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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2018
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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. |
format | Online Article Text |
id | pubmed-7009609 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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