New chemical substances environmental management registration linkage matters interpretation came

Release time:

2020-06-05 11:31

On April 29, 2020, the Ministry of Ecology and Environment promulgated 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 the Measures), which will come into force on January 1, 2021, and 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Substances (Order No. 7 of the Ministry of Environmental Protection, hereinafter referred to as Order No. 7) shall be repealed at the same time.

In order to ensure the orderly continuation of the registration of environmental management of new chemical substances, on June 3, 2020, the Ministry of Ecology and Environment organized and issued the ''Notice on Matters Concerning the Registration of Environmental Management of New Chemical Substances (Draft for Solicitation of Comments) '', from the date of release To June 20, 2020, solicit opinions from various agencies, organizations, enterprises, institutions and individuals.

After carefully studying the draft, Xiao An summarized the contents that have a great impact on customers and friends as follows:

Holder of Registration Certificate

Notification content:

The holder of the regular registration certificate shall, in accordance with the provisions of articles 38, 39, 41 and 42 of the measures, carry out information transmission, data recording and preservation, first activity report and new hazard information report.

The holder of the simplified registration certificate shall record and preserve the information in accordance with the provisions of Article 39 of the Measures.

Interpretation: Under Decree 12, information transmission, data recording and storage, first activity report and new hazard information report shall be undertaken by researchers, producers, importers and processing users. However, in the case of obtaining a registration certificate under Order 7, it shall be borne by the holder of the registration certificate. Agents under Order 7 as holders of registration certificates require additional attention.

Annual Report

Notice content: key environmental management of hazardous new chemical substances shall be in accordance with the provisions of Article 41 of the measures to submit annual reports.

Interpretation: The draft for comments only lists new hazardous chemical substances in key environmental management. It is expected that hazardous substances and simple registration certificates under the "Measures" do not need to provide annual reports.

Key Environmental Management Hazard Category

In accordance with the key environmental management hazardous new chemical substances identified in Decree No. 7, continue to implement the environmental management registration for new uses, and specify permitted uses when they are included in the "List of Existing Chemical Substances in China.

Interpretation: After the new chemical substances in the key environmental management category are included in the list, the new use environmental management shall be implemented.

Change of Registration Certificate

Notification content:

If the holder of the regular registration certificate intends to change the information contained in the registration certificate, he shall re-apply for registration in accordance with the relevant provisions of the "Measures" and obtain a new chemical substance environmental management registration certificate.

If the holder of the simple registration certificate intends to change the information contained in the registration certificate, he shall, in accordance with the relevant provisions of the measures, apply for the record of environmental management of new chemical substances, or apply for registration again, and obtain the registration certificate of environmental management of new chemical substances.

Interpretation: The regular registration certificate under the current Decree No. 7 only needs to provide corresponding instructions and supporting documents for the name of the holder of the registration certificate and the change of quantity within the order of magnitude, and there is no need to re-declare. It is suggested that customers and friends check the registration certificate of new chemical substances in their hands. If there is a need to change the quantity within the order of magnitude, contact us as soon as possible to make relevant changes.

New chemical substances that have been accepted under Decree No. 7 but have not been registered before the entry into force of the Measures

Notification content:

For the new chemical substance environmental management registration declaration that has been accepted before the entry into force of the Measures, if the application materials do not meet the requirements or the normal approval process cannot be completed within the processing time limit, etc., the registration certificate cannot be obtained before the Measures take effect, shall Apply for registration of new chemical substance environmental management in accordance with the relevant provisions of the "Measures.
Interpretation: It is only half a year since the "Measures" came into effect, and this provision has a greater impact on the ongoing regular registration projects. Relevant enterprises or individuals are requested to give positive feedback to the Ministry of Ecology and Environment before June 20. You can also give your feedback to Xiao An, and we will submit it on your behalf.

Key Points of Registration and Management of Pharmaceutical Excipients under the New Deal

Introduction to the whole process of hazardous chemicals registration in China

Key Points of Registration and Management of Pharmaceutical Excipients under the New Deal

Introduction to the whole process of hazardous chemicals registration in China

Latest developments

Key Illustration of Railway Transportation Regulations for Consumer Lithium Battery Cargo

Recently, the Ministry of Industry and Information Technology of the National Railway Administration China National Railway Group Co., Ltd. announced the guidance on the railway transportation of consumer lithium battery goods. For details, please refer to our public article. Official

Answers to Frequently Asked Questions about the Environmental Management Measures for New Chemical Substances (Order No.7)

I recommend: For pre-registration projects with large tonnage and short grace period, or small tonnage pre-registration projects that are clearly registered in the future, it is recommended to choose joint registration and join the joint registration IT system agreement this time. For pre-registration projects that are clearly not registered in the future, it is recommended to choose subsequent registration. May I ask you

Cancellation of GMP certification means stricter supervision of drug production?

The cumbersome process of GMP and GSP certification has made many pharmaceutical manufacturers and distribution companies feel the strict supervision of the pharmaceutical industry. On September 25, 2019, the State Food and Drug Administration issued a notice on the study, publicity and implementation of the the People's Republic of China Drug Administration Law., It is clearly proposed to strengthen dynamic supervision and cancel the drug production quality management practice (GMP) certification and the drug business quality management practice (GSP) certification.

Dry goods! Common technical questions and answers on new raw materials for cosmetics