BRIEFING

 Annatto Extracts. FCC 14. On the basis of information received, the following revisions are proposed:

1. Update the monograph's Chemical Information section to replace INS number 160b with 160b(i) and 160b(ii) for bixin and norbixin forms of Annatto Extracts.

2. Add examples of extraction solutions to the Description.

3. Remove Ethylene dichloride and Trichloroethylene and Dichloromethane from the Acceptance criteria in the test for Residual Solvents in Organic Impurities.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 This proposal is targeted for publication in the First Supplement to FCC 15.

 (FI: T. Xu)

 Case ID—SUB-1432