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

26.11.2011 | EN | Official Journal of the European Union | L 313/41 ---|---|---|--- * * * COMMISSION IMPLEMENTING DECISION 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 (notified under document C(2011) 8527) (Only the English text is authentic) (2011/762/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 23 September 2009 the company Biothera Incorporated made a request to the competent authority of Ireland to place yeast beta-glucans on the market as a novel food ingredient for use in a variety of foods, including beverages, for the general population as well as in food supplements and in foods for particular nutritional uses with the exception of infant formulae and follow-on formulae. ---|--- (2) | On 23 December 2009 the competent food assessment body of Ireland issued its initial assessment report. In that report it came to the conclusion that yeast beta-glucans were acceptable as a novel food ingredient provided that the product specifications and intended use levels are maintained and that the range of foodstuffs is limited to those presented in the application dossier. ---|--- (3) | The Commission forwarded the initial assessment report to all Member States on 18 January 2010. ---|--- (4) | Within the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections to the marketing of the product were raised in accordance with that provision. ---|--- (5) | Therefore, the European Food Safety Authority (EFSA) was consulted on 2 July 2010. ---|--- (6) | On 8 April 2011, EFSA in the ‘Scientific Opinion on the safety of “Yeast beta-glucans” as a novel food ingredient’ (2) came to the conclusion that yeast beta-glucans were safe under the proposed conditions of use. EFSA opinion did not address in its opinion the safety for children below 1½ years. ---|--- (7) | On the basis of the EFSA scientific assessment and taking into account 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 (3), 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 (4), Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (5), Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (6), Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (7), it is established that yeast beta-glucans comply 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 Yeast (Saccharomyces cerevisiae) beta-glucans as specified in Annex I may be placed on the market in the Union as a novel food ingredient for the uses defined and at the maximum levels established in Annex II, and without prejudice to the provisions of Directive 2002/46/EC, Regulation (EC) No 1925/2006 and Directive 2009/39/EC. Article 2 The designation of yeast (Saccharomyces cerevisiae) beta-glucans authorised by this Decision for the labelling of the foodstuffs containing it shall be ‘yeast (Saccharomyces cerevisiae) beta-glucans’. Article 3 This Decision is addressed to Biothera Incorporated, 3388 Mike Collins Drive, Eagan, Minnesota, USA, 55121. Done at Brussels, 24 November 2011. For the Commission John DALLI Member of the Commission * * * (1) OJ L 43, 14.2.1997, p. 1. (2) EFSA Journal 2011; 9(5):2137 [22 pp.]. (3) OJ L 183, 12.7.2002, p. 51. (4) OJ L 404, 30.12.2006, p. 26. (5) OJ L 124, 20.5.2009, p. 21. (6) OJ L 91, 7.4.1999, p. 29. (7) OJ L 339, 6.12.2006, p. 16. * * * 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)-ß-D-glucans. This novel food is available both in an insoluble and soluble form, isolated from Saccharomyces cerevisiae. The insoluble products contain at least 70 % carbohydrate in the form of beta-glucans; the soluble product contains at least 75 % beta-glucans. The tertiary structure of the glucan cell wall of Saccharomyces cerevisiae consists of chains of ß-1,3-linked glucose residues, branched by ß-1,6-linkages, forming a backbone to which are linked chitin via ß-1,4- bonds, ß-1,6-glucans and some mannoproteins. Chemical characteristics yeast (Saccharomyces cerevisiae) beta-glucans --- | Soluble form | Insoluble form Total carbohydrate | More than 75 % | More than 70 % Beta-glucans (1,3/1,6) | More than 75 % | More than 70 % Ash | less than 4 % | Less than 5 % Moisture | Less than 8 % | Less than 8 % Protein | less than 3,5 % | Less than 10 % Fat | Less than 10 % | Less than 20 % * * * ANNEX II Food category | Use level ---|--- Food supplements, as defined in Directive 2002/46/EC | 375 mg (per day as recommended by the manufacturer) Foods for particular nutritional uses (Parnuts), as defined in Directive 2009/39/EC excluding infant and follow on formula | 600 mg (per day as recommended by the manufacturer) Beverages based on fruit juices | 130 mg/100 ml Fruit-flavoured drinks | 80 mg/100 ml Other beverages | 80 mg/100 ml (RTD) 700 mg/100 g (powder) Cereal bars | 600 mg/100 g Cookie-type biscuits | 670 mg/100 g Cracker-type biscuits | 20 mg/100 g Breakfast cereals | 670 mg/100 g Wholegrain and high fibre instant hot breakfast cereals | 150 mg/100 g Products based on yoghurt, fresh cheese and other dairy desserts | 160 mg/100 g Soups and soup mixes | 90 mg/100 g (RTE) 180 mg/100 g (condensed) 630 mg/100 g (powder) Chocolate and confectionery | 400 mg/100 g Protein bars and powders | 600 mg/100 g Abbreviations: RTD = ready to drink; RTE = ready to eat. * * *