On October 24, 2026, the Ministry of Ecology and Environment (MEE) officially released the Measures for Environmental Management Registration of New Chemical Substances (MEE Order No. 40), which took effect immediately upon publication, simultaneously abolishing the former Order No. 12. This revision marks the first supporting departmental regulation implemented by the MEE in the field of chemical environmental management following the adoption of the Ecological Environment Code on March 12 and its subsequent enforcement on August 15 of this year. Consequently, the environmental management of new chemical substances is transitioning from the "departmental regulation era" into the "Ecological Environment Code era."
The revision of the Measures for Environmental Management Registration of New Chemical Substances went through three phases: public consultation, deliberation, and official release. Under the new regulations, the regulatory logic has been fundamentally reshaped:
Escalated Penalties: The upgrade of the overarching legal framework has significantly intensified punitive measures, raising the cost of non-compliance to the million-yuan level.
Registration Overhaul: The previous fast-track filing channels for low-tonnage substances and polymers have been abolished, with a comprehensive shift to nominal registration.
Stricter Applicant Requirements: Eligibility for applicants has been tightened, and compliance responsibilities are now localized within China, effectively phasing out the previous registration agent models for overseas enterprises.
Refined Exemptions: The scope of exemptions has been redefined, with boundary adjustments specifically for pharmaceuticals and agrochemicals.
Optimized Processes: Testing requirements and review timelines have been synchronized and optimized.
These policy changes directly impact enterprises in fine chemicals, new materials, pharmaceuticals, agrochemicals, and cross-border supply chains. Companies must now re-strategize their new product R&D schedules, domestic and international commercial agreements, and the allocation of compliance responsibilities.
In this webinar, CIRS Group will conduct an in-depth breakdown of the core changes in the new regulations, assess their industry-wide impacts, and share actionable, practical compliance strategies.
