Chemical management in China: More complex than in the EU
The New Chemical Substance Notification in China is often called China REACH due to the similarities with its European counterpart. We spoke to Christine Chuang of the Chinese chemical management consulting firm Chemical Inspection and Regulation Service (CIRS) about China REACH and what chemical companies have to take into account when they become active on the Chinese market.
What would you say are the main differences between the framework of chemical legislation in China and Europe?
CIRS: The framework of chemical legislation in China is more complex than in the EU. In the EU, REACH is in control of all new chemicals and existing chemicals, the primary responsible authority is the European Chemicals Agency (ECHA). In China, meanwhile, lots of Chinese authorities are involved in chemical management. There are laws published by the Peoples’ Congress; regulations and ordinances published by the State Council and Ministries; the Implementation Measure/Guideline published by ministries; Standards (National Compulsory Standards) published by the Standard Administration Commission. The most two important authorities are the Ministry of Ecology and Environment of the People’s Republic of China (MEE) and Ministry of Emergency Management of the People’s Republic of China (MEM). Under the Chinese chemical legislation framework, New Chemical Management requires compliance with MEE Order No.7, the safety management of hazardous chemicals requires compliance with the State Council Decree 591 which contains several tiers. Due to various catalogues and classification, each role has different obligations (registration, license, permission, China GHS etc.) that are required during the production and the supplier chain.
The New Chemical Substance Notification is often called “China REACH”. How similar is it to the REACH regulation employed in Europe?
Christine Chuang
CIRS
CIRS: Actually, “China REACH” is not an official name. What we call “China REACH” is specific to the “New Chemical Notification in China”. The similarities between these two regulations as follow:
-Notification entity: Only domestic manufacturers and importers can act as a notified body. Foreign companies could appoint an Only Representative (OR) on their behalf.
– Notification scope: The registration requirements apply to chemical substances, substances in preparation and substances that exist in articles which intended to be released.
– Data requirement: The data requirement depends on the substance volume. It increases with different tonnage bands.
– Risk assessment. For higher tonnage registered substances, hazard assessments are required and a risk assessment report shall be developed according to their use and exposure scenarios.
Since the “Revision of MEP Order 7th” will come out soon, there will be some update requirements of New Chemical Substance Notification in China.
Can you expand on hazardous chemical management in China?
CIRS: In China, hazardous chemicals are mainly regulated by the State Council Decree 591 Regulations on Safe Management of Hazardous Chemicals issued in 2011. Along with the Catalogue of Hazardous Chemicals (2015) and other catalogues including Toxic Chemicals, Prohibited Chemicals, Priority Management and Special Purpose. The domestic company/plant that manufacture/processing or operating hazardous chemicals in catalogues are subject to various of license requirements. In addition, Decree 591 requires domestic manufacturers and importers who handle hazardous chemicals in China to submit Hazardous Chemical Registrations and provide SDSs and labels meet the China GHS national standards.
What are the main challenges for chemical companies who want to become active on the Chinese market?
CIRS: Based on our understanding and experience, here are a few guide lines:
– In China, multiple ministries are involved in chemical management. Chemicals in China are controlled under several layers of laws and regulations, including decrees, orders, and technical standards.
– Due to the geography of China, different regions could have different understanding of the chemical regulations. You would need to communicate separately with different customs or local departments.
– Another feature is that there is limited access to comprehensive supporting guidances and lack of an official data sharing platform, chemical companies have to finish the whole registration/notification by fulfilling demanding data requirements individually and obtain final certificate/license before actual activities.
– Like all companies doing business in China, there is always language barriers and culture difference. Work step by step, be patient on making decisions.
Christine Chuang will also present on the subject of chemicals management in China at the European Coatings Regulatory Forum on 27 and 28 November in Brussels. Other topics will include restrictions on titanium dioxide and diisocyanates, Brexit and much more.
What should companies take into account when transporting dangerous goods to China?
CIRS: Regarding the transport of hazardous chemicals, companies should at first judge whether the hazardous chemicals are dangerous goods by inquiring the List of Dangerous Goods (GB 12268-2012); then companies should judge whether the dangerous goods can be transported in limited quantities or excepted quantities based on the quantities of dangerous goods for transport as well as the Excepted Quantities and Packing Quantities of Dangerous Goods (GB 26844.1-2012) and Limited Quantities and Packing Requirements of Dangerous Goods (GB 26844.2-2012).
Based on these judgements, companies should select suitable packing materials for package, for instance, whether the dangerous need to be packaged in UN specification packages and if the dangerous goods are appropriately marked and labelled. Other points that need to be taken into account is f the dangerous goods can be packaged in excepted quantities and limited quantities for transport; at last, companies should choose a transport unit with relevant transport qualifications for their dangerous goods.
