(1)

Annex II to Directive 2002/46/EC establishes the list of vitamin and mineral substances, and for each of them the forms, which may be used in the manufacture of food supplements. Commission Regulation (EC) No 1170/2009 (2) has replaced Annexes I and II to Directive 2002/46/EC.

(2)

According to Article 14 of Directive 2002/46/EC, provisions on vitamin and mineral substances in food supplements which may have an effect upon public health are to be adopted after consultation with the European Food Safety Authority (‘the Authority’).

(3)

Following a request for the addition of (6S)-5-methyltetrahydrofolic acid, glucosamine salt as a source of folate to the list set out in Annex II to Directive 2002/46/EC, the Authority adopted on 11 September 2013 a Scientific Opinion on (6S)-5-methyltetrahydrofolic acid, glucosamine salt as a source of folate added for nutritional purposes to food supplements and the bioavailability of folate from this source (3).

(4)

It follows from the Authority's opinion that the use of (6S)-5-methyltetrahydrofolic acid, glucosamine salt in food supplements is not of safety concern as a source of folate.

(5)

Following the Authority's favourable opinion, (6S)-5-methyltetrahydrofolic acid, glucosamine salt should be added to the list set out in Annex II to Directive 2002/46/EC.

(6)

(6S)-5-methyltetrahydrofolic acid, glucosamine salt is a novel food ingredient the placing on the market of which has been authorised by Commission Implementing Decision 2014/154/EU (4).

(7)

Interested parties were consulted through the Advisory Group on the Food Chain and Animal and Plant Health and the comments provided were taken into consideration.

(8)

Directive 2002/46/EC should therefore be amended accordingly.

(9)

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