Progress of environmental management and risk assessment of industrial chemicals in China

Environmental Pollution 165 (2012) 174e181

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Review

Progress of environmental management and risk assessment of industrial chemicals in China Hong Wang a, *, Zhen-guang Yan a, Hong Li b, Ni-yun Yang a, Kenneth M.Y. Leung c, Yi-zhe Wang a, Ruo-zhen Yu a, Lai Zhang d, Wan-hua Wang a, Cong-ying Jiao e, Zheng-tao Liu a a

State Key Laboratory of Environmental Criteria and Risk Assessment, State Environmental Protection Key Laboratory of Ecological Effect and Risk Assessment of Chemicals, Chinese Research Academy of Environmental Sciences, 8 Dayangfang BeiYuan Road, Chaoyang District, Beijing 100012, PR China Lancaster Environment Centre, Lancaster University, UK c The Swire Institute of Marine Science and School of Biological Sciences, The University of Hong Kong, Pokfulam Road, Hong Kong, PR China d College of Environmental Science and Engineering, Peking University, Beijing, PR China e China National Environmental Monitoring Centre, Beijing, PR China b

a r t i c l e i n f o

a b s t r a c t

Article history: Received 19 August 2011 Received in revised form 24 November 2011 Accepted 3 December 2011

With China’s rapid economic growth, chemical-related environmental issues have become increasingly prominent, and the environmental management of chemicals has garnered increased attention from the government. This review focuses on the current situation and the application of risk assessment in China’s environmental management of industrial chemicals. The related challenges and research needs of the country are also discussed. The Chinese government promulgated regulations for the import and export of toxic chemicals in 1994. Regulations for new chemical substances came into force in 2003, and were revised in 2010 based on the concept of risk management. In order to support the implementation of new regulations, Guidance for Risk Assessment of Chemicals is under development in an attempt to provide the concepts and techniques of risk assessment. With increasing concern and financial support from Chinese government, China is embarking on the fast track of research and development in environmental management of industrial chemicals. Ó 2011 Elsevier Ltd. All rights reserved.

Keywords: Industrial chemicals New chemical substances Environmental management Risk assessment China

1. Introduction The development of chemical industry has been beneficial to the economy and the society by meeting the increasing demands in materials, but it has also generated increasingly serious health and environmental safety problems. Over last four to five decades, some developed countries started to address the safety issues by developing policies and legislations to enable them to promote safe chemical management practices (Commission of the European Communities, 1967; U.S. Environmental Protection Agency, 2006a). Significant progress has been made in these developed countries through the amendments to those regulations based on supporting documents and scientific research evidence, and the adaptation of new concepts and tools related to chemical management. The regulations and practices in environmental chemical management are advanced in some of the developed countries, and are gradually evolving into a prevention-oriented chemical risk management system (EC, 2006). * Corresponding author. E-mail address: [email protected] (H. Wang). 0269-7491/$ e see front matter Ó 2011 Elsevier Ltd. All rights reserved. doi:10.1016/j.envpol.2011.12.008

The industrialization process in China is now entering its latemiddle phase. The annual growth rate of China’s chemical industry far exceeds that in the United States (US), the European Union (EU) and Japan, becoming the world’s third largest chemical market and importer (Jian et al., 2007). However, the structure and layout of China’s chemical industries are still disorganized, and the environmental problems caused by chemicals are very prominent. With rising frequency of chemical-related accidents, environmental protection has become an important issue in China. In addition, with China’s entrance to the World Trade Organization (WTO), the pressure to improve the environmental management of industrial chemicals has been intensified, and the tasks of implementation of international conventions are heavy (Mao and Chang, 2008). Foreign enterprises have been transferring their chemical production lines to China, further aggravating environmental pollution in the country. In order to meet these challenges and gradually conform to international practices of industrial chemical management, the Chinese government has issued its departmental regulations since 1994 on the environmental management of toxic chemicals and new chemical substances. At present, the country is continuing to push forward with additional administrative legislations Table 1.

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Table 1 Regulations, provisions and Policies of government to industrial chemical environmental management in China. Regulations, provisions and policies of government Regulations Regulations on the control over safety of dangerous chemicals Provisions Provisions on the First Import of Chemicals and the Import and Export of Toxic Chemicals

Measures on Environmental Management of New Chemical Substances Measures on the Prevention and Control of Environmental Pollution by Discarded Dangerous Chemicals. Policies Announcement on the List of Toxic Chemicals Severely Restricted on the Import and Export in China (Circular No.76) Circular on strengthen environmental management and registration of import & export of toxic chemicals (Circular No.113) Circular of MEP on adjustment of environmental management registration certificate and relevant application form for import & export of toxic chemicals (Circular No.15) Announcement on the List of Toxic Chemicals Severely Restricted on the Import and Export in China (Circular No.101) Notice on the transition on the registration for New Chemical Substances (Circular No. 123) Notice on the six supportive documents for Measures on the Environmental Management of New Chemical Substances, including Guidelines on the Notification and Registration of New Chemical Substances (Circular No.124)

Issuer

Effective date

Reference

The State Council of the People’s Republic of China

2002 (Revised in 2011)

The state council, China, 2011

National Environmental Protection Agency, General Administration of Customs & Ministry of Foreign Trade and Economic Cooperation State Administration of Environmental Protection

1994 (Revised in 2007)

NEPA GAC & MFTEC, China, 1994

2003 (Revised in 2010)

MEP China, 2010a

State Administration of Environmental Protection

2005

SEPA China, 2005

Ministry of Environmental Protection and General Administration of Customs of China

2010

MEP and GAC China, 2009

Ministry of Environmental Protection of the People’s Republic of China

2010

MEP China, 2009

Ministry of Environmental Protection of the People’s Republic of China

2010

MEP China, 2010b

Ministry of Environmental Protection and General Administration of Customs of China

2011

MEP and GAC China, 2010

Ministry of Environmental Protection of the People’s Republic of China Ministry of Environmental Protection of the People’s Republic of China

2010

MEP China, 2010c

2010

MEP China, 2010d

In recent decades, research on risk assessment techniques has been actively carried out, and there is a general consensus in the international community that effective risk management of chemicals can be achieved by the following steps: 1) Controlling chemical hazards through risk assessments, 2) Performing comprehensive analysis of legal, political, socio-economic and technological factors by authorities, and 3) Adopting control measures. Unfortunately, research on risk assessment techniques started fairly late in China. The national technical guidance for risk assessment has not yet been established, nor have the model tools tailored for chemical risk assessment in China been developed. As the laws and regulations on environmental management of chemicals in China are continuously progressing and being implemented, the establishment of a technological system for chemical risk assessment has become an immediate necessity. This review is mainly focused on the evolution and latest trends in China’s environmental management of industrial chemicals, as well as the progress in its program for chemical risk assessment. The needs for China’s future chemical management are also discussed. 2. Foreign experience in risk management of industrial chemicals 2.1. Overview of foreign environmental management of industrial chemicals The EU’s legislation addressing industrial chemicals began with the Dangerous Substances Directive 67/548/EEC (DSD) enacted in 1967, which specified the management requirements for the classification, packaging and identification of hazardous chemicals. Subsequently, with a series of successfully issued regulations, the

EU has transformed its management process from simply identifying and assessing risks of hazardous chemicals to the current approach of risk-based safety assessments on the principles of prevention (Commission of the European Communities, 1967; Commission of the European Communities, 1992; Commission of the European Communities, 1993; Commission of the European Communities, 1994; EC, 2006; Christensen et al., 2011). In Japan, the industrial chemicals are managed in accordance with the “Chemical Substances Control Law” (CSCL). This law established a system for the reporting and assessment of new industrial chemicals, at the same time managing the production, import and use of new industrial chemicals based on the harmfulness of chemicals. This law was amended in 1986 and again in 2003. The 2003 amendment introduced four new features to the Acts:(1) The consideration of ecological effects was introduced, (2) The concept of exposure information was introduced, (3) Measures were introduced to deal with chemicals known to be persistent and highly bioaccumulative, (4) A requirement was placed on manufactures and importers of chemicals to submit all the information they have indicating the hazardous properties of their substances (METI, MHLW and MoE, 2003; Toda, 2007). The US issued the “Toxic Substances Control Act” (TSCA) in 1976, and the Office of Pollution Prevention and Toxics (OPPT) of the US Environmental Protection Agency (USEPA) is responsible for the implementation of this Act. The TSCA specified a series of review processes for new chemicals before they are put on the market and a series of methods to deal with potential risks in existing chemicals. Currently, this Act is being amended to strengthen the assessment and management of chemicals as related to risks in the workplace, environment and consumer products (U.S. Environmental Protection Agency, 2006a; Auer and Alter, 2007).

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2.2. Application of risk assessment techniques in foreign environmental management of industrial chemicals

scientificetechnical terms used in effects assessment (Diderich, 2007; WHO, 2004).

Under the regulatory framework of the TSCA, the USEPA is responsible for the risk assessment and management of chemicals. For new chemicals, the TSCA (TSCA x5) requires companies to report to the USEPA 90 days before the production or import of new chemical substances, and experts should be responsible for identifying and evaluating the possible impacts of exposure and emissions of new chemicals on health, the environment and economic development (U.S. Environmental Protection Agency, 2006b; Auer and Alter, 2007). According to the procedure, enterprises were not required to provide the test data for the risk assessment of new chemical substances, as the potential dangers of chemicals should be assessed by the EPA itself. For existing chemicals, The TSCA (TSCA x6) requires that restrictive measures be undertaken only after an assessment showing that the substance “will present unreasonable risk,” on the assumption that interrupting an ongoing industrial process has higher social costs (there are jobs, plant, etc., invested in the material) than forbidding or restricting conditions under which an intending maker can initiate manufacture (U.S. Environmental Protection Agency, 2006c; Auer and Alter, 2007). In EU, The DSD introduced a classification and labeling system(C&L) for substances applying three means for hazard communication: standard hazard symbols, supported by risk and safety phrases. After amended for the 7th time of DSD in 1992, the Directive required to perform risk assessment for newly notified chemical substances by the authorities. In 1993 Regulation 793/93/EEC (the Existing Substances Regulation (ESR)) introduced a comprehensive framework for evaluation and control of existing substances. The ESR scheduled the evaluation of existing substances in four phases: data collection, priority setting, risk assessment and risk reduction (Christensen et al., 2011). In 1995, to support the environmental management of chemicals, the EU issued the first edition of Technical Guidance Document (TGD) on Risk Assessment and the second edition was issued in 2003(EC, 2003). Before the promulgation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, assessments of existing substances were carried out mainly by the member countries (EC, 2006). However, chemical risk assessments developed slowly due to the constraints on finance, human and other resources. Since 1993, only 132 HPVCs have gone through the risk assessment by priority, and the final reports on only 79 chemicals have been completed until 2007. REACH has extended the range of risk assessment from new chemicals to all chemicals, and the regulation require that enterprises must carry out risk assessment on any chemical with an output or import amount in excess of 10 tons. Therefore, the pace of chemical risk assessment has been greatly advanced (Van Leeuwen and Vermeire, 2007). Except for European and American nations, some international cooperation such as Organization for Economic Co-operation and Development (OECD) and World Health Organization (WHO) also develop risk assessment methodologies. The OECD risk assessment program currently focuses on developing and harmonizing for estimating environmental exposures and more specifically on the following four areas: release estimation, exposure modeling, use of monitoring data and reporting of exposure information. In order to develop internationally harmonized generic and technical terms used in chemical hazard/risk assessment, a joint IPCS/OECD project is developed which will help to facilitate the mutual use and acceptance of the assessment of chemicals between countries, saving resources for both governments and industry. The project covers two categories of terms: general terms used in the process of determining hazard and risk, and technical terms used in human health and environmental hazard and risk assessment including

3. Environmental management of industrial chemicals in China 3.1. Administrative authorities on industrial chemical management in China In China, the authorities related to industrial chemical management include national macro level authority, the National Development and Reform Commission (NDRC), as well as government ministries and departments/organization authorities: the Ministry of Industry and Information Technology (MIIT), the Ministry of Public Security (MPS), the Ministry of Environmental Protection (MEP), the General Administration of Customs (GAC), the State Administration for Industry and Commerce (SAIC), the General Administration of Quality Supervision, Inspection and Quarantine (GAQSIQ), the State Administration of Work Safety (SAWS) and other departments. Currently, the MEP is responsible for environmental management of the industrial chemicals and acts as the main agency overseeing the supervision and enforcement of related laws at the national level (Liu et al., 2010). In 2008, State Environmental Protection Administration (SEPA), a sub-ministry of the government, was upgraded to MEP, and the Office of Environmental Management of Chemicals, which specializes in the administration of the development of policies, regulations and technical specifications related to the environmental management of industrial chemicals, was established in the Department of Pollution Prevention and Control of the MEP. Meanwhile, it is responsible for the implementation and supervision of the management system of chemical pollution prevention and control. This chemical management system includes four specific parts: 1) environmental management of new chemical substances, 2) environmental management of import and export of toxic chemicals, 3) environmental management of hazardous waste chemicals and 4) implementation of chemical-related international environmental conventions. 3.2. Environmental management of import and export of toxic chemicals China’s environmental management of import and export of toxic chemicals started back in 1994, following efforts to implement the “London Guidelines for the Exchange of Information on Chemicals in International Trade (1989 Amendment)”. In 1994, the National Environmental Protection Agency (NEPA), the General Administration of Customs (GAC) and the Minister of Foreign Trade and Economic Cooperation (MFTEC) jointly promulgated the “Provisions for Environmental Management on the First Import of Chemicals and the Import and Export of Toxic Chemicals (NEPA, GAC and MFTEC, China, 1994)”. This regulation, which symbolizes the first step in China’s environmental management of chemicals, describes in detail on the registration categories, information required for the registration, and related fees. The regulation establishes an environmental examination and approval system for the import and export of toxic chemicals (Mao, 2007). In the regulation, “toxic chemicals” is defined as “the chemicals harmful to health and the environment through environmental accumulation, bioaccumulation, biotransformation or chemical reaction after entering the environment, or the chemicals resulting in serious harm to the human body and potentially risks through contact”. The regulation rules that enterprises have the obligation to apply registration to environmental authorities when they import or export toxic chemicals in the “List of Toxic Chemicals Banned or Strictly Restricted in China”. In 1994, SEPA and GAC jointly issued

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the “List of Toxic Chemicals Banned or Strictly Restricted on the Import and Export in China” (Group I, 27 types of toxic chemicals). In order to implement “Stockholm Convention” and “Rotterdam Convention”, SEPA and GAC jointly issued Circular No. 29 in 2005: adding another 7 types of chemicals in the “List” (Group II). In 2010, the “List” was amended, the number of chemicals types increased from 34 types to 154 types, and in 2011, it increased to 158 types (MEP and GAC China, 2009, 2010). The implementation of the regulation on management of toxic chemicals have made major progresses over the past 17 years in China, which include the establishment of the rules for the country’s import and export of toxic chemicals, the control of the unregulated state of toxic chemicals entering China, the significant reduction of the risks posed by these chemicals to public health and environment, and the smooth implementation of the “Rotterdam Convention” and the “Stockholm Convention” in China. China’s environmental management of chemicals developed from scratch, yet valuable experience has been gained and a foundation laid for the future development of the program (Mao, 2007). Based on the experience in environmental management of import and export of toxic chemicals, MEP is preparing a new regulation of environmental management registration for hazardous chemicals of existing chemicals, titled “Measures on Environmental Management registration of hazardous Chemicals”. The main purpose of this new regulation is to identify the key hazardous chemicals of environmental management among existing chemicals, and implement the environmental risk management by environmental registration. 3.3. Environmental management of new chemical substances China’s environmental management of new chemical substances started in 2003. SEPA issued the “Measures on Environmental Management of New Chemical Substances”, which was the first official regulation related to new chemical substances. The regulation defined “new chemical substances” as “the chemical substances that have not been produced or imported in the People’s Republic of China before notification”. The regulation provided for the basic system of notification of new chemical substances, which would allow the identification, supervision and control of harmful new chemical substances prior to their production, sale and import, in order to prevent potential environmental pollution (SEPA China, 2003). The implementation of the regulation has played a positive role in promoting China’s environmental management of newly produced and imported chemical substances, and controlling the unregulated use of new chemical substances within the borders of China. Meanwhile, under the momentum provided by the regulation, China has initially established a professional team for the testing, evaluation and management of new chemical substances. Along with China’s rapid economic development, the number of new chemical substances is growing quickly, and the management of new chemical substances is facing increasing pressures and challenges. The development of new foreign technologies and laws has also highlighted the limitations of China’s current regulations regarding environmental management goals and tools for evaluating new chemical substances. In 2008, the Office of Environmental Management of Chemicals, MEP, started work on revamping the regulation, and in May 2009 put the revised “Measures on Environmental Management of New Chemical Substances” (A Draft for Comment) for soliciting suggestions from the wider community. After the revision of this draft, the MEP issued a new official version (Decree No.7, 2010 of the MEP) in 2010. The general messages reflected in the new regulation are that priority is given to environmental protection, taking into account scientific and technological innovations and market rules. It establishes a system to

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effectively manage the notification and registration of new chemical substances, classify them according to their risks associated, and manage, prevent and control these chemicals based on their risks (Zang, 2010; MEP China, 2010a). Compared with the original regulation, the revised regulation emphasizes five new major aspects. (1) It redefines the eligibility of the applicant. Only Chinese registered entities can process the notification of new chemical substances whereas non-Chinese companies have to appoint authorized Chinese agents to handle their notification. (2) It adjusts the categories of notification, allowing the notification of lower quantities of chemical substances related scientific research. (3) It improves the methods for assessment to meet the needs of the risk management of new chemical substances, and clearly defining management categories. The revised “Measures” contains additional content for risk-based assessment, such as degree of exposure, risk to human health and the adequacy of environmental risk control measures, while the original regulation was mainly concerned with assessing the inherent hazardous properties of new chemical substances. Meanwhile, based on expert assessment, new chemical substances are now clearly separated into general and hazardous categories. The persistent, bioaccumulative and toxic chemicals in hazardous new chemical substances list as chemicals of environmental concerns. (4) It is required to implement a system which supervises, manages and controls the environmental risk of new chemical substances based on their categories. The revised version requires that the registered certificate holders for chemicals in general category pass relevant information to their downstream user. The registered certificate holders and their downstream must comply with the risk control measures required by the registration certificate of new chemical substances in the general category. The registered certificate holders of hazardous chemicals or chemicals of environmental concerns should further submit annual report to chemical registration centre of MEP. The annual report include the actual amount of production and import, the implementation of risk management measures, the actual effect of the new chemical substances to environment and human health. (5) Finally, it clarifies the method and time that the new chemicals substance can be included in the Inventory of the Existing Chemical Substances (IECSC) and integrates the directives with other management systems. The new regulation has adjusted and changed greatly in the management concept, methods and strategy (Zang, 2010). The management concept has shifted the focus from the hazard assessment of new chemical substances to their risk assessment. In terms of the management methods, the emphasis on the initial notification stage has changed towards equally emphasizing both the notification and subsequent supervision processes. Finally, the management strategy has changed from imposing a rigid management style to all new chemical substances to a differentiated management system according to the hazard and risk level of the new chemical substances. 3.4. Environmental management of waste chemicals In order to effectively control the impact of waste chemicals on the environment, SEPA issued the “The Measures for the Prevention and Control of Environmental Pollution by Discarded Dangerous Chemicals” in 2005, which specified procedures for implementing supervision throughout the whole process from production, collection, transportation, storage, processing, use and disposal of hazardous waste chemicals. The “discarded dangerous chemicals” as mentioned in this “Measures” shall refer to “the dangerous chemicals that are not used but discarded or abandoned by the owners, dangerous chemicals that are washed out of inferior quality, overdue or lose efficacy, and dangerous chemicals that are

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confiscated in the administration activities, according to law by such competent authorities as MPS, GAC, GAQSIQ, SAIC, MC, SAWS, MEP, as well as the received dangerous chemicals handed over by the general public”. The discarded dangerous chemicals belong to the dangerous wastes, and shall be listed into the State Directory of Dangerous Wastes. The law clearly specifies that MEP is responsible for unified supervision and management of the prevention and control for environmental pollution from national abandoned hazardous chemicals. Producers of hazardous chemicals are responsible for recycling, utilizing and disposing the abandoned dangerous chemicals, which they could finish by themselves or entrust to a unit possessing corresponding operating categories and scale and holding a “Hazardous Waste Operating Permit”. The importers, sellers and users take the responsibility to entrust to a unit which possesses corresponding operating categories and scale and holds a “Hazardous Waste Operating Permit”, to recycle, utilize and dispose. Producers, importers and sellers are responsible for providing information of treatment unit and methods to users about recycling, utilizing and disposing (SEPA China, 2005). The establishment and implementation of this regulation have effectively improved China’s environmental issues related to waste chemicals. 3.5. Implementation of international conventions China has ratified and carried out active work in the implementation of two important international environmental conventions on chemical management, the “Stockholm Convention” and “Rotterdam Convention”. On November 11, 2004, the “Stockholm Convention on Persistent Organic Pollutants” officially came into effect in China. The Chinese government has always attached great importance to its implementation. Approved by the State Council, the National Coordination Group for promoting the implementation of conventions was established in 2005, and led by SEPA, the Coordination Group consists of the National Development and Reform Commission and 10 other ministries. In order to implement the conventions, a focus was placed on understanding the pollution status of POPs in China. A number of investigations were carried out for this objective, such as, the investigations on the production, distribution, use, import and export, storage, disposal and emission of pesticide POPs; the investigations on the nature of use and storage of PCBs in electrical power equipment; and the screens on industries and key enterprises for their potential to generate dioxin and furan. As a result, the initial status of POPs pollution in China has been identified and the focal area of pollution control proposed. Meanwhile, in the process of preparing the “National Implementation Plan” (NIP), a series of strategic research projects were conducted, which included planning of pesticide use, PCBs management and disposal, reduction of dioxin emissions, and POPs storage and waste management and disposal, China’s existing institutions, policies, regulations and infrastructure have been assessed (NIP China, 2007). The “Rotterdam Convention” came into effect officially in China on June 20, 2005, and during the interim implementation of the convention, SEPA made great efforts in supporting legislation, institutional construction, personnel training and resource investment. After ratification, the chemicals controlled by the Convention were appropriately included in China’s management system of import and export of toxic chemicals, and much effort has been made in establishing compliance mechanisms and procedures, the development of domestic supporting regulations, and providing training and publicity on the conventions (Mao, 2007). The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) has been implementing throughout the world. China also actively joins the implementation of GHS and relative

departments have modified laws, regulations and standards to promote the implementation of GHS in China. MIIT take the lead of GHS implementation in China. Other departments involved including MEP, SAWS, GAQSIQ, MPC, the Ministry of Public Health (MPH), the Ministry of Transport (MT), the Ministry of Railways (MR), the Ministry of Agriculture (MA), SAIC, etc. At present, China has not formulated and implemented an overall plan or scheme of GHS system. But each department is carrying out relevant work within the scope of its official duty. GAQSIQ published 26 national standards called the “Safety rules for classification, precautionary labeling and precautionary statements of chemicals (GB 20576 w GB 20602)” in 2006. All 26 standards are directly transferred from UN GHS 1st edition (2003). MIIT systematically investigated the implementation of China’s GHS Work Plan which has been finished in August, 2010. China actively participated in the international activities. The “GHS Stocktaking Workshop for Southeast, East, and Central Asia”, for instance, took place in Beijing, China from 15 to 17 September 2010. The workshop was organized through the collaboration of the MIIT and United Nations Institute for Training and Research (UNITAR). It was the real highlight and boosted the GHS implementation in China. A Tripartite Policy Dialogue on Chemicals Management among the environmental ministers of China, Japan and Korea started in 2007. Their work includes meeting regularly with GHS experts. From 2008 to 2009, China, Japan and Korea performed the classifications for chemicals chosen already, promoting comparative study and exchanges on this classification process, results, law and standards related to GHS (Li et al., 2010). This is a good example coordinated international action. Now the GHS classification for new chemical substances according to national standard (GB 20576 w GB 20602) is required by MEP when enterprises apply notification of new chemical substances (Table 2). 4. Progress of chemical risk assessment and risk management in China China’s chemical risk assessment studies began in the early 1990s while the sciences and tools for risk assessment had been developed vigorously outside China. It was a period for China to learn, introduce and adopt foreign techniques, mainly the general methods of risk assessment of toxic organic pollutants, methods of ecological risk assessment and methods of risk assessment of chemical substances (Cao et al., 1991; Yin, 1995). From the late 1990s to the early 21st century, with the rapid development of environmental sciences in China, the aspects of ecological risk assessment of pollutants and risk assessment of pollutants on human health began to merge widely in China. And the corresponding indicators of regional ecological risk, considering risk resulting from different Chinese regional-scale pollution and other disturbance of physical, ecological factors, were established. The relevant researches included the regional ecological risk assessments in the wetland of the Liaohe River Delta, Dongting Lake watershed, and the ecological risk assessment studies on heavy metals and other pollutants in Lijiang River Scenic Area and other regions (Lei et al., 2009; Fu et al., 2001; Lu et al., 2003; Yang et al., 2007). With regard to human exposure risk assessment studies were mainly in the field of the impact of regional particular environmental pollutants on human health and the routes of human exposure (e.g., skin, respiration and drinking water) (Wang et al., 2008, 2009a, 2009b, 2010; Duan et al., 2010). In 2003, the issuing of the “Measures on Environmental Management of New Chemical Substances” by SEPA attracted the attention of Chinese scientists and great progresses were made in the development of methodologies in toxicology and ecotoxicology for the chemical hazard assessment (SEPA, 2003). The

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Table 2 Standards and specifications related to chemical environmental management in Chinaa. Standards and specifications National standard Safety rules for classification, precautionary labeling and precautionary statements of chemicals General rule for classification and hazard communication of chemicals General rules for preparation of precautionary label for chemicals Classification and hazard pictograms for chemicals-General specification Procedure of chemical safety assessment Grouping and read-across methods of chemicals Safety specification for physico-chemical and dangerous properties testing laboratory of chemicals Guidance of chemical identification Guidance on the validation of QSAR models for chemicals properties-Health effects Guidance on the validation of QSAR models for chemicals propertiesePhysicochemical properties Guidance on the validation of QSAR models for chemicals properties-Ecological effects Decision method of persistent, bioaccumulative and toxic substances, and very persistent and very bioaccumulative substances Technical Specifications The guidelines for the testing of chemicals The guidelines for the hazard evaluation of new chemical substance The guidelines of testing good laboratory practices The guidelines for the generic name of new chemical substance The Guidelines for Hazard Identification of New Chemical Substances The Guidance for Risk Assessment of Chemical Substances a

Code

Effective date

GB 20576eGB 20599, GB 20601, GB 20602-2006

2008

GB 13690-2009 GB 15258-2009 GB/T24774-2009 GB/T24775-2009 GB/T24776-2009 GB/T24777-2009

2010 2010 2010 2010 2010 2010

GB/T24778-2009 GB/T24779-2009

2010 2010

GB/T24780-2009

2010

GB/T24781-2009

2010

GB/T24782-2009

2010

HJ/T153-2004 HJ/T154-2004 HJ/T155-2004 HJ/T420-2008

2004 2004 2004 2008 In progress In progress

References for Table 2 see the Supplementary files.

establishment of laboratories following Good Laboratory Practices (GLP) and the studies of alternative methods for quantitative structureeactivity relationship (QSAR) also began. In 2004, SEPA issued “The Guidelines for the Testing of Chemicals” (HJ/T1532004), “The Guidelines for the Hazard Evaluation of New Chemical Substances” (HJ/T154-2004) and “The Guidelines of Chemical Testing Good Laboratory Practices” (HJ/T155-2004) (SEPA China,2004a; SEPA China,2004b; SEPA China,2004c). These documents promoted the application of hazard assessments and the related test methods and laboratory management. “The Guidelines for the Testing of Chemicals” was prepared based on the Organization for Economic Co-operation and Development (OECD) Guidelines for the Testing of Chemicals (OECD, 2002). And for the purpose of protecting the local environment of China, the local species of fish (rare minnow) was recommended in the ecotoxicological test methods. “The Guidelines for the Hazard Evaluation of New Chemical Substances” gives the basic method to estimate the hazard of new chemical substances through hazard classification. However, at this stage, China’s studies on the risk assessment of chemicals are still very fragmented and not extensively conducted in the academic community, with the exception of the research projects supported by the MEP. In 2010, in the revised “Measures for Environmental Management of New Chemical Substances”, it is proposed that the risk management of new chemical substances should be based on risk assessment. Seizing such a great opportunity, the academic research community working on chemicals risk assessment has gradually changed from purely academic research to applied research for management, and their activities greatly attracted the attention of the authorities. Despite the progress on risk assessment chemicals in China, the basis of this work is still relatively weak. The technical resources are inadequate, such as lack of technical guidance for chemical assessment; and do not have appropriate prediction models to carry out chemicals hazard assessment and exposure assessment. For this reason and the need to implement new regulations, the Chinese government has begun to attach importance to the development of risk assessment of chemicals. In its “Twelfth Five-Year Plan” (2011e2015), the Chinese government will increase

financial support to conduct technical assurance researches and establish a series of technical standards in chemical risk assessment research area. In addition, although some developed countries and international organizations all developed risk assessment methodologies, model tools and exposure scenarios, which could provide China pretty helpful references. But in China, considering such a big country, the meaningful application of these methods may differentiate by its environment condition and the features of the regional ecological zone, the processes of chemical industry, and the design and operational situations of sewage treatment plants. Therefore in the future, the special research needs of China in risk assessment areas are establishing exposure scenarios to industrial chemicals related to Chinese chemical industry, setting Chinafeatured human exposure parameters and environmental exposure parameters based on Chinese population and environment, building suitable models applied to sewage treatment plants of China. Such researches will effectively promote the integration of chemical risk assessment and environmental management. 5. Conclusions At present, the development of chemical regulations in China has not yet covered the entire life cycle of chemicals (the production (imports), use, transport and final disposal). So the existing management system should be further improved by introducing more advanced regulations and policies to meet the needs of the management on the whole life cycle of chemicals. Because China started late compared to some developed countries in risk management of chemicals, there is a big gap in the number of qualified management professionals and experiences. Therefore, the focus at this stage should be on enhancing applicability and reducing the uncertainty of chemical risk assessment techniques. For this purpose, in hazard assessment area, not only the classical testing methods can be used, an appropriate intelligent or integrated Testing Strategies (ITS) which can predict the toxicity of chemicals also should be introduced. At the same time, in exposure assessment area, it should develop some basic exposure models,

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