Assessment of the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine for all animal species
Abstract The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine (Mintrex®Zn) for all animal species. The FEEDAP Panel has delivered thre...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2020-12-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2020.6337 |
| _version_ | 1818718715469889536 |
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| 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 Konstantinos Sofianidis 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 Konstantinos Sofianidis Maria Vittoria Vettori Gloria López‐Gálvez |
| author_sort | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) |
| collection | DOAJ |
| description | Abstract The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine (Mintrex®Zn) for all animal species. The FEEDAP Panel has delivered three opinions (during 2008 and 2009) on the safety and efficacy of the additive. The additive was authorised in 2010 as ‘Zinc chelate of hydroxy analogue of methionine’ containing 17.5−18 % zinc, 81 % (2‐hydroxy‐4‐methylthio)butanoic acid (dl‐methionine hydroxy analogue, HMTBa) and maximum 1% mineral oil. Following some modifications in the manufacturing process, the additive does not contain mineral oil and the applicant proposes the following specifications: ≥ 17 % zinc and ≥ 79 % HMTBa. The data provided indicate that the additive complies with the new specifications. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions on the safety for target species, consumers and environment. The applicant provided new studies on the effects of the additive on the respiratory tract and on skin and eyes. Data on the characterisation of the additive and the new studies on skin/eyes led the Panel to reconsider the safety for the user. Owing to the zinc and nickel content of Mintrex®Zn, the handling of the additive poses a risk to users by inhalation; the additive is not a skin or eye irritant but is considered a skin sensitiser. The present application did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive; therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. |
| first_indexed | 2024-12-17T19:55:27Z |
| format | Article |
| id | doaj.art-a48a9b218bd54fb49f099af903e33ac9 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-17T19:55:27Z |
| publishDate | 2020-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-a48a9b218bd54fb49f099af903e33ac92022-12-21T21:34:37ZengWileyEFSA Journal1831-47322020-12-011812n/an/a10.2903/j.efsa.2020.6337Assessment of the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine for all animal speciesEFSA 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. InnocentiKonstantinos SofianidisMaria Vittoria VettoriGloria López‐GálvezAbstract The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine (Mintrex®Zn) for all animal species. The FEEDAP Panel has delivered three opinions (during 2008 and 2009) on the safety and efficacy of the additive. The additive was authorised in 2010 as ‘Zinc chelate of hydroxy analogue of methionine’ containing 17.5−18 % zinc, 81 % (2‐hydroxy‐4‐methylthio)butanoic acid (dl‐methionine hydroxy analogue, HMTBa) and maximum 1% mineral oil. Following some modifications in the manufacturing process, the additive does not contain mineral oil and the applicant proposes the following specifications: ≥ 17 % zinc and ≥ 79 % HMTBa. The data provided indicate that the additive complies with the new specifications. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions on the safety for target species, consumers and environment. The applicant provided new studies on the effects of the additive on the respiratory tract and on skin and eyes. Data on the characterisation of the additive and the new studies on skin/eyes led the Panel to reconsider the safety for the user. Owing to the zinc and nickel content of Mintrex®Zn, the handling of the additive poses a risk to users by inhalation; the additive is not a skin or eye irritant but is considered a skin sensitiser. The present application did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive; therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.https://doi.org/10.2903/j.efsa.2020.6337nutritional additivecompounds of trace elementszinczinc chelate of hydroxy analogue of methionineMintrex®Znsafety |
| 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 Edoardo Villa Ruud Woutersen Rosella Brozzi Jaume Galobart Lucilla Gregoretti Matteo L. Innocenti Konstantinos Sofianidis Maria Vittoria Vettori Gloria López‐Gálvez Assessment of the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine for all animal species EFSA Journal nutritional additive compounds of trace elements zinc zinc chelate of hydroxy analogue of methionine Mintrex®Zn safety |
| title | Assessment of the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine for all animal species |
| title_full | Assessment of the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine for all animal species |
| title_fullStr | Assessment of the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine for all animal species |
| title_full_unstemmed | Assessment of the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine for all animal species |
| title_short | Assessment of the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine for all animal species |
| title_sort | assessment of the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine for all animal species |
| topic | nutritional additive compounds of trace elements zinc zinc chelate of hydroxy analogue of methionine Mintrex®Zn safety |
| url | https://doi.org/10.2903/j.efsa.2020.6337 |
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