Safety of 2′‐fucosyllactose (2’‐FL) produced by a derivative strain (Escherichia coli SGR5) of E. coli W (ATCC 9637) as a Novel Food pursuant to Regulation (EU) 2015/2283
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch‐Ernst, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thiès, Sophia Tsabouri, Marco Vinceti, Jaime Aguilera, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Miguel Prieto Maradona, Rosangela Marchelli, Monika Neuhäuser‐Berthold, Carmen Peláez, Morten Poulsen, Josef Schlatter, Alexandros Siskos, Henk Van Loveren, Paolo Colombo, Estefanía Noriega Fernández, Helle Katrine Knutsen
Abstract
W (ATCC 9637). The information provided on the identity, manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant applies for the same use and use levels as already authorised for 2'-FL and included in the Union list of NFs, with the general population as target population. The Panel noted that the available intake estimate is not recent (2015) and based on a different database (2008-2010 UK data) than that used by EFSA. For this reason, the Panel decided to perform a new intake estimate according to the current EFSA approach. The Panel notes that the highest P95 daily intake of the NF from the use as food ingredient is higher than the estimated natural highest mean daily intake in breastfed infants and marginally higher in young children. The applicant also proposes to extend the use of 2'-FL in food supplements (FS) for infants at the use level of 1.2 g/day. The resulting estimated intake in infants from the proposed use in FS is within the natural intake of 2'-FL in breastfed infants. FS are not intended to be used if other foods with added 2'-FL or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use.