COMMISSION STAFF WORKING DOCUMENT Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes in the Member States of the European Union
Date: 2020-02-05
Institutions: Directorate-General for Environment, European Commission
Subjects: EU Member State, animal experimentation, animal welfare, application of EU law, bio-ethics, protection of animals, scientific research, veterinary inspection

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 5.2.2020  SWD(2020) 15 final  COMMISSION STAFF WORKING DOCUMENT              Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL  on the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes in the Member States of the European Union           {COM(2020) 15 final}  
 
 
CONTENTS 

Introduction ............................................................................................................................................ 3 

i. Information from the Member States .................................................................................................... 3 

ii. Structure of the Report.......................................................................................................................... 4 

A. GENERAL INFORMATION .................................................................................................................... 4 

B. STRUCTURES AND FRAMEWORK ........................................................................................................ 5 

B.1. Competent authorities (Article 59 of Directive 2010/63/EU) ............................................................ 5 

B.2. National committee (Article 49 of Directive 2010/63/EU) .............................................................. 11 

B.3. Education and training of personnel (Article 23 of Directive 2010/63/EU) ..................................... 14 

B.4. Project evaluation and authorisation (Articles 38 and 40 of Directive 2010/63/EU) ...................... 20 

C. OPERATION ....................................................................................................................................... 28 

C.1. Projects ............................................................................................................................................. 28 

C.1.i. Granting of project authorisation (Articles 40 and 41 of Directive 2010/63/EU) ...................... 28 

C.1.ii. Retrospective assessment, non-technical project summaries (Articles 38, 39 and 43 of 
Directive 2010/63/EU) ......................................................................................................................... 32 

C.2. Animals bred for use in procedures (Articles 10, 28 and 30) ........................................................... 37 

C.2.i. Animal bred, killed and not used in procedures ........................................................................ 37 

C.2.ii. Sourcing of non-human primates .............................................................................................. 42 

C.3. Exemptions ....................................................................................................................................... 43 

C.4. Animal Welfare Body (Articles 26 and 27 of Directive 2010/63/EU) ............................................... 46 

D. PRINCIPLES OF REPLACEMENT, REDUCTION AND REFINEMENT ..................................................... 50 

D.1. Principle of replacement, reduction and refinement (Articles 4 and 13 of Directive 2010/63/EU) 50 

D.2. Avoidance of duplication (Article 46 of Directive 2010/63/EU) ...................................................... 53 

D.3. Tissue sampling of genetically altered animals (Articles 4, 30 and 38 of Directive 2010/63/EU .... 54 

E. ENFORCEMENT ................................................................................................................................. 57 

E.1. Authorisation of breeders, suppliers and users (Articles 20 and 21 of Directive 2010/63/EU) ....... 57 

E.2. Inspections (Article 34 of Directive 2010/63/EU) ............................................................................. 62 

E.3. Withdrawals of project authorisation (Article 44 of Directive 2010/63/EU) ................................... 66 

E.4. Penalties (Article 60 of Directive 2010/63/EU) ................................................................................ 67 

F. OTHER – ADDITIONAL VOLUNTARY QUESTIONS .............................................................................. 69 

F.1. Problematic areas for implementation of the Directive .................................................................. 69 

F.2. Views on well-functioning elements of the Directive in your Member State .................................. 70 

F.3. Views on issues that would benefit from collaborative efforts to improve implementation of the 
Directive .................................................................................................................................................. 70 

F.4. Any other additional comments concerning the implementation of the Directive  ........................ 71 

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G. Commission activities to facilitate the imlementation of the Directive .......................................... 71 

G.1. Transposition conformity checks ..................................................................................................... 71 

G.2. Other activities to facilitate correct and uniform implementation of the Directive. ...................... 71 

2 

 
 
 
 
 
INTRODUCTION 
This Staff Working Document is an annex to the main report1 to the European Parliament and the 
Council on Member States’ implementation of Directive 2010/63/EU on the protection of animals 
used for scientific purposes2 (“the Directive”).   

Under Article 54(1), Member States are required to send the information on the implementation 
of the Directive and in particular Articles 10(1), 26, 28, 34, 38, 39, 43 and 46 to the Commission. 
The  detailed  content  of  Member  State  reporting  requirements  is  laid  out  in  Annex  I  of 
Commission Implementing Decision 2012/707/EU3 (“the Annex”).  

In June 2019, the Directive was amended by Regulation (EU) 2019/10104 (“the Regulation”). In 
particular, Article 54(1) was amended to require the next Member State implementation reports to 
be  submitted  to  the  Commission  through  electronic  transfer  by  10  November  2023,  and  every 
five  years  thereafter.  Furthermore,  the  obligation  for  the  Commission  to  submit  a  report  on  its 
implementation  to  the  European  Parliament  and  the  Council  by  10  November  2019  (Article 
57(1)) was deleted. 

As  the  Regulation  was  adopted  after  Member  States  had  already  submitted  the  information 
covering  the  first  five  years  of  the  functioning  of  the  Directive,  i.e.  the  period  2013-2017,  the 
European  Commission  considers  it  appropriate,  especially  given  that  improved  transparency  is 
one  of  the  key  objectives  of  the  Directive,  to  provide  a  consolidated  EU  report  on  its 
implementation.    

This Commission Staff Working Document presents the results of the examination of the reports 
by  the  Member  States  in  greater  detail  than  in  the  report  to  the  European  institutions,  which 
focuses on the main elements. It describes how Member States have implemented the Directive, 
in  line  with  the  requirements  of  the  Annex,  and  highlights  any  identified  issues.  It  does  not 
provide an exhaustive account of all national implementation measures.  

i. Information from the Member States 

Member  States  were  requested  to  submit  their  national  implementation  reports  using  a  tailored 
questionnaire.  The  deadline  for  the  submission  was  10  November  2018  in  accordance  with 
Article  54(1),  as  applicable  at  the  relevant  time.  The  questionnaire  covered  all  the  elements 
described  in  the  Annex  to  Commission  Implementing  Decision  2012/707/EU.  Furthermore,  it 
contained  some  additional,  voluntary,  questions  (marked  with  an  asterisk)  to  provide  wider 
context  to the answers.  In some cases, an element  described in  the Annex was broken down to 
sub-questions to aid comprehension of the reporting obligation. 

22  Member  States  submitted  their  reports  by  the  deadline.  Of  the  six  Member  States  that  were 
late, the last submitted the report at the end of February 2019. When reviewing the content and 
the  quality  of  the  provided  information,  on  the  one  hand  several  shortfalls  were  identified 
including  unanswered  compulsory  questions,  incorrect  data  due  to  misunderstanding  of  the 
reporting obligation, or the report containing conflicting information. On the other, some Member 
State reports gave very detailed information and often provided additional, voluntary information, 

1 COM(2020)15 final 
2 OJ L 276, 20.10.2010, p. 33–79 
3 OJ L 320, 17.11.2012, p. 33–50 
4 OJ L 170, 25.6.2019, p. 115–127 

3 

 
 
                                                           
to  aid  understanding.  Concerning  the  shortfalls,  in  some  cases  further  clarity  was  obtained 
through  bilateral  communication,  but  in  a  number  of  cases  it  was  not  possible  due  to  the  tight 
deadline  set  for  the  publication  of  the  EU  report.  The  conclusions  and  tables  included  in  this 
report are based on the original submissions and incorporate directly any later updates/corrections 
to  these.  The  last  Member  State  correction  to  the  original  submission  was  received  as  late  as 
September 2019. Member State submissions can be found at  
https://ec.europa.eu/environment/chemicals/lab_animals/index_en.htm.  

The inconsistent quality of reporting has made drawing of conclusions at EU level challenging. 
Some such areas will be highlighted in the report. 

ii. Structure of the Report 

The structure of the report will follow the format and order as set out in the Annex. In addition, to 
the legal reporting obligations, the questions from the questionnaire precede the analysis. In some 
cases,  survey  questions  are  grouped  together  when  these  are  closely  linked  and  would  have 
otherwise resulted in repeated answers. Some comparative tables are presented but only drawing 
from  elements  that  make  part  of  compulsory  Annex  I  reporting  obligations,  and  for  which  the 
basis of the reporting is assumed to be similar.  

A. GENERAL INFORMATION 

Reporting obligation  

“Changes  made  to  national  measures  regarding  the  implementation  of  Directive  2010/63/EU 
since the previous report” 

Analysis 

Question in the questionnaire  

A  -  1  Describe  main  changes  made  to  national  legislative  measures  regarding  the 
implementation  of  Directive  2010/63/EU.  For  the  purposes  of  the  first  implementation 
report, the changes should reflect those made to the previous legislation (under Directive 
86/609/EEC)  as  a  result  of  the  transposition  of  the  Directive,  and  any  subsequent 
amendments. "Description of main changes" should provide an understanding of the key 
elements that underwent legislative changes.  

Ten  Member  States  indicated  that  the  national  legislation  had  been  changed  to  meet  the 
provisions  of  the  new  Directive,  but  did  not  provide  any  information  on  what  changes  were 
required to the previous legislation. 

Of the remaining responses, some Member States reported major changes to their legislative 
structure,  for  example  with  the  introduction  for  the  first  time  of  project  evaluation  and 
authorisation  processes,  the  publication  of  non-technical  project  summaries  and  the 
requirement to have Animal Welfare Bodies in each establishment. 

Others  reported  fewer  changes,  for  example,  Member  States  where  project  authorisation 
systems  had  already  been  in  place  under  Directive  86/609/EEC.  However,  the  new 
requirements  for  severity  classification  and  reporting,  non-technical  project  summaries, 
retrospective  assessment  and  timeliness  of  authorisation  decisions  necessitated  changes  to 

4 

 
 
 
legislation  in  all  Member  States.  In  addition,  the  following  elements  were  reported  by  a 
majority of Member States as having resulted in significant changes: 

 
 
 

the extended scope to include foetal forms of mammals and also Cephalopods; 
the new requirements for accommodation and care and methods of killing; 
the risk-based approach to, and frequency of, inspections.  

The focus on alternatives has also required many Member States to consider how best to meet 
the provisions in the Directive. A number of Member States have developed voluntary Three 
Rs centres to promote improved availability of information and development of alternatives.   

National Committees were new to many Member States. 

In summary, from the responses received, there  were significant  differences among Member 
States on the extent of changes required to existing legislation to meet the requirements of the 
new Directive. 

B. STRUCTURES AND FRAMEWORK 

B.1. Competent authorities (Article 59 of Directive 2010/63/EU) 

Reporting obligation  

“information  on  the  framework  for  competent  authorities,  including  the  numbers  and  types  of 
authorities” 

Background 

The Directive requires that the following tasks are performed by a competent authority 

1)  Authorisation of breeders, suppliers and users (Article 20(1)) 
2)  Inspections (Article34(1)) 
3)  Project evaluation (Article 36(2)) 
4)  Project authorisation (Article 36(1)) 
5)  Retrospective assessment of projects (Article 39(1)) 

A  competent  authority  is  usually  a  public  authority.  However,  the  Directive  allows  also 
bodies  other  than  public  authorities  to  be  designated  as  competent  authorities  provided  the 
conditions in Article 59(1) are met, namely, that the body  

“(a) has the expertise and infrastructure required to carry out the tasks; and  

(b) is free of any conflict of interests as regards the performance of the tasks.”  

Finally,  in  reference  to  the  task  of  project  evaluation,  the  Directive  further  requires  in  its 
Article 38(3) and (4): 

“3.  The  competent  authority  carrying  out  the  project  evaluation  shall  consider 
expertise in particular in the following areas:  

(a)  the  areas  of  scientific  use  for  which  animals  will  be  used  including 
replacement, reduction and refinement in the respective areas;  

(b) experimental design, including statistics where appropriate;  

5 

 
 
(c)  veterinary  practice  in  laboratory  animal  science  or  wildlife  veterinary 
practice where appropriate;  

(d) animal husbandry and care, in relation to the species that are intended to 
be used.  

4. The project evaluation process shall be transparent.  

Subject to safeguarding intellectual property and confidential information, the project 
evaluation shall be performed in an impartial manner and may integrate the opinion 
of independent parties. “ 

Analysis 

Questions in the questionnaire 

2  -  Is  the  implementation  of  Directive  2010/63/EU  a  responsibility  of  one  or  more 

ministry/ministries 

2.bis - Please provide the name of the ministry 

2.tris  -  Please  provide  the  name  of  the  ministries  involved and  briefly  describe  the 

distribution of responsibilities 

B  -  1.1  Provide  information  on  the  framework  for  competent  authorities.  Where  there  is 
more  than  one  competent  authority,  explain  1)  how the  tasks  are  divided  between 
different  authorities  2) how the  authorities  interact  to  ensure  that  the  Directive  is 
implemented  effectively. If  possible,  please  explain  what  measures  are  in  place  to 
ensure coherent approach and consistency of outcomes. Make sure to consider all five 
tasks requiring a competent authority i.e. authorisation of establishments, inspections, 
project evaluation, project authorisation and retrospective assessment. 

* B - 1.1.bis An organogram or another explanatory document can be uploaded here. 

B  –  1.2  There  is  only  one public  competent  authority  for  the  Member  State,  or  for  each 
region (where regional structure) who is tasked with all five tasks requiring competent 
authority (I.e.,  the  same  competent  authority  (national/regional) performs  all  tasks: 
authorisation  of  establishments,  inspections,  project  evaluation,  project  authorisation 
and retrospective assessment of projects). Yes/No 

B - 1.2.bis If your MS has a regional structure, how many regional authorities are there? 

B - 1.3 Other than single national or regional authority: Please provide information on the 

numbers and types of authorities per task 

B  -  1.3.bis  Please  explain  if  "other"  than  national/regional  authority  and/or  "non-public 

authority" was selected 

Implementation of the Directive 

In  addition  to  requiring  information  on  competent  authorities  assigned  for  the  tasks  in  the 
Directive,  the  questionnaire  also  invited  Member  States  to  specify  the  ministry(/ies) 
responsible  for  the  implementation  of  the  Directive.  Where  the  responsibility  was  shared, 
further clarification was requested on the distribution of responsibilities.  

6 

 
 
Is the implementation of Directive 2010/63/EU a responsibility of one or more 
ministry/ministries? 

Responsibility of a single ministry 
Shared responsibility between two or more ministries 
Total 

21 
7 
28 

Most ministries responsible for the implementation of the Directive are those responsible for 
agriculture and the environment, although some are responsible for health, education, science 
and innovation.  

Competent authorities 

It  is  challenging  to  draw  EU  level  conclusions  on  the  way  in  which  tasks  are  assigned  to 
competent authorities. Member States have highly different structures varying from central to 
regional  and  local  structures.  In  addition,  in  some  cases  the  designation  of  tasks  between 
competent authorities may vary even between different regions within a single Member State. 
Member States have implemented the responsibilities for competent authorities in a number of 
different ways, to some extent reflecting the different national legislative frameworks and to 
some extent reflecting the numbers of animals used.  

The  analysis  is  further  complicated  by  the  fact  that  some  Member  States  may  seem  to  have 
misunderstood some of the questions, for example, reporting only one single public authority, 
however, having a regional structure with regional authorities.  

Finally, it is not certain that the term ‘competent authority’ is understood in the same manner 
by all Member States. On one hand, some Member States have stated that only one competent 
authority  is  responsible  for  five  tasks  in  the  Directive.  On  the  other,  in  written  comments, 
reference is made for example to project evaluation which is delegated to ‘ethics committees’. 

Is there only one public competent authority for the Member State? 

Yes 
No; there are two or more different types of competent authorities depending on the 
task 
Total 

15 
13 

28 

If your Member State has a regional structure, how many regional authorities are 
there? 

Latvia 
Luxembourg 
Austria 
United Kingdom 
Total 

1 
0 
10 
2 
13 

Of  the  15  Member  States  who  reported  having  one  public  competent  authority,  nine 
(Bulgaria,  Ireland,  Croatia,  Cyprus,  Latvia,  Lithuania,  Luxembourg,  Portugal  and  Slovakia) 
indicated  a  single  competent  authority  being  responsible  for  all  five  tasks,  namely 

7 

 
 
 
 
 
 
authorisation  of  establishments,  inspections,  project  evaluation,  project  authorisation  and 
retrospective assessment. 

Two Member States (Austria and United Kingdom) stated that there were regional competent 
authorities (ten and two regional authorities respectively) but that one competent authority in 
each region is responsible for all five tasks. 

Four Member States (Denmark, Italy, Romania and Slovenia) gave conflicting information: 

  Denmark – indicated one competent authority – but in another instance reported split 
responsibility  between  Danish  Experimentation  Council  and  Animal  Experiments 
Inspectorate; 
Italy  –  indicated  one  competent  authority  –  but  in  another  instance  reported  split 
responsibility  for  tasks  and  separate  competent  authorities  for  authorisation  and 
inspection of breeders, suppliers and users; 

 

  Romania - indicated one competent authority  - but in another instance stated that the 
evaluation of the projects is carried out by ethics committees established within the 
establishments of users; 

  Slovenia  – indicated one competent  authority  – but  in  another instance  reported ten 

regional offices; 

13  Member  States  (Belgium,  Czechia,  Germany,  Estonia,  Greece,  Spain,  France,  Hungary, 
Malta,  Netherlands,  Poland,  Finland  and  Sweden)  indicated  more  than  one  competent 
authority. 

8 

 
 
Other than single national or regional authority: Please provide information on the numbers and types of authorities per task. 

N = National; R = Regional; O = Other ; P = Public authority; NP = Non-public authority  

Member State 

Number of CA for 
authorisation of  
establishments 

Number of CA for 
inspections 

Number of CA for 
project evaluation 

Number of CA for 
project authorisation 

Number of CA for 
retrospective 
assessment of projects 

Belgium 

Czechia 

Germany 

Estonia 

Greece 

Spain 

France 

Hungary 

Malta 

Netherlands 

Poland 

Finland 

Sweden 

3 

1 

26 

11 

13 

17 

1 

1 

1 

305 

2 

R 

N 

R 

R 

R 

R 

N 

N 

N 

O 

R 

P 

P 

P 

P 

P 

P 

P 

P 

P 

P 

3 

14 

285 

11 

71 

17 

1 

19 

1 

1 

305 

2 

R 

R 

R 

R 

R 

R 

N 

R 

N 

N 

O 

R 

P 

P 

P 

P 

P 

P 

P 

P 

P 

P 

33 

8 

26 

1 

57 

89 

125 

1 

2 

17 

11 

1 

O 

O 

R 

N 

R 

N 

O 

N 

N 

R 

O 

N 

NP 

P 

P 

P 

P/NP 

NP 

P 

P 

NP 

P 

P 

33 

8 

26 

1 

13 

17 

1 

19 

2 

1 

11 

1 

O 

O 

R 

N 

R 

R 

N 

R 

N 

N 

O 

N 

NP 

P 

P 

P 

P 

P 

P 

P 

P 

P 

33 

8 

26 

1 

57 

89 

125 

1 

1 

1 

11 

1 

O 

O 

R 

N 

R 

N 

O 

N 

N 

N 

O 

N 

NP 

P 

P 

P 

P/NP 

NP 

P 

P 

P 

P 

1 

N 

P 

21 

R 

P 

6 

R 

P 

6 

R 

P 

1 

N 

P 

9 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A number of Member States have formal regional structures, for example Germany, Spain and 
Austria,  where  all  five  tasks  are  allocated  to  the  regional  governments  who  determine  the 
allocation of tasks within their respective region. 

In  many  Member  States,  the  tasks  are  allocated  to  two,  three  or  four  different  types  of 
competent authorities, responsible for different tasks in the Directive. 

Where  there  are  two  or  more  different  types  of  competent  authority  depending  on  the  task, 
numbers of these in five Member States suggest that there may be grouping of tasks such that 
authorisation  of  establishments  and  inspections  may  be  done  by  the  same  authority,  and 
project  authorisation  and  retrospective  assessment  by  a  separate  authority.  In  two  additional 
Member  States  the  same  authority  may  perform  project  evaluation  and  retrospective 
assessment. 

The  more  common  division  is  a  separation  of  inspection  and  authorisation  of  breeders, 
suppliers and users, from project evaluation and authorisation, and retrospective assessment. 

In some Member States, for example Hungary and Netherlands, a single competent authority 
is responsible for authorisation of breeders, suppliers and users and inspections, but separate 
competent  authority/(ies)  have  responsibility  for  project  evaluation  and  authorisation,  and 
retrospective assessment.  

In contrast, for example, in Poland, although the division of functions is similar, they reported 
305  competent  authorities  with  responsibility  for  inspection  and  authorisation  of  breeders, 
suppliers  and  users.  Inspection  is  often  undertaken  by  Veterinary  Authorities,  and  the 
competent authority role for this function is often undertaken at a local or regional level – for 
example Greece reported 71, Germany 285.  

The structures for  project  evaluation  and authorisation  also  differ significantly  –  from  single 
committees (competent authorities) charged with evaluation and authorisation for all projects 
in  the  Member  State,  to  regional  structures  (for  example  Germany  (26),  Austria  (10)  and 
Sweden  (6))  to  local  ethics  committees  which  evaluate  only  projects  local  to  that  area,  or 
within a single establishment (for example Belgium (33), France (125)). Authorisation may be 
performed by another competent authority. 

It has been acknowledged that the greater the number of competent authorities involved in the 
implementation  of  the  Directive  within  a  Member  State,  the  greater  the  challenges  are  to 
ensure a common and consistent approach and outcomes. 

Methods adopted to promote a consistent approach include training for project evaluators and 
inspectors,  regular  meetings  of  competent  authorities,  standardised  project  application  and 
evaluation forms, standard checklists for authorisation and inspection of establishments. 

The  2017  review  of  the  Directive5  identified  difficulties  for  the  scientific  community  due  to 
variations  in  implementation  within  and  between  Member  States.  Given  the  significant 
variations in competent authority structures across Member States it is perhaps not surprising 
that concerns over inconsistencies were raised.  

5 https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1510219889073&uri=COM:2017:631:FIN  

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Five  Member  States  submitted  an  organogram  or  another  explanatory  document  (Belgium, 
Germany,  Latvia,  Netherlands  and  Slovakia).  Three  of  these  gave  a  pictorial  representation, 
which  appear  to  correlate  with  elements  of  written  text.  These  are  included  in  the  detailed 
Member State summaries.  

B.2. National committee (Article 49 of Directive 2010/63/EU) 

Reporting obligation:  

“information on the structure and operation of the national committee” 

Background 

Article 49 

National committees for the protection of animals used for scientific purposes  

1. Each Member State shall establish a national committee for the protection of animals used 
for scientific purposes. It shall advise the competent authorities and animal-welfare bodies on 
matters  dealing  with  the  acquisition,  breeding,  accommodation,  care  and  use  of  animals  in 
procedures and ensure sharing of best practice.  

2.  The  national  committees  referred  to  in  paragraph  1  shall  exchange  information  on  the 
operation of animal-welfare bodies and project evaluation and share best practice within the 
Union. 

Analysis 

A  number  of  Member  States  already  had  in  place  similar  committees  advising  on  matters 
relating  to  the  use  of  animals  in  research,  whereas  for  others  this  was  a  new  requirement. 
Although many Member States had a committee in place soon after transposition, in others it 
took some years to develop the necessary framework, and therefore experience of the various 
National Committee functions are varied. 

The general view given is that as the role evolves, links between Animal Welfare Bodies and 
National  Committees  continue  to  strengthen,  but  their  effectiveness  is  almost  wholly 
dependent on suitable resourcing by the Member State.  

2.1.Structure 

Question in the questionnaire  

B - 2.1 Provide information on the structure of your National Committee 

National  Committees  vary  in  composition,  but  generally  include  members  of  differing 
scientific  and  welfare  backgrounds  and  disciplines,  with  logistical  support  provided  by  the 
ministry(/ies)/authorities  –  depending  on  Member  State  structure.  Some  members  are  also 
members of Animal Welfare Bodies. 

Membership  is  generally  for  a  limited  period,  and  appointments  are  endorsed  by 
ministry(/ies)/authorities. 

The frequency of meetings varies significantly, largely dependent on the size and complexity 
of  scientific  work  conducted,  and  whether  or  not  additional  responsibilities,  such  as  project 
evaluation, have been added to their remit.  Meetings reported vary from annual to monthly. 

11 

 
 
Financial support varies, and this is reflected in the level of activities achieved. 

A number of National Committees have bespoke web-sites6, and publish their activities. 

2.2.Advice to competent authorities, in particular with regard to project evaluation 

Question in the questionnaire  

B - 2.2 Provide information on the operation of your National Committee in relation to its 
task to advise competent authorities, including on how it aims to address coherent 
approach to project evaluation and review strategies at national level as provided in 
Recital 48 

In  a  few  Member  States,  the  National  Committee  has  also  assumed  the  task  of  project 
evaluation  for  all  projects  in  the  Member  State.  In  others,  the  competent  authorities  refer 
specified types of projects (for example those using non-human primates, or those presenting 
difficult  or  novel  ethical  challenges)  to  the  National  Committee  or  invite  their  view  on 
requests for exemption, for example, to conduct of procedures outside establishments. 

A  number  of  National  Committees  have  developed  templates  and  guidance  for  project 
applications  and  evaluations  to  facilitate  consistency.  These  have  been  found  to  be  helpful 
where  there  are  multiple  competent  authorities  responsible  for  project  evaluation.  In  a  few 
Member  States,  the  National  Committee  is  involved  in  training  of  project  evaluators. 
Standardised  formats  for  submission  of  non-technical  project  summaries  and  retrospective 
assessment have also been developed by some. Several National Committees are involved in 
oversight and approval of education and training courses for personnel involved in animal use 
and care. 

Competent  authorities  in  many  Member  States  have  utilised  the  National  Committee  to 
address specific questions, but the level of consultation varies significantly, with one response 
indicating that the National Committee had received no requests from competent authorities. 
Other  National  Committees  have  been  consulted  by  competent  authorities,  for  example  on 
appropriate  accommodation  and  care  practices  for  species  without  detailed  requirements  in 
Annex III. National Committees have also been invited to develop guidance on specific areas 
of  scientific  use  and  care,  for  example  on  staff  responsibilities  for  animal  use  and  care,  on 
rehoming and, on advice to avoid duplication of procedures. 

2.3.Advice to Animal Welfare Bodies 

Question in the questionnaire  

B - 2.3 Provide information on the operation of your National Committee in relation to its 
task to advise animal welfare bodies 

In  the  majority  of  Member  States,  National  Committees  have  developed  effective 
communication channels with Animal Welfare Bodies to disseminate relevant information and 
have provided mechanisms for Q&A and sharing of best practice. In some Member States the 
ministry(/ies)/authorities remain a valuable source of information. 

6 https://ec.europa.eu/environment/chemicals/lab_animals/nc_en.htm 

12 

 
 
                                                           
A few National Committees have invited contributions from Animal Welfare Bodies by means 
of questionnaires to inform and focus their future work programme. 

Provision of up-to-date information on replacement (alternatives) has been requested of a few 
National  Committees.  One  National  Committee  reported  that  no  advice  had  been  sought  by 
Animal Welfare Bodies. 

2.4.Sharing of best practice 

Question in the questionnaire 

B - 2.4 Provide information on the operation of your National Committee in relation to its 
task to share best practice 

Some National Committees have organised meetings of Animal Welfare Bodies and arranged 
training  sessions  for  Animal  Welfare  Body  members,  for  example,  a  symposium  on 
experimental design. 

One  Member  State  hosts  an  annual  symposium  to  showcase  best  practice  initiatives,  and 
provides financial support to encourage further improvements. 

Symposia  are  organised  by  some  National  Committees  on  relevant  topics,  for  example 
neurological  and  psychiatric  models,  promoting  consistency  in  statistical  reporting,  and 
procedural training for animals. 

Good practice guidance has been developed on a number of topics, either at the request of the 
competent  authority,  feedback  from  Animal  Welfare  Bodies,  or  on  their  own  initiative. 
Examples include guidelines on tumour models, blood  sampling, recognising and alleviating 
pain, water and food restriction for scientific reasons. 

Questions in the questionnaire [voluntary question] 

* B - 2.5 Has the EU Guidance on Animal Welfare Bodies and National Committees 
been made available to the members of National Committee and establishment Animal 
Welfare Bodies? 

EU Guidance made available 

Yes 
No 
No response 
Total 

25 
1 
2 
28 

Question in the questionnaire [voluntary question] 

*  B - 2.6  Has  additional  official  guidance  for  Animal  Welfare  Bodies  and  National 
Committee been developed to facilitate implementation? 

Additional guidance developed 

Yes 
No 

7 
18 

13 

 
 
 
No response 
Total 

3 
28 

Question in the questionnaire [voluntary question] 

* B - 2.6.bis If you consider this guidance helpful for other Member States to facilitate the 
implementation  of  the  Directive,  please  provide  web-address  for  the  guidance,  where 
available 

Some  Member  States  have  developed  additional  guidance  and  websites  are  provided  in  the 
detailed Member State summaries.  

B.3. Education and training of personnel (Article 23 of Directive 2010/63/EU) 

Reporting obligation  

“information on the minimum requirements referred to in Article 23(3) of Directive 2010/63/EU 
including  any  additional  educational  and  training  requirements  for  staff  coming  from  another 
Member State.” 

Background: 

Directive provides, in its Article 23 that 

“1. Member  States shall ensure that each breeder,  supplier and user has sufficient  staff 
on site.  

2.  The  staff  shall  be  adequately  educated  and  trained  before  they  perform  any  of  the 
following functions:  

(a) carrying out procedures on animals;  

(b) designing procedures and projects;  

(c) taking care of animals; or  

(d) killing animals.  

Persons carrying out the functions referred to in point (b) shall have received instruction 
in  a  scientific  discipline  relevant  to  the  work  being  undertaken  and  shall  have  species-
specific knowledge.  

Staff carrying out functions referred to in points (a), (c) or (d) shall be supervised in the 
performance of their tasks until they have demonstrated the requisite competence.  

Member  States  shall  ensure,  through  authorisation  or  by  other  means,  that  the 
requirements laid down in this paragraph are fulfilled. 

3. Member States shall publish, on the basis of the elements set out in Annex V, minimum 
requirements  with regard to  education and training  and the requirements  for  obtaining, 
maintaining  and  demonstrating  requisite  competence  for  the  functions  set  out  in 
paragraph 2.  

14 

 
 
 
4.  Non-binding  guidelines  at  the  level  of  the  Union  on  the  requirements  laid  down  in 
paragraph  2  may  be  adopted  in  accordance  with  the  advisory  procedure  referred  to  in 
Article 56(2).” 

Analysis 

Question in the questionnaire 

B - 3.1 Provide information on the minimum requirements for education and training for 
functions in Article 23(2) 

The  level  of  detail  and  clarity  in  responses  vary  significantly,  making  it  challenging  to 
determine  with  certainty  what  the  exact  training  requirements  are  across  the  EU.  It  is 
important to note in this context that education and training matters remain the competence of 
the Member States, although minimum requirements are listed in the Directive (see Annex V 
of the Directive). 

The national legislation requires appropriate education and training for the personnel listed in 
Article  23(2).  General  requirements  are  included  in  national  legislation,  the  majority  of 
Member  States  have  published  the  EU  Guidance  document  on  Education  and  Training 
Framework7  and  a  minority  have  produced  additional  Member  State  guidance.  Several 
Member States reported that recent improvements in training provision are underway. 

Some Member States state that there are minimum educational requirements, including higher 
education degrees required for the role as project designer in several Member States. 

From the information provided  

Training courses are provided 

Number of MS  

Accredited  and/or  MS  approved 
courses 
Training  course  provided  but  not 
formally accredited/approved 
Local/establishment level training  
Unclear 
None 

6 

4 

5 
10 
3 

Accredited/Member  State  approved  courses  seem  to  be  available  only  in  a  minority  of 
Member  States.  Training  courses  without  reported  quality  assurance  are  provided  by  a  few 
others.  Local  training  and  supervision  occurs  in  some  Member  States,  and  what  training,  if 
any, is delivered in other Member States is unclear on the basis of the responses.  

Some Member States define a syllabus for training  courses and some determine a minimum 
duration  of  training,  which  can  differ  between  Member  States.  Many  training  courses  still 
relate  to  teaching  hours,  or  numbers  of  lessons,  but  not  attainment  of  specific  Learning 
Outcomes  –  contrary  to  what  is  promoted  in  the  EU  Guidance  document  on  Education  and 
Training Framework endorsed by the Member States. 

7 https://ec.europa.eu/environment/chemicals/lab_animals/pdf/guidance/education_training/en.pdf  

15 

 
 
 
                                                           
A  small  number,  perhaps  as  many  as  nine,  seem  to  have  implemented  the  EU  guidance 
document  on  Education  and  Training  Framework.  For  others  it  is  unclear  how  quality  of 
training ensures that all necessary learning is acquired to an adequate standard.  

In three cases, while training courses are required, they may be completed within the first 6-12 
months  of  starting  work.  It  was  not  clear  from  the  responses,  whether  it  is  systematically 
required that these persons, when working with animals, work under supervision as obliged by 
the Directive, until such time training is completed and competence demonstrated. 

From the responses provided (November 2018), there seem to be three Member States where 
no formal requirement for training have been adopted.  

 

Italy:  “With  regard  to  the  information  on  the  minimum  requirements  for  education  and 
training of staff referred to in Article 23(2) of D.lgs. 26/2014, we should point out that no 
ministerial decree governing this matter has yet been issued” 

  Cyprus: “So far there are general requirements for education and training for functions in 
Article  23(2)  and  these  are  fulfilled  via  authorization  of  the  persons  who  carry  out 
procedures  on  animals  (personal  license)  and  via  evaluation  of  the  competence  of  the 
persons designing procedures and projects during project evaluation. Moreover, in 2019 
the National Committee schedules to start organizing training programs for all functions 
so that the education and training is more consistent and invariable” 

  Romania:  “There  are  no  specific  requirements  other  than  those  established  by  law.  A 
specific legal order on training for functions in Art. 23(2) is currently being drafted;” 

Greece  indicated  that  a  ministerial  decision  regulating  the  procedures  required  in  order  to 
authorise training of scientific associations or other training bodies and training programs for 
all four functions is about to be issued. 

There  remain  differing  requirements  among  Member  States  for  training  of  personnel  under 
Article  23,  in  terms  of  course  content,  duration  and  minimum  educational  requirements, 
although there are now mechanisms in place in the majority of Member States to consider the 
suitability  of  training  elsewhere  when  applications  are  submitted,  to  avoid  unnecessary 
duplication of training, costs and delays to the personnel concerned. 

Question in the questionnaire 

B – 3.2 Provide information on the requirements for obtaining, maintaining and 
demonstrating requisite competence for functions in Article 23 (2) – that is carrying out 
procedures on animals, taking care of animals or killing animals 

Information,  often  repetition  from  earlier  question  in  the  questionnaire,  was  provided  on 
training  courses,  but  little  on  attainment  and  maintenance  of  competence,  which  was  a  new 
obligation  introduced  by  the  Directive.  It  is  not  clear  in  many  responses  what  systems  are 
required to ensure attainment and maintenance of competence. 

In  some  Member  States,  it  is  the  responsibility  of  the  establishment  to  train  and  ensure 
competence of the personnel, seemingly in the absence of formal training courses. Within the 
establishment,  this  is  often  effected  by  the  person  identified  in  Article  24(1)(c)  –  person 

16 

 
 
 
 
responsible  for  ensuring  staff  are  adequately  educated,  supervised  until  competent,  that 
competence is maintained and that they are continuously trained. 

This is a new requirement for Member States  and acknowledgement was made that in many 
Member States there are no formal systems for supervision and competence assessment. A few 
Member States noted that further guidance was in preparation, and some training providers are 
working  on  measures  for  consistent  assessment  of  competence  (for  example  DOPS  –  Direct 
Observation of Procedural/practical Skills). 

Some Member States indicated that if staff had not been working with animals for a specified 
period  of  time,  the  individual  would  have  to  undergo  re-training  and/or  a  period  of 
supervision. 

One  Member  State  noted  that  annual  refresher  training  would  be  provided  by  the 
establishment, and that if there are extended breaks between carrying out any of the tasks, re-
training  would  be  required.  A  few  (for  example  Spain,  Luxembourg  and  Slovakia)  noted 
formal requirements for maintaining standards (CPD – Continued Professional Development), 
and some professional organisations, for example for veterinarians  and animal technologists, 
have published guidance.  

Despite the diversity of training, there were no comments suggesting that lack of competence 
was an issue. It was often noted that implementation of education and training requirements, 
including  attainment  and  maintenance  of  competence,  is  checked  during  inspections, 
suggesting  that  there  is  oversight  of  outcomes  (at  least  in  some  Member  States)  and  that  if 
training were less than ideal, it could be identified and remedied. 

A few responses giving examples of some different approaches to supervision and competence 
assessment are included below  

  Spain: “Maintenance of training: 

1. The initial training shall be maintained through ongoing training activities. 
2.  The  ongoing  training  activities  shall  aim  to  ensure  the  improvement  and  updating  of 
the skills and knowledge initially acquired and shall meet the following conditions 

a)  They shall include the delivery of or attendance at courses, seminars, lectures, 
workshops  or  scientific  conferences;  authorised  stays  in  research  centres  or 
other  similar  activities  which  are  specified  by  the  competent  bodies  and  are 
aimed  at  learning  about  new  or  updated  techniques,  methods  or  rules 
applicable to animal experiments. 

b)  They shall be related to the learning outcomes of the modules corresponding to 

the function in question.  

c)  As a whole, they shall have the minimum duration set out in Annex III for each 

function.  

d)  They  shall  be  accredited  through  diplomas  or  certificates  of  attendance  in 

which reference is made to their content and duration.  

e)  Their  content  shall  enable  the  training  for  one  or  more  functions  to  be 

maintained.  

f)  They  shall  respect  the  conditions  laid  down  for  the  use  of  live  animals  in 

training courses.” 

17 

 
 
 
 
  Luxembourg:  “The  framework  for  obtaining  the  competence  for  carrying  procedures, 
taking  care  of  animals  and  performing  euthanasia  begins  with  the  trainee  initially 
observing  the  procedures/euthanasia/taking  care  of  animals  being  carried  out,  he  then 
carries  out  the  procedures/euthanasia/taking  care  of  animals  under  close  supervision 
until  competency  is  acquired.  The  supervision  period  and  the  time  until  competency  is 
attained vary for each individual, the task being performed, technical complexity and the 
ability  of  the  individual.  Only  after  full  competency  has  been  attained  the  trainee  is 
allowed to conduct the procedure/ euthanasia/ taking care of animals unsupervised. The 
demonstration and the assessment of requisite competence is performed by the designated 
veterinarian  (Article  25)  or/and  the  person  responsible  for  education,  competence  and 
CPD (Article 24). The progress of obtaining requisite competence for functions listed in 
Article 23§2 must be documented in a record at the breeder/supplier/user establishment 
for each individual and for each procedure, function and task.” 

  Netherlands:  “The  person  (responsible  for  training)  checks  that  staff  are  trained  in 
accordance  with  the  requirements,  both  in  theoretical  subjects  in  order  to  maintain 
competence (additional and continuing development) and in practical subjects in order to 
maintain  or  obtain  proficiency  (skill).  Although  the  Dutch  authorities  leave  open  the 
possibility of laying down more detailed requirements, there are at present no additional 
rules regarding the continuing development of staff who carry out procedures on animals 
or who design animal experiments” 

  Slovenia:  “The  basic  training  for  animal  keepers  and  persons  responsible  for  killing 
animals  comprises  at  least  30  lessons,  whereas  the  basic  training  for  persons  who 
perform  procedures  on  animals  comprises  at  least  40  lessons.  After  a  person  has 
successfully completed his or her basic training, he or she works under the supervision of 
a mentor for at least six months. The mentor is appointed by the animal welfare expert in 
the organisation where the above-mentioned persons work. When a person demonstrates 
the requisite professional competence, the animal welfare expert enters him or her in the 
register  of  qualified  persons  on  the  basis  of  the  mentor’s  written  opinion.  The  persons 
referred  to  in  Article  23(2)  (a),  (c)  and  (d)  of  the  Directive  must  maintain  their 
professional competence through regular work, by keeping up to date and by refreshing 
their knowledge in their scientific or professional field, as demonstrated by scientific or 
expert publications or by participating in scientific or expert meetings within five years of 
the  completion  of  basic  training.  The  further  training  of  animal  keepers  and  persons 
responsible  for  killing  animals  must  comprise  at  least  four  lessons,  whereas  the  further 
training of persons who perform procedures must comprise at least eight lessons. 

  Finland:  “After  the  theoretical  education  &  training,  persons  may  get  more  practical 
training when necessary. They work under supervision until they have needed knowledge 
and  skills.  The  demonstration  and  assessment  for  the  official  competency  is  not  yet 
working. This is, however, under a joint development – the assessment, assessment forms 
and training of evaluators are planned in the working group of FinLAS. The goal is that 
this process will be working 2019.” 

Questions in the questionnaire  

18 

 
 
 
 
 
 
 
B - 3.3 Are there any additional education and training requirements for staff coming from 
another Member State? 

B - 3.3.bis Provide information on additional education and training requirements for staff 
coming from another Member State 

The  2017  review  of  the  Directive8  suggested  that  there  were  still  difficulties  for  staff  and 
researchers in moving between Member States as education and training requirements differed 
and additional training was required, causing delays in being able to start work. 

There  was  acknowledgement  in  some  Member  States  of  acceptability  of  training  courses, 
which  had  been  provided  by  other  Member  States  or  other  external  course  accreditors,  for 
example  FELASA9,  such  that  persons  coming  from  another  Member  State  need  not 
necessarily  complete  all  within-Member  State  training.  Details  are  generally  checked  by  the 
competent authority during assessment of an application for authority to work with animals in 
scientific procedures. 

Only eight Member States (Belgium, Denmark, Ireland, France, Netherlands, Poland, Portugal 
and United Kingdom) indicated that there were additional training requirements for personnel 
coming from another Member State. 

Of  these  responses,  six  indicated  that  training  in  local  legislation  and  practices  would  be 
required. In Denmark there is an e-learning module available. 

The UK requires further additional training for project designers and applicants.  

The  competent  authorities  will  assess  the  previous  training  of  the  applicant  to  determine 
whether any further additional training will be necessary. If training in another Member state 
has been completed and is determined to be equivalent, then the other Member State training 
is accepted. 

There  is  evidence  that  training  from  other  Member  States  is  recognised  by  some  others 
allowing exemption from repeated training in the new Member State. 

Question in the questionnaire [voluntary questions]   

*  B  -  3.4  Has  the  EU  Guidance  on  Education  and  Training  Framework  been  made 
available to those responsible for education, training and competence in establishments? 
See table below (3.5). 

* B - 3.5 Have specific training requirements been introduced by authorities for persons 
in Articles 24, 25 and 38 as recommended by the EU Guidance? 

*  B  - 3.6  Has  additional  official  guidance  on  education,  training  and  competence  been 
developed to facilitate implementation? 

8 https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1510219889073&uri=COM:2017:631:FIN  
9 Federation for Laboratory Animal Science Associations 

19 

 
 
 
 
                                                           
* B - 3.6.bis If you consider this guidance helpful for other Member States to facilitate the 
implementation  of  the  Directive,  please  provide  web-address  for  the  guidance,  where 
available? 

EU 
Guidance 
made 
available 

MS 
Guidance 
produced 

Training 
of named 
welfare 
and care 
persons 

Yes 
No 
Unclear 
Blank 
Total 
No+Blank 
Grand total 

24 
4 

4 

28 

4 
19 

5 
24 

28 

8 
12 

8 
20 

28 

Training of 
named 
person 
responsible 
for 
information 
5 
15 

8 
23 

28 

Training 
of DV 

Training 
of project 
evaluators 

Training of 
named 
person 
responsible 
for training 

5 
15 

8 
23 

28 

8 
11 
1 
8 
19 

28 

4 
16 

8 
24 

28 

Specific training relevant to animal care is required for any person responsible for animal care 
and  welfare  in  a  number  of  Member  States,  with  some  but  not  all  requiring  degree  level 
training.  Few  Member  States  have  requirements  for  training  of  person  responsible  for 
information.  In  some  cases,  joint  posts  are  held  with  the  person  responsible  for  care  and 
welfare.  

Designated Veterinarian (DV) training: Responding countries mentioned the requirement to be 
a trained / practising veterinarian. One Member State mentioned an option to appoint another 
relevant  expert,  with  species  specific  knowledge  and  expertise  as  a  requirement.  Only  one 
country (the UK) reported a specific training course for DV. Some countries have additional 
training  requirements  for  DVs  including  attending  modules  for  other  functions.  Some 
mentioned the importance of CPD.  

These figures and statements show that many Member State have yet to develop training for 
the persons named in Article 24 of the Directive. 

Five  Member  States  reported  that  they  had  developed  additional  guidance  and  four  of  these 
have provided weblinks available in the detailed Member State summaries. 

B.4. Project evaluation and authorisation (Articles 38 and 40 of Directive 2010/63/EU) 

Reporting obligation:  

“description of the processes of project evaluation and authorisation and how the requirements 
of Articles 38 and 40 of Directive 2010/63/EU are met” 

Background: 

The Directive provides the following in its Article 38 on project evaluation: 

1. The project evaluation shall be performed with a degree of detail appropriate for the 
type of project and shall verify that the project meets the following criteria:  

20 

 
 
 
 
 
 
 
 
 
 
 
(a) the project is justified from a scientific or educational point of view or required 
by law;  

(b) the purposes of the project justify the use of animals; and  

(c) the project is designed so as to enable procedures to be carried out in the most 
humane and environmentally sensitive manner possible.  

2. The project evaluation shall consist in particular of the following:  

(a) an evaluation of the objectives of the project, the predicted scientific benefits or 
educational value;  

(b)  an  assessment  of  the  compliance  of  the  project  with  the  requirement  of 
replacement, reduction and refinement;  

(c) an assessment and assignment of the classification of the severity of procedures; 

 (d) a harm-benefit analysis of the project, to assess whether the harm to the animals 
in  terms  of  suffering,  pain  and  distress  is  justified  by  the  expected  outcome  taking 
into  account  ethical  considerations,  and  may  ultimately  benefit  human  beings, 
animals or the environment;  

(e) an assessment of any justification referred to in Articles 6 to 12, 14, 16 and 33; 
and  

(f)  a  determination  as  to  whether  and  when  the  project  should  be  assessed 
retrospectively.  

3. The competent authority carrying out the project evaluation shall consider expertise in 
particular in the following areas:  

(a) the areas of scientific use for which animals will be used including replacement, 
reduction and refinement in the respective areas;  

(b) experimental design, including statistics where appropriate;  

(c)  veterinary  practice  in  laboratory  animal  science  or  wildlife  veterinary  practice 
where appropriate;  

(d)  animal  husbandry  and  care,  in  relation  to  the  species  that  are  intended  to  be 
used.  

4. The project evaluation process shall be transparent.  

Subject  to  safeguarding  intellectual  property  and  confidential  information,  the  project 
evaluation  shall  be performed in  an impartial manner and may  integrate the opinion of 
independent parties” 

And on project authorisation in its Article 40 that: 

“1. The project authorisation shall be limited to procedures which have been subject to:  

(a) a project evaluation; and  

(b) the severity classifications assigned to those procedures.  

21 

 
 
2. The project authorisation shall specify the following:  

(a) the user who undertakes the project;  

(b)  the  persons  responsible  for  the  overall  implementation  of  the  project  and  its 
compliance with the project authorisation;  

(c) the establishments in which the project will be undertaken, where applicable; and  

(d)  any  specific  conditions  following  the  project  evaluation,  including  whether  and 
when the project shall be assessed retrospectively.  

3. Project authorisations shall be granted for a period not exceeding 5 years.  

4. Member States may allow the authorisation of multiple generic projects carried out by 
the same user if such projects  are to  satisfy regulatory requirements  or  if such projects 
use animals for production or diagnostic purposes with established methods.” 

Analysis 

Questions in the questionnaire  

B - 4.1 Have the processes of  project evaluation and authorisation  been  published as a 
means to implement the requirement of Article 38(4)? 

B - 4.1.bis Please provide the web-address where these processes can be found [voluntary 
question] 

B  -  4.1.tris Please  explain  how  the  obligation  for  the  project  evaluation  process  to  be 
transparent has been achieved? 

22  Member  States  provided  web-links  to  the  published  processes  for  project  evaluation  and 
authorisation. Of the remaining Member States two referred to templates provided for project 
application  available  for  applicants  on  their  web-site.  Three  (Malta,  Slovakia  and  Slovenia) 
describe  briefly  their  respective  processes  but  not  how  the  transparency  of  the  process  is 
ensured. Lithuania reported non-technical summary publication as the means for transparency. 

Question in the questionnaire 

B  -  4.2  Explain  the  key  steps  of  the  project  evaluation  and  authorisation  processes 
including those for multiple generic projects and simplified administrative procedures in 
a Member State where these are allowed 

A  variable  amount  of  information  was  provided  by  Member  States,  which  has  made  it 
challenging to confirm that all the elements of project evaluation and authorisation processes 
have been adequately addressed. 

Many  Member  States  have  a  common  structure  for  application  to  facilitate  consistency  and 
invite  the  correct  information.  Guidance  on  completion  of  application  forms  is  available  in 
many Member States. Other tools include training for project applicants which is provided in a 
few  Member  States,  and  the  introduction  of  electronic  application  processes,  which  are 
reported to be speeding up the processing times. 

22 

 
 
 
Different  evaluation  processes  have  been  developed,  ranging  from  national  to  regional  and 
local processes. Equally, there are variable sizes to committee structures – from very large to 
small groups or evaluations by individuals (with other support where necessary). 

Some  utilise  local  establishment  processes  through  Animal  Welfare  Bodies  or  local  ethical 
review  groups  to  provide  further  information,  a  local  perspective  and/or  opinion  on  the 
application to better inform the evaluation process. 

Methods of decision making vary from simple majority, 2/3 majority to consensus. 

Refusals  tend to  be relatively low as applications are generally revised and improved during 
the  application  and  evaluation  process,  and  also  because  the  applicant  may  withdraw  an 
application before it is formally refused. 

Little  feedback  was  provided  on  training  of  evaluators  or  what  competencies  are  involved, 
equally only a few comments were received on the process of harm benefit assessment 

Some Member States do not describe the steps in the process, rather providing only the legal 
framework with little information on how the process works in practice. 

An appeals procedure was mentioned by a few - in other Member States no appeal against the 
project authorisation decision can be made. 

It  is  clear  that  most  Member  States  are  making  strenuous  efforts  to  comply  with  the 
requirements  of the Directive with  respect  to project  evaluation and  authorisation. There are 
multiple requirements in Article 38 and 40, and in most Member States, it cannot be concluded 
just from  responses to  question 4.2 that all requirements of these articles are complied with. 
However, much information on the process  is provided by most Member States and links to 
websites provided (see 4.1), which may provide more evidence of full compliance.  

Question in the questionnaire 

B  -  4.2.bis  Where  allowed,  please  explain  what  type  of  projects  are  accepted  under 
simplified administrative procedure? 

Not all Member States use the option of the simplified administrative procedure; 10 Member 
States report using it and a small number of others have it available, but have not yet used it. 
Not all Member States utilise the option of multiple generic projects. 

Types  of  projects  reported  to  be  accepted  under  simplified  administrative  procedure,  were 
largely as permitted in Article 42, that is projects 

  necessary to satisfy regulatory requirements,  
  which use animals for production or diagnostic purposes with established methods, and 
  animal  experiments  carried  out  to  produce,  obtain,  preserve  or  propagate  substances, 

products or organisms using established methods. 

And which  

  contain only procedures classified as ‘non-recovery’, ‘mild’ or ‘moderate’, and 
  are not using non-human primates. 

23 

 
 
to  animals 
Some  Member  States  require  reports  of  substances 
retrospectively, and one that if severe harms occur the project leader needs to submit a non-
technical project summary, which is not required at the point of authorisation. Several do not 
require non-technical project summaries for this type of project. 

tested  and  harms 

Question in the questionnaire 

B - 4.3 What is the maximum length (in years) for a project authorisation implementing 
the requirement under Article 40(3)? 

All Member States reported maximum durations of five years except one, Greece, where only 
three years is permitted. 

Question in the questionnaire  

B - 4.4 Explain how the requirement for expertise for project evaluation in Article 38 (3) 
is considered. 

There  appeared  to  be  some  variation  in  how  this  article  has  been  interpreted,  leading  to 
differences  in  responses.  Contrary  to  the  intention  of  the  Directive,  a  significant  number  of 
Member States appear to have interpreted the requirement to be that project evaluation should 
determine  whether  these  areas  of  expertise  are  available  for  the  project,  not  the  evaluation 
process. 

Many  Member  State  responses  replicated  the  competencies  set  out  in  Article  38.  Eight 
Member States specifically stated that the project evaluation process involves expertise in all 
four  areas.  Others  responded  how  the  required  expertise  set  out  in  Article  38(3)  would  be 
considered as part of the evaluation process. However, very little information was provided on 
what  competences  were  involved  and  whether  training  was  provided  for  those  tasked  with 
project evaluation. 

The  importance  of,  as  well  as  the  difficulty  of,  getting  expertise  in  experimental  design  and 
statistics  was  emphasised,  as  well  as  expertise  in  particular  scientific  areas,  especially  if 
dealing with projects in narrow fields with few experts. 

A number of project evaluation systems retained the option of co-opting external expertise in 
specific  subjects,  where  the  main  committee  may  not  have  sufficient  knowledge  to  offer  an 
opinion. 

In a small number of Member States, the systems were still evolving. 

Questions in the questionnaire 

B - 4.5 Explain if and how the opinions of independent parties are integrated as provided 
in Article 38(4)  

B  -  4.7  When  project  evaluation  is  tasked  to  a  non-public  authority  and/or  within  an 
establishment, please describe how the impartiality of the process is achieved, in line with 
Article 38(4) 

24 

 
 
 
The  Directive  allows  the  option  to  integrate  independent  parties  in  the  process,  but  few 
Member States reported utilising them. Responses indicated that independent parties may be 
integrated  within  ethics  committees  or  national  committees  providing  advice  on  project 
evaluation, or may be called upon if required. In some cases, these independent members are 
from animal welfare organisations, medical doctors, patient group representatives, or members 
of staff within the establishment not involved in research.   

15 Member States reported having a single competent authority performing project evaluation 
(based  on  responses  provided  to  question  B.1  on  competent  authorities).  Whilst  not 
specifically reported, it is assumed that these are public bodies and are therefore independent. 
Of the remaining 13 Member States, seven are public bodies for project evaluation, and 11 for 
project  authorisation.  When  conducted  by  public  authorities  there  should  be  no  issues  of 
impartiality. 

Most Member States reported that conflict of interest is addressed by requiring that committee 
members do not take part if their own work, or that of a family member, or department’s work 
is  being  assessed.  This  is  an  issue  in  particular  for  project  evaluation  performed  by  local 
committees. Declarations are used to state impartiality/lack of conflict of interest. 

In the case of local committees, in some cases there is reported oversight by an independent 
member  of  the  government  department  which  implements  the  Directive,  or  a  second  tier  of 
review at national level.  

A  few  Member  States  actively  encourage  independent  involvement  in  the  process.  For 
example,  in  Poland  3/12  members  of  the  local  evaluation  committees  are  representatives  of 
organisations promoting animal welfare, and 1/12 must also represent an organisation whose 
statutory aims include the protection of patients’ rights. Sweden requires half of the members 
in the ethics committees are laypersons who are included to represent society’s point of view 
regarding benefit and necessity of research versus ethical justification of harm inflicted to the 
animals.  Two  of  these  laypersons  represent  animal  welfare  organisations.  Another  Member 
State encourages involvement of persons within the establishment who are not involved in the 
scientific programmes to provide a “lay” perspective.  

Question in the questionnaire  

B - 4.6 The decision within the project evaluation process is reached by 

Decision reached by 

Consensus 
Vote or simple 
majority 
Other 
Total 

9 
11 

8 
28 

Where  vote  or  simple  majority  or  other  were  reported,  these  are  mostly  by  simple  majority 
with  a  chairman’s  casting  vote  following  discussion.  One  Member  State  reported  that 
members are given the opportunity to register dissent from the decision, which is included in 
the report on the evaluation. One Member State reported that there is variability between the 

25 

 
 
 
different  competent  authorities  responsible  for  project  evaluation  on  how  decisions  are 
reached. 

Question in the questionnaire [voluntary question] 

*  B  -  4.8  Two  key  elements  which  impact  on  the  project  evaluation  and  authorisation 
processes  are  the  definition  of  "a  project"  and  the  interpretation  of  "a  complete  and 
correct  application  please  provide  a  short  description  of  the  types  of  "projects" 
authorised in your MS - e.g., are projects limited to single procedures of short duration or 
are  more  complex  multi-species,  multi-procedure  projects  of  up  to  5  years  also 
authorised; how is a "complete and correct application" determined, and communicated 
to  applicant;  how  are  the  interactions  between  applicant  and  competent  authority 
accounted for in the authorisation deadlines as required in Article 41 

Background: 

During  the  review  of  the  Directive10,  a  number  of  comments  were  raised  over  the  apparent 
interpretation of the term “project”, suggestive that there were Member States who had taken a 
very narrow interpretation, effectively only authorising single procedures as projects. 

In  the  review  responses,  it  was  also  reported  that  delays  were  being  encountered  and  the 
timescales  for  project  authorisation  were  not  being  met  as  the  “time  allowed”  did  not  begin 
until an entirely correct application was received for evaluation. 

Analysis 

Eighteen Member States have included a response to these non-mandatory questions. 

“project”  

The  majority  of  responses  confirmed  that  projects  vary  in  size  and  complexity,  and  can 
involve multiple procedures and species, and are issued for different periods up to a maximum 
of five years. 

“a complete and correct application” 

The  responses  confirmed  that  often  the  initial  application  for  a  project  contains  insufficient 
information to allow a full project evaluation to be undertaken. 

Member  States  have  different  structures  for  conducting  project  evaluation,  but  in  all 
circumstances  reported,  there  is  the  possibility  for  interaction  (and  indeed  this  is  regularly 
utilised)  with  the  applicant  to  secure  the  necessary  additional  information  to  allow  project 
evaluation to be undertaken. 

Correction/improvement  to  the  application  seems  the  preferred  solution,  rather  than  outright 
rejection of an initial incomplete application. 

Many Member States have issued a standard project application form together with guidance 
for completion, and a few provide training for applicants in the application requirements. 

10 https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1510219889073&uri=COM:2017:631:FIN 

26 

 
 
                                                           
Question in the questionnaire [voluntary question] 

* B - 4.9 - Are the processes for amendments to projects the same as for the initial project 
evaluation  and  authorisation  (including  the  deadlines  in  Article  41)?  If  not,  please 
describe  the  main  differences.  What  changes  to  a  project  will  require  a  request  for  an 
amendment? 

19 Member States responded to this non-mandatory question. 

All  indicated  that  any  changes  to  a  project  which  may  negatively  impact  on  animal  welfare 
would require a further, proportionate, evaluation. 

Many  responses  indicated  that  amendments  would  be  required  for  changes  to  projects,  not 
involving  additional  welfare  costs,  but  that  such  amendments  would  be  dealt  with  in  a 
different,  but  proportionate  manner,  for  example  through  Animal  Welfare  Bodies,  and 
generally these would be dealt with more quickly, and in a few cases by a simple notification. 

One  Member  State  (Malta)  indicated  that  a  new  application  would  be  required  on  each 
occasion an amendment was required. 

Question in the questionnaire [voluntary question] 

*  B  -  4.10  Has  the  EU  Guidance  on  Project  Evaluation  and  Retrospective  Assessment 
been made available to all project evaluators? 

EU Guidance made available 

Yes 
No 
No response 
Total 

24 
1 
3 
28 

Question in the questionnaire [voluntary question] 

*  B  -  4.11  Has  additional  official  guidance  on  project  evaluation  and  retrospective 
assessment been developed to facilitate implementation? 

Additional guidance developed 

Yes 
No 
No response 
Total 

7 
16 
5 
28 

Question in the questionnaire [voluntary question] 

* B - 4.11.bis If you consider this guidance helpful for other Member States to facilitate 
the implementation of the Directive, please provide web-address for the guidance, where 
available. 

Five Member States provided links to websites which may be helpful to others, available in 
the detailed Member State summaries. 

27 

 
 
 
 
C. OPERATION 

C.1. Projects 

C.1.i. Granting of project authorisation (Articles 40 and 41 of Directive 2010/63/EU) 

Reporting obligation 

“information  on  the  annual  number  of  projects  authorised,  and  on  the  number  and  type 
authorised as ‘multiple generic projects’;  

information on the circumstances and proportion of total authorisations where the deadline of 
40 days has been extended as permitted by Article 41(2) of Directive 2010/63/EU.”  

Background: 

The Directive provides the following in its Articles 40 and 41 on project authorisation: 

“Article 40 

Granting of project authorisation 

1. The project authorisation shall be limited to procedures which have been subject to:  

(a) a project evaluation; and  

(b) the severity classifications assigned to those procedures.  

2. The project authorisation shall specify the following:  

(a) the user who undertakes the project;  

(b)  the  persons  responsible  for  the  overall  implementation  of  the  project  and  its 
compliance with the project authorisation;  

(c) the establishments in which the project will be undertaken, where applicable; and  

(d) any specific conditions following the project evaluation, including whether and when 
the project shall be assessed retrospectively.  

3. Project authorisations shall be granted for a period not exceeding 5 years.  

4. Member States may allow the authorisation of multiple generic projects carried out by the 
same  user  if  such  projects  are  to  satisfy  regulatory  requirements  or  if  such  projects  use 
animals for production or diagnostic purposes with established methods.  

Article 41  

Authorisation decisions  

1.  Member  States  shall  ensure  that  the  decision  regarding  authorisation  is  taken  and 
communicated to the applicant 40 working days at the latest from the receipt of the complete 
and correct application. This period shall include the project evaluation.  

2.  When  justified  by  the  complexity  or  the  multi-disciplinary  nature  of  the  project,  the 
competent authority may extend the period referred to in paragraph 1 once, by an additional 

28 

 
 
 
period not exceeding 15 working days. The extension and its duration shall be duly motivated 
and shall be notified to the applicant before the expiry of the period referred to in paragraph 
1.  

for 
3.  Competent  authorities  shall  acknowledge 
authorisations as quickly as possible, and shall indicate the period referred to in paragraph 1 
within which the decision is to be taken.  

the  applicant  all  applications 

to 

4.  In  the  case  of  an  incomplete  or  incorrect  application,  the  competent  authority  shall,  as 
quickly as possible, inform the applicant of the need to supply any additional documentation 
and of any possible effects on the running of the applicable time period.“ 

Analysis 

Question in the questionnaire  

C - 1.i.1 Granting of project authorisations (Articles 40 and 41) 

Total EU projects 

Year 

Number of 
projects 
authorised 

2013 

2014 

2015 

2016 

2017 

6,063 

11,210 

15,044 

15,246 

16,708 

Total number 
of decisions 
(authorised and 
rejected) 
6,119 

11,226 

15,401 

15,849 

17,230 

total number 
rejected 
(calculated) 

Number of 
decisions 
>40days 

Proportions >40 
days of all 
decisions 

56 

16 

357 

603 

522 

945 

4,140 

5,289 

6,144 

6,951 

15% 

37% 

34% 

39% 

40% 

It is important to note in this context that the lower numbers during the first years reflects the 
fact that the Directive obligations had yet to be transposed in the national legislation in some 
Member States. The last Member State adopted national legislation only in the spring of 2015. 

A  comparison  of  numbers  of  authorised  projects  between  Member  States  is  less  informative 
due to differences in interpretation of what constitutes a project (see question B.4.8).  

However,  to  facilitate  competitive  EU  research,  the  Directive  introduced  a  40-day  deadline 
within which the decision has to be taken and communicated by the authorities. Only in cases 
justified by the complexity or the multi-disciplinary nature of the project, this deadline could 
be  extended  by  15  days.  There  are  significant  differences  between  Member  States  of  the 
proportion  of decisions  taken beyond 40 days,  varying from  0% to  100%. This  is  illustrated 
below with the data provided for 2017. Three Member states did not provide data on this. 

29 

 
 
 
 
 
 
Member 
State 

Number of 
projects 
authorised in 
2017 

Total number 
of decisions 
(authorised 
and rejected) 

Number 
rejected 
(calculated) 

Number of 
decisions >40 
days 

Proportions 
>40 days of all 
decisions 

AT 
BE 
BG 
CY 
CZ 
DE 
DK 
EE 
EL 
ES 
FI 
FR 
HR 
HU 
IE 
IT 
LT 
LU 
LV 
MT 
NL 
PL 
PT 
RO 
SE 
SI 
SK 
UK 

717 
1,605 
23 
6 
528*) 
3,800 
269 
17 
175 
1,569 
124 
3,708 
47 
206 
120 
1,005 
24 
22 
13 
1 
431 
774 
56 
114 
657 
18 
92 
587 

721 
1,621 
23 
6 
528 
3,800 
269 
17 
183 
1,569*) 
124 
3,708 
50 
271 
120 
1,264 
24 
22 
15 
1 
440 
914 
56 
114 
662 
28 
93*) 
587 

4 
16 
0 
0 
0*) 
0 
0 
0 
8 
0*) 
0 
0 
3 
65 
0 
259 
0 
0 
2 
0 
9 
140 
0 
0 
5 
10 
1*) 
0 

10 
146 
9 

3 
3,000 
31 
0 
15 
84 
0 
2,433 
9 
135 
3 
929 
24 
22 

0 
31 

34 
0 
20 
12 
0 
1 

1% 
9% 
39% 

1% 
79% 
12% 
0% 
8% 
5% 
0% 
66% 
18% 
50% 
3% 
73% 
100% 
100% 

0% 
7% 

61% 
0% 
3% 
43% 
0% 
>0% 

*) Numbers calculated from the data provided in the other columns 

Question in the questionnaire 

C - 1.i.1.bis Provide information of circumstances where the deadline of 40 days has been 
extended as provided in Article 41(2) 

Circumstances  for  the  deadline  being  extended  included:  projects  of  complex  or  of  a  multi-
disciplinary  nature,  where  large  numbers  of  animals  are  to  be  used,  where  large  amounts  of 
information  had  been  requested  of  applicants,  or  when  there  were  controversial  procedures 
being used. In some cases, it was reported that the deadline was exceeded because there were 
insufficient staff to process the applications. 

30 

 
 
 
 
 
 
 
 
 
 
Question in the questionnaire  

C - 1.i.2 Number and type authorised as "multiple generic projects” 

Total EU multiple generic projects 

Year 

2013 

2014 

2015 

2016 

2017 

Number of multiple 
generic projects 
authorised for 
regulatory purposes 

Number of multiple 
generic projects 
authorised for routine 
production 

Number of multiple 
generic projects 
authorised for 
diagnostic purposes 

Total number of 
multiple generic 
projects authorised 

Total number of 
projects authorised 
(from C1.i.1) 

Proportion of multiple 
generic projects of all 
authorised projects 

43 

148 

213 

223 

267 

20 

30 

37 

55 

79 

14 

58 

54 

82 

103 

77 

236 

304 

360 

449 

6,063 

11,210 

15,044 

15,246 

16,708 

1% 

2% 

2% 

2% 

2% 

31 

 
 
 
 
 
 
 
 
C.1.ii. Retrospective assessment, non-technical project summaries (Articles 38, 39 and 43 of 
Directive 2010/63/EU) 

Reporting obligation 

“information on the operation of non-technical project summaries; how it is assured that the 
requirements  under  Article  43(1)  of  Directive  2010/63/EU  are  met  and  whether  the  non-
technical project summaries will indicate projects chosen for retrospective review (Article 43 
(2) of Directive 2010/63/EU); 

information  on  the  proportion  and  types  of  projects  submitted  for  retrospective  assessment 
under Article 38(2)(f) of Directive 2010/63/EU beyond those compulsory under Article 39(2) 
of that Directive.” 

Non-technical project summaries 

Background 

Directive provides in its Article 44 the following: 

 “1.  Subject  to  safeguarding  intellectual  property  and  confidential  information,  the  non-
technical project summary shall provide the following: 

(a)  information  on  the  objectives  of  the  project,  including  the  predicted  harm  and 
benefits and the number and types of animals to be used; 

(b) a demonstration of compliance with the requirement of replacement, reduction and 
refinement. 

The  non-technical  project  summary  shall  be  anonymous  and  shall  not  contain  the  names 
and addresses of the user and its personnel. 

2.  Member  States  may  require  the  non-technical  project  summary  to  specify  whether  a 
project  is  to  undergo  a  retrospective  assessment  and  by  what  deadline.  In  such  a  case, 
Member  States  shall  ensure  that  the  non-technical  project  summary  is  updated  with  the 
results of any retrospective assessment. 

3. Member States shall publish the non-technical project summaries of authorised projects 
and any updates thereto.” 

Analysis 

Question in the questionnaire  

C – 1.ii.1 Provide information on the operation of non-technical project summaries; and 
on how it is assured that the requirements under Article 43(1) are met. Requirements of 
Article  43(1):  (a)  information  on  the  objectives  of  the  project,  including  the  predicted 
harm and benefits and the number and types of animals; (b) demonstration of compliance 
with the requirement of Replacement, Reduction and Refinement; (c) anonymity 

The essential requirements  for non-technical  project  summaries have been transposed in 
the national legislation of the Member States. 

32 

 
 
 
During the project evaluation process, the non-technical summaries should be checked for 
appropriateness  of  content,  and  that  the  summaries  do  not  contain  information  of  a 
confidential nature, or information which may compromise intellectual property rights.  

All  Member States  have a template  for non-technical  project  summaries  included in  the 
project application, with many using the EU template developed as guidance. 

It was acknowledged in a few responses that although initially the quality of the content 
and the time to publication were a concern (for example Italy), the content has improved 
as experience developed, and time to publication has been reduced as systems have been 
put in place to host these non-technical project summaries.  

One  Member  State  (Denmark)  reported  that,  subject  to  personal  data  and  IP  issues,  the 
full  contents  of  project  applications  are  published,  including  the  non-technical  project 
summaries. 

Question in the questionnaire  

C  -  1.ii.1.bis  Based  on  the  information  on  the  operation  the  non-technical  summaries 
during  the  first  five  years,  what  is  the  average  time  (in  months)  from  authorisation  to 
publication? 

Average time (in months) from authorisation to publication? 

Belgium 
Bulgaria 
Czechia 
Denmark 
Germany 
Estonia 
Ireland 
Greece 
Spain 
France 
Croatia 
Italy 
Cyprus 
Latvia 
Lithuania 
Luxembourg 
Hungary 
Malta 
Netherlands 
Austria 
Poland 
Portugal 
Romania 
Slovenia 
Slovakia 

18 
1 
1 
0 
3 
2 
6 
2 
6 
12 
12 
24 
2 
3 
2 
2 
5 
0 
1 
6 
1 
12 
3 
1 
6 

33 

 
 
 
 
Finland 
Sweden 
United Kingdom 

6 
36 
12 

In some cases Member States provided additional information on efforts made to improve the 
situation.  As  an  example,  Sweden  stated  that  “To  date,  only  few  non-technical  summaries 
have been published. However, the Swedish Board of Agriculture has recently finalised a new 
improved publishing format. The delay in publishing is unfortunate, and has resulted in a long 
average  time  from  authorisation  to  publication,  but  the  Board  now  envisions  a  steady 
publication rate in a user-friendly format.” 

Question in the questionnaire  

C  -  1.ii.2  Do  the  non-technical  project  summaries  indicate  projects  chosen  for 
retrospective assessment (Article 43(2)) 

NTS indicates projects selected for retrospective 
assessment 
Yes 
No 
Total 

13 
15 
28 

13 Member States have determined that they update the non-technical project summaries with 
the results of any retrospective assessment. 

Question in the questionnaire  

C  -  1.ii.3  Please  provide  the  web-address  where  non-technical  project  summaries  are 
published 

Links to Member State publications are now available on the Commission web-site at 
https://ec.europa.eu/environment/chemicals/lab_animals/nts_en.htm 

Retrospective assessment of projects  

Background 

Directive provides in its Article 38(2)(f) the following: 

“2. The project evaluation shall consist in particular of the following: 

…  

(f)  a  determination  as  to  whether  and  when  the  project  should  be  assessed 
retrospectively.” 

And in its Article 39 that: 

34 

 
 
 
 
 
 
 
1. Member States shall ensure that when determined in accordance with Article 38(2)(f), 
the retrospective assessment shall be carried out by the competent authority which shall, 
on the basis of the necessary documentation submitted by the user, evaluate the following:  

(a) whether the objectives of the project were achieved;  

(b) the harm inflicted on animals, including the numbers and species of animals used, and 
the severity of the procedures; and  

(c) any elements that may contribute to the further implementation of the requirement of 
replacement, reduction and refinement.  

2. All projects using non-human primates and projects involving procedures classified as 
‘severe’,  including  those  referred  to  in  Article  15(2),  shall  undergo  a  retrospective 
assessment.  

3.  Without  prejudice  to  paragraph  2  and  by  way  of  derogation  from  Article  38(2)(f), 
Member  States  may  exempt  projects  involving  only  procedures  classified  as  ‘mild’  or 
‘non- recovery’ from the requirement for a retrospective assessment.” 

Analysis 

Question in the questionnaire  

C  -  1.ii.4  Provide  information  on  the  proportion  and  types  of  projects  submitted  for 
retrospective assessment (RA) beyond those compulsory under Article 39(2) 

Projects required to have Retrospective Assessment -  all Member States 

Year 

2013 

2014 

2015 

2016 

2017 

Number of 
projects 
involving 
non-human 
primates 
(NHP) 

Number of 
projects 
involving 
severe 
procedures 

Number of 
projects 
involving 
NHP and 
severe 
procedures 

6 

15 

21 

34 

51 

559 

776 

1,477 

1,475 

1,528 

4 

0 

0 

7 

7 

Number of 
"other" 
projects 
(than those 
involving 
NHP/severe 
procedures) 
submitted for 
RA 
886 

1,120 

1,595 

1,475 

1,573 

Total 
number of 
projects 
submitted for 
RA (sum of 
previous four 
columns) 

Proportion of 
"other" 
projects 
versus all 
authorised 

1,464 

1,968 

3,274 

3,403 

3,721 

61% 

60% 

49% 

43% 

42% 

It is important to note in this context that the lower numbers in the Member State submissions 
during the first years reflect the fact that the Directive obligations had yet to be transposed in 
the  national  legislation  in  some  Member  States.  The  last  Member  State  adopted  national 
legislation only in the spring of 2015. 

Furthermore, it should be noted that some Member States (for example United Kingdom) had 
misunderstood this question to refer to completed retrospective assessments, instead of those 

35 

 
 
 
selected,  during  project  evaluation  (Article  38(2)(f)  between  2013  and  2017,  for  future 
retrospective assessment after the completion of the project. In addition, Germany stated that 
roughly 10% (during years 2013-2017) is requested for retrospective assessment beyond those 
compulsory,  without  providing  any  numbers.  France  and  Spain  provided  numbers  for  only 
those beyond compulsory but not of those required by law.  

Due to the lack of exact numbers from Member States presenting some of the highest volumes 
of animal use in EU (Germany, Spain, France and United Kingdom) the accuracy of the total 
value of the above table is likely to be poor. Of the remaining Member States, the proportion 
called for retrospective assessment beyond those compulsory is relatively high, above 40%. 

Question in the questionnaire  

C - 1.ii.5 Provide reasons for other projects (beyond those compulsory) being submitted 
for retrospective assessment broken down by each reporting year 

Many Member States applied a requirement for retrospective assessment for projects (beyond 
those compulsory) for a number of reasons. These reasons fell into a number of categories: 

Refinement - examples included: 

to ensure suitability of severity scoring sheets; 
to review monitoring during procedures - potential cumulative suffering; 
to review impact of an extended duration of the procedure on the animals; 
to review the effectiveness of proposed humane endpoints;  

 
 
 
 
  projects from which further insights might be gained on the actual functioning 

of refinement strategies; 

  project where mortality rate of 20-30 % was expected; 
 
 

to review impact on animals being reused in oncological tests; 
to review fate of animals when being released or rehomed. 

Reduction - examples included: 

  uncertainty over the number of animals born and used during the experiment; 
  projects involving large numbers of animals; 
  uncertainties over proposed design or group sizes. 

Uncertainty - examples included: 

  complex  pathway  of  experiments  with  multiple  options  making  severity 

assessment challenging; 

  project  involving  the  use  of  complex  technology  and  lengthy  anaesthetic 

episodes; 

  project  involved  a  novel  disease  model  with  the  potential  to  cause  higher 

suffering than predicted; 

  unknown effects of device implantation and possible rejection; 
  multiple generic projects -  useful to  review the individual studies performed 

under generic authorisation; 

36 

 
 
  
  use of models not well established within that particular research group, within 

the establishment, or not well established in any location; 
  newly authorised establishment and their first ever project. 

Other – examples included: 

  projects  using  animals  for  education  purposes  within  the  universities, 

especially to review the availability of alternatives; 

  project using wild and / or endangered species. 

C.2. Animals bred for use in procedures (Articles 10, 28 and 30) 

C.2.i. Animal bred, killed and not used in procedures 

Reporting obligation  

“animals  bred,  killed  and  not  used  in  procedures  including  genetically  altered  animals  not 
covered  in  the  annual  statistics,  covering  the  calendar  year  prior  to  that  in  which  the  5-year 
report  is  submitted;  the  global  figure  shall  differentiate  those  animals  involved  in  GA  creation 
and maintenance of established GA-lines (including wild-type offspring)” 

Background 

Directive provides in its Article 10(1) the following: 

“1.  Member  States  shall  ensure  that  animals  belonging  to  the  species  listed  in  Annex  I 
may  only  be  used  in  procedures  where  those  animals  have  been  bred  for  use  in 
procedures. ..” 

And in its Article 30 on animal records that: 

“1. Member States shall ensure that all breeders, suppliers and users keep records of at 
least the following: 

(a)  the  number  and  the  species  of  animals  bred,  acquired,  supplied,  used  in 
procedures, set-free or rehomed; 

… 

(f)  the  number  and  species  of  animals  which  died  or  were  killed  in  each 
establishment…” 

Analysis 

Question in the questionnaire  

C - 2.i Animals bred, killed and not used in procedures including genetically altered (GA) 
animals not otherwise reported in the annual statistics. This section covers animals only 
from  the  last  calendar  year  preceding  submission  of  information  for  the  5-year 
implementation report, that is 2017. 

Columns  3  and  4  exclude  animals  that  were  genotyped  using  invasive  method  as  these 
have already been included in the annual statistics. Equally, any animal from a harmful 

37 

 
 
phenotype line that experienced adverse effects before being killed will already have been 
reported. 

This  element  of  the  implementation  report  will  provide  complementary  information  to  the 
annual statistical data reported by the Member States under Article 54(2) of the Directive. As 
part  of  the  implementation  report,  Member  States  are  required  to  provide  information  of  all 
other  animals  not  reported  otherwise.  Together,  once  every  five  years,  the  annual  statistical 
report, and the information provided by the implementation report will give a comprehensive 
picture  of  all  animals  needed  to  support  research,  testing  and  education/training  needs  using 
animals in the EU in a given year:  

  annual statistical report: 

o  animals used in scientific procedures 
o  animals used for the creation and maintenance of genetically altered animal lines 

(that have experienced harm during the process) 

 

implementation report once every five years: 

o  animals bred, but not used in scientific procedures before being killed, including 

  conventional and  
 

those not reported otherwise under creation and maintenance of genetically 
altered animal lines. 

Animals  that  are  bred,  but  not  used  in  procedures  cover  all  animals  that  for  one  reason  or 
another were not  used or were unsuitable for scientific purposes.  It  is  important  to  note that 
these  numbers  include  also  those  bred  and  humanely  killed  for  the  purpose  of  providing 
organs  and  tissues,  including  to  advance  or  be  used  in  alternative  (animal  based)  methods. 
These numbers will also include many breeding animals at the end of their breeding life. 

To  ensure  that  sufficient  suitable  animals  are  available  to  meet  scientific  demand,  more 
animals are bred than used. Often, for example the age or sex of the animals will render them 
unsuitable  for  an  intended  scientific  purpose.  Other  elements  that  impact  on  the  size  of  a 
breeding stock include fecundity and gestation length. However, the most important factor is 
fluctuation  in  scientific demand. This  can apply  to  both  conventional  (row 1 in  table below) 
and genetically altered animals (row 3 in the table below). 

Some of these animals may have been used in scientific studies (for example, observation of 
behaviour)  which  did  not  cause  harm  beyond  the  minimum  threshold  as  provided  in  Article 
3(1) of the directive, as these are not classified as procedures. 

A number of ways exist aiming to reduce breeding surplus. These will be briefly discussed at 
the end of this section. 

In  reference  to  genetically  altered  animals,  unless  there  is  breeding  of  a  homozygous 
genetically  altered  line,  where  all  offspring  will  be  genetically  altered,  crossing  of 
heterozygotes will necessarily lead to some wild-type (conventional) animals being born (row 
2 and row 3). 

Row 3 also includes animals which are genetically altered, but which have suffered no harms 
as a consequence, and therefore were not reported in the annual statistical report.    

38 

 
 
Finally, these animals also include those that were intended to be used, but for example have 
fallen  ill  and  killed  humanely  before  being  used.  This  would  also  include  health  status 
breakdowns,  where  a  number  of  animals  would  need  to  be  killed  to  protect  the  health  and 
scientific integrity of the colony. 

The  total  numbers  of  animals  in  2017  for  the  three  reported  categories  in  the  EU  were  as 
follows: 

Types of animals 

Number of conventional animals bred, killed and not used in procedures  
(excluding those involved in the creation or maintenance of a genetically 
altered animal (GA) line) 

Number of genetically normal animals (wild type offspring) produced, 
bred and killed as a result of creation of a new genetically altered (GA) 
line* 

Number of animals bred and killed for the maintenance of an established 
genetically altered (GA) line 

Total number of animals bred, killed and not used in procedures and not 
covered in annual statistical reporting 

Numbers 

6,484,535 

525,085 

5,588,196 

12,597,816 

* This category includes all animals (all GA and  wild type offspring) bred and killed from both harmful and non-
harmful phenotype lines, that were not otherwise reported in the annual statistics 

The  table  below  shows  by  species  the  total  number  of  animals  bred,  killed  and  not  used  in 
procedures  including  genetically  altered  (GA)  animals  not  otherwise  reported  in  the  annual 
statistics reported by Member States, combining all the categories discussed above.  

Species 

Mice 
Zebra fish 
Rats 
Other fish 
Guinea-pigs 
Rabbits 
Domestic fowl 
Pigs 
Other rodents 
Mongolian gerbil 
Xenopus 
Rana 
Other birds 
Other carnivores 
Amphibians 
Ferrets 
Syrian Hamster 

Numbers 

10,496,190 
961,802 
557,880 
320,230 
75,590 
64,633 
35,593 
21,588 
18,842 
15,046 
10,470 
5,248 
3,631 
3,021 
2,181 
1,937 
1,355 

39 

 
 
Cattle 
Sheep 
Other mammals 
Dogs 
Marmosets and tamarins 
Rhesus monkey 
Cynomolgus monkey 
Goats 
Horses, donkeys & cross-breeds (Equidae) 
Prosimians 
Reptiles 
Cats 
Cephalopods 
Total 

1,303 
461 
346 
230 
107 
48 
32 
17 
12 
10 
7 
4 
2 
12,597,816 

Other fish includes Oryzias latipes -Japanese rice fish, Onchorynchus mykiss- Rainbow trout, 
brown  trout,  Salmo  salar  salmon,  Anguilla  anguilla  -  European  eel,  Killifish,  Oreochromis 
niloticus -tilapia, Whitefish 

Other  rodents  includes  hamsters  including  specified  species  Cricetus  cricetus  -  European 
hamster, Phodopus sungorus - Winter white dwarf hamster, Myodes  glareolus - bank vole. 

Other carnivores includes: Vulpes lagopus – Bluefox, Neovison vison – mink, badger 

Other  mammals  includes:  Reindeer,  Monodelphis  domestica  -  short  tailed  opossum, 
Laboratory opossum 

Two  Member  States  reported  no  animals  that  were  bred  and  killed  without  being  used  in 
procedures  (Bulgaria and Malta). All  other Member States reported such animals,  which are 
shown below with Member State data reported in the different reporting categories. 

Member 
State 

Conventional 
animals 

AT 

BE 

BG 

CY 

CZ 

DE 

DK 

EE 

EL 

ES 

FI 

146,925 

183,147 

0 

242 

115,058 

1,410,300 

270,081 

11,006 

10,400 

148,367 

90,554 

Creation of a 
new 
genetically 
altered 
animal line 

13,004 

9,088 

GA 
maintenance 

Total GA 
(creation and 
maintenance) 

Total per 
Member 
State 

138,277 

283,534 

997 

49,779 

2,246,000 

266,917 

11,625 

25,000 

126,052 

59,246 

151,281 

292,622 

0 

997 

57,242 

2,534,000 

278,863 

11,641 

27,800 

141,023 

60,778 

298,206 

475,769 

0 

1,239 

172,300 

3,944,300 

548,944 

22,647 

38,200 

289,390 

151,332 

7,463 

288,000 

11,946 

16 

2,800 

14,971 

1,532 

40 

 
 
 
  
  
  
FR 

HR 

HU 

IE 

IT 

LT 

LU 

LV 

MT 

NL 

PL 

PT 

RO 

SE 

SI 

SK 

UK 

Total 

1,452,168 

7,193 

50,272 

438,224 

92,981 

721 

2,679 

539 

0 

396,648 

17,708 

13,842 

1,936 

68,956 

4,855 

4,467 

61,205 

328 

6,389 

311 

4,792 

146 

32,542 

1,589 

1,000 

0 

13,463 

68 

609,996 

2,608 

36,876 

91 

53,902 

14 

7,052 

72,081 

22,075 

7,172 

40 

112,586 

1,838 

547 

671,201 

2,123,369 

2,936 

43,265 

402 

58,694 

14 

7,198 

0 

0 

104,623 

23,664 

8,172 

40 

126,049 

1,906 

547 

10,129 

93,537 

438,626 

151,675 

735 

9,877 

539 

0 

501,271 

41,372 

22,014 

1,976 

195,005 

6,761 

5,014 

1,545,266 

6,484,535 

54,432 

525,085 

1,453,891 

5,588,196 

1,508,323 

6,113,281 

3,053,589 

12,597,816 

It  is  important  that there is  good oversight  of breeding programmes to  minimize as far as is 
practicable  surplus  animals,  but  it  is  acknowledged  given  the  fluctuations  in  supply  and 
demand,  and  the  specificity  of  requirements  for  certain  studies  there  will  always  be  some 
animals which cannot be used for scientific studies.  

Other avenues for their use should be considered, for example rodents as food for raptors or 
reptiles, and farm animals being returned for agricultural use. 

Matching supply and demand of laboratory animals 

The list  below has  been developed as part of an  EU Expert Working Group focusing on the 
use of genetically altered animals. A number of the recommendations included in a draft report 
(still under preparation) are equally suitable in a conventional breeding environment. 

  Ensure that exacting specific requirements made by scientists are necessary and justified – 

use of single sex; age/weight range. 

  Efficiencies  are  generally  found  in  large  breeding  colonies  servicing  multiple  users 

(commercial breeders) or internal collaborations. 

  Effective communication over availability of, and sharing of tissues. 

  Ensure appropriate notification by scientists to colony managers of numbers required and 
when  to  allow  lead  in  times  to  studies  to  facilitate  optimum  management  of  breeding 
colonies. 

  Effective preventive and reactive disease control. 

  Consider using ex-breeding animals. 

41 

 
 
  
  
  
  
  
  
 
With respect to breeding of genetically altered animals 

  There  are  likely  to  be  animals  of  the  incorrect  genetic  make-up  which  make  them 

unsuitable for the proposed scientific use. 

  Method of generation of GA animals will influence number of animals unsuitable for 
scientific use. Efficient methodologies should be selected when available and where 
increased harms are outweighed by a significant reduction in numbers. 

C.2.ii. Sourcing of non-human primates 

Reporting obligation 

“the  sourcing  of  non-human  primates  and  how  the  requirements  of  Articles  10  and  28  of 
Directive 2010/63/EU are met” 

Background 

The  Directive  provides  in  its  Article  10  concerning  animals  bred  for  use  in  procedures  the 
following: 

“1.Member States shall ensure that animals belonging to the species listed in Annex I may 
only be used in procedures where those animals have been bred for use in procedures. 

However, from the dates set out in Annex II, Member States shall ensure that non-human 
primates  listed  therein  may  be  used  in  procedures  only  where  they  are  the  offspring  of 
non-human primates which have been bred in  captivity or where they are sourced from 
self-sustaining colonies. 

For  the  purposes  of  this  Article  a  ‘self-sustaining  colony’  means  a  colony  in  which 
animals are bred only within the colony or sourced from other colonies but not taken from 
the wild, and where the animals are kept in a way that ensures that they are accustomed 
to humans. ….. 

2. …… 

3.Competent authorities may grant exemptions from paragraph 1 on the basis of scientific 
justification.” 

In Article 28 on breeding strategy for non-human primates: 

“Member  States  shall  ensure  that  breeders  of  non-human  primates  have  a  strategy  in 
place  for  increasing  the  proportion  of  animals  that  are  the  offspring  of  non-human 
primates that have been bred in captivity.” 

Analysis 

Questions in the questionnaire  

C - 2.ii Do you have any authorised users, breeders or suppliers of non-human primates 
(NHP) in your Member State? Yes/No 

C  -  2.ii.bis  Provide  information  on  the  sourcing  of  NHP  and  how  the  requirements  of 
to 
Article  10  are  being  met.  For  example,  what  measures  have  been 
promote/require  the  use  of  F2  NHP  or  those  sourced  from  self-sustaining  colonies, 
including when sourcing from outside the EU? 

taken 

42 

 
 
C  -  2.ii.tris  Provide  information  on  strategies  in  place  to  increase  the  proportion  of 
animals of F2 (or higher) in line with Article 28 

12  Member  States  reported  that  they  had  authorised  establishments  for  the  use,  breeding 
and/or supplying no-human primates.  

The objective of the provision in Article 28 is to facilitate the move towards second or higher 
generation  purpose-bred  (F2/F2+)  breeding  of  non-human  primates  in  the  EU.  However,  on 
the basis of the implementation reports received from the Member States it can be concluded 
that this objective has already been achieved in the EU. All authorised breeding establishments 
in  the  EU  are  already  today  supplying  only  F2/F2+  animals,  confirming  the  findings  of  the 
feasibility study11 conducted under Article 10 and published in November 2017.  

To  further  the  aims  of  the  Directive  globally,  in  Member  States  where  animals  are  sourced 
from overseas, Member States are making efforts to obtain only F2/F2+ animals, and although 
not within EU jurisdiction, are encouraging overseas breeders to increase the supply of F2/F2+ 
animals available.  

C.3. Exemptions 

Reporting obligation 

“information  on  circumstances  under  which  exemptions  were  granted  in  accordance  with 
Articles  10(3),  12(1),  33(3)  of  Directive  2010/63/EU  and  in  particular  on  the  exceptional 
circumstances referred to  in  Article 16(2) of  that  Directive where a reuse of  an animal after  a 
procedure  in  which  the  actual  suffering  was  assessed  as  severe  was  authorised  during  the 
reporting period” 

It  is  important  to  note  that  no  detailed,  numerical  data  are  required  on  exemptions. 
Instead, Member States are required to provide information on the type of circumstances under 
which  such  exemptions  have  been  granted.  However,  in  some  instances  Member  States  did 
provide voluntarily numerical, more detailed data. 

Analysis 

Article 10 - Animals bred for use in procedures 

Directive provides:  

“1.  Member  States  shall  ensure  that  animals  belonging  to  the  species  listed  in  Annex  I 
may  only  be  used  in  procedures  where  those  animals  have  been  bred  for  use  in 
procedures. 

2. ….  

3.  Competent  authorities  may  grant  exemptions  from  paragraph  1  on  the  basis  of 
scientific justification.” 

Question in the questionnaire  

11 https://ec.europa.eu/environment/chemicals/lab_animals/related_topics_en.htm 

43 

 
 
 
                                                           
C  -  3.1  Provide  cumulative  information  covering  years  2013-2017  on  circumstances 
under which exemptions were granted to the requirement to use animals (listed in Annex 
I)  purpose  bred  for  scientific  use;  and/or  to  the  use  of  marmosets  that  not  of  F2/F2+ 
generation  (Article  10(3).  Please  remember  to  indicate  the  type  of  species  involved  in 
these  exemptions.  Where  possible,  provide  an  estimate  of  the  relative  frequency  of  such 
exemptions. 

During  the  reporting  period  2013-2017,  15  Member  States  reported  authorising  exemptions. 
Where  numerical  data  were  voluntarily  provided,  the  numbers  of  exemptions  varied 
significantly from one exemption in five years to more than one hundred per annum.  

The main exemptions were for work in the wild (for example using mice or rats naturally bred 
in  the  wild)  investigating  for  example  wild  populations  or  disease/zoonotic  status,  or  work 
using  pet  dogs  and  cats  in  veterinary  research  to  investigate  clinical  disease  and  novel 
treatments. Other examples included scientific need for breeds of dogs that develop naturally 
the disease of interest and which are not available from authorised breeders. Wild-caught frogs 
were also reported as having been used. 

There were no reported exemptions  given for the use of marmosets  that were not  of F2/F2+ 
generation. 

Article 12 - Procedures 

Directive provides:  

“1.Member States shall ensure that procedures are carried out in a user’s establishment. 

The competent authority may grant an exemption from the first subparagraph on the basis 
of scientific justification.” 

Question in the questionnaire 

C - 3.2 Provide cumulative information covering years 2013-2017 on circumstances (such 
as  work  on  animals  in  the  wild,  work  on  animals  in  a  commercial  farm)  under  which 
exemptions were granted to the requirement to carry out a project in user’s establishment 
(Article  12(1)).  Where  possible,  provide  an  estimate  of  the  relative  frequency  of  such 
exemptions. 

22  Member  States  authorised  exemptions  under  Article  12  to  enable  work  to  be  performed 
outside a user establishment. 

Work  in  the  wild  is  the  most  common  exemption,  used  for  investigating  animals  in  their 
natural  habitat,  for  example  behavioural,  population  or  health  studies,  although  many 
exemptions  are  also  authorised  for  research  work  under  commercial  conditions  on  farm 
animals.  Work  in  veterinary  practices  has  also  been  authorised.  Authorisations  have  been 
given  to  enable  work  in  hospitals  with  specialist  equipment  (for  example  CT  scan)  not 
available within the scientist’s own establishment. 

On the basis of additional voluntary data, the frequencies of such exemptions were estimated 
by a few Member States to be around 5% of projects. 

Article 16 - Reuse 

44 

 
 
Directive provides: 

“1. Member States shall ensure that an animal already used in one or more procedures, 
when  a  different  animal  on  which  no  procedure  has  previously  been  carried  out  could 
also  be  used,  may  only  be  reused  in  a  new  procedure  provided  that  the  following 
conditions are met:  

a)  the actual severity of the previous procedures was ‘mild’ or ‘moderate’;  
b)  it  is  demonstrated  that  the  animal’s  general  state  of  health  and  well-being  has 

been fully restored;  

c)  the further procedure is classified as ‘mild’, ‘moderate’ or ‘non-recovery’; and  
d)  it  is  in  accordance  with  veterinary  advice,  taking  into  account  the  lifetime 

experience of the animal.  

2. In exceptional circumstances, by way of derogation from point (a) of paragraph 1 and 
after a veterinary examination of the animal, the competent authority may allow reuse of 
an  animal,  provided  the  animal  has  not  been  used  more  than  once  in  a  procedure 
entailing severe pain, distress or equivalent suffering. 

Question in the questionnaire 

C  -  3.3  Provide  cumulative  information  covering  years  2013-2017  on  the  exceptional 
circumstances  under  which  exemptions  were  granted  for  the  reuse  of  an  animal  after  a 
procedure  in  which  the  actual  suffering  was  assessed  as  severe  (Article  16(2)).  Please 
remember  to  indicate  the  type  of  species  involved  in  these  exemptions.  Where  possible, 
provide an estimate of the relative frequency of such exemptions. 

Two  Member  States  stated  that  they  have  disallowed  this  option  under  their  national 
legislation. 

Only France reported that some derogation was permitted in certain projects without providing 
further information on the specific circumstances. 

Article 33 - Care and accommodation 

Directive provides: 

“1. Member States shall, as far as the care and accommodation of animals is concerned, 
ensure that:  

a)  all  animals  are  provided  with  accommodation,  an  environment,  food,  water  and 

care which are appropriate to their health and well-being;  

b)  any restrictions on the extent to which an animal can satisfy its physiological and 

ethological needs are kept to a minimum;  

c)  the environmental conditions in which animals are bred, kept or used are checked 

daily;  

d)  arrangements  are  made  to  ensure  that  any  defect  or  avoidable  pain,  suffering, 
distress or lasting harm discovered is eliminated as quickly as possible; and  

e)  animals are transported under appropriate conditions.  

2.  For  the  purposes  of  paragraph  1,  Member  States  shall  ensure  that  the  care  and 
accommodation  standards  set  out  in  Annex  III  are  applied  from  the  dates  provided  for 
therein. 

45 

 
 
3.Member  States  may  allow  exemptions  from  the  requirements  of  paragraph  1(a)  or 
paragraph 2 for scientific, animal-welfare or animal-health reasons.” 

Question in the questionnaire 

C  -  3.4  Provide  cumulative  information  covering  years  2013-2017  on  circumstances 
(reasons) under which exemptions (such as for single housing, restriction of food/water, 
restriction on enclosure sizes) were granted to the care and accommodation requirements 
(Article  33(3)).  Please  remember  to  indicate  the  type  of  species  involved  in  these 
exemptions.  Where  possible,  provide  an  estimate  of  the  relative  frequency  of  such 
exemptions. 

18 Member States reported that exemptions were authorised from the care and accommodation 
standards. A number of responses merely indicated that exemptions had been given, whereas 
others  provided  detailed  information  on  the  reasons  for  such  exemptions.  A  few  Member 
States voluntarily provided numerical data. 

The circumstances for exemptions included: 

  Use of metabolic cages, whose dimensions were below those set out in Annex III 

was a common reason for exemption; 

  Use  of  “commercial  stocking  densities”  during  certain  research  studies  in 
agricultural  animals  into  for  example  behaviour,  mechanisms  of  spread  of 
infectious disease; 

  Single  housing  for  scientific  reasons,  for  example  to  measure  behavioural 

responses to stimuli, food intake; 

  Food / water control as a motivational tool in training animals to perform novel or 

learned tasks required for a research protocol; 

  Disruption to “normal” environment and group housing as behavioural stressors; 
  Feeding altered diets to investigate for example mineral deficiencies.   

It is perhaps surprising, given the scale and breadth of exemptions for variations in the housing 
and care requirements to enable scientific projects to proceed, that 10 Member States had not 
reported any requests for exemptions from these requirements. 

C.4. Animal Welfare Body (Articles 26 and 27 of Directive 2010/63/EU)  

Reporting obligation 

“information on the structure and functioning of animal welfare bodies” 

Background: 

The Directive states in its Articles 26 and 27 the following: 

“Article 26 Animal-welfare body  

1.  Member  States  shall  ensure  that  each  breeder,  supplier  and  user  sets  up  an 

animal-welfare body.  

2.  The animal-welfare body shall include at least the person or persons responsible 
for  the  welfare  and  care  of  the  animals  and,  in  the  case  of  a  user,  a  scientific 

46 

 
 
member.  The  animal-  welfare  body  shall  also  receive  input  from  the  designated 
veterinarian or the expert referred to in Article 25.  

3.  Member  States  may  allow  small  breeders,  suppliers  and  users  to  fulfil  the  tasks 

laid down in Article 27(1) by other means.  

Article 27 Tasks of the animal-welfare body  

1.  The animal-welfare body shall, as a minimum, carry out the following tasks:  

a.  advise the staff  dealing  with animals on matters related to  the welfare of 
animals, in relation to their acquisition, accommodation, care and use;  
b.  advise  the  staff  on  the  application  of  the  requirement  of  replacement, 
reduction and refinement, and keep it informed of technical and scientific 
developments concerning the application of that requirement;  

c.  establish and review internal operational processes as regards monitoring, 
reporting  and  follow-up  in  relation  to  the  welfare  of  animals  housed  or 
used in the establishment;  

d.  follow  the  development  and  outcome  of  projects,  taking  into  account  the 
effect  on  the  animals  used,  and  identify  and  advise  as  regards  elements 
that further contribute to replacement, reduction and refinement; and  
e.  advise on rehoming schemes, including the appropriate socialisation of the 

animals to be rehomed.  

2.  Member  States  shall  ensure  that  the  records  of  any  advice  given  by  the  animal-
welfare  body  and  decisions  taken  regarding  that  advice  are  kept  for  at  least  3 
years.  

The records shall be made available to the competent authority upon request.” 

Analysis 

The inclusion of the requirement to have Animal Welfare Bodies in every establishment has 
been  recognised  as  a  very  positive  step  to  improve  welfare  and  science.  Their  inputs  at 
establishments have raised awareness of the importance of the application of the Three Rs for 
all animals, whether being used, bred or held in stock. Animal Welfare Bodies have improved 
communication between those conducting procedures and those caring for the animals. 

Questions in the questionnaire  

C - 4.1 Provide general  information on the structure and functioning of  animal  welfare 
bodies 

C - 4.2 In describing the structure of animal welfare bodies, does your MS require other 
persons to be permanent members beyond those listed in Article 26(2)? 

C - 4.2.bis Please provide a description of the other persons required to be members of 
animal welfare bodies 

C  -  4.3  Does  your  MS  allow  achieving  the  tasks  in  Article  27(1)  by  other  means  than 
through establishment of an animal welfare body? 

47 

 
 
 
C  -  4.3.bis  Please  describe  what  other  means  are  used  to  achieve  the  tasks  in  Article 
27(1).  Where  possible,  please  include  the  definition  for  a "small"  breeder,  users  and/or 
supplier 

Structure and functioning of Animal Welfare Bodies 

Many Member States reported that the composition of Animal Welfare Bodies is broader than 
the minimum set out in the Directive. Almost one-third of the Member States have mandated 
additional  members  in  their  national  legislation,  and  others  have  encouraged  a  wider 
membership  in  administrative/guidance  documents.  The  common  mandated  addition  is 
inclusion  of  the  Designated  Veterinarian,  although  the  addition  of  lay  persons  has  been 
included  by  a  few,  as  well  as  in  one  Member  State  a  requirement  for  an  ethologist  for 
establishments using non-human primates.   

There was general agreement that the composition is dictated by the size and complexity of the 
establishment.    In  large  establishments,  the  frequency  of  meetings  was  higher  (up  to  once  a 
month), and in some, the functions were divided up into sub-groups, to ensure all tasks were 
covered efficiently and effectively. 

The Directive gives the option in small establishments for the tasks of Animal Welfare Bodies 
to  be  fulfilled  by  other  means.  Just  under  half  of  Member  States  include  this  option in  their 
national legislation. In practice, however, this option is not used commonly, and where it does 
occur  often  a  number  of  small  establishments  pool  resources  into  a  single  animal  welfare 
forum. A further alternative strategy has been to require the “small” establishment fulfil all the 
functions  of  the  Animal  Welfare  Body,  and  secure  external  input,  as  necessary,  to  ensure 
compliance.  No  Member  States  provided  information  on  the  criteria  used  for  defining  a 
"small" breeder, user and/or supplier. 

Additional tasks  

In a number of Member States, the Animal Welfare Body  has been  given additional tasks  – 
generally relating to the oversight of project applications, ranging from providing local advice 
and  input  to  applications,  to  full  project  evaluation,  and  reviewing  reports  of  retrospective 
assessment, as, or before submitting to, the competent authority. Where this is happening, the 
composition of the Animal Welfare Body is amended to include as necessary other members 
to ensure the necessary expertise for project evaluation. 

Some Member States have explicitly mentioned advice to manage surplus animals as  part of 
their Three Rs remit. Other additional tasks include approval and co-ordination of training of 
scientific and care staff. 

Question in the questionnaire [voluntary question] 

* C - 4.4 If possible, based on experience obtained through inspections and through the 
work  of  the  National  Committee  that  shares  best  practice  and  interacts  with  animal 
welfare bodies, what aspects of the work of animal welfare bodies function well - please 
provide examples if possible? 

48 

 
 
General view is that the majority of Animal Welfare Bodies are working well. Animal Welfare 
Bodies have improved openness and communication internally and externally on animal use; 
they encourage all to raise concerns, for example through the use of an anonymous mailbox. 

Other reported benefits include: 

improved discussions on animal use before procedures begin; 

 
  advising on resources required to maintain high standards of welfare and care; 
 

improved understanding/oversight of procedures enabling prompt interventions as 
necessary, open dialogue on problems occurring; 
  development and championing a culture of care; 
  conditions  of  accommodation  and  care  have  improved  –  better  knowledge; 

 

application of enrichment programmes; 
improved  education  and  training,  and  continued  professional  development 
opportunities; 

  networking with other Animal Welfare Bodies to share experiences and promote 

the Three Rs; 

  symposia/lectures  on  welfare  and  the  Three  Rs  –  either  at  local,  regional  or 

national level. 

In some cases, Animal Welfare Bodies also consider scientific research on animals beyond the 
scope of the Directive (such as observation studies, or studies using species not falling within 
the scope of the Directive). Some also consider the appropriateness of scientific research using 
animals conducted by scientists from the establishment while working overseas. 

Question in the questionnaire [voluntary question] 

*  C  -  4.5  If  possible,  based  on  experience  obtained  through  inspection and  through  the 
work  of  the  National  Committee  that  shares  best  practice  and  interacts  with  animal 
welfare  bodies,  what  aspects  of  the  work  of  animal  welfare  bodies  could  be  improved  - 
please provide examples if possible. 

Animal  Welfare  Bodies  vary  in  their  functioning,  with  some  taking  a  lead  role  in  the 
establishment, in promoting the Three Rs and a culture of care, with others more reactive to 
animal welfare issues and deal with adverse events as they arise. 

There are still areas regarding communication that could be improved such as between 

  Animal Welfare Bodies and some scientists: including a need for some awareness 
raising among scientific staff over the role and benefits of Animal Welfare Body; 
  committees tasked with project evaluation and Animal Welfare Bodies - including 

clearer lines of responsibilities; minimising duplication of effort. 

the 

establishment  perspective 

From 
input 
(availability/costs), as well as other resources need to be assured. This also includes sufficient 
time and reward/acknowledgement for those involved, and empowerment of Animal Welfare 
Body within the establishment to ensure recommendations are accepted and implemented. 

sufficient  veterinary 

expertise 

and 

Local input to project applications could be improved to streamline and make more efficient 
the project evaluation/authorisation process. Other elements indicated include the need to: 

49 

 
 
 

 
 

improve  access  to  and  dissemination  of  information  on  Three  Rs,  especially  on 
replacement; 
further develop networks of communication among Animal Welfare Bodies and  
further development in openness and culture of care. 

Other initiatives 

In a few Member States direct communication channels among Animal Welfare Bodies have 
been developed either at national or regional level. 

It  was  also  reported  that  an  informal  trans-national  network  of  Animal  Welfare  Bodies  has 
been developed. 

D. PRINCIPLES OF REPLACEMENT, REDUCTION AND REFINEMENT 

D.1.  Principle  of  replacement,  reduction  and  refinement  (Articles  4  and  13  of  Directive 
2010/63/EU) 

Reporting obligation  

“the  general  measures  taken  to  ensure  that  the  principle  of  replacement,  reduction  and 
refinement  is  satisfactorily addressed within  authorised projects  as well as during housing and 
care also in breeding and supplying establishments” 

Background 

Directive provides in its Articles 4 and 13 the following: 

“Article 4 

Principle of replacement, reduction and refinement 

1. Member States shall ensure that, wherever possible, a scientifically satisfactory method 
or  testing  strategy,  not  entailing  the  use  of  live  animals,  shall  be  used  instead  of  a 
procedure. 

2. Member States shall ensure that the number of animals used in projects is reduced to a 
minimum without compromising the objectives of the project. 

3. Member States shall ensure refinement of breeding, accommodation and care, and of 
methods used in procedures, eliminating or reducing to the minimum any possible pain, 
suffering, distress or lasting harm to the animals. 

4. This Article shall, in the choice of methods, be implemented in accordance with Article 
13.” 

“Article 13 

Choice of methods 

1.Without prejudice to national legislation prohibiting certain types of methods, Member 
States  shall  ensure  that  a  procedure  is  not  carried  out  if  another  method  or  testing 
strategy  for  obtaining  the  result  sought,  not  entailing  the  use  of  a  live  animal,  is 
recognised under the legislation of the Union. 

50 

 
 
2. In choosing between procedures, those which to the greatest extent meet the following 
requirements shall be selected: 

(a) use the minimum number of animals; 

(b) involve animals with the lowest capacity to experience pain, suffering, distress 
or lasting harm; 

(c) cause the least pain, suffering, distress or lasting harm; 

and are most likely to provide satisfactory results. 

3. Death as the end-point of a procedure shall be avoided as far as possible and replaced 
by  early  and  humane  end-points.  Where  death  as  the  end-point  is  unavoidable,  the 
procedure shall be designed so as to: 

(a) result in the deaths of as few animals as possible; and 

(b)  reduce  the  duration  and  intensity  of  suffering  to  the  animal  to  the  minimum 
possible and, as far as possible, ensure a painless death.”  

Analysis 

15  Member  States  have  voluntarily  uploaded  information  to  the  EC  website12  on  their 
activities in relation to the development, validation and promotion of alternative approaches at 
national level. 

Key Points from Member State responses included 

  Project application forms have specific sections on the Three Rs. 
 

In  some  Member  States,  Animal  Welfare  Bodies  advise  the  project  applicant  on 
relevant Three Rs issues. 

  Some Member States obligate literature  reviews  and searches on the Three Rs to  be 

included with application. 

  One Member State requires screenshots of searches to be included in application form. 
  Experts  challenge  on  the  Three  Rs  during  evaluation  process,  and  confirm  that 

application is compliant with the Three Rs. 

  Three Rs are subject to continuous review and update during the course of the project. 

Animal Welfare Body provide input and update on the Three Rs. 

  Compliance with the Three Rs is checked as part of the inspection process. 

Questions in the questionnaire 

D  -  1.1  Provide  information  on  general  measures  taken  to  ensure  that  the  principle  of 
Replacement,  Reduction  and  Refinement  is  satisfactorily  addressed  within  authorised 
projects.  

D  -  1.2  Provide  information  on  general  measures  taken  to  ensure  that  the  principle  of 
Replacement,  Reduction  and  Refinement  is  satisfactorily  addressed  during  housing  and 
care including in breeding and supplying establishments. 

12 https://ec.europa.eu/environment/chemicals/lab_animals/3r/advance_en.htm   

51 

 
 
 
                                                           
Please  note  that  the  voluntary  Article  47  report  covers  development,  validation  and 
promotion  of  alternative  approaches,  and  dissemination  of  information  thereon  at 
national level with no specific focus on operational application of the Three Rs 

Key Points from Member State responses cover 

  Major  benefits  with  introduction  of  Animal  Welfare  Bodies,  whose  remit  covers 
accommodation and care, and implementation  of the Three Rs for all animals in  the 
establishment. 

the 

 
 
 

throughout 

standardised  practices 

  Animal  Welfare  Bodies 

implement 
establishment – for example improved, standardised handling practices. 
Importance of ensuring Animal Welfare Bodies are supported and effective.  
Increased input of care staff to refinement opportunities. 
Improved  communication  and  dissemination  of  information  by  information  person/ 
Animal Welfare Body.  
Input from Designated Veterinarian 
Inspections and advice on the Three Rs from Inspectors 

 
 
  The  compliance  with  application  of  the  law  as  regards  applying  the  Three  Rs  is 
checked during inspections in some Member States and this appears to be another key 
measure to ensure the Three Rs are applied 
In project applications, the applicant must describe the housing and care arrangements 
for the animals to be enrolled on the project - this should include social housing plus 
environmental enrichment, as well as monitoring of health and welfare. 

 

  Environmental and social enrichment for the animals, as appropriate for the species. 
  Training and ongoing continuous training of care staff. 
  Some  Member  States  have  programmes  of  education  and  training  of  personnel 

 

(meetings/workshops/training days) including dissemination of experiences. 
In  some  Member  States  the  National  Committee  has  been  active  at  improving 
communication between Animal Welfare Bodies and communicating information  on 
Three Rs. 

  Oversight of breeding practices to minimise surplus, to match supply and demand. 
  Strategies in place to use surplus animals for organs and tissues.  
  Use of refined methodologies in re-derivation programmes.  

Question in the questionnaire [voluntary question] 

* D - 1.3 Has the EU Guidance on Severity Assessment Framework been made available 
to establishments, project evaluators and inspectors? Yes/No 

EU Guidance made available 

Yes 
No 
(blank) 
Total 

26 
1 
1 
28 

Question in the questionnaire [voluntary question] 

52 

 
 
 
*  D  -  1.4  Has  additional  official  guidance  on  Replacement,  Refinement  and  Reduction 
been developed to facilitate implementation? Yes/No 

Additional guidance developed 

Yes 
No 
(blank) 
Total 

7 
17 
4 
28 

Question in the questionnaire [voluntary question] 

* D - 1.4.bis If you consider this guidance helpful for other Member States to facilitate the 
implementation  of  the  Directive,  please  provide  web-address  for  the  guidance,  where 
available 

Provided links to websites are available in the detailed Member State summaries. 

D.2. Avoidance of duplication (Article 46 of Directive 2010/63/EU) 

Reporting obligation 

“general description of measures taken to ensure that there is no duplication of procedures” 

Background 

Directive provides in its Articles 4 and 13 the following: 

“Article 4 

Principle of replacement, reduction and refinement 

1. Member States shall ensure that, wherever possible, a scientifically satisfactory method 
or  testing  strategy,  not  entailing  the  use  of  live  animals,  shall  be  used  instead  of  a 
procedure. 

2. Member States shall ensure that the number of animals used in projects is reduced to a 
minimum without compromising the objectives of the project. 

3. Member States shall ensure refinement of breeding, accommodation and care, and of 
methods used in procedures, eliminating or reducing to the minimum any possible pain, 
suffering, distress or lasting harm to the animals. 

4.This Article shall, in the choice of methods, be implemented in accordance with Article 
13.” 

Analysis 

Question in the questionnaire 

D – 2 Provide general description of measures taken to ensure that there is no duplication 
of procedures 

Many  Member  States  ask  for  information  on  database  searches  /  declaration  in  project 
application to provide reassurances that no unnecessary duplication of procedures will occur. 

53 

 
 
 
Some  competent  authorities  request  a  minimum number  of  references  indicating  the  date  on 
which the query was made and the key word(s) used in the search 

Project  evaluation  process  includes  checks  on  information  provided.  If  similar/related 
procedures found, additional enquiries made and justification required.  

The  responses  also  encouraged  publication  of  studies  with  negative  results  to  help  avoid 
duplication. 

Publication  of  non-technical  project  summaries  may  assist  in  preventing  duplication  of 
procedures. 

D.3.  Tissue  sampling  of  genetically  altered  animals  (Articles  4,  30  and  38  of  Directive 
2010/63/EU 

Reporting obligation  

“representative information on approximate numbers, species, types of methods and their related 
severities  of  tissue  sampling  for  the  purposes  of  genetic  characterisation  carried  out  with  and 
without project authorisation covering the calendar year prior to that in which the 5-year report 
is submitted, and on efforts made to refine those methods” 

Background: 

Directive provides in its Articles 4 and 13 the following: 

 “Article 4 

Principle of replacement, reduction and refinement 

1. Member States shall ensure that, wherever possible, a scientifically satisfactory method 
or  testing  strategy,  not  entailing  the  use  of  live  animals,  shall  be  used  instead  of  a 
procedure. 

2. Member States shall ensure that the number of animals used in projects is reduced to a 
minimum without compromising the objectives of the project. 

3. Member States shall ensure refinement of breeding, accommodation and care, and of 
methods used in procedures, eliminating or reducing to the minimum any possible pain, 
suffering, distress or lasting harm to the animals. 

4. This Article shall, in the choice of methods, be implemented in accordance with Article 
13.” 

Analysis 

Question in the questionnaire 

D - 3.1 Are genetically altered animals/animal lines (non-harmful and/or harmful 
phenotype) being created, bred and/or used in your MS? Yes/No 

26  Member  States  reported  that  genetically  altered  animals/animal  lines  were  being  created, 
bred and/or used in their Member States. Bulgaria and Malta stated that no genetically altered 
animals are created/bred and/or used in their Member State. 

54 

 
 
 
 
Questions in the questionnaire 

D - 3.2 Provide representative information on approximate numbers, species, types of 
methods and their related severities of tissue sampling for the purposes of genetic 
characterisation carried out with and without project authorisation. 

D - 3.4 Please indicate the criteria for sampling to obtain representative information 
above (for example as a proportion of all establishments breeding GA animals and the 
period during which the sample was taken) 

It  is  important  to  note  in  this  context  that  the  Member  States  were  required  to  only  provide 
representative  information  on  methods  used  for  tissue  sampling.  Therefore,  the  provided 
figures  are  not  comparable  between  Member  States,  as  the  basis  on  which  the  sample  has 
been  given  varies  from  one  Member  State  to  another.  Nine  Member  States  sampled  all 
establishments  over  a  whole  year,  two  sampled  all  establishments  over  six  months,  others 
indicated  a  variety  of  differing  systems,  and  no  sampling  information  were  provided  from  a 
few.  

The  purpose  of  the  data  was  to  understand  the  relative  distribution  of  different  types  of 
methods and the related severities of methods authorised within projects. 

However,  it  is  not  possible  to  provide  quantitative  EU  level  summary  on  the  basis  of  the 
Member State data submissions. The information requirements were not understood correctly 
by  all  Member  States,  possibly  partly  due  to  insufficient  precision  in  the  formulation  of  the 
question.  As  a  result,  the  data  either  lacked  the  related  sub-categorisation,  or  provided  an 
indication of sub-categories but without detailing the numbers or species involved in each. For 
example, tail biopsy and ear biopsy were included in the same entry, thus it was impossible to 
separate the numbers for each method. 

Information was provided on sampling methods for around 5.9 million animals, 97% of these 
being mice, with fish accounting for 2%. 

As the quality of the information varied so significantly, further analysis was carried out only 
on the data provided on mouse tissue sampling methods. 

Data  from  only  around  2 million  animals  (34%) of the total  data submitted on mouse tissue 
sampling  methods  contained  in  the  Member  State  reports  could  be  used  for  further  analysis 
and conclusions. 

Qualitative analysis of the data that could be interpreted shows that, for mice, tail biopsy, ear 
biopsy  and  removal  of  part  or  all  of  a  digit  remain  the  most  commonly  used  methods  to 
provide tissue for genotyping in the EU, despite some more refined alternatives being used by 
some,  such  as  hair  bulb  or  observation  under  special  lighting  conditions.  In  some  cases, 
genotyping can be performed post mortem, which does not increase the welfare impact on the 
animals. 

Acquisition of surplus tissue from methods of identification accounted for just over half of all 
the  mice  sampled  –  of  these  methods  ear  punch/biopsy  accounted  for  89%,  distal  phalanx 
biopsy 10.9% - although it was reported in a few cases that surplus tissue from tail sampling is 
used for identification, tail sampling rarely can be used to identify animals: it provides only a 
binomial marking system – normal length tail or short tail. 

55 

 
 
If  surplus  tissue  from  an  identification  method  can  be  used,  then  this  is  fully  refined  as  no 
other  technique  need  be  applied.  On  the  basis  of  the  data  that  could  be  used  for  analysis, 
surplus tissue from 87% of ear marks form the biopsy tissue for genotyping. This falls to 59% 
for (partial) digit removal. 

Blood sampling, skin sampling and post-mortem sampling are also unlikely to permit animal 
identification, and these submissions may be in error. 

With regard to methods of tissue sampling under project authorisation, tail biopsy is the most 
commonly used (65%), followed by ear biopsy (20%), distal phalanx biopsy (13%) and blood 
sampling (2%). 

Even for these common techniques, there is variability in the reporting of severity. This may 
be because of other techniques applied (including analgesia/anaesthesia) or phenotype effects 
of the genetic mutation. However, it may reflect inconsistencies in the reporting of the same 
technique. 

The  use  of  sampling  methodologies  considered  non-invasive,  not  requiring  a  project 
authorisation  accounted  for  less  than  2%  of  all  sampling,  with  use  of  post-mortem  material 
accounting for the majority in this category, with a few using observation, exposure to specific 
lighting conditions or hair sampling.  

Question in the questionnaire 

D - 3.3 Provide information on efforts being made to refine tissue sampling techniques for 
genotyping 

The  replacement  of  tail  biopsy  by  taking  surplus  tissue  from  identification  is  occurring  in 
many Member States.  

Other methods to reduce and refine the effects on the animal include avoidance of the need for 
tissue sampling/genotyping by use of particular breeding strategies, for example homozygous 
x homozygous, genotyping post mortem, tissue taken is as small as possible, reliable analysis 
methods  which  remove  the  need  for  second  testing  /  sampling,  saving  part  of  tissue  in  case 
resample  is  required,  tail  /  toe  biopsy  technique  is  performed  before  ossification  and 
innervation  is  advanced  (young  animals),  use  of  local  and/or  general  anaesthesia,  use  of 
analgesia,  use  of  fluorescent  markers  (non-invasive).  Size  of  sample  required  is  now  much 
reduced due to the accuracy of analytical method. 

For zebrafish rapid  analyses reduces  the time that  fish must be kept  single housed to  one to 
two  days,  and  genotyping  of  larvae  means  that  surplus  animals  can  be  removed  before 
independent feeding.  

It  is  important  that  the  obligation  to  refine  tissue  sampling  methods,  where  possible,  is 
systematically addressed to  ensure uptake of more refined methods and compliance with  the 
Directive. There are non-invasive methods becoming available and these should be taken up 
where  technically  possible.  When  invasive  methods  are  used  for  identification,  these  should 
provide surplus tissue for genotyping. In the light of the  fact that tail biopsy, ear biopsy and 
removal of part or all of a digit remain the most commonly used methods in EU, inspections 

56 

 
 
 
should  systematically  address  whether  the  most  refined  methods  of  identification  and  tissue 
sampling are being used. Since tail biopsy does not allow identification, it is unlikely that this 
method will be the most refined.  

Question in the questionnaire [voluntary question] 

* D - 3.5 Has the Working Document on Genetically Altered animals been made available 
to establishments housing or using genetically altered animals? Yes/No 

EU Guidance made available 

Yes 
No 
n/a 
(blank) 
Total 

20 

2 
6 
28 

22 Member States answered this voluntary question. Of these, 20 Member States have made 
this available, and the two answering n/a do not use genetically altered animals.   

Question in the questionnaire [voluntary question] 

* D - 3.6 Has additional official guidance on genetically altered animals been developed 
to facilitate implementation?  

* D - 3.6.bis If you consider this guidance helpful for other Member States to facilitate the 
implementation  of  the  Directive,  please  provide  web-address  for  the  guidance,  where 
available 

Additional guidance developed 

Yes 
No 
n/a 
(blank) 
Total 

4 
16 
2 
6 
28 

Four Member States have created additional guidance and websites have been provided in the 
detailed Member State summaries. 

E. ENFORCEMENT 

E.1.  Authorisation  of  breeders,  suppliers  and  users  (Articles  20  and  21  of  Directive 
2010/63/EU) 

Reporting obligation 

“number  of  active  authorised  breeders,  suppliers  and  users;  information  on  suspensions  or 
withdrawals of authorisations of breeders, suppliers and users and the reasons therefore” 

Background 

57 

 
 
 
 
 
Directive provides in its Articles 20 and 21 the following: 

“Article 20 

Authorisation of breeders, suppliers and users 

1. Member States shall ensure that all breeders, suppliers and users are authorised by, 
and registered with, the competent authority. Such authorisation may be granted for a 
limited period. 

Authorisation shall be granted only if the breeder, supplier or user and its establishment 
is in compliance with the requirements of this Directive. 

2. The authorisation shall specify the person responsible for ensuring compliance with the 
provisions of this Directive and the person or persons referred to in Article 24(1) and in 
Article 25. 

3. Renewal of the authorisation shall be required for any significant change to the 
structure or the function of an establishment of a breeder, supplier or user that could 
negatively affect animal welfare. 

4. Member States shall ensure that the competent authority is notified of any changes of 
the person or persons referred to in paragraph 2. 

Article 21 

Suspension and withdrawal of authorisation 

1. Where a breeder, supplier or user no longer complies with the requirements set out in 
this Directive, the competent authority shall take appropriate remedial action, or require 
such action to be taken, or suspend or withdraw its authorisation. 

2. Member States shall ensure that, where the authorisation is suspended or withdrawn, 
the welfare of the animals housed in the establishment is not adversely affected." 

Analysis 

Questions in the questionnaire  

E - 1.1 Provide number of active authorised breeders, suppliers and users. The numbers 
in  this  table  indicate  the  total  number  of  active  establishments  authorised  and  having 
bred, used and/or supplied animals in the reporting year (not only those newly authorised 
in a given year) 

* E - 1.2 Provide number of active establishments keeping non-human primates  

[voluntary  question  –  requested  for  the  purposes  of  assessing  compliance  with 
requirements for inspections under section E-2] 

It is important to note in this context that the lower numbers during the first years reflect the 
fact that the Directive obligations had yet to be transposed in the national legislation in some 
Member States. The last Member State adopted national legislation only in the spring of 2015. 

58 

 
 
 
 
Not all Member States gave complete data for all columns, and some only the total numbers of 
breeders, suppliers and users combined.  

Only half of the Member States using non-human primates answered the voluntary question on 
establishments housing non-human primates. 

59 

 
 
 
 
 
 
Total number of active breeders, suppliers and users authorised in the EU 

Year 

1. Number of 
active breeding 
establishments 
(not using 
animals) 

2. Number of 
active 
establishments 
authorised 
only to supply 
animals bred 
by  others (not 
breeding 
/using animals) 

2013 

2014 

2015 

2016 

2017 

115 

180 

255 

257 

258 

36 

40 

49 

51 

50 

3. Number of 
active 
establishments 
authorised to 
breed  both 
and supply 
their own and 
those bred by 
others (not 
using animals) 
84 

97 

106 

104 

106 

4. Total 
number of 
breeders 
and/or 
suppliers (from 
columns 1 to 
3) 

5. Number of 
active 
establishments 
authorised to 
only use 
animals 

6. Number of 
active 
establishments 
authorised to 
use and breed 
animals 

7. Number of 
active 
establishments 
authorised to 
use and supply 
animal 

8. Number of 
active 
establishments 
authorised to 
use, breed and 
supply animals 

9. Total 
number of 
active 
establishments 
authorised to 
use animals 
(the total of 
columns 5 to 
8) 

696 

945 

1,044 

1,011 

1,093 

1,348 

1,354 

1,405 

1,354 

1,338 

251 

1,035 

1,141 

1,156 

1,197 

6 

7 

7 

10 

10 

176 

205 

211 

220 

216 

1,781 

2,602 

2,772 

2,748 

2,769 

Total number of authorised breeders, suppliers and 
users in the EU (from columns 4 and 9) 

2013 
2014 
2015 
2016 
2017 

2,477 
3,547 
3,816 
3,759 
3,862 

60 

 
 
 
 
 
 
Member State comparison of active authorised breeders, suppliers and users.  

Total number of active authorised establishments  
by year (2013-2017) for each MS 

900

800

700

600

500

400

300

200

100

0

2013 

2014 

2015 

2016 

2017 

AT

BE

BG

CY

CZ

DE

DK

EL

ES

EE

FI

FR

HR

HU

IE

IT

LT

LU

LV MT

NL

PL

PT

RO

SK

SI

SE

UK

61 

 
 
 
 
Withdrawals of breeders, suppliers and users 

Question in the questionnaire  

E - 1.3 Provide cumulative information covering years 2013-2017 on the suspensions or 
withdrawals of authorisation of breeders, suppliers and users and reasons thereof 

21  Member  States  reported  that  no  authorisations  for  breeders,  suppliers  or  users  had  been 
withdrawn during the reporting period as a consequence of enforcement action. 

A few reported that establishments had closed during this period but for reasons unrelated to 
compliance, such as lack of funding or loss of expertise. One Member States reported that a 
number of establishments closed due to their inability to meet the new requirements in Annex 
III on housing and care practices. 

Two Member States reported that authorisations had been removed. In one Member State, one 
user was closed in 2014, one in 2016 and one in 2017, but no reasons were provided. In the 
other Member State, three authorisations were withdrawn, one due to water damage, one for 
failing to meet building requirements, and one where no application was received to continue.  

Five Member States did not provide any information in response to this question.  

E.2. Inspections (Article 34 of Directive 2010/63/EU) 

Reporting obligation 

“quantitative  and  qualitative  operational  information  including  criteria  applied  under  Article 
34(2)  of  Directive  2010/63/EU  and  proportion  of  unannounced  inspections  broken  down  by 
year” 

Background 

Directive provides in its Articles 4 and 13 the following: 

“1.  Member  States  shall  ensure  that  the  competent  authorities  carry  out  regular 
inspections of all breeders, suppliers and users, including their establishments, to verify 
compliance with the requirements of this Directive.  

2. The competent authority shall adapt the frequency of inspections on the basis of a risk 
analysis for each establishment, taking account of:  

(a) the number and species of animals housed;  

(b) the record of the breeder, supplier or user in complying with the requirements 
of this Directive;  

(c) the number and types of projects carried out by the user in question; and  

(d) any information that might indicate non-compliance.  

3.  Inspections  shall  be  carried  out  on  at  least  one  third  of  the  users  each  year  in 
accordance  with  the  risk  analysis  referred  to  in  paragraph  2.  However,  breeders, 
suppliers and users of non- human primates shall be inspected at least once a year.  

4.  An  appropriate  proportion  of  the  inspections  shall  be  carried  out  without  prior 
warning.  

62 

 
 
5. Records of all inspections shall be kept for at least 5 years.” 

Analysis 

Questions in the questionnaire  

E  -  2.1  Is  the  endorsed  EU  Inspection  Risk  Analysis  Criteria  used  as  the  basis  for  risk 
assessment? Yes/No 

E - 2.1.bis Please provide the criteria used for risk analysis in your MS (including web-
address where the criteria can be found) 

24 Member States confirmed using EU Inspection Risk Analysis Criteria as the basis for risk 
assessment. Three Member States gave other local criteria similar to the EU document, or with 
one stating that the system was in development. 

Several Member States made comment in other sections about the risk drivers for inspection 
including  outcomes  of  previous  inspections  of  the  establishment;  types  of  animals  held 
especially  use  of  special  species,  the  number  of  animals  kept  and  used,  relating  to  that  the 
severity,  duration  and  frequency  of  the  procedures  carried  out  influence  the  inspection 
programme.  Identification  of  any  deficiencies,  particularly  if  there  is  apparent  resistance  to 
change  or  any  unwillingness  to  provide  information  requested  are  significant  drivers  for 
increased inspections. 

Questions in the questionnaire  

E - 2.2 Are all new establishments inspected before an authorisation is granted? Yes/No 

E - 2.2.bis Provide description on how the compliance with the provisions of the Directive 
is ensured as required in the second paragraph of Article 20(1) 

27 Member States  confirmed inspection of an establishment being necessary before granting 
an  authorisation.  Austria  stated  that  in  most  cases  this  includes  an  on-site  visit  before 
authorisation  is  granted  but  not  all  new  establishments  were  inspected  before  granting  an 
authorisation. 

Questions in the questionnaire  

E - 2.3 Provide quantitative operational information on inspections including proportion 
of unannounced inspections broken down by reporting year 

E  -  2.4  Provide  qualitative  operational  information  on  inspections  carried  out  under 
Article  34.  Qualitative  operational  information  includes  e.g.  effectiveness  in  terms  of 
impacts  (such  as  declining  trend  in  non-compliance);  changes  in  risk  profile  of 
establishments;  reduction  in legal  and  administrative  actions  due  to  infringements. 
Explain unusual or outlying figures – in particular, if not meeting minimum requirements, 
make clear the actions being taken to meet these. 

*  E  - 2.5  What  information  is  made  publicly  available  on  inspection  /  enforcement? 
Please provide a web-address where any published material on inspections / enforcement 
may be found [voluntary information] 

63 

 
 
 
Year 

2013 

2014 

2015 

2016 

2017 

Number of 
announced 
inspections 
1,717 

Number of 
unannounced 
inspections 
978 

2,046 

2,080 

2,143 

2,045 

1,646 

1,388 

1,353 

1,367 

Total inspections 

Proportion 
unannounced 

2,695 

3,692 

3,468 

3,496 

3,412 

36% 

45% 

40% 

39% 

40% 

64 

 
 
 
 
It is important to note in this context that the lower numbers during the first years reflects the 
fact that the Directive obligations had yet to be transposed in the national legislation in some 
Member States. The last Member State adopted national legislation only in the spring of 2015. 

The Directive requires that one-third of user establishments should be inspected per year.  

18 Member States have performed more inspections than on one-third of total number of user 
establishments  for  that  Member  State  for  all  years  since  the  transposition  of  the  Directive. 
Other  Member  States  appear  not  to  have  achieved  this  in  some  years.  One  Member  States 
(Hungary)  has  performed  fewer  inspections  than  one-third  of  total  number  of  user 
establishments for that Member State for all five years of this report.  

All establishments breeding, supplying and/or using non-human primates must be inspected at 
least  once  per  year.  Member  States  which  have  non-human  primates  have  performed  more 
inspections  each  year  than  the  number  of  establishments  housing  non-human  primates. 
However, the reporting obligations do not allow for a conclusion to be made on whether there 
is  compliance  with  this  requirement  specifically,  that  is  to  say,  annual  inspections  in 
establishments  housing  non-human  primates,  even  if  total  number  of  inspections  was  to 
exceed this. 

Concerning  unannounced  inspections,  five  Member  States  have  reported  no  unannounced 
inspections (Czechia, Cyprus, Malta, Poland and Portugal). Despite this, the total proportion of 
unannounced inspection in the EU since the Directive took effect seem to be relatively high, 
up to around 40%.  

Inspections  are  carried  out  by  a  variety  of  persons,  such  as  veterinarians,  official  experts. 
Several Member States made reference to the minimum numbers of inspections as stated in the 
Directive, that is to say one-third of all user establishments every year and all establishments 
housing  non-human  primates.  One  Member  State  also  inspects  all  establishments  using 
domestic carnivores annually. 

The inspector is often accompanied by a representative of the establishment. In one Member 
State,  all  inspections  are  identified  in  order  to  give  notice  to  this  person,  although  most 
Member States did not report that this was necessary.  

Several Member States stated aspects inspected including animal housing standards inter alia 
ventilation,  temperature,  lighting,  noise,  availability  of  feed  and  water,  stocking  densities, 
bedding, hygiene, enrichment, animal health and care, record keeping in projects, and whether 
procedures complied with authorisations of projects. The documents from the Animal Welfare 
Bodies, and the functioning of them were also included by some. 

Several  stated  that  the  inspectors  use  a  common  check-list  to  ensure  inspection  of  relevant 
issues. 

Some communicated the result of the inspection back to the establishment and some included 
suggestions  for  improvement.  One  Member  State  has  performed  themed  inspections  aimed 
specifically at improving standards, and published summaries of common findings annually. 

65 

 
 
In cases where more serious issues were identified, Member States stated that administrative / 
legal  procedures  would  be  taken  sometimes  requiring  improvement  within  a  specified 
timeframe.  Some  Member  States  have  identified  a  declining  trend  in  non-compliance,  as 
evidenced in their inspection reports. 

One  Member  State  has  stated  that  centralising  the  duties  of  inspections  has  led  to  greater 
consistency and efficiency.  

E.3. Withdrawals of project authorisation (Article 44 of Directive 2010/63/EU) 

Reporting obligation 

“information  and  reasons  for  the  withdrawals  of  project  authorisation  during  the  reporting 
period” 

It  is  important  to  note  that  no  detailed,  numerical  data  are  required  on  withdrawals. 
Instead, Member States are required to provide information on reasons for withdrawals. 

Background 

Directive provides in its Article 44 the following: 

“1. Member States shall ensure that amendment or renewal of the project authorisation is 
required  for  any  change  of  the  project  that  may  have  a  negative  impact  on  animal 
welfare.  

2.  Any  amendment  or  renewal  of  a  project  authorisation  shall  be  subject  to  a  further 
favourable outcome of the project evaluation.  

3. The competent authority may withdraw the project authorisation where the project is 
not carried out in accordance with the project authorisation.  

4.  Where  a  project  authorisation  is  withdrawn,  the  welfare  of  the  animals  used  or 
intended to be used in the project must not be adversely affected.  

5.  Member  States  shall  establish  and  publish  conditions  for  amendment  and  renewal  of 
project authorisations.” 

Analysis 

Question in the questionnaire  

E  -  3 Provide  cumulative  information  covering  years  2013-2017  on  the  withdrawals  of 
project authorisation, and reasons thereof 

A  few  Member  States  commented  in  this  section  on  refusals  to  grant  authorities  rather  than 
removal  of  authorities  after  project  authorisation.  Other  Member  States  commented  on 
voluntary withdrawals by user or person responsible for project, for example when no funding 
is secured to conduct the work. 

One Member State noted that projects were withdrawn as under the new legislation, projects 
were no longer required for killing and harvesting of tissues after death. 

66 

 
 
19 Member States reported that no project authorisations were withdrawn during the reporting 
period. In other Member States where numbers were provided (voluntarily), only a few (one to 
three) projects were withdrawn. 

A variety of reasons were given: 

  animal welfare concerns;  
  poor experimental methodology/scientific design; 
  use of higher numbers of animals than authorised; 
 
  unsuitable facilities for the proposed animal work 
 

failing to provide statistical information on animal use; 

failure to provide the competent authority with reports on progress. 

E.4. Penalties (Article 60 of Directive 2010/63/EU) 

Reporting obligation 

“information on the nature of infringements as well as legal and administrative actions resulting 
from those infringements during the reporting period” 

It is important to note that no detailed, numerical data are required on penalties. Instead, 
Member  States  are  required  to  provide  information  on  the  nature  of  infringements, 
including those leading to legal and/or administrative actions.  

Question in the questionnaire [voluntary question] 

* E - 4.1 Provide a general description of the main rules and steps governing penalties in 
your MS that will put into context the cumulative information provided below in section 
4.2-4.4. Please note that administrative procedures may vary significantly between 
countries 

Although  a  non-mandatory  question,  21  Member  States  provided  some  information  on  the 
structures under which breaches of the legislation are dealt with, and/or some indication of the 
penalties applied. 

From  the  information  provided,  there  is  generally  within  the  Member  States  a  range  of 
administrative  and  legal  actions,  which  can  be  taken,  and  these  are  applied  proportionately 
dependent on the nature of the infringement. 

Typically,  minor  breaches  will  be  dealt  with  administratively  with  timely,  corrective  action 
required by the transgressor.  

Tariffs  are  escalated  where  there  is  reluctance  or  delays  to  the  introduction  of  corrective 
measures,  and,  in  particular,  where  avoidable  animal  suffering  has  occurred.  In  very  severe 
cases, a number of Member States have the option of imprisonment as a sanction.    

Analysis 

Questions in the questionnaire  

E – 4.2 Provide cumulative information covering years 2013-2017 on the nature of 
infringements 

67 

 
 
E – 4.3 Provide cumulative information covering years 2013-2017 on the nature of 
administrative action as a result of infringements 

E – 4.4 Provide cumulative information covering years 2013-2017 on the nature of legal 
actions as a result of infringements 

There  were  significant  differences  in  the  quantity  and  quality  of  information  provided  by 
Member States on infringements encountered, and administrative and/or legal actions imposed 
as a consequence of such infringements. 

Three  Member  States  (Estonia,  Malta  and  Portugal)  indicated  that  no  infringements  were 
recorded in the reporting period and two Member States (Italia and Latvia) indicated that there 
had been no cases severe enough to warrant administrative or legal action. 

The  remaining  Member  States  provided  information  on  the  types  of  infringements  that  had 
been encountered, and action taken. 

Commonly  reported  infringements  included  performance  of  procedures  without  appropriate 
authorisation,  inappropriate  record  keeping,  inadequate  training  and  failure  to  meet 
requirements of Annex III (accommodation and care).  

All  reported  a  proportionate  response  was  taken,  dependent  on  the  severity  of  the 
infringement.  

The majority of infringements were dealt with  by  administrative means,  requiring corrective 
measures be put in place to prevent recurrence. A number of Member States noted that follow 
up inspections were often made to ensure any deficiencies had been resolved.  

Few reports of legal action were reported, with such action generally kept for the more severe 
cases, in particular those involving unnecessary animal suffering.  

One  Member  State  (United  Kingdom)  reported 
infringements and actions were published annually. 

that  (anonymised) 

information  on 

Question in the questionnaire [voluntary question] 

* E - 5 Has the EU Guidance on Inspections and Enforcement been made available to all 
inspectors? Yes/No 

EU Guidance made available 

Yes 
No 
n/a 
(blank) 
Total 

25 
1 
2 
6 
28 

Question in the questionnaire [voluntary question] 

* E - 6 Has additional official guidance on Inspections and Enforcement been developed 
to facilitate implementation? Yes/No 

68 

 
 
 
 
National guidance developed 

Yes 
No 
(blank) 
Total 

8 
16 
6 
28 

Question in the questionnaire [voluntary question] 

* E - 6.bis If you consider this guidance helpful for other Member States to facilitate the 
implementation  of  the  Directive,  please  provide  web-address  for  the  guidance,  where 
available 

Provided links to websites are available in the detailed Member State summaries. 

F. OTHER – ADDITIONAL VOLUNTARY QUESTIONS  

Member  States  were  invited  to  provide  their  views  and  comments  on  the  implementation  of 
the  Directive,  highlighting  areas  of  difficulty,  on  well-functioning  elements,  on  areas  where 
further collaborative efforts could improve implementation.  

Eighteen Member States provided comments for one or more of the questions. 

F.1. Problematic areas for implementation of the Directive 

Question in the questionnaire [voluntary question] 

*  F  -1  Please  provide  here views  on  problematic  areas  for  implementation  of  the 
Directive in your Member State 

Fifteen Member States responded to this question. Answers included: 

  Ensuring  sufficient  expertise  for  Animal  Welfare  Bodies  and  other  roles  in  small 

establishments. 

  Provision for farm animal accommodation could be improved. 

  Ensuring sufficient training for and trained staff for competent authority tasks, including 
for  National  Committee.  This  can  lead  to  delays  in  meeting  project  authorisation 
deadlines. 

  Availability of sufficient education and training courses can delay scientific work. 

  Maintaining anonymity of non-technical project summaries in small Member States. 

  The  killing  of  animals  for  tissues  and  organs  is  not  subject  to  authorisation,  with  only 

numbers reported in the five-year cycle. 

  No common up-to-date database of available alternative methods. 

  Where  not  in  place  under  previous  legislation,  significant  increase  in  costs  and 

administrative burden to implement new requirements such as project authorisation 

69 

 
 
 
 
 
  Difficult  to  decide  which  animal  has  the  lowest  capacity  to  experience  pain,  suffering, 
distress or lasting harm (text replaced from Directive 86/609 “…involve animals with the 
lowest degree of neurophysiological sensitivity..”). 

F.2. Views on well-functioning elements of the Directive in your Member State  

Question in the questionnaire [voluntary question] 

* F -  2 Please provide  here views  on  well-functioning  elements  of  the Directive in  your 
Member State 

Fifteen Member States responded to this question. Answers included: 

 

Inspection is easier due to defined standards and authorities. 

  Project  evaluation  and  authorisation  –  improved  implementation  of  the  Three  Rs. 

Development of standardised project application and evaluation forms. 

  Requirement for harmonised training and competence framework. 

  Animal  Welfare  Bodies  promoting  and  overseeing 

improved  standards  within 

establishment, including culture of care. 

 

Improved transparency – non-technical project summaries and annual statistical reporting. 

F.3.  Views  on 
implementation of the Directive  

issues  that  would  benefit  from  collaborative  efforts  to 

improve 

Question in the questionnaire [voluntary question] 

* F - 3 Please provide here views on issues that would benefit from collaborative efforts 
to improve implementation of the Directive 

Thirteen Member States responded to this question. Answers included: 

  Continue to promote consistency in education and training requirements for all those with 
responsibilities  under  the  Directive.  Consider  some  sort  of  European  certification  of 
common standards. Central repository of “certified” training courses would be helpful. 

  Guidance on good re-homing practices would be helpful. 

  Provision of an easily searchable database for non-technical project summaries. 

  Continue  meetings  of  National  Contact  Points  (Article  59)  and  National  Committees 

(Article 49). 

 

Improved use of EC IT tools for sharing of Member States guidance material. 

  Central, up-to-date database on alternative (Three Rs, in particular replacement) methods. 

  Development of training courses for the competent authorities, evaluators, inspectors, etc. 
on their respective aspects and task (similar to DG SANTE’s BTSF (Better Training for 
Safer Food) programme). 

  Promote consistency in requirements concerning genetically altered animals. 

70 

 
 
F.4. Any other additional comments concerning the implementation of the Directive  

Question in the questionnaire [voluntary question] 

*  F  -  4  Please  provide  here  any  other  additional  comments  concerning  the 
implementation of the Directive 

Eight  Member  States  responded  to  this  question.  All  of  the  responses  are  available  in  the 
Member State summaries. 

  Nuances  in  transposition  among  Member  States  due  to  differing  interpretations  and  an 
indication that interpretation of some of the terminology is not straightforward depending 
on local implementation. For example, in some Member States an establishment may have 
several 'user' authorisations, whereas in others one 'user' authorisation may include several 
facitilites. 

 

It  was  expressed  that  some  time  is  needed  without  changes  to  the  legislation,  nor  to  its 
interpretation, to facilitate its correct application. 

  A review of reporting of exemptions in the next five-year implementation report has been 
requested  due  to  repetitive  nature  of  exemptions  and  the  likelihood  of  the  reasons 
remaining the same from one reporting period to another. 

COMMISSION 

G. 
IMPLEMENTATION OF THE DIRECTIVE 

ACTIVITIES 

TO 

FACILITATE 

THE 

G.1. Transposition conformity checks 

According  to  Article  61  of  the  Directive,  the  Member  states  were  required  to  adopt  and 
publish, by 10 November 2012, the laws, regulations and administrative provisions necessary 
to comply with the Directive. 

A majority of Member states did not comply with this requirement and the Commission had, 
in 2013, to open infringements procedures (in accordance with Article 258 of the Treaty of the 
Functioning  of  the  European  Union)  for  non-communication  of  the  transposition  measures 
against 15 Member states13. Further to the subsequent adoption of the transposition measures, 
these procedures were closed and finally all Member States have transposed into their national 
law the Directive. 

The  Commission  services  carried  out  subsequently  systematic,  in-depth  assessments  of  the 
conformity of the transposition measures in order to check whether these measures correctly 
transpose  the  provisions  of  the  Directive.  Since  several  instances  of  possible  incorrect 
transpositions  issues were identified, the Commission  services entered into dialogue  with  all 
Member  States  in  order  to  gather  further  explanations  and  information  from  them.  The 
dialogue between the Commission  services  and the Member States  gives a possibility to  the 
Member States concerned to address identified shortcomings. Depending on the replies given 
by the Member States, the Commission has been able to successfully conclude the discussions 
with  eight14  Member  States.  Where  the  issues  could  not  be  addressed  in  the  frame  of  this 

13 BG, DE, EL, ES, FR, IT, CY, HU, MT, NL, PL, PT, RO, SI and FI 
14 BE, IE, EL, HR, CY, LT, LU and MT 

71 

 
 
 
 
                                                           
dialogue, the Commission decided to open several infringement procedures in accordance with 
Article 258 of the Treaty of the Functioning of the European Union.  

By mid of October 2019, the Commission has opened 1515 infringement procedures for non-
conforming  transposition  of  the  Directive.  Two16  out  of  these  15  procedures  could  be 
successfully closed since the concerned Member States took the necessary measures. Further 
procedures  may  be  launched  against  other  Member  States  on  the  basis  of  the  ongoing 
assessment of their replies. 

G.2.  Other  activities  to  facilitate  correct  and  comprehensive  implementation  of  the 
Directive. 

To achieve the aims of the Directive, a uniform understanding on the Directive’s obligations 
and  objectives  across  the  EU  is  imperative.  The  European  Commission  has  gone  to  great 
length to facilitate correct implementation of the Directive.  

The European Commission hosts meetings of National Contact Points set up under Article 59 
of  the  Directive  twice  a  year  to  identify  and  discuss  issues  on  implementation.  These  issues 
can be divided in three categories: 

1.  Questions related to correct interpretation of a legal term or requirement; 
2.  Questions related to concepts in the Directive. 
3.  Questions  related  to  Member  State  administrative  processes  for  implementing  the 
Directive, including tools to reduce administrative burden; 

For  questions  in  the  first  category  the  Commission  developed  a  Q&A  document,  which  is 
published on the Commission web-site17, and is being kept up to date.  

Concerning  questions  related  to  concepts  in  the  Directive,  the  Commission  hosted  several 
expert working groups, with experts nominated by Member States, science/academia, industry, 
animal  welfare  organisations  and  other  specialist  organisations  (such  as  laboratory  animal 
veterinarians,  laboratory  animal  breeders,  animal  technologists).  The  objectives  of  these 
working  groups  were  to  develop  EU  guidance  and  common  lines  to  topics  of  importance  to 
harmonise their implementation.  

The guidance documents, endorsed by the National Contacts Points of the Member States, are 
available  in  all  community  languages  to  make  them  accessible  to  widest  possible  audience. 
The current series of EU guidance consist of 

  Project evaluation and retrospective assessment; 
  Education and training framework; 
  Severity assessment framework; 
  Animal Welfare Bodies and National Committees; 
 

Inspections and enforcement. 

15 CZ, DK, DE, EE, ES, IT, LV, HU, AT, PL, PT, RO, SI, SK and FI  
16 EE and ES 
17 https://ec.europa.eu/environment/chemicals/lab_animals/interpretation_en.htm 

72 

 
 
 
                                                           
Questions on administrative processes are discussed on a regular basis, encouraging sharing of 
good  practice  among  Member  States.  Through  discussions  with  Member  States  and  other 
stakeholders, the Commission developed tools covering inter alia   

 
 
 

inspection risk analysis criteria and Aide Memoire; 
pre-formulated questions for building a project application template;  
recommended template for a non-technical project summary. 

In  addition,  the  European  Commission  together  with  Member  States  developed  a  common 
template  for  collecting  and  submitting  statistical  data  under  the  Directive.  This  is  to  share 
resources and minimise the administrative burden. 

The  role  of  National  Committees  is  important  for  the  functioning  of  the  Animal  Welfare 
Bodies,  and  for  advising  competent  authorities  in  matters  dealing  with  the  acquisition, 
breeding, care and use of animals. To aid their work, the Commission hosted two meetings of 
National Committees to explore areas of common interest and share good practice. 

The review of the Directive, adopted in November 201718, identified problems in the quality 
and  timeliness  of  the  publication  of  non-technical  project  summaries  of  authorised  projects.  
The  Commission  took  the  initiative  to  streamline  and  modernise  reporting  obligations 
resulting in adoption of amendments to the Directive through Regulation (EU) 2019/101019 in 
June  2019.  These  include  setting  up  open  access,  searchable  central  EU  databases  for  non-
technical  project  summaries  and  statistical  data,  significantly  improving  transparency  of 
animal use in the EU. 

With  additional  funds  provided  by  the  European  Parliament,  the  Commission  was  able  to 
initiate an EP Pilot Project focusing on education, training and information sharing activities 
on  the  Three  Rs.  The  project  aims  at  expediting  the  development  and  validation  of  new 
alternatives,  and  the  uptake  of  existing  alternatives  through  better  implementation  of  the 
Directive. This project will deliver six interactive eLearning training modules covering some 
of  the  key  aspects  of  the  Directive,  such  as  on  the  severity  assessment  framework,  project 
evaluation and how to search for non-animal alternatives. 

Making these modules available to project applicants, project evaluators, inspectors and those 
working  with  animals,  can  have  a  significant  impact  in  improving  consistency  of 
implementation of the Directive across the EU. The modules are expected to be finalised by 
the end of 2020. 

Under  the  same  project,  funding  was  granted  for  the  European  Education  and  Training 
Platform  for  Laboratory  Animal  Science  (ETPLAS),  established  on  the  basis  of  a 
recommendation  in  the  EU  Guidance  on  Education  and  Training  Framework,  to  develop 
practical  tools  and criteria for the assessment of  learning outcomes and competence of staff. 
The harmonised approach to competence assessment across the EU is expected to have a great 
impact on improving the competence of those working with the animals, in line with the aims 
of Directive obligations under Article 23.  

18 COM/2017/0631 final 
19 OJ L 170, 25.6.2019, p. 115–127 

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