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The main legislations governing the chemical market in China is Order No. 12 of the Ministry of Ecology and Environment (MEE), Measures for the Environmental Management Registration of New Chemical Substances, also known as MEE Order No.12. This regulation came into force on 1 January 2021 and the previous regulation (MEP Order No.7) was simultaneously repealed.

Anyone who wants to research, produce, import, or process new chemical substances in China has to register before carrying out their activities. They are:

  • Chinese manufactures or importers
  • Chinese processing users
  • Foreign companies who wish to sell new chemical substances in China.

Chinese manufacturers and importers can register the chemical substances themselves. Overseas enterprises, however, must appoint a Chinese agent (Only Representative (OR)) who will share the legal responsibility with them to fulfil the registration and post-registration obligations. The OR should be acknowledgeable and qualified to carry out the registration activities. 

Introduction to China Regulatory Regions

News

NMPA publishes good manufacturing practice ‘specifications’ for cosmetics
NMPA publishes good manufacturing practice ‘specifications’ for cosmetics

Based on the China cosmetic regulation (Cosmetics Supervision and Administration Regulation, CSAR), the National Medical and Pharmaceutical Agency (NMPA) published the good manufacturing practice ‘specifications’ for cosmetics. This notification was published...

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MEE adds 11 chemicals to IECSC
MEE adds 11 chemicals to IECSC

On 22nd December 2021, the Ministry of Environment and Ecology announced that 11 chemical substances will be added to the Inventory of Existing Chemical Substance list (IECSC) of China. For chemicals...

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