CELEX: 32017D1281
Language: en
Date: 2017-07-13 00:00:00
Title: Commission Implementing Decision (EU) 2017/1281 of 13 July 2017 authorising the placing on the market of L-ergothioneine as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2017) 4844)

15.7.2017   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 184/65
               
            COMMISSION IMPLEMENTING DECISION (EU) 2017/1281
      of 13 July 2017
      authorising the placing on the market of L-ergothioneine as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
      
         
            (notified under document C(2017) 4844)
         
      
      (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 25 July 2013, the company Tetrahedron made a request to the competent authorities of France to place synthetic L-ergothioneine (‘L-ergothioneine’) on the Union market as a novel food ingredient within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97. The application excluded from the use infants, young children, pregnant and lactating women.
               
            
                  (2)
               
               
                  On 19 February 2015, the competent food assessment body of France issued its initial assessment report. In that report it came to the conclusion that L-ergothioneine meets the criteria for novel food ingredient set out in Article 3(1) of Regulation (EC) No 258/97.
               
            
                  (3)
               
               
                  On 9 March 2015, the Commission forwarded the initial assessment report to the other Member States.
               
            
                  (4)
               
               
                  Reasoned objections were raised by other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97.
               
            
                  (5)
               
               
                  On 14 October 2015, the Commission consulted the European Food Safety Authority (‘EFSA’) asking it to carry out an additional assessment for L-ergothioneine as novel food ingredient in accordance with Regulation (EC) No 258/97.
               
            
                  (6)
               
               
                  On 26 October 2016, EFSA in its ‘Scientific Opinion on the safety of L-ergothioneine as a novel food pursuant to Regulation (EC) No 258/97’ (2) concluded that L-ergothioneine is safe for the proposed uses and use levels.
               
            
                  (7)
               
               
                  That opinion gives sufficient grounds to establish that L-ergothioneine in the proposed uses and use levels 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 requirements on food supplements. The use of L-ergothioneine should be authorised without prejudice to the provisions of that Directive.
               
            
                  (9)
               
               
                  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
      Without prejudice to Directive 2002/46/EC, L-ergothioneine as specified in Annex I may be placed on the Union market as a novel food ingredient to be used in food supplements intended for the general population, excluding infants and young children, and pregnant and lactating women, for the uses defined and at the maximum levels established in Annex II.
      Article 2
      The designation of L-ergothioneine authorised by this Decision on the labelling of the foodstuffs shall be ‘L-ergothioneine’.
      Article 3
      This Decision is addressed to Tetrahedron, 14, avenue de l'Opéra, 75001 Paris, France.
      
         Done at Brussels, 13 July 2017.
         
            
               For the Commission
            
            Vytenis ANDRIUKAITIS
            
               Member of the Commission
            
         
      
      
         (1)  OJ L 43, 14.2.1997, p. 1.
      
         (2)  EFSA Journal 2016;14(11):4629.
      
         (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 I
         
            SPECIFICATIONS OF L-ERGOTHIONEINE
         
         
            Definition
         
         
                     Chemical name (IUPAC)
                  
                  
                     (2S)-3-(2-thioxo-2,3-dihydro-1H-imidazol-4-yl)-2-(trimethylammonio)-propanoate
                  
               
                     Chemical formula
                  
                  
                     C9H15N3O2S
                  
               
                     Molecular mass
                  
                  
                     229,3 Da
                  
               
                     CAS No
                  
                  
                     497-30-3
                  
               
                     IUPAC: International Union for Pure and Applied Chemistry
                  
               
            Specifications
         
         
                     Parameter
                  
                  
                     Specification
                  
                  
                     Method
                  
               
                     Appearance
                  
                  
                     White powder
                  
                  
                     Visual
                  
               
                     Optical rotation
                  
                  
                     [α]D ≥ (+) 122° (c = 1, H20) (1)
                     
                  
                  
                     Polarimetry
                  
               
                     Chemical purity
                  
                  
                     ≥ 99,5 %
                  
                  
                     HPLC [Eur. Ph. 2.2.29]
                  
               
                     ≥ 99 %
                  
                  
                     1H-NMR
                  
               
                     Identification
                  
                  
                     Compliant with the structure
                  
                  
                     1H-NMR
                  
               
                     C: 47,14 ± 0,4 %
                  
                  
                      
                  
               
                     H: 6,59 ± 0,4 %
                  
                  
                      
                  
               
                     N: 18,32 ± 0,4 %
                  
                  
                     Elemental analysis
                  
               
                     Total residual solvents
                     (methanol, ethyl acetate, isopropanol, ethanol)
                  
                  
                     [Eur. Ph. 01/2008:50400]
                     < 1 000  ppm
                  
                  
                     Gas chromatography
                     [Eur. Ph. 01/2008:20424]
                  
               
                     Loss on drying
                  
                  
                     Internal standard < 0,5 %
                  
                  
                     [Eur. Ph. 01/2008:20232]
                  
               
                     Impurities
                  
                  
                     < 0,8 %
                  
                  
                     HPLC/GPC or 1H-NMR
                  
               
                     
                        Heavy metals
                         (2)
                         (3)
                     
                  
               
                     Lead
                  
                  
                     < 3 ppm
                  
                  
                     ICP/AES
                     (Pb, Cd)
                     Atomic fluorescence (Hg)
                  
               
                     Cadmium
                  
                  
                     < 1 ppm
                  
               
                     Mercury
                  
                  
                     < 0,1 ppm
                  
               
                     
                        Microbiological specifications
                         (2)
                     
                  
               
                     Total viable aerobic count (TVAC)
                  
                  
                     ≤ 1 × 103 CFU/g
                  
                  
                     [Eur. Ph. 01/2011:50104]
                  
               
                     Total yeast and mould count (TYMC)
                  
                  
                     ≤ 1 × 102 CFU/g
                  
               
                     Escherichia coli
                  
                  
                     Absent in 1 g
                  
               
                     Eur. Ph.: European Pharmacopoeia; 1H-NMR: proton nuclear magnetic resonance; HPLC: high-performance liquid chromatography; GPC: gel permeation chromatography; ICP/AES: Inductively coupled plasma atomic emission spectroscopy;
                     CFU: colony-forming units.
                  
               
            (1)  Lit. [α]D = (+) 126,6° (c = 1, H20)
         
            (2)  Analyses conducted on each batch
         
            (3)  Maximum levels in accordance with Commission Regulation (EC) No 1881/2006 (OJ L 364, 20.12.2006, p. 5).
      
      
         ANNEX II
         
            AUTHORISED USES OF L-ERGOTHIONEINE
         
         
                     Food category
                  
                  
                     Maximum levels
                  
               
                     Food supplements as defined in Directive 2002/46/EC
                  
                  
                     30 mg/day for general population (excluding pregnant and lactating women)
                     20 mg/day for children older than 3 years