2026-19658: Filing of Color Additive Petition From Doehler GmbH; Request To Amend the Color Additive Regulations To Provide for the Safe Use of Calcium Sulfate in Various Foods at Levels Consistent With Good Manufacturing Practice

Federal Register, Volume 91 Issue 185 (Friday, September 25, 2026) [Federal Register Volume 91, Number 185 (Friday, September 25, 2026)] [Proposed Rules] [Page 60911] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2026-19658] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 73 [Docket No. FDA-2026-C-10597] Filing of Color Additive Petition From Doehler GmbH; Request To Amend the Color Additive Regulations To Provide for the Safe Use of Calcium Sulfate in Various Foods at Levels Consistent With Good Manufacturing Practice

Agency

Food and Drug Administration, HHS.

Action

Notification of petition. -----------------------------------------------------------------------

Summary

The Food and Drug Administration (FDA or we) is announcing that we have filed a color additive petition, submitted by Doehler GmbH, c/o Hogan Lovells Cadwalader, proposing that we amend our color additive regulations to provide for the safe use of calcium sulfate in various foods at levels consistent with good manufacturing practice.

Dates

The color additive petition was filed on September 10, 2026.

Addresses

For access to the docket to read background documents, go to https://www.regulations.gov and insert the docket number found in brackets in the heading of this document into the ``Search'' box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For Further Information Contact

Stephen DiFranco, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2710.

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. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2026-19658 Filed 9-24-26; 8:45 am] BILLING CODE 4164-01-P