Commission Implementing Regulation (EU) 2026/534 of 11 March 2026 concerning the authorisation of a preparation of Duddingtonia flagrans NCIMB 30336 as a feed additive for grazing animals of bovine, ovine and caprine species other than for milk production, and for grazing animals of camelids, cervids, equines, porcine species and rabbits (holder of authorisation: International Animal Health Products Pty Ltd, represented in the Union by SynTech Regulatory Europe GmbH)

Official Journal EN of the European Union L series 2026/534 12.3.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/534 of 11 March 2026 concerning the authorisation of a preparation of Duddingtonia flagransNCIMB 30336 as a feed additive for grazing animals of bovine, ovine and caprine species other than for milk production, and for grazing animals of camelids, cervids, equines, porcine species and rabbits (holder of

authorisation: International Animal Health Products Pty Ltd, represented in the Union by SynTech Regulatory Europe GmbH) (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) 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 such an authorisation.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Duddingtonia flagrans NCIMB 30336. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The application concerns the authorisation of a preparation of Duddingtonia flagransNCIMB 30336 as a feed additive for all grazing animals, requesting that additive to be classified in the category ‘zootechnical additives’, in the functional group ‘other zootechnical additives’.

(4) Commission Implementing Regulation (EU) 2024/1723(2) authorised the preparation of Duddingtonia flagrans NCIMB 30336 as a feed additive for grazing animals for milk production of bovine species, sheep, and goats since, due to the lack of data, the European Food Safety Authority (‘the Authority’) could not conclude on the safety of the additive for other grazing animal species and categories in its opinions of 2 July 2020(3)and 14 November 2023(4).

(5) Therefore, only the use of that preparation as a feed additive for all grazing animals other than grazing animals for milk production of bovine species, sheep, and goats remains to be addressed in that application.

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

(2) Commission Implementing Regulation (EU) 2024/1723 of 20 June 2024 concerning the authorisation of a preparation of Duddingtonia flagransNCIMB 30336 as a feed additive for grazing animals for milk production of bovine species, sheep and goats (holder of authorisation: International Animal Health Products Pty Ltd, represented by GAB Consulting GmbH) (OJ L, 2024/1723,

21.6.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/1723/oj).

(3) EFSA Journal. 2020;18(7):6208, https://doi.org/10.2903/j.efsa.2020.6208.

(4) EFSA Journal. 2023;21:e8465, https://doi.org/10.2903/j.efsa.2023.8465.

ELI: http://data.europa.eu/eli/reg_impl/2026/534/oj 1/4EN OJ L, 12.3.2026

(6) The Authority concluded in its opinions of 2 July 2020 and 20 March 2025(5)that, under the proposed conditions of use, the preparation of Duddingtonia flagrans NCIMB 30336 is safe for all grazing bovines, ovines, caprines, rabbits, horses, cervids, camelids and porcine species, as well as for consumers and the environment. The Authority considered that the preparation of Duddingtonia flagransNCIMB 30336 is not irritant to skin and eyes but is irritant to the respiratory tract and is a respiratory sensitiser, while no conclusion could be drawn on its skin sensitisation potential. The Authority further concluded that the preparation of Duddingtonia flagransNCIMB 30336 can reduce the number of parasitic nematodes on pasture to the benefit of grazing animals, when used at the recommended application rate of 3 × 104chlamydospores/kg body weight and per day. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(7) On 18 June 2025, the applicant withdrew the application for the authorisation of the preparation for all grazing animals other than bovines, ovines, caprines, camelids, cervids, equines, porcine species and rabbits.

(8) In view of the above, the Commission considers that the preparation of Duddingtonia flagransNCIMB 30336 satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for grazing animals of bovine, ovine and caprine species other than for milk production, and for grazing animals of camelid species, cervid species, horses, porcine species and rabbits.

Considering the conclusion of the Authority on the safety of the preparation of Duddingtonia flagransNCIMB 30336 for grazing horses and taking into account that interspecies extrapolation of data can be applied between physiologically similar species(6), the Commission considers that the authorisation of that preparation should be extended to grazing equines. In addition, it is appropriate, for practical and control reasons, to express the dosage of the preparation per kilogram of complete feedingstuff and to provide for the additive to be used only in feed for grazing animals. Finally, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.

(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 Authorisation The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

(5) EFSA Journal. 2025;23:e9366, https://doi.org/10.2903/j.efsa.2025.9366.

(6) As set out in the Guidance on the assessment of the safety of feed additives for the target species. EFSA Journal2017;15(10):5021,

https://doi.org/10.2903/j.efsa.2017.5021.

2/4 ELI: http://data.europa.eu/eli/reg_impl/2026/534/ojEN OJ L, 12.3.2026 Article 2 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, 11 March 2026.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_impl/2026/534/oj 3/4ANNEX Minimum Maximum content content Identification Name of the Name of the Composition, chemical formula, Species or category Maximum End of period number of holder of Number of Other provisions additive description, analytical method of animal age of authorisation the additive authorisation chlamydospores/kg of complete feed with a moisture content of 12 %

Category: zootechnical additives. Functional group: other zootechnical additives (reduction of the number of infective nematode larvae on pasture) 4d27 International Duddingtonia Additive composition Cows for - 8,5 × 105 8,5 × 106 1. In the directions for use of 1 April 2036 Animal Health flagrans reproduction the additive and Preparation of Duddingtonia Products Pty NCIMB 30336 and bulls premixtures, the storage flagransNCIMB 30336, Ltd, Cows for conditions and stability to containing a minimum of 5 × represented by reproduction heat treatment shall be 105chlamydospores/g SynTech and bulls of indicated.

additive.

Regulatory minor bovine Solid form. 2. The additive shall only be Europe GmbH species used in feed for grazing Characterisation of the active Bovines for - 1,3 × 106 2,6 × 106 animals. substance fattening

3. The additive shall be used at Viable chlamydospores of Ovines other the minimum dose of 3 × 104 Duddingtonia flagransNCIMB than dairy sheep chlamydospores/kg 30336 bodyweight and day.

Caprines other Analytical methods(1) than dairy goats 4. For users of the additive and For the identification of premixtures, feed business Camelids Duddingtonia flagransNCIMB operators shall establish 30336: DNA based methods. Cervids operational procedures and For the enumeration of viable organisational measures to Equines chlamydospores of address potential risks Duddingtonia flagransNCIMB resulting from their use.

Calves of bovine - 1,4 × 106 3,0 × 106 30336 in the feed additive, Where those risks cannot be species premixtures and compound eliminated by such

feed: the method using yeast Piglets of porcine - 6,0 × 105 1,2 × 106 procedures and measures, mannitol agar (YMA) with species the additive and premixtures streptomycin and shall be used with personal Porcine species - 7,2 × 105 1,4 × 106 chloramphenicol and a most breathing and skin for fattening probable number (MPN) for protective equipment.

the enumeration. Sows of porcine - 8,8 × 105 1,7 × 106 species Rabbits - 5,3 × 105 1,1 × 106

(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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ELI:

http://data.europa.eu/eli/reg_impl/2026/534/oj EN OJ L,

12.3.2026