Safety of a feed additive consisting of endo 1,4 -d-mannanase produced by Thermothelomyces thermophilus DSM 33149 (Natupulse? TS/TS L) for chickens and turkeys for fattening, minor poultry species for fattening and ornamental birds (BASF SE)

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 safety of a feed additive consisting of endo-1,4-beta-d-mannanase produced by Thermothelomyces thermophilus DSM 33149, intended for use as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, turkeys for fattening, minor poultry species for fattening and ornamental birds. The safety and efficacy of the additive have been already assessed previously; however, the FEEDAP Panel could not conclude on the safety of the additive for the target species, consumers and the users due to lack of reliable data on the potential genotoxicity of the additive. In the present assessment, the applicant submitted a new in vitro mammalian cell micronucleus test. After the assessment of the data newly submitted, the FEEDAP Panel concluded that the use of the feed additive in animal nutrition under the conditions of use proposed is of no concern for target species and consumer safety. The additive is not irritant to the eyes or skin. Owing to the proteinaceous nature of the active substance, the additive should be considered a respiratory sensitiser. The Panel cannot conclude on the potential of the additive to be a skin sensitiser.