Commission authorizes 2’-Fucosyllactose produced by a derivative strain of Escherichia coli W as a novel food

On July 29, 2024, the European Commission (EC) authorized the placing on the market of 2’-Fucosyllactose produced by a derivative strain of Escherichia coli W (ATCC 9637) 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, scientific studies and data from the NMR, LC-MS/MS, and HPLC-PAD tests for the determination of the identity of 2′-FL; the description of the genetically modified production strain of E. coli W (ATCC 9637) including its genome sequence and antimicrobial susceptibility studies; the detailed description of the production process including the raw materials and processing aids used; the compositional analyses data and the stability studies of the novel food; the bacterial reverse mutation test with 2′-FL; the in vitro mammalian cell micronucleus test with 2′-FL; the in vivo mammalian cell micronucleus test with 2′-FL; the 90-day oral toxicity study in rats with 2′-FL; and, the bioinformatics analysis study on the genome of the E. coli W (ATCC 9637) to detect heterologous sequences that could encode possible allergens, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place 2′-FL produced with a derivative strain of E. coli W (ATCC 9637) 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 2′-FL produced with a derivative strain of E. coli W (ATCC 9637) and the reference to the scientific data contained in the applicant’s file for their sole use by them 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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