# L_2020324EN.01000301.xml

| 6.10.2020 | EN | Official Journal of the European Union | L 324/3 |
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6.10.2020

EN

Official Journal of the European Union

L 324/3

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1395

of 5 October 2020

concerning the renewal of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive for chickens for fattening, its authorisation for chickens reared for laying, and repealing Regulation (EC) No 1292/2008 (holder of authorisation Evonik Nutrition & Care GmbH)

(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 and renewing 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 and renewing such authorisation.

| (2) | Bacillus amyloliquefaciens CECT 5940 was authorised for 10 years as a feed additive for chickens for fattening by Commission Regulation (EC) No 1292/2008 (2). |
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(2)

Bacillus amyloliquefaciens CECT 5940 was authorised for 10 years as a feed additive for chickens for fattening by Commission Regulation (EC) No 1292/2008 (2).

| (3) | In accordance with Article 14 of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an application was submitted by the holder of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive for the renewal of the authorisation for chickens for fattening, and for a new authorisation for chickens reared for laying, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Articles 7(3) and 14(2) of that Regulation. |
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(3)

In accordance with Article 14 of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an application was submitted by the holder of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive for the renewal of the authorisation for chickens for fattening, and for a new authorisation for chickens reared for laying, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Articles 7(3) and 14(2) of that Regulation.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 January 2020 (3) that the applicant has provided data demonstrating that the additive complies with the conditions of authorisation. The Authority confirmed its previous conclusions that Bacillus amyloliquefaciens CECT 5940 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that it is not an irritant to skin/eye or a skin sensitiser but should be considered a potential respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards to users of the additive. The Authority also concluded that the additive has the potential to be efficacious in chickens reared for laying. |
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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 January 2020 (3) that the applicant has provided data demonstrating that the additive complies with the conditions of authorisation. The Authority confirmed its previous conclusions that Bacillus amyloliquefaciens CECT 5940 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that it is not an irritant to skin/eye or a skin sensitiser but should be considered a potential respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards to users of the additive. The Authority also concluded that the additive has the potential to be efficacious in chickens reared for laying.

| (5) | The assessment of Bacillus amyloliquefaciens CECT 5940 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation. |
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(5)

The assessment of Bacillus amyloliquefaciens CECT 5940 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation.

| (6) | As a consequence of the renewal of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 1292/2008 should be repealed. |
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(6)

As a consequence of the renewal of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 1292/2008 should be repealed.

| (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 authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’ for chickens reared for laying, and for the same category and functional group for chickens for fattening is renewed subject to the conditions laid down in that Annex.

Article 2

Regulation (EC) No 1292/2008 is repealed.

Article 3

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, 5 October 2020.

For the Commission

The President

Ursula VON DER LEYEN

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

1

(2)  Commission Regulation (EC) No 1292/2008 of 18 December 2008 concerning the authorisation of Bacillus amyloliquefaciens CECT 5940 (Ecobiol and Ecobiol plus) as a feed additive (OJ L 340, 19.12.2008, p. 36).

2

Bacillus amyloliquefaciens

(3)  EFSA Journal 2020;18(2):6014.

3

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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. |
| 4b1822 | Evonik Nutrition & Care GmbH | Bacillus amyloliquefaciens CECT 5940 | Additive composition


  Preparation of Bacillus amyloliquefaciens CECT 5940 containing a minimum of:






  — | 1 × 109 CFU/g additive |

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.

4b1822

Evonik Nutrition & Care GmbH

Bacillus amyloliquefaciens CECT 5940

Additive composition

Preparation of Bacillus amyloliquefaciens CECT 5940 containing a minimum of:

—

1 × 109 CFU/g additive

Solid forms

Chickens for fattening

Chickens reared for laying

-

1 × 109

-

| 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. | May be used in feed containing the permitted coccidiostats: diclazuril, monensin sodium, or nicarbazin. |
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2.

May be used in feed containing the permitted coccidiostats: diclazuril, monensin sodium, or nicarbazin.

| 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, glasses and gloves. |
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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, glasses and gloves.

26.10.2030

Characterisation of active substance

Spores of Bacillus amyloliquefaciens CECT 5940

Analytical method

   (1)

Enumeration: spread plate method using tryptone soya agar (EN 15 784 )

Identification: pulsed-field gel electrophoresis (PFGE) method.

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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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