Safety of lacto‐N‐fucopentaose I/2’‐fucosyllactose (LNFP‐I/2’‐FL) mixture 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
K-12 DH1 (DSM 4235). The information provided on the identity, 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 formula (IF) and follow-on formula, foods for infants and toddlers, foods for special medical purposes and food supplements (FS). The target population is the general population. The anticipated daily intake of LNFP-I from use in IF is similar to the estimated natural mean highest daily intake in breastfed infants. Overall, the anticipated daily intake of LNFP-I from the NF as a food ingredient at the maximum proposed use levels is unlikely to exceed the intake level of breastfed infants on a body weight basis. The intake in breastfed infants on a body weight basis is expected to be safe also for other population groups. The anticipated 2'-FL intake is generally rather low. The use of the NF in FS is not intended if other foods with added NF components or human milk (for infants and young children) are consumed on the same day. The Panel concludes that the NF, a mixture of LNFP-I and 2'-FL, is safe under the proposed conditions of use.