Research and testing using animals
Details of the law on scientific research and testing involving animals, and guidance on applying for licences.
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.
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 transpose European Directive 2010/63/EU on the protection of animals used for scientific purposes. The revised legislation came into force on 1 January 2013.
We have prepared this document for our own internal purposes and are making it available for information. Please do not take the document to be a definitive statement of the law.
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.
Guidance on the operation of the Animals (Scientific Procedures) Act 1986
Guidance on the Operation of ASPA was published on 13 March 2014.
The guidance is intended to be a reference document that explains how the act is administered and enforced and provides detailed guidance to holders of establishment licences, project licences and personal licences and new licence applicants. In developing the guidance we consulted widely with stakeholders and the Animals in Science Committee. Copies of the guidance can be purchased from TSO bookshop using the ISBN 9780108561290.
There are several topics on which we will wish to publish further advice such as guidance on the use of animals containing human material, re-use of animals, re-homing animals (especially cats and dogs) and use of wild animals and their return to the wild.
An explanatory memorandum was also laid in Parliament.
Applying for licences
Three licences are required by the ASPA before testing on animals is permitted:
- a personal licence for each person carrying out procedures on animals
- a project licence for the programme of work
- an establishment licence for the place at which the work is carried out
If you have any further queries regarding applying licensing please contact your single point of contact. If you are currently not an employee of a licensed establishment please contact firstname.lastname@example.org.
Application forms and guidance notes
Applications for personal licenses and amendments are made through our e-licensing system, ASPeL. Please read the ASPeL user guidance (PDF, 545KB, 63 pages) , named officials at establishments will be able to provide assistance in completing the application.
You can download:
- project licence: application form (MS Word Document, 225KB) or the application form for changing a project licence
- the establishment licence form or the application form for changing an establishment licence
- standard breeding protocols for genetically altered mice (and other species with modification) (ODT, 56.6KB) and notes on the use of standard breeding protocols (PDF, 101KB, 2 pages)
Applicants are strongly advised to contact their local Home Office inspector before starting to complete the form. The project licence application form states the legal basis for the information we require to assess an application. It is intended to minimise unnecessary bureaucracy without compromising animal welfare. We are developing an online application process which will integrate with the new form.
It is important that any named person responsible for animal welfare under ASPA is aware that they should declare any conflict of interest. They must not be in a position where he or she does not put his/her overriding welfare obligations to the animals first. A person with a controlling financial interest or a substantial interest in the scientific outcome of a project might be presumed not to be suitable as such a named person in the absence of compelling circumstances to the contrary.
In order for the Secretary of State to determine whether an individual nominated to be such a named person is suitable, it is important to be fully aware of any real or perceived conflicts of interest which exist. A separate declaration should be completed by each person nominated by an establishment licence holder to be such a named person and should accompany the application for designation of an establishment, or the application for change(s), as appropriate.
Common errors in project applications
Note the following common errors in application forms:
- In section 18 (part d, plan of work, on new form) the protocols are described rather than discussed, and not discussed in relation to the objectives.
- The justification for the choice of model, together with the choice of species and the consideration with the alternatives, is lacking in section 18 (part d, plan of work, on new form).
- Consideration of reduction, refinement and replacement is not adequately handled.
- The objectives set out in section 17 (part c, purpose, on new form) are too vague and non-specific and the benefits are not realistically linked to the objectives.
- The background described in section 17 (part c, purpose, on new form) fails to take account of the progress of others in the topic and to identify clearly what needs to be discovered.
- Amendments are offered without an explanation or with an inadequate explanation or justification in section 18 (part d, plan of work, on new form).
- The 19b protocol (part e, protocols, on new form) contains too much text, much of which is either descriptive or restrictive.
- Clear end-points are not set in relation to predicted adverse effects.
- The difference between re-use and continued use of animals is not appreciated.
Where to send completed application forms
In the case of personal applications, completed forms should be sent via the applicant’s certificate-holder to the local office. Project application forms should be sent via the applicant’s establishment licence-holder to the local office. Correspondence should be addressed to the Home Office and not a named official.
Animals in Science Regulation Unit
1st floor Peel Building, North East Quarter
2 Marsham Street
Duty manager: 020 7035 0477
PO Box 1138
Dealing with disagreements
We aim to deal with disputes or disagreements fairly and openly. The process for requesting a second opinion on decisions, which can be started by an Animals in Science Regulation Unit (ASRU) inspector or an individual, is described in our ‘route map’ document.
When this approach is unsuitable or has not worked, it may be necessary to use the formal appeals process as described in section 12 of ASPA. It is intended to be used when the Secretary of State proposes to refuse, vary or revoke an authorisation.
The documents in this section and the form to provide data are frequently reviewed and we ask users to always check this webpage to ensure they are using the most up-to-date versions. We welcome feedback on the documents and the form.
This form should only be used for procedures completed during 2016, including for those licences which expired or were revoked during 2016.
The Return of procedures - animal use data 2016 (XLSM, 419KB) should be completed according to the below guidance documents – please refer to these when completing your return. After clicking on the link for the form, click ‘save’, choose an appropriate folder, and click ‘save’ again. This will ensure that macros are automatically enabled when opening the form, which will in turn ensure that the form validates properly.
Instructions for completion of 2016 annual return of procedures (PDF, 119KB, 24 pages)
- Advisory notes on actual severity reporting of regulated procedures (PDF, 165KB, 19 pages) sets out the general principles to enable project licence holders, and those appointed by them, to accurately and consistently assign severity assessments on completion of regulated procedures
- Advice on severity assessment of genetically altered animals (PDF, 87.6KB, 10 pages) advises on the specific issues relevant to the assessment of severity of animals on ‘breeding and maintenance’ protocols
Code of practice for the care and accommodation of animals
The code of practice sets out the standards of care and accommodation of animals required by ASPA, and provides advice about the way in which those responsible under ASPA may comply with those requirements.
The intention of the code is to ensure that the design, construction and function of the installations and equipment of licensed establishments – along with their staffing, care and practices – provides for scientific procedures to be carried out as effectively as possible.
The code is in 3 sections covering both general and species specific indications:
- section 1 describes the legal minimum standards applicable until 31 December 2016
- section 2 describes the legal minimum standards applicable from 1 January 2017
- section 3 provides non-mandatory advice to assist licensees to comply with the standards and covers a broader range of subjects than sections 1 and 2 alone
The code of practice is also available to download split by species:
- rodents and rabbits
- dogs, cats and ferrets
- non-human primates, farm animals and birds
- fish, amphibians, reptiles and cephalopods
You can read the Explanatory memorandum: code of practice for the care and accommodation of animals (PDF, 75.6KB, 3 pages) or (print-ready version) (PDF, 68.6KB, 4 pages) .
Transparency going forward
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.
Animals in Science Committee
The government’s response to the Animals In Science Committee’s review on investigations into non-compliance.
Annual report of the Animals in Science Regulation unit
The 2014 annual report describes the work of the unit during 2014 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.
Household products testing ban
The Household products testing ban advice note (PDF, 99.8KB, 15 pages) describes the implementation of a policy ban on the testing of finished household products and the requirements in relation to the testing of ingredients for household products on live animals under the terms of ASPA. The policy concerns tests on animals for the assessment of the safety of household products for humans, animals and the environment.
Guidance on the use of human material in animals
The Academy of Medical Sciences (AMS) published a report in 2011 that considered research involving the introduction of human DNA sequences into animals, or the mixing of human and animal cells or tissues. Such procedures create entities which are termed ‘animals containing human material’ (ACHM). Within this report the AMS recommended that the Home Office develop guidance on the use of human material in animals that details the authorities required when considering work with ACHM.
This guidance brings together information on the various regulations and guidance surrounding the use of animals containing human materials and the relevant authorities. It has been created in collaboration with the Human Tissue Authority, the Human Fertilisation and Embryology Authority and the Academy of Medical Sciences.
Use, keeping alive and re-use
The Use, keeping alive and re-use advice note (PDF, 123KB, 21 pages) explains the interpretations of the terms ‘use’, ‘re-use’ and ‘continued use’ under ASPA. It also provides advice on the criteria that must be satisfied to keep animals alive at the end of a series of regulated procedures.
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.
The harm–benefit analysis process (PDF, 2.08MB, 37 pages) conducted by Home Office inspectors, is the cornerstone of the licensing system for the use of animals in science and judges whether the likely harms to animals can be justified by the likely benefits. The Home Office has already published a paper on the purpose of the harm - benefit analysis as an appendix of the operational guidance. This advice note describes how the harm-benefit analysis is conducted operationally.
Re-homing and setting free
The purpose of this Advice note re-homing and setting free (PDF, 686KB, 49 pages) is to provide information on the legal requirements and guidance on current best practice in re-homing and setting free. The Home Office expects that every opportunity will be taken to re-home animals where it is appropriate to do so. This advice note explains the criteria required for the Secretary of State to consent for the re-homing or setting free at the end of procedures of relevant protected animals that have been bred, supplied, kept or used in regulated procedures.
Working with animals taken from the wild
The working with animals taken from the wild (PDF, 949KB, 63 pages) advice note provides information about how the ASPA requirements affect scientific or educational work using animals taken from the wild, including feral and stray animals. This includes information about:
- methods of capture
- identification (ringing, tagging or marking animals)
- working with animals at places which are not ASPA licensed establishments
- setting animals free in the course of regulated procedures which have not yet ended
- legal and licensing requirements
The full report of the 2015 statistics on scientific procedures on living animals was published on 20 July 2016.
You can also view previous reports in the Statistics of scientific procedures on living animals collection.
Non-technical summaries (abstracts)
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.
Abstracts before March 2010 are on the archived version of the Animals in Scientific Procedures website.
Published: 26 March 2013
Updated: 20 July 2016
- 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.