# Commission Implementing Decision of 19 March 2014 authorising the placing on the market of (6S)-5-methyltetrahydrofolic acid, glucosamine salt as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2014) 1683) (Only the Italian text is authentic) (2014/154/EU), Annex: SPECIFICATION OF (6S)-5-METHYLTETRAHYDROFOLIC ACID, GLUCOSAMINE SALT

Extent: E+W+S+N.I.

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.
1181972-37-1
Purity:
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 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 ppm
Microbiological 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

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Source: https://www.legislation.gov.uk/eudn/2014/154/annex (the official version)
Page: https://openlegislation.uk/eu-decision-2014-154/annex
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.