(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 and endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 was authorised for a period of 10 years as a feed additive for weaned piglets by Commission Implementing Regulation (EU) No 1088/2011 (2), for laying hens and minor poultry species for laying and fattening by Commission Implementing Regulation (EU) No 989/2012 (3), for pigs for fattening, minor porcine species for fattening other than Sus scrofa domesticus and turkeys for fattening by Commission Implementing Regulation (EU) No 1040/2013 (4).

(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 and endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 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, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. 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) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, another application was submitted for the renewal of the authorisation of the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755 and endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 as a feed additive for laying hens and minor poultry species for laying and fattening, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

(5) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, another application was submitted for the renewal of the authorisation of the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755 and endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 as a feed additive for pigs for fattening, minor porcine species for fattening other than Sus scrofa domesticus and turkeys for fattening, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

(6) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 5 June 2024 (5) and 3 July 2024 (6) that, under the current authorised conditions of use and considering the fact that the composition and manufacturing of the additive have not been substantially modified, both formulations (powder and liquid) of the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755 and endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 remain safe for weaned piglets, laying hens and minor poultry species for laying and fattening, pigs for fattening, minor porcine species for fattening and turkeys for fattening, the consumers and the environment. It also concluded that the extension of use to suckling piglets would not affect these conclusions. The Authority further concluded that the preparation in its powder formulation, containing calcium carbonate and sepiolite, and the liquid form of the preparation are not irritant to skin and eyes. Due to the lack of data, no conclusions on the irritation potential of the powder formulation of the preparation formulated with calcium carbonate and wheat flour could be drawn. The additive, in all its formulations, is considered a respiratory and skin 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 that would have an impact on the efficacy of the additive for those species/categories for which there is an authorisation. It considered that the conclusions reached for those species can be extended to other species and therefore concluded that the additive has the potential to be efficacious in suckling piglets at 4 000 XU and 900 BGU/kg complete feed. The Authority did not consider that there is a need for specific requirements of post-market monitoring.

(7) 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 and endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 as a feed additive in the context of the previous authorisations are valid and applicable for the current applications. In accordance with Article 5(4), points (a) and (c), of Commission Regulation (EC) No 378/2005 (7), an evaluation report of the Reference Laboratory is therefore not required.

(8) In view of the above, the Commission considers that the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755 and endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 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, laying hens, minor poultry species for laying and fattening, pigs for fattening of all Suidae species (which covers pigs for fattening and minor porcine species for fattening) and turkeys for fattening. Furthermore, 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.

(9) As a consequence of the renewal of the authorisation of the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755 and endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 as a feed additive for weaned piglets, laying hens, minor poultry species for laying and fattening, pigs for fattening of all Suidae species and turkeys for fattening, Implementing Regulations (EU) No 1088/2011, (EU) No 989/2012 and (EU) No 1040/2013 should be repealed.

(10) 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 and endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 for weaned piglets, laying hens, minor poultry species for laying and fattening, pigs for fattening of all Suidae species and turkeys for fattening, 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 authorisations concerned.

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