CELEX: 32017D2078
Language: en
Date: 2017-11-10 00:00:00
Title: Commission Implementing Decision (EU) 2017/2078 of 10 November 2017 authorising an extension of use of yeast beta-glucans as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2017) 7391)

14.11.2017   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 295/77
               
            COMMISSION IMPLEMENTING DECISION (EU) 2017/2078
      of 10 November 2017
      authorising an extension of use of yeast beta-glucans as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
      
         
            (notified under document C(2017) 7391)
         
      
      (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)
               
               
                  Commission Implementing Decision 2011/762/EU (2) authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of yeast beta-glucans as a novel food ingredient to be used in certain foods and foodstuffs, including beverages, as well as in food supplements and in food for special medical purposes, and total diet replacement for weight control.
               
            
                  (2)
               
               
                  On 25 April 2016, the company Leiber GmbH made a request to the competent authority of Ireland for extension of uses and use levels of yeast beta-glucans as a novel food ingredient. In particular, they asked to extend the use of yeast beta-glucans to additional food categories and to increase maximum use levels of yeast beta-glucans per day for food categories already authorised by Implementing Decision 2011/762/EU.
               
            
                  (3)
               
               
                  On 7 November 2016, the competent authority of Ireland issued its initial assessment report. In that report, it came to the conclusion that the extension of uses and proposed maximum use levels of yeast beta-glucans meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.
               
            
                  (4)
               
               
                  On 15 November 2016, the Commission forwarded the initial assessment report to the other Member States.
               
            
                  (5)
               
               
                  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. The applicant consequently modified the request concerning the food categories and use levels proposed. That change and additional explanations by the applicant alleviated the concerns to the satisfaction of the Member States and the Commission.
               
            
                  (6)
               
               
                  Directive 2002/46/EC of the European Parliament and of the Council (3) lays down requirements for food supplements. Regulation (EC) No 1925/2006 of the European Parliament and of the Council (4) lays down requirements on the addition of vitamins and minerals and certain other substances to foods. Regulation (EU) No 609/2013 of the European Parliament and of the Council (5) lays down general compositional and information requirements on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control. Those acts may apply to the yeast beta-glucans. Therefore yeast beta-glucans should be authorised without prejudice to the requirements of that and of any other legislation applying in parallel to Regulation (EC) No 258/97.
               
            
                  (7)
               
               
                  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 the provisions of Directive 2002/46/EC, Regulation (EC) No 1925/2006 and Regulation (EU) No 609/2013, yeast (Saccharomyces cerevisiae) beta-glucans as specified in Annex I to this Decision may be placed on the Union market as a novel food ingredient for the uses defined and at the maximum levels established in Annex II to this Decision.
      Article 2
      The designation of yeast (Saccharomyces cerevisiae) beta-glucans authorised by this Decision on the labelling of the foodstuffs shall be ‘yeast (Saccharomyces cerevisiae) beta-glucans’.
      Article 3
      This Decision is addressed to Leiber GmbH, Hafenstraße 24, 49565 Bramsche, Germany.
      
         Done at Brussels, 10 November 2017.
         
            
               For the Commission
            
            Vytenis ANDRIUKAITIS
            
               Member of the Commission
            
         
      
      
         (1)  OJ L 43, 14.2.1997, p. 1.
      
         (2)  Commission Implementing Decision 2011/762/EU of 24 November 2011 authorising the placing on the market of yeast beta-glucans as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 313, 26.11.2011, p. 41).
      
         (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).
      
         (4)  Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26).
      
         (5)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC, and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 12.6.2013, p. 35).
      
         ANNEX I
         
            SPECIFICATIONS OF YEAST (SACCHAROMYCES CEREVISIAE) BETA-GLUCANS
         
         
            Description
         
         Beta-glucans are complex, high molecular mass (100–200 kDa) polysaccharides, found in the cell wall of many yeasts and cereals. The chemical name for ‘yeast beta-glucans’ is (1-3), (1-6)-β-D-glucans.
         Beta-glucans consist of a backbone of β-1-3-linked glucose residues that are branched by β-1-6-linkages, to which chitin and mannoproteins are linked by β-1-4-bonds.
         This novel food is a highly purified (1,3)-(1,6)-β-D-glucan isolated from yeast Saccharomyces cerevisiae, insoluble in water, but dispersible in many liquid matrices.
         
            Specifications of yeast (Saccharomyces cerevisiae) beta-glucans
         
         
                     Parameter
                  
                  
                     Specifications values
                  
               
                     
                        Solubility
                     
                  
                  
                     
                        Insoluble in water but dispersible in many liquid matrices
                     
                  
               
                     Chemical data
                  
               
                     (1,3)-(1,6)-β-D-Glucan
                  
                  
                     > 80 %
                  
               
                     Ash
                  
                  
                     < 2 %
                  
               
                     Moisture
                  
                  
                     < 6 %
                  
               
                     Protein
                  
                  
                     < 4 %
                  
               
                     Total fat
                  
                  
                     < 3 %
                  
               
                     Microbiological data
                  
               
                     Total plate count
                  
                  
                     < 1 000  CFU/g
                  
               
                     Enterobacteriaceae
                  
                  
                     < 100 CFU/g
                  
               
                     Total coliforms
                  
                  
                     < 10 CFU/g
                  
               
                     Yeast
                  
                  
                     < 25 CFU/g
                  
               
                     Mould
                  
                  
                     < 25 CFU/g
                  
               
                     
                        Salmonella ssp.
                  
                  
                     Absent in 25 g
                  
               
                     
                        Escherichia coli
                     
                  
                  
                     Absent in 1 g
                  
               
                     
                        Bacillus cereus
                     
                  
                  
                     < 100 CFU/g
                  
               
                     
                        Staphylococcus aureus
                     
                  
                  
                     Absent in 1 g
                  
               
                     Heavy metals
                  
               
                     Lead
                  
                  
                     < 0,2 mg/g
                  
               
                     Arsenic
                  
                  
                     < 0,2 mg/g
                  
               
                     Mercury
                  
                  
                     < 0,1 mg/g
                  
               
                     Cadmium
                  
                  
                     < 0,1 mg/g
                  
               
      
         ANNEX II
         
            AUTHORISED USES OF YEAST (SACCHAROMYCES CEREVISIAE) BETA-GLUCANS
         
         
                     Food category
                  
                  
                     Maximum level of yeast beta-glucans
                  
               
                     Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children
                  
                  
                     1,275 g/day for children older than 12 years and general adult population
                     0,675 g/day for children younger than 12 years
                  
               
                     Total diet replacement for weight control as defined in Regulation (EU) No 609/2013
                  
                  
                     1,275 g/day
                  
               
                     Food for special medical purposes as defined in Regulation (EU) No 609/2013, excluding food for special medical purposes intended for infants and young children
                  
                  
                     1,275 g/day
                  
               
                     Beverages based on fruit and/or vegetable juices including concentrate and dehydrated juices
                  
                  
                     1,3 g/kg
                  
               
                     Fruit-flavoured drinks
                  
                  
                     0,8 g/kg
                  
               
                     Cocoa beverages preparation powder
                  
                  
                     38,3 g/kg (powder)
                  
               
                     Cereal bars
                  
                  
                     6 g/kg
                  
               
                     Breakfast cereals
                  
                  
                     15,3 g/kg
                  
               
                     Wholegrain and high fibre instant hot breakfast cereals
                  
                  
                     1,5 g/kg
                  
               
                     Cookie-type biscuits
                  
                  
                     2,2 g/kg
                  
               
                     Cracker-type biscuits
                  
                  
                     6,7 g/kg
                  
               
                     Milk based beverages
                  
                  
                     3,8 g/kg
                  
               
                     Fermented milk products
                  
                  
                     3,8 g/kg
                  
               
                     Milk product analogues
                  
                  
                     3,8 g/kg
                  
               
                     Other beverages
                  
                  
                     0,8 g/kg (ready to drink)
                  
               
                     Dried milk/milk powder
                  
                  
                     25,5 g/kg
                  
               
                     Soup and soup mixes
                  
                  
                     0,9 g/kg (ready to eat)
                     1,8 g/kg (condensed)
                     6,3 g/kg (powder)
                  
               
                     Chocolate and confectionary
                  
                  
                     4 g/kg
                  
               
                     Protein bars and powder
                  
                  
                     19,1 g/kg
                  
               
                     Jam, marmalade and other fruit spreads
                  
                  
                     11,3 g/kg