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  COM(2020) 15 final  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   {SWD(2020) 15 final}  
 
 
    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 

1. Introduction 

In June 2019, Directive  2010/63/EU on the protection of animals  used for scientific purposes1 
("the  Directive")  was  amended  by  Regulation  (EU)  2019/10102  (“the  Regulation”),  and  in 
particular its Article 54(1) on Member State obligation to submit to the Commission a report on 
its  implementation  by  10  November  2018.  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.    

The report focuses on the key elements affecting the implementation, as defined in Annex I (“the 
Annex”) of Commission Implementing Decision 2012/707/EU3. However, it is not an exhaustive 
account of all national implementation measures. The report is accompanied by the Commission 
Staff Working Document4.  

The  content  and  quality  of  Member  States’  reports  varied.  All  Member  States  submitted  their 
report, 22 by the deadline of 10 November 2018, with the last report received in February 2019, 
and  final  corrections  in  early  September  2019.  Some  Member  States  provided  additional, 
voluntary information. Late submissions and inconsistent quality of reporting made the drawing 
of conclusions at EU level challenging.  

This  report  does  not  prejudge  the  Commission’s  stance  in  any  infringement  procedure  on  the 
compatibility of national implementation measures with Union law. 

2. Changes to national legislation  

All Member States made changes to their national legislation to transpose the Directive, but the 
extent of these varied significantly, dependent also on how the previous Directive (86/609/EEC) 
had been implemented. 

The new requirements for severity classification and reporting, non-technical project summaries, 
retrospective assessment and timeliness of authorisation decisions led to changes in all national 
legislations. In addition, most Member States reported having made major changes due to: 

the extended scope; 

 
  new requirements for accommodation and care and methods of killing; 
 

the risk-based approach to, and frequency of, inspections.  

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

1 

 
 
                                                           
In addition, the focus on alternative approaches caused many Member States to consider how to 
best meet the provisions in the Directive. Some set up Three Rs5 centres voluntarily to promote 
alternatives.   

3. Key elements of the reporting on the Directive 

3.1 Structures and framework of competent authorities  

In  21  Member  States,  one  ministry  is  responsible  for  implementing  the  Directive,  mostly  the 
ministry for agriculture and environment; sometimes the ministry for health, education, science 
and innovation. In Belgium, Germany, Greece, Spain, France, Poland and the United Kingdom it 
is a shared responsibility between two or more ministries. 

A competent authority must carry out five tasks: authorisation and inspections of establishments, 
project  evaluation,  project  authorisation  and  retrospective  assessment.  Under  the  Directive,  a 
competent authority does not have to be a public body, provided it has the required expertise and 
infrastructure, and is free from any conflict of interests as regards the performance of the tasks. 

Member  States’  structures  vary  greatly  from  central  to  regional  and  local.  Sometimes  the 
designation of tasks between competent authorities even varies between different regions within 
a Member State. 

15  Member  States  reported  having  one  public  competent  authority  for  all  five  tasks.  Two  of 
these  have  a  regional  structure  with  each  region  delivering  all  five  tasks.  13  Member  States 
indicated more than one competent authority. 

The more common task division is that inspection and authorisation of breeders, suppliers  and 
users  are  separate  from  project  evaluation  and  authorisation,  and  retrospective  assessment. 
Inspection is often done by veterinary authorities.  

The  structures  for  project  evaluation  and  authorisation  also  differ  greatly  –  from  single 
committees (competent authorities) charged with evaluation and authorisation for all projects in 
the Member State, to regional structures (e.g.  Germany (26), Austria (10) and Sweden (6)) to 
local ethics committees which evaluate only local projects, or within a single establishment (for 
example  Belgium  (33),  France  (125)).  Romania  indicated  one  competent  authority,  but  in  a 
separate  instance  stated  that  the  project  evaluation  is  carried  out  by  ethics  committees  set  up 
within the establishments of users. 

5 To Replace, Reduce and Refine the use of animals for scientific purposes 

2 

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

Member State 

CA for authorisation of  
establishments 

CA for inspections 

CA for project 
evaluation 

CA for project 
authorisation 

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 

1 

R 

N 

R 

R 

R 

R 

N 

N 

N 

O 

R 

N 

P 

P 

P 

P 

P 

P 

P 

P 

P 

P 

P 

3 

14 

285 

11 

71 

17 

1 

19 

1 

1 

305 

2 

21 

R 

R 

R 

R 

R 

R 

N 

R 

N 

N 

O 

R 

R 

P 

P 

P 

P 

P 

P 

P 

P 

P 

P 

P 

33 

8 

26 

1 

57 

89 

125 

1 

2 

17 

11 

1 

6 

O 

O 

R 

N 

R 

N 

O 

N 

N 

R 

O 

N 

R 

NP 

P 

P 

P 

P/NP 

NP 

P 

P 

NP 

P 

P 

P 

33 

8 

26 

1 

13 

17 

1 

19 

2 

1 

11 

1 

6 

O 

O 

R 

N 

R 

R 

N 

R 

N 

N 

O 

N 

R 

NP 

P 

P 

P 

P 

P 

P 

P 

P 

P 

P 

33 

8 

26 

1 

57 

89 

125 

1 

1 

1 

11 

1 

1 

O 

O 

R 

N 

R 

N 

O 

N 

N 

N 

O 

N 

N 

NP 

P 

P 

P 

P/NP 

NP 

P 

P 

P 

P 

P 

Table 1.  Number and type of competent authorities (CA) for the 13 Member States with more than one competent authority in 2017  

3 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
It  is  acknowledged6  that  the  more  competent  authorities  are  involved  in  implementing  the 
Directive within a Member State, the greater the challenges are to ensure a consistent approach 
and outcome. 

Methods  to  promote  consistency  include  training,  regular  meetings  of  competent  authorities, 
standardised project application and evaluation forms, standard checklists for authorisation and 
inspection of establishments. 

Given the significant variations in competent authority structures across Member States it is not 
surprising  that  the  2017  review  of  the  Directive7  identified  difficulties  for  the  scientific 
community and raised concerns over inconsistencies.  

 3.2 National Committees 

According  to  the  Directive,  each  Member  State  must  establish  a  National  Committee  for  the 
protection  of  animals  used  for  scientific  purposes.  It  advises  the  competent  authorities  and 
Animal Welfare Bodies on matters dealing with the acquisition, breeding, accommodation, care 
and use of animals in procedures and ensures sharing of best practice. 

Some Member States already had similar committees in place, whereas others had to  establish 
one. Hence, the experience of the National Committees varies.  

In most Member States, National Committees developed effective communication channels with 
Animal  Welfare  Bodies  for  sharing  relevant  information  and  best  practice,  including  Q&A 
systems. 

As  the  role  of  the  National  Committee  evolves,  links  between  Animal  Welfare  Bodies  and 
National  Committees  are  expected  to  get  stronger,  but  their  effectiveness  greatly  depends  on 
appropriate resourcing by the Member State.  

3.3 Education and Training 

The  Directive  requires  appropriate  education  and  training  for  staff  carrying  out  procedures, 
caring for animals, killing animals and designing procedures and projects. General requirements 
are  included  in  national  legislation,  most  Member  States  have  published  the  EU  Guidance 
document on Education and Training Framework8 and some have produced additional guidance. 
Several Member States reported on-going activities to improve training provision. 

Staff conducting procedures, caring for animals or killing animals must be supervised until their 
competence  is  assessed.  This  is  a  new  requirement  and  many  Member  States  do  not  yet  have 
formal  systems  for  supervision  and  competence  assessment.  A  few  Member  States  noted  that 
further guidance was in preparation. Some training providers and ETPLAS9 are developing tools 
for consistent competence assessment. 

Despite the diversity of training, no comments suggested that a lack of competence was an issue.  
The education and training requirements, including attainment and maintenance of competence, 
are often checked during inspections, suggesting that there is oversight of outcomes and that if 
training were less than ideal, it could be identified and remedied. 

6 https://ec.europa.eu/environment/chemicals/lab_animals/pdf/guidance/project_evaluation/en.pdf 
7 COM/2017/0631 final 
8 https://ec.europa.eu/environment/chemicals/lab_animals/pdf/guidance/education_training/en.pdf 
9 Education and Training Platform for Laboratory Animal Science, https://www.etplas.eu  

4 

 
 
 
                                                           
The  2017  review  of  the  Directive  suggested  difficulties  for  staff  and  researchers  in  moving 
between  Member  States  as  education  and  training  requirements  differed,  requiring  additional 
training delaying the start of work. 

Some  Member  States  recognise  training  courses  from  other  Member  States  or  external  course 
accreditors, for example FELASA10, allowing persons from another Member State to skip some 
intra-Member State training.  

Only eight Member States indicated having additional training requirements for personnel from 
another Member State. 

3.4 Project evaluation and authorisation, and retrospective assessment of projects 

During project evaluation, all applications to use animals must be carefully considered to ensure 
the animal use is justified, the Three Rs are applied and that a harm-benefit assessment is carried 
out.  A  project  authorisation  can  only  be  granted  if  the  competent  authority  gives  a  favourable 
project evaluation.  

Many  Member  States  have  structures  in  place,  mostly  templates  and  guidance,  to  facilitate 
consistency  of  and  correct  information  for  the  evaluation.  A  few  Member  States  also  include 
other  tools  such  as  training  for  project  applicants  and  evaluators,  and  electronic  application 
systems, which are reportedly speeding up processing times. 

There  are  different  evaluation  processes,  ranging  from  national  to  regional  and  local.  Equally, 
committee structures vary in size – from very large to small groups or evaluations by individuals 
(with other support where necessary). 

Some  evaluators  work  with  local  Animal  Welfare  Bodies  or  local  ethical  review  groups  for  a 
local perspective and/or opinion on the application to better inform the evaluation process. 

Impartiality  and  lack  of  conflict  of  interest  must  be  assured,  especially  when  the  project 
evaluation  is  tasked  to  a  non-public  authority.  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  their  department’s  work  is  being  assessed.  This  is  an  issue  in 
particular  for  project  evaluation  done  by  local  committees.  Declarations  are  used  to  state 
impartiality/lack  of  conflict  of  interest.  In  some  cases,  an  independent  member  of  the 
government department provides oversight, or a second tier of review is carried out at national 
level. A few Member States actively encourage independent involvement in the process.  

Relatively few applications are refused, as they  are  generally revised and improved during the 
process. An application may also be withdrawn before it is formally refused. 

Most Member States are making strenuous efforts to comply with the Directive’s requirements 
on project evaluation and authorisation. 

To facilitate competitive EU research, the Directive introduced a 40-day  deadline for deciding 
on  authorisation  and  informing  the  applicant.  Only  in  justified  cases,  this  deadline  could  be 
extended  by  15  days.  Circumstances  for  deadline  extensions  included  projects  of  complex  or 
multi-disciplinary nature with large numbers of animals and use of controversial procedures. 

A comparison of numbers of authorised projects between Member States is not relevant due to 
differences  in  interpretation  of  what  constitutes  “a  project”.  However,  there  are  major 
differences among Member States regarding the proportion of decisions taken beyond 40 days. 
Three Member States did not provide data on this. 

10 Federation for Laboratory Animal Science Associations, www.felasa.eu  

5 

 
 
 
 
                                                           
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% 
74% 
100% 
100% 

0% 
7% 

60% 
0% 
3% 
43% 
0% 
0% 

Table 2. Project authorisation decisions per Member State in 2017 
*) Numbers calculated from the data provided in the other columns 

Projects  involving  severe  procedures  and/or  non-human  primates  as  well  as  those  selected  by 
competent authorities during the project evaluation, are subject to retrospective assessment by a 
competent  authority  to  consider  whether  the  objectives  were  achieved,  to  consider  the  harm 
inflicted on the animals, and to identify any elements that could lead to further implementation 
of  the  Three  Rs.  It  is  relatively  early  to  assess  the  implementation  of  this  requirement  as  the 
transitional  measures  for  project  authorisation  covered  projects  until  31.12.2017.  The  main 
reasons given for selecting projects for a retrospective assessment (beyond those for which it is 
compulsory)  were  in  relation  to  concerns  on  animal  welfare  due  to  use  of  complex  or  novel 
technology,  new  disease  models,  lengthy  anaesthetic  episodes,  potential  for  cumulative 
suffering, large numbers of animals or uncertainties on proposed design or group sizes.  

6 

 
 
 
 
 
 
 
 
 
 
 
3.5 Non-technical project summaries 

The  Directive  requires  that  non-technical  summaries  of  authorised  projects  are  published  to 
inform the public on live animal use. All Member States use a template included in the project 
application, with many using the EU template as guidance. 

Initially  the  quality  of  the  content  and  the  time  to  publication  were  a  concern.  However,  as 
experience grew, the content improved, and the time to publication was reduced, thanks to  IT-
systems to host these non-technical project summaries.  

From 2021 onwards, the publication of non-technical project summaries will be required through 
a central EU database and within six months of the authorisation of the project11. 

3.6 Animals bred for use in procedures 

Under the Directive, as part of the implementation report, Member States must now provide data 
once every five  years, on all “other” animals: bred and killed, but not used. These animals are 
not  reported  in  the  annual  statistics.  Together,  the  annual  statistical  report  and  the 
implementation report give a comprehensive picture of all animals needed to support research, 
testing and education/training in the EU in a given year.  

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.  These  include  also  those  bred  and 
humanely killed for their organs and tissues, for example to be used in alternative (animal tissue-
based) methods. These numbers also  include many breeding animals  that arrived at  the end of 
their breeding life. Finally, they include those that were intended for use, but for example, were 
ill and killed humanely before being used. Sometimes, animals may need to be killed on welfare 
grounds and in order to protect the health and scientific integrity of the colony. 

Types of animals 

Number of conventional animals bred, killed and not used in procedures  

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

Number of animals bred and killed for the maintenance of an established 
genetically altered line (those not covered by project authorisation and 
excluded from annual statistical reporting) 

Total  

Numbers 

6,484,535 

525,085 

5,588,196 

12,597,816 

Table 3. Numbers of animals bred, killed and not used in procedures in the EU in 2017  

91% of the animals  reported are mice (83%) and zebra fish (7%). Good  oversight  of breeding 
programmes  is  essential  to  minimise  surplus  animals  as  far  as  practicable,  but  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.  

11 OJ L 170, 25.6.2019, p. 115–127; Article 6 

7 

 
 
 
 
                                                           
3.7 Sourcing of non-human primates 

The Directive promotes second or higher generation purpose-bred (F2/F2+) non-human primates 
in  the  EU.  From  the  implementation  reports,  it  can  be  concluded  that  all  authorised  breeding 
establishments in the EU are already supplying only F2/F2+ animals today.  

To  advance  the  aims  of  the  Directive  globally,  where  animals  are  sourced  from  non-EU 
countries,  Member  States  strive  to  obtain  only  F2/F2+  animals,  and  are  encouraging  non-EU 
breeders, although they are not within EU jurisdiction, to increase the supply of F2/F2+ animals.  

3.8 Exemptions from requirements within the Directive 

The Directive allows exemptions to be granted in relation to species that must be purpose-bred, 
the  place  where  procedures  are  carried  out,  the  conditions  on  reuse  of  animals,  and 
accommodation and care requirements. 

15  Member  States  reported  exemptions  to  use  non  purpose-bred  animals,  mainly  to  carry  out 
work in the wild, or on pet dogs and cats in veterinary research to investigate clinical disease and 
novel  treatments.  22  Member  States  authorised  exemptions  to  allow  work  outside  a  user 
establishment.  Work  in  the  wild  was  the  most  common  reason  to  investigate  animals  in  their 
natural habitat, followed by research under commercial conditions on farm animals, and work in 
veterinary practices.  

Reuse  after  the  animal  has  experienced  severe  pain  in  the  previous  procedure  may  only  be 
approved in  exceptional  circumstances. Only one Member State reported  that some derogation 
was permitted in certain projects without providing information on the specific circumstances.  

18 Member States reported that exemptions were authorised from the care and accommodation 
standards.  The  circumstances  included  use  of  metabolic  cages,  whose  dimensions  were  below 
those  set  out  in  Annex  III;  “commercial  stocking  densities”  during  research  studies  in 
agricultural  animals  into  for  example  mechanisms  of  spread  of  infectious  disease;  single 
housing, for example, to measure behavioural responses to stimuli; and food/water control as a 
motivational tool in training animals to perform novel or learned tasks. 

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

3.9 Animal Welfare Body 

Each establishment which breeds, uses or supplies animals must have an Animal Welfare Body 
to advise staff on issues relating to the welfare and care of animals; on aspects of the Three Rs; 
to establish and review internal operational processes regarding the welfare of animals housed or 
used; to follow the development and outcome of projects and to advise on rehoming schemes. 

In  many  Member  States,  the  composition  of  Animal  Welfare  Bodies  is  broader  than  the 
minimum set out in the Directive. Almost one-third 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  laypersons  have  been  included  by  a  few.  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.  

8 

 
 
Animal Welfare Bodies are recognised as a very positive step to improve welfare and science. 
Their inputs have raised awareness of the importance of applying 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. 

3.10 Principles of replacement, reduction and refinement 

The Directive requires a systematic application of the Three Rs in all interaction with animals. 
The  responses  to  how  the  Three  Rs  are  addressed  satisfactorily  within  authorised  projects  and 
during housing and care included:  

  Project application forms have specific sections on the Three Rs, requiring, for example, 

literature reviews and searches on the Three Rs; 

  Animal  Welfare  Bodies  advise  project  applicants  on  the  Three  Rs,  and  ensure 
implementation of the Three Rs is continuously reviewed and updated during the project; 
  Experts’ challenge on the Three Rs during project  evaluation,  and  compliance with  the 

Three Rs is checked as part of the inspection process. 

3.11 Tissue sampling of genetically altered animals 

Member States were required to submit representative data on the methods used for genotyping 
(genetic characterisation of an animal) during the creation, maintenance  and use of genetically 
altered animals.  

However,  due  to  numerous  errors  in  the  reporting,  it  was  difficult  to  draw  conclusions  hence 
only the data on mouse tissue sampling methods were analysed. 

For  over  half  the  mice  sampled,  tissue  coming  from  identification  of  the  animal  was  used  for 
genotyping, hence not  adding further welfare harm to  the  animal.  89% of those samples came 
from ear clipping and 11% from toe clipping. 

In terms of methods used under a project authorisation, tail biopsy, followed by ear biopsy are 
the  most  common.  The  reported  severities  differed  (mild  or  moderate).  The  reasons  for  the 
differences are not reported but may be due to refinement techniques such as anaesthesia (local 
or general) and analgesia. 

Less  than  2%  of  methods  reported  are  “non-invasive”  (below  threshold  of  minimum  pain, 
suffering, distress or lasting harm requiring project authorisation). This concerns mostly the use 
of  post-mortem  material,  or  the  use  of  observation,  exposure  to  specific  lighting  conditions  or 
hair sampling.  

This  information  will  serve  as  a  baseline  for  future  reports.  The  obligation  to  refine  tissue 
sampling  methods  should  be  systematically  addressed.  When  invasive  methods  are  used  for 
identification,  these  should  provide  surplus  tissue  for  genotyping.  As  non-invasive  methods 
become available, these should be taken up where technically possible.    

3.12 Enforcement 

3.12.1 Authorisation of breeders, suppliers and users  

In the EU, in 2017, there were just under 4000 active authorised breeders, suppliers and/or users 
of  animals  carrying  out  procedures  under  around  16,500  authorised  projects.  A  comparison  of 
numbers  between  Member  States  is  discouraged  because  the  terms  ‘breeder/supplier/user’  and 
‘project’ may be regulated differently. For example, in one Member State a university may hold 
only  one  'user'  authorisation  covering  all  of  its  animal  facilities  compared  to  another  Member 

9 

 
 
State  in  which  each  animal  facility  (within  the  same  university)  is  considered  a  separate  legal 
person holding an individual user authorisation. 

Total number of authorised breeders, suppliers and users   Total number of authorised projects 

2013 
2014 
2015 
2016 
2017 

2,477 
3,547 
3,816 
3,759 
3,862 
Table 4. Numbers of operators and authorised project in the EU, years 2013 - 2017  

6,063 
11,210 
15,044 
15,246 
16,708 

3.12.2 Withdrawals of project authorisation, and authorisations of breeders, suppliers and users 

19 Member States stated that no project authorisations were withdrawn in the reporting period. 
The  others  gave  a  variety  of  reasons  for  withdrawing  authorisations:  animal  welfare  concerns; 
poor  experimental  methodology/scientific  design;  use  of  higher  numbers  of  animals  than 
authorised and failure to provide statistical information on animal use. 

21 Member States stated that no authorisations for breeders, suppliers or users were withdrawn 
in the reporting period as a consequence of enforcement action. One Member State reported that 
some establishments closed due to their inability to meet the new requirements in Annex III on 
accommodation and care. Authorisations withdrawn were due to water damage, failure to meet 
building  requirements,  and  one  failure  to  renew  the  application.  Five  Member  States  did  not 
provide any information in response to this question. 

3.12.3 Infringements, administrative and legal actions, and penalties 

Member States  use a range of administrative and legal  actions, dependent on the nature of the 
infringement.  Typically,  minor  breaches  are  handled  administratively  requiring  timely, 
corrective action by the transgressor.  

Tariffs  increase  in  case  of  inaction  or  delay  in  taking  corrective  measures,  and,  in  particular, 
where  avoidable  animal  suffering  has  occurred.    For  very  severe  cases,  some  Member  States 
have the option of imprisonment as a sanction.  

Three Member States recorded no infringements in the reporting period and two Member States 
stated that there were no cases severe enough to warrant administrative or legal action. All other 
Member  States  provided  information  on  the  types  of  infringements  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.  

Most infringements were handled administratively, with corrective measures to be put in place 
preventing  recurrence.  Some  Member  States  carry  out  follow-up  inspections  to  ensure 
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  reported  that  (anonymised)  information  on  infringements  and 
actions was published annually. 

3.12.4 Inspections  

Member  States  must  ensure  regular  inspections  by  competent  authorities  of  all  breeders, 
suppliers and users and their establishments, to verify compliance with the Directive.  

10 

 
 
 
 
The competent authority must adapt the frequency of inspections based on a risk analysis, taking 
account of the number and species of animals housed, the previous history of compliance with 
the  Directive,  the  number  and  types  of  projects  carried  out  by  the  user  in  question  and  any 
information that might indicate non-compliance.  
24 Member States confirmed using the EU Inspection Risk Analysis Criteria12. 

Inspections must be carried out on at least one third of the users each year. However, breeders, 
suppliers  and  users  of  non-human  primates  must  be  inspected  at  least  once  a  year.  An 
appropriate proportion of the inspections must be carried out without prior warning.  

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 

Table 5. Numbers of inspections in the EU, years 2013 - 2017  

Total inspections 

Proportion 
unannounced 

2,695 

3,692 

3,468 

3,496 

3,412 

36% 

45% 

40% 

39% 

40% 

18 Member States performed more inspections (covering users, breeders and suppliers) than one 
third  of  the  number  of  authorised  users  in  their  Member  State  per  year.  Nine  Member  States 
appear not to have achieved one third in some years. One Member States  has performed fewer 
inspections in all five years.  

Five Member States  reported no unannounced inspections. Despite this, the total proportion of 
unannounced inspections in the EU since the Directive took effect seems to be relatively high, 
around 40%. 

12 https://ec.europa.eu/environment/chemicals/lab_animals/pdf/guidance/inspections/en.pdf 

11 

 
 
 
 
                                                           
Table 6. Proportion of unannounced inspections by Member State, years 2013 - 2017  

4. Conclusions 

The implementation of the Directive rather varies between Member States. However, it is clear 
that  most  Member  States  are  making  determined  efforts  to  comply  with  the  Directive. 
Experience of the new legislative requirements is still at  an  early stage,  in  particular for those 
Member States whose transposition was slow. 

Education  and  training  requirements  continue  to  differ  between  Member  States  even  if  some 
simplified  processes  have  been  installed  to  facilitate  movement  of  scientists.  Differences  in 
project  application  and  evaluation  processes  and  authorisation  times  continue  to  impact 
negatively on the objective of achieving a level playing field for scientists across the EU.  

The  implementation  of Animal  Welfare  Bodies  and  National  Committees  has  been  successful, 
although influenced by the available resources. 

All  Member  States  already  achieved  the  first  stage  of  the  Directive’s  ambitious  strategy,  to 
produce,  in  the  EU,  only  second  or  higher  generation  purpose  bred  non-human  primates  for 
research purposes.  

Regular inspections  take place, including on average 40% unannounced inspections.  However, 
some  Member  States  still  do  not  reach  the  minimum  level  of  inspections  required  by  the 
Directive. 

For  the  first  time  in  the  EU,  the  number  of  animals  bred  and  killed  without  being  used  in 
procedures  were  provided  for  2017.  Together  with  the  annual  statistics,  this  indicates  the  total 
numbers of animals currently required to support EU research and testing, setting a baseline for 
measuring immediate and future efforts towards reducing the use of animals. 

As guardian of the Treaties and in line with its commitment in response to the European Citizens 
Initiative  “Stop  Vivisection”,  the  Commission  is  assessing  the  conformity  of  the  transposition 
into national legislation assertively. This resulted in the Commission services opening EU Pilots 
with all Member States. While some EU Pilots led to successful results, others were followed up 
by a formal infringement procedure launched by the Commission. For yet other Member States, 
12 

 
 
 
the assessment of their replies is ongoing. If non-compliance is identified, the Commission may 
launch further infringement procedures.  
The  review  of  the  Directive  (November  201713)  showed  problems  in  the  publication  of  non-
technical project summaries of authorised projects. The Commission then streamlined reporting 
obligations, amending the Directive through Regulation (EU) 2019/101014 in June 2019. These 
include setting up an open access, searchable central EU database for both non-technical project 
summaries and statistical  data hence significantly  improving transparency  of animal  use in  the 
EU and reducing administrative burden. 

In  addition,  the  Commission  has  prioritised  efforts  to  facilitate  implementation.  Together  with 
stakeholders,  the  Commission  developed  guidance  documents  addressing  key  concepts  in  the 
Directive, available in all 23 Union languages. The Commission is committed to continuing this 
work.  The  Commission  is  also  addressing  future  scientists  through  development  of  education 
and training tools focusing on alternatives to animal use.  

13 COM/2017/0631 final 
14 OJ L 170, 25.6.2019, p. 115–127 

13