EN    EN EN 
EN 2   EN  EUROPEAN COMMISSION 
Brussels, 8.12.2010  
SEC(2010) 1107 final/2  VOL A 
  
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Annule et remplace le document SEC(2010) 1107  du 30.9.2010 final Concerne : toutes les versions 
COMMISSION STAFF WORKING DOCUMENT 
 
Accompanying document to the 
REPORT FROM THE COMMISSION TO  THE COUNCIL AND THE EUROPEAN 
PARLIAMENT 
 
Sixth 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(2010) 511 
EN 3   EN TABLE OF CONTENTS 
I. INTRODUCTION ....................................................................................................... 4 
II. DATA SUBMITTED AND GENERAL ASSESSMENT........................................... 5 II.1. Data submitted by the Member States ......................................................................... 5 
II.2. General assessment ...................................................................................................... 5  
II.3. Structure of the Report................................................................................................. 7  
PART A: COMPILATION AND OVERVI EW OF THE DATA OF 2008.............................. 8 
III.1. Results of EU Table 1: Species and number of animals
.............................................. 8 
III.2. Results of EU Table 1: Origin of animals used ......................................................... 15 
III.3. Results of EU Table 2: Purposes of the experiments ................................................. 18 
III.4. Results of EU Table 3: Toxicological and safety evaluation by type of 
product/endpoint ........................................................................................................ 23 
III.5. Results of EU Table 4: Animals used for studies of diseases .................................... 26 
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 ................................ 31 
III.7. Results of EU harmonized Table 6: Origin of regulatory requirements for animals 
used in toxicological and  other safety evaluations .................................................... 34 
III.8. Results of EU Table 7: Animals used in toxicity test s for toxicological and other 
safety evaluations ....................................................................................................... 37 
III.9. Results of EU Table 8: Type of toxicity tests carried  out for toxicological and other 
safety evaluations of products .................................................................................... 41 
EN 4   EN I. INTRODUCTION 
The objective of this report is to present to  the Council and the European Parliament, in 
accordance with Article 26 of Directiv e 86/609/EEC of 24 November 1986 on the 
approximation of laws, regulations and administ rative 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 drafted in accordance with the prov isions of the above 
mentioned directive whic h were published in 19942 and 19993, covering data on experimental 
animals collected in 1991 and 1996 respectively in the Member States, allowed only a limited 
amount of statistical analysis due to the absenc e of a consistent system of reporting the data. 
In 1997 an agreement was reached between the Commission and the comp etent authorities of 
the Member States to submit data for future re ports using a format of eight harmonized tables. 
The third and fourth statis tical reports published in 20034 and 20055 covering data collected in 
1999 and 2002 were based on these agreed harm onized 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 statistical reports, it ought to be stressed that there 
were some inconsistencies in the data submitte d by the Member States and also that in all 
cases except the report of 2003, one Member State collected data from an other year. The Fifth 
Statistical Report, published in 2007
6, contained for the first time data collected in the 10 
Member States which joined the EU in 2004. In the Sixth Statistical Report the complete set 
of standardized tables provided by all 27 Me mber States were successfully evaluated, 
although comparison of the results with previous  reports was essentially qualitative owing to 
the addition of data from  the new Member States. 
This Report includes data submitted by Romania and Bulgaria, which joined the EU in 2007. 
It gives an overview of the number of animals used in the Member States for experimental 
purposes for the year 2008 with the exception of  one Member State which provided data from 
2007.  
The Commission Staff Working Document accompanies the Report from the Commission to 
the Council and the European Parliament – Sixth Report on the Statistics on the Number of 
Animals used for Experimental and other Scien tific Purposes in the Member States of the 
European Union . The report summarizes the data and conclusions 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 
6 COM (2007) 675 final 
EN 5   EN II. DATA SUBMITTED A ND GENERAL ASSESSMENT 
II.1. Data submitted by the Member States  
All 27 Member States submitted the data in the agreed EU format.  
A quality control check on the set of data submitted for 2008 has been carried out and is 
essentially governed by four criteria based on cer tain relationships 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 purpo ses 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 'ani mals used for toxicological 
and other safety evaluation' which is broken down into types of products/endpoints in EU 
table 3; into Regulatory requireme nts in EU table 6; and into t ypes of toxicological tests in 
EU table 7. Therefore, the total of column 2.6 mu st be equal to the totals of tables 3, 6, 7 
and in addition table 8 'type of test s versus products' respectively.  
– The third relationship is that the sum of colu mn 2.4 and 2.5 of EU tabl e 2 must be equal to 
the total of EU table 5.  
– In the fourth relationship, the total of EU table 3 should be eq ual to the total of table 8.  
The last criterion has shown obvious weaknesse s when tested on the tables provided by the 
Member States and has lead to include an additional 5th qua lity check criterion.  
– Fifth: each individual total in th e total line of table 3 must be equal to each individual total 
in the total column of table 8 as the column headings are identical. 
For this Sixth report all the above  quality criteria have been fu lfilled by the Member States. It 
is therefore considered that th e data provided by the Member St ates affords a consistent base 
for a sound statistical analysis  of all eight EU tables.  
II.2. General assessment 
Each Member State is requested, pursuant to  Articles 13 of Directiv e 86/609/EEC, to submit 
to the Commission the statistical data on th e animals used for experimental and other 
scientific purposes. The data fo r this report covers the year 2 008 with the exception of France 
which provided data from 2007.  
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 purposes7 
allows the use of animals in experiments for ed ucation and training, but where the purposes of 
such experiments are not covered by the Dir ective, Member States will according to the 
Resolution apply national provisions which are no less severe than those of the Directive. 
                                                 
7 OJ C 331, 23.12.86, p. 2. 
EN 6   EN Therefore, a number of Member  States have also included animals covered by the Resolution 
in the report. 
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 2008. The purposes of 
the use of animals have been analysed, and so me of these purposes have been broken down 
further into more precise parameters. It also  considers different legislative requirements 
regarding the use of experiment al animals and the type of te sting carried out on different 
species.  
As the two newest Member States, Bulgaria an d Romania, have submitted data for the first 
time, it is in principle not possible to draw accurate quantitative conc lusions on the evolution 
of the use of animals for experi mental purposes in the EU by comparing data with those of the 
previous reports. However, as their total use am ounts to less than 1% of  the total number of 
animals used in 2008, some comparisons in tr ends have been attempted, and significant 
changes in use have been highlighted in the report.  
The second part of this report provides the indi vidual 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 
2008 in the Member States amounts to just ov er 12 million (with data from France from 
2007).  
As in previous reports rodents together with rabbits represen t more than 80% of the total 
number of animals used in the EU. Mice are by far the most commonly used species 
accounting for 59% of the total use,  followed by rats with 17%.  
The second most used group of animals was, as  in previous years, cold-blooded animals 
which represent almost 10%. The third largest gr oup of animals used was birds with a little 
over 6% of the total use. 
As stated in the previous two statistical reports no Great Apes were used in experiments in the 
EU in 2008.  
EN 7   EN II.3. Structure of the Report 
The report is divide d into two parts: 
A A global compilation and overview for the Europ ean Union of the statistical data of the 
Member States for 2008.  
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 th e end of each chapter. Ea ch table is illustrated 
by a graphical presentation to give a more  readable overview of  the EU situation. 
Similarly to results of the Report of 2005, for which France submitted statistical data for 
2004, the data analysed for this  Report includes sta tistical data from the year 2007 from 
France. Therefore, the totals used in this re port are a mixture of years. Comparisons were 
nevertheless made on this basis sinc e no other data were available. 
The reader is invited to take note that the numbering of tables and gr aphical 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.  
EN 8   EN PART A: COMPILATION AND OVERVIEW OF THE DATA 
OF 2008  
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 relates to the total number of  animals subdivided into  25 species used by the 
Member States. The second type of information re lates 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 consolid ated data on the number of animals used for 
experimental purposes, by species, submitted by 27 Member States. Whereas in previous 
years Malta had not used animals for scientific purposes, in 2008 this c ountry reported animal 
use for the first time. 
The total number of animals used in 2008 in the 27 Member States amounts to 12.0 million 
animals. It is important to note that the numbe r of animals used in the new Member States 
who joined the EU in 2008 (Bulgaria and Romani a) represents not even 1,0% of the total 
number of animals used in the EU 27.  
III.1.2. Treatment and interpreta tion of the data of Table 1.1 
In order to present an overall evaluation and s ubsequently a graphical analysis, animal species 
were grouped. The result of this exercise is presented in Table 1.2 at the e nd of this chapter. 
This grouping in Table 1.2 allows an overview of the species used and is illustrated in Figure 
1.1. 
It should also be pointed out that re-used animals are not included in the figures so that 
animals are not counted twice. 
EN 9   EN Figure 1.1
Percentages of animals used by classes in the Member
 States 
Mice 59,30%Prosimians+monkeys+a
pes 0,08%
Other Mammals 
0,05%Carnivores 
0,26% Artio+Perissodactyla 
1,39%
Birds 6,38%
Cold-blooded animals 
9,62%
Rabbits 2,78%
Guinea-Pigs 1,84%Other rodents 0,60%
Rats 17,70%
 
Rodents together with rabbits represent more than 80% of the total number of animals used. 
Mice (59,3%) and rats (17,6%) are by far the most commonly used species. 
The second most used group is represente d by cold-blooded animals namely reptiles, 
amphibians and fish at 9,6%. 
Birds is the next highest animal group used for experiment al purposes at 6,3%. 
The Artiodactyla and Perissodactyla group including horses, donkeys and crossbreeds 
(Perrissodactyla), pigs, goats, sheep and cattle (Artiodactyla) represents 1,4% 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 0,08% of the animals used in 2008. 
III.1.3. Comparison with the data  of the previous reports  
In this chapter, and the following chapters wh ere comparisons are addressed, the reader is 
invited to take note of the fact that in 1996, in 2002, in 2005 and for this report France has 
reported data respectively for 1997, 2001, 2004  and 2007 which does not allow a rigorous 
comparison between data reported for each year. 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 tr ends by comparing changes in proportions of 
use, expressed as a percentage. 
EN 10   EN Comparison between proportions of cla sses of animals used  in 1996, 1999, 2002, 2005 
and 2008 
Class of species 1996(*) 1999 2002(**) 2005(***) 2008(****) 
% Rodents-rabbits 81,3 86,9 78,0 77,5 82,2 
% Cold-blooded animals 12,9 6,6 15,4 15, 9,6 
% Birds  4,7 5 5,4 6,4 
% Artio and Perissodactyla  1,2 1,2 1,1 1,4 
(*) 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 (****) 27 Member States reporting for 2008, one for 2007 
Overall, the percentage of rodents and rabbits  shows some fluctuation, but remains close to 
80%. For cold-blooded animals the proportion used in 1996, in 2002 a nd 2005 is between 12 
to 15%. In 2008 the use of cold -blooded animals has dropped considerably to below 10%. 
However, in 1999 a much lower percentage of 6,6% was observed. 
Birds representing the third largest percentage of animals used, seems to be in constant 
increase over the years from 4 to 6,4%. The gr oup of horses, donkeys and cross-bred animals 
(artiodactyla) and pigs, goats,  sheep and cattle (perissodact yla) fluctuates at around 1%. 
Contrary to what would have been expected, th e effect of the inclusio n of the data of new 
Member States since 2005 i.e. Bulgaria and Roma nia, did not lead to an increase in the total 
number of animals, on the contrary, there is  a decrease of more than 116,500 animals.  
Table 1.0 contains a comparison of the change  that has taken place since 2008 for each 
species, expressed in number of animals per sp ecies, between EU 27 (data from 2008) and EU 
25 (data from 2005) (first three columns) and in  percentage per species (fourth column). The 
second half is a comparison between EU 25 (data of 2008 without Romania and Bulgaria) 
EN 11   EN Table 1.0 : Changes in species number and proportion between 2005 and 2008 
Species Number of 
animals 
in EU 25  
  
2005 Number 
of 
animals 
in EU 27 
 
2008 Change 
since 
2005 % 
change 
by 
species Change 
since 
2005 Number of 
animals 
EU 25  
2008 
excl. 
RO,BG % 
change 
by 
species  
1.a Mice (Mus musculus) 6430346 7122188 691842 10,76 630992 7061338 9,81 
1.b Rats (Rattus norvegicus) 2336032 2121727 -214305 -9,17 -223989 2112043 -9,59  
1.c Guinea-Pigs (Cavia 
porcellus) 257307 220985 -36322 -14,12 -46774 210533 -18,18  
1.d Hamsters (Mesocricetus ) 31535 32739 1204 3,82 759 32294 2,41 
1.e Other Rodents (other 
Rodentia) 64474 39506 -24968 -38,73 -24968 39506 -38,73  
1.f Rabbits (Oryctolagus 
cuniculus) 312681 333213 20532 6,57 17514 330195 5,60 
1.g Cats (Felis catus) 3898 4088 190 4,87 179 4077 4,59 
1.h Dogs (Canis familiaris) 24119 21315 -2804 -11,63 -2819 21300 -11,69  
1.i Ferrets (Mustela putorius 
furo) 2690 3208 518 19,26 518 3208 19,26  
1.j Other Carnivores 8711 2853 -5858 -67,25 -5858 2853 -67,25  
1.k Horses, donkeys and cross 
breds (Equidae) 5312 5976 664 12,50 633 5945 11,92  
1.l Pigs (Sus) 66305 92813 26508 39,98 26369 92674 39,77  
1.m Goats (Capra) 2146 3840 1694 78,94 1614 3760 75,21  
1.n Sheep (Ovis) 30021 30190 169 0,56 -212 29809 -0,71  
1.o Cattle (Bos) 36271 33952 -2319 -6,39 -2448 33823 -6,75  
1.p Prosimians (Prosimia) 677 1261 584 86,26 584 1261 86,26  
1.q New World Monkeys 
(Ceboidea) 1564 904 -660 -42,20 -660 904 -42,20  
-1.r Old World Monkeys 
(Cercopithecoidea) 8208 7404 -804 -9,80 -804 7404 -9,80  
1.s Apes (Hominoidea) 0 0 0 0,00 0 0 0,00 
1.t Other Mammals (other 
Mammalia) 9950 5704 -4246 -42,67 -4246 5704 -42,67  
1.u Quail (Coturnix coturnix) 9246 9626 380 4,11 371 9617 4,01 
1.v Other birds (other Aves) 649813 754485 104672 16,11 101999 751812 15,70  
1.w Reptiles (Reptilia) 2477 4101 1624 65,56 1624 4101 65,56  
1.x Amphibians (Amphibia) 74620 61789 -12831 -17,20 -17631 56989 -23,63  
1.y Fish (Pisces) 1749178 1087155 -662023 -37,85 -662073 1087105 -37,85  
1.z TOTAL 12117581 12001022 -116559 -0,96 -209326 11908255 -1,73  
There is an increase in the number of mice used sin ce 2005 of 691,842 which is 10,7% of the 
total number of mice used in 2005 and a decr ease for rats (9,2%) and fish (37,8%). The 
largest change in 2008, increase in  the use of mice, is almost entirely compensated for by the 
decrease in the use of fish. 
The total number of pigs, goats, prosimians, and reptiles has incr eased by between 40% – 
86,3%.
EN 12   EN The total number of rats, guinea-pigs, other r odents, dogs, cattle and other mammals as well 
as amphibians and fish used has decreased substantially since th e last report. When expressed 
in percentages these decreases range  from more than 40 to around 9%.  
The largest percentile change ha s, however, been noted in the decrease of the use of other 
carnivores. However, these species are no t used in great numb ers (from 8,711 to 2,853). 
There is also a large decr ease of 42,7% in the total num ber of 'other mammals'. 
It is also worth noting the large decrease in the use of new world monkeys of 42,2% as well as 
a decrease of 9,8% of old world monkeys. Pros imian use overall, however, has increased by 
86,3%.  
For species used in greater numbers, significant  increases occurred in 2008 for mice, rabbits, 
pigs and 'other birds' where percen tage changes ranged from 6,6 to 40%. 
The following animals which are normally used in fewer numbers show an increase in use: 
ferrets (19,3%), horses, donkeys and cross- breeds (12,5%), goats (78,9%) and reptiles 
(65,5%).  
As in 2002 and 2005, no great apes were used for e xperimental or other sc ientific purposes in 
2008. 
Member States provided examples of the type of species covered by category 'other' as 
follows:  
Other rodents:  gerbils, old world jerboas ( Jaculus jaculus ); chinchillas, beavers, ground 
squirrels, hamsters, grey dwarf hamsters ( Cricetulus migratorius ) and different species of 
mice. 
Other carnivores:  wild-life species used for zoologica l and ecological st udies e.g. foxes, 
badgers, seals, otters and fitchew. 
Other mammals:  boars, bats and shrews, llamas, mo les, European bison and red deer. 
Other birds:  mainly Japanese Quail ( coturnix japonica ) and bob-white qua il, poultry species, 
and zebra finches, canaries, parakeets, parro ts and farmed avian species for example, 
chickens. 
In the three columns in the second half of the table, the addition of data from Bulgaria, 
Romania has virtually no effect on the pr oportional changes between the species.  
Romania has little effect on the proportional changes between the species ranging from no 
change to very marginal variations per specie s. However, there is a net decrease of guinea 
pigs – 4%, and 10% for amphibians, when da ta from Bulgaria and Romania are excluded.
 
EN 13   EN Table 1.1: Total number of animals used for experimental purposes in the EU Member States 
Data of 2008 (*) 
Species AT BE BG CY CZ DK ET FI FR DE EL HU IE IT LV LT LU MT NL PL PT RO SP SK SL SE UK Totals 
a. Mice 177544 480681 16265 2114 54776 168164 28754 78446 1561809 1314493 19786 158799 71224 553000 6912 3827 3280 50 237681 123897 39811 44585 543680 69 42 10313 203112 1212243 7122188 
b. Rats  9928 108580 4513 0 21531 75850 5268 26058 392773 390853 4367 89375 11741 230347 2407 1194 430 44 105780 45824 6571 5171 175325 9692 1675 53141 3432 89 2121727 
c. Guinea-Pigs 3284 36554 3845 0 1902 5343 22 215 46030 35870 45 9743 91 13875 32 93 100 0 6062 6495 152 6607 12620 982 7 1766 29250 220985 
d. Hamsters 693 2124 182 0 251 4 120 302 12063 7061 0 215 68 717 0 0 0 0 3358 312 29 263 1262 0 0 864 2851 32739 
e.Other Rodents  47 1055   1233 1760 0 3142 3594 8392  356  1235   0 2439 11966   251 45 0 2033 1958 39506 
f. Rabbits 18761 42025 813 0 6304 2931 630 814 96427 97938 1498 8134 204 9706 48 199 20 0 7418 3086 99 2205 19626 679 307 1332 12009 333213 
g. Cats  2 78 11 0 45 154 0  1848 798 4 40 295 26 0 0 0 0 253 83  0 100 18 0 149 184 4088 
h. Dogs 41 788 15 0 552 271 0 54 4131 4450 44 686 557 943 0 0 0 0 1244 230  0 1046 4 0 1982 4277 21315 
i. Ferrets 14 324 0 0 122 117 0  800 55 0 0  0 0 0 0 0 472 0  0 287 0 0 39 978 3208 
j.Other 
Carnivores  0 0   45 101 0 761 0 410  0  0   0 10 520   5  0 53 948 2853 
k. horses, 
donkeys & 
cross-breeds  47 62 17  378 54 0 37 652 584 1 40 144 46   0 2562 529 6 14 90  0 423 290 5976 
l. Pigs 5086 2969 137  2013 6863  819 8768 12361 624 1193 224 3607  80 0 11729 11742 222 2 15121 22 3 1973 7255 92813 
m. Goats 39 195 80  174 107 0  1159 531 24 92  41   0 229 300   372 5 0 5 487 3840 
n. Sheep 142 356 250  1148 88  571 3573 4638 68 200 456 469   0 3486 2217 28 131 2386 9 4 152 9818 30190 
o. Cattle  574 657 126  799 939 0 300 3206 6252 72 93 4019 462   0 2236 7540 10 3 1091  0 1379 4194 33952 
p. Prosimians 0 0 0 0 0 0 0  718 543 0 0  0 0 0 0 0 0 0  0 0 0 0 0 0 1261 
q.N W Monkeys  0 0 0 0 0 0 0  233 305 0 5  18 0 0 0 0 73 0  0 8 0 0 0 262 904 
r.O W Monkeys 0 41 0 0 80 0 0  1797 1415 0 1  344 0 0 0 0 82 0  0 517 0 0 35 3092 7404 
s. Apes 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 
.t.Other 
Mammals  0 151   1774 243  84 0 541  16 32 151   0 202 1246   28 21 0 263 952 5704 
u. Quail 14 431 0 0 0 0 0  1548 1803 0 13  249 0 0 0 0 0 5100  9 138 120 0 201 0 9626 
v. Other birds 1367 17151 1477  148722 2820  5568 156814 53986 88 32554 582 32241  40 0 90890 27391 160 1196 52104 696 129 3432 125077 754485 
w. Reptiles  17 374   1012 221  317 758 192  108  454   0 121 248     0 170 109 4101 
x. Amphibians 277 2388 4800  3016 293  34 9451 10815 200 1182  2432  149 0 870 1221   704  0 641 23316 61789 
y. Fish 2579 28386 50  54836 31245  21078 20228 67496 1200 2077 23198 13955   0 600 23859 25941 3800  71098 25 0 211459 484045 1087155 
z.TOTAL 220456 725370 32581 2114 300713 297568 34794 138600 2328380 2021782 28021 304922 112835 864318 9399 5582 3830 694 501056 275888 50888 60186 8978 59 19260 12438 484604 2266884 12001022 
(*) France is reporting for 2007 
 
EN 14   EN Table 1.2: Classes of animals used for experimental purposes in the EU Member States 
Data of 2008 (*) 
Species AT BE BG CY CZ DK ET FI FR DE EL HU IE IT LV LT LU MT NL PL PT RO SP SK SL SE UK Totals 
Mice 177544 480681 16265 2114 54776 168164 28754 78446 1561809 1314493 19786 158799 71224 553000 6912 3827 3280 50 237681 123897 39811 44585 543680 6 942 10313 203112 1212243 7122188 
Rats  9928 108580 4513 0 21531 75850 5268 26058 392773 390853 4367 89375 11741 230347 2407 1194 430 44 105780 45824 6571 5171 175325 9692 1675 53141 343 289 2121727 
Guinea-Pigs 3284 36554 3845 0 1902 5343 22 215 46030 35870 45 9743 91 13875 32 93 100 0 6062 6495 152 6607 12620 982 7 1766 29250 220985 
Hamsters + 
other rodents 740 3179 182 0 1484 1764 120 3444 15657 15453 0 571 68 1952 0 0 0 0 5797 12278 29 263 1513 45 0 2897 4809 72245 
Rabbits  18761 42025 813 0 6304 2931 630 814 96427 97938 1498 8134 204 9706 48 199 20 0 7418 3086 99 2205 19626 679 307 1332 12009 333213 
Cold-blooded 
animals (1) 2873 31148 4850 0 58864 31759 0 21429 30437 78503 1400 3367 23198 16841 0 149 0 600 24850 27410 3800 0 71802 25 0 212270 507470 1153045 
Birds (2)  1381 17582 1477 0 148722 2820 0 5568 158362 55789 88 32567 582 32490 0 40 0 0 90890 32491 160 1205 52242 816 129 3633 125077 764111 
Artio+perisso
dactyla (3) 5888 4239 610 0 4512 8051 0 1727 17358 24366 789 1618 4843 4625 0 80 0 0 20242 22328 266 150 19060 36 7 3932 22044 166771 
Carnivores  57 1190 26 0 764 643 0 815 6779 5713 48 726 852 969 0 0 0 0 1979 833 0 0 1438 22 0 2223 6387 31464 
Prosimians+
monkeys 
+apes  0 41 0 0 80 0 0 0 2748 2263 0 6 0 362 0 0 0 0 155 0 0 0 525 0 0 35 3354 9569 
Other 
mammals 0 151   1774 243  84 0 541  16 32 151   0  202 1246   28 21 0 263 952 5704 
             
 TOTAL  220456 725370 32581 2114 300713 297568 34794 138600 2328380 2021782 28021 304922 112835 864318 9399 5582 3830 694 501056 275888 50888 60186 897 859 19260 12438 484604 2266884 12001022 
 
Species % AT BE BG CY CZ DK ET FI FR DE EL HU IE  IT LV LT LU MT NL PL PT RO SP SK SL SE UK Totals 
Mice 80,53 66,27 49,92 100,00 18,22 56,51 82,64 56,60 67,08 65,02 70,61 52,08 63,12 63,98 73,54 68,56 85,64 7,20 47,44 44,91 78,23 74,08 60,55 36,04 8 2,92 41,91 53,48 59,35 
Rats  4,50 14,97 13,85 0,00 7,16 25,49 15,14 18,80 16,87 19,33 15,58 29,31 10,41 26,65 25,61 21,39 11,23 6,34 21,11 16,61 12,91 8,59 19,53 50,32 13,47 1 0,97 15,14 17,68 
Guinea-Pigs 1,49 5,04 11,80 0,00 0,63 1,80 0,06 0,16 1,98 1,77 0,16 3,20 0,08 1,61 0,34 1,67 2,61 0,00 1,21 2,35 0,30 10,98 1,41 5,10 0,06 0,36 1,29 1,84 
Hamsters + 
other rodents 0,34 0,44 0,56 0,00 0,49 0,59 0,34 2,48 0,67 0,76 0,00 0,19 0,06 0,23 0,00 0,00 0,00 0,00 1,16 4,45 0,06 0,44 0,17 0,23 0,00 0,60 0,21 0,60 
Rabbits  8,51 5,79 2,50 0,00 2,10 0,98 1,81 0,59 4,14 4,84 5,35 2,67 0,18 1,12 0,51 3,57 0,52 0,00 1,48 1,12 0,19 3,66 2,19 3,53 2,47 0,27 0,53 2,78 
Cold-blooded 
animals (1) 1,30 4,29 14,89 0,00 19,57 10,67 0,00 15,46 1,31 3,88 5,00 1,10 20,56 1,95 0,00 2,67 0,00 86,46 4,96 9,94 7,47 0,00 8,00 0,13 0,00 43,80 22,39 9,6 1 
Birds (2)  0,63 2,42 4,53 0,00 49,46 0,95 0,00 4,02 6,80 2,76 0,31 10,68 0,52 3,76 0,00 0,72 0,00 0,00 18,14 11,78 0,31 2,00 5,82 4,24 1,04 0,75 5,52 6,37 
Artio+perisso
dactyla (3) 2,67 0,58 1,87 0,00 1,50 2,71 0,00 1,25 0,75 1,21 2,82 0,53 4,29 0,54 0,00 1,43 0,00 0,00 4,04 8,09 0,52 0,25 2,12 0,19 0,06 0,81 0,97 1,39 
 Carnivores  0,03 0,16 0,08 0,00 0,25 0,22 0,00 0,59 0,29 0,28 0,17 0,24 0,76 0,11 0,00 0,00 0,00 0,00 0,39 0,30 0,00 0,00 0,16 0,11 0,00 0,46 0,28 0,26 
Prosimians+
monkeys+ 
apes  0,00 0,01 0,00 0,00 0,03 0,00 0,00 0,00 0,12 0,11 0,00 0,00 0,00 0,04 0,00 0,00 0,00 0,00 0,03 0,00 0,00 0,00 0,06 0,00 0,00 0,01 0,15 0,08 
 Other 
mammals 0,00 0,02 0,00 0,00 0,59 0,08 0,00 0,06 0,00 0,03 0,00 0,01 0,03 0,02 0,00 0,00 0,00 0,00 0,04 0,45 0,00 0,00 0,00 0,11 0,00 0,05 0,04 0,05 
 Mice                              
 TOTAL  100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 
FR(*) France reporting for 2007 
(1) reptiles + amphibians + fish 
(2) Quails and other birds 
(3) Horses, donkeys, and cross breeds  + pigs + goats and sheep +cattle 
(4) Cats + dogs + ferrets + other carnivores 
 
EN 15   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 27 Member States are reported in Table 1.3 at the end of this 
chapter. The consolidated table 1.3 only indicates species for which the origin must be reported.  
In addition, EU Table 1.3 contains information on 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 European Union. 
Figure 1.2 represents the percenta ge of animals from the reported origin 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 clearly th at the majority of the species originated from EU countries. However, 
certain species such as cats, dogs  and ferrets and old world monkeys are also of non-European 
origin.  
 
EN 16   EN 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 previous 
reports. It should be noted however, that for the fi rst time in 2005 the prosimians were all of EU 
origin and remain so for this report. A simila r trend can also be observed with the new world 
monkeys where almost all originate from either  EU Member States or  countries which are a 
party to the Council of Europe Convention ETS  123. Finally, also old world monkeys coming 
from the EU increased from about 26% in 2005 to more than 50% in 2008. On the other hand the 
number of cats of EU origin also increased whereas dogs and ferrets of non-European origin 
have remained unchanged since the last report. 
 
EN 17   EN Table 1.3: Number of animals used in relation to their place of origin 
Data of 2008 (*) 
1.1Species 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) 7122188 6042205 900230 21382 158371 3768 
1.b. Rats (Rattus norvegicus) 2121727 1761785 329385 9844 20713 3035 
1.c. Guinea-Pigs (Cavia porcellus) 220985 161973 56167 2051 792 962 
1.d. Hamsters (Mesocricetus ) 32739 24999 5476 1074 1190 54 
1.f. Rabbits (Oryctolagus cuniculus) 333213 315006 14753 364 3087 15958 
1.g. Cats (Felis catus) 4088 2306 726 14 1042 1181 
1.h. Dogs (Canis familiaris) 21315 12467 2885 309 5654 4178 
1.i. Ferrets (Mustela putorius furo) 3208 1847 442 0 919 64 
1.p. Prosimians (Prosimia) 1261 718 543 0 0 33 
1.q. New World Monkeys (Ceboidea) 904 816 83 5 0 346 
1.r. Old World Monkeys (Cercopithecoidea) 7404 3213 850 5 3336 1509 
1.s. Apes (Hominoidea) 00 0 0 0 0  
1.u. Quail (Coturnix coturnix) 9626 7824 1500 0 302 0 
1.z. TOTAL 9878658 8335159 1313040 35048 195406  
       
* France: data of 2007       
       
Note 1: Column 1.5 concerns only those me mber countries of the Council of Europe wh ich, at the beginning of the reporting perio d, are Parties to the Convention ETS 123. Thus an updated list of those 
countries has to be used when filling this column 
Note 2: Only species for which the 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 column 1.2.    
 
EN 18   EN III.3. Results of EU Table 2: Purposes of the experiments  
III.3.1. The data on purposes of the experiments The consolidated data on purposes of the expe riments of the 27 Member  States are presented 
in Table 2.1 at the e nd of this chapter. 
III.3.2. Treatment and inte rpretation of the data  
Table 2.2 presents the results of the consolidat ed data of the purposes of the procedures 
carried out in the 27 Member St ates in 2008. In order to facilit ate the presentation of results 
some species and some purposes were grouped in Table 2.2. 
The percentage of the number of animals used  for selected purposes is presented in Figure 
2.1.  
Figure 2.1 
Purposes of experiments
Research and develop 
human +veterin+dentist 
22,8%Fundamental biology 
studies 38,1%Diagnosis of disease 
1,6%Other 12,2%
Education and training 
1,7%
Production and quality 
control human medicine 
and dentistry  10,9%Production and quality 
control veterinary 
medicine 4%Toxicological and other 
safety evaluation 8,7%
 
More than 60% of animals were used in re search and development for human medicine, 
veterinary medicine, dentistry and in fundamental biological studies. 
Production and quality control of products a nd devices in human me dicine, veterinary 
medicine and dentistry required the use of  14,9% of the total number of animals. 
Toxicological and other safety ev aluation represents 8,7% of the total number of animals used 
for experimental purposes.  
Other purposes of procedures represents 12% of  the total number of animals and covers a 
wide range of experiments su ch as virology, immunology fo r production of monoclonal and 
polyclonal antibodies, physiology of foetal-maternal interaction in mouse gene transgensis, 
 
EN 19   EN oncological treatment, pharmaceutical research and development, combined drug testing and 
genetics. 
III.3.3. Comparison with the data  of the previous report  
The comparison aims to detect changes in trends rather than draw formal conclusions. The 
most significant change that has taken place sinc e 2005 is that the number of animals used for 
research and development for human medicine, dentistry and veterinary  medicine has dropped 
sharply from 31% to 22,8% (in terms of anim al numbers the decrease is from 3,746,028 to 
2,733,706). To be noted in particul ar is the significant reducti on of more than 800,000 cold-
blooded animals since the last report of 2005. On  the other hand, the percentage of animals 
used for fundamental biological research has increased from 33% to 38% (that is, from 
4,035,470 to 4,575,054) as well as for 'other purpos es', from 8% to 12%. It should be 
underlined that both fundamental biology and research and development in human and veterinary medicine are the areas using by far th e highest number of animals for experimental 
purposes in the EU. 
The number of animals used for toxicological  and other safety ev aluation has remained 
virtually unchanged since the la st report and amounts to 8,7% of  the total number of animals 
used for experimental purposes in th e EU. This represents 1,042,153 animals. 
In general the number of animals used for production and quality c ontrol of devices for 
medicine, veterinary medicine and dentis try has also remained unchanged since 2005. 
However, regarding the use by species, the use of mice and rabbits has increased substantially 
for production and quality control of products an d devices for human medicine and dentistry. 
One Member State indicated that funding had been  made available for pre-clinical trials for 
human medicine, which lead to an incr ease in use of experimental animals. 
Another Member State using a large number of rabbits for pr oduction and quality control of 
veterinary medicine indicated that the laborator y responsible for that increase had reported the 
data in the wrong column, that is, they s hould have been repor ted under production and 
quality control of human medicine and dentis try rather than for products and devices for 
veterinary medicine. The increase was due to the production of polyclonal antibodies to 
improve transplant in human medicine. However,  it was no longer possible to correct the error 
in the consolidated report. 
Regarding increases in othe r purposes of use,  there is a substantial increase in the use of mice, 
pigs and birds for 'fundamental biological  research' and in 'other experiments'. 
Several Member States confirmed that the increase in the use of  mice for fundamental 
biological research is attribut ed to the new research possib ilities offered by the transgenic 
species. These animal models are being used bot h for human and animal health studies. An 
increase was also reported for the purpose of  experiments in anatomy and developmental 
biology, physiology, genetics and cancer rese arch, and for immunology and microbiology. 
There are several reasons for th e increase in the use of pigs in ‘fundamental biological’ and 
also in ‘other studies’. One Member State us ing a large number of pigs for fundamental 
biological studies and for other procedures indicated that in recent years funding for projects 
relating to cardiovascular research has increased  significantly. The same applies in the case of 
experimental surgery which is taking place in many hospitals in the same Member State. 
Another area using an increased number of pi gs relates to pig dise ase studies, including for 
 
EN 20   EN example the observation of vaccine effectiveness.  It was reported that the increase was also 
due to fundamental research on pigs’ enzyme s and digestive functions, and because the 
tissues and organs of transgenic pigs are used for transplants in humans.  
The large number of birds used for fundamental  biological research in one Member State was 
due to a campaign of bird ring ing. The increase of the numb er of birds used for 'other 
experiments' was reported to be due to parasitology/immunology studies and to the 
development of genetically modified birds. 
Table 2.2: Number of animals used  for selected purposes versus species 
Species Biological 
studies of 
a 
fundament
al nature Research,
developm
ent and 
quality 
control of 
products 
and 
devices 
for human 
medicine 
and 
dentistry 
and for 
veterinary 
medicine  
Toxicologic
al and other 
safety 
evaluations 
(including 
safety 
evaluation 
of products) Diagnosi
s of 
disease  Education 
and 
training Other Total 
Mice  3080775 2624856 398199 137578 82606 798174 7122188
Rats  595542 1060290 294683 22997 59412 88803 2121727
Other rodents 44240 195427 33858 3145 7826 8734 293230
Rabbits 17813 212618 39987 3376 3326 56093 333213
Carnivores 4804 11378 11964 1360 515 1443 31464
Artio+perissodactyla 55080 56359 8996 4620 13134 28582 166771
Prosimians+monkeys+apes 1213 1260 6507 153 10 426 9569
Other mammals  5279 177 0 12 25 211 5704
Birds 292895 247618 53477 8415 11444 150262 764111
Cold-blooded animals 477413 113766 194482 3651 29159 334574 1153045
TOTAL 4575054 4523749 1042153 185307 207457 1467302 12001022
Figure 2.2 presents the number of animals used fo r selected purposes by classes of species.  
The highest number of mice and rats is attributed to funda mental biological studies and 
research, development and quality control of products and devices for medicine, dentistry and veterinary medicine. It is not eworthy that a high number of co ld-blooded animals have been 
used for 'other purposes' as well as for 'b iological studies of a fundamental nature'.
 
One can observe a significant reduction in the us e of cold-blooded animals for research and 
development of devices for human and veterinary  medicine and for dentistry since the last 
report of 2005.  
 
EN 21   E 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
0500000100000015000002000000250000030000003500000Figure 2.2
Species and experimental purposes
 
 
EN 22   EN Table 2.1: Number of animals used in  experiments for selected purposes  
Purposes versus species 
data of 2008*  
2.1.Species 2.2.Biological 
studies of a 
fundamental 
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. Production 
and quality control 
of products and 
devices for human 
medicine and 
dentistry 2.5. Production 
and quality 
control of 
products and 
devices for 
veterinary 
medicine 2.6. Toxicological and 
other safety evaluations 
(including safety 
evaluation of products 
and devices for human 
medicine and dentistry 
and for veterinary 
medicine 2.7. 
Diagnosis of 
disease 2.8. 
Education 
and training 2.9. Other 2.10. Total 
1.a. Mice (Mus musculus) 3080775 1597381 856048 171427 398199 137578 82606 798174 7122188 
1.b. Rats (Rattus norvegicus) 595542 840909 181140 38241 294683 22997 59412 88803 2121727 
1.c. Guinea-Pigs (Cavia porcellus) 10632 44344 103852 17265 31883 1940 5804 5265 220985 
1.d. Hamsters (Mesocricetus ) 6994 8041 376 12513 1580 278 520 2437 32739 
1.e. Other Rodents (other Rodentia) 26614 9006 30 0 395 927 1502 1032 39506 
1.f. Rabbits (Oryctolagus cuniculus) 17813 29764 131031 51823 39987 3376 3326 56093 333213 
1.g. Cats (Felis catus) 560 1738 57 679 322 124 97 514 4091 
1.h. Dogs (Canis familiaris) 1814 4405 157 2070 11077 1111 362 316 21312 
1.i. Ferrets (Mustela putorius furo) 551 1287 564 8 269 45 56 428 3208 
1.j. Other Carnivores (other Carnivora) 1879 75 0 338 296 80 0 185 2853 
1.k. Horses, donkeys and cross breds 
(Equidae) 1402 728 224 2559 22 239 489 313 5976 
1.l. Pigs (Sus) 23531 22799 423 9001 8065 1452 8134 19408 92813 
1.m. Goats (Capra) 1098 721 93 26 43 90 422 1347 3840 
1.n. Sheep (Ovis) 9727 4098 6020 2149 409 1616 1243 4928 30190 
1.o. Cattle (Bos) 19322 3990 214 3314 457 1223 2846 2586 33952 
1.p. Prosimians (Prosimia) 568 0 0 0 543 150 0 0 1261 
1.q. New World Monkeys (Ceboidea) 235 235 33 0 270 0 0 131 904 
1.r. Old World Monkeys (Cercopithecoidea) 410 761 231 0 5694 3 10 295 7404 
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0 0 0 
1.t. Other Mammals (other Mammalia) 5279 86 28 63 0 12 25 211 5704 
1.u. Quail (Coturnix coturnix) 5520 57 0 0 2170 9 1575 295 9626 
1.v. Other birds (other Aves) 287375 77748 10593 159220 51307 8406 9869 149967 754485 
1.w. Reptiles (Reptilia) 3781 94 0 0 0 0 147 79 4101 
1.x. Amphibians (Amphibia) 32780 1914 0 0 291 202 12213 14389 61789 
1.y. Fish (Pisces) 440852 83525 20418 7815 194191 3449 16799 320106 1087155 
1.z. TOTAL 4575054 2733706 1311532 478511 1042153 185307 207457 1467302 12001022 
(*) France is reporting for 2007 
 
EN 23   EN III.4. Results of EU Table 3: Toxicological and safety evaluation by type of 
product/endpoint  
III.4.1. The data on toxicologi cal and safety evaluation by  type of product/endpoint 
The consolidated table giving th e number of animals used for toxicological and other safety 
evaluation of products (EU Table 3) in 27 Memb er States in 2008 is pr esented in Table 3.1 at 
the end of this chapter. In table 3.1 the numbe r of animals used for toxicological or other 
safety evaluation is broken down into type s of products for which testing was required. 
The percentage of the number of animals used for different types of pr oduct is presented in 
Figure 3. 
III.4.2. Treatment and interpretation of the data 
Figure 3
Number of animals used in toxicological and other safety 
evaluation 
3.10    Other  toxicological 
or safety evaluations
21,45%3.9   Potential  or actual 
contaminents in the 
general environment which 
do not appear in other 
columns
6,323.8    Products/ 
substances used or 
intended to be used mainly 
as additives in food for 
animal consumption
5,20%
3.7    Products/ 
substances used or 
intended to be used mainly 
as additives in food for 
human consumption
0,60%
3.6    Products/ 
substances used or 
intended to be used mainly 
as cosmetics or  toiletries
0,19%
3.5   Products/ 
substances used or 
intended to be used mainly 
in the household
0,41%
3.3     Products/ 
substances used or 
intended to be used mainly 
in agriculture
7,11%3.4   Products/ 
substances used or 
intended to be used mainly 
in industry
7,913.2    Products/ 
substances or devices for 
human medicine and 
dentistry and for veterinary 
medicine
50,81%
 
The number of animals used for toxicologica l and other safety evaluation for different 
products or environmental test schemes am ounts to 1,042,153, which represents 8,7% of the 
total number of animals used for experimental  purposes in 2008 (see Table 2.1, column 2.6).  
Toxicological or other safety ev aluations are split up ac cording to the type of sector for which 
they are intended. The percentage of animals us ed for toxicological evaluation of three groups 
of products/substances, i.e. additives in food for human consumption, cosmetics and 
household products, is very small (1,18%) wh en compared to the other product groups. 
 
EN 24   EN Products or devices used for human medicine, ve terinary medicine and dentistry represents 
50,8% of the animals used for toxicol ogical or other safety evaluations. 
The group of products/substances falling under th e scrutiny of Member States authorities 
concerned with safety of h ealth and of the environment by chemical products, such as 
industrial chemicals and pesticides, used 15% of the animals for toxicological and other safety 
evaluations.  
There is a clear decrease in the number of anim als used for toxicological tests for products 
intended for industry, for agriculture and for pot ential contaminants of the environment. The 
decrease ranges respectively from above 96,000 to about 82,000; from below 98,000 to about 74,000 and from above 84,000 to about 65,000 in comparison to the data submitted in the 2005 statistical report. 
There is also a significant decrease in the numbe r of animals used for testing of products for 
cosmetics and toiletries ranging from 5,500 to ju st below 2,000 (a 65% drop). This change has 
to be seen in light of the lega l requirement to phase out animal testing for cosmetics in the EU 
where a ban on testing has been applicable since 2009 for all hum an health effects with the 
exception of three toxicological end-points: repe ated-dose toxicity, repr oductive toxicity and 
toxicokinetics. The year 2013 is the deadline for a marketing ban for cosmetics tested for 
these remaining specific health effects.  
There is however also a sign ificant increase since 2005 in th e number of animals used for 
tests for additives in food for animal consum ption (from 34,225 to 54,164). This may reflect 
the animal feed sanitary concerns expresse d in the EU after the discovery of harmful 
contaminants in such products over the last 10 years.  
It should also be noted that in comparison to th e 2005 report, there is a si gnificant increase in 
the number of animals used for ‘other’ toxico logical or safety ev aluation (ranging from 
around 180,000 to about 220,000). Member States report ed that this particular use of animals 
concerned new methods and tests, such as te sts on transmission of microcystins on embryonic 
membrane, bioassays, toxicity evaluation for hu mans via the environment, and control of 
safety of toys. 
 
EN 25   EN Table 3.1: Number of animals used in toxicological and other safety evaluation 
Products versus species 
Data of 2008* 
3.1.Species 3.2. Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 3.3. 
Products/ 
substance
s used or 
intended 
to be used 
mainly in 
agriculture 3.4.Products
/ substances 
used or 
intended to 
be used 
mainly in 
industry 3.5.Products
/ substances 
used or 
intended to 
be used 
mainly in the 
household 3.6.Products
/ substances 
used or 
intended to 
be used 
mainly as 
cosmetics or 
toiletries 3.7.Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 3.8.Products
/ substances 
used or 
intended to 
be used 
mainly as 
additives in 
food for 
animal 
consumption 3.9.Potential 
or actual 
contaminants 
in the general 
environment 
which do not 
appear in 
other 
columns 3.10.Other 
toxicological 
or safety 
evaluations 3.11.Total 
1.a. Mice (Mus musculus) 188227 10129 20249 1922 880 2818 1680 9433 162919 398257 
1.b. Rats (Rattus norvegicus) 187283 31421 41562 1709 174 2764 303 2932 26496 294644 
1.c. Guinea-Pigs (Cavia porcellus) 23152 2830 3679 0 38 24 7 0 2192 31922 
1.d. Hamsters (Mesocricetus ) 1559 0 21 0 0 0 0 0 0 1580 
1.e. Other Rodents (other Rodentia) 0 164 0 0 0 0 0 204 27 395 
1.f. Rabbits (Oryctolagus cuniculus) 30516 2696 4453 50 153 11 7 12 2127 40025 
1.g. Cats (Felis catus) 312 0 0 0 0 0 0 0 10 322 
1.h. Dogs (Canis familiaris) 9888 340 16 0 0 0 0 0 833 11077 
1.i. Ferrets (Mustela putorius furo) 269 0 0 0 0 0 0 0 0 269 
1.j. Other Carnivores (other Carnivore) 296 0 0 0 0 0 0 0 0 296 
1.k. Horses, donkeys and cross breds 
(Equidae) 22 0 0 0 0 0 0 0 0 22 
1.l. Pigs (Sus) 3169 90 0 0 0 100 4584 64 66 8073 
1.m. Goats (Capra) 21 14 0 0 0 0 0 8 0 43 
1.n. Sheep (Ovis) 408 0 0 0 0 0 0 0 1 409 
1.o. Cattle (Bos) 409 4 0 0 0 0 0 0 44 457 
1.p. Prosimians (Prosimia) 543 0 0 0 0 0 0 0 0 543 
1.q. New World Monkeys (Ceboidea) 200 0 0 0 0 0 0 0 70 270 
1.r. Old World Monkeys (Cercopithecoidea) 5121 0 0 0 0 0 0 0 573 5694 
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0 0 0 0 
1.t. Other Mammals (other Mammalia) 0 210 0 0 0 0 0 0 0 210 
1.u. Quail (Coturnix coturnix) 64 2110 0 0 0 0 0 0 0 2174 
1.v. Other birds (other Aves) 8838 2116 30 0 0 0 39553 97 320 50954 
1.w. Reptiles (Reptilia) 0 0 0 0 0 0 0 0 0 0 
1.x. Amphibians (Amphibia) 179 108 0 0 0 0 0 0 4 291 
1.y. Fish (Pisces) 69021 21915 12416 601 722 523 8030 53062 27936 194226 
1.z. TOTAL 529497 74147 82426 4282 1967 6240 54164 65812 223618 1042153 
(*) France reporting for 2007 
 
EN 26   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 
27 Member States is presented in Ta ble 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 2008 the number of animals used for the study of both animal and human diseases 
represented about 6,322,000 animals which is more  than half (52%) th e 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 proportion of animals used for studies of huma n diseases represents more than 90% of the 
total number of animals used  for all disease studies. 
Figure 4.1
Proportion of animals used for the studies of diseases
Human cancer 
(excluding evaluations 
of carcino hazards ) 
13,5%Human nervous and 
mental disorders 
22,6%Human cardiovascular 
diseases
6,4%
Other human diseases 
47,8%Specific to animal 
diseases
9,7%
 
Overall in 2008 there is a 50% decrease in the number of animals used for studies on specific 
animal diseases - from 1,329,000 to 614,000. In partic ular, a significant cha nge occurred in the 
use of cold-blooded species where figures decreased from around 954,000 animals in 2005 to 
43,914 in 2008.  
Interesting to note is that despite the overall de crease, the use of mice increased substantially 
in 2008. Around 30% of the increase  (about 681,000) can be attribut ed to different studies of 
diseases (see also observations under chapter III.3.3). 
 
EN 27   EN Some Member States confirmed th at the increase of the use of animals in general, or mice in 
particular in table 4, is also reported under several headings of table 2, such as fundamental 
biological research and research and develo pment of products for human and veterinary 
medicine and even production and control proce ss for human and veterinary medicine. For the 
2008 data one Member States indicated, however , that the increase of use of mice was 
primarily attributed to funda mental biological research. 
It should be remembered that the studies on specific animal diseases are important in light of 
epidemic diseases affecting animals such as in the case of foot and mouth disease, swine fever 
and more recently avian flew. However, animals have also been used in studies on genetic 
diseases. According to 2008 data there has been  more than a 50% reduction in animals used 
for studies on animal diseases. This could be  because there have been no new significant 
animal disease epidemics in 2008 or in the preceding years.  
The above observation is not necessa rily reflected in the use of all species in  particular for the 
use of mice and other birds by some Member States. 
Regarding the specific animal di seases studies linked to the in crease in the number of birds, 
Member States reported studies on bird flu, Gu mboro disease and bronchi tis including studies 
on quality and safety of vaccines. 
 
EN 28   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 2008 * 
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) 249486 858612 803038 1883499 292772 4087407
1.b. Rats (Rattus norvegicus) 125904 489630 43336 600979 16909 1276758
1.c. Guinea-Pigs (Cavia porcellus) 2856 5004 262 47326 3252 58700
1.d. Hamsters (Mesocricetus ) 1940 2986 791 6751 3104 15572
1.e. Other Rodents (other Rodentia) 673 6737 239 5093 4617 17359
1.f. Rabbits (Oryctolagus cuniculus) 5373 1386 1781 28138 6983 43661
1.g. Cats (Felis catus) 14 169 0 126 1930 2239
1.h. Dogs (Canis familiaris) 1233 207 144 4544 3810 9938
1.i. Ferrets (Mustela putorius furo) 20 184 0 2153 105 2462
1.j. Other Carnivores (other Carnivore) 72 0 0 468 411 951
1.k. Horses, donkeys and cross breds 
(Equidae) 3 0 0 154 1614 1771
1.l. Pigs (Sus) 4638 417 100 9589 17299 32043
1.m. Goats (Capra) 170 39 87 478 1014 1788
1.n. Sheep (Ovis) 597 601 24 8065 6833 16120
1.o. Cattle (Bos) 243 36 0 2860 13756 16895
1.p. Prosimians (Prosimia) 0 40 0 311 370 721
1.q. New World Monkeys (Ceboidea) 7 101 0 419 21 548
1.r. Old World Monkeys (Cercopithecoidea) 111 261 6 3173 8 3559
1.s. Apes (Hominoidea) 0 0 0 0 0 0
1.t. Other Mammals (other Mammalia) 29 55 5 887 449 1425
1.u. Quail (Coturnix coturnix) 0 400 0 177 413 990
1.v. Other birds (other Aves) 4769 4563 47 21365 194727 225471
1.w. Reptiles (Reptilia) 0 90 0 0 934 1024
1.x. Amphibians (Amphibia) 362 603 2886 10852 2022 16725
1.y. Fish (Pisces) 5841 57964 2458 381109 40958 488330
1.z. TOTAL 404341 1430085 855204 3018516 614311 6322457
France reporting for 2007 
 
EN 29   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  249486 858612 803038 1883499 292772 4087407
Rats  125904 489630 43336 600979 16909 1276758
Guinea-Pigs 2856 5004 262 47326 3252 58700
Other rodents 2613 9723 1030 11844 7721 32931
Rabbits  5373 1386 1781 28138 6983 43661
Carnivores 1339 560 144 7291 6256 15590
Artio + Perrisodactyla 5651 1093 211 21146 40516 68617
Prosimians+Monkeys+Apes 118 402 6 3903 399 4828
Other Mammals  29 55 5 887 449 1425
Birds 4769 4963 47 21542 195140 226461
Cold-blooded animals 6203 58657 5344 391961 43914 506079
TOTAL 404341 1430085 855204 3018516 614311 6322457
       
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  6,10 21,01 19,65 46,08 7,16 100,00
Rats  9,86 38,35 3,39 47,07 1,32 100,00
Guinea-Pigs 4,87 8,52 0,45 80,62 5,54 100,00
Other rodents 7,93 29,53 3,13 35,97 23,45 100,00
Rabbits  12,31 3,17 4,08 64,45 15,99 100,00
Carnivores 8,59 3,59 0,92 46,77 40,13 100,00
Artio + Perrisodactyla 8,24 1,59 0,31 30,82 59,05 100,00
Prosimians+Monkeys+Apes 2,44 8,33 0,12 80,84 8,26 100,00
Other Mammals  2,04 3,86 0,35 62,25 31,51 100,00
Birds 2,11 2,19 0,02 9,51 86,17 100,00
Cold-blooded animals 1,23 11,59 1,06 77,45 8,68 100,00
 
EN 30   EN Species of Table 4.1 were grouped into classe s of animals and presented in Table 4.2. The 
relative percentage of animals per class of species used in studies  by type of di sease 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.  
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 to animal diseases %
Other human diseases %
Human cancer (excluding evaluations of
carcino hazards ) %
Human nervous and mental disorders %
Human cardiovascular diseases %
 
The top of each bar shows the relative percentage  of animals used for studies on specific 
animal diseases. Significant numbers of both artiodactyla  and perissodactyla  and birds are 
used for this purpose. Member States reported th at it is still current practice to test vaccines 
on these species. However, in some Member States only birds are used if the infection concerns bird species. 
The data on the use of most species for all type s of studies on both human and animal diseases 
show a great similarity to the data of 2005. Howe ver, there is a substantial decrease in the use 
of ‘other mammals’ for studies of human diseas es in particular 'other human diseases', 
whereas the opposite is observed for cold-blood ed animals which have been more widely 
used in studies on human diseases  rather than animal diseases. 
 
EN 31   EN III.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 producti on and quality control of products for human 
medicine and dentistry a nd for veterinary medicine 
The consolidated table for the 27 Member St ates 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 at the end of this chapter. 
III.6.2. Treatment and inte rpretation of the data  
The number of animals used in tests for th e production and quality control of products for 
human medicine and dentistry and for veterinary medicine represents 14,9% of the total 
number of animals used for experimental pur poses. Figure 5 gives the percentages of the 
animals used to satisfy the different regiona l regulatory requirements in this area.  
Figure 5
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
2,6
41,1
0,049
2,6
47,0
6,40,00 10,00 20,00 30,00 40,00 50,00
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
requirements
 
The largest proportion of animals in this area (47%) wa s used to satisfy requirements from 
several pieces of legi slation (from national, the EU, the Council of Eu rope member country 
legislation, and from legislation outside of the EU (Fig 5)). Th e testing carried out to satisfy 
EU legislation including the European Pharm acopoeia covered 41,1% of the animals used in 
this area. 
In comparison to the report of 2005 there is a ne t decrease in the number of animals used to 
satisfy simultaneously several pieces of legisla tion. On the other hand there is a net increase 
of tests carried out for the European legisl ation (including the European Pharmacopoeia). 
 
EN 32   EN Consequently, there is a net de crease in the number of anim als used to satisfy national 
legislation, which is an encouraging trend showing an attempt to move towards EU 
harmonisation of regulatory requirements. 
 
EN 33   EN Table 5.1: Number of animals used in the production and qua lity control of products and devices for human medicine and 
dentistry and for veterinary medicine 
Regulatory requirements versus species 
Data of 2008 * 
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 
legislation 5.6. Any 
combination of 
5.2/ 5.3/ 5.4/ 
5.5 5.7. No 
regulatory 
requirements 5.8. Total 
1.a. Mice (Mus musculus) 33233 359722 371 21567 569279 43303 1027475 
1.b. Rats (Rattus norvegicus) 5107 86403 405 16406 105741 5319 219381 
1.c. Guinea-Pigs (Cavia porcellus) 2519 43916 0 6494 62550 5615 121094 
1.d. Hamsters (Mesocricetus ) 0 8916 0 358 3613 2 12889 
1.e. Other Rodents (other Rodentia) 0 0 0 0 30 0 30 
1.f. Rabbits (Oryctolagus cuniculus) 851 107271 0 1077 53039 20539 182777 
1.g. Cats (Felis catus) 43 614 0 8 58 10 733 
1.h. Dogs (Canis familiaris) 208 985 0 0 982 55 2230 
1.i. Ferrets (Mustela putorius furo) 0 2 0 0 522 48 572 
1.j. Other Carnivores (other Carnivore) 27 311 0 0 0 0 338 
1.k. Horses, donkeys and cross breds (Equidae) 307 225 0 0 164 2087 2783 
1.l. Pigs (Sus) 518 5436 0 91 2385 994 9424 
1.m. Goats (Capra) 68 27 0 3 10 11 119 
1.n. Sheep (Ovis) 805 1523 54 5 703 5079 8169 
1.o. Cattle (Bos) 139 2500 0 6 414 469 3528 
1.p. Prosimians (Prosimia) 0 0 0 0 0 0 0 
1.q. New World Monkeys (Ceboidea) 0 0 0 0 33 0 33 
1.r. Old World Monkeys (Cercopithecoidea) 0 0 0 0 231 0 231 
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0 
1.t. Other Mammals (other Mammalia) 13 50 0 0 0 28 91 
1.u. Quail (Coturnix coturnix) 0 0 0 0 0 0 0 
1.v. Other birds (other Aves) 1887 117540 60 1676 41194 7556 169913 
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) 2260 1430 0 0 406 24137 28233 
1.z. TOTAL 47985 736871 890 47691 841354 115252 1790043 
(*) France reporting for 2007 
Examples:  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 has issued the actual test method, guideline or protocol  
 5.4 - Spain is testing due to a Norwegian requirement  Example:  a test required by French legislation and carried out in Belgium according to an  
 5.5 – Poland 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 Swiss requirement (also an EC requirement)   entered into column 5.2 in the tables submitted by Belgium.  
    
Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech R ep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, 
Netherlands, Poland, Portugal, Romania, Slovak ia, Slovenia, Spain, Sweden, United Kingdom  
 2) Member Countries of Council of Europe (non-EC): Albania, Andorra , Croatia, Iceland, Liechtenstein, Moldova, Norway, Russia, San  Marino, Switzerland, 'the former Yugoslav Rep. of 
Macedonia' Turkey, Ukraine   
 
 
EN 34   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 requi rements for animals used in toxicological 
and other safety evaluations   
The consolidated table for the 27 Member States reporting data on animals used in 
toxicological and other safety ev aluations 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 
The use of animals for the regulatory requirem ents of different re gions in the area of 
toxicological or other safety ev aluation presented in Figure 6 follo ws a similar pattern to that 
of the use of animals used for regulatory pur poses in human medicine, dentistry and in 
veterinary medicine in different regions, presen ted in the Figure 5 in the previous chapter. 
As pointed out earlier, the number of animals us ed in toxicological or other safety evaluation 
represents 8,7% of the total number of animals used for experimental purposes in the EU. 
Figure 6
Percentages of animals used for regulatory requirements for toxicological and other 
safety evaluation  
8,55
23,96
0,10
2,58
49,66
15,150,00 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 regulatory requirements from several pieces of 
legislation covered almost half of the animals used in this area (50%). The testing required 
under EU legislation including the European Pharmacopoeia accounts for the second highest 
percentage in this area, namely 24%. 
The increase of the numbers of animals used fo r toxicological and other safety evaluations 
since the last report is relatively lo w and represents about 15,800 animals. 
 
EN 35   EN In comparison to the last report there is a net s light decrease in the proportion of animals used 
to simultaneously satisfy several pieces of regi onal legislation from 54% to nearly 50%.  
However, there is a substantial increase in the proportion of animals used for no regulatory 
requirements. In order to explain what is mean t by the term 'no regulatory requirements', some 
Member States gave as an example projects us ing in-house methods to verify the safety and 
efficacy of veterinary biologicals and medici nal products using animals, and carried out 
according to a company’s standards. The re sults may be accepted by that Member State 
national authority, although not  required by legislation. 
The testing carried out in 2008 to satisfy nationa l legislation specific to a single Member State 
showed a decrease of about 7,500 animals which represents roughly a 1% decrease compared 
to the last report. 
 
EN 36   EN  Table 6.1: Number of animals used in toxicological and other safety evaluations 
Regulatory requirements versus species 
Data of 2008* 
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 
legislation 6.6. Any 
combination of 
5.2/ 5.3/ 5.4/ 5.5 6.7. No 
regulatory 
requirements 6.8.Total 
1.a. Mice (Mus musculus) 35721 129353 752 5034 198942 28397 398199 
1.b. Rats (Rattus norvegicus) 17191 51343 89 11496 194371 20093 294583 
1.c. Guinea-Pigs (Cavia porcellus) 660 14723 84 390 15166 960 31983 
1.d. Hamsters (Mesocricetus ) 101 238 0 0 1106 135 1580 
1.e. Other Rodents (other Rodentia) 204 0 0 0 191 0 395 
1.f. Rabbits (Oryctolagus cuniculus) 1179 12694 2 1744 23426 942 39987 
1.g. Cats (Felis catus) 97 126 4 0 85 10 322 
1.h. Dogs (Canis familiaris) 626 1421 58 769 8023 180 11077 
1.i. Ferrets (Mustela putorius furo) 211 32 0 26 0 0 269 
1.j. Other Carnivores (other Carnivore) 296 0 0 0 0 0 296 
1.k. Horses, donkeys and cross breds 
(Equidae) 0 0 0 0 1 21 22 
1.l. Pigs (Sus) 172 1177 8 181 6102 425 8065 
1.m. Goats (Capra) 29 0 0 0 14 0 43 
1.n. Sheep (Ovis) 2 75 0 0 322 10 409 
1.o. Cattle (Bos) 10 226 0 44 173 0 453 
1.p. Prosimians (Prosimia) 0 543 0 0 0 0 543 
1.q. New World Monkeys (Ceboidea) 0 0 0 0 246 24 270 
1.r. Old World Monkeys (Cercopithecoidea) 0 265 0 732 4599 98 5694 
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0 
1.t. Other Mammals (other Mammalia) 0 0 0 0 0 0 0 
1.u. Quail (Coturnix coturnix) 24 680 0 0 1466 0 2170 
1.v. Other birds (other Aves) 10 7406 0 5000 36017 2798 51231 
1.w. Reptiles (Reptilia) 0 0 0 0 0 0 0 
1.x. Amphibians (Amphibia) 0 0 0 0 179 112 291 
1.y. Fish (Pisces) 32582 29413 0 1517 27071 103688 194271 
1.z. TOTAL 89115 249715 997 26933 517500 157893 1042153 
(*)France is reporting for 2007 
Examples:  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 Norwegian requirement  Example:  a test required by French legislation and carried out in Belgium according to an  
 6.5 – Poland 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 Swiss requirement (also an EC requirement)   entered into column 6.2 in the tables submitted by Belgium.  
    
Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech R ep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, 
Netherlands, Poland, Portugal, Romania, Slovak ia, Slovenia, Spain, Sweden, United Kingdom  
 2) Member Countries of Council of Europe (non-EC): Albania, Andorra , Croatia, Iceland, Liechtenstein, Moldova, Norway, Russia, San  Marino, Switzerland, 'the former Yugoslav Rep. of 
Macedonia' Turkey, Ukraine   
 
EN 37   EN III.8. Results of EU Table 7: Animals used in toxicity test s 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 27 Member States reporting on animals used in toxicity tests for 
the purpose of toxicological and ot her safety evaluations of produc ts (EU Table 7) is presented 
in Table 7.1 at the e nd 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 ( carcinogenicity, mutagenicity 
and toxicity to reproduction) effects in Table 7.2. A graph showing the percentage of animals 
used per toxicity test groups in 2008 is presented in Figure 7. 
Figure 7
Percentages of animals used in toxicity tests for toxicological
 and other safety evaluation
44,99
4,61
9,88
4,58
9,13
2,41
24,400,00 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 the previous chapter, the numb er of animals used in toxicological and other 
safety evaluations represents 8,7% of the to tal number of animals used for experimental 
purposes. 
In Figure 7 the largest percenta ge (almost 45%) of use of animals in toxicological and other 
safety evaluations is due to acute and sub-acute  toxicity tests. Also taking into account sub-
chronic and chronic toxicity, the percentage of animals used in short and long term systemic 
toxicity testing accounts for 55% in this area.  
13,7% of animals were used for testing carc inogenicity, mutagenicity and toxicity to 
reproduction. Another important cate gory of use of animals in 2008 is  for 'other tests' with 24%. 
Breaking down further the category 'other', Member  States reported testing in areas such as 
biological screening for pharmaceutical, health care and veterinary products. This includes 
neurotoxicity, toxicokinetics, tes ting of biological evaluation of medical devices: Intracutaneous 
testing of reactivity in rabbits, studies into the penetration of  nanoparticles through tissue and 
 
EN 38   EN their biocompatibility, studies into  the evaluation of sensitization po tential of dyestuffs used in 
the textile industry and pharmacological  studies included in  safety tests. 
By looking both in numbers and relative percenta ges of use of animals in comparison to the 
previous reports there are two noticeable changes: 
There is a continuous increase ove r the last three reports of th e proportion of animals used for 
acute and sub-acute tests, ranging from 36% - 42%  to almost 45% respec tively. This represents 
in animal numbers an increase of more than 37, 000 animals since the last report. Member States 
attributed the increase in part  to several phases in new product development and new legislation, 
for example requiring that all generi c substances should be tested.  
On the other hand one can observe a steady decreas e over the last three reports of the animals 
used for reproductive toxicity  testing from: 12% to 10% a nd to 9% respectively. This 
demonstrates a saving since the 2005 report of 8,650 animals. 
A general decrease in the number of animals us ed for regulatory toxicological evaluation could 
be attributed to the use of alternative met hods according to some Member States. However, 
others have suggested that replacement methods  have a much greater impact on research and 
development than on regulatory requirements.  
 
EN 39   EN Table 7.1: Number of animals used in toxicological and other safety evaluations 
Type of tests versus species 
 
Data of 2008*  
7.1. Species 7.2. Acute and sub-acute toxicity 
testing methods (including limit test) 7.3. 
Skin 
irritation 7.4. 
Skin 
sensitis
ation 7.5. Eye 
irritation 7.6. Sub- 
chronic 
and 
chronic 
toxicity 7.7. 
Carcino- 
genicity 7.8. 
Develop
- mental 
toxicity 7.9. 
Muta- 
genicity 7.10. 
Repro-
ductive 
toxicity 7.11. 
Toxicity 
to 
aquatic 
vertebra
-tes not 
included 
in other 
columns 7.12. 
Other 7.13. 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2. 
Other 
lethal 
methods 7.2.3. Non 
lethal 
clinical 
signs 
methods                       
1.a. Mice (Mus musculus) 87440 87455 46654 926 16742 30 27173 10375 3744 12858 2759 200 101843 398199 
1.b. Rats (Rattus norvegicus) 7060 12651 74924 768 1465 78 54915 10219 20263 14043 51314 26 46957 294683 
1.c. Guinea-Pigs (Cavia porcellus) 1000 303 3363 140 20198 6 618 0 120 0 101 7 6027 31883 
1.d. Hamsters (Mesocricetus ) 16 0 343 22 0 0 310 0 0 21 0 0 868 1580 
1.e. Other Rodents (other Rodentia) 27 0 0 0 0 0 204 0 0 0 0 0 164 395 
1.f. Rabbits (Oryctolagus cuniculus) 110 38 5875 4200 32 2105 1240 0 6047 0 5349 7 14984 39987 
1.g. Cats (Felis catus) 0 0 24 0 0 0 62 0 0 0 0 0 236 322 
1.h. Dogs (Canis familiaris) 15 339 4637 0 0 0 4582 0 0 0 20 0 1484 11077 
1.i. Ferrets (Mustela putorius furo) 0 0 211 0 0 0 0 0 0 0 0 0 58 269 
1.j. Other Carnivores (other 
Carnivore) 0 0 0 0 0 0 0 0 0 0 0 0 296 296 
1.k. Horses, donkeys and cross breds 
(Equidae) 0 0 0 0 0 0 0 0 0 0 0 0 22 22 
1.l. Pigs (Sus) 0 11 535 115 0 0 937 0 0 0 112 0 6355 8065 
1.m. Goats (Capra) 0 0 0 0 0 0 0 0 0 0 0 0 43 43 
1.n. Sheep (Ovis) 0 0 36 0 0 0 34 0 0 0 0 0 339 409 
1.o. Cattle (Bos) 0 0 60 0 0 0 12 0 0 0 22 0 359 453 
1.p. Prosimians (Prosimia) 0 0 261 0 0 0 143 0 0 0 0 0 139 543 
1.q. New World Monkeys (Ceboidea) 0 0 65 0 0 0 71 0 64 0 0 0 70 270 
1.r. Old World Monkeys 
(Cercopithecoidea) 18 0 1735 0 0 0 2861 0 176 0 58 0 846 5694 
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 0 0 
1.u. Quail (Coturnix coturnix) 819 241 0 0 0 0 0 0 0 0 176 0 934 2170 
1.v. Other birds (other Aves) 456 135 5937 1020 0 65 0 0 0 0 108 0 43510 51231 
1.w. Reptiles (Reptilia) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
1.x. Amphibians (Amphibia) 0 0 0 0 0 0 108 0 4 0 0 0 179 291 
1.y. Fish (Pisces) 50983 70000 5110 119 0 0 9735 213 868 0 3796 24857 28590 194271 
1.z. TOTAL 147944 171173 149770 7310 38437 2284 103005 20807 31286 26922 63815 25097 254303 1042153 
(*) France reporting for 2007  
 
EN 40   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 
carcinogenicity Reproductive 
and 
developmental 
toxicity Toxicity to 
aquatic 
vertebrates not 
included in 
other columns other Total  
1.a. Mice (Mus musculus) 221549 17698 27173 23233 6503 200 101843 398199 
1.b. Rats (Rattus norvegicus) 94635 2311 54915 24262 71577 26 46957 294683 
1.c. Guinea-Pigs (Cavia porcellus) 4666 20344 618 0 221 7 6027 31883 
1.d. Hamsters (Mesocricetus ) 359 22 310 21 0 0 868 1580 
1.e. Other Rodents (other Rodentia) 27 0 204 0 0 0 164 395 
1.f. Rabbits (Oryctolagus cuniculus) 6023 6337 1240 0 11396 7 14984 39987 
1.g. Cats (Felis catus) 24 0 62 0 0 0 236 322 
1.h. Dogs (Canis familiaris) 4991 0 4582 0 20 0 1484 11077 
1.i. Ferrets (Mustela putorius furo) 211 0 0 0 0 0 58 269 
1.j. Other Carnivores (other Carnivore) 0 0 0 0 0 0 296 296 
1.k. Horses, donkeys and cross breds 
(Equidae) 0 0 0 0 0 0 22 22 
1.l. Pigs (Sus) 546 115 937 0 112 0 6355 8065 
1.m. Goats (Capra) 0 0 0 0 0 0 43 43 
1.n. Sheep (Ovis) 36 0 34 0 0 0 339 409 
1.o. Cattle (Bos) 60 0 12 0 22 0 359 453 
1.p. Prosimians (Prosimia) 261 0 143 0 0 0 139 543 
1.q. New World Monkeys (Ceboidea) 65 0 71 0 64 0 70 270 
1.r. Old World Monkeys (Cercopithecoidea) 1753 0 2861 0 234 0 846 5694 
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0 0 
1.t. Other Mammals (other Mammalia) 0 0 0 0 0 0 0 0 
1.u. Quail (Coturnix coturnix) 1060 0 0 0 176 0 934 2170 
1.v. Other birds (other Aves) 6528 1085 0 0 108 0 43510 51231 
1.w. Reptiles (Reptilia) 0 0 0 0 0 0 0 0 
1.x. Amphibians (Amphibia) 0 0 108 0 4 0 179 291 
1.y. Fish (Pisces) 126093 119 9735 213 4664 24857 28590 194271 
1.z. TOTAL 468887 48031 103005 47729 95101 25097 254303 1042153 
 
EN 41   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 toxico logical 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 27 Member States reporting (EU table 8) is presented in 
table 8.1 of this report. The data in table 8 ha ve been subjected to a further quality criteria 
check developed by the Commissi on. The data provided by all Me mber States for this report 
were coherent.  
III.9.2. Treatment and interpretation of the data 
As pointed out earlier,  animals used in toxicological an d other safety evaluation represent 
8,7% of the total number of animals used for experimental purposes.  
In order to facilitate the interpretation of the results some types of toxi city testing have been 
grouped and the results can be fo und in consolidated table 8.2 at the end of this chapter. 
Figure 8 gives the proportion of animals used fo r toxicity and other safety evaluation by types 
of products. 
The treatment and interpretation of the data on an imals used for toxicity tests with regard to 
the type of products was done fo r the first time in the Fifth Statistical Report. However, 
because the graph in that repor t represented more the relative  importance of tests within a 
type of product rather than the proportion of animals used per t ype of test for the different 
products, the graph was modified accordingly for this report.  
0% 20% 40% 60% 80% 100%  Acute and sub-acute toxicity testing
methods (including limit test)
Irritation/sensitization tests
Sub- chronic and chronic toxicity
Carcinogenicity, Mutagenicity and Reprotox
Toxicity to aquatic v ertebrates not included
in other columns
OtherFigure 8
Proportion 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 animalconsumption
H) potential  or actual contaminents inthe general environment 
I)  other  toxicological or safetyevaluations
 
 
EN 42   EN Figure 8 shows that the majority of animals test ed in acute/sub-acute toxicity are intended for 
the purpose of human medicine, dentistry and veterinary medici ne. This is followed by tests 
carried out for other toxicological or safety ev aluation and then for agriculture and industrial 
products.  
Products intended for medicine, dentistry and veterinary medicine require the highest 
proportion of animals for the different types of tests i.e. approximately 50%. The next highest 
proportion is for ‘other’ toxicol ogical evaluations, above 20%, followed by animals used in 
tests for products for agricult ure and industry each above 7%.  
 
EN 43   EN Table 8.1: Number of animals used in toxicological and other safety evaluations 
Type of tests versus products 
Data of 2008*  
8.1. Products 8.2. Acute and sub-acute toxicity 
testing methods (including limit test) 8.3. Skin 
irritation 8.4. Skin 
sensitisa
tion 8.5. Eye 
irritation 8.6. Sub- 
chronic 
and 
chronic 
toxicity 8.7. 
Carcino- 
genicity 8.8. 
Develop
- mental 
toxicity 8.9. 
Muta- 
genicity 8.10. 
Repro-
ductive 
toxicity 8.11. 
Toxicity to 
aquatic 
vertebra-
tes not 
included 
in other 
columns 8.12. 
Other 8.13. 
Total 
  8.2.1. 
LD50, 
LC50 8.2.2. 
Other 
lethal 
methods 8.2.3. Non 
lethal 
clinical 
signs 
methods                       
8.a. Products/ subst ances or devices 
for human medicine and dentistry 
and for veterinary medicine  43643 85795 116481 3732 17719 506 62442 15063 12314 14286 37079 3917 116640 529617 
8.b. Products/ subs tances used or 
intended to be used mainly in 
agriculture 9066 4192 4987 724 4252 581 10089 3590 3120 2224 11578 11884 7860 74147 
8.c. Products/ substances used or intended to be used mainly in 
industry 5263 4832 12483 2368 11129 1001 8324 306 11475 6490 8863 2870 7022 82426 
8.d. Products/ subs tances used or 
intended to be used mainly in the 
household 617 1636 50 143 0 27 159 0 0 114 1016 0 520 4282 
8.e. Products/ subs tances used or 
intended to be used mainly as 
cosmetics or toiletries 822 207 98 87 699 54 0 0 0 0 0 0 0 1967 
8.f. Products/ subs tances used or 
intended to be used mainly as additives in food for human 
consumption 64 112 213 3 0 6 1421 649 3157 320 167 0 128 6240 
8.g. Products/ subs tances used or 
intended to be used mainly as 
additives in food for animal 
consumption 0 9142 177 0 0 0 100 0 0 0 0 80 44665 54164 
8.h. Potential or actual contaminants 
in the general environment which do 
not appear in other columns 37714 6243 2206 119 0 0 6294 213 85 1502 4111 4713 3410 66610 
8.i. Other toxicological or safety evaluations 10080 60404 7909 173 1797 94 8004 2625 319 2937 3176 1234 123948 222700 
8.j. TOTAL 107269 172563 144604 7349 35596 2269 96833 22446 30470 27873 65990 24698 304193 1042153 
(*) France reporting for 2007 
 
EN 44   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 carcinogenicity, 
Mutagenicity and Reprotox. Toxicity to 
aquatic vertebrates 
not 
included in other columns Other Total 
8.a. Products/ substanc es or devices for 
human medicine and dentistry and for 
veterinary medicine  245919 21957 62442 78742 3917 116640 529617
8.b. Products/ subst ances used or intended 
to be used mainly in agriculture 18245 5557 10089 20512 11884 7860 74147
8.c. Products/ subst ances used or intended 
to be used mainly in industry 22578 14498 8324 27134 2870 7022 82426
8.d. Products/ subst ances used or intended 
to be used mainly in the household 2303 170 159 1130 0 520 4282
8.e. Products/ subst ances used or intended 
to be used mainly as cosmetics or toiletries 1127 840 0 0 0 0 1967
8.f. Products/ substances  used or intended to 
be used mainly as additives in food for 
human consumption 389 9 1421 4293 0 128 6240
8.g. Products/ subst ances used or intended 
to be used mainly as additives in food for 
animal consumption 9319 0 100 0 80 44665 54164
8.h. Potential or actual contaminants in the general environment which do not appear in 
other columns 46163 119 6294 5911 4713 3410 66610
8.i. Other toxicological or safety evaluations 78393 2064 8004 9057 1234 123948 222700
8.j. TOTAL 424436 45214 96833 146779 24698 304193 1042153