Open AccessAssessment of the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine for all animal species
Author(s) -
Bampidis Vasileios,
Azimonti Giovanna,
Bastos Maria de Lourdes,
Christensen Henrik,
Dusemund Birgit,
Durjava Mojca Fašmon,
Kouba Maryline,
LópezAlonso Marta,
López Puente Secundino,
Marcon Francesca,
Mayo Baltasar,
Pechová Alena,
Petkova Mariana,
Ramos Fernando,
Sanz Yolanda,
Villa Roberto Edoardo,
Woutersen Ruud,
Brozzi Rosella,
Galobart Jaume,
Gregoretti Lucilla,
Innocenti Matteo L.,
Sofianidis Konstantinos,
Vettori Maria Vittoria,
LópezGálvez Gloria
Publication year - 2020
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2020.6337
Subject(s) - zinc , methionine , authorization , animal study , chelation , animal feed , chemistry , toxicology , pharmacology , medicine , food science , biochemistry , biology , organic chemistry , surgery , amino acid , computer science , computer security
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, HMTB a) 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 % HMTB a. 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.