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European Commission - Press release

Commission calls on Italy to transpose the Directive on human blood

BRUSSELS, 24 November 2011 – Today the European Commission has formally requested Italy to communicate national measures implementing Directive 2011/38/EU which removes maximum pH values for platelets concentrates for blood and blood components at the end of the shelf life. Full implementation by Member States is essential to ensure high standards of quality and safety of human blood and blood components throughout the European Union. The Directive aims to improve the EU's self-sufficiency on blood and enhance confidence in the safety of the blood supply chain amongst EU countries.

Member States were expected to implement the Directive by 30 June 2011. To date Italy has not communicated the relevant implementing measures to the Commission.

Earlier this year the Commission initiated infringement proceedings - as foreseen by Article 258 of the Treaty on the Functioning of the European Union (TFEU) - by sending a letter of formal notice to Italy.

Today's request takes the form of a "reasoned opinion". The Commission asks Italy to ensure full compliance with the Directive within two months. If Italy does not comply within the deadline, the Commission may decide to refer the case to the European Court of Justice.

For more information on the infringement procedure, please see:


For more information on the blood legislation, please visit:

Contacts :

Frédéric Vincent (+32 2 298 71 66)

Aikaterini Apostola (+32 2 298 76 24)

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