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HHS/FDA RIN: 0910-AH80 Publication ID: Fall 2017 
Title: ●Permanent Listing of Color Additive Lakes 

This proposed rule would streamline and clarify the regulations for color additive lakes (insoluble pigments prepared by chemically reacting water-soluble dyes with water-insoluble substances).  This proposed rule would consolidate 40 current regulatory provisions into three provisions, and would permanently list certain color additive lakes as suitable and safe for use in foods, drugs, and cosmetics.  The proposed rule also would prescribe conditions for the preparation of these lakes, permitting the use of more than one dye in the preparation of a lake.  The proposed rule would take advantage of and support advances in innovations for the chemical analysis of lakes as part of the current FDA certification procedures, where our chemists analyze a sample of each color additive batch to ensure it meets the requirements for composition and purity stated in the regulations.  The proposed rule would further clarify product labeling requirements for these color additives, thereby removing a source of potential confusion for product manufacturers. 

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Not Yet Determined   
Legal Deadline:  None
Action Date FR Cite
NPRM  08/00/2018 
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 RM1049 HFS-106,
College Park, MD 20740
Phone:240 402-1119