After Decree No. 12 came into effect, the holder of the registration certificate obtained under Decree No. 7 fulfilled his responsibility to reveal the secret!

Release time:

2020-12-07 09:42

The 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 Order No. 12) will come into effect on January 1, 2021. Article 53 of the regulations clearly stipulates that if the environmental management of new chemical substances has been registered in accordance with the Measures for the Environmental Management of New Chemical Substances (Order No. 7 of the Ministry of Environmental Protection, hereinafter referred to as Order No. 7), the relevant registration shall continue to be valid. The Announcement on Linkage Matters Related to Environmental Management Registration of New Chemical Substances (Announcement No. 46 of 2020 of the Ministry of Ecology and Environment, hereinafter referred to as the Announcement), for new chemical substances that have obtained regular registration certificates and simple registration certificates under Order No. 7, details the tracking management requirements that should continue to be fulfilled after Order No. 12 takes effect, as well as the registration procedures for applying for cancellation and change.

Due to the different requirements on the responsibilities and obligations of the holders of registration certificates under the old and new laws and regulations, today we will talk about the responsibilities of the holders of regular and simplified registration certificates obtained in accordance with Order No. 7 that are still within the validity period. Continue to perform.

Basic Tracking Management Requirements

1、In order to ensure the effective prevention and control of environmental risks of new chemical substances registered under Decree No. 7 and the continuous implementation of relevant tracking management requirements, the announcement clearly puts forward the tracking management requirements after Decree No. 12 takes effect. Holders of regular registration and simple registration certificates need to continue to perform the obligations of new hazard information reporting and data preservation. If a substance is determined to need environmental management for a new use when it enters the List, it may need to be re-registered if it changes its use later.

2. New hazard information report: if new chemical substances are found to have new environmental/health hazard characteristics or environmental risks, they shall promptly report to the competent department of ecological environment under the State Council and take timely measures to eliminate or reduce environmental risks. /3,

3. Data preservation: The data to be preserved include the activity time, quantity and use of new chemical substances, as well as the implementation of environmental risk control measures and environmental management requirements, and the preservation period is at least ten years.

4. New use management: for chemical substances that are subject to environmental management for new uses after entering the list, the permitted uses are indicated in the list. after entering the list, they still fall within the scope of order 12. if they are changed to uses other than those included in the list, they shall apply to the competent department for registration of environmental management for new uses before production, import or processing. The holder of the registration certificate should pay attention to the announcement of the registered substance when it enters the "List" at any time. If the registered substance is judged to be of this kind, if it needs to change its use after entering the "List", please refer to the permitted use in the List to assess whether registration is necessary. Among them, the announcement has made it clear that the key environmental management hazardous substances will be in the "list" after all the new use of environmental management.

Special tracking management requirements for regular registered substances

1. After the order comes into effect, there is no need to provide a 5-year actual activity report when substances are included in the List, each report of key substances is canceled, and the scope of annual report submission is also reduced to key environmental management hazardous substances. The requirements for the first report and information transmission are similar to the previous requirements.

2. First Activity Report: If the first activity has not been carried out before January 1, 2020, the time of entry into the List is not related to the date of the first activity, and the new method will be automatically included in the List five years after it takes effect. However, the holder of the registration certificate still needs to report the first activity of the new chemical substance within 60 days after the first production or import and transfer to the processing user. /3

3. Information transmission: Decree No. 12 clearly stipulates the information that needs to be transmitted to downstream users, including registration certificate number, application purpose, environmental and health hazard characteristics of new chemical substances, environmental risk control measures and environmental management requirements. Compared with Decree No. 7, the registration certificate number, application purpose and environmental management requirements are added. If the information transmitted at that time does not fully cover the existing requirements, it is necessary to clearly transmit the relevant information again in the future and keep the corresponding records for future reference.

4. Annual report: Holders of registration certificates for key environmental management hazards are still required to submit annual reports every year after the implementation of Decree No. 12 until the declared substances are included in the List. The submission time is adjusted to April 30 each year, and the holder will have a longer time to collect the actual production and use information of the previous year before submission.

Revocation and change of registration certificate

1. Cancellation of registration certificate: The announcement clearly stipulates that the holder of the registration certificate of Order 7 may apply to the competent department of ecological environment under the State Council for cancellation of the registration certificate in accordance with Article 33 of Order 12.

2. Change of registration certificate: If it is necessary to change the information contained in the registration certificate of Decree No. 7, in principle, apply for the registration certificate or record in accordance with the provisions of Decree No. 12. At the same time, if the relevant information of the registration certificate will not increase the environmental risk after the change, the simplified procedure is clarified, and it is allowed to apply for the change of the registration certificate with reference to Article 30 of Decree No. 12. The specific circumstances under which the change can be applied are as follows:

Registration Type

Alterable situation

Regular

1. The registration volume is to be reduced;

2. The type of activity is intended to change from production to import or increase imports;

3. Registration of the Chinese and English name of the new chemical substance or the identification information such as the Chemical Abstracts Service number (CAS number) to be changed;

4. The name of the applicant or agent is to be changed.

Easy

1. The registered amount after the change is less than 1 ton/year;

2. If the registration certificate is obtained for the purpose of process and product research and development, the registration volume after the change is less than 10 tons, and the registration certificate is still within the validity period;

New chemical monomer content of not more than 2% of the polymer or belong to the low concern polymer.

Attached: Comparison and Description of Tracking Management Requirements

Requirements	Order 12	Order 7	Description
First report	Article 41 the holder of the registration certificate shall, within 60 days from the date of the first production, or within 60 days from the date of the first import and transfer to the processing user, report the first activity of the new chemical substance to the competent department of ecological environment under the State Council.	Article 35 The holder of the registration certificate declared by the activity reporting regular shall, within 30 days of the first production activity, or within 30 days of the first import and transfer to the processing user, submit the first activity report of the new chemical substance to the registration center. Form.	The object of the first report is consistent with the original scope, and the holder of the regular registration certificate who has not made the report is still required to make the report, and the reporting time is adjusted from 30 days to 60 days.
Annual Report	Article 26 where the environmental management requirements specified in the regular registration certificate stipulate the requirements for submitting annual reports, the holder of the registration certificate shall, starting from the year following the registration, report to the competent department of ecological environment under the State Council before April 30 each year on the actual production or import of new chemical substances approved for registration in the previous year, their discharge into the environment, as well as the implementation of environmental risk control measures and environmental management requirements.	Article 36 The holder of the registration certificate for the summary declaration of the annual report shall report to the registration center the actual production or import of the new chemical substances approved for registration in the previous year before February 1 of each year. The holder of the registration certificate of hazardous new chemical substances (including key environmental management hazardous new chemical substances) shall report to the registration center the following information about the new chemical substances approved for registration in the previous year before February 1 of each year... It should also report to the registration center the production or import plan of the new chemical substances registered in the current year, as well as the preparation for the implementation of risk control measures.	Only the registration certificate of new chemical substances whose substance category is a key environmental management hazard category under Decree 7 requires an annual report. If you hold a registration certificate of this type, you need to continue to fill in on time until the substance enters the List. The submission time is adjusted from before February 1 of each year to before April 30 of each year.
Information transfer	Article 38 Producers, importers and processing users of new chemical substances shall transmit the following information to downstream users: (I) registration certificate number or record receipt number; (II) new chemical substance applications; (III) environmental and health hazard characteristics of new chemical substances and environmental risk control measures; (IV) environmental management requirements for new chemical substances.	Article 30 Transmission of Information The holder of the registration certificate declared by the regular shall specify the hazard characteristics of the new chemical substance in the chemical safety technical specification and transmit the following information to the processing user: Risk control measures specified in the (I) registration certificate; Safety technical specification of (II) chemicals; (III) the classification results according to the chemical classification, warning labels and warning instructions safety regulations; (IV) other relevant information.	The content of information transmission has been adjusted according to the new requirements. Decree No. 7 does not require holders of simple registration certificates to transmit information. According to the announcement, after Decree No. 12 takes effect, holders of simple registration certificates still have no mandatory information transmission requirements.
Data preservation	Article 39 Researchers, producers, importers and processing users of new chemical substances shall establish a new recording system for the activities of new chemical substances, truthfully record the time, quantity and purpose of the activities of new chemical substances, as well as the implementation of environmental risk control measures and environmental management requirements. regular registration and summary registration materials and new chemical activity records and other relevant information should be kept for at least ten years. Record materials and relevant information such as records of new chemical substance activities shall be kept for at least three years.	Article 37 Preservation of information The holder of the registration certificate shall keep the declaration materials of the new chemical substance and the actual situation of the production and import activities for more than ten years.	Holders of regular registration certificates and simple registration certificates are required to keep the relevant registration information for 10 years as required.
New Information Report	Article 42 if 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. When necessary, the corresponding registration certificate may be changed or withdrawn according to the evaluation results.	Article 26 New feature reporting and processing New characteristics report and processing When the holder of the registration certificate discovers that the new chemical substance approved for registration has new hazardous characteristics, he shall immediately submit new information on the hazardous characteristics of the chemical substance to the registration center. The registration center shall submit new information on the hazardous characteristics of new chemical substances approved for registration to the review committee for technical review. According to the technical review opinions of the review committee, the Ministry of Environmental Protection takes the following measures:... And to be announced.	The holder of the registration certificate still needs to report new information, and there are also higher requirements for risk control. If an increase in risk may be involved, it is necessary to take timely measures to reduce or eliminate environmental risks while waiting for the assessment by the competent authority. Action is taken after the results are produced.
New Use Management	Article 31 If the holder of the registration certificate changes its use, or if someone other than the holder of the registration certificate uses it for industrial purposes, it shall apply to the competent department of ecological environment under the State Council for environmental management registration of new uses before production, import or processing.	Article 27 Re-declaration (II) change the registered use of new chemical substances in the hazardous category of key environmental management. New chemical substances that have been included in the "List of Existing Chemical Substances in China" and have been approved for registration of key environmental management hazardous substances can also be re-declared by the processing users of the registered new chemical substances.	After the substance enters the "List", if it is determined as a new-use environmental management substance, if it needs to be changed to the use not collected in the "List", it is necessary to handle the new-use environmental management registration.
Application for inclusion in the directory	Article 44: If a new chemical substance that has obtained a regular registration certificate has been registered for five years from the date of first registration, the competent department of ecology and environment under the State Council shall include it in the "List of Existing Chemical Substances in China" and announce it. Article 45 If a new chemical substance that has obtained a regular declaration and registration certificate in accordance with the Environmental Management Measures for New Chemical Substances (Order No. 7 of the Ministry of Environmental Protection) has not been included in the List of Existing Chemical Substances in China, it shall be listed in the List of Existing Chemical Substances in China after five years from the date of first production or import activities or five years from the date of implementation of these Measures.	Article 41 Procedures for inclusion in the list of existing chemical substances General new chemical substances shall be listed in the list of existing chemical substances in China by the Ministry of environmental protection for five years from the date of the first production or import activities of the holder of the registration certificate. The holder of the registration certificate of hazardous new chemical substances (including key environmental management hazardous new chemical substances) shall submit a report on the actual activities to the registration center six months before the expiration of five years from the date of the first production or import activities.	The requirements for entering the "List" are simplified. Holders of new chemical substance registration certificates for hazardous categories (including key environmental management hazardous categories) do not need to apply. At the same time, the actual activities within five years will be reported. The competent authority will announce the inclusion according to the time. The time of entry into the List shall be the earlier of the first activity and the five years after the entry into force of Decree 12.
Each report		Article 35 The holder of the registration certificate of the new chemical substance of the key environmental management hazardous category of the activity report shall also report the flow direction information of the new chemical substance to the registration center within 30 days from the date of each transfer of the new chemical substance of the key environmental management hazardous category to different processing users.	This requirement has been canceled