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

(2) The substances juniper essential oil and juniper tincture from Juniperus communis L. were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of Feed Additives as existing products belonging to the category ‘sensory additives’ and to the functional group ‘flavouring compounds’, 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 juniper essential oil and juniper tincture from Juniperus communis L. as feed additives for all animal species, requesting the additives to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. 

(4) The applicant requested the additives 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 22 March 2023 that, under the proposed conditions of use, juniper tincture from Juniperus communis L. is safe for all animal species and consumers. The Authority also concluded that juniper essential oil from Juniperus communis L. is safe for all animal species and consumers. at certain maximum concentrations further specified for each species. It also found that the use of juniper oil and juniper tincture from Juniperus communis L. in animal feed, under the proposed conditions, is not expected to pose a risk to the environment. It concluded that juniper essential oil and juniper tincture from Juniperus communis L. should be considered as irritants to skin and eyes, and as skin and respiratory sensitisers. The Authority further concluded that since the berries of Juniperus communis L. and their preparations are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary. The Authority 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 juniper essential oil and juniper tincture from Juniperus communis L. satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of those substances should be authorised. 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 contents for juniper essential oil and juniper tincture from Juniperus communis L. In order to allow better control, the recommended maximum content should be indicated on the label of the feed additives. 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 juniper essential oil and juniper tincture from Juniperus communis L., 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,