MEE Order No . 12 & compliance in China
Kaiji Zhang , chemical regulatory affairs consultant at CIRS , looks at the way China ’ s Provisions on Environmental Administration of New Chemical Substances have recently changed
China has implemented the Provisions on Environmental Administration of New Chemical Substances since 2003 , with the aims of controlling the environmental risks of new chemical substances , and protecting human health and the environment . Prior to the manufacture or import of any new chemical substance that is not listed in the ‘ Inventory of Existing Chemical Substances in China ’ ( IECSC ), companies must notify it to the Solid Waste & Chemicals Management Centre and obtain a new chemical substance environmental administration certificate .
To strengthen the management of new chemical substances , the Ministry of Ecology & Environment ( MEE ) released the Revised Provisions on Environmental Administration of New Chemical Substances ( MEE Order No . 12 ) on 29 April 2020 . This came into effect on 1 January 2021 . In addition , the Guidance Documents for New Chemical Substance Notification , a significant supporting document for Order No . 12 , specifying the details of registration implementation , was released on 17 November 2020 . Compared with the previous version of the Provisions on Environmental
Administration of New Chemical Substances ( MEP Order No . 7 ), the management of new chemical substances is significantly changed in a number of important ways Figure 1 ). In terms of notification scope , the Guidance Documents stipulate the following new rules :
• Pharmaceuticals and veterinary drugs ( including APIs ) and pesticides ( including technical materials ) are not subject to notification
• Chemical substances produced by chemical reactions of products or formulations with specific functions ( such as adhesion
MEP Order no . 7 |
|
|
MEP Order no . 12 |
Scientific research record filing |
|
|
Record |
Simplified notification |
Special condition
Basic condition
|
Except PPORD 1-10 tpa
PPORD 1-10 tpa
|
• < 1 tonnes / year
• Polymers with new monomers / reactants concentration < 2 % or PLC
|
Level I : 1-10 tonnes / year Simplified registration
Typical notification
Level II : 10-100 tonnes / year
Level III : 100-1000 tonnes / year
• 1-10 tonnes / year
Regular registration
Level IV : 1000 + tonnes / year
• > 10 tonnes / year
Figure 1 – Comparison of registration type between MEP Orders No . 7 & 12
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