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Thoughts on the Regulations on Environmental Risk Assessment and Control of Chemical Substances (Draft for Comment)
2019-02-20 17:42:10 点击数:
                                                                                                                                 By Haitao SU
 
On January 8, 2019, the Ministry of Ecology and Environment of China publicly solicited opinions on the “Regulations on Environmental Risk Assessment and Control of Chemical Substances (Draft for Comment)” (hereinafter referred to as the “Regulations”), and this freshly issued policy is a new milestone in China chemical management. In this article, I would like to share some thoughts, which are based on my professional experience and the discussions with my peers, with the industry. 
Q1: Why is the "Regulations" a new milestone in China's chemical management? 
The core contents of the Regulations are the risk assessment and risk management of existing chemical substances, as well as the new chemical access system. For the management of existing chemical substances, China has not yet established a legal system for environmental risk assessment and control. The introduction of the "Regulations" can be viewed as a breakthrough from scratch. And for the management of new chemical substances, from old Decree No. 17 to the current Order No. 7, we have been studying and exploring a management approach that is suitable for China's national conditions and responsible for the environment and the people. 
In the Regulations, the management of new chemical substances focuses on simplifying the approval process, emphasizing corporate self-responsibility and social responsibility, strengthening post-regulatory efforts, and defining relevant legal responsibilities. By drawing on international experience and combining China's national conditions, the promulgation of the "Regulations" has raised the management of chemical substances to the level of legislation, which clearly demonstrates China authorities’ determination on strengthening chemical substances management. 
Q2: What is the structure and main idea of the Regulations? 
The "Regulations" consists of six chapters with forty-five articles altogether. The first chapter is "General Principles" and the last chapter is "the Supplementary Provisions"; the second and third chapters focus on the management of existing chemical substances, while the fourth chapter on the management of new chemical substances; Chapter five defines Relevant legal liabilities. 
The core idea of the "Regulations" is: to identify high-risk chemical substances scientifically based on risk assessment; to take prevention and control methods at hazard source; to differentiate and manage “new” and “old” chemical substances and substances with different risks; to enhance public's knowledge, in order to better control and reduce environmental risks of chemical substances.  
Q3: Can the Regulations be equated with EU REACH?
The Order No. 7 (Decree of the Ministry of Environmental Protection) has long since been called CHINA REACH in the industry. I personally can't agree with it. REACH is the EU's management of all chemicals entering the EU market, while Order No. 7 only manages new chemical substances. The obvious difference can be told from the management object, let alone other detailed aspects. The new Regulations, like REACH, cover the management of existing and new chemical substances. Can it be called CHINA REACH this time? I believe that there is still a significant differentia between the two: different management approach on existing chemicals.  
EU REACH implements a registration system for both existing and new chemical substances, while the China “Regulations” does not require businesses to register the existing chemicals. Instead, enterprises are asked to provide basic information so that the environmental protection authorities can organize environmental risk screening, investigate and monitor the occurrence of chemical substances, and identify high-risk chemical substances through risk assessment. The "Regulations" are quite in line with China's current conditions, and do not impose excessive burden on enterprises. It requires government departments to lead the screening of high-risk chemical substances for comprehensive management, which is fundamentally different from REACH management idea. 
Q4: How is the existing chemical substance managed in the Regulations? 
The second and third chapters of the Regulations deal with the management of existing chemical substances, firstly on the chemical environmental risk assessment, followed by the environmental risk management. 
The environmental risk assessment part includes activities such as basic information reports on chemical substances, environmental risk screening, investigation and monitoring on the occurrence of chemical substances, and risk assessment, among which the basic information report is currently one of the hot topics discussed in the industry. The “Regulations” stipulate that enterprises that produce, process or use chemical substances need to submit basic information reports. From the perspective of source management, production enterprises and import enterprises together will suffice, since if processing and using of the chemicals are also included, the total activity amount of each individual substance will be double-counted. This is one of the reasons that cause the industry concern. The second reason is that this basic information report also requires companies to report on the chemical name, detailed usage and quantity of production, processing or importing chemicals in the previous year. Although the details remain unclear, how to balance the concerns of the enterprises and the needs of management data collection spurred intense industry discussion. Will it be more implementable if the inventory of existing chemicals is involved? Will a systematic classification of uses be more convenient for later statistics and management after data collection? We will have to wait and see. 
Chemical environmental risk control section proposes the establishment of three lists: List of Substances of Very High Concern (SVHC), List of Strictly Restricting Substances, and List of Prohibited Substances. An on-line environmental information disclosure platform for SVHC will be established. And MEE will cooperate and jointly manage with the Customs on the implementation of import and export license of strictly restricted substances. On December 14, 2018, MEE released the "List of Toxic and Harmful Air Pollutants (First Batch) (Draft for Comment)", which involved 11 chemicals. Water and Soil pollutants may also have their respective management list in the near future.
Q5: What changes have been made to the management of new chemical substances?
The content of the management on new chemical substances in Chapter four is more detailed and clear than the management of existing chemical substances. China has been managing new chemical substances since 2004 and has accumulated a lot of experience along the way. Compared with the current Order No. 7, there are several major changes in the management on new chemical substances in the Regulations: 
1. Changes in registration type: the Scientific Research Record Notification in the Order No. 7 will be cancelled; the current Simplified Registration (both special circumstances and basic circumstance) will be changed to the notification system. After the notifer has obtained the Acceptance receipt, the relevant activities of the newly notified chemical substances can be carried out. On the one hand, the application process is simplified; on the other hand, the change from the approval system to the autonomous notification system means that the applicants shall assume more social responsibilities.
2. It is made very clear in the Regulations that a new chemical substance that meets the criteria of being a PBT substance or equivalent hazards will not be registered and will be included in the List of Prohibited Substances.
3. The contents on the Registration Certificate will have some changes: the holder of the registration certificate is the applicant itself, the name of the local representative will no longer be listed; the environmental risk management measures will be more detailed, including one or more of the following items:
(1) Limit on the production or import volume of new chemical substances;
(3) Limits on the emission or emission concentration of new chemical substances;
(3) Stipulations on the usage;
(4) Risk management and control measures proposed by the Expert Review Committee.
4. There will be Registration Fee for new chemical substances registration.
Q6: When will new chemical substances be listed as existing chemical substances?
The "Regulations" indicates that new chemical substances that have been registered for five years shall be publicly announced by MEE and listed in the "Inventory of Chemical Substances in
China" (hereinafter referred to as the "Inventory"). However, the listing time in the current Order No. 7 is five years from the date of the first production or import activity, not from the date of registration; moreover, the registrants of hazardous and key hazardous substances shall also submit an Actual Activity Report for retrospective evaluation before listing really happens. 
This revision indeed simplifies the process. However, from the perspective of the applicant, this revision will lead to a shortened period of confidentiality or market barrier, which is also highly concerned by many enterprises. 
Q7: What does the clear definition of legal liability in the Regulations mean?
The fifth chapter clearly defines the legal liability and the punishment on the relevant staff, experts, laboratories and enterprises.  The current Order No. 7 is a departmental regulation, whose illegal cost is very low (the upper limit being 30,000 RMB) and the deterrent is far from enough. After the promulgation of the "Regulations", Order No. 7 will have a superior law. It is strongly believed that with the improvement of corporate social responsibility and the strengthening of supervision and regulation, more and more domestic chemical companies will take the initiative in chemical compliance. 

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