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Chemical Registration Changes Anticipated in China

04 02 10 - 00:45 In 2009 the Chinese Ministry of Environmental Protection (MEP) proposed changes to the notification of new chemical substances. The new regulation has been dubed China REACh, since it introduces a tiered system of testing and notification akin to the European REACh system. The legislative amendments are intended to only affect new chemicals after the adoption date...not chemicals already listed on the Inventory of the Existing Chemical Substances in China (IECSC). The law is expected to come into force in October 2010.

If adopted, the most significant aspects to China REACh will include the following:

• Reduced regulatory requirements (Simplified Notification) for substanced manufactured or imported at less than 1 metric ton per year. This will also include low-volume intermediates for export, low concern polymers and substances for scientific research and product development purposes (100-kg threshold).

• Tiered testing and notification at thresholds of manufacturing or importation of 1, 10, 100, and 1,000 tons

• Only Chinese-based entities may conduct the notification and testing of substances (e.g. registration agents and testing laboratories must be based in China).

• Companies will be required to report their activities and keep volume records after receiving the registration certificate (e.g. a first time activity report will be due to the Chemical Registration Center within 30 days of the first manufacture or import for each company supplied).

A registration package will need to include the notification application form, a testing report for all physicochemicical properties, as well as toxicitiy and ecotoxicity test results, an environmental assessment, classification/labeling categories and a Chinese MSDS.