If your company plans to manufacture, import, sell, or use a chemical substance in China, the first compliance question is not only whether the substance is hazardous, but whether it is considered “new” under China REACH.
Under China’s Measures for the Environmental Management Registration of New Chemical Substances, commonly referred to as MEE Order No. 12 or China REACH, a chemical substance that is not listed in the Inventory of Existing Chemical Substances in China (IECSC) may require registration or notification before it can be manufactured or imported into China.
REACH24H helps overseas manufacturers, exporters, formulators, distributors, and importers identify their obligations under MEE Order No. 12, determine the right registration pathway, and complete China REACH compliance efficiently.
What is China REACH?
China REACH is the commonly used industry term for China’s regulatory system governing the environmental management of new chemical substances, formally established under the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12).
Effective from January 1, 2021, MEE Order No. 12 replaced the former MEP Order No. 7 and established the current unified regulatory framework for the registration and control of new chemical substances in China.
Under China REACH, a chemical substance is considered “new” if it is not listed in the Inventory of Existing Chemical Substances in China (IECSC). Companies intending to manufacture or import such substances must complete the required registration procedures before placing them on the Chinese market.
Failure to obtain the required registration prior to market entry may result in administrative penalties, business suspension, or other enforcement actions under China REACH.
What is IECSC(Inventory of Existing Chemical Substances in China)?
Maintained by the Ministry of Ecology and Environment (MEE), the Inventory of Existing Chemical Substances in China (IECSC) serves as the official regulatory register for chemicals legally recognized as "existing" within the country.
A substance may generally be considered “existing” if it is listed in the IECSC. A substance not listed in the IECSC may be considered a new chemical substance and may require registration or notification before manufacture or import.
The IECSC includes:
Existing chemical substances manufactured, processed, sold, used or imported in mainland China during the specified historical period;
New chemical substances that were previously registered under the regular registration pathway and have met the requirements for inclusion after the applicable period;
Certain substances with use restrictions or new usage environmental management requirements.
How to Check Whether a Substance is Listed in the IECSC?
Determining your substance's status on the IECSC is the critical first step in China REACH compliance.
Public substances: Companies can utilize free online databases, such as the Chemcheck search tool, to verify substances by CAS number or chemical name.
Confidential substances: Certain substances are protected and do not appear in public online searches. In these cases, a comprehensive formal IECSC inquiry through the Solid Waste and Chemicals Management Center (MEE-SCC) is highly recommended to confirm whether the substance is deemed "new" and to avoid unnecessary registration costs.
Need to confirm your substance status? REACH24H can support public and confidential IECSC screening before you commit to testing, shipment or registration.
Which Substances Require Registration Under MEE Order No. 12?
According to MEE Order No. 12, registration is mandatory for new chemical substances prior to manufacture or import. This requirement encompasses a wide range of categories.
Regulated Categories:
Industrial Applications: New chemical substances intended for use as pharmaceuticals, pesticides, veterinary drugs, cosmetics, food additives, feed additives, and fertilizers, specifically when these substances are repurposed for other industrial applications. This also includes raw materials and intermediates used in their production.
Functional Products: New chemical substances contained within surfactants, plasticizers, preservatives, dispersants, flame retardants, and similar functional preparations.
Polymers: All new polymers not listed in the IECSC.
Articles: New chemical substances contained in articles that are intended to be released during general use.
Intermediates: All intermediates that do not qualify as non-isolated intermediates.
New Usage Environmental Management:
Registration is also required for chemical substances already listed in the IECSC if they are subject to "new usage environmental management" and are intended for industrial applications other than their permitted uses. This specifically targets:
Highly hazardous chemical substances;
Chemical substances with persistence and bioaccumulation (PB), or persistence and toxicity (PT), or bioaccumulation and toxicity (BT) properties.
Exemptions from China REACH Registration
Certain products or substances may fall outside the scope of China REACH, including:
Pharmaceuticals (including active pharmaceutical ingredients), pesticides (including pesticide technical), veterinary drugs(including active pharmaceutical ingredients), cosmetics, food, food additives, feed, feed additives, fertilizers, and other products;
Radioactive Substance;
Naturally occurring substances;
Non-commercial or non-intentionally produced substances: impurities, by-products, wastes, etc;
Other special categories: alloy, non-isolated intermediates, articles, the mixture of existing chemicals that are artificially blended and without producing new chemicals, an anhydrous chemical and its hydrate, one of which has been listed in the IECSC, etc.
Who Must Apply for China REACH Registration?
Compliance with China REACH applies to entities involved in the supply chain of new chemical substances entering China.
Domestic manufacturers of new chemical substances in China;
Direct importers of new chemical substances in China;
Overseas manufacturers or exporters supplying new chemical substances to China;
Manufacturers, importers, processors, or users changing exempted products to other industrial uses;
Parties using IECSC-listed substances subject to new usage environmental management outside the permitted use scope.
Overseas companies may apply, but they should designate a qualified representative agent in mainland China to support registration and post-registration obligations.
Companies from Hong Kong, Macao, and Taiwan should also appoint a mainland China representative agent when applying for registration.
China REACH Registration Types
Under MEE Order No. 12, new chemical substances are registered under three types: record notification, regular registration, simplified registration, and new usage management registration.
Registration Types | Scope |
|---|---|
Record Notification | 1) New chemical substances manufactured or imported with an annual volume of less than 1 ton; 2) Polymers containing less than 2% monomers or reactants which are new chemical substances, or polymers of low concern (no volume limit), including：
New chemical substances not conforming to the record registration conditions for polymers or meeting the exclusion requirements for polymers shall be subject to regular or simplified registration. |
Simplified Registration | 1 t/a ≤ Annual Manufacturing / Importation Volume < 10 t/a |
Regular Registration | Annual Manufacture / Importation Volume ≥ 10 t/a; |
New Usage Management Registration | Chemical substances subject to new usage environmental management in the IECSC. |
Timelines for Different Registration Types under MEE Order No. 12
Registration Types | Registration Period |
|---|---|
Record Registration | 1～2 Weeks |
Simplified Registration | 8～12 Months |
Regular Registration | 14～24 Months |
New Usage Management Registration | 6~12 Months |
These timelines reflect the typical duration from testing, dossier preparation to competent authority approval under China’s Regulation on the Environmental Management of New Chemical Substances (MEE Order No. 12).
China's New Chemical Substance Registration Process
A typical China REACH registration project includes the following steps:
Substance Identification and IECSC Check: Determine if the substance is exempt or listed on the IECSC. If not listed, confirm the required Registration Type based on volume and use.
Registration Pathway Determination: Select the appropriate pathway based on annual volume, substance type, polymer status, intended use, and hazard profile.
Data Gap Analysis: Assess existing data against MEE Order No. 12 requirements, including Persistence, Bioaccumulation, and Toxicity (PBT) property determination.
Testing and Data Generation: Conduct necessary physicochemical, toxicological, and ecotoxicological testing at certified laboratories to fill identified data gaps.
Dossier Preparation: Compile the registration dossier, including Risk Assessment Reports and Socio-Economic Benefit Analysis Reports where applicable.
Submission and Review: Submit the dossier via the online registration system. The MEE will conduct a formal technical review.
Certificate Issuance: Upon successful review, the MEE issues the Registration Certificate or publishes the Record Receipt.
Understanding Registration Costs
The total cost for China REACH consists of three major parts, namely the administration fee, the testing fee, and the consulting fee.
Administrative Fees: Under the MEE Order No. 12, the Ministry of Ecology and Environment (MEE) does not charge an official administrative fee for the review, evaluation, or issuance of a Registration Certificate. However, a comprehensive inquiry service provided by the regulatory technical support body (currently the Solid Waste and Chemicals Management Center, MEE-SCC) to definitively confirm the substance’s status on the IECSC and its regulatory requirements typically costs 3,000 RMB per substance.
Consulting Fees: The consulting fee will be charged by the OR-like representative agent mainly for the preparation of dossiers and the fulfillment of post-notification obligations, e.g., preparation of risk assessment report and annual report, etc.
Testing Fees: The notifying companies still need to take into account their own capital investment on notification dossier preparation, especially the testing data production. The testing fee accounts for a large proportion of the total costs, compared with the administrative fee and consulting fee. The higher the tonnage band, the more testing data is required. However, some testing items can be exempted through data gap analysis.
How REACH24H Can Support Your China REACH Compliance?
REACH24H provides professional support for China New Chemical Substance Registration under MEE Order No. 12, covering all four pathways: record notification, simplified registration, regular registration, and new usage environmental management registration. Our services include:
Regulatory Strategy Assessment
Determine whether your substance triggers China's new chemical substance registration under MEE Order No. 12 and identify possible exemptions based on substance status, intended use, annual volume, and supply chain role.
IECSC Search and Inventory Assessment
Support public and confidential IECSC searches, interpret inventory results, and assess whether the inventory listing may be applicable before companies commit to testing, shipment, or registration.
Full Registration Support
Provide one-stop support for record notification, simplified registration, regular registration, and new usage environmental management registration, covering the full process from pathway selection to authority submission.
Dossier and Risk Assessment
Prepare and review registration materials, including substance identity, hazard assessment, environmental risk assessment, exposure scenarios, and risk control measures required under MEE Order No. 12.
Data and Testing Strategy
Provide data gap analysis, testing strategy, PBT assessment, QSAR/read-across support, data waiver evaluation, and GLP laboratory coordination to reduce unnecessary testing time and cost.
Post-registration Compliance
Support activity records, first activity reports, annual reports, information disclosure, certificate amendment, re-registration, supply chain communication, and internal compliance training.
Why Choose REACH24H?
Full Coverage of All Registration Types
REACH24H has practical experience in all four China REACH pathways: record notification, simplified registration, regular registration, and new usage environmental management registration.
Proven Project Experience
As of 2026, REACH24H has supported hundreds of companies in completing over 4,000 notification and registration projects, including complex and high-volume cases.
Expertise in Difficult Substances
We have experience with challenging substances such as UVCBs, poorly soluble substances, highly volatile substances, and unstable substances, supporting testing design, data waiver strategy, and environmental risk assessment.
Multilingual Technical Team
Our team combines expertise in chemistry, chemical engineering, biology, pharmacology, toxicology, and environmental science, with service capabilities in English, Chinese, Japanese, Korean, and German.
One-stop Compliance Support
From IECSC screening and registration strategy to dossier submission, authority communication, post-registration reporting, and internal training, REACH24H supports the full lifecycle of China's new chemical substance compliance.
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