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Ms. Ting Shen and Ms. Nelly Chen from REACH24 will elaborate on the newly introduced Guidance at CRAC-HFC 2020. Click the picture above to register!
On November 17th, 2020, the Chinese Ministry of Ecology and Environment (MEE) published the Guidance on Environmental Management Registration of New Chemical Substances [1], along with tables used in registration of new chemical substances and instructions for filling in the tables, following a public consultation [2] opened in August this year.
Earlier on April 29th this year, the MEE published the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12 of 2020) [3]. The Measures will come into force on January 1st, 2021 to replace the MEP Order No.7 which has been in effect for a decade.
The Guidance is a normative document dedicated to supporting the implementation of MEE Order No. 12. It specifies requirements concerning various aspects in the registration of new chemical substances, including registration scope, types and procedures, application materials, special provisions for polymers, change, withdrawal and revocation of registration and post-registration management, etc.
1. Major Changes Made in the New Guidance
Improved Requirements of Application Materials
On the basis of domestic regulatory experiences and realities, international practices and voices of industry players, the Guidance further details the specific requirements concerning quantitative environmental risk assessment, socio-economic benefit analysis of highly hazardous chemicals, necessity evaluation of identification information protection, application for the extension of information protection, new usage management, etc.
Optimized Data Criteria and Requirements
The Guidance provides the requirements concerning the categorized and stratified submission of data, promotes the application of computational toxicology, specifies the criteria of highly hazardous chemicals, and reduces high-cost tests to ease burdens on enterprises while keeping environmental risks under control. Changes in this regard will be further clarified in the second part.
Refined Requirements of Post-registration Management
Based on relevant provisions in the Measures, the Guidance details the requirements of new chemical information communication, first-time activity report and annual report, follow-up management of new hazard information and environmental risks, information disclosure, etc. Meanwhile, the tables which are required for registration of new usage as well as the change, withdrawal and revocation of registration certificate are improved to provide facilitation for applicants.
Standardized Work on Registration Application and Follow-up Management
A total of 14 tables are formulated, including those for registration application, information reporting, etc. Applicants are required to use the tables while preparing and submitting application materials and implementing follow-up management requirements.
2. Adjustments Made in Data Requirements
Categorized and Multi-Level Approach to Data Submission
The Guidance divides data into two categories, namely minimum required data and other data. In the case of regular registration or simplified registration, an applicant may usually submit only the minimum required data; where the minimum required data is not sufficient to support environmental risk assessment in regular registration, other data shall be submitted with regard to exposure pathways. The minimum required data include basic data and specially required data, with the latter applying to only chemicals which are persistent and/or bioaccumulative.
Clarified Requirements of Assessment and Analysis Reports
It requires that the environmental risk assessment be conducted on a quantitative basis, and provides specific rules concerning hazard assessment, exposure assessment, environmental risk characterization, etc. With regard to socio-economic benefit analysis reports which are required for highly hazardous chemcials, there shall be adequate evidence for whether new chemicals are relatively or significantly advantageous, compared with chemicals which are already in use, in terms of their impacts on human health or the environment and socio-economic benefits.
Testing and Non-testing Data Requirements
In the minimum required data, basic data should be derived from testing reports, and specially required data should come mainly from testing reports. It is preferable that other data come from testing reports. Where tests cannot be conducted in reality, the data submitted can be derived from non-testing data as well. The Guidance increases items for which computational toxicological data can be submitted as a supplement to screening testing data.
Eased Requirements of Specially Required Data for Intermediates of Pesticides, Pharmaceutics and Veterinary Drugs
The usage of intermediates of pesticides, pharmaceutics and veterinary drugs rarely changes, and such substances usually cannot be found in final products and thus pose relatively low risks to the environment and human body as a result of long-term exposure. Therefore, in order to minimize the impact of new chemical registration on pharmaceutical R&D, the Guidance provides that in applying for registration of intermediates of pesticides, pharmaceutics and veterinary drugs, applicants can submit basic data only.
3. Submission of Application Materials and Reports
The MEE has updated the system for environmental management registration of new chemicals to enable “access via one website” for the application and approval of registration. According to the Guidance, all the following procedures shall be completed via the online registration system on the government services platform of the ecology and environment administration under the State Council:
Ø Submit application materials, including applications for regular or simplified registration, or the change, withdrawal and revocation of registration;
Ø Complete record filing or change any information in record filing;
Ø Fill in the first-time activity report and annual report, export the reports, and upload the reports signed with signature and stamp to the online registration system
Meanwhile, applicants can check the progress of application approval, and print registration certificates or record filing receipts using the online registration system.
