A study on the support method of the act on registration and evaluation, etc. of chemical substances (ARECs) by analyzing EU REACH test data
- Author Park, Jeonggue
- Researchers Gan, Sunyeong
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Date
2016-11-30
This study examines the registration experience of EU REACH over the last 8 years, and suggests policy recommendations to ensure that the Act on Registration and Evaluation, etc. of Chemical Substances (ARECs) is implemented smoothly by solving the difficulties of producing high-cost test data. The policy suggestions are as follows:
o Gaining expertise / experience in alternative testing
Contrary to what was expected in Korea, a large number of alternative test methods were submitted for all the test items in the first and second registration of the EU. Especially, about half of the items with high test cost such as repetitive toxicity and reproductive toxicity were used so much that alternative test data were submitted. Domestic registrants are mainly interested only in QSAR, but in the EU, there is a lot of data produced through read-across and evidence weights. Registrants and evaluators have no experience or expertise in these alternative testing methods. Thus, in order for the alternative testing method, such as the EU, to be used in the first registration of ARECs, it is necessary to first expand the legal basis for the alternative testing method and distribute casebooks, so that they can acquire expertise quickly and gain sufficient experience.
o A clear conceptual set of evidence weights
The domestic legal basis for the weight of evidence used actively in the EU is not clear, while the proportion of evidence weighted use in some items such as genotoxicity exceeds 20% in the EU. The EU has defined the concept of weight of evidence in Annex o of the REACH Regulation.
o Gaining expertise / experience in alternative testing
Contrary to what was expected in Korea, a large number of alternative test methods were submitted for all the test items in the first and second registration of the EU. Especially, about half of the items with high test cost such as repetitive toxicity and reproductive toxicity were used so much that alternative test data were submitted. Domestic registrants are mainly interested only in QSAR, but in the EU, there is a lot of data produced through read-across and evidence weights. Registrants and evaluators have no experience or expertise in these alternative testing methods. Thus, in order for the alternative testing method, such as the EU, to be used in the first registration of ARECs, it is necessary to first expand the legal basis for the alternative testing method and distribute casebooks, so that they can acquire expertise quickly and gain sufficient experience.
o A clear conceptual set of evidence weights
The domestic legal basis for the weight of evidence used actively in the EU is not clear, while the proportion of evidence weighted use in some items such as genotoxicity exceeds 20% in the EU. The EU has defined the concept of weight of evidence in Annex o of the REACH Regulation.