Commission Implementing Decision (EU) 2016/1344

of 4 August 2016

authorising the placing on the market of organic silicon (monomethylsilanetriol) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document C(2016) 4975)

(Only the English text is authentic)

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 ingredients1, and in particular Article 7 thereof,

Whereas:

(1)

On 27 March 2013, the company LLR-G5 Ltd made a request to the competent authorities of Ireland to place organic silicon (monomethylsilanetriol) on the market as a novel food ingredient within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97.

(2)

On 17 April 2013, the competent food assessment body of Ireland issued its initial assessment report. In that report it came to the conclusion that an additional assessment was required in line with Article 6(3) of the novel food Regulation (EC) No 258/97.

(3)

On 26 April 2013, the Commission forwarded the initial assessment report to the other Member States.

(4)

On 10 October 2013, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for organic silicon (monomethylsilanetriol) as novel food ingredient in accordance with Regulation (EC) No 258/97.

(5)
On 9 March 2016, EFSA concluded in its opinion on the safety of organic silicon (monomethylsilanetriol, MMST) as a novel food ingredient for use as a source of silicon in food supplements and bioavailability of orthosilicic acid from the source2, that organic silicon (monomethylsilanetriol) is safe under the proposed conditions of use.
(6)

That opinion gives sufficient grounds to establish that organic silicon (monomethylsilanetriol) as a novel food ingredient complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

(7)
Directive 2002/46/EC of the European Parliament and of the Council3 lays down requirements on food supplements. The use of organic silicon (monomethylsilanetriol) should be authorised without prejudice to the requirements of this legislation.
(8)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS DECISION:

Article 1

Organic silicon (monomethylsilanetriol) as specified in the Annex to this Decision may be placed on the market in the Union as a novel food ingredient to be used in food supplements in liquid form intended for the adult population with a maximum dose of 10,40 mg silicon per day as recommended by the manufacturer without prejudice to the specific provisions of Directive 2002/46/EC.

Article 2

The designation of organic silicon (monomethylsilanetriol) authorised by this Decision for the labelling of the foodstuffs shall be ‘organic silicon (monomethylsilanetriol)’.

Article 3

This Decision is addressed to LLR-G5 Ltd, Golden Mile Industrial Park, Breaffy Road, Castlebar, Co. Mayo, F23 VX58, Ireland.

Done at Brussels, 4 August 2016.

For the Commission

Vytenis Andriukaitis

Member of the Commission

ANNEXSPECIFICATION OF ORGANIC SILICON (MONOMETHYLSILANETRIOL)

Identity of organic silicon (monomethylsilanetriol)

Chemical name

Silanetriol, 1-methyl-

Chemical formula

CH6O3Si

Molecular weight

94,14 g/mol

CAS No

2445-53-6

Organic silicon (monomethylsilanetriol) preparation (aqueous solution)

Parameters

Specification value

Acidity (pH)

6,4-6,8

Silicon

100-150 mg Si/l

Lead

Not more than 1 μg/l

Mercury

Not more than 1 μg/l

Cadmium

Not more than 1 μg/l

Arsenic

Not more than 3 μg/l

Methanol

Not more than 5 mg/kg (residual presence)