Commission Implementing Regulation (EU) 2026/553 of 13 March 2026 amending Implementing Regulations (EU) 2020/1755 and (EU) 2024/1054 as regards the terms of the authorisation of a preparation of Weizmannia faecalis DSM 32016 as a feed additive for all poultry species for fattening, reared for breeding and laying and ornamental birds (holder of authorisation: Biochem Zusatzstoffe Handels- und Produktionsges. mbH)

Official Journal EN of the European Union L series 2026/553 16.3.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/553 of 13 March 2026 amending Implementing Regulations (EU) 2020/1755 and (EU) 2024/1054 as regards the terms of the authorisation of a preparation of Weizmannia faecalisDSM 32016 as a feed additive for all poultry species for fattening, reared for breeding and laying and ornamental birds (holder of authorisation:

Biochem Zusatzstoffe Handels- und Produktionsges. mbH) (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 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 and modifying such authorisation.

(2) A preparation of Weizmannia faecalisDSM 32016 was authorised for a period of 10 years as a feed additive for use in feed for suckling and weaned Suidae piglets, poultry for fattening and ornamental birds by Commission Implementing Regulation (EU) 2020/1755(2)and 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 by Commission Implementing Regulation (EU) 2024/1054(3).

(3) In accordance with Article 13(3) of Regulation (EC) No 1831/2003, an application was submitted on 8 August 2024 for the modification of the terms of the authorisation of the preparation of Weizmannia faecalisDSM 32016 as a feed additive for use in feed and in water for drinking for all poultry species for fattening, reared for breeding and laying and ornamental birds, requesting to allow the simultaneous use of that preparation with the coccidiostat amprolium and a combination of coccidiostats narasin and nicarbazin, which are authorised as feed additives. The request was accompanied by the relevant supporting data.

(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2) Commission Implementing Regulation (EU) 2020/1755 of 24 November 2020 concerning the authorisation of a preparation of Weizmannia faecalisDSM 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) (OJ L 395, 25.11.2020, p. 5; ELI: http://data.

europa.eu/eli/reg_impl/2020/1755/oj).

(3) Commission Implementing Regulation (EU) 2024/1054 of 10 April 2024 concerning the authorisation of a preparation of Weizmannia faecalis DSM 32016as 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 (OJ L, 2024/1054, 11.4.2024, ELI: http://data.europa. eu/eli/reg_impl/2024/1054/oj).

ELI: http://data.europa.eu/eli/reg_impl/2026/553/oj 1/9EN OJ L, 16.3.2026

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 25 June 2025(4)that the proposed modification in the terms of the authorisation of the preparation of Weizmannia faecalis DSM 32016 would not change the conclusions previously drawn regarding the safety of that additive for the target species, consumers and the environment. The Authority also concluded that the preparation of Weizmannia faecalisDSM 32016 is not a skin or eye irritant but should be considered a skin and respiratory sensitiser, and inhalation and dermal exposure are considered a risk. It also concluded that the use of that preparation is compatible with the coccidiostat amprolium and the combination of coccidiostats narasin and nicarbazin under the currently authorised conditions of use. The Authority did not consider that there is a need for specific requirements for a post-market monitoring.

(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment concerning another application for the authorisation of the same additive and verified by the Authority in its opinion of 25 May 2020(5)are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005(6), an evaluation report of the Reference Laboratory was therefore not required.

(6) In view of the above, the Commission considers that the preparation of Weizmannia faecalisDSM 32016 still satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003 when modifying the terms of the authorisation laid down in Implementing Regulations (EU) 2020/1755 and (EU) 2024/1054, by specifying the compatibility of the use of that preparation with the coccidiostat amprolium and a combination of coccidiostats narasin and nicarbazin. In addition, considering that those coccidiostats may not be authorised as feed additives for each of the species or categories listed in Annexes I and II, their simultaneous use with the preparation of Weizmannia faecalis DSM 32016 should only be possible in accordance with their respective conditions of authorisation as feed additives.

(7) Implementing Regulations (EU) 2020/1755 and (EU) 2024/1054 should therefore be amended accordingly.

(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of Weizmannia faecalis DSM 32016 for all poultry species for fattening, reared for breeding and laying and ornamental birds, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the modification of the authorisation concerned.

(9) 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 Amendment to Implementing Regulation (EU) 2020/1755 The Annex to Implementing Regulation (EU) 2020/1755 is replaced by Annex I to this Regulation.

(4) EFSA Journal. 2025;23:e9548. https://doi.org/10.2903/j.efsa.2025.9548.

(5) EFSA Journal2020;18(6):6158. https://doi.org/10.2903/j.efsa.2020.6158.

(6) 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).

2/9 ELI: http://data.europa.eu/eli/reg_impl/2026/553/ojEN OJ L, 16.3.2026 Article 2 Amendment to Implementing Regulation (EU) 2024/1054 The Annex to Implementing Regulation (EU) 2024/1054 is replaced by Annex II to this Regulation.

Article 3 Transitional measures

1. The feed additive Weizmannia faecalisDSM 32016, as authorised by Implementing Regulations (EU) 2020/1755 and

(EU) 2024/1054 and premixtures containing that additive, which are intended for all poultry species for fattening, reared for breeding and laying and ornamental birds, and which are produced and labelled before 5 October 2026 in accordance with the rules applicable 5 April 2026 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 all poultry species for fattening, reared for breeding and laying and ornamental birds, and which are produced and labelled before 5 April 2027 in accordance with the rules applicable before 5 April 2026 may continue to be placed on the market and used until the stocks concerned 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.

Done at Brussels, 13 March 2026.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_impl/2026/553/oj 3/9ANNEX I Minimum Maximum content content Identification Composition, chemical Name of the holder of Name of the Species or category Maximum End of period of number of formula, description, Other provisions authorisation additive of animal age CFU/kg of complete feed authorisation the additive analytical method with a moisture content of 12 %

Category: zootechnical additives. Functional group: gut flora stabilisers 4b1900 Biochem Zusatzstoffe Weizmannia Additive composition Suckling and - 1 × 109 - 1. In the directions for use of 15.12.2030 Handels- und faecalisDSM weaned Suidae the additive and Preparation of Produktionsges. mbH 32016 piglets premixtures, the storage Weizmannia faecalisDSM conditions and stability 32016 containing a Poultry for to heat treatment shall be minimum of 2 × 1010 fattening indicated.

CFU/g additive Solid form Ornamental 2. The additive may be used simultaneously with the birds following coccidiostats, Characterisation of the in accordance with their active substance respective conditions of Viable spores of cells of authorisation as feed

Weizmannia faecalisDSM additives: halofuginone, 32016 diclazuril, monensin sodium, robenidine Analytical method(1) hydrochloride, salinomycin sodium,

Identification: DNA amprolium, a sequencing methods or combination of Pulsed Field Gel monensin sodium with Electrophoresis (PFGE) – nicarbazin and a CEN/TS 17697. combination of narasin and nicarbazin.

4/9

ELI:

http://data.europa.eu/eli/reg_impl/2026/553/oj EN OJ L,

16.3.2026Minimum Maximum content content Identification Composition, chemical Name of the holder of Name of the Species or category Maximum End of period of number of formula, description, Other provisions authorisation additive of animal age CFU/kg of complete feed authorisation the additive analytical method with a moisture content of 12 % Enumeration in the feed 3. For users of the additive additive, premixtures, and premixtures, feed compound feed and business operators shall

water for drinking: establish operational Spread plate method on procedures and MRS agar (based on EN organisational measures 15787 method). 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) 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/2026/553/oj 5/9 OJ L,

16.3.2026 ENANNEX II PART I Mini- Minimum Maximum Maximum mum content content content Identification Name of the Composition, chemical Species or content End of period Name of the Maximum number of holder of formula, description, category of Other provisions of additive age the additive authorisation analytical method animal CFU/kg of complete authorisation CFU/l of water for feed with a moisture drinking content of 12 %

Category: zootechnical additives. Functional group: gut flora stabilisers 4b1900 Biochem Weizmannia Additive composition All poultry - 1 × 109 - 5 × 108 - 1. In the directions for use of 1 May 2034 Zusatzstoffe faecalisDSM species the additive and Preparation of Handels- und 32016 reared for premixtures, the storage Weizmannia faecalis Produktions­ laying conditions, the stability to DSM 32016 containing ges. mbH heat treatment and the a minimum of 2 × 1010 All poultry stability in water for CFU/g additive species drinking shall be indicated.

Solid form reared for breeding 2. The additive may be used via water for drinking.

Characterisation of the active substance

3. The additive may be used Viable spores of simultaneously with the Weizmannia faecalis following coccidiostats, in DSM 32016 accordance with their respective conditions of Analytical method(1) authorisation as feed

additives: halofuginone,

Identification: DNA diclazuril, monensin sequencing methods or sodium, robenidine Pulsed Field Gel hydrochloride, salinomycin Electrophoresis (PFGE) sodium, amprolium, a – CEN/TS 17697. combination of monensin sodium with nicarbazin and a combination of narasin and nicarbazin.

6/9

ELI:

http://data.europa.eu/eli/reg_impl/2026/553/oj EN OJ L,

16.3.2026Mini- Minimum Maximum Maximum mum content content content Identification Name of the Composition, chemical Species or content End of period Name of the Maximum number of holder of formula, description, category of Other provisions of additive age the additive authorisation analytical method animal CFU/kg of complete authorisation CFU/l of water for feed with a moisture drinking content of 12 % Enumeration in the 4. For users of the additive and feed additive, premixtures, feed business premixtures, operators shall establish compound feed and operational procedures and

water for drinking: organisational measures to Spread plate method on address potential risks MRS agar (based on EN resulting from their use.

15787 method). 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) 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/2026/553/oj 7/9 OJ L, 16.3.2026 ENPART II Minimum Maximum Identification Composition, chemical content content Name of the holder of Name of the Species or category Maximum End of period of number of formula, description, Other provisions authorisation additive of animal age authorisation the additive analytical method CFU/l of water for drinking

Category: zootechnical additives. Functional group: gut flora stabilisers 4b1900 Biochem Zusatzstoffe Weizmannia Additive composition All poultry - 5 × 108 - 1. In the directions for use of 1 May 2034 Handels- und faecalisDSM species for the additive, the storage Preparation of Produktionsges. mbH 32016 fattening conditions and the Weizmannia faecalisDSM stability in water for 32016 containing a Suckling and drinking shall be minimum of 2 × 1010 weaned Suidae indicated.

CFU/g additive piglets Solid form 2. The additive shall be used Ornamental via water for drinking.

Characterisation of the birds active substance 3. The additive may be used simultaneously with the Viable spores of following coccidiostats, Weizmannia faecalisDSM in accordance with their 32016 respective conditions of authorisation as feed Analytical method(1)

additives: halofuginone,

Identification: DNA diclazuril, monensin sequencing methods or sodium, robenidine Pulsed Field Gel hydrochloride, Electrophoresis (PFGE) – salinomycin sodium, CEN/TS 17697. amprolium, a combination of monensin sodium with nicarbazin and a combination of narasin and nicarbazin.

8/9

ELI:

http://data.europa.eu/eli/reg_impl/2026/553/oj EN OJ L,

16.3.2026Minimum Maximum Identification Composition, chemical content content Name of the holder of Name of the Species or category Maximum End of period of number of formula, description, Other provisions authorisation additive of animal age authorisation the additive analytical method CFU/l of water for drinking Enumeration in the feed 4. For users of the additive additive, premixtures, and premixtures, feed compound feed and business operators shall

water for drinking: establish operational Spread plate method on procedures and MRS agar (based on EN organisational measures 15787 method). 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) 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/2026/553/oj 9/9 OJ L,

16.3.2026 EN