Research and testing using animals: licences and compliance

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:

• Named Animal Care and Welfare Officer role
• Named Information Officer
• Named Training and Competency Officer
• Named Veterinary Surgeon role
• Suitably Qualified Person role

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

 ReportReport 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

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.