Commission staff working document - Annex to the: Report from the Commission to the Council and the European Parliament - Fifth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union - Part I {COM (2007) 675 final}
Date: 2007-11-05
Institutions: European Commission
Subjects: EU statistics, animal experimentation, animal welfare, impact study, report, scientific research

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.11.2007 
SEC(2007) 1455 

PART I 

COMMISSION STAFF WORKING DOCUMENT 

Annex to the:  

REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT  

Fifth Report on the Statistics on the Number of Animals used for Experimental and 
other Scientific Purposes in the Member States of the European Union 

{COM (2007) 675 final}

EN 

   EN 

 
 
 
 
 
 
 
TABLE OF CONTENTS 

I. 

II. 

INTRODUCTION ....................................................................................................... 3 

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

II.1. 

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

II.2. 

General assessment ...................................................................................................... 4 

II.3. 

Structure of the Report ................................................................................................. 6 

PART A: COMPILATION AND OVERVIEW OF THE DATA OF 2005 .............................. 7 

III.1.  Results of EU Table 1: Species and number of animals .............................................. 7 

III.2.  Results of EU Table 1: Origin of animals used ......................................................... 21 

III.3.  Results of EU Table 2: Purposes of the experiments................................................. 25 

III.4.  Results of EU Table 3: Toxicological and safety evaluation by type of 

product/endpoints....................................................................................................... 31 

III.5.  Results of EU Table 4: Animals used for studies of diseases .................................... 35 

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

products for human medicine and dentistry and for veterinary medicine ................. 41 

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

used in toxicological and other safety evaluations .................................................... 44 

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

safety evaluations....................................................................................................... 48 

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

other safety evaluations of products .......................................................................... 54 

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I. 

INTRODUCTION 

The  objective  of  this  report  is  to  present  to  the  Council  and  the  European  Parliament,  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, 
the  statistical  data  on  the  number  of  animals  used  for  experimental  and  other  scientific 
purposes in the Member States of the EU. 

The  first  two  statistical  reports  published  in  19942  and  19993  covering  data  on 
experimental animals collected in 1991 and 1996 respectively provided a limited amount 
of statistical analysis due to the absence of a consistent system of reporting the data on the 
use  of  experimental  animals  in  the  Member  States.  In  1997  an  agreement  was  reached 
between  the  competent  authorities  of  the  Member  States  and  the  Commission  to  submit 
data  for  the  future  reports  under  a  format  of  eight  harmonized  tables.  The  third  and  the 
fourth statistical reports published in 20034 and 20055 covering data collected in 1999 and 
2002  were  based  on  these  agreed  harmonized  tables.  This  allowed  a  much  wider 
interpretation of the results on the use of experimental animals in the EU. In spite of the 
progress made in the content of these two last statistical reports, it ought to be stressed that 
there were some inconsistencies in the data submitted by the Member States and also that 
in all cases except the report of 2003, one Member State collected data from another year.  

This Fifth Statistical Report covers for the first time data collected by 25 Member States as 
a result of the accession of 10 new Member States in 2005. It gives an overview of the year 
2005 with the exception of one Member State who reported data of 2004.  

The Commission Staff Working Document accompanies the “Report from the Commission 
to the Council and the European Parliament – Fifth Report on the Number of Animals used 
for  Experimental  and  other  Scientific  Purposes  in  the  Member  States  of  the  European 
Union”. The report summarizes the data and conclusions presented in this Staff Working 
Document. 

1 
2 
3 
4 
5 

OJ L 358, 18.12.1986, p.1. 
COM (94) 195 final 
COM (1999) 191 final 
COM (2003) 19 final 
COM (2005) 7 final 

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II. 

DATA SUBMITTED AND GENERAL ASSESSMENT 

II.1. 

Data submitted by the Member States  

All 25 Member States submitted the data in the agreed EU format.  

Regarding the quality of data, in most cases, Member States have applied a quality control 
check  on  the  set  of  data  submitted  for  2005.  This  exercise  was  the  first  for  the  10  new 
Member States (EU 10), and in general the coherence of the data has greatly improved for 
the other Member States.  

The quality check of the data submitted by the Member States is essentially governed by 
four criteria based on certain relationship between the data in the different tables. 

–  The first of these relationships is the total number of animals used by species, column 
1.2 of EU Table 1, which is broken down into purposes of experiments in EU Table 2. 
Thus, the totals of the Tables 1 and 2 should be identical. 

–  The  second  relationship  concerns  column  2.6  of  EU  Table  2  “animals  used  for 
toxicological  and  other  safety  evaluation”  which  is  broken  down  into  types  of 
products/endpoints,  EU  Table  3,  into  Regulatory  requirements,  EU  Table  6,  and  into 
types of toxicological tests, EU Table 7. The total at the bottom of column 2.6 must be 
equal to the total at the bottom of table 3, 6 and 7.  

–  The  third  relationship  is  that  the  sum  of  column  2.4  and  2.5  of  EU  Table  2  must  be 

equal to the total of EU Table 5.  

–  In  the  fourth  relationship,  the  total  row  of  EU  table  3  “animals  used  for  toxicological 
and other safety evaluation by types of products” should be equal to the total of table 8.  

For the present report it was generally considered that the quality criteria had sufficiently 
been respected to allow an analysis at European level of all eight EU tables.  

II.2.  General assessment 

Each  Member  State  is  requested,  pursuant  to  Articles  13  of  Directive  86/609/EEC,  to 
submit  to  the  Commission  the  statistical  data  on  the  animals  used  for  experimental  and 
other scientific purposes. The data covers the year 2005 with the exception of France who 
reported on the year 2004. Malta has reported no animal use in 2005. 

Council Resolution 86/C331/02 of the representatives of the Governments of the Member 
States  of  the  European  Communities,  meeting  within  the  Council  of  24  November  1986 
regarding  the  protection  of  animals  used  for  experimental  and  other  scientific  purposes6 
allows  the  use  of  animals  in  experiments  for  education  and  training,  but  where  the 
purposes  of  such  experiments  are  not  covered  by  the  Directive  i.e.  they  are  not 
experimental  or  scientific  in  the  sense  of  the  Directive,  Member  States  will  according  to 
the  Resolution  apply  national  provisions  which  are  no  less  severe  than  those  of  the 
Directive. Therefore, a number of Member States have also included animals covered by 
the Resolution in the report. 

6 

OJ C 331, 23.12.86, p. 2. 

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The first part of this report aims at providing a comprehensive overview on the numbers of 
animals used for  various  experimental purposes in the  Community in 2005. The  analysis 
will  look  at  the  purposes  of  the  use  of  animals.  Some  of  these  purposes  will  be  broken 
down  further  into  more  precise  parameters.  It  will  also  look  at  the  different  legislative 
requirements regarding the use of experimental animals and also the type of testing carried 
out on the different species of animals. For the first time the analysis will cover all eight 
tables submitted by the Member States in 2005.  

Because 10 new Member States are reporting data for the first time it will not be possible 
to draw conclusions on the evolution of the use  of  animals  for  experimental  purposed  in 
the EU by comparing data with those of the previous reports. However, some comparisons 
in trends will be attempted and significant changes in use will be highlighted in the report.  

The number of animals used in the 10 new Member States (EU 10) represents 8,6% of the 
total number of animals used in the 25 Member States (EU 25). Therefore, when any of the 
categories  reported  in  the  different  areas  show  a  significant  increase  or  decrease  beyond 
the 8,6%, this will be highlighted in the report  

In addition, in the first chapter of this report, Table 1bis with the data of EU 15 and Table 
1tris  with  the  data  of  EU  10  have  been  prepared  to  see  the  effects  of  the  new  Member 
States on the EU statistics. Furthermore, an attempt will be made to compare the results of 
the total number of animals used in 2005 within the “old” EU 15 with those submitted for 
the pervious reports. 

The  second  part  of  this  report  provides  the  individual  data  from  the  Member  States 
together with their respective comments and interpretations. 

In the EU, the total number of animals used for experimental and other scientific purposes 
in 2005 in the 25 Member States amounts to 12,1 million (with data from France of 2004).  

As  in  previous  reports  rodents  together  with  rabbits  represent  almost  78%  of  the  total 
number  of  animals  used  in  the  EU.  Mice  are  by  far  the  most  commonly  used  species 
covering 53% of the total use, followed by rats with 19%.  

The  second  most  used  group  of  animals  was,  as  in  previous  years,  cold-blooded  animals 
representing 15%. The third biggest group of animals was birds with a little over 5% of the 
total use. 

As in 2002, no Great Apes were used in experiments in the EU in 2005. 

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II.3. 

Structure of the Report 

The report is divided into two parts: 

A 

A global compilation and overview for the European Union of the statistical data 
of the Member States for 2005. 

A consolidated table has been computed on the basis of the data submitted by the 
Member States for each EU Table and is presented at the end of each chapter. 
Each table is illustrated by a graphical presentation to give a more readable 
overview of the EU situation. 

Similarly to what happened in 2002, the complete data for 2005 include statistics 
from the year 2004 in France. Therefore, the totals used in this report are a 
mixture of years. Comparisons were nevertheless made on this basis since no 
other data were available.  

The reader is invited to take note that the numbering of tables and graphical 
presentation in Part A of the report are linked to the numbers of the EU Tables 
and not to the numbering of the chapters of the report. 

B 

The data submitted by each Member State with a summary of the Member State’s 
comments. 

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PART A: COMPILATION AND OVERVIEW OF THE DATA OF 2005 

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

Two types of information can be drawn from the data submitted by the Member States in 
EU  Table  1.  The  first  is  relating  to  the  total  number  of  animals  used  subdivided  into  25 
species by the Member States. The second is relating to the place of origin of the animals 
used for experimental or other scientific purposes.  

III.1.1.  The data on the total number of animals used in the MS 

Table  1.1  of  this  report  presents  the  consolidated  data  on  the  number  of  animals  used  for 
experimental  purposes,  by  species,  submitted  by  25  Member  States.  Since  the  previous 
report  of  2002,  Table  1.1  includes  the  data  on the  number  of  animals  used  also  in  the  10 
new Member States.  

Malta  informed  the  Commission  that  no  animal  experiments  were  carried  out  in  their 
country in 2005. 

The  total  number  of  animals  used  in  2005  (France  reporting  for  2004)  in  the  25  Member 
States (EU 25) amounts to 12.1 million animals. It is important to note that the number of 
animals used in the 10 new Member States (EU 10) represents 8,6% of the total number of 
animals in the EU 25. This proportion will be used as the basis to highlight any changes in 
trends which significantly deviate from it.  

III.1.2.  Treatment and interpretation of the data of Table 1.1 

In  order  to  present  an  overall  evaluation  and  subsequently  a  graphical  analysis,  animals 
were grouped in classes. The result of this exercise is presented in Table 1.2 at the end of 
this chapter. Table 1.2 is illustrated by Figure 1.1. 

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Figure 1.1
Percentages of animals used by classes by the reporting 
Member States 

 Carnivores 0,33%

Prosimians+Monkeys+
Apes 0,09%

Artio+perissodactyla 
1,1%

 Birds 5,4%

Cold-blooded  animals 
15%

 Rabbits 2,6%

Other rodents 0,8%

Guinea-Pigs 2,1%

Rats 19%

Other mammals 0,08%

Mice 53%

Rodents together with rabbits represent 77,5% of the total number of animals used. Within 
the rodents class, mice (53%) and rats (19%) are by far the most used species. 

The second most used group is represented by cold-blooded animals with 15%. 

Birds is the next highest animal group being used for experimental purposes with 5,4% 

The  Artio  and  Perissodactyla  group 
including  horses,  donkeys  and  crossbreeds 
(Perrisodactyla), pigs, goats, sheep and cattle (Artiodactyla) represent only 1,1% of the total 
number of animals used in the Member States.  

Carnivores  represent  0,3%  of  the  total  number  of  animals  used  and  non-human  primates 
represent 0,1% of the animals used in 2005. 

III.1.3.  Comparison with the data of the previous reports  

In this chapter, and the following chapters dealing with comparisons, the reader is invited to 
take note of the fact that in 1996, in 2002 and 2005 one Member State (France) has reported 
data respectively for 1997, for 2001 and 2004. Nevertheless, assuming that fluctuations in 
the  annual  numbers  of  animals  used  per  species  in  a  country  are  limited,  it  is  possible  to 
make  semi-quantitative  estimates  of  the  observed  trends  by  comparing  changes  in 
proportions of use, expressed in percent. 

Comparison  between  proportions  of  classes  of  animals  used  in  1996,  1999 
2002 and 2005 

Class of species 
% Rodents-rabbits 
% 
animals 

Cold-blooded 

1996(*) 
81,3 
12,9 

1999 
86,9 
6,6 

2002(**) 
78,0 
15,4 

2005(***) 
77,5 
15, 

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% Birds 
% Artio Perissodactyla 

4,7 
1,2 

5 
1,2 

5,4 
1,1 

(*) 14 Member States reporting for 1996, one for 1997 

(**) 14 Member States reporting for 2002, one for 2001 

(***) 24 Member States reporting for 2005, one for 2004 

In overall, the percentages of rodents and rabbits show some fluctuation around 80%. For 
cold-blooded animals the proportion used in 1996, in 2002 and 2005 is between 10 to 15% 
but a much lower use of 6,6% was observed in 1999.  

Birds representing the third largest percentage of animal used, varies between 4 to 5%. The 
group of artio and perissodactyla fluctuates around 1%. 

The inclusion of the data of the new Member States (EU 10) should in principle increase the 
actual  numbers  of  animals  of  each  species  with  the  magnitude  of  around  8,6%.  However, 
the  use  of  some  species  has  decreased  compared  to  the  2002  report.  This  is  illustrated  in 
Table 1.0 below. 

Three other columns were included in Table 1.0 to show the change between 2002 and 2005 
among EU 15, and to further analyse the changes in total numbers. More substantial overall 
changes have been highlighted and in particular any changes among EU 15 contrary to the 
overall change. 

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%ch
ang
e 
sinc
e 
200
2 
in 
EU 
15 
10,6

-7,8

3,0

Table  1.0 :  Changes  in  species  number  and  proportion  between  2002  and 
2005 

Species 

Anima
l 
numb
ers 
in EU 
25 
2005 

Anima
l 
numb
ers 
in EU 
15 
2002 

Chan
ge 
since
2002 

%ch
an 
ge 
sinc
e.  
2002

Animal
numbe
rs 
in EU 
15 
2005 

Chang
e 
since 
2002 
in EU 
15 

64303
46 
23360
32 

54597
29
23113
44

25730
7 

22633
9
31535  52382

64474  58827

31268
1 
3898 

26767
5
3808
24119  21116

9706
17
2468
8

3096
8
-
2084
7
5647

4500
6
90
3003

60388
46 
21304
46 

23318
0 
30935 

17,8

1,1

13,7

-
39,8

9,6

47451 

16,8

2,4
14,2

29315
6 
3624 
22010 

57911
7 
-
18089
8 
6841 

-
21447 

-
40,9

-
11376 
25481 

-
19,3
9,5

-184 
894 

-4,8
4,2

2690 

2078

612

29,4

2512 

434  20,1

1.a  Mice (Mus musculus) 

1.b  Rats (Rattus 
norvegicus) 

1.c  Guinea-Pigs (Cavia 
porcellus) 
1.d  Hamsters 
(Mesocricetus ) 

1.e  Other Rodents (other 
Rodentia) 
1.f  Rabbits (Oryctolagus 
cuniculus) 
1.g  Cats (Felis catus) 
1.h  Dogs (Canis 
familiaris) 
1.i  Ferrets (Mustela 
putorius furo) 
1.j  Other Carnivores 

1.k  Horses, donkeys and 
cross breds (Equidae) 
1.l  Pigs (Sus) 
1.m Goats (Capra) 

8711 

3110

5601

5312 

4677

635

66305  61164
3016

2146 

5141
-870

1734 

-1376 

4310 

-367 

-
44,2
-7,8

180,
1
13,6

8,4
-
28,8
-3,1

56657 
1958 

26840 

-4139 

-4507 
-1058 

-7,4
-
35,1
-
13,4
-
18,3
-
38,2
372  31,2

-418 

1.n  Sheep (Ovis) 

30021  30979

-958

1.o  Cattle (Bos) 

36271  26569

9702

36,5

21694 

-4875 

1.p  Prosimians 
(Prosimia) 
1.q  New World Monkeys 
(Ceboidea) 
1.r  Old World Monkeys 
(Cercopithecoidea) 
1.s  Apes (Hominoidea) 

677 

1095

-418

1564 

1192

372

-
38,2
31,2

677 

1564 

8208 

8075

133

1,6

8151 

76 

0,9

0 

0

0

0

0 

0 

0

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1.t  Other Mammals 
(other Mammalia) 
1.u  Quail (Coturnix 
coturnix) 
1.v  Other birds (other 
Aves) 
1.w Reptiles (Reptilia) 

1.x  Amphibians 
(Amphibia) 
1.y  Fish (Pisces) 

1.z  TOTAL 

9950 

3618

6332

9246  12984 -3738

64981
3 
2477 

52198
3
3168

74620  59689

17491
78 
12117
583 

15864
03
10731
020

1278
30
-691

1493
1
1627
75
1386
563

175,
0
-
28,8
24,5

-
21,8
25,0

10,3

12,9

4701 

1083  29,9

7212 

-5772 

44528
1 
853 

-
76702 
-2315 

59402 

-287 

-
44,4
-
14,7
-
73,1
-0,5

16271
03 
11070
299 

40700 

2,6

33927
9 

3,2

The total number of hamsters, goats, prosimians, quail and reptiles have all decreased from 
40% to 22%. 

The biggest percentual change has, however, been noted in the increase of the use of other 
carnivores.  This  increase  is  essentially  due  to  the  addition  of  data  from  the  new  Member 
States (see Table 1.0) although these species are not used in great numbers (from 3110 to 
8711). This is further contrasted against a decrease in their use in EU 15. The other large 
increase both in EU 25 and also in EU 15 is for the use of other mammals (3618 to 9950).  

One  new  Member  State  reported  significant  use  of  'other  carnivores',  'other  mammals', 
cattle,  'other  rodents',  quails  and  horses,  pigs  and  other  birds,  in  comparison  with  other 
Member  States.  This  was  attributed  to  wildlife  and  environmental  research  studies  in  that 
specific geographical location, and testing in the areas of agricultural and animal breeding 
specific to that Member State. For further details see section B. 

Among  the  other  significant  increases  in  the  species  used  in  greater  numbers,  one  should 
mention the increase in the use of ferrets (29%), of cattle (36%), of other birds (25%) and of 
amphibians (25%). These increases, apart from ferrets, are all to be attributed to some of the 
new Member States. 

The use of non-human primates remained as in previous reports at around 0,1% of the total 
number of animals used. However, by looking at the species, the number of prosimians used 
decreased by 38% while new world monkeys increased by 31%. 

Member  States  reported  that  these  changes  may  be  attributed  to  changes  in  regulatory 
requirements for pharmaceuticals and in toxicological safety testing.  

As in 2002, no great apes were used for experimental or other scientific purposes in 2005. 

III.1.4.  Comparison with the data of the previous reports for the EU 15 

Since the total number of animals includes the data from the 10 new Member States it is not 
possible to draw a comparison per se with the results of the previous reports. However, to 
allow for some comparisons of trends of the animal use, separate Table 1 bis and 1 tris were 
drawn.  Table  1  bis  contains  the  data  of  EU  15  and  Table  1  tris  the  data  of  EU  10 
respectively. 

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In EU 15, the total number of animals used increased in 2005 by 339,279 which represents 
an increase of 3,1% with regard to 2002. 

By examining the data by species, the major increase observed in 2005 is the additional use 
of about 579,000 mice (10,6%). However this increase of mice is partly compensated by a 
decrease of the number of rats, hamsters and other rodents used (36%). In 2005 there is also 
an increase of the number of rabbits used for experimental purposes (9,5%). 

Among the other classes of animals, the use of ferrets for carnivores (20,8%) and the use of 
other  mammals  (30%)  has  increased.  The  changes  in  the  use  of  non-human  primates  as 
explained  in  chapter  III.1.3  are  mostly  results  of  changes  in  EU  15  as  only  57  old  world 
monkeys were used in EU 10 in 2005. 

On the other hand, the use of all species, within the class of artio and perissodactyla have 
decreased in comparison to 2002. The same is observed with birds. Finally, one can observe 
a substantial decrease of 73% in the use of reptiles. 

Further  breaking  down  the  category  'other',  Member  States  reported  use  of  the  following 
species: 

Other  rodents:  gerbils,  old  world  jerboas  (Jaculus  jaculus);  chinchilla,  beaver,  ground 
squirrel, hamsters, aremenio (Cricetulus migratorius) and different species of mice; 

Other  carnivores:  wild-life  species  used  for  zoological  and  ecological  studies  (e.g.  foxes, 
badgers, seals), otters, fitchew; 

Other mammals: boars, bats and shrews, llama, mole, European bison and red deer; 

Other  birds:  mainly  coturnix  japonica  and  bob-white  quail,  poultry  species,  and  zebra 
finches,  canary,  parakeet,  parrot  and  farmed  avian  species  for  example,  (Gallus  gallus 
domesticus) 

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Table 1.1: Total number of animals used for experimental purposes in the EU Member States 

Data of 2005 (*) 

AT 

BE  CY  CZ 

EE 
128634 488125  967  82252 1084358 208375 15340 393217 4350  1510334 138312 17776 534614 10480 5116  3280  0  240048 
6024 125754 484  424387 109479 7722 279774 2376 493  720  0  116608 
11920 106483 
7479 
3149 39530 

0  31703 435417 85664
5046
0 

LT  LU  MT  NL 

574 16780

0  100  0 

4 11533

37761

79350

4075

8360

HU 

DK 

297

DE 

ES 

FR 

EL 

LV 

IE 

IT 

0 

220
5798

7916
7622

5567 103329
1023
4868
560
235

29
264
159
7

402
6381

5805
16
566
19
242

0
40

908
294

0 
0 

8691
12683

1255 11878
168
685
237
0

0
14
0
0

66 
0 
0 
0 
0 

93282
1313
5539
155
0

137
381

9152
124
1206
0
0

0
0

379
119
167
0
0

1537
2303

9916
30
1064
0
0

0
0

0 
0 

0  0 
0  0 

5322 
3089 

166 158 
0 
0 
0 
0 

0
0
0
0

20  0 
0  0 
0  0 
0  0 
0  0 

8251 
334 
1049 
256 
151 

314

755

62

1

42

0 

223

6

189

63

1392
56

13166
275

7697
199

448
0

4818
119

720
711
0

3517
2909
99

156
489
0

99
0
0

821
294
0

0 
0 

0 
0 
0 

6587
442

4992
1296
578

882
2

382
0

381

601
32 2109
0

0

2579
20

584
1174
0

0

0
0

0
0
0

0

0 

0  0 

1705 

0 
0 

0 
0 
0 

0  0 
0  0 

9853 
328 

0  0 
0  0 
0  0 

2667 
4410 
0 

0 

0  0 

50 

0

0 

0 

0

408

0

0

1

0 

433

0

0

17

Species 

1.a. Mice 
1.b. Rats  
1.c. Guinea-
Pigs 
1.d.Hamsters 
1.e. Other 
Rodents  
1.f.  Rabbits 
1.g. Cats  
1.h. Dogs 
1.i.  Ferrets 
1.j.  Other 
Carnivores  
1.k. Horses, 
donkeys and 
cross breds 
1.l.  Pigs 
1.m.

Goats 
1.n. Sheep 
1.o. Cattle  
1.p.

Prosimia

ns 
1.q. N W 
Monkeys  

117
107

1874 
2260 

18439 21159 
81 
1295 
154 
0 

12
85
0
0

71

108 

818
44

195
536
0

1876 
157 

445 
944 
0 

0 
0 

0 
0 
0 
0 
0 

0 

0 
0 

0 
0 
0 

EN 

13 

EN 

 
  
 
 
1.r.  O W 
Monkeys 
1.s  Apes 
1.t.  Other 
Mammals  
1.u. Quail 
1.v. Other 
birds 
1.w. Reptiles  
1.x.

Amphibia

ns 
1.y. Fish 
1.z. TOTAL 

56

449 

0
0

0 
59 

0 

0 
0 

51

1579

0

0
188

0
115

0
185

1

0
0

81

0
60

0 

0 
0 

2778

0
0

6

0
0

0

395

0
48

0
68

14

425 
1011 13266 

0 
30
0  126211

2457
39150

0
7784

0
21

1
8424

4023

0 
0
283
0  102240 17151 2024 31697

0

40
865

144 
6177 

0 
0 

1475
293

136
10432

54
840

0
975

10
419

0 
0 

0
15675

25
1709

0
0

378
4636

0

0
0

0
0

0
0

0 

0 
0 

0 
0 

0 
0 

0  0 

277 

0  0 
0  0 

0 
13 

0  0 
152 
0  0  111081 

0  0 
0  0 

7 
3231 

1199 33965 

0  0  14838 
167312 718976  967  330933 1822424 365940 926092 595597 4900  2325398 297209 37940 896966 13319 5767  4120  0  531199 

64337 35958 901300 30584

9581 6420 14584

0  69418

50397

0 

0 

0

(*) France reporting for 2004 

EN 

14 

EN 

 
  
 
Table 1.1 Bis: Total number of animals used for experimental purposes in the 15 EU Member States reporting before 2005 

Data of 2005 (*) 

Species 

1.a. Mice 
1.b. Rats  
1.c. Guinea-
Pigs 
1.d.

Hamster

s 
1.e. Other 
Rodents  
1.f.  Rabbits 
1.g. Cats  
1.h. Dogs 
1.i.  Ferrets 
1.j.  Other 
Carnivores  
1.k. Horses, 
donkeys and 
crossbreeds 
1.l.  Pigs 
1.m.

Goats 
1.n. Sheep 
1.o. Cattle  
1.p.

Prosimia

ns 
1.q. N W 

AT 

DE 

BE 

T
IE 
128634 488125  1084358 208375 15340 393217 1510334  17776 534614 3280 240048 28318 120636 213727  1052064  60
6024 125754 424387  7722 279774 720 116608 6793 28358 83321  411501  21
11920  106483  435417 85664
2
5046

3149  39530 

574 16780

11533 100

79350 

28918 

37761

2014 

7479

DK 

UK 

379

563

SE 

ES 

NL 

FR 

LU 

PT 

EL 

FI 

IT 

4

117 

1874 

7916

402

0

908

8691 

107 

2260 

7622

6381

40

294

12683 

0

0

18439  21159  103329
1023
4868
560
235

81 
1295 
154 
0 

12 
85 
0 
0 

5805
16
566
19
242

1255 11878
168
685
237
0

0
14
0
0

93282 
1313 
5539 
155 
0 

379
119
167
0
0

1537

2303

9916
30
1064
0
0

71 

108 

755

62

1

42

223 

189

63

818 
44 

195 
536 
0 

1876 
157 

13166
275

7697
199

448
0

4818
119

6587 
442 

382
0

445 
944 
0 

3517
2909
99

156
489
0

99
0
0

821
294
0

601
4992 
1296  2109
0

578 

2579
20

584
1174
0

0 

0 

408

0

0

1

433 

0

17

0

0

20
0
0
0
0

0

0
0

0
0
0

0

5322

129

126

167 

3746 

3089

0

3187

1269 

8216 

8251
334
1049
256
151

594
0
36
0
0

1214
0
103
80
5

2112 
220 
1166 
47 
163 

15523 
308 
5373 
1004 
938 

2

1705

8

125

650 

308 

9853
328

2667
4410
0

113
4

290
45
0

1471
73

2722 
23 

4127 
274 

445
455
0

256 
727 
0 

11772 
6306 
0 

50

0

0

12 

643 

EN 

15 

EN 

 
  
 
 
 
Monkeys  
1.r.  O W 
Monkeys 
1.s. Apes 
1.t.  Other 
Mammals  
1.u. Quail 
1.v. Other 
birds 
1.w. Reptiles  
1.x.

Amphibia

ns 
1.y. Fish 
1.z. TOTAL 

56 

449 

1579

0

0 
0 

0 
59 

0
115

0
185

14 

425 
1011  13266 

2457
39150

0
7784

40 
865 

144 
6177 

136
10432

54
840

1

0
0

0
21

0
975

83

0
60

2778 

0 
0 

0

0
48

395

0
68

0

0
0

277

0
13

0

0
1

0

63 

2472 

0
972

0 
639 

0 
2541 

1

0
8424 102240  2024

4023 

0
31697

0
152
0 111081

0
112

0
5773

0 

140 
7838  114860 

4

10
419

0 
15675 

0
0

378
4636

0
0

7
3231

0
51

0
20

0 
5496 

84 
10585 

1199  33965 

0 14838 4748 93220 183049  192504  16
167312 718976  1822424 365940 926092 595597 2325398  37940 896966 4120 531199 41621 256826 505681  1874207  110

64337 35958 901300 30584

50397  6420

14584

(*) France reporting for 2004 

EN 

16 

EN 

 
  
 
Table 1.1 Tris: Total number of animals used for experimental purposes in the 10 New EU Member States  

Reporting for 2005 

Species 

1.a. Mice (Mus musculus) 
1.b. Rats (Rattus 
norvegicus) 
1.c. Guinea-Pigs (Cavia 
porcellus) 
1.d. Hamsters 
(Mesocricetus ) 
1.e. Other Rodents (other 
Rode 
1.f.  Rabbits (Oryctolagus 
cuniculus) 
1.g. Cats (Felis catus) 
1.h. Dogs (Canis familiaris) 
1.i.  Ferrets (Mustela 
putorius furo) 
1.j.  Other Carnivores (other 
Carnivores) 
1.k. Horses, donkeys and 
crossbred 
1.l.  Pigs (Sus) 
1.m. 
1.n. Sheep (Ovis) 
1.o. Cattle (Bos) 
1.p. Prosimians (Prosimia) 
1.q. New World Monkeys 
(Ceboidea) 
1.r.  Old World Monkeys 

Goats (Capra) 

EN 

CY 
967
0

CZ 
82252
31703

EE 
LV 
HU 
4350 138312 10480
2376

484 109479

PO 

LT  MT 
5116 
493 

0 126492
51558
0

SI 
SK 
8556 14975
6761
2732

Totals 

391500
205586

0

0

0

0
0
0

0

0

0
0
0
0
0
0

0

4075

220

5798

0

0

0

8360

297

137

381

0

0

0 

0 

0 

5567

66

9152

166

158 

29
264
159

7

314

1392
56
720
711
0
0

51

0 
0 
0 

0 

0 

0 
0 
0 
0 
0 
0 

0 

0
0
0

0

0

0
0
0
0
0
0

0

124
1206
0

0

6

882
2
381
32
0
0

6

0
0
0

0

0

0
0
0
0
0
0

0

17 

0

0

0

0

0
0
0

0

0

0
0
0
0
0
0

0

10763

38

594

24127

243

10826

0

18

0

0

600

17023

3101

533

782

19525

121
618
19

6970

681

7358
130
2023
13834
0
0

0

0
15
0

0

1

16
0
57
0
0
0

0

0
6
0

0

0

0
0
0
0
0
0

0

274
2109
178

6977

1002

9648
188
3181
14577
0
0

57

EN 

 
  
(Cercopithecoidea) 
1.s. Apes (Hominoidea) 
1.t.  Other Mammals (other 
Mammalia) 
1.u. Quail (Coturnix 
coturnix) 
1.v. Other birds (other Aves) 
1.w. Reptiles (Reptilia) 
1.x. Amphibians (Amphibia) 
1.y. Fish (Pisces) 
1.z. TOTAL 

0
0

0

0
188

30

0
0

0

0
0

283

0
0

0

0 
0 

0 

0
0

0

0
5061

1470

0
0

0

0
0

0
5249

251

2034

0 126211
1475
0
293
0
69418
0
967 330933

0
0
0
0

0
17151
0
25
0
1709
0
9581
4900 297209 13319

0 
0 
0 
0 
5767 

61148
121
13216
43076

204532
22
0
1624
3
0
15218
0
0
0
122075
0
0 358829 11991 23369 1047284

0
0
0
0

EN 

18 

EN 

 
  
Table 1.2: Classes of animals used for experimental purposes in the EU Member States 

Data of 2005 (*) 

 Species 
Mice  
Rats 
Guinea-Pigs 
Golden hamsters + other 
rodents 
Rabbits 
Cold-blooded animals(1) 
birds (2) 
Artio+Perissodactyla (3) 
Carnivores (4) 
Prosimians+monk3115+eys+ 
apes 
Other Mammals 
Total 

Species% total  
Mice  
Rats 
Guinea-Pigs  
Golden hamsters + other 
rodents 
Rabbits 
Cold-blooded animals(1) 
birds (2) 
Artio+Perissodactyla (3) 
Carnivores (4) 
Prosimians+monkeys+ 
apes 

EN 

CY  CZ 

AT 
BE 
128634  488125 967
0
0
0

11920  106483
3149  39530
4134

224 

EL 

DE 

DK 

LT
82252 1084358 208375  15340 393217 4350 1510334 138312 17776 534614  10480  51
424387 109479 7722 279774  2376  4
484
31703 435417
4
0
37761
0
0
15538

6024 125754
574 16780
1202

85664 
5046 
6783 

11533 
3840 

79350
21374

4075
6018

8360
518

297 
0 

HU 

EE 

ES 

FR 

LV 

IE 

IT 

40

18439  21159
2104  40286
1025  13691
3530
1664 
1530
97 
449
56 

0
0
71186
0 126241
3193
0
459
0
51
0

5567 103329
74905
41607
20622
6686
2086

5805 

1255 11878
36852  902275 31013
8425
0
1090
84

7784 
8603 
843 
0 

21
548
14
1

0 

59

0

188

115

185 

0

60

66
0
0
0
0
0

0

93282
66072
106263
13540
7007
3789

9152

379
11315 6420
17434 2024
1303 3281
286
1330
0
6

9916 
19598 
31697 
4420 
1094 
412 

166 
0 
0 
0 
0 
0 

1

0

0

48

68 

0 

167312  718976 967 330933 1822424 365940  926094 595597 4900 2325398 297209 37940 896966  13319  57

CY 
BE 
AT 
76,88  67,89 100
7,12  14,81 0,00
5,50 0,00
1,88 
0,57 0,00
0,13 

11,02 
1,26 
0,61 
0,99 
0,06 
0,03 

2,94 0,00
5,60 0,00
1,90 0,00
0,49 0,00
0,21 0,00
0,06 0,00

CZ 
24,85
9,58
1,23
1,82

1,68
21,51
38,15
0,96
0,14
0,02

DE 
59,50
23,89
2,07
0,85

5,67
4,11
2,28
1,13
0,37
0,11

19 

DK 
56,94 
23,41 
1,38 
1,85 

1,59 
10,07 
2,13 
2,35 
0,23 
0,00 

EL 
1,66
0,65
0,06
0,00

0,14
97,43
0,00
0,06
0,00
0,00

EE 
ES 
66,02 88,78
21,11 9,88
2,82 0,00
0,20 0,00

1,99 1,35
5,21 0,00
1,41 0,00
1,02 0,00
0,18 0,00
0,01 0,00

FR 
64,95
18,25
3,41
0,92

4,01
2,84
4,57
0,58
0,30
0,16

IE 

HU 
46,54 46,85
36,84 20,35
0,01
0,00

2,81
0,17

LV 

L
IT 
59,60  78,68  88
31,19  17,84  8
2,23  0
0,00  0

1,29 
0,43 

3,08
1,00
3,81 16,92
5,33
5,87
8,65
0,44
0,75
0,45
0,00
0,00

1,11 
2,18 
3,53 
0,49 
0,12 
0,05 

1,25  2
0,00  0
0,00  0
0,00  0
0,00  0
0,00  0

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
0,01 0,00
100 100

0,00 
 Other Mammals  
Total 
100 
Malta has reported 0 animals used in 2005 
France reporting for 2004 
(*) 
(1) 
= Reptiles +amphibians + fish 
(2) 
= Quails and other birds 
(3) 
= Horses, donkeys and cross bred + pigs +goats and sheep + cattle 
(4) 
= cats + dogs + ferrets + other carnivores 

0,06
100

0,01
100

0,05 
100 

0,00
100

0,01 0,00
100
100

0,00
100

0,00
100

0,13
100

0,01 
100 

0,00  0
1
100 

EN 

20 

EN 

 
  
III.2.  Results of EU Table 1: Origin of animals used 

III.2.1.  The data on the origin of the species 

The  consolidated  results  of  EU  Table  1  on  the  origin  of  some  selected  species  used  for 
experimental purposes in the 25 Member States are reported in Table 1.3 at the end of this 
chapter.  The  consolidated  table  only  indicates  species  for  which  the  origin  must  be 
reported.  

In addition, EU Table 1 requires that Member States report the number of animals re-used 
in experiments. 

III.2.2.  Treatment and interpretation of the data 

The data of column 1.3 and 1.4 of Table 1.3 of this report have been grouped to represent 
animals coming from the Community. 

Figure 1.2 represents the percentage of origin of animals versus the species.  

Figure 1.2:  Origin of species 

100%

80%

60%

40%

20%

0%

e
c
M

i

s
t
a
R

Other countries

ETS 123 countries

EU countries

s
e
p
A

l
i

a
u
Q

s
y
e
k
n
o
M
d
l
r
o
W
w
e
N

s
y
e
k
n
o
M
d
l
r
o
W
d
O

l

s
r
e

t
s
m
a
H

s
t
i

b
b
a
R

s
t

a
C

s
g
o
D

s
t

e
r
r
e
F

i

s
n
a
m
s
o
r
P

i

i

s
g
P
-
a
e
n
u
G

i

The  chart  shows  that  the  majority  of  the  species  originated  from  the  EU  countries. 
However, certain species such as cats, dogs and ferrets and old world monkeys are of non-
European origin. 

III.2.3.  Comparison with data of the previous report 

The  general  pattern  on  the  origin  of  the  species  is  quite  similar  to  that  observed  in  the 
previous reports. It should be noted however, that for the first time in 2005 the prosimians 

EN 

21 

   EN

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
were all of EU origin. A similar trend can also be observed with the new world monkeys 
where an increasing amount was either of EU or ETS 123 origin at the expense of other 
countries. Also, old world monkeys coming from EU origins increased. On the other hand 
the  number  of  cats  not  of  European  origin  has  increased  in  comparison  to  the  report  of 
2002. 

EN 

22 

   EN

 
Table 1.3: Number of animals used in relation to their place of origin 

Data of 2005 

1.1.Species 

1.2. Total

1.3.Animals 
coming from 
registered 
breeding or 
supplying 
establishments 
within the reporting 
country 

1.4. 
Animals 
coming 
from 
elsewhere 
in the EC 

1.5.Animals coming 
from Member Countries 
of the Council of 
Europe which are 
parties to the 
Convention ETS 123 
(excluding EC Member 
States) 

1.6.Animals 
coming from 
other origins 

1.7.Re-used 
animals 

1.a. Mice (Mus musculus) 
1.b. Rats (Rattus norvegicus) 
1.c. Guinea-Pigs (Cavia 
porcellus) 
1.d. Hamsters (Mesocricetus ) 
1.f.  Rabbits (Oryctolagus 
cuniculus) 
1.g. Cats (Felis catus) 
1.h. Dogs (Canis familiaris) 
1.i.  Ferrets (Mustela putorius 
furo) 
1.p. Prosimians (Prosimia) 
1.q. New World Monkeys 
(Ceboidea) 
1.r.  Old World Monkeys 
(Cercopithecoidea) 
1.s. Apes (Hominoidea) 

6430346
2336032
257307

31535
312681

3898
24119
2690

677
1564

8210

0

EN 

5408519
2002798
178363

842034 
294875 
69291 

38621
17328
3245

141172
21031
6408

25276
294616

2251
15542
1662

578
1244

1459

0

4448 
15595 

492 
2732 
240 

99 
195 

719 

0 

23 

641
839

34
220
50

0
65

38

0

1170
1631

1121
5625
738

0
60

5994

0

254 
118 
2 

0 
13488 

1007 
3763 
22 

111 
410 

1740 

0 

EN 

 
  
 
 
 
1.u. Quail (Coturnix coturnix) 
1.z. TOTAL 

9246
9418305

8860
7941168

0 
1230720 

152
61233

234
185184   

0 

Note 1 

Column  1.5  concerns  only  those  Member  countries  of  the  Council  of  Europe  which,  at  the 
beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of 
those countries has to be used when filling in this column 

(Note 2:  Only species for which origin has to be reported are included in this table) 
Note 3: 

The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2. 

EN 

24 

EN 

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

III.3.1.  The data on purpose of the experiments 

The  consolidated  data  on  purposes  of  the  experiments  of  the  25  Member  States  are  presented  in 
Table 2.1 at the end of this chapter. 

III.3.2.  Treatment and interpretation of the data  

Table 2.2 presents the results of the consolidated data of the purposes of the procedures carried out 
in the 25 Member States in 2005. In order to facilitate the presentation of results some species and 
some purposes were grouped. 

The percentage of the number of animals used for selected purposes is presented in Figure 2.1.  

Figure 2.1 
Purposes of experiments

Education and training 
1,6%

Other 8%

Diagnosis of disease 2%

Toxicological and other 
safety evaluation 8%

Production and quality 
control veterinary 
medicine 3.5%

Fundamental biology 
studies 33%

Production and quality 
control human medicine 
and dentistry  11,8%

Research and develop 
human +veterin+dentist 
31%

As in previous years, more than 60% of animals were used in research and development for human 
medicine, veterinary medicine, dentistry and in fundamental biology studies. 

Production and quality control of products and devices in human medicine, veterinary medicine and 
dentistry required the use of 15,3% of the total number of animals reported in 2005. 

Toxicological  and  other  safety  evaluation  represents  8%  of  the  total  number  of  animals  used  for 
experimental purposes.  

III.3.3.  Comparison with the data of the previous report  

It  must  be  remembered  that  the  comparison  is  aiming  to  detect  changes  in  trends  rather  than 
drawing  formal  conclusions.  The  most  significant  change  that  can  be  identified  is  the  number  of 
animals  used  for  toxicological  and  other  safety  evaluation,  which  has  dropped  from  about  9,9% 

EN 

25 

   EN 

 
 
(data of 2002) to 8% for the data submitted by 25 Member States for this report. The decrease is 
also important in total numbers, i.e. from 1,066,047 to 1,026,286 animals while at the same time 
covering the 10 new Member States. 

The percentage of animals used for education and training is also showing a decreasing trend while 
other  purposes  seem  to  indicate  an  increase.  In  terms  of  numbers  of  animals  the  decrease  ranges 
from 341,967 to 198,994 and the increase from 597,960 to 984,238 respectively.  

The  decrease  of  animals  used  for  education  and  training  can  be  attributed  to  both  an  uptake  of 
alternative techniques and the re-use of animals. 

'Other' purposes covers amongst other things virology, immunology for production of monoclonal 
and  polyclonal  antibodies,  physiology  of  foetal-maternal  interaction  in  mouse  gene  transgensis, 
oncological treatment, pharmaceutical R&D, combined drug testing and genetics.  

Table 2.2: Number of animals used for selected purposes versus species 

Other

Total 

Diagn
osis of 
diseas
e 

Educati
on and 
training 

Toxicolo
gical and 
other 
safety 
evaluatio
ns 
(includin
g safety 
evaluatio
n of 
products
) 

Species 

Mice  

Rats  

Other rodents 
Rabbits 
Carnivores 
Artio+perissodactyla 

Biologic
al 
studies 
of a 
fundam
ental 
nature 

Resear
ch,deve
lopment 
and 
quality 
control 
of 
product
s and 
devices 
for 
human 
medicin
e and 
dentistr
y and 
for 
veterina
ry 
medicin
e) 
272725
4
677533  116151
7
53241  230403
15463  237411
9309
11605 
41079
64419 

246547
4 

384741

350275

22552
4
13564

56006
38761
14884
4542

4512
8322
348
4100

16

0

86597  5513
56
50048  7287
6
2606  6548
3856  8829
674  2339
9491  1634
1
536

42 

6440946

2325813

353316
312642
39159
139972

10451

4 

739

9950

Prosimians+monkeys+
apes 
Other mammals  

1456 

1397

7004

8978 

214

15

EN 

26 

   EN 

 
 
 
Birds 

251443  249024

53935

9723

Cold-blooded animals 

485858  942973

116123

5905

TOTAL 

403547
0 

560058
1

1026286

27201
4

5440  8949
4
40236  2351
80
198994  9842
38

659059

1826275

1211758
3

Figure 2.2 presents the number of animals used for selected purposes by classes of species.  

From  Figure  2.2  one  can  see  that  the  highest  amount  of  use  of  mice  and  rats  is  attributed  to 
fundamental  biology  and  also  of  research,  development  and  control  of  products  and  devices  for 
medicine, dentistry and veterinary medicine. The use of cold-blooded animals is following a similar 
pattern for different purposes. 

EN 

27 

   EN 

 
Figure 2.2
Species and experimental purposes

Other

 Education and training

Diagnosis of disease

 Toxicological and other safety evaluations (including safety
evaluation of products)                   

Research,development and quality control of products and
devices for  human medicine and dentistry and for veterinary
medicine)

   Biological studies of a fundamental nature

s
d
r
i

B

l

s
a
m
m
a
M

r
e
h
t
O

i

s
r
o
v
n
r
a
C

l

a
y
t
c
a
d
o
s
s
i
r
e
p
+
o
i
t
r

A

l

)
s
u
u
c
n
u
c

i

l

s
u
g
a
o
t
c
y
r
O

(

s
t
i
b
b
a
R

s
e
p
a
+
s
y
e
k
n
o
m
+
s
n
a
m
s
o
r
P

i

i

i

l

s
a
m
n
a
d
e
d
o
o
b
-
d
o
C

l

l

3000000

2500000

2000000

1500000

1000000

500000

0

l

)
s
u
u
c
s
u
m
s
u
M

(
e
c
M

i

s
t
n
e
d
o
r

r
e
h
t
O

i

)
s
u
c
g
e
v
r
o
n

s
u
t
t
a
R

(

s
t
a
R

EN 

28 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 2.1: Number of animals used in experiments for selected purposes  
Purposes versus species 
data of 2005* 

2.1Species 

2.2. 
Biologic
al 
studies 
of a 
fundam
ental 
nature 

1.a. Mice (Mus musculus) 

1.b. Rats (Rattus norvegicus) 

1.c. Guinea-Pigs (Cavia porcellus) 
1.d. Hamsters (Mesocricetus ) 
1.e. Other Rodents (other 
Rodentia) 
1.f.  Rabbits (Oryctolagus 
cuniculus) 
1.g. Cats (Felis catus) 
1.h. Dogs (Canis familiaris) 
1.i.  Ferrets (Mustela putorius furo) 
1.j.  Other Carnivores (other 

246547
4
677533

12911
10716
29614

15463

1123
1997
510
7975

EN 

2.3. Research 
and 
development 
of products 
and devices 
for human 
medicine and 
dentistry and 
for veterinary 
medicine 
(excluding 
toxicological 
and other 
safety 
evaluations 
counted in 
column 2.6) 
1639698

2.5.Producti
on and 
quality 
control of 
products 
and devices 
for 
veterinary 
medicine 

2.4.Produc
tion and 
quality 
control of 
products 
and 
devices for 
human 
medicine 
and 
dentistry 

2.6.Toxicolo
gical and 
other safety 
evaluations 
(including 
safety 
evaluation 
of products 
and devices 
for human 
medicine 
and 
dentistry 
and for 
veterinary 
medicine 

902318

185238

384741

920875

209791

30851

350275

2.9.Oth
er 

2.10.To
tal 

2.7.Dia
gnosis 
of 
diseas
e 

2.8.Educ
ation 
and 
training 

22552
4
13564

2150
1395
967

86597

50048

1691
390
525

551356  644094
6 
72876  232581
3 
3739  257307 
31535 
64474 

825 
1984 

53498
1670
838

47490
6167
30359

111505
274
0

32814

185572

1044
4457
1299
0

138
244
42
0

29 

24323
10098
187

19025

687
1182
14
202

38761

8322

3856

8829  312642 

222
14621
41
0

64
243
41
0

129
500
45
0

491 
616 
698 
534 

3898 
23860 
2690 
8711 

EN 

 
  
Goats (Capra) 

Carnivore) 
1.k. Horses, donkeys and cross 
breds (Equidae) 
1.l.  Pigs (Sus) 
1.m. 
1.n. Sheep (Ovis) 
1.o. Cattle (Bos) 
1.p. Prosimians (Prosimia) 
1.q. New World Monkeys 
(Ceboidea) 
1.r.  Old World Monkeys 
(Cercopithecoidea) 
1.s. Apes (Hominoidea) 
1.t.  Other Mammals (other 
Mammalia) 
1.u. Quail (Coturnix coturnix) 
1.v. Other birds (other Aves) 
1.w. Reptiles (Reptilia) 
1.x. Amphibians (Amphibia) 
1.y. Fish (Pisces) 

1.z. TOTAL 

(*)France reporting for 2004 

1293

27052
828
10442
24804
384
357

715

0
8978

1722
249721
1646
55349
428863

403547
0

1957

6610
41
1217
2369
0
0

0

0
70

472

15159
280
2721
3691
0
327

654

0
144

0
104833
13
253
933278

203

489
84
5731
55
0
43

373

0
0

0
12727
0
0
280

0
131464
0
0
9149

3191
50744
12
542
115569

3746028

1429869

424684

1026286

40

182

973

192 

5312 

3349
39
457
657
97
650

6257

0
15

1888
214
871
945
0
16

0

0
0

0
9723
0
99
5806

27201
4

5854
317
956
1391
0
5

37

0
4

169
5271
774
15666
23796

198994

5821 
343 
7626 
2359 
196 
166 

66222 
2146 
30021 
36271 
677 
1564 

174 

8210 

0 
739 

0 
9950 

3913 

32 
2711 

8995 
85581  650064 
2477 
74620 
232437  174917
8 
984238  121175
83 

EN 

30 

EN 

 
  
III.4.  Results  of  EU  Table  3:  Toxicological  and  safety  evaluation  by  type  of 

product/endpoints 

III.4.1.  The data on toxicological and safety evaluation by type of products/endpoints 

The consolidated table giving the number of animals used in toxicological and other safety 
evaluation of products (EU Table 3) in 25 Member States is presented in Table 3.1 at the 
end of this chapter. 

The percentage of the number of animals used for different types of product is presented in 
Figure 3.1. 

III.4.2.  Treatment and interpretation of the data 

Figure 3.1
Animals used in toxicological and other safety experiments

3.9   Potential  or actual 
contaminents in the general 
environment which do not 
appear in other columns
8,3%

3.10    Other  toxicological or 
safety evaluations
17,6%

3.2    Products/ substances 
or devices for human 
medicine and dentistry and 
for veterinary medicine
50,9%

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

3.7    Products/ substances 
used or intended to be used 
mainly as additives in food 
for human consumption
0,4%

3.6    Products/ substances 
used or intended to be used 
mainly as cosmetics or  
toiletries
0,5%

3.5   Products/ substances 
used or intended to be used 
mainly in the household
0,1%

3.4   Products/ substances 
used or intended to be used 
mainly in industry
9,4%

3.3     Products/ substances 
used or intended to be used 
mainly in agriculture
9,5%

In  table  3.1  the  number  of  animals  used  for  toxicological  or  other  safety  evaluation  is 
broken down into type of products for which testing was required. 

Only  8%  of  the  total  number  of  animals  used  for  experimental  purposes  is  used  for 
toxicological and other safety evaluation. This accounts for 1,026,286 animals (see III.3.3)  

toxicological  evaluation  of  4  groups  of 
The  percentage  of  animals  used  for 
products/substances,  i.e.,  animal  feed,  additives  for  human  food  consumption,  cosmetics 
and household, is very small (4,3%) when compared to the other products groups. 

Products or devices used for human medicine, veterinary medicine and dentistry represents 
50,9% of the animal used for toxicological or other safety evaluations. 

EN 

31 

   EN

 
 
The group of products/substances falling under the scrutiny of authorities concerned with 
safety of health and of the environment by chemical products, such as industrial chemicals 
and pesticides, used 19% of the animals for toxicological and other safety evaluations.  

There  is  a  strong  decrease  in  the  number  of  animals  used  for  toxicological  tests  for 
products intended for industry, for agriculture, products for potential contaminants of the 
environment  (decrease  ranging  from  above  123,000  to  below  98,000)  and  also  tests  for 
products for household and for additives in food for human consumption, categories using 
lower numbers, in comparison to the data submitted in the last statistical report.  

There is a noticeable increase (50%) in the number of animals used for testing cosmetics 
or toiletries, however, the actual numbers of animals in this category remain low (5,571 in 
total). This increase, attributed mainly to one old Member State, is worth noting in light of 
the legal requirement to phase out animal testing for cosmetics in the EU. There is also a 
significant increase in the number of animals used for tests for additives in food for animal 
consumption (3,447 to 34,225 - 10 fold).  

It should also be noted that in comparison to the 2002 report there is a significant increase 
in the number of animals used for other toxicological  or  safety  evaluation (ranging from 
around  110,000  to  180,000).  This  category  could  benefit  from  further  analysis.  Member 
States reported that it concerned new methods and tests, such as: tests on transmission of 
microcystins  on  embryonic  membrane;  bioassays;  toxicity  evaluation  for  humans  via  the 
environment; and control of safety for toys. 

EN 

32 

   EN

 
3.1.Species 

Table 3.1: Number of animals used in toxicological and other safety evaluation 
Products versus species 

3.2. 
Products/ 
substances 
or devices 
for human 
medicine 
and dentistry 
and for 
veterinary 
medicine 

Data of 2005* 

3.4.Prod
ucts/ 
substan
ces 
used or 
intended 
to be 
used 
mainly 
in 
industry 

3.5.Prod
ucts/ 
substan
ces 
used or 
intended 
to be 
used 
mainly 
in the 
househo
ld 

3.6.Prod
ucts/ 
substan
ces 
used or 
intended 
to be 
used 
mainly 
as 
cosmeti
cs or 
toiletries

3.3. 
Produc
ts/ 
substa
nces 
used or 
intende
d to be 
used 
mainly 
in 
agricult
ure 

3.9.Poten
tialor 
actual 
contamin
ants in 
the 
general 
environm
ent which 
do not 
appear in 
other 
columns 

3.7.Prod
ucts/ 
substan
ces 
used or 
intended 
to be 
used 
mainly 
as 
additive
s in food 
for 
human 
consum
ption 

3.8.Prod
ucts/ 
substan
ces 
used or 
intended 
to be 
used 
mainly 
as 
additive
s in food 
for 
animal 
consum
ption 

1.a. Mice (Mus musculus) 

210 840

18 546

26 677

72

1 797

1 268

1 630

9 264

1.b. Rats (Rattus norvegicus) 

210 719

41 903

44 768

2 226

2 644

704

8 883

1.c. Guinea-Pigs (Cavia 
porcellus) 
1.d. Hamsters (Mesocricetus 
) 
1.e. Other Rodents (other 
Rodentia) 
1.f.  Rabbits (Oryctolagus 
cuniculus) 
1.g. Cats (Felis catus) 
1.h. Dogs (Canis familiaris) 
1.i.  Ferrets (Mustela putorius 
furo) 

294

177

0

0

35 123

3 051

7 128

1 065

571

300

68

18

28

940

0

0

46

0

0

0

0

0

26 030

3 593

4 433

116

608

141

113

222
12 671
41

0
509
0

0
278
0

0
0
0

0
0
0

0
0
0

0
0
0

156

0

442

25

0
29
0

3.11.To
tal 

3.10.Other 
toxicological 
or safety 
evaluations 

116 850 

36 707 

386 
944 
348 
648 
6 877  53 498 

16 

1 670 

0 

838 

4 094  39 153 

0 

222 
1 118  14 605 
41 

0 

EN 

33 

EN 

 
  
Goats (Capra) 

1.j.  Other Carnivores (other 
Carnivore) 
1.k. Horses, donkeys and 
cross breds (Equidae) 
1.l.  Pigs (Sus) 
1.m. 
1.n. Sheep (Ovis) 
1.o. Cattle (Bos) 
1.p. Prosimians (Prosimia) 
1.q. New World Monkeys 
(Ceboidea) 
1.r.  Old World Monkeys 
(Cercopithecoidea) 
1.s. Apes (Hominoidea) 
1.t.  Other Mammals (other 
Mammalia) 
1.u. Quail (Coturnix coturnix) 
1.v. Other birds (other Aves) 
1.w. Reptiles (Reptilia) 
1.x. Amphibians (Amphibia) 
1.y. Fish (Pisces) 

0

35

2 246
24
351
489
97
613

5 057

0
15

0
9 246
0
0
6 937

0

5

90
5
10
48
0
0

0

0
0

0

0

47
0
0
0
0
0

6

0
0

0

0

0
0
0
0
0
0

0

0
0

3 161
3 728
0
400
21 944

0
98
0
0
12 998

0
0
0
0
560

0

0

0
0
0
0
0
0

0

0
0

0
0
0
0
0

0

0

76
0
0
0
0
0

0

0
0

0
0
0
0
0

0

0

444
0
10
105
0
0

0

0
0

0

0

103
10
72
0
0
0

0

0
0

0
31 119
0
100
0

25
1 437
0
0
64 286

1.z. TOTAL 

522 121

97 632

96 479

1 219

5 571

4 175

34 225

84 732

(*) France reporting for 2004 

0 

0 

241 
0 
14 
15 
0 
37 

0 

40 

3 247 
39 
457 
657 
97 
650 

1 194 

6 257 

0 
0 

0 
15 

0 

12 
42 
7 799 

3 186 
5 116  50 744 
12 
542 
114 
524 
1 026 
286 

180 132 

EN 

34 

EN 

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

III.5.1.  The data on animals used for studies of diseases 

The consolidated table of results on animals used for studies of diseases (EU Table 4) in 
the 25 Member States is presented in Table 4.1 at the end of this chapter. 

III.5.2.  Treatment and interpretation of the data 

Table 4.1 gives the number of animals used per type of studies on diseases. In 2005, the 
number of animals used for the study of both animal and human diseases represented more 
than half (57,5%) the total number of animals used for experimental purposes in the EU. 

Figure 4.1 presents the percentage of animals used in studies per type of diseases.  

The  percentage  of  the  number  of  animals  used  for  studies  of  human  diseases  represents 
81% of the total number of animals used for all studies of diseases. 

Figure 4.1
Proportion of animals used for the study of diseases

Human 
Cardiovascular 
diseases
6%

Specific animal 
diseases
19%

Other human 
diseases
40,5%

Human nervous and 
mental disorder
21,6%

Human cancer (excl. 
evaluation of carcino 
hazards)
12,8%

In  2005,  the  proportion  and  the  number  of  animals  used  (ranging  from  900,000  to 
1,329,000) for the studies of animal diseases have increased significantly when compared 
with the report of 2002. 

It should be remembered that the studies on specific animal diseases are important in the 
light  of  epidemics  of  farm  animals  such  as  in  the  case  of  cows,  foot  and  mouth  disease, 
swine  fever  and  more  recently  avian  flew.  Animals  used  also  covers  studies  on  genetic 
diseases.  

An  important  part,  around  60%,  of  the  increase  of  the  total  use  of  mice  (579,000)  in 
comparison with 2002, can be attributed to different studies of diseases. 

EN 

35 

   EN 

 
 
Table 4.1: Number of animals used in experiments for studies on human and animal diseases  

Main category of diseases versus species 
Data of 2005 * 

4.1 Species 

4.2 Human 
cardiovascular 
diseases 

4.3 Human 
nervous 
and mental 
disorders 

1.a. Mice (Mus musculus) 
1.b. Rats (Rattus norvegicus) 
1.c. Guinea-Pigs (Cavia 
porcellus) 
1.d. Hamsters (Mesocricetus ) 
1.e. Other Rodents (other 
Rodentia) 
1.f.  Rabbits (Oryctolagus 
cuniculus) 
1.g. Cats (Felis catus) 
1.h. Dogs (Canis familiaris) 
1.i.  Ferrets (Mustela putorius 
furo) 
1.j.  Other Carnivores (other 
Carnivore) 
1.k. Horses, donkeys and cross 
breds (Equidae) 
1.l.  Pigs (Sus) 
1.m. 
1.n. Sheep (Ovis) 

Goats (Capra) 

233054
154838
4721

2121
84

843362
610191
7581

4471
24311

11601

3769

13
1538
228

2

8

4902
184
759

203
367
159

0

29

943
25
523

4.5 Other 
human 
diseases 

4.6 Studies 
specific to 
animal 
diseases 

4.7 Total 

4.4 Human 
cancer 
(excluding 
evaluations of 
carcinogenic 
hazards or 
risks) 

801787
80825
781

1862317
642300
57019

158718
5251
5200

3899238
1493405
75302

579
487

631

52
347
33

0

8

198
3
52

7302
12750

23941

339
6001
1693

500

110

8548
481
7138

2931
3038

7864

992
2395
71

540

919

11226
205
7953

17404
40670

47806

1599
10648
2184

1042

1074

25817
898
16425

EN 

36 

EN 

 
  
 
1.o. Cattle (Bos) 
1.p. Prosimians (Prosimia) 
1.q. New World Monkeys 
(Ceboidea) 
1.r.  Old World Monkeys 
(Cercopithecoidea) 
1.s. Apes (Hominoidea) 
1.t.  Other Mammals (other 
Mammalia) 
1.u. Quail (Coturnix coturnix) 
1.v. Other birds (other Aves) 
1.w. Reptiles (Reptilia) 
1.x. Amphibians (Amphibia) 
1.y. Fish (Pisces) 
1.z. TOTAL 

France reporting for 2004 

140
0
58

53

0
250

1841
383
204

167

0
189

0
1443
13
1067
300
417377

197
6282
115
1338
3898
1510548

0
0
2

179

0
3

0
0
0
2923
421
889311

2608
0
810

2882

0
1777

25
27269
24
10297
146936
2823067

7727
0
0

9

0
65

12316
383
1074

3290

0
2284

0
159253
79
277
954534
1329247

222
194247
231
15902
1106089
6969550

EN 

37 

EN 

 
  
Table 4.2: Number of animals used in studies of diseases by classes of animals 

Classes of animals 

Human 
Cardiovascular 
diseases 

Human 
nervous 
and mental 
disorder 

Human 
cancer (excl. 
evaluation of 
carcino 
hazards) 

Other human 
diseases 

Specific 
animal 
diseases 

Total  

Mice  
Rats  
Guinea-Pigs  
Other rodents 
Rabbits  
Carnivores 
Artio + Perrisodactyla 
Prosimians+Monkeys+Apes 
Other Mammals  
Birds 
Cold-blooded animals 
TOTAL 

Classes of animals% 

Mice  
Rats  
Guinea-Pigs  
Other rodents 
Rabbits  

EN 

233054
154838
4721
2205
11601
1781
5993
111
250
1443
1380
417377

843362
610191
7581
28782
3769
729
3361
754
189
6479
5351
1510548

801787
80825
781
1066
631
432
261
181
3
0
3344
889311

1862317
642300
57019
20052
23941
8533
18885
3692
1777
27294
157257
2823067

158718
5251
5200
5969
7864
3998
28030
9
65
159253
954890
1329247

Human 
Cardiovascular 
diseases 

Human 
nervous 
and mental 
disorder 

Human 
cancer (excl. 
evaluation of 
carcino 
hazards) 

Other human 
diseases 

Specific 
animal 
diseases 

3899238
1493405
75302
58074
47806
15473
56530
4747
2284
194469
1122222
6969550

Total  

5,98
10,37
6,27
3,80
24,27

21,63
40,86
10,07
49,56
7,88

20,56
5,41
1,04
1,84
1,32

47,76
43,01
75,72
34,53
50,08

4,07
0,35
6,91
10,28
16,45

100,00
100,00
100,00
100,00
100,00

38 

EN 

 
  
 
 
 
 
 
 
 
 
 
Carnivores 
Artio + Perrisodactyla 
Prosimians+Monkeys+Apes 
Other Mammals  
Birds 
Cold-blooded animals 
TOTAL 

11,51
10,60
2,34
10,95
0,74
0,12
5,99

4,71
5,95
15,88
8,27
3,33
0,48
21,67

2,79
0,46
3,81
0,13
0,00
0,30
12,76

55,15
33,41
77,78
77,80
14,04
14,01
40,51

25,84
49,58
0,19
2,85
81,89
85,09
19,07

100,00
100,00
100,00
100,00
100,00
100,00
100,00

EN 

39 

EN 

 
  
Species  of  Table  4.1  were  grouped  into  classes  of  animals  to  present  Table  4.2.  The 
relative percentage of animals per classes of species used in studies by type of diseases has 
been calculated and is also presented in the lower part of Table 4.2. 

Figure  4.2  presents  the  proportion  of  animals  used  by  classes  per  type  of  studies  of 
diseases.  

Figure 4.2
Proportion of animals used by classes per type of studies of 
diseases

100%

80%

60%

40%

20%

0%

e
c
M

i

s
t
a
R

Specific animals diseases  %

Other human diseases %

Human cancer (excl. evaluation of
carcino hazards) %

Human nervous and mental disorder
%

Human Cardiovascular diseases%

s
t
i
b
b
a
R

i

s
r
o
v
n
r
a
C

s
t
n
e
d
o
r

r
e
h
t
O

l

a
y
t
c
a
d
o
s
i
r
r
e
P
+
o
i
t
r

A

s
d
r
i

B

l

s
a
m
m
a
M

r
e
h
t
O

s
e
p
A
+
s
y
e
k
n
o
M
+
s
n
a
m
s
o
r
P

i

i

l

i

s
a
m
n
a
d
e
d
o
o
b
-
d
o
C

l

l

i

s
g
P
-
a
e
n
u
G

i

The top of each bar shows the relative percentage of animals used for studies on specific 
animal  diseases.  Two  groups  of  animals  i.e.  birds  and  cold-blooded  animals  account  for 
more than 80% of such studies. Member States reported that it is still current practice to 
test  vaccines  on  these  types  of  species.  However,  in  some  Member  States  only  birds  are 
used if the infection concerns bird species. 

In 2005, the proportion of other mammals used for specific animal diseases has decreased 
but increased proportionally in studies of other human diseases.  

Overall  the  general  pattern  of  the  proportion  of  animals  used  for  the  studies  of  diseases 
presented very little change when compared to the previous statistical report.  

EN 

40 

   EN

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

III.6.1.  The  data  on  animals  used  in  production  and  quality  control  of  products  for 

human medicine and dentistry and for veterinary medicine 

The  consolidated  table  for  the  25  Member  States  reporting  the  origin  of  the  regulatory 
requirements in relation to animals used for the production and quality control of products 
for human medicine and dentistry and for veterinary medicine (EU Table 5) is presented in 
Table 5.1 of this report. 

III.6.2.  Treatment and interpretation of the data  

The number of animals used in tests for the production and quality control of products for 
human  medicine  and  dentistry  and  for  veterinary  medicine  represents  15,3%  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.  

Figure 5.1
Percentages of animals used for regulatory requirements for the  production and 
quality control of products and devices for human medicine, dentistry and for 
veterinary medicine

0,00

10,00

20,00

30,00

40,00

50,00

60,00

5.2     National legislation
specific to a single EC Member
State

2,56

5.3     EC legislation including
European Pharmacopoeia
(requirements)

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

0,01

5.5    Other legislation

2,10

5.6      Any combination of 5.2/
5.3/ 5.4/ 5.5

 5.7       No regulatory
requirements

5,16

33,31

2005

56,85

The  largest  proportion  of  animals  in  this  area  (57%)  was  used  to  simultaneously  satisfy 
requirements from several legislations such as national, Community, Council of Europe or 
others.  The  testing  carried  out  to  satisfy  the  EU  legislation  including  the  European 
Pharmacopoeia covered 33,3% of the animals used in this area. 

The increase  of the percentage, from 43,1% to 56,8%,  of the number  of animals used to 
satisfy  simultaneously  several  pieces  of  legislation  in  comparison  to  2002,  is  clearly 
showing an encouraging trend. This is likely to reflect a positive increase in harmonisation 
of different legislative requirements. 

Another positive trend is the reduction of the number of animals, from 352,000 to 95,739, 
used for "no regulatory requirements". 

EN 

41 

   EN

 
 
Table 5.1: Number of animals used in the production and quality control of products and devices for human medicine and dentistry 
and for veterinary medicine 
Regulatory requirements versus species 
Data of 2005 * 

5.1. Species 

5.2. 
National 
legislation 
specific to a 
single EC 
Member 
State1 

5.3. EC 
legislation 
including 
European 
Pharmacopoeia 
(requirements) 

1.a. Mice (Mus musculus) 
1.b. Rats (Rattus norvegicus) 
1.c. Guinea-Pigs (Cavia porcellus) 
1.d. Hamsters (Mesocricetus ) 
1.e. Other Rodents (other Rodentia) 
1.f.  Rabbits (Oryctolagus cuniculus) 
1.g. Cats (Felis catus) 
1.h. Dogs (Canis familiaris) 
1.i.  Ferrets (Mustela putorius furo) 
1.j.  Other Carnivores (other Carnivore) 
1.k. Horses, donkeys and cross breds 
(Equidae) 
1.l.  Pigs (Sus) 
1.m. 
1.n. Sheep (Ovis) 
1.o. Cattle (Bos) 
1.p. Prosimians (Prosimia) 
1.q. New World Monkeys (Ceboidea) 
1.r.  Old World Monkeys 
(Cercopithecoidea) 
1.s. Apes (Hominoidea) 
1.t.  Other Mammals (other Mammalia) 

Goats (Capra) 

24912
5551
8558
0
0
2566
76
21
14
0
229

136
0
176
125
0
0
0

0
10

EN 

326864
82479
44713
4528
0
85556
607
1016
30
202
219

4363
4
838
1462
0
35
6

0
60

42 

5.4. 
Member 
Country of 
Council of 
Europe (but 
not EC) 
legislation2)
20
0
7
0
0
0
0
0
0
0
0

0
0
0
26
0
0
0

0
0

5.5. Other 
legislation

5.6. Any 
combination 
of 5.2/ 5.3/ 
5.4/ 5.5 

5.7. No 
regulatory 
requirements

5.8. Total 

13463
18436
6041
0
0
308
13
0
0
0
2

9
0
0
10
0
0
0

0
0

685435
127504
73163
5449
187
87867
111
241
6
0
281

1572
118
3650
533
0
0
357

0
0

36912
6822
3346
395
0
28300
18
148
6
0
1429

1019
3
2284
268
0
8
10

0
0

1087606 
240792 
135828 
10372 
187 
204597 
825 
1426 
56 
202 
2160 

7099 
125 
6948 
2424 
0 
43 
373 

0 
70 

EN 

 
  
1.u. Quail (Coturnix coturnix) 
1.v. Other birds (other Aves) 
1.w. Reptiles (Reptilia) 
1.x. Amphibians (Amphibia) 
1.y. Fish (Pisces) 
1.z. TOTAL 
(*) France reporting for 2004 

0
3913
0
0
1222
47509

Exampl
es: 

5.2  -  France  is  testing  due  to  a  UK  (or  FR) 
specific requirement 
5.3 - UK is testing according to EC legislation 

5.4  -  Spain  is  testing  due  to  a  Hungarian 
requirement 
5.5  -  Sweden  is  testing  due  to  a  US  specific 
requirement 
5.6  -  Germany 
is 
requirement (also an EC requirement) 

to  a  Czech 

testing  due 

0
61303
0
0
3446
617731

Note: 

Example: 

0
152
0
0
0
205

0
683
0
0
0
38965

0
63959
0
0
3971
1054404

0
14181
0
0
590
95739

0 
144191 
0 
0 
9229 
1854553 

columns 5.2 - 5.5 refer to the legislation imposing that the 
test be carried out 
and  not  to  the  body  which  has  issued  the  actual  test 
method, guideline or protocol 
a  test  required  by  French  legislation  and  carried  out  in 
Belgium according to an 
ISO protocol must be coded as a national (FR) legislative 
requirement and be 
entered  into  column  5.2  in  the  tables  submitted  by 
Belgium. 

EN 

43 

EN 

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

animals used in toxicological and other safety evaluations 

III.7.1.  The  data  on  the  origin  of  regulatory  requirements  for  animals  used  in 

toxicological and other safety evaluations  

The  consolidated  table  for  the  25  Member  States  reporting  data  on  animals  used  in 
toxicological  and  other  safety  evaluations  in  relation  to  the  origin  of  regulatory 
requirements (EU Table 6) is presented in Table 6.1 at the end of this chapter. 

III.7.2.  Treatment and interpretation of the data 

It  can  be  observed  that  the  use  of  animals  for  regulatory  requirements  in  the  area  of 
toxicological or other safety evaluation presented in Figure 6.1 follows a similar pattern to 
that  of  the  use  for  regulatory  purposes  in  human  medicine,  dentistry  and  in  veterinary 
medicine presented in the Figure 5.1 in the previous chapter. 

As  pointed  out  earlier,  the  number  of  animals  used  in  toxicological  or  other  safety 
evaluation represents 8% of the total number of animals used for experimental purposes in 
the EU. 

Figure 6.1  
Percentages of animals used for regulatory requirements for toxicological 
and other safety evaluation  

0,00

10,00

20,00

30,00

40,00

50,00

60,00

9,39

23,65

6.2     National legislation
specific to a single EC Member
State

6.3     EC legislation including
European Pharmacopoeia
(requirements)

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

0,12

6.5    Other legislation

3,93

6.6      Any combination of 6.2/
6.3/ 6.4/ 6.5

 6.7       No regulatory
requirements

8,71

54,20

Animals  used  to  simultaneously  satisfy  regulatory  requirements  from  several  pieces  of 
legislation  covered  more  than  half  of  the  animals  used  in  this  area  (54,2%).  The  testing 
required under the EU legislation including the European Pharmacopoeia accounts for the 
second highest percentage in this area namely 23%. 

EN 

44 

   EN 

 
 
It should be underlined that the proportional decrease of the numbers of animals used for 
toxicological and other safety evaluation since the last report, from 10% to 8%, represents 
at  the  same  time  a  decrease  of  about  40,000  animals.  The  number  of  animals  used  "no 
regulatory requirements" decreased since the last report from 114,000 to 90,000 animals, a 
drop of 24,000 animals. 

Member States who were asked to provide some further explanation as to the reasons for 
this clear decrease of animals used for no regulatory requirements compared to previous 
reports,  indicated  that  the  decrease  was  partially  attributed  to  use  of  alternative  in  vitro 
methods  and  invertebrate  animals.  For  example,  safety  pharmacological  tests  such  as 
those used for supplementary batch control by the European Pharmacopoeia. In order to 
understand  what  is  meant  by  the  term  'no  regulatory  requirements',  for  example  some 
Member  States  indicated  that  legal  obligations  to  ensure  quality  and  safety  of  imported 
drugs would be reported under this category. 

The  testing  to  satisfy  national  legislation  specific  to  a  single  Member  State  showed  a 
decrease  in  this  report  with  respect  to  the  previous  one  but  it  represents  about  15,500 
animals i.e. 1,5% of the total number used for toxicological and other safety evaluation. 

EN 

45 

   EN 

 
Table 6.1:  Number of animals used in toxicological and other safety evaluations 

Regulatory requirements versus species 

Data of 2005* 

6.3. EC 
legislation 
including 
European 
Pharmacopoeia 
(requirements) 
104143
61953
21189

6.4. Member 
Country of 
Council of 
Europe (but 
not EC) 
legislation2) 
170 
670 
70 

6.1. Species 

6.2. National 
legislation 
specific to a 
single EC 
Member 
State1) 

1.a. Mice (Mus musculus) 
1.b. Rats (Rattus norvegicus) 
1.c. Guinea-Pigs (Cavia 
porcellus) 
1.d. Hamsters (Mesocricetus ) 
1.e. Other Rodents (other 
Rodentia) 
1.f.  Rabbits (Oryctolagus 
cuniculus) 
1.g. Cats (Felis catus) 
1.h. Dogs (Canis familiaris) 
1.i.  Ferrets (Mustela putorius 
furo) 
1.j.  Other Carnivores (other 
Carnivore) 
1.k. Horses, donkeys and cross 
breds (Equidae) 
1.l.  Pigs (Sus) 
1.m. 
1.n. Sheep (Ovis) 
1.o. Cattle (Bos) 
1.p. Prosimians (Prosimia) 
1.q. New World Monkeys 

Goats (Capra) 

39972
19368
1009

0
0

1398

166
977
0

0

0

57
0
4
12
0
0

182
300

9462

46
1919
0

0

5

1150
26
120
320
97
0

6.5. Other 
legislation

6.6. Any 
combination 
of 5.2/ 5.3/ 
5.4/ 5.5 

6.7. No 
regulatory 
requirements

6.8.Total 

15039
15875
2052

0
0

189776
224860
27849

1204
0

37144
25772
1329

386244 
348498 
53498 

284
583

1670 
883 

0 
0 

13 

2653

23162

2420

39108 

0 
0 
0 

0 

0 

0 
0 
0 
0 
0 
0 

6
520
0

0

0

132
0
0
15
0
0

4
10842
41

0

25

1642
3
191
203
0
599

23
324
0

0

10

266
44
108
107
0
51

245 
14582 
41 

0 

40 

3247 
73 
423 
657 
97 
638 

EN 

46 

EN 

 
  
(Ceboidea) 
1.r.  Old World Monkeys 
(Cercopithecoidea) 
1.s. Apes (Hominoidea) 
1.t.  Other Mammals (other 
Mammalia) 
1.u. Quail (Coturnix coturnix) 
1.v. Other birds (other Aves) 
1.w. Reptiles (Reptilia) 
1.x. Amphibians (Amphibia) 
1.y. Fish (Pisces) 
1.z. TOTAL 
(*)France reporting for 2004 

0

0
0

0
5519
12
542
27338
96374

304

0
15

2124
4787
0
0
34565
242707

0 

0 
0 

0 
0 
0 
0 
312 
1235 

488

5312

153

6257 

0
0

0
522
0
0
3029
40331

0
0

1037
38262
0
0
31210
556222

0
0

0 
15 

3186 
25
50744 
1654
12 
0
542 
0
19120
115574 
89417 1026286 

Example
s: 

6.2  -  France  is  testing  due  to  a  UK  (or  FR)  specific 
requirement 
6.3 - UK is testing according to EC legislation 
6.4 - Spain is testing due to a Hungarian requirement 

6.5 - Sweden is testing due to a US specific requirement 

6.6 - Germany is testing due to a Czech requirement (also 
an EC requirement) 

Note: 

Exam
ple: 

columns 6.2 - 6.5 refer to the legislation imposing that 
the test be carried out and not to the body which has 
issued the actual test method, guideline or protocol 
a test required by French legislation and carried out in 
Belgium according to an  
ISO  protocol  must  be  coded  as  a  national  (FR) 
legislative requirement and be 
entered  into  column  6.2  in  the  tables  submitted  by 
Belgium. 

EN 

47 

EN 

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

evaluations 

III.8.1.  The data on animals used in toxicity test for toxicological and other safety evaluations 

The consolidated table for the 25 Member States reporting on animals used in toxicity tests for the 
purpose of toxicological and other safety evaluations of products (EU Table 7) is presented in Table 
7.1 at the end of this chapter. 

III.8.2.  Treatment and interpretation of the data 

For the convenience of the presentation of results some of the toxicity tests of Table 7.1 have been 
grouped  according  to  systemic  and  local  toxicity  and  CMR  effects  in  Table  7.2  of  this  report.  A 
graph showing the percentage of animals used per toxicity test groups in 2005 is presented in Figure 
7.1. 

Figure 7.1
Percentages of animals used in toxicity tests for toxicological
 and other safety evaluation

0,00

10,00

20,00

30,00

40,00

50,00

42,01

Acute and sub-acute
toxicity testing methods
(including limit test)

Irritation /sensitization
tests

5,88

 Sub- chronic and chronic
toxicity

10,90

Mutagenicity and
carcinogenicity

7,55

Reproductive and
developmental toxicity

10,11

Toxicity to aquatic
vertebrates not included in
other columns

1,24

other

22,32

As pointed out in the previous chapter, the number of animals used in toxicological and other safety 
evaluation represents 8% of the total number of animals used for experimental purposes. 

EN 

48 

   EN 

 
 
It can be seen in Figure 7.1 that the largest percentage of use of animals is due to acute and sub-
acute  toxicity  tests  42%  in  2005.  Taking  also  into  account  sub-chronic  and  chronic  toxicity,  the 
percentage of animals used in short and long term systemic toxicity testing accounts for 53% of the 
experimental animals used in this area.  

About  17,5%  of  animals  were  used  for  testing  carcinogenicity,  mutagenicity  and  toxicity  to 
reproduction in 2005. Another important category of use of animals in 2005 is for "other tests" with 
22,3%. Breaking down further the category 'other', Member States reported testing in areas such as 
biological  screening  for  pharmaceutical,  healthcare  and  veterinary  products.  This  includes 
neurotoxicity,  toxicokinetics,  testing  of  acute  dermal  toxicity,  testing  of  biological  evaluation  of 
medical  devices:  Intracutan  testing  of  reactivity  on  rabbits,  study  into  penetration  of  nanoparticle 
through  tissue  and  their  biocompatibility,  study  into  evaluation  of  sensitization  potential  of 
dyestuffs used in textile industry and pharmacological studies included in safety tests. 

By  looking  both  in  numbers  and  relative  percentages  of  use  of  animals  in  comparison  to  the 
previous reports there are three noticeable changes: 

One can observe a continuous increase over the last three reports of the proportion of animals used 
for  acute  and  sub-acute  tests  ranging  from:  32%,  36%  to  42%  respectively.  This  represents  in 
animal  numbers  an  increase  of  39,000  animals  since  the  last  report  of  2002.  Member  States 
attributed the increase in part to several phases in new product development and new legislation for 
example requiring that all generic substances should be tested.  

On the other hand one can observe a steady decrease over the last three reports of the proportion of 
animals used for toxicity tests to reproduction going down from: 15%, 12% to 10% respectively. 

Another important decrease in the proportion of animals used is the decrease from 4,5% to 1,2% of 
animals used in toxicity test to aquatic vertebrates.  

Some  Member  States  presume  that  the  decrease  in  regulatory  testing  can  indeed  be  attributed  to 
alternative methods but others think that replacement methods have a much greater impact on R&D 
than on regulatory requirements. They point out that the statistics drawn up annually include re-use 
of animals which plays an important role.  

EN 

49 

   EN 

 
Table 7.1: Number of animals used in toxicological and other safety evaluations 

Type of tests versus species 
Data of 2005* 

7.1. Species 

7.2. Acute and sub-acute 
toxicity testing methods 
(including limit test) 

7.3. 
Skin 
irritati
on 

7.5. 
Eye 
irritati
on 

7.4. 
Skin 
sensi
tisati
on 

7.6. 
Sub- 
chroni
c and 
chroni
c 
toxicity

7.7. 
Carci
no- 
genic
ity 

7.8. 
Devel
op- 
mental 
toxicity

7.9. 
Muta- 
genic
ity 

7.12. 
Other 

7.13. 
Total 

7.10. 
Repr
o-
ducti
ve 
toxicit
y 

7.11. 
Toxicity 
to 
aquatic 
vertebr
a-tes 
not 
include
d in 
other 
column
s 

7.2.1. 
LD50, 
LC50 

7.2.2. 
Other 
lethal 
metho
ds 

1.a. Mice (Mus musculus) 

33024  86669

7.2.3. 
Non 
lethal 
clinical 
signs 
method
s 
68682

2805

1.b. Rats (Rattus norvegicus) 

19756  18614

78707

1156

1.c. Guinea-Pigs (Cavia 
porcellus) 
1.d. Hamsters (Mesocricetus ) 
1.e. Other Rodents (other 
Rodentia) 
1.f.  Rabbits (Oryctolagus 
cuniculus) 
1.g. Cats (Felis catus) 

1415 

993

17572

2144

603
300

0
0

0 
56 

36 

0 

64
142

49

0

2135
0
303

2218
4
0
0

0

25550

142

65466

0

0
0

628

38
300

2944

5130

52

4033

1693

108

0

0

0

0

EN 

50 

1962
4
2240
0
0

0
0

0

0

2612

23886

0

0
0

1947
9
1572
7
0

20
0

908

5151
8
0

0
0

8078

31

4640

0

0

0

0

0

0

0
0

0

0

1055
41 
5082
9 

38624
4 
34850
4 
8556  53492 

945 
40 

1670 
838 

1246
7 
114 

39153 

222 

EN 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
Goats (Capra) 

1.h. Dogs (Canis familiaris) 
1.i.  Ferrets (Mustela putorius 
furo) 
1.j.  Other Carnivores (other 
Carnivore) 
1.k. Horses, donkeys and 
cross breds (Equidae) 
1.l.  Pigs (Sus) 
1.m. 
1.n. Sheep (Ovis) 
1.o. Cattle (Bos) 
1.p. Prosimians (Prosimia) 
1.q. New World Monkeys 
(Ceboidea) 
1.r.  Old World Monkeys 
(Cercopithecoidea) 
1.s. Apes (Hominoidea) 
1.t.  Other Mammals (other 
Mammalia) 
1.u. Quail (Coturnix coturnix) 
1.v. Other birds (other Aves) 

182 
0 

659
0

5170
41

0 

0 

8 
0 
0 
0 
0 
0 

0 

0 
0 

0

0

49
0
0
0
0
85

1

0
0

0

10

304
0
32
73
60
222

2014

0
0

0
0

0

0

8
0
0
0
0
0

0

0
0

2253 
1671 

348
260

105
11403

0
1000

1.w. Reptiles (Reptilia) 
1.x. Amphibians (Amphibia) 
1.y. Fish (Pisces) 

0 
0 

0
0
54830  10449

0
0
11146

0
0
0

0
0

0

0

0
0
0
0
0
0

0

0
0

0
0

0
0
0

0
0

0

0

0
0
0
0
0
0

6998
0

0

0

971
0
0
0
32
185

33

3406

0
0

0
0

0
0
0

0
0

0
158

0
0
6443

0
0

0

0

0
0
0
0
0
0

0

0
0

0
0

0
0
0

1.z. TOTAL 

11323
1 

11838
2

199496

1224
3

4388
9

4208

11186
8

4202
4

(*) France reporting for 2004 

0
0

0

0

89
0
35
0
0
90

131

0
0

0
0

0
42
5484

40447

0
0

0

0

0
0
0
0
0
0

0

0
0

0
0

0
0
226

29
0

0

0

100
0
37
0
0
0

187

0
0

480
128

0
0
5284

3548
3

6331
1

0
0

0

0

0
0
0
0
0
0

0

0
0

0
0

0
0
12675

12675

1567  14605 
41 

0 

0 

30 

1718 
39 
353 
584 
5 
68 

0 

40 

3247 
39 
457 
657 
97 
638 

485 

6257 

0 
15 

0 
15 

3186 
50744 

0 
3612
4 
12 
500 

12 
542 
9037  11557
4 
10262
86 

2290
29 

EN 

51 

EN 

 
  
Table 7.2: Grouping of certain type of tests on animals of table 7.1   

7.1. Species 

1.a. Mice (Mus musculus) 
1.b. Rats (Rattus norvegicus) 
1.c. Guinea-Pigs (Cavia 
porcellus) 
1.d. Hamsters (Mesocricetus ) 
1.e. Other Rodents (other 
Rodentia) 
1.f.  Rabbits (Oryctolagus 
cuniculus) 
1.g. Cats (Felis catus) 
1.h. Dogs (Canis familiaris) 
1.i.  Ferrets (Mustela putorius 
furo) 
1.j.  Other Carnivores (other 
Carnivore) 
1.k. Horses, donkeys and cross 
breds (Equidae) 
1.l.  Pigs (Sus) 
1.m. 
1.n. Sheep (Ovis) 
1.o. Cattle (Bos) 
1.p. Prosimians (Prosimia) 

Goats (Capra) 

Acute and 
sub-acute 
toxicity testing 
methods 
(including limit 
test) 

188375
117077
19980

667
498

3029

108
6011
41

0

10

361
0
32
73
60

Irritation 
/sensitization 
tests 

 Sub- 
chronic 
and 
chronic 
toxicity 

Mutagenicity 
and 
carcinogenicity

Reproductive 
and 
developmental 
toxicity 

24155
1601
24328

0
0

9215

0
0
0

0

0

8
0
0
0
0

25550 
65466 
628 

39103
38127
0

38 
300 

1693 

0 
6998 
0 

0 

0 

971 
0 
0 
0 
32 

20
0

31

0
0
0

0

0

0
0
0
0
0

3520
75404
0

0
0

12718

0
29
0

0

0

189
0
72
0
0

EN 

52 

Toxicity to 
aquatic 
vertebrates 
not 
included in 
other 
columns 
0
0
0

0
0

0

0
0
0

0

0

0
0
0
0
0

other 

Tot

105541 
50829 
8556 

945 
40 

386
348
53

1

12467 

39

14

3

114 
1567 
0 

0 

30 

1718 
39 
353 
584 
5 

EN 

 
  
 
1.q. New World Monkeys 
(Ceboidea) 
1.r.  Old World Monkeys 
(Cercopithecoidea) 
1.s. Apes (Hominoidea) 
1.t.  Other Mammals (other 
Mammalia) 
1.u. Quail (Coturnix coturnix) 
1.v. Other birds (other Aves) 
1.w. Reptiles (Reptilia) 
1.x. Amphibians (Amphibia) 
1.y. Fish (Pisces) 
1.z. TOTAL 

307

2015

0
0

2706
13334
0
0
76425
431109

0

33

0
0

0
1000
0
0
0
60340

185 

3406 

0 
0 

0 
158 
0 
0 
6443 
111868 

0

0

0
0

0
0
0
0
226
77507

90

318

0
0

480
128
0
42
10768
103758

0

0

0
0

0
0
0
0
12675
12675

68 

485 

0 
15 

0 
36124 
12 
500 
9037 
229029 

6

3
50

115
1026

EN 

53 

EN 

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

and other safety evaluations of products 

III.9.1.  The  data  on  type  of  toxicity  tests  carried  out  for  toxicological  and  other 

safety evaluations of products 

The  consolidated  table  for  the  type  of  toxicity  tests  carried  out  for  toxicological  or 
other safety evaluations of products, for the 25 Member States reporting (EU Table 8) 
is  presented  in  Table  8.1  of  this  report.  There  are  discrepancies  between  the  total 
numbers of animals per types of tests in Table 7 in comparison with the total numbers 
of  animals  per  types  of  tests  of  Table  8.  Logically  these  should  be  the  same.  These 
discrepancies  originate  from  10  Member  States;  however,  when  the  data  was 
submitted  no  explanation  was  given  as  to  the  reasons.  The  overall  total  number  of 
animals for toxicological and other safety evaluations remains coherent. 

III.9.2.  Treatment and interpretation of the data 

As  pointed  out  earlier  it  is  important  to  keep  in  mind  that  animals  used  in 
toxicological and other safety evaluation represent 8% of the total number of animals 
used  for  experimental  purposes.  The  treatment  and  interpretation  of  the  data  on 
animals used for toxicity tests with regard to the type of products has not been done in 
the previous reports due to inconsistencies in the data in the past. The results in this 
area are therefore analysed and compared in this report for the first time.  

Figure 8.1 represents the percentages of the number of animals used in toxicological 
testing or other safety evaluations in relation to the type of products or purposes. In 
order to give a better graphical presentation of the results, some type tests have been 
grouped  according  to  systemic  and  local  toxicity  and  carcinogenic,  mutagenic  and 
toxicity to reproduction effects in Table 8.2 of this report.  

EN 

54 

   EN

 
Figure 8
Percentages of animals used for toxicity tests for toxicological and 
other safety evaluation by types of products

 A) for human medicine, dentistry and for
veterinary medicine   

B) used  in agriculture

C) used in industry

D) used  in the household

E) used as cosmetics or  toiletries

F) additives in food for human consumption

G) additives in food for animal consumption

H) potential  or actual contaminents in the
general environment 

I)  other  toxicological or safety evaluations

0% 20% 40% 60% 80% 100%

  Acute and sub-acute toxicity
testing methods (including limit
test)
Irritation/sensitization tests

Sub- chronic and chronic toxicity

Mutagenicity and carcinogenicity

Reproductive and developmental
toxicity

Toxicity to aquatic vertebrates not
included in other columns

Other

Figure 8.1 shows a decrease in the proportion of animals used in acute and sub-acute 
toxicity  tests  in  comparison  with  other  tests  when  moving  down  in  the  graph  for 
products  used  A)  for  human  medicine,  dentistry  and  veterinary  medicine,  B)  for 
agriculture,  C)  for  industry,  D)  for  household,  E)  for  cosmetics,  F)  for  additives  in 
food consumption and G) for additives in food for animal consumption. However, the 
animals  used  in  acute  and  sub-acute  toxicity  tests  for  other  toxicological  and  safety 
evaluations would benefit from further analysis.  

Contrary to acute and sub-acute toxicity one can observe an increase in the proportion 
of  animals  used  for  irritation  and  sensitization  tests.  While  further  down  the  graph 
amongst the four first types of products, a maximum amount of testing takes place for 
products used in cosmetics and toiletries.  

The proportion of animals used in sub-chronic and chronic testing seems to follow the 
same pattern as for irritation sensitization tests with the highest proportion used for D) 
household products and F) additives in food for human consumption.  

The pattern of use of carcinogenicity, mutagenicity and toxicity to reproduction tests 
is  rather  scattered  between  the  different  types  of  products  and  more  difficult  to 
interpret.  

EN 

55 

   EN

 
The  proportion  of  animals  used  for  G)  additives  in  food  for  animal  consumption  is 
governed by about 90% by other tests. This group would benefit from further analysis. 

EN 

56 

   EN

 
Table 8.1:  Number of animals used in toxicological and other safety evaluations 
Type of tests versus products 

8.1. Products 

8.2. Acute and sub-acute 
toxicity testing methods 
(including limit test) 

Data of 2005* 

8.3. 
Skin 
irritati
on 

8.4. 
Skin 
sensiti
sation

8.5. 
Eye 
irrita
tion 

8.6. 
Sub- 
chronic 
and 
chronic 
toxicity 

8.7. 
Carci
no- 
genici
ty 

8.8. 
Devel
op- 
ment
al 
toxicit
y 

8.9. 
Muta- 
genic
ity 

8.10. 
Repr
o-
ducti
ve 
toxicit
y 

8.12. 
Other 

8.13. 
Total 

8.11. 
Toxicity 
to 
aquatic 
vertebr
a-tes 
not 
include
d in 
other 
column
s 

8.2.1. 
LD50, 
LC50 

8.2.2. 
Other 
lethal 
metho
ds 

8.2.3. 
Non 
lethal 
clinical 
signs 
method
s 

8.a. Products/ substances or 
devices for human medicine 
and dentistry and for 
veterinary medicine  
8.b. Products/ substances 
used or intended to be used 
mainly in agriculture 
8.c. Products/ substances 
used or intended to be used 
mainly in industry 

18820  38091 155459

4097 15296

145
2

67651

2658
9

1823
8

2100
5

3078
8

3419  1272
84 

52818
9 

21368 

5956

11467

872

6486

654

12535

3100

1015
8

1831

18963 

4047

13416

4743

9264

111
1

13177

2644

3230

8371

1259
9

1004
3

1847  8687  97560 

2136  5684  96829 

EN 

57 

EN 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
8.d. Products/ substances 
used or intended to be used 
mainly in the household 
8.e. Products/ substances 
used or intended to be used 
mainly as cosmetics or 
toiletries 
8.f. Products/ substances 
used or intended to be used 
mainly as additives in food 
for human consumption 
8.g. Products/ substances 
used or intended to be used 
mainly as additives in food 
for animal consumption 
8.h. Potential or actual 
contaminants in the general 
environment which do not 
appear in other columns 
8.i. Other toxicological or 
safety evaluations 
8.j. TOTAL 

(*) France reporting for 2004

20 

18

11

48

154

70

568

0 

349

684

469

2222

300

966

3

0

0

0

51

368

213

0

0

0 

276 

1219 

0 

0 

5571 

0

239

1210

0 

572 

5221 

1767

6 

40

1283

3

98

0 

907

239

30

32120 

9894

5959

0

0

0

3

0

0

160

24

0

0

423

0  3169
2 

33475 

3793

7045

4541

594

5393

6524  7885  83748 

20974  58282

8840

668

4921

478

23062

1459

2756

4836

2088

112271  11758
4

197358 10930 38441

406
8

123679

4086
4

3929
1

3714
0

6254
4

4593  4151
7 
18519  2235
97 

17447
4 
10262
86 

EN 

58 

EN 

 
  
Table 8.2: Number of animals used in toxicological and other safety evaluation per types of products 

8.1. Products 

8.a. Products/ substances or 
devices for human medicine 
and dentistry and for 
veterinary medicine  
8.b. Products/ substances 
used or intended to be used 
mainly in agriculture 
8.c. Products/ substances 
used or intended to be used 
mainly in industry 
8.d. Products/ substances 
used or intended to be used 
mainly in the household 
8.e. Products/ substances 
used or intended to be used 
mainly as cosmetics or 
toiletries 
8.f. Products/ substances 
used or intended to be used 
mainly as additives in food for 
human consumption 

Acute 
and sub-
acute 
toxicity 
testing 
methods 
(including 
limit test) 
212370

38791

36426

49

1033

1329

Irritation/sensitization 
tests 

Sub- 
chronic 
and 
chronic 
toxicity 

Mutagenicity 
and 
carcinogenicity

Reproductive 
and 
developmental 
toxicity 

Other 

Total 

Toxicity 
to 
aquatic 
vertebra-
tes not 
included 
in other 
columns 

20845

67651

47594

49026

3419 127284 

528189 

8012

12535

4931

22757

1847

8687 

97560 

15118

13177

11015

13273

2136

5684 

96829 

272

568

2991

966

54

213

0

368

104

1767

239

1210

0

0

0

276 

1219 

0 

5571 

572 

5221 

EN 

59 

EN 

 
  
8.g. Products/ substances 
used or intended to be used 
mainly as additives in food for 
animal consumption 
8.h. Potential or actual 
contaminants in the general 
environment which do not 
appear in other columns 
8.i. Other toxicological or 
safety evaluations 
8.j. TOTAL 

1146

30

160

24

423

0

31692 

33475 

47973

0

3793

7639

9934

6524

7885 

83748 

88096

427213

6067

23062

6295

4844

4593

41517 

174474 

53439 123679

78004

101835

18519 223597  1026286 

EN 

60 

EN