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 29;16(3):e05220. doi: 10.2903/j.efsa.2018.5220. eCollection 2018 Mar.
Following a request from the European Commission, the EFSA 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 DSM 28343 when used in feed for calves for rearing. The additive is a preparation containing viable spores of a strain of . This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment. 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 the target species, consumers of products derived from animals fed the additive and the environment. In the same opinion, the FEEDAP Panel concluded that DSM 28343 is not an eye/skin irritant but should be considered a potential respiratory sensitiser and that no conclusion could be drawn on its skin sensitisation potential. These conclusions apply also to the current application. Insufficient evidence was provided to conclude on the efficacy of the additive in calves for rearing.
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（FEEDAP）被要求就DSM 28343用于犊牛饲养饲料时的安全性和有效性提供科学意见。该添加剂是一种含有某菌株活孢子的制剂。欧洲食品安全局认为该物种适用于安全性评估的合格假定（QPS）方法。在之前的一份意见中，该菌株被认定符合QPS方法的标准，并且由于预计该添加剂的其他成分不会引起担忧，因此假定该添加剂对目标物种、食用添加该添加剂的动物所产产品的消费者以及环境是安全的。在同一份意见中，FEEDAP专家小组得出结论，DSM 28343不是眼睛/皮肤刺激物，但应被视为潜在的呼吸道致敏剂，并且无法就其皮肤致敏潜力得出结论。这些结论同样适用于当前的申请。提供的证据不足，无法就该添加剂在犊牛饲养中的有效性得出结论。
