Safety and efficacy of a feed additive consisting of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 for all pigs (piglets, pigs for fattening, sows and minor growing and reproductive porcine species) (Dr. Bata Ltd.)

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the additive based on fumonisin esterase (Free Yeast® F), produced with a genetically modified strain of Komagataella phaffii. The additive is categorised as a tech...

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Main Authors: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Roberto Edoardo Villa, Ruud Woutersen, Giovanna Martelli, Rosella Brozzi, Jaume Galobart, Matteo Lorenzo Innocenti, Jordi Ortuño, Elisa Pettenati, Fabiola Pizzo, Jordi Tarrés‐Call, Maria Vittoria Vettori, Anita Radovnikovic
Format: Article
Language:English
Published: Wiley 2024-03-01
Series:EFSA Journal
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Online Access:https://doi.org/10.2903/j.efsa.2024.8614
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author EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Roberto Edoardo Villa
Ruud Woutersen
Giovanna Martelli
Rosella Brozzi
Jaume Galobart
Matteo Lorenzo Innocenti
Jordi Ortuño
Elisa Pettenati
Fabiola Pizzo
Jordi Tarrés‐Call
Maria Vittoria Vettori
Anita Radovnikovic
author_facet EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Roberto Edoardo Villa
Ruud Woutersen
Giovanna Martelli
Rosella Brozzi
Jaume Galobart
Matteo Lorenzo Innocenti
Jordi Ortuño
Elisa Pettenati
Fabiola Pizzo
Jordi Tarrés‐Call
Maria Vittoria Vettori
Anita Radovnikovic
author_sort EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
collection DOAJ
description Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the additive based on fumonisin esterase (Free Yeast® F), produced with a genetically modified strain of Komagataella phaffii. The additive is categorised as a technological feed additive, for the reduction of the contamination of feed by mycotoxins and intended for use in all pigs species (piglets, pigs for fattening, sows and minor growing and reproductive porcine species). It was shown that the production strain and its recombinant genes are not present in the additive. The FEEDAP Panel concluded that the additive is safe for weaned and suckling piglets and pigs for fattening, and all minor growing porcine species up to 60 U/kg complete feed. No conclusions can be drawn on the safety of the additive in sows. The use of the additive in animal nutrition is of no concern for consumer safety. The additive is dust‐free, and therefore, respiratory sensitisation/irritation is unlikely. The additive is non‐irritant to the eyes and the skin. No conclusion could be made on skin sensitisation. The use of the additive as a feed additive is considered safe for the environment. The Panel concluded that the additive is efficacious as technological feed additive for the reduction of feed contamination by fumonisins, when used at the minimum recommended concentration of 60 U/kg. This conclusion can be extrapolated to all growing and reproductive pigs and other minor porcine species.
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spelling doaj-art-5679edc7ef2d4f24af874a88afb5f0a92025-08-20T03:25:40ZengWileyEFSA Journal1831-47322024-03-01223n/an/a10.2903/j.efsa.2024.8614Safety and efficacy of a feed additive consisting of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 for all pigs (piglets, pigs for fattening, sows and minor growing and reproductive porcine species) (Dr. Bata Ltd.)EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMojca DurjavaMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosRoberto Edoardo VillaRuud WoutersenGiovanna MartelliRosella BrozziJaume GalobartMatteo Lorenzo InnocentiJordi OrtuñoElisa PettenatiFabiola PizzoJordi Tarrés‐CallMaria Vittoria VettoriAnita RadovnikovicAbstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the additive based on fumonisin esterase (Free Yeast® F), produced with a genetically modified strain of Komagataella phaffii. The additive is categorised as a technological feed additive, for the reduction of the contamination of feed by mycotoxins and intended for use in all pigs species (piglets, pigs for fattening, sows and minor growing and reproductive porcine species). It was shown that the production strain and its recombinant genes are not present in the additive. The FEEDAP Panel concluded that the additive is safe for weaned and suckling piglets and pigs for fattening, and all minor growing porcine species up to 60 U/kg complete feed. No conclusions can be drawn on the safety of the additive in sows. The use of the additive in animal nutrition is of no concern for consumer safety. The additive is dust‐free, and therefore, respiratory sensitisation/irritation is unlikely. The additive is non‐irritant to the eyes and the skin. No conclusion could be made on skin sensitisation. The use of the additive as a feed additive is considered safe for the environment. The Panel concluded that the additive is efficacious as technological feed additive for the reduction of feed contamination by fumonisins, when used at the minimum recommended concentration of 60 U/kg. This conclusion can be extrapolated to all growing and reproductive pigs and other minor porcine species.https://doi.org/10.2903/j.efsa.2024.8614Free Yeast® Ffumonisin esteraseKomagataella phaffiimycotoxins reductiontechnological additive
spellingShingle EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Roberto Edoardo Villa
Ruud Woutersen
Giovanna Martelli
Rosella Brozzi
Jaume Galobart
Matteo Lorenzo Innocenti
Jordi Ortuño
Elisa Pettenati
Fabiola Pizzo
Jordi Tarrés‐Call
Maria Vittoria Vettori
Anita Radovnikovic
Safety and efficacy of a feed additive consisting of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 for all pigs (piglets, pigs for fattening, sows and minor growing and reproductive porcine species) (Dr. Bata Ltd.)
EFSA Journal
Free Yeast® F
fumonisin esterase
Komagataella phaffii
mycotoxins reduction
technological additive
title Safety and efficacy of a feed additive consisting of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 for all pigs (piglets, pigs for fattening, sows and minor growing and reproductive porcine species) (Dr. Bata Ltd.)
title_full Safety and efficacy of a feed additive consisting of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 for all pigs (piglets, pigs for fattening, sows and minor growing and reproductive porcine species) (Dr. Bata Ltd.)
title_fullStr Safety and efficacy of a feed additive consisting of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 for all pigs (piglets, pigs for fattening, sows and minor growing and reproductive porcine species) (Dr. Bata Ltd.)
title_full_unstemmed Safety and efficacy of a feed additive consisting of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 for all pigs (piglets, pigs for fattening, sows and minor growing and reproductive porcine species) (Dr. Bata Ltd.)
title_short Safety and efficacy of a feed additive consisting of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 for all pigs (piglets, pigs for fattening, sows and minor growing and reproductive porcine species) (Dr. Bata Ltd.)
title_sort safety and efficacy of a feed additive consisting of fumonisin esterase produced with komagataella phaffii ncaim p y001485 for all pigs piglets pigs for fattening sows and minor growing and reproductive porcine species dr bata ltd
topic Free Yeast® F
fumonisin esterase
Komagataella phaffii
mycotoxins reduction
technological additive
url https://doi.org/10.2903/j.efsa.2024.8614
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