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 an authorisation. 

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,4- beta-glucanase and xyloglucan-specific-endo-beta-1,4-glucanase produced with Trichoderma citrinoviride DSM 33578. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. 

(3) The application concerns the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific-endo-beta-1,4-glucanase produced with Trichoderma citrinoviride DSM 33578 as a feed additive for all reproductive Suidae and all Suidae for fattening, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. 

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 1 February 2024 that, under the proposed conditions of use, the preparation of endo1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific-endo-beta-1,4- glucanase produced with Trichoderma citrinoviride DSM 33578 does not have adverse effects on animal health, consumer safety or the environment. The Authority also concluded that the preparation in granulated formulation is not an irritant to the skin and eyes but should be considered a skin sensitiser. It further concluded that the liquid formulation of the preparation is considered not to be an irritant to the skin and eyes, and not a skin sensitiser. However, both formulations of the preparation are considered respiratory sensitisers. The Authority further concluded that the preparation has the potential to be efficacious in all reproductive Suidae at the use level of 1500 EPU, 100 CU and 100 XGU/kg complete feed. Due to the lack of sufficient data, the Authority was not able to conclude on the efficacy for Suidae for fattening. It did not consider that there is a need for specific requirements of post-market monitoring. 

(5) In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005, the Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the previous assessment concerning the same additive are valid and applicable for the current application. 

(6) In view of the above, the Commission considers that the preparation of endo-1,4-betaxylanase, endo-1,4-beta-glucanase and xyloglucan-specific-endo-beta-1,4-glucanase produced with Trichoderma citrinoviride DSM 33578 satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for sows of all Suidae species. 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. Regarding the target species for which the Authority’s opinion was inconclusive, the applicant committed to providing supplementary information. 

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