Commission 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)

• CELEX: Implementing Decision (EU) 2017/2078
• Articles: 5

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.

Schedules & Appendices

ANNEX I

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

(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

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