Commission Implementing Regulation (EU) 2024/1047 of 9 April 2024 authorising the placing on the market of 3′-Sialyllactose sodium salt produced using a derivative strain of Escherichia coli W (ATCC 9637) as a novel food and amending Implementing Regulation (EU) 2017/2470

1 3′-Sialyllactose sodium salt produced using a derivative strain of Escherichia coli W (ATCC 9637) is authorised to be placed on the market within the Union. 3′-Sialyllactose sodium salt produced using a derivative strain of Escherichia 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 30 April 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 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 5 years from30 April 2024, 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.