Japan CAA Requests Voluntary Inspection of Products Containing Food Red No. 3

On April 21, 2025, Japan's Consumer Affairs Agency (CAA) issued a notice requesting enterprises to conduct voluntary inspections of the use of Food Red No. 3 (Erythrosine, CAS 16423-68-0) in food products. This action follows the U.S. Food and Drug Administration's (FDA) decision to revoke its authorization for Food Red No. 3 in food, beverages, dietary supplements, and ingested drugs. In response, Japanese authorities conducted a safety assessment of the additive.

Although the Food Sanitation Standards Committee concluded that there is no immediate need to revoke approval or revise usage standards in Japan, concerns were raised in the pharmaceutical sector. Some products were found to contain amounts of Food Red No. 3 that exceed the acceptable daily intake (ADI) set by the European Food Safety Authority (EFSA) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

As a precautionary measure, the CAA extended its request to the food sector. The targeted products are those that are distributed in Japan as of April 2025, sold in tablet, capsule, powder, or beverage form (including beverage-like soft drinks), and that indicate a recommended daily intake on their label.

Food enterprises and raw material suppliers are required to:

1. Evaluate the amount of Food Red No. 3 used and the estimated daily intake per product;

2. If the estimated intake exceeds the ADI of 0.1 mg/kg body weight/day (based on an average body weight of 55.1 kg), submit a report to the CAA by May 16, 2025. Based on the results, stakeholders are then required to consider whether actions such as adjusting the amount of Food Red No. 3 used are necessary, and report their response to the CAA within one month from the initial report.

The voluntary inspection requires close coordination between enterprises and raw material suppliers to ensure the accurate assessment of Food Red No. 3 usage and compliance with additive regulations. Developers and marketers of health foods should pay particular attention to this requirement, as it may impact product labeling and formulation strategies.

Recommended Reading

• Japan's Current Stance on Red No. 3 Following US Ban and Future for Using Colorants in Japan

• Color Additive Alert: FD&C Red No. 3 No Longer Authorized in U.S.