# L_2017331EN.01004101.xml

| 14.12.2017 | EN | Official Journal of the European Union | L 331/41 |
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14.12.2017

EN

Official Journal of the European Union

L 331/41

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/2312

of 13 December 2017

concerning the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office)

(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, applications were submitted for a new use of the preparation Bacillus subtilis C-3102 (DSM 15544). Those applications were 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, applications were submitted for a new use of the preparation Bacillus subtilis C-3102 (DSM 15544). Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The applications concern the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs to be classified in the additive category ‘zootechnical additives’. |
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(3)

The applications concern the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs to be classified in the additive category ‘zootechnical additives’.

| (4) | The preparation of Bacillus subtilis C-3102 (DSM 15544), belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for chickens for fattening by Commission Regulation (EC) No 1444/2006 (2); for weaned piglets by Commission Regulation (EU) No 333/2010 (3); for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds by Commission Regulation (EU) No 184/2011 (4), and for laying hens and ornamental fish by Commission Implementing Regulation (EU) 2016/897 (5). |
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(4)

The preparation of Bacillus subtilis C-3102 (DSM 15544), belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for chickens for fattening by Commission Regulation (EC) No 1444/2006 (2); for weaned piglets by Commission Regulation (EU) No 333/2010 (3); for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds by Commission Regulation (EU) No 184/2011 (4), and for laying hens and ornamental fish by Commission Implementing Regulation (EU) 2016/897 (5).

| (5) | The European Food Safety Authority (‘the Authority’) concluded in its opinions of 21 March 2017 (6) that, under the proposed conditions of use, the preparation of Bacillus subtilis C-3102 (DSM 15544) does not have an adverse effect on animal health, human health and the environment. It also concluded that the additive has the potential to improve the zootechnical performance parameters of sows and suckling piglets and to increase the faecal dry matter in dogs. 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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(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 21 March 2017 (6) that, under the proposed conditions of use, the preparation of Bacillus subtilis C-3102 (DSM 15544) does not have an adverse effect on animal health, human health and the environment. It also concluded that the additive has the potential to improve the zootechnical performance parameters of sows and suckling piglets and to increase the faecal dry matter in dogs. 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 Bacillus subtilis C-3102 (DSM 15544) 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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(6)

The assessment of the preparation of Bacillus subtilis C-3102 (DSM 15544) 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) | 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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(7)

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, 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)  Commission Regulation (EC) No 1444/2006 of 29 September 2006 concerning the authorisation of Bacillus subtilis C-3102 (Calsporin) as a feed additive (OJ L 271, 30.9.2006, p. 19).

2

Bacillus subtilis

(3)  Commission Regulation (EU) No 333/2010 of 22 April 2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Calpis Co. Ltd Japan, represented in the European Union by Calpis Co. Ltd Europe Representative Office (OJ L 102, 23.4.2010, p. 19).

3

(4)  Commission Regulation (EU) No 184/2011 of 25 February 2011 concerning the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds (holder of authorisation Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative Office) (OJ L 53, 26.2.2011, p. 33).

4

(5)  Commission Implementing Regulation (EU) 2016/897 of 8 June 2016 concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 15544) as a feed additive for laying hens and ornamental fish (holder of authorisation Asahi Calpis Wellness Co. Ltd) and amending Regulations (EC) No 1444/2006, (EU) No 333/2010 and (EU) No 184/2011 as regards the holder of the authorisation (OJ L 152, 9.6.2016, p. 7).

5

(6)  
  EFSA Journal 2017; 15(4):4760 and EFSA Journal 2017; 15(4):4761.

6

EFSA Journal

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 |
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| CFU/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: gut flora stabilisers |
| 4b1820 | Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office | Bacillus subtilis

  DSM 15544 | Additive composition

  Preparation of Bacillus subtilis C-3102
  DSM 15544 containing a minimum of 1 × 1010 CFU/g additive in solid form

  Characterisation of the active substance

  Viable cells of Bacillus subtilis
  DSM 15544

  Analytical method

  Enumeration: spread plate method using tryptone soya agar in all target matrices (EN 15784:2009)
  Identification: pulsed-field gel electrophoresis (PFGE). | Sows
  Suckling piglets | — | 3 × 108 | — | 1. | In the directions for use of the additive and premixture, the storage conditions and 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

4b1820

Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office

Bacillus subtilis

DSM 15544

Additive composition

Preparation of Bacillus subtilis C-3102

DSM 15544 containing a minimum of 1 × 1010 CFU/g additive in solid form

Characterisation of the active substance

Viable cells of Bacillus subtilis

DSM 15544

Analytical method

Enumeration: spread plate method using tryptone soya agar in all target matrices (EN 15784:2009)

Identification: pulsed-field gel electrophoresis (PFGE).

Sows

Suckling piglets

—

3 × 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.

| 2. | Indicate in the instruction for the use:
  ‘The additive shall be fed to lactating sows and suckling piglets simultaneously’ |
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2.

Indicate in the instruction for the use:

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

| 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 breathing protection. |
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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 breathing protection.

3 January 2028

Dogs

1 × 109

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