The Commission has decided to refer Italy to the Court of Justice of the EU for its failure to notify the transposition measures of EU rules which amends the existing requirements applicable to the testing of human tissues and cells (Commission Directive 2012/39/EU). These amendments are crucial for all involved parties and in particular for the donors and the donors' family in the context of setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. To date, Italy has not notified the Commission of the measures transposing this amending Directive into national law, despite being required to do so by 17 June 2014.
The Commission addressed a letter of formal notice to Italy in July 2014, and a reasoned opinion in February 2015, urging it to notify the transposition measures of Commission Directive 2012/39/EU. This Directive amends the existing requirements laid down in Directive 2006/17/EU which Italy had transposed into its legislation. However, Italy has not complied with the Commission's reasoned opinion yet.
For more information
-On the key decisionsofthe May 2018 infringements package, please refer to the full MEMO/18/3446.
-On the general infringements procedure, see MEMO/12/12.
-On the EU infringements procedure.