LegalizeCommission 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)
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.
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 | Chemical data |
| (1,3)-(1,6)-β-D-Glucan | > 80 % |
| Ash | < 2 % |
| Moisture | < 6 % |
| Protein | < 4 % |
| Total fat | < 3 % |
| Microbiological data | 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 | Heavy metals |
| Lead | < 0,2 mg/kg |
| Arsenic | < 0,2 mg/kg |
| Mercury | < 0,1 mg/kg |
| Cadmium | < 0,1 mg/kg |
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 |
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