Commission Implementing Regulation (EU) 2025/159

Contents

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^note, 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 authorisation.

(2)The preparation of Pediococcus pentosaceus DSM 14021 was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 84/2014^note.

(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 Pediococcus pentosaceus DSM 14021 as a feed additive for all animal species, requesting the additive to be classified in the additive category ‘technological additives’ and in the functional group ‘silage additives’. 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 12 March 2024^note that the preparation of Pediococcus pentosaceus DSM 14021 remains safe for all target animal species, the consumers and the environment under the conditions of use currently authorised. It also concluded that the additive should be considered as a potential skin and respiratory sensitizer, that any exposure through skin and respiratory tract is considered a risk and it could not conclude on the eye irritation potential of the additive due to the lack of data. The Authority also indicated that there is no need for assessing the efficacy of the additive, as the application for renewal does not include a proposal for amending or supplementing the conditions of the original authorisation which would have an impact on the efficacy of the additive.

(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 Pediococcus pentosaceus DSM 14021 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^note, an evaluation report of the Reference Laboratory is therefore not required.

(6)In view of the above, the Commission considers that the preparation of Pediococcus pentosaceus DSM 14021 satisfies the conditions, as 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 Pediococcus pentosaceus DSM 14021 as a feed additive, Implementing Regulation (EU) No 84/2014 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 1Renewal of the authorisation#

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is renewed subject to the conditions laid down in that Annex.

Article 2Repeal of Implementing Regulation (EU) No 84/2014#

Implementing Regulation (EU) No 84/2014 is repealed.

Article 3Entry 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	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
1k1009	Pediococcus pentosaceus DSM 14021	Additive compositionPreparation of Pediococcus pentosaceus DSM 14021 containing a minimum of 1 × 10¹¹ CFU/g additiveSolid form-------------	All animal species	-	-	-	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. The additive shall only be used in easy and moderately difficult to ensile fresh material.3. Minimum dose of the additive, when it is not used in combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.4. 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.	19 February 2035
Characterisation of the active substanceViable cells of Pediococcus pentosaceus DSM 14021-------------
Analytical method^noteEnumeration in the feed additive of Pediococcus pentosaceus DSM 14021:Spread plate method on MRS agar (EN 15786).Identification of Pediococcus pentosaceus DSM 14021:Pulsed Field Gel Electrophoresis (PFGE) - CEN/TS 17697 or DNA sequencing methods.