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U.S. Department of Health and Human Services

Final Rules: Food Additives and Color Additives
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Petition(s): FAP 3A4801

Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2

Petitioner: Dean Foods Company and WhiteWave Foods Company
Docket number (legacy and/or former docket number(s)): FDA-2013-N-0888
Subject additive and intended use: amending the food additive regulations to expand the safe uses of vitamin D2 as a nutrient supplement in edible plant-based beverages intended for use as milk alternatives and in edible plant-based yogurt alternatives and vitamin D3 as a nutrient supplement in milk at levels higher than those currently permitted.
21 CFR* affected: 172.379; Vitamin D2.
172.380; Vitamin D3.
Substance(s)*, (CAS Registry® No.):
  • Vitamin D2, (50-14-6)
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  • Vitamin D3, (67-97-0)
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    Federal Register publication history: Aug 16, 2013; 78 FR 49990; Notice of petition
    Jul 18, 2016; 81 FR 46578; Final Rule; Effective date: Jul 18, 2016

     

    *Definitions

    • 21 CFR: Title 21 of the Code of Federal Regulations.
    • Substance: The name of the substance listed in the CFR.
    • CAS Registry® No.: Chemical Abstract Service (CAS) Registry Number® for the substance.
    • Petitions (see also Questions and Answers About the Petition Process)
      • FAP: Food Additive Petition
      • CAP: Color Additive Petition
      • GRP: GRAS Affirmation Petition (replaced by GRAS Notification Program in 1998)
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