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Document 02023R0366-20250108

Consolidated text: Commission Implementing Regulation (EU) 2023/366 of 16 February 2023 concerning the renewal of the authorisation of a preparation of Bacillus velezensis ATCC PTA-6737 as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species except for laying purposes, its authorisation for ornamental birds, amending Implementing Regulation (EU) No 306/2013, Implementing Regulation (EU) No 787/2013, Implementing Regulation (EU) 2015/1020, Implementing Regulation (EU) 2017/2276 and repealing Regulation (EU) No 107/2010 and Implementing Regulation (EU) No 885/2011 (holder of authorisation Kemin Europa N.V.) (Text with EEA relevance)

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ELI: http://data.europa.eu/eli/reg_impl/2023/366/2025-01-08

02023R0366 — EN — 08.01.2025 — 001.001

This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B

COMMISSION IMPLEMENTING REGULATION (EU) 2023/366

of 16 February 2023

concerning the renewal of the authorisation of a preparation of Bacillus velezensis ATCC PTA-6737 as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species except for laying purposes, its authorisation for ornamental birds, amending Implementing Regulation (EU) No 306/2013, Implementing Regulation (EU) No 787/2013, Implementing Regulation (EU) 2015/1020, Implementing Regulation (EU) 2017/2276 and repealing Regulation (EU) No 107/2010 and Implementing Regulation (EU) No 885/2011 (holder of authorisation Kemin Europa N.V.)

(Text with EEA relevance)

(OJ L 050 17.2.2023, p. 59)

Amended by:

 

 

Official Journal

  No

page

date

►M1

COMMISSION IMPLEMENTING REGULATION (EU) 2024/3166 of 18 December 2024

  L 3166

1

19.12.2024



▼B

COMMISSION IMPLEMENTING REGULATION (EU) 2023/366

of 16 February 2023

concerning the renewal of the authorisation of a preparation of Bacillus velezensis ATCC PTA-6737 as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species except for laying purposes, its authorisation for ornamental birds, amending Implementing Regulation (EU) No 306/2013, Implementing Regulation (EU) No 787/2013, Implementing Regulation (EU) 2015/1020, Implementing Regulation (EU) 2017/2276 and repealing Regulation (EU) No 107/2010 and Implementing Regulation (EU) No 885/2011 (holder of authorisation Kemin Europa N.V.)

(Text with EEA relevance)



Article 1

Renewal of the authorisation

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’ is renewed for chickens for fattening, chickens reared for laying and minor poultry species except for laying purposes, subject to the conditions laid down in that Annex.

Article 2

Authorisation

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’ is authorised for ornamental birds, subject to the conditions laid down in that Annex.

Article 3

Amendments to Implementing Regulation (EU) No 306/2013

Implementing Regulation (EU) No 306/2013 is amended as follows:

(1) 

In the title, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’.

(2) 

In the third column of the Annex, ‘Additive’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’;

(3) 

In the fourth column of the Annex, ‘Composition, chemical formula, description, analytical method’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’.

Article 4

Amendments to Implementing Regulation (EU) No 787/2013

Implementing Regulation (EU) No 787/2013 is amended as follows:

(1) 

In the title, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’;

(2) 

In the third column of the Annex, ‘Additive’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’;

(3) 

In the fourth column of the Annex, ‘Composition, chemical formula, description, analytical method’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’.

Article 5

Amendments to Implementing Regulation (EU) 2015/1020

Implementing Regulation (EU) 2015/1020 is amended as follows:

(1) 

In the title, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’;

(2) 

In the third column of the Annex, ‘Additive’, the words ‘Bacillus subtilis ATCC PTA-6737’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’;

(3) 

In the fourth column of the Annex, ‘Composition, chemical formula, description, analytical method’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’.

Article 6

Amendments to Implementing Regulation (EU) 2017/2276

Implementing Regulation (EU) 2017/2276 is amended as follows:

(1)  
In the title, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’;
(2)  
In the third column of the Annex, ‘Additive’, the words ‘Bacillus subtilis ATCC PTA-6737’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’;
(3)  
In the fourth column of the Annex, ‘Composition, chemical formula, description, analytical method’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’.

Article 7

Repeal

Regulation (EU) No 107/2010 and Implementing Regulation (EU) No 885/2011 are repealed.

Article 8

Transitional measures

1.  
The preparation specified in the Annex, as well as in Implementing Regulation (EU) No 306/2013, Implementing Regulation (EU) No 787/2013, Implementing Regulation (EU) 2015/1020 and Implementing Regulation (EU) 2017/2276, and premixtures containing it, which are produced and labelled before 9 September 2023 in accordance with the rules applicable before 9 March 2023 may continue to be placed on the market and used until the existing stocks are exhausted.
2.  
Compound feed and feed materials containing the preparation specified in the Annex, which are produced and labelled before 9 March 2024 in accordance with the rules applicable before 9 March 2023 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

Article 9

Entry into force

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.

▼M1



ANNEX



Identification number of the feed 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: zootechnical additives. Functional group: gut flora stabilisers.

4b1823i

Kemin Europa N.V.

Bacillus velezensis ATCC PTA-6737

Additive composition

Preparation of Bacillus velezensis ATCC PTA-6737 containing a minimum of 8 × 1010 CFU/g additive;

Solid form

Characterisation of the active substance

Viable spores of Bacillus velezensis ATCC PTA-6737.

Analytical method  (1)

Enumeration: Spread plate method using tryptone soya agar (EN 15784)

Identification: Pulsed-Field Gel Electrophoresis (PFGE) method or DNA sequencing methods

Chickens for fattening

Chickens reared for laying

Minor poultry species except minor poultry for laying

—

1 × 108

—

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

2.  The additive may be used simultaneously only with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: diclazuril, robenidine hydrochloride, lasalocid A sodium, maduramicin ammonium, monensin sodium, decoquinate, salinomycin sodium, narasin, narasin/nicarbazin and halofuginone.

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 breathing and skin protective equipment.

9 March 2033

Ornamental birds

 

1 × 107

 
(1)   

Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en.
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