Kommisjonens gjennomføringsforordning (EU) 2023/2802 av 18. desember 2023 om godkjenning av et preparat av endo-1,4-beta-xylanase fremstilt av Komagataella phaffii ATCC PTA-127053 som tilsetningsstoff i fôrvarer til alle fjørfearter for oppfôring, avl, og oppdrett for egglegging eller avl (innehaver av godkjenningen: Kemin Europa N.V.)
Godkjenning av endo-1,4-beta-xylanase framstilt av Komagataella phaffii ATCC PTA-127053 som tilsetningsstoff i fôrvarer til fjørfe
Commission Implementing Regulation (EU) 2023/2802 of 18 December 2023 concerning the authorisation of a preparation of endo–1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 as a feed additive for all poultry species for fattening, breeding, and reared for laying or breeding (holder of authorisation: Kemin Europa N.V.)
EØS/EFTA-landenes utkast til EØS-komitebeslutning oversendt til Kommisjonen 3.4.2024
Tidligere
- Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 12.12.2023
- Kommisjonsforordning publisert i EU-tidende 19.12.2023
Nærmere omtale
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 endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 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 endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 as a feed additive for all poultry species, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.
(4) The use of that preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 has already been authorised for all laying poultry by Implementing Regulation (EU) 2023/6682 based on the conclusions of the opinion of 29 June 20223 of the European Food Safety Authority (‘the Authority’).
(5) The Authority concluded in its opinions of 29 June 2022 and 11 May 20234 that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 is safe for all poultry species, consumers and the environment. It also concluded that the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 is not irritant to the eyes and skin but should be considered a dermal and a respiratory sensitiser. The Authority further concluded that the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 has the potential to be efficacious for all poultry species under the proposed conditions of use. 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.
(6) In view of the above, the Commission considers that the preparation of endo-1,4-betaxylanase produced by Komagataella phaffii ATCC PTA-127053 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, breeding, and reared for laying or breeding. 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,