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Requirements for Post-registration Tracking Management of New Chemical Substances-Filing
Release time:
2022-01-19 10:10
On November 17, 2020, the Ministry of Ecology and Environment issued the Announcement on Issuing the Guidelines for the Registration of the Environmental Management of New Chemical Substances and Related Supporting Forms and Instructions for Filling in Forms (Announcement No. 51 of 2020). The official release of the "Guide" and other supporting documents marks that China's new chemical substance management regulations, policies and registration management have officially entered a new stage.
According to the "New Chemical Substances Environmental Management Measures" (Order No. 12) and its registration guidelines, if one of the following conditions is met, the environmental management of new chemical substances shall be filed:
(1) The annual production or import of new chemical substances is less than 1 ton;
(2) polymers with a monomer or reactant content of no more than 2% of the new chemical substance or polymers of low concern.
After the filing of new chemical substances, in addition to the requirements of the solid management center for compliance spot checks, there are certain regulatory requirements. After the filing, the tracking management requirements for new chemical substances are as follows:
General requirements
Filing applicants and processing users shall carry out activities in accordance with the filing situation. Processing users shall not process and use new chemical substances that have not been filed.
Information transfer
Producers, importers and processing users of new chemical substances pass the record receipt number to downstream users (including distributors and processing users) and inform them that they should continue to pass step by step until the final processing user. At the same time, the processing user can also request the supplier to provide the above relevant information. Information may be transmitted electronically or in written form, and the content and evidence of transmission shall be properly filed for future reference.
Post-Registration Activity Report
No requirements.
information disclosure
No requirements.
New Hazard Information and Environmental Risk Tracking
When researchers, producers, importers and processing users of new chemical substances discover that new chemical substances have new environmental or health hazard characteristics or environmental risks, they shall promptly report to the competent department of ecological environment under the State Council. If it may lead to an increase in environmental risks, measures shall be taken in a timely manner to eliminate or reduce environmental risks. Information on new environmental or health hazard characteristics or environmental risk and environmental risk control measures taken may be filled and submitted online through the online registration system. Cooperate with the competent department of ecological environment under the State Council to do a good job in tracking environmental risks, and submit relevant environmental or health hazards and environmental exposure data and information as required.
Data preservation
Researchers, producers, importers and processing users of new chemical substances establish a new chemical substance activity record system to record the time, quantity, actual use of new chemical substances, implementation of environmental risk control measures and environmental management requirements, and information transmission to downstream processing users. Encourage the use of information technology, digital means to establish a new chemical activity record system. If the applicant designates an agent, the agent in China shall perform the obligation to keep records and data of the new chemical substances. In the event of a change of agent, the applicant shall be responsible for coordinating the transfer and handover of information related to the new chemical substance activities between the original agent and the new agent. Record materials and activities records and other relevant information should be kept for at least three years.
Accept environmental supervision and management
Researchers, producers, processing users, importers and agents of new chemical substances shall, in accordance with the provisions of Article 43 of the measures, truthfully provide relevant information, and accept and cooperate with the supervision and spot check on the environmental management of new chemical substances carried out by the competent department of ecological environment. Those who violate the relevant provisions of the measures shall be punished by the competent department of ecological environment under the State Council or the local competent department of ecological environment in accordance with the corresponding circumstances of legal liability in Chapter 5 of the measures.
Chemical substances into the List
Record of chemical substances can not be included in the list.
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