欧盟就添加剂贝莱斯芽孢杆菌DSM 15544的授权延期申请发布意见

 

　　经过评估，专家组得出结论，在授权使用条件下，贝莱斯芽孢杆菌DSM 15544作为添加剂对目标物种、消费者和环境都是安全的。该添加剂不是皮肤和眼睛刺激物或皮肤致敏剂，但应视为呼吸道致敏剂。本授权续签的申请中未包含修改或补充可能影响添加剂功效的原始授权条件的提案。因此，无需在授权更新的情况下评估添加剂的功效。

 

　　部分原文报道如下：

 

　　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? (Bacillus velezensisDSM 15544) as a zootechnical additive for weaned piglets. The product under assessment is based on viable spores of a strain originally identified as Bacillus subtilis. During the course of the current assessment, the active agent has been reclassified as Bacillus velezensisDSM 15544. B. velezensis 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 //confirm/i/ied. Therefore, B. velezensisDSM 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.