Report from the Commission to the Council and the European Parliament - Fifth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union {SEC(2007)1455}
Date: 2007-11-05
Institutions: European Commission
Subjects: EU statistics, animal experimentation, animal welfare, report, scientific research

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.11.2007 
COM(2007) 675 final 

REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT  

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

{SEC(2007)1455} 

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TABLE OF CONTENTS 

1. 

I. 

I.1. 

I.2. 

II. 

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

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

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

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

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

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

III.1.1.  Comparison with the data of the previous reports ....................................................... 4 

III.1.2.  Comparison with the data of the previous reports for the EU 15................................. 5 

III.2. 

Further results of EU Table 1: Origin of animals used................................................ 6 

III.3.  Results of EU Table 2: Purposes of the experiments................................................... 6 

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

product/endpoints......................................................................................................... 7 

III.5.  Results of EU Table 4: Animals used for studies of diseases ...................................... 8 

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 test 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.................................................................................... 14 

1. 

INTRODUCTION 

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

The first two statistical reports published in 19942 and 19993 covering data on experimental 
animals  collected  in  1991  and  1996  respectively  provided  a  limited  amount  of  statistical 
analysis  due  to  the  absence  of  a  consistent  system  of  reporting  the  data  on  the  use  of 
experimental animals in the Member States. In 1997 an agreement was reached between the 
competent authorities of the Member States and the Commission to submit data for the future 
reports under a format of eight harmonized tables. The third and the fourth statistical reports 

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

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published in 20034 and 20055 covering data collected in 1999 and 2002 were based on these 
agreed harmonized tables. This allowed a much wider interpretation of the results on the use 
of experimental animals in the EU. In spite of the progress made in the content of these two 
last statistical reports, it ought to be stressed that there were some inconsistencies in the data 
submitted by the Member States. 

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

This  Report  summarizes  the  data  and  conclusions  found  in  the  Commission  Staff  Working 
Document - "Fifth Report on the Statistics on the Number of Animals used for Experimental 
and other Scientific Purposes in the Member States of the European Union". 

I. 

I.1. 

DATA SUBMITTED AND GENERAL ASSESSMENT 

Data submitted by the Member States  

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

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

I.2. 

General assessment 

The EU 10 are reporting data for the first time, therefore it is not possible to draw 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  will  be  attempted 
and  significant  changes  in  use  will  be  highlighted  in  the  report.  Malta  informed  the 
Commission that no animal experiments were carried out in their country in 2005. 

The total number of animals used for experimental and other scientific purposes in 2005 in the 
25  Member  States  (EU  25)  amounts  to  12,1  million  (with  data  from  France  of  2004).  The 
number of animals used in the EU 10 represents 8,6% of the total number of animals used in 
the EU 25. 

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

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

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

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

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II. 

RESULTS 

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

The total number of animals used in 2005 in the EU 25 amounts to 12,1 million animals. Mice 
(53%)  and  rats  (19%)  were  by  far  the  most  used  species  (fig.1.1).  Rodents  together  with 
rabbits represent 77,5% of the total number of animals used. Cold-blooded animals with 15% 
represented the second most used group of animals followed by birds with 5,4%. The Artio 
and  Perissodactyla  group  including  horses,  donkeys  and  crossbreeds  (Perrisodactyla),  pigs, 
goats, sheep and cattle (Artiodactyla) represented only 1,1%. Carnivores represented 0,3% of 
the total number of animals used in 2005 and non-human primates represent 0,1%. 

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

 Carnivores 0,33%

Prosimians+Monkeys+
Apes 0,09%

Artio+perissodactyla 
1,1%

 Birds 5,4%

Cold-blooded  animals 
15%

 Rabbits 2,6%

Other rodents 0,8%

Guinea-Pigs 2,1%

Rats 19%

Other mammals 0,08%

Mice 53%

III.1.1.  Comparison with the data of the previous reports  

The number of animals used in the EU 10, which reported for the first time, represents 8,6% 
of  the  total  number  of  animals  in  the  EU  25.  This  proportion  will  be  used  as  the  basis  to 
highlight any changes in trends which significantly deviate from it. 

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

Class of species 

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

1996(*) 
81,3 
12,9 

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

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

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

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 

From the above table, overall, the percentages of rodents and rabbits show some fluctuation 
around  80%.  For  cold-blooded  animals  the  proportion  used  in  1996,  in  2002  and  2005  is 
between 10 to 15% but a much lower use of 6,6% was observed in 1999. Birds representing 
the third largest percentage of animal used, varies between 4 to 5%. The group of artio and 
perissodactyla fluctuates around 1%. 

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The  inclusion  of  the  data  of  the  EU  10  should  in  principle  increase  the  actual  numbers  of 
animals  of  each  species  with  the  magnitude  of  around  8,6%.  However,  the  use  of  some 
species  has  decreased  compared  to  the  2002  report.  The  total  number  of  hamsters,  goats, 
prosimians, quails and reptiles have all decreased from 40% to 22%.  

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

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

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

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

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

III.1.2.  Comparison with the data of the previous reports for the EU 15 

Since the total number of animals include the data from the 10 new Member States it is not 
possible to draw comparison per se with the results of the previous reports. However, to allow 
for  some  comparisons  of  trends  of  the  animal  use,  a  comparison  of  the  number  of  animals 
used by the EU 15 in 2002 and by the EU 15 in 2005 was made. 

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

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

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

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

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

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

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

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

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

III.2.  Further results of EU Table 1: Origin of animals used 

Although the origin only has to be reported for selected animal species, it is evident that the 
majority of the species originated mainly from EU countries (fig 1.2), with the exception of 
old world monkeys. 

Figure 1.2:  Origin of species 

100%

80%

60%

40%

20%

0%

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ETS 123 countries

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The  general  pattern  on  the  origin  of  the  species  is  quite  similar  to  that  observed  in  the 
previous  reports.  It  should  be  noted  however,  that  for  the  first  time  in  2005  the  prosimians 
were  all  of  EU  origin.  A  similar  trend  can  also  be  observed  with  the  new  world  monkeys 
where  an  increasing  amount  was  either  of  EU  or  ETS  123  origin  at  the  expense  of  other 
countries. Also, old world monkeys coming from EU origins increased. On the other hand the 
number of cats not of European origin has increased in comparison to the report of 2002. 

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  2.1).  Production  and 
quality control of products and devices in human medicine, veterinary medicine and dentistry 
required the use of 15,3% of the total number of animals reported in 2005. Toxicological and 
other safety evaluation represented 8% of the total number of animals used for experimental 
purposes. 

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Figure 2.1 
Purposes of experiments

Education and training 
1,6%

Other 8%

Diagnosis of disease 2%

Toxicological and other 
safety evaluation 8%

Production and quality 
control veterinary 
medicine 3.5%

Fundamental biology 
studies 33%

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

Research and develop 
human +veterin+dentist 
31%

Comparison with the data of the previous report  

The comparison is aiming to detect changes in trends rather than drawing formal conclusions. 
The  most  significant  change  that  can  be  identified  is  the  number  of  animals  used  for 
toxicological and other safety evaluation, which has dropped from about 9,9% (data of 2002) 
to  8%.  The  decrease  is  also  important  in  total  numbers,  i.e.  from  1,066,047  to  1,026,286 
animals while at the same time covering the 10 new Member States. 

The percentage of animals used for education and training is also showing a decreasing trend, 
while  'other'  purposes  seem  to  indicate  an  increase.  In  terms  of  numbers  of  animals  the 
decrease  ranges  from  341,967  to  198,994  and  the  increase  from  597,960  to  984,238 
respectively. The decrease of animals used for education and training can be attributed to both 
an uptake of alternative techniques and the re-use of animals. 

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

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

product/endpoints 

Only  8%  of  the  total  number  of  animals  used  for  experimental  purposes  is  used  for 
toxicological  and  other  safety  evaluation.  Products  or  devices  used  for  human  medicine, 
veterinary  medicine  and  dentistry  represents  50,9%  (fig  3.1)  of  the  animals  used  for 
toxicological  or  other  safety  evaluations.  The  percentage  of  animals  used  for  toxicological 
evaluation  of  groups  of  products/substances,  i.e.,  animal  feed,  additives  for  human  food 
consumption,  cosmetics  and  household,  is  very  small  (4,3%)  when  compared  to  the  other 
products groups. 

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

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Figure 3.1
Animals used in toxicological and other safety experiments

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

3.10    Other  toxicological or 
safety evaluations
17,6%

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

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

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

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

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

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

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

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

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

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

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

In  2005,  the  number  of  animals  used  for  the  study  of  both  animal  and  human  diseases 
represented  more  than  half  (57,5%)  the  total  number  of  animals  used  for  experimental 
purposes  in  the  EU.  The  percentage  of  the  number  of  animals  used  for  studies  of  human 
diseases  represents  81%  of  the  total  number  of  animals  used  for  all  studies  of  diseases  (fig 
4.1). 

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Figure 4.1
Proportion of animals used for the study of diseases

Human 
Cardiovascular 
diseases
6%

Specific animal 
diseases
19%

Other human 
diseases
40,5%

Human nervous and 
mental disorder
21,6%

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

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

Studies  on  specific  animal  diseases  are  important  in  the  light  of  epidemics  of  farm  animals 
such  as  in  the  case  of  cows,  foot  and  mouth  disease,  swine  fever  and  more  recently  avian 
flew. Animals used cover also study on genetic diseases. 

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

The relative percentage of animals per classes of species used in studies by type of diseases is 
presented in fig 4.2. The top of each bar shows the percentage of animals used for studies on 
specific animal diseases. Two groups of animals i.e. birds and cold-blooded animals account 
for more than 80% of such studies. It was reported that a significant number of vaccines are 
tested on these groups of animals. 

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

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40%

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Specific animals diseases  %

Other human diseases %

Human cancer (excl. evaluation of
carcino hazards) %

Human nervous and mental disorder
%

Human Cardiovascular diseases%

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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  15,3%  of  the  total 
number of animals used for experimental purposes. The largest proportion of animals in this 
area (57%) was used to simultaneously satisfy requirements from several legislations such as 
national, Community, Council of Europe or others (fig 5.1). The testing carried out to satisfy 
the EU legislation including the European Pharmacopoeia covered 33,3% of the animals used 
in this area. 

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

0,00

10,00

20,00

30,00

40,00

50,00

60,00

5.2     National legislation
specific to a single EC Member
State

2,56

5.3     EC legislation including
European Pharmacopoeia
(requirements)

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

0,01

5.5    Other legislation

2,10

5.6      Any combination of 5.2/
5.3/ 5.4/ 5.5

 5.7       No regulatory
requirements

5,16

33,31

2005

56,85

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

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

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

Animals  used  to  simultaneously  satisfy  regulatory  requirements  from  several  legislations 
covered more than half of the animals used in this area (54,2%) (fig 6.1). The testing required 
under  the  EU  legislation  including  the  European  Pharmacopoeia  accounts  for  the  second 
highest percentage in this area, namely 23%. 

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

0,00

10,00

20,00

30,00

40,00

50,00

60,00

9,39

23,65

6.2     National legislation
specific to a single EC Member
State

6.3     EC legislation including
European Pharmacopoeia
(requirements)

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

0,12

6.5    Other legislation

3,93

6.6      Any combination of 6.2/
6.3/ 6.4/ 6.5

 6.7       No regulatory
requirements

8,71

54,20

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

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

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

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

safety evaluations 

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

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

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

0,00

10,00

20,00

30,00

40,00

50,00

42,01

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

Irritation /sensitization
tests

5,88

 Sub- chronic and chronic
toxicity

10,90

Mutagenicity and
carcinogenicity

7,55

Reproductive and
developmental toxicity

10,11

Toxicity to aquatic
vertebrates not included in
other columns

1,24

other

22,32

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

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

Another important decrease, from 4,5% to 1,2%, is seen in animals used in toxicity tests for 
aquatic vertebrates. 

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

safety evaluations of products 

Figure 8.1 represents the percentages of the number of animals used in toxicological testing or 
other safety evaluations in relation to the type of products or purposes. It shows a decrease in 
the proportion of animals used in acute and sub-acute toxicity tests in comparison with other 
tests when moving down in the graph for products used A) for human medicine, dentistry and 
veterinary  medicine,  B)  for  agriculture,  C)  for  industry,  D)  for  household  purposes,  E)  for 
cosmetics, F)  for additives  in  food  for human consumption  and G) for additives in food for 
animal consumption. 

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

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

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

 A) for human medicine, dentistry and for
veterinary medicine   

B) used  in agriculture

C) used in industry

D) used  in the household

E) used as cosmetics or  toiletries

F) additives in food for human consumption

G) additives in food for animal consumption

H) potential  or actual contaminents in the
general environment 

I)  other  toxicological or safety evaluations

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

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

Sub- chronic and chronic toxicity

Mutagenicity and carcinogenicity

Reproductive and developmental
toxicity

Toxicity to aquatic vertebrates not
included in other columns

Other

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

The proportion of animals used for G) additives in food for animal consumption is governed 
by about 90% by 'other' tests. It would be valuable to break down the term 'other' for future 
reporting. 

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