EN EN
EUROPEAN
COMMISSION
Brussels, 5.12.2013
SWD(2013) 497 final
PART 1/5
COMMISSION STAFF WORKING DOCUMENT
Accompanying document to the
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN
PARLIAMENT
Seventh 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(2013) 859 final}
EN 2 EN
COMMISSION STAFF WORKING DOCUMENT
Accompanying document to the
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN
PARLIAMENT
Seventh Report on the Statistics on the Number of Animals used for Experimental and
other Scientific Purposes in the Member States of the European Union
EN 3 EN
I. INTRODUCTION
The objective of this report is to present statistical data on the number of animals used for
scientific purposes in the Member States of the European Union during the year 2011(*) in
accordance with provisions of Article 26 of Directive 86/609/EEC of 24 November 1986 1
regarding the protection of animals used for experimental and other scientific purposes.
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, allowed only 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 1997 an agreement was reached between the competent authorities
of the Member States and the Commission to submit data for future reports under a format of
eight harmonized tables. The Fifth Statistical report published in 20074
contained for the first
time data collected in the 10 Member States which joined the EU in 2004. The Sixth
Statistical Report published in 20105
gave an overview of the number of animals used in the
year 2008 in 27 Member States.
This Seventh Statistical Report contains the results of the data collected by all 27 Member
States in 2011 with the exception of one (France) which provided data from 2010.
The Commission Staff Working Document accompanies the Report from the Commission to
the Council and the European Parliament – Seventh Report on the Number of Animals used
for Experimental and other Scientific Purposes in the Member States of the European Union.
The report summarises the data and conclusions presented in this document.
(*) Except for one Member State reporting for 2010
1
OJL 358, 18.12.1986, p.1.
2
COM (94) 195 final
3
COM (1999) 191 final
4
COM (2007) 675 final
5
COM (2010) 1107 final/2
EN 4 EN
II. DATA SUBMITTED AND GENERAL ASSESSMENT
II.1. Data submitted by the Member States
As in 2008 all 27 Member States submitted the data in the agreed format of the eight EU
Tables, referred to as table 1 to 8 hereunder.
A quality control check has been carried out on the set of data submitted for 2011 that is
essentially governed by five criteria based on certain relationships between the data in the
different tables.
– The first of these relationships concerns the total number of animals used by species of
column 1.2 of table 1 and of column 2.10 of table 2. Since both tables concern the total of
animals used by species the totals of the tables 1 and 2 should be identical.
– The second relationship concerns column 2.6 of table 2 'animals used for toxicological and
other safety evaluation' which is broken down into types of products/endpoints in table 3;
into Regulatory requirements in table 6; and into types of toxicological tests in table 7.
Therefore, the totals 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'.
– The third relationship is that the sum of column 2.4 and 2.5 of table 2 must be equal to the
total of table 5.
– The fourth relationship exists between the total row of table 3 and the total column of
table 8. Both the row and the column concern the total number of animals used for
toxicological and other safety test by type of products/procedure and should therefore be
equal.
– In the fifth relationship, the total row of table 7 should be equal to the total row of table 8.
The first and last two criteria have not been fully respected in the most recent collection of
data by some Member States and could unfortunately not be corrected in time for the start of
the analysis for this report. Despite these marginal errors, the data provided by the Member
States give a consistent basis for a sound statistical analysis of all eight EU Tables.
II.2. General assessment
Each Member State is requested, pursuant to Article 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 2011 with the exception of France which
provided data from 2010.
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 purposes6
allowed the use of animals in experiments for education and training, but where the purposes
of such experiments were not covered by the Directive, Member States according to the
Resolution applied national provisions which are no less severe than those of the Directive.
Therefore, when reporting a number of Member States have also included animals covered by
the Resolution in the report.
It should be noted that this is the last time that animal use data has been collected in
accordance with the requirements of Directive 86/609/EEC. This Directive has been replaced
by Directive 2010/63/EU on the protection of animals used for scientific purposes, and the
6
OJ C 331, 23.12.86, p. 2.
EN 5 EN
submission and publication of data have been completely revised with effect from 10 May
2013.
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 2011. 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.
Due to differences in the reporting year and an increase in the number of Member States over
the years, it is not possible to draw accurate quantitative conclusions on the evolution of the
use of animals for experimental purposes in the EU. However, some trend comparisons have
been made, and any 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 the respective comments.
In the EU, the total number of animals used for experimental and other scientific purposes
from the data collected in 2011 in accordance with the provision of the Directive for this
report is just under 11,5 million (with data from France from 2010). This is a reduction of
over half a million animals in the EU since the previous report covering the year 2008. The
Member States contributing with a biggest net reduction include Belgium, France, Italy,
Sweden and UK. In addition, credit should be given to some of the other Member States using
smaller numbers of animals, however, with a significant drop in percentage terms.
As in previous reports rodents and rabbits represent 80% of the total number of animals used
in the EU. Mice are by far the most commonly used species accounting for 61% of the total
use, followed by rats with 14%.
The second most used group of animals was, as in previous years, cold-blooded animals
which represent almost 12,5%. The third largest group of animals used was birds with 5,9%
of the total use.
As stated in the previous three statistical reports no ‘Great Apes’ were used in experiments in
the EU in 2011.
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 2011.
A consolidated table has been computed on the basis of the data submitted 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.
As France submitted data from 2010 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 numbering of tables and graphical presentation in Part A of the report are linked
EN 6 EN
to the numbers of the EU tables and not to the numbering of the chapters of the
report.
B Contains the data submitted by each Member State with Member State comments.
EN 7 EN
PART A: COMPILATION AND OVERVIEW OF THE DATA OF
2011
III.1. Results of EU Table 1: Species and number of animals
Two types of information can be drawn from the data submitted 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 Member States
Table 1.1 of this report presents the consolidated data on the number of animals used by
species.
The total number of animals used in 2011 in the 27 Member States amounts to
11 481 521 animals. It is important to note that the total number of animals used in 2011 has
decreased by over 500 000 (4.3%) animals in comparison to 2008.
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 in classes. 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 as 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.
Figure 1.1
Percentages of animals used by classes in the Member
States
Mice 60,96%
Artio+Perissodactyla
1,28%
Carnivores 0,25 %
Birds 5,88%
Cold-blooded animals
12,47%
Rabbits 3,12%
Other Rodents 0,47%
Guinea-Pigs 1,49%
Rats 13,96%
Prosimians+monkeys
+apes 0,05%
Other Mammals 0,07%
Rodents together with rabbits represent 80% of the total number of animals used. Mice
(60,9%) and rats (13,9%) 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 12,4%.
EN 8 EN
Birds is the next highest animal group used for experimental purposes at 5,9%.
The Artiodactyla and Perissodactyla group including horses, donkeys and cross-bred animals
(Perissodactyla), pigs, goats, sheep and cattle (Artiodactyla) represent only 1,2% of the total
number of animals used in the Member States.
Carnivores represent 0,25% of the total number of animals used and non-human primates
represent 0,05% of the animals used in 2011.
III.1.3. Comparison with the data of the previous reports
In this chapter, and the following chapters dealing with comparisons, it should be noted that
in 1996, 2002, 2005, 2008 and for this report France reported data respectively for 1997,
2001, 2004, 2007 and 2010 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 trends by comparing changes in proportions of use, expressed as a
percentage.
Comparison between proportions of classes of animals used in 1996, 1999, 2002,
2005, 2008 and 2011
Class of species 1996(*) 1999 2002(**) 2005(***) 2008(****) 2011(*****)
% Rodents-rabbits 81,3 86,9 78,0 77,5 82,2 80,0
% Cold-blooded animals 12,9 6,6 15,4 15, 9,6 12,4
% Birds 4,7 5 5,4 6,4 5,9
% Artio and Perissodactyla 1,2 1,2 1,1 1,4 1,2
(*) 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
(*****) 27 Member States reporting for 2011, one for 2010
The percentage of rodents and rabbits shows some fluctuation, but remains close to 80%. The
proportion of cold-blooded animals used in 1996, in 2002, in 2005 and 2008 is between 9,6 to
15%. However, in 1999 a much lower percentage of 6,6% was observed. In 2011, the use of
cold-blooded animals increased from the last report but the percentage of animals used seems
to fit perfectly into the cohort from 9,6 to 15% of the total number of animals.
Birds representing the third largest percentage of animals, seem to have reached a plateau in
2008. For the first time in 2011 the number of birds has decreased (by over
88 000). The group of horses, donkeys and cross-bred animals (Artiodactyla) and pigs, goats,
sheep and cattle (Perissodactyla) fluctuates at around 1%.
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 was
already a decrease reported in 2008 and for 2011 the decrease has continued (by more than
500 000 animals). However, the use of some individual species has increased. This is
displayed in Table 1.0 below.
Table 1.0 contains a comparison of the change that has taken place since 2008 for each
species, expressed by number of animals per species, between EU 27 (data from 2011) and
EU 27 (data from 2008) (first three columns) and in percentage per species (fourth column).
EN 9 EN
Table 1.0: Changes in species number and proportion between 2008 and 2011
Species
Number of
animals
in EU 27
2008
Number of
animals
in EU 27
2011
Change
since 2008
% change
by species
1.a Mice (Mus musculus) 7122188 6999312 -122876 -1,73
1.b Rats (Rattus norvegicus) 2121727 1602969 -518758 -24,45
1.c Guinea-Pigs (Cavia porcellus) 220985 171584 -49401 -22,35
1.d Hamsters (Mesocricetus ) 32739 25251 -7488 -22,87
1.e Other Rodents (other
Rodentia) 39506 28465 -11041 -27,95
1.f Rabbits (Oryctolagus
cuniculus) 333213 358213 25000 7,50
1.g Cats (Felis catus) 4088 3713 -375 -9,17
1.h Dogs (Canis familiaris) 21315 17896 -3419 -16,04
1.i Ferrets (Mustela putorius furo) 3208 2540 -668 -20,82
1.j Other Carnivores 2853 4982 2129 74,62
1.k Horses, donkeys and crossbreds
(Equidae) 5976 6686 710 11,88
1.l Pigs (Sus) 92813 77280 -15533 -16,74
1.m Goats (Capra) 3840 2907 -933 -24,30
1.n Sheep (Ovis) 30190 28892 -1298 -4,30
1.o Cattle (Bos) 33952 30914 -3038 -8,95
1.p Prosimians (Prosimia) 1261 83 -1178 -93,42
1.q New World Monkeys
(Ceboidea) 904 700 -204 -22,57
1.r Old World Monkeys
(Cercopithecoidea) 7404 5312 -2092 -28,25
1.s Apes (Hominoidea) 0 0 0 0,00
1.t Other Mammals (other
Mammalia) 5704 7888 2184 38,29
1.u Quail (Coturnix coturnix) 9626 5614 -4012 -41,68
1.v Other birds (other Aves) 754485 669451 -85034 -11,27
1.w Reptiles (Reptilia) 4101 3824 -277 -6,75
1.x Amphibians (Amphibia) 61789 29583 -32206 -52,12
1.y Fish (Pisces) 1087155 1397462 310307 28,54
1.z TOTAL 12001022 11481521 -519501 -4,33
There is a clear increase in the total numbers of five species out of the 25 species reported.
For other species a net decrease is observed.
The changes per species are reported in table 1.0 under the last column 'percentage change by
species' and in the column 'change since 2008' reflecting the magnitude of the change.
The highest increase is noted for fish used in comparison to 2008 (310 307).
There has been a significant proportional increase in the number of rabbits since 2008 (25
000).
For species used in lower numbers (i.e. in the thousands range) there is an increase in the
number of animals in the category other carnivores (2 129), horses, donkeys and cross-breds
(710) and other mammals (2 184).
The largest decrease observed in 2011 for species used in greater numbers (i.e. in the millions
range) is for rats with a reduction of more than 500 000 animals. In the same range there is
also a reduction in the use of mice (122 876). There is also a significant reduction in the use
of 'other birds' (more than 85 000) and guinea-pigs (49 401).
EN 10 EN
There is a clear decrease in the use of prosimians and non-human primates. The most notable
proportional reduction is in the use of prosimians (1 178) which represents a decrease of 94%.
The total number of new world monkeys is down from 904 in 2008 to 700 in 2011 (22,5%),
and use of old world monkeys has also decreased from 7 404 to
5 312 (28%).
No use of great apes has been reported in EU since in 1999.
Member States submitted a break down of the category 'other', for the following species:
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
(Gallus gallus domesticus).
EN 11 EN
Table 1.1: Total number of animals used for experimental purposes in the EU Member States
Data of 2011 (*)
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 SI SE UK Totals
1.a.Mice 153153 408883 3819 1328 72855 141991 26048 73503 1326274 1451046 24354 143755 248958 515946 6300 2131 470 0 237784 95115 24399 44575 634912 8747 11133 185913 1155920 6999312
1.b.Rats 9026 89547 2569 0 30829 67159 2556 18586 252589 312740 2266 70873 10476 155136 4020 1297 32 0 98881 38171 11290 5161 126406 5327 393 35202 252437 1602969
1.c. Guinea-
Pigs
3797 24300 3700 0 3304 4672 72 11 35543 24258 39 9228 545 13784 0 177 0 0 5493 8943 4 6607 13749 645 48 1151 11514 171584
1.d.
Hamsters
125 2435 516 0 119 178 120 201 8210 4187 88 0 517 0 0 0 0 3632 278 6 263 1492 0 0 881 2003 25251
1.e .Other
Rodents
64 421 1316 115 0 2682 224 4111 0 1946 0 979 11710 74 80 17 0 1483 3243 28465
1.f. Rabbits 15633 54001 822 0 7677 3602 3 357 125913 87303 701 7567 715 8392 0 274 0 0 6293 2198 102 2195 21302 299 234 710 11920 358213
1.g.Cats 14 630 8 0 181 0 0 454 569 585 19 34 120 0 0 0 0 0 174 480 0 229 10 0 34 172 3713
1.h.Dogs 75 490 0 0 1386 470 0 2805 3032 2474 4 675 473 408 9 0 0 0 692 229 20 0 1252 0 0 530 2872 17896
1.i Ferrets 12 192 0 0 193 129 0 0 351 96 0 0 0 0 0 0 0 852 0 0 87 0 0 76 552 2540
1.j. Other
Carnivores
0 0 45 197 0 656 0 262 0 0 0 430 2149 245 0 256 742 4982
1.k. Horses,
donkeys
and cross-
breds
128 54 595 67 40 23 373 1140 9 238 34 0 2371 766 14 346 7 107 374 6686
1.l.Pigs 1553 2622 110 2283 8694 325 681 7364 15090 390 1278 286 2486 19 0 14686 1147 474 2 11046 84 13 2277 4370 77280
1.m Goats 60 86 106 74 0 40 710 394 0 39 34 0 284 396 99 455 0 13 117 2907
1.n. Sheep 683 542 320 1147 191 0 684 5491 3287 8 160 348 243 0 2600 379 29 131 2790 14 4 285 9556 28892
1.o.Cattle 1582 810 783 513 6750 63 2362 4300 5 1700 27 0 2383 3489 3 1464 0 0 370 4310 30914
1.p.
Prosimians
0 0 0 0 0 0 0 0 83 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 83
1.q. NW
Monkeys
0 0 0 0 0 0 0 0 163 191 0 0 79 0 0 0 0 22 0 0 1 0 0 0 244 700
1.r. OW
Monkeys
0 20 0 0 30 0 0 0 1564 1579 7 0 371 0 0 0 0 184 0 0 342 0 0 0 1215 5312
1.s Apes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
1.t.Other
Mammals
0 64 2838 32 20 17 2 1154 0 480 184 10 41 594 56 0 1625 771 7888
1.u.Quail 0 651 0 0 230 0 0 0 122 2821 235 0 4 0 0 0 0 68 1247 9 105 88 0 0 34 5614
1.v.Other
birds
1940 16493 1080 170261 3245 701 4426 71821 31271 36304 503 29305 20 0 99354 13615 433 1196 21341 486 0 2804 162852 669451
1.w.Reptiles 0 459 1258 237 0 15 74 1011 0 239 0 133 15 0 0 0 383 3824
1.x
Amphibians
176 2113 4285 3989 115 0 73 3279 4453 220 725 21 894 149 0 1247 964 25 1097 0 1216 4542 29583
1.y.Fish 3267 60266 30 52771 51159 4400 30766 354039 119949 5236 88 51786 0 36034 100275 9601 61330 42 36108 420315 13974622
1.z.TOTAL 191288 665079 17259 1328 354196 282840 41035 136043 2200152 2073702 28001 276179 264990 781815 10329 4067 502 10 514617 282160 46556 60156 900127 15717 11874 271041 2050458 11481521
(*) France is reporting for 2010
EN 12 EN
Table 1.2: Classes of animals used for experimental purposes in the EU Member States
Data of 2011 (*)
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 SI SE UK Totals
Mice 153153 408883 3819 1328 72855 141991 26048 73503 1326274 1451046 24354 143755 248958 515946 6300 2131 470 0 237784 95115 24399 44575 634912 8747 11133 185913 1155920 6999312
Rats 9026 89547 2569 0 30829 67159 2556 18586 252589 312740 2266 70873 10476 155136 4020 1297 32 0 98881 38171 11290 5161 126406 5327 393 35202 252437 1602969
Guinea-Pigs 3797 24300 3700 0 3304 4672 72 11 35543 24258 39 9228 545 13784 0 177 0 0 5493 8943 4 6607 13749 645 48 1151 11514 171584
Hamsters+
other rodents
189 2856 516 0 1435 293 120 2883 8434 8298 0 88 0 2463 0 0 0 0 4611 11988 80 263 1572 17 0 2364 5246 53716
Rabbits 15633 54001 822 0 7677 3602 3 357 125913 87303 701 7567 715 8392 0 274 0 0 6293 2198 102 2195 21302 299 234 710 11920 358213
Cold-blooded
animals (1)
3443 62838 4315 0 58018 51511 4400 30854 357392 125413 220 5961 109 52919 0 149 0 0 37414 101254 9626 0 62427 0 42 37324 425240 1430869
Birds (2) 1940 17144 1080 0 170491 3245 701 4426 71943 34092 0 36539 503 29309 0 20 0 0 99422 14862 433 1205 21446 574 0 2804 162886 675065
Artio+Perissod
actyla (3)
4006 4114 430 0 4914 9539 7115 1491 16300 24211 398 1452 2611 2824 0 19 0 0 22324 6177 602 150 16101 98 24 3052 18727 146679
Carnivores 101 1312 8 0 1805 796 0 3915 3952 3417 23 709 593 408 9 0 0 0 2148 2858 20 0 1813 10 0 896 4338 29131
Prosimians+m
onkeys+apes
0 20 0 0 30 0 0 0 1810 1770 0 7 0 450 0 0 0 0 206 0 0 0 343 0 0 0 1459 6095
Other
Mammals
0 64 2838 32 20 17 2 1154 0 480 184 10 41 594 56 0 1625 771 7888
TOTAL 191288 665079 17259 1328 354196 282840 41035 136043 2200152 2073702 28001 276179 264990 781815 10329 4067 502 10 514617 282160 46556 60156 900127 15717 11874 271041 2050458 11481521
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 SI SE UK Totals
Mice 80,06 61,48 22,13 100,00 20,57 50,20 63,48 54,03 60,28 69,97 86,98 52,05 93,95 65,99 60,99 52,40 93,63 0,00 46,21 33,71 52,41 74,10 70,54 55,65 93,76 68,59 56,37 60,96
Rats 4,72 13,46 14,88 0,00 8,70 23,74 6,23 13,66 11,48 15,08 8,09 25,66 3,95 19,84 38,92 31,89 6,37 0,00 19,21 13,53 24,25 8,58 14,04 33,89 3,31 12,99 12,31 13,96
Guinea-Pigs 1,98 3,65 21,44 0,00 0,93 1,65 0,18 0,01 1,62 1,17 0,14 3,34 0,21 1,76 0,00 4,35 0,00 0,00 1,07 3,17 0,01 10,98 1,53 4,10 0,40 0,42 0,56 1,49
Hamsters + other rodents 0,10 0,43 2,99 0,00 0,41 0,10 0,29 2,12 0,38 0,40 0,00 0,03 0,00 0,32 0,00 0,00 0,00 0,00 0,90 4,25 0,17 0,44 0,17 0,11 0,00 0,87 0,26 0,47
Rabbits 8,17 8,12 4,76 0,00 2,17 1,27 0,01 0,26 5,72 4,21 2,50 2,74 0,27 1,07 0,00 6,74 0,00 0,00 1,22 0,78 0,22 3,65 2,37 1,90 1,97 0,26 0,58 3,12
Cold-blooded animals (1) 1,80 9,45 25,00 0,00 16,38 18,21 10,72 22,68 16,24 6,05 0,79 2,16 0,04 6,77 0,00 3,66 0,00 0,00 7,27 35,89 20,68 0,00 6,94 0,00 0,35 13,77 20,74 12,46
Birds (2) 1,01 2,58 6,26 0,00 48,13 1,15 1,71 3,25 3,27 1,64 0,00 13,23 0,19 3,75 0,00 0,49 0,00 0,00 19,32 5,27 0,93 2,00 2,38 3,65 0,00 1,03 7,94 5,88
Artio+Perissodactyla (3) 2,09 0,62 2,49 0,00 1,39 3,37 17,34 1,10 0,74 1,17 1,42 0,53 0,99 0,36 0,00 0,47 0,00 0,00 4,34 2,19 1,29 0,25 1,79 0,62 0,20 1,13 0,91 1,28
Carnivores 0,05 0,20 0,05 0,00 0,51 0,28 0,00 2,88 0,18 0,16 0,08 0,26 0,22 0,05 0,09 0,00 0,00 0,00 0,42 1,01 0,04 0,00 0,20 0,06 0,00 0,33 0,21 0,25
Prosimians+monkeys+apes 0,00 0,00 0,00 0,00 0,01 0,00 0,00 0,00 0,08 0,09 0,00 0,00 0,00 0,06 0,00 0,00 0,00 0,00 0,04 0,00 0,00 0,00 0,04 0,00 0,00 0,00 0,07 0,05
Other Mammals 0,00 0,01 0,00 0,00 0,80 0,01 0,05 0,01 0,00 0,06 0,00 0,00 0,18 0,02 0,00 0,00 0,00 100,00 0,01 0,21 0,00 0,00 0,01 0,00 0,00 0,60 0,04 0,07
TOTAL 100,00 100,00 100,00 100,0 100,00 100,00 100,00 100,00 100,00 100,00 100,00 100,00 100,00 100,00 100,00 100,0 100,00 100,00 100,00 100,00 100,00 100,00 100,00 100,00 100,00 100,00 100,00 100,00
FR(*) France reporting for 2010
(1) Reptiles + amphibians + fish
(2) Quails and Other birds
(3) Horses, donkeys, and cross-breds + pigs + goats and sheep + cattle
(4) Cats + dogs + ferrets + other carnivores
EN 13 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 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.
0%
20%
40%
60%
80%
100%
Mice
Rats
Guinea-Pigs
Hamsters
Rabbits
Cats
Dogs
Ferrets
Prosimians
NewWorldMonkeys
OldWorldMonkeys
Apes
Quail
Figure 1.2: Origin of species
Other countries
ETS 123 countries
EU countries
The chart indicates that the majority of species used in 2011 originate from EU breeding
centres. However, certain species such as cats, dogs, ferrets and old world monkeys
originated from both EU and non-EU breeding centres.
EN 14 EN
III.2.3. Comparison with data of the previous year
The general pattern shown in figure 1.2 on the origin of species remains rather similar to that
of previous reports, with clear preference for animals which are bred in the EU. There is an
increase in the use of dogs of EU origin from 72% to 85%, ferrets from 71% to 76% and old
world monkeys from 54% to 66%. However, there is a decrease in use of new world monkeys
from 99% to 92% and quails from 96% to 87% bred in the EU.
EN 15 EN
Table 1.3: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN
Data of 2011 (*)
1.1 Species 1.2 Total 1.3 Animals coming from
registered breeding or
supplying establishments
within the reporting country
1.4 Animals
coming from
elsewhere in the
EC
1.5 Animals coming from Member
Countries of the Council of Europe
which are parties to the Convention
ETS 123 (excluding EC Member
States)
1.6 Animals coming
from other origins
1.7 Re-used animals
1.a. Mice (Mus musculus) 6999312 5651922 900047 274313 173030 3768
1.b. Rats (Rattus norvegicus) 1602969 1253176 322045 13051 14697 3035
1.c. Guinea-Pigs (Cavia porcellus) 171584 120124 47311 3922 227 962
1.d. Hamsters (Mesocricetus ) 25251 18626 4676 0 1949 54
1.f. Rabbits (Oryctolagus cuniculus) 358213 336922 17009 1200 3082 15958
1.g. Cats (Felis catus) 3713 2299 379 34 1001 1181
1.h. Dogs (Canis familiaris) 17896 12246 3025 292 2333 4178
1.i. Ferrets (Mustela putorius furo) 2540 1035 893 40 572 64
1.p. Prosimians (Prosimia) 83 83 0 0 0 33
1.q. New World Monkeys (Ceboidea) 700 630 19 0 51 322
1.r. Old World Monkeys (Cercopithecoidea) 5312 1698 1813 5 1796 1492
1.s. Apes (Hominoidea) 0 0 0 0 0 0
1.u. Quail (Coturnix coturnix) 5614 4914 0 0 700 0
1.z. TOTAL 9193187 7403665 1297217 292857 199445
* France reporting for 2010
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 16 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 2011. 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
Biological studies of a
fundamental nature 46,1%
Research and develop
human +veterin+dentist
18,8%
Production and quality
control for products for
human medicine and
dentistry 10,97%
Production and quality
control of products for
veterinary medicine
2,94%
Toxicological and other
safety evaluation 8,75%
Education and training
1,56%
Other 9,27%
Diagnosis of disease 1,61%
More than 60% of animals were used for research and development in the fields of human
medicine, veterinary medicine, dentistry and in biological studies of fundamental nature.
Production and quality control of products and devices in human medicine, veterinary
medicine and dentistry required the use of 14% of the total number of animals.
Toxicological and other safety evaluation represents 8,75% of the total number of animals
used for experimental purposes.
Other purposes of procedures represents 9% 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,
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 since 2008 is that the number of animals used for research and
development for human medicine, dentistry and veterinary medicine has dropped, as it did
between 2005 and 2008. This time the drop is from 22,8% to 18,8% (in terms of animal
numbers the decrease is 575 518 animals). There is a reduction of more than
EN 17 EN
62 000 fish and 41 500 'other birds' whereas the percentage of animals used for fundamental
biological research has increased sharply from 38% to 46% (715 519 animals). Both
fundamental biological research and research and development in human and veterinary
medicine are the areas using by far the highest number of animals in the EU.
The number of animals used for toxicological and other safety evaluation amounts to 8,75%
of the total. This represents 1 004 873 animals in this report.
The decrease in the numbers of animals used for toxicological and other safety evaluations
since the report of 2008 is modest but represents nevertheless 37 280 animals.
The percentage of animals used for toxicology and safety evaluation was 9.9% in 2002, 8,2%
in 2005, 8,7% in 2008 and 8,75% for this report which indicates a trend of stability for this
area of use.
The number of animals used for production and quality control of devices for medicine,
veterinary medicine and dentistry has gone down by approximately 192 000. In spite of the
overall decrease, the use of rabbits has increased by more than 81 000 animals for production
and quality control of products and devices for human medicine and dentistry.
Further substantial increases since 2008 have been observed for mice (521 000) and fish (324
000) used in larger numbers for fundamental biological studies. There is also an increase in
the use of fish (above 83 000) and birds (above 10 000) for 'other experiments'.
Regarding the increase of mice for biological studies of fundamental nature, Member States
indicated that it was due to an increase in developmental assays and research using transgenic
mice as specific models for e.g. ocular research, bone metabolism and fertility. The type of
studies include LD50, ED50, potency testing and immunogenicity testing, studies in the area
of neuroscience, of immunology, studies on physiopathological mechanisms of tumours and
research to gain experience for the determination of mechanisms of action of diseases for
therapeutic purposes.
The increase use of fish in area of fundamental research was attributed to studies on fish
production, genetics, bio-molecular studies, cancer research, physiopathology and diagnosis.
Fish have also been used for neurology, cardiovascular studies and in selection according to
bioenergetic properties of their cardiac cells.
Fish increase in the category of 'other experiments' was attributed to single testing of biocides
and to telemetric monitoring of some common species in the environment. Fish are also
exclusively used under this heading by some Member States for vaccine studies.
Table 2.2 Number of animals used for selected purposes versus species
Species Biological
studies of a
fundamental
nature
Research,
development
and quality
control of
products and
devices for
human
medicine and
dentistry and
for veterinary
medicine
Toxicological
and other
safety
evaluations
(including
safety
evaluation of
products)
Diagnosis
of disease
Education
and
training
Other Total
Mice 3602370 2350205 464850 135042 82167 364381 6999015
Rats 491345 725109 272581 18295 48152 47589 1603266
Other rodents 36159 145153 28569 4527 4234 6658 225300
Rabbits 12648 253488 23185 6083 2068 60741 358213
Carnivores 8733 8706 7873 1905 1149 798 29164
Artio+Perissodactyla 51876 48240 5221 7558 14297 19454 146646
Prosimians+monkeys+apes 631 1375 3435 0 209 445 6095
EN 18 EN
Other mammals 6822 773 179 53 26 35 7888
Birds 294768 191575 17202 7480 3025 161015 675065
Cold-blooded animals 785221 31373 181778 4314 24654 403529 1430869
TOTAL 5290573 3755997 1004873 185257 179981 1064645 11481521
Figure 2.2 presents the number of animals used for selected purposes by classes of species.
The highest number of mice and rats used is attributed to biological studies of a fundamental
nature and research, development and quality control of products and devices for medicine,
dentistry and veterinary medicine. There has been an increase in the number of cold-blooded
animals (essentially fish) used for other purposes and also for biological studies of
fundamental nature since 2008.
EN 19 EN
Mice(Musmusculus)
Rats(Rattusnorvegicus)
OtherRodents
Rabbits(Oryctolaguscuniculus)
Carnivores
Artio+Perissodactyla
Prosimians+monkeys+apes
OtherMammals
Birds
Cold-bloodedanimals
Biological studies of a fundamental nature
Research,development and quality control of products and
devices for human medicine and dentistry and for veterinary
medicine
Toxicological and other safety evaluations (including safety
evaluation of products)
Diagnosis of disease
Education and training
Other
0
500000
1000000
1500000
2000000
2500000
3000000
3500000
4000000
Figure 2.2
Species and experimental purposes
N 20 EN
Table 2.1: Number of animals used in experiments for selected purposes
Purposes versus species
data of 2011*
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) 3602370 1458291 781514 110400 464850 135042 82167 364381 6999015
1.b. Rats (Rattus norvegicus) 491345 549341 157145 18623 272581 18295 48152 47589 1603266
1.c. Guinea-Pigs (Cavia porcellus) 8426 25777 86142 16350 26722 2067 3293 2807 171584
1.d. Hamsters (Mesocricetus ) 5605 8230 125 5876 1547 408 440 3020 25251
1.e. Other Rodents (other Rodentia) 22128 2653 0 0 300 2052 501 831 28465
1.f. Rabbits (Oryctolagus cuniculus) 12648 19434 212043 22011 23185 6083 2068 60741 358213
1.g. Cats (Felis catus) 855 885 81 223 325 981 169 194 3713
1.h. Dogs (Canis familiaris) 3715 4671 65 927 7488 458 351 221 17896
1.i. Ferrets (Mustela putorius furo) 927 1223 86 4 28 9 79 217 2573
1.j. Other Carnivores (other Carnivora) 3236 0 0 541 32 457 550 166 4982
1.k. Horses, donkeys and cross-breds
(Equidae) 1449 868 235 2522 122 902 168 387 6653
1.l. Pigs (Sus) 24084 20806 839 6841 3537 3067 10022 8084 77280
1.m. Goats (Capra) 783 535 159 6 8 187 358 871 2907
1.n. Sheep (Ovis) 9816 2643 4250 2126 746 1854 1206 6251 28892
1.o. Cattle (Bos) 15744 3228 251 2931 808 1548 2543 3861 30914
1.p. Prosimians (Prosimia) 83 0 0 0 0 0 0 0 83
1.q. New World Monkeys (Ceboidea) 244 221 79 0 44 0 0 112 700
1.r. Old World Monkeys
(Cercopithecoidea) 304 937 138 0 3391 0 209 333 5312
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0 0 0
1.t. Other Mammals (other Mammalia) 6822 531 4 238 179 53 26 35 7888
1.u. Quail (Coturnix coturnix) 1591 0 0 0 3094 9 80 840 5614
1.v. Other birds (other Aves) 293177 36178 16855 138542 14108 7471 2945 160175 669451
1.w. Reptiles (Reptilia) 3202 98 0 0 0 412 111 1 3824
1.x. Amphibians (Amphibia) 16489 946 0 0 2695 5 9127 321 29583
1.y. Fish (Pisces) 765530 20692 0 9637 179083 3897 15416 403207 1397462
1.z. TOTAL 5290573 2158188 1260011 337798 1004873 185257 179981 1064645 11481521
(*) France is reporting for 2010
EN 21 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 2011 is presented in table 3 at the
end of this chapter. In this table 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
3.5 Products/ substances used
or intended to be used mainly in
the household
0,01%
3.6 Products/ substances used
or intended to be used mainly as
cosmetics or toiletries
0,24%
3.7 Products/ substances used
or intended to be used mainly as
additives in food for human
consumption
0,10%
3.4 Products/ substances used
or intended to be used mainly in
industry
7,79%
3.3 Products/ substances
used or intended to be used
mainly in agriculture
8,07%
3.2 Products/ substances or
devices for human medicine and
dentistry and for veterinary
medicine
39,79%
3.8 Products/ substances used
or intended to be used mainly as
additives in food for animal
consumption
0,46%
3.9 Potential or actual
contaminents in the general
environment which do not appear
in other columns
9,19%
3.10 Other toxicological or
safety evaluations
34,35%
The number of animals used for toxicological and other safety evaluation for different
products, or for testing potential contaminants to the environment amounts to 1 004 873
which represents only 8,75% of the total number of animals used for scientific purposes in
2011 (see table 2.1, column 2.6).
Toxicological or other safety evaluations are split 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 (0,35%) when compared to the other product groups.
Products or devices used for human medicine, veterinary medicine and dentistry represents
39,8% of the animals used for toxicological or other safety evaluations.
EN 22 EN
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 15,9% of the animals for toxicological and other
safety evaluations.
There is little change with regard to the number of animals used for toxicological tests for
products intended for industry and for agriculture in comparison to 2008, but there is a net
increase of the number of animals used for potential contaminants of the environment. The
increase is from above 65 000 to approximately 92 000.
A significant decrease has been observed in the number of animals used for testing food for
animal consumption in comparison to 2008 from 54 000 to 4 600 which is more than a tenfold
decrease but also for cosmetics and toiletries where the decrease is from 1 960 to 90
animals. This is important to highlight as there is a testing ban in the EU for cosmetics and
cosmetic ingredients in place since 2009.
There is, however, a substantial increase in the number of animals used for tests for 'other
toxicological or safety evaluations' from 223 000 to 345 000 animals (roughly 122 000
animals which represent an increase of 54%). An increase was also observed in the 2008
report. Member States reported that under this heading, animals are used in metabolic studies
and preclinical research, testing substances and products in human and veterinary medicine
and in teratology studies on. They are also used in toxicity test to aquatic vertebrates not
included in other categories, in LD50, ED50, pyrogen testing, and testing for algae biotoxins
and other foodstuff contaminants.
EN 23 EN
Table 3: Number of animals used in toxicological and other safety evaluation
Products versus species
Data of 2011*
3.1 Species 3.2 Products/
substances or
devices for
human
medicine and
dentistry and for
veterinary
medicine
3.3 Products/
substances
used or
intended to be
used mainly in
agriculture
3.4 Products/
substances
used or
intended to
be used
mainly in
industry
3.5 Products/
substances
used or
intended to
be used
mainly in the
household
3.6 Products/
substances
used or
intended to
be used
mainly as
cosmetics or
toiletries
3.7 Products/
substances
used or
intended to be
used mainly as
additives in
food for human
consumption
3.8 Products/
substances
used or
intended to be
used mainly as
additives in food
for animal
consumption
3.9 Potential
or actual
contaminants
in the general
environment
which do not
appear in
other
columns
3.10 Other
toxicological or
safety
evaluations
3.11 Total
1.a. Mice (Mus musculus) 140441 15395 20073 40 40 652 1156 1910 285003 464710
1.b. Rats (Rattus norvegicus) 146109 35867 47684 804 50 1502 196 4323 36186 272721
1.c. Guinea-Pigs (Cavia porcellus) 19132 2180 872 76 0 0 7 0 4455 26722
1.d. Hamsters (Mesocricetus ) 1121 73 151 8 0 0 0 0 194 1547
1.e. Other Rodents (other Rodentia) 70 48 0 0 0 0 0 0 182 300
1.f. Rabbits (Oryctolagus cuniculus) 14616 2012 2373 49 0 0 16 4 4115 23185
1.g. Cats (Felis catus) 325 0 0 0 0 0 0 0 0 325
1.h. Dogs (Canis familiaris) 6260 247 0 0 0 0 0 0 981 7488
1.i. Ferrets (Mustela putorius furo) 28 0 0 0 0 0 0 0 0 28
1.j. Other Carnivores (other Carnivore) 32 0 0 0 0 0 0 0 0 32
1.k. Horses, donkeys and cross-breds
(Equidae) 122 0 0 0 0 0 0 0 0 122
1.l. Pigs (Sus) 2589 5 0 0 0 0 196 152 595 3537
1.m. Goats (Capra) 0 8 0 0 0 0 0 0 0 8
1.n. Sheep (Ovis) 569 0 0 0 0 0 21 140 16 746
1.o. Cattle (Bos) 732 19 0 0 0 0 6 0 51 808
1.p. Prosimians (Prosimia) 0 0 0 0 0 0 0 0 0 0
1.q. New World Monkeys (Ceboidea) 38 0 0 0 0 0 0 0 6 44
1.r. Old World Monkeys
(Cercopithecoidea) 2589 0 0 0 0 0 0 0 802 3391
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0 0 0 0
1.t. Other Mammals (other Mammalia) 0 0 0 0 0 0 0 0 0 0
1.u. Quail (Coturnix coturnix) 0 2859 0 0 0 0 0 0 235 3094
1.v. Other birds (other Aves) 8558 1775 0 0 0 0 3006 64 884 14287
1.w. Reptiles (Reptilia) 0 0 0 0 0 0 0 0 0 0
1.x. Amphibians (Amphibia) 0 336 0 0 0 0 0 2340 19 2695
1.y. Fish (Pisces) 56463 20255 7163 0 0 276 0 83433 11493 179083
1.z. TOTAL 399794 81079 78316 977 90 2430 4604 92366 345217 1004873
(*) France reporting for 2010
EN 24 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 of 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 2011 the number of animals used for the study of both animal and human diseases
represented 6 599 320 animals which is more than half (57%) the total number of animals
used for scientific purposes in the EU.
Figure 4.1 presents the percentage of animals used in studies per type of disease, 90% of
which are used for the study of human diseases.
Figure 4.1
Proportion of animals used for studies of diseases
Other human diseases
45,97% Human cancer
(excluding evaluations
of carcino hazards )
16,76%
Human nervous and
mental disorders
20,2%
Human cardiovascular
diseases
7,88%
Specific to animal
diseases
9,19%
In 2011, the overall number of animals used for studies on human and animal diseases has
increased to a little more than 276 000 animals. The use of animals for specific studies on
animal diseases in 2011 (which had a decrease of 50% in 2008) is comparatively unchanged
from the 2008 report. There is a reduction in the use of cold-blooded animals by just under 22
500.
It is important to note that there has been a net increase of more than 115 000 animals used for
studies on cardiovascular diseases, and of more than 250 000 for human cancer studies.
In comparison to 2008, increases of the use of animals have also been observed for dogs,
totalling above 1 000; for other carnivores about 500; for other mammals a little above 300
and for other birds above 2 500.
On the other hand, the number of rats used for studies on diseases has decreased by more than
250 000 animals.
EN 25 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 2011 *
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) 373188 872698 1049177 2106651 303009 4702052
1.b. Rats (Rattus norvegicus) 118848 409386 36156 438491 5337 1008156
1.c. Guinea-Pigs (Cavia porcellus) 2880 1893 44 27472 2373 34662
1.d. Hamsters (Mesocricetus ) 3000 398 779 5517 3269 12963
1.e. Other Rodents (other Rodentia) 1713 912 0 4723 2830 10178
1.f. Rabbits (Oryctolagus cuniculus) 5208 825 2852 24023 4523 37424
1.g. Cats (Felis catus) 2 64 4 217 2026 2313
1.h. Dogs (Canis familiaris) 860 79 187 3360 6543 11029
1.i. Ferrets (Mustela putorius furo) 0 156 0 2175 55 2386
1.j. Other Carnivores (other Carnivore) 19 0 0 538 1035 1592
1.k. Horses, donkeys and cross-breds
(Equidae)
1 0 0 135 2083 2219
1.l. Pigs (Sus) 6118 527 227 8743 16278 31893
1.m. Goats (Capra) 72 15 54 604 281 1026
1.n. Sheep (Ovis) 897 93 23 10683 3032 14728
1.o. Cattle (Bos) 220 0 0 2960 6507 9687
1.p. Prosimians (Prosimia) 0 58 0 25 0 83
1.q. New World Monkeys (Ceboidea) 15 171 0 385 0 571
1.r. Old World Monkeys (Cercopithecoidea) 369 88 61 1746 45 2309
1.s. Apes (Hominoidea) 0 0 0 0 0 0
1.t. Other Mammals (other Mammalia) 0 154 18 833 700 1705
1.u. Quail (Coturnix coturnix) 0 640 0 244 4 888
1.v. Other birds (other Aves) 1037 2302 100 20365 204069 227873
1.w. Reptiles (Reptilia) 0 39 0 407 695 1141
1.x. Amphibians (Amphibia) 549 393 180 6066 949 8137
1.y. Fish (Pisces) 4814 45004 16059 367640 40788 474305
1.z. TOTAL 519810 1335895 1105921 3034003 606431 6599320
* France reporting for 2010
EN 26 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 373188 872698 1049177 2106651 303009 4702052
Rats 118848 409386 36156 438491 5337 1008156
Guinea-Pigs 2880 1893 44 27472 2373 34662
Other Rodents 4713 1310 779 10240 6099 23141
Rabbits 5208 825 2852 24023 4523 37424
Carnivores 881 299 191 6290 9659 17320
Artio + Perissodactyla 7308 635 304 23125 28181 59553
Prosimians+Monkeys+Apes 384 317 61 2156 45 2963
Other Mammals 0 154 18 833 700 1705
Birds 1037 2942 100 20609 204073 228761
Cold-blooded animals 5363 45436 16239 374113 42432 483583
TOTAL 519810 1335895 1105921 3034003 606431 6599320
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 7,94 18,56 22,31 44,80 6,44 100,00
Rats 11,79 40,61 3,59 43,49 0,53 100,00
Guinea-Pigs 8,31 5,46 0,13 79,26 6,85 100,00
Other Rodents 20,37 5,66 3,37 44,25 26,36 100,00
Rabbits 13,92 2,20 7,62 64,19 12,09 100,00
Carnivores 5,09 1,73 1,10 36,32 55,77 100,00
Artio + Perissodactyla 12,27 1,07 0,51 38,83 47,32 100,00
Prosimians+Monkeys+Apes 12,96 10,70 2,06 72,76 1,52 100,00
Other Mammals 0,00 9,03 1,06 48,86 41,06 100,00
Birds 0,45 1,29 0,04 9,01 89,21 100,00
Cold-blooded animals 1,11 9,40 3,36 77,36 8,77 100,00
EN 27 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 shows the proportion of animals used by classes per type of studies of diseases.
0%
20%
40%
60%
80%
100%
Mice
Rats
Guinea-Pigs
OtherRodents
Rabbits
Carnivores
Artio+Perrisodactyla
Prosimians+Monkeys+Apes
OtherMammals
Birds
Cold-bloodedanimals
Figure 4.2
Proportion of animals used by classes per type of studies of diseases
Specific to animal diseases
Other human diseases
Human cancer (excluding evaluations
of carcino hazards )
Human nervous and mental disorders
Human cardiovascular diseases
The top of each bar shows the relative percentage of animals used for studies on specific
animal diseases. For this category a significant decrease in numbers of both Artiodactyla and
Perissodactyla, has been recorded. However, an increase in the numbers of carnivores was
observed for the same purpose.
In addition to the year 2011 having been relatively quiet from a zoo-sanitary point of view,
and thus the pressure for testing in farm animals relatively low, other reasons indicated by
Member States for a decrease in this area include
- reduction of livestock housing capacity;
- move away from large animal-based to more basic laboratory-based bioscience type studies
(on tissue culture, cell lines etc. rather than animal type studies);
- as larger animals models are particularly expensive to run, it was suggested that they may
have become unsustainable for some laboratories;
- larger animal models are normally used just before going into clinical trials and as such are
cyclical.
Regarding the increased use of carnivores Member States indicated that these animals have
been used in veterinary clinical trials, studies on genetic diseases, for research and
development of products and devices for veterinary medicine and for vaccine studies (e.g.
leishmania).
The data on the use of most species for all types of studies on both human and animal diseases
show a similarity to the report of 2008. However, there is a substantial decrease in the use of
'other rodents' for studies of human diseases in particular 'human nervous and mental
disorders'.
EN 28 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 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 13,9% of the total
number of animals used for experimental purposes in 2011. 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
3,9
35,9
0,13
2,73
47,11
10,23
0 10 20 30 40 50
5.2 National legislation specific
to a single EC Member State
5.3 EC legislation including
European Pharmacopoeia
(requirements)
5.4 Member Country of Council
of Europe (but not EC) legislation
5.5 Other legislation
5.6 Any combination of 5.2/
5.3/ 5.4/ 5.5
5.7 No regulatory
requirements
The largest proportion of animals in this area (47%) was used to simultaneously satisfy
requirements from several pieces of legislation emanating from the EU, the Council of
Europe, from national legislation and from legislation outside of the EU. The testing carried
out to satisfy EU legislation including the European Pharmacopoeia covered 35,9% of the
animals used in this area.
In comparison to the report of 2008 it is important to note that there is an increase in the
number of animals used for 'no regulatory requirements'.
It should also be noted that, there is a slight increase in the number of animals used to satisfy
national legislation, despite the fact that there is a net reduction of the total number of animals
used in this sector (192 000).
EN 29 EN
Table 5 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 2011 *
5.1 Species 5.2 National
legislation specific
to a single EC
Member State (1)
5.3 EC legislation
including European
Pharmacopoeia
(requirements)
5.4 Member
Country of Council
of Europe (but not
EC) legislation (2)
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) 48385 250338 2162 33046 486522 71461 891914
1.b. Rats (Rattus norvegicus) 3962 69859 0 4477 93887 3583 175768
1.c. Guinea-Pigs (Cavia porcellus) 1406 35856 0 4836 54984 5278 102492
1.d. Hamsters (Mesocricetus ) 0 1667 0 0 4334 0 6001
1.e. Other Rodents (other Rodentia) 0 0 0 0 0 0 0
1.f. Rabbits (Oryctolagus cuniculus) 1628 96730 13 880 71826 62757 234054
1.g. Cats (Felis catus) 0 265 0 0 38 1 304
1.h. Dogs (Canis familiaris) 118 597 0 0 262 15 992
1.i. Ferrets (Mustela putorius furo) 0 0 0 0 32 58 90
1.j. Other Carnivores (other Carnivore) 19 213 0 0 0 309 541
1.k. Horses, donkeys and cross-breds (Equidae) 338 231 0 0 105 2083 2757
1.l. Pigs (Sus) 324 3694 15 0 2465 774 7382
1.m. Goats (Capra) 0 448 0 0 6 9 463
1.n. Sheep (Ovis) 109 1651 0 4 691 3901 6376
1.o. Cattle (Bos) 64 1806 0 4 741 546 3161
1.p. Prosimians (Prosimia) 0 21 0 0 0 0 21
1.q. New World Monkeys (Ceboidea) 0 0 0 0 79 0 79
1.r. Old World Monkeys (Cercopithecoidea) 0 0 0 0 138 0 138
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0
1.t. Other Mammals (other Mammalia) 0 0 0 0 56 4 60
1.u. Quail (Coturnix coturnix) 0 0 0 0 0 0 0
1.v. Other birds (other Aves) 3811 106761 0 385 36585 8037 155579
1.w. Reptiles (Reptilia) 0 0 0 0 0 0 0
1.x. Amphibians (Amphibia) 0 0 0 0 0 0 0
1.y. Fish (Pisces) 1600 3296 0 0 0 4741 9637
1.z. TOTAL 61764 573433 2190 43632 752751 163557 1597809
(*) France reporting for 2010
Examples: 5.2 - France is testing due to a UK (or FR) specific requirement Note: columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out
5.3 - UK is testing according to EC legislation and not to the body which has issued the actual test method, guideline or protocol
5.4 - Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an
5.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be
5.6 - Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 5.2 in the tables submitted by Belgium.
Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech 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 30 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 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 8,75% of the total number of animals used for experimental purposes in the EU.
Figure 6
Percentages of animals used for regulatory requirements for toxicological and other
safety evaluation
8,96
21,27
0,16
2,38
56,17
11,06
0 10 20 30 40 50 60
6.2 National legislation
specific to a single EC Member
State
6.3 EC legislation including
European Pharmacopoeia
(requirements)
6.4 Member Country of Council
of Europe (but not EC) legislation
6.5 Other legislation
6.6 Any combination of 5.2/
5.3/ 5.4/ 5.5
6.7 No regulatory
requirements
Animals used to simultaneously satisfy regulatory requirements from several pieces of
legislation represent 56% of the animals used in this area. The testing required under EU
legislation including the European Pharmacopoeia accounts for the second highest percentage
in this area, namely 21,27%.
The percentage of the use of animals to satisfy requirements of different legislation has
increased from fewer than 50% to more than 56%.
There is also a decrease in the number of animals used for 'no regulatory requirements'.
In addition to the examples of the type of testing reported under 'no regulatory requirements'
in the last report (namely those of in-house methods to verify the safety and efficacy of
veterinary biologicals and medicinal products carried according to company’s or known
EN 31 EN
international standards), Member States reported preliminary studies for trial of doses,
optimisation of numbers and candidates, and probing mechanism of action of toxicities
associated with clinically approved drugs or combination studies involving clinically
approved drugs.
EN 32 EN
Table 6: Number of animals used in toxicological and other safety evaluations
Regulatory requirements versus species
Data of 2011*
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) 33212 105801 361 5263 299377 20836 464850
1.b. Rats (Rattus norvegicus) 17657 44614 924 10481 183446 15459 272581
1.c. Guinea-Pigs (Cavia porcellus) 817 14340 37 1466 8503 1559 26722
1.d. Hamsters (Mesocricetus ) 149 278 0 174 946 0 1547
1.e. Other Rodents (other Rodentia) 4 70 0 0 191 35 300
1.f. Rabbits (Oryctolagus cuniculus) 1211 8685 257 1481 10796 525 22955
1.g. Cats (Felis catus) 68 283 0 0 76 16 443
1.h. Dogs (Canis familiaris) 737 1011 0 603 5024 107 7482
1.i. Ferrets (Mustela putorius furo) 0 118 0 0 20 0 138
1.j. Other Carnivores (other Carnivore) 0 8 0 0 0 0 8
1.k. Horses, donkeys and cross-breds
(Equidae) 60 65 0 0 18 0 143
1.l. Pigs (Sus) 36 1292 0 307 1691 95 3421
1.m. Goats (Capra) 0 127 0 0 8 0 135
1.n. Sheep (Ovis) 320 58 0 69 159 140 746
1.o. Cattle (Bos) 238 89 0 0 436 24 787
1.p. Prosimians (Prosimia) 0 21 0 0 0 0 21
1.q. New World Monkeys (Ceboidea) 0 11 0 0 20 13 44
1.r. Old World Monkeys (Cercopithecoidea) 221 234 0 348 2558 30 3391
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0
1.t. Other Mammals (other Mammalia) 0 0 0 0 0 0 0
1.u. Quail (Coturnix coturnix) 45 380 0 0 2669 0 3094
1.v. Other birds (other Aves) 591 9654 0 0 3696 346 14287
1.w. Reptiles (Reptilia) 0 0 0 0 0 0 0
1.x. Amphibians (Amphibia) 0 0 0 0 1539 1156 2695
1.y. Fish (Pisces) 34625 26566 0 3762 43305 70825 179083
1.z. TOTAL 89991 213705 1579 23954 564478 111166 1004873
(*) France is reporting for 2010
Examples: 6.2 - France is testing due to a UK (or FR) specific requirement Note:
6.3 - UK is testing according to EC legislation
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and not to the
body which has issued the actual test method, guideline or protocol
6.4 - Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an
6.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be
6.6 - Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 6.2 in the tables submitted by Belgium.
Footnotes:1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech 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.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 effects in table 7.2. A graph
showing the percentage of animals used per toxicity test groups in 2011 is presented in figure 7.
Figure 7
Percentages of animals used in toxicity tests for toxicological
and other safety evaluation
47,50
3,89
7,97
3,30
11,35
3,92
22,06
0,00 10,00 20,00 30,00 40,00 50,00
Acute and sub-acute toxicity
testing methods (including limit
test)
Irritation /sensitization tests
Sub- chronic and chronic
toxicity
Mutagenicity and
carcinogenicity
Reproductive and
developmental toxicity
Toxicity to aquatic vertebrates
not included in other columns
other
As pointed out in the previous chapter, the number of animals used in toxicological and other
safety evaluations represents 8,75% of the total number of animals used for experimental
purposes.
In figure 7 the largest percentage (47,5%) of use of animals is due to acute and sub-acute toxicity
tests. Taking into account sub-chronic and chronic toxicity, the percentage of animals used in
short- and long-term systemic toxicity testing accounts for 55% of the total number of animals
used in this area.
Nearly 15% animals were used for testing carcinogenicity, mutagenicity and toxicity to
reproduction. Another important category of use of animals in 2011 is for 'other tests' with 22%.
In addition to the type of testing reported under 'other toxicological and safety evaluation' in the
previous report (namely those of neurotoxicity, toxicokinetics, testing of biological evaluation of
medical devices: intracutaneous testing of reactivity in rabbits, studies into the penetration of
nanoparticles through tissue and their biocompatibility, studies into the evaluation of
EN 34 EN
sensitization potential of dyestuffs used in the textile industry and pharmacological studies
included in safety tests), Member States reported that this heading covered also target animal
studies carried out on companion animals to different regulatory standards e.g. US EPA, FDA,
tests to determine the residues of veterinary medicaments in calves and in broilers, test to
determine the non-toxicity and irreversibility of toxins and efficacy of vaccines (blue tongue,
clostridium).
By looking both at 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 four reports of the proportion of animals used for
acute and sub-acute tests, from 36%, 42%, 45% to 47,5% respectively. This represents in animal
numbers an increase of more than 8 400 animals since the last report.
Contrary to the previous three reports where a steady decrease was observed, for 2011 the
number of the animals used for reproductive toxicity testing has increased from 9% in 2008 to
11,35%. In terms of animal numbers it means an increase of almost 19 000 animals.
EN 35 EN
Table 7.1 Number of animals used in toxicological and other safety evaluations
Type of tests versus species
Data of 2011*
7.1 Species 7.2 Acute and sub-acute toxicity testing
methods (including limit test)
7.3 Skin
irritation
7.4 Skin
sensitisa
tion
7.5 Eye
irritation
7.6 Sub-
chronic
and
chronic
toxicity
7.7
Carcino-
genicity
7.8
Develop-
mental
toxicity
7.9
Muta-
genicity
7.10
Repro-
ductive
toxicity
7.11
Toxicity
to
aquatic
vertebrates
not
included
in other
columns
7.12
Other
7.13 Total
7.2.1.
LD50,
LC50
7.2.2.
Other
lethal
methods
7.2.3. Non
lethal clinical
signs
methods
1.a. Mice (Mus musculus) 220544 51356 43637 64 16846 30 16436 5271 1188 9931 742 0 98796 464841
1.b. Rats (Rattus norvegicus) 8376 10870 65185 1490 64 0 42274 6445 20189 11278 61209 0 45200 272508
1.c. Guinea-Pigs (Cavia porcellus) 773 1847 1546 88 15214 0 1630 110 0 0 254 0 5270 26732
1.d. Hamsters (Mesocricetus ) 0 0 210 11 0 0 489 0 0 50 0 0 857 1617
1.e. Other Rodents (other Rodentia) 182 4 0 0 0 0 0 0 0 0 0 0 274 460
1.f. Rabbits (Oryctolagus cuniculus) 15 143 2947 3151 44 2080 634 0 2560 0 2978 0 8515 23067
1.g. Cats (Felis catus) 0 0 34 0 0 0 12 0 0 0 0 0 285 331
1.h. Dogs (Canis familiaris) 0 123 2469 0 0 0 2785 0 0 0 95 0 1903 7375
1.i. Ferrets (Mustela putorius furo) 0 0 0 0 0 0 0 0 0 0 0 0 52 52
1.j. Other Carnivores (other
Carnivore) 0 0 0 0 0 0 0 0 0 0 0 0 11 11
1.k. Horses, donkeys and crossbreds
(Equidae) 0 0 33 0 0 0 0 0 60 0 0 0 148 241
1.l. Pigs (Sus) 0 39 807 45 0 0 729 0 22 0 86 0 1682 3410
1.m. Goats (Capra) 0 0 0 0 0 0 0 0 0 0 0 0 8 8
1.n. Sheep (Ovis) 0 0 0 0 0 0 30 0 299 0 0 0 438 767
1.o. Cattle (Bos) 0 0 45 0 0 0 24 0 230 0 0 0 488 787
1.p. Prosimians (Prosimia) 0 0 0 0 0 0 0 0 0 0 0 0 0 0
1.q. New World Monkeys (Ceboidea) 0 0 24 0 0 0 0 0 0 0 0 0 20 44
1.r. Old World Monkeys
(Cercopithecoidea) 0 0 877 0 0 0 1306 0 266 0 15 0 927 3391
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0 0 0 0 0 0 0 0
1.t. Other Mammals (other
Mammalia) 0 0 0 0 0 0 0 0 0 0 0 0 0 0
1.u. Quail (Coturnix coturnix) 329 370 0 0 0 0 45 0 0 0 0 0 2350 3094
1.v. Other birds (other Aves) 423 182 4584 0 0 0 0 50 0 0 556 0 8492 14287
1.w. Reptiles (Reptilia) 0 0 0 0 0 0 0 0 0 0 0 0 0 0
1.x. Amphibians (Amphibia) 0 0 1660 0 0 0 0 0 500 0 0 516 19 2695
1.y. Fish (Pisces) 34137 11641 11898 0 0 0 13730 0 16468 29 6381 38890 45909 179083
1.z. TOTAL 264779 76575 135956 4849 32168 2110 80124 11876 41782 21288 72316 39406 221644 1004873
(*) France reporting for 2010
EN 36 EN
Table 7.2 Grouping of certain type of tests on animals of table 7.1
7.1 Species Acute and sub-acute
toxicity testing methods
(including limit test)
Irritation
/sensitization
tests
Sub- chronic and
chronic toxicity
Mutagenicity and
carcinogenicity
Reproductive
and
developmental
toxicity
Toxicity to
aquatic
vertebrates not
included in other
columns
Other Total
1.a. Mice (Mus musculus) 315537 16940 16436 15202 1930 0 98796 464841
1.b. Rats (Rattus norvegicus) 84431 1554 42274 17723 81398 0 45200 272508
1.c. Guinea-Pigs (Cavia porcellus) 4166 15302 1630 110 254 0 5270 26732
1.d. Hamsters (Mesocricetus ) 210 11 489 50 0 0 857 1617
1.e. Other Rodents (other Rodentia) 186 0 0 0 0 0 274 460
1.f. Rabbits (Oryctolagus cuniculus) 3105 5275 634 0 5538 0 8515 23067
1.g. Cats (Felis catus) 34 0 12 0 0 0 285 331
1.h. Dogs (Canis familiaris) 2592 0 2785 0 95 0 1903 7375
1.i. Ferrets (Mustela putorius furo) 0 0 0 0 0 0 52 52
1.j. Other Carnivores (other Carnivore) 0 0 0 0 0 0 11 11
1.k. Horses, donkeys and cross-breds
(Equidae) 33 0 0 0 60 0 148 241
1.l. Pigs (Sus) 846 45 729 0 108 0 1682 3410
1.m. Goats (Capra) 0 0 0 0 0 0 8 8
1.n. Sheep (Ovis) 0 0 30 0 299 0 438 767
1.o. Cattle (Bos) 45 0 24 0 230 0 488 787
1.p. Prosimians (Prosimia) 0 0 0 0 0 0 0 0
1.q. New World Monkeys (Ceboidea) 24 0 0 0 0 0 20 44
1.r. Old World Monkeys (Cercopithecoidea) 877 0 1306 0 281 0 927 3391
1.s. Apes (Hominoidea) 0 0 0 0 0 0 0 0
1.t. Other Mammals (other Mammalia) 0 0 0 0 0 0 0 0
1.u. Quail (Coturnix coturnix) 699 0 45 0 0 0 2350 3094
1.v. Other birds (other Aves) 5189 0 0 50 556 0 8492 14287
1.w. Reptiles (Reptilia) 0 0 0 0 0 0 0 0
1.x. Amphibians (Amphibia) 1660 0 0 0 500 516 19 2695
1.y. Fish (Pisces) 57676 0 13730 29 22849 38890 45909 179083
1.z. TOTAL 477310 39127 80124 33164 114098 39406 221644 1004873
EN 37 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.
III.9.2. Treatment and interpretation of the data
As pointed out earlier, animals used in toxicological and other safety evaluation represent
8,75% 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. 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.
Figure 8 gives the proportion of animals used for toxicity and other safety evaluation by types
of products.
0% 20% 40% 60% 80% 100%
Acute and sub-acute toxicity testing
methods (including limit test)
Irritation/sensitization tests
Sub- chronic and chronic toxicity
Carcinogenicity, Mutagenicity and Reprotox
Toxicity to aquatic vertebrates not included in
other columns
Other
Figure 8
Proportion of animals used for toxicity tests for toxicological and other safety
evaluation by type 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
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' and for 'other
toxicological and safety evaluation'. For irritation/sensitization properties and for
carcinogenicity/mutagenicity and reprotox the three categories of uses; human medicine,
agriculture and industrial products show a similar pattern of use of animals. Whereas the
largest number of animals used in sub-chronic and chronic toxicity test are carried out mainly
for human medicine, dentistry and veterinary medicine.
In Figure 8 it is difficult to show the numbers of animals used for testing, for example,
household products and additives for human consumption because they are much lower than
EN 38 EN
in the other categories e.g. for household products only 800 animals were used whereas for
products for human medicine, dentistry and veterinary medicine almost
400 000 animals were used.
Overall products intended for medicine, dentistry and veterinary medicine required the
highest proportion of animals for the different types of tests i.e. approximately 39%. In
comparison to 2008 the amount of animals used in 2011 has been reduced by more than 130
000.
The next highest proportion is for 'other' toxicological evaluations, above 34%, (22% in 2008)
this means an increase of use of 122 000 animals. The third type of test using the largest
number of animals is that used for potential and actual contaminants in the general
environment with 92 000 animals or 9%.
EN 39 EN
Table 8.1: Number of animals used in toxicological and other safety evaluations
Type of tests versus products
Data of 2011*
8.1 Products 8.2 Acute and sub-acute toxicity
testing methods (including limit test)
8.3 Skin
irritation
8.4 Skin
sensitisa
tion
8.5 Eye
irritation
8.6 Sub-
chronic
and
chronic
toxicity
8.7
Carcino-
genicity
8.8
Develop-
mental
toxicity
8.9
Muta-
genicity
8.10
Repro-
ductive
toxicity
8.11
Toxicity to
aquatic
vertebrates
not
included in
other
columns
8.12
Other
8.13 Total
8.2.1.
LD50,
LC50
8.2.2.
Other
lethal
methods
8.2.3. Non
lethal
clinical
signs
methods
8.a. Products/ substances or devices
for human medicine and dentistry and
for veterinary medicine 40400 13904 86828 1772 14410 336 49351 6087 15247 10796 35906 1671 122646 399354
8.b. Products/ substances used or
intended to be used mainly in
agriculture 6079 7825 7479 992 3047 801 8200 4884 8335 2255 12359 7089 11634 80979
8.c. Products/ substances used or
intended to be used mainly in industry 3635 1690 13974 1461 10200 613 2691 4 11493 6805 14682 2208 9564 79020
8.d. Products/ substances used or
intended to be used mainly in the
household 40 119 79 47 76 2 80 0 0 0 46 0 348 837
8.e. Products/ substances used or
intended to be used mainly as
cosmetics or toiletries 25 25 40 0 0 0 0 0 0 0 0 0 0 90
8.f. Products/ substances used or
intended to be used mainly as additives
in food for human consumption 25 131 57 0 24 0 1300 0 0 152 0 0 741 2430
8.g. Products/ substances used or
intended to be used mainly as additives
in food for animal consumption 53 928 0 0 0 0 100 0 0 54 0 0 3469 4604
8.h. Potential or actual contaminants in
the general environment which do not
appear in other columns 27673 9521 6620 2 0 0 10759 664 5264 28 4439 25529 1867 92366
8.i. Other toxicological or safety
evaluations 186849 42432 20879 575 4411 358 7643 237 1443 1198 4884 2909 71375 345193
8.j. TOTAL 264779 76575 135956 4849 32168 2110 80124 11876 41782 21288 72316 39406 221644 1004873
(*) France reporting for 2010
EN 40 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
Subchronic
and
chronic
toxicity
Carcinogenicity,
Mutagenicity
and Reprotox
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 141132 16518 49351 68036 1671 122646 399354
8.b. Products/ substances used or intended to
be used mainly in agriculture 21383 4840 8200 27833 7089 11634 80979
8.c. Products/ substances used or intended to
be used mainly in industry 19299 12274 2691 32984 2208 9564 79020
8.d. Products/ substances used or intended to
be used mainly in the household 238 125 80 46 0 348 837
8.e. Products/ substances used or intended to
be used mainly as cosmetics or toiletries 90 0 0 0 0 0 90
8.f. Products/ substances used or intended to be
used mainly as additives in food for human
consumption 213 24 1300 152 0 741 2430
8.g. Products/ substances used or intended to
be used mainly as additives in food for animal
consumption 981 0 100 54 0 3469 4604
8.h. Potential or actual contaminants in the
general environment which do not appear in
other columns 43814 2 10759 10395 25529 1867 92366
8.i. Other toxicological or safety evaluations
250160 5344 7643 7762 2909 71375 345193
8.j. TOTAL 477310 39127 80124 147262 39406 221644 1004873