21 CFR Part 74 (5): Listing of color additives subject to certification. Synthetic organic dyes and pigments. Each batch must be submitted by the manufacturer to the FDA for certification that specifications are met. Listed permitted uses (as in Part 73) of four certified organic dyes and their lakes for eye area use: (1) FD&C Blue #1; (2) FD&C Red #40; (3) FD&C Yellow #5; and (4) D&C Green #5.
21 CFR Part 82 (6): Listing of certified provisionally listed colors. Lakes: FD&C: Aluminum or calcium salt on alumina. D&C: sodium, potassium, barium, calcium, strontium, or zirconium salt on alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate, calcium carbonate. A salt prepared from straight color (i.e., D&C Red #6) by combining the color with a basic radical.
Proposed permanent listing of color additive lakes (Ref. 7): (1) list substrate (i.e., D&C Red #27 aluminum lake on alumina); (2) extenders of insoluble straight colors will no longer be called lakes (i.e., D&C Red #30); (3) permit blends of previously certified straight colors in a lake (i.e., FD&C Blue #1 and Yellow #5 aluminum lake; (4) all lakes to be prepared from previously certified batches of straight color would necessitate process changes for D&C Reds #6, #7, and #34; and (5) abbreviations permitted for cosmetic ingredient labeling, omitting FD&C, precipitate, and substrate designation (i.e., Blue 1).
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