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.)

• CELEX: Implementing Regulation (EU) 2025/1390
• Articles: 3

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.

Schedules & Appendices

ANNEX

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 × 10 7 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 × 10 6

—

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 × 10 6 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 ).