Measures for the Environmental Management of New Chemical Substances
Measures for the Environmental Management of New Chemical Substances
Measures for the Environmental Management of New Chemical Substances
Order of the Ministry of Environmental Protection No. 7
January 19, 2010
The "Measures for the Environmental Management of New Chemical Substances", which were amended and adopted at the 3rd executive meeting of Ministry of Environmental Protection on December 30, 2009, are hereby promulgated and shall come into force as of October 15, 2010.
The Measures for the Environmental Management of New Chemical Substances promulgated by the former State Environmental Protection Administration on September 12, 2003 shall be repealed at the same time.
Minister of Ministry of Environmental Protection: Zhou Shengxian
Measures for the Environmental Management of New Chemical Substances
Chapter I General Provisions
Chapter II Declaration Procedures
Chapter III Registration Administration
Chapter IV Follow-up Control
Chapter V Legal Responsibilities
Chapter VI Supplementary Provisions
Chapter I General Provisions
Article 1 [Purpose of legislation] With a view to controlling the environmental hazards of new chemical substances, safeguarding human health and protecting ecological environment, these Measures are formulated in accordance with Decision of the State Council on Applying Administrative Licensing to the Administrative Examination and Approval Items Really Necessary to Be Retained as well as other relevant laws and administrative regulations.
Article 2 [Applicable Scope] These Measures shall apply to the environmental management in 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 activities relevant to new chemical substances within bonded zones and export processing zones shall also be governed by these Measures.
The management of medicine, pesticide, veterinary medicine, cosmetics, food, food additives, and feed additives shall be governed by relevant laws and regulations; however, the environmental management of activities relevant to new chemical substances as the material or intermediate of afore-mentioned products shall be governed by these Measures.
The articles that are designed to intentionally release new chemical substances contained therein in routine use shall be governed in accordance with these Measures.
Article 3 [Classification] In light of the identification and classification standards for hazardous properties of chemicals, new chemical substances may be classified into ordinary new chemical substances and hazardous new chemical substances.
The hazardous new chemical substances that have persistent effects and biological accumulation and that are hazardous to ecological environment and human health shall be listed as the hazardous new chemical substances under key environmental management.
For the purposes of these Measures, the new chemical substances shall mean the 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 promulgated by Ministry of Environmental Protection.
Article 4 [Basic System] The State administers new chemical substances based on the hazard categories and practices a declaration registration and follow-up control system for such substances.
Article 5 [Registration Certificate] The producer or importer of new chemical substances shall make a declaration thereon before the production or import thereof and obtain the registration certificate for environmental management of new chemical substances (hereinafter referred to as "Registration Certificate").
The production, import, processing and use of new chemical substances for which Registration Certificate has been not obtained shall be prohibited.
The new chemical substances with regard to which the Registration Certificate has not been obtained or the filing declaration has been made may not be used in scientific research.
Article 6 [Encouraging the Development of Advanced Technologies] The State supports scientific research in appraisal and control techniques of environmental hazards and health hazards of new chemical substances, promotes advanced and applicable environmental hazard control technologies of new chemical substances, encourages the research, production, import, processing and use of environment-friendly chemical substitutes, and encourages declarers to share declaration registration data of new chemical substances.
Article 7 [Confidentiality] The personnel engaged in environmental management of new chemical substances shall keep confidential the business secrets and technological secrets for the declarers.
Article 8 [Public Supervision] All entities and individuals shall have the right to disclose, report and incriminate any acts or omissions in violation of these Provisions.
Chapter II Declaration Procedures
Article 9 [Declaration Types] The declaration of new chemical substances shall be classified into regular declaration, summary declaration and scientific research filing declaration.
Article 10 [Requirements for Regular Declaration] The declarer with its annual yielding capacity or import volume of new chemical substances exceeding 1 ton shall, before the production or import of such substances, submit a declaration report on such new chemical substances to the chemical Registration Center under Ministry of Environmental Protection (hereinafter referred to as the "Registration Center") and go through regular declaration procedures; however, the declarers that conform to the requirements for summary declaration may go through summary declaration directly.
The declaration report on new chemical substances shall include the following contents:
1. Regular declaration form for new chemical substances, which shall be attached with the classification, label, and chemical safety data sheet conducted in light of the classification, precautionary labels, precautionary statements of chemicals and other relevant standards of the State;
2. Hazard assessment report, including hazard assessment, exposure forecast assessment and hazard control measures of declared substances as well as assessment conclusions on environmental hazard and health hazard, etc.; and
3. Test report or information on the physicochemical property, toxicological and eco-toxicological properties as well as the qualification certificate of relevant testing organizations. The test report on eco-toxicological properties must include the test data accomplished inside China with Chinese organisms used for test in light of relevant standards.
Article 11 [Quantity Level of Regular Declaration] The regular declaration shall follow the principle of "the higher the declaration quantity level, the higher the requirement for test data". The declarer shall provide corresponding test data or information according to the guidelines for declaration registration of new chemical substances formulated by Ministry of Environmental Protection.
The regular declaration shall be divided into the following four grades from the lowest to the highest in light of the declaration quantity of new chemical substances:
1. The annual yielding capacity or import volume of more than 1 ton but less than 10 tons shall fall within the first grade;
2. The annual yielding capacity or import volume of more than 10 tons but less than 100 tons shall fall within the second grade;
3. The annual yielding capacity or import volume of more than 100 tons but less than 1000 tons shall fall within the third grade; and
4. The annual yielding capacity or import volume of more than 1000 tons shall fall within the fourth grade.
Article 12 [Basic Circumstance of Summary Declaration] The declarer with an annual yielding capacity or import volume of new chemical substances of less than 1 ton shall go through summary declaration with the Registration Center before production or import of such new chemical substances.
To apply for the summary declaration, the following materials shall be submitted:
1.
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