Health & Chemicals

1. The Good Laboratory Practice (GLP) Compliance Monitoring Programme of Japan for industrial chemicals for Ecotoxicity Tests

Efforts are being made to advance the global harmonization of testing methods and other procedures for evaluating the safety of chemical substances. The OECD has established the “OECD Guidelines for the Testing of Chemicals” to standardize testing methods, and the “OECD Principles of Good Laboratory Practice” to set standards that should be followed by test facilities. Under the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (This act is known as the “Chemical Substances Control Law ; CSCL”), Japanese government has adopted testing methods conforming with the OECD Guidelines for the Testing of Chemicals and has instituted a GLP Compliance Monitoring Programme for industrial chemicals based on the OECD Principles of Good Laboratory Practice.

There are seven categories of ecotoxicity tests subject to compliance confirmation under the GLP Compliance Monitoring Programme for industrial chemicals: 

• Avian Reproduction Test (TG206)
• Freshwater Alga and Cyanobacteria, Growth Inhibition Test (TG201)
• Daphnia sp., Acute Immobilisation Test (TG202)
• Fish, Acute Toxicity Testing (TG203)
• Daphnia magna Reproduction Test (TG211)
• Fish, Early-life Stage Toxicity Test (TG210)
• Sediment-Water Chironomid Toxicity Test Using Spiked Sediment (TG218)

2. A list of GLP-related Japanese regulations for industrial chemicals

For details on regulations pertaining to the GLP Compliance Monitoring Programme for industrial chemicals, see the following documents (provisional English translations).

[A-01] Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Excerpt)[PDF 1.3MB]
[A-02] Ministerial Ordinance Specifying Items for Tests Pertaining to New Chemical Substances and Studies Pertaining to the Hazardous Properties of Priority Assessment Chemical Substances and Monitoring Chemical Substances[PDF 54KB]
[A-03] Studies Specified Separately by the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry and the Minister of the Environment Pursuant to the Provisions of Article 1, paragraph (2), Article 3, and Article 5, item (iv) of the Ministerial Order to Provide for Tests of New Chemical Substances and Items for Studies Related to Hazardous Properties of Priority Assessment Chemical Substances and Monitoring Chemical Substances[PDF 199KB]
[A-04] Notice of the Good Laboratory Practice for test facilities conducting tests of New Chemical Substances etc.[PDF 571KB]
[A-05] Handling of the Study Results for determination in the Evaluation of New Chemical Substances etc.[PDF 160KB]
[A-06] National Public Service Act[PDF 379KB]
[A-07] Administrative Procedure Act (Excerpt)[PDF 412KB]
[A-08] Administrative Complaint Review Act[PDF 599KB]
[A-09] A Comparison table of OECD GLP Principles and GLP for Industrial Chemicals in Japan[PDF 418KB]

3. Application Procedure to Receive GLP Confirmation

For information on the procedures for receiving confirmation of compliance with the GLP, refer to document A-05 above. Test facilities that wish to receive confirmation need to submit an application to the competent Director-General (in the case of ecotoxicity tests, the Director-General of the Environmental Health Department, MOE), and undergo a document review and an on-site inspection as part of the confirmation process. After the initial confirmation, test facilities need to undergo this process once every three years to renew their certificate of compliance. 

• Results of aquatic toxicity tests of chemicals conducted by Ministry of the Environment in Japan (- March 2023)[PDF 185KB]
• Results of sediment toxicity tests of chemicals conducted by Ministry of the Environment in Japan (- March 2017)[PDF 21KB]