Bampidis Vasileios, Azimonti Giovanna, de Lourdes Bastos Maria, Christensen Henrik, Dusemund Birgit, Kouba Maryline, Kos Durjava Mojca, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Brozzi Rosella, Galobart Jaume, Gregoretti Lucilla, Innocenti Matteo, López-Gálvez Gloria, Sofianidis Konstantinos, Vettori Maria Vittoria
EFSA J. 2019 May 10;17(5):e05699. doi: 10.2903/j.efsa.2019.5699. eCollection 2019 May.
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of erythrosine for ornamental fish. Erythrosine is a sensory additive belonging to the functional group colourants. In 2015, the FEEDAP Panel calculated the safe concentration in complete feed of ornamental fish to be 59 mg/kg complete feed. Considering that erythrosine contains 56.5% iodine, the safe level in feed of ornamental fish was recalculated taking into account the currently authorised maximum content of total iodine in complete feed and resulted to be 35 mg erythrosine/kg complete feed. The applicant submitted a new tolerance study in rainbow trout to demonstrate the safety of erythrosine for ornamental fish at doses higher than 59 mg/kg complete feed. The FEEDAP Panel noted that the study shows several limitations: (i) blood biochemistry was not measured, although required according to the guidance on the assessment of the safety of feed additives for the target species (ii) a low number of replicates (3 per treatment) which does not permit to obtain a reliable estimate and may not be sufficient to evidence differences between the groups (with no indication on the power of the study design), and (iii) the use level group was not included in the study design. Owing to these three limitations, the FEEDAP Panel is not in the position to change its previous conclusions that the safe level of erythrosine in ornamental fish is 59 mg/kg complete feed. This safe level is reduced to 35 mg erythrosine/kg complete feed, when considering the iodine content of erythrosine and the currently authorised maximum content of total iodine in complete feed for fish.
应欧盟委员会的要求，动物饲料添加剂及产品或物质专家小组（FEEDAP）被要求就丽红素用于观赏鱼的安全性发表科学意见。丽红素是一种属于功能性基团着色剂的感官添加剂。2015年，FEEDAP专家小组计算出观赏鱼全价饲料中的安全浓度为59毫克/千克全价饲料。考虑到丽红素含56.5%的碘，根据目前批准的全价饲料中总碘的最大含量重新计算了观赏鱼饲料中的安全水平，结果为35毫克丽红素/千克全价饲料。申请人提交了一项虹鳟鱼的新耐受性研究，以证明高于59毫克/千克全价饲料剂量的丽红素对观赏鱼的安全性。FEEDAP专家小组指出，该研究存在几个局限性：（i）未按照目标物种饲料添加剂安全性评估指南的要求测量血液生化指标；（ii）重复样本数量少（每个处理3个），无法获得可靠的估计值，可能不足以证明组间差异（未表明研究设计的效能）；（iii）研究设计中未包含使用水平组。由于这三个局限性，FEEDAP专家小组无法改变其先前的结论，即观赏鱼中丽红素的安全水平为59毫克/千克全价饲料。考虑到丽红素的碘含量以及目前批准的鱼类全价饲料中总碘的最大含量，该安全水平降至35毫克丽红素/千克全价饲料。
