# 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)         

        - Previous
        - Next

U.K.

# 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 1U.K.

(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 2U.K.

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 3U.K.

This Decision is addressed to Gnosis SpA, Via Lavoratori Autobianchi 1, 20832 Desio (MB), Italy.

## ANNEXU.K.**SPECIFICATION OF (6S)-5-METHYLTETRAHYDROFOLIC ACID, GLUCOSAMINE SALT**

**Definition:**                   

**Description:** Creamy to light-brown powder.                  

**Identification:**                   

**Purity:**                   

Textual Amendments

F1Substituted 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:**                   

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).