Cargando…

Safety and efficacy of Nutrase P (6‐phytase) for chickens for fattening, other poultry for fattening, reared for laying and ornamental birds

Nutrase P is available in powder, granulated, thermostable granulate and liquid forms. It is based on a 6‐phytase produced by a genetically modified strain of K. phaffii. The production strain contains four copies of the ampicillin resistance gene and one copy of a bleomycin resistance gene. Althoug...

Descripción completa

Detalles Bibliográficos
Autores principales: Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Dusemund, Birgit, Kouba, Maryline, Fašmon 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, Cocconcelli, Pier Sandro, Glandorf, Boet, Herman, Lieve, Maradona Prieto, Miguel, Rychen, Guido, Saarela, Maria, Anguita, Montserrat, Galobart, Jaume, Gregoretti, Lucilla, Innocenti, Matteo, Lopez‐Galvez, Gloria, Pettenati, Elisa, Sofianidis, Konstantinos, Brozzi, Rosella, Vettori, Maria Vittoria
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7659520/
https://www.ncbi.nlm.nih.gov/pubmed/33209149
http://dx.doi.org/10.2903/j.efsa.2020.6282
_version_ 1783608839547912192
author Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Kouba, Maryline
Fašmon 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
Cocconcelli, Pier Sandro
Glandorf, Boet
Herman, Lieve
Maradona Prieto, Miguel
Rychen, Guido
Saarela, Maria
Anguita, Montserrat
Galobart, Jaume
Gregoretti, Lucilla
Innocenti, Matteo
Lopez‐Galvez, Gloria
Pettenati, Elisa
Sofianidis, Konstantinos
Brozzi, Rosella
Vettori, Maria Vittoria
author_facet Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Kouba, Maryline
Fašmon 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
Cocconcelli, Pier Sandro
Glandorf, Boet
Herman, Lieve
Maradona Prieto, Miguel
Rychen, Guido
Saarela, Maria
Anguita, Montserrat
Galobart, Jaume
Gregoretti, Lucilla
Innocenti, Matteo
Lopez‐Galvez, Gloria
Pettenati, Elisa
Sofianidis, Konstantinos
Brozzi, Rosella
Vettori, Maria Vittoria
collection PubMed
description Nutrase P is available in powder, granulated, thermostable granulate and liquid forms. It is based on a 6‐phytase produced by a genetically modified strain of K. phaffii. The production strain contains four copies of the ampicillin resistance gene and one copy of a bleomycin resistance gene. Although Nutrase PTS 10,000 (thermostable granulate) and Nutrase PG 10,000 (granulate) do not raise concern regarding the presence of viable cells of the production strain and its recombinant DNA, uncertainties remain on the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder). The FEEDAP Panel cannot conclude on the safety of the additive, in any form, for the target species for which application is made due to major limitations in the study in chickens for fattening provided. Considering the production strain and the results obtained in the genotoxicity studies, the Panel concludes that additive does not pose a toxicological safety concern regarding the consumers of the products obtained from animals receiving the additive. The additive, in its all formulations, is not a skin or eye irritant and is not dermal sensitiser. However, owing to the proteinaceous nature of the active substance it should be considered a respiratory sensitiser. The active substance of the additive is a protein and as such would not raise concerns for the environment. Considering that the production strain harbours AMR genes and there is uncertainties regarding the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder), the Panel cannot conclude on the safety of these two formulations of the additive for the target species, consumer, user and environment. Owing to the lack of data, the FEEDAP Panel cannot conclude on the efficacy of the additive.
format Online
Article
Text
id pubmed-7659520
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher John Wiley and Sons Inc.
record_format MEDLINE/PubMed
spelling pubmed-76595202020-11-17 Safety and efficacy of Nutrase P (6‐phytase) for chickens for fattening, other poultry for fattening, reared for laying and ornamental birds Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Kouba, Maryline Fašmon 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 Cocconcelli, Pier Sandro Glandorf, Boet Herman, Lieve Maradona Prieto, Miguel Rychen, Guido Saarela, Maria Anguita, Montserrat Galobart, Jaume Gregoretti, Lucilla Innocenti, Matteo Lopez‐Galvez, Gloria Pettenati, Elisa Sofianidis, Konstantinos Brozzi, Rosella Vettori, Maria Vittoria EFSA J Scientific Opinion Nutrase P is available in powder, granulated, thermostable granulate and liquid forms. It is based on a 6‐phytase produced by a genetically modified strain of K. phaffii. The production strain contains four copies of the ampicillin resistance gene and one copy of a bleomycin resistance gene. Although Nutrase PTS 10,000 (thermostable granulate) and Nutrase PG 10,000 (granulate) do not raise concern regarding the presence of viable cells of the production strain and its recombinant DNA, uncertainties remain on the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder). The FEEDAP Panel cannot conclude on the safety of the additive, in any form, for the target species for which application is made due to major limitations in the study in chickens for fattening provided. Considering the production strain and the results obtained in the genotoxicity studies, the Panel concludes that additive does not pose a toxicological safety concern regarding the consumers of the products obtained from animals receiving the additive. The additive, in its all formulations, is not a skin or eye irritant and is not dermal sensitiser. However, owing to the proteinaceous nature of the active substance it should be considered a respiratory sensitiser. The active substance of the additive is a protein and as such would not raise concerns for the environment. Considering that the production strain harbours AMR genes and there is uncertainties regarding the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder), the Panel cannot conclude on the safety of these two formulations of the additive for the target species, consumer, user and environment. Owing to the lack of data, the FEEDAP Panel cannot conclude on the efficacy of the additive. John Wiley and Sons Inc. 2020-11-12 /pmc/articles/PMC7659520/ /pubmed/33209149 http://dx.doi.org/10.2903/j.efsa.2020.6282 Text en © 2020 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
Fašmon 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
Cocconcelli, Pier Sandro
Glandorf, Boet
Herman, Lieve
Maradona Prieto, Miguel
Rychen, Guido
Saarela, Maria
Anguita, Montserrat
Galobart, Jaume
Gregoretti, Lucilla
Innocenti, Matteo
Lopez‐Galvez, Gloria
Pettenati, Elisa
Sofianidis, Konstantinos
Brozzi, Rosella
Vettori, Maria Vittoria
Safety and efficacy of Nutrase P (6‐phytase) for chickens for fattening, other poultry for fattening, reared for laying and ornamental birds
title Safety and efficacy of Nutrase P (6‐phytase) for chickens for fattening, other poultry for fattening, reared for laying and ornamental birds
title_full Safety and efficacy of Nutrase P (6‐phytase) for chickens for fattening, other poultry for fattening, reared for laying and ornamental birds
title_fullStr Safety and efficacy of Nutrase P (6‐phytase) for chickens for fattening, other poultry for fattening, reared for laying and ornamental birds
title_full_unstemmed Safety and efficacy of Nutrase P (6‐phytase) for chickens for fattening, other poultry for fattening, reared for laying and ornamental birds
title_short Safety and efficacy of Nutrase P (6‐phytase) for chickens for fattening, other poultry for fattening, reared for laying and ornamental birds
title_sort safety and efficacy of nutrase p (6‐phytase) for chickens for fattening, other poultry for fattening, reared for laying and ornamental birds
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7659520/
https://www.ncbi.nlm.nih.gov/pubmed/33209149
http://dx.doi.org/10.2903/j.efsa.2020.6282
work_keys_str_mv AT safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT bampidisvasileios safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT azimontigiovanna safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT bastosmariadelourdes safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT christensenhenrik safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT dusemundbirgit safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT koubamaryline safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT fasmondurjavamojca safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT lopezalonsomarta safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT lopezpuentesecundino safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT marconfrancesca safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT mayobaltasar safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT pechovaalena safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT petkovamariana safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT ramosfernando safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT sanzyolanda safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT villarobertoedoardo safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT woutersenruud safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT cocconcellipiersandro safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT glandorfboet safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT hermanlieve safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT maradonaprietomiguel safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT rychenguido safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT saarelamaria safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT anguitamontserrat safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT galobartjaume safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT gregorettilucilla safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT innocentimatteo safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT lopezgalvezgloria safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT pettenatielisa safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT sofianidiskonstantinos safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT brozzirosella safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds
AT vettorimariavittoria safetyandefficacyofnutrasep6phytaseforchickensforfatteningotherpoultryforfatteningrearedforlayingandornamentalbirds