Commission authorizes Lacto-N-fucopentaose I and 2'-Fucosyllactose mixture produced by derivative strain of Escherichia coli K-12 DH1

On July 29, 2024, the European Commission (EC) authorized the placing on the market of Lacto-N-fucopentaose I and 2'-Fucosyllactose mixture produced using a derivative strain of Escherichia coli K-12 DH1 as a novel food and amending Implementing Regulation (EU) 2017/2470.

The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the scientific studies and data on the LC-MS and LC-MS/MS studies, the NMR study, and the HPLC-CAD method validation study and results for the determination of the identity of the LNFP-I/2'-FL mixture; a detailed description of the genetically modified LNFP-I/2'-FL mixture production strain and production strain certificates; raw material and processing aid specifications; a detailed description of the production process; detailed composition analyses; the results of the stability studies; the quantitative analyses of the levels of LNFP-I and of 2'-FL in human milk; the intake assessment of the LNFP-I/2'-FL mixture; a bacterial reverse mutation test with the LNFP-I/2'-FL mixture; an in vitro mammalian cell micronucleus test with the LNFP-I/2'-FL mixture; and, a 90-day oral toxicity study in rats with the LNFP-I/2'-FL mixture, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place the LNFP-I/2'-FL mixture produced using a derivative strain of E. coli K-12 DH1 on the market within the Union during a period of five years from the entry into force of this Regulation.

However, restricting the authorisation of the LNFP-I/2'-FL mixture produced using a derivative strain of E. coli K-12 DH1 and the reference to the scientific studies and data contained in the applicant’s file for its sole use does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food, provided that their application is based on legally obtained information supporting such an authorisation.

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