Commission Implementing Regulation (EU) 2019/11Show full title

Commission Implementing Regulation (EU) 2019/11 of 3 January 2019 concerning the authorisation of the preparation of Enterococcus faecium NCIMB 10415 as a feed additive for sows, suckling piglets, weaned piglets, pigs for fattening, and amending Regulations (EC) No 252/2006, (EC) No 943/2005 and (EC) No 1200/2005 (holder of authorisation DSM Nutritional products Ltd, represented by DSM Nutritional Products Sp. z o.o.) (Text with EEA relevance)

ANNEX

a

Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

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:

  • coated form (with shellac):

    2 × 1010 CFU/g additive, or

  • other coated forms:

    1 × 1010 CFU/g additive, or

  • granulated non-coated form:

    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)

Sows—7 × 108—

1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2. The additive shall be administered to pregnant and lactating sows and simultaneously to the suckling piglets

3. For use in weaned piglets until approximately 35 kg.

4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment.

24 January 2029
Suckling piglets1 × 109—

Weaned piglets

Pigs for fattening

3,5 × 108—