Listing of Color Additives Exempt From Certification; Calcium Phosphate; Confirmation of Effective Date

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 73</CFR> <DEPDOC>[Docket No. FDA-2023-C-0544]</DEPDOC> <SUBJECT>Listing of Color Additives Exempt From Certification; Calcium Phosphate; Confirmation of Effective Date</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final amendment; order; confirmation of effective date. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is confirming the effective date of June 26, 2025, for the final order that appeared in the <E T="04">Federal Register</E> of May 12, 2025. The final order amends the color additive regulations to provide for the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> The effective date of June 26, 2025, for the final order published in the <E T="04">Federal Register</E> of May 12, 2025 (90 FR 20097) is confirmed. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> For access to the docket to read background documents or comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number found in brackets in the heading of this final order into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Rachel Morissette, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1278 or Barbara Little, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> In the <E T="04">Federal Register</E> of May 12, 2025 (90 FR 20097), we amended the color additive regulations to add § 73.80 (21 CFR 73.80) “Calcium phosphate,” to provide for the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. We gave interested persons until June 11, 2025, to file objections or requests for a hearing. We explained that, to file an objection, a person must, among other things, specify with particularity the provision(s) of the regulation to which they object and the grounds for the objection (90 FR 20097 at 20100). Within each objection, persons also must specifically state whether they request a hearing. We received two general comments, one that did not address calcium phosphate or color additives and one that disagreed with the order, but the comments did not meet the requirements to be considered an objection under 21 CFR 12.22(a)(2) or (3). Therefore, we find that the effective date of the final order that published in the <E T="04">Federal Register</E> of May 12, 2025, should be confirmed. <LSTSUB> <HD SOURCE="HED">List of Subjects in 21 CFR Part 73</HD> Color additives, Cosmetics, Drugs, Foods, Medical devices. </LSTSUB> Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and under authority delegated to the Commissioner of Food and Drugs, we are giving notice that no objections or requests for a hearing were filed in response to the May 12, 2025, final order. Accordingly, the amendments issued thereby became effective June 26, 2025. <SIG> <NAME>Grace R. Graham,</NAME> Deputy Commissioner for Policy, Legislation, and International Affairs. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2025-16047 Filed 8-20-25; 8:45 am]</FRDOC> </RULE>