New Chemical Substance Notification in China-How to Successfully Transition from MEP Order No.7 to MEE Order No. 12

Background

The Provisions on Environmental Administration of New Chemical Substances were first published in 2003. In 2010, the Provisions (MEP Order No.7) were revised for the first time. Then, after nine years of implementation, the second revision on the Provisions was made in 2020. The revised Provisions on the Environmental Administration of New Chemical Substances (MEE Order No. 12) were released on the 29th April, 2020 and will take effect on 1st January, 2021. The MEP Order No. 7 will be repealed simultaneously.

To ensure the continuity of new chemical substance registration work, China MEE has released Notice regarding maintaining the continuity of new chemical substance registration for public comments.

What do enterprises need to know before the implementation of MEE Order No. 12? How will enterprises be affected due to the revision of new chemical substance environmental administration regulations?

1. Annual Report for Hazardous New Substances under Priority Environmental Management 

New Substances that have completed regular notification and fall under the category of hazardous substances under priority environmental management under MEP Order No. 7: Related enterprises must submit annual reports before 30th April each year in accordance with Article 42 of the Provisions for these substances before they are supplemented into the Inventory of New Chemical Substances in China (hereinafter referred to as IECSC). 

This policy indicates that enterprises do not need to submit annual reports for substances that have simplified notification and regular notification (for hazardous new substances) under MEP Order No. 7.

China,Chemical,New Substance Notification,Registration,MEE Order No. 12,MEP Order No. 7

2. Get re-registered in case the information on the registration certificate is changed

New substances that have completed regular notification or simplified notification under MEP Order No. 7: In cases where related enterprises intend to modify the information listed in the registration certificate for these substances before they are supplemented in IECSC, holders of the registration certificates shall re-register the substances in accordance with the requirements of the Provisions.

This policy indicates that after the MEE Order No. 12 takes effect, enterprises must complete registration in accordance with the requirements of MEE Order No. 12 when they need to modify the information (including the modification of information that is not concerned with the environmental risks of the substance. These modifications include registrant’s names on the registration certificate, even if they have completed simplified notification or regular notification and have obtained the registration certificates under MEP Order No. 7. This may increase an enterprise’s workload.

China,Chemical,New Substance Notification,Registration,MEE Order No. 12,MEP Order No. 7

3. Enterprises which have failed to obtain the registration certificate before the MEE Order No. 12 effective date, must apply for registration in accordance with the requirements of MEE Order No. 12.

Enterprises which have submitted an application for new chemical substances environmental management notification under MEP Order No. 7, yet fail to obtain the registration certificate before the implementation of MEE Order No. 12 for some reason (notification materials are not qualified, the registration process cannot be completed in time, etc.), must apply for new chemical substance registration under MEE Order No. 12.

Related enterprises must pay close attention to this policy as it impacts their decision making regarding new chemical substance notification. For instance, it takes at least 4 months to go through the regular notification process. Therefore, if an enterprise requires the registration certificate before the implementation of MEE Order No. 12, they must start preparing the notification materials immediately.    

Furthermore, the Notice also gives the continuity policy on environmental risk control, information transfer, material record and retention, first activity report, new hazard characteristics information report, registration certificate cancellation, new application management, etc.

The Notice is still open for public comments before 20th June, 2020.

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Related information:

MEE Notice on maintaining the continuity of new chemical substance registration

Comparison between MEP Order No. 7 and MEE Order No. 12

New Chemical Substance Notification in China (MEP Order No. 7)