(1) PURPOSE OF THE LAW AND SYSTEM
The objective of this law is to prevent pollution of the environment by chemical substances with persistent harmful properties by establishing a system of examination to determine, whether or not such substances have chronic toxic properties, etc., which may harm human health, animal and plant health or growth before the manufacture or import of new chemical substances; and the implementation of necessary regulations in the manufacture, import, use, etc., according to the properties of these chemical substances.

(2) OUTLINE OF THE LAW AND SYSTEM
A person intending to manufacture or import new chemical substances is obliged to notify in advance the name, etc., of the said chemical substances to the Minister of Health, Labour and Welfare, the Minister of Economy Trade and Industry and the Minister of the Environment (Article 3). The Minister of Health, Labour and Welfare, the Minister of Economy Trade and Industry and the Minister of the Environment shall examine the biodegradability and bioaccumulation and whether or not harmful to human health if taken continuously, or whether or not harmful to animal and plant health or growth and if necessary, take necessary measures (Article 4).

(3) CABINET ORDER AND MINISTERIAL ORDINANCES
Enforcement Order of the Law Concerning the Examination and Regulation of Manufacture, etc., of Chemical Substances
Cabinet Order Concerning the Transitional Measure to Implement Partial Revision of Law to Amend Law concerning the Examination and Regulation of Manufacture, etc. of Chemical Substances
Ministerial Order Concerning the Notification, etc., of Manufacture or import of New Chemical Substances
Ministerial Ordinance Specifying Items Concerning the Testing of New Chemical Substances and the Study of the Hazardous Properties of Type I Monitored Chemical Substances and Type II Monitored Chemical Substances
Ministerial Ordinance Specifying Items Concerning the Study of the Hazardous Properties of Type III Monitored Chemical Substances
Ministerial Ordinance to Notify the Hazardous Properties

(4) OUTLINE OF THE CONTROL
1) Items Covered
New chemical substances

2) Outline of Specifications, Standards and Inspections
i.Classification of Chemical Substances
(a) Class I Specified Chemical Substances
Manufacture, import and use are prohibited in principle.

(b) Class II Specified Chemical Substances
A manufactured or imported quantity (planned and actual) should be notified.
An order to change the manufacturing or importing quantity may be issued when necessary.
Technical guidelines officially announced should be observed.
Labeling is mandatory.

(c) Type II Monitoring Chemical Substance (previous Designated Chemical Substances)
Actual manufacturing or importing quantity should be reported.
An investigation of harmful effects may be ordered when necessary.

The new Law in April 2004 introduced hazard-based assessment relating an effect on plants and animals in the environment, and monitoring measures during the identification period of hazards relating persistent or chronic toxic properties.
Thus, in addition to Specified Chemical Substances, Classes I - III Monitoring Chemical Substance are designated as objects of regulation.

ii.Procedures for notification
An applicant identifies the name and intended use of chemical substances and notifies them together with the testing results of biodegradability, bioaccumulation and toxicity. Testing items and methods are based upon OECD recommendations. Procedures for application are simplified and foreign testing data are accepted if data are obtained by testing laboratories which meet standards set by the OECD (GLP: Good Laboratory Practice).

iii. Certification System

http://www.meti.go.jp/english/information/data/chemical_substances03.html

[Testing Agency]
Examinations in accordance with this law are conducted by the Ministry of Health, Labour and Welfare (Office of Chemical Safety, Evaluation and Licensing Division, Pharmaceutical and Medical Safety Bureau), the Ministry of Economy, Trade and Industry (Chemical Safety Office, Chemical Management Policy Division, Manufacturing Industries Bureau) and the Ministry of the Environment (Chemicals Evaluation Office, Policy Planning Division, Environmental Health Department, Intergrated Environmental Policy Bureau)

(5) REFERENCE INFORMATION
(Liaison Offices for Further Information)
Office of Chemical Safety,Evaluation and Licensing Division, Pharmaceutical and Medical Safety Bureau
Ministry of Health,Labour and Welfare
Tel: 03-3595-2298 http://www.mhlw.go.jp
Chemical Safety Office, Chemical Management Policy Division, Manufacturing Industries Bureau
Ministry of Economy, Trade and Industry
Tel: 03-3501-0605
Chemical Evaluation Office, Policy Planning Division,Environmental Health Department, Intergrated Environmental Policy Bureau
Ministry of the Environment
Tel:03-5521-8253