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, Cocconcelli Pier Sandro, Glandorf Boet, Herman Lieve, Maradona Miguel Prieto, Saarela Maria, Anguita Montserrat, Galobart Jaume, Holczknecht Orsolya, Manini Paola, Pizzo Fabiola, Tarrés-Call Jordi, Pettenati Elisa
EFSA J. 2020 Nov 13;18(11):e06283. doi: 10.2903/j.efsa.2020.6283. eCollection 2020 Nov.
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 assessment of the application for renewal of authorisation of Calsporin ( DSM 15544) as a zootechnical additive for weaned piglets. 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 DSM 15544. is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established and the compliance with the other qualifications confirmed. Therefore, DSM 15544 is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from the other components of the additive, Calsporin is also considered safe for the target species, consumers of products derived from animals fed the additive and the environment. The additive is not a dermal/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. The present application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
应欧盟委员会的要求，动物饲料添加剂及产品或物质专家小组（FEEDAP）被要求就重新批准Calsporin（DSM 15544）作为断奶仔猪畜牧技术添加剂的申请进行科学评估。所评估的产品基于最初鉴定为[具体菌株名称未给出]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DSM 15544。[具体菌株名称未给出]被认为适用于安全评估的合格假定（QPS）方法。已确定活性成分的身份，并确认符合其他资质要求。因此，假定DSM 15544对目标物种、食用添加该添加剂的动物产品的消费者以及环境是安全的。由于预计该添加剂的其他成分不会引起担忧，因此Calsporin也被认为对目标物种、食用添加该添加剂的动物产品的消费者以及环境是安全的。该添加剂不是皮肤/眼睛刺激物或皮肤致敏剂，但应被视为呼吸道致敏剂。本次重新授权申请未包括对原授权条件进行修改或补充的提议，而这些修改或补充会对添加剂的功效产生影响。因此，在重新授权的背景下无需评估该添加剂的功效。
