Commission Implementing Regulation (EU) 2015/1053 of 1 July 2015 concerning the authorisation of the preparation of Enterococcus faecium DSM 10663/NCIMB 10415 as a feed additive for calves for rearing, piglets, chickens for fattening, turkeys for fattening, cats and dogs and amending Regulations (EC) No 1259/2004, (EC) No 255/2005, (EC) No 1200/2005 and (EC) No 1520/2007 (holder of authorisation Chevita Tierarzneimittel-GmbH) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2015/1053
• Articles: 8

Article 1 Authorisation

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

Article 2 Amendments to Regulation (EC) No 1259/2004

Regulation (EC) No 1259/2004 is amended as follows:

(1)

Article 1 is deleted.

(2)

Annex I is deleted.

Article 3 Amendment to Regulation (EC) No 255/2005

In Annex I to Regulation (EC) No 255/2005, the entry on E 1707, Enterococcus faecium DSM 10663/NCIMB 10415, is deleted.

Article 4 Amendment to Regulation (EC) No 1200/2005

In Annex II to Regulation (EC) No 1200/2005, the entry on E 1707, Enterococcus faecium DSM 10663/NCIMB 10415, is deleted.

Article 5 Amendments to Regulation (EC) No 1520/2007

Regulation (EC) No 1520/2007 is amended as follows:

(1)

Articles 2 and 3 are deleted.

(2)

Annexes II and III are deleted.

Article 6 Transitional measures

(1)   The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 22 January 2016 in accordance with the rules applicable before 22 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for calves, piglets, chickens for fattening and turkeys for fattening.

(2)   The preparation specified in the Annex and feed containing that preparation, which are produced and labelled [for dogs] before 22 July 2017 in accordance with the rules applicable before 22 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for dogs.

Article 7 Entry into force

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

Schedules & Appendices

ANNEX

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

CFU/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers.

4b1707

Chevita Tierarzneimittel-GmbH

Enterococcus faecium

DSM 10663/NCIMB 10415

Additive composition

Preparation of Enterococcus faecium

DSM 10663/NCIMB 10415 containing a minimum of:

powder and granulated forms:

3,5 × 10 10 CFU/g additive;

coated form:

2 × 10 10 CFU/g additive;

liquid form:

1 × 10 10 CFU/g additive

Characterisation of the active substance

Viable cells of Enterococcus faecium

DSM 10663/NCIMB 10415

Analytical method

( 1 )

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

Identification: Pulsed- Field Gel Electrophoresis (PFGE)

Calves for rearing

Piglets

(suckling and weaned)

Chickens for fattening

Turkeys for fattening

Cats

Dogs

—

1 × 10 9

—

1.

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

2.

Recommended dose for suckling piglets: 1 × 10 9 /piglet/day.

3.

The use is permitted in feed for chickens for fattening and turkeys for fattening containing the authorised coccidiostats: semduramicin sodium, diclazuril, robenidine hydrochloride, maduramicin ammonium, decoquinate, lasalocid A sodium or halofuginone.

4.

For use in weaned piglets until approximately 35 kg.

22 July 2025

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports