# L_2017326EN.01004701.xml

| 9.12.2017 | EN | Official Journal of the European Union | L 326/47 |
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9.12.2017

EN

Official Journal of the European Union

L 326/47

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/2275

of 8 December 2017

concerning the authorisation of a new use of the preparation of Lactobacillus acidophilus (CECT 4529) as a feed additive for chickens for fattening (holder of the authorisation Centro Sperimentale del Latte)

(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 a new use of the preparation of Lactobacillus acidophilus (CECT 4529). 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 a new use of the preparation of Lactobacillus acidophilus (CECT 4529). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of a new use of the preparation of Lactobacillus acidophilus (CECT 4529) as a feed additive for chickens for fattening to be classified in the additive category ‘zootechnical additives’. |
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(3)

The application concerns the authorisation of a new use of the preparation of Lactobacillus acidophilus (CECT 4529) as a feed additive for chickens for fattening to be classified in the additive category ‘zootechnical additives’.

| (4) | The preparation of Lactobacillus acidophilus (CECT 4529) belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for laying hens by Commission Implementing Regulation (EU) 2015/38 (2). |
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(4)

The preparation of Lactobacillus acidophilus (CECT 4529) belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for laying hens by Commission Implementing Regulation (EU) 2015/38 (2).

| (5) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 21 March 2017 (3) that, under the proposed conditions of use, the preparation of Lactobacillus acidophilus (CECT 4529) 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 weight gain/final weight only in two of three studies assessed. Two other studies were excluded due to the unusually high mortality and low growing performance of birds. 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 opinion of 21 March 2017 (3) that, under the proposed conditions of use, the preparation of Lactobacillus acidophilus (CECT 4529) 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 weight gain/final weight only in two of three studies assessed. Two other studies were excluded due to the unusually high mortality and low growing performance of birds. 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) | However these evidences have been judged as a sufficient indication of the improvement of zootechnical parameters of weight gain. Therefore it was considered that the provided data meet the conditions for the demonstration of the efficacy of the additive for chickens for fattening. |
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(6)

However these evidences have been judged as a sufficient indication of the improvement of zootechnical parameters of weight gain. Therefore it was considered that the provided data meet the conditions for the demonstration of the efficacy of the additive for chickens for fattening.

| (7) | The assessment of the preparation of Lactobacillus acidophilus (CECT 4529) 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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(7)

The assessment of the preparation of Lactobacillus acidophilus (CECT 4529) 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.

| (8) | 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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(8)

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 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 Implementing Regulation (EU) 2015/38 of 13 January 2015 concerning the authorisation of the preparation of Lactobacillus acidophilus CECT 4529 as a feed additive for laying hens and amending Regulation (EC) No 1520/2007 (holder of authorisation Centro Sperimentale del Latte) (OJ L 8, 14.1.2015, p. 4).

2

(3)  
  EFSA Journal 2017; 15(4):4762.

3

EFSA Journal 2017

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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 |
| 4b1715 | Centro Sperimentale del latte | Lactobacillus acidophilus CECT 4529 | Additive composition:

  Preparation of Lactobacillus acidophilus CECT 4529 containing a minimum of: 5 × 1010 CFU/g of additive (solid form).

  Characterisation of the active substance:

  Viable cells of Lactobacillus acidophilus CECT 4529.

  Analytical method
   (1)

  Enumeration: spread plate method using MRS agar (EN 15787).
  Identification: Pulsed Field Gel Electrophoresis (PFGE). | Chickens for fattening | — | 1 × 109 | — | 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

4b1715

Centro Sperimentale del latte

Lactobacillus acidophilus CECT 4529

Additive composition:

Preparation of Lactobacillus acidophilus CECT 4529 containing a minimum of: 5 × 1010 CFU/g of additive (solid form).

Characterisation of the active substance:

Viable cells of Lactobacillus acidophilus CECT 4529.

Analytical method
   (1)

Enumeration: spread plate method using MRS agar (EN 15787).

Identification: Pulsed Field Gel Electrophoresis (PFGE).

Chickens for fattening

—

1 × 109

—

1.

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

| 2. | 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 eyes, skin and breathing protection. |
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2.

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 eyes, skin and breathing protection.

29.12.2027

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(1)  Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

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