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

et al. 2022

EFS2

Self Cite

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on 3'-sialyllactose (3'-SL) sodium salt as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) 3'-SL, but it also contains D-lactose, 3'-sialyllactulose, sialic acid, N-acetyl-D-glucosamine and a small fraction of other related oligosaccharides. The NF is produced by fermentation with two genetically modified strains of Escherichia coli BL21 (DE3), the production strain and the optional degradation strain. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF to a variety of foods, including infant formula and follow-on formula, food for infants and young children, food for special medical purposes and food supplements. The target population is the general population. The anticipated daily intake of 3'-SL from both proposed and combined (authorised and proposed) uses at their respective maximum use levels in all population categories does not exceed the highest intake level of 3'-SL from human milk in infants on a body weight basis. The intake of 3'-SL in breastfed infants on a body weight basis is expected to be safe also for other population groups. The intake of other carbohydrate-type compounds structurally related to 3'-SL is also considered of no safety concern. Food supplements are not intended to be used if other foods with added 3'-SL or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use.

Section: Introductionmentioning

confidence: 99%

Safety of 3’‐sialyllactose (3’‐SL) sodium salt produced by derivative strains of Escherichia coli BL21 (DE3) as a Novel Food pursuant to Regulation (EU) 2015/2283

Turck¹,

Bohn²,

et al. 2022

EFS2

Self Cite

“…3‐FL is included in the Union list of authorised novel foods (NFs) (Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 4 ) when produced by fermentation with a genetically modified strain of Escherichia coli K‐12 MG1655. Since 2015, several scientific opinions have been adopted by the EFSA NDA Panel on the safety of human‐identical milk oligosaccharides (HiMOs) as NFs pursuant to Regulation (EC) No 258/97 or Regulation (EU) 2015/2283: 2’‐fucosyllactose (2’‐FL) (EFSA NDA Panel, 2015a ), lacto‐N‐neotetraose (LNnT) (EFSA NDA Panel, 2015b ), LNnT and 2’‐FL in FS for children (EFSA NDA Panel, 2015c ), N‐acetyl‐ d ‐neuraminic acid (NANA) (EFSA NDA Panel, 2017 ), 2’‐FL/difucosyllactose (DFL) mixture (EFSA NDA Panel, 2019a ), lacto‐N‐tetraose (LNT) produced with a derivative strain of E. coli K‐12 DH1 (EFSA NDA Panel, 2019b ), 3’‐sialyllactose (3’‐SL) sodium salt (EFSA NDA Panel, 2020a ), 6’‐sialyllactose (6’‐SL) sodium salt (EFSA NDA Panel, 2020b ), LNnT produced with derivative strains of E. coli BL21 (DE3) (EFSA NDA Panel, 2020c ), 3‐FL produced with a derivative strain of E. coli K‐12 MG1655 (EFSA NDA Panel, 2021 ), 2’‐FL/DFL mixture and LNT in FS for infants (EFSA NDA Panel, 2022a ), 2’‐FL and LNnT in FS for infants (EFSA NDA Panel, 2022b ) and LNT produced with derivative strains of E. coli BL21 (DE3) (EFSA NDA Panel, 2022c ).…”

Section: Introductionmentioning

confidence: 99%

Safety of 3‐fucosyllactose (3‐FL) produced by a derivative strain of Escherichia coli BL21 (DE3) as a Novel Food pursuant to Regulation (EU) 2015/2283

Turck¹,

Bohn²,

et al. 2022

EFS2

Self Cite

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on 3-fucosyllactose (3-FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) 3-FL, but it also contains D-lactose, L-fucose, D-glucose and D-galactose, and a small fraction of other related saccharides. The NF is produced by fermentation with a genetically modified strain of Escherichia coli BL21 (DE3). The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF to a variety of foods, including infant formula and follow-on formula, food for infants and young children, food for special medical purposes and food supplements. The target population is the general population. The anticipated daily intake of 3-FL from both proposed and combined (authorised and proposed) uses at their respective maximum use levels in all population categories does not exceed the highest intake level of 3-FL from human milk in infants on a body weight basis. The intake of 3-FL in breastfed infants on a body weight basis is expected to be safe also for other population groups. The intake of other carbohydrate-type compounds structurally related to 3-FL is also considered of no safety concern. Food supplements are not intended to be used if other foods with added 3-FL or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use.

“…Since 2015, several scientific opinions have been adopted by the EFSA NDA Panel on the safety of human‐identical" milk oligosaccharides (HiMOs) as NFs pursuant to Regulation (EC) No 258/97 or Regulation (EU) 2015/2283: Chemically synthetised 2′‐fucosyllactose (2’‐FL) (EFSA NDA Panel, 2015a ); Chemically synthetised lacto‐N‐neotetraose (LNnT) (EFSA NDA Panel, 2015b ) and LNnT produced with derivative strains of E. coli BL21 (DE3) (EFSA NDA Panel, 2020c ); Extension of use in food supplements (FS) for infants of chemically synthetised 2’‐FL and LNnT (EFSA NDA Panel, 2015c ) or 2’‐FL and LNnT produced with derivative strains of E. coli K‐12 DH1 (EFSA NDA Panel, 2022b ); Chemically synthetised N‐acetyl‐ d ‐neuraminic acid (NANA) (EFSA NDA Panel, 2017 ); 2’‐FL/difucosyllactose (DFL) mixture produced with a derivative strain of E. coli K‐12 DH1 (EFSA NDA Panel, 2019a ); Lacto‐N‐tetraose (LNT) produced with a derivative strain of E. coli K‐12 DH1 (EFSA NDA Panel, 2019b ) or with derivative strains of E. coli BL21 (DE3) (EFSA NDA Panel, 2022c ); Extension of use in FS for infants of 2’‐FL/DFL mixture and LNT produced with derivative strains of E. coli K‐12 DH1 (EFSA NDA Panel, 2022d ); 6’‐SL sodium salt produced with a derivative strain of E. coli K‐12 DH1 (EFSA NDA Panel, 2020a ); 3’‐SL sodium salt produced with a derivative strain of E. coli K‐12 DH1 (EFSA NDA Panel, 2020b ) or with derivative strains of E. coli BL21 (DE3) (EFSA NDA Panel, 2022a ); 3‐fucosyllactose (3‐FL) produced with a derivative strain of E. coli K‐12 MG1655 (EFSA NDA Panel, 2021 ) or with a derivative strain of E. coli BL21 (DE3) (EFSA NDA Panel, 2022e ). …”

Section: Introductionmentioning

confidence: 99%

“…Extension of use in food supplements (FS) for infants of chemically synthetised 2’‐FL and LNnT (EFSA NDA Panel, 2015c ) or 2’‐FL and LNnT produced with derivative strains of E. coli K‐12 DH1 (EFSA NDA Panel, 2022b );…”

Section: Introductionmentioning

confidence: 99%

Safety of 6′‐sialyllactose (6’‐SL) sodium salt produced by derivative strains of Escherichia coli BL21 (DE3) as a novel food pursuant to Regulation (EU) 2015/2283

Turck¹,

Bohn²,

et al. 2022

EFS2

Self Cite

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on 6′‐sialyllactose (6’‐SL) sodium salt as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human‐identical milk oligosaccharide (HiMO) 6’‐SL, but it also contains d ‐lactose, 6′‐sialyllactulose, sialic acid, N‐acetyl‐ d ‐glucosamine and a small fraction of other related oligosaccharides. The NF is produced by fermentation with two genetically modified strains of Escherichia coli BL21 (DE3), the production strain and the optional degradation strain. The information provided on the identity, manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF to a variety of foods, including infant formula and follow‐on formula, food for special medical purposes and food supplements. The target population is the general population. In some scenarios at the maximum use levels, the estimated intakes per kg body weight were higher than the high average natural intake of 6’‐SL from human milk. However, given the intrinsic nature of human milk oligosaccharides (HMOs), the wide range of intakes from human milk, and considering that infants are naturally exposed to similar amounts of these substances, the Panel considers that the consumption of the NF at the proposed conditions of use does not raise safety concerns. The intake of 6’‐SL in breastfed infants on a body weight basis is also expected to be safe for other population groups. The intake of other carbohydrate‐type compounds structurally related to 6’‐SL is also considered of no safety concern. Food supplements are not intended to be used if other foods with added 6’‐SL or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use.