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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)

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)

Regulation (EC) No 258/97 · Decision · 5 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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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.

Article 2

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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’.

Article 3

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This Decision is addressed to Biothera Incorporated, 3388 Mike Collins Drive, Eagan, Minnesota, USA, 55121.

Supplementary provisions

ANNEX ISupplementary provisions

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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

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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.

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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