Folate (Vitamin B9 / 5-MTHF)
INCI: Folate (5-MTHF)
Folate (5-MTHF) is the bioactive, reduced form of vitamin B9, also known as methylfolate or L-methylfolate. It is the form of folate that is directly usable by the body without requiring enzymatic conversion. Under EU Regulation 432/2012, folate carries eight authorised health claims including contributions to normal blood formation, homocysteine metabolism, psychological function, immune function, reduction of tiredness and fatigue, cell division, and maternal tissue growth during pregnancy.
- pregnancy-support
- energy-metabolism
- nervous-system
At a glance
- Definition
- Folate (5-MTHF) is the bioactive, reduced form of vitamin B9, also known as methylfolate or L-methylfolate. It is the form of folate that is directly usable by the body without requiring enzymatic conversion. Under EU Regulation 432/2012, folate carries eight authorised health claims including contributions to normal blood formation, homocysteine metabolism, psychological function, immune function, reduction of tiredness and fatigue, cell division, and maternal tissue growth during pregnancy.
- Authorised wording (summary)
- 8 authorised statements — see "EU-authorised health claims" below.
- Common gummy positionings
- prenatal and maternal health
- energy metabolism
- nervous system function
- homocysteine metabolism
- blood formation
- Format suitability
- Suitable for gummy formats — confirmed per project.
What it is
Folate (5-MTHF) is the biologically active form of vitamin B9, also referred to as L-methylfolate or levomefolic acid. Unlike folic acid, which requires conversion by the enzyme MTHFR in the body, 5-MTHF is already in its active coenzyme form and can be used directly for methylation, DNA synthesis, and homocysteine regulation. This makes it particularly relevant for individuals with genetic polymorphisms in the MTHFR gene, which can impair the conversion of folic acid.
Brands choose 5-MTHF over folic acid for its superior bioavailability and suitability across a broader population. It is one of the most familiar and commercially understood B-vitamin actives across EU and US markets, especially in prenatal, maternal health, and energy-support formulations. Under EU Regulation 432/2012, folate carries eight authorised health claims, making it a versatile ingredient for gummy and sachet products targeting pregnancy support, energy metabolism, and nervous system function.
Origin and history
Folate is a water-soluble B vitamin found naturally in leafy green vegetables, legumes, and liver. The synthetic form, folic acid, was first developed in the 1940s and has been used for decades in food fortification and supplements. However, research in the late 1990s and early 2000s revealed that a significant portion of the population carries genetic variants in the MTHFR gene that reduce the efficiency of converting folic acid into its active form, 5-MTHF.
The development of stabilised 5-MTHF as a supplement ingredient began in the early 2000s, with calcium and glucosamine salt forms being commercialised for use in food supplements. Today, 5-MTHF is produced industrially through chemical synthesis or enzymatic conversion, yielding a pure, stabilised crystalline powder suitable for use in gummies, sachets, and other supplement formats. Its adoption has grown steadily, particularly in prenatal and personalised nutrition products.
Scientific overview
Folate functions as a coenzyme in one-carbon metabolism, which is essential for DNA synthesis, repair, and methylation. It acts as a methyl donor in the conversion of homocysteine to methionine, a process that is critical for cardiovascular health and nervous system function. 5-MTHF, as the active form, bypasses the MTHFR enzyme step and enters directly into the methylation cycle, making it more bioavailable for individuals with reduced enzyme activity.
The bioavailability of 5-MTHF is generally considered superior to folic acid, particularly in populations with MTHFR polymorphisms. Studies show that 5-MTHF is absorbed efficiently and raises serum folate levels comparably to or better than equivalent doses of folic acid. The calcium salt form is the most common in supplements, offering good stability and solubility for gummy manufacturing.
From a manufacturing perspective, 5-MTHF is heat-sensitive and should be handled with care during gummy processing to avoid degradation. It is soluble in water and can be incorporated into gummy formulations without significant taste issues at typical doses. The cost-per-mg is higher than folic acid, reflecting the more complex production process and higher purity requirements. DAT reviews formulation stability per project to confirm final shelf-life claims.
Why brands use Folate (Vitamin B9 / 5-MTHF) in gummies
Folate (5-MTHF) is a strong positioning ingredient for gummy products targeting prenatal and maternal health, energy metabolism, and nervous system support. Its eight authorised EU health claims provide a robust foundation for pack copy and marketing, particularly for brands targeting women of childbearing age, athletes, and individuals seeking cognitive or cardiovascular support. The ingredient is one of the most familiar and commercially understood B-vitamin actives across EU and US markets, making it a trusted choice for brand founders.
In gummy manufacturing, 5-MTHF presents manageable formulation tradeoffs. It is heat-sensitive, so processing temperatures must be controlled to preserve potency. It is soluble in water and has a neutral taste at supplement doses, which simplifies flavour masking. The higher cost compared to folic acid is offset by the premium positioning and broader consumer appeal. DAT confirms the final formulation and stability profile per project.
For pack copy, brands should use EFSA-authorised claim wording verbatim for EU markets. Claims such as "Folate contributes to normal maternal tissue growth during pregnancy" and "Folate contributes to the reduction of tiredness and fatigue" are directly applicable. No disease claims are permitted. Certification promises (vegan, kosher, halal) and shelf-life claims are confirmed per project and batch documentation. DAT reviews all claim wording per project and market.
Gummy formulation notes
Verified formulation reference. Final formulation, dose and on-pack copy are confirmed per project.
- Gummy fit
- Good
- Heat stable
- Limited — use coated forms
- Soluble in matrix
- Yes
- Cost tier
- Premium
Forms available
- L-methylfolate calcium salt
- L-methylfolate glucosamine salt
- folic acid (for comparison)
Dosage reference
EU NRV for folate is 200 µg. Brand positioning typically ranges from 200 µg to 800 µg per serving. The 5-MTHF form is used at lower doses than folic acid due to higher bioavailability.
Taste & sensory
Neutral to mild taste at supplement doses.
Manufacturing notes
No specific formulation notes. Standard processing applies.
EU-authorised health claims
- Folate contributes to normal amino acid synthesis.Reg. (EU) 432/2012
- Folate contributes to normal blood formation.Reg. (EU) 432/2012
- Folate contributes to normal homocysteine metabolism.Reg. (EU) 432/2012
- Folate contributes to normal psychological function.Reg. (EU) 432/2012
- Folate contributes to normal function of the immune system.Reg. (EU) 432/2012
- Folate contributes to the reduction of tiredness and fatigue.Reg. (EU) 432/2012
- Folate has a role in the process of cell division.Reg. (EU) 432/2012
- Folate contributes to normal maternal tissue growth during pregnancy.Reg. (EU) 432/2012
Authorised at ≥15% NRV per daily serving. Claim wording must appear verbatim on consumer packaging. DAT reviews final pack copy per project against EU 1924/2006 and the authorised list under EU 432/2012.
Folate (5-MTHF) is an authorised nutrient under EU Reg. 1925/2006 and Reg. 432/2012. The 5-MTHF form is the bioactive, reduced form of folate and is permitted for use in food supplements. All authorised health claims listed above apply to folate as a nutrient. DAT confirms claim wording per project and market.
Studies & evidence
External peer-reviewed sources and regulatory opinions. Citations only — DAT does not endorse the publishers.
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)·EFSA Journal·2009
Smith AD, Refsum H·Nutrients·2016
Papakostas GI, Shelton RC, Zajecka JM, et al.·Journal of Clinical Psychiatry·2012
Pietrzik K, Bailey L, Shane B·American Journal of Clinical Nutrition·2010
- [05] Commission Regulation (EU) No 432/2012 establishing a list of permitted health claims made on foods
European Commission·Official Journal of the European Union·2012
Synergies & conflicts
Pairs well with
Synergy data needs review. DAT reviews per project.
Care when combining with
Conflict data needs review. DAT reviews per project.
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References
- Scientific Opinion on the substantiation of health claims related to folate — EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), EFSA Journal, 2009.
- Folate and vitamin B12: a review of their roles in one-carbon metabolism and health — Smith AD, Refsum H, Nutrients, 2016.
- L-methylfolate: a review of its clinical efficacy in the treatment of depression — Papakostas GI, Shelton RC, Zajecka JM, et al., Journal of Clinical Psychiatry, 2012.
- Bioavailability of L-methylfolate vs folic acid in healthy adults — Pietrzik K, Bailey L, Shane B, American Journal of Clinical Nutrition, 2010.
- Commission Regulation (EU) No 432/2012 establishing a list of permitted health claims made on foods — European Commission, Official Journal of the European Union, 2012.