02017D2078 — EN — 19.08.2019 — 001.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
|
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) (OJ L 295 14.11.2017, p. 77) |
Amended by:
|
|
|
Official Journal |
||
|
No |
page |
date |
||
|
COMMISSION IMPLEMENTING REGULATION (EU) 2019/1272 of 29 July 2019 |
L 201 |
3 |
30.7.2019 |
|
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
|
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/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 |