China has significantly changed how foreign chemical manufacturers can obtain market access for new chemical substances. Effective August 15, 2026, foreign enterprises are no longer being accepted as applicants for new chemical substance environmental management registrations. The previous arrangement—under which an overseas manufacturer or trading company could apply through a designated Chinese agent—is being replaced by a system centered on Chinese producers and importers.
The change has consequences extending well beyond regulatory paperwork. It may affect ownership of registration data, protection of confidential chemical identities, control over distribution channels, relationships with Chinese importers, and the ability of foreign manufacturers to change commercial partners.
Companies exporting chemicals, mixtures, polymers, or formulated products to China should evaluate the impact immediately.
What Changed in China?
Under China’s existing Measures for the Environmental Management Registration of New Chemical Substances, commonly called MEE Order No. 12 or “China REACH,” a chemical is considered new if it is not listed on the Inventory of Existing Chemical Substances in China (IECSC).
The current published version of Order No. 12 allowed an overseas manufacturer or trading enterprise intending to export a new chemical substance to China to act as the applicant. The foreign applicant was required to appoint an enterprise or institution established in China as its agent. The applicant and agent then shared registration and post-registration responsibilities.
China’s new regulatory direction removes this foreign-applicant model. The MEE’s proposed revised registration measures state that an applicant must be an enterprise or public institution legally registered in China, capable of independently assuming legal liability, and engaged in manufacturing or importing the new chemical substance.
In practical terms, the Chinese manufacturer or importer—not the foreign supplier or its appointed representative—must become the registration applicant and certificate holder.
Industry implementation reports indicate that, beginning August 15, 2026, the competent authority stopped accepting new applications and certificate-change applications submitted by enterprises outside China. The final replacement for Order No. 12 was not yet published as of August 18, 2026, so companies should continue monitoring MEE announcements and obtain advice for specific transactions.
China Also Eliminated the New Chemical Filing Pathway
The applicant restriction is part of a broader overhaul of China’s new chemical management program.
On August 4, 2026, China’s Ministry of Ecology and Environment published an official Notice on Matters Concerning the Environmental Management Registration of New Chemical Substances. The notice states that, effective August 15, 2026, MEE will no longer process new chemical substance filings.
Substances that previously qualified for filing—including certain substances imported or manufactured below one metric ton annually and qualifying polymers—must instead undergo an application and approval process modeled on simplified registration.
This means that companies face two important changes at the same time:
- Foreign enterprises can no longer rely on the former overseas-applicant and local-agent structure.
- Lower-volume substances that previously used the filing pathway are moving into a formal registration process.
The result is greater dependence on Chinese importers, additional administrative review, and potentially longer commercialization timelines.
Why the Applicant Restriction Matters
Loss of Direct Control Over Registration
When a foreign manufacturer holds a registration through an independent representative, it can generally supply multiple customers under the same regulatory asset, subject to the applicable rules. If the Chinese importer must instead hold the registration, the foreign manufacturer may become dependent on that importer for continued market access.
Changing distributors could require a new registration, certificate modification, or restructuring of the import arrangement. If several unrelated importers are used, separate registrations or coordinated applications may be necessary.
Confidential Business Information Concerns
New chemical registration frequently requires disclosure of sensitive information, including:
- Specific chemical identity
- Composition and impurity profiles
- Manufacturing or processing information
- Proposed uses and import volumes
- Toxicological and ecotoxicological data
- Environmental exposure information
- Risk-control measures
Foreign manufacturers may be reluctant to disclose this information directly to customers or distributors. Although confidentiality protections may be requested, placing the importer in the position of applicant creates additional questions about who can access the information, who owns the supporting data, and how the information can be used.
Companies should establish contractual controls before transferring confidential data. These controls may address data ownership, permitted uses, disclosure restrictions, cybersecurity, employee access, regulatory communications, and the return or destruction of information when the commercial relationship ends.
Increased Dependence on Individual Importers
A registration held by a Chinese importer can become commercially valuable. If the foreign supplier later wants to change importers, add distribution channels, or sell directly through a Chinese affiliate, the existing certificate may not provide the needed flexibility.
This may give the importer greater leverage over pricing, supply agreements, and market access. Foreign manufacturers should therefore evaluate an importer’s financial stability, compliance systems, technical capabilities, and long-term commercial alignment before allowing that importer to become the registration holder.
Possible Market-Entry Barriers
The restriction may disproportionately affect smaller and mid-sized foreign manufacturers that do not have a Chinese subsidiary. Establishing a local entity, selecting a qualified importer, negotiating data protections, and completing registration may make entry into China slower and more expensive.
These requirements could also limit competition if companies decide that protecting proprietary chemistry is more important than entering or remaining in the Chinese market.
How Does the Chinese Approach Compare with U.S. TSCA?
The United States also limits who may submit a Premanufacture Notice under the Toxic Substances Control Act. Under 40 CFR § 720.22, only manufacturers incorporated, licensed, or doing business in the United States may submit a notice for domestic manufacture. For imports, the principal importer is generally responsible for the submission.
Under TSCA, “manufacture” includes import. A company intending to import a new chemical for a nonexempt commercial purpose generally must submit a PMN to EPA at least 90 days before import begins. EPA explains these requirements on its PMN filing page.
However, U.S. customs rules provide a potential route for a non-U.S. company to operate as a nonresident importer. Under 19 CFR § 141.18, a nonresident corporation may enter merchandise for consumption if it:
- Maintains an authorized resident agent for service of process; and
- Files a customs bond with a resident corporate surety to secure applicable increased or additional duties.
A properly structured nonresident importer may therefore become the principal importer responsible for a TSCA PMN. This option involves customs, bonding, tax, recordkeeping, TSCA certification, and commercial considerations, so it should not be treated as a simple equivalent to appointing an Only Representative.
The key distinction is that the U.S. framework can allow a foreign company to assume importer responsibilities directly if it satisfies the applicable requirements. China’s new direction instead places the registration role with an enterprise or institution legally registered within China and actually engaged in production or import.
What Should Foreign Chemical Manufacturers Do Now?
Foreign companies supplying China should consider the following actions:
Review the Chemical Portfolio
Confirm whether each substance is listed on the IECSC and determine whether it is subject to new chemical registration. The review should cover pure substances, mixture components, polymers, intermediates, impurities with commercial significance, and substances used in formulated products.
Identify Affected Registrations and Filings
Determine whether existing registrations or filings were submitted in the name of a foreign entity. Review certificate ownership, approved uses, tonnage bands, importers, agents, confidentiality claims, and post-registration obligations.
Existing certificates may remain valid under transitional provisions, but changes to certificate information could trigger new requirements. Each certificate should be reviewed individually.
Select the Chinese Applicant Carefully
Potential applicants may include a Chinese subsidiary, an affiliated importer, a distributor, or a customer. The selected entity should have the legal authority, technical capability, and compliance infrastructure to fulfill both registration and post-registration duties.
Where possible, using a controlled Chinese affiliate may provide greater protection than relying entirely on an independent distributor.
Strengthen Contracts and Data Protections
Agreements with the Chinese applicant should clearly address:
- Ownership of registration studies and dossiers
- Confidentiality and information-security requirements
- Responsibility for application costs
- Use of the registration by additional customers
- Post-registration reporting and recordkeeping
- Access to regulatory correspondence
- Rights following termination or a change in importer
- Cooperation with certificate amendments or replacement applications
- Liability for noncompliance
Reassess Commercialization Timelines
Companies should allow additional time for importer selection, data-sharing arrangements, testing, dossier preparation, technical review, and regulatory approval. Substances that formerly qualified for filing may now require formal approval before production or import.
Conclusion
China’s restriction on foreign new chemical registration applicants represents a fundamental change in regulatory and commercial control. The issue is not simply who signs the application. It determines who holds the registration, who receives confidential information, who controls market access, and how easily a foreign manufacturer can change customers or distribution partners.
Foreign chemical manufacturers should review their Chinese supply chains before transferring registration responsibility to an importer. A coordinated strategy covering regulatory compliance, confidential business information, contractual rights, and long-term distribution plans can reduce the risk of losing control over valuable chemical and market-access assets.
How Experien Health Sciences Can Help
Experien Health Sciences assists chemical manufacturers and importers with global chemical regulatory strategy, inventory status reviews, new chemical notifications, toxicological data evaluation, and regulatory risk assessment. We can help companies evaluate the impact of China’s changing new chemical requirements, identify potential registration obligations, and develop a strategy that protects both compliance and confidential business information.
Contact Experien Health Sciences to discuss how these changes may affect your chemicals, import arrangements, or access to the Chinese market.
This article provides general regulatory information and is not legal advice. China’s implementing requirements remain under active development, and companies should confirm the current requirements before manufacturing or importing a new chemical substance.
Frequently Asked Questions
Can a foreign manufacturer register a new chemical directly in China?
Under the new regulatory direction implemented beginning August 15, 2026, foreign enterprises are no longer being accepted as direct applicants. The applicant must generally be an eligible Chinese producer or importer.
Can a foreign company appoint an Only Representative in China?
The former system allowed an overseas applicant to designate a Chinese agent. The revised approach removes the foreign applicant and agent structure. A Chinese importer or producer must instead act as the applicant and registration holder.
What happens to registrations already held by foreign companies?
The proposed transitional provisions indicate that existing registration certificates may remain valid. However, changes to certificate information or import arrangements may require a new application. Existing certificates should be reviewed individually as final implementing rules are issued.
Does the United States allow foreign companies to submit TSCA PMNs?
A foreign manufacturer generally cannot submit solely in its capacity as an overseas manufacturer. However, a nonresident company may potentially qualify as the U.S. principal importer if it satisfies applicable customs requirements, including maintaining a resident agent and filing the required customs bond.
Why does the change create intellectual property concerns?
The Chinese importer acting as applicant may require access to chemical identity, composition, testing, use, and exposure information. Without appropriate submission procedures and contractual protections, the foreign manufacturer may risk disclosing valuable confidential business information to a customer or distributor.
Need Assistance with Chemical Registration or Notification Requirements?
Whether you are preparing to introduce a new chemical, evaluating an existing substance, or responding to changing requirements in China, the United States, or another global market, Experien Health Sciences can help you develop an efficient, defensible compliance strategy.
Learn more about our Chemical Registrations & Notifications services, or contact us to schedule a consultation with our regulatory experts.
