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

Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Rosangela Marchelli, Monika Neuhäuser-BertholdMorten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Henk van Loveren, Paolo Colombo, Estefanía Noriega Fernández, Helle Katrine Knutsen, EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

Research output: Contribution to journalArticleResearch

2 Citations (Scopus)

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 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.

Original languageEnglish
Article numbere07331
JournalEFSA Journal
Volume20
Issue number5
DOIs
Publication statusPublished - May 2022

Keywords

  • 3’-sialyllactose
  • 3’-SL sodium salt
  • HiMO
  • HMO
  • human milk oligosaccharide
  • novel food
  • safety

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