Updates on China’s Draft Chemical Registration Rules

As reported in our newsletter, Breaking News: China’s Draft Chemical Registration Rules: What Food Companies Need to Know, China’s Ministry of Ecology and Environment (“MEE”) released draft revisions [1] to the Measures for the Environmental Management Registration of New Chemical Substances for public comment. In this article, we continue our review of the key proposed changes that may have significant implications for companies involved in the manufacture and import of new chemicals in China.

Specifically, compared with the current registration framework under MEE Order No. 12 [2], the draft revisions propose several notable changes. We summarize the key proposed amendments below.

• Registrations must be filed by China-based entities

Under the current rules, an overseas exporter may act as the applicant if it appoints a local Chinese entity as the agent. The draft removes this pathway and instead requires that the applicant be a China-registered enterprise or institution engaged in the production or import of the new chemical substance.  

For imported substances, this means that only China-based importers can act as registrants. As a practical matter, where a substance is supplied to multiple importers in China, each importer may need to submit its own application and obtain a separate registration certificate.

• Changes to registration categories and volume thresholds

Under the current MEE Order No. 12, there are three types of registrations, including regular registration, simplified registration, and filing. The draft restructures the registration framework by removing the filing category and retaining only regular and simplified registration. As a result, all new chemical substances would require a type of registration that needs approval by MEE. Substances that currently rely on filing mechanisms, such as low-volume filings or polymer filings, would need to transition into the registration regime and obtain a registration certificate.

Under the draft:

• A regular registration applies to any substance manufactured or imported at 1 tonne or more per year ; and
• A simplified registration applies to any substance below 1 tonne per year.

Regular Registration Requirements

Regular registration continues to require a comprehensive dossier, including a registration application form; physicochemical, health toxicology, and ecotoxicology studies; a risk assessment report for new chemical substance contaminants and corresponding risk control measures; and, for high-hazard substances, a socio-economic analysis demonstrating the necessity of the proposed activity.

The draft, however, provides certain data exemptions. For example, where the annual production and import volume of the new chemical substance is below 10 tonnes nationwide, applicants may be exempt from submitting the contaminants risk assessment report, corresponding risk control measures, and socio-economic analysis materials.

Further, the draft maintains reduced data requirements for certain polymers. Polymers of low concern (PLC) and polymers of which no more than 2% of the monomer or starting reactants are new chemical substances may be exempt from submitting certain physicochemical, toxicological, and ecotoxicological studies, contaminants risk assessment reports, and socio-economic analysis materials, provided that supporting documentation is submitted.

Simplified Registration

The draft also significantly reshapes simplified registration. With the removal of the filing regime, simplified registration appears to become a more important pathway for lower-volume substances. At the same time, the draft proposes to streamline simplified registration by requiring only the submission of a simplified registration application form.

In addition, it appears to narrow the scope of technical review for simplified registration. Under the current rules, the review covers, among other things, the quality of test data, persistence, bioaccumulation, toxicity, and cumulative environmental risk. By contrast, the draft limits the review primarily to substance identity and the necessity of confidential business information protection.

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The amended Measures are proposed to take effect on August 15, 2026, the same date when the new Ecological and Environmental Codes become effective. MEE will publish the technical guidelines in the future that provide more details for the implementation of amended Measures.

We will continue to monitor the draft Measures and their potential impact on the industry. In the meantime, if you have any questions or comments concerning the draft or compliance with the Chinese chemical regulations in general, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Chen Hu (hu@khlaw.com), or your existing contact at Keller and Heckman LLP.

[1] https://www.mee.gov.cn/xxgk2018/xxgk/xxgk06/202606/t20260611_1159143.html  

[2] https://www.mee.gov.cn/xxgk2018/xxgk/xxgk02/202005/t20200507_777913.html