Slov Vet Res 2009; 46 (2): 47-60 UDC 636.025:34-179.3(497.12)(4) Review Paper RECORDS ON THE USE OF ANIMALS IN EXPERIMENTS IN THE REPUBLIC OF SLOVENIA AND IN OTHER EU MEMBER STATES WITHIN A 15-YEAR PERIOD Dragica Ornik*, Vida Cadonic-Spelic Veterinary Administration of the Republic of Slovenia, Parmova 53, 1000 Ljubljana, Slovenia Corresponding author, E-mail: dragica.ornik@gov.si Summary: Scope of this paper is to present data on the number and species of animals used in experiments and on the purposes of use of animals in the Republic of Slovenia and in the European Union within a 15-year period. According to data collected in the particular years of the period from 1992 to 2006 on the use of animals in experiments in the Republic of Slovenia, the trend of the use of animals in experiments has been found to be on the decline. The total number of experimental animals in 1992 amounted to 37,212, and in 2006 to 13,181 only. In the Republic of Slovenia, the use of experimental animals in applied research shows a downward trend on account of validated alternative methods in use, which do not require animals. In the most recent years in particular, the Slovenian legislative activity in the field of protection of experimental animals has been most productive with the scope of harmonising the Slovenian legislation with the EU law. The European Commission published five reports on the use of animals in experiments. The total number of experimental animals as reported by the EU Member States amounted to 11.79 million in 1991, to 11.64 million in 1996, to 9.81 million in 1999, to 10.73 million in 2002, and to 12.11 million in 2005. The first two reports provided a limited scope of analysis due to the absence of a consistent system of reporting the data on the use of experimental animals in the Member States. The third and the fourth reports were based on agreed harmonized tables. This facilitated a more extensive interpretation of results on the use of experimental animals in the EU, despite some inconsistencies in the data submitted by the Member States. The second report covered for the first time the data collected by the 3 new Member States, and the fifth report by the 10 new Member States. However, it is not possible to draw conclusions on the evolution of use of animals for experimental purposes in the EU by comparing these data with those of the previous reports. The total number includes different animal species, from cold-blooded vertebrates on the one side, to mammals on the other, including farmed animals or anthropoid primates as used in some Member States. Comparison between the national reports is rendered impossible on account of the non-aligned methods of reporting by the EU Member States. These reports give a general survey only of the use of animals in experiments at Community level. Key words: experimental animals; legislation; report Background In Europe and in other developed countries, methods are sought which would decrease the use of animals in experiments. Significant international development in regulating the protection of experimental animals was perceived at adoption of the European Convention (1) and Directive (2, 3). By Decision of the Received: 24 December 2008 Accepted for publication: 13 May 2009 Council of Europe 1999/575/EC (4), the Community was signatory to the Convention of the Council of Europe, ETS 123 (1), increasing thereby its commitment to endeavours of replacing experimental animals and protecting those still used in experiments. The objective of Directive (2) and European Convention (1) was to provide for the harmonisation of provisions on the protection of experimental animals in the national legislations of the Member States. By complying with the proposed standards, the disparities would be abolished, and the measures for 48 D. Ornik, V. Cadonic-Spelic the protection of experimental animals harmonised in providing for the adequate conditions of rearing, care and use and, in particular, to avoid the unnecessary duplications of experiments on animals, by complying with the uniform standards and mutual recognition of test results obtained by experiments already conducted on animals. The requirement that experiments on animals shall not be conducted if another acceptable, feasible and scientifically satisfactory method is available, which does not require the use of experimental animals, has contributed to a decreased use of experimental animals and stimulated the development of alternative methods for experiments on animals. In 1991, the European Centre for the Validation of Alternative Methods - ECVAM was set up in Italy, which directly contributes to the protection of animals, using the 3 R concept (Replacement, Reduction, Refinement) and providing for the validation of alternative methods (5). Greater significance is awarded to the implementation and monitoring of policies in the different spheres of consumer protection and safety testing of chemicals, cosmetic products, biocides, foodstuffs, biological substances and medical devices. At implementation of relevant legislation on safety testing, the alternative methods, which exclude the use of experimental animals, are becoming more and more important. One of the seven main objectives of the action plan of the future policy on chemicals, set out in the White Paper of2001 (6), is to support the developing of tests requiring no use of animals. Alternative methods can produce_reliable information in the most up-to-date and proven tests, which are more rapid and cost-effective than the existing experiments on animals. It has been estimated that the requirements (expenses and animals) for experiments within the REACH Programme (Registration, Evaluation and Authorisation of Chemicals) - including the registration, valuation, authorisation and restriction of chemicals, could decrease by 70 % if using the intelligent strategies for testing (7). A final goal is to replace_experiments on animals with methods that do not require the use of animals. At experiments which still do require the use of live animals, the goal is to decrease the number of animals used, and to improve the methods so as to cause less pain, suffering and harm. Activities towards the full implementation of the 3 R concept need to proceed in all the spheres of use of animals, the harmonisation of Directive 86/609/ EEC (2) and legislation requiring experiments on animals shall be fully implemented, and agreements on the mutual acceptability and recognition of data shall be subjected to scrutiny. Setting up a Community Reference Laboratory for the validation of alternative methods shall additionally improve the quality of alternative methods for testing, and speed up the validation procedure (6, 7). Legal basis for data collection on experimental animals In Slovenia, the Veterinary Administration of the Republic of Slovenia keeps records based on annual reports by the user organisations, in compliance with Article 24 of the Animal Protection Act (8). In 2004, the methods of collecting data on experimental animals were laid down in the Rules (9, 10). Pending the entry into force of these Rules, the data were collected from the reports submitted by scientists performing a particular experiment. Using a questionnaire prepared to this end and partly summing up the European Convention, Appendix B (1), and including the visits to user organisations, data were gathered for the period from 1992 to 1996, and presented to the public for the first time in 1999 (11, 12). Data collected on entry into force of the Animal Protection Act (8) were made available to the public and to all the applicants as public information (13). Based on Article 13 of Council Directive 86/609/ EEC (2), the competent authorities of the EU Member States collect and make available to the public the statistical data on the use of animals in experiments. In Article 26, the said Directive is laying down that the European Commission shall prepare regular reports for the Council and the European Parliament, using the data presented by the EU Member States. As the Directive does not lay down the form and scope of reporting, a common form was unanimously adopted to this end after the multi-annual discussions of the national competent authorities. The European Union requires the reporting to be performed using eight tables, called the EU Tables. The European Convention (1) requires the member states of the Council of Europe to provide reports in five tables, called the Convention Tables. The reservation of the European Community as to the reporting remained unchanged in Council Decision 2003/584/ EC (14) that is laying down the simplified procedure of amending the Appendices to the European Convention. The Republic of Slovenia, having ratified the European Convention in 2006 (15), provided as well for a reservation in accordance with Article 34 to the effect that it did not consider itself bound by the requirement of reporting statistical data. Records on the use of animals in experiments in the Republic of Slovenia and in other EU member states... 49 Data on experimental animals used in the Republic of Slovenia in a 15-year period Table 1 shows data on experimental animals used in the Republic of Slovenia in a 15-year period, collected by the Veterinary Administration of the Republic of Slovenia. In 1992, the number of experimental animals totalled 37,212, as compared to 2006 with 13,181 animals only, which is by 65 % less. Most used were the laboratory mice, followed by laboratory rats and rabbits. Within the first five years of data collection on experimental animals there stands out a high number of poultry. The numbers include also the poultry used in nutritional experiments under the normal rearing conditions and without the invasive treatment of animals. Such use of poultry was excluded from the subsequent reports. Table 1 includes a column on the protected animal species that are protected in the Republic of Slovenia in accordance with the Decree (16, 17). Of the protected animal species, mostly the amphibians (frogs) were used in experiments. Most experiments are conducted on laboratory rodents in pharmaceutical industry for substance testing, and are carried out in accordance with the applicable legislation, the rules of pharmacopoeias applied, and international laws, regulations and administrative provisions. This information is evident from Table 2. Institutes and laboratories of university faculties of the medical, veterinary, biological and zootechnical programmes use animals in the baseline biological research, and in scientific and research studies. To a lesser extent, animals are used for diagnosing diseases, training and education, and for other purposes that are not particularly specified. Table 1: Number and species of animals used in experiments in the Republic of Slovenia in the period from 1992 to 2006 Species 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 Mice (Mus musculus) 19,754 16,475 15,555 16,274 15,163 15,233 11,796 12,900 10,394 9,773 9,024 8,388 7,560 8,556 7,590 Rats (Rattus norvegicus) 7,458 6,472 5,974 5,659 5,066 4,011 4,387 3,261 4,284 3,504 3,201 3,056 4,429 2,732 4,767 Guinea Pigs (Cavia porcellus) 532 553 450 567 482 400 468 139 79 50 112 120 121 38 26 Hamsters (Mesocricetus) 0 0 0 0 0 10 3 0 0 0 0 0 0 0 0 Other Rodents (other Rodentia) 6 86 0 0 0 10 0 0 177 35 18 0 Rabbits (Oryctolagus cuniculus) 1,251 1,207 1,387 909 1,451 1,107 1,439 781 744 712 795 597 582 533 472 Cats (Felis catus) 43 50 50 57 29 60 50 83 55 44 38 0 1 0 0 Dogs (Canis familiaris) 19 52 44 18 19 14 17 21 3 12 14 34 7 15 6 Horses, donkeys, crossbreeds (Equidae) 10 0 1 0 0 1 1 4 26 1 0 Pigs (Sus) 22 22 40 26 27 69 239 82 246 29 106 6 11 16 0 Goats (Capra) 0 0 0 10 60 0 0 0 0 0 Sheep (Ovis) 19 21 21 19 17 35 22 21 36 47 47 43 21 57 50 Cattle (Bos) 22 22 22 22 22 22 2 1 36 20 0 0 0 0 0 Primates (Prosimia) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Poultry (Poultry) 8,004 7,394 8,524 8,575 7,625 361 520 334 60 438 225 0 0 0 0 Other birds (pigeon) 0 11 3,000 150 150 0 0 270 22 265 Fish (Pisces) 20 10 100 522 180 245 146 25 270 813 120 137 326 0 0 Other animals 706 606 756 172 287 236 81 4 0 4 Protected animals* 68 53 65 59 45 305 268 227 270 146 26 39 145 3 1 Total 37,212 32,337 32,318 32,707 30,136 22,578 19,975 21,631 16,819 16,086 13,945 12,682 13,538 11,991 13,181 Legend to Table 1: * Protected or endangered animal species in accordance with the Decree (16, 17) applicable at the time 50 D. Ornik, V. Cadonic-Spelic Table 2: Number of animals used in experiments as to the purpose of use in the Republic of Slovenia in the period from 1992 to 2006 Research type 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 Baseline biological research (1) 13,107 12,711 14,526 13,863 13,656 2,668 4,276 4,001 2,688 3,688 3,975 3,700 4,391 1,888 1,457 Applied research (2) 23,282 18,701 16,649 16,018 15,545 17,974 14,048 13,018 12,071 10,081 8,685 8,202 8,182 9,420 10,564 Research of substances for protecting the public, animals and environment (3) 130 50 140 539 200 477 305 273 859 1,467 120 0 0 * * Education and practice (4) 177 85 87 182 112 832 812 745 475 468 336 239 454 283 214 Forensics (5) 4 11 2 1 0 0 0 0 0 0 0 0 0 0 0 Diagnosing diseases (6) 512 779 914 2,104 623 539 331 565 368 267 339 446 414 378 683 Other (7) 88 203 3,029 358 115 490 95 97 22 263 Total 37,212 32,337 32,318 32,707 30,136 22,578 19,975 21,631 16,819 16,086 13,945 12,682 13,538 11,991 13,181 (1) Baseline biological research: research of the anatomy or operation of living organisms, organs, tissues and cells (2) Applied research: research, development, quality control, pharmacological and toxicological analysing and testing of efficiency of medicinal products and medicinal substances in human medicine and dentistry, and in veterinary medicine. (3) Research of substances for protecting the public, animals and environment with toxicological and other testing (excluding medicinal products and medicinal substances) (4) Education and practice (5) Forensics: human or veterinary (6) Diagnosing diseases: tests for the specific determination of pathogens or for the production of diagnostic reagents (7) Other: other purposes of use of animals in experiments. * Number of animals used in the research of substances for protecting the public, animals and environment was in the period 2005 - 2006 included in the number of animals used in the applied research. Data on experimental animals used in the European Union in a 15-year period European Commission published five reports, which include data on experimental animals in the EU Member States. Table 3 shows the total number of animals used in experiments in the European Union in 1991, 1996, 1999, 2002 and 2005 (18, 19, 20, 21, 22). The first report on animals used in experiments in the EU Member States (18) includes data on the total number of animals in 1991 only, and was published in 1994. France and Portugal reported the data of 1992, and Belgium and Luxemburg did not present any relevant reports. Total number of experimental animals used in 1991, as reported by the EU Member States, amounted to 11.79 million. Data are shown in column 2 of Table 3. The second report on animals used in experiments in the EU Member States (19) provides data of 1996, and was published in 1999. The report includes the data of three new Member States, Austria, Finland and Sweden. France and Sweden presented their respective reports in the EU Tables, and the other Member States in the Convention Tables. France reported the data of 1997. This report and the subsequent reports include animals used for the education and training purposes. Such a purpose of use of animals is not laid down in Directive (2), but in Council Resolution 86/C331/02 (23). Some Member States included in their reports the animals which are neither indicated in the Directive nor in the Resolution, as for instance, the production of harmful mutants and transgenic animals. The number of animals used in experiments in the European Union in 1996 totalled 11.64 million. Table 4 shows relevant data. The second report includes also the data on the purpose of use of animals in experiments, as shown in Table 5. Thirteen Member States reported on the purposes of use of animals in experiments. In case of some Member States, the data on the total number of animals used in experiments did not tally with the data on the purpose of use of animals in experiments. Per purpose of use of animals in experiments, the number of animals used in experiments in 1996 in the thirteen Member States totalled 8.81 million. The third report on animals used in experiments in the EU Member States (20) provides the data of 1999, and was published in 2003. Member States presented their respective reports in the EU Tables, excluding one Member State that presented its re- Records on the use of animals in experiments in the Republic of Slovenia and in other EU member states... 51 Table 3: Total number of animals used for experimental purposes in the EU Member States in 1991, 1996, 1999, 2002 and 2005 Abbreviation Member State 1991 1996 1999 2002 2005 AT Austria 204,825 130,295 192,062 167,312 BE Belgium 1,515,867 790,089 695,091 718,976 CY Cyprus 967 C Z Czech Republic 330,933 DE Germany 2,402,710 1,509,619 1,591,394 2,071,568 1,822,424 DK Denmark 304,370 350,226 323,444 371,072 365,940 EL Greece 25,439 19,280 9,686 515,423 926,092 ES Spain 558,823 506,837 475,726 262,042 595,597 EE Estonia 4,900 FR France 3,645,708* 2,609,322** 2,309,597 2,212,294*** 2,325,398 HU Hungary 297,290 IE Ireland 25,199 77,107 73,929 52,203 37,940 IT Italy 683,293 1,094,185 987,771 924,889 896,966 LV Latvia 13,319 LT Lithuania 5,767 LU Luxembourg 1,003 3,060 5,320 4,120 MT Malta 0 NL The Netherlands 876,058 652,300 621,466 640,930 531,199 PL Poland 358,829 FT Portugal 87,117* 49,520 39,851 44,577 41,621 FI Finland 110,659 228,334 644,880 256,826 SI Slovenia 11,991 SK Slovakia 23,369 SE Sweden 286,012 324,067 281,184 505,681 UK United Kingdom 3,181,768 2,659,368 1,905,462 1,817,485 1,874,207 Total 11,790,485 11,646,130 9,814,171 10,731,020 12,117,583 * data of 1992 ** data of 1997 *** data of 2001 port in the Convention Tables. The number of animals used in experiments in the European Union in 1999 totalled 9.81 million. Table 6 shows relevant data. The third report made by 14 Member States included also the data on the purpose of use of animals in experiments, as shown in Table 7. Data on the total number of animals used in experiments do not tally with the number of animals per purpose of use of animals in experiments. The fourth report on animals used in experiments in the EU Member States (21), as shown in Table 8, provides the data of 2002, and was published in 2005. All the fifteen Member States presented their respective reports in the EU Tables, with the exception of France that reported the data of 2001. The number of animals used in experiments in the European Union in 2002 totalled 10.73 million. Part 2 of the report conveys the data of the particular Member States, including clarifications. Purposes of use of animals are described in detail, including the required conditions and types of testing. The fourth report includes the data on the purpose of use of animals in experiments, as shown in Table 9. All the Member States reported on the purposes of use of animals in experiments. Data on the total number of animals used in experiments do tally with the data on the purposes of use. 52 D. Ornik, V. Cadonic-Spelic Table 4: Total number of animals used for experimental purposes in 1996 in the EU Member States in 1996 Species AT BE DE DK EL ES FR* IE IT LU NL PT FI SE UK Total Rodents and rabbits 200,640 711,748 1,258,110 307,513 17,091 481,950 2,411,358 54,925 1,071,856 1,003 500,720 46,567 76,759 266,922 2,348,758 9,755,920 Cold - blooded vertebrates (1) 2,158 736,165 134,952 24,604 1,930 1,090 103,024 19,021 9,193 0 44,787 118 29,608 11,489 146,924 1,265,063 Birds (2) 0 54,982 94,793 9,347 129 17,736 67,652 94 9,218 0 86,071 329 1,912 3,178 113,691 459,132 Artio + Perissodactyla (3) 0 9,073 14,026 7,028 126 5,126 18,054 2,554 1,868 0 17,865 2,457 2,097 3,070 32,413 115,757 Carnivores(4) 274 2,899 5,887 1,710 2 812 6,545 513 1,254 0 1,763 44 248 1,266 12,980 36,197 Prosimians + Monkeys + apes 164 600 1,519 18 2 53 2,622 0 772 0 1,082 0 17 46 3,786 10,681 Other animals 1,589 400 332 6 0 70 67 0 24 0 12 5 18 41 816 3,380 Total 204,825 1,515,867 1,509,619 350,226 19,280 506,837 2,609,322 77,107 1,094,185 1,003 652,300 49,520 110,659 286,012 2,659,368 11,646,130 Species % AT BE DE DK EL ES FR* IE IT LU NL PT FI SE UK Mean Rodents and rabbits 97.96 46.95 83.34 87.80 88.65 95.09 92.41 71.23 97.96 100 76.76 94.04 69.37 93.33 88.32 83.77 Cold - blooded vertebrates (1) 1.05 48.56 8.94 7.03 10.01 0.22 3.95 24.67 0.84 0.00 6.87 0.24 26.76 4.02 5.52 10.86 Birds (2) 0.00 3.63 6.28 2.67 0.67 3.50 2.59 0.12 0.84 0.00 13.20 0.66 1.73 1.11 4.28 3.94 Artio + Perissodactyla (3) 0.00 0.60 0.93 2.01 0.65 1.01 0.69 3.31 0.17 0.00 2.74 4.96 1.90 1.07 1.22 0.99 Carnivores (4) 0.13 0.19 0.39 0.49 0.01 0.16 0.25 0.67 0.11 0.00 0.27 0.09 0.22 0.44 0.49 0.31 Prosimians + Monkeys + apes 0.08 0.04 0.10 0.01 0.01 0.01 0.10 0.00 0.07 0.00 0.17 0.00 0.02 0.02 0.14 0.09 Other animals 0.78 0.03 0.02 0.00 0.00 0.01 0.00 0.00 0.00 0.00 0.00 0.01 0.02 0.01 0.03 0.03 Total 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 * = France reporting for 1997 For abbreviations see Table 3 (1) = reptiles + amphibians + fish (2) = quails and other birds (3) = horses, donkeys and crossbreeds + pigs + goats and sheep + cattle (4) = cats + dogs + ferrets + other carnivores Table 5: Number of animals used for selected purposes versus species in the EU Member States in 1996 Species Baseline biological research Research, development and quality control of products and devices for human medicine and dentistry and for veterinary medicine Toxicological and other safety valuations (including valuation of products) Diagnosis of disease Education and training Other Total Rodents and rabbits 1,820,483 3,644,125 536,527 317,145 75,090 751,776 7,145,146 Cold - blooded vertebrates(1) 190,605 23,458 59,750 8,257 5,699 661,885 949,654 Birds (2) 64,592 68,256 6,226 5,406 936 45,423 190,839 Artio + Perissodactyla (3) 22,963 17,753 739 5,427 2,476 8,855 58,213 Carnivores (4) 8,381 14,982 3,403 814 693 211 28,484 Prosimians + Monkeys + apes 1,187 5,737 631 254 41 242 8,092 Other animals 98,561 129,136 152,167 51,064 7,019 1,337 439,284 Total 2,206,772 3,903,447 759,443 388,367 91,954 1,469,729 8,819,712 Records on the use of animals in experiments in the Republic of Slovenia and in other EU member states... 53 Table 6: Total number of animals used for experimental purposes in 1999 in the EU Member States Species AT BE DE DK EL ES FR IE IT LU NL PT FI SE UK Total Mice 91,194 446,677 775,932 163,680 3,566 261,301 1,552,330 31,251 410,788 3,000 277,774 23,669 89,959 184,230 990,162 5,305,513 Eats 12,699 169,662 403,227 96,864 1,900 134,070 460,407 14,484 500,625 20 159,768 9,836 32,519 84,374 526,904 2,607,349 Guinea - Pigs 7,367 37,397 42,891 10,431 240 13,892 77,021 1,041 18,474 20 10,246 1,452 1,737 9,355 61,308 292,872 Other Rodents 396 19,641 18,020 1,310 0 1,227 25,605 133 6,023 0 5,267 1,211 1,763 550 18,848 99,994 Rabbits 15,056 20,968 50,623 6,543 632 19,496 49,836 915 19,030 20 9,222 730 1,686 5,031 27,578 227,366 Cold - blooded vertebrates(1) 1,447 65,097 179,869 29,018 1,840 20,605 29,042 20,052 7,995 0 47,428 539 89,094 28,249 130,595 650,870 Birds (2) 1,367 19,726 92,792 5,225 80 19,027 86,610 1,229 20,157 0 92,823 267 5,228 6,920 105,931 457,382 Artio+ Perisso-dactyla (3) 670 8,874 17,765 9,004 1,426 4,181 18,735 4,370 3,295 0 17,430 1,752 2,347 4,165 29,376 123,390 Carnivores(4) 92 1,557 7,531 1,358 2 1,831 7,417 441 847 0 1,153 94 1,844 774 10,632 35,573 Prosimians+ Monkeys+apes 7 490 2,084 0 0 96 2,322 0 512 0 320 0 9 66 3,191 9,097 Other Mammals 0 0 660 11 0 272 13 25 0 45 301 2,148 353 937 4,765 Total 130,295 790,089 1,591,394 323,444 9,686 475,726 2,309,597 73,929 987,771 3,060 621,466 39,851 228,334 324,067 1,905,462 9,814,171 Species % AT BE DE DK EL ES FR IE IT LU NL PT FI SE UK Mean Mice 69.99 56.54 48.76 50.61 36.82 54.93 67.21 42.27 41.59 98.04 44.70 59.39 39.40 56.85 51.96 54.06 Rats 9.75 21.47 25.34 29.95 19.62 28.18 19.93 19.59 50.68 0.65 25.71 24.68 14.24 26.04 27.65 26.57 Guinea - pigs 5.65 4.73 2.70 3.22 2.48 2.92 3.33 1.41 1.87 0.65 1.65 3.64 0.76 2.89 3.22 2.98 Other rodents 0.30 2.49 1.13 0.41 0.00 0.26 1.11 0.18 0.61 0.00 0.85 3.04 0.77 0.17 0.99 1.02 Rabbits 11.56 2.65 3.18 2.02 6.52 4.10 2.16 1.24 1.93 0.65 1.48 1.83 0.74 1.55 1.45 2.32 Cold - blooded vertebrates(1) 1.11 8.24 11.30 8.97 19.00 4.33 1.26 27.12 0.81 0.00 7.63 1.35 39.02 8.72 6.85 6.63 Birds (2) 1.05 2.50 5.83 1.62 0.83 4.00 3.75 1.66 2.04 0.00 14.94 0.67 2.29 2.14 5.56 4.66 Artio +Perisso-dactyla (3) 0.51 1.12 1.12 2.78 14.72 0.88 0.81 5.91 0.33 0.00 2.80 4.40 1.03 1.29 1.54 1.26 Carnivores (4) 0.07 0.20 0.47 0.42 0.02 0.38 0.32 0.60 0.09 0.00 0.19 0.24 0.81 0.24 0.56 0.36 Prosimians+ Monkeys+apes 0.01 0.06 0.13 0.00 0.00 0.02 0.10 0.00 0.05 0.00 0.05 0.00 0.00 0.02 0.17 0.09 Other Mammals 0.00 0.00 0.04 0.00 0.00 0.00 0.01 0.02 0.00 0.00 0.01 0.76 0.94 0.11 0.05 0.05 Total 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 For abbreviations see Table 3 Table 7: Number of animals used for selected purposes versus species in the EU Member States in 1999 Species Baseline biological research Research, development and quality control of products and devices for human medicine and dentistry and for veterinary medicine Toxicological and other safety valuations (including safety valuation of products) Diagnosis of disease Education and training Other Total Mice 1,452,583 2,347,842 285,132 93,218 27,719 219,937 4,426,431 Rats 567,904 1,265,125 284,940 4,837 36,157 24,959 2,183,922 Other Rodents 40,631 215,796 51,397 3,618 1,571 11,897 324,910 Rabbits 22,701 84,159 30,104 9,108 3,316 9,850 159,238 Cold - blooded vertebrates (1) 215,412 56,186 82,113 21,317 11,300 82,470 468,798 Birds (2) 101,487 165,879 18,571 4,107 1,707 71,472 363,223 Artio + Perissodactyla (3) 45,687 34,135 3,584 3,573 4,824 13,129 104,932 Carnivores (4) 6,930 8,963 9,190 221 594 1,995 27,893 Prosimians + Monkeys + apes 1,279 1,796 3,687 22 4 206 6,994 Other Mammals 3,430 312 274 0 0 89 4,105 Total 2,458,044 4,180,193 768,992 140,021 87,192 436,004 8,070,446 54 D. Ornik, V. Cadonic-Spelic Table 8: Total number of animals used for experimental purposes in the EU Member States in 2002 Species AT BE DE DK EL ES FR* IE IT LU NL PT FI SE UK Total Mice 153,034 460,487 1,071,282 221,557 3,589 200,821 1,370,293 16,790 466,640 3,000 288,706 27,616 98,078 163,041 914,795 5,459,729 Rats 13,175 116,340 483,470 80,518 4,021 38,544 471,234 8,282 377,573 2,200 128,975 12,302 27,563 73,862 473,285 2,311,344 Guinea - Pigs 7,566 34,305 39,913 7,613 310 1,932 59,184 35 18,722 100 8,752 633 757 2,738 43,779 226,339 Other Rodents 132 19,315 24,057 6,966 135 587 24,099 6 9,106 0 7,788 93 3,822 1,283 13,820 111,209 Rabbits 15,560 10,805 132,833 5,542 1,492 2,292 53,545 130 12,481 20 8,093 908 1,235 2,165 20,574 267,675 Cold - blooded vertebrates (1) 1,176 26,235 208,805 36,171 502,360 14,888 109,831 21,046 6,202 0 32,426 2,399 502,400 19,383 165,938 1,649,260 Birds (2) 417 20,352 78,882 5,275 340 1,625 94,932 0 28,892 0 143,100 198 6,872 14,053 140,029 534,967 Artio + Perisso dactyla (3) 536 5,486 22,867 6,621 3,141 1,138 17,770 5,520 3,771 0 20,761 394 2,969 3,422 32,009 126,405 Carnivores (4) 388 1,191 6,468 794 35 141 7,518 262 1,071 0 1,968 34 494 1,049 8,699 30,112 Prosimians+ Monkeys+apes 78 567 1,844 5 0 74 3,840 0 420 0 270 0 0 91 3,173 10,362 Other Mammals 0 8 1,147 10 48 132 11 91 690 97 1,384 3,618 Total 192,062 695,091 2,071,568 371,072 515,423 262,042 2,212,294 52,203 924,889 5,320 640,930 44,577 644,880 281,184 1,817,485 1,0731,020 Species % AT BE DE DK EL ES FR* IE IT LU NL PT FI SE UK Mean Mice 79.68 66.25 51.71 59.71 0.70 76.64 61.94 32.16 50.45 56.39 45.04 61.95 15.21 57.98 50.33 50.88 Rats 6.86 16.74 23.34 21.70 0.78 14.71 21.30 15.86 40.82 41.35 20.12 27.60 4.27 26.27 26.04 21.54 Guinea - Pigs 3.94 4.94 1.93 2.05 0.06 0.74 2.68 0.07 2.02 1.88 1.37 1.42 0.12 0.97 2.41 2.11 Other Rodents 0.07 2.78 1.16 1.88 0.03 0.22 1.09 0.01 0.98 0.00 1.22 0.21 0.59 0.46 0.76 1.04 Rabbits 8.10 1.55 6.41 1.49 0.29 0.87 2.42 0.25 1.35 0.38 1.26 2.04 0.19 0.77 1.13 2.49 Cold - blooded vertebrates (1) 0.61 3.77 10.08 9.75 97.47 5.68 4.96 40.32 0.67 0.00 5.06 5.38 77.91 6.89 9.13 15.37 Birds (2) 0.22 2.93 3.81 1.42 0.07 0.62 4.29 0.00 3.12 0.00 22.33 0.44 1.07 5.00 7.70 4.99 Artio + Perisso dactyla (3) 0.28 0.79 1.10 1.78 0.61 0.43 0.80 10.57 0.41 0.00 3.24 0.88 0.46 1.22 1.76 1.18 Carnivores (4) 0.20 0.17 0.31 0.21 0.01 0.05 0.34 0.50 0.12 0.00 0.31 0.08 0.08 0.37 0.48 0.28 Prosimians + Monkeys +apes 0.04 0.08 0.09 0.00 0.00 0.03 0.17 0.00 0.05 0.00 0.04 0.00 0.00 0.03 0.17 0.10 Other Mammals 0.00 0.00 0.06 0.00 0.00 0.00 0.00 0.25 0.00 0.00 0.01 0.00 0.11 0.03 0.08 0.03 Total 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 * = France reporting for 2001 For abbreviations see Table 3 Table 9: Number of animals used for selected purposes versus species in the EU Member States in 2002 Species Baseline biological research Research, development and quality control of products and devices for human medicine and dentistry and for veterinary medicine Toxicological and other safety valuations (including safety valuation of products) Diagnosis of disease Education and training Other Total Mice 2,125,001 2,473,444 358,090 187,231 54,716 261,297 5,459,779 Rats 638,337 1,196,783 375,656 8,548 52,062 39,908 2,311,294 Other Rodents 47,140 201,372 69,792 2,931 2,435 13,878 337,548 Rabbits 19,621 178,776 45,067 8,232 2,095 13,884 267,675 Cold - blooded vertebrates(1) 690,261 472,495 175,220 2,486 218,566 90,232 1,649,260 Birds (2) 141,623 197,706 18,975 6,631 4,934 165,098 534,967 Artio + Perissodactyla (3) 56,065 37,871 3,227 10,528 6,741 11,973 126,405 Carnivores (4) 5,754 9,202 13,188 712 408 848 30,112 Prosimians + Monkeys + apes 1,738 1,580 6,832 34 7 171 10,362 Other Mammals 2,886 58 0 0 3 671 3,618 Total 3,728,426 4,769,287 1,066,047 227,333 341,967 597,960 1,0731,020 * = France reporting for 2004 Records on the use of animals in experiments in the Republic of Slovenia and in other EU member states... 55 The fifth report on animals used in experiments in the EU Member States (22) provides the data of 2005, and was published in 2007. All the twenty-five Member States presented their respective reports in the EU Tables. France presented its report of 2004. This report includes the data presented by the ten new EU Member States, i.e. Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia and Slovenia. The number of animals used in experiments in the European Union in 2005 totalled 12.11 million. Data by the old Member States are presented in Table 10, and data by the new Member States in Table 11. The number of animals used in the ten new Member States represents 8.6 % of the total number of animals used in the twenty-five Member States. Part 2 of the report conveys data presented by the particular Member States, including clarifications. Purposes of use of animals are described in detail, including the required conditions and types of testing. Data on the total number of animals used in experiments do tally with the data on the purposes of use. Table 12 shows relevant data. Table 10: Total number of animals used for experimental purposes in the 15 EU Member States reporting up to 2005 Species AT BE DE DK EL ES FR* IE IT LU NL PT FI SE UK Total Mice 128,634 488,125 1,084,358 208,375 15,340 393,217 1,510,334 17,776 534,614 3,280 240,048 28,318 120,636 213,727 1,052,064 6,038,846 Rats 11,920 106,483 435,417 85,664 6,024 125,754 424,387 7,722 279,774 720 116,608 6,793 28,358 83,321 411,501 2,130,446 Guinea - Pigs 3,149 39,530 37,761 5,046 574 16,780 79,350 4 11,533 100 7,479 379 563 2,014 28,918 233,180 Other Rodents 224 4,134 15,538 6,783 40 1,202 21,374 0 3,840 0 8,411 129 3,313 1,436 11,962 78,386 Rabbits 18,439 21,159 103,329 5,805 1,255 11,878 93,282 379 9,916 20 8,251 594 1,214 2,112 15,523 293,156 Cold - blooded vertebrates (1) 2,104 40,286 74,905 36,852 902,275 31,013 66,072 6,420 19,598 0 18,076 4,799 93,240 188,545 203,173 1,687,358 Birds (2) 1,025 13,691 41,607 7,784 21 8,425 106,263 2,024 31,697 0 111,233 112 5,773 7,838 115,000 452,493 Artio + Perissodactyla (3) 1,664 3,530 20,622 8,603 548 6,094 13,540 3,281 4,420 0 18,963 460 2,569 4,378 22,787 111,459 Carnivores (4) 97 1,530 6,686 843 14 1,090 7,007 286 1,094 0 1,790 36 188 1,596 7,623 29,880 Prosimians+ Monkeys+apes 56 449 2,086 0 1 84 3,789 0 412 0 327 0 0 75 3,115 10,394 Other Mammals 0 59 115 185 0 60 0 48 68 0 13 1 972 639 2,541 4,701 Total 167,312 718,976 1,822,424 365,940 926,092 595,597 2,325,398 37,940 896,966 4,120 531,199 41,621 256,826 505,681 1,874,207 1,1070,299 Species % AT BE DE DK EL ES FR IE IT LU NL PT FI SE UK Mean Mice 76.88 67.89 59.50 56.94 1.66 66.02 64.95 46.85 59.60 79.61 45.19 68.04 46.97 42.27 56.13 53.07 Rats 7.12 14.81 23.89 23.41 0.65 21.11 18.25 20.35 31.19 17.48 21.95 16.32 11.04 16.48 21.96 19.28 Guinea - Pigs 1.88 5.50 2.07 1.38 0.06 2.82 3.41 0.01 1.29 2.43 1.41 0.91 0.22 0.40 1.54 2.12 Other Rodents 0.13 0.57 0.85 1.85 0.00 0.20 0.92 0.00 0.43 0.00 1.58 0.31 1.29 0.28 0.64 0.79 Rabbits 11.02 2.94 5.67 1.59 0.14 1.99 4.01 1.00 1.11 0.49 1.55 1.43 0.47 0.42 0.83 2.58 Cold - blooded vertebrates (1) 1.26 5.60 4.11 10.07 97.43 5.21 2.84 16.92 2.18 0.00 3.40 11.53 36.30 37.29 10.84 15.07 Birds (2) 0.61 1.90 2.28 2.13 0.00 1.41 4.57 5.33 3.53 0.00 20.94 0.27 2.25 1.55 6.14 5.44 Artio + Perissodactyla (3) 0.99 0.49 1.13 2.35 0.06 1.02 0.58 8.65 0.49 0.00 3.57 1.11 1.00 0.87 1.22 1.16 Carnivores (4) 0.06 0.21 0.37 0.23 0.00 0.18 0.30 0.75 0.12 0.00 0.34 0.09 0.07 0.32 0.41 0.33 Prosimians + Monkeys + apes 0.03 0.06 0.11 0.00 0.00 0.01 0.16 0.00 0.05 0.00 0.06 0.00 0.00 0.01 0.17 0.09 Other Mammals 0.00 0.01 0.01 0.05 0.00 0.01 0.00 0.13 0.01 0.00 0.00 0.00 0.38 0.13 0.14 0.08 Total 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 * = France reporting for 2004 For abbreviations see Table 3 56 D. Ornik, V. Cadonic-Spelic Table 11: Total number of animals used for experimental purposes in the 10 New Member States in 2005 Species % CY CZ EE HU LV LT MT PL SI SK Total Mice 967 82,252 4,350 138,312 10,480 5,116 0 126,492 8,556 14,975 391,500 Rats 0 31,703 484 109,479 2,376 493 0 51,558 2,732 6,761 205,586 Guinea - Pigs 0 4,075 0 8,360 297 0 0 10,763 38 594 24,127 Other Rodents 0 6,018 0 518 0 0 0 11,069 18 0 17,623 Rabbits 0 5,567 66 9,152 166 158 0 3,101 533 782 19,525 Cold - blooded vertebrates(1) 0 71,186 0 11,315 0 0 0 56,413 3 0 138,917 Birds (2) 0 126,241 0 17,434 0 0 0 62,618 22 251 206,566 Artio + Perissodactyla (3) 0 3,193 0 1,303 0 0 0 24,026 74 0 28,596 Carnivores (4) 0 459 0 1,330 0 0 0 7,728 15 6 9,538 Prosimians + Monkeys + apes 0 51 0 6 0 0 0 0 0 0 57 Other Mammals 0 188 0 0 0 0 0 5,061 0 0 5,249 Total 967 330,933 4,900 297,209 13,319 5,767 0 358,829 11,991 23,369 1,047,284 Species % CY CZ EE HU LV LT MT PL SI SK Mean Mice 100 24.85 88.78 46.54 78.68 88.71 0 35.25 71.35 64.08 37.38 Rats 0.00 9.58 9.88 36.84 17.84 8.55 0 14.37 22.78 28.93 19.63 Guinea - Pigs 0.00 1.23 0.00 2.81 2.23 0.00 0 3.00 0.32 2.54 2.30 Other Rodents 0.00 1.82 0.00 0.17 0.00 0.00 0 3.08 0.15 0.00 1.68 Rabbits 0.00 1.68 1.35 3.08 1.25 2.74 0 0.86 4.45 3.35 1.86 Cold - blooded vertebrates (1) 0.00 21.51 0.00 3.81 0.00 0.00 0 15.72 0.03 0.00 13.26 Birds (2) 0.00 38.15 0.00 5.87 0.00 0.00 0 17.45 0.18 1.07 19.72 Artio + Perissodactyla (3) 0.00 0.96 0.00 0.44 0.00 0.00 0 6.70 0.62 0.00 2.73 Carnivores (4) 0.00 0.14 0.00 0.45 0.00 0.00 0 2.15 0.13 0.03 0.91 Prosimians + Monkeys + apes 0.00 0.02 0.00 0.00 0.00 0.00 0 0.00 0.00 0.00 0.01 Other Mammals 0.00 0.06 0.00 0.00 0.00 0.00 0 1.41 0.00 0.00 0.5 Total 100 100 100 100 100 100 0 100 100 100 100 Records on the use of animals in experiments in the Republic of Slovenia and in other EU member states... 57 Table 12: Number of animals used for selected purposes versus species in the all EU Member States* in 2005 Species Baseline biological research Research, development and quality control of products and devices for human medicine and dentistry and for veterinary medicine Toxicological and other safety valuations (including safety valuation ofproducts Diagnosis of disease Education and training Other Total Mice (Mus musculus) 2,465,474 2,727,254 384,741 225,524 86,597 551,356 6,440,946 Rats (Rattus norvegicus) 677,533 1,161,517 350,275 13,564 50,048 72,876 2,325,813 Other Rodents (other Rodentia) 53,241 230,403 56,006 4,512 2,606 6,548 353,316 Rabbits (Oryctolagus cuniculus) 15,463 237,411 38,761 8,322 3,856 8,829 312,642 Cold - blooded vertebrates(1 ) 485,858 942,973 116,123 5,905 40,236 235,180 1,826,275 Birds (Aves) (2) 251,443 249,024 53,935 9,723 5,440 89,494 659,059 Artio + Perissodactyla (3) 64,419 41,079 4,542 4,100 9,491 16,341 139,972 Carnivores (Carnivore) (4) 11,605 9,309 14,884 348 674 2,339 39,159 Prosimians + Monkeys + apes 1,456 1,397 7,004 16 42 536 10,451 Other Mammals (other Mammalia) 8,978 214 15 0 4 739 9,950 Total 4,035,470 5,600,581 1,026,286 272,014 198,994 984,238 12,117,583 * = France reporting for 2004 Table 13 shows the comparison between proportions of groups of animals used in the EU in experiments in 1996, 1999, 2002 and 2005 (22). As seen above, the most used group of animals represent the rodents and rabbits with around 80 %, with the highest use in 1999 and the lowest use in 2005. The second most used group of animals Discussion In the Republic of Slovenia, the data on animals used in experiments have been known since 1992; however, the data collection method was defined in 2004 only (in a specific regulation). Data collected in represent cold-blooded vertebrates, and their use ranges between 10 and 15 %, with the rather low use in 1999. Birds represent a third most used group of animals, which ranges between 4.7 and 5.4 %. A fourth most used group represent the equi-dae and ungulates with around 1 %. the Republic of Slovenia show a downward trend in animal use in experiments. In the beginning of data collection it was believed that the number of animals used in experiments would increase from year to year owing to the more comprehensive methods of data collection, though the real number of animals Table 13: Comparison between proportions of classes of animals used in EU in 1996, 1999, 2002 and 2005 Class of species 1996* 1999 2002** 2005*** % Rodents - rabbits (1) 81.3 86.9 78.0 77.5 % Cold - blooded vertebrates (2) 12.9 6.6 15.4 15 % Birds (3) 4.7 5 5.4 % Artio + Perissodactyla (4) 1.2 1.2 1.1 * = 14 Member States reporting for 1996; 1 for 1997 ** = 4 Member States reporting for 2002; 1 for 2001 *** = 24 Member States reporting for 2005; 1 for 2004 58 D. Ornik, V. Cadonic-Spelic used in experiments would be smaller. However, the presentation of the total number of animals used in experiments, by species and in a longer period of time, clearly demonstrates the opposite. In the Republic of Slovenia, the use of experimental animals in applied research shows a downward trend on account of validated alternative methods in use, which do not require animals, even if authorised for use in experiments by the law. In the most recent years in particular, the Slovenian legislative activity in the field of protection of experimental animals has been most productive with the scope of harmonising the Slovenian legislation with the EU law. Current activities are focused on improving the minimum accommodation standards and conditions of care of particular animal species, including those not covered by the applicable legislation. This is resulting from the Protocol of Amendment (ETS 170) to Convention (ETS 123) of the Council of Europe (23), which was fully transposed as recommendation by the European Commission (24) in Directive 86/609/EEC (2). A more extensive amendment of the applicable legislation is envisaged to take place, including the European Commission's proposal for a directive amending Directive 86/609/EEC. The proposed draft Directive (25) shall take into account the most recent developments in animal welfare and ethical concerns of animal use in experiments. The proposed draft Directive shall harmonise disparities between the national laws of the EU Member States so as to harmonise actions of protecting experimental animals, decreasing the number of animals used in experiments, and avoiding the unnecessary duplication of experiments. The Republic of Slovenia supports the strategy of protecting experimental animals, by urgently requiring the numbers of animals used in experiments to decrease, by introducing alternative methods and providing for the utmost protection and, at the same time, by providing for the welfare of animals which are still used in experiments on the reasonable and justifiable grounds. Reviewing the number of animals used in experiments in the particular EU Member States through all the five years of reporting, it may be established that the number of animals used in experiments has been oscillating in many Member States. Most animals were used in experiments in France, United Kingdom and in Germany. Data presented by the Member States show a general survey only of the use of animals in experiments in their respective countries. Data cannot be compared on account of the differing reporting methods. For this very reason it is important that the EU Member States present the data in a standardised way so as to facilitate comparison. It may be envisaged with certainty that the number of animals used in experiments will decrease in future, in the Republic of Slovenia as well as in the European Union. This fact will be influenced by the more rigorous legislation, more severe inspection and control, replacement of animals by alternative methods, authorisation granting procedures for the implementation of experiments which will take into account the opinions stated by the ethical commissions, staff qualification, higher responsibility of the researchers and their improved attitude towards experimental animals that shows in preparing the precise experimental protocols, in selecting the methods and in the implementation of experiments as such. In decreasing the numbers of experimental animals, the mutual cooperation of institutions, researchers at state and interstate levels, as well as active approach of animal protection societies will be of key importance. In decreasing the numbers of experimental animals in pharmaceutical industry in particular, in addition to the validated alternative methods, the interstate recognition of results obtained by experiments already conducted on animals, the improved biometric methods, improved baseline research stages of new substances, and the use of cell cultures, tissues or smaller groups of animals play a significant role. References 1. Council of Europe. European convention for the protection of vertebrate animals used for experimental and other scientific purposes. ETS No. 123. Strasbourg: Council of Europe, 1986: 51 str. 2. EEC. Council Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the member states regarding the protection of animals used for experimental and other scientific purposes. OJ EEC 1986; L 358 (29): 1-28. 3. EEC. Directive 2003/65/EC of the European Parliament and of the Council of 22 July 2003 amending Council Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the member states regarding the protection of animals used for experimental and other scientific purposes. OJ EEC 2003; L 230 (46): 32-3. 4. EEC. Council Decision of 23 March 1998 concerning the conclusion by the Community of the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes. OJ EEC 1999; L 222 (42): 29-30. Records on the use of animals in experiments in the Republic of Slovenia and in other EU member states... 59 5. Commission of the European Communities: establishment of a European Centre for the Validation of Alternative Methods (ECVAM). Communication from the Commission to the Council and the European Parliament. SEC (1991) 1794 final. Brussels: CEC, 1991: 6 str. 6. Commission of the European Communities. White paper: Strategy for a future chemicals policy. COM (2001) 88 final. Brussels: CEC, 2001: 1-32. 7. Commission of the European Communities. Commission working document on a Community action plan on the protection and welfare of animals 2006-2010. Strategic basis for the proposed actions. SEC (2006) 65. COM (2006) 14 final. Brussels: CEC, 2006: 1-25. 8. Animal Protection Act (ZZZiv-UPB2). UL RS 2007; 17 (43): 5943-56. 9. Rules on the professional, staffing and technical conditions for the carrying out of experiments on animals. UL RS 2004; 14 (36): 4330-2, corrigendum 14 (40): 4779-810. 10. Rules on conditions for experiments on animals. UL RS 2006; 16 (88): 9477-510. 11. Ornik D. Use of animals in experiments and of the system of control: doctoral thesis. Ljubljana: Veterinary Faculty, 1999: 141-2. 12. Ornik D, Pogacnik M, Lazar P, Skubic V, Tadic M. Use of animals in experiments in the Republic of Slovenia. Slov Vet Res 2000; 37 (1/2): 21-30. 13. Access to Public Information Act (official consolidated text). UL RS 2006; 16 (51): 5585-94. 14. EEC. Council Decision 2003/584/EC of 22 July 2003 concerning the conclusion of the Protocol of Amendment to the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes. OJ EEC 2003; L 198 (46): 10. 15. Act ratifying the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes (MEKZVU). UL RS-MP 2006; 16 (20): 1558-67. 16. Decree on the protection of endangered animal species. UL RS 1993; 3 (57): 2851-5, 2000; 10 (69): 8610. 17. Decree on protected wild animal species. UL RS 2004; 14 (46): 5963-6016; 14 (109): 12972; 2007; 17 (115): 16486-7. 18. Commission of the European Communities. First Commission report to the Council and to the European Parliament on statistics concerning the number of animals used for experimental purposes or for other scientific purposes COM (1994) 195 final. Brussels: CEC, 1994. 19. Commission of the European Communities. Second Commission report to the Council and to the European Parliament on statistics concerning the number of animals used for experimental purposes or for other scientific purposes in the Member States of the European Union COM (1999) 191 final. Brussels: CEC, 1999: 1-29. 20. Commission of the European Communities. Third Report from the Commission to the Council and the European Parliament on the Statistics on the number of animals used for experimental and other scientific purposes in the member states of the European Union COM (2003) 0019 final. Brussels: CEC, 2003: 1-175. 21. Commission of the European Communities. Fourth 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 (2005) 7 final. Brussels: CEC, 2005: 1-13. 22. Commission of the European Communities. Fifth report on the statistics on the number of animals used for experimental and other scientific purposes in the member states of the European Union. Part I. COM (2007) 675 final. Brussels: CEC, 2007: 1-61. 23. Council of Europe. Appendix A of the European convention for the protection of vertebrate animals used for experimental and other scientific purposes (ETS No. 123). Guidelines for accommodation and care of animals (article 5 of the convention). Strasbourg, 2006: 109p. 24. EEC. Commission Recommendation of 18 June 2007 on guidelines for the accommodation and care of animals used for experimental and other scientific purposes (notified under document number C (2007) 2525). OJ EEC 2007; L 197 (50): 1-89. 25. Commission of the European Communities. Proposal for a directive of the European parliament and of the Council on the protection of animals used for scientific purposes. COM, 2008 543/5. Brussels: CEC: 2008: 89str. 60 D. Ornik, V. Cadonic-Spelic POROČILA O UPORABI ŽIVALI V POSKUSIH V REPUBLIKI SLOVENIJI IN DRUGIH DRŽAVAH, ČLANICAH EVROPSKE UNIJE V 15-LETNEM OBDOBJU D. Ornik, V. Čadonič-Špelič Povzetek: Namen prispevka je prikazati podatke o številu in vrsti uporabljenih živali v poskusih ter o namenih uporabe živali v Republiki Sloveniji in Evropski uniji v obdobju 15 let. V Republiki Sloveniji na podlagi zbranih podatkov v letih od 1992 do 2006 ugotavljamo, da trend uporabe poskusnih živali pada. V letu 1992 jih je bilo 37.212, v letu 2006 pa le 13.181. V Sloveniji upada uporaba poskusnih živali zaradi uporabe validiranih alternativnih metod, ki ne zahtevajo živali. Zlasti v zadnjih nekaj letih poteka v Sloveniji aktivna zakonodajna dejavnost na področju zaščite poskusnih živali, da bi harmonizirali slovensko zakonodajo z evropsko. Evropska komisija je objavila pet poročil o uporabi živali v poskusih. Kot so poročale države članice, je bilo v letu 1991 11,79 milijona poskusnih živali, v letu 1996 11,64 milijona, v letu 1999 9,81 milijona, v letu 2002 10,73 milijona in v letu 2005 12,11 milijona. Prvi dve poročili dajeta nepopolno analizo zaradi neenotnega navajanja podatkov o uporabi poskusnih živali v državah članicah. Tretje in četrto poročilo temeljita na dogovorjenih enotnih tabelah. To omogoča razširjeno obrazložitev zbranih podatkov o uporabi poskusnih živali v Evropski uniji, kljub določenim neskladnostim pri poročanju držav članic. Drugo poročilo prvič vsebuje podatke, zbrane v treh novih državah članicah, peto poročilo pa v desetih novih državah članicah. Podatkov o uporabi živali v poskusne namene ni mogoče primerjati s tistimi iz prejšnjih poročil. Skupno število vključuje različne živalske vrste, od hladnokrvnih vretenčarjev na eni strani do sesalcev, kot so rejne živali ali človeku podobni primati v nekaterih državah članicah na drugi strani. Zaradi neenotnega poročanja držav članic primerjava med nacionalnimi poročili ni mogoča. Poročila dajejo le splošen pregled nad uporabo poskusnih živali na nivoju skupnosti. Ključne besede: poskusne živali; zakonodaja; poročilo