While the obligation to notify studies under this Regulation should apply in the context of all the Union legal acts on chemicals listed in Annex I, Part 1, the various relevant data collection and safety assessment processes under those acts can vary widely procedurally. The overarching aim of the database of study notifications established under this Regulation should be to bring together information on studies on chemicals being commissioned by business operators, so as to make it possible to have a centralised and complete overview of the studies being performed to support an application, notification or regulatory dossier intended to be notified or submitted to an Authority, as well as any studies on chemicals on their own or in products, that business operators commission as part of a risk or safety assessment, to ensure compliance under the Union legal acts listed in Annex I. Given that objective and considering the fact that assessment processes under Union legal acts on chemicals listed in Annex I can vary widely, it would be beyond the scope and aims of this Regulation to amend those processes set out under the Union legal acts listed in Annex I by imposing additional conditions for those processes leading to potential consequences on market access not envisaged in those Union legal acts. Consequently, it is not appropriate, in this Regulation, to provide for consequences associated with non-compliance with the obligation to notify studies as those provided for in Article 32b of Regulation (EC) No 178/2002 for non-compliance with the obligation to notify studies under that Regulation.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
