How are food additives regulated in Japan? Furthermore, is it possible to import foods containing food additives admitted in foreign countries?
 

In principle, to manufacture, import and/or sell food additives, except for those approved by the Minister of Health, Labour and Welfare as harmless for human health, is prohibited by the Food Sanitation Law (Law No. 233 of 1947). Furthermore, in cases where standards for ingredients and use, etc. related to food additives are established, it is prohibited to manufacture, import, sell, and/or use food additives not conforming to those standards, and it is prohibited to manufacture, import, sell, and/or use processed foods containing those said additives. All food additives contained in imported foods must be approved for use in Japan. In principle, all food additives utilized in foods should be labeled.

1. Food additives are regulated under the Food Sanitation Law. The law defines food additives as follows: "Additive means substances to be used in or on food in the process of the manufacture of food or for the purpose of the processing or preservation of food by adding, mixing, infiltrating, or other means (Article 4). In principle, to manufacture, import, and/or sell food additives or supply such additives for sale, except for those approved by the Minister of Health, Labour and Welfare as harmless for human health, is prohibited (Article 10). Medicines and processed foods containing food additives are also prohibited in the same manner.

2. The food additives admitted to be utilized in Japan at present are as follows: "Designated Food Additives" designated by the Minister of Health, Labour and Welfare based on above-mentioned provisions, and contained in Table 1 of the Enforcement Regulations (Ministerial Ordinance No. 23 of 1948); "Existing Food Additives" which had been utilized in Japan until the recent 1995 amendment of the Food Sanitation Law, and were recorded in the List of Existing Food Additives (Ministerial Notification No. 120 of 1996) as exceptional substances admitted to be utilized and sold, etc. without designation because of their long use in Japan,; "Natural Flavoring Agents", including natural substances extracted from animals and plants for the purpose of adding fragrance to processed foods; "General Foods and Drinks Additives" generally supplied for eating and drinking, and utilized as food additives.

3. The Minister of Health, Labour and Welfare may designate: standards for ingredients used in food additives supplied for sale, processed foods in which those said additives are utilized, and standards for utilization inclucing maximum amount (Article 11). It is prohibited to manufacture, sell and/or import, etc. food additives not conforming to those standards, and it is prohibited to manufacture, sell and/or import, etc. processed foods containing those said additives.

4. In cases where importation of processed foods with food additives that are not designated in Japan or that do not conform to Japanese standards is desired, a request should be made to the Minister of Health, Labour and Welfare for a designation or an amendment of the standards, together with reference materials concerning the safety and effectiveness of such food additives, in accordance with Guidelines for Designation of Food Additives and Amendment of Standards for Utilization (Notification No. 29 of 1996). The Minister may consider opinions by the Food Safety Commission and the Pharmaceutical Affairs and Food Sanitation Council, and review the feasibilityof the desired designation and amendment.

5. Furthermore, all food additives utilized in the processed food should be labeled except for such limited cased as food additives utilized in the manufacturing process do not remain in the final product.