On 23 June 2014, the company Glycom A/S made a request to the competent authorities of Ireland to place 2′-O-fucosyllactose on the market as a novel food ingredient.

On 3 October 2014, the competent food assessment body of Ireland issued its initial assessment report. In that report, it came to the conclusion that 2′-O-fucosyllactose meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

On 9 October 2014, the Commission forwarded the initial assessment report to the other Member States.

Reasoned objections were raised within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97.

On 22 December 2014, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an assessment for 2′-O-fucosyllactose as a novel food ingredient in accordance with Regulation (EC) No 258/97.

On 29 June 2015, EFSA in its ‘Scientific Opinion on the safety of 2′-O-fucosyllactose as a novel food ingredient pursuant to Regulation (EC) No 258/97’, concluded that 2′-O-fucosyllactose is safe for the proposed uses and use levels.

On 5 October 2015, the applicant sent a letter to the Commission and provided additional information to support the use and approval of 2′-O-fucosyllactose and lacto-N-neotetraose in food supplements for general population (excluding infants) under Regulation (EC) No 258/97.

On 14 October 2015, the Commission consulted EFSA asking it to carry out an assessment of the safety of these novel foods in food supplements also for children (excluding infants).

On 28 October 2015, EFSA in its ‘Statement on the safety of lacto-N-neotetraose and 2′-O-fucosyllactose as novel food ingredients in food supplements for children’, concluded that 2′-O-fucosyllactose is safe for the proposed uses and use levels.

Commission Directive 96/8/EC lays down requirements on foods intended for use in energy-restricted diets for weight reduction. Commission Directive 1999/21/EC lays down requirements for dietary foods for special medical purposes. Directive 2002/46/EC of the European Parliament and of the Council lays down requirements on food supplements. Commission Directive 2006/125/EC lays down requirements for processed cereal-based foods and baby foods for infants and young children. Commission Directive 2006/141/EC lays down requirements for infant formulae and follow-on formulae. Regulation (EC) No 1925/2006 of the European Parliament and of the Council lays down requirements on the addition of vitamins and minerals and of certain other substances to foods. Commission Regulation (EC) No 41/2009 lays down requirements for the composition and labelling of foodstuffs suitable for people intolerant to gluten. Commission Implementing Regulation (EU) No 828/2014 lays down the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food. The use of 2′-O-fucosyllactose should be authorised without prejudice to the requirements of those legislations

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