Decision of the EEA Joint Committee No 81/2007 of 6 July 2007 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
Date: 2007-07-06
Institutions: EEA Joint Committee
Subjects: cytology, exchange of information, health policy, health risk, medical examination, public health, quality standard, safety standard, traceability

13.12.2007

EN

Official Journal of the European Union

L 328/21

DECISION OF THE EEA JOINT COMMITTEE

No 81/2007

of 6 July 2007

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area, as amended by the Protocol adjusting the
Agreement on the European Economic Area, hereinafter referred to as ‘the Agreement’, and in particular
Article 98 thereof,

Whereas:

(1) Annex II to the Agreement was amended by Decision of the EEA Joint Committee No 12/2007 of

27 April 2007 (1).

(2) Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the
European Parliament and of the Council as regards certain technical requirements for the donation,
procurement and testing of human tissues and cells (2) is to be incorporated into the Agreement.

(3) Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the
European Parliament and of the Council as regards traceability requirements, notification of serious
adverse reactions and events and certain technical requirements for the coding, processing, preservation,
storage and distribution of human tissues and cells (3) is to be incorporated into the Agreement,

HAS DECIDED AS FOLLOWS:

Article 1

The following points shall be inserted after point 15x (Regulation (EC) No 273/2004 of the European
Parliament and of the Council) of Chapter XIII of Annex II to the Agreement:

‘15y. 32006 L 0017: Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/
23/EC of the European Parliament and of the Council as regards certain technical requirements for the
donation, procurement and testing of human tissues and cells (OJ L 38, 9.2.2006, p. 40).

15z. 32006 L 0086: Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/
23/EC of the European Parliament and of the Council as regards traceability requirements, notification of
serious adverse reactions and events and certain technical requirements for the coding, processing,
preservation, storage and distribution of human tissues and cells (OJ L 294, 25.10.2006, p. 32).’

Article 2

The texts of Directives 2006/17/EC and 2006/86/EC in the Icelandic and Norwegian languages, to be
published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

(1) OJ L 209, 9.8.2007, p. 20.
(2) OJ L 38, 9.2.2006, p. 40.
(3) OJ L 294, 25.10.2006, p. 32.

L 328/22

EN

Official Journal of the European Union

13.12.2007

This Decision shall enter into force on 7 July 2007, provided that all the notifications under Article 103(1) of
the Agreement have been made to the EEA Joint Committee (*).

Article 3

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the
European Union.

Article 4

Done at Brussels, 6 July 2007.

For the EEA Joint Committee

The President

Stefán Haukur JÓHANNESSON

(*) No constitutional requirements indicated.