Ymgynghoriad agored

Risk Management Recommendations: Authorisation of 16 Regulated Food Products

Cyhoeddwyd 21 Medi 2026

0.1 Risk Management Recommendations:  

0.2 Consultation on Market Authorisation of 16 Regulated Food Products September 2026  

Date of publication: 21 September 2026 

0.3 Document subject and purpose  

In this document we publish the Food Standards Agency (FSA) risk management recommendations on 16 novel food applications. 

Our risk assessors deliver the science behind our advice and, where undertaken, publish their safety assessments, links to which are available within each recommendation annex. Risk assessors are responsible for identifying and characterising hazards and risks to health and assessing levels of exposure. 

The risk management recommendations consider the safety assessments (which, where undertaken, represent the opinion of the FSA for each application) as well as potential  impacts that may result from the authorisation of these applications. They also consider other legitimate factors that ministers may want to consider before making a decision on authorisation of these applications. 

The final FSA recommendations that are made to ministers in England and Wales, will consider stakeholders’ views received from this consultation. 

The UK Government is as at the date of 21 September 2026 negotiating a Sanitary and Phytosanitary (SPS) Agreement with the European Union (EU).  Under the proposed Agreement, the UK would align with all EU legislation within the scope of the Agreement, including market authorisations (subject to any exceptions being agreed during the negotiations with the EU).  Once the Agreement enters into force, rules applying in Great Britain (GB) would be updated in line with EU rules as they changed over time. 

Products already authorised by the EU, and the conditions attached to those authorisations, would also apply in GB once the Agreement enters into force. Existing GB authorisations would cease to apply. For further information 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 FSA and, 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. Annex A: RP 1751

1.1 Risk Management Recommendation 

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

An application for the proposed modification of use in GB of the authorised novel food on the terms below has been submitted. It is for ministers in England and Wales to decide whether to authorise the modification of use of the novel food. 

1.3 Introduction 

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 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 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 market in GB, an application shall be submitted in accordance with assimilated EU Regulation 2015/2283.   

1.4 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. 

EFSA online library 2015 4184 

1.5 Any Relevant Provisions of assimilated law 

• Assimilated Regulation 2017/2469 laying down administrative and scientific requirements for applications: https://www.legislation.gov.uk/eur/2017/2469/contents   

• Assimilated Regulation 2015/2283 on the procedure for authorising the placing on the market of a novel food and updating the list: https://www.legislation.gov.uk/eur/2015/2283/contents    

• Assimilated Regulation 1169/2011 on the provision of food information to consumers: https://www.legislation.gov.uk/eur/2011/1169 

1.6 Terms of Authorisation (ToA)

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 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. The proposed terms of authorisation for that new novel food, including the additional use sought in this application and the removal of the reference to the ratio with LNnT, are set out below:

2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Escherichia coli K-12 (DH1))

Conditions of use

Specified food category	Maximum levels
Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Regulation (EU) 828/2014	60 g/kg
Cereal bars	12.0 g/kg
Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products	9.6 g/l (maximum level refers to products ready to use)
Dairy analogues, including beverage whiteners	1.2 g/l (beverages); 12 g/kg (products other than beverages); 400 g/kg (whitener)
Flavoured drinks	1.2 g/l
Flavoured fermented milk-based products including heat-treated products	1.2 g/l (beverages); 19.2 g/kg (products other than beverages)
Follow-on formula as defined in Regulation (EU) No 609/2013	1.2 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Food supplements as defined in the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003	3.0 g/day for persons other than infants and young children; 1.2 g/day for infants (under 12 months) and young children (12 to 36 months)
Foods for special medical purposes as defined in Regulation (EU) No 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended
Infant formula as defined in Regulation (EU) No 609/2013	1.2 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Milk-based drinks and similar products intended for young children (12 to 36 months)	1.2 g/l for beverages in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013	12.0 g/kg for products other than beverages; 1.2 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer
Table-top sweeteners	200 g/kg
Total diet replacement for weight control as defined in Regulation (EU) No 609/2013	4.8 g/l for beverages; 40 g/kg for bars
Unflavoured fermented milk-based products	1.2 g/l (beverages); 19.2 g/kg (products other than beverages)
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk-based products	1.2 g/l

Additional specific labelling requirements

The designation of the novel food on the labelling of the food containing it is ‘2’-Fucosyllactose’.

The labelling of food supplements containing 2’-Fucosyllactose must bear a statement that the supplements should not be consumed if food with added 2’-Fucosyllactose is consumed on the same day.

The labelling of food supplements containing 2’-Fucosyllactose for infants and young children must bear a statement that the supplements should not be consumed if breast milk or food with added 2’-Fucosyllactose are consumed on the same day.

The food information must be presented in accordance with the provisions of Regulation (EU) No 1169/2011 which apply to mandatory food information.

1.7 Specification 

• No substantive changes to the specification are proposed.  

1.8 Proposed Uses 

The novel food is intended for use in the food categories specified in the Terms of Authorisation (TOA) table above. The application seeks authorisation of 2’-fucosyllactose (2’-FL), (produced using a derivative strain of E. coli K-12 (DH1)), for use in infant supplements in Great Britain. 

The novel food is intended for the general population, including infants and young children, across a wide range of food categories, including dairy products, infant and follow-on formula, baby foods, drinks, foods for special medical purposes and food supplements. The proposed food categories and use levels are aligned with existing GB authorisations for 2’-FL, where the key change being the extension to allow its use in food supplements for infants and remove the condition of use referring to the ratio of 2’-FL to the human-identical milk oligosaccharide (HiMO) lacto-N-neotetraose (LNnT). 

1.9 Supplementary Information  

N/A  

1.10 Labelling 

Article 9(3)(b) of assimilated Regulation (EU) 2015/2283 provides that an authorisation of a novel food should include additional specific labelling requirements. Previous labelling as part of the authorisation remains unchanged, however additional labelling is required. The existing requirement to label food supplements for young children with a statement that they should not be used if breast milk or foods with added 2’-fucosyllactose are consumed on the same day should be extended to apply to the new use in infant supplements. 

It is proposed that the conditions of use for the novel food 2’-fucosyllactose (produced by a derivative strain of Escherichia coli K-12 (DH1)) should be authorised with the same additional specific labelling requirements as the existing authorisations for 2’-fucosyllactose as set out in the register and these are now proposed to be:  

• The designation of the novel food on the labelling of the food containing it must be ‘2′-fucosyllactose. 

• The labelling of food supplements containing 2′-fucosyllactose must bear a statement that the supplements should not be used if other foods with added 2′-fucosyllactose are consumed on the same day. 

• The labelling of food supplements containing 2′-fucosyllactose intended for infants and young children must bear a statement that the supplements should not be used if breast milk or other foods with added 2′-fucosyllactose are consumed on the same day. 

https://www.legislation.gov.uk/eur/2011/1169/contents 

Labels must follow all general food law requirements and supplements must additionally follow the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003 requirements 

1.11 Transitional Requirements / Provisions  

N/A 

1.12 Further Explanation / Rationale 

N/A 

1.13 Post Market Monitoring 

N/A 

1.14 Definitions 

• ‘Infant’ means a child under the age of 12 months, as defined by Article 2(2)(a) of assimilated Regulation (EU) No. 609/2013. 

• ‘Young child’ means   persons aged 1 year (12 months) up to the age of 3 years (36 months), as defined by Article 2(2)(b) of assimilated Regulation (EU) No. 609/2013. 

1.15 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. 

1.16 Impacts  

As part of the risk analysis process, FSA has assessed the potential impacts that would result from the authorisation of this novel food, should ministers decide to authorise. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

1.17 Trade  

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

1.18 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.   

1.19 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. 

1.20 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.

2. Annex B: RP 1753

2.1 Risk Management Recommendation 

2.2 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) 

An application for the modification of use in GB of the authorised novel food on the terms below has been submitted. It is for ministers in England and Wales to decide whether to authorise the modification of use of the novel food. 

2.3 Introduction 

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. 

2.4 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 

2.5 Any Relevant Provisions of assimilated law 

• Assimilated Regulation 2017/2469 laying down administrative and scientific requirements for applications: https://www.legislation.gov.uk/eur/2017/2469/contents   

• Assimilated Regulation 2015/2283 on the procedure for authorising the placing on the market of a novel food and updating the list: https://www.legislation.gov.uk/eur/2015/2283/contents    

• Assimilated Regulation 1169/2011 on the provision of food information to consumers: https://www.legislation.gov.uk/eur/2011/1169

2.6 Terms of Authorisation (ToA)

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. The proposed terms of authorisation for that new novel food, including the additional use sought in this application are set out below:

2’-Fucosyllactose/Difucosyllactose mixture (2’-FL/DFL) (produced by a derivative strain of Escherichia coli K-12 (DH1))

Conditions of use

Specified food category	Maximum levels
Beverages (flavoured drinks)	2.0 g/l
Cereal bars	20 g/kg
Flavoured fermented milk-based products including heat-treated products	2.0 g/l (beverages); 20 g/kg (products other than beverages)
Follow-on formula as defined in Regulation (EU) No 609/2013	1.2 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Food for special medical purposes as defined in Regulation (EU) No 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended
Food supplements as defined in the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003, excluding infants (persons under the age of 1 year (12 months))	4.0 g/day
Food supplements as defined in the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003 for infants (persons under the age of 1 year (12 months))	1.6 g/day for infants up to 6 months of age; 1.2 g/day for infants over 6 months of age
Infant formula as defined in Regulation (EU) No 609/2013	1.6 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013	1.2 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer; 10 g/kg for products other than beverages
Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013	4.0 g/l (beverages); 40 g/kg (products other than beverages)
Unflavoured fermented milk-based products	2.0 g/l (beverages); 20 g/kg (products other than beverages)
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products	2.0 g/l
Milk-based drinks and similar products intended for young children (persons aged 1 year (12 months) up to the age of 3 years (36 months))	1.2 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

Additional specific labelling requirements

The designation of the novel food on the labelling of the food containing it is ‘2’-Fucosyllactose/Difucosyllactose mixture’.

The labelling of food supplements containing 2’-Fucosyllactose/Difucosyllactose mixture must bear a statement that the supplements should not be consumed if food with added 2’-Fucosyllactose and/or Difucosyllactose is consumed on the same day.

The labelling of food supplements containing 2’-Fucosyllactose/Difucosyllactose mixture for infants and young children must bear a statement that the supplements should not be consumed if breast milk or food with added 2’-Fucosyllactose and/or Difucosyllactose are consumed on the same day.

The food information must be presented in accordance with the provisions of Regulation (EU) No 1169/2011 which apply to mandatory food information.

2.7 Specification 

No substantive changes to the specification are proposed.  

2.8 Proposed Uses 

The novel food is intended for use in the food categories specified in the Terms of Authorisation (TOA) table above. The application seeks authorisation of 2′-Fucosyllactose/Difucosyllactose mixture (2’-FL/DFL), produced by a derivative strain of E. coli K-12 (DH1), for use in infant supplements in Great Britain. The novel food is intended for the general population, including infants and young children, across a wide range of food categories, including dairy products, infant and follow-on formula, baby foods, drinks, foods for special medical purposes and food supplements.  The proposed food categories and use levels are aligned with existing GB authorisations for (2’-FL/DFL), where the key change being the extension to allow its use in food supplements for infants (persons under the ages of 1 year (12 months)).  

2.9 Supplementary Information  

N/A 

2.10 Labelling 

Article 9(3)(b) of assimilated Regulation (EU) 2015/2283 provides that an authorisation of a novel food should include additional specific labelling requirements. Previous labelling as part of the authorisation remains unchanged, however, additional labelling is required. 

It is proposed that 2’-fucosyllactose/difucosyllactose mix (produced by a derivative strain of Escherichia coli K-12 (DH1)) should be authorised with the same additional specific labelling requirements as other existing authorisations for human-identical milk oligosaccharide products as set out in the register and these are: 

• The designation of the novel food on the labelling of the food containing it is 2’-Fucosyllactose/Difucosyllactose mixture. 

• The labelling of food supplements containing 2′-Fucosyllactose/Difucosyllactose mixture must bear a statement that the supplements should not be consumed if food with added 2′-Fucosyllactose and/or Difucosyllactose is consumed on the same day. 

• The labelling of food supplements containing 2′-Fucosyllactose/Difucosyllactose mixture for infants, and young children must bear a statement that they should not be consumed if breast milk or food with added 2′-Fucosyllactose and/or Difucosyllactose are consumed on the same day. 

https://www.legislation.gov.uk/eur/2011/1169/contents 

Labels must follow all general food law requirements and supplements must additionally follow the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003 requirements. 

2.11 Transitional Requirements / Provisions  

N/A  

2.12 Further Explanation / Rationale 

N/A 

2.13 Post Market Monitoring 

N/A 

2.14 Definitions 

• Food supplements – as defined in the Food Supplements (England) Regulations 2003 and The Food Supplements (Wales) Regulations 2003.    

• ‘Infant’ means a child under the age of 12 months, as defined by Article 2.2(a) of assimilated Regulation (EU) No 609/2013. 

‘Young child’ means persons aged 1 year (12 months) up to the age of 3 years (36 months) as defined by Article 2.2(b) of assimilated Regulation (EU) No 609/2013. 

2.15 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. 

2.16 Impacts  

As part of the risk analysis process, FSA has assessed the potential impacts that would result from the authorisation of this novel food, should ministers decide to authorise. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

2.17 Trade  

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

2.18 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 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 infants, and young children. 

2.19 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. 

2.20 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.

3. Annex C: RP 2119

3.1 Risk Management Recommendation 

3.2 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) 

An application for the new authorisation of the novel food in Great Britain on the terms below has been submitted. It is for ministers in England and Wales to decide whether to authorise the novel food. 

3.3 Introduction 

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 food 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. 

3.4 Safety Assessment Summary 

The FSA has reviewed the information available, including the EFSA opinion, and confirmed that 2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Corynebacterium glutamicum (ATCC 13032)) was safe under the proposed conditions of use. The anticipated intake levels and proposed use in food and food supplements was not considered to be nutritionally disadvantageous. 

FSA and FSS Safety Assessment: Assessment on 2’-Fucosyllactose (2’-FL) Derived From Genetically Modified Corynebacterium Glutamicum APC199 

3.5 Any Relevant Provisions of assimilated law 

• Assimilated Regulation 2017/2469 laying down administrative and scientific requirements for applications: https://www.legislation.gov.uk/eur/2017/2469/contents   

• Assimilated Regulation 2015/2283 on the procedure for authorising the placing on the market of a novel food and updating the list: https://www.legislation.gov.uk/eur/2015/2283/contents    

• Assimilated Regulation 1169/2011 on the provision of food information to consumers: https://www.legislation.gov.uk/eur/2011/1169

3.6 Terms of Authorisation (ToA)

The proposed terms of authorisation (TOA) are as below:

2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Corynebacterium glutamicum (ATCC 13032))

Conditions under which the novel food may be used

Specified food category	Maximum levels
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk-based products	1.2 g/l
Unflavoured fermented milk-based products	1.2 g/l (beverages); 19.2 g/kg (products other than beverages)
Flavoured fermented milk-based products including heat-treated products	1.2 g/l (beverages); 19.2 g/kg (products other than beverages)
Dairy analogues, including beverage whiteners	1.2 g/l (beverages); 12 g/kg (products other than beverages); 400 g/kg (whitener)
Cereal bars	12.0 g/kg
Table-top sweeteners	200 g/kg
Infant formula as defined in Regulation 609/2013	1.2 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Follow-on formula as defined in Regulation 609/2013	1.2 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based foods and baby foods for infants and young children as defined in Regulation 609/2013	12.0 g/kg (for products other than beverages); 1.2 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer
Milk based drinks and similar products intended for young children (persons aged 1 year (12 months) up to the age of 3 years (36 months))	1.2 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Foods for special medical purposes as defined in Regulation 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended
Total diet replacement for weight control as defined in Regulation 609/2013	4.8 g/l for (beverages); 40 g/kg (products other than beverages)
Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Regulation 828/2014	60 g/kg
Flavoured drinks	1.2 g/l
Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products	9.6 g/l – the maximum level refers to the products ready to use
Food supplements as defined in the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003, excluding food supplements for infants (persons under the age of 12 months)	3.0 g/day for general population; 1.2 g/day for young children (persons aged 1 year (12 months) up to the age of 3 years (36 months))

Additional specific labelling requirements

1. The designation of the novel food on the labelling of food containing it is “2′-Fucosyllactose”.
2. The labelling of food supplements containing 2′-Fucosyllactose must bear a statement that the supplements should not be consumed if other foods with added 2′-Fucosyllactose is consumed on the same day.
3. The labelling of food supplements containing 2′-Fucosyllactose intended for young children must bear a statement that the supplements should not be consumed if breast milk or other food with added 2′-Fucosyllactose is consumed on the same day.

The food information must be presented in accordance with the provisions of Regulation 1169/2011 which apply to mandatory food information.

Data protection

This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation 2015/2283.

Applicant:

Advanced Protein Technologies, Corp. Room 515, Gyeonggi-R&DB Center, 105, Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16229, Republic of Korea, Gwanggyo-ro, southkorea, 16229

During the period of data protection 2’-Fucosyllactose (produced by a derivative strain of Corynebacterium glutamicum (ATCC 13032)) is authorised for placing on the market within Great Britain only by Advanced Protein Technologies Corp. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation 2015/2283 or with the agreement of Advanced Protein Technologies Corp.

The data protection will expire at the end of [Date 5 years from Authorisation]

3.7 Specification

Description

2’-Fucosyllactose (2’-FL) is a white to off-white/ivory powder produced by microbial fermentation using a derivative strain of Corynebacterium glutamicum (ATCC 13032).

Source

Derivative strain of Corynebacterium glutamicum (ATCC 13032.

Definition

Chemical name:(2S,3S,4R,5S,6S)-2-[(2S,3R,4S,5R,6R)-4,5-dihydroxy-6-(hydroxymethyl)-2-[(2R,3S,4R,5R)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-methyloxane-3,4,5-triol

CAS No: 41263-94-9

Molecular weight: 488.44 g/mol

Chemical formula: C18H32O15

Characteristics / Composition

Parameter	Specification
Appearance	powder
Colour	white to off-white
2’-FL	≥ 94.0% w/w dry matter
D-lactose	≤ 3.0% w/w dry matter
L-fucose	≤ 3.0% w/w dry matter
D-glucose	≤ 3.0% w/w dry matter
D-galactose	≤ 3.0% w/w dry matter
3-FL	≤ 3% w/w dry matter
Difucosyllactose	≤ 2% w/w dry matter
Water	≤ 9.0 %
Residual protein	≤ 0.005 %
Ash	≤ 0.5 %

Heavy metals and contaminants

Parameter	Specification
Arsenic	≤ 0.03 mg/kg
Aflatoxin M1	≤ 0.025 µg/kg
Ethanol	≤ 1000 mg/kg

Microbiological criteria

Parameter	Specification
Total plate count	≤ 500 CFU/g
Yeast and mould	≤ 100 CFU/g
Enterobacteriaceae	Absent in 10 g
Salmonella spp.	Absent in 25 g
Cronobacter spp.	Absent in 10 g
Residual Endotoxins	≤ 100 EU/g

CFU: Colony Forming Units

EU: Endotoxin Units

3.8 Proposed Uses 

The novel food is intended for use in the food categories specified in the TOA table above.  

3.9 Supplementary Information  

N/A  

3.10 Labelling 

Article 9(3)(b) of assimilated Regulation (EU) 2015/2283 provides that an authorisation of a novel food should include additional specific labelling requirements. 

Our proposed additional specific labelling requirements are as below: 

• The designation of the novel food on the labelling of the food containing it is ‘2’-Fucosyllactose. 

• The labelling of food supplements containing 2′-Fucosyllactose must bear a statement that the food supplements should not be used if other foods with added 2′-Fucosyllactose are consumed the same day. 

• The labelling of food supplements containing 2′-Fucosyllactose intended for young children must bear a statement that the food supplements should not be used if breast milk or other foods with added 2′-Fucosyllactose are consumed the same day. 

Labels must follow all general food law requirements and supplements must additionally follow the Food Supplements (England) Regulations 2003 and  the Food Supplements (Wales) Regulations 2003 requirements. 

3.11 Transitional Requirements / Provisions  

N/A 

3.12 Further Explanation / Rationale 

N/A 

3.13 Post Market Monitoring 

N/A 

3.14 Definitions 

• ‘Infant’ means a child under the age of 12 months, as defined by Article 2(2)(a) of assimilated Regulation 609/2013. 

• ‘Young child’ means persons aged 1 year (12 months) up to the age of 3 years (36 months), as defined by Article 2(2)(b) of assimilated Regulation 609/2013. 

• “Food supplements” are defined in the  Food Supplements (England) Regulations 2003; Food Supplements (Wales) Regulations 2003 and Food Supplements (Scotland) Regulations 

3.15 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. 

3.16 Impacts  

As part of the risk analysis process, the FSA has assessed the potential impacts that would result from the authorisation of this novel food, should ministers decide to authorise. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

3.17 Trade  

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

3.18 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.  

3.19 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. 

3.20 Risk Management Recommendation 

The FSA risk management recommendation is that 2’-Fucosyllactose (produced by 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.

4. Annex D: RP 2155

4.1 Risk Management Recommendation 

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

An application for the modification of use in GB of the authorised novel food on the terms below has been submitted. It is for ministers in England and Wales to decide whether to authorise the modification of use of the novel food. 

4.3 Introduction 

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

4.4 Safety Assessment Summary 

Under the original authorisation, 2’-Fucosyllactose (2’-FL) was permitted for use in infant formula, follow-on formula and products for young children, initially in combination with Lacto-N-neotetraose (LNnT), and later as a single ingredient at defined levels. Estimated intakes at the proposed higher levels are comparable to, or only slightly above, those from breast milk and current authorised uses.  

EFSA concluded that these increased levels do not raise safety or nutritional concerns, and the FSA agree, noting that the existing EFSA assessment is sufficient for GB risk analysis and no further assessment is required at this time. 

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 

EFSA 2023 Safety Assessment:  [Safety of the extension of use of 2′‐fucosyllactose (2′‐FL) as a novel food pursuant to Regulation (EU) 2015/2283 - - 2023 - EFSA Journal - Wiley Online Library (https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2023.8334) 

4.5 Any Relevant Provisions of assimilated law 

• Assimilated Regulation 2017/2469 laying down administrative and scientific requirements for applications: https://www.legislation.gov.uk/eur/2017/2469/contents   

• Assimilated Regulation 2015/2283 on the procedure for authorising the placing on the market of a novel food and updating the list: https://www.legislation.gov.uk/eur/2015/2283/contents    

• Assimilated Regulation 1169/2011 on the provision of food information to consumers: https://www.legislation.gov.uk/eur/2011/1169

4.6 Terms of Authorisation (ToA)

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. The proposed terms of authorisation for that new novel food, including the increased use levels sought in this application and the removal of the reference to the ratio with LNnT, are set out below:

2′-Fucosyllactose (2’-FL) (produced by a derivative strain of Escherichia coli BL21(DE3))

Conditions of use

Specified food category	Maximum levels
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk-based products	1.2 g/l
Unflavoured fermented milk-based products	1.2 g/l (beverages); 19.2 g/kg (products other than beverages)
Flavoured fermented milk-based products including heat-treated products	1.2 g/l (beverages); 19.2 g/kg (products other than beverages)
Dairy analogues, including beverage whiteners	1.2 g/l (beverages); 12.0 g/kg (products other than beverages); 400 g/kg (whitener)
Cereal bars	12.0 g/kg
Table-top sweeteners	200 g/kg
Infant formula as defined in Regulation 609/2013	3.0 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Follow-on formula as defined in Regulation 609/2013	3.64 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based food and baby food for infants and young children as defined in Regulation 609/2013	12.0 g/kg (for products other than beverages); 1.2 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer
Milk-based drinks and similar products intended for young children (persons aged 1 year (12 months) up to the age of 3 years (36 months))	1.2 g/l for (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Foods for special medical purposes as defined in Regulation 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended
Total diet replacement for weight control as defined in Regulation 609/2013	4.8 g/l (beverages); 40 g/kg (products other than beverages)
Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Regulation 828/2014	60 g/kg
Flavoured drinks	1.2 g/l
Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products	9.6 g/l — the maximum level refers to the products ready to use
Food supplements as defined in as defined in the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003 excluding food supplements for infants (persons under the age of 1 year (12 months))	3.0 g/day for general population; 1.2 g/day for young children (persons aged 1 year (12 months) and up to the age of 3 years (36 months))

Additional Labelling Requirements

1. The designation of the novel food on the labelling of the food containing it is ‘2′-Fucosyllactose’.
2. The labelling of food supplements containing 2′-Fucosyllactose must bear a statement that the supplements should not be consumed if other foods with added 2′-Fucosyllactose is consumed on the same day.
3. The labelling of food supplements containing 2′-Fucosyllactose intended for young children must bear a statement that the supplements should not be used if breast milk or other food with added 2′-Fucosyllactose is consumed on the same day.

The food information must be presented in accordance with the provisions of Regulation 1169/2011 which apply to mandatory food information.

4.7 Specification 

 No substantive changes to the specification are proposed.  

Application RP2257, a separate application (see Annex E below), seeks to update the specifications 2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Escherichia coli BL21 (DE3)) to align with other 2’-Fucosyllactose (2’-FL) authorisations, including increasing the permitted endotoxin limits from ≤0.1 EU/mg to ≤10 EU/mg (powder) and from ≤0.1 EU/µL to ≤10 EU/µL (liquid). 

4.8 Proposed Uses 

The novel food is intended for use in the food categories specified in the Terms of Authorisation (TOA) table above. 

4.9 Supplementary Information  

N/A  

4.10 Labelling 

Existing labelling is suitably protective and does not need amending based on this modification. 

4.11 Transitional Requirements / Provisions  

N/A  

4.12 Further Explanation / Rationale 

N/A 

4.13 Post Market Monitoring 

N/A 

4.14 Definitions 

• ‘Infant’ means a child under the age of 12 months, as defined by Article 2(2)(a) of assimilated Regulation 609/2013. 

• ‘Young child’ means persons aged 1 year (12 months) up to the age of 3 years (36 months), as defined by Article 2(2)(b) of assimilated Regulation 609/2013. 

• “Food supplements” are defined in the  Food Supplements (England) Regulations 2003; and the Food Supplements (Wales) Regulations 2003https://www.legislation.gov.uk/ssi/2003/278/contents. 

4.15 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 will consider as part of their decision on authorisation. The FSA has not identified any applicable other legitimate factors to date that would prevent authorisation or affect the conditions of authorisation of this novel food. As noted above, 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.

The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector.

4.16 Impacts  

As part of the risk analysis process, the FSA has assessed the potential impacts that would result from the authorisation of this novel food, should ministers decide to authorise. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

4.17 Trade  

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

4.18 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. 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. 

4.19 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. 

4.20 Risk Management Recommendation 

The FSA risk management recommendation is that the modification of use of 2’-Fucosyllactose (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.

5. Annex E: RP 2257

5.1 Risk Management Recommendation 

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

An application for the modification of specification in GB of the authorised novel food on the terms below has been submitted. It is for ministers in England and Wales to decide whether to authorise the modification of specification of the novel food. 

5.3 Introduction 

An application was received by the FSA from Chr. Hansen A/S, (Denmark) for the proposed modification of the specification of 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. 

5.4 Safety Assessment Summary 

To support the FSA in their evaluation of the application, the Advisory Committee on Novel Foods and Processes (ACNFP) were asked to review the safety dossier and supplementary information provided by the applicant. The Committee did not consider any potential health benefits or claims arising from consuming the food, as the focus of the novel food assessment is to ensure the modification of the specification is safe, and not putting consumers at a nutritional disadvantage.   

The FSA concluded that the applicant had provided sufficient information to assure that the modification of the specification of 2’-Fucosyllactose (2’-FL), (produced by a derivative strain of Escherichia coli BL21(DE3)), is safe under 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  

5.5 Any Relevant Provisions of assimilated law 

• Assimilated Regulation 2017/2469 laying down administrative and scientific requirements for applications: https://www.legislation.gov.uk/eur/2017/2469/contents   

• Assimilated Regulation 2015/2283 on the procedure for authorising the placing on the market of a novel food and updating the list: https://www.legislation.gov.uk/eur/2015/2283/contents    

• Assimilated Regulation 1169/2011 on the provision of food information to consumers: https://www.legislation.gov.uk/eur/2011/1169

5.6 Terms of Authorisation (ToA)

This application does not propose any changes to the conditions of use to the authorisation for 2’-Fucosyllactose. For reference (2’-Fucosyllactose (2’-FL) (produced by a derivative strain of Escherichia Coli BL21)). 

A separate application (RP2155) seeks to increase the maximum levels for infant formula and follow-on formula for the same product (see Annex D). The terms of authorisation to which this specification relates are produced above in Annex D. As explained in Annex D, 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.  

5.7 Specification 

Changes to the maximum endotoxin levels are proposed as requested in the application; the proposed changes to the specification are highlighted below:

Description

The novel food is a white to off white powder and the liquid concentrate (45 % ± 5 % w/v) aqueous solution is a colourless to slight yellow clear aqueous solution. 2’-Fucosyllactose is manufactured by microbial fermentation using a derivative strain of Escherichia coli BL21 (DE3).

Source

Derivative strain of Escherichia coli BL21 (DE3).

Definition

Chemical name: α-L-Fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose

Chemical formula: C18H32O15

CAS No: 41263-94-9

Molecular weight: 488.44 g/mol

Characteristics/Composition

Parameter	Specification
2’-Fucosyllactose	≥ 90 %
Lactose	≤ 5,.0 %
Fucose	≤ 3,.0 %
3-Fucosyllactose	≤ 5.,0 %
Fucosylgalactose	≤ 3.,0 %
Difucosyllactose	≤ 5.,0 %
Glucose	≤ 3.,0 %
Galactose	≤ 3,.0 %
Water	≤ 9,.0 % (powder)
Ash, sulphated	≤ 0.,5 % (powder and liquid)
Residual proteins	≤ 0.,01 % (powder and liquid)

Heavy metals and contaminants

Parameter	Specification
Lead	≤ 0.,02 mg/kg (powder and liquid)
Arsenic	≤ 0,.2 mg/kg (powder and liquid)
Cadmium	≤ 0.,1 mg/kg (powder and liquid)
Mercury	≤ 0.,5 mg/kg (powder and liquid)

Microbiological criteria

Parameter	Specification
Total plate count	≤ 10⁴ CFU/g (powder), ≤ 5 000 CFU/g (liquid)
Yeasts and Moulds	≤ 100 CFU/g (powder); ≤ 50 CFU/g (liquid)
Enterobacteriaceae/Coliforms	absence in 11g (powder and liquid)
Salmonella spp	negative/100 g (powder), negative/200 ml (liquid)
Cronobacter spp	negative/100 g (powder), negative/200 ml (liquid)
Aflatoxin M1	≤ 0.025 μg/kg (powder and liquid)
Residual Endotoxins	≤ 10 EU/mg (powder), ≤ 10 EU/μl (liquid)

CFU: Colony Forming Units.

EU: Endotoxin Units.

5.8 Proposed Uses 

The novel food is intended for use in the food categories specified in the Terms of Authorisation (TOA) table in Annex D above. No amendments to the use categories are proposed in this application.  

5.9 Supplementary Information  

N/A  

5.10 Labelling 

No amendments or additions to labelling required for the existing authorisation as a result of this modification. 

5.11 Transitional Requirements / Provisions  

N/A  

5.12 Further Explanation / Rationale 

N/A 

5.13 Post Market Monitoring 

N/A 

5.14 Definitions 

N/A 

5.15 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 will consider as part of their decision on authorisation. The FSA has not identified any applicable other legitimate factors to date that would prevent authorisation or affect the conditions of authorisation of this novel food. As noted above, 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.

The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector.

5.16 Impacts  

As part of the risk analysis process, the FSA has assessed the potential impacts that would result from the authorisation of this novel food, should ministers decide to authorise. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

5.17 Trade  

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

5.18 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. If approved, this application would align the GB authorisation with the updated EU specification. 

5.19 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. 

5.20 Risk Management Recommendation 

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.

6. Annex F: RP 1755

6.1 Risk Management Recommendation 

6.2 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) 

An application for the modification of use in GB of the authorised novel food on the terms below has been submitted. It is for ministers in England and Wales to decide whether to authorise the modification of use of the novel food. 

6.3 Introduction 

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. 

6.4 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 

6.5 Any Relevant Provisions of assimilated law 

• Assimilated Regulation 2017/2469 laying down administrative and scientific requirements for applications: https://www.legislation.gov.uk/eur/2017/2469/contents   

• Assimilated Regulation 2015/2283 on the procedure for authorising the placing on the market of a novel food and updating the list: https://www.legislation.gov.uk/eur/2015/2283/contents    

• Assimilated Regulation 1169/2011 on the provision of food information to consumers: https://www.legislation.gov.uk/eur/2011/1169

6.6 Terms of Authorisation (ToA)

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. The proposed terms of authorisation for that new novel food, including the additional uses sought in this application are set out below:

3’-Sialyllactose (3’-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1))

Conditions of use

Specified food category	Maximum levels (expressed as 3’-Sialyllactose)
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products	0.25 g/l
Flavoured fermented milk-based products including heat-treated products	0.25 g/l (beverages); 2.5 g/kg (products other than beverages)
Unflavoured fermented milk-based products	0.25 g/l (beverages); 0.5 g/kg (products other than beverages)
Beverages (flavoured drinks, excluding drinks with a PH less than 5)	0.25 g/l
Cereal bars	2.5 g/kg
Infant formula as defined in Regulation 609/2013	0.2 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Follow-on formula as defined in Regulation 609/2013	0.15 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based food and baby food for infants and young children as defined in Regulation 609/2013	0.15 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer; 1.25 g/kg for products other than beverages
Milk based drinks and similar products intended for young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	0.15 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Total diet replacement foods for weight control as defined in Regulation 609/2013	0.5 g/l (beverages); 5.0 g/kg (products other than beverages)
Food for special medical purposes as defined in Regulation 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended
Food supplements as defined in the Food Supplements (England) Regulations 2003; Food Supplements (Wales) Regulations 2003 excluding food supplements for infants (persons under the age of 1 year (12 months)) and young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	0.5 g/day
Food supplements as defined in the Food Supplements (England) Regulations 2003; Food Supplements (Wales) Regulations 2003 for infants (persons under the age of 1 year (12 months))	0.2 g/day
Food supplements as defined in the Food Supplements (England) Regulations 2003; Food Supplements (Wales) Regulations 2003 for young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	0.15 g/day

Additional specific labelling requirements

• The designation of the novel food on the labelling of the food containing it is ‘3’-Sialyllactose sodium salt’.
• The labelling of food supplements containing 3’-Sialyllactose sodium salt must bear a statement that the supplements should not be consumed if foods containing added 3’-Sialyllactose sodium salt are consumed the same day.
• The labelling of food supplements containing 3’-Sialyllactose sodium salt intended for infants and young children must bear a statement that the supplements should not be consumed if breast milk or food with added 3’-Sialyllactose sodium salt is consumed on the same day.
• The food information must be presented in accordance with the provisions of Regulation 1169/2011 which apply to mandatory food information.

Data protection

This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation 2015/2283.

During the period of data protection, 3’-Sialyllactose (3’-SL) sodium salt (produced using a derivative strain of Escherichia coli K-12 (DH1)) is authorised for placing on the market within Great Britain only by:

Glycom A/S
Kogle Allé 4
2970 Hørsholm
Denmark

unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation 2015/2283 or with the agreement of:

Glycom A/S
Kogle Allé 4
2970 Hørsholm
Denmark.

The data protection will expire at the end of 29th June 2027.

6.7 Specification 

No substantive changes to the specification are proposed 

6.8 Proposed Uses 

The novel food is intended for use in the food categories specified in the Terms of Authorisation (TOA) table above. The application seeks authorisation of 3’-Sialyllactose (3’-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)), for use in infant supplements in Great Britain. 

The novel food is intended for the general population, including infants and young children, across a wide range of food categories, including dairy products, infant and follow-on formula, baby foods, drinks, foods for special medical purposes and food supplements. The proposed food categories and use levels are aligned with existing GB authorisations for 3’-SL, where the key change being the extension to allow its use in food supplements for infants and young children. 

6.9 Supplementary Information 

N/A  

6.10 Labelling 

Article 9(3)(b) of assimilated Regulation (EU) 2015/2283 provides that an authorisation of a novel food should include additional specific labelling requirements. 

Our proposed additional specific labelling requirements are as below: 

• The designation of the novel food on the labelling of the food containing it is ‘3’-Sialyllactose sodium salt’.  

• The labelling of food supplements containing 3’-Sialyllactose sodium salt must bear a statement that they should not be consumed if foods containing added 3’-Sialyllactose sodium salt are consumed the same day. 

• The labelling of food supplements containing 3’-Sialyllactose sodium salt intended for infants and young children must bear a statement that they should not be consumed if breast milk or food with added 3’-Sialyllactose sodium salt is consumed on the same day.  

https://www.legislation.gov.uk/eur/2011/1169/contentsLabels must follow all general food law requirements and supplements must additionally follow the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003 requirements. 

6.11 Transitional Requirements / Provisions  

N/A   

6.12 Further Explanation / Rationale 

N/A   

6.13 Post Market Monitoring 

N/A   

6.14 Definitions 

• ‘Infant’ means a child under the age of 12 months, as defined by Article 2(2)(a) of assimilated Regulation 609/2013. 

• ‘Young child’ means persons aged 1 year (12 months) up to the age of 3 years (36 months) as defined by Article 2(2)(b) of assimilated Regulation 609/2013. 

• “Food supplements” are defined in the  Food Supplements (England) Regulations 2003; and the Food Supplements (Wales) Regulations 2003. 

6.15 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. 

6.16 Impacts  

As part of the risk analysis process, FSA has assessed the potential impacts that would result from the authorisation of this novel food, should ministers decide to authorise. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

6.17 Trade  

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

6.18 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 .   

6.19 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.

6.20 Risk Management Recommendation 

The FSA risk management recommendation is the conditions of use of 3′-Sialyllactose sodium salt (3′-SL) (produced by derivative strains 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.

7. Annex G: RP 2121

7.1 Risk Management Recommendation 

7.2 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 a novel food)  

An application for the authorisation of a novel food for use in GB on the terms below has been submitted. It is for ministers in England and Wales to decide whether to authorise the use of this novel food. 

7.3 Introduction 

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. 

7.4 Safety Assessment Summary 

The FSA carried out a safety assessment of 3’-Sialyllactose (3’-SL) sodium salt (produced by derivative strains of Escherichia Coli BL21 (DE3)). The assessment considered identity, production, composition, intake and toxicological data, and found the product to be comparable to that in human breast milk, with no safety concerns identified under the proposed conditions of use. 

The FSA concluded that the novel food is safe, and the full assessment was published in January 2025. 

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

7.5 Any Relevant Provisions of assimilated law 

• Assimilated Regulation 2017/2469 laying down administrative and scientific requirements for applications: https://www.legislation.gov.uk/eur/2017/2469/contents   

• Assimilated Regulation 2015/2283 on the procedure for authorising the placing on the market of a novel food and updating the list: https://www.legislation.gov.uk/eur/2015/2283/contents    

• Assimilated Regulation 1169/2011 on the provision of food information to consumers: https://www.legislation.gov.uk/eur/2011/1169

7.6 Terms of Authorisation (ToA)

The proposed terms of authorisation (TOA) as below:

3’-Sialyllactose (3’-SL) sodium salt (produced by derivative strains of Escherichia coli BL21 (DE3))

Conditions of use

Specified food category	Maximum Levels
Infant formula as defined in Regulation 609/2013	0.28 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Follow-on formula as defined in Regulation 609/2013	0.28 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based food and baby food for infants and young children as defined in Regulation 609/2013	0.28 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer; 0.28 g/kg for products other than beverages
Milk-based drinks and similar products intended for young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	0.28 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Foods for special medical purposes as defined in Regulation 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended
Food supplements as defined in the Food Supplements (England) Regulations 2003 Food Supplements (Wales) Regulations 2003 for infants(persons under the age of 1 year (12months)) and young children (persons aged between 1 year (12months) up to the age of 3 years (36 months))	0.28 g/day
Food supplements as defined in the Food Supplements (England) Regulations 2003, Food Supplements (Wales) Regulations 2003 excluding food supplements for infants (persons under the age of 1 year (12 months) and young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	0.7 g/day

Additional specific labelling requirements

1. The designation of the novel food on the labelling of the food containing it is ‘3′-Sialyllactose sodium salt’.
2. The labelling of food supplements containing ‘3′-Sialyllactose sodium salt must bear a statement that the supplements should not be consumed if other food with added 3′-Sialyllactose sodium salt is consumed on the same day.
3. The labelling of food supplements for infants and young children must bear a statement that they should not be consumed if breast milk or other food with added 3’-Sialyllactose sodium salt is consumed on the same day.

The food information must be presented in accordance with the provisions of Regulation 1169/2011 which apply to mandatory food information.

Data protection

This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation 2015/2283.

Applicant: Chr. Hansen A/S, Boege Allé 10-12, 2970 Hoersholm, Denmark.

During the period of data protection, 3’-Sialyllactose (3’-SL) sodium salt (produced by derivative strains of Escherichia coli BL21 (DE3)) is authorised for placing on the market, within Great Britain, only by Chr. Hansen A/S unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation 2015/2283 or with the agreement of Chr. Hansen A/S.

The data protection will expire at the end of [5 years after authorisation date] (tbc).

7.7 Specification

Description

3’-Sialyllactose (3’-SL) sodium salt is a white to ivory powder that is produced by a microbiological process using Escherichia coli BL21 (DE3).

Source

Two derivative strains (a production strain and an optional degradation strain) of Escherichia coli BL21(DE3)

Definition

Chemical formula: C₂₃H₃₈NO₁₉Na

Chemical name: N-acetyl-α-D-neuraminyl-(2→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose, sodium salt

Molecular mass: 655.53 Da

CAS No: 128596-80-5

Characteristics/Composition

Parameter	Specification
3’-Sialyllactose	≥ 88.0 % w/w dry matter
3’-Sialyllactulose	≤ 5.0 % w/w dry matter
D-Lactose	≤ 5.0 % w/w dry matter
Sialic acid	≤ 1.5 % w/w dry matter
N-acetyl-D-glucosamine	≤ 1.0 % w/w dry matter
Sum of other carbohydrates	≤ 5.0 % w/w dry matter
Water	≤ 9.0 % w/w
Residual protein	≤ 0.01 % w/w
Ash	≤ 8.5 % w/w
Sodium	≤ 4.2 % w/w

Heavy metals and contaminants

Parameter	Specification
Arsenic	≤ 0.2 mg/kg
Aflatoxin M1	≤ 0.025 µg/kg

Microbiological criteria

Parameter	Specification
Standard plate count	≤ 1,000 CFU/g
Yeast and mould	≤ 100 CFU/g
Enterobacteriaceae	≤ 10 CFU/g
Salmonella spp.	Absent in 25g
Cronobacter spp.	Absent in 10g
Residual Endotoxins	≤ 10 EU/mg

CFU: Colony Forming Units.

EU: Endotoxin Units.

7.8 Proposed Uses 

The novel food is intended for use in the food categories specified in the TOA table above. 

7.9 Supplementary Information  

N/A  

7.10 Labelling 

Article 9(3)(b) of assimilated Regulation (EU) 2015/2283 provides that an authorisation of a novel food should include additional specific labelling requirements. 

Our proposed additional specific labelling requirements are as below: 

• The designation of the novel food on the labelling of food containing it is 3′-Sialyllactose sodium salt’.  

• The labelling of food supplements containing 3′-Sialyllactose sodium salt must bear a statement that the supplements should not be consumed if other food with added 3′-Sialyllactose sodium salt is consumed on the same day. 

• The labelling of food supplements for infants and young children must bear a statement that they should not be consumed if breast milk or other food with added 3’- Sialyllactose sodium salt is consumed on the same day. 

https://www.legislation.gov.uk/eur/2011/1169/contentshttps://www.legislation.gov.uk/eur/2011/1169/contents 

Labels must follow all general food law requirements and supplements must additionally follow The Food Supplements (England) Regulations 2003 and The Food Supplements (Wales) Regulations 2003. 

7.11 Transitional Requirements / Provisions  

N/A 

7.12 Further Explanation / Rationale 

N/A 

7.13 Post Market Monitoring 

N/A 

7.14 Definitions 

• ‘Infant’ means a child under the age of 12 months, as defined by Article 2(2)(a) of assimilated Regulation 609/2013. 

• ‘Young child’ means persons aged 1 year (12 months) up to the age of 3 years (36 months), as defined by Article 2(2)(b) of assimilated Regulation 609/2013. 

• “Food supplements” are defined in the  Food Supplements (England) Regulations 2003; Food Supplements (Wales) Regulations 2003  

7.15 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. 

7.16 Impacts  

As part of the risk analysis process, FSA has assessed the potential impacts that would result from the authorisation of this novel food, should ministers decide to authorise. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

7.17 Trade  

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

7.18 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 currently 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.  

7.19 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 

7.20 Risk Management Recommendation 

The FSA risk management recommendation is that the novel food 3’-Sialyllactose (3’-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.

8. Annex H: RP 2001

8.1 Risk Management Recommendation 

8.2 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).   

An application for the authorisation of a novel food for use in GB on the terms below has been submitted. It is for ministers in England and Wales to decide whether to authorise the use of this novel food. 

8.3 Introduction 

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. 

8.4 Safety Assessment Summary 

The FSA has undertaken the assessment of 3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 (MG1655)) and concluded that the novel food is safe under the new proposed conditions of use and does not pose a safety risk to human health. The anticipated intake level and the proposed use in food and food supplements was not considered to be nutritionally disadvantageous. 

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.   

8.5 Any Relevant Provisions of assimilated law 

• Assimilated Regulation 2017/2469 laying down administrative and scientific requirements for applications: https://www.legislation.gov.uk/eur/2017/2469/contents   

• Assimilated Regulation 2015/2283 on the procedure for authorising the placing on the market of a novel food and updating the list: https://www.legislation.gov.uk/eur/2015/2283/contents    

• Assimilated Regulation 1169/2011 on the provision of food information to consumers: https://www.legislation.gov.uk/eur/2011/1169

8.6 Terms of Authorisation (ToA)

The proposed terms of authorisation (TOA) are set out below:

3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 (MG1655))

Conditions of use

Specified food category	Maximum levels
Infant formula as defined in Regulation 609/2013	1.2 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Follow-on formula as defined in Regulation 609/2013	1.2 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based food and baby food for infants and young children as defined in Regulation 609/2013	0.7 g/l (for liquid food ready for use, marketed as such or reconstituted); 7.0 g/kg (products other than beverages)
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products	1.0 g/l
Dairy analogues	1.0 g/l (beverages); 10.0 g/kg (products other than beverages)
Unflavoured fermented milk-based products	1.0 g/l (beverages); 10.0 g/kg (products other than beverages)
Flavoured fermented milk-based products including heat-treated products	1.0 g/l (beverages); 10.0 g/kg (products other than beverages)
Cereal bars	30.0 g/kg
Breakfast cereals, ready to eat	40.0 g/kg
Milk based drinks and similar products intended for young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	1.2 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Flavoured drinks; Energy and sports drinks	1.0 g/l
Total diet replacement for weight control as defined in Regulation 609/2013	2.0 g/l (beverages); 30.0 g/kg (products other than beverages)
Foods for special medical purposes as defined in Regulation 609/2013	In accordance with nutritional requirements of the persons for whom the products are intended
Food supplements as defined in the Food Supplements (England) Regulations 2003; Food Supplements (Wales) Regulations 2003 and 2003 excluding food supplements for infants (persons under the age of 1 year (12 months)) and young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	5.0 g/day
Food supplements as defined in the Food Supplements (England) Regulations 2003; Food Supplements (Wales) Regulations 2003 for young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	1.2 g/day

Additional specific labelling requirements

• The designation of the novel food on the labelling of food containing it is ‘3-Fucosyllactose’.
• The labelling of food supplements containing 3-Fucosyllactose must bear a statement that the supplements should not be consumed if other food with added 3-Fucosyllactose is consumed on the same day.
• The labelling of food supplements for young children must bear a statement that the supplement should not be consumed if breast milk or other food with added 3-Fucosyllactose is consumed on the same day.
• The food information must be presented in accordance with the provisions of Regulation 1169/2011 which apply to mandatory food information.

Data protection

This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation 2015/2283.

Applicant: Inbiose N.V., Technologiepark Zwijnaarde 82 – bus 41 B-9052 Gent, Belgium

During the period of data protection, 3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 (MG1655)) is authorised for placing on the market within Great Britain only by Inbiose N.V., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation 2015/2283 or with the agreement of by Inbiose N.V.

The data protection will expire at the end of [Date 5 years from Authorisation].

8.7 Specification

Description

The novel food is a water-soluble white to off-white powder composed of ≥ 90.0% w/w dry matter (DM) of 3-Fucosyllactose (3-FL).

Source

Derivative strain of Escherichia coli K-12 (MG1655)

Definition

Chemical formula: C18H32O15

Chemical name: 6-deoxy-alpha-L-galacto-hexopyranosyl-(1→3)-[beta-D-galacto-hexopyranosyl-(1→4)]-D-gluco-hexopyranose

CAS number: 41312-47-4

Molecular weight: 488.48 Da

Characteristics/Composition

Parameter	Specification
3-fucosyllactose	≥ 90.0 % w/w dry matter
D-lactose	≤ 5.0 % w/w dry matter
L-Fucose	≤ 3.0 % w/w dry matter
Sum of Galactose/Glucose	≤ 3.0 % w/w dry matter
Other carbohydrates	≤ 3.0 % w/w dry matter
Residual protein	≤ 0.01 % w/w
Water	≤ 5% w/w
pH (5% solution)	3.0 – 7.5

Heavy metals and contaminants

Parameter	Specification
Total Ash	≤ 0.5%
Arsenic	≤ 0.2 mg/kg
Cadmium	≤ 0.05 mg/kg
Lead	≤ 0.05 mg/kg
Mercury	≤ 0.1 mg/kg
Aflatoxin M1	≤ 0.025 µg/kg
Aflatoxin B1	≤ 0.1 µg/kg

Microbiological Criteria

Parameter	Specification
Standard plate count	≤ 1,000 CFU/g
Yeast	≤ 100 CFU/g
Mould	≤ 100 CFU/g
Residual Endotoxins	≤ 300 EU/1000 mg
Enterobacteriaceae	Absent in 10g
Salmonella spp	Absent in 100g
Cronobacter spp.	Absent in 100g
Listeria Monocytogenes	Absent in 25g
Bacillus cereus	≤ 10 CFU/g

CFU: Colony Forming Units.

EU: Endotoxin Units.

8.8 Proposed Uses 

The novel food is intended for use in the food categories specified in the TOA table above. 

8.9 Supplementary Information  

N/A  

8.10 Labelling 

Article 9(3)(b) of assimilated Regulation (EU) 2015/2283 provides that an authorisation of a novel food should include additional specific labelling requirements. 

Our proposed additional specific labelling requirements are as below: 

• The designation of the novel food on the labelling of the food containing it is ‘3-Fucosyllactose’. 

• Food supplements are not intended to be used if other foods with the added 3-Fucosyllactose or breast milk are consumed on the same day. Therefore, the labelling of the food supplements containing 3-Fucosyllactose must bear a statement that it should not be consumed if other foods containing added 3-Fucosyllactose, including breast milk, are consumed on the same day. Food supplements for young children are not to be consumed if breast milk or other foods with added 3-Fucosyllactose are consumed on the same day. 

https://www.legislation.gov.uk/eur/2011/1169/contentsLabels must follow all general food law requirements and supplements must additionally follow the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003. 

8.11 Transitional Requirements / Provisions  

N/A 

8.12 Further Explanation / Rationale 

N/A 

8.13 Post Market Monitoring 

N/A  

8.14 Definitions 

• ‘Infant’ means a child under the age of 12 months, as defined by Article 2(2)(a) of assimilated Regulation 609/2013. 

• ‘Young child’ means persons aged 1 year (12 months) up to the age of 3 years (36 months), as defined by Article 2(2)(b) of assimilated Regulation 609/2013. 

• “Food supplements” are defined in the  Food Supplements (England) Regulations 2003; and the Food Supplements (Wales) Regulations 2003 

8.15 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. 

8.16 Impacts  

As part of the risk analysis process, FSA has assessed the potential impacts that would result from the authorisation of this novel food, should ministers decide to authorise. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

8.17 Trade  

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

8.18 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 currently are 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 currently “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). 

8.19 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise 3′ Fucosyllactose (3-FL) sodium salt (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. 

8.20 Risk Management Recommendation 

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.

9. Annex I: RP 2106

9.1 Risk Management Recommendation 

9.2 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)  

An application for the authorisation of a novel food for use in GB on the terms below has been submitted. It is for ministers in England and Wales to decide whether to authorise the use of this novel food. 

9.3 Introduction 

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)) was received by the FSA for authorisation 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. 

9.4 Safety Assessment Summary 

The FSA carried out a safety assessment of 3‑Fucosyllactose (3‑FL) (produced by a derivative strain of Escherichia Coli BL21 (DE3)). The assessment considered identity, composition, production, intake and toxicological data, and concluded that the novel food is safe under the proposed conditions of use and does not pose a risk to human health. 

Estimated intakes were not considered nutritionally disadvantageous, and analytical data confirmed the absence of production organisms and compliance with specifications. 

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   

9.5 Any Relevant Provisions of assimilated law 

• Assimilated Regulation 2017/2469 laying down administrative and scientific requirements for applications: https://www.legislation.gov.uk/eur/2017/2469/contents   

• Assimilated Regulation 2015/2283 on the procedure for authorising the placing on the market of a novel food and updating the list: https://www.legislation.gov.uk/eur/2015/2283/contents    

• Assimilated Regulation 1169/2011 on the provision of food information to consumers: https://www.legislation.gov.uk/eur/2011/1169 

• The Food Supplements (Wales) Regulations 2003: The Food Supplements (Wales) Regulations 2003;and the Food Supplements (England) Regulations 2003: Food Supplements (England) Regulations 2003

9.6 Terms of Authorisation (ToA)

The proposed terms of authorisation (TOA) are set out below:

9.7 3’- Fucosyllactose (3’-FL) (Produced by a derivative strain of Escherichia coli BL21 (DE3))

Conditions of use

Specified food category	Maximum Levels
Infant formula as defined in Regulation 609/2013	0.9 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Follow-on formula as defined in Regulation 609/2013	1.2 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based food and baby food for infants and young children as defined in Regulation 609/2013	1.2 g/kg (for products other than beverages); 1.2g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Milk-based drinks and similar products intended for young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	1.2 g/l (beverages)in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Foods for special medical purposes defined in Regulation 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended
Food supplements as defined in the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003 for infants (persons under the age of 1 year (12 months) and young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	1.2 g/day
Food supplements as defined in the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003 excluding food supplements for infants (persons under the age of 1 year (12 months) and young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	3.0 g/day

Additional specific labelling requirements

• The designation of the novel food on the labelling of food containing it is 3′ Fucosyllactose.
• The labelling of food supplements containing 3’- Fucosyllactose must bear a statement that the supplements should not be consumed if other food with added 3’- Fucosyllactose is consumed on the same day.
• The labelling of food supplements for infants and young children must bear a statement that the supplements should not be consumed if breast milk or other food with added 3’- Fucosyllactose is consumed on the same day.
• The food information must be presented in accordance with the provisions of Regulation 1169/2011 which apply to mandatory food information.

Data protection

This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation 2015/2283.

Applicant: Chr. Hansen A/S Boege Allé, 10-12 2970 Hoersholm, Denmark

During the period of data protection, 3’- Fucosyllactose (3’-FL) (produced by a derivative strain of BL21 (DE3)) is authorised for placing on the market within Great Britain, only by Chr. Hansen A/S unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation 2015/2283 or with the agreement of Chr. Hansen A/S.

The data protection will expire at the end of [5 years after authorisation date] (tbc).

9.8 Specification

Description

The novel food is a white to ivory powder composed of ≥ 90% w/w dry matter of 3’-Fucosyllactose (3’-FL).

Source

Derivative strain of Escherichia coli BL21 (DE3)

Definition

Chemical formula: C18H32O15

Chemical name: (2S,3S,4R,5S,6S)-2-[(3R,4R,5R,6R)-2,3-dihydroxy-6-(hydroxymethyl)-5-[(2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxan-4-yl]oxy-6-methyloxane-3,4,5-triol

CAS number: 41312-47-4

Molecular weight: 488.44 Da

Characteristics/Composition

Parameter	Specification
3-fucosyllactose	≥ 90% w/w dry matter
D-lactose	≤ 5% w/w dry matter
L-fucose	≤ 3% w/w dry matter
D-galactose	≤ 3% w/w dry matter
D-glucose	≤ 3% w/w dry matter
*Sum of carbohydrates	≤ 5% w/w dry matter
Water	≤ 9 % w/w
Ash	≤ 1 % w/w
Residual protein	≤ 0.01 % w/w

Heavy metals and contaminants

Parameter	Specification
Arsenic	≤ 0.2 mg/kg
Aflatoxin M1	≤ 0.025 µg/kg

Microbiological criteria

Parameter	Specification
Standard plate count	≤ 1,000 CFU/g
Yeast and mould	≤ 100 CFU/g
Enterobacteriaceae	≤ 10 CFU/g
Salmonella spp	Absent in 25g
Cronobacter spp.	Absent in 10g
Residual Endotoxins (EU/mg)	≤ 10 EU/mg

• Sum of other carbohydrates = 100 (% (w/w) of dry matter) – quantified carbohydrates (% (w/w) of dry matter) – Ash (% (w/w) of dry matter).

CFU: Colony Forming Units.

EU: Endotoxin Units.

9.9 Proposed Uses 

The novel food is intended for use in the food categories specified in the TOA table above.  

9.10 Supplementary Information  

N/A  

9.11 Labelling 

Article 9(3)(b) of assimilated Regulation (EU) 2015/2283 provides that an authorisation of a novel food should include additional specific labelling requirements. 

Our proposed additional specific labelling requirements are as below: 

• The designation of the novel food on the labelling of food containing it is 3’- Fucosyllactose’.  

• The labelling of food supplements containing 3’- Fucosyllactose must bear a statement that the supplements should not be consumed if other food with added 3′- Fucosyllactose is consumed on the same day. 

• The labelling of food supplements for infants and young children must bear a statement that they should not be consumed if breast milk or other food with added 3’- Fucosyllactose is consumed on the same day.  

https://www.legislation.gov.uk/eur/2011/1169/contentsLabels must follow all general food law requirements and supplements must additionally follow The Food Supplements (England) Regulations 2003, and The Food Supplements (Wales) Regulations 2003 requirements. 

9.12 Transitional Requirements / Provisions  

N/A 

9.13 Further Explanation / Rationale 

N/A 

9.14 Post Market Monitoring 

N/A 

9.15 Definitions 

• ‘Infant’ means a child under the age of 12 months, as defined by Article 2(2)(a) of assimilated Regulation 609/2013.  

• ‘Young child’ means (persons aged between 1 year (12 months) up to the age of 3 years (36 months)) as defined by Article 2(2)(b) of assimilated Regulation 609/2013.  

• “Food supplements” are defined in the  Food Supplements (England) Regulations 2003; and the Food Supplements (Wales) Regulations 2003  

9.16 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. 

9.17 Impacts  

As part of the risk analysis process, FSA has assessed the potential impacts that would result from the authorisation of this novel food, should ministers decide to authorise. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

9.18 Trade  

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

9.19 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.  

9.20 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. 

9.21 Risk Management Recommendation 

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.

10. Annex J: RP 2114

10.1 Risk Management Recommendation 

10.2 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)  

An application for the authorisation of a novel food for use in GB on the terms below has been submitted. It is for ministers in England and Wales to decide whether to authorise the use of this novel food. 

10.3 Introduction 

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 derivative strains 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. 

10.4 Safety Assessment Summary 

The FSA carried out a safety assessment of 6′-Sialyllactose (6′-SL) sodium salt, (produced by derivative strains of Escherichia coli BL21 (DE3)). The assessment considered identity, production, composition, intake and toxicological data, and identified no safety concerns under the proposed conditions of use. The FSA concluded that the novel food is safe, and the full assessment was published in March 2025. 

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 

10.5 Any Relevant Provisions of assimilated law 

• Assimilated Regulation 2017/2469 laying down administrative and scientific requirements for applications: https://www.legislation.gov.uk/eur/2017/2469/contents   

• Assimilated Regulation 2015/2283 on the procedure for authorising the placing on the market of a novel food and updating the list: https://www.legislation.gov.uk/eur/2015/2283/contents    

• Assimilated Regulation 1169/2011 on the provision of food information to consumers: https://www.legislation.gov.uk/eur/2011/1169

10.6 Terms of Authorisation (ToA)

The proposed terms of authorisation (TOA) are set out below:

6’-Sialyllactose (6’-SL) sodium salt (produced by derivative strains of Escherichia coli BL21 (DE3))

Conditions of use

Specified food category	Maximum Levels
Infant formula as defined in Regulation 609/2013	0.7 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Follow-on formula as defined in Regulation 609/2013	0.7 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based food and baby food for infants and young children as defined in Regulation 609/2013	0.7 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer; 0.7 g/kg for products other than beverages
Milk-based drinks and similar products intended for young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	0.7 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Foods for special medical purposes as defined in Regulation 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended
Food supplements as defined in the Food Supplements (England) Regulations 2003 and Food Supplements (Wales) Regulations 2003 for infants (persons under the age of 1 year (12 months) and young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	0.7 g/day
Food supplements as defined in the Food Supplements (England) Regulations 2003 and Food Supplements (Wales) Regulations 2003 excluding food supplements for infants (persons under the age of 1 year (12 months)) and young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	1.8 g/day

Additional specific labelling requirements

• The designation of the novel food on the labelling of food containing it is ‘6′-Sialyllactose sodium salt’.
• The labelling of food supplements containing 6′-Sialyllactose sodium salt must bear a statement that the supplements should not be consumed if other food with added 6′-Sialyllactose sodium salt is consumed on the same day.
• The labelling of food supplements for infants and young children must bear a statement that the supplements should not be consumed if breast milk or other food with added 6’-Sialyllactose sodium salt is consumed on the same day.
• The food information must be presented in accordance with the provisions of Regulation 1169/2011 which apply to mandatory food information.

Data protection

This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation 2015/2283.

Applicant: Chr. Hansen A/S Boege Allé, 10-12 2970 Hoersholm, Denmark.

During the period of data protection, 6’-Sialyllactose (6’-SL) sodium salt (produced by derivative strains of Escherichia coli BL21(DE3)) is authorised for placing on the market within Great Britain only by Chr. Hansen A/S, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation 2015/2283 or with the agreement of Chr. Hansen A/S.

The data protection will expire at the end of [5 years after authorisation date] (tbc).

10.7 Specification

Description

6′-Sialyllactose (6′-SL) sodium salt is a white to ivory powder that is produced by a microbiological process using Escherichia coli BL21 (DE3).

Source

Two derivative strains (a production strain and an optional degradation strain) of Escherichia coli BL21(DE3)

Definition

Chemical formula: C₂₃H₃₈NO₁₉Na

Chemical name: N-Acetyl-α-D-neuraminyl-(2→6)-β-D-galactopyranosyl-(1→4)-D-Glucose, sodium salt

Molecular mass: 655.53 Da

CAS No: 157574-76-0

Characteristics/Composition

Parameter	Specification
6’-Sialyllactose sodium salt	≥ 90 % w/w dry matter
6’-Sialyllactulose	≤ 3.0 % w/w dry matter
Sialic acid	≤ 2.0 % w/w dry matter
D-lactose	≤ 5.0 % w/w dry matter
N-Acetylglucosamine	≤ 3.0 % w/w dry matter
Sum of other * carbohydrates	≤ 5.0 % w/w dry matter
Ash	≤ 8.5% w/w
Water	≤ 9.0% w/w
Residual protein	≤ 0.01% (w/w)
Sodium	≤ 4.2 %

Contaminants

Parameter	Specification
Arsenic	< 0.2 (mg/kg)
Aflatoxin M1	≤ 0.025 (µg/kg)

Microbiological criteria

Parameter	Specification
Standard plate count	≤ 1000 CFU/g
Yeast and mould	≤ 100 CFU/g
Residual Endotoxins	≤ 10 EU/mg
Salmonella spp.	Absent in 25 g
Cronobacter spp.	Absent in 10 g
Enterobacteriaceae	≤ 10 CFU/g

• Sum of other carbohydrates = 100 (% (w/w) of dry matter) – 6’-Sialyllactose sodium salt (% (w/w) of dry matter) – quantified carbohydrates (% (w/w) of dry matter) – Ash (% (w/w) of dry matter

CFU: Colony Forming Units.

EU: Endotoxin Units.

10.8 Proposed Uses 

The novel food is intended for use in the food categories specified in the Terms of Authorisation (TOA) table above.  

10.9 Supplementary Information  

N/A  

10.10 Labelling 

Article 9(3)(b) of assimilated Regulation (EU) 2015/2283 provides that an authorisation of a novel food should include additional specific labelling requirements. 

Our proposed additional specific labelling requirements are as below: 

• The designation of the novel food on the labelling of food containing it is 6’-Sialyllactose sodium salt’.   

• The labelling of food supplements containing 6’- Sialyllactose sodium salt must bear a statement that the supplements should not be consumed if other food with added 6’- Sialyllactose sodium salt is consumed on the same day. 

• The labelling of food supplements for infants and young children must bear a statement that they should not be consumed if breast milk or other food with added 6’- Sialyllactose sodium salt is consumed on the same day. 

https://www.legislation.gov.uk/eur/2011/1169/contents 

Labels must follow all general food law requirements and supplements must additionally follow the requirements of  The Food Supplements (England) Regulations 2003 and The Food Supplements (Wales) Regulations 2003 

10.11 Transitional Requirements / Provisions  

N/A 

10.12 Further Explanation / Rationale 

N/A 

10.13 Post Market Monitoring 

N/A 

10.14 Definitions 

• ‘Infant’ means a child under the age of 12 months, as defined by Article 2(2)(a) of assimilated Regulation 609/2013. 

• ‘Young child’ means (persons aged between 1 year (12 months) up to the age of 3 years (36 months)), as defined by Article 2(2)(b) of assimilated Regulation 609/2013. 

• “Food supplements” are defined in the  Food Supplements (England) Regulations 2003; and the Food Supplements (Wales) Regulations 2003 

10.15 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. 

10.16 Impacts  

As part of the risk analysis process, FSA has assessed the potential impacts that would result from the authorisation of this novel food, should ministers decide to authorise. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

10.17 Trade  

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

10.18 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 strains 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. 

10.19 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. 

10.20 Risk Management Recommendation 

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.

11. Annex K: RP 1754

11.1 Risk Management Recommendation 

11.2 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)  

An application for the modification of use in GB of the authorised novel food on the terms below has been submitted. It is for ministers in England and Wales to decide whether to authorise the modification of use of the novel food. 

11.3 Introduction 

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 (DH1) 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. 

11.4 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. 

11.5 Any Relevant Provisions of assimilated law 

• Assimilated Regulation 2017/2469 laying down administrative and scientific requirements for applications: https://www.legislation.gov.uk/eur/2017/2469/contents   

• Assimilated Regulation 2015/2283 on the procedure for authorising the placing on the market of a novel food and updating the list: https://www.legislation.gov.uk/eur/2015/2283/contents    

• Assimilated Regulation 1169/2011 on the provision of food information to consumers: https://www.legislation.gov.uk/eur/2011/1169

11.6 Terms of Authorisation (ToA)

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 (DH1) 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. The proposed terms of authorisation for that new novel food, including the additional uses sought in this application are set out below:

6’-Sialyllactose (6’-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1))

Conditions of use

Food category	Maximum levels (expressed as 6’-Sialyllactose)
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products	0.5 g/l
Unflavoured fermented milk-based products	0.5 g/l (beverages); 2.5 g/kg (products other than beverages)
Flavoured fermented milk-based products including heat-treated products	0.5 g/l (beverages); 5.0 g/kg (products other than beverages)
Beverages (flavoured drinks, excluding drinks with a pH less than 5)	0.5 g/l
Cereal bars	5.0 g/kg
Infant formula as defined in Regulation 609/2013	0.4 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Follow-on formula as defined in Regulation 609/2013	0.3 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based food and baby food for infants and young children as defined in Regulation 609/2013	0.3 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer; 2.5 g/kg for products other than beverages
Milk based drinks and similar products intended for young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	0.3 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Total diet replacement foods for weight control as defined in Regulation 609/2013	1.0 g/l (beverages); 10.0 g/kg (products other than beverages)
Food for special medical purposes as defined in Regulation 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended
Food supplements as defined in the Food Supplements (England) Regulations 2003 and Food Supplements (Wales) Regulations 2003 excluding food supplements for infants (persons under the age of 1 year (12 months) and young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	1.0 g/day
Food supplements as defined in the Food Supplements (England) Regulations 2003 and Food Supplements (Wales) Regulations 2003 for infants (persons under the age of 1 year (12 months))	0.4 g/day
Food supplements as defined in the Food Supplements (England) Regulations 2003 and Food Supplements (Wales) Regulations 2003 for young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	0.3 g/day

Additional specific labelling requirements

• The designation of the novel food on the labelling of the food containing it is ‘6’-Sialyllactose sodium salt’.
• The labelling of food supplements containing 6’-Sialyllactose sodium salt must bear a statement that the supplements should not be consumed if foods containing added 6’-Sialyllactose sodium salt are consumed on the same day.
• The labelling of food supplements containing 6’-Sialyllactose sodium salt intended for infants and young children must bear a statement that the supplements should not be consumed if breast milk or food with added 6’-Sialyllactose sodium salt is consumed on the same day.
• The food information must be presented in accordance with the provisions of Regulation 1169/2011 which apply to mandatory food information.

Data protection

This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation 2015/2283.

During the period of data protection, 6’-Sialyllactose (6’-SL) sodium salt (produced using a derivative strain of Escherichia coli K-12 (DH1)) is authorised for placing on the market within Great Britain only by:

Glycom A/S
Kogle Allé 4
2970 Hørsholm
Denmark

unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation 2015/2283 or with the agreement of:

Glycom A/S
Kogle Allé 4
2970 Hørsholm
Denmark

The data protection will expire at the end of 29th June 2027.

11.7 Specification 

There are no substantive changes to the specification proposed. 

11.8 Proposed Uses 

The novel food is intended for use in the food categories specified in the Terms of Authorisation (TOA) table above. The application seeks authorisation of 6’-Sialyllactose (6’-SL) sodium salt (produced by a derivative strain of Escherichia coli K-12 (DH1)), for use in infant supplements in Great Britain. The novel food is intended for the general population, including infants and young children, across a wide range of food categories, including dairy products, infant and follow-on formula, baby foods, drinks, foods for special medical purposes and food supplements. The proposed food categories and use levels are aligned with existing GB authorisations for 6’-SL, where the key change being the extension to allow its use in food supplements for infants and young children. 

11.9 Supplementary Information 

N/A  

11.10 Labelling 

Article 9(3)(b) of assimilated Regulation (EU) 2015/2283 provides that an authorisation of a novel food should include additional specific labelling requirements. 

Our proposed additional specific labelling requirements are as below: 

• The designation of the novel food on the labelling of the food containing it is ‘6’-Sialyllactose sodium salt’.  

• The labelling of food supplements containing 6’-Sialyllactose sodium salt must bear a statement that they should not be consumed if foods containing added 6’-Sialyllactose sodium salt are consumed on the same day. 

• The labelling of food supplements containing 6’-Sialyllactose sodium salt intended for infants and young children must bear a statement that they should not be consumed if breast milk or food with added 6’-Sialyllactose sodium salt is consumed on the same day.  

https://www.legislation.gov.uk/eur/2011/1169/contentsLabels must follow all general food law requirements and supplements must additionally follow the Food Supplements (England) Regulations 2003 requirements,  the Food Supplements (Wales) Regulations 2003. 

11.11 Transitional Requirements / Provisions 

N/A  

11.12 Further Explanation / Rationale 

N/A 

11.13 Post Market Monitoring 

N/A 

11.14 Definitions 

• ‘Infant’ means a child under the age of 12 months, as defined by Article 2(2)(a) of assimilated Regulation 609/2013. 

• ‘Young child’ means (persons aged between 1 year (12 months) up to the age of 3 years (36 months)), as defined by Article 2(2)(b) of assimilated Regulation 609/2013. 

• “Food supplements” are defined in the  Food Supplements (England) Regulations 2003; and the Food Supplements (Wales) Regulations 2003. 

11.15 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. 

11.16 Impacts  

As part of the risk analysis process, FSA has assessed the potential impacts that would result from the authorisation of this novel food, should ministers decide to authorise. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

11.17 Trade  

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

11.18 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 .   

11.19 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.   

11.20 Risk Management Recommendation 

The FSA risk management recommendation is the conditions of use of 6′-Sialyllactose sodium salt (6′-SL) (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.

12. Annex L: RP 1750

12.1 Risk Management Recommendation 

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

An application for the modification of use in GB of the authorised novel food on the terms below has been submitted. It is for ministers in England and to decide whether to authorise the modification of use of the novel food. 

12.3 Introduction 

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. 

12.4 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.  

12.5 Any Relevant Provisions of assimilated law 

• Assimilated Regulation 2017/2469 laying down administrative and scientific requirements for applications: https://www.legislation.gov.uk/eur/2017/2469/contents   

• Assimilated Regulation 2015/2283 on the procedure for authorising the placing on the mahttps://www.legislation.gov.uk/eur/2015/2283/contents    

• Assimilated Regulation 1169/2011 on the provision of food information to consumers: https://www.legislation.gov.uk/eur/2011/1169

12.6 Terms of Authorisation (ToA)

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. The proposed terms of authorisation for that new novel food, including the additional use sought in this application are set out below:

Lacto-N-tetraose (‘LNT’) (produced by a derivative strain of Escherichia coli K-12 (DH1))

Conditions of use

Specified food category	Maximum levels
Beverages (flavoured drinks)	1.0 g/l
Cereal bars	10 g/kg
Flavoured fermented milk-based products including heat-treated products	1.0 g/l (beverages); 10 g/kg (products other than beverages)
Follow-on formula as defined in Regulation 609/2013	0.6 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Food for special medical purposes as defined in Regulation 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended
Infant formula as defined in Regulation 609/2013	0.8 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Milk-based drinks and similar products intended for young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	0.6 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer; 5 g/kg (products other than beverages)
Processed cereal-based food and baby food for infants and young children as defined in Regulation 609/2013	0.6 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer; 5 g/kg (products other than beverages)
Total diet replacement foods for weight control as defined in Regulation 609/2013	2.0 g/l (beverages); 20 g/kg (products other than beverages)
Unflavoured fermented milk-based products	1.0 g/l (beverages); 10 g/kg (products other than beverages)
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products	1.0 g/l
Food supplements as defined in the Food Supplements (England) Regulations 2003 and Food Supplements (Wales) Regulations 2003 for infants (persons under the age of 1 year (12 months))	0.8 g/day for persons up to 6 months of age; 0.6 g/day for persons over 6 months of age
Food supplements as defined in the Food Supplements (England) Regulations 2003 and Food Supplements (Wales) Regulations 2003 excluding food supplements for infants (persons under the age of 1 year (12 months))	2.0 g/day

Additional specific labelling requirements

• The designation of the novel food on the labelling of the food containing it is ‘lacto-N-tetraose’.
• The labelling of food supplements containing lacto-N-tetraose must bear a statement that the supplements should not be consumed if other foods containing added lacto-N-tetraose are consumed the same day.
• The labelling of food supplements containing lacto-N-tetraose intended for infants and young children must bear a statement that the supplements should not be consumed if breast milk or food with added lacto-N-tetraose is consumed on the same day.
• The food information must be presented in accordance with the provisions of Regulation 1169/2011 which apply to mandatory food information.

12.7 Specification 

There are no substantive changes to the specification proposed. 

https://data.food.gov.uk/regulated-products/novel_authorisations/novel-81 

12.8 Proposed Uses 

The novel food is intended for use in the food categories specified in the Terms of Authorisation (TOA) table above. The application seeks authorisation of Lacto-N-tetraose (‘LNT’) (produced by a derivative strain of Escherichia coli K-12 (DH1)) for use in infant supplements in Great Britain. 

The novel food is intended for the general population, including infants and young children, across a wide range of food categories, including dairy products, infant and follow-on formula, baby foods, drinks, foods for special medical purposes and food supplements. The proposed food categories and use levels are aligned with existing GB authorisations for LNT, where the key change being the extension to allow its use in food supplements for infants. 

12.9 Supplementary Information 

N/A  

12.10 Labelling 

Article 9(3)(b) of assimilated Regulation (EU) 2015/2283 provides that an authorisation of a novel food should include additional specific labelling requirements. 

Our proposed additional specific labelling requirements are as below: 

• The designation of the novel food on the labelling of the food containing it is ‘Lacto-N-tetraose’.  

• The labelling of food supplements containing Lacto-N-tetraose must bear a statement that they should not be consumed if other foods containing added Lacto-N-tetraose are consumed the same day. 

• The labelling of food supplements containing Lacto-N-tetraose intended for infants and young children must bear a statement that they should not be consumed if breast milk or food with added lacto-N-tetraose is consumed on the same day.  

https://www.legislation.gov.uk/eur/2011/1169/contentsLabels must follow all general food law requirements and supplements must additionally follow the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003 requirements. 

12.11 Transitional Requirements / Provisions 

N/A 

12.12 Further Explanation / Rationale 

N/A 

12.13 Post Market Monitoring 

N/A 

12.14 Definitions 

• ‘Infant’ means a child under the age of 12 months, as defined by Article 2(2)(a) of assimilated Regulation 609/2013. 

• ‘Young child’ means a child aged between 1 year (12 months) and 3 years (36 months), as defined by Article 2(2)(b) of assimilated Regulation 609/2013. 

• “Food supplements” are defined in the  Food Supplements (England) Regulations 2003; and the Food Supplements (Wales) Regulations 2003. 

12.15 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. 

12.16 Impacts  

As part of the risk analysis process, FSA has assessed the potential impacts that would result from the authorisation of this novel food, should ministers decide to authorise. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

12.17 Trade  

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

12.18 EU 

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

Lacto‐N‐tetraose (LNT) is already approved for use in the EU. 

Apart from 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 .   

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.  

12.19 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.   

12.20 Risk Management Recommendation 

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

13. Annex M: RP 2101

13.1 Risk Management Recommendation 

13.2 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)  

An application for the authorisation of a novel food for use in GB on the terms below has been submitted. It is for ministers in England and Wales to decide whether to authorise the use of this novel food. 

13.3 Introduction 

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. 

13.4 Safety Assessment Summary 

The FSA has undertaken the assessment of Lacto‑N‑tetraose (LNT) (produced by derivative strains of Escherichia coli BL21(DE3) and concluded that the novel food is safe under the new proposed conditions of use and does not pose a safety risk to human health. The anticipated intake level and the proposed use in food and food supplements was not considered to be nutritionally disadvantageous. 

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 

13.5 Any Relevant Provisions of assimilated law 

• Assimilated Regulation 2017/2469 laying down administrative and scientific requirements for applications: https://www.legislation.gov.uk/eur/2017/2469/contents   

• Assimilated Regulation 2015/2283 on the procedure for authorising the placing on the market of a novel food and updating the list: https://www.legislation.gov.uk/eur/2015/2283/contents    

• Assimilated Regulation 1169/2011 on the provision of food information to consumers: https://www.legislation.gov.uk/eur/2011/1169

13.6 Terms of Authorisation (ToA)

The proposed terms of authorisation are set out below:

Lacto-N-tetraose (LNT) produced by derivative strains of Escherichia coli BL21(DE3)

Conditions of use

Specified food category	Maximum Levels
Infant formula as defined in Regulation 609/2013	1.82 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Follow-on formula as defined in Regulation 609/2013	1.82 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based food and baby food for infants and young children as defined in Regulation 609/2013	1.82 g/kg (for products other than beverages); 1.82 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Milk-based drinks and similar products intended for young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	1.82 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Foods for special medical purposes as defined in Regulation 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended
Food supplements as defined in the Food Supplements (England) Regulations 2003 and Food Supplements (Wales) Regulations 2003 for infants (persons under the age of 1 year (12 months) and young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	1.82 g/day
Food supplements as defined in the Food Supplements (England) Regulations 2003 and Food Supplements (Wales) Regulations 2003 excluding food supplements for infants (persons under the age of 1 year (12 months) and young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	4.6 g/day

Additional specific labelling requirements

1. The designation of the novel food on the labelling of the food containing it is ‘Lacto-N-tetraose’.
2. The labelling of food supplements containing Lacto-N-tetraose must bear a statement that the supplements should not be consumed if other food with added Lacto-N-tetraose is consumed on the same day.
3. The labelling of food supplements for infants and young children must bear a statement that the supplements should not be consumed if breast milk or other food with added Lacto-N-tetraose is consumed on the same day.

The food information must be presented in accordance with the provisions of Regulation 609/2013 which apply to mandatory food information.

Data protection

This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation 2015/2283.

Applicant: Chr. Hansen A/S Boege Allé, 10-12 2970 Hoersholm, Denmark.

During the period of data protection, Lacto-N-tetraose (LNT) produced by derivative strains of Escherichia coli BL21(DE3) is authorised for placing on the market, within Great Britain, only by Chr. Hansen A/S unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation 2015/2283 or with the agreement of Chr. Hansen A/S.

The data protection will expire at the end of [5 years after authorisation date] (tbc).

13.7 Specification

Description

The novel food is a purified white to ivory powder composed of ≥ 75.0% w/w dry matter (DM) of Lacto-N-tetraose (LNT).

Source

Two derivative strains (a production strain and an optional degradation strain) of Escherichia coli BL21(DE3)

Definition

Chemical formula: C26H45NO21

Chemical name: β-D-Galactopyranosyl-(1→3)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose

CAS number: 14116-68-8

Molecular weight: 707.63 Da

Characteristics/Composition

Parameter	Specification
Lacto-N-tetraose	≥ 75.0% w/w dry matter
D-lactose	≤ 5.0% w/w dry matter
D-galactose and D-glucose	≤ 5.0% w/w dry matter
Lacto-N-triose II	≤ 5.0% w/w dry matter
para-lacto-N-hexaose	≤ 5.0% w/w dry matter
*Sum of other carbohydrates	≤ 15% w/w dry matter
Residual protein	≤ 0.01% w/w
Water	≤ 9.0% w/w

Ash	≤ 1.0% w/w

Heavy metals and contaminants

Parameter	Specification
Arsenic	≤ 0.2 mg/kg
Aflatoxin M1	≤ 0.025 µg/kg

Microbiological Criteria

Parameter	Specification
Standard plate count	≤ 1,000 CFU/g
Yeast and mould	≤ 100 CFU/g
Residual Endotoxins	≤ 10 EU/mg
Enterobacteriaceae	≤ 10 CFU/g
Salmonella spp.	Absent in 25g
Cronobacter spp.	Absent in 10g

• Sum of other carbohydrates (% w/w dry matter) = 100 (% w/w dry matter) – LNT (% w/w dry matter) – Quantified carbohydrates (% w/w dry matter) – Ash (% w/w dry matter).

CFU: Colony Forming Units.

EU: Endotoxin Units.

13.8 Proposed Uses 

The novel food is intended for use in the food categories specified in the Terms of Authorisation (TOA) table above. 

13.9 Supplementary Information 

N/A  

13.10 Labelling 

Article 9(3)(b) of assimilated Regulation (EU) 2015/2283 provides that an authorisation of a novel food should include additional specific labelling requirements. 

Our proposed additional specific labelling requirements are as below: 

• The designation of the novel food on the labelling of food containing it is ‘Lacto-N-tetraose’.  

• The labelling of food supplements containing Lacto-N-tetraose must bear a statement that the supplements should not be consumed if other food with added Lacto-N-tetraose is consumed on the same day. 

• The labelling of food supplements for infants and young children must bear a statement that they should not be consumed if breast milk or other food with added Lacto-N-tetraose is consumed on the same day.  

https://www.legislation.gov.uk/eur/2011/1169/contents 

Labels must follow all general food law requirements and supplements must additionally follow the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003 requirements. 

13.11 Transitional Requirements / Provisions  

N/A 

13.12 Further Explanation / Rationale 

N/A 

13.13 Post Market Monitoring 

N/A 

13.14 Definitions 

• ‘Infant’ means a child under the age of 12 months, as defined by Article 2(2)(a) of assimilated Regulation 609/2013. 

• ‘Young child’ means a child aged between 1 year (12 months) and 3 years (36 months), as defined by Article 2(2)(b) of assimilated Regulation 609/2013. 

• “Food supplements” are defined in the  Food Supplements (England) Regulations 2003; and Food Supplements (Wales) Regulations 2003. 

13.15 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. 

13.16 Impacts  

As part of the risk analysis process, FSA has assessed the potential impacts that would result from the authorisation of this novel food, should ministers decide to authorise. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

13.17 Trade  

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

13.18 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. 

13.19 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. 

13.20 Risk Management Recommendation 

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.

14. Annex N: RP 1752

14.1 Risk Management Recommendation 

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

An application for the modification of use in Great Britain of the authorised novel food on the terms below has been submitted. It is for ministers in England and Wales to decide whether to authorise the modification of use of the novel food. 

14.3 Introduction 

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 and authorise a new novel food, Lacto-N-neotetraose (LNnT) (produced by a derivative strain of Escherichia coli K‑12), 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. 

14.4 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. 

14.5 Any Relevant Provisions of assimilated law 

• Assimilated Regulation 2017/2469 laying down administrative and scientific requirements for applications: https://www.legislation.gov.uk/eur/2017/2469/contents   

• Assimilated Regulation 2015/2283 on the procedure for authorising the placing on the market of a novel food and updating the list: https://www.legislation.gov.uk/eur/2015/2283/contents    

• Assimilated Regulation 1169/2011 on the provision of food information to consumers: https://www.legislation.gov.uk/eur/2011/1169

14.6 Terms of Authorisation (ToA) 

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), with a separate specification. The proposed terms of authorisation for that new novel food, including the additional use sought in this application and removal of the reference to the ratio with 2’-FL are set out below:

Lacto-N-neotetraose (LNnT) (produced by a derivative strain of Escherichia coli K-12)

Conditions of use

Specified Food category	Maximum levels
Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation 828/2014	30 g/kg
Cereal bars	6 g/kg
Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products	4.8 g/l the maximum level refers to the products ready to use
Dairy analogues, including beverage whiteners	0.6 g/l (beverages); 6 g/kg (products other than beverages); 200 g/kg (whitener)
Flavoured drinks	0.6 g/l
Flavoured fermented milk-based products including heat-treated products	0.6 g/l (beverages); 9.6 g/kg (products other than beverages)
Follow-on formula as defined in Regulation 609/2013	0.6 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Food supplements as defined in the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003 excluding food supplements for infants (persons under the age of 1 year (12 months) and young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	1.5 g/day
Food supplements as defined in the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003 for infants (persons under the age of 1 year (12 months)) and young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	0.6 g/day
Foods for special medical purposes as defined in Regulation 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended
Infant formula as defined in Regulation 609/2013	0.6 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Milk-based drinks and similar products intended for young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))	0.6 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based food and baby food for infants and young children as defined in Regulation 609/2013	6.0 g/kg (for products other than beverages); 0.6 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer
Table-top sweeteners	100 g/kg
Total diet replacement for weight control as defined in Regulation 609/2013	2.4 g/l (beverages); 20 g/kg (products other than beverages)
Unflavoured fermented milk-based products	0.6 g/l (beverages); 9.6 g/kg (products other than beverages)
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk-based products	0.6 g/l

Additional specific labelling requirements

1. The designation of the novel food on the labelling of the food(s) containing it, is ‘Lacto-N-neotetraose’.
2. The labelling of food supplements containing Lacto-N-neotetraose must bear a statement that the supplements should not be consumed if other food with added Lacto-N-neotetraose is consumed on the same day.
3. The labelling of food supplements for infants and young children must bear a statement that the supplements should not be consumed if breast milk or other foods containing Lacto-N-neotetraose is consumed on the same day.

The food information must be presented in accordance with the provisions of Regulation No 1169/2011 which apply to mandatory food information.

14.7 Specification 

There are no substantive changes to the specification proposed. 

14.8 Proposed Uses 

The novel food is intended for use in the food categories specified in the Terms of Authorisation (TOA) table above. It is proposed to extend the original uses of the novel food, to be used in food supplements for infants (persons under the age of 1 year (12 months).  

14.9 Supplementary Information  

N/A  

14.10 Labelling 

Article 9(3)(b) of assimilated Regulation (EU) 2015/2283 provides that an authorisation of a novel food should include additional specific labelling requirements. 

Our proposed additional specific labelling requirements are as below: 

• The designation of the novel food on the labelling of the food(s) containing it, is “Lacto-N-neotetraose”. 

• The labelling of food supplements for infants and young children containing Lacto-N-neotetraose must bear a statement that they should not be used if breast milk or other foods containing added Lacto-N-neotetraose are consumed the same day. 

• The applicant requested the labelling: “Food supplements containing lacto-N-neotetraose must bear a statement that the food supplement should not be given to infants, and young children where they consume breast milk or other foods with added Lacto-N-neotetraose within the same twenty-four-hour period”, however, this is redundant given the additional labelling requirements we are proposing are stipulating the same requirements. We have proposed different wording to maintain consistency with previous authorisations; however, they are intended to have the same effect. 

Labels must follow all general food law requirements and supplements must additionally follow the requirements of Food Supplements (England) Regulations 2003; and Food Supplements (Wales) Regulations 2003. 

https://www.legislation.gov.uk/eur/2011/1169/contents 

14.11 Transitional Requirements / Provisions  

N/A 

14.12 Further Explanation / Rationale 

N/A 

14.13 Post Market Monitoring 

N/A 

14.14 Definitions 

• ‘Infant’ means a child under the age of 12 months, as defined by Article 2(2)(a) of assimilated Regulation 609/2013. 

• ‘Young child’ means a child aged between 1 year (12 months) and 3 years (36 months), as defined by Article 2(2)(b) of assimilated Regulation 609/2013. 

• “Food supplements” are defined in the Food Supplements (England) Regulations 2003; and the Food Supplements (Wales) Regulations 2003. 

14.15 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. 

14.16 Impacts  

As part of the risk analysis process, FSA has assessed the potential impacts that would result from the authorisation of this novel food, should ministers decide to authorise. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

14.17 Trade  

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

14.18 EU 

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

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

14.19 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.   

14.20 Risk Management Recommendation 

The FSA risk management recommendation is the conditions of use of Lacto-N-neotetraose (LNnT) (produced by a derivative strain of Escherichia coli K‑12) 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.

15. Annex O: RP 2213

15.1 Risk Management Recommendation 

15.2 RP2213 - Astaxanthin-rich oleoresin from Haematococcus ⁠pluvialis algae used as a novel food (modification of specification and conditions of use) 

An application for the modification of the specification and conditions of use in GB of this authorised novel food on the terms below has been submitted. It is for ministers in England and Wales to decide whether to authorise the modification of the specification and conditions of use for this novel food. 

15.3 Introduction 

An application was received by the FSA from AstaReal AB (Sweden) to modify the specifications and conditions of use for the authorised novel food Aastaxanthin (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. 

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 14 years (excluding infants and young children).   

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. 

15.4 Safety Assessment Summary 

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. 

15.5 Any Relevant Provisions of assimilated law 

• Assimilated Regulation 2017/2469 laying down administrative and scientific requirements for applications: https://www.legislation.gov.uk/eur/2017/2469/contents   

• Assimilated Regulation 2015/2283 on the procedure for authorising the placing on the market of a novel food and updating the list: https://www.legislation.gov.uk/eur/2015/2283/contents    

• Assimilated Regulation 1169/2011 on the provision of food information to consumers: https://www.legislation.gov.uk/eur/2011/1169

15.6 Terms of Authorisation (ToA)

The proposed terms of authorisation are set out below:

Astaxanthin-rich oleoresin from Haematococcus pluvialis algae

Conditions of use

Specified Food Category	Maximum Levels
Food supplements as defined in the Food Supplements (England) Regulations 2003 and Food Supplements (Wales) Regulations 2003 excluding infants (persons under the age of 1 year (12 months)), and young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months)), children, and adolescents younger than 14 years	40 – 80 mg/day of oleoresin, resulting in ≤8 mg astaxanthin per day

Additional Specific Labelling Requirements

• The designation of the novel food on the labelling of food containing it is ‘Astaxanthin’.
• The labelling of food supplements containing Astaxanthin-rich oleoresin from Haematococcus pluvialis algae must bear a statement that the supplements should not be consumed by infants, children, and adolescents younger than 14 years.
• The food information must be presented in accordance with the provisions of Regulation 1169/2011 which apply to mandatory food information.

15.7 Specification

Description/Definition

Astaxanthin is a carotenoid produced by Haematococcus pluvialis algae. Production methods for the growth of the algae are variable; using either closed systems exposed to sunlight or strictly controlled illuminated light; alternatively open ponds may be used. The algal cells are harvested and dried; the oleoresin is extracted using either super critical CO2 or a solvent (ethyl acetate). The Astaxanthin is diluted and standardised to 2,5 %, 5,0 %, 7,0 %, 10 %, 15 % or 20 % using olive oil, safflower oil, Sunflower oil or MCT (Medium Chain Triglycerides).

Composition of the Oleoresin

Parameter	Specification
Fat	42.2 - 99 %
Protein	≤ 4.4 %
Carbohydrate	≤ 52.8 %
Fibre	< 1.0 %
Ash	≤ 4.2 %

Specification of Carotenoids w/w%

Parameter	Specification
Total Astaxanthins	2.9 - 11.1 %
9-cis-astaxanthin	0.3 - 30.0 %
13-cis-astaxanthin	0.2 - 7.0 %
Astaxanthin monoesters	66.7 - 91.5 %
Astaxanthin diesters	0.16 - 32.5 %
Β-Carotene	0.01 - 0.3 %
Lutein	≤ 1.8 %
Canthaxanthin	≤ 1.30 %

Microbiological criteria

Parameter	Specification
Total aerobic bacteria	< 3000 CFU/g
Yeast and Moulds	< 100 CFU/g
Coliforms	< 10 CFU/g
Escherichia coli	Negative
Salmonella	Negative
Staphylococcus	Negative

CFU: Colony Forming Units.

15.8 Proposed Uses 

The novel food is intended for use in the food categories specified in the Terms of Authorisation (TOA) table above.  

15.9 Supplementary Information  

N/A  

15.10 Labelling 

Article 9(3)(b) of assimilated Regulation (EU) 2015/2283 provides that an authorisation of a novel food should include additional specific labelling requirements. 

Our proposed additional specific labelling requirements are as below: 

• The labelling of food supplements containing Astaxanthin-rich oleoresin from Haematococcus pluvialis algae must bear a statement that they should not be consumed by infants, children, and adolescents younger than 14 years. 

https://www.legislation.gov.uk/eur/2011/1169/contentsLabels must follow all general food law requirements and supplements must additionally follow The Food Supplements (England) Regulations 2003 and The Food Supplements (Wales) Regulations 2003. 

15.11 Transitional Requirements / Provisions  

N/A 

15.12 Further Explanation / Rationale 

N/A 

15.13 Post Market Monitoring 

N/A 

15.14 Definitions 

• Food supplements – as defined in The Food Supplements (England) Regulations 2003 and The Food Supplements (Wales) Regulations 2003.    

• ‘Infant’ means a child under the age of 12 months, as defined by Article 2.2(a) of  Regulation (EU) No 609/2013. 

• ‘Young child’ means a child aged between 1 year (12 months) and 3 years (36 months), as defined by Article 2.2(b) of assimilated Regulation (EU) No 609/2013. 

15.15 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 will consider as part of their decision on authorisation. The FSA has not identified any applicable other legitimate factors to date that would prevent authorisation or affect the conditions of authorisation of this novel food. As noted above, 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.

The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector.

15.16 Impacts  

As part of the risk analysis process, FSA has assessed the potential impacts that would result from the authorisation of this novel food, should ministers decide to authorise. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

15.17 Trade 

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

15.18 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). 

15.19 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise Aastaxanthin (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.   

15.20 Risk Management Recommendation 

The FSA risk management recommendation is that the modification of the conditions of use and of the specification 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.

16. Annex P: RP 2180

16.1 Risk Management Recommendation 

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

An application for the modification of the specification in GB of this authorised novel food on the terms below has been submitted. It is for ministers in England and Wales to decide whether to authorise the modification of the specification of this novel food. 

16.3 Introduction 

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. 

16.4 Safety Assessment Summary 

The FSA assessed the proposed modification to reduce the minimum DHA in the specification from ≥22.5% to ≥15.0% for Schizochytrium sp. oil rich in DHA and EPA. As the change relates only to specification and does not affect the overall composition, toxicology, or authorised uses, a full data set was not required. 

Evidence provided shows that, while the DHA:EPA ratio changes, the overall fatty acid profile and wider composition remain comparable, with no new safety concerns identified. Existing toxicological conclusions and intake thresholds remain applicable. 

The FSA concluded that the modification is safe under the current conditions of use and is not nutritionally disadvantageous. 

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 

16.5 Any Relevant Provisions of assimilated law 

• Assimilated Regulation 2017/2469 laying down administrative and scientific requirements for applications: https://www.legislation.gov.uk/eur/2017/2469/contents   

• Assimilated Regulation 2015/2283 on the procedure for authorising the placing on the market of a novel food and updating the list: https://www.legislation.gov.uk/eur/2015/2283/contents    

• Assimilated Regulation 1169/2011 on the provision of food information to consumers: https://www.legislation.gov.uk/eur/2011/1169 

16.6 Terms of Authorisation (ToA) 

The existing conditions of use for this application are unaffected by the proposed changes to the specification.  https://data.food.gov.uk/regulated-products/novel_authorisations/novel-129

16.7 Specification

Parameter	Specification
Acid Value	≤ 0.5 mg KOH/g
Peroxide Value (PV)	≤ 5.0 mEq/kg of oil
Oxidative stability	All food products containing Schizochytrium sp. oil rich in DHA and EPA should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC)
Moisture and Volatiles	≤ 0.05%
Unsaponifiables	≤ 4.5%
Trans-fatty Acids	≤ 1%
DHA Content	≥ 15%
EPA Content	≥ 10%

16.8 Proposed Uses 

The novel food is intended for use in the food categories specified in the Terms of Authorisation (TOA) table above.  

16.9 Supplementary Information  

N/A  

16.10 Labelling 

Article 9(3)(b) of assimilated Regulation (EU) 2015/2283 provides that an authorisation of a novel food should include additional specific labelling requirements. 

Our proposed additional specific labelling requirements are as below: 

• The labelling of food supplements containing Astaxanthin-rich oleoresin from Haematococcus pluvialis algae must bear a statement that they should not be consumed by infants, children, and adolescents younger than 14 years. 

https://www.legislation.gov.uk/eur/2011/1169/contentsLabels must follow all general food law requirements and supplements must additionally follow The Food Supplements (England) Regulations 2003 and The Food Supplements (Wales) Regulations 2003. 

16.11 Transitional Requirements / Provisions  

N/A 

16.12 Further Explanation / Rationale 

N/A 

16.13 Post Market Monitoring 

N/A 

16.14 Definitions 

• Food supplements – as defined in The Food Supplements (England) Regulations 2003 and The Food Supplements (Wales) Regulations 2003.    

• ‘Infant’ means a child under the age of 12 months, as defined by Article 2.2(a) of  Regulation (EU) No 609/2013. 

• ‘Young child’ means a child aged between 1 year (12 months) and 3 years (36 months), as defined by Article 2.2(b) of assimilated Regulation (EU) No 609/2013. 

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 will consider as part of their decision on authorisation. The FSA has not identified any applicable other legitimate factors to date that would prevent authorisation or affect the conditions of authorisation of this novel food. As noted above, 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.

The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector.  

16.15 Impacts  

As part of the risk analysis process, FSA has assessed the potential impacts that would result from the authorisation of this novel food, should ministers decide to authorise. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of these products should generally result in greater market competition, supporting growth and innovation in the sector. 

16.16 Trade 

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

16.17 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). 

16.18 Northern Ireland 

This novel food is already authorised in Northern Ireland. The FSA’s recommendation to authorise Aastaxanthin (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.   

16.19 Risk Management Recommendation 

The FSA risk management recommendation is that the modification of the conditions of use and of the specification 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.