Listing of Color Additives Exempt From Certification; Galdieria Extract Blue; Confirmation of Effective Date

Document 2025-16046 is a Final Rule published by the Food and Drug Administration in the Federal Register on August 21, 2025, with an effective date of June 26, 2025. 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 Federal Register 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). View the original at https://www.federalregister.gov/documents/2025/08/21/2025-16046/listing-of-color-additives-exempt-from-certification-galdieria-extract-blue-confirmation-of.

No. Document 2025-16046 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.