Section 3 Research details

　Food allergy is defined as a “phenomenon where a symptom detrimental to a living organism is caused by food via antigen-specific immunological mechanism”. (food allergy examination guideline 2016 by Japanese Society of Pediatric Allergy and Clinical Immunology). Section 3 is engaged in research activities covering a wide field from administration related activities to basic research activities with the main theme of “food allergy” including development of food allergen detection method supporting the food labeling system, study on diverse sensitization route leading to food allergy occurrence, and study on impact of chemical substance against sensitization and evocation.

1. Research on allergen included in food and detection method therefor

• In Japan, labeling system for food allergen in processed food started in 2001. Today, 7 items, namely egg, milk, wheat, buckwheat, peanuts, shrimp and crab, are designated as “specific allergenic ingredient” (mandatory labeled items), and 21 items, namely almond, abalone, squid, salmon roe, orange, cashew nut, kiwifruit, beef, walnut, sesame seed, salmon, mackerel, soybean, chicken, pork, banana, matsutake mushroom, peach, yam, apple and gelatin, are designated as “subspecific allergenic ingredient” (labeling recommended items). (Food Labeling Act) Regarding the specific allergenic ingredients, detection method for food allergen is specified for labeling verification, and ELISA method is used as the screening detection method (quantitative detection method), western blotting method (egg, milk) and PCR method (wheat, buckwheat, peanut, shrimp, crab) are used as the confirmatory test method (qualitative test method). (to “Allergen” which is an attachment to notice “Guidance on Food Labeling Standards” by Consumer Affair Agency) Section 3 is engaged in the development and improvement of these test methods.) (PDF)


• In recent years, patients of various allergic diseases are increasing. In Japan, “Basic Law on the Prevention of Allergic Diseases” was announced in June of 2014, and necessity for epidemiology research, basic research and clinical research on clarification, prevention, diagnosis and treatment of allergic disease is clearly stated. (to Allergic Disease Countermeasure Basic Act) Section 3 has established a collaborative system with medical institutions, and is proceeding with identification of various allergens contained in food and with analysis of immunological mechanism related to the food allergy occurrence using biochemical and molecular biology methods.


• For food developed using biotechnologies, such as genetic modification or genome editing, it is essential to secure safety. For protein or peptide newly generated in the development process, it is essential to evaluate their allergenicity. For that purpose, Section 3 is collecting information related to known allergen and epitope, and publishing them as Allergen Database for Food Safety (ADFS). (to ADFS) In ADFS, allergenicity prediction tool based on homology as advocated by FAO/WHO and prediction tool based on comparison with the motif extracted from the allergen sequence are provided in addition to the search tool for homology with known allergen sequence and epitope sequence. Furthermore, Section 3 is undertaking research on development of high accuracy prediction tool based on a new algorithm using AI instead of simple comparison of sequences.

2. Research on diversity of food allergy and impact of chemical substance.

• Regarding food allergy, importance of sensitizing route, other than oral intake, is attracting attention. In the case of wheat allergy occurrence case by soap containing hydrolyzed wheat protein, which became a major social topic in Japan, it was considered that percutaneous/transmucosal sensitization progressed by the hydrolyzed wheat protein contained in the soap (The first case was reported in 2009. Later, total 2,111 cases were reported by 2014 through national surveillance by Japanese Society of Allergology.) Section 3 established a percutaneous sensitization animal model using mice, and studied the percutaneous sensitization in relationship with the level of hydrolysis of the wheat protein. Based on the study by Section 3 and the analytical result regarding molecular weight distribution of hydrolyzed wheat protein by the Division of Environmental Chemistry of the institute, the Japanese standards of quasi-drug ingredients were amended in 2017 to add the rule of molecular weight for the hydrolyzed wheat protein. (2017 March 30 notice by the Ministry of Health, Labour and Welfare. To information site on “quasi-pharmaceutical products material standards” of Pharmaceuticals and Medical Devices Agency) Section 3 is continuing study on sensitizing property of protein constituent in order to secure safety of quasi-pharmaceutical products and cosmetics.


• Various constituents are contained in quasi-pharmaceutical products and cosmetics. Furthermore, various substances are used in food additives or container/packaging material in the field of food as well. Regarding nanomaterial, which is widely used in recent years, while there is an expectation for its increased applications, its unexpected potential health impact due to its characteristics is also pointed out. Titanium oxide is a substance used as food additive for coloring purpose in addition to being contained in cosmetics as a sunscreen constituent, and development as a nanomaterial is also progressing. Section 3 is studying the potential impact against percutaneous sensitizing or oral intake of allergen protein when such a chemical substance, which is applied to skin and also taken orally, takes the form of a nanomaterial. By studying the potential impact of familiar chemical substance to biological function, such as the immunity system, it should lead to securement of safety and appropriate use of chemical substance.