Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Kos Durjava Mojca, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Bories Georges, Finizio Antonio, Focks Andreas, Teodorovic Ivana, Manini Paola, Tarrés-Call Jordi
EFSA J. 2020 Jun 30;18(6):e06162. doi: 10.2903/j.efsa.2020.6162. eCollection 2020 Jun.
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.
聚山梨醇酯单月桂酸酯由山梨醇（及其酸酐）与源自椰子油的脂肪酸酯化而成。它目前在欧盟获得批准，拟用作技术添加剂（乳化剂功能组），用于所有动物种类的饲料中，最高浓度为每千克全价饲料85毫克。2019年，欧洲食品安全局动物饲料添加剂和产品或物质专家委员会（FEEDAP）发布了关于聚山梨醇酯单月桂酸酯安全性和有效性的意见。由于缺乏数据，FEEDAP专家委员会无法就该添加剂对环境的安全性得出结论。申请人提交了新的数据（归宿和降解以及生态毒性数据），本意见对这些数据进行了评估。结构相关化合物（聚山梨醇酯单硬脂酸酯和聚山梨醇酯三油酸酯）的吸收、分布、代谢和排泄表明该添加剂预计会部分代谢。此外，聚山梨醇酯单月桂酸酯和一些相关化合物易于生物降解。关于聚山梨醇酯单月桂酸酯对海洋甲壳类动物和海洋沉积物影响的现有数据有限，表明该添加剂的生态毒性较低，这与山梨醇酯的极低急性毒性一致。总体而言，FEEDAP专家委员会得出结论，聚山梨醇酯单月桂酸酯对陆地和水生环境不太可能构成风险。因此，根据既定的使用条件，预计使用该评估中的添加剂不会对环境造成安全担忧。
