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

(2)

Isoeugenol, was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That product was subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) 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 re-evaluation of the isoeugenol as a feed additive for all animal species except for poultry, ruminants producing milk for human consumption and fish. The applicant requested that additive to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 14 December 2011 (3) that, under the proposed conditions of use in feed, isoeugenol does not have adverse effects on animal health, human health or the environment. Isoeugenol should not be allowed for those categories of mammal species intended for the production of milk for human consumption. The Authority further concluded that the function of isoeugenol in feed is similar to that on food. The Authority has already concluded that for food isoeugenol is efficacious, as it increases the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The Authority concluded that the simultaneous use in feed and water for drinking should be avoided. However, those substances can be used within compound feeds which are subsequently administered via water.

(5)

Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials.

(6)

The Authority concluded that isoeugenol is an irritant to the respiratory tract, skin and eyes and it is also a skin and respiratory sensitiser. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. 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.

(7)

The assessment of the substance concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for that substance it is appropriate to allow 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,