheat germ.
(r) Source of Vitamins and Their Levels.
(1) "Vitamin Compound" is the term to be used in ingredient statement when declaring fortification.
(2) "Vitamin" is the term to be used in guaranteed analysis statement when guaranteeing the level of the vitamin.
(3) "Vitamin/Vitamin Compound" is the ratio based on molecular weights and may not be proportional to biological activity.
(4) Vitamin Compound: L-Ascorbyl-2-polyphosphate. Vitamin: Ascorbic acid. Vitamin/Vitamin Compound: 0.800.
(5) Vitamin Compound: Menadione dimethylpyrimidinol bisulfite. Vitamin: Menadione. Vitamin/Vitamin Compound: 0.454.
(6) Vitamin Compound: Menadione sodium bisulfite complex. Vitamin: Menadione. Vitamin/Vitamin Compound: 0.330.
(7) Vitamin Compound: Riboflavin-5-phosphate. Vitamin: Riboflavin. Vitamin/Vitamin Compound: 0.730.
(8) Vitamin Compound: d-Calcium pantothenate. Vitamin: d-Pantothenic acid. Vitamin/Vitamin Compound: 0.920.
(9) Vitamin Compound: Thiamine hydrochloride. Vitamin: Thiamine. Vitamin/Vitamin Compound: 0.892.
(10) Vitamin Compound: Thiamine mononitrate. Vitamin: Thiamine. Vitamin/Vitamin Compound: 0.919.
(11) Vitamin Compound: Pyridoxine hydrochloride. Vitamin: Vitamin B6. Vitamin/Vitamin Compound: 0.823.
(12) Vitamin Compound: Choline chloride. Vitamin: Choline. Vitamin/Vitamin Compound: 0.746.
(13) Vitamin Compound: Choline bitartrate. Vitamin: Choline. Vitamin/Vitamin Compound: 0.469.
(14) Vitamin Compound: Sodium ascorbate. Vitamin: Ascorbic acid. Vitamin/Vitamin Compound: 0.889.

Cal. Code Regs. Tit. 3, § 2806

Note: Authority cited: Sections 407 and 14902, Food and Agricultural Code. Reference: Sections 14992 and 15011, Food and Agricultural Code.

1. New section filed 11-12-2024 as an emergency; operative 11/12/2024 (Register 2024, No. 46). A Certificate of Compliance must be transmitted to OAL by 5-12-2025 or emergency language will be repealed by operation of law on the following day.