The Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12), effective January 1, 2021, establishes a cutting‐edge regulatory standard for new chemical substances in China. This guide explains the registration process, types, scope, exemptions, and key compliance services for companies targeting the Chinese market.
Introduction to MEE Order No. 12
The Measures for the Environmental Management Registration of New Chemical Substances (Order No. 12 of the Ministry of Ecology and Environment of the P. R. China, MEE Order No. 12) was released in April 2020 and came into effect from January 1, 2021. It has replaced the Measures on the Environmental Management of New Chemical Substance (MEP Order No.7) and become a brand-new management standard for new chemical substances in China.
MEE Order No. 12 introduces updated registration requirements for chemical substances not listed in China’s Inventory of Existing Chemical Substances (IECSC). Companies intending to manufacture or import such substances must submit registration dossiers to the Solid Waste and Chemicals Management Center of MEE (SCC-MEE) and obtain certification before entering the market. Non-compliance with these regulations may result in severe penalties.
Key Highlights:
• MEE Order No. 12 is a core part of China’s environmental management and chemical compliance system.
• It focuses on new chemical substances that are excluded from the IECSC.
• Non-compliance can lead to severe enforcement actions, emphasizing the need for rigorous adherence.
China's Inventory of Existing Chemical Substances
Existing Chemical Substances in China refer to chemical substances that have been manufactured, imported, or used in China prior to October 15, 2003, and are listed in the Inventory of Existing Chemical Substances in China (IECSC). This inventory serves as the official regulatory register for chemicals legally recognized as "existing" in the country.
Maintained by the Ministry of Ecology and Environment (MEE), the IECSC categorizes chemicals already present in the Chinese market. Substances not listed are considered "new chemical substances" and require registration, evaluation, and approval before production, import, or use.
Substances Requiring Registration
MEE Order No. 12 mandates the registration of “new” chemical substances in China. In this context, “new” refers to those chemical substances that are not included in the Inventory of Existing Chemical Substances of China (IECSC).
For chemical substances that have been incorporated into the IECSC and are subject to environmental management due to new uses, if they are employed in industrial applications beyond the permitted uses, they will be managed as new chemical substances under environmental regulations.
The Measures do not apply to the following two categories:
Pharmaceuticals (including active pharmaceutical ingredients), pesticides (including pesticide technical materials), veterinary drugs (including veterinary drug substances), cosmetics, food, food additives, feed, feed additives, fertilizers, etc.; and
Radioactive materials.
Furthermore, the following categories are exempt from registration:
Naturally occurring substances;
Substances produced non-commercially or unintentionally;
Other special categories, including materials, alloys, non-isolated intermediates, articles, etc.
Who Should Apply for Registration?
• Manufacturers or direct importers of new chemical substances in China.
• Overseas companies must appoint a representative agent when submitting a registration application.
• If exempt products listed in Article 2 of the Measures involve new chemical substances intended for other industrial applications, the applicant may be the manufacturer, importer, processor, or user.
• For chemical substances subject to new usage environmental management that are intended for industrial applications beyond permitted uses, or for highly hazardous substances without a regular registration certificate for the intended use, the applicant can be the manufacturer, importer, processor, or user.
Note: Companies from Hong Kong, Macau, and Taiwan are required to appoint a representative agent in Mainland China to complete the registration process.
Registration Types and Volume Criteria
Under MEE Order No. 12, new chemical substances are registered under three types: regular registration, simplified registration, and record notification.
Notably, substances produced or imported for R&D purposes in quantities of less than 0.1 ton per year are not exempt. In other words, regardless of the volume of production or import, every new chemical substance must comply with the designated registration or notification requirements.
Record Registration
New chemical substances manufactured or imported with an annual volume of less than 1 ton;
Polymers containing less than 2% monomers or reactants which are new chemical substances, or polymers of low concern (no volume limit).
New chemical substances not conforming to the record registration conditions for polymers or meeting the exclusion requirements for polymers shall be subject to regular or simplified registration.
Simplified Registration
1 t/a ≤ Annual Manufacturing / Importation Volume < 10 t/a
Regular Registration
Annual Manufacture / Importation Volume ≥ 10 t/a;
FAQ
Q: How do I report the first activity for a regular new chemical substance registration?
A: In accordance with the Environmental Management Registration Guidelines (MEE Bulletin 2020 No. 51), the first activity report must be completed online via the registration system. Log in to the Ministry of Ecology and Environment’s government service portal at http://zwfw.mee.gov.cn, select ‘New Chemical Substances’, and then access the ‘13002 New Chemical Substance Environmental Management Registration and Certificate Issuance Approval’ item. Follow the prompts to enter the ‘Regular Registration’ section and click on ‘First Activity Report’ to complete, output, sign, stamp, and upload your report.
Q: How is the annual report submitted for new chemical substances under MEE Order No. 12?
A: Per the Environmental Management Registration Guidelines (MEE Bulletin 2020 No. 51), the annual report should be filled out online in the registration system. Visit http://zwfw.mee.gov.cn, select ‘New Chemical Substances’, and click on the ‘13002 New Chemical Substance Environmental Management Registration and Certificate Issuance Approval’ item. Enter the ‘Regular Registration’ section and then choose ‘Annual Report’ to complete, output, sign, stamp, and upload your report online.
Q: For an importer of new chemical substances under a regular registration (import type) used only for laboratory self-use and not for sale, is a first activity report required?
A: Yes, a first activity report is required. According to the Announcement on the Connection of New Chemical Substance Registration Matters (MEE Bulletin 2020 No. 46), even if the material is used solely for laboratory purposes, the holder of a regular registration certificate must submit a first activity report within 60 days following the first production or import and transfer to a processor.
Q: Can an applicant hold both a simplified registration certificate and a regular registration certificate for the same new chemical substance simultaneously?
A: No, an applicant cannot hold both certificates at the same time. As stated in the Environmental Management Registration Guidelines (MEE Bulletin 2020 No. 51), if a new chemical substance qualifies for simplified registration and then opts for regular registration under the higher application criteria, the new, regular registration certificate will replace the simplified registration certificate.
Our Comprehensive Services
We offer a full spectrum of regulatory compliance consulting services, which include:
Comprehensive Regulatory Compliance Consulting
Representative Agent Service
IECSC Comprehensive Search
Inventory Listing Application
New Usage Management Identification
New Chemical Substance Registration (Record Registration/Simplified Registration/Regular Registration/New Usage Management Registration)
Overall Registration Scheme
Data Assessment/Data Gap Analysis/Exemption Analysis/PBT Properties Identification
Non-testing Assessment Report (Toxicokinetics Assessment Report, QSAR, Read-across)
Test Monitoring
Risk Assessment Report / Social Economic Effectiveness Analysis Report Preparation
Communication with Competent Authorities/Experts
Translation for Registration Documents
Post-registration Obligations (Annual Report, Certificate Renewal, etc.)
Customized Training
Why Choose REACH24H?
With over 10 years of specialized expertise in China’s chemical management compliance, our organization has successfully submitted more than 3,000 applications under MEP Order No. 7.
We boast a dedicated team of over 30 experts in toxicology, analytical chemistry, chemical engineering, biology, and related fields, capable of addressing complex challenges in chemical regulation. Offering multilingual support in English, Chinese, Japanese, Korean, and German, we bring extensive global regulatory compliance expertise to every project.
Our strong partnerships with robust testing facilities and close relationships with regulatory authorities and industry experts ensure that our clients receive unparalleled service and guidance.
Conclusion
This guide is designed to help companies meet the stringent requirements of China’s new chemical substance registration regime under MEE Order No. 12. For further assistance in navigating China’s environmental management and chemical registration landscape, please contact us.
REACH24H CONSULTING GROUP CHINA
Tel: +86-571-87103805
Email: customer@reach24h.com
