(Utkast) Kommisjonens gjennomføringsforordning (EU) .../... om endring og retting av gjennomføringsforordning (EU) 2019/913 og retting av gjennomføringsforordning (EU) 2022/1471 om godkjenning av lantankarbonatoktahydrat, henholdsvis med identifikasjonsnummer 4d1 og 4d23, som tilsetningsstoffer i fôr for katter
Godkjenning av lantankarbonatoktahydrat som tilsetningsstoff i fôr til katter: endringsbestemmelser
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 12.3.2025
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 such an authorisation.
(2) The authorisation of lanthanum carbonate octahydrate was renewed for 10 years as a feed additive for cats, with identification number 4d1, by Commission Implementing Regulation (EU) 2019/9132 (holder of authorisation: Bayer HealthCare AG). Lanthanum carbonate octahydrate was also authorised for 10 years as a feed additive for cats, with identification number 4d23, by Commission Implementing Regulation (EU) 2022/14713 (holder of authorisation: Porus GmbH). Both additives were erroneously referred to as a preparation in the Annexes to those Implementing Regulations. In addition, the conditions of use in the Annexes to those Implementing Regulations do not properly reflect the conclusion of the European Food Safety Authority (‘the Authority’) in its opinions of 27 September 20074 and 27 January 20225 that lanthanum carbonate octahydrate is safe and efficacious for adult cats.
(3) Implementing Regulations (EU) 2019/913 and (EU) 2022/1471 should therefore be corrected accordingly.
(4) In addition, Bayer HealthCare AG, the holder of the authorisation of lanthanum carbonate octahydrate as a feed additive for cats, with identification number 4d1, has submitted an application to the Commission in accordance with Article 13(3) of Regulation (EC) No 1831/2003, proposing to change the name of the holder of the authorisation for that feed additive to Elanco GmbH.
(5) The proposed change of the terms of the authorisation concerning the name of the holder of the authorisation of lanthanum carbonate octahydrate as a feed additive for cats, with identification number 4d1, is purely administrative in nature and does not entail a new assessment. The Authority was informed of the application.
(6) To allow Elanco GmbH to exploit its marketing rights in accordance with Article 9(6) of Regulation (EC) No 1831/2003, it is necessary to change the terms of the authorisation concerned by indicating its name as the holder of the authorisation for lanthanum carbonate octahydrate as a feed additive for cats, with identification number 4d1.
(7) Implementing Regulation (EU) 2019/913 should therefore be amended accordingly.
(8) Since safety reasons do not require the immediate application of the modifications to the conditions of the authorisations of lanthanum carbonate octahydrate for cats, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the correction of Implementing Regulations (EU) 2019/913 and (EU) 2022/1471 and the amendment to Implementing Regulation (EU) 2019/913.
(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,