Rule2025-16046
Listing of Color Additives Exempt From Certification; Galdieria Extract Blue; Confirmation of Effective Date
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 21, 2025
Effective
June 26, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 90 Issue 160 (Thursday, August 21, 2025)</title>
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[Federal Register Volume 90, Number 160 (Thursday, August 21, 2025)]
[Rules and Regulations]
[Page 40703]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16046]
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Rules and Regulations
Federal Register
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having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
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Federal Register / Vol. 90, No. 160 / Thursday, August 21, 2025 /
Rules and Regulations
[[Page 40703]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2021-C-0925]
Listing of Color Additives Exempt From Certification; Galdieria
Extract Blue; Confirmation of Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; order; confirmation of effective date.
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SUMMARY: 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).
DATES: The effective date of June 26, 2025, for the final order
published in the Federal Register of May 12, 2025 (90 FR 20104), is
confirmed.
ADDRESSES: For access to the docket to read background documents or
comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
FOR FURTHER INFORMATION CONTACT: 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.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 12, 2025 (90
FR 20104), we amended the color additive regulations to add Sec.
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 Federal
Register of May 12, 2025, should be confirmed.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Foods, Medical devices.
0
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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16046 Filed 8-20-25; 8:45 am]
BILLING CODE 4164-01-P
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