The Revised Provisions on the Environmental Administration of New Chemical Substances 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 The current Provisions on the Environmental Administration of New Chemical Substances (MEP Decree No. 7) will be repealed simultaneously.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 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 registrations.
The regulation and exemption scope has been 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
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 (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 and fourth level of typical notification (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 the substances and the actual needs;
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.
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, 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.
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.
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 monitoring the situation and keep updating the compliance of China new chemical substance regulation.