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, 12 May 2023.

For the Commission

The President

Ursula VON DER LEYEN

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

( 2 ) Commission Implementing Regulation (EU) No 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 Decision (EU) 2016/375 of 11 March 2016 authorising the placing on the market of Lacto- N -neotetraose as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council ( OJ L 70, 16.3.2016, p. 22 ).

( 4 ) Regulation (EC) No 258/97 of the European Parliament and of the Council concerning novel food and novel food ingredients ( OJ L 43, 14.2.1997, p. 1 ).

( 5 ) Commission Implementing Regulation (EU) 2019/1314 of 2 August 2019 authorising the change of the specifications of the novel food Lacto- N -neotetraose produced with Escherichia coli K-12 under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 ( OJ L 205 5.8.2019, p. 4 ).

( 6 ) Commission Implementing Regulation (EU) 2021/912 of 4 June 2021 authorising changes in the specifications of the novel food Lacto- N -neotetraose (microbial source) and amending Implementing Regulation (EU) 2017/2470 ( OJ L 199, 7.6.2021, p.10 ).

( 7 ) 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 ).

( 8 ) EFSA Journal 2022; 207(5):7257.

( 9 ) 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 ).

COMMISSION IMPLEMENTING REGULATION (EU) 2023/961 of 12 May 2023 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food Lacto- ANNEX