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 SEC(2010) 1107
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  
COM(2010) 511 final/2  

CORRIGENDUM: 
Annule et remplace le document COM(2010) 511 du 30.9.2010 final 
Concerne : toutes les versions 

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 
SEC(2010) 1107 

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TABLE OF CONTENTS 

I. 

II. 

INTRODUCTION........................................................................................................ 2 

DATA SUBMITTED AND GENERAL ASSESSMENT........................................... 3 

II.1. 

Data submitted by the Member States ......................................................................... 3 

II.2. 

General assessment ...................................................................................................... 3 

III. 

RESULTS .................................................................................................................... 4 

III.1.  Results of EU Table 1: Species and number of animals .............................................. 4 

III.1.1.  Results concerning species used .................................................................................. 4 

III.1.2.  Comparison with the data of the previous reports ....................................................... 5 

III.2.  Results of EU Table 1: Origin of animals used ........................................................... 6 

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

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

product/endpoint .......................................................................................................... 8 

III.5.  Results of EU Table 4: Animals used for studies of diseases ...................................... 9 

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 ................................ 10 

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

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

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

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

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

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

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 

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

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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 tables. This allowed a much wider interpretation of the 
results on the use of experimental animals in the EU. 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 Sixth Statistical 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, and summarizes the data and conclusions found in the Commission 
Staff Working Document – 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.  

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. The data quality control 
showed  acceptable  quality  for  the  data  submitted  for  2008.  This  applies  also  to  the  new 
Member States Bulgaria and Romania who reported for the first time.  

The  individual  data  from  the  Member  States  together  with  their  respective  comments  and 
interpretations can be found in the Staff Working Document. 

II.2.  General assessment 

As  the  two  newest  Member  States  Bulgaria  and  Romania  have  submitted  data  for  the  first 
time  (representing  below  1,0%  of  the  total  number  of  animals  used  in  the  EU  27),  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, some comparisons in trends have been attempted, and significant changes 
in use have been highlighted in the report.  

The  total  number  of  animals  used  for  experimental  and  other  purposes  in  2008  in  the  27 
Member States EU (27) is just above 12,0 million.  

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%.  

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COM (2003) 19 final 
COM (2005) 7 final 
COM (2007) 675 final 

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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.  

III. 

RESULTS  

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

III.1.1.  Results concerning species used 

Malta has hitherto reported no animal use for scientific purposes, but reported the use of 690 
animals in 2008.  

Mice (59%) and Rats (17%) were by far the most used species (Figure 1.1.).  

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. 
The second most used group of animals was, as in the previous years cold-blooded animals 
namely reptiles, amphibians and fish representing 9,6% followed by birds with 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. 

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III.1.2.  Comparison with the data of the previous reports  

The aim of this report is to indicate whether important changes have occurred related to use of 
different species, although rigorous comparisons cannot be made with previous reports. 

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  (perissodactyla)  and  pigs, 
goats, sheep and cattle (artiodactyla) fluctuates at around 1%. 

The inclusion of the data from 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. 
However, noticeable changes have occurred for the use of some individual species compared 
to data from the 2005 report.  

Significant  increases  occurred  in  2008  for  mice,  rabbits,  pigs  and  'other  birds'  where 
percentage changes ranged from 6,6% to 40%. The increase in the number of mice used since 
2005 is 691,842 animals which represents 10,7% of the total number of mice used in 2005. 
The  total  number  of  pigs,  goats,  prosimians,  and  reptiles  has  increased  by  between  40  and 
86,3%. On the other hand 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 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'.  

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%).  

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. As in 2002 and 2005, no great apes were used for 
experimental or other scientific purposes in 2008. 

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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, canary, parakeet, parrot and farmed avian species for example, chickens. 

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

According to the standardised EU tables the origin must only be reported for certain selected 
animal species. 

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

1 0 0 %

8 0 %

6 0 %

4 0 %

2 0 %

0 %

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The  chart  shows  clearly  that  the  majority  of  the  species  originated  from  EU  countries. 
However,  certain  species  such  as  cats,  dogs,  ferrets  and  old  world  monkeys  are  of  non-
European  origin.  The  origin  of  the  species  were  quite  similar  to  that  observed  in  previous 
reports.  However,  for  the  first  time  in  2005  the  prosimians  used  were  all  of  EU  origin  and 
have  remained  so.  A  similar  trend  can  also  be  observed  with  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. The number of cats of EU 

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origin  also  increased  whereas  dogs  and  ferrets  of  non-European  origin  have  remained 
unchanged since 2005. 

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

More  than  60%  of  animals  were  used  in  research  and  development  for  human  medicine, 
veterinary  medicine,  dentistry  and  in  fundamental  biology  studies  (Fig  2).  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 represented 8,7% of the total number of animals used for experimental purposes.  

Figure 2
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%

Bearing in mind that 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 was 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. For additional details see the Staff Working Document.  

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. 

There is a substantial increase in the use of mice and rabbits for the production  and  quality 
control of products and devices for human medicine and dentistry', but also an increase in use 
of  mice,  pigs  and  birds  for  'fundamental  biological  research'  and  in  'other  experiments'. 
Several  Member  States  confirmed  that  this  increase  in  the  use  of  mice  is  attributed  to  new 

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research possibilities offered by the transgenic species. These animal models are being used 
for both 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. 

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

product/endpoint 

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 the EU. 

Of this total, animals used for toxicological or other safety evaluations of products or devices 
used  for  human  medicine,  veterinary  medicine  and  dentistry  represented  50,8%  and  was 
therefore the purpose using the largest number of the animals. 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. The percentages of animals used for toxicological or 
other  safety  evaluation  of  industrial  and  agricultural  products  are  respectively  representing 
7,1% and 7,9% of the number of animal used for that purpose (see Fig. 3). Other toxicological 
and safety evaluation represented more than 21%. 

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%

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 

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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 radical change should be seen in light of the legal requirement to phase out animal 
testing for cosmetics in the EU.  

There is, however, 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).  There  is  also  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. 

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

The  number  of  animals  used  in  2008  for  studies  of  both  animal  and  human  diseases 
represented approximately 52% of the total number of animal used for experimental purposes.  

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. (Fig 4.1) 

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%

There  has  been  a  50%  decrease  in  animals  used  for  studies  on  animal  diseases  -  from 
1,329,000  to  614,000.  The  use  of  cold-blooded  species  has  decreased  from  around  954,000 
animals  in  2005  to  43,914  in  2008.  However,  the  use  of  mice  has  increased  substantially. 
Around 30% of the increase (about 681,000) can be attributed to disease studies. 

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There has also been an increase in the number of birds used for studies on animal diseases. 
Member States reported studies on bird flu, Gumboro disease and bronchitis including studies 
on quality and safety of vaccines. 

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

100%

80%

60%

40%

20%

0%

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Specific to animal diseases %

Other human diseases %

Human cancer (excluding evaluations of
carcino hazards ) %

Human nervous and mental disorders %

Human cardiovascular diseases %

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In Figure 4.2 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  birds  are  only  used  if  the 
infection concerns bird species. 

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 

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. 

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

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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

In comparison to the last report there is a net increase 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  to  satisfy  EU  legislation  including  the  European  Pharmacopoeia.  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. 

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

used in toxicological and other safety evaluations 

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. 

Of  this  total,  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  accounted  for  the 
second highest percentage in this area, namely 24%. 

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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

In comparison to the last report there is a slight decrease in the proportion of animals used to 
simultaneously satisfy several pieces of regional legislation from 54% to 50%.  

On  the  other  hand  there  is  a  substantial  increase  in  the  proportion  of  animals  used  for  no 
regulatory requirements from 5 to over 15,0%. 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. 

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

safety evaluations 

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 (Fig 7). 

13,7%  of  animals  were  used  for  testing  carcinogenicity,  mutagenicity  and  toxicity  to 
reproduction. Another important category of use of animals in 2008 was 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, 
testing  of  biological  evaluation  of  medical  devices: 
Intracutaneous  testing  of  reactivity  in  rabbits,  studies  into  the  penetration  of  nanoparticles 

toxicokinetics, 

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

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

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. Since the last 
report, this represents in animal numbers an increase of more than 37,000 animals. 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 there is a steady decrease over the last three reports of the animals used for 
reproductive toxicity testing from: 12% to 10% and to 9% respectively. In terms of animals it 
means a saving since the 2005 report of 8,650 animals. 

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

safety evaluations of products 

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 evaluations, and then for agriculture and industrial 
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. 

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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

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 for industry each above 7%. 

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