Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Food and Drug Administration

          - 21 CFR Part 73
          - [Docket No. FDA-2021-C-0925]

# 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 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 Rivière, 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                           ( print 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