2011/762/EU: 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)
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.
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’.
This Decision is addressed to Biothera Incorporated, 3388 Mike Collins Drive, Eagan, Minnesota, USA, 55121.
Supplementary provisions
ANNEX ISupplementary provisions
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 IISupplementary provisions
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.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.