China MEE Order

Supporting the full process, from appointing a Chinese Representative through to testing, dossier preparation, and submission.

China MEE Order 12

MEE Order 12 (China REACH) The Measures for the Environmental Administration Registration of New Chemical Substances is the main chemical regulation in China. The competent authority of MEE Order 12 is the Ministry of Ecology and Environment (MEE). MEE Order 12 regulates “new substances” as single chemical substances, in mixtures or articles with an intentional release. The exemptions under Order 12 are summarised in Section 1.1 of the Guidance for MEE Order 12 (e.g. naturally-occurring substances).

Under MEE Order 12, any substance that is manufactured or imported into China and is not listed on the IECSC must be registered before any handling, production, or import takes place. The regulation applies broadly to research, manufacture, import, and processing of new chemical substances. Business activities involving such substances are not permitted until registration approval has been granted.

Who needs to register?

  • Chinese manufacturers and importers
  • Chinese downstream processing users
  • Foreign companies placing new chemical substances on the Chinese market, via an Only Representative (OR)

Chinese companies may submit registrations directly. Overseas companies must appoint a China-based Only Representative, who holds a legal entity in China and shares responsibility for registration and post-registration compliance.

Our services

We provide end-to-end support for chemical regulatory compliance, including:

  • Regulatory consulting and strategy
  • Only Representative services
  • IECSC search and inventory listing
  • New chemical substance registration (all types)
  • Data assessment, gap analysis, and PBT evaluation
  • Non-testing assessments (QSAR, read-across, toxicokinetics)
  • Test monitoring and risk assessment reports
  • Communication with authorities and expert support
  • Document translation for registration
  • Post-registration compliance (annual reports, certificate renewal)
  • Customised training programs
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Expert consultants

With over 10 years of experience in global chemical registrations, Yordas supports a wide range of substances, including mono- and multi-constituents, UVCBs, and nanomaterials. Our expertise spans substance and dossier preparation, as well as generating new data required for regulatory submissions.

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Client focused delivery

We manage the entire registration process on your behalf, ensuring a seamless path from data preparation to approval. The result is a faster, smoother market access for your products worldwide.

Our Process

Step 1

Check substance status

Step 2

Confirm annual volume

Step 3

Assess substance properties

Step 4

Identify data needs

Step 5

Prepare and submit the dossier

Step 6

Review and post-registration obligations