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.
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 9780108560316.
An explanatory memorandum was also laid in Parliament.
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.
Animals in Science Committee
The government’s response to the Animals In Science Committee’s review on investigations into non-compliance.
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
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) .
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.
Always check this page to ensure that you are using the most up-to-date returns and guidance notes. We welcome feedback on these documents.
The return of procedures - animal use data 2017 (XLSM, 472KB) form should only be used for procedures completed during 2017.
Refer to the guidance documents below when you complete your form. 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 ensure that the form functions properly.
Instructions for completing 2017 annual return of procedures (PDF, 319KB, 27 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.
Additional data collection for 2017
Once every 5 years, and in accordance with PEL Standard Condition 8, PEL Holders are required to provide information relating to:
the number of animals that were bred for scientific procedures and were killed during the target year but not used in procedures and not included in the annual return of procedures
Tissue sampling and its refinements for genotyping of animals.
These draft summary tables (ODS, 8.33KB) show what data each establishment will need to provide by 31 January 2018. Later in the year we will provide the final version of the tables that should be used to return your data. Please read the additional explanatory notes (PDF, 502KB, 5 pages) carefully.
If you have any queries about this data collection please email ASRUBusiness@homeoffice.gsi.gov.uk
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.
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.