Protein hydrolysates in infant and follow-on formula
- Food safety
- Food supplements/dietetic foods
Summary
The European Union (EU) has changed the compositional requirements regarding the content, source, processing, and quality of protein for infant and follow-on formula manufactured from protein hydrolysates. Protein from cow’s milk consisting of 100% whey protein concentrate with a minimum protein content of 80% can now be used as protein hydrolysates in follow-on formula under certain conditions.
EU amends specifications for protein hydrolysates in infant and follow-on formula
Commission Delegated Regulation (EU) 2025/2017 of 8 October 2025 amending Delegated Regulation (EU) 2016/127 as regards the protein-related requirements for infant and follow-on formula manufactured from protein hydrolysates
Commission Delegated Regulation (EU) 2024/2684 of 2 February 2024 amending Delegated Regulation (EU) 2016/127 as regards the protein-related requirements for infant and follow-on formula manufactured from protein hydrolysates
Update
The European Union (EU) has changed the compositional requirements regarding the content, source, processing, and quality of protein for infant and follow-on formula manufactured from protein hydrolysates. Protein from cow’s milk consisting of 100% whey protein concentrate with a minimum protein content of 80% can now be used as protein hydrolysates in follow-on formula under certain conditions.
Impacted Products
Infant and follow-on formula
What is changing?
The EU has updated the compositional requirements set out in Regulation 2016/127 for the content, source, processing, and quality of protein for infant and follow-on formula manufactured from protein hydrolysates. It has introduced compositional requirements for protein from cow’s milk consisting of 100% whey protein concentrate with a minimum protein content of 80%. This protein hydrolysate can be used in follow-on formula if it complies with the compositional criteria set out in Regulation 2016/127, including the amino acid pattern (Section A, Annex III), and has a minimum protein content of 0.48 g/100 kJ (2.0 g/100 kcal).
In February 2024, Regulation 2024/2684 approved a specific protein hydrolysate (whey protein derived from cow’s milk, consisting of 100% sweet whey protein concentrate with a minimum protein content of 70%) with a different composition from those previously approved (under Regulation 2016/127).
Why?
Following a request by Fonterra Co-operative Group Ltd for an evaluation of two infant and follow-on formula products that did not comply with current rules, the European Food Safety Authority (EFSA 2025) concluded that this specific protein hydrolysate is nutritionally safe and is a suitable protein source for use in infant and follow-on formula if certain conditions are met.
Timeline
The Regulation applies from 1 January 2026.
Background
Infant formula and follow-on formula manufactured from protein hydrolysates must comply with certain requirements for the content, source, and processing of protein, as well as with requirements for indispensable and conditionally indispensable amino acids and L-carnitine (Regulation 2016/127). These requirements may be updated at the request of a formula manufacturer, following a safety and suitability evaluation by EFSA.
Resources
EFSA (2023) Nutritional safety and suitability of a specific protein hydrolysate derived from a whey protein concentrate and used in an infant formula and follow‐on formula manufactured from hydrolysed protein by FrieslandCampina Nederland B.V. EFSA Journal, 21(7): e08063
EFSA (2025) Nutritional safety and suitability of a specific protein hydrolysate manufactured by Fonterra Co-operative Group Ltd derived from a whey protein concentrate and used in infant formula and follow-on formula. EFSA Journal, 23(1): e9160
Regulation 2016/127 as regards the specific compositional and information requirements for infant formula and follow-on formula
Sources
Commission Delegated Regulation (EU) 2025/2017 as regards the protein-related requirements for infant and follow-on formula manufactured from protein hydrolysates
Commission Delegated Regulation (EU) 2024/2684 as regards the protein-related requirements for infant and follow-on formula manufactured from protein hydrolysates
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EU amends specifications for protein hydrolysates in infant and follow-on formula
Commission Delegated Regulation (EU) 2025/2017 as regards the protein-related requirements for infant and follow-on formula manufactured from protein hydrolysates
Commission Delegated Regulation (EU) 2024/2684 as regards the protein-related requirements for infant and follow-on formula manufactured from protein hydrolysates
What is changing and why?
The European Union (EU) has updated the compositional requirements for the content, source, processing, and quality of protein for infant and follow-on formula manufactured from protein hydrolysates. This follows an evaluation by the European Food Safety Authority of a specific protein hydrolysate: protein from cow’s milk consisting of 100% whey protein concentrate with a minimum protein content of 80%. The conditions of use are set out in the Annex to Regulation 2016/127.
In 2024, the European Commission approved a specific protein hydrolysate derived from whey protein for use in infant formula and follow-on formula.
Timeline
The Regulation applies from 1 January 2026.
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.