The operational question is narrow: what does Group F add to Reg. 2016/127, and which compositional and processing conditions must an operator meet before placing infant or follow-on formula made from that hydrolysate on the EU market? The answer sits in the Annex to 2026/743 (point 2.3.6 of Annexes I and II, plus the Section A cross-reference in Annex III) — not in the EFSA opinion alone, and not under a generic “milk hydrolysate” label.
1. What the act actually does
Commission Delegated Regulation (EU) 2026/743 of 30 March 2026 (OJ L series 2026/743, 9.6.2026; ELI: http://data.europa.eu/eli/reg_del/2026/743/oj; CELEX 32026R0743) amends Annexes I, II and III to Delegated Regulation (EU) 2016/127 for protein hydrolysates in infant formula (IF) and follow-on formula (FOF).
Article 2: the Regulation enters into force on the twentieth day following its publication in the Official Journal. With publication on 9 June 2026, that is 29 June 2026. It is binding in its entirety and directly applicable in all Member States. Text with EEA relevance.
2. EFSA e9278 ≠ Commission market access
The recitals record that on 15 February 2019 the Commission received a request from Healthcare Reckitt B.V. to have EFSA evaluate the safety and suitability of IF and FOF manufactured from a hydrolysate whose composition did not meet the then point 2.3 of Annexes I/II. The EFSA NDA Panel adopted its opinion on 29 January 2025 (EFSA Journal 2025;23:e9278; Q-2019-00305; DOI 10.2903/j.efsa.2025.9278).
The Panel concluded that the hydrolysate is a nutritionally safe and suitable protein source for IF/FOF provided the formula contains at least 0.55 g/100 kJ (2.3 g/100 kcal) protein and complies with the remaining criteria of Reg. 2016/127 and the amino-acid pattern in Section A of Annex III. In the intervention study, an IF with the hydrolysate at 2.3 g/100 kcal as the sole source of nutrition for 3 months supported growth similar to an intact cow’s-milk-protein IF at 1.9 g/100 kcal. No separate FOF trial was submitted — the Panel extrapolated suitability because FOF is consumed with complementary foods and the source is suitable in an IF that can be the sole nutrition of young infants.
Practically: EFSA assesses nutritional safety and suitability; the Commission amends the compositional list. Without the Group F entry in 2016/127, a positive opinion alone does not open the market.
3. Group F — conditions the operator must meet
After the amendment, IF (Annex I) and FOF (Annex II) manufactured from protein hydrolysates must comply with one of groups A–F. Group F (point 2.3.6) requires, together:
| Element (point) | Group F requirement |
|---|---|
| 2.3.6.1 Protein content | 0.55–0.67 g/100 kJ (2.3–2.8 g/100 kcal) |
| 2.3.6.2 Protein source | Mixtures of sources of skimmed cow’s milk and whey protein concentrates with an initial whey:casein (w/w) ratio of 60:40 |
| 2.3.6.3 Protein processing | Source material hydrated and heated; hydrolysis at pH 6.9–7.6 and 50–55.5 °C with a metalloprotease; heat inactivation 80–85 °C, 17 s–10 min, optionally followed by up to 140 °C / 0.5 s |
| 2.3.6.4 Amino acids | For equal energy value, available quantity of each indispensable and conditionally indispensable amino acid ≥ the reference protein in Section A of Annex III; Met+Cys and Phe+Tyr may be added together under the act’s rules (for IF, Art. 3(3) if ratio > 2) |
| L-carnitine | IF only: ≥ 0.3 mg/100 kJ (1.2 mg/100 kcal). FOF point 2.3.6.4 sets no L-carnitine minimum |
Annex III, Section A: the introductory sentence now also covers point 2.3.6 (alongside 2.1, 2.2, 2.3.2–2.3.5). That links the breast-milk amino-acid pattern to Group F — it is not a new value table.
4. Operator checklist before placing on the market
- Classify the product — IF or FOF (609/2013 + 2016/127). Group F does not cover FSMP or food supplements.
- Document source and process — skimmed cow’s milk + WPCs at 60:40; metalloprotease hydrolysis and heat inactivation per 2.3.6.3; a characterised pathway, not “any whey hydrolysate”.
- Keep the protein window — 2.3–2.8 g/100 kcal (0.55–0.67 g/100 kJ); the EFSA and act minima align at the lower bound.
- Check amino acids and L-carnitine — Section A of Annex III; for IF, L-carnitine ≥ 0.3 mg/100 kJ.
- Meet the rest of 2016/127 — Group F replaces only the hydrolysate protein block; other compositional and information rules remain.
- Separate communication — compositional compliance ≠ health claim, ≠ allergy risk-reduction claim, ≠ FSMP status.
5. Distinctions the market often confuses
- Group F ≠ every milk hydrolysate
- The listing authorises a specific pathway (60:40 source + metalloprotease + process parameters). A hydrolysate outside that characterisation needs its own EFSA assessment and a separate 2016/127 amendment (groups A–E already exist).
- EFSA opinion ≠ market decision
- e9278 underpins the Commission act; without 2026/743 there is no Group F entry in the annexes.
- IF/FOF composition ≠ health claim
- 1924/2006 requires a separate claim authorisation. Compliance with 2016/127 does not “unlock” a claim.
- IF/FOF ≠ FSMP
- This act concerns formulae under 609/2013/2016/127. Do not confuse with Reg. 2016/128 (including Art. 6(2) — ban on repeating FIC nutrition elements).
- Not novel food / not an additive
- A milk-protein hydrolysate in IF/FOF is a special-food composition pathway, not a Union novel-food list entry and not an additive authorisation under 1333/2008.
Conclusion
From 29 June 2026, Delegated Regulation (EU) 2026/743 opens the EU market for IF and FOF manufactured from the hydrolysate characterised as Group F: skimmed cow’s milk + whey protein concentrates (60:40), metalloprotease hydrolysis in a narrow pH/temperature window, protein 2.3–2.8 g/100 kcal, Section A amino-acid pattern, and L-carnitine in IF. Positive EFSA opinion e9278 was the scientific premise; the market decision is the Commission’s amendment of the 2016/127 annexes. An operator using this pathway must prove compliance with point 2.3.6 — a generic “hydrolysed milk” label is not enough.
Primary sources
- Commission Delegated Regulation (EU) 2026/743 — CELEX 32026R0743; ELI eli/reg_del/2026/743/oj; OJ 9.6.2026; EIF 29.06.2026.
- Commission Delegated Regulation (EU) 2016/127 — IF/FOF composition and information; CELEX 32016R0127.
- Regulation (EU) No 609/2013 — Art. 11(2) delegation; CELEX 32013R0609.
- EFSA NDA 2025 — protein hydrolysate (Healthcare Reckitt B.V.) — EFSA Journal 2025;23:e9278; Q-2019-00305; adopted 29.01.2025.
- EFSA NDA 2014 — essential composition of infant and follow-on formulae — DOI 10.2903/j.efsa.2014.3760.
- Regulation (EC) No 1924/2006 — nutrition and health claims (contrast: composition ≠ claim).