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China MEE Order 12 - The Measures for the Environmental Administration Registration of New Chemical Substances

Little Pro on 2020-12-16

The Chinese Ministry of Ecology and Environment (MEE) issued its Order 12 - The Measures for the Environmental Administration Registration of New Chemical Substances in 2020. It replaces China MEP Order 7 and comes into force on 1 Jan 2021.

The new regulation continues requiring new chemical substance notifications but strenghthens the management of persistent (B), bio-accumulative (B) and toxic new chemical substances and sets the non-approval criteria for new chemical substances meeting PBT criteria and reduces requirements for some polymers of low concern, <10t/y new substances and intermediates.

Scope and Exemptions

The new regulation requires the following substance to be notified:

  1. New substances, i.e., substances not listed on IECSC.
  2. Existing substances listed IECSC but subject to new use management (i.e, similar to TSCA SNUR).

When MEE adds a notified new substance to IECSC, they may specify permitted uses for the new substance in IECSC if the new substance is highly hazardous. Even after the substance gets listed on IECSC with a specified, anyone who wishes to manufacture, import or use the substance for a different use still needs to submit new chemical substance notifications.

The following chemical substances are out of scope:

  1. Chemical substances subject to other existing laws and regulations (pharmaceuticals, pesticides, cosmetics, food additives, etc.);
  2. Naturally occurring substances;
  3. Impurities (content of a single impurity <10%w/w, total content of all impurities<20%w/w), waste or by-products;
  4. Special categories such as glass, cement, alloys, non-isolated intermediates (*), articles.

Notification Body

Under MEP order 7, only manufacturers and importers can notify new chemical substances. Under the new regulation order 12, downstream users can also notify new substances when:

  1. they use exempt substances (pharmaceuticals or pesticides) for industrial uses; or
  2. they use an existing substance subject to new use management in a way different to specified uses in IECSC.

In addition, foreign traders who export new substances to China can also notify. However, they must appoint local representatives to submit new substance notifications and the local representatives must take legal responsibilities on behalf of the foreign traders or manufacturers. 

Notification Type

Under the new regulation, there are still three types of notifications. The notifications of <10t/y new substances and polymers are further simplified. 

  1. Regular notification: >=10t/y new substances 
  2. Simplified notification: 1-10t/y new substances (Under MEP order 7, even 1-10t/y requires regular notifications). 
  3. Record filling notification: <1t/y new substance, polymer meeting 2% rule and polymer of lower concern (Under MEP order 7, polymers of low 

Record filling notification is easy because it does not require explicit ministry approval. You can start relevant activies (production, import or use) as soon as you submit needed information/documents. No testing data is needed for this type of notification.

For simplified notification and regular notification, test data (pchem,tox and environmental data) needs to be submitted. Overall data requirement depends on whether a substance can meet persistence (P) or bio-accumulative(B) criteria.

Procedure for Adding Notified New Substances to China

Under the new regulation, notified new substances will be added to IECSC 5 years since its approval date. This is in contrast to 5 years since the date of the first production/import under current China MEP order 7. Note: only new substances notified with regular notifications qualify for IECSC listings. 

When adding new substances meeting PB, PT or BT critiera to IECSC, the MEE will aso specify allowed uses for them in IECSC. These substances will be subject to new use management rules and require notifications if they are used for a different purpose.

Annual Report

Under the new regulation, not all notified new substances require annual reports. Only those  new substances meeting PB, PT or BT critiera or high hazard substances require annual reports and such requirements will be specified in registration certificates. The deadline for annual report has also been extended from 31 Jan each year to 30 Apr each year. 

Confidential Business Information Protection

Under the new regulation, the maximum protection period of confidential business information for new substances (i.e, substance identity) is 5 years and this cannot be extended.

For all substanes listed on IECSC with CBI claims, the protection period will end on 31 Dec 2025. This means that IECSC will become a full public inventory from 1 Jan 2026.

Reference

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 Tags: Topics - ChinaREACH-like Regulation and Registration

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