Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Fašmon 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, Galobart Jaume, Holcznecht Orsolya, Vettori Maria Vittoria
EFSA J. 2022 Feb 24;20(2):e07161. doi: 10.2903/j.efsa.2022.7161. eCollection 2022 Feb.
Following a request from the European Commission, the FEEDAP Panel was asked to deliver a scientific opinion on the safety and efficacy of astaxanthin (ATX)-rich . The additive, belonging to the category 'sensory additives' and the functional group 'substances which, when fed to animals, add colours to food of animal origin' is intended to be used in feed for salmon and trout from an age of six months onwards up to a maximum content of 100 mg ATX/kg complete feed. The product is produced by the telemorph of , and it is declared to contain 995 g dried inactivated biomass and 5 g ascorbic acid per kg additive. The main active principle of the additive is ATX; however, the FEEDAP Panel noted that some other carotenoids are also present in lower quantities. The minimum ATX concentration is specified to be 5,000 mg per kg additive. The yeast is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment; therefore, the use of the production strain in the production of the additive would not raise any safety concern for the target species, the consumers of products from animals fed the additive and the environment. In the absence of a tolerance study with the additive, the FEEDAP Panel cannot conclude on the safety for the target species. In the absence of residue and toxicity data of ATX, no final conclusions on the safety for the consumer can be drawn. The FEEDAP Panel concluded that the additive is irritant to skin and eyes, and a skin and respiratory sensitiser, although exposure by inhalation is likely low. The FEEDAP Panel considers that ATX from the biomass does not pose a significant additional risk to the environment compared with other natural sources of ATX. In absence of adequate evidence, no conclusion can be made on the efficacy of the additive.
应欧盟委员会的要求，饲料添加剂、产品、动物营养物及动物源食品添加剂专家委员会（FEEDAP小组）被要求就富含虾青素（ATX）的[具体物质]的安全性和有效性发表科学意见。该添加剂属于“感官添加剂”类别，功能组为“喂食动物时能为动物源食品增添颜色的物质”，拟用于6月龄及以上鲑鱼和鳟鱼的饲料中，最高含量为每千克全价饲料含100毫克ATX。该产品由[具体真菌名称]的有性型生产，宣称每千克添加剂含有995克干燥灭活生物质和5克抗坏血酸。该添加剂的主要活性成分是ATX；然而，FEEDAP小组指出还存在其他一些含量较低的类胡萝卜素。规定添加剂中ATX的最低浓度为每千克5000毫克。欧洲食品安全局（EFSA）认为[具体酵母名称]适用于安全性评估的合格假定安全（QPS）方法；因此，在添加剂生产中使用该生产菌株不会对目标物种、食用添加该添加剂饲料的动物产品的消费者以及环境造成任何安全问题。由于缺乏该添加剂的耐受性研究，FEEDAP小组无法就其对目标物种的安全性得出结论。由于缺乏ATX的残留和毒性数据，无法就其对消费者的安全性得出最终结论。FEEDAP小组得出结论，该添加剂对皮肤和眼睛有刺激性，是皮肤和呼吸道致敏剂，尽管吸入暴露可能较低。FEEDAP小组认为，与其他天然ATX来源相比，生物质中的ATX对环境不会构成重大额外风险。由于缺乏充分证据，无法就该添加剂的有效性得出结论。
