(fra kommisjonsforordningen)

(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 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, galacto-oligosaccharide was 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. 

(5) Commission Implementing Regulation (EU) 2021/900 amended the conditions of use of the novel food galacto-oligosaccharide. In particular, the maximum 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 was increased from 0,333 kg galacto-oligosaccharide/kg food supplement (33,3 %) to 0,450 kg galactooligosaccharide/kg food supplement (45,0 %), for the general population, excluding infants and young children. 

(6) Commission Implementing Regulation (EU) 2022/684 amended the conditions of use of the novel food galacto-oligosaccharide. In particular, the use of galactooligosaccharide was extended to additional foods, namely, dairy confectionary, cheese and processed cheese, butter and spreadable fats. 

(7) Commission Implementing Regulation (EU) 2022/1381 amended the conditions of use of the novel food galacto-oligosaccharide. In particular, the use of galactooligosaccharide was extended to foods for special medical purposes as defined by Regulation (EU) No 609/2013, intended for the general population, excluding infants and young children. 

(8) Council Directive 2001/112/EC defines fruit juices and certain similar products intended for human consumption. Council Directive 2001/113/EC defines fruit jams, jellies and marmalades and sweetened chestnut purée intended for human consumption. Those Directives lay down specific provisions regarding the designation and compositional requirements of the products within their scope. Only certain designations for fruit juices and similar products, fruit jams, jellies and marmalades and sweetened chestnut purée and only certain ingredients and substances authorised by those Directives may be used for those food categories. While the Union list of novel foods applies without prejudice to other provisions laid down in sector specific legislation, certain food categories for which the conditions of use of galactooligosaccharide are authorised, do not entirely correspond to the similar products defined in Directives 2001/112/EC and 2001/113/EC. To ensure regulatory consistency and clarity, it is appropriate that the conditions of use of galactooligosaccharide and the designation of the food categories in which it is to be used should be amended to allow a distinction between them and the categories referred to in Directives 2001/112/EC and 2001/113/EC. 

(9) The conditions of use of ‘galacto-oligosaccharide’ for the food category ‘fruit drinks except products defined in Part I of Annex I to Directive 2001/112/EC and energy drinks’, are currently authorised at the same maximum levels of 0.021 kg galactooligosaccharide/kg final food. Since this category encompasses two types of products that are not functionally equivalent for the purposes of this authorisation, it is appropriate in the interest of clarity, to distinguish between them. Therefore, the category should be divided into two categories: ‘fruit drinks except products defined in Part I of Annex I to Directive 2001/112/EC’ on the one hand, and ‘energy drinks’ on the other hand. 

(10) Pursuant to Regulation (EU) No 1308/2013 of the European Parliament and of the Council, the term ‘milk’ and designations reserved for milk products may only be used for products complying with the definitions laid down in that Regulation. In order to ensure consistency with those definitions and to avoid any potential misinterpretation as to the nature and composition of the products concerned, it is appropriate to replace the term ‘milk drinks’ with ‘milk-based drinks’ in the Annex to Implementing Regulation (EU) 2017/2470. 

(11) Among the conditions of use of ‘galacto-oligosaccharide’, the food categories dairybased desserts’ and ‘frozen dairy desserts’, are authorised as separate categories at the same maximum levels of 0.043 kg galacto-oligosaccharide/kg final food. Considering that those categories are technologically and functionally equivalent for the purposes of this authorisation, it is appropriate in the interest of simplification and clarity, to merge them into the single category of ‘dairy-based desserts’. 

(12) Among the conditions of use of ‘galacto-oligosaccharide’, the food categories ‘bars’ and ‘cereals’ are authorised as separate categories at the same maximum levels of 0.125 kg galacto-oligosaccharide/kg final food. In order to ensure clarity and given that these categories cover similar products for the purposes of the authorisation, it is appropriate to merge those categories into the following single category: ‘processed and breakfast cereals, including cereal bars’. 

(13) Among the conditions of use of ‘galacto-oligosaccharide’, the food categories ‘baby juice’, ‘baby yogurt drink’, ‘baby dessert’, ‘baby snack’, ‘baby cereals’, and infant meal replacement drinks are authorised as separate categories. Given that those categories fall within the broader regulatory framework of processed cereal-based foods and baby foods for infants and young children, as defined in Regulation (EU) No 609/2013, it is appropriate, in the interest of regulatory consistency and clarity to reflect that in the Union list of authorised novel foods. 

(14) On 21 March 2025, the company FrieslandCampina Ingredients (‘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 the novel food galacto-oligosaccharide. The applicant requested to extend the use of galactooligosaccharide to syrups, and powdered drink bases for the preparation of flavoured drinks, chocolate confectionery, chocolate-coated confectionery, other confectionery products, including chewing gum but excluding dairy, chocolate and chocolate-coated confectionery, beverages such as cola type drinks and flavoured drinks, fruit or vegetable juice concentrate except products defined in Part I of Annex I to Directive 2001/112/EC, whey based powder, protein products, excluding dairy analogues; iced coffee-based drinks, flavoured milk-based drinks, powder cocoa beverage preparations, cocoa-based beverages and liquid drink bases, including concentrates and home-made preparations, intended for the general population. 

(15) In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 18 July 2025, requesting it to provide a scientific opinion on the proposed extension of use of the novel food galacto-oligosaccharide. 

(16) On 19 November 2025, 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’ in accordance with Article 11 of Regulation (EU) 2015/2283. 

(17) In its scientific opinion, the Authority concluded that the novel food is safe under the proposed conditions of use, and therefore it is appropriate to amend the conditions of use of galacto-oligosaccharide. 

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

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

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