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'No data' on health risks: Japan keeps Red No. 3 dye legal despite FDA ban
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TOKYO -- Japan's Consumer Affairs Agency (CAA) has stated there is "no data" showing health hazards from the food dye Red No. 3, which remains legal in Japan despite being banned by the U.S. Food and Drug Administration (FDA) over cancer concerns in lab rats.
The FDA revoked authorization for Red No. 3 on Jan. 15, citing studies linking the dye to cancer and petitions from environmental groups. In Japan, the additive is approved under the Food Sanitation Act and is widely used in sweets, pickled foods, and fish cakes. Internationally, it is also found in meat products, chewing gum, and pharmaceuticals.
Red No. 3, a tar-based dye derived from the compound erythrosine, had been used in the U.S. for over 100 years due to its stability under heat and other conditions.
The FDA's decision is based on the 1960 Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which enforces strict safety standards for food additives. However, the FDA clarified, "Studies in other animals or in humans did not show the same effect, and there is no evidence showing FD&C Red No. 3 causes cancer in humans."
In Japan, the CAA's research shows that adults aged 20 and over with regular diets consume very small amounts of Red No. 3 daily -- about 0.05 micrograms per kilogram of body weight. This is just 1/2,000 of the 0.1 milligrams per kilogram daily limit deemed safe by the World Health Organization (WHO) and other experts.
Considering the FDA's ban, the CAA will reportedly look into whether a review of the dye's safety is necessary.
(Japanese original by Ryo Watanabe and Nanako Hori, Lifestyle, Science & Environment News Department)
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