# L_2017269EN.01002701.xml

| 19.10.2017 | EN | Official Journal of the European Union | L 269/27 |
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19.10.2017

EN

Official Journal of the European Union

L 269/27

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1904

of 18 October 2017

concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for chickens for fattening and chickens reared for laying (holder of authorisation Huvepharma NV)

(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. |
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(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 a preparation of Bacillus licheniformis DSM 28710. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of Bacillus licheniformis DSM 28710. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | That application concerns the authorisation of the preparation of Bacillus licheniformis DSM 28710 as a feed additive for chickens for fattening and chickens reared for laying, to be classified in the additive category ‘zootechnical additives’. |
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(3)

That application concerns the authorisation of the preparation of Bacillus licheniformis DSM 28710 as a feed additive for chickens for fattening and chickens reared for laying, to be classified in the additive category ‘zootechnical additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 18 October 2016 (2) that, under the proposed conditions of use, the preparation of Bacillus licheniformis DSM 28710 does not have an adverse effect on animal health, human health or the environment, and that it has a potential to improve the feed to gain ratio of chickens for fattening and that this conclusion can be extended to chickens reared for laying. 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. |
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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 18 October 2016 (2) that, under the proposed conditions of use, the preparation of Bacillus licheniformis DSM 28710 does not have an adverse effect on animal health, human health or the environment, and that it has a potential to improve the feed to gain ratio of chickens for fattening and that this conclusion can be extended to chickens reared for laying. 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 Bacillus licheniformis DSM 28710 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. |
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(5)

The assessment of the preparation of Bacillus licheniformis DSM 28710 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.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(6)

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

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, 18 October 2017.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  
  EFSA Journal 2016;14(11):4615.

2

EFSA Journal

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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 |
| 4b1828 | Huvepharma NV | Bacillus licheniformis DSM 28710 | Additive composition

  Preparation of Bacillus licheniformis DSM 28710
  containing a minimum of 3,2 × 109 CFU/g of additive.
  Solid form

  Characterisation of the active substance

  Viable spores of Bacillus licheniformis DSM 28710

  Analytical method
   (1)

  For the enumeration of Bacillus licheniformis DSM 28710 in additive, premixture and feedingstuffs:
  Spread plate method EN 15784
  For the identification Bacillus licheniformis DSM 28710: Identification: Pulsed Field Gel Electrophoresis (PFGE) | Chickens for fattening
  Chickens reared for laying | — | 1,6 × 109 | — | 1. | In the directions for use of the additive and premixtures, the storage conditionsand stability to heat treatment shall be indicated. |

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

4b1828

Huvepharma NV

Bacillus licheniformis DSM 28710

Additive composition

Preparation of Bacillus licheniformis DSM 28710

containing a minimum of 3,2 × 109 CFU/g of additive.

Solid form

Characterisation of the active substance

Viable spores of Bacillus licheniformis DSM 28710

Analytical method
   (1)

For the enumeration of Bacillus licheniformis DSM 28710 in additive, premixture and feedingstuffs:

Spread plate method EN 15784

For the identification Bacillus licheniformis DSM 28710: Identification: Pulsed Field Gel Electrophoresis (PFGE)

Chickens for fattening

Chickens reared for laying

—

1,6 × 109

—

1.

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

| 2. | The use is permitted in feed containing the following authorised coccidiostats: decoquinate, diclazuril, halofuginone, nicarbazin, robenidine hydrochloride, lasalocid A sodium, maduramicin ammonium, monensin sodium, narasin, or salinomycin sodium. |
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2.

The use is permitted in feed containing the following authorised coccidiostats: decoquinate, diclazuril, halofuginone, nicarbazin, robenidine hydrochloride, lasalocid A sodium, maduramicin ammonium, monensin sodium, narasin, or salinomycin sodium.

| 3. | 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 including skin and eyes protections. |
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3.

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 including skin and eyes protections.

8 November 2027

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(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

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