China REACH and R&D: When Does Order No. 40 Require Registration?

R&D Registration Under MEE Order No. 40

China's Ministry of Ecology and Environment (MEE) promulgated Order No. 40 on 24 October 2026. The revised Measures for the Environmental Management Registration of New Chemical Substances took effect on promulgation and repealed MEE Order No. 12.

REACH24H's reading of the adopted text is that removing "research" as a separately listed activity does not establish a general R&D exemption. The following scenarios explain how the manufacturing, importing and follow-up provisions apply; the boundary for purely exploratory laboratory work may require further clarification.

Three R&D Scenarios to Assess

Using a lawfully supplied substance in laboratory work

A research institution that only uses a lawfully supplied substance for experiments, analysis or testing would generally not incur a new registration obligation merely because it conducts research. It should confirm the substance's status in the Inventory of Existing Chemical Substances in China (IECSC) or its registration status, whether the intended use is covered, and any applicable new-use environmental management requirements.

Where applicable, obtain the certificate number, registered use, hazard information and environmental risk-control information from the supplier. If the intended research use falls outside the certificate conditions, the certificate holder should assess the change procedure before the new use begins.

Articles 32 and 33 distinguish re-registration for specified changes to regular registrations before inventory inclusion from certificate amendments and changes requiring a higher registration category. A use change should not automatically be treated the same way for every certificate type.

Laboratory use must also be distinguished from regulated "processing and use." Article 46(3) includes production or business activities such as repackaging, formulation and manufacture using new chemical substances. A research institution undertaking those activities may have obligations as a processor/user.

Synthesising substances and moving to pilot production

An R&D label does not exclude an activity that constitutes manufacture. Pilot production, scale-up, continuous preparation and preparation for product development or commercialisation should be assessed for manufacturing registration requirements. Where the activity constitutes manufacture of an in-scope new substance, the applicable certificate must be obtained before manufacture begins.

In contract manufacturing, the actual manufacturer will generally be the relevant manufacturing applicant under Article 11. The commissioning party should clarify registration responsibility and certificate details in the contract; contractual arrangements do not replace the statutory requirements.

Whether a purely exploratory laboratory reaction constitutes manufacture requires a fact-specific assessment. Where the boundary is unclear, REACH24H recommends seeking clarification from the competent authority before starting, rather than assuming that the laboratory setting removes the obligation.

Importing research samples or reference materials

Importing an in-scope new chemical substance for research or use as a reference material remains an importing activity. A small shipment is not automatically exempt. For example, a China-based institution purchasing a new catalyst sample from overseas must assess import registration requirements even if the material will be used only in its laboratory.

Before shipment, confirm the substance's identity, inventory status, applicable exclusions, annual import quantity and registration coverage. The Article 2 customs-area exception requires storage within a customs special supervision area followed by export in full without processing; it should not be assumed to cover imports for laboratory use in China.

What Changed Under Order No. 40

Under the former Order No. 12, Article 2 listed research, manufacture, import, processing and use. Order No. 40 lists manufacture and import in that provision. It nevertheless retains obligations for processors/users elsewhere in the measures.

Research was not an independent registration category under Order No. 12. Removing references to research and researchers does not remove the manufacturing or importing duties that may arise within a research project. Article 8's encouragement of scientific research is also not an exemption.

For applicant eligibility, existing certificates and historical filings, see REACH24H's broader guide to MEE Order No. 40.

The Consultation Draft Proposed a Different Exemption

The June 2026 consultation draft proposed excluding chemicals used for scientific research and technical services such as inspection, testing, metrology and monitoring. That proposed exclusion was not retained in the adopted measures. Descriptions of the draft cannot therefore establish a research exemption under current Order No. 40.

Check Substance Status and the Registration Route

Article 3 generally defines a new chemical substance as one not listed in the IECSC. Inventory listing does not necessarily remove all registration obligations: substances subject to new-use environmental management require assessment under the applicable conditions.

Article 34 distinguishes high-hazard substances from substances with specified combinations of persistence, bioaccumulation and toxicity. For high-hazard substances, it covers a change of use by the certificate holder or industrial use by another party. For the other specified substances, it covers industrial uses outside the permitted uses. Assess the substance category, actor and proposed use together.

Article 2's product exclusions and exceptions must also be checked. They address specified products, radioactive substances and the customs-area scenario described above, with qualifications for other industrial uses, raw materials and intermediates. They do not establish a general exclusion for research chemicals.

For new applications, Article 10 sets the following routes:

• Regular registration: annual manufacture or import of 10 tonnes or more.

• Simplified registration: annual manufacture or import of at least one tonne but less than 10 tonnes.

• Formality registration: annual manufacture or import below one tonne, polymers containing no more than 2% new chemical substance monomers or reactants, or polymers of low concern.

The applicable certificate must be obtained before the manufacturing or importing activity begins. Existing certificates and historical filings should be assessed separately against their scope and the applicable transition arrangements.

Follow-up Duties Depend on the Institution's Role

A research institution that manufactures or imports a substance and holds its certificate must assess the duties attached to that role. Research purpose does not remove them.

Article 42 does not expressly exclude formality certificate holders from first-activity reporting. Practical reporting arrangements should be checked against subsequent official guidance and the registration system.

An institution conducting only laboratory research use is no longer subject to dedicated follow-up duties merely as a "researcher." Article 40's recordkeeping requirement targets registered manufacturers and importers. Institutions qualifying as processors/users must still consider Articles 39, 43 and 44, including access to supplier information, new-hazard reporting and regulatory supervision.

Separate environmental duties remain. Article 644 of the Ecological and Environmental Code addresses chemical manufacture, import, storage, transport, sale, use and disposal. Article 527 requires lawful management of laboratory solid waste, including hazardous-waste management where applicable.

Penalties for Unregistered or Non-conforming Activities

Order No. 40 has no separate legal-liability chapter. Articles 1206 and 1207 of the Code address manufacture or import contrary to certificate requirements, manufacture or import without the required certificate, and using new substances manufactured or imported by an entity without the required certificate to manufacture products.

Violations can result in an order to correct and fines of RMB 200,000 to RMB 1 million. Refusal to correct can result in RMB 1 million to RMB 2 million, together with production restrictions or suspension for rectification. Serious cases may lead to suspension of business or closure, subject to the required approval.

Five Questions Before the Project Begins

1. What is the substance's status? Confirm identity, IECSC listing and any applicable new-use requirements.

2. Does the project involve manufacture or import? Separate domestic laboratory use from synthesis, pilot production, scale-up, contract manufacturing and direct import.

3. Which registration route applies? Check the planned annual manufacturing or import quantity and any qualifying polymer conditions.

4. Does existing registration coverage match the project? Review the use, activity type, quantity and risk-control measures, including any amendment or re-registration requirements.

5. Who is responsible when a partner supplies or produces the substance? Identify the manufacturer/importer, confirm registration coverage and arrange access to certificate and risk-control information.

Check subsequent implementing guidance when planning activities near the boundary between exploratory laboratory research and manufacture.

How REACH24H Can Help

REACH24H supports overseas suppliers and China-based businesses with:

• IECSC screening

• Registration pathway assessment

• Applicant strategy

• Data-gap analysis

For an R&D project, the assessment can begin with the substance identity, intended use, annual quantity and proposed manufacturing or importing arrangement.

Recommended Reading

• China REACH: MEE Order No. 40 Explained for Overseas Chemical Suppliers

• Earlier analysis: MEE's June 2026 consultation draft (draft-stage background; consult the adopted Order No. 40 for current requirements).

Official References

• MEE Order No. 40 adopted measures (Chinese)

• MEE Order No. 12 former measures (Chinese; historical reference)

• June 2026 consultation draft and accompanying documents (Chinese; draft-stage reference)

• Ecological and Environmental Code (Chinese)