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) and Article 13(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 and modifying such authorisation.
(2)
In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for a new use of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 and for an amendment of the terms of the current authorisation for chickens for fattening granted by Commission Implementing Regulation (EU) No 544/2013 (2). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003, and by the relevant data to support that amendment request.
(3)
The application concerns the authorisation of a new use of the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens reared for laying and minor poultry species other than laying, to be classified in the additive category ‘zootechnical additives’, the authorisation of a new use of that preparation via water for drinking for chickens for fattening and the modification of the terms of the current authorisation for chickens for fattening to allow simultaneous use with the additional coccidiostats: decoquinate, narasin, nicarbazin or narasin/nicarbazin, and to remove the limit for the maximum content of that preparation in complete feedingstuff.
(4)
The use of that preparation was authorised for 10 years for chickens for fattening by Commission Regulation (EU) No 544/2013.
(5)
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 9 December 2014 (3) that, under the proposed conditions of use, the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 does not have an adverse effect on animal health, human health and the environment and has the potential to be efficacious when used in chickens reared for laying and minor poultry species other than laying. The Authority also concluded that delivery of the additive via water for drinking is as safe for chickens for fattening as delivery via feed and that there would be no safety implications if the current maximum dose for chickens for fattening were withdrawn. The conclusions on safety for chickens for fattening, as regards delivery via water for drinking and maximum dose, would also apply to chickens reared for laying and minor avian species. The Authority further concluded that the additive is compatible with the coccidiostats decoquinate, narasin, nicarbazin or narasin/nicarbazin. 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.
(6)
The assessment of the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 shows that the conditions for authorisation, as 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.
(7)
In order to allow for the use of coccidiostats compatible with the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 also for chickens for fattening and to allow for the same content of that preparation in complete feedingstuff for chickens for fattening as for chickens reared for laying and minor poultry species it is appropriate to amend Regulation (EU) No 544/2013.
(8)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
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
The Annex to Regulation (EU) No 544/2013 is amended as follows:
(1)
In the eighth column, ‘Maximum content’, the text ‘1 × 109’ is deleted.
(2)
In the ninth column, ‘Other provisions’, paragraph 2 is replaced by the following:
‘2.
The use is permitted in feed containing the authorised coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin.’
Article 3
This Regulation shall enter into force on the twentieth day following that of 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, 8 July 2015.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 268, 18.10.2003, p. 29.
(2) Commission Implementing Regulation (EU) No 544/2013 of 14 June 2013 concerning the authorisation of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens for fattening (holder of authorisation Biomin GmbH) (OJ L 163, 15.6.2013, p. 13).
(3) EFSA Journal 2015; 13(1):3966.
ANNEX
PART A
PART A
|
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
|
Minimum content
|
Maximum content
|
Other provisions
|
End of period of authorisation
|
|
CFU (1)/kg of complete feedingstuff with a moisture content of 12 %
|
CFU (1) l of water for drinking
|
|
Category of zootechnical additives. Functional group: gut flora stabilisers.
|
|
4b1890
|
Biomin GmbH
|
Bifidobacterium animalis ssp.animalisDSM 16284,Lactobacillus salivarius ssp.salivariusDSM 16351 andEnterococcus faeciumDSM 21913
|
Additive composition
Preparation ofBifidobacterium animalis ssp.animalisDSM 16284 containing a minimum of 3 × 109 CFU/g additive
Lactobacillus salivarius ssp.salivariusDSM 16351 containing a minimum of 1 × 109 CFU/g additive
Enterococcus faeciumDSM 21913 containing a minimum of 6 × 109 CFU/g additive
Solid preparation (ratio 3:1:6)
Characterisation of the active substance
Viable cells ofBifidobacterium animalis ssp.animalisDSM 16284,Lactobacillus salivarius ssp.salivariusDSM 16351, andEnterococcus faeciumDSM 21913
Analytical method (2)
For the enumeration of:Bifidobacterium animalis ssp.animalisDSM 16284: spread plate method EN 15785Lactobacillus salivarius ssp.salivariusDSM 16351: spread plate method EN 15787Enterococcus faeciumDSM 21913 spread plate method EN 15788 For the identification: Pulsed Field Gel Electrophoresis (PFGE)
|
Chickens reared for laying, minor poultry species other than laying
|
|
1 × 108
|
—
|
5 × 107
|
—
|
|
1.
|
In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
|
|
2.
|
The use is permitted in feed containing the following coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin.
|
|
3.
|
For safety: breathing protection, glasses and gloves shall be used during handling.
|
|
4.
|
The additive may be used also via water for drinking.
|
|
5.
|
For use of the additive in water for drinking the homogeneous dispersion of the additive shall be ensured.
|
|
6.
|
The simultaneous use with antibiotic shall be avoided.
|
|
29 July 2025
|
PART B
|
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 (3)/l of water for drinking
|
|
|
|
4b1890
|
Biomin GmbH
|
Bifidobacterium animalis ssp.animalisDSM 16284,Lactobacillus salivarius ssp.salivariusDSM 16351 andEnterococcus faeciumDSM 21913
|
Additive composition
Preparation ofBifidobacterium animalis ssp.animalisDSM 16284 containing a minimum of 3 × 109 CFU/g additive
Lactobacillus salivarius ssp.salivariusDSM 16351 containing a minimum of 1 × 109 CFU/g additive
Enterococcus faeciumDSM 21913 containing a minimum of 6 × 109 CFU/g additive
Solid preparation (ratio 3:1:6)
Characterisation of the active substance
Viable cells ofBifidobacterium animalis ssp.animalisDSM 16284,Lactobacillus salivarius ssp.salivariusDSM 16351, andEnterococcus faeciumDSM 21913
Analytical method (4)
For the enumeration of:Bifidobacterium animalis ssp.animalisDSM 16284: spread plate method EN 15785Lactobacillus salivarius ssp.salivariusDSM 16351: spread plate method EN 15787Enterococcus faeciumDSM 21913 spread plate method EN 15788 For the identification: Pulsed Field Gel Electrophoresis (PFGE)
|
Chickens for fattening
|
—
|
5 × 107
|
—
|
|
1.
|
In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
|
|
2.
|
The water for drinking containing the additive may be used simultaneously with feed containing the following permitted coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin.
|
|
3.
|
For safety: breathing protection, glasses and gloves shall be used during handling.
|
|
4.
|
The homogeneous dispersion of the additive shall be ensured in the water for drinking.
|
|
5.
|
The simultaneous use with antibiotic shall be avoided.
|
|
29 July 2025
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