2024/3166

19.12.2024

COMMISSION IMPLEMENTING REGULATION (EU) 2024/3166

of 18 December 2024

concerning the renewal of the authorisation of a preparation of

Bacillus velezensis

ATCC PTA-6737 as a feed additive for turkeys for fattening, turkeys reared for breeding, weaned piglets, weaned Suidae other than

Sus scrofa domesticus

, and sows, its authorisation for pigs for fattening of all Suidae species, suckling piglets of all Suidae species and sows of minor Suidae species (holder of authorisation: Kemin Europa N.V.), amending Implementing Regulation (EU) 2023/366 and repealing Implementing Regulations (EU) No 306/2013, (EU) No 787/2013 and (EU) 2017/2276

(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) and Article 13(3) 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, modifying and renewing such an authorisation.

(2) A preparation of

Bacillus velezensis

ATCC PTA-6737, previously taxonomically identified as

Bacillus subtilis

ATCC PTA-6737, was authorised for a period of 10 years as a feed additive for turkeys for fattening and turkeys reared for breeding by Commission Implementing Regulation (EU) No 787/2013 (2), for weaned piglets and weaned Suidae other than

Sus scrofa domesticus

by Commission Implementing Regulation (EU) No 306/2013 (3), for sows by Commission Implementing Regulation (EU) 2017/2276 (4) and for chickens for fattening, chickens reared for laying and minor poultry species except minor poultry for laying by Commission Implementing Regulation (EU) 2023/366 (5).

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of

Bacillus velezensis

ATCC PTA-6737 as a feed additive for turkeys for fattening and turkeys reared for breeding, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’. That application included a proposal for amending the conditions of the original authorisation, consisting in an increase of the minimum concentration of the active agent in the preparation from 1 × 10

CFU/g additive to 8 × 10

CFU/g additive and an addition of the possibility to use the additive in combination with the coccidiostat halofuginone. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

(4) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, another application was submitted for the renewal of the authorisation of the preparation of

Bacillus velezensis

ATCC PTA-6737 as a feed additive for weaned piglets, weaned Suidae other than

Sus scrofa domesticus

, and sows, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’. That application included a proposal for amending the conditions of the original authorisations, consisting in an increase of the minimum concentration of the active agent in the preparation from 1 × 10

CFU/g additive to 8 × 10

CFU/g additive, and, as regards the use for sows, in a removal of the restriction of use in sows from three weeks before farrowing to whole lactation period. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

(5) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of new uses of the preparation of

Bacillus velezensis

ATCC PTA-6737. That application concerned an extension of the authorisation of the preparation as a feed additive to all growing Suidae, sows and minor reproductive porcine species, which corresponds to a new use for pigs for fattening of all Suidae species, suckling piglets of all Suidae species and sows of minor Suidae species. The application requested that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’ and was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(6) In accordance with Article 13(3) of Regulation (EC) No 1831/2003, an application was submitted for the modification of the terms of the authorisation of the preparation of

Bacillus velezensis

ATCC PTA-6737 as laid down in Implementing Regulation (EU) 2023/366 as regards the use for chickens for fattening, chickens reared for laying and minor poultry species except for laying. That application concerned a request to increase the minimum content of the additive from 1 × 10

CFU/kg of complete feed to 1 × 10

CFU/kg of complete feed and to add the possibility to use the additive in combination with the coccidiostat halofuginone.

(7) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 5 January 2024 (6) and 2 February 2024 (7) that, under the current authorised conditions of use and considering the fact that the composition and manufacturing process of the additive has not been substantially modified, the preparation of

Bacillus velezensis

ATCC PTA-6737 remains safe for all poultry species, weaned piglets, weaned Suidae other than

Sus scrofa domesticus

, and sows, the consumers and the environment. It also concluded that the additive is safe for all Suidae, for the consumers and the environment. The Authority also concluded that the preparation is not irritant to the skin and eyes, but that it should be considered a respiratory sensitiser, while no conclusion could be drawn on the potential of the additive to be a skin sensitiser. The Authority considered that the additive has the potential to be efficacious in poultry for fattening and reared for laying/breeding (‘all growing poultry’) at the minimum use level of 1 × 10

CFU/kg complete feed and in all growing Suidae (suckling, weaned and fattening categories) at the minimum inclusion level of 1 × 10

CFU/kg complete feed and in sows and minor reproductive Suidae species at 1 × 10

CFU/kg of complete feed. The Authority further concluded in its opinion of 2 February 2024 concerning the use of the additive for poultry that the additive is compatible with the coccidiostat halofuginone. The Authority did not consider that there is a need for specific requirements for a post-market monitoring.

(8) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of

Bacillus velezensis

ATCC PTA-6737 as a feed additive in the context of the previous authorisations are valid and applicable for the current applications. In accordance with Article 5(4), points (a), (b) and (c), of Commission Regulation (EC) No 378/2005 (8), an evaluation report of the Reference Laboratory is therefore not required.

(9) In view of the above, the Commission considers that the preparation of

Bacillus velezensis

ATCC PTA-6737 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed for turkeys for fattening, turkeys reared for breeding, weaned piglets, weaned Suidae other than

Sus scrofa domesticus

, and sows. Furthermore, the use of the additive should be authorised for pigs for fattening of all Suidae species, suckling piglets of all Suidae species and sows of minor Suidae species. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.

(10) In addition, in view of the above, the Commission considers that the authorisation of the preparation of

Bacillus velezensis

ATCC PTA-6737 still meets the conditions provided for in Article 5 of Regulation (EC) No 1831/2003 when modifying the terms thereof as regards the use for chickens for fattening, chickens reared for laying and minor poultry species except for laying, by increasing the minimum content of the additive to 1 × 10

CFU/kg of complete feed and by adding the possibility to use the additive in combination with the coccidiostat halofuginone. Implementing Regulation (EU) 2023/366 should therefore be amended accordingly.

(11) As a consequence of the renewal of the authorisation of the preparation of

Bacillus velezensis

ATCC PTA-6737 as a feed additive for turkeys for fattening, turkeys reared for breeding, weaned piglets, weaned Suidae other than

Sus scrofa domesticus

, and sows, Implementing Regulations (EU) No 306/2013, (EU) No 787/2013 and (EU) 2017/2276 should be repealed.

(12) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of

Bacillus velezensis

ATCC PTA-6737 for turkeys for fattening, turkeys reared for breeding, chickens for fattening, chickens reared for laying, minor poultry species except for laying, weaned piglets, weaned Suidae other than

Sus scrofa domesticus

, and sows, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal or the modification of the authorisations concerned.

(13) 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

Renewal of the authorisation

The authorisation of the preparation specified in Annex I, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed for turkeys for fattening, turkeys reared for breeding, weaned piglets, weaned Suidae other than

Sus scrofa domesticus

, and sows, subject to the conditions laid down in that Annex.

Article 2

Authorisation

The preparation specified in Annex I, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition for pigs for fattening of all Suidae species, suckling piglets of all Suidae species and sows of minor Suidae species, subject to the conditions laid down in that Annex.

Article 3

Amendment to Implementing Regulation (EU) 2023/366

The Annex to Implementing Regulation (EU) 2023/366 is replaced by Annex II to this Regulation.

Article 4

Repeal

Implementing Regulations (EU) No 306/2013, (EU) No 787/2013 and (EU) 2017/2276 are repealed.

Article 5

Transitional measures

1. The feed additive

Bacillus velezensis

ATCC PTA-6737, as authorised by Implementing Regulations (EU) No 306/2013, (EU) No 787/2013, (EU) 2017/2276 and (EU) 2023/366 and premixtures containing that additive, which are intended for turkeys for fattening, turkeys reared for breeding, chickens for fattening, chickens reared for laying, minor poultry species except for laying, weaned piglets, weaned Suidae other than

Sus scrofa domesticus

, and sows, and which are produced and labelled before 8 July 2025 in accordance with the rules applicable before 8 January 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.

2. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for turkeys for fattening, turkeys reared for breeding, chickens for fattening, chickens reared for laying, minor poultry species except for laying, weaned piglets, weaned Suidae other than

Sus scrofa domesticus

, and sows, and which are produced and labelled before 8 January 2026 in accordance with the rules applicable before 8 January 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.

Article 6

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.

Done at Brussels, 18 December 2024.

For the Commission

The President

Ursula VON DER LEYEN

(1)

OJ L 268, 18.10.2003, p. 29

, ELI:

http://data.europa.eu/eli/reg/2003/1831/oj

(2) Commission Implementing Regulation (EU) No 787/2013 of 16 August 2013 concerning the authorisation of a preparation of

Bacillus subtilis

(ATCC PTA-6737) as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of authorisation Kemin Europa N.V.) (

OJ L 220, 17.8.2013, p. 15

, ELI:

http://data.europa.eu/eli/reg_impl/2013/787/oj

(3) Commission Implementing Regulation (EU) No 306/2013 of 2 April 2013 concerning the authorisation of a preparation of

Bacillus subtilis

(ATCC PTA-6737) for weaned piglets and weaned Suidae other than

Sus scrofa domesticus

(holder of authorisation Kemin Europa N.V.) (

OJ L 91, 3.4.2013, p. 5

, ELI:

http://data.europa.eu/eli/reg_impl/2013/306/oj

(4) Commission Implementing Regulation (EU) 2017/2276 of 8 December 2017 concerning the authorisation of a new use of the preparation of

Bacillus subtilis

(ATCC PTA-6737) as a feed additive for sows (holder of the authorisation Kemin Europa N.V.) (

OJ L 326, 9.12.2017, p. 50

, ELI:

http://data.europa.eu/eli/reg_impl/2017/2276/oj

(5) 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.) (

OJ L 50, 17.2.2023, p. 59

, ELI:

http://data.europa.eu/eli/reg_impl/2023/366/oj

(6)

EFSA Journal

; 2024;22:e8562.

(7)

EFSA Journal

; 2024;22:e8650.

(8) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (

OJ L 59, 5.3.2005, p. 8

, ELI:

http://data.europa.eu/eli/reg/2005/378/oj

ANNEX I

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 cells of Bacillus velezensis ATCC PTA-6737.

Analytical method (1)

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

Identification: Pulsed-Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods

Pigs for fattening of all Suidae species

Piglets of all Suidae species

—

1 × 107

—

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

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.

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 by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment.

8 January 2035

Sows of all Suidae species

Turkeys for fattening and turkeys reared for breeding

1 × 108

(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

ANNEX II

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.

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

ELI: http://data.europa.eu/eli/reg_impl/2024/3166/oj

ISSN 1977-0677 (electronic edition)