BAKGRUNN (fra kommisjonsforordningen)

(1) Annexes I and II to Directive 2002/46/EC establish the list of vitamin and mineral substances, and for each of them the forms, which may be used in the manufacture of food supplements.

(2) Pursuant to Article 14 of Directive 2002/46/EC, provisions on vitamin and mineral substances in food supplements that 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 from the European Commission to deliver an opinion on iron hydroxide adipate tartrate as a novel food pursuant to Regulation (EU) 2015/2283 of the European Parliament and of the Council and as a source of iron in the context of Directive 2002/46/EC, on 27 October 2021 the Authority adopted a scientific opinion on the matter . 

(4) It follows from that opinion that iron hydroxide adipate tartrate used in food supplements is not of safety concern provided that certain conditions are respected which are set out in Commission Implementing Regulation (EU) 2022/1373. Based on the Authority’s favourable opinion and on the authorisation as novel food ingredient as set out in Implementing Regulation (EU) 2022/1373, iron hydroxide adipate tartrate should be included in the list set out in Annex II to Directive 2002/46/EC in order to allow its use as a source of iron in food supplements.

(5) Directive 2002/46/EC should therefore be amended accordingly.

(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,