[Federal Register Volume 86, Number 123 (Wednesday, June 30, 2021)]
[Proposed Rules]
[Page 34664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13952]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2021-C-0522]


Gardenia Blue Interest Group; Filing of Color Additive Petition

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 petition, submitted by Gardenia Blue Interest 
Group (GBIG), proposing that the color additive regulations be amended 
to provide for the safe use of gardenia blue powder in various foods.

DATES: The color additive petition was filed on April 20, 2021.

ADDRESSES: For access to the docket to read background documents or 
comments received, 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 
Additive Safety (HFS-255), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240-402-2710; or Alexandra Jurewitz, Office of Regulations 
and Policy (HFS-024), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 
240-402-2378.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 721(d)(1) (21 U.S.C. 379e(d)(1))), we are giving notice 
that we have filed a color additive petition (CAP 1C0319), submitted by 
GBIG, c/o Exponent, Inc., 1150 Connecticut Avenue NW, Suite 1100, 
Washington, DC 20036. The petition proposes to amend the color additive 
regulations in part 73 (21 CFR part 73, ``Listing of Color Additives 
Exempt From Certification'') to provide for the safe use of gardenia 
blue powder as a color additive in: (1) Sport drinks; (2) flavored or 
enhanced, noncarbonated water; (3) fruit drinks and ades; (4) ready-to-
drink tea; (5) hard candy; and (6) soft candy, at levels consistent 
with good manufacturing practice.
    The petitioner has claimed that this action is categorically 
excluded under 21 CFR 25.32(k) because the substance is intended to 
remain in food through ingestion by consumers and is not intended to 
replace macronutrients in food. 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.

    Dated: June 23, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13952 Filed 6-29-21; 8:45 am]
BILLING CODE 4164-01-P


