Commission Implementing Regulation (EU) 2025/1465 of 22 July 2025 concerning the authorisation of a preparation of Enterococcus faecium ATCC 53519 and a preparation of Enterococcus faecium ATCC 55593 as feed additives for all animal species

• CELEX: Implementing Regulation (EU) 2025/1465
• Articles: 4

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.

Schedules & Appendices

ANNEX

ANNEX

Identification number of the feed additive

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

CFU/kg of fresh material

Category: technological additives. Functional group: silage additives

1k20603

Enterococcus faecium ATCC 53519

Additive composition

Preparation of Enterococcus faecium ATCC 53519 containing a minimum of 1 × 10 10 CFU/g additive

Solid form

——————————

Characterisation of the active substance

Viable cells of Enterococcus faecium ATCC 53519

——————————

Analytical method

( 1 )

Identification of Enterococcus faecium ATCC 53519:

—

Pulsed-Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods

Enumeration of Enterococcus faecium ATCC 53519:

—

Spread plate (or pour plate) method on bile esculin azide agar or on Slanetz and Bartley agar (EN 15788)

All animal species

-

-

-

1.

In the directions for use of the additive and premixtures, the storage conditions shall be indicated.

2.

Minimum dose of the additive when it is not used in combination with other micro-organisms as silage additives: 1 × 10 7 CFU/kg fresh plant material.

3.

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

12 August 2035

Identification number of the feed additive

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

CFU/kg of fresh material

Category: technological additives. Functional group: silage additives

1k20604

Enterococcus faecium ATCC 55593

Additive composition

Preparation of Enterococcus faecium ATCC 55593 containing a minimum of 1 × 10 10 CFU/g additive

Solid form

——————————

Characterisation of the active substance

Viable cells of Enterococcus faecium ATCC 55593

——————————

Analytical method

( 2 )

Identification of Enterococcus faecium ATCC 55593:

—

DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) (CEN/TS 17697)

Enumeration of Enterococcus faecium ATCC 55593:

—

Spread plate (or pour plate) method on bile esculin azide agar or on Slanetz and Bartley agar (EN 15788)

All animal species

-

-

-

1.

In the directions for use of the additive and premixtures, the storage conditions shall be indicated.

2.

Minimum dose of the additive when it is not used in combination with other micro-organisms as silage additives: 5 × 10 6 CFU/kg fresh plant material.

3.

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

12 August 2035

( 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 .

( 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 .