Open consultation

Consultation on the proposed revocation of authorisation for one regulated feed product - July 2026

Published 10 July 2026

This consultation seeks stakeholders’ views, comments and feedback in relation to the proposed revocation of an authorisation for one regulated feed product.

1. Launch date

10 July 2026 

2. Respond by

02 October 2026 

3. This consultation will be of most interest to

All England, Wales, and Northern Ireland food and feed businesses, local and port health authorities, district councils, and other stakeholders with an interest in food and feed safety.

As this consultation relates solely to England and Wales, it is important to note that Food Standards Scotland (FSS) is the independent authority responsible for food and feed safety in Scotland. FSS will consider the position for Scotland separately and determine in due course whether any corresponding measures should be taken.

This consultation is also available in Welsh (Cymraeg).

4. Purpose of the consultation

This consultation seeks stakeholders’ views, comments and feedback in relation to the proposed revocation of the authorisation of one feed additive.

5. How to respond

Responses to this consultation should be submitted via the online survey (opens in a new window).

If this is not possible, you can email a response to: 

RPconsultations@food.gov.uk 

Full details on how to respond are given below.

6. Definitions

The following information and definitions may be of use when responding to this consultation.

6.1 Regulated products

Certain food and feed products, called regulated products, must go through a risk analysis process, and require authorisation before they can be sold in the UK.

You can find out more about the application process, including the risk analysis and risk management processes, and ministerial involvement here: 

Background on placing a regulated product on the market

6.2 Assimilated regulations

Directly applicable EU legislation no longer applies in Great Britain. EU legislation, retained when the UK exited the EU, was assimilated on 01 January 2024.

References to any legislation with ‘EU’ or ‘EC’ in the title should now be regarded as assimilated law where applicable to Great Britain. Assimilated law is published on legislation.gov.uk. References to ‘Retained EU Law’ or ‘REUL’ should now be regarded as references to assimilated law.

6.3 Feed additive

Feed additives are substances, micro-organisms or preparations (other than feed materials and premixtures) which are intentionally added to feed or water to perform one or more specific functions.

The Food and Feed Safety and Hygiene Provisional Common Framework is a non-statutory arrangement between the UK Government and Devolved Administrations to establish common approaches to policy areas where powers have returned from the EU within areas of devolved competence.

This consultation has been developed to cover England and Welsh stakeholders. Final recommendations will be agreed before being presented to ministers in England and Wales, with the Northern Ireland Health Minister kept informed. Northern Ireland continues to fully participate in the risk analysis processes concerning food and feed safety. This reflects Northern Ireland’s integral role within the UK and ensures that any decision made fully considers the potential impacts on the whole of the UK.

6.4 Windsor Framework: feed additives

• The Windsor Framework provides a unique set of arrangements to support the flow of agri-food retail food products from Great Britain to Northern Ireland. These goods can meet the same standards applied in the rest of the UK in public health, marketing (including labelling) and organic foods when moving through the Northern Ireland Retail Movement Scheme (NIRMS). 

• The scheme extends to some pet food and dog chews. Feed for particular nutritional uses (PARNUTs) and feed additives, whether being used to produce compound feeds or being fed directly to livestock, would not be able to benefit from the scheme.

6.5 Safety assessment

The FSA and FSS risk assessors deliver the science behind our advice. They are responsible for identifying and characterising hazards and risks to health and assessing exposure levels.

6.6 Risk management

Our policy advisors are responsible for the risk management outputs. The FSA risk management recommendations document presents the factors that they have identified as relevant to these applications, including the potential impact of any decision made by ministers, and contain proposed terms of authorisation and other relevant provisions.

7. Details of consultation

7.1 Introduction

This consultation seeks views on the proposed revocation of authorisation of one feed additive (a regulated product).

An overview of the details can be found later in this document. For full and further information, please refer to the technical documents of the FSA and FSS safety assessments and the FSA risk management recommendations document, which is hyperlinked in this document.

Patent Blue V (2a131) (Revocation) (Feed additive)

In consulting, the FSA is seeking views from stakeholders on the proposed revocation of the feed additive. Stakeholders are invited to use this opportunity to comment or highlight any additional factors that should be brought to the attention of ministers before the final decision is made.

Following the consultation, the next step is for the FSA to write to ministers in England and Wales with their recommendations. This is in line with FSA responsibility to provide advice, information or assistance to ministers in respect of matters connected with food safety or other interests of consumers in relation to food (section 6, Food Standards Act 1999). Ministers in Northern Ireland will be kept informed. Relevant ministers will then make decisions on the risk management recommendations, taking into account any relevant provisions of assimilated law and any other legitimate factors, including those raised during the consultation process.

7.2 Impacts

As part of the risk analysis and risk management process, the FSA has assessed the potential impacts that would result from the proposed revocation of authorisation.

The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (that is environmental, trade, political, environmental, societal, technical feasibility, and consumer interests).

For the proposed revocation of authorisation, which is the subject of this consultation, no significant impacts have been identified. Individual impacts, including trade, Northern Ireland, other legitimate factors, and others are listed in the risk management document.

7.3 Engagement and consultation process

Details of all applications for authorisation, and the authorisation status of previously authorised regulated products are published on the Register of Regulated Product Applications on the FSA website.

Stakeholders are invited to consider the questions posed below in relation to any relevant provisions of assimilated law and other legitimate factors.

Following the consultation process, responses will be made available on the FSA website and shared with ministers.

7.4 Questions

1. If you disagree with the FSA’s view or have particular concerns about the revocation of the authorisation of this feed additive, please explain why and provide information to help us understand and evidence the impact. 

2. Do the proposed transitional provisions allow enough time for feed businesses to use up existing stocks of this additive? 

3. Are there any other factors that should be considered by ministers that have not already been highlighted? 

4. Do you have any other feedback, including consideration of any relevant provisions of assimilated law and other legitimate factors (other evidence further supporting clear, rational and justifiable risk analysis, such as consumer interests, technical feasibility and environmental factors).

7.5 Responses

Responses are required by 23:59 on 02 October 2026.

If responding by email, please state whether you are responding as a private individual or on behalf of an organisation or company (including details of any stakeholders your organisation represents) and in which nation you are based.

Please respond via the online survey (opens in a new window). If this is not possible, email: RPconsultations@food.gov.uk

Please indicate which application or product you are responding about by using the following subject line:  Response to Patent Blue V consultation on the revocation of a feed additive.

We aim to publish a summary of responses to this consultation within around 3 months of the consultation closing.

For information on how the FSA handles your personal data, see the consultation privacy notice.

Responses will be shared with ministers in England, Wales and Northern Ireland.

7.6 Further information

If you require a more accessible format of this document, email RPconsultations@food.gov.uk and your request will be considered.

This consultation has been prepared in accordance with the HM Government Consultation Principles.

Thank you on behalf of the FSA for participating in this public consultation.

Regulated Products Service Delivery

8. Patent Blue V (2a131) (Revocation) (Feed additive)

8.1 Background

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) conducted a review of the safety of this feed additive due to a potential safety concern regarding aneugenicity, following concerns raised in a European Food Safety Authority (EFSA) opinion regarding this feed additive. 

The safety assessment could not conclude on the safety of this additive for the target species, due to being unable to conclude on potential aneugenicity concerns.

8.2 Trade 

A World Trade Organisation (WTO) notification would be expected under the SPS Agreement, as England and Wales are independently removing an additive from their respective markets. While the measure has trade‑restrictive effects in that it removes a product from circulation, it is justified on public health grounds, based on the underlying safety assessment, and is therefore permissible under WTO rules. Similar EU measures were notified to the WTO and attracted no comments.   

8.3 European Union (EU) 

Patent Blue V has not had its authorisation renewed in the EU. If this feed additive is revoked in England and Wales, then this will align with the EU. 

8.4 Northern Ireland 

Feed additives which are proposed to be placed on the Northern Ireland market are assessed by EFSA. If there is any difference in approach, this is managed through the relevant provisional Common Frameworks. If England and Wales were to revoke this authorisation this would align with the approach taken in the EU (and Northern Ireland).   

8.5 FSA Risk Management Recommendations 

The FSA and FSS safety assessment for Patent Blue V could not conclude that the feed additive is safe and does not have an adverse effect on the target population, at the intended concentrations of use. Therefore, the FSA recommend that the existing authorisation should be revoked. 

Transitional provisions should be implemented to allow time for existing stocks of this feed additive to be withdrawn from the market. 

Our recommendation is for a 3-month transitional period within which existing stocks of the additive and premixtures containing the additive, which are intended for non-food producing animals, can be used before being withdrawn from the market. 

Our recommendation is also for a 6-month transitional period within which feed materials and compound feed which have been produced with the additive or premixtures containing it, and which are intended for non-food producing animals, can be used before being withdrawn from the market. 

These transitional periods are proposed to run from the date that the authorisation is revoked in England and Wales. The products may continue to be lawfully produced in other UK nations.