CHINA REACH REGULATORY INSIGHT
On August 21, 2026, the Solid Waste and Chemicals Management Center of China's Ministry of Ecology and Environment (MEE-SCC) published FAQ Series 12, clarifying the evidence expected for polymer applications under the current interim Registration Application route. The FAQ addresses polymer naming, monomer and reactant information, molecular-weight distribution, exclusion criteria, cationic polymers, and degradation or stability evidence.
The clarification is particularly relevant to overseas polymer manufacturers and exporters working with China-based importers. It provides a more specific technical basis for preparing polymer dossiers and responding to authority questions during review.
Key takeaway:
For polymer projects, eligibility cannot be supported by form entries alone. The application should align substance identity, synthesis information, molecular-weight evidence, exclusion analysis and use-related stability or degradation evidence.
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Why Is the Interim Application Route Being Used?
MEE stopped processing new chemical substance record notifications on August 15, 2026. Under Notice on Matters Concerning the Environmental Management Registration of New Chemical Substances (Huanban Guti Han [2026] No. 301; unofficial English title), projects that would previously have met the record-notification conditions in Article 10, Paragraph 3 of MEE Order No. 12 must now use the interim Registration Application route before manufacture or import. The application is reviewed by reference to simplified-registration procedures and time limits, and submission alone does not authorize the activity to begin.
For a broader explanation of the change and the current online system, see China Ends New Chemical Record Notifications: Interim Registration Application Route Now Live.
Where Is the Application Filed?
Applications are filed through the MEE Government Service Hall. Under “New Chemical Substances,” applicants should open Item 13002 and use the dedicated “Registration Application” module. The former Record Notification history list and supplementation functions should not be used for a new project.
Six Polymer Dossier Requirements Clarified by MEE-SCC
1. Use Compliant and Consistent Polymer Names
The Chinese chemical name should follow the polymer-naming rules in the Guidelines for Environmental Management Registration of New Chemical Substances (MEE Announcement No. 51 of 2020) and HJ 1357-2024, Specifications on Environmental Management Registration of Chemical Substances.
The English name should follow International Union of Pure and Applied Chemistry (IUPAC) or Chemical Abstracts Service (CAS) naming rules, and the Chinese and English names should be consistent. Trade names, common names and abbreviations cannot replace the polymer's chemical name; they may be entered in the “Other Names” field.
2. List All Monomers and Reactants Involved in Synthesis
The monomer/reactant list should cover every monomer and reactant participating in polymer synthesis. This includes substances that do not appear in the chemical name and reactants that participate in the reaction but are not incorporated into the final polymer structure.
For each monomer and reactant, applicants should provide a standardized chemical name and CAS Registry Number, where applicable. The reported content should reflect the feed weight ratio or feed weight percentage of each monomer or reactant.
3. Provide Molecular-Weight Distribution Evidence
A polymer application should include a molecular-weight distribution profile, such as a gel permeation chromatography (GPC) result or another result capable of characterizing the polymer's molecular weight and distribution.
GPC is not the only possible route. If GPC testing cannot be performed, another suitable characterization result may be submitted. If the polymer’s inherent properties prevent experimental determination of its molecular-weight distribution, the final product's molecular weight may be reasonably estimated from the reaction mechanism, provided that the complete estimation process is documented.
4. Use Objective Evidence to Address Polymer Exclusion Criteria
A statement that a polymer does not fall within an exclusion category must be supported by objective evidence. MEE-SCC identifies the polymer's molecular structure, intended use and application scenario, test data and research literature as relevant evidence sources.
Unsupported declarations such as “the substance is not a cationic polymer” or “the substance is not degradable or unstable” are not sufficient by themselves. Applicants should show how the available evidence supports each conclusion.
5. Assess Cationic Polymers and FGEW Carefully
Cationic polymers, and polymers expected to become cationic in the natural aquatic environment, would generally require regular or simplified registration. However, the FAQ states that a current Registration Application may be possible where either of the following conditions is met:
the polymer is solid, is neither soluble nor dispersible in water, and is used only in the solid phase; or
the polymer has a low cationic density, with a functional group equivalent weight (FGEW) of at least 5,000 daltons.
For the first condition, the explanation may draw on the polymer’s physical state, water solubility, dispersibility and manner of use. For the second, FGEW may be calculated from the polymer's representative structure. FGEW refers to the molecular weight of polymer corresponding to one cationic functional group, or the ratio of number-average molecular weight to the number of cationic functional groups in the polymer structure.
Meeting one of these descriptions should not be treated as automatic acceptance. The conclusion and supporting calculation or evidence remain subject to authority review.
6. Explain Degradation or Stability in the Relevant Exposure Context
Degradation or stability evidence should be linked to the polymer's structure, intended use, application scenario and manner of use. Applicants should evaluate the potential environmental exposure under the relevant influencing factors and provide applicable degradation or stability test data or research reports.
The explanation should connect the evidence to the actual exposure scenario rather than presenting isolated test results or a general conclusion without supporting analysis.
Practical Pre-Submission Checklist
Before filing, overseas suppliers and their China supply-chain partners should align the regulatory pathway, technical evidence and data-transfer arrangements:
confirm whether the polymer itself is listed in the Inventory of Existing Chemical Substances in China (IECSC);
confirm the applicable pathway based on annual volume, polymer status, the 2% criterion, low-concern-polymer criteria and any exclusion conditions;
confirm the China-based applicant and determine whether confidential information should be submitted through an independent third party under the current system;
align Chinese and English names, CAS information, structural information, monomer/reactant data and feed ratios across the application and technical reports;
prepare GPC or other molecular-weight distribution evidence, or a fully documented estimation where experimental measurement is not feasible;
prepare objective evidence addressing applicable polymer exclusions, cationic characteristics, degradation and stability;
align intended-use information, confidential-information protection materials and responsibilities for responding to authority questions with the online form.
Current-route caution:
Do not use the former immediate-receipt model, Record Notification history-list workflow or 3–10-working-day filing expectation for a new project. Historical functions may remain relevant only to previously completed records or authority follow-up, subject to current system instructions.
How REACH24H Can Help
REACH24H supports overseas polymer suppliers and China importers in preparing for the current application route. Polymer-specific support may include:
polymer pathway and eligibility assessment based on annual volume, the 2% criterion, low-concern-polymer criteria and applicable exclusions;
review of substance identity, monomer/reactant information, molecular-weight distribution evidence, FGEW calculations and stability or degradation support; and
coordination of China-applicant, confidential-information and third-party submission arrangements for the polymer dossier.
For a targeted China REACH assessment, companies may provide the polymer identity, annual volume, monomer/reactant information, intended use and available technical reports.
Need a targeted China REACH polymer assessment?
Companies may provide the polymer identity, annual volume, monomer/reactant information, intended use and available technical reports for a targeted China REACH assessment.
Recommended Reading
China Ends New Chemical Record Notifications: Interim Registration Application Route Now Live
China REACH: New Chemical Substance Registration under MEE Order No. 12
