Measures for Environmental Management of New Chemical Substances (2010 Revision)

Measures for Environmental Management of New Chemical Substances (2010 Revision) Order of the Ministry of Environmental Protection (No. 7) The Measures for Environmental Management of New Chemical Substances, which were revised and adopted at the 3rd executive meeting of the Ministry of Environmental Protection on December 30, 2009, are hereby promulgated and shall come into force on October 15, 2010. The Measures for Environmental Management of New Chemical Substances promulgated by the former State Environmental Protection Administration on September 12, 2003 shall be abolished simultaneously. Minster of the Ministry of Environmental Protection Zhou Shengxian January 19, 2010 Measures for Environmental Management of New Chemical Substances Chapter I General Provisions Chapter II Notification Procedures Chapter III Registration Management Chapter IV Follow-up Control Chapter V Legal Liabilities Chapter VI Supplementary Provisions Chapter I General Provisions Article 1 (Legislative Purpose) These Measures are formulated in accordance with the Decision of the State Council on Establishing Administrative Licenses for the Administrative Examination and Approval Items Really Necessary to Be Retained and other relevant laws and administrative regulations for purposes of controlling environmental risks of new chemical substances, guaranteeing human health, and protecting the ecological environment. Article 2 (Scope of application) These Measures shall apply to the environmental management of the activities in relation to the research, production, import, processing and use of new chemical substances within the territory of the People's Republic of China. The environmental management of the activities in relation to new chemical substances in the bonded areas and export processing areas shall also be governed by these Measures. The management of pharmaceuticals, pesticides, veterinary medicines, cosmetics, food, food addictive, feed addictive, etc. shall be governed by the relevant laws and regulations. However, the environmental management of the activities related to new chemical substances used as raw materials and intermediates of the aforesaid products shall be governed by these Measures. The articles which are designed to intentionally release contained new chemical substances in their normal use shall be governed by these Measures. Article 3 (Classification) New chemical substances shall be categorized into general new chemical substances and hazardous new chemical substances according to the standards for identification and classification of hazardous properties of chemicals. Hazardous new chemical substances that are persistent, bio-accumulative, and hazardous to ecological environment or human physical health shall be classified as hazardous new chemical substances of priority environmental management. The term “new chemical substances” as mentioned in these Measures refers to chemical substances that are not listed in the Inventory of Existing Chemical Substances in China. The Inventory of Existing Chemical Substances in China is formulated, adjusted and published by the Ministry of Environmental Protection. Article 4 (Basic System) The State shall conduct classified management of risks of new chemical substances, and implement the systems of notification and registration and follow-up control thereon. Article 5 (Registration Certificate) A producer or importer of a new chemical substance must submit a notification of the new chemical substance and obtain the registration certificate for environmental management of the new chemical substance (hereinafter referred to as “registration certificate”) prior to production or import. A new chemical substance without registration certificate shall be prohibited from being produced, imported, processed or used. A new chemical substance without registration certificate or failed to be filed and notified shall be prohibited from being used for scientific research. Article 6 (Encouraging Advanced Technology) The State shall support the scientific research on the technologies of assessment and control of environmental and health risks from new chemical substances, promote advanced applicable technologies for controlling environmental risks of new chemical substances, support the research, production, import, processing and use of environment-friendly alternates to chemical substances, and encourage the notifiers to share notification and registration data of new chemical substances. Article 7 (Confidentiality) The staff members engaged in environmental management of new chemical substances shall keep confidential the business secrets and technical secrets for the notifiers. Article 8 (Public Supervision) All entities and individuals are entitled to disclose, report and impeach the violations of these Measures. Chapter II Notification Procedures Article 9 (Types of Notification) The notification of new chemical substances shall be classified into regular notification, simplified notification and scientific research filing notification. Article 10 (Requirements for Regular Notification) Where the annual production or import volume of a new chemical substance is at or above one metric ton, the producer or importer shall submit a notification report on new chemical substances to the Chemical Registration Center of the Ministry of Environmental Protection (hereinafter referred to as “Registration Center”) prior to production and import for going through the regular notification; however, if it meets the conditions for simplified notification, simplified notification shall be gone through. A notification report on new chemical substances shall include the following contents: (1) A regular notification form for new chemical substances, attached with classification and labels and msds conducted according to the safety rules for classification, precautionary labeling and precautionary statements of chemicals and other relevant national standards; (2) a risk assessment report, including hazard assessment of the notified substance, exposure scenarios assessment and risk control measures, assessment results of environment and health risks, etc.; and (3) a test report or materials of the substance's physicochemical properties and toxicological and eco-toxicological properties, and the eligibility testimonial of the relevant testing institutions. The eco-toxicological testing report must include the data of test conducted on a Chinese test species within the territory of China according to the relevant standards. Article 11 (Quantity Grades of Regular Notification) A regular notification shall follow the principle of “the higher the quantity grade of notification, the stricter the requirements for test data”. The notifier shall, according to the guide for notification and registration of new chemical substances formulated by the Ministry of Environmental Protection, provide corresponding test data or materials. The regular notification is classified into four grades in an ascending sequence as follows according to the notified quantity of new chemical substances: (1) Grade 1: the new chemical substance produced or imported is more than 1 metric ton but less than 10 metric tons per annum; (2) Grade 2: the new chemical substance produced or imported is more than 10 metric tons but less than 100 metric tons per annum; (3) Grade 3: the new chemical substance produced or imported is more than 100 metric tons but less than 1,000 metric tons per annum; and (4) Grade 4: the new chemical substance produced or imported is more than 1,000 metric tons per annum. Article 12 (Basic Circumstances for Simplified Notification) Where a new chemical substance produced or imported is less than 1 metric ton per annum, the producer or importer shall make a simplified notification to the Registration Center prior to production or import. To make a simplified notification, the following materials shall be submitted: (1) a simplified notification form for the new chemical substance; and (2) a report on eco-toxicological testing conducted on Chinese test species within the territory of China. Article 13 (Special Circumstances for Simplified Notification) Where a new chemical substance produced or imported falls under any of the following circumstances, a simplified notification shall be made: (1) the new chemical substance is used as an intermediate or only for export with an annual production or import volume of less than 1 metric ton; (2) the new chemical substance is used for the purpose of scientific research with an annual production or import volume of more than 0.1 metric ton but less than 1 metric ton; (3) the new chemical substance is a polymer with a monomer concentration less than 2% or a low concern polymer; or (4) the new chemical substance is used for purposes of technics and product research and development with an annual production or import volume of less than 10 metric tons over a period of not more than two years. To make a simplified notification for special circumstances, a simplified notification form for new chemical substance and the certification materials in line with the circumstances shall be submitted. Article 14 (Requirements for Filing Notification) Under any of the following circumstances, a producer or importer shall, prior to production or import, submit a scientific research filing form for new chemical substances to the Registration Center to handle the scientific research filing notification: (1) the new chemical substance is used for the purpose of scientific research with an annual production or import volume of less than 0.1 metric ton; or (2) importing test samples of new chemical substances in order to conduct tests of eco-toxicological properties of new chemical substances on Chinese test species within the territory of China. Article 15 (Serial, Joint and Repeated Notifications) When making a regular notification, under any of the following circumstances, the notifier may go through the formalities for notification according to the following provisions: (1) With respect to several new chemical substances with similar molecular structures, identical or similar uses, or similar test data, the same notifier may propose a serial notification of new chemical substances; (2) Where two or more notifiers make notifications of the same new chemical substance simultaneously, and submit notification materials jointly, they may make a joint notification of the new chemical substance; or (3) Where two or more notifiers make notifications for the same new chemical substance successively, and the latter notifier uses the test data of the former notifier upon approval thereof, it may submit a repeated notification of new chemical substance. The sharing method of the cost of data testing shall be negotiated by the notifiers themselves. Article 16 (Qualification of Notifiers) The notifier or agent thereof of a new chemical substance shall be an institution registered in China. Those submitting notifications of new chemical substances not for the first time must not have a bad record of administrative punishment for violation of the provisions on environmental management of new chemical substances in recent three years. Article 17 (Truthful Reporting) A notifier shall, when going through the formalities for notification of a new chemical substance, truthfully submit all known information regarding hazardous properties and environmental risks of the new chemical substance. Article 18 (Disclosure of Environmental Information) Where a notifier makes a request for keeping confidential any business secret or technical secret involved in the notification materials it......