Kommisjonens gjennomføringsforordning (EU) 2024/763 av 29. februar 2024 om fornyet godkjenning av preparater av Lactiplantibacillus plantarum NCIMB 30083 og Lactiplantibacillus plantarum NCIMB 30084 som et tilsetningsstoff i fôr for alle dyrearter og om oppheving av gjennomføringsforordning (EU) nr. 308/2013
Fornyet godkjenning av preparater av L. plantarum mfl. som fôrtilsetningsstoff for alle dyrearter
Kommisjonsforordning publisert i EU-tidende 1.3.2024
Nærmere omtale
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) Preparations of Lactiplantibacillus plantarum NCIMB 30083 (previously taxonomically identified as Lactobacillus plantarum NCIMB 30083) and Lactiplantibacillus plantarum NCIMB 30084 (previously taxonomically identified as Lactobacillus plantarum NCIMB 30084) were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) No 308/2013 (2).
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, applications were submitted for the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum NCIMB 30083 and Lactiplantibacillus plantarum NCIMB 30084 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 4 July 2023 (3) that the preparations of Lactiplantibacillus plantarum NCIMB 30083 and Lactiplantibacillus plantarum NCIMB 30084 remain safe for all animal species, the consumers and the environment under the conditions of use currently authorised. It also concluded that the additives should be considered as respiratory sensitisers and that no conclusions could be drawn on the skin sensitisation, and skin and eye irritancy potential of the additives. It also indicated that there is no need for assessing the efficacy of the additives as the applications for renewal of the authorisation do not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additives.
(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessments carried out regarding the method of analysis of the preparations of Lactiplantibacillus plantarum NCIMB 30083 and Lactiplantibacillus plantarum NCIMB 30084 as feed additives in the context of the previous authorisation are valid and applicable for the current applications. In accordance with Article 5(4), point (c) of Commission Regulation (EC) No 378/2005 (4), evaluation reports of the Reference Laboratory are therefore not required.
(6) In view of the above, the Commission considers that the preparations of Lactiplantibacillus plantarum NCIMB 30083 and Lactiplantibacillus plantarum NCIMB 30084 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 Lactiplantibacillus plantarum NCIMB 30083 and Lactiplantibacillus plantarum NCIMB 30084 as feed additives, Implementing Regulation (EU) No 308/2013 should be repealed.
(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of preparations of Lactiplantibacillus plantarum NCIMB 30083 and Lactiplantibacillus plantarum NCIMB 30084, 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,