Safety and efficacy of a feed additive consisting of iron (II) chelate of amino acids hydrate for all animal species

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of iron (II) chelate of amino acids hydrate for all animal species, brand name Availa® Fe, fo...

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Autores principales: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Fašmon Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa, Ruud Woutersen, Rosella Brozzi, Jaume Galobart, Lucilla Gregoretti, Matteo L Innocenti, Maria Vittoria Vettori, Gloria López‐Gálvez
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Lenguaje:EN
Publicado: Wiley 2021
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Acceso en línea:https://doaj.org/article/d20b3dafa5bc496390cbc3383551dbb3
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spelling oai:doaj.org-article:d20b3dafa5bc496390cbc3383551dbb32021-12-02T17:55:57ZSafety and efficacy of a feed additive consisting of iron (II) chelate of amino acids hydrate for all animal species1831-473210.2903/j.efsa.2021.6894https://doaj.org/article/d20b3dafa5bc496390cbc3383551dbb32021-11-01T00:00:00Zhttps://doi.org/10.2903/j.efsa.2021.6894https://doaj.org/toc/1831-4732Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of iron (II) chelate of amino acids hydrate for all animal species, brand name Availa® Fe, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein and with a minimum content of 9% iron. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to include a minimum specification for free amino acids of 18%; (iii) to introduce a tighter specification on the mineral content (iron), with an inclusion level of 9–10%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2017/2330. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of iron in the dust, it is not possible to make the assessment of the exposure by inhalation.EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMojca Fašmon DurjavaMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosYolanda SanzRoberto Edoardo VillaRuud WoutersenRosella BrozziJaume GalobartLucilla GregorettiMatteo L InnocentiMaria Vittoria VettoriGloria López‐GálvezWileyarticlenutritional additivecompounds of trace elementsiron (II) chelateAvaila® FesafetyefficacyNutrition. Foods and food supplyTX341-641Chemical technologyTP1-1185ENEFSA Journal, Vol 19, Iss 11, Pp n/a-n/a (2021)
institution DOAJ
collection DOAJ
language EN
topic nutritional additive
compounds of trace elements
iron (II) chelate
Availa® Fe
safety
efficacy
Nutrition. Foods and food supply
TX341-641
Chemical technology
TP1-1185
spellingShingle nutritional additive
compounds of trace elements
iron (II) chelate
Availa® Fe
safety
efficacy
Nutrition. Foods and food supply
TX341-641
Chemical technology
TP1-1185
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Fašmon Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Yolanda Sanz
Roberto Edoardo Villa
Ruud Woutersen
Rosella Brozzi
Jaume Galobart
Lucilla Gregoretti
Matteo L Innocenti
Maria Vittoria Vettori
Gloria López‐Gálvez
Safety and efficacy of a feed additive consisting of iron (II) chelate of amino acids hydrate for all animal species
description Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of iron (II) chelate of amino acids hydrate for all animal species, brand name Availa® Fe, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein and with a minimum content of 9% iron. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to include a minimum specification for free amino acids of 18%; (iii) to introduce a tighter specification on the mineral content (iron), with an inclusion level of 9–10%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2017/2330. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of iron in the dust, it is not possible to make the assessment of the exposure by inhalation.
format article
author EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Fašmon Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Yolanda Sanz
Roberto Edoardo Villa
Ruud Woutersen
Rosella Brozzi
Jaume Galobart
Lucilla Gregoretti
Matteo L Innocenti
Maria Vittoria Vettori
Gloria López‐Gálvez
author_facet EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Fašmon Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Yolanda Sanz
Roberto Edoardo Villa
Ruud Woutersen
Rosella Brozzi
Jaume Galobart
Lucilla Gregoretti
Matteo L Innocenti
Maria Vittoria Vettori
Gloria López‐Gálvez
author_sort EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
title Safety and efficacy of a feed additive consisting of iron (II) chelate of amino acids hydrate for all animal species
title_short Safety and efficacy of a feed additive consisting of iron (II) chelate of amino acids hydrate for all animal species
title_full Safety and efficacy of a feed additive consisting of iron (II) chelate of amino acids hydrate for all animal species
title_fullStr Safety and efficacy of a feed additive consisting of iron (II) chelate of amino acids hydrate for all animal species
title_full_unstemmed Safety and efficacy of a feed additive consisting of iron (II) chelate of amino acids hydrate for all animal species
title_sort safety and efficacy of a feed additive consisting of iron (ii) chelate of amino acids hydrate for all animal species
publisher Wiley
publishDate 2021
url https://doaj.org/article/d20b3dafa5bc496390cbc3383551dbb3
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