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Regulating Nanotechnology in the European Union
Volume 3, Issue 3

Geert van Calster, K.U. Leuven, Belgium

Concerning the regulation of nanotechnology, the presumption is that the E.U. will adopt a cautious approach, whether or not based on regulation currently in place. Much like in the U.S. and elsewhere, there is no tailor-made regulatory framework for nanotechnology that currently exists in the E.U. Some in the industry fear that Registration, Evaluation, Authorization, and restriction of Chemicals (“REACH”), the new E.U.’s chemical policy, may be used as a source of inspiration for the regulation of nanotechnology, which might imply a qualified shift of the burden of proof with regard to safety, from the authorities to the manufacturer. Product liability law is less likely to play a preponderant role, at least at the E.U. level (as opposed to within the individual Member States) because the E.U.’s harmonization in this field of practice is limited. In this article, Geert van Calster provides an overview of current and future E.U. regulation of nanotechnology, with some comparisons between the E.U. and U.S. regulatory frameworks.

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