Overview

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 shall apply if companies plan to manufacture or import chemicals not listed in the Inventory of Existing Chemical Substances in China (IECSC). Registration dossiers should be submitted to the Solid Waste and Chemicals Management Center of MEE (SCC-MEE) and apply for approval. A certificate should be granted before any new chemical substance enters the China market, otherwise, relevant companies will be subject to severe penalties.

IECSC was last updated on December 27, 2023.

China New Chemical Substance Registration (China REACH) includes regular registration, simplified registration, record registration, and new usage management registration.

Regular Registration

Applicable Conditions

New chemical substances manufactured or imported in quantities at/above 10t/y.

Registration Bodies

• Manufacturers/direct importers of new chemical substances in China
• Overseas companies planning to import new chemical substances to China (designate a representative agent when applying for the registration)

Required Materials

• Regular registration application form
• Appendixes to the application form:
  • Legal person certificate or business license, representation contract or agreement, authorization letter
  • Testing report or data
  • Environmental risk assessment report
  • Socio-economic benefit analysis report (for highly hazardous new chemicals)
  • Materials stating the necessity of information protection (where one wishes to apply for protection of   identification information of chemicals)
  • Letter of commitment to implementing and passing on environmental risk control measures and environmental management requirements
  • Qualification of testing institutes
  • Other information already obtained by the applicant on the environmental and health hazard properties and environmental risks of the substance

Data Requirements

Process of Regular Registration

Registration Period

The registration period of record registration is 14~24 months.

Post-Registration Obligations

• Information Transmission
• Data Retention
• First Activity Report
• Annual Report
• New Hazard Information and Environmental Risk Tracking
• Accept Environmental Supervision and Spot Check

Related Information

Updated FAQs for China New Chemical Substance Registration

Our Services

• Representative Agent Service
• IECSC Comprehensive Search
• New Chemical Substance Simplified Registration
• Overall Registration Scheme
• Data Assessment/Data Gap Analysis/Exemption Analysis/PBT Properties Identification
• Non-testing Assessment Report (QSAR, Read-across)
• Test Monitoring
• Communication with Competent Authorities/Experts
• Translation for Registration Documents
• Post-registration Obligations
• Customized Training

Why Choose REACH24H

• Rich accumulation: Accumulated rich experience in dealing with global chemical regulatory compliance and technical consulting.
• Rich experience: Above 10-year practical experience in the field of China’s new chemical management regulation.
• Outstanding performance: As of December 2021, REACH24H has successfully submitted more than 3,000 applications under MEP Order No. 7, including dozens of high-tonnage difficult substances, and the pass rate is 100%.
• Strong technical strength: We have a team of above 30 senior technical personnel with academic and professional backgrounds in toxicology, analytical chemistry, chemical engineering, biology, pharmacology, environment, etc.