The management of new chemical substances in China

Background

In China, new chemical substances are managed in a system where “companies apply and register chemical substances for themselves”, based on the Measures on the Environmental Management of New Chemical Substances and the Guidelines on the Reporting and Registration of New Chemical Substances as well as the inventory. The application and registration status of new chemical substances are kept updated on the website of the Ministry of Ecology and Environment of China. A public notice is issued for each reported substance; it gives the receipt number, Chinese name of the substance, applicant (a person or a company), application type and management type.

In China, the Ministry of Ecology and Environment is in charge of the new chemical substance management as supervisory body, while the Solid Waste and Chemical Management Technology Center of the ministry is in charge of the daily management of the substances as well as acceptance, processing, etc. of submitted documents.

In addition, physicochemical property tests, toxicological tests and ecotoxicological tests are conducted in accordance with the Measures on the Environmental Management of New Chemical Substances. At present, there are only 11 testing facilities approved by the ministry.

Ministry of Ecology and Environment of China Public Notice No. 77 of 2012, accrediting 8 testing facilities.
http://www.mee.gov.cn/gkml/hbb/bgg/201212/t20121231_244522.htm

Ministry of Ecology and Environment of China Public Notice No. 5 of 2015, accrediting 3 testing facilities.
http://www.mee.gov.cn/gkml/hbb/bgg/201502/t20150206_295578.htm

 

Transition to the Measures on the Environmental Management “and Registration” of New Chemical Substances

The ministry announced the amended Measures on the Environmental Management and Registration of Chemical Substances, in the Ministry of Ecology and Environment Decree No. 12 of April 29, 2020. The new Measures will come into effect on January 1, 2021. On the same day, the current Measures (announced on 19 January, 2010, formerly known as Regulation No. 7 of the Ministry of Ecology and Environment) will be abolished.

This amendment has attracted attention since the public comment period, and significant changes have been introduced since Regulation No. 7 and the draft for comments.

 

Guidelines on the Reporting and Registration of New Chemical Substances (issued on September 16, 2010)

The guidelines describes the reporting procedure in detail. They cover six items: scope, reporting types and formats, reporting and registration procedures, reporting documentation requirements, special provisions for polymers, and management and supervision after reporting and registration. The guidelines are mainly applied to reporters or their agents of new chemical substances.

Some changes were made to the reporting items on October 15, 2017. You can get more details in this original text (in simplified Chinese):
http://www.mee.gov.cn/gkml/hbb/bgg/201709/t20170905_420903.htm

 

China’s Inventory of Existing Chemical Substances (IECSC)

There are 45,612 substances in the current 2013 inventory. Of these, 42,342 substances give their molecular formula, CAS number or serial number in addition to the Chinese and English names, and 3,270 substances are listed under data protection (trade secret protection) without a molecular formula or CAS number. A total of 307 substances have been added to the inventory since its release in the following 5 rounds.

Announcement date Overview Link to the original announcement
March 10, 2016 31 substances
9 of them are classified as Hazardous Substances for Priority Environmental Management.
http://www.mee.gov.cn/gkml/hbb/bgg/201603/t20160315_332884.htm
November 22, 2018 45 substances
6 of them are confidential.
http://www.mee.gov.cn/xxgk2018/xxgk/xxgk01/201811/t20181130_676779.html
January 14, 2019 28 substances http://www.mee.gov.cn/xxgk2018/xxgk/xxgk01/201901/t20190117_689881.html
January 3, 2020 47 substances http://www.mee.gov.cn/xxgk2018/xxgk/xxgk01/202001/t20200113_758915.html
May 6, 2020 156 substances http://www.mee.gov.cn/xxgk2018/xxgk/xxgk01/202005/t20200508_778159.html

 

Regulation on the Environmental Risk Assessment and Management and Control of Chemical Substances (draft for notification)

On January 8, 2019, the Ministry of Ecology and Environment of China announced the Regulation on the Environmental Risk Assessment and Management and Control of Chemical substances (draft for comments) to solicit opinions until February 20. Subsequently, in September 2019, the ministry submitted a draft for notification of the regulation in accordance with the WTO’s Technical Barriers to Trade (TBT) Agreement.

Compared to the “draft for comments” released in January, the “draft for notification” submitted in September has an expanded scope of exemption and has adjusted the current risk assessment system and risk control measures for chemical substances as well as the environmental management and registration system for new chemical substances.