BAKGRUNN (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, modifying and renewing such an authorisation.

(2) A preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 26372 was authorised for a period of 10 years as a feed additive for poultry for fattening, weaned piglets and pigs for fattening by Commission Implementing Regulation (EU) No 1206/2012 (2), for lactating sows by Commission Implementing Regulation (EU) 2020/995 (3) and for laying hens by Commission Implementing Regulation (EU) 2020/1034 (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 endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 26372 as a feed additive for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. In the context of that application, the holder of the authorisation also proposed changing the terms of the authorisation of the preparation concerned by requesting for a change in the production strain, from Aspergillus oryzae DSM 26372 to Aspergillus oryzae DSM 33700 in accordance with Article 13(3) of Regulation (EC)No 1831/2003. The application was accompanied by the particulars and documents required under Article 14(2) and by the relevant data supporting the request for the change.

(4) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of new uses of the preparation endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 33700. The application concerns the authorisation of that preparation as a feed additive for all poultry species and all Suidae, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 September 2023 (5) that the preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 33700 remains safe for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, the consumers and the environment under the conditions of use currently authorised. It also concluded that the additive is safe for all poultry and all Suidae, the consumers and the environment, under the recommended conditions of use. The Authority further stated that both formulations of the additive (liquid and solid) were not irritant to skin. Liquid formulation is not an eye irritant, however, no conclusions can be drawn on the potential of solid formulation to be an eye irritant. Due to the lack of data, the Authority was not able to conclude on the potential of both formulations of the additive to be dermal sensitisers. Due to the proteinaceous nature of the active substance (xylanase), the additive is considered a respiratory sensitiser. As regards the proposed new uses for the additional target species, the Authority concluded that the additive has the potential to be efficacious in all poultry species and in all Suidae at the proposed conditions of use. The Authority further concluded that the preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 33700 remains efficacious for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens. The Authority did not consider that there is a need for specific requirements of post-market monitoring.

(6) 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 by Aspergillus oryzae DSM 33700 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), point (c), of Commission Regulation (EC) No 378/2005 (6), an evaluation report of the Reference Laboratory is therefore not required.

(7) In view of the above, the Commission considers that the preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 33700 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 for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, and the use of that preparation should be authorised for all poultry species other than poultry for fattening and laying hens, and all Suidae other than weaned piglets, pigs for fattening and lactating sows. 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.

(8) As a consequence of the renewal of the authorisation of the preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 33700 as a feed additive for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, Implementing Regulations (EU) No 1206/2012, (EU) No 2020/995 and (EU) 2020/1034 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 Aspergillus oryzae DSM 33700 for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, 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.

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