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Cabinet Decision on the Bill for the Act of Partial Revision of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.

On March 7, 2017, the Cabinet decided to approve the Bill for the Act of Partial Revision of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. and the bill will be submitted to the 193rd ordinary session of the Diet.

1. Purpose of the bill

In recent years, chemical industries have been shifting to the production of a diverse array of functional chemical substances in small quantities. In light of this trend, Japan needs to use more appropriate measures, keeping the assumption of protecting environment from being polluted by chemical substances. To this end, the government will revise the Special Arrangements for Evaluation Requirements* under which the total production quantity of new chemical substances across Japan are controlled from the existing control measures targeting the total quantity involved in manufacturing and imports of such new substances, to new measures targeting the total quantity involved in environment emission, i.e., the total quantity of the substances emitted into the environment. Besides, Japan will take enhanced measures to appropriately monitor chemical substances which are comparatively highly-toxic among those categorized in “general chemical substances”.

*Note: In principle when businesses plan to manufacture or import new chemical substances, they are required to undergo a chemical evaluation in advance by the government. However, under the Special Arrangements for Evaluation Requirements, if the quantity of the substances planned for manufacture or import is not more than the predetermined, stipulated quantity, a part or all of the advance chemical evaluation is exempted, as long as such businesses are allowed to manufacture or import the notified quantity with a simple government approval.

2. Outline of the bill

(1) Revision of the upper limit of production quantity across Japan under the Special Arrangements

Under the Special Arrangements for the production of new chemical substances, the government is required not to issue the confirmation under the Act in the case where the total planned quantity of manufacture or import of a new chemical substance across Japan exceeds a predetermined upper limit. Concerning the upper limit of production quantity, the Act of Partial Revision is to change the controlled quantity from the total planned quantity of manufacture or import of new chemical substances, to the totalestimated environment emission quantity of based on predetermined formula, i.e., the total multiplication of the quantity that businesses plan to manufacture or import and the coefficient for emission by application.

(2) Revision of the management of highly-toxic new chemical substances

The Act of Partial Revision is to take the following measures concerning new chemical substances that fall under the category of “general chemical substances” but are determined to be comparatively highlytoxic among them through the chemical analysis.

  1. The Minister of Health, Labour and Welfare (MHLW), the Minister of Economy, Trade and Industry (METI), and the Minister of the Environment (MOE) will notify the businesses that have submitted notifications for the chemical substances of the determination;
  2. MHLW, METI and MOE will issue a public notice of said determination concerning the chemical substances;
  3. The competent minister will provide instructions, advice, etc. to businesses handling said chemical substances; and
  4. Businesses handling the chemical substances are required to make all reasonable efforts to provide information on the chemical substances to their business partners, etc.

3. Effective date

As for Item 2. (1) above, the revised Act will come into effect as of the day specified by Cabinet Order within a period not exceeding three years from the date of promulgation, whereas for Item 2. (2) above, the revised Act will come into effect as of the day specified by Cabinet Order within a period not exceeding one year from the date of promulgation.

Release date

March 7, 2017

Division in Charge

Chemical Safety Office, Chemical Management Policy Division, Manufacturing Industries Bureau

Related Information

Ministry of Economy, Trade and Industry1-3-1 Kasumigaseki, Chiyoda-ku, Tokyo 100-8901, Japan Tel: +81-(0)3-3501-1511
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