The European Commission approved the extensions of use of the authorised novel foods (NFs) 2’-fucosyllactose (2’-FL) and lacto-N-neotetraose (LNnT) in fin food supplements (FS) for infants pursuant to Regulation (EU) 2015/2283. The NFs are produced by fermentation with genetically modified strains of Escherichia coli K-12 and already included in the EU list of NFs. The applicant stated that no changes in the production process or the identity of the NFs occurred. The applicant proposes an extension of use of the NF containing 2’-FL in FS intended for infants (< 1 year), at a maximum use level of 1.2 g/day. The applicant also proposes an extension of use of LNnT in FS intended for infants, at a maximum use level of 0.6 g/day. The intake of 2’-FL per kg body weight from the proposed maximum use levels in FS for infants is lower than the lowest estimated mean intake of naturally occurring 2’-FL from human milk. Similarly, the intake of LNnT per kg body weight is lower than the highest estimated mean intake of naturally occurring 2’-FL from human milk. Furthermore, the Panel notes that the proposed uses of 2’-FL in FS for infants are lower than the estimated intake from the already authorised uses of the NF for the same population group. The Panel also notes that the proposed uses of LNnT in FS for infants are similar to the estimated intake from the already authorised uses of the NF for the same population group. The Panel concludes that the use of the NFs containing 2’-FL or LNnT in FS for infants is safe under the proposed conditions of use.
Cf. Commission Implementing Regulation (EU) 2023/950 of 12 May 2023 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food 2’-Fucosyllactose.
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