(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)

Commission Implementing Regulation (EU) 2021/96 (3) authorised the placing on the Union market of 3′-Sialyllactose sodium salt obtained by microbial fermentation using the genetically modified strain K-12 DH1 of Escherichia coli (‘E. coli’) as a novel food under Regulation (EU) 2015/2283.

(4)

Commission Implementing Regulation (EU) 2023/113 (4) authorised the placing on the Union market of 3′-Sialyllactose sodium salt obtained by microbial fermentation using genetically modified derivative strains of E. coli BL21(DE3) as a novel food under Regulation (EU) 2015/2283.

(5)

On 8 February 2023, the company Chr. Hansen A/S (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change of the conditions of use of 3′-Sialyllactose (‘3′-SL’) sodium salt, obtained by microbial fermentation using genetically modified derivative strains (a production strain and an optional degradation strain) of E. coli BL21(DE3). The applicant requested for an increase of the maximum levels of 3′-SL sodium salt used in infant formula as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (5), from the currently maximum authorised level of 0,23 g/kg or l to a maximum level of 0,28 g/kg or l, and to extend the use of 3′-SL sodium salt in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (6) intended for infants and young children at the levels of 0,28 g/day. Subsequently, on 23 March 2023, the applicant modified the initial request in the application and removed from the proposed uses the use of 3′-SL sodium salt in food supplements intended for infants and young children.

(6)

The applicant justified the request for the proposed changes in the conditions of use of 3′-SL sodium salt in infant formula as defined in Regulation (EU) No 609/2013, as a means to bring the use levels of 3′-SL sodium salt in infant formula and the resulting intakes closer to the levels of 3′-SL naturally found in human milk.

(7)

The Commission considers that the requested update of the Union list concerning the change of the conditions of use of 3′-SL sodium salt produced by derivative strains of E. coli BL21(DE3) as 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 slightly increased intake of 3′-SL sodium salt that would result from this increased use in infant formula as defined in Regulation (EU) No 609/2013, would still be lower than the intakes of 3′-SL from breast milk that were considered by the Authority to be of no safety concern in its 2022 opinion of 3′-SL sodium salt produced by derivative strains of E. coli BL21(DE3). (7) The Commission also considers that the increase in the maximum use levels of 3′-SL sodium salt in infant formula from 0,23 g/kg or l to 0,28 g/kg or l should also be reflected in the conditions of use of foods for special medical purposes for infants and young children as defined under Regulation (EU) No 609/2013, as the maximum levels of 3′-SL sodium salt in those foods are linked to the maximum levels used in infant formula.

(8)

The information provided in the application and the Authority’s opinion of 2022 give sufficient grounds to establish that the changes to the conditions of use of 3′-SL sodium salt produced by derivative strains of E. coli strain BL21(DE3) are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.

(9)

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

(10)

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