Commission Implementing Regulation (EU) 2026/549 of 13 March 2026 concerning the renewal of the authorisation of a preparation of the bacterial strain DSM 11798 of the Eggerthellaceae family as a feed additive for pigs, poultry and ornamental birds and repealing Implementing Regulations (EU) No 1016/2013 and (EU) 2017/930
Date: 2026-03-13
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, bird, food additive, market approval, poultry, swine




L_202600549EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2026/549


16.3.2026







            COMMISSION IMPLEMENTING REGULATION (EU) 2026/549
of 13 March 2026
         
concerning the renewal of the authorisation of a preparation of the bacterial strain DSM 11798 of the Eggerthellaceae family as a feed additive for pigs, poultry and ornamental birds and repealing Implementing Regulations (EU) No 1016/2013 and (EU) 2017/930
(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 and renewing such an authorisation.












(2)


A preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family was authorised for a period of 10 years as a feed additive for pigs by Commission Implementing Regulation (EU) No 1016/2013 (2) and for all avian species by Commission Implementing Regulation (EU) 2017/930 (3).












(3)


In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of the bacterial strain DSM 11798 of the Eggerthellaceae family (previously taxonomically identified as belonging to the Coriobacteriaceae family) as a feed additive for pigs and all avian species, requesting the additive to be classified in the additive category ‘technological additives’ and in the functional group ‘substances for the reduction of the contamination of feed by mycotoxins’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.












(4)


The European Food Safety Authority (‘the Authority’) concluded in its opinion of 20 March 2025 (4) that the preparation of the bacterial strain DSM 11798 of the Eggerthellaceae family remains safe for piglets, pigs for fattening and all avian species, consumers and the environment under the approved terms of the authorisation. It also concluded that the preparation of the bacterial strain DSM 11798 of the Eggerthellaceae family is not irritant to skin or eyes but it should be considered a potential skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The Authority stated that the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, it concluded that there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.












(5)


The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of the preparation of the bacterial strain DSM 11798 of the Eggerthellaceae family as a feed additive in the context of the previous authorisations are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005 (5) an evaluation report of the Reference Laboratory is therefore not required.












(6)


In view of the above, the Commission considers that the preparation of the bacterial strain DSM 11798 of the Eggerthellaceae family satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.












(7)


As a consequence of the renewal of the authorisation of the preparation of the bacterial strain DSM 11798 of the Eggerthellaceae family as a feed additive, Implementing Regulations (EU) No 1016/2013 and (EU) 2017/930 should be repealed.












(8)


Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of the bacterial strain DSM 11798 of the Eggerthellaceae family, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.












(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

Renewal of the authorisation

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘substances for the reduction of the contamination of feed by mycotoxins’, is renewed subject to the conditions laid down in that Annex.


Article 2

Repeal

Implementing Regulations (EU) No 1016/2013 and (EU) 2017/930 are repealed.


Article 3

Transitional measures


1.   The preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family, as authorised by Implementing Regulations (EU) No 1016/2013 and (EU) 2017/930 and premixtures containing that additive, which are intended for pigs and all avian species and which are produced and labelled before 5 October 2026 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.


2.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for pigs and all avian species 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 if they are intended for food-producing animals.


3.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for pigs and all avian species and which are produced and labelled before 5 April 2028 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 if they are intended for non-food producing animals.



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
            





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

(2)  Commission Implementing Regulation (EU) No 1016/2013 of 23 October 2013 concerning the authorisation of a preparation of a micro-organism strain DSM 11798 of the Coriobacteriaceae family as a feed additive for pigs (OJ L 282, 24.10.2013, p. 36, ELI: http://data.europa.eu/eli/reg_impl/2013/1016/oj).

(3)  Commission Implementing Regulation (EU) 2017/930 of 31 May 2017 concerning the authorisation of a preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family as a feed additive for all avian species and amending Implementing Regulation (EU) No 1016/2013 (OJ L 141, 1.6.2017, p. 6, ELI: http://data.europa.eu/eli/reg_impl/2017/930/oj).

(4)  
            EFSA Journal 2025;23(4):e9360, https://doi.org/10.2903/j.efsa.2025.9360.

(5)  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).




ANNEX













Identification number of the additive


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




CFU/kg of complete feed with 12 % moisture content





Category: technological additives. Functional group: substances for the reduction of the contamination of feed by mycotoxins: trichothecenes





1m01


Bacterial strain DSM 11798 of the Eggerthellaceae family



Additive composition

Preparation of the bacterial strain DSM 11798 of the Eggerthellaceae family containing a minimum of 5 × 109 CFU/g of additive.
Solid form.

Characterisation of the active substance

Viable cells of the bacterial strain DSM 11798 of the Eggerthellaceae family

Analytical method
 (1)

Enumeration of the bacterial strain DSM 11798 of the Eggerthellaceae family:






—


Pour plate method using VM agar supplemented with Oxyrase.




Identification of the bacterial strain DSM 11798 of the Eggerthellaceae family:






—


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






Pigs
Poultry
Ornamental birds


—


1,7 × 108



—








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 which is already compliant with the rules established for mycotoxins in Union law on undesirable substances in animal feed.










3.


The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: narasin/nicarbazin, salinomycin sodium, monensin sodium, robenidine hydrochloride, diclazuril, narasin, or 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 skin and breathing protective equipment.






5 April 2036






(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/2026/549/oj
ISSN 1977-0677 (electronic edition)