[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Proposed Rules]
[Page 21675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08235]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2021-F-0366]


General Mills, Inc.; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (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 General Mills, Inc., 
proposing that the food additive regulations be amended to provide for 
the safe use of vitamin D3 as a nutrient supplement in 
yogurt at a level higher than is currently permitted.

DATES: The food additive petition was filed on February 3, 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: Marissa Santos, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-8160.

SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), we are giving notice that 
we have filed a food additive petition (FAP 1A4827), submitted on 
behalf of General Mills, Inc. by Exponent, 1150 Connecticut Ave. NW, 
Suite 1100, Washington, DC 20036. The petition proposes to amend the 
food additive regulations in Sec.  172.380 (21 CFR 172.380) Vitamin D3 
to provide for the safe use of vitamin D3 as a nutrient 
supplement in yogurt at a level higher than what is currently 
permitted.
    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 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: April 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08235 Filed 4-22-21; 8:45 am]
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