# L_2017331EN.01001901.xml

| 14.12.2017 | EN | Official Journal of the European Union | L 331/19 |
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14.12.2017

EN

Official Journal of the European Union

L 331/19

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/2308

of 13 December 2017

concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for suckling piglets (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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). |
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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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

| (2) | The preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive, for pigs for fattening and piglets by Commission Regulation (EC) No 2148/2004 (3). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. That preparation was authorised for 10 years for weaned piglets, pigs for fattening, sows, calves for rearing and turkeys for fattening by Commission Implementing Regulation (EU) 2017/447 (4). |
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(2)

The preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive, for pigs for fattening and piglets by Commission Regulation (EC) No 2148/2004 (3). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. That preparation was authorised for 10 years for weaned piglets, pigs for fattening, sows, calves for rearing and turkeys for fattening by Commission Implementing Regulation (EU) 2017/447 (4).

| (3) | In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for piglets. The application was also for the assessment of this preparation for a new use in water for drinking. The applicant requested that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for piglets. The application was also for the assessment of this preparation for a new use in water for drinking. The applicant requested that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 July 2016 (5) that, under the proposed conditions of use, the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) does not have an adverse effect on animal health, human health or the environment. The Authority considered that the additive has the potential to improve weight gain in suckling piglets when used in feed or in water for drinking. 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 12 July 2016 (5) that, under the proposed conditions of use, the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) does not have an adverse effect on animal health, human health or the environment. The Authority considered that the additive has the potential to improve weight gain in suckling piglets when used in feed or in water for drinking. 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 5750) and Bacillus licheniformis (DSM 5749) 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 5750) and Bacillus licheniformis (DSM 5749) 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

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

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.

Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 13 December 2017.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  Commission Regulation (EC) No 2148/2004 of 16 December 2004 concerning the permanent and provisional authorisations of certain additives and the authorisation of new uses of an additive already authorised in feedingstuffs (OJ L 370, 17.12.2004, p. 24).

3

(4)  Commission Implementing Regulation (EU) 2017/447 of 14 March 2017 concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for sows, weaned piglets, pigs for fattening, calves for rearing and turkeys for fattening and amending Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 600/2005 (holder of authorisation Chr. Hansen A/S) (OJ L 69, 15.3.2017, p. 19).

4

Bacillus subtilis

Bacillus licheniformis

(5)  
  EFSA Journal 2016; 14(9):4558.

5

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 | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| CFU/kg of complete feedingstuff with a moisture content of 12 % | CFU/l of water for drinking |
| Category of zootechnical additives. Functional group: gut flora stabilisers |
| 4b1700i | Chr.Hansen A/S | Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) | Additive composition

  Preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) containing a minimum of 3,2 × 1010 CFU/g of additive
  (1:1 ratio)
  Solid form

  Characterisation of the active substance

  Viable spores of Bacillus subtilis

  (DSM 5750) and Bacillus licheniformis (DSM 5749)

  Analytical method
   (1)

  Identification and enumeration of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) in the feed additive, premixtures, feedingstuffs and water:






  — | 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

Minimum content

Maximum content

Other provisions

End of period of authorisation

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

CFU/l of water for drinking

Category of zootechnical additives. Functional group: gut flora stabilisers

4b1700i

Chr.Hansen A/S

Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749)

Additive composition

Preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) containing a minimum of 3,2 × 1010 CFU/g of additive

(1:1 ratio)

Solid form

Characterisation of the active substance

Viable spores of Bacillus subtilis

(DSM 5750) and Bacillus licheniformis (DSM 5749)

Analytical method
   (1)

Identification and enumeration of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) in the feed additive, premixtures, feedingstuffs and water:

—

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.

Suckling piglets

—

1,3 × 109

—

6,5 × 108

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

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

| 2. | The additive may be used in water for drinking. |
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2.

The additive may be used in water for drinking.

| 3. | For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured. |
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3.

For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.

| 4. | Indicate in the instructions for use:
  ‘The additive shall be fed to lactating sows and suckling piglets simultaneously’ |
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4.

Indicate in the instructions for use:

‘The additive shall be fed to lactating sows and suckling piglets simultaneously’

| 5. | 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 breathing protection and skin protection. |
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5.

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 breathing protection and skin protection.

3 January 2028

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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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