Explanatory Memorandum to SEC(2010)1107 - Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the EU - Main contents
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| dossier | SEC(2010)1107 - Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Sixth Report on the ... |
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| source | SEC(2010)1107  |
| date | 30-09-2010 |
Contents
Brussels, 8.12.2010
SEC(2010) 1107 final/2
VOL A
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COMMISSION STAFF WORKING DOCUMENT
Accompanying document to the
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT
Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union
COM(2010) 511
TABLE OF CONTENTS
II. DATA SUBMITTED AND GENERAL ASSESSMENT 5
II.1. Data submitted by the Member States 5
II.2. General assessment 5
II.3. Structure of the Report 7
PART A: COMPILATION AND OVERVIEW OF THE DATA OF 2008 8
III.1. Results of EU Table 1: Species and number of animals 8
III.2. Results of EU Table 1: Origin of animals used 16
III.3. Results of EU Table 2: Purposes of the experiments 19
III.4. Results of EU Table 3: Toxicological and safety evaluation by type of product/endpoint 23
III.5. Results of EU Table 4: Animals used for studies of diseases 26
III.6. Results of EU Table 5: Animals used in production and quality control of products for human medicine and dentistry and for veterinary medicine 31
III.7. Results of EU harmonized Table 6: Origin of regulatory requirements for animals used in toxicological and other safety evaluations 34
III.8. Results of EU Table 7: Animals used in toxicity tests for toxicological and other safety evaluations 37
III.9. Results of EU Table 8: Type of toxicity tests carried out for toxicological and other safety evaluations of products 41
I. INTRODUCTION
The objective of this report is to present to the Council and the European Parliament, in accordance with Article 26 of Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes1, the statistical data on the number of animals used for experimental and other scientific purposes in the Member States of the EU.
The first two statistical reports drafted in accordance with the provisions of the above mentioned directive which were published in 19942 and 19993, covering data on experimental animals collected in 1991 and 1996 respectively in the Member States, allowed only a limited amount of statistical analysis due to the absence of a consistent system of reporting the data. In 1997 an agreement was reached between the Commission and the competent authorities of the Member States to submit data for future reports using a format of eight harmonized tables. The third and fourth statistical reports published in 20034 and 20055 covering data collected in 1999 and 2002 were based on these agreed harmonized tables. This allowed a much wider interpretation of the results on the use of experimental animals in the EU. In spite of the progress made in the content of these two statistical reports, it ought to be stressed that there were some inconsistencies in the data submitted by the Member States and also that in all cases except the report of 2003, one Member State collected data from another year. The Fifth Statistical Report, published in 20076, contained for the first time data collected in the 10 Member States which joined the EU in 2004. In the Sixth Statistical Report the complete set of standardized tables provided by all 27 Member States were successfully evaluated, although comparison of the results with previous reports was essentially qualitative owing to the addition of data from the new Member States.
This Report includes data submitted by Romania and Bulgaria, which joined the EU in 2007. It gives an overview of the number of animals used in the Member States for experimental purposes for the year 2008 with the exception of one Member State which provided data from 2007.
The Commission Staff Working Document accompanies the Report from the Commission to the Council and the European Parliament – Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union. The report summarizes the data and conclusions presented in this Staff Working Document.
II. DATA SUBMITTED AND GENERAL ASSESSMENT
II.1. Data submitted by the Member States
All 27 Member States submitted the data in the agreed EU format.
A quality control check on the set of data submitted for 2008 has been carried out and is essentially governed by four criteria based on certain relationships between the data in the different tables.
- The first of these relationships is the total number of animals used by species, column 1.2 of EU table 1, which is broken down into purposes of experiments in EU table 2. Thus, the totals of the Tables 1 and 2 should be identical.
- The second relationship concerns column 2.6 of EU table 2 animals used for toxicological and other safety evaluation which is broken down into types of products/endpoints in EU table 3; into Regulatory requirements in EU table 6; and into types of toxicological tests in EU table 7. Therefore, the total of column 2.6 must be equal to the totals of tables 3, 6, 7 and in addition table 8 type of tests versus products respectively.
- The third relationship is that the sum of column 2.4 and 2.5 of EU table 2 must be equal to the total of EU table 5.
- In the fourth relationship, the total of EU table 3 should be equal to the total of table 8.
The last criterion has shown obvious weaknesses when tested on the tables provided by the Member States and has lead to include an additional 5th quality check criterion.
- Fifth: each individual total in the total line of table 3 must be equal to each individual total in the total column of table 8 as the column headings are identical.
For this Sixth report all the above quality criteria have been fulfilled by the Member States. It is therefore considered that the data provided by the Member States affords a consistent base for a sound statistical analysis of all eight EU tables.
II.2. General assessment
Each Member State is requested, pursuant to Articles 13 of Directive 86/609/EEC, to submit to the Commission the statistical data on the animals used for experimental and other scientific purposes. The data for this report covers the year 2008 with the exception of France which provided data from 2007.
Council Resolution 86/C331/02 of the representatives of the Governments of the Member States of the European Communities, meeting within the Council of 24 November 1986 regarding the protection of animals used for experimental and other scientific purposes7 allows the use of animals in experiments for education and training, but where the purposes of such experiments are not covered by the Directive, Member States will according to the Resolution apply national provisions which are no less severe than those of the Directive. Therefore, a number of Member States have also included animals covered by the Resolution in the report.
The first part of this report aims at providing a comprehensive overview on the numbers of animals used for various experimental purposes in the Community in 2008. The purposes of the use of animals have been analysed, and some of these purposes have been broken down further into more precise parameters. It also considers different legislative requirements regarding the use of experimental animals and the type of testing carried out on different species.
As the two newest Member States, Bulgaria and Romania, have submitted data for the first time, it is in principle not possible to draw accurate quantitative conclusions on the evolution of the use of animals for experimental purposes in the EU by comparing data with those of the previous reports. However, as their total use amounts to less than 1% of the total number of animals used in 2008, some comparisons in trends have been attempted, and significant changes in use have been highlighted in the report.
The second part of this report provides the individual data from the Member States together with their respective comments and interpretations.
In the EU, the total number of animals used for experimental and other scientific purposes in 2008 in the Member States amounts to just over 12 million (with data from France from 2007).
As in previous reports rodents together with rabbits represent more than 80% of the total number of animals used in the EU. Mice are by far the most commonly used species accounting for 59% of the total use, followed by rats with 17%.
The second most used group of animals was, as in previous years, cold-blooded animals which represent almost 10%. The third largest group of animals used was birds with a little over 6% of the total use.
As stated in the previous two statistical reports no Great Apes were used in experiments in the EU in 2008.
II.3. Structure of the Report
The report is divided into two parts:
A A global compilation and overview for the European Union of the statistical data of the Member States for 2008.
A consolidated table has been computed on the basis of the data submitted by the Member States for each EU table and is presented at the end of each chapter. Each table is illustrated by a graphical presentation to give a more readable overview of the EU situation.
Similarly to results of the Report of 2005, for which France submitted statistical data for 2004, the data analysed for this Report includes statistical data from the year 2007 from France. Therefore, the totals used in this report are a mixture of years. Comparisons were nevertheless made on this basis since no other data were available.
The reader is invited to take note that the numbering of tables and graphical presentation in Part A of the report are linked to the numbers of the EU tables and not to the numbering of the chapters of the report.
B The data submitted by each Member State with a summary of the Member State’s comments.
PART A: COMPILATION AND OVERVIEW OF THE DATA OF 2008
III.1. Results of EU Table 1: Species and number of animals
Two types of information can be drawn from the data submitted by the Member States in EU Table 1. The first relates to the total number of animals subdivided into 25 species used by the Member States. The second type of information relates to the place of origin of the animals used for experimental or other scientific purposes.
III.1.1. The data on the total number of animals used in the MS
Table 1.1 of this report presents the consolidated data on the number of animals used for experimental purposes, by species, submitted by 27 Member States. Whereas in previous years Malta had not used animals for scientific purposes, in 2008 this country reported animal use for the first time.
The total number of animals used in 2008 in the 27 Member States amounts to 12.0 million animals. It is important to note that the number of animals used in the new Member States who joined the EU in 2008 (Bulgaria and Romania) represents not even 1,0% of the total number of animals used in the EU 27.
III.1.2. Treatment and interpretation of the data of Table 1.1
In order to present an overall evaluation and subsequently a graphical analysis, animal species were grouped. The result of this exercise is presented in Table 1.2 at the end of this chapter. This grouping in Table 1.2 allows an overview of the species used and is illustrated in Figure 1.1.
It should also be pointed out that re-used animals are not included in the figures so that animals are not counted twice.
Rodents together with rabbits represent more than 80% of the total number of animals used. Mice (59,3%) and rats (17,6%) are by far the most commonly used species.
The second most used group is represented by cold-blooded animals namely reptiles, amphibians and fish at 9,6%.
Birds is the next highest animal group used for experimental purposes at 6,3%.
The Artiodactyla and Perissodactyla group including horses, donkeys and crossbreeds (Perrissodactyla), pigs, goats, sheep and cattle (Artiodactyla) represents 1,4% of the total number of animals used in the Member States.
Carnivores represent 0,3% of the total number of animals used and non-human primates represent 0,08% of the animals used in 2008.
III.1.3. Comparison with the data of the previous reports
In this chapter, and the following chapters where comparisons are addressed, the reader is invited to take note of the fact that in 1996, in 2002, in 2005 and for this report France has reported data respectively for 1997, 2001, 2004 and 2007 which does not allow a rigorous comparison between data reported for each year. Nevertheless, assuming that fluctuations in the annual numbers of animals used per species in a country are limited, it is possible to make semi-quantitative estimates of the observed trends by comparing changes in proportions of use, expressed as a percentage.
Comparison between proportions of classes of animals used in 1996, 1999, 2002, 2005 and 2008
| Class of species | 1996(*) | 1999 | 2002(**) | 2005(***) | 2008(****) |
| % Rodents-rabbits | 81,3 | 86,9 | 78,0 | 77,5 | 82,2 |
| % Cold-blooded animals | 12,9 | 6,6 | 15,4 | 15, | 9,6 |
| % Birds | 4,7 | 5 | 5,4 | 6,4 | |
| % Artio and Perissodactyla | 1,2 | 1,2 | 1,1 | 1,4 |
(*) 14 Member States reporting for 1996, one for 1997
(**) 14 Member States reporting for 2002, one for 2001
(***) 24 Member States reporting for 2005, one for 2004
(****) 27 Member States reporting for 2008, one for 2007
Overall, the percentage of rodents and rabbits shows some fluctuation, but remains close to 80%. For cold-blooded animals the proportion used in 1996, in 2002 and 2005 is between 12 to 15%. In 2008 the use of cold-blooded animals has dropped considerably to below 10%. However, in 1999 a much lower percentage of 6,6% was observed.
Birds representing the third largest percentage of animals used, seems to be in constant increase over the years from 4 to 6,4%. The group of horses, donkeys and cross-bred animals (artiodactyla) and pigs, goats, sheep and cattle (perissodactyla) fluctuates at around 1%.
Contrary to what would have been expected, the effect of the inclusion of the data of new Member States since 2005 i.e. Bulgaria and Romania, did not lead to an increase in the total number of animals, on the contrary, there is a decrease of more than 116,500 animals.
Table 1.0 contains a comparison of the change that has taken place since 2008 for each species, expressed in number of animals per species, between EU 27 (data from 2008) and EU 25 (data from 2005) (first three columns) and in percentage per species (fourth column). The second half is a comparison between EU 25 (data of 2008 without Romania and Bulgaria)
Table 1.0 : Changes in species number and proportion between 2005 and 2008
| Species | Number of animals in EU 25 2005 | Number of animals in EU 27 2008 | Change since 2005 | % change by species | Change since 2005 | Number of animals EU 25 2008 excl. RO,BG | % change by species |
| 1.a Mice (Mus musculus) | 6430346 | 7122188 | 691842 | 10,76 | 630992 | 7061338 | 9,81 |
| 1.b Rats (Rattus norvegicus) | 2336032 | 2121727 | -214305 | -9,17 | -223989 | 2112043 | -9,59 |
| 1.c Guinea-Pigs (Cavia porcellus) | 257307 | 220985 | -36322 | -14,12 | -46774 | 210533 | -18,18 |
| 1.d Hamsters (Mesocricetus ) | 31535 | 32739 | 1204 | 3,82 | 759 | 32294 | 2,41 |
| 1.e Other Rodents (other Rodentia) | 64474 | 39506 | -24968 | -38,73 | -24968 | 39506 | -38,73 |
| 1.f Rabbits (Oryctolagus cuniculus) | 312681 | 333213 | 20532 | 6,57 | 17514 | 330195 | 5,60 |
| 1.g Cats (Felis catus) | 3898 | 4088 | 190 | 4,87 | 179 | 4077 | 4,59 |
| 1.h Dogs (Canis familiaris) | 24119 | 21315 | -2804 | -11,63 | -2819 | 21300 | -11,69 |
| 1.i Ferrets (Mustela putorius furo) | 2690 | 3208 | 518 | 19,26 | 518 | 3208 | 19,26 |
| 1.j Other Carnivores | 8711 | 2853 | -5858 | -67,25 | -5858 | 2853 | -67,25 |
| 1.k Horses, donkeys and cross breds (Equidae) | 5312 | 5976 | 664 | 12,50 | 633 | 5945 | 11,92 |
| 1.l Pigs (Sus) | 66305 | 92813 | 26508 | 39,98 | 26369 | 92674 | 39,77 |
| 1.m Goats (Capra) | 2146 | 3840 | 1694 | 78,94 | 1614 | 3760 | 75,21 |
| 1.n Sheep (Ovis) | 30021 | 30190 | 169 | 0,56 | -212 | 29809 | -0,71 |
| 1.o Cattle (Bos) | 36271 | 33952 | -2319 | -6,39 | -2448 | 33823 | -6,75 |
| 1.p Prosimians (Prosimia) | 677 | 1261 | 584 | 86,26 | 584 | 1261 | 86,26 |
| 1.q New World Monkeys (Ceboidea) | 1564 | 904 | -660 | -42,20 | -660 | 904 | -42,20 |
| -1.r Old World Monkeys (Cercopithecoidea) | 8208 | 7404 | -804 | -9,80 | -804 | 7404 | -9,80 |
| 1.s Apes (Hominoidea) | 0 | 0 | 0 | 0,00 | 0 | 0 | 0,00 |
| 1.t Other Mammals (other Mammalia) | 9950 | 5704 | -4246 | -42,67 | -4246 | 5704 | -42,67 |
| 1.u Quail (Coturnix coturnix) | 9246 | 9626 | 380 | 4,11 | 371 | 9617 | 4,01 |
| 1.v Other birds (other Aves) | 649813 | 754485 | 104672 | 16,11 | 101999 | 751812 | 15,70 |
| 1.w Reptiles (Reptilia) | 2477 | 4101 | 1624 | 65,56 | 1624 | 4101 | 65,56 |
| 1.x Amphibians (Amphibia) | 74620 | 61789 | -12831 | -17,20 | -17631 | 56989 | -23,63 |
| 1.y Fish (Pisces) | 1749178 | 1087155 | -662023 | -37,85 | -662073 | 1087105 | -37,85 |
| 1.z TOTAL | 12117581 | 12001022 | -116559 | -0,96 | -209326 | 11908255 | -1,73 |
There is an increase in the number of mice used since 2005 of 691,842 which is 10,7% of the total number of mice used in 2005 and a decrease for rats (9,2%) and fish (37,8%). The largest change in 2008, increase in the use of mice, is almost entirely compensated for by the decrease in the use of fish.
The total number of pigs, goats, prosimians, and reptiles has increased by between 40% – 86,3%.
The total number of rats, guinea-pigs, other rodents, dogs, cattle and other mammals as well as amphibians and fish used has decreased substantially since the last report. When expressed in percentages these decreases range from more than 40 to around 9%.
The largest percentile change has, however, been noted in the decrease of the use of other carnivores. However, these species are not used in great numbers (from 8,711 to 2,853). There is also a large decrease of 42,7% in the total number of other mammals.
It is also worth noting the large decrease in the use of new world monkeys of 42,2% as well as a decrease of 9,8% of old world monkeys. Prosimian use overall, however, has increased by 86,3%.
For species used in greater numbers, significant increases occurred in 2008 for mice, rabbits, pigs and other birds where percentage changes ranged from 6,6 to 40%.
The following animals which are normally used in fewer numbers show an increase in use: ferrets (19,3%), horses, donkeys and cross-breeds (12,5%), goats (78,9%) and reptiles (65,5%).
As in 2002 and 2005, no great apes were used for experimental or other scientific purposes in 2008.
Member States provided examples of the type of species covered by category other as follows:
Other rodents: gerbils, old world jerboas (Jaculus jaculus); chinchillas, beavers, ground squirrels, hamsters, grey dwarf hamsters (Cricetulus migratorius) and different species of mice.
Other carnivores: wild-life species used for zoological and ecological studies e.g. foxes, badgers, seals, otters and fitchew.
Other mammals: boars, bats and shrews, llamas, moles, European bison and red deer.
Other birds: mainly Japanese Quail (coturnix japonica) and bob-white quail, poultry species, and zebra finches, canaries, parakeets, parrots and farmed avian species for example, chickens.
In the three columns in the second half of the table, the addition of data from Bulgaria, Romania has virtually no effect on the proportional changes between the species.
Romania has little effect on the proportional changes between the species ranging from no change to very marginal variations per species. However, there is a net decrease of guinea pigs – 4%, and 10% for amphibians, when data from Bulgaria and Romania are excluded.
Table 1.1: Total number of animals used for experimental purposes in the EU Member States
Data of 2008 (*)
| Species | AT | BE | BG | CY | CZ | DK | ET | FI | FR | DE | EL | HU | IE | IT | LV | LT | LU | MT | NL | PL | PT | RO | SP | SK | SL | SE | UK | Totals |
| 1a. Mice | 177544 | 480681 | 16265 | 2114 | 54776 | 168164 | 28754 | 78446 | 1561809 | 1314493 | 19786 | 158799 | 71224 | 553000 | 6912 | 3827 | 3280 | 50 | 237681 | 123897 | 39811 | 44585 | 543680 | 6942 | 10313 | 203112 | 1212243 | 7122188 |
| 1b. Rats | 9928 | 108580 | 4513 | 0 | 21531 | 75850 | 5268 | 26058 | 392773 | 390853 | 4367 | 89375 | 11741 | 230347 | 2407 | 1194 | 430 | 44 | 105780 | 45824 | 6571 | 5171 | 175325 | 9692 | 1675 | 53141 | 343289 | 2121727 |
| 1c. Guinea-Pigs | 3284 | 36554 | 3845 | 0 | 1902 | 5343 | 22 | 215 | 46030 | 35870 | 45 | 9743 | 91 | 13875 | 32 | 93 | 100 | 0 | 6062 | 6495 | 152 | 6607 | 12620 | 982 | 7 | 1766 | 29250 | 220985 |
| 1d. Hamsters | 693 | 2124 | 182 | 0 | 251 | 4 | 120 | 302 | 12063 | 7061 | 0 | 215 | 68 | 717 | 0 | 0 | 0 | 0 | 3358 | 312 | 29 | 263 | 1262 | 0 | 0 | 864 | 2851 | 32739 |
| 1e.Other Rodents | 47 | 1055 | 1233 | 1760 | 0 | 3142 | 3594 | 8392 | 356 | 1235 | 0 | 2439 | 11966 | 251 | 45 | 0 | 2033 | 1958 | 39506 | |||||||||
| 1f. Rabbits | 18761 | 42025 | 813 | 0 | 6304 | 2931 | 630 | 814 | 96427 | 97938 | 1498 | 8134 | 204 | 9706 | 48 | 199 | 20 | 0 | 7418 | 3086 | 99 | 2205 | 19626 | 679 | 307 | 1332 | 12009 | 333213 |
| 1g. Cats | 2 | 78 | 11 | 0 | 45 | 154 | 0 | 1848 | 798 | 4 | 40 | 295 | 26 | 0 | 0 | 0 | 0 | 253 | 83 | 0 | 100 | 18 | 0 | 149 | 184 | 4088 | ||
| 1h. Dogs | 41 | 788 | 15 | 0 | 552 | 271 | 0 | 54 | 4131 | 4450 | 44 | 686 | 557 | 943 | 0 | 0 | 0 | 0 | 1244 | 230 | 0 | 1046 | 4 | 0 | 1982 | 4277 | 21315 | |
| 1i. Ferrets | 14 | 324 | 0 | 0 | 122 | 117 | 0 | 800 | 55 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 472 | 0 | 0 | 287 | 0 | 0 | 39 | 978 | 3208 | |||
| 1j.Other Carnivores | 0 | 0 | 45 | 101 | 0 | 761 | 0 | 410 | 0 | 0 | 0 | 10 | 520 | 5 | 0 | 53 | 948 | 2853 | ||||||||||
| .k. horses, donkeys & cross-breeds | 47 | 62 | 17 | 378 | 54 | 0 | 37 | 652 | 584 | 1 | 40 | 144 | 46 | 0 | 2562 | 529 | 6 | 14 | 90 | 0 | 423 | 290 | 5976 | |||||
| 1l. Pigs | 5086 | 2969 | 137 | 2013 | 6863 | 819 | 8768 | 12361 | 624 | 1193 | 224 | 3607 | 80 | 0 | 11729 | 11742 | 222 | 2 | 15121 | 22 | 3 | 1973 | 7255 | 92813 | ||||
| 1m. Goats | 39 | 195 | 80 | 174 | 107 | 0 | 1159 | 531 | 24 | 92 | 41 | 0 | 229 | 300 | 372 | 5 | 0 | 5 | 487 | 3840 | ||||||||
| 1n. Sheep | 142 | 356 | 250 | 1148 | 88 | 571 | 3573 | 4638 | 68 | 200 | 456 | 469 | 0 | 3486 | 2217 | 28 | 131 | 2386 | 9 | 4 | 152 | 9818 | 30190 | |||||
| 1o. Cattle | 574 | 657 | 126 | 799 | 939 | 0 | 300 | 3206 | 6252 | 72 | 93 | 4019 | 462 | 0 | 2236 | 7540 | 10 | 3 | 1091 | 0 | 1379 | 4194 | 33952 | |||||
| 1p. Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 718 | 543 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1261 | |||
| 1q.N W Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 233 | 305 | 0 | 5 | 18 | 0 | 0 | 0 | 0 | 73 | 0 | 0 | 8 | 0 | 0 | 0 | 262 | 904 | |||
| 1r.O W Monkeys | 0 | 41 | 0 | 0 | 80 | 0 | 0 | 1797 | 1415 | 0 | 1 | 344 | 0 | 0 | 0 | 0 | 82 | 0 | 0 | 517 | 0 | 0 | 35 | 3092 | 7404 | |||
| 1s. Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
| ..t.Other Mammals | 0 | 151 | 1774 | 243 | 84 | 0 | 541 | 16 | 32 | 151 | 0 | 202 | 1246 | 28 | 21 | 0 | 263 | 952 | 5704 | |||||||||
| 1u. Quail | 14 | 431 | 0 | 0 | 0 | 0 | 0 | 1548 | 1803 | 0 | 13 | 249 | 0 | 0 | 0 | 0 | 0 | 5100 | 9 | 138 | 120 | 0 | 201 | 0 | 9626 | |||
| 1v. Other birds | 1367 | 17151 | 1477 | 148722 | 2820 | 5568 | 156814 | 53986 | 88 | 32554 | 582 | 32241 | 40 | 0 | 90890 | 27391 | 160 | 1196 | 52104 | 696 | 129 | 3432 | 125077 | 754485 | ||||
| 1w. Reptiles | 17 | 374 | 1012 | 221 | 317 | 758 | 192 | 108 | 454 | 0 | 121 | 248 | 0 | 170 | 109 | 4101 | ||||||||||||
| 1x. Amphibians | 277 | 2388 | 4800 | 3016 | 293 | 34 | 9451 | 10815 | 200 | 1182 | 2432 | 149 | 0 | 870 | 1221 | 704 | 0 | 641 | 23316 | 61789 | ||||||||
| 1y. Fish | 2579 | 28386 | 50 | 54836 | 31245 | 21078 | 20228 | 67496 | 1200 | 2077 | 23198 | 13955 | 0 | 600 | 23859 | 25941 | 3800 | 71098 | 25 | 0 | 211459 | 484045 | 1087155 | |||||
| 1z.TOTAL | 220456 | 725370 | 32581 | 2114 | 300713 | 297568 | 34794 | 138600 | 2328380 | 2021782 | 28021 | 304922 | 112835 | 864318 | 9399 | 5582 | 3830 | 694 | 501056 | 275888 | 50888 | 60186 | 897859 | 19260 | 12438 | 484604 | 2266884 | 12001022 |
(*) France is reporting for 2007
Table 1.2: Classes of animals used for experimental purposes in the EU Member States
Data of 2008 (*)
| Species | AT | BE | BG | CY | CZ | DK | ET | FI | FR | DE | EL | HU | IE | IT | LV | LT | LU | MT | NL | PL | PT | RO | SP | SK | SL | SE | UK | Totals |
| Mice | 177544 | 480681 | 16265 | 2114 | 54776 | 168164 | 28754 | 78446 | 1561809 | 1314493 | 19786 | 158799 | 71224 | 553000 | 6912 | 3827 | 3280 | 50 | 237681 | 123897 | 39811 | 44585 | 543680 | 6942 | 10313 | 203112 | 1212243 | 7122188 |
| Rats | 9928 | 108580 | 4513 | 0 | 21531 | 75850 | 5268 | 26058 | 392773 | 390853 | 4367 | 89375 | 11741 | 230347 | 2407 | 1194 | 430 | 44 | 105780 | 45824 | 6571 | 5171 | 175325 | 9692 | 1675 | 53141 | 343289 | 2121727 |
| Guinea-Pigs | 3284 | 36554 | 3845 | 0 | 1902 | 5343 | 22 | 215 | 46030 | 35870 | 45 | 9743 | 91 | 13875 | 32 | 93 | 100 | 0 | 6062 | 6495 | 152 | 6607 | 12620 | 982 | 7 | 1766 | 29250 | 220985 |
| Hamsters + other rodents | 740 | 3179 | 182 | 0 | 1484 | 1764 | 120 | 3444 | 15657 | 15453 | 0 | 571 | 68 | 1952 | 0 | 0 | 0 | 0 | 5797 | 12278 | 29 | 263 | 1513 | 45 | 0 | 2897 | 4809 | 72245 |
| Rabbits | 18761 | 42025 | 813 | 0 | 6304 | 2931 | 630 | 814 | 96427 | 97938 | 1498 | 8134 | 204 | 9706 | 48 | 199 | 20 | 0 | 7418 | 3086 | 99 | 2205 | 19626 | 679 | 307 | 1332 | 12009 | 333213 |
| Cold-blooded animals (1) | 2873 | 31148 | 4850 | 0 | 58864 | 31759 | 0 | 21429 | 30437 | 78503 | 1400 | 3367 | 23198 | 16841 | 0 | 149 | 0 | 600 | 24850 | 27410 | 3800 | 0 | 71802 | 25 | 0 | 212270 | 507470 | 1153045 |
| Birds (2) | 1381 | 17582 | 1477 | 0 | 148722 | 2820 | 0 | 5568 | 158362 | 55789 | 88 | 32567 | 582 | 32490 | 0 | 40 | 0 | 0 | 90890 | 32491 | 160 | 1205 | 52242 | 816 | 129 | 3633 | 125077 | 764111 |
| Artio+perissodactyla (3) | 5888 | 4239 | 610 | 0 | 4512 | 8051 | 0 | 1727 | 17358 | 24366 | 789 | 1618 | 4843 | 4625 | 0 | 80 | 0 | 0 | 20242 | 22328 | 266 | 150 | 19060 | 36 | 7 | 3932 | 22044 | 166771 |
| Carnivores | 57 | 1190 | 26 | 0 | 764 | 643 | 0 | 815 | 6779 | 5713 | 48 | 726 | 852 | 969 | 0 | 0 | 0 | 0 | 1979 | 833 | 0 | 0 | 1438 | 22 | 0 | 2223 | 6387 | 31464 |
| Prosimians+monkeys +apes | 0 | 41 | 0 | 0 | 80 | 0 | 0 | 0 | 2748 | 2263 | 0 | 6 | 0 | 362 | 0 | 0 | 0 | 0 | 155 | 0 | 0 | 0 | 525 | 0 | 0 | 35 | 3354 | 9569 |
| Other mammals | 0 | 151 | 1774 | 243 | 84 | 0 | 541 | 16 | 32 | 151 | 0 | 202 | 1246 | 28 | 21 | 0 | 263 | 952 | 5704 | |||||||||
| TOTAL | 220456 | 725370 | 32581 | 2114 | 300713 | 297568 | 34794 | 138600 | 2328380 | 2021782 | 28021 | 304922 | 112835 | 864318 | 9399 | 5582 | 3830 | 694 | 501056 | 275888 | 50888 | 60186 | 897859 | 19260 | 12438 | 484604 | 2266884 | 12001022 |
| Species % | AT | BE | BG | CY | CZ | DK | ET | FI | FR | DE | EL | HU | IE | IT | LV | LT | LU | MT | NL | PL | PT | RO | SP | SK | SL | SE | UK | Totals |
| Mice | 80,53 | 66,27 | 49,92 | 100,00 | 18,22 | 56,51 | 82,64 | 56,60 | 67,08 | 65,02 | 70,61 | 52,08 | 63,12 | 63,98 | 73,54 | 68,56 | 85,64 | 7,20 | 47,44 | 44,91 | 78,23 | 74,08 | 60,55 | 36,04 | 82,92 | 41,91 | 53,48 | 59,35 |
| Rats | 4,50 | 14,97 | 13,85 | 0,00 | 7,16 | 25,49 | 15,14 | 18,80 | 16,87 | 19,33 | 15,58 | 29,31 | 10,41 | 26,65 | 25,61 | 21,39 | 11,23 | 6,34 | 21,11 | 16,61 | 12,91 | 8,59 | 19,53 | 50,32 | 13,47 | 10,97 | 15,14 | 17,68 |
| Guinea-Pigs | 1,49 | 5,04 | 11,80 | 0,00 | 0,63 | 1,80 | 0,06 | 0,16 | 1,98 | 1,77 | 0,16 | 3,20 | 0,08 | 1,61 | 0,34 | 1,67 | 2,61 | 0,00 | 1,21 | 2,35 | 0,30 | 10,98 | 1,41 | 5,10 | 0,06 | 0,36 | 1,29 | 1,84 |
| Hamsters + other rodents | 0,34 | 0,44 | 0,56 | 0,00 | 0,49 | 0,59 | 0,34 | 2,48 | 0,67 | 0,76 | 0,00 | 0,19 | 0,06 | 0,23 | 0,00 | 0,00 | 0,00 | 0,00 | 1,16 | 4,45 | 0,06 | 0,44 | 0,17 | 0,23 | 0,00 | 0,60 | 0,21 | 0,60 |
| Rabbits | 8,51 | 5,79 | 2,50 | 0,00 | 2,10 | 0,98 | 1,81 | 0,59 | 4,14 | 4,84 | 5,35 | 2,67 | 0,18 | 1,12 | 0,51 | 3,57 | 0,52 | 0,00 | 1,48 | 1,12 | 0,19 | 3,66 | 2,19 | 3,53 | 2,47 | 0,27 | 0,53 | 2,78 |
| Cold-blooded animals (1) | 1,30 | 4,29 | 14,89 | 0,00 | 19,57 | 10,67 | 0,00 | 15,46 | 1,31 | 3,88 | 5,00 | 1,10 | 20,56 | 1,95 | 0,00 | 2,67 | 0,00 | 86,46 | 4,96 | 9,94 | 7,47 | 0,00 | 8,00 | 0,13 | 0,00 | 43,80 | 22,39 | 9,61 |
| Birds (2) | 0,63 | 2,42 | 4,53 | 0,00 | 49,46 | 0,95 | 0,00 | 4,02 | 6,80 | 2,76 | 0,31 | 10,68 | 0,52 | 3,76 | 0,00 | 0,72 | 0,00 | 0,00 | 18,14 | 11,78 | 0,31 | 2,00 | 5,82 | 4,24 | 1,04 | 0,75 | 5,52 | 6,37 |
| Artio+perissodactyla (3) | 2,67 | 0,58 | 1,87 | 0,00 | 1,50 | 2,71 | 0,00 | 1,25 | 0,75 | 1,21 | 2,82 | 0,53 | 4,29 | 0,54 | 0,00 | 1,43 | 0,00 | 0,00 | 4,04 | 8,09 | 0,52 | 0,25 | 2,12 | 0,19 | 0,06 | 0,81 | 0,97 | 1,39 |
| Carnivores | 0,03 | 0,16 | 0,08 | 0,00 | 0,25 | 0,22 | 0,00 | 0,59 | 0,29 | 0,28 | 0,17 | 0,24 | 0,76 | 0,11 | 0,00 | 0,00 | 0,00 | 0,00 | 0,39 | 0,30 | 0,00 | 0,00 | 0,16 | 0,11 | 0,00 | 0,46 | 0,28 | 0,26 |
| Prosimians+monkeys+ apes | 0,00 | 0,01 | 0,00 | 0,00 | 0,03 | 0,00 | 0,00 | 0,00 | 0,12 | 0,11 | 0,00 | 0,00 | 0,00 | 0,04 | 0,00 | 0,00 | 0,00 | 0,00 | 0,03 | 0,00 | 0,00 | 0,00 | 0,06 | 0,00 | 0,00 | 0,01 | 0,15 | 0,08 |
| Other mammals | 0,00 | 0,02 | 0,00 | 0,00 | 0,59 | 0,08 | 0,00 | 0,06 | 0,00 | 0,03 | 0,00 | 0,01 | 0,03 | 0,02 | 0,00 | 0,00 | 0,00 | 0,00 | 0,04 | 0,45 | 0,00 | 0,00 | 0,00 | 0,11 | 0,00 | 0,05 | 0,04 | 0,05 |
| Mice | ||||||||||||||||||||||||||||
| TOTAL | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
| FR(*) France reporting for 2007 | ||||||||||||||||||||||||||||
| (1) reptiles + amphibians + fish | ||||||||||||||||||||||||||||
| (2) Quails and other birds | ||||||||||||||||||||||||||||
| (3) Horses, donkeys, and cross breeds + pigs + goats and sheep +cattle | ||||||||||||||||||||||||||||
| (4) Cats + dogs + ferrets + other carnivores |
III.2. Results of EU Table 1: Origin of animals used
III.2.1. The data on the origin of the species
The consolidated results of EU Table 1 on the origin of some selected species used for experimental purposes in the 27 Member States are reported in Table 1.3 at the end of this chapter. The consolidated table 1.3 only indicates species for which the origin must be reported.
In addition, EU Table 1.3 contains information on the number of animals re-used in experiments.
III.2.2. Treatment and interpretation of the data
The data of column 1.3 and 1.4 of Table 1.3 of this report have been grouped to represent animals coming from the European Union.
Figure 1.2 represents the percentage of animals from the reported origin versus the species.
The chart shows clearly that the majority of the species originated from EU countries. However, certain species such as cats, dogs and ferrets and old world monkeys are also of non-European origin.
III.2.3. Comparison with data of the previous report
The general pattern on the origin of the species is quite similar to that observed in previous reports. It should be noted however, that for the first time in 2005 the prosimians were all of EU origin and remain so for this report. A similar trend can also be observed with the new world monkeys where almost all originate from either EU Member States or countries which are a party to the Council of Europe Convention ETS 123. Finally, also old world monkeys coming from the EU increased from about 26% in 2005 to more than 50% in 2008. On the other hand the number of cats of EU origin also increased whereas dogs and ferrets of non-European origin have remained unchanged since the last report.
Table 1.3: Number of animals used in relation to their place of origin
Data of 2008 (*)
| 1.1Species | 1.2. Total | 1.3. Animals coming from registered breeding or supplying establishments within the reporting country | 1.4. Animals coming from elsewhere in the EC | 1.5. Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) | 1.6. Animals coming from other origins | 1.7. Re-used animals |
| 1.a. Mice (Mus musculus) | 7122188 | 6042205 | 900230 | 21382 | 158371 | 3768 |
| 1.b. Rats (Rattus norvegicus) | 2121727 | 1761785 | 329385 | 9844 | 20713 | 3035 |
| 1.c. Guinea-Pigs (Cavia porcellus) | 220985 | 161973 | 56167 | 2051 | 792 | 962 |
| 1.d. Hamsters (Mesocricetus ) | 32739 | 24999 | 5476 | 1074 | 1190 | 54 |
| 1.f. Rabbits (Oryctolagus cuniculus) | 333213 | 315006 | 14753 | 364 | 3087 | 15958 |
| 1.g. Cats (Felis catus) | 4088 | 2306 | 726 | 14 | 1042 | 1181 |
| 1.h. Dogs (Canis familiaris) | 21315 | 12467 | 2885 | 309 | 5654 | 4178 |
| 1.i. Ferrets (Mustela putorius furo) | 3208 | 1847 | 442 | 0 | 919 | 64 |
| 1.p. Prosimians (Prosimia) | 1261 | 718 | 543 | 0 | 0 | 33 |
| 1.q. New World Monkeys (Ceboidea) | 904 | 816 | 83 | 5 | 0 | 346 |
| 1.r. Old World Monkeys (Cercopithecoidea) | 7404 | 3213 | 850 | 5 | 3336 | 1509 |
| 1.s. Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.u. Quail (Coturnix coturnix) | 9626 | 7824 | 1500 | 0 | 302 | 0 |
| 1.z. TOTAL | 9878658 | 8335159 | 1313040 | 35048 | 195406 | |
| * France: data of 2007 | ||||||
| Note 1: Column 1.5 concerns only those 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. |
III.3. Results of EU Table 2: Purposes of the experiments
III.3.1. The data on purposes of the experiments
The consolidated data on purposes of the experiments of the 27 Member States are presented in Table 2.1 at the end of this chapter.
III.3.2. Treatment and interpretation of the data
Table 2.2 presents the results of the consolidated data of the purposes of the procedures carried out in the 27 Member States in 2008. In order to facilitate the presentation of results some species and some purposes were grouped in Table 2.2.
The percentage of the number of animals used for selected purposes is presented in Figure 2.1.
More than 60% of animals were used in research and development for human medicine, veterinary medicine, dentistry and in fundamental biological studies.
Production and quality control of products and devices in human medicine, veterinary medicine and dentistry required the use of 14,9% of the total number of animals.
Toxicological and other safety evaluation represents 8,7% of the total number of animals used for experimental purposes.
Other purposes of procedures represents 12% of the total number of animals and covers a wide range of experiments such as virology, immunology for production of monoclonal and polyclonal antibodies, physiology of foetal-maternal interaction in mouse gene transgensis, oncological treatment, pharmaceutical research and development, combined drug testing and genetics.
III.3.3. Comparison with the data of the previous report
The comparison aims to detect changes in trends rather than draw formal conclusions. The most significant change that has taken place since 2005 is that the number of animals used for research and development for human medicine, dentistry and veterinary medicine has dropped sharply from 31% to 22,8% (in terms of animal numbers the decrease is from 3,746,028 to 2,733,706). To be noted in particular is the significant reduction of more than 800,000 cold-blooded animals since the last report of 2005. On the other hand, the percentage of animals used for fundamental biological research has increased from 33% to 38% (that is, from 4,035,470 to 4,575,054) as well as for other purposes, from 8% to 12%. It should be underlined that both fundamental biology and research and development in human and veterinary medicine are the areas using by far the highest number of animals for experimental purposes in the EU.
The number of animals used for toxicological and other safety evaluation has remained virtually unchanged since the last report and amounts to 8,7% of the total number of animals used for experimental purposes in the EU. This represents 1,042,153 animals.
In general the number of animals used for production and quality control of devices for medicine, veterinary medicine and dentistry has also remained unchanged since 2005. However, regarding the use by species, the use of mice and rabbits has increased substantially for production and quality control of products and devices for human medicine and dentistry. One Member State indicated that funding had been made available for pre-clinical trials for human medicine, which lead to an increase in use of experimental animals.
Another Member State using a large number of rabbits for production and quality control of veterinary medicine indicated that the laboratory responsible for that increase had reported the data in the wrong column, that is, they should have been reported under production and quality control of human medicine and dentistry rather than for products and devices for veterinary medicine. The increase was due to the production of polyclonal antibodies to improve transplant in human medicine. However, it was no longer possible to correct the error in the consolidated report.
Regarding increases in other purposes of use, there is a substantial increase in the use of mice, pigs and birds for fundamental biological research and in other experiments.
Several Member States confirmed that the increase in the use of mice for fundamental biological research is attributed to the new research possibilities offered by the transgenic species. These animal models are being used both for human and animal health studies. An increase was also reported for the purpose of experiments in anatomy and developmental biology, physiology, genetics and cancer research, and for immunology and microbiology.
There are several reasons for the increase in the use of pigs in ‘fundamental biological’ and also in ‘other studies’. One Member State using a large number of pigs for fundamental biological studies and for other procedures indicated that in recent years funding for projects relating to cardiovascular research has increased significantly. The same applies in the case of experimental surgery which is taking place in many hospitals in the same Member State. Another area using an increased number of pigs relates to pig disease studies, including for example the observation of vaccine effectiveness. It was reported that the increase was also due to fundamental research on pigs’ enzymes and digestive functions, and because the tissues and organs of transgenic pigs are used for transplants in humans.
The large number of birds used for fundamental biological research in one Member State was due to a campaign of bird ringing. The increase of the number of birds used for other experiments was reported to be due to parasitology/immunology studies and to the development of genetically modified birds.
Table 2.2: Number of animals used for selected purposes versus species
| Species | Biological studies of a 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 | 3080775 | 2624856 | 398199 | 137578 | 82606 | 798174 | 7122188 |
| Rats | 595542 | 1060290 | 294683 | 22997 | 59412 | 88803 | 2121727 |
| Other rodents | 44240 | 195427 | 33858 | 3145 | 7826 | 8734 | 293230 |
| Rabbits | 17813 | 212618 | 39987 | 3376 | 3326 | 56093 | 333213 |
| Carnivores | 4804 | 11378 | 11964 | 1360 | 515 | 1443 | 31464 |
| Artio+perissodactyla | 55080 | 56359 | 8996 | 4620 | 13134 | 28582 | 166771 |
| Prosimians+monkeys+apes | 1213 | 1260 | 6507 | 153 | 10 | 426 | 9569 |
| Other mammals | 5279 | 177 | 0 | 12 | 25 | 211 | 5704 |
| Birds | 292895 | 247618 | 53477 | 8415 | 11444 | 150262 | 764111 |
| Cold-blooded animals | 477413 | 113766 | 194482 | 3651 | 29159 | 334574 | 1153045 |
| TOTAL | 4575054 | 4523749 | 1042153 | 185307 | 207457 | 1467302 | 12001022 |
Figure 2.2 presents the number of animals used for selected purposes by classes of species.
The highest number of mice and rats is attributed to fundamental biological studies and research, development and quality control of products and devices for medicine, dentistry and veterinary medicine. It is noteworthy that a high number of cold-blooded animals have been used for other purposes as well as for biological studies of a fundamental nature.
One can observe a significant reduction in the use of cold-blooded animals for research and development of devices for human and veterinary medicine and for dentistry since the last report of 2005.
Table 2.1: Number of animals used in experiments for selected purposes
Purposes versus species
data of 2008*
| 2.1.Species | 2.2.Biological studies of a fundamental nature | 2.3. Research and development of products and devices for human medicine and dentistry and for veterinary medicine(excluding toxicological and other safety evaluations counted in column 2.6) | 2.4. Production and quality control of products and devices for human medicine and dentistry | 2.5. Production and quality control of products and devices for veterinary medicine | 2.6. Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine | 2.7. Diagnosis of disease | 2.8. Education and training | 2.9. Other | 2.10. Total |
| 1.a. Mice (Mus musculus) | 3080775 | 1597381 | 856048 | 171427 | 398199 | 137578 | 82606 | 798174 | 7122188 |
| 1.b. Rats (Rattus norvegicus) | 595542 | 840909 | 181140 | 38241 | 294683 | 22997 | 59412 | 88803 | 2121727 |
| 1.c. Guinea-Pigs (Cavia porcellus) | 10632 | 44344 | 103852 | 17265 | 31883 | 1940 | 5804 | 5265 | 220985 |
| 1.d. Hamsters (Mesocricetus ) | 6994 | 8041 | 376 | 12513 | 1580 | 278 | 520 | 2437 | 32739 |
| 1.e. Other Rodents (other Rodentia) | 26614 | 9006 | 30 | 0 | 395 | 927 | 1502 | 1032 | 39506 |
| 1.f. Rabbits (Oryctolagus cuniculus) | 17813 | 29764 | 131031 | 51823 | 39987 | 3376 | 3326 | 56093 | 333213 |
| 1.g. Cats (Felis catus) | 560 | 1738 | 57 | 679 | 322 | 124 | 97 | 514 | 4091 |
| 1.h. Dogs (Canis familiaris) | 1814 | 4405 | 157 | 2070 | 11077 | 1111 | 362 | 316 | 21312 |
| 1.i. Ferrets (Mustela putorius furo) | 551 | 1287 | 564 | 8 | 269 | 45 | 56 | 428 | 3208 |
| 1.j. Other Carnivores (other Carnivora) | 1879 | 75 | 0 | 338 | 296 | 80 | 0 | 185 | 2853 |
| 1.k. Horses, donkeys and cross breds (Equidae) | 1402 | 728 | 224 | 2559 | 22 | 239 | 489 | 313 | 5976 |
| 1.l. Pigs (Sus) | 23531 | 22799 | 423 | 9001 | 8065 | 1452 | 8134 | 19408 | 92813 |
| 1.m. Goats (Capra) | 1098 | 721 | 93 | 26 | 43 | 90 | 422 | 1347 | 3840 |
| 1.n. Sheep (Ovis) | 9727 | 4098 | 6020 | 2149 | 409 | 1616 | 1243 | 4928 | 30190 |
| 1.o. Cattle (Bos) | 19322 | 3990 | 214 | 3314 | 457 | 1223 | 2846 | 2586 | 33952 |
| 1.p. Prosimians (Prosimia) | 568 | 0 | 0 | 0 | 543 | 150 | 0 | 0 | 1261 |
| 1.q. New World Monkeys (Ceboidea) | 235 | 235 | 33 | 0 | 270 | 0 | 0 | 131 | 904 |
| 1.r. Old World Monkeys (Cercopithecoidea) | 410 | 761 | 231 | 0 | 5694 | 3 | 10 | 295 | 7404 |
| 1.s. Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t. Other Mammals (other Mammalia) | 5279 | 86 | 28 | 63 | 0 | 12 | 25 | 211 | 5704 |
| 1.u. Quail (Coturnix coturnix) | 5520 | 57 | 0 | 0 | 2170 | 9 | 1575 | 295 | 9626 |
| 1.v. Other birds (other Aves) | 287375 | 77748 | 10593 | 159220 | 51307 | 8406 | 9869 | 149967 | 754485 |
| 1.w. Reptiles (Reptilia) | 3781 | 94 | 0 | 0 | 0 | 0 | 147 | 79 | 4101 |
| 1.x. Amphibians (Amphibia) | 32780 | 1914 | 0 | 0 | 291 | 202 | 12213 | 14389 | 61789 |
| 1.y. Fish (Pisces) | 440852 | 83525 | 20418 | 7815 | 194191 | 3449 | 16799 | 320106 | 1087155 |
| 1.z. TOTAL | 4575054 | 2733706 | 1311532 | 478511 | 1042153 | 185307 | 207457 | 1467302 | 12001022 |
(*) France is reporting for 2007
III.4. Results of EU Table 3: Toxicological and safety evaluation by type of product/endpoint
III.4.1. The data on toxicological and safety evaluation by type of product/endpoint
The consolidated table giving the number of animals used for toxicological and other safety evaluation of products (EU Table 3) in 27 Member States in 2008 is presented in Table 3.1 at the end of this chapter. In table 3.1 the number of animals used for toxicological or other safety evaluation is broken down into types of products for which testing was required.
The percentage of the number of animals used for different types of product is presented in Figure 3.
III.4.2. Treatment and interpretation of the data
The number of animals used for toxicological and other safety evaluation for different products or environmental test schemes amounts to 1,042,153, which represents 8,7% of the total number of animals used for experimental purposes in 2008 (see Table 2.1, column 2.6).
Toxicological or other safety evaluations are split up according to the type of sector for which they are intended. The percentage of animals used for toxicological evaluation of three groups of products/substances, i.e. additives in food for human consumption, cosmetics and household products, is very small (1,18%) when compared to the other product groups.
Products or devices used for human medicine, veterinary medicine and dentistry represents 50,8% of the animals used for toxicological or other safety evaluations.
The group of products/substances falling under the scrutiny of Member States authorities concerned with safety of health and of the environment by chemical products, such as industrial chemicals and pesticides, used 15% of the animals for toxicological and other safety evaluations.
There is a clear decrease in the number of animals used for toxicological tests for products intended for industry, for agriculture and for potential contaminants of the environment. The decrease ranges respectively from above 96,000 to about 82,000; from below 98,000 to about 74,000 and from above 84,000 to about 65,000 in comparison to the data submitted in the 2005 statistical report.
There is also a significant decrease in the number of animals used for testing of products for cosmetics and toiletries ranging from 5,500 to just below 2,000 (a 65% drop). This change has to be seen in light of the legal requirement to phase out animal testing for cosmetics in the EU where a ban on testing has been applicable since 2009 for all human health effects with the exception of three toxicological end-points: repeated-dose toxicity, reproductive toxicity and toxicokinetics. The year 2013 is the deadline for a marketing ban for cosmetics tested for these remaining specific health effects.
There is however also a significant increase since 2005 in the number of animals used for tests for additives in food for animal consumption (from 34,225 to 54,164). This may reflect the animal feed sanitary concerns expressed in the EU after the discovery of harmful contaminants in such products over the last 10 years.
It should also be noted that in comparison to the 2005 report, there is a significant increase in the number of animals used for ‘other’ toxicological or safety evaluation (ranging from around 180,000 to about 220,000). Member States reported that this particular use of animals concerned new methods and tests, such as tests on transmission of microcystins on embryonic membrane, bioassays, toxicity evaluation for humans via the environment, and control of safety of toys.
Table 3.1: Number of animals used in toxicological and other safety evaluation
Products versus species
Data of 2008*
| 3.1.Species | 3.2. Products/ substances or devices for human medicine and dentistry and for veterinary medicine | 3.3. Products/ 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) | 188227 | 10129 | 20249 | 1922 | 880 | 2818 | 1680 | 9433 | 162919 | 398257 |
| 1.b. Rats (Rattus norvegicus) | 187283 | 31421 | 41562 | 1709 | 174 | 2764 | 303 | 2932 | 26496 | 294644 |
| 1.c. Guinea-Pigs (Cavia porcellus) | 23152 | 2830 | 3679 | 0 | 38 | 24 | 7 | 0 | 2192 | 31922 |
| 1.d. Hamsters (Mesocricetus ) | 1559 | 0 | 21 | 0 | 0 | 0 | 0 | 0 | 0 | 1580 |
| 1.e. Other Rodents (other Rodentia) | 0 | 164 | 0 | 0 | 0 | 0 | 0 | 204 | 27 | 395 |
| 1.f. Rabbits (Oryctolagus cuniculus) | 30516 | 2696 | 4453 | 50 | 153 | 11 | 7 | 12 | 2127 | 40025 |
| 1.g. Cats (Felis catus) | 312 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 322 |
| 1.h. Dogs (Canis familiaris) | 9888 | 340 | 16 | 0 | 0 | 0 | 0 | 0 | 833 | 11077 |
| 1.i. Ferrets (Mustela putorius furo) | 269 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 269 |
| 1.j. Other Carnivores (other Carnivore) | 296 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 296 |
| 1.k. Horses, donkeys and cross breds (Equidae) | 22 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 22 |
| 1.l. Pigs (Sus) | 3169 | 90 | 0 | 0 | 0 | 100 | 4584 | 64 | 66 | 8073 |
| 1.m. Goats (Capra) | 21 | 14 | 0 | 0 | 0 | 0 | 0 | 8 | 0 | 43 |
| 1.n. Sheep (Ovis) | 408 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 409 |
| 1.o. Cattle (Bos) | 409 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 44 | 457 |
| 1.p. Prosimians (Prosimia) | 543 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 543 |
| 1.q. New World Monkeys (Ceboidea) | 200 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 70 | 270 |
| 1.r. Old World Monkeys (Cercopithecoidea) | 5121 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 573 | 5694 |
| 1.s. Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t. Other Mammals (other Mammalia) | 0 | 210 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 210 |
| 1.u. Quail (Coturnix coturnix) | 64 | 2110 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2174 |
| 1.v. Other birds (other Aves) | 8838 | 2116 | 30 | 0 | 0 | 0 | 39553 | 97 | 320 | 50954 |
| 1.w. Reptiles (Reptilia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.x. Amphibians (Amphibia) | 179 | 108 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 291 |
| 1.y. Fish (Pisces) | 69021 | 21915 | 12416 | 601 | 722 | 523 | 8030 | 53062 | 27936 | 194226 |
| 1.z. TOTAL | 529497 | 74147 | 82426 | 4282 | 1967 | 6240 | 54164 | 65812 | 223618 | 1042153 |
(*) France reporting for 2007
III.5. Results of EU Table 4: Animals used for studies of diseases
III.5.1. The data on animals used for studies of diseases
The consolidated table of results on animals used for studies of diseases (EU Table 4) in the 27 Member States is presented in Table 4.1 at the end of this chapter.
III.5.2. Treatment and interpretation of the data
Table 4.1 gives the number of animals used per type of studies on diseases.
In 2008 the number of animals used for the study of both animal and human diseases represented about 6,322,000 animals which is more than half (52%) the total number of animals used for experimental purposes in the EU.
Figure 4.1 presents the percentage of animals used in studies per type of diseases.
The proportion of animals used for studies of human diseases represents more than 90% of the total number of animals used for all disease studies.
Overall in 2008 there is a 50% decrease in the number of animals used for studies on specific animal diseases - from 1,329,000 to 614,000. In particular, a significant change occurred in the use of cold-blooded species where figures decreased from around 954,000 animals in 2005 to 43,914 in 2008.
Interesting to note is that despite the overall decrease, the use of mice increased substantially in 2008. Around 30% of the increase (about 681,000) can be attributed to different studies of diseases (see also observations under chapter III.3.3).
Some Member States confirmed that the increase of the use of animals in general, or mice in particular in table 4, is also reported under several headings of table 2, such as fundamental biological research and research and development of products for human and veterinary medicine and even production and control process for human and veterinary medicine. For the 2008 data one Member States indicated, however, that the increase of use of mice was primarily attributed to fundamental biological research.
It should be remembered that the studies on specific animal diseases are important in light of epidemic diseases affecting animals such as in the case of foot and mouth disease, swine fever and more recently avian flew. However, animals have also been used in studies on genetic diseases. According to 2008 data there has been more than a 50% reduction in animals used for studies on animal diseases. This could be because there have been no new significant animal disease epidemics in 2008 or in the preceding years.
The above observation is not necessarily reflected in the use of all species in particular for the use of mice and other birds by some Member States.
Regarding the specific animal diseases studies linked to the increase in the number of birds, Member States reported studies on bird flu, Gumboro disease and bronchitis including studies on quality and safety of vaccines.
Table 4.1: Number of animals used in experiments for studies on human and animal diseases
Main category of diseases versus species
Data of 2008 *
| 4.1 Species | 4.2 Human cardiovascular diseases | 4.3 Human nervous and mental disorders | 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5 Other human diseases | 4.6 Studies specific to animal diseases | 4.7 Total |
| 1.a. Mice (Mus musculus) | 249486 | 858612 | 803038 | 1883499 | 292772 | 4087407 |
| 1.b. Rats (Rattus norvegicus) | 125904 | 489630 | 43336 | 600979 | 16909 | 1276758 |
| 1.c. Guinea-Pigs (Cavia porcellus) | 2856 | 5004 | 262 | 47326 | 3252 | 58700 |
| 1.d. Hamsters (Mesocricetus ) | 1940 | 2986 | 791 | 6751 | 3104 | 15572 |
| 1.e. Other Rodents (other Rodentia) | 673 | 6737 | 239 | 5093 | 4617 | 17359 |
| 1.f. Rabbits (Oryctolagus cuniculus) | 5373 | 1386 | 1781 | 28138 | 6983 | 43661 |
| 1.g. Cats (Felis catus) | 14 | 169 | 0 | 126 | 1930 | 2239 |
| 1.h. Dogs (Canis familiaris) | 1233 | 207 | 144 | 4544 | 3810 | 9938 |
| 1.i. Ferrets (Mustela putorius furo) | 20 | 184 | 0 | 2153 | 105 | 2462 |
| 1.j. Other Carnivores (other Carnivore) | 72 | 0 | 0 | 468 | 411 | 951 |
| 1.k. Horses, donkeys and cross breds (Equidae) | 3 | 0 | 0 | 154 | 1614 | 1771 |
| 1.l. Pigs (Sus) | 4638 | 417 | 100 | 9589 | 17299 | 32043 |
| 1.m. Goats (Capra) | 170 | 39 | 87 | 478 | 1014 | 1788 |
| 1.n. Sheep (Ovis) | 597 | 601 | 24 | 8065 | 6833 | 16120 |
| 1.o. Cattle (Bos) | 243 | 36 | 0 | 2860 | 13756 | 16895 |
| 1.p. Prosimians (Prosimia) | 0 | 40 | 0 | 311 | 370 | 721 |
| 1.q. New World Monkeys (Ceboidea) | 7 | 101 | 0 | 419 | 21 | 548 |
| 1.r. Old World Monkeys (Cercopithecoidea) | 111 | 261 | 6 | 3173 | 8 | 3559 |
| 1.s. Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t. Other Mammals (other Mammalia) | 29 | 55 | 5 | 887 | 449 | 1425 |
| 1.u. Quail (Coturnix coturnix) | 0 | 400 | 0 | 177 | 413 | 990 |
| 1.v. Other birds (other Aves) | 4769 | 4563 | 47 | 21365 | 194727 | 225471 |
| 1.w. Reptiles (Reptilia) | 0 | 90 | 0 | 0 | 934 | 1024 |
| 1.x. Amphibians (Amphibia) | 362 | 603 | 2886 | 10852 | 2022 | 16725 |
| 1.y. Fish (Pisces) | 5841 | 57964 | 2458 | 381109 | 40958 | 488330 |
| 1.z. TOTAL | 404341 | 1430085 | 855204 | 3018516 | 614311 | 6322457 |
Table 4.2: Number of animals used in studies of diseases by classes of animals
| Classes of animals | Human Cardiovascular diseases | Human nervous and mental disorder | Human cancer (excl. evaluation of carcino. hazards) | Other human diseases | Specific animal diseases | Total |
| Mice | 249486 | 858612 | 803038 | 1883499 | 292772 | 4087407 |
| Rats | 125904 | 489630 | 43336 | 600979 | 16909 | 1276758 |
| Guinea-Pigs | 2856 | 5004 | 262 | 47326 | 3252 | 58700 |
| Other rodents | 2613 | 9723 | 1030 | 11844 | 7721 | 32931 |
| Rabbits | 5373 | 1386 | 1781 | 28138 | 6983 | 43661 |
| Carnivores | 1339 | 560 | 144 | 7291 | 6256 | 15590 |
| Artio + Perrisodactyla | 5651 | 1093 | 211 | 21146 | 40516 | 68617 |
| Prosimians+Monkeys+Apes | 118 | 402 | 6 | 3903 | 399 | 4828 |
| Other Mammals | 29 | 55 | 5 | 887 | 449 | 1425 |
| Birds | 4769 | 4963 | 47 | 21542 | 195140 | 226461 |
| Cold-blooded animals | 6203 | 58657 | 5344 | 391961 | 43914 | 506079 |
| TOTAL | 404341 | 1430085 | 855204 | 3018516 | 614311 | 6322457 |
| Classes of animals% | Human Cardiovascular diseases | Human nervous and mental disorder | Human cancer (excl. evaluation of carcino. hazards) | Other human diseases | Specific animal diseases | Total |
| Mice | 6,10 | 21,01 | 19,65 | 46,08 | 7,16 | 100,00 |
| Rats | 9,86 | 38,35 | 3,39 | 47,07 | 1,32 | 100,00 |
| Guinea-Pigs | 4,87 | 8,52 | 0,45 | 80,62 | 5,54 | 100,00 |
| Other rodents | 7,93 | 29,53 | 3,13 | 35,97 | 23,45 | 100,00 |
| Rabbits | 12,31 | 3,17 | 4,08 | 64,45 | 15,99 | 100,00 |
| Carnivores | 8,59 | 3,59 | 0,92 | 46,77 | 40,13 | 100,00 |
| Artio + Perrisodactyla | 8,24 | 1,59 | 0,31 | 30,82 | 59,05 | 100,00 |
| Prosimians+Monkeys+Apes | 2,44 | 8,33 | 0,12 | 80,84 | 8,26 | 100,00 |
| Other Mammals | 2,04 | 3,86 | 0,35 | 62,25 | 31,51 | 100,00 |
| Birds | 2,11 | 2,19 | 0,02 | 9,51 | 86,17 | 100,00 |
| Cold-blooded animals | 1,23 | 11,59 | 1,06 | 77,45 | 8,68 | 100,00 |
Species of Table 4.1 were grouped into classes of animals and presented in Table 4.2. The relative percentage of animals per class of species used in studies by type of disease has been calculated and is also presented in the lower part of Table 4.2.
Figure 4.2 presents the proportion of animals used by classes per type of studies of diseases.
The top of each bar shows the relative percentage of animals used for studies on specific animal diseases. Significant numbers of both artiodactyla and perissodactyla and birds are used for this purpose. Member States reported that it is still current practice to test vaccines on these species. However, in some Member States only birds are used if the infection concerns bird species.
The data on the use of most species for all types of studies on both human and animal diseases show a great similarity to the data of 2005. However, there is a substantial decrease in the use of ‘other mammals’ for studies of human diseases in particular other human diseases, whereas the opposite is observed for cold-blooded animals which have been more widely used in studies on human diseases rather than animal diseases.
III.6. Results of EU Table 5: Animals used in production and quality control of products for human medicine and dentistry and for veterinary medicine
III.6.1. The data on animals used in production and quality control of products for human medicine and dentistry and for veterinary medicine
The consolidated table for the 27 Member States reporting the origin of the regulatory requirements in relation to animals used for the production and quality control of products for human medicine and dentistry and for veterinary medicine (EU Table 5) is presented in Table 5.1 at the end of this chapter.
III.6.2. Treatment and interpretation of the data
The number of animals used in tests for the production and quality control of products for human medicine and dentistry and for veterinary medicine represents 14,9% of the total number of animals used for experimental purposes. Figure 5 gives the percentages of the animals used to satisfy the different regional regulatory requirements in this area.
The largest proportion of animals in this area (47%) was used to satisfy requirements from several pieces of legislation (from national, the EU, the Council of Europe member country legislation, and from legislation outside of the EU (Fig 5)). The testing carried out to satisfy EU legislation including the European Pharmacopoeia covered 41,1% of the animals used in this area.
In comparison to the report of 2005 there is a net decrease in the number of animals used to satisfy simultaneously several pieces of legislation. On the other hand there is a net increase of tests carried out for the European legislation (including the European Pharmacopoeia).
Consequently, there is a net decrease in the number of animals used to satisfy national legislation, which is an encouraging trend showing an attempt to move towards EU harmonisation of regulatory requirements.
Table 5.1: Number of animals used in the production and quality control of products and devices for human medicine and dentistry and for veterinary medicine
Regulatory requirements versus species
Data of 2008 *
| 5.1. Species | 5.2. National legislation specific to a single EC Member State1 | 5.3. EC legislation including European Pharmacopoeia (requirements) | 5.4. Member Country of Council of Europe (but not EC) legislation2) | 5.5. Other legislation | 5.6. Any combination of 5.2/ 5.3/ 5.4/ 5.5 | 5.7. No regulatory requirements | 5.8. Total |
| 1.a. Mice (Mus musculus) | 33233 | 359722 | 371 | 21567 | 569279 | 43303 | 1027475 |
| 1.b. Rats (Rattus norvegicus) | 5107 | 86403 | 405 | 16406 | 105741 | 5319 | 219381 |
| 1.c. Guinea-Pigs (Cavia porcellus) | 2519 | 43916 | 0 | 6494 | 62550 | 5615 | 121094 |
| 1.d. Hamsters (Mesocricetus ) | 0 | 8916 | 0 | 358 | 3613 | 2 | 12889 |
| 1.e. Other Rodents (other Rodentia) | 0 | 0 | 0 | 0 | 30 | 0 | 30 |
| 1.f. Rabbits (Oryctolagus cuniculus) | 851 | 107271 | 0 | 1077 | 53039 | 20539 | 182777 |
| 1.g. Cats (Felis catus) | 43 | 614 | 0 | 8 | 58 | 10 | 733 |
| 1.h. Dogs (Canis familiaris) | 208 | 985 | 0 | 0 | 982 | 55 | 2230 |
| 1.i. Ferrets (Mustela putorius furo) | 0 | 2 | 0 | 0 | 522 | 48 | 572 |
| 1.j. Other Carnivores (other Carnivore) | 27 | 311 | 0 | 0 | 0 | 0 | 338 |
| 1.k. Horses, donkeys and cross breds (Equidae) | 307 | 225 | 0 | 0 | 164 | 2087 | 2783 |
| 1.l. Pigs (Sus) | 518 | 5436 | 0 | 91 | 2385 | 994 | 9424 |
| 1.m. Goats (Capra) | 68 | 27 | 0 | 3 | 10 | 11 | 119 |
| 1.n. Sheep (Ovis) | 805 | 1523 | 54 | 5 | 703 | 5079 | 8169 |
| 1.o. Cattle (Bos) | 139 | 2500 | 0 | 6 | 414 | 469 | 3528 |
| 1.p. Prosimians (Prosimia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.q. New World Monkeys (Ceboidea) | 0 | 0 | 0 | 0 | 33 | 0 | 33 |
| 1.r. Old World Monkeys (Cercopithecoidea) | 0 | 0 | 0 | 0 | 231 | 0 | 231 |
| 1.s. Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t. Other Mammals (other Mammalia) | 13 | 50 | 0 | 0 | 0 | 28 | 91 |
| 1.u. Quail (Coturnix coturnix) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.v. Other birds (other Aves) | 1887 | 117540 | 60 | 1676 | 41194 | 7556 | 169913 |
| 1.w. Reptiles (Reptilia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.x. Amphibians (Amphibia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.y. Fish (Pisces) | 2260 | 1430 | 0 | 0 | 406 | 24137 | 28233 |
| 1.z. TOTAL | 47985 | 736871 | 890 | 47691 | 841354 | 115252 | 1790043 |
(*) France reporting for 2007
| Examples: | 5.2 - France is testing due to a UK (or FR) specific requirement | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out | |
| 5.3 - UK is testing according to EC legislation | and not to the body which has issued the actual test method, guideline or protocol | |||
| 5.4 - Spain is testing due to a Norwegian requirement | Example: | a test required by French legislation and carried out in Belgium according to an | ||
| 5.5 – Poland is testing due to a US specific requirement | ISO protocol must be coded as a national (FR) legislative requirement and be | |||
| 5.6 - Germany is testing due to a Swiss requirement (also an EC requirement) | entered into column 5.2 in the tables submitted by Belgium. | |||
| Footnotes: | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech 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 |
III.7. Results of EU harmonized Table 6: Origin of regulatory requirements for animals used in toxicological and other safety evaluations
III.7.1. The data on the origin of regulatory requirements for animals used in toxicological and other safety evaluations
The consolidated table for the 27 Member States reporting data on animals used in toxicological and other safety evaluations in relation to the origin of regulatory requirements (EU Table 6) is presented in Table 6.1 at the end of this chapter.
III.7.2. Treatment and interpretation of the data
The use of animals for the regulatory requirements of different regions in the area of toxicological or other safety evaluation presented in Figure 6 follows a similar pattern to that of the use of animals used for regulatory purposes in human medicine, dentistry and in veterinary medicine in different regions, presented in the Figure 5 in the previous chapter.
As pointed out earlier, the number of animals used in toxicological or other safety evaluation represents 8,7% of the total number of animals used for experimental purposes in the EU.
Animals used to simultaneously satisfy regulatory requirements from several pieces of legislation covered almost half of the animals used in this area (50%). The testing required under EU legislation including the European Pharmacopoeia accounts for the second highest percentage in this area, namely 24%.
The increase of the numbers of animals used for toxicological and other safety evaluations since the last report is relatively low and represents about 15,800 animals.
In comparison to the last report there is a net slight decrease in the proportion of animals used to simultaneously satisfy several pieces of regional legislation from 54% to nearly 50%.
However, there is a substantial increase in the proportion of animals used for no regulatory requirements. In order to explain what is meant by the term no regulatory requirements, some Member States gave as an example projects using in-house methods to verify the safety and efficacy of veterinary biologicals and medicinal products using animals, and carried out according to a company’s standards. The results may be accepted by that Member State national authority, although not required by legislation.
The testing carried out in 2008 to satisfy national legislation specific to a single Member State showed a decrease of about 7,500 animals which represents roughly a 1% decrease compared to the last report.
Table 6.1: Number of animals used in toxicological and other safety evaluations
Regulatory requirements versus species
Data of 2008*
| 6.1. Species | 6.2. National legislation specific to a single EC Member State1) | 6.3. EC legislation including European Pharmacopoeia (requirements) | 6.4. Member Country of Council of Europe (but not EC) legislation2) | 6.5. Other legislation | 6.6. Any combination of 5.2/ 5.3/ 5.4/ 5.5 | 6.7. No regulatory requirements | 6.8.Total |
| 1.a. Mice (Mus musculus) | 35721 | 129353 | 752 | 5034 | 198942 | 28397 | 398199 |
| 1.b. Rats (Rattus norvegicus) | 17191 | 51343 | 89 | 11496 | 194371 | 20093 | 294583 |
| 1.c. Guinea-Pigs (Cavia porcellus) | 660 | 14723 | 84 | 390 | 15166 | 960 | 31983 |
| 1.d. Hamsters (Mesocricetus ) | 101 | 238 | 0 | 0 | 1106 | 135 | 1580 |
| 1.e. Other Rodents (other Rodentia) | 204 | 0 | 0 | 0 | 191 | 0 | 395 |
| 1.f. Rabbits (Oryctolagus cuniculus) | 1179 | 12694 | 2 | 1744 | 23426 | 942 | 39987 |
| 1.g. Cats (Felis catus) | 97 | 126 | 4 | 0 | 85 | 10 | 322 |
| 1.h. Dogs (Canis familiaris) | 626 | 1421 | 58 | 769 | 8023 | 180 | 11077 |
| 1.i. Ferrets (Mustela putorius furo) | 211 | 32 | 0 | 26 | 0 | 0 | 269 |
| 1.j. Other Carnivores (other Carnivore) | 296 | 0 | 0 | 0 | 0 | 0 | 296 |
| 1.k. Horses, donkeys and cross breds (Equidae) | 0 | 0 | 0 | 0 | 1 | 21 | 22 |
| 1.l. Pigs (Sus) | 172 | 1177 | 8 | 181 | 6102 | 425 | 8065 |
| 1.m. Goats (Capra) | 29 | 0 | 0 | 0 | 14 | 0 | 43 |
| 1.n. Sheep (Ovis) | 2 | 75 | 0 | 0 | 322 | 10 | 409 |
| 1.o. Cattle (Bos) | 10 | 226 | 0 | 44 | 173 | 0 | 453 |
| 1.p. Prosimians (Prosimia) | 0 | 543 | 0 | 0 | 0 | 0 | 543 |
| 1.q. New World Monkeys (Ceboidea) | 0 | 0 | 0 | 0 | 246 | 24 | 270 |
| 1.r. Old World Monkeys (Cercopithecoidea) | 0 | 265 | 0 | 732 | 4599 | 98 | 5694 |
| 1.s. Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t. Other Mammals (other Mammalia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.u. Quail (Coturnix coturnix) | 24 | 680 | 0 | 0 | 1466 | 0 | 2170 |
| 1.v. Other birds (other Aves) | 10 | 7406 | 0 | 5000 | 36017 | 2798 | 51231 |
| 1.w. Reptiles (Reptilia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.x. Amphibians (Amphibia) | 0 | 0 | 0 | 0 | 179 | 112 | 291 |
| 1.y. Fish (Pisces) | 32582 | 29413 | 0 | 1517 | 27071 | 103688 | 194271 |
| 1.z. TOTAL | 89115 | 249715 | 997 | 26933 | 517500 | 157893 | 1042153 |
(*)France is reporting for 2007
| Examples: | 6.2 - France is testing due to a UK (or FR) specific requirement | Note: | 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 | |
| 6.3 - UK is testing according to EC legislation | ||||
| 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 |
III.8. Results of EU Table 7: Animals used in toxicity tests for toxicological and other safety evaluations
III.8.1. The data on animals used in toxicity test for toxicological and other safety evaluations
The consolidated table for the 27 Member States reporting on animals used in toxicity tests for the purpose of toxicological and other safety evaluations of products (EU Table 7) is presented in Table 7.1 at the end of this chapter.
III.8.2. Treatment and interpretation of the data
For the convenience of the presentation of results some of the toxicity tests of Table 7.1 have been grouped according to systemic and local toxicity and CMR (carcinogenicity, mutagenicity and toxicity to reproduction) effects in Table 7.2. A graph showing the percentage of animals used per toxicity test groups in 2008 is presented in Figure 7.
As pointed out in the previous chapter, the number of animals used in toxicological and other safety evaluations represents 8,7% of the total number of animals used for experimental purposes.
In Figure 7 the largest percentage (almost 45%) of use of animals in toxicological and other safety evaluations is due to acute and sub-acute toxicity tests. Also taking into account sub-chronic and chronic toxicity, the percentage of animals used in short and long term systemic toxicity testing accounts for 55% in this area.
13,7% of animals were used for testing carcinogenicity, mutagenicity and toxicity to reproduction. Another important category of use of animals in 2008 is for other tests with 24%. Breaking down further the category other, Member States reported testing in areas such as biological screening for pharmaceutical, healthcare and veterinary products. This includes neurotoxicity, toxicokinetics, testing of biological evaluation of medical devices: Intracutaneous testing of reactivity in rabbits, studies into the penetration of nanoparticles through tissue and their biocompatibility, studies into the evaluation of sensitization potential of dyestuffs used in the textile industry and pharmacological studies included in safety tests.
By looking both in numbers and relative percentages of use of animals in comparison to the previous reports there are two noticeable changes:
There is a continuous increase over the last three reports of the proportion of animals used for acute and sub-acute tests, ranging from 36% - 42% to almost 45% respectively. This represents in animal numbers an increase of more than 37,000 animals since the last report. Member States attributed the increase in part to several phases in new product development and new legislation, for example requiring that all generic substances should be tested.
On the other hand one can observe a steady decrease over the last three reports of the animals used for reproductive toxicity testing from: 12% to 10% and to 9% respectively. This demonstrates a saving since the 2005 report of 8,650 animals.
A general decrease in the number of animals used for regulatory toxicological evaluation could be attributed to the use of alternative methods according to some Member States. However, others have suggested that replacement methods have a much greater impact on research and development than on regulatory requirements.
Table 7.1: Number of animals used in toxicological and other safety evaluations
Type of tests versus species
Data of 2008*
| 7.1. Species | 7.2. Acute and sub-acute toxicity testing methods (including limit test) | 7.3. Skin irritation | 7.4. Skin sensitisation | 7.5. Eye irritation | 7.6. Sub- chronic and chronic toxicity | 7.7. Carcino- genicity | 7.8. Develop- mental toxicity | 7.9. Muta- genicity | 7.10. Repro-ductive toxicity | 7.11. Toxicity to aquatic vertebra-tes not included in other columns | 7.12. Other | 7.13. Total | ||
| 7.2.1. LD50, LC50 | 7.2.2. Other lethal methods | 7.2.3. Non lethal clinical signs methods | ||||||||||||
| 1.a. Mice (Mus musculus) | 87440 | 87455 | 46654 | 926 | 16742 | 30 | 27173 | 10375 | 3744 | 12858 | 2759 | 200 | 101843 | 398199 |
| 1.b. Rats (Rattus norvegicus) | 7060 | 12651 | 74924 | 768 | 1465 | 78 | 54915 | 10219 | 20263 | 14043 | 51314 | 26 | 46957 | 294683 |
| 1.c. Guinea-Pigs (Cavia porcellus) | 1000 | 303 | 3363 | 140 | 20198 | 6 | 618 | 0 | 120 | 0 | 101 | 7 | 6027 | 31883 |
| 1.d. Hamsters (Mesocricetus ) | 16 | 0 | 343 | 22 | 0 | 0 | 310 | 0 | 0 | 21 | 0 | 0 | 868 | 1580 |
| 1.e. Other Rodents (other Rodentia) | 27 | 0 | 0 | 0 | 0 | 0 | 204 | 0 | 0 | 0 | 0 | 0 | 164 | 395 |
| 1.f. Rabbits (Oryctolagus cuniculus) | 110 | 38 | 5875 | 4200 | 32 | 2105 | 1240 | 0 | 6047 | 0 | 5349 | 7 | 14984 | 39987 |
| 1.g. Cats (Felis catus) | 0 | 0 | 24 | 0 | 0 | 0 | 62 | 0 | 0 | 0 | 0 | 0 | 236 | 322 |
| 1.h. Dogs (Canis familiaris) | 15 | 339 | 4637 | 0 | 0 | 0 | 4582 | 0 | 0 | 0 | 20 | 0 | 1484 | 11077 |
| 1.i. Ferrets (Mustela putorius furo) | 0 | 0 | 211 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 58 | 269 |
| 1.j. Other Carnivores (other Carnivore) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 296 | 296 |
| 1.k. Horses, donkeys and cross breds (Equidae) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 22 | 22 |
| 1.l. Pigs (Sus) | 0 | 11 | 535 | 115 | 0 | 0 | 937 | 0 | 0 | 0 | 112 | 0 | 6355 | 8065 |
| 1.m. Goats (Capra) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 43 | 43 |
| 1.n. Sheep (Ovis) | 0 | 0 | 36 | 0 | 0 | 0 | 34 | 0 | 0 | 0 | 0 | 0 | 339 | 409 |
| 1.o. Cattle (Bos) | 0 | 0 | 60 | 0 | 0 | 0 | 12 | 0 | 0 | 0 | 22 | 0 | 359 | 453 |
| 1.p. Prosimians (Prosimia) | 0 | 0 | 261 | 0 | 0 | 0 | 143 | 0 | 0 | 0 | 0 | 0 | 139 | 543 |
| 1.q. New World Monkeys (Ceboidea) | 0 | 0 | 65 | 0 | 0 | 0 | 71 | 0 | 64 | 0 | 0 | 0 | 70 | 270 |
| 1.r. Old World Monkeys (Cercopithecoidea) | 18 | 0 | 1735 | 0 | 0 | 0 | 2861 | 0 | 176 | 0 | 58 | 0 | 846 | 5694 |
| 1.s. Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t. Other Mammals (other Mammalia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.u. Quail (Coturnix coturnix) | 819 | 241 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 176 | 0 | 934 | 2170 |
| 1.v. Other birds (other Aves) | 456 | 135 | 5937 | 1020 | 0 | 65 | 0 | 0 | 0 | 0 | 108 | 0 | 43510 | 51231 |
| 1.w. Reptiles (Reptilia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.x. Amphibians (Amphibia) | 0 | 0 | 0 | 0 | 0 | 0 | 108 | 0 | 4 | 0 | 0 | 0 | 179 | 291 |
| 1.y. Fish (Pisces) | 50983 | 70000 | 5110 | 119 | 0 | 0 | 9735 | 213 | 868 | 0 | 3796 | 24857 | 28590 | 194271 |
| 1.z. TOTAL | 147944 | 171173 | 149770 | 7310 | 38437 | 2284 | 103005 | 20807 | 31286 | 26922 | 63815 | 25097 | 254303 | 1042153 |
(*) France reporting for 2007
Table 7.2: Grouping of certain type of tests on animals of table 7.1
| 7.1. Species | Acute and sub-acute toxicity testing methods (including limit test) | Irritation /sensitization tests | Sub- chronic and chronic toxicity | Mutagenicity and carcinogenicity | Reproductive and developmental toxicity | Toxicity to aquatic vertebrates not included in other columns | other | Total |
| 1.a. Mice (Mus musculus) | 221549 | 17698 | 27173 | 23233 | 6503 | 200 | 101843 | 398199 |
| 1.b. Rats (Rattus norvegicus) | 94635 | 2311 | 54915 | 24262 | 71577 | 26 | 46957 | 294683 |
| 1.c. Guinea-Pigs (Cavia porcellus) | 4666 | 20344 | 618 | 0 | 221 | 7 | 6027 | 31883 |
| 1.d. Hamsters (Mesocricetus ) | 359 | 22 | 310 | 21 | 0 | 0 | 868 | 1580 |
| 1.e. Other Rodents (other Rodentia) | 27 | 0 | 204 | 0 | 0 | 0 | 164 | 395 |
| 1.f. Rabbits (Oryctolagus cuniculus) | 6023 | 6337 | 1240 | 0 | 11396 | 7 | 14984 | 39987 |
| 1.g. Cats (Felis catus) | 24 | 0 | 62 | 0 | 0 | 0 | 236 | 322 |
| 1.h. Dogs (Canis familiaris) | 4991 | 0 | 4582 | 0 | 20 | 0 | 1484 | 11077 |
| 1.i. Ferrets (Mustela putorius furo) | 211 | 0 | 0 | 0 | 0 | 0 | 58 | 269 |
| 1.j. Other Carnivores (other Carnivore) | 0 | 0 | 0 | 0 | 0 | 0 | 296 | 296 |
| 1.k. Horses, donkeys and cross breds (Equidae) | 0 | 0 | 0 | 0 | 0 | 0 | 22 | 22 |
| 1.l. Pigs (Sus) | 546 | 115 | 937 | 0 | 112 | 0 | 6355 | 8065 |
| 1.m. Goats (Capra) | 0 | 0 | 0 | 0 | 0 | 0 | 43 | 43 |
| 1.n. Sheep (Ovis) | 36 | 0 | 34 | 0 | 0 | 0 | 339 | 409 |
| 1.o. Cattle (Bos) | 60 | 0 | 12 | 0 | 22 | 0 | 359 | 453 |
| 1.p. Prosimians (Prosimia) | 261 | 0 | 143 | 0 | 0 | 0 | 139 | 543 |
| 1.q. New World Monkeys (Ceboidea) | 65 | 0 | 71 | 0 | 64 | 0 | 70 | 270 |
| 1.r. Old World Monkeys (Cercopithecoidea) | 1753 | 0 | 2861 | 0 | 234 | 0 | 846 | 5694 |
| 1.s. Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t. Other Mammals (other Mammalia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.u. Quail (Coturnix coturnix) | 1060 | 0 | 0 | 0 | 176 | 0 | 934 | 2170 |
| 1.v. Other birds (other Aves) | 6528 | 1085 | 0 | 0 | 108 | 0 | 43510 | 51231 |
| 1.w. Reptiles (Reptilia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.x. Amphibians (Amphibia) | 0 | 0 | 108 | 0 | 4 | 0 | 179 | 291 |
| 1.y. Fish (Pisces) | 126093 | 119 | 9735 | 213 | 4664 | 24857 | 28590 | 194271 |
| 1.z. TOTAL | 468887 | 48031 | 103005 | 47729 | 95101 | 25097 | 254303 | 1042153 |
III.9. Results of EU Table 8: Type of toxicity tests carried out for toxicological and other safety evaluations of products
III.9.1. The data on type of toxicity tests carried out for toxicological and other safety evaluations of products
The consolidated table for the type of toxicity tests carried out for toxicological or other safety evaluations of products for the 27 Member States reporting (EU table 8) is presented in table 8.1 of this report. The data in table 8 have been subjected to a further quality criteria check developed by the Commission. The data provided by all Member States for this report were coherent.
III.9.2. Treatment and interpretation of the data
As pointed out earlier, animals used in toxicological and other safety evaluation represent 8,7% of the total number of animals used for experimental purposes.
In order to facilitate the interpretation of the results some types of toxicity testing have been grouped and the results can be found in consolidated table 8.2 at the end of this chapter. Figure 8 gives the proportion of animals used for toxicity and other safety evaluation by types of products.
The treatment and interpretation of the data on animals used for toxicity tests with regard to the type of products was done for the first time in the Fifth Statistical Report. However, because the graph in that report represented more the relative importance of tests within a type of product rather than the proportion of animals used per type of test for the different products, the graph was modified accordingly for this report.
Figure 8 shows that the majority of animals tested in acute/sub-acute toxicity are intended for the purpose of human medicine, dentistry and veterinary medicine. This is followed by tests carried out for other toxicological or safety evaluation and then for agriculture and industrial products.
Products intended for medicine, dentistry and veterinary medicine require the highest proportion of animals for the different types of tests i.e. approximately 50%. The next highest proportion is for ‘other’ toxicological evaluations, above 20%, followed by animals used in tests for products for agriculture and industry each above 7%.
Table 8.1: Number of animals used in toxicological and other safety evaluations
Type of tests versus products
Data of 2008*
| 8.1. Products | 8.2. Acute and sub-acute toxicity testing methods (including limit test) | 8.3. Skin irritation | 8.4. Skin sensitisation | 8.5. Eye irritation | 8.6. Sub- chronic and chronic toxicity | 8.7. Carcino- genicity | 8.8. Develop- mental toxicity | 8.9. Muta- genicity | 8.10. Repro-ductive toxicity | 8.11. Toxicity to aquatic vertebra-tes not included in other columns | 8.12. Other | 8.13. Total | ||
| 8.2.1. LD50, LC50 | 8.2.2. Other lethal methods | 8.2.3. Non lethal clinical signs methods | ||||||||||||
| 8.a. Products/ substances or devices for human medicine and dentistry and for veterinary medicine | 43643 | 85795 | 116481 | 3732 | 17719 | 506 | 62442 | 15063 | 12314 | 14286 | 37079 | 3917 | 116640 | 529617 |
| 8.b. Products/ substances used or intended to be used mainly in agriculture | 9066 | 4192 | 4987 | 724 | 4252 | 581 | 10089 | 3590 | 3120 | 2224 | 11578 | 11884 | 7860 | 74147 |
| 8.c. Products/ substances used or intended to be used mainly in industry | 5263 | 4832 | 12483 | 2368 | 11129 | 1001 | 8324 | 306 | 11475 | 6490 | 8863 | 2870 | 7022 | 82426 |
| 8.d. Products/ substances used or intended to be used mainly in the household | 617 | 1636 | 50 | 143 | 0 | 27 | 159 | 0 | 0 | 114 | 1016 | 0 | 520 | 4282 |
| 8.e. Products/ substances used or intended to be used mainly as cosmetics or toiletries | 822 | 207 | 98 | 87 | 699 | 54 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1967 |
| 8.f. Products/ substances used or intended to be used mainly as additives in food for human consumption | 64 | 112 | 213 | 3 | 0 | 6 | 1421 | 649 | 3157 | 320 | 167 | 0 | 128 | 6240 |
| 8.g. Products/ substances used or intended to be used mainly as additives in food for animal consumption | 0 | 9142 | 177 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 0 | 80 | 44665 | 54164 |
| 8.h. Potential or actual contaminants in the general environment which do not appear in other columns | 37714 | 6243 | 2206 | 119 | 0 | 0 | 6294 | 213 | 85 | 1502 | 4111 | 4713 | 3410 | 66610 |
| 8.i. Other toxicological or safety evaluations | 10080 | 60404 | 7909 | 173 | 1797 | 94 | 8004 | 2625 | 319 | 2937 | 3176 | 1234 | 123948 | 222700 |
| 8.j. TOTAL | 107269 | 172563 | 144604 | 7349 | 35596 | 2269 | 96833 | 22446 | 30470 | 27873 | 65990 | 24698 | 304193 | 1042153 |
(*) France reporting for 2007
Table 8.2: Number of animals used in toxicological and other safety evaluation per types of products
| 8.1. Products | Acute and sub-acute toxicity testing methods (including limit test) | Irritation/sensitization tests | Sub- chronic and chronic toxicity | carcinogenicity, Mutagenicity and Reprotox. | Toxicity to aquatic vertebrates not included in other columns | Other | Total |
| 8.a. Products/ substances or devices for human medicine and dentistry and for veterinary medicine | 245919 | 21957 | 62442 | 78742 | 3917 | 116640 | 529617 |
| 8.b. Products/ substances used or intended to be used mainly in agriculture | 18245 | 5557 | 10089 | 20512 | 11884 | 7860 | 74147 |
| 8.c. Products/ substances used or intended to be used mainly in industry | 22578 | 14498 | 8324 | 27134 | 2870 | 7022 | 82426 |
| 8.d. Products/ substances used or intended to be used mainly in the household | 2303 | 170 | 159 | 1130 | 0 | 520 | 4282 |
| 8.e. Products/ substances used or intended to be used mainly as cosmetics or toiletries | 1127 | 840 | 0 | 0 | 0 | 0 | 1967 |
| 8.f. Products/ substances used or intended to be used mainly as additives in food for human consumption | 389 | 9 | 1421 | 4293 | 0 | 128 | 6240 |
| 8.g. Products/ substances used or intended to be used mainly as additives in food for animal consumption | 9319 | 0 | 100 | 0 | 80 | 44665 | 54164 |
| 8.h. Potential or actual contaminants in the general environment which do not appear in other columns | 46163 | 119 | 6294 | 5911 | 4713 | 3410 | 66610 |
| 8.i. Other toxicological or safety evaluations | 78393 | 2064 | 8004 | 9057 | 1234 | 123948 | 222700 |
| 8.j. TOTAL | 424436 | 45214 | 96833 | 146779 | 24698 | 304193 | 1042153 |
1OJ L 358, 18.12.1986, p.1.
2COM (94) 195 final
3COM (1999) 191 final
4COM (2003) 19 final
5COM (2005) 7 final
6COM (2007) 675 final
7OJ C 331, 23.12.86, p. 2.
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