- Latest available (Revised)
- Point in Time (31/01/2020)
- Original (As adopted by EU)
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)
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).
EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2002/98/EC of the European Parliament and the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC(1), and in particular point (f) of the second paragraph of Article 29 thereof,
Whereas:
(1) Point 2.4 of Annex V to Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components(2) sets minimum (6,4) and maximum (7,4) pH levels for units of platelets at the end of the shelf life. Therefore, platelet units that do not meet these minimum or maximum values have to be discarded.
(2) 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.
(3) 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.
(4) Therefore the maximum (7,4) pH value for all platelet concentrates listed in Annex V to Directive 2004/33/EC should be removed.
(5) 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:
Annex V to Directive 2004/33/EC is amended in accordance with the Annex to this Directive.
1.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2011 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
This Directive shall enter into force on the day following its publication in the Official Journal of the European Union.
This Directive is addressed to the Member States.
Done at Brussels, 11 April 2011.
For the Commission
The President
José Manuel Barroso
In point 2.4 of Annex V to Directive 2004/33/EC, for the entries:
‘Platelets, apheresis’,
‘Platelets, aphaeresis, leucocyte-depleted’,
‘Platelets, recovered, pooled’,
‘Platelets, recovered, pooled, leucocyte-depleted’,
‘Platelets, recovered, single unit’, and
‘Platelets, recovered, single unit, leucocyte-depleted’,
the acceptable results for quality measurements for pH are replaced by the following:
‘Minimum 6,4 corrected for 22 °C, at the end of the shelf life’.
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.
The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.
For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: