MEE Order No. 12 Revision FAQ: Practical Questions from Overseas Companies

At a Glance: What Changes Matter Most?

On June 11, 2026, China's Ministry of Ecology and Environment released the public consultation notice and the Revision Draft for Public Comment for the Measures for the Environmental Management Registration of New Chemical Substances. Comments are due by July 12, 2026, and the draft proposes an implementation date of August 15, 2026.

The draft has not yet become the final rule. The following FAQ therefore focuses on proposed changes and practical planning questions for overseas companies, while the current framework remains available in MEE's existing MEE Order No. 12 and REACH24H's China REACH service page.

A. Scope, Exemptions and Product Categories

1. Why is MEE proposing to remove some exemption categories under the current MEE Order No. 12?

The official consultation notice explains that the revision is intended to implement the Ecological and Environmental Code and improve the environmental management registration system for new chemical substances. From a regulatory-risk perspective, the proposed removal of several product-law-based exclusions appears to reflect a shift toward substance-level environmental risk control and to better build a source-control mechanism.

Under the current framework, some products regulated by other laws or regulations may be treated as non-applicable or exempt. The draft revision would reduce this product-category-based boundary and require companies to assess whether new chemical substances contained in or used for those products still trigger environmental management registration obligations.

The draft does not provide a detailed policy rationale for every removed category. Companies should therefore treat this as a draft-position change and monitor final rules, implementation guidance and possible cross-departmental coordination mechanisms.

2. Do raw materials in finished products such as detergents, cosmetics or fertilizers need to conform to the revised rules?

Potentially yes, but the assessment should be made at the substance and supply-chain level, not only at the finished-product category level.

If a finished product, formulation or mixture imported into China contains a substance that is not listed in the IECSC and does not qualify for another exemption, the domestic importer may need to assess whether registration is required before import. The same logic may become relevant for products such as detergents, cosmetics, fertilizers, pesticides, food-related products and feed-related products if their previous product-law-based exclusions are removed in the final rule.

This does not mean every raw material in every finished product will automatically require registration. Companies should screen each ingredient or component against IECSC status, new-use environmental management status, actual import route, intended use and available exemptions.

3. Does the draft revision affect imported finished cosmetic products and IECIC-listed ingredients?

Cosmetic compliance and chemical substance environmental management serve different regulatory purposes. The Inventory of Existing Cosmetic Ingredients in China (IECIC) is not the same as the Inventory of Existing Chemical Substances in China (IECSC).

If the final revised Measures remove the current product-law-based exclusions, a cosmetic ingredient that is acceptable from a cosmetic regulatory perspective may still need to be checked against IECSC. If the ingredient is a new chemical substance under the draft framework and is imported into China as part of a finished formulation, the Chinese importer may need to assess whether new chemical substance registration is required before import.

For existing finished cosmetic products already on the market, companies should monitor whether MEE or other authorities issue transitional rules. At this stage, IECIC listing should not be treated as automatic “grandfathering” into IECSC.

4. Are products sold for research, testing or technical services in scope?

The draft revision proposes a non-applicable category for chemical substances used for scientific research and technical services, including testing, inspection, metrology and monitoring.

However, companies should not apply this exemption broadly to commercial supply. The exemption should be assessed based on the actual purpose, recipient, volume, contract wording, use control and whether the substance could be diverted to industrial production or product manufacturing.

Where a substance is sold as a commercial raw material, formulation ingredient or production input, companies should not assume that the research or testing exemption applies merely because some customers may use it for testing.

5. How should companies understand “new use” after the revision?

Under both the current framework and the draft revision, certain substances listed in IECSC may be subject to new-use environmental management. If such a substance is used outside the permitted use indicated in IECSC or related authority information, the activity may be managed similarly to a new chemical substance registration obligation.

The draft revision continues to treat IECSC new-use substances as part of the new chemical substance management scope. It also states that IECSC substances under new-use management used for purposes other than permitted uses should apply for registration for that new use.

Companies should check not only whether a substance is listed in IECSC, but also whether its listed status is associated with new-use restrictions. For confidential substances or unclear identities, formal confidential inquiry may be necessary.

B. Applicant Eligibility and Supply Chain Strategy

6. Can overseas or Taiwan-registered manufacturers continue to hold registrations through a Chinese local agent?

The draft revision states that the applicant should be an entity legally registered within the PRC, capable of independently assuming legal liability, and engaged in production or import of the new chemical substance. As drafted, overseas manufacturers, overseas exporters and agent-based representative applicants are not listed as eligible applicants.

For existing certificates obtained under previous rules, the draft transitional provisions indicate that certificates already obtained under former MEP Order No. 7 or current MEE Order No. 12 would remain valid after the new Measures take effect. However, if certificate items change, the holder should follow the revised rules and may need to reapply depending on the change.

For future exports after the revised rules take effect, a Taiwan-registered or other overseas manufacturer would generally need to work with the mainland China importer or a legally established mainland China entity that actually conducts import or production. Practical handling of existing certificate holder status and post-effect modification scenarios should be confirmed once MEE issues final implementation guidance.

7. Is a Chinese sales office, China subsidiary or affiliate enough to act as applicant?

A Chinese subsidiary may act as applicant only if it is an independent legal entity registered in China and is the actual domestic producer or importer involved in the regulated activity. A representative office or sales office without independent legal person status would not normally meet this requirement.

If the Chinese subsidiary imports the product itself, it may serve as applicant for the relevant imported substances, subject to other registration conditions. If imports are handled by separate third-party importers, distributors or customers, the subsidiary may not be able to cover those import activities unless the supply chain is restructured.

Foreign companies should map the importer of record, customs flow, contract flow, CBI ownership, data access and post-registration obligations before selecting the applicant.

8. Can branches or multiple importers use the same registration documents?

The answer depends on whether the “branches” are part of the same legal entity and whether the import activities are carried out under the same applicant.

If branch offices are not independent legal entities and the registered applicant remains the importer of record for the relevant activities, the same registration certificate may be used within the registered conditions, including substance identity, activity type, registered volume, use and risk control requirements.

If different branches or affiliates are separate legal entities, or if multiple unrelated importers conduct import activities independently, they should not assume they can rely on another entity’s registration. A joint registration strategy may be considered where the same substance is involved and conditions for joint submission are met.

9. Why would the draft no longer allow non-Chinese manufacturers to register via an OR-like model?

China’s system under MEE Order No. 12 is not identical to the EU REACH Only Representative model. The draft revision appears to place more emphasis on domestic legal accountability, local supervision and traceable enforcement.

By requiring the applicant to be a PRC-registered entity engaged in production or import, the authority can more directly supervise actual activities, post-registration information transmission, annual activity record reporting and implementation of risk control measures.

For overseas suppliers, the practical impact is that Chinese market access may require earlier coordination with importers, distributors or Chinese subsidiaries, together with stronger contractual arrangements for CBI protection, data sharing and post-registration responsibility allocation.

C. Registration Routes, Polymers and Transition

10. What happens to existing notifications and registrations? Will there be a transition period?

The draft transitional provisions propose that certificates already obtained under MEP Order No. 7 or MEE Order No. 12 would remain valid after the revised Measures take effect.

Applications already accepted under MEE Order No. 12 before the effective date could continue to be processed under current MEE Order No. 12 requirements.

For substances already handled through MEE Order No. 12 record notification, the draft proposes that applicants should apply for registration under the new Measures before December 31, 2026. Companies holding record notification receipts should therefore identify affected substances and prepare transition filings early.

11. What will happen to chemicals currently under record notification?

The draft revision proposes to cancel the record notification category. Existing record-notified substances would not simply continue under the same notification model indefinitely.

For substances that have been record-notified under current MEE Order No. 12, the draft requires the record-notified substances to obtain a registration certificate under the new Measures by December 31, 2026. The exact handling of record notifications previously submitted by foreign manufacturers through Chinese agents should be monitored closely, because the draft applicant eligibility provisions no longer include overseas exporters through representatives.

In practice, companies should prepare a transition plan that covers substance screening, revised applicant selection, data availability, CBI arrangements and whether the substance should move to simplified registration or regular registration under the draft structure.

12. How will polymer registration change compared with the current model?

New polymers remain regulated unless they are outside scope or qualify for an applicable exemption. The draft revision changes the label and structure of polymer pathways, the main change is the upgrade from the current notification procedure to an administrative registration procedure.

The most important change is that polymer record notification would no longer remain a notification category. Depending on annual volume and whether the polymer meets the current polymer record notification criteria, the substance may fall into simplified or regular registration under the draft structure.

13. What are the conditions for a chemical to be listed on IECSC under the draft?

The draft states that a new chemical substance with a regular registration certificate may be included in IECSC five years after the first registration. However, several categories would not be listed.

These include substances with cumulative national annual manufacture and import volume below 10 tonnes, substances subject to new-use environmental management, substances exempt from submitting specified testing and risk assessment materials, and substances whose regular registration certificates have been withdrawn or revoked.

This means that substances converted from certain low-volume or polymer notification-like routes may still not become ordinary IECSC-listed existing substances. Companies should not assume that every successful registration will lead to inventory listing.

14. What cost and lead-time points should companies consider without turning this FAQ into a registration service page?

Cost and lead time are highly case-specific and should be assessed through a dedicated registration pathway review rather than answered with a single generic figure.

For revision planning purposes, companies should note that the draft proposes technical review timelines of up to 20 working days for simplified registration and 45 working days for regular registration per round, with a 20-working-day supplementation deadline. The total project timeline can be much longer because it may include IECSC screening, data gap analysis, testing, dossier preparation, translation, CBI justification, applicant coordination and response to authority comments.

To avoid competing with the core service page, this FAQ should direct readers seeking cost, timeline and project quotation to the China REACH service page or a dedicated assessment form.

D. Data, Testing and Application Materials

15. What endpoints, reports and forms may be required? Are read-across or non-animal methods accepted?

The required data set depends on the registration type, annual volume, polymer status, hazard profile and whether the substance qualifies for a data exemption. Under the draft, regular registration materials may include physicochemical, toxicology and ecotoxicology test reports or data, an environmental risk assessment report, risk control measures and, for high-hazard substances, socio-economic benefit analysis materials.

For substances with national cumulative annual production and import volume below 10 tonnes, the draft exempts submission of the environmental risk assessment report and socio-economic benefit analysis materials. For low-concern polymers or polymers meeting the 2% rule, the draft may exempt specified testing and risk assessment materials if supporting proof is submitted.

Read-across, non-testing methods or non-animal approaches may be useful as supporting technical evidence where scientifically justified. However, they should not be treated as automatically accepted substitutes for required endpoints. Acceptance is endpoint-specific and should be assessed against current technical guidance, test method requirements and authority review practice.

Application forms and templates should be downloaded from the official MEE new chemical substance environmental management information system or the latest authority-issued guidance. Companies should avoid relying on old forms once the revised Measures and supporting documents are finalized.

16. What toxicity tests are mandatory and which test methods are used?

There is no one-size-fits-all mandatory test list applicable to every substance. Testing depends on the registration route, tonnage band, data exemptions, hazard concerns and whether existing data can support risk assessment.

For regular registration, the draft refers to physicochemical, toxicology and ecotoxicology testing reports or data. It also emphasizes that ecotoxicology testing reports should include data generated using test organisms from China in accordance with relevant standards.

Companies should design the testing strategy after completing substance identity confirmation, IECSC screening, tonnage estimation, use and exposure analysis, and polymer or exemption assessment. Early data gap analysis is especially important because the draft shortens the supplementation period to 20 working days.

17. Where should companies download the application forms for simplified and regular registration?

Companies should use the official MEE government service platform and the new chemical substance environmental management information system. The webinar materials identify MEE's online registration system as the main submission platform.

Because the draft changes registration category names and materials, companies should check for updated templates once the final Measures and supporting documents are published. Before publication, any form downloaded under current MEE Order No. 12 should be treated as current-rule material, not necessarily as final material for the revised system.

E. Post-registration Obligations, Information Transmission and CBI

18. How should companies understand and implement information transmission to new chemical substance users?

The intended concept is information transmission, not “information transformation.” The draft requires enterprises and institutions that produce, import or use new chemical substances to transmit relevant certificate information to downstream users through sales, entrustment and other contracts.

Information to be transmitted would include the registration certificate number, registered use or pollution risk control measures, and environmental management requirements stated on the certificate.

This means SDS-only communication may not be sufficient. Companies should consider updating sales contracts, toll manufacturing agreements, importer-distributor agreements, internal order controls and downstream customer communication procedures to reflect certificate conditions and use restrictions.

19. What activity records and annual reporting should companies prepare for?

The draft proposes that entities producing, importing or using new chemical substances should establish an activity record system and record activity time, quantity, use and implementation of pollution risk control measures and environmental management requirements.

The draft also proposes that activity records for the previous year should be uploaded to the new chemical substance environmental management information system by March 31 each year.

Overseas suppliers should coordinate with Chinese importers and downstream users because much of the activity data will be generated within China. Contractual allocation of reporting responsibility, data collection and audit rights should be considered before commercial supply.

20. How should companies manage confidential business information under the revised applicant model?

If overseas suppliers can no longer directly hold registrations through a representative, CBI protection becomes a more practical concern. The domestic applicant may need access to substance identity, composition, use, hazard data and other technical information.

The draft allows applicants to request protection for business secrets when submitting registration materials and requires justification for the protection request. However, companies should not assume all information will be protected automatically.

Foreign suppliers should prepare CBI strategies that may include data-sharing agreements, confidentiality clauses, limited disclosure packages, letter-of-access mechanisms, and clear responsibility allocation between overseas supplier, China importer and service provider.

Practical Action Checklist for Overseas Companies

• Screen all relevant substances against IECSC and check whether any listed substances are subject to new-use environmental management.

• Identify products previously treated as exempt, especially cosmetics, fertilizers, pesticides, food-related products and feed-related products, and conduct ingredient-level screening.

• Map the China supply chain and confirm the actual importer of registration or domestic production entity.

• Review existing MEE Order No. 12 record notifications and determine whether transition registration may be required before December 31, 2026.

• Reassess polymer eligibility under the draft registration structure.

• Conduct early data gap analysis; do not rely on last-minute supplementation after authority comments.

• Review CBI protection and data-sharing arrangements with Chinese importers or subsidiaries.

• Prepare post-registration systems for contract-based information transmission, activity record collection, annual upload and authority inspection response.

How REACH24H Can Support

REACH24H can support overseas companies in assessing how the MEE Order No. 12 revision may affect China market access and ongoing compliance. Relevant support may include:

• IECSC screening and confidential inventory inquiry support;

• applicability assessment for substances, formulations and product categories affected by the draft revision;

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

• record notification transition planning;

• polymer pathway assessment;

• data gap analysis and testing strategy;

• CBI protection strategy and dossier preparation support;

• post-registration information transmission and activity record system design.

For companies seeking a full registration pathway assessment, refer to REACH24H's China REACH service page or contact our chemical regulatory compliance team.

Recommended Reading

• China REACH: New Chemical Substance Registration under MEE Order No. 12

• China MEE Proposes Major Revisions to New Chemical Substance Registration Measures

• Revisions to Management of New Chemical Substances: What Overseas Cosmetic Brands Should Know

• Managing New Pollutants in China: Pollutant Regulations and Enterprise Compliance Strategies

• Regular Registration under China New Chemical Substance Registration

• Simplified Registration under China New Chemical Substance Registration

Official References

• MEE consultation notice on the draft revision of the Measures

• Draft revised Measures for the Environmental Management Registration of New Chemical Substances

• Compilation explanation for the draft revised Measures

• Current MEE Order No. 12: Measures for the Environmental Management Registration of New Chemical Substances

• MEE government service platform