21 CFR §82.5

1. (a)It is free from all impurities (other than those named in paragraph (b) of this section or in the specifications set forth in such paragraph for such color) to the extent that such impurities can be avoided by good manufacturing practice.
2. (b)It conforms to the following specifications:
   1. (1)In the case of a straight color listed in subpart B:
      1. (i)Lead (as Pb), not more than 0.001 percent.
      2. (ii)Arsenic (as As2O3), not more than 0.00014 percent.
      3. (iii)Heavy metals (except Pb and As) (by precipitation as sulfides), not more than trace.
   2. (2)In the case of a straight color listed in subpart C or D:
      1. (i)Lead (as Pb), not more than 0.002 percent.
      2. (ii)Arsenic (as As2O3), not more than 0.0002 percent.
      3. (iii)Heavy metals (except Pb and As) (by precipitation as sulfides), not more than 0.003 percent.
   3. (3)In the case of a straight color which contains a barium salt listed in subpart C or D—soluble barium (in dilute HCl) (as BaCl2), not more than 0.05 percent.