Calcium L-Methylfolate: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Foods for special medical purposes and total diet replacement for weight control as defined in Regulation (EU) No 609/2013: In accordance with Regulation (EU) No 609/2013
• Infant formulae and follow-on formula as defined by Regulation (EU) No 609/2013: In accordance with Regulation (EU) No 609/2013
• Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013: In accordance with Regulation (EU) No 609/2013
• Food supplements as defined in Directive 2002/46/EC: In accordance with Directive 2002/46/EC
• Food fortified in accordance with Regulation (EC) No 1925/2006: In accordance with Regulation (EC) No 1925/2006

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Calcium L-Methylfolate’.

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description:

The novel food is produced by chemical synthesis starting from folic acid.

It is a white to light yellowish, almost odourless, crystalline powder, sparingly soluble in water and very slightly soluble or insoluble in most organic solvents.

Definition:

Chemical formula: C20H23CaN7O6

Systematic name: N-{4-[[((6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl)methyl]amino]benzoyl}-L-glutamic acid, calcium salt.

CAS Numbers: 129025-21-4 (Calcium salt with an unspecified ratio of L-5-MTHF/Ca2+) and 151533-22-1 (Calcium salt with specified 1:1 ratio of L-5-MTHF/Ca2+).

Molecular weight: 497,5 Daltons

Synonyms: L-methylfolate, calcium; L-5-methyltetrahydrofolic acid, calcium salt [(L-5-MTHF-Ca)]; (6S)-5-methyltetrahydrofolic acid, calcium salt [(6S)-5-MTHF-Ca]; (6S)-5-methyl-5,6,7,8-tetrahydropteroyl-L-glutamic acid, calcium salt, and L-5-methyl-tetrahydrofolic acid (L-5-MTHF) without the cation specified.

Structural formula:

Characteristics

Purity: > 95 % (Dry basis)

Water: ≤ 17,0 %

Calcium (on anhydrous and solvent free basis): 7,0 - 8,5 %

Calcium D-methylfolate (6R, αS isomer): ≤ 1,0 %

Other folates and related substances: ≤ 2,5 %

Ethanol: ≤ 0,5 %

Contaminants

CFU: colony forming units

Infants and young children

General population excluding infants and young children

Lead: ≤ 1 mg/kg

Lead: ≤ 1 mg/kg

Boron: ≤ 10 mg/kg

Boron: ≤ 10 mg/kg

Cadmium ≤ 0,5 mg/kg

Cadmium ≤ 0,5 mg/kg

Mercury ≤ 1,0 mg/kg

Mercury ≤ 1,5 mg/kg

Arsenic ≤ 1,5 mg/kg

Arsenic ≤ 1,5 mg/kg

Platinum ≤ 2 mg/kg

Platinum ≤ 10 mg/kg

Microbiological criteria:

Total viable aerobic counts: ≤ 1 000 CFU/g

Total yeast and mould count: ≤ 100 CFU/g

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

Want the whole list as one table?

If we publish the Union list as one table (name, food category, maximum level), we write to you once. We use the email for nothing else.