CELEX: 32016D1344
Language: en
Date: 2016-08-04 00:00:00
Title: 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)

6.8.2016   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 213/12
            
         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 ingredients (1), 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 source (2), 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 Council (3) 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
         
      
   
   
      (1)  OJ L 43, 14.2.1997, p. 1.
   
      (2)  EFSA Journal 2016;14(4):4436
   
      (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 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)