The Federal Commission for Protection against Health Risks (COFEPRIS in Spanish) is aware of the recent decision of the U.S. Food and Drug Administration (FDA) on the revocation of the authorization of the use of the colorant Red No. 3 FD&C, as well as its entry into force.
Therefore, COFEPRIS, taking into consideration the above, is currently performing the risk analysis according to the use, in compliance with Annex III Colorants with ADI (Acceptable Daily Intake) established in the Agreement by which additives and coadjuvants in food, beverages and food supplements, their use and sanitary provisions are determined, which involves a review period and will conclude in the coming weeks.
Regarding medicines, COFEPRIS has instructed its scientific advisory body, the Permanent Commission of the Pharmacopoeia of the United Mexican States, to analyze the use of Red No. 3 FD&C in the additives chapter of the FEUM, specifically in the list of colorants.