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)
• Federal Register publication history: Nov 19, 1992 57 FR 54598 Notice ; Sep 3, 1999 64 FR 48288 Final rule Oct 5, 1999 ; Nov 17, 1999 64 FR 62582 Final rule; confirmation of 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)