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Safety and efficacy of APSA PHYTAFEED (®) 20,000 GR/L (6‐phytase) as a feed additive for piglets (suckling and weaned) and growing minor porcine species

Following a request from the European Commission, the EFSA 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 APSA PHYTAFEED (®) 20,000 GR/L (6‐phytase) as a feed additive for piglets and growing minor po...

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Autores principales: Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Dusemund, Birgit, Kouba, Maryline, Kos Durjava, Mojca, López‐Alonso, Marta, López Puente, Secundino, Marcon, Francesca, Mayo, Baltasar, Pechová, Alena, Petkova, Mariana, Ramos, Fernando, Sanz, Yolanda, Villa, Roberto Edoardo, Woutersen, Ruud, Galobart, Jaume, Holczknecht, Orsolya, Manini, Paola, Pizzo, Fabiola, Call, Jordi Tarrés, Anguita, Montserrat
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008879/
https://www.ncbi.nlm.nih.gov/pubmed/32626179
http://dx.doi.org/10.2903/j.efsa.2019.5894
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author Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Kouba, Maryline
Kos Durjava, Mojca
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Galobart, Jaume
Holczknecht, Orsolya
Manini, Paola
Pizzo, Fabiola
Call, Jordi Tarrés
Anguita, Montserrat
author_facet Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Kouba, Maryline
Kos Durjava, Mojca
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Galobart, Jaume
Holczknecht, Orsolya
Manini, Paola
Pizzo, Fabiola
Call, Jordi Tarrés
Anguita, Montserrat
collection PubMed
description Following a request from the European Commission, the EFSA 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 APSA PHYTAFEED (®) 20,000 GR/L (6‐phytase) as a feed additive for piglets and growing minor porcine species. The additive is a preparation of 6‐phytase produced by a genetically modified strain of Komagataella phaffii and has been previously assessed by the FEEDAP Panel in the context of an application for its use in feed for chickens for fattening. The Panel concluded in that opinion that the production strain is safe, and that the use of the additive as a feed additive would raise no safety concerns for the consumers and the environment. The additive was also considered not to be irritant to skin or eyes or a dermal sensitiser but that should be considered as a respiratory sensitiser. The Panel considered that the new use in piglets would not modify the previously drawn conclusions with respect to the consumers, users and the environment. A tolerance trial and a subchronic oral toxicity study were made available to support the safety for the new target species. From the results obtained, the Panel concluded that the additive is safe for piglets (suckling and weaned) and for growing minor porcine species at the recommended enzyme activity of 250 U/kg feed with a wide margin of safety. The applicant submitted three efficacy trials to support the efficacy of the additive. In the trials, the apparent faecal digestibility of phosphorus and bone ash/phosphorus content were measured. From the results obtained, the FEEDAP Panel concluded that APSA PHYTAFEED (®) GR/L is efficacious for piglets (suckling and weaned) and for growing minor porcine species at an enzyme activity of 1,000 U/kg feed.
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spelling pubmed-70088792020-07-02 Safety and efficacy of APSA PHYTAFEED (®) 20,000 GR/L (6‐phytase) as a feed additive for piglets (suckling and weaned) and growing minor porcine species Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Kouba, Maryline Kos Durjava, Mojca López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Galobart, Jaume Holczknecht, Orsolya Manini, Paola Pizzo, Fabiola Call, Jordi Tarrés Anguita, Montserrat EFSA J Scientific Opinion Following a request from the European Commission, the EFSA 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 APSA PHYTAFEED (®) 20,000 GR/L (6‐phytase) as a feed additive for piglets and growing minor porcine species. The additive is a preparation of 6‐phytase produced by a genetically modified strain of Komagataella phaffii and has been previously assessed by the FEEDAP Panel in the context of an application for its use in feed for chickens for fattening. The Panel concluded in that opinion that the production strain is safe, and that the use of the additive as a feed additive would raise no safety concerns for the consumers and the environment. The additive was also considered not to be irritant to skin or eyes or a dermal sensitiser but that should be considered as a respiratory sensitiser. The Panel considered that the new use in piglets would not modify the previously drawn conclusions with respect to the consumers, users and the environment. A tolerance trial and a subchronic oral toxicity study were made available to support the safety for the new target species. From the results obtained, the Panel concluded that the additive is safe for piglets (suckling and weaned) and for growing minor porcine species at the recommended enzyme activity of 250 U/kg feed with a wide margin of safety. The applicant submitted three efficacy trials to support the efficacy of the additive. In the trials, the apparent faecal digestibility of phosphorus and bone ash/phosphorus content were measured. From the results obtained, the FEEDAP Panel concluded that APSA PHYTAFEED (®) GR/L is efficacious for piglets (suckling and weaned) and for growing minor porcine species at an enzyme activity of 1,000 U/kg feed. John Wiley and Sons Inc. 2019-11-13 /pmc/articles/PMC7008879/ /pubmed/32626179 http://dx.doi.org/10.2903/j.efsa.2019.5894 Text en © 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
spellingShingle Scientific Opinion
Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Kouba, Maryline
Kos Durjava, Mojca
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Galobart, Jaume
Holczknecht, Orsolya
Manini, Paola
Pizzo, Fabiola
Call, Jordi Tarrés
Anguita, Montserrat
Safety and efficacy of APSA PHYTAFEED (®) 20,000 GR/L (6‐phytase) as a feed additive for piglets (suckling and weaned) and growing minor porcine species
title Safety and efficacy of APSA PHYTAFEED (®) 20,000 GR/L (6‐phytase) as a feed additive for piglets (suckling and weaned) and growing minor porcine species
title_full Safety and efficacy of APSA PHYTAFEED (®) 20,000 GR/L (6‐phytase) as a feed additive for piglets (suckling and weaned) and growing minor porcine species
title_fullStr Safety and efficacy of APSA PHYTAFEED (®) 20,000 GR/L (6‐phytase) as a feed additive for piglets (suckling and weaned) and growing minor porcine species
title_full_unstemmed Safety and efficacy of APSA PHYTAFEED (®) 20,000 GR/L (6‐phytase) as a feed additive for piglets (suckling and weaned) and growing minor porcine species
title_short Safety and efficacy of APSA PHYTAFEED (®) 20,000 GR/L (6‐phytase) as a feed additive for piglets (suckling and weaned) and growing minor porcine species
title_sort safety and efficacy of apsa phytafeed (®) 20,000 gr/l (6‐phytase) as a feed additive for piglets (suckling and weaned) and growing minor porcine species
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008879/
https://www.ncbi.nlm.nih.gov/pubmed/32626179
http://dx.doi.org/10.2903/j.efsa.2019.5894
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