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

Abstract

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.

Keywords

• 3’‐Sialyllactose
• 3’‐SL
• human milk oligosaccharide
• HMO
• HiMO
• novel food