(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 galacto-oligosaccharide as an authorised novel food.

(4)

Pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3), galacto-oligosaccharide has been authorised to be placed on the market as a novel food to be used in a number of foods, including infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (4).

(5)

Commission Implementing Regulation (EU) 2021/900 (5) authorised a change of the conditions of use of the novel food galacto-oligosaccharide. In particular, the use level of the novel food galacto-oligosaccharide in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (6) was increased from 0,333 kg galacto-oligosaccharide/kg of a food supplement (33,3 %) to 0,450 kg galacto-oligosaccharide/kg of a food supplement (45,0 %) for the general population, excluding infants and young children.

(6)

On 19 November 2019, the company Dairy Crest Ltd trading as Saputo Dairy UK (‘the applicant’) submitted an application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 for an amendment of the conditions of use of the novel food galacto-oligosaccharide. The applicant requested to extend the use of galacto-oligosaccharide to dairy confectionary, cheese and processed cheese, butter and spreads intended for the general population.

(7)

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 21 December 2020, requesting it to provide a scientific opinion by carrying out an assessment of the proposed extension of use of the novel food galacto-oligosaccharide.

(8)

On 14 September 2021, the Authority adopted its scientific opinion on the ‘Safety of the extension of use of galacto-oligosaccharides as a Novel food pursuant to Regulation (EU) 2015/2283’ (7) in accordance with Article 11 of Regulation (EU) 2015/2283.

(9)

In its scientific opinion, the Authority concluded that the novel food that is composed of ≥ 57 % galacto-oligosaccharide dry matter, lactose and related saccharides, is safe under the proposed extension of use in dairy confectionary, cheese and processed cheese, butter and spreads, and therefore it is appropriate to amend the conditions of use of galacto-oligosaccharide.

(10)

The information provided in the application and the Authority’s opinion gives sufficient grounds to establish that the proposed changes to the conditions of use of the novel food are in accordance with Article 9 and Article 12(1) 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,