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Directive 2010/63/EU

January 01, 1970

Directive 2010/63/EU[1] is the European Union (EU) legislation "on the protection of animals used for scientific purposes" and is one of the most stringent ethical and welfare standards worldwide.[2]

Directive 2010/63/EU is the European Union legislation that protects animals being used in research.

The Directive repealed Directive 86/609/EEC. It became formally applied across the EU on 1 January 2013. It protects live non-human vertebrates including independently feeding larval forms and foetal forms of mammals from the last third of their normal development, and live cephalopods.

History edit

The Directive is based on the Council of Europe's European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes (ETS123) established in 1986. The EU is a party to this convention as are several EU and non-EU members.[3]

The Directive repealed Directive 86/609/EEC. It took nearly two years to revise, beginning in November 2008. It was finalised and signed on 22 September 2010, coming into force on 9 November 2010. Member States were then allowed one year to transpose it into their own words before it became formally applied across the EU on 1 January 2013.[3][4]

The ultimate aim of the Directive is to replace animals in research.[5]

Scope edit

Because it is a Directive, it allows Member States certain flexibility in transposition of national rules. The status of the implementation of the new Directive in the EU is described by the EC General Environment Directorate.[6] Purposes of this Directive are to provide scope (via Articles 1 & 3), harmonise the current EU understanding of what defines an animal (Article 1.3), map resources, identify competent people and authorities (Articles 47.5 & 48), establish a common framework, and promote collaboration of the Member States with the EC to promote animal welfare in the EU as a European value in Article 13 of the Treaty of the Functioning of the EU (TFEU).

Animal welfare is not an EU policy area per se as for example agriculture, fisheries and research, but rather that "In formulating and implementing the Union's agriculture, fisheries, transport, internal markets, research, technological development, and space policies, the Union and the Member States shall, since animals are sentient beings, pay full regard to the welfare of animals, while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage". As with most EU legislation when animal welfare is not respected; one must refer a complaint directly to the Member State. Promotion and use of alternative animal testing methods and 3Rs are written elsewhere within EU legislation (e.g. REACH, Cosmetics, PPP, Biocides ...). EU agencies (ECHA, EMA, EFSA) also contribute to the protection of laboratory animals used for scientific purposes.

 
The Directive now protects cephalopods such as this Caribbean reef squid (Sepioteuthis sepioidea).
Article 1.3: The new EU Directive applies to the following animals: (a) live non-human vertebrate animals, including: (i) independently feeding larval forms; and (ii) foetal forms of mammals from the last third of their normal development; (b) live cephalopods.
Article 4: The Directive refers directly to the Three Rs (3Rs): "Principle of replacement, reduction and refinement" first described by Russell and Burch in 1959.[7]
Article 47-2: Member States shall assist the Commission in identifying and nominating suitable specialised and qualified laboratories to carry out such validation studies.

Laboratories for the Validation of Alternative Methods edit

In July 2013, the Commission announced the creation of European Union Network of Laboratories for the Validation of Alternative Methods [1] (EU-NETVAL)[8] EU-NETVAL's primary role is to provide support for the European Union Reference Laboratory for Alternatives to Animal Testing [2] (EURL ECVAM) validation projects, including aspects of training and dissemination, and the identification of methods that have a potential to reduce, refine or replace animals used for scientific purposes.[9] Any EU laboratory is allowed to apply as long as they follow the eligibility criteria listed by the EC, such as sufficient scientific staff, adequate equipment and GLP/or ISO certificates.[10] As of March 2016, there are 38 test facilities: Belgium (3) Czech Republic (1), European Commission (1), Finland (1), France (3), (Germany) (6), Hungary (1), Italy (8), the Netherlands (2), Poland (2), Slovakia (1), Spain (3), Sweden (1), Switzerland (2) and the United Kingdom (2).[11]

References edit

  1. ^ "Directive 2010/63/EU of the European Parliament and of the Council". Official Journal of the European Union. Retrieved 16 August 2020.
  2. ^ . EuroScience. 2015. Archived from the original on 10 April 2021. Retrieved 18 May 2016.
  3. ^ a b "European Directive". Understanding Animal Research. Retrieved 18 May 2016.
  4. ^ "EURLex – 31986L0609 – EN – EUR-Lex". Eur Lex. 11 April 2014. Retrieved 24 April 2014.
  5. ^ Hartung, T. (2010). "Comparative analysis of the revised directive 2010/63/EU for the protection of laboratory animals with its predecessor 86/609/EEC–a t4 report". Altex. 27 (4): 285–303. doi:10.14573/altex.2010.4.285. PMID 21240470.
  6. ^ "Animals used for scientific purposes – Environment". European Commission. 11 April 2014. Retrieved 24 April 2014.
  7. ^ Russell, W.M.S.; Burch, R.L. (1959). The Principles of Humane Experimental Technique. Methuen, London. ISBN 0-900767-78-2.
  8. ^ "EURL ECVAM's" (PDF). European Commission. Retrieved 26 February 2014.
  9. ^ "EUNETVAL (European Union Network of Laboratories for the Validation of Alternative Methods) – Institute for Health and Consumer Protection – (JRC-IHCP), European Commission". European Commission. 20 January 2014. Retrieved 27 January 2014.
  10. ^ "EURL ECVAM's" (PDF). European Commission. Retrieved 26 February 2014.
  11. ^ "European Union network of laboratories for the validation of alternative methods". European Commission. 2016. Retrieved 19 May 2016.

January 01, 1970
directive, 2010, european, union, legislation, protection, animals, used, scientific, purposes, most, stringent, ethical, welfare, standards, worldwide, european, union, legislation, that, protects, animals, being, used, research, directive, repealed, directiv. Directive 2010 63 EU 1 is the European Union EU legislation on the protection of animals used for scientific purposes and is one of the most stringent ethical and welfare standards worldwide 2 Directive 2010 63 EU is the European Union legislation that protects animals being used in research The Directive repealed Directive 86 609 EEC It became formally applied across the EU on 1 January 2013 It protects live non human vertebrates including independently feeding larval forms and foetal forms of mammals from the last third of their normal development and live cephalopods Contents 1 History 2 Scope 3 Laboratories for the Validation of Alternative Methods 4 ReferencesHistory editThe Directive is based on the Council of Europe s European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes ETS123 established in 1986 The EU is a party to this convention as are several EU and non EU members 3 The Directive repealed Directive 86 609 EEC It took nearly two years to revise beginning in November 2008 It was finalised and signed on 22 September 2010 coming into force on 9 November 2010 Member States were then allowed one year to transpose it into their own words before it became formally applied across the EU on 1 January 2013 3 4 The ultimate aim of the Directive is to replace animals in research 5 Scope editBecause it is a Directive it allows Member States certain flexibility in transposition of national rules The status of the implementation of the new Directive in the EU is described by the EC General Environment Directorate 6 Purposes of this Directive are to provide scope via Articles 1 amp 3 harmonise the current EU understanding of what defines an animal Article 1 3 map resources identify competent people and authorities Articles 47 5 amp 48 establish a common framework and promote collaboration of the Member States with the EC to promote animal welfare in the EU as a European value in Article 13 of the Treaty of the Functioning of the EU TFEU Animal welfare is not an EU policy area per se as for example agriculture fisheries and research but rather that In formulating and implementing the Union s agriculture fisheries transport internal markets research technological development and space policies the Union and the Member States shall since animals are sentient beings pay full regard to the welfare of animals while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites cultural traditions and regional heritage As with most EU legislation when animal welfare is not respected one must refer a complaint directly to the Member State Promotion and use of alternative animal testing methods and 3Rs are written elsewhere within EU legislation e g REACH Cosmetics PPP Biocides EU agencies ECHA EMA EFSA also contribute to the protection of laboratory animals used for scientific purposes nbsp The Directive now protects cephalopods such as this Caribbean reef squid Sepioteuthis sepioidea Article 1 3 The new EU Directive applies to the following animals a live non human vertebrate animals including i independently feeding larval forms and ii foetal forms of mammals from the last third of their normal development b live cephalopods Article 4 The Directive refers directly to the Three Rs 3Rs Principle of replacement reduction and refinement first described by Russell and Burch in 1959 7 Article 47 2 Member States shall assist the Commission in identifying and nominating suitable specialised and qualified laboratories to carry out such validation studies Laboratories for the Validation of Alternative Methods editIn July 2013 the Commission announced the creation of European Union Network of Laboratories for the Validation of Alternative Methods 1 EU NETVAL 8 EU NETVAL s primary role is to provide support for the European Union Reference Laboratory for Alternatives to Animal Testing 2 EURL ECVAM validation projects including aspects of training and dissemination and the identification of methods that have a potential to reduce refine or replace animals used for scientific purposes 9 Any EU laboratory is allowed to apply as long as they follow the eligibility criteria listed by the EC such as sufficient scientific staff adequate equipment and GLP or ISO certificates 10 As of March 2016 there are 38 test facilities Belgium 3 Czech Republic 1 European Commission 1 Finland 1 France 3 Germany 6 Hungary 1 Italy 8 the Netherlands 2 Poland 2 Slovakia 1 Spain 3 Sweden 1 Switzerland 2 and the United Kingdom 2 11 References edit Directive 2010 63 EU of the European Parliament and of the Council Official Journal of the European Union Retrieved 16 August 2020 EuroScience supports Directive 2010 63 EU on the protection of animals used for scientific purposes EuroScience 2015 Archived from the original on 10 April 2021 Retrieved 18 May 2016 a b European Directive Understanding Animal Research Retrieved 18 May 2016 EURLex 31986L0609 EN EUR Lex Eur Lex 11 April 2014 Retrieved 24 April 2014 Hartung T 2010 Comparative analysis of the revised directive 2010 63 EU for the protection of laboratory animals with its predecessor 86 609 EEC a t4 report Altex 27 4 285 303 doi 10 14573 altex 2010 4 285 PMID 21240470 Animals used for scientific purposes Environment European Commission 11 April 2014 Retrieved 24 April 2014 Russell W M S Burch R L 1959 The Principles of Humane Experimental Technique Methuen London ISBN 0 900767 78 2 EURL ECVAM s PDF European Commission Retrieved 26 February 2014 EUNETVAL European Union Network of Laboratories for the Validation of Alternative Methods Institute for Health and Consumer Protection JRC IHCP European Commission European Commission 20 January 2014 Retrieved 27 January 2014 EURL ECVAM s PDF European Commission Retrieved 26 February 2014 European Union network of laboratories for the validation of alternative methods European Commission 2016 Retrieved 19 May 2016 Retrieved from https en wikipedia org w index php title Directive 2010 63 EU amp oldid 1202623841, wikipedia, wiki, book, books, library,

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