China Chemical New Usage Environmental Management Registration: REACH24H’s Guide & Tips
Introduction
On April 25, 2025, the Ministry of Ecology and Environment (MEE) released the approval results for the first batch of New Usage Environmental Management Registration in 2025. Shortly after, on May 6, 2025, the MEE updated the list of permitted usages for chemical substances in the Inventory of Existing Chemical Substances in China (IECSC). These developments mark a significant milestone under the Measures for the Environmental Management Registration of New Chemical Substances (Order No. 12). REACH24H Consulting Group successfully assisted ENEOS Corporation in navigating this process, gaining valuable insights into the registration framework. This article provides a comprehensive analysis of the New Usage Environmental Management Registration process, its regulatory framework, and practical compliance strategies.
What Is New Usage Environmental Management Registration?
The Registration System for Environmental Management of New Usage is a critical regulatory framework in China designed to oversee chemical substances already listed in the Inventory of Existing Chemical Substances. This system applies when these substances are intended for industrial usages beyond their originally permitted purposes, ensuring compliance with environmental safety standards.
Under this system, applicants—including producers, importers, processors, and users of the relevant chemical substances—must submit registration applications to the Ministry of Ecology and Environment (MEE). These applications are evaluated under the environmental management regulations for New Chemical Substances, ensuring proper oversight and risk assessment.
The primary goal of this regulatory system is to evaluate and control the risks that the new usages of these chemical substances may pose to the ecological environment and human health. This framework aligns with China’s guiding principles of “source-based access, risk prevention, and categorized management,” emphasizing sustainable and responsible chemical management practices
Key Regulations:
Measures for the Environmental Management Registration of New Chemical Substances (Order No. 12).
Guidelines for the Environmental Management Registration of New Chemical Substances.
Step-by-Step Registration Process and Key Considerations
Which Substances Require Registration?
Chemical substances listed in the IECSC and subject to New Usage Environmental Management must undergo registration for industrial usage beyond their approved scope. Two scenarios apply:
Substances with PB, PT or BT properties: Registration is required for expanded usages, and approved new usages are added to the IECSC.
Highly Hazardous Chemical Substances: Usages that are not listed in the IECSC, as well as those listed in the IECSC but without a Regular Registration Certificate, must undergo New Usage Environmental Management Registration. Registration is mandatory for new usage, but these usages are not added to the IECSC.
How is a New Usage Defined?
A new usage is determined by changes in exposure pathways. Examples include:
- Change in industry: When the new usage and the original usage belong to entirely different industries, adjustments are made to the environmental management scope in the IECSC. For instance, if the original usage is as a pharmaceutical intermediate and the new usage is as a coating additive, the change is managed by combining the new usage with the original usage. This ensures that both applications are effectively covered under the revised scope.
- Partial overlap: In cases where the new usage partially overlaps with the original usage but does not entirely include it, the environmental management scope is adjusted accordingly. For example, if the original usage is an automotive engine oil lubricant additive and the new usage is a gas engine oil lubricant additive, the revised scope will combine both usages.
- Scope expansion: When the new usage fully encompasses and broadens the scope of the original usage, the environmental management scope is updated to reflect only the new usage. For example, if the original usage is a gasoline additive and the new usage is a fuel additive, the revised scope will focus solely on the new usage. This streamlines management and avoids unnecessary overlap.
The above outlines the three primary types of Change of Usages, which are classified under Environmental Management Registration related to New Usage.
Is There a Volume Threshold for Registration?
No. Unlike new chemical substances, existing substances requiring New Usage Environmental Management Registration have no volume threshold. Even if the annual volume is less than 1 ton, registration is mandatory.
Importantly, there is no minimum tonnage threshold for New Usage Environmental Management Registration. Even if the annual tonnage of the new usage is less than 1 ton, it is still mandatory to submit the necessary documentation to comply with the New Usage Environmental Management Registration requirements.
What Documents Are Required?
Applicants must submit:
- Application form for New Usage Environmental Management Registration.
- Environmental Exposure Assessment Report and Risk Control Measures.
- Hazard property test reports (if applicable).
- Socioeconomic Benefit Analysis Report (for highly hazardous substances).
How Long Does Approval Take?
The timeline aligns with standard registration processes. The registration process is shown in the following figure:
The Technical Review process is conducted by the Expert Committee, which is organized by the State Council’s Competent Department of Ecology and Environment, in collaboration with the affiliated Technical Institution for Chemical Substance Environmental Management. During the review, if the application materials are deemed insufficient for a comprehensive environmental risk assessment of the substance in question, the applicant is required to provide additional test reports or relevant documentation as specified in the Supplementary Notice. These materials must be submitted for a new Environmental Risk Assessment. Once the State Council’s Competent Department of Ecology and Environment reaches a decision regarding the New Usage Environmental Management Registration, the outcome is publicly disclosed on its official website.
For chemical substances not classified as Highly Hazardous Chemical Substances, the approved Permitted New Usage is added to the IECSC. However, for substances classified as Highly Hazardous Chemical Substances, the scope of New Usage Environmental Management in the IECSC remains unchanged.
It is important to note that no physical Registration Certificate is issued for New Usage Environmental Management Registration. Instead, the public disclosure of the approval result on the official website serves as the formal record. Additionally, for Non-Highly Hazardous Chemical Substances, updates are made to the Permitted Use List in the Inventory of Existing Chemical Substances in China to reflect the approved changes.
What Are Post-Registration Obligations?
New Usage Environmental Management Registration, once approved, must adhere to the post-registration follow-up management requirements for Conventional Registration. Below are the key requirements for compliance:
- Information Transmission: Ensuring Proper Communication
Entities are required to transmit risk control measures for the new usage in either electronic or written formats. This information must pass through successive levels to reach the end processor or user. Additionally, the transmitted content and corresponding evidence of transmission must be properly archived for future reference and record-keeping.
- Information Disclosure: Promoting Transparency
Environmental risk control measures, along with the implementation status of environmental management requirements, must be disclosed publicly. This can be achieved through the official website or other accessible methods. All disclosure methods and content must be documented and retained to ensure compliance and transparency.
- Reporting New Hazard Information and Environmental Risk Monitoring
In the event that new environmental or health hazard characteristics or risks are identified, entities must report these findings immediately to MEE. If there is a potential increase in environmental risk, prompt measures must be taken to mitigate or eliminate the risks effectively.
- Data Retention: Maintaining Comprehensive Records
Entities must retain all relevant documentation, including activity records, for a minimum period of ten years. This ensures that historical data is available for reference and compliance verification.
- Compliance with Environmental Supervision and Management
Entities are obligated to comply with and cooperate during random supervisory inspections conducted by the competent authority for ecology and environment. These inspections are aimed at ensuring adherence to the environmental management requirements for newly registered chemical substances.
By following these requirements, entities can ensure compliance with the regulatory framework for New Usage Environmental Management Registration while minimizing environmental risks.
Challenges and Solutions in Environmental Risk Assessment
Environmental Exposure Assessment Reports and Environmental Risk Control Measures are essential documents required for submission. They play a critical role in the technical review process for Environmental Management Registration for New Usages, ensuring compliance and safety.
The methodology for preparing Environmental Exposure Assessment Reports and Environmental Risk Control Measures in the context of new usages largely aligns with the approach used for Environmental Risk Assessment Reports in conventional registrations. Despite these similarities, there are distinct challenges that are unique to the Environmental Management Registration for New Usage.
Below, we outline the specific challenges associated with Environmental Management Registration for New Usages:
| Challenge | Scenario | Solution |
| Data insufficiency | To effectively assess the environmental and health risks associated with a substance under application, it is essential to gather relevant hazard data. However, applicants may sometimes lack the necessary test data. In such cases, the evaluation of key health toxicology and ecotoxicology effects can be conducted based on the chemical structure of the substance. | Use QSAR, Read-cross, referencing, or conduct testing to fill data gaps.
This can be achieved using methods like QSAR (Quantitative Structure-Activity Relationship), Read-across, or References with existing data. If these approaches prove insufficient, partial testing of the substance may be required to fill the data gaps. |
| Differentiating Usages | A critical aspect of risk characterization is the clear specification of differences in exposure scenarios between the new usage and the original usage of the substance. | This should be addressed in a dedicated section that comprehensively outlines these differences. Key areas to cover include: Industrial Source, Consumer Usage Sources, and Solid Waste Management.
By detailing these exposure scenarios, a more accurate risk assessment can be achieved, ensuring that both environmental and health risks are effectively managed. |
Compliance Tips for Enterprises
Enterprises must carefully address the following critical aspects when applying for New Usage Environmental Management Registration:
- Advance Planning for Compliance: Begin with a thorough Regulatory Compliance Assessment for projects involving new usages. This step helps determine whether New Usag Environmental Management Registration is necessary and ensures a smooth application process.
- Conducting a Scientific Environmental Exposure Assessment: Prioritize the scientific accuracy and comprehensiveness of the Environmental Exposure Assessment. Pay particular attention to identifying and mitigating specific environmental risks associated with the proposed new usages.
- Addressing High-Hazard Substances with Care: If the application involves high-hazard chemicals, provide a well-documented justification for their necessity. Additionally, prepare a detailed Socioeconomic Benefit Analysis to support the application.
- Ensuring Ongoing Compliance Post-Registration: Once the New Usage Registration is obtained, strictly implement all Environmental Risk Control Measures and adhere to Environmental Management Requirements to maintain compliance throughout operations.
- Staying Updated on Regulatory Changes: Actively monitor any updates or changes to Regulatory Policies. Adjust your Compliance Strategy promptly to align with the latest requirements and avoid potential risks.
By focusing on these key points, enterprises can enhance their chances of successful registration and maintain long-term compliance with environmental regulations.
Final Thoughts
New Usage Environmental Management Registration is a cornerstone of China’s chemical substance management system, emphasizing stringent oversight for hazardous substances. Enterprises must approach the process with careful planning and ongoing compliance efforts.
REACH24H Consulting Group remains committed to providing practical guidance and updates on New Usage Environmental Management Registration. Stay informed with our latest insights and feel free to contact us!
