HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 327/24
EN
Official Journal of the European Union
27.11.2012
DIRECTIVES
COMMISSION DIRECTIVE 2012/39/EU
of 26 November 2012
amending Directive 2006/17/EC as regards certain technical requirements for the testing of human
tissues and cells
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
ensure a more consistent implementation of the HTLV-I
testing requirements across the Member States.
Having regard to the Treaty on the Functioning of the European
Union,
(4) Point
4.2
of
Annex
III
to
Directive
2006/17/EC
requires
that blood samples must be obtained at the time of each
Having regard to Directive 2004/23/EC of the European
donation both, for partner donation (not for direct use)
Parliament and of the Council of 31 March 2004 on setting
and for non-partner donation of reproductive cells.
standards of quality and safety for the donation, procurement,
testing, processing, preservation, storage and distribution of
human tissues and cells (
(5) As
far
as
partner
donation
of
reproductive
cells
is

1 ), and in particular point (e) of the
Article 28 thereof,
concerned, recent scientific evidence has demonstrated
that requiring testing at fixed time intervals up to a
maximum of 24 months would not diminish the level
Whereas:
of safety of the cells concerned as long as appropriate
safety and quality systems are in place in tissue estab
lishments using Assisted Reproductive Technology, in
(1) Commission
Directive
2006/17/EC
of
8
February
2006
accordance with Article 16 of Directive 2004/23/EC.
implementing Directive 2004/23/EC of the European
During these time intervals, the results of the previous
Parliament and of the Council as regards certain
test carried out on the same donor can be relied upon.
technical requirements for the donation, procurement
and testing of human tissues and cells ( 2 ) requires that
HTLV-I antibody testing must be performed for donors
(6)
Whereas testing at the time of each donation does not
living in, or originating from, high-incidence areas or
improve the safety of reproductive cells donated between
with sexual partners originating from those areas or
partners, field practice experience shows that this
where the donor’s parents originate from those areas.
requirement is costly and cumbersome for both,
This testing is required both for donors of reproductive
patients and healthcare systems. In order to act in a
cells, in accordance with Annex III to Directive
more proportionate manner to the safety objective
2006/17/EC, and for other donors, in accordance with
pursued, it is therefore appropriate to allow the
Annex II thereof.
Member States to require testing at fixed time intervals
which they may determine up to a maximum of 24
(2) Recent
scientific
evidence
provided
by
the
European
months instead of at the time of each donation.
Centre for Disease Prevention and Control (ECDC) and
field practice experience showed that it is very difficult, in
the current state of scientific knowledge, to determine
(7) The
measures
provided
for
in
this
Directive
are
in
what is an HTLV-I high-incidence area. This testing
accordance with the opinion of the Committee set up
requirement is thus not implemented in a uniform
by Article 29 of Directive 2004/23/EC,
manner.
HAS ADOPTED THIS DIRECTIVE:
(3) ‘Incidence’
measures
the
rate
of
occurrence
of
new
cases
of a disease or condition, while ‘prevalence’ is the
proportion of a population that is affected by a particular
Article 1
disease at a specific time. In practice, data for prevalence
are more available than data on incidence. In addition,
Annexes II and III to Directive 2006/17/EC are amended in
prevalence is a more relevant measure than incidence
accordance with the Annex to this Directive.
when assessing the impact of a chronic disease within
a community and to assess the subsequent needs. It is
Article 2
therefore appropriate to replace references to high-
incidence by references to high-prevalence in order to
1. Member
States
shall
bring
into
force
the
laws,
regulations
and administrative provisions necessary to comply with this
( 1 ) OJ L 102, 7.4.2004, p. 48.
Directive by 17 June 2014 at the latest. They shall forthwith
( 2 ) OJ L 38, 9.2.2006, p. 40.
communicate to the Commission the text of those provisions.

---

EN
27.11.2012 Official
Journal
of
the
European
Union L
327/25
When Member States adopt those provisions, they shall contain
Article 4
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
This Directive is addressed to the Member States.
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
Done at Brussels, 26 November 2012.
the field covered by this Directive.
Article 3
For the Commission
This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
The President
European Union.
José Manuel BARROSO
ANNEX
Annexes II and III to Directive 2006/17/EC are amended as follows:
(1) in Annex II, point 1.2 is replaced by the following:
‘1.2. HTLV-I antibody testing must be performed for donors living in, or originating from, high-prevalence areas or
with sexual partners originating from those areas or where the donor’s parents originate from those areas’;
(2) Annex III is amended as follows:
(a) point 2.4 is replaced by the following:
‘2.4. HTLV-I antibody testing must be performed for donors living in, or originating from, high-prevalence areas
or with sexual partners originating from those areas or where the donor’s parents originate from those
areas’;
(b) point 3.3 is replaced by the following:
‘3.3. HTLV-I antibody testing must be performed for donors living in, or originating from, high-prevalence areas
or with sexual partners originating from those areas or where the donor’s parents originate from those
areas’;
(c) point 4.2 is replaced by the following:
‘4.2. For donations other than by partners, blood samples must be obtained at the time of each donation.
For donation by partners (not for direct use), blood samples must be obtained within three months before
the first donation. For further partner donations by the same donor, further blood samples must be
obtained according to national legislation, but no later than 24 months from the previous sampling.’.

---

Document Outline

• �

---