Commission Implementing Regulation (EU) 2023/1169 of 15 June 2023 concerning the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 as a feed additive for poultry for fattening, poultry reared for laying and reared for breeding, and ornamental birds (holder of authorisation: Huvepharma EOOD) (Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(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 endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) That application concerns the authorisation of the preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 as a feed additive for all poultry species, ornamental birds and piglets, to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 23 November 2022 (2) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 does not have adverse effects on animal health, consumer safety or the environment. The Authority also concluded that the preparation should be considered a respiratory sensitiser but, in the absence of data, could not conclude on the irritancy potential of the preparation to skin. The Authority also concluded that the preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 has the potential to be efficacious in poultry for fattening, poultry reared for laying and reared for breeding, and ornamental birds. However, owing to the lack of sufficient data, the Authority could not conclude on the efficacy of the preparation for laying hens and weaned piglets. The Authority considered that there was no need for specific requirements of post-market monitoring. It 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 assessment of the preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied for poultry for fattening, poultry reared for laying and reared for breeding, and ornamental birds. Accordingly, the use of that preparation should be authorised for those animal species and categories. In addition, 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.

(6) It has been proposed to, and accepted by, the applicant to submit supplementary information addressing the shortcomings identified in the Authority’s opinion concerning the efficacy of the preparation for laying hens and weaned piglets.

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

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 June 2023.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 268, 18.10.2003, p. 29.

(2) EFSA Journal 2022; 20(12):7702.