Research and testing using animals: licences and compliance
How to apply for licences and stay compliant if you use, breed or supply animals under the Animals (Scientific Procedures) Act 1986.
Overview
The Animals (Scientific Procedures) Act 1986 (ASPA) is the main legislation that protects animals used for scientific purposes.
The government is committed to the protection of animals through the implementation of the 3Rs (reduction, replacement and refinement) across all licensed projects involving animals in science.
In England, Scotland and Wales, you need 3 licences from the Home Office before you can carry out procedures using living animals:
- an establishment licence for the place where the work is carried out
- project licences for the programmes of work
- personal licences for each person carrying out procedures on animals
The Animals in Science Regulation Unit (ASRU) is part of the Home Office and is responsible for issuing licences and making sure establishments comply with ASPA.
In Northern Ireland, the Department of Health is responsible for licensing and compliance.
ASRU has 2 teams who support establishments with licensing and compliance. Read the bridging ways of working guidance for more information.
All licence applications should be made in the Animals in Science Procedures e-Licensing (ASPeL) system.
Minimum legal standards and guidance
ASPA sets out the framework for regulating the use of animals in science and research. The following set out minimum legal standards and guidance under ASPA.
Code of practice
Section 2 of the code of practice describes the minimum legal standards for the housing and care of animals bred, supplied or used for scientific purposes. Section 3 provides non-mandatory advice to encourage establishments to continuously improve their standards of housing and care for better animal welfare.
Standard conditions for licences
ASRU grants licences subject to standard conditions, which are the minimum legal requirements of a licence.
There are:
- establishment licence standard conditions
- project licence standard conditions
- personal licence standard conditions
Guidance on the operation of ASPA
The guidance on the operation of ASPA explains how the act is overseen and enforced, and sets out the responsibilities of those with roles under ASPA.
It provides detailed guidance to licence holders and applicants on topics including minimum legal standards, severity classifications and humane killing.
Guidance on training and continuous professional development under ASPA
The guidance on training and continuous professional development under ASPA sets:
- the governance framework for training and continuous professional development
- specific training requirements for licensing under ASPA
- the learning outcomes of the training required
It includes both minimum legal standards and guidance.
Technical advice notes
The technical advice notes provide further detailed advice on how to comply with ASPA. (Reference to each specific advice note is included where it is relevant in the ‘apply for a project licence’ section of this page.)
Apply for an establishment licence (PEL)
If you are from an establishment that is not yet licensed, email aspeltechnicalqueries@homeoffice.gov.uk.
To help you apply online for a PEL, or amendment to a PEL, read section 3 of the guidance on the operation of ASPA.
All licensed establishments must have a PEL holder. The PEL holder or Named Person Responsible for Compliance will be responsible for compliance, including meeting the establishment licence standard conditions.
Add a named person role
People in named person roles are responsible for specific activities under the PEL, and their names must be added to the PEL in ASPeL. For example, the Named Animal Care and Welfare Officer oversees the care and welfare of animals.
Read about the requirements for named person roles in:
- section 3.8 and section 8 of the guidance on the operation of ASPA
- guidance on training and continuous professional development under ASPA
When a named person is added to a PEL, this is classed as an amendment.
Find out how to nominate someone for a:
Any named person responsible for animal welfare on the PEL will need to complete a conflict of interest declaration form.
Apply for a project licence (PPL)
Contact your establishment’s Home Office liaison contact or administrator to start your online PPL application.
To help you apply for a PPL, or amendment to a PPL, read:
- section 5 of the guidance on the operation of ASPA
- guidance notes for PPL applications
- information on ASRU’s harm-benefit analysis process and criteria they use when assessing an application (appendix I of the guidance on the operation of ASPA)
- guidance on the fate of animals at the end of procedures:
- section 6 on humane killing of animals in the guidance on the operation of ASPA
- use, keeping alive and reuse (PDF, 123KB, 21 pages)
Every licensed project must have a PPL holder, who will be responsible for compliance, including meeting the PPL standard conditions.
Using genetically altered animals
If you are applying to use genetically altered animals, use the relevant standard protocols in your PPL application:
- standard protocols for using genetically altered rodents (PDF, 280KB, 40 pages)
- standard protocols for using genetically altered zebrafish (PDF, 263KB, 28 pages)
Read guidance on using standard protocols (PDF, 104KB, 5 pages) for using genetically altered animals.
There is also guidance on:
- efficient breeding of genetically altered animals
- severity classification of genetically altered animals (when you are completing your annual return on procedures)
Testing household products
The testing of finished household products is banned under ASPA. Read the household products testing ban advice note for advice on the requirements for testing ingredients for household products.
Using human material in animals
If you are applying to use human material in animals, read the guidance on using human material in animals.
Working with animals taken from the wild
If you are applying to work with animals taken from the wild, read the guidance on working with animals taken from the wild and setting animals free.
Research for regulatory bodies outside the UK
If you are carrying out research for regulatory bodies outside the UK, for example the USA, and the study requirements exceed the UK regulatory requirements, you must submit a prospective authorisation request to ASRU.
The PPL holder should complete the prospective authorisation form (MS Word document, 107KB) and send the completed form to asrulicensing@homeoffice.gov.uk.
Apply for a personal licence (PIL)
Contact your establishment’s Home Office liaison contact or administrator to start your online PIL application.
To help you apply for a PIL, or amendment to a PIL, read section 4 of the guidance on the operation of ASPA.
PIL holders must comply with the personal licence standard conditions.
Submit your annual return
Under ASPA, ASRU must collect and publish annual statistics on the use of protected animals in regulated procedures .
PPL holders must record and provide data each year on procedures that have been carried out as part of their project - an annual return on procedures. Data returns must be completed in ASPeL at the end of the calendar year.
Prepare for an audit
ASRU carries out a range of audits at licensed establishments. The type of audit is decided by ASRU. The purpose is to assess whether licence holders are complying with ASPA, licence conditions and the code of practice, and to provide feedback to guide ongoing compliance.
You can read more about the audit process and the criteria inspectors use in:
- full system audit process (PDF, 221KB, 12 pages)
- evidence for assessment of compliance against ASPA and licence conditions (PDF, 298KB, 33 pages
Report non-compliance
Project, personal and establishment licence holders should self-report non-compliance to ASRU relating to potential breaches of:
- ASPA
- a licence condition
- the code of practice
To self-report, complete the potential non-compliance notification form (MS Word document, 85.4KB) and email it, as a Word document, to asruenforcement@homeoffice.gov.uk.
Provide as much information as possible, so ASRU can assess the case quickly and accurately.
Self-reporting demonstrates that licence holders are aware of their responsibilities and are committed to creating a culture of compliance in their establishments.
ASRU expects that:
- self-reporting is part of an establishment’s governance frameworks and culture of care
- employees know how to raise concerns within their establishment
ASRU’s full expectations are set out in their compliance policy and in section 12 of the guidance on the operation of ASPA .
Report a potential or actual breach of licensed severity limits (standard condition 18 notification)
PPL standard condition 18 (SC18) requires the PPL holder to comply with the severity limits (and other controls) set out in the PPL to limit the suffering of animals.
PPL holders must notify ASRU as soon as possible (within 72 hours) if:
- adverse effects from procedures have resulted in, or are likely to result in, higher levels of suffering than set out in the PPL
- controls set out in the PPL, such as humane endpoints, have been, or are likely to be, breached
- there have been adverse effects that are not set out in the PPL
For further information, read the advice note (PDF, 544KB, 22 pages) on SC18 notifications. To report a potential or actual breach, email the SC18 notification form (ODT, 31.8KB) to ASRUStandardCondition18@homeoffice.gov.uk.
Request to keep animals alive following a breach
If you plan to keep animals alive following a breach of licensed severity limits, you need authorisation from ASRU.
You must submit a request immediately using the SC18 notification form (ODT, 31.8KB). The 72-hour deadline for SC18 reports does not apply, because it is unlawful to keep animals alive when severity limits (or any other controls) in a PPL have been breached.
Email the form to ASRUStandardCondition18@homeoffice.gov.uk and label your email subject line ‘Urgent - Request to keep animals alive SC18’. Ensure you include the scientific justification for keeping the animals alive.
Business continuity planning
Business continuity planning guidance for establishments (PDF, 185KB, 13 pages) provides advice to PEL holders on the requirements for contingency planning, emergency response and business continuity planning.
Keep updated
Newsletters
If you want to receive newsletters from ASRU, or if you have any questions about their content, email asruoperationalrelationshipmanagement@homeoffice.gov.uk.
Register for updates
Sign up for email updates when there are changes to the content on animals in science licensing and compliance on GOV.UK.
Contact ASRU
To help ASRU handle your query quickly, ensure you only email the relevant inbox, as set out below.
Licence applications
This includes getting advice on:
- whether work needs to be regulated
- becoming an establishment
- applying for licences or amendments, including what information to provide
- providing evidence to support exemptions from mandatory training
- how ASRU will assess applications
- re-homing animals where not already authorised
- working with animals taken from the wild
- how to interpret authorisations in the licence
- Animal Welfare and Ethical Review Body terms of reference
Enforcement and compliance
This includes:
- reports of potential non-compliance
- reports required by a licence condition or as a result of enforcement action
- advice on whether a non-compliance may have occurred
- contact during a non-compliance investigation
SC18
This includes:
- requests to keep animals alive
- SC18 reports
Audit
Email: asruaudit@homeoffice.gov.uk
Technical advice on using ASPeL
Places other than licensed establishments
To tell ASRU about upcoming work at places other than licensed establishments, email asrupolenotification@homeoffice.gov.uk.
Make sure the email subject line includes the PPL number, PPL holder’s surname and establishment name.
Make a complaint
To raise any concerns about process or timeliness of responses to applications or queries, email the team using the relevant email address.
If you are not satisfied with the response, you can make a formal complaint by completing the online complaints form and emailing it to: asruoperationalrelationshipmanagement@homeoffice.gov.uk.
Complaints feedback
To give feedback on how ASRU handled your complaint, email asruoperationalrelationshipmanagement@homeoffice.gov.uk.
Data protection
You can read the data protection impact assessment for ASPeL.
Updates to this page
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Made the following changes: 1) Added an overview section to provide context on ASRU and licensing, with links to other relevant pages. 2) Added a section on minimum legal standards and guidance. 3) Updated the information on processes to follow, including clarifying the difference between reporting non-compliance and reporting a potential or actual breach of licensed severity limits.
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Added a new section 'Add a named person role'.
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Replaced Potential non-compliance notification form.
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Replaced Potential non-compliance notification form as a Word version.
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Added the prospective authorisation word document form.
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Added the prospective authorisation form and guidance.
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Adding information on the complaints procedure.
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Updated email address for requesting content about the ASRU newsletter.
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Non-compliance notification form published.
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Removed link to improving your project licence application - guidance is out of date.
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Added link to 'Guidance notes for project license applications' and new section on when to contact ASRUPOLEnotification@homeoffice.gov.uk.
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Added the following documents: standard genetically altered rodents protocols, standard genetically altered zebrafish protocols, guidance on the use of standard genetically altered animals.
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Updated email addresses under 'Apply for licence' and 'Contact information and forms'. Updated 'Register for updates' form link.
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Updated 'Bridging ways of working guidance' PDF.
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Added link to "Process and standards for establishment full system audits" in "Animals in Science Regulation Unit (ASRU) Guidance and regulatory advice" section.
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'Contact us' section updated to include (word) enquiry form.
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Bridging ways of working guidance added.
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Added link to non-technical summaries granted in 2020.
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Added link to non-technical summaries granted in 2019.
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Added a link to the 2019 statistics on scientific procedures on living animals.
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Updated to change link from 2017 annual report to 2018 annual report.
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Added a link to non-technical summaries granted in 2018.
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Added link to non-technical summaries granted in 2017.
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Added a link to the 2018 statistics on scientific procedures on living animals.
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Updated to add 2017 annual report
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Added a new section called, Project Licence Standard Condition 18 notification.
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Published 2016 annual report
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Updated guidance.
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Added 2016 scientific procedures on living animals report.
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Newsletter published.
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Latest newsletters published.
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2017 annual return form and guidance published.
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Newsletter added
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Updated application guidance published
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Updated scientific procedures on living animals link to the 2015 publication.
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Information about working with animals taken from the wild included.
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Guidance on standard breeding protocols for genetically modified animals
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Added non-technical summaries for projects granted in 2014.
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Guidance on the use of human material in animals published.
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Form for 2016 annual returns of procedures published.
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Updated instructions for the annual returns procedures 2015 published.
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New animal use data return procedures form published.
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Removed form for outstanding returns from 2014.
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Three advice notes published.
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Updated guidance.
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Updated overview summary.
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Updated version.
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Explanatory memorandum to the code of practice for the care and accommodation of animals published.
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Code of practice for the care and accommodation of animals (short guide) published.
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Added links to 'Statistics of scientific procedures on living animals, Great Britain 2012' and 'Animals in Science Regulation Unit Annual Report 2012'.
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Link to section 24 online consultation added.
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Guidance on Animals (Scientific Procedures) Act 1986 (ASPA) has been published.
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Guidance on the naming of products and substances in project licences for batch quality control and regulatory toxicology added.
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Volume 1 of the non-technical summaries from licences granted during 2013 released.
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Annual returns instructions, notes and form updated
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First published.