Rychen Guido, Aquilina Gabriele, Azimonti Giovanna, Bampidis Vasileios, Bastos Maria De Lourdes, Bories Georges, Chesson Andrew, Cocconcelli Pier Sandro, Flachowsky Gerhard, Gropp Jürgen, Kolar Boris, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Mantovani Alberto, Mayo Baltasar, Ramos Fernando, Villa Roberto Edoardo, Wallace Robert John, Wester Pieter, Brozzi Rosella, Saarela Maria
EFSA J. 2018 Mar 20;16(3):e05204. doi: 10.2903/j.efsa.2018.5204. eCollection 2018 Mar.
Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of Alterion NE when used in feed for chickens for fattening and chickens reared for laying. Alterion NE is a preparation containing viable spores of DSM 29784 intended for use in feed for the target species at the recommended dose of 1 × 10 CFU/kg complete feedingstuffs. is a species considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strain to be conclusively established, evidence that the strain is not toxigenic and that it does not show resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach in the context of a previous opinion and since concerns are not expected from other components of the additive, the additive is presumed safe for all target species, consumers and the environment. In the same opinion, the FEEDAP Panel concluded that Alterion NE is not a dermal irritant but is irritant to eyes and should be considered a potential respiratory sensitiser. In the absence of data, no conclusion could be drawn on the dermal sensitisation of the additive. Alterion NE at the recommended dose 1 × 10 CFU/kg feed has the potential to be efficacious in minor poultry species for fattening and reared for laying. . DSM 29784 is compatible with the coccidiostats monensin sodium, narasin/nicarbazin, salinomycin sodium, lasalocid sodium, diclazuril, narasin, maduramicin ammonium, robenidine hydrochloride and decoquinate at the respective authorised levels.
应欧盟委员会的要求，欧洲食品安全局动物饲料添加剂和产品或物质专家小组被要求就Alterion NE用于育肥鸡和产蛋鸡饲料时的安全性和有效性发表科学意见。Alterion NE是一种含有DSM 29784活孢子的制剂，旨在以1×10 CFU/kg全价饲料的推荐剂量用于目标物种的饲料。 是欧洲食品安全局认为适用于安全评估的合格假定安全性（QPS）方法的物种，这要求菌株的身份得到最终确定，证明该菌株不产毒且对人和兽医重要的抗生素不显示抗性。在先前的意见中发现该菌株符合QPS方法的标准，并且由于预计添加剂的其他成分不会引起担忧，因此假定该添加剂对所有目标物种、消费者和环境都是安全的。在同一意见中，饲料添加剂和产品或物质专家小组得出结论，Alterion NE不是皮肤刺激物，但对眼睛有刺激性，应被视为潜在的呼吸道致敏剂。由于缺乏数据，无法就该添加剂的皮肤致敏性得出结论。以1×10 CFU/kg饲料的推荐剂量使用Alterion NE有可能对小型育肥和产蛋家禽有效。. DSM 29784与球虫抑制剂莫能菌素钠、那拉菌素/尼卡巴嗪、盐霉素钠、拉沙洛西钠、地克珠利、那拉菌素、马杜霉素铵、盐酸氯苯胍和癸氧喹酯在各自授权水平下兼容。
