Regulatory Developments

China Publishes Draft Law on Safety of Hazardous Chemicals

October 16, 2020 PRINT

The Chinese Ministry of Emergency Management (MEM) released the “Law on Safety of Hazardous Chemicals (Draft for Consultation)” (LSHC) on October 2, 2020, to replace the “Regulations on Safe Management of Hazardous Chemicals” (Decree No. 591). The deadline to submit comments to MEM regarding the LSHC is November 1, 2020. Comments can be submitted to MEM via e-mail (yjbzfs@163.com).

What Is New?

The draft LSHC was first introduced in 2017. This draft revision will replace the current Decree No. 591, introducing hazardous chemical registration exemptions for research and development (R&D), test marketing, low volume, low release and low exposure, and polymers.

Compared to Decree No. 591, the draft LSHC also expands the scope and authorizes relevant ministries to regulate the entire supply chain of hazardous chemicals, including project and establishment planning and development, production, storage, use, distribution, transport, and disposal. It defines hazardous chemicals as chemical substances that possess toxic, corrosive, explosive, flammable, or combustible properties and highly toxic chemicals that are harmful to humans, facilities, and the environment. Hazardous chemical management will be catalogue based. The Catalogue of Hazardous Chemicals and the principles for determining hazardous chemicals will be issued, updated, and maintained by the relevant ministries according to the standards on hazardous characteristics and classification and the actual safety management needs.

The LSHC authorizes MEM to manage hazardous chemical registration. MEM will issue implementation measures for hazardous chemical registration, including exemptions for R&D, test marketing, low volume, low release and low exposure, and polymers. Hazardous chemical registration must include classification and labeling, physicochemical properties, main uses, hazardous characteristics, safety requirements for storage, uses, transportation, and disposal, and emergency response plans.

The LSHC authorizes the Ministry of Ecology and Environment (MEE) to regulate disposal of hazardous chemicals and requires institutes that generate hazardous chemical waste to have a hazardous chemicals waste management plan, log records, and report the records to the local authority through the National Information Management System for Hazardous Wastes.

The LSHC requires manufacturers of hazardous chemicals and operators of warehouses storing hazardous chemicals to designate qualified personnel as full-time safety management staff and to provide safety data sheets (SDS) to employees in the workplace. Enterprises producing, storing, and using hazardous chemicals shall be equipped with automatic monitoring and control systems according to national or industry standards.

The LSHC combines business licenses for production, operation, and use of hazardous chemicals into one license. Manufacturers that produce hazardous chemicals with low risk and simple processes and without chemical reactions may submit a record filing to a local authority. All other enterprises that produce, distribute, or use hazardous chemicals must obtain the business license.

The LSHC prohibits online sales of highly toxic and explosive chemicals. In addition, the LSHC increases the penalties for violations significantly, including fines ranging from five to ten times the value of the goods and penalties for both the enterprise and responsible executive officers.

Commentary

The draft LSHC proposes several changes that will be less burdensome for industry while allowing MEM to focus on the regulation of hazardous chemicals that pose the greatest potential risks to human health and the environment. Manufacturers in China that produce low-risk hazardous chemicals using simple processes that do not involve chemical reactions will not be required to obtain business licenses, but will be eligible for a record filing with a local authority once the LSHC becomes effective. The draft law also introduces hazardous chemical registration exemptions for R&D, test marketing, low volume, low release and low exposure, and polymers, addressing a major shortcoming in the current Decree No. 591.

The implementation rules and guidance documents are expected after the draft law is released in final. The schedule for release of this law in final, however, was not provided.

For further assistance, please e-mail or call J. Brian Xu, M.D., Ph.D., DABT® at bxu@actagroup.com or (202) 266-5029.


 
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