(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 muramidase produced with Trichoderma reesei DSM 32338 as a feed additive. 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 the preparation of muramidase produced with Trichoderma reesei DSM 32338 as a feed additive for laying hens, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘other zootechnical additives’. 

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 April 2024 that, under the proposed conditions of use, the preparation of muramidase produced with Trichoderma reesei DSM 32338 is safe for the target species, consumers and the environment. It also concluded that the liquid formulation of the preparation is considered not irritant to the skin or eyes, that its solid formulation is considered not irritant to the skin, and that due to the proteinaceous nature of the preparation both formulations should be considered respiratory sensitisers. However, the Authority could not conclude on the potential of the preparation (both formulations) to be a dermal sensitiser or the potential of its solid formulation to be irritant to the eyes. The Authority further concluded that the preparation has the potential to be efficacious as a zootechnical additive for laying hens at 30,000 LSU(F)/kg feed. It 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 previous assessment regarding the methods used for the control of muramidase in animal feed 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 is therefore not required. 

(6) In view of the above, the Commission considers that the preparation of muramidase produced with Trichoderma reesei DSM 32338 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised. 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,