As a significant step forward in environmental management and regulatory oversight of new chemical substances, China has implemented the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12, hereinafter referred to as the Measures) for almost two and a half years. Under the Measures, if companies plan to manufacture or import chemicals not listed in the Inventory of Existing Chemical Substances in China (IECSC), they shall comply with certain new chemical registration or notification obligations. The corresponding registration certificate or record notification receipt shall be obtained prior to the manufacture or import. However, for certain listed chemicals in the IECSC, they shall also be regulated as new chemicals and require registration for new use environmental management.
This article will navigate you through the requirements concerning the new use environmental management registration under the Measures.
New Use Environmental Management Registration
What are the target chemicals?
Chemicals that meet all the followings:
They are listed in the IECSC with specific requirements for new use environmental management.
They are to be used for industrial purposes other than permitted use(s) that are specified in the IECSC.
Under this condition, before starting relevant activities, relevant companies shall apply to the MEE for new use registration. Notably, there’s no lower limit requirement for the manufacture/import quantity of the chemicals subject to new use registration.
Note: The target chemicals in the IECSC are highly hazardous chemicals or chemicals with PB/PT/BT* properties. *PB: persistent and bioaccumulative PT: persistent and toxic BT: bioaccumulative and toxic |
What are the required materials?
When applying for new use registration, required materials include:
The application form of new use registration;
The environmental exposure assessment report;
The environmental risk control measures for the chemical when it is used for any new use.
For highly hazardous chemical substances, in addition to the abovementioned materials, the socio-economic benefit analysis report shall also be submitted.
How long does the registration process take?
The whole process for new use registration will take 5 to 8 months.
Will registration certificate be granted?
As for New Use Environmental Management Registration, no registration certificate will be issued if approved, according to the official responses. However, after making the approval decision, the MEE will disclose the corresponding information on the MEE website within 20 working days, including:
The name of the applicant and its representative (if any) whose application is approved.
The name or generic name of chemical substances involved.
New use(s) registered.
Relevant environmental risk control measures and environmental management requirements.
Will the approved new use be added to the IECSC?
Where the chemical substance is not a highly hazardous chemical substance, its registered and approved new use shall be added to the IECSC. Where it is a highly hazardous chemical substance, its specified use requirement for new use environmental management in the IECSC shall remain unchanged.
