EU Adopts Regulation (EU) 2025/2224 — 5 MTHF Monosodium Salt Authorized as Folate Source

On 5–6 November 2025, the European Commission adopted Regulation (EU) 2025/2224, adding L‑5‑methyltetrahydrofolic acid monosodium salt (5‑MTHF) to the list of authorized folic acid / folate sources for use in foods and dietary supplements. The decision is based on EFSA scientific opinion and is directly applicable in all EU Member States.

 

1. Legal Basis and Amendments

  • The Regulation amends Annex II to Regulation (EC) 1925/2006 (addition of vitamins, minerals, and other substances to foods) and Annex II to Directive 2002/46/EC (dietary supplements)
  • Entry “monosodium salt of L‑5‑methyltetrahydrofolic acid” is added as an authorized folic acid / folate source.
  • The amendment follows EFSA scientific opinion and public/expert consultation.
  • The Regulation enters into force on the twentieth day after publication in the Official Journal (26 November 2025).

 

2. EFSA Scientific Assessment

  • On 26 October 2023, EFSA’s NDA Panel published a scientific opinion assessing the safety of 5‑MTHF monosodium salt as a novel food and the bioavailability of folate derived from it.
  • Composition: chemically synthesized 5‑MTHF ≥95% (w/w), sodium 4–5% (w/w). Production, specifications, and stability pose no safety concerns.
  • Bioavailability: the salt dissociates in the digestive tract into Na⁺ and l‑methylfolate, which is absorbed; bioavailability is comparable to other authorized 5‑MTHF salts.
  • Conclusion: safe under proposed conditions, nutritionally adequate, and total intake within ULs does not pose risks.

 

3. Approval Process and Timeline

  • 26 October 2023 — EFSA adopted scientific opinion.
  • 9 April 2024 — Implementing Regulation (EU) 2024/1037 authorized 5‑MTHF monosodium salt as novel food.
  • 5–6 November 2025 — Commission Regulation (EU) 2025/2224 amended Annex II lists.
  • 26 November 2025 — Regulation becomes directly applicable in all Member States.

 

4. Current Folate Sources

Before the approval of 5‑MTHF monosodium salt, the EU had authorized several sources of folate:

  • Synthetic folic acid (pteroylmonoglutamic acid) — Regulation (EC) No 1925/2006, Annex II
  • Calcium L‑methylfolate — Regulation (EC) 1925/2006, Annex II, amended by Commission Regulation (EC) 1170/2009
  • (6S)‑5‑methyltetrahydrofolate Glucosamine salt (5‑MTHF‑glucosamine salt) — Commission Regulation (EU) 2015/414, Annex II

The current approval makes 5‑MTHF monosodium salt an additional authorized form of folic acid / folate, facilitating diversification of food and supplement formulations.

 

5. Applicable Food Categories

  • Fortified foods
  • Dietary supplements
  • Infant formula / follow-on formula
  • Processed cereal-based baby foods
  • Foods for special medical purposes
  • Total diet replacement for weight control

 

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