# L_2017034EN.01001801.xml

| 9.2.2017 | EN | Official Journal of the European Union | L 34/18 |
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9.2.2017

EN

Official Journal of the European Union

L 34/18

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/219

of 8 February 2017

concerning the authorisation of a preparation of Bacillus subtilis (DSM 27273) as a feed additive for weaned piglets and weaned minor porcine species (holder of authorisation Chr. Hansen A/S)

(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 subtilis (DSM 27273). 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 subtilis (DSM 27273). 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 a preparation of Bacillus subtilis (DSM 27273) as a feed additive for weaned piglets and weaned minor porcine species to be classified in the additive category ‘zootechnical additives’. |
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(3)

That application concerns the authorisation of a preparation of Bacillus subtilis (DSM 27273) as a feed additive for weaned piglets and weaned minor porcine species to be classified in the additive category ‘zootechnical additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 20 October 2015 (2) that, under the proposed conditions of use, the preparation of Bacillus subtilis (DSM 27273) does not have an adverse effect on animal health, human health or the environment. It was also concluded that the preparation has a potential to improve performance in weaned piglets. This conclusion can be extrapolated to weaned minor porcine species when the additive is used at the same dose. 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 20 October 2015 (2) that, under the proposed conditions of use, the preparation of Bacillus subtilis (DSM 27273) does not have an adverse effect on animal health, human health or the environment. It was also concluded that the preparation has a potential to improve performance in weaned piglets. This conclusion can be extrapolated to weaned minor porcine species when the additive is used at the same dose. 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 subtilis (DSM 27273) 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 subtilis (DSM 27273) 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, 8 February 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 2015;13(11):4269.

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/Units of active substance/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: gut flora stabilisers |
| 4b1826 | Chr.Hansen A/S | Bacillus subtilis
  DSM 27273 | Additive composition

  Preparation of Bacillus subtilis

  DSM 27273 containing a minimum of 1,6 × 109 CFU/g of additive
  Solid form

  Characterisation of the active substance

  Viable spores of Bacillus subtilis

  DSM 27273

  Analytical method
   (1)

  Identification and enumeration of Bacillus subtilis DSM 27273 in the feed additive, premixtures and feedingstuffs:






  — | Identification: Pulsed Field Gel Electrophoresis (PFGE) |

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/Units of active substance/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers

4b1826

Chr.Hansen A/S

Bacillus subtilis

DSM 27273

Additive composition

Preparation of Bacillus subtilis

DSM 27273 containing a minimum of 1,6 × 109 CFU/g of additive

Solid form

Characterisation of the active substance

Viable spores of Bacillus subtilis

DSM 27273

Analytical method
   (1)

Identification and enumeration of Bacillus subtilis DSM 27273 in the feed additive, premixtures and feedingstuffs:

—

Identification: Pulsed Field Gel Electrophoresis (PFGE)

| — | Enumeration: Spread plate method using tryptone soya agar — EN 15784 |
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Enumeration: Spread plate method using tryptone soya agar — EN 15784

Weaned piglets

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4 × 108

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| 1. | In the directions for use of the additive and premixtures, indicate the storage temperature, storage life and stability to pelleting. |
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1.

In the directions for use of the additive and premixtures, indicate the storage temperature, storage life and stability to pelleting.

| 2. | For use in weaned piglets up to 35 kg of body weight.
  For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its 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 breathing, eyes and skin protections. |
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2.

For use in weaned piglets up to 35 kg of body weight.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its 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 breathing, eyes and skin protections.

1 March 2027

Weaned minor porcine species

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4 × 108

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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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