,"The European Commission has implemented Delegated Regulation (EU) 2025/2224, amending Annex II of Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC to officially recognize monosodium salt of L-5-methyltetrahydrofolic acid (5-MTHF) as an authorized source of folic acid in foods and as a source of folate for use in food supplements.
The amendment aligns EU law with the latest scientific evaluation and expands the options available to food and supplement manufacturers for folate fortification.
This decision follows the EFSA scientific opinion of 26 October 2023, issued under the novel food authorization framework (Regulation (EU) 2015/2283). EFSA concluded that 5-MTHF is safe under proposed conditions of use and provides bioavailable folate.
Based on EFSA’s favourable assessment and its prior authorization as a novel food (Implementing Regulation (EU) 2024/1037), the Commission determined that its use poses no safety concerns. As a result, the ingredient is now formally added to the positive lists of permitted vitamin sources in EU legislation, enabling its use in:
Fortified foods as a source of folic acid
Food supplements as a source of folate.
According to EFSA’s safety assessment: The intake of L-5-MTHF + other supplemental folate forms must be below the Tolerable Upper Intake Level (UL) for folate.
EFSA’s UL for combined supplemental folic acid / 5-MTHF is 1,000 µg/day for adults"
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