Legislation and guide

Animal Experimentation Legislation

The law sets out to protect animals used in current or future scientific experiments and teaching, by preventing them from being subjected to unjustified pain or suffering of any kind, by preventing any needless duplication of experimental procedures, and by keeping the number of animals used to a minimum. Its scope includes all non-human vertebrates, at all stages of development, except foetuses and embryos and non-experimental livestock-rearing and veterinary activity.
 
IN EUROPE
Ratification of the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes, Strasbourg, 18 March 1986 – Official State Gazette (BOE), 25 October 1990.
Protocol of Amendment, of 7 July 1998, to the European Convention for the Protection of Vertebrate Animals used for Experimental and Scientific Purposes.
Recommendation of the Commission, of 18 June 2007, on guidelines for the accommodation and care of animals used for experiments and other scientific purposes.
Directive 2010/63/EU, of 22 September 2010, on the protection of animals used for scientific purposes. 

Reglamento (UE) 2019/6 del Parlamento Europeo y del Consejo de 11 de diciembre de 2018 sobre medicamentos veterinarios y por el que se deroga la Directiva 2001/82/CE

IN SPAIN
Royal Decree 53/2013, of 1 February, which sets out the basic rules to protect animals used in experiments and for other scientific purposes, including teaching.

Royal Decree 118/2021, of 23 February, which modifies Royal Decree 53/2013, of February 1, which establishes the basic rules applicable for the protection of animals used in experimentation and other scientific purposes , including teaching.
Law 32/2007, of 7 November, on the care of animals, with regard to their exploitation, transport, experimentation and slaughter.
Law 6/2013, of 11 June, modifying Law 32/2007, of 7 November, on the care of animals, with regard to their exploitation, transport, experimentation and slaughter.
Order ECC/566/2015, of 20 March, establishing the qualifications required of personnel who handle animals used, bred or supplied for experiments or for other scientific purposes, including teaching.
Royal Decree 1386/2018, of November 19, which modifies Royal Decree 53/2013, of February 1, which establishes the basic rules applicable for the protection of animals used in experimentation and other scientific purposes , including teaching.

Other regulations on animal protection

Royal Decree 1551/2011, of 31 October, to complement the National Catalogue of Professional Qualifications by establishing five professional qualifications within the Agricultural professional family, including: a) care of animals used for research and other scientific purposes; b) performing experimental procedures with animals for research and other scientific purposes.
Royal Decree 983/2013, of 13 December, to establish four professionalism certificates in the Agricultural professional family, included in the National Listing of Professionalism Certificates

CATALONIA

• Commission Implementing Decision, of 20 December 2013, which corrects Annexe 2 of Implementing Decision 2012/707/EU, and establishes 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  ( L 10/18 published 15/01/2014 )
• 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 (L 320/33 published 17/11/2012)
• Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes(L 276/33, published 20/10/2010 )
• Correction of errors in Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes.(L 28/49, published 04/02/2015 )
• Law 6/2013, of 11 June, modifying Law 32/2007, of 7 November, on the care of animals, with regard to their exploitation, transport, experimentation and slaughter.(140 no. Law or Legislative Decree published 12/06/2013)
• Law 32/2007, of 7 November, on the care of animals, with regard to their exploitation, transport, experimentation and slaughter.(268 no. Law or Legislative Decree published 08/11/2007)
• Royal Decree 53/2013, of 1 February, which sets out the basic rules to protect animals used in experiments and for other scientific purposes, including teaching.(34 no. Royal Decree published 08/02/2013)
• Law 5/1995, of 21 de junio, to protect animals used in experiments and for other scientific purposes.(2073 no. DOGC published 10/07/1995)
• Decree 214/1997, of 30 July, regulating the use of animals in experiments and for other scientific purposes. (2450 no. DOGC published 07/08/1997)
• Decree 164/1998, of 8 July, modifying Decree 214/1997, of 30 July, regulating the use of animals in experiments and for other scientific purposes.(2680 no. Decree published 14/07/1998)
• Decree 286/1997, of 31 July, modifying Decree 214/1997, of 30 July, regulating the use of animals in experiments and for other scientific purposes.(2518 no. Decree published 14/11/1997)

LINKS OF INTEREST
Bienestar Animal Welfare
Departament d’Agricultura, Ramaderia, Pesca i Alimentació. Benestar Animal
Spanish Ministry of Agriculture, Food and Environment. Bienestar Animal
Centre d'Educació en Benestar d'Animals de Producció (FAWEC)
http://www.ahwla.org.uk/
http://www.uab.cat/web/bioseguretat/avaluacio-de-procediments-experimentals-1274943304601.html
http://www.isogenic.info/html/design.html
http://ec.europa.eu/environment/chemicals/lab_animals/
http://www.nc3rs.org.uk/resource-hubs
http://eara.eu/es/
http://journals.sagepub.com/doi/full/10.1177/0023677217724823
https://www.edqm.eu/sites/default/files/pr_pheur159sess_abnormal_toxicity_2017.pdf
https://www.ltk.uzh.ch/en/Breeding.html / https://www.nature.com/articles/s41684-023-01213-1#MOESM1
Calculation according to the Mendelian frequency, the Festing or Poisson method

INSTITUTIONAL
http://www.cosce.org/
http://www.ub.edu/rceue/

SEVERITY
http://ec.europa.eu/environment/chemicals/lab_animals/pdf/guidance/severity/es.pdf

ALTERNATIVE METHODS
http://www.remanet.net/
http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm
https://www.edqm.eu/en/european-pharmacopoeia-8th-edition-1563.html
https://ec.europa.eu/jrc/en/science-update/reduction-animal-tests-veterinary-vaccines-new-guidelines