(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. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2) The substance cajeput essential oil derived from Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L. was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. This substance was subsequently entered in the Register of Feed Additives as an existing product, in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003.

(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of cajeput essential oil derived from Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L. as a feed additive for all animal species, requesting the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4) The applicant requested the additive to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water for drinking. Therefore, the use of this additive in water for drinking should not be allowed.

(5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 March 2024 (3) that cajeput essential oil derived from Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L. is safe for all animal species at certain maximum concentrations further specified for each species. Furthermore, it concluded that no concerns for consumers were identified following the use of cajeput essential oil derived from Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L., under the proposed conditions, and that its use is not expected to pose a risk to the environment under the proposed conditions. The Authority concluded that cajeput essential oil derived from Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L. should be considered as an irritant to skin and eyes, and as a dermal and respiratory sensitiser. The Authority further concluded that since cajeput essential oil derived from Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L. is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6) In view of the above, the Commission considers that cajeput essential oil derived from Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L. satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation. 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.

(7) The Commission considers that safety reasons do not require the setting of maximum levels for cajeput essential oil derived from Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L. In order to allow better control, the recommended maximum content should be indicated on the label of the feed additive. Where the recommended maximum content is exceeded, certain information should be indicated on the label of the premixtures concerned.

(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substance concerned, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from 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,