# L_2016152EN.01000701.xml

| 9.6.2016 | EN | Official Journal of the European Union | L 152/7 |
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9.6.2016

EN

Official Journal of the European Union

L 152/7

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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

(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) and Article 13(3) 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 the authorisation of a preparation of Bacillus subtilis (C-3102). 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 the authorisation of a preparation of Bacillus subtilis (C-3102). Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | Those applications concern the authorisation of a preparation of Bacillus subtilis (C-3102) as a feed additive for all laying birds and ornamental fish to be classified in the additive category ‘zootechnical additives’. |
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(3)

Those applications concern the authorisation of a preparation of Bacillus subtilis (C-3102) as a feed additive for all laying birds and ornamental fish to be classified in the additive category ‘zootechnical additives’.

| (4) | That preparation was already authorised as a feed additive for use in chickens for fattening by Commission Regulation (EC) No 1444/2006 (2) in piglets by Commission Regulation (EU) No 333/2010 (3), and in chickens reared for laying and turkeys, minor avian species and other ornamental and game birds by Commission Regulation (EU) No 184/2011 (4). |
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(4)

That preparation was already authorised as a feed additive for use in chickens for fattening by Commission Regulation (EC) No 1444/2006 (2) in piglets by Commission Regulation (EU) No 333/2010 (3), and in chickens reared for laying and turkeys, minor avian species and other ornamental and game birds by Commission Regulation (EU) No 184/2011 (4).

| (5) | The European Food Safety Authority (‘the Authority’) concluded in its opinions of 28 September 2015 (5) and of 11 November 2015 (6) that, under the proposed conditions of use, the preparation of Bacillus subtilis (C-3102) is presumed not to have an adverse effect on animal health, human health or the environment. It concluded that, under the proposed condition of use, the additive has the potential to be efficacious in reducing the amount of feed per unit of mass egg production over the entire laying period. The Authority also concluded that the additive has the potential to improve the grow and feed utilisation in ornamental fish. It 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 28 September 2015 (5) and of 11 November 2015 (6) that, under the proposed conditions of use, the preparation of Bacillus subtilis (C-3102) is presumed not to have an adverse effect on animal health, human health or the environment. It concluded that, under the proposed condition of use, the additive has the potential to be efficacious in reducing the amount of feed per unit of mass egg production over the entire laying period. The Authority also concluded that the additive has the potential to improve the grow and feed utilisation in ornamental fish. It 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) 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) 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 applicant has also submitted an application in accordance with Article 13(3) of Regulation (EC) No 1831/2003 proposing to change the name of the holder of the authorisation and the name of its representative in the EU in Regulations (EC) No 1444/2006, (EU) No 333/2010 and (EU) No 184/2011. The applicant claims that, with effect from 1 January 2016, it has changed its name from ‘Calpis Co. Ltd’ to ‘Asahi Calpis Wellness Co. Ltd’. The name of its representative in the EU has changed from ‘Calpis Co. Ltd Europe Representative Office’ to ‘Asahi Calpis Wellness Co. Ltd Europe Representative Office’. The applicant has submitted relevant data supporting its request. |
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(7)

The applicant has also submitted an application in accordance with Article 13(3) of Regulation (EC) No 1831/2003 proposing to change the name of the holder of the authorisation and the name of its representative in the EU in Regulations (EC) No 1444/2006, (EU) No 333/2010 and (EU) No 184/2011. The applicant claims that, with effect from 1 January 2016, it has changed its name from ‘Calpis Co. Ltd’ to ‘Asahi Calpis Wellness Co. Ltd’. The name of its representative in the EU has changed from ‘Calpis Co. Ltd Europe Representative Office’ to ‘Asahi Calpis Wellness Co. Ltd Europe Representative Office’. The applicant has submitted relevant data supporting its request.

| (8) | In order to enable Asahi Calpis Wellness Co. Ltd to exploit its marketing rights it is necessary to change the terms of the authorisations. |
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(8)

In order to enable Asahi Calpis Wellness Co. Ltd to exploit its marketing rights it is necessary to change the terms of the authorisations.

| (9) | Regulations (EC) No 1444/2006, (EU) No 333/2010 and (EU) No 184/2011 should therefore be amended accordingly. |
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(9)

Regulations (EC) No 1444/2006, (EU) No 333/2010 and (EU) No 184/2011 should therefore be amended accordingly.

| (10) | 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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(10)

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

In the Annex to Regulation (EC) No 1444/2006, in the second column, name of the holder of authorisation, the term ‘Calpis Co., Ltd represented in the Community by Orffa International Holding BV’ is replaced by the term ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’.

Article 3

Regulation (EU) No 333/2010 is amended as follows:

| (a) | in the title, the term ‘holder of authorisation Calpis Co. Ltd Japan, represented in the European Union by Calpis Co. Ltd Europe Representative Office’ is replaced by the term ‘holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’; |
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(a)

in the title, the term ‘holder of authorisation Calpis Co. Ltd Japan, represented in the European Union by Calpis Co. Ltd Europe Representative Office’ is replaced by the term ‘holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’;

| (b) | in the Annex, in the second column, name of the holder of authorisation, the term ‘Calpis Co. Ltd Japan, represented in the European Union by Calpis Co. Ltd Europe Representative Office, France’ is replaced by the term ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’. |
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(b)

in the Annex, in the second column, name of the holder of authorisation, the term ‘Calpis Co. Ltd Japan, represented in the European Union by Calpis Co. Ltd Europe Representative Office, France’ is replaced by the term ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’.

Article 4

Regulation (EU) No 184/2011 is amended as follows:

| (a) | in the title, the term ‘holder of authorisation Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative Office’ is replaced by the term ‘holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’; |
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(a)

in the title, the term ‘holder of authorisation Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative Office’ is replaced by the term ‘holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’;

| (b) | in the Annex, in the second column, name of the holder of authorisation, the term ‘Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative Office, France’ is replaced by the term ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’. |
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(b)

in the Annex, in the second column, name of the holder of authorisation, the term ‘Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative Office, France’ is replaced by the term ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’.

Article 5

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 June 2016.

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

Bacillus subtilis

(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

Bacillus subtilis

(5)  EFSA Journal 2015; 13(9):4231.

5

(6)  EFSA Journal 2015; 13(11):4274.

6

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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 in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office | Bacillus subtilis C-3102 (DSM 15544) | Additive composition


  Bacillus subtilis C-3102 (DSM 15544) with minimum of 1,0 × 1010 CFU/g

  Characterisation of the active substance

  Viable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544)

  Analytical method
   (1)

  Enumeration: spread plate method using tryptone soya agar in all target matrices (EN 15784:2009)
  Identification: pulsed-field gel electrophoresis (PFGE). | Laying hens | — | 3 × 108 | — | 1. | In the directions for use of the additive, premixture and compound feedingstuff indicate the storage temperature, storage life and stability to pelleting 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 in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office

Bacillus subtilis C-3102 (DSM 15544)

Additive composition

Bacillus subtilis C-3102 (DSM 15544) with minimum of 1,0 × 1010 CFU/g

Characterisation of the active substance

Viable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544)

Analytical method
   (1)

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

Identification: pulsed-field gel electrophoresis (PFGE).

Laying hens

—

3 × 108

—

1.

In the directions for use of the additive, premixture and compound feedingstuff indicate the storage temperature, storage life and stability to pelleting shall be indicated.

| 2. | For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalator or eyes exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment. |
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2.

For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalator or eyes exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

29 June 2026

Ornamental fish

1 × 1010

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(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: www.irmm.jrc.ec.europa.eu/crl-feed-additives

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