Regulations on Safe Management of Hazardous Chemicals (known as "China Decree 591") was published by the State Council of China on 11 March 2011 and entered into force on 1 Dec 2011. Decree 591 is the highest chemical control law in China and it regulates hazardous chemicals through the entire supply chain, from manufacture, importation, distribution, storage to transportation and use.
Decree 591 is not a single law. It is supported by dozens of ministerial regulations (including MEP order 7) and numerous guidance documents. Three main ministries involved are the Ministry of Environmental Protection (MEP), the State Administration of Work Safety (SAWS) and the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ).
Decree 591 require businesses who handle hazardous chemicals in China to apply for licenses to operate (“license system”) and submit HazChem registrations separately to two ministries (“HazChem registration”). Decree 591 also implements GHS in China requiring companies to provide SDSs and labels prepared in accordance with relevant national standards.
The picture below shows the main requirements of Decree 591 and relevant supporting ministerial regulations and standards.
Definition of Hazardous Chemicals and Catalogue of Hazardous Chemicals
In Decree 591, hazardous chemicals are defined as highly toxic chemicals and other chemicals which are toxic, corrosive, explosive, flammable and do harm to human body, facilities and environment. All chemicals meeting GHS hazard classification criteria may fall within its scope.
Among all hazardous chemicals placed on Chinese market, around 3000 chemicals have been added to the Catalogue of Hazardous Chemicals. This Catalogue is an administrative license Catalogue which means that businesses who handle hazardous chemicals in the Catalogue are subject to license requirements. In addition to that, hazardous chemicals in the Catalogue are subject to additional registration requirements under MEP order 22.
License System under Decree 591
Any legal entity producing, importing, distributing or using hazardous chemicals in the Catalogue of Hazardous Chemicals in China shall obtain a license from local Administration of Work Safety. There are three main types of licenses:
- Production license for producers;
- Operation license for importers, distributors, sellers, etc;
- Safe use license for certain downstream users(*)
*Safe use license is only required if the volume of certain hazardous chemicals used exceeds certain amount and the industry sector of the user is on the list of applicable industry sectors.
Detailed info about application of licenses can be found in the following supporting regulations issued by SAWS (in Chinese).
HazChem Registrations with SAWS
The article 66 and 67 of Decree 591 require domestic manufacturers and importers of hazardous chemicals to register hazardous chemicals with the National Registration Center of Chemicals (NRCC) of SAWS prior to manufacturing or importation. Detailed registration requirements and procedure are outlined in SAWS's order 53 - The Measures for the Administration of Registration of Hazardous Chemicals.
HazChem Registrations with MEP
Hazardous chemicals listed in the Catalogue of Hazardous Chemicals are subject to additional registration requirements under MEP Order 22 - The Measures for Environmental Administration Registration of Hazardous Chemicals.
Under MEP’s order 22, manufacturers and companies who use hazardous chemicals to manufacture products (“user”) in China shall register hazardous chemicals listed in the Catalogue with local environmental protection authorities and obtain environmental administration registration certificates.
For Priority Hazardous Chemicals for Environmental Management (PHCs), companies shall entrust qualified institutions to prepare an environmental risk assessment report and submit this report to authorities when applying for a registration certificate (article 10). PHCs are also subject to Pollutant Release and Transfer Register (PRTR) reporting every year.
In addition, MEP’s order 22 requires that companies who intend to export or import toxic chemicals on the “List of toxic chemicals severely restricted to be imported into or exported from China” apply for registration certificates or custom clearance notification from Solid Waste and Chemical Management Center (MEP-SCC).
Decree 591 and GHS Implementation in China
Decree 591 is the most important law implementing GHS in China. Article 15 requires chemical manufacturers to provide SDSs and labels prepared in accordance with relevant national standards. Article 37 prohibits distributors from selling hazardous chemicals without SDSs or labels. Companies who fail to classify, label and package hazardous chemicals in accordance with those standards would face a maximum penalty of 50,000 Yuan or a ban.
In addition to that, Decree 591 has given power to the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) or CIQ to conduct inspections on imported & exported hazardous chemicals and their packages at ports. SDSs and labels are main things checked by CIQ. Non-compliant SDSs and labels may result in a delay of customs clearance or returned goods.
