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HHS/FDA RIN: 0910-AH80 Publication ID: Fall 2023 
Title: Permanent Listing of Color Additive Lakes 

The Food and Drug Administration (FDA) is proposing to streamline and clarify the regulations for color additive lakes (water-insoluble pigments typically prepared by chemically reacting water-soluble dyes with water-insoluble substances). This proposed rule, if finalized, would consolidate current regulatory provisions and would permanently list certain provisionally listed color additive lakes as suitable and safe for use in foods, drugs, and cosmetics. The proposed rule, if finalized, also would prescribe conditions for the preparation and labeling of these lakes.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 70    21 CFR 73    21 CFR 74    21 CFR 80 to 82    21 CFR 101    21 CFR 178    21 CFR 701   
Legal Authority: 21 U.S.C. 379e    21 U.S.C. 371    15 U.S.C. 1454    15 U.S.C. 1455    21 U.S.C. 343    ...   
Legal Deadline:  None
Action Date FR Cite
NPRM  02/00/2025 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Julie Barrows
Supervisory Research Chemist
Department of Health and Human Services
Food and Drug Administration
4300 River Road, CPK2 Room 1049 HFS-106,
College Park, MD 20740
Phone:240 402-1119