Document ID: 02017D2078-20190819
Language: ENG

02017D2078 — EN — 19.08.2019 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING DECISION (EU) 2017/2078</p><p>of 10 November 2017</p><p>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</p><p><span><span>(notified under document C(2017) 7391)</span></span></p><p><a>(Only the English text is authentic)</a></p><p>(OJ L 295 14.11.2017, p. 77)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p>&#160;</p></td><td><p>&#160;</p></td><td><p>Official Journal</p></td></tr><tr><td><p>&#160;&#160;No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>&#9658;M1</a></p></td><td><p><a>                              COMMISSION IMPLEMENTING REGULATION (EU) 2019/1272&#160;of 29&#160;July 2019</a></p></td><td><p>&#160;&#160;L&#160;201</p></td><td><p>3</p></td><td><p>30.7.2019</p></td></tr></table>
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)
(Only the English text is authentic)
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
<table><col/><col/><tbody><tr><td><p>Parameter</p></td><td><p>Specifications values</p></td></tr><tr><td><p><span>Solubility</span></p></td><td><p><span>Insoluble in water but dispersible in many liquid matrices</span></p></td></tr><tr><td><p>Chemical data</p></td></tr><tr><td><p>(1,3)-(1,6)-&#946;-D-Glucan</p></td><td><p>&gt;&#160;80&#160;%</p></td></tr><tr><td><p>Ash</p></td><td><p>&lt;&#160;2&#160;%</p></td></tr><tr><td><p>Moisture</p></td><td><p>&lt;&#160;6&#160;%</p></td></tr><tr><td><p>Protein</p></td><td><p>&lt;&#160;4&#160;%</p></td></tr><tr><td><p>Total fat</p></td><td><p>&lt;&#160;3&#160;%</p></td></tr><tr><td><p>Microbiological data</p></td></tr><tr><td><p>Total plate count</p></td><td><p>&lt;&#160;1&#160;000  CFU/g</p></td></tr><tr><td><p>Enterobacteriaceae</p></td><td><p>&lt;&#160;100 CFU/g</p></td></tr><tr><td><p>Total coliforms</p></td><td><p>&lt;&#160;10 CFU/g</p></td></tr><tr><td><p>Yeast</p></td><td><p>&lt;&#160;25 CFU/g</p></td></tr><tr><td><p>Mould</p></td><td><p>&lt;&#160;25 CFU/g</p></td></tr><tr><td><p><span>Salmonella</span> ssp.</p></td><td><p>Absent in 25&#160;g</p></td></tr><tr><td><p><span>Escherichia coli</span></p></td><td><p>Absent in 1&#160;g</p></td></tr><tr><td><p><span>Bacillus cereus</span></p></td><td><p>&lt;&#160;100 CFU/g</p></td></tr><tr><td><p><span>Staphylococcus aureus</span></p></td><td><p>Absent in 1&#160;g</p></td></tr><tr><td><p>Heavy metals</p></td></tr><tr><td><p><a>&#9660;M1</a></p></td></tr><tr><td><p>Lead</p></td><td><p>&lt; 0,2&#160;mg/kg</p></td></tr><tr><td><p>Arsenic</p></td><td><p>&lt; 0,2&#160;mg/kg</p></td></tr><tr><td><p>Mercury</p></td><td><p>&lt; 0,1&#160;mg/kg</p></td></tr><tr><td><p>Cadmium</p></td><td><p>&lt; 0,1&#160;mg/kg</p></td></tr><tr><td><p><a>&#9660;B</a></p></td></tr></tbody></table>
ANNEX II
AUTHORISED USES OF YEAST ( SACCHAROMYCES CEREVISIAE ) BETA-GLUCANS
<table><col/><col/><tbody><tr><td><p>Food category</p></td><td><p>Maximum level of yeast beta-glucans</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children</p></td><td><p>1,275&#160;g/day for children older than 12 years and general adult population</p><p>0,675&#160;g/day for children younger than 12 years</p></td></tr><tr><td><p>Total diet replacement for weight control as defined in Regulation (EU) No 609/2013</p></td><td><p>1,275&#160;g/day</p></td></tr><tr><td><p>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</p></td><td><p>1,275&#160;g/day</p></td></tr><tr><td><p>Beverages based on fruit and/or vegetable juices including concentrate and dehydrated juices</p></td><td><p>1,3&#160;g/kg</p></td></tr><tr><td><p>Fruit-flavoured drinks</p></td><td><p>0,8&#160;g/kg</p></td></tr><tr><td><p>Cocoa beverages preparation powder</p></td><td><p>38,3&#160;g/kg (powder)</p></td></tr><tr><td><p>Cereal bars</p></td><td><p>6&#160;g/kg</p></td></tr><tr><td><p>Breakfast cereals</p></td><td><p>15,3&#160;g/kg</p></td></tr><tr><td><p>Wholegrain and high fibre instant hot breakfast cereals</p></td><td><p>1,5&#160;g/kg</p></td></tr><tr><td><p>Cookie-type biscuits</p></td><td><p>2,2&#160;g/kg</p></td></tr><tr><td><p>Cracker-type biscuits</p></td><td><p>6,7&#160;g/kg</p></td></tr><tr><td><p>Milk based beverages</p></td><td><p>3,8&#160;g/kg</p></td></tr><tr><td><p>Fermented milk products</p></td><td><p>3,8&#160;g/kg</p></td></tr><tr><td><p>Milk product analogues</p></td><td><p>3,8&#160;g/kg</p></td></tr><tr><td><p>Other beverages</p></td><td><p>0,8&#160;g/kg (ready to drink)</p></td></tr><tr><td><p>Dried milk/milk powder</p></td><td><p>25,5&#160;g/kg</p></td></tr><tr><td><p>Soup and soup mixes</p></td><td><p>0,9&#160;g/kg (ready to eat)</p><p>1,8&#160;g/kg (condensed)</p><p>6,3&#160;g/kg (powder)</p></td></tr><tr><td><p>Chocolate and confectionary</p></td><td><p>4&#160;g/kg</p></td></tr><tr><td><p>Protein bars and powder</p></td><td><p>19,1&#160;g/kg</p></td></tr><tr><td><p>Jam, marmalade and other fruit spreads</p></td><td><p>11,3&#160;g/kg</p></td></tr></tbody></table>