Villa Roberto Edoardo, Azimonti Giovanna, Bonos Eleftherios, Christensen Henrik, Durjava Mojca, Dusemund Birgit, Gehring Ronette, Glandorf Boet, Kouba Maryline, López-Alonso Marta, Marcon Francesca, Nebbia Carlo, Pechová Alena, Prieto-Maradona Miguel, Röhe Ilen, Theodoridou Katerina, Bampidis Vasileios, Dierick Noël, Anguita Montserrat, Brozzi Rosella, Innocenti Matteo L, Pizzo Fabiola, Tarrés-Call Jordi, Amaduzzi Angelica
EFSA J. 2025 Jun 12;23(6):e9479. doi: 10.2903/j.efsa.2025.9479. eCollection 2025 Jun.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 25-hydroxycholecalciferol as a nutritional feed additive for salmonids, other fish species and all other animal species (except poultry, pigs and all ruminants). The additive is currently authorised for use in pigs, poultry and ruminants. The additive is safe for salmonids, other fish species and all other animal species (other than pigs, poultry and ruminants) at the maximum recommended use levels (in mg 25-OH-D/kg complete feed): 0.8 for salmonids, 0.075 in other fish species and 0.05 for all other animal species (other than poultry, pigs and ruminants). The use of 25-OH-D in feed for all animal species under the proposed conditions of use is considered safe for the consumers and the environment. With regard to the safety of users, the additive is not irritant to the skin or eyes. No conclusion on its potential to be a skin sensitiser or on its effects on the respiratory system can be reached due to the absence of data. The FEEDAP Panel concludes that 25-OH-D, when used as a nutritional additive in feed, is efficacious for all animal species.
应欧盟委员会的要求,欧洲食品安全局(EFSA)被要求就25-羟基胆钙化醇作为鲑鱼、其他鱼类及所有其他动物物种(家禽、猪和所有反刍动物除外)的营养性饲料添加剂的安全性和有效性发表科学意见。该添加剂目前已获批准用于猪、家禽和反刍动物。在最大推荐使用水平(以每千克全价饲料中25-羟基维生素D的毫克数计)下,该添加剂对鲑鱼、其他鱼类及所有其他动物物种(猪、家禽和反刍动物除外)是安全的:鲑鱼为0.8,其他鱼类为0.075,所有其他动物物种(家禽、猪和反刍动物除外)为0.05。在拟议的使用条件下,在所有动物物种的饲料中使用25-羟基维生素D被认为对消费者和环境是安全的。关于使用者的安全性,该添加剂对皮肤或眼睛无刺激性。由于缺乏数据,无法就其成为皮肤致敏剂的可能性或其对呼吸系统的影响得出结论。饲料添加剂和动物营养产品专家小组得出结论,25-羟基维生素D用作饲料中的营养添加剂时,对所有动物物种均有效。