(1) PURPOSE OF THE LAW AND SYSTEM
The objective of this law is to conduct necessary control over poisonous and deleterious substances from a hygiene point of view in order to maintain public health.

(2) OUTLINE OF THE LAW AND SYSTEM
Any person who manufactures or imports for the purpose of selling or distributing, or any person who engages in the sale of poisonous or deleterious substances shall be registered as a manufacturer, an importer or a seller (Article 3).
The Law requires that persons engaged in such businesses shall meet the prescribed standards for manufacturing or storing equipment of poisonous or deleterious substances and obey regulations on storing, indicating or transferring procedures, etc. when handling poisonous or deleterious substances (Articles 5, 11, 12, 14 and 15-2).

(3) CABINET ORDER AND MINISTERIAL ORDINANCES
Cabinet Order on the Designation of Poisonous and Deleterious Substances
Enforcement Order of the Poisonous and Deleterious Substances Control Law
Enforcement Regulations of the Poisonous and Deleterious Substances Control Law

(4) OUTLINE OF THE CONTROL
1) Items Covered
Poisonous and deleterious substances
i.Content of the Control
The Law requires that persons engaged in such businesses shall meet the prescribed standards for manufacturing or storing equipment of poisonous or deleterious substances and obey regulations on storage and transportation methods, indicating and transferring procedures, etc. when handling poisonous or deleterious substances.

ii.Registration System
Any person who manufactures or imports for the purpose of selling or distributing, or any person who engages in the sale of poisonous or deleterious substances (together termed as "Poisonous and Deleterious Substances Businesses") shall be registered respectively as a manufacturer, an importer or a seller. Licenses must be updated every five years for manufacturers and importers, and every six years for sellers.
Since a registration for importing business of poisonous or deleterious substances requires registration per each business office concerning items of poisonous or deleterious substances to be imported. Registration for importation is not required every time poisonous or deleterious substances are imported.

iii.Procedure for Application
Applications based on the Law, which must be supplied on the basis of each manufacturing site for the manufacturers and of each sales branch for the importers, is to be submitted initially to governor of the prefecture where the applicant resides, which will in turn be handed to the Health, Labor and Welfare Minister.
Applications for sellers must be submitted to governor of the prefecture (to ward mayor or mayro for cities with public health center or special district)of location of business on store by store basis.
Furthermore, since a network called a poisonous and deleterious substance dealer registration system has been created to connect the central and local governments, in addition to applications by paper, it is possible to carry out on-line processing for application and notification through FD. In addition, starting from March, 2004, electronic application through the MHLW electronic application/notification system has been introduced.

(5) REFERENCE INFORMATION
(Liaison Office for Further Information)
Safety Division, Pharmaceutical and Food Safety Bureau, Ministry of Health,Labour and Welfare
Tel: 03-5253-1111 http://www.mhlw.go.jp
- Poisonous and deleterious substances subject to designation is listed on the website, and a search engine is also available (http://www.nihs.go.jp/law/dokugeki/edokugeki.html)
- Newly listed and de-listed chemicals are listed on the notification page (in Japanese) (http://www.nihs.go.jp/mhlw/chemical/doku/tuuti.html)