On January 19, 2010, MEP Minister Zhou Shengxian endorsed the No.7 Order of MEP, made public the amended Measures on Environmental Management of New Chemical Substances. This regulation made all-round amendments to the Measures on the Environmental Management of New Chemical Substances (No.17 Order of the former SEPA), which was issued in 2003. The amendment would go into effect as of this day. Relevant person in charge from MEP Department of Pollution Prevention and Control offered some interpretations on it.
What is the role of this regulation? Why the amendments are necessary seven years after the original was enforced?
Measures on Environmental Management of New Chemical Substances is the first regulation targeted at the environmental management of new chemical substances. It provides the basic system that new chemical substances need notice and registration before production and import, demands the registration, labeling, supervision and control of the toxicity and hazards of chemical substances before they are produced and supplied in the market, prevents possible environmental pollution caused by toxic and hazardous chemical substances, protects the environment and people's health at the sources, and safeguards the environmental security.
Since it was enforced seven years ago on October 15, 2003, the original regulation has been playing the role as a "guardian", in terms of intensifying the environmental management on the production and import of new chemical substances, preventing and mitigating the disorderly use of new chemical substances within the territory of China and ensuing environmental pollution, controlling environmental risks caused by new chemical substances, and safeguarding environmental security and people's health. By enforcing the original regulation, the authorities have collected plenty of information on the environmental hazards and exposure risks of new chemical substances, set up a rank of professionals for the testing, review and management of these substances, and set conditions on new chemical substances for their to the market.
However, with the rapid economic development in China, the number of new chemical substances has increased sharply, the chemical management situation at home and abroad has been increasingly serious, the management on new chemical substances has faced greater pressure and challenges, and the environmental security situation has been more prominent. During its enforcement, the original regulation has been gradually proved to be limited in terms of the management requirements and approaches, and the applicants and local environmental protection departments have also complained about the inapplicability of relevant articles. Considering its effectiveness, the original regulation can no longer meet the actual demands for environmental management of new chemical substances because of the following three aspects.
First, the original regulation is not consistent with the international practice in that there are no provisions concerning the varieties of new chemical substances in need of notice even in low quantities, nor simplified registration procedure for scientific research. So it is necessary to amend the original regulation and improve corresponding notice and registration system according to the characteristics of low-quantity production and import as well as scientific researches.
Second, the management of new chemical substances is based on hazard evaluation. However, as the risk evaluation system and risk prevention system are not yet established, it is necessary to gradually learn about the technological characteristics and objective rules of the environmental hazards and exposure of new chemical substances, and on this basis, amend the original regulation and improve its review contents and classified management system.
Third, post-registration supervision has emphasized on the information transmission, without effective supervision on implementation of risk control measures, so it is necessary to amend the original regulation and identify the responsibilities of new chemical substances producers and processers to implement risk control measures, as well as the supervision responsibilities of local environmental protection departments.
Meanwhile, new chemical substances are a growing group of chemical substances, their risk assessment and division of management types are considerably professional and systematic, so it is necessary to make overall plans on the notice, data specification, review and labeling requirement, and post-registration supervision of new chemical substances and have relevant provisions. Therefore, it is imperative that efforts are made to amend the original regulation, in order to improve the new chemical substances notice and registration system and work harder on the effective post-registration supervision on these substances.
New chemical substances notice and registration system was an important system provided by the original regulation, shall the amendment keep it? How does the amendment improve this system, from what aspects?
It has been proved that new chemical substances notice and registration system is an effective and important system to prevent environmental pollution caused by chemicals. The amendment keeps and improves it from five aspects in light of the problems during our practices.
First, the types of notice and registration of new chemical substances are improved. Considering the international practice of the exemption or simplified procedures for low-quantity substances and substances for scientific research and development, the amendment provides three types of notices, the general notice, simplified notice and notice for scientific research. The notice for scientific research is new, and low-quantity notice is included in the simplified notice for substances with annual output or import below one ton. The adjustments to the notice types and the rational risk screening system for new chemical substances are responses to the notice applicants on their long-term concerns in this respect, and encourage the scientific research and development of new chemical substances and the marketing of low-quantity substances.
Second, the review contents of new chemical substances are improved. As the review is the guarantee to know and identify the hazards of new chemical substances, the amendment sets the following stricter requirements for such reviews, that is, from the aspect of hazards, classifying new chemical substances into three types, i.e., the general substances, hazardous substances and key substances; from the aspect of risks, proposing measures for controlling possible risks caused by new chemical substances; and from the aspect of management, providing detailed proposals on whether register the new chemical substances or not. This shows the step-by-step process to know and review the substances.
Third, renewed notice is needed if a new chemical substance exceeds specified quantity or is used for new purposes. Considering that to increase the production and import of new chemical substances or change their uses may result in greater environmental risks and health risks, the amendment provides that those who changes the above two pieces of information shall renew their notices, so as to identify and control possible environmental hazards and risks caused by such changes in quantities or uses.
Fourth, in order to intensify supervision, the amendment has a new provision that basic information on registered new chemical substances shall be made public, that owners of the registration certificates for general notice report after the first activity involving the substance concerned, and that owners of the registration certificates for hazardous notice provide annual reports. A system is provided in the amendment to supervise new chemical substances in local areas to see if the owners of the registration certificates implement risk control measures as required. The amendment is able to realize the whole-process supervision on new chemical substances, prevent and control the environmental risks caused by new chemical substances, and safeguard people's health and environmental security.
Fifth, the amendment provides the mechanisms for revoking and cancelling established registration of new chemical substances. It provides that the environmental protection departments, if they would find in the supervision campaigns hazards or threats imposed by temporary or accumulative environmental pollution, shall order the producers or processors to take immediate actions to remove such hazards or threats and report bottom-up to Ministry of Environmental Protection. Producers or processors shall be punished if damages occur due to failure to implement the risk control measures. Ministry of Environmental Protection shall order owners of the registration certificates to provide information on possible new hazards of the registered substances, and ask for new risk control measures or even revoke the certificates, if damages occur due to poor knowledge about the new chemical substances concerned.
Owners of registration certificates may apply for canceling the registration of the new chemical substances if there are no production or import activities or if these activities are stopped. Ministry of Environmental Protection shall be responsible for making public the cancelations.
What parties are involved in environmental management of new chemical substances?
Many parties are involved in the environmental management of new chemical substances, including general management department (Ministry of Environmental Protection), the accepting and hearing agency (Chemical Registration Center of MEP), reviewing agency (New Chemical Substances Review Committee), testing agency (New Chemical Substance Testing Agency), supervision department (local environmental protection departments), the applicants (new chemical substances producers and importers), and agents (agents for overseas importers to declare new chemical substances in China), and the public who has the right, power and responsibility to disclose, report and accuse any violation of the amended regulation. To adjust and clearly define the responsibilities and obligations of the parties are the key achievements of the amendment.
Why does the amendment provide that the State shall introduce the new chemical substances tracking system?
China is a big producer and user of chemicals. With large quantities, small scales, and low mechanization and automation levels, the chemicals have varied qualities and environmental conditions. Especially, the environmental risks during the processing are prominent. In a long run, the risks in both the production and the processing processes should be considered, in order to intensify environmental security of new chemical substances and take a scaled and environment-friendly development way. Therefore, the amendment has a new and essential provision that the State shall exercise classified risk management on new chemical substances. It clearly provides a tracking system for the risk control and supervision of new chemical substances in addition to the system to know and identify new chemical substances through notice and registration. From knowing the substances to controlling them, from learning about them to taking actions, from approval to supervision and finally to risk control measures, the amendment tries to avoid, remove and mitigate at the sources possible environmental hazards imposed by new chemical substances.
What measures are there to ensure that domestic producers declare and register their new chemical substances? How to ensure the implementation of management measures over the processing of new chemical substances?
In order to ensure that the policies and measures on environmental management of new chemical substances are well implemented, the amendment, building on the recognized influence of environmental impact assessment, provides that environmental protection departments shall consider the registration of new chemical substances as the preconditions for examining and approving environmental impact assessment statements of construction projects on production or processing of such substances. Meanwhile, the amendment also provides that Ministry of Environmental Protection shall organize the canvassing of new chemical substances once every five years. Those who produce, import or process new chemical substances before obtaining the registration certificates shall be punished by environmental protection departments in accordance with the amended regulation. The amendment also provides that owners of registration certificates for general notice shall not transfer the registered new chemical substances to processors unable to take risk control measures, so as to control the transfer of new chemical substances among enterprises. Most importantly, the amendment provides that any entity or individual has the right to disclose, report and accuse of any violations provided in the amendment, achieving the supervision by the whole society. All these measures ensure that the amendment is well implemented.
What links does new chemical substances management involve in accordance with the amendment? How are these links managed?
The amendment involves the links such as the research, production, import and processing of new chemical substances. These links are interrelated and develop gradually. New chemical substances involved in each of these links may cause environmental risks. So, it is necessary to exercise environmental management over new chemical substances in each of these links. It is also an international practice to do so. For new chemical substances for scientific research, as such substances have many varieties and are in low quantities, the amendment considers the international practice and provides a new notice type, that is, the notice for scientific research. For the production and import of new chemical substances, the amendment considers the risk management and provides a new notice type, that is, the low-quantity notice, for new chemical substances with annual output or import volume below one ton. For the processing of new chemical substances, the amendment considers prominent environmental risks posed by new chemical substances during processing, and subject processors to management in addition to the producers and importers, so as to realize the whole-process management of such substances.
The classified supervision on new chemical substances is an important amendment. What are the provisions of the amended regulation in this aspect?
The amendment has a new provision to exercise different tracking and controlling measures on different types of new chemical substances, that is, the general type, hazardous type and key hazardous type subject to environmental management, based on the different management types of the new chemical substances, considering the needs for management during the production, import and processing links, based on the existing capacity of supervision on new chemical substances, and embodying the concept of "mobilizing resources, focusing on priorities, and exercising effective supervision". The requirements for management of the three types of new chemical substances are gradually stricter, and the requirements for key hazardous type subject to environmental management include those for the general type and hazardous type.
The amendment provides that owners of registration certificates for hazardous key new chemical substances subject to environmental management shall implement strict risk control measures, including monitoring or estimating the emissions of new chemical substances into the environment during the production; providing the annual reports and annual plans; transmitting relevant information to processors; implementing risk control measures specified by the registration certificates; reporting the first production or import activity; complying with Regulations on the Safety Management of Hazardous Chemicals or relevant laws, rules and regulations.
The amendment provides that owners of registration certificates for hazardous new chemical substances shall implement special risk control measures, including providing annual reports; transmitting relevant information to processors; implementing risk control measures specified by the registration certificates; reporting the first production or import activity; complying with Regulations on the Safety Management of Hazardous Chemicals or relevant laws, rules and regulations.
The amendment provides that owners of registration certificates for general new chemical substances shall implement the general risk control measures, including transmitting relevant information to processors; implementing risk control measures specified by the registration certificates; and reporting the first production or import activity.
What are the provisions of the amendment on tracking the new chemical substances? What are the new provisions?
The amendment has a chapter on "tracking management" and improves the supervision from three aspects.
First, the amendment provides that owners of registration certificates shall be responsible for implementing the risk control measures specified on the registration certificates, including (1) providing education on the risks of and protection from new chemical substances; (2) intensifying the personal protection of the staff exposed to new chemical substances; (3) providing protection such as enclosure and insulation and setting warning marks; (4) improving the production and use methods of new chemical substances, in order to reduce releases and exposure to the environment; (5) improving the pollution prevention and control processes, in order to reduce the emissions to the environment; (6) developing contingency plans and emergency response measures; (7) other risk control measures.
Second, in order to enable the processors of new chemical substances to shoulder their responsibilities, expand the supervision scope and strengthen supervision, the amendment provides that owners of registration certification for general notices shall describe the hazards of new chemical substances in the Material Safety Data Sheet (MSDS) and send such information on hazards to processors, enabling them to know about the risks of the new chemical substances concerned and implement relevant risk control measures.
Third, the amendment provides that local environmental protection departments shall supervise and inspect on new chemical substances, and inspect relevant enterprises according to the outlines of the inspection regulations and supervision notices, to see whether they have implemented the risk control measures specified in the registration certificates (do as required), whether they have controlled the risks (the effectiveness), and whether the new chemical substances have imposed hazards, and if have, the causes.
What improvements are made by the amendment on legal liabilities?
The amendment has improved the provisions on legal liabilities from the following three aspects, in order to work harder on punishing violations and keep them under effective control, and based on the established administrative punishments for new chemical substances.
First, the amendment strengthens the supervision on new chemical substances after their administrative permits are obtained, and Ministry of Environmental Protection shall impose different punishments according to the circumstances.
For those who conceal relevant information or provide false materials during the notice, Ministry of Environmental Protection shall order them to rectify their behaviors, make public their violations, keep records, and fine penalties between 10,000 yuan and 30,000 yuan. The issued registration certificates shall be revoked.
Ministry of Environmental Protection shall order the enterprises to rectify their behaviors and fine penalties below 10,000 yuan, if they (1) fail to provide as required the updates on the environmental risks of new chemical substances; (2) fail to report as required the statements on the first activity involving the new chemical substances concerned or the flowcharts of the chemical substances; (3) fail to report as required the information on the production or import of new chemical substances in the previous year; (4) fail to provide as required the report on the actual situations over five years.
Second, the amendment improves the legal liability on the supervision on new chemical substances and provides that local environmental protection departments shall impose punishments according to the severity of circumstances.
Local environmental protection departments responsible for supervision shall order the enterprises to rectify their behaviors, fine penalties between 10,000 yuan and 30,000 yuan and report to Ministry of Environmental Protection, which shall make public their violations and keep records, if they (1) refuse or hinder the supervision and inspection by the environmental protection department, or provide false information during the supervision and inspection; (2) produce or import new chemical substances without registration certificates or not in accordance with the registration certificates; (3) process new chemical substances without registration certificates; (4) fail to take risk control measures in accordance with the registration certificates; (5) transfer the registered new chemical substances to processors that fail to take risk control measures.
Local environmental protection departments responsible for supervision shall order the enterprises to rectify their behaviors, and fine penalties between 10,000 yuan and 30,000 yuan, if they (1) fail to transmit as required the risk control information to processors; (2) fail to keep as required the notice materials on new chemical substances and relevant data on the production and import of such substances; (3) use the new chemical substances that are produced or imported for the purpose of scientific research and research and development of processes and products for other purposes or fail to management them as required.
Third, considering the importance of new chemical substances testing and review to their management, the amendment has a new provision on the legal liability of domestic testing agencies and the review committee. The amendment provides that Ministry of Environmental Protection shall withdraw the qualification of the expert in the Review Committee to be elected in the expert tank if he makes false statements or has breach of duties during the review of new chemical substances, and make it public. Ministry of Environmental Protection shall remove it from the list if a domestic testing agency provides false testing data during the testing of new chemical substances to be declared.
Can the amendment be referred to as China's REACH?
REACH (Registration, Evaluation and Authorization of Chemicals, REACH in short) is a regulation enforced by European Union as of June 1, 2007 on the administration of the registration, evaluation and authorization of chemicals. It has the following three distinctive characteristics:
First, there's no distinction between chemical substances and new chemical substances. Any chemical substance with annual output or import volume more than one ton shall require notice and registration as well as submission of testing data. REACH's coverage extends to over 30,000 chemical substances already supplied in the market and used for years.
Second, REACH applies to not only single chemical substances but also such substances in the manufactured goods and articles. So, its targets grow sharply, from industrial consumer goods to civil consumers goods, involving the products in the whole industrial chain.
Third, REACH applies to not only produced or imported chemical substances but also relevant enterprises in the lower stream of the industrial chain, that is, the processors of the chemical substances concerned. It involves the enterprises in the whole industrial chain.
Therefore, the introduction of REACH caused a sensation in global chemicals management.
The amendment is also a regulation on chemicals management and basically consistent with the international practices in terms of management goals, purposes and approaches. However, it still has a large disparity in terms of management scope and targets compared with REACH and cannot be referred to as China's REACH. The disparity can be shown by comparison with the above three characteristics of REACH.
First, the amendment continues with the original management method by distinguishing the chemical substances from new chemical substances and only covers the new chemical substances not included in the List of Existing Chemical Substances in China but not the over 45,000 existing chemical substances in the List.
Second, the amendment shall apply only to articles that intently release new chemical substances and target only at the new chemical substances, not the goods and articles involved.
Third, the amendment shall apply only to the processors of produced or imported new chemical substances and not to the entire enterprises in the whole industrial chain.
(This English version is for your reference only.In case any discrepancy exists between the Chinese and English context, the Chinese version shall prevail.)