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Safety and efficacy of Availa(®)Cr (chromium chelate of DL‐methionine) as a feed additive for dairy cows

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Availa(®)Cr (active compound: chromium chelate of DL‐methionine) as a feed additive for dairy cows. The EFSA Panel on Additives and Products or Substances used in Animal Fee...

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Autores principales: Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Dusemund, Birgit, Kos 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, Gropp, Jürgen, Mantovani, Alberto, López‐Gálvez, Gloria
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/PMC7448064/
https://www.ncbi.nlm.nih.gov/pubmed/32874235
http://dx.doi.org/10.2903/j.efsa.2020.6026
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author Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Kos 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
Gropp, Jürgen
Mantovani, Alberto
López‐Gálvez, Gloria
author_facet Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Kos 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
Gropp, Jürgen
Mantovani, Alberto
López‐Gálvez, Gloria
collection PubMed
description Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Availa(®)Cr (active compound: chromium chelate of DL‐methionine) as a feed additive for dairy cows. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel was assigned to this mandate. The tolerance study did not show adverse effects with respect to body weight, milk yield, haematology and blood biochemistry up to the 10‐fold overdose of chromium from Availa(®)Cr; however, owing to deficiencies in design and reporting of the study, it provided only supportive evidence on the safety of the additive. A safe level for dairy cows could be derived from a toxicological study with laboratory rodents. Taking all together, the FEEDAP Panel considers the maximum recommended use level (8 mg Cr from Availa(®)Cr/cow per day; about 0.4 mg Cr/kg complete feed) as safe. Chromium DL‐Met shows a genotoxic activity in vitro that is not expressed in vivo after systemic exposure; although no data on genotoxicity at the site of contact are available, the Panel notes that chromium(III) is not carcinogenic and concludes that chromium DL‐Met is unlikely to pose a carcinogenic risk at levels occurring in the diet. The use of Availa(®)Cr in feed of dairy cows up to the recommended supplementation level would not measurably increase consumer exposure to chromium(III), and therefore is safe for consumers. The additive poses a risk to users by inhalation, it is not an irritant to skin and eyes and should be considered a sensitiser. The use of the additive is not expected to pose a risk to the environment. Since only one study could be considered for the efficacy assessment, and three studies are required, the FEEDAP Panel cannot conclude on the efficacy of Availa(®)Cr for dairy cows.
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spelling pubmed-74480642020-08-31 Safety and efficacy of Availa(®)Cr (chromium chelate of DL‐methionine) as a feed additive for dairy cows Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Kos 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 Gropp, Jürgen Mantovani, Alberto López‐Gálvez, Gloria EFSA J Scientific Opinion Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Availa(®)Cr (active compound: chromium chelate of DL‐methionine) as a feed additive for dairy cows. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel was assigned to this mandate. The tolerance study did not show adverse effects with respect to body weight, milk yield, haematology and blood biochemistry up to the 10‐fold overdose of chromium from Availa(®)Cr; however, owing to deficiencies in design and reporting of the study, it provided only supportive evidence on the safety of the additive. A safe level for dairy cows could be derived from a toxicological study with laboratory rodents. Taking all together, the FEEDAP Panel considers the maximum recommended use level (8 mg Cr from Availa(®)Cr/cow per day; about 0.4 mg Cr/kg complete feed) as safe. Chromium DL‐Met shows a genotoxic activity in vitro that is not expressed in vivo after systemic exposure; although no data on genotoxicity at the site of contact are available, the Panel notes that chromium(III) is not carcinogenic and concludes that chromium DL‐Met is unlikely to pose a carcinogenic risk at levels occurring in the diet. The use of Availa(®)Cr in feed of dairy cows up to the recommended supplementation level would not measurably increase consumer exposure to chromium(III), and therefore is safe for consumers. The additive poses a risk to users by inhalation, it is not an irritant to skin and eyes and should be considered a sensitiser. The use of the additive is not expected to pose a risk to the environment. Since only one study could be considered for the efficacy assessment, and three studies are required, the FEEDAP Panel cannot conclude on the efficacy of Availa(®)Cr for dairy cows. John Wiley and Sons Inc. 2020-02-26 /pmc/articles/PMC7448064/ /pubmed/32874235 http://dx.doi.org/10.2903/j.efsa.2020.6026 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
Kos 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
Gropp, Jürgen
Mantovani, Alberto
López‐Gálvez, Gloria
Safety and efficacy of Availa(®)Cr (chromium chelate of DL‐methionine) as a feed additive for dairy cows
title Safety and efficacy of Availa(®)Cr (chromium chelate of DL‐methionine) as a feed additive for dairy cows
title_full Safety and efficacy of Availa(®)Cr (chromium chelate of DL‐methionine) as a feed additive for dairy cows
title_fullStr Safety and efficacy of Availa(®)Cr (chromium chelate of DL‐methionine) as a feed additive for dairy cows
title_full_unstemmed Safety and efficacy of Availa(®)Cr (chromium chelate of DL‐methionine) as a feed additive for dairy cows
title_short Safety and efficacy of Availa(®)Cr (chromium chelate of DL‐methionine) as a feed additive for dairy cows
title_sort safety and efficacy of availa(®)cr (chromium chelate of dl‐methionine) as a feed additive for dairy cows
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448064/
https://www.ncbi.nlm.nih.gov/pubmed/32874235
http://dx.doi.org/10.2903/j.efsa.2020.6026
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