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.)

Official Journal EN of the European Union 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 SalmonellaEnteritidis 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.

(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.

ELI: http://data.europa.eu/eli/reg_impl/2025/1390/oj 1/4EN OJ L, 16.7.2025

(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 2/4 ELI: http://data.europa.eu/eli/reg_impl/2025/1390/ojANNEX Identifica­ Minimum Maximum Species tion Name of the Composition, chemical content content or Maxi­ End of period of number of holder of Additive formula, description, Other provisions category mum age authorisation the feed authorisation analytical method of animal PFU/l of water for drinking additive

Category: zootechnical additives. Functional group: other zootechnical additives (reduction of the environmental contamination by poultry with SalmonellaEnteritidis) 4d29 Proteon Bacteriophages Additive composition Poultry — 6 × 106 — 1. In the directions for use of the 5 August Pharmaceuti­ PCM F/00069, additive, the storage conditions and 2035 Preparation of the cals S.A. PCM F/00070, the stability in water for drinking shall bacteriophages PCM PCM F/00071 be indicated.

F/00069, PCM and PCM F/00070, PCM F/00071 F/00097 2. The additive shall only be used in and PCM F/00097 water for drinking. containing a minimum of 5 × 107PFU(1)/ml

3. The additive shall be used ensuring a additive

minimum dose of: 2 × 106PFU/ (1:1:1:1 ratio). bird/day.

Liquid form.

4. On the label of the additive the

following shall be indicated:

Characterisation of the ‘The additive 4d29 cannot be active substance considered as a replacement for the Lytic bacteriophages standard hygiene farming PCM F/00069, PCM conditions.’ F/00070, PCM F/00071 and PCM F/00097 5. A post-market monitoring infecting Salmonella programme addressing in particular entericaser. Gallinarum the potential selection and spread of B/00111. resistant variants of Salmonellato the bacteriophages PCM F/00069, PCM Analytical method(2) F/00070, PCM F/00071 and PCM F/00097, and the potential effect of

Identification: phage- bacteriophages on the horizontal specific PCR method. spread of antimicrobial resistance Enumeration in the genes in Salmonellaand in the gut feed additive and water flora, shall be planned and executed

for drinking: double by the holder of authorisation, in agar overlay plaque accordance with Commission assay. Regulation (EC) No 429/2008(3).

ELI:

http://data.europa.eu/eli/reg_impl/2025/1390/oj 3/4 OJ L,

16.7.2025 ENIdentifica­ Minimum Maximum Species tion Name of the Composition, chemical content content or Maxi­ End of period of number of holder of Additive formula, description, Other provisions category mum age authorisation the feed authorisation analytical method of animal PFU/l of water for drinking additive

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.

(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).

4/4

ELI:

http://data.europa.eu/eli/reg_impl/2025/1390/oj EN OJ L,

16.7.2025