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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 nutritionnote, 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 Lactiplantibacillus plantarum CECT 4528 (previously taxonomically identified as Lactobacillus plantarum CECT 4528) was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 399/2014note.
(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 Lactiplantibacillus plantarum CECT 4528 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 28 January 2025note that the preparation of Lactiplantibacillus plantarum CECT 4528 remains safe for all animal species, the consumers and the environment. The Authority also concluded that the additive is not irritant to eyes, but it should be considered as a skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. It further indicated that there is no need for assessing the efficacy of the additive as the application for the renewal of its authorisation 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 Lactiplantibacillus plantarum CECT 4528 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 378/2005note, an evaluation report of the Reference Laboratory is therefore not required.
(6)In view of the above, the Commission considers that the preparation of Lactiplantibacillus plantarum CECT 4528 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 Lactiplantibacillus plantarum CECT 4528 as a feed additive, Implementing Regulation (EU) No 399/2014 should be repealed.
(8)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of Lactiplantibacillus plantarum CECT 4528, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.
(9)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 399/2014#
Implementing Regulation (EU) No 399/2014 is repealed.
Article 3Transitional measures#
The preparation specified in the Annex and feed containing it, which are produced and labelled before 19 November 2026 in accordance with the rules applicable 19 November 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.
Article 4Entry 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 | ||||||||
| 1k20746 | Lactiplantibacillus plantarumCECT 4528 | Additive compositionPreparation of Lactiplantibacillus plantarum CECT 4528 containing a minimum of 2,5 × 1011 CFU/g additive.Solid form—————————Characterisation of the active substanceViable cells of Lactiplantibacillus plantarum CECT 4528—————————Analytical methodnoteIdentification of Lactiplantibacillus plantarum CECT 4528 in the feed additive:Pulsed Field Gel Electrophoresis (PFGE) - CEN/TS 17697 or DNA sequencing methods.Enumeration of Lactiplantibacillus plantarum CECT 4528 in the feed additive:Spread plate (or pour plate) method on MRS agar (EN 15787) | 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 × 109 CFU/kg fresh 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 and breathing protective equipment. | 19 November 2035 |
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