Contents
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplementsnote, and in particular Article 4(5) thereof,Whereas:
(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 Councilnote 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 matternote.
(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) 2022/1373note. 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,
HAS ADOPTED THIS REGULATION:
Article 1#
Annex II to Directive 2002/46/EC 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.
In point B of Annex II to Directive 2002/46/EC, the following entry is inserted after the entry for ‘ferric sodium EDTA’:
‘iron hydroxide adipate tartrate (nano)note
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