REGULATION & COMPLIANCE
for industrial purposes other than permitted uses , applicants should carry out a new registration for these uses , even when the substances are already on the IECSC . To determine if this is needed , you should look at the IECSC , where there will be a remark under the name of the substance listing permitted uses . For highly hazardous chemical substances , new applicants are required to register for new uses for any purpose . If the substances are intended for use in industrial purposes other than permitted uses by the original applicants , the original applicants should register for new uses .
Hazardous chemical management
Hazardous chemicals have been subject to ever-tighter regulation since 2010 , when Decree Order 591 , the main law for regulating existing chemicals and implementing the GHS in China , came into force . This has since been supplemented by SAWS Orders 53 and 60 , which laid down measures for the registration of hazardous chemicals and the identification and classification of the physical hazards of chemicals . As well as registering these chemicals , you may , depending on your business activity , need to consider SAWS Orders 41 and 55 , which cover manufacturing and operating licences . In addition , if your substance is included in the Catalogue of Hazardous Chemicals of 2015 , by virtue of being toxic or a precursor , for example , it will be subject to further management requirements . Hazardous chemicals are defined as “ highly toxic chemicals and other chemicals which are toxic , corrosive , explosive , flammable and do harm to the human body , facilities and the environment ”. Chemicals meeting GHS hazard classification criteria and within 81 categories among 28 GHS classifications are regarded as hazardous under Decree 591 . Only a Chinese legal entity can carry out a registration of a hazardous chemical . For overseas companies , this can be their importer . The registration must include a domestic 24-hour
Figure 3 - Minimum data requirements for registration
emergency number and a GHS safety data sheet and label . Registrations are made to the Ministry of Emergency Management ’ s National Registration Centre of Chemicals . In 2021 , the ‘ One company , one product , one code ’ concept was piloted . According to the authorities , this has been very successful . As yet , we do not know when it will be fully implemented but several provinces are implementing it already . This is basically a QR code that is given to a company when it does its hazardous chemical registration . When customs scan the outside of the package for a chemical substance destined for China , they will be able to link up the GHS information with the hazardous chemical registration and check if both have been done . Hazardous chemical licence requirements regarding manufacture , safe use and operations are defined by SAWS Orders 41 , 57 and 55 respectively . The exact licence requirements depend upon the nature of your business in China . The application process for licences also needs to be carried out by a Chinese legal entity . At a national level , China is making changes to its laws . The MEM sent a draft Hazardous Chemicals Safety Law for public comment in October 2020 . Among proposed changes are :
• Clarifying the division of responsibilities of different competent authorities
• More detail on regulatory requirements on manufacturing , storage , operation , use , transportation and disposal of hazardous chemicals
• Exemption of hazardous chemicals used for R & D , trial production and trial marketing , and with low exposure , low release , etc . from registration
• Optimisation of the licence system
• Establishing an information monitoring system to improve the management level of hazardous chemicals
• Adding a chapter on waste disposal safety Similarly , MEM sent out a draft Guidance on Implementation for Catalogue of Hazardous Chemicals in August 2020 . Proposed changes in this include :
• No hazardous chemical operation license needed for the sale of solid CO 2
• Clarifying that the hazardous chemicals that need to complete the licence are the hazardous chemicals included in the catalogue .
• Unify the naming format for hazardous chemicals not listed in item 2828 in the catalogue when applying for relevant licences The aim in both cases is to simplify the procedures for companies wanting to manufacture in or import into China . •
J j
Julie Harrington
REGULATORY CONSULTANT
CIRS EUROPE Julie @ cirs-reach . com www . cirs-group . com / en
44 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981