21 CFR §573.304

1. (a)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. (b)The additive is added to feed as follows:
   1. (1)In complete feed for broiler chickens and growing turkeys at a level not to exceed 0.2 milligrams (mg) of chromium from chromium propionate per kilogram feed.
   2. (2)In feed for horses at a level not to exceed an intake of 4 mg of chromium from chromium propionate per horse per day.
3. (c)The additive meets the following specifications:
   1. (1)Total chromium content, 8 to 10 percent.
   2. (2)Hexavalent chromium content, less than 2 parts per million (ppm).
   3. (3)Arsenic, less than 1 ppm.
   4. (4)Cadmium, less than 1 ppm.
   5. (5)Lead, less than 0.5 ppm.
   6. (6)Mercury, less than 0.5 ppm.
   7. (7)Viscosity, not more than 2,000 centipoise.
4. (d)The additive shall be incorporated into feed as follows:
   1. (1)It shall be incorporated into each ton of 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.
   2. (2)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.
   3. (3)Chromium from all sources of supplemental chromium cannot exceed:
      1. (i)A level of 0.2 ppm in complete feed for broiler chickens and growing turkeys.
      2. (ii)An intake of 4 mg per horse per day.
5. (e)To assure safe use of the additive in addition to the other information required by the Federal Food, Drug, and Cosmetic Act:
   1. (1)The label and labeling of the additive, any feed premix, and feed shall contain the name of the additive.
   2. (2)The label and labeling of the additive and any feed premix shall also contain:
      1. (i)A guarantee for added chromium content.
      2. (ii)Adequate directions for use and cautions for use including these statements: “Caution: Follow label directions” and consistent with the directions for use, the following:
         1. (A)For feed for broiler chickens and growing turkeys, “Chromium from all sources of supplemental chromium cannot exceed 0.2 parts per million of the complete feed.”
         2. (B)For feed for horses, “Chromium from all sources of supplemental chromium cannot exceed 4 milligrams per horse per day.”