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Draft Reveals New Chemical Substance Registration Rules of China – JUN, 2026

2026.06.17 17:18

Author:admin

Tags: #Compliance #Chemicals by ED01

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On June 10, 2026, the Ministry of Ecology and Environment (MEE) issued a notice to call for comment for the draft of the Measures for the Environmental Management Registration of New Chemical Substances (Draft for Comments) (hereinafter referred to as “the Draft”) until July 12, 2026. The revision is undertaken to implement the provisions of the newly adopted the Ecological and Environmental Code of China, which will take effect on August 15, 2026, and which contains a dedicated chapter on chemical substance pollution risk control setting out the legal framework for the registration system.

China’s new chemical substance registration rules were first promulgated in 2003, and most recently revised in 2020 (hereinafter referred to as “the Currently Effective Measures”), which has been in effect since January 1, 2021. The current revision aims to strengthen the source‑prevention role of the registration system, enhance the scientific assessment and control of pollution risks from new chemical substances, prevent the generation of potential new pollutants at source, and protect the ecological environment and public health.

This draft Measures consists of 47 articles in five chapters: general provisions, registration procedures and requirements, follow‑up management, legal liabilities, and supplementary provisions. Main revisions include:

-   The tonnage threshold for regular registration is lowered from 10 tons or more to 1 ton or more per year of production or import volume. Substances that were previously subject to simplified registration (between 1 and 10 tons) now require regular registration. The filing category for substances below 1 ton is abolished and replaced by simplified registration.

-   For both regular and simplified registrations, ecotoxicology test reports must include data generated using test organisms of the People's Republic of China and in accordance with applicable Chinese standards. Testing facilities must also comply with Good Laboratory Practice (GLP). Non-GLP data or data from non-indigenous organisms generated outside China may no longer be accepted.

-  The current regulation sets a five-year protection period for identity information of new chemical substances from the date of first registration. The revised draft removes this fixed term, and the duration of protection will be subject to subsequent implementing rules.

-   All holders of regular registration certificates, regardless of whether annual reporting is indicated on the certificate, are required to upload their activity records for the preceding year (including time, quantity, and uses) to the information system by 31 March each year. This obligation is changed from a certificate-specified requirement to a statutory mandatory duty.

-  The maximum fine for obtaining a registration certificate by fraudulent or improper means is raised from RMB 30,000 to RMB 100,000. The same maximum fine increase applies to testing institutions that issue false reports, and penalties are extended to directly responsible personnel, together with joint disciplinary actions for dishonesty.

The newly revised Measures is suggested to enter into force on the same date as the Ecological and Environmental Code (August 15, 2026), and it will fully replace the Currently Effective Measures.

For foreign stakeholders, the most important timeline listed in the Draft is that existing filings must be converted to regular or simplified registration by 31 December 2026, otherwise they will be treated as unregistered production or import. So it is advised to finish the on-going registration within this year to avoid the uncertainty and risk caused by provision change after the implementation of the new version. In addition, it is necessary to keep up with the changes on supportive regulations and standards based on the Draft, especially those on testing methods and information protection requirements.


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