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China Issues Final Guidance on New Chemical Substance Registrations

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December 8, 2020

On November 16, 2020, China’s Ministry of Ecology and Environment (MEE) issued the Guidance on Registration of New Chemical Substances for Environmental Management, which will replace the current Guidance issued by the former Ministry of Environmental Protection (MEP) in 2010.

The Guidance has been updated to implement the new Measures on Registration of New Chemical Substances for Environmental Management published by the MEE in April 2020. The new Measures and Guidance will enter into force on January 1, 2021.

The revisions to the Guidance are based on the changes introduced by the new measures, and readers can find the key changes to the Measures in our earlier blog article: China Issues Final Measures on Registration of New Chemical Substances for Environmental Management. The Guidance provides additional clarifications to the following aspects:

Scope

The Guidance refines the scope of new chemical registrations with medicines (including active pharmaceutical ingredients), pesticides (including technical material) and fertilizers out of the scope of the registration requirements. Additional exemptions have been introduced. For instance, if a chemical substance in anhydrous form has been included in the “Inventory” or has been registered, its hydrates are considered an existing substance, and vice versa.

Registration Certificate Holder

The current 2010 version indicates that, after obtaining the registration certificate, the Chinese agent will be listed on the certificate as the registration certificate holder. However, the foreign applicant will be the registration certificate holder under the new Guidance. The registration certificate holder and the Chinese agent shall jointly bear the responsibility of new chemical substance registrations and post-registration obligations for environmental management.

Minimum Data Requirements

The Guidance provides the minimum data requirements for different registration types, including:

  • Physical chemical properties (for simplified registrations and regular registrations);
  • Toxicological properties containing both basic data requirements and data specially required for highly hazardous chemical substances (for regular registrations);
  • Eco-toxicological properties containing both basic data requirements and data specially required for highly hazardous chemical substances (for simplified registrations and regular registrations).

Polymers

According to the Measures, new polymers containing less than or equal to 2% new monomers or which are “low concern polymers” can be submitted to the MEE for record-keeping with much reduced application requirements. However, readers should be aware of the following five exclusions of polymers:

  • Cationic polymers or polymers that are anticipated to become a cationic polymer in a natural aquatic environment;
  • Degradable or unstable polymers;
  • Water absorbing polymers with number average molecular weight 10,000 and greater;
  • Certain types of fluoropolymers;
  • Polymers that do not meet certain elemental limitations.

These excluded polymers are not qualified for the record-keeping filing prior to import/manufacture, and they will be subject to simplified or regular registrations.

Recommended Action Items:

  • Learn how the new Measures and Guidance will affect your products and plan ahead for the January 1, 2021 implementation date.

References:

MEE Order No. 12, “Measures on Registrations of New Chemical Substances for Environmental Management” (生态环境部部令第12号, 新化学物质环境管理登记办法, only available in Chinese): http://www.mee.gov.cn/xxgk2018/xxgk/xxgk02/202005/t20200507_777913.html

Guidance for New Chemical Substance Registrations for Environmental Management (新化学物质环境管理登记指南): http://www.mee.gov.cn/xxgk2018/xxgk/xxgk01/202011/t20201119_808843.html

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