Introduction
Chemicals: their Hazards and Risks
1. There are about 7 million chemical substances produced in the world with more than 70,000 in common use. Some 1,000 new substances are introduced each year. There are 45,000 substances listed in the 'Inventory of Existing Chemical Substances in China’ and about one hundred new substances are added into the inventory every year. Chemicals are an indispensable means of production of consumer goods in the modern world, and are used in medicine, pesticides, fertilizer, plastic, textile fibre, electronic chemical, domestic decoration material, soap and laundry powder, cosmetic and food additive applications. However, many chemicals harm human beings and the environment in different degrees. Misuse, abuse, chemical accidents or improper disposal during production, storage, distribution, transportation, usage and waste disposal may bring negative influence to human health and environment.
2. It took a long time for the environmental and health hazards of chemicals to be well understood. Along with the development of human civilization, many chemicals have been are produced and widely used, which has led to local and global environmental and health hazards and occupational safety issues, such as persistent, bioaccumulative and toxic chemicals（PBTs）, endocrine disrupting chemicals（EDCs）, accidental leakage of hazardous chemicals, transboundary movements of hazardous wastes and their disposal and ozone depletion substances（ODS）, et al.. Hazards of unintentionally produced toxic and hazardous chemicals such as Dioxin also emerged. According to the WHO, global cancer rates have increased so fast since the last century that today, 4-5 million people die from cancer which accounts for about 12-25% of the total number of deaths; and chemical factors account for 80% of the total factors for cancer.
Demands for Environmental Management of Chemicals in China
3. In China, as traditional pollution problems are gradually addressed, the demand for environmentally-sound management of chemicals is gradually increasing.
Change of Governance Conceptions
4. The Chinese government has confirmed its determination to realize three transformations during 2006:（a）to change from emphasizing economic growth while ignoring environmental protection to stressing both environmental protection and economic growth;（b）to change from environmental protection lagging behind economic development to environmental protection progressing simultaneously with economic growth, to try to pay back the old debts without accumulating new debts and change the situation that treatment follows pollution and destruction accompanies treatment;（c）to change from depending mainly on administrative measures for environmental protection to comprehensively taking legal, economic, technical and necessary administrative measures to solve environmental problems. The ‘Decision of the State Council on Implementing the Scientific Development Concept for Strengthening Environmental Protection’, part five, which concerns establishing and improving a long-term effective mechanism for environmental protection, points out that necessary environmental regulations and standard systems on chemical pollution should be improved.
Adjust the Industrial Structure to Meet the Demands of Economic Development and Sustainable Development
5. According to the ‘Outline of the Eleventh Five-Year Plan for National Economic and Social Development’, China will speed up the change of the economic growth model. Resource conservation should be considered as a basic national policy of China, to promote recycling and reuse, protect the environment, promote a resource-conserving and environment-friendly society, take a practical new road to industrialization, clean and safe development, and finally realize sustainable development. Chapters like ‘adjustment of industrial distribution’ et al. specify a development plan relevant to optimise the structure of the chemical industry, including basic chemical feedstock, and fine chemicals while eliminating pollution-intensive chemical enterprises.
Demand of International Environmental Protection
6. Since 1970, developed countries have established legal systems related to chemical management and they have also urged relevant UN bodies to establish and implement several global conventions and concepts successively, such as: Convention concerning Safety in the Use of Chemicals at Work, Prevention of Major Industrial Accidents Convention, Basel Convention on Control of Transboundary Movements of Hazardous Wastes and Their Disposal, Rotterdam Convention on International Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, The Stockholm Convention on Persistent Organic Pollutants, The Globally Harmonized System of Classification and Labeling of chemicals and the Strategic Approach to International Chemicals Management, et al.. While developed countries and regions have established comparable improved chemical management systems, there is a big gap in chemical management between a majority of developing countries including China and the developed countries. Therefore Environmentally Sound Management of Chemicals （SMC hereafter）has become a requirement for economic development and social progress for developing countries, especially for China, wlhich is a large producer and consumer of chemicals.
Demand of International Trade
7. China has become one of the world’s largest exporting countries. Foreign trade is an important driver for continuing increases in the national GDP. China faces a challenge meeting WTO requirements. However, in recent years, China has encountered stricter technical barriers to its export trade （hereafter TBT）from developed countries, and especially ‘green barriers’ to trade. According to an investigation by the Ministry of Commerce, in 2002, the year China joined the WTO, exports in the six sectors including the agricultural product sector were frustrated severely by TBT constraints. About 71% of export enterprises and 39% of export products encountered the foreign TBT limit, which caused a loss of about 17 billion USD, equivalent to 5.2% of the total exports. Until now, nearly 90% of food and agricultural products were blocked resulting in a 9 billion USD loss. Laws and standards related to chemicals and their marketing in China still do not protect human health, and the environment sufficiently.
Existing Problems in Environmentally Sound Management of Chemicals
8. SMC is weak in China. Relevant laws and regulations include: the ‘Law on the Prevention and Control of Environmental Pollution by Solid Wastes’; ‘Regulations on Safe Management of Hazardous Chemicals’; and ‘Regulations on Pesticide Management’. Involved departments include environmental protection, commerce, safe production and customs. However, the environmental management of chemicals in China cannot fundamentally safeguard the environment and human health. Major problems include: （a）lack of a clearly-defined national policy and/or strategy; （b）the legal system （laws and regulations）not being well established; （c）inadequate capacity of administrative organs, law enforcement and supervision capacity; （d）lack of public participation; （e）a technical support system for management not being well established, and insufficient integrated management measures.
Fields of Environmental Management of Chemicals
9. The management of chemicals includes （1）environmental management of chemicals; （2）management of protection of consumers of chemicals and （3）management of worker safety and health. ‘Environmentally sound management of chemicals’ is quoted from chapter 19 subject 11 of Agenda 21, programmatic document for the international environmental management of chemicals, where six programme areas are proposed: （1）expanding and accelerating international assessment of chemical risks; （2）harmonization of classification and labeling of chemicals; （3）information exchange on toxic chemicals and chemical risks; （4）establishment of risk reduction programmes; （5）strengthening of national capabilities and capacities for management of chemicals; （6）prevention of illegal international traffic in toxic and dangerous products, moreover the International Forum on Chemical Safety （IFCS）and the Inter-Organization Programme for the Sound Management of Chemicals （IOMC）are proposed to be created here. The aim is to develop management of chemicals from an environmental viewpoint in order to protect the environment and human health.
Task Source and Objectives of this Research
10. The China Council for International Cooperation on Environment and Development （CCICED）established a multilateral consultation mechanism, which offers a platform for China to widely absorb international experiences in environmental pollution prevention policy, precautionary mechanisms, pollution treatment and environmental management. In a deployment meeting of CCICED’s work, Vice Premier Zeng Peiyan pointed out: “special attention should be paid to environmental pollution caused by chemicals, there are lots of pressing problems that need to be resolved in such areas as well as equipping environmental protection installations for chemical industrial enterprises, strengthening the safety management on storage and transportation of chemicals, prevention and timely control of the accidental leakage of hazardous chemicals; then, hope to arrange some specific studies and provide some effective intellectual support to the government”.
11. To improve the regulatory system and chemical management capacity in China, it is desirable to analyze and evaluate the environmental management system of chemicals in China, learn advanced international experiences about that, and bring forward major policy suggestions for the SMC in China.
Drafting of the Report
12. This research is supported by the Environmental Policy Programme of the Deutsche Gesellschaft für Technische Zusammenarbeit （GTZ）GmbH on behalf of the Sino-German Cooperation of the German Federal Ministry for Economic Cooperation and Development and the State Environmental Protection Administration （SEPA）. The report is accomplished by four domestic experts, Jianxin HU, Zhengyu LI, Jianguo LIU, Yan MAO and three international experts, Ulrike Kowalski, Silke Schmidt and David van Hoogstraten. In development of the report, stakeholders, at home and abroad, were consulted many times. Through symposium and consultation, opinions were listened to and taken into account from experts from related domestic agencies, local governments, and related sectors, enterprises, non-governmental organizations, and revisions were made accordingly.
Chemical Industry & the Main Environmental Issues
General Situation of Chemical Industry in China
13. Since the 1990s, the annual rate of production value of the Chinese chemical industry has increased more than 30% in China. According to the national standard classification of the national economy （GB/T4754-2002）, the Chinese chemical industry includes 10 sectors: chemical ore mining, basic chemical raw materials, chemical fertilizers, chemical pesticides, paints, inks and dyes, synthetic materials, specialized chemical products, rubber products and chemical manufacturing equipment. The basic chemical raw materials and synthetic materials sectors account for 20% of the total production value of chemical industry, the fine chemicals, rubber products and chemical fertilizer sectors each account for 10-15% respectively. These five sectors account for about 85% of the total. In 2005, the total production value of the chemical industry in China was 2.1 trillion RMB （or 257.7 billion USD）which is 8.4% of the total GDP. The total value of import and export of chemicals in China was 133.5 billion USD in 2005. The value of exports is 48.1 billion USD, and the value of imports is 85.5 billion USD. There are about 4.1 million employees and more than 21,000 enterprises （with annual sales value of more than 5 million RMB）in the chemical industry, while 90% are small and medium sized enterprises.
14. At present, there are more than 20 kinds of chemicals with the world’s leading production and consumption in China. Production capacity of sulfuric acid and ammonia and other basic chemical raw materials, chemical fertilizers and dyes, and synthetic fiber ranks the first in the world, production of chemical pesticides and painting output ranks second and third in the world respectively, production capacity of the main type of synthetic resin and synthetic rubber ranks the fourth in the world, consumption of pesticides, synthetic rubber and other chemicals ranks first in the world[1][2]. According to the OECD, the annual increase in the rate of global production value of the chemical industry will be 2.6% to 3.5%. Considering China’s economy and chemical industry development trends, future production and consumption of chemicals in China will keep rapidly increasing, and will have a significant impact on the global production and consumption of chemicals.
15. Chemical enterprises in China are mainly located in Eastern China （Shanghai, Jiangsu and Zhejiang, Anhui, Fujian, Jiangxi and Shandong Provinces）and the central region （Henan, Hubei, Hunan, Guangdong, Guangxi and Hainan Provinces）, which accounts for 71% of the total chemical enterprises. Under the dual pressure of the need for environmental protection and industrial structure adjustment, chemical enterprises in China began to transform and restructure to collectivization and large-scale production in recent years, and have established many chemical industrial parks for centralized chemicals production. At present, more than 60 chemical industry parks have been approved by government above the provincial level.
16. The widest applications of chemicals include medicine, pesticide, fertilizer, plastic, textile fibre, electronics, domestic decoration material, soap and laundry powder, cosmetics, and food additives.
Environmental Issues of Chemicals in China
17. As a developing country, the technology of chemical industry and risk management of chemicals in China is still far behind the developed countries. Many harmful chemicals banned or severely-restricted by the international community or that have begun to be phased out in developed countries are still produced and consumed in China.
18. Scientific monitoring shows that the concentration of DDT and other chlorinated pesticides which have been banned internationally for nearly 30 years, is above the international standard of risk assessment in the Pearl River Delta region sediment. Concentration of POPs pollutants like DDT and BHC in tea and aquatic product like fish and shellfish in some regions are relatively high, concentrations of DDT and BHC in breast milk are still significantly higher than in developed countries. Due to the wide use of synthetic detergent nonylphenol is in the Beijing-Hangzhou Grand Canal and water in Jiangnan water, and is detected in tap water in Shanghai. Recent monitoring shows high concentrations of toxic organic pollutants in the lower reaches of the Yangtze. The detection rate of PCBs, HCB and lindane approaches 100%. In Chongqing waters of Three Gorges, there are 178 persistent organic pollutants detected and 18 of these substances are on the ‘black list’ of preferred controlled pollutant in water by EPA.
19. Many environmental incidents take place involving toxic chemicals. According to a SEPA report, the total number of environmental incidents was 1,406 in 2005, including: 693 water pollution incidents, 538 air pollution incidents, 19 ocean pollution incidents, 48 solid waste pollution incidents, and 108 other pollution incidents. Direct economic loss from pollution is about 105.15 million RMB （excluding the Songhua River incident）. The polluted area reached 46.91 million m², including 43.1891 million m² of crop area, 3.455300 million m² of water ponds, and 266,800 thousand m² of nature reserve. In the November 13, 2005 explosion incident at Jilin Petrochemical Company of Petro China, six people died, 60 people were injured, and more than 10,000 people escaped in an emergency evacuation. The explosion caused about 100 MT benzene substances to be released into the Songhua River, seriously polluting its lower and middle reaches. Millions of coastal residents have been affected.
20. According to national statistics reports, from 2002 to 2004 there are 435 non-explosive hazardous chemical incidents occurred in Beijing, Chengdu, Chongqing, Guangzhou, Harbin, Nanjing, Qingdao, Shanghai, Shenyang, Wuhan, Xi'an and Zhengzhou, 189 people died, 390 people were injured and 962 people were poisoned in the incidents. Among the 435 hazardous chemical incidents, 70 happened in production enterprises near urban areas, resulting in heavy poisoning and evacuation. E.g. the chlorine tank explosion on April 16, 2004 in the Chongqing Tianyuan chemical plant led to an evacuation of 150,000 residents near the Jiangbei District.
21. Existing information indicates that these problems are getting worse. The whole society is facing increasing environmental and health risks from chemicals.
Safety and Environmental Management of Chemicals in China
Legislation on Safety and Environmental Management of Chemicals
22. China has promulgated a series of laws and regulations on safe management of hazardous chemicals, pesticides, pharmaceuticals, animal medicine, as listed in Annex 1, tables 1 and 2. Relevant ministries of the State Council also establish corresponding departmental rules and regulations for implementation. China has also promulgated a series of safety standards on classification of hazardous chemicals, storage, transportation, packaging and labeling, environmental standards for the control of chemical pollutant discharges and hazardous waste disposal, and occupational health standards.
23. China has established supervisory agencies for safe and environmental management of hazardous chemicals within the central government and at the local level. AT the State Council level, they include State Environmental Protection Administration （SEPA）, State Administration of Work Safety （SAWS）, Ministry of Health （MoH）, State Food and Drug Administration （SFDA）, Ministry of Agriculture （MoA）, General Administration of Quality Supervision, Inspection and Quarantine （AQSIQ）, Ministry of Communication, Ministry of Railways and General Administration of Aviation, and the Ministry of Public Security （MPS）. A description of their tasks is given in Annex 2.
24. Under the authority of relevant national laws, regulations and the State Council authorization, the National Development and Reform Committee （NDRC）is authorized to establish environmentally-friendly industrial policies, including cleaner production and recycling and reuse, and restriction or elimination of outdated production techniques, equipment, and products, as well as production licenses for some pesticides; the Ministry of Foreign Affairs （MoFA）has authority to engage in international negotiations on chemicals convention implementation; the General Administration of Customs （GAC）is authorized to inspect and audit the import/export of hazardous chemicals; the Ministry of Commerce, the Ministry of Science and Technology （MoST）and other ministries have authority over the import and export of chemicals and research and development of pollution prevention technologies.
25. SEPA has set up administration of solid waste and toxic chemicals specializing in registration of hazardous wastes, and review work on registration of import and export of toxic chemicals and reporting and registration of new chemical substances. The Bureau of environmental supervision is responsible for guidance and cooperation in the settlement of major environmental problems of local, departments, trans-regional and inter-basin; establishing emergency response plans in response to serious environmental pollution accident and environmental damage. The Division of international cooperation is responsible for external negotiations of environmental conventions, coordinating with MoFA and managing implementation of environmental conventions related to chemicals.
26. Relevant ministries of the State Council have set up special agencies for management and technical support, such as the SEPA chemical registration center and solid waste management center. Under the direct guidance of respective administrations, they are responsible for specific functions such as registration of new chemical substances, environmental management and registration of import/export of toxic chemicals; safe registration of hazardous chemicals and pesticides, etc.
27. There are local supervision and management institutions of hazardous chemicals and environmental management in China. Environmental protection bureau, production safety bureau, the health bureau, agriculture bureau, quality and technical bureau in the provinces （autonomous regions and municipalities）and municipal districts and the county government are in charge of supervision and management of hazardous chemicals and pesticides for safety and environment protection in these areas.
28. The relationship between local government departments and relevant superior departments is generally one of operational guidance. E.g. local environmental protection bureaus in the people's governments above the county level are under the guidance of government of the same level, and also accept operational guidance from higher levels of environmental protection departments. There are local environment monitoring stations and environmental science research institutes in the local governments’ environmental protection agency.
29. China has adopted ‘Rules on Management of Hazardous Chemicals’ and established a multi-sectoral system framework for national management of hazardous chemicals, which contains the full process of production, management, storage, transport, usage and waste disposal of hazardous chemicals. To coordinate supervision and safe management of hazardous chemicals by relevant ministries of the State Council, and approved by the State Council, an inter-ministerial meeting system for safe production supervision of hazardous chemical was set up in June 2007. It includes the following 16 ministries and committees of the State Council: SAWS, NDRC, MPS, MoST, Ministry of Finance （MoF）, Ministry of Construction, Ministry of Railways, Ministry of Communication, State Administration for Industry and Commerce, AQSIQ, SEPA, CAAC, All China Federation of Trade Unions, Ministry of Labor and Social Security, MoH, SASAC, and the Information Centre Legislative Affairs Office of the State Council.
30. China also has established the National Coordination Group for Implementation of the Stockholm Convention （NCG）, consisting of 13 ministries and agencies: SEPA, MoFA, NDRC, MoST, MoF, the Ministry of Construction, Ministry of Commerce, MoA, MoH, the General Administration of Customs, and the AQSIQ, et al..
Major Environmental and Safety Management Regulations and their Implementation
31. The NPC Standing Committee and the State Council issue laws and regulations on management of drugs, cosmetics, food and food additives, feed and feed additives, pesticides and other specialty chemicals, a system of safety evaluation and production permit on special chemicals as set out in the Annex 1 Table 3. Supervision and management of other industrial chemicals used as industrial raw materials and raw materials of chemicals for daily use are primarily in accordance with the ‘Regulation on Management of Hazardous Chemicals’ issued by the State Council.
32. In May 1994, China began implementing environmental management of the import and export of toxic chemicals. SEPA placed the hazardous chemicals controlled by the ‘Prior Informed Consent procedure for certain hazardous chemicals and pesticides under the Rotterdam convention’ onto the list of toxic chemicals banned or severely restricted in China, implements registration of environmental management for import and export, and implements the PIC procedure. In June 2005, SEPA together with GAC, issued the ‘List of Toxic Chemicals Banned or Severely Restricted in China （the second group）’, and added seven highly toxic chemicals onto the management list and within the scope of import/export list of environmental management, which came into effect on July 10th, 2005. In December 2005, SEPA together with the GAC issued the ‘List of Toxic Chemicals Severely Restricted on Import and Export in China’, which came into effect on January 1st, 2006, and the number of restricted chemicals on the list increased from 34 to 188.
33. To prevent and control the hazard and risk to human health and the environment by industrial chemicals at the source, SEPA issued and implemented ‘Measures for Environmental Management of New Chemical Substances （Order No.17）’ on October 15th, 2003, and then began to implement the declaration and registration of new chemical substances before import or production. Based on the identification and assessment of health impacts and environmental hazard of new substances, it approves the registration and permits the production and import of new chemical substances which meet the risk evaluation standards, while taking measures to ban or restrict production and use of chemicals with high risk to human health and the environment.
34. Since the registration system of new chemical substances was put into practice in 2003, SEPA has established and updated the ‘inventory of existing chemical substances in China[3]. After the fifth supplement and update, identification information exists for 45,000 chemical substances.
35. To identify and evaluate hazards and environmental risks of new chemical substances, SEPA set up an accreditation committee of experts on new chemical substances consisting of technical and management experts on chemistry, toxicology and ecological toxicology, environmental science and safety science. The committee engages in physical, health, environmental hazard and environmental risk assessment for each new chemical substance based on ‘the guidelines for the hazard evaluation of new chemical substances （HJ/T154-2004）’, and makes recommendations on scientific management.
36. In the environmental management of construction projects for chemical production, China has made great progress in the strict environmental impact assessment （EIA）management of industrial construction projects and in strengthening capacity for management of responses to environmental emergencies. In the past years, the implementation rate of the EIA report （questionnaire）for large and medium-sized chemical construction projects remained at over 98%. Since 2005, SEPA has required that the project sites meet national industrial policy, plan and environmental requirements, and choose environmentally friendly production technology and product programs. New projects are required to reduce pollutants in the region. Expansion and reconstruction projects are required to implement ‘carrying the old with the new technologies’ and generally achieve ‘increased production without new pollution’ or ‘increasing production and reducing pollution’.
37. After the explosion in China's Jilin chemical plant in November 2005 causing serious pollution in Songhua River, SEPA issued the ‘notice on strengthening the management of environmental impact assessment, environmental risk prevention [UNCED （2005）152]’, requiring the strengthening of EIA and planning of chemical and petrifaction industries, preventing environmental risks from the source of decision-making, strict review of the projects, strengthening the environmental risk assessment management of construction projects and comprehensive investigation, supplementing and improving the preventive measures for environmental risks.
38. Based on the ‘national emergency plan for the environment’ issued by the State Council in 2005, the Environmental Monitoring Bureau of SEPA issued relevant emergency response procedures, and guided the provincial environmental protection departments to formulate and improve the local environmental contingency plans and emergency response systems.
39. In accordance with ‘Regulation on Safe Management of Hazardous Chemicals’ issued by the State Council, the SAWS, since 2002, carried out the system of licensing for the safe production, for operation production and safety registration for enterprises that produce, store and use hazardous chemicals. It also established an emergency planning system for hazardous chemical facilities listed as major hazard sources, and established a national emergency rescue command center for safe production of hazardous chemicals and a local emergency rescue center.
Management List of Chemicals and Management Focus
40. Of the 45,000 chemical substances that China has produced or imported from 1992 to 2005 that are listed in the SEPA ‘Inventory of the existing chemical substances in China’, there are, according to the State Council ‘Regulation on safe management of hazardous chemicals’, 3,700 hazardous chemicals on the ‘List of hazardous chemicals （2002 edition）’ issued by SAWS.
41. By September 2006, there were more than 1,000 banned or severely restricted chemicals on the control list of safe and environmental management issued by relevant ministries of the State Council （see Annex 1 Table 4）.
42. According to the ‘Regulation on safe management of hazardous chemicals’ by the State Council, the objects of management of hazardous chemicals in China are chemicals in the ‘Name list of dangerous goods’, acutely toxic chemicals, production and storage facilities of major hazardous sources of chemicals. Priority chemicals to be managed are chemicals with explosive, flammable, oxidizing, corrosive and acute toxic characteristics.
43. The environmental management of chemicals by SEPA is mainly focused on the supervision and management of toxic chemicals with acute toxicity. Management by SEPA is mainly focused on life cycle emissions of chemical pollutants, end of pipeline control and disposal of toxic chemicals released into the environment and the environmental management on import/export of toxic chemicals.
Technical Support for Management of Chemicals
44. Under the jurisdiction of the national and local environmental protection, public health, agriculture, quality inspection, industrial, technological and educational departments, there are thousands of national and local research institutes for research of environmental monitoring of chemical pollutants, monitoring of pesticide residues, research and development of pesticide alternatives, standards establishment, pollution prevention and control, prevention of diseases and poisoning, information management, et al. They provide the government departments with technical support.
45. Environmental monitoring in China is a four-grade monitoring and management system consisting of general station, provincial, the city and county stations. The general and provincial environmental monitoring centers （stations）are equipped with large-sized advanced analytical instruments, better specialized technical personnel and capabilities for detection and analysis of chemical pollutants.
46. China has established a number of laboratories testing physicochemical, toxicological and ecotoxicological properties of chemicals. Most of these laboratories belong to relevant research institutions of ministries or large enterprises.
47. There are 8 ecotoxicological testing laboratories under the SEPA system, including the key laboratory of ecological effect and risk assessment of chemicals, Chinese Research Academy of Environmental Sciences, et al., which may engage in assessment and test of environmental hazards.
48. There are 25 health toxicology testing laboratories under the MoH and the SFDA, including the occupational health and poison control stations of Chinese Disease Control and Prevention Center, etc., which may engage in testing research of acute toxicity, chronic toxicity, carcinogenicity, mutagenicity, reproductive toxicity, safety pharmacology and toxicokinetics of drugs, cosmetics and other chemicals.
49. There is a pesticide testing laboratory system consisting of hundreds of pesticide laboratories under the MoA, including the centers for agrochemical, biological and environmental technology, institute for the control of agrochemicals, MoA, which may engage in testing and evaluation projects of pesticide residues, pesticides toxicology, environmental toxicity, pesticide efficacy and in biological testing.
50. There is a group of testing and evaluation laboratories engaging in industrial chemicals, cosmetics, electronics chemicals and food under the AQSIQ system, including the institute of industrial product inspection, the Chinese Academy of Inspection and Quarantine, and there are 10 testing laboratories for hazardous characteristics of chemical combustion, explosion and other physico-chemical properties being built currently.
51. As for the certification and supervision of chemical testing laboratories （Good laboratory practice, GLP）, these laboratories are supervised by different related ministries respectively. According to the ‘OECD chemical testing criteria’ and the GLP, SEPA promulgated ‘the guidelines for the testing of chemicals - test method for chemicals （HJ/T153-2004）’ and the ‘guidelines for chemical testing good laboratory practices （HJ/T155- 2004）’ in 2004, and began to develop management of ecotoxicology laboratory and inspection of qualified laboratory GLP.
52. SFDA issued ‘information on promoting the implementation of quality management criterion for non-clinical drug research in November 2006, the notice requirements since January 1, 2007, for Chemical Raw Pharmaceuticals and its preparation, biological products, traditional Chinese medicine injection that are not in the domestic market should have their non-clinical safety research and evaluation in GLP certified laboratories. Otherwise, their applications for drug registration will not be accepted. At the same time, a list of 22 GLP certified pharmaceutical laboratories is also issued.
53. MoA issued the ‘good laboratory practice for toxicological safety evaluation of pesticide’ in 2003, and implemented in the ‘measures on evaluation management of good pesticide laboratory’ in November, 2006, and began to carry out GLP inspection and evaluation of pesticide testing laboratories.
54. The MoH promulgated the ‘criterion of management of identification of toxicity of chemicals’ in 2001, raised regulatory requirements to the identification of toxicity of chemicals and identification agencies, but didn’t implement GLP criterion management to the safety evaluation laboratories of cosmetics and toxicological testing laboratories under its supervision.
55. The National Certification and Accreditation Regulatory Committee promulgated a ‘General requirements for the competence of calibration and testing laboratories’ and ‘criteria for laboratory accreditation evaluation’ in 2006. In accordance with international standards of ‘General requirements for the competence of calibration and testing laboratories （ISO/IEC17025: 2005）’ and national standard ‘General requirements for the competence of calibration and testing laboratories （GB/T15481: 2000）’, they begin to develop evaluation and certification of laboratories based on their capacity and qualifications
56. China is not a member of OECD. It does not fully adopt the internationally accepted ‘OECD guidelines for testing of chemicals’ and ‘principles of good laboratory practice’ on criteria for evaluation of new chemical substances, qualified laboratories assessment, certification and review, and supervision and management of Labs. Whether the testing methods, management program and management requirements in the majority of chemical testing laboratories accord with international management criteria must still be determined. Evaluation and certification management of chemical testing laboratories in China is in the beginning stages, laboratory testing ability and management cannot meet the domestic demand for safe and environmental sound management of chemicals. Therefore, chemical test results are not recognized and accepted by other countries.
Regulatory systems and good practices on SMC in developed countries and international policies
57. From 1970s to 1980s, as a result of the significant impact of and general concern over environmental issues caused by certain synthetic chemicals, ie., DDT and PCBs, Chemical legislation was widely established in developed countries. As a result of such chemical legislation, regulatory systems on environmentally sound management of chemicals were set up step by step, with risk assessment and risk management as the basic idea, whose core content is to carry out notification, evaluation and authorization of new chemicals newly produced, imported and entering into market, and to carry on hazard testing, risk assessment and risk management of existing chemicals in the market according to special priority principle and order. Meanwhile, the developed countries have established a number of basic systems on pollution control, accident prevention and emergency response during the life cycle of hazardous chemicals, to control the environmental and health risks of hazardous chemicals. Whereas the processes of information, collection, evaluation and risk assessment of hazards and risks of existing chemicals are slow, since the beginning of 21 century, to accelerate the information collection, evaluation and risk management processes of hazard and risk information of existing chemicals, some developed countries have further reformed the current system on risk assessment and risk management for existing chemicals, pursued chemicals testing, evaluation and priority chemicals risk management system by taking the “precautionary principle” and extending risk responsibility of chemicals’ manufacturers as main content, such as the EU REACH legislation. In addition, a number of effective new chemicals environmental management approaches were explored and implemented, to accelerate the process of existing chemicals hazard risk assessment, and to continually identify, screen, and eliminate the PBT chemicals and other hazardous chemicals with high environmental risks.
Basic Systems of Chemical Environmental Management
New Chemical Substance Notification System
58. New chemical substance notification system is a basic system for environmental management of chemicals. New chemicals manufacturers or importers notify the basic property and hazard information of new chemicals to the state administrative departments, and the competent departments carry on assessment and authorization of chemicals hazards and environmental and health risks and take management measures according to the actual condition before placing on the market or import of new chemicals, such as notification, prohibition or restriction etc. From 1970s to 1980s, most developed countries have established new chemicals notification systems by legislative acts specifically for chemicals, e.g. “Chemical Control Act” of Japan in 1973, Toxic Substances Control Act （TSCA）of the United States in 1976 and 79/831/EEC Directive for dangerous substances classification, packaging and labeling （the sixth amendment of EU 67/548/EEC）in 1979.
59. In the EU the volume for notifications of new chemicals marketed or imported was divided into three grades and the higher the marketed / imported volume of new chemicals, the stricter and more detailed the data required. EU requires declarers to provide various heath and environmental hazard data consistent with the OECD’s Good Laboratory Practice （GLP）requirement and the testing guidelines. The OECD developed a unified minimum data requirement for new chemicals notification generally followed by EU and other OECD countries, the so-called “Minimum Data Set”, and its contents are basically consistent with the “Base Set” shown in Annex 3.
60. TSCA can be divided into 4 parts: （1）general information, including types, molecular formulas, composition and purity of new chemicals, preparation process, production/import volume, use and the occupational safety notes of new chemicals, etc.; （2）human exposure and environmental release information, including operating rules, occupational exposure assessment and protection measures, environmental exposure assessment and control technology information; （3）appendix safety and testing information, including material safety data sheet （MSDS）, existing health and environmental toxicity data, physical and chemical nature, etc. test data （optional）; （4）information that is optional to provide, including related information of pollution prevention. The extensive health and environmental hazard information of chemicals evaluated and reviewed under the U.S. new chemicals notification system is shown in Annex 4. Unlike the EU, data in connection with new chemicals notification under TSCA, the U.S. statute, is based on existing data and usually additional testing is not mandated.
61. For new chemicals proven to have unreasonable health and environmental risks after the evaluation, new chemicals notification system prescribes to take risk management measures, such as the prohibition or restriction of their production, use, import and export.
Risk Assessment and Risk Management System on Existing Chemical Substances
62. “Existing chemical substances” are the chemical substances which were produced, sold and used in the market during certain time in the past （EU）or from certain time to now （USA）. In 1993, EU promulgated “Regulation EEC （No）793/93 on the evaluation and control of the environmental risks of existing substances”, requiring the manufacturers and importers of chemicals for information notification who had produced or imported in quantities in excess of 10t/y by stages before 1998 and prescribing the manufacturers and importers of HPV chemicals which are produced or imported in quantities in excess of 1,000t/y to submit a few sets of chemicals risk assessment data including the approach to environment and fate, eco-toxicity, acute toxicity, sub-acute toxicity and so on. EU established an inventory of existing chemicals named “EINECS[4]: European Inventory of Existing Commercial Substances”, and started 1993 an existing chemicals priority risk assessment and risk management plan EU countries, in order to gradually assess and control the environmental and health risks of existing chemicals.
63. In TSCA, EPA may request the chemical producer or importer to provide hazard testing information of a chemical substance, and take regulatory measures in the form of prohibiting the manufacture of the substance, or of strictly regulating its use, or both, when the chemical substance presents an unreasonable risk of harm to health or the environment or the amount of the chemicals could cause significant human or environmental exposure but the data for basic risk evaluation was lacking and toxicity testing was necessary. TSCA also authorized the establishment of a testing advisory committee for EPA to provide priority chemical substance list for testing, evaluation and risk management of existing chemicals.
64. Given the large number of existing chemicals and the complexity of chemicals risk assessment, priority risk management has become the basic policy for the risk assessment and management of existing chemicals. This has led to institutional or systematic hazard testing for the high production volume chemicals （HPV, production volume> 1,000 tons / year）which generally means high exposure probability, and risk management measures being taken according to specific standards for certain high-risk or priority chemicals, e.g., prohibit or restrict the production or use of certain “priority toxic chemicals”, such as PBT, CMR or vPvB chemicals. Priority risk management is also reflected in the new EU-REACH system that requires manufacturers and importers of substances in quantities of 10 tonnes or more per year to assess the risks arising from the “identified” uses of their substances.
65. Risk assessment and risk management of existing hazardous chemicals, risk information notification, necessary testing and risk assessment, and risk management principles for priority chemicals, can enable governmental managers to obtain the basic information on hazards and risks of existing chemicals. Based on that, risk management actions including, prohibition or restriction of the production and use of certain priority chemicals with high environmental and health risk can be reasonably conducted by the governmental authorities, and the environmental and health risk of existing chemicals may be gradually reduced. Therefore, risk assessment and risk management system for existing chemicals has becomes another basic tool of chemicals environmental management, EU’s REACH legislation can be considered as its reinforcement. REACH aims at companies doing their risk assessments themselves. In addition, it provides mechanisms for the authorities to introduce European wide risk management measures for substances with unreasonable risks by adopting restrictions and through the authorization system.
EU-REACH System （2006/2007）
66. In December 2006 the EU adopted its “REACH-Regulation” which entered into force on 1st June 2007. The Regulation replaces a number of regulations on environmental management of major chemicals that had been established since the 1970s. The purpose of the REACH-Regulation is “to ensure a high level of protection of human health and the environment, …, as well as the free circulation of substances on the …[EU] market while enhancing competitiveness and innovation.” Thus, it combines economic growth and the protection of human health and the environment. Also the precautionary principle has been taken into account when the REACH Regulation was developed and its requirements were fixed, and the principle now “underpins” the provisions of the Regulation.
67. REACH inter alia aims at resolving the problem of lack of information on existing chemical hazards and risks, and at accelerating the existing chemicals risk management process. REACH reverses the “burden of proof” for existing substances from the authorities to the enterprises so that it is up to them to perform the risk assessment for the “identified” uses of the substances they manufacture or import above a certain quantity and to communicate the results both to the authorities and to downstream user-customers. The REACH system includes the main contents as in Annex 5[5].
Pollution Control and Right-to-Know System——TRI or PRTR System
68. Pollutant Release and Transfer Register （PRTR）is the list or registration book for the release and transfer of toxic chemical pollutants from various sources to the environment, which includes the release data of toxic chemical pollutants from various of pollution sources to air, water and soil, and the transfer data of them to the pollution control facilities or disposal sites, and also includes integrated report of total situation of the toxic pollutants release to the environment.
69. Toxics Release Inventory （TRI）system is a major original version of PRTR system. The United States passed the “Emergency Planning and Community Right-to-Know Act”（EPCRA）in 1986, which established a TRI system, stipulating that all enterprises having the release of certain toxic chemicals regulated in the inventory up to a certain amount should annually report the amount released into the environment. At present, more than 600 toxic chemicals are reported in the TRI system. At the same time, EPCRA requires EPA to gather the above data, form a TRI report and publish it annually so that it is publicly available. The TRI system has been very effective with respect to pollution control and the prevention of major accidents of hazardous chemicals, e.g. gathering the release information of toxic chemicals which provided the basic support for identification of the risk, the evaluation of the effectiveness of the pollution control measures and then the environmental management decision-making.
70. Though the name and form of PRTR systems vary in different countries, it usually has the following basic elements: chemical pollutants are reported according to a toxic chemicals list）; industrial enterprises report; total release and transfer report; the fate of various of environmental media （air, water, soil）report; periodic report （annually）; unified data reporting formats and database systems; information open to the public （subject to protection of certain confidential commercial information）; improve environmental quality and promote cleaner production technology. Currently, PRTR systems have been established in most OECD countries. At the third meeting of IFCS, establishing a PRTR system was listed as one of the major targets of the chemicals management action of the international community after 2000. In May 2003, 36 European countries jointly signed a “PRTR Protocol” to build a unified PRTR system in the international community.
Environmental Standards and Monitoring System of Toxic Chemical Pollutants
71. In 1972, the “Clean Water Act”（CWA）issued by the United States put forward the “prohibit large emissions of toxic substances” policy requiring EPA to publish a list of toxic pollutants, and establishment an “adequate safety margin” standard. In 1977, the “Clean Water Act” amendment formally proposed a standard control inventory including 129 priority toxic pollutants, requiring EPA to establish corresponding emission standards of toxic pollutants for the temporal 21 types of industrial sources. Currently, water quality standards established by the United States, Europe and the WHO generally have more than 50 indexes, most of which are toxic pollutants. Current drinking water standards in the United States contain more than 50 kinds of toxic organic pollutants and more than 10 kinds of heavy metals and other inorganic toxic pollutants. Meanwhile, toxic pollutants are usually the important indexes in environmental standards of drinking water sources and hygienic standards of drinking water quality. In 1990, the United States put forward the toxic pollutant inventory including 189 species in the “Clean Air Act”, requiring EPA to establish and enact the emission and control standards for 41 categories of pollution sources. Till 1996, EPA had established the water pollution emission standards for 52 industries and the toxic air pollutant emission standards for 47 types of pollution sources.
72. In the EU, under the Water Framework Directive, a list of EU priority substances will be established[6], EU drinking water standards are also fixed in a Directive[7], and there are also rules on air quality[8].
73. Because of the many types of toxic chemical pollutants, they are often difficult to monitor on a day-to-day, routine basis, but in developed countries, toxic pollutants are always included in the annual environmental quality report. For example, the United States annual report on environmental quality has a specific chapter, “toxic chemicals”, reporting the actual results of toxic pollutants environmental monitoring throughout the country. Monitoring and reporting of the environmental pollution of certain priority hazardous chemicals is the basic work of chemicals environmental risk identification, assessment and risk management.
Major Hazard sources Management and Emergency Response Plan
74. Major hazard sources management and emergency plans system is a chemicals management system established especially for prevention and emergency disposal of major hazardous chemicals leakage accidents harming the environment and public health. In 1993, the International Labor Organization （ILO）organized countries all over the world to sign “Convention on the Prevention of Major Industrial Accidents” （Convention 174）, to make the major hazard sources management system be universally established in the world. According to the definition of Convention 174, “major hazard sources” refer to the facilities used for permanent or temporary production, processing, transit, use, disposal or storage of one or more than one kinds of hazardous chemicals whose volume exceeds the threshold value. Convention 174 regulates that member states should establish, implement and periodically review the national policy on protection of workers, public and environment and prevention of major accidents risks in accordance with national legislation, conditions and norms.
75. Major hazard sources identification standards and safety reporting system are basic elements of a major hazard sources management system. Annex 6, taken from the “Directive on Prevention of Major Accident Hazards of Dangerous Substances（96 / 82 / EC）”（Seveso Directive II）established in 1996 by EU, shows that this major hazard sources identification standard compartmentalizes the harmfulness of hazardous chemicals in accordance with the hazardous character and hazardous degree, which especially includes an “environmental harm” index. The EU major hazard sources identification standard is divided into two threshold levels, taking the management measures of different degree according to different magnitudes and differences in corresponding hazardous degree. EU classification identification standards of the major hazard sources have broad significance, and ILO has established the major hazard sources identification threshold for 180 species （categories）of chemicals according to Seveso Directive for reference by all countries in the world. The safety reporting system means that the enterprises with major hazard sources must first report various information and data related to major hazard sources to the governmental authorities, to carry on dynamic information management. Seveso Directive II respectively adopts the so-called “safety notification book” system and “safety report” system according to different magnitudes and corresponding different hazardous degree.
76. An emergency response plan is a plan or scheme established in advance of the possible major accidents or disasters, to ensure to that rapid, orderly, effective emergency and rescue actions are taken to reduce accidents and losses. It is an integrated and detailed arrangement based on the identification and assessment of potential major hazards, accident types, the possibility of occurrence, , consequences of the accidents and the severity of the impact, that elaborately designate the response agencies and duties, personnel, technology, equipment, facilities, materials, rescue actions and their command and coordination, etc. In general, the emergency response plan creates a systemic emergency response mechanism in which enterprise, government, community and the public all play an active role. Most government agencies are involved, such as public security, fire protection, environmental protection, medical care, sanitation and the media, etc.
77. In the United States EPCRA places toxic chemical accident emergency response plans within the legal system. In the EU, emergency response plans are part of the Seveso II Directive.
78. In 1993, the International Labor Conference passed “Convention on the Prevention of Major Industrial Accidents” also list emergency plans as necessary measures for prevention of major accidents.
Non-regulatory Measures and Actions on SMC in Developed Countries
Voluntary Agreement （VAs）
79. Since the 1990s, voluntary agreements signed between the government and the chemical industry in order to implement risk assessment and risk management of chemicals is developed widely in developed countries, and it has become an important means of environmental management policies on chemicals in many countries. European Commission statistics showed that among the more than 300 Voluntary Agreements on environmental management signed by European governments and businesses, the proportion of the VAs between the government and the chemical industry is nearly 30%, while the remaining several industries probably about 10%. There has been greater use of VAs in chemical environmental management in the USA and they have become a major means of implementing chemical environmental management policies and strategies. “33/50 Plan” is a VAs plan developed by EPA to reduce the polluting emissions of 17 species of toxic chemicals. In 1998, the government of the United States issued a government motion called “Chemical Right-to-Know” in order to accelerate the test of environmental and health hazard caused by chemicals and the publication of the risk information, and initiated the “HPV chemicals challenges （HPVCP）” and “Voluntary Child Chemicals Evaluation Plan”（VCCEP）, which have succeeded in establishing a working relationship among government, the chemical industry and public interest groups. Many community stakeholders voluntarily committed the hazardous test and risk assessment of most existing chemical substances and some preferential high risk toxic chemicals in more than 2800 HPV chemicals. In January 2006, EPA and 8 companies agreed on the “2010/15PFOA responsibility management plan”, in order to reduce and eliminate PFOA; and its related precursors step by step before 2015.
Responsible Care
80. “Responsible Care” is chemical industry’s voluntary action, hammering at improving the environmental, safety and health information and performance in technology, throughout a chemical’s life cycle, publicizing the information, communicating and cooperating with community stakeholders, prompting chemical businesses to take responsibility for chemical management in chemical industry and supply chain, and to protect the environment and human health.
81. The ideas of RC were first initiated by the Canadian Chemical Producers Association in 1985, and they were then adopted by the U.S. Chemical Manufacturers Association and the Chemical Industry Association of the EU and Japan. Later, under the promotion of the International Council of Chemical Associations （ICCA）, they have been adopted in 52 countries around the world; the production volume of those enterprises taking part in them is close to 90% of the global total. ICCA specially set up RC leading group responsible for the cooperation with the national chemical industry organizations, developing and improving the rules of RC, and continuing to promote the wider use of the RC norms. The RC operations are mainly implemented by chemical industry associations. ICCA/RCLG developed 8 terms of RC core criteria which should be followed by all of the countries. Also chemical companies must sign a formal commitment protocol, and take corresponding actions.
82. RC movements were recognized by UNEP at the Johannesburg Conference on sustainable development in August 2002.
Green Chemistry
83. The “Green chemistry” project aimed at establishing extensive partnerships among the governments, scientific and technological circles and industry’s research institute to develop the innovation design of environmentally friendly products and the process, reduce environmental and health risks from chemicals. In 1991, EPA pollution prevention and toxic substances office （EPA/OPPT）launched the “pollution prevention substitutive synthetic route” plan. Its four main areas include: （1）Green chemistry research projects: in 1992 and 1994, EPA / OPPT signed a memorandum of understanding with the National Science Foundation （NSF）, to build a partnership, establish a “sustainable environmental technology” Assistance Program, jointly funded green chemistry research. The Presidential Green Chemistry Challenge Program is an annual award scheme for outstanding performance of the chemical industry in promoting green chemistry Awards are given to honor those who promote green chemistry. Under the Green Chemistry Education Program, EPA and the American Chemical Society （ACS）establish partnerships and promote green chemistry education among chemical engineers, students and research staff in university or scientific research institutions. Under the Green Chemistry scientific communication plan, the “green chemistry” project provides funds to various industries, policy makers and the scientific community for green chemistry science, technology advocacy and popular activities.
Basic Principles and Policies in SMC in Developed Countries
84. Based on the systems and general practices of environmentally sound management of chemicals in developed countries, several basic principles and policies could be summarized as follows.
Prevention and Precaution
85. Many chemicals that had been produced largely and applied widely but lately were testified harmful to the environment and human health, such as DDT, PCBs in 1970s and PFOS recently. They have caused countries to introduce systems that require generation of information before new substances are produced or placed on the market （prevention）. Furthermore “to protect the environment, every country should take appropriate precautionary measures. Where there are threats of serious or irreversible damage lack of full scientific certainty should not cause a country to delay cost- effective measures to prevent environmental degradation.” This basic approach was embodied not only in the basic policies and systems of environmental management of chemicals in developed countries and is reflected in the U.S. toxic chemicals regulatory regime, such as with respect to the notification systems of new chemicals, and the risk assessment and risk management systems of existing chemicals, but also underpins the new REACH Regulation. A balance was found in the new Regulation between the burden that enterprises will have to face and the amount of information to be generated on the hazards and risks of substances on which the risk management measures will be based.
Priority Management
86. At present, there are probably over 100,000 industrial and commercial chemicals circulating on the market. Many countries therefore adopt “priority management” as the basic policy and principle of environmental management of chemicals and first manage the chemicals which have higher health and environmental risk, such as HPVCs, PBT, vPvB and CMR. “Priority management” is not only carried out in every basic system of environmental management of chemicals, such as environmental monitoring of toxic chemicals, PRTR, control of major pollution, but is also embodied in international treaties such as POPs and PIC, etc.
Polluter Pays, “Burden of Proof” and Sharing Responsibility
87. During the strategy and system reformation of the environmental management of the chemicals in Europe in recent years, the responsibility of chemicals environmental management has been mainly devoted to manufacturers and importers. In REACH, downstream users are included as well, however the main burden with regard to the generation of information on hazards and risks lies with the manufacturers and importers. The REACH Regulation takes a different approach than United States where the government is mainly in charge of hazards test as well as risk assessment. REACH requires that the chemical manufacturers and importers are mainly responsible for hazard testing and risk assessment.
Public Participation
88. PRTR system as well as VAs and RC action widely pursued by chemical environmental management in developed countries to promote public participation.
International Policies and Actions on Environmentally Sound Management of Chemicals
89. In the 1992 Rio Conference on Environment and Development, the sound environmental management of chemicals was written into the sustainable development of human society programmatic document “Agenda 21”. Since the 21st century, international chemicals management activities developed especially in three areas: the gradual promotion of the Globally Harmonized System of Classification and Labeling of Chemicals （GHS）; the extensive subscription of the chemical environmental management conventions; and the Strategic Approach to International Chemicals Management.
Globally Harmonized System of Classification and Labeling of Chemicals
90. Human society has developed a gradual awareness of hazards caused by chemicals. A classification system for hazardous chemicals was first applied by the United Nations Exports Committee on dangerous goods in the 1950s. It produced the concept of hazardous chemicals, and divided them into explosives, compressed gas / liquefied gas, flammable liquid, flammable solid, spontaneous articles / contacting-water-flammable materials, oxidizers / organic peroxides, drugs, radioactive materials and corrosion materials in total of 8 Classes. As human understanding of the hazardous caused by chemicals expanded, particularly for chronic, potential health and ecological hazard, the EU adopted the Directive 92/32/ EEC （the 7th Amendment of 67/548/EEC）to amend the existing classification system, expanding the classification of harmful chemicals from 8 to 15, and mainly adding health and environmental hazard categories of “sensitizing”, “carcinogenic”, “mutagenic”, “toxic for reproduction” and “dangerous for the environment”. In 1992, the establishment of GHS became an important element of international chemicals environmental management strategies in “Agenda 21”. In 2003, GHS was completed and published. The basic classification system is shown in Annex 7. The international community has made the promotion of GHS in 2008 a basic strategic goal of international chemical management actions. GHS will become the future uniform classification system for hazardous chemicals generally followed by countries, and will greatly promote the process of international chemicals management.
Chemical Environmental Management International Conventions
91. In 1998, the international community came to an agreement on “Rotterdam Convention On the Prior Informed Consent Procedure for certain hazardous Chemicals and Pesticides in international trade”. In 2001, it reached agreement on “Stockholm Convention on persistent organic pollution”. UNEP and other international organizations are also active in their continued assessment of mercury and endocrine disrupting chemicals globally.
Strategic Approach to International Chemicals Management — SAICM.
92. This global voluntary initiative is built on the concept that “chemicals or chemical uses that pose an unreasonable and otherwise unmanageable risk to human health and the environment based on a science-based risk assessment and taking into account the costs and benefits as well as the availability of safer substitutes and their efficacy, are no longer produced or used for such uses.” The World Summit on Sustainable Development （WSSD）in 2002 developed an Implementation Plan for push forward the world to achieve sustainable development goals of a 21st Century Agenda. The Implementation Plan sets a strategic and time-specific goal to achieve environmentally sound management of chemicals: “to achieve the sound management of chemicals throughout their life-cycle so that, by 2020, chemicals are used and produced in ways that lead to the minimization of significant adverse effects on human health and the environment.”
93. From Feb. 4-6 2006, through the common efforts of the international community, the “Strategic Approach to International Chemicals Management” was identically passed in the international chemicals management convention and 9th special conference of UNEP council global environment ministerial conference held in Dubai, United Arab Emirates.
94. SAICM and WSSD both help to achieve the objects of minimizing chemicals’ environmental and health risks, bringing forward collective policy strategies and a series of unified strategies and action schemes with time lines to synthesize and harmonize existing international chemicals safety management actions, including risk reduction, knowledge and information, public treatment, capacity building, and technology cooperation.
Gap Analysis of SMC between China and Developed Countries
Differences in Guidelines of Environmental Management of Chemicals
Guiding Principles for Environmental Management of Chemicals
95. Safe production of hazardous chemicals in China must ensure the safety of people’s life and property, and prevent accidents and environmental pollution. According to ‘Regulation on safe management of hazardous chemicals’, supervision and management scope includes the production, placing on the market, storage, transport, use and disposal of hazardous chemicals, but the regulation places particular emphasis on labor production safety and prevention of chemical accidents, while it does not emphasize health and environmental safety. The environmental supervision and management of chemicals by SEPA focuses particularly on hazardous chemicals with acute toxicity. Environmental management also particularly stresses the “end of pipe treatment” of discharged chemical pollutants.
96. The decision-making with respect to safe and environmentally-sound management of chemicals in China is basically according to certain inherent properties of a chemical and the degree of potential hazard, but less considering its exposure scenarios and risks. For example, China implements a very strict license management system for acutely toxic chemicals, including systems on purchase voucher, purchase license, record-keeping and registration and record of users et al. The 335 acutely toxic chemicals listed in “List of Management of Acutely Toxic Chemicals” in China are determined entirely by the acute toxicity of chemicals to mammals: Determining indicators do not involve the chronic toxicity health harm factors directly related with chemicals, such as the possible chronic toxicity, especially for carcinogenicity, mutagenicity, reproductive toxicity and other special toxicities caused by long and repeated exposure to chemicals, environmental fatalness including biological toxicity, persistence and bioaccumulation et al., volume and methods of use and so on in the long-term and repeated exposure to chemicals. China still lacks a set of comprehensive and scientific policies and guiding principles for the environmentally-sound management of chemicals.
Key Objects of Chemicals Environmental Management
97. Environmentally-sound management of chemicals should establish clear objectives and management focus to spend the limited resources on priority areas for improvement.
98. Hazardous chemicals under key management in different countries generally have the following characteristics: （i）chemicals with carcinogenic, mutagenic properties and those toxic to reproduction, teratogenicity （CMR chemicals）; （ii）PBT chemicals with persistence, bioaccumulation and toxicity; （iii）chemicals with dangerous characteristics, such as toxicity, flammability, explosiveness and hazardous to the environment and so on, which may lead to a major hazard installation when their production or storage volumes exceed a certain threshold value.
99. Safe management of hazardous chemicals in China doesn’t distinguish between specific key objectives and general objectives. For any hazardous chemicals, no matter how serious the hazard, use volume and possible exposure are, relevant departments must implement registration management of it, and review and issue safe production licenses or operating licenses to relevant production and operating units. Currently there is no prioritization mechanism for the numerous existing chemical substances produced and marketed. Neither is there any requirement for production enterprises to carry out tests to determine its inherent hazards and assess the risks, nor any measures on identifying and managing PBT and CMR chemicals, which are chemicals of very high concern.
Social Responsibility for Enterprises
100. Inherent dangers and risks information of a chemical substance is important not only for proper risk control of chemical, but also for protection of environment and human health, accident prevention and emergency rescue. In developed countries chemical manufacturers and importers have the clear responsibility to provide chemical safety information to the government, company staffs, their customers and to consumers. Enterprises which cause chemical contamination risks should be responsible for carrying out proper classification, packaging and labeling of the hazardous chemicals that they produce, providing the safety evaluation data of chemicals that they produce and sell, assessing the risks and identifying appropriate measures to control the risks, and for monitoring the risk management, the prevention and control of chemicals pollution taken by the competent departments of government.
101. Competent departments of chemicals in China lack understanding of the importance of requiring manufacturers and importers of chemicals to establish and report chemicals safety data by the laws and regulations implemented to identify and manage chemical risks. Although China follows the “polluter pays principle” and implements the pollution discharge system, the establishment and report of chemical safety information are not taken as the unshakable social responsibility for production and import enterprises in the chemicals management. Existing regulations like “Regulation on safety management of hazardous chemicals” do not require enterprises to develop tests of chemicals that they produce or import and to submit testing data and risk assessment reports. Furthermore, given the insufficient analytic ability of the testing laboratories for the supervision and management of chemicals, most of the industrial chemicals produced in China, even high volume chemicals, are not required to undergo hazard testing and assessment and cannot be classified and labeled properly, and their risks are not managed adequately.
Differences in Regulations and Management Systems
102. China lacks a comprehensive basic law or administrative regulation by the State Council on environmental pollution prevention and control and the management of industrial chemicals.
103. The main differences in regulations of environmental management of industrial chemicals and corresponding management system in China and developed countries are as follows:
Gaps in Control of New Substances
104. China began to implement the notification system of new chemical substance in October 2003. On the basis of identification and evaluation of health and environmental risks of new substances, the new substances according with the standards of hazard evaluation are required to register, before production and import, while chemical substances with high health and environmental risks are banned or restricted with respect to production and use.
105. Implementation of report and registration system of new chemical substances is still at beginning stage. Methods of assessment of new chemical substances are basically based on hazard evaluation, so there are many aspects of exposure evaluation and environmental risk assessment that need improving. ‘Provisions on the Environmental Administration of the New Chemical Substances’ issued by SEPA is a ministerial rule. Due to its low legal position, the executive implementation is quite unsatisfactory. There is also a big gap in implementation of Notification and Review System of New Chemical Substances in China compared to developed countries.
Gaps in Control of Existing Substances
106. Considering the numerous existing chemical substances produced and sold before chemical safety legislation was developed, and because there is no requirement for testing, evaluation and assessment of risks of most existing chemical substances, it is difficult to achieve accurate hazard classification and safety management. Starting from the idea of prevention and control of risks of chemicals of high concern and the implementation of key safety management, developed countries have universally established the priority chemical test, evaluation and assessment system. Priority chemicals are chemicals which may cause or are likely to cause serious adverse effects to human health or the environment, and are listed on the priority list by competent authorities for testing and evaluation to impose controls.
107. China has no regulation for prior testing and evaluation system of existing chemicals. There are no legislative provisions for screening of chemicals for potential health and environment risk, and relevant risk assessment in existing laws and regulations for safe management of chemicals. At present, China has established a system on prohibition or restriction of production and use of the chemicals under such international agreements as the POPs Convention and PIC Conventions. However, it is difficult for its national competent authorities to take timely countermeasures to forbid the production and use or limit the use of other chemicals of very high concern.
108. Chemicals of very high concern may be exported from developed countries to China, which might lead to a significant increase in risk relevant to hazardous chemicals and safe production in addition to the domestic safety problems.
Report and Emergency Plan of the Major Hazardous Installations – Gaps in Control of Major Installations
109. In China hazardous chemicals only include four categories of dangerous substances – those with explosive, combustibility, reactivity and acute toxicity characteristics. They do not include carcinogenic substances and environmentally hazardous substances and there are only 142 substances in the control list, but due to the lack of any Category criteria, it is impossible to identify other key sources of dangerous substances. Because many such substances, which have attracted international attention, are not included in the national standards on identification of major hazard installations, and the report and emergency plan system of major environmental hazard installations is not established, it is impossible to ensure effective implementation of prevention and emergency management of accidents of environmentally hazardous chemicals.
Register System of Pollutant Release and Transfer: Gaps in Emission Control
110. Since the early 1990s, according to the authorization of environmental laws and regulations like Law on Prevention and Control of Water Pollution, Law on Atmospheric Pollution Prevention and Control et al., China has promulgated and implemented the “Provisions on administration of report and registration of pollutants discharge”. There are 12 pollutants （COD, oil, cyanide, phenols, arsenic, mercury, cadmium, hexavalent chromium; smoke, dust, sulfur dioxide and industrial solid）the discharges of which are controlled, but other chemical pollutants are not included in the system. Implementation of the system enables environmental protection departments of the government to acquire discharge information of major pollutants from national enterprises, for environmental management purposes including checking the basis of pollution discharge, environmental statistics, analysis of pollution sources, and environmental planning, et al. The information acquired by report and registration for pollution discharge is regularly published in the “Annual Statistic Report on Environment in China” by SEPA for public inquiry usage.
111. There is no PRTR system for environmental management of chemicals in China, and the existing system of pollution discharge reporting and registration is very different from the international PRTR system Because it is hard to master and announce information on production, use, discharge and pollution prevention of environmentally hazardous chemical substances of high concern on health and environment, environmental management of chemicals is not fully reflected in pollution prevention regulations and management policies.
Classification and Labeling System of Chemical Hazards: Gaps in Classification Management
112. Classification and labeling of chemicals is an important means for hazard communication of chemicals. Developed countries have generally established and perfected communication systems for the classification, labeling and material safety data sheet （MSDS）of chemicals. China has already established a classification, labeling and MSDS system of hazardous chemicals. Hazardous chemicals in the existing ‘Name list of chemicals’ refer to the list of hazardous chemicals in the U.N. ‘Recommendations on the transport of dangerous goods’. Chemicals in the current classification system of U.N. ‘Globally Harmonized System Classification and labeling of Chemicals （GHS）’ with other health and environmental hazard are not included within the scope of hazardous chemicals in China. There are no or very few chemicals of high concern with CMR and PBT characteristics within the scope of safety management in China.
113. Existing “List of Hazardous Chemicals” in China is also established in accordance with the list of hazardous goods in the UN “Recommendation on the Transport of Dangerous Goods”, and only includes about 3,000 hazardous chemical substances. For substances or preparations for marketing but not included in the list of hazardous chemicals, manufacturers are not required to make risk assessments and carry out classification and labeling of other hazardous chemical substances or preparations. It is urgent to revise and perfect the category of classification and management of existing hazardous chemicals according to the United Nations GHS classification standards.
Differences in the Supervision and Management Methods
114. In order to prevent and control risks of chemicals, developed countries take many measures and countermeasures including （i）testing chemicals to identify their inherent properties; （ii）carrying out classification and labeling of dangerous chemicals and making dangerous warning marks; （iii）establish exposure scenarios and assess the risks, （iv）transferring and notifying hazard and risk information of chemicals by establishing MSDS and notifying information to the authorities; （v）taking measures to ban or restrict use of chemicals et al., when there is no appropriate way to control chemical risks.
115. In China, the competent departments favor command and control license management system and methods of registration management, but rarely consider other means to encourage and facilitate enterprises to voluntarily participate in the safe management of chemicals. Many leaders of domestic enterprises regard chemical safety and environmental protection as what the country requires and they have to deal with, rather than as a social and ethical responsibility of the enterprise. There are great gaps in the right-to-know and participation of the public on chemical safety and environmental protection decision-making between China and developed countries.
116. Considering the gaps mentioned above, priority area of Environmental Management of Chemicals in China should include following aspects:
Insufficient Regulations and Standards System of Environmental Management of chemicals
117. China has established management of special chemicals like pesticides, pharmaceuticals, veterinary drugs, and food additives, which keeps up with the international management program and standard of safety assessment of in-kind chemicals, but needs a set of laws or regulations on pollution control of environmental safety for industrial chemicals. There are many blank spots and imperfections in the aspect of industrial chemicals risk identification and assessment, authorization management system and pollution control standards, et al. Compared with the international chemical safety management system, there are great differences in chemical health and environmental risk assessment and management and hazardous chemical classification and labeling system in China.
118. Current laws on environment prevention, such as ‘Law of prevention and control of atmospheric pollution’, ‘Law of prevention and control of water pollution’ and ‘Law of prevention and control of environmental pollution by solid waste’, place particular emphasis on end-of-pipeline controls on chemical pollution..
119. Therefore, it is necessary to establish a set of laws or administrative regulations of the State Council on pollution control of industrial chemical environment safety, and take measures of risk prevention and management to solve the pollution prevention problems of environmentally hazardous chemicals.
120. In order to identify and evaluate risks to human health and environment caused by chemicals, chemicals risk assessment guidelines, standards, chemicals environmental standards （such as quality standards of atmospheric environment and water environment, and pollutant discharge standards）, and management technology standards, et al. are needed.
Lack of Clear Principles and Guidelines for Environmentally-Sound Management of Chemicals
121. There is no comprehensive and scientific management policy and guiding principle for environmentally-sound management of chemicals in China. For the following series of problems involved in national environmentally-sound management of chemicals, the clear policy guidance should be suggested by research:（1）What are the position and importance of environmentally-sound management of chemicals within the overall strategy on national environmental pollution prevention and control?（2）What are the objectives and guiding principles of environmentally-sound management of chemicals?（3）What are the similarities and differences between environmentally-sound management of chemicals and safe management of chemical? （4）Which categories of chemicals should be subject to environmentally-sound management? （5）How to screen priority test substances from huge quantity of existing substances and assess to determine the list for priority management chemicals? （6）How to strengthen capacity building for environmentally-sound management of chemicals?
122. China cries for more international cooperation, and needs to establish environmentally-sound management of chemicals by referring to the successful management experience and effective practices of developed countries.
Strengthening of Enforcement and Supervision Abilities of Environmental Protection Administrative Departments
123. Although there are a series of environmental laws, regulations on management and prevention of environmental pollution of chemicals in China, for the numerous management links of production, management, usage, import/export and prevention of pollution from hazardous chemicals, and lack of personnel and necessary measures and experiences for evaluation and supervision, all of the above lead to insufficient safe and environmental supervision and management by some administrations. Especially in cities and towns with districts under the provincial administrations, many laws and regulations are not effectively implemented.
124. As a developing country, people's standard of living in many areas is low and China needs to develop the economy to resolve social problems such as food and clothing. For the consideration of economic benefit, some local administrations provide poor supervision, which leads to ineffective supervision and management of chemicals. It is urgent to enhance the understanding of people at all levels of environmental protection administrative departments on the importance of environmentally-sound management of chemicals, and strengthen the capacity building of executed supervision and management mechanisms.
125. Secondly, building a system for the environmentally-sound management of chemicals in China is still in the initial stages. With respect to environmental pollution prevention, there are neither clear guidelines for environmentally sound management of chemicals, nor the establishment of chemical risk assessment and risk management systems and technical guidelines that are in accord with international initiatives. China also lacks the experts needed to support a system of environmental risk assessment of chemicals and to develop the necessary evaluation and supervisory capacity
126. At present, the focus of national pollution prevention is still on prevention and control of problems caused by “three wastes” at the end of the pipeline of industrial production, and environmentally sound chemicals management has not yet been added as an important item on the environmental protection agenda. The State has not yet developed definite principles of environmentally sound management of chemicals policies to establish environmental risk assessment and risk management systems and technical guidelines that are in accordance with what the international community has done. The state also lacks the ability to support a chemical risk management system and to evaluate and monitor management.
127. Third, enforcement managers of environmental protection lack the necessary training. The lack of experienced, well-trained hazardous chemicals environmental managers and professional and technical personnel is also a constraint on effective implementation of supervision and management.
128. The reform of the State Council and local governments and the reduction of personnel in all levels of environmental departments, would result in a great change of personnel and great changes in management posts. Currently, the protection agencies of environmental protection bureaus at the provincial and city levels only have 1 or 2 part-time management officials in charge of prevention of environmental pollution from toxic chemicals. Both of the discordant management capacities of managers and their unfamiliarity with relevant laws and regulations on environmental management of chemicals restrict supervision and management.
129. It is urgent to strengthen the technical training of environmental protection managers at all levels, improve their understanding of the importance of environmentally sound management of chemicals and improve their ability to manage, supervise and enforce.
Insufficient Technical Supporting System of SMC
130. The establishment of a technical support system for environmentally-sound management of chemicals is the important technical support for and guarantee of safe management of chemicals. The technical supporting system includes the criteria of a qualified laboratory system for testing and analysis of chemicals, guidelines for testing and evaluation, principle of qualified laboratory and risk assessment et al., and safety information management system of chemicals.
131. There is no unified qualified laboratory standard for testing and evaluation of chemicals in China. Most of the laboratories are not testing according to internationally agreed “Qualified Laboratories Norms Principle of OECD”, and are not certified by national bodies, so they cannot ensure the reliability of testing results and meet the domestic demand of testing data for safe and environmental management of chemicals. The administrative departments of environmental protection, health, agriculture, safe production et al. and their technical supporting units have established their own chemicals registration and management database systems, and carried out related information queries through a chemicals safety database system established by foreign authorities, such as the RTECS database of NIOSH, USA, Hazardous Substances Data Bank （HSDB）of USA medical libraries, the INCHEM database of IPCS of UN, Search System for the International Chemical Safety Cards et al.. However, it is still difficult to obtain basic information on domestic production, use, location of production equipment and the storage, transport and disposal of chemicals, pollution hazards to human health and the environment by exposure of hazardous chemicals, hazard characteristics, toxicity, environmental fate and potential effects on health and environment of related chemicals and chemical products et al. It is difficult for the public to obtain information on classification indicators, fire protection, leakage disposal, and safety protection and pollution prevention of hazardous chemicals. Therefore, establishing and perfecting the management and notification system of safety information on chemicals is also an important issue in strengthening capacity building when it comes to environmental management of chemicals in China.
Recommendations for Policies and Regulatory Framework Building for SMC in China
132. With increased globalization, developed countries have been facing various environmental problems step by step while today developing countries have to face these problems simultaneously. In China, environmental pollutions are characterized as “multiplex and compressed”. China is facing either the traditional or the first generation of environmental problems like city air pollution or lake eutrophication and so-called “new” or “second-generation” environmental problems like environmental issues of chemicals at the same time. Attention as well as understanding of environmental issues and environmental management of chemicals has always been insufficient. In addition, the current chemical management system is a traditional chemical hazard classification system which has great limitations both in management scope and goals. Chemical management in China so far, in fact, is primarily focused on the occupational safe management of specific hazardous chemicals with highly active physical and health hazards, i.e. flammable, explosive, acutely toxic chemicals etc., and there are many gaps in environmental management for a large number of chemicals with potential and long-term hazards to human health and environment. Because of the lack of a basic legislative and administrative foundation, the SMC in China requires improvement. The current environmental management related to chemicals is primarily limited to end of pipe treatment of a few toxic chemical pollutants rather than pollution prevention measures, which does not reflect the basic principles and methods of environmental management of chemicals, such as precaution and risk management.
133. While the environmental management of chemicals is underdeveloped, China is facing increasingly serious pollution from chemicals: many hazardous chemicals widely controlled internationally, are still produced and used without restriction in China. In addition, accidents involving hazardous chemicals happen frequently. Due to this, the ecological and health risks caused by chemicals in China are increasing. Besides, since the beginning of the 21st century, the developed countries have been constantly strengthening their environmental management of chemicals. Results are mainly reflected in legislation and a variety of measures to speed up testing, evaluation and management of health and environmental risks of chemicals. The international community vigorously pushes forward the global agenda on environmentally sound management of chemicals, which was always an important component of the global strategy of sustainable development, and has put forward a strategic goal and the corresponding strategic action plan - SAICM. The SMC is directly related to environment safety and human health in China. China is committed to reform the industrial infrastructure and build an environment-friendly society. Environmental management of chemicals was sure to be put on the agenda of national environmental protection in the context of scientific development.
134. Based on an integrated analysis of the situation of environmental management of chemicals in China and the experience of developed countries and international policies, the following suggestions are put forward regarding policies and regulatory framework for the SMC.
Establish a National Strategy on SMC
135. Generally, all future measures on SMC should become a part of the national strategy.
Recommendations
A. The strategy of SMC in China should define the basic guidelines, principles, policies and overall strategic objectives of the nation’s SMC, which should comprehensively consider the precautionary approach and the basic national situation of chemical industry and consumption of chemicals and set reasonable strategic objectives.
B. The strategy shall be consistent with ‘scientific development’. To promote recycling and reuse, to protect the environment, to promote a resource-conserving and environment-friendly society, clean and safe development should be considered in the strategy.
C. The manufacture and management of chemicals shall follow the ideas of clean production and green chemistry.
D. Chemicals with high risks to health and environment should be replaced first provided economically feasible alternatives are available.
E. The strategy of SMC in China should establish a national plan of capacity building on SMC including the legislative system, institutional functions, technical supporting systems, information exchange and public participation mechanisms etc.
F. Chemicals management strategy should include a long-term action plan for risk assessment and risk management of existing chemicals with set deadlines, following national specific priority principles to collect information on hazards of existing chemicals, carry on risk assessment and risk management actions, gradually reduce and eliminate the production and consumption of chemicals with unreasonable risk to the environment and human health, and last but not least achieve China’s “environmentally friendly environment”. The strategy chosen must be WTO compliant.
G. For development of the national strategy of SMC, one national coordination group should be established from environment and human health protection basis to insure the drafting strategy to reflect on interests of the stakeholders.
Establish a Law or Administrative Regulation on SMC
136. In light of current national legislation in regard to chemicals management establish a specialized law or an administrative regulation on SMC as the fundamental way to fill most of the existing gaps in SMC in China.
Recommendation:
A. The law or the administrative regulation of SMC should comply with the approach of risk management, establish hazard testing requirements, adopt the GHS for classification and labeling of chemicals to contribute to effective risk assessment and risk management of chemicals, include the GLP requirements for new tox and ecotox tests, establish basic SMC systems mainly including new chemical substances notification, risk assessment and risk management of existing chemical substances, environmental monitoring system for priority toxic chemical pollutants, information gathering and a right-to-know system for the release of toxic chemicals, a major environmental accident prevention and emergency response system, which should be coordinated with the current relevant legislation on occupational safety and public health management.
Priorities for Basic Administrative Framework （System Building）on SMC
Implementation of GHS as Soon as Possible in Accordance with Internationally Agreed Goals
137. A scientific and comprehensive system of classification and labeling of chemicals is a fundamental condition of chemical hazard identification to contribute to effective risk assessment, information communication and risk management of chemicals. The currently used classification system from hazardous chemicals in China does not fully reflect various potential environmental and health hazards and risks of chemicals, which severely restricts the development of SMC in China.
Recommendation:
A. Comprehensively implement the GHS for the classification and labeling of chemicals as the basis for new chemical substances notification, risk assessment and risk management of existing chemical substances, and major hazardous installation management system, MSDS system and other systems. This requires manufacturers and down-stream users of chemicals to classify, label and communicate information on the hazards of chemicals according to the GHS in order to effectively control environmental and health risks of certain chemicals.
Promote and Improve the New Chemical Substance Notification System
138. New chemical substance notification is a basic element of SMC. Developed countries have established such a system through specialized legislation in the 1970s, and built up a system with comprehensive guidelines, procedures and good technical and institutional supporting systems. By contrast, the new chemical substances notification system in China was established only three years and launched by a ministerial rule.
Recommendations:
A. Raise the legal status to strengthen enforcement and establish a specialized legislation for SMC containing the system proposed above.
B. Take full advantage of advanced experience from developed countries to further improve the enforcement procedure and the cooperation mechanism among relevant government departments.
C. Create obligations to improve domestic cooperation and information exchange in both ways between relevant ministries and authorities horizontally and vertically
D. Improve the corresponding technical guidelines and institutional supporting systems, such as GLP criteria and the international mutual recognition of test data, etc., so that the new chemical substance notification system is in accordance with international systems.
E. Streamline procedures and introduce mechanisms to reduce bureaucracy for cases of less concern such as chemicals in very small quantities or samples. Pay special attention to those chemicals with high risk to health and the environment.
Establish the System of Risk Assessment and Management of Existing Chemical Substances
139. A system of risk assessment and management of existing chemical substances is the basis of collection of risk information of existing chemical substances and risk management. It is also the emphasis of current environmental management of chemicals all over the world. Because of the deficiency of the system, the Chinese government had little awareness of current domestic environmental and health risks of chemicals, did not conduct administrative measures for chemicals with high risks, and always lagged behind the international chemical management approaches.
Recommendations:
A. Build upon a system of risk assessment and management of existing chemicals close to the requirement of testing and data corresponding to new chemical substances notification, which will mainly include: establishment of a system of priority setting and a system of collection of hazard and risk information of existing chemical substances,
B. Regulate the obligation of the producers or importers on hazard testing and information notification, whose production or import of existing chemical substances is above a specific volume and collect the hazard and risk information on existing chemical substances in the market;
C. Put forward basic principles, policies and regulations of priority risk management, e.g., prohibition or restriction of production, use, import and export on priority chemicals, such as PBT, CMRs and vPvB, etc.;
D. Carry out classification and labeling of existing chemical substances according to GHS;
E. Determine the implementation mechanisms of the system of risk assessment and management of existing chemical substances; establish specialized legislation for SMC containing the system proposed above is the appropriate way forward.
Establish National Criteria for the Prioritisation of Chemicals of High Concern
140. National criteria for the prioritisation of chemicals of high concern shall be established according to domestic situation of the chemical industry while taking account of international criteria.
Recommendations:
A. Set criteria and procedures for prioritisation of chemicals of very high concern while taking into account international criteria for prioritization of toxic chemicals, types （number of chemicals）, and volumes of domestically produced and imported existing chemicals. Nationally prioritized chemical types may include PBT, vPvB, CMRs and EDCs, etc.
B. The risk management of priority chemicals should be based on their different features and their potential risks and hazards towards environment and health. It should take into consideration the exposure during production, utilization and distribution of those prioritized toxic chemicals. Establish national principles for risk management of priority chemicals. Based on this approach, reformulate risk management policy and systems for prioritization of chemicals of very high concern such as PBTs.
C. Draft a risk management strategy and action plan, in a step by step manner to reduce, restrict or ultimately ban the production and consumption of those chemicals of very high concern to promote the implementation of the Stockholm Convention and other international agreements and arrangements on chemicals management.
Establish a System of Release Recording and a Publication System for Toxic Chemical Pollutants
141. The PRTR is a model for gathering emission statistics on toxic chemical pollutants and informing the public. This type of system acts as a control of environmental pollution of toxic chemicals, prevention of accidents, information publicity and public participation in many countries.
Recommendation:
A. Make suggestions to assimilate successful experiences from abroad, adopt specific principles of priority management, rationally determine the extension of inventory, industry and enterprises of toxic chemicals which are needed to notify, establish corresponding management information system of collection and publication of data, and gradually establish the system of collecting emission statistics of toxic chemical pollutants and informing the public in China.
Establishment of Environmental Monitoring System for Emissions of Priority Toxic Chemical Pollutants
Recommendation:
A. Establish a system for the monitoring of priority toxic chemical pollutants, such as PBTs etc. commensurate with the capacity of the existing Chinese environmental and hygiene monitoring system carry out institutionalized and systemic environmental monitoring of the chemicals with high ecological and health risks, compile and release an annual report on the monitoring of national priority toxic chemical pollutants to enable the government and community to understand the situation of environmental pollution from chemicals and their ecological and health risks and provide the basis of decision-making for the efficient promotion of environmental management.
Improve the System of Registration and Reporting of Major Hazard Installations
Recommendation:
A. Revise standards of identification of major hazard installations （especially need to add corresponding categories and standards of environmentally hazardous substances）, improve the current mechanism of implementation and supervision of the registration and reporting system for major hazard installations, enhance data sharing and the responsibilities and rights of supervision and implementation in the system of registration and reporting of major hazard installations, strengthen the law enforcement ability of relevant organizations, sufficiently prevent serious leakage accidents of hazardous chemicals and their environmental effects. Improve the relevant legislative system for the management of existing major hazard installations by reference to relevant international rules and practices of management of major hazard installations, such as ILO, EU Seveso Directive and EPCRA etc.
Capacity Buildings
Build upon Existing National Administrative Functions and Organizations for Environmental Management of Chemicals
Recommendations:
A. Build upon the national system of administrative enforcement of environmental management of chemicals, supervision and management by setting up a coordination mechanism among all national level authorities responsible for chemicals management.
Elevate the role of SEPA within the Chinese chemical management system including by increasing the capacity of relevant divisions and departments. Set up specific administrative functions （departments or divisions）for chemicals management and increase the number of staff involved in environmental management of chemicals in central and provincial organizations for environmental protection, including additional relevant managerial departments and officers.
Reinforce corresponding staff training.
Establish a Comprehensive National Information System for Chemicals
142. Availability of information on hazards of chemicals and risks is necessary for environmental management.
Recommendations:
A. Carry out centralized collection, arrangement and publication of various relevant national information on environmental and health risks of chemicals based on systems such as notification of new chemical substances, risk assessment and risk management of existing chemical substances, environmental monitoring of priority toxic chemical pollutants and their emissions and registration and reporting of major hazard installations, consistent with the protection of confidential business information.
B. Link existing national chemical information sources and management system such as those concerning existing and new chemical substances, as well as occupational health and safety issues.
C. Further enhance global information exchange on chemicals.
Strengthen National Capacity on Testing, Evaluation, Research and Monitoring of Chemicals
143. Promote cooperation among departments including those managing national environmental protection, public health, science and technology, and others in the following areas.
Recommendations:
A. Increasing capacity for testing of environmental and health hazards of chemicals by establishing laboratories for testing and evaluation of chemicals in accordance with OECD / GLP guidelines and by introducing GLP monitoring and other programmes such as mutual acceptance of data （MAD）.
B. Increasing capacity to conduct basic research on and to monitor the environmental and health components of risk assessment, particularly with respect to priority high-risk and toxic chemicals.
C. Development of international cooperation related to hazard testing and risk assessment of chemicals, learn and adopt international chemical risk assessment practices to continually improve capacity in China.
D. Strengthen Environmental Governance on Chemicals
Promote and Support Policies for Voluntary Risk Management of Chemicals
144. While gradually improving the governmental management system, promote participation of all chemical stakeholders, especially the wide participation of the chemical industry as the basis for successful implementation of state environmental policies for the sound management of chemicals. Voluntary Agreements（VA）between government and enterprises and Responsible Care（RC）action taken by chemicals enterprises are good practices carried out for the environmental management of chemicals in developed countries. The Chinese Cleaner Production Promotion Law has already established the legal status of VA, and put forward a number of incentive policies.
Recommendations:
A. Encourage the implementation of VA, RC and Product Stewardship in China, in communication with Chemical Industry Association. Research and establish a series of relevant matching policies and measures of management to promote the gradual implementation of VA and RC of environmental management of chemicals in China on the basis of current regulations of Cleaner Production Promotion Law.
B. Improve performance under VAs including by clarifying their legal status, and control procedures, and engaging in performance audits.
Improve Information Publicity and Public Participation Mechanisms for the Environmental Management of Chemicals
Recommendations:
A. Enhance publicity of and communication information concerning the environmental and health risks of chemicals by making information on pollution emissions and environmental monitoring of toxic chemicals publicly available.
B. Establish education programs on the environmental and health risks of toxic chemicals for the general public.
C. Establish public participation mechanisms that provide stakeholders with a platform to participate in government decision-making on chemicals management consistent with international trends.
Abbreviations
Abbreviation Detail
ACS American Chemical Society
BAT/BEP Best Available Techniques and Best Environmental Practice
BHC Benzene Hexachloride
CAAC Civil Aviation Administration of China
CCICED China Council for International Cooperation on Environment and Development
CEC Commission of the European Communities
ChemRTK Chemical Right-to-Know
CMR Carcinogenic, Mutagenic, or Toxic for Reproduction
COD Chemical Oxygen Demand
CRAES Chinese Research Academy of Environmental Sciences
DDT Dichloro-diphenyl-trichloroethane
EC50 Median Effect Concentration
ECB European Chemicals Bureau
EDCs Endocrine Disrupting Chemicals
EIA Environmental Impact Assessment
EPA Environmental Protection Agency of the United States of America
EPA/OPPT Office of Pollution Prevention and Toxics
EPCRA Emergency Planning and Community Right-to-Know Act
GAC General Administration of Customs
GAQSIQ General Administration of Quality Supervision, Inspection and Quarantine
GDP Gross Domestic Product
GHS Globally Harmonized System of Classification and Labeling of Chemicals
GLP Good Laboratory Practice
GTZ Deutsche Gesellschaft für Technische Zusammenarbeit （GmbH）
HCB Hexachlorobenzene
HPV High Production Volume
HPVCs High Production Volume Chemicals
HPVCP HPV Challenge Program
HSDB Hazardous Substances Data Bank
ICCA The International Council of Chemical Associations
IFCS International Forum on Chemical Safety
ILO International Labor Organization
IMOC Inter-Organization Programme for the Sound Management of Chemicals
IPCS The International Programme on Chemical Safety
ITC International Test Commission
IUCLID International Uniform Chemical Information Database
LC50 Median Lethal Concentration
LD50 Median Lethal Dose
MII Ministry of Information Industry
MoA Ministry of Agriculture
MoC Ministry of Communication
MoFA Ministry of Foreign Affairs
MoH Ministry of Health
MoR Ministry of Railways
MoST Ministry of Science and Technology
MPS Ministry of Public Security
MSDS Material Safety Data Sheet
NCG National Coordination Group for Implementation of the Stockholm Convention
NDRC National Development and Reform Commission
NIOSH The National Institute for Occupational Safety and Health
NIP China’s National Implementation Plan for the Stockholm Convention on Persistent Pollutants
NPC National Patent Council
ODS Ozone Depletion Substances
OECD Organization for Economic Cooperation and Development
PBT Persistent Bioaccumulative and Toxic Chemicals
PCBs Polychlorinated Biphenyls
PCE Perchloroethylene
PFOA Perfluorooctanoic Acid
PFOS Perfluorooctane Sulfonate
PIC Prior Informed Consent
POPs Persistent Organic Pollutants
PRTR Pollutant Release and Transfer Register
RC Responsible Care
RCLG Responsible Care Leadership Group
REACH Registration, Evaluation, Authorization and Restriction of Chemicals
RTECS Registry of Toxic Effects of Chemical Substances
SAICM Strategic Approach to International Chemicals Management
SASAC State Asset Supervision and Administration Commission
SAWS State Administration of Work Safety
SBIR Small Business Innovation Research
SEPA State Environmental Protection Administration
SETC State Economic and Trade Committee
SFDA State Food and Drug Administration
SMC Environmentally Sound Management
TBT Technical Barrier to Trade
TCE Trichloroethylene
TRI Toxics Release Inventory
TSCA Toxic Substances Control Act
UNCED United Nation Conference on Environment and Development
VA（s） Voluntary Agreements
VCCEP Voluntary Children's Chemical Evaluation Program
vPvB very Persistent and very Bio-accumulative Chemicals
WHO World Health Organization
WSSD World Summit on Sustainable Development
WTO World Trade Organization
[1] Tuyuqin, China’s pesticide Industry before entering the WTO, World Pesticide, 2001
[2] Feng Shiliang （China Association of Petroleum and Chemical Industry）, the Economic Situation and Outlook on China’s Petroleum and Chemical Sectors in 2005, Economic Analysis on China’s Petroleum and Chemical Industry, 2005
[3] Existing chemical substances means that the substance already include in the name list “inventory of existing chemical substances in China”. The existing chemical substances used to be produced or be imported in China.
[4] “EINECS” means the European Inventory of Existing Commercial Substances. This inventory contains the definite list of all substances deemed to be on the Community market on 18 September 1981, see Article 2 para 1 lit. h）Council Directive 92/32/EEC （OJ L 154 p. 3, 5 June 1992.
[5] For more information please check the Annex.
[6] http://ec.europa.eu/environment/water/water-framework/priority_substances.htm
[7] http://ec.europa.eu/environment/water/water-drink/index_en.html
[8] http://ec.europa.eu/environment/air/index.htm