Commission Implementing Directive 2011/38/EU
of 11 April 2011
amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf life
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
Recent scientific evidence and field practice experience has demonstrated that values higher than pH 7,4 do not affect the quality and safety of stored platelets, contrary to pH levels below 6,4 that systematically result in damaging the platelets, and that a maximum pH value for platelet concentrates is thus not necessary.
Discarding platelets that exceed the maximum pH value as set out in Annex V to Directive 2004/33/EC leads to considerable losses. These losses may increase in the future due to new collection methods and storage bags, which both generate higher pH values at the end of the shelf life.
Therefore the maximum (7,4) pH value for all platelet concentrates listed in Annex V to Directive 2004/33/EC should be removed.
The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 28 of Directive 2002/98/EC,
HAS ADOPTED THIS DIRECTIVE: