Official Gazette Notification Text
Official TranscriptOfficial Journal EN of the European Union L series 2025/1465 23.7.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1465 of 22 July 2025 concerning the authorisation of a preparation of Enterococcus faeciumATCC 53519 and a preparation of Enterococcus faeciumATCC 55593 as feed additives for all animal species (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the...
Official Journal EN of the European Union L series 2025/1465 23.7.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1465 of 22 July 2025 concerning the authorisation of a preparation of Enterococcus faeciumATCC 53519 and a preparation of Enterococcus faeciumATCC 55593 as feed additives for all animal species (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. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC(2). Article 10(7) of Regulation (EC) No 1831/2003 sets out specific provisions for the placing on the market and use of products used in the Union as silage additives.
(2) In accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003, the preparations of Enterococcus faecium ATCC 53519 and Enterococcus faeciumATCC 55593 were entered in the Register of Feed Additives under the names Enterococcus faecium SF202-DSM 4788-ATCC 53519 and Enterococcus faecium SF301-DSM 4789-ATCC 55593 respectively, as existing products belonging to the functional group of silage additives, for all animal species.
(3) In accordance with Article 10(7) of Regulation (EC) No 1831/2003, in conjunction with Article 7 and Article 10(2) thereof, applications were submitted for the authorisation of the preparations of Enterococcus faecium ATCC 53519 and Enterococcus faecium ATCC 55593 as feed additives for all animal species, requesting those additives to be classified in the category ‘technological additives’ and in the functional group ‘silage additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 1 October 2013(3), that the use of Enterococcus faeciumATCC 53519 and Enterococcus faeciumATCC 55593 is safe for all animal species, consumers and the environment. It also concluded that in the absence of evidence, these additives should be regarded as skin and eye irritants and potential skin sensitisers. Given the proteinaceous nature of the active agents, the Authority considers it prudent to treat these additives as respiratory sensitisers. Also, due to the high dusting potential of most of the preparations tested the Authority concluded that there is a need to take measures to minimise inhalation exposure of workers. The Authority could not conclude on the efficacy of these additives. In the subsequent opinions of 27 September 2022(4), 4 July 2023(5) and 15 October 2024(6) the Authority reached the conclusion that the use of Enterococcus faecium ATCC 53519 and Enterococcus faecium ATCC 55593 in all types of fresh plant materials has the potential to be efficacious in improving the nutrient preservation of silage at the proposed conditions of use.
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1, ELI: http://data.europa.eu/eli/dir/1970/524/oj).
(3) EFSA Journal 2013; 11 (10):3363; https://doi.org/10.2903/j.efsa.2013.3363.
(4) EFSA Journal 2022; 20(10):7603; https://doi.org/10.2903/j.efsa.2022.7603.
(5) EFSA Journal 2023;21(7):8166; https://doi.org/10.2903/j.efsa.2023.8166.
(6) EFSA Journal, 22(11), e9071. https://doi.org/10.2903/j.efsa.2024.9071.
ELI: http://data.europa.eu/eli/reg_impl/2025/1465/oj 1/4EN OJ L, 23.7.2025
(5) In view of the above, the Commission considers that the preparations of Enterococcus faecium ATCC 53519 and Enterococcus faeciumATCC 55593 satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003.
Accordingly, the use of those preparations should be authorised. 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.
(6) 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 preparations specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.
Article 2 Transitional measures The feed additives Enterococcus faecium SF202-DSM 4788-ATCC 53519 and Enterococcus faecium SF301-DSM 4789-ATCC 55593 and feed containing them, which are produced and labelled before 12 August 2026 in accordance with the rules applicable before 12 August 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.
Article 3 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, 22 July 2025.
For the Commission The President Ursula VON DER LEYEN 2/4 ELI: http://data.europa.eu/eli/reg_impl/2025/1465/ojANNEX Identifica Minimum Maximum tion Species or content content End of period Composition, chemical formula, Maximum number of Additive category Other provisions of description, analytical method age the feed of animal authorisation CFU/kg of fresh material additive
Category: technological additives. Functional group: silage additives 1k20603 Enterococcus faecium Additive composition All - - - 1. In the directions for use of 12 August ATCC 53519 Preparation of Enterococcus faecium animal the additive and premixtures, 2035 ATCC 53519 containing a minimum species the storage conditions shall of 1 × 1010CFU/g additive be indicated.
Solid form
2. Minimum dose of the —————————— additive when it is not used in Characterisation of the active substance combination with other micro-organisms as silage Viable cells of Enterococcus faecium
additives: 1 × 107CFU/kg ATCC 53519 fresh plant material. —————————— Analytical method(1) 3. For users of the additive and premixtures, feed business Identification of Enterococcus faecium operators shall establish ATCC 53519:
operational procedures and — Pulsed-Field Gel Electrophoresis organisational measures to
(PFGE) – CEN/TS 17697 or DNA address potential risks sequencing methods resulting from their use.
Enumeration of Enterococcus faecium Where those risks cannot be ATCC 53519: eliminated by such procedures and measures, — Spread plate (or pour plate) the additive and premixtures method on bile esculin azide agar shall be used with personal or on Slanetz and Bartley agar (EN skin, eye and breathing
15788) protective equipment.
(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/2025/1465/oj 3/4 OJ L,
23.7.2025 ENIdentifica Minimum Maximum tion Species or content content Composition, chemical formula, Maximum End of period number of Additive category Other provisions description, analytical method age of authorisation the feed of animal CFU/kg of fresh material additive
Category: technological additives. Functional group: silage additives 1k20604 Enterococcus faecium Additive composition All - - - 1. In the directions for use of 12 August ATCC 55593 Preparation of Enterococcus faecium animal the additive and premixtures, 2035 ATCC 55593 containing a minimum species the storage conditions shall of 1 × 1010CFU/g additive be indicated.
Solid form
2. Minimum dose of the —————————— additive when it is not used in combination with other Characterisation of the active substance micro-organisms as silage
Viable cells of Enterococcus faecium additives: 5 × 106CFU/kg ATCC 55593 fresh plant material. ——————————
3. For users of the additive and Analytical method(1) premixtures, feed business Identification of Enterococcus faecium operators shall establish ATCC 55593: operational procedures and organisational measures to — DNA sequencing methods or address potential risks Pulsed Field Gel Electrophoresis resulting from their use.
(PFGE) (CEN/TS 17697) Where those risks cannot be Enumeration of Enterococcus faecium eliminated by such ATCC 55593: procedures and measures, — Spread plate (or pour plate) the additive and premixtures method on bile esculin azide agar shall be used with personal or on Slanetz and Bartley agar (EN skin, eye and breathing
15788) protective equipment.
(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.
4/4
ELI:
http://data.europa.eu/eli/reg_impl/2025/1465/oj EN OJ L,
23.7.2025