THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients(1), and in particular Article 7 thereof,
Whereas:
(1) 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.
(2) 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.
(3) On 28 February 2012, the Commission forwarded the initial assessment report to the other Member States.
(4) 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.
(5) 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.
(6) On 11 September 2013, EFSA adopted a Scientific Opinion on (6S)-5-methyltetrahydrofolic acid, glucosamine salt as a source of folate added for nutritional purposes to food supplements(2), concluding that (6S)-5-methyltetrahydrofolic acid, glucosamine salt is not of safety concern as a source of folate.
(7) 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.
(8) Directive 2002/46/EC of the European Parliament and of the Council(3), lays down specific provisions for the use of vitamins and minerals in food supplements. The use of (6S)-5-methyltetrahydrofolic acid, glucosamine salt should be authorised without prejudice to the requirements of this legislation.
(9) 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:
(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.
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’.
This Decision is addressed to Gnosis SpA, Via Lavoratori Autobianchi 1, 20832 Desio (MB), Italy.
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 |
Textual Amendments
F1 Substituted by Commission Implementing Decision of 15 December 2014 correcting the Annex to Implementing Decision 2014/154/EU 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) 9452) (Only the Italian text is authentic) (2014/916/EU).
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 |
EFSA Journal 2013;11(10):3358.
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).