The Enlightenment of Foreign New Chemical Substance Declaration and Registration System to China

Keywords: new chemical substance declaration; chemical management; risk assessment
International New Chemical notification Systems and Their Enlightenments to China
CHEN Ji a chao1, ZHOU Bei a hai1, NIE Jing a lei2
(1.Civil & Environmental Engineering School University of Science and Technology Beijing, Beijing 100008; 2.China Registration Center of SEPA , Beijing 100012)
   Abstract: Based on the analysis of the current status of new chemical notification system and characteristic of the developed countries, such as American, EU and Japan, the thesis focused on the comparison of regulations, data requirements of notification, information sharing and new chemical risk assessment to provide enlightenments and advises to build new chemical management system in China. Furthermore, considering the characteristics and disadvantages of our new chemical notification system, we suggest strengthen the environmental regulation system, e.g, reinforce data requirements, research accept non一animal testing data and improve the good laboratory practice (GLP) etc.
   Key words: new chemical notification; chemical management; risk assessment
In order to fulfill the commitment to the management of chemicals after China's accession to the WTO, China canceled the provisions on the registration of the first import of chemicals in the regulations on the administration of the first import of chemicals and the import and export of toxic chemicals on November 1, 2002, on September 12, 2003, the State Environmental Protection Administration issued the "Measures for the Environmental Management of New Chemical Substances" (Order No. 17 of the General Administration) (hereinafter referred to as the "Measures") and began to implement the pre-production or pre-import declaration and registration system for new chemical substances on October 15, 2003. This marks that my country has entered a new era in the field of chemical management. However, there is still a lot of work to be improved and perfected in the implementation of environmental management of new chemical substances. The United States, the European Union, Japan and other developed countries have many years of experience and accumulation in the management of new chemical substances. Through the introduction and comparison of the management scope, test data requirements and risk assessment of the new chemical substance registration system in these developed countries, this paper makes China's chemical industry and enterprises understand the management of new chemical substances abroad, and provides some suggestions for government departments to improve and improve the registration of new chemical substances from the technical aspect.
1 Management of new chemical substances abroad
1.1 American New Chemicals Management
The United States promulgated the Toxic Substances Control Act (TSCA) in 1976, which is a comprehensive law on chemical management. Part 5 requires the implementation of a pre-production declaration review system for new chemical substances, which belongs to market access. The registration of new chemical substances is the responsibility of the Office of Pollution Prevention and Toxic Substances (OPPT) of the US Environmental Protection Agency (EPA). TSCA stipulates that new chemical substances refer to chemical substances that are not listed in the TSCA Existing Chemical Substances List. Substances that have been managed by other regulations, such as drugs, pesticides, radioactive substances, etc., and mixtures, by-products, impurities, non-separated intermediates, articles, etc. that are excluded from TSCA, do not need to be declared [1]. In addition, the scope of the regulation covers the whole process of production, processing, use and disposal of chemical substances, including import and purification.
The regulation of new chemical substances in the United States is characterized by the fact that the pre-production declaration of new chemical substances does not require the submission of test data other than all health and environmental data that are known or reasonably identifiable. Based on these limited data, the EPA must evaluate whether the declared chemical substances cause unusual hazards to human health and ecosystems during production or use. To accomplish this evaluation, EPA has developed exposure assessment methods, databases, and predictive models to assess the hazardous properties of chemicals and their potential release into the environment, and to conduct an initial screening of the environmental impact of chemicals to make a decision on the need for regulatory action on the potential risks of new chemicals [2]. The U.S. Environmental Protection Agency implements component management on the declaration of new chemical substances. For new chemical substances with production or import volume less than or equal to 10 tons/year, only limited data is required and the audit period is only 30 days. However, the applicant is also required to keep records so that the government can carry out TSCA compliance law enforcement inspection. For new chemical substances greater than 10 tons/year, the declaration shall be made 90 days before production, the applicant fills in all health and environmental information and data currently known or reasonably identifiable in accordance with the uniform declaration form (PMN form). In addition, the United States implements classification review on the declaration of new chemical substances, and classifies the declared substances with similar chemical structures into 45 categories for classification review, thus improving the overall work efficiency.
The U.S. government conducts a risk assessment of the declared substance based on the pre-production declaration information submitted by the declarant and the relevant information it already has, raises management concerns about new chemical substances that may cause environmental risks and notifies the declarant, and requires the declarant to implement the pollution prevention measures proposed by the government during the production process [3]. When the data in the declaration and other relevant information available to the government are insufficient to determine whether the substance poses an excessive environmental risk, the EPA may force the applicant to supplement the test data under the GLP framework.
As part of the information in the declaration of new chemical substances represents the high-tech secrets of the declarant. Therefore, under the TSCA requirements, EPA pays special attention to the confidentiality of new chemical substance declaration materials, but does not include the confidentiality of public information such as non-technical and non-commercial. At the same time, TSCA requires the government to disclose this public information and provide conditions for public inquiry.
1.2 New EU Chemical Substance Management
On December 30, 2006, the European Union officially published the legal text of the "Regulations on Registration, Evaluation, Authorization and Restriction of Chemicals" in Volume L396 of the "Official Journal of the European Union", which came into effect on June 1, 2007. REACH aims to improve human health and environmental protection while maintaining the competitiveness of the EU chemical industry and strengthening its innovation capacity. While excluding drugs, pesticides, radioactive substances, etc., the regulations include downstream users of chemicals into the management system, such as textile industry, electronics industry, automobile manufacturing industry, advanced materials and sensory products, and many other downstream chemical industries and enterprises, requiring enterprises to make every effort to prevent and limit the impact on human health and the environment, and choose safe substances. The management of the registration of chemical substances is carried out by the European Chemicals Agency, to be established by the European Commission.
The essence of EU REACH management is the management of chemical substance data, using the principle of early warning. REACH requires filers to provide data with sufficient chemical hazard information and is open to the public. The REACH regulation pays more attention to animal protection, advocates non-animal experiments, and takes measures to research and develop alternative methods of non-animal experiments. At the same time, in the registration process of chemical substances, the management department accepts in vitro toxicological data and QSAR prediction model data, as well as non-GLP system test data in certain fields, such as physical and chemical properties. In order to avoid repeated experiments on vertebrates, it is mandatory for the declarant to share test data using vertebrates [4].
REACH implements phased and non-phased registration on a volume basis, requiring manufacturers/importers of substances greater than 1 ton per year to provide data for registration. Chemical Safety Assessment (CSA) and Chemical Safety Report (CSR) shall also be submitted for substances produced/imported more than 10 tons/year. An important feature of the EU REACH regulation is to bring the enterprises involved in the chemical substance supply chain into the scope of control, and to formulate rules for transmitting information, to ensure communication between upstream and downstream users, and to transfer the responsibility of risk management from the original government to the current declarant. Producers or importers are required to demonstrate the safety of the substances they put on the market, evaluate their use in the context of specific exposures, and propose risk management measures to control the risks of the chemical. The EU REACH regulation stipulates that downstream users are obliged to bear the following five obligations: first, to control risks in strict accordance with the SDS of the safety data sheet; The second is to transmit information along the product supply chain; The third is to submit a written report to the Chemicals Bureau; The fourth is to keep the data updated; The fifth is to inform the upstream of the usage method [5].
Under the REACH regulation, trade secrets are no longer a shield, and not all confidential information requested by enterprises will be approved by the European Chemicals Administration. For some information related to public interest, such as information on the characteristics, ecological toxicity, harmfulness and safe use of chemical substances, "shall not be considered confidential", and the Chemicals Administration shall publish these non-confidential information to the public.
1.3 Japan New Chemical Substance Management
Japan promulgated the Chemical Substances Review and Production Control Act in 1973, which is the first regulation in the world to implement a hazardous prior review system for new chemical substances. The regulation does not control pharmaceuticals, cosmetics, pesticides and other substances regulated by other regulations. The revised regulations in 2004 stipulate that the Ministry of Economy, Industry and Development, the Ministry of the Environment and the Ministry of Health, Labor and Welfare are jointly responsible for the declaration, approval and implementation of control measures for new chemical substances.
Japan's new chemical substance declaration review system is based on the management of hazards. The declaration of new chemical substances shall be carried out according to the quantity. When the total output of the current year is less than 1 ton/year, a small amount of new chemical substances shall be declared. When the total output of the current year is between 1 ton and 10 tons, the declaration of new chemical substances with low output shall be carried out. When declaring new chemical substances with a total output of more than 10 tons in the current year, data of degradation test and ecological toxicity test shall be provided. The law requires that new chemical substances declared more than 1 ton/year should be tested for biodegradation under the GLP framework, and further testing is required based on the biodegradation results. The declaration of new chemical substances in Japan focuses on environmental safety and human health, and does not focus on the assessment of physical hazards [6].
The assessment of chemical substances in Japan is mainly carried out by the Chemical Review Committee organized by the Government of Japan. The Chemical Review Committee has the final approval decision in the review process of new chemical substances, and its members are experts and scholars from various scientific institutions in China. After the assessment of chemical substances, the implementation of classified management, one is to monitor chemical substances, there is evidence that such substances may be harmful to the environment, but the evidence is insufficient; the other is specific chemical substances, there is sufficient evidence that such substances will be harmful to the environment. For other "white" substances with no evidence of harm, no special management is carried out.
The declarant of new chemical substances in Japan is only for enterprises in Japan. For import activities, it must be declared by domestic importers in Japan, and foreign traders have no right to declare.

2 Management status of new chemical substances in China
Environmental management of new chemical substances is a new chemical management work in China. The purpose of establishing a new chemical substance environmental management is preventive management, and strict control of dangerous, toxic, and harmful new chemical substances on the Chinese market is a necessary measure to prevent other countries from using my country as a chemical test site. It reflects "prevention first, prevention and control" The important environmental policy of "combination. Since the implementation of the measures, the environmental management of new chemical substances in China has mainly carried out the following work:
Registration of new chemical substances in 2.1
The normal application materials for new chemical substances involve a large amount of information such as the applicant's information, the name of the declared chemical substance, molecular structure, test method, use, annual production or import volume, physicochemical, toxicological and ecotoxicological properties, accident prevention and emergency measures, pollution prevention and elimination methods, waste disposal measures, etc. Through practice to improve the acceptance of registration procedures, the establishment of internal management measures; through active communication with enterprises, improve work efficiency and play a role in publicity.
2.2 expert review
Review is an essential part of the application and registration. Therefore, when identifying the hazards of new chemical substances, experts in histochemistry, biology, toxicology, environmental science, safety science and other disciplines are needed to identify, analyze and evaluate new chemical substances from multiple angles and different professional fields according to the knowledge and experience of experts and the Guidelines for Hazard Assessment of New Chemical Substances, so as to accurately, scientifically and comprehensively judge the environmental hazards of new chemical substances, propose preventive techniques and management measures, and objectively put forward review opinions for the management department to refer to when making decisions. Through the actual evaluation work, the mode and method of expert evaluation are basically established.
2.3 follow-up supervision and management
The registration of new chemical substances is only a link in the management. It is not only necessary to register and manage new chemical substances, but also to supervise and manage the actual activities of the registered substances. Relying on the local environmental protection bureaus to supervise the registered substances of actual activities, "observe" the impact of these substances on the environment in actual activities, and achieve the ultimate goal of controlling the impact of registered substances on the environment. Tianjin, Shanghai and other local environmental protection bureaus have already carried out some exploratory work in the supervision of new chemical substances.
3 The enlightenment of foreign environmental management experience of new chemical substances to our country.
After years of development and improvement, the management of new chemical substances in the United States, the European Union and Japan has a relatively mature system, relatively standardized technology, relatively specific requirements and different management characteristics. Their new chemical substance management system and experience can give us a lot of enlightenment and reference. We should learn from its advanced management experience, improve the management system of new chemical substances in China according to the national conditions, and maximize the understanding and management of the risks of new chemical substances, in order to minimize their potential harm to humans and the environment.
3.1 clarify the scope of chemical substance management and define new chemical substances
The new chemical substances referred to in the Measures refer to chemical substances that have not been produced or imported in the People's Republic of China at the time of declaration [7]. However, the new chemical substances defined in the Measures cover a wide range and do not specify the scope of chemical substances. Therefore, it is necessary to study and formulate terminology standards and definitions for the management of new chemical substances, and define the scope of substances, so that law enforcers and managed persons can clearly understand the exact meaning of chemical substances in the Measures, so as to better understand and implement the Measures. Provisions.
3.2 improve the types of declaration and refine the data requirements
New chemical substances have many types, wide uses and different forms of existence. At present, China's new chemical substance declaration and registration has not put forward corresponding data requirements for these specific situations, and there is no detailed management of polymers, intermediates and low-level new chemical substances, resulting in inconvenient operation in the specific implementation process [8]. Therefore, the main work to carry out the registration of new chemical substances should start from the aspects of improving the types of declaration, refining and standardizing the data requirements.
3.3 strengthen the use of computer technology, research using non-animal test data
China's current assessment of new chemical substances is mainly determined by new chemical substance evaluation experts according to the test data provided by enterprises. With the development of computer technology, the appeal of animal protectionism and the appeal of reducing the cost of enterprise declaration, QSAR data has been recognized by developed countries. The United States has developed a variety of computer prediction models, and the European Union is also researching and developing non-animal experimental methods. Therefore, we should actively study the role of chemical substance computer prediction model data (QSAR) in risk assessment and management decision-making on the basis of considering the current situation of new chemical substance management, and introduce the use of foreign prediction models to accept non-test data for China's new chemical substance management decision-making.
3.4 Improving the Ability of Testing Institutions and Establishing GLP System
The technical system for the management of new chemical substances is complex and covers a wide range of fields, including the improvement of the "List of Existing Chemical Substances in China" for the identification of new chemical substances, the management of reporting data testing institutions, the update and development of testing methods, and the understanding and evaluation of chemical substances [9]. The testing of new chemical substance declaration data in Europe, the United States, Japan and other countries is required to be carried out under the framework of GLP. However, there is still a gap between the management capacity and construction level of domestic new chemical substance testing laboratories and the GLP international standards. This requires the formulation of laboratory testing standards, the acceleration of laboratory GLP certification, the improvement of laboratory testing quality, and the guarantee of the accuracy and scientificity of chemical testing data, in order to ensure the rationality and scientificity of the registration and management of chemical substances.

References
[1] Richard A. Jordan, Th.D .. TSCA Hand Book Fourth Edition, Government Institutes, 2006:63 ~ 66
[2] David T. Allen, David R. Shaunnard. Green Engineering: Environmental Friendly Chemical Process Design [M]. Beijing: Chemical Industry Press, 2006:55-56
[3] Li Zhengyu. International Chemical Safety Management Strategy [M]. Beijing: Chemical Publishing House, 2005:138~140.
[4] Environment Directorate Organization for Economic Co一operation and Development. Report
of the OECD Workshop on Sharing Information about New Industrial Chemicals Assessment [R].General Distribution OECD/GD (97)33,1997:39~80.
[5] Regulation (EC) No 1907/2006 of the European Parliament and of the Council, Official Journal of the European Union, L 396/1, 30.12.2006:137~162
[6] Ministry of Health, Labor and Welfare, Ministry of Economy, Industry and Industry, Ministry of Environment. Relevant laws (sets of decrees) on the examination and production of chemical substances [G]. March 18, Pingcheng: 1~26.
[7] National Environmental Protection Administration Chemical Registration Center. Compilation of implementation documents of "Environmental Management Measures for New Chemical Substances" [G]. 2006:2~9.
[8] Zhou Hong, Nie Jinglei, Suga Xiaodong. Application of risk assessment in chemical management in China [J]. Environmental Science Research, 2004,17(3): 4~6.
[9] Jian Xiaodong, Nie Jinglei, Shen Yingwa. Application and approval system of new chemical substances and its role in environmental management of chemicals [J]. Environmental Science Research, 2004,17(3): 10~12.
About the author: Chen Jichao, male, master student of the School of Civil and Environmental Engineering, University of Science and Technology Beijing; Zhou Beihai, male, doctor, professor, mainly engaged in environmental engineering, environmental science, environmental analysis and monitoring, biochemical research.