China REACH: MEE Order No. 40 Takes Effect, Replacing MEE Order No. 12
Reference source : Regulations of the Ministry of Ecology and Environment
On 24 October 2026, China’s Ministry of Ecology and Environment (MEE) promulgated the Measures for Environmental Management Registration of New Chemical Substances (MEE Order No. 40), effective from that date. It repeals Order No. 12.
Scope and Registration
The Measures cover production and import; processors and users retain compliance duties. Certain pharmaceuticals, cosmetics, food, feed, fertilisers and radioactive materials are excluded, with stated exceptions. Articles designed to intentionally release new chemical substances during normal use are covered.
Three registration categories apply: routine registration for annual volumes of 10 tonnes or more; simplified registration for 1 to less than 10 tonnes; and formal registration for less than 1 tonne and specified polymers. Producers and importers must obtain a registration certificate before production or import. Applicants must be China-established entities engaged in production or import.
Applications and Ongoing Obligations
Applicants must submit relevant physicochemical, toxicological and ecotoxicological data, along with environmental risk assessments for routine registration. Simplified and formal registrations have specific data requirements. Joint applications and applications for multiple similar substances are permitted.
Technical Review: Up to 60 days for routine registration and 30 days for simplified and formal registration.
Registration Decision: Generally, within 20 working days of application acceptance, extendable by 10 working days. The technical review period is excluded from this timeline.
Producers and importers must communicate registration and hazard information to downstream users. Records must be retained for 10 years (routine and simplified) or three years (formal). First-activity reporting is required within 60 days, with annual reporting by 30 April where applicable. Certain changes require re-registration, while specified hazardous substances are subject to new-use management. Routine-registered substances are generally added to the IECSC after five years.