(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 2’-Fucosyllactose of synthetic and microbial source as an authorised novel food.

(4)

Commission Implementing Decision (EU) 2016/376 (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 synthetic 2’-Fucosyllactose as a novel food ingredient.

(5)

On 23 June 2016, the company Glycom A/S (‘the applicant’), notified the Commission, pursuant to Article 5 of Regulation (EC) No 258/97, of its intention to place on the market 2’-Fucosyllactose produced by bacterial fermentation with Escherichia coli strain K-12. 2’-Fucosyllactose of microbial origin produced with 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 Decision (EU) 2017/2201 (5) authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of 2’-Fucosyllactose produced with Escherichia coli strain BL21 as a novel food ingredient.

(7)

On 13 October 2022, 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 2’-Fucosyllactose. The applicant requested the removal of the obligatory condition that, when 2’-Fucosyllactose is used in combination with Lacto-N-neotetraose in infant formula and follow-on formula as defined in Article 2 of Regulation (EU) No 609/2013 of the European Parliament and of the Council (6), and in milk-based drinks and similar products intended for young children, at the currently authorised levels of up to 1,2 g/l, they should be used only at a 2:1 ratio (two parts 2’-Fucosyllactose to one part Lacto-N-neotetraose).

(8)

In the application for the proposed modification in the conditions of use of 2’-Fucosyllactose, the applicant considered that the 2:1 obligatory ratio of 2’-Fucosyllactose to Lacto-N-neotetraose when they are used together in infant formula and follow on formula as defined in Article 2 of Regulation (EU) No 609/2013, and 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

(9)

The Commission considers that the requested update of the Union list of novel foods 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 the recent opinion (7), concluded that the use of 2’-Fucosyllactose alone or Lacto-N-neotetraose alone in food supplements as defined in Article 2 of Directive 2002/46/EC of the European Parliament and of the Council (8) at the currently maximum authorised levels of up to 1,2 g/day or up to 0,6 mg/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.

(10)

The information provided in the application and the Authority’s opinion give sufficient grounds to establish that the changes in the conditions of use of the novel food 2’-Fucosyllactose are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.

(11)

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

(12)

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