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Safety and efficacy of fumonisin esterase from Komagataella phaffii DSM 32159 as a feed additive for all animal species
Author(s) -
Bampidis Vasileios,
Azimonti Giovanna,
Bastos Maria de Lourdes,
Christensen Henrik,
Dusemund Birgit,
Kos Durjava Mojca,
Kouba Maryline,
LópezAlonso Marta,
López Puente Secundino,
Marcon Francesca,
Mayo Baltasar,
Pechová Alena,
Petkova Mariana,
Ramos Fernando,
Sanz Yolanda,
Villa Roberto Edoardo,
Woutersen Ruud,
Brozzi Rosella,
Galobart Jaume,
Gregoretti Lucilla,
Innocenti Matteo L.,
Sofianidis Konstantinos,
Vettori Maria Vittoria,
LópezGálvez Gloria
Publication year - 2020
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2020.6207
Subject(s) - feed additive , mycotoxin , animal feed , fumonisin , biology , european union , food science , microbiology and biotechnology , fumonisin b1 , genetically modified organism , european commission , toxicology , business , biochemistry , broiler , gene , economic policy
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed ( FEEDAP ) was asked to deliver a scientific opinion on the safety and efficacy of fumonisin esterase from Komagataella phaffii DSM 32159 as a technological feed additive for all animal species. The product has been already assessed by the FEEDAP Panel for use in pigs and poultry feed as technological additive and was granted with an authorisation in the EU for this use. In the current application, the additive is intended to be used in fermenting feeds with the purpose to reduce the contamination of feed by fumonisins. New data provided showed that no recombinant DNA could be detected in three batches of the product. The evidence provided – based on the data submitted in the previous and the current application – allowed the FEEDAP Panel to conclude that the additive is safe for the target animals under the proposed conditions of use. The Panel also considered valid the previous conclusions in which the safety of the additive for consumers and the environment was established. The additive is not toxic by inhalation and the respiratory exposure is likely to be low; however, a risk of sensitisation via the respiratory route cannot be excluded. The additive is non‐irritant to skin and eyes and is not considered as a dermal sensitiser. The additive has the capacity to degrade fumonisins in fermenting feed (with a fumonisin content within the guidance limits operating in the EU ) when used at the minimum recommended dose of 40 U/kg feed. The FEEDAP Panel notes that the efficacy has been demonstrated only in silages, not in other fermenting feeds like e.g. liquid feeds.

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