Safety and efficacy of fumonisin esterase (FUMzyme®) as a technological feed additive for all avian species

Abstract FUMzyme® is an enzyme‐based feed additive intended to degrade fumonisin mycotoxins found as contaminants in feeds for avian species. It is produced from a genetically modified strain of Komagataella pastoris. The additive is already authorised for use with pigs. During the course of this as...

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Main Authors: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Guido Rychen, Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria deLourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Marta López‐Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace, Pieter Wester, Giovanna Martelli, Derek Renshaw, Secundino López Puente
Format: Article
Language:English
Published: Wiley 2016-11-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2016.4617
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author EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Guido Rychen
Gabriele Aquilina
Giovanna Azimonti
Vasileios Bampidis
Maria deLourdes Bastos
Georges Bories
Andrew Chesson
Pier Sandro Cocconcelli
Gerhard Flachowsky
Jürgen Gropp
Boris Kolar
Maryline Kouba
Marta López‐Alonso
Alberto Mantovani
Baltasar Mayo
Fernando Ramos
Maria Saarela
Roberto Edoardo Villa
Robert John Wallace
Pieter Wester
Giovanna Martelli
Derek Renshaw
Secundino López Puente
author_facet EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Guido Rychen
Gabriele Aquilina
Giovanna Azimonti
Vasileios Bampidis
Maria deLourdes Bastos
Georges Bories
Andrew Chesson
Pier Sandro Cocconcelli
Gerhard Flachowsky
Jürgen Gropp
Boris Kolar
Maryline Kouba
Marta López‐Alonso
Alberto Mantovani
Baltasar Mayo
Fernando Ramos
Maria Saarela
Roberto Edoardo Villa
Robert John Wallace
Pieter Wester
Giovanna Martelli
Derek Renshaw
Secundino López Puente
author_sort EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
collection DOAJ
description Abstract FUMzyme® is an enzyme‐based feed additive intended to degrade fumonisin mycotoxins found as contaminants in feeds for avian species. It is produced from a genetically modified strain of Komagataella pastoris. The additive is already authorised for use with pigs. During the course of this assessment, it was shown that the production strain and its recombinant genes are not present in the final product. Safety for the consumer, the user and the environment were also established. The extension of its use to all avian species is not expected to alter these conclusions. Chickens and turkeys for fattening and laying hens showed no adverse effect when given feed containing 100 times the maximum recommended dose. Consequently, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the additive is safe for poultry when used within the dose range proposed (15–300 U/kg feed) and extends this conclusion to all other avian species. Five short‐term feeding studies were made in which poultry were given feed contaminated with fumonisins with or without the additive. Each included a measure of the concentration of fumonisin B1 and its breakdown products and showed that the enzyme was able to significantly reduce the concentration of fumonisin in faeces and various points in the digestive tract and increase the concentration of the degradation products. In addition, ratio of sphinganine/sphingosine, considered the most sensitive endpoint for fumonisin toxicosis, was significantly reduced by the addition of FUMzyme® at the minimum proposed dose, when added to diets contaminated with fumonisins. FUMzyme® has the capacity to degrade fumonisins in feed, at concentrations below the Guidance limits operating in the EU in chickens and turkeys for fattening and laying hens at the minimum recommended dose of 15 U/kg complete feed. This conclusion can be extrapolated to all avian species.
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spelling doaj.art-ced24c71da1f4cecb753e1a9f56aca362022-12-21T21:32:43ZengWileyEFSA Journal1831-47322016-11-011411n/an/a10.2903/j.efsa.2016.4617Safety and efficacy of fumonisin esterase (FUMzyme®) as a technological feed additive for all avian speciesEFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Guido RychenGabriele AquilinaGiovanna AzimontiVasileios BampidisMaria deLourdes BastosGeorges BoriesAndrew ChessonPier Sandro CocconcelliGerhard FlachowskyJürgen GroppBoris KolarMaryline KoubaMarta López‐AlonsoAlberto MantovaniBaltasar MayoFernando RamosMaria SaarelaRoberto Edoardo VillaRobert John WallacePieter WesterGiovanna MartelliDerek RenshawSecundino López PuenteAbstract FUMzyme® is an enzyme‐based feed additive intended to degrade fumonisin mycotoxins found as contaminants in feeds for avian species. It is produced from a genetically modified strain of Komagataella pastoris. The additive is already authorised for use with pigs. During the course of this assessment, it was shown that the production strain and its recombinant genes are not present in the final product. Safety for the consumer, the user and the environment were also established. The extension of its use to all avian species is not expected to alter these conclusions. Chickens and turkeys for fattening and laying hens showed no adverse effect when given feed containing 100 times the maximum recommended dose. Consequently, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the additive is safe for poultry when used within the dose range proposed (15–300 U/kg feed) and extends this conclusion to all other avian species. Five short‐term feeding studies were made in which poultry were given feed contaminated with fumonisins with or without the additive. Each included a measure of the concentration of fumonisin B1 and its breakdown products and showed that the enzyme was able to significantly reduce the concentration of fumonisin in faeces and various points in the digestive tract and increase the concentration of the degradation products. In addition, ratio of sphinganine/sphingosine, considered the most sensitive endpoint for fumonisin toxicosis, was significantly reduced by the addition of FUMzyme® at the minimum proposed dose, when added to diets contaminated with fumonisins. FUMzyme® has the capacity to degrade fumonisins in feed, at concentrations below the Guidance limits operating in the EU in chickens and turkeys for fattening and laying hens at the minimum recommended dose of 15 U/kg complete feed. This conclusion can be extrapolated to all avian species.https://doi.org/10.2903/j.efsa.2016.4617fumonisin esteraseKomagataella pastorispoultryfumonisin mycotoxinssphinganine/sphingosinesafety
spellingShingle EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Guido Rychen
Gabriele Aquilina
Giovanna Azimonti
Vasileios Bampidis
Maria deLourdes Bastos
Georges Bories
Andrew Chesson
Pier Sandro Cocconcelli
Gerhard Flachowsky
Jürgen Gropp
Boris Kolar
Maryline Kouba
Marta López‐Alonso
Alberto Mantovani
Baltasar Mayo
Fernando Ramos
Maria Saarela
Roberto Edoardo Villa
Robert John Wallace
Pieter Wester
Giovanna Martelli
Derek Renshaw
Secundino López Puente
Safety and efficacy of fumonisin esterase (FUMzyme®) as a technological feed additive for all avian species
EFSA Journal
fumonisin esterase
Komagataella pastoris
poultry
fumonisin mycotoxins
sphinganine/sphingosine
safety
title Safety and efficacy of fumonisin esterase (FUMzyme®) as a technological feed additive for all avian species
title_full Safety and efficacy of fumonisin esterase (FUMzyme®) as a technological feed additive for all avian species
title_fullStr Safety and efficacy of fumonisin esterase (FUMzyme®) as a technological feed additive for all avian species
title_full_unstemmed Safety and efficacy of fumonisin esterase (FUMzyme®) as a technological feed additive for all avian species
title_short Safety and efficacy of fumonisin esterase (FUMzyme®) as a technological feed additive for all avian species
title_sort safety and efficacy of fumonisin esterase fumzyme r as a technological feed additive for all avian species
topic fumonisin esterase
Komagataella pastoris
poultry
fumonisin mycotoxins
sphinganine/sphingosine
safety
url https://doi.org/10.2903/j.efsa.2016.4617
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