(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 6-phytase produced by Aspergillus oryzae DSM 22594 was authorised for 10 years as a feed additive for poultry, weaned piglets, pigs for fattening and sows by Commission Implementing Regulation (EU) No 837/2012 (2).

(3)

In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of 6-phytase produced by Aspergillus oryzae DSM 33699 as a feed additive for poultry, pigs for fattening, weaned piglets and sows in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. The application requested to change the production strain, substituting the strain Aspergillus oryzae DSM 22594 for Aspergillus oryzae DSM 33699, and was accompanied by the particulars and documents required under Article 14(2) of that Regulation.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 22 November 2022 (3) that new production strain Aspergillus oryzae DSM 33699 does not give rise to safety concerns and that, under the proposed conditions of use, the preparation of 6-phytase produced by Aspergillus oryzae DSM 33699 is safe for the target species, for consumers and the environment. As regards safety for the users when handling the preparation, due to the absence of data on the final formulations, the Authority could not conclude on the potential of the additive to be irritant to eyes or skin or to be a skin sensitiser but considered that the additive is a respiratory sensitiser. The Authority finally concluded that the additive has the potential to be efficacious in poultry, pigs for fattening, weaned piglets and sows at the minimum recommended level of 500 FYT/kg complete feed.

(5)

In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005 (4), the Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the previous assessment are valid and applicable for the current application.

(6)

The assessment of the preparation of 6-phytase produced by Aspergillus oryzae DSM 33699 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of this additive should be renewed.

(7)

The Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation concerned, it is appropriate to provide for a transitional period for the interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(9)

As a consequence of the renewal of the authorisation of the preparation of 6-phytase produced by Aspergillus oryzae DSM 33699 as a feed additive, Implementing Regulation (EU) No 837/2012 should be repealed.

(10)

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