Report from the Commission to the Council and the European Parliament - fourth Report on the statistics on the number of animals used for experimental and other scientific purposes in the Member States of the European Union {SEC(2005) 45} ..
Date: 2005-01-20
Institutions: European Commission
Subjects: EU statistics, animal experimentation, report, research method

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 20.1.2005 
COM(2005) 7 final 

. 

REPORT FROM THE COMMISSION TO THE COUNCIL  
AND THE EUROPEAN PARLIAMENT 

FOURTH REPORT ON THE STATISTICS ON THE NUMBER OF ANIMALS USED 
FOR EXPERIMENTAL AND OTHER SCIENTIFIC PURPOSES IN THE MEMBER 
STATES OF THE EUROPEAN UNION 

{SEC(2005) 45} 

.. 

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TABLE OF CONTENTS 

I. INTRODUCTION .................................................................................................................. 3 

II. 

DATA SUBMITTED AND GENERAL ASSESSMENT........................................... 4 

II.1. Data submitted by the Member States................................................................................ 4 

II.2. General assessment............................................................................................................. 4 

III. RESULTS............................................................................................................................. 5 

III.1.  Results from EU Table 1: Species and number of animals used ................................. 5 

III.2. 

Further results from EU Table 1: Origin of animals used............................................ 6 

III.3.  Results from EU Table 2: Purposes of the experiments .............................................. 7 

III.4.  Results from EU table 3: Toxicological or safety evaluation for type of 

products/endpoints ....................................................................................................... 8 

III.5.  Results from EU table 4: Animals used for studies of diseases................................... 8 

III.6.  Results from EU Table 5: Animals used in production and quality control 

of products for human medicine and dentistry and for veterinary medicine ............. 10 

III.7.  Results from EU harmonized Table 6: Origin of regulatory requirements for 

animals used in toxicological and other safety evaluations ....................................... 11 

III.8.  Results of EU Table 7: Animals used in toxicity test for toxicological or 

other safety evaluations.............................................................................................. 12 

III.9.  Results of EU Table 8: Type of toxicity tests carried out for toxicological or 

other safety evaluations of products........................................................................... 13 

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I. INTRODUCTION 

The  objective  of  this  Report  is  to  present  to  the  Council  and  to  the  European  Parliament 
statistics on the number of laboratory animals used in the EU, in accordance with Article 26 
of Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and 
administrative provisions of the Member States regarding the protection of animals used for 
experimental and other scientific purposes1. 

Three Reports have been published so far: 

–  The first Report2, published in 1994, covered data on animals used in the year 1991; 

–  The second Report3 was published 1999 and covered the data from 19964; 

–  The third Report5 was published in 2003 and covered the data from 1999. 

The data in the first Report were quite mixed, since the Directive provides only little detail on 
the  reporting  requirements.  However,  a  set  of  eight  statistical  standard  reporting  tables  (EU 
Tables)  was  agreed  between  the  Commission  services  and  the  competent  authorities  of  the 
Member  States  during  the  compilation  period  of  the  second  Report.  A  few  Member  States 
used these Tables already for their reporting to the second Report. 

For the third Report fourteen Member States submitted their data in accordance with the EU 
Tables, only one Member State used a different format because an amendment regarding data 
reporting was still needed in the existing federal law. 

For  the  present  fourth  Report,  all  fifteen  Member  States  used  the  agreed  EU  Tables.  Data 
were collected in 2002 with the exception of one Member State who collected data in 2001. 

This Report is accompanied by a “Commission Staff Working Paper - Report on the Statistics 
on  the  Number  of  Animals  used  for  Experimental  and  other  Scientific  Purposes  in  the 
Member  States  of  the  European  Union  in  the  year  2002”  (SEC  (2004)  XXX).  The  Staff 
Working Paper provides more details and also includes data from the single Member States 
and  their  respective  comments.  However,  all  conclusions  at  EU  level  are  fully  presented  in 
this Report. 

1 
2 
3 
4 
5 

OJ L 358, 18.12.1986, p. 1. 
COM(1994) 195 final. 
COM(1999) 191 final. 
including 1997 data from France. 
COM(2003) 19 final. 

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II.  DATA SUBMITTED AND GENERAL 
ASSESSMENT 

II.1. Data submitted by the Member States 

For  the  first  time  all  Member  States  used  the  agreed  EU  Tables  to  submit  their  data.  Data 
were collected in 2002, except for France who reported data from 2001. 

Member States in most cases applied a quality control check. This check greatly improved the 
coherence of the data amongst the different Tables. 

II.2. General assessment 

The main difference with the previous Reports is that the data now cover the complete range 
of  procedures  and  their  purposes.  This  allows,  for  the  first  time,  for  a  more  precise  and 
comprehensive picture at EU level. 

Data  are  far  more  coherent  amongst  the  different  Tables  than  in  previous  Reports. 
Nevertheless,  for  the  next  Report  coherence  still  needs  to  be  improved.  In  this  regard,  the 
accession of the ten new Member States will require additional efforts. 

Data analysis in this Report could be extended to all eight EU Tables, thanks to the exclusive 
use of the EU Tables for data submission. 

Results  in  this  Report  were  compared  with  previous  Reports.  However,  comparisons  were 
limited, because previous Reports were compiled on the basis of non-standard data. 

In addition, where comparisons are made in this Report, readers should note that one Member 
State (France) reported data from 1997 and 2001 (for the third and fourth Reports) whereas 
the other Member States reported from 1996 and 2002, respectively. Nevertheless, assuming 
that fluctuations in the annual numbers of animals used in a country are limited, it is safe to 
make semi-quantitative estimates of the observed trends. 

The total number of animals used for experimental and other scientific purposes in 2002 was 
10.7  million  (with  data  from  France  from  2001).  This  indicates  an  increase  beyond  the  9.8 
million counted in 1999, but it is still a decrease compared to the 11.6 million of 1996. 

By far the biggest group of animals used was rodents and rabbits, as in the previous Reports. 
A significant increase in the use of fish has made the group of cold-blooded animals account 
for over 15 % of all animals used. 

Readers should note  that the numbering of tables and figures in this Report is linked to  the 
numbers  of  the  EU  Tables  and  not  to  the  numbering  of  the  chapters  of  the  Report. 
Furthermore,  the  numbering  of  tables  and  figures  in  the  Report  is  coherent  with  the 
numbering in the above-mentioned Commission Staff Working Paper. 

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III. RESULTS 

III.1.  Results from EU Table 1: Species and number of animals used 

The  total  number  of  animals  used  in  the  EU  Member  States  in  2002  (France  reporting  for 
2001) was 10.7 million. Mice (51 %) and rats (22 %) were by far the most used species (fig. 
1.1). Rodents and rabbits together represented more that ¾ of all animals used (78 %). Cold-
blooded animals (15 %) were used much more than compared to the previous report (6.6 %). 
The  Artio  and  Perissodactyla  group 
including  horses,  donkeys  and  cross-breds 
(Perrisodactyla),  pigs,  goats,  sheep  and  cattle  (Artiodactyla)  represented  only  1.2  %. 
Carnivores represented 0.3 % of the total number of animals used and primates represented 
0.1 %. 

Figure 1.1
Classes of animals

Guinea-Pigs 2,11%

Other rodents  1,04% Rabbits 2,49%

Rats 21,5%

Mice 50,9%

Cold-blooded animals 
15,4%

Birds 4,99%

Artio+perissodactyla 
1,18%

Carnivores 0,28%

Prosimians+Monkeys
+Apes 0,10%

Other mammals 
0,03%

Comparison with previous years 

In 2002 the total number of animals used increased by about 917,000 (9.3 %) with regard to 
1999  (table  1.3).  The  increase  was  mainly  due  to  the  additional  use  of  about  970,000  fish 
(while other animal species decreased), raising the total of fish to almost 1.6 million. 

The  proportion  of  rodents  and  rabbits  used  throughout  1996,  1999  and  2002  shows  some 
fluctuation  around  80  %  (table  1.3).  For  cold-blooded  animals  the  proportion  used  in  1996 
and 2002 is about 14 %, with a significant low in 1999 of 7 %. 

Furthermore,  the  number  of  rats  and  guinea-pigs  decreased  from  1999  to  2002  (data  not 
shown  here).  There  was  only  a  relatively  low  increase  in  the  use  of  mice  but  a  more 
pronounced increase in the number of rabbits. The use of old world monkeys increased, too. 
However, in 2002 no great apes were used. - Although one Member State reported new and 

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old world monkeys together in 1999,  one can nevertheless make the qualitative observation 
that in 2002 there was a decrease in the use of new world monkeys.  

An  increase  was  similarly  observed  in  the  number  of  sheep,  cattle  and  the  number  of  other 
birds  than  quails  used  in  2002  in  comparison  to  1999.  Goats  on  the  other  hand  indicate  a 
decrease. 

Table 1.3: Comparison between the numbers and proportions of classes of animals used 
in 1996, 1999 and 2002 

Total  number  of  animals 
used 
% Rodents-rabbits 
% Cold-blooded animals 

1996 

11,646,130 *

1999 

2002 

9,814,171

10,731,020 ** 

81.3
12.9

86.9 
6.6 

78.04 
15.4 

* 
** 

14 Member States reporting for 1996, one for 1997 
14 Member States reporting for 2002, one for 2001 

III.2.  Further results from EU Table 1: Origin of animals used 

Although the origin only has to be reported for selected animal species, it is evident that the 
majority of the species in 2002 originated from the EU (fig. 1.2). However, for certain species 
(shown  on the  right side of the  graph) there was a clear shift towards non-European  origin. 
Note that in 2002 no apes were used. 

F ig u re  1 .2 :   O rig in  o f s p e c ie s

100%

80%

60%

40%

20%

0%

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Comparison with 1999 

In comparison with 1999 there was an increase in the proportion of new world monkeys and 
quails  of  European  origin.  In  contrast  to  this,  there  was  a  decrease  of  the  proportion  of 
hamsters and old world monkeys of European origin.  

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III.3.  Results from EU Table 2: Purposes of the experiments 

In  2002  more  than  60  %  of  animals  were  used  in  research  and  development  for  human 
medicine, veterinary medicine, dentistry and in fundamental biology studies (fig. 2.1). About 
16 % were used in production and quality control of products and devices in human medicine, 
veterinary  medicine  and  dentistry,  and  about  10  %  for  toxicological  and  other  safety 
evaluation. 

Figure 2.1
Purposes of experiments 

Education and training
 3,2%
Diagnosis of disease 
2,12%

Other 5,57%

Toxicological and other 
safety evaluation 9,93%

Production and quality 
control veterinary 
medicine 2,47%

Production and quality 
control human 
medicine and dentistry 
13,6%

Fundamental biology 
studies 34,7%

Research and develop 
human medicine 
+veteri+dentistry 28,4%

Comparison with previous years  

The percentage of animals used for research, development and quality control in the areas of 
human medicine, dentistry and veterinary medicine reached a high of 52 % in 1999, but was 
about  45  %  in  the  other  years  (table  2.3).  For  fundamental  biology  studies  the  percentage 
increased from 25 % to 35 % since 1996. By comparison, the percentages of animals used for 
toxicological and safety evaluation remained very stable at about 10 %. 

Table 2.3: Comparison between the relative percentages of animal used for selected 
purposes in 1996, 1999 and 2002 

Purpose 
Research, development and quality 
control in human medicine, veterinary 
medicine and dentistry  
Fundamental biology studies  
Toxicological and safety evaluation 

* 
13 Member States reported purposes of experiments 
**  14 Member Sates reported purposes of experiments 

1996 * 
44% 

1999 ** 
52% 

2002 
44.5% 

25% 
9% 

30% 
10% 

35% 
9.9% 

With regard to selected species used for selected purposes, the global pattern (not illustrated 
here)  has  not  changed  much  since  1999  (N.B.:  Such  data  was  not  reported  by  Germany  in 
1999), except for an increase of 27 % of the number of mice used in biological studies and for 
an  average  increase  of  about  14  %  of  the  number  of  cold-blooded  animals  used  for 

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fundamental  biological  studies,  for  research  of  products  in  human  medicine,  dentistry  and 
veterinary science, for toxicological evaluation and also for education and training. 

Diagnosis of disease 

The diagnosis of diseases is important in the light of epidemics of farm animals such as mad 
cow disease, foot and mouth disease and swine fever. 

Since 1999 the percentage of rodents and rabbits used has increased from 79 % to 91 %, the 
use of cold-blooded animals decreased from 15 % to 1 %. The use of other animals did not 
change notably. 

III.4.  Results  from  EU  table  3:  Toxicological  or  safety  evaluation  for  type  of 

products/endpoints 

Only  10  %  of  the  total  number  of  animals  used  for  experimental  purposes  were  used  for 
toxicological and other safety evaluation. From these 10 %, 51 % were used for products or 
devices used for human medicine, veterinary medicine and dentistry (fig. 3.1), and only 2.1 % 
were  used  for  the  toxicological  evaluation  of  animal  feed,  additives  for  human  food 
consumption, cosmetics and household. 

The group of products/substances falling under the scrutiny of authorities concerned with the 
safety of health and the environment from chemical products, such as industrial chemicals and 
pesticides, used 24 % of the animals for toxicological and other safety evaluations. 

Comparison with 1999 

The proportion of animals used for toxicological and other safety evaluation of products to be 
used  mainly  in  industry  and  agriculture  has  increased  from  19  %  to  24 %.  Similarly,  the 
proportion  of  animals  used  for  the  evaluation  of  potential  or  actual  contaminants  in  the 
general environment has increased form 7 % to 12 %. 

III.5.  Results from EU table 4: Animals used for studies of diseases 

In  2002  the  number  of  animals  used  for  studies  of  diseases  of  both  humans  and  animals 
represented 58 % of the total number of animals used for experimental purposes (fig. 4.1). 

Comparison with the data of 1999 

In  2002  the  pattern  of  study  diseases  was  similar  to  that  observed  in  1999,  except  for  an 
increase (from 10 to 15 %) of the proportion of animals used to study specific animal diseases 
and a marked decrease from (50 to 42 %) of the proportion of animals used for studying other 
human diseases. 

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Figure 3.1   Animals used in toxicological or other safety 

evaluations of products

3.7    Products/ 
substances used or 
intended to be used 
mainly as additives in 
food for human 
consumption
1,2%

3.8    Products/ 
substances used or 
intended to be used 
mainly as additives in 
food for animal 
consumption
0,3%

3.9   Potential  or actual 
contaminants in the 
general environment 
which do not appear in 
other columns
12,4%

3.6    Products/ 
substances used or 
intended to be used 
mainly as cosmetics or 
toiletries
0,25%

3.5   Products/ 
substances used or 
intended to be used 
mainly in the household
0,4%

3.4   Products/ 
substances used or 
intended to be used 
mainly in industry
12,75%

3.3     Products/ 
substances used or 
intended to be used 
mainly in agriculture
11,5%

3.10    Other  
toxicological or safety 
evaluations
10,3%

3.2    Products/ 
substances or devices 
for humanmedicine and 
dentistry and for 
veterinary medicine
50,7%

Figure 4.1
Proportion of animals used in studies of diseases

Specific animal 
diseases
14,5%

Human 
Cardiovascular 
diseases
7,3%

Human nervous 
and mental 
disorder
23,8%

Human cancer 
(excl. evaluation of 
carcino hazards)
12,6%

Other human 
diseases
41,9%

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The relative percentage of animals used for studies on diseases is shown in figure 4.2. Birds 
and  cold-blooded  animals  were  used  to  more  than  80  %  for  studies  on  specific  animal 
diseases. Some Member States indicated that both birds and fish were used for the purpose of 
vaccine testing, others could not confirm this. 

The pattern has not significantly changed since 1999 except for an increase in the percentage 
of use of cold-blooded animals for studies of animal diseases (from 56 to 80 %). 

Figure 4.2
Species of animals used in studies of diseases

100%

80%

60%

40%

20%

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Specific animal
diseases  

Other human
diseases 

Human cancer
(excl. evaluation of
carcino hazards) 
Human nervous
and mental
disorder 
Human
Cardiovascular
diseases

III.6.  Results  from  EU  Table  5:  Animals  used  in  production  and  quality  control  of 
products for human medicine and dentistry and for veterinary medicine  

The  number  of  animals  used  in  production  and  quality  control  of  products  for  human 
medicine and dentistry and for veterinary medicine represented 16 % of the total number of 
animals used for experimental purposes. Figure 5.1 gives the percentages of the animals used 
for different regulatory purposes in this area. 

The  largest  proportion  (43  %)  of  animals  in  this  area  was  used  to  simultaneously  satisfy 
requirements from several legislations (national, Community, Council of Europe, and others). 
Some  21  %  of  the  animals  were  not  required  for  any  regulatory  purposes.  To  explain  this 
relatively high proportion Member States reported a range of reasons, such as early stages in 
developmental processes or pilot studies, or additional tests to confirm earlier ambiguous test 
results.  Member  States  also  considered  that  some  unclear  data  reporting  may  have  been  a 
reason. 

Remark: In 1999 the data provided by the Member States for EU Table 5 showed too much 
variability.  Therefore,  no  interpretation  of  the  data  was  possible,  and  consequently  no 
comparison is possible now.  

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Figure 5.1:  Percentage of  animals used for regulatory requirements 
in the production and quality control of products and devices for 
human medicine and dentistry and for veterinary medicine

0.00

10.00

20.00

30.00

40.00

50.00

5.2     National legislation specific to a single EC Member
State

3.66

5.3     EC legislation including European Pharmacopoeia
(requirements)

31.27

5.4     Member Country of Council of Europe (but not EC)
legislation

0.04

5.5    Other legislation

1.34

5.6      Any combination of 5.2/ 5.3/ 5.4/ 5.5

43.12

 5.7       No regulatory requirements

20.51

III.7.  Results  from  EU  harmonized  Table  6:  Origin  of  regulatory  requirements  for 

animals used in toxicological and other safety evaluations 

The  use  of  animals  for  regulatory  requirements  in  the  area  of  toxicology  and  other  safety 
evaluations  (fig.  6.1)  follows  a  similar  pattern  to  that  of  the  use  for  regulatory  purposes  in 
human medicine, dentistry and in veterinary medicine (fig. 5.1). 

Comparison with 1999  

Animals  used  to  simultaneously  satisfy  regulatory  requirements  from  several  legislations 
covered over half of the animal used in this area and have basically remained at the same level 
(about 55 %).  

The  testing  to  satisfy  national  legislation  specific  to  a  single  Member  State  related,  for 
example,  to  national  health  and  safety  requirements  at  the  work  place.  Testing  for  such 
purposes appears to have increased from 6 % to 11 %, but Member States considered that this 
effect might partly be due to the complexity of data collected from the reporting institutions. 

Contrary  to  the  animals  used  in  the  areas  of  human  medicine,  dentistry  and  in  veterinary 
medicine (fig. 5.1), the proportion of animals attributed to “no regulatory requirement” in the 
area of toxicology and other safety evaluations appears to have decreased from 15 % to 11 %. 
Member  States  reported  a  number  of  possible  reasons  for  this  effect,  similar  to  the 
explanations for the area of human medicine and dentistry and for veterinary medicine (fig. 
5.1). 

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Figure 6.1:  Comparison of percentages of animals used for 
regulatory requirements for toxicological or other safety evaluation in 
1999 and 2002

0.00

10.00

20.00

30.00

40.00

50.00

60.00

6.2     National
legislation specific to a
single EC Member
State

6.37

10.51

6.3     EC legislation
(including European
Pharmacopoeia
requirements)

16.40

19.34

6.4     Member Country
of Council of Europe
(but not EC) legislation

2.36

0.34

6.5    Other legislation

6.14

3.58

1999

2002

6.6      Any combination
of 6.2/ 6.3/ 6.4 /6.5

53.67

55.52

 6.7       No regulatory
requirements

15.05

10.71

III.8.  Results  of  EU  Table  7:  Animals  used  in  toxicity  test  for  toxicological  or  other 

safety evaluations 

Figure 7.1 shows the percentage of animals used per toxicity test (group) in 1999 and 2002. 

Comparison with 1999  

As  pointed  out  earlier,  the  number  of  animals  used  in  toxicological  and  other  safety 
evaluation represented 10 % of the total number of animals used for experimental purposes in 
the EU. 

The largest percentage of animals was due to acute and sub-acute toxicity tests, about 37 % in 
2002  and  in  1999.  With  the  addition  of  sub-chronic  and  chronic  toxicity,  the  percentage  of 
animals used in short and long term systemic toxicity testing accounted for 46 % and 52 %, 
respectively,  in  2002  and  1999.  About  20  %  of  the  animals  were  used  for  tests  on 
carcinogenicity, mutagenicity and toxicity to reproduction in both years. 

In comparison with the data of 1999, there is a certain decrease in the percentage of animals 
used for sub-chronic and chronic toxicity tests from about 14 % to 9 % and for reproductive 
and  developmental  toxicity  from  about  15  %  to  12  %,  and  an  increase  in  the  percentage  of 
animals used in detecting toxicity to aquatic vertebrates from 0.5 % to 4.5 %.  

An increase is also observed, from about 20 % to 24 %, in the percentage of animals used for 
“other”  toxicity  tests  than  those  listed  in  the  statistical  Table.  24  %  is  about  ¼  of  all  such 

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animals and thus a considerable proportion. Member States considered that this may be due to 
a  variety  of  tests  conducted  by  universities  or  institutions,  which  may  not  follow  specific 
guidelines and were therefore summed up by researchers under “other”. Member States also 
indicated  that  “other”  might  include  tests  linked  to  haemotoxicology,  toxicokinetics, 
pyrogenicity,  biocompatibility,  immunotoxicology,  enzyme  induction  and  allergic  reactions 
of animals. 

Figure 7.1
Comparison of the percentages of animals used in toxicity tests 
for toxicological or other safety evaluation in 1999 and 2002

0,00

10,00

20,00

30,00

40,00

50,00

Acute and sub-acute
toxicity (including limit
tests)

irritation/sensitization 

6,08

5,85

38,28

36,72

Sub- chronic and chronic
toxicity

13,75

9,38

Mutagenicity and
carcinogenicity

6,10

7,31

 Reproductive and develop.
toxicity

15,42

12,10

Toxicity to aquatic
vertebrates not included in
other columns

0,54

4,53

  Other

19,54

24,11

1999

2002

III.9.  Results  of  EU  Table  8:  Type  of  toxicity  tests  carried  out  for  toxicological  or 

other safety evaluations of products 

As pointed out earlier, animals used in toxicological and other safety evaluation represent 10 
% of the total number of animals used for experimental purposes in the EU. 

A  substantial  number  of  toxicity  tests  were  performed  for  products  or  devices  for  human 
medicine,  dentistry  and  veterinary  medicine.  Other  notable  groups  of  products  requiring 
toxicological testing were products used mainly in agriculture and products intended mainly 
for industry. 

Remark: In 1999 the data provided by the Member States for EU Table 8 showed too much 
variability.  Therefore,  no  interpretation  of  the  data  was  possible,  and  consequently  no 
comparison is possible now. 

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