EU Approves New Folate Source for Supplements

The EU Commission has authorized monosodium L-5-methyltetrahydrofolate as a new folate source for food supplements.

# EU Approves New Folate Source for Supplements

The EU Commission authorized a new, bioactive folate source for food supplements on November 5, 2025.

The Innovation

New Authorized Source - **Monosodium salt of L-5-methyltetrahydrofolic acid** - **Regulation (EU) 2025/2224** - **Effective since:** November 5, 2025

Legal Basis - Amends Annex II of Directive 2002/46/EC - Based on EFSA Scientific Opinion from October 26, 2023 - Applies to all EU Member States

Benefits for Manufacturers

Bioactive Form - Directly usable folate form - No body conversion needed - Especially suitable for MTHFR polymorphisms

Application Areas - Prenatal supplements - B-vitamin complexes - Multivitamin preparations

Technical Specifications

Requirements - Purity criteria per EFSA Opinion - Stability studies required - GMP-compliant manufacturing

Dosage Guidelines - Folate equivalence: 1:1 to folic acid - Maximum dose: 200 µg/day (BfR recommendation) - Labeling as "Folate" or "Folic Acid"

Check Your Formulations

With Supplement-Check.eu: - Validate new folate sources - Check EU-wide compliance - Verify 28 countries simultaneously

Source: [EUR-Lex Regulation 2025/2224](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:L_202502224)

*Created: November 5, 2025 • Last updated: November 5, 2025*

*Hinweis: Diese Zusammenfassung dient Informationszwecken. Die dargestellten Studienergebnisse sind keine zugelassenen Health Claims. Für detaillierte Informationen konsultieren Sie bitte die Originalquelle.