EN    EN  COMMISSION OF THE E UROPEAN 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 Nu mber of Animals used for Experimental and 
other Scientific Purposes in the Member States of the European Union 
  
{COM (2007) 675 final}
 
EN 2   EN 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  
II.3. Structure of the Report................................................................................................. 6  
PART A: COMPILATION AND OVERVI EW 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 den tistry 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 carri ed out for toxicological and 
other safety evaluations of products .......................................................................... 54 
 
EN 3   EN 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 admini strative provisions of the Member States 
regarding the protection of animals used for experimental and othe r 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 statistica l reports published in 19942 and 19993 covering data on 
experimental animals collect ed in 1991 and 19 96 respectively provi ded 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 Me mber States and the Commission to submit 
data for the future reports under a format of eight harmonized tabl es. The third and the 
fourth statistical re ports published in 2003
4 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 statistic al 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 accomp anies 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 Purpos es in the Member Stat es of the European 
Union”. The report summarizes the data and co nclusions presented in  this Staff Working 
Document. 
                                                
 
1 OJ L 358, 18.12.1986, p.1.  
2 COM (94) 195 final  
3 COM (1999) 191 final  
4 COM (2003) 19 final  
5 COM (2005) 7 final  
 
EN 4   EN II. DATA SUBMITTED A ND 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 th e Member States is essentially governed by 
four criteria based on certai n relationship between the data  in the different tables. 
– The first of these relationships is the tota l 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 safe ty evaluation” which is br oken down into types of 
products/endpoints, EU Table 3, into Regulat ory requirements, EU Table 6, and into 
types of toxicological tests, EU Table 7. Th e 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, th e total row of EU table 3 “an imals 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 consid ered 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 representa tives of the Governments of the Member 
States of the European Communities, mee ting within the Council of 24 November 1986 
regarding the protection of animals used for experimental  and other scientific purposes
6 
allows the use of animals in experiment s for education and training, but where the 
purposes of such experiments are not cove red 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 wh ich 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.  
 
EN 5   EN The first part of this report aims at provi ding a comprehensive overview on the numbers of 
animals used for various experimental purpos es in the Community in 2005. The analysis 
will look at the purposes of the use of anim als. 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 t ype 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 da ta 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 chan ges in use will be highlighted in the report.  
The number of animals used in the 10 new Me mber 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 s how 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 da ta of EU 15 and Table 
1tris with the data of EU 10 have been prepared to see th e effects of the new Member 
States on the EU statistics. Furthermore, an at tempt will be made to compare the results of 
the total number of animals used in 2005 with in 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 fo r 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 rodent s 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 an imals 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. 
 
EN 6   EN II.3. Structure of the Report 
The report is divide d into two parts: 
A A global compilation and overview for the Eu ropean 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 comp lete 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 ne vertheless made on th is 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 ar e linked to the numbers of the EU Tables 
and not to the numbering of th e chapters of the report.  
B The data submitted by each Member State with a summary of the Member State’s 
comments.  
 
EN 7   EN PART A: COMPILATION AND OV ERVIEW 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 rela ting to the total number of an imals used subdivided into 25 
species by the Member States. The second is re lating 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 repo rt 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 (F rance 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 (E U 10) represents 8,6% of the total number of 
animals in the EU 25. This proportion will be us ed as the basis to highlight any changes in 
trends which significan tly deviate from it.  
III.1.2. Treatment and interpreta tion of the data of Table 1.1 
In order to present an overall evaluation an d subsequently a graphi cal analysis, animals 
were grouped in classes. The result of this exer cise is presented in Table 1.2 at the end of 
this chapter. Table 1.2 is illustrated by Figure 1.1. 
 
EN 8   EN Figure 1.1
Percenta ges of animals used b y classes b y the reportin g 
Member States 
Mice 53%
Rats 19%Guinea-Pigs 2,1%Other rodents 0,8% Rabbits 2,6%Cold-blooded  animals 
15% Birds 5,4%Artio+perissodactyla 
1,1% Carnivores 0,33% Prosimians+Monkeys+
Apes 0,09%
Other mammals 0,08%
 
Rodents together with rabbits represent 77,5% of the total numb er 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 represen ted by cold-blooded animals with 15%. 
Birds is the next highest an imal group being used for expe rimental purposes with 5,4% 
The Artio and Perissodactyla group incl uding 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 numbe r 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 dea ling 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. Nevert heless, 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 co mparing 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 1996(*) 1999 2002(**) 2005(***) 
% Rodents-rabbits 81,3 86,9 78,0 77,5 
% Cold-blooded 
animals 12,9 6,6 15,4 15, 
 
EN 9   EN % Birds  4,7 5 5,4 
% Artio Perissodactyla  1,2 1,2 1,1 
(*) 14 Member States r eporting for 1996, one for 1997 
(**) 14 Member States r eporting 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 perissodact yla fluctuates around 1%. 
The inclusion of the data of th e new Member States (EU 10) s hould in principle increase the 
actual numbers of animals of each species with the magnit ude 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 change s in total numbers. More substantial overall 
changes have been highlighted and in partic ular any changes among EU 15 contrary to the 
overall change. 
 
EN 10   EN 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.  
2002Animal
numbe
rs 
in EU 
15 
2005 Chang
e 
since 
2002 
in EU 
15 %ch
ang
e 
sinc
e 
200
2 
in 
EU 
15 
1.a Mice (Mus musculus) 64303
46 54597
299706
1717,8 60388
46 57911
7 10,6
1.b Rats (Rattus 
norvegicus) 23360
32 23113
442468
81,1 21304
46 -
18089
8 -7,8
1.c Guinea-Pigs (Cavia 
porcellus) 25730
7 22633
93096
813,7 23318
0 6841 3,0
1.d Hamsters 
(Mesocricetus ) 31535 52382 -
2084
7-
39,830935 -
21447 -
40,9
1.e Other Rodents (other 
Rodentia) 64474 58827 5647 9,6 47451 -
11376 -
19,3
1.f Rabbits (Oryctolagus 
cuniculus) 31268
1 26767
54500
616,8 29315
6 25481 9,5
1.g Cats (Felis catus) 3898 3808 90 2,4 3624 -184 -4,8
1.h Dogs (Canis 
familiaris) 24119 21116 3003 14,2 22010 894 4,2
1.i Ferrets (Mustela 
putorius furo) 2690 2078 612 29,4 2512 434 20,1
1.j Other Carnivores 8711 3110 5601 180,
11734 -1376 -
44,2
1.k Horses, donkeys and 
cross breds (Equidae) 5312 4677 635 13,6 4310 -367 -7,8
1.l Pigs (Sus) 66305 61164 5141 8,4 56657 -4507 -7,4
1.m Goats (Capra) 2146 3016 -870 -
28,81958 -1058 -
35,1
1.n Sheep (Ovis) 30021 30979 -958 -3,1 26840 -4139 -
13,4
1.o Cattle (Bos) 36271 26569 9702 36,5 21694 -4875 -
18,3
1.p Prosimians 
(Prosimia) 677 1095 -418 -
38,2677 -418 -
38,2
1.q New World Monkeys 
(Ceboidea) 1564 1192 372 31,2 1564 372 31,2
1.r Old World Monkeys 
(Cercopithecoidea) 8208 8075 133 1,6 8151 76 0,9
1.s Apes (Hominoidea) 0 0 0 0 0 0 0
 
EN 11   EN 1.t Other Mammals 
(other Mammalia) 9950 3618 6332 175,
04701 1083 29,9
1.u Quail (Coturnix 
coturnix) 9246 12984 -3738 -
28,87212 -5772 -
44,4
1.v Other birds (other 
Aves) 64981
3 52198
31278
3024,5 44528
1 -
76702 -
14,7
1.w Reptiles (Reptilia) 2477 3168 -691 -
21,8853 -2315 -
73,1
1.x Amphibians 
(Amphibia) 74620 59689 1493
125,0 59402 -287 -0,5
1.y Fish (Pisces) 17491
78 15864
031627
7510,3 16271
03 40700 2,6
1.z TOTAL 12117
583 10731
0201386
56312,9 11070
299 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 ha s, however, been noted in th e 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 th ese 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 us e 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 th e areas of agricultural and animal breeding 
specific to that Member State. Fo r further details see section B. 
Among the other significant incr eases 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 ferre ts, 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 ma y be attributed to changes in regulatory 
requirements for pharmaceuticals and in toxicological safety testing .  
As in 2002, no great apes were used for experime ntal or other scientific purposes in 2005. 
III.1.4. Comparison with the data of th e previous reports for the EU 15 
Since the total number of animals includes the da ta from the 10 new Member States it is not 
possible to draw a comparison per se  with the results of the pr evious reports. However, to 
allow for some comparisons of trends of the anim al 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. 
 
EN 12   EN In EU 15, the total number of animals used increased in 2005 by 339,279 which represents 
an increase of 3,1% w ith regard to 2002. 
By examining the data by species, the major in crease observed in 2005 is the additional use 
of about 579,000 mice (10,6%). However this incr ease of mice is partly compensated by a 
decrease of the number of rats, hamsters and ot her 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 cha nges 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 al l species, within the class of artio and perissodactyla have 
decreased in comparison to 2002. The same is obs erved with birds. Finally, one can observe 
a substantial decrease of 73%  in the use of reptiles.  
Further breaking down the category 'other', Me mber States reported use of the following 
species:  
Other rodents:  gerbils, old world jerboas ( Jaculus jaculus ); chinchilla, beaver, ground 
squirrel, hamsters, aremenio (Cricetulus mi gratorius) and different species of mice; 
Other carnivores:  wild-life species used for zoologica l 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-w hite quail, poultry species, and zebra 
finches, canary, parakeet, parrot and fa rmed avian species for example, ( Gallus gallus 
domesticus ) 
 
EN 13   EN Table 1.1: Total number of anima ls used for experimental purposes  in the EU Member States 
Data of 2005 (*)  
Species AT BE CY CZ DE DK EL ES EE FR HU IE IT LV LT LU MT NL 
1.a. Mice 128634 488125 967 82252 1084358 208375 15340 393217 4350 1510334 138312 17776 534614 10480 5116 3280 0 240048 
1.b. Rats  11920 106483 0 31703 435417 85664 6024 125754 484 424387 109479 7722 279774 2376 493 720 0 116608 
1.c. Guinea-
Pigs 3149 39530 0 4075 37761 5046 574 16780 0 79350 8360 4 11533 297 0 100 0 7479 
1.d.Hamsters 117 1874 0 220 7916 402 0 908 0 8691 137 0 1537 0 0 0 0 5322 
1.e. Other 
Rodents  107 2260 0 5798 7622 6381 40 294 0 12683 381 0 2303 0 0 0 0 3089 
1.f. Rabbits 18439 21159 0 5567 103329 5805 1255 11878 66 93282 9152 379 9916 166 158 20 0 8251 
1.g. Cats  12 81 0 29 1023 16 0 168 0 1313 124 119 30 0 0 0 0 334 
1.h. Dogs 85 1295 0 264 4868 566 14 685 0 5539 1206 167 1064 0 0 0 0 1049 
1.i. Ferrets 0 154 0 159 560 19 0 237 0 155 0 0 0 0 0 0 0 256 
1.j. Other 
Carnivores  0 0 0 7 235 242 0 0 0 0 0 0 0 0 0 0 0 151 
1.k. Horses, 
donkeys and cross breds 71 108 0 314 755 62 1 42 0 223 6 189 63 0 0 0 0 1705 
1.l. Pigs 818 1876 0 1392 13166 7697 448 4818 0 6587 882 382 2579 0 0 0 0 9853 
1.m.
 Goats 44 157 0 56 275 199 0 119 0 442 2 0 20 0 0 0 0 328 
1.n. Sheep 195 445 0 720 3517 156 99 821 0 4992 381 601 584 0 0 0 0 2667 
1.o. Cattle  536 944 0 711 2909 489 0 294 0 1296 32 2109 1174 0 0 0 0 4410 
1.p.
 Prosimia
ns 0 0 0 0 99 0 0 0 0 578 0 0 0 0 0 0 0 0 
1.q. N W 
Monkeys  0 0 0 0 408 0 0 1 0 433 0 0 17 0 0 0 0 50 
 
EN 14   EN 1.r. O W 
Monkeys 56 449 0 51 1579 0 1 81 0 2778 6 0 395 0 0 0 0 277 
1.s Apes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
1.t. Other 
Mammals  0 59 0 188 115 185 0 60 0 0 0 48 68 0 0 0 0 13 
1.u. Quail 14 425 0 30 2457 0 0 1 0 4023 283 0 0 0 0 0 0 152 
1.v. Other 
birds 1011 13266 0 126211 39150 7784 21 8424 0 102240 17151 2024 31697 0 0 0 0 111081 
1.w. Reptiles  40 144 0 1475 136 54 0 10 0 0 25 0 378 0 0 0 0 7 
1.x.
 Amphibia
ns 865 6177 0 293 10432 840 975 419 0 15675 1709 0 4636 0 0 0 0 3231 
1.y. Fish 1199 33965 0 69418 64337 35958 901300 30584 0 50397 9581 6420 14584 0 0 0 0 14838 
1.z. TOTAL 167312 718976 967 330933 1822424 365940 926092 595597 4900 2325398 297209 37940 896966 13319 5767 4120 0 531199 
(*) France reporting for 2004 
 
EN 15   EN Table 1.1 Bis: Total num ber of animals used for experimental purposes in the 15 EU Member States reporting before 2005 
Data of 2005 (*) 
Species AT BE DE DK EL ES FR IE IT LU NL PT FI SE UK T
1.a. Mice 128634 488125 1084358 208375 15340 393217 1510334 17776 534614 3280240048 28318 120636 213727 1052064 6 0
1.b. Rats  11920 106483 435417 85664 6024 125754 424387 7722 279774 720 116608 6793 28358 83321 411501 2 1
1.c. Guinea-
Pigs 3149 39530 37761 5046 574 16780 79350 4 11533 100 7479 379 563 2014 28918 2
1.d.
 Hamster
s 117 1874 7916 402 0 908 8691 0 1537 0 5322 129 126 167 3746 
1.e. Other 
Rodents  107 2260 7622 6381 40 294 12683 0 2303 0 3089 0 3187 1269 8216 
1.f. Rabbits 18439 21159 103329 5805 1255 11878 93282 379 9916 20 8251 594 1214 2112 15523 2
1.g. Cats  12 81 1023 16 0 168 1313 119 30 0 334 0 0 220 308 
1.h. Dogs 85 1295 4868 566 14 685 5539 167 1064 0 1049 36 103 1166 5373 
1.i. Ferrets 0 154 560 19 0 237 155 0 0 0 256 0 80 47 1004 
1.j. Other 
Carnivores  0 0 235 242 0 0 0 0 0 0 151 0 5 163 938 
1.k. Horses, 
donkeys and crossbreeds 71 108 755 62 1 42 223 189 63 0 1705 8 125 650 308 
1.l. Pigs 818 1876 13166 7697 448 4818 6587 382 2579 0 9853 113 1471 2722 4127 
1.m.
 Goats 44 157 275 199 0 119 442 0 20 0 328 4 73 23 274 
1.n. Sheep 195 445 3517 156 99 821 4992 601 584 0 2667 290 445 256 11772 
1.o. Cattle  536 944 2909 489 0 294 1296 2109 1174 0 4410 45 455 727 6306 
1.p.
 Prosimia
ns 0 0 99 0 0 0 578 0 0 0 0 0 0 0 0 
1.q. N W 0 0 408 0 0 1 433 0 17 0 50 0 0 12 643 
 
EN 16   EN Monkeys  
1.r. O W 
Monkeys 56 449 1579 0 1 83 2778 0 395 0 277 0 0 63 2472 
1.s. Apes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
1.t. Other 
Mammals  0 59 115 185 0 60 0 48 68 0 13 1 972 639 2541 
1.u. Quail 14 425 2457 0 0 1 4023 0 0 0 152 0 0 0 140 
1.v. Other 
birds 1011 13266 39150 7784 21 8424 102240 2024 31697 0 111081 112 5773 7838 114860 4
1.w. Reptiles  40 144 136 54 0 10 0 0 378 0 7 0 0 0 84 
1.x.
 Amphibia
ns 865 6177 10432 840 975 419 15675 0 4636 0 3231 51 20 5496 10585 
1.y. Fish 1199 33965 64337 35958 901300 30584 50397 6420 14584 0 14838 4748 93220 183049 192504 1 6
1.z. TOTAL 167312 718976 1822424 365940 926092 595597 2325398 37940 896966 4120531199 41621 256826 505681 1874207 11 0
(*) France reporting for 2004 
 
EN 17   EN Table 1.1 Tris: Total number of an imals used for experimental purposes in the 10 New EU Member States  
Reporting for 2005 
Species CY CZ EE HU LV LT MT PO SI SK Totals 
1.a. Mice (Mus musculus) 967 82252 4350 138312 10480 5116 0 126492 8556 14975 391500
1.b. Rats (Rattus 
norvegicus) 0 31703 484 109479 2376 493 0 51558 2732 6761 205586
1.c. Guinea-Pigs (Cavia 
porcellus) 0 4075 0 8360 297 0 0 10763 38 594 24127
1.d. Hamsters 
(Mesocricetus ) 0 220 0 137 0 0 0 243 0 0 600
1.e. Other Rodents (other 
Rode 5798 0 381 0 0 0 10826 18 0 17023
1.f. Rabbits (Oryctolagus 
cuniculus) 0 5567 66 9152 166 158 0 3101 533 782 19525
1.g. Cats (Felis catus) 0 29 0 124 0 0 0 121 0 0 274
1.h. Dogs (Canis familiaris) 0 264 0 1206 0 0 0 618 15 6 2109
1.i. Ferrets (Mustela 
putorius furo) 0 1 5 9 0 00 0  01 9001 7 8
1.j. Other Carnivores (other 
Carnivores) 0 7 0 0 0 0 0 6970 0 0 6977
1.k. Horses, donkeys and 
crossbred 0 314 0 6 0 0 0 681 1 0 1002
1.l. Pigs (Sus) 0 1392 0 882 0 0 0 7358 16 0 9648
1.m.  Goats (Capra) 0 56 0 2 0 0 0 130 0 0 188
1.n. Sheep (Ovis) 0 720 0 381 0 0 0 2023 57 0 3181
1.o. Cattle (Bos) 0 711 0 32 0 0 0 13834 0 0 14577
1.p. Prosimians (Prosimia) 0 0 0 0 0 0 0 0 0 0 0
1.q. New World Monkeys 
(Ceboidea) 00 00 0 0  00 0 0 0
1.r. Old World Monkeys 0 51 0 6 0 0 0 0 0 0 57
 
EN 18   EN (Cercopithecoidea) 
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0 0 0 0 0
1.t. Other Mammals (other 
Mammalia) 0 188 0 0 0 0 0 5061 0 0 5249
1.u. Quail (Coturnix 
coturnix) 0 30 0 283 0 0 0 1470 0 251 2034
1.v. Other birds (other Aves) 0 126211 0 17151 0 0 0 61148 22 0 204532
1.w. Reptiles (Reptilia) 0 1475 0 25 0 0 0 121 3 0 1624
1.x. Amphibians (Amphibia) 0 293 0 1709 0 0 0 13216 0 0 15218
1.y. Fish (Pisces) 0 69418 0 9581 0 0 0 43076 0 0 122075
1.z. TOTAL 967 330933 4900 297209 13319 5767 0 358829 11991 23369 1047284
 
EN 19   EN Table 1.2: Classes of animals used for experimental purposes in the EU Member States 
Data of 2005 (*) 
 Species AT BE CY CZ DE DK EL ES EE FR HU IE IT LV L T
Mice  128634 488125 967 82252 1084358 208375 15340 393217 4350 1510334 138312 17776 534614 10480 5 1
Rats 11920 106483 0 31703 435417 85664 6024 125754 484 424387 109479 7722 279774 2376 4
Guinea-Pigs 3149 39530 0 4075 37761 5046 574 16780 0 79350 8360 4 11533 297 
Golden hamsters + other 
rodents 224 4134 0 6018 15538 6783 40 1202 0 21374 518 0 3840 0 
Rabbits 18439 21159 0 5567 103329 5805 1255 11878 66 93282 9152 379 9916 166 1
Cold-blooded animals(1) 2104 40286 0 71186 74905 36852 902275 31013 0 66072 11315 6420 19598 0 
birds (2) 1025 13691 0 126241 41607 7784 21 8425 0 106263 17434 2024 31697 0 
Artio+Perissodactyla (3) 1664 3530 0 3193 20622 8603 548 0 0 13540 1303 3281 4420 0 
Carnivores (4) 97 1530 0 459 6686 843 14 1090 0 7007 1330 286 1094 0 
Prosimians+monk3115+eys+ 
apes 56 449 0 51 2086 0 1 84 0 3789 6 0 412 0 
Other Mammals 0 59 0 188 115 185 0 60 0 0 0 48 68 0 
Total 167312 718976 967 330933 1822424 365940 926094 595597 4900 2325398 297209 37940 896966 13319 5 7
                
Species% total  AT BE CY CZ DE DK EL ES EE FR HU IE IT LV L
Mice  76,88 67,89 100 24,85 59,50 56,94 1,66 66,02 88,78 64,95 46,54 46,85 59,60 78,68 8 8
Rats 7,12 14,81 0,00 9,58 23,89 23,41 0,65 21,11 9,88 18,25 36,84 20,35 31,19 17,84 8
Guinea-Pigs  1,88 5,50 0,00 1,23 2,07 1,38 0,06 2,82 0,00 3,41 2,81 0,01 1,29 2,23 0
Golden hamsters + other 
rodents 0,13 0,57 0,00 1,82 0,85 1, 85 0,00 0,20 0,00 0,92 0, 17 0,00 0,43 0,00 0
Rabbits 11,02 2,94 0,00 1,68 5,67 1,59 0,14 1,99 1,35 4,01 3,08 1,00 1,11 1,25 2
Cold-blooded animals(1) 1,26 5, 60 0,00 21,51 4,11 10,07 97,43 5,21 0, 00 2,84 3,81 16,92 2,18 0,00 0
birds (2) 0,61 1,90 0,00 38,15 2,28 2,13 0, 00 1,41 0,00 4,57 5,87 5,33 3,53 0,00 0
Artio+Perissodactyla (3) 0,99 0,49 0,00 0,96 1,13 2,35 0,06 1,02 0,00 0,58 0, 44 8,65 0,49 0,00 0
Carnivores (4) 0,06 0,21 0,00 0,14 0,37 0,23 0,00 0,18 0,00 0,30 0,45 0,75 0,12 0,00 0
Prosimians+monkeys+ 
apes 0,03 0,06 0,00 0,02 0,11 0, 00 0,00 0,01 0,00 0,16 0, 00 0,00 0,05 0,00 0
 
EN 20   EN  Other Mammals  0,00 0,01 0,00 0,06 0,01 0, 05 0,00 0,01 0,00 0,00 0, 00 0,13 0,01 0,00 0
Total 100 100 100 100 100 100 100 100 100 100 100 100 100 100 1
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 
 
EN 21   ENIII.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 th e origin of some selected species used for 
experimental purposes in the 25 Member States ar e 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 per centage of origin of anim als versus the species.  
0%20%40%60%80%100%
Mice 
 Rats 
Guinea-Pigs 
Hamsters
Rabbits 
Cats 
Dogs 
Ferrets 
Prosimians 
New World Monkeys
Old World Monkeys
Apes 
Quail Figure 1.2:  Origin of species 
Other countries
ETS 123 countries
EU countries
The chart shows that the majo rity of the species originat ed 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 22   ENwere 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 ha s increased in comparison to the report of 
2002. 
 
EN 23   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) 6430346 5408519 842034 38621 141172 254 
1.b. Rats (Rattus norvegicus) 2336032 2002798 294875 17328 21031 118 
1.c. Guinea-Pigs (Cavia 
porcellus) 257307 178363 69291 3245 6408 2 
1.d. Hamsters (Mesocricetus ) 31535 25276 4448 641 1170 0 
1.f. Rabbits (Oryctolagus 
cuniculus) 312681 294616 15595 839 1631 13488 
1.g. Cats (Felis catus) 3898 2251 492 34 1121 1007 
1.h. Dogs (Canis familiaris) 24119 15542 2732 220 5625 3763 
1.i. Ferrets (Mustela putorius 
furo) 2690 1662 240 50 738 22 
1.p. Prosimians (Prosimia) 677 578 99 0 0 111 
1.q. New World Monkeys 
(Ceboidea) 1564 1244 195 65 60 410 
1.r. Old World Monkeys 
(Cercopithecoidea) 8210 1459 719 38 5994 1740 
1.s. Apes (Hominoidea) 0 0 0 0 0 0 
 
EN 24   EN 1.u. Quail (Coturnix coturnix) 9246 8860 0 152 234 0 
1.z. TOTAL 9418305 7941168 1230720 61233 185184   
Note 1 Column 1.5 concerns only those Member c ountries of the Council of  Europe which, at the 
beginning of the reporting period, are Parties to the Convention ET S 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 shoul d be excluded from the total in the column 1.2.  
 
EN 25   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 experime nts of the 25 Member States are presented in 
Table 2.1 at the end of this chapter. 
III.3.2. Treatment and inte rpretation of the data  
Table 2.2 presents the results of th e consolidated data of  the purposes of the procedures carried out 
in the 25 Member States in 2005. In order to facil itate the presentation of results some species and 
some purposes were grouped. 
The percentage of the number of animals used fo r selected purposes is presented in Figure 2.1.  
Figure 2.1 
Purposes of experiments
Research and develop 
human +veterin+dentist 
31%Fundamental biology 
studies 33%Diagnosis of disease 2%Other 8%Education and training 
1,6%
Production and quality 
control human medicine 
and dentistry  11,8%Production and quality 
control veterinary 
medicine 3.5%Toxicological and other 
safety evaluation 8%
 
As in previous years, more than 60% of animals were used in research and development for human 
medicine, veterinary medicine, dentistr y 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 th e total number of animals reported in 2005. 
Toxicological and other safety ev aluation represents 8% of the to tal 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 ai ming to detect changes in trends rather than 
drawing formal conclusions. The most significant change that can be iden tified is the number of 
animals used for toxicological and other safety  evaluation, which has dropped from about 9,9% 
 
EN 26   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 tr aining 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 pr oduction 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 
Species 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)  
Toxicolo
gical and 
other 
safety 
evaluatio
ns 
(includin
g safety 
evaluatio
n of 
products
) Diagn
osis of diseas
e  
Educati
on and 
training Other Total 
Mice  246547
4 272725
4384741 22552
486597 5513
566440946
Rats  677533 116151
7350275 13564 50048 7287
62325813
Other rodents 53241 230403 56006 4512 2606 6548 353316
Rabbits 15463 237411 38761 8322 3856 8829 312642
Carnivores 11605 9309 14884 348 674 2339 39159
Artio+perissodactyla 64419 41079 4542 4100 9491 1634
1139972
Prosimians+monkeys+
apes 1456 1397 7004 16 42 536 10451
Other mammals  8978 214 15 0 4 739 9950
 
EN 27   EN Birds 251443 249024 53935 9723 5440 8949
4659059
Cold-blooded animals 485858 942973 116123 5905 40236 2351
801826275
TOTAL 403547
0 560058
11026286 27201
4198994 9842
381211758
3
Figure 2.2 presents the number of animals used fo r selected purposes by classes of species.  
From Figure 2.2 one can see that the highest amount of use of mi ce and rats is attributed to 
fundamental biology and also of research, devel opment and control of products and devices for 
medicine, dentistry and veterinary  medicine. The use of cold-bloode d animals is following a similar 
pattern for different purposes. 
 
EN 28   EN  Mice (Mus musculus)
 Rats (Rattus norvegicus)
Other rodents
Rabbits (Oryctolagus cuniculus)
Carnivors
Artio+perissodactyla
Prosimians+monkeys+apes
Other Mammals 
Birds
Cold-blooded animals   Biological studies of a fundamental natureResearch,development and quality control of products and
devices for  human medicine and dentistry and for veterinary
medicine) Toxicological and other safety evaluations (including safety
evaluation of products)                   Diagnosis of disease Education and trainingOther
050000010000001500000200000025000003000000Figure 2.2
Species and experimental purposes
 
 
EN 29   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 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) 2.4.Produc
tion and 
quality 
control of 
products 
and 
devices for 
human 
medicine 
and 
dentistry 2.5.Producti
on and 
quality 
control of 
products 
and devices 
for 
veterinary 
medicine 2.6.Toxicolo
gical and 
other safety 
evaluations 
(including 
safety 
evaluation 
of products 
and devices 
for human 
medicine 
and 
dentistry 
and for 
veterinary 
medicine 2.7.Dia
gnosis 
of 
diseas
e 2.8.Educ
ation 
and 
training 2.9.Oth
er 2.10.To
tal 
1.a. Mice (Mus musculus) 246547
41639698 902318 185238 384741 22552
486597 551356 644094
6 
1.b. Rats (Rattus norvegicus) 677533 920875 209791 30851 350275 13564 50048 72876 232581
3 
1.c. Guinea-Pigs (Cavia porcellus) 12911 47490 111505 24323 53498 2150 1691 3739 257307 
1.d. Hamsters (Mesocricetus ) 10716 6167 274 10098 1670 1395 390 825 31535 
1.e. Other Rodents (other 
Rodentia) 29614 30359 0 187 838 967 525 1984 64474 
1.f. Rabbits (Oryctolagus 
cuniculus) 15463 32814 185572 19025 38761 8322 3856 8829 312642 
1.g. Cats (Felis catus) 1123 1044 138 687 222 64 129 491 3898 
1.h. Dogs (Canis familiaris) 1997 4457 244 1182 14621 243 500 616 23860 
1.i. Ferrets (Mustela putorius furo) 510 1299 42 14 41 41 45 698 2690 
1.j. Other Carnivores (other 7975 0 0 202 0 0 0 534 8711 
 
EN 30   EN Carnivore) 
1.k. Horses, donkeys and cross 
breds (Equidae) 1293 472 203 1957 40 182 973 192 5312 
1.l. Pigs (Sus) 27052 15159 489 6610 3349 1888 5854 5821 66222 
1.m.  Goats (Capra) 828 280 84 41 39 214 317 343 2146 
1.n. Sheep (Ovis) 10442 2721 5731 1217 457 871 956 7626 30021 
1.o. Cattle (Bos) 24804 3691 55 2369 657 945 1391 2359 36271 
1.p. Prosimians (Prosimia) 384 0 0 0 97 0 0 196 677 
1.q. New World Monkeys 
(Ceboidea) 357 327 43 0 650 16 5 166 1564 
1.r. Old World Monkeys 
(Cercopithecoidea) 715 654 373 0 6257 0 37 174 8210 
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0 0 0 
1.t. Other Mammals (other 
Mammalia) 8978 144 0 70 15 0 4 739 9950 
1.u. Quail (Coturnix coturnix) 1722 0 0 0 3191 0 169 3913 8995 
1.v. Other birds (other Aves) 249721 104833 12727 131464 50744 9723 5271 85581 650064 
1.w. Reptiles (Reptilia) 1646 13 0 0 12 0 774 32 2477 
1.x. Amphibians (Amphibia) 55349 253 0 0 542 99 15666 2711 74620 
1.y. Fish (Pisces) 428863 933278 280 9149 115569 5806 23796 232437 174917
8 
1.z. TOTAL 403547
03746028 1429869 424684 1026286 27201
4198994 984238 121175
83 
(*)France reporting for 2004 
 
EN 31   ENIII.4. Results of EU Table 3: Toxicological and safety evaluation by type of 
product/endpoints  
III.4.1. The data on toxicologica l and safety evaluation by type of products/endpoints 
The consolidated table giving the number of an imals used in toxicological and other safety 
evaluation of products (EU Table 3) in 25 Memb er States is presented in Table 3.1 at the 
end of this chapter. 
The percentage of the number of animals used fo r 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
3.3     Products/ substances 
used or intended to be used 
mainly in agriculture
9,5%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%3.6    Products/ substances 
used or intended to be used 
mainly as cosmetics or  
toiletries
0,5%3.7    Products/ substances 
used or intended to be used 
mainly as additives in food 
for human consumption
0,4%3.8    Products/ substances 
used or intended to be used 
mainly as additives in food 
for animal consumption
3,3%3.9   Potential  or actual 
contaminents in the general 
environment which do not 
appear in other columns
8,3%
3.2    Products/ substances 
or devices for human 
medicine and dentistry and 
for veterinary medicine
50,9%3.10    Other  toxicological or 
safety evaluations
17,6%
 
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 us ed for experimental purposes is used for 
toxicological and other safety evaluation. Th is accounts for 1,026,286 animals (see III.3.3)  
The percentage of animals used for t oxicological evaluation of 4 groups of 
products/substances, i.e., animal feed, addi tives 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, ve terinary medicine and dentistry represents 
50,9% of the animal used for toxicol ogical or other safety evaluations. 
 
EN 32   ENThe group of products/substances falling under th e 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 f ood 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 num ber 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 wo rth noting in light of 
the legal requirement to phase out animal tes ting 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 toxi cological or safety ev aluation (ranging from 
around 110,000 to 180,000). This category could benefit from further analysis. Member States reported that it concer ned new methods and tests, such  as: tests on transmission of 
microcystins on embryonic membrane; bioassays ; toxicity evaluati on for humans via the 
environment; and control of safety for toys. 
 
EN 33   EN Table 3.1: Number of animals used in toxicological and other safety evaluation 
Products versus species 
Data of 2005* 
3.1.Species 3.2. 
Products/ 
substances 
or devices 
for human 
medicine 
and dentistry 
and for 
veterinary 
medicine 3.3. 
Produc
ts/ 
substa
nces 
used or 
intende
d to be 
used 
mainly 
in 
agricult
ure 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 
toiletries3.7.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 3.9.Poten
tialor 
actual 
contamin
ants in 
the 
general 
environm
ent which 
do not 
appear in 
other 
columns 3.10.Other 
toxicological 
or safety 
evaluations 3.11.To
tal 
1.a. Mice (Mus musculus) 210 840 18 546 26 677 72 1 797 1 268 1 630 9 264 116 850 386 
944 
1.b. Rats (Rattus norvegicus) 210 719 41 903 44 768 294 2 226 2 644 704 8 883 36 707 348 
648 
1.c. Guinea-Pigs (Cavia 
porcellus) 35 123 3 051 7 128 177 940 46 0 156 6 877 53 498 
1.d. Hamsters (Mesocricetus 
) 1 065 571 18 0 0 0 0 0 16 1 670 
1.e. Other Rodents (other 
Rodentia) 300 68 28 0 0 0 0 442 0 838 
1.f. Rabbits (Oryctolagus 
cuniculus) 26 030 3 593 4 433 116 608 141 113 25 4 094 39 153 
1.g. C a t s  ( F e l i s  c a t u s )  2 2 2 000000 0 0  222 
1.h. Dogs (Canis familiaris) 12 671 509 278 0 0 0 0 29 1 118 14 605 
1.i. Ferrets (Mustela putorius 
furo) 4 1 000000 0 0  4 1  
 
EN 34   EN 1.j. Other Carnivores (other 
Carnivore) 0 000000 0 0  0  
1.k. Horses, donkeys and 
cross breds (Equidae) 3 5 500000 0 0  4 0  
1.l. Pigs (Sus) 2 246 90 47 0 0 76 444 103 241 3 247 
1.m.  G o a t s  ( C a p r a )  2 4 500000 1 0 0  3 9  
1.n. Sheep (Ovis) 351 1 00000 1 0 7 2 1 4  457 
1.o. C a t t l e  ( B o s )  4 8 9 4 80000 1 0 5 0 1 5  657 
1.p. P r o s i m i a n s  ( P r o s i m i a )  9 7 000000 0 0  9 7  
1.q. New World Monkeys 
(Ceboidea) 6 1 3 000000 0 3 7  650 
1.r. Old World Monkeys 
(Cercopithecoidea) 5  0 5 7 060000 0 1  1 9 4  6  257 
1.s. Apes (Hominoidea) 0 000000 0 0  0  
1.t. Other Mammals (other 
Mammalia) 1 5 000000 0 0  1 5  
1.u. Q u a i l  ( C o t u r n i x  c o t u r n i x )  0 3  1 6 100000 2 5 0  3  186 
1.v. Other birds (other Aves) 9 246 3 728 98 0 0 0 31 119 1 437 5 116 50 744 
1.w. R e p t i l e s  ( R e p t i l i a )  0 000000 0 1 2  1 2  
1.x. A m p h i b i a n s  ( A m p h i b i a )  0 4 0 00000 1 0 0 0 4 2  542 
1.y. Fish (Pisces) 6 937 21 944 12 998 560 0 0 0 64 286 7 799 114 
524 
1.z. TOTAL 522 121 97 632 96 479 1 219 5 571 4 175 34 225 84 732 180 132 1 026 
286 
(*) France reporting for 2004 
 
EN 35   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 us ed 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 pe r 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 animal s 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%
Human cancer (excl. 
evaluation of carcino 
hazards)
12,8%Human nervous and 
mental disorder
21,6%
Other human 
diseases
40,5%Specific animal 
diseases
19%
 
In 2005, the proportion and the number of animals used  (ranging from 900,000 to 
1,329,000) for the studies of animal diseases ha ve increased significan tly 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, f oot and mouth disease, 
swine fever and more recently avian flew. An imals used also covers studies on genetic 
diseases.  
An important part, around 60%, of the increa se of the total use of mice (579,000) in 
comparison with 2002, can be attributed to different studies of diseases. 
 
EN 36   EN Table 4.1: Number of animals used in experim ents 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 4.4 Human 
cancer 
(excluding 
evaluations of 
carcinogenic 
hazards or 
risks) 4.5 Other 
human 
diseases 4.6 Studies 
specific to 
animal 
diseases 4.7 Total 
1.a. Mice (Mus musculus) 233054 843362 801787 1862317 158718 3899238
1.b. Rats (Rattus norvegicus) 154838 610191 80825 642300 5251 1493405
1.c. Guinea-Pigs (Cavia 
porcellus) 4721 7581 781 57019 5200 75302
1.d. Hamsters (Mesocricetus ) 2121 4471 579 7302 2931 17404
1.e. Other Rodents (other 
Rodentia) 84 24311 487 12750 3038 40670
1.f. Rabbits (Oryctolagus 
cuniculus) 11601 3769 631 23941 7864 47806
1.g. Cats (Felis catus) 13 203 52 339 992 1599
1.h. Dogs (Canis familiaris) 1538 367 347 6001 2395 10648
1.i. Ferrets (Mustela putorius 
furo) 228 159 33 1693 71 2184
1.j. Other Carnivores (other 
Carnivore) 2 0 0 500 540 1042
1.k. Horses, donkeys and cross 
breds (Equidae) 8 29 8 110 919 1074
1.l. Pigs (Sus) 4902 943 198 8548 11226 25817
1.m.  Goats (Capra) 184 25 3 481 205 898
1.n. Sheep (Ovis) 759 523 52 7138 7953 16425
 
EN 37   EN 1.o. Cattle (Bos) 140 1841 0 2608 7727 12316
1.p. Prosimians (Prosimia) 0 383 0 0 0 383
1.q. New World Monkeys 
(Ceboidea) 58 204 2 810 0 1074
1.r. Old World Monkeys 
(Cercopithecoidea) 53 167 179 2882 9 3290
1.s. Apes (Hominoidea) 0 0 0 0 0 0
1.t. Other Mammals (other 
Mammalia) 250 189 3 1777 65 2284
1.u. Quail (Coturnix coturnix) 0 197 0 25 0 222
1.v. Other birds (other Aves) 1443 6282 0 27269 159253 194247
1.w. Reptiles (Reptilia) 13 115 0 24 79 231
1.x. Amphibians (Amphibia) 1067 1338 2923 10297 277 15902
1.y. Fish (Pisces) 300 3898 421 146936 954534 1106089
1.z. TOTAL 417377 1510548 889311 2823067 1329247 6969550
France reporting for 2004 
 
EN 38   EN Table 4.2: Number of animals used in st udies 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  233054 843362 801787 1862317 158718 3899238
Rats  154838 610191 80825 642300 5251 1493405
Guinea-Pigs  4721 7581 781 57019 5200 75302
Other rodents 2205 28782 1066 20052 5969 58074
Rabbits  11601 3769 631 23941 7864 47806
Carnivores 1781 729 432 8533 3998 15473
Artio + Perrisodactyla 5993 3361 261 18885 28030 56530
Prosimians+Monkeys+Apes 111 754 181 3692 9 4747
Other Mammals  250 189 3 1777 65 2284
Birds 1443 6479 0 27294 159253 194469
Cold-blooded animals 1380 5351 3344 157257 954890 1122222
TOTAL 417377 1510548 889311 2823067 1329247 6969550
       
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  5,98 21,63 20,56 47,76 4,07 100,00
Rats  10,37 40,86 5,41 43,01 0,35 100,00
Guinea-Pigs  6,27 10,07 1,04 75,72 6,91 100,00
Other rodents 3,80 49,56 1,84 34,53 10,28 100,00
Rabbits  24,27 7,88 1,32 50,08 16,45 100,00
 
EN 39   EN Carnivores 11,51 4,71 2,79 55,15 25,84 100,00
Artio + Perrisodactyla 10,60 5,95 0,46 33,41 49,58 100,00
Prosimians+Monkeys+Apes 2, 34 15,88 3,81 77,78 0,19 100,00
Other Mammals  10,95 8, 27 0,13 77,80 2,85 100,00
Birds 0,74 3,33 0,00 14,04 81,89 100,00
Cold-blooded animals 0,12 0,48 0,30 14,01 85,09 100,00
TOTAL 5,99 21,67 12,76 40,51 19,07 100,00
 
EN 40   ENSpecies of Table 4.1 were grouped into classes of animals to present Table 4.2. The 
relative percentage of animals pe r classes of species used in st udies by type of diseases has 
been calculated and is also presen ted 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.  
0%20%40%60%80%100%
Mice 
Rats 
Guinea-Pigs 
Other rodents
Rabbits 
Carnivors
Artio + Perrisodactyla
Prosimians+Monkeys+Apes
Other Mammals 
Birds
Cold-blooded animalsFigure 4.2
Proportion of animals used by classes per type of studies of 
diseases
Specific animals diseases  %
Other human diseases %
Human cancer (excl. evaluation of
carcino hazards) %
Human nervous and mental disorder%
Human Cardiovascular diseases%
 
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. Howeve r, in some Member States only birds are 
used if the infection concerns bird species. 
In 2005, the proportion of other mammals used fo r specific animal diseases has decreased 
but increased proportionally in st udies of other human diseases.  
Overall the general pattern of the proportion of  animals used for the studies of diseases 
presented very little change when compar ed to the previous statistical report.  
 
EN 41   ENIII.6. Results of EU Table 5: Animals used in production and quality control of 
products for human medicine and de ntistry and for veterinary medicine  
III.6.1. The data on animals used in produc tion and quality contro l 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 veteri nary medicine (EU Table 5) is presented in 
Table 5.1 of this report. 
III.6.2. Treatment and inte rpretation 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 veterina ry medicine represents  15,3% of the total 
number of animals used for experimental pur poses. Figure 5.1 gives th e 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
2,56
33,31
0,01
2,10
5,1656,850,00 10,00 20,00 30,00 40,00 50,00 60,00
5.2     National legislation
specific to a single EC Member
State
5.3     EC legislation including
European Pharmacopoeia
(requirements)
5.4     Member Country of
Council of Europe (but not EC)
legislation
5.5    Other legislation
5.6      Any combination of 5.2/
5.3/ 5.4/ 5.5
 5.7       No regulatory
requirements2005
 
The largest proportion of animals in this area  (57%) was used to si multaneously 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 th e 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 le gislation in comparis on 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 42   EN Table 5.1: Number of animals used in th e production and quality control of products and devices for human medicine and dentistr y 
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) 5.4. 
Member 
Country of 
Council of 
Europe (but 
not EC) 
legislation2)5.5. Other 
legislation5.6. Any 
combination 
of 5.2/ 5.3/ 
5.4/ 5.5 5.7. No 
regulatory 
requirements5.8. Total 
1.a. Mice (Mus musculus) 24912 326864 20 13463 685435 36912 1087606 
1.b. Rats (Rattus norvegicus) 5551 82479 0 18436 127504 6822 240792 
1.c. Guinea-Pigs (Cavia porcellus) 8558 44713 7 6041 73163 3346 135828 
1.d. Hamsters (Mesocricetus ) 0 4528 0 0 5449 395 10372 
1.e. Other Rodents (other Rodentia) 0 0 0 0 187 0 187 
1.f. Rabbits (Oryctolagus cuniculus) 2566 85556 0 308 87867 28300 204597 
1.g. Cats (Felis catus) 76 607 0 13 111 18 825 
1.h. Dogs (Canis familiaris) 21 1016 0 0 241 148 1426 
1.i. Ferrets (Mustela putorius furo) 14 30 0 0 6 6 56 
1.j. Other Carnivores (other Carnivore) 0 202 0 0 0 0 202 
1.k. Horses, donkeys and cross breds 
(Equidae) 229 219 0 2 281 1429 2160 
1.l. Pigs (Sus) 136 4363 0 9 1572 1019 7099 
1.m.  Goats (Capra) 0 4 0 0 118 3 125 
1.n. Sheep (Ovis) 176 838 0 0 3650 2284 6948 
1.o. Cattle (Bos) 125 1462 26 10 533 268 2424 
1.p. Prosimians (Prosimia) 0 0 0 0 0 0 0 
1.q. New World Monkeys (Ceboidea) 0 35 0 0 0 8 43 
1.r. Old World Monkeys 
(Cercopithecoidea) 0 6 0 0 357 10 373 
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0 
1.t. Other Mammals (other Mammalia) 10 60 0 0 0 0 70 
 
EN 43   EN 1.u. Quail (Coturnix coturnix) 0 0 0 0 0 0 0 
1.v. Other birds (other Aves) 3913 61303 152 683 63959 14181 144191 
1.w. Reptiles (Reptilia) 0 0 0 0 0 0 0 
1.x. Amphibians (Amphibia) 0 0 0 0 0 0 0 
1.y. Fish (Pisces) 1222 3446 0 0 3971 590 9229 
1.z. TOTAL 47509 617731 205 38965 1054404 95739 1854553 
(*) France reporting for 2004 
Exampl
es: 5.2 - France is testing due to a UK (or FR) 
specific requirement  Note:  columns 5.2 - 5.5 refer to the legislation imposing that the 
test be carried out  
 5.3 - UK is testing according to EC legislation   and not to the body which ha s issued the actual test 
method, guideline or protocol  
 5.4 - Spain is testing due to a Hungarian 
requirement  Example:  a test required by French legislation and carried out in 
Belgium according to an  
 5.5 - Sweden is testing due to a US specific 
requirement   ISO protocol must be coded as a national (FR) legislative 
requirement and be  
 5.6 - Germany is testing due to a Czech 
requirement (also an EC requirement)   entered into column 5.2 in the tables submitted by 
Belgium.  
 
EN 44   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 regulato ry requirements fo r animals used in 
toxicological and othe r 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 animal s 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 Figur e 5.1 in the previous chapter. 
As pointed out earlier, the num ber 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 regu latory requirements for toxicological 
and other safety evaluation  
23,65
0,12
3,93
54,209,39
8,710,00 10,00 20,00 30,00 40,00 50,00 60,00
6.2     National legislation
specific to a single EC Member
State
6.3     EC legislation including
European Pharmacopoeia
(requirements)
6.4     Member Country of
Council of Europe (but not EC)
legislation
6.5    Other legislation
6.6      Any combination of 6.2/
6.3/ 6.4/ 6.5
 6.7       No regulatory
requirements
 
Animals used to simultaneously satisfy regul atory requirements from  several pieces of 
legislation covered more than ha lf 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 45   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 th e 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 re gulatory requirements co mpared to previous 
reports, indicated that the decrease was partiall y attributed to use of alternative in vitro 
methods and invertebrate animals. For exampl e, 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 regu latory 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 repor t with respect to the previous one but it represents about 15,500 
animals i.e. 1,5% of the total number used fo r toxicological and other safety evaluation. 
 
EN 46   EN Table 6.1: Number of animals used in toxicological and other safety evaluations 
Regulatory requirements versus species 
Data of 2005* 
6.1. Species 6.2. National 
legislation 
specific to a 
single EC 
Member 
State1) 6.3. EC 
legislation 
including 
European 
Pharmacopoeia 
(requirements) 6.4. Member 
Country of 
Council of 
Europe (but 
not EC) 
legislation2) 6.5. Other 
legislation6.6. Any 
combination 
of 5.2/ 5.3/ 
5.4/ 5.5 6.7. No 
regulatory 
requirements6.8.Total 
1.a. Mice (Mus musculus) 39972 104143 170 15039 189776 37144 386244 
1.b. Rats (Rattus norvegicus) 19368 61953 670 15875 224860 25772 348498 
1.c. Guinea-Pigs (Cavia 
porcellus) 1009 21189 70 2052 27849 1329 53498 
1.d. Hamsters (Mesocricetus ) 0 182 0 0 1204 284 1670 
1.e. Other Rodents (other 
Rodentia) 0 300 0 0 0 583 883 
1.f. Rabbits (Oryctolagus 
cuniculus) 1398 9462 13 2653 23162 2420 39108 
1.g. Cats (Felis catus) 166 46 0 6 4 23 245 
1.h. Dogs (Canis familiaris) 977 1919 0 520 10842 324 14582 
1.i. Ferrets (Mustela putorius 
furo) 00 0  0 4 1 0 4 1  
1.j. Other Carnivores (other 
Carnivore) 00 0  0 0 0 0  
1.k. Horses, donkeys and cross 
breds (Equidae) 0 5 0 0 25 10 40 
1.l. Pigs (Sus) 57 1150 0 132 1642 266 3247 
1.m.  Goats (Capra) 0 26 0 0 3 44 73 
1.n. Sheep (Ovis) 4 120 0 0 191 108 423 
1.o. Cattle (Bos) 12 320 0 15 203 107 657 
1.p. Prosimians (Prosimia) 0 97 0 0 0 0 97 
1.q. New World Monkeys 0 0 0 0 599 51 638 
 
EN 47   EN (Ceboidea) 
1.r. Old World Monkeys 
(Cercopithecoidea) 0 304 0 488 5312 153 6257 
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0 
1.t. Other Mammals (other 
Mammalia) 01 5 0  0 0 0 1 5  
1.u. Quail (Coturnix coturnix) 0 2124 0 0 1037 25 3186 
1.v. Other birds (other Aves) 5519 4787 0 522 38262 1654 50744 
1.w. Reptiles (Reptilia) 12 0 0 0 0 0 12 
1.x. Amphibians (Amphibia) 542 0 0 0 0 0 542 
1.y. Fish (Pisces) 27338 34565 312 3029 31210 19120 115574 
1.z. TOTAL 96374 242707 1235 40331 556222 89417 1026286 
(*)France reporting for 2004 
Example
s: 6.2 - France is testing due to a UK (or FR) specific 
requirement  Note:  
 6.3 - UK is testing according to EC legislation   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  
 6.4 - Spain is testing due to a Hungarian requirement  Exam
ple: a test required by French legislation and carried out in 
Belgium according to an  
 6.5 - Sweden is testing due to a US specific requirement   ISO protocol must be coded as a national (FR) 
legislative requirement and be  
 6.6 - Germany is testing due to  a Czech requirement (also 
an EC requirement)   entered into column 6.2 in the tables submitted by 
Belgium.  
 
EN 48   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 ot her safety evaluations 
The consolidated table for the 25 Member States re porting on animals used in toxicity tests for the 
purpose of toxicological and other sa fety 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 so me 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 to xicity 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
5,88
10,90
10,11
1,24
22,327,5542,010,00 10,00 20,00 30,00 40,00 50,00
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
 
As pointed out in th e previous chapter, the number of animals used in toxicologica l and other safety 
evaluation represents 8% of the total number of animals used for experimental purposes. 
 
EN 49   EN It can be seen in Figure 7.1 that the largest percen tage 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, mutagenic ity 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', Memb er States reported test ing in areas such as 
biological screening for pharmaceutical, healthcar e and veterinary products. This includes 
neurotoxicity, toxicokinetics, test ing of acute dermal toxicity, te sting of biological evaluation of 
medical devices: Intracutan testing of reactivity on rabbits, study into penetration of nanoparticle 
through tissue and their biocompatibility, study in to evaluation of sensi tization potential of 
dyestuffs used in textile industry and pharmaco logical studies include d in safety tests. 
By looking both in numbers and relative percenta ges 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 ra nging from: 32%, 36% to 42% resp ectively. This represents in 
animal numbers an increase of 39,000 animals si nce the last report of 2002. Member States 
attributed the increase in  part to several phases in new produc t 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 repor ts 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 anim als 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 repla cement methods have a much greater impact on R&D 
than on regulatory requirements. Th ey point out that the statistics drawn up annually include re-use 
of animals which plays an important role.  
 
EN 50   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 7.4. 
Skin 
sensi
tisati
on 7.5. 
Eye 
irritati
on 7.6. 
Sub- 
chroni
c and 
chroni
c 
toxicity7.7. 
Carci
no- 
genic
ity 7.8. 
Devel
op- 
mental 
toxicity7.9. 
Muta- 
genic
ity 7.10. 
Repr
o-
ducti
ve 
toxicit
y 7.11. 
Toxicity 
to 
aquatic 
vertebr
a-tes 
not 
include
d in 
other 
column
s 7.12. 
Other 7.13. 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2. 
Other 
lethal 
metho
ds 7.2.3. 
Non 
lethal 
clinical 
signs 
method
s                       
1.a. Mice (Mus musculus) 33024 86669 68682 2805 2135
00 25550 1962
42612 1947
9908 0 1055
41 38624
4 
1.b. Rats (Rattus norvegicus) 19756 18614 78707 1156 303 142 65466 2240
023886 1572
75151
80 5082
9 34850
4 
1.c. Guinea-Pigs (Cavia 
porcellus) 1415 993 17572 2144 2218
40 628 0 0 0 0 0 8556 53492 
1.d. Hamsters (Mesocricetus ) 0 64 603 0 0 0 38 0 0 20 0 0 945 1670 
1.e. Other Rodents (other 
Rodentia) 56 142 300 0 0 0 300 0 0 0 0 0 40 838 
1.f. Rabbits (Oryctolagus 
cuniculus) 36 49 2944 5130 52 4033 1693 0 8078 31 4640 0 1246
7 39153 
1.g. Cats (Felis catus) 0 0 108 0 0 0 0 0 0 0 0 0 114 222 
 
EN 51   EN 1.h. Dogs (Canis familiaris) 182 659 5170 0 0 0 6998 0 0 0 29 0 1567 14605 
1.i. Ferrets (Mustela putorius 
furo) 0  0 4 1000 00 000 00  4 1  
1.j. Other Carnivores (other 
Carnivore) 0  0 0000 00 000 00  0  
1.k. Horses, donkeys and 
cross breds (Equidae) 0  0 1 0000 00 000 0 3 0  4 0  
1.l. Pigs (Sus) 8 49 304 8 0 0 971 0 89 0 100 0 1718 3247 
1.m.  Goats (Capra) 0 0 0 0 0 0 0 0 0 0 0 0 39 39 
1.n. Sheep (Ovis) 0 0 32 0 0 0 0 0 35 0 37 0 353 457 
1.o. Cattle (Bos) 0 0 73 0 0 0 0 0 0 0 0 0 584 657 
1.p. Prosimians (Prosimia) 0 0 60 0 0 0 32 0 0 0 0 0 5 97 
1.q. New World Monkeys 
(Ceboidea) 0 85 222 0 0 0 185 0 90 0 0 0 68 638 
1.r. Old World Monkeys 
(Cercopithecoidea) 0 1 2014 0 0 33 3406 0 131 0 187 0 485 6257 
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
1.t. Other Mammals (other 
Mammalia) 0 0 0 0 0 0 0 0 0 0 0 0 15 15 
1.u. Quail (Coturnix coturnix) 2253 348 105 0 0 0 0 0 0 0 480 0 0 3186 
1.v. Other birds (other Aves) 1671 260 11403 1000 0 0 158 0 0 0 128 0 3612
4 50744 
1.w. Reptiles (Reptilia) 0 0 0 0 0 0 0 0 0 0 0 0 12 12 
1.x. Amphibians (Amphibia) 0 0 0 0 0 0 0 0 42 0 0 0 500 542 
1.y. Fish (Pisces) 54830 10449 11146 0 0 0 6443 0 5484 226 5284 12675 9037 11557
4 
1.z. TOTAL 11323
1 11838
2199496 1224
34388
94208 11186
84202
440447 3548
36331
112675 2290
29 10262
86 
(*) France reporting for 2004  
 
EN 52   EN Table 7.2: Grouping of certain type of tests on animals of table 7.1  
 
7.1. Species Acute and 
sub-acute 
toxicity testing 
methods 
(including limit 
test) Irritation 
/sensitization 
tests  Sub- 
chronic 
and 
chronic 
toxicity Mutagenicity 
and 
carcinogenicityReproductive 
and 
developmental 
toxicity Toxicity to 
aquatic 
vertebrates 
not 
included in 
other 
columns other Tot
1.a. Mice (Mus musculus) 188375 24155 25550 39103 3520 0 105541 38 6
1.b. Rats (Rattus norvegicus) 117077 1601 65466 38127 75404 0 50829 34 8
1.c. Guinea-Pigs (Cavia 
porcellus) 19980 24328 628 0 0 0 8556 5 3
1.d. Hamsters (Mesocricetus ) 667 0 38 20 0 0 945 1
1.e. Other Rodents (other 
Rodentia) 498 0 300 0 0 0 40 
1.f. Rabbits (Oryctolagus 
cuniculus) 3029 9215 1693 31 12718 0 12467 3 9
1.g. Cats (Felis catus) 108 0 0 0 0 0 114 
1.h. Dogs (Canis familiaris) 6011 0 6998 0 29 0 1567 1 4
1.i. Ferrets (Mustela putorius 
furo) 4 1 00  0 0 00  
1.j. Other Carnivores (other 
Carnivore) 00 0  0 0 0 0  
1.k. Horses, donkeys and cross 
breds (Equidae) 10 0 0 0 0 0 30 
1.l. Pigs (Sus) 361 8 971 0 189 0 1718 3
1.m.  Goats (Capra) 0 0 0 0 0 0 39 
1.n. Sheep (Ovis) 32 0 0 0 72 0 353 
1.o. Cattle (Bos) 73 0 0 0 0 0 584 
1.p. Prosimians (Prosimia) 60 0 32 0 0 0 5 
 
EN 53   EN 1.q. New World Monkeys 
(Ceboidea) 307 0 185 0 90 0 68 
1.r. Old World Monkeys 
(Cercopithecoidea) 2015 33 3406 0 318 0 485 6
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0 
1.t. Other Mammals (other 
Mammalia) 0 0 0 0 0 0 15 
1.u. Quail (Coturnix coturnix) 2706 0 0 0 480 0 0 3
1.v. Other birds (other Aves) 13334 1000 158 0 128 0 36124 5 0
1.w. Reptiles (Reptilia) 0 0 0 0 0 0 12 
1.x. Amphibians (Amphibia) 0 0 0 0 42 0 500 
1.y. Fish (Pisces) 76425 0 6443 226 10768 12675 9037 11 5
1.z. TOTAL 431109 60340 111868 77507 103758 12675 229029 102 6
 
EN 54   ENIII.9. Results of EU Table 8: Type of toxicity tests ca rried out for toxicological 
and other safety evaluations of products  
III.9.1. The data on type of toxicity test s 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 th e 25 Member States reporting (EU Table 8) 
is presented in Table 8.1 of this report.  There are discrepanc ies 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 thes e 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 trea tment 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 percen tages of the number of anim als used in toxicological 
testing or other safety evaluations in rela tion to the type of products or purposes. In 
order to give a better graphica l 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 55   EN0% 20% 40% 60% 80% 100% 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 evaluationsFigure 8
Percenta ges of animals used for toxicit y tests for toxicolo gical and 
other safety evaluation by types of products
  Acute and sub-acute toxicity
testing methods (including limit
test)
Irritation/sensitization tests
Sub- chronic and chronic toxicity
Mutagenicity and carcinogenicity
Reproductive and developmentaltoxicity
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, dent istry 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 toxi cological 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 sensitiz ation 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 te sts with the highest pr oportion used for D) 
household products and F) additives in food for human consumption.  
The pattern of use of carci nogenicity, mutagenicity and to xicity to reproduction tests 
is rather scattered between the different  types of products and more difficult to 
interpret.  
 
EN 56   ENThe proportion of animals used for G) addi tives in food for animal consumption is 
governed by about 90% by other tests. This group would benefit fr om further analysis. 
 
EN 57   EN Table 8.1: Number of animals used in toxicological and other safety evaluations 
Type of tests versus products 
Data of 2005* 
8.1. Products 8.2. Acute and sub-acute 
toxicity testing methods 
(including limit test) 8.3. 
Skin 
irritati
on 8.4. 
Skin 
sensiti
sation8.5. 
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 8.11. 
Toxicity 
to 
aquatic 
vertebr
a-tes 
not 
include
d in 
other 
column
s 8.12. 
Other 8.13. 
Total 
  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  18820 38091 155459 4097 15296 145
267651 2658
91823
82100
53078
83419 1272
84 52818
9 
8.b. Products/ substances used or intended to be used mainly in agriculture 21368 5956 11467 872 6486 654 12535 3100 1015
81831 1259
91847 8687 97560 
8.c. Products/ substances 
used or intended to be used mainly in industry 18963 4047 13416 4743 9264 111
113177 2644 3230 8371 1004
32136 5684 96829 
 
EN 58   EN 8.d. Products/ substances 
used or intended to be used mainly in the household 20 18 11 48 154 70 568 3 0 51 0 0 276 1219 
8.e. Products/ substances 
used or intended to be used mainly as cosmetics or toiletries 0 349 684 469 2222 300 966 0 368 213 0 0 0 5571 
8.f. Products/ substances 
used or intended to be used mainly as additives in food for human consumption 6 40 1283 3 98 3 1767 0 0 239 1210 0 572 5221 
8.g. Products/ substances 
used or intended to be used mainly as additives in food for animal consumption 0 907 239 30 0 0 160 24 0 0 423 0 3169
2 33475 
8.h. Potential or actual 
contaminants in the general environment which do not appear in other columns 32120 9894 5959 0 0 0 3793 7045 4541 594 5393 6524 7885 83748 
8.i. Other toxicological or 
safety evaluations 20974 58282 8840 668 4921 478 23062 1459 2756 4836 2088 4593 4151
7 17447
4 
8.j. TOTAL 112271 11758
4197358 10930 38441 406
8123679 4086
43929
13714
06254
418519 2235
97 10262
86 
(*) France reporting for 2004
 
EN 59   EN Table 8.2: Number of animals used  in toxicological and other safety  evaluation per types of products 
8.1. Products Acute 
and sub-
acute 
toxicity 
testing 
methods 
(including 
limit test) Irritation/sensitization 
tests Sub- 
chronic and chronic toxicity Mutagenicity 
and carcinogenicityReproductive 
and developmental toxicity Toxicity 
to aquatic vertebra-tes not included in other columns Other Total 
8.a. Products/ substances or 
devices for human medicine and dentistry and for veterinary medicine  212370 20845 67651 47594 49026 3419 127284 528189 
8.b. Products/ substances 
used or intended to be used mainly in agriculture 38791 8012 12535 4931 22757 1847 8687 97560 
8.c. Products/ substances 
used or intended to be used mainly in industry 36426 15118 13177 11015 13273 2136 5684 96829 
8.d. Products/ substances 
used or intended to be used mainly in the household 49 272 568 54 0 0 276 1219 
8.e. Products/ substances 
used or intended to be used mainly as cosmetics or toiletries 1033 2991 966 213 368 0 0 5571 
8.f. Products/ substances 
used or intended to be used mainly as additives in food for human consumption 1329 104 1767 239 1210 0 572 5221 
 
EN 60   EN 8.g. Products/ substances 
used or intended to be used mainly as additives in food for animal consumption 1146 30 160 24 423 0 31692 33475 
8.h. Potential or actual 
contaminants in the general environment which do not appear in other columns 47973 0 3793 7639 9934 6524 7885 83748 
8.i. Other toxicological or 
safety evaluations 88096 6067 23062 6295 4844 4593 41517 174474 
8.j. TOTAL 427213 53439 123679 78004 101835 18519 223597 1026286