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, Saarela Maria, Brozzi Rosella, Galobart Jaume, Pettenati Elisa, Revez Joana
EFSA J. 2021 Jun 16;19(6):e06620. doi: 10.2903/j.efsa.2021.6620. eCollection 2021 Jun.
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 extension of use of the feed additive consisting of CECT 5940 (tradename: Ecobiol) to turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for laying and ornamental birds (except for reproduction). The product under assessment is based on viable spores of a strain originally identified as . During the course of the current assessment, the active agent has been reclassified as CECT 5940. The bacterial species is considered suitable for the qualified presumption of safety (QPS) approach. The identity of the active agent was established and the compliance with the other qualifications confirmed. Therefore, CECT 5940 is presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, the additive Ecobiol is also considered safe for the target species, consumers and the environment. The additive is not irritant to skin/eye or a skin sensitiser, but should be considered a respiratory sensitiser. The efficacy data previously evaluated allowed the Panel to conclude that the additive has the potential to be efficacious at the level of 1 × 10 CFU/kg feed in turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for laying and ornamental birds (except for reproduction).
应欧盟委员会要求,动物饲料添加剂及产品或物质专家委员会(FEEDAP)被要求就一种由CECT 5940(商品名:Ecobiol)组成的饲料添加剂在育肥火鸡、种用火鸡、育肥小型家禽品种、产蛋小型家禽品种和观赏鸟(繁殖用途除外)中的使用范围扩展提供科学意见。所评估的产品基于最初鉴定为[未提及具体名称]的菌株的活孢子。在本次评估过程中,活性成分已重新分类为CECT 5940。该细菌物种被认为适用于合格安全推定(QPS)方法。已确定活性成分的身份并确认符合其他条件。因此,推定CECT 5940对目标物种、消费者和环境是安全的。由于预计该添加剂的其他成分不会引起担忧,因此添加剂Ecobiol也被认为对目标物种、消费者和环境是安全的。该添加剂对皮肤/眼睛无刺激性,也不是皮肤致敏剂,但应被视为呼吸道致敏剂。先前评估的功效数据使专家委员会得出结论,该添加剂在育肥火鸡、种用火鸡、育肥小型家禽品种、产蛋小型家禽品种和观赏鸟(繁殖用途除外)的饲料中添加量为1×10 CFU/kg时具有潜在功效。