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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 This regulation came into force on 1 January 2021 and the previous regulation (MEP Order No.7) was simultaneously repealed.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 published a notification on the enforcement of toothpaste regulation
NMPA published a notification on the enforcement of toothpaste regulation

On 25 September 2023, the National Medical Products Administration (NMPA) published a notification on the enforcement of toothpaste regulation and simplified the information requirements for toothpaste products which have already done...

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China published children cosmetic technical guidance
China published children cosmetic technical guidance

On 31st August 2023, the National Institute for Food and Drug Control of China (NIFDC) published the Technical Guidance Principles on Children Cosmetic Products. This guidance was enforced since 31st August...

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