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)
Date: 2026-03-11
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: cattle, cervidae, equidae, fodder, food additive, goat, market approval, rabbit, sheep, swine








L_202600534EN.000101.fmx.xml












Official Journal of the European Union


EN
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 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)
(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 flagrans NCIMB 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.












(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 flagrans NCIMB 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 flagrans NCIMB 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 × 104 chlamydospores/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 flagrans NCIMB 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 flagrans NCIMB 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.


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
            





(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 flagrans NCIMB 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.

(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 Journal 2017;15(10):5021, https://doi.org/10.2903/j.efsa.2017.5021.




ANNEX














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




Number of 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 Animal Health Products Pty Ltd, represented by SynTech Regulatory Europe GmbH



Duddingtonia flagrans NCIMB 30336



Additive composition

Preparation of Duddingtonia flagrans NCIMB 30336, containing a minimum of 5 × 105 chlamydospores/g additive.
Solid form.

Characterisation of the active substance

Viable chlamydospores of Duddingtonia flagrans NCIMB 30336

Analytical methods
 (1)

For the identification of Duddingtonia flagrans NCIMB 30336: DNA based methods.
For the enumeration of viable chlamydospores of Duddingtonia flagrans NCIMB 30336 in the feed additive, premixtures and compound feed: the method using yeast mannitol agar (YMA) with streptomycin and chloramphenicol and a most probable number (MPN) for the enumeration.


Cows for reproduction and bulls
Cows for reproduction and bulls of minor bovine species


-


8,5 × 105



8,5 × 106









1.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










2.


The additive shall only be used in feed for grazing animals.










3.


The additive shall be used at the minimum dose of 3 × 104 chlamydospores/kg bodyweight and day.










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 April 2036




Bovines for fattening
Ovines other than dairy sheep
Caprines other than dairy goats
Camelids
Cervids
Equines


-


1,3 × 106



2,6 × 106





Calves of bovine species


-


1,4 × 106



3,0 × 106





Piglets of porcine species


-


6,0 × 105



1,2 × 106





Porcine species for fattening


-


7,2 × 105



1,4 × 106





Sows of porcine species


-


8,8 × 105



1,7 × 106





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.



ELI: http://data.europa.eu/eli/reg_impl/2026/534/oj
ISSN 1977-0677 (electronic edition)