Consultation on market authorisation of four regulated food products 15 December 2025: summary of responses

This page provides a summary of the consultation response, the main theme identified and the Food Standard Agency’s (FSA) response. We asked for stakeholders’ views, comments and feedback in relation to regulated product applications for four novel foods.  

The applications are: 

• RP1411 - Schizochytrium sp.oil rich in DHA and EPA (extension of use of the authorised novel food) 
• RP1476 - 2’-Fucosyllactose (produced by a derivative strain of Escherichia coli W (ATCC 9637)) 
• RP1477 - 3’-Sialyllactose (3’-SL) sodium salt (produced using a derivative strain of Escherichia coli W (ATCC 9637)) 
• RP1478 - 6’-Sialyllactose (6’-SL) sodium salt (produced using a derivative strain of Escherichia coli W (ATCC 9637)) 

We asked a wide range of people and organisations for their views. We also sent targeted information about the consultation to stakeholders with an interest in the regulated products.

We asked stakeholders to consider relevant areas of assimilated law and other factors, such as consumer interests, technical feasibility and environmental impact.

Consultation reach

The consultation had a wide reach, with automatic notifications sent to 3,823 UK-wide subscribers of FSA alerts at the time of launch, including FSA subscribers registered specifically to receive updates in relation to national content. This included: 

• 3256 subscribers to England
• 1892 subscribers to Northern Ireland
• 1976 subscribers to Wales

The FSA has a reach of 147,914 LinkedIn followers (as of 15 December 2025) and on LinkedIn the consultation had 4.1k impressions (the number of times a post appears in a user's feed) and 229 people engaged with the post.

The FSA consultation page received 1,103 page views and 884 visitors from 15 December 2025 to 08 February 2026.  

Food Standards Scotland (FSS) launched a consultation at the same time: Consultation on applications for authorisation of regulated products: Four novel foods. - Food Standards Scotland - Citizen Space 

The FSA is grateful to for those who engaged and responded. The response received is set out below.  

Characteristics of respondents 

The consultation response represents industry, and they reported as a UK-based international trade organisation.  

No responses were received by FSS in the parallel consultation.  

Summary of substantive comments

The response to the consultation has been analysed and the main theme identified. The FSA’s response to the comments is laid out on this page. 

Main theme of response 

Concerns over GB‑EU divergence under the anticipated SPS alignment. 

Summary of stakeholders’ comments 

The respondent supports allowing the three ingredients to be used in food supplements for infants and young children. They say no safety concerns have been identified for applications RP1476, RP1477 and RP1478.

However, they are concerned that Great Britain and the EU are being given different rules for the following three applications:

• RP1476 – 2'-Fucosyllactose (produced by a derivative strain of Escherichia coli W (ATCC 9637))
• RP1477 – 3'-Sialyllactose (3'-SL) sodium salt (produced using a derivative strain of Escherichia coli W (ATCC 9637))
• RP1478 – 6'-Sialyllactose (6'-SL) sodium salt (produced using a derivative strain of Escherichia coli W (ATCC 9637))

They are concerned that if the planned UK-EU SPS Agreement comes into force – expected around mid-2027 – EU novel food approvals would automatically apply in GB and override any different GB rules. This could mean businesses would need to reformulate and relabel products again, creating unnecessary cost and disruption.

The respondent believes the government should consider the upcoming SPS Agreement before authorising these substances.

FSA response 

We are working with the EU to implement the package agreed at the UK-EU summit and are committed to a broad and constructive relationship with the EU. We have begun negotiations with the EU on an SPS agreement to make agrifood trade with our biggest market cheaper and easier, cutting costs and removing barriers to trade for British producers and retailers. While negotiations are ongoing, we cannot comment further on potential outcomes.  

The Government’s manifesto is clear that an SPS agreement would remove barriers to trade, get rid of unnecessary paperwork and remove checks.  

The FSA already has a robust process for considering the impacts of divergence in our policy development process. This factors in potential consequences for GB-NI trade as well as GB-EU trade. The potential for an SPS agreement is an additional factor for us to consider.  

Whilst negotiations and any implementation etc of the agreement is ongoing, the FSA and ministers still have a legal obligation to progress applications and make determinations in line with the legislation that applies in GB which includes deadlines.  

We have considered details of the individual applications we received and have set out our reasoning for these GB authorisations. GB businesses may wish to be aware of the proposed SPS agreement discussions and the potential relevance to their products when considering whether to make use of these authorisations and the specific uses and food categories permitted.  

FSA is working across government and closely with industry to understand the impacts and challenges of an SPS Agreement. The FSA will, as always, work as transparently as possible with our stakeholders and will share further communications as soon as we can. 

Next steps 

The authorisation process requires ministers in England, Wales and Scotland to make decisions on the following: 

• an authorisation of 4 novel foods 

In Northern Ireland, the Health Minister will be informed of the recommendation to authorise. 

The FSA/FSS safety assessments on these applications concluded that the products are safe to be authorised based on their proposed terms of authorisation.  

There have been no further identified reasons to change the advice to ministers on the remaining applications during the consultation process. On that basis, the final FSA recommendation to ministers will be to authorise these applications on the proposed terms of authorisation outlined in the FSA Risk Management recommendations. Please be advised that the proposed terms of authorisation remain subject to modification until the official authorisation date.