Pełny Przewodnik w j. angielskim w formacie pdf. jest załączony pod niniejszą informacją.
Guidebook for Export to Japan (Food Articles)
Guidebook for Export to Japan (Food Articles) 2011 - 1 - Copyright (C) 2011 JETRO. All rights reserved.
I. Points to Note in Exports to and Sales in Japan
1. Relevant Laws and Institutional Regulations
(1) Regulations and Procedural Requirements for Importing to Japan The importing of health foods and dietary supplements is regulated primarily by the following two laws:
1) Food Sanitation Act;
2) Customs Act.
<Food Sanitation Act>
In compliance with Notification No. 370 of the Ministry of Health, Labour and Welfare, "Standards and Criteria for Food and Additives" issued under the Food Sanitation Act, and the standards for pesticide residues, etc. (including feed additives and drugs for animals) which are included therein, health foods and dietary supplements are subject to food sanitation, which is conducted to assess the types and details of the raw ingredients, and to test the types and contents of additives, pesticide residues, mycotoxins, and so on. Import bans may be imposed on food in the event of an additive, pesticide, or other contents which are prohibited in Japan, when their levels exceed approved limits, or when the presence of mycotoxins, etc. is above allowable levels. Accordingly, health foods and dietary supplements should be checked at the production site prior to import. If levels exceed the limits of Japanese standards, guidance should be given. Pesticide residue standards adopted a negative system until 2006, under which pesticides would not be subject to control if there was no requirement for them. Amendments to the law introduced a positive list system, however, and the distribution of products is now prohibited in principle if they contain a specific level of pesticides, etc. even if there is no established requirement.
Under the Customs Act, the importing of cargo with labeling that falsifies the origin of the contents, etc. is banned.
(2) Regulations and Procedural Requirements at the Time of Sale Regulations and restrictions relevant to the sales of health foods and dietary supplements are explained below.
<Food Sanitation Act>
Under the Food Sanitation Act, sales of products that contain harmful or toxic substances or those with poor hygiene are prohibited. Sales of health foods and dietary supplements in containers and packaging are subject to mandatory labeling under the Food Sanitation Act, and provisions concerning safety labeling such as indication of food additives, allergy information, raw ingredients and source, and genetic modification, etc. are applicable. The Food Sanitation Act allows certain foods to be labeled as Food for Specified Health Use or Food with Nutrient Function Claims, which are regarded as being in-between food and pharmaceuticals. Foods that are expected to have specified health uses are allowed to be labeled as Food for Specified Health Use and indicate such claims for specific dietary uses as "helps improve digestive regularity" and "for those concerned about blood glucose level.” In order for a product to bear the Food for Specified Health Use label, approval from the Secretary General
Health foods and dietary supplements are products of food standards that are consumed for the purpose of maintaining good health by supplementing nutrients that may often be lacking in one’s daily diet. Although they are often consumed for purposes and uses similar to those in the case of pharmaceutical products, health foods and dietary supplements are not subject to the Pharmaceutical Affairs Act. There are ambiguous areas where the definition of health foods and dietary supplements are concerned. In this chapter, however, they are defined as products of food standards that are not included in the categories of pharmaceutical products or quasi drugs, and are clearly not regarded as food. Individual raw ingredients shall be handled in the appropriate chapters herein and are not discussed here. Dietary supplements are defined as products in forms similar to those of pharmaceutical products such as tablets and capsules, whose primary purpose is to provide nutrients such as vitamins and minerals. Health foods are those foods in general that are advertised as having functions that are widely beneficial for the maintenance and improvement of health, and distributed and marketed as such. Discussions on trade trends cover homogenously-mixed prepared food products and vitamins and other nutritional supplements that are imported as health food products, as well as vitamins, etc. that are imported as food additives or ingredients that are used most commonly for the purpose of nutrition support and similar benefits.
10. Health Foods and Dietary Supplement of the Consumer Affairs Agency is required, which can be very difficult as it is necessary to conduct a human clinical study, which often costs hundreds of million yen. Given this situation, measures have been taken to promote a wider application of Food for Specified Health Use, by recognizing Qualified Food for Specified Health Use, for products that have been shown to have certain health effects though not at a level of scientific evidence as required in the review process for Food for Specified Health Use applications. For Food with Nutrient Function Claims, meanwhile, products are only required to contain certain nutritional components that meet the standards set forth by the Secretary General of the Consumer Affairs Agency; it is not necessary to file an application for permit or notification, but is permissible to produce and sell such products at one’s own discretion.
<Pharmaceutical Affairs Act>
To prevent pharmaceutical products and dietary supplements from being mixed up, it is prohibited under the Pharmaceutical Affairs Act to label or advertise dietary supplements in a manner that misleadingly promotes them as having an effect or efficacy of a pharmaceutical product.
<Product Liability Act>
The Product Liability Act stipulates liability of manufacturers, etc. for damages to consumers in association with product defects, and importers are included in the category of manufacturers, etc. While unprocessed agricultural products are exempt from the Act, heat-processed health foods and dietary supplements are included in items subject to the Product Liability Act, and care should be taken with regard to safety management of relevant contents, containers, and packaging.
<Act on Specified Commercial Transactions>
The Act on Specified Commercial Transactions stipulates the protection of interest of purchasers in the direct commercial transactions made with consumers. Sales of health foods and dietary supplements in such routes as mail-order, direct marketing, telemarketing, etc. are subject to provisions of the Act on Specified Commercial Transactions.
<Act on the Promotion of Sorted Garbage Collection and Recycling of Containers and Packaging>
Under the Act on the Promotion of Sorted Garbage Collection and Recycling of Containers and Packaging, importers, etc. that sell contents using containers and packaging that are controlled by the Act (paper containers and packaging and plastic containers and packaging, etc.) shall be liable for recycling (however, small-scale enterprises of below a certain size are excluded from among enterprises subject to the Act).
(1) Procedures for Authorization of Importing and Sales
<Food Sanitation Inspection>
Under the Food Sanitation Act, the required documents (Fig. 10-2) must be submitted when filing an application for inspection with the imported food monitoring departments of Quarantine Stations, Ministry of Health, Labour and Welfare. Inspection is conducted where it has been decided necessary to check the standards and criteria or safety issues at the initial review stage. If, as a result of the initial review and inspection, no issue has been detected under the Act, the registration certificate is returned, which the applicant shall submit, along with customs documents, upon filing an application for import with Customs. In the event that it has been ruled unfit for importing, measures such as destruction or return to the shipper are taken (Fig. 10-1).
Under the Customs Business Act, import declaration must be made by importers themselves or commissioned to those qualified as registered customs specialists (including customs brokers). To accept the entry into Japan of incoming cargo arriving from a foreign country, an import declaration must be made to the competent Customs office for the bonded area where the cargo is stored. Cargo for which customs inspection is required shall undergo required inspections first, and upon payment of customs duty, national and local consumption taxes, an import permit may be given in principle.
Pliki do pobrania
Przewodnik dla eksporterów suplementów diety i zdrowej żywności
pdf | 544.57 KB