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28.4.2012 Official
Journal
of
the
European
Union L
116/7
COUNCIL DECISION
of 24 April 2012
on the position to be taken by the European Union in the EEA Joint Committee concerning an
amendment to Annex II (Technical regulations, standards, testing and certification) to the EEA
Agreement
(2012/229/EU)
THE COUNCIL OF THE EUROPEAN UNION,
substances and their classification regarding maximum
residue limits in foodstuffs of animal origin ( 7 ), as
Having regard to the Treaty on the Functioning of the European
corrected in OJ L 293, 11.11.2010, p. 72, should also
Union, and in particular Article 43, Article 168(4)(b) and
be incorporated into the EEA Agreement.
Article 218(9) thereof,
(3) Annex
II
to
the
EEA
Agreement
should
therefore
be
Having regard to Council Regulation (EC) No 2894/94 of
amended accordingly.
28 November 1994 concerning arrangements for implementing
the Agreement on the European Economic Area ( 1 ), and in
(4) The
position
of
the
Union
in
the
EEA
Joint
Committee
particular Article 1(3) thereof,
should therefore be based on the attached draft Decision,
Having regard to the proposal from the European Commission,
HAS ADOPTED THIS DECISION:
Whereas:
Article 1
The position to be taken by the European Union in the EEA
(1) Annex
II
to
the
Agreement
on
the
European
Economic
Area (
Joint Committee on the proposed amendment to Annex II

2 ) (‘the EEA Agreement’) contains specific
provisions and arrangements concerning technical regu
(Technical regulations, standards, testing and certification) to
lations, standards, testing and certification.
the EEA Agreement shall be based on the draft Decision of

the EEA Joint Committee attached to this Decision.
(2) Regulation
(EC)
No
470/2009
of
the
European
Parliament and of the Council of 6 May 2009 laying
Article 2
down Community procedures for the establishment of
This Decision shall enter into force on the day of its adoption.
residue limits of pharmacologically active substances in
foodstuffs of animal origin ( 3 ) should be incorporated
into the EEA Agreement. Regulation (EC) No 470/2009
repealed Council Regulation (EEC) No 2377/90 (
Done at Luxembourg, 24 April 2012.

4 ) and
amended Directive 2001/82/EC of the European
Parliament and of the Council ( 5 ) and Regulation (EC)
For the Council
No 726/2004 of the European Parliament and of the
Council (
The President

6 ). Commission Regulation (EU) No 37/2010
of 22 December 2009 on pharmacologically active
N. WAMMEN
( 1 ) OJ L 305, 30.11.1994, p. 6.
( 2 ) OJ L 1, 3.1.1994, p. 3.
( 3 ) OJ L 152, 16.6.2009, p. 11.
( 4 ) Regulation (EEC) No 2377/90 of 26 June 1990 laying down a
Community procedure for the establishment of maximum residue
limits of veterinary medicinal products in foodstuffs of animal origin
(OJ L 224, 18.8.1990, p. 1).
( 5 ) Directive 2001/82/EC of 6 November 2001 on the Community
code relating to veterinary medicinal products (OJ L 311,
28.11.2001, p. 1).
( 6 ) Regulation (EC) No 726/2004 of 31 March 2004 laying down
Community procedures for the authorisation and supervision of
medicinal products for human and veterinary use and establishing
a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
( 7 ) OJ L 15, 20.1.2010, p. 1.

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L 116/8
EN
Official Journal of the European Union
28.4.2012
DRAFT
DECISION No …/2012 OF THE EEA JOINT COMMITTEE
of
amending Annex II (Technical regulations, standards, testing and certification) to the EEA
Agreement
THE EEA JOINT COMMITTEE,
Parliament and of the Council and Regulation (EC) No
726/2004 of the European Parliament and of the
Council (OJ L 152, 16.6.2009, p. 11).
Having regard to the Agreement on the European Economic
Area, as amended by the Protocol adjusting the Agreement
on the European Economic Area (‘the EEA Agreement’), and
The provisions of the Regulation shall, for the purposes of
in particular Article 98 thereof,
this Agreement, be read with the following adaptation:
Whereas:
(a) References to other acts in the Regulation shall be
considered relevant to the extent and in the form that
(1) Regulation
(EC)
No
470/2009
of
the
European
those acts are incorporated into the Agreement.
Parliament and of the Council of 6 May 2009 laying
down Community procedures for the establishment of
residue limits of pharmacologically active substances in
(b) An EFTA State may request the Agency to issue an
foodstuffs of animal origin, repealing Council Regulation
opinion according to Article 9(1), first paragraph of
(EEC) No 2377/90 and amending Directive 2001/82/EC
Article 11, Article 15(1) and Article 27(2). Such a
of the European Parliament and of the Council and Regu
request shall, in the first place, be addressed to the
lation (EC) No 726/2004 of the European Parliament and
Commission which shall, where it considers that the
of the Council ( 1 ) is to be incorporated into the EEA
request is of common interest, forward it to the
Agreement.
Agency for further processing.’;
(2) Commission Regulation (EU) No 37/2010 of (2) point 13 is replaced by the following:
22 December 2009 on pharmacologically active
substances and their classification regarding maximum
residue limits in foodstuffs of animal origin ( 2 ), as
corrected in OJ L 293, 11.11.2010, p. 72, is to be
‘13. 32010 R 0037: Commission Regulation (EU) No
incorporated into the EEA Agreement.
37/2010 of 22 December 2009 on pharmacologically
active substances and their classification regarding
maximum residue limits in foodstuffs of animal
(3) Annex
II
to
the
EEA
Agreement
should
therefore
be
origin (OJ L 15, 20.1.2010, p. 1), as corrected in OJ
amended accordingly,
L 293, 11.11.2010, p. 72.’;
HAS ADOPTED THIS DECISION:
(3) the text of point 14 (Council Regulation (EEC) No 2377/90)
is deleted;
Article 1
Chapter XIII of Annex II (Technical regulations, standards,
(4) the following indent is added in points 15p (Directive
testing and certification) to the EEA Agreement shall be
2001/82/EC of the European Parliament and of the
amended as follows:
Council) and 15zb (Regulation (EC) No 726/2004 of the
European Parliament and of the Council):
(1) point 12 is replaced by the following:
‘— 32009 R 0470: Regulation (EC) No 470/2009 of the
European Parliament and of the Council of 6 May
‘12. 32009 R 0470: Regulation (EC) No 470/2009 of the
2009 (OJ L 152, 16.6.2009, p. 11).’.
European Parliament and of the Council of 6 May
2009 laying down Community procedures for the
establishment of residue limits of pharmacologically
Article 2
active substances in foodstuffs of animal origin,
repealing Council Regulation (EEC) No 2377/90 and
The texts of Regulation (EC) No 470/2009 and of Regulation
amending Directive 2001/82/EC of the European
(EU) No 37/2010, as corrected in OJ L 293, 11.11.2010, p. 72,
in the Icelandic and Norwegian languages, to be published in
( 1 ) OJ L 152, 16.6.2009, p. 11.
the EEA Supplement to the Official Journal of the European Union,
( 2 ) OJ L 15, 20.1.2010, p. 1.
shall be authentic.

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EN
28.4.2012 Official
Journal
of
the
European
Union L
116/9
Article 3
This Decision shall enter into force on …, provided that all the notifications under Article 103(1) of the
EEA Agreement have been made to the EEA Joint Committee (*).
Article 4
This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of
the European Union.
Done at …, …
For the EEA Joint Committee
The Secretaries
The President
to the EEA Joint Committee
(*) [No constitutional requirements indicated.] [Constitutional requirements indicated.]

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Document Outline

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