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 28;16(3):e05219. doi: 10.2903/j.efsa.2018.5219. eCollection 2018 Mar.
Following a request from the European Commission, the European Food Safety Authority (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 Calsporin when used in feed for pigs for fattening. The additive contains viable spores of a single strain of . This species is considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment. This approach 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 previous opinions and since concerns are not expected from other components of the additive, Calsporin is presumed safe for all target species, including pigs, consumers of products derived from animals treated and for the environment. In a previous opinion, the Panel also concluded that the additive is not a dermal/eye irritant or a skin sensitiser but should be considered a potential respiratory sensitiser. The use of the additive in pigs for fattening is considered unlikely to introduce hazards for users of the product not already considered as part of the first assessment. Therefore, the conclusions reached apply to the current application. Based on the results of the pooled analysis of four studies, the Panel on additives and products or substances used in animal feed (FEEDAP) concludes that Calsporin has the potential to improve performance of pigs for fattening at 1.5 × 10 CFU/kg feed.
应欧盟委员会的要求，欧洲食品安全局（EFSA）动物饲料添加剂及产品或物质专家小组被要求就Calsporin用于育肥猪饲料时的安全性和有效性发表科学意见。该添加剂含有单一菌株的活孢子。EFSA认为该物种适用于安全性评估的合格假定安全（QPS）方法。这种方法要求菌株的身份得到最终确定，有证据表明该菌株不产毒且对人类和兽医重要的抗生素不具有抗性。在之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Calsporin对所有目标物种都是安全的，包括猪、食用经处理动物产品的消费者以及环境。在之前的一份意见中，专家小组还得出结论，该添加剂不是皮肤/眼睛刺激物或皮肤致敏剂，但应被视为潜在的呼吸道致敏剂。在育肥猪中使用该添加剂不太可能给尚未被视为首次评估一部分的产品使用者带来危害。因此，得出的结论适用于当前的申请。基于四项研究的汇总分析结果，动物饲料添加剂及产品或物质专家小组（FEEDAP）得出结论，Calsporin在饲料中添加量为1.5×10 CFU/kg时具有提高育肥猪性能的潜力。
