(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 and renewing such an authorisation.

(2) A preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis (originally identified as Aspergillus aculeatus) CBS 589.94 was authorised for a period of 10 years as a feed additive for weaned piglets by Commission Implementing Regulation (EU) No 527/2011 (2).

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis CBS 589.94 as a feed additive for weaned piglets, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. In accordance with Article 7 of Regulation (EC) No 1831/2003, that application also concerned the authorisation of a new use of the same preparation as a feed additive for suckling piglets. That application was accompanied by the particulars and documents required under Article 14(2) and Article 7(3) of Regulation (EC) No 1831/2003.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 June 2024 (3) that the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis CBS 589.94 remains safe for weaned piglets, consumers and the environment under the authorised conditions of use, and that this conclusion also applies to the extension of its use to suckling piglets. The Authority further concluded that the preparation in both formulations (powder and liquid) is not irritant to the skin or eyes but due to its proteinaceous nature should be considered a dermal and respiratory sensitiser. The Authority considered that there is no need to assess the efficacy of the additive in the context of the renewal of the authorisation as the application does not include a proposal for amending or supplementing the conditions of use for weaned piglets for which there is an authorisation. It also considered that the conclusions reached for weaned piglets can be extended and extrapolated to other species and therefore concluded that the additive has the potential to be efficacious in suckling piglets. 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 the assessment carried out regarding the method of analysis of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis CBS 589.94 as a feed additive in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), points (a) and (c), of Commission Regulation (EC) No 378/2005 (4), an evaluation report of the Reference Laboratory is therefore not required.

(6) In view of the above, the Commission considers that the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis CBS 589.94 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed for weaned piglets, and the use of that preparation should be authorised for suckling 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. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.

(7) As a consequence of the renewal of the authorisation of the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis CBS 589.94 as a feed additive for weaned piglets, Implementing Regulation (EU) No 527/2011 should be repealed.

(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis CBS 589.94 for weaned piglets, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of 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,