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China's REACH: new chemical registration and evaluation

China's REACH: new chemical registration and evaluation

30-May-11
China has updated its chemical registration and evaluation rules. This was announced by Chinese Ministry of Environmental Protection (CMEP) in January 2010.
China's existing Regulation for chemical substances refers to the Measures on the Environmental Administration 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 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 After that, the old Regulation issued on 12 September 2003 will be superceded by the new Measures.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 on 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 that had not been properly notified is expressly prohibited.
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.
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. It is clear that China REACH compliance is a strategic business issue; therefore it is of great importance for companies that have entered or are about to enter China market to ensure their products abide by China's regulations on the control of chemical:
1. 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
2. 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
3. Classification of chemicals into three entities only, therefore protecting categories: general chemicals, hazardous chemicals and chemicals of environmental concerns
4. Requirement 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); the principle of notification information would be �higher volume, more information requested. Furthermore �joint notification" is viable here
5. Simplified notification of new chemicals is required even if the imported or produced volume is less than 1 ton per year in China
6. Separate research and development notification would be required when producing or importing a new chemical substance less than 0.1 ton per year
7. 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
a. Only China-generated eco-toxicological data would be acceptable for registration
b. Joint-notification is viable by Chinese entities only, therefore protecting confidential information may be difficult
c. Penalties for non compliance are high
More information will be required for notification under the new Measures, which implies more efforts and costs will be put on the related companies. However, the new chemicals notification under the old Measure doesn't need to be updated even after the new one comes into force after 15 Oct, 2010. Therefore, it is better to notify now under the old Measures if any company plans to export new chemicals to China in future.
(Source Courtsey: reach24h.com)
 
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