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

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.

Assessment of the feed additive consisting of Saccharomyces cerevisiae CNCM I‐4407 (Actisaf® Sc 47) for rabbits for fattening and non‐food producing rabbits for the renewal of its authorisation (S. I. Lesaffre)

“…In its previous opinions, the FEEDAP Panel concluded that, following the qualified presumption of safety (QPS) approach to the safety assessment, S. cerevisiae CNCM I‐4407 is safe for the target species, consumers and the environment (EFSA FEEDAP Panel, 2012 , 2020 ). The safety for the user was evaluated by EFSA FEEDAP Panel in previous assessments (EFSA FEEDAP Panel, 2012 , 2018a , 2019 , 2020 ). The FEEDAP Panel concluded that Actisaf® Sc 47 in any form is not a skin or eye irritant and no conclusions could be drawn on the dermal sensitisation potential of the additive.…”

“…In previous assessments for the renewal of the authorisation of the additive, two literature searches on the safety of the product covering the periods 2007–2016 (EFSA FEEDAP Panel, 2018a ) and 2016–2019 (EFSA FEEDAP Panel, 2020 ) were evaluated by the FEEDAP Panel. These searches did not reveal any safety issue related to the additive under assessment.…”

“…The additive is authorised for use in feed as a zootechnical additive (4b1702) under the functional group digestibility enhancer for horses, 5 and under the functional group gut flora stabilisers for calves for rearing; 6 rabbits for fattening and non‐food producing rabbits; 7 lambs for fattening, dairy goats and dairy sheep, pigs for fattening, dairy buffaloes 8 and piglets (weaned), sows and dairy cows. 9 EFSA has issued an opinion on the safety and efficacy of this product for rabbits for fattening and non‐food producing rabbits (EFSA FEEDAP Panel, 2012 ) and for several other species (EFSA, 2006a , 2006b , 2006c , 2007a , 2007b , 2008 , 2010 ; EFSA FEEDAP Panel, 2018a , 2018b , 2019 , 2020 ).…”

Efficacy of the feed additive consisting of Saccharomyces cerevisiae CNCM I‐4407 (Actisaf® Sc47) for cattle for fattening (Lesaffre International)

“…EFSA issued several opinions on the safety and efficacy of this additive (EFSA, 2006a , 2006b , 2006c , 2007a , 2007b , 2008 , 2010 ; EFSA FEEDAP Panel, 2012 , 2018a , 2018b , 2019 , 2020 ).…”