Animal testing and research: guidance for the regulated community

Animals in Science Regulation Unit (ASRU) guidance and regulatory advice

You can read ASRU guidance that explains how the act is administered and enforced including detailed regulatory advice for licence holders

• Household products testing ban

• Guidance on the use of human material in animals

• Use, keeping alive and re-use

• Harm-benefit analysis

• Re-homing and setting free

• Working with animals taken from the wild

• Code of practice for the care and accommodation of animals

• Efficient breeding of genetically altered animals

• Severity classification of genetically altered animals

• Recording and reporting the actual severity of regulated procedures

• Process and standards for establishment full system audits

• Standard genetically altered rodents protocols (PDF, 280 KB, 40 pages)
• Standard genetically altered zebrafish protocols (PDF, 263 KB, 28 pages)

• Guidance on the use of standard genetically altered animals protocols (PDF, 104 KB, 5 pages)

• Guidance notes for project licence applications

From 5 July 2021, ASRU now provides regulatory delivery through 2 teams covering different areas each of which has a dedicated inbox. Read the Bridging ways of working guidance for advice.

Apply for licences

Three licences are required by the Animals (Scientific Procedures) Act 1986 (ASPA) before testing on animals is allowed. The 3 licences needed are:

• 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

You should use the Animals in Science Procedures e-Licensing (ASPeL) system for all personal and project licence applications.

Contact your establishment’s Home Office liaison contact/administrator to start your application online.

If you are from an establishment that is not yet licensed, email ASPELTechnicalQueries@homeoffice.gov.uk.

Any named person responsible for animal welfare on the establishment licence will need to complete a conflict of interest declaration form.

Before applying, please read the standard conditions for personal licences, project licences and establishment licences.

You can also read guidance on:

• data protection impact assessment for the Animals in Science Procedures e-Licensing system

Add a named person role

People in named person roles are responsible for specific activities under the establishment licence (PEL), and you must add their names to the PEL in ASPeL. For example, the Named Animal Care and Welfare Officer (NACWO) oversees the care and welfare of animals.

Read about the requirements for named person roles in

• section 3.8 and section 8 in Guidance on the operation of ASPA.

• Guidance for training and continuous professional development under ASPA

When you add a named person 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 Veterinary Surgeon role

Any named person responsible for animal welfare on the PEL will need to complete a conflict of interest declaration form.

Prospective authority licensing requests

Animal studies carried out to meet regulatory requirements will be performed in compliance with UK and EU legislative bodies.

Where studies are performed for other regulatory bodies, for example the US, and the study requirements exceed the UK or EU regulatory requirements, you must submit a prospective authorisation request form to ASRU.

The project licence holder at the establishment should complete the Prospective authorisation form (MS Word Document, 107 KB). Submit the completed form to asrulicensing@homeoffice.gov.uk.

Project Licence Standard Condition 18 notification

All project licences are subject to a set of standard conditions. Standard Condition 18 requires that the project licence holder (PPLh) notifies the Secretary of State as soon as possible if constraints on the severity limits, or observance of other controls described in the licence, have been breached or are likely to have been breached.

You can read the Advice note - Project Licence Standard Condition 18 Notification (PDF, 544 KB, 22 pages), and use the form Project Licence Standard Condition 18 Notification form (ODT, 31.8 KB) to make reports.

Annual returns on the use of protected animals

Statistics are collected annually in the UK 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, read the guidance on the annual returns process.

Newsletters

The Animals in Science Regulation Unit newsletters are sent out by the ASRU. If you have any questions about their content, email asruoperationalrelationshipmanagement@homeoffice.gov.uk.

Register for updates

Sign up for email updates on this topic.

Contact information

Use ASRULicensing@homeoffice.gov.ukasrulicensing@homeoffice.gov.uk for:

• specific queries relating to an individual licence application

• evidence to support an exemption from mandatory training

• requests to re-home animals where not already authorised

• advice on interpretation of licence authorities

• guidance on becoming an establishment

• advice on whether work needs to be regulated

• advice on applying for licences

• guidance on how we will assess applications

• information to support a PEL application or amendment notification of AWERB dates

• AWERB terms of reference

Use ASRUEnforcement@homeoffice.gov.ukasruenforcement@homeoffice.gov.uk for:

• 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

Use ASRUStandardCondition18@homeoffice.gov.ukasrustandardcondition18@homeoffice.gov.uk for:

• requests to keep animals alive

• Standard Condition 18 reports

Use ASRUAudit@homeoffice.gov.ukasruaudit@homeoffice.gov.uk for:

• audit related queries

Use ASPELTechnicalQueries@homeoffice.gov.ukaspeltechnicalQueries@homeoffice.gov.uk for:

• technical advice on the use of ASPeL

Use ASRUOperationalRelationshipManagement@homeoffice.gov.uk for:

• raising concerns about the timeliness or completeness of response from any of our teams or any other concerns about any individual request or interaction

• raising concerns about the timeliness or completeness of response from any of our teams or any other concerns about any individual request or interaction from the regulated community

Use ASRUPOLEnotification@homeoffice.gov.ukasrupolenotification@homeoffice.gov.uk for:

• notifying ASRU of upcoming work at a POLE - please ensure the email subject line includes the PPL number, PPL holder’s surname and the name of the establishment

Report a non-compliance

Please use this form to notify ASRU of any incidents where there has been a potential breach of ASPA or a licence condition, this includes the code of practice.

Potential non-compliance notification form (MS Word Document, 85.4 KB)

Provide as much information as possible. Incidents of non-compliance should be reported to ASRU. Self-reporting indicates that an establishment is making efforts to ensure compliance. It demonstrates that role holders are aware of their responsibilities and are committed to building a compliant culture.

ASRU expects self-reporting to be embedded within good governance frameworks and that employees are aware of the process for raising concerns within their establishment. This is set out in ASRU’s published compliance policy and guidance on the operation of the ASPA.

Complaints feedback

If you want to give feedback on how we handled your complaint, please email asruoperationalrelationshipmanagement@homeoffice.gov.uk.

Make a complaint

Please only complete this complaints form if you wish to make a formal complaint.

Please send the completed form to asruoperationalrelationshipmanagement@homeoffice.gov.uk.