Correspondence

ASRU operational newsletter, September 2025

Published 19 September 2025

Introduction

Dear All,

This ASRU operational update contains information for Home Office Liaison Contacts, licence holders, named persons and other role holders under ASPA.

The information aims to ensure you are updated and informed on the regulatory services delivered by the Animals in Science Regulation Unit (ASRU). Information provided aims to clarify ASPA requirements, help support compliance and inform on licensing requirements.

If you have any feedback or suggestions for future editions of this newsletter, please contact us via ASRUOperationalRelationshipManagement@homeoffice.gov.uk.

News – reform update

ASRU is currently in the final stage of our reform process and we expect this will continue until early 2026.

Our reform process will help us to deliver our purpose of protecting animals (by maintaining compliance with the law) most effectively and deliver an excellent service to the science sector to facilitate scientific progress.

ASRU will be onboarding and training new staff throughout 2025 and early 2026. We will keep you updated if we expect this to affect our regulatory services.

Compliance

In line with continuous improvement measures, SC18 reports submitted by establishments are not returned with comments from ASRU officials unless the case has been referred to enforcement for follow-up actions.

Redirecting resource in this way will strengthen delivery across other regulatory activities and improve overall service delivery. Establishments will no longer receive a formal ‘case closed’ notification instead, they will receive a response that sets out a reference ID.

ASRU officials will contact establishments if further information is required. Service Level Agreements (SLAs) are currently under review and will be communicated in due course.

Licensing

Project licence amendments are currently being processed within 40 days. This service level will be reviewed later this year once recruitment has completed.

If you are submitting an urgent or very simple amendment, please email ASRULicensing@homeoffice.gov.uk. This will enable us to process these more quickly where possible.

New policy – Breeding of non-human primates

A new policy relating to the breeding of non-human primates (NHPs) became active on 1st August. This is relevant to establishments which breed or use these animals.

In June 2022, the Animals in Science Committee (ASC) was commissioned to provide advice on questions relating to the breeding of NHPs for use in scientific procedures. This was to address concerns around the catching of wild animals for breeding. In September 2022 the ASC produced a report with 16 recommendations.

Following stakeholder engagement by the Animals in Science Regulation Policy Unit (ASRPU), the Home Office has now responded to the ASC’s report. A policy paper has been produced which includes key changes relevant to establishments breeding and using NHPs, and to ASRU’s regulatory activity.

The policy became active on 1st August 2025 and will be published by the ASC soon; key details have been shared with affected establishments and within ASRU. The policy includes:

• new definitions relating to NHPs’ generational status and self-sustaining colonies
• new requirements for establishments in terms of assigning generational status and ensuring maintenance or use of self-sustaining colonies
• related new restrictions on acceptable use of NHPs in project licences, which are applicable from 1st August 2025
• related new audit requirements for relevant establishments, from January 2026

ASRU is currently developing processes to support regulation of these new requirements. We anticipate that this will not add significant burden to affected establishments and aim to share further detail by the end of September.

In the meantime please:

• continue to submit project licence applications involving NHPs as usual. Expect additional questions to be asked during the assessment process
• contact ASRULicensing@homeoffice.gov.uk if you are an NHP breeding establishment and are considering introducing new animals which may come from a colony not meeting the new definition of “self-sustaining”
• start developing your NHP sustainability plan or consider how you will demonstrate due diligence in ongoing compliance with colony requirements (per details shared via ASRPU), as applicable to your organisation

Background information on this policy change can be found here:

• Commission of advice: non-human primates bred for use in scientific procedures (accessible).
• Letter to Lord Sharpe advising on non-human primates bred for use in scientific purposes.
• Advice on non-human primates bred for use in scientific purposes (ASC report).

For queries pending further advice, please contact ASRULicensing@homeoffice.gov.uk.

Fees

We would like to thank you for working with ASRU for payment of annual fees. The fees ensure that ASRU is resourced to continue to provide the rigorous and robust requirements set out under the regulatory framework, assuring the compliance, quality science and engendering of public trust that is fundamental in the delivery of the UK life sciences.

There are currently no planned changes to the fee structure and we will inform you if this position changes. Please contact us if you have any questions or require assistance on fee issues via ASRUOperationalRelationshipManagement@homeoffice.gov.uk.

ASPeL updates

Changes to ‘Animals used in this protocol’ section in the project licence application form.

Issue addressed

In the ‘Animals used’ section in protocols, the wording and sequence of questions around re-use of animals and numbers of animals being used was confusing for applicants and causing inspectors to return their project licence (PPL) applications.

Also, it was difficult for users to see which animal type the questions related to in the screen.

Changes made

Improved the wording and sequence in the questions to meet policy intent and help users understand what’s being asked.

We expect this to provide more accurate information to inspectors who need to know if establishments are intending to re-use animals in either, or both, of two ways:

• past use on another protocol, either in the same project or on another project, and brought onto the protocol (but meeting the definition of re-use, not continued use)

• re-use within this protocol, and the maximum number of times.

The ‘Animals used’ questions also now include the animal type for added clarity.

Notes

• ‘continued use’ describes animals that are specifically genetically altered and bred for scientific use, or animals that have had procedures applied to them to prepare them for use in this protocol

• ‘re-use’ describes using an animal for a new experiment when you could equally use a naïve animal to get the same results

• either re-use request triggers authorisations that go in the licence

Fixes to change display throughout the project licence form – change flags

When users, both applicants and inspectors, make changes to a draft or amended project licence, CHANGED flags are displayed in ASPeL. We have updated the code to ensure that change flags are displayed correctly for all the issued raised, for:

• Pink CHANGED – this flag is displayed when the value of a question, or a question within a section has been changed in the most recent submission

• Grey CHANGED – this flag is displayed when there has been a previous change in an application that doesn’t have a granted PPL i.e. there is no difference between current and previous versions but there is a difference between the current and base versions in the draft application

• Grey AMENDED – this flag is displayed when there has been a previous change in an amendment to a granted PPL i.e. there is no difference between current and previous versions but there is a difference between the current and base versions in the amendment

• No flag display – we have fixed scenarios where a false flag was being displayed i.e. when there is no net change in a submission. When new protocols and new steps are added and removed, or removed and reinstated, then no change flag is displayed.

‘See what’s changed’

• the severity level text (mild, moderate or severe) is now displayed correctly in existing and new project licences
• Life stage text is now displayed in the ‘Animals used’ section in protocols
• red and green colours now display correctly for all text changes

Changes to Returns of Procedures for transferred project licences

Issue addressed

Prior to these changes, when a project licence was amended by being transferred to a new establishment, any previously submitted Returns of Procedures were not transferred with the licence and so were not available to the project licence holder (PPLh) in the new establishment.

This led to requests for ASRU to send data to customers for transferred Returns.

Changes made

Now, when you move a project licence to a new establishment, the Returns are transferred with the licence. This means that the PPLh in the new establishment can view and edit any previously submitted Returns.

Note

The previous establishment loses access to view the project licence and any previously submitted Returns – we haven’t changed this.

• In addition, the PPLh in the new establishment can now view the project licence history.

• For overdue Returns, email remainders are sent and in-ASPeL notification banners are now displayed only to the current establishment.

• During the transfer journey, a warning messaging is displayed to the Establishment Admin user (PELh) in the endorsement screen, prompting them to download any previously submitted returns before endorsing the transfer of the project licence to the new establishment.

Named person guides live on GOV.UK

Issues raised

When applying for named person roles, applicants did not often provide the right information to support the application, especially for NACWO and NVS roles – for example details of their mandatory training, or evidence for an exemption, such as learning outcomes covered by other courses or species-specific learning outcomes covered by clinical practice.

Guidance related to these requirements was hard to find and spread across multiple documents on GOV.UK.

Changes made

We have created new step-by-step guides to help establishments when they are adding named person roles. These guides bring the information together into one place. Links to the new NACWO and NVS guides on GOV.UK:

• add a named person role

• nominate someone for a named animal care and welfare officer role

• nominate someone for a named veterinary surgeon role

The other named person role guides are waiting for final approval and will be live soon.

We have also worked to reorganise the ASRU pages on gov.uk, so they are easier to navigate, and things are grouped together logically.

Stakeholder engagement

ASRU held stakeholder update sessions with the Home Office Liaison, Training and Information Forum (HOLTIF) and the Establishment Licence Holders (PELh) in July and with the Laboratory Animal Veterinary Association (LAVA) in August. The sessions included updates on regulatory delivery, the transformation programme and ASPeL changes and associated benefits.

The PEL Committee and HOLTIF are sections of the Laboratory Animals Science Association (LASA), set up to provide representation between the Home Office, and licensed named people under the Animal (Scientific Procedures) Act 1986.

ASRU meets with key stakeholder to provide regulatory updates and answer questions from the sector. If you would like to know more about joining the PELh Committee, HOLTIF or LAVA please contact ASRUOperationalRelationshipManagement@homeoffice.gov.uk

Publications

• Guidance to nominate someone for a Named Veterinary Surgeon (NVS)

• ASRU 2023 annual report.

• Non-Technical Summaries and Retrospective assessments for October to December 2024.

Amendment to April 2025 Newsletter

We have made the following correction to the information published in our April 2025 newsletter. We apologise for the error and appreciate your understanding: Licensing section, starting ‘When submitting amendments….’

When submitting amendments, please consider providing supporting evidence such as:

• photographs of newly refurbished rooms to demonstrate compliance with the Code of Practice (COP)

• statements from the Named Veterinary Surgeon (NVS) Establishment Licence holder, confirming that the room meets the required standards, in accordance with establishment licence Standard Condition 4

This will facilitate the completion of due diligence checks before applications can be accepted. This evidence should be sent to ASRUlicensing@homeoffice.gov.uk advising the team that it is for a recently submitted PEL amendment.

What we do with your data and who sees it

The data provided by you and your establishment(s) is used by ASRU, the Animals in Science Committee and trusted, security vetted, government suppliers to assess the suitability of licence applications. It is also used to process metrics that are used to help improve the service that ASRU provides.

The information you provide to the Home Office as part of a licence application is considered by us to be information provided in confidence and the release of this information is prohibited under section 24 of the Animals (Scientific Procedures) Act 1986. This may also apply where the Home Office restates the information supplied in the course of its decision-making. The non-technical summaries supplied as part of the process are not treated by the Home Office as having been provided in confidence.

Information provided in the non-technical summaries of project licences, and in the annual statistics, will be de-identified before being published on GOV.UK. De-identified data may also be used to answer Parliamentary Questions, Freedom of Information requests, and other types of correspondence, unless disclosure of that information is prohibited by section 24 of the Animals (Scientific Procedures) Act 1986.

We will only ever share any identifiable data if we are required to do so by law – for example, by court order, or to prevent fraud or other crime.

Regards, Animals in Science Regulation Unit