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Regular registration of new chemical substances
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). After the formal promulgation and implementation of the measures, people from all walks of life have paid great attention to the detailed rules for its implementation.
On August 17, the Ministry of Ecology and Environment finally issued the "Guidelines for the Registration of Environmental Management of New Chemical Substances (Draft for Comment)" (hereinafter referred to as the "Guidelines"), and publicly solicited opinions. The deadline for soliciting opinions is September 6, 2020.
The guide is a supporting normative document for the implementation of the measures, which refines the relevant provisions of the measures and defines the specific implementation requirements. This guide mainly includes registration scope, registration type, registration procedure, registration application material requirements, polymer special provisions and new use environmental management registration, re-registration, registration certificate change, withdrawal and cancellation, and post-registration tracking management.
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Registration scope
Clear raw materials, pesticides, not applicable to the Measures.
Chemical substances that have been listed in the Directory and are subject to environmental management for new uses, and are used for industrial uses other than permitted uses, are required to be registered;
Medicines (including raw materials), pesticides (including pesticide technical drugs), veterinary drugs, cosmetics, food, food additives, feed, feed additives, fertilizers and other products that are changed to other industrial uses, as well as raw materials or intermediates used in the production of the above-mentioned products, which belong to new chemical substances, shall be registered.
Applicant
The applicant is the subject of the environmental management registration of new chemical substances and is the holder of the registration certificate. The agent ceases to be the holder of the certificate of registration.
If the medicines, pesticides, veterinary drugs, cosmetics, food, food additives, feed, feed additives, fertilizers and other products specified in Article 2 of the Measures belong to new chemical substances and are intended to be changed to other industrial uses, the producers of related products, Importers or processing users can be used as applicants.
For chemical substances that have been listed in the "List" and are subject to environmental management for new uses, if they are intended to be used for other industrial uses other than permitted uses, the producers, importers or processing users of the relevant chemical substances can be the applicants.
Registration Type
regular registration: annual production or import volume of more than 10 tons;
Simple registration: annual production or import volume of more than 1 ton less than 10 tons;
Filing: One of the following conditions is met:
The annual production or import of new chemical substances is less than 1 ton;
Polymers with a monomer or reactant content of no more than 2% of the new chemical substance or polymers of low concern (requirements are not excluded from polymer filing).
Post-Registration Activity Report
First activity report: the holder or agent of the registration certificate, within 60 days from the date of the first production activity or the first import and transfer to the processing user.
Annual report: If the regular registration certificate stipulates the requirements for submitting an annual report, the holder of the registration certificate or his designated agent shall submit an annual report on new chemical substances before April 30 of each year starting from the year following the date of registration.
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