The Revised Provisions on the Environmental Administration of New Chemical Substances (hereinafter referred to as Revised Regulation) was published on 29 Apr. 2020 and will be implemented from 1 Jan. 2021. The current Provisions on the Environmental Administration of New Chemical Substances (MEP Decree No. 7) will be repealed simultaneously.
The current Provisions on Environmental Administration of New Chemical Substances (MEP Decree No.7)(China REACH) took effect on 19 Jan. 2010 and it has been implemented for nearly 9 years. This regulation is also named ‘China REACH’ for short, although it only requires new substance notification rather than EU REACH requires all chemical registration.
Compared with the current Regulation, the Revised Regulation has been significantly changed in the following aspects:
The regulation and exemption scope is revised
- The Revised Regulation does not apply to new chemical substances that are stored in Customs Supervision Area and will be exported without any processing;
- In terms of finished products that are supervised by other laws and regulations, if these products are to be used for other industrial purposes, then the Revised Regulation will apply.
The type and scope of registration has been revised
Comparison of Registration Type and Scope between the Current Regulation and the Revised Regulation
Scientific Research Record
For scientific research; less than 0.1t/a
1. Less than 1t/a;
2. Monomers of new substances, polymers containing less than 2%w/w new substances and polymers of low concern;
Simplified Notification under Specific Condition
1. Intermediates, less than 1t/a;
2. For export only, less than 1t/a;
3. Scientific research, 0.1-1t/a
4. Monomers of new substances, polymers containing less than 2%w/w new substances and polymers of low concern;
5. For technical and product research, the annual production or imports shall be no more than 10t (up to 2 years)
Simplified Notification under Basic Condition
Less than 1t/a
Typical Notification First Level
Typical Notification Second Level
More than 10t/a
Typical Notification Third Level
Typical Notification Fourth Level
More than 1000 t/a
- Substances currently subject to scientific research record and simplified notification will be subject to record under the Revised Regulation; Enterprises can carry out business activities once they submit the completed record materials;
- Substances currently subject to first level of typical notification (in volumes between 1-10t/a) will be subject to simplified registration under the Revised Regulation; the data requirements as well as the registration process for simplified registration will be reduced under the Revised Regulation;
- Substances currently subject to second, third or fourth level of typical notification (in volumes over 10t/a) will be subject to regular registration under the Revised Regulation; data requirements for substances subject to regular registration substance will be variable depending on the environmental risks of these substances and the actual needs;
Note: In Draft
Regulation released on 9 Jul. 2019, scientific research record has been
canceled; but according to the Revised Regulation released on 29 Apr. 2020,
scientific research record is still available. That is to say, substances for
R&D purposes with the tonnage less than 0.1t/a can still complete
scientific research record.
New usages management for PB, PT, BT and highly hazardous substances
New uses of substances that are persistent and bio-accumulative (PB), persistent and toxic (PT), bio-accumulative and toxic (BT) or highly hazardous will be managed.
- In terms of substances that are considered PB, PT or BT, when these substances are included into IECSC, the government will rule the approved uses of these substances. All applicants must apply for new use registration to the competent authority if they need to use these substances for different purposes.
- In terms of highly hazardous substances listed in IECSC, new applicants need to apply for new use registrations.
Procedures for IECSC supplementation is optimized
Procedures for supplementation of Inventory of Existing Chemical Substances in China (known as IECSC) are optimized under the Revised Regulation:
- Under the current regulation, new substances will be added into IECSC and be regulated as existing substances five years after the date they are imported or produced for the first time;
- Under the Revised Regulation, new substances will be added into IECSC and be regulated as existing substances five years after the date they are registered for the first time.
Highly hazardous substances must demonstrate the necessity of activity
Highly hazardous substances refer to substances that are considered persistent, bio-accumulative or toxic (PBT); or substances that are very persistent and very bio-accumulative (vPvB). When enterprises apply for registration for this kind of chemical substances, they need to provide socio-economic analysis to demonstrate the necessity of registration.
Compared with the current Regulation, the Revised Regulation does not require enterprises to submit each activity report and five-year activity report. But enterprises still need to submit first activity report and annual report.
Under the Revised Regulation, time of submission and scope of report are adjusted: applicants will only need to submit annual activity report of last year when they are required.
Under the Revised Regulation, if enterprises need to apply for protection of CBI, they must submit documents to demonstrate the necessity of CBI protection. The time limit for CBI protection is no more than 5 years.
If the substances have been listed into the Inventory of Existing Chemical Substances in China before the implementation of the Revised Regulation and information is already under protection, then the information protection period will be expired on 31 Dec. 2025 (at the latest)
The Revised Regulation also clarifies enterprises’ key responsibilities; increases the responsibilities and obligations of agents; and revises the circumstances where enterprises need to re-register.
CIRS warmly reminds that the registration of new chemical substances in China will be tremendously changed after the implementation of the Revised Regulation. The supporting documents which rule the data requirements are still under revision. CIRS will continue to pay attention to the revision of the supporting documents and provide China new chemical substance regulatory compliance services to clients.
If you have any needs or questions, please contact us at firstname.lastname@example.org.