BAKGRUNN (fra kommisjonsforordningen)

(1) The Annex to Regulation (EU) No 609/2013 establishes a Union list of substances that may be added to one or more of the categories of food referred to in Article 1(1) of that Regulation. 

(2) Commission Implementing Regulation (EU) 2023/949 authorised the use of iron milk caseinate as a novel food in, among other products, food for special medical purposes, excluding food for infants and young children and total diet replacement for weight control, subject to certain conditions. 

(3) During the process of authorisation, on 4 August 2022, the European Food Safety Authority (‘the Authority’) issued a scientific opinion where it concluded that iron milk caseinate is safe under the proposed conditions of use and that it is a source from which iron is bioavailable. 

(4) The Commission considers that the Authority’s opinion gives sufficient grounds to establish that iron milk caseinate, as authorized by Regulation (EU) 2023/949, is not of safety concern as a source of iron when used in food for special medical purposes, excluding food for infants and young children and in total diet replacement for weight control, Therefore, it is appropriate to allow the use of iron milk caseinate as a source of iron in food for special medical purposes, excluding food for infants and young children and in total diet replacement for weight control. 

(5) That substance should therefore be included in the Union list of substances that may be added to certain categories of food. 

(6) The Annex to Regulation (EU) No 609/2013 should therefore be amended accordingly,