Measures for the Environmental Management Registration of New Chemical Substances

Measures for the Environmental Management Registration of New Chemical Substances Order of the Ministry of Ecology and Environment (No. 12) The Measures for the Environmental Management Registration of New Chemical Substances, as deliberated and adopted at the executive meeting of the Ministry of Ecology and Environment on February 17, 2020, are hereby issued and shall come into force on January 1, 2021, upon which the Measures for the Environmental Management of New Chemical Substances (Order No. 7, Ministry of Environmental Protection) issued by the former Ministry of Environmental Protection on January 19, 2010, shall be repealed. Huang Runqiu, Minister of Ecology and Environment April 29, 2020 Measures for the Environmental Management Registration of New Chemical Substances Chapter I General Provisions Article 1 For the purposes of regulating the environmental management registration of new chemical substances, assessing, managing and controlling the environmental risks of new chemical substances in a scientific and effective manner, focusing on the new chemical substances that may pose great risks to environment and health, protecting ecology and environment, and safeguarding public health, these Measures are developed in accordance with relevant laws and regulations and the Decision of the State Council to Establish Administrative Licensing for the Administrative Approval Items Really Necessary to Be Retained. Article 2 These Measures shall apply to the environmental management registration of the research, production, import, and processing or use of new chemical substances within the territory of the People's Republic of China, except for the new chemical substances that are stored in the areas under special customs supervision after import and are all exported without any processing. These Measures shall not apply to the following products or substances: (1) Pharmaceuticals, pesticides, veterinary medicines, cosmetics, food, food addictives, feed, feed addictives, fertilizers and other products, except for the new industrial substances that change to be used for other industrial purposes and the new industrial substances used as the raw materials and intermediates of the above products. (2) Radioactive substances. The new chemical substances contained in the articles which are designed to intentionally release such new chemical substances during their normal use shall be governed by these Measures. Article 3 For the purpose of these Measures, “new chemical substances” means the chemical substances that are not listed in the Inventory of Existing Chemical Substances in China. The chemical substances that have been listed in the Inventory of Existing Chemical Substances in China shall be subject to environmental management as existing chemical substances. However, where the chemical substances which shall be subject to new-use environmental management according to the Inventory of Existing Chemical Substances in China are used for industrial purposes other than allowed ones, they shall be subject to environmental management as new chemical substances. The Inventory of Existing Chemical Substances in China shall be developed, adjusted and published by the ecology and environment department of the State Council, including the chemical substances that have been produced, sold, processed or used, or imported within the territory of the People's Republic of China before October 15, 2003, and the chemical substances listed according to the relevant provisions on the environmental management of new chemical substances after October 15, 2003. Article 4 The state implements the environmental management registration system for new chemical substances. The environmental management registration of new chemical substances shall be classified into routine registration, simplified registration and recordation. The producers or importers of new chemical substances shall obtain routine registration certificates or simplified registration certificates for the environmental management of new chemical substances (hereinafter referred to as “registration certificates”) or undergo the recordation formalities for the environmental management of new chemical substances before production or import. Article 5 The environmental management registration of new chemical substances shall follow the principles of scientificity, efficiency, openness, fairness, impartiality and facilitating the people, adhere to access administration from the source, risk prevention, and classified management, and put emphasis on the management and control of the new chemical substances which are persistent, bioaccumulative and severely hazardous to environment or health, or may exist for a long time in the environment and may pose large risks to environment and health. Article 6 The ecology and environment department of the State Council shall take charge of organizing the national environmental management registration of new chemical substances, developing the relevant policies, technical specifications and guidelines for the environmental management registration of new chemical substances and other supporting documents as well as registration review rules, and strengthening the information technology construction for the environmental management registration of new chemical substances. The ecology and environment department of the State Council shall organize the formation of an expert committee for the environmental risk assessment of chemical substances (hereinafter referred to as the “expert committee”). The expert committee shall be composed of experts in terms of chemistry, chemical engineering, health, environment and economy, among others, and provide technical support for the review of the environmental management registration of new chemical substances. The local ecology and environment departments at or above the districted city level shall take charge of conducting environmental supervision and administration of the implementation of these Measures by relevant enterprises and public institutions that research, produce, import, and process or use new chemical substances within these administrative regions. The technical institutions for the environmental management of chemical substances subordinate to the ecology and environment department of the State Council shall participate in the review of the environmental management registration of new chemical substances, and undertake the specific work concerning the environmental management registration of new chemical substances. Article 7 Enterprises and public institutions engaging in the research, production, import, and processing or use of new chemical substances shall abide by the provisions of these Measures, take effective measures to prevent and control the environmental risks of new chemical substances, and assume liabilities for the damages caused by such new chemical substances according to the law. Article 8 The state encourages and supports the scientific research, promotion and application of technologies for the environmental risk assessment and control of new chemical substances, and encourages the research and application of eco-friendly chemical substances and related technologies. Article 9 All entities and individuals have the right to report violations of these Measures to ecology and environment departments. Chapter II Basic Requirements Articl 10 Where the annual production or import volume of any new chemical substances is more than ten tons, the formalities for the routine environmental management registration of the new chemical substance (hereinafter referred to as “routine registration”) shall be undergone. Where the annual production or import volume of any new chemical substance is not less than one ton nor more than ten tons, the formalities for the simplified environmental management registration of the new chemical substance (hereinafter referred to as “simplified registration”) shall be undergone. Where a new chemical substance meets any of the following conditions, the formalities for the environmental management recordation of the new chemical substance (hereinafter referred to as “recordation”) shall be undergone: (1) The annual production or import volume of the new chemical substance is less than one ton. (2) The new chemical substance is a polymer with the monomer or reactant content of less than 2% or a polymer of low concern. Article 11 Applicants for the environmental management registration of new chemical substances shall be enterprises and public institutions engaging in the production or import of new chemical substances which are legally registered within the territory of the People's Republic of China and can independently bear legal liability. The production or trade enterprises that intend to export new chemical substances to the territory of the People's Republic of China may also be applicants, but they shall designate enterprises or public institutions that are legally registered within the territory of the People's Republic of China and can independently bear legal liability to act as their agents to jointly perform the obligations of the environmental management registration of new chemical substances and the environmental management after registration, and assume liabilities according to the law. Where the pharmaceuticals, pesticides, veterinary medicines, cosmetics, food, food addictives, feed, feed addictives, fertilizers and other products as set forth in Article 2 of these Measures are within the scope of new chemical substances, and are to be used for other industrial purposes, the producers, importers or processors or users of relevant products may be applicants. If a chemical substance that has been listed in the Inventory of Existing Chemical Substances in China and is subject to the new-use environmental management is to be used for any industrial purpose other than allowed purposes, any of the producer, importer, and processor or user of the relevant chemical substance may be the applicant. Article 12 An applicant for the environmental management registration of a new chemical substance shall submit the registration application or recordation materials to the ecology and environment department of the State Council, and be responsible for the authenticity, completeness, accuracy and legality of the registration application or recordation materials. The state encourages applicants to share data on the environmental management registration of new chemical substances. Article 13 Applicants considering that the registration application or recordation materials they submit involve trade secrets and requiring information protection shall put forward the requirement when applying for registration or undergoing recordation formalities, and submit the materials explaining the necessary of applying for trade secret protection. The ecology and environment department of the State Council is allowed not to provide trade secret protection for the information that may pose a significant impact on environment or public health benefits according to the law. Applicants may withdraw in writing the information protection requests they have made. The protection period for the name and other labeling information of a new chemical substance shall be not more than five years from the date of initial registration or recordation. The staff members and relevant experts engaging in the environmental management registration of new chemical substances shall not disclose the commercial secrets that shall be protected according to the law. Article 14 The testing institutions within the territory of the People's Republic of China that provide test data for the environmental management registration of new chemical substances shall be accredited as inspection and testing institutions according to the law, and conduct testing in strict accordance with the relevant standards for chemical substance testing; and health toxicology and ecotoxicology testing institutions shall also conform to good laboratory management practices. Testing institutions shall be responsible for the authenticity and reliability of the testing results issued by them, and shall assume responsibilities according to the law. The ecology and environment department of the State Council shall organize the supervision and random inspections of the testing conducted by and conditions for chemical substance ecotoxicology testing institutions. The overseas testing institutions of the People's Republic of China that issue health toxicology or ecotoxicology test data shall meet the internationally accepted good laboratory management requirements. Chapter III Routine Registration, Simplified Registration and Recordation Section 1 Application for and acceptance of routine registration and simplified registration Article 15 An applicant for routine registration shall submit the following materials: (1) Application form for routine registration. (2) A test report or materials on physicochemical properties and health toxicological and eco-toxicological properties of the new chemical substance. (3) Environmental risk assessment report on the new chemical substance, including assessment of environmental risks possibly caused by the new chemical substance to be registered upon request, analysis of the environmental risk control measures to the taken and their appropriateness, and whether the assessment conclusion that there are unreasonable environmental risks is made. (4) A letter of commitment to implementing or transmitting environmental risk control measures and environmental management requirements, which shall be signed by the legal representative of the enterprise or public institution or the person authorized by it, and to which the official seal shall be affixed. The relevant test report and materials as prescribed in subparagraph (2) in the preceding paragraph shall meet the needs of the environmental risk assessment of the new chemical substance; and the ecotoxicology test report shall include the data on the test completed on the test organisms of the People's Republic of China in accordance with the relevant standards. As for a highly hazardous chemical substance, the applicant shall also submit the analysis materials for the social and economic benefits of the activities in relation to the new chemical substance, including explanations of whether the new chemical substance has a considerable or obvious advantage over the chemical substance in use which has the same uses in terms of performance and environmental friendliness, among others, to fully demonstrate the necessity of the application activity. In addition to the application materials as prescribed in the first three paragraphs of this article, the applicant shall also submit other information on the environmental and health hazard properties and environmental risks of the new chemical substance it has obtained. Article 16 An applicant for simplified registration shall submit the following materials: (1) An application form for simplified registration. (2) The physicochemical properties of the new chemical substance, as well as persistence, bioaccumulation, aquatic environmental toxicity and other ecotoxicology test reports or materials. (3) A letter of commitment to implementing or transmitting environmental risk control measures, which shall be signed by the legal representative of the enterprise or public institution or the person authorized by it and to which the official seal shall be affixed. The ecotoxicology test reports as prescribed in the subparagraph (2) of the preceding paragraph shall include the data on the test conducted on the test species of the People's Republic of China according to the relevant standards. In addition to the application materials as prescribed in the preceding paragraph, the applicant shall also submit other inform......