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Japan Consulting on Loosening Notification Requirements for Small Amount of New Chemical Substances

On March 28th, Japanese Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy (METI), Trade and Information and Ministry of Environment (MOE) issued a notice to seek public opinion on amending parts of the Ministerial Ordinance on Notification of Small Amount of New Chemical Substances for Manufacture/Import. The open consultation will be concluded on April 26th, 2014.

In accordance with the Chemical Substance Control Law (CSCL), notification and evaluation will be required of new chemical substances (i.e., chemical substances that were newly manufactured or imported in or after 1973 and have not been evaluated) prior to their manufacture or import. However, new chemical substances to be manufactured or imported with a total amount less than 1 ton/year across the nation (so called “small amount”) can avail of an exemption of prior notification and evaluation, while prior confirmation with the 3 competent authorities is needed, according to Clause V, Article 3 (1).

Previously mentioned in the “Implementation Plan of the Amended CSCL (2009)” approved by a cabinet meeting on June 14th, 2013, the tonnage band (≤ 1 ton/year across the nation) and notification timeline (4 times/year) would be subject to change. Consensus has been reached on the proposal that for small amount of new chemicals which are unlikely to cause environmental pollution, the critical tonnage could be adjusted from “1 ton/year across the nation” to “1 ton/year of the same entity”. Meanwhile, the notification deadlines can be cancelled and application can be received anytime.

Based on the abovementioned agreement, draft amendments have been made to the application form for notifying new chemical substances used as intermediates or specifically for export and the required materials are simplified. If a company plans to manufacture or import such chemicals with amounts equal to or less than 1 ton/year, it is possible that it only needs to submit to 3 ministers:

  • A summary of prevention measures against environmental pollution caused by the new chemical substance;

  • A summary of its management system.

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