Two separate laws apply to notification of new chemicals in Japan, which are "Law Concerning the Examination and Regulation of Manufacture, etc., of Chemical Substances" commonly known as the "Chemical Substances Control Law" (CSCL), and Industrial Safety and Health Law (ISHL).
Notification Under Chemical Substance Control Law (CSCL)
The purpose of CSCL is to protect human health by preventing pollution by chemical substance. Ministry of Economy, Trade and Industry (METI) and Ministry of Health, Labour and Welfare (MHLW) jointly administer CSCL.
Media Services, Ltd. has been offering services of notification of CSCL for more than 20 years for customers inside and outside Japan by preparation and submission of the dossier and by communication or consultation to authorities which is often required during the notification process.
Biodegradation
The biodegradation study is conducted at first (following the METI Biodegradation guidelines). For substances not applicable for this method, alternative method will be found out in the consultation to NITE, which is subordinate organization to METI.
If the substance doesnft have good biodegradation, it must be examined further.
Bioaccumulation
The next stage is to evaluate the bioaccumulation. Under certain conditions, Pow will be accepted to substitute bioaccumulation test. If Pow can not substitute, bioaccumulation test has to be conducted.
Screening toxicity studies
Assuming the substance is not bioaccumulative the final step is to undertake the screening toxicity studies. These are the 28-day repeated dose oral toxicity, Ames test and in vitro chromosome aberration tests. These are conducted to MHLW methods.
Notification under the Industrial Safety and Health Law (ISHL)
The purpose of ISHL is to protect health of labor especially to prevent occupational cancer.
Ministry of Health, Labour and Welfare (MLHW) administer ISHL.
Mutagenicity is mainly checked as screening for carcinogenicity.
Media Services, Ltd. has been offering services of notification of ISHL for more than 20 years for customers inside and outside Japan.