China New Chemical Substance New Usage Management Registration

Overview of New Usage Management under MEE Order No. 12

The regulatory landscape for chemical substances in China is primarily governed by the Measures for the Environmental Management Registration of New Chemical Substances, commonly referred to as MEE Order No. 12. Effective since January 1, 2021, this regulation replaced the previous MEE Order No. 7, establishing a modern framework for the environmental management of both new and existing chemical substances.

New Usage Management Registration is a specific regulatory pathway designed for chemical substances already listed in the Inventory of Existing Chemical Substances in China (IECSC). When a substance is listed with specified restricted uses, any manufacturer, importer, or processing user intending to apply the substance for other industrial purposes—beyond those already specified—must fulfill registration obligations. This regime ensures that the environmental and health risks associated with changing or expanding chemical applications are thoroughly evaluated before market activities begin.

Applicable Conditions and Registration Bodies

New Usage Management Registration applies under specific legal triggers. It is mandatory when a chemical substance listed in the IECSC with specified restricted uses is intended to be used for other industrial purposes, regardless of the volume.

Who Must Register?

The obligation to register falls upon several key stakeholders within the supply chain:

• For highly hazardous chemical substances: The registration certificate holder who intends to change the use of the substance, as well as manufacturers, importers, or processing users who plan to use the substance for industrial purposes other than those specified.
• For substances with persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB) properties: Any manufacturer, importer, or processing user intending to use the substance for industrial purposes other than those specified in the inventory must register.

Failure to comply with these registration mandates can result in severe penalties and the potential removal of the product from the Chinese market.

Required Materials and Documentation

The registration process requires the submission of a comprehensive dossier to the Solid Waste and Chemicals Management Center of the MEE (SCC-MEE). The documentation must provide a clear assessment of the risks associated with the new use.

Core Application Materials

• Formal registration application form.
• Legal person certificates, business licenses, or representation contracts.
• Detailed testing reports or data regarding the substance's properties including GLP compliance status where applicable.
• Environmental exposure assessment reports and proposed environmental risk control measures.
• Information on socio-economic benefit analysis (specifically for highly hazardous new chemicals).
• Technical qualifications of the testing institutes involved in data generation.

The dossier must demonstrate that the proposed new usage can be managed safely without posing uncalculated risks to the environment or public health.

Registration Process and Timeline

The process for New Usage Management Registration involves several critical phases, from data gap analysis to official technical review by the experts of SCC-MEE.

Process Workflow

The procedure begins with a thorough analysis of the substance and its intended new use. If existing data is insufficient, testing must be conducted to fill data gaps. Once the dossier is prepared, it is submitted for a two-stage review process: a formal completeness check followed by a rigorous technical review. If the application meets all safety and regulatory criteria, an updated registration certificate is issued, and the new use is officially added to the IECSC.

Estimated Timeline

According to current regulatory practices, the registration period of record registration is 5 to 8 months. This timeframe accounts for the necessary technical evaluations and administrative procedures required to ensure the environmental safety of the proposed new usage.

Proregulations' China Chemical Registration Services

Our team provides comprehensive, one-stop compliance solutions for enterprises operating within the Chinese chemical market. We leverage extensive regulatory experience to streamline the registration process.

• Representative agent service
  We provide professional representation for foreign enterprises, acting as the local agent to handle all administrative and technical communications with Chinese authorities.
• New usage management identification
  Our experts analyze your product's status within the IECSC to determine whether your specific application triggers New Usage Management Registration requirements.
• Dossier preparation and risk assessment
  We assist in the preparation of environmental exposure assessment reports and all technical documentation required for SCC-MEE submission.
• Communication with competent authorities
  We facilitate direct and effective communication with regulatory experts and government officials to resolve technical queries and expedite the review process.

If you need to navigate the complexities of China's new chemical substance regulations and ensure your products meet all legal requirements for new usage, please contact us.