FDA Bans Erythrosine in Food Products Following Cancer Concerns

Recently, the FDA announced the official revocation of the use of erythrosine (FD&C Red No. 3) in food and ingestible drugs. This ban, which began with cosmetics, has gradually expanded to food and pharmaceuticals over several years. The key question is why the U.S. has made this decision, what characteristics erythrosine possesses, its role in food, and how other countries regulate its use.

Erythrosine (Erythrosine, INS: 127), also known as Red No. 3, is a synthetic food coloring that imparts a vibrant cherry red color in acidic to neutral environments. It has been widely used in processed foods that require long-lasting color.

The U.S. ban is primarily based on the Delaney Clause in the Federal Food, Drug, and Cosmetic Act, which states that if a food additive is proven to cause cancer in humans or animals, the FDA cannot approve its use. Recent studies indicate a link between high levels of erythrosine and cancer in lab rats, although no such correlation has been established in humans. This finding legally renders erythrosine "unsafe," prompting a mandate for reformulation of products containing it by January 15, 2027.

In contrast, China allows erythrosine under GB2760-2024 standards, permitting its use in various food categories with maximum levels ranging from 0.015g/kg to 0.1g/kg.

Internationally, the Codex Alimentarius Commission (CAC) permits erythrosine in certain food categories, such as glacé cherries, with strict usage limits of 30mg/kg to 200mg/kg. The EU also restricts its use in canned or bottled fruits and vegetables, allowing it only for cocktail cherries and with a maximum concentration of 200mg/kg. In Australia and New Zealand, erythrosine can be used in sugar coatings and glacé cherries with specified maximum levels.

As a conclusion, companies are advised to stay updated on compliance requirements in target markets, consider the potential impact of the U.S. ban, and evaluate the feasibility of natural color alternatives or synthetic substit