(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 Macleaya cordata mixture 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 a preparation of Macleaya cordata mixture as a feed additive for all poultry species (excluding laying and breeding birds), 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 12 May 2023 (2) that, under the proposed conditions of use, the preparation of Macleaya cordata mixture is safe for chickens for fattening and other poultry species for fattening, and for the environment, and is of low concern for consumers. No conclusion could be drawn on the safety of the preparation of Macleaya cordata mixture for poultry species reared for laying and reared for breeding owing to a concern for genotoxicity linked to the presence in the preparation of the DNA intercalators sanguinarine and chelerythrine. It also concluded that the preparation of Macleaya cordata mixture was shown to be irritant to the eyes but not irritant to skin or a skin sensitiser, and that the potential of the additive to be a respiratory sensitiser could not be excluded. The Authority further concluded that the preparation of Macleaya cordata mixture, under the proposed conditions of use, has the potential to be efficacious in improving performance of chickens for fattening. This conclusion was extended to chickens reared for laying and reared for breeding and extrapolated to all poultry species for fattening, reared for laying or reared for breeding. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

The applicant withdrew the application on 19 June 2023 for the authorisation of the preparation of Macleaya cordata mixture for poultry species reared for laying and reared for breeding.

(6)

In view of the above, the Commission considers that the preparation of Macleaya cordata mixture satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for all poultry species for fattening. 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,