Address https://gelex.eu/eli/EU/regulation/2022/684@2022-04-28/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
3. ANNEX

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 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001, 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 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 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.

(5) Commission Implementing Regulation (EU) 2021/900 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 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 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,

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, 28 April 2022. 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 galacto-oligosaccharide is replaced by the following: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements Data protection Galacto-oligosaccharide Specified food category Maximum levels (expressed as ratio kg galacto-oligosaccharide/kg final food) Food supplements as defined in Directive 2002/46/EC 0,333 Food supplements as defined in Directive 2002/46/EC, excluding infants and young children 0,450 (corresponding to 5,4 g galacto-oligosaccharide/serving; maximum 3 servings/day up to a maximum of 16,2 g/day) Milk 0,020 Milk drinks 0,030 Meal replacement for weight control (as drinks) 0,020 Dairy analogue drinks 0,020 Yoghurt 0,033 Dairy based desserts 0,043 Frozen dairy desserts 0,043 Fruit drinks and energy drinks 0,021 Infant meal replacement drinks 0,012 Baby juice 0,025 Baby yogurt drink 0,024 Baby dessert 0,027 Baby snack 0,143 Baby cereals 0,027 Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen 0,013 Juice 0,021 Fruit pie filling 0,059 Fruit preparations 0,125 Bars 0,125 Cereals 0,125 Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 0,008 Dairy confectionery 0,05 Cheese and processed cheese 0,1 Butter and spreadable fats 0,1

Versions

1. 2022-04-28

Cited by

• Commission Implementing Regulation (EU) 2026/1749 of 20 July 2026 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food galacto-oligosaccharide (Text with EEA relevance) Regulation · Grade B

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

• Commission Implementing Regulation (EU) 2022/1381 of 8 August 2022 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food galacto-oligosaccharide (Text with EEA relevance) Regulation · Grade B

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