China's MEE Adds 486 Substances to IECSC: Analysis & Regulatory Requirements

On August 4, 2026, China's Ministry of Ecology and Environment (MEE) published Announcement No. 40 of 2026, officializing the addition of 486 chemical substances to the Inventory of Existing Chemical Substances in China (IECSC). Coming alongside ongoing revisions to the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12), this large-scale expansion carries major compliance implications for manufacturers, importers, and downstream users.

Overview of the Supplementation

This announcement contains two attachments:

Attachment 1 contains 4 chemical substances, all of which had been produced, sold, processed, used, or imported in China before the implementation of the new chemical substance environmental management registration system (before October 15, 2003). According to the announcement, these 4 substances are the "2025 Batch 2 (Total Batch 14) chemical substances proposed for supplementation into the Inventory of Existing Chemical Substances in China" that were publicized on August 11, 2025. Their identification information is fully public, and no permitted or new-use environmental management scope has been set.

Attachment 2 contains 482 chemical substances, all of which are new chemical substances that obtained regular registration certificates under the Measures for the Environmental Management of New Chemical Substances (former Ministry of Environmental Protection Order No. 7). They have been proactively listed in the Inventory by the competent authority after five full years from the implementation date of the Measures for the Environmental Management Registration of New Chemical Substances (Order No. 12). With this supplementation, all new chemical substances that obtained regular registration certificates under Order No. 7 have now been included in the IECSC.

It should be noted that among the 482 substances supplemented this time that obtained regular registration under Order No. 7, 40% have been assigned a permitted use / new use environmental management scope. If a company plans to use such substances for other industrial uses beyond the permitted uses, it must obtain a new chemical substance registration certificate for the intended use.

To help companies better understand the content of this Inventory supplementation, focus on its potential impact on their chemical-related activities, and prepare response strategies, CIRS Group has conducted a dedicated analysis of the 482 substances supplemented that obtained regular registration under Order No. 7.

Overall Statistical Analysis of the 482 Substances

According to the statistics, 88.2% of the substances supplemented in this batch have publicly disclosed identification information, of which 77% carry CAS numbers, indicating a relatively high level of transparency. This makes it easier for companies to determine whether the chemical substances they produce or import have already been included in the IECSC. Confidential substances are concentrated among organic substances (49 of the 57 confidential substances are organic) and polymers (8). Among the 111 substances without CAS numbers, 54 are non-confidential; these substances still appear in the form of "no CAS number" under their public chemical names, mainly corresponding to complex reaction products, polymers, and naturally modified derivatives that are difficult to uniquely identify under the current CAS nomenclature system. All 57 confidential substances are identified by "serial numbers" instead of CAS numbers.

By substance type, there are 449 organic substances, accounting for 93.2% of the total; 18 inorganic substances, 3.7%; and 15 polymers, 3.1%. The 15 polymers are concentrated in the fields of functional polymers and specialty materials, such as the sodium salt of the hydrolyzate of an acrylic ester-vinyl acetate copolymer, and the reaction product of dimethylaminopropyl methyl siloxane with cadmium zinc sulfide selenide. The 18 inorganic substances are mainly multi-component metal oxides, fluorides, and coordination compounds (e.g., potassium fluorozincate, sodium pentaborate, hydrochloric acid solution of (SP-4-1)-tetrachloropalladic(II) acid, and aluminum cobalt lithium nickel oxide), reflecting downstream applications in high-end electronic materials, catalysts, and battery precursors.

Special attention should be paid to the 290 substances whose "new use environmental management scope" is blank. After being included in the IECSC this time, they are regarded as existing chemical substances, and companies may freely use them for any industrial use. However, for substances whose new use environmental management scope is specified as "other industrial uses beyond permitted uses," a company need not conduct a new chemical substance registration only when its use is consistent with the permitted uses; otherwise, it must first obtain a registration certificate for the intended use before it may commence production or import. Most notably, 63 substances have a new use environmental management scope of "all industrial uses," meaning that any company producing or importing such a substance for any industrial use must first conduct a new chemical substance registration and obtain a registration certificate. For substances with a scope of "all industrial uses," it is expected that, before supplementing them into the Inventory, the competent authority re-evaluates the submitted registration materials and hazard data and determines that the corresponding substances fall under the "high-hazard category." Under Order No. 12, for high-hazard chemical substances included in the Inventory, when a registration certificate holder changes the use, or when any person other than the holder uses the substance for industrial purposes, an application for new use environmental management registration must be filed before production, import, or processing use.

Compliance Impact

Figure: Distribution of Key Compliance Characteristics of the 482 Substances

As shown in the figure above, all 482 chemicals have successfully transitioned from "regular registration obtained" to "IECSC-listed". Among them, roughly a quarter lack CAS numbers, nearly 40% are bound by new use management rules, and about 12% are confidential.

For manufacturers, importers, and downstream users, the IECSC supplementation this time has two major practical implications:

(1) The window for switching a substance's "new/existing" status has closed: From the date of issuance of this announcement, the substances it covers have switched from "new chemical substances" to "existing chemical substances in China." Relevant companies no longer need to invest in "new chemical substance registration." However, for those subject to new use restrictions, companies must still confirm the boundaries of their use and register new uses as required; otherwise, they may still violate the new chemical substance environmental management regulations.

(2) For confidential substances, proactive confirmation is still required: Confidentiality in the IECSC only means that the way a substance's identity is disclosed is restricted (presented as a generic name/serial number); the competent authority still holds its complete identification information. Companies that cannot confirm whether their chemical substance has been included in the Inventory should proactively entrust a query with the competent authority to confirm whether their substance constitutes a new chemical substance.

Practical Compliance Advice for Industry

In light of this batch of IECSC supplementation, the current regulatory requirements under MEE Order No. 12, and the ongoing revision of the Measures, companies are advised to focus on the following two points:

1. Immediately compare material lists. Cross-reference internal raw material and product lists against the 482 newly listed substances. Pay special attention to the 192 restricted/high-hazard substances to establish a internal Use Compliance Ledger, ensuring Procurement, EHS, and Legal teams confirm operations stay strictly within authorized uses.

2. Distinguish between "Listed on IECSC" and "new use management": Being listed on the IECSC does not mean unconditional market access. Any chemical subject to new use rules that is applied outside its permitted scope continues to be regulated with the stringency of a new chemical substance.

Outlook: Strict Penalties Under China's Ecological Environment Code

With China’s upcoming Ecological Environment Code raising the compliance baseline, non-compliance penalties are scaling significantly. Producing, importing, or processing registered substances outside authorized scopes—or operating without a valid certificate—can now incur fines up to 2 million RMB (~$280,000 USD).

Repeated or severe violations carry escalating administrative risks, including mandatory production restrictions, operational suspension, or full business license revocation.

As China continues refining MEE Order No. 12, regulatory expectations will only tighten. Companies managing complex chemical portfolios in China are advised to monitor official guidance closely.

Why Choose CIRS

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

Our Services

• China new chemical substance registration;
• Only Representative (OR);
• IECSC Enquiry and Inventory Adding;
• Chemical Safety Report (CSR) Compilation;
• Testing Coordination/Supervision;
• Alternative methods (QSAR, Read-Across, In-vitro, Waiver, Evaluation);
• Post-registration (Annual Report, Certificate Renew)
• China REACH Training Service;

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further information

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