Commission Delegated Regulation (EU) 2022/519 of 14 January 2022 amending Delegated Regulation (EU) 2016/127 as regards the protein requirements for infant and follow-on formula manufactured from protein hydrolysates (Text with EEA relevance)
Commission Delegated Regulation (EU) 2022/519of 14 January 2022amending Delegated Regulation (EU) 2016/127 as regards the protein requirements for infant and follow-on formula manufactured from protein hydrolysates(Text with EEA relevance)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009OJ L 181, 29.6.2013, p. 35., and in particular Article 11(2) thereof,Whereas:(1)Commission Delegated Regulation (EU) 2016/127Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding (OJ L 25, 2.2.2016, p. 1). lays down, amongst others, specific compositional requirements for infant formula and follow-on formula manufactured from protein hydrolysates. It provides that infant 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 point 2.3 of Annex II to that Regulation.(2)As stated in the recitals of Delegated Regulation (EU) 2016/127, in its opinion of 24 July 2014 on the essential composition of infant and follow-on formulaeEFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the essential composition of infant and follow-on formulae. EFSA Journal 2014;12(7):3760., 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. The Authority further stated that only one formula containing partially hydrolysed whey protein had been positively evaluated by the Authority so far. The composition of the formula evaluated by the Authority corresponds to 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 formula manufactured from protein hydrolysates with a composition different from the one already positively assessed, following a case-by-case evaluation of their safety and suitability by the Authority.(3)On 20 September 2019, the Commission received a request from Danone Trading ELN B.V. for the evaluation by the Authority of the safety and suitability of an infant and follow-on formula manufactured from a protein hydrolysate, the composition of which does not comply with the requirements laid down in point 2.3 of Annex I and 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 28 November 2020 on the nutritional safety and suitability of the specific protein hydrolysate derived from whey protein concentrate and used in an infant and follow-on formula manufactured from hydrolysed protein by Danone Trading ELN B.VEFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), 2020. Nutritional safety and suitability of a specific protein hydrolysate derived from whey protein concentrate and used in an infant and follow-on formula manufactured from hydrolysed protein by Danone Trading ELN B.V. EFSA Journal 2020;18(11):6304.. The Authority concluded that the protein hydrolysate in question is a nutritionally safe and suitable protein source for use in infant and follow-on formula, as long as the formula in which it is used contains a minimum of 0,55 g/100 kJ (2,3 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 conclusions of the Authority’s opinion of 2020, it is appropriate to allow the placing on the market of infant and follow-on formula manufactured from the protein hydrolysate in question. Therefore, the requirements for protein hydrolysates set out in Regulation (EU) 2016/127 should be updated and adapted to include also the requirements concerning this protein hydrolysate.(6)Delegated Regulation (EU) 2016/127 provides that its provisions on infant and follow-on formula manufactured from protein hydrolysates are to apply from 22 February 2022. In order to allow infant and follow-on formula manufactured from hydrolysed protein in accordance with the requirements set out in this Regulation to remain in the market from that date, this Regulation should enter into force as a matter of urgency.(7)Annexes I, II and III to Delegated Regulation (EU) 2016/127 should therefore be amended accordingly,HAS ADOPTED THIS REGULATION: