Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

nutritional additive, compounds of trace elements, selenium, selenised yeast, Saccharomyces cerevisiae NCYC R397, ALKOSEL®, safety
First published in the EFSA Journal
11 January 2019
Adopted
27 November 2018
Type
Scientific Opinion

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 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.

Panel members at the time of adoption

Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Maryline Kouba, Mojca Kos Durjava, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2019.5539
EFSA Journal 2019;17(1):5539
Question Number
On request from
European Commission
Disclaimer
Relevant information or parts of this scientific output have been blackened in accordance with the European Commission decision on the confidentiality requests formulated by the applicant. The full output has been shared with the European Commission, EU Member States and the applicant.