Commission Implementing Regulation (EU) 2025/1390 of 15 July 2025 concerning the authorisation of a preparation of the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 as a feed additive for poultry (holder of authorisation: Proteon Pharmaceuticals S.A.)
Date: 2025-07-15
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, food additive, market approval, poultry








L_202501390EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/1390


16.7.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/1390
of 15 July 2025
         
concerning the authorisation of a preparation of the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 as a feed additive for poultry (holder of authorisation: Proteon Pharmaceuticals S.A.)
(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 the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 as a feed additive for use in complementary feed and in water for drinking. 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 a preparation of the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 as a feed additive for all avian species, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘other zootechnical additives’.












(4)


The European Food Safety Authority (‘the Authority’) concluded in its opinions of 17 March 2021 (2), 31 January 2023 (3) and 26 November 2024 (4) that, under the proposed conditions of use, the preparation of the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 (‘the preparation’) is safe for all avian species, consumers and the environment. It also concluded that the preparation is not a skin or eye irritant but should be considered a potential skin and respiratory sensitiser, while inhalation and dermal exposure is considered a risk. The Authority further concluded that the preparation has the potential to reduce the environmental contamination with Salmonella Enteritidis when used in water for drinking or liquid complementary feed for all poultry species. It considered that there is a need for specific requirements of post-market monitoring to address the potential selection and spread of resistant variants of Salmonella to the preparation. The Authority also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.












(5)


On 7 February 2025, the applicant withdrew the application for the authorisation of the preparation of the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 for ornamental birds. Additionally, on 14 April 2025, the applicant withdrew the application for the authorisation of that preparation for use in complementary feed.












(6)


In view of the above, the Commission considers that the preparation satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003, when used in water for drinking for all poultry species. Accordingly, the use of that preparation should be authorised. It is appropriate to provide for post-market monitoring to address the potential selection and spread of resistant variants of Salmonella to the preparation. In addition, the Commission considers that the label of the additive should indicate that the additive cannot be considered as a replacement for the standard hygiene farming conditions. Finally, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.












(7)


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, 15 July 2025.


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)  
            EFSA Journal 2021;19(5):6534. https://doi.org/10.2903/j.efsa.2021.6534.

(3)  
            EFSA Journal 2023;21(3):7861. https://doi.org/10.2903/j.efsa.2023.7861.

(4)  
            EFSA Journal 2024;22:e9132. https://doi.org/10.2903/j.efsa.2024.9132.




ANNEX














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




PFU/l of water for drinking





Category: zootechnical additives. Functional group: other zootechnical additives (reduction of the environmental contamination by poultry with Salmonella Enteritidis)





4d29


Proteon Pharmaceuticals S.A.


Bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097



Additive composition

Preparation of the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 containing a minimum of 5 × 107 PFU (1)/ml additive
(1:1:1:1 ratio).
Liquid form.

Characterisation of the active substance

Lytic bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 infecting Salmonella enterica ser. Gallinarum B/00111.

Analytical method
 (2)

Identification: phage-specific PCR method.
Enumeration in the feed additive and water for drinking: double agar overlay plaque assay.


Poultry


—


6 × 106



—








1.


In the directions for use of the additive, the storage conditions and the stability in water for drinking shall be indicated.










2.


The additive shall only be used in water for drinking.










3.


The additive shall be used ensuring a minimum dose of: 2 × 106 PFU/bird/day.










4.


On the label of the additive the following shall be indicated:
‘The additive 4d29 cannot be considered as a replacement for the standard hygiene farming conditions.’










5.


A post-market monitoring programme addressing in particular the potential selection and spread of resistant variants of Salmonella to the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097, and the potential effect of bacteriophages on the horizontal spread of antimicrobial resistance genes in Salmonella and in the gut flora, shall be planned and executed by the holder of authorisation, in accordance with Commission Regulation (EC) No 429/2008 (3).










6.


For users of the additive, 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 shall be used with personal breathing and skin protective equipment.






5 August 2035






(1)  PFU: plaque-forming unit.

(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.

(3)  Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/429/oj).



ELI: http://data.europa.eu/eli/reg_impl/2025/1390/oj
ISSN 1977-0677 (electronic edition)