# L_2020034EN.01002801.xml

| 6.2.2020 | EN | Official Journal of the European Union | L 34/28 |
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6.2.2020

EN

Official Journal of the European Union

L 34/28

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/161

of 5 February 2020

concerning the renewal of the authorisation of Bacillus subtilis DSM 17299 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1137/2007 (holder of authorisation Chr. Hansen A/S)

(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 subtilis DSM 17299 was authorised for 10 years as a feed additive for chickens for fattening by Commission Regulation (EC) No 1137/2007 (2). |
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(2)

Bacillus subtilis DSM 17299 was authorised for 10 years as a feed additive for chickens for fattening by Commission Regulation (EC) No 1137/2007 (2).

| (3) | In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted by the holder of that authorisation for the renewal of the authorisation of Bacillus subtilis DSM 17299 as a feed additive for chickens for fattening, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. |
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(3)

In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted by the holder of that authorisation for the renewal of the authorisation of Bacillus subtilis DSM 17299 as a feed additive for chickens for fattening, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 2 April 2019 (3) that the applicant has provided data demonstrating that the additive complies with the existing conditions of authorisation. The Authority confirmed its previous conclusions that Bacillus subtilis DSM 17299 is considered safe for the target species, consumers of products from animals fed with the additive and the environment. It also concluded that there is a potential for users to be exposed via inhalation and that no conclusion could be drawn on the potential for skin and eyes irritancy and dermal sensitisation. Therefore the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive |
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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 2 April 2019 (3) that the applicant has provided data demonstrating that the additive complies with the existing conditions of authorisation. The Authority confirmed its previous conclusions that Bacillus subtilis DSM 17299 is considered safe for the target species, consumers of products from animals fed with the additive and the environment. It also concluded that there is a potential for users to be exposed via inhalation and that no conclusion could be drawn on the potential for skin and eyes irritancy and dermal sensitisation. Therefore the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive

| (5) | The assessment of Bacillus subtilis DSM 17299 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 subtilis DSM 17299 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 subtilis DSM 17299 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 1137/2007 should be repealed. |
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(6)

As a consequence of the renewal of the authorisation of Bacillus subtilis DSM 17299 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 1137/2007 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’, is renewed subject to the conditions laid down in that Annex.

Article 2

Regulation (EC) No 1137/2007 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 February 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 1137/2007 of 1 October 2007 concerning the authorisation of Bacillus subtilis (O35) as a feed additive (OJ L 256, 2.10.2007, p. 5).

2

Bacillus subtilis

(3)  
  EFSA Journal 2019;17(4):5687.

3

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 |
| 4b1821 | Chr. Hansen A/S | Bacillus subtilis DSM 17299 | Additive composition

  Preparation of Bacillus subtilis DSM 17299, containing a minimum of 1,6 × 1010 CFU/g of additive
  Solid form | Chickens for fattening | — | 8 × 108 | — | 1. | In the directions for use of the additive and premixtures, 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

4b1821

Chr. Hansen A/S

Bacillus subtilis DSM 17299

Additive composition

Preparation of Bacillus subtilis DSM 17299, containing a minimum of 1,6 × 1010 CFU/g of additive

Solid form

Chickens for fattening

—

8 × 108

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1.

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

| 2. | The use is permitted in feed containing one of the following authorised coccidiostats: diclazuril, halofuginone, robenidine, decoquinate, narasin/nicarbazin, lasalocid sodium, maduramycin ammonium, monensin sodium, narasin, salinomycin sodium or semduramycin sodium. |
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2.

The use is permitted in feed containing one of the following authorised coccidiostats: diclazuril, halofuginone, robenidine, decoquinate, narasin/nicarbazin, lasalocid sodium, maduramycin ammonium, monensin sodium, narasin, salinomycin sodium or semduramycin sodium.

| 3. | The compatibility of this additive with formic acid has been shown. |
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3.

The compatibility of this additive with formic acid has been shown.

| 4. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its 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, skin and eye protections. |
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4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its 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, skin and eye protections.

26 February 2030

Characterisation of the active substance

Viable spore of Bacillus subtilis DSM 17299

Analytical method
   (1)

Enumeration spread plate method using tryptone soya agar (EN 15784)

Identification of Bacillus subtilis DSM 17299 in the feed additive:

Pulsed Field Gel Electrophoresis (PFGE).

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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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