Notice on the convergence matters related to the environmental management registration of new chemical substances (draft for comments)

Release time:

2020-06-04 09:26

Notice on matters related to the registration of environmental management of new chemical substances

(Exposure Draft)

The Measures for the Registration of Environmental Management of New Chemical Substances (Order No. 12 of the Ministry of Ecology and Environment, hereinafter referred to as the Measures) will come into force on January 1, 2021, and the Measures for the Environmental Management of New Chemical Substances (Order No. 7 of the Ministry of Environmental Protection, hereinafter referred to as Order No. 7) issued by the former Ministry of Environmental Protection on January 19, 2010 shall be abolished at the same time. In order to ensure the orderly continuation of the environmental management registration of new chemical substances, the relevant convergence matters are hereby notified as follows:

1. from the effective date of the Measures, new chemical substances that have obtained the registration certificate of the environmental management regular for new chemical substances in accordance with Order No. 7 shall be included in the List of Existing Chemical Substances in China:

The holder of the (I) registration certificate and the corresponding processing user shall take environmental risk control measures in accordance with the provisions of the registration certificate.

The holder of the (II) registration certificate shall, in accordance with the provisions of articles 38, 39, 41 and 42 of the measures, carry out information transmission, data recording and preservation, first activity report and new hazard information report; among them, if it belongs to the key environmental management hazardous new chemical substances specified in Article 3 of Decree No. 7, it shall also submit an annual report in accordance with the provisions of Article 41 of the measures.

The holder of the (III) registration certificate may, in accordance with the provisions of Article 33 of the measures, apply to the competent department of ecological environment under the State Council for cancellation of the registration certificate.

In accordance with the key environmental management hazardous new chemical substances identified in Order No. 7, the (IV) continues to implement environmental management registration for new uses, and stipulates permitted uses when they are included in the "List of Existing Chemical Substances in China.

If the holder of the (V) registration certificate intends to change the information contained in the registration certificate, he shall re-apply for registration in accordance with the relevant provisions of the "Measures" and obtain a new chemical substance environmental management registration certificate.

2. from the effective date of the Measures, new chemical substances that have obtained the simple declaration and registration certificate for the environmental management of new chemical substances in accordance with Order No. 7:

The holder of the (I) registration certificate shall record and preserve the information in accordance with the provisions of Article 39 of the Measures.

The holder of the (II) registration certificate may, in accordance with the provisions of Article 33 of the measures, apply to the competent department of ecological environment under the State Council for cancellation of the registration certificate.

The validity period of the simple declaration and registration certificate for (III) process and product research and development is two years after the first activity.

If the holder of the (IV) registration certificate intends to change the information contained in the registration certificate, he shall, in accordance with the relevant provisions of the measures, go through the filing of the environmental management of new chemical substances, or apply for registration again, and obtain the registration certificate of environmental management of new chemical substances.

3. the new chemical substances that have obtained the new chemical substance environmental management registration certificate in accordance with Order No. 7 and meet the requirements of Article 35 of the Measures, the competent department of ecological environment under the State Council may revoke the registration certificate in accordance with the relevant provisions of the the People's Republic of China Administrative Licensing Law.

4. the new chemical substance environmental management registration application that has been accepted before the entry into force of the Measures, if the application materials do not meet the requirements or the normal approval process cannot be completed within the processing time limit, etc., the registration certificate cannot be obtained before the Measures take effect. It shall apply for registration of new chemical substance environmental management in accordance with the relevant provisions of the "Measures.

Drafting Notes on the Notice on the Linkage Matters Related to the Environmental Management Registration of New Chemical Substances (Draft for Solicitation of Comments)

China issued the measures for the Environmental Management of New Chemical substances in 2003 (decree No. 17 of the State Environmental Protection Administration, hereinafter referred to as decree No. 17), which was revised for the first time in 2010 and issued the measures for the Environmental Management of New Chemical substances (decree No. 7 of the Ministry of Environmental Protection, hereinafter referred to as decree No. 7). The second revision was made in 2020. The newly revised "New Chemical Substances Environmental Management Registration Measures" (Order No. 12 of the Ministry of Ecology and Environment, hereinafter referred to as the "Measures") was issued on April 29, 2020 and will be implemented from January 1, 2021. In order to ensure the smooth implementation of the "Measures" and the smooth transition and connection with Order No. 7, the Ministry of Ecology and Environment organized the drafting of the "Notice on the Connection Matters Related to the Registration of the Environmental Management of New Chemical Substances" (draft for comments), which stipulates the relevant connection matters.

1. formulation basis

According to the "the People's Republic of China Administrative Licensing Law", in accordance with the relevant provisions of the "Measures" and Order No. 7, formulate the connection matters related to the environmental management registration of new chemical substances.

2. Necessity

Article 53 of the measures stipulates that if the environmental management registration of new chemical substances has been completed in accordance with the provisions of orders No. 7 and No. 17, the relevant registration shall continue to be valid after the implementation of the measures. Article 55 stipulates that the "Measures" shall come into force on January 1, 2021, and Order No. 7 issued by the former Ministry of Environmental Protection shall be repealed at the same time.

The overall convergence policies and principles between the "Measures" and Order No. 7 have been stipulated in principle in the "Measures", but because the convergence involves more details and specific issues, the situation is more complicated, and it is necessary to clarify specific matters in the form of normative documents.

3. drafting process

In the process of revising the measures, the Ministry of Ecology and Environment organized a simultaneous study on the convergence matters related to the implementation of the measures, systematically analyzed and compared the relevant provisions of orders 7 and 17 one by one, and fully considered the various specific situations and solutions of the convergence between the measures and order 7, on the basis of conforming to the basic principles of the the People's Republic of China Administrative Licensing Law and the applicable rules of "from the old and from the light, based on the principles of problem solving, continuous stability, convenience for enterprises, and prevention of environmental risks, after repeated demonstrations, the" Notice on the Connection Matters of the Environmental Management Registration of New Chemical Substances "(draft for comments) was formed.

Main contents of 4.

In accordance with the principles of "from the old to the lighter" and risk prevention and continuous stability, the (I) has stipulated the convergence policies for the continuation of some registration and management requirements stipulated in Decree 7, such as environmental risk control, information transmission, data recording and preservation, first activity report, new hazard information report, annual report, application for cancellation of registration, validity period of registration certificate and environmental management registration for new uses.

(II), in accordance with the administrative license examination and approval standards and time limit requirements, for applications that have been accepted when the Measures came into effect, but have not made an examination and approval decision due to reasons such as the application materials do not meet the requirements or the normal examination and approval process cannot be completed within the processing time limit, the convergence policy for applying for environmental management registration of new chemical substances in accordance with the relevant provisions of the Measures has been stipulated.

(III) consideration is given to optimizing, simplifying and facilitating enterprises. For those who intend to change the registration certificate obtained under Decree No. 7, a convenient convergence policy is stipulated. For example, if the simple registration certificate obtained according to Decree No. 7 and the information contained in the registration certificate to be changed, the registration certificate shall be filed or re-applied for registration in accordance with the relevant provisions of the Measures.

No need to submit paper materials for registration of hazardous chemicals

The "New Chemical Substance Environmental Management Registration Measures" will be implemented from January 1, 2021!

No need to submit paper materials for registration of hazardous chemicals

The "New Chemical Substance Environmental Management Registration Measures" will be implemented from January 1, 2021!

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