Requirements for post-registration tracking management of new chemical substances-regular registration

Release time:

2022-03-15 10:14

The last two articles in this series:

Requirements for Post-registration Tracking Management of New Chemical Substances-Filing

Requirements for Tracking Management after Registration of New Chemical Substances-Simple Registration

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 registration guidelines, if the annual production or import volume of new chemical substances is more than 10 tons, the new chemical substance environmental management regular shall be registered (hereinafter referred to as regular registration).

After the regular registration of new chemical substances is approved, the corresponding regulatory requirements need to be fulfilled. The tracking management requirements for regular registration of new chemical substances are as follows:

General requirements

Registration applicants and processing users shall carry out activities in accordance with 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 and environmental management requirements.

The regular registration certificate is valid from the date of issue to the date on which the new chemical substance is included in the List. If the holder of the registration certificate voluntarily applies for revocation of the registration certificate or is withdrawn or revoked according to law for other reasons, the validity period of the registration certificate shall be from the date of issuance to the date of receipt of the revocation receipt or the date of withdrawal or revocation according to law.

Information transfer

Producers, importers and processing users of new chemical substances transmit to downstream users (including distributors and processing users) the registration certificate number, application use, environmental and health hazard characteristics and environmental risk control measures, as well as the environmental management requirements stated in the registration certificate, 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

First activity report: The holder of the registration certificate or his designated agent shall submit the first activity report of the new chemical substance within 60 days from the date of the first production activity or the first import and transfer to the processing user, 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 information of the processing user, the environmental risk control measures and the implementation of the environmental management requirements.

Annual report: If the environmental management requirements on the registration certificate stipulate the requirements for submitting annual reports, 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. The annual report includes the actual activities of the new chemical substances approved for registration in the previous year (including total production or import, transfer, processing user information), information transmission to downstream users, emissions to the environment (which can be derived from monitoring reports or estimated data), and the implementation of environmental risk control measures and environmental management requirements.

The processing user should provide relevant information to assist the holder of the registration certificate in completing the annual report.

information disclosure

regular producers and processing users of registered new chemical substances shall make public the implementation of environmental risk control measures and environmental management requirements through their official websites or other ways that are convenient for the public to know after their first activities, and update them in a timely manner. The manner and content of the disclosure must be properly filed for future reference.

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 shall establish a record system for the activities of new chemical substances, and truthfully 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. regular registration materials and activity records (such as registration application materials, first activity reports, annual 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

For new chemical substances that have obtained regular registration certificates (including new chemical substances that the applicant applies for cancellation of regular registration), if five years have expired from the date of first registration, the competent department of ecological environment under the State Council shall be listed in the list.

regular registered new chemical substances withdrawn or revoked by the competent authorities in accordance with the Measures shall not be included in the Directory.

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