China New Chemical Regular Registration

Former Filing Cases: Effective August 15, 2026, low-volume substances and qualifying polymers that previously met filing criteria must follow the current transitional registration requirements. Applications are accepted, reviewed, and approved by reference to simplified registration procedures and timelines. The regular and simplified registration information below must be read in light of the conditions applicable to each substance. Learn about the 2026 requirements for cases previously eligible for filing.

Under MEE Order No. 12 (often referred to as China REACH), new chemical substances with an annual manufacture or import volume of 10 metric tons or more are subject to regular registration, except where a former filing condition or another applicable regulatory provision applies. For annual volumes of 1 metric ton or more but less than 10 metric tons, review the simplified registration requirements, subject to the applicable substance-specific conditions.

How to determine whether registration is required? To prepare and apply for registration for environmental management of new chemical substances, determine whether registration is needed from the following aspects: 1. The substance to be applied for is a new chemical substance and meets the scope requirements for registration; 2. The region of the activity for the substance to be applied for falls within the scope specified in the Measures; 3. The applicant and its agent meet the requirements of the Measures and this guide. Applicants for environmental management registration of new chemical substances can query the Inventory publicly released by the competent department of ecology and environment under the State Council to confirm whether the relevant chemical substance is included in the Inventory. For substances marked with class names in the Inventory, applicants for environmental management registration of new chemical substances shall provide accurate identification information such as the Chinese and English names, CAS number, molecular formula, and structural formula of the new chemical substance intended for production, import, or processing and use, as well as information related to the activity type such as research, production, processing and use methods, or import plans, and submit it to the competent department of ecology and environment under the State Council for confirmation whether the substance is included in the Inventory.

Registration Procedure

• Determine whether registration is required To apply for environmental management registration of new chemical substances, determine whether the substance meets the registration requirements, confirm whether the substance is included in the Inventory, and provide relevant information.
• Prepare for registration Select the type of environmental management registration for new chemical substances and prepare the registration application materials as required.
• Submit application materials Applicants can submit materials through the online registration system. When entrusting a third party to submit on their behalf, a power of attorney must be provided, and the applicant is responsible for the authenticity of the materials.

Application Material Requirements

The application materials for regular and simplified registration of new chemical substances submitted by the applicant shall meet the following requirements:

Our Services

Regulix® provides registration services for new chemical substances exported to China.

• Help companies understand regulatory requirements for new chemical registration.
• Act as agent for new chemical registration, handling preparation and submission.
• Advise on environmental and safety measures to ensure regulatory compliance.