- China is to adopt a regulation on chemical environmental risk assessment and control similar to Canada CEPA, U.S. TSCA and Japan CSCL, rather than a REACH-like regulation.
- The industry welcomes changes to new chemical management.
- For annual reporting, the proposed frequency of reporting and the objects are the subject of heated debate.
- The industry calls for stakeholder engagement, public awareness and transparency.
Although China was initially looking to develop a REACH-like regulation, considering administrative capacity and the administrative burdens inherent in a REACH-like regulation, China is instead opting to use a regulation similar to Canadian Environmental Protection Act (CEPA). The regulation was newly drafted by China MEE, named as the Regulation on environmental risk assessment and control of chemical substances. It will make up for the limitations of Decree No. 591, and it will serve as the overarching regulation of environmental management of existing and new chemicals. The details of the regulation have been reported by ChemLinked, please click here to read more.
For new chemical, measures for reducing the industry’s burden were drafted in this regulation. Only new substances manufactured or imported at or above 1 ton/year require registration, the others will be subject to simple filing or direct exemption. The industry welcomes such changes. The reduced data requirements, revised exemption conditions (issued in Oct 2017) and the proposed adjustment in registration types will greatly facilitate industry compliance.
Annual reporting will give the government a clear picture on the volume and uses of chemicals circulating in the market and will allow the government to dynamically adjust regulatory and supervisory activities and enforcement. However, it brings up another question, will the annual reporting system cover all the industry and the whole supply chain? Considering the fact that reporting substances regardless of volume or hazards will be burdensome, there may be some threshold. It will also help the authority develop screening criteria for priority substances.
However, industry has pointed out that reporting annually will be burdensome, especially if downstream users/processors are also required to report. In addition to having an excessive impact on downstream links in the supply chain, industry has also pointed out that unnecessary duplication of data will be inevitable. For the authority, information on uses of substances is difficult to obtain and information about the exposure arising from downstream use is generally scarce. That’s why regulators want to collect information from downstream users as specified in the draft. The industry expects the reporting frequency to be changed and the compliance burden reduced.
Unlike the mechanism adopted in EU REACH, China MEE will take the responsibility to conduct the environmental risk assessment of the priority substances. Industry will be required to report necessary data, including emission data, local environmental impact, physicochemical properties, toxicology, and ecotoxicology data, etc. China has carried out two national investigations over the environmental situations of chemicals in 2013 and 2016, which lay the foundation for establishing environmental management of chemicals. In addition, the authority has collected qualified data available in international databases, which will allow authorities to reduce requirements to produce data on certain testing endpoints.
The assessment work will be slow and resource-intensive. Compared with the regulatory frameworks of its international counterparties, e.g. Canada CEPA, America TSCA, Japan CSCL, etc., China’s system hopes to identify, screen and assess priority substances quickly. Given that China’s current capacities lag behind its international counterparts, focusing on a larger number of substances would be impractical. So far, there is no idea about specific technical methods. After the promulgation of the regulation, numerous support regulations and guidelines will be released to flesh out practical implementation specifications.
In addition, given the administrative level of this regulation, China’s government is likely to allocate a large number of resources to improve inspection and ministerial cooperation. In the draft regulation, MEE only outlines its own responsibilities. For other relevant ministries, the details are currently being developed. No information about customs inspections of new chemicals has been released yet.
Risk assessment of all chemicals will be a priority before any restriction or prohibition measures are taken. Industry has advocated for the government to include an assessment of socio-economic impact before severely restricting or banning any chemicals. In cases where restrictions are imposed, a relevant mechanism should be provided for the stakeholders to express their appeals. For example, Canadian enterprises have opportunities to communicate with the authority on the priority substances under assessment. In addition, increasing transparency is also a major concern. The public should have the right to access chemical information on the substances to which they are exposed.
The authority is determined to accelerate the legislative process. However, considering there are steps, e.g. public consultation, internal deliberation, inter-ministerial bargaining, State Council’s draft, WTO notification, etc., we expect it to be a long time before final promulgation. MEP Order 7, aka the Measures for the Environmental Management of New Chemical Substances, will be a subordinate measure of the regulation. The current revision of MEP Order 7 will be aligned with the provisions in this regulation. It is hard to say if the revised MEP Order 7 will be delayed. It may be issued before the regulation as long as it is revised within a legal framework and based on principles of the regulation.
The regulation is currently under public consultation. The comments you make will be crucial to future management of chemicals in China. We hope scientists, the industry, NGOs, etc. can have your say on the regulation and play active roles in promoting sound regulations for chemical management in China.