[Federal Register Volume 78, Number 159 (Friday, August 16, 2013)]
[Proposed Rules]
[Page 49990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19915]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2013-N-0888]


Dean Foods Company and WhiteWave Foods Company; Filing of Food 
Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition submitted by the Dean Foods Company and 
the WhiteWave Foods Company proposing that the food additive 
regulations be amended to provide for the expanded safe uses of vitamin 
D2 and vitamin D3 as nutrient supplements in 
food.

DATES: The food additive petition was filed on June 27, 2013.

FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1071.

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 3A4801), submitted by the 
Dean Foods Company and the WhiteWave Foods Company, c/o Hogan Lovells 
US LLP, Columbia Square, 555 Thirteenth Street NW., Washington, DC 
20004. The petition proposes to amend 21 CFR 172.379 to provide for the 
safe use of vitamin D2 as a nutrient supplement in edible 
plant-based food products intended for use as alternatives to milk and 
milk products and to amend 21 CFR 172.380 to provide for the safe use 
of vitamin D3 as a nutrient supplement in milk at levels 
higher than those currently permitted.
    We have determined under 21 CFR 25.32(k) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

    Dated: August 12, 2013.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2013-19915 Filed 8-15-13; 8:45 am]
BILLING CODE 4160-01-P