China MEE issued ‘Provisions on Environmental Administration of New Chemical Substance Management of China’ (China REACh) (Order [2020] No. 12) on May 7^th, 2020.

 

 

The formally enacted Provisions has no much difference from the draft version.

 

 

MEE linkage: www.mee.gov.cn/xxgk2018/xxgk/xxgk02/202005/t20200507_777913.html

 

 

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China MEE issued ‘Provisions on Environmental Administration of New Chemical Substance Management of China’ (China REACh) (draft for public comments) on July 9^th. Deadline for comments is Aug. 16, 2019.

 

 

In Oct 2016, ‘Guidance for New Chemical Substance Notification and Registration’ (draft for public comments) issued by MEP (previous name of MEE) made some substantive modification to new chemical registration types. However, due to the fact that a Guidance can only serve to the Provisions which is its upper level Regulation, can not modify its requirement, the 2016 draft ‘Guidance’ was finally not enacted.

 

 

This time the new draft version of the Provisions adopts the idea of the 2016 draft Guidance: to simplify data and registration requirement, and to strengthen somehow risk-analysis/management. This is also in compliant with the content of the new chemical registration part in the ‘Regulations on Chemical Environmental Risk Assessment and Controls’ (draft for public comments) issued by MEE in January 2019.

 

 

Comparing to the current Provisions (effective from Oct. 2010, Order No. 7), main changes include,

1     For registration types:

1.1    <100kg/year: exempted (previously: Scientific Record Notification or Simplified Registration).

1.2    100~1000kg/year and 2% rule polymers: Scientific Record Notification (Simplified Registration).

1.3    1~10 ton/year: Simplified Registration (previously: Level 1 Typical Registration).

1.4    1~10 ton/year (Process and Product Development & Research, valid for 2 years): probably not applicable anymore (Previously: Simplified Registration)

1.5    > 10 ton/year: Typical Registration without level bands anymore (previously: Level 2~4 registration)

2     Data Requirement

Test data requirement will be reduced, but requirement for persistant/bioaccumulative/toxic substance will probably be enhanced and necessity for introducing such new substance will be challenged.

3    CBI on Chemical Identification

CBI will be allowed only for 5 years, afterwards chemical identification (chemical name, CAS No., etc.) will be publicized.

If reason or argument is judged un-sufficient, CBI on chemical identification or even the registration maybe denied.

4    Annual Report

Annual Report will be required only to certain Typical Registration substances (high risk substances).

 

Original Notice (Chinese): http://www.mee.gov.cn/xxgk2018/xxgk/xxgk06/201907/t20190711_709145.html