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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 1A4827

Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 in Yogurt and Other Cultured Dairy Products Fermented With Lactobacillus delbrueckii, Subspecies bulgaricus, and Streptococcus thermophilus

Petitioner: General Mills, Inc.
Docket number (legacy and/or former docket number(s)): FDA-2021-F-0366
Subject additive and intended use: amending the food additive regulations to provide for the safe use of vitamin D3 as a nutrient supplement in yogurt and other cultured dairy products fermented with Lactobacillus delbrueckii, subspecies bulgaricus (L. delbrueckii, subsp. bulgaricus), and Streptococcus thermophilus (S. thermophilus) at a level higher than is currently permitted.
21 CFR* affected: 172.380; Vitamin D3
Substance(s)*, (CAS Registry® No.):
  • Vitamin D3, (67-97-0)
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    Federal Register publication history: Feb 3, 2021; 86 FR 21675; Notification of Petition
    Sep 4, 2025; 90 FR 42699; Final amendment; order.; Effective date: Sep 4, 2025


     

    *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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