LegalizeCommission Implementing Regulation (EU) 2026/103 of 15 January 2026 concerning the renewal of the authorisation of a preparation of Enterococcus lactis DSM 7134 as a feed additive for sows (holder of authorisation: Lactosan GmbH&Co.KG) and repealing Implementing Regulation (EU) No 1083/2014
Article 1
Renewal of the authorisation
The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed, subject to the conditions laid down in that Annex.
Article 2
Repeal
Implementing Regulation (EU) No 1083/2014 is repealed.
Article 2a
Transitional measures
The feed additive Enterococcus faecium DSM 7134, as authorised by Implementing Regulation (EU) No 1083/2014, and premixtures containing that additive, which are intended for sows, and which are produced and labelled before 7 January 2027 in accordance with the rules applicable before 7 July 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.
Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for sows, and which are produced and labelled before 7 July 2027 in accordance with the rules applicable before 7 July 2026 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.
ANNEX
| Identification number of the feed additive | Name of the holder of authorisation | Name of the 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Identification number of the feed additive | Name of the holder of authorisation | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | CFU/kg of complete feed with a moisture content of 12 % | CFU/kg of complete feed with a moisture content of 12 % | Other provisions | End of period of authorisation | |||||||
| Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | |||||||
| 4b1841 | Name of the holder of authorisation | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Lactosan GmbH&Co.KG | Enterococcus lactis DSM 7134 | Other provisions | End of period of authorisation | Additive composition Preparation of Enterococcus lactis DSM 7134 containing a minimum of: powder: 1 × 1010 CFU/g of additive granulated (microencapsulated): 1 × 1010 CFU/g of additive Characterisation of the active substance Viable cells of Enterococcus lactis DSM 7134. Analytical method [^E0001] Enumeration: spread plate (or pour plate) method on bile esculin azide agar or on Slanetz and Bartley agar (EN 15788) Identification: Pulsed-Field Gel Electrophoresis (PFGE) CEN/TS 17697 or DNA sequencing methods | Sows | - | 5 × 108 | 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 2. 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 eye, breathing and skin protective equipment. | 5 February 2036 |
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.
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