Document ID: FDA-2021-C-0925-0001
Agency: fda
Document Type: Proposed Rule
Title: Fermentalg; Filing of Color Additive Petition
Posted Date: 2021-09-09T04:00Z

[Federal Register Volume 86, Number 172 (Thursday, September 9, 2021)]
[Proposed Rules]
[Pages 50495-50496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19405]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2021-C-0925]

Fermentalg; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by Fermentalg, proposing that 
the color additive regulations be amended to provide for the safe use 
of blue Galdieria extract, derived from unicellular red algae 
(Galdieria sulphuraria), as a color additive in various food categories 
at levels consistent with good manufacturing practice.

DATES: The color additive petition was filed on July 27, 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: Stephanie A. Hice, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 301-348-1740.

SUPPLEMENTARY INFORMATION: Under section 721(d)(1) the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice 
that we have filed a color additive petition (CAP 1C0320), submitted by 
Fermentalg, 4 Rue Rivi[egrave]re, 33500 Libourne, France. The petition 
proposes to amend the color additive regulations in part 73 (21 CFR 
73), ``Listing of Color Additives Exempt from Certification,'' to 
provide for the safe use of blue Galdieria extract as a color additive 
at levels consistent with good manufacturing practice in: (1) Beverages 
and beverage bases, non-alcoholic; (2) breakfast cereals; (3) chewing 
gum; (4) confections and frostings; (5) dairy product analogs; (6) 
frozen dairy desserts and mixes; (7) fruit and water ices; (8) 
gelatins, puddings, and fillings; (9) hard candy and cough drops; (10) 
milk products; (11) processed fruits and fruit juices; (12) processed 
vegetables and vegetable juices; and (13) soft candy.
    The petitioner has claimed that this action is categorically 
excluded under 21 CFR 25.32(r) because the substance occurs naturally 
in the environment, and the proposed action does not alter 
significantly the concentration or distribution of the substance, its 
metabolites, or degradation products in the environment. In addition, 
the petitioner has stated that, to their knowledge, no extraordinary

[[Page 50496]]

circumstances exist that would warrant at least an environmental 
assessment (see 21 CFR 25.21). 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: September 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19405 Filed 9-8-21; 8:45 am]
BILLING CODE 4164-01-P