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.
Animals in Science Regulation Unit (ASRU) Guidance
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.
The full report of the 2016 statistics on scientific procedures on living animals was published on 13 July 2017.
You can also view previous reports in the Statistics of scientific procedures on living animals collection.
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
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:
- non-technical summaries granted in 2015
- non-technical summaries granted in 2014
- non-technical summaries granted in 2013
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:
- contact ASRUBusiness@homeoffice.gsi.gov.uk
- in your e-mail set out the grounds for your concern and any supporting information.
- 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.
- the concern will be investigated and discussed with the member of staff concerned.
- 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.
- 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.
The 2015 annual report of the Animals in Science Regulation unit describes its work during 2015 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.
Investigations into non-compliance
In the 2013 annual report of the Animals in Science Regulation Unit, we set out details of plans to start publishing anonymised reports of substantial investigations.
The publication of such investigations may be triggered by a number of factors including, but not limited to:
- an exposé making allegations in the public domain
- a cluster of non-compliances or ‘near misses’ triaged by an inspector to ASRU management
- a non-compliance apparently involving significant animal harm
- a published paper that appears to describe unjustified pain, suffering or distress
- concern raised by inspectors or others that a particular procedure may not optimally implement the 3Rs
We believe the early publication of these investigations is in the interests of transparency and openness. We believe that this will also help ensure that all stakeholders can learn from the outcomes of these investigations as early as possible and enable them to address any potential weaknesses in their own management systems, creating a cycle of continuous improvement. These reports will also provide the public with an insight into this important aspect of ASRU’s work.
You can read the government’s response to the Animals In Science Committee’s review on investigations into non-compliance.
Patterns of low level concerns
The Patterns of low-level concern (PDF, 334KB, 16 pages) describes the approach that is taken when inspectors identify low-level concerns. The identification of low-level concerns in an establishment are not in themselves breaches of ASPA or licence conditions but, taken together, form a pattern which could indicate that a management and/or welfare regime may have weaknesses which could pose an increased risk of non-compliance or adverse animal welfare.
Published: 26 March 2013
Updated: 29 August 2017
- Updated guidance.
- Added 2016 scientific procedures on living animals report.
- Newsletter published.
- Latest newsletters published.
- 2017 annual return form and guidance published.
- Newsletter added
- Updated application guidance published
- Updated scientific procedures on living animals link to the 2015 publication.
- Information about working with animals taken from the wild included.
- Guidance on standard breeding protocols for genetically modified animals
- Added non-technical summaries for projects granted in 2014.
- Guidance on the use of human material in animals published.
- Form for 2016 annual returns of procedures published.
- Updated instructions for the annual returns procedures 2015 published.
- New animal use data return procedures form published.
- Removed form for outstanding returns from 2014.
- Three advice notes published.
- Updated guidance.
- Updated overview summary.
- Updated version.
- Explanatory memorandum to the code of practice for the care and accommodation of animals published.
- Code of practice for the care and accommodation of animals (short guide) published.
- Added links to 'Statistics of scientific procedures on living animals, Great Britain 2012' and 'Animals in Science Regulation Unit Annual Report 2012'.
- Link to section 24 online consultation added.
- Guidance on Animals (Scientific Procedures) Act 1986 (ASPA) has been published.
- Guidance on the naming of products and substances in project licences for batch quality control and regulatory toxicology added.
- Volume 1 of the non-technical summaries from licences granted during 2013 released.
- Annual returns instructions, notes and form updated
- First published.