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

21.3.2014 | EN | Official Journal of the European Union | L 85/10 ---|---|---|--- * * * 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, 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: 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 * * * (1) OJ L 43, 14.2.1997, p. 1. (2) EFSA Journal 2013;11(10):3358. (3) 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). * * * ANNEX SPECIFICATION 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 ---|--- 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 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 * * *