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China’s Ministry of Environmental Protection (MEP) promulgated “Measures on Environmental Management of New Chemical Substances” (MEP Order No. 7, also called China REACH) which came into force on 15th October 2010. The regulation bears some similarities with EU REACH but in practice the two systems are very different. In this article the major differences are outlined.
Firstly, both regulations have data requirements that include submission of (i) complete datasets and (ii) datasets modified by using specific rules for exemption. Under China REACH, the data waiver rules are simpler and more defined than the corresponding rules of EU REACH. For example, under China REACH, the acute earthworm toxicity study is only required if the following conditions are satisfied: the water solubility of a new chemical substance is below 1.0 mg/L and the n-octanol/water partition coefficient (log Kow) is above 3.5. However, under EU REACH you need to provide justification of whether there is likely to be direct and indirect exposure to the soil compartment.
Secondly, several eco-toxicological tests must be conducted on Chinese test organisms in accredited MEP -approved Chinese laboratories. For example, for organic substances, the acute fish toxicity and readily biodegradable tests are the minimum requirements that must be provided by a Chinese laboratory. The specific tonnage band will dictate what the data requirements are i.e. the principle of ‘the greater the tonnage, the greater the data required’ applies (Article 11). Therefore, if the amount of chemical exported to China is relatively high, other eco-toxicological tests will need to be carried out in accredited Chinese laboratories.
Thirdly, in common with EU REACH, a risk assessment report is required to be carried out by companies submitting a notification. It aims to meet both the obligation purpose and to decide whether some standard dataset may be waived. For example, long term toxicity test will not be conducted because risk is proved to be controllable based on CSA calculation by short term toxicity in certain case. However, for risk assessments performed under China REACH, waiving of certain data requirements are not acceptable i.e. you cannot waive the relative endpoint based on the results of the risk assessment report.
There are several other specific data requirements, some of which are only available by contacting the Chinese authorities directly or some experienced local agencies which are very familiar with these procedures. If you export products to China which may contain substances that require notification, or if you require more information on China REACH, please contact us for more details.
