(a) General Provisions.(1) The mineral products section includes ingredients that come from mined and processed rock and ore deposits, chemically manufactured salts, recovered natural salts, residue or remains of living organisms, and organic salts or organically bound elements as well as other similar ingredients. Minerals from animal and plant sources can be found in other sections.(b) Ammonium Chloride is the product resulting from the neutralization of hydrochloric acid with ammonia generally expressed as NH4Cl. It must contain not less than 25.6 percent nitrogen (equivalent to 160 percent crude protein). It must contain not more than 0.1 percent moisture, 0.4 percent salt (NaCl), 15 parts per million iron (Fe), three (3) parts per million arsenic (As), and 10 parts per million heavy metals reported as lead. It may be treated with not more than one (1.0) percent tricalcium phosphate to prevent caking. It shall not be made from by-product ammonia recovered from coke oven gas. It is to be used only in feeds for cattle, sheep, and goats as a source of both non-protein nitrogen and chloride at a level not to exceed one (1.0) percent ammonium chloride in the total daily ration to provide not more than 1.6 percent equivalent crude protein. Labels for feed containing ammonium chloride include premixes, concentrates, and supplements shall contain adequate directions for use and the following prominent statements: "CAUTION: Use only as directed. For ruminants (cattle, sheep, and goats) only."(c) Ammonium Sulfate is the product resulting from the neutralization of sulfuric acid with ammonia. It shall contain not less than 21 percent nitrogen (N) and not less than 24 percent sulfur (S). It shall contain not more than 75 parts per million arsenic (As) and 30 parts per million heavy metals reported as lead. This does not include ammonium sulfate made from by-product ammonia recovered from coke-oven gas. It shall be used only in ruminant feeds as a source of sulfur and nitrogen in an amount that supplies not more than two (2) percent of equivalent crude protein in the total daily ration. If a premix, concentrate, or supplement contains more than two (2) percent of equivalent crude protein from ammonium sulfate, the label shall have adequate directions for use and a prominent statement, "Caution -- This feed shall be used only in accordance with directions furnished on the label."(d) Basic Copper Chloride is the copper salt of hydrochloric acid and hydrated form of copper oxide generally expressed as Cu2(OH)3Cl and its hydrated forms. Minimum copper (Cu) must be specified.(e) Bone Ash is the ash obtained by burning bones with free access to air, and containing a minimum of 15.3 percent phosphorus (P). The label must show a guarantee for calcium (Ca) and phosphorus (P).(f) Bone Charcoal is obtained by charring bones in closed retorts. It must contain a minimum of 14 percent phosphorus (P). It must be labeled with guarantees for calcium (Ca) and phosphorus (P). (This product is sometimes referred to as "Bone Black," however, bone charcoal must be used in all labeling.)(g) Bone Charcoal, Spent, is the product resulting from the repeated charring of bone charcoal after use in clarifying sugar solutions. It must contain a minimum of 11.5 percent phosphorus (P). It must be labeled with guarantees for phosphorus (P) and calcium (Ca). (This product is sometimes referred to as "Spent Bone Black," however, spent bone charcoal must be used in all labeling.)(h) Bone Meal, Cooked, is the dried and ground sterilized product resulting from wet cooking without steam pressure of undecomposed bones. Fat, gelatin, and meat fiber may or may not be removed. When labeled as a commercial feed ingredient, it shall carry guarantees for protein, phosphorus (P), and calcium (Ca). Cooked bone meal shall be used in all labeling. Use of this ingredient, from mammalian origins, is restricted to non-ruminant feeds unless specifically exempted by 21 CFR 589.2000. Feeds containing prohibited material must bear the following label statement: "Do not feed to cattle or other ruminants."(i) Bone Meal, Steamed, is the dried and ground product sterilized by cooking undecomposed bones with steam under pressure. Grease, gelatin, and meat fiber may or may not be removed. It must be labeled with guarantees for phosphorus (P) and calcium (Ca). Steamed bone meal must be used in all labeling. Use of this ingredient, from mammalian origins, is restricted to non-ruminant feeds unless specifically exempted by 21 CFR 589.2000. Feeds containing prohibited material must bear the following label statement: "Do not feed to cattle or other ruminants."(j) Bone Phosphate is the residue of bones that have been treated first in a hydrochloric acid solution and thereafter precipitated with lime and dried. It must contain a minimum of 17 percent phosphorus (P). It must be labeled with guarantees for calcium (Ca) and phosphorus (P).(k) Calcite is an acceptable source of calcium carbonate. It must be true to name and contain not less than 33 percent calcium (Ca).(l) Calcium Carbonate (21 CFR 582.5191) is a product true to name which contains a minimum of 38 percent calcium (Ca).(m) Calcium Carbonate, Precipitated, is an acceptable source of calcium carbonate. It must be true to name and contain not less than 33 percent calcium (Ca). Precipitated calcium carbonate must be used in all labeling.(n) Calcium Carbonate, Precipitated CaCO3 Calcium Chloride is the calcium salt of hydrochloric acid generally expressed as CaCl2 and its hydrated forms. Minimum calcium (Ca) and chlorine (Cl) must be specified.(o) Calcium Gluconate is the calcium salt of gluconic acid generally expressed as Ca(C6H11O7)2 and its hydrated forms. Minimum Calcium (Ca) must be specified.(p) Calcium Hydroxide is the hydrated form of calcium oxide generally expressed as Ca(OH)2. Minimum calcium (Ca) must be specified.(q) Calcium Iodate is the calcium salt of iodic acid generally expressed as Ca(IO3)2 and the monohydrate form. Minimum calcium (Ca) and iodine (I) must be specified.(r) Calcium Iodobehenate is the calcium salt of iodobehenic acid generally expressed as Ca(C21H42ICO2)2 and its hydrated forms. Minimum calcium (Ca) and minimum iodine (I) must be specified.(s) Calcium Oxide is the oxide form of calcium generally expressed as CaO (commonly called quicklime). The product of calcining limestone. A strong alkali requiring caution in its use. Minimum calcium (Ca) must be specified.(t) Calcium Periodate (21 CFR 573.240) is an acceptable source of iodine. It is produced by reacting calcium iodate with calcium hydroxide or calcium oxide to form a substance consisting of not less than 60 percent by weight of penta calcium orthoperiodate containing 28 to 31 percent by weight of iodine. It is used or intended for use in salt for livestock as a source of iodine.(u) Calcium Sulfate is the calcium salt of sulfuric acid generally expressed as CaSO4 and its hydrated forms. Minimum calcium (Ca) and minimum sulfur (S) must be specified.(v) Seaweed-Derived Calcium is the dried ground product resulting from the harvest of skeletal remains of the marine algae species Lithothamnium corallioides and Phymatolithon calcareum. It is composed of mixtures of calcium carbonate (CaCO3) and magnesium carbonate (MgCO3) and is intended as a supplemental source of calcium and magnesium for animals. It contains not less than 32 percent calcium as calcium carbonate and 2.3 percent magnesium as magnesium carbonate. It shall not contain more than 40 parts per million fluorine, 40 parts per million iodine, five (5) parts per million lead, and five (5) parts per million arsenic.(w) Chalk, Precipitated, is an acceptable source of calcium carbonate. It must be true to name and contain not less than 33 percent calcium (Ca). Precipitated chalk must be used in all labeling.(x) Chromium Tripicolinate. Chromium tripicolinate is the product resulting from reaction of chromium chloride with picolinic acid. It is to be used as a source of supplemental chromium in swine diets, not to supply more than 200 parts per billion of chromium to the complete diet. Chromium from all sources of supplemental chromium cannot exceed this limit. Minimum chromium from chromium tripicolinate must be specified.(y) Chalk Rock is an acceptable source of calcium carbonate. It must be true to name and contain not less than 33 percent of calcium (Ca).(z) Clam Shells, Ground, is an acceptable source of calcium carbonate. It must be true to name and contain not less than 35 percent calcium (Ca). (aa) Cobalt Acetate is the cobalt salt of acetic acid generally expressed as Co(C2H3O2)2, and its hydrated forms. Minimum cobalt (Co) must be specified.(bb) Cobalt Carbonate is the cobalt salt of carbonic acid generally expressed as CoCO3 and its hydrated forms. Minimum cobalt (Co) must be specified.(cc) Cobalt Chloride is the cobalt salt of hydrochloric acid generally expressed as CoCl2, and its hydrated forms. Minimum cobalt (Co) must be specified.(dd) Cobalt Choline Citrate Complex is the product resulting from the complexing of the soluble cobalt salt with choline dihydrogen citrate. Minimum cobalt (Co) must be specified. When used as a commercial feed ingredient, it must be declared as "cobalt choline citrate."(ee) Cobalt Glucoheptonate is the cobalt salt of glucoheptonic acid generally expressed as C14H26O16Co.H2O. Minimum cobalt (Co) must be specified.(ff) Cobalt Gluconate is the cobalt salt of gluconic acid, generally expressed as Co(C6H11O7)2, and its hydrated forms. Minimum cobalt (Co) must be specified.(gg) Cobalt Oxide is the oxide form of cobalt generally expressed as CoO. Minimum cobalt (Co) must be specified.(hh) Cobalt Sulfate is the cobalt salt of sulfuric acid generally expressed as CoSO4 and its hydrated forms. Minimum cobalt (Co) must be specified.(ii) Copper Acetate Monohydrate is the copper salt of acetic acid generally expressed as Cu(C2H3O2)2*H2O and its hydrated forms. Minimum copper must be specified. (jj) Copper Carbonate is the copper salt of carbonic acid generally expressed as CuCO3. Minimum copper (Cu) must be specified.(kk) Copper Chloride is the copper salt of hydrochloric acid generally expressed as CuCl or CuCl2 and their hydrated forms. Minimum copper (Cu) must be specified.(ll) Copper Choline Citrate Complex is the product resulting from the complexing of the soluble copper salt with choline dihydrogen citrate. Minimum copper (Cu) must be specified. When used as a commercial feed ingredient, it must be declared as "copper choline citrate."(mm) Copper Citrate is the copper salt of citric acid generally expressed as C6H4Cu2O7. It is to be used as a source of copper in broiler feeds at levels not exceeding 185 parts per million of total dietary copper. Minimum copper (Cu) must be specified.(nn) Copper Gluconate is the copper salt of gluconic acid generally expressed as Cu(C6H11C7)2 and its hydrated forms. Minimum copper (Cu) must be specified.(oo) Copper Hydroxide is the hydrated form of copper oxide generally expressed as Cu(OH)2. Minimum copper (Cu) must be specified.(pp) Copper Orthophosphate is the copper salt of phosphoric acid generally expressed as Cu3(PO4)2 and its hydrated forms. Minimum copper (Cu) must be specified.(qq) Copper Oxide is the oxide form of copper generally expressed as CuO or Cu2O. Minimum copper (Cu) must be specified.(rr) Copper Sulfate is the copper salt of sulfuric acid generally expressed as CuSO4 and its hydrated forms. Minimum copper (Cu) must be specified.(ss) Cuprous Iodide is the copper salt of hydriodic acid generally expressed as CuI. Minimum copper (Cu) must be specified.(tt) Diiodosalicylic Acid is an iodine compound of salicylic acid generally expressed as C7H4I2O3. Minimum iodine (I) must be specified.(uu) Ethylenediamine Dihydroiodide is an organic compound of iodine generally expressed as C2H8N2.2HI. Minimum iodine (I) must be specified.(vv) Ferric Ammonium Citrate is an ammoniacally complexed iron salt of citric acid of indefinite composition sometimes expressed as Fe(NH4)C6H5O7 and its hydrated forms. Minimum iron (Fe) must be specified.(ww) Ferric Chloride is the iron salt of hydrochloric acid generally expressed as FeCl3 and its hydrated forms. Minimum iron (Fe) must be specified.(xx) Ferric Choline Citrate Complex is the product resulting from the complexing of the soluble iron salt with choline dihydrogen citrate. Minimum iron (Fe) must be specified. When used as a commercial feed ingredient it must be declared as "ferric choline citrate."(yy) Ferric Formate is an iron salt of formic acid generally expressed as Fe(HCO2)3.(zz) Ferric Phosphate is the iron salt of phosphoric acid generally expressed as FePO4 and its hydrated forms. Minimum iron (Fe) must be specified.(aaa) Ferric Pyrophosphate is the iron salt of pyrophosphoric acid generally expressed as Fe4(P2O7)3 and its hydrated forms. Minimum iron (Fe) must be specified.(bbb) Ferric Sulfate is the iron salt of sulfuric acid generally expressed as Fe2(SO4)3 and its hydrated forms. Minimum iron (Fe) must be specified.(ccc) Ferrous Carbonate is the iron salt of carbonic acid generally expressed as FeCO3. Minimum iron (Fe) must be specified.(ddd) Ferrous Chloride is the iron salt of hydrochloric acid generally expressed as FeCl2 and its hydrated forms. Minimum iron (Fe) must be specified.(eee) Ferrous Fumarate is an iron salt of fumaric acid generally expressed as FeC4H2O4. Minimum iron (Fe) must be specified.(fff) Ferrous Gluconate is the iron salt of gluconic acid generally expressed as Fe(C6H11O7)2 and its hydrated forms. Minimum iron (Fe) must be specified.(ggg) Ferrous Glycine Complex is the reaction product of one molecular equivalent of ferrous iron salt and two or more molecular equivalents of glycine, generally expressed as FeC4N2H8O4. Minimum iron (Fe) must be specified. When used as a commercial feed ingredient it must be declared as Ferrous Glycine.(hhh) Ferrous Sulfate is the iron salt of sulfuric acid generally expressed as FeSO4 and its hydrated forms. Minimum iron (Fe) must be specified.(iii) Gypsiferrous Shale is a natural occurring shale type rock containing native calcium sulfate (CaSO4). It must carry guarantees of calcium (Ca) and sulfur (S).(jjj) Iron Oxide is the oxide form of iron occurring both naturally and synthetically in various chemical valence compositions and colors -- sometimes expressed as Fe2O3. Minimum iron (Fe) must be specified.(kkk) Iron, Reduced, is a metallic form of iron obtained by reducing ferric oxide with hydrogen. Minimum iron (Fe) must be specified.(lll) Limestone, Ground, is an acceptable source of calcium carbonate. It must be true to name and contain not less than 33 percent calcium (Ca). Ground limestone must be used in all labeling.(mmm) Limestone, Magnesium or Dolomitic, is an acceptable source of magnesium and calcium carbonate. The terms are synonymous and designate a native mineral composed of mixtures of magnesium carbonate (MgCO3), and calcium carbonate (CaCO3). It must contain not less than 10 percent magnesium (Mg) and must be declared as an ingredient as magnesium limestone or dolomitic limestone.(nnn) Magnesium Carbonate is a magnesium salt of carbonic acid generally expressed as MgCO3*Mg(OH)2 and its hydrated forms. Minimum magnesium (Mg) must be specified.(ooo) Magnesium Chloride is the magnesium salt of hydrochloric acid generally expressed as MgCl2 and its hydrated forms. Minimum magnesium (Mg) must be specified.(ppp) Magnesium Gluconate is the magnesium salt of gluconic acid generally expressed as Mg(C6H11O7)2 and its hydrated forms. Minimum magnesium (Mg) must be specified. For use in animal feeds, excluding aquatic species.(qqq) Magnesium Hydroxide is the hydrated form of magnesium generally expressed as Mg(OH)2. Minimum magnesium (Mg) must be specified.(rrr) Magnesium Phosphate is the magnesium salt of phosphoric acid, generally expressed as MgHPO4 and its hydrated forms. Minimum magnesium (Mg) and phosphorus (P) and maximum fluorine (F) must be specified. It must contain not more than one part fluorine (F) to 100 parts phosphorus.(sss) Magnesium Oxide is the oxide of magnesium generally expressed as MgO. Minimum magnesium (Mg) must be specified.(ttt) Magnesium-Mica is a natural occurring magnesium, iron, and potassium layer silicate. It must be labeled with guarantees for magnesium (Mg), iron (Fe), and potassium (K).(uuu) Magnesium Sulfate is the magnesium salt of sulfuric acid generally expressed as MgSO4 and its hydrated forms. Minimum magnesium (Mg) must be specified.(vvv) Manganese Acetate is the manganese salt of acetic acid generally expressed as Mn(C2H3O2)2 and its hydrated forms. Minimum manganese (Mn) must be specified.(www) Manganese Carbonate is the manganese salt of carbonic acid generally expressed as MnCO3 and its hydrated forms. Minimum Manganese (Mn) must be specified.(xxx) Manganese Chloride is the manganese salt of hydrochloric acid generally expressed as MnCl2 and its hydrated forms. Minimum manganese (Mn) must be specified.(yyy) Manganese Citrate (Soluble) is the manganese salt of citric acid generally expressed as Mn3(C6H5O7)2 and its hydrated forms. Minimum manganese (Mn) must be specified.(zzz) Manganese Gluconate is the manganese salt of gluconic acid generally expressed as Mn(C6H11O7)2. Minimum manganese (Mn) must be specified. (aaaa) Manganese Orthophosphate is the manganese salt of phosphoric acid generally expressed as Mn3(PO4)2 and its hydrated forms. Minimum manganese (Mn) must be specified.(bbbb) Manganese Phosphate (dibasic) is the manganese salt of phosphoric acid generally expressed as MnHPO4 and its hydrated forms. Minimum manganese (Mn) must be specified.(cccc) Manganese Sulfate is the manganese salt of sulfuric acid generally expressed as MnSO4 and its hydrated forms. Minimum manganese (Mn) must be specified.(dddd) Manganous Oxide is an oxide form of manganese generally expressed as MnO. Minimum manganese (Mn) must be specified.(eeee) Metal Amino Acid Complex is the product resulting from complexing of a soluble metal salt (such as potassium or manganese) with an amino acid(s). Minimum metal content must be declared. When used as a commercial feed ingredient, it must be declared as a specific metal amino acid complex, i.e., potassium amino acid complex, copper amino acid complex, zinc amino acid complex, magnesium amino acid complex, iron amino acid complex, cobalt amino acid complex, calcium amino acid complex, and manganese amino acid complex.(ffff) Metal (specific amino acid) Complex is the product resulting from complexing a soluble metal salt with a specific amino acid. Minimum metal content must be declared. When used as a commercial feed ingredient, it must be declared as a specific metal, specific amino acid, i.e., copper lysine complex, zinc lysine complex, ferric methionine complex, manganese methionine complex and zinc methionine complex.(gggg) Metal Amino Acid Chelate is the product resulting from the reaction of a metal ion from a soluble metal salt with amino acids with a mole ratio of one mole of metal to one to three (preferably two) moles of amino acid to form coordinate covalent bonds. The chelating ligand(s) are a mixture of hydrolyzed amino acids with an average molecular weight of approximately 150, or are specific amino acid(s). The resulting molecular weight of the chelate must not exceed 800. The minimum metal content must be declared. When used as a commercial feed ingredient it must be declared as a specific metal amino acid chelate; i.e., Calcium Amino Acid Chelate, Cobalt Amino Acid Chelate, Copper Amino Acid Chelate, Iron Amino Acid Chelate, Magnesium Amino Acid Chelate, Manganese Amino Acid Chelate or Zinc Amino Acid Chelate.(hhhh) Metal Methionine Hydroxy Analogue Chelate is the product resulting from the reaction of a metal salt with 2-hydroxy-4-methylthiobutanoic acid (HMTBa), having a chelated molar ratio of one mole of metal to two moles of HMTBa to form coordinate covalent bonds. This ingredient is intended to be used as a source of trace minerals. The specific metal chelate must be declared as a metal methionine hydroxyl analogue chelate; i.e. copper methionine hydroxy analogue chelate, manganese methionine hydroxy analogue chelate, or zinc methionine hydroxy analogue chelate. The minimum metal content must be declared, and must be at least 15 percent for copper, 13 percent for manganese and 16 percent for zinc.(iiii) Metal Polysaccharide Complex is the product resulting from complexing of a soluble salt with a polysaccharide solution declared as an ingredient as the specific metal complex i.e., copper polysaccharide complex, zinc polysaccharide complex, iron polysaccharide complex, cobalt polysaccharide complex, magnesium polysaccharide complex and manganese polysaccharide complex.(jjjj) Zinc Propionate is the product resulting from reaction of a zinc salt with propionic acid. Zinc propionate is prepared with an excess of propionic acid, at an appropriate stoichiometric ratio. Minimum zinc content must be declared.(kkkk) Chromium Propionate (21 CFR 573.304). The food additive chromium propionate may be safely used in animal feed as a source of supplemental chromium in accordance with the following prescribed conditions:(1) The additive is manufactured by the reaction of a chromium salt with propionic acid, at an appropriate stoichiometric ratio, to produce triaqua-(mu3-oxo) hexakis (mu2-propionato-O,O') trichromium propionate with the empirical formula, [Cr3(O)(CH3CH2CO2)6(H2O)3]CH3CH2CO2.(2) It is added to feed as follows: (A) In the complete feed for broiler chickens and swine at a level not to exceed 0.2 milligrams of chromium from chromium propionate per kilogram of feed.(B) In cattle diets at a level not to exceed 0.5 milligrams of chromium from chromium propionate per kilogram of the complete feed. Chromium propionate must be premixed with dry ingredients prior to adding to high moisture ingredients or forages.(C) In feed for horses at a level not to exceed an intake of four (4) milligrams of chromium from chromium propionate per horse per day.(3) The additive meets the following specifications: (A) Total chromium content, eight (8) to 10 percent.(B) Hexavalent chromium content, less than two (2) parts per million.(C) Arsenic, less than one (1) parts per million.(D) Cadmium, less than one (1) parts per million.(E) Lead, less than 0.5 parts per million.(F) Mercury, less than 0.5 parts per million.(G) Viscosity, not more than 2,000 centipoise.(4) The additive shall be incorporated into feed as follows:(A) It shall be incorporated into each ton of complete feed by adding no less than one pound of a premix containing no more than 181.4 milligrams of added chromium from chromium propionate per pound.(B) The premix manufacturer shall follow good manufacturing practices in the production of chromium propionate premixes. Inventory, production, and distribution records must provide a complete and accurate history of product production.(C) Chromium from all sources of supplemental chromium cannot exceed: (i) A level of 0.2 parts per million of the complete feeds for broiler chickens and swine;(ii) A level of 0.5 parts per million of the complete feed for cattle; and(iii) An intake of four (4) milligrams per horse per day.(5) To assure safe use of the additive in addition to the other information required by the FD&C: (A) The label and labeling of the additive, any feed premix, and complete feed shall contain the name of the additive.(B) The label and labeling of the additive and any feed premix shall also contain: A guarantee for added chromium content. Adequate directions for use and cautions for use including these statements: "Caution: Follow label directions" and consistent with the directions for use, the following: "Chromium from all sources of supplemental chromium cannot exceed 0.2 parts per million of the complete feed for broiler chickens and swine and 0.5 parts per million of the complete feed for cattle." "Chromium from all sources of supplemental chromium cannot exceed four (4) milligrams per horse per day."(llll) Metal Proteinate is the product resulting from the chelation of a soluble salt with amino acids and/or partially hydrolyzed protein. It must be declared as an ingredient as the specific metal proteinate: i.e., Copper Proteinate, Zinc Proteinate, Magnesium Proteinate, Iron Proteinate, Cobalt Proteinate, Manganese Proteinate or Calcium Proteinate.(mmmm) Oyster Shell Flour is an acceptable source of calcium carbonate. It must be true to name and contain not less than 33 percent calcium (Ca).(nnnn) Ammonium Polyphosphate Solution is the product resulting from the neutralization of superphosphoric acid. It must contain not less than nine (9) percent nitrogen (N) and 13 percent phosphorus (P). It must contain not more than one (1) part fluorine (F) to 100 parts phosphorus (P), 75 parts per million of arsenic (As), and 30 parts per million of heavy metals reported as lead. It may be used in ruminant feeds as a source of both phosphorus and nitrogen in an amount that supplies not more than two (2) percent of equivalent crude protein in the total daily ration. It may be used in non-ruminant feeds as a source of phosphorus only. The maximum equivalent crude protein from this source shall not exceed 1.25 percent of the total daily ration. When incorporated into a feed for non-ruminants the label will carry a statement that the equivalent crude protein is nutritionally unavailable to the non-ruminant. It shall be labeled as follows: (example) BLUE BIRD HOG FINISHER, Crude Protein (Minimum) 16% (This includes not more than [X]% equivalent crude protein which is not nutritionally available to swine.). If a premix, concentrate or supplement for ruminants contains more than two (2) percent equivalent crude protein from ammonium polyphosphate or if a premix concentrate or supplement for non-ruminants contains more than 1.25 percent equivalent crude protein from ammonium polyphosphate, then the label must contain adequate directions for use, and a prominent statement: "Warning -- This feed must be used only in accordance with directions furnished on the label."(oooo) Calcium Phosphate is a calcium phosphate product either calcined, fused, precipitated or reacted. It must contain not more than one part fluorine (F) to 100 parts of phosphorus (P). The minimum percent of calcium (Ca) and phosphorus (P) and maximum percent of fluorine (F) must be stated on the label.(pppp) Diammonium Phosphate is the product resulting from neutralization of phosphoric acid, feed grade, or defluorinated wet-process phosphoric acid which contains not less than 17 percent nitrogen (N) and 20 percent phosphorus (P). It must contain not more than one (1) part fluorine (F) to 100 parts phosphorus (P), 75 parts per million of arsenic (As), and 30 parts per million of heavy metals reported as lead. This does not include diammonium phosphate made from by-product ammonia absorbed from coke-oven gas. It may be used in ruminant feeds as a source of both phosphorus and nitrogen in an amount that supplies not more than two (2) percent of equivalent crude protein in the total daily ration. It may be used in non-ruminant feeds as a source of phosphorus only. The maximum equivalent crude protein from diammonium phosphate must be guaranteed and the equivalent crude protein from this source shall not exceed 1.25 percent of the total daily ration. When incorporated into a feed for non-ruminants, the label will carry a statement that the equivalent crude protein is nutritionally unavailable to the non-ruminant. It shall be labeled as follows: (example) BLUE BIRD HOG FINISHER. Crude protein (minimum) 16% (This includes not more than [X]% equivalent crude protein which is not nutritionally available to swine.). If a premix, concentrate or supplement for ruminants contains more than two (2) percent equivalent crude protein from diammonium phosphate or if a premix concentrate or supplement for non-ruminants contains more than 1.25 percent equivalent crude protein from diammonium phosphate, then the label must contain adequate directions for use, and a prominent statement: "Warning -- This feed must be used only in accordance with directions furnished on the label."(qqqq) Dicalcium Phosphate is a calcium salt of phosphoric acid generally expressed as CaHPO4 and its hydrated forms. Minimum phosphorus (P), minimum calcium (Ca) and maximum fluorine (F) must be specified. It must not contain more than one (1) part of fluorine (F) to 100 parts phosphorus (P).(rrrr) Disodium Phosphate is a sodium salt of phosphoric acid generally expressed as Na2HPO4 and its hydrated forms. Minimum phosphorus (P), minimum sodium (Na) and maximum fluorine (F) must be specified. It must not contain more than one (1) part fluorine (F) to 100 parts phosphorus (P).(ssss) Monoammonium Phosphate (21 CFR 582.1141) is the product resulting from the neutralization of phosphoric acid, feed grade, or defluorinated wet-process phosphoric acid which contains not less than nine (9) percent nitrogen (N) and 23 percent phosphorus (P). It must contain not more than one (1) part fluorine (F) to 100 parts phosphorus (P), 75 parts per million of arsenic (As) and 30 parts per million of heavy metals reported as lead (Pb). It may be used in ruminant feeds as a source of both phosphorus and nitrogen in an amount that supplies not more than two (2) percent of equivalent crude protein in the total daily ration. It may be used in non-ruminant feeds as a source of phosphorus only. The maximum equivalent crude protein from mono-ammonium phosphate must be guaranteed and the equivalent crude protein from this source shall not exceed 1.25 percent of the total daily ration. When incorporated into a feed for non-ruminants the label will carry a statement that the equivalent crude protein is nutritionally unavailable to the non-ruminant. It shall be labeled as follows: (example) BLUE BIRD HOG FINISHER, Crude Protein (Minimum) 16% (This includes not more than [X]% equivalent crude protein which is not nutritionally available to swine.). If a premix, concentrate or supplement for ruminants contains more than three (3) percent equivalent crude protein from mono-ammonium phosphate or if a premix concentrate or supplement for non-ruminants contains more than 1.25 percent equivalent crude protein from mono-ammonium phosphate, then the label must contain adequate directions for use, and a prominent statement: "Warning -- This feed must be used only in accordance with directions furnished on the label."(tttt) Monocalcium Phosphate is a calcium salt of phosphoric acid generally expressed as CaH4(PO4)2 and its hydrated forms. Minimum phosphorus (P), minimum calcium (Ca) and maximum fluorine (F) must be specified. It must contain not more than one (1) part fluorine (F) to 100 parts phosphorus (P).(uuuu) Monosodium Phosphate is a sodium salt of phosphoric acid generally expressed as NaH2PO4 and its hydrated forms. Minimum phosphorus (P), minimum sodium (Na) and maximum fluorine (F) must be specified. It must contain not more than one (1) part fluorine (F) to 100 parts phosphorus (P). (Published 1975) IFN 6-04-288 Sodium phosphate monobasic monohydrate NaH2PO4.H2O Phosphoric Acid, [X]%, is a solution of phosphoric acid in water generally expressed as H3PO4. Minimum phosphorus (P) must be specified. It must not contain more than 100 parts per million fluorine (F) and 3.2 parts per million Arsenic (As) for each percentage of phosphorus present. When this ingredient is used as a constituent in mixed feeds, it must be indicated in the ingredient list as "phosphoric acid."(vvvv) Phosphate, Defluorinated, includes either calcined, fused, precipitated or reacted calcium phosphate. It must contain not more than one part of fluorine (F) to 100 parts of phosphorus (P). The minimum percent of calcium (Ca) and phosphorus (P) and the maximum percent of fluorine (F) must be stated on the label. The term "defluorinated" must not be used as a part of the name of any product containing more than one part of fluorine (F) to 100 parts of phosphorus (P). The term "defluorinated phosphate" must be used, where appropriate, in labeling ingredient listings.(wwww) Rock Phosphate, Soft, is the very finely divided by-product (washings) obtained from mining Florida rock phosphate by the hydraulic process. It must contain a minimum of nine (9) percent phosphorus (P) and 15 percent calcium (Ca), and not more than 30 percent clay and 1.5 percent fluorine (F). The term soft rock phosphate must be used in all labeling.(xxxx) Rock Phosphate, Ground, is ground phosphate rock. It must be labeled with guarantees for calcium (Ca) and phosphorus (P) and a maximum guarantee for fluorine (F). Ground rock phosphate must be used in all labeling.(yyyy) Rock Phosphate, Ground, Low Fluorine is ground phosphate rock that contains not more than 0.5 percent fluorine (F). Low fluorine ground rock phosphate must be used in all labeling. It must be labeled with guarantees for minimum percentages of calcium (Ca) and phosphorus (P) and for a maximum percentage of fluorine (F).(zzzz) Sodium Hexametaphosphate is the sodium salt of Phosphoric Acid generally expressed as (NaPO3)x.H2O (x=6-20) Minimum sodium and maximum fluorine must be specified. It must not contain more than one part fluorine (F) to 100 parts phosphorus (P), 75 parts per million of arsenic (As) and 30 parts per million of heavy metals reported as lead.(aaaaa) Sodium Tripolyphosphate, is a sodium salt of phosphoric acid generally expressed as Na5P3O10. Minimum sodium (Na) and maximum fluorine (F) must be specified. It must contain not more than one (1) part fluorine (F) to 100 parts phosphorus (P).(bbbbb) Tribasic Sodium Phosphate is the sodium salt of phosphoric acid generally expressed as Na3PO4 and its hydrated forms. Minimum phosphorus (P), minimum sodium (Na) and maximum fluorine (F) must be specified. It must contain not more than one (1) part fluorine (F) to 100 parts of phosphorus (P).(ccccc) Tricalcium Phosphate is a calcium salt of phosphoric acid generally expressed as Ca3(PO4)2. Minimum phosphorus (P), minimum calcium (Ca) and maximum fluorine (F) must be specified. It must contain not more than one (1) part fluorine (F) to 100 parts phosphorus (P).(ddddd) Potassium Bicarbonate is a potassium salt of carbonic acid generally expressed as KHCO3. Minimum potassium (K) must be specified.(eeeee) Potassium Carbonate is a potassium salt of carbonic acid generally expressed as K2CO3 and its hydrated forms. Minimum potassium (K) must be specified.(fffff) Potassium Citrate is a potassium salt of citric acid generally expressed as K3C6H5O7.H2O and its hydrated forms. Minimum potassium (K) must be specified.(ggggg) Potassium Chloride, is the potassium salt of hydrochloric acid generally expressed as KCl. Minimum potassium (K) must be specified.(hhhhh) Potassium Gluconate is the potassium salt of gluconic acid generally expressed as KC6H11O7 and its hydrated forms. Minimum potassium must be specified. For use in animal feeds, excluding aquatic species.(iiiii) Potassium Hydroxide (21 CFR 582.1631) is the hydroxyl form of potassium generally expressed as KOH. Minimum potassium (K) must be specified.(jjjjj) Potassium Iodate is the potassium salt of iodic acid generally expressed as KIO3. Minimum potassium (K) and minimum iodine (I) must be specified.(kkkkk) Potassium Iodide is the potassium salt of hydriodic acid generally expressed as KI. Minimum potassium (K) and iodine (I) must be specified.(lllll) Potassium Sulfate is the potassium salt of sulfuric acid generally expressed as K2SO4. Minimum potassium (K) and sulfur (S) must be specified.(mmmmm) Salt is an acceptable source of sodium chloride. It must be true to name and contain not less than 95 percent sodium chloride.(nnnnn) Iodized Salt, is a common salt (NaCl) containing not less than 0.007 percent iodine, uniformly distributed.(ooooo) Shell Flour is an acceptable source of calcium carbonate. It must be true to name and contain not less than 33 percent calcium (Ca).(ppppp) Sodium Acid Pyrophosphate is the disodium salt of pyrophosphoric acid, generally expressed as Na2HP2O7.6H2O and other hydrated forms. Minimum phosphorus; (P), minimum sodium (Na), and maximum fluorine (F), must be specified. It must contain not more than one (1) part fluorine (F) to 100 parts phosphorus (P).(qqqqq) Sodium, Pyrophosphate, Hexahydrate Sodium Bicarbonate is the sodium salt of carbonic acid generally expressed as NaHCO3. Minimum sodium (Na) must be specified.(rrrrr) Sodium Carbonate is the sodium salt of carbonic acid generally expressed as Na2CO3 and its hydrated forms. Minimum sodium (Na) must be specified.(sssss) Sodium Iodate is the sodium salt of iodic acid generally expressed as NaIO3. Minimum iodine (I) must be specified.(ttttt) Sodium Iodide is the sodium salt of hydriodic acid generally expressed as NaI. Minimum sodium (Na) and minimum iodine (I) must be specified.(uuuuu) Sodium Molybdate is the sodium salt of molybdenum, generally expressed as Na2MoO4, and its hydrated forms. Minimum molybdenum must be specified.(vvvvv) Sodium Selenate (21 CFR 573.920) is a sodium salt of selenic acid generally expressed as Na2SeO4 and its hydrated forms. Minimum selenium (Se) must be specified. All premixes shall bear adequate directions and cautions for use including this statement "Caution. Follow label directions. The addition to feed of higher levels of this premix containing selenium is not permitted."(wwwww) Sodium Selenite (21 CFR 573.920) is a sodium salt of selenious acid generally expressed as Na2SeO3 and its hydrated forms. Minimum selenium (Se) must be specified. All premixes shall bear adequate directions and cautions for use including this statement "Caution. Follow label directions. The addition to feed of higher levels of this premix containing selenium is not permitted."(xxxxx) Sodium Sesquicarbonate is the mixed sodium salt of carbonic acid, generally expressed as Na2CO3.NaHCO3.2H2O, providing not less than 90 percent of the hydrated double salt with 42 percent minimum sodium carbonate, 33 percent minimum sodium bicarbonate, and providing not less than 27.5 percent sodium.(yyyyy) Sodium Sulfate is the sodium salt of sulfuric acid generally expressed as Na2SO4 and its hydrated forms. The minimum sodium (Na) and minimum sulfur (S) must be specified.(zzzzz) Sulfur is elemental sulfur generally expressed as sulfur (S). Minimum sulfur (S) must be specified. (aaaaaa) Thymol Iodide is a mixture of iodine derivatives of thymol generally expressed as C20H24I2O2. Minimum iodine (I) must be specified.(bbbbbb) Zinc Acetate, is the zinc salt of acetic acid generally expressed as Zn(C2H3O2)2 and its hydrated forms. Minimum zinc (Zn) must be specified.(cccccc) Zinc Carbonate is the zinc salt of carbonic acid generally expressed as ZnCO3 and its hydrated forms. Minimum zinc (Zn) must be specified.(dddddd) Zinc Chloride is the zinc salt of hydrochloric acid generally expressed as ZnCl2 and its hydrated forms. Minimum zinc (Zn) must be specified. (eeeeee) Zinc Chloride Diammine Complex is the product resulting from the complexing of zinc with ammonium chloride and is generally expressed as [Zn(NH3)2] Cl2. Minimum zinc (Zn) must be specified.(ffffff) Zinc Oxide is the oxide form of zinc generally expressed as ZnO. Minimum zinc (Zn) must be specified.(gggggg) Zinc Sulfate is the zinc salt of sulfuric acid generally expressed as ZnSO4 and its hydrated forms. Minimum zinc (Zn) must be specified.(hhhhhh) Selenium Yeast (21 CFR 573.920) is a dried non-viable yeast, Saccharomyces cerevisiae, cultivated in a fed-batch fermentation that provides incremental amounts of cane molasses and selenium salts in a manner that minimizes the detrimental effects of selenium salts on the growth rate of the yeast and allows for optimal incorporation of inorganic selenium into cellular organic material. Residual inorganic selenium is eliminated in a rigorous washing process and must not exceed two (2) percent of the total selenium content in the final selenium yeast product. Guaranteed organic selenium content must be declared on the product label. The additive selenium yeast may be added to:(1) Complete feeds for chickens, turkeys, swine, beef cattle, dairy cattle, bison, sheep, goats, llamas, alpacas, and horses at a level not to exceed 0.3 part per million of selenium.(2) Feed supplements for limit feeding for beef cattle, bison, and horses at a level not to exceed an intake of three (3) milligrams per head per day.(3) Feed supplements for limit feeding for goats, llamas, and alpacas at a level not to exceed an intake of 0.7 milligrams per head per day.(4) Salt-mineral mixtures for free-choice feeding of beef cattle, bison, and horses up to 120 parts per million in a mixture for free-choice feeding at a rate not to exceed an intake of three (3) milligrams per head per day.(5) Salt-mineral mixtures for free-choice feeding for goats, llamas, and alpacas up to 90 parts per million in a mixture for free-choice feeding at a rate not to exceed an intake of 0.7 milligrams per head per day.(6) Selenium yeast shall be incorporated into each ton of complete feed by adding no less than one (1) pound of a premix containing no more than 272.4 milligrams of added selenium per pound. The label or labeling of any selenium premix shall bear adequate directions and cautions for use including this statement: "Caution: Follow label directions. The addition to feed of higher levels of this premix containing selenium is not permitted." (iiiiii) Zinc Hydroxychloride is the hydrolysis product of zinc chloride having the empirical formula Zn5(OH)8Cl2.(H2O). The particle size must not exceed 100 microns. It must contain not less than 54 percent zinc and is intended to be a source of zinc for use in livestock, poultry, and companion animal diets. It must not contain more than 20 percent chloride, 90 parts per million lead, 15 parts per million chromium, 10 parts per million arsenic, 10 parts per million cadmium, and 0.2 parts per million mercury. (jjjjjj) Manganese Hydroxychloride is the reaction product of manganese oxide and hydrochloric acid at the appropriate stoichiometric ratio, having the empirical formula Mn2(OH)3Cl. The particle size must not exceed 100 microns. It must contain not less than 44 percent manganese and is intended to be a source of manganese for use in livestock, poultry, and companion animal diets. It must not contain more than 20 percent chloride, 50 parts per million lead, 50 parts per million arsenic, 10 parts per million cadmium, and 0.5 parts per million mercury.(kkkkkk) Selenomethionine Hydroxy Analogue [R,S-2-hydroxy-4-methylselenobutanoic acid (CAS 873660-49-2)] (21 CFR 573.920) is manufactured by the reaction of elemental selenium with methyllithium to form a methylseleno salt, which is then reacted with R,S-2-hydroxybutyrolactone to form a salt of 2-hydroxy-4-methylselenobutanoic acid. After acidification and purification, the additive consists of not less than 39.5 percent total selenium by weight with a selenomethionine hydroxy analogue content of not less than 98 percent of total selenium. The total organic selenium content of the additive is not less than 99 percent of total selenium. (1) The selenomethionine hydroxy analogue meets the following specifications:(A) Arsenic, not more than two (2) parts per million;(B) Cadmium, not more than one (1) parts per million;(C) Lead, not more than one (1) parts per million; and(D) Mercury, not more than one (1) parts per million.(2) Selenium, as selenomethionine hydroxy analogue, is added to feed as follows:(A) In complete feed for chickens, turkeys, swine, beef cattle, and dairy cattle at a level not to exceed 0.3 parts per million.(B) In feed supplements for limit feeding for beef cattle at a level not to exceed an intake of three (3) milligrams per head per day.(C) In salt-mineral mixtures for free-choice feeding for beef cattle up to 120 parts per million in a mixture for free-choice feeding at a rate not to exceed an intake of three (3) milligrams per head per day.(3) To ensure safe use of the additive, in addition to the other information required by the FD&C, the label and labeling of selenomethionine hydroxy analogue in its packaged form shall contain:(A) The name, selenomethionine hydroxy analogue;(B) Minimum and maximum guarantees for a total selenium content of not less than 2.08 percent (weight/weight) and not more than 2.24 percent;(C) Minimum guarantee for selenomethionine hydroxy analogue content of not less than 5.2 percent;(D) The following statement, "Storage Conditions: Selenomethionine hydroxy analogue must be stored in a closed package at temperatures not higher than 20 degrees Celsius (68 degrees Fahrenheit)."; and(E) An expiration date not to exceed one (1) year from the date of manufacture.(4) Selenomethionine hydroxy analogue, shall be incorporated into each ton of complete feed by adding no less than one (1) pound of a premix containing no more than 272.4 milligrams of added selenium per pound.(5) The premix manufacturer shall follow good manufacturing practices in the production of selenium premixes. Inventory, production, and distribution records must provide a complete and accurate history of product production. Production controls must assure products to be what they are purported and labeled. Production controls shall include analysis sufficient to adequately monitor quality.(6) The label or labeling of any selenium premix shall bear adequate directions and cautions for use including this statement: "Caution: Follow label directions. The addition to feed of higher levels of this premix containing selenium is not permitted."(llllll) Iron-Choline Citrate Complex (21 CFR 573.580) made by reacting approximately equimolecular quantities of ferric hydroxide, choline, and citric acid may be safely used as a source of iron in animal feed. Minimum iron (Fe) must be specified. (mmmmmm) Descriptions of Salts, Complexes and Chelates.(1) Metal (Mineral) Salt. an ionic substance containing a metal cation and either an inorganic or an organic anion. The water soluble portion of a Metal (Mineral) Salt dissociates in water to give the hydrated metal cation and the free anion (or its hydrolysis product) in solution.(2) Metal (Mineral) Complex. a substance in which a metal cation (electron pair acceptor) accepts an electron pair from one or more anionic or neutral bonding partners (ligands, electron pair donors) to form chemical bonds. The water soluble portion of the complex remains as the intact complex in aqueous solution.(3) Metal (Mineral) Chelate. a metal complex (see preceding term) in which at least one ligand (electron pair donor) forms two or more bonds to the central metal ion through different atoms of the ligand. A distinctive feature of a metal chelate is the presence of a heterocyclic ring(s) in which the metal is a member of the ring. In the water soluble portion of the chelate, the heterocyclic ring(s) remains intact.Cal. Code Regs. Tit. 3, § 2790
Note: Authority cited: Sections 407 and 14902, Food and Agricultural Code. Reference: Sections 14992 and 15011, Food and Agricultural Code.
Note: Authority cited: Sections 407 and 14902, Food and Agricultural Code. Reference: Sections 14992 and 15011, Food and Agricultural Code.
1. Amendment of subsections (p) and (gg) and new subsections (hh) and (ii) filed 7-2-82; effective thirtieth day thereafter (Register 82, No. 27).
2. Editorial correction of NOTE filed 8-17-82 (Register 82, No. 34).
3. Amendment of subsection (a), including new subsection (a)(1)-(4) designators, filed 7-17-97; operative 8-16-97 (Register 97, No. 29).
4. Editorial correction of subsection (a) (Register 2002, No. 5).
5. Amendment filed 1-30-2002; operative 1-30-2002 pursuant to Government Code section 11343.4(Register 2002, No. 5).
6. Repealer and new section heading and 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.