REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes
Date: 2017-11-23
Institutions: Directorate-General for Environment, European Commission
Subjects: animal experimentation, animal welfare, bio-ethics, delegated legislation, powers of the institutions (EU), protection of animals, scientific research, veterinary inspection, zootechnics

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   EUROPEAN COMMISSION  Brussels, 23.11.2017  COM(2017) 680 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes  
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND  
THE COUNCIL 

 on the exercise of the power to adopt delegated acts conferred on the Commission pursuant 
to Directive 2010/63/EU of the European Parliament and of the Council of 22 September 
2010 on the protection of animals used for scientific purposes 

1. INTRODUCTION  
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on 
the  protection  of  animals  used  for scientific  purposes1  regulates  the  care  and  use  of  animals  for 
scientific purposes. It lays down rules on the replacement and reduction of the use of animals in 
procedures  and  the  refinement  of  the  breeding,  accommodation,  care  and  use  of  animals  in 
procedures;  the  origin,  breeding,  marking,  care  and  accommodation,  and  killing  of  animals;  the 
operations and authorisation of breeders, suppliers and users; and the evaluation and authorisation 
of projects involving the use of live animals in procedures. 

This Directive empowers the Commission to adopt delegated acts to adapt the Annexes I and III 
to VIII (with the exception of provisions of Sections I and II of Annex VIII) to scientific and 
technical progress: 

  ANNEX I: List of animals referred to in Article 10 [requiring these specifically bred for 

use in procedures] 

  ANNEX III: Requirements for establishments and for the care and accommodation of 

animals 

  ANNEX IV: Methods of killing animals 
  ANNEX V: List of elements referred to in Article 23(3) [as the basis for Member States to 

establish minimum requirements for education and training of staff ] 

  ANNEX VI: List of elements referred to in Article 37(1)(c) [on obligatory information to 

be included in a project application] 

  ANNEX VII: Duties and tasks of the Union Reference Laboratory [established for the co-

ordination of validation of alternative methods at Union level] 

  ANNEX VIII: Severity classification of procedures [examples of different types of 

procedures assigned to each of the severity categories ]  

2. LEGAL BASIS  
This  report  is  required  under  Article  51(1)  of Directive  2010/63/EU.  Pursuant  to  this  provision, 
the  power  to  adopt  delegated  acts  was  conferred  on  the  Commission  for  a  period  of  8  years 
beginning on 9 November 2010 and the Commission is required to prepare a report in respect of 
the  delegation  of  power,  at  the  latest  12  months  before  the  end  of  the  eight-year  period.  The 
delegation  of  power  shall  be  automatically  extended  for  periods  of  an  identical  duration,  unless 
the European Parliament or the Council revokes it in accordance with Article 52.  

3. EXERCISE OF THE DELEGATION  
The exercise of the empowerment was deemed necessary for adapting several provisions foreseen 
by the Directive to scientific and technical progress. Until today, however, no sufficient scientific 
information  has  become  available  to  warrant  such  an  update  of  the  relevant  Annexes.  

1 OJ L276, 20.10.2010, p.33-79 

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In addition, the Directive took longer than was foreseen until its transposition in all Member State 
legislation was completed (the last of which was completed only in 2015) Therefore, there is at 
present only limited experience on the provisions contained in the Annexes of the Directive.  

However, as more experience is gained with the application of the Directive in practice, including 
Member State reports on exemptions granted to elements in some of the Annexes on the basis of 
new scientific evidence, as research continues to deliver new knowledge on the welfare needs of 
the  species  used,  and  as  new  investigation  techniques  and  tools  become  available,  the 
Commission  will  be  required  to  use  its  delegated  powers  to  ensure  the  Directive  is  adapted  to 
scientific and technical progress. 

4. CONCLUSION  
The Commission has, over the past seven years, not exercised the delegated powers conferred to it 
under Directive 2010/63/EU. It invites the European Parliament and the Council to take note of 
this report. 

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