Safety and efficacy of a feed additive consisting of copper chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.)
Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of copper chelate of ethylenediamine (Copper‐EDA‐Cl) as a feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal F...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2021-04-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2021.6541 |
| _version_ | 1818827391974244352 |
|---|---|
| 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 E Villa Ruud Woutersen Francesco Cubadda Andreas Focks Luca Tosti Montserrat Anguita Rosella Brozzi Jaume Galobart Matteo L Innocenti Gloria López‐Gálvez Konstantinos Sofianidis Maria Vittoria Vettori Lucilla Gregoretti |
| 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 E Villa Ruud Woutersen Francesco Cubadda Andreas Focks Luca Tosti Montserrat Anguita Rosella Brozzi Jaume Galobart Matteo L Innocenti Gloria López‐Gálvez Konstantinos Sofianidis Maria Vittoria Vettori Lucilla Gregoretti |
| author_sort | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) |
| collection | DOAJ |
| description | Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of copper chelate of ethylenediamine (Copper‐EDA‐Cl) as a feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) identified several issues related to the data provided concerning the chemical characteristics of the additive and, based on the information provided from an in vitro dissociation study, considered it unlikely that the additive consists only of copper mono‐chelate of EDA but of several coexisting (copper) species. Therefore, in the absence of adequate experimental data and owing to the uncertainties identified, the Panel cannot conclude on its identity and characterisation of the additive. The FEEDAP Panel concludes that the additive is safe for chickens for fattening and reared for laying/breeding but cannot conclude on the safety for other animal species/categories. The FEEDAP Panel cannot conclude on the safety of the additive for the consumer or the environment. The FEEDAP Panel concludes that handling the additive poses a risk to users by inhalation. The additive should be considered as non‐irritant for the skin but corrosive for the eyes and a skin sensitiser. The Panel notes the uncertainties on the genotoxicity potential of the additive that might have an impact on the conclusions on the safety for the user. The FEEDAP Panel concludes that the additive is efficacious in providing copper to meet the nutritional requirements of this trace element in all animal species. |
| first_indexed | 2024-12-19T00:42:49Z |
| format | Article |
| id | doaj.art-475a99c012284bdf965a64526c9a0715 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-19T00:42:49Z |
| publishDate | 2021-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-475a99c012284bdf965a64526c9a07152022-12-21T20:44:25ZengWileyEFSA Journal1831-47322021-04-01194n/an/a10.2903/j.efsa.2021.6541Safety and efficacy of a feed additive consisting of copper chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.)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 E VillaRuud WoutersenFrancesco CubaddaAndreas FocksLuca TostiMontserrat AnguitaRosella BrozziJaume GalobartMatteo L InnocentiGloria López‐GálvezKonstantinos SofianidisMaria Vittoria VettoriLucilla GregorettiAbstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of copper chelate of ethylenediamine (Copper‐EDA‐Cl) as a feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) identified several issues related to the data provided concerning the chemical characteristics of the additive and, based on the information provided from an in vitro dissociation study, considered it unlikely that the additive consists only of copper mono‐chelate of EDA but of several coexisting (copper) species. Therefore, in the absence of adequate experimental data and owing to the uncertainties identified, the Panel cannot conclude on its identity and characterisation of the additive. The FEEDAP Panel concludes that the additive is safe for chickens for fattening and reared for laying/breeding but cannot conclude on the safety for other animal species/categories. The FEEDAP Panel cannot conclude on the safety of the additive for the consumer or the environment. The FEEDAP Panel concludes that handling the additive poses a risk to users by inhalation. The additive should be considered as non‐irritant for the skin but corrosive for the eyes and a skin sensitiser. The Panel notes the uncertainties on the genotoxicity potential of the additive that might have an impact on the conclusions on the safety for the user. The FEEDAP Panel concludes that the additive is efficacious in providing copper to meet the nutritional requirements of this trace element in all animal species.https://doi.org/10.2903/j.efsa.2021.6541nutritional additivescompounds of trace elementscopper chelate of ethylenediamineCuEDAsafetyefficacy |
| spellingShingle | 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 E Villa Ruud Woutersen Francesco Cubadda Andreas Focks Luca Tosti Montserrat Anguita Rosella Brozzi Jaume Galobart Matteo L Innocenti Gloria López‐Gálvez Konstantinos Sofianidis Maria Vittoria Vettori Lucilla Gregoretti Safety and efficacy of a feed additive consisting of copper chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.) EFSA Journal nutritional additives compounds of trace elements copper chelate of ethylenediamine CuEDA safety efficacy |
| title | Safety and efficacy of a feed additive consisting of copper chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.) |
| title_full | Safety and efficacy of a feed additive consisting of copper chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.) |
| title_fullStr | Safety and efficacy of a feed additive consisting of copper chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.) |
| title_full_unstemmed | Safety and efficacy of a feed additive consisting of copper chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.) |
| title_short | Safety and efficacy of a feed additive consisting of copper chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.) |
| title_sort | safety and efficacy of a feed additive consisting of copper chelate of ethylenediamine for all animal species zinpro animal nutrition europe inc |
| topic | nutritional additives compounds of trace elements copper chelate of ethylenediamine CuEDA safety efficacy |
| url | https://doi.org/10.2903/j.efsa.2021.6541 |
| work_keys_str_mv | AT efsapanelonadditivesandproductsorsubstancesusedinanimalfeedfeedap safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT vasileiosbampidis safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT giovannaazimonti safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT mariadelourdesbastos safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT henrikchristensen safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT birgitdusemund safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT mojcafasmondurjava safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT marylinekouba safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT martalopezalonso safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT secundinolopezpuente safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT francescamarcon safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT baltasarmayo safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT alenapechova safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT marianapetkova safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT fernandoramos safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT yolandasanz safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT robertoevilla safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT ruudwoutersen safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT francescocubadda safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT andreasfocks safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT lucatosti safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT montserratanguita safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT rosellabrozzi safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT jaumegalobart safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT matteolinnocenti safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT glorialopezgalvez safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT konstantinossofianidis safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT mariavittoriavettori safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc AT lucillagregoretti safetyandefficacyofafeedadditiveconsistingofcopperchelateofethylenediamineforallanimalspecieszinproanimalnutritioneuropeinc |