1. EU Delegated Regulation (EU) 2025/2017 adds a new “protein-related requirements Group E” for infant and follow-on formula manufactured from specific protein hydrolysates, effective January 1, 2026. 2. Group E authorizes a cow’s milk whey protein hydrolysate (≥80% protein concentrate) with defined processing and amino acid requirements, and sets a protein range of 0.48–0.67 g/100 kJ. 3. The amendment expands permissible protein sources, enabling more flexible infant formula formulation and market access in the EU, based on EFSA’s positive safety assessment.
On December 12, 2025, the European Commission published Delegated Regulation (EU) 2025/2017 in the Official Journal of the European Union. The core change is the addition of "Protein-related requirements group E" to the compositional requirements for infant and follow-on formula manufactured from protein hydrolysates. The new regulation will enter into force on January 1, 2026.
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EU Proposes to Update Protein Requirements for Infant and Follow-on Formula Manufactured from Protein Hydrolysates
EU Amends Protein-related Requirements for Infant and Follow-on Formula Manufactured from Protein Hydrolysates
[Updated] China Appends Soybean Protein Isolate and Whey Protein into Health Food Raw Materials Directory
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A new regulatory framework is set to take effect on June 1, 2026, introducing updated requirements and procedures that will further impact overseas manufacturers.
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