Scientific Opinion on the safety and efficacy of selenium compounds (E8) as feed additives for all animal species: sodium selenite (coated granulated preparation), based on a dossier submitted by Doxal Italia S.p.A

Abstract

Scientific Opinion on the safety and efficacy of selenium compounds (E8) as feed additives for all animal species: sodium selenite (coated granulated preparation), based on a dossier submitted by Doxal Italia S.p.A. ABSTRACTSelenium is a trace element that is essential for vertebrates and involved in a series of vital metabolic functions. The additive, a coated granulated preparation of sodium selenite, consists of carrier granules to which the active compound, sodium selenite, is fixed using filming agents; it is manufactured with different selenium contents. Sodium selenite is considered to be a safe source of selenium for all animal species/categories, also when applied in coated granulated preparations. Based on extensive published literature data, the use of sodium selenite as a source of selenium in animal nutrition is considered to be safe for the consumer, provided that the total maximum authorised content of selenium in complete feed is respected. No concerns would arise from inhalation of selenium during the handling of the coated granulated preparation of sodium selenite owing to the very low estimated exposure. The coated granulated preparation of sodium selenite is considered to be an irritant to the skin, eyes and the respiratory system, and a skin sensitizer. Systemic exposure to selenium could result from dermal contact, particularly when cutaneous absorption of sodium selenite might be facilitated by skin damage; any dermal contact with the additive should be avoided. The use of sodium selenite in animal nutrition up to the maximum authorised content in feed would not raise concerns regarding the soil compartment, the ground or surface water. Concerning the marine sediments, given standard aquaculture practices and the low potential maximum concentration of selenium from fish feeds, any impact on the environment is unlikely. The coated granulated preparation of sodium selenite is an efficacious source of the essential trace element selenium for all animal species.

Safety and efficacy of sodium selenate as feed additive for ruminants

“…In previous opinions, the FEEDAP Panel assessed the safety for the environment of the inorganic source of sodium selenite when used in animal nutrition up to the maximum authorised content in feed and concluded that not concerns to the environment were expected (EFSA FEEDAP Panel, 2015, 2016a. The additive under assessment, sodium selenate for use in complementary feed for ruminants in the form of ruminal boluses, is intended to be a substitute for other authorised selenium additives and will not further increase the environmental burden of selenium.…”

Safety and efficacy of selenium compounds (E8) as feed additives for all animal species: sodium selenite, based on a dossier submitted by Retorte GmbH Selenium Chemicals and Metals

“…The FEEDAP Panel considered also a recently published book on selenium (Preedy, 2015) and found that there is no additional relevant information which would modify the EFSA previous opinions. The FEEDAP Panel recently adopted an opinion on sodium selenite (coated granulated preparation) in the frame of re-evaluation (EFSA FEEDAP Panel, 2015).…”

“…Symptoms of deficiency and toxicosis of selenium in farm animals are described in detail in a previous opinions of the FEEDAP Panel (EFSA, 2006(EFSA, , 2011EFSA FEEDAP Panel, 2015) and scientific reviews (e.g. McDowell, 2003;Suttle, 2010).…”

Safety and efficacy of selenium compounds (E8) as feed additives for all animal species: Sodium selenite, based on a dossier submitted by Todini and Co SpA

“…The FEEDAP Panel has already adopted two opinions on sodium selenite in the frame of re-evaluation (EFSA FEEDAP Panel, 2015, 2016.…”

“…3 Following the provisions of Article 10(1) of Regulation (EC) No 1831/2003, the compound was included in the EU Register of Feed Additives under the category "Nutritional additives" and the functional group "Compounds of trace elements". 4 The FEEDAP Panel has already adopted two opinions on sodium selenite in the frame of re-evaluation (EFSA FEEDAP Panel, 2015, 2016.…”