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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 2C0239

Listing of Color Additives for Coloring Bone Cement; FD&C Blue No. 2-Aluminum Lake on Alumina

Petitioner: Biomet, Inc.
Docket number (legacy and/or former docket number(s)): (92C-0348)
Subject additive and intended use: amending the color additive regulations to provide for the safe use of FD&C Blue No. 2-Aluminum Lake on alumina to color bone cement
21 CFR* affected: 74.1102; FD&C Blue No. 2
74.3102; FD&C Blue No. 2
Substance(s)*, (CAS Registry® No.):
  • FD&C Blue No. 2-Aluminum Lake, (16521-38-3)
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    Federal Register publication history: Nov 19, 1992; 57 FR 54598; Notice
    Sep 3, 1999; 64 FR 48288; Final rule; Effective date: Oct 5, 1999
    Nov 17, 1999; 64 FR 62582; Final rule; confirmation of effective date; Effective date: Oct 5, 1999


     

    *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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