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Assessment of the feed additive consisting of ammonium chloride (Amoklor™) for all ruminants, dogs and cats for the renewal of its authorisation and its extension of use to sows (Latochema Co Ltd)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of authorisation of ammonium chloride (Amoklor™) as a zootechnical additive for all ruminants, dogs and cats and its extension of use in sows for urin...

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Autores principales: Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Dusemund, Birgit, Fašmon Durjava, Mojca, 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, Dierick, Noël, Anguita, Montserrat, Brozzi, Rosella, Galobart, Jaume, Holczknecht, Orsolya, Innocenti, Matteo Lorenzo, Manini, Paola, Navarro‐Villa, Alberto, Pizzo, Fabiola, Radovnikovic, Anita, Rossi, Barbara, Vettori, Maria Vittoria, Amaduzzi, Angelica
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/PMC9832324/
https://www.ncbi.nlm.nih.gov/pubmed/36643906
http://dx.doi.org/10.2903/j.efsa.2023.7696
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author Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Fašmon Durjava, Mojca
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
Dierick, Noël
Anguita, Montserrat
Brozzi, Rosella
Galobart, Jaume
Holczknecht, Orsolya
Innocenti, Matteo Lorenzo
Manini, Paola
Navarro‐Villa, Alberto
Pizzo, Fabiola
Radovnikovic, Anita
Rossi, Barbara
Vettori, Maria Vittoria
Amaduzzi, Angelica
author_facet Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Fašmon Durjava, Mojca
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
Dierick, Noël
Anguita, Montserrat
Brozzi, Rosella
Galobart, Jaume
Holczknecht, Orsolya
Innocenti, Matteo Lorenzo
Manini, Paola
Navarro‐Villa, Alberto
Pizzo, Fabiola
Radovnikovic, Anita
Rossi, Barbara
Vettori, Maria Vittoria
Amaduzzi, Angelica
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 the renewal of authorisation of ammonium chloride (Amoklor™) as a zootechnical additive for all ruminants, dogs and cats and its extension of use in sows for urinary health. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for ruminants other than lambs for fattening, lambs for fattening, cats and dogs, consumers and the environment under the current authorised conditions of use. Inhalation exposure of the additive is considered very likely. Amoklor™ should be considered a potential respiratory sensitiser but not a skin sensitiser. The additive is not irritant to the skin, but the Panel could not conclude on its eye irritation potential. The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. Regarding the extension of use in sows, the FEEDAP Panel concludes that the additive is safe and efficacious for sows at the inclusion level of 5,000 mg/kg feedingstuffs from week 9th to 11th of gestation and from week 15th of gestation to 1st of lactation.
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spelling pubmed-98323242023-01-12 Assessment of the feed additive consisting of ammonium chloride (Amoklor™) for all ruminants, dogs and cats for the renewal of its authorisation and its extension of use to sows (Latochema Co Ltd) Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Fašmon Durjava, Mojca 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 Dierick, Noël Anguita, Montserrat Brozzi, Rosella Galobart, Jaume Holczknecht, Orsolya Innocenti, Matteo Lorenzo Manini, Paola Navarro‐Villa, Alberto Pizzo, Fabiola Radovnikovic, Anita Rossi, Barbara Vettori, Maria Vittoria Amaduzzi, Angelica 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 the renewal of authorisation of ammonium chloride (Amoklor™) as a zootechnical additive for all ruminants, dogs and cats and its extension of use in sows for urinary health. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for ruminants other than lambs for fattening, lambs for fattening, cats and dogs, consumers and the environment under the current authorised conditions of use. Inhalation exposure of the additive is considered very likely. Amoklor™ should be considered a potential respiratory sensitiser but not a skin sensitiser. The additive is not irritant to the skin, but the Panel could not conclude on its eye irritation potential. The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. Regarding the extension of use in sows, the FEEDAP Panel concludes that the additive is safe and efficacious for sows at the inclusion level of 5,000 mg/kg feedingstuffs from week 9th to 11th of gestation and from week 15th of gestation to 1st of lactation. John Wiley and Sons Inc. 2023-01-11 /pmc/articles/PMC9832324/ /pubmed/36643906 http://dx.doi.org/10.2903/j.efsa.2023.7696 Text en © 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the 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
Fašmon Durjava, Mojca
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
Dierick, Noël
Anguita, Montserrat
Brozzi, Rosella
Galobart, Jaume
Holczknecht, Orsolya
Innocenti, Matteo Lorenzo
Manini, Paola
Navarro‐Villa, Alberto
Pizzo, Fabiola
Radovnikovic, Anita
Rossi, Barbara
Vettori, Maria Vittoria
Amaduzzi, Angelica
Assessment of the feed additive consisting of ammonium chloride (Amoklor™) for all ruminants, dogs and cats for the renewal of its authorisation and its extension of use to sows (Latochema Co Ltd)
title Assessment of the feed additive consisting of ammonium chloride (Amoklor™) for all ruminants, dogs and cats for the renewal of its authorisation and its extension of use to sows (Latochema Co Ltd)
title_full Assessment of the feed additive consisting of ammonium chloride (Amoklor™) for all ruminants, dogs and cats for the renewal of its authorisation and its extension of use to sows (Latochema Co Ltd)
title_fullStr Assessment of the feed additive consisting of ammonium chloride (Amoklor™) for all ruminants, dogs and cats for the renewal of its authorisation and its extension of use to sows (Latochema Co Ltd)
title_full_unstemmed Assessment of the feed additive consisting of ammonium chloride (Amoklor™) for all ruminants, dogs and cats for the renewal of its authorisation and its extension of use to sows (Latochema Co Ltd)
title_short Assessment of the feed additive consisting of ammonium chloride (Amoklor™) for all ruminants, dogs and cats for the renewal of its authorisation and its extension of use to sows (Latochema Co Ltd)
title_sort assessment of the feed additive consisting of ammonium chloride (amoklor™) for all ruminants, dogs and cats for the renewal of its authorisation and its extension of use to sows (latochema co ltd)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9832324/
https://www.ncbi.nlm.nih.gov/pubmed/36643906
http://dx.doi.org/10.2903/j.efsa.2023.7696
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