Commission 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
Date: 2026-01-15
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, food additive, market approval, swine








L_202600103EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2026/103


16.1.2026







            COMMISSION 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
(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 and renewing such an authorisation.












(2)


A preparation of Enterococcus lactis (originally assigned to the Enterococcus faecium species) DSM 7134, was authorised for a period of 10 years as a feed additive for sows by Commission Implementing Regulation (EU) No 1083/2014 (2).












(3)


In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of Enterococcus lactis DSM 7134 as a feed additive for sows, requesting the additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.












(4)


The European Food Safety Authority (‘the Authority’) concluded in its opinion of 19 March 2025 (3) that the preparation of Enterococcus lactis DSM 7134 remains safe for sows, as well as for the consumers and the environment under the conditions of use currently authorised. It also concluded that the preparation of Enterococcus lactis DSM 7134 in its powder form is not irritant to skin and eyes but no such conclusion is possible for the granulated form of the additive. Both forms of the additive should be considered skin and respiratory sensitisers and any exposure through skin and respiratory tract is considered a risk. The Authority also indicated that there is no need for assessing the efficacy of the preparation of Enterococcus lactis DSM 7134, as the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisations which would have an impact on the efficacy of the additive. The Authority did not consider that there is a need for specific requirements of post-market monitoring.












(5)


The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of the preparation of Enterococcus lactis DSM 7134 as a feed additive in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005 (4), an evaluation report of the Reference Laboratory is therefore not required.












(6)


In view of the above, the Commission considers that the preparation of Enterococcus lactis DSM 7134 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed. 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. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.












(7)


As a consequence of the renewal of the authorisation of the preparation of Enterococcus lactis DSM 7134 as a feed additive, Implementing Regulation (EU) No 1083/2014 should be repealed.












(8)


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

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 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, 15 January 2026.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2)  Commission Implementing Regulation (EU) No 1083/2014 of 15 October 2014 concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 (Bonvital) as a feed additive for sows (OJ L 298, 16.10.2014, p. 5, ELI: http://data.europa.eu/eli/reg_impl/2014/1083/oj).

(3)  
            EFSA Journal 2025; 23:e9353. https://doi.org/10.2903/j.efsa.2025.9353.

(4)  Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 059 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/2005/378/oj).




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




CFU/kg of complete feed with a moisture content of 12 %





Category: zootechnical additives. Functional group: gut flora stabilisers





4b1841


Lactosan GmbH&Co.KG



Enterococcus lactis DSM 7134



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
 (1)

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






(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/2026/103/oj
ISSN 1977-0677 (electronic edition)