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Requirements for Tracking Management after Registration of New Chemical Substances-Simple Registration
Release time:
2022-02-28 10:13
Previous article in this series:Requirements for Post-registration Tracking Management of New Chemical Substances-Filing
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).
According to the "New Chemical Substance Environmental Management Measures" (Order No. 12) and its guidelines, if the annual production or import volume of new chemical substances is more than 1 ton but less than 10 tons, the new chemical substance environmental management simple registration (hereinafter referred to as simple registration) shall be handled.
After the simple registration of new chemical substances is approved, the corresponding regulatory requirements need to be fulfilled. The tracking management requirements for simple registration of new chemical substances are as follows:
General requirements
Registration applicants and processing users shall carry out their activities in accordance with the items specified in the registration. Processing users shall not process and use new chemical substances that have not been registered. The registration certificate shall not be transferred.
Researchers, producers, importers and processing users of new chemical substances shall implement environmental risk control measures.
Information transfer
Producers, importers and processing users of new chemical substances transmit to direct downstream users (including distributors and processing users) the registration certificate number, application use, environmental and health hazard characteristics of new chemical substances, and environmental risk control measures, and inform them that they should continue to be transmitted 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
The holder of the registration certificate or his designated agent shall, within 60 days from the date of the first production activity or the first import and transfer to the processing user, submit the first activity report of the new chemical substance, including the information of the domestic production/import unit, the time, place and activity volume of the first activity, the information transferred to the processing user, the processing user information, the environmental risk control measures, etc.
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.
Researchers, producers, importers and processing users of new chemical substances shall 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. Simple registration materials and activity records (such as registration application materials, first activity reports, information transmission materials, etc.) and other relevant information shall be kept for at least ten years.
Accept environmental supervision and management
Researchers, producers, processing users, importers and agents of new chemical substances shall truthfully provide relevant information, and accept and cooperate with the supervision and random inspection of the environmental management of new chemical substances carried out by the competent department of ecological environment.
Chemical substances into the List
Chemical substances that are simply registered are not included in the List.
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