Commission Implementing Regulation (EU) 2024/2036 of 29 July 2024 authorising 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

1 2′-Fucosyllactose obtained by microbial fermentation using a derivative strain of Escherichia coli (‘E. coli’) W (ATCC 9637) is authorised to be placed on the market within the Union. 2′-Fucosyllactose obtained by microbial fermentation using a derivative strain of E. coli W (ATCC 9637) shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

2 The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Only the company Kyowa Hakko Bio Co., Ltd is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 19 August 2024, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of Kyowa Hakko Bio Co., Ltd.

The scientific studies and data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of Kyowa Hakko Bio Co., Ltd.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.