(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 authorisation.

(2)

The preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 143953 (previously taxonomically identified as ATCC PTA-5588) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei CBS 143945 (previously taxonomically identified as ATCC SD-2106) was authorised for 10 years as a feed additive for poultry, weaned piglets and pigs for fattening by Commission Regulation (EU) No 337/2011 (2), and for lactating sows and minor porcine species (weaned piglets, pigs for fattening and lactating sows) by Commission Implementing Regulation (EU) 2016/997 (3).

(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 by Trichoderma reesei CBS 143953 and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei CBS 143945 as a feed additive for poultry species, weaned piglets, pigs for fattening, lactating sows and minor porcine species (weaned piglets, pigs for fattening and lactating sows), requesting the additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. The application included a proposal for amending the conditions of the original authorisation, consisting of a reduction of the minimum recommended level for turkeys. The application also included a request in accordance with Article 7 of Regulation (EC) No 1831/2003 for the authorisation of the same preparation as a feed additive for suckling piglets and minor porcine species (suckling piglets). The application was accompanied by the particulars and documents required respectively under Article 14(2) and 7(3) of that Regulation.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 September 2022 (4) that the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 143953 and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei CBS 143945 remains safe for poultry species, weaned piglets, pigs for fattening, lactating sows and minor porcine species (weaned piglets, pigs for fattening and lactating sows), consumers and the environment under the conditions of use currently authorised. It added that those conclusions on safety apply also to the use of that preparation for suckling piglets and minor porcine species (suckling piglets). It further stated that the preparation should be considered a potential eye irritant and a respiratory sensitiser, while no conclusions could be drawn on the skin irritancy and sensitisation potential of the preparation. The Authority also concluded that there was no need for an assessment of the efficacy of the preparation for poultry species other than turkeys, for weaned piglets, pigs for fattening, lactating sows and minor porcine species (weaned piglets, pigs for fattening and lactating sows), and that the preparation was considered efficacious in turkeys, suckling piglets and minor porcine species (suckling piglets) at the newly proposed intended level of 610 Units of activity of endo-1,4-beta-xylanase per kilogramme of complete feedingstuff and 76 Units of activity of endo-1,3(4)-beta-glucanase per kilogramme of complete feedingstuff. However, the Authority also highlighted that the actual effective level used in the studies supporting the conclusions on efficacy for all target species, except lactating sows and minor porcine species (lactating sows), was approximately 50 % higher than the newly proposed intended level. Finally, the Authority concluded that there was no need for specific requirements of post-market monitoring.

(5)

In accordance with Article 5(4), first subparagraph, points (a) and (c), of Commission Regulation (EC) No 378/2005 (5), the Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the previous assessment of 28 June 2010 (6) are valid and applicable to the current application.

(6)

The assessment of the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 143953 and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei CBS 143945 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that preparation should be renewed for poultry species, weaned piglets, pigs for fattening, lactating sows and minor porcine species (weaned piglets, pigs for fattening and lactating sows) and the use of that preparation should be authorised for suckling piglets and minor porcine species (suckling piglets). However, it is appropriate to set the minimum content applicable to poultry species, suckling piglets, weaned piglets, pigs for fattening and minor porcine species (suckling piglets, weaned piglets and pigs for fattening) 50 % higher than the intended level in order to ensure the efficacy of that preparation when fed to those target species and categories.

(7)

The Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.

(8)

As a consequence of the renewal of the authorisation of the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 143953 and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei CBS 143945 as a feed additive, Regulation (EU) No 337/2011 and Implementing Regulation (EU) 2016/997 should be repealed.

(9)

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 by Trichoderma reesei CBS 143953 and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei CBS 143945 for use for poultry species, weaned piglets, pigs for fattening and minor porcine species (weaned piglets and pigs for fattening), it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements.

(10)

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