Monosodium salt of L-5-methyltetrahydrofolic acid: authorised novel food in the EU
Monosodium salt of L-5-methyltetrahydrofolic acid is on the Union list of authorised novel foods (Implementing Regulation (EU) 2017/2470). Conditions of use and maximum levels by food category: 6 entries, quoted below.
- Regulation
- Implementing Regulation (EU) 2017/2470, Annex, Table 1
- Listed as
- Monosodium salt of L-5-methyltetrahydrofolic acid
- Text version
- Consolidated text of 10 August 2026
- Version
- Consolidated text of 10 August 2026
- Official source
- Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods
Conditions of use and maximum levels
Table 1, column "Conditions under which the novel food may be used", as written:
- Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children: In accordance with Directive 2002/46/EC
- Infant formula and follow-on formula as defined in 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 in Regulation (EU) No 609/2013: In accordance with Regulation (EU) No 609/2013
- Foods for special medical purposes as defined in Regulation (EU) No 609/2013: In accordance with Regulation (EU) No 609/2013
- Total diet replacement for weight control as defined in Regulation (EU) No 609/2013: In accordance with Regulation (EU) No 609/2013
- Food fortified in accordance with Regulation (EC) No 1925/2006: In accordance with Regulation (EC) No 1925/2006
Additional specific labelling requirements
1. The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Monosodium salt of L-5-methyltetrahydrofolic acid (folic acid)’. 2. The labelling of food supplements containing monosodium salt of L-5-methyltetrahydrofolic acid shall bear a statement that the food supplements should not be consumed by infants and young children (children under 3 years of age)
Specification (Table 2)
Table 2 of the Annex, row with the same name, as written:
Description/Definition:
The novel food is produced by chemical synthesis and consists of L-5-methyltetrahydrofolic acid.
Molecular formula: C20H24N7NaO6
Chemical name: N-[4-[[(2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-(6S)-pteridinyl)methyl]amino]benzoyl]-l-glutamic acid
CAS number: 2246974-96-7
Molecular weight: 481,44 g/mol
Characteristics/composition:
Appearance: White to yellow or beige powder
Assay & related compounds: Assay 5-MeTHFA-Na on dry basis: > 95 %; Sum of folate-related substances: ≤ 2,5
Sodium: 4 %-5 % w/w
Water: ≤ 1,0 %
Residual solvents: Ethanol: ≤ 0,5 %; Isopropanol: ≤ 0,5 %
Diastereomeric purity: (6R)-Mefolinate: ≤ 1,0 % area
Elemental impurities:
Boron: ≤ 10 mg/kg
Platinum: ≤ 10 mg/kg (for foods intended for infants and young children and food supplements intended for pregnant women then ≤ 2 mg/kg)
Arsenic: ≤ 1,5 mg/kg
Cadmium: ≤ 0,5 mg/kg
Lead: ≤ 1,0 mg/kg
Mercury: ≤ 1,5 mg/kg (for foods intended for infants and young children and food supplements intended for pregnant women then ≤ 1 mg/kg)
Microbiological criteria:
Total aerobic microbial count: ≤ 100 CFU/g
Total yeast and moulds count: ≤ 100 CFU/g
E. coli: Not detected in 10 g
Abbreviations: CFU: colony forming unit; IR: infra-red; MeTHFA: methyltetrahydrofolic acid.
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.
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