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
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
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.
Amendment to Implementing Regulation (EU) 2023/366
The Annex to Implementing Regulation (EU) 2023/366 is replaced by Annex II to this Regulation.
Repeal
Implementing Regulations (EU) No 306/2013, (EU) No 787/2013 and (EU) 2017/2276 are repealed.
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.
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.
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 × 10 10 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 × 10 7 — 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 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 × 10 8 ( 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 × 10 10 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 × 10 8 — 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 × 10 7 ( 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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