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On October 11, 2024, the European Union (EU) published Commission Delegated Regulation (EU) 2024/2684, amending Delegated Regulation (EU) 2016/127 concerning the protein-related requirements for infant and follow-on formula manufactured from protein hydrolysates. This amendment comes effect immediately upon publication.
Delegated Regulation (EU) 2016/127 has outlines specific compositional requirements for infant and follow-on formula manufactured from protein hydrolysates. In Annex I, point 2.3 and Annex II, point 2.3, Delegated Regulation (EU) 2016/127 stipulates that infant formula and follow-on formula “manufactured from protein hydrolysates shall comply with the protein-related requirements provided under point 2.3.1, point 2.3.2, or point 2.3.3”.
The amendment issued on Oct 11, 2024 introduces a new point, 2.3.4, titled "Protein-related requirements group D" to both Annexes I and II for infant and follow-up formula, respectively. This new point stipulates the requirements for infant and follow-on formula manufactured from protein hydrolysates regarding protein content, protein source, protein processing and indispensable and conditionally indispensable amino acids and L-carnitine. For instance, the minimum protein content is set at 0.57 g/100 kJ, while the maximum is 0.67 g/100 kJ. This revision is primarily an update based on a scientific opinion issued by the European Food Safety Authority (EFSA) in July 2023.
Additionally, the introductory sentence in section A of Annex III has been revised.
Read more about the full text here.
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