D&C Red No. 6 and D&C Red No. 7; Change in Specification
other · Food and Drug Administration · Rule · Published 2012-07-06 · Effective 2012-08-07 · 77 FR 39921
Document
Document number
2012-16581
Federal Register citation
77 FR 39921
CFR reference
21 CFR 74
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2012-07-06
Effective date
2012-08-07
HHS docket
Docket No. FDA-2011-C-0050
Abstract
The Food and Drug Administration (FDA or the Agency) is revising its requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for "Ether-soluble matter" with a maximum limit of 0.015 percent for the recently identified impurity 1- [(4-methylphenyl)azo]-2-naphthalenol. This action is in response to a petition filed by Sun Chemical Corp.