Kommisjonens gjennomføringsforordning (EU) 2025/2176 av 29. oktober 2025 om fornyet godkjenning av preparater av Pediococcus acidilactici NCIMB 30005, Lacticaseibacillus paracasei NCIMB 30151 og Lactiplantibacillus plantarum DSM 16627 som tilsetningsstoff i fôr til alle dyrearter og om oppheving av gjennomføringsforordning (EU) nr. 849/2014
Fornyet godkjenning av Pediococcus acidilactici, Lacticaseibacillus paracasei og Lactiplantibacillus plantarum som tilsetningsstoff i fôr til alle dyrearter
Kommisjonsforordning publisert i EU-tidende 30.10.2025
Tidligere
- Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 6.8.2025
Bakgrunn
(fra kommisjonsforordningen)
(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 preparations of Pediococcus acidilactici NCIMB 30005, Lacticaseibacillus paracasei NCIMB 30151 (previously taxonomically identified as Lactobacillus paracasei NCIMB 30151) and Lactiplantibacillus plantarum DSM 16627 (previously identified as Lactobacillus plantarum DSMZ 16627) were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) No 849/2014.
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, three applications were submitted for the renewal of the authorisation of the preparations of Pediococcus acidilactici NCIMB 30005, Lacticaseibacillus paracasei NCIMB 30151 and Lactiplantibacillus plantarum DSM 16627 as feed additives for all animal species, requesting the additives to be classified in the additive category ‘technological additives’ and in the functional group ‘silage additives’. Those applications were 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 opinions of 15 October 2024, 26 November 2024 and 28 January 2025 that the preparations of Pediococcus acidilactici NCIMB 30005, Lacticaseibacillus paracasei NCIMB 30151 and Lactiplantibacillus plantarum DSM 16627 remain safe for the target species, the consumers and the environment, under the conditions of use currently authorised. It also concluded that the additives should be considered as potential skin and respiratory sensitizers and that any dermal and respiratory exposure is considered a risk. In the absence of data, the Authority could not conclude on their eye irritation potential. The Authority further concluded that there is no need for assessing the efficacy of the additives as the applications for renewal of their authorisation do not include a proposal for amending or supplementing the conditions of the original authorisation which would have an impact on the efficacy of the additives. It also indicated that values found for citrinin are high and deserve attention and monitoring during the production process.
(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 preparations of Pediococcus acidilactici NCIMB 30005, Lacticaseibacillus paracasei NCIMB 30151 and Lactiplantibacillus plantarum DSM 16627 as feed additives 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, an evaluation report of the Reference Laboratory is therefore not required.
(6) In view of the above, the Commission considers that the preparations of Pediococcus acidilactici NCIMB 30005, Lacticaseibacillus paracasei NCIMB 30151 and Lactiplantibacillus plantarum DSM 16627 satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of those additives 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 additives. 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 preparations of Pediococcus acidilactici NCIMB 30005, Lacticaseibacillus paracasei NCIMB 30151 and Lactiplantibacillus plantarum DSM 16627 as feed additives, Implementing Regulation (EU) No 849/2014 should be repealed.
(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparations of Pediococcus acidilactici NCIMB 30005, Lacticaseibacillus paracasei NCIMB 30151 and Lactiplantibacillus plantarum DSM 16627, 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,