Measures for Environmental Management of New Chemical Substances

Measures for Environmental Management of New Chemical Substances

Order of State Enviromental Protection Administration[2003] No.2

September 12, 2003

The environmental protection bureaus (departments) of all provinces, autonomous regions, and municipalities directly under the Central Government:

The "Measures for Environmental Management of New Chemical Substances", which were deliberated and adopted at the 4th executive meeting of the State Environmental Protection Administration on April 1, 2003, are hereby promulgated, and shall come into force on October 15, 2003.

Attached: Measures for Environmental Management of New Chemical Substances

Chapter I General Provisions
　
Article 1 These Measures are formulated for the purpose of strengthening the environmental management of new chemical substances, preventing environmental pollution, guaranteeing human health, and protecting the ecological environment.
　
Article 2 These Measures shall apply to the environmental management of new chemical substances produced inside or imported to the Peoples Republic of China.
　
Article 3 The state applies a pre-production and pre-import declaration and registration system to the environmental management of new chemical substances.
Whoever produces or imports a new chemical substance must, in accordance with these Measures, make declaration of the new chemical substance and apply for the registration certificate for environmental management of the new chemical substance (hereinafter referred to as registration certificate) prior to production or import.
With respect to the chemical substances which were produced or imported inside the Peoples Republic of China before these Measures come into force, no declaration of new chemical substances needs to be made.
　
Article 4 New chemical substances as mentioned in these Measures shall mean the chemical substances which have not been produced or imported inside the Peoples Republic of China at the time of declaration.
The State Environmental Protection Administration shall take charge of collecting and timely publishing the name list of the chemical substances which have been produced or imported inside the Peoples Republic of China.
　
Article 5 The State Environmental Protection Administration shall take charge of formulating the standards and technical criteria for environmental management of new chemical substances.
　
Article 6 The State Environmental Protection Administration establishes an expert review committee for environmental management of new chemical substances (hereinafter referred to as the review committee).
The review committee shall take charge of assessing the environmental impact of new chemical substances, and submit written assessment opinions to the State Environmental Protection Administration.
　
Article 7 An institution engaging in environmental management of new chemical substances and its employees shall keep commercial secrets and technical secrets for the materials submitted by the declarers of new chemical substances (hereinafter referred to as the declarers).

Chapter II Declaration

Article 8 A declarer shall, prior to production or import, submit such documents as the declaration form for the new chemical substance, the test data report, and the eligibility testimonial of the test institution to the Chemical Registration Center of the State Environmental Protection Administration (hereinafter referred to as Registration Center).
The contents of a declaration form shall include the name and molecular structure of the declared chemical substance, the test method, its uses, its annual output or import quantity, its physical-chemical nature, toxicological and eco-toxicological features, the measures for prevention of accidents, the emergency responding measures, the methods for prevention and elimination of pollution, and the measures for treatment of wastes, etc.
Where the test data were accomplished outside China, the overseas test institution that accomplished the test data must be accredited by the competent organ of the country where it is located.
The eco-toxicological data of a new chemical substance must include the test data accomplished inside China with Chinese organisms used for test.
　
Article 9 Where a declarer requests for keeping confidential for any commercial secret or technical secret involved in the declaration materials it submits, it shall indicate such a secret in the declaration materials.
The declarer shall, when publicizing the contents required to be kept confidential, inform the Registration Center in writing.
　
Article 10 With respect to the new chemical substances with similar molecular structures, identical or similar uses, or similar test data, the declarer may propose a series of declarations, and separately apply for the registration certificates by each new chemical substance.
　
Article 11 Where two or more declarers make a joint declaration regarding the same new chemical substance, each of them shall apply for and obtain a registration certificate.
　
Article 12 For an new chemical substance which has been listed into the directory of existing chemical substances of four or more other countries or regional economic integration organizations, the declarer only needs to, at the time of declaration, provide the declaration form and the eco-toxicological test report accomplished inside China.

Article 13 In case any of the following circumstances arises, the declarer may apply for exemption from the declaration procedures:
1.
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