Commission Implementing Regulation (EU) No 1061/2013Show full title

Commission Implementing Regulation (EU) No 1061/2013 of 29 October 2013 concerning the authorisation of a preparation of Enterococcus faecium NCIMB 10415 as a feed additive for calves, kids, cats and dogs and amending Regulation (EC) No 1288/2004 (holder of the authorisation DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o) (Text with EEA relevance)

ANNEXU.K.

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Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %
Category of zootechnical additives. Functional group: gut flora stabilisers
4b1705DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o

Enterococcus faecium

NCIMB 10415

  • Additive composition

    Preparation of Enterococcus faecium

    NCIMB 10415 containing a minimum of: microencapsulated form with shellac and other microencapsulated forms:

    1 × 1010 CFU/g additive;

    non-coated granulated forms:

    3,5 × 1010 CFU/g additive

  • Characterisation of the active substance

    Viable cells of Enterococcus faecium

    NCIMB 10415

  • Analytical method a

    Enumeration: spread plate method using bile esculin azide agar (EN 15788)

    Identification: Pulsed-Field Gel Electrophoresis (PFGE)

Calves

Kids

—1 × 109—In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.19 November 2023
4b1705DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o

Enterococcus faecium

NCIMB 10415

  • Additive composition

    Preparation of Enterococcus faecium

    NCIMB 10415 containing a minimum of: 5 × 109 CFU/g of additive;

    Microencapsulated forms (shellac).

  • Characterisation of the active substance

    Viable cells of Enterococcus faecium

    NCIMB 10415

  • Analytical method a

    Enumeration: spread plate method using bile esculin azide agar (EN 15788)

    Identification: Pulsed-Field Gel Electrophoresis (PFGE)

Cats—7 × 109—In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.19 November 2023
Category of zootechnical additives. Functional group: other zootechnical additives (improvement of gut conditions)
4b1705DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o

Enterococcus faecium

NCIMB 10415

  • Additive composition

    Preparation of Enterococcus faecium

    NCIMB 10415 containing a minimum of 5 × 109 CFU/g of additive.

    Microencapsulated forms (shellac).

  • Characterisation of the active substance

    Viable cells of Enterococcus faecium

    NCIMB 10415

  • Analytical method a

    Enumeration: spread plate method using bile esculin azide agar (EN 15788)

    Identification: Pulsed-Field Gel Electrophoresis (PFGE)

Dogs—2,5 × 109In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.19 November 2023