MEE of China has issued notice about the review result of the second batch of application of New Chemical Substance Regular Registration Certificate in 2022.
By authorizing CNCIC to take charge of the whole registration job, Shenyang Dongrui Fine Chemical Co., Ltd has successfully obtained regular registration certificate after publicity period, which is also the first regular registration certificate under the new regulation that we assisted client to obtain.
‘Measures for Environmental Management Registration of New Chemical Substances ‘(MEE Order No. 12) has been issued on 29th April, 2020, and implemented on 1st January, 2021.
When we launched this project, firstly we arranged tests reasonably based on our years’ of experiences on new chemical substance registration, and all tests were completed within 7 months smoothly.
In the process of materials and risk assessment report preparation, we strictly follow the requirements of ‘Guidelines for environmental management registration of new chemical substances’，‘Technical guidelines for environmental and health hazard assessment of chemical substances’, ‘Technical guidelines for environmental and health exposure assessment of chemical substances’ and ‘Technical guidelines for environmental and health risk characterization of chemical substance’.
Finally, the formal review and expert technical review were successfully passed.
As we all know, MEE has approved and issued only five regular registration certificates after the implementation of Order No.12, just because the requirements for regular registration’s review are much more strict now.
By obtaining this regular registration certificate, it is indicated that the technical materials prepared by CNCIC for the regular registration of DONGRUI were recognized by MEE’s experts committee..
Advice For Enterprises：
1. Make reasonable project plan and respond actively
MEE Order No. 12 has been implemented for more than one year. Compared with previous MEP Order No. 7, requirements on materials, risk assessment report and analysis of social and economic Benefits of MEE Order NO. 12 has been stricter. In particular, it is required to provide detailed information as much as possible and have sufficient basis for the discharge and disposal of three wastes, exposure assessment etc. in risk assessment report.
If information provided by enterprises are uncompleted, unscientific, unreasonable or fail to fill in the information in strict accordance with the requirements of registration system, multiple correction request will be asked for by MEE-SCC, resulting in delay of project’s deliver. Therefore, it is recommended that enterprises make plans in advance and start the project as soon as possible.
2. Arrange Tests Reasonably
MEE Order No. 12 focuses on high hazardous chemical substance, such as PBT, vPvB or high hazardous substances with the same environmental/health hazards. test data requirements are also related to the P and B properties of the substance.
Therefore, we suggest that enterprises should reasonably arrange tests in combination with the nature of the substance to be applied for to avoid the omission of test items.
During the test, it is also necessary to track and supervise the test progress. Once the preliminary test results show the substance has special properties, further tests should be started immediately.
For intermediates of pharmaceutical, pesticide and veterinary medicine, tests can be carried out according to the minimum data requirements. For substances with P or B property, QSAR reports could be submitted for toxicological endpoints instead of tests, which can save a large amount of test cost and time.
3. Select a Consulting Institute with Technical Strength to do the Job
Although MEE Order No. 12 has been implemented since 2021, the management requirements of new chemical substances have started long time ago. It originates from the Environmental Management Measures for New Chemical Substances (Order No. 17 of the former State Environmental Protection Administration) implemented on October 15, 2003.
As the first institution engaged in the notification and registration service of new chemical substances in China, CNCIC has been working in the field of new substance compliance for nearly 20 years. We have accumulated rich compliance experiences in regular registration, especially in the field of intermediates and substances with special properties such as hydrolysis or explosion hazards.
If any enterprise has technical problems about the compliance of new chemical substances, you can contact us at any time.