Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 82.5: General specifications for straight colors.

No batch of a straight color listed in subpart B, C, or D shall be certified under this part unless:
(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.
(b) It conforms to the following specifications:
(1) In the case of a straight color listed in subpart B:
(i) Lead (as Pb), not more than 0.001 percent.
(ii) Arsenic (as As2O3), not more than 0.00014 percent.
(iii) Heavy metals (except Pb and As) (by precipitation as sulfides), not more than trace.
(2) In the case of a straight color listed in subpart C or D:
(i) Lead (as Pb), not more than 0.002 percent.
(ii) Arsenic (as As2O3), not more than 0.0002 percent.
(iii) Heavy metals (except Pb and As) (by precipitation as sulfides), not more than 0.003 percent.
(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.

Where this section sits in the code

Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A—GENERAL
PART 82—LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
Subpart A—General Provisions

No batch of a straight color listed in subpart B, C, or D shall be certified under this part unless:

(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.

(b) It conforms to the following specifications:

(1) In the case of a straight color listed in subpart B:

(i) Lead (as Pb), not more than 0.001 percent.

(ii) Arsenic (as As2O3), not more than 0.00014 percent.

(iii) Heavy metals (except Pb and As) (by precipitation as sulfides), not more than trace.

(2) In the case of a straight color listed in subpart C or D:

(i) Lead (as Pb), not more than 0.002 percent.

(ii) Arsenic (as As2O3), not more than 0.0002 percent.

(iii) Heavy metals (except Pb and As) (by precipitation as sulfides), not more than 0.003 percent.

(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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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