Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Kos 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, Saarela Maria, Anguita Montserrat, Galobart Jaume, Holczknecht Orsolya, Manini Paola, Pizzo Fabiola, Tarrés-Call Jordi, Pettenati Elisa
EFSA J. 2020 Jun 26;18(6):e06167. doi: 10.2903/j.efsa.2020.6167. eCollection 2020 Jun.
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 Actisaf Sc 47 ( CNCM I-4407) as a zootechnical additive for calves for rearing. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for calves for rearing, consumers and the environment under the authorised conditions of use. The additive is not a skin or eye irritant. In the absence of data, no conclusions can be drawn on the dermal sensitisation potential of the additive. Inhalation exposure is unlikely. 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Actisaf Sc 47（CNCM I-4407）作为犊牛饲养用动物技术添加剂的授权续展申请评估提供科学意见。申请人已提供证据表明，目前市场上的添加剂符合现有授权条件。没有新的证据会导致FEEDAP专家小组重新考虑其先前的结论。因此，专家小组得出结论，在授权使用条件下，该添加剂对犊牛饲养、消费者和环境仍然是安全的。该添加剂不是皮肤或眼睛刺激物。由于缺乏数据，无法就该添加剂的皮肤致敏潜力得出结论。吸入暴露不太可能发生。本次授权续展申请未包括对原授权条件进行修订或补充的提议，而这些提议可能会影响添加剂的功效。因此，在授权续展的背景下，无需评估该添加剂的功效。
