China has updated its chemical registration rules, to bring the country in line with other countries
Hepeng Jia/Beijing, China
After a seven-year delay, China has introduced an updated version of its chemical registration and evaluation rules, bringing the country in line with chemical regulation efforts in other parts of the world.
In January, the Chinese Ministry of Environmental Protection (MEP) released the amended new chemical notification scheme, Measures on Environmental Management of New Chemical Substances, otherwise known as Order 7.
The new rules will take effect on 15 October with guidance documents to be published between April and July.
’The new regulation is intended in part to align China with other leading regulatory schemes such as the system in the US and EU,’ according to an analysis report issued by Washington DC-based law firm Bergeson & Campbell. The registration, evaluation, authorisation and restriction of chemical substances (Reach) legislation became law in Europe in 2007 in an attempt to obtain more detailed information on the properties of chemical substances used across the region.
The previous version of China’s new chemical substance regulation was issued in 2003.
Both the 2003 and the new regulations ask that traders, manufacturers and users in China to register with the MEP any new chemical substances in their products that are not already listed on the inventory of existing chemical substances manufactured or imported in China (IECSC). The amendment stresses the need to evaluate the real and potential environmental and human health risks of registered substances. It also classifies chemical compounds into three categories: general new chemical substances, hazardous new chemical substances, and key hazardous new chemical substances.
According to the Bergson & Campbell report, the new rule also introduces the principle of ’higher volume, more data’, which requires traders and manufacturers to provide more information on chemical structures, environmental impacts and health effects or potential harms for chemicals used in larger amounts.
Out of the blue
Although the previous version of the legislation has been in effect for seven years, most chemical manufacturers in China are unaware of its existence. According to a report by China Chemical Industry News, more than 100,000 chemical substances are commercially used worldwide. And even though most of those are used in China, so far only 40,000 are recorded on the IECSC.
Even during 2009 when registrations were at their peak, only about 4,500 of the tens of thousands of organisations in China registered their chemical substances with the MEP, and most were foreign-backed firms, says Zhou Houyun, editor in chief of the Chinese journal Chemical Safety and Environment, who has been working closely with industry on the chemicals regulation.
As most Chinese chemical producers do not have the capacity to develop new chemicals, they are not aware of the need to register them, explains Zhou, who adds that insufficient publicity, lack of sanctions and low participation of local environmental agencies all contribute to low engagement of the Chinese chemical sector with the regulations.
’But Reach has increased awareness, and in the new rules, a greater law enforcement role has been given to local environment watchdogs, promoting them to implement the measures more actively,’ Zhou told Chemistry World.
While the cost of assessing environmental and health risks could make smaller players reluctant to comply with registration, firms with a stronger international background should easily accommodate it, as aside from two experiments for ecological and health toxicology, all other required information can be cited from data held by other internationally authoritative institutions.
’The requirement for more data for higher volumes of substance could be a real challenge, as many Chinese manufacturers produce large amounts of chemicals for which they lack the ability to register their substances,’ says Zhou.
If strictly implemented, the rules will add considerable costs and challenges for smaller or low-capacity chemical companies while larger competitors could benefit, especially if it prompts a wave of industrial consolidation, Zhou adds.