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Safety and efficacy of Kelforce(®) (l‐glutamic acid, N,N‐diacetic acid, tetrasodium salt (GLDA‐Na(4))) as a feed additive for chickens for fattening

l‐Glutamic acid, N,N‐diacetic acid, tetrasodium salt (GLDA‐Na(4)) (Kelforce(®)) is sought to be used as a zootechnical feed additive in chickens for fattening to improve the absorption of zinc from feed, reducing zinc emissions through manure and thus, affecting favourably the environment. The produ...

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Autores principales: Rychen, Guido, Aquilina, Gabriele, Azimonti, Giovanna, Bampidis, Vasileios, Bastos, Maria de Lourdes, Bories, Georges, Chesson, Andrew, Cocconcelli, Pier Sandro, Flachowsky, Gerhard, Gropp, Jürgen, Kolar, Boris, Kouba, Maryline, López‐Alonso, Marta, López Puente, Secundino, Mayo, Baltasar, Ramos, Fernando, Saarela, Maria, Villa, Roberto Edoardo, Wallace, Robert John, Wester, Pieter, Martelli, Giovanna, Renshaw, Derek, López‐Gálvez, Gloria, Mantovani, Alberto
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009609/
https://www.ncbi.nlm.nih.gov/pubmed/32625916
http://dx.doi.org/10.2903/j.efsa.2018.5279
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author Rychen, Guido
Aquilina, Gabriele
Azimonti, Giovanna
Bampidis, Vasileios
Bastos, Maria de Lourdes
Bories, Georges
Chesson, Andrew
Cocconcelli, Pier Sandro
Flachowsky, Gerhard
Gropp, Jürgen
Kolar, Boris
Kouba, Maryline
López‐Alonso, Marta
López Puente, Secundino
Mayo, Baltasar
Ramos, Fernando
Saarela, Maria
Villa, Roberto Edoardo
Wallace, Robert John
Wester, Pieter
Martelli, Giovanna
Renshaw, Derek
López‐Gálvez, Gloria
Mantovani, Alberto
author_facet Rychen, Guido
Aquilina, Gabriele
Azimonti, Giovanna
Bampidis, Vasileios
Bastos, Maria de Lourdes
Bories, Georges
Chesson, Andrew
Cocconcelli, Pier Sandro
Flachowsky, Gerhard
Gropp, Jürgen
Kolar, Boris
Kouba, Maryline
López‐Alonso, Marta
López Puente, Secundino
Mayo, Baltasar
Ramos, Fernando
Saarela, Maria
Villa, Roberto Edoardo
Wallace, Robert John
Wester, Pieter
Martelli, Giovanna
Renshaw, Derek
López‐Gálvez, Gloria
Mantovani, Alberto
collection PubMed
description l‐Glutamic acid, N,N‐diacetic acid, tetrasodium salt (GLDA‐Na(4)) (Kelforce(®)) is sought to be used as a zootechnical feed additive in chickens for fattening to improve the absorption of zinc from feed, reducing zinc emissions through manure and thus, affecting favourably the environment. The product has not been authorised in the European Union as a feed additive. Kelforce(®) is intended to be marketed as a liquid and solid formulation, containing ≥ 47% and ≥ 30% of GLDA‐Na(4), respectively. Kelforce(®) is safe for chickens for fattening at the maximum level of 1,000 mg GLDA‐Na(4)/kg complete feed. Based on the toxicological profile of GLDA‐Na(4) and the consumer exposure to GLDA‐Na(4) and to nitrilotriacetic acid trisodium salt (NTA‐Na(3); an impurity of the additive), the use of Kelforce(®) at the maximum proposed level in feed of chickens for fattening is of no concern for consumer safety. Due to its low inhalation toxicity, the exposure to GLDA‐Na(4) is unlikely to pose a risk by inhalation. However, owing to the high‐dusting potential of the solid formulation, a risk from such high level of dust, even if toxicologically inert, cannot be excluded. Kelforce(®) is not a skin/eye irritant or skin sensitiser. No risks for the terrestrial compartment were identified at the maximum use level of the additive. Risks for the aquatic compartment cannot be excluded based on the secondary effect of the additive on green algae. In the absence of data, the Panel cannot conclude on the safety for the sediment compartment or the possible ground water contamination. The risk of bioaccumulation and secondary poisoning caused by the additive is considered very low. Owing to the inconsistent and conflicting results from the studies assessed, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot conclude on the efficacy of the additive. The Panel made a recommendation regarding the levels of formaldehyde and cyanide in the active substance.
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spelling pubmed-70096092020-07-02 Safety and efficacy of Kelforce(®) (l‐glutamic acid, N,N‐diacetic acid, tetrasodium salt (GLDA‐Na(4))) as a feed additive for chickens for fattening Rychen, Guido Aquilina, Gabriele Azimonti, Giovanna Bampidis, Vasileios Bastos, Maria de Lourdes Bories, Georges Chesson, Andrew Cocconcelli, Pier Sandro Flachowsky, Gerhard Gropp, Jürgen Kolar, Boris Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Mayo, Baltasar Ramos, Fernando Saarela, Maria Villa, Roberto Edoardo Wallace, Robert John Wester, Pieter Martelli, Giovanna Renshaw, Derek López‐Gálvez, Gloria Mantovani, Alberto EFSA J Scientific Opinion l‐Glutamic acid, N,N‐diacetic acid, tetrasodium salt (GLDA‐Na(4)) (Kelforce(®)) is sought to be used as a zootechnical feed additive in chickens for fattening to improve the absorption of zinc from feed, reducing zinc emissions through manure and thus, affecting favourably the environment. The product has not been authorised in the European Union as a feed additive. Kelforce(®) is intended to be marketed as a liquid and solid formulation, containing ≥ 47% and ≥ 30% of GLDA‐Na(4), respectively. Kelforce(®) is safe for chickens for fattening at the maximum level of 1,000 mg GLDA‐Na(4)/kg complete feed. Based on the toxicological profile of GLDA‐Na(4) and the consumer exposure to GLDA‐Na(4) and to nitrilotriacetic acid trisodium salt (NTA‐Na(3); an impurity of the additive), the use of Kelforce(®) at the maximum proposed level in feed of chickens for fattening is of no concern for consumer safety. Due to its low inhalation toxicity, the exposure to GLDA‐Na(4) is unlikely to pose a risk by inhalation. However, owing to the high‐dusting potential of the solid formulation, a risk from such high level of dust, even if toxicologically inert, cannot be excluded. Kelforce(®) is not a skin/eye irritant or skin sensitiser. No risks for the terrestrial compartment were identified at the maximum use level of the additive. Risks for the aquatic compartment cannot be excluded based on the secondary effect of the additive on green algae. In the absence of data, the Panel cannot conclude on the safety for the sediment compartment or the possible ground water contamination. The risk of bioaccumulation and secondary poisoning caused by the additive is considered very low. Owing to the inconsistent and conflicting results from the studies assessed, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot conclude on the efficacy of the additive. The Panel made a recommendation regarding the levels of formaldehyde and cyanide in the active substance. John Wiley and Sons Inc. 2018-05-18 /pmc/articles/PMC7009609/ /pubmed/32625916 http://dx.doi.org/10.2903/j.efsa.2018.5279 Text en © 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd 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
Rychen, Guido
Aquilina, Gabriele
Azimonti, Giovanna
Bampidis, Vasileios
Bastos, Maria de Lourdes
Bories, Georges
Chesson, Andrew
Cocconcelli, Pier Sandro
Flachowsky, Gerhard
Gropp, Jürgen
Kolar, Boris
Kouba, Maryline
López‐Alonso, Marta
López Puente, Secundino
Mayo, Baltasar
Ramos, Fernando
Saarela, Maria
Villa, Roberto Edoardo
Wallace, Robert John
Wester, Pieter
Martelli, Giovanna
Renshaw, Derek
López‐Gálvez, Gloria
Mantovani, Alberto
Safety and efficacy of Kelforce(®) (l‐glutamic acid, N,N‐diacetic acid, tetrasodium salt (GLDA‐Na(4))) as a feed additive for chickens for fattening
title Safety and efficacy of Kelforce(®) (l‐glutamic acid, N,N‐diacetic acid, tetrasodium salt (GLDA‐Na(4))) as a feed additive for chickens for fattening
title_full Safety and efficacy of Kelforce(®) (l‐glutamic acid, N,N‐diacetic acid, tetrasodium salt (GLDA‐Na(4))) as a feed additive for chickens for fattening
title_fullStr Safety and efficacy of Kelforce(®) (l‐glutamic acid, N,N‐diacetic acid, tetrasodium salt (GLDA‐Na(4))) as a feed additive for chickens for fattening
title_full_unstemmed Safety and efficacy of Kelforce(®) (l‐glutamic acid, N,N‐diacetic acid, tetrasodium salt (GLDA‐Na(4))) as a feed additive for chickens for fattening
title_short Safety and efficacy of Kelforce(®) (l‐glutamic acid, N,N‐diacetic acid, tetrasodium salt (GLDA‐Na(4))) as a feed additive for chickens for fattening
title_sort safety and efficacy of kelforce(®) (l‐glutamic acid, n,n‐diacetic acid, tetrasodium salt (glda‐na(4))) as a feed additive for chickens for fattening
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009609/
https://www.ncbi.nlm.nih.gov/pubmed/32625916
http://dx.doi.org/10.2903/j.efsa.2018.5279
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