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 Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union COM(2010) 511
Date: 2010-09-30
Institutions: European Commission
Subjects: EU statistics, animal experimentation, animal welfare, protection of animals, report, research method, scientific research

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EUROPEAN COMMISSION 

Brussels, 8.12.2010  
SEC(2010) 1107 final/2  
VOL A 

CORRIGENDUM: 
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 Number of Animals used for Experimental and 
other Scientific Purposes in the Member States of the European Union 
COM(2010) 511 

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TABLE OF CONTENTS 

I. 

II. 

INTRODUCTION ....................................................................................................... 4 

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 OVERVIEW 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 tests 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 

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I. 

INTRODUCTION 

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

The  first  two  statistical  reports  drafted  in  accordance  with  the  provisions  of  the  above 
mentioned directive which 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 absence of a consistent system of reporting the data. 
In 1997 an agreement was reached between the Commission and the competent authorities of 
the Member States to submit data for future reports using a format of eight harmonized tables. 
The third and fourth statistical reports published in 20034 and 20055 covering data collected in 
1999  and  2002  were  based  on  these  agreed  harmonized  tables.  This  allowed  a  much  wider 
interpretation  of  the  results  on  the  use  of  experimental  animals  in  the  EU.  In  spite  of  the 
progress made in the content of these two statistical reports, it ought to be stressed that there 
were  some  inconsistencies  in  the  data  submitted  by  the  Member  States  and  also  that  in  all 
cases except the report of 2003, one Member State collected data from another year. The Fifth 
Statistical  Report,  published  in  20076,  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  Member  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  Scientific  Purposes  in  the  Member  States  of  the 
European  Union.  The  report  summarizes  the  data  and  conclusions  presented  in  this  Staff 
Working Document. 

1 
2 
3 
4 
5 
6 

OJ L 358, 18.12.1986, p.1. 
COM (94) 195 final 
COM (1999) 191 final 
COM (2003) 19 final 
COM (2005) 7 final 
COM (2007) 675 final 

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II. 

DATA SUBMITTED AND 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  certain  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 purposes of experiments in EU table 2. Thus, the 
totals of the Tables 1 and 2 should be identical. 

–  The second relationship concerns column 2.6 of EU table 2 'animals used for toxicological 
and other safety evaluation' which is broken down into types of products/endpoints in EU 
table 3; into Regulatory requirements in EU table 6; and into types of toxicological tests in 
EU table 7. Therefore, the total of column 2.6 must be equal to the totals of tables 3, 6, 7 
and in addition table 8 'type of tests versus products' respectively.  

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

the total of EU table 5.  

–  In the fourth relationship, the total of EU table 3 should be equal to the total of table 8.  

The last criterion has shown obvious weaknesses when tested on the tables provided by the 
Member States and has lead to include an additional 5th quality check criterion.  

–  Fifth: each individual total in the 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 fulfilled by the Member States. It 
is therefore considered that the data provided by the Member States 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 Directive 86/609/EEC, to submit 
to  the  Commission  the  statistical  data  on  the  animals  used  for  experimental  and  other 
scientific purposes. The data for this report covers the year 2008 with the exception of France 
which provided data from 2007.  

Council  Resolution  86/C331/02  of  the  representatives  of  the  Governments  of  the  Member 
States  of  the  European  Communities,  meeting  within  the  Council  of  24  November  1986 
regarding  the  protection  of  animals  used  for  experimental  and  other  scientific  purposes7 
allows the use of animals in experiments for education and training, but where the purposes of 
such  experiments  are  not  covered  by  the  Directive,  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. 

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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 providing a comprehensive overview on the numbers of 
animals used for various experimental purposes in the Community in 2008. The purposes of 
the use of animals have been analysed, and some of these purposes have been broken down 
further  into  more  precise  parameters.  It  also  considers  different  legislative  requirements 
regarding  the  use  of  experimental  animals  and  the  type  of  testing  carried  out  on  different 
species.  

As the two  newest  Member States, Bulgaria and Romania, have submitted data for the first 
time, it is in principle not possible to draw accurate quantitative conclusions on the evolution 
of the use of animals for experimental purposes in the EU by comparing data with those of the 
previous reports. However, as their total use amounts to less than 1% of the total number of 
animals  used  in  2008,  some  comparisons  in  trends  have  been  attempted,  and  significant 
changes in use have been highlighted in the report.  

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

In the EU, the total number of animals used for experimental and other scientific purposes in 
2008  in  the  Member  States  amounts  to  just  over  12  million  (with  data  from  France  from 
2007).  

As  in  previous  reports  rodents  together  with  rabbits  represent  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 group 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.  

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II.3. 

Structure of the Report 

The report is divided into two parts: 

A  A global compilation and overview for the European Union of the statistical data of the 
Member States for 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 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  results  of  the  Report  of  2005,  for  which  France  submitted  statistical  data  for 
2004,  the  data  analysed  for  this  Report  includes  statistical  data  from  the  year  2007  from 
France.  Therefore,  the  totals  used  in  this  report  are  a  mixture  of  years.  Comparisons  were 
nevertheless made on this basis since no other data were available. 

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

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

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PART A: COMPILATION AND OVERVIEW OF THE DATA 
OF 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 relates to the place of origin of the animals 
used for experimental or other scientific purposes.  

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

Table  1.1  of  this  report  presents  the  consolidated  data  on  the  number  of  animals  used  for 
experimental  purposes,  by  species,  submitted  by  27  Member  States.  Whereas  in  previous 
years Malta had not used animals for scientific purposes, in 2008 this country 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  number  of  animals  used  in  the  new  Member  States 
who  joined  the  EU  in  2008  (Bulgaria  and  Romania)  represents  not  even  1,0%  of  the  total 
number of animals used in the EU 27.  

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

In order to present an overall evaluation and subsequently a graphical analysis, animal species 
were grouped. The result of this exercise is presented in Table 1.2 at the end 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. 

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

Artio+Perissodactyla 
1,39%

Carnivores 
0,26%

Prosimians+monkeys+a
pes 0,08%

Birds 6,38%

Cold-blooded animals 
9,62%

Rabbits 2,78%

Other rodents 0,60%

Guinea-Pigs 1,84%

Rats 17,70%

Other Mammals 
0,05%

Mice 59,30%

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  represented  by  cold-blooded  animals  namely  reptiles, 
amphibians and fish at 9,6%. 

Birds is the next highest animal group used for experimental 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  where  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  trends  by  comparing  changes  in  proportions  of 
use, expressed as a percentage. 

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Comparison  between  proportions  of  classes  of  animals  used  in  1996,  1999,  2002,  2005 
and 2008 

Class of species 

% Rodents-rabbits 
% Cold-blooded animals 
% Birds 
% Artio and Perissodactyla 

1996(*) 
81,3 
12,9 

1999 
86,9 
6,6 
4,7 
1,2 

2002(**) 
78,0 
15,4 
5 
1,2 

2005(***) 
77,5 
15, 
5,4 
1,1 

2008(****) 
82,2 
9,6 
6,4 
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 and 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 group of horses, donkeys and cross-bred animals 
(artiodactyla) and pigs, goats, sheep and cattle (perissodactyla) fluctuates at around 1%. 

Contrary  to  what  would  have  been  expected,  the  effect  of  the  inclusion  of  the  data  of  new 
Member States since 2005 i.e. Bulgaria and Romania, 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 species, 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) 

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Table 1.0 : Changes in species number and proportion between 2005 and 2008 

Species 

Number of 
animals 
in EU 25  

2005 

Mice (Mus musculus) 

6430346 

Number 
of 
animals 
in EU 27 

2008 
7122188 

Change 
since 
2005 

% 
change 
by 
species 

Change 
since 
2005 

Rats (Rattus norvegicus) 

2336032 

2121727 

-214305 

-223989 

2112043 

691842 

630992 

10,76

-9,17

Guinea-Pigs (Cavia 

257307 

220985 

-36322 

-14,12

-46774 

210533 

-18,18 

Hamsters (Mesocricetus ) 

Other Rodents (other 

31535 

64474 

32739 

39506 

1204 

3,82

759 

-24968 

-38,73

-24968 

32294 

39506 

Number of 
animals 
EU 25  
2008 
excl. 
RO,BG 
7061338 

% 
change 
by 
species  

9,81 

-9,59 

1.a 

1.b 

1.c 
porcellus) 
1.d 

1.e 
Rodentia) 
1.f 
cuniculus) 
1.g 

Rabbits (Oryctolagus 

Cats (Felis catus) 

1.h 

Dogs (Canis familiaris) 

1.i 
furo) 
1.j 

Ferrets (Mustela putorius 

Other Carnivores 

Horses, donkeys and cross 

1.k 
breds (Equidae) 
1.l 

Pigs (Sus) 

1.m 

Goats (Capra) 

1.n 

1.o 

1.p 

Sheep (Ovis) 

Cattle (Bos) 

Prosimians (Prosimia) 

New World Monkeys 

1.q 
(Ceboidea) 
-1.r 
(Cercopithecoidea) 
1.s 

Old World Monkeys 

Apes (Hominoidea) 

Other Mammals (other 

1.t 
Mammalia) 
1.u 

Quail (Coturnix coturnix) 

1.v 

1.w 

1.x 

1.y 

1.z 

Reptiles (Reptilia) 

Amphibians (Amphibia) 

Fish (Pisces) 

TOTAL 

312681 

333213 

20532 

3898 

24119 

2690 

8711 

5312 

66305 

2146 

30021 

36271 

677 

1564 

8208 

4088 

21315 

3208 

2853 

5976 

92813 

3840 

30190 

33952 

1261 

904 

7404 

190 

-2804 

518 

-5858 

664 

26508 

1694 

169 

-2319 

584 

-660 

-804 

6,57

4,87

-11,63

19,26

-67,25

12,50

39,98

78,94

0,56

-6,39

86,26

-42,20

-9,80

0 

0 

0 

0,00 

17514 

330195 

179 

-2819 

518 

-5858 

633 

26369 

1614 

-212 

-2448 

584 

-660 

-804 

0 

371 

4077 

21300 

3208 

2853 

5945 

92674 

3760 

29809 

33823 

1261 

904 

7404 

5704 

9617 

Other birds (other Aves) 

649813 

754485 

104672 

0 

0,00 

9950 

9246 

5704 

9626 

380 

-4246 

-42,67

-4246 

2477 

74620 

4101 

61789 

1624 

-12831 

1749178 

1087155 

-662023 

4,11

16,11

65,56

-17,20

-37,85

101999 

751812 

1624 

-17631 

4101 

56989 

-662073 

1087105 

12117581 

12001022 

-116559 

-0,96

-209326 

11908255 

2,41 

-38,73 

5,60 

4,59 

-11,69 

19,26 

-67,25 

11,92 

39,77 

75,21 

-0,71 

-6,75 

86,26 

-42,20 

-9,80 

-42,67 

4,01 

15,70 

65,56 

-23,63 

-37,85 

-1,73 

There is an increase in the number of mice used since 2005 of 691,842 which is 10,7% of the 
total  number  of  mice  used  in  2005  and  a  decrease  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  increased  by  between  40%  – 
86,3%.

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The total number of rats, guinea-pigs, other rodents, dogs, cattle and other mammals as well 
as amphibians and fish used has decreased substantially since the last report. When expressed 
in percentages these decreases range from more than 40 to around 9%.  

The  largest  percentile  change  has,  however,  been  noted  in  the  decrease  of  the  use  of  other 
carnivores.  However,  these  species  are  not  used  in  great  numbers  (from  8,711  to  2,853). 
There is also a large decrease of 42,7% in the total number 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. Prosimian 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 percentage 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 experimental or other scientific 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  zoological  and  ecological  studies  e.g.  foxes, 
badgers, seals, otters and fitchew. 

Other mammals: boars, bats and shrews, llamas, moles, European bison and red deer. 

Other birds: mainly Japanese Quail (coturnix japonica) and bob-white quail, poultry species, 
and zebra finches, canaries, parakeets, parrots 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 proportional changes between the species.  

Romania has little effect on the proportional changes between the species ranging from no 
change to very marginal variations per species. However, there is a net decrease of guinea 
pigs – 4%, and 10% for amphibians, when data from Bulgaria and Romania are excluded.

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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 

177544 

480681

16265

2114 

54776 

168164 

28754

1561809

1314493

19786

158799

392773

390853

4367

a. Mice 
b. Rats  
c. Guinea-Pigs 
d. Hamsters 
e.Other Rodents  
f. Rabbits 
g. Cats  
h. Dogs 
i. Ferrets 
j.Other 

Carnivores  

k. horses, 

donkeys & 
cross-breeds 

l. Pigs 
m. Goats 
n. Sheep 
o. Cattle  
p. Prosimians 
q.N W Monkeys  
r.O W Monkeys 
s. Apes 
.t.Other 

Mammals  

u. Quail 
v. Other birds 
w. Reptiles  
x. Amphibians 
y. Fish 
z.TOTAL 

108580

36554

2124
1055  

42025
78
788

324

0  

4513

3845

182

813
11
15

0

0 

0 

0 

0 
0 
0 

0 

21531 

75850 

5268

1902 

251 
1233 

6304 
45 
552 

122 
45 

5343 

4 
1760 

2931 
154 
271 

117 
101 

22

120
0

630

0  
0

0  
0

78446

26058

215

302
3142

814

54

761

9928 

3284 

693 
47 

18761 
2 
41 

14 
0 

47 

5086 

2969

39 

142 
574 

0 

0 

0 

0 

0 

195

356
657

0

0

41

0

151  

14 

431

137  

80  

250  
126  

0

0

0

0

0

1367 

17151

1477  

17 

277 
2579 

374  

2388
28386

4800  
50  

0 

0 

0 

0 

0 

2013 

174 

1148 
799 

0 

0 

80 

0 

6863 

107 

88 
939 

0 

0 

0 

0 

1774 

243 

0 

148722 

1012 

3016 
54836 

0 

2820 

221 

293 
31245 

0  

0

0  

0  

0  

0  

0  

819

571
300

84

5568

317

34
21078

46030

12063
3594

96427
1848
4131

800
0

652

8768

1159

3573
3206

718

233

1797

0

0

1548

156814

758

9451
20228

89375

9743

215
356  

8134
40
686

0  
0  

71224

11741

91

68

204
295
557

553000

230347

13875

717
1235  

9706
26
943

0
0  

6912 

2407 

3827

1194

32 

0 

48 
0 
0 

0 

93

0

199
0
0

0

50

44

237681

105780

123897

39811

44585

45824

6495

312
11966  

6571

152

29

3086

99

83  
230  

0  
520  

5171

6607

263

2205
0
0

0

543680

175325

12620

1262
251

19626
100
1046

287

5  

6942

9692

982

0
45

679
18
4

0

6062

3358
2439

7418
253
1244

472
10

35870

7061
8392  

97938
798
4450

45

0

1498
4
44

55
410  

584

0

1

12361

624

1193

224

3607  

80

531

4638
6252

543

305

1415

0

541  

1803

53986

192  

24

68
72

0

0

0

0

0

88

10815
67496

200
1200

456
4019

92  

200
93

0  

5  

1  

0  

41  

469  
462  

0

18

344

0

16

32

151  

13  

249

32554

582

32241  

108  

1182  
2077

23198

454  

2432  
13955  

0 

0 

0 

0 

0 

0

0

0

0

0

40

149

2562

529

6

14

90  

11729

11742

222

2

15121

22

229

3486
2236

0

73

82

0

300  

2217
7540

0  

0  

0  

0  

202

1246  

0

5100  

28
10

131
3

372

2386
1091  

0

0

0

0

9

0

8

517

0

28

138

90890

27391

160

1196

52104

5

9

0

0

0

0

21

120

696

121

870
23859

248  

1221  

704  

25941

3800  

71098

25

3280

430

100

0
0

20
0
0

0
0

0

0

0

0
0

0

0

0

0

0

0

0

0

0
0

0

0

0
0
0

0

0

0

0

0

0

600

694

10313

203112 

1212243 

7122188 

1675

53141 

343289 

2121727 

7

0
0

307
0
0

0
0

0

3

0

4
0

0

0

0

0

0

0

129

0

0
0

1766 

864 
2033 

1332 
149 
1982 

39 
53 

29250 

220985 

2851 
1958 

12009 
184 
4277 

978 
948 

32739 
39506 

333213 
4088 
21315 

3208 
2853 

423 

290 

5976 

1973 

5 

152 
1379 

0 

0 

35 

0 

263 

201 

3432 

170 

7255 

487 

9818 
4194 

0 

262 

3092 

0 

952 

92813 

3840 

30190 
33952 

1261 

904 

7404 

0 

5704 

0 

9626 

125077 

754485 

109 

4101 

641 
211459 

23316 
484045 

61789 
1087155 

220456 

725370

32581

2114 

300713 

297568 

34794

138600

2328380

2021782

28021

304922

112835

864318

9399 

5582

3830

501056

275888

50888

60186

897859

19260

12438

484604 

2266884 

12001022 

62

17  

378 

54 

0

37

40

144

46  

(*) France is reporting for 2007 

EN 

13 

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 
Rats  
Guinea-Pigs 
Hamsters + 
other rodents 
Rabbits  
Cold-blooded 
animals (1) 
Birds (2)  
Artio+perisso
dactyla (3) 
Carnivores  
Prosimians+
monkeys 
+apes  
Other 
mammals 

 TOTAL  

177544 

480681 

16265

2114

9928 

3284 
740 

108580 

36554 
3179 

18761 
2873 

42025 
31148 

1381 

5888 

17582 

4239 

57 
0 

1190 
41 

4513

3845
182

813
4850

1477

610

26
0

0

0
0

0
0

0

0

0
0

54776 

21531 

1902 
1484 

6304 
58864 

148722 

4512 

764 
80 

168164 

28754

75850 

5268

5343 
1764 

2931 
31759 

2820 

8051 

643 
0 

22
120

630
0

0

0

0
0

78446

26058

215
3444

814
21429

5568

1727

815
0

46030
15657

96427
30437

158362

17358

6779
2748

1561809

1314493

19786

158799

392773

390853

4367

89375

35870
15453

45
0

97938
78503

1498
1400

9743
571

8134
3367

71224

11741

91
68

553000

230347

13875
1952

204
23198

9706
16841

55789

24366

5713
2263

88

789

48
0

32567

1618

582

4843

32490

4625

726
6

852
0

969
362

6912 

2407 

3827 

1194 

32 
0 

48 
0 

0 

0 

0 
0 

93 
0 

199 
149 

40 

80 

0 
0 

3280

430

100
0

50

44

0
0

237681

123897

105780

6062
5797

45824

6495
12278

20
0

0
600

7418
24850

3086
27410

0

0

0
0

0

0

0
0

90890

20242

32491

22328

1979
155

833
0

39811

6571

152
29

99
3800

160

266

0
0

44585

543680

5171

6607
263

2205
0

1205

150

175325

12620
1513

19626
71802

52242

19060

0
0

1438
525

0 

151   

1774 

243   

84

0

541  

16

32

151  

0  

202

1246  

28

6942

9692

982
45

679
25

816

36

22
0

21

10313

203112 

1212243 

7122188 

1675

53141 

343289 

2121727 

7
0

307
0

129

7

0
0

0

1766 
2897 

29250 
4809 

220985 
72245 

1332 
212270 

12009 
507470 

333213 
1153045 

3633 

3932 

2223 
35 

125077 

22044 

764111 

166771 

6387 
3354 

31464 
9569 

263 

952 

5704 

220456 

725370 

32581

2114

300713 

297568 

34794

138600

2328380

2021782

28021

304922

112835

864318

9399 

5582 

3830

694

501056

275888

50888

60186

897859

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 

49,92

13,85

11,80

0,56

2,50
14,89

66,27 

80,53 

1,49 

5,04 

0,63 

4,50 

0,44 

0,34 

14,97 

5,79 
4,29 

8,51 
1,30 

Mice 
Rats  
Guinea-Pigs 
Hamsters + 
other rodents 
Rabbits  
Cold-blooded 
animals (1) 
Birds (2)  
Artio+perisso
dactyla (3) 
 Carnivores  
Prosimians+
monkeys+ 
apes  
 Other 
mammals 
 Mice 
 TOTAL  
FR(*) France reporting for 2007 

0,03 
0,00 

0,16 
0,01 

2,42 

2,67 

0,58 

0,00 

0,02 

100 

100 

4,53

1,87

0,08
0,00

0,00

100

100,00

18,22 

0,00

0,00

0,00

0,00
0,00

0,00

0,00

0,00
0,00

7,16 

0,63 

0,49 

2,10 
19,57 

49,46 

1,50 

0,25 
0,03 

56,51 

25,49 

1,80 

0,59 

0,98 
10,67 

0,95 

2,71 

0,22 
0,00 

82,64

15,14

0,06

0,34

1,81
0,00

0,00

0,00

0,00
0,00

56,60

18,80

0,16

2,48

0,59
15,46

4,02

1,25

0,59
0,00

67,08

16,87

1,98

0,67

4,14
1,31

6,80

0,75

0,29
0,12

65,02

19,33

1,77

0,76

70,61

15,58

0,16

0,00

4,84
3,88

2,76

1,21

0,28
0,11

5,35
5,00

0,31

2,82

0,17
0,00

52,08

29,31

3,20

0,19

2,67
1,10

10,68

0,53

0,24
0,00

63,12

10,41

0,08

0,06

0,18
20,56

0,52

4,29

0,76
0,00

63,98

7 3 , 5 4  6 8 , 5 6 

26,65

2 5 , 6 1  2 1 , 3 9 

1,61

0,23

1,12
1,95

3,76

0,54

0,11
0,04

0,34 

0,00 

0,51 
0,00 

0,00 

0,00 

0,00 
0,00 

1,67 

0,00 

3,57 
2,67 

0,72 

1,43 

0,00 
0,00 

85,64

11,23

2,61

0,00

7,20

6,34

0,00

0,00

0,52
0,00

0,00
86,46

0,00

0,00

0,00
0,00

0,00

0,00

0,00
0,00

47,44

21,11

1,21

1,16

1,48
4,96

44,91

16,61

2,35

4,45

1,12
9,94

18,14

4,04

11,78

8,09

0,39
0,03

0,30
0,00

78,23

12,91

0,30

0,06

0,19
7,47

0,31

0,52

0,00
0,00

74,08

8,59

10,98

0,44

3,66
0,00

2,00

0,25

0,00
0,00

60,55

19,53

1,41

0,17

2,19
8,00

5,82

2,12

0,16
0,06

36,04

50,32

5,10

0,23

3,53
0,13

4,24

0,19

0,11
0,00

82,92

13,47

0,06

0,00

2,47
0,00

1,04

0,06

0,00
0,00

41,91 

10,97 

0,36 

0,60 

0,27 
43,80 

0,75 

0,81 

0,46 
0,01 

53,48 

15,14 

1,29 

0,21 

0,53 
22,39 

5,52 

0,97 

0,28 
0,15 

59,35 

17,68 

1,84 

0,60 

2,78 
9,61 

6,37 

1,39 

0,26 
0,08 

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 

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 

(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 

14 

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 percentage of animals from the reported origin versus the species.  

Figure 1.2:  Origin of species 

100%

80%

60%

40%

20%

0%

e
c
M

i

s
t
a
R

s
r
e
t
s
m
a
H

s
t
i
b
b
a
R

s
t
a
C

s
g
o
D

s
t
e
r
r
e
F

i

s
g
P
-
a
e
n
u
G

i

Other countries

ETS 123 countries

EU countries

s
e
p
A

l
i

a
u
Q

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

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

l

i

s
n
a
m
s
o
r

i

P

The chart shows clearly that 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 

15 

   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 first time in 2005 the prosimians were all of EU 
origin  and  remain  so  for  this  report.  A  similar  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 

16 

   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 
breeding 
registered 
or 
establishments 
supplying 
within the reporting country 

1.4. Animals 
coming from 
elsewhere in the 
EC 

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

1.6. Animals coming 
from other origins 

1.7. Re-used 
animals 

1.a. Mice (Mus musculus) 

1.b. Rats (Rattus norvegicus) 

1.c. Guinea-Pigs (Cavia porcellus) 

1.d. Hamsters (Mesocricetus ) 

1.f. Rabbits (Oryctolagus cuniculus) 

1.g. Cats (Felis catus) 

1.h. Dogs (Canis familiaris) 

1.i. Ferrets (Mustela putorius furo) 

1.p. Prosimians (Prosimia) 

1.q. New World Monkeys (Ceboidea) 

1.r. Old World Monkeys (Cercopithecoidea) 

1.s. Apes (Hominoidea) 

1.u. Quail (Coturnix coturnix) 

1.z. TOTAL 

* France: data of 2007 

7122188
2121727
220985
32739
333213
4088
21315
3208
1261
904
7404
0
9626

9878658

6042205
1761785
161973
24999
315006
2306
12467
1847
718
816
3213
0
7824

8335159

900230
329385
56167
5476
14753
726
2885
442
543
83
850
0
1500

1313040

21382
9844
2051
1074
364
14
309
0
0
5
5
0
0

35048

158371
20713
792
1190
3087
1042
5654
919
0
0
3336
0
302

195406

3768 
3035 
962 
54 
15958 
1181 
4178 
64 
33 
346 
1509 
0 
0 

Note 1: Column 1.5 concerns only those member countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those 
countries has to be used when filling 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 

17 

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 experiments of the 27 Member States are presented 
in Table 2.1 at the end of this chapter. 

III.3.2.  Treatment and interpretation of the data  

Table  2.2  presents  the  results  of  the  consolidated  data  of  the  purposes  of  the  procedures 
carried out in the 27 Member States in 2008. In order to facilitate 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

Other 12,2%

Education and training 
1,7%

Diagnosis of disease 
1,6%

Toxicological and other 
safety evaluation 8,7%

Production and quality 
control veterinary 
medicine 4%

Production and quality 
control human medicine 
and dentistry  10,9%

Fundamental biology 
studies 38,1%

Research and develop 
human +veterin+dentist 
22,8%

More  than  60%  of  animals  were  used  in  research  and  development  for  human  medicine, 
veterinary medicine, dentistry and in fundamental biological studies. 

Production  and  quality  control  of  products  and  devices  in  human  medicine,  veterinary 
medicine and dentistry required the use of 14,9% of the total number of animals. 

Toxicological and other safety evaluation 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 such as virology, immunology for production of monoclonal and 
polyclonal  antibodies,  physiology  of  foetal-maternal  interaction  in  mouse  gene  transgensis, 

EN 

18 

   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 since 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  animal  numbers  the  decrease  is  from  3,746,028  to 
2,733,706). To be noted in particular is the significant reduction 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  purposes',  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 the highest number of animals for experimental 
purposes in the EU. 

The  number  of  animals  used  for  toxicological  and  other  safety  evaluation  has  remained 
virtually unchanged since the last report and amounts to 8,7% of the total number of animals 
used for experimental purposes in the EU. This represents 1,042,153 animals. 

In  general  the  number  of  animals  used  for  production  and  quality  control  of  devices  for 
medicine,  veterinary  medicine  and  dentistry  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 and 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 increase in use of experimental animals. 

Another Member State using a large number of rabbits for production and quality control of 
veterinary medicine indicated that the laboratory responsible for that increase had reported the 
data  in  the  wrong  column,  that  is,  they  should  have  been  reported  under  production  and 
quality  control  of  human  medicine  and  dentistry  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 other 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  attributed  to  the  new  research  possibilities  offered  by  the  transgenic 
species. These animal models are being used both 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 research, and for immunology and microbiology. 

There are several reasons for the increase in the use of pigs in ‘fundamental biological’ and 
also  in  ‘other  studies’.  One  Member  State  using  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 pigs relates to pig disease studies, including for 

EN 

19 

   EN 

 
example the observation of vaccine effectiveness. It was reported that the increase was also 
due  to  fundamental  research  on  pigs’  enzymes  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  ringing.  The  increase  of  the  number  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 

Mice  
Rats  
Other rodents 
Rabbits 
Carnivores 
Artio+perissodactyla 
Prosimians+monkeys+apes 
Other mammals  
Birds 
Cold-blooded animals 
TOTAL 

3080775 
595542 
44240 
17813 
4804 
55080 
1213 
5279 
292895 
477413 
4575054 

Research,
developm
ent and 
quality 
control of 
products 
and 
devices 
for human 
medicine 
and 
dentistry 
and for 
veterinary 
medicine 
2624856 
1060290 
195427 
212618 
11378 
56359 
1260 
177 
247618 
113766 
4523749 

Diagnosi
s of 
disease 

 Education 
and 
training 

Other 

Total 

Toxicologic
al and other 
safety 
evaluations 
(including 
safety 
evaluation 
of products) 

398199 
294683 
33858 
39987 
11964 
8996 
6507 
0 
53477 
194482 
1042153 

137578 
22997 
3145 
3376 
1360 
4620 
153 
12 
8415 
3651 
185307 

82606 
59412 
7826 
3326 
515 
13134 
10 
25 
11444 
29159 
207457 

798174 
88803 
8734 
56093 
1443 
28582 
426 
211 
150262 
334574 
1467302 

7122188
2121727
293230
333213
31464
166771
9569
5704
764111
1153045
12001022

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

The  highest  number  of  mice  and  rats  is  attributed  to  fundamental  biological  studies  and 
research, development and quality control of products and devices for medicine, dentistry and 
veterinary medicine. It is noteworthy that a high number of cold-blooded animals have been 
used for 'other purposes' as well as for 'biological studies of a fundamental nature'. 

One can observe a significant reduction in the use 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 

20 

   EN 

 
 
5
0
0
0
0
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1
0
0
0
0
0
0

1
5
0
0
0
0
0

2
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2
5
0
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0
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3
0
0
0
0
0
0

3
5
0
0
0
0
0

0

 Mice (Mus musculus)

 Rats (Rattus norvegicus)

Other rodents

Rabbits (Oryctolagus cuniculus)

Carnivors

Artio+perissodactyla

Prosimians+monkeys+apes

Other Mammals 

Birds

Cold-blooded animals

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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) 
1.b. Rats (Rattus norvegicus) 
1.c. Guinea-Pigs (Cavia porcellus) 
1.d. Hamsters (Mesocricetus ) 
1.e. Other Rodents (other Rodentia) 
1.f. Rabbits (Oryctolagus cuniculus) 
1.g. Cats (Felis catus) 
1.h. Dogs (Canis familiaris) 
1.i. Ferrets (Mustela putorius furo) 
1.j. Other Carnivores (other Carnivora) 
1.k. Horses, donkeys and cross breds 
(Equidae) 
1.l. Pigs (Sus) 
1.m. Goats (Capra) 
1.n. Sheep (Ovis) 
1.o. Cattle (Bos) 
1.p. Prosimians (Prosimia) 
1.q. New World Monkeys (Ceboidea) 
1.r. Old World Monkeys 
(Cercopithecoidea) 
1.s. Apes (Hominoidea) 
1.t. Other Mammals (other Mammalia) 
1.u. Quail (Coturnix coturnix) 
1.v. Other birds (other Aves) 
1.w. Reptiles (Reptilia) 
1.x. Amphibians (Amphibia) 
1.y. Fish (Pisces) 
1.z. TOTAL 

(*) France is reporting for 2007 

3080775 
595542 
10632 
6994 
26614 
17813 
560 
1814 
551 
1879 
1402 

23531 
1098 
9727 
19322 
568 
235 
410 

0 
5279 
5520 
287375 
3781 
32780 
440852 
4575054 

EN 

1597381 
840909 
44344 
8041 
9006 
29764 
1738 
4405 
1287 
75 
728 

22799 
721 
4098 
3990 
0 
235 
761 

0 
86 
57 
77748 
94 
1914 
83525 
2733706 

856048 
181140 
103852 
376 
30 
131031 
57 
157 
564 
0 
224 

423 
93 
6020 
214 
0 
33 
231 

0 
28 
0 
10593 
0 
0 
20418 
1311532 

22 

171427 
38241 
17265 
12513 
0 
51823 
679 
2070 
8 
338 
2559 

9001 
26 
2149 
3314 
0 
0 
0 

0 
63 
0 
159220 
0 
0 
7815 
478511 

398199 
294683 
31883 
1580 
395 
39987 
322 
11077 
269 
296 
22 

8065 
43 
409 
457 
543 
270 
5694 

0 
0 
2170 
51307 
0 
291 
194191 
1042153 

137578 
22997 
1940 
278 
927 
3376 
124 
1111 
45 
80 
239 

1452 
90 
1616 
1223 
150 
0 
3 

0 
12 
9 
8406 
0 
202 
3449 
185307 

82606 
59412 
5804 
520 
1502 
3326 
97 
362 
56 
0 
489 

8134 
422 
1243 
2846 
0 
0 
10 

0 
25 
1575 
9869 
147 
12213 
16799 
207457 

798174 
88803 
5265 
2437 
1032 
56093 
514 
316 
428 
185 
313 

19408 
1347 
4928 
2586 
0 
131 
295 

7122188 
2121727 
220985 
32739 
39506 
333213 
4091 
21312 
3208 
2853 
5976 

92813 
3840 
30190 
33952 
1261 
904 
7404 

0 
211 
295 
149967 
79 
14389 
320106 
1467302 

0 
5704 
9626 
754485 
4101 
61789 
1087155 
12001022 

EN 

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

product/endpoint 

III.4.1.  The data on toxicological and safety evaluation by type of product/endpoint 

The consolidated table giving the number of animals used for toxicological and other safety 
evaluation of products (EU Table 3) in 27 Member States in 2008 is presented in Table 3.1 at 
the  end  of  this  chapter.  In  table  3.1  the  number  of  animals  used  for  toxicological  or  other 
safety evaluation is broken down into types of products for which testing was required. 

The percentage of the number of animals used for different types of product 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 

3.9   Potential  or actual 
contaminents in the 
general environment which 
do not appear in other 
columns
6,32

3.10    Other  toxicological 
or safety evaluations
21,45%

3.2    Products/ 
substances or devices for 
human medicine and 
dentistry and for veterinary 
medicine
50,81%

3.8    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%

3.4   Products/ 
substances used or 
intended to be used mainly 
in industry
7,91

3.3     Products/ 
substances used or 
intended to be used mainly 
in agriculture
7,11%

The  number  of  animals  used  for  toxicological  and  other  safety  evaluation  for  different 
products or environmental test schemes amounts 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 evaluations are split up according to the type of sector for which 
they are intended. The percentage of animals used 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%) when compared to the other product groups. 

EN 

23 

   EN 

 
 
Products  or  devices  used  for  human  medicine,  veterinary  medicine  and  dentistry  represents 
50,8% of the animals used for toxicological or other safety evaluations. 

The  group  of  products/substances  falling  under  the  scrutiny  of  Member  States  authorities 
concerned  with  safety  of  health  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  animals  used  for  toxicological  tests  for  products 
intended for industry, for agriculture and for potential 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 number of animals used for testing of products for 
cosmetics and toiletries ranging from 5,500 to just below 2,000 (a 65% drop). This change has 
to be seen in light of the legal requirement to phase out animal testing for cosmetics in the EU 
where a ban on testing has been applicable since 2009 for all human health effects with the 
exception of three toxicological end-points: repeated-dose toxicity, reproductive 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  significant  increase  since  2005  in  the  number  of  animals  used  for 
tests for additives in food for animal consumption (from 34,225 to 54,164). This may reflect 
the  animal  feed  sanitary  concerns  expressed  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 the 2005 report, there is a significant increase in 
the  number  of  animals  used  for  ‘other’  toxicological  or  safety  evaluation  (ranging  from 
around 180,000 to about 220,000). Member States reported that this particular use of animals 
concerned new methods and tests, such as tests on transmission of microcystins on embryonic 
membrane,  bioassays,  toxicity  evaluation  for  humans  via  the  environment,  and  control  of 
safety of toys. 

EN 

24 

   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 

3.11.Total 

3.10.Other 
toxicological 
or safety 
evaluations 

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

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

(*) France reporting for 2007 

188227 
187283 
23152 
1559 
0 
30516 
312 
9888 
269 
296 
22 

3169 
21 
408 
409 
543 
200 
5121 
0 
0 
64 
8838 
0 
179 
69021 
529497 

10129 
31421 
2830 
0 
164 
2696 
0 
340 
0 
0 
0 

90 
14 
0 
4 
0 
0 
0 
0 
210 
2110 
2116 
0 
108 
21915 
74147 

20249 
41562 
3679 
21 
0 
4453 
0 
16 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
30 
0 
0 
12416 
82426 

1922 
1709 
0 
0 
0 
50 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
601 
4282 

880 
174 
38 
0 
0 
153 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
722 
1967 

2818 
2764 
24 
0 
0 
11 
0 
0 
0 
0 
0 

100 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
523 
6240 

1680 
303 
7 
0 
0 
7 
0 
0 
0 
0 
0 

4584 
0 
0 
0 
0 
0 
0 
0 
0 
0 
39553 
0 
0 
8030 
54164 

9433 
2932 
0 
0 
204 
12 
0 
0 
0 
0 
0 

64 
8 
0 
0 
0 
0 
0 
0 
0 
0 
97 
0 
0 
53062 
65812 

162919 
26496 
2192 
0 
27 
2127 
10 
833 
0 
0 
0 

66 
0 
1 
44 
0 
70 
573 
0 
0 
0 
320 
0 
4 
27936 
223618 

EN 

25 

398257 
294644 
31922 
1580 
395 
40025 
322 
11077 
269 
296 
22 

8073 
43 
409 
457 
543 
270 
5694 
0 
210 
2174 
50954 
0 
291 
194226 
1042153 

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 Table 4.1 at the end of this chapter. 

III.5.2.  Treatment and interpretation of the data 

Table 4.1 gives the number of animals used per type of studies on diseases.  

In  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%)  the  total  number  of 
animals used for experimental purposes in the EU. 

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

The proportion of animals used for studies of human 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 cardiovascular 
diseases
6,4%

Specific to animal 
diseases
9,7%

Other human diseases 
47,8%

Human nervous and 
mental disorders 
22,6%

Human cancer 
(excluding evaluations 
of carcino hazards ) 
13,5%

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 particular, a significant change 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 decrease, the use of mice increased substantially 
in 2008. Around 30% of the increase (about 681,000) can be attributed to different studies of 
diseases (see also observations under chapter III.3.3). 

EN 

26 

   EN 

 
 
Some Member States confirmed that 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  development  of  products  for  human  and  veterinary 
medicine and even production and control process 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 fundamental 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 necessarily 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 diseases studies linked to the increase in the number of birds, 
Member States reported studies on bird flu, Gumboro disease and bronchitis including studies 
on quality and safety of vaccines. 

EN 

27 

   EN 

 
Table 4.1: Number of animals used in experiments for studies on human and animal diseases  
Main category of diseases versus species   
Data of 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) 
1.b.  Rats (Rattus norvegicus) 
1.c.  Guinea-Pigs (Cavia porcellus) 
1.d.  Hamsters (Mesocricetus ) 
1.e.  Other Rodents (other Rodentia) 
1.f.  Rabbits (Oryctolagus cuniculus) 
1.g.  Cats (Felis catus) 
1.h.  Dogs (Canis familiaris) 
1.i.  Ferrets (Mustela putorius furo) 
1.j.  Other Carnivores (other Carnivore) 
1.k.  Horses, donkeys and cross breds 
(Equidae) 
1.l.  Pigs (Sus) 
1.m.  Goats (Capra) 
1.n.  Sheep (Ovis) 
1.o.  Cattle (Bos) 
1.p.  Prosimians (Prosimia) 
1.q.  New World Monkeys (Ceboidea) 
1.r.  Old World Monkeys (Cercopithecoidea) 
1.s.  Apes (Hominoidea) 
1.t.  Other Mammals (other Mammalia) 
1.u.  Quail (Coturnix coturnix) 
1.v.  Other birds (other Aves) 
1.w.  Reptiles (Reptilia) 
1.x.  Amphibians (Amphibia) 
1.y.  Fish (Pisces) 
1.z.  TOTAL 

France reporting for 2007 

249486 
125904 
2856 
1940 
673 
5373 
14 
1233 
20 
72 
3 

4638 
170 
597 
243 
0 
7 
111 
0 
29 
0 
4769 
0 
362 
5841 
404341 

858612 
489630 
5004 
2986 
6737 
1386 
169 
207 
184 
0 
0 

417 
39 
601 
36 
40 
101 
261 
0 
55 
400 
4563 
90 
603 
57964 
1430085 

803038 
43336 
262 
791 
239 
1781 
0 
144 
0 
0 
0 

100 
87 
24 
0 
0 
0 
6 
0 
5 
0 
47 
0 
2886 
2458 
855204 

1883499 
600979 
47326 
6751 
5093 
28138 
126 
4544 
2153 
468 
154 

9589 
478 
8065 
2860 
311 
419 
3173 
0 
887 
177 
21365 
0 
10852 
381109 
3018516 

292772
16909
3252
3104
4617
6983
1930
3810
105
411
1614

17299
1014
6833
13756
370
21
8
0
449
413
194727
934
2022
40958
614311

4087407
1276758
58700
15572
17359
43661
2239
9938
2462
951
1771

32043
1788
16120
16895
721
548
3559
0
1425
990
225471
1024
16725
488330
6322457

EN 

28 

EN 

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

Classes of animals 

Human 
Cardiovascular 
diseases 

Human 
nervous and 
mental disorder 

Human cancer 
(excl. evaluation of 
carcino. hazards) 

Other human 
diseases 

Specific animal 
diseases 

Total  

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

Classes of animals% 

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

249486 
125904 
2856 
2613 
5373 
1339 
5651 
118 
29 
4769 
6203 
404341 

858612 
489630 
5004 
9723 
1386 
560 
1093 
402 
55 
4963 
58657 
1430085 

803038 
43336 
262 
1030 
1781 
144 
211 
6 
5 
47 
5344 
855204 

1883499 
600979 
47326 
11844 
28138 
7291 
21146 
3903 
887 
21542 
391961 
3018516 

292772
16909
3252
7721
6983
6256
40516
399
449
195140
43914
614311

4087407
1276758
58700
32931
43661
15590
68617
4828
1425
226461
506079
6322457

Human 
Cardiovascular 
diseases 

Human 
nervous and 
mental disorder 

Human cancer 
(excl. evaluation of 
carcino. hazards) 

Other human 
diseases 

Specific animal 
diseases 

Total  

6,10 
9,86 
4,87 
7,93 
12,31 
8,59 
8,24 
2,44 
2,04 
2,11 
1,23 

21,01 
38,35 
8,52 
29,53 
3,17 
3,59 
1,59 
8,33 
3,86 
2,19 
11,59 

19,65 
3,39 
0,45 
3,13 
4,08 
0,92 
0,31 
0,12 
0,35 
0,02 
1,06 

46,08 
47,07 
80,62 
35,97 
64,45 
46,77 
30,82 
80,84 
62,25 
9,51 
77,45 

7,16
1,32
5,54
23,45
15,99
40,13
59,05
8,26
31,51
86,17
8,68

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

EN 

29 

EN 

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

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

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

100%

80%

60%

40%

20%

0%

e
c
M

i

s
t
a
R

Specific to animal diseases %

Other human diseases %

Human cancer (excluding evaluations of
carcino hazards ) %

Human nervous and mental disorders %

Human cardiovascular diseases %

l

s
a
m
n
a

i

l

d
e
d
o
o
b
-
d
o
C

l

s
t
i
b
b
a
R

i

s
r
o
v
n
r
a
C

s
t
n
e
d
o
r

r
e
h
t
O

l

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

+

o
i
t
r

A

s
d
r
i

B

l

s
a
m
m
a
M

r
e
h
t
O

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

i

i

i

s
g
P
-
a
e
n
u
G

i

P

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 that 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 types of studies on both human and animal diseases 
show a great similarity to the data of 2005. However, there is a substantial decrease in the use 
of  ‘other  mammals’  for  studies  of  human  diseases  in  particular  'other  human  diseases', 
whereas  the  opposite  is  observed  for  cold-blooded  animals  which  have  been  more  widely 
used in studies on human diseases rather than animal diseases. 

EN 

30 

   EN 

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

products for human medicine and dentistry and for veterinary medicine 

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

medicine and dentistry and for veterinary medicine 

The  consolidated  table  for  the  27  Member  States  reporting  the  origin  of  the  regulatory 
requirements in relation to animals used for the production and quality control of products for 
human medicine and dentistry and for veterinary medicine (EU Table 5) is presented in Table 
5.1 at the end of this chapter. 

III.6.2.  Treatment and interpretation of the data  

The  number  of  animals  used  in  tests  for  the  production  and  quality  control  of  products  for 
human  medicine  and  dentistry  and  for  veterinary  medicine  represents  14,9%  of  the  total 
number  of  animals  used  for  experimental  purposes.  Figure  5  gives  the  percentages  of  the 
animals used to satisfy the different regional 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

0,00

10,00

20,00

30,00

40,00

50,00

5.2     National legislation
specific to a single EC Member
State

2,6

5.3     EC legislation including
European Pharmacopoeia
(requirements)

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

0,049

5.5    Other legislation

2,6

5.6      Any combination of 5.2/
5.3/ 5.4/ 5.5

 5.7       No regulatory
requirements

6,4

41,1

47,0

The  largest  proportion  of  animals  in  this  area  (47%)  was  used  to  satisfy  requirements  from 
several pieces of legislation (from national, the EU, the Council of Europe member country 
legislation, and from legislation outside of the EU (Fig 5)). The testing carried out to satisfy 
EU legislation including the European Pharmacopoeia covered 41,1% of the animals used in 
this area. 

In comparison to the report of 2005 there is a net decrease in the number of animals used to 
satisfy simultaneously several pieces of legislation. On the other hand there is a net increase 
of tests carried out for the European legislation (including the European Pharmacopoeia). 

EN 

31 

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Consequently,  there  is  a  net  decrease  in  the  number  of  animals  used  to  satisfy  national 
legislation,  which  is  an  encouraging  trend  showing  an  attempt  to  move  towards  EU 
harmonisation of regulatory requirements. 

EN 

32 

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Table 5.1: Number of animals used in the production and quality control of products and devices for human medicine and 
dentistry and for veterinary medicine 
Regulatory requirements versus species 
Data of 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) 
1.b.  Rats (Rattus norvegicus) 
1.c.  Guinea-Pigs (Cavia porcellus) 
1.d.  Hamsters (Mesocricetus ) 
1.e.  Other Rodents (other Rodentia) 
1.f.  Rabbits (Oryctolagus cuniculus) 
1.g.  Cats (Felis catus) 
1.h.  Dogs (Canis familiaris) 
1.i.  Ferrets (Mustela putorius furo) 
1.j.  Other Carnivores (other Carnivore) 
1.k.  Horses, donkeys and cross breds (Equidae) 
1.l.  Pigs (Sus) 
1.m.  Goats (Capra) 
1.n.  Sheep (Ovis) 
1.o.  Cattle (Bos) 
1.p.  Prosimians (Prosimia) 
1.q.  New World Monkeys (Ceboidea) 
1.r.  Old World Monkeys (Cercopithecoidea) 
1.s.  Apes (Hominoidea) 
1.t.  Other Mammals (other Mammalia) 
1.u.  Quail (Coturnix coturnix) 
1.v.  Other birds (other Aves) 
1.w.  Reptiles (Reptilia) 
1.x.  Amphibians (Amphibia) 
1.y.  Fish (Pisces) 
1.z.  TOTAL 
(*) France reporting for 2007 
Examples: 

33233 
5107 
2519 
0 
0 
851 
43 
208 
0 
27 
307 
518 
68 
805 
139 
0 
0 
0 
0 
13 
0 
1887 
0 
0 
2260 
47985 

359722 
86403 
43916 
8916 
0 
107271 
614 
985 
2 
311 
225 
5436 
27 
1523 
2500 
0 
0 
0 
0 
50 
0 
117540 
0 
0 
1430 
736871 

371 
405 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
54 
0 
0 
0 
0 
0 
0 
0 
60 
0 
0 
0 
890 

21567 
16406 
6494 
358 
0 
1077 
8 
0 
0 
0 
0 
91 
3 
5 
6 
0 
0 
0 
0 
0 
0 
1676 
0 
0 
0 
47691 

569279 
105741 
62550 
3613 
30 
53039 
58 
982 
522 
0 
164 
2385 
10 
703 
414 
0 
33 
231 
0 
0 
0 
41194 
0 
0 
406 
841354 

43303 
5319 
5615 
2 
0 
20539 
10 
55 
48 
0 
2087 
994 
11 
5079 
469 
0 
0 
0 
0 
28 
0 
7556 
0 
0 
24137 
115252 

1027475 
219381 
121094 
12889 
30 
182777 
733 
2230 
572 
338 
2783 
9424 
119 
8169 
3528 
0 
33 
231 
0 
91 
0 
169913 
0 
0 
28233 
1790043 

5.2 - France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 - Spain is testing due to a Norwegian requirement 
5.5 – Poland is testing due to a US specific requirement 
5.6 - Germany is testing due to a Swiss requirement (also an EC requirement) 

Note: 

Example: 

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

Footnotes: 

1) 

EC  Member  States:  Austria,  Belgium,  Bulgaria,  Cyprus,  Czech  Rep.,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania,  Luxembourg,  Malta, 
Netherlands, Poland, Portugal, Romania, Slovakia, 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 

33 

EN 

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

used in toxicological and other safety evaluations 

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

and other safety evaluations  

The  consolidated  table  for  the  27  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 

The  use  of  animals  for  the  regulatory  requirements  of  different  regions  in  the  area  of 
toxicological or other safety evaluation presented in Figure 6 follows a similar pattern to that 
of  the  use  of  animals  used  for  regulatory  purposes  in  human  medicine,  dentistry  and  in 
veterinary medicine in different regions, presented in the Figure 5 in the previous chapter. 

As pointed out earlier, the number of animals used 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  

0,00

10,00

20,00

30,00

40,00

50,00

60,00

8,55

23,96

6.2     National legislation
specific to a single EC Member
State

6.3     EC legislation including
European Pharmacopoeia
(requirements)

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

0,10

6.5    Other legislation

2,58

6.6      Any combination of 6.2/
6.3/ 6.4/ 6.5

 6.7       No regulatory
requirements

15,15

49,66

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  for  toxicological  and  other  safety  evaluations 
since the last report is relatively low and represents about 15,800 animals. 

EN 

34 

   EN 

 
 
In comparison to the last report there is a net slight decrease in the proportion of animals used 
to simultaneously satisfy several pieces of regional 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 meant by the term 'no regulatory requirements', some 
Member States gave as an example projects using in-house methods to verify the safety and 
efficacy  of  veterinary  biologicals  and  medicinal  products  using  animals,  and  carried  out 
according  to  a  company’s  standards.  The  results  may  be  accepted  by  that  Member  State 
national authority, although not required by legislation. 

The testing carried out in 2008 to satisfy national 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 

35 

   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) 
1.b.  Rats (Rattus norvegicus) 
1.c.  Guinea-Pigs (Cavia porcellus) 
1.d.  Hamsters (Mesocricetus ) 
1.e.  Other Rodents (other Rodentia) 
1.f.  Rabbits (Oryctolagus cuniculus) 
1.g.  Cats (Felis catus) 
1.h.  Dogs (Canis familiaris) 
1.i.  Ferrets (Mustela putorius furo) 
1.j.  Other Carnivores (other Carnivore) 
1.k.  Horses, donkeys and cross breds 
(Equidae) 
1.l.  Pigs (Sus) 
1.m.  Goats (Capra) 
1.n.  Sheep (Ovis) 
1.o.  Cattle (Bos) 
1.p.  Prosimians (Prosimia) 
1.q.  New World Monkeys (Ceboidea) 
1.r.  Old World Monkeys (Cercopithecoidea) 
1.s.  Apes (Hominoidea) 
1.t.  Other Mammals (other Mammalia) 
1.u.  Quail (Coturnix coturnix) 
1.v.  Other birds (other Aves) 
1.w.  Reptiles (Reptilia) 
1.x.  Amphibians (Amphibia) 
1.y.  Fish (Pisces) 
1.z.  TOTAL 
(*)France is reporting for 2007 

35721 
17191 
660 
101 
204 
1179 
97 
626 
211 
296 
0 

172 
29 
2 
10 
0 
0 
0 
0 
0 
24 
10 
0 
0 
32582 
89115 

129353 
51343 
14723 
238 
0 
12694 
126 
1421 
32 
0 
0 

1177 
0 
75 
226 
543 
0 
265 
0 
0 
680 
7406 
0 
0 
29413 
249715 

752 
89 
84 
0 
0 
2 
4 
58 
0 
0 
0 

8 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
997 

5034 
11496 
390 
0 
0 
1744 
0 
769 
26 
0 
0 

181 
0 
0 
44 
0 
0 
732 
0 
0 
0 
5000 
0 
0 
1517 
26933 

198942 
194371 
15166 
1106 
191 
23426 
85 
8023 
0 
0 
1 

6102 
14 
322 
173 
0 
246 
4599 
0 
0 
1466 
36017 
0 
179 
27071 
517500 

28397 
20093 
960 
135 
0 
942 
10 
180 
0 
0 
21 

425 
0 
10 
0 
0 
24 
98 
0 
0 
0 
2798 
0 
112 
103688 
157893 

398199 
294583 
31983 
1580 
395 
39987 
322 
11077 
269 
296 
22 

8065 
43 
409 
453 
543 
270 
5694 
0 
0 
2170 
51231 
0 
291 
194271 
1042153 

Examples: 

6.2 - France is testing due to a UK (or FR) specific requirement 
6.3 - UK is testing according to EC legislation 
6.4 - Spain is testing due to a Norwegian requirement 
6.5 – Poland is testing due to a US specific requirement 
6.6 - Germany is testing due to a Swiss requirement (also an EC requirement) 

Note: 

Example: 

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

Footnotes: 

1) 

EC  Member  States:  Austria,  Belgium,  Bulgaria,  Cyprus,  Czech  Rep.,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania,  Luxembourg,  Malta, 
Netherlands, Poland, Portugal, Romania, Slovakia, 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 

36 

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

safety evaluations 

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

The consolidated table for the 27 Member States reporting on animals used in toxicity tests for 
the purpose of toxicological and other safety evaluations of products (EU Table 7) is presented 
in Table 7.1 at the end of this chapter. 

III.8.2.  Treatment and interpretation of the data 

For the convenience of the presentation of results some of the toxicity tests of Table 7.1 have 
been grouped according to systemic and local toxicity and CMR (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

0,00

10,00

20,00

30,00

40,00

50,00

44,99

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

Irritation /sensitization tests

4,61

 Sub- chronic and chronic toxicity

9,88

Mutagenicity and carcinogenicity

4,58

Reproductive and developmental
toxicity

9,13

Toxicity to aquatic vertebrates not
included in other columns

2,41

other

24,40

As pointed out in the previous chapter, the number of animals used in toxicological and other 
safety  evaluations  represents  8,7%  of  the  total  number  of  animals  used  for  experimental 
purposes. 

In  Figure  7  the  largest  percentage  (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  carcinogenicity,  mutagenicity  and  toxicity  to 
reproduction. Another important category 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,  healthcare  and  veterinary  products.  This  includes 
neurotoxicity, toxicokinetics, testing of biological evaluation of medical devices: Intracutaneous 
testing  of  reactivity  in  rabbits,  studies  into  the  penetration  of  nanoparticles  through  tissue  and 

EN 

37 

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their biocompatibility, studies into the evaluation of sensitization potential of dyestuffs used in 
the textile industry and pharmacological studies included in safety tests. 

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

There is a continuous increase over the last three reports of the proportion of animals used for 
acute and sub-acute tests, ranging from 36% - 42% to almost 45% respectively. 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 generic substances should be tested.  

On the other hand one can observe a steady decrease over the last three reports of the animals 
used  for  reproductive  toxicity  testing  from:  12%  to  10%  and  to  9%  respectively.  This 
demonstrates a saving since the 2005 report of 8,650 animals. 

A general decrease in the number of animals used for regulatory toxicological evaluation could 
be  attributed  to  the  use  of  alternative  methods  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 

38 

   EN 

 
Table 7.1: Number of animals used in toxicological and other safety evaluations 
Type of tests versus species 

7.1. Species 

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

Data of 2008* 

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 

7.12. 
Other 

7.13. 
Total 

7.11. 
Toxicity 
to 
aquatic 
vertebra
-tes not 
included 
in other 
columns 

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

(*) France reporting for 2007 

EN 

7.2.1. 
LD50, 
LC50 

7.2.2. 
Other 
lethal 
methods 

7.2.3. Non 
lethal 
clinical 
signs 
methods 

87440 
7060 
1000 
16 
27 
110 
0 
15 
0 
0 

0 

0 
0 
0 
0 
0 
0 
18 

87455 
12651 
303 
0 
0 
38 
0 
339 
0 
0 

0 

11 
0 
0 
0 
0 
0 
0 

0 
0 
819 
456 
0 
0 
50983 
147944 

0 
0 
241 
135 
0 
0 
70000 
171173 

46654 
74924 
3363 
343 
0 
5875 
24 
4637 
211 
0 

0 

535 
0 
36 
60 
261 
65 
1735 

0 
0 
0 
5937 
0 
0 
5110 
149770 

926 
768 
140 
22 
0 
4200 
0 
0 
0 
0 

0 

115 
0 
0 
0 
0 
0 
0 

0 
0 
0 
1020 
0 
0 
119 
7310 

16742 
1465 
20198 
0 
0 
32 
0 
0 
0 
0 

0 

0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
38437 

39 

30 
78 
6 
0 
0 
2105 
0 
0 
0 
0 

0 

0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
65 
0 
0 
0 
2284 

27173 
54915 
618 
310 
204 
1240 
62 
4582 
0 
0 

0 

937 
0 
34 
12 
143 
71 
2861 

0 
0 
0 
0 
0 
108 
9735 
103005 

10375 
10219 
0 
0 
0 
0 
0 
0 
0 
0 

0 

0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
213 
20807 

3744 
20263 
120 
0 
0 
6047 
0 
0 
0 
0 

0 

0 
0 
0 
0 
0 
64 
176 

0 
0 
0 
0 
0 
4 
868 
31286 

12858 
14043 
0 
21 
0 
0 
0 
0 
0 
0 

0 

0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
26922 

2759 
51314 
101 
0 
0 
5349 
0 
20 
0 
0 

0 

112 
0 
0 
22 
0 
0 
58 

0 
0 
176 
108 
0 
0 
3796 
63815 

200 
26 
7 
0 
0 
7 
0 
0 
0 
0 

0 

0 
0 
0 
0 
0 
0 
0 

101843 
46957 
6027 
868 
164 
14984 
236 
1484 
58 
296 

22 

6355 
43 
339 
359 
139 
70 
846 

398199 
294683 
31883 
1580 
395 
39987 
322 
11077 
269 
296 

22 

8065 
43 
409 
453 
543 
270 
5694 

0 
0 
0 
0 
0 
0 
24857 
25097 

0 
0 
934 
43510 
0 
179 
28590 
254303 

0 
0 
2170 
51231 
0 
291 
194271 
1042153 

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 

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

221549 
94635 
4666 
359 
27 
6023 
24 
4991 
211 
0 
0 

546 
0 
36 
60 
261 
65 
1753 
0 
0 
1060 
6528 
0 
0 
126093 

468887 

17698 
2311 
20344 
22 
0 
6337 
0 
0 
0 
0 
0 

115 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1085 
0 
0 
119 

27173 
54915 
618 
310 
204 
1240 
62 
4582 
0 
0 
0 

937 
0 
34 
12 
143 
71 
2861 
0 
0 
0 
0 
0 
108 
9735 

23233 
24262 
0 
21 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
213 

6503 
71577 
221 
0 
0 
11396 
0 
20 
0 
0 
0 

112 
0 
0 
22 
0 
64 
234 
0 
0 
176 
108 
0 
4 
4664 

48031 

103005 

47729 

95101 

EN 

40 

Toxicity to 
aquatic 
vertebrates not 
included in 
other columns 
200 
26 
7 
0 
0 
7 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
24857 

25097 

other 

Total  

101843
46957
6027
868
164
14984
236
1484
58
296
22

6355
43
339
359
139
70
846
0
0
934
43510
0
179
28590

398199 
294683 
31883 
1580 
395 
39987 
322 
11077 
269 
296 
22 

8065 
43 
409 
453 
543 
270 
5694 
0 
0 
2170 
51231 
0 
291 
194271 

254303

1042153 

EN 

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

other safety evaluations of products 

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

evaluations of products 

The  consolidated  table  for  the  type  of  toxicity  tests  carried  out  for  toxicological  or  other 
safety evaluations of products for the 27 Member States reporting (EU table 8) is presented in 
table 8.1 of this report. The data in table 8 have been subjected  to  a further quality criteria 
check developed by the Commission. The data provided by all Member States for this report 
were coherent.  

III.9.2.  Treatment and interpretation of the data 

As  pointed  out  earlier,  animals  used  in  toxicological  and  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 toxicity testing have been 
grouped  and  the  results  can  be  found  in  consolidated  table  8.2  at  the  end  of  this  chapter. 
Figure 8 gives the proportion of animals used for toxicity and other safety evaluation by types 
of products. 

The treatment and interpretation of the data on animals used for toxicity tests with regard to 
the  type  of  products  was  done  for  the  first  time  in  the  Fifth  Statistical  Report.  However, 
because  the  graph  in  that  report  represented  more  the  relative  importance  of  tests  within  a 
type  of  product  rather  than  the  proportion  of  animals  used  per  type  of  test  for  the  different 
products, the graph was modified accordingly for this report.  

Figure 8
Proportion of animals used for toxicity tests for toxicological 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

Carcinogenicity, Mutagenicity and Reprotox

Toxicity to aquatic vertebrates not included
in other columns

Other

0% 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
evaluations

EN 

41 

   EN 

 
 
Figure 8 shows that the majority of animals tested in acute/sub-acute toxicity are intended for 
the purpose of human medicine, dentistry and veterinary medicine. This is followed by tests 
carried out for other toxicological or safety evaluation 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’ toxicological evaluations, above 20%, followed by animals used in 
tests for products for agriculture and industry each above 7%.  

EN 

42 

   EN 

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

8.1. Products 

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

8.3. Skin 
irritation 

Data of 2008* 

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 

8.12. 
Other 

8.13. 
Total 

8.11. 
Toxicity to 
aquatic 
vertebra-
tes not 
included 
in other 
columns 

8.2.1. 
LD50, 
LC50 

8.2.2. 
Other 
lethal 
methods 

43643 

85795 

8.2.3. Non 
lethal 
clinical 
signs 
methods 
116481 

3732 

17719 

506 

62442 

15063 

12314 

14286 

37079 

3917  116640 

529617 

9066 

4192 

4987 

724 

4252 

581 

10089 

3590 

3120 

2224 

11578 

11884 

7860 

74147 

5263 

4832 

12483 

2368 

11129 

1001 

8324 

306 

11475 

6490 

8863 

2870 

7022 

82426 

617 

1636 

50 

143 

0 

822 

207 

98 

87 

699 

64 

112 

213 

0 

9142 

177 

3 

0 

37714 

6243 

2206 

119 

0 

0 

0 

27 

54 

6 

0 

0 

159 

0 

0 

0 

0 

0 

114 

1016 

0 

0 

1421 

649 

3157 

320 

167 

0 

0 

0 

520 

4282 

0 

1967 

128 

6240 

100 

0 

0 

0 

0 

80 

44665 

54164 

6294 

213 

85 

1502 

4111 

4713 

3410 

66610 

10080 

60404 

7909 

173 

1797 

94 

8004 

2625 

319 

2937 

3176 

1234  123948 

222700 

8.a. Products/ substances or devices 
for human medicine and dentistry 
and for veterinary medicine  
8.b. Products/ substances used or 
intended to be used mainly in 
agriculture 
8.c. Products/ substances used or 
intended to be used mainly in 
industry 
8.d. Products/ substances used or 
intended to be used mainly in the 
household 
8.e. Products/ substances used or 
intended to be used mainly as 
cosmetics or toiletries 
8.f. Products/ substances used or 
intended to be used mainly as 
additives in food for human 
consumption 
8.g. Products/ substances used or 
intended to be used mainly as 
additives in food for animal 
consumption 
8.h. Potential or actual contaminants 
in the general environment which do 
not appear in other columns 
8.i. Other toxicological or safety 
evaluations 

8.j. TOTAL 

107269 

172563 

144604 

7349 

35596 

2269 

96833 

22446 

30470 

27873 

65990 

24698  304193 

1042153 

(*) France reporting for 2007 

EN 

43 

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 

carcinogenicity, 
Mutagenicity 
and Reprotox. 

Sub- 
chronic 
and 
chronic 
toxicity 

Toxicity to 
aquatic 
vertebrates 
not 
included in 
other 
columns 

Other 

Total 

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

8.c. Products/ substances used or intended 
to be used mainly in industry 

8.d. Products/ substances used or intended 
to be used mainly in the household 

8.e. Products/ substances used or intended 
to be used mainly as cosmetics or toiletries 

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

8.j. TOTAL 

245919 

21957 

62442 

78742 

3917 

116640

529617

18245 

22578 

2303 

1127 

389 

9319 

5557 

10089 

20512 

11884 

7860

74147

14498 

8324 

27134 

2870 

7022

82426

170 

840 

9 

0 

159 

0 

1130 

0 

1421 

4293 

0 

0 

0 

520

4282

0

1967

128

6240

100 

0 

80 

44665

54164

46163 

119 

6294 

5911 

4713 

3410

66610

78393 

424436 

2064 

8004 

9057 

1234 

123948

222700

45214 

96833 

146779 

24698 

304193

1042153

EN 

44 

EN