Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Diarr-Stop S Plus®, a mixture of sodium salt of ethylenediaminetetraacetic acid (Na2EDTA), a tannin-rich extract of Castanea sativa, thyme oil and oregano oil. The additive is intended for use with pigs for fattening at a recommended dose of 1,000 mg/kg feed to reduce the incidence of dysentery caused by Brachyspira hyodysenteriae and so improve performance. The additive is considered safe for pigs for fattening at the recommended dose of 1,000 mg/kg feed. None of the active constituents of Diarr-Stop S Plus® raised safety concerns for consumers when considered individually and at the concentrations delivered to feed using the recommended dose. As no interactions between constituents impacting on consumer safety are expected, the use of Diarr-Stop S Plus® in feed for pigs for fattening is considered safe for consumers without a withdrawal period. The additive should be considered as a skin and eye irritant, but the FEEDAP Panel could not conclude on the potential for dermal sensitisation. Because of the particle size, exposure of users by inhalation is considered unlikely. In the absence of appropriate data on the ecotoxicological effects of Na2EDTA, the assessment of risk for terrestrial and aquatic compartments cannot be completed. None of the submitted efficacy studies, all based on observations on commercial premises, comply with the minimum requirements for an experimental design for the demonstration of efficacy. Consequently, the FEEDAP Panel is unable to conclude on the efficacy of the additive Diarr-Stop S Plus® when used in feed for pigs for fattening.
|Titolo:||Safety and efficacy of Diarr‐Stop S Plus® (Na2EDTA, tannin‐rich extract of Castanea sativa, thyme oil and oregano oil) as a feed additive for pigs for fattening|
|Parole Chiave:||Na2EDTA; tannin; Castanea sativa; thyme oil; oregano oil; Brachyspira hyodysenteriae; pigs for fattening|
|Settore Scientifico Disciplinare:||Settore VET/07 - Farmacologia e Tossicologia Veterinaria|
|Data di pubblicazione:||2016|
|Digital Object Identifier (DOI):||10.2903/j.efsa.2016.4472|
|Appare nelle tipologie:||01 - Articolo su periodico|