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

• CELEX: Implementing Regulation (EU) 2024/1054
• Articles: 5

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.

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.’

Article 3 Transitional measures

1.   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.

2.   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.

Schedules & Appendices

ANNEX

ANNEX

PART 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

Minimum content

Maximum content

Other provisions

End of period of authorisation

CFU/kg of complete feedingstuff with a moisture content of 12 %

CFU/l of water for drinking

Category: zootechnical additives. Functional group: gut flora stabilisers

4b1900

Biochem Zusatzstoffe Handels- und Produktionsges. mbH

Weizmannia faecalis DSM 32016

Additive composition

Preparation of Weizmannia faecalis DSM 32016 containing a minimum of 2 × 10 10 CFU/g additive

Solid form

Characterisation of the active substance

Viable spores of Weizmannia faecalis DSM 32016

Analytical method

( 1 )

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

Enumeration in the feed additive, premixtures, compound feed and water: Spread plate method on MRS agar (based on EN 15787 method).

All poultry species reared for laying

All poultry species reared for breeding

—

1 × 10 9

—

5 × 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 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, a combination of monensin sodium with 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

PART 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/l of water for drinking

Category: zootechnical additives. Functional group: gut flora stabilisers

4b1900

Biochem Zusatzstoffe Handels- und Produktionsges. mbH

Weizmannia faecalis DSM 32016

Additive composition

Preparation of Weizmannia faecalis DSM 32016 containing a minimum of 2 × 10 10 CFU/g additive

Solid form

Characterisation of the active substance

Viable spores of Weizmannia faecalis DSM 32016

Analytical method

( 2 )

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

Enumeration in the feed additive, premixtures, compound feed and water: Spread plate method on MRS agar (based on EN 15787 method).

All poultry species for fattening

Suckling and weaned Suidae piglets

Ornamental birds

—

5 × 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 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, a combination of monensin sodium with 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

( 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

( 2 )   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