Consultation on the Authorisation of 16 Regulated Products 2026
Consultation description
Launch date: 21 September 2026
Respond by: 16 November 2026
This page is also available in Welsh (Cymraeg)
The UK Government is currently negotiating a Sanitary and Phytosanitary (SPS) Agreement with the European Union (EU). Under the proposed Agreement, the UK would align with all EU legislation within the scope of the Agreement, including market authorisations (subject to any exceptions being agreed during the negotiations with the EU). Once the Agreement enters into force, rules applying in Great Britain (GB) would be updated in line with EU rules as they changed over time.
Products already authorised by the EU, and the conditions attached to those authorisations, would also apply in Great Britain (GB) once the Agreement enters into force. Existing GB authorisations would cease to apply. For further information Regulated products application guidance - GOV.UK
Please note, we have completed our risk assessment of the products that are the subject of this consultation for use in the food categories for which applicants sought authorisation for in Great Britain (GB). Our risk management proposals, as detailed in the proposed terms of authorisation for each application reflect this, and may differ from those currently authorised in the European Union (EU). If there is an agreement to dynamically align with EU authorisations, those ingredients will not be permitted in the food categories that are not included in the EU authorisation. Furthermore, where the authorised food categories are the same in GB and the EU, the EU authorisation conditions - including any maximum use levels and other risk management measures - would apply in place of the corresponding GB authorisation conditions.
This consultation will be of most interest to
All England, Wales, and Northern Ireland food businesses, local and port health authorities, district councils, and other stakeholders with an interest in food safety.
A parallel consultation [Insert Link] is being published by Food Standards Scotland (FSS).
Consultation subject
This consultation seeks stakeholders’ views, comments, and feedback in relation to the regulated product applications considered in this document, which have been submitted for:
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2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Escherichia coli K-12) (modification of use of authorised novel food)
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2’-Fucosyllactose/Difucosyllactose (2’-FL/DFL) mixture (produced by a derivative strain of Escherichia coli K-12 (DH1)) (modification of use of authorised novel food)
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2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Corynebacterium glutamicum (ATCC 13032)) as a novel food for use in food and food supplements (new authorisation of novel food)
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2’-Fucosyllactose(2’-FL) (produced by a derivative strain of Escherichia coli BL21(DE3)) (modification of use of authorised novel food)
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2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Escherichia Coli BL21 (DE3)) (modification of specification of authorised novel food)
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3′-Sialyllactose (3′-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)) (modification of use of authorised novel food)
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3’-Sialyllactose (3’-SL) sodium salt (produced by derivative strains of Escherichia coli BL21 (DE3)) as a novel food for use in food and food supplements (new authorisation of novel food)
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3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12) (MG1655)) as a novel food for use in food and food supplements (new authorisation of novel food)
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3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli BL21 (DE3)) as a novel food for use in food and food supplements (new authorisation of novel food)
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6’-Sialyllactose (6’-SL) sodium salt (produced by derivative strains of Escherichia coli BL21 (DE3)) as a novel food for use in food and food supplements (new authorisation of novel food)
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6′-Sialyllactose (6′-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)) (modification of specification of use of authorised novel food)
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Lacto-N-tetraose (LNT) (produced by a derivative strain of Escherichia coli K-12(DH1)) (modification of use of authorised novel food)
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Lacto-N-tetraose (LNT) (produced by derivative strains of Escherichia coli BL21 (DE3)) as a novel food for use in food and food supplements (new authorisation of novel food)
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Lacto-N-neotetraose (LNnT) (produced by a derivative strain of Escherichia coli K‑12) (modification of use of authorised novel food)
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Astaxanthin-rich oleoresin from Haematococcus pluvialis algae used as a Novel Food (Modification of specification and conditions of use)
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Schizochytrium sp. Oil Rich in DHA and EPA (modification of specification of authorised novel food)
Purpose of the consultation
The Food Standards Agency (FSA) is seeking views from stakeholders on the applications for authorisation referenced above, its risk management advice in respect of them, and the terms on which each one is proposed to be authorised. Stakeholders are invited to comment on the proposals, including in relation to labelling requirements or any other legitimate factors (i.e. social, environmental, economic etc) which may be relevant. Stakeholders are invited to use this opportunity to comment on these factors or highlight any additional factors that should be brought to the attention of ministers to inform their decision making.
Consultation pack
This consultation pack provides the background information, details and questions to which you are invited to respond. It provides links to the risk management recommendations and the safety assessments. The full consultation document is also accessible via the attachments further down this page.
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:
Email: RPconsultations@food.gov.uk
Name: Regulated Products Service Delivery
Division/Branch: Market Authorisations of Regulated Products
If responding by email, please state in your response whether you are responding as a private individual or on behalf of an organisation/company (including details of any stakeholders your organisation represents) and provide the nation in which you are based.
Publication of response summary
We aim to publish a summary of responses received around 3 months after the consultation ends and provide a link to it from this page. You can find information on how we handle data provided in response to consultations in our Consultations privacy notice.
Further information
If you require a more accessible format of this document, please send details to RPconsultations@food.gov.uk and your request will be considered.
This consultation has been prepared in accordance with HM Government Consultation Principles. The potential impacts in respect of our proposals are addressed in the consultation document. If no Impact Assessment has been provided, the reason will be given in the consultation document.
Thank you on behalf of the FSA for participating in this public consultation.
Regulated products service delivery