Open AccessSafety of 3’‐Sialyllactose (3’‐SL) sodium salt as a novel food pursuant to Regulation (EU) 2015/2283
Author(s) -
Turck Dominique,
Castenmiller Jacqueline,
De Henauw Stefaan,
HirschErnst Karen Ildico,
Kearney John,
Maciuk Alexandre,
Mangelsdorf Inge,
McArdle Harry J,
Naska Androniki,
Pelaez Carmen,
Pentieva Kristina,
Siani Alfonso,
Thies Frank,
Tsabouri Sophia,
Vinceti Marco,
Cubadda Francesco,
Engel Karl Heinz,
Frenzel Thomas,
Hein Marina,
Marchelli Rosangela,
NeuhäuserBerthold Monika,
Poulsen Morten,
Schlatter Josef Rudolf,
van Loveren Henk,
Colombo Paolo,
Knutsen Helle Katrine
Publication year - 2020
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2020.6098
Subject(s) - food science , population , infant formula , breast milk , food safety , lactose , european commission , medicine , environmental health , biology , microbiology and biotechnology , business , european union , biochemistry , economic policy
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 (Hi MO ) 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 DH 1. 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.