Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, 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, Bories Georges, Brantom Paul, Renshaw Derek, Schlatter Josef Rudolf, Ackerl Reinhard, Holczknecht Orsolya, Steinkellner Hans, Vettori Maria Vittoria, Gropp Jürgen
EFSA J. 2019 Dec 18;17(12):e05920. doi: 10.2903/j.efsa.2019.5920. eCollection 2019 Dec.
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 and efficacy of astaxanthin-dimethyldisuccinate (ATX-DMDS) for salmonids, crustaceans and other fish. The applicant has provided evidence that ATX-DMDS currently on the market complies with the conditions of authorisation for salmon and trout. ATX and ATX-DMDS are safe for salmonids, crustaceans and fish up to 100 mg ATX/kg complete diet, corresponding to 138 mg ATX-DMDS/kg. The FEEDAP Panel re-assessed the toxicological profile of ATX based on data already considered in 2014, the literature review performed by the applicant and the data available in the context of an EFSA public call for data on ATX. The acceptable daily intake (ADI) of 0.2 mg astaxanthin/kg body weight (bw) per day obtained by applying an uncertainty factor of 200 to a lowest observed adverse effect level (LOAEL) of 40 mg/kg bw per day for the increased incidence of multinucleated hepatocytes observed in a 2-year carcinogenicity study replaces the one of 0.034 mg/kg bw established by the FEEDAP Panel in 2014. The use of ATX-DMDS in the nutrition of salmonids, other fish and crustaceans up to the maximum permitted dietary level is of no concern for the safety of the consumer. No dermal or ocular risk for the users is likely to occur under practical conditions. In the absence of inhalation toxicology study, the Panel is not in the position to establish the inhalation toxicity of the additive. The use of synthetic ATX-DMDS does not pose a significant additional risk to the environment compared with natural astaxanthin. ATX-DMDS is efficacious in colouring the flesh of salmonids and other fish. ATX-DMDS is an effective pigment for crustaceans at the proposed conditions of use.
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）被要求就虾青素二甲基琥珀酸酯（ATX-DMDS）对鲑鱼、甲壳类动物和其他鱼类的安全性和有效性发表科学意见。申请人已提供证据表明，目前市场上的ATX-DMDS符合鲑鱼和鳟鱼的授权条件。ATX和ATX-DMDS对鲑鱼、甲壳类动物和鱼类是安全的，在全价饲料中ATX的含量最高可达100 mg/kg，相当于138 mg ATX-DMDS/kg。FEEDAP专家小组根据2014年已考虑的数据、申请人进行的文献综述以及欧洲食品安全局（EFSA）公开征集ATX数据时获得的数据，重新评估了ATX的毒理学特征。通过将200的不确定性系数应用于一项为期两年的致癌性研究中观察到的多核肝细胞发生率增加的最低观察到有害作用水平（LOAEL），即每天40 mg/kg体重，得出虾青素的每日可接受摄入量（ADI）为0.2 mg/kg体重/天，取代了FEEDAP专家小组在2014年确定的0.034 mg/kg体重。在鲑鱼、其他鱼类和甲壳类动物的营养中使用ATX-DMDS，直至允许的最高膳食水平，对消费者的安全没有影响。在实际使用条件下，使用者不太可能面临皮肤或眼睛方面的风险。由于缺乏吸入毒理学研究，专家小组无法确定该添加剂的吸入毒性。与天然虾青素相比，合成ATX-DMDS的使用对环境不会造成显著的额外风险。ATX-DMDS在使鲑鱼和其他鱼类的鱼肉着色方面是有效的。在所建议的使用条件下，ATX-DMDS对甲壳类动物是一种有效的色素。
