In view of the pronouncement of the Food and Drug Administration (FDA) of the United States on the food coloring erythrosine, the General Directorate of Environmental Health and Food Safety (DIGESA in Spanish) specified that the studies received by the FDA on this ingredient also known as red 3, causes cancer in male laboratory rats exposed to high levels; but that there is no evidence to show that it causes cancer in humans.
In this context, the FDA has given manufacturers that use this colorant in food until January 15, 2027, to reformulate their products.
In a statement, DIGESA revealed that in Peru no foods with red colorant 3 have been registered that exceed the maximum limits established by the FDA and the international Codex Alimentarius.
However, in view of the FDA’s preventive pronouncement and future evidence, DIGESA requests the food industry to start the gradual replacement of the red coloring by other natural additives, as appropriate, with a deadline until January 15, 2027.
The Ministry of Health has ordered the National Institute of Health -INS/CENAN, to carry out an exhaustive review of the national and international scientific evidence and to analyze if there is additional evidence to date on this additive and its effects on health.

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.