(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 6-phytase produced with Trichoderma reesei CBS 126897 was authorised for a period of 10 years as a feed additive for poultry, weaned piglets, pigs for fattening and sows by Commission Implementing Regulation (EU) No 292/2014 (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 6-phytase produced with Trichoderma reesei CBS 126897 as a feed additive for poultry other than laying birds, laying birds, weaned piglets, pigs for fattening, and sows, 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 and other porcine species and ornamental birds, 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) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 May 2025 (3) that, under the current authorised conditions of use and considering the fact that the manufacturing and composition of the additive have not been substantially modified, the preparation of 6-phytase produced with Trichoderma reesei CBS 126897 remains safe for poultry, weaned piglets, pigs for fattening and sows, consumers and the environment. In addition, it concluded that the additive is safe for ornamental birds at 2 500 FTU/kg complete feed and for suckling piglets and other porcine species at 1 750 FTU/kg complete feed. The extension of use to these species is safe for the consumers and the environment. The Authority further concluded that the preparation in all its forms should be considered as respiratory sensitisers, and any exposure by inhalation should be considered a risk. However, the solid forms are dust-free, and the exposure of users by inhalation is unlikely. No conclusions can be reached on the potential of the different formulations to be irritants to skin and eyes or skin sensitisers. The Authority stated that the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additives. Therefore, it concluded that there is no need for assessing the efficacy of the additives in the context of the renewal of the authorisation. It considered that the conclusions reached in the original authorisation can be extended to other species and therefore concluded that the additive has the potential to be efficacious in in ornamental birds at 250 FTU/kg complete feed, in suckling piglets and in suckling and weaned piglets of minor porcine species at 500 FTU/kg, and in minor porcine species for fattening or reared for reproduction and reproductive animals at 250 FTU/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 the assessment carried out regarding the method of analysis of 6-phytase produced with Trichoderma reesei CBS 126897 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 (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 6-phytase produced with Trichoderma reesei CBS 126897 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed for poultry, weaned piglets, pigs for fattening and sows. Furthermore, the use of that preparation should be authorised for ornamental birds, suckling piglets and minor porcine 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. 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 6-phytase produced with Trichoderma reesei CBS 126897 as a feed additive for poultry, weaned piglets, pigs for fattening and sows, Implementing Regulation (EU) No 292/2014 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 6-phytase produced with Trichoderma reesei CBS 126897 for poultry, weaned piglets, pigs for fattening and sows, 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,