China’s MEE Order No. 12: Key Draft Changes to New Chemical Substance Registration
- 3 days ago
- 3 min read
China is revising its rules on new chemical substance registration, with a draft revision of the Measures for the Environmental Management Registration of New Chemical Substances, commonly referred to as China REACH.
The draft was released by China’s Ministry of Ecology and Environment on 11 June 2026 and was open for public comment until 12 July 2026. Once finalised, the revised measures are expected to replace MEE Order No. 12 of 2020.
For companies placing substances or products on the Chinese market, the proposed changes could have a significant regulatory impact, especially where new chemical substances are involved.
What is MEE Order No. 12?
MEE Order No. 12 sets out the requirements for the environmental management registration of new chemical substances in China.
A new chemical substance is generally understood as a substance that is not listed on China’s Inventory of Existing Chemical Substances, known as IECSC.
Companies manufacturing, importing or placing products on the Chinese market may therefore need to assess whether substances used in their products fall within the scope of the registration requirements.
Key proposed changes
The draft revision introduces several important changes to the current registration framework.
1. Exclusion of overseas applicants
One of the most impactful proposed changes concerns who can act as the registration applicant.
Exclusion of Overseas Applicants: Overseas enterprises can no longer act as registration applicants. Only domestic Chinese producers or importers are eligible to apply.
This means that foreign suppliers would no longer be able to act directly as registration applicants. Instead, they would need to rely on a Chinese manufacturer or importer to hold the registration.
For companies exporting products or substances to China, this could have practical consequences for supply chain organisation, regulatory responsibility and market access planning.
2. Removal of several existing exemptions
The draft revision also proposes the removal of several existing exemptions.
According to the information currently available, the affected categories include pharmaceuticals, pesticides, veterinary drugs, cosmetics, food, feed, fertilisers and related additives.
Companies active in these sectors may therefore need to reassess whether they have additional obligations under China’s new chemical substance registration framework, even if their products are already subject to sector-specific regulations. This point is particularly important for companies that previously considered their products outside the scope of MEE Order No. 12 due to an existing product-category exemption.
3. Changes to registration categories
The draft also proposes changes to the current registration procedures.
Under the current system, Record Filing applies to certain lower-volume new chemical substances and eligible polymers. The draft revision would replace Record Filing with Simplified Registration. This means that substances that previously benefited from a lighter record filing process may become subject to an approval-based registration process.
Companies currently relying on Record Filing should therefore review whether their substances may require a new registration approach once the revised measures enter into force.
Why does this matter for companies doing business in China?
The proposed changes could affect companies across several sectors, particularly those manufacturing, importing or supplying products containing new chemical substances to the Chinese market.
The main points to monitor are:
Companies may need to reassess whether their substances fall within the scope of China REACH.
Foreign companies may need to work more closely with Chinese importers or producers, as overseas applicants would no longer be eligible to apply directly.
Products previously covered by exemptions may need to be reviewed again.
Substances currently managed through Record Filing may require Simplified Registration.
These changes could affect regulatory timelines, responsibilities between suppliers and importers, and the ability to place certain products on the Chinese market.
What should companies do now?
Companies potentially affected by the draft revision should start by identifying whether they manufacture, import, export or supply products containing substances that may be considered new chemical substances in China.
They should also review their current registration status, their use of existing exemptions, and the role of their Chinese importers or local partners in the registration process.
As the final version of the revised measures has not yet been published, companies should continue monitoring regulatory developments and prepare for possible changes to their compliance strategy.
CEHTRA is following the situation
CEHTRA is closely monitoring the revision of MEE Order No. 12 and its potential impact on companies doing business in China.
For any questions on this topic, please contact Damien Guyomar