Six years after the issuance of Measures on Environmental Administration of New Chemical Substances (“2003 Measures”), the Chinese Ministry of Environmental Protection has recently launched an interministerial consultation on a proposed amendment (“Amendment”) that could become effective in October 2010. The 2003 Measures require manufacturers and importers to notify and register new chemical substances with the Chemical Registration Centre (the “CRC”) of the Ministry of Environmental Protection. The Amendment imposes substantially more obligations in the areas of data collection and environment protection.
The Amendment is inspired by EU’s REACH1 system for the notification of new chemicals and increases requirements for the control and safety of chemicals to be manufactured or imported into China.
The main features of the Amendment are as follows:
- The Amendment applies only to new chemicals, i.e. substances other than the approximate 45,000 listed in the Catalogue of Existing Chemical Substances. Current participants in the Chinese chemical sector should, therefore, not be immediately affected.
- The Amendment introduces a classification system whereby any new chemical substance should be regarded as “General,” “Hazardous,” or “Of Concern for Environment.”
- Higher volumes would trigger greater requirements in terms of testing and data.
- The Amendment introduces simplified procedures for low volumes (less than 1 ton manufactured/imported each year) scientific research (less than 0.1 ton manufactured/ imported each year) and certain polymers.
- It appears that only China registered entities would be entitled to apply for registration of new chemical substances.
- Most tests may only be carried-out by designated laboratories in China (in particular ecotoxicological tests).
- Various obligations in terms of labeling, packaging, transportation, and distribution apply to registrants and end users in order to manage risks of damage to health and the environment. The Amendment also provides for post-registration follow-up formalities.
- The Ministry of Environmental Protection and its local counterparts will be in charge of monitoring enforcement of the Amendment, with the power to impose financial penalties (in very limited amounts) and corrective measures.
Although experts praise the Amendment as a move of China towards a REACH system, many aspects of this regulation remain rather unclear and broadly drafted. On the enforcement side, it also remains to be seen whether China’s existing expertise and infrastructure can support a full scale implementation of the Amendment.
Finally, certain observers expressed fears that the Amendment could be used as a trade barrier to limit the import of foreign chemicals in China.