Commission Implementing Regulation (EU) 2023/52 of 4 January 2023 authorising the placing on the market of 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

1 3-Fucosyllactose produced with a derivative strain of E. coli BL21(DE3) is authorised to be placed on the market within the Union. 3-Fucosyllactose produced with a derivative strain of E. coli BL21(DE3) 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 Chr. Hansen A/S is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of five years from 25 January 2023, 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 Chr. Hansen A/S.

The scientific 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 Chr. Hansen A/S.

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