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New Chemical Substances Environmental Management Practices

Original Language Title: 新化学物质环境管理办法

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(September 12, 2003, the State environmental protection administration released 17th) Chapter I General provisions article in order to strengthen the environmental administration of new chemical substances to prevent pollution, safeguard human health, protecting the environment, developing this approach.
    Article this regulation is applicable in the People's Republic of China territory engaged in the production and import of new chemical substances and environmental management activities.
    Article on the environmental management of production of new chemical substances before and prior notification systems.
    Production or import of new chemical substances must be in accordance with the regulations, prior to the production or import of new chemical substances before declaration, application for a registration certificate for environmental management of new chemical substances (hereinafter registration).
    Before the implementation of these measures has been in the People's Republic of China chemical substances produced or imported in the territory, does not require Declaration of new chemical substances.
    Fourth new chemical substances mentioned in these measures refers to Declaration, not in the People's Republic of China chemical substances produced or imported in the territory.
    SEPA is responsible for collection and announced in due course in the People's Republic of China territory of production or import chemical substances list.
    Fifth the State environmental protection administration responsible for the development of new substances environmental management standards and technical specifications.
    Sixth the State environmental protection administration, the establishment of new chemical substances environmental management review Committee of experts (hereinafter referred to as Committee).
    Review Committee responsible for environmental impact assessment of new chemical substances and written assessments to the State environmental protection administration.
    Article seventh new chemicals management institutions and their staff, for new chemical substances the applicant (hereinafter the applicant) to protect trade secrets and know-how.
    Chapter II Declaration of the eighth applicant prior to production or import to the State environmental protection agency registration Center for chemicals (hereinafter register) returns, of new chemical substances submitted test data report and test qualification data.
    Returns the content declared by including the chemical name of the substance, molecular structures, test methods, use, production or imports, physical – chemical properties, toxicological and eco-toxicological properties, accident prevention and response measures, prevention and elimination of pollution and waste disposal measures.
    Outside China to complete test data, complete test data of foreign testing agencies must be recognized by the national authorities.
    Ecotoxicology data for new chemical substances must be included in the territory of China by China's test of complete test data.
    Nineth declarant in its filings involving trade secrets or know-how require confidential and shall indicate in the application materials.
    When the applicant requested confidentiality of content available to the public, he shall notify the registration center.
    Tenth on the molecular structure similar, uses the same or similar, test new chemical substances with similar data, the applicant may propose series report, by each new chemical substances shall be handled separately to the certificate.
    11th more than two declarations to make joint declarations of the same new chemical substances, separately by each applicant for registration certificates.
    12th has added more than four other States or regional economic integration organization list of existing chemical substances the new chemical substances, reporting only provide returns completed in China and ecological toxicology test report.
    13th article has following case one of of, can application handle from declared procedures: (a) to scientific research for purpose, annual production or imports new chemical material number not over 100 kilograms of; (ii) new chemical material monomer content below 2% of polymer; (three) to for process research, and development and production or imports new chemical material number not over 1000 kilograms of, can application for a years of from declared, not continued;
    (D) in China with China for new chemical substances by biological eco-toxicological testing and test samples of import of new chemical substances.
    Apply for free from formalities of declaration shall be submitted to the register from the Declaration of the application form and related compliance with documentation of the circumstances listed in the first paragraph of this article, and save the materials of scientific research, technological research and development, production or import number, customer name, and other records.
    14th chapter registration register from the date of receipt of the application materials submitted by the applicant in the 15th, in accordance with the measures provide for review in the form of declarations, in conformity with the provisions, admissible and notify the applicant in writing; does not meet the provisions of inadmissibility, and notify the applicant in writing.
    Registration Centre find application materials submitted by the applicant are incomplete or do not meet the requirements of this approach, it should be a one-time written notice to the applicant need to supplement the entire contents.
    Be accepted by the registry, from the date of acceptance of the declarations submitted to the Review Committee in the 5th.
    15th Review Committee within 60 days of the date of receipt of the application materials, according to the State environmental protection administration on the new chemicals management standard and technical specification requirements, an assessment of the environmental effects of chemical substances, and submit the written assessments of State environmental protection administration. 16th State environmental protection agency receiving the Review Committee's written assessment within 30th of the declarations make the decision on whether to register.
    For registration, issuance of registration certificate rejects the registration, giving reasons.
    The State environmental protection administration will notify the registration center by the registration center will notify the applicant in writing.
    17th for processing from the Declaration, register from the date of receipt of the application materials dealing with recommendations within 15th, reported that the State General Administration of environmental protection audit.
    State environmental protection administration, the receipt of the application materials and recommendations from returns on the date 15th decision whether to exempt from filing of the application, and will notify the registration center by the registration center will notify the applicant in writing.
    18th State administration of environmental protection under this article 16th, 17th to be registered or exempt from filing decisions, should be decisions and environmental impact monitoring notification notification of new chemical substances the new chemical producers or importers of provincial environmental protection authorities.
    Provincial environmental protection departments will determine and environmental impact monitoring notification notification of new chemical substances the new chemical producers or importers of local municipal district or County Environmental Protection Department.
    The fourth chapter regulatory registration certificate holder shall, every substantive article 19th production, import or transfer of new chemical substances to users within 5th of, County Department of environmental protection to producers or importers to fill new chemical substance production, import table and flow.
    Producers or importers of the County Department of environmental protection from the date of receipt of the application form in the 5th district, the municipal environmental protection Department, district, the municipal environmental protection authorities, from the date of receipt of the application form submitted to the provincial environmental protection departments in the 5th, the provincial environmental protection authorities, from the date of receipt of the application form within the 5th reported that the State General Administration of environmental protection.
    20th out of production or import of new chemical substances, producers or importers of the County Department of environmental protection from the date of receipt of the application form in the 5th, the flow of new chemical substances should be and the new chemical substances decisions and environmental impact regulatory notice notifies the user the County Environmental Protection Department.
    Use the County Environmental Protection Department since receiving the flow of new chemical substances and chemical substances of the new decision, from the date of notice of environmental impact monitoring in the 5th district, the municipal environmental protection Department, district, the municipal environmental protection authorities, from the date of receipt of the materials submitted to the provincial environmental protection departments in the 5th.
    21st new chemicals registration certificate holder shall be declarations, information such as production or import, of new chemical substance, save to as of the date of the chemicals.
    22nd environmental protection authorities in approving production of new chemical substances or import of new chemical substances used in the production of new construction, renovation or expansion project environmental impact assessment files, whether or not the project should be made to the certificate as an important basis for review.
    23rd environmental protection departments at and above the county level shall supervise and inspect the new chemical substances within their respective administrative regions, found that serious harm to the environment of new chemical substances, shall order the producers, importers and users take immediate emergency measures to eliminate hazards, and remove the drive reported that the State General Administration of environmental protection, and environmental protection authorities at a higher level.
    State environmental protection administration, after receiving the report, verification should be carried out, and you can undo the new chemicals producer or importer's registration certificate.
    24th fifth chapter legal liability for breach of these rules, the applicant in the process of applying for registration fraud, by the State environmental protection administration of China ordered corrective action and fines of between 10,000 yuan and 30,000 yuan, and notice of violations recorded its record and declare inadmissible within three years of its new chemical substances.
    25th article violates these rules, any of the following acts, local environmental protection departments at and above the county level shall be ordered to correct, fined a maximum of 30,000 yuan, and State environmental protection administration reports, violations by the State environmental protection administration bulletin, recorded its record and declare inadmissible within three years of its new chemical substances.
    (A) refused to environmental protection sector site check, or in check Shi fraud of; (ii) not by provides filled new chemical material production, and imports and flows situation record table of; (three) not by provides save new chemical material declared, and production or imports, and new chemical material effect, information of; (four) not declared or not made registration card production or imports new chemical material of.
    26th engaged in environmental management of the new chemicals Agency and his staff have violated these rules, abuse of power, dereliction of duty, or divulge the applicant trade secrets and know-how, shall be given administrative sanctions constitutes a crime, criminal responsibility shall be investigated according to law.
    The sixth chapter supplementary articles article 27th the following file formats and content prescribed by the State environmental protection administration of: (a) the return of new chemical substances, (ii) application form for new chemical substances from the Declaration, (iii) the registration of new chemical substances, (d) notice of environmental impact monitoring of new chemical substances (v) new chemical substance production, import table and flow.
    28th new chemical substance registration fees in accordance with the relevant provisions of the State.
                            29th these measures shall come into force on October 15, 2003.