The objective of this law is to contribute to the stability of agricultural production, the protection of popular health, and the maintenance of national life environment by establishing a system of registration for agricultural chemicals regulating their sale and use so as to ensure that they are of proper quality and are correctly and safely used.
(2) OUTLINE OF THE LAW AND SYSTEM
A manufacturer or an importer is prohibited from manufacturing and/or processing, or importing any agricultural chemical, without registering with the Minister of Agriculture, Forestry and Fishery. (Paragraph 1 of Article 2).
Any person wishing to manufacture or process agricultural chemicals overseas for export to Japan may register the said agricultural chemicals to the Minister of Agriculture, Forestry and Fisheries (Paragraph 1 of Article 15-2). A foreign applicant wishing to apply for registration shall appoint a domestic custodian (residing in Japan, including the representative of a Japanese office of a foreign juridical person) (Paragraph 2 of Article 15).
(3) CABINET ORDER AND MINISTERIAL ORDINANCES
Enforcement Order of the Agricultural Chemicals Regulation Law
Enforcement Regulations of the Agricultural Chemicals Regulation Law
(4) OUTLINE OF THE CONTROL
1) Items Covered
Agricultural chemicals (disinfectants utilized to control germs, nematodes, ticks, insects, rats and other animals and plants or viruses damaging agricultural products, pesticides and other chemicals, growth promoters utilized to increase or control in physiological functions of agricultural products, germination inhibitors and other chemicals, and natural enemies utilized to control those)
2) Procedure for Registration
(a) Manufacturers or importers may not sell agricultural chemicals they have produced, processed or imported unless these have been registered with the Minister of Agriculture, Forestry and Fisheries.
(b) Agricultural chemicals are registered by brand. When applying for registration, in addition to an application for registration, an applicant must submit tests results on the efficacy of the agricultural chemicals, any phytotoxity, toxicity, residual properties along with a sample of the agricultural chemicals (at least 200g) in accordance with the Agricultural Chemicals Regulations Law.
(c) Applications for registration of agricultural chemicals are received by Independent Administration Institution of Agricultural Chemicals Inspection Station or Ministry of Agriculture, Forestry and Fisheries. The Agricultural Chemicals Inspection Station conducts inspections concerning applications presented, various testing results and samples of agricultural chemicals. If agricultural chemicals do not fall under requirements for registration (if there is false fact on matters entered in a written application or if the relevant agricultural chemicals are deemed to injury to humans or livestock), the Minister of Agriculture, Forestry and Fisheries shall register the relevant agricultural chemicals and issue a registration certificate together with prescribed utilizing methods after the inspections.
(d) International specifications and standards for registration and safe use of agricultural chemicals are the "International Specifications Concerning the Distribution and Use of Agricultural Chemicals" of the FAO. The Japanese Agricultural Chemicals Regulation Law is similar in content to this.
(e) In order to secure the reliability of testing results presented by applicants at the time of applying for registration of agricultural chemicals, Japan introduced the GLP (Good Laboratory Practice) system for agricultural chemicals in conformity with the OECD-GLP since 1984. Japan accepts testing results conducted in accordance with the GLP system for toxicity tests submitted when applying for registration of agricultural chemicals. Tests concerning physical chemical properties, environmental fate and Aquatic organism effects are also subject to the GLP system.
[Flowchart of Registration]
[Inspection Organization]
Independent Administrative Institution of Agricultural Chemicals Inspection Station 2-772 Suzuki-cho, Kodaira-shi, Tokyo 187 Tel: 0423-83-2151
http://www.acis.go.jp/ (English/Japanese)
(5) REFERENCE INFORMATION
(Liaison Office for Further Information)
Agricultural Chemicals Administration Office, Agricultural Materials Division Production Bureau, Ministry of Agriculture, Forestry and Fisheries
Tel: 03-3502-0124 http://www.maff.go.jp