CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 1]

[CITE: 21CFR82.5]

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

Sec. 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.