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Joint Press Release with the Ministry of Health, Labour and Welfare and the Ministry of the EnvironmentEstablishment of a new exemption as a prior procedure for the manufacture / import of new chemical substances

The Ministry of Economy, Trade and Industry (METI), the Ministry of Health, Labour and Welfare (MHLW), and the Ministry of the Environment (MOE) established a new exemption for new chemical substances under the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. by revising partially the related Ordinance of the Ministry. The new exemption will simplify the procedures for the manufacture / import of new chemical substances, and it is expected to promote business activities.

1. Background and outline

The Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Act No. 117 of 1973; hereinafter referred to as the “Act”) requires businesses that intend to manufacture / import any chemical substances that have not been found on the list of existing chemical substances (hereinafter referred to as “new chemical substances”) to submit a notification to the government in advance, and the government to evaluate the properties of the substances and determine if the substances should be controlled or not(Article 3 (1) of the Act). In addition, the businesses have to submit the necessary data of the new chemical substances including the test results so that the government can evaluate the new chemicals.

However, there are some exemptions of prior procedures that allow businesses to manufacture / import new chemical substances without submitting such a notification if they receive conformations from the ministers of MHLW, METI, and MOE (hereinafter referred to as the “ministers”).* **

Notes:
*1: the exemption for new chemical substances with a small volume (Article 3 (1)(v) of the Act) (hereinafter referred to as “ESV”)
Where the planned quantity of manufacture / import of a new chemical substance across Japan is less than or equal to one ton in one fiscal year, and where a business that intends to manufacture / import the new chemical substance has received confirmation from the ministers, the business is able to manufacture / import it without submitting a notification to the government. To receive the confirmation, the business needs to apply for it during the predetermined periods, four times per fiscal year.

**2: the exemption for new chemical substances for the use of intermediates / for the purpose of export (Article 3 (1)(iv) of the Act) (hereinafter referred to as “EIE”)
Where a business has received confirmation from the ministers that a new chemical substance does not pose a risk of causing environmental pollution in consideration of the intended method of handling the new chemical substance (meaning the case when a new chemical substance will be manufactured / imported for the use of intermediates / for the purpose of export, and in addition when necessary measures will be taken to prevent environmental pollution from the new chemical substance), the business is able to manufacture / import it without submitting a notification to the government. A business is able to apply for receiving the confirmation from the ministers as needed. However, when the business applies for, it is required to submit documents that explain the conditions of the related facilities in detail.

Concerning ESV, the Regulatory Reform Implementation Plan, which was approved by the Cabinet on June 14, 2014, states that the restrictions to make the total quantity across Japan, of manufacture/import of a new chemical less than or equal to one ton, and the frequency (four times a year) of businesses’ applications for receiving confirmation from the ministers should be revised so as to help businesses to increase the predictability of their business, and it also mentions that the issue should be concluded within FY2013.

In response, the ministries discussed the issue and decided that they will establish a new exemption under which businesses are allowed to manufacture / import new chemical substances when satisfying the following conditions and they are able to apply to receive confirmation from the ministers as needed:

  1. Where the planned quantity of manufacture / import of a new chemical substance PER BUSINESS (company) is less than or equal to one ton in one fiscal year; and
  2. Where a new chemical substance will be manufactured / imported for the use of intermediates / for the purpose of export, and in addition when necessary measures will be taken to prevent environmental pollution from said new chemical substance

For this purpose, the ministries decided to partially revise the provisions concerning the procedure for EIE which is required in the Ordinance Related to Notification, etc., Concerning the Manufacture or Import of New Chemical Substances (Ordinance of the Ministry of Health and Welfare and the Ministry of International Trade and Industry No. 1 of 1974).

2. Effects of the new exemption

The new exemption will help businesses to secure the predictability of their business, which has been unstable due to SSA, which stipulates the total quantity across Japan to be less than or equal to one ton in one fiscal year, as well as accepting businesses’ applies for receiving such confirmation as needed. It will also simplify the procedures required for businesses to submit detailed explanation documents, which are required under SIE.

When manufacturing / importing a new chemical substance for the use of intermediates / for the purpose of export less than or equal to one ton per fiscal year, it is expected that the new exemption can increase the predictability and significantly reduce the burden of procedures that have been imposed on the businesses, which will contribute to smoothly facilitating their business activities.

3. Promulgation and enforcement dates

Promulgation: June 30, 2014
Enforcement: October 1, 2014

Release Date

June 30, 2014

Division in Charge

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

Related Information

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