SUPPLEMENTARY INFORMATION:

Under the Federal Food, Drug, and Cosmetic Act (section 721(d)(1) (21 U.S.C. 379e(d)(1))), we are giving notice that we have filed a color additive petition (CAP 1C0321), submitted by Australian Laboratory Services, PTY LTD., on behalf of Piotrovska, PTY LTD., Australian Laboratory Services, PTY LTD., 2-8 South Street Unit 10, Rydalmere, NSW, 2116, Australia. The ( printed page 46804) petition proposes to amend the color additive regulations at 21 CFR 73.200, a color additive regulation in 21 CFR part 73, “Listing of Color Additives Exempt From Certification”) by expanding the permitted uses of synthetic iron oxide as a color additive to include use in edible decorative paint.

The petitioner has claimed that this action is categorically excluded under 21 CFR 25.32(k) because the substance is intended to remain in food through ingestion by consumers and is not intended to replace macronutrients in food. In addition, the petitioner has stated that, to their knowledge, no extraordinary circumstances exist that would warrant an environmental assessment (see 21 CFR 25.21). 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.

86 FR 46803