(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 alpha-galactosidase produced with Aspergillus tubingensis ATCC SD 6740 and endo-1,4-beta-xylanase produced with Trichoderma orientale (previously allocated to the species Trichoderma longibrachiatum) CBS 139997. 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 alpha-galactosidase produced with Aspergillus tubingensis ATCC SD 6740 and endo-1,4-beta-xylanase produced with Trichoderma orientale CBS 139997 as a feed additive for weaned piglets requesting the additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.

(4)    The European Food Safety Authority (‘the Authority’) concluded in its opinion of  27 January 2026  that the preparation of alpha-galactosidase produced with Aspergillus tubingensis ATCC SD 6740 and endo-1,4-beta-xylanase produced with Trichoderma orientale CBS 139997 is safe for weaned piglets at the recommended inclusion level of 20 alpha-galactosidase activity units (GALU) and 25 endo-1,4-beta-xylanase activity units (AXC) units per kg complete feed, as well as for the consumers and the environment. The Authority also concluded that the preparation of alpha-galactosidase produced with Aspergillus tubingensis ATCC SD 6740 and endo-1,4-beta-xylanase produced with Trichoderma orientale CBS 139997 is considered a respiratory sensitiser and exposure by inhalation is considered a risk. No conclusions were reached on the potential of the additive to be irritant to the skin or eyes or a skin sensitiser. The Authority further concluded that the preparation of alpha-galactosidase produced with Aspergillus tubingensis ATCC SD 6740 and endo-1,4-beta-xylanase produced with Trichoderma orientale CBS 139997 has the potential to be efficacious as a zootechnical additive in weaned piglets at the recommended use level of 20 GALU and 25 AXC units per kg complete feed. The Authority did not consider that there is a need for specific requirements of post-market monitoring.

(5)    The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment concerning another application for the authorisation of the same additive and verified by the Authority in its opinion of 19 March 2020  are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005 , an evaluation report of the Reference Laboratory was therefore not required.

(6)    In view of the above, the Commission considers that the preparation of alpha-galactosidase produced with Aspergillus tubingensis ATCC SD 6740 and endo-1,4-beta-xylanase produced with Trichoderma orientale CBS 139997 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for weaned piglets. 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)    The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed