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 gentian tincture from Gentiana lutea 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 gentian tincture from Gentiana lutea 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’. 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 the additive in water for drinking should not be allowed. 

(5) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 18 March 2021 and 1 February 2023 that, under the proposed conditions of use, gentian tincture from Gentiana lutea L. is safe for short-living animals, i.e., animal species for fattening, for consumers and for the environment. It stated that no conclusions could be drawn for long-living animals and reproductive animals in the absence of data on the in vivo genotoxicity of xanthones (gentisin and isogentisin) and gentiopicroside. Furthermore, the Authority could not conclude on the potential of the additive to be a dermal/eye irritant or a skin sensitiser, in the absence of data. It also noted that when handling the tincture, exposure of unprotected users to the potential genotoxicants xanthones (gentisin and isogentisin) and gentiopicroside cannot be excluded and that therefore, to reduce the risk, the exposure of the users should be minimised. In addition, the Authority concluded that since gentian tincture from Gentiana lutea L. 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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. 

(6) Subsequently, the applicant withdrew the application for authorisation of gentian tincture from Gentiana Lutea L. for all animal species and categories except: animal species for fattening other than Equidae and salmonids and minor fin fish other than brood stock. 

(7) In view of the above, the Commission considers that gentian tincture from Gentiana lutea L. satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003, as regards animal species for fattening except Equidae, salmonids and fin fish except brood stock, and provided in particular that the additive is not used in combination with other additives containing gentisin, isogentisin and gentiopicroside. Accordingly, the use of that substance should be authorised. 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. 

(8) Article 10(5) of Regulation (EC) No 1831/2003 imposes an obligation on the Commission to adopt a Regulation requiring the withdrawal from the market of feed additives for which no applications as required by Article 10(2) of Regulation (EC) No 1831/2003 were submitted before the deadline provided for in that provision. Similarly, a Regulation should be adopted concerning feed additives for which an application was submitted but subsequently withdrawn. 

(9) In the case of feed additives for which an application has been withdrawn only for certain animal species or categories, the withdrawal from the market should only concern those animal species or categories. 

(10) Therefore, gentian tincture from Gentiana lutea L. should be withdrawn from the market as regards the animal species and categories which are not the subject of the authorisation granted by this Regulation. 

(11) In so far as this Regulation authorises gentian tincture from Gentiana lutea L. as a feed additive, safety reasons do not require the immediate application of the modifications to the conditions of authorisation of that substance in respect of the animal species and categories which are covered by the authorisation granted by this Regulation. It is therefore 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 the feed additive is withdrawn from the market, it is also appropriate to allow for a transitional period within which existing stocks of the additive, premixtures, feed materials and compound feed which have been produced with that additive, may be used up also in respect of the animal species and categories of animals which are not covered by the authorisation granted by this Regulation, 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,