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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 October 2023.

For the Commission

The President

Ursula VON DER LEYEN

( 1 ) OJ L 327, 11.12.2015, p. 1 .

( 2 ) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods ( OJ L 351, 30.12.2017, p. 72 ).

( 3 ) Commission Implementing Regulation (EU) 2021/2029 of 19 November 2021 authorising the placing on the market of 3-Fucosyllactose (3-FL) as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 ( OJ L 415, 22.11.2021, p. 9 ).

( 4 ) 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 ( OJ L 3, 5.1.2023, p. 1 ).

( 5 ) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 ( OJ L 181, 29.6.2013, p. 35 ).

( 6 ) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements ( OJ L 183, 12.7.2002, p. 51 ).

( 7 ) Glycom A/S 2021 and 2022 (unpublished).

( 8 ) Glycom A/S 2021 and 2022 (unpublished).

( 9 ) Glycom A/S 2021 and 2022 (unpublished).

( 10 ) Glycom A/S 2021 (unpublished).

( 11 ) Phipps KR, Lozon D, Stannard DR, Gilby B, Baldwin N, Miks MH, Lau A and Röhrig CH, 2022. Neonatal subchronic toxicity and in vitro genotoxicity studies of the human-identical milk oligosaccharide 3-fucosyllactose. Journal of Applied Toxicology, 2022, 1–17.

( 12 ) Phipps KR, Lozon D, Stannard DR, Gilby B, Baldwin N, Miks MH, Lau A and Röhrig CH, 2022. Neonatal subchronic toxicity and in vitro genotoxicity studies of the human-identical milk oligosaccharide 3-fucosyllactose. Journal of Applied Toxicology, 2022, 1–17.

( 13 ) Phipps KR, Lozon D, Stannard DR, Gilby B, Baldwin N, Miks MH, Lau A and Röhrig CH, 2022. Neonatal subchronic toxicity and in vitro genotoxicity studies of the human-identical milk oligosaccharide 3-fucosyllactose. Journal of Applied Toxicology, 2022, 1–17.

( 14 ) Phipps KR, Lozon D, Stannard DR, Gilby B, Baldwin N, Miks MH, Lau A and Röhrig CH, 2022. Neonatal subchronic toxicity and in vitro genotoxicity studies of the human-identical milk oligosaccharide 3-fucosyllactose. Journal of Applied Toxicology, 2022, 1–17.

( 15 ) EFSA Journal 2023;21(6):8026.

( 16 ) Address: Kogle Allé 4, 2970 Hørsholm, Denmark.

COMMISSION IMPLEMENTING REGULATION (EU) 2023/2210 of 20 October 2023 authorising the placing on the market of 3-Fucosyllactose produced by a derivative strain of ANNEX