Commission Implementing Regulation (EU) 2024/2184 of 3 September 2024 concerning the authorisation of a preparation of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 as a feed additive for piglets and pigs for fattening of all Suidae species

Official Journal EN of the European Union L series 2024/2184 4.9.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/2184 of 3 September 2024 concerning the authorisation of a preparation of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 as a feed additive for piglets and pigs for fattening of all Suidae species (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 2003on 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 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(2) 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(3) 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.

(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2) Commission Regulation (EC) No 386/2009 of 12 May 2009 amending Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the establishment of a new functional group of feed additives (OJ L 118, 13.5.2009, p. 66, ELI: http:// data.europa.eu/eli/reg/2009/386/oj).

(3) EFSA Journal 2024, 22(3), e8614.

ELI: http://data.europa.eu/eli/reg_impl/2024/2184/oj 1/4EN OJ L, 4.9.2024

(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,

HAS ADOPTED THIS REGULATION:

Article 1 Authorisation The substance specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘substances for reduction of the contamination of feed by mycotoxins’, 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, 3 September 2024.

For the Commission The President Ursula VON DER LEYEN 2/4 ELI: http://data.europa.eu/eli/reg_impl/2024/2184/ojANNEX Minimum Maximum Identifica- content content tion Composition, chemical formula, Species or category of Maximum End of period of number of Additive Other provisions description, analytical method animal age Units of activity/kg authorisation the feed complete feedingstuff with additive 12 % moisture content

Category: technological additives. Functional group: substances for reduction of the contamination of feed by mycotoxins: fumonisins 1m04 Fumonisin ester­ Additive composition Piglets of all Suidae — 60 60 1. In the directions for use of 24 September ase EC 3.1.1.87 Preparation of fumonisin esterase species the additive and 2034 produced with Komagataella phaffii premixtures, the storage NCAIM (P) Y001485 containing a Pigs for fattening of conditions and stability to minimum of 1 200 U(1)/g. all Suidae species heat treatment shall be indicated.

2. The additive shall only be Solid form used in feed which is already compliant with the Characterisation of the active substance rules established for Fumonisin esterase (EC 3.1.1.87) mycotoxins in Union law on produced with Komagataella phaffii undesirable substances in NCAIM (P) Y001485 animal feed.

3. For users of the additive and Analytical method(2) premixtures, feed business For the determination of fumonisin operators shall establish B1 esterase activity in the feed operational procedures and additive, premixtures and com­ organisational measures to

pound feed: address potential risks resulting from their use.

Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin and breathing protective equipment.

ELI:

http://data.europa.eu/eli/reg_impl/2024/2184/oj 3/4 OJ L,

4.9.2024 ENMinimum Maximum Identifica- content content tion Composition, chemical formula, Species or category of Maximum End of period of number of Additive Other provisions description, analytical method animal age Units of activity/kg authorisation the feed complete feedingstuff with additive 12 % moisture content

Category: technological additives. Functional group: substances for reduction of the contamination of feed by mycotoxins: fumonisins High Performance Liquid Chroma­ tography coupled to fluorescence detection (HPLC-FLD) based on the quantification of hydrolysed fumo­ nisin B1 released from the action of the enzyme on fumonisin B1 at pH 6,0 and 37 °C.

(1) One unit (U) is the amount of enzyme that releases one μmol of HFB1 per minute from 100 μM of FB1 in 50 mM phosphate buffer pH 6,0 at 37 °C.

(2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en.

4/4

ELI:

http://data.europa.eu/eli/reg_impl/2024/2184/oj EN OJ L,

4.9.2024