Open AccessAssessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species
Author(s) -
Bampidis Vasileios,
Azimonti Giovanna,
Bastos Maria de Lourdes,
Christensen Henrik,
Dusemund Birgit,
Kouba Maryline,
Kos Durjava Mojca,
LópezAlonso Marta,
López Puente Secundino,
Marcon Francesca,
Mayo Baltasar,
Pechová Alena,
Petkova Mariana,
Ramos Fernando,
Sanz Yolanda,
Villa Roberto Edoardo,
Woutersen Ruud,
Flachowsky Gerhard,
Gropp Jürgen,
Cubadda Francesco,
LópezGálvez Gloria,
Mantovani Alberto
Publication year - 2019
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.2019.5539
Subject(s) - selenium , authorization , animal feed , animal species , feed additive , microbiology and biotechnology , zoology , toxicology , biology , food science , medicine , chemistry , computer science , computer security , organic chemistry , broiler
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 organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel ® ) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was initially authorised in 2007 with a content of 2,000–2,400 mg Se/kg (97–99 % of organic selenium) and in 2017 the authorisation was further amended to introduce a selenium range of 2,000–3,500 mg Se/kg. Additionally, in 2013, the initial authorising Regulation was modified to introduce a maximum supplementation selenium from this additive in feed (0.2 mg Se from Alkosel ® /kg feed). The evidence provided indicates that the additive currently in the market complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions in the safety for target species, consumers and environment. In particular, the Panel confirms that the use of Alkosel ® in animal nutrition does not pose a risk to consumers provided that the maximum selenium supplementation of 0.2 mg/kg feed from Alkosel ® is not exceeded, yet respecting the maximum total selenium in feed of 0.5 mg/kg. Data on the characterisation of the additive and studies on skin/eyes effects led the Panel reconsider the safety for the user, concluding that Alkosel ® is (i) hazardous upon inhalation, (ii) non‐irritant to skin and considered irritant for the eyes and mucosae, and (iii) a dermal sensitiser and likely a respiratory sensitiser. A recommendation regarding the denomination of the additive under assessment was proposed by the Panel.