Japan food allergen labeling regulation--history and evaluation.

According to a national survey of food allergy cases, the food-labeling system for specific allergenic ingredients (i.e., egg, milk, wheat, buckwheat, and peanut) in Japan was mandated under law on April 1, 2002. By Japanese law, labeling of allergens is designated as mandatory or recommended based on the number of cases of actual illness and the degree of seriousness. Mandatory labeling is enforced by the ministerial ordinance, and the ministerial notification recommends that foods containing walnut and soybean be labeled with subspecific allergenic ingredients. Additional labeling of shrimp/prawn and crab has also become mandatory since 2008. To monitor the validity of the labeling system, the Japanese government announced the official methods for detection of allergens in a November 2002 ministry notification. These official methods, including two kinds of enzyme-linked immunosorbent assay kits for screening, Western blotting analyses for egg and milk, and polymerase chain reaction analyses for wheat, buckwheat, peanut, shrimp/prawn and crab as confirmation tests, have provided a means to monitor the labeling system. To standardize the official methods, the Japanese government described the validation protocol criteria in the 2006 official guidelines. The guidelines stipulate that any food containing allergen proteins at greater than 10mg/kg must be labeled under the Law. This review covers the selection of the specific allergenic ingredients by the Japanese government, the implementation of regulatory action levels and the detection methods to support them, and the assessment of the effectiveness of this approach.