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Document 32010R0009

    Commission Regulation (EU) No 9/2010 of 23 December 2009 concerning the authorisation of the endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) as a feed additive for chickens for fattening, laying hens, ducks and turkeys for fattening (holder of authorisation Danisco Animal Nutrition, Finnfeeds International Limited) Text with EEA relevance

    OJ L 3, 7.1.2010, p. 10–11 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    ⏵This document has been published in a special edition(s) (HR)

    Legal status of the document In force: This act has been changed. Current consolidated version: 30/03/2019

    ELI: http://data.europa.eu/eli/reg/2010/9/oj

    Date of document:
    23/12/2009
    Date of effect:
    27/01/2010; Entry into force Date pub. + 20 See Art 2
    Date of end of validity:
    No end date
    Author:
    European Commission
    Form:
    Regulation
    Additional information:
    EEA relevance
    Treaty:
    Treaty on the Functioning of the European Union
    Legal basis:
    Link
    Link
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    Modified by:
    Relation Act Comment Subdivision concerned From To
    Modified by 32012R1196 Replacement annex 03/01/2013
    Modified by 32019R0221 Replacement annex table column 2 Text 30/03/2019
    Modified by 32019R0221 Replacement title Text 30/03/2019
    Link

    7.1.2010   

    EN

    Official Journal of the European Union

    L 3/10

    COMMISSION REGULATION (EU) No 9/2010

    of 23 December 2009

    concerning the authorisation of the endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) as a feed additive for chickens for fattening, laying hens, ducks and turkeys for fattening (holder of authorisation Danisco Animal Nutrition, Finnfeeds International Limited)

    (Text with EEA relevance)

    THE EUROPEAN COMMISSION,

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

    Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

    Whereas:

    (1)

    Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

    (2)

    In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

    (3)

    The application concerns the authorisation of the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) as a feed additive for chickens for fattening, laying hens, ducks and turkeys for fattening, to be classified in the additive category ‘zootechnical additives’.

    (4)

    The European Food Safety Authority (the Authority) concluded in its opinions of 12 and 19 September 2007 (2), of 22 November 2007 (3) and of 2 July 2009 (4) that the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) does not have an adverse effect on animal health, human health or the environment and that the use of that preparation improves the performance of the animals. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003.

    (5)

    The assessment of that preparation shows that the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation.

    (6)

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

    HAS ADOPTED THIS REGULATION:

    Article 1

    The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

    Article 2

    This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

    This Regulation shall be binding in its entirety and directly applicable in all Member States.

    Done at Brussels, 23 December 2009.

    For the Commission

    The President

    José Manuel BARROSO

    (1)   OJ L 268, 18.10.2003, p. 29.

    (2)   The EFSA Journal (2007) 548, p. 1.

    (3)   The EFSA Journal (2007) 586, p. 1.

    (4)   The EFSA Journal (2009) 1183, p. 1.

    ANNEX

    Identification number of the additive

    Name of the holder of authorisation

    Additive

    Composition, chemical formula, description, analytical method

    Species or category of animal

    Maximum age

    Minimum content

    Maximum content

    Other provisions

    End of period of authorisation

    Units of activity/kg of complete feedingstuff with a moisture content of 12 %

    Category of zootechnical additives. Functional group: digestibility enhancers

    4a11

    Danisco Animal Nutrition, legal entity Finnfeeds International Limited

    Endo-1,4-β-xylanase

    EC 3.2.1.8

    Additive composition

    Preparation of endo-1,4-β-xylanase (EC 3.2.1.8) produced by Trichoderma reesei

    (ATCC PTA 5588) with a minimum activity of 40 000 U (1)/g

    Characterisation of the active substance

    Endo-1,4-β-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (ATCC PTA 5588)

    Chickens for fattening

    —

    625 U

    —

    1.

    In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

    2.

    For use in feed rich in starch and non starch polysaccharides (mainly arabinoxylans), e.g. containing more than 40 % wheat or 60 % maize.

    13.1.2020

    Laying hens

    2 500 U

    Ducks

    625 U

    Turkeys for fattening

    1 250 U

    (1)  1 U is the amount of enzyme which liberates 0,5 μmol of reducing sugar (expressed as xylose equivalents) from a cross-linked oat spelt arabinoxylan substrate at pH 5,3 and 50 °C in one minute.

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