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)

• CELEX: Implementing Regulation (EU) 2023/366
• Articles: 10

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.

Schedules & Appendices

ANNEX

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: 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 × 10 10 CFU/g

Chickens for fattening

Chickens reared for laying

Minor poultry species except minor poultry for laying

Ornamental birds

-

1 × 10 7

-

1.

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

2.

The additive is compatible with the following coccidiostats, provided they are authorised for the relevant species: diclazuril, decoquinate, salinomycin sodium, narasin/nicarbazin, lasalocid A sodium, maduramycin ammonium, monensin sodium, narasin or robenidine hydrochloride.

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.

9 March 2033

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

( 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