Industrial Chemical

MEE Order No. 12 Draft Revision: How Existing Certificates and Record Notifications Would Transition

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China New Chemical Substance Compliance

On June 11, 2026, China's Ministry of Ecology and Environment (MEE) released a draft revision to the Measures for the Environmental Management Registration of New Chemical Substances. The proposal would replace the current three-pathway system under MEE Order No. 12 with regular and simplified registration, while introducing specific transition rules for existing credentials.

For companies already holding a registration certificate under former MEP Order No. 7 or current MEE Order No. 12, the draft's central message is that existing certificates would generally remain valid. By contrast, record notifications completed under MEE Order No. 12 would not simply continue indefinitely: the record-notification applicant would need to obtain a registration certificate by December 31, 2026.

Draft Revision      Legacy Certificates      Record-Notification Transition      China REACH

The proposal remains a draft. The MEE domestic consultation closed on July 12, 2026, while the international review under WTO notification G/TBT/N/CHN/1351/Rev.1 remains open until August 30, 2026. Although the draft proposes an effective date of August 15, 2026, companies should rely on the final published rule and implementing guidance before treating any proposed date or pathway as legally settled. For the current framework, see REACH24H's China REACH: New Chemical Substance Registration under MEE Order No. 12 service guide.

At a Glance: What Would Happen to Existing Credentials?

Key takeaway: Existing registration certificates and MEE Order No. 12 record notifications would follow different transition rules. Certificate validity would generally continue, whereas record notifications would require an affirmative registration application within the proposed transition period.

Existing Credential / SituationProposed TreatmentWhat to Verify
Registration certificate issued under MEP Order No. 7 or MEE Order No. 12Would generally remain valid after the revised Measures take effect.If any particular stated on the certificate changes, the holder would need to reassess the pathway and apply under the revised Measures. Final guidance should clarify how the legacy transition rule interacts with amendment procedures.
Record notification completed under MEE Order No. 12The record-notification applicant would need to obtain a registration certificate by December 31, 2026.Determine the new route by annual volume and polymer status; verify whether the applicant remains eligible under the proposed PRC-based applicant rule.
Registration application formally accepted before the revised Measures take effectCould continue to be processed under current MEE Order No. 12.Confirm that MEE has formally accepted the application. A system draft, initial upload or pending supplementation should not automatically be treated as formal acceptance.
MEP Order No. 7 research record or other historical research credentialNot expressly addressed by the Order No. 12 record-notification conversion clause; some future research activities may fall within the draft exclusion for scientific research and technical services.Do not discontinue existing controls based on the draft alone. Preserve evidence of purpose, volume and project status and await the final rule or guidance.

The Proposed Framework: From Three Pathways to Two

Current MEE Order No. 12 uses regular registration, simplified registration and record notification. The draft would remove record notification and divide registration solely by annual manufacture or import volume.

IssueCurrent MEE Order No. 12Revision DraftBusiness Impact
Registration pathwaysRegular registration, simplified registration and record notificationRegular registration and simplified registrationExisting records would need to move into a registration pathway.
Volume thresholdsRegular: 10 t/y or more; simplified: 1 to less than 10 t/y; record notification: generally less than 1 t/y or eligible polymersRegular: 1 t/y or more; simplified: less than 1 t/yNew projects in the 1–10 t/y range would move from simplified to regular registration.
ApplicantA PRC manufacturer or importer may apply; an overseas exporter may also apply through a qualified PRC agent. Certain downstream users may apply in specific cases.A PRC-registered entity able to independently bear legal liability and engaged in manufacture or importForeign applicant/agent models and some downstream-user pathways would need reassessment.
When activity may beginFor record notification, activity may begin after complete materials are submitted under the current rule.A registration certificate would be required before manufacture or import.The current timing advantage associated with record notification would disappear.

For a broader comparison of the proposed system changes, see China MEE Proposes Major Revisions to New Chemical Substance Registration Measures. The sections below focus specifically on how companies should interpret their existing credentials.

Two Timelines Could Determine Whether a Project Faces a Compliance Gap

1. Proposed effective date and pending applications

The draft proposes August 15, 2026, as its effective date and states that current MEE Order No. 12 would be repealed at the same time. It also provides that registration applications accepted under the current rule before the revised Measures take effect could continue to be processed under current MEE Order No. 12.

Companies with applications in preparation, supplementation or technical review should therefore confirm their actual procedural status. The relevant question is whether the authority has formally accepted the application—not merely whether materials have been uploaded or an internal dossier has been completed.

2. December 31, 2026 deadline for existing record notifications

Under draft Article 45, an applicant that completed record notification under MEE Order No. 12 would need to apply for and obtain the appropriate registration certificate by December 31, 2026. The draft does not provide for an automatic conversion of a record-notification receipt into a certificate.

Because the applicant eligibility rule would also change, overseas companies that currently rely on a foreign applicant plus Chinese agent arrangement should assess whether a qualified Chinese manufacturer or importer can act as the new applicant. The final rule or guidance will need to clarify the procedural mechanics for such legacy cases.

How Different MEE Order No. 12 Credentials Would Transition

Existing record notifications: route depends on volume and polymer status

For general substances with an annual manufacture or import volume below 1 tonne, the proposed route would be simplified registration. Eligible polymers would also be divided by volume: below 1 tonne would fall under simplified registration, while 1 tonne or more would fall under regular registration.

The draft contains a targeted data relief mechanism for eligible polymers applying for regular registration. A low-concern polymer, or a polymer in which the combined content of new chemical monomers or reactants does not exceed 2%, would be exempt from submitting the testing reports or data, pollution risk assessment report and—where relevant—socioeconomic analysis listed in draft Article 11. The applicant would still need to submit evidence demonstrating that the polymer meets the applicable conditions.

Accordingly, the transition is not a no-document exercise. For polymers, the compliance focus may shift from a standard testing package toward robust polymer characterization and a verifiable evidence chain. If confidential substance identification information requires protection, the draft would require the request and a necessity statement to be submitted with the registration application.

Current simplified registration certificates for 1–10 t/y: valid, but future actions move into the regular route

A simplified registration certificate already obtained under current MEE Order No. 12 would remain valid under the general legacy-certificate rule. However, a new application—or a reapplication triggered by a change to registered particulars—would be assessed against the revised thresholds. Because the draft places 1 tonne or more in regular registration, companies should not continue to plan such projects as simplified registrations.

For a regular registration where nationwide cumulative annual manufacture and import remain below 10 tonnes, draft Article 11 would exempt the pollution risk assessment report and the socioeconomic analysis for highly hazardous chemicals. The article does not itself exempt physicochemical, toxicology or ecotoxicology information. Companies should therefore wait for the final technical guidance before assuming a reduced testing package.

IECSC listing also requires caution. The draft would generally add a regularly registered substance to IECSC five years after first registration, but it excludes substances whose nationwide cumulative annual volume is below 10 tonnes, substances subject to new-use environmental management, substances benefiting from the specified polymer data exemption, and substances whose regular registration certificate has been withdrawn or revoked. A five-year anniversary alone would therefore not confirm inventory listing.

Current regular registration certificates for 10 t/y or more: validity continues, but IECSC status is not self-executing

Existing regular registration certificates would also remain valid. If a stated certificate item changes, the holder would need to reassess whether a new application is required under the revised Measures. For a new or materially changed regular registration project, the draft would require the application form, relevant physicochemical, toxicology and ecotoxicology information, a pollution risk assessment report and appropriate risk-control measures. A socioeconomic analysis would also be required for a highly hazardous chemical.

Companies approaching the five-year point should treat IECSC listing as an administrative status to monitor rather than an internal automatic conversion. They should verify the first registration date, nationwide activity volume, new-use management status, any polymer exemption and the validity of the certificate, then track MEE's official IECSC announcements.

How Legacy MEP Order No. 7 Credentials Should Be Reviewed

Draft Article 44 states that registration certificates issued under former MEP Order No. 7 would remain valid. However, Order No. 7 certificates and records were issued under different historical conditions, so companies should review each credential against its original scope, validity period, use and volume.

Order No. 7 CredentialPreliminary Reading of the DraftCompany Check
Research record (<0.1 t/y for scientific research)The draft excludes chemicals used for scientific research and certain technical services from its scope, so future activity may fall outside the revised Measures.The transition treatment, evidence requirements and boundary of the exclusion are not yet clear. Do not stop existing compliance controls based on the draft alone.
Regular notification certificate (generally ≥1 t/y)Certificate would remain valid.Monitor official IECSC additions; do not infer inventory status from historical age alone.
Basic simplified notification certificate (<1 t/y)Certificate would remain valid.If certificate particulars change, reassess whether simplified or regular registration applies under the revised thresholds.
R&D special simplified notification (<10 t/y; up to two years)Certificate would remain valid subject to its historical conditions.Confirm the first-activity date and whether the two-year validity period has already expired.
Scientific-research simplified notification (0.1–1 t/y)Certificate would remain valid; future qualifying research activity may fall within the proposed research exclusion.Retain purpose, quantity and project evidence and wait for final clarification.
Intermediate or export-only simplified notification (<1 t/y)Certificate would remain valid.Reassess the route if any stated certificate item changes.
Eligible polymer simplified notificationCertificate would remain valid.For a change or new application, apply the revised volume thresholds and substantiate eligibility for any polymer data relief.

For practical questions on applicant eligibility, polymers, record-notification transition and post-registration duties, see REACH24H's MEE Order No. 12 Revision FAQ for Overseas Companies.

Post-Registration Systems May Also Need to Change

The draft is not limited to pre-market registration. If adopted, it would make supply-chain information transfer and activity records more explicit. Companies should prepare to operationalize these requirements rather than treating the registration certificate as the end of the compliance process.

  • Contract-based information transfer: manufacturers, importers and users would need to transmit the registration certificate number, registered uses and other pollution risk-control measures, and environmental management requirements through sales, entrustment and other relevant contracts.

  • Annual activity-record upload: relevant entities would need to record activity dates, quantities, uses and implementation of control measures, then upload the previous year's records to the new chemical substance information system by March 31 each year.

  • First-activity report: holders of regular registration certificates would need to report the first manufacture, or the first import and transfer to a user, within 60 days.

  • Public disclosure: manufacturers and users of regularly registered new chemical substances would need to disclose implementation of pollution risk-control measures and environmental management requirements through a website or another publicly accessible channel.

Five Actions Companies Can Take Now

  1. Build a complete credential inventory. List each substance, certificate or record number, governing rule, applicant, agent, first-activity date, registered volume, use, polymer status, CBI status and IECSC status.

  2. Run a four-dimensional review of every MEE Order No. 12 record notification. Map annual volume, proposed applicant, polymer eligibility and CBI needs to the expected registration route.

  3. Confirm the procedural status of pending applications. Obtain evidence of formal acceptance and identify projects that may otherwise fall into the revised system.

  4. Update contracts and recordkeeping processes. Prepare clauses for downstream information transfer and a traceable system for activities by substance, batch, use and downstream destination.

  5. Monitor the final rule and implementing guidance. Revalidate proposed dates, applicant arrangements, data requirements, research exclusions, CBI procedures and IECSC treatment immediately after official publication.

How REACH24H Can Help

REACH24H supports overseas manufacturers, exporters, Chinese importers and multinational groups in assessing how the proposed MEE Order No. 12 revision may affect existing credentials, China market access and ongoing compliance. Relevant support may include:

  • IECSC screening and substance-portfolio mapping;

  • transition assessment for existing certificates, record notifications and polymers;

  • applicant and supply-chain strategy for Chinese manufacturers, importers, subsidiaries and distributors;

  • data-gap analysis, testing strategy and laboratory coordination;

  • CBI strategy, dossier preparation, submission and authority communication where applicable; and

  • post-registration contract, information-transfer, activity-record and reporting system support.

Plan the Right Transition for Your Existing Credentials

Need to determine how an existing MEE Order No. 7 or Order No. 12 credential should transition? 

Recommended Reading

Official Resources

Disclaimer: This article provides a general interpretation of publicly available regulatory materials and does not constitute regulatory advice for a specific substance, use or project. The applicable pathway, data requirements and availability of exemptions should be confirmed against the final published rule, implementing guidance and project-specific requirements.

REACH24H China REACH Compliance Team

Written by

REACH24H China REACH Compliance Team

The REACH24H China REACH Compliance Team has over 15 years of in‑depth regulatory compliance experience and includes four certified Chinese toxicologists. We maintain close and long‑standing communication channels with the Ministry of Ecology and Environment (MEE). Our technical experts have been invited to the Solid Waste and Chemicals Management Center (SCC) to deliver special sharing sessions on non‑testing approaches, covering the principles, scopes of application, and practical case studies of QSAR and Read‑Across methodologies.