Assessment of the feed additive consisting of sodium benzoate (Protural®) for weaned piglets for the renewal of its authorisation and the extension of use to other growing Suidae (Taminco Finland Oy)

Abstract 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 Protural® (sodium benzoate) when used as a zootechnical additive in feed for weaned piglet...

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Autores principales:	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Fašmon Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa, Ruud Woutersen, Montserrat Anguita, Jaume Galobart, Fabiola Pizzo
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	Protural sodium benzoate weaned piglets other growing Suidae renewal extension of use Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
Acceso en línea:	https://doaj.org/article/30e1e06a85c843528a1bca0c946afee0
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spelling	oai:doaj.org-article:30e1e06a85c843528a1bca0c946afee02021-12-02T17:55:57ZAssessment of the feed additive consisting of sodium benzoate (Protural®) for weaned piglets for the renewal of its authorisation and the extension of use to other growing Suidae (Taminco Finland Oy)1831-473210.2903/j.efsa.2021.6899https://doaj.org/article/30e1e06a85c843528a1bca0c946afee02021-11-01T00:00:00Zhttps://doi.org/10.2903/j.efsa.2021.6899https://doaj.org/toc/1831-4732Abstract 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 Protural® (sodium benzoate) when used as a zootechnical additive in feed for weaned piglets and other growing Suidae at 4,000 mg/kg feedingstuff. Protural® consists of sodium benzoate without any carrier materials and is currently authorised for use in weaned piglets. This opinion concerns the renewal of the authorisation of Protural® for weaned piglets and the evaluation of the new use in other growing Suidae. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The FEEDAP Panel concluded that Protural® is safe under the current conditions of authorisation for the target species, consumers of products from animals fed the additive and the environment. Protural® was not considered as irritant to skin and eyes but a skin sensitiser. Based on dusting potential data, the FEEDAP Panel considered that the powder formulation of the additive represented a risk by inhalation. There was no need for assessing the efficacy of Protural® in the context of the renewal of the authorisation for weaned piglets. The efficacy data previously evaluated allowed the FEEDAP Panel to conclude that the additive has the potential to be efficacious at the level of 4,000 mg/kg feedingstuff in other growing Suidae. A conclusion cannot be reached for the efficacy in pigs for fattening.EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMojca Fašmon DurjavaMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosYolanda SanzRoberto Edoardo VillaRuud WoutersenMontserrat AnguitaJaume GalobartFabiola PizzoWileyarticleProturalsodium benzoateweaned pigletsother growing Suidaerenewalextension of useNutrition. Foods and food supplyTX341-641Chemical technologyTP1-1185ENEFSA Journal, Vol 19, Iss 11, Pp n/a-n/a (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Protural sodium benzoate weaned piglets other growing Suidae renewal extension of use Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
spellingShingle	Protural sodium benzoate weaned piglets other growing Suidae renewal extension of use Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Montserrat Anguita Jaume Galobart Fabiola Pizzo Assessment of the feed additive consisting of sodium benzoate (Protural®) for weaned piglets for the renewal of its authorisation and the extension of use to other growing Suidae (Taminco Finland Oy)
description	Abstract 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 Protural® (sodium benzoate) when used as a zootechnical additive in feed for weaned piglets and other growing Suidae at 4,000 mg/kg feedingstuff. Protural® consists of sodium benzoate without any carrier materials and is currently authorised for use in weaned piglets. This opinion concerns the renewal of the authorisation of Protural® for weaned piglets and the evaluation of the new use in other growing Suidae. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The FEEDAP Panel concluded that Protural® is safe under the current conditions of authorisation for the target species, consumers of products from animals fed the additive and the environment. Protural® was not considered as irritant to skin and eyes but a skin sensitiser. Based on dusting potential data, the FEEDAP Panel considered that the powder formulation of the additive represented a risk by inhalation. There was no need for assessing the efficacy of Protural® in the context of the renewal of the authorisation for weaned piglets. The efficacy data previously evaluated allowed the FEEDAP Panel to conclude that the additive has the potential to be efficacious at the level of 4,000 mg/kg feedingstuff in other growing Suidae. A conclusion cannot be reached for the efficacy in pigs for fattening.
format	article
author	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Montserrat Anguita Jaume Galobart Fabiola Pizzo
author_facet	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Montserrat Anguita Jaume Galobart Fabiola Pizzo
author_sort	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
title	Assessment of the feed additive consisting of sodium benzoate (Protural®) for weaned piglets for the renewal of its authorisation and the extension of use to other growing Suidae (Taminco Finland Oy)
title_short	Assessment of the feed additive consisting of sodium benzoate (Protural®) for weaned piglets for the renewal of its authorisation and the extension of use to other growing Suidae (Taminco Finland Oy)
title_full	Assessment of the feed additive consisting of sodium benzoate (Protural®) for weaned piglets for the renewal of its authorisation and the extension of use to other growing Suidae (Taminco Finland Oy)
title_fullStr	Assessment of the feed additive consisting of sodium benzoate (Protural®) for weaned piglets for the renewal of its authorisation and the extension of use to other growing Suidae (Taminco Finland Oy)
title_full_unstemmed	Assessment of the feed additive consisting of sodium benzoate (Protural®) for weaned piglets for the renewal of its authorisation and the extension of use to other growing Suidae (Taminco Finland Oy)
title_sort	assessment of the feed additive consisting of sodium benzoate (protural®) for weaned piglets for the renewal of its authorisation and the extension of use to other growing suidae (taminco finland oy)
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/30e1e06a85c843528a1bca0c946afee0
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Assessment of the feed additive consisting of sodium benzoate (Protural®) for weaned piglets for the renewal of its authorisation and the extension of use to other growing Suidae (Taminco Finland Oy)

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