(Utkast) Kommisjonsforordning (EU) .../... om endring av vedlegg II til europaparlaments- og rådsforordning (EF) nr. 1925/2006 og vedlegg II til europaparlaments- og rådsdirektiv 2002/46/EF med hensyn til kaseinater fra melk tilsatt næringsmidler og kosttilskudd
Berikingsforordningen og kosttilskuddsdirektivet: kaseinater fra melk
(Draft) Commission Regulation (EU) .../... amending Annex II to Regulation (EC) No 1925/2006 of the European Parliament and of the Council and Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards iron milk caseinate added to foods and used in the manufacture of food supplements
Utkast til kommisjonsforordning sendt til Europaparlamentet og Rådet for klarering og publisert i EUs komitologiregister 7.3.2024
Nærmere omtale
BAKGRUNN (fra kommisjonsforordningen)
(1) Annexes I and II to Regulation (EC) No 1925/2006 establish the list of vitamin and mineral substances which may be added to foods and the forms in which they may be added.
(2) Annexes I and II to Directive 2002/46/EC establish the list of vitamin and mineral substances which may be used in the manufacture of food supplements and the forms in which they may be added.
(3) Commission Implementing Regulation (EU) 2023/949 authorised iron milk caseinate as a novel food in, among other products, certain foods and food supplements subject to specific conditions.
(4) 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.
(5) Iron milk caseinate was on the basis of that scientific opinion included in the Union list of authorised novel foods provided for in the Annex to Commission Implementing Regulation (EU) 2017/2470.
(6) The Commission considers that the Authority’s opinion gives sufficient grounds to establish that the use of iron milk caseinate as authorized by Commission Implementing Regulation (EU) 2023/949, when used in foods and food supplements as specified therein, and excluding the use for infants and young children is not of safety concern as a source of iron.
(7) Based on the Authority’s favourable opinion and on the authorisation as a novel food as set out in Commission Implementing Regulation (EU) 2023/949, iron milk caseinate should be included in Annex II Directive 2002/46/EC and in Annex II to Regulation (EC) No 1925/2006 as a form of iron.
(8) The Advisory Group on the Food Chain and Animal and Plant Health was consulted and its comments were taken into consideration.
(9) Annex II to Directive 2002/46/EC and Annex II to Regulation (EC) No 1925/2006 should therefore be amended accordingly.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,