(6S)-5-methyltetrahydrofolic acid, glucosamine salt: 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:

• Food Supplements as defined in Directive 2002/46/EC as a source of folate

Specification (Table 2)

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

Description/Definition:

Chemical 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, glucosamine salt

Chemical formula: C32H51N9O16

Molecular weight: 817,80 g/mol (anhydrous)

CAS No.: 1181972-37-1

Appearance: Creamy to light-brown powderPurity:

Diastereoisomeric purity: At least 99 % of (6S)-5-methyltetrahydrofolic acid

Glucosamine assay: 34-46 % in dry basis

5-Methyltetrahydrofolic acid assay: 54-59 % in dry basis

Water: ≤ 8,0 %

Heavy metals:

Lead: ≤ 2,0 ppm

Cadmium: ≤ 1,0 ppm

Mercury: ≤ 0,1 ppm

Arsenic: ≤ 2,0 ppm

Boron: ≤ 10 ppm

Microbiological criteria:

Total aerobic microbial count: ≤ 100 CFU/g

Yeasts and moulds: ≤ 100 CFU/g

Escherichia coli: Absence in 10g

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

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