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 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 fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485. 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 fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 as a feed additive for all pigs, requesting that additive to be classified in the category ‘technological additives’ and in the functional group ‘substances for reduction of the contamination of feed by mycotoxins’. 

(4) The use of this additive, as indicated in Commission Regulation (EC) No 386/2009 establishing the functional group ‘substances for reduction of the contamination of feed by mycotoxins’, should improve the quality of the feed for animal nutrition which is lawfully on the market, providing additional guarantees for the protection of animal and public health. 

(5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 January 2024 that the preparation of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 is safe up to 60 U/kg complete feed for weaned and suckling piglets, pigs for fattening and all minor growing porcine species and that its use in animal nutrition under the proposed conditions of use is safe for the consumers and environment. In the absence of adequate data, the Authority could not conclude on the safety of the additive at the maximum proposed use level (360 U/kg) nor on the safety for sows and minor reproductive porcine species. It also concluded that the preparation of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 is considered to be a respiratory sensitiser, although the exposure through inhalation is unlikely, it is neither a skin nor an eye irritant, while no conclusions could be made on its skin sensitisation potential. The Authority further concluded that the substance is efficacious in reducing the fumonisins contamination in feed when added at the minimum use level of 60 U/kg feed for all Suidae. The Authority also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. 

(6) Subsequently, the applicant withdrew the application for sows and minor reproductive porcine species. 

(7) In view of the above, the Commission considers that the preparation of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised for piglets and pigs for fattening of all Suidae species. 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. 

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