CELEX: 32013D0705
Language: en
Date: 2013-11-29 00:00:00
Title: 2013/705/EU: Commission Implementing Decision of 29 November 2013 authorising the placing on the market of rooster comb extract as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2013) 8319)

3.12.2013   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 322/39
            
         COMMISSION IMPLEMENTING DECISION
   of 29 November 2013
   authorising the placing on the market of rooster comb extract as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
   (notified under document C(2013) 8319)
   (Only the Spanish text is authentic)
   (2013/705/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 8 February 2011 the company Bioiberica S.A. made a request to the competent authorities of the United Kingdom to place rooster comb extract on the market as a novel food ingredient.
            
         
               (2)
            
            
               On 25 October 2011 the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that rooster comb extract for use in certain foods at the levels proposed by the applicant meets the criteria set out in Article 3(1) of Regulation (EC) No 258/97.
            
         
               (3)
            
            
               On 10 November 2011 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 second subparagraph of Article 6(4) of Regulation (EC) No 258/97. In particular, questions concerning the specifications and possible allergenicity of the product were raised.
            
         
               (5)
            
            
               On 22 May 2012 the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for rooster comb extract as food ingredient in accordance with Regulation (EC) No 258/97.
            
         
               (6)
            
            
               On 31 May 2013 the Authority adopted a Scientific Opinion on the rooster comb extract (2), concluding that it is safe under the proposed uses and use levels.
            
         
               (7)
            
            
               The Scientific Opinion gives sufficient grounds to establish that rooster comb extract in the proposed uses and use levels complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.
            
         
               (8)
            
            
               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
   Rooster comb extract as defined and specified in Annex I may be placed on the market as a novel food ingredient for the uses defined and at the maximum levels established in Annex II.
   Article 2
   The designation of rooster comb extract, authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘rooster comb extract’ or ‘cockerel comb extract’.
   Article 3
   This Decision is addressed to Bioiberica S.A., Plaça Francesc Macià, 7. 8B, 08029 Barcelona Spain.
   
      Done at Brussels, 29 November 2013.
      
         
            For the Commission
         
         Tonio BORG
         
            Member of the Commission
         
      
   
   
      (1)  OJ L 43, 14.2.1997, p. 1.
   
      (2)  EFSA Journal 2013; 11(6):3260.
   
      ANNEX I
      
         SPECIFICATION OF ROOSTER COMB EXTRACT
      
      
         Definition
      
      Rooster comb extract is obtained from Gallus gallus by enzymatic hydrolysis of rooster comb and by subsequent filtration, concentration and precipitation steps. The principal constituents of rooster comb extract are the glycosaminoglycans hyaluronic acid, chondroitin sulphate A and dermatan sulphate (chondroitin sulphate B).
      
                  Hyaluronic acid
               
               
                  60-80 %
               
            
                  Chondroitin sulphate A
               
               
                  Not more than 5 %
               
            
                  Dermatan sulphate (chondroitin sulphate B)
               
               
                  Not more than 25 %
               
            
         Description
      
      White or almost white hygroscopic powder.
      
         Identification
      
      
                  pH
               
               
                  5,0-8,5
               
            
         Purity
      
      
                  Chlorides
               
               
                  Not more than 1 %
               
            
                  Nitrogen
               
               
                  Not more than 8 %
               
            
                  Loss on drying (105 °C for 6 hours)
               
               
                  Not more than 10 %
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Chromium
               
               
                  Not more than 10 mg/kg
               
            
                  Lead
               
               
                  Not more than 0,5 mg/kg
               
            
         Microbiological criteria
      
      
                  Total viable aerobic count
               
               
                  Not more than 102 cfu/g
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 1 g
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 1 g
               
            
                  
                     Staphylococcus aureus
                  
               
               
                  Absent in 1 g
               
            
                  
                     Pseudomonas aeruginosa
                  
               
               
                  Absent in 1 g
               
            
   
      ANNEX II
      
         Authorised uses of rooster comb extract
      
      
                  Food category
               
               
                  Maximum use level (mg/100 g or mg/100 ml)
               
            
                  Milk-based drinks
               
               
                  40
               
            
                  Milk based fermented drinks
               
               
                  80
               
            
                  Yoghurt-type products
               
               
                  65
               
            
                  
                     Fromage frais
                  
               
               
                  110