Japanese Food Allergy-Labeling System and Comparison with the International Experience; Detection and Thresholds

Abstract

In the Japanese allergy-labeling system, food labeling is mandated for 7 specific ingredients (egg, cow's milk, wheat, buckwheat, peanut, shrimp, and crab) and recommended for 21 food ingredients in reference to case numbers of actual illness and the degree of seriousness. To monitor the validity of the labeling system, official methods for the detection of specific ingredient proteins in processed foods were developed. The official methods consist of ELISA methods for screening, and western blot methods for egg and milk, and PCR methods for wheat, buckwheat, peanut, shrimp/prawn, and crab as confirmation tests. The official methods consist of ELISA methods for screening, and western blot methods for egg and milk, and PCR methods for wheat, buckwheat, peanut, shrimp/prawn, and crab as confirmation tests. Threshold amounts (a few mg/ kg) for labeling were set based on the approach of the analytical detections. Any foods containing protein allergens should be labeled if these contain allergens at greater than 10 ppm (mg/kg). Validation protocol criteria were established to standardize the Japanese official method. Food Safety Commission of Japan conducted a risk assessment of egg as a specific ingredient and judged that current labeling system for foods containing allergens is generally appropriate for "eggs". In the future, it is important to accumulate necessary scientific knowledge in order to carry out food health impact assessment including further refinement. The Japanese experience and knowledge of food allergy-labeling system would contribute to harmonize international labeling guidelines to protect allergic consumers globally.

Development of a Competitive Enzyme Immunoassay Technique for the Detection of Peanut Traces in Gluten-free Products

“…Although we are aware of the difficulties of developing a commercial ELISA kit with adequate sensitivity, its availability is necessary in order to unify and obtain an official method for each allergen and each matrix. As a result, it will be possible to determine a threshold or cut-off point from which companies must declare allergens, as was done in Japan [14]. This would be an indispensable tool for use by health authorities and by different companies.…”

Development of a simple and reliable LC-MS/MS method to simultaneously detect walnut and almond as specified in food allergen labelling regulations in processed foods

“…According to the official method of food allergen analysis in Japan, after conducting a screening test by ELISA, if the protein of the target raw material is detected in an amount of 10 mg/kg or more, PCR (for wheat, buckwheat, peanuts, shrimp, and crab) or western blotting (for milk and egg) should be performed ( Akiyama and Adachi, 2021 ).…”

“…However, in ELISA, immunochromatography, and western blotting using an antibody, cross-reactivity may occur with a component other than the target raw material, and a false positive result may be obtained ( Saito et al, 2019 ; Akiyama and Adachi, 2021 ), and in PCR, an adequate amount of DNA required for testing may not be extracted from some processed foods, and the sensitivity may be insufficient ( Linacero et al, 2020 ).…”

Accidental Ingestion of Allergic Food at Eating-Out and Home Meal Replacement by Children with Food Allergy

“…In Japan, rules regarding allergy labeling were established in 2001 in accordance with the Food Labeling Law [10, 11]. The labeling of seven ingredients (eggs, milk, wheat, peanuts, buckwheat, shrimp, and crab) must be labeled if the food contains more than a few parts per million (ppm).…”