China’s Ministry of Ecology and Environment recently published a major update to its chemical management framework. The newly revised Measures for the Environmental Management Registration of New Chemical Substances—referred to as MEE Order 40—replaces the existing Order 12.
A representative of the Department of Solid Wastes and Chemicals under the Ministry of Ecology and Environment answered questions from the press regarding details of MEE Order 40.
Official Q&A
Q1: What triggered this regulatory update?
A: In May 2022, the General Office of the State Council released the Action Plan for New Pollutant Governance, establishing the environmental management registration system for new chemical substances as a vital front-line defense to control pollution at its source and prevent new pollutants from emerging.
In March 2026, the Fourth Session of the 14th National People's Congress enacted the Ecological Environment Code of the People's Republic of China. Taking effect on August 15, 2026, the Code sets forth statutory requirements for registering new chemical substances.
To align with the central government's strategic decisions and implement the Code's provisions, the MEE updated the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order 12). This revision incorporates practical regulatory experience to better steer registration procedures and strengthen the system's role as a preventive "firewall."
Q2: What core principles guided the revision process?
A: The revision followed three main principles:
- Targeted Amendments: The revision strictly adhered to the framework of the Code, focusing modifications specifically on aligning provisions that were inconsistent with the new statutory baseline.
- Policy Continuity: We preserved the categorized management established under MEE Order 12. By factoring in chemical quantities, categories, and environmental risk profiles, we maintained precise, science-based management.
- Open and Transparent Consultation: Throughout the drafting process, we actively gathered feedback from diverse parties through industry symposiums, public comment periods, and World Trade Organization (WTO) notification channels.
Q3: What are the main regulatory changes introduced in MEE Order 40?
A: MEE Order 40 introduces two critical structural updates to chemical registration in China:
Restricted Applicant Eligibility:
Under Article 650 of the Code, registration certificates must be held directly by the Chinese enterprise or institution manufacturing or importing the substance. Order 40 removes the ability of overseas manufacturers, foreign traders (via domestic representative agents), and downstream processors to apply directly.
Transition from Record-keeping to Nominal Registration:
Article 651 of the Code strictly prohibits manufacturing or importing new chemical substances without an explicit registration certificate. Consequently, the former record-keeping system is elevated to a formal, permit-based Nominal Registration. Data submission and technical documentation requirements remain largely consistent with former record-keeping standards.
Q4: How will existing registrations and record-keepings be handled during the transition?
A: In accordance with the non-retroactivity principle:
Registration certificates lawfully obtained under MEE Order 12 before Order 40 takes effect, and record-keeping with the receipts acquired prior to August 15, 2026, remain fully valid.
If details recorded in the record-keeping receipt or an overseas enterprise's registration certificate change, application for registration should be submitted by an eligible applicant meeting the requirements of MEE Order 40.
Q5: What measures is the MEE taking to support industry compliance under Order No. 40?
A: To ensure seamless enforcement, the Department of Solid Wastes and Chemicals under MEE is implementing a three-part rollout strategy:
- Public Outreach & Guidance: Providing clear policy interpretations and administrative support to help enterprises understand updated compliance duties.
- Platform & Technical Upgrades: Updating the online registration portal, revising administrative service guidelines, and streamlining technical evaluation standards to improve processing efficiency.
- Enforcement & Supervision: Directing local ecology and environment departments to increase supervisory capacity and enforce compliance across manufacturing and import supply chains.
Free Webinar
To help related enterprises better cope with the revised Measures, CIRS is to host a free webinar on November 12, 2026 at 8:30-9:30 AM (GMT) and 1:00 – 2:00 PM (EST), to introduce the new regulations in details from three parts:
- The core changes in the new regulations,
- Impacts on enterprises, and
- Actionable, practical compliance strategies.
How CIRS Group Can Help
CIRS Group will closely monitor the rollout and enforcement of China’s new chemical regulations. Our regulatory team remains dedicated to delivering expert guidance, strategic compliance consulting, and tailored solutions to ensure your business navigates China’s evolving regulatory landscape seamlessly.
Our Services
- China new chemical substance registration;
- IECSC Enquiry and Inventory Adding;
- Chemical Safety Report (CSR) Compilation;
- Testing Coordination/Supervision;
- Alternative methods (QSAR, Read-Across, In-vitro, Waiver, Evaluation);
- Post-registration (Annual Report, Certificate Renewal)
- China REACH Training Service;
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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