Registrations for Chemicals Exported to China      

By Zhou Houyun and Ge Xiaojun, CNCIC Chemical HSE Registration Affairs Department

There are considerable laws and regulations related to China's supervision and administration of chemicals today. In terms of international conventions and treaties, they include the "Convention Concerning Safe in the Use of Chemicals at Work" (International Convention No. 170), the "Montreal Protocol on Substances That Deplete the Ozone Layer" (the "Montreal Protocol"), the "Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade" (the "Rotterdam Convention"), the "Stockholm Convention on Persistent Organic Pollutants" (the "Stockholm Convention"), the "Agreement on cooperation in the fight against illicit circulation of narcotic means, psychotropic substances and their precursors" and the "Convention on the Banning of Chemical Weapons". In terms of laws and regulations in the People's Republic of China (PRC), they include the "Production Safety Law of PRC", the "Law of Occupational Disease Prevention of PRC", the "Marine Environmental Protection Law of PRC", the "Law of PRC on Prevention and Control of Water Pollution" (revised in 1996), the "Environmental Protection Law of PRC", the "Law of PRC on the Prevention and Control of Atmospheric Pollution", the "Cleaner Production Promotion Law of PRC", the "Law on Environmental Impact Assessment of PRC", the "Law of PRC on Prevention and Control of Radioactive Pollution", the "Law of PRC on the Prevention and Control of Environmental Pollution by Solid Wastes", the "Regulations on the Administration of Precursor Chemicals" (the State Council's No. 445 Decree), the "Regulations on the Control over Safety of Dangerous Chemicals", the "Regulation for the Labor Protection in Workplaces Where Toxic Substances Are Used", the "Measures for the Administration of Registration of Hazardous Chemicals", the "Measures for the Environmental Administration of New Chemical Substances", the "List of Toxic Chemicals Severely Restricted on Import and Export In PRC" (2007 Edition) and the "Regulation of Environmental Management on the First Import of Chemicals and the Import and Export of Toxic Chemicals" [Revisions (Chapters 9, 10 and 11 were deleted) were made in accordance with the "Decision on Abolishing and Revising Some Regulations and Regulatory Documents" (the State Environmental Protection Administration (SEPA)'s No.41 Decree), the "Decision" started implementation on October 8th, 2007.]and etc. According to these international conventions and China's laws and regulations, registrations and licenses that must be handled for the export of chemicals to China cover the registration for the environmental administration of new chemicals, the license for the supervision and control of chemicals, the Record-keeping or license of Precursor Chemicals and the registration of pesticides. Besides, chemicals used as pharmaceutical raw materials, chemicals used in cosmetics, materials for food packing, antiseptics for drinking water and chemicals used in toys also need to be registered.

Environmental administration registration of
new chemical substances

To strengthen the environmental administration of new chemical substances, prevent environmental pollution, safeguard human health, protect ecological environment and perform commitments to the WTO, China abolished the provisions related to the first import of chemicals in the "Regulation of Environmental Management on the First Import of Chemicals and the Import and Export of Toxic Chemicals" issued in May 1994 and promulgated the "Measures for the Environmental Administration of New Chemical Substances" (the SEPA's No. 17 Decree) on October 15th, 2003. The "Measures" adopts the notification and registration system and the evaluation and license system for new chemical substances commonly used in the international community and also establishes a supervision and administration system in line with the national conditions in China. The objective is to conduct prevention, pre-warning and source control to chemicals and reduce hazards to environment and human health in the circulation of chemicals.

1.   Notification and registration system

The notification and registration system for new chemical substances requests producers or importers of new chemical substances to make the notification of new chemical substances and get the environmental administration registration certification of new chemical substances before production or import. New chemical substances refer to chemical substances that are not included in the "Inventory of Existing Chemical Substances Produced or Imported in China" (the "Inventory of Existing Chemical Substances in China"). Chemical substances that were already produced or imported in China before the promulgation of the "Measures" but have not yet been included in the inventory should be added into the inventory according to the requirements of SEPA, otherwise they would be subject to administration in the way as if they were new chemical substances.

2.   Evaluation and license system

According to the requirements in the "Measures", new chemical substances that have made notification and applied for registration can be produced or imported only after they pass the evaluation made by the evaluation committee and get the license granted by SEPA. SEPA takes charge of establishing the expert evaluation committee and regularly holding evaluation meetings. Evaluation experts should make a scientific judgment on the environmental effect and the health effect of new chemical substances in accordance with the indexes and procedures defined in the "Guidance for the Hazard Evaluation of New Chemical Substances" and on the basis of various data and materials provided by notifiers (including data of physiochemical property, data of toxicology, data of ecotoxicology and lab test results including summaries in Chinese, test reports and qualification certificates of testing organizations; full texts of original literatures if materials are in the form of literatures; comprehensive evaluation to physiochemical hazards, toxicity and ecotoxicology, and MSDS (Material Safety Data Sheet)). The focus is the evaluation made to the intrinsic properties of new chemical substances. Besides, exposure information of new chemical substances should also be taken as reference. An evaluation opinion is formed and submitted by the evaluation committee to SEPA. SEPA then makes the decision on the granting of registration certification.
   The agency in charge of the notification and registration of new chemical substances is the Chemical Registration Center (CRC) of SEPA. In recent years the Chemical HSE Registration Affairs Department of China National Chemical Information Center has done a great deal of work on the pre-evaluation to physiochemical hazards, toxicity and ecotoxicity of new chemical substances before the notification made by notifiers and also prepared MSDS and safety labels according to national standards.
   As new chemical substances have never been produced or imported in China, the evaluation to their environmental impact has to depend more heavily on the test data and exposure information provided by notifiers. The evaluation covers 5 aspects including substance identification, physiochemical property, toxicity, ecotoxicity and safety/environmental