
Article 1 
(6S)-5-methyltetrahydrofolic acid, glucosamine salt as a source of folate as specified in the Annex may be placed on the market in the Union as a novel food ingredient to be used in food supplements without prejudice to the specific provisions of Directive 2002/46/EC.
Article 2 
The designation of (6S)-5-methyltetrahydrofolic acid, glucosamine salt, authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘(6S)-5-methyltetrahydrofolic acid, glucosamine salt’ or ‘5MTHF-glucosamine’.
Article 3 
This Decision is addressed to Gnosis SpA, Via Lavoratori Autobianchi 1, 20832 Desio (MB), Italy.
Done at Brussels, 19 March 2014.
For the Commission
Tonio BORG
Member of the Commission
ANNEX

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)Description: Creamy to light-brown powder.
Identification:

CAS No. 1181972-37-1Purity:

Diastereoisomeric purity At least 99 % of (6S)-5-methyltetrahydrofolic acid
Glucosamine assay 34-36 % in dry basis
5-Methyltetrahydrofolic acid assay 54-59 % in dry basis
Water content Not more than 8,0 %
Lead Not more than 2,0 ppm
Cadmium Not more than 1,0 ppm
Mercury Not more than 0,1 ppm
Arsenic Not more than 2,0 ppm
Boron Not more than 10 ppmMicrobiological criteria:

Total aerobic microbial count Not more than 100 cfu/g
Total combined yeast and moulds Not more than 100 cfu/g
Escherichia coli Absent in 10 g