Proposal for a COUNCIL DECISION on the position to be taken by the European Union in the EEA Joint Committeeconcerning an amendment to Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement.
Date: 2012-03-09
Institutions: European Commission
Subjects: European Economic Area, animal product, food safety, foodstuff, revision of an agreement, veterinary drug

EUROPEAN COMMISSION 

Brussels, 9.3.2012  
COM(2012) 98 final 

2012/0044 (NLE) 

Proposal for a 

COUNCIL DECISION 

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. 

 
 
  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

In  order  to  ensure  the  requisite  legal  security  and  homogeneity  of  the  Internal  Market,  the 
EEA  Joint  Committee  is  to  integrate  all  the  relevant  Union  legislation  into  the  EEA 
Agreement as soon as possible after its adoption. 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENTS 

The draft Decision of the EEA Joint Committee (annexed to the proposed Council Decision) 
aims  to  amend  Annex  II  (Technical  regulations,  standards,  testing  and  certification)  to  the 
EEA Agreement by adding new Union acquis in this field. This concerns Regulation (EC) No 
470/2009  of  the  European  Parliament  and  of  the  Council  of  6  May  2009  laying  down 
Community  procedures  for  the  establishment  of  residue  limits  of  pharmacologically  active 
substances  in  foodstuffs  of  animal  origin,  repealing  Council  Regulation  (EEC)  No  2377/90 
and  amending  Directive  2001/82/EC  of  the  European  Parliament  and  of  the  Council  and 
Regulation (EC) No 726/2004 of the European Parliament and of the Council, which is to be 
incorporated  into  the  Agreement.  Regulation  470/2009  provides  the  possibility  for  the 
Commission and Member States to request opinions from European Medicines Agency. In the 
present draft EEA Joint Committee Decisions it is proposed that the EEA EFTA States may 
request  such  opinions,  but  that  these  requests  shall  first  be  addressed  to  the  Commission 
which  shall,  where  it  considers  that  the  request  is  of  common  interest,  forward  it  to  the 
Agency for further processing 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

Article  1(3)  of  Council  Regulation  (EC)  No  2894/94  concerning  arrangements  for 
implementing  the  EEA  Agreement  provides  that  the  Council  establishes  the  position  to  be 
adopted on the Union’s behalf on such Decisions, on a proposal from the Commission. 

The Commission submits the Draft Decision of the EEA Joint Committee for adoption by the 
Council as the Union’s position. The Commission would hope to be able to present it in the 
EEA Joint Committee at the earliest possible opportunity. 

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2012/0044 (NLE) 

Proposal for a 

COUNCIL DECISION 

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. 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Articles 43, 168(4)(b) and 218 (9) thereof, 

Having regard to the proposal from the European Commission, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

Annex II to the Agreement on the European Economic Area, ("the EEA Agreement") 
contains  specific  provisions  and  arrangements  concerning  technical  regulations, 
standards, testing and certification. 

Regulation  (EC)  No  470/2009  of  the  European  Parliament  and  of  the  Council  of  6 
May 2009 laying down Community procedures for the establishment of residue limits 
of  pharmacologically  active  substances  in  foodstuffs  of  animal  origin,1  should  be 
incorporated  in  the  EEA  Agreement.  Regulation  (EC)  No  470/2009  repeals  Council 
Regulation  (EEC)  No  2377/90  and  amends  Directive  2001/82/EC  of  the  European 
Parliament  and  of  the  Council  and  Regulation  (EC)  No  726/2004  of  the  European 
Parliament  and  of  the  Council.  Commission  Regulation  (EU)  No  37/2010  of  22 
December  2009  on  pharmacologically  active  substances  and  their  classification 
regarding maximum residue limits in foodstuffs of animal origin2, as corrected by OJ 
L 293, 11.11.2010, p. 72, is to be incorporated into the Agreement, 

Annex II to the EEA Agreement should therefore be amended accordingly. 

The  position  of  the  Union  within  the  EEA  Joint  Committee  should  be  based  on  the 
attached draft Decision, 

1 
2 

OJ L 152, 16.6.2009, p. 11 
OJ L 15, 20.1.2010, p. 1. 

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HAS ADOPTED THIS DECISION:  

Article 1 

The  position  to  be  taken  by  the  Union  within  the  EEA  Joint  Committee  on  the  proposed 
amendment  to  Annex  II  to  the  EEA  Agreement  shall  be  based  on  the  draft  Decision  of  the 
EEA Joint Committee attached to this Decision. 

Article 2 

This Decision shall enter into force on the day of its adoption. 

Done at Brussels, 9.3.2012 

For the Council 
The President 

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ANNEX  

Draft 

DECISION OF THE EEA JOINT COMMITTEE  
No 

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

of  

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) 

(2) 

(3) 

Annex II to the Agreement was amended by Decision of the EEA Joint Committee 
No ... of …1. 

Regulation  (EC)  No  470/2009  of  the  European  Parliament  and  of  the  Council  of  6 
May  2009  laying  down  Community  procedures  for  the  establishment  of  residue 
limits  of  pharmacologically  active  substances  in  foodstuffs  of  animal  origin, 
repealing  Council  Regulation  (EEC)  No  2377/90  and  amending  Directive 
2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 
726/2004 of the European Parliament and of the Council2 is to be incorporated into 
the Agreement. 

Commission  Regulation 
(EU)  No  37/2010  of  22  December  2009  on 
pharmacologically  active  substances  and  their  classification  regarding  maximum 
residue limits in foodstuffs of animal origin3, as corrected by OJ L 293, 11.11.2010, 
p. 72, is to be incorporated into the Agreement, 

HAS ADOPTED THIS DECISION: 

Article 1 

Chapter XIII of Annex II to the Agreement shall be amended as follows: 

1. 

The following text shall be inserted in point 12 (deleted): 

‘32009 R 0470: Regulation (EC) No 470/2009 of the European Parliament and of the 
Council of 6 May 2009 laying down Community procedures for the establishment of 

1 
2 
3 

OJ L …  
OJ L 152, 16.6.2009, p. 11. 
OJ L 15, 20.1.2010, p. 1. 

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residue limits of pharmacologically active substances in foodstuffs of animal origin, 
repealing  Council  Regulation  (EEC)  No  2377/90  and  amending  Directive 
2001/82/EC of the European 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). 

The provisions of the Regulation shall, for the purposes of this Agreement, be read 
with the following adaptation: 

(a)  References  to  other  acts  in  the  Regulation  shall  be  considered  relevant  to  the 
extent and in the form that those acts are incorporated into the Agreement. 

(b)  An  EFTA  State  may  request  the  Agency  to  issue  an  opinion  according  to 
Article 9(1), first paragraph of Article 11, Article 15(1) and Article 27(2). Such 
a request shall, in the first place, be addressed to the Commission which shall, 
where  it  considers  that  the  request  is  of  common  interest,  forward  it  to  the 
Agency for further processing.’ 

2. 

The following text shall be inserted in point 13 (deleted): 

‘32010 R 0037: Commission Regulation (EU) No 37/2010 of 22 December 2009 on 
pharmacologically  active  substances  and  their  classification  regarding  maximum 
residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1), as corrected 
by OJ L 293, 11.11.2010, p. 72.’ 

3. 

The  following  indent  shall  be  added  in  points  15p  (Directive  2001/82/EC  of  the 
European Parliament and of the Council) and 15zb (Regulation (EC) No 726/2004 of 
the European Parliament and of the Council): 

‘- 

32009 R 0470: Regulation (EC) No 470/2009 of the European Parliament and 
of the Council of 6 May 2009 (OJ L 152, 16.6.2009, p. 11).’ 

Article 2 

The  texts  of  Regulations  (EC)  No  470/2009  and  37/2010,  as  corrected  by  OJ  L  293, 
11.11.2010,  p.  72,  in  the  Icelandic  and  Norwegian  languages,  to  be  published  in  the  EEA 
Supplement to the Official Journal of the European Union, shall be authentic. 

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

Article 3 

∗ 

[No constitutional requirements indicated.] [Constitutional requirements indicated.] 

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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, . 

For the EEA Joint Committee 

The President 

The Secretaries 
to the EEA Joint Committee 

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