
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.
ANNEX I
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 gAbbreviations: RTD = ready to drink; RTE = ready to eat.