# L_2017153EN.01001601.xml

| 16.6.2017 | EN | Official Journal of the European Union | L 153/16 |
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16.6.2017

EN

Official Journal of the European Union

L 153/16

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1008

of 15 June 2017

concerning the authorisation of the preparation of of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p as a feed additive for chickens for fattening (holder of authorisation JHJ Ltd)

(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 the preparation of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p. 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 the preparation of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p. 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 of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p as a feed additive for chickens for fattening, to be classified in the additive category ‘zootechnical additives’. |
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(3)

That application concerns the authorisation of the preparation of of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p as a feed additive for chickens for fattening, to be classified in the additive category ‘zootechnical additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 July 2016 (2) that, under the proposed conditions of use, the preparation of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p does not have an adverse effect on animal health, human health or the environment, and that it has a potential to improve zootechnical performance in chickens for fattening. 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 (2) that, under the proposed conditions of use, the preparation of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p does not have an adverse effect on animal health, human health or the environment, and that it has a potential to improve zootechnical performance in chickens for fattening. 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 of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p 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 of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p 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.

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, 15 June 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(9):4555.

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 |
| 4b1892 | JHJ Ltd | Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p | Additive composition

  Preparation of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p containing a minimum of 1,2 × 109 CFU/g of total Lactic Acid Bacteria (LAB) and Saccharomyces cerevisiae PCM KKP 2059p 1 × 107 CFU/g
  having a minimum of: | Lactococcus lactis PCM B/00039 ≥ 5 × 108 CFU/g |

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

4b1892

JHJ Ltd

Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p

Additive composition

Preparation of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p containing a minimum of 1,2 × 109 CFU/g of total Lactic Acid Bacteria (LAB) and Saccharomyces cerevisiae PCM KKP 2059p 1 × 107 CFU/g

having a minimum of:

Lactococcus lactis PCM B/00039 ≥ 5 × 108 CFU/g

| | Carnobacterium divergens PCM KKP 2012p ≥ 3 × 108 CFU/g |
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Carnobacterium divergens PCM KKP 2012p ≥ 3 × 108 CFU/g

| | Lactobacillus casei PCM B/00080 ≥ 1 × 108 CFU/g |
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Lactobacillus casei PCM B/00080 ≥ 1 × 108 CFU/g

| | Lactobacillus plantarum PCM B/00081 ≥ 3 × 108 CFU/g |
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Lactobacillus plantarum PCM B/00081 ≥ 3 × 108 CFU/g

| | Saccharomyces cerevisiae PCM KKP 2059p ≥ 1 × 107 CFU/g |
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Saccharomyces cerevisiae PCM KKP 2059p ≥ 1 × 107 CFU/g

Characterisation of the active substance

Viable cells of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p

Analytical method
   (1)

For the enumeration of Lactococcus lactis PCM B/00039 and Carnobacterium divergens PCM KKP 2012p in the feed additive and feedingstuffs:

| — | Poured-plate method using de Man, Rogosa and Sharpe (MRS) agar ISO 15214 |
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—

Poured-plate method using de Man, Rogosa and Sharpe (MRS) agar ISO 15214

For the enumeration of Lactobacilli in the feed additive and feedingstuffs:

| — | Poured-plate method using MRS agar EN 15787 |
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—

Poured-plate method using MRS agar EN 15787

For the enumeration of Saccharomyces cerevisiae PCM KKP 2059p in the feed additive and feedingstuffs:

| — | Poured-plate method using chloramphenicol glucose yeast extract (CGYE) agar EN 15789 |
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Poured-plate method using chloramphenicol glucose yeast extract (CGYE) agar EN 15789

For the identification of Lactobacilli, Lactococcus lactis PCM B/00039 and Carnobacterium divergens PCM KKP 2012p:

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

Identification: Pulsed-Field Gel Electrophoresis (PFGE)

For the identification of Saccharomyces cerevisiae PCM KKP 2059p:

| — | Polymerase Chain Reaction (PCR) |
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—

Polymerase Chain Reaction (PCR)

Chickens for fattening

—

5 × 108 (LAB)

5 × 106 (Saccharomyces cerevisiae PCM KKP 2059p)

—

| 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. | The use is permitted in feed containing the following authorised coccidiostats: narasin/nicarbazin, salinomycin sodium, diclazuril, decoquinate, or maduramicin ammonium. |
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2.

The use is permitted in feed containing the following authorised coccidiostats: narasin/nicarbazin, salinomycin sodium, diclazuril, decoquinate, or maduramicin ammonium.

| 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 and skin 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 and skin protection.

6 July 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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