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KERD
논문KCI 등재

선진 외국의 동물대체시험법 개발현황과 전망

Current Status of Alternatives to Animal Experiments in Advanced Foreign Countries

김주환|이은호|김명주|김형건|이진구|민영실|김학림
한국동물실험대체법학회 (Korean Society for Alternatives to Animal Experiments)|2016.11|한국동물실험대체법학회지 (Journal of Alternatives to Animal Experiments)|제10권 제1호|pp. 1-16|DOI 10.23032/jaae.2016.10.1.002

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Abstract

The recognition of welfare for experimental animal based on 3Rs principles has been spreading throughout the developed countries and therefore, on the demand of alternatives to animal experiments have been continually increased, especially in advanced countries. Recently, EU prohibited animal uses for developing cosmetic products at any level and some other countries applied already or are trying to setting the similar level of limitation of animal uses for cosmetic industries. According to the global trends, the marketing ban for animal used cosmetics will be applied soon in Korea. In this study, we summarize the polices, regulations, research developments, and validation processes of the animal alternatives methods of foreign countries and use those as a basal information for improving the alternatives regulation and developments. This research project was mainly focused to summarize and analyze related topics including, 1) Investigation of current policies of alternatives in EU, Japan, and USA etc. 2) Investigation of current regulatory trends of alternatives in foreign countries. 3) Investigation of current research trends of alternatives in foreign countries 4) Investigation of current validation processes of alternatives in foreign countries. Investigating the latest data on the status of animal alternatives methods and based on those, someone could use our study for setting the important research theme, roadmap for long-term development strategy of animal alternatives. However, due to the dynamic update trends in the alternative methods in many countries, the newly updated documents could be released at any time.

참고문헌 (56)

  1. 우병준, "EU 동물복지정책 동향", 세계농업, (163), pp.47~62 (2014)
  2. Andersen ME, "The future of toxicity testing", Journal of Toxicology and Environmental Health, Part B, Critical Reviews, 13(2-4), pp.163~196 (2010)
  3. Araújo GLD, "Alternative methods in toxicity testing: the current approach", Brazilian Journal of Pharmaceutical Sciences, 50(1), pp.55~62 (2014)
  4. Attene-Ramos MS, "The Tox21 robotic platform for the assessment of environmental chemicals-from vision to reality", Drug Discov Today, 18(15-16), pp.716~723 (2013)
  5. The AXLR8 Project: Final Report & Recommendations, "AXLR8", AXLR8 Consortium, 1~19 (2013)
  6. Bergman RK, "New test for endotoxin potency based upon histamine sensitization in mice", Infection Immunity, 18(2), pp.352~355 (1977)
  7. Bouhifd M, "Automation of an in vitro cytotoxicity assay used to estimate starting doses in acute oral systemic toxicity tests", Food and Chemical Toxicology, 50(6), pp.2084~2096 (2012)
  8. Commission of European Communities, "Council Regulation (EC) No 440", 2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907, Official Journal of the European Union, pp.2008 (2006), L142[DOI]
  9. Committee on Toxicity Testing and Assessment of Environmental Agents, National Research Council, "Toxicity Testing in the 21st Century: A Vision and a Strategy" (2007), National Academy of Sciences
  10. "Coordination of projects on new approaches to replace current repeated dose systemic toxicity testing of cosmetics and chemicals’ (COACH) SEURAT-1. Towards the Replacement of in vivo repeated Dose Systemic Toxicity Testing. Volume 4", COACH consortium, 1~396 (2014)
  11. "European Treaty Series - No. 123 : European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes" (1986)[URL]
  12. Council of Europe, "European Treaty Series - No. 123, European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes", ~ (1986)
  13. Council of Europe, "European Treaty Series - No. 170, Protocol of amendment to the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes", ~ (1998)
  14. Council of European Communities, "COUNCIL DIRECTIVE 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 purposes (86", 609, Official Journal of the European Union, pp.1986, L358[DOI]
  15. Dix DJ, "The ToxCast program for prioritizing toxicity testing of environmental chemicals", Toxicological Sciences, 95(1), pp.5~12 (2007)
  16. Eskes C, "Proposal for a Brazilian centre on alternative test methods", Altex, 26(4), pp.303~306 (2009)
  17. Eskes C, Whelan M, "Validation of Alternative Methods for Toxicity Testing, Advances in experimental medicine and biology, (ISSN 2214-8019, 856)", ~ (2016)
  18. "European Union Reference Laboratory for Alternatives to Animal Testing" (2016)[URL]
  19. "EUROECOTOX NEWSLETTER" (2014)[URL]
  20. European Commission, "Regulation No 1107", 2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79, EEC and 91, pp.414, EEC[DOI]
  21. European Commission, "Regulation (EC) No 1907", 2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 2006, pp.L396, 1~849
  22. European Commission, "Regulation (EC) No 1272", 2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67, EEC and 1999, pp.45, EC, and amending Regulation (EC) No 1907[DOI]
  23. European Commission, "Regulation No 1223", 2009 of the European Parliament and the Council of 30 November 2009 on cosmetic products, 2009, pp.L342, 59~209
  24. European Commission, "Directive 2010", 63, Official Journal of the European Union, pp.2010, L276[DOI]
  25. European Commission, "Regulation (EU) No 528", 2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, 2012, pp.L167, 1~116
  26. European Union, "CONSOLIDATED VERSION OF THE TREATY ON THE FUNCTIONING OF THE EUROPEAN UNION", Official Journal of the European Union, 326(47), pp.1~154 (2012)
  27. European Union, "CONSOLIDATED VERSION OF THE TREATY ON THE FUNCTIONING OF THE EUROPEAN UNION (TFEU)", Official Journal of the European Communities, C326, pp.47~390 (2012)
  29. Filipecki ATP, "The Brazilian legal framework on the scientific use of animals", ILAR Journal, 52(1), pp.E8~E15 (2011)
  30. Food Policy Evaluation Consortium (FPEC), "Final Report: Evaluation of the EU Policy on Animal Welfare and Possible Policy Options for the Future", Food Policy Evaluation Consortium J7296, 1~19 (2010)
  31. Isbrucker R, "Report on the international workshop on alternatives to the murine histamine sensitization test (HIST) for acellular pertussis vaccines: state of the science and the path forward", Biologicals, 42(2), pp.114~122 (2014)
  32. Judson RS, "In vitro screening of environmental chemicals for targeted testing prioritization : the ToxCast project", Environmental Health Perspectives, 118(4), pp.485~492 (2010)
  33. Judson RS, "Estimating toxicity-related biological pathway altering doses for high-throughput chemical risk assessment", Chemical Research Toxicology, 24(4), pp.451~462 (2011)
  34. Judson R, "In vitro and modelling approaches to risk assessment from the U.S. Environmental Protection Agency ToxCast programme", Basic & Clinical Pharmacology & Toxicology, 115(1), pp.69~76 (2014)
  35. Katsarova I, "Animal welfare protection in the EU, Library Briefing", Library of the European Parliament, 1~6 (2013)
  36. Kavlock R, "Update on EPA’s ToxCast program: providing high throughput decision support tools for chemical risk management", Chemical Research Toxicology, 25(7), pp.1287~1302 (2012)
  37. Kojima H., "JaCVAM: An organization supporting the validation and peer review of new alternatives to animal testing", AATEX, 14(Spec), pp.483~485 (2007)
  38. Kojima H., "Update from the Japanese Center for the Validation of Alternative Methods (JaCVAM)", ATLA, 41, pp.435~441 (2013)
  39. Laquieze L, "Alternative Methods to Animal Testing and Cosmetic Safety: An Update on Regulations and Ethical Considerations in Brazil", Applied In Vitro Toxicology, 1(4), pp.243~253 (2015)
  40. Louhimies S, "Directive 86", 609, ATLA, pp.2002, 30(Supp.2)[DOI]
  41. Martin MT, "Predictive model of rat reproductive toxicity from ToxCast high throughput screening", Biology of Reproduction, 85(2), pp.327~339 (2011)
  42. Ohno Y., "Significance of Japanese Center for the validation of alternative methods (JaCVAM) Establishment", AATEX, 11(1), pp.1~3 (2005)
  43. Rief DM, "Endocrine profiling and prioritization of environmental chemicals using ToxCast data", Environmental Health Perspectives, 118(12), pp.1714~1720 (2010)
  44. "Regulation (EC) No 1907/2006., The consolidated version of the Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) incorporates all of the amendments and corrigenda to REACH until the date marked in the first page of the regulation"[URL]
  45. Russell W, "The Principles of Humane Experimental Technique" (1959), Methu
  46. Seligmann Jr EB, "Laboratory techniques in rabies: the NIH test for potency", Monograph series. World Health Organization, (23), pp.279~286 (1973)
  47. Shah I, "Using nuclear receptor activity to stratify hepatocarcinogens", PLoS One, 6(2), pp.e14584~ (2011)
  48. Stokes W, "Report on the international workshop on alternative methods for human and veterinary rabies vaccine testing : state of the science and planning the way forward", Biologicals, 40(5), pp.369~381 (2012)
  49. Stokes W, "Report on the international workshop on alternative methods for Leptospira vaccine potency testing: state of the science and the way forward", Biologicals, 41(5), pp.279~294 (2013)
  50. "1999/575/EC: 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, Official Journal of the European Union L222:29–30" (1999)[URL]
  51. The Council of European Union, "2003", 584, Official Journal of the European Union, pp.2003, L198[DOI]
  52. "2012/707/EU: Commission Implementing Decision of 14 November 2012 establishing a common format for the submission of the information pursuant to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes" (2012)[URL]
  53. "2014/11/EU: Commission Implementing Decision of 20 December 2013 correcting Annex II to Implementing Decision 2012/707/EU establishing a common format for the submission of the information pursuant to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes (notified under document C(2013) 9220) Text with EEA relevance Official Journal of the European Union"[URL]
  54. Vapnek J, "Legislative and regulatory options for animal welfare", FAO LEGISLATIVE STUDY 104, FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS (FAO), ~ (2011)
  55. Zhengming H, "Alternative methods for animal tests in the quality control of biological products in China", AATEX, 14(Spec), pp.591~593 (2008)
  56. Zhengming H, "Future Perspectives for Alternatives to Animal Testing in China", the 9th World Congress on Alternatives and Animal Use in the Life Sciences (2014)

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