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 (Saccharomyces cerevisiae 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.

Assessment of the application for renewal of the authorisation of Actisaf® Sc 47 (Saccharomyces cerevisiae CNCM I-4407) as a feed additive for calves for rearing / V. Bampidis, G. Azimonti, M.D.L. Bastos, H. Christensen, B. Dusemund, M. Kos Durjava, M. Kouba, M. Lopez-Alonso, S. Lopez Puente, F. Marcon, B. Mayo, A. Pechova, M. Petkova, F. Ramos, Y. Sanz, R.E. Villa, R. Woutersen, M. Saarela, M. Anguita, J. Galobart, O. Holczknecht, P. Manini, F. Pizzo, J. Tarres-Call, E. Pettenati. - In: EFSA JOURNAL. - ISSN 1831-4732. - 18:6(2020 Jun 26). [10.2903/j.efsa.2020.6167]

Assessment of the application for renewal of the authorisation of Actisaf® Sc 47 (Saccharomyces cerevisiae CNCM I-4407) as a feed additive for calves for rearing

R.E. Villa;
2020

Abstract

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 (Saccharomyces cerevisiae 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.
Actisaf ®; Sc47; calves for rearing; Saccharomyces cerevisiae CNCM I-4407; safety; zootechnical additive;
Settore VET/07 - Farmacologia e Tossicologia Veterinaria
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/828665
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