Safety for the environment of sorbitan monolaurate as a feed additive for all animal species
2020
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) | Vasileios Bampidis | Giovanna Azimonti | Maria de Lourdes Bastos | Henrik Christensen | Birgit Dusemund | Mojca Kos Durjava | Maryline Kouba | Marta López‐Alonso | Secundino López Puente | Francesca Marcon | Baltasar Mayo | Alena Pechová | Mariana Petkova | Fernando Ramos | Yolanda Sanz | Roberto Edoardo Villa | Ruud Woutersen | Georges Bories | Antonio Finizio | Andreas Focks | Ivana Teodorovic | Paola Manini | Jordi Tarrés‐Call
Abstract The additive sorbitan monolaurate consists of sorbitol (and its anhydrides) esterified with fatty acids derived from coconut oil. It is currently authorised in the European Union and it is intended to be used as a technological additive (functional group of emulsifiers), in feedingstuffs for all animal species, at a maximum concentration of 85 mg/kg complete feed. In 2019, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of sorbitan monolaurate. Owing the lack of data, the FEEDAP Panel could not conclude on the safety of the additive for the environment. The applicant submitted new data (fate and degradation as well as ecotoxicity data) that were evaluated in the present opinion. The absorption, distribution, metabolism and excretion of structurally related compounds (sorbitan monostearate and sorbitan trioleate) indicate that the additive is expected to be partially metabolised. In addition, sorbitan monolaurate and some related compounds are readily biodegradable. The limited available data on the effects of sorbitan monolaurate in marine crustaceans and in marine sediment indicate that the ecotoxicity of the additive is low, in consistency with the very low acute toxicity of sorbitan esters. Overall, the FEEDAP Panel concludes that a risk of sorbitan monolaurate to terrestrial and aquatic environment is unlikely. Therefore, no safety concerns for the environment are expected from the use of the additive under assessment according to the established conditions of use.
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