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.
China New Chemical Substance Registration (China REACH) includes regular registration, simplified registration, record notification, and new usage management registration.
This article provides a practical guide to record notification, covering applicable conditions, notification bodies, required materials for both general substances and polymers, data expectations, the streamlined process and short timelines (typically 3–10 working days), as well as post-notification obligations. It aims to help enterprises efficiently navigate this simplified regulatory route and ensure smooth entry of new substances into the Chinese market.
Applicable Conditions of Record Notification
Record Notification of General Substances: New chemical substances manufactured or imported with an annual volume of less than 1 ton;
Record Notification of Polymers: (no upper volume limit) Polymers containing less than 2% (w/w) monomers or reactants which are new chemical substances, Or polymers of low concern (PLC).
Notification 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 Notification)
Required Materials for Record Notification
| Required Materials Items | Record Notification of General Substances | Record Notification of Polymers |
| Application Form | √ | √ |
| Legal Person Certificate or Business License | √ | √ |
| Agent contract or agreement (for Overseas Applicant) | √ | √ |
| Power of Attorney (if necessary) | √ | √ |
| Polymer Information (monomer/reactant information, molecular weight distribution map (such as GPC Report), polymerization mechanism process, etc.) | - | √ |
| Exclusion materials for record notification of polymers | - | √ |
| Other information already obtained by the applicant on the environmental and health hazard properties and environmental risks of the substance | √ | √ |
Note: If the polymer is less than 1 ton/year, the materials required for general substance filing can be submitted.
Data Requirements
Record notification of general substances: no data requirements.
Record notification of polymers: it is recommended to prepare the data of polymer stability (including oxidation, hydrolysis, heat, light, solvent or microorganism) and water absorption (when Mn is greater than 10000 Da).
Process of Record Notification
Notification Period
The registration period of record registration is 3~10 workdays.
Post-Notification Obligations
Information Transmission
Data Retention
New Hazard Information and Environmental Risk Tracking
Accept Environmental Supervision and Spot Checks
Related Information
Our Services
Representative Agent Service
IECSC Comprehensive Search
New Chemical Substance Record Notification
Identification of Polymer
Polymer-related Testing (such as Stability and Water Absorption) Scheme and Supervision Services
Communication with Competent Authorities/Experts
Translation for Literature and Notification Documents
Post-Notification Obligations Assistance
Why Choose REACH24H
Internationalized service: Our customer service team consists of personnel capable in English, Chinese, Japanese, Korean and German to efficiently serve multi-national customers.
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.
If you have any questions in this regard, please feel free to contact us at customer@reach24h.com.
