BAKGRUNN (fra kommisjonsforordningen)

(1)    Annexes I and II to Directive 2002/46/EC establish the lists of vitamins and minerals, 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 vitamins and minerals 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 Commission to deliver an opinion on calcidiol monohydrate as a novel food pursuant to Regulation (EU) 2015/2283 of the European Parliament and of the Council  and as a source of vitamin D in the context of Directive 2002/46/EC, on 25 May 2021, the Authority has adopted a scientific opinion on the matter . 
 

(4)    It follows from that opinion that there are no safety concerns about the use of calcidiol monohydrate in food supplements, provided that the conditions for its authorisation set out in Commission Implementing Regulation (EU) 2024/1052  are met. Based on the Authority’s favourable opinion and on its authorisation as a novel food ingredient in Implementing Regulation (EU) 2024/1052, calcidiol monohydrate should be included in the list of vitamin and mineral substances set out in Annex II to Directive 2002/46/EC, in order to allow its use as a source of vitamin D 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 Plants, Animals, Food and Feed,