Document ID: FDA-2021-C-0787-0001
Agency: fda
Document Type: Proposed Rule
Title: Piotrovska, PTY LTD.; Filing of Color Additive Petition
Posted Date: 2021-08-20T04:00Z

[Federal Register Volume 86, Number 159 (Friday, August 20, 2021)]
[Proposed Rules]
[Pages 46803-46804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17770]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2021-C-0787]

Piotrovska, PTY LTD.; 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 Australian Laboratory 
Services, PTY LTD., on behalf of Piotrovska, PTY LTD., proposing that 
the color additive regulations be amended to expand the permitted uses 
of synthetic iron oxide as a color additive to include use in edible 
decorative paint.

DATES: The color additive petition was filed on June 28, 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, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2710; or Jessica Larkin, 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 1C0321), submitted by 
Australian Laboratory Services, PTY LTD., on behalf of Piotrovska, PTY 
LTD., Australian Laboratory Services, PTY LTD., 2-8 South Street Unit 
10, Rydalmere, NSW, 2116, Australia. The

[[Page 46804]]

petition proposes to amend the color additive regulations at 21 CFR 
73.200, a color additive regulation in 21 CFR part 73, ``Listing of 
Color Additives Exempt From Certification'') by expanding the permitted 
uses of synthetic iron oxide as a color additive to include use in 
edible decorative paint.
    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 that 
would warrant 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: August 13, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-17770 Filed 8-19-21; 8:45 am]
BILLING CODE 4164-01-P