# L_2011313EN.01004101.xml

| 26.11.2011 | EN | Official Journal of the European Union | L 313/41 |
| --- | --- | --- | --- |

26.11.2011

EN

Official Journal of the European Union

L 313/41

---

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)

(Only the English text is authentic)

(2011/762/EU)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (1), and in particular Article 7 thereof,

Whereas:

| (1) | On 23 September 2009 the company Biothera Incorporated made a request to the competent authority of Ireland to place yeast beta-glucans on the market as a novel food ingredient for use in a variety of foods, including beverages, for the general population as well as in food supplements and in foods for particular nutritional uses with the exception of infant formulae and follow-on formulae. |
| --- | --- |

(1)

On 23 September 2009 the company Biothera Incorporated made a request to the competent authority of Ireland to place yeast beta-glucans on the market as a novel food ingredient for use in a variety of foods, including beverages, for the general population as well as in food supplements and in foods for particular nutritional uses with the exception of infant formulae and follow-on formulae.

| (2) | On 23 December 2009 the competent food assessment body of Ireland issued its initial assessment report. In that report it came to the conclusion that yeast beta-glucans were acceptable as a novel food ingredient provided that the product specifications and intended use levels are maintained and that the range of foodstuffs is limited to those presented in the application dossier. |
| --- | --- |

(2)

On 23 December 2009 the competent food assessment body of Ireland issued its initial assessment report. In that report it came to the conclusion that yeast beta-glucans were acceptable as a novel food ingredient provided that the product specifications and intended use levels are maintained and that the range of foodstuffs is limited to those presented in the application dossier.

| (3) | The Commission forwarded the initial assessment report to all Member States on 18 January 2010. |
| --- | --- |

(3)

The Commission forwarded the initial assessment report to all Member States on 18 January 2010.

| (4) | Within the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections to the marketing of the product were raised in accordance with that provision. |
| --- | --- |

(4)

Within the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections to the marketing of the product were raised in accordance with that provision.

| (5) | Therefore, the European Food Safety Authority (EFSA) was consulted on 2 July 2010. |
| --- | --- |

(5)

Therefore, the European Food Safety Authority (EFSA) was consulted on 2 July 2010.

| (6) | On 8 April 2011, EFSA in the ‘Scientific Opinion on the safety of “Yeast beta-glucans” as a novel food ingredient’ (2) came to the conclusion that yeast beta-glucans were safe under the proposed conditions of use. EFSA opinion did not address in its opinion the safety for children below 11⁄2 years. |
| --- | --- |

(6)

On 8 April 2011, EFSA in the ‘Scientific Opinion on the safety of “Yeast beta-glucans” as a novel food ingredient’ (2) came to the conclusion that yeast beta-glucans were safe under the proposed conditions of use. EFSA opinion did not address in its opinion the safety for children below 11⁄2 years.

| (7) | On the basis of the EFSA scientific assessment and taking into account Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (3), Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (4), Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (5), Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (6), Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (7), it is established that yeast beta-glucans comply with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97. |
| --- | --- |

(7)

On the basis of the EFSA scientific assessment and taking into account Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (3), Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (4), Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (5), Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (6), Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (7), it is established that yeast beta-glucans comply with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

| (8) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(8)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

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.

Done at Brussels, 24 November 2011.

For the Commission

John DALLI

Member of the Commission

---

(1)  
  OJ L 43, 14.2.1997, p. 1.

1

(2)  
  EFSA Journal 2011; 9(5):2137 [22 pp.].

2

EFSA Journal

(3)  
  OJ L 183, 12.7.2002, p. 51.

3

(4)  
  OJ L 404, 30.12.2006, p. 26.

4

(5)  
  OJ L 124, 20.5.2009, p. 21.

5

(6)  
  OJ L 91, 7.4.1999, p. 29.

6

(7)  
  OJ L 339, 6.12.2006, p. 16.

7

---

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 % |

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

| 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 |

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.

---