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) The substance red quebracho extract from Schinopsis balansae Engl. or Schinopsis lorentzii (Griseb.) Engl. 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 red quebracho extract from Schinopsis balansae Engl. or Schinopsis lorentzii (Griseb.) Engl. 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 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 22 November 2022 that, under the proposed conditions of use, red quebracho extract from Schinopsis balansae Engl. or Schinopsis lorentzii (Griseb.) Engl. is safe for all animal species, for consumers and the environment. It also concluded that the extract under assessment is not an eye irritant but that in the absence of data, no conclusion can be drawn on its potential to be a skin irritant and a dermal and respiratory sensitiser. It further concluded that since the substance is recognised to flavour food and since 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 red quebracho extract from Schinopsis balansae Engl. or Schinopsis lorentzii (Griseb.) Engl. satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of this substance should be authorised. The Commission considers that due to the possible effect of this extract as medicinal product and other possible zootechnical effects thereof, a maximum level should be set in order to prevent this additive from being used for other purposes. 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,