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The draft Regulation on Chemical Substance Environmental Risk Assessment and Control was issued on 8 Jan, with the ambition to comprehensively manage chemicals, covering both new and existing chemicals in China. The MEE will also establish technical guidance and a database for environmental risk assessment of chemical substances to support the regulation.
This regulation, if promulgated, will be at the same administrative level as Decree No.591 which is currently the overarching regulation for chemical management in China. MEP Order 7 (currently under revision), aka China’s New Chemical Environmental Management Regulation, will also be subordinate to this regulation. It is expected that the revised MEP Order 7 will not be issued before the approval of this regulation. It is uncertain when this regulation will be finalized, which is now only at a preliminary development stage involving soliciting feedback from industry.
Inventory management
The regulation introduces five key lists based on chemical control banding, including:
Inventory of Chemical Substances in China;
List of Chemical Substances subject to Priority Assessment;
List of Chemical Substances subject to Priority Control;
List of Chemical Substances Strictly Restricted; and
List of Prohibited Chemical Substances.
The regulation will operate using the Existing Chemical Inventory, as a reference to delineate new and existing chemicals and impose regulatory compliance obligations on stakeholders according to this broad division. The authority is considering reopening its inventory supplementation program (allow chemicals which are already circulating in the market or fit a specific criteria to be added to the existing inventory and avoid the increased compliance requirements associated with new chemical registration). However, so far no official announcement has been made publicly and there is no definite information as to when the supplementation will start. The only certainty is that the scope would be the same as before i.e. only substances manufactured or imported into China before 15 Oct 2003 would be eligible. There were numerous cases of stakeholders that fulfill supplementation criteria but missed the supplementation deadline due to an inability to obtain sufficient evidence to substantiate the circulation of their chemical in China’s market prior to 2003.
Annual reporting of chemical substances
New requirements mandating reporting of chemical substances is introduced in which manufacturers, downstream processors/users, or importers must report to the MEE the name of substance, use and quantity in the last year. This new requirement will likely see many enterprises flagged for their illegal activities involving the handling of un-notified chemicals classified as “new” under Chinese regulation. The number of existing substances in China (45,000+ substances) is much smaller compared to the European Inventory of Existing Commercial Chemical Substances (EINECS) (100,000+ substances). Notably, there is no small volume exemption drafted for annual reporting.
Environmental risk screening and control
The MEE will organize chemical substance environmental risk screening and publish work plans for risk assessment of priority chemical substances which are persistent, bioaccumulative, or of great hazards to environment or human health, and with high environmental exposure risks. Producers, processors/users, or importers of chemical substances on the List shall report emission data, local environment impact, and necessary physicochemical properties, toxicology, and ecotoxicology data. MEE can request the enterprises to conduct additional tests if the existing information is insufficient for risk assessment.
Substances subject to priority control, strictly restricted substances for import and export, and prohibited substances will be screened out accordingly. In addition, the authority will directly include the substances managed under international conventions.
New chemical
For new chemicals, we will see new requirements imposed including:
A record-keeping system in place of the current simplified notification for (1) new substances manufactured or imported at below 1 ton/year, (2) new polymers containing less than 2% new chemical monomer or polymers of low concern (PLC), and (3) new chemical substances manufactured or imported at below 10 tons/year for no more than two years for product and process orientated research and development (PPORD)
exemptions of new substances used at below 100kg/year for R&D or reference standards from new chemical substance notification
Notably, record-keeping is similar to the Technical Completeness Check in EU REACH, which will free up technical evaluation committee experts from engaging in burdensome technical review work for countless simplified notifications.
Article 24 indicates that the persistent, bio-accumulative and toxic substances (PBT), etc. will not be approved and will be directly classified as prohibited substances. It is unknown if the screening criteria for listing a substance as prohibited will be based on uncontrollable risk or some other criteria.
Legal liability
One chapter of the new regulation deals specifically with the legal liability of officials, experts for review work, testing institutions and enterprises. Especially for enterprises, five aspects are introduced. Enterprises will face increased penalties for breaches of new chemical management rules, which are up to 1 million Yuan for failure to register a substance and up to 2 million Yuan if serious issues occur due to their illegal activities.
The regulation stressed the idea of risk assessment, control and also emphasized the need for source management and control banding. The new regulation represents a complete overhaul of China’s chemical regulatory framework and a massive deviation for industry in terms of their compliance obligations with a huge potential to impact market access for almost all stakeholders. Although the success of Europe’s REACH regulation offers hope for Chinese regulators and industry, the contextual differences between the two regions are stark. Prior to the implementation of REACH many of Europe’s chemical enterprise already had generated data required for compliance with REACH which significantly reduced the negative financial impacts of compliance. Chinese companies will have no such luxury. Additionally, technical capacity issues between the enterprises in both regions are substantial and Chinese enterprise are more poorly equipped to buffer the jarring impact of this new regulation.
