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Safety of 2'-fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283.
EFSA J. 2019 Jun; 17(6):e05717.EJ

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 2'-fucosyllactose/difucosyllactose (2'-FL/DFL) mixture as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a powdered mixture mainly composed of two oligosaccharides, 2'-FL and DFL, which are produced together by fermentation with a genetically modified strain of Escherichia coli K12. 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 young children, foods for special medical purposes and food supplements. The target population is the general population except for food supplements, for which the target population is individuals above 1 year of age. Since the intake of 2'-FL and DFL from the NF at the proposed use levels is unlikely to exceed the intake level of naturally occurring 2'-FL and DFL in breastfed infants per kilogram body weight, the Panel concludes that the NF, a mixture of 2'-FL and DFL, is safe under the proposed conditions of use for the proposed target population.

Authors

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Pub Type(s)

Journal Article

Language

eng

PubMed ID

32626339

Citation

EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), et al. "Safety of 2'-fucosyllactose/difucosyllactose Mixture as a Novel Food Pursuant to Regulation (EU) 2015/2283." EFSA Journal. European Food Safety Authority, vol. 17, no. 6, 2019, pp. e05717.
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck D, Castenmiller J, et al. Safety of 2'-fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283. EFSA J. 2019;17(6):e05717.
Turck, D., Castenmiller, J., De Henauw, S., Hirsch-Ernst, K. I., Kearney, J., Maciuk, A., Mangelsdorf, I., McArdle, H. J., Naska, A., Pelaez, C., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Cubadda, F., Engel, K. H., Frenzel, T., Heinonen, M., ... Knutsen, H. K. (2019). Safety of 2'-fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal. European Food Safety Authority, 17(6), e05717. https://doi.org/10.2903/j.efsa.2019.5717
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), et al. Safety of 2'-fucosyllactose/difucosyllactose Mixture as a Novel Food Pursuant to Regulation (EU) 2015/2283. EFSA J. 2019;17(6):e05717. PubMed PMID: 32626339.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety of 2'-fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283. AU - ,, AU - Turck,Dominique, AU - Castenmiller,Jacqueline, AU - De Henauw,Stefaan, AU - Hirsch-Ernst,Karen Ildico, AU - Kearney,John, AU - Maciuk,Alexandre, AU - Mangelsdorf,Inge, AU - McArdle,Harry J, AU - Naska,Androniki, AU - Pelaez,Carmen, AU - Pentieva,Kristina, AU - Siani,Alfonso, AU - Thies,Frank, AU - Tsabouri,Sophia, AU - Vinceti,Marco, AU - Cubadda,Francesco, AU - Engel,Karl Heinz, AU - Frenzel,Thomas, AU - Heinonen,Marina, AU - Marchelli,Rosangela, AU - Neuhäuser-Berthold,Monika, AU - Pöting,Annette, AU - Poulsen,Morten, AU - Sanz,Yolanda, AU - Schlatter,Josef Rudolf, AU - van Loveren,Henk, AU - Sun,Qingqing, AU - Turla,Emanuela, AU - Knutsen,Helle Katrine, Y1 - 2019/06/11/ PY - 2020/7/7/entrez PY - 2020/7/7/pubmed PY - 2020/7/7/medline KW - 2’‐FL KW - 2’‐fucosyllactose KW - DFL KW - difucosyllactose KW - novel food KW - oligosaccharide KW - safety SP - e05717 EP - e05717 JF - EFSA journal. European Food Safety Authority JO - EFSA J VL - 17 IS - 6 N2 - 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 2'-fucosyllactose/difucosyllactose (2'-FL/DFL) mixture as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a powdered mixture mainly composed of two oligosaccharides, 2'-FL and DFL, which are produced together by fermentation with a genetically modified strain of Escherichia coli K12. 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 young children, foods for special medical purposes and food supplements. The target population is the general population except for food supplements, for which the target population is individuals above 1 year of age. Since the intake of 2'-FL and DFL from the NF at the proposed use levels is unlikely to exceed the intake level of naturally occurring 2'-FL and DFL in breastfed infants per kilogram body weight, the Panel concludes that the NF, a mixture of 2'-FL and DFL, is safe under the proposed conditions of use for the proposed target population. SN - 1831-4732 UR - https://www.unboundmedicine.com/medline/citation/32626339/Safety_of_2'-fucosyllactose/difucosyllactose_mixture_as_a_novel_food_pursuant_to_Regulation_(EU)_2015/2283 L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/32626339/ DB - PRIME DP - Unbound Medicine ER -