Overview of Chemical Regulations in China

China

Overview of Chemical Regulations in China

Little Pro on 2015-12-28

In China, industrial chemicals are mainly regulated by the following regulations:

Decree 591 - Regulations on Safe Management of Hazardous Chemicals;
MEE Order 12 - The Measures for Environmental Administration Registration of New Substances;
SAWS Order 53 - The Measures for the Administration of Registration of Hazardous Chemicals;
MEP Order 22 - The Measures for Environmental Administration Registration of Hazardous Chemicals (revoked in July 2016);
Dozens of other supporting regulations or national standards issued by various ministries.

The picture below shows the relationship between above regulations.

Chemical Control Law in China

There are other regulations for chemical weapon precursors, highly toxic chemicals and drug precursor chemicals. Please read "How Are Chemicals Regulated in China by Lists?" for more info.

Decree 591 - Regulations on Safe Management of Hazardous Chemicals

The Regulations on Safe Management of Hazardous Chemicals (known as Decree 591) was published by the State Council of China on 11 March 2011 and entered into force on 1 Dec 2011. Decree 591 is the highest chemical control law in China and it regulates hazardous chemicals through the entire supply chain, from manufacture and importation to distribution and storage, transportation and use.

Decree 591 require businesses who handle hazardous chemicals in China to apply for licenses to operate (“license system”) and submit HazChem registrations separately to two ministries (“HazChem registration”). Decree 591 also implements GHS in China requiring companies to provide SDSs and labels prepared in accordance with relevant national standards.

MEP Order 7 - The Measures for Environmental Management of New Chemical Substances (China REACH)

The Measures for Environmental Administration of New Chemical Substances (MEP Order 7) was issued by China MEP in Jan 2010 and came into force on 15 Oct 2010. This regulation is similar to EU REACH and is also known as "China REACH". It has been replaced by MEE Order 12 issued in 2020.

MEP Order 7 requires that manufacturers and importers of new substances notify new substances and obtain approval from China MEP prior to production or importation. A foreign exporter may appoint a Chinese agent to submit notifications.

SAWS Order 53 - The Measures for the Administration of Registration of Hazardous Chemicals

The revised Measures for the Administration of Registration of Hazardous Chemicals (SAWS’s Order 53) was issued in July 2012 and came into force on 1 Aug 2012. The regulation is promulgated in accordance with the article 66 and 67 of Decree 591 and sets out detailed requirements on HazChem registrations with the State Administration of Work Safety (SAWS).

SAWS’s Order 53 requires that domestic manufacturers and importers register hazardous chemicals with the National Registration Center of Chemicals (NRCC) of SAWS prior to manufacturing or importation. Compared to the old measures, it has triggered new obligations for importers and required more detailed hazard data from companies for registration as well as a 24h emergency contact number.

MEP Order 22 - The Measures for Environmental Administration Registration of Hazardous Chemicals

The trial Measures for Environmental Administration Registration of Hazardous Chemicals (MEP Order 22) was issued by China MEP in Oct 2012 and came into force on 1 March 2013. This regulation is promulgated in accordance with the article 6 of Decree 591 and is MEP’s version of HazChem registration in China.

Under MEP’s order 22, manufacturers and companies who use hazardous chemicals to manufacture products (“user”) in China shall register hazardous chemicals listed in the Catalogue of Hazardous Chemicals with local environmental protection authorities and obtain environmental administration registration certificates.

GHS in China

China has fully implemented GHS for all hazardous substances and mixtures from 1 May 2011. Various national standards have introduced GHS classification criteria to China and set out detailed requirements on the content and format of SDSs and labels.

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