On 21 May 2009 the Ministry of Environment Protection of China launched the closed inter-ministries consultation on the proposed amendments to the Measures on the Environmental Control of New Chemical Substances. The proposed Measures contain provisions impacting and likely disadvantaging foreign companies to a large extent.
Amongst others, the most significant changes are as follows:
– A risk management concept for new chemicals in the Chinese chemical control system, i.e. hazard and
– Chemicals would be classified into three categories, i.e. general chemicals, hazardous chemicals, and
chemicals of environmental concern
– Basics of notification and registration system for new chemicals would remain the same as it was.
However, detailed ‘general notification’ would be required for new chemicals depending on tonnage (e.g. 1
ton, 10 tons, 100 tons, 1,000 tons) of the chemicals imported or produced. The principle of notification
information would be ‘higher volume, more information request’.
– Simplified notification would be available for new chemicals imported or produced less than 1 ton per year.
Separate research and development notification would be available when producing or importing a new
chemical substance less than 0.1 ton per year.
– Notification of new chemicals would only be done by a registered Chinese entity.
– ‘Joint notification’ would also be possible under the concept of ‘Easy Notification’.
– In case of a producer or an importer who has registered hazardous chemicals or chemicals of
environmental concern, s/he would have to prepare and submit an annual production or import report and an
annual production or import plan to the Chemical Registration Centre.
The most potentially problematic issues for foreign chemical manufacturers or exporters are that:
– Only China-generated ecotoxicological data would be acceptable for registration;
– Harmony between registration through Chinese entities only and CBI protection would be difficult.