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On 19 Jan 2010 the Ministry of Environment Protection of China (MEP) launched the final version of "Measures on the Environmental Management of New Chemical Substances", also dubbed as "China REACH") and announced that the "Measures" would be implemented from 15 October, 2010. The "Measures", also called "China REACH", contains provisions impacting foreign companies and is likely to place them at a significant disadvantage.
Among the related terms, the most significant changes in the newly launched Measures are as follows:
Requirement of a risk assessment report for new chemicals in the Chinese chemical control system, which includes information on hazard and exposure evaluation, as well as risk control conditions;
Notification of new chemicals can be processed only by a registered Chinese entity, and only eco-toxicological data from a small list of pre-approved labs in China will be accepted;
Classification of chemicals into three management categories: general chemicals, hazardous chemicals, and chemicals of environmental concern;
Requirements of general notification of new chemicals imported or produced in China for different tonnage bands (1-10 ton, 10-100 tons, 100-1000 tons, +1,000 tons) adhere to the principle "higher volume, more information requested". Furthermore, "joint notification" is viable;
Simplified notification of new chemicals is required even if the imported or produced volume is less than 1 ton per year in China;
Separate research and development notification would be required when producing or importing a new chemical substance at less than 0.1 ton per year;
In the case of a producer or an importer who has registered hazardous chemicals or chemicals of environmental concern, they would have to prepare and submit an annual production or import report and an annual production or import plan to the Chemical Registration Center (CRC).
The most potentially problematic issues for foreign chemical manufacturers or exporters are that:
Only China-generated eco-toxicological data would be acceptable for notification.
Joint-notification is viable by Chinese entities only, therefore protecting confidential information may be difficult.
Penalties for non-compliance are high, which also include reputation damage due to the public notification on the CRC-MEP's website.
As mentioned above, more information will be required for notification under the revised "Measures", which implies more efforts and financial input be required of the the companies involved. However, the new chemicals notification under the old Measure doesn't need to be updated, even after the revised "Measures" comes into force on 15 Oct, 2010. Therefore, it's better to notify now under the old Measures if any company plans to export new chemicals to China in the near future.
