Japan Proposes Amendments Regarding Online Procedures for Class I Specified Chemical Substances

Japan’s Ministry of Economy, Trade and Industry (METI) has proposed significant amendments to the procedures related to the manufacture of Class I Specified Chemical Substances under the Enforcement Regulations of the Law Concerning the Examination and Regulation of Manufacture, etc. of Chemical Substances. The proposed changes which aims to facilitate the transition to an electronic application system, were announced in a consultation notice on 25 May 2024. The public consultation period is set to conclude on 23 June 2024.

Class I and II Specified Chemical Substances

Under Japan's Chemical Substances Control Law (CSCL), Class I Specified Chemical Substances are those that have been assessed as being persistent, highly bioaccumulative, or posing a risk of long-term toxicity to human health and the environment. Manufacturers and importers of these substances must obtain a permit prior to manufacture and import. Class II Specified Chemical Substances are characterized by a risk to human health and/or the environment due to long-term toxicity, with a substantial amount remaining in the environment over large areas.

Details of the Proposed Changes

METI has clarified the conditions under which 'minor changes' notifications are required. Licensed manufacturers of Class I Specified Chemical Substances will be exempt from notifying METI if changes to manufacturing equipment do not pose a risk of leakage and do not change manufacturing capacity.

Additionally, METI's proposed amendments include the adoption of the existing annual reporting format for e-submissions, which includes monthly manufacturing, inventory, use, and storage volumes.

The transition to an online application system will require the use of electronic signatures for applications and notifications, including those related to Class II Specified Chemical Substances and the products in which they are used.

The proposed amendments are set to come into force upon promulgation, which is expected in July.