Consultation on applications for authorisation of regulated products: Sixteen novel foods

Overview

Consultation on applications for market authorisation: Sixteen novel foods

This consultation seeks stakeholders’ views, comments and feedback in relation to regulated product applications considered in this document.  

 

Who will this consultation be of most interest to?

This consultation will be of most interest to:

• All Scottish food businesses, local and district councils, and other stakeholders with an interest in food safety.

A list of interested parties is included in Annex A.

 

What is the purpose of this consultation?

This consultation is conducted by Food Standards Scotland (FSS) on behalf of the Cabinet Secretary for Economy Tourism and Transport and seeks stakeholders’ views, comments and feedback in relation to the market authorisation applications considered in this document.

 

The FSS opinions provided in the annexes to this document (including the proposed terms of authorisation) consider the FSS/FSA safety assessments. The views gathered through this consultation will be considered and included alongside those of officials across FSS and other Government Departments to inform Ministers’ decision-making on whether to authorise the individual market authorisations for use in Scotland.

 

The Food Standards Agency (FSA) have published a similar consultation for England and Wales.

 

FSS is responsible for providing the Cabinet Secretary with recommendations on the applications for the authorisation of market authorisations in respect of matters connected with food safety or other interests of consumers in relation to food (Section 3 of the Food (Scotland) Act 2015)

 

What is the subject of this consultation?

 

This consultation seeks stakeholders’ views, comments and feedback in relation to the  market authorisation applications included and referenced in this document. The consultation concerns 16 new market authorisations including both modifications to existing authorisations and new applications.

 

We ask stakeholders to consider any relevant provisions of law and other legitimate factors (other evidence further supporting clear, rational and justifiable risk analysis, such as consumer interests, technical feasibility and environmental factors), including those that FSS have identified as relevant to these applications. This is an opportunity for stakeholders to express views on these applications which Scottish Ministers will consider informing their decision making, which we consider crucial to the process of transparent policymaking.

 

Responses to this consultation

If you wish to comment on the applications in this consultation, all responses should be submitted through the Citizen Space entry, where the questions can be answered and other feedback given.

Contact details

LabellingStandardsandRegulatedProducts@fss.scot

 

Postal address

Food Standards Scotland

Fourth Floor

Pilgrim House

Old Ford Road

Aberdeen

AB11 5RL

 

Is a Business & Regulatory Impact Assessment (BRIA) included with this consultation?

No

 

 

 

 

 

1. Introduction

To be placed on the market in Scotland, applications for the authorisation of regulated products must be submitted to the Great Britain (GB) regulated products process. The decision on authorisation is made by the respective Minister in Scotland and England and Wales, with the Minister in Northern Ireland kept informed.

 

This is a function that was previously carried out at EU level.  Market authorisation applications for the GB market, detailed within this consultation are now subject to the UK’s own risk analysis process.

 

FSS has been working to ensure that the high standard of food safety and consumer protection in Scotland continues. This is in line with FSS responsibility to provide advice to Ministers in respect of matters connected with food safety or other interests of consumers in relation to food under section 3 of the Food (Scotland) Act 2015.

 

Under current operating arrangements for Northern Ireland, businesses seeking a new authorisation for a regulated food and feed product to be placed on the Northern Ireland market will continue to follow EU rules.

 

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

The applications within this consultation have each undergone a FSS safety assessment (arrived at in collaboration with FSA and meeting our obligation to carry out a risk assessment), including a full review of the dossiers and supplementary information provided by the applicants.

 

This consultation seeks to gather Scottish stakeholders’ views on the proposed regulated product applications for authorisations.

 

The provisional Food and Feed Safety and Hygiene 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 under the commitments to collaborative four-nation working set out in this Framework.

 

This consultation letter and the FSS accompanying Risk Management recommendations document present the opinions of FSS and any legitimate factors that FSS have identified as relevant to these applications, including the potential impact of any decision made by ministers. 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 before a final decision is made.

 

Following the consultation, Scottish ministers will decide on authorisation. They will consider the FSS recommendation, any relevant provisions of law and any other legitimate factors, including those raised during the consultation process.

 

2. Detail of Consultation

Novel foods

Novel foods are foods that were not used for human consumption to a significant degree within the UK or EU before 15 May 1997. In Scotland, the procedure for authorising the placing of new novel foods on the market, or to change the specifications or conditions of use of authorised novel foods, starts either on the initiative of the Ministers or following the submission of an application by an applicant in accordance with Regulation (EU) 2015/2283 on novel foods. The applications for authorisation of novel foods which are included in this consultation have been made under Article 10 of this Regulation, which outlines the procedure for authorising the placing on the market of novel foods and the updating of the public list. In accordance with Regulation (EU) 2015/2283, the novel food applications included in this consultation have been submitted for both new authorisations and modification of existing authorisations.

 

3. Terms of reference

Assimilated Law and EU Regulations

Directly applicable EU legislation no longer applies in GB. EU legislation, retained when the UK exited the EU, is called assimilated law with effect from 1 January 2024. References to any legislation with ‘EU’ or ‘EC’ in the title (e.g. Regulation (EU) 2015/2283 or Regulation (EC) 1333/2008) should now be regarded as assimilated law. Assimilated law is published on https://www.legislation.gov.uk.  

 

4. Food Supplements for Infants and Young Children

Several of the applications in this consultation request the authorisation of novel foods to be used as food supplements in food for infants and/or young children. Each of these applications have been subject to both FSS risk assessment and risk management procedures in order to ensure their safety and identify any issues there may be with placing them on the market under their proposed conditions of use. All applications, including those proposing the use of supplements in food for infants and/or young children, were considered safe under the proposed conditions of use. More information on the individual proposed authorisations can be found in the annexes below and in the accompanying Risk Management Recommendations document.

 

Article 9(3)(b) of assimilated Regulation (EU) 2015/2283 provides that an authorisation of a Novel Food should include additional specific labelling requirements where appropriate. In the case of the authorisations proposing the use of supplements in food for infants and/or young children, FSS proposes it is appropriate for additional labelling declaring that “The labelling of food supplements containing [the novel food product] intended for [infants and/or young children] must bear statement that they should not be consumed if breast milk or food with added [novel food product] are consumed on the same day” should form part of the Terms of Authorisation for the relevant authorisations.

 

Along with utilising our own expertise, FSS has worked alongside relevant Scottish Government teams for their expertise and interest in diet, supplements and child and infant health. This has allowed us to produce a consultation that has considered the potential implications of authorising the use of supplements in foods for infants and/or young children.

 

In general, food supplements are intended to supplement the normal diet, not replace it. They should be used alongside a varied, balanced diet that provides most of the nutrients your body needs. Relying on supplements instead of eating a wide range of foods is not recommended. You can find more information on food supplements here: Know the food facts: Food supplements | Food Standards Scotland.

 

5. UK Sanitary and Phytosanitary (SPS) Agreement 

As outlined in the UK-EU Summit Common Understanding, published on 19 May 2025, an SPS Agreement will involve dynamic alignment with EU law across areas in scope (including food safety and consumer protection rules), unless any exceptions based on specified criteria are agreed. 

 

Should we need to dynamically align with the relevant EU rules under an SPS Agreement, we anticipate relevant assimilated law, and those novel food authorisations which diverge with equivalent EU authorisations, would need to be amended or revoked at some point in the future. Should this scenario materialise, we expect that any action needed to align with the EU regulations in this respect will be swept up under the broader legislative work that will be needed to implement an SPS Agreement. 

 

6. Impacts

As part of the risk analysis process, FSS have assessed the potential impacts that may result should Ministers decide to authorise these market authorisations applications. Our assessment of the proposals did not identify any significant impacts. The impacts considered included those most frequently identified as potential impacts when introducing or amending food law (i.e. local authority delivery, health, environment, growth, innovation, trade, competition, consumer interests or small and micro-businesses).

 

Individual impacts, including trade, Northern Ireland and other legitimate factors for each application are listed in the corresponding Risk Management (RM) document for each application.

 

7. Other legitimate factors

In developing the risk management recommendations, FSS has had regard to the other legitimate factors (including consumer interests, political, environmental, societal and technical feasibility) that ministers typically consider as part of their decision on authorisation.  Stakeholders may wish to comment on any legislative, policy or public health considerations that they consider relevant to the proposed uses, including any implications for the wider framework relating to infant and young child nutrition and feeding. Stakeholders and the broader public are equally invited to consider and provide their views on any relevant other legitimate factors as part of the consultation process. 

 

8. Engagement and Consultation Process

Regulated Products

Details of all valid applications for regulated products are published monthly on the Register of Regulated Product Applications, available here.

 

Stakeholders are invited to consider the questions below.

 

Following the consultation process responses will be published and made available to stakeholders and ministers.

 

9. Questions asked in this consultation (for all applications)

1. Do you have any concerns about the safety of the applications with respect to the intended consumers?

 

2. Do you have any comments or concerns on the impacts of authorising or not authorising the applications and, if in favour of authorisation, the terms on which the applications are authorised (as outlined in the FSS Risk Management recommendations)?

 

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)?

 

5. In light of the other legitimate factors on public health considerations, do you have any comments on the implications of the proposed use of these products in food supplements for infants and/or young children? 

 

10. Responses

This consultation will run for 8 weeks. Responses are required by close of 24 November 2026.

Please state in your response via the questionnaire:

• Whether you are responding as a private individual or on behalf of an organisation/company (including details of any stakeholders your organisation represents).

 

• Which application(s)/product(s) you are commenting on.

 

• If you give us permission to quote your name or organisation in the publication of the results (please also make sure you have read and understood the paragraphs below where we discuss GDPR, publication of personal data and confidentiality of responses) or that of the organisation on whose behalf you are participating in the consultation in the publication of the results. For information on how FSS handles your personal data, please refer to the Consultation Privacy notice.

 

• Please indicate which application(s)/product(s) you are responding to by using the following subject line for your response: “Response to and the subject of the consultation.

 

• FSS aim to publish all responses to this consultation on Citizen Space within 3 months of the consultation closing. All responses should be sent through the Citizen Space entry for this consultation. Reponses will be shared with the FSA and ministers.

 

12.  Further information

If you require a more accessible format of this document, such as in Braille or in another language, please send details to the named contact for responses to this consultation and your request will be considered. Please let us know if you need paper copies of the consultation documents.

 

Please feel free to pass this document to any other interested parties or send us their full contact details and we will arrange for a copy to be sent to them direct.

 

This consultation has been prepared taking account of the Scottish Government guidance. For more information on consultations, please see Consultation in the Scottish Government: Guidance.

 

13. Queries

If you have any queries relating to this consultation, please contact FSS using the contact details on page 4, and an FSS official will be able to respond to your questions.

 

14. GDPR, publication of personal data and confidentiality of responses

The European General Data Protection Regulation (GDPR) replaces the Data Protection Directive 95/46/EC and was developed to harmonize data privacy laws across Europe. The Data Protection Act (DPA) 2018 applies GDPR standards and transposes the EU Data Protection Directive 2016/680 (Law Enforcement Directive) into domestic UK law.  In accordance with the GDPR, we are required to provide a privacy notice in relation to this public consultation. FSS will be known as the “Controller” of the personal data provided to us. We need to collect this information to allow us to effectively carry out our official duties of policy development and for the purposes of record keeping. In responding to this consultation, you have consented to provide this information to us but are able to withdraw your consent at any time by getting in touch with us.

 

Personal information will be stored on Scottish Government servers and cloud-based services have been procured and assessed against the national cyber security centre cloud security principles. Personal information will not be used for any purpose other than in relation to consultations. Personal information will be stored for as long as necessary to carry out the above functions and for five years from receipt in accordance with our retention policy. No third parties have access to your personal data unless the law allows them to do so.

 

You have a right to see the information we hold on you by making a request in writing to the email address below. If at any point you believe the information, we process on you is incorrect you can request to have it corrected. If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data not in accordance with the law, you can complain to the Information Commissioner’s Office (ICO). Our Data Protection Officer in the FSS is the Head of Corporate Services who can be contacted at the following email address: dataprotection@fss.scot. 

 

In accordance with the principle of openness, our office in Pilgrim House in Aberdeen will hold a copy of the completed consultation as per our retention policy. FSS will not publish anything without your consent. If you have any queries, please email: dataprotection@fss.scot or return by post to the address given on page 4.

In accordance with the provisions of Freedom of Information Act (Scotland) 2002/Environmental Information (Scotland) Regulations 2004, all information contained in your response may be subject to publication or disclosure. If you consider that some of the information provided in your response should not be disclosed, you should indicate the information concerned, request that it is not disclosed and explain what harm you consider would result from disclosure. The final decision on whether the information should be withheld rests with FSS. However, we will consider your views when making this decision. 

Any automatic confidentiality disclaimer generated by your IT system will not be considered as such a request unless you specifically include a request, with an explanation, in the main text of your response.

 

A detailed Privacy Policy is available on our website, that explains how FSS will safeguard and process any personal identifiable information that we collect from you in relation to this consultation.

 

15. Comments on the consultation process

We are interested in what you thought of this consultation and would therefore welcome your general feedback on both the consultation package and overall consultation process.  If you would like to help us improve the quality of future consultations, please feel free to share your thoughts with us by sending an email to openness@fss.scot or return by post to the address given on page 3.

 

Thank you on behalf of Food Standards Scotland for participating in this public consultation.

 

Regulated Products Team

Food Standards Scotland

LabellingStandardsandRegulatedProducts@fss.scot

16. List of Annexes

Details of the applications are given in the annexes below and in the FSS Risk Management recommendation documents which include the FSS opinions.

 

Annex A: List of interested parties

 

Annex B: Definitions – definitions which may be of use when responding to this consultation.

Annex C: RP1751 2’-Fucosyllactose (2'-FL) (produced by a derivative strain of Escherichia coli K-12 (DH1)) (modification of use of authorised novel food) 

Annex D: RP1753 - 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) 

Annex E: RP2119 - 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) 

 

Annex F: RP2155 - 2’-Fucosyllactose (2’-FL) produced by a derivative strain of Escherichia coli BL21 (DE3) (modification of use of authorised novel food)  

 

Annex G: RP2257 - 2’-Fucosyllactose (2’-FL) produced by a derivative strain of Escherichia Coli BL21 (DE3) (modification of specification of authorised novel food)  

 

Annex H: RP1755 - 3′-Sialyllactose (3′-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)) (modification of use of authorised novel food)  

 

Annex I: RP2121 - 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)  

 

Annex J: RP2001- 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)  

 

Annex K: RP2106 - 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)  

 

Annex L: RP2114 - 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)  

 

Annex M: RP1754 - 6′-Sialyllactose (6′-SL) sodium salt  (produced by a derivative strain of Escherichia coli K-12 (DH1)), (modification of use of authorised novel food)  

Annex N: RP1750- Lacto-N-tetraose (LNT) (produced by a derivative strain of Escherichia coli K-12(DH1)) (modification of use of authorised novel food) 

 

Annex O: RP2101 - 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)  

 

Annex P: RP1752 - Lacto-N-neotetraose (LNnT) (produced by a derivative strain of Escherichia coli K‑12 (DH1)) (modification of use of authorised novel food). 

 

Annex Q: RP2213 - Astaxanthin-rich Oleoresin from Haematococcus ⁠pluvialis Algae used as a novel food (modification of specification and conditions of use) 

 

Annex R: RP2180 -  Schizochytrium sp. Oil Rich in DHA and EPA (modification of specification of authorised novel food) 

 

 

17. Annex A: List of interested parties

Key stakeholder trade associations who have an interest in food and feed across the wider sector will be contacted directly for feedback on this consultation:  

 

Specialist Nutrition Association  

British Nutrition Foundation  

British Retail Consortium (BRC)

Chilled Food Association (CFA)  

Food and Drink Federation FDF (Scotland)

British Dietetic Association

Food and Drink Federation FDF Sector Group: Food additives

Kantar Media

Kantar Worldpanel

UK Flavour Association (UKFA)

Food Additives & Ingredients Association (FAIA)

Federation of Bakers

Health Food Manufacturers’ Association  

Campden BRI  

Council for Responsible Nutrition UK

Scottish Retail Consortium 

International Organization of the Flavour Industry (IOFI)

Which

This is not an exhaustive list.

 

Return to top of consultation document.

 

18. Annex B: Definitions

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

 

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.

 

Novel foods are foods that were not used for human consumption to a significant degree within the UK or EU before 15 May 1997. In order to place new novel foods on the GB market or to change the specifications or conditions of use of authorised novel foods, applicants must submit an application in accordance with Regulation 2015/2283.

Novel foods authorisation guidance

 

Assimilated Regulations - Directly applicable EU legislation no longer applies in GB. EU legislation, retained when the UK exited the EU, was assimilated   with effect from 1 January 2024 References to any legislation with ‘EU’ or ‘EC’ in the title should now be regarded as assimilated law where applicable to GB. Assimilated law is published on legislation gov.uk.

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 under the commitments to collaborative four-nation working set out in this Framework. As such, this consultation has been developed through a four-nation approach. Final recommendations will be agreed on a three-nation basis before being presented to ministers in England, Scotland 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.

 

Windsor Framework - For pre-packaged retail agrifood goods eligible for Northern Ireland Retail Movement Scheme (NIRMS):

 

• • In October 2023, the Windsor Framework was implemented providing a unique set of arrangements to support the flow of pre-packaged agrifood retail food products for final consumption 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)

 

• • Under the Northern Ireland Retail Movement Scheme, regulated products which have been authorised in Great Britain, will be able to be placed on the market in Northern Ireland if they meet these criteria.

 

• • The FSS remain committed to ensuring that consumers across the Scotland can be confident that food is safe and is what it says it is, even where rules applicable to the same type of food may be slightly different.

 

Safety Assessment - 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. Links to the safety assessment for each application can be found in the relevant corresponding Annex below.

 

Risk Management - Our policy advisors are responsible for the Risk Management outputs. FSS Risk Management recommendations document presents the factors 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. Links to the Risk Management recommendations document for each application can be found in the relevant corresponding Annex below.

 

Food Supplements for Infants and/or Young Children – Food supplements are defined by the Food Supplements (Scotland) Regulations 2003 as “any food the purpose of which is to supplement the normal diet and which (a) is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination; and (b) is sold in dose form”, while Regulation (EU) 609/2013 on food intended for infants and young children (etc.) defines an ‘infant’ as “a child under the age of 12 months” and a ‘young child’ as “a child aged between on three years”.

 

 Return to top of consultation document.

Annex C: RP1751 - 2’-Fucosyllactose (2’FL) (produced by a derivative strain of Escherichia coli K12 (DH1)) (modification of use of authorised novel food)

 

19. Background 

An application was received from Glycom A/S, Belgium for the proposed modification of the conditions of use of 2'-Fucosyllactose (2'-FL) (produced by a derivative strain of Escherichia coli K-12 (DH1)), to permit its use in the additional food category of food supplements for infants. It also seeks to remove the condition of use referring to the ratio of 2'-FL to the human-identical milk oligosaccharide (HiMO) lacto-N-neotetraose (LNnT). 

Although the application was framed as a modification of the conditions of use of 2'-Fucosyllactose (2'-FL) (produced by a derivative strain of Escherichia coli K-12 (DH1)), the production-strain-specific specification referred to in the application forms part of the existing authorisation for 2'-Fucosyllactose (2’FL) and is not currently authorised as a separate novel food in its own right. To give effect to the application, the proposed authorisation would modify the existing authorisation for 2'-Fucosyllactose (2’FL) in relation to the specification produced by a derivative strain of Escherichia coli K-12 (DH1) and authorise a new novel food, 2'-Fucosyllactose (2'-FL) (produced by a derivative strain of Escherichia coli K-12 (DH1)), with a separate specification corresponding to that production strain. No substantive changes are proposed to the specification itself.  

The proposed new authorisation would permit use of the novel food in food supplements for infants and would reflect the removal of the provision relating to the ratio with LNnT 

For new novel foods and modifications of use to authorised novel foods to be placed on the GB market , an application shall be submitted in accordance with assimilated EU Regulation 2015/2283. 

 

20. Trade 

Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs. 

21. European Union (EU) 

Please see information outlined at the start of this document regarding the proposed SPS Agreement with the EU. 

2’-Fucosyllactose (produced by a derivative strain of Escherichia coli K-12 (DH1)) is already approved for use in the EU. The original authorisation and subsequent modifications of use for this product are currently identical in the EU and GB. The proposed modification to allow use in infant supplements will diverge from the EU’s authorisation.       

 

22. Northern Ireland 

This novel food is already authorised in Northern Ireland.  FSS recommendation to authorise for use in food supplements for infants will lead to some divergence. If approved in Scotland, this novel food will be able to be placed on the market in Northern Ireland if eligible for and moved through Northern Ireland Retail Movement Scheme.  

Scottish authorisation alone does not permit the novel food to be placed on the Northern Ireland market as an ingredient or for onward manufacture. 

 

23. FSS RM Recommendations 

The FSS risk management recommendation is the modification of specification of use of 2’-Fucosyllactose (2'-FL) (produced by a derivative strain of Escherichia coli K-12 (DH1)), an approved novel food, as described in this application, is safe and is not liable to have an adverse effect on the target population (infants), environmental safety and human health at the intended conditions of use.  

 

Safety Assessment Summary

 

The European Food Safety Authority (EFSA)’s 2015 assessment (Safety of 2′‐O‐fucosyllactose as a novel food ingredient pursuant to Regulation (EC) No 258/97 - - 2015 - EFSA Journal - Wiley Online Library found 2’- Fucosyllactose (2’-FL) to be safe at proposed use levels, including in infant formula, foods and supplements, with no identified safety concerns.  Under Regulation (EU) 2015/2283 (Regulation (EU) 2015/2283), FSS risk assessors reviewed the available evidence to determine whether further evaluation was needed. Although the original EFSA assessment did not specifically assess use in food supplements for infants, FSS risk assessors concluded that its safety findings were applicable to the proposed use because infant exposure from supplements at the proposed levels would be comparable to exposure levels previously assessed and to levels naturally occurring in breast milk. Consequently, no further safety assessment was considered necessary. No adverse effects have been identified; based on the evidence in the original assessment, the additional uses are not expected to pose a risk to human health.

 

Annex D: RP1753 - 2’Fucosyllactose/Difucosyllactose (2’-FL/DFL) mixture (produced by a derivative strain of Escherichia coli K12 (DH1))(modification of use of authorised novel food)

 

24. Background 

An application was received from Glycom A/S, Belgium for the proposed modification of the conditions of use of 2’-Fucosyllactose/Difucosyllactose (2’-FL/DFL) mixture (produced by a derivative strain of Escherichia coli K-12 (DH1)), to permit its use in the additional food category of food supplements for infants at a maximum level for infants under 6 months old and a separate level for infants between 6 months and 12 months old.  

Although the application was framed as a modification of the conditions of use of 2’-Fucosyllactose/Difucosyllactose (2’-FL/DFL) mixture (produced by a derivative strain of Escherichia coli K-12 (DH1)), the production-strain-specific specification referred to in the application forms part of the existing authorisation for 2'Fucosyllactose/Difucosyllactose mixture (‘2'-FL/DFL’)(microbial source) and is not currently authorised as a separate novel food in its own right. To give effect to the application, the proposed authorisation would modify the existing authorisation for 2'-Fucosyllactose/Difucosyllactose mixture (‘2'-FL/DFL’)(microbial source) in relation to the specification produced by a derivative strain of Escherichia coli K-12 (DH1) and authorise a new novel food, 2’-Fucosyllactose/Difucosyllactose (2’-FL/DFL) mixture (produced by a derivative strain of Escherichia coli K-12 (DH1)), with a separate specification corresponding to that production strain. No substantive changes are proposed to the specification itself.  

The proposed new authorisation would permit use of that novel food in food supplements for infants as sought in the application. 

For new novel foods and modifications of use to authorised novel foods to be placed on the market in GB, an application shall be submitted in accordance with assimilated EU Regulation 2015/2283. 

25. Trade 

Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs. 

 

 

26. European Union (EU) 

Please see information outlined at the start of this document regarding the proposed SPS Agreement with the EU.  

2’-Fucosyllactose/Difucosyllactose (2’-FL/DFL) mixture (produced by a derivative strain of Escherichia coli K-12(DH1)) is already approved for use in the EU. The original authorisation and subsequent modifications of use for this product are currently identical in the EU and GB.  The modification proposed in this consultation to allow use in food supplements for infants will diverge from the EU’s authorisation. This divergence will also be reflected in the labelling of supplements. In the EU food supplements for any age must be labelled with a statement that they should not be used if breast milk or other food containing added 2’-Fucosyllactose/Difucosyllactose mixture is consumed the same day. The proposed amendment in Scotland will only require the statement to refer to infants and young children and children under 10.  

 

27. Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSS recommendation to authorise for use in food supplements for infants will lead to some divergence in the conditions of use and labelling. If approved in Scotland, this novel food will be able to be placed on the market in Northern Ireland if eligible for and moved through Northern Ireland Retail Movement Scheme.   

GB authorisation alone does not permit the novel food to be placed on the Northern Ireland market as an ingredient or for onward manufacture   

 

28. FSS RM Recommendations 

The FSS risk management recommendation is that the conditions of use of 2’-Fucosyllactose/Difucosyllactose (2’-FL/DFL) mixture (produced by a derivative strain of Escherichia coli K-12 (DH1)), an approved novel food, as described in this application, are safe and are not liable to have an adverse effect on the target population (infants), environmental safety and human health.

 

Safety Assessment Summary

 

EFSA’s 2019 assessment (Safety of 2’‐fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283 - - 2019 - EFSA Journal - Wiley Online Library) found 2’-FL DFL to be safe at proposed use levels, including in infant formula, foods and food supplements, with no identified safety concerns.  Under Regulation (EU) 2015/2283 (Regulation (EU) 2015/2283), FSS risk assessors reviewed the available evidence (consistent with EFSA review (Safety of the extension of use of 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture and lacto‐N‐tetraose (LNT) as novel foods in food supplements for infants pursuant to Regulation (EU) 2015/2283 - - 2022 - EFSA Journal - Wiley Online Library) to determine whether further evaluation was needed. Although the original EFSA assessment did not specifically assess use in food supplements for infants, a subsequent EFA opinion assessed the proposed uses. FSS risk assessors concluded that the safety findings were applicable to the proposed use because infant exposure from supplements at the proposed levels would be comparable to exposure levels previously assessed and to levels naturally occurring in breast milk. Consequently, no further safety assessment was considered necessary. No adverse effects have been identified; based on the evidence in the original assessment, the additional uses are not expected to pose a risk to human health.  

 

Annex E: RP2119 - 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) 

 

29. Background 

An application was received from Advanced Protein Technologies Corp for the proposed authorisation of 2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Corynebacterium glutamicum (ATCC 13032)) as a novel food.   

This application is seeking to use the novel food within the following categories: dairy products and analogues, bread and pasta products, table-top sweeteners, foods for specific groups (infants and young children) and uses (total diet replacement for weight loss, special medical purpose), beverages, and food supplements (excluding supplements for infants). 

For new novel foods and modifications of use to authorised novel foods to be placed on the market in GB, an application shall be submitted in accordance with assimilated EU Regulation 2015/2283. 

 

30. Trade 

Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs. 

 

31. European Union (EU) 

Please see information outlined at the start of this document regarding the proposed SPS Agreement with the EU.  

2’-Fucosyllactose (2’-FL) has been authorised in the EU where it is authorised to be produced by a derivative strain of Corynebacterium glutamicum (ATCC 13032)). The food categories and intended use levels within this application are the same as those currently in the EU List of Novel Foods, with the exception that the maximum levels for infant formula and follow-on formula are higher in the EU than those proposed as part of this authorisation. This application outlines the same labelling requirements and the same name of the product as currently authorised within the EU. No divergence is expected with labelling requirements. 

 

32. Northern Ireland 

This novel food is already authorised in Northern Ireland. FSS’s recommendation to authorise 2’-Fucosyllactose (2'-FL) (produced by a derivative strain of Corynebacterium glutamicum (ATCC 13032)) for use at specific maximum levels in infant formula and follow-on formula will lead to some divergence. If approved in Scotland, this novel food will be able to be placed on the market in Northern Ireland if eligible for, and moved through, the Northern Ireland Retail Movement Scheme.

 

GB authorisation alone does not permit the novel food to be placed on the Northern Ireland market as an ingredient or for onward manufacture

 

33. FSS RM Recommendations

The FSS risk management recommendation is that 2’-Fucosyllactose (produced using a derivative strain of Corynebacterium glutamicum (ATCC 13032)), as described in the application, is safe and is not liable to have an adverse effect on the target population ( infants, young children, and adults to include lactating women and pregnant women) environmental safety and human health at the intended levels of use. 

The FSS risk management recommendations and safety assessment can be found below:  

FSS safety assessment: Assessment on 2’-Fucosyllactose (2’-FL) Derived From Genetically Modified Corynebacterium Glutamicum APC199 as a Novel Food for Use in Food and Food Supplements (RP2119) | Published in FSA Research and Evidence

 

Annex F:  RP2155 - 2’-Fucosyllactose (2’-FL) produced by a derivative strain of Escherichia coli BL21 (DE3) (modification of use of authorised novel food)

 

34. Background 

An application was received from Chr. Hansen A/S, Denmark for the modification of the conditions of use of the authorised novel food, 2’-Fucosyllactose (2’-FL) produced by a derivative strain of Escherichia coli BL21 (DE3).

  

This application requests the modification of the maximum use levels for infant formula and infant follow-on formula from 1.2 g/l (in the final product ready to use) to 3 g/l (in the final product ready to use) and 3.64 g/l (in the final product ready to use), respectively. Further, the application seeks to remove the clause from the relevant conditions of use referencing the combination with human-identical milk oligosaccharide (HiMO) Lacto-N-neotetraose (LNnT).   

 

Although the application was framed as a modification of the conditions of use of 2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Escherichia coli BL21 (DE3)) , the production-strain-specific specification referred to in the application forms part of the existing authorisation for 2’-Fucosyllactose and is not currently authorised as a separate novel food in its own right. To give effect to the application, the proposed authorisation would modify the existing authorisation for 2’-Fucosyllactose in relation to the specification produced by a derivative strain of Escherichia coli BL21 (DE3) and authorise a new novel food, 2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Escherichia coli BL21(DE3)), with a separate specification corresponding to that production strain. There are some proposed changes to the specification in the separate application RP2257 (see Annex G). 

 

For new novel foods and modifications of use to authorised novel foods to be placed on the market in GB, an application shall be submitted in accordance with assimilated EU Regulation 2015/2283. 

35. Trade 

Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs. 

 

36. European Union (EU) 

Please see information outlined at the start of this document regarding the proposed SPS Agreement with the EU.  

 

The proposed uses and use levels are the same as those already set out in the EU list of authorised novel foods, and this source of 2’-Fucosyllactose (2’-FL) is already approved in the EU. The EU has since increased the permitted levels in infant and follow-on formula. If approved, this application would align the Scottish authorisations with those updated EU levels. 

 

37. Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSS’s recommendation to authorise 2’-Fucosyllactose (2'-FL) (produced by a derivative strain of Escherichia coli BL21(DE3)) will align with Northern Ireland. If approved in Scotland to use this production strain, will be able to be placed on the market in Northern Ireland if eligible for, and moved through Northern Ireland Retail Movement Scheme.  

GB authorisation alone does not permit the novel food to be placed on the Northern Ireland market as an ingredient or for onward manufacture  

 

38. FSS RM Recommendations 

The FSS risk management recommendation is the modification of use of 2’-Fucosyllactose (2’-FL) produced by a derivative strain of Escherichia coli BL21 (DE3), an approved novel food, as described in this application, is safe and is not liable to have an adverse effect on the target population (infants and young children)environmental safety and human health under the intended conditions of use. 

 

The FSS risk management recommendations and safety assessment can be found below:  

FSS safety assessment: Assessment of Novel Food 2’-Fucosyllactose (2’-FL) for a Change to the Conditions of Use as a Food Ingredient (RP2155) | Published in FSA Research and Evidence 

 

Annex G:  RP2257 - 2’-Fucosyllactose (2’-FL) produced by a derivative strain of Escherichia Coli BL21 (DE3)) (modification of specification of authorised novel food)

 

39. Background 

An application was received from Chr. Hansen A/S, Denmark for the modification of the specifications of the authorised novel food, 2’-Fucosyllactose (2’-FL) produced by a derivative strain of Escherichia coli BL21 (DE3)). 

 

This application requests an increase in the permitted endotoxin limits from ≤0.1 EU/mg to ≤10 EU/mg in powder form and from ≤0.1 EU/µL to ≤10 EU/µL in liquid form. The proposed changes do not alter the safety considerations supporting the original authorisation and are intended to align the specifications with other authorised 2’-FL products. 

 

Although the application was framed as a modification of the specification for 2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Escherichia coli BL21 (DE3)) as described in the application, the production-strain-specific specification referred to in the application forms part of the existing authorisation for 2’-Fucosyllactose and is not currently authorised as a separate novel food in its own right. To give effect to the application, the proposed authorisation would modify the existing authorisation for 2’-Fucosyllactose in relation to the specification produced by a derivative strain of Escherichia coli BL21 (DE3)) and authorise a new novel food, 2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Escherichia coli BL21), with a separate specification corresponding to that production strain. This has also been explained in connection with RP2155 (see Annex F) which is a proposal to modify the conditions of use for the same novel food. 

 

For new novel foods and modifications to authorised novel foods to be placed on the market in GB, an application shall be submitted in accordance with assimilated EU Regulation 2015/2283. 

 

40. Trade 

Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs. 

 

41. European Union (EU) 

Please see information outlined earlier in this document regarding the proposed SPS Agreement with the EU.  

 

The proposed uses and use levels are the same as those set out in the EU list of authorised novel foods, and this source of 2’-Fucosyllactose (2’-FL) is already authorised in the EU. The EU has also updated the specification for this product under Implementing Regulation (EU) 2024/2102. If approved, this application would align the GB authorisation with the updated EU specification.

 

42. Northern Ireland 

Under the Windsor Framework, 2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Escherichia Coli BL21(DE3)) using the requested modification. If approved in Scotland, this novel food will be able to be placed on the market in Northern Ireland if eligible for and moved through Northern Ireland Retail Movement Scheme.   

GB authorisation alone does not permit the novel food to be placed on the Northern Ireland market as an ingredient or for onward manufacture. 

 

43. FSS RM Recommendations 

The FSS risk management recommendation is the modification of specification of 2’-Fucosyllactose (2’-FL) produced by a derivative strain of Escherichia Coli BL21 (DE3), an approved novel food, as described in this application, is safe and is not liable to have an adverse effect on the target population (infants and young children), environmental safety and human health under the intended conditions of use. 

 

The FSS risk management recommendations and safety assessment can be found below:  

FSS safety assessment: Assessment of a Modification of Specifications of 2’-Fucosyllactose (2’-FL) Produced by a Genetically Modified Strain of Escherichia Coli BL21 (RP2257) | Published in FSA Research and Evidence 

 

Annex H:  RP1755 - 3′-Sialyllactose (3′-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)) (modification of use of authorised novel food)

 

44. Background 

An application was received from Glycom A/S, Belgium for the proposed modification of the conditions of use of 3’-Sialyllactose (3’-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)), to permit its use in the additional food categories of food supplements for infants and young children.  

 

Although the application was framed as a modification of the conditions of use of 3’-Sialyllactose (3’-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)), the production-strain-specific specification referred to in the application forms part of the existing authorisation for 3’-Sialyllactose (3’-SL) sodium salt (microbial source) and is not currently authorised as a separate novel food in its own right. To give effect to the application, the proposed authorisation would modify the existing authorisation for 3’-Sialyllactose (3’-SL) sodium salt (microbial source) in relation to the specification produced by a derivative strain of Escherichia coli K-12 (DH1))  and authorise a new novel food, 3’-Sialyllactose (3’-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)), with a separate specification corresponding to that production strain. No substantive changes are proposed to the specification itself.  

 

The proposed new authorisation would permit use of that novel food in additional food categories as sought in the application.  

 

For new novel foods and modifications of use to authorised novel foods to be placed on the market in GB, an application shall be submitted in accordance with assimilated EU Regulation 2015/2283. 

 

45. Trade 

Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs. 

 

46. European Union (EU) 

 

Please see information outlined at the start of this document regarding the proposed SPS Agreement with the EU.

 

3’-Sialyllactose (3’-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)) is already approved for use in the EU. The EU has not authorised the novel food for use in food supplements for infants and young children. If authorised, this will mean there is divergence between GB and the EU in the uses authorised for this novel food. Apart from use in food supplements for infants and young children, the food categories and intended use levels within this application align with those listed in the EU List of Novel Foods under Commission Implementing regulation - 2017/2470 - EN - EUR-Lex. 

 

47. Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSS recommendation to authorise for use in food supplements for infants and young children will lead to some divergence.

If approved in Scotland, this novel food will be able to be placed on the market in Northern Ireland if eligible for and moved through Northern Ireland Retail Movement Scheme.   

GB authorisation alone does not permit the novel food to be placed on the Northern Ireland market as an ingredient or for onward manufacture 

 

48. FSS RM Recommendations 

 

The FSS risk management recommendation is the conditions of use of 3′-Sialyllactose (3′-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)), an approved novel food, as described in this application, is safe and is not liable to have an adverse effect on the target population (infants and young children), environmental safety and human health.

 

The FSS risk management recommendations and safety assessment can be found below:  

 

The EFSA assessment found 3’-Sialyllactose (3’-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)) to be safe at proposed use levels, including in infant formula, foods and supplements, with no identified safety concerns.  Under Regulation (EU) 2015/2283, FSA risk assessors reviewed the available evidence to determine whether further evaluation was needed. The additional uses requested were assessed by the original safety assessment and therefore do not require further assessment. No adverse effects have been identified; based on the evidence in the original assessment, the additional uses are not expected to pose a risk to human health.  

 

EFSA’s assessment: Safety of 3’‐Sialyllactose (3’‐SL) sodium salt as a novel food pursuant to Regulation (EU) 2015/2283 - - 2020 - EFSA Journal - Wiley Online Library  

 

Annex I:  RP2121 - 3′-Sialyllactose (3′-SL) sodium salt (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) 

 

49. Background      

An application was received from Chr. Hansen A/S  for authorisation of a novel food consisting of 3’-Sialyllactose (3’-SL) sodium salt, produced by derivative strains of  Escherichia coli BL21 (DE3).

 

For new novel foods and modifications of use to authorised novel foods to be placed on the market in GB, an application shall be submitted in accordance with assimilated EU Regulation 2015/2283. 

 

50. Trade 

Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs. 

 

51. European Union (EU)  

Please see information outlined at the start of this document regarding the proposed SPS Agreement with the EU.

 

The current GB application (RP2121) and the EU authorisation for 3’-Sialyllactose (3’-SL) sodium salt differ in conditions of use for certain groups. In the EU, specific maximum levels are currently set for foods for special medical purposes (FSMP), and food supplements exclude infants and young children. In contrast, the GB application combines FSMP categories with no specified maximum level and includes food supplements for infants and young children at defined levels. If authorised, these differences would result in divergence between GB and the EU conditions of use of this novel food. A further difference has been identified in the product specifications. The EU authorisation currently refers to Cronobacter (Enterobacter) sakazakii, whereas the proposed GB authorisation refer to Cronobacter spp.. The proposed GB wording aligns with the safety assessment. 

If authorised, this would result in a difference between the GB and EU specifications. 

 

52. Northern Ireland 

Under the Windsor Framework, a novel food such as “3’- Sialyllactose (3’-SL) sodium salt (produced by derivative strains of Escherichia coli E. coli BL21(DE3))

if approved in Scotland to use this production strain, will be able to be placed on the market in Northern Ireland if eligible for, and moved through Northern Ireland Retail Movement Scheme.  

GB authorisation alone does not permit the novel food to be placed on the Northern Ireland market as an ingredient or for onward manufacture 

 

This novel food is already authorised in Northern Ireland, under the same conditions as in the EU (see section above). If authorised, these differences would result in divergence between GB and the EU conditions of use of this novel food. A further difference has been identified in the product specifications. The EU authorisation currently refers to Cronobacter (Enterobacter) sakazakii, whereas the proposed GB authorisation refer to Cronobacter spp. The proposed GB wording aligns with the safety assessment. 

 

53. FSS Risk Management Recommendations 

 

The FSS risk management recommendation is that the novel food, 3’-Sialyllactose (3’-SL) sodium salt (produced by a derivative strain of Escherichia coli BL21 (DE3)), as described in this application, is safe and is not liable to have an adverse effect on the target population (infants, young children and adults to include lactating and pregnant women), environmental safety and human health under the intended conditions of use. 

 

The FSS risk management recommendations and safety assessment can be found below:  

 

FSS safety assessment: Safety Assessment of 3’-Sialyllactose (3’-SL) Sodium Salt Used as a Novel Food in Food and Food Supplements (RP2121) | Published in FSA Research and Evidence 

 

Annex J: RP2001- 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

 

54. Background 

An application for the authorisation of 3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 (MG1655)) was received by Inbiose N.V., Belgium.  

 

The applicant proposes the authorisation of 3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 (MG1655)) for use in food supplements and in thirteen food categories including dairy products and analogues, cereals, bread and pasta products, foods for special groups and beverages. 

 

For new novel foods and modifications of use to authorised novel foods to be placed on the market in GB, an application shall be submitted in accordance with assimilated EU Regulation 2015/2283.

 

55. Trade 

Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs.

 

56. European Union (EU) 

 

Please see information outlined at the start of this document regarding the proposed SPS Agreement with the EU.  

 

The applicant made an equivalent application in the EU which was authorised in 2021 however the terms of authorisation currently differ between the EU and proposed GB terms of authorisation.  

There are three areas of divergence in the proposed terms of authorisation: 

• There is a currently a difference in permitted maximum levels for eight food categories, which in all cases of divergence are higher in the proposed GB terms of authorisation.  

• The inclusion of the food category “Breakfast Cereals, Ready to eat” which is not explicitly included in the EU authorisation.  

• The GB proposal requests the use of the novel food in food supplements for young children. 

 

There are currently two areas of divergence in the specification: 

• In GB the applicant requested criteria for Salmonella app at “Absent in 100g” and for Cronobacter sakazakii for “Absent in 100g” whereas in the EU the respective levels are “Absence in 25g” and “Absence in 10g”. 

• The EU authorisation currently includes the term “residual” before “water”. 

 

Authorisation will mean there is divergence between GB and the EU in the uses authorised for this Novel Food. Because of this, labelling requirements for the product will diverge (although the designated name of the product, will not differ between the EU and GB). 

 

57. Northern Ireland 

 

Under the Windsor Framework, a novel food such as 3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 (MG1655)) authorised in Scotland to use this production strain, will be able to be placed on the market in Northern Ireland if eligible for, and moved through Northern Ireland Retail Movement Scheme.  

GB authorisation alone does not permit the novel food to be placed on the Northern Ireland market as an ingredient or for onward manufacture  

 

Allowing the use of food supplements for young children will lead to divergence within Northern Ireland, as the current EU authorisation only allows 3-FL in products for those over three years old. 

 

If placed on the market the terms of authorisation for use of the product will also lead to divergence within Northern Ireland, due to the higher maximum levels permitted in some food categories in the proposed GB authorisation.

 

58. FSS RM Recommendations 

 

The FSS risk management recommendation is that 3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 (MG1655)), as described in this application, is safe and is not liable to have an adverse effect on the target population, environmental safety and human health at the intended levels of use. 

 

The FSS risk management recommendations and safety assessment can be found below:  

 

FSS safety assessment: Safety Assessment of 3-Fucosyllactose (3-FL) as a Novel Food for Use in Food and Food Supplements (RP2001) | Published in FSA Research and Evidence 

 

Annex K:  RP2106 - 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)

 

59. Background 

An application for the authorisation of 3‑Fucosyllactose (3‑FL) (produced by a derivative strain of Escherichia coli (BL21 (DE3)) was received for authorisation in GB from Chr. Hansen A/S, Denmark. 

The applicant proposes the authorisation of this 3‑Fucosyllactose (3‑FL) for use as a human‑identical milk oligosaccharide in foods, including infant formula and food

supplements. 

For new novel foods and modifications of use to authorised novel foods to be placed on the market in GB, an application shall be submitted in accordance with assimilated EU Regulation 2015/2283. 

 

60. Trade 

Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs. 

 

61. European Union (EU) 

 

Please see information outlined at the start of this document regarding the proposed SPS Agreement with the EU.

 

In the EU, a similar application to RP2106 was authorised under Implementing Regulation (EU) 2023/52 and later amended by Implementing Regulation (EU) 2025/1537 to increase maximum use levels across several food categories. No corresponding application has yet been submitted in GB to align with these updated EU levels. Compared to the current EU authorisation, the GB application (RP2106) proposes lower maximum use levels for infant formula, follow-on formula and food supplements. In addition, the GB approach does not specify numerical limits for foods for special medical purposes (FSMP), instead allowing use in line with the nutritional requirements of the target population. The absence of explicit maximum levels for FSMP in GB reflects a different risk management approach rather than a difference in safety conclusions, as both the current EFSA assessment and the FSS/FSA assessments support safe use without the need for fixed numerical limits. Consequently, authorisation of this application would result in divergence between GB and EU conditions of use.

 

62. Northern Ireland 

Under the Windsor Framework, a novel food authorised in GB may only be placed on the Northern Ireland market in limited circumstances, such as within qualifying NI retail products under the Northern Ireland Retail Movement Scheme.

 

This novel food is already authorised in Northern Ireland. The FSS recommendation to authorise for use in food supplements for infants, lower maximum use levels, and the absence of fixed limits for foods for special medical purposes will lead to some divergence. If approved in Scotland, this novel food will be able to be placed on the market in Northern Ireland if eligible for and moved through Northern Ireland Retail Movement Scheme.  

 

GB authorisation alone does not permit the novel food to be placed on the Northern Ireland market as an ingredient or for onward manufacture. 

 

63. FSS RM Recommendations 

 

The FSS risk management recommendation is the authorisation of the novel food 3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli (BL21 (DE3)), as described in this application, is safe and is not liable to have an adverse effect on the target population (infants, young children and adults to include lactating and pregnant women), environmental safety and human health at the intended conditions of use. 

 

The FSS risk management recommendations and safety assessment can be found below:  

 

FSS safety assessment: Assessment of 3-Fucosyllactose (3-FL) as a Novel Food for Use in Food and Food Supplements (RP2106) | Published in FSA Research and Evidence 

 

Annex L:  RP2114 - 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

 

64. Background

An application was received from Chr. Hansen A/S, Denmark for the authorisation of the novel food, 6’-Sialyllactose (6’-SL) sodium salt (produced by a derivative strain of Escherichia coli BL21 (DE3)). 

 

This application seeks approval for use in food supplements and a number of food categories, including infant formula and follow-on formula. The FSS concluded that the novel food is safe under the proposed conditions of use and does not pose a risk to human health, with intake levels not considered nutritionally disadvantageous. 

 

For new novel foods and modifications of use to authorised novel foods to be placed on the market in GB, an application shall be submitted in accordance with assimilated EU Regulation 2015/2283. 

 

65. Trade 

Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs. 

 

66. European Union (EU) 

 

Please see information outlined at the start of this document regarding the proposed SPS Agreement with the EU.  

 

In the EU, 6’-Sialyllactose (6’-SL) sodium salt (produced by a derivative strain of Escherichia coli BL21 (DE3)) is currently not authorised for use in food supplements for infants and young children. It is currently permitted in foods for special medical purposes (FSMP) for infants and young children, with a maximum level of 0.70 g/L (or g/kg) in the final product. 

 

In contrast, the GB application combines FSMP categories into a single entry and allows use based on nutritional requirements, without setting a numerical maximum level. It also in food supplements for infants and young children, which is not permitted in the EU. 

 

If authorised, this would result in divergence between GB and EU conditions of use. 

 

67. Northern Ireland 

 

Under the Windsor Framework, a novel food such as 6’- Sialyllactose (6’-SL) sodium salt (produced by derivative strains of Escherichia coli BL21(DE3)) authorised in Scotland may, in limited circumstances, be placed on the Northern Ireland market as part of a qualifying NI‑only prepacked retail food product moved under the Northern Ireland Retail Movement Scheme.  

 

This novel food is already authorised in Northern Ireland. The FSS recommendation to authorise for use in food supplements for infants and young children will lead to some divergence. If approved in GB, this novel food will be able to be placed on the market in Northern Ireland if eligible for and moved through Northern Ireland Retail Movement Scheme. 

 

GB authorisation alone does not permit the novel food to be placed on the Northern Ireland market as an ingredient or for onward manufacture. 

 

 

68. FSS RM Recommendations 

The FSS risk management recommendation is the novel food, 6'-Sialyllactose (6'-SL) sodium salt (produced by derivative strain of Escherichia coli BL21 (DE3)), as described in this application, is safe and is not liable to have an adverse effect on the target population (infants, young children and adults to include lactating and pregnant women), environmental safety and human health under the intended conditions of use. 

 

The FSS risk management recommendations and safety assessment can be found below:  

 

FSS safety assessment: Assessment of Safety of 6′-Sialyllactose (6’-SL) Sodium Salt Produced by Derivative Strains of Escherichia Coli BL21 (DE3) for a New Authorisation (RP2114) | Published in FSA Research and Evidence 

 

Annex M: RP1754 - 6′-Sialyllactose (6′-SL) sodium salt  (produced by a derivative strain of Escherichia coli K-12 (DH1)) (modification of use of authorised novel food

 

69. Background 

 

An application was received by from Glycom A/S, Belgium for the proposed modification of the conditions of use of 6’-Sialyllactose (6’-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)), to permit its use in the additional food categories of food supplements for infants and young children at the following maximum levels: 

 

• Food supplements for infants (persons under the age of 1 year (12 months) at a maximum level of 0.4g/day 
• Food supplements for young children (persons aged between 1 year (12 months) to the age of 3 years (36 months) at a maximum level of 0.3g/day. 

 

Although the application was framed as a modification of the conditions of use of 6’-Sialyllactose (6’-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)), the production-strain-specific specification referred to in the application forms part of the existing authorisation for 6’-Sialyllactose (6’-SL) sodium salt (microbial source) and is not currently authorised as a separate novel food in its own right.

 

To give effect to the application, the proposed authorisation would modify the existing authorisation for 6’-Sialyllactose (6’-SL) sodium salt (microbial source) in relation to the specification produced by a derivative strain of Escherichia coli K-12)) and authorise a new novel food, 6’-Sialyllactose (6’-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)), with a separate specification corresponding to that production strain.

 

No substantive changes are proposed to the specification itself.  

 

The proposed new authorisation would permit use of that novel food in additional food categories as sought in the application. 

 

For new novel foods and modifications of use to authorised novel foods to be placed on the market in GB, an application shall be submitted in accordance with assimilated EU Regulation 2015/2283. 

 

70. Trade 

 

Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs. 

 

71. European Union (EU) 

 

Please see information outlined at the start of this document regarding the proposed SPS Agreement with the EU. 

 

6’-Sialyllactose (6’-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)) is already approved for use in the EU. The EU has not authorised the novel food for use in food supplements for infants and young children. If authorised, this will mean there is divergence between GB and the EU in the uses authorised for this novel food. Apart from use in food supplements for infants and young children, the food categories and intended use levels within this application align with those listed in the EU List of Novel Foods under Commission Implementing regulation - 2017/2470 - EN - EUR-Lex. 

 

72. Northern Ireland 

 

This novel food is already authorised in Northern Ireland. The FSS recommendation to authorise for use in food supplements for infants and young children will lead to some divergence. If approved in Scotland, this novel food will be able to be placed on the market in Northern Ireland if eligible for and moved through Northern Ireland Retail Movement Scheme.   

GB authorisation alone does not permit the novel food to be placed on the Northern Ireland market as an ingredient or for onward manufacture   

 

73. FSS RM Recommendations 

 

The FSS risk management recommendation is the modification of conditions of use of 6′-Sialyllactose (6′-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)) an approved novel food, as described in this application, are safe and are not liable to have an adverse effect on the target population (infants and young children), environmental safety and human health.

 

The FSS risk management recommendations and safety assessment can be found below: 

 

FSS safety assessment:  

 

EFSA’s 2020 assessment (Safety of 6′‐Sialyllactose (6′‐SL) sodium salt as a novel food pursuant to Regulation (EU) 2015/2283 - - 2020 - EFSA Journal - Wiley Online Library) found 6’-SL to be safe at proposed use levels, including in infant formula, foods and supplements, with no identified safety concerns. 

 

Under Regulation (EU) 2015/2283 (Regulation (EU) 2015/2283),  FSS risk assessors reviewed the available evidence to determine whether further evaluation was needed. The additional uses requested are covered by the original safety assessment and do not require further assessment  The use in infant formula and follow on formula as prescribed would mimic this exposure level and mode of consumption, therefore no new risk was presented and therefore no further assessment is required.

 

No adverse effects have been identified; based on the evidence in the original assessment, the additional uses are not expected to pose a risk to human health. 

 

Annex N:  RP1750- Lacto-N-tetraose (LNT) (produced by a derivative strain of Escherichia coli K-12 (DH1)) (modification of use of authorised novel food

 

74. Background

 

An application was received from Glycom A/S, Belgium for the proposed modification of the conditions of use of Lacto‑N‑tetraose (LNT) (produced by a derivative strain of Escherichia coli K‑12 (DH1)), to permit its use in the additional food category of food supplements for infants. 

 

Although the application was framed as a modification of the conditions of use of Lacto‑N‑tetraose (LNT) (produced by a derivative strain of Escherichia coli K‑12 (DH1)), the production-strain-specific specification referred to in the application forms part of the existing authorisation for Lacto-N-tetraose (‘LNT’) (microbial source) and is not currently authorised as a separate novel food in its own right.

 

To give effect to the application, the proposed authorisation would modify the existing authorisation for Lacto- N -tetraose (‘LNT’) (microbial source) in relation to the specification produced by by a derivative strain of Escherichia coli K‑12 (DH1) and authorise a new novel food, Lacto‑N‑tetraose (LNT) (produced by a derivative strain of Escherichia coli K‑12 (DH1)), with a separate specification corresponding to that production strain. No substantive changes are proposed to the specification itself.  

 

The proposed new authorisation would permit use of that novel food in the additional food category as sought in the application.  

 

For new novel foods and modifications of use to authorised novel foods to be placed on the market in GB, an application shall be submitted in accordance with assimilated EU Regulation 2015/2283. 

 

75. Trade 

 

Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs. 

 

76. European Union (EU) 

 

Please see information outlined at the start of this document regarding the proposed SPS Agreement with the EU.

 

Lacto‐N‐tetraose (LNT) (produced by a derivative strain of Escherichia coli K-12 (DH1)) is already approved for use in the EU. 

 

Apart from its proposed use in food supplements for infants, the food categories and intended use levels within this application align with those listed in the EU List of Novel Foods under Commission Implementing regulation - 2017/2470 - EN - EUR-Lex .   

 

While the EU has not authorised the novel food for use in food supplements for infants, this decision is not based on safety concerns, as both the EU and UK have assessed the novel food to be safe at the proposed levels for infant use. 

 

If authorised, this will mean there is divergence between GB and the EU in the uses authorised for this novel food. This divergence will also be reflected in the labelling of supplements.  In the EU food supplements for any age must be labelled with a statement that they should not be used if breast milk or other food containing added Lacto‐N‐tetraose (LNT) is consumed the same day. The proposed amendment in Scotland will require all supplements to be labelled with a warning that refers to other foods with added LNT and food supplements intended for infants and young children must bear a similar statement which also refers to breast milk.  

 

 

77. Northern Ireland 

 

This novel food is already authorised in Northern Ireland. The FSS recommendation to authorise for use in food supplements for infants will lead to some divergence in authorised uses and labelling. If approved in Scotland, this novel food will be able to be placed on the market in Northern Ireland if eligible for and moved through Northern Ireland Retail Movement Scheme.   

GB authorisation alone does not permit the novel food to be placed on the Northern Ireland market as an ingredient or for onward manufacture   

 

78. FSS Risk Management Recommendations 

 

The FSS risk management recommendation is the modification of use of Lacto-N-tetraose (LNT) (produced by a derivative strain of Escherichia coli K-12(DH1)), an approved novel food, as described in this application, is safe and is not liable to have an adverse effect on the target population (infants), environmental safety and human health at the intended conditions of use. 

 

Safety Assessment Summary:  

 

EFSA’s 2019 assessment (Safety of lacto‐N‐tetraose (LNT) as a novel food pursuant to Regulation (EU) 2015/2283 - 2019) found Lacto-N-tetraose (LNT) to be safe at proposed use levels, including in infant formula, foods and food supplements, with no identified safety concerns.  Under Regulation (EU) 2015/2283 (Regulation (EU) 2015/2283), FSS risk assessors reviewed the available evidence (consistent with EFSA review (Safety of the extension of use of 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture and lacto‐N‐tetraose (LNT) as novel foods in food supplements for infants pursuant to Regulation (EU) 2015/2283 - - 2022 - EFSA Journal - Wiley Online Library)) to determine whether further evaluation was needed. Although the original EFSA assessment did not specifically assess use in food supplements for infants, FSS risk assessors concluded that its safety findings were applicable to the proposed use because infant exposure from supplements at the proposed levels would be comparable to exposure levels previously assessed and to levels naturally occurring in breast milk. Consequently, no further safety assessment was considered necessary. No adverse effects have been identified; based on the evidence in the original assessment, the additional uses are not expected to pose a risk to human health.

 

Annex O:  RP2101 - 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)

 

79. Background 

 

An application was received from Chr. Hansen A/S, Denmark for the authorisation of the novel food, Lacto‑N‑tetraose (LNT) (produced by derivative strains of Escherichia coli BL21 (DE3)). 

 

This application seeks approval for use in food supplements and five food categories, including infant and follow‑on formula, processed cereal-based foods, baby foods, and foods for special medical purposes. The FSS concluded that the novel food is safe under the proposed conditions of use and does not pose a risk to human health, with intake levels not considered nutritionally disadvantageous. 

 

For new novel foods and modifications of use to authorised novel foods to be placed on the market in GB, an application shall be submitted in accordance with assimilated EU Regulation 2015/2283. 

 

80. Trade 

 

Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs. 

 

81. European Union (EU) 

 

Please see information outlined at the start of this document regarding the proposed SPS Agreement with the EU.

 

In the EU, a similar application to RP2101 was authorised under Commission Implementing Regulation (EU) 2023/7. For foods for special medical purposes (FSMP), the EU currently sets a maximum level of 1.82 g/L (or g/kg) for infants and young children. In contrast, the GB application combines FSMP categories and allows use based on nutritional requirements, without setting a numerical limit. For food supplements, the GB application allows use in infants and young children (up to 1.82 g/day), whereas the EU currently does not permit use in this group. If authorised, this would result in divergence between GB and current EU conditions of use. 

 

82. Northern Ireland 

 

Under the Windsor Framework, a novel food such as “Lacto-N-tetraose (LNT) (produced by derivative strains of Escherichia coli BL21(DE3)) authorised in GB, may, in limited circumstances, be placed on the Northern Ireland market. If approved in Scotland, this novel food will be able to be placed on the market in Northern Ireland if eligible for, and moved through Northern Ireland Retail Movement Scheme.   

GB authorisation alone does not permit the novel food to be placed on the Northern Ireland market as an ingredient or for onward manufacture 

 

83. FSS Risk Management Recommendations 

 

The FSS risk management recommendation is the novel food, Lacto-N-tetraose (LNT) (produced by derivative strains of Escherichia coli BL21 (DE3)) , as described in this application, is safe and is not liable to have an adverse effect on the target population (infants and young children), environmental safety and human health under the intended conditions of use. 

 

The FSS risk management recommendations and safety assessment can be found below:  

 

FSS safety assessment: Assessment of Lacto-N-tetraose (LNT) as a Novel Food for Use in Food and Food Supplements (RP2101) | Published in FSA Research and Evidence 

 

Annex P:  RP1752 - Lacto-N-neotetraose (LNnT) (produced by a derivative strain of Escherichia coli K‑12 (DH1)) (modification of use of authorised novel food

 

84. Background 

 

An application was received from Glycom A/S, Belgium for the proposed modification of the conditions of use of Lacto-N-neotetraose (LNnT) (produced by a derivative strain of Escherichia coli K‑12 (DH1)), to permit its use in the additional food category of food supplements for infants. It also seeks to remove the condition of use referring to the ratio of lacto-N-neotetraose (LNnT) to the human-identical milk oligosaccharide (HiMO) 2'-FL. 

  

Although the application was framed as a modification of the conditions of use of Lacto-N-neotetraose (LNnT) (produced by a derivative strain of Escherichia coli K‑12 (DH1)) , the production-strain-specific specification referred to in the application forms part of the existing authorisation for Lacto - N - neotetraose (LNnT) (microbial source) and is not currently authorised as a separate novel food in its own right.

 

To give effect to the application, the proposed authorisation would modify the existing authorisation for Lacto - N - neotetraose (LNnT) (microbial source) in relation to the specification produced by a derivative strain of Escherichia coli K‑12 (DH1) and authorise a new novel food, Lacto-N-neotetraose (LNnT) (produced by a derivative strain of Escherichia coli K‑12 (DH1)), with a separate specification corresponding to that production strain. No substantive changes are proposed to the specification itself.  

  

The proposed new authorisation would permit use of that novel food in the additional food category as sought in the application.  

 

For new novel foods and modifications of use to authorised novel foods to be placed on the market in GB, an application shall be submitted in accordance with assimilated EU Regulation 2015/2283. 

85. Trade 

 

Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs.

 

86. European Union (EU) 

 

Please see information outlined at the start of this document regarding the proposed SPS Agreement with the EU.  

 

Lacto‐N‐neotetraose (LNnT) (produced by a derivative strain of Escherichia coli K‑12 (DH1)) is already approved for use in the EU. Lacto-N-neotetraose (produced by a derivative strain of Escherichia coli K-12 (DH1)) is already approved for use in the EU. The original authorisation and subsequent modifications of use for this product are currently identical in the EU and GB. 

 

The proposed modification to allow use in infant supplements will diverge from the EU’s authorisation. 

 

87. Northern Ireland 

 

Lacto‐N‐neotetraose LNnT (produced by a derivative strain of Escherichia coli K‑12 (DH1)) is currently authorised for use in the EU and therefore Northern Ireland. An application for a modification of use to include food supplements for infants has been submitted in the EU but has not yet concluded.  

 

Under the Windsor Framework, Lacto‐N‐neotetraose LNnT (produced by a derivative strain of Escherichia coli K‑12 (DH1)) authorised for use in GB under this modification of use may be placed on the market in Northern Ireland via the Northern Ireland Retail Movement Scheme (NIRMS), provided the product is eligible for the scheme and all applicable NIRMS conditions are met.  

 

GB authorisation alone does not permit the novel food to be placed on the Northern Ireland market as an ingredient or for onward manufacture.

 

88. FSS Risk Management Recommendations 

 

The FSS risk management recommendation is the modification of use of Lacto-N-neotetraose (LNnT) , an approved novel food, as described in this application, is safe and is not liable to have an adverse effect on the target population (infants), environmental safety and human health at the intended conditions of use. 

 

The FSS risk management recommendations and safety assessment can be found below:  

 

FSS safety assessment:   

 

EFSA’s 2015 assessment ((Safety of 2′‐O‐fucosyllactose as a novel food ingredient pursuant to Regulation (EC) No 258/97 - - 2015) ) found 2’-FL to be safe at proposed use levels, including in infant formula, foods and supplements, with no identified safety concerns. 

 

Under Commission Implementing Regulation (EU) 2015/2283 (Regulation (EU) 2015/2283), FSS risk assessors reviewed the available evidence (consistent with EFSA review (Safety of the extension of use of 2’‐fucosyllactose (2’‐FL) and lacto‐N‐neotetraose (LNnT) as novel foods in food supplements for infants pursuant to Regulation (EU) 2015/2283 - - 2022) to determine whether further evaluation was needed.

 

The additional uses requested are covered by the original safety assessment and do not require further assessment.

 

No adverse effects have been identified; based on the evidence in the original assessment, the additional uses are not expected to pose a risk to human health. 

 

Annex Q:  RP2213 - Astaxanthin-rich Oleoresin from Haematococcus ⁠pluvialis Algae used as a novel food (modification of specification and conditions of use)

 

89. Background 

 

An application was recieved from AstaReal AB (Sweden) to modify the specifications and conditions of use for the authorised novel Astaxanthin (ATX)-rich oleoresin from Haematococcus pluvialis algae.  

 

The proposed changes relate to revised specification ranges for Astaxanthin monoesters and diesters, astaxanthin 9‑cis stereoisomer, and protein content, alongside updates to conditions of use and labelling to restrict use to individuals aged 14 years and over, in line with current scientific advice.  

 

Following review, FSS concluded that the novel food is safe under the proposed changes and that it is appropriate to amend the specification, conditions of use and labelling accordingly. 

 

For new novel foods and modifications of use to authorised novel foods to be placed on the market in GB, an application shall be submitted in accordance with assimilated EU Regulation 2015/2283. 

 

 

90. Trade 

 

Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs. 

 

 

91. European Union (EU) 

 

Please see information outlined at the start of this document regarding the proposed SPS Agreement with the EU.

 

The EU has updated its authorisation to introduce age-specific conditions of use, revised labelling requirements, and maximum levels expressed for astaxanthin rather than the oleoresin. In GB, the terms of this authorisation remain as they were in the EU pre-EU exit. If authorised, there will be divergence between the EU and GB as EU have authorised for under 14 years (excluding infants and young children). 

 

92. Northern Ireland 

 

Under the Windsor Framework, a novel food such as Aastaxanthin (ATX)-rich oleoresin from Haematococcus pluvialis algae authorised in Scotland may, in limited circumstances, be placed on the Northern Ireland market as part of a qualifying NI‑only prepacked retail food product moved under the Northern Ireland Retail Movement Scheme.

 

GB authorisation alone does not permit the novel food to be placed on the Northern Ireland market as an ingredient or for onward manufacture. 

 

Allowing the use of food supplements for the age group 14 years and over will lead to divergence within Northern Ireland, as the current EU authorisation allows Astaxanthin (ATX)-rich oleoresin from Haematococcus pluvialis algae in products for those over three years old. 

 

93. FSS RM Recommendations 

 

The FSS risk management recommendation is the modification of specification of use of Astaxanthin-rich Oleoresin from Haematococcus ⁠pluvialis Algae, an approved novel food, as described in this application, is safe and is not liable to have an adverse effect on the target population (general population excluding infants, , young children and adolescents under 14 years), environmental safety and human health under the intended conditions of use. 

 

The FSS risk management recommendations and safety assessment can be found below:  

 

FSS safety assessment 

 

In September 2023, EFSA issued a positive opinion Safety of a change in specifications of the novel food oleoresin from Haematococcus pluvialis containing astaxanthin pursuant to Regulation (EU) 2015/2283 - - 2023 - EFSA Journal - Wiley Online Library on the proposed specification changes for astaxanthin-rich oleoresin from Haematococcus pluvialis, which has been reviewed and supported by the FSS/FSA Assessment on Astaxanthin-rich Oleoresin From Haematococcus ⁠pluvialis Algae Used as a Novel Food (RP2213) | Published in FSA Research and Evidence. EFSA’s current assessment reflects updated scientific evidence, including a revised ADI of 0.2 mg/kg bw/day, and identified potential exceedances for individuals under 14, leading to revised conditions of use excluding this group. 

 

FSS agreed that the novel food is sufficiently characterised, with no changes to the production process compositional data, including historical batch data, supports the proposed specification changes, and no toxicological concerns were identified.  

Overall, FSS concluded that the proposed changes to the specification and conditions of use are safe used in line with the proposed conditions of use. 

 

Annex R:  RP2180 - Schizochytrium sp. Oil Rich in DHA and EPA (modification of specification of authorised novel food)

 

94. Background 

 

An application was received from DSM Nutritional Products Ltd. (Switzerland) to modify the specification of the authorised novel food Schizochytrium sp. oil rich in DHA and EPA.  

 

The novel food is currently authorised in GB and the EU for use in a range of foods, including those intended for infants and young children. The requested change seeks to lower the minimum DHA specification from ≥22.5% to ≥15.0%, reflecting manufacturing improvements, with no other amendments proposed. This modification has already been authorised in the EU at the same levels. 

 

FSS consider that the proposed change does not affect the safety of the novel food and therefore recommend amending the specification accordingly. 

 

For new novel foods and modifications to modifications to authorised novel foods to be placed on the market in GB, an application shall be submitted in accordance with assimilated EU Regulation 2015/2283. 

 

95. Trade 

 

Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs. 

 

96. European Union (EU) 

 

Please see information outlined at the start of this document regarding the proposed SPS Agreement with the EU.  

 

The EU has already approved the modification of the specification at the same levels as requested in this application. If authorised this application would align permissions with the current specification in the EU.  

 

97. Northern Ireland 

 

Under the Windsor Framework, if a novel food such as Schizochytrium sp. Oil Rich in DHA and EPA authorised in GB may, in limited circumstances, be placed on the Northern Ireland market product is approved in GB, it can be placed on the market in Northern Ireland. If approved in GB, this novel food will be able to be placed on the market in Northern Ireland if eligible for and moved through Northern Ireland Retail Movement Scheme.   

GB authorisation alone does not permit the novel food to be placed on the Northern Ireland market as an ingredient or for onward manufacture   

 

98. FSS RM Recommendations 

 

The FSS risk management recommendation is the modification of specification of use of Schizochytrium sp. Oil Rich in DHA and EPA, an approved novel food, as described in this application, is safe and is not liable to have an adverse effect on the target population  (infants, young children and adults to include lactating and pregnant women) environmental safety and human health at the intended conditions of use. 

 

The FSS/FSA risk management recommendations and safety assessment can be found below:  

 

FSS safety assessment: Safety Assessment on the Change of Specification of the Novel Food Schizochytrium sp. Oil Rich in DHA and EPA (RP2180) | Published in FSA Research and Evidence 

Why your views matter

Stakeholders are invited to consider the questions posed in relation to any relevant provisions of law and other legitimate factors as detailed above. Stakeholder responses will be considered along with risk assessment and other factors in development of advice provided to Ministers. Unless the views gathered in the consultation provide additional evidence, the FSS will recommend that these regulated products are authorised on the proposed terms.