Listing of Color Additives Exempt From Certification; Galdieria Extract Blue; 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-2021-C-0925]</DEPDOC> <SUBJECT>Listing of Color Additives Exempt From Certification; Galdieria Extract Blue; 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 galdieria extract blue as a color additive at levels consistent with good manufacturing practice (GMP) in: non-alcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives). </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 20104), 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> Stephanie A. Hice, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 301-348-1740 or Meridith L. Kelsch, 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 20104), we amended the color additive regulations to add § 73.167 (21 CFR 73.167) “Galdieria extract blue,” to provide for the safe use of galdieria extract blue as a color additive at levels consistent with GMP in: non-alcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives). We gave interested persons until June 11, 2025, to file objections or requests for a hearing (90 FR 20104). We received no objections or requests for a hearing on the final order. 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> <REGTEXT TITLE="21" PART="73"> 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. </REGTEXT> <SIG> <NAME>Grace R. Graham,</NAME> Deputy Commissioner for Policy, Legislation, and International Affairs. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2025-16046 Filed 8-20-25; 8:45 am]</FRDOC> </RULE>