Interpretation of the Key Points of "Registration Measures for Environmental Management of New Chemical Substances"

Release time:

2020-05-09 11:25

On April 29, 2020, the Ministry of Ecology and Environment officially issued the revised 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). The Measures shall 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) issued by the former Ministry of Environmental Protection shall be abolished at the same time.

Compared with the current "Measures" (Order No. 7) and "Guidelines for the Application and Registration of New Chemical Substances", the content of the Measures has been greatly revised. The revisions mainly focus on "focusing on environmental risks, highlighting management and control priorities", "optimizing application requirements, and reducing enterprises" Burden "," Refine registration standards, improve approval requirements "," Strengthen supervision during and after the event, improve management efficiency "," Track new hazard information, continuous prevention of environmental risks.

New Anrun (Beijing) Consulting Co., Ltd. (hereinafter referred to as New Anrun Consulting) compares the current "Measures" (Order No. 7) with the "New Chemical Substances Declaration and Registration Guidelines", and believes that the revision of the "Measures" (Order No. 12) The main content is as follows:

Regarding the specific implementation of the "Measures" Order No. 12, the Ministry of Ecology and Environment has carried out the revision of the "New Chemical Substances Environmental Management Registration Guidelines" and its supporting documents. Further refine and improve the declaration data requirements, hazard assessment, environmental risk assessment, social and economic benefit analysis, new use environmental management registration and other contents involved in the implementation of the Measures, as well as a series of forms and document styles required after registration and registration.

During the change of regulations, Xinanrun Consulting will give corresponding coping strategies for various types of new chemical substances declared under Decree 7 for your reference:

1. Scientific research filing: Because the scientific research filing process is very simple, activities can be carried out only by completing the submission of online materials. If an enterprise has this type of application this year, it is recommended to continue to apply.

2. Simple Declaration-Basic Situation: Considering the implementation of Decree 12, this type of declaration is changed to filing. It is suggested that applicants who have not yet carried out tests can directly file after January 1, 2021.

3. Simple Declaration-Special Situations: Judging from the content of Decree 12, there is no special explanation for the process research and development in simple special circumstances, which may be included in the scope of simple registration in the future. If the enterprise has the need to declare the process research and development, it is recommended to consider completing the declaration this year. However, other cases with simple special circumstances, such as intermediates with a quantity of less than 1 ton, only for export with a quantity of less than 1 ton, scientific research with a quantity of 0.1 to 1 ton, polymers with a monomer content of less than 2% of new chemical substances, or polymers with low concern, will be converted into filing, which is not much different from the current declaration requirements, such as enterprises can proceed normally as required.

4. First-level regular declaration: the change to simple registration under Decree No. 12 reduces the requirements for health toxicology and terrestrial biological toxicity data, and the simple registration certificate obtained under Decree No. 12 will not be included in the Directory. In addition, according to the WTO notification draft, for PB substances should also be submitted to the aquatic environment chronic toxicity test data. Specific data requirements are not specified in Order 12 and should be detailed in the accompanying guidance document. The first-level declaration project, which is planned to be submitted this year, is recommended to be carried out normally, but with follow-up attention to the transitional policy.

5. regular declaration of grade II and above: if considering the long declaration period of this type, basic physical and chemical tests, acute health toxicity, mutagenesis, acute aquatic/terrestrial toxicity and PB determination tests can be carried out first this year. Once the revised guidelines are published, Phase II testing can be conducted directly.

Xinanrun (Beijing) Consulting Co., Ltd. was established in 2009, focusing on chemical regulations and compliance consulting services. With its profound professional technical strength and multi-resource advantages, it is committed to serving pharmaceutical, chemical companies, consumer goods manufacturers, and large multinational companies. The company provides chemical regulations consulting and environmental protection regulations response services. At present, our consulting services on chemical regulations include:

Declaration of new domestic chemical substances
EU-REACH
Registration of hazardous chemicals
SDS/GHS Labeling
South Korea K-REACH Registration
Food contact material declaration
Pharmaceutical, cosmetics regulatory consultation
Environmental regulations consulting services including park environmental protection housekeeper
Design of comprehensive solutions for solid waste and hazardous waste, etc.
If you have chemical registration, environmental compliance issues, please contact us!
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