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).

(2) The substance pine tincture from Pinus sylvestris 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, 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 pine tincture from Pinus sylvestris L. as a feed additive for all animal species. The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’ and to be authorised also for use in water for drinking. 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 4 July 2023 (3) that, under the proposed conditions of use, pine tincture from Pinus sylvestris L. is safe for all animal species, consumers and the environment. Furthermore, the Authority stated that the further demonstration of efficacy is not necessary as twigs of Pinus sylvestris L. are used to flavour food and are considered similar in composition to the source material for the production of pine tincture. It concluded that pine tincture from Pinus sylvestris L. should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. 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.

(5) In view of the above, the Commission considers that pine tincture from Pinus sylvestris 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 appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.

(6) In addition, in order to allow better control, flavourings should be incorporated in feed in the form of premixtures. The Commission considers that for pine tincture from Pinus sylvestris L., safety reasons do not require the setting of maximum levels. In order to allow better control, a recommended maximum content should be indicated on the label of the additive. Where the recommended maximum content is exceeded, certain information should be indicated on the label of the premixtures concerned.

(7) Regulation (EC) No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water for drinking. Therefore, the use of that additive in water for drinking should not be allowed.

(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of pine tincture from Pinus sylvestris 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,