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

(2) The substance coriander essential oil from Coriandrum sativum L. was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That substance was subsequently entered in the Register of Feed Additives as an existing product 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 coriander essential oil from Coriandrum sativum 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’. 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 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 28 September 2023 that coriander essential oil from Coriandrum sativum L. is safe for all animal species at certain maximum concentrations further specified for each species. Furthermore, it concluded that coriander essential oil from Coriandrum sativum L.is safe for consumers and for the environment at the proposed use level in feed. It also concluded that coriander essential oil from Coriandrum sativum L. should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. The Authority further concluded that since the fruit of Coriandrum sativum L. and its oil 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 for the essential oil under assessment. 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 coriander essential oil from Coriandrum sativum L. satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised. The Commission considers that safety reasons do not require the setting of maximum contents for coriander essential oil from Coriandrum sativum L. In order to allow better control, a recommended maximum content should be indicated on the label of the feed additives. Where such contents are exceeded, certain information should be indicated on the label of the premixtures concerned. 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) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of coriander essential oil from Coriandrum sativum 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. 

(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,