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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 nutritionnote, 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 2021note, 31 January 2023note and 26 November 2024note 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 1Authorisation#
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 2Entry 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.
| 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 compositionPreparation of the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 containing a minimum of 5 × 107 PFUnote/ml additive(1:1:1:1 ratio).Liquid form.Characterisation of the active substanceLytic bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 infecting Salmonella enterica ser. Gallinarum B/00111.Analytical methodnoteIdentification: 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 429/2008note.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 |
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