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China's New Chemical Substance Registration: 4 Key Changes When "Filing" Becomes "Registration"

release time:2026-08-15 00:00:00 view count:5 times

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On August 15, 2026, significant changes to China's new chemical substance registration system officially took effect. With the Ecological Environment Code no longer retaining the "filing" (备案) category, low-volume substances those with annual production or import volume below 1 tonne and qualifying polymers that were previously managed through the filing mechanism are now uniformly brought under registration management.

According to the Ministry of Ecology and Environment (MEE) Government Service System, as of August 15, 2026, the "Filing Application" module in the New Chemical Substance Environmental Management Registration System has been switched over and formally converted to "Registration Application." This means the system no longer accepts filing submissions; all application entry points now uniformly direct to the registration process.

< Issue & Focus>

. 4 Key Changes in Application Materials

. Key Takeaways for Industry

Ⅲ. Looking Ahead

I. 4 Key Changes in Application Materials

For both registration types (1) new chemical substances with annual production or import volume below 1 tonne, and (2) polymers with monomer or reactant content not exceeding 2% or classified as low-concern polymers all original material requirements from the filing stage are retained. The most significant changes after the transition fall into four areas:

1.  Overseas enterprises can no longer act as registration applicants

In the Measures for the Environmental Management Registration of New Chemical Substances (Revised Draft for Comments) published on June 11, the agent system has been abolished, and overseas enterprises can no longer serve as registration applicants. This change aligns with the relevant provisions of the Ecological Environment Code.

2.  One registration application form covers only one new chemical substance

Under the previous filing system, a single application could cover multiple chemical substances, allowing companies to complete filing compliance for dozens of new chemical substances at once. Under the registration process, however, applicants can only complete registration compliance for one new chemical substance per application.

3.  New requirement: substance use information must be provided

After the transition, applications must clearly state the intended use in accordance with registration requirements. The Measures already specify that "intended use" is a required item on the registration certificate, making use information the foundation for registration review and the subsequent transmission of environmental risk control measures. For companies that previously used the filing channel, supplementing use information is a new compliance obligation.

4.  Confidentiality claims for substance names and structures require justification

Under the Measures, applicants who believe their registration application materials contain trade secrets and request information protection must raise the request at the time of application and submit materials justifying the necessity of trade secret protection. Companies seeking to protect information such as chemical substance names and structures must therefore submit a necessity statement together with their application; otherwise, the relevant information will be disclosed in accordance with registration publicity requirements.

II. Key Takeaways for Industry

The conversion from filing to registration means that low-volume new chemical substances that previously entered the market through "lightweight filing" will now be integrated into a more complete registration management chain. For companies, applications submitted after August 15 must not only use the registration entry point and follow the simplified registration approval process, but also supplement application materials with:

l Intended use information for each substance;

l A necessity statement for information protection (where applicable).

We recommend that relevant companies promptly review substances with applications in progress or planned, prepare use descriptions and information protection materials in advance, and ensure a smooth compliance transition.

III. Looking Ahead

The revision of the new chemical substance registration regulatory framework is expected to advance and be implemented rapidly. Companies involved in new substance registration are advised to monitor developments closely.

 

#ChemicalRegulation  #ChinaRegulation  #NewChemicalSubstances  #EnvironmentalCompliance  #MEE  #SupplyChain  #ChemicalIndustry  #RegulatoryAffairs  #REACH

Compliance is not a costit is a competitive advantage. For further information on these revisions, please contact Compliance Menmaking complex compliance simple.

 

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