(Utkast) Delegert kommisjonsforordning (EU) .../... av 2. februar 2024 om endring av delegert forordning (EU) 2016/127 med hensyn til proteinrelaterte krav til morsmelkerstatninger og tilskuddsblandinger framstilt av proteinhydrolysater
Morsmelkerstatning og tilskuddsblandinger til spedbarn og småbarn: endringsbestemmelser om produkter fremstilt av hydrolysert protein
Utkast til delegert kommisjonsforordning sendt til Europaparlamentet og Rådet for klarering 2.2.2024
Nærmere omtale
BAKGRUNN (fra kommisjonsforordningen)
(1) Commission Delegated Regulation (EU) 2016/127 lays down specific compositional requirements for infant formula and follow-on formula manufactured from protein hydrolysates. It provides that infant formula and follow-on formula manufactured from protein hydrolysates are to comply with the requirements for protein content, protein source, protein processing as well as with the requirements for indispensable and conditionally indispensable amino acids and L-carnitine as set out in point 2.3 of Annex I and in point 2.3 of Annex II to that Regulation.
(2) As stated in Delegated Regulation (EU) 2016/127, in its opinion of 24 July 2014 on the essential composition of infant and follow-on formulae, the European Food Safety Authority (‘the Authority’) noted that the safety and suitability of each specific formula containing protein hydrolysates has to be established by clinical evaluation in the target population. So far, the Authority has positively evaluated three protein hydrolysates used in infant and follow-on formulae. The composition of those three protein hydrolysates is reflected in the requirements currently set out in Delegated Regulation (EU) 2016/127. However, those requirements may be updated in order to allow the placing on the market of a formula manufactured from protein hydrolysates with a different composition from those already positively assessed, following a caseby-case evaluation by the Authority of their safety and suitability.
(3) On 6 December 2019, the Commission received a request from FrieslandCampina Nederland B.V. for the evaluation by the Authority of the safety and suitability of two products, an infant and follow-on formula manufactured from a specific protein hydrolysate, the composition of which did not comply with the requirements laid down in point 2.3 of Annex I and in point 2.3 of Annex II to Delegated Regulation (EU) 2016/127.
(4) Upon request from the Commission, the Authority issued a scientific opinion on 18 July 2023 on the nutritional safety and suitability of that infant and follow-on formula. In that opinion, the Authority concluded that the protein hydrolysate in question is a nutritionally safe and suitable protein source for use in infant and followon formula, as long as the formula in which it is used contains a minimum of 0.57 g/100 kJ (2.4 g/100 kcal) protein and complies with the other compositional criteria set out in Delegated Regulation (EU) 2016/127 and with the amino acid pattern contained in Section A of Annex III to that Regulation.
(5) Taking into account the Authority’s conclusions, it is appropriate to allow the placing on the market of infant and follow-on formula manufactured from the specific protein hydrolysate as described in the opinion. Therefore, the requirements for protein hydrolysates set out in Regulation (EU) 2016/127 should be updated and adapted to also include the requirements for the specific protein hydrolysate as described in the opinion.
(6) Annexes I, II and III to Delegated Regulation (EU) 2016/127 should therefore be amended accordingly.
(7) Delegated Regulation (EU) 2016/127 applies to infant and follow-on formula manufactured from protein hydrolysates as of 22 February 2022. In order to allow the placing on the market of infant and follow‐on formula manufactured from hydrolysed protein in accordance with the requirements set out in this Regulation without unnecessary delay, this Regulation should enter into force as a matter of urgency,