Assessment of the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine for all animal species | European Food Safety Authority Pasar al contenido principal

Assessment of the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine for all animal species

Metadata

Panel members at the time of adoption

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 and Ruud Woutersen.
Legal notice: Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by the European Commission. The full output has been shared with the European Commission, EU Member States and the applicant. The blackening will be subject to review once the decision on the confidentiality requests is adopted by the European Commission.

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.

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