China Finalizes New Chemical Substance Registration Rules

On October 24, 2026, China’s Ministry of Ecology and Environment (MEE) announced the amended Measures for the Environmental Management Registration of New Chemical Substances (“Measures”) as MEE Order 40 [1]. The amendment took effect upon publication and replaced the prior MEE Order 12 [2]. 

By way of background, MEE released a draft of the amendment in June 2026. As discussed in our previous newsletters - Breaking News: China’s Draft Chemical Registration Rules: What Food Companies Need to Know and Updates on China’s Draft Chemical Registration Rules, the draft proposed some major changes to the scope, registration categories, applicant requirements, etc. The final amendment has adopted some of those proposals but does not include the others that raised concerns for the food, cosmetic, and chemical industries.

Food and Other Product Exemptions Continue Under the Final Measures

MEE Order 40 continues to exempt pharmaceuticals, veterinary drugs, cosmetics, food, food additives, feed, feed additives, and fertilizers. Also, new chemical substances used in pesticides remain subject to the applicable pesticide regulations. The June draft did not expressly include these exemptions, creating uncertainty as to whether products regulated under other sector-specific regimes might also require new chemical substance registration.

The final text therefore addresses a key concern for companies operating in these regulated sectors. However, raw materials and intermediates of these exempted products are not exempted under MEE Order 40. This exemption does not apply either if a covered product is used in other industries. Companies should therefore continue to assess the regulatory status of upstream materials and intermediates, even where the finished products fall under these exempted product categories.

Existing Volume Thresholds Remain in Place, but Filing Is Replaced by Formal Registration

MEE Order 40 does not adopt the registration thresholds proposed in the June draft. Instead, the existing thresholds under MEE Order 12 remain in place:

• A Regular Registration applies to new substances of which the annual volume is 10 metric tonnes or more;
• A Simplified Registration applies to new substances of which the annual volume is one metric tonne or more but less than 10 metric tonnes; and
• A Formal Registration applies to new substances of which the annual volume is below one metric tonne, polymers that contain no more than 2% new monomer/reactant, and polymers of low concern (PLC).

This means that a new substance in the one-to-ten-tonne range is not moved into the Regular Registration as proposed in the draft. However, the Formal Registration is not the same as the previous Filing, which became automatically effective upon submission. The Formal Registration will be reviewed by MEE in 30 days. Any activity may not start until the registration certificate is issued upon MEE’s approval.  

It is worth noting that MEE stopped accepting new chemical substance Filings on August 15, 2026, and introduced an interim approval process for substances that previously qualified for filing [3]. The interim process is no longer valid as MEE Order 40 becomes effective.

Registrants Must Be Based in China

MEE Order 40 has adopted the draft’s restriction on registrant eligibility. Only a China-registered enterprise or institution engaged in the production or import of a new chemical substance is eligible to be a registrant of the new chemical registration.

Under MEE Order 12, an overseas manufacturer or trader could file a registration by appointing a qualified entity in China as its local agent. This option is no longer available under the amended regulation. Imported substances can only be registered by Chinese importers.

This change may affect control of registration data, confidential business information, and registration certificates. Overseas suppliers and Chinese importers may need to review their contracts, data-access arrangements, and responsibilities for maintaining the registration.

Higher Penalties Apply Under the Ecological and Environmental Code

Although the final Measures do not contain a separate chapter on penalties, violations are subject to China’s new Ecological and Environmental Code [4]. Producing or importing a new chemical substance without the required registration certificate or failing to produce or import in accordance with the certificate, may result in fines ranging from RMB 200,000 to RMB 1 million. Failure to correct the violation may result in fines of RMB 1 million to RMB 2 million and restrictions on production or suspension of production for corrective action; serious violations may lead to suspension or closure of operations.

Liability may also extend to downstream companies that use new chemical substances produced or imported without the required registration certificate. These penalties are substantially higher than the fines generally imposed under MEE Order 12.  

In general, MEE Order 40 resolves some of the main uncertainties raised by the June draft, particularly for food, cosmetics, pharmaceuticals, and other sector-regulated products. At the same time, the new Formal Registration for low-volume substances and qualified polymers, restrictions on foreign registrants, and higher penalties require companies to review their China supply chains and registration arrangements.

As MEE Order 40 became effective upon publication, companies should promptly assess whether their substances are subject to the new registration framework and confirm the appropriate compliance pathway.

Keller and Heckman will continue to monitor MEE’s implementation of the amended regulation and related technical guidelines. If you have any questions regarding new chemical substance registration in China, please do not hesitate to contact David J. Ettinger (ettinger@khlaw.com), Chen Hu (hu@khlaw.com), Sharon Tian (tian@khlaw.com), or your existing contact at Keller and Heckman LLP. 

[1] https://www.mee.gov.cn/xxgk2018/xxgk/xxgk02/202610/t20261027_1184708.html 
[2] https://www.mee.gov.cn/gzk/gz/202112/P020211211660802464122.pdf 
[3] https://www.mee.gov.cn/xxgk2018/xxgk/xxgk06/202608/t20260804_1163416.html 
[4] https://www.mee.gov.cn/ywgz/fgbz/fl/202603/t20260313_1146496.shtml