Legalize2011/762/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)
Article 1
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
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
This Decision is addressed to Biothera Incorporated, 3388 Mike Collins Drive, Eagan, Minnesota, USA, 55121.
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 | Chemical characteristics yeast (Saccharomyces cerevisiae) beta-glucans | 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 II
USES OF PURE BETA-GLUCANS FROM YEAST (SACCHAROMYCES CEREVISIAE)
| 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.
OJ L 43, 14.2.1997, p. 1.
EFSA Journal 2011; 9(5):2137 [22 pp.].
OJ L 183, 12.7.2002, p. 51.
OJ L 404, 30.12.2006, p. 26.
OJ L 124, 20.5.2009, p. 21.
OJ L 91, 7.4.1999, p. 29.
OJ L 339, 6.12.2006, p. 16.
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.
This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence.
EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.