(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 nutmeg essential oil from Myristica fragrans Houtt. 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 nutmeg essential oil from Myristica fragrans Houtt. 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 also for use 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 12 May 2023  that nutmeg essential oil from Myristica fragrans Houtt. is considered to be of no safety concern for target short-living animals and very unlikely to induce adverse effects for long-living and reproductive animals and any other animal species at certain maximum concentrations, further specified in that opinion for each animal species. Furthermore, it concluded that no concern for consumer safety was identified from the use of nutmeg essential oil from Myristica fragrans Houtt., up to the highest proposed use level in feed. The Authority concluded that the use of nutmeg essential oil from Myristica fragrans Houtt. under the proposed conditions is not expected to pose a risk to the environment and that nutmeg essential oil from Myristica fragrans Houtt. should be considered as an irritant to skin and eyes, and as a skin and respiratory sensitiser. It also stated that, based on the presence of safrole ≥ 0,1%, nutmeg essential oil from Myristica fragrans Houtt. is classified as carcinogen (category 1B) and exposure by any route should be minimised. The Authority further concluded that since nutmeg essential oil from Myristica fragrans Houtt. 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 nutmeg essential oil from Myristica fragrans Houtt. 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. The Commission considers that the presence of myristicin, safrole, elemicin and methyelugenol, substances of concern belonging to p-allylalkoxybenzenes group, in nutmeg essential oil from Myristica fragrans Houtt. requires the setting of a maximum content for this feed additive in complete feed. Furthermore, the Commission considers that the simultaneous use of nutmeg essential oil from Myristica fragrans Houtt. with other feed additives is permitted provided that the combined content of p-allylalkoxybenzenes (methyleugenol, estragole, elemicin, safrole, myristicin, dillapiole, and apiole) in feed materials and compound feed remains below the content that would result from using the authorised feed additive with the highest content of those substances at its maximum or recommended maximum content for the relevant  animal species or  category. 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 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.

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