Cargando…

Safety and efficacy of a feed additive consisting of 25‐hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008 for pigs and poultry for the renewal of its authorisation (DSM Nutritional Products Sp. z.o.o)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of 25‐hydroxycholecalciferol as a feed additive for pigs and poultry. The applicant provided data demonstrating that the additive current...

Descripción completa

Detalles Bibliográficos
Autores principales: Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Dusemund, Birgit, Durjava, Mojca Fašmon, Kouba, Maryline, López‐Alonso, Marta, López Puente, Secundino, Marcon, Francesca, Mayo, Baltasar, Pechová, Alena, Petkova, Mariana, Ramos, Fernando, Sanz, Yolanda, Villa, Roberto Edoardo, Woutersen, Ruud, Gropp, Jürgen, Anguita, Montserrat, Pizzo, Fabiola, Pettenati, Elisa, Vettori, Maria Vittoria, Tarrés‐Call, Jordi, Galobart, Jaume
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10410499/
https://www.ncbi.nlm.nih.gov/pubmed/37564190
http://dx.doi.org/10.2903/j.efsa.2023.8168
_version_ 1785086472155561984
author Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Durjava, Mojca Fašmon
Kouba, Maryline
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Gropp, Jürgen
Anguita, Montserrat
Pizzo, Fabiola
Pettenati, Elisa
Vettori, Maria Vittoria
Tarrés‐Call, Jordi
Galobart, Jaume
author_facet Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Durjava, Mojca Fašmon
Kouba, Maryline
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Gropp, Jürgen
Anguita, Montserrat
Pizzo, Fabiola
Pettenati, Elisa
Vettori, Maria Vittoria
Tarrés‐Call, Jordi
Galobart, Jaume
collection PubMed
description Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of 25‐hydroxycholecalciferol as a feed additive for pigs and poultry. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the additive does not give raise to any safety concern regarding the production strain. Considering that the manufacturing process, the composition of the additive and its conditions of use have not been modified, the Panel considers that there is no evidence to reconsider the conclusions reached in the previous assessments. Therefore, the Panel concludes that 25‐OH‐D(3) remains safe for the target species, the consumer and the environment under the existing conditions of the authorisation. The additive is not irritant to the skin or eyes but no conclusion on its potential to be a skin sensitiser or on its effects on the respiratory system can be reached due to absence of data. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation.
format Online
Article
Text
id pubmed-10410499
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher John Wiley and Sons Inc.
record_format MEDLINE/PubMed
spelling pubmed-104104992023-08-10 Safety and efficacy of a feed additive consisting of 25‐hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008 for pigs and poultry for the renewal of its authorisation (DSM Nutritional Products Sp. z.o.o) Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Durjava, Mojca Fašmon Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Gropp, Jürgen Anguita, Montserrat Pizzo, Fabiola Pettenati, Elisa Vettori, Maria Vittoria Tarrés‐Call, Jordi Galobart, Jaume EFSA J Scientific Opinion Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of 25‐hydroxycholecalciferol as a feed additive for pigs and poultry. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the additive does not give raise to any safety concern regarding the production strain. Considering that the manufacturing process, the composition of the additive and its conditions of use have not been modified, the Panel considers that there is no evidence to reconsider the conclusions reached in the previous assessments. Therefore, the Panel concludes that 25‐OH‐D(3) remains safe for the target species, the consumer and the environment under the existing conditions of the authorisation. The additive is not irritant to the skin or eyes but no conclusion on its potential to be a skin sensitiser or on its effects on the respiratory system can be reached due to absence of data. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation. John Wiley and Sons Inc. 2023-08-09 /pmc/articles/PMC10410499/ /pubmed/37564190 http://dx.doi.org/10.2903/j.efsa.2023.8168 Text en © 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://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
Durjava, Mojca Fašmon
Kouba, Maryline
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Gropp, Jürgen
Anguita, Montserrat
Pizzo, Fabiola
Pettenati, Elisa
Vettori, Maria Vittoria
Tarrés‐Call, Jordi
Galobart, Jaume
Safety and efficacy of a feed additive consisting of 25‐hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008 for pigs and poultry for the renewal of its authorisation (DSM Nutritional Products Sp. z.o.o)
title Safety and efficacy of a feed additive consisting of 25‐hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008 for pigs and poultry for the renewal of its authorisation (DSM Nutritional Products Sp. z.o.o)
title_full Safety and efficacy of a feed additive consisting of 25‐hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008 for pigs and poultry for the renewal of its authorisation (DSM Nutritional Products Sp. z.o.o)
title_fullStr Safety and efficacy of a feed additive consisting of 25‐hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008 for pigs and poultry for the renewal of its authorisation (DSM Nutritional Products Sp. z.o.o)
title_full_unstemmed Safety and efficacy of a feed additive consisting of 25‐hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008 for pigs and poultry for the renewal of its authorisation (DSM Nutritional Products Sp. z.o.o)
title_short Safety and efficacy of a feed additive consisting of 25‐hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008 for pigs and poultry for the renewal of its authorisation (DSM Nutritional Products Sp. z.o.o)
title_sort safety and efficacy of a feed additive consisting of 25‐hydroxycholecalciferol produced with saccharomyces cerevisiae cbs 146008 for pigs and poultry for the renewal of its authorisation (dsm nutritional products sp. z.o.o)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10410499/
https://www.ncbi.nlm.nih.gov/pubmed/37564190
http://dx.doi.org/10.2903/j.efsa.2023.8168
work_keys_str_mv AT safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT bampidisvasileios safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT azimontigiovanna safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT bastosmariadelourdes safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT christensenhenrik safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT dusemundbirgit safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT durjavamojcafasmon safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT koubamaryline safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT lopezalonsomarta safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT lopezpuentesecundino safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT marconfrancesca safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT mayobaltasar safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT pechovaalena safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT petkovamariana safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT ramosfernando safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT sanzyolanda safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT villarobertoedoardo safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT woutersenruud safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT groppjurgen safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT anguitamontserrat safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT pizzofabiola safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT pettenatielisa safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT vettorimariavittoria safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT tarrescalljordi safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo
AT galobartjaume safetyandefficacyofafeedadditiveconsistingof25hydroxycholecalciferolproducedwithsaccharomycescerevisiaecbs146008forpigsandpoultryfortherenewalofitsauthorisationdsmnutritionalproductsspzoo