Decision responds to concerns about cancer risks, with a maximum deadline of 2028 for product reformulation
The United States (Food and Drug Administration) announced this Wednesday (January 15, 2025) the revocation of authorization for the use of the dye “Red No. 3” – known in Brazil as Erythrosine – in foods and medicines. The agency’s measure responds to a 2022 petition that questioned the use of food additives and dyes linked to cancer in humans or animals.
The agency’s decision is based on studies that identified cancer in male laboratory rats exposed to high levels of erythrosine. The FDA clarified that the mechanism by which the dye causes cancer in male mice does not apply to humans.
Erythrosine, which provides a bright red color to many products, is not widely used compared to other certified colors in the country. Its use has been mainly in sweets, cakes, frozen desserts and toppings, in addition to some ingested medicines.
Manufacturers who use the dye in their foods will have until January 15, 2027 to reformulate the products. In the case of medicines, the deadline will be extended until January 18, 2028.
Products imported into the United States must comply with the new requirements established. Currently, the use of the dye is permitted in other countries, such as Brazil.
