MITI/MHW

The philosophical approach of Japanese chemical control seems to be somewhat different to the rest of the developed world. For example, the fundamental aim of the MITI/MHW notification scheme [14] is to evaluate the potential human hazard from exposure to new chemicals through the environment. Therefore a stepwise testing procedure is adopted, and the ecotoxicity and toxicity studies may have to be conducted... 

The MITI/MHW [14] and MOL laws are of primary concern to non-Japanese manufacturers who export chemicals to Japan, and the former will be discussed here. 

Japanese labelling requirements are not as comprehensive as in the EC and the USA, and there is currently no legal requirement for MSDSs. Specified and designated chemical substances under the MITI/MHW scheme have to be labelled appropriately, as do dangerous substances under the MOL law and other legislation. 

For MITI/MHW notiflcation, the Japanese test methods are based on those of the OECD, although in many cases they are more stringent and the standard EC studies have to be enlarged. Many of the studies have to be reported in a prescribed format, with the data interjM eted in a specific way. There is mutual acceptance of CLP between the EC Member States and Japan. Consequently, the Japanese regulatory authorities will accept foreign studies. In principle, existing GLP-compliant studies conducted to OECD/EC methods for non-Japanese notifiers are acceptable, but the results have to be suitable for interpretation by the Japanese authorities, which in practice may mean only a positive test result is accepted. 

The physico-chemical tests required for Japanese MITI/MHW notification depend on the results of the ecotoxicological and toxicological studies, ie, in which class the substance is categorised. 

I would like to acknowledge the considerable contribution of my colleague, Ms Yasuko Otsuka, the Embassy s expert on Japanese biotechnology. I am also grateful to Dr Akihiko Mine of the Japan Bioindustry Association and representatives of MITI, MHW, MAFF, STA and Monbusho for their assistance. 

Pilot plant test for containers and packaging plastics at Kawasaki city. (PWMI) Liquefaction (6,000t/y) at Niigata city supported by MITI.(Rekisei) Liquefaction (3,000t/y) at Tachikawa city supported by MHW.fJWRF) ... 

Table 4.2 shows the responsibilities for safety in biotechnology assumed by Ministries and Agencies. Monbusho (the Ministry of Education, Science and Culture), the Science and Technology Agency (STA), the Ministry of Health and Welfare (MHW), the Ministry of International Trade and Industry (MITI) and the Ministry of Agriculture, Forestry and Fisheries... 

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