With the Ecological and Environmental Code of the People's Republic of China coming into force on August 15, 2026, China's environmental management registration system for new chemical substances has undergone a major adjustment. The Ministry of Ecology and Environment (MEE) has made it clear that the processing of environmental management filing for new chemical substances ceased as of that date, and all former filing matters have been fully transferred into the registration procedure. CIRS Group reminds you that the corresponding government service system completed the module switch on the evening of August 14, and that after the conversion from filing to registration, enterprises need to additionally provide the applied use information and a necessity statement for information protection when submitting registration materials.
1. Background: Order No. 12 Revision and Cancellation of the Filing Category
On August 4, 2026, the General Office of the MEE issued the Notice by the General Office of the Ministry of Ecology and Environment of Matters Concerning the Environmental Management Registration of New Chemical Substances (Letter No. 301 [2026] of the General Office of the Ministry of Ecology and Environment, hereinafter the "Notice"), specifying that, "in order to implement the Ecological and Environmental Code of the People's Republic of China and improve the environmental management registration system for new chemical substances", the processing of environmental management filing for new chemical substances will cease from August 15, 2026.
According to the Notice, enterprises and public institutions that meet the relevant filing requirements under the original Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12, hereinafter the "Measures") shall, before production or import, submit to the ecological environment competent department of the State Council an application form for the environmental management registration of new chemical substances, together with supporting materials demonstrating the corresponding circumstances specified in Paragraph 3 of Article 10 of the Measures, as well as other information already in their possession on the environmental and health hazard characteristics and environmental risks of the new chemical substance; the competent department will accept and approve such applications by referring to the simplified registration procedures and timelines.
The institutional background of this adjustment is that the Ecological and Environmental Code officially came into force on August 15, 2026. As the Code no longer retains a "filing" category, low-volume substances (with an annual production or import volume of less than 1 tonne) and qualifying polymers currently managed through filing will be brought under registration management in a unified manner. The cancellation of the filing category was already reflected in the draft revision of the Measures released for public consultation on June 11.
2. Registration System Switch: The Filing Module Has Become "Registration Application" since August 15
According to the MEE government service system, since August 15, 2026, the "Filing Application" module in the environmental management registration system for new chemical substances has completed the switch and been officially converted into "Registration Application". This means that the system no longer accepts filing submissions, and the application entry now uniformly leads to the registration procedure.
3. Documentation Changes After the Conversion: Added Use Information and Necessity Statement for Information Protection
The two registration types — (1) new chemical substances with an annual production or import volume of less than 1 tonne, and (2) polymers containing no more than 2% of new chemical substance monomers or reactants, or polymers of low concern — retain all of the data requirements of the original filing application. After the conversion from filing to registration, the main changes are the following four aspects:
First, overseas enterprises can no longer submit applications as registration applicants. Under the draft revision of the Measures released for consultation on June 11, the agent system has been removed, and overseas enterprises can no longer act as registration applicants. This is also intended to align with the relevant provisions of the Ecological and Environmental Code.
Second, after the conversion from filing to registration, one registration application form can only cover one new chemical substance. Under the original filing practice, a single set of application materials could cover multiple chemical substances, allowing enterprises to complete the filing compliance for dozens of new chemical substances at one time. After the conversion to the registration procedure, however, an applicant can only complete the registration compliance for one new chemical substance in each registration application.
Third, information on the use of the applied substance is added, and the applied use must be provided. After the conversion to registration, applications shall specify the applied use in accordance with the registration requirements. In fact, the Measures have already made clear that the items recorded in the registration certificate include the "applied use", and use information constitutes the basis for registration review and for the transmission of subsequent environmental risk control measures. For enterprises that previously went through the filing route, the provision of use information is a new requirement.
Fourth, where the protection of the chemical name and structural information of the applied substance is requested, supporting materials demonstrating the necessity of information protection must be provided. Under the Measures, where an applicant considers that the registration application materials it submits involve trade secrets and requests information protection, it shall make the request at the time of applying for registration and submit materials demonstrating the necessity of the requested trade secret protection. Therefore, after the conversion from filing to registration, enterprises intending to claim protection of information such as the chemical name and structure of the substance must submit the necessity statement together with the application; otherwise, the relevant information will be disclosed in accordance with the registration disclosure requirements.
Conclusion: The conversion from filing to registration means that low-volume new chemical substances that previously entered the market through the "lightweight" filing route will be brought into a more complete registration management chain. For enterprises, applications submitted after August 15 must not only enter through the registration portal and be processed under the simplified registration procedure, but also include, at the documentation level, the applied use and, where applicable, the necessity statement for information protection. Relevant enterprises are advised to promptly sort out the substances for which applications are in progress or planned, and to prepare use descriptions and information protection materials in advance, so as to ensure a smooth compliance transition.
The revision of the new chemical substance registration regulations is expected to be advanced and implemented rapidly, and enterprises involved in new chemical substance registration are advised to pay close attention. CIRS Group will continue to follow the revision of the relevant regulatory documents, provide clients with professional regulatory interpretation, and offer compliance consulting and optimal solutions for new chemical substances in China.
Please stay tuned to the CIRS Group official website and ChemRadar for professional regulatory analysis articles. You are also welcome to follow and attend the series of seminars on the revision of the new chemical substance regulations hosted by CIRS Group.
