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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): CAP 6C0205

Listing of Color Additives Subject to Certification; FD&C Yellow No. 5

Petitioner: Cosmetic, Toiletry, and Fragrance Association (CTFA)
Docket number (legacy and/or former docket number(s)): (92C-0293)
Subject additive and intended use: amending the color additive regulations and the drug labeling regulations to provide for the safe use of FD&C Yellow No. 5 and FD&C Yellow No. 5 Aluminum Lake for coloring drugs and cosmetics intended for use in the area of the eye
21 CFR* affected: 74.1705; FD&C Yellow No. 5
74.2705; FD&C Yellow No. 5
201.20; Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use
Substance(s)*, (CAS Registry® No.):
  • FD&C Yellow No. 5, (1934-21-0)
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  • FD&C Yellow No. 5 Aluminum Lake, (12225-21-7)
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    Federal Register publication history: Aug 10, 1992; 57 FR 35594; Notice of Filing
    Nov 29, 1994; 59 FR 60893; Final Rule; Effective date: Dec 30, 1994
    Dec 2, 1994; 59 FR 61929; Correction; Effective date: Dec 2, 1994
    Jan 26, 1995; 60 FR 5131; Final Rule; confirmation of effective date; Effective date: Dec 30, 1994


     

    *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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