SUPPLEMENTARY INFORMATION:

Under section 721(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice that we have filed a color additive petition (CAP 6C0342), submitted by Doehler GmbH, c/o Hogan Lovells Cadwalader, 555 13th Street NW, Washington DC, 20004. The petition proposes that we amend our color additive regulations in 21 CFR part 73 Listing of Color Additives Exempt from Certification to provide for the safe use of calcium sulfate at levels consistent with good manufacturing practice in: (1) coated candies; (2) dry milk; (3) whey products; (4) powdered creamers; and (5) icings and baked good fillings.

The petitioner has claimed that this action is categorically excluded under 21 CFR 25.32(k) because granting of this petition would authorize the use of a substance intended to remain in food through ingestion by consumers and is not intended to replace macronutrients in food. The petitioner has also claimed that this action is categorically excluded under 21 CFR 25.32(r) because granting of this petition would authorize the use of a substance that occurs naturally in the environment and the proposed uses do not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment. In addition, the petitioner has stated that, to their knowledge, no extraordinary circumstances exist. If FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. If FDA determines a categorical exclusion does not apply, we will request an environmental assessment and make it available for public inspection.

91 FR 60911