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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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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. |
format | Online Article Text |
id | pubmed-7448064 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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