Monosodium salt of 5-MTHF as source of folate
- Food safety
- Food supplements/dietetic foods
Summary
The European Commission has informed the World Trade Organization Technical Barriers to Trade (WTO TBT) Committee that it intends to authorise the use of monosodium salt of L-5-methyltetrahydrofolic acid (5-MTHF), a source of folate, in infant formula and follow-on formula, baby and weight control foods, and foods for special medical purposes.
The Commission has also informed the WTO TBT Committee that, based on its authorisation as a novel food, it intends to include 5-MTHF in the list of vitamin and mineral substances that may be used in the manufacture of food supplements (Annex II to Directive 2002/46/EC), and in the list of vitamins and minerals that may be added to foods (Annex II to Regulation 1925/2006).
European Commission proposes to allow monosodium salt of L-5-methyltetrahydrofolic acid (5-MTHF) in foods and food supplements
Draft Commission Delegated Regulation amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council to allow the use of monosodium salt of L-5-methyltetrahydrofolic acid as a source of folate in infant formula and follow-on formula, processed cereal-based food and baby food, total diet replacement for weight control and in food for special medical purposes
Draft Commission Regulation 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
Update
The European Commission has informed the World Trade Organization Technical Barriers to Trade (WTO TBT) Committee that it intends to authorise the use of monosodium salt of L-5-methyltetrahydrofolic acid (5-MTHF), a source of folate, in infant formula and follow-on formula, baby and weight control foods, and foods for special medical purposes.
The Commission has also informed the WTO TBT Committee that, based on its authorisation as a novel food, it intends to include 5-MTHF in the list of vitamin and mineral substances that may be used in the manufacture of food supplements (Annex II to Directive 2002/46/EC), and in the list of vitamins and minerals that may be added to foods (Annex II to Regulation 1925/2006).
Impacted Products
Infant formula, follow-on formula, processed cereal-based food, baby food, total diet replacement for weight control, food for special medical purposes
What is changing?
The European Commission proposes to authorise the use of monosodium salt of 5-MTHF as a source of folic acid in the following categories of food:
- infant formula and follow-on formula
- processed cereal-based food and baby food
- total diet replacement for weight control
- food for special medical purposes.
The substance must also be included in the Union list of substances allowed in these categories of food (Regulation 609/2013).
The Commission also intends to include 5-MTHF in the list of vitamin and mineral substances that may be used in the manufacture of food supplements (Annex II to Directive 2002/46/EC), and in the list of vitamins and minerals that may be added to foods (Annex II to Regulation 1925/2006).
Why?
The European Food Safety Authority has concluded that monosodium salt of 5-MTHF is a safe source from which folate is bioavailable (EFSA 2023).
Timeline
The Regulations are expected to be adopted in approximately the third quarter of 2025.
Recommended Actions
Competent authorities of non-EU countries that are WTO members may comment on the EU proposals by emailing the EU TBT Enquiry Point until 4 May 2025 (G/TBT/N/EU/1111) and 12 May 2025 (G/TBT/N/EU/1115).
Background
Folic acid is the synthetic version of the vitamin folate, also known as vitamin B9. L-5-methyltetrahydrofolic acid (5-MTHF) is a form of folic acid that becomes more bioavailable when present in active form.
EFSA (2023) assessed the bioavailability of various forms of folate added to food. Annex II of Directive 2002/46/EC lists folic acid as authorised for use in foods in the EU.
Regulation 2024/1037 authorises 5-MTHF to be placed on the EU market as a novel food, and to be included in the Union list of novel foods (Regulation 2017/2470).
Resources
EFSA (2023) Safety of monosodium salt of l‐5‐methyltetrahydrofolic acid as a novel food pursuant to Regulation (EU) 2015/2283 and the bioavailability of folate from this source in the context of Directive 2002/46/EC, Regulation (EU) No 609/2013 and Regulation (EC) No 1925/2006. EFSA Journal, 21: e8417.
Sources
Draft Commission Delegated Regulation to allow the use of monosodium salt of L-5-methyltetrahydrofolic acid as a source of folate in infant formula and follow-on formula, processed cereal-based food and baby food, total diet replacement for weight control and in food for special medical purposes
Draft Commission Regulation 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
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European Commission proposes to allow monosodium salt of L-5-methyltetrahydrofolic acid (5-MTHF) in foods and food supplements
Draft Commission Delegated Regulation to allow the use of monosodium salt of L-5-methyltetrahydrofolic acid as a source of folate in infant formula and follow-on formula, processed cereal-based food and baby food, total diet replacement for weight control and in food for special medical purposes
Draft Commission Regulation 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
What is changing and why?
The European Commission proposes to authorise the use of L-5-methyltetrahydrofolic acid (5-MTHF), a source of the vitamin folate (also known as vitamin B9), in specific categories of food: infant formula and follow-on formula, processed cereal-based food and baby food, total diet replacement for weight control, and food for special medical purposes.
Because 5-MTHF is already authorised as a novel food, the Commission also intends to include the substance in the list of vitamins and minerals that may be used in the manufacture of food supplements, and in the list of those that may be added to foods.
Actions
Competent authorities of non-EU countries that are members of the World Trade Organization may comment on the EU proposals by emailing the EU TBT Enquiry Point until 4 May 2025 (G/TBT/N/EU/1111) and 12 May 2025 (G/TBT/N/EU/1115).
Timeline
The Regulations are expected to be adopted in approximately the third quarter of 2025.
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.