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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
On 28 July 2011, the company Gnosis SpA made a request to the competent authorities of Ireland to place (6S)-5-methyltetrahydrofolic acid, glucosamine salt on the market as a novel food ingredient for use in food supplements.
On 26 October 2011, the competent food assessment body of Ireland issued its initial assessment report. In that report it came to the conclusion that (6S)-5-methyltetrahydrofolic acid, glucosamine salt meets the criteria set out in Article 3(1) of Regulation (EC) No 258/97.
On 28 February 2012, the Commission forwarded the initial assessment report to the other Member States.
Reasoned objections were raised within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97.
On 14 September 2012 and on 5 March 2013 the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for (6S)-5-methyltetrahydrofolic acid, glucosamine salt as food ingredient in accordance with Regulation (EC) No 258/97.
The opinion gives sufficient grounds to establish that (6S)-5-methyltetrahydrofolic acid, glucosamine salt as a source of folate complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DECISION:
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.
ANNEXSPECIFICATION OF (6S)-5-METHYLTETRAHYDROFOLIC ACID, GLUCOSAMINE SALT
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 |
F1Glucosamine 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 |