China’s Ministry of Ecology and Environment (MEE) has today published the final legal text of the country’s revised overarching regulation governing new chemical substances.

The new MEE Order 12 replaces the current MEP Order 7 and will come into force on 1 January, when the existing Order will be repealed.

The government approved the revisions to the regulation (unofficial English title, New Chemical Substance Environmental Management Registration Measures)  on 17 February.

The revised regulation:

• strengthens the management of persistent (P), bioaccumulative (B) and toxic (T) new chemical substances;

• sets out the conditions when the government will not approve new chemical substances that meet PBT criteria;

• reduces requirements for some polymers of low concern and registration of new substances manufactured or imported in volumes of less than ten tonnes a year; and

• introduces a notification process for new uses of existing listed substances, similar to the significant new use rule (Snur) under the US Toxic Substances Control Act (TSCA).

If a new substance meets all three criteria – P, B and T - the MEE will not approve it. If it meets two – PB, BT, or PT – the substance can be approved but with conditions such as annual reporting and inclusion in the Inventory of Existing Chemical Substances (IECSC) with use restrictions.

Under the current MEP Order 7, there are no criteria outlining how the government will refuse approval for new substances.

Scope

The regulation requires the following to be notified:

• new substances – these are substances not listed on the existing inventory; and

• new uses – this covers existing substances that are listed on the inventory but are subject to new use management. 

Under Order 12, when the MEE adds a highly hazardous new substance to the inventory, it will specify its permitted uses.

Any company wishing to manufacture, use or import the substance for a different (non-specified) use will need to submit a new chemical substance notification for new use management. 

Order 12 clarifies that fertilisers are out of scope of the regulation.

Notification type

Like MEP Order 7, the revision contains three types of notifications: 

• regular notification – for new substances imported or manufactured in volumes greater than ten tonnes a year; 

• simplified notification – substances manufactured or imported in volumes between one and ten tonnes a year (under MEP Order 7, these substances require regular notification); and 

• record filing notification – this is for new substances in volumes of less than one tonne, polymers that meet the ‘2% rule’, and polymers of low concern.

Record filing notification does not require explicit ministry approval. Companies can begin production, import or use as soon as they have submitted the necessary information and documents to the MEE. 

The small volume exemption for substances used for R&D purposes in volumes under 100kg contained in the draft version of the revised regulation has been removed from the final version.  

The revised regulation also extends the notification provisions from manufacturers and importers to downstream users, which can notify new substances when:

• they use exempt substances (pharmaceuticals or pesticides) for industrial uses; or

• they use an existing substance in a different way to the use specified in the inventory.

In addition, foreign traders exporting new substances to China can also carry out the notification process. However, they must appoint local representatives to submit new substance notifications and the representatives must assume legal responsibilities on behalf of the foreign trader or manufacturer. 

CBI protection

The revised regulation allows a maximum protection period of confidential business information (CBI) for new substances of five years, which cannot be extended. 

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

Inclusion on existing inventory

Under Order 12, notified new substances will be added to the IECSC five years from the date of approval. 

Only new substances notified with regular notifications qualify for IECSC listings. As with the current MEP Order 7, simplified notification substances are not added onto the inventory and always remain as new substances. 

Annual reporting

The new regulation reduces the requirements for annual reporting. Under MEP Order 7, companies are required to submit annual reports for the majority of new substances, regardless of their hazard or risk. 

Under the new regulation, companies are only required to submit annual reports for those new substances meeting PB, PT or BT criteria or highly hazardous substances and such requirements will be specified in the registration certificate. 

The MEE is currently working on guidance for new chemical substance notification, which will provide more information on data requirements and detailed notification procedures. 

Source from chemicalwatch