Safety of 3’‐Sialyllactose (3’‐SL) sodium salt as a novel food pursuant to Regulation (EU) 2015/2283

Abstract

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 also containing D-lactose, sialic acid and a small fraction of other related oligosaccharides resulting in a fully characterised mixture of carbohydrates. The NF is produced by fermentation with a genetically modified strain of Escherichia coli K-12 DH1. 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 in a variety of foods, including infant and follow-on formula, foods for infants and toddlers, foods for special medical purposes and food supplements. The target population is the general population. The anticipated daily intake of 3'-SL from the NF at the maximum proposed use levels is unlikely to exceed the intake level of naturally occurring 3'-SL in breastfed 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 NF (as well as breast milk, milk, fermented milk-based products and selected cheeses retaining milk sugar (e.g. curd cheese) for infants and young children) are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use for the proposed target populations.

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

“…3’‐SL is the most represented oligosaccharide in bovine milk and its concentration is estimated to be ranging from 47 to 55 mg/L and over 1 g/L in bovine colostrum (Aldredge et al, 2013 ; Urashima et al, 2013 ; Albrecht et al, 2014 ). This is approximately six times lower than the respective concentration in human milk (EFSA NDA Panel, 2020a ).…”

“…The applicant also referred to the stability studies included in the GRAS (Generally Recognised As Safe) notifications GRN (GRAS Notice) 766 and GRN 880 (US FDA, 2019 , 2020 ) on 3’‐SL sodium salt produced by enzymatic synthesis or fermentation with a derivative strain of E. coli K‐12 DH1, respectively, as well as to the stability of the authorised NF for at least 24 months when stored at room temperature (EFSA NDA Panel, 2020a ). The applicant proposed a 1‐year shelf‐life from the date of production of the NF, when stored under ambient conditions.…”

“…No stability data for 3’‐SL sodium salt in other food matrices were provided. The NDA Panel concluded in its previous assessment of this HiMO that ‘the available data provide sufficient information with respect to the stability of the NF in the food matrices at neutral pH, when stored at room temperature under proper storage conditions’ (EFSA NDA Panel, 2020a ).…”

“…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 food supplements (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 produced with a derivative strain of E . coli K‐12 DH1 (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‐fucosyllactose (3‐FL) (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 ).…”

“…Sodium salts of 3’‐SL (EFSA NDA Panel, 2020a ) and 6’‐SL (EFSA NDA Panel, 2020b ), produced with derivative strains of E . coli K‐12 DH1, have been previously assessed by EFSA as NFs, with positive outcomes.…”