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-N-neotetraose (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 and Commission Regulation (EC) No 1852/2001 ¹, and in particular Article 12 thereof,

Whereas:

• (1) Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.

• (2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 ² has established a Union list of novel foods.

• (3) The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes Lacto-N-neotetraose of synthetic and microbial source as authorised novel food.

• (4) Commission Implementing Decision (EU) 2016/375 ³ authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council ⁴, the placing on the market of chemically synthesised Lacto-N-neotetraose as a novel food ingredient.

• (5) Pursuant to Article 5 of Regulation (EC) No 258/97, on 1 September 2016, the company Glycom A/S, notified the Commission of its intention to place on the market Lacto-N-neotetraose of microbial source produced with genetically modified Escherichia coli strain K-12 as a novel food ingredient. Lacto-N-neotetraose of microbial origin produced with genetically modified Escherichia coli strain K-12 was included in the Union list of novel foods on the basis of that notification when the Union list was established.

• (6) Commission Implementing Regulation (EU) 2019/1314 ⁵ amended the specifications of the novel food Lacto-N-neotetraose (microbial source) produced with genetically modified Escherichia coli strain K-12.

• (7) Commission Implementing Regulation (EU) 2021/912 ⁶ amended the specifications of the novel food Lacto-N-neotetraose (microbial source) to allow the novel food Lacto-N-neotetraose produced by the combined activity of the genetically modified strains PS-LNnT-JBT and DS-LNnT-JBT derived from Escherichia coli strain BL21(DE3) to be placed on the market and be used in the previously authorised uses and at the previously authorised use levels.

• (8) On 3 October 2022, the company Glycom A/S (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change in the conditions of use of Lacto-N-neotetraose. The application requested for Lacto-N-neotetraose to be used in infant formula, follow-on formula as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council ⁷, at the currently authorised levels of up to 0,6 g/l, without the obligatory use in combination with 2′-Fucosyllactose at a 1:2 use ratio (one part Lacto-N-neotetraose with two parts 2′-Fucosyllactose), and in milk-based drinks and similar products intended for young children without the obligatory use in combination with 2′-Fucosyllactose at a 1:2 use ratio when the two novel foods are added separately.

• (9) In the application for the proposed modification in the conditions of use of Lacto-N-neotetraose, the applicant considered that obligatory use of a combination of Lacto-N-neotetraose with 2′-Fucosyllactose at a 1:2 ratio when they are used together in infant formula and follow-on formula as defined in Article 2 of Regulation (EU) No 609/2013, or at different ratios with 2′-Fucosyllactose when the two are used in combination in milk-based drinks and similar products intended for young children, unnecessarily limits the ability of food business operators to place on the market these foods with different ratios of those two oligosaccharides.

• (10) The Commission considers that the requested update of the Union list concerning the change in the conditions of use of Lacto-N-neotetraose proposed by the applicant is not liable to have an effect on human health and that a safety evaluation by the European Food Safety Authority (‘the Authority’) in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. In this regard, the Authority in a recent opinion ⁸ concluded that the use of Lacto-N-neotetraose alone or 2′-Fucosyllactose alone in food supplements as defined in Article 2 of Directive 2002/46/EC of the European Parliament and of the Council ⁹ at the currently maximum authorised levels of up to 0,6 mg/day or up to 1,2 g/day respectively, is safe and the resulting intakes of each of these oligosaccharides from these uses would be lower than the intakes of Lacto-N-neotetraose or 2′-Fucosyllactose from human milk which naturally contains them.

• (11) The information provided in the application and existing Authority’s opinions gives sufficient grounds to establish that the changes in the conditions of use of the novel food Lacto-N-neotetraose should be approved.

• (12) The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

• (13) 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 amended in accordance with the Annex to this Regulation.

Article 2

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

).

ANNEX

In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for lacto-N-neotetraose is replaced by the following: