China New Chemical Simplified Registration

Professional compliance, efficient registration

"The cooperation was very pleasant. The team is highly professional and meticulous in handling new chemical substance registration. Whether it's policy interpretation or document preparation, they provided full support. The service is efficient and targeted, truly trustworthy!"

Frank - R&D Center Director, Pharmaceutical Company

Osaka

"The company's service is very thorough. The new chemical substance registration process went smoothly, with detailed guidance provided for both consultation and actual operations. Their professional capabilities and service attitude left us very satisfied. We will continue to cooperate in the future!"

Annie - Specialist, Specialty Chemicals Company

London

"Cooperation with Regulix went very smoothly. The professional team provided comprehensive support for new chemical substance registration. The entire process was efficient and transparent, with quick responses and answers to all our questions, greatly saving us time and effort."

Sophia - Manager, Chemical Company

Los Angeles

Simplified Environmental Management Registration for New Chemical Substances

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 1 metric ton or more but less than 10 metric tons are subject to simplified registration, except where the substance falls within a previously applicable filing condition or another applicable regulatory provision. For annual volumes of 10 metric tons or more, review the regular registration requirements, subject to the applicable substance-specific conditions. The application materials for simplified registration should include the following: (1) New chemical substance simplified registration application form; (2) Test reports or data, arranged in the order they appear in the application form; (3) Determination conclusions and basis for the persistence, bioaccumulation, and toxicity of the applied substance in accordance with the requirements of this guide; (4) Materials explaining the necessity of information protection; (5) Commitment to implement or pass on environmental risk control measures; (6) Information on the qualifications of the testing institution;

Industrial chemical powder sample - Preparation for China REACH Simplified Registration

Registration Exemption Categories

Naturally occurring substancesNatural substances that have not undergone chemical treatment or have only been processed by physical methods, extracted from air, and biological macromolecules such as nucleic acids and proteins
Non-commercial or unintentionally produced categoriesImpurities that do not contribute to product function, as well as products generated from reactions with substances or environmental factors, including by-products from storage, use, reactions, wastewater, waste gas, solid waste, etc.
Alloy categories Homogeneous or heterogeneous solids or liquids formed by mixing two or more metals or one metal with other non-metals

Activity Types for Environmental Management Registration of New Chemical Substances

Activity types for environmental management registration of new chemical substances include research, production, import, and processing and use of new chemical substances

Research

Exploring new chemicals via scientific and product development research

Production

Producing new chemicals via chemical reactions using raw materials or ingredients

Import

Importing new chemicals for domestic use, production, or lawful activities

Processing and Use

Using new chemicals in packaging, formulation, or synthesis processes

Regulix consultants discussing MEE Order 12 Simplified Registration requirements

Our Services

Regulix® provides agency services for environmental registration of new chemical substances exported to China

Offer consulting to help enterprises understand environmental registration requirements for new chemical substances
Act as agent for enterprises in registration, handling preparation, submission, and follow-up to ensure smooth process
Provide advice on environmental impact and safety measures to ensure compliance with related regulations

Tailored Expert Care
Seamless Process Aid
Regulatory Support

We tailor new chemical substance environmental management registration plans based on the specific circumstances of each enterprise, from application materials to subsequent reviews, ensuring precision and efficiency while avoiding cumbersome steps and unnecessary delays. This effectively reduces enterprise time costs and improves registration success rates.

From consultation and application to registration results, we provide full-process services, track progress in real time, and proactively resolve potential issues. Our team communicates with regulatory authorities to ensure every step proceeds smoothly, so enterprises do not need to worry about any process details.

We not only handle registration agency work but also provide clients with detailed regulatory interpretation services, helping enterprises understand policy changes and industry trends to ensure new chemical substances comply with the latest environmental management requirements, providing legal assurance for long-term enterprise development.