Commission Implementing Regulation (EU) 2023/65 of 6 January 2023 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods, Implementing Regulation (EU) 2018/1648 authorising the placing on the market of xylo-oligosaccharides as a novel food, Implementing Regulation (EU) 2019/1686 authorising the extension of use of bovine milk basic whey protein isolate as a novel food, and Implementing Regulation (EU) 2021/96 authorising the placing on the market of 3'-sialyllactose sodium salt as a novel food (Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Articles 8 and 12 thereof,

Whereas:

(1) Pursuant to Article 8 of Regulation (EU) 2015/2283, the Commission was to establish, by 1 January 2018, the Union list of novel foods authorised or notified under Regulation (EC) No 258/97 of the European Parliament and of the Council (2).

(2) The Union list of novel foods authorised or notified under Regulation (EC) No 258/97 was established by Commission Implementing Regulation (EU) 2017/2470 (3).

(3) The Commission has identified errors in the Annex to Implementing Regulation (EU) 2017/2470. Corrections are needed in order to provide clarity and legal certainty to food business operators and to the Member States’ competent authorities, thus ensuring the proper implementation and use of the Union list of novel foods.

(4) The conditions of use of the novel food ‘bovine milk basic whey protein isolate’, authorised by Commission Implementing Regulation (EU) 2018/1632 (4), were subsequently extended by Commission Implementing Regulation (EU) 2019/1686 (5). In Table 1 of the Annex to Implementing Regulation (EU) 2019/1686, the lines separating the specified food categories and the maximum authorised levels were erroneously omitted, thereby making unclear what food category corresponds to what authorised use. That might create confusion for enforcement authorities and the food business operators. Therefore, a correction of the Annex to Implementing Regulation (EU) 2019/1686 and Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

(5) The novel food ‘3'-Sialyllactose sodium salt (microbial source)’ was authorised by Commission Implementing Regulation (EU) 2021/96 (6). The maximum levels indicated for the food category ‘Flavoured fermented milk-based products including heat-treated products’ were erroneously added to the food category ‘Unflavoured fermented milk-based products’, and vice versa. Therefore, a correction of Table 1 of Annex to Implementing Regulation (EU) 2021/96 and Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

(6) The novel food ‘Galacto-oligosaccharide’ was authorised under certain conditions of use pursuant to Article 5 of Regulation (EC) No 258/97. The microbial source ‘Bacillus circulans’ of the enzyme ‘β-galactosidase’ used for the production of the Galacto-oligosaccharide was erroneously added to the specifications. Therefore, this source of β-galactosidase should be removed from the entry ‘Galacto-oligosaccharide’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470.

(7) The novel food ‘Xylo-oligosaccharide’ was authorised under certain conditions of use by Commission Implementing Regulation (EU) 2018/1648 (7), based on a favourable opinion on the safety of the novel food by the European Food Safety Authority (‘the Authority’). The specifications of the syrup form of ‘Xylo-oligosaccharide’ erroneously did not contain the parameter ‘dry material’ in the corresponding column. This error has been corrected in the revised scientific opinion of the Authority (8). Therefore, the specifications concerning ‘Xylo-oligosaccharide’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 and in the Annex to Implementing Regulation (EU) 2018/1648 should be corrected accordingly.

(8) Implementing Regulation (EU) 2017/2470, Implementing Regulation (EU) 2018/1648, Implementing Regulation (EU) 2019/1686 and Implementing Regulation (EU) 2021/96 should therefore be corrected accordingly.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2017/2470 is corrected in accordance with Annex I to this Regulation.

Article 2

Implementing Regulation (EU) 2018/1648 is corrected in accordance with Annex II to this Regulation.

Article 3

Implementing Regulation (EU) 2019/1686 is corrected in accordance with Annex III to this Regulation.

Article 4

Implementing Regulation (EU) 2021/96 is corrected in accordance with Annex IV to this Regulation.

Article 5

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, 6 January 2023.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 327, 11.12.2015, p. 1.

(2) Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

(3) 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).

(4) Commission Implementing Regulation (EU) 2018/1632 of 30 October 2018 authorising the placing on the market of bovine milk basic whey protein isolate 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 272, 31.10.2018, p. 23).

(5) Commission Implementing Regulation (EU) 2019/1686 of 8 October 2019 authorising the extension of use of bovine milk basic whey protein isolate 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 258, 9.10.2019, p. 13).

(6) Commission Implementing Regulation (EU) 2021/96 of 28 January 2021 authorising the placing on the market of 3'-sialyllactose sodium salt 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 31, 29.1.2021, p. 201).

(7) Commission Implementing Regulation (EU) 2018/1648 of 29 October 2018 authorising the placing on the market of xylo-oligosaccharides 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 275, 6.11.2018, p. 1).

(8) EFSA Journal 2018;16(7):5361.