Safety of 2′‐O‐fucosyllactose as a novel food ingredient pursuant to Regulation (EC) No 258/97
2015; Wiley; Volume: 13; Issue: 7 Linguagem: Inglês
10.2903/j.efsa.2015.4184
ISSN1831-4732
Tópico(s)Viral gastroenteritis research and epidemiology
ResumoEFSA JournalVolume 13, Issue 7 4184 OpinionOpen Access Safety of 2′-O-fucosyllactose as a novel food ingredient pursuant to Regulation (EC) No 258/97 EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)Search for more papers by this author EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)Search for more papers by this author First published: 20 July 2015 https://doi.org/10.2903/j.efsa.2015.4184Citations: 24 Panel members: Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen. Correspondence: [email protected] Acknowledgement: The Panel wishes to thank the members of the Working Group on Novel Foods: Paul Brantom, Karl-Heinz Engel, Marina Heinonen, Hannu Korhonen, Rosangela Marchelli, Bevan Moseley, Monika Neuhäuser-Berthold, Annette Pöting, Morten Poulsen, Seppo Salminen, Josef Schlatter, Hendrik Van Loveren and Hans Verhagen for the preparatory work on this scientific opinion. Adoption date: 29 June 2015 Published date: 20 July 2015 Question number: EFSA-Q-2015-00052 On request from: European Commission AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Abstract Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on 2′-O-fucosyllactose as a novel food ingredient (NFI) submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. 2′-O-fucosyllactose (2′-FL) is a synthetic trisaccharide, which is intended to be used in infant and follow-on formulae, foods for special medical purposes for infants and young children, and other foods for infants and young children, as well as in foods or food supplements for adults. The information provided on the potential mutagenicity of 2′-FL does not raise safety concerns as regards the genotoxicity of this NFI. Based on the observations from a sub-chronic 90-day toxicity study in rats, the Panel considers that the no observed adverse effect level is 2 000 mg/kg body weight per day. The applicant provided a double-blind, randomised, controlled clinical trial on the effects of 2'-FL consumed in combination with another oligosaccharide (lacto-N-neotetraose (LNnT)) in infants. The Panel concludes that 2'-FL is safe for infants (up to one year of age) when added to infant and follow-on formulae, in combination with LNnT, at concentrations up to 1.2 g/L of 2'-FL and up to 0.6 g/L of LNnT, at a ratio of 2:1 in the reconstituted formulae; is safe for young children (older than one year of age) when added to follow-on and young-child formulae, at concentrations up to 1.2 g/L of 2'-FL (alone or in combination with LNnT, at concentrations up to 0.6 g/L, at a ratio of 2:1). The Panel also concludes that 2'-FL is safe when added to other foods at the uses and use levels proposed by the applicant. 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