Guidance

Animal testing and research

Guidance on how to carry out scientific research and testing using animals, and how to apply for licences.

Animals (Scientific Procedures) Act 1986

The use of animals in experiments and testing is regulated under the Animals (Scientific Procedures) Act 1986 (ASPA). ASPA has recently been revised to change the European Directive 2010/63/EU on the protection of animals used for scientific purposes. The revised legislation came into force on 1 January 2013.

ASPA is implemented by the Home Office in England, Scotland and Wales and by the Department for Health, Social Security and Public Safety in Northern Ireland.

You can read EU guidance, statistics and publications relating to animals used for scientific purposes under the European Directive 2010/63/EU.

Animals in Science Regulation Unit (ASRU) Guidance

You can read ASRU guidance that explains how the Act is administered and enforced including detailed advice for licence holders

Compliance with ASPA

You can read how potential incidences of non-compliance with ASPA are identified and dealt with and anonymised reports of substantial investigations.

Replacement, Reduction and Refinement

The government is committed to the replacement, reduction, and refinement of the use of animals in research - the ‘3Rs’.

The use of animals in scientific research remains a vital tool in improving our understanding of how biological systems work both in health and disease, and in the development of new medicines, treatments and technologies. Underpinning this research is a strong commitment to maintaining a rigorous regulatory system which ensures that animal research is carried out only where no practicable alternative exists and under controls which keep suffering to a minimum. This is achieved through robustly applying the principles of the 3Rs to all research proposals involving the use of animals.

Implementing the 3Rs requires that, in every research proposal, animals are replaced with non-animal alternatives wherever possible; that the number of animals is reduced to the minimum needed to achieve the results sought; and that, for those animals which must be used, procedures are refined as much as possible to minimise their suffering. The government is committed to ensuring that any licence we grant under the Animals (Scientific Procedures) Act 1986 must rigorously and demonstrably apply the 3Rs principles.

In 2010, the coalition government made a commitment to work to reduce the use of animals in scientific research and a delivery plan has been published. The plan shows how alternative methods can deliver fast, high-quality research that also boosts economic growth. We have now published a delivery report which describes the progress made on actions set out in the delivery plan.

Applying for licences

Three licences are required by the ASPA before testing on animals is permitted:

  • personal licence for each person carrying out procedures on animals
  • project licence for the programme of work
  • establishment licence for the place at which the work is carried out

Read the guidance on applying for a licence to carry out animal testing.

Project Licence Standard Condition 18 notification

All project licences are subject to a set of standard conditions. Standard Condition 18 requires that the project licence holder (PPLh) notifies the Secretary of State as soon as possible if constraints on the severity limits, or observance of other controls described in the licence, have been breached or are likely to have been breached. You can read our Advice note - Project Licence Standard Condition 18 Notification (PDF, 368KB, 22 pages) , and our proforma Project Licence Standard Condition 18 Notification form (MS Word Document, 46.3KB) for making reports.

Statistics

The full report of the 2017 statistics on scientific procedures on living animals was published on 19 July 2018.

You can also view previous reports in the Statistics of scientific procedures on living animals collection.   

Annual returns

Statistics are collected annually in the United Kingdom to meet the requirements of the Animals (Scientific Procedures) Act 1986 to collect and publish statistical information on the use of protected animals in regulated procedures.

If you are a project licence holder please read our guidance on the annual returns process

Non-technical summaries

Publication of non-technical summaries is a legal requirement under Article 43 of EU Directive 2010/63. This mandatory requirement will help put the debate on the use of animals in research and testing on a much better informed footing.

You can view:

Details of project licences granted under ASPA in 2010 to 2012 are available on The National Archives.

Dealing with complaints and disagreements

The process below can be used if you are unhappy about any aspect of ASRU’s work. The process will be:

  1. contact ASRUBusiness@homeoffice.gsi.gov.uk
  2. in your e-mail set out the grounds for your concern and any supporting information.
  3. ASRU Business Support will record the concern. The concern will be passed to either a principal inspector or another manager within the unit to follow-up. The decision on who should investigate would be taken by the Head of Unit.
  4. the concern will be investigated and discussed with the member of staff concerned.
  5. a conclusion and recommendation from the concern will be drawn up and passed on to you, the staff member concerned and to ASRU Business Support to record its completion.
  6. we will endeavour to complete this process within 30 days. Should this not be possible you will receive an e-mail within the 30 days explaining why the process will take longer to complete.

For serious matters around the revocation, granting or variation of licences the formal procedure under section 12 of ASPA should continue to be used.

Annual reports

The 2017 annual report of the Animals in Science Regulation unit describes its work during 2017 in regulating work under ASPA as amended in 2012.

You can also read previous annual reports in the Animals in Science Regulation Unit annual reports collection.

Newsletters

The Animals in Science Regulation Unit newsletters are sent out by the ASRU. If you have any questions regarding their content please email ASRUBusiness@homeoffice.gsi.gov.uk

Published 26 March 2013
Last updated 3 December 2018 + show all updates
  1. Updated to add 2017 annual report
  2. Added a new section called, Project Licence Standard Condition 18 notification.
  3. Published 2016 annual report
  4. Updated guidance.
  5. Added 2016 scientific procedures on living animals report.
  6. Newsletter published.
  7. Latest newsletters published.
  8. 2017 annual return form and guidance published.
  9. Newsletter added
  10. Updated application guidance published
  11. Updated scientific procedures on living animals link to the 2015 publication.
  12. Information about working with animals taken from the wild included.
  13. Guidance on standard breeding protocols for genetically modified animals
  14. Added non-technical summaries for projects granted in 2014.
  15. Guidance on the use of human material in animals published.
  16. Form for 2016 annual returns of procedures published.
  17. Updated instructions for the annual returns procedures 2015 published.
  18. New animal use data return procedures form published.
  19. Removed form for outstanding returns from 2014.
  20. Three advice notes published.
  21. Updated guidance.
  22. Updated overview summary.
  23. Updated version.
  24. Explanatory memorandum to the code of practice for the care and accommodation of animals published.
  25. Code of practice for the care and accommodation of animals (short guide) published.
  26. Added links to 'Statistics of scientific procedures on living animals, Great Britain 2012' and 'Animals in Science Regulation Unit Annual Report 2012'.
  27. Link to section 24 online consultation added.
  28. Guidance on Animals (Scientific Procedures) Act 1986 (ASPA) has been published.
  29. Guidance on the naming of products and substances in project licences for batch quality control and regulatory toxicology added.
  30. Volume 1 of the non-technical summaries from licences granted during 2013 released.
  31. Annual returns instructions, notes and form updated
  32. First published.