Introductory text

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients^f1, and in particular Article 7 thereof,

Whereas:

On 22 September 2015, the company Glycom A/S made a request to the competent authority of Ireland to place synthetic N-acetyl-D-neuraminic acid (N-acetyl-D-neuraminic acid (NANA)) on the Union market as a novel food ingredient within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97.

On 8 March 2016, the competent authority of Ireland issued its initial assessment report. In that report it came to the conclusion that N-acetyl-D-neuraminic acid meets the criteria for novel food ingredient set out in Article 3(1) of Regulation (EC) No 258/97.

On 15 March 2016, the Commission forwarded the initial assessment report to the other Member States.

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

On 14 July 2016, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for N-acetyl-D-neuraminic acid as a novel food ingredient in accordance with Regulation (EC) No 258/97.

On 28 June 2017, EFSA in its ‘Scientific Opinion on the safety of N-acetyl-D-neuraminic acid as a novel food pursuant to Regulation (EC) No 258/97’^f2 concluded that N-acetyl-D-neuraminic acid is safe when added to foods other than food supplements at the proposed uses and use levels for the general population. For food supplements EFSA established that N-acetyl-D-neuraminic acid is safe at the proposed uses and use levels for individuals above 10 years of age and is also safe for infants below 10 years of age, provided that the combined exposure from different sources does not exceed 11 mg/kg bw.

Therefore, the EFSA opinion gives sufficient grounds to establish that N-acetyl-D-neuraminic acid in the proposed uses and use levels for the general population complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97. Furthermore, the opinion also gives sufficient grounds to establish that N-acetyl-D-neuraminic acid in the proposed uses and use levels, when used as an ingredient in food supplements, complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97 provided that adequate labelling ensures that the threshold of 11 mg/kg bw is not exceeded by combined exposure from different sources for infants below 10 years of age.

Labelling requirements ensuring that consumers of food supplements are informed about a number of particulars are applicable to products containing N-acetyl-D-neuraminic acid already by virtue of Directive 2002/46/EC of the European Parliament and of the Council^f3, Regulation (EU) No 609/2013 of the European Parliament and of the Council^f4 and Regulation (EU) No 1169/2011 of the European Parliament and of the Council^f5. In addition, specific provisions on labelling are required to ensure the safety of food supplements containing N-acetyl-D-neuraminic acid when consumed by infants, young children and children under 10 years of age in combination with breast milk or other foods with added N-acetyl-D-neuraminic acid.

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

HAS ADOPTED THIS DECISION: