Open consultation

Consultation on Market Authorisation of 16 Regulated Food Products September 2026

Published 21 September 2026

1. About

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

The United Kingdom (UK) Government is currently negotiating a Sanitary and Phytosanitary (SPS) Agreement with the European Union (EU). Under the proposed Agreement, the UK would align with all EU legislation within the scope of the Agreement, including market authorisations (subject to any exceptions being agreed during the negotiations with the EU). Once the Agreement enters into force, rules applying in the Great Britain (GB) would be updated in line with EU rules as they changed over time. 

Products already authorised by the EU, and the conditions attached to those authorisations, would also apply in GB once the Agreement enters into force. Existing GB authorisations would cease to apply. For further information, see Regulated products application guidance - GOV.UK  

The risk management proposals set out in this consultation take into account the risk assessments relevant to each application. This includes assessments undertaken by the Food Standards Agency (FSA) and Food Standards Scotland (FSS), for certain applications, EFSA assessments completed when the UK participated in the EU novel foods regime, which the FSA considered sufficient such that no further assessment was required. Our risk management proposals, as detailed in the proposed terms of authorisation for each application reflect this, and may differ from those currently authorised in the EU. If there is an agreement to dynamically align with EU authorisations, those ingredients will not be permitted in the food categories that are not included in the EU authorisation. Furthermore, where the authorised food categories are the same in GB and the EU, the EU authorisation conditions—including any maximum use levels and other risk management measures would apply in place of the corresponding GB authorisation conditions. 

1.1 Launch date: 21 September 2026 

1.2 Respond by: 16 November 2026 

1.3 This consultation will be of most interest to: 

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

A parallel consultation [Insert link] is being published by Food Standards Scotland (FSS)  

1.4 Purpose of the consultation 

This consultation seeks stakeholders’ views, comments and feedback in relation to the regulated product applications considered in this document, which have been submitted for: 

• New authorisations for 6 novel foods. 

• Modification of authorisation of 9 novel foods (including 2 applications relating to the same novel food). 

1.5 How to respond 

Responses to this consultation should be submitted via the  online survey (Opens in a new window). If this is not possible, you can email a response to: 

Email: RPconsultations@food.gov.uk 

Full details on how to respond are given below. 

1.6 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

Novel foods are foods that were not used for human consumption to a significant degree within the UK or EU before 15 May 1997 and that fall within at least one of the categories specified in Article 3(2)(a)(i) to (x) of Assimilated Regulation 2015/2283. 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 Assimilated Regulation 2015/2283. Background on 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 on 01 January 2024. References to any legislation with ‘EU’ or ‘EC’ in the title should now be regarded as assimilated law where applicable to GB. Assimilated law is published on legislation gov.uk. References to ‘Retained EU Law’ or ‘REUL’ should now be regarded as references to assimilated law. 

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 four-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 GB 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 NIRMS. 

• Under NIRMS, regulated products which have been authorised in GB, will be able to be placed on the market in Northern Ireland if they meet this criteria. 

• The Food Standards Agency (FSA) remain committed to ensuring that consumers across the UK 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 

The FSA and FSS risk assessors deliver the science behind our advice. They are responsible for identifying and characterising hazards and risks to health and assessing exposure levels. Where undertaken, links to the safety assessment for each application can be found in the relevant corresponding annex below. 

Risk Management

The FSA risk management recommendation document presents the risk factors already 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.

2. Details of consultation 

2.1 Introduction 

This consultation seeks views on 16 regulated products applications for novel foods.  

An overview of the details for each of the applications can be found in the below annexes. For full and further information, please refer to the risk management recommendations document as hyperlinked in the corresponding annex.  

The Food Standards Agency (FSA) is seeking views from stakeholders on the applications for authorisation referenced above, its risk management advice in respect of them, and the terms on which each one is proposed to be authorised. Stakeholders are invited to comment on the proposals, including in relation to labelling requirements or any other legitimate factors (i.e. social, environmental, economic etc) which may be relevant. Stakeholders are invited to use this opportunity to comment on these factors or highlight any additional factors that should be brought to the attention of ministers to inform their decision making.   

Following the consultation, the next step is for the FSA to write to ministers in England and Wales with their recommendations. Food Standards Scotland (FSS) will write to the minister in Scotland with their recommendations. Ministers in Northern Ireland will be kept informed. This is in line with FSA and FSS responsibility to provide advice, information or assistance to ministers in respect of matters connected with food safety or other interests of consumers in relation to food (section 6, Food Standards Act 1999 and section 3, Food (Scotland) Act 2015). Relevant ministers will then make decisions on authorisation, taking into account the safety assessment, any relevant provisions of assimilated law and any other legitimate factors, including those raised during the consultation process.  

With regard to applications whereby the proposed authorisation would modify an existing authorisation as a modification of the conditions of use of the original authorisation, the production-strain-specific specification referred to in the application, forms part of the existing authorisation and is not currently authorised as a separate novel food in its own right. To give effect to those relevant applications, the proposed authorisation would modify the existing authorisation in relation to the specification and authorise a new novel food, with a separate specification corresponding to the specified production strain. No substantive changes are proposed to the specification itself.   

2.2 Other Legitimate Factors 

In developing the risk management recommendations, the FSA 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.  

2.3 Impacts 

As part of the risk analysis and risk management process, the FSA has assessed the potential impacts that would result from the proposals. The impacts considered included those most frequently identified as potential impacts when authorising food and feed products (i.e. environmental, trade, political, environmental, societal, technical feasibility, and consumer interests).  

For the applications in this consultation, no significant impacts have been identified. Individual impacts in respect of Northern Ireland, including trade and, other legitimate factors, for each application are listed in the corresponding risk management document for each application. The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

2.4 Engagement and Consultation Process 

Details of all valid applications for regulated products are published monthly on the Register of Regulated Product Applications - available on the FSA website.  

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

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

2.5 Questions 

Questions asked in this consultation (for all applications): 

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

• 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 FSA and FSS risk management recommendations)? 

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

• 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). 

• 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? 

2.6 Responses 

Responses are required by 23:59 16 November 2026. Please state, in your response, whether you are responding as a private individual or on behalf of an organisation/company (including details of any stakeholders your organisation represents). 

Please respond to the consultation via the online survey (Opens in a new window). If this is not possible, you can email a response to: RPconsultations@food.gov.uk  

Please indicate which application(s)/product(s) you are responding about by using the following subject line for your response: Response to RP1751 RP1753 RP2119 RP2155 RP2257 RP1755 RP2121 RP2001 RP2106 RP2114 RP1754 RP1750 RP2101 RP1752 RP2213 RP2180 (select which is/are appropriate) consultation on novel foods. 

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

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

For information on how the FSA handles your personal data, please refer to the Consultation privacy notice.  

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

2.7 Further information 

If you require a more accessible format of this document, please send details to the named contact for responses to this consultation and your request will be considered. 

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

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

 Regulated Products Service Delivery    

3. Annex A:  RP1751 

3.1 2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Escherichia coli K-12(DH1)) (modification of use of authorised novel food) 

3.2 Background 

An application was received by the FSA 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. 

3.3 Trade 

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

3.4 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.      

3.5 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise for use in food supplements for infants 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. 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise for use in food supplements for infants 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.  

3.6 FSA Risk Management Recommendation 

The FSA risk management recommendation is the conditions 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, are safe and are not liable to have an adverse effect on the target population(infants), environmental safety and human health.  

3.7 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), FSA 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, FSA 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. 

https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.4184https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.4184https://www.legislation.gov.uk/eur/2015/2283/contents 

4. Annex B:  RP1753

4.1 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) 

4.2 Background 

An application was received by the FSA 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. 

4.3 Trade 

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

4.4 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 using 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 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 (2’-FL/DFL) mixture is consumed the same day. The proposed amendment in England and Wales will only require the statement to refer to food supplements intended for infants and young children.  

4.5 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise for use in food supplements for infants 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. 

4.6 FSA Risk Management Recommendation 

The FSA risk management recommendation is 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.   

4.7 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 mix 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), FSA 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 EFSA opinion assessed the proposed uses. FSA 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.  

https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5717 

5. Annex C: RP2119

5.1 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) 

5.2 Background 

An application was received by the FSA 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 new 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. 

5.3 Trade 

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

5.4 European Union (EU) 

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

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. 

5.5 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’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 GB, 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. 

5.6 FSA Risk Management Recommendation 

The FSA risk management recommendation and safety assessment can be found below.  

The FSA 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 and pregnant women) environmental safety and human health at the intended levels of use. 

FSA and 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 

6. Annex D:  RP2155

6.1 2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Escherichia coli BL21 (DE3))(modification of use of authorised novel food)  

6.2 Background 

An application was received by the FSA 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. It also seeks to remove the condition of use referring to the combination of 2’-FL with 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 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(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 E). 

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. 

6.3 Trade 

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

6.4 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’-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 GB authorisations with those updated EU levels. 

6.5 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise 2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Escherichia coli BL21(DE1)) will align with Northern Ireland. If approved in GB, this novel food will be able to be placed on the Northern Ireland market.  

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

6.6 FSA Risk Management Recommendation 

The FSA risk management recommendations and safety assessment can be found below.  

The FSA risk management recommendation is that 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 at the intended conditions of use. 

FSA and 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 

7. Annex E:  RP2257

7.1 2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Escherichia Coli BL21 (DE3)) (modification of specification of authorised novel food)  

7.2 Background 

An application was received by the FSA 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’-Fucosyllactose (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) (DE3), with a separate specification corresponding to that production strain. This has also been explained in connection with RP2155 (see Annex D) 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. 

7.3 Trade 

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

7.4 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 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. 

7.5 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’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 GB, this novel food will be able to be placed on the Northern Ireland market.  

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

7.6 FSA Risk Management Recommendation 

The FSA risk management recommendation and safety assessment can be found below:  

The FSA risk management recommendation is that the modification of the 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 at the intended conditions of use.  

FSA and 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 

8. Annex F:  RP1755

8.1 3′-Sialyllactose (3′-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)) (modification of use of authorised novel food)  

8.2 Background 

An application was received by the FSA 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. 

8.3 Trade 

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

8.4 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 .   

8.5 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise 3′-Sialyllactose (3′-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)) 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, 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. 

8.6 FSA Risk Management Recommendation 

The FSA risk management recommendation and safety assessment summary can be found below.  

The FSA 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, are safe and are not liable to have an adverse effect on the target population (infants and young children), environmental safety and human health. 

8.7 Safety Assessment Summary  

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 

9. Annex G:  RP2121

9.1 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)  

9.2 Background 

An application was received by the FSA from Chr. Hansen A/S (Denmark), 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. 

9.3 Trade 

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

9.4 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’-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. 

9.5 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise 3′-Sialyllactose (3′-SL) sodium salt (produced by a derivative strain of Escherichia coli BL21 (DE3)) for use in food supplements for infants and young children and the absence of fixed limits for foods for special medical purposes 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, the Northern Ireland Retail Movement Scheme.  

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. 

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

9.6 FSA Risk Management Recommendation 

The FSA risk management recommendation and safety assessment cFSA and 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 an be found below.  

The FSA 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 at the intended conditions of use. 

FSA and 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 

10. Annex H: RP2001

10.1 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)  

10.2 Background 

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

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. 

10.3 Trade 

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

10.4 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 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). 

10.5 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise 3 Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 (MG1655)) for use in food supplements for young children and at different maximum use levels uses authorised for this novel food, will lead to some divergence. Further differences have been identified in the conditions of use and product specifications. The proposed GB authorisation includes the food category “Breakfast cereals, ready to eat” and refers to Salmonella spp. being absent in 100 g and Cronobacter sakazakii being absent in 100 g, the EU specification currently refers to Salmonella sp. being absent in 25 g and Cronobacter (Enterobacter) sakazakii being absent in 10 g. 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, 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 

10.6 FSA Risk Management Recommendation 

The FSA risk management recommendation and safety assessment can be found below.  

The FSA 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 (infants, young children and adults to include lactating and pregnant women), environmental safety and human health at the intended levels of use. 

FSA and 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 

11. Annex I:  RP2106

11.1 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)  

11.2 Background 

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

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. 

11.3 Trade 

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

11.4 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) generally 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 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. 

11.5 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise 3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli (BL21 (DE3)) for use in food supplements for infants and young children, lower maximum use levels, and the absence of fixed limits for foods for special medical purposes 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. 

11.6 FSA Risk Management Recommendation 

The FSA risk management recommendation and safety assessment can be found below.  

The FSA 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. 

FSA and 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 

12. Annex J:  RP2114

12.1 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)  

12.2 Background 

An application was received by the FSA 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 FSA 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. 

12.3 Trade 

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

12.4 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 allows use 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. 

12.5 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise 6’-Sialyllactose (6’-SL) sodium salt (produced by derivative strains of Escherichia. coli BL21 (DE3)) for use in food supplements for infants and young children and the absence of fixed limits for foods for special medical purposes 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, 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. 

12.6 FSA Risk Management Recommendation 

The FSA risk management recommendation and safety assessment can be found below.  

The FSA risk management recommendation is that 6’-Sialyllactose (6’-SL) sodium salt (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, young children and adults to include lactating and pregnant women), environmental safety and human health at the intended conditions of use. 

FSA and 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 

13. Annex K:  RP1754

13.1 6′-Sialyllactose (6′-SL) sodium salt  (produced by a derivative strain of Escherichia coli K-12 (DH1)), (modification of use of authorised novel food)  

13.2 Background 

An application was received by the FSA 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. 

13.3 Trade 

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

13.4 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 .   

13.5 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise 6′-Sialyllactose sodium salt (6′-SL) (produced by a derivative strain of Escherichia coli K-12 (DH1)) 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.   

13.6 FSA Risk Management Recommendation 

The FSA risk management recommendation and safety assessment summary can be found below.  

The FSA risk management recommendation is the 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. 

13.7 Safety Assessment Summary   

EFSA’s 2020 assessment (Safety of 6′‐Sialyllactose (6′‐SL) sodium salt as a novel food pursuant to Regulation (EU) 2015/2283 - - 2020 ) found 6’-Sialyllactose 6’-SL 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), 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. 

14. Annex L:  RP1750

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

14.2 Background 

An application was received by the FSA 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 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. 

14.3 Trade 

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

14.4 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 England and Wales 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.  

14.5 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise Lacto-N-tetraose (LNT) (produced by a derivative strain of Escherichia coli K-12(DH1)) for use in food supplements for infants will lead to some divergence in authorised uses and labelling. 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, 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.   

14.6 FSA Risk Management Recommendation 

The FSA risk management recommendation and safety assessment summary can be found below. 

The FSA 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. 

14.7 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), FSA 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, FSA 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.   

15. Annex M:  RP2101

15.1 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)  

15.2 Background 

An application was received by the FSA 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 FSA 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. 

15.3 Trade 

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

15.4 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.https://eur-lex.europa.eu/eli/reg_impl/2023/7/oj/eng. 

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

15.5 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise Lacto-N-tetraose (LNT) (produced by a derivative strain of Escherichia coli BL21 (DE3)) for use in food supplements for infants and young children and the absence of fixed limits for foods for special medical purposes 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, 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. 

15.6 FSA Risk Management Recommendation 

The FSA risk management recommendation and safety assessment can be found below.  

The FSA risk management recommendation is that 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, young children and adults to include lactating and pregnant women), environmental safety and human health at the intended conditions of use. 

FSA and 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 

16. Annex N:  RP1752

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

16.2 Background 

An application was received by the FSA 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. 

16.3 Trade 

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

16.4 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. 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. 

https://eur-lex.europa.eu/eli/reg_impl/2017/2470/oj/eng 

16.5 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise Lacto-N-neotetraose (LNnT) (produced by a derivative strain of Escherichia coli K-12(DH1)) for use in food supplements for infants 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, 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.   

16.6 FSA Risk Management Recommendation 

The FSA risk management recommendation and safety assessment summary can be found below. 

The FSA risk management recommendation is the conditions of use of Lacto-N-neotetraose (LNnT), 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. 

16.7 Safety Assessment Summary  

EFSA’s 2015 assessment (Safety of lacto‐N‐neotetraose as a novel food ingredient pursuant to Regulation (EC) No 258/97 - 2015) found Lacto-N-neotetraose (LNnT) 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), FSA 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. Although the original EFSA assessment did not specifically assess use in food supplements for infants, FSA 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. 

17. Annex O:  RP2213

17.1 Astaxanthin-rich  oleoresin from Haematococcus ⁠pluvialis algae used as a novel food (modification of specification and conditions of use) 

17.2 Background 

An application was received by the FSA 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, the FSA 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 and maximum levels expressed for astaxanthin rather than the oleoresin. 

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. 

17.3 Trade 

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

17.4 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 before the UK left the EU. If authorised, there will be divergence between the EU and GB as EU have authorised for under 14years (excluding infants and young children). 

17.5 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise Astaxanthin (ATX)-rich oleoresin from Haematococcus pluvialis algae for the age group, 14 years and over, 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, 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.   

17.6 FSA Risk Management Recommendation 

The FSA risk management recommendation and safety assessment can be found below.  

The FSA risk management recommendation is the modification of the conditions of use and 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 at the intended conditions of use. 

17.7 FSA and 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 FSA [Assessment on Astaxanthin-rich Oleoresin From Haematococcus ⁠pluvialis Algae Used as a Novel Food (RP2213)

Published in FSA Research and Evidence](https://science.food.gov.uk/article/155718-assessment-on-astaxanthin-rich-oleoresin-from-_haematococcus-pluvialis_-algae-used-as-a-novel-food-rp2213). 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.

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

Overall, the FSA concluded that the proposed changes to the specification and conditions of use are safe under the proposed conditions of use. 

18. Annex P:  RP2180

18.1 Schizochytrium sp. Oil Rich in DHA and EPA (modification of specification of authorised novel food) 

18.2 Background 

An application was received by the FSA 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 in the 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. 

The FSA consider that the proposed change does not affect the safety of the novel food and therefore recommend updating the specification accordingly. 

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. 

18.3 Trade 

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

18.4 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 with the current specification in the EU. 

18.5 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise the change of specification for Schizochytrium sp. Oil Rich in DHA and EPA will align with Northern Ireland. If approved in GB, this novel food will be able to be placed on the Northern Ireland market.  

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

18.6 FSA Risk Management Recommendation 

The FSA risk management recommendation and safety assessment can be found below.  

The FSA risk management recommendation is that 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. 

FSA and 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