Modification of the terms of authorisation of zinc‐l‐selenomethionine as a feed additive for all animal species (Zinpro Animal Nutrition (Europe), Inc.)
2023
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) | Vasileios Bampidis | Giovanna Azimonti | Maria de Lourdes Bastos | Henrik Christensen | Mojca Durjava | Birgit Dusemund | Maryline Kouba | Marta López‐Alonso | Secundino López Puente | Francesca Marcon | Baltasar Mayo | Alena Pechová | Mariana Petkova | Fernando Ramos | Roberto Edoardo Villa | Ruud Woutersen | Jaume Galobart | Matteo Lorenzo Innocenti | Maria Vittoria Vettori | Anita Radovnikovic
Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a new preparation of zinc‐l‐selenomethionine, with selenium content of 4%, as a nutritional feed additive for all animal species. Zinc‐l‐selenomethionine is already authorised for use in all animal species (3b818). Current authorisation defines the additive as ‘Solid preparation of zinc‐l‐selenomethionine with a selenium content of 1–2 g/kg’. The applicant developed a new preparation of zinc‐l‐selenomethionine containing a minimum of 40 g Se/kg and seeks to modify the current authorisation. The FEEDAP Panel concluded that the newly proposed preparation is considered safe for all animal species. The FEEDAP Panel recommends adding, to the currently existing authorisation, a new preparation (40–46 g Se/kg) and not the range proposed by the applicant (1–46 g Se/kg), since no characterisation data on the intermediate preparation range (from 2 to 40 g Se/kg) have been provided. The use of the new preparation (minimum 40 g Se/kg) of zinc‐l‐selenomethionine in animal nutrition is of no concern for consumer safety. The newly proposed preparation presents a risk by inhalation; it is not irritant to eyes or skin. No conclusion can be reached regarding dermal sensitisation. The previous conclusion by the Panel on the safety for the environment remains unchanged. The Panel concluded that the modification request has no impact on efficacy.
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