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Assessment of the application for renewal of the authorisation of a feed additive consisting of dicopper chloride trihydroxide for all animal species (Nutreco Nederland B.V.)

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 the authorisation of dicopper chloride trihydroxide as a nutritional feed additive. The additive is currently authorised for use in all animal spec...

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Autores principales: Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Dusemund, Birgit, Durjava, Mojca, Kouba, Maryline, López‐Alonso, Marta, Puente, Secundino López, Marcon, Francesca, Mayo, Baltasar, Pechová, Alena, Petkova, Mariana, Ramos, Fernando, Villa, Roberto Edoardo, Woutersen, Ruud, Bories, Georges, Gropp, Jürgen, Galobart, Jaume, Innocenti, Matteo Lorenzo, Ortuño, Jordi, Pizzo, Fabiola, Rossi, Barbara, Tarrés‐Call, Jordi, Vettori, Maria Vittoria, Radovnikovic, Anita
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/PMC10599272/
https://www.ncbi.nlm.nih.gov/pubmed/37886608
http://dx.doi.org/10.2903/j.efsa.2023.8342
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author Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Durjava, Mojca
Kouba, Maryline
López‐Alonso, Marta
Puente, Secundino López
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Villa, Roberto Edoardo
Woutersen, Ruud
Bories, Georges
Gropp, Jürgen
Galobart, Jaume
Innocenti, Matteo Lorenzo
Ortuño, Jordi
Pizzo, Fabiola
Rossi, Barbara
Tarrés‐Call, Jordi
Vettori, Maria Vittoria
Radovnikovic, Anita
author_facet Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Durjava, Mojca
Kouba, Maryline
López‐Alonso, Marta
Puente, Secundino López
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Villa, Roberto Edoardo
Woutersen, Ruud
Bories, Georges
Gropp, Jürgen
Galobart, Jaume
Innocenti, Matteo Lorenzo
Ortuño, Jordi
Pizzo, Fabiola
Rossi, Barbara
Tarrés‐Call, Jordi
Vettori, Maria Vittoria
Radovnikovic, Anita
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 the authorisation of dicopper chloride trihydroxide as a nutritional feed additive. The additive is currently authorised for use in all animal species (3b409). The applicant is requesting a modification in the current authorising specification: (i) replacing the alpha crystal form paratacamite with clinoatacamite; (ii) removing the ratio between crystal polymorphs from the authorising specification; (iii) changing the minimum for particles below 50 μm from 1% to 5%. The FEEDAP Panel considers that the proposed modifications do not introduce concern for the safety for the target species and that the additive remains safe for the target species and the consumers when used up to the maximum authorised levels. Regarding the safety for the environment, the use of the additive in feed for terrestrial animals and land‐based aquaculture is considered safe under the proposed conditions of use. The data available do not allow the FEEDAP Panel to reach a conclusion on the safety of the additive for marine sediment when it is used in sea cages. The additive is not corrosive to skin, but is an eye and skin irritant. Due to the nickel presence, it is considered a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
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spelling pubmed-105992722023-10-26 Assessment of the application for renewal of the authorisation of a feed additive consisting of dicopper chloride trihydroxide for all animal species (Nutreco Nederland B.V.) Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Durjava, Mojca Kouba, Maryline López‐Alonso, Marta Puente, Secundino López Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Villa, Roberto Edoardo Woutersen, Ruud Bories, Georges Gropp, Jürgen Galobart, Jaume Innocenti, Matteo Lorenzo Ortuño, Jordi Pizzo, Fabiola Rossi, Barbara Tarrés‐Call, Jordi Vettori, Maria Vittoria Radovnikovic, Anita 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 the authorisation of dicopper chloride trihydroxide as a nutritional feed additive. The additive is currently authorised for use in all animal species (3b409). The applicant is requesting a modification in the current authorising specification: (i) replacing the alpha crystal form paratacamite with clinoatacamite; (ii) removing the ratio between crystal polymorphs from the authorising specification; (iii) changing the minimum for particles below 50 μm from 1% to 5%. The FEEDAP Panel considers that the proposed modifications do not introduce concern for the safety for the target species and that the additive remains safe for the target species and the consumers when used up to the maximum authorised levels. Regarding the safety for the environment, the use of the additive in feed for terrestrial animals and land‐based aquaculture is considered safe under the proposed conditions of use. The data available do not allow the FEEDAP Panel to reach a conclusion on the safety of the additive for marine sediment when it is used in sea cages. The additive is not corrosive to skin, but is an eye and skin irritant. Due to the nickel presence, it is considered a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. John Wiley and Sons Inc. 2023-10-25 /pmc/articles/PMC10599272/ /pubmed/37886608 http://dx.doi.org/10.2903/j.efsa.2023.8342 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
Kouba, Maryline
López‐Alonso, Marta
Puente, Secundino López
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Villa, Roberto Edoardo
Woutersen, Ruud
Bories, Georges
Gropp, Jürgen
Galobart, Jaume
Innocenti, Matteo Lorenzo
Ortuño, Jordi
Pizzo, Fabiola
Rossi, Barbara
Tarrés‐Call, Jordi
Vettori, Maria Vittoria
Radovnikovic, Anita
Assessment of the application for renewal of the authorisation of a feed additive consisting of dicopper chloride trihydroxide for all animal species (Nutreco Nederland B.V.)
title Assessment of the application for renewal of the authorisation of a feed additive consisting of dicopper chloride trihydroxide for all animal species (Nutreco Nederland B.V.)
title_full Assessment of the application for renewal of the authorisation of a feed additive consisting of dicopper chloride trihydroxide for all animal species (Nutreco Nederland B.V.)
title_fullStr Assessment of the application for renewal of the authorisation of a feed additive consisting of dicopper chloride trihydroxide for all animal species (Nutreco Nederland B.V.)
title_full_unstemmed Assessment of the application for renewal of the authorisation of a feed additive consisting of dicopper chloride trihydroxide for all animal species (Nutreco Nederland B.V.)
title_short Assessment of the application for renewal of the authorisation of a feed additive consisting of dicopper chloride trihydroxide for all animal species (Nutreco Nederland B.V.)
title_sort assessment of the application for renewal of the authorisation of a feed additive consisting of dicopper chloride trihydroxide for all animal species (nutreco nederland b.v.)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10599272/
https://www.ncbi.nlm.nih.gov/pubmed/37886608
http://dx.doi.org/10.2903/j.efsa.2023.8342
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