Scientific Opinion on the safety and efficacy of Hostazym C (endo-1,4-beta-glucanase) as feed additive for chickens for fattening, all other birds for fattening and piglets (weaned)

Zootechnical additives, digestibility enhancers, endo-1,4-beta-glucanase, poultry for fattening, piglets
First published in the EFSA Journal
1 July 2013
Adopted
17 April 2013
Type
Scientific Opinion

Abstract

Hostazym C is an enzyme preparation of endo-1,4-beta-glucanase produced by a non-genetically modified strain of Trichoderma citrinoviride. The results of an in vitro chromosomal aberration test and of an in vivo comet assay indicate the presence of genotoxic activity in the product. The tolerance studies provided in target species did not indicate any adverse effect of the additive. However, due to the genotoxic hazard from the product, the FEEDAP Panel cannot conclude on the safety of the additive for the target species. The results obtained in a repeated-dose oral toxicity study did not indicate any concern for consumer safety. However, the identity and fate of the substance causing the genotoxic effect is unknown; therefore, the source of the risk to the consumer cannot be established. Thus, the FEEDAP Panel cannot conclude on the safety of the additive for the consumer. The product should be considered a potential skin and eye irritant, and a potential skin and respiratory sensitiser. Due to the presence of genotoxic activity in the product, any level of exposure to the additive by any route is considered hazardous. No risks to the environment are expected to result from the use of the additive in feed, and, therefore, no further environmental risk assessment is required. Based on the results obtained in the efficacy studies, the FEEDAP Panel concludes that the additive has the potential to be efficacious in chickens for fattening at a dose of 500 CU/kg feed and in weaned piglets at 350 CU/kg. Conclusions on the efficacy can be extrapolated to minor poultry species for fattening.

Panel members at the time of adoption

Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf
Panel on Additives and Products or Substances used in Animal Feed
Contact
FEEDAP [at] efsa.europa.eu
doi
10.2903/j.efsa.2013.3207
EFSA Journal 2013;11(7):3207
Question Number
On request from
European Commission