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China's existing Regulation for chemical substances refers to the Measures on the Environmental Management of New Chemical Substances, which was issued by the State Environmental Protection Administration (SEPA) of the Ministry of Environmental Protection (MEP) on September 12, 2003 and became effective on October 15, 2003.
The revised version of Measures on the Environmental Administration of New Chemical Substances has been dubbed 'China REACH' since it draws on many similar elements of REACH, particularly those concerning risk assessment, risk management and data submission.
China REACh - Version 2010, adopted on 30 December 2009 and published in January 2010, will come into effect from 15 October 2010. After that, the old Regulation issued on 12 September 2003 will be superceded by the new Measures. It will affect all production activities, import and export of the new chemicals in China. It would expand China's existing regime for new chemical substances by increasing the volume and complexity of data that must be supplied to the authorities before import or production. The manufacture, import or use of a new chemical substance will be expressly prohibited if these new chemical substances are not properly notified.
China REACh, like the 2003 Measures, applies only to substances that are not listed on the Inventory of Existing Chemical Substances Produced or Imported in China (IECSC). There were 45,355 substances listed on the IECSC in 2010. It is clear that an eco-toxicological test report included in the notification dossier (where required) must include testing data using Chinese target organisms within the territory of the People's Republic of China. Use of Chinese laboratories will therefore be mandatory in most cases. Notification of new chemical substances can only be carried out by a registered Chinese entity.
Although to describe the revised version of Measures on the Environmental Management of New Chemical Substances as "China REACh" is probably to overstate the case, it does represent a significant step towards introducing a REACh-style regime in China.
It is unlikely to mark the end of China's efforts to strengthen its chemical safety regime, particularly since it is administered by the new Ministry of Environmental Protection - a powerful 'super-ministry' created in 2008 from the State Environmental Protection Administration. Regulatory trends in such an important market will no doubt be watched with interest by all chemical companies. Sufficient understanding and an acute grasp of the real-time developments of China REACh will be of great assistance in furthering a company's trading activities in China.
It's clear that China REACh compliance is a strategic business issue; therefore it s of great importance for companies that have entered or are about to enter China market to ensure their products abide by China's chemicals regulations.
