2011/73/EU: Commission Decision of 2 February 2011 authorising the placing on the... (32011D0073)
    EU - Rechtsakte: 13 Industrial policy and internal market

    COMMISSION DECISION

    of 2 February 2011

    authorising the placing on the market of a mycelial extract from

    Lentinula edodes

    (Shiitake mushroom) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

    (notified under document C(2011) 442)

    (Only the English text is authentic)

    (2011/73/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 19 December 2007 the company GlycaNova Norge AS made a request to the competent authorities of the United Kingdom to place a mycelial extract from the Shiitake mushroom (
    Lentinula edodes
    formerly
    Lentinus edodes
    ) on the market as a novel food ingredient.
    (2) On 3 November 2008 the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that the use of the mycelial extract from
    Lentinula edodes
    as a food ingredient was acceptable.
    (3) The Commission forwarded the initial assessment report to all Member States on 7 January 2009.
    (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 24 September 2009.
    (6) On 9 July 2010, EFSA (Panel on Dietetic Products, Nutrition and Allergies) in the ‘Scientific opinion on the safety of “
    Lentinula edodes
    extract” as a novel food ingredient’(2) came to the conclusion that the mycelial extract from
    Lentinula edodes
    was safe under the proposed conditions of use and the proposed levels of intake.
    (7) On the basis of the scientific assessment, it is established that mycelial extract from
    Lentinula edodes
    complies 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,
    HAS ADOPTED THIS DECISION:

    Article 1

    The mycelial extract from
    Lentinula edodes
    as specified in Annex I may be placed on the market in the Union as a novel food ingredient for the uses listed in Annex II.

    Article 2

    The designation of the mycelial extract from
    Lentinula edodes
    authorised by this Decision on the labelling of the foodstuff containing it shall be ‘extract from the mushroom
    Lentinula edodes
    ’ or ‘extract from the Shiitake mushroom’.

    Article 3

    This Decision is addressed to GlycaNova Norge AS, Oraveien 2, 1630 Gamle Fredrikstad, Norway.
    Done at Brussels, 2 February 2011.
    For the Commission
    John DALLI
    Member of the Commission
    (1)  
    OJ L 43, 14.2.1997, p. 1
    .
    (2)  EFSA Journal 2010; 8(7): 1685.

    ANNEX I

    Specifications of the mycelial extract from

    Lentinula edodes

    Description:

    The novel food ingredient is a sterile aqueous extract obtained from the mycelium of
    Lentinula edodes
    cultivated in a submerged fermentation. It is a light brown, slightly turbid liquid.
    Lentinan is a β-(1-3) β-(1-6)-D-glucan which has a molecular weight of approximately 5 × 10
    5
    Daltons, a degree of branching of 2/5 and a triple helical tertiary structure.

    Composition of the mycelial extract from Lentinula edodes

    Moisture

    98 %

    Dry matter

    2 %

    Free glucose

    less than 20 mg/ml

    Total Protein(1)

    less than 0,1 mg/ml

    N-containing constituents(2)

    less than 10 mg/ml

    Lentinan

    0,8 – 1,2 mg/ml

    (1)  Bradford method
    (2)  Kjeldahl method

    ANNEX II

    Uses of the mycelial extract from
    Lentinula edodes

    Use group

    Maximum level of mycelial extract from Lentinula edodes

    Bread products

    2 ml/100 g

    Soft drinks

    0,5 ml/100 ml

    Ready prepared meals

    2,5 ml per meal

    Foods based on yoghurt

    1,5 ml/100 ml

    Food supplements (as defined in Directive 2002/46/EC(1))

    2,5 ml per day dose

    (1)  
    OJ L 183, 12.7.2002, p. 51
    .
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