at SciVerse ScienceDirect

Environmental Pollution 165 (2012) 174e181

Contents lists available

Environmental Pollution

journal homepage: www.elsevier .com/locate/envpol

Review

Progress of environmental management and risk assessment of industrialchemicals 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 Chinab Lancaster Environment Centre, Lancaster University, UKc The Swire Institute of Marine Science and School of Biological Sciences, The University of Hong Kong, Pokfulam Road, Hong Kong, PR ChinadCollege of Environmental Science and Engineering, Peking University, Beijing, PR ChinaeChina National Environmental Monitoring Centre, Beijing, PR China

a r t i c l e i n f o

Article history:Received 19 August 2011Received in revised form24 November 2011Accepted 3 December 2011

Keywords:Industrial chemicalsNew chemical substancesEnvironmental managementRisk assessmentChina

* Corresponding author.E-mail address: wanghong@craes.org.cn (H. Wang

0269-7491/$ e see front matter � 2011 Elsevier Ltd.doi:10.1016/j.envpol.2011.12.008

a b s t r a c t

With China’s rapid economic growth, chemical-related environmental issues have become increasinglyprominent, and the environmental management of chemicals has garnered increased attention from thegovernment. This review focuses on the current situation and the application of risk assessment inChina’s environmental management of industrial chemicals. The related challenges and research needsof the country are also discussed. The Chinese government promulgated regulations for the import andexport of toxic chemicals in 1994. Regulations for new chemical substances came into force in 2003, andwere revised in 2010 based on the concept of risk management. In order to support the implementationof new regulations, Guidance for Risk Assessment of Chemicals is under development in an attempt toprovide the concepts and techniques of risk assessment. With increasing concern and financial supportfrom Chinese government, China is embarking on the fast track of research and development in envi-ronmental management of industrial chemicals.

� 2011 Elsevier Ltd. All rights reserved.

1. Introduction

The development of chemical industry has been beneficial to theeconomy and the society by meeting the increasing demands inmaterials, but it has also generated increasingly serious health andenvironmental safety problems. Over last four to five decades, somedeveloped countries started to address the safety issues by devel-oping policies and legislations to enable them to promote safechemical management practices (Commission of the EuropeanCommunities, 1967; U.S. Environmental Protection Agency, 2006a).Significant progress has been made in these developed countriesthrough the amendments to those regulations based on supportingdocuments and scientific research evidence, and the adaptationof new concepts and tools related to chemical management. Theregulations and practices in environmental chemical managementare advanced in some of the developed countries, and are graduallyevolving into a prevention-oriented chemical risk managementsystem (EC, 2006).

).

All rights reserved.

The industrialization process in China is now entering its late-middle phase. The annual growth rate of China’s chemical industryfar exceeds that in the United States (US), the European Union (EU)and Japan, becoming the world’s third largest chemical market andimporter (Jian et al., 2007). However, the structure and layoutof China’s chemical industries are still disorganized, and the envi-ronmental problems caused by chemicals are very prominent.With rising frequency of chemical-related accidents, environmentalprotection has become an important issue in China. In addition, withChina’s entrance to the World Trade Organization (WTO), the pres-sure to improve the environmental management of industrialchemicals has been intensified, and the tasks of implementation ofinternational conventions are heavy (Mao and Chang, 2008). Foreignenterprises have been transferring their chemical production lines toChina, further aggravating environmental pollution in the country. Inorder to meet these challenges and gradually conform to interna-tional practices of industrial chemical management, the Chinesegovernment has issued its departmental regulations since 1994 onthe environmental management of toxic chemicals and new chem-ical substances. At present, the country is continuing to push forwardwith additional administrative legislations Table 1.

Table 1Regulations, provisions and Policies of government to industrial chemical environmental management in China.

Regulations, provisions and policies of government Issuer Effective date Reference

RegulationsRegulations on the control over safety of

dangerous chemicalsThe State Council of the People’sRepublic of China

2002 (Revised in 2011) The state council,China, 2011

ProvisionsProvisions on the First Import of Chemicals and

the Import and Export of Toxic ChemicalsNational Environmental ProtectionAgency, GeneralAdministration of Customs & Ministryof Foreign Trade and Economic Cooperation

1994 (Revised in 2007) NEPA GAC & MFTEC,China, 1994

Measures on Environmental Management ofNew Chemical Substances

State Administration of Environmental Protection 2003 (Revised in 2010) MEP China, 2010a

Measures on the Prevention and Control ofEnvironmental Pollution by DiscardedDangerous Chemicals.

State Administration of Environmental Protection 2005 SEPA China, 2005

PoliciesAnnouncement on the List of Toxic Chemicals

Severely Restricted on the Import and Exportin China (Circular No.76)

Ministry of Environmental Protection and GeneralAdministration of Customs of China

2010 MEP and GAC China,2009

Circular on strengthen environmental managementand registration of import & export of toxicchemicals (Circular No.113)

Ministry of Environmental Protection of thePeople’s Republic of China

2010 MEP China, 2009

Circular of MEP on adjustment of environmentalmanagement registration certificate and relevantapplication form for import & export of toxicchemicals (Circular No.15)

Ministry of Environmental Protection of thePeople’s Republic of China

2010 MEP China, 2010b

Announcement on the List of Toxic ChemicalsSeverely Restricted on the Import and Export inChina (Circular No.101)

Ministry of Environmental Protection and GeneralAdministration of Customs of China

2011 MEP and GAC China,2010

Notice on the transition on the registration for NewChemical Substances (Circular No. 123)

Ministry of Environmental Protection of thePeople’s Republic of China

2010 MEP China, 2010c

Notice on the six supportive documents for Measureson the Environmental Management of New ChemicalSubstances, including Guidelines on the Notificationand Registration of New Chemical Substances(Circular No.124)

Ministry of Environmental Protection of thePeople’s Republic of China

2010 MEP China, 2010d

H. Wang et al. / Environmental Pollution 165 (2012) 174e181 175

In recent decades, research on risk assessment techniques hasbeen actively carried out, and there is a general consensus in theinternational community that effective risk management of chem-icals can be achieved by the following steps: 1) Controlling chemicalhazards through risk assessments, 2) Performing comprehensiveanalysis of legal, political, socio-economic and technological factorsby 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 beenestablished, nor have the model tools tailored for chemical riskassessment in China been developed. As the laws and regulations onenvironmental management of chemicals in China are continuouslyprogressing and being implemented, the establishment of a techno-logical system for chemical risk assessment has become an imme-diate necessity.

This review is mainly focused on the evolution and latest trendsin China’s environmental management of industrial chemicals, aswell as the progress in its program for chemical risk assessment. Theneeds for China’s future chemical management are also discussed.

2. Foreign experience in risk management of industrialchemicals

2.1. Overview of foreign environmental management of industrialchemicals

The EU’s legislation addressing industrial chemicals began withthe Dangerous Substances Directive 67/548/EEC (DSD) enacted in1967, which specified the management requirements for the clas-sification, packaging and identification of hazardous chemicals.Subsequently, with a series of successfully issued regulations, the

EU has transformed its management process from simply identi-fying and assessing risks of hazardous chemicals to the currentapproach of risk-based safety assessments on the principles ofprevention (Commission of the European Communities, 1967;Commission of the European Communities, 1992; Commission ofthe European Communities, 1993; Commission of the EuropeanCommunities, 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 establisheda system for the reporting and assessment of new industrialchemicals, at the same time managing the production, import anduse of new industrial chemicals based on the harmfulness ofchemicals. This law was amended in 1986 and again in 2003. The2003 amendment introduced four new features to the Acts:(1) Theconsideration of ecological effects was introduced, (2) The conceptof exposure information was introduced, (3) Measures wereintroduced to deal with chemicals known to be persistent andhighly bioaccumulative, (4) A requirement was placed on manu-factures and importers of chemicals to submit all the informationthey have indicating the hazardous properties of their substances(METI, MHLWandMoE, 2003; Toda, 2007). The US issued the “ToxicSubstances Control Act” (TSCA) in 1976, and the Office of PollutionPrevention and Toxics (OPPT) of the US Environmental ProtectionAgency (USEPA) is responsible for the implementation of this Act.The TSCA specified a series of review processes for new chemicalsbefore they are put on the market and a series of methods to dealwith potential risks in existing chemicals. Currently, this Act isbeing amended to strengthen the assessment and management ofchemicals as related to risks in the workplace, environment andconsumer products (U.S. Environmental Protection Agency, 2006a;Auer and Alter, 2007).

H. Wang et al. / Environmental Pollution 165 (2012) 174e181176

2.2. Application of risk assessment techniques in foreignenvironmental management of industrial chemicals

Under the regulatory framework of the TSCA, the USEPA isresponsible for the risk assessment and management of chemicals.For new chemicals, the TSCA (TSCA x5) requires companies toreport to the USEPA 90 days before the production or import of newchemical substances, and experts should be responsible for iden-tifying and evaluating the possible impacts of exposure and emis-sions of new chemicals on health, the environment and economicdevelopment (U.S. Environmental Protection Agency, 2006b; Auerand Alter, 2007). According to the procedure, enterprises werenot required to provide the test data for the risk assessment of newchemical substances, as the potential dangers of chemicals shouldbe assessed by the EPA itself. For existing chemicals, The TSCA(TSCA x6) requires that restrictive measures be undertakenonly after an assessment showing that the substance “will presentunreasonable risk,” on the assumption that interrupting anongoing industrial process has higher social costs (there are jobs,plant, etc., invested in the material) than forbidding or restrictingconditions under which an intending maker can initiate manufac-ture (U.S. Environmental Protection Agency, 2006c; Auer andAlter, 2007).

In EU, The DSD introduced a classification and labeling sys-tem(C&L) for substances applying three means for hazard commu-nication: standard hazard symbols, supported by risk and safetyphrases. After amended for the 7th time of DSD in 1992, the Directiverequired to perform risk assessment for newly notified chemicalsubstances by the authorities. In 1993 Regulation 793/93/EEC (theExisting Substances Regulation (ESR)) introduced a comprehensiveframework for evaluation and control of existing substances. The ESRscheduled 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 environmentalmanagement of chemicals, the EU issued the first edition of Tech-nical Guidance Document (TGD) on Risk Assessment and the secondeditionwas issued in 2003(EC, 2003). Before the promulgation of theRegistration, Evaluation, Authorization and Restriction of Chemicals(REACH) regulation, assessments of existing substances were carriedout mainly by the member countries (EC, 2006). However, chemicalrisk assessments developed slowly due to the constraints on finance,human and other resources. Since 1993, only 132 HPVCs have gonethrough the risk assessment by priority, and the final reports on only79 chemicals have been completed until 2007. REACH has extendedthe range of risk assessment from new chemicals to all chemicals,and the regulation require that enterprises must carry out riskassessment on any chemical with an output or import amount inexcess of 10 tons. Therefore, the pace of chemical risk assessment hasbeen greatly advanced (Van Leeuwen and Vermeire, 2007).

Except for European and American nations, some internationalcooperation such as Organization for Economic Co-operation andDevelopment (OECD) and World Health Organization (WHO) alsodevelop risk assessment methodologies. The OECD risk assessmentprogram currently focuses on developing and harmonizing forestimating environmental exposures and more specifically on thefollowing four areas: release estimation, exposure modeling, use ofmonitoring data and reporting of exposure information. In order todevelop internationally harmonized generic and technical termsused in chemical hazard/risk assessment, a joint IPCS/OECD projectis developed which will help to facilitate the mutual use andacceptance of the assessment of chemicals between countries,saving resources for both governments and industry. The projectcovers two categories of terms: general terms used in the process ofdetermining hazard and risk, and technical terms used in humanhealth and environmental hazard and risk assessment including

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

3. Environmental management of industrial chemicalsin China

3.1. Administrative authorities on industrial chemical managementin China

In China, the authorities related to industrial chemical manage-ment include national macro level authority, the National Develop-ment and Reform Commission (NDRC), as well as governmentministries and departments/organization authorities: theMinistry ofIndustry and Information Technology (MIIT), the Ministry of PublicSecurity (MPS), the Ministry of Environmental Protection (MEP), theGeneral Administration of Customs (GAC), the State Administrationfor Industry and Commerce (SAIC), the General Administration ofQuality Supervision, Inspection and Quarantine (GAQSIQ), the StateAdministration of Work Safety (SAWS) and other departments.Currently, the MEP is responsible for environmental management ofthe industrial chemicals and acts as the main agency overseeing thesupervision and enforcement of related laws at the national level (Liuet al., 2010). In 2008, State Environmental Protection Administration(SEPA), a sub-ministry of the government, was upgraded toMEP, andthe Office of Environmental Management of Chemicals, whichspecializes in the administration of the development of policies,regulations and technical specifications related to the environmentalmanagement of industrial chemicals, was established in theDepartment of Pollution Prevention and Control of the MEP. Mean-while, it is responsible for the implementation and supervision ofthe management system of chemical pollution prevention andcontrol. This chemical management system includes four specificparts: 1) environmental management of new chemical substances,2) environmental management of import and export of toxicchemicals, 3) environmental management of hazardous wastechemicals and 4) implementation of chemical-related internationalenvironmental conventions.

3.2. Environmental management of import and export of toxicchemicals

China’s environmental management of import and export oftoxic chemicals started back in 1994, following efforts to imple-ment the “London Guidelines for the Exchange of Information onChemicals in International Trade (1989 Amendment)”. In 1994,the National Environmental Protection Agency (NEPA), the GeneralAdministration of Customs (GAC) and the Minister of ForeignTrade and Economic Cooperation (MFTEC) jointly promulgated the“Provisions for Environmental Management on the First Import ofChemicals and the Import and Export of Toxic Chemicals (NEPA,GAC and MFTEC, China, 1994)”. This regulation, which symbolizesthe first step in China’s environmental management of chemicals,describes in detail on the registration categories, informationrequired for the registration, and related fees. The regulationestablishes an environmental examination and approval system forthe import and export of toxic chemicals (Mao, 2007). In theregulation, “toxic chemicals” is defined as “the chemicals harmfulto health and the environment through environmental accumula-tion, bioaccumulation, biotransformation or chemical reaction afterentering the environment, or the chemicals resulting in seriousharm to the human body and potentially risks through contact”.The regulation rules that enterprises have the obligation to applyregistration to environmental authorities when they import orexport toxic chemicals in the “List of Toxic Chemicals Banned orStrictly Restricted in China”. In 1994, SEPA and GAC jointly issued

H. Wang et al. / Environmental Pollution 165 (2012) 174e181 177

the “List of Toxic Chemicals Banned or Strictly Restricted on theImport and Export in China” (Group I, 27 types of toxic chemicals).In order to implement “Stockholm Convention” and “RotterdamConvention”, 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 increasedfrom 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 toxicchemicals have made major progresses over the past 17 years inChina, which include the establishment of the rules for the coun-try’s import and export of toxic chemicals, the control of theunregulated state of toxic chemicals entering China, the significantreduction of the risks posed by these chemicals to public health andenvironment, and the smooth implementation of the “RotterdamConvention” and the “Stockholm Convention” in China. China’senvironmental management of chemicals developed from scratch,yet valuable experience has been gained and a foundation laid forthe future development of the program (Mao, 2007).

Based on the experience in environmental management ofimport and export of toxic chemicals, MEP is preparing a newregulation of environmental management registration for hazardouschemicals of existing chemicals, titled “Measures on EnvironmentalManagement registration of hazardous Chemicals”. The mainpurpose of this new regulation is to identify the key hazardouschemicals of environmental management among existing chemicals,and implement the environmental risk management by environ-mental registration.

3.3. Environmental management of new chemical substances

China’s environmental management of new chemical substancesstarted in 2003. SEPA issued the “Measures on EnvironmentalManagement of New Chemical Substances”, which was the firstofficial regulation related to new chemical substances. The regula-tion defined “new chemical substances” as “the chemical substancesthat have not been produced or imported in the People’s Republic ofChina before notification”. The regulation provided for the basicsystem of notification of new chemical substances, which wouldallow the identification, supervision and control of harmful newchemical substances prior to their production, sale and import, inorder to prevent potential environmental pollution (SEPA China,2003). The implementation of the regulation has played a positiverole in promoting China’s environmental management of newlyproduced and imported chemical substances, and controlling theunregulated use of new chemical substances within the borders ofChina. Meanwhile, under the momentum provided by the regula-tion, China has initially established a professional team for thetesting, evaluation and management of new chemical substances.

Along with China’s rapid economic development, the number ofnewchemical substances is growing quickly, and themanagement ofnew chemical substances is facing increasing pressures and chal-lenges. The development of new foreign technologies and lawshas also highlighted the limitations of China’s current regulationsregarding environmental management goals and tools for evaluatingnew chemical substances. In 2008, the Office of EnvironmentalManagement of Chemicals, MEP, started work on revamping theregulation, and in May 2009 put the revised “Measures on Envi-ronmental Management of New Chemical Substances” (A Draft forComment) 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 messagesreflected in the new regulation are that priority is given to envi-ronmental protection, taking into account scientific and technolog-ical innovations and market rules. It establishes a system to

effectively manage the notification and registration of new chemicalsubstances, classify them according to their risks associated, andmanage, prevent and control these chemicals based on their risks(Zang, 2010; MEP China, 2010a).

Compared with the original regulation, the revised regulationemphasizes five newmajor aspects. (1) It redefines the eligibility ofthe applicant. Only Chinese registered entities can process thenotification of new chemical substances whereas non-Chinesecompanies have to appoint authorized Chinese agents to handletheir notification. (2) It adjusts the categories of notification,allowing the notification of lower quantities of chemical substancesrelated scientific research. (3) It improves the methods for assess-ment to meet the needs of the risk management of new chemicalsubstances, and clearly defining management categories. Therevised “Measures” contains additional content for risk-basedassessment, such as degree of exposure, risk to human healthand the adequacy of environmental risk control measures, whilethe original regulation was mainly concerned with assessing theinherent hazardous properties of new chemical substances.Meanwhile, based on expert assessment, new chemical substancesare now clearly separated into general and hazardous categories.The persistent, bioaccumulative and toxic chemicals in hazardousnew chemical substances list as chemicals of environmentalconcerns. (4) It is required to implement a systemwhich supervises,manages and controls the environmental risk of new chemicalsubstances based on their categories. The revised version requiresthat the registered certificate holders for chemicals in generalcategory pass relevant information to their downstream user. Theregistered certificate holders and their downstream must complywith the risk control measures required by the registration certif-icate of new chemical substances in the general category. Theregistered certificate holders of hazardous chemicals or chemicalsof environmental concerns should further submit annual report tochemical registration centre of MEP. The annual report include theactual amount of production and import, the implementation ofrisk management measures, the actual effect of the new chemicalsubstances to environment and human health. (5) Finally, it clar-ifies the method and time that the new chemicals substance can beincluded in the Inventory of the Existing Chemical Substances(IECSC) and integrates the directives with other managementsystems. The new regulation has adjusted and changed greatly inthe management concept, methods and strategy (Zang, 2010). Themanagement concept has shifted the focus from the hazardassessment of new chemical substances to their risk assessment. Interms of the management methods, the emphasis on the initialnotification stage has changed towards equally emphasizing boththe notification and subsequent supervision processes. Finally, themanagement strategy has changed from imposing a rigidmanagement style to all new chemical substances to a differenti-ated management system according to the hazard and risk level ofthe new chemical substances.

3.4. Environmental management of waste chemicals

In order to effectively control the impact of waste chemicals onthe environment, SEPA issued the “TheMeasures for the Preventionand Control of Environmental Pollution by Discarded DangerousChemicals” in 2005, which specified procedures for implementingsupervision throughout the whole process from production,collection, transportation, storage, processing, use and disposal ofhazardous waste chemicals. The “discarded dangerous chemicals”as mentioned in this “Measures” shall refer to “the dangerouschemicals that are not used but discarded or abandoned by theowners, dangerous chemicals that are washed out of inferiorquality, overdue or lose efficacy, and dangerous chemicals that are

H. Wang et al. / Environmental Pollution 165 (2012) 174e181178

confiscated in the administration activities, according to law bysuch competent authorities as MPS, GAC, GAQSIQ, SAIC, MC, SAWS,MEP, as well as the received dangerous chemicals handed over bythe general public”. The discarded dangerous chemicals belong tothe dangerous wastes, and shall be listed into the State Directory ofDangerousWastes. The law clearly specifies that MEP is responsiblefor unified supervision and management of the prevention andcontrol for environmental pollution from national abandonedhazardous chemicals. Producers of hazardous chemicals areresponsible for recycling, utilizing and disposing the abandoneddangerous chemicals, which they could finish by themselves orentrust to a unit possessing corresponding operating categories andscale and holding a “Hazardous Waste Operating Permit”. Theimporters, sellers and users take the responsibility to entrust toa unit which possesses corresponding operating categories andscale and holds a “Hazardous Waste Operating Permit”, to recycle,utilize and dispose. Producers, importers and sellers are respon-sible for providing information of treatment unit and methods tousers about recycling, utilizing and disposing (SEPA China, 2005).The establishment and implementation of this regulation haveeffectively improved China’s environmental issues related to wastechemicals.

3.5. Implementation of international conventions

China has ratified and carried out active work in the imple-mentation of two important international environmental conven-tions on chemical management, the “Stockholm Convention” and“Rotterdam Convention”. On November 11, 2004, the “StockholmConvention on Persistent Organic Pollutants” officially came intoeffect in China. The Chinese government has always attached greatimportance to its implementation. Approved by the State Council,the National Coordination Group for promoting the implementa-tion of conventions was established in 2005, and led by SEPA, theCoordination Group consists of the National Development andReform Commission and 10 other ministries. In order to implementthe conventions, a focus was placed on understanding the pollutionstatus of POPs in China. A number of investigations were carried outfor this objective, such as, the investigations on the production,distribution, use, import and export, storage, disposal and emissionof pesticide POPs; the investigations on the nature of use andstorage of PCBs in electrical power equipment; and the screens onindustries and key enterprises for their potential to generate dioxinand furan. As a result, the initial status of POPs pollution in Chinahas been identified and the focal area of pollution control proposed.Meanwhile, in the process of preparing the “National Imple-mentation Plan” (NIP), a series of strategic research projectswere conducted, which included planning of pesticide use, PCBsmanagement and disposal, reduction of dioxin emissions, and POPsstorage and waste management and disposal, China’s existinginstitutions, policies, regulations and infrastructure have beenassessed (NIP China, 2007).

The “Rotterdam Convention” came into effect officially in Chinaon June 20, 2005, and during the interim implementation of theconvention, SEPA made great efforts in supporting legislation,institutional construction, personnel training and resource invest-ment. After ratification, the chemicals controlled by the Conventionwere appropriately included in China’s management system ofimport and export of toxic chemicals, and much effort has beenmade in establishing compliance mechanisms and procedures, thedevelopment of domestic supporting regulations, and providingtraining and publicity on the conventions (Mao, 2007).

The Globally Harmonized System of Classification and Labelingof 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 topromote the implementation of GHS in China. MIIT take the lead ofGHS implementation in China. Other departments involvedincluding 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, Chinahas not formulated and implemented an overall plan or scheme ofGHS system. But each department is carrying out relevant workwithin the scope of its official duty. GAQSIQ published 26 nationalstandards called the “Safety rules for classification, precautionarylabeling and precautionary statements of chemicals (GB 20576 wGB 20602)” in 2006. All 26 standards are directly transferred fromUN GHS 1st edition (2003). MIIT systematically investigated theimplementation of China’s GHSWork Planwhich has been finishedin August, 2010. China actively participated in the internationalactivities. The “GHS Stocktaking Workshop for Southeast, East, andCentral Asia”, for instance, took place in Beijing, China from 15 to17 September 2010. The workshop was organized through thecollaboration of the MIIT and United Nations Institute for Trainingand Research (UNITAR). It was the real highlight and boostedthe GHS implementation in China. A Tripartite Policy Dialogue onChemicals Management among the environmental ministers ofChina, Japan and Korea started in 2007. Their work includesmeeting regularly with GHS experts. From 2008 to 2009, China,Japan and Korea performed the classifications for chemicals chosenalready, promoting comparative study and exchanges on thisclassification process, results, law and standards related to GHS (Liet al., 2010). This is a good example coordinated internationalaction. Now the GHS classification for new chemical substancesaccording to national standard (GB 20576 w GB 20602) is requiredby MEP when enterprises apply notification of new chemicalsubstances (Table 2).

4. Progress of chemical risk assessment and riskmanagement in China

China’s chemical risk assessment studies began in the early1990s while the sciences and tools for risk assessment had beendeveloped vigorously outside China. It was a period for China tolearn, introduce and adopt foreign techniques, mainly the generalmethods of risk assessment of toxic organic pollutants, methods ofecological risk assessment and methods of risk assessment ofchemical substances (Cao et al., 1991; Yin, 1995). From the late1990s to the early 21st century, with the rapid development ofenvironmental sciences in China, the aspects of ecological riskassessment of pollutants and risk assessment of pollutants onhuman health began to merge widely in China. And the corre-sponding indicators of regional ecological risk, considering riskresulting from different Chinese regional-scale pollution and otherdisturbance of physical, ecological factors, were established. Therelevant researches included the regional ecological risk assess-ments in the wetland of the Liaohe River Delta, Dongting Lakewatershed, and the ecological risk assessment studies on heavymetals and other pollutants in Lijiang River Scenic Area and otherregions (Lei et al., 2009; Fu et al., 2001; Lu et al., 2003; Yang et al.,2007). With regard to human exposure risk assessment studieswere mainly in the field of the impact of regional particular envi-ronmental pollutants on human health and the routes of humanexposure (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 EnvironmentalManagement of New Chemical Substances” by SEPA attracted theattention of Chinese scientists and great progresses were made inthe development of methodologies in toxicology and ecotoxicologyfor the chemical hazard assessment (SEPA, 2003). The

Table 2Standards and specifications related to chemical environmental management in Chinaa.

Standards and specifications Code Effective date

National standardSafety rules for classification, precautionary labeling and

precautionary statements of chemicalsGB 20576eGB 20599, GB 20601, GB 20602-2006 2008

General rule for classification and hazard communication of chemicals GB 13690-2009 2010General rules for preparation of precautionary label for chemicals GB 15258-2009 2010Classification and hazard pictograms for chemicals-General specification GB/T24774-2009 2010Procedure of chemical safety assessment GB/T24775-2009 2010Grouping and read-across methods of chemicals GB/T24776-2009 2010Safety specification for physico-chemical and dangerous

properties testing laboratory of chemicalsGB/T24777-2009 2010

Guidance of chemical identification GB/T24778-2009 2010Guidance on the validation of QSAR models for chemicals

properties-Health effectsGB/T24779-2009 2010

Guidance on the validation of QSAR models for chemicalspropertiesePhysicochemical properties

GB/T24780-2009 2010

Guidance on the validation of QSAR models for chemicalsproperties-Ecological effects

GB/T24781-2009 2010

Decision method of persistent, bioaccumulative and toxic substances,and very persistent and very bioaccumulative substances

GB/T24782-2009 2010

Technical SpecificationsThe guidelines for the testing of chemicals HJ/T153-2004 2004The guidelines for the hazard evaluation of new chemical substance HJ/T154-2004 2004The guidelines of testing good laboratory practices HJ/T155-2004 2004The guidelines for the generic name of new chemical substance HJ/T420-2008 2008The Guidelines for Hazard Identification of New Chemical Substances In progressThe Guidance for Risk Assessment of Chemical Substances In progress

a References for Table 2 see the Supplementary files.

H. Wang et al. / Environmental Pollution 165 (2012) 174e181 179

establishment of laboratories following Good Laboratory Practices(GLP) and the studies of alternative methods for quantitativestructureeactivity relationship (QSAR) also began. In 2004, SEPAissued “The Guidelines for the Testing of Chemicals” (HJ/T153-2004), “The Guidelines for the Hazard Evaluation of NewChemical Substances” (HJ/T154-2004) and “The Guidelines ofChemical Testing Good Laboratory Practices” (HJ/T155-2004) (SEPAChina,2004a; SEPA China,2004b; SEPA China,2004c). These docu-ments promoted the application of hazard assessments and therelated test methods and laboratory management. “The Guidelinesfor the Testing of Chemicals” was prepared based on the Organi-zation for Economic Co-operation and Development (OECD)Guidelines for the Testing of Chemicals (OECD, 2002). And for thepurpose of protecting the local environment of China, the localspecies of fish (rare minnow) was recommended in the ecotox-icological test methods. “The Guidelines for the Hazard Evaluationof New Chemical Substances” gives the basic method to estimatethe hazard of new chemical substances through hazard classifica-tion. However, at this stage, China’s studies on the risk assessmentof chemicals are still very fragmented and not extensively con-ducted in the academic community, with the exception of theresearch projects supported by the MEP. In 2010, in the revised“Measures for Environmental Management of New ChemicalSubstances”, it is proposed that the risk management of newchemical substances should be based on risk assessment. Seizingsuch a great opportunity, the academic research communityworking on chemicals risk assessment has gradually changed frompurely academic research to applied research for management, andtheir activities greatly attracted the attention of the authorities.

Despite the progress on risk assessment chemicals in China, thebasis of this work is still relatively weak. The technical resourcesare inadequate, such as lack of technical guidance for chemicalassessment; and do not have appropriate prediction models tocarry out chemicals hazard assessment and exposure assessment.For this reason and the need to implement new regulations, theChinese government has begun to attach importance to thedevelopment of risk assessment of chemicals. In its “TwelfthFive-Year Plan” (2011e2015), the Chinese government will increase

financial support to conduct technical assurance researches andestablish a series of technical standards in chemical risk assessmentresearch area.

In addition, although some developed countries and interna-tional organizations all developed risk assessment methodologies,model tools and exposure scenarios, which could provide Chinapretty helpful references. But in China, considering such a bigcountry, the meaningful application of these methods may differ-entiate by its environment condition and the features of theregional ecological zone, the processes of chemical industry, andthe design and operational situations of sewage treatment plants.Therefore in the future, the special research needs of China in riskassessment areas are establishing exposure scenarios to industrialchemicals related to Chinese chemical industry, setting China-featured human exposure parameters and environmental expo-sure parameters based on Chinese population and environment,building suitable models applied to sewage treatment plants ofChina. Such researches will effectively promote the integration ofchemical risk assessment and environmental management.

5. Conclusions

At present, the development of chemical regulations in Chinahas not yet covered the entire life cycle of chemicals (the produc-tion (imports), use, transport and final disposal). So the existingmanagement system should be further improved by introducingmore advanced regulations and policies to meet the needs of themanagement on the whole life cycle of chemicals. Because Chinastarted late compared to some developed countries in riskmanagement of chemicals, there is a big gap in the number ofqualified management professionals and experiences. Therefore,the focus at this stage should be on enhancing applicability andreducing the uncertainty of chemical risk assessment techniques.For this purpose, in hazard assessment area, not only the classicaltesting methods can be used, an appropriate intelligent or inte-grated Testing Strategies (ITS) which can predict the toxicity ofchemicals also should be introduced. At the same time, in exposureassessment area, it should develop some basic exposure models,

H. Wang et al. / Environmental Pollution 165 (2012) 174e181180

and establish exposure parameters based on the specific environ-ment and population in China.

In order to support the implementation of the “Measureson Environmental Management of New Chemical Substances”,currently, the MEP is organizing experts to develop the “Guidancefor Risk Assessment of Chemical Substances”, which is expected tobe issued in 2012. The guidance will be concerned primarily withtwo parts: the basic technological framework and the principles ofmethods for risk assessment of chemical substances in China, i.e.,environmental and health risk assessment. In addition, China is alsoactively seeking international cooperation with United Kingdom,Netherland, US and other countries to enhance the development ofchemical risk assessment. We have reasonable ground to believethat, with increasing attention from the Chinese governmenton environmental management of chemicals, China’s Chemicalsrisk assessment will usher in a rapid development period, anda more comprehensive management system with advanced tech-niques will be established to enhance environmental protection inChina.

Acknowledgements

This work is financially supported by the Ministry of Environ-ment Protection Project of Chemical Pollution Prevention(1441100028) and the National Environmental Protection StandardProject of the Guidelines for Environmental Risk Assessment ofNew Chemical Substances (1678.18).

Appendix. Supplementary material

Supplementary data associated with this article can be found, inthe online version, at doi:10.1016/j.envpol.2011.12.008.

References

Auer, C., Alter, J., 2007. The management of industrial chemicals in the USA. In: VanLeeuwen, C.J., Vermeire, T.G. (Eds.), Risk Assessment of Chemicals, an Intro-duction, second ed. Springer, Dordrecht, Netherland.

Cao, H.F., Shen, Y.W., 1991. Preliminary studies on ecological risk assessment.Environmental Chemistry 10 (3), 26e30 (in Chinese).

Christensen, F.M., Eisenreich, S.J., Rasmussen, K., Sintes, J.R., Sokull-Kluettgen, B.,van de Plassche, E.J., 2011. European experience in chemicals management:integrating science into policy. Environmental Science & Technology 45 (1),80e89.

Commission of the European Communities, 1967. Council Directive 67/548/EEC. Onthe Approximation of the Laws, Regulations and Administrative ProvisionsRelating to the Classification, Packaging and Labeling of Dangerous SubstancesOJ L96.

Commission of the European Communities, 1992. Council Directive 92/32/EEC of 30April 1992 Amending for the 7th Time Directive 67/548/EEC on the Approxi-mation of the Laws, Regulations and Administrative Provisions Relating to theClassification, Packaging and Labelling of Dangerous Substances OJ L154/1.

Commission of the European Communities, 1993. Council Regulation 793/93/EECof 23 March 1993 on the Evaluation and Control of the Risks of ExistingSubstances OJ L084.

Commission of the European Communities, 1994. Commission Regulation 1488/94(EC). Laying Down the Principles for the Assessment of Risks to Man and theEnvironment of Existing Substances in Accordance with Council Regulation793/93 (EC) OJ L161.

Diderich, R., 2007. The OECD chemicals programme. In: Van Leeuwen, C.J.,Vermeire, T.G. (Eds.), Risk Assessment of Chemicals, an Introduction, second ed.Springer, Dordrecht, Netherland.

Duan, X.L., Zhang, W.J., Wang, Z.S., Guo, Y.M., Zhang, Y.S., Zhang, J.L., 2010. Water-related activity and dermal exposure factors of people in typical areas ofnorthern China. Research of Environmental Sciences 23 (1), 55e61 (in Chinese).

EC, European Commission, 2003. Technical Guidance Document in Support ofCommission Directive 93/67/EEC on Risk Assessment for New NotifiedSubstances, Commission Regulation (EC) No. 1488/94 on Risk Assessment forExisting Substances and Directive 98/8/EC of the European Parliament and ofthe Council Concerning the Placing of Biocidal Products on the Market. JointResearch Centre, European Chemicals Bureau, Brussels, Belgium.

EC, European Commission, 2006. Regulation (EC) No. 1907/2006 of the EuropeanParliament and of the Council of 18 December 2006 Concerning the Registra-tion, Evaluation, Authorization and Restriction of Chemicals (REACH),

Establishing a European Chemicals Agency, Amending Directive 1999/45/ECand Repealing Council Regulation (EEC) 793/93 and Commission Regulation(EC) No. 1488/94 Well as Council Directive 76/769/EEC and CommissionDirectives 91/155/EEC, 93/67/EEC, 3/105/EC 2000/21/EC. Off J Eur Union. L 396of 30.12.2006.

Fu, Z.Y., Xu, X.G., Lin, H.P., Wang, X.L., 2001. Regional ecological risk assessment of inthe Liao he River Delta wetlands. Acta Ecologica Sinica 21 (3), 365e373 (inChinese).

Jian, X.D., Zhou, H., Wen, W., Nie, J.L., Shen, Y.W., 2007. Chemical legislation andenvironmental protection. Research of Environment Sciences 20 (1), 123e128(in Chinese).

Lei, B.L., Huang, S.B., Wang, Z.J., 2009. Theories and methods of ecological riskassessment. Progress in Chemistry 21 (2/3), 350e358 (in Chinese).

Li, Y.C., Fan, H.L., Mu, J.X., Ji, G.F., Guo, Z.D., 2010. Discussion on GHS implementationin China. Safety Health and Environment 10 (11), 2e4 (in Chinese).

Liu, C.X., Nie, J.L., Yang, L., Cui, J.Y., 2010. Historical development and current statusof environmental administration of chemicals in China. Modern ChemicalIndustry 30 (5), 7e10 (in Chinese).

Lu, H.W., Zeng, G.M., Xie, G.X., Zhang, S.H.F., Huang, G.H., Jin, X.C., Liu, H.L., 2003.The regional ecological risk assessment of the Dongting Lake watershed. ActaEcologica Sinica 23 (12), 2520e2530 (in Chinese).

Mao, Y., Chang, J.W., 2008. Chemical environmental management and legislation.Environmental Protection 404 (9B), 15e17 (in Chinese).

Mao, Y., 2007. Environmental management of chemicals in China. Journal of Toxi-cology 21 (6), 471e474 (in Chinese).

MEP and GAC China, Ministry of Environmental Protection and General Adminis-tration of Customs the People’s Republic of China, 2009. Announcement on theList of Toxic Chemicals Severely Restricted on the Import and Export in China(Circular No.76) (in Chinese). http://www.customs.gov.cn/publish/portal0/tab399/info207295.htm.

MEP China, Ministry of Environmental Protection the People’s Republic of China,2009. Circular on Strengthen Environmental Management & Registrationof Import & Export of Toxic Chemicals. (Circular No. 113) (in Chinese). http://www.crc-mep.org.cn/news/NEWS_DPW.spx?TitID¼199&T3¼10&LanguageType¼CH&Sub¼1.

MEP China, Ministry of Environmental Protection the People’s Republic of China,2010a. Decree No. 7 of the Ministry of Environmental Protection of the People’sRepublic of China, Measures on Environmental Management of New ChemicalSubstances, 19 January 2010 (in Chinese). http://www.mep.gov.cn/gkml/hbb/bl/201002/t20100201_185231.htm.

MEP China, Ministry of Environmental Protection the People’s Republic of China,2010b. Circular of MEP on Adjustment of Environmental Management Regis-tration Certificate and Relevant Application Form for Import & Export ofToxic Chemicals (Circular No.15) (in Chinese). http://www.crc-mep.org.cn/news/NEWS_DPW.aspx?TitID¼221&T3¼10&LanguageType¼CH&Sub¼1.

MEP and GAC China, Ministry of Environmental Protection and General Adminis-tration of Customs the People’s Republic of China, 2010. Announcement on theList of Toxic Chemicals Severely Restricted on the Import and Export in China(Circular No. 101) (in Chinese). http://www.crc-mep.org.cn/news/NEWS_DPW.aspx?TitID¼267&T3¼10&LanguageType¼CH&Sub¼1.

MEP China, Ministry of Environmental Protection the People’s Republic of China,2010c. Circular of the Ministry of Environmental Protection of the People’sRepublic of China, Notice on the transition on the registration for New ChemicalSubstances (Circular No.123) (in Chinese). http://www.mep.gov.cn/gkml/hbb/bgt/201009/t20100917_194648.htm.

MEP China, Ministry of Environmental Protection the People’s Republic of China,2010d. Circular of the Ministry of Environmental Protection of the People’sRepublic of China, Notice on the six supportive documents for Measureson the Environmental Management of New Chemical Substances, includingGuidelines on the Notification and Registration of New Chemical Sub-stances(Circular No.124) (in Chinese). http://www.mep.gov.cn/gkml/hbb/bgt/201009/t20100921_194878.htm.

METI, MHLW and MoE, 2003. Ministry of Economy, Trade and Industry (METI), theMinistry of Health, Labour and Welfare (MHLW) and the Ministry of theEnvironment (MoE). Outline of the 2003 Partial Amendment to the CSCL. http://www.nite.go.jp/english/.

NEPA, GAC and MFTEC, China, 1994. National Environmental Protection Agency,General Administration of Customs and Ministry of Foreign Trade and EconomicCooperation of the People’s Republic of China, 1994. Provisions on the First Importof Chemicals and the Import and Export of Toxic Chemicals. http://english.mep.gov.cn/Policies_Regulations/regulations/Hazardous_Chemicals/200711/t20071122_113257.htm.

NIP, The People’s Republic of China, 2007. National Implementation Plan for theStockholm Convention of Persistent Organic Pollutants (in Chinese).

OECD, Organization for Economic Co-operation and Development, 2002. Guidelinesfor Testing of Chemicals. OECD, Paris, France.

SEPA China, State Environment Protection Administration the People’s Republic ofChina, 16 September 2003. No, Decree No. 17 of the State EnvironmentalProtection Administration of the People’s Republic of China, Measures forEnvironmental Administration of New Chemical. Substances (in Chinese).http://www.crc-mep.org.cn/news/NEWS_DP.aspx?TitID¼51&T3¼01&LanguageType¼CH&Sub¼2.

SEPA China, State Environment Protection Administration the People’s Republic ofChina, 2004a. The Guidelines for the Testing of Chemicals HJ/T 153-2004 (inChinese).

H. Wang et al. / Environmental Pollution 165 (2012) 174e181 181

SEPA China, State Environment Protection Administration the People’s Republic ofChina, 2004b. The Guidelines for the Hazard Evaluation of New ChemicalSubstances HJ/T 154-2004 (in Chinese).

SEPA China, State Environment Protection Administration the People’s Republic ofChina, 2004c. The Guidelines of Chemical Testing Good Laboratory Practices HJ/T 155-2004 (in Chinese).

SEPA China, State Environment Protection Administration the People’s Republic ofChina, 2005. Waste Prevention and Control of Hazardous Chemicals Pollutingthe Environment Approach (in Chinese). http://www.mep.gov.cn/gkml/zj/jl/200910/t20091022_171831.htm.

The State Council, China, 2011. Regulations on the Control Over Safety of DangerousChemicals (in Chinese). http://www.gov.cn/flfg/2011-03/11/content_1822902.htm.

Toda, E., 2007. The management of industrial chemicals in Japan. In: VanLeeuwen, C.J., Vermeire, T.G. (Eds.), Risk Assessment of Chemicals, An Intro-duction, second ed. Springer, Dordrecht, Netherland.

U.S. Environmental Protection Agency, 2006a. Federal Environmental RegulationsSection E. Toxic Substances Control Act. Last updated on Tuesday, October 10th,2006. U.S. USEPA, Washington, D.C. http://www.epa.gov/dfe/pubs/pwb/tech_rep/fedregs/regsecte.htm.

U.S. Environmental Protection Agency, 2006b. TSCA x5 New Chemicals Program.Last updated on Tuesday, October 3rd, 2006. USEPA, Washington, D.C. http://www.epa.gov/opptintr/newchems/.

U.S. Environmental Protection Agency, 2006c. Exposure Assessment Tools andModels. last updated on Thursday, August 10th, 2006. USEPA, Washington, D.C.http://www.epa.gov/opptintr/exposure/.

Van Leeuwen, C.J., Vermeire, T.G., 2007. Risk Assessment of Chemicals, an Intro-duction, second ed. Springer, Dordrecht, Netherland.

Wang, Z., Liu, S.Q., Chen, X.M., Lin, C.Y., 2008. Estimates of the exposed dermalsurface area of Chinese in view of human health risk assessment. Journal ofSafety and Environment 8 (4), 152e156 (in Chinese).

Wang, Z.S., Duan, X.L., Liu, P., Nie, J., Huang, N., Zhang, J.L., 2009a. Human exposurefactors of Chinese people in environmental health risk assessment. Research ofEnvironmental Sciences 22 (10), 1164e1170 (in Chinese).

Wang, Z.S., Wu, T., Duan, X.L., Wang, S., Zhang, W.J., Wu, X.F., Yu, Y.J., 2009b.Research on Inhalation rate exposure factors of Chinese residents in environ-mental health risk assessment. Research of Environmental Sciences 22 (10),1171e1175 (in Chinese).

Wang, B.B., Duan, X.L., Jiang, Q.J., Huang, N., Qian, Y., Wang, Z.S., Zhang, J.L.,2010. Inhalation exposure factors of residents in a typical region innorthern China. Research of Environmental Sciences 23 (11), 1421 (inChinese).

WHO, World health organization, 2004. IPCS Risk Assessment Terminology. WHO,Geneva.

Yang, Y.D., Su, Z., Bai, L.M., 2007. Ecological risk assessment of the Lijiang RiverScenic area. Academic Forum 192 (1) (in Chinese)106e109.

Yin, H.W., 1995. The program on water environmental risk assessment. ShanghaiEnvironmental Science 14 (11), 11e14 (in Chinese).

Zang, W.C., 2010. How to understand the newly revised “Measures on environ-mental management of new chemical substances”? Environmental Protection6, 43e44 (in Chinese).