(Utkast) Kommisjonens gjennomføringsforordning (EU) .../... om fornyet godkjenning av et preparat av Pediococcus pentosaceus DSM 14021 som tilsetningsstoff i fôr til alle dyrearter og om oppheving av gjennomføringsforordning (EU) nr. 84/2014
Fornyet godkjenning av et preparat av Pediococcus pentosaceus DSM 14021 som tilsetningsstoff i fôr til alle dyrearter
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 17.1.2025
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 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.
(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 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, 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,