Safety and efficacy of Levucell® SC (Saccharomyces cerevisiae CNCM I-1077) as a feed additive for dairy cows, cattle for fattening, minor ruminant species and camelids
Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Levucell® SC for dairy cows, cattle for fattening, all minor ruminant species and camelids. The additive consists of viable cells of a strain of Saccharomyces cerevisae and is sold in three formulations. The FEEDAP Panel considers that the three available formulations are equivalent when used to deliver the same dose. The active agent fulfils the requirements of the qualified presumption of safety approach to the assessment of safety and since no concerns are expected from other components, Levucell® SC can be presumed safe for target animals, consumers of products from treated animals and the environment. Levucell® SC is not a skin irritant or sensitiser but is an eye irritant. Inhalation exposure is unlikely. Encapsulation is not expected to introduce hazards for users. The FEEDAP Panel is not in the position to conclude on the efficacy of Levucell® SC for dairy cows, minor dairy ruminant species or dairy camelids. Levucell® SC has a potential to improve the performance of cattle raised for fattening when supplied at a minimum dose of 8 × 109 CFU/head and day which would approximate to 6 × 108 CFU/kg complete feed. This conclusion is extended to minor ruminant species and camelids reared for meat production at the same minimum dose of 6 × 108 CFU/kg complete feed.
This scientific opinion has been amended following the adoption of the decision of the Commission on confidentiality claims submitted by the applicant, in accordance with Article 8(6) and Article 18 of Regulation (EC) No 1831/2003. The modified sections are indicated in the text.