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Document 32012R0237

    Commission Implementing Regulation (EU) No 237/2012 of 19 March 2012 concerning the authorisation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) as a feed additive for chickens for fattening (holder of authorisation Kerry Ingredients and Flavours) Text with EEA relevance

    IO L 80, 20.3.2012, p. 1–3 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    ⏵Foilsíodh an doiciméad seo in eagrán speisialta (HR)

    Legal status of the document No longer in force, Date of end of validity: 25/03/2024; Arna aisghairm le 32024R0781

    ELI: http://data.europa.eu/eli/reg_impl/2012/237/oj

    20.3.2012   

    EN

    Official Journal of the European Union

    L 80/1

    COMMISSION IMPLEMENTING REGULATION (EU) No 237/2012

    of 19 March 2012

    concerning the authorisation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) as a feed additive for chickens for fattening (holder of authorisation Kerry Ingredients and Flavours)

    (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 alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604). 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 alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) as a feed additive for chickens for fattening, to be classified in the additive category ‘zootechnical additives’.

    (4)

    The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 November 2011 (2) that, under the proposed conditions of use, the preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) does not have an adverse effect on animal health, human health or the environment, and that its use can improve the final body weight in chickens for fattening. 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 Reference Laboratory set up by Regulation (EC) No 1831/2003.

    (5)

    The assessment of the preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this 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 twentieth 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, 19 March 2012.

    For the Commission

    The President

    José Manuel BARROSO

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

    (2)   EFSA Journal 2011; 9(12):2451.

    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

    4a17

    Kerry Ingredients and Flavours

    Alpha-galactosidase

    (EC 3.2.1.22)

    Endo-1,4-beta-glucanase

    (EC 3.2.1.4)

     

    Additive composition

    Preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604), solid form, with a minimum activity of:

    —

    1 000  U (1) alpha-galactosidase/g

    —

    5 700  U (2) endo-1,4-beta-glucanase/g

     

    Characterisation of the active substance

    Alpha-galactosidase produced by Saccharomyces cerevisiae (CBS 615.94) Endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 120604)

     

    Method of Analysis  (3)

    Determination:

    —

    colorimetric method measuring p-nitrophenol released by action of alpha-galactosidase from p-nitrophenyl-alpha-galactopyranoside substrate,

    —

    colorimetric method measuring water soluble dye released by action of endo-1,4-beta-glucanase from azurine-crosslinked barley glucan substrate.

    Chickens for fattening

    —

    50 U alpha-galactosidase

    285 U endo-1,4-beta-glucanase

    —

    1.

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

    2.

    Maximum recommended dose:

    —

    100 U alpha-galactosidase/kg

    —

    570 U endo-1,4-beta-glucanase/kg.

    3.

    For safety: breathing protection, glasses and gloves shall be used during handling.

    9 April 2022

    (1)  1 U is the amount of the enzyme which liberates 1 μmol of p-nitrolphenol per minute from p-nitrophenyl-alpha-galactopyranoside (pNPG) at pH 5,0 and 37 °C.

    (2)  1 U is the amount of the enzyme which liberates 1 mg of reducing sugar (glucose equivalent) per minute from beta-glucan at pH 5,0 and 50 °C.

    (3)  Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

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