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Commission Implementing Regulation (EU) 2024/1054 of 10 April 2024 concerning the authorisation of a preparation of Weizmannia faecalis DSM 32016 as a feed additive for use in feed and in water for drinking for all poultry species reared for laying or breeding and for use in water for drinking for all poultry species for fattening, ornamental birds, suckling and weaned Suidae piglets (holder of the authorisation: Biochem Zusatzstoffe Handels- und Produktionsges. mbH), and amending Implementing Regulation (EU) 2020/1755 as regards the terms of the authorisation of that preparation

Type Implementing Regulation

Publication 2024-04-11

Last updated 2026-04-05

State In force

Department European Commission, SANTE

Source EUR-Lex

articles 4

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Article 1

Authorisation

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised for use in feed and in water for drinking for all poultry species reared for laying or breeding, as well as in water for drinking for all poultry species for fattening, ornamental birds and suckling and weaned Suidae piglets, subject to the conditions laid down in that Annex.

Article 2

Amendment to Implementing Regulation (EU) 2020/1755

Implementing Regulation (EU) 2020/1755 is amended as follows:

(1) the title is replaced by the following: ‘Commission Implementing Regulation (EU) 2020/1755 of 24 November 2020 concerning the authorisation of a preparation of Weizmannia faecalis DSM 32016 as a feed additive for suckling and weaned Suidae piglets, poultry species for fattening and ornamental birds (holder of authorisation Biochem Zusatzstoffe Handels- und Produktionsges. mbH)’;

(2) the Annex is amended as follows:
(a) in the column ‘Additive’, the expression ‘Bacillus coagulans DSM 32016’ is replaced by ‘Weizmannia faecalis DSM 32016’;
(b) in the column ‘Composition, chemical formula, description, analytical method’, and in the sections ‘Additive composition’ and ‘Characterisation of the active substance’ thereof, the expression ‘Bacillus coagulans DSM 32016’ is replaced by ‘Weizmannia faecalis DSM 32016’;
(c) in the column ‘Other provisions’, points 2 and 3 are replaced by the following:
‘2. The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: halofuginone, diclazuril, monensin sodium, robenidine hydrochloride, salinomycin sodium, a combination of monensin sodium with nicarbazin.
1. 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.’

Article 3

Transitional measures

The preparation specified in the Annex and premixtures containing that preparation, which are intended for use in feed for suckling and weaned Suidae piglets, poultry species for fattening and ornamental birds, and which are produced and labelled before 1 November 2024 in accordance with the rules applicable before 1 May 2024 may continue to be placed on the market and used until the existing stocks are exhausted.

Compound feed and feed materials containing the preparation specified in the Annex, which are intended for suckling and weaned Suidae piglets, poultry species for fattening and ornamental birds, and which are produced and labelled before 1 May 2025 in accordance with the rules applicable before 1 May 2024 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4

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.

ANNEX

PART I

Identification number of the additive	Name of the holder of authorisation	Name of the additive	Composition, chemical formula, description, analytical method	Species or category of animal	Maximum age	Minimum content	Maximum content	Mini-mum content	Maximum content	Other provisions	End of period of authorisation
Identification number of the additive	Name of the holder of authorisation	Name of the additive	Composition, chemical formula, description, analytical method	Species or category of animal	Maximum age	CFU/kg of complete feed with a moisture content of 12 %	CFU/kg of complete feed with a moisture content of 12 %	CFU/l of water for drinking	CFU/l of water for drinking	Other provisions	End of period of authorisation
Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers
4b1900	Name of the holder of authorisation	Name of the additive	Composition, chemical formula, description, analytical method	Species or category of animal	Maximum age	Biochem Zusatzstoffe Handels- und Produktionsges. mbH	Weizmannia faecalis DSM 32016	Additive composition Preparation of Weizmannia faecalis DSM 32016 containing a minimum of 2 × 10¹⁰ CFU/g additive Solid form Characterisation of the active substance Viable spores of Weizmannia faecalis DSM 32016 Analytical method [^E0001] Identification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697. Enumeration in the feed additive, premixtures, compound feed and water for drinking: Spread plate method on MRS agar (based on EN 15787 method).	All poultry species reared for laying All poultry species reared for breeding	Other provisions	End of period of authorisation	-	1 × 10⁹	-	5 × 10⁸	-	1. In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated. 2. The additive may be used via water for drinking. 3. The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: halofuginone, diclazuril, monensin sodium, robenidine hydrochloride, salinomycin sodium, amprolium, a combination of monensin sodium with nicarbazin and a combination of narasin and nicarbazin. 4. 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.	1 May 2034

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.

PART II

Identification number of the additive	Name of the holder of authorisation	Name of the 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
Identification number of the additive	Name of the holder of authorisation	Name of the additive	Composition, chemical formula, description, analytical method	Species or category of animal	Maximum age	CFU/l of water for drinking	CFU/l of water for drinking	Other provisions	End of period of authorisation
Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers
4b1900	Name of the holder of authorisation	Name of the additive	Composition, chemical formula, description, analytical method	Species or category of animal	Maximum age	Biochem Zusatzstoffe Handels- und Produktionsges. mbH	Weizmannia faecalis DSM 32016	Other provisions	End of period of authorisation	Additive composition Preparation of Weizmannia faecalis DSM 32016 containing a minimum of 2 × 10¹⁰ CFU/g additive Solid form Characterisation of the active substance Viable spores of Weizmannia faecalis DSM 32016 Analytical method [^E0002] Identification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697. Enumeration in the feed additive, premixtures, compound feed and water for drinking: Spread plate method on MRS agar (based on EN 15787 method).	All poultry species for fattening Suckling and weaned Suidae piglets Ornamental birds	-	5 × 10⁸	-	1. In the directions for use of the additive, the storage conditions and the stability in water for drinking shall be indicated. 2. The additive shall be used via water for drinking. 3. The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: halofuginone, diclazuril, monensin sodium, robenidine hydrochloride, salinomycin sodium, amprolium, a combination of monensin sodium with nicarbazin and a combination of narasin and nicarbazin. 4. 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.	1 May 2034

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