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Data Requirements under China REACH and EU REACH: What are the Similarities and what are the Differences?

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It could easily forecast that the chemical management systems of more and more countries are/will be changed with forcing by the globalised nature of the chemicals industry to introduce similar controls of EU REACH regulation. In order to adapt new situation of environmental protection, china’s Ministry of Environmental Protection (MEP) promulgate “Measures on Environmental Management of New Chemical Substances” (No. 7, also called China REACH) instead of the older version in 2009. Now, it already came into force since 15th October 2010.

 

All companies are obliged to notify new chemical substances, which are not listed on the IECSC, to the Chemical Registration Centre (CRC) before they are exported to China. In common with the submission of EU REACH registration dossiers, datasets are also required to support China REACH notification applications. If you are familiar with both regulations, you will find that the data requirements overlap in some cases, but there are also several distinct differences.

 

Firstly, both regulations have data requirements that include submission of (i) complete datasets and (ii) datasets modified by using specific rules for adaptation. 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 1.00 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 a 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 controlled based on CSA calculating 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 agency who is very familiar with these process. 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.

Last Updated on Friday, 04 January 2013 03:54

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