China New Chemical Substance Registration Support Services
One-Stop Support for Registration and Filing of New Chemical Substances in China
Since January 1, 2021, the "Measures for the Environmental Management Registration of New Chemical Substances" (Order No. 12 of the Ministry of Ecology and Environment) has been in effect in China. As a result, prior to the manufacture or import of new chemical substances, domestic manufacturer or importers in China are required to complete registration or application procedures. Alternatively, the final overseas exporter may appoint a local agent in China, who can carry out the registration or application process in accordance with relevant regulations.
Sumika Chemical Analysis Service, Ltd. (SCAS) leverages its extensive experience in regulatory consulting and acting as a Local Agent (LA), collaborating with our local subsidiary, Sumika Analysis & Evaluation Service (Shanghai) Co., Ltd. (SAES), and trusted partners throughout China. We offer a comprehensive one-stop service covering novelty assessment, preparation and submission of application documents, acquisition of test data, and LA services. This integrated approach ensures full regulatory compliance, streamlines procedures, and minimizes risks.
If you need support navigating China’s chemical regulations, please contact us. Our expert staff will provide prompt and thorough assistance.
Regulatory Information
Regulation Name
Measures for the Environmental Management Registration of New Chemical Substances (Order No. 12 of the Ministry of Ecology and Environment)
Effective Date
January 1, 2021
Competent Authority
Ministry of Ecology and Environment (Application Window: Solid Waste and Chemicals Management Technology Center)
Previous Regulations
Measures for the Environmental Management of New Chemical Substances (Order No. 17 of the State Environmental Protection Administration, effective September 12, 2003)
Measures for the Environmental Management of New Chemical Substances (Order No. 7 of the Ministry of Environmental Protection, effective October 15, 2010)
Overview
Objective Substances
Chemical substances not listed in the Inventory of Existing Chemical Substances in China (IECSC)
Chemical substances listed in the IECSC that are subject to new-use environmental management requirements
Eligible Applicants
Legal entities in China planning to manufacture or import new chemical substances
Legal entities outside China planning to export new chemical substances into China (appointment of a Local Agent in China is mandatory)
Requirements for Registration Certificate
Prior to manufacture or import, applicants must obtain the "New Chemical Substance Environmental Management Registration Certificate" or complete the "New Chemical Substance Environmental Management application"
Role of Local Agent (LA)
The LA jointly fulfills registration and post-registration environmental management obligations with the applicant and assumes legal responsibility in accordance with the law. Selecting a qualified agent is essential for overseas companies to ensure compliance and a smooth application process.
Types of Applications (Articles 11–14 of the Measures)
| Type of Application | Quantity Limit / Application Requirements | Required Documents / Testing |
|---|---|---|
| Application (Record) | Annual manufacture/import volume < 1 ton | Application documents only |
| Application (Record) for Polymers | Polymers with <2% new monomers or low concern polymers | Molecular weight distribution, degradability/stability, etc. |
| Simplified Registration | Annual manufacture/import volume 1–10 tons | Physicochemical properties, ecotoxicity |
| General Registration | Annual manufacture/import volume ≥10 tons | Physicochemical properties, human health toxicity, ecotoxicity |
| New Use Registration | Use for industrial purposes other than permitted uses | Environmental exposure, risk assessment, etc. |
Key Points for Compliance with China’s New Chemical Substance Regulations
Importance of Regulatory Compliance
Strict regulatory compliance is required for entering the Chinese market with new chemical substances. Proper registration and application under these regulations are directly linked to business reliability and risk mitigation.
Utilizing LA Services
For overseas companies, selecting an experienced LA is critical for a successful application process in China. LA provides expert support from document preparation and submission to fulfillment of post-registration environmental management obligations.
Preliminary Assessment and Strategic Planning
Conducting novelty assessments early, arranging necessary testing with consideration for other countries/regions, and preparing required documentation in advance are key to smooth market entry.
Services Provided by Sumika Chemical Analysis Center
Pre-Application Services
- Novelty assessment of chemical substances
- Development of application strategies based on your available data (physicochemical properties, human health and ecotoxicity data, intended use, exposure information, GHS classification, etc.)
Application-Related Services
- Identifying data gaps and planning testing strategies
- Arranging, monitoring, and obtaining various test data
- Preparation and submission of application documents
- Responding to authority feedback and comments
Registration Agent Services
- Acting as your official LA through SAES or our partner consultants in China (includes document retention, annual activity records, site inspection, and fulfillment of post-registration legal obligations)
Other Consulting Services
- Preparation of Chinese SDS and labels
- Coordination and negotiation with Chinese authorities
- Provision of regulatory survey reports, and more
Company Information
Sumika Analysis & Evaluation Service (Shanghai) Co., Ltd. (SAES)
Room 201, No.163 Jiangchang Third Road, Jing'an District, Shanghai, China 200436
TEL: +86-21-5677-8181
FAX: +86-21-5677-0215
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Contact Information
Environment, Health & Safety Division, Chemicals Compliance Unit
TEL: +81-3-5689-1216
Business hours: 9:00–12:00 and 13:00–17:30 (excluding weekends, national holidays, year-end/New Year holidays, and company holidays)
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