
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
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)-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.


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

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 population0,675 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