HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 97/28
EN
Official Journal of the European Union
12.4.2011
DIRECTIVES
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,
(5) The
measures
provided
for
in
this
Directive
are
in
accordance with the opinion of the Committee set up
Having regard to the Treaty on the Functioning of the European
by Article 28 of Directive 2002/98/EC,
Union,
HAS ADOPTED THIS DIRECTIVE:
Having regard to Directive 2002/98/EC of the European
Article 1
Parliament and the Council of 27 January 2003 setting
standards of quality and safety for the collection, testing,
Annex V to Directive 2004/33/EC is amended in accordance
processing, storage and distribution of human blood and
with the Annex to this Directive.
blood components and amending Directive 2001/83/EC ( 1 ),
and in particular point (f) of the second paragraph of
Article 2
Article 29 thereof,
1. Member
States
shall
bring
into
force
the
laws,
regulations
and administrative provisions necessary to comply with this
Whereas:
Directive by 30 June 2011 at the latest. They shall forthwith
communicate to the Commission the text of those provisions
(1) Point
2.4
of
Annex
V
to
Commission
Directive and a correlation table between those provisions and this
2004/33/EC of 22 March 2004 implementing Directive
Directive.
2002/98/EC of the European Parliament and of the
Council as regards certain technical requirements for
When Member States adopt those provisions, they shall contain
blood and blood components ( 2 ) sets minimum (6,4)
a reference to this Directive or be accompanied by such a
and maximum (7,4) pH levels for units of platelets at
reference on the occasion of their official publication. Member
the end of the shelf life. Therefore, platelet units that
States shall determine how such reference is to be made.
do not meet these minimum or maximum values have
to be discarded.
2. Member
States
shall
communicate
to
the
Commission
the

text of the main provisions of national law which they adopt in
(2) Recent
scientific
evidence
and
field
practice
experience the field covered by this Directive.
has demonstrated that values higher than pH 7,4 do
Article 3
not affect the quality and safety of stored platelets,
contrary to pH levels below 6,4 that systematically
This Directive shall enter into force on the day following its
result in damaging the platelets, and that a maximum
publication in the Official Journal of the European Union.
pH value for platelet concentrates is thus not necessary.
Article 4
(3) Discarding
platelets
that
exceed
the
maximum
pH
value This Directive is addressed to the Member States.
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
Done at Brussels, 11 April 2011.
shelf life.
For the Commission
(4) Therefore
the
maximum
(7,4)
pH
value
for
all
platelet
concentrates listed in Annex V to Directive 2004/33/EC
The President
should be removed.
José Manuel BARROSO
( 1 ) OJ L 33, 8.2.2003, p. 30.
( 2 ) OJ L 91, 30.3.2004, p. 25.

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EN
12.4.2011 Official
Journal
of
the
European
Union L
97/29
ANNEX
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’.

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