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

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