Monosodium salt of L-5-methyltetrahydrofolic acid is approved as a new source of folate in food supplements

On November 5, has been published Commission Regulation (EU) 2025/2224 amending Annex II to Regulation (EC) No 1925/2006 of the European Parliament and of the Council and Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards monosodium salt of L-5-methyltetrahydrofolic acid as a source of folic acid added to foods and as a source of folate used in the manufacture of food supplements .

The new ingredient was already approved in 2024 as a novel food in Commission Implementing Regulation (EU) 2024/1037 of 9 April 2024 authorising the placing on the market of monosodium salt of L-5-methyltetrahydrofolic acid as a novel food and amending Implementing Regulation (EU) 2017/2470.

The novel food is permitted in several food categories, including food supplements, and its designation on the labeling of food products containing it must be “Monosodium salt of L-5-methyltetrahydrofolic acid (folic acid)“.

The labeling of food supplements containing this new source of folate will include a statement indicating that they should not be consumed by infants or young children (under three years of age).

Only Merck & Cie KmG will be authorized to market the novel food in the EU for a period of 5 years from 30 April 2024, unless a subsequent applicant obtains authorization for that novel food without referring to the protected scientific data or having obtained the consent of Merck & Cie KmG.