Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Durjava Mojca Fašmon, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Villa Roberto Edoardo, Woutersen Ruud, Anguita Montserrat, Bozzi Cionci Nicole, Brozzi Rosella, Innocenti Matteo Lorenzo, Pettenati Elisa, Revez Joana, Tarrés-Call Jordi, Valeri Piera, García-Cazorla Yolanda
EFSA J. 2024 Jul 25;22(7):e8910. doi: 10.2903/j.efsa.2024.8910. eCollection 2024 Jul.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of a preparation of dried cells of CNCM I-4407 (Actisaf® Sc 47) as a zootechnical additive for rabbits for fattening and non-food producing rabbits. The applicant provided evidence that the additive currently in the market complies with the existing terms of the authorisation. The Panel concluded that the additive remains safe for the target species, consumers and the environment. Regarding the safety for the user, the additive is not a skin or eye irritant. However, it should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. 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，欧洲食品安全局被要求就CNCM I-4407（Actisaf® Sc 47）干燥细胞制剂作为育肥兔和非食用兔的动物营养添加剂续期授权申请进行科学评估。申请人提供了证据，证明市场上现有的添加剂符合现有授权条款。专家组得出结论，该添加剂对目标物种、消费者和环境仍然是安全的。关于对使用者的安全性，该添加剂不是皮肤或眼睛刺激物。然而，应将其视为潜在的皮肤和呼吸道致敏剂，任何通过皮肤和呼吸道的接触都被视为有风险。本次续期授权申请未包括对原授权条件进行修订或补充的提议，这些提议可能会影响添加剂的功效。因此，在续期授权的背景下，无需评估该添加剂的功效。
