(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 lavender tincture from Lavandula angustifolia Mill. and lavender tincture from Lavandula angustifolia × L. latifolia were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. These substances were subsequently entered in the Register of Feed Additives as existing products, 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 lavender tincture from Lavandula angustifolia Mill. and of lavender tincture from Lavandula angustifolia × L. latifolia 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’. 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 substances concerned 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 these additives in water for drinking should not be allowed. 

(5)    The European Food Safety Authority (‘the Authority’) concluded in its opinion of 25 June 2025  that lavender tincture from Lavandula angustifolia Mill. is of no safety concern for the target species for fattening and that it is very unlikely to induce adverse effects for any other species and for long-living and reproductive animals, at certain maximum concentrations further specified in that opinion for each species. Furthermore, it concluded that no safety concern for consumers nor a risk to the environment would be expected from the use of lavender tincture from Lavandula angustifolia Mill. up to the specified maximum concentrations for each species. The Authority concluded that lavender tincture from Lavandula angustifolia Mill. should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The Authority indicated that unprotected users might be exposed to methyleugenol when handling the additive and that therefore, in order to reduce the risk, the exposure of the users to the substance should be minimised. It further concluded that since the flowers of Lavandula angustifolia Mill. 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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. In addition, the Authority stated that the applicant submitted no data for any tincture from Lavandula angustifolia × L. latifolia.
(6)    Subsequently, the applicant withdrew the application for authorisation of lavender tincture from Lavandula angustifolia × L. latifolia for all animal species.
(7)    In view of the above, the Commission considers that lavender tincture from Lavandula angustifolia Mill. satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that additive should be authorised as specified in the Annex to this Regulation. 
(8)    The Commission considers that the presence of methyleugenol, a substance of concern belonging to p-allylalkoxybenzenes group, in lavender tincture from Lavandula angustifolia Mill., requires the setting of a maximum content for this feed additive in complete feed. It also considers that the simultaneous use of lavender tincture from Lavandula angustifolia Mill. 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.
(9)    According to Article 10(5) of Regulation (EC) No 1831/2003, the Commission is to adopt a Regulation requiring the withdrawal from the market of feed additives for which no applications were submitted before the deadline provided for in Article 10(2) of Regulation (EC) No 1831/2003. Similarly, a Regulation should be adopted concerning feed additives for which an application was submitted but subsequently withdrawn. 

(10)    Therefore, lavender tincture from Lavandula angustifolia × L. latifolia should be withdrawn from the market for all animal species.
(11)    Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of lavender tincture from Lavandula angustifolia Mill., it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
(12)    In addition, in so far as lavender tincture from Lavandula angustifolia × L. latifolia is withdrawn from the market, it is also appropriate to allow for a transitional period within which existing stocks of the additive concerned, and of premixtures, feed materials and compound feed which have been produced with that additive, may be used up, in order to allow interested parties to adapt to the obligation to withdraw those products from the market.
(13)    The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,