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U.S. Department of Health and Human Services

Substances Added to Food (formerly EAFUS)

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Petition(s): FAP 7A4818 

Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3

Petitioner: Juice Products Association
Docket number (legacy and/or former docket number(s)): FDA-2017-F-3717
Subject additive and intended use: amending the food additive regulation for vitamin D3 to replace the current Reference Daily Intake (RDI) percentage values of calcium in 100 percent fruit juices and fruit juice drinks with absolute values and to update the reference for vitamin D3 specifications.
21 CFR* affected: 172.380Vitamin D3.
Substance(s)*, (CAS Registry® No.): Vitamin D367-97-0
Federal Register publication history: Jul 26, 201782 FR 34615Notification; petition for rulemaking
Aug 22, 201782 FR 39711Notification; petition for rulemaking; correction
Sep 20, 201883 FR 47557Final RuleSep 20, 2018


 


*Definitions

  • CAS Reg. No. (or other ID): Chemical Abstract Service (CAS) Registry Number® for the substance or a numerical code assigned by HFP to those substances that do not have a CAS Registry Number (977nnn-nn-n series).
  • Substance: The name of the ingredient as recognized by HFP.
  • Used for (Technical Effect): The physical or technical effect(s) the substance has in or on food; see 21 CFR 170.3(o) for definitions.
  • 21 CFR: Title 21 of the Code of Federal Regulations.
  • FEMA No.: The trade association, Flavor and Extract Manufacturers Association (FEMA), has established expert panels to evaluate and make independent determinations on the GRAS status of flavoring substances. The FEMA number is provided here as a reference to FEMA’s GRAS assessments.
  • JECFA: The Joint Expert Committee on Food Additives (JECFA) is an international expert scientific committee that is administered jointly by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). See JECFA Specifications for Flavourings <>

Color Additives

  • For a substance to be used as a color additive in the US, it must be authorized by a regulation in 21 CFR Part 73, 74, or 82.
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