Little Pro on 2015-12-30
Regulations on Safe Management on Hazardous Chemicals (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 China 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 hazardous chemicals ("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 ("GHS in China").
The picture below shows the main requirements of Decree 591 and relevant supporting ministerial regulations and standards.
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, more than 2800 chemicals have been added to the Catalogue of Hazardous Chemicals. This Catalogue is an administrative license Catalogue. Businesses who handle hazardous chemicals in the Catalogue are subject to various license requirements.
It shall be noted that some hazardous chemicals in the Catalogue belong to highly toxic chemicals, explosives precursors and priority hazardous chemicals for environmental management and are subject to more stringent requirements.
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:
*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).
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.
It shall be noted that this HazChem registration is required for both hazardous substances and mixtures regardless of whether they are included in the Catalogue or not. There is no small volume exemption either.
China MEP order 22 was revoked on 15 July 2016 (source). Companies no longer need to register hazardous chemicals with environmental protection authorities.
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.
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