REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL 2019 report on the statistics on the use of animals for scientific purposes in the Member States of the European Union in 2015-2017
Date: 2020-02-05
Institutions: Directorate-General for Environment, European Commission
Subjects: EU Member State, EU statistics, animal experimentation, animal welfare, data collection, database, national statistics, open data, protection of animals, scientific research

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 5.2.2020  COM(2020) 16 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL 2019 report on the statistics on the use of animals for scientific purposes in the Member States of the European Union in 2015-2017                 {SWD(2020) 10 final}  
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT 
AND THE COUNCIL 

2019 report on the statistics on the use of animals for scientific purposes in the 
Member States of the European Union in 2015-2017 

I. 

INTRODUCTION 

This  report  presents  statistical  data  on  the  use  of  animals  for  scientific  purposes  in  the 
Member  States  of  the  European  Union  during  the  years  2015  to  2017  under  Directive 
2010/63/EU1 (“the Directive”) on the protection of animals used for scientific purposes. 
The obligation of the Member States to collect statistical data is covered by Article 54(2) 
of the Directive. 

Regulation  (EU)  2019/10102  (“the  Regulation”)  amended  Article  54(2)  to  require 
Member States to submit the statistical data to the Commission by electronic transfer in a 
non-summarised  format.  As  the  Regulation  was  adopted  in  June  2019,  the  first  annual 
data  set  in  line  with  the  new  wording  of  Article  54(2)  will  be  collected  in  2020  and 
submitted to the Commission by 10 November 2021. That Member State data will then 
be made available through an open access database in 2022 accompanied by a summary 
report thereof.  

The  Regulation  also  removed  the  obligation  of  the  Commission  to  submit  a  statistical 
report  to  the  European  Parliament  and  the  Council.  However,  since  improved 
transparency is  one of the key objectives of the Directive, the Commission considers it 
appropriate, as well as necessary in support of the other objectives of the Directive, that 
the data submitted by the Member States is made available on a yearly basis until 2022.    

A more detailed Commission Staff Working Document3 accompanies this report. 

II. 

DATA SUBMITTED AND GENERAL ASSESSMENT 

II.1.  Data submitted by the Member States 

All  28  Member  States  submitted  data  for  the  years  2015  to  2017  according  to  the 
Commission Implementing Decision 2012/707/EU of 14 November 2012, establishing a 
format for the submission of the information pursuant to the Directive. 

The  individual  Member  State  data  and  narratives  can  be  found  in  Part  B  of  the  Staff 
Working Document.   

II.2.  Data outside of the scope of the report 

What remains outside of the scope of annual statistical reporting, even if covered by the 
scope of the Directive, are:  

a)  Foetal forms of mammals; 

1 Directive 2010/63/EU OJ L276, 20.10.2010, p.33-79   
2 OJ L 170, 25.6.2019, p. 115–127 
3 SWD(2020)10 final 

1 

 
 
                                                 
b)  Animals  killed  solely  for  organs  and  tissues,  and  sentinels,  unless  the  killing  is 
performed under a project authorisation using a method not included in Annex IV 
of Directive 2010/63/EU; 

c)  Animals  bred  and  killed  without  being  used,  apart  from  genetically  altered 
animals  with  intended  and  exhibited  harmful  phenotype,  and  those  having  been 
genotyped with an invasive method before being killed. 

The five-year report on the implementation of the Directive4 provides, in addition, for the 
year 2017, the number of animals bred and killed without being used in procedures. This 
allows,  now  for  the  first  time  and  once  every  five  years,  to  draw  a  total  picture  of  all 
animals needed to support research and testing in the EU.  

II.3.  Link to the previous statistical reports under Directive 86/609/EEC5 

It should be noted that this is the first report on animal use data collected according to the 
changed  reporting  requirements  under  the  Directive,  as  laid  out  in  Commission 
Implementing Decision 2012/707/EU. These requirements are significantly different and 
cover  areas  of  animal  use  that  were  not  included  under  the  previous  legislation.  It  is 
therefore not  possible, in general,  to  compare the detailed information  presented in  this 
report with earlier reports published under the previous Directive 86/609/EEC.  

With  this  in  mind,  the  only  limited  comparison  which  may  be  attempted  concern  the 
numbers  of  animals  used  for  the  first  time  for  the  purposes  of  research  and  testing6. 
However, even here the comparison is not obvious, because (1) invertebrate species were 
not included in the past reports and they are now, and (2) the previous numbers included 
partly  those  animals  that  were  used  for  the  creation  of  genetically  altered  animal  lines 
(which are now separate), leaving the comparison between 2011 and current numbers of 
animals only as an estimate.The main differences are summarised below: 

1.  The  scope  includes  new  classes  of  animals,  namely  all  species  of  Cephalopods.  In 
addition,  the  creation  and  maintenance  (breeding)  of  genetically  altered  animals  is 
covered; 

2.  The  time  of  reporting  -  the  information  is  submitted  when  a  use  of  an  animal  is 

completed, instead of at the start of the use; 

3.  Each use of an animal is captured, both the number of uses and details thereof;   

4.  Genetic status of the animals; 

5.  The actual severity experienced by an animal during a procedure is one of the key 

novelties of the new report. 

The data quality control revealed shortfalls but the overall assessment showed acceptable 
quality.  Some  elements  of  the  new  reporting  have  proven  extremely  demanding  and 
required  extensive  efforts  by  Member  States  and  the  Commission.  These  concern 
especially the reporting of the severities experienced by animals and the consistency of 
reporting  animal  use  for  the  maintenance  of  genetically  altered  animals  within  and 
between Member States, and over years. 

4 COM(2020)15 final 
5 OJ L 358 , 18/12/1986, p. 1-28 
6  “Research  and  testing”  covers  animals  used  for  research,  testing,  routine  production  and  education 

(including animals used for training purposes) 

2 

 
                                                 
In  addition  to  the  Severity  Assessment  Framework  guidance7  prepared  by  the 
Commission  together  with  stakeholders,  some  Member  States  have  been  particularly 
active  in  their  efforts  to  improve  data  quality.  Furthermore,  some  stakeholder 
organisations8 have offered workshops to address issues in severity reporting. With these 
and other efforts, the statistical data quality is expected to continue to improve. It is clear 
therefore, that some of the fluctuations in numbers, or even what may seem as trends at 
this  early  stage,  may  instead  be  due  to  improved  understanding  of  the  reporting 
obligations.  Finally,  for  these  same  reasons  it  is  too  early  to  draw  firm  conclusions  on 
trends on the basis of only the first three years of data. 

II.4.  Presentation of the data 

To step up the efforts in improving transparency of animal use in the EU, the statistical 
information  is  now  much  more  detailed  and  elaborated.  This  allows  for  a  much  better 
understanding of when and how animals are still used in science in the EU.  

It is hoped that, in line with the Directive aims, this will better facilitate the identification 
of  animal  use  areas  on  which  efforts  for  the  development  and  validation  of  alternative 
approaches should be focused.  

The report analyses the data in three distinctive areas: 

1.  Numbers  of  animals  used  for  research,  testing,  routine  production  and 
educational  (including  training)  purposes  (“research  and  testing”  from  here 
on).  These  animals  can  be  both  conventional  animals  or  those  that  are 
genetically altered. 

2.  Details  of  all  uses  (first  and  any  subsequent  reuse)  of  animals  for 
research  and  testing.  This  serves  to  draw  an  overall  picture  of  all  uses  of 
animals  for  the  purposes  of  research,  testing  and  takes  into  account  the 
nature  of  the  procedures,  their  legislative  context,  reuse  of  animals,  the 
genetic status of the animals, and the severities experienced by the animal. 

3.  Numbers  and  uses  of  animals  for  the  creation  and  maintenance  of 
genetically altered animal lines. The third section focuses on the provision 
of  genetically  altered  animals  needed  to  support  scientific  research  in  the 
EU.  These  animals  have  not  been  used  in  other  scientific  procedures, 
covered in sections one and two above. 

General  information  is  presented  for  the  three  years,  2015  –  2017.  A  more  detailed 
analysis, however, uses the most recent and likely most accurate data of 2017. 

7 https://ec.europa.eu/environment/chemicals/lab_animals/pubs_guidance_en.htm 
8  Federation  for  Laboratory  Animal  Science  Associations  (FELASA),  European  Society  for  Laboratory 
Animal Veterinarians (ESLAV) and European College of Laboratory Animal Medicine (ECLAM) 

3 

 
 
                                                 
III. 

RESULTS 

III.1.  Overall numbers of animals used in the EU 

Both the numbers of animals used for research and testing and those used for the creation 
and maintenance of genetically altered animal lines seem to indicate a downward trend in 
the EU. 

III.1.1.  Numbers of animals used for research and testing in the EU 

The  number  of  animals  used  for  the  first  time  (naïve  animals)  for  research  and 
testing in the EU is below 10 million animals annually.  

Between 2015 and 2017, the total number of animals decreased slightly from 9.59 
million (2015) to 9.39 million (2017). However, there was a slight increase to 9.82 
million in 2016, preventing the confirmation of a clear trend (Table 1). 

2015 

2016 

2017 

Total 

9,590,379 

9,817,946 

9,388,162 

Table 1: Total numbers of animals used for the first time for research, testing, routine 
production and education purposes 

III.1.2.  Numbers  of  animals  used  for  the  creation  and  maintenance  of  genetically 

altered animal lines in the EU 

The number of animals used for the first time (naïve animals) for the creation and 
maintenance of genetically altered (GA) animal lines to meet the research needs 
in the EU is around 1.2 million.  

Between  2015  and  2017,  despite  of  the  fact  that  the  creation  of  new  genetically 
altered  animal  lines  increased  by  7%,  the  total  numbers  of  animals  used  for  the 
creation  and  maintenance  of  genetically  altered  animals  showed  a  combined 
decrease  of  almost  20%.  However,  some  of  this  decrease  may  be  attributed  to  an 
increased  understanding  of  the  reporting  requirements  within  these  categories 
(Table 2).   

GA creation 

GA maintenance 

Total GA creation and 
maintenance 

2015 

591,033 

996,993 

2016 

493,156 

700,536 

2017 

634,705 

641,882 

1,588,025 

1,193,692 

1,276,587 

Table 2: Total numbers of animals used for the creation and maintenance of genetically altered 
animal lines 

4 

 
 
 
 
 
 
 
III.2.  Animals used for the first time in research and testing 

In 2017, the main species used for the first time in research and testing were mice, fish, 
rats  and  birds,  which  together  represented  92%  of  the  total  number  of  animals  while 
species of particular public concern (dogs, cats and non-human primates) represented less 
than 0.3% of the total number of animals. No Great Apes are used for scientific purposes 
in the EU (Fig. 1). 

Figure 1: Numbers of animals used for the first time by main classes of species in 2017 

Mice 

Rats 

Guinea-Pigs 

Hamsters (Syrian) 

Hamsters (Chinese) 

Mongolian gerbil 

Other rodents 

Rabbits 

Cats 

Dogs 

Ferrets 

Other carnivores 

Horses, donkeys and cross-breeds 

Pigs 

5 

2015 

2016 

2017 

5,711,612  5,989,413  5,707,471 

1,201,189  1,173,135  1,146,299 

149,328 

150,985 

144,824 

20,195 

18,614 

12,700 

30 

6,199 

26,088 

519 

5,645 

13,712 

187 

5,239 

25,172 

346,052 

350,405 

351,961 

1,975 

14,501 

2,212 

3,648 

3,217 

1,951 

15,691 

1,530 

1,444 

3,474 

1,879 

13,688 

2,016 

2,386 

2,414 

73,895 

80,029 

71,522 

 
 
 
 
 
 
Goats 

Sheep 

Cattle 

Prosimians 

Marmoset and tamarins 

Squirrel monkey 

Other species of New World Monkeys 
(Ceboidea) 

Cynomolgus monkey 

Rhesus monkey 

Vervets (Chlorocebus spp.) 

Baboons 

Other species of Old World Monkeys 
(Cercopithecoidea) 

Other mammals 

Domestic fowl 

Other birds 

Reptiles 

Rana 

Xenopus 

Other amphibians 

Zebra fish 

Other Fish 

Cephalopods 

Total 

2,233 

20,106 

26,763 

169 

429 

13 

0 

6,221 

211 

56 

37 

0 

1,365 

21,240 

22,782 

44 

285 

8 

0 

6,503 

318 

19 

62 

0 

1,563 

18,812 

30,643 

98 

465 

8 

3 

7,227 

353 

33 

25 

23 

9,535 

3,637 

26,335 

515,834 

500,920 

464,553 

119,377 

94,804 

99,410 

2,414 

4,884 

10,837 

20,190 

3,240 

4,482 

18,511 

19,558 

2,937 

3,485 

13,539 

10,683 

338,815 

513,011 

499,763 

936,252 

791,726 

719,932 

15,862 

8,884 

514 

9,590,379  9,817,946  9,388,162 

Table 3: Numbers of animals used for the first time by species 

Between  2015  and  2017,  in  reference  to  specific  groups  of  species,  the  number  of 
amphibians,  cephalopods,  reptiles  decreased  altogether  by  42%,  hamsters  by  37%, 
horses, donkeys and cross-breeds by 25% and birds by 11%. Also, the numbers of dogs (-
6%), cats (-5%), rats (-5%) and fish (-4%) decreased slightly. The numbers of sheep and 
goats decreased by 9% while the numbers of cattle increased (+14%). 

The numbers of non-human primates saw an increase of 15%. The cynomolgus monkey, 
representing 88% of non-human primates in 2017, was the most commonly used species 
of non-human primates and had an increase of 16% between 2015 and 2017. Numbers of 
marmosets,  rhesus  monkeys  and  other  old  world  monkeys  also  increased  slightly. 
Numbers of other non-human primate species decreased between 2015-2017. There was 
a small increase in the numbers of rabbits (+2%).  

III.2.1.  Origin of animals (other than non-human primates) 

The origin of animals is monitored as accommodation and care standards of the Directive 
only  apply  within EU.  Moreover, an increase in  transport times may impact  negatively 
welfare. In 2017, almost 90% of the animals used for scientific purposes were born in the 
EU at registered breeders and less than 2% were born outside of the EU (either in the rest 
of  Europe  or  outside  of  Europe).  The  category  'animals  born  in  the  EU  but  not  at  a 
registered  breeder'  includes  animals  from,  for  example,  farms,  and  studies  on  wild 
animals. 

6 

 
 
 
Between 2015 and 2017, animals born in the EU but not at a registered breeder decreased 
(-23%) and animals born outside of Europe increased (+60%) due to the import of bats 
(not bred in Europe). 

Figure 2: Place of birth of animals other than non-human primates in 2017 

III.2.2.  Source and generation of non-human primates 

The Directive provides additional protection for non-human primates (NHP) due to their 
genetic proximity to  human beings,  their highly developed social skills  and capacity to 
experience pain, suffering and distress. In order to end the capturing of animals from the 
wild including for the purposes of breeding, the Directive requires moving towards using 
NHPs  that  have  been  bred,  ultimately,  in  self-sustaining  colonies,  from  parents  who 
themselves have been bred in captivity. 

In  2017,  the  three  main  sources  of  NHP  were  Africa,  Asia  and  EU-registered  breeders 
(Table 4). 

Animals born at a 
registered breeder 
within EU 

Animals 
born in rest 
of Europe 

Animals 
born in Asia 

Animals 
born in 
America 

Animals 
born in 
Africa 

Animals 
born 
elsewhere 

F19 

3% (32) 

0% (0) 

3% (88) 

30% (16) 

27% (1,147) 

47% (80) 

9 F1: first generation purpose-bred animals; F2: second (or higher) generation purpose-bred animals, 

7 

 
 
 
 
 
 
 
                                                 
F2 or greater 

Self-sustaining colony 

Total 

40% (418) 

57% (607) 

100% 

(1,057) 

100% (5) 

75% (1,948) 

70% (38) 

44% (1,915) 

26% (44) 

0% (0) 

100% 

(5) 

22% (578) 

100% 

(2,614) 

0% (0) 

100% 

(54) 

29% (1,273) 

27% (46) 

100% 

(4,335) 

100% 

(170) 

Table 4: Generation of non-human primates by source in 2017 

In 2017, cynomolgus monkeys represented 88% of NHPs used for the first time and were 
coming almost entirely from outside of the EU. On the contrary, other species of NHPs 
were mainly coming from EU registered breeders. 

With  regard  to  the  generation,  the  majority  of  NHPs  was  coming  either  from  self-
sustained colonies (30%) or being second or higher generation purpose-bred (53%).  

Between  2015  and  2017,  NHPs  coming  from  self-sustained  colonies  remained  stable. 
However, in line with the Directive objectives, those being second or higher generation 
purpose-bred  increased  significantly  (+67%).  None  of  the  NHPs  used  for  the  first  time 
was captured from the wild in 2017. 

III.3.  All uses of animals for research and testing 

Between 2015 and 2017, the total number of uses (first use and any subsequent reuse) for 
research and testing decreased by 2% from 9.78 million in 2015 to 9.58 million uses in 
2017. However, there was an increase to 10.03 million in 2016 (Table 5). 

2015 

2016 

2017 

Total  9,782,570  10,028,498  9,581,741 

Table 5: Total number of uses of animals in research and testing between 2015 and 2017 

III.3.1. Main categories of scientific purposes 

In  2017,  9.58  million  uses  of  animals  for  scientific  purposes  were  reported.  The  main 
purpose was research (69%) of which 45% of all uses were carried out for basic research 
and 23% for translational and applied research purposes. A further 23% of animal uses 
were  for  regulatory  use  to  satisfy  legislative  requirements,  followed  by  routine 
production (5%). 

Other categories are protection of the natural environment in the interest of the health or 
welfare of human beings or animals, preservation of species, higher education or training 
for  the  acquisition,  maintenance  or  improvement  or  vocational  skills  and  forensic 
enquiries (Fig. 3). 

8 

 
 
 
 
 
 
 
Figure 3: All uses of animals for research and testing in 2017 

III.3.2. Severity of all uses in research and testing 

The Directive requires the reporting of the actual severity experienced by an animal when 
used in a procedure.  

In 2017, 51% of uses were assessed as ‘mild’ (up to and including), 32% as ‘moderate’, 
11% as ‘severe’ and 6% of uses were ‘non-recovery10’. The number of severe procedures 
increased  proportionally  between  2015  and  2016  mainly  because  of  an  increase  in  the 
uses  for  disease  diagnosis  (Table  6).  The  proportion  of  severe  uses  remained  the  same 
between 2016 and 2017. 

10 Animals which have undergone a procedure that has been performed entirely under general anaesthesia 

from which the animal has not recovered consciousness. 

9 

 
 
 
                                                 
It  is  important  to  note  that  the  reporting  of  actual  severities  is  probably  the  most 
challenging element  to  achieve consistent reporting within and between  Member States 
as well as over time. Therefore, any firm conclusions on the results of these early years 
of reporting should be discouraged.  

Non-recovery 

6% (622,034) 

6% (620,848) 

6% (621,054) 

Mild [up to and including] 

54% (5,330,549) 

52% (5,239,321) 

51% (4,865,721) 

2015 

2016 

2017 

Moderate 

Severe 

Total 

31% (3,010,980) 

31% (3,101,054) 

32% (3,071,828) 

8% (819,007) 

11% (1,067,275) 

11% (1,023,138) 

100% (9,782,570)  100% (10,028,498)  100% (9,581,741) 

Table 6: Severity of uses 

When analysing all the sub-categories of purposes, batch potency testing resulted in the 
highest number of severe uses (over 264K uses), followed by studies on nervous system 
(over 87K uses) and diagnosis of diseases (over 81K) (Fig. 4).  

Figure 4: Severe uses of animals for research and testing in 2017 

10 

 
 
 
Looking  at  the  proportion  of  severe  uses  within  a  sub-category:  production  of 
monoclonal antibodies by ascites method was the highest (70% of uses for this purpose 
were  severe  –  Fig.  10),  followed  by  diagnosis  of  diseases  (54%  -  Fig.  6)  and  acute 
toxicity studies in the area of ecotoxicity (37% - Fig. 8). 

When  analysing  sub-categories  with  more  than  30K  uses,  the  lowest  severities,  (i.e. 
severe  uses  representing  less  than  1%  of  all  uses  within  that  sub-category,)  are  the 
production of blood based products (Fig. 11), preservation of species (Fig. 4),  education 
and training (Fig. 4) and toxicity testing for skin sensitisation (Fig. 8). 

III.3.3. Uses of animals for research purposes 

Research-related uses are split between basic research on one side and translational and 
applied research on the other. 

Basic research accounted for more than 4.3 million uses in 2017. The four main domains 
of  basic  research  are  nervous  system,  immune  system,  oncology  and  ethology/animal 
behavior  /  animal  biology  that  overall  account  for  more  than  half  of  the  uses  in  basic 
research (Fig. 5). 

11 

 
 
 
 
 
Figure 5: Basic research related uses by type of research and severity in 2017 

Translational  and  applied  research  accounted  for  about  2.2  million  uses  of  animals  in 
2017.  The  four  main  areas  of  such  research  were  human  cancer,  human  nervous  and 
mental disorders, human infectious disorders and animal diseases and disorders (Fig. 6). 

12 

 
                            
 
 
Figure 6: Translational and applied research related uses by type of research and severity in 2017 

III.3.4. Uses of animals for regulatory purposes   

In 2017, regulatory uses accounted for 2.18 million uses. 52% of these uses were related 
to quality control (including batch safety and potency testing), 39% to toxicity and other 
safety  testing  including  pharmacology  and  the  remainder  (9%)  were  for  other  efficacy 
and tolerance testing. Quality  control related uses represented 1.1 million uses. A large 
majority of these uses were related to batch potency testing purposes (79%) (Fig. 7). 

13 

 
 
                                                                      
 
Figure 7: Quality Control related uses by type and severity in 2017 

Toxicity  and  other  safety  testing  including  pharmacology  represented  more  than  800K 
uses of animals, which represented 8% of all animal uses (Fig. 8). 

14 

 
 
 
 
Figure 8: Toxicity and other safety testing including pharmacology by type of use and severity in 
2017 

Most of the uses in this area were related to reproductive toxicity, repeated dose toxicity, 
pharmaco-dynamics,  developmental  toxicity,  ecotoxicity  and  acute  and  sub-acute 
toxicity. 

15 

 
                
 
III.3.5. Regulatory uses by legislation 

In  2017,  the  majority  of  uses  to  satisfy  requirements  of  specific  sector  legislation 
occurred for medicinal products for humans (61%), veterinary medicinal products (15%) 
and industrial chemicals (11%) (Fig. 9). 

Between 2015 and 2017, the uses to satisfy legislative requirements for medical products 
for human use decreased by 13% while those related to medical device legislation uses 
(+23%) and industrial chemicals legislation uses (+17%) saw an increase. No uses were 
reported under the cosmetics legislation. 

In 2017, the majority of regulatory uses was performed to satisfy regulatory requirements 
originating  from  the  EU  (95%).  Non-EU  requirements  accounted  for  4%  and  national 
requirements for 1%. 

Figure 9: Regulatory uses by type of legislation in 2017 

Between 2015 and 2017, the total number of uses for regulatory purposes decreased by 
7%. 

16 

 
 
 
 
III.3.6. Uses of animals for routine production  

In 2017, there were about 450K routine production uses which represented 5% of all uses 
of animals. 55% of these were related to the production of blood-based products and 10% 
to monoclonal antibodies production by the mouse ascites method (Fig. 10). 

Figure 10: Routine production uses by product type and severity in 2017 

III.3.7. Reuse of animals 

In line with the principle of the Three Rs, the total number of animals used in procedures 
can be reduced by performing more than one procedure on an animal. However, reuse of 
animals is permitted only under specific conditions related to the actual level of severity 
the animal has experienced in a previous procedure and the health and well-being of the 
animal,  taking  into  account  the  lifetime  experience  of  the  individual  animal.  The  reuse 
cannot be authorised for a procedure that is prospectively classified as severe. 

2% of all uses were reported as reuses (Table 7).  

2015 

2016 

2017 

No 

Yes 

98% (9,590,379) 

98% (9,817,946) 

98% (9,388,162) 

2% (192,191) 

2% (210,552) 

2% (193,579) 

Total  100% (9,782,570)  100% (10,028,498)  100% (9,581,741) 

Table  7:  Reuses  of  animals  used  for  research,  testing,  routine  production  and  educational 
purposes 

In absolute numbers, the main species reused for scientific purposes in 2017 were mice, 
sheep, rats, rabbits, horses, donkeys and cross-breeds. 

17 

 
 
            
 
 
 
 
 
 
Proportionally,  large  mammals  are  more  often  reused,  e.g.  horses,  donkeys  and  cross-
breeds  (82%),  sheep  (71%),  cats  (44%),  dogs  (36%)  and  cynomolgus  monkeys  (28%). 
Reptiles (55%) and xenopus (37%) amongst amphibians were also often reused. 

In terms of the purposes of reuse, in 2017, routine production had the largest proportion 
of reuses (12%) mainly for blood-based products. This was followed by higher education 
or training of vocational skills (8%). 

In 2017, most of the actual experienced severities of reuse were mild (74%) or moderate 
(19%),  with  6%  reported  as  non-recovery.  Even  if  the  procedure  is  prospectively 
classified in a lower severity category, an individual animal may reach severity category 
"severe"  due  to  unexpected  events  occurring  during  the  procedure.  Only  0,2%  was 
assessed as severe. 

III.3.8. Genetic status of animals 

In 2017, 2.59 million uses for the purposes of research were carried out on animals that 
were  genetically  altered,  of  which  17%  exhibited  a  harmful  phenotypic  alteration  (Fig. 
11).  

The  number  of  genetically  altered  animals  among  all  animal  uses  for  research  is 
increasing  slightly.  Between  2015  and  2017,  the  percentage  of  genetically  altered 
increased  from  25%  to  27%.  In  2017,  2.57  million  of  the  9.38  million  animal  uses 
involved  genetically  altered  animals.  Zebra  fish  and  mice  were  the  most  common 
genetically altered species with 64% and 38% of them genetically altered respectively. 

Figure 11: Genetic status of animals used in research and testing in 2017 

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Genetically altered animals  are used almost  exclusively for research purposes.  In 2017, 
basic research accounted for 75% of uses of genetically altered animals and translational 
and applied research for 21%. 

III.4.  Creation  and  maintenance  of  genetically  altered  animal  lines  for  research 

purposes 

III.4.1. Creation of new genetically altered animal lines 

In 2017, 658K animal uses were carried out for the purposes of creating new genetically 
altered  animal  lines.  The  main  species  used  for  this  purpose  were  mice  and  zebra  fish, 
75% and 23% respectively. Other species, although in small numbers, include rats, other 
species of fish, domestic fowl, rabbits, xenopus and pigs. In 2017, the use of genetically 
altered non-human primates (marmosets) was reported for the first time in the EU. 

In  2017,  95%  of  the  new  genetically  altered  lines  were  created  for  purposes  covered 
under basic research; 22% concerned multisystemic research (where more than one body 
system is the primary interest of the research, such as in some infectious diseases), 15% 
nervous  system,  13%  oncology  and  11%  cardiovascular,  blood  and  lymphatic  system. 
The most important sub-category under translational and applied research for which new 
genetically altered animal lines were created was human cancer (27%).  

Mice 

Zebra fish 

Rats 

Other Fish 

Domestic fowl 

Rabbits 

Xenopus 

Pigs 

Other Mammals 

Sheep 

Marmoset and tamarins 

Guinea-Pigs 

Other Rodents 

Total 

2015 

2016 

2017 

477,783  359,894  490,717 

124,359  122,082  150,596 

6,039 

10,737 

9,960 

4,569 

4,381 

2,556 

279 

272 

515 

967 

7,259 

1,100 

350 

4 

31 

0 

0 

0 

284 

0 

191 

0 

47 

6 

647 

475 

250 

227 

61 

17 

10 

0 

0 

617,274  501,862  657,529 

Table 8: Uses of animals for the creation of new genetically altered animal lines by species 

III.4.2. Maintenance  of  colonies  of  established  genetically  altered  animal 

lines 

This  category  contains  animals  required  for  the  maintenance  of  colonies  of  genetically 
altered animals of established lines with an intended harmful phenotype and which have 
exhibited  pain,  suffering,  distress  or  lasting  harm  as  a  consequence  of  the  harmful 
genotype  before  being  killed.  It  also  includes  genetically  altered  animals  during 
maintenance of an established line, irrespective of whether the line is of non-harmful or 

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harmful phenotype, for which the genotype has been confirmed using an invasive method 
of tissue sampling. 

The  uses  of  animals  for  this  purposes  decreased  significantly  between  2015  and  2017, 
from 1 million to 0.6 million respectively. In 2017, 642K uses were reported under the 
maintenance of colonies. Amongst these animals, 74% were genetically altered without a 
harmful phenotype, 20% with a harmful phenotype and 6% without genetic alteration. 

Given the complexity of the new reporting obligations in this area, errors in reporting are 
still being detected. In addition, some Member States apply different reporting rules for 
their national reporting which may have resulted in incoherent reporting for EU purposes. 
The Commission is working together with Member States to improve the situation.  

IV. 

CONCLUSIONS 

The  EU  has  significantly  improved  the  transparency  with  the  new,  detailed  statistical 
data.  The  number  of  animals  reported  in  2011  were  almost  11.5M.  The  number  of 
animals used in research and testing reported in 2015, 2016 and 2017 is below 10M, with 
a  decrease  also  continuing  between  2015  and  2017.  Although  it  is  not  possible  to 
compare the details to previous reports due to several changes to the reporting rules, the 
results  nevertheless  would  suggest  a  clear  positive  development.  Mice,  fish,  rats  and 
birds,  together  represent  over  92%  of  the  total  numbers  of  animals.  The  use  of  most 
common species of non-human primates increased between 2015 and 2017, whereas the 
use of dogs and cats decreased slightly. 

The new reporting requirements allowed to  confirm  a good progress  with  the Directive 
requirements  under  Article  10,  with  more  than  50%  of  the  non-human  primates  now 
being  second  or  higher  generation  purpose-bred.  No  non-human  primates  were  coming 
from the wild in 2017. 

The main areas of animal uses remain unchanged, with most uses being in basic research 
(45%), followed by translational/applied research (23%) and regulatory use (23%).  

There  is  a  concern  with  the  uses  of  animals  in  areas  where  alternative  methods  have 
reached regulatory acceptance (for example in  areas of skin  irritation/corrosion, serious 
eye  damage/eye  irritation  and  pyrogenicity  testing),  which  requires  further  attention  by 
the authorities authorising projects for these use purposes.  

The  new  requirement  to  report  actual  experienced  severity  allows  focusing  efforts,  not 
only  on  areas  with  the  highest  numbers  of  animal  uses,  but  also  on  those  with  most 
severe  impact  on  animals.  Where  replacement  is  not  yet  scientifically  feasible,  efforts 
should be made to refine these uses. In general, however, over 50% of all uses in research 
and testing are of mild severity. 

Animal reuse has contributed to some reduction of the total number of animals used for 
scientific purposes. On average 2 % of all animals used have been reused. However, the 
benefits of reuse against cumulative harm to the animal must always be judged on a case 
by case basis. 

Genetically  altered  animals  used  for  research  purposes  are  mostly  mice  and  zebra  fish. 
Their  use  has  slightly  increased  as  has  the  creation  of  new  genetically  altered  animal 
lines. Uses reported under the maintenance of genetically altered animals decreased. 

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