Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 999/2001 as regards the implementing powers conferred on the Commission
Date: 2008-02-06
Institutions: European Commission
Subjects: EU control, European Commission, animal disease, disease prevention, health control, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 6.2.2008 
COM(2008) 53 final 

2008/0030 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EC) No 999/2001 as regards the implementing powers conferred 
on the Commission 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

1.1  Reform of the comitology procedures 

Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the  procedures 
for  the  exercise  of  implementing  powers  conferred  on  the  Commission1  was 
amended by Council Decision 2006/512/EC of 17 July 20062. 

Article 5a of the amended Decision 1999/468/EC introduced a new regulatory 
procedure  with  scrutiny  for  measures  of  general  scope  designed  to  amend 
non-essential  elements  of  a  basic  instrument  adopted  in  accordance  with  the 
procedure referred to in Article 251 of the Treaty, including by deleting some 
of  those elements  or  by supplementing  the instrument by  the  addition  of  new 
non-essential elements. 

1.2.  Priority alignment and general alignment 

In a joint statement3, the Parliament, the Council and the Commission listed a 
number of basic instruments that should be adapted to the amended Decision as 
a matter of urgency in order to incorporate the new regulatory procedure with 
scrutiny (priority alignment). For the regulatory procedure with scrutiny to be 
applicable to the other instruments adopted under the codecision procedure and 
already in force at the time when Decision 2006/512/EC took effect, the joint 
statement also calls for the adaptation of these instruments, in accordance with 
the applicable procedures (general alignment).  

The Commission has undertaken to examine all these instruments, with a view 
to  submitting,  by  the  end  of  2007,  legislative  proposals  to  adapt  them,  if 
necessary, to the new regulatory procedure with scrutiny4. 

1.3.  Method 

As mentioned in the Commission's Communication to the European Parliament 
and  the  Council  of  (…),  the  Commission  has  carefully  examined  all  the 
instruments adopted by codecision in order to identify those which permit the 
Commission  to  adopt  measures  of  general  scope  designed  to  amend 
non-essential  elements  of  the  basic  instrument  in  question.  The  Commission 
has identified more than 200 instruments that should be adapted.  

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OJ L 184, 17.7.1999, p. 23.  
OJ L 200, 22.7.2006, p. 11. 
OJ C 255, 21.10.2006, p. 1. 
PE 376.314v01-00 – A6-0236/2006 (Commission declaration annexed to the Parliament’s report) 

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Some  of  these  instruments  come  under  the  Commission's  codification 
programme. This is the case for Regulation (EC) No 999/2001 of the European 
Parliament and of the Council laying down rules for the prevention, control and 
eradication  of  certain  transmissible  spongiform  encephalopathies.  Adaptation 
to the new procedure should take place, depending on how far the codification 
process  has  progressed,  either  by  recasting  the  codified  proposal  or,  as  in  the 
present case, by legislative amendment. 

2. 

LEGAL ASPECTS OF THE PROPOSAL 

The purpose of adaptation is to incorporate the regulatory procedure with scrutiny, as 
provided for in Article 5a of amended Decision 1999/468/EC.  

Regulation  (EC)  No  999/2001  of  the  European  Parliament  and  of  the  Council  of 
22 May 2001 laying down rules for the prevention, control and eradication of certain 
transmissible  spongiform  encephalopathies  is  intended  to  provide  a  single  legal 
framework for transmissible spongiform encephalopathies (TSEs) in the Community. 

Regulation  (EC)  No  1923/2006  of  the  European  Parliament  and  of  the  Council 
amending  Regulation  (EC)  No  999/2001  introduced  the  regulatory  procedure  with 
scrutiny  only  for  certain  implementing  measures  which  were  concerned  by  the 
amendments.  Therefore,  Regulation  (EC)  No  999/2001  should  be  adapted  for  the 
remaining implementing powers.  

Since  the  basic  instrument  is  a  Regulation,  it  must  be  adapted  by  means  of  an 
equivalent instrument.  

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2008/0030 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EC) No 999/2001 as regards the implementing powers conferred 
on the Commission 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 152(4)(b) thereof, 

Having regard to the proposal from the Commission5, 

Having regard to the opinion of the European Economic and Social Committee6, 

Having consulted the Committee of the Regions7, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty8, 

Whereas: 

(1) 

(2) 

(3) 

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Regulation  (EC)  No  999/2001  of  the  European  Parliament  and  of  the  Council  of 
22 May 2001 laying down rules for the prevention, control and eradication of certain 
transmissible  spongiform  encephalopathies9  provides  that  certain  measures  are  to  be 
adopted  in  accordance  with  Council  Decision  1999/468/EC  of  28  June  1999  laying 
down  the  procedures  for  the  exercise  of  implementing  powers  conferred  on  the 
Commission. 

Decision 1999/468/EC has been amended by Decision 2006/512/EC, which introduced 
a regulatory procedure with scrutiny for measures of general scope designed to amend 
non-essential elements of a basic instrument adopted in accordance with the procedure 
referred to in Article 251 of the Treaty, including by deleting some of those elements 
or by supplementing the instrument by the addition of new non-essential elements. 

In accordance with the joint statement of the European Parliament, the Council and the 
Commission  on  Decision  2006/512/EC,  for  this  new  procedure  to  be  applicable  to 
instruments adopted in accordance with the procedure laid down in Article 251 of the 

OJ C xxx, xx.xx.xxxx, p. xx. 
OJ C xxx, xx.xx.xxxx, p. xx. 
OJ C xxx, xx.xx.xxxx, p. xx. 
OJ C , , p. . 
OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 727/2007 
(OJ L 165, 27.6.2007, p. 8). 

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(4) 

(5) 

(6) 

Treaty  which  are  already  in  force,  those  instruments  must  be  adjusted  in  accordance 
with the applicable procedures.  

As  regards  Regulation  (EC)  No  999/2001,  Regulation  (EC)  No  1923/2006  of  the 
European  Parliament  and  of  the  Council  introduced  the  regulatory  procedure  with 
scrutiny  only  for  certain  implementing  measures  which  were  concerned  by  the 
amendments.  Therefore,  Regulation  (EC)  No  999/2001  should  be  adapted  for  the 
remaining implementing powers. 

Power should be conferred on the Commission in particular for the approval of rapid 
tests,  the  extension  of  certain  provisions  to  other  products  of  animal  origin,  the 
adoption  of  implementing  rules  including  the  method  to  confirm  BSE  in  ovine  and 
caprine  animals,  the  modification  of  the  Annexes  and  the  adoption  of  transitional 
measures.  

Since  these  measures  are  of  general  scope  and  are  designed  to  amend  non-essential 
elements of Regulation (EC) No 999/2001, they must be adopted in accordance with 
the  regulatory  procedure  with  scrutiny  provided  for  in  Article  5a  of  Decision 
1999/468/EC. 

(7) 

Regulation (EC) No 999/2001 should be amended accordingly, 

HAVE ADOPTED THIS REGULATION: 

Article 1 

Regulation (EC) No 999/2001 is hereby amended as follows: 

(1) 

Article 5, paragraph 3, third subparagraph is amended as follows: 

" 

The  rapid  tests  shall  be  approved  for  that  purpose  in  accordance  with  the 
procedure referred to in Article 24(3) and entered on a list set out in Annex X, 
Chapter C, point 4."  

(2) 

Article 16, paragraph 7 is amended as follows: 

"7. 

In accordance with the procedure referred to in Article 24(3), the provisions of 
paragraphs 1 to 6 may be extended to other products of animal origin. Rules for 
the  implementation  of  this  Article  shall  be  adopted  in  accordance  with  the 
procedure referred to in Article 24(2)." 

(3) 

Article 20, paragraph 2 is amended as follows: 

"2.  Where  necessary 

to  ensure 

this  Article, 
implementing rules, including the method to confirm BSE in ovine and caprine 
animals,  shall  be  adopted  in  accordance  with  the  procedure  referred  to  in 
Article 24(3)." 

the  uniform  application  of 

(4) 

The first paragraph of Article 23 is amended as follows:  

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"After  consultation  of  the  appropriate  scientific  committee  on  any  question  which 
could  have  an  impact  on  public  health,  the  annexes  shall  be  amended  or 
supplemented  and  any  appropriate  transitional  measures  shall  be  adopted  in 
accordance with the procedure referred to in Article 24(3)." 

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(5) 

Article 23a is amended as follows: 

(a)  Point (a) is replaced by the following: 

"(a)  approval of the rapid tests referred to in Article 5(3) third subparagraph, 

Article 6(1) and Article 8(2)," 

(b)  The following points are added:  

"(k)  extension  to  other  products  of  animal  origin  of  the  provisions  of 

paragraphs 1 to 6 of Article 16, 

(l) 

adoption of implementing rules referred to in Article 20(2), including the 
method to confirm BSE in ovine and caprine animals, 

(m)  amendment  or  addition  to  the  annexes  and  adoption  of  any  appropriate 

transitional measures referred to in Article 23." 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 2 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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