2026.09.08 NI, Tianling (Carey Nee)、ZHU, He (George)、 WANG, Haopeng
I. Overview of Revision
In June 2026, the Ministry of Ecology and Environment released the Measures for the Environmental Management Registration of New Chemical Substances (Revised Draft for Comments) (‘the Draft Measures/ New Order No. 12’). The revision is intended to align with the Code of the People’s Republic of China on the Ecological Environment (CEE), which took effect on August 15, 2026, and is also a supporting institutional adjustment to implement the national action plan for the treatment of new pollutants. The revision restructures the registration management framework while tightening source controls, reinforcing enterprises’ primary responsibilities and adjusting the scope of application across industries. Sectors previously exempted, such as pharmaceuticals, food additives and cosmetics, are now largely brought within the regulatory scope and chemical, new materials and cross-border trading enterprises will see material changes in compliance costs and application procedures. As the final text has not yet been published, the following analysis is based on the Draft Measures and is intended to assist affected enterprises.
II. Five Core Highlights of This Revision
1. Abolishing the Low-Tonnage Record-Filing System and Replacing It with Two Registration Categories
Previously, where the annual manufacture or import volume was less than 1 metric ton, a simplified record-filing procedure was available. The Draft Measures abolish the record-filing channel altogether and require all substances to undergo administrative approval: regular registration for 1 metric ton or more and simplified registration for less than 1 metric ton. The application timeline and testing documentation requirements will increase substantially. Existing record-filings are subject to a six-month transition period, during which record-filing applicants must apply for and obtain a registration certificate by December 31, 2026, in accordance with the New Order No. 12.
2. Expansion of Industries Subject to Regulation
Categories such as pharmaceuticals, feed and food additives were previously eligible for registration exemptions. The Draft Measures remove these exemption provisions and retain exceptions only for a limited number of categories including scientific research, testing and other technical services and radioactive chemical substances and substances stored in special customs supervision zones that are exported in full without any processing. Synthetic cosmetic ingredients, novel food additives and pharmaceutical intermediates must all undergo new chemical substance registration, and cross-industry enterprises generally have compliance blind spots. The registration exceptions applicable to the relevant industries have fundamentally changed. This is not merely the addition of an administrative procedure; it means that compliance management must be brought forward and run through the product’s entire life cycle: determining substance attributes and the appropriate registration pathway at the R&D stage; preparing test data and completing technical reviews; and subsequently transmitting information, maintaining activity records and submitting ongoing reports. Any omission or loss of control over timing at any stage may affect the use of raw materials and product launches.
3. Tightening Eligibility Requirements for Domestic Registration Applicants
Only manufacturing/importing enterprises that are lawfully registered in China and are capable of independently assuming legal liability may act as applicants. Overseas brand owners and overseas agents may not file applications independently, and many foreign clients will need to restructure their previous agency arrangements.
4. Tightening Rules for Inclusion in the Inventory of Existing Chemical Substances in China (IECSC): Low-Volume Substances are No Longer Automatically Included
Under the previous rules, a substance was included in the IECSC five years after regular registration. Under the new rules, substances with a total annual volume (i.e., the aggregate of annual manufacture and import volumes nationwide) of less than 10 metric tons, polymers of low concern and other such substances cannot be included in the IECSC even five years after registration. Such substances will remain regulated as ‘new chemical substances’ in the long term, and subsequent production changes or capacity expansions will still require repeat applications.
5. Strengthening Post-Registration Supervision and Legal Liability
The Draft Measures specify in greater detail the circumstances for changes to, withdrawal of, and revocation of registrations, and strengthen life cycle tracking and reporting obligations. They also align the penalty provisions with the CEE, substantially increasing penalties for manufacturing or importing without a registration certificate. Specifically, the penalty provisions for core violations will uniformly refer to the CEE. For example, manufacturing or importing that fails to comply with registration certificate requirements, or the manufacturing or importing of new chemical substances without a registration certificate, will no longer be subject to the existing fine of RMB 10,000 to RMB 30,000; instead, the offender will be punished in accordance with the relevant provisions of the CEE and the maximum fine may reach RMB 2 million.
III. Practical Recommendations for Enterprises
1. Determine whether the enterprise’s business will be affected by this revision. Review the list of chemicals currently handled and classify them into three categories: existing record-filings, registered substances and substances not yet declared. Prioritize converting record-filings into registrations during the transition period to avoid application congestion at the end of the year.
2. For product segments such as pharmaceuticals, cosmetics and food additives, identify substances newly brought under control; establish a ‘substance-entity-quantity-use-certificate’ register; cross-check the IECSC by CAS number, composition and their Chinese and English names; and allow sufficient time for applications.
3. Review agency arrangements with overseas partners; adjust the entity responsible for the registration application; improve agreements allocating the rights and responsibilities of domestic enterprises; and avoid the invalidation of registrations due to non-compliant applicant status.
4. At the procurement stage, require suppliers to provide registration certificates, the use and control requirements stated in those certificates, and agree on systems for suspending supplies and seeking recourse where information is inaccurate or certificates become invalid. Retain records of manufacture, import and risk control and cooperate with routine onsite inspections by ecology and environment authorities.
5. In IPO, investment and financing scenarios, treat new chemical substance compliance as a production-continuity matter rather than a general item on an environmental checklist, and examine the historical record-filings, registration certificates, downstream information transmission, annual submissions and public records of the issuer or target enterprise and each of its subsidiaries. Hong Kong-listed and A-share-listed enterprises should improve the environmental sections of the ESG disclosures in their prospectuses, fully disclose their compliance with the new chemical substance registration requirements and mitigate any potential regulatory inquiry risks in advance.
If you would like to determine whether a substance falls within the regulations for new chemical substances, whether any exemption applies or how to complete the registration/record-filing, please contact us at ecoenvpro@junhe.com.
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