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Ministry of Ecology and Environment (MEE) of China published the revised law for new chemical substances on May 7, 2020, which is said to be replacing the existing legislation, MEP Order 7, from Jan 1, 2021. The new update focuses on the major changes that MEE Order 12 has introduced and their implications for the industry from a legal standpoint. Let us have a brief look at it.
Scope
According to MEE Order 12, the following must submit notification:
- New chemical substances i.e., the substances that do not fall under the Inventory of Existing Chemical Substances (IECSC)
- Existing chemical substances with new uses
If there is an addition of any highly hazardous new substances to the inventory under Order 12, they will be permitted for specific uses only.
If a company wishes to manufacture, use, or import the substance within the 'People’s Republic of China', it must submit a new chemical substance notification for new use management.
Types of Registration
The types of registrations remain unchanged whereas the tonnage thresholds triggering them are altered as follows:
- Standard Registration – For new substances greater than or equal to ten (10) tons a year
- Simplified Registration – For new substances between one (1) and ten (10) tons a year
- Filing – For new substances less than one (1) ton a year and certain specified polymers (E.g. low concern polymers) irrespective of the volume
Technical Review
After the application is accepted for regular/standard registration, the expert committee conducts a technical review, which mainly focuses on the following:
- Name and identification of the new chemical substance
- Quality of the new chemical substance
- Environmental exposure and environmental risks of new chemical substances
- Environmental and health hazards of new chemical substances
- Implementation of environmental management for new uses for existing chemical substances
- Appropriate environmental risk control measures
- Protecting trade secrets
- Application activities for highly hazardous chemical substances
For simplified registration, the technical review mainly focuses on the following:
- Name and identification of the new chemical substance
- Quality of the new chemical substance
- Persistence (P), bioaccumulation (B) and toxicity (T) of new chemical substances
- Environmental risks of new chemical substances
- Protecting trade secrets
According to the new legislation, the maximum protection period of confidential business information (CBI) for new substances is five (5) years from the date of first registration. There will be no extension beyond the tenure.
The protection period for substances that are listed on the inventory with CBI claims will end on Dec 31, 2025, which means that the IECSC will be a full public inventory from Jan 1, 2026.
The MEE is currently working on guidance for new chemical substance notification to provide data requirements and notification procedures in detail. Hence, companies must closely monitor the upcoming guidelines for comprehensive knowledge on registrations. Stay Compliant.
